Food Labeling: Revision of the Nutrition and Supplement Facts Labels, 11879-11987 [2014-04387]

Download as PDF Vol. 79 Monday, No. 41 March 3, 2014 Part II Department of Health and Human Services mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Food and Drug Administration 21 CFR Part 101 Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Proposed Rule VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\03MRP2.SGM 03MRP2 11880 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Reduction Act of 1995’’ section of this document). Food and Drug Administration Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. 21 CFR Part 101 [Docket No. FDA–2012–N–1210] RIN 0910–AF22 Food Labeling: Revision of the Nutrition and Supplement Facts Labels AGENCY: Food and Drug Administration, HHS. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The updated information is consistent with current data on the associations between nutrients and chronic diseases or health-related conditions, reflects current public health conditions in the United States, and corresponds to new information on consumer behavior and consumption patterns. We are proposing to update the list of nutrients that are required or permitted to be declared; provide updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; amend requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establish nutrient reference values specifically for these population subgroups; and revise the format and appearance of the Nutrition Facts label. DATES: Submit either electronic or written comments on the proposed rule by June 2, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 2, 2014 (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). See section III of this document for the proposed effective date of a final rule based on this proposed rule. ADDRESSES: You may submit comments, identified by Docket No. FDA–2012–N– 1210, and/or Regulatory Information Number (RIN) 0910–AF22, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the ‘‘Paperwork VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5360 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA–2012–N–1210 and RIN 0910–AF22 for this rulemaking. All comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food Safety and Applied Nutrition (HFS– 830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–5429, email: NutritionProgramStaff@fda.hhs.gov. With regard to the information collection: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400T, Rockville, MD 20850, Domini.bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary I. Background A. Legal Authority B. Need To Update the Nutrition Facts and Supplement Facts Labels 1. Rates of Chronic Disease 2. Dietary Recommendations, Consensus Reports, and National Survey Data 3. Consumer Use and Understanding of the Nutrition Facts Label 4. Other Relevant Considerations 5. Citizen Petitions 6. Advance Notices of Proposed Rulemaking (ANPRMs) PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 7. Impact on Other Regulations C. Factors for Mandatory or Voluntary Declaration of Non-Statutory Nutrients 1. Factors Considered 2. Approach for Mandatory Declaration 3. Approach for Voluntary Declaration II. The Proposed Rule A. Calories 1. Calories From Fat 2. Calories From Saturated Fat 3. Two Thousand Calories as the Reference Caloric Intake Level 4. Percent DV Declaration for Calories B. Fat 1. Total Fat 2. Saturated Fat 3. Trans Fat 4. Polyunsaturated Fat 5. Monounsaturated Fat C. Cholesterol 1. Mandatory Declaration 2. DRV D. Carbohydrate 1. Total Carbohydrate 2. Sugars 3. Added Sugars 4. Sugar Alcohols 5. Dietary Fiber 6. Other Carbohydrate E. Protein 1. Mandatory and Voluntary Declaration 2. Analytical Methods 3. DRV F. Sodium 1. Mandatory Declaration 2. DRV G. Fluoride 1. Voluntary Declaration 2. DRV H. Essential Vitamins and Minerals of Public Health Significance 1. Essential Vitamins and Minerals That Are Mandatory 2. Essential Vitamins and Minerals That Are Voluntary 3. Other Essential Vitamins and Minerals 4. Summary I. Reference Daily Intakes for Vitamins and Minerals 1. Need To Update RDIs 2. Approach To Setting RDIs: EAR Versus RDA 3. Approach To Setting RDIs: Adequate Intake 4. Approach To Setting RDIs: Tolerable Upper Intake Level 5. Approach To Setting RDIs: PopulationWeighted Versus Population-Coverage 6. Declaration of the Absolute Amounts of Vitamins and Minerals 7. Issues Concerning Specific Vitamins and Minerals J. Units of Measure, Analytical Methods, and Terms for Vitamins and Minerals 1. Sodium, Potassium, Copper, and Chloride 2. Folate and Folic Acid 3. Vitamins A, D, and E K. Labeling of Foods for Infants, Young Children, and Pregnant or Lactating Women 1. Age Range for Infants and Young Children 2. Mandatory Declaration of Calories and Statutorily Required Nutrients E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 3. Declaration of Non-Statutory Nutrients Other Than Essential Vitamins and Minerals 4. Declaration of Essential Vitamins and Minerals 5. DRVs and RDIs for Infants 7 Through 12 Months of Age 6. DRVs and RDIs for Children 1 Through 3 Years of Age 7. DRVs and RDIs for Pregnant and Lactating Women L. Dietary Supplements 1. Mandatory Dietary Ingredients 2. Folate and Folic Acid 3. Units of Measure 4. Order of Nutrients Declared on the Label 5. Subpopulations 6. Footnote M. Format 1. Increasing the Prominence of Calories and Serving Size 2. Changing the Order of the ‘‘Serving Size’’ and ‘‘Servings Per Container’’ Declarations and Increasing the Prominence of ‘‘Servings Per Container’’ 3. Right-Justifying the Quantitative Amounts Declared in the ‘‘Serving Size’’ Statement 4. Changing the ‘‘Amount Per Serving’’ Statement 5. Declaration of ‘‘Calories From Fat’’ 6. Presentation of Percent DVs 7. Placement of ‘‘Added Sugars’’ 8. Declaration of Absolute Amounts of Vitamins and Minerals 9. Single and Dual Column Labeling 10. The Footnote 11. Use of Highlighting With a Type Intermediate Between Bold or Extra Bold and Regular Type 12. Addition of Horizontal Line Beneath the Nutrition Facts Heading 13. Replacing ‘‘Total Carbohydrate’’ With ‘‘Total Carbs’’ 14. Alternative Visual Formats/Fonts N. Compliance 1. Level of Variance Allowed for the Label Declaration of Specific Nutrients 2. Methods Used To Determine Compliance 3. Records Requirements 4. Inclusion of Potassium as a Mineral 5. Requirements for Other Carbohydrate, Soluble and Insoluble Fiber, Added Sugars, and Sugar Alcohols O. Technical Amendments 1. Changing the Name of the Program Office 2. Changing the Publication Date of Report Incorporated by Reference 3. Plain Language Edits III. Proposed Effective and Compliance Dates IV. Analysis of Impacts V. Paperwork Reduction Act of 1995 VI. Analysis of Environmental Impact VII. Federalism VIII. Comments IX. References Executive Summary Purpose of the Regulatory Action FDA is proposing to amend the regulations for the nutrition labeling of conventional foods and dietary supplements to assist consumers in maintaining healthy dietary practices. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Following the passage of the Nutrition Labeling and Education Act (NLEA) of 1990 (the 1990 amendments) (Pub. L. 101–535), which added section 403(q) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)), we issued various regulations related to nutrition information on food labels, including the declaration of nutrients, the format for nutrition labeling, reference values for use in declaring the nutrient content, and allowances for certain specified products to be exempt from nutrition labeling (§ 101.9 (21 CFR 101.9)). In addition, following the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994 (Pub. L. 103–417 and 21 U.S.C. 321(ff)), we amended our food labeling regulations to establish requirements for nutrition labeling of dietary supplements (§§ 101.9(j)(6) and 101.36). Section 403(q) of the FD&C Act specifies certain nutrients to be declared in nutrition labeling, and authorizes the Secretary of Health and Human Services to require other nutrients to be declared if the Secretary determines that a nutrient will provide information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices. The Secretary also has discretion under section 403(q) of the FD&C Act to remove, by regulation and under certain circumstances, nutrient information that is otherwise explicitly required in food labeling under this section. We are proposing to revise our regulations to provide updated nutrition information on the label and improve how the nutrition information is presented to consumers, in light of current scientific evidence, dietary recommendations of most recent consensus reports, and public comments received in response to advance notices of proposed rulemaking. FDA invites comment on its use of the most recent consensus reports and whether the information and data on which FDA relies from such reports for proposed changes is consistent with current scientific information. Summary of the Major Provisions of the Regulatory Action in Question We discuss the need to update the Nutrition Facts and Supplement Facts labels in section I.B., and our scientific considerations for mandatory and voluntary declaration of nutrients are presented in section I.C. In sections II.A. through II.K., we discuss provisions related to the declaration, reference values, analytical methods, and definitions of nutrients that are required or permitted to be declared on the Nutrition Facts label of conventional PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 11881 foods, whereas corresponding changes to the Supplement Facts label of dietary supplements are presented in section II.L. We present our considerations related to the format of the Nutrition Facts and Supplement Facts labels in section II.M., and discuss issues related to compliance with the proposed requirements in section II.N. Some of the key proposed actions and considerations of the proposed rule are highlighted in this document. Among other amendments related to declaration of nutrients, we are proposing to remove the declaration of ‘‘Calories from fat’’ because current science supports a view that the type of fat is more relevant than overall total fat intake in increased risk of chronic diseases. In addition, removal of the ‘‘calories from fat’’ disclosure had no effect on consumers’ judgments of product healthfulness, accuracy in identifying nutrient contents of products, or perceptions in FDA’s consumer research. Considering current science and recommendations related to added sugars, we are also proposing to require the declaration of ‘‘added sugars,’’ that will provide consumers with information they need to implement the dietary recommendations of the Dietary Guidelines for Americans, 2010 (2010 DGA). We are also proposing to update the list of vitamins and minerals of public health significance. We currently require the mandatory declaration of percent Daily Values (DVs) of vitamins A and C, calcium and iron. We analyzed the nutrient inadequacy for vitamins and minerals based on biomarker data and total dietary intake (conventional foods and dietary supplements) using National Health and Nutrition Examination Survey (NHANES) data and other factors for mandatory and voluntary declaration discussed in section I.C. to determine which essential vitamins and minerals should be included as nutrients of public health significance. Based on this analysis, we are not proposing any changes to the current requirement for mandatory declaration of calcium and iron. In addition, we are proposing to require the declaration of vitamin D and potassium, and to permit, rather than require, the declaration of vitamins A and C. With respect to reference values used to declare percent DVs of nutrients, since 1993, new reports from the Institute of Medicine (IOM) and other consensus and policy reports (for example, the 2010 DGA and the Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for E:\FR\FM\03MRP2.SGM 03MRP2 11882 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules IOM’s report that set Dietary Reference Intakes (DRIs) for sodium, including a Tolerable Upper Intake Level of 2,300 mg/day (d) as a reference intake level not to exceed. A primary change that we are proposing to the format of the Nutrition Facts and Supplement Facts labels is to increase the prominence of the ‘‘Calories,’’ numeric value of calories, ‘‘Servings per container,’’ and numeric value of servings per container declarations. Research suggests that these proposed changes may increase consumers’ attention to the information, and in certain situations, help consumers to accurately identify the number of calories in a product. We are also proposing to move the ‘‘% DV’’ to the left side of the label in order to highlight the information for consumers. We are also proposing to remove the requirement for the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets. We intend to continue to perform consumer research during this rulemaking process to evaluate how variations in label format may affect consumer understanding and use of the Nutrition Facts label. We intend to publish the results of our research for public review and comment. We are also proposing to require the maintenance of records to support the declarations of certain nutrients under specified circumstances. Currently, there are no analytical methods that can distinguish between dietary fiber (soluble and insoluble fiber) and nondigestible carbohydrates that do not meet the definition of dietary fiber; added and naturally occurring sugars; the various forms of vitamin E; or folate and folic acid and there are no analytical methods that can determine the amount of added sugar in specific foods containing added sugars alone or in combination with naturally occurring sugars, where the added sugars are subject to fermentation. Therefore, for products that contain non-digestible carbohydrates that do not meet the definition of dietary fiber, more than one source of sugar, added sugars that undergo fermentation, various forms of vitamin E, or folate and folic acid, we are proposing that manufacturers must make and keep certain written records to verify their declarations of each of these nutrients in the labeling of the food associated with such records. We are also proposing that records must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce and VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.001</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Americans) have been published that update the quantitative intake recommendations of nutrients as well as their association with chronic disease and health-related conditions. We are using these new data to update, as appropriate, the reference values used in the declaration of percent DVs of nutrients on the Nutrition Facts and Supplement Facts labels. Among other amendments to reference values, we are proposing an updated reference value for the declaration of percent DV for sodium from the current value of 2,400 mg (milligrams) to 2,300 mg based on a consideration of current science and 11883 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules may be kept as original records, as true copies, or electronically, and manufacturers must provide those records to us for inspection and copying upon request during an inspection. We anticipate that consumer education efforts would be needed to help with consumer understanding and use of information presented under the changes to the Nutrition Facts and Supplement Facts labels proposed in this rule. We plan to use the results of our consumer research to help inform our future actions on this issue. Finally, we are proposing an effective date of 60 days after the date of the final rule’s publication in the Federal Register with a compliance date 2 years after the effective date. We invite comment on the proposed compliance date. In addition to the proposed compliance date, we invite comment on various other issues, as summarized in section XI. Costs and Benefits We have developed one comprehensive preliminary regulatory impact analysis that presents the benefits and costs of this proposed rule as well as the proposed rules entitled Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments taken together. The cumulative impact of these two nutrition labeling proposals, taken as a whole, is shown in the following table. SUMMARY OF COSTS AND BENEFITS [In billions of 2011 $] Benefits Present Value (PV): 3% ............................................................................................................................. 7% ............................................................................................................................. Annualized (3% PV Amount) 3% ............................................................................................................................. Annualized (7% PV Amount) 7% ............................................................................................................................. Costs Net benefits $31.4 21.1 $2.3 2.3 $29.1 18.8 2.0 0.2 1.8 1.9 0.2 1.7 Notes: Compliance period is 24 months. Costs include relabeling and reformulation costs, which are one-time costs, as well as recordkeeping costs, which recur. Present values of relabeling and reformulation costs are equivalent at 3 or 7 percent because we conservatively assume that these one-time costs are incurred upon publication of the rule instead of at the end of the compliance period. Recordkeeping costs, because of their recurring nature, differ by discount rate; however, such costs comprise a very small percentage of total costs. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 I. Background The 1990 amendments added section 403(q) to the FD&C Act, which specifies, in part and with certain exceptions, that food is deemed misbranded unless its label or labeling bears nutrition information for certain nutrients. To implement the 1990 amendments, on January 6, 1993, FDA issued several rules, including ‘‘Food Labeling: Mandatory Status of Nutrition Labeling and Nutrient Content Revision, Format for Nutrition Label (the 1993 nutrient content final rule)’’; ‘‘Food Labeling; Reference Daily Intakes and Daily Reference Values (1993 RDI/DRV final rule)’’; and ‘‘Food Labeling: Serving Sizes’’, to modify how nutrition information is presented on food labels (58 FR 2079; 58 FR 2206; 58 FR 2229, respectively). FDA published regulations related to: (1) Declaration of nutrients on food labeling, including nutrients that are required or permitted to be declared and the format for such declaration; (2) label reference values for use in declaring the nutrient content of a food on its label or labeling; (3) two types of reference values, Reference Daily Intakes (RDIs) for vitamins and minerals and Daily Reference Values (DRVs) for certain nutrients, which are used to declare nutrient contents as percent DVs on the Nutrition Facts label; (4) exemptions for certain specified products; and (5) a simplified VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 form of nutrition labeling and the circumstances in which such simplified nutrition labeling can be used. (See § 101.9.) Elsewhere in this issue of the Federal Register, we are publishing a proposed rule that will amend the definition of a single-serving container, require dual column labeling for certain containers, update the reference amounts customarily consumed and serving sizes for several food product categories and amend the serving size for breath mints. In 1994, DSHEA became law. Among other things, DSHEA amended section 403(q)(5)(F) of the FD&C Act by adding specific requirements that relate to the labeling of dietary supplement products. Accordingly, we amended our food labeling regulations to establish requirements for nutrition labeling of dietary supplements (§§ 101.9(j)(6) and 101.36). The regulatory history, our rationale for existing requirements, and FDA activities related to nutrition labeling of foods and dietary supplements are described in Reference 1. A. Legal Authority We are proposing to update the Nutrition Facts label and Supplement Facts label, as set forth in this proposed rule, consistent with our authority in section 403(q) of the FD&C Act. Section 403(q)(1) of the FD&C Act states that a food shall be deemed to be misbranded PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 if, with certain exceptions, it fails to bear nutrition labeling and identifies specific nutrient and calorie information required in labeling. Section 403(q)(2)(A) of the FD&C Act provides the Secretary, and by delegation, FDA, with discretion to require by regulation nutrition information about nutrients other than those specified in section 403(q)(1) of the FD&C Act to assist consumers in maintaining healthy dietary practices. Section 403(q)(2)(B) of the FD&C Act permits the Secretary, and by delegation, FDA, to remove information relating to a nutrient required by section 403(q)(1) or 403(q)(2)(A) of the FD&C Act if the Secretary determines that it is not necessary to assist consumers in maintaining healthy dietary practices. Consistent with these authorities, we are proposing to revise certain nutrient declarations in the Nutrition Facts label and Supplement Facts label. In addition, FDA’s authority includes section 2(b)(1) of the 1990 amendments (21 U.S.C. 343 note). Specifically, section 2(b)(1)(A) of the 1990 amendments requires nutrition label information be conveyed in a manner that enables the public to readily observe and comprehend the information and to understand its relative significance in the context of a total daily diet. Such section states that such information should be consistent E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11884 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules with current scientific knowledge about nutrients and health. We are proposing changes to DVs (RDIs and DRVs, as applicable) for some nutrients, which values are used to calculate the percent DV for use on food labels. The use of reference values based on current science and the use of such values to calculate the percent DV assists consumers in comprehending the nutrition information and its relative significance in a total daily diet. We are also proposing changes to the format pertaining to information on the percent DV value. Further, section 2(b)(1)(C) of the 1990 amendments stipulates that regulations ‘‘shall permit the label or labeling of food to include nutrition information which is in addition to the information required by such section 403(q) [of the FD&C Act] and which is of the type described in subparagraph (1)(or (2) of such section . . . .’’ We are proposing changes to the voluntary declaration of certain nutrients in the Nutrition Facts label consistent with such authority. Other relevant authorities include sections 701(a), 403(a)(1) and 201(n) of the FD&C Act (21 U.S.C. 371(a), 21 U.S.C. 343(a)(1), and 21 U.S.C. 321(n), respectively). Under section 701(a) of the FD&C Act, the Agency may issue regulations for the efficient enforcement of the FD&C Act in order to ‘‘effectuate a congressional objective expressed elsewhere in the Act’’ (Association of American Physicians and Surgeons, Inc. v FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm. Mfrs. Ass’n. v FDA, 484 F. Sup. 1179, 1183 (D. Del. 1980).) We are relying on our authority under sections 403(q), 403(a), 201(n) and 701(a) of the FD&C Act, to propose record requirements to support nutrient declarations in labeling for added sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin E, and folate/ folic acid, under certain circumstances, so that we can determine compliance with labeling requirements and take enforcement action, as needed. For these nutrients, as explained in section II.N., there is no AOAC official method of analysis of AOAC International or other reliable or appropriate analytical procedure, otherwise required by § 101.9(g), available for FDA to quantify the declared amount of the nutrient, under certain circumstances. Section 101.9(g) sets forth the standards for accuracy of the amount statements of nutrients on food labels. Failing to accurately state the amounts of nutrients on the label under § 101.9(g) would result in a product being misbranded. Under section 403(q) of the FD&C Act, a food must bear, in its label or labeling, the amount of the nutrient the food VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 contains. Moreover, the nutrient declaration must be truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&C Act. Thus, when a food product contains dietary fiber (whether soluble, insoluble, or a combination of both) and added nondigestible carbohydrate(s) that does not meet the definition of dietary fiber, we are proposing to require manufacturers to make and keep certain written records to verify the amount of added non-digestible carbohydrate that does not meet the definition of dietary. When vitamin E is present in a food as a mixture of all rac-a-tocopherol acetate and RRR-a-tocopherol, we are proposing to require manufacturers to make and keep written records to verify the amount of all rac-a-tocopherol acetate added to the food and RRR-a-tocopherol in the finished food. When a mixture of folate and folic acid is present in a food, we are proposing to require manufacturers to make and keep records to verify the amount of folic acid added to the food and folate in the finished food. When added sugars as well as naturally occurring sugars are present in a food, we are proposing to require manufacturers to make and keep records to verify the declared amount of added sugars in the food. Finally, we are proposing to require manufacturers to make and keep records to verify the declared amount of added sugars in specific foods, alone or in combination with naturally occurring sugars, where the added sugars are subject to fermentation. The proposed record requirements for these nutrients, under the circumstances described, are designed to ensure that the nutrient declarations are accurate, truthful and not misleading, based on information known only to the manufacturer, and to facilitate efficient and effective action to enforce the requirements when necessary. Our authority to establish records requirements has been upheld under other provisions of the FD&C Act where FDA has found such records to be necessary (National Confectioners Assoc. v Califano, 569 F.2d 690, 693–94 (D.C. Cir. 1978). The records we propose to require are only for foods for which an adequate analytical method is not available. The records would allow us to verify the declared amount of each of these nutrients and that such amount is truthful and not misleading. Thus, the proposed records requirements would help in the efficient enforcement of the FD&C Act. The authority granted to FDA under sections 701(a), 403(q), 403(a)(1) and 201(n) of the FD&C Act not only includes authority to establish records PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 requirements, but also includes access to such records. Without such authority, the nutrient declarations for these specific nutrients that FDA has determined are necessary to assist consumers in maintaining healthy dietary practices under section 403(q)(2)(A) of the FD&C Act are, practically speaking, not enforceable. Without access to such records, FDA would not know whether the amount declared on the label or in the labeling of each these nutrients, under the circumstances described, is truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&C Act. The introduction or delivery for introduction into interstate commerce of a misbranded food is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. 331(a)). Thus, to determine whether the food is misbranded and the manufacturer has committed a prohibited act, we must have access to the manufacturer’s records that we are requiring be made and kept under sections 403(q), 403(a)(1), 201(n) and 701(a) of the FD&C Act. Failure to make and keep records and provide the records to FDA, as described in proposed § 101.9(g)(10) and (g)(11), would result in the food being misbranded under sections 403(q) and 403(a)(1) of the FD&C Act. B. Need To Update the Nutrition Facts and Supplement Facts Labels FDA first issued regulations related to the Nutrition Facts label in 1993. We have not updated the Nutrition Facts label since the 2003 trans fat rulemaking (68 FR 41434; July 11, 2003) or established new or updated DVs for nutrients since 1995 (60 FR 67164; December 28, 1995). Since that time, the public health profile of the U.S. population has changed (e.g., increase in obesity), new information has become available about nutrient definitions (e.g., vitamin E), reference intake values, and analytical methods, and new dietary recommendations (see section I.B.2.) have been published. As a result, we are reconsidering what nutrients we should require or permit to be listed on the Nutrition Facts label and what nutrient reference intake values we should use as a basis for calculating the percent DVs in food labeling. We also considered corresponding changes to the Supplement Facts labels. We discuss specific nutrient declarations in greater detail in section II. Section I.B. includes an overview of information we considered when forming our tentative conclusions, including scientific and technical data and recommendations, citizen petitions submitted to us, and public comments to previous requests E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 for comment in advance notices of proposed rulemaking on topics related to this proposed rule. We also considered the role of nutrition labeling to assist consumers in maintaining healthy dietary practices and consumers’ use and understanding of the Nutrition Facts label. 1. Rates of Chronic Disease Chronic diseases, such as heart disease, cancer and stroke are the leading causes of death and disability in the United States, and account for 70 percent of all deaths in the United States (Ref. 2). In 2005, 133 million Americans, almost one out of every two adults, had at least one chronic illness (Ref. 2). An estimated 37 percent of Americans suffer from cardiovascular disease (CVD) (Ref. 3), 11.3 percent of the population 20 years and older has diabetes, 35 percent of adults has prediabetes (Ref. 4), and 41 percent of the population is predicted to be diagnosed with cancer during their lifetime (Ref. 5). While the causes of these chronic diseases are multifactorial, poor diet is a contributing factor associated with morbidity and mortality (Ref. 6). Many nutrients are associated with chronic disease risk. For example, diets low in saturated fat and cholesterol, and/or sodium are associated with a decreased risk of CVD (58 FR 2739; January 6, 1993, and 58 FR 2820; January 6, 1993). Adequate or increased intake of calcium and vitamin D may decrease the risk of osteoporosis (73 FR 56477; September 29, 2008). Obesity rates have increased dramatically over the last three decades. Between 1976 and 1980 and 2007 and 2008, obesity rates increased more than twofold (from 15 to 34 percent) in adults and more than threefold (from 5 to 17 percent) among children and adolescents (Refs. 6 to 8). Data published by the U.S. Centers for Disease Control and Prevention (CDC) indicate that 68 percent of adults and about 32 percent of children aged 2 to 19 years in the U.S. population are overweight or obese (Refs. 7 and 8). Excessive body weight is a risk factor for chronic diseases such as heart disease, some forms of cancer, and type II diabetes (Ref. 9). The 2010 DGA affirmed the role of over consumption of calories and physical inactivity as the primary risk factors contributing to an epidemic of overweight and obesity in this country, and urged for a focus on improved nutrition and physical activity choices among Americans (Ref. 6). Elevated blood pressure, an important risk factor for CVD (Ref. 10), affects about one-third of the U.S. adult VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 population (Ref. 2). High intakes of sodium are directly associated with elevated blood pressure (Ref. 10). Average sodium intake for the U.S. population 4 years of age and older is approximately 3,650 mg/d (Ref. 11). Almost all Americans consume more sodium than the levels recommended by the 2010 DGA (Ref. 12) Furthermore, while concerns in recent years have largely shifted away from nutritional deficiencies, some population subgroups may consume excess calories but still consume inadequate amounts of certain micronutrients such as iron, vitamin D, calcium and potassium (see section II.H.). The mandatory declaration of nutrients that have public health significance, the use of updated DVs based on current scientific evidence, and the use of a format for the Nutrition Facts label to assist with consumer use and understanding can help consumers make informed food choices to consume a nutritionally adequate diet while monitoring calorie intake and lowering their risk of some chronic diseases. 2. Dietary Recommendations, Consensus Reports, and National Survey Data a. IOM Dietary Reference Intakes Reports (IOM DRI Reports)—In 1994, the Food and Nutrition Board (FNB) of the Institute of Medicine (IOM) identified principles for the development of a new set of reference values that could expand and replace the IOM’s Recommended Dietary Allowances (RDAs) of 1989 (Refs. 13 and 14). A comprehensive review and application of a growing body of nutritional science research resulted in the development of a set of reference values, collectively known as DRIs, published from 1997 to 2010 (Ref. 15). The DRIs represent a shift in the way that reference values are established or intended for use. In contrast to previous editions of RDAs (e.g., the 1968 and 1989 RDAs), which involved establishing single values for each nutrient with appropriate adjustments for age, sex and physiological status, the new DRI framework consisted of four categories of reference values. These categories include the Estimated Average Requirement (EAR), RDA, Adequate Intake (AI) and Tolerable Upper Intake Level (UL). For macronutrients—carbohydrates, fats, and protein—the IOM developed a new set of reference values called the Acceptable Macronutrient Distribution Ranges (AMDRs). The EAR is the average daily nutrient intake level that is estimated to meet the requirements of half of the healthy PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 11885 individuals in a particular life stage and gender group. EARs are used for assessing the statistical probability of adequacy of nutrient intakes of groups of people. The RDA is an estimate of the average intake level that meets the nutrient requirements of nearly all (97 to 98 percent) healthy individuals in a particular life stage and gender group. The RDA is set using the EAR. In general, the RDA is the EAR plus two times the standard deviation of the EAR. The RDA is used to plan nutrient intakes for individuals to ensure a low probability of inadequacy. Nutrients with EARs and RDAs include carbohydrate, protein, vitamin A, vitamin C, vitamin E, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, copper, iodine, iron, magnesium, phosphorus, selenium, zinc, calcium and vitamin D. An AI is the level determined for an essential nutrient or a nutrient that is beneficial for human health when there is insufficient evidence to calculate an EAR for that nutrient, and therefore insufficient evidence on which to establish an RDA. AIs can be based on a variety of data, including scientific evidence about the essentiality of a nutrient (i.e., choline, biotin, fluoride), experimental data on risk reduction of chronic disease (i.e., dietary fiber, potassium), and median intakes of a nutrient using national survey data (i.e., vitamin K, pantothenic acid, chromium, manganese, linoleic acid, and [alpha]linolenic acid). Although there is less certainty about an AI value than about an RDA value, the AI is similarly designed to cover the needs of nearly all individuals. The IOM Dietary Planning Report and Dietary Assessment Report noted that ‘‘the AI should be used with less confidence if it has not been established as the mean intake of a healthy group.’’ The UL is the highest average daily intake level likely to pose no risk of adverse health effects for nearly all people in a particular group. The UL is not intended to be a recommended level of intake. The UL is used to assess the risk of adverse health effects from excessive nutrient intake. As intake above the UL increases, so does the potential for risk of adverse health effects. Nutrients with ULs include vitamin A, vitamin C, vitamin D, vitamin E, niacin, vitamin B6, folate, choline, calcium, copper, fluoride, iodine, iron, magnesium, manganese, molybdenum, phosphorus, selenium, zinc, sodium, and chloride. Moreover, while the previous RDAs primarily focused on reducing the incidence of diseases of nutrient deficiency in the population, the DRIs E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11886 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules now take into consideration data on chronic disease risk, such as heart disease, and developmental abnormalities, such as teratogenicity, rather than only the signs of deficiency. Finally, where sufficient data exist, the DRIs take into account the potential benefit or risk to health of substances that are not essential (such as dietary fiber and fluoride) that are in addition to the macronutrients of total carbohydrate, protein, and fat, and the micronutrient vitamins and minerals permitted or required on the Nutrition Facts label (Ref. 15). Beginning in 1997, the IOM began publishing its DRIs for those vitamins, minerals, and macronutrients that are essential in humans or provide a beneficial role in human health (Refs. 16 to 22). In addition, the IOM also set AMDRs for carbohydrates, fat, and protein (Ref. 23). The AMDR for a macronutrient is based on the amount of the macronutrient that is associated with a reduced risk of chronic disease while providing adequate intakes of essential nutrients. The AMDR is expressed as a range of percent energy intake (e.g., 20 to 35 percent of calories from total fat for adults over 18 years of age). The DRIs and AMDRs were set for the following life stage groups: Infants (0 to 6 and 7 to 12 months); toddlers (1 to 3 years); boys and girls (4 to 8 years); adolescent boys and girls (9 to 13 and 14 to 18 years); adult men and women (19 to 30, 31 to 50, 51 to 70, and greater than 70 years); and pregnant and lactating women. b. IOM Dietary Fiber Report—In 2001, the IOM Panel on the Definition of Dietary Fiber (the IOM Dietary Fiber Panel) responded to our request to provide definitions for dietary fiber based on its role in human physiology and health. The IOM Dietary Fiber Panel developed two categories of definitions of fiber: ‘‘Dietary Fiber’’ and ‘‘Added Fiber’’ in its report Dietary Reference Intakes: Proposed Definition of Dietary Fiber (the IOM Dietary Fiber Report) (Ref. 24). c. IOM Dietary Assessment Report—In 2000, the IOM Subcommittee on Interpretation and Uses of Dietary Reference Intakes (IOM uses Committee) published the report, DRIs Application in Dietary Assessment (IOM Dietary Assessment report) on how to use the DRIs for dietary assessment of individuals and groups. d. IOM Labeling Report—In 2003, the IOM Committee on nutrition labeling (IOM Labeling Committee) considered how the DRIs can be used to develop appropriate reference values for nutrition labeling and published its report, co-funded by FDA, DRI Guiding VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Principles for Nutrition Labeling and Fortification (the IOM Labeling Report) (Ref. 25), with the goal of having an updated nutrition label that consumers can use to make informed dietary choices. e. IOM Dietary Planning Report—In 2003, the IOM Subcommittee on interpretation and uses of DRIs (IOM Uses Committee) published a report, DRIs Application in Dietary Planning (IOM Dietary Planning Report) (Ref. 26) on how to use the DRIs for planning intakes of individuals and groups. This report discusses the use of the DRIs for food and supplement labels. f. IOM Sodium Strategies Report—In 2008, the IOM convened a Committee on Strategies to Reduce Sodium Intake in the United States to address a Congressional request for recommendations about various means that could be employed to reduce dietary sodium intake to levels recommended by the 2005 DGA (less than 2,300 mg/d and no more than 1,500 mg/d for African-Americans, people with hypertension, and middle-aged and older adults). The Committee’s report, Strategies to Reduce Sodium Intake in the United States (IOM Sodium Strategies Report), published in 2010, among other strategies, discusses how the labeling of sodium on foods can serve as a supporting strategy for reducing sodium intake (Ref. 27). g. IOM Front-Of-Package Nutrition Rating Systems and Symbols Phase I and Phase II Reports—In 2010, the IOM Committee on Front-of-Package (FOP) Nutrition Rating Systems and Symbols reviewed the existing FOP systems and their underlying nutrition criteria. In the Phase I report, the IOM identified the nutrients for which there was sufficient evidence of their role in chronic disease risk and which should be included in a FOP label (Ref. 28). In 2012, the IOM published its phase II report that recommended developing a single standardized FOP rating system and updated their recommendations for nutrients to be included on the FOP label (Ref. 29). h. IOM Sodium Intake in Populations Report—In 2012 the IOM convened a Committee to review and assess the benefits and adverse outcomes (if any) of reducing the sodium intake in the population, particularly in the range of 1,500 to 2,300 mg/d. The Committee was also asked to specifically emphasize relevant subgroups in the analysis including those 50 years of age and older, African Americans, and those with diabetes, chronic kidney disease, and congestive heart failure. The Report was published in May of 2013 and focused its findings and conclusions on PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 evidence for associations between sodium intake and the risk of CVDrelated events and mortality. i. Dietary Guidelines for Americans (DGA), 2010—The 2010 DGA, developed jointly by the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS), provide several key recommendations including recommendations about dietary patterns, as well as quantitative intake recommendations with respect to micronutrients and macronutrients, most of which are based on the IOM DRI reports (Ref. 6). In a few cases, the 2010 DGA provided quantitative intake recommendations for certain nutrients (i.e., cholesterol and saturated fat) that were not provided by the IOM DRI reports (Ref. 6). The 2010 DGA emphasized the importance of meeting food and nutrient recommendations while balancing calorie needs (Ref. 6). More information regarding the scientific basis that informed the development of the 2010 DGA can be found in the Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010 (2010 DGAC) (Ref. 30). An important note related to the 2010 DGA is the specified intended audience for its recommendations (Ref. 6). From the 1980s until 1995, the DGAs were targeted toward healthy Americans and designed to provide advice to healthy individuals about food choices that promote health and prevent disease (Refs. 31 to 34). In 2000, the recommendations specified an audience of ‘‘healthy children ages 2 years and older and adults of any age,’’ and the 2005 DGA provided recommendations for the ‘‘general public age 2 years and older.’’ (Refs. 35 and 36). While the DGAs have always taken into account the needs of subpopulations, the most recent 2010 DGA goes beyond the traditional target of a ‘‘healthy’’ audience to provide chronic disease,’’ noting ‘‘the reality that a large percentage of Americans are overweight or obese and/or at risk of various chronic diseases’’ (Ref. 6). j. National Health and Nutrition Examination Survey (NHANES)—The NHANES provides the primary source of information on the health and nutritional status of adults and children in the United States. The survey examines a nationally representative sample of about 5,000 persons each year. These persons are located in counties across the country. The survey combines interviews, which include demographic, socioeconomic, dietary, and health-related questions, and physical examinations, which consist of E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 medical, dental, and physiological measurements, as well as laboratory tests administered by highly trained medical personnel (Ref. 37). 3. Consumer Use and Understanding of the Nutrition Facts Label The Nutrition Facts label is intended to help consumers make informed food choices and maintain healthy dietary practices. Consumers became increasingly aware of the new label in the years following implementation of the 1990 amendments, and reported using food labels more often in their purchasing decisions compared to their use before the introduction of the Nutrition Facts label (Ref. 38). Data from a nationally representative sample of U.S. adults collected through FDA’s Health and Diet Surveys suggest that the frequency of food label use among consumers progressively increased between 2002 and 2008 (Refs. 39 to 41). For example, the percentage of consumers reporting that they ‘‘often’’ read a food label the first time they purchase a food product rose from 44 percent in 2002 to 54 percent in 2008. Among those indicating they read food labels when purchasing a product for the first time, two-thirds of them in 2008 reported using the label to see how high or low the food was in calories, salt, vitamins or fat, while more than half said they used labels to get a general idea of the nutritional content of the product. A similar increase in reported use of food labels has also been shown using data from the National Health and Nutrition Examination Surveys 2007–2008 and 2009–1010. The percent of working age adults that reported using the Nutrition Facts Panel (NFP) always or most of the time when shopping for food increased to 42% in 2009–2010 from 34% in 2007–2008. Among older adults the percentage increased to 57% in 2009–2010 from 51% in 2007–2008. (Ref. 42). Consumer research data suggest that, despite the widespread use of food labels, certain elements of the Nutrition Facts label may need improvement. For example, some consumers have difficulty understanding the concept of percent DV (Refs. 43 and 44) or are confused by the label footnote that lists DVs for certain nutrients based on a 2,000 and 2,500 calorie diet (Ref. 45). Section 2(b)(1)(A) of the 1990 amendments mandated that FDA regulations implementing section 403(q) of the FD&C Act require that nutrition labeling must be conveyed to the public in a manner which enables the public to readily observe and comprehend such information and to understand its relative significance in the context of a VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 total daily diet. In particular, the percent DV of a nutrient present in food is declared on food labels to help consumers understand the relative significance of nutrition information in the context of a total daily diet, compare the nutritional values of food products, and to plan general diets (58 FR 2206 at 2213; January 6, 1993). We also noted that the percent DV information advises the consumer how much of a recommended intake of that nutrient is provided by the food (58 FR 2079 at 2123; January 6, 1993). We developed the term ‘‘Daily Value’’ to refer to all reference values on the nutrition label (DRVs and RDIs). We noted that some of the reference values were intended to guide consumers relative to maximum intakes (DRVs) (e.g., saturated fat), while others were intended to serve as the basis for planning general diets to meet nutrient requirements (RDIs) (e.g., vitamin C) (58 FR 2079 at 2124). Our research at the time showed that the term ‘‘Daily Value’’ was generally understood by consumers as a point of reference (58 FR 2079 at 2125). In order to determine a nutrition labeling format that could be used most effectively by consumers, we conducted consumer research and evaluated research conducted by others in considering requirements for the nutrition label format (58 FR 2079 at 2115–2121). When available, we used empirical data on how consumers use and understand the label in proposing what information should be declared on the label and how. We used focus group data to inform what we would test in experimental studies, but did not rely on such data to make policy decisions. Several comments to the ANPRMs submitted focus group data. However, we are not relying on focus group data for the proposed changes to the Nutrition Facts label because focus groups do not yield meaningful quantitative findings and are not able to support conclusions about the relationships between the presentation of label information and consumer responses. As such, they cannot be used to drive the development of policies, programs, and services. Policy makers and educators can use focus groups findings to test and refine their ideas, but should then conduct further research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies. We have completed one study that examined dual-column labels and ways to increase prominence of certain label information, and intend to continue to perform research during this rulemaking process to evaluate how variations in PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 11887 label format may affect consumer understanding and use of the Nutrition Facts label. Issues to be addressed include how a declaration of ‘‘Added Sugars’’ and alternative footnote statement may influence consumer use of the label. The overall goal of these studies is to assess a consumer’s ability to use the Nutrition Facts label and assess a consumer’s preferences related to proposed modifications of the Nutrition Facts label format. In addition, the studies will help us focus our efforts on consumer education as well as enhance our understanding of whether modifications to the Nutrition Facts label format could help consumers make more informed choices based on their perceptions of the nutritional attributes and overall healthfulness of a food product. (See also discussion in section II.M.) 4. Other Relevant Considerations In developing this proposed rule, we considered changes that would assist consumers in maintaining healthy dietary practices and recognize that it is important for the updated Nutrition Facts label to be useful and relevant to the American population. While the Nutrition Facts label information has never been nor is it now targeted to individuals with acute or chronic disease, we are considering the large portion of the U.S. population that is at risk for chronic disease in proposing changes to the label’s content and format. The population at risk for chronic disease includes those who are overweight, and therefore at increased risk of certain chronic diseases, or those who are obese, leading to a variety of complications including diabetes and CVD. This approach is consistent with the new IOM DRIs, which are for healthy individuals, including those atrisk of disease, but not for individuals with acute or chronic disease or nutrient deficiencies (Ref. 15). Similarly, the DGAs are for Americans ages 2 years and older, including those at risk of chronic disease. While consumers with acute or chronic disease, such as obesity, CVD, or diabetes, may be able to use quantitative information on the label to follow advice they have received from a health care professional concerning their conditions, the nutrient declarations and percent DVs on the label are to help consumers make more informed choices to consume a healthy diet and not intended for the clinical management of an existing disease. In addition, we recognize the importance of federal regulations reflecting the most current science. In developing this proposed rule, we E:\FR\FM\03MRP2.SGM 03MRP2 11888 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 considered new scientific evidence and dietary recommendations about the relationship between nutrients and health. Finally, we recognize that the goal of assisting consumers in maintaining healthy dietary practices requires that we consider certain practicalities. For example, as we noted in the 1993 nutrient content final rule (58 FR 2079 at 2107), while the 1990 amendments permit the Secretary of Health and Human Services to include in the Nutrition Facts label any information about a nutrient that will assist consumers in maintaining healthy dietary practices, there is not room on the label for all information that may be related to maintaining healthy dietary practices. Space constraints on the label of most foods make declaring all essential nutrients impractical. In addition, having a large amount of information on the label could interfere with consumers’ abilities to use the information that has the greatest public health significance. Therefore, not only are we aware of the amount and format of mandatory information on the label, but we recognize that limits to the voluntary information are necessary, so that voluntary information does not clutter the label, does not mislead, confuse, or overwhelm the consumer, and does not take away prominence of and emphasis on the required information. 5. Citizen Petitions Since 1993, we received a number of citizen petitions requesting that FDA make various changes to the Nutrition and Supplement Facts labels. We are addressing a number of issues raised in the following petitions within this proposed rule: (1) The Calorie Control Council submitted a citizen petition on April 13, 1995 (Docket No. FDA–1995– P–0142) requesting that FDA permit the use of the term ‘‘polyols’’ in lieu of sugar alcohols on the Nutrition Facts label (https://www.regulations.gov/ #!docketDetail;D=FDA-1995-P-0142); (2) the American Cocoa Research Institute submitted a citizen petition on April 4, 1996 (Docket No. FDA–1996–P–0035) recommending the accurate communication of the scientific fact that stearic acid does not affect blood cholesterol (https://www.regulations.gov/ #!docketDetail;D=FDA-1996-P-0035); (3) Nabisco, Inc. submitted a citizen petition on May 8, 1997 (Docket No. FDA–1997–P–0476) requesting that FDA amend the definition of ‘‘total fat’’ and ‘‘saturated fat’’ in its food labeling regulations to clarify that acetic, propionic, and butyric acids may be excluded when calculating the amount VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 of fat in a food product (https:// www.regulations.gov/ #!docketDetail;D=FDA-1997-P-0476); (4) the Calorie Control Council submitted a citizen petition on February 13, 1998 (Docket No. FDA–1997–P–0232) requesting that the caloric value of soluble fiber be no more than 2 kcal/g (https://www.regulations.gov/ #!docketDetail;D=FDA-1997-P-0232); (5) the Center for Science in the Public Interest (CSPI) submitted a citizen petition on August 4, 1999 (Docket No. FDA–1999–P–0158) requesting that FDA establish a DV for added sugars and require the amount of added sugar, and the percent DV that represents, to be declared on food labels (https:// www.regulations.gov/ #!docketDetail;D=FDA-1999-P-0158); (6) Protein Technologies International, Inc. submitted a citizen petition on December 21, 2000 (FDA–2000–P–0569) requesting that FDA modify the reference to the method used to calculate protein content (https:// www.regulations.gov/ #!docketDetail;D=FDA-2000-P-0569); (7) the National Starch and Chemical Company (‘‘National Starch’’) submitted a citizen petition on July 8, 2004 (Docket No. FDA–2004–P–0094) requesting that dietary fiber content be excluded from the ‘‘total carbohydrate’’ declaration on the Nutrition Facts label (https://www.regulations.gov/ #!docketDetail;D=FDA-2004-P-0094); (8) the Sugar Association submitted a citizen petition on August 15, 2005 (Docket No. FDA–2005–P–0373) requesting, in part, that FDA amend regulations related to the labeling of sugar and alternative sweeteners (https:// www.regulations.gov/ #!docketDetail;D=FDA-2005-P-0373); (9) CSPI submitted a citizen petition on November 8, 2005 (Docket No. FDA– 2005–P–0196) requesting, in part, that FDA lower the DV for sodium from 2,400 to 1,500 mg/day (https:// www.regulations.gov/ #!docketDetail;D=FDA-2005-P-0196); (10) an individual submitted a citizen petition on May 25, 2005 (Docket No. FDA–2005–P–0126) requesting that FDA preclude the declaration of b-carotene in supplements as vitamin A (https:// www.regulations.gov/ #!docketDetail;D=FDA-2005-P-0126); (11) an individual submitted a citizen petition on January 17, 2007 (Docket No. FDA–2007–P–0404) requesting that FDA amend the definition of trans fat in its food labeling regulations to express the value of ‘‘zero’’ for trans fat when there are ‘‘absolutely no trans fats at all’’ and require the use of a symbol (e.g., ‘‘∼’’) to indicate when there is ‘‘more than zero PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 but less than 0.5 grams (g) of trans fat per tablespoon’’ (https:// www.regulations.gov/ #!docketDetail;D=FDA-2007-P-0404); and (12) CSPI submitted a citizen petition on February 13, 2013 (Docket No. FDA–2013–P–0217) requesting, in part, that FDA revise the ‘‘Sugars’’ line on the Nutrition Facts label to address ‘‘added sugars’’ (https:// www.regulations.gov/ #!docketDetail;D=FDA-2013-P-0217). We address the specific requests identified previously for each citizen petition related to the labeling of conventional foods and dietary supplements in the appropriate sections in this document. Requests in these citizen petitions that are unrelated to the content of the Nutrition Facts label are outside of the scope of this rulemaking and we will address those requests separately from this rulemaking. 6. Advance Notices of Proposed Rulemaking (ANPRMs) We also published three ANPRMs seeking public comment on issues relevant to updating the Nutrition Facts label. a. ANPRM on Trans Fat—In the Federal Register of July 11, 2003 (68 FR 41507), we published an ANPRM (the 2003 ANPRM) to solicit information and data that potentially could be used to establish new nutrient content claims about trans fatty acids; to establish qualifying criteria for trans fat in nutrient content claims for saturated fatty acids and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterolraising lipids; and, in addition, to establish disclosure and disqualifying criteria to help consumers make hearthealthy food choices. We also requested comments on whether we should consider statements about trans fat, either alone or in combination with saturated fat and cholesterol, as a footnote in the Nutrition Facts label or as a disclosure statement in conjunction with claims to enhance consumer understanding about cholesterol-raising lipids and how to use the information to make healthy food choices. On March 1, 2004 (69 FR 9559), we reopened the comment period for the 2003 ANPRM to receive comments that considered the information in the IOM Labeling Report (Ref. 25) published in the interim that addressed the labeling of trans fat. On April 19, 2004 (69 FR 20838), we extended the comment period for the 2003 ANPRM to receive comments that considered the information in the 2004 meeting of the Nutrition Subcommittee of the Food Advisory Committee (Ref. E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 46), which addressed whether the available scientific evidence supported listing the percent DV for saturated fat and trans fat together or separately on the Nutrition Facts label and what the maximal daily intake of trans fat may be. In response to the 2003 ANPRM, we received about 120 comments. We consider the comments related to determining a DV for trans fat in section II.B.3. (see also accompanying Ref. 47). Other issues raised by comments that are unrelated to the DV for trans fat will be addressed in a separate rulemaking at a future time. b. ANPRM on Prominence of Calories—In the Federal Register of April 4, 2005 (70 FR 17008), we published an ANPRM on the prominence of calories on the food label (the 2005 ANPRM). The 2005 ANPRM was issued in response to recommendations from the Obesity Working Group created by the Commissioner of Food and Drugs to develop an action plan to address the growing incidence of obesity in the United States. The 2005 ANPRM, in part, requested comments on whether giving more prominence to the declaration of calories per serving would increase consumer awareness of the caloric content of the packaged food. We also sought comment on whether providing a percent DV for total calories would help consumers understand the caloric content of the packaged food in the context of a 2,000 calorie diet. In addition, we also requested comments on questions concerning the declaration of ‘‘Calories from fat’’ (70 FR 17008 at 17010). We received about 400 comments to the 2005 ANPRM, each containing one or more issues, from industry, trade associations, consumer groups, individual consumers, government, and academia. We consider the comments in sections II.A. and II.M. (see also accompanying Ref. 47). c. ANPRM on Food Labeling: Revision of Reference Values and Mandatory Nutrients—In the Federal Register of November 2, 2007 (72 FR 62149), we published an ANPRM regarding the revision of reference values and mandatory nutrients (the 2007 ANPRM). The 2007 ANPRM requested comment on various aspects of nutrition labeling, including what new reference values we should use to calculate the percent DV in the Nutrition Facts and Supplement Facts labels and what factors we should consider in establishing such new reference values. In addition, we requested comments on whether we should require that certain nutrients be VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 added or removed from the Nutrition Facts and Supplement Facts labels. In response to the 2007 ANPRM, we received about 820 comments, from industry, trade associations, consumer groups, individual consumers, government, and academia. We consider these comments in each of the relevant individual nutrient sections in this document (see also accompanying Ref. 47). 7. Impact on Other Regulations We recognize that changes to the list of nutrients declared on the Nutrition Facts label or the RDIs or DRVs of nutrients will likely affect other FDA regulations, including certain labeling requirements for foods in 21 CFR part 101. For example, the DVs are used to determine, in part, whether a food or dietary supplement is eligible to bear nutrient content claims or health claims (see for example §§ 101.14, 101.54, 101.76, 101.78, and 101.79). In addition, our fortification policy refers to RDIs and certain DRVs that are specified in § 101.9 in describing principles for the rational addition of nutrients to foods (§ 104.20 (21 CFR 104.20)). We plan to evaluate the impact of the proposed changes to the Nutrition Facts and Supplement Facts labels, if finalized, on other FDA regulations. We intend to address, as appropriate, the impact on other FDA regulations in future separate rulemakings. Thus, issues related to nutrient content claims and health claims are outside the scope of this rulemaking. C. Factors for Mandatory or Voluntary Declaration of Non-Statutory Nutrients Under section 403(q)(1)(C) and (D) of the FD&C Act, nutrition information in food labeling must include the total number of calories, derived from any source and derived from the total fat, and the amounts of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein. For purposes of this proposed rule, we consider the nutrients that are explicitly required by the FD&C Act to be declared on the Nutrition Facts label as ‘‘statutorily required nutrients.’’ Section 403(q)(2)(B) of the FD&C Act permits the Secretary, and by delegation, FDA, to remove a statutorily required nutrients from the label or labeling of food, by regulation, if the Secretary determines the information related to that nutrient is not necessary to assist consumers in maintaining healthy dietary practices. FDA regulations require the declaration of the following statutorily required nutrients: Total calories, calories from fat, total fat, saturated fat, cholesterol, PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 11889 sodium, total carbohydrates, sugars, dietary fiber, and total protein (See Ref. 1 for information on regulatory history). As part of the effort to update the Nutrition Facts label, we reconsidered the declaration of these statutorily required nutrients. Our considerations and tentative conclusions on these nutrients are presented within the discussion of individual nutrients in section II. Section 403(q)(2)(A) of the FD&C Act provides that the Secretary (and by delegation FDA) may, by regulation, require other nutrients to be declared if the Secretary determines that a nutrient will provide information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices. For purposes of this proposed rule, we consider such nutrients that are not statutorily required but subject to our discretion under section 403(q)(2)(A) of the FD&C Act, as ‘‘non-statutory nutrients’’ to distinguish such nutrients from those expressly required by the statute. In the 1993 nutrient content final rule (58 FR 2079), we considered the existence of a quantitative intake recommendation highlighted in U.S. consensus reports and the public health significance of the nutrient in exercising our discretion to determine which non-statutory nutrients to require or permit on the Nutrition Facts label. Based on these considerations, with respect to nonstatutory nutrients, we (1) required the declaration of certain essential vitamins and minerals for which an RDI was established and that were determined to have public health significance (i.e., vitamins A and C, iron, and calcium); and (2) permitted the declaration of the remaining essential vitamins and minerals for which there was an established RDI or DRV (i.e., vitamin E) or that had public health significance, as well as permitted the declaration of certain subcategories of macronutrients for which a DRV was not established (including monounsaturated fat, polyunsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate) (58 FR 2079). In this section, we describe our current thinking related to considerations used to determine whether a non-statutory nutrient should be required or permitted to be declared on the Nutrition Facts label. Applying this current thinking, in section II, we are proposing the mandatory declaration of certain non-statutory nutrients, voluntary declaration of others, and proposing to remove the mandatory declaration of another nutrient. For purposes of this proposed rule, we use the term ‘‘nutrient’’ to refer to E:\FR\FM\03MRP2.SGM 03MRP2 11890 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 substances that are currently included or that we are considering for inclusion on the Nutrition Facts label, including carbohydrate, fat, and protein and their subcomponents (e.g., added sugars, sugar alcohols, saturated fat), micronutrients (vitamins and minerals), and to calories, including calories from fat. 1. Factors Considered We updated the information that we consider for determining whether the declaration of a non-statutory nutrient should be mandatory or voluntary. This update responds to several developments. Since the 1993 nutrient content final rule was published, (1) new scientific data have provided additional evidence of the role of certain nutrients in chronic disease risk, healthrelated conditions, or health-related physiological endpoints and, in some cases, based on the review of this evidence, DRIs are now available from the IOM that can be used as quantitative intake recommendations (i.e., RDA and AI), as well as for assessing the inadequacy and adequacy of essential vitamins and minerals in the U.S. population (i.e., EAR and AI); (2) the rates of certain diseases or healthrelated conditions have either changed or remained high; and (3) the process for evaluating the relationship between a nutrient and chronic disease risk, a health-related condition, or a healthrelated physiological endpoint has been refined based on the use of systematic evidence-based reviews for a number of nutrients (e.g., 2010 DGA, FDA health claims). We continue to be mindful of past factors we considered as part of our deliberations related to the Nutrition Facts label, such as the number of nutrients that could be listed in nutrition labeling, that some individuals could interpret a long list of nutrients as implying that a food has greater nutritional significance than is the case, and that there is limited space for nutrition information on the label (55 FR 29487 at 29493; July 19 1990). To help us determine whether a nonstatutory nutrient should be a required or permitted declaration, we are considering the same general types of information used in 1993 when the nutrient content final rule was published: (1) Existence of quantitative intake recommendations; and (2) public health significance. We discuss each of these factors in greater detail in this document. a. Quantitative Intake Recommendations—Quantitative intake recommendations are reference intake levels provided in consensus reports VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 that can be used to set a DRV or RDI. We expect these consensus reports to be published for the purpose of setting quantitative intake recommendations (e.g., the IOM DRI reports). If DRIs are not available for nutrients, other than essential vitamins and minerals, then we consider science-based recommendations from other U.S. consensus reports or the DGA policy reports. Such recommendations may be identified as a conclusion, key recommendation, or reported in the executive summary of the consensus report. b. Public Health Significance—For the purposes of nutrition labeling of foods and dietary supplements, we consider public health significance to refer to two elements. First we consider whether there is evidence of a relationship between the nutrient and a chronic disease, health-related condition, or health-related physiological endpoint. This can be demonstrated either by well-established evidence or, for essential vitamins and minerals, recommendations regarding the health consequences of inadequacy of the nutrient. Second we consider whether there is evidence of a problem related to health in the general U.S. population. This needs to be demonstrated by both evidence of a problem with the intake of the nutrient in the general U.S. population and evidence of the prevalence of the chronic disease, health-related condition, or healthrelated physiological endpoint that is linked to that nutrient in the general U.S. population. We consider public health significance to refer to the following: (1) Existence of ‘‘wellestablished’’ scientific evidence from U.S. consensus reports that there is a relationship between a nutrient and chronic disease risk, a health-related condition, or a health-related physiological endpoint and where the intake of such nutrient is of general importance in the general U.S. population, e.g., where intakes are generally too low or too high among the U.S. population. U.S. consensus reports are those reports that provide consensus conclusions or recommendations by a group of experts as requested by U.S. Government Agencies (e.g., IOM reports, the DGAs, National Institutes of Health (NIH) consensus reports). We generally consider scientific evidence to be ‘‘wellestablished’’ when such consensus reports have determined the evidence to be ‘‘conclusive,’’ ‘‘documented,’’ or ‘‘strong.’’ Evidence that meets the significant scientific agreement standard in section 403(r)(3)(B)(i) of the FD&C Act in support of those nutrients and PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 disease or health-related conditions for which we have authorized a health claim would be considered ‘‘wellestablished’’ evidence for the purposes of what public health significance refers to in this proposed rule; or (2) nutrients for which there are DRIs set by the IOM (i.e., RDA or AI) that are based on chronic disease risk (e.g., osteoporosis), a health-related condition (e.g., blood pressure) or a nutrient deficiency with clinical significance (e.g., low iron storage leading to iron deficiency anemia) for which inadequate intakes of these nutrients are likely to have important clinical consequences. The nutrients for which this may occur are essential vitamins and minerals; and (3) for all nutrients, there is evidence of inadequate or excess intake of the nutrient based on national nutritional survey data or U.S. consensus reports, and that a substantial prevalence exists in the general U.S. population of the chronic disease, health-related condition, or health-related physiological endpoint that was linked to the particular nutrient (e.g., soluble fiber and coronary heart disease (CHD) risk, calcium and risk of osteoporosis). Because we remain concerned about the large number of nutrients that could be listed as mandatory or voluntary, for essential vitamins and minerals, we are proposing for mandatory declaration, those for which inadequacy has the greatest impact on public health because of their association with a risk of chronic disease, a health-related condition, or a nutrient deficiency with clinical significance (e.g., iron deficiency anemia). The methods used in the evaluation of public health significance of essential vitamins and minerals are discussed in greater detail in section II.H. and the accompanying reference document (Ref. 48). 2. Approach for Mandatory Declaration In general, we continue to consider mandatory declaration appropriate when there is public health significance and a quantitative intake recommendation that can be used for setting a DV (DRV or RDI). However, we have also considered mandatory declaration based, in part, on evidence highlighting the role of a nutrient in chronic disease risk. For example, in 2003, we published a final rule requiring trans fat declaration on the Nutrition Facts label (68 FR 41434). We considered data and information related to the risk of coronary heart disease from consumption of trans fat. In addition, we considered the public health significance of trans fat intake E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules based on consensus reports and federal policy statements. Information related to nutrient intake and its effect on health is not static. Recommendations from various scientific bodies of the U.S. Government that are responsible for public health protection or research directly relating to human nutrition may change or evolve over time. We include, as part of our review of nutrient information in this proposed rule, the current recommendations from such scientific bodies. In section D.3, we specifically consider recommendations from the 2010 DGA related to the intake of added sugars in the diet and the role of such information in assisting consumers to maintain healthy dietary practices. Our review is not based on the factors we have traditionally considered for mandatory declaration that are related to chronic disease, health-related condition, or health-related physiological endpoint linked to the particular nutrient. Instead, our review is based on the need for nutrient information for consumers to implement key dietary recommendations to assist consumers to maintain healthy dietary practices and the need for consumers to be able to readily observe and comprehend the information and to understand its relative significance in the context of a total daily diet. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 3. Approach for Voluntary Declaration For nutrients that are not essential vitamins and minerals (e.g., fluoride, soluble and insoluble fiber, monounsaturated fatty acids and polyunsaturated fatty acids), we consider voluntary declaration to be appropriate when the nutrient either has a quantitative intake recommendation but does not have public health significance, or does not have a quantitative intake recommendation available for setting a DRV but has public health significance. In addition, we consider that voluntary declaration should be permitted for essential vitamins or minerals that we determine do not fit within our considerations for mandatory declaration, but that have an RDI. We invite comment on the factors for considering mandatory and voluntary declaration of non-statutory nutrients. II. The Proposed Rule In this proposed rule, we address issues related to the information declared on the Nutrition Facts label, i.e., declaration of nutrients, definitions, analytical methods, RDIs and DRVs, format, and compliance with declared values. Sections II.A. through II.E. discuss issues related to calories and VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 macronutrients (including fat, fatty acids, cholesterol, carbohydrates, sugars, fiber, and protein), whereas sections II.F. through II.J. discuss issues related to vitamins and minerals, and sections II.K. and II.L. discuss nutrition labeling requirements applicable to certain population subgroups and dietary supplements, respectively. Section II.M. covers issues related to the format of the Nutrition Facts label, followed by section II.N., which focuses on provisions related to compliance and verification. Finally, section II.O. describes technical amendments to existing provisions in § 101.9. As discussed in this document, our evaluation of these issues was informed by current scientific evidence, dietary recommendations, and conclusions of current consensus reports. We took into account any related requests from petitioners and public comments. A. Calories Section 403(q)(1)(C) of the FD&C Act requires the declaration of the total number of calories derived from any source. Correspondingly, FDA regulations require the total caloric content of a food to be declared on the Nutrition Facts label (§ 101.9(c)(1)). We are not proposing to modify the requirement to declare total calories. However, we are reconsidering a number of other requirements related to the declaration of information about calories. The requirements related to ‘‘Calories from fat,’’ ‘‘Calories from saturated fat,’’ the 2,000 reference calorie intake level, and a percent DV for calories are discussed in section II.A., whereas requirements related to prominence of the calorie declaration and the footnote statement and table of DVs for 2,000 and 2,500 calorie diets are discussed in section II.M. 1. Calories From Fat The declaration of ‘‘Calories from fat’’ is mandatory (§ 101.9(c)(1)(ii)). Section 403(q)(1)(C)(ii) of the FD&C Act requires total calories from fat to be declared on the label or labeling of food. Section 403(q)(2)(B) of the FD&C Act provides the Secretary of Health and Human Services (and by delegation, FDA) with discretion to remove the requirement by regulation if the Secretary determines that it is not necessary to assist consumers in maintaining healthy dietary practices. We reviewed current scientific evidence and recommendations in current consensus reports in determining whether information on calories from fat is necessary to assist consumers in maintaining healthy dietary practices. We also considered comments (Ref. 47) PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 11891 to the 2005 and 2007 ANPRMs, in which we requested comment on various questions related to ‘‘Calories from fat’’ declared on the Nutrition Facts label. Unlike dietary recommendations that we relied on during the 1993 rulemaking, current dietary recommendations no longer emphasize total fat. Certain fatty acids are understood to be beneficial, while others are understood to have negative health effects, particularly related to cardiovascular disease (Refs. 6, 36, and 49). Accordingly, the 2005 DGA shifted its focus from total fat reduction to reduction in certain types of fatty acids and their influence on the risk of cardiovascular disease (Ref. 36). The 2002 IOM Macronutrient Report (Ref. 49) set an AMDR for total fat at 20 to 35 percent of calories, recognizing that there were some benefits to consuming moderate amounts of fat (Ref. 49). The 2002 IOM Macronutrient Report and the 2010 DGA (Refs. 6 and 49) concluded that the type of fat consumed was more relevant in reducing the risk of CHD than overall total fat intake. Based on the these dietary recommendations and consensus reports that emphasize intake of total calories and the type of fat consumed, as well as comments to the 2005 and 2007 ANPRMs that supported eliminating the declaration of ‘‘Calories from fat’’ in order to place greater emphasis on total calories (Ref. 47), we tentatively conclude that declaration of ‘‘Calories from fat’’ is not necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are proposing to no longer require, and to not allow voluntarily, the declaration of ‘‘Calories from fat’’ on the Nutrition Facts label. While eliminating the declaration of ‘‘Calories from fat’’ may appear to be a loss of information on the amount of fat being consumed, as some comments suggested, the amount of fat being consumed can still be obtained from the total fat declaration elsewhere on the Nutrition Facts label, and consumers can still use the percent DV for total fat to put fat content in the context of a total daily diet, compare products, and plan diets. Therefore, we are proposing to remove current § 101.9(c)(1)(ii) to remove the requirement for declaration of calories from fat (and redesignate § 101.9(c)(1)(iii) as proposed § 101.9(c)(1)(ii)). We invite comment on the tentative conclusion to no longer require, and to not allow voluntarily the declaration of ‘‘Calories from fat’’ on the Nutrition Facts label. E:\FR\FM\03MRP2.SGM 03MRP2 11892 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 2. Calories From Saturated Fat The declaration of ‘‘Calories from saturated fat’’ is voluntary (§ 101.9(c)(1)(iii)). The 2010 DGA continues to recommend that Americans should consume less than 10 percent of calories from saturated fat (Ref. 6). Saturated fat is known to increase the risk of cardiovascular disease and, unlike ‘‘Calories from fat,’’ which could include calories attributable to fatty acids that decrease or increase the risk of certain diseases, ‘‘Calories from saturated fat’’ would provide information about calories from a source known to increase disease risk (Ref. 49). We considered the recommendations in current consensus reports as well as the comments (Ref. 47) received in response to the 2007 ANPRM requesting comment on whether the declaration of ‘‘Calories from saturated fat’’ should continue to be voluntary or whether it should be mandatory. Based on the recommendations in current consensus reports and supported by many comments, we tentatively conclude that mandatory declaration of ‘‘Calories from saturated fat’’ is not necessary because the amount of saturated fat being consumed can still be obtained from the total saturated fat declaration elsewhere on the Nutrition Facts label. Additionally, as with total fat, consumers can still use the percent DV for saturated fat to put saturated fat content in the context of a total daily diet, compare products, and plan diets. However, because there is strong evidence associating higher intakes of saturated fat with higher low-density lipoprotein (LDL) cholesterol levels, information on ‘‘Calories from saturated fat’’ can assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing to change the current voluntary labeling of ‘‘Calories from saturated fat’’ in the Nutrition Facts label as specified in § 101.9(c)(1)(iii). However, considering our proposal to eliminate the declaration of ‘‘Calories from fat’’ on the Nutrition Facts label (see section II.A.1.), we are proposing to revise § 101.9(c)(1)(iii) and (d)(5) to specify that the statement ‘‘Calories from saturated fat,’’ when declared, must be indented under the statement of calories. In addition, we are proposing to redesignate § 101.9(c)(1)(iii) as proposed § 101.9(c)(1)(ii). 3. Two Thousand Calories as the Reference Caloric Intake Level Per FDA regulations, a reference calorie intake level of 2,000 calories is used to set DRVs for total fat, saturated fat, total carbohydrate, protein, and dietary fiber (§ 101.9(c)(9)). In addition, VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 we require a footnote on the Nutrition Facts label that states, ‘‘Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs,’’ followed by a table with certain DVs based on 2,000 and 2,500 calorie diets (§ 101.9(c)(9)). In reconsidering the 2,000 calories reference intake level, we considered relevant recommendations from the IOM macronutrient report that provided estimated energy requirements (EERs) and the IOM Labeling Report (Refs. 25 and 50). We also considered comments (Ref. 47) received in response to the 2007 ANPRM, in which we asked whether 2,000 calories should continue to be used as the reference calorie intake level and asked questions related to the use of the EERs. An EER is a DRI set by the IOM for energy intake and is defined as the dietary energy intake that is predicted to maintain energy balance in a healthy adult of defined age, gender, weight, height, and level of physical activity consistent with good health. The IOM set EERs for all life-stage and gender groups and based these EERs on normal weight individuals (i.e., BMI < 25) (Ref. 50). The IOM Labeling Committee considered whether there was a basis to use the EERs for developing a new reference calorie intake level for macronutrients in nutrition labeling. The IOM Labeling Committee noted that using the EER to derive a reference calorie intake level would require making assumptions about height, weight, and physical activity level. Furthermore, the equations used to calculate the EERs were based on normal weight individuals; however, the American population has a high prevalence of overweight and obesity. Thus, the IOM Labeling Committee found that the data necessary to use the EER concept as the basis for a reference calorie intake level for nutrition labeling were incomplete and it could not recommend the approach (Ref. 25). The IOM Labeling Committee concluded that retaining the current 2,000 reference calorie intake level would be the best approach as it would provide continuity and would not encourage higher calorie intake and overconsumption of energy (Ref. 25). We agree with the IOM Labeling Report and comments in response to the 2007 ANPRM (Ref. 47) that the EERs do not provide an appropriate basis for the derivation of a reference calorie intake level for the purpose of nutrition labeling. The EERs are influenced by various parameters such as age, gender, height, weight, and physical activity level (PAL), which makes it challenging to combine the EERs into a single PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 reference calorie intake level applicable to the general population. Further, all of the comments supported the use of the 2,000 calorie reference intake level. Therefore, we are not proposing any changes to the current use of 2,000 reference calorie intake level as the basis for setting DRVs for total fat, saturated fat, total carbohydrate, dietary fiber, and protein, as specified in § 101.9(c)(9). 4. Percent DV Declaration for Calories Current regulations do not provide for a DRV for calories. Setting a DRV for calories would necessitate the determination of a quantitative intake recommendation for calories. To determine an appropriate DRV for calories, we reviewed recommendations in current consensus reports. We also considered comments (Ref. 47) received in response to the 2005 and 2007 ANPRMs, in which we asked whether providing a percent DV disclosure for total calories would assist consumers in understanding the caloric content of the packaged food in the context of a 2,000 calorie diet. The IOM macronutrient report is the most recent consensus report that provides quantitative intake recommendations for calories (Ref. 50), and those quantitative intake recommendations are the EERs. For the same reasons that EERs are not appropriate for setting the reference calorie intake level as described previously, these EERs are not appropriate for setting a DV for calories. First, the EERs do not apply to overweight individuals, and are therefore not applicable to a substantial portion of the general population. Second, combining the EERs into a single, meaningful reference value is challenging because they vary by age, gender, height, weight, and PAL. In addition, DRVs were established for those nutrients that are important in diet and health interrelationships and/ or based on caloric intake (55 FR 29476 at 29479; July 19, 1990). Accordingly, most of the DRVs have been based on quantitative intake recommendations associated with chronic disease risk or a health-related condition (e.g., total fat, saturated fat, cholesterol, and dietary fiber). In contrast, the EERs are neither associated with chronic disease risk or a health-related condition, nor are they intended to be treated as a single recommended value that can be applied to the general U.S. population. Thus, we tentatively conclude that there is no appropriate quantitative intake recommendation and we are not aware of any other data or information on which a DRV for calories can be determined. Although a majority of E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules comments to the ANPRMs supported the addition of a percent DV for total calories, we are not persuaded to propose to require or permit such declaration due to the lack of an appropriate quantitative intake recommendation or other data or information on which FDA could rely to establish a DRV for calories. We invite comment on the tentative conclusion not to establish a DRV for calories and include a percent DV for the declaration of calories. Therefore, we are not proposing to set a DRV for calories and, as a result, a percent DV declaration for calories would be neither required nor permitted. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 B. Fat In section II.B., we discuss considerations related to definitions, declaration, and DRVs for total fat, saturated fat, trans fat, monounsaturated fat, and polyunsaturated fat. 1. Total Fat a. Definition—FDA defines ‘‘fat, total’’ or ‘‘total fat’’ in § 101.9(c)(2) as a statement of the number of g of total fat in a serving defined as total lipid fatty acids and expressed as triglycerides. In 1997, we received a citizen petition from Nabisco, Inc. (Docket No. FDA– 1997–P–0476) requesting that FDA amend the definitions of ‘‘total fat’’ and ‘‘saturated fat’’ in its food labeling regulations to clarify that acetic, propionic, and butyric acids may be excluded when calculating the amount of fat in a food product (https:// www.regulations.gov/ # !docketDetail;D=FDA-1997-P-0476). The petitioner’s requests related to the definition and labeling of total fat are presented here and the petitioner’s requests related to the definition of saturated fat are discussed in section II.B.2. With respect to total fat, the petitioner requested that we amend § 101.9(c)(2) to read as follows: ‘‘Fat, total’’ or ‘‘Total fat’’: A statement of the number of g of total fat in a serving defined as total lipid fatty acids, excluding acetic (C:2), propionic (C:3), and butyric (C:4) acids and expressed as triglycerides . . .’’ The petitioner stated that acetic, propionic, and butyric acids (‘‘the acids’’), which have very short two, three, and four carbon chains, respectively, are organic acids that should not be considered fatty acids for food labeling purposes for the following reasons: (1) The acids are chemically different from fatty acids because they are water soluble; (2) the digestion and absorption of the acids are distinctly different from those of fatty acids; (3) the acids are metabolized VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 differently than fatty acids and are biochemically and physiologically more closely related to carbohydrates than to fat; and (4) the acids do not cause the adverse health effects associated with fat and may even have benefits that make them distinct from fat. The petitioner noted that excluding the acids from the definition of fat would not affect current labeling practices because they are found in such small amounts in the food supply. In addition, the petitioner asserted that analytical methods would not be affected because approved AOAC methods for total fat measurement do not detect the acids. We disagree with the petitioner that the acids are chemically different from fatty acids because they are water soluble and that insolubility in water is the essential chemical property of a fat. Fatty acids are monocarbonic acids with chain lengths between 1 and nearly 30 carbon atoms (Ref. 51). The chain length of a fatty acid determines its physical properties (Ref. 51). Short-chain fatty acids are compounds that are soluble in water. As the chain length increases, water-solubility decreases (Ref. 51). Short chain acids such as acetic, propionic, and butyric acids are still considered fatty acids although they are water soluble. Furthermore, the characteristic feature of a fatty acid is a terminal carboxyl group attached to a chain of alkyl groups containing carbon atoms of which these short chain acids are composed (Ref. 52). We determine the amount of the major macronutrients (carbohydrate, fat, and protein) in a food product by their chemical composition. We tentatively conclude that the petitioner did not provide a scientific basis on which we could rely to propose to exclude acetic, propionic, and butyric acids from the definition of total fat based on differences in chemical composition. Moreover, the petitioner did not explain why we should define total fat based on physiological differences identified for such fatty acids compared to other fatty acids, even if true, and not retain our current approach to define total fat based on chemical composition. Therefore, we are not proposing any changes to the current definition of ‘‘total fat.’’ We request comment on our tentative conclusion that acetic, propionic, and butyric acids should not be excluded from the definition of ‘‘total fat.’’ To clarify what we consider to be a fatty acid, we are proposing to define ‘‘fatty acids’’ in § 101.9(c)(2) as ‘‘aliphatic carboxylic acids consisting of a chain of akyl groups and characterized by a terminal carboxyl group.’’ This definition is consistent with other PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 11893 similar definitions found in nutrition and chemistry references (Refs. 51 to 54). We request comment on the proposed definition of fatty acids. b. Mandatory Declaration—Section 403(q)(1)(D) of the FD&C Act requires the declaration of the amount of total fat on food labels. Consequently, the Nutrition Facts label includes the mandatory declaration of the gram amount for total fat in § 101.9(c)(2). The 2010 DGA recognizes that the types of fatty acids consumed are more important in influencing the risk of CVD than the total amount of fat in the diet (Ref. 6). Current dietary recommendations and clinical guidelines encourage replacing saturated and trans fatty acids with beneficial fats, such as polyunsaturated and monounsaturated fatty acids (Refs. 6 and 55). A high intake of most types of saturated fatty acids, trans fatty acids, and cholesterol can increase LDL cholesterol levels, which in turn may increase the risk of CHD (Ref. 49). While there is a significant amount of evidence showing that a diet high in saturated or trans fatty acids may be detrimental to health, there is also evidence that consumption of less than 20 percent of calories from fat can lead to an increased risk of insufficient intake of vitamin E and essential fatty acids (Ref. 49). In addition, consumption of a low fat diet that is high in carbohydrate can lead to a reduction in high density lipoprotein cholesterol concentration and an increase in blood triglycerides, which can result in an increased risk of CHD (Ref. 49). We concur with the 2010 DGA that consuming a diet low in saturated fatty acids and cholesterol is more important for reducing CVD risk than consuming a diet low in total fat. This finding is consistent with the conclusions in the IOM Macronutrient Report (Ref. 49), as well as with current practice guidelines such as the National Heart, Lung, and Blood Institute (NHLBI) Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Ref. 55). Total fat is a calorie-yielding macronutrient and an important piece of the macronutrient profile of a food. However, consumption of inadequate amounts of total fat is also associated with an increased risk of impaired growth and consumption of excessive amounts of total fat is associated with an increased risk of chronic diseases, such as CHD and diabetes (Ref. 49). In addition, the IOM noted that high fat diets are usually accompanied by increased intakes of saturated fatty acids which can increase the risk of CHD (Ref. 49). Thus, we tentatively conclude that E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11894 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mandatory declaration of total fat on the Nutrition Facts label continues to be necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing any changes to the current requirement for mandatory declaration of total fat on the Nutrition Facts label. c. DRV—The DRV for total fat is 30 percent of calories (65 g/d) (§ 101.9 (c)(9)). In developing the DRIs for various nutrients, the IOM cited a lack of data sufficient to determine a defined level of fat intake at which no risk of inadequacy or prevention of chronic disease occurs, and therefore, decided to establish neither an AI nor an RDA for total fat (Ref. 49). Instead, the IOM established an AMDR for total fat intake of 20 to 35 percent of energy for adults and an AMDR of 25 to 35 percent of energy for children age 4 to 18 years. The AMDRs are associated with reduced risk of chronic diseases, such as CHD, while providing for adequate intake of essential nutrients. The 2010 DGA acknowledged the IOM’s AMDR and noted that total fat intake should fall within the AMDRs set by the IOM (Ref. 6). The IOM Labeling Committee recommended that AMDRs should be the basis for DVs for protein, total carbohydrate, and total fat (72 FR 62149 at 62164). Accordingly, for total fat, the IOM Labeling Committee recommended a population-weighted midpoint of the AMDR since AMDRs vary with age. A population-weighted mid-point of the AMDR for adults, i.e., 20 to 35 percent, yields a DRV of 28 percent or 62 g of total fat. The use of the upper level (35 percent of energy) of the AMDR would increase the DRV from 65 g to 78 g for a 2,000 calorie diet. Considering the recommendations of the IOM Labeling Committee, we requested comment, in the 2007 ANPRM, on: (1) Whether a populationweighted midpoint of the AMDR (e.g., 28 percent for adults) should be used, as suggested in the IOM Labeling Report and (2) whether the upper level of AMDR of 35 percent (78 g) should be used. We reviewed the IOM Labeling Committee’s recommendations, IOM DRIs, and comments in response to the 2007 ANPRM (Ref. 47). We tentatively conclude that changing the DRV for total fat to the lower end of 20 percent of 2,000 calories would not be appropriate because: (1) It would not be appropriate for children 4 to 18 years of age because it falls below the lower end of the AMDR (i.e., 25 to 35 percent of energy) and (2) scientific evidence supports consumption of greater than 20 percent of total calories from total fat for VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 reduction in risk of chronic diseases, such as CHD and diabetes (Ref. 49). We also conclude that the upper level of the AMDR of 35 percent of 2,000 calories as the basis for a DRV would provide no meaningful health benefit and that a population-weighted midpoint of 28 percent of the AMDR (28 percent of calories) as the basis for the DRV is not significantly different from a public health outcome standpoint than the current value of 30 percent of calories. Using the population-weighted AMDR midpoint approach would result in an insignificant reduction from the DRV of 65 g (rounded from 30 percent of a 2,000 calorie diet) to 60 g (rounded from 28 percent of calories), which may imply a greater level of precision in a DRV than is actually true. Furthermore, the DRV for total fat is linked to the DRVs for total carbohydrate and protein. For reasons discussed in sections II.D. and II.E., we are not proposing to change the DRVs for carbohydrate or protein at this time. Because the DRV for carbohydrate is determined by difference, an increase in the DRV for fat would result in a decrease in the DRV for carbohydrate. The DRV of 30 percent of calories fits within the AMDR and represents a moderate value that is not close to the upper or lower levels of the AMDR. A majority of comments supported maintaining the current DRV of 30 percent of calories. As noted previously, the DRV for total fat was calculated based on a 2,000 reference calorie intake and the dietary recommendation for fat intake at the time of 30 percent or less of total caloric intake, amounting to 66.7 g of fat, which was rounded down to 65 g. Current dietary recommendations for fat intake provide a range of acceptable intakes (i.e., between 20 and 35 percent of caloric intake) and encompass the 30 percent value that formed the basis for the existing DRV. Therefore, we are not proposing any changes to the current DRV for total fat of 30 percent of calories. 2. Saturated Fat a. Definition—FDA regulations define ‘‘Saturated fat’’ in § 101.9(c)(2)(i) as the sum of all fatty acids containing no double bonds. We received a citizen petition from the American Cocoa Research Institute on April 3, 1996 (Docket No. FDA–1996–P–0035) requesting that the Agency exclude stearic acid from the definition of saturated fat because the petitioner claimed that stearic acid does not raise LDL-cholesterol levels or the risk of CHD (https://www.regulations.gov/ # !docketDetail;D=FDA-1996-P-0035). In the 2007 ANPRM, we did not seek PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 comments on the definition of saturated fat, but received a few comments that requested excluding stearic acid from the definition of saturated fat or permitting a separate listing for stearic acid below the line for saturated fat (Ref. 47). We considered the comments to the 2007 ANPRM and the request by the American Cocoa Research Institute petition, and do not agree that stearic acid should be excluded from the definition of saturated fat. While there is evidence that there are potential differences in the physiological effects of different saturated fatty acids, including on LDL cholesterol levels, the definitions of nutrients for food labeling purposes have traditionally been based on chemical definitions, rather than on individual physiological effects. The definition for saturated fat in § 101.9(c)(2)(i) includes all fatty acids without double bonds and the accepted analytical methods capture all of the saturated fatty acids, including stearic acid. In adopting this definition, we addressed the issue of inclusion/ exclusion of individual saturated fatty acids and determined that a chemical definition (which includes all fatty acids containing no double bonds) was the appropriate approach to define saturated fat (58 FR 2079 at 2088). We further note that the 2010 DGA recommendation related to saturated fat intake is based on scientific evidence related to the intake of all saturated fatty acids combined, which includes stearic acid. The DGA recommendation to consume less than 10 percent of calories from saturated fatty acids makes no specific exclusion of stearic acid and, instead, relates to the intake of total saturated fatty acids (Ref. 6). There are no quantitative intake recommendations for stearic acid. The inclusion of stearic acid in the definition of saturated fat is consistent with our overall approach to rely on chemical definitions of nutrients as the basis for regulatory definitions for food labeling purposes. The American Cocoa Research Institute petition did not provide a basis for why we should deviate from this overall approach to rely on the chemical definition of nutrient as a basis for a regulatory definition. Thus, we are not proposing to exclude stearic acid from the definition of saturated fat. Finally, we also considered voluntary declaration of stearic acid on the Nutrition Facts label, as recommended by a few comments. The effects of stearic acid on LDL cholesterol levels appear to vary depending on the macronutrient component that is replaced by stearic acid (Ref. 30). E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules Moderate evidence indicates that when stearic acid substitutes for other saturated fatty acids or trans fat, plasma LDL cholesterol levels decrease whereas when it replaces monounsaturated or polyunsaturated fatty acids, LDL cholesterol levels increase (Ref. 30). Considering such scientific data, the 2010 DGAC concluded that the potential effects of changes in dietary intake of stearic acid on the risk of CVD remain unclear. Thus, the evidence for a role of stearic acid in human health (e.g., changes in plasma LDL cholesterol levels) is not well-established. Furthermore, there is no quantitative intake recommendation available for stearic acid. Therefore, we tentatively conclude that the individual declaration of stearic acid is not necessary to assist consumers in maintaining health dietary practices, consistent with the factors we consider, discussed in section I.C., and therefore the declaration would not be permitted on the Nutrition Facts label. As discussed in section II.B.1., we received a citizen petition from Nabisco, Inc. on May 7, 1997 (Docket No. FDA– 1997–P–0476) requesting that FDA amend the definitions of ‘‘total fat’’ and ‘‘saturated fat’’ in its food labeling regulations to exclude acetic, propionic, and butyric acids (https:// www.regulations.gov/ # !docketDetail;D=FDA-19970-P-0476). With respect to saturated fat, the petition requested that FDA amend § 101.9(c)(2) to read as follows: (i) ‘‘Saturated fat,’’ or ‘‘Saturated’’: A statement of the number of g of saturated fat in a serving defined as the sum of all fatty acids, excluding acetic (C:2), propionic (C:3), and butyric (C:4) acids, containing no double bonds.’’ For the same reasons discussed in section II.B.1. regarding total fat, we are not proposing to exclude acetic, propionic, and butyric acids from the definition of saturated fat. b. Mandatory Declaration—Section 403(q)(1)(D) of the FD&C Act requires the declaration of the amount of saturated fat on food labels. Accordingly, FDA regulations require mandatory declaration of the gram amount for saturated fat (§ 101.9(c)(2)). Dietary recommendations continue to recognize the well-established relationship between consumption of saturated fat and its effect on blood cholesterol levels (Refs. 6 and 49). In addition, the 2010 DGA provided a quantitative intake recommendation for saturated fat. We are unaware of evidence to support a determination that information relating to saturated fat on the Nutrition Facts label is no longer necessary to assist consumers in maintaining healthy dietary practices. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Therefore, we are not proposing to change the requirement for mandatory declaration of saturated fat on the Nutrition Facts label in § 101.9(c)(2)(i). c. DRV—The DRV for saturated fat is 20 g, which is 10 percent of calories based on a 2,000 reference calorie intake level (§ 101.9(c)(9)). The IOM Labeling Committee recommended that the DV for saturated fatty acids (along with trans fatty acids and cholesterol) should be set at a level that is as low as possible in keeping with an achievable healthpromoting diet and consistent with IOM DRIs (Ref. 25). The IOM Labeling Committee suggested that FDA use food composition data, menu modeling, and data from dietary surveys to estimate minimum intakes that are consistent with nutritionally adequate and healthpromoting diets for diverse populations. In the 2007 ANPRM, we asked for public comment on (1) whether the current DRV for saturated fat of 20 g should be retained and (2) whether food composition data, menu modeling, and data from dietary surveys should be used to establish a DRV for saturated fat that is as low as possible while consuming a nutritionally adequate diet. We received several comments in response to these questions (Ref. 47). Current consensus reports that reviewed scientific evidence related to saturated fatty acid intake continue to recommend saturated fat intakes of no more than 10 percent of calories, based on risk of CVD. Specifically, the IOM DRIs recommended that intakes of these fats should be as low as possible while consuming a nutritionally adequate diet (Ref. 49). In addition, confirming the relationship between high intakes of saturated fatty acids and increased risk of unhealthy blood lipid levels and CHD, the 2010 DGA reaffirmed the recommendation to reduce saturated fatty acid intake to less than 10 percent of calories and noted that lowering the intake even more, to 7 percent of calories, can further reduce the risk of CVD (Ref. 6). The 2002 report from the National Cholesterol Education Program of the NIH National Heart, Lung, and Blood Institute established saturated fat intakes of no more than 10 percent of calories as an optimal intake level for reduction of CHD risk while also establishing intakes of no more than 7 percent of calories as a therapeutic intake level for treating CHD (Ref. 55). Although some comments suggested reducing the DRV to 15 g and to lower the DRV to 7 percent of calories, we are not persuaded to do so because the current saturated fatty acid recommendation of less than 10 percent of calories is still appropriate for the general U.S. population and that the PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 11895 existing DRV of 20 g continues to conform to current dietary recommendations as a maximum intake level that covers the general U.S. population. We do not consider the use of food composition data, menu modeling, or dietary survey data as a suitable approach to determine DRVs. We note that the majority of comments opposed the use of such alternative methods to determine the DRV for saturated fat. We established the current DRVs based on quantitative intake recommendations and underlying science on the association between increased intakes and either reduced risk of chronic disease (e.g., dietary fiber and CHD) or increased risk of chronic disease (e.g., saturated fat and CHD). The approach to determine DRVs using food composition data, menu modeling, or dietary surveys has a number of deficiencies. Menu modeling is an approach, based on available foods in the marketplace, to design a set of food items for meals, which will meet certain nutrient or food intake pattern recommendations (Ref. 56). Menu modeling, by its very nature, would not permit the selection of DRVs that are based on scientific evidence related to actual public health outcomes. Furthermore, menu modeling permits the creation of model menus that may be able to meet certain nutrient thresholds through the inclusion of foods that are not representative of the type or quantity of foods eaten in the U.S. population or any specific population and, thus, may result in nutrient intake levels that do not reflect typical diets and, as such, may be unachievable or unreasonable. The use of menu modeling can be appropriate in other circumstances, such as the use of modeling to determine scenarios of highest possible nutrient intake levels or potential nutrient profiles of diets. Thus, food composition data and related models can help provide useful information about consumption trends and the general nutrient content of the food supply and can serve as an additional consideration in choosing a reference point for daily intake that is realistically achievable and practical in light of the current food supply and consumption patterns. However, these data cannot form the primary scientific bases for selecting DRVs. Another challenge with the use of the menu modeling approach is that numerous and rapid changes to food formulations can make it difficult for food composition databases to provide current and accurate estimates of nutrient intakes. Based on these inherent limitations of menu modeling E:\FR\FM\03MRP2.SGM 03MRP2 11896 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 and the data sources used, we tentatively conclude that the menu modeling approach, as recommended in the IOM Labeling Report, is an unsuitable method for determining DRVs (or RDIs). Instead, we intend to continue using science-based recommendations to set DRVs and RDIs. In the case of saturated fat, as explained previously, the existing scientific evidence does not support a change to the current 20 g DRV. Therefore, we are not proposing any changes to the current DRV of 20 g for saturated fat as specified in § 101.9(c)(9). 3. Trans Fat a. Definition—FDA defines ‘‘Trans fat’’ or ‘‘Trans’’ in § 101.9(c)(2)(ii) as the sum of all unsaturated fatty acids that contain one or more isolated (i.e., nonconjugated) double bonds in a trans configuration. In the 2007 ANPRM, we did not seek public comment on the definition of trans fat. However, we received a comment recommending the exclusion of a specific trans fat isomer, vaccenic acid (18:1 t11) from the definition of trans fat because, according to the comment, unlike other trans fat isomers, vaccenic acid may not have adverse health effects. As discussed in the preamble to the final rule regarding trans fat labeling (68 FR 41434 at 41461), we defined trans fatty acids by their chemical structure, not their physiological effects or functional attributes. While the comment provided us with some preliminary observational data suggesting that trans fat from ruminant sources, such as vaccenic acid, may not have the same effects on CHD risk as trans fat from industrial sources, such as partially hydrogenated oils, we do not agree that potential differences in physiological effects should be the basis for determining the specific isomers to be included in a regulatory definition of trans fat. The definition for trans fat is its chemical definition which captures all trans fat isomers that have isolated bonds and, thus, vaccenic acid would be measured by the analytical method used to determine trans fat content of foods. This chemical definition is consistent with how polyunsaturated fat is defined as cis, cis-methylene-interrupted (§ 101.9(c)(2)(ii)). Accordingly, we are not proposing to change the definition of trans fat in § 101.9(c)(2)(ii). b. Mandatory Declaration—FDA regulations require the declaration of trans fat on the Nutrition Facts label (§ 101.9(c)(2)(ii). Dietary recommendations continue to recognize the well-established relationship between consumption of trans fat and its effect on blood cholesterol levels VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 (Ref. 6). Furthermore, under section 403(r)(3)(C) of the FD&C Act, we did not object to a 2006 Food and Drug Administration Modernization Act of 1997 (FDAMA) notification for the health claim ‘‘Diets low in saturated fat and cholesterol, and as low as possible in trans fat, may reduce the risk of heart disease,’’ based on statements made in the 2005 DGA (Ref. 57). As such, because of its role in chronic disease, trans fat continues to be a nutrient with public health significance. We are unaware of evidence to support a determination that information relating to trans fat on the Nutrition Facts label is not necessary to assist consumers in maintaining healthy dietary practices. We tentatively conclude that information on the amount of trans fat in food products allows consumers to reduce their intake of trans fat, and thus, reduce the risk of CHD. Therefore, we are not proposing any changes to the requirement for mandatory declaration of trans fat on the Nutrition Facts label in § 101.9(c)(2)(ii). However the Agency recently published a tentative determination that partially hydrogenated oils, the source of industrially produced trans fat, may not be generally recognized as safe (78 FR 67169; November 8, 2013). We request comment on whether mandatory labeling of trans fat would still be necessary if this determination is finalized. Per § 101.9(c)(2)(ii), if a food contains less than 0.5 g of trans fat per serving, the content, when declared, is to be expressed as zero. We received a citizen petition from an individual on January 17, 2007 (Docket No. FDA–2007–P– 0404) which requested that FDA amend the definition of trans fat in its food labeling regulations to express the value of ‘‘zero’’ for trans fat only when there are ‘‘absolutely no trans fats at all’’ and require the use of a symbol (e.g., ‘‘∼’’) to indicate when there is ‘‘more than zero but less than 0.5g of trans fat per tablespoon’’ (https:// www.regulations.gov/ # !docketDetail;D=FDA-2007-P-0404). The petition claimed that the declaration of zero trans fats on the label is misleading to consumers because it does not denote the absence of trans fat (as ‘‘zero’’ is defined in Webster’s Dictionary) and that people will consume a food incorrectly thinking that it has zero amount of trans fat. The petition stated that, because trans fat is associated with negative effects on heart health, this situation could be detrimental to people’s health. Validated analytical methodologies that provide sensitive and reliable estimates of trans fatty acids in all foods PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 at levels below 0.5 g per serving are currently not available. For most nutrients declared on the nutrition label, the maximum amount permitted for a declaration of a zero value is governed by the limitations associated with analytical methods available to determine the content of a nutrient in a food. The analytical methods used to determine nutrient content for purposes of compliance are discussed in more depth in section II.N. The petition did not provide any information on alternative analytical methodologies that are more sensitive and reliable nor did the petition provide any evidence to support the claim that consumers are misled by the provisions for the declaration of zero trans fat. Thus, we are not proposing any changes to the requirement for the declaration of zero when trans fat content is less than 0.5 g per serving. c. DRV—FDA regulations do not provide a DRV for trans fat. At the time of the issuance of the trans fat final rule, we concurrently issued the 2003 ANPRM in the same issue of the Federal Register (68 FR 41507) to solicit information and data on several trans fat labeling issues. In the 2007 ANPRM, we again requested comments on various issues related to the DV for trans fat, including the use of food composition data, menu modeling and data from dietary surveys, and a potential joint percent DV for trans fat and saturated fat. We received several comments in response to the 2007 ANPRM. We considered the recommendations in the IOM Labeling Report, available scientific evidence, and comments (Ref. 47) received in response to both the 2003 and 2007 ANPRMs. i. Use of food composition data, menu modeling, and dietary surveys. FDA considered the approach recommended in the IOM Labeling Report to use food composition data, menu modeling, and dietary survey data to estimate a minimum trans fat intake within a nutritionally adequate diet. As explained previously (see section II.B.2.c.), we do not consider food composition data, menu modeling, or dietary survey data suitable for determining DRVs. Furthermore, such an approach is not linked to a health outcome, which we have traditionally used as a basis for determining DRVs. As described in the IOM macronutrient DRI report (Ref. 49), the IOM reviewed the evidence for trans fat and was not able to set a UL for trans fat, which indicates that there is insufficient scientific evidence from which to determine a specific level of trans fat intake that would likely pose no risk of adverse health effects. We continue to E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules adhere to the approach of determining DRVs for a nutrient based on the nutrient’s association with specific health outcomes (e.g., LDL cholesterol levels). As an additional consideration, even if we were to use the menu modeling approach, it would be difficult to apply such an approach for trans fat. Current estimates of trans fat content in food composition databases are not comprehensive and do not include trans fat content for all foods. The levels of trans fat in foods have changed since the publication of the 2003 trans fat final rule, in part due to reformulation of foods (Ref. 58). The numerous and rapid changes to food formulations can make it difficult for food composition databases to provide current and accurate estimates of the usual intake of trans fat. Therefore, we tentatively conclude that the menu modeling approach, as recommended in the IOM Labeling Report, is an unsuitable method for determining an appropriate DRV for trans fat. ii. Determining a DRV. The IOM did not set a UL for trans fat in the DRI macronutrient report. The IOM noted that any increase in trans fat intake increases CHD risk but because trans fats are unavoidable in ordinary diets, consuming zero percent of calories would require significant changes in dietary intake patterns that may introduce undesirable effects and unknown and unquantifiable health risks (Ref. 49). The 2005 and 2010 DGA and the FDA Food Advisory Committee (Refs. 6 and 36) likewise could not set a definitive quantitative intake recommendation for trans fat. Comments generally supported a single trans fat DRV and a single percent DV, but noted that such levels are not possible based on existing science. Although some comments supported a joint percent DV declaration for saturated and trans fat combined, the majority of comments opposed it due in large part to the chemical and physiological differences between these fats. We will consider determining a DRV for trans fat, if and when scientific evidence and relevant dietary recommendations become available. At that time, we will also consider whether a single DRV specific to trans fat or a provision for joint DV declaration for trans fat and saturated fat are appropriate. Thus, we tentatively conclude that there is no basis for setting a DRV for trans fat and, accordingly, we are not proposing a DRV for trans fat, a joint DRV declaration or joint percent DV declaration. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 4. Polyunsaturated Fat Polyunsaturated fats represent two general categories: n-6 and n-3 polyunsaturated fatty acids. The most common n-6 and n-3 polyunsaturated fatty acid in food is linoleic acid and alinolenic acid, respectively. Other n-3 fatty acids found in foods, particularly in fish, are the long chain fatty acids, eicosapentaeneoic acid (EPA) and docosahexaenoic acid (DHA). a. Voluntary Declaration—FDA regulations permit, but do not require, the declaration of polyunsaturated fat (defined as cis, cis-methyleneinterrupted polyunsaturated fatty acids) on the Nutrition Facts label (§ 101.9(c)(2)(iii)). To determine whether any changes are needed to the current provision for voluntary declaration, we considered recommendations of current U.S. consensus reports as well as comments received (Ref. 47) in response to the 2007 ANPRM, in which we requested comment on whether declaration of polyunsaturated fat should continue to be voluntary or made mandatory. Current dietary recommendations advise consumers to increase intakes of polyunsaturated fatty acids to replace saturated fatty acids in their diets (Ref. 6). The 2010 DGA recommends limiting the consumption of saturated fatty acids accompanied with replacing them with polyunsaturated and monounsaturated fatty acids (Ref. 6). However, as discussed in this document, the IOM did not set DRIs for total polyunsaturated fatty acids, but rather provided AIs and AMDRs each for two specific fatty acids, linoleic acid (an n6 polyunsaturated fatty acid) and alinolenic acid (an n-3 polyunsaturated fatty acid) based on median intakes of each fatty acid using NHANES data (Ref. 49). We acknowledge that certain polyunsaturated fatty acids are essential and understand the interest expressed by some comments that there is a need to provide information on beneficial fats. However, the essentiality of a nutrient is not a factor considered for the mandatory or voluntary labeling of non-statutory nutrients, other than essential vitamins and minerals (see section I.C). Although certain polyunsaturated fatty acids are essential, an essential fatty acid deficiency is basically nonexistent in the United States and, therefore, is not of public health significance (Ref. 49). A quantitative intake recommendation is not available from relevant U.S. consensus reports (see discussion in this document), but there is well-established evidence to indicate PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 11897 that replacing saturated fatty acids with polyunsaturated and monounsaturated fatty acids reduces blood LDL cholesterol levels and, therefore, the risk of CVD (Ref. 30). The prevalence of CVD in the U.S. population is substantial (Ref. 30). We are not proposing any changes to the requirement for mandatory declaration of saturated fat (see section II.B.2.). Because polyunsaturated fat has public health significance when it replaces saturated fat, consistent with the factors for voluntary declaration discussed in section I.C., we are proposing to continue to permit voluntary declaration of polyunsaturated fat, as provided in § 101.9(c)(2)(iii). We request comment about whether there is an appropriate alternative analysis to the application of the factors in section I.C. regarding the voluntary declaration of polyunsaturated fat. b. DRV—FDA regulations do not provide a DRV for polyunsaturated fat. The IOM did not set a DRI or AMDR for polyunsaturated fat, but provided AIs and AMDRs for two specific essential fatty acids, linoleic acid (an n-6 polyunsaturated fatty acid) and alinolenic acid (an n-3 polyunsaturated fatty acid) based on median intakes of each fatty acid using NHANES data (Ref. 49). The AIs for linoleic acid and alinolenic acid are 17 and 1.6 micrograms (mcg)/d, respectively. The AMDRs for linoleic acid and a-linoleic acid are 5 to 10 percent of calories and 0.6 to 1.2 percent of calories, respectively. In the 2007 ANPRM, we asked: (1) Whether a DRV for total polyunsaturated fat should be derived based upon AIs for linoleic acid plus alinolenic acid; and (2) whether a DRV for total polyunsaturated fat should be established using the AMDRs for n-6 and n-3 polyunsaturated fatty acids and, if so, should a midpoint be used. We received comments in response to these questions (Ref. 47). We are not able to set an appropriate DRV for polyunsaturated fat at this time given the lack of established DRIs for total polyunsaturated fatty acids. We do not consider that the AMDRs or AIs for linoleic acid and a-linolenic acid provide a sufficient basis on which a DRV for polyunsaturated fat could be derived. The AIs for linoleic and alinolenic acid were set based on U.S. median intake levels because there were insufficient experimental data to set an RDA (Ref. 49). Similarly, the AMDRs for linoleic acid and a-linolenic acid were based on the percent of calories needed to meet the AI for each fatty acid (lower range) and the percent of calories representing the highest intake level of each fatty acid (upper range). As such, E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11898 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules neither of these values provides an adequate basis on which to determine a DRV. For these reasons, we disagree with comments that supported using the sum of AIs or AMDRs to establish a DRV for total polyunsaturated fat. Therefore, we tentatively conclude that there is no appropriate quantitative intake recommendation to form a basis for setting a DRV for polyunsaturated fat. Accordingly, we are not proposing a DRV for polyunsaturated fat. c. Declaration of Individual Polyunsaturated Fatty Acids—The declaration of individual polyunsaturated fatty acids on the Nutrition Facts label is not permitted. The IOM did not set DRIs for total n-6 and n-3 polyunsaturated fatty acids, but established AIs and AMDRs for two specific fatty acids, linoleic acid (an n6 polyunsaturated fatty acid) and alinolenic acid (an n-3 polyunsaturated fatty acid) (Ref. 49). The 2007 ANPRM asked for public comment on whether separate DRVs for linoleic acid and alinolenic acid should be established and, if so, whether the declaration of these nutrients should be voluntary or made mandatory. We received comments in response to these questions (Ref. 47). Linoleic and a-linolenic acids are essential fatty acids that differ physiologically and compete metabolically. Based on a review of relevant scientific research, in 2004, FDA concluded in its qualified health claim review that there is supportive, but not conclusive, research to suggest that n-3 polyunsaturated fatty acids (EPA and DHA) reduce the risk of CHD (Ref. 59). Results of one clinical trial on the effects of EPA published since 2004 fail to demonstrate a significant reduction in the hazard ratio for the primary prevention of major coronary events (Ref. 60). More recently, the 2010 DGAC concluded that moderate evidence shows that the consumption of two servings of seafood per week, which provides an average of 250 mg/d of longchain n-3 polyunsaturated fatty acids (i.e., EPA and DHA), is associated with reduced cardiac mortality from CHD or sudden deaths, both in persons with and without CVD (Ref. 30). The DGAC also concluded that the evidence for plant-derived n-3 polyunsaturated fatty acids (i.e., a-linolenic acid) in reducing mortality among persons with existing CVD is limited (Ref. 30). Similarly, there is no conclusive evidence for an independent role of n-6 polyunsaturated fatty acids in reducing blood cholesterol levels and, consequently, the risk of CHD. Evidence suggests that the benefit of n-6 polyunsaturated fatty acids is VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 observed only as a result of a reduction in saturated fatty acid intake (Refs. 6 and 59). The IOM noted that the evidence for a role of EPA and DHA in CHD risk is growing (Ref. 49), but set AIs and AMDRs for a-linolenic acid, not for EPA or DHA. While a ‘‘healthy’’ n-6:n-3 ratio may be important in human health, such a ratio has not been defined and much of the available evidence is based on studies conducted in animals, infants, and patients on total parenteral nutrition and much of the evidence in adults has come from observational studies (Ref. 49). Because of the lack of wellestablished evidence for a role of n-3 or n-6 polyunsaturated fatty acids in chronic disease risk and the lack of a quantitative intake recommendation, and consistent with the factors discussed in section I.C., we tentatively conclude that the declarations of n-3 and n-6 polyunsaturated fatty acids are not necessary to assist consumers to maintain healthy dietary practices. Accordingly, we are not proposing to provide for the individual declaration of either n-3 or n-6 polyunsaturated fatty acids on the Nutrition Facts label. Similarly, because of the lack of wellestablished evidence for a role of EPA and DHA in chronic disease risk and the lack of a quantitative intake recommendation, consistent with the factors discussed in section I.C., we tentatively conclude that the declarations of EPA and DHA are not necessary to assist consumers to maintain healthy dietary practices. Accordingly, we are not proposing to provide for the mandatory or voluntary declaration of EPA or DHA on the Nutrition Facts label. We request comment about whether there is an appropriate alternative analysis to the application of the factors in section I.C. regarding the individual declaration of n-3 or n-6 polyunsaturated fatty acids, as well as EPA or DHA. 5. Monounsaturated Fat a. Voluntary Declaration—FDA regulations currently permit, but do not require, the declaration of monounsaturated fat (defined as cismonounsaturated fatty acids (e.g., oleic acid)) on the Nutrition Facts label (§ 101.9(c)(2)(iii)). To determine whether any changes are needed to the provision for voluntary declaration, we considered recommendations in current consensus reports as well as comments received in response to the 2007 ANPRM (Ref. 47), in which we requested comment on whether declaration of monounsaturated fat PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 should remain voluntary or be made mandatory. In 2002, the IOM noted that there was no known independent role of monounsaturated fatty acids in preventing chronic disease (Ref. 49). The lack of an independent effect of monounsaturated fatty acids on heart disease risk was also substantiated in a 2004 FDA review of a qualified health claim regarding monounsaturated fatty acids from olive oil and CHD (Ref. 61). Upon review of data related to this qualified health claim, we concluded that there was no evidence to indicate that monounsaturated fatty acids from olive oil, independent of saturated fatty acid displacement, lower serum total and LDL cholesterol levels. Most recently, the 2010 DGAC (Ref. 30) noted that there was strong evidence indicating that monounsaturated fatty acids are associated with improved blood lipids related to CVD when they replace saturated fatty acids. Consequently, the 2010 DGA recommends that most fats should be consumed as polyunsaturated and monounsaturated fatty acids (Ref. 6). Current dietary recommendations advise consumers to increase intakes of monounsaturated fatty acids to replace saturated fatty acids in their diets. We acknowledge that monounsaturated fatty acids are not essential in the diet (Ref. 49). However, a lack of essentiality is not a basis for determining whether a nutrient should be required to be declared (see section I.C.). Indeed, nonessential nutrients trans fat, saturated fat, and cholesterol are required to be declared on the label because of their public health significance. Scientific evidence points to the positive effects of increased monounsaturated fatty acid intake as a result of reduced intake of saturated fatty acids. While a quantitative intake recommendation is not available from relevant U.S. consensus reports, there is well-established evidence to indicate that replacing saturated fatty acids with polyunsaturated and monounsaturated fatty acids reduces blood LDL cholesterol levels and, therefore, the risk of CVD, and that the prevalence of CVD is substantial in the United States (Ref. 30). We are not proposing any changes to the current requirement for mandatory declaration of saturated fat (see section II.B.2.). Because monounsaturated fat has public health significance when it replaces saturated fat, consistent with the factors we consider for voluntary declaration discussed in section I.C., we are proposing to continue to allow for voluntary declaration of E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules monounsaturated fat, as provided in § 101.9(c)(2)(iii). We request comment about whether there is an appropriate alternative analysis to the application of the factors in section I.C. regarding the voluntary declaration of monounsaturated fat. b. DRV—FDA regulations do not provide a DRV for monounsaturated fat. Current consensus reports do not provide specific quantitative intake recommendations for monounsaturated fatty acids. The IOM did not set a DRI for monounsaturated fatty acids because these fatty acids are not essential in the diet and have no known independent role in preventing chronic diseases (Ref. 49). Therefore, we tentatively conclude that there is no scientific basis on which we can rely to set a DRV for monounsaturated fat and, therefore, we are not proposing to set a DRV for monounsaturated fat. C. Cholesterol 1. Mandatory Declaration Section 403(q)(1)(D) of the FD&C Act requires the declaration of the amount of cholesterol on food labels, and cholesterol content must be declared on the Nutrition Facts label in accordance with § 101.9(c)(3). Current dietary recommendations continue to recognize the well-established relationship between consumption of cholesterol and its effect on blood cholesterol levels, which are a surrogate endpoint for CHD risk (Ref. 6). In addition, the 2010 DGA provided a quantitative intake recommendation for cholesterol (Ref. 6) (see discussion in this document). Furthermore, FDA authorized a health claim for dietary saturated fat and cholesterol and risk of CHD, for which we evaluated the scientific evidence on the association between dietary cholesterol and serum cholesterol levels (§ 101.75). We are unaware of evidence that would support a change to the requirement for mandatory declaration of cholesterol on the Nutrition Facts label in § 101.9(c)(3) and, therefore, we are not proposing any changes to the current requirement for mandatory declaration. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 2. DRV FDA regulations provide a DRV for cholesterol of 300 mg (§ 101.9(c)(9)). The IOM Labeling Committee recommended, based on the IOM DRIs, that the DV for cholesterol (along with saturated fat and trans fat) should be set at a level that is as low as possible in keeping with an achievable healthpromoting diet (Ref. 25). The IOM Labeling Committee suggested that FDA VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 use food composition data, menu modeling, and data from dietary surveys to estimate minimum intakes that are consistent with nutritionally adequate and health-promoting diets for diverse populations (Ref. 25). Acknowledging these IOM recommendations, in the 2007 ANPRM, we asked for public comment on (1) whether the current DRV for cholesterol of 300 mg should be retained; and (2) whether food composition data, menu modeling, and data from dietary surveys should be used to establish a DRV for cholesterol that is as low as possible while consuming a nutritionally adequate diet. We considered recommendations in current consensus reports as well as comments received (Ref. 47). The 2010 DGA recommends consuming less than 300 mg/d of cholesterol to help maintain normal blood cholesterol levels and reducing intake to less than 200 mg/d for individuals at high risk of CVD (Ref. 6). The IOM also reported a relationship between increased cholesterol intake and increase in serum cholesterol, a surrogate endpoint for CHD risk (Ref. 62). The IOM macronutrient report recommended that cholesterol intakes should be as low as possible while consuming a nutritionally adequate diet, but did not set ULs for cholesterol (Ref. 62). Based on the reasons set forth previously, we disagree with the comments suggesting that a DRV of 300 mg is too low or that there is no strong association between cholesterol intake and CHD risk, or that current science justifies eliminating the percent DV declaration. We do not agree with the IOM recommendation that food composition data, menu modeling, and data from dietary surveys offer a suitable approach for determining DRVs. Limitations inherent to menu modeling and food composition and dietary survey data sources are discussed in sections II.B.2.c. and II.B.3.c. We established the current DRV for cholesterol based on quantitative intake recommendations that considered specific effects on health outcomes (e.g., CHD) (58 FR 2206 at 2217). Use of menu modeling to determine a quantitative intake recommendation for cholesterol is inconsistent with this approach and may result in a reference intake level that is not based on scientific evidence related to actual public health outcomes. Although the 2010 DGA recommends that cholesterol intake levels should be less than 200 mg/d for individuals at high risk of CVD, we consider the DGA recommendation of 300 mg/d for maintaining normal blood cholesterol PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 11899 levels as an appropriate basis for setting a DRV because it represents the maximum intake level that covers the general U.S. population 4 years of age and older. Therefore, we are not proposing any changes to the DRV for cholesterol of 300 mg specified in § 101.9(c)(9). D. Carbohydrate In this section, we discuss our consideration of provisions related to definitions, declarations, DRVs, and analytical methods for total carbohydrate, total sugars, added sugars, dietary fiber, soluble and insoluble fiber, sugar alcohols, and other carbohydrates. 1. Total Carbohydrate a. Calculation of Total Carbohydrate— For the purposes of the Nutrition Facts label, total carbohydrate content is calculated by subtracting the sum of protein, total fat, moisture, and ash from the total weight of the food (§ 101.9(c)(6)). This calculation method is called ‘‘carbohydrate by difference’’ and is described in A.L. Merrill and B.K. Watt, ‘‘Energy Value of Foods—Basis and Derivation,’’ in the USDA Handbook No. 74 (Ref. 63). Total carbohydrate includes starch, sugars, sugar alcohols, and dietary fiber. On July 8, 2004, the National Starch and Chemical Company (National Starch) submitted a citizen petition requesting that dietary fiber content be excluded from the calculation of total carbohydrate that is declared on the Nutrition Facts label (Docket No. FDA– 2004–P–0094) (https:// www.regulations.gov/ # !docketDetail;D=FDA-2004-P-0094). The petition noted that consumers wishing to reduce their intake of carbohydrate may also be inadvertently decreasing their consumption of high fiber foods, such as whole grains, because dietary fiber is included in the definition of ‘‘Total Carbohydrate.’’ National Starch, therefore, requested an amendment to the second sentence in § 101.9(c)(6) to read as follows: ‘‘Total carbohydrate content shall be calculated by subtraction of the sum of the crude protein, total fat, moisture, ash, and dietary fiber from the total weight of the food.’’ The petition noted that excluding dietary fiber from the definition would be consistent with the way the IOM DRI report and Codex guidelines refer to carbohydrates and would be a more accurate representation of the amount of calories contributed by carbohydrates. To support this request, the petition presented study findings reported in the New York Times in 2004 and from research conducted on the Internet. In E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11900 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules addition, the petition discussed the use of the term ‘‘net carbs’’ in labeling and discussed inconsistencies in the way different manufacturers define the term ‘‘net carbs.’’ According to the petition, some manufacturers define ‘‘net carbs’’ as the amount of total carbohydrate excluding the amount of dietary fiber and sugar alcohols while others exclude sugar alcohols and ‘‘other carbohydrates,’’ as specified in § 101.9(c)(6)(iv), or sugar alcohols and ‘‘certain other carbohydrates.’’ The petition suggested that the varied approaches to describing carbohydrates have led to consumer confusion. In the 2007 ANPRM, we asked for comment on whether the approach for calculating total carbohydrate by difference should be retained and, if not, which specific components should be included or excluded from the calculation of total carbohydrate. In addition, acknowledging the 2005 DGA recommendation to consume fiber-rich foods, we asked for comment on whether separating dietary fiber from the amount of total carbohydrate would affect consumer understanding and use of the information, particularly with respect to fiber consumption. We received several comments (Ref. 47). We reviewed scientific evidence and considered the petition’s requests and comments received. As explained in this document, we decline to change to the current method for calculating total carbohydrate by difference. Under FDA regulations, compliance with certain nutrition labeling requirements may be achieved by the use of an FDA-approved database (§ 101.9(g)(8)). Nutrient databases include carbohydrate values that are determined by difference. Changing the way carbohydrate is calculated would either necessitate an analogous change to the way carbohydrate is calculated in major nutrient databases, such as the USDA National Nutrient Database for Standard Reference, or would substantially decrease the usefulness of these databases in assisting manufacturers in making nutrient content declarations. We also considered an alternative approach of calculating total carbohydrates by summing individual carbohydrate measurements rather than calculating by difference, as suggested by a comment. There is variability and error that are introduced with each analytical test that is performed (Ref. 64). When summing the values from the various tests, the amount of variability and error would multiply and such an approach is likely to result in greater variability and error. As discussed in the documentation for USDA’s National VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Nutrient Database for Standard Reference, Release 23, when the analyses of starch, sugars, sugar alcohol, and dietary fiber are performed separately, the result reflects the analytical variability inherent to each of those measurement processes (Ref. 65). Thus, such an approach does not provide any distinct advantage over measuring carbohydrate by difference. With respect to removal of dietary fiber from the calculation of total carbohydrate, we agree that the IOM provided separate DRIs for carbohydrate (i.e., starch and sugars) and dietary fiber. However, the IOM DRI Report does not provide recommendations for nutrition labeling. Furthermore, the report defines dietary fiber as ‘‘nondigestible carbohydrates and lignin that are intrinsic and intact in plants’’ (Ref. 66). Thus, the report acknowledges that dietary fibers, with the exception of lignin, are carbohydrates. As discussed in section II.D.5., the definition of dietary fiber adopted by Codex in 2010 specifies that dietary fibers are carbohydrate polymers (Ref. 67). The Codex Guidelines on Nutrition Labeling, however, indicate that the nutrient declaration for carbohydrate should be ‘‘available carbohydrate,’’ which is the amount of dietary carbohydrate, excluding dietary fiber (Ref. 67). The petition states that the inclusion of dietary fibers in the calculation of total carbohydrate is not fully aligned with the Codex Guidelines on Nutrition Labeling. Our rationale for including dietary fiber in the calculation of total carbohydrate is based on what is considered to be a carbohydrate. To the extent the petition is requesting the removal of dietary fiber from the total carbohydrate calculation due to its physiological effects, we consider in greater detail in this document the classification and declaration of carbohydrates based on their chemical definition or their physiological effects. As discussed in greater detail in this document, we find that inclusion of dietary fiber in the determination of the label declaration of total carbohydrate is scientifically sound based on our chemical definition of total carbohydrate and the analytical methods used to determine carbohydrate content, as well as being consistent with the way subcategories of other macronutrients, such as fat, are listed on the Nutrition Facts label. Dietary fiber is a subset of carbohydrates. All dietary fibers, with the exception of lignin, are carbohydrate polymers. Although lignin is not a carbohydrate, it is tightly bound to other dietary fibers and cannot be easily isolated using AOAC or equivalent PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 methods. It is, therefore, included in the calculation of total carbohydrate. Further, dietary fiber is a mandatory separate listing on the Nutrition Facts label. Therefore, for consumers who wish to know the carbohydrate content of a food that excludes dietary fiber, this information can be deduced by subtracting the declared amount of dietary fiber from the declared amount of total carbohydrate on the Nutrition Facts label. In addition, a calculation based on eliminating dietary fiber content from the declared value of total carbohydrate would necessitate calculating total carbohydrate by difference using the current method and then subtracting from that number the amount of dietary fiber obtained from separate analysis. This option presents a challenge with respect to the use of existing databases in the United States, which include dietary fiber in the calculation of total carbohydrate. Moreover, the petition provided no references to (and we could not locate) the studies identified in the petition. We have no data or information at this time to indicate that removal of dietary fiber from the declaration of total carbohydrate would promote consumption of dietary fiber due to lower amounts of carbohydrate contents declared in nutrition labeling. Finally, to the extent that the petition seeks to define the term ‘‘net carbs,’’ such a request is outside the scope of this rulemaking. In this proposed rule, we are considering whether to propose a change in how ‘‘total carbohydrate’’ is calculated. Therefore, to the extent the petitioner is requesting to remove ‘‘dietary fiber’’ from the total carbohydrate calculation to prevent consumer confusion from the term ‘‘net carb,’’ we decline to change the calculation of total carbohydrate by difference on that basis. We consider the calculation and declaration of ‘‘net carbs’’ and the total carbohydrate calculation and declaration on the label as separate and distinct. The declaration of total carbohydrate is required under section 403(q)(1)(D) of the FD&C Act. For these reasons, we decline to change the method for calculating total carbohydrate by difference and, therefore, we are not proposing any changes to the method for calculating total carbohydrate by difference specified in § 101.9(c)(6). b. Classification of Carbohydrates Based on a Chemical Definition or Physiological Effect—In the 2007 ANPRM, we asked for comment on whether carbohydrates should be classified and declared in nutrition labeling based on their chemical E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules definition (current method) or on their physiological effect (e.g., attenuation of blood sugar or laxation if dietary fiber were to be included in the total carbohydrate declaration), and whether additional types of carbohydrates (e.g., starch) should be listed separately on the Nutrition Facts label. We received several comments (Ref. 47) in response to these questions. We considered this issue in light of the comments received. We agree with the comments that stated that classification of carbohydrates based on validated analytical techniques, which isolate and measure the individual carbohydrates based on their chemical structure rather than based on their physiological effects, is necessary for determining the accuracy of values declared on the label. Carbohydrates include starch, sugars, sugar alcohols, and dietary fibers. Different types of carbohydrates have different physiological effects. The effects of some carbohydrates are not fully understood and are the subject of debate in the scientific community. Within the different types of carbohydrate (i.e., starch, sugars, sugar alcohols, and dietary fibers), too, specific carbohydrates may have different physiological effects (e.g., different types of dietary fibers) making it difficult to apply a definition that is based on physiological effects across a category of carbohydrates. Furthermore, analytical methods for measuring different types of carbohydrates are based on chemical structure rather than physiological effect. Given the various components of total carbohydrate and different types of physiological effects of each, we disagree that a definition based on ‘‘physiological effects’’ would be a better approach than a chemical definition for total carbohydrate declaration. The use of a chemical definition is also consistent with the classification and declaration of fat on the Nutrition Facts label. Different types of fats identified in nutrition labeling are not classified based on their physiological effect but rather on their chemical definition. Therefore, we are not proposing to use physiological effects of carbohydrates as a basis for classifying or declaring total carbohydrate. Accordingly, we are not proposing to change our provisions for the classification or declaration of carbohydrates specified in § 101.9(c)(6). c. Separate Declaration of Additional Individual Types of Carbohydrates—In the 2007 ANPRM, we asked whether additional types of carbohydrates (e.g., starch) should be listed separately on the Nutrition Facts label. We considered comments received (Ref. 47), which, VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 taken together, did not support declaration of additional types of carbohydrates. Some comments stated that such additional information could distract consumers from information that is important, such as dietary fiber. A few comments that supported the declaration of starch provided no evidence to support their assertions regarding the benefit of this declaration for diabetics. Moreover, there is no strong scientific evidence for us to consider related to the role of starch in human health. Therefore, we are not proposing to require the separate declaration of additional types of individual carbohydrates such as starch on the Nutrition Facts label. d. Mandatory Declaration—Section 403(q)(1)(D) of the FD&C Act requires the declaration of total carbohydrate. Correspondingly, regulations require the declaration of the amount of total carbohydrate on the Nutrition Facts label (§ 101.9(c)(6)). Carbohydrates are an essential part of the diet because they provide energy to the cells in the body, especially the brain, which is dependent on carbohydrate for proper functioning (Ref. 68). We have no basis on which to reconsider the requirement for mandatory declaration of the amount of total carbohydrate on the Nutrition Facts label and comments in response to the 2007 ANPRM also supported this mandatory declaration. We tentatively conclude that the declaration of carbohydrates on the Nutrition Facts label continues to be necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing any changes to the current requirement for mandatory declaration of total carbohydrate, as specified in § 101.9(c)(6). e. DRV—The DRV for total carbohydrate is 300 g (§ 101.9(c)(9)). The IOM established an AMDR for carbohydrate intake of 45 to 65 percent of energy for adults and an EAR of 100 g/d for adults and children (Ref. 69). In the IOM report, ‘‘carbohydrate’’ only included starch and sugars, not sugar alcohols or dietary fiber. The IOM also set the RDA for ‘‘carbohydrate’’ (i.e., starch and sugars) at 130 g/d for adults and children based on the average minimum amount of glucose utilized by the brain in adults, which was extrapolated to children ages 1 through 18 years. Subsequently, the IOM Labeling Committee recommended that, as in the case of protein and total fat, the AMDRs should be the basis for DVs for total carbohydrate (Ref. 25). Considering that AMDRs vary with age, the IOM Labeling Committee recommended a population-weighted midpoint of the AMDR. Under this approach, using a PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 11901 population-weighted mid-point of the AMDR for adults and children, i.e., 45 to 65 percent, the DV for total carbohydrate would amount to 55 percent or, based on a 2,000 calorie reference calorie intake, 275 g of carbohydrate. However, as we noted in the 2007 ANPRM, the IOM’s AMDR, EAR, and RDA values for carbohydrate do not include sugar alcohols or dietary fiber. In contrast, our calculation of total carbohydrates for the purposes of nutrition labeling accounts for all types of carbohydrates, including sugar alcohols and dietary fiber. Therefore, applying the IOM Labeling Committee’s approach, in which a DV is derived from the AMDR, would result in a reference value based on recommendations specifically for sugars and starches, whereas the absolute gram amount of carbohydrates declared on the label includes all carbohydrates. Consequently, if the midpoint of the AMDR range is used as the basis for the DRV, there would be a discrepancy in what carbohydrates are encompassed in the information provided on the label for the absolute gram amount versus the percent DV. We did not ask any questions about the DRV for total carbohydrate in the 2007 ANPRM nor did we receive any comments on this issue. Consistent with calculating total carbohydrate ‘‘by difference’’ (discussed previously), we are proposing no changes to the approach to calculate the percent DV for carbohydrate ‘‘by difference’’ as well. In addition, we are not proposing to change the DRVs for fat or protein (see sections II.B. and II.E.), which are used to derive the DRV for total carbohydrate. Therefore, we are not proposing any changes to the DRV for total carbohydrate of 300 g/d. We note that the RDA for carbohydrate for men and women 19 years of age and older is 130 g/d. Therefore, the DRV should not be viewed as an intake requirement, but as a reference amount. f. Calculation of Calories From Carbohydrate—FDA regulations require that the calories from total carbohydrate be calculated by using the general factor of 4 calories/g of carbohydrate less the amount of insoluble dietary fiber (§ 101.9(c)(1)(i)(C)). We are proposing a new definition of dietary fiber (see section II.D.5.a.i.) that only allows for the declaration of dietary fibers that we have determined to have a physiological effect that is beneficial to human health, as ‘‘dietary fiber’’ on the Nutrition Facts label. Therefore, the new definition of dietary fiber would exclude both soluble and insoluble non-digestible carbohydrates that do not meet the proposed definition. For the purposes of E:\FR\FM\03MRP2.SGM 03MRP2 11902 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 calculating calories from carbohydrate, all soluble and insoluble non-digestible carbohydrates should be excluded from the calculation, not just those known to meet the definition of dietary fiber. To ensure that all soluble and insoluble non-digestible carbohydrates are excluded from the calculation of calories from carbohydrate, we are proposing to amend § 101.9(c)(1)(i)(C) to require that calories from carbohydrate be calculated using a general factor of 4 calories/g of total carbohydrate less the amount of non-digestible carbohydrates. As discussed in section II.D.5.b.v., a value of 2 calories/g of soluble nondigestible carbohydrates is then added to the calculation. 2. Sugars a. Definition—Sugars are defined in § 101.9(c)(6)(ii) as a statement of the number of g of sugars in a serving. They are the sum of all free mono and disaccharides (e.g., glucose, fructose, lactose, and sucrose). We received a citizen petition on the term ‘‘sugars’’ and, as explained in this document, we are not proposing any changes to the term or its definition for the purpose of nutrition labeling. b. Mandatory Declaration—Section 403(q)(1)(D) of the FD&C Act requires the declaration of sugars. FDA regulations require the declaration of sugars on the Nutrition Facts label (§ 101.9(c)(6)(ii)). The Sugar Association submitted a citizen petition on August 16, 2005 (Docket No. FDA–2005–P–0373) requesting among other things that we eliminate ‘‘sugars’’ as a mandatory nutrient that is declared on the Nutrition Facts label or, alternatively, rename ‘‘sugars’’ as ‘‘sugars/syrup’’ and require the mandatory declaration of polyol and artificial sweeteners on the Nutrition Facts label, as well as the mandatory labeling of each specific polyol and artificial sweetener ingredient and its amount on the food label (https://www.regulations.gov/ #!docketDetail;D=FDA-2005-P-0373). The petition asserted that consumers understand ‘‘sugars’’ to mean sucrose. The petition stated that an increasing number of manufacturers are using artificially produced (alternative) sweeteners, such as high fructose corn syrup, instead of sucrose products such as table sugar. The petition also asserted that, under current regulations, information on sugar content is presented in a manner that is misleading to consumers because it does not reflect the caloric content of artificially produced sweeteners and does not identify the specific sweeteners used in food products. The petition also VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 expressed concern about the potential caloric and health effects of alternative sweeteners and asserted that the current labeling of sugar and lack of labeling for artificially produced sweeteners on the Nutrition Facts label did not provide consumers with relevant information about alternative sweeteners. However, the petitioner did not include any data to specifically support these assertions and concerns. In the 2007 ANPRM, we requested comment on whether ‘‘sugars’’ should continue to be included on the Nutrition Facts label. We received several comments which were in favor of continuing to require mandatory labeling of sugars on the Nutrition Facts label (Ref. 47). We considered the petition and comments received in light of scientific evidence. There is strong and consistent evidence based on valid endpoints that consumption of sugars is associated with an increased risk of dental caries (Refs. 6 and 68). We authorized a health claim for dietary non-cariogenic carbohydrate sweeteners and dental caries (§ 101.80). The IOM macronutrient report noted that dental caries is a condition of public health concern that is associated with consumption of sugars (Ref. 68). Therefore, we tentatively conclude that the declaration of sugars continues to be necessary to assist consumers in maintaining healthy dietary practices, and we are not proposing to change the current requirement for mandatory declaration of sugars. Moreover, we decline the petition’s request to rename ‘‘sugars’’ as ‘‘sugars/ syrups’’ on the Nutrition Facts label. The petition requested that we rename the ‘‘sugars’’ category to prevent consumers from being misled with regard to the ingredients that are permitted to be considered sugars under the current regulation (monosaccharides plus disaccharides such as high fructose corn syrup). The petition, however, did not provide data or information to support the assertion that consumers are misled by the term ‘‘sugars’’ on products containing sweeteners that are a combination of mono and disaccharides, as defined in § 101.9(c)(6)(ii). We are considering using the term ‘‘total sugars’’ in lieu of ‘‘sugars’’ on the Nutrition Facts label if ‘‘added sugars’ declaration is finalized, as proposed. FDA plans to conduct consumer testing of the terms ‘‘total sugars’’ and ‘‘sugars’’ on the Nutrition Facts label (FR 2013– 12824) to determine if use of the term ‘‘total sugars’’ aids consumers in understanding that added sugars are part of the total amount of sugars in product. PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 We also decline the petition’s request to require manufacturers to declare the specific type of artificial sweetener used on the Nutrition Facts label so that consumers can be made aware of the degree of substitution, when artificial sweeteners are substituted for sugars, and the overall level of the artificial sweeteners in the food. Under FDA regulations, artificial sweeteners that are added to a food are required to be declared in the ingredient statement of the label. The petition did not provide any justification that additional information about artificial sweeteners in nutrition labeling is warranted and we have no data to suggest that a declaration of artificial sweeteners is necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing any change to the current requirement for mandatory declaration of sugars on the Nutrition Facts label, as specified in § 101.9(c)(6)(ii). We are also not proposing to rename the ‘‘sugars’’ category as ‘‘sugars/syrups’’ or require the mandatory declaration of specific sugar alcohols or other artificial sweeteners. c. DRV—FDA regulations do not specify a DRV for sugars. Current consensus reports have not set dietary reference values based on which we could derive an appropriate DRV for total sugars. While the IOM found an association between sugar consumption and risk of dental caries, due to the various factors that contribute to dental caries, IOM could not determine an intake level of sugars that is associated with increased risk of dental caries and, therefore, did not have sufficient evidence to set a UL for sugars (Ref. 68). We did not ask any questions related to the DRV for sugars in the 2007 ANPRM nor did we receive any comments recommending the establishment of a DRV for total sugars. For these reasons, we are not proposing to establish a DRV for total sugars. 3. Added Sugars a. Declaration—FDA regulations neither define the term ‘‘added sugars’’ nor require or permit its declaration on the Nutrition Facts label. We are reconsidering the declaration of added sugars taking into account new data and information, including U.S. consensus reports and recommendations related to the consumption of added sugars, a citizen petition submitted by the CSPI, and public comments. For the purposes of the discussion in this document, added sugars refer to sugars and syrups that are added to foods during processing or preparation (Ref. 6). E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules i. Consensus Reports. The IOM DRI Report on Macronutrients stated that ‘‘although added sugars are not chemically different from naturally occurring sugars, many foods and beverages that are major sources of added sugars have lower micronutrient densities compared to foods and beverages that are major sources of naturally occurring sugars’’ (Ref. 68). Although an upper level was not set for total or added sugars, a maximal intake level of 25 percent or less of energy from added sugars was suggested based on data that demonstrated decreased intakes of some micronutrients among American subpopulations whose intake of added sugars exceeded this level. In addition, the 2010 DGA (Ref. 6) noted that the primary prevention of obesity, especially in childhood, is an important strategy for combating and reversing the obesity epidemic. Over the last few decades, the prevalence of overweight and obese individuals in the United States dramatically increased among children, adolescents and adults. Many factors contribute to weight gain and obesity but maintaining an appropriate calorie balance and increasing physical activity and reducing sedentary behaviors are key recommendations to help combat the problem. The 2010 Dietary Guidelines Advisory Committee (DGAC) concluded that strong evidence shows that children who consume more sugar-sweetened beverages have greater adiposity (body fat) compared to those with a lower intake. The sole source of calories in many sugar-sweetened beverages (e.g., soda) is added sugars. The 2010 DGA specifically suggest that reducing the intake of sugar-sweetened beverages may help individuals control their total calorie intake and manage their body weight. The report stated that Americans consume too many calories from solid fats (fats containing a high percentage of saturated and trans fatty acids and are solid at room temperature) and added sugars and these foods replace nutrient-dense foods and beverages and make it difficult for people to achieve the recommended nutrient intake while controlling their calorie intake. Together, solid fats and added sugars contribute a substantial portion of Americans’ calories, 35 percent on average (16 percent total on average from added sugar) without contributing to the overall nutrient adequacy of the diet and thus have implications for weight management. Thus, to meet nutrient needs within an individual’s calorie limits, a key recommendation of the 2010 DGA is to VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 reduce the intake of calories from solid fats and added sugars. The report recognized that foods containing solid fats and added sugars are no more likely to contribute to weight gain than any other source of calories in an eating pattern that is within calorie limits. However, reducing the consumption of calories from solid fats and added sugars allows for increased intake of nutrient-dense foods without exceeding overall calorie needs. The report recommended several ways to reduce the consumption of solid fats and added sugars including eating the most nutrient-dense forms of foods from all food groups, limiting the amount of solid fats and added sugars when cooking or eating, and consuming fewer and smaller portions of foods and beverages that contain solid fats and added sugars. Specifically, the 2010 DGA noted that, for most people, no more than about 5 to 15 percent of calories from solid fats and added sugars can be reasonably accommodated in the USDA Food Patterns, which are designed to meet nutrient needs within calorie limits. The 2010 DGA also outlined common elements of healthy eating patterns and stated that reducing the intake of added sugars is one component. Although the subject of front-ofpackage labeling (FOP) is outside the scope of this proposed rule, we reviewed the IOM Front-of-package Nutrition Rating Systems and Symbols Committee’s final report for their conclusions on scientific evidence related to the effect of added sugars on human health. This Committee cited the 2010 DGA recommendations related to added sugars and noted that while there is a lack of scientific agreement on the effects of added sugars on health outcomes independent of the effects of total sugar, there is adequate evidence that added sugars (whether a solid or liquid) contribute extra calories to a diet, which could in turn lead to weight gain and obesity (Ref. 28). ii. CSPI Petitions. We received a petition from CSPI on August 3, 1999 (hereafter referred to as ‘‘the 1999 CSPI petition’’) requesting that we require the Nutrition Facts label to disclose the quantity of added sugars present in packaged foods and to set a DRV for refined sugars added to foods (Docket No. FDA–1999–P–0158) (https:// www.regulations.gov/ #!docketDetail;D=FDA-1999-P-0158). The petition stated that the DRV for added sugars should be 40 g based on USDA’s ‘‘Food Guide Pyramid’’ recommendations that Americans should limit their daily intake of added sugars to about ten teaspoons (40 g) for PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 11903 a 2,000 calorie healthful diet. The petition cited USDA Economic Research Service’s data that show that the per capita consumption of added sugars rose by 28 percent from 1983 to 1999 (Ref. 70). The petition also referred to evidence that added sugars may contribute to obesity and heart disease, and argued that it is impossible for consumers to determine how much sugar has been added to foods or how much added sugars are reasonable to consume because the Nutrition Facts label does not currently provide this information. Although the petition also requested that we amend our regulations to prescribe nutrient content claims and health claims related to ‘‘added sugars,’’ those requests are not considered within the scope of this proposed rule. We received another petition from CSPI on February 13, 2013 (hereafter referred to as ‘‘the 2013 CSPI petition’’), requesting that we revise the ‘‘sugars’’ line of the Nutrition Facts label to address ‘‘added sugars.’’ (Docket No. FDA–2013–P–0217) (https:// www.regulations.gov/ #!docketDetail;D=FDA-2013-P-0217). CSPI described ‘‘added sugars’’ as ‘‘various caloric sweeteners,’’ including sucrose, high-fructose corn syrup, corn sugar, invert sugar, corn syrup ‘‘and others.’’ We address CSPI’s request for an ‘‘added sugar’’ declaration in this proposed rulemaking. The data and information provided by the 2013 CSPI petition in regards to added sugar declaration does not change our current considerations or rationale for mandating added sugars on the label that are addressed in this document. Although CSPI included other requests in its petition, which generally relate to lowering levels of added sugars in foods, we do not address those requests in the context of this proposed rule because they are outside the scope of this proposed rule. iii. Public Comments. On June 26, 2000, we published a notice of availability of the 1999 CSPI petition in the Federal Register and requested comment (65 FR 39414). We received more than 2,700 comments from individuals, industry, academic institutions, advocacy groups, and health care groups. Several comments stated that added sugar declaration should be voluntary and not mandatory (Ref. 47). We did not ask any questions on added sugars in the 2007 ANPRM. However, we received comments that supported and others that opposed the declaration of added sugars on the Nutrition Facts label (Ref. 47). iv. FDA’s Considerations and Proposal. A key recommendation of the 2010 DGA is to reduce the intake of E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11904 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules calories from solid fats and added sugars. A high intake of calories from excess solid fat and added sugars can decrease the intake of nutrient-rich foods in the diet and can increase the overall caloric intake which could lead to weight management issues. As such, this key recommendation feeds into two overarching concepts of the intent of the Dietary Guidelines of maintaining calorie balance over time to achieve and sustain a healthy weight as well as supporting consumption of nutrientdense foods (Ref. 6). As discussed in this document, a declaration of added sugars on the Nutrition Facts label would assist consumers in maintaining healthy dietary practices by providing them with information necessary to meet the key recommendations to construct diets containing nutrientdense foods and reduce calorie intake from added sugars by reducing consumption of added sugars. The Nutrition Facts label includes the mandatory declaration of the fatty acids that are contained in solid fats from the DGA recommendation, in that saturated fatty acids and trans fatty acids are required to be declared on the Nutrition Facts label. Solid fats are solid at room temperature and contain a mixture of saturated and unsaturated fatty acids but tend to contain a high percentage of saturated or trans fatty acids. The disclosure of saturated fat and trans fat on the label not only provides information to consumers for managing their effects on CVD (see sections II.B. and II.C.) but also could provide a marker for foods that contain solid fats that are abundant in the diets of Americans and contribute significantly to excess calorie intake (Ref. 6). However, similar information about added sugars is not currently available on the Nutrition Facts label. Thus, we are proposing to require the declaration of added sugars on the Nutrition Facts label to provide consumers with information that is necessary to meet the dietary recommendation to reduce caloric intake from solid fats and added sugars. Added sugars contribute an average of 16 percent of the total calories in American diets (Ref. 6). According to NHANES, the major sources of added sugars in the diet in descending order are soda, energy and sports drinks, grain based desserts, sugar-sweetened fruit drinks, dairy-based desserts and candy. Most of these foods are not nutrientdense and may add calories to the diet without providing dietary fiber or essential vitamins and minerals (Ref. 6). The consumption levels of added sugars alone exceed the discretionary calorie recommendations of 5 to 15 percent of VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 calories from both solid fats and added sugars discussed in the 2010 DGA. Although foods containing solid fats and added sugars do not contribute to weight gain any more than another calorie source, they make up a significant percentage of the American diet and are a source of excess calories. The 2010 DGAC concluded that strong evidence shows that children who consume sugar-sweetened beverages have increased adiposity (increased body fat). The 2010 DGAC also concluded that there is a moderate body of evidence suggesting that greater consumption of sugar-sweetened beverages is associated with increased body weight in adults and that under isocaloric controlled conditions, added sugars, including sugar-sweetened beverages, are no more likely to cause weight gain in adults than any other source of energy. While the IOM FOP report did not review scientific data on added sugars, based on the 2010 DGA recommendation to reduce intake of calories from added sugars, it concluded that added sugars should be included in an FOP labeling system. In addition the IOM FOP committee recommended that the FOP symbol system should be integrated with the Nutrition Facts label so that the two are mutually reinforcing. The IOM DRI Macronutrient Report noted the difficulty, among some populations, of consuming adequate amounts of certain micronutrients when excessive amounts of added sugars are consumed. As the CSPI petition pointed out, other groups such as the American Heart Association (AHA), American Academy of Pediatrics, and World Health Organization (WHO) have recommended limiting added sugars consumption. None of these recommendations was based on an increased risk of obesity or heart disease. Both the AHA and American Academy of Pediatrics recommendations point out that added sugars intake is associated with a greater intake of calories and a lower intake of essential nutrients, whereas the 1990 WHO recommendation for decreasing added sugars is based on dental caries and that excessive consumption of these sugars can displace nutrient-containing foods in the diet (Refs. 71 to 73). While these groups are not recognized as U.S. consensus groups by FDA, these recommendations support our proposal to require the mandatory declaration of added sugars so that consumers can achieve a dietary pattern that is nutrient-dense and that does not exceed caloric needs from added sugars, PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 consistent with the 2010 DGA recommendations. Further, we consider it necessary to require a declaration of added sugars for all foods for which a Nutrition Facts label is required. Using the current label, consumers cannot identify or compare the amounts of added sugars to enable them to follow the recommendation of the 2010 DGA. We are proposing mandatory declaration of added sugars on all foods because of (1) the variability in ingredients used, (2) the need for consumers to have a consistent basis on which to compare products, (3) the need for consumers to identify the presence or absence of added sugars, and (4) when added sugars are present, the need for consumers to identify the amount of added sugars added to the food. The mandatory declaration of added sugars may also prompt product reformulation of foods high in added sugars like what was seen when trans fat labeling was mandated (Ref. 58). We understand that our rationale to support an added sugars mandatory declaration in labeling is different from our rationale to support other mandatory nutrients to date which, consistent with the factors we describe in section I.C., generally relate to the intake of a nutrient and risk of chronic disease, a health-related condition, or a physiological endpoint. U.S. consensus reports have determined that inadequate evidence exists to support the direct contribution of added sugars to obesity or heart disease. Specifically, although it is recognized that sugar-sweetened beverages increase adiposity (body fat) in children (Ref. 30), neither the 2010 DGA nor the IOM macronutrient report concluded that added sugars consumption from all dietary sources, in itself, increases obesity. In fact, the 2010 DGA states that added sugars do not contribute to weight gain more than any other source of calories. The evidence submitted by CSPI supporting the contribution of added sugars to heart disease failed to show a direct association between added sugars consumption and heart disease risk. Rather, the evidence shows that the consumption of total carbohydrates (not added sugars, per se) is associated with an increase in serum triglyceride levels. Moreover, serum triglyceride level is not an endpoint that we recognize as a validated surrogate marker for CHD risk in our evidence-based review system for health claims (Ref. 74). Nevertheless, for the reasons explained previously that include providing consumers with the information necessary to follow the 2010 DGA recommendations to reduce the intake of calories from added sugars, E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules we tentatively conclude that the declaration of added sugars is required to assist consumers in maintaining healthy dietary practices. Additionally, in the absence of uniform added sugars declaration on the Nutrition Facts label, consumers would not be able to compare the added sugars content of foods, particularly those that contain both naturally occurring sugars and added sugars (e.g., yogurt and dairybased desserts). Contrary to what one comment stated, the added sugars declaration in the ingredient statement of a food label may not provide sufficient or quantitative information for consumers to be able to formulate diets consistent with the dietary recommendations. Sugars may be added to foods in the form of various ingredients, such as fruit juice concentrates, fructose, maltose, sucrose, and honey, and consumers may not realize that these ingredients are, in fact, forms of added sugars and would not be able to determine the quantities added. Thus, as pointed out in some comments, calorie declaration and ingredient listing do not provide enough information for consumers to determine the amount of calories derived from added sugars in the food. We acknowledge that some products may contain only added sugars and no naturally occurring sugars (e.g., soda) and that the amount shown in the total ‘‘sugars’’ declaration on the Nutrition Facts label for such products would be the amount of added sugars. In this case, however, some consumers may still not be able to determine the amount of added sugars because the term would not appear on the label at all. At this point in time, we cannot be certain that most consumers would understand that, in the absence of added sugars declaration, all sugars in these products are added sugars. Therefore, without the added sugars declaration, some consumers may perceive the amount of added sugars in the product differently and some perceived amounts may differ from the actual amount in the product. Food formulations may vary and consistency in the mandatory declaration of added sugars is important so that consumers are not confused. We recognize that small amounts of added sugars can increase the palatability of nutrient-dense foods, as suggested by a comment. The disclosure of added sugars on the label may allow consumers to plan and construct their diets to include small amounts of added sugars and still consume adequate amounts of necessary nutrients. Consumers may select from a variety of such nutrient-dense foods as part of their overall dietary pattern in a way to VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 reduce or minimize the caloric contribution of added sugars from such sources. The IOM FOP report noted that small amounts of added sugars would be appropriate for foods to earn FOP points in their recommended labeling scheme, which suggests that small amounts would be appropriate in a balanced diet (Ref. 29). We acknowledge that, if finalized, a requirement for declaration of added sugars on the Nutrition Facts label will need to be accompanied by consumer education on the role of added sugars, along with solid fats, and the use of the new information on the label in overall dietary planning. We will be conducting consumer studies that include questions regarding including added sugars on the Nutrition Facts label. We plan to use the results of these studies to help inform our future actions on this issue. We understand that there are currently no analytical methods that are able to distinguish between naturally occurring sugars and those sugars added to a food. However, we do not agree with comments that analytical limitations should preclude mandatory declaration of added sugars because there is an alternative method to assess compliance. The amount of added sugars declared on the label could be verified through means other than chemical analysis, such as through maintenance and review of records. The reliance on records for compliance purposes is not unique to added sugars as we have previously required that manufacturers provide records under certain circumstances to support statements made on food labels (for example, with respect to aeration to reduce fat and caloric content of foods (58 FR 2229 at 2271) and caloric content of new products with reduced digestibility (58 FR 2079 at 2111)). In addition, in sections II.D.5., II.J.2., and II.J.3., we are proposing to use records to determine compliance with declared values of dietary fiber, folate, and vitamin E, under certain specified circumstances. We continue to recognize the lack of a physiological distinction between added and naturally occurring sugars. While comments expressed concerns that declaration of added sugars could significantly under-represent the sugars content of many foods with a large quantity of naturally occurring sugars, we are not proposing to remove the total sugars declaration (see section II.D.2.) because there continues to be strong scientific evidence linking total sugars intake with dental caries. Therefore, the sugar content of foods with naturally occurring sugars would not be underreported. PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 11905 We also considered the appropriateness of voluntary declaration of added sugars, an approach supported by several comments. However, we are concerned that voluntary declaration of added sugars may not ensure that consumers have the information that will allow them to follow the current dietary recommendations. Added sugars declared voluntarily by manufacturers on some products, but not on others, either within a given product category or across different product categories, could be confusing to consumers, and would not provide consumers with the information they need to plan their dietary pattern to reduce consumption of calories from added sugars. In light of current dietary recommendations that advise Americans to reduce their intake of calories from added sugars, we consider that an added sugars declaration will help individuals identify foods that are nutrient-dense within calorie limits and aid in reducing excess discretionary calorie intake from added sugars. We tentatively conclude that the declaration of added sugars on the Nutrition Facts label is necessary to assist consumers to formulate diets consistent with current dietary recommendations and, thus, maintain healthy dietary practices. Therefore, proposed § 101.9(c)(6)(iii) would require the mandatory declaration of added sugars as an indented line item underneath the declaration of total sugars on the Nutrition Facts label. We invite comment on this issue. We also invite comment, including the submission of research on whether calories from added sugars should be declared on the Nutrition Facts label in lieu of a gram declaration of added sugars to aid consumers in maintaining healthy dietary practices. FDA regulations require that the statement ‘‘Not a significant source of ll’’ for calories from fat, saturated fat, trans fat, cholesterol, dietary fiber, sugars, and protein must be placed at the bottom of the table of nutrient values in the same type size, under the specific circumstances described for each nutrient in § 101.9(c). For sugars, the phrase ‘‘Not a significant source of sugars’’ must be placed at the bottom of the table of nutrient values if a statement of the sugars content is not required and, as a result, not declared. A statement of sugars content is not required for products that contain less than 1 gram of sugars in a serving if no claims are made about sweeteners, sugars, or sugar alcohol content (§ 101.9(c)(6)(ii)). Similar information on added sugars could also be useful to consumers who are trying to limit their E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11906 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules intake of added sugars. Therefore, proposed § 101.9(c)(6)(iii) would require that the phrase ‘‘Not a significant source of added sugars’’ be placed at the bottom of the table of nutrient values if a statement of the added sugars content is not required and, as a result, is not declared. We are also proposing that a statement of added sugars content would not be required for products that contain less than 1 gram of added sugars in a serving if no claims are made about sweeteners, sugars, or sugar alcohol content (proposed § 101.9(c)(6)(iii)). In addition, for total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugars, and sugar alcohol, when a serving of the food contains less than 1 gram of the nutrient, FDA regulations in § 101.9 permit the use the alternative statements ‘‘Contains less than 1 gram’’ or ‘‘less than 1 gram,’’ and if a serving of the food contains less than 0.5 grams of the nutrient, the content may be expressed as zero. Proposed § 101.9(c)(6)(iii) would provide for similar use of alternative statements, ‘‘Contains less than 1 gram’’ and ‘‘less than 1 gram’’ for added sugars. In addition, if the serving contains less than 0.5 g of added sugars, we are proposing to permit the content to be expressed as zero (proposed § 101.9(c)(6)(iii)). b. Proposed Definition—The term ‘‘added sugars’’ is not defined in FDA regulations. Given our tentative conclusion to require mandatory declaration of ‘‘added sugars’’ on the Nutrition Facts label, we are proposing to define added sugars. In proposed § 101.9(c)(6)(iii), we are proposing to define ‘‘added sugars’’ as sugars that are either added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), syrups, naturally occurring sugars that are isolated from a whole food and concentrated so that sugar is the primary component (e.g., fruit juice concentrates), and other caloric sweeteners. This would include single ingredient foods such as individually packaged table sugar. Sugar alcohols are not considered to be added sugars. Names for added sugars include: Brown sugar, corn sweetener, corn syrup, dextrose, fructose, fruit juice concentrates, glucose, high-fructose corn syrup, honey, invert sugar, lactose, maltose, malt sugar, molasses, raw sugar, turbinado, sugar, trehalose, and sucrose. This proposed definition of added sugars includes what CSPI described as ‘‘added sugars’’ in the 2013 CSPI petition. c. Daily Value—Given our proposal to require the declaration of added sugars, we also considered establishing a DRV VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 for added sugars. In its 1999 petition as well as in a published report (Ref. 75), CSPI recommended that FDA base a DV for ‘‘added sugars’’ on suggested limits of added sugars published in the 1992 USDA’s Food Guide Pyramid (Ref. 76). CSPI determined that a DRV for added sugars based on a 2,000 calorie diet would be 10 teaspoons or 40 g of added sugars. Overall, comments submitted in response to CSPI’s 1999 petition were in favor of this approach to setting a DRV for added sugars. Comments in response to the 2007 ANPRM also recommended establishing a DV for added sugars (Ref. 47). We reviewed scientific evidence and recommendations of consensus reports, and disagree with the petitioner and comments that there is currently a sound scientific basis for the establishment of a quantitative intake recommendation upon which a DRV could be derived. The IOM did not set a DRI, such as a UL, for added sugars (Ref. 68). The IOM suggested that no more than 25 percent of energy should be consumed from added sugars, but noted that a defined intake level at which inadequate micronutrient intakes occur could not be identified. The 2010 DGA did not provide a quantitative intake recommendation for added sugars intake but did provide a maximum intake level for solid fats and added sugars at 13 percent of calories for a 2,000 calorie diet based on food pattern modeling of the USDA Food Patterns and also described the ‘‘DASH’’ (Dietary Approaches to Stop Hypertension) eating plan which recommends 5 servings or less per week of sweets and added sugars for a 2,000 calorie diet (Ref. 6). The USDA Food Patterns, which provide recommended amounts of foods from each food group that individuals should consume in order to meet their nutrient needs within a specific calorie level, specify that the maximum amount of calories from solid fats and added sugars that can be consumed at the 2,000 calorie level while staying within calorie limits is 258 calories (Ref. 6). The solid fats and added sugars limit at each calorie level in the USDA Food Patterns is determined by calculation through food pattern modeling rather than on any biomarker of risk of disease or other public health endpoint. However, an exact amount of calories for added sugars is not detailed in either the USDA Food Patterns or ‘‘DASH’’ eating plans, as they represent templates that translate and integrate dietary recommendations, rather than specific quantitative intake recommendations (Ref. 6). Thus, we have no scientifically PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 supported quantitative intake recommendation for added sugars on which a DRV for added sugars can be derived. Therefore, we are not proposing a DRV for added sugars. Accordingly, the proposed rule, if finalized, would declare added sugars on the Nutrition Facts label only in absolute amounts (in g), similar to the declaration of total sugars. d. Compliance—As expressed in the preamble to the 1993 RDI/DRV final rule, we are not aware of an analytical method that is capable of distinguishing between added and intrinsically occurring sugars in a food product (58 FR 2206 at 2222). Thus, it is not technologically feasible for us to rely on an analytical method to determine compliance with the declaration of added sugars in foods that contain both added sugars and naturally occurring sugars. We recognize that enforcement of the mandatory declaration of added sugars content will require an alternative means of verifying compliance and are proposing in § 101.9(g)(10) to include records requirements related to the added sugars declaration in food. Similarly, in the other cases where there are not reliable and appropriate analytical methods that will allow us to verify the amount of a given nutrient in a food (dietary fiber, vitamin E (tocopherol), and folate), we are also proposing to require manufacturers make and keep certain records necessary to verify the amount of these nutrients present in a food (see proposed § 101.9(g)(10)). In the case of added sugars that are not subject to fermentation, when a mixture of naturally occurring and added sugars is present in the food, we are proposing that a manufacturer must make and keep written records of the amount of added sugars added to the food during the processing of the food, and if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient) to verify the amount of added sugars present in the food (§ 101.9(g)(10)(iv)). (See section II.N for more details about this requirement.) i. Reactions during processing. Sugars in some foods may undergo chemical changes mediated by chemical reactions from non-enzymatic browning (i.e., Maillard reactions and caramelization) and fermentation during food processing. During these reactions, some sugars are metabolized or otherwise transformed and converted into compounds that are no longer recognizable or detectable as sugars through conventional analytical methods (Ref. 77). We expect that the E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules amount of added sugars transformed during non-enzymatic browning reactions is insignificant relative to the initial levels of sugars (Ref. 78). Unlike browning reactions, fermentation is a process that typically involves the action of desirable microorganisms (e.g., yeasts and lactic acid bacteria) and enzymes to convert organic compounds, especially sugars and other carbohydrates, to simpler compounds such as carbon dioxide, lactic acid, and ethyl alcohol (Refs. 52 and 79). Typical foods that are subject to fermentation during manufacturing are breads, cheese, yogurt, vinegar, vegetables, meats, beer and wine. Some foods, such as sweetened, yeastleavened breads and wines that are processed through a fermentation step contain added sugars which will likely be consumed by the microorganisms during fermentation; other foods processed through a fermentation step contain added sugars that will likely not be consumed to a large extent, if at all, during fermentation, for example, yogurt sweetened with sucrose. In addition, many products processed through a fermentation step, such as cheese, do not contain added sugars to aid in fermentation or improve taste (Ref. 78). Therefore, we tentatively conclude that the amount of added sugars present in foods prior to undergoing fermentation, with the exception of yeast-leavened bakery products, wines with less than 7 percent alcohol by volume, and beers that do not meet the definition of a ‘‘malt beverage’’ as defined by the Federal Alcohol Administration Act (27 U.S.C. 211(a)(7)) with sugars added during the fermentation process, will not be significantly affected by virtue of the food having undergone fermentation. We do not have adequate information to assess the degradation of added sugars during fermentation for yeast-leavened bakery products, wine with less than 7 percent alcohol by volume, and beers that do not meet the definition of a malt beverage with sugars added before or during the fermentation process. (Ref. 78). We request comments, including available data and information, on our tentative conclusions with respect to added sugars in products that are subjected to non-enzymatic browning reactions and fermentation. We specifically request data on the amount of variability that occurs among various types of products where added sugars are transformed into other compounds as a result of chemical reactions during food processing. ii. Records required to assess compliance. For yeast-leavened bakery VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 products, wines with less than 7 percent alcohol by volume, and beers that do not meet the definition of a malt beverage with sugars added before and during the fermentation process, it is unclear to us whether, as with most fermented foods, the reduction in the amount of added sugars would be insignificant. In addition to the records we propose to require for added sugars in foods generally, under proposed § 101.9(g)(10), we recognize that there is a need to consider other types of records related to added sugars content for a yeast-leavened bakery product, wine with less than 7 percent alcohol by volume, or a beer that does not meet the definition of a malt beverage when sugars are added to the food before or during the fermentation process (e.g. the added sugars are present during fermentation and the amount may be reduced by the fermentation process). Because of the unique issues that may be associated with a yeast-leavened bakery product, wine with less than 7 percent alcohol by volume, or a beer that does not meet the definition of a malt beverage when added sugars are present during the fermentation process (Ref. 78), we are proposing a new subparagraph (§ 101.9(g)(10)(v)) to specifically address records requirements for these products. Some manufacturers of yeast-leavened bakery products, wine with less than 7 percent alcohol by volume, and beers that do not meet the definition of a malt beverage where sugar is added before or during the fermentation process would likely have more detailed information about the reduction in added sugars from the process for the products they manufacture. Thus, we anticipate that manufacturers of some of these foods that undergo fermentation would be able to determine the amount of added sugars in the finished food product. For example, manufacturers could choose to determine through laboratory analysis the amount of added sugars as well as naturally occurring sugars consumed in their product during the fermentation process. Other manufacturers that are unable to conduct additional laboratory analyses of their product may rely on a scientific document (e.g., journal article or reference book) showing the amount of added sugars typically consumed during fermentation in a specific food product (see proposed § 101.9(g)(10)(v)(A)). Manufacturers may use information gathered through additional analyses or from scientific references to adjust the amount of sugars added in processing to achieve the desired taste and organoleptic properties in the finished food product. PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 11907 We also recognize that some manufacturers of these foods may not be able to use scientific data and information to verify the amount of added sugars in the finished food product. We tentatively conclude that it is appropriate to include, as an alternative to the use of scientific data and information for such verification, proposed record requirements for the amount of added sugars added to these products before and during fermentation for the verification of the declaration of added sugars content (see proposed § 101.9(g)(10)(v)(B)). As with other products containing added sugars, the amount of sugars added before or during fermentation could be determined through information such as databases, recipes, formulations, or batch records. Therefore, we are proposing, in § 101.9(g)(10)(v), to require a manufacturer of yeast-leavened bakery products, wines with less than 7 percent alcohol by volume, and beers that do not meet the definition of a malt beverage with sugars added before and during the fermentation process to make and keep records of added sugars necessary to determine the amount of added sugars present in the finished food in one of two ways. The first would require the manufacturer to make and keep records of all relevant scientific data and information relied upon by the manufacturer that demonstrates the amount of added sugars in the food after fermentation and a narrative explaining why the data and information are sufficient to demonstrate the amount of added sugars declared in the finished food. When the manufacturer is relying upon scientific data and information from reference documents to determine the amount of added sugars in these finished food products, the information used must be specific to the type of fermented food manufactured. For example, if a manufacturer produces raisin bread, the reference that the manufacturer is relying upon would need to show the amount of sugars typically consumed in raisin bread that undergoes fermentation. The second would require the manufacturer to make and keep records of the amount of added sugars added to the food before and during the processing of the food, and, if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient). The records would need to be made available to FDA consistent with the proposed requirements in § 101.9(g)(11). It is likely that the actual amount of added sugars remaining in yeastleavened breads, wines with less than 7 E:\FR\FM\03MRP2.SGM 03MRP2 11908 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 percent alcohol by volume, and beers that do not meet the definition of a malt beverage after they undergo fermentation will be less than the amount added before processing. We are proposing in section II.N to allow for reasonable deficiencies of added sugars under labeled amounts that are acceptable within current good manufacturing practice in § 101.9(g)(6). Because the consumer is not generally harmed if the amount declared on the nutrition label is a reasonable overage of the actual amount as indicated by § 101.9(g)(6), when the manufacturer chooses, as the declaration, the amount of sugars added to these specific foods before fermentation, the we consider the actual amount of added sugars in the finished food product to be a reasonable deficiency under § 101.9(g)(6). In some cases of these specific fermented foods, when the amount of sugar added to a product before fermentation is declared, it will exceed the amount of total sugars in the finished food product determined through laboratory analysis. This is due to the fact that the amount of added sugars consumed during the fermentation process is not reflected in the declared amount. In such cases, the we tentatively conclude that it may be confusing to the consumer if the amount of added sugars declared exceeds the amount of total sugars declared on the Nutrition Facts label. Therefore, we are proposing in § 101.9(g)(10)(v)(B) that the amount of added sugars declared shall not exceed the amount of total sugars declared on the label. 4. Sugar Alcohols FDA regulations define sugar alcohols, in part, as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group (e.g., mannitol or sorbitol) (§ 101.9(c)(6)(iii)). a. Voluntary Declaration—FDA regulations permit the voluntary declaration of sugar alcohols on the Nutrition Facts label (§ 101.9(c)(6)(iii)). In 2005, we received a citizen petition from the Sugar Association (Docket No. 2005–P–0373) requesting, among other requests, mandatory declaration of sugar alcohols on the Nutrition Facts label (https://www.regulations.gov/ #!docketDetail;D=FDA-2005-P-0373). The petition stated that, without this information, consumers would be misinformed about important modifications to foods and cannot make informed decisions about their particular sensitivity to the potential effects of sugar alcohols on the body. In the 2007 ANPRM, we asked whether the declaration of sugar alcohols should continue to be voluntary or made VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 mandatory. We considered comments received (Ref. 47) as well as arguments presented by the petition. We tentatively conclude that declaration of sugar alcohols should continue to be voluntary. Although a quantitative intake recommendation for sugar alcohols is not available from relevant U.S. consensus reports, sugar alcohols have positive health effects when they replace sugars in the diet. For example, there is well-established evidence to indicate that replacing sugars in the diet with sugar alcohols reduces the risk of dental caries, including the evidence used to support the health claims authorized by FDA on sugar alcohols and dental caries (72 FR 52783 at 52785; § 101.80). Therefore, we tentatively conclude that sugar alcohols have public health significance and, in the absence of a quantitative intake recommendation, voluntary declaration is consistent with the factors we consider for when voluntary declaration is appropriate (section I.C.). Accordingly, we are proposing to continue to provide for the voluntary declaration of sugar alcohols (in § 101.9(c)(6)(iii) redesignated as § 101.9(c)(6)(iv)). We disagree with the petition that mandatory declaration of sugar alcohols is necessary to ensure that consumers are not misinformed about modifications to foods. Sugar alcohols that are added to food must be listed in the ingredients list on food labels and, therefore, consumers will be informed of their use in a product. We also disagree with the comment that supported mandatory declaration when there is at least 1 gram of sugar alcohols per serving due to gastrointestinal problems at such a level. As warranted, FDA regulations require specific labeling statements to accompany the use of certain sugar alcohols to provide information to consumers about any gastrointestinal effects. For example, in the case of mannitol and sorbitol, the statement ‘‘Excessive consumption may have a laxative effect,’’ is required on the label and labeling of a food whose reasonably foreseeable consumption may result in a daily ingestion of 20 g for mannitol (21 CFR 180.25) and 50 g for sorbitol (§ 184.1835 (21 CFR 184.1835)). b. Use of the Term ‘‘Sugar Alcohol’’— In 1995, we received a citizen petition submitted by the Calorie Control Council requesting the use of the term ‘‘polyols’’ in lieu of ‘‘sugar alcohols’’ (Docket No. FDA-1995-P-0142) (https:// www.regulations.gov/ #!docketDetail;D=FDA-1995-P-0142). The petition stated that ‘‘polyol’’ is a regulatory term used in other countries, PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 such as Canada and New Zealand. In addition, the petition cited a survey that showed that 78 percent of consumers surveyed thought that products with sugar alcohol contained some sugar even when labeled ‘‘sugar free’’ and 69 percent thought that the product contained some alcohol. We considered the petition as well as comments in response to the 2007 ANPRM (Ref. 80). We previously considered the use of ‘‘polyol’’ (a contraction of ‘‘polyalcohol’’) and determined that it could be potentially more confusing to consumers than the term ‘‘sugar alcohol.’’ However, we acknowledge that consumers also may not be familiar with the term ‘‘sugar alcohol.’’ Therefore, in § 101.9(c)(6)(iii), we allow for the use of the name of the specific sugar alcohol in lieu of ‘‘sugar alcohols,’’ provided that only one sugar alcohol is present in the food, since many of the sugar alcohols are listed as ingredients (e.g., sorbitol, mannitol, xylitol) and hence may be more recognizable for consumers (58 FR 2079 at 2100). We continue to support the term ‘‘sugar alcohols’’ rather than ‘‘polyols,’’ because ‘‘sugar alcohols’’ more accurately describes the group of substances encompassed in the definition in § 101.9(c)(6)(iii). ‘‘Polyols’’ includes non-carbohydrate polyalcohols, such as polyesters, whereas ‘‘sugar alcohols,’’ as defined by FDA, includes only carbohydrates. Accordingly, we are not proposing to change the term ‘‘sugar alcohols’’ when used on the Nutrition Facts label, as specified in § 101.9(c)(6)(iii) redesignated as § 101.9(c)(6)(iv). c. DRV—FDA regulations do not provide a DRV for total sugar alcohols or for individual sugar alcohols. A quantitative reference intake recommendation for sugar alcohols is not available from current consensus reports and we have no basis on which to consider setting an appropriate DRV. Therefore, we are not proposing to set a DRV for sugar alcohols. d. Caloric Value—The caloric value for carbohydrates, other than insoluble fiber, is 4 kcal/g (§ 101.9(c)(1)(i)(C)). Sugar alcohols have been shown to have a caloric value lower than 4 kcal/g (Refs. 81 and 82). The 2007 ANPRM asked for comment on (1) how the energy contribution of sugar alcohols should be represented on the label since energy values vary, and (2) what analytical methods could be used to determine the energy contribution of sugar alcohols. We considered comments received (Ref. 47). We also considered relevant caloric values recommended by the Life Sciences Research Office (LSRO) that E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules were determined by various methods, including studies conducted in animals and human subjects, and based on the amount of energy metabolized or net energy values (Refs. 81 and 82). LSRO expert panel reports provided the following caloric values for individual sugar alcohols: Isomalt (2.0 kcal/g), lactitol (2.0 kcal/g), xylitol (2.4 kcal/g), maltitol (2.1 kcal/g), sorbitol (2.6 kcal/ g), hydrogenated starch hydrolysates (3.0 kcal/g), and mannitol (1.6 kcal/g). We support the use of the LSRO caloric values for individual sugar alcohols. The LSRO reports used appropriate methods and study design criteria for measuring caloric value, and noted that human data were preferred and that animal data should be viewed as supplemental information. We do not have any data that would question the caloric values determined by the LSRO reports for the specified sugar alcohols. We did not identify any human studies published since the release of the LSRO reports that demonstrate that a different caloric value for any of these sugar alcohols would be more appropriate. Therefore, we are proposing to amend § 101.9(c)(1)(i)(F) to establish the following general factors for caloric values of sugar alcohols, using the values recommended by LSRO: Isomalt—2.0 kcal/g, lactitol—2.0 kcal/g, xylitol—2.4 kcal/g, maltitol—2.1 kcal/g, sorbitol—2.6 kcal/g, hydrogenated starch hydrolysates—3.0 kcal/g, and mannitol—1.6 kcal/g. Accordingly, we are also proposing to amend § 101.9(c)(1)(i)(C) such that the 4 kcal/g is not applied to sugar alcohols. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 5. Dietary Fiber a. Dietary Fiber i. Definition. FDA regulations do not establish a definition for dietary fiber. There is no specific chemical definition for dietary fiber. Because of the difficulties in accurately isolating the set of fibers relevant to health, in 2001, the IOM established a panel to develop a new definition of dietary fiber (IOM Panel on the Definition of Dietary Fiber or IOM Panel). Subsequently, the IOM then issued a report defining ‘‘total fiber’’ as the sum of ‘‘dietary fiber’’ and ‘‘added fiber,’’ where ‘‘dietary fiber’’ consists of non-digestible carbohydrates and lignin that are intrinsic and intact in plants, and ‘‘added fiber’’ (referred to as ‘‘functional fiber’’ in the IOM Macronutrient Report) consists of isolated, non-digestible carbohydrates that have beneficial physiological effects in humans (Ref. 24). The IOM’s definitions of ‘‘dietary fiber’’ and ‘‘total fiber’’ only include those fibers that are considered to have health benefits. The VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 2007 ANPRM asked for public comment on whether the IOM dietary or functional fiber definitions should become the FDA definition for dietary fiber. We also asked whether it should develop criteria for identifying fibers that demonstrate a physiological benefit, and, if so, what those criteria should be. We received several comments (Ref. 47). We considered IOM recommendations, comments received, and relevant international guidelines. The Codex Alimentarius Commission adopted the following definition of dietary fiber in 2010 (Ref. 67): ‘‘Dietary fibre means carbohydrate polymers 1 with ten or more monomeric units,2 which are not hydrolysed by the endogenous enzymes in the small intestine of humans and belong to the following categories: • Edible carbohydrate polymers naturally occurring in the food as consumed, • Carbohydrate polymers, which have been obtained from food raw material by physical, enzymatic or chemical means and which have been shown to have a physiological effect of benefit to health as demonstrated by generally accepted scientific evidence to competent authorities, and • Synthetic carbohydrate polymers which have been shown to have a physiological effect of benefit to health as demonstrated by generally accepted scientific evidence to competent authorities. As with the IOM definition of ‘‘total fiber,’’ the 2010 Codex definition for ‘‘dietary fiber’’ includes naturally occurring fibers and only those nondigestible carbohydrates added to food that have a physiological effect that is beneficial to human health. Dietary fiber represents a heterogeneous group of compounds that vary in their carbohydrate composition, linkages between carbohydrates, and molecular weight. As stated previously, there is no specific chemical definition for dietary fiber. Therefore, considering the IOM and Codex definitions and comments received, as well as the role of the dietary fiber declaration on the Nutrition Facts label, we tentatively conclude that a regulatory definition for dietary fiber should be one that emphasizes its physiological effect that 1 ‘‘When derived from a plant origin, dietary fibre may include fractions of lignin and/or other compounds associated with polysaccharides in the plant cell walls. These compounds also may be measured by certain analytical method(s) for dietary fibre. However, such compounds are not included in the definition of dietary fibre if extracted and reintroduced into a food.’’ (Ref. 67). 2 ‘‘Decision on whether to include carbohydrates from 3 to 9 monomeric units should be left to national authorities.’’ (Ref. 67). PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 11909 is beneficial to human health. The declaration of dietary fiber that accurately reflects the amount of fiber that provides a physiological effect that is beneficial to human health would assist consumers in maintaining healthy dietary practices. We are proposing a single definition for dietary fiber that is equivalent to the IOM’s definition for ‘‘total fiber,’’ rather than IOM’s separate definitions of ‘‘dietary fiber’’ and ‘‘functional fiber.’’ Because both ‘‘dietary fiber’’ and ‘‘functional fiber’’ as defined by IOM are considered to have beneficial health effects, we tentatively conclude that there is little benefit for consumers in distinguishing between these two types of fiber on the Nutrition Facts label. In addition, the IOM itself recognized analytical limitations in distinguishing between ‘‘dietary fiber’’ and ‘‘functional fiber’’ and noted that the labeling of ‘‘total fiber’’ would be more practical than labeling ‘‘dietary fiber’’ and ‘‘functional fiber’’ separately (Ref. 24). The Codex definition includes a minimum degree of polymerization (DP) for a carbohydrate of 10, and it also provides that the inclusion of nondigestible carbohydrates with 3 to 9 monomeric units should be left to national authorities. The IOM’s definition for ‘‘total fiber’’ includes those non-digestible carbohydrates of 3 to 9 DP (Ref. 24). Because we seek to include in our definition non-digestible carbohydrates with physiological effects that are beneficial to human health, regardless of size, we are proposing to adopt a definition for total fiber that includes a DP of ≥ 3, consistent with the IOM’s definition. Therefore, we are proposing to amend § 101.9(c)(6)(i) to include the following definition for dietary fiber: (1) Nondigestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants; (2) isolated and synthetic non-digestible carbohydrates (with 3 or more monomeric units) that FDA has granted be included in the definition of dietary fiber, in response to a petition submitted to FDA under § 10.30 (21 CFR 10.30) demonstrating that such carbohydrates have a physiological effect(s) that is beneficial to human health; or (3) isolated and synthetic non-digestible carbohydrates (with 3 or more monomeric units) that are the subject of an authorized health claim. We invite comment on the proposed definition of dietary fiber. As proposed, under provisions 2 and 3, manufacturers would be required to provide evidence to FDA to demonstrate E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11910 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules the physiological effects that are beneficial to human health, of isolated and synthetic non-digestible carbohydrates added to food, and FDA would have to grant a petition or authorize a health claim before they can be considered as ‘‘dietary fiber’’ for declaration on the Nutrition Facts label. Manufacturers would use the citizen petition process in § 10.30 or, in case of a related health claim, the health claims petition process in § 101.70. We intend to issue guidance to industry on submissions to demonstrate physiological effects that are beneficial to human health. Under these proposed provisions, both b-glucan soluble fiber (§ 101.81(c)(2)(ii)(A)) and barley b-fiber (§ 101.81(c)(2)(ii)(A)(6)) that are added to foods would meet the definition of dietary fiber and, therefore, would be included in the amount of dietary fiber declared on the Nutrition Facts label. We are proposing to list isolated and synthetic non-digestible carbohydrates that have been determined by FDA to have a physiological effect that is beneficial to human health, in § 101.9(c)(6)(i). Accordingly, we are proposing to amend § 101.9(c)(6)(i) to list b-glucan soluble fiber and barley bfiber (as these substances are described in § 101.81(c)(2)(ii)(A) and (c)(2)(ii)(A)(6), respectively) as isolated and synthetic non-digestible carbohydrates that have been determined by FDA to have a physiological effect that is beneficial to human health and, therefore, must be included in the declaration of dietary fiber. Under this process, we would amend § 101.9(c)(6)(i) to list any additional isolated and synthetic nondigestible carbohydrates that FDA determines have a physiological effect that is beneficial to human health, through either the citizen petition process or the health claims petition process. ii. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act specifies, in part, that for each serving size or other unit of measure of a food, the amount of dietary fiber must be provided. Accordingly, FDA regulations require the declaration of dietary fiber on the Nutrition Facts label, as provided in § 101.9(c)(6)(i). We did not ask any questions about the mandatory labeling of dietary fiber in the 2007 ANPRM, and we received no comments on this subject. Dietary fiber is not an essential nutrient. However, it has physiological effects that are beneficial to human health, such as attenuation of postprandial blood glucose concentrations, attenuation of blood cholesterol VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 concentrations, and improved laxation (Ref. 66). The IOM DRI report noted that consumption of certain dietary fibers, particularly those that are poorly fermented (i.e., insoluble fiber), improve fecal bulk and laxation and ameliorate constipation (Ref. 66). In addition, soluble fiber plays a beneficial role in reducing the risk of heart disease (Ref. 66). ‘‘Dietary fiber’’ is identified as a nutrient of public health concern in the 2010 DGA. The 2010 DGA also emphasized the consumption of whole grains, in part, because they are a source of dietary fiber, noting that choosing whole grains that are higher in dietary fiber has health benefits in addition to meeting nutrient needs (Ref. 6). Given the health benefits of dietary fiber, we have no basis to conclude that the declaration of dietary fiber is no longer necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing to change our current requirement for the mandatory declaration of dietary fiber in § 101.9(6)(i). With respect to the term used to declare dietary fiber content on the Nutrition Facts label, we considered comments received in response to the 2007 ANPRM (Ref. 47). The term ‘‘dietary fiber’’ has been listed on the Nutrition Facts label since 1993. One survey pointed out by comments suggests that both ‘‘fiber’’ and ‘‘dietary fiber’’ are similarly acceptable by consumers (Ref. 47). Alternative terms such as ‘‘natural fiber’’ or ‘‘isolated fiber’’ would not be appropriate to declare all dietary fiber given that we are proposing a definition of dietary fiber that includes both natural fiber and fiber that is added to food. Although the IOM used the term ‘‘total fiber,’’ there is no evidence to suggest that this term is preferable to the term ‘‘dietary fiber.’’ Therefore, we are not proposing to change the current requirement to declare dietary fiber using the term ‘‘dietary fiber,’’ as specified in § 101.9(f). However, we request comment on this issue, including consumer understanding of the term ‘‘dietary fiber’’ relative to other relevant terms. iii. Analytical methods. Per FDA regulations, compliance with the requirement for declaration of dietary fiber is determined using appropriate AOAC analytical methods (58 FR 2079 at 2113; § 101.9(g)(2)). In the 2007 ANPRM, we noted the IOM Panel’s consideration of analytical issues related to dietary fiber, and asked whether we should continue to use the AOAC International methods to determine the amount of dietary fiber and, if not, what other or additional methods should be used. PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 We reviewed comments (Ref. 47) received as well as current AOAC methods for dietary fiber and the various analytes measured by these methods in light of our proposed definition for dietary fiber. AOAC methods, such as AOAC 985.29, 991.43 and 994.13, measure soluble and insoluble polysaccharides, lignin, higher molecular weight non-digestible oligosaccharides (DP > 12), and some resistant starch, inulin and low molecular weight non-digestible oligosaccharides (DP < 10). These methods do not measure all nondigestible carbohydrates with a DP < 10. In contrast, newer methods (AOAC 2009.01 and AOAC 2011.25) measure all low molecular weight non-digestible carbohydrates (i.e., non-digestible oligosaccharides) in addition to the higher molecular weight non-digestible carbohydrates (Ref. 83). Thus, these newer, more inclusive AOAC methods would be more consistent with our proposed definition. However, there is no analytical method that can distinguish non-digestible carbohydrates that have a beneficial physiological effect from those that do not. We are proposing to amend § 101.9(c)(6)(i) to indicate that dietary fiber content may be determined by subtracting the amount of non-digestible carbohydrates added during processing that do not meet the definition of dietary fiber (in proposed § 101.9(c)(6)(i)) from the value obtained using AOAC 2009.01, AOAC 2011.25 or an equivalent AOAC method of analysis as given in the ‘‘Official Methods of Analysis of the AOAC International’’ 19th Edition. If a product contains only non-digestible carbohydrates that meet the proposed definition of dietary fiber, using AOAC 2009.01, AOAC 2011.25, or an equivalent method would be sufficient to quantify the dietary fiber content of a food. However, if the product contains both dietary fiber that is included in the proposed definition (e.g., naturally occurring fibers) and non-digestible carbohydrates not included in the definition (e.g., synthetic fibers without a physiological effect that is beneficial to human health), neither AOAC 2009.01 or AOAC 2011.25 nor an equivalent AOAC method would accurately quantify the dietary fiber that could be declared on the Nutrition Facts label, because the determination of fiber by these methods would include the non-digestible carbohydrates that do not meet the proposed definition of dietary fiber. To verify that the quantity of dietary fiber declared on the Nutrition Facts label includes only those fibers that E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules meet the regulatory definition of dietary fiber, when a food contains a mixture of non-digestible carbohydrates that meet the proposed dietary fiber definition and those that do not, we are proposing in § 101.9(c)(6) and (g)(10) to require manufacturers to make and keep written records to verify the amount of added non-digestible carbohydrates that do not meet the proposed definition of dietary fiber. See discussion in section II.N. Such records would provide information to verify that the amount of dietary fiber declared meets the proposed definition. The amount of non-digestible carbohydrate measured by AOAC 2009.01 or AOAC 2011.25 (or an equivalent AOAC method) minus the amount of added non-digestible carbohydrate that has not been determined by FDA to have a physiological effect that is beneficial to human health would reflect the amount of dietary fiber lawfully declared on the label. iv. DRV. The DRV for dietary fiber is 25g (§ 101.9(c)(9)). We did not ask specific questions in the 2007 ANPRM and received no comments on the DRV for dietary fiber. In 2002, the IOM set an AI of 14 g/1,000 kcal for ‘‘total fiber’’ (Ref. 66). The AI was primarily based on the intake level that was associated with the greatest reduction in the risk of CHD. We are proposing to define dietary fiber to include those fibers that have a physiological effect that is beneficial to human health (see section II.D.5.) and, as such, the AI for ‘‘total fiber’’ provides an appropriate basis for setting a DRV for dietary fiber declared on the Nutrition Facts label. Therefore, we are proposing to use 14 g/1,000 kcal as the basis for a DRV for dietary fiber. Using a reference calorie intake of 2,000 calories (see section II.A.3.), we are proposing to amend § 101.9(c)(9) to set a DRV of 28 g (14g/ 1,000 kcal × 2,000 kcal/d) for dietary fiber. b. Soluble and Insoluble Fiber— Dietary fibers can be classified as being soluble or insoluble. Soluble fibers, such as pectin and gums, dissolve in water and are digested by the bacteria in the large intestine. Insoluble fibers, such as cellulose and lignin, do not dissolve in water and are not digested by bacteria in the large intestine, adding bulk to the stool for improved laxation. i. Definition. Like dietary fiber, FDA regulations do not establish definitions for soluble or insoluble fiber. The 2007 ANPRM did not ask questions about definitions for soluble and insoluble fiber and we did not receive any comments about them. Because soluble and insoluble fibers are components of dietary fiber, we tentatively conclude VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 that soluble and insoluble fibers must meet the proposed definition of dietary fiber. Therefore, we are proposing in § 101.9(c)(6)(i)(A) and (c)(6)(i)(B) that soluble fiber and insoluble fiber, respectively, must meet the definition of dietary fiber in paragraph 101.9(c)(6)(i). ii. Voluntary declaration. FDA regulations permit, but do not require, the declaration of soluble fiber (§ 101.9(c)(6)(i)(A)) and insoluble fiber (§ 101.9(c)(6)(i)(B)) on the Nutrition Facts label. In the 2007 ANPRM, FDA asked whether the declaration of soluble and insoluble fiber should continue to be voluntary or made mandatory. We considered comments received (Ref. 47). While a quantitative intake recommendation is not available from relevant U.S. consensus reports, there is well-established evidence showing that soluble and insoluble fibers have distinct physiological effects that are beneficial to human health. For example, the IOM noted that the body of evidence indicates that nonfermentable fiber sources (often isolated as insoluble fiber) promote laxation, and improved laxation is an established physiological effect that is beneficial to human health (Ref. 66). Therefore, we tentatively conclude that soluble and insoluble fibers that meet the definition of dietary fiber have public health significance and, in the absence of quantitative intake recommendations, are consistent with the considerations for voluntary declaration explained in section I.C. Accordingly, we are proposing to continue to provide for the voluntary declaration of soluble and insoluble fibers, as specified in § 101.9(c)(6)(i)(A) and (B). With respect to the term used to declare dietary fiber content on the Nutrition Facts label, in 2001, the IOM Panel recommended that the terms ‘‘soluble’’ and ‘‘insoluble’’ fiber be phased out and replaced with relevant descriptors of the physicochemical properties of particular fibers (e.g., ‘‘viscous’’ or ‘‘fermentable’’ fiber to replace ‘‘soluble’’ fiber), as the characterization of the properties of various fibers becomes standardized (Ref. 24). In the 2007 ANPRM, we noted this recommendation and asked for public comment on whether the terms ‘‘soluble fiber’’ and ‘‘insoluble fiber’’ should be changed to ‘‘viscous’’ and ‘‘nonviscous’’ fiber. We considered the IOM recommendations as well as comments received (Ref. 47), and tentatively conclude that the terms ‘‘soluble fiber’’ and ‘‘insoluble fiber’’ are most appropriate for reasons discussed in this document. While the IOM recommended replacing ‘‘soluble fiber’’ PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 11911 and ‘‘insoluble fiber’’ with appropriate physicochemical terms as the characterization of the properties of various fibers becomes standardized, such standardization has not yet occurred. In addition, as the comments stated, viscosity does not predict fermentability (Ref. 47), which the IOM recognized is a physicochemical property that is linked to health benefits, and it is not known at what level of viscosity a fiber begins to have a physiological effect (Ref. 66). Moreover, there are no currently available scientifically valid methods that FDA could use to measure the amount of various fibers defined by their physicochemical properties in various food matrices, whereas scientifically valid methods to measure soluble and insoluble fiber are currently available. Therefore, we are not proposing any changes to the use of terms ‘‘soluble fiber’’ and ‘‘insoluble fiber’’ in the Nutrition Facts label. iii. Analytical methods. Per FDA regulations, compliance with any declaration of soluble or insoluble fibers is determined using appropriate AOAC analytical methods (§ 101.9(g)(2)). While there are a number of traditional AOAC methods available for measuring soluble fiber (e.g., AOAC 991.43 and 993.19) and insoluble fiber (e.g., AOAC 991.42 and 991.43), as is the case with dietary fiber, these methods cannot measure all non-digestible carbohydrates with a DP < 10. A newer method, AOAC 2011.25 (Ref. 83), can measure low molecular weight non-digestible carbohydrates, as well as separately measure soluble and insoluble non-digestible carbohydrates. However, as in the case of AOAC 2009.01, AOAC 2011.25 (Ref. 83) cannot distinguish soluble and insoluble nondigestible carbohydrates that have a physiological effect that is beneficial to human health from those that do not. We are proposing to amend § 101.9(c)(6)(i)(A) and (c)(6)(i)(B) to indicate that the soluble and insoluble non-digestible carbohydrate content may be calculated by first using AOAC 2011.25, or an equivalent AOAC method of analysis. If a food contains only nondigestible carbohydrates that meet the proposed definition of dietary fiber (e.g., contains naturally occurring fiber only), then AOAC 2011.25 or an equivalent AOAC method would measure the amount of soluble or insoluble fiber that can be declared on the Nutrition Facts label. If a food contains a mixture of non-digestible carbohydrates that do and do not meet the proposed dietary fiber definition, and the label of the food declares soluble or insoluble fiber content, we are proposing to amend § 101.9(c)(6)(i)(A) and (c)(6)(i)(B) to E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11912 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules require manufacturers to make and keep records to verify the amount of soluble or insoluble non-digestible carbohydrates that do not meet the proposed definition of dietary fiber that have been added to the food product during processing. (See discussion in section II.N.) iv. DRV. FDA regulations do not establish DRVs for soluble fiber or insoluble fiber. No DRIs were established for soluble or insoluble fiber during the IOM’s evaluation of a DRI for dietary fiber (Ref. 66), and we have no basis on which to derive an appropriate DRV. Therefore, we are not proposing to set a DRV for either soluble fiber or insoluble fiber. v. Caloric value. Per FDA regulations, the caloric content of a food may be calculated by, among other methods, using the general factors of 4, 4, and 9 kcal/g for protein, total carbohydrate less the amount of insoluble dietary fiber, and total fat, respectively (§ 101.9(c)(1)(i)(C)). Accordingly, soluble fiber, which is encompassed within ‘‘total carbohydrate,’’ is assigned a general factor of 4 kcal/g. We did not ask questions about the caloric value of dietary fibers in the 2007 ANPRM, but received a few comments on the caloric value of soluble fiber, including that 4 kcal/g for soluble fiber was too high and that we should consider 2 kcal/g, which is the caloric value identified by the United Nations Food and Agriculture Organization. We also received a citizen petition from the Calorie Control Council requesting that the caloric value of soluble fiber be no more than 2 kcal/ g (Docket No. FDA–1997–P–0232), based on the caloric contribution of energy yielding short chain fatty acids that are produced as a result of colonic fermentation of soluble fiber (https:// www.regulations.gov/ #!docketDetail;D=FDA-1997-P-0232). We agree with the comments and the petition supporting a caloric value of 2 kcal/g for soluble fiber. The anaerobic fermentation of soluble fibers in the colon has been shown to yield less energy than the 4 kcal/g obtained from aerobic metabolism of carbohydrates (Ref. 66). In addition, the absorption of energy yielding short chain fatty acids that are produced as a result of colonic fermentation of soluble fiber can vary, and data indicate that the average energy yield from soluble fibers is 1.5 to 2.5 kcal/g (Ref. 66). Therefore, we tentatively conclude that 2 kcal/g is a reasonable estimate of the caloric value of soluble non-digestible carbohydrates. Accordingly, we are proposing to amend § 101.9(c)(1)(i)(C) to establish a general factor of 2 kcal/g as the caloric value of soluble non-digestible carbohydrates. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Insoluble non-digestible carbohydrates are not included in the caloric calculation. We are also proposing a corresponding change to the introductory text in § 101.9(c)(1)(i)(C) to exclude non-digestible carbohydrate from total carbohydrate. FDA regulations require that the calories from total carbohydrate be calculated by using the general factor of 4 kcal/g of carbohydrate less the amount of insoluble dietary fiber (§ 101.9(c)(1)(i)(C)). We are proposing a new definition of dietary fiber (see section II.D.5.a.i.) that only allows for the declaration of dietary fibers that are added to foods that we have determined to have a physiological effect that is beneficial to human health, as ‘‘dietary fiber’’ on the Nutrition Facts label. Therefore, the proposed new definition of dietary fiber would exclude soluble and insoluble non-digestible carbohydrates that do not meet the proposed definition of dietary fiber. For the purposes of calculating calories from soluble non-digestible carbohydrate, the proposed factor of 2 kcal/g should apply to those soluble non-digestible carbohydrates that both do and do not meet the proposed definition of dietary fiber. To ensure that soluble nondigestible carbohydrates that do and do not meet the proposed definition of dietary fiber are excluded from total carbohydrate, such that a general factor of 2 kcal/g is applied to these nondigestible carbohydrates, we are proposing to amend § 101.9(c)(1)(i)(C) to require that calories from carbohydrate be calculated using a general factor of 4 kcal/g of total carbohydrate less the amount of non-digestible carbohydrates, which includes soluble and insoluble non-digestible carbohydrates that do and do not meet the definition of dietary fiber (see also section II.D.1.f.). 6. Other Carbohydrate FDA regulations define ‘‘other carbohydrate’’ as the difference between total carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, except that if sugar alcohol is not declared, ‘‘other carbohydrate’’ is defined as the difference between total carbohydrate and the sum of dietary fiber and sugars (§ 101.9(c)(6)(iv)). Examples of ‘‘other carbohydrate’’ include starch and oligosaccharides. A statement of the amount of ‘‘other carbohydrate’’ may be voluntarily declared on the Nutrition Facts label (§ 101.9(c)(6)(iv)). We did not ask questions about the labeling of ‘‘other carbohydrate’’ in the 2007 ANPRM, and we received no comments on this issue. However, we reconsidered the provision PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 for voluntary declaration of ‘‘Other carbohydrate’’ on the Nutrition Facts label based on the factors we consider for the mandatory and voluntary declaration discussed in section I.C. ‘‘Other carbohydrate’’ represents different types of carbohydrate, and, unlike sugars and dietary fiber, carbohydrates covered under this heterogeneous category have no shared physiological effects. Moreover, there is no well-established evidence to support the role of particular types of carbohydrate that fall within the ‘‘other carbohydrate’’ category, such as starch and oligosaccharides, in human health that is based on reliable and valid physiological or clinical endpoints. In addition, a quantitative intake recommendation for ‘‘Other carbohydrate’’ is not available from relevant consensus reports. Given the lack of public health significance or a quantitative intake recommendation for ‘‘other carbohydrate’’ as a category, consistent with the factors discussed in section I.C., we tentatively conclude that ‘‘Other carbohydrate’’ should no longer be permitted to be declared on the Nutrition Facts label. Therefore, we are proposing to remove current § 101.9(c)(6)(iv) to remove the provision that allows for the voluntary declaration of ‘‘Other carbohydrate’’ on the Nutrition Facts label. We are also proposing to make a corresponding revision to § 101.9(g)(4) and (g)(6) to remove references to ‘‘Other carbohydrates.’’ We invite comment on this issue, including any other data or factual information that we should consider in making a final determination. E. Protein 1. Mandatory and Voluntary Declaration Section 403(q)(1)(D) of the FD&C Act requires food labeling to bear nutrition information about protein. FDA regulations require the declaration of the amount of protein by weight, and provide for voluntary declaration of the percent DV for protein on the Nutrition Facts label (§ 101.9(c)(7)(i)). In response to the 2007 ANPRM, one comment supported the current approach, whereas another comment recommended that FDA require the labeling of the percent DV for protein. We considered current scientific evidence and comments received (Ref. 47). There is strong evidence based on valid physiological and clinical endpoints that protein is an essential nutrient that is necessary for human health and growth (Refs. 6 and 84). Therefore, we tentatively conclude that the declaration of protein content E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 remains necessary to assist consumers in maintaining healthy dietary practices. In addition, because protein intake in the U.S. population continues to be adequate when compared to the EAR absent a mandatory percent DV declaration (Ref. 85), we tentatively conclude that the declaration of protein as a percent DV should remain voluntary. Accordingly, we are not proposing any changes to the requirement for declaration of the quantitative amount of protein and the voluntary declaration of this amount as a percent DV on the Nutrition Facts label. 2. Analytical Methods Under § 101.9(c)(7), protein may be calculated on the basis of 6.25 times the nitrogen content of the food determined by the appropriate method of analysis as given in the Official Methods of Analysis of AOAC International, 15th ed. (1990), except when the official procedure for a specific food requires another factor. On December 21, 2000, we received a citizen petition from Protein Technologies International, Inc. (FDA–2000–P–0569), requesting that FDA amend the reference to the method used to calculate protein content found in § 101.9(c)(7) to read ‘‘the appropriate method of analysis as given in the Official Methods of Analysis of the AOAC International, 17th ed. (2000)’’ (https://www.regulations.gov/ #!docketDetail;D=FDA-2000-P-0569). The petition explained that the only approved method for use in human food in the 15th edition of the AOAC Official Methods of Analysis was the Kjeldahl method, which the petition stated involves the use of a mercury catalyst and, therefore, can be potentially harmful to humans and the environment. The petition asserted that the 17th edition of the AOAC Official Methods of Analysis recognized an alternative method, the Combustion method, also known as the Dumas method, to measure protein levels in some human foods and that we should permit its use for measuring protein content. We note that not all Kjeldahl methods included in the Official Methods of Analysis of the AOAC contain a mercury catalyst. Furthermore, the Kjeldahl method is a well-recognized, standard method for determination of protein content. In fact, it is the method cited for use in determination of protein digestibility in the ‘‘Protein Quality Evaluation, Report of the Joint FAO/ WHO Expert Consultation on Protein Quality Evaluation’’ (Ref. 86) that is incorporated by reference in § 101.9(c)(7)(ii). VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 As discussed in section II.N.2., we see a need to update the version of the Official Methods of Analysis of the AOAC International that we use for compliance purposes because newer, and sometimes better, analytical methods for many nutrients are included in versions of the methods that have been published since the 15th edition. We are, therefore, proposing to amend § 101.9(c)(7) to incorporate by reference the Official Methods of Analysis of the AOAC International, 19th ed. (2012) by removing ‘‘15th Ed. (1990)’’ and adding in its place ‘‘19th Ed. (2012).’’ The 19th edition is the most recent edition of the published AOAC methods, and includes both the Kjeldahl and the Combustion/Dumas methods. While the petition requested that the Agency amend § 101.9(c)(7) to incorporate the 17th edition of the AOAC methods, the 19th edition includes all of the methods for protein that were available in the 17th edition. Thus, the proposed action is consistent with the petition’s request. If a newer version of the Official Methods of Analysis of the AOAC International is published before publication of the final rule (assuming that this rulemaking does result in a final rule), we will consider, as appropriate, using the most recent version of the official AOAC methods in the final rule. To the extent that the methods for protein determination in the newer version differ from those provided in the 19th edition of the Official Methods of Analysis of the AOAC International, we will consider the need to seek additional public comment on the version of the AOAC Methods of Analysis of the AOAC International that is incorporated by reference in § 101.9(c)(7). 3. DRV The DRV for protein is 50 g (§ 101.9(c)(9)) and represents 10 percent of the 2,000 reference calorie intake level. The IOM Labeling Committee considered the IOM’s AMDR for protein (10 to 35 percent of energy intake for adults) and the AMDRs for fat and carbohydrates, and recommended setting the DV for protein based on the difference between total energy intake and the combined DVs for fat and carbohydrate (i.e., 100 percent of energy ¥ (DVfat + DVcarbohydrate). The 2007 ANPRM requested comment on whether the DV for protein should be based on (1) the approach recommended in the IOM Labeling Report; (2) the midpoint of the AMDR for protein (i.e., 22.5 percent); or (3) the EAR or RDA for protein. We received comments on each of these approaches (Ref. 47). Overall, PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 11913 comments supported the approach recommended in the IOM Labeling Report and maintaining the DV of 50 g/ d. We considered current scientific recommendations and agree with the comments that supported the continued use of the current approach. First, as explained in sections II.B. and II.D., we are not proposing to change the DRVs for fat (30 percent of calories from fat or 65 g) or carbohydrate (60 percent of calories from carbohydrate or 300 g). Applying the IOM Labeling Committee’s recommended approach, given our tentative conclusions on DRVs for fat and carbohydrates, that approach would result in no change to the DRV for protein, i.e., 10 percent (100 ¥ (60 + 30)) of calories from protein. Second, at 10 percent of caloric intake and using a reference energy intake of 2,000 calories, the DRV for protein is set at 50 g, which is relatively close to the IOM’s RDAs for men and women. The RDAs, which represent values that meet the needs of almost all (97 to 98 percent) individuals in a group, are set at 0.80 g/ kg for men and women who are 19 years and older, 0.85 g/kg for boys and girls 14 to 18 years of age, and 0.95 g/kg for boys and girls 4 to 13 years of age. Using reference weights established for age and gender groups, the resulting values are 56 g/d for males and 46 g/d for females who are 19 years of age or older (not including pregnant and lactating women), 52 g/d for males and 46 g/d for females between the ages of 14 through 18 years of age, 34 g/d for males and females between the ages of 9 and 13 years, and 19 g/d for males and females between the ages of 4 through 8 years. Thus, the DRV of 50 g for protein falls within the range of the RDAs calculated using reference weights. We do not consider the midpoint of the AMDR of 22.5 percent of energy intake to provide the most appropriate basis for a DRV for protein. We have no data to show that protein intakes are inadequate or that setting a higher DRV that is based on the midpoint of the AMDR is needed to prevent chronic diseases such as cardiovascular disease, obesity, and sarcopenia, as asserted by some comments (Ref. 47). The AMDR is a range of intakes for a particular energy source that is associated with reduced risk of chronic diseases while providing adequate intakes of essential nutrients (Ref. 20). The DRV of 10 percent of calories from protein falls within the AMDR. Thus, the DRV for protein falls within a range of protein consumption that is associated with a reduced risk of chronic disease while providing essential nutrients. E:\FR\FM\03MRP2.SGM 03MRP2 11914 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules Finally, we consider the use of the population-weighted EAR to be inappropriate. First, as the comments pointed out (Ref. 47), using the population-weighted EAR could lead to inadequate consumption in some subpopulations, such as males 19 years and older. In addition, the EARs for protein are expressed in terms of g/kg of body weight and based on consumption of good quality or ‘‘complete’’ protein. In order to calculate a DRV from the population-weighted EAR for the purposes of nutrition labeling, a reference body weight would have to be selected. Although we could use the EER predictive equations included in the IOM’s DRI macronutrient report (Ref. 50) to determine a reference body weight, these values may be inappropriate for the general U.S. population, which has a high percentage of overweight individuals. The IOM Labeling Report stated that deriving a label reference value for protein based on values from the EER predictive equations may not be appropriate for large segments of the North American population for the same reason (Ref. 25). Therefore, we tentatively conclude that the DRV for protein should continue to be based on 10 percent of calories. Accordingly, we are not proposing to change the DRV of 50 g for protein. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 F. Sodium 1. Mandatory Declaration FDA regulations require the declaration of sodium content on the Nutrition Facts label (§ 101.9(c)(4)). The 2007 ANPRM did not ask any questions about the mandatory declaration of sodium, but one comment that recommended the declaration of sodium should remain mandatory because the information can help consumers who are concerned about sodium and salt make appropriate food choices. Americans 4 years and older consume an average of approximately 3,650 mg sodium/d (NHANES 2003–2006), which is more than twice the amount required to meet their adequate intake (1,500 mg/ day for individuals 9 to 50 years old). Evidence continues to support the association between increased sodium consumption and increased blood pressure. In 2005, the IOM noted the direct relationship between sodium intake and increased blood pressure (Ref. 10). The 2010 DGAC and the 2013 IOM committee on Sodium Intake in Populations (Ref. 87) concluded that a strong body of evidence has been documented in adults that as sodium intake decreases, so does blood pressure (Ref. 30). We agree with the comment VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 that information about sodium content on the food label can help consumers make appropriate food choices. Therefore, we tentatively conclude that declaration of sodium should remain mandatory so consumers are provided information necessary to assist them in maintaining healthy dietary practices. Accordingly, we are not proposing to amend the current requirement for declaration of sodium in § 101.9(c)(4). 2. DRV a. Need to update the DRV—The DRV for sodium is 2,400 mg (§ 101.9(c)(9)). New scientific data and consensus reports on sodium published since the 1993 final rule (58 FR 2206 at 2224) highlight the need to reconsider the DRV. Recent key consensus reports and recommendations that FDA reviewed in reconsidering the DRV are as follows: i. IOM DRI Electrolytes Report. In 2005, the IOM established AIs and ULs for sodium (Ref. 10). The IOM found that data from dose-response trials for determining the daily requirement for sodium were insufficient to establish an EAR for sodium and, thus, an RDA could not be determined and an AI was set. The AIs for sodium are intake levels that meet or exceed the daily nutrient requirement, i.e., the recommended daily average intake levels that are needed to meet the sodium needs of most healthy and moderately active individuals, are 1,500 mg/d for individuals 9 to 50 years, 1,300 mg/d for individuals 51 to 70 years, and 1,200 mg/d for individuals older than 70 years and for children 4 to 8 years of age. AIs meet or exceed the intake levels required to meet nutrient needs and there is no benefit in consuming a nutrient in excess of its AI. Data available to the IOM showed that; (1) a carefully planned diet that provided an average of approximately 1,500 mg/d of sodium can meet recommended intakes of other nutrients; (2) 1,500 mg/d exceeds the levels of sodium intake that have been associated with effects of inadequacy, such as adverse effects on blood lipid concentrations and insulin resistance; and (3) 1,500 mg/d allows for sodium sweat losses in acclimatized individuals who are exposed to high temperatures or who become physically active. The AI does not apply to individuals who are highly active and workers who are exposed to heat stress that lose large volumes of sodium in sweat (Ref. 10). ULs are the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects to almost all individuals in the general population (Ref. 10). The major adverse and dose- PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 dependent effect of increased sodium intake is elevated blood pressure and the IOM noted that the relationship between sodium intake and blood pressure is continuous, making it difficult to set a precise UL because other environmental factors (weight, exercise, potassium intake, dietary pattern, and alcohol intake) and genetic factors also affect blood pressure. The ULs for sodium are 2,300 mg/d for all individuals ages 14 years and older, 1,900 mg/d for children 4 to 8 years old, and 2,200 mg/d for adolescents 9 to 13 years old. The UL is not intended to be a recommended intake level to encourage, but rather a level not to exceed. The IOM stated that the UL may be lower than 2,300 mg/d among certain groups who are at increased risk of the blood pressure-raising effects of increased sodium intake (e.g., older individuals, African Americans, and individuals with hypertension, chronic kidney disease, or diabetes), but insufficient data prevented IOM from defining a specific UL for these groups. Instead, the IOM set the same UL for these population groups as the one for the general population (i.e., 2,300 mg/ d), with the acknowledgment that the actual UL for this group may be lower. ii. IOM Report on the Strategies to Reduce Sodium Intake in the United States (IOM Sodium Strategies Report). After considering current trends in hypertension, sodium consumption, sodium content of the food supply, and existing strategies for sodium reduction, the IOM developed various strategies for reducing dietary sodium intake to levels recommended by the 2005 DGA. Among various recommendations to Government Agencies, food manufacturers, consumers, and other stakeholders, the IOM recommended that FDA adopt 1,500 mg as the DV for sodium, given that sodium is an essential nutrient and that, unlike in 1993 (58 FR 2206 at 2224), a reference value of adequacy is now available (i.e., the AI of 1,500 mg/d). iii. 2010 DGA. The 2005 DGA made a key recommendation for the general U.S. population to consume less than 2,300 mg/d of sodium and that individuals with hypertension, AfricanAmericans, and middle-aged and older adults should aim to consume no more than 1,500 mg/d of sodium (Ref. 36). In 2010, the DGAC evaluated evidence considered in the 2005 DGAC report in addition to new research on the relationship between sodium intake and blood pressure, focusing on the strength of the scientific evidence (Ref. 30). The 2010 DGAC report noted that 1,500 mg/ d should be the intake goal for the E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules general U.S. population. Further, the DGAC noted that, given the current U.S. marketplace and the resulting excessively high sodium intake, it will be challenging to achieve the lower level. The 2010 DGA, considering the 2010 DGAC conclusions, recommended a reduction in sodium intake to less than 2,300 mg/d and a further reduction to 1,500 mg/d among African Americans, individuals with hypertension, diabetes, or chronic kidney disease, and individuals ages 51 years or older. iv. IOM Report on Sodium Intake in Populations, Assessment of Evidence, 2013 (Ref. 87). The charge to the committee focused on literature published since 2003, therefore they reviewed literature between 2003 and 2012. The committee assessed the benefits and adverse outcomes (if any) of reducing sodium intake, particularly in the range of 1,500 to 2,300 mg/d, with an emphasis on the subgroups known to be at increased risk of the blood pressure-raising effects of increased sodium intake. Based on the review of studies that assessed cardiovascular events and mortality, the committee found that evidence from studies on direct health outcomes is inconsistent and insufficient to conclude that lowering sodium intakes below 2,300 mg/d will increase or decrease the risk of CVD outcomes or all-cause mortality in the general U.S. population. The committee also concluded that the evidence from direct health outcomes does not support recommendations for subgroups (people with diabetes, chronic kidney disease and pre-CVD) to lower their sodium intake to or even below 1,500 mg/d. No relevant evidence was found on health outcomes for the other population subgroups considered (i.e., African Americans and persons 51 years of age and older). b. CSPI petition—In 2005, we received a citizen petition from CSPI (2005 CSPI petition) requesting, among other sodium related issues, that FDA initiate rulemaking to reduce the DRV for sodium from 2,400 to 1,500 mg (Docket No. FDA–2005–P–0196 (formerly Docket No. 2005P–0450)) (https://www.regulations.gov/ #!docketDetail;D=FDA-2005-P-0196). Citing the 2005 DGA, the petition requested that FDA adopt a DV of 1,500 mg because that is the recommended maximum intake for roughly one-half of the adult population (i.e., people with hypertension, African-Americans, and middle-aged and older people). According to the petition, when recommended intake levels vary among population groups, FDA has typically been conservative, choosing a DV that is VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 most protective. In this proposed rule, we are responding to the petition’s request to reduce the DRV for sodium from 2,400 mg to 1,500 mg. The petition’s other requests are outside the scope of this rulemaking. c. Comments to 2007 ANPRM—In the 2007 ANPRM, we asked whether a new DV for sodium should be based on the UL or on the AI. We also asked whether the UL, were it to be used, should reflect the same approach (populationweighted or population-coverage) as the other DRIs. While a few comments supported retaining the current DRV of 2,400 mg, the majority of comments supported using the UL of 2,300 mg/d. Some other comments recommended setting a DV for sodium based on the AI of 1,500 mg/d. One comment urged that we adopt a tiered two-phase, step-down approach establishing an interim DRV of 2,000 mg in 2013 and a final revised DRV of 1,500 mg by 2020. See also (Ref. 47). d. Options Considered—When the Nutrition Facts label was developed in the early 1990s, no RDA or Estimated Safe and Adequate Daily Dietary Intake (ESADDI) levels were available for consideration. While the National Academy of Sciences established 500 mg/d as an estimated minimum requirement for healthy adults in 1989, the Agency relied on the recommendation from 1989 National Research Council Report Diet and Health: Implications for Reducing Chronic Disease Risk (Ref. 88) that provided a quantitative intake recommendation for salt, based on blood pressure, that was equivalent to 2,400 mg/d as a value that consumers should not exceed (58 FR 2206 at 2223, 2224). There is debate in the scientific community about the appropriate DV for sodium, taking into account its essentiality in relatively small amounts as well as its association with increased blood pressure at greater but varying levels of intake. Current recommendations recognize the benefits of reduced sodium intake in the general population, despite the heterogeneity among individuals in blood pressure responses to changes in sodium intake. Although several factors influence inter-individual variability in blood pressure responses to changes in dietary sodium, certain population groups have been reported to have a higher prevalence of salt sensitivity and are considered to be most at risk of sodium-related chronic disease. Salt sensitivity is the extent of change in blood pressure in response to a change in salt intake (Ref. 10). Salt sensitivity differs among subgroups of the population as well as among individuals PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 11915 within a subgroup. Subgroups that have been reported to have a high prevalence of salt sensitivity include individuals 51 years of age and older, African Americans, and individuals with hypertension, diabetes or chronic kidney disease. The 2010 DGA recommended that Americans reduce sodium intakes and also noted that these population subgroups, representing nearly half of the U.S. population, would benefit from even greater reductions in sodium intake than the general population. We have considered the challenges related to lowering the DV for sodium. For example, lowering the value on which the percent DV declaration is based would likely require efforts to ensure consumer understanding of the new percent DV declaration of sodium on the Nutrition Facts label. Based on recent dietary recommendations from consensus reports, currently available scientific evidence, comments in response to the 2007 ANPRM, and the 2005 CSPI petition, we considered the following options for updating the DV for sodium: (1) A DRV of 2,300 mg which reflects the UL for individuals aged 14 years and older; (2) An RDI of 1,500 mg which reflects the AI for individuals 9 to 50 years of age; and (3) Alternative approaches such as retaining a DRV of 2,400 mg, using a tiered approach or setting a DRV of 1,900 mg based on the UL for children 4 to 9 years of age. i. DRV of 2,300 mg/d. A DRV of 2,300 mg, which represents the UL for the majority of the population (persons 14 years of age and older), would be consistent with both the 2005 and 2010 DGA recommendations for sodium intake for the general population, as well as the 2013 IOM report on Sodium Intake in Populations. However, while a DRV of 2,300 mg would reflect the UL that is applicable to 88 percent of the U.S. population, including those who are susceptible to the blood pressureraising effects of sodium, it would exceed the UL for children 4 to 13 years of age which is 1,900mg/day for children 4–8 years of age and 2,000mg/ day for children 9–13 years of age. Setting the DV at 2,300 mg would classify the level as a DRV (rather than an RDI) and represent a reference intake level not to exceed. As such, it would be consistent with our current and proposed approach to using DRVs for other nutrients that should be limited in the diet and for which there are concerns of excess intake and risk of chronic disease or health-related conditions, for example, saturated fat E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11916 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules and cholesterol. The current and proposed DRVs for saturated fat and cholesterol are based on quantitative intake recommendations and underlying science that links the excess intake of these nutrients to specific adverse health effects (Ref. 6) (see sections II.B.2 and II.C.). We do note, however, that unlike saturated fat and cholesterol, sodium is an essential nutrient and, in the DRI Electrolytes report, the IOM established an AI for sodium. Results from the FDA Health and Diet Surveys have shown that consumers are aware that too much sodium is unhealthy (Refs. 39 to 41) and this awareness would suggest consumer acceptance of a DV based on a level not to exceed would be consistent with a DRV of 2,300 mg. Changing the DRV from 2,400 mg to 2,300 mg would likely result in less consumer confusion than changing the DRV to an RDI (a level to achieve) of 1,500 mg. Moreover, we have no data to suggest that lowering the reference value for the percent DV could result in consumer confusion, as claimed by a commenter (Ref. 47). ii. RDI of 1,500 mg. An RDI of 1,500 mg, based on the highest AI (i.e., among adults aged 19 to 50 years), would provide a daily average intake level that would reflect a low prevalence of inadequate sodium intakes of healthy and moderately active individuals while allowing for adequate intakes of other essential nutrients. As opposed to 2,300 mg, a DV of 1,500 mg would classify the level as an RDI representing a reference intake level to achieve. The 2005 IOM electrolytes report reviewed the evidence on low sodium intake and blood lipid concentrations and insulin resistance and noted that the AI of 1,500 mg/d exceeds the levels of sodium intake (typically less than 700 mg/d) that have been associated in some studies with adverse effects of blood lipid concentrations and insulin resistance (Ref. 10). The 2005 IOM electrolytes report reviewed the evidence for plasma renin and concluded that, in contrast to blood pressure, there is no consensus on the interpretation of plasma renin activity and its role in guiding therapy for high blood pressure (Ref. 10). Similar to plasma renin activity, the evidence for the role of sympathetic nerve activity and aldosterone is limited, and therefore neither is recognized as surrogate endpoints for CVD risk. Therefore, the AI of 1,500 mg/d exceeds the levels associated with low sodium intake and the previously discussed adverse effects. Using the population-coverage AI to set the RDI for sodium would be consistent with the proposed RDIs for other essential vitamins and minerals VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 for which AIs are established (e.g., vitamin K and choline) (see section II.I.). AIs are similar to RDAs in that they meet the needs of essentially all members of the population. Thus, using an AI as a quantitative intake recommendation for setting an RDI would be consistent with the proposed RDIs for other essential minerals that have AIs or RDAs, such as potassium and calcium. Traditionally, we have based the RDI for essential nutrients on quantitative intake recommendations that reflect the intake level necessary to meet the daily physiological needs for that nutrient. However, unlike the consumption of other vitamins and minerals, the majority of the population consumes sodium at levels that exceed the AI and the UL. This makes sodium unique in comparison to other vitamins and minerals for which people generally must strive to meet their daily needs. In addition, an RDI of 1,500 mg would be consistent with the 2010 IOM Sodium Strategies Report (Ref. 89). The IOM recommended that FDA base the DV for sodium on the AI of 1,500 mg/ d. First, the IOM stated that using the AI is consistent with the approach used for all other essential nutrients, where the DV is based on a reference value of adequacy rather than a reference value of safety. Second, although consumer data were not provided, the IOM strategies report argued that the use of the AI could better inform consumers of the actual contribution of sodium content to total sodium needs as an essential nutrient. Third, the IOM stated that adopting the AI would avoid misleading consumers into thinking that the sodium content of foods is more favorable than is actually the case. As such, from a public health perspective, the AI would provide a truer picture for the consumer of the contribution of the particular foods in assembling a healthful diet and is preferable for this purpose over the UL. Finally, the IOM opined that lowering the DV might act as an incentive for companies to reduce the sodium content of their foods because reducing the DV would result in a higher value of percent DV declared on the label if sodium content remained unchanged. The 2013 IOM Sodium Intake in Populations Committee concluded that the evidence was insufficient and inconsistent to recommend sodium intake levels below 2,300 mg/d for the general U.S. population based on the direct outcomes of CVD or all-cause mortality. While this recommendation does not address blood pressure or essentiality, it provides a level that the general population should seek to reduce their consumption to and PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 therefore is a consideration in our proposal. ANPRM comments pointed out challenges related to the feasibility of achieving a DV of 1,500 mg given the current marketplace and patterns of sodium consumption as well as changes in our nutrient content claims. If we were to adopt a DV of 1,500 mg, we anticipate that consumer education efforts would be needed to help consumers understand that the updated DV for sodium is a level to achieve rather than a level to consume less than and also that consuming in excess of this level would not be helpful. Additionally, the IOM set the AI, in part, at a level that would allow individuals to meet the recommended intakes of other nutrients if they adopted a carefully planned diet (Ref. 10) and consumer education efforts would need to communicate that 1,500 mg/d is a level that consumers should achieve rather than not exceed. While the Agency is considering ways to support the reduction of sodium in the food supply (76 FR 57050), significant changes in the food supply would be needed to achieve this goal. An updated DV for sodium based on 1,500 mg/d would perhaps necessitate revising other relevant regulatory requirements such as nutrient content claims, however such revisions would be less likely if the DV was updated to 2,300 mg. Previously, our decision to retain the sodium level for a ‘‘healthy’’ claim (§ 101.65) at 480 mg/reference amount customarily consumed (RACC) was based, in part, on technological barriers and product acceptance issues by consumers with the more restrictive level of 360 mg/RACC (70 FR 56828; September 29, 2005). We acknowledge concerns from comments that consumers may find it difficult to reduce dietary sodium levels to 1,500 mg/d. iii. Alternative approaches. A few comments suggested retaining 2,400 mg as the DRV for sodium. Retaining the DRV of 2,400 mg would exceed the UL for sodium for the entire population and there is no scientific evidence to support this level. Therefore, we do not consider 2,400 mg an appropriate DRV for sodium going forward. Also, based on ANPRM comments, we considered setting an interim DRV of 2,300 mg that would be further lowered to an RDI of 1,500 mg over time, providing companies a longer time to manufacture new foods or reformulate existing products to lower the sodium content. This approach would address concerns regarding the feasibility of individuals being able to meet an RDI of 1,500 mg given taste E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules preferences and sodium content of foods in the current marketplace. A tiered approach would help to gradually achieve the adequate intake level of 1,500 mg/d and would give manufacturers time to develop lower sodium products and for consumers to adjust their taste preferences. In addition, this approach would be consistent with the 2010 DGAC recommendations which suggested that reduction in sodium intakes to 1,500 mg/d among Americans should occur gradually over time to allow for adjustments in taste perceptions and to accompany changes in the sodium content of foods in the marketplace. We tentatively conclude that there is inadequate justification in consensus reports or arguments presented by comments (Ref. 47) to propose a tiered option. While levels of sodium intake may need to decrease gradually due to time needed for modifications to the sodium content of the food supply and consumer taste preferences, the DV for sodium should reflect an amount that will assist consumers in maintaining healthy dietary practices and in understanding the relative significance of the percent DV for a particular food in the context of the total daily diet. Moreover, DVs are based on scientific data supporting healthy dietary practices, not on the levels of a nutrient present in the food supply. We also considered using 1,900 mg/d, the UL for children 4 to 8 years of age, to set the DRV for sodium. Using the lowest UL for a population above 4 years of age is consistent with the population-coverage approach discussed in section II.1.5. In this case, it is a population-coverage approach that is protective for the age and gender subpopulation with the lowest relative UL, providing an intake level that is likely to pose no risk for any age or gender subpopulations. This is in contrast to the population-coverage approach, using the RDA or AI for other essential vitamins and minerals, to ensure that all age and gender subpopulations consume adequate amounts. However, a DRV of 1,900 mg is not aligned with any recommendations from consensus reports including the 2010 IOM Sodium Intake in Populations and was not suggested by any comments. e. Proposed DV—After considering the options discussed previously, we are proposing to set a DRV of 2,300 mg for sodium based on the UL for individuals ages 4 years of age and older (proposed § 101.9(c)(8)(iv)). First, a DRV of 2,300 mg would be consistent with the current sodium intake recommendations from consensus reports. Second, a DRV of VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 2,300 mg would be consistent with our current and proposed approach for other nutrients that should be limited in the diet and for which there are concerns of excess intake and risk of chronic disease and health-related conditions. Third, consumers are generally aware that too much sodium is not healthy and therefore the current consumer education messaging is consistent with a DRV of 2,300 mg. For the reasons explained previously, we tentatively conclude that a DRV of 2,300 mg for sodium is the most appropriate DV to assist consumers in maintaining healthy dietary practices and in understanding the relative significance of the sodium content within the context of a total daily diet. We invite comment on our consideration of various options and tentative conclusions presented in this section. In particular, we invite comment on: (1) The rationale for the proposed DRV of 2,300 mg of sodium; (2) whether an RDI of 1,500 mg would be more appropriate and why; and (3) whether any alternative approaches for selecting a DV for sodium and their public health bases for these approaches could be more appropriate and why. We are also interested in data and factual information on consumer understanding, interpretation, and use of the percent DV of sodium declared on food labels, including the understanding and potential influences of a DV that reflects an RDI based on an AI (an intake level to not consume less of), instead of a DRV based on a UL (an intake level not to exceed). G. Fluoride 1. Voluntary Declaration FDA regulations do not require or permit the declaration of fluoride on the Nutrition Facts label. In 1993, no U.S. consensus report had set a quantitative intake recommendation for fluoride. The 2007 ANPRM did not ask questions regarding the declaration of fluoride, but several comments supported the voluntary declaration of fluoride in mg or mcg amounts (Ref. 47). We are considering in this proposed rule whether fluoride should be required or permitted to be declared or whether the lack of provisions should be maintained. Fluoride is a nonessential nutrient, but there is well established evidence for the role of fluoride in reducing the risk of dental caries (Ref. 90). The IOM set a quantitative intake recommendation for fluoride based on its role in the reduction of risk of dental caries. Additionally, in 2006, a FDAMA notification for a health claim for PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 11917 fluoride in bottled water and dental caries was submitted to us under section 403(r)(2)(G) of the FD&C Act (Ref. 91). We did not object to the notification, indicating that we considered the evidence submitted to be sufficient for bottled water that meets the standards of identity and quality set forth in § 165.110 and the general requirements for health claims in § 101.14 to bear the claim (Ref. 91). Given that the positive health effects of fluoride are wellestablished, we tentatively conclude that declaration of fluoride content of a food can provide consumers with information to assist them in maintaining healthy dietary practices. However, as discussed in section II.G.2., a DRV cannot be established based on available quantitative intake recommendations. Thus, while fluoride is a nutrient with public health significance, an appropriate quantitative intake recommendation is not available for setting a DRV. Therefore, consistent with the factors we consider for declaration of nonstatutory nutrients discussed in section I.C., we are proposing to amend § 101.9(c)(5) to provide for voluntary declaration of fluoride. In addition, consistent with existing provisions for voluntary declaration of other nutrients, we are proposing that the declaration of fluoride would be mandatory when a claim about fluoride is made on the label or in labeling of foods. We are also proposing that when fluoride content is declared, it must be expressed as zero when a serving contains less than 0.1 mg of fluoride, to the nearest 0.1 mg increment when a serving contains less than or equal to 0.8 mg of fluoride, and the nearest 0.2 mg when a serving contains more than 0.8 mg of fluoride, consistent with how we have approached incremental values for other nutrients that are present in food in small amounts. 2. DRV FDA regulations do not provide an RDI or DRV for fluoride. The 2007 ANRPM discussed the DRIs for fluoride and asked whether we should establish a DV, given the availability of an AI. We considered current recommendations and scientific evidence as well as comments received (Ref. 47). In 1997, the IOM established DRIs (AIs and ULs) for fluoride (Ref. 90). The AI was set at 3 mg/d for women 19 years and older and 4 mg/d for men 19 years or older, to represent the intake value that reduces the occurrence of dental caries maximally in a group of individuals without causing unwanted side effects. AIs for children are 0.7 mg/ d (1 through 3 years), 1 mg/d (4 through E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11918 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 8 years), and 2 mg/d (9 through 13 years). In addition, the IOM set a UL for fluoride at 10 mg/d (0.1 mg/kg/d) for individuals older than 8 years, based on data that suggest that increased risk of developing early signs of skeletal fluorosis is associated with fluoride intakes greater than 10 mg/d. The UL for children 4 through 8 years is 2.2 mg/d based on risk of developing moderate enamel fluorosis. A recent report highlighted the potential adverse impact of excess fluoride intake (Ref. 92). These adverse impacts include moderate enamel fluorosis in children up to 8 years and skeletal fluorosis for individuals older than 8 years. In 2010, the Environmental Protection Agency (EPA) published a report on exposure of fluoride from various sources. This report provided a benchmark of no more than 0.08 mg/kg/ d of total fluoride intake to protect 99.5 percent of the population from severe dental fluorosis (Ref. 92). These benchmark levels (e.g., 1.68 mg/d for 4 to 7 years; 2.56 mg/d for 7 to 11 years; 4.08 mg/d for 11 to 14 years of age; and 5.6 mg/d for adults) are considerably lower than the ULs set by IOM in 1997. Thus, although the IOM set AIs for fluoride based on its role in reducing the risk of dental caries, more recent conclusions have highlighted concern about dental fluorosis associated with excess intakes. Because an RDI of 4 mg, using the population-coverage AI of 4 mg/d, exceeds or is equivalent to EPA’s benchmark values for children 4 to 14 years of age (1.68 to 4.08 mg/d), we are not proposing to set a DRV for fluoride. We considered concerns expressed by comments that a DRV should not be established because fluoride is not an essential nutrient. That fluoride is not essential is not, in itself, a justification for not establishing a DV for fluoride, because there is evidence demonstrating that dietary fluoride exposure is beneficial to public health owing to its ability to inhibit the development of dental caries in both children and adults (Ref. 90). However, we are not proposing to set a DRV for fluoride for other reasons as explained previously. We also do not consider that the DRV for fluoride should be set at zero because of concerns with adverse health effects and toxicity, as suggested by a comment. The IOM established an AI for fluoride based on risk reduction of dental caries. In addition, the ULs for children and adults that are set based on dental and skeletal fluorosis are greater than zero. Moreover, FDA regulations other than those related to nutrition labeling are intended to prevent excessive addition of fluoride in foods (§§ 165.110 and 170.45). VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 H. Essential Vitamins and Minerals of Public Health Significance In addition to sodium, a statutorily required nutrient, FDA regulations require the declaration of four essential vitamins and minerals, namely, vitamin A, vitamin C, calcium, and iron (§ 101.9(c)(8)(ii)). Vitamins and minerals that may be declared voluntarily are vitamin D, vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and potassium. In 1993, we identified vitamins A and C, calcium, and iron for mandatory declaration because we considered them to be nutrients of public health significance based on their inadequate dietary intakes among specific segments of the U.S. population and because they were identified as nutrients of potential public health significance in consensus reports (Refs. 88, 93 to 95) (58 FR 2079 at 2106). We continue to consider, consistent with the rationale put forth in 1993, that a vitamin or mineral’s public health significance should be the key factor in mandatory labeling (58 FR 2079 at 2106). In this section of the proposed rule, we discuss essential vitamins and minerals that are not expressly required to be declared by statute (referred to as ‘‘non-statutory’’). We are using our discretion, as described in this document, to propose mandatory declaration of certain non-statutory essential vitamins and minerals and voluntary declaration of others. Our tentative conclusions are based on an assessment of scientific data available for these nutrients, and consideration of the factors discussed in section I.C. (explained in this document). The RDIs that we are proposing for the declaration of vitamins and minerals are discussed in section II.I. We conducted an analysis of available data to determine the public health significance of non-statutory essential vitamins and minerals. The 2010 DGA identified nutrients of public health concern for the general U.S. population using criteria that are similar to factors that FDA considered in its own analysis (Ref. 6). The factors and the evaluation process used in our analysis, discussed in greater detail in Ref. 48, incorporate whether a DRI (i.e., RDA or AI) is based on a chronic disease risk (e.g., osteoporosis), a health-related condition (e.g., high blood pressure), or a nutrient deficiency with clinical significance (e.g., low iron storage leading to iron deficiency anemia) and whether PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 national survey data on nutrient intake, and/or, when available, biomarkers of nutrient status, provide evidence of inadequate intakes in the general healthy U.S. population (4 years of age and older). Furthermore, we consider whether a substantial prevalence exists in the general population of a chronic disease, health-related condition, or nutrient deficiency with clinical significance that was linked to the particular nutrient (e.g., potassium and risk of high blood pressure). To estimate the prevalence of nutrient adequacy or inadequacy in the U.S. population, we compared dietary intake data with the EAR or AI (whichever is established by the IOM for a particular nutrient) (Ref. 96) and, when reliable biomarkers of nutritional status were available, we compared the biomarker survey data with the data on adequacy of nutrient intake. The use of reliable status biomarker data provides assessments of nutrient status, independent of subjective factors associated with assessing nutrient intake, such as underreporting of food intake (Ref. 97 pp. 373, 513, 534, 602, and 606). In the 2007 ANPRM, we sought input on whether vitamin A, vitamin C, calcium, and iron are still considered to be of public health significance; and (2) whether there are other micronutrients of public health significance. We received several comments in response to these questions (Ref. 47). Based on our analysis of data, and considering the factors for mandatory and voluntary declaration discussed in section I.C. and the comments received, as discussed in this document, we are proposing to: (1) With respect to essential vitamins and minerals that are currently required to be declared, retain mandatory declaration of calcium and iron and provide for voluntary declaration of vitamins A and C; and (2) with respect to essential vitamins and minerals that are permitted to be declared, require the declaration of potassium and vitamin D and retain voluntary declaration of others. We discuss these proposed changes in this document. 1. Essential Vitamins and Minerals That Are Mandatory a. Calcium—Calcium content must be declared as a percent DV on the Nutrition Facts label (§ 101.9(c)(8)(ii)). In 1993, we required the declaration of calcium in nutrition labeling because: (1) There were a limited number of calcium-rich foods in the food supply; (2) calcium intakes in the United States were generally marginal; (3) adequate calcium intakes are needed to allow for E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules optimal bone mass development during childhood and young adulthood (55 FR 29487 at 29501); and (4) calcium was identified as a nutrient of public health significance in the 1990 IOM report (Ref. 95) and in other consensus reports (Refs. 88,93,94) (58 FR 2079 at 2106). In response to the 2007 ANPRM, many comments maintained that calcium is still considered a nutrient of public health significance, especially in bone development, and therefore should be retained as a mandatory nutrient on the Nutrition Facts label. Our analysis of NHANES (2003–2006) data shows that usual calcium intakes among the U.S. population continue to be low. About 49 percent of individuals ages 4 years and older have usual calcium intakes from conventional foods below the EAR, and 37 percent have intakes from both conventional foods plus supplements below the EAR (table 1). The 2010 DGA, too, recognized that low intakes of calcium are a public health concern for the general U.S. population (Ref. 6). We are unable to consider biomarker data because sensitive biochemical indicators reflecting calcium nutritional status are lacking. In setting DRIs for calcium, the IOM reviewed various endpoints (e.g., bone health, cancer, cardiovascular disease and diabetes), and bone health was the only endpoint with sufficient evidence to set a DRI (Ref. 22). Therefore, the IOM set age- and gender-specific DRIs based on the level of calcium intake consistent with bone accretion, achieving and maintaining bone calcium balance, minimizing the degree of bone loss, and reducing the risk of fracture in later stages of life (Ref. 22). The DRIs for calcium assume adequate intakes of vitamin D, a nutrient which is essential for promoting calcium absorption in the gut and for maintaining adequate calcium levels in the blood (Ref. 22). Building strong bones during childhood and adolescence can help prevent osteoporosis (the most common bone disease) later in life. Adequate calcium intakes are needed to allow for optimal bone mass development during childhood and young adulthood and to decrease rate of bone loss in adults (Ref. 22). An estimated 10 million Americans over 50 years of age have osteoporosis, while another 34 million are at risk and an estimated 1.5 million people suffer an osteoporotic-related fracture each year (Ref. 98). Furthermore, based on 2005–2006 NHANES data, about 5.3 million older men and women in the United States have osteoporosis at the femur neck, and 34.5 million more have osteopenia (low bone mass) in the femur neck (Ref. 99). VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 In addition, we independently reviewed data related to calcium intake and risk reduction of osteoporosis (§ 101.72) and authorized two health claims for this association, signifying calcium’s critical role in the reduction of risk of this chronic disease in the general healthy population. In view of the benefits of adequate calcium intake on bone health, reflected in the IOM’s DRIs, relatively low intakes of calcium, and the high prevalence of osteoporosis and osteopenia among the U.S. population, we tentatively conclude that calcium is a nutrient of public health significance and its declaration continues to be necessary to assist consumers in maintaining healthy dietary practices. Therefore, consistent with the factors we consider for mandatory declaration of non-statutory nutrients (see section I.C.), we are not proposing any changes to the current requirement for declaration of calcium on the Nutrition Facts label, as specified in § 101.9(c)(8)(ii). b. Iron—Iron must be declared as a percent DV on the Nutrition Facts label (§ 101.9(c)(8)(ii)). In 1993, we required the declaration of iron because (1) iron was identified as a nutrient of public health significance in a 1990 IOM report (Ref. 95) and in other consensus reports (Refs. 88,93,94); and (2) iron deficiency was a risk for certain segments of the U.S. population (i.e., young children, adolescents and women of childbearing age and pregnant women, especially those with low incomes) (58 FR 2079 at 2106). In response to the 2007 ANPRM, comments suggested retaining the mandatory declaration of iron because it is a nutrient of concern for women of childbearing age identified by the 2005 DGA (Ref. 36) and substantial numbers of adolescent females and women of childbearing age are iron deficient. Our analysis of NHANES (2003–2006) intake data shows that about 3.5 percent of the population ages 4 years and older (excluding pregnant and lactating women) have inadequate iron intakes from conventional foods (i.e., an intake below the EAR), and about 3.3 percent have inadequate iron intakes from conventional foods and dietary supplements (table 1). Subpopulation analyses of these NHANES 2003–2006 data shows that about 11.2 percent of women of childbearing age (12 to 49 years of age) continue to have intakes below the EAR, from conventional foods only and 10.4 percent continue to have intakes below the EAR from conventional foods plus dietary supplements (table 1). We also considered data for several status biomarkers related to iron nutrition, in addition to intake data. PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 11919 Serum ferritin is the major iron-storage compound and its concentration declines in the early stages of the development of iron deficiency (Refs. 100 and 101). Although low serum ferritin concentration is an indicator of early iron deficiency, it does not necessarily reflect the severity of iron depletion as it progresses (Ref. 101). In addition to determining serum ferritin, when relevant NHANES data were available, we also considered iron deficiency based on estimating stored body iron using the ferritin model and the body iron model (Ref. 102). Compared to the ferritin model, the body iron model is reported to produce lower estimates of prevalence of iron deficiency, better predict anemia, and be less affected by inflammation, although this model has some limitations (Ref. 103). Data from NHANES 1999–2002 for the general U.S. population showed a prevalence of iron deficiency, based on serum ferritin concentration (less than 15 nanograms (ng)/mL), body iron stores (based on the ferritin model), and iron deficiency anemia (defined as having iron deficiency and a low hemoglobin value) of 8.3, 6.5 and 1.9 percent, respectively (table 1). The IOM set age and gender specific DRIs (EARs and RDAs) based on factorial modeling, which included basal iron losses, menstrual losses, fetal requirements in pregnancy, increased requirements during growth for the expansion of blood volume, and/or increased tissue and storage iron (Ref. 100). Although the DRIs were not based directly on a chronic disease risk, iron deficiency and low iron stores over time will lead to iron deficiency anemia, an advanced stage of iron deficiency (Ref. 100). Anemia is associated with poor cognitive function, lower work performance, and low endurance in the general population; delayed psychomotor development in infants; and adverse pregnancy outcome (Ref. 100). Relevant biomarker data were available from NHANES 2003–2006 for certain subpopulations such as women of childbearing age (12 to 49 years old). Analyses of these data showed that about 14 percent of women of childbearing age (12 to 49 years) had serum ferritin concentration less than 15 ng/mL, while 10 and 14.5 percent of women had inadequate stores of body iron based on the body iron model or ferritin model, respectively (table 1). In addition, about 4.7 percent of these women had iron deficiency anemia. Based on these prevalence rates, the absolute numbers of individuals with iron deficiency in women of E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11920 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules childbearing age using 2010 projected U.S. Census data translate into 7.2 or 11.6 million women of childbearing age (12 to 49 years of age) with inadequate iron stores based on body iron model or ferritin model, respectively. About 3.76 million of these women are considered to have iron deficiency anemia. Thus, iron continues to be of public health significance among women of childbearing age and pregnant women, who account for 26 percent of the general U.S. population. Iron is also identified as a nutrient of public health significance in consensus reports. For example, Healthy People 2020 identified iron as a nutrient of public health significance among young children (1 to 4 years of age), women of childbearing age (12 to 49 years of age), and pregnant women, and announced an objective of a ten percent reduction in iron deficiency (using the body iron model) by the year 2020 (Ref. 104). Similarly, the 2010 DGA identified iron as a nutrient of concern among women capable of becoming pregnant and recommends choosing foods that supply heme iron, which is more readily absorbed by the body, additional iron sources, and enhancers of iron absorption such as vitamin C-rich foods (Ref. 6). Given the importance of the role of iron in public health and continued significance of inadequate intakes and deficiency among women of childbearing age, a significant portion of the general healthy population, we tentatively conclude that iron is a nutrient of public health significance and its declaration continues to be necessary to assist consumers in maintaining healthy dietary practices. Therefore, consistent with the factors used for mandatory declaration of nonstatutory nutrients (see section I.C.), we are not proposing any changes to the current requirement for declaration of iron on the Nutrition Facts label, as specified in § 101.9(c)(8)(ii). c. Vitamin A—Vitamin A must be declared as a percent DV on the Nutrition Facts label (§ 101.9(c)(8)(ii)). In 1993, we required the declaration of vitamin A in nutrition labeling because (1) it was found in a limited number of foods within the food supply, and (2) a 1990 IOM labeling report (Ref. 95) identified vitamin A as a nutrient of potential public health significance and stated that certain subpopulations (children under 5 years of age) were still at risk of deficiency for this vitamin (58 FR 2079 at 2106). In response to the 2007 ANPRM, several comments recommended retaining the mandatory declaration of vitamin A, with some noting that the 2005 DGA identified it VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 as a nutrient of concern (Ref. 36). Our analysis of intake data from NHANES 2003–2006 estimated that about 45 percent of the general U.S. population has usual vitamin A intakes from conventional foods below the EAR, and 34 percent have intakes from conventional foods plus dietary supplements below the EAR (table 1). However, the prevalence of vitamin A deficiency is not apparent. Only about 0.3 percent of those ages 6 years and older (excluding pregnant and lactating women) have a serum retinol concentration (a biomarker of vitamin A status) below 20 mcg/dL, a cutoff level that is used as an indicator of vitamin A deficiency (table 1) (Refs. 6 and 105). Because serum retinol levels are tightly regulated (homeostatically controlled) and do not always reflect total body status, using serum vitamin A for assessment of vitamin A status of individuals may not be useful (Ref. 101). However, the distribution of serum retinol levels in a population plus the prevalence of individuals with serum retinol levels below a given cutoff point may offer a better picture of the vitamin A status of a population (Ref. 101). Based on the analysis of distribution of serum retinol (NHANES 2003–2006), and the prevalence of those below the cutoff of 20 mcg/dL (0.3 percent), we estimated that the prevalence of vitamin A deficiency in the general U.S. population is not apparent. The IOM recognized that vitamin A deficiency is rarely seen in the healthy U.S. population (Ref. 105). Furthermore, the specific age and gender DRIs (EAR and RDA) set by the IOM were based on the amount of dietary vitamin A required to maintain adequate liver stores in well-nourished subjects, rather than on a specific adverse public health endpoint (Ref. 105). The DRIs represent an amount that will assure vitamin A reserves to cover periods of increased needs such as stress and low vitamin A intake (Ref. 105). In addition, the 2010 DGA does not include vitamin A among the list of nutrients of public health concern for the general U.S. population (Ref. 6). We also considered whether any changes are necessary to the provision for voluntary declaration of the portion of vitamin A activity derived from bcarotene, including whether its mandatory declaration is appropriate, as suggested by a comment. One comment noted that b-carotene intake, in particular, needs to be increased, but the comment provided no further explanation. The IOM did not set DRIs for b-carotene and other carotenoids due to limited scientific data (Ref. 18). The only known function of provitamin A PO 00000 Frm 00042 Fmt 4701 Sfmt 4702 carotenoids (i.e., a-carotene, b-carotene, and b-cryptoxanthin, which can be converted into vitamin A (retinol) in the body) in humans is to act as a source of vitamin A in the diet (Ref. 18). Furthermore, there is no clear evidence that suggests a protective association between dietary vitamin A or b-carotene and risk reduction of chronic diseases, such as cardiovascular disease and cancers (Ref. 105). In addition, evidence from large clinical trials suggests that bcarotene supplementation increases the incidence of lung cancer in a high-risk population (e.g., current or former smokers, asbestos workers) (Refs. 106 and 107). Further, the IOM introduced mcg of RAEs (retinol activity equivalents) as a new unit for expressing vitamin A activity to account for the reduced absorption for provitamin A carotenoids, including bcarotene (Ref. 105). This new unit, which would be the appropriate unit for declaring vitamin A on the Nutrition Facts label, takes into consideration vitamin A from all sources as well as the bioavailability of b-carotene and other provitamin A carotenoids (see section II.J.3.). Our analysis demonstrates that, even though vitamin A intakes appear to be low, vitamin A deficiency based on an assessment of vitamin A status is rare in the U.S. population. The IOM did not set a quantitative intake recommendation for vitamin A based on a public health endpoint. Thus, we tentatively conclude that vitamin A is no longer a nutrient of public health significance for the general U.S. population. Therefore, consistent with the factors for declaration of nonstatutory nutrients (see section I.C.), we are proposing to amend 101.9(c)(8)(ii) to no longer require, but to permit voluntary declaration of vitamin A on the Nutrition Facts label. However, vitamin A declaration would remain mandatory when vitamin A is added as a nutrient supplement or claims are made about it on the label or in labeling of foods. We are also not proposing to change the current provision for voluntary declaration of the percent of vitamin A that is present as b-carotene, as specified in § 101.9(c)(8)(vi). We request comment about whether there is an appropriate alternative analysis to application of the factors in section I.C. regarding the mandatory declaration of vitamin A. d. Vitamin C—Vitamin C must be declared as a percent DV on the Nutrition Facts label (§ 101.9(c)(8)(ii)). In 1993, we required the declaration of vitamin C because (1) a 1990 IOM labeling report (Ref. 95) identified vitamin C as a nutrient of potential E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules public health significance and stated that certain subpopulations were considered at risk of deficiency (such as elderly individuals on inadequate diets and infants fed cow’s milk exclusively) (58 FR 2079 at 2106), and (2) vitamin C was thought to play a role in promoting the intestinal absorption of non-heme iron, meaning that vitamin C in the same food as iron was considered to help prevent iron deficiency anemia, while excess vitamin C was considered to increase the risk of excessive iron absorption (55 FR 29487 at 29501, July 19, 1990). In response to the 2007 ANPRM about whether vitamin C is still a nutrient of public health significance, several comments recommended retaining the mandatory declaration of vitamin C, with some stating that vitamin C should be retained because it is a nutrient of concern identified by the 2005 DGA (Ref. 36), and is an enhancer of iron absorption for women of childbearing age. Our analysis of NHANES 2003–2006 estimated that about 35 percent of the general U.S. population has usual vitamin C intakes below the EAR, from conventional foods only and 27.5 percent have intakes below the EAR from conventional foods and supplements (table 1). While the prevalence of inadequate intake is high, prevalence of vitamin C deficiency is not apparent in the U.S. population. Only about 6 percent of the general population had serum vitamin C concentrations below 11.4 micromoles (mmol)/L, a cutoff level that is used as an indicator of vitamin C deficiency (Ref. 97 p.534; Ref. 101). The EAR for vitamin C is based on estimates of body pool or tissue levels of vitamin C that are required for antioxidant protection with minimal urinary loss, not on a public health endpoint (Ref. 18). The effects of vitamin C on risk of chronic diseases, such as cardiovascular disease or cancer, are not conclusive at this time (Ref. 18). We issued a letter of enforcement discretion on qualified health claims for vitamin C supplement intake and reduced risk of cancers, in which we concluded that there was no credible evidence on the risk reduction from vitamin C for most cancers (squamous cell cancer of the esophagus, colorectal, laryngeal, lung, oral cavity, pancreatic, pharyngeal, renal cell, and salivary gland cancers), and very limited evidence for an association between vitamin C supplement intake and gastric cancer (Ref. 108). The 2010 DGA does not include vitamin C among the list of nutrients of public health concern for the general U.S. population (Ref. 6). However, the 2010 DGA recommends that women VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 capable of becoming pregnant choose foods that are enhancers of iron absorption, such as vitamin C-rich foods (Ref. 6). While we agree that vitamin C enhances iron absorption, the prevalence of vitamin C deficiency in this subpopulation is not apparent. Only about 6 percent of this subgroup had serum vitamin C concentrations below 11.4 mmol/L (table 1). Based on the previous analysis and information, we tentatively conclude that while vitamin C intakes are low, vitamin C deficiency is uncommon and vitamin C is no longer a nutrient of public health significance for the general U.S. population. Therefore, consistent with the factors we consider for declaration of non-statutory nutrients (see section I.C.), we are proposing to amend § 101.9(c)(8)(ii) to no longer require, but to permit voluntary declaration of vitamin C on the Nutrition Facts label. However, vitamin C declaration would remain mandatory when vitamin C is added as a nutrient supplement or claims are made about it on the label or in labeling of foods. We request comment about whether there is an appropriate alternative analysis to the application of the factors in section I.C. regarding the mandatory declaration of vitamin C. 2. Essential Vitamins and Minerals That Are Voluntary a. Vitamin D—The declaration of vitamin D content in nutrition labeling is voluntary, unless vitamin D is added as a nutrient supplement or claims are made about it (§ 101.9(c)(8)(ii)). In 1993, we determined that vitamin D is not of particular public health significance in the United States because the human requirement for vitamin D could be met with sufficient exposure to sunlight and milk and other foods that were fortified with vitamin D. As a result, deficiencies in this vitamin were very rare (58 FR 2079 at 2107). In response to the 2007 ANPRM about what, if any, other micronutrients are of public health significance, several comments recommended vitamin D for mandatory declaration citing vitamin D inadequacy; relationship of vitamin D to chronic disease risk (e.g., rheumatoid arthritis, multiple sclerosis, and cancers, such as prostate, breast, lung, colon, and colorectal cancers); and the 2005 DGA, which identified vitamin D as a nutrient of concern for certain subpopulations (e.g., older adults, people with dark skin, and those exposed to insufficient ultraviolet band radiation) (Ref. 36). The IOM set age and gender specific DRIs (EAR and RDA) for vitamin D at a level that would achieve and maintain serum 25-hydroxy vitamin D (25(OH)D) PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 11921 concentrations above a defined level (40 to 50 nanomoles (nmol)/L) in order to maintain bone health (Ref. 22). Vitamin D has a role in bone health through calcium absorption and uptake by bones (Ref. 22). In addition, in 2008, we authorized a health claim for calcium and vitamin D intake and reduced risk of osteoporosis (§ 101.72), signifying vitamin D’s critical role in the risk reduction of this chronic disease. Vitamin D can be obtained through dietary sources, such as fish (e.g., salmon, rockfish, and tuna) and shellfish, which are the primary natural food sources of vitamin D. FDA affirmed certain uses of vitamin D food ingredients as Generally Recognized as Safe (GRAS) with specific limitations as listed in § 184.1950. Under § 184.1(b)(2), an ingredient affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use, and level of use. Any addition of the ingredient to food beyond the limitations set out in § 184.1950 requires either a food additive regulation or an amendment of § 184.1950. In this way, FDA can ensure that the vitamin D ingredients are added to food at safe levels. For detail on estimating dietary intake of substances in food, see FDA’s Guidance for Industry: Estimating Dietary Intake of Substances in Food (Ref. 109). Under FDA regulations (§§ 172.380 (21 CFR 172.380) and 184.1950), vitamin D can be added in specific amounts to foods such as breakfast cereals, grain products and pastas, fluid milks and milk products, and calcium-fortified juices. As for any vitamin or mineral, when vitamin D is added to a food, the total amount per serving must be declared in the Nutrition Facts label. In addition to dietary sources of vitamin D from conventional foods and dietary supplements, vitamin D is synthesized in the skin following direct exposure to the sun. Therefore, sunlight exposure is an important source of vitamin D. Serum concentration of 25(OH)D is widely considered as a biomarker of total vitamin D nutritional status and is recommended to be used for assessing vitamin D total exposure from all sources, including conventional foods, dietary supplements, synthesis from sun, and conversion of vitamin D from adipose stores in liver (Ref. 22). Our analysis of NHANES 2003–2006 data showed that about 18 percent of the U.S. population 4 years and older (excluding pregnant and lactating women) have serum 25(OH)D levels below the 40 nmol/L (a level set by IOM as equivalent to EAR), which indicates an increased risk of inadequate vitamin D exposure. E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11922 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules NHANES data collection normally does not include serum levels in the northern regions of the United States in the winter months, when one would expect a lower serum vitamin D level. Therefore, analysis of NHANES data may underestimate the prevalence of low serum vitamin D levels in the Unites States population. Analysis of NHANES 2005–2008 dietary data showed that, about 94 percent of the U.S. population have usual vitamin D intakes below the EAR from conventional foods only and 62 percent have intakes below the EAR from conventional foods and supplements (table 1). The IOM set the DRIs (e.g., EAR) assuming minimal sun exposure (Ref. 22). Furthermore, approximately 24 percent of the U.S. population ages 4 years and older have serum 25(OH)D concentrations between 30 and 50 nmol/L, levels that indicate risk for inadequacy according to the IOM and CDC (Refs. 22 and 101). Approximately 32 percent of the U.S. population have serum 25(OH)D levels below 50 nmol/L (a level set by IOM as equivalent to RDA and associated with optimal benefit for nearly all the population) (Ref. 22). Also, about 8 percent have serum 25(OH)D levels below IOM’s cutoff of 30 nmol/L and may be at increased risk of vitamin D deficiency. Vitamin D deficiency results in inadequate bone mineralization or demineralization of the skeleton including rickets, osteomalacia, and osteoporosis (Ref. 22). The 2010 DGA, too, highlighted vitamin D as a nutrient of concern for the U.S. population, in general, rather than for specific population groups alone (Ref. 6). We do not agree with some comments that suggested that vitamin D intake should be mandatory on the label because of its relationship to disease risk reduction, generally. The IOM did not set DRIs for vitamin D based on its protective effect against diseases, such as cancers, cardiovascular disease, and diabetes, because the scientific evidence does not support a role other than that associated with bone health (Ref. 22). In view of the benefits of adequate vitamin D intakes on bone health, reflected in the IOM’s DRIs, data indicating inadequate intakes, poor vitamin D status, and high prevalence of osteoporosis and osteopenia (discussed previously in the calcium section, (Refs. 98 and 99) among the general U.S. population, we tentatively conclude that vitamin D is a nutrient of ‘‘public health significance,’’ as described in section I.C., and its mandatory declaration is necessary to assist consumers in maintaining healthy dietary practices. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Therefore, consistent with the factors we consider for mandatory declaration of non-statutory nutrients (see section I.C.), we are proposing to amend § 101.9(c)(8)(ii) to require the mandatory declaration of vitamin D on the Nutrition Facts label. We request comment about whether there is an appropriate alternative analysis to the application of the factors in section I.C. regarding the mandatory declaration of vitamin D. b. Potassium—The declaration of potassium content is voluntary, except when a claim is made about it (§ 101.9(c)(5)). In 1993, potassium did not meet our considerations for inclusion as a mandatory element of nutrition labeling because no quantitative intake recommendations were available in national consensus reports (58 FR 2079 at 2095). In response to our question in the 2007 ANPRM about what, if any, other micronutrients are of public health significance, several comments supported mandatory declaration of potassium on the Nutrition Facts label because the 2005 DGA identified it as a nutrient of concern (Ref. 36). One comment also pointed out that scientific evidence from three meta-analyses of over 30 clinical trials shows that high potassium intake is associated with reduced blood pressure in nonhypertensive and hypertensive individuals (Refs. 110 to 112). Our analysis of data from NHANES 2003–2006 shows that the usual mean intakes of potassium from conventional foods only (2,644 mg/d) and from conventional foods plus dietary supplements (2,651 mg/d) are below the population-weighted AI of 4,622 mg/d. Where the mean usual intake is at or above the AI, we consider that there is probably a low prevalence of nutrient inadequacy in the population assessed. However, where the mean usual intake is below the AI, the population’s prevalence of inadequacy cannot be estimated (Ref. 96). Therefore, the likelihood of nutrient inadequacy cannot be estimated. Only about 1.9 percent of the general population has usual potassium intakes above the AI from conventional foods only and 2.4 percent has intakes above the AI from conventional foods plus dietary supplements (table 1), indicating that the adequacy of intakes is very low. In the absence of a sensitive biochemical indicator of potassium nutritional status, we could not consider biomarker data to inform the determination of prevalence of potassium deficiency. However, the IOM set age- and genderspecific AIs for potassium based on risk of chronic disease. The AI was set at a PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 level that would maintain blood pressure, reduce the adverse effects of sodium chloride intake on blood pressure, and reduce the risk of recurrent kidney stones (Ref. 21). According to the CDC, about one out of three U.S. adults has high blood pressure (Ref. 113). In 2000, a FDAMA notification for a health claim about potassium, blood pressure, and stroke was submitted to us under section 403(r)(2)(g) of the FD&C Act (Ref. 114). We did not object to the notification and this meant that manufacturers could include the following claim ‘‘Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke,’’ on the label or labeling of any food that meets the eligibility criteria described in the notification and meets the general requirements for health claims (§ 101.14(e)(6)). Thus, we recognize the importance of potassium in the risk reduction of these chronic diseases. The 2010 DGA also concluded that potassium is a nutrient of concern for the general U.S. population (Ref. 6). In view of the benefits of adequate potassium intake in lowering blood pressure, reflected in IOM’s DRIs, and data indicating low likelihood of potassium adequacy and high prevalence of hypertension among the general population, we tentatively conclude that potassium is a nutrient of public health significance for the general U.S. population and its declaration is necessary to assist consumers in maintaining healthy dietary practices. Therefore, consistent with the factors we consider for mandatory declaration of non-statutory nutrients (see section I.C.), we are proposing to amend § 101.9(c)(8)(ii) to require the mandatory declaration of potassium. 3. Other Essential Vitamins and Minerals Several other essential vitamins and minerals, in addition to vitamin D and potassium, may be declared on the Nutrition Facts label, i.e., vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, and chloride. In response to the 2007 ANPRM about what, if any, other micronutrients are of public health significance, several comments recommended mandatory declaration of these voluntarily declared essential vitamins and minerals: Vitamin E, folate, vitamin B12, magnesium, and phosphorus. The reasons cited in E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 comments included: (1) The 2005 DGA identification of these nutrients as nutrients of concern (Ref. 36); (2) the need to provide information to patients; (3) the need to heighten consumer awareness; and (4) the intakes of these nutrients are inadequate in the U.S. population or subpopulations (Ref. 47). Based on FDA’s analysis of available data using the factors we consider for mandatory and voluntary declaration of non-statutory nutrients (see section I.C.) and comments received on essential vitamins and minerals that are currently voluntarily declared, we are not proposing any changes to the current provisions for voluntary declaration (for detailed information and the analysis of each of the vitamins and minerals see Ref. 115). We reviewed data related to the intake and status of nutrients where available standards allow for such calculations (table 1). Consistent with the factors (see section I.C.), essential vitamins and minerals (with the exception of potassium and vitamin D discussed previously) that are voluntarily declared should continue to be permitted to be voluntarily declared (Ref. 115). Therefore, we are not proposing any changes to the provisions for voluntary declaration of vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, and chloride. In addition, several comments recommended mandatory declaration of choline, which is currently not permitted to be declared on the Nutrition Facts label. Based on the factors we consider (see section 1.C.) and comments that asked us to provide for its declaration on the Nutrition Facts label (Ref. 115), we tentatively conclude that the voluntary declaration of choline is consistent with the factors we consider for voluntary declaration (table 1) and, therefore, we are proposing to permit the voluntary declaration of choline on the Nutrition Facts label. 4. Summary In summary, based on an analysis of the factors FDA considered (as described in section I.C.), comments received, and other data and information set forth previously, FDA VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 tentatively concludes that calcium, iron, vitamin D and potassium are nutrients of public health significance and their declarations on the Nutrition Facts label are necessary to assist consumers in maintaining healthy dietary practices. Calcium is considered a nutrient of public health significance due to the benefits of adequate calcium intake on bone health, and the relatively low intakes of calcium and the high prevalence of osteoporosis and osteopenia among the U.S. population. Iron is considered a nutrient of public health significance due to the continued inadequate intakes and deficiency (using relevant biomarker data) among women of childbearing age, who comprise a significant portion of the general healthy U.S. population. Although the DRIs for iron were not based on a chronic disease risk, iron deficiency and low iron stores over time will lead to iron deficiency anemia, an advanced stage of iron deficiency. Anemia is associated with poor cognitive function, lower work performance, and low endurance in the general population; delayed psychomotor development in infants; and adverse pregnancy outcome. Vitamin D is considered a nutrient of public health significance due to the benefits of adequate vitamin D intake on bone health, data indicating inadequate intakes and status (both from total exposure (serum data) and dietary intake data), and the high prevalence of osteoporosis and osteopenia among the U.S. population. Adequate intake of vitamin D is essential for promoting calcium absorption in the gut and for maintaining adequate calcium levels in the blood and thus promoting bone health. Potassium is considered a nutrient of public health significance due to the benefit of adequate intake of potassium in lowering blood pressure, reducing the adverse effects of sodium chloride intake on blood pressure and reducing the risk of recurrent kidney stones, and due to data indicating a low likelihood of potassium adequacy and a high prevalence of hypertension among the general U.S. population. Although we continue to consider, consistent with our rationale put forth in 1993, that a vitamin or mineral’s public health significance should be the PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 11923 key factor in mandatory labeling (58 FR 2079 at 2106), the proposed vitamins and minerals of public health significance (i.e., potassium, calcium, vitamin D, and iron) and dietary fiber (listed on the label as a nutrient to increase) do represent various food groups. For example, potassium is found in most food groups, especially vegetables, fruits, and milk and milk products. Milk and milk products contribute substantially to calcium intake. Sources of heme iron include lean meat, poultry and seafood, while the non-heme sources of iron come from plants foods, such as beans, lentils and spinach. Although vitamin D is mostly found in fortified foods in the United States, such as fluid milk and some milk products (e.g., yogurt), its natural sources include seafood. Dietary fiber is generally found in most fruits and vegetables, whole grains and beans. The 2010 DGA recommends increasing the amount and variety of seafood in place of some meat and poultry (Ref. 6). As mentioned, fish/ seafood is the primary source of naturally occurring vitamin D (Ref. 6). Data shows that fish/seafood only provides 9 percent of the total vitamin D intake in the United States (Ref. 116). Therefore, we tentatively conclude that the proposed mandatory declaration of vitamin D on the label would allow consumers to understand the relative significance of the contribution of vitamin D from natural food sources, in addition to fortified foods, in the context of the total daily diet and also is necessary to assist consumers in maintaining healthy dietary practices. We are not aware of any unintended consequences of mandatory listing, in general, of vitamins and minerals. We invite comment, including the submission of data and information on whether the mandatory listing of vitamins and minerals somehow impacts food fortification practices. We invite comment on the proposed mandatory declaration of vitamin D, potassium, calcium and iron on the label, including how we consider the public health significance of each. We also invite comment on whether the presence of these nutrients presents concerns related to label space or the need for consumer education. E:\FR\FM\03MRP2.SGM 03MRP2 11924 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules TABLE 1—PREVALENCE OF ADEQUACY AND INADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS FOR ESSENTIAL VITAMINS AND MINERALS AMONG THE U.S. POPULATION, AGES 4 YEARS AND OLDER [Excluding pregnant and lactating women] 1 Usual nutrient intake 2 Weighted EAR/AI 3 Nutrients Status biomarkers % above weighted intake) % Below weighted EAR 4 AI 5 (mean Biomarker cutoff Food Food plus supplement % Below cutoff Food plus supplement Food Vitamins Choline (NHANES 2005–2008). Folate ............. 460 mg (AI) .... ........................ ........................ 10 (mean = 311 mg). 10 (mean = 312 mg). NA .............................. NA 304 mcg DFE 8.7 .................. 7.3 .................. ........................ ........................ Serum folate < 2 ng/ mL. RBC folate < 95 ng/ mL Women 12–49 yrs Serum folate < 2 ng/ mL RBC folate < 95 ng/ mL NA .............................. NA .............................. NA .............................. Serum A < 20 mcg/dL NHANES 2005–2006 < 20 nmol/L. Serum B12 < 200 picograms (pg)/mL. 19–50 yrs ................... 51 yrs and older ......... 0 Niacin 6 7 ......... Riboflavin 6 7 ... Thiamin 6 7 ...... Vitamin A ....... Vitamin B6 6 7 .. 11 mg NE ...... 0.9 mg ............ 0.9 mg ............ 531 mcg RAE 1.1 mg ............ 2.1 .................. 1.5 .................. 5.6 .................. 45 ................... 9.4 .................. 1.7 .................. 1.3 .................. 3.8 .................. 34 ................... 7.3 .................. ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ Vitamin B12 ..... 1.9 mcg .......... 2.3 .................. 2.2 .................. ........................ ........................ 2 mcg (51 yrs and older). Women 51 yrs and older. 6.4–7.5 Men 51 yrs and older 0.6–0.7 35 ................... 27.5 ................ ........................ ........................ Women 12–49 yrs. 41 ................... 93.7 (NHANES 2005–2008). Women 12–49 yrs. 30 62 (NAHNES 2005–2008). ........................ ........................ ........................ ........................ Vitamin C ....... Vitamin D ....... Vitamin E ....... Vitamin K 6 7 ... 61 mg ............. 10 mcg ........... 11 mg a-tocopherol. 95 mcg (AI) .... 92 ................... 64 ................... ........................ ........................ ........................ ........................ 27.2 (mean = 82.9 mcg). 30.9 (mean = 88 mcg). 0.26 0 0.36 NA NA NA 0.3 8 10 2.0 0.7–2.5 3.3–5.2 Serum C < 11.4 μmol/ L. Women 12–49 yrs ..... 6.1 8 Serum 25 (OH)D: <40 nmol/L. 30–50 nmol/L ............. < 30 nmol/L ................ Serum E < 11.6 μmol/ L. NA .............................. 17.6 6.00 24 8.3 0.9 8 NA Minerals mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Calcium .......... Copper 6 7 ....... Iron (probability approach method) 9. 885 mg ........... 0.7 mg ............ See footnote 3 49 ................... 5.2 .................. 3.5 .................. 37 ................... 4.9 .................. 3.3 .................. Women 12–49 yrs. 11.2 ................ Iodine 6 7 ......... VerDate Mar<15>2010 91 mcg ........... 20:43 Feb 28, 2014 2.3 .................. ........................ ........................ ........................ Women 12–49 yrs. 10.4 2.3 11 .............. ........................ ........................ ........................ Jkt 232001 PO 00000 Frm 00046 ........................ Fmt 4701 Sfmt 4702 ........................ E:\FR\FM\03MRP2.SGM NA .............................. NA .............................. NHANES 1999– 2002 10. NA NA Serum ferritin < 15 mcg/L. Ferritin model ............. Anemia ....................... Women, 12–49 yrs NHANES 2003–2006: Serum Ferritin < 15 mcg/L Body Iron model ........ Ferritin Model Anemia Urinary iodine NHANES 2007–2008: 8.3 03MRP2 6.5 1.9 14 10 14.5 4.7 11925 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules TABLE 1—PREVALENCE OF ADEQUACY AND INADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS FOR ESSENTIAL VITAMINS AND MINERALS AMONG THE U.S. POPULATION, AGES 4 YEARS AND OLDER—Continued [Excluding pregnant and lactating women] 1 Usual nutrient intake 2 Weighted EAR/AI 3 Nutrients Status biomarkers % above weighted intake) % Below weighted EAR 4 AI 5 (mean Biomarker cutoff Food plus supplement Food <50 ng/mL 12 .............. <100 ng/mL 13 ............ Magnesium .... Phosphorus .... Potassium ...... 283 mg ........... 640 mg ........... 4,622 mg (AI) 56 ................... 3 ..................... ........................ 53 ................... 2.6 .................. ........................ Selenium 6 7 .... Zinc 6 7 ............ 43 mcg ........... 7.7 mg ............ 1.4 .................. 13.4 ................ 1.1 .................. 9.1 .................. % Below cutoff Food plus supplement Food ........................ ........................ 1.9 (mean = 2,644 mg). ........................ ........................ ........................ ........................ 2.4 (mean = 2,654 mg). ........................ ........................ NA .............................. NA .............................. NA .............................. 8.7 8. Median = 165 ng/mL. NA. NA. NA. NA .............................. NA .............................. NA. NA. NA = Data is not available in NHANES; mg = milligrams; mcg = micrograms; DFE = Dietary folate equivalents; NE = Niacin equivalents; RAE = Retinol activity equivalents. 1 All prevalence of nutrient adequacy or inadequacy and status biomarker data is based on NHANES 2003–2006 unless otherwise is reported. All data analysis are based on ages 4 years and older (excluding pregnant and lactating women), unless reported otherwise. 2 Usual nutrient intake distributions from conventional foods or conventional foods plus supplements are determined using the National Cancer Institute statistical method for all nutrients except iron (see footnote 9 to this table and Ref. 48). 3 Weighted Estimated Average Requirement (EAR) and Adequate Intake (AI) for all nutrients (except iron) are based on the U.S. population ages 4 years and older using U.S. Census Bureau, Population Projection for 2005, Middle Series Data (NP–D1–A) (Ref. 48,117). For iron, the published IOM tables (tables I–6 and I–7) of probability of iron requirement distribution were used (Ref. 100). 4 EAR cut-point method used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy. 5 For nutrients with an AI, prevalence of nutrient adequacy was determined when mean usual nutrient intakes are at or above the AI or based on the percent of those above the AI. 6 The Agency did not receive any comments for these nutrients (which voluntary declaration is permitted) in response to the 2007 ANPRM. In addition, dietary intake or status biomarker data were not provided in the NHANES database for chromium, biotin, pantothenic acid, molybdenum, manganese and chloride and, therefore, these nutrients are not listed in this table. 7 The DRIs for these nutrients were not based on a public health endpoint (e.g., chronic disease). 8 Ages 6 years and older. 9 Probability approach method was used to determine the prevalence of nutrient inadequacy for iron. The PC–SIDE software developed by the Iowa State University was used to determine the usual intake distribution for iron. 10 Iron deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables (transferrin saturation, serum ferritin, and erythrocyte protoporphyrin). Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to ferritin. Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. NHANES 1999–2002 did not measure transferrin receptor, therefore body iron model could not be analyzed for the general population (ages 4 years and older). NHANES 2003–2006 did not measure all iron biomarkers for all ages (4 years and older), thus serum ferritin, body iron model or ferritin model could not be analyzed for all ages during this time period. 11 Iodine nutrient intake data are calculated from the Total Diet Study 2003–2008 and intake data are calculated from NHANES 2003–2008 (https://www.nutrientdataconf.org/PastConf/NDBC36/7–3_Juan_NNDC2012.pdf). 12 One criterion for iodine adequacy is that not more than 20 percent be below the urinary iodine cutoff of 50 ng/mL (indicator of moderate deficiency) (Ref. 118). 13 WHO categories for median urinary iodine concentrations are widely used to define iodine intake (Ref. 118). Median intake levels below 100 ng/mL may indicate mild iodine deficiency. I. Reference Daily Intakes for Vitamins and Minerals mstockstill on DSK4VPTVN1PROD with PROPOSALS2 1. Need To Update RDIs RDIs used to calculate the percent DVs for vitamins and minerals that are required or permitted to be declared on the Nutrition Facts label are codified in § 101.9(c)(8)(iv). We established the RDIs in 1993 and in 1995, and explained our rationale and relevant considerations during those rulemakings (58 FR 2079; 60 FR 67164; see also Ref. 1). We noted specifically that the purpose of establishing RDIs for vitamins and minerals was to provide ‘‘label reference values’’ intended to help consumers to understand nutrient levels in the context of the total daily diet, to compare foods, and to plan general diets (58 FR 2206 at 2213). We VerDate Mar<15>2010 20:43 Feb 28, 2014 Jkt 232001 recognized that nutritional needs vary considerably among consumers, but noted that no other viable option existed other than a single reference value (58 FR 2206 at 2213). Thus, RDIs are intended as general food labeling reference values and are not intended to represent dietary allowances for individuals (55 FR 29476 at 29478). While RDIs are not precise values for certain age and sex groups, they function as an overall population reference to help consumers judge a food’s usefulness in meeting overall daily nutrient requirements or recommended consumption levels and to compare nutrient contributions of different foods (55 FR 29476). IOM reports published since 1997 provide new information for our use in reconsidering the RDIs. The DRIs PO 00000 Frm 00047 Fmt 4701 Sfmt 4702 revised many of the previously set RDAs for vitamins and minerals. Four types of DRIs are relevant to the discussion on RDIs for vitamins and minerals: EAR, RDA, AI, and UL. We describe each of these DRIs in section I.B.2. According to the new DRI reports, some nutrients that had RDAs now have an AI because it was determined that data were not sufficient to set a new RDA (e.g., vitamin K), whereas others that had ESADDIs now have either an RDA (copper and molybdenum) or an AI (manganese, fluoride, and chromium). The IOM Labeling Report (Ref. 25) recommended that FDA use a population-weighted EAR or, in its absence, a population-weighted AI as the basis for establishing DVs for vitamins and minerals. In developing these recommendations, the IOM E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11926 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules indicated that the reference values on food labeling are to enable consumers to compare the nutrient content of different food products and to determine the relative contributions of a food to an overall health promoting diet. The IOM Labeling Committee did not consider that the information in nutrition labeling is used to plan individual diets. The IOM recommended that the DVs should be based on a population-weighted value of the EAR for the different life stage and gender groups so that the DVs are representative of the various population groups in proportion to their contribution to the overall population. A DV defined this way would represent a central value of the requirements of the population, with individual requirements varying around this value. The IOM Labeling Committee further stated that the EAR represents the most accurate representation of the true contribution of food to total nutrient needs of the general population, whereas the RDA provides an exaggerated impression of Americans’ daily needs and, thus, would systematically under-represent the true contribution of an individual food to many consumers’ needs. The IOM Labeling Committee concluded that the EAR is the best estimate of any given individual’s requirements, because the EAR is the median of the estimated distribution of requirements for a particular life stage and gender group. Therefore, the IOM Labeling Committee stated that setting the DV at the EAR is most likely to help individuals understand nutrition information about vitamins and minerals on the Nutrition Facts label in the context of their total daily diet. The IOM Labeling Committee further recommended that, in the absence of an available EAR, a population-weighted AI should be used as the basis for a DV. The IOM Dietary Planning Report noted that intake goals (i.e., RDAs) should be translated into dietary plans to help individuals choose foods that will make up a healthful diet. The IOM Dietary Planning Report gave several examples of dietary plans such as the Nutrition Facts label, United States Food Guide Pyramid and the Dietary Guidelines for Americans that are intended to help consumers choose foods that are part of a healthful diet (Ref. 26). This report noted that when food guides such as those mentioned previously are used, reference standards for nutrients, such as RDAs, are implicitly used in planning individual diets (Ref. 26). The recommendations in the IOM Labeling Report and the IOM VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Dietary Planning Report have been the subject of much debate in the scientific community, and several review articles about the basis for selecting the DRI values that are most appropriate for setting DVs (i.e., RDIs) have been published in scientific journals (Refs. 119 to 126). The 2007 ANPRM asked for public comment on whether the DV should be based on an EAR or RDA; how AIs should be used for determining DVs for vitamins and minerals without an EAR or RDA; and whether DVs should be based on a population-coverage or population-weighted approach. We received several comments both on the overall approach for setting the RDIs and on the DRIs for specific vitamins and minerals (Ref. 47). We tentatively conclude that the existing RDIs for vitamins and minerals should be revised based on the DRIs set by the IOM that reflect the most current science regarding nutrient requirements. Our consideration of the DRIs, relevant recommendations, and comments received in updating the RDIs is presented in this document. 2. Approach to Setting RDIs: EAR Versus RDA The percent DV advises the consumer how much of the recommended intake of that nutrient is provided by the food (58 FR 2206 at 2213). The DV for the nutrient, on which the percent DV declaration is based, is not to be interpreted as a precise recommended intake level for an individual; it is for use as a general guide or reference value that can help the consumer judge a food’s usefulness in meeting overall daily nutrient requirements or recommended consumption levels and to compare nutrient contributions of different foods (55 FR 29476). We established the RDIs for vitamins and minerals based primarily on RDAs, and using other available recommendations for those vitamins and minerals for which an RDA was not established (55 FR 29476; 58 FR 2206; 60 FR 67164). Overall, comments to the 2007 ANPRM supported continuing to use the RDA as the basis for the DVs for vitamins and minerals, whereas some other comments supported using the EAR instead (Ref. 47). Considering the purpose of the DV, and for the reasons explained in this document, we tentatively conclude that RDAs, when available, continue to provide the most appropriate basis for establishing RDIs. RDAs are available for calcium, copper, folate, iodine, iron, magnesium, molybdenum, niacin, phosphorus, riboflavin, selenium, PO 00000 Frm 00048 Fmt 4701 Sfmt 4702 thiamin, vitamins A B6, B12, C, D, and E, and zinc (Refs. 16 to 19,22). The EAR, by definition, is the median requirement that is most likely to be close to an individual’s actual needs within a particular life stage and gender group, with the needs of half of the individuals within that group falling above or below the EAR. The EAR is a quantitative intake recommendation that is used to derive target nutrient intake goals for the planning of diets for groups, but is not used as a target intake goal for individuals. Examples of planning for groups include planning diets in an assisted living facility for senior citizens or planning menus for a school nutrition program (Ref. 26). However, the EAR is not intended to be a target intake level for individuals because an individual does not know how their needs relate to the EAR. While the RDA may not be the best estimate of any given individual’s nutrient requirement, which is usually unknown, the RDA was developed as a target intake level for individuals and is designed to meet the nutrient needs of practically all (97 to 98 percent) individuals within a life stage and gender group. Therefore, if the RDI were to be based on the EAR, the RDI would not meet the daily nutrient requirements for some consumers and understate target intake levels. In contrast, an RDI that is based on a RDA would meet the daily nutrient requirements for the majority of all individuals 4 years of age and older. As we explained during the NLEA rulemaking, while RDIs are not precise values for specific age and sex groups, they function as an overall population reference to help consumers judge a food’s usefulness in meeting overall daily nutrient requirements or recommended consumption levels and to compare nutrient contributions of different foods (55 FR 29476). An RDI based on the RDA would mean that a product with 100 percent of the DV would have a higher probability of meeting an individual’s nutrient needs than if the RDI was based on the EAR. In addition, consumers have indicated that they use the label, among other things, to make dietary judgments about a food and to plan meals. Our 2008 Diet and Health Survey reported that, among consumers who use the label when they buy a product for the first time, 62 percent often or sometimes use the label to help in meal planning; 85 percent often or sometimes use the label to get a general idea of the nutritional content of the food; and 90 percent often or sometimes use the label to see how high or low the food is in things like calories, salt, vitamins, or fat (Ref. 41). A series of surveys conducted by the E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules International Food Information Council over the past several years also showed that approximately 65 percent of respondents used the Nutrition Facts label to decide whether to purchase or consume a food, and different individuals focus on different aspects of the label (e.g., calories, fat, or sodium) (Refs. 127 to 130). We recognize that the recommendations of the 2003 IOM Labeling Report (Ref. 25) differ from the conclusions of the 2003 IOM Planning Report (Ref. 26). The IOM Labeling Report recommends using the EAR as the basis for developing DVs, whereas the IOM Planning Report indicated that the RDAs are appropriate targets for nutrient intakes for individuals. Inadequate intakes of some nutrients continue to be of public health significance, as noted by the 2010 DGA, which identified potassium, calcium, and vitamin D as nutrients of public health concern for general U.S. population and iron, folic acid, and vitamin B12 for certain segments of the population (Ref. 6). Based on these concerns of inadequate nutrient intakes, we find that the IOM Dietary Planning Report discussion supports the use of RDAs as the basis for establishing reference values for the purposes of food labeling. We continue to believe that given the greater coverage provided by the RDAs compared to the EARs, more individuals who use the percent DV information to select foods, compare foods, or plan diets will have greater assurance that their nutrient needs are being met (58 FR 2206 at 2213). RDAs and AIs, not EARs, are also cited in both the 2010 DGA and the USDA’s Food Patterns, which were formerly known as the MyPyramid Food Patterns (Refs. 6 and 131). It is important to reiterate, however, that the RDIs are not the same as RDAs. The RDAs are recommended intake levels set for different age and gender groups, whereas the RDIs are intended to provide an overall population reference value for use in calculating the percent DV for the food label that can help consumers understand the nutritional content of foods in the context of the total daily diet (55 FR 29476 at 29481 and 58 FR 2206 at 2213). Finally, we considered the potential for the RDIs to influence the vitamin or mineral content of foods, as suggested by several comments (Ref. 47). We are not persuaded that using an EAR will promote rational fortification and that using the RDA as the basis for the RDI will lead to overconsumption of vitamins and minerals, as was suggested by a comment (Ref. 47). FDA’s principles of rational fortification are VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 expressed in our fortification policy (§ 104.20). The addition of nutrients to foods is also governed by the requirements established in food standards of identity (21 CFR parts 130 to 169), nutrition quality guidelines (21 CFR part 104), substitute food regulations (§ 101.3(e)), and relevant specifications in food additive and food substance regulations (for example, folic acid (§ 172.345) and vitamin D (§§ 184.1950 and 172.380)). Consistent with our previous position (58 FR 2206 at 2210), we acknowledge that some manufacturers may fortify products to a specific percentage of the DV (e.g., 25 percent) and, to the extent this practice continues, nutrient levels in these foods would be affected by updated RDI values. Changing the basis from the current RDA approach to EARs would lower RDIs for many important nutrients. Regardless of whether the basis for the RDI is the RDA or EAR, manufacturers must comply with relevant regulations, and we urge them to follow the principles stated in our fortification policy. With respect to the concern for risk of excessive intakes of vitamins and minerals, we conducted a thorough analysis of available data to determine whether intakes of vitamins and minerals from both foods and dietary supplements exceed established ULs. An analysis of NHANES (2003– 2006) data showed that usual total nutrient intakes (from both conventional foods and dietary supplements) at the 90th percentile do not exceed the ULs for most vitamins and minerals at any age group, except for zinc intake, vitamin A (preformed), iodine intake and folic acid intake among children 4 to 8 years (Ref. 132). While there were a few exceptions, we have determined that such intakes are not of public health significance, and for some nutrients, are not a result of discretionary fortification. Therefore, we do not consider that the existing approach of using RDAs as the basis for RDIs leads to widespread overconsumption of vitamins and minerals. Moreover, about half of the proposed RDIs decrease when compared to the current RDIs (table 2) because many of the new RDAs and AIs established by the IOM are now lower than previously set RDAs or ESADDIs. Most of the RDIs proposed in this rulemaking that would increase (i.e., calcium, vitamin D, dietary fiber, and potassium) have also been proposed by FDA to be nutrients of public health significance for the general U.S. population (see section II.H.). Furthermore, none of the RDIs proposed in this rulemaking exceed the ULs for PO 00000 Frm 00049 Fmt 4701 Sfmt 4702 11927 children 4 to 8 years of age (see tables 11a and 11b of the 2007 ANPRM). Therefore, we tentatively conclude that RDAs, when available, provide the most appropriate basis for establishing RDIs. Using corresponding RDAs, proposed § 101.9(c)(8)(iv) would update the RDIs for calcium, copper, folate, iodine, iron, magnesium, molybdenum, niacin, phosphorus, riboflavin, selenium, thiamin, vitamins A, B6, B12, C, D, and E, and zinc, as shown in table 2. We request comment on our analysis and request data and factual information, including any additional data on what role, if any, the basis of the DV (EAR or RDA) has in consumption of nutrients above the UL and in discretionary fortification of foods. 3. Approach to Setting RDIs: Adequate Intake We consider that, in the absence of RDAs, AIs represent the best estimate of adequate daily nutrient intake level based on available science and, as such, they provide an appropriate basis for selecting RDIs for those vitamins and minerals where available data are insufficient to determine RDAs. While the prevalence of inadequacy of a nutrient with an AI cannot be determined, AIs, like RDAs, are goals for nutrient intakes and AIs are expected to meet the nutrient needs of most healthy people. The IOM noted that usual individual intakes for a nutrient that are equal to or above the AI can be assumed adequate (Ref. 25). We acknowledge that there is more uncertainty with an AI than an EAR or RDA. However, in the case of nutrients without established RDAs, AIs reflect the most current scientific recommendations for intake (Ref. 25). Moreover, using the AIs (where RDAs are not available) would ensure consistency in the basis of setting RDIs. We agree with comments to the ANPRM that RDIs for vitamins and minerals and consequently, percent DVs declared on the label, should have comparable meanings in order to enable consistent use. RDIs should not be based on average requirements (i.e., EAR) for some nutrients, but goals for intakes (i.e., RDAs) for others. AIs, in the absence of RDAs, would provide uniformity in setting RDIs for vitamins and minerals based on goals for their intakes. Most of the comments in response to the 2007 ANPRM supported the AI as the basis for the DV for those nutrients for which no EARs or RDAs have been established (i.e., biotin, chloride, choline, chromium, manganese, pantothenic acid, potassium, and vitamin K) (Ref. 47). E:\FR\FM\03MRP2.SGM 03MRP2 11928 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules Therefore, we tentatively conclude that AIs provide an appropriate basis for selecting RDIs for those vitamins and minerals where available data are insufficient to determine RDAs. Accordingly, we are proposing to use AIs to set the RDIs for biotin, chloride, choline, chromium, manganese, pantothenic acid, potassium, and vitamin K. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 4. Approach to Setting RDIs: Tolerable Upper Intake Level The UL is the highest average daily intake level likely to pose no risk of adverse health effects for nearly all people in a particular group. As intake increases above the UL, potential risk of adverse effects may increase (Ref. 96). The UL can be used to estimate the percentage of the population at potential risk of adverse effects from excess nutrient intake (Ref. 25). However, the UL is not intended to be a recommended level of intake for vitamins and minerals where excess intake is not a concern, as there is generally (with the exception of folate in the prevention of neural tube defects) no established benefit for consuming amounts of nutrients above the RDA or AI (Ref. 96). Therefore, we do not consider the UL to be an appropriate basis for setting RDIs. However, as the IOM noted, ULs can be used to plan diets to ensure usual intakes of vitamins and minerals are below the UL for individuals or to plan diets for groups to minimize the proportion of the population at risk of excess nutrient intake (Ref. 25). Therefore, we tentatively conclude that the UL does not provide an appropriate basis for establishing RDIs for vitamins and minerals. As noted previously (sections II.I.2. and II.I.3.), we tentatively conclude that the RDAs and, for nutrients where an RDA has not been established, AIs are the most appropriate quantitative intake recommendations for setting RDIs that can help consumers to plan general diets and understand the nutritional content of the foods they buy in the context of the total daily diet. 5. Approach to Setting RDIs: Population-Weighted Versus Population-Coverage As discussed in the 2007 ANPRM, we set the RDIs based on a populationcoverage approach, after concluding that this approach was more appropriate than a population-weighted approach, in part, so that vulnerable or at-risk groups would be sufficiently covered by the DV (72 FR 62149 at 62150). In determining an approach for setting RDIs in this proposed rule, we VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 considered recommendations of current consensus reports, scientific review articles, and comments to the 2007 ANPRM. We presented a comparison of potential RDIs based on the various established DRIs and applying the population-coverage versus populationweighted approaches (see tables 11A and 11B of the 2007 ANPRM). As discussed in this document, we tentatively conclude that RDIs for vitamins and minerals should continue to be based on a population-coverage approach, using the highest RDA and, where an RDA has not been established, the highest AI. We continue to agree with the rationale we set forth in 1993 that the population-coverage approach would sufficiently cover the vulnerable or atrisk groups (58 FR 2206 at 2211). Using the highest age and gender group RDA/ AI value (i.e., a population-coverage approach) would avoid a higher risk of nutrient inadequacy among certain segments of the population because such a value is not derived from averaging the requirements for populations with lower needs (children and elderly) and those with greater needs (adolescents or adults). While incidences of deficiency diseases, such as pellagra, are now rare, intakes and status biomarkers of certain nutrients continue to be inadequate and of public health significance (see section II.H.). Although, for some nutrients, the population-coverage RDA approach would result in RDIs that are higher than the nutrient requirements for some consumers, RDA, by definition, is the target intake goal for nutrient intakes for individuals. In addition, as noted by one comment, unlike the populationweighted approach, the populationcoverage approach would not be susceptible to changes in age demographics of the population. Therefore, any future revisions to RDIs would be based primarily on new scientific data related to nutrition or new dietary recommendations, and we would not need to revise RDIs solely based on the availability of new census data. We also considered concerns that the population-coverage approach may lead to excessive intakes of nutrients. As in the case of the RDA approach (discussed previously), we find such concerns unfounded. Intakes of vitamins and minerals generally do not exceed the ULs under current RDIs that are based on a population-coverage RDA approach. In a few instances where total usual intakes of vitamins and minerals by children 4 to 8 years exceed corresponding ULs, we have determined that such intakes are not of public PO 00000 Frm 00050 Fmt 4701 Sfmt 4702 health significance, and for some nutrients, are not as a result of fortification (see accompanying Ref. 115). Furthermore, because many of the new RDAs and AIs established by the IOM are now lower than previously set RDAs or ESADDIs, the RDIs based on a population-coverage RDA for many nutrients will decrease (see table 2). We consider that, from a public health perspective, it is more important for the DV of vitamins and minerals to cover the intake needs of most consumers than it is for certain age and gender groups to be covered by the DV based on their proportion of the overall population. We are also not aware of any data indicating that use of a population-coverage approach versus a population-weighted approach results in increases in nutrient consumption. Therefore, we tentatively conclude that the population-coverage approach using the highest RDA or, in its absence, the highest AI continues to provide an appropriate basis for setting RDIs for vitamins and minerals. We are proposing to amend § 101.9(c)(8)(iv) to update RDIs as presented in table 2. 6. Declaration of Absolute Amounts of Vitamins and Minerals Currently, mandatory nutrients and, when declared, voluntary nutrients must be declared by their absolute amounts in weight on the Nutrition Facts label, except for vitamins and minerals (other than sodium and potassium) (see § 101.9(d)(7)(i)). Thus, except when the linear label format is used (§ 101.9(j)(13)(ii)(A)(2)), listings for sodium and potassium (when declared) appear above the third bar and include both weight amounts and percent DVs, while vitamins A and C, calcium, and iron appear below the third bar and include percent DVs only. In the case of dietary supplements, both the quantitative amount by weight and percent DV (if available) are required to be declared on the Supplement Facts label (§ 101.36(b)(2)(ii) and (iii)). The 2007 ANPRM invited comment on whether the absolute amounts (e.g., grams or milligrams) of mandatory and voluntary vitamins and minerals should be included on the Nutrition Facts and Supplement Facts labels (72 FR 62149 at 62170). Most comments supported including the absolute amounts of these nutrients in addition to the requirement of listing percent DVs. Research suggests that consumers, in general, and physicians who prescribe nutrient supplements for specific medical reasons have difficulty understanding how percent DVs relate to the absolute amounts of nutrients listed on the Nutrition Facts label (Ref. E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 133). More recently, in a report on labeling and fortification, the IOM recommended listing both absolute amounts (e.g., mg/serving) and percent DVs to assist consumers who have difficulty understanding how to interpret the percent DV declaration (Ref. 25). This IOM report also stated that absolute amounts declaration for all micronutrients would maintain consistency in how nutrients are declared on the Nutrition Facts label. Based on the IOM’s recommendation, research findings, and comments received, we are proposing to require that, similar to the requirement for dietary supplements (§ 101.36(b)(2)(i)(A)), all vitamins and minerals declared on the Nutrition Facts label must include their quantitative amounts (in addition to the requirement for corresponding percent DV declaration) (proposed § 101.9(c)(8)). We request comments on this tentative conclusion, and seek input on the appropriate placement of the quantitative amounts of nutrients on the Nutrition Facts label. Further, with the proposed requirement for declaration of absolute amounts of vitamins and minerals, it is necessary to establish when a vitamin or mineral is present in an insignificant amount as well as increments for declaration of the quantitative amounts of vitamins and minerals on the Nutrition Facts label. In determining requirements for vitamins and minerals present in insignificant quantities, as well as increments for declared vitamins and minerals, we looked to requirements that have already been established for declaration of quantitative amounts of sodium and potassium, vitamins and minerals declared on the Supplement Facts label, and percent DVs. Quantitative amounts in milligrams may currently be listed on the Nutrition Facts label for only two minerals: Sodium, a mandatory nutrient (§ 101.9(c)(4)) and potassium (§ 101.9(c)(5)), which may be voluntarily declared on the Nutrition Facts label. We require in § 101.9(c)(4) and (c)(5) that when a serving contains less than 5 mg of sodium or potassium, the value shall be declared as zero; when a serving contains 5 to 140 mg of sodium or potassium, the declared value shall be rounded to the nearest 5 milligram increment; and when a serving contains greater than 140 mg of sodium or potassium, the declared value shall be rounded to the nearest 10 mg increment. We are now proposing to establish an RDI for potassium. Since potassium will now have an RDI, rather than a DRV, we are proposing to remove the specific VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 requirements for the declaration of potassium in § 101.9(c)(5), and replace the section with requirements for the declaration of fluoride. Requirements for the declaration of quantitative amounts of other nutrients with an established RDI discussed in this document will apply to potassium, if finalized. The quantitative amounts by weight per serving of vitamins and minerals are also required to be declared on the Supplement Facts label (§ 101.36(b)(2)(ii)). The amounts of vitamins and minerals, excluding sodium and potassium, that are declared on the Supplement Facts label are the amount of the vitamin or mineral included in one serving of the product, using the units of measurement and levels of significance given in § 101.9(c)(8)(iv). Section 101.36(b)(2)(ii)(B) also specifies that for declaration of vitamins and minerals on the Supplement Facts label, zeros following decimal points may be dropped, and additional levels of significance may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole mg, but the quantitative amount may be declared in tenths of a mg). For conventional foods, FDA specifies in § 101.9(c)(8)(iii) that the percent DV declaration for vitamins and minerals present at less than 2 percent of the RDI is not required for nutrition labeling, but may be declared as zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement ‘‘Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).’’ Alternatively, the statement ‘‘Not a significant source of (listing the vitamins or minerals omitted)’’ may be placed at the bottom of the table of nutrient values. For the purpose of determining when a vitamin or mineral is present in an insignificant amount, we tentatively conclude that the cutoff used for declaration of percent DV of less than 2 percent of the RDI (§ 101.9(c)(8)(iii)) can reasonably be applied to the declaration of quantitative amounts of vitamins and minerals on the Nutrition Facts label. We find that, if a product contains less than 2 percent of the RDI per serving, it is appropriate to express the declared vitamin or mineral quantitative amount as zero. The manufacturer may choose to use an asterisk (or other symbol), instead of a declaration of zero, that refers to another asterisk (or symbol) placed at the bottom of the table and that is followed by the statement PO 00000 Frm 00051 Fmt 4701 Sfmt 4702 11929 ‘‘Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).’’ Alternatively, the statement ‘‘Not a significant source of (listing the vitamins or minerals omitted)’’ (‘‘not a significant source’’ statement) may be placed at the bottom of the table of nutrient values. As previously discussed, manufacturers have the option of using an asterisk (or symbol), instead of a declaration of zero, that directs the consumer to a statement indicating that the product is not a significant source of certain vitamins or minerals found at the bottom of the table of nutrient values when the calculated percent DV is less than 2 percent. We are concerned that it may be confusing to consumers if the manufacturer chooses to declare the quantitative amount of a vitamin or mineral as zero, and also chooses to use an asterisk referring the reader to a statement at the bottom of the label instead of in the percent DV column on the Nutrition Facts label. Therefore, we are proposing to require that, when a product contains less than 2 percent of the RDI for a vitamin or mineral, the manufacturer must declare the quantitative amount of the vitamin or mineral and the percent DV in the same manner. For example, if a serving of the product contains less than 2 percent of the RDI for calcium, both the quantitative amount and the percent DV for calcium may be listed as zero or an asterisk (or symbol) directing the consumer to a statement at the bottom of the label may be used in place of both the quantitative amount and the percent DV declaration for calcium. We see no reason to provide different declaration increments for the Nutrition Facts label than those that have already been established for the declaration of quantitative amounts of vitamins and minerals on the Supplement Facts label in § 101.36(b)(2)(ii). Therefore, we tentatively conclude that, as with the declaration of quantitative amounts of vitamins and minerals on the Supplement Facts label, the levels of significance given in § 101.9(c)(8)(iv) should be used. Zeros following decimal points may be dropped, and additional levels of significance may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole mg, but the quantitative amount may be declared in tenths of a mg). We acknowledge that for some vitamins and minerals with RDIs that contain three or four digits (e.g., phosphorous has a proposed RDI of 1,250 mg), a difference of 1 mg per serving may not be meaningful in terms E:\FR\FM\03MRP2.SGM 03MRP2 11930 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules of health impacts. We request comment on whether quantitative amounts for nutrients with RDI values that contain three or four digits should be rounded, what the rounding increments should be, and data to support suggested rounding increments for such vitamins and minerals. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 7. Issues Concerning Specific Vitamins and Minerals In this section, we address issues related to RDIs for specific vitamins and minerals, including those received in comments to the 2007 ANPRM. We discussed the declaration of these vitamins and minerals in section II.H. (and in accompanying Ref. 115). a. Vitamin K—There are three general forms of vitamin K: Phylloquinone (vitamin K1), menaquinone (vitamin K2), and menadione (vitamin K3). For labeling purposes, there is no specific definition for vitamin K. The AIs for vitamin K are based on median intakes from NHANES data, which specifically represents the intake of phylloquinone, the major form of vitamin K in the diet (Ref. 134). The AI for vitamin K does not account for the intake of menaquinone or menadione because (1) NHANES data only includes phylloquinone content of foods, (2) the contribution of menaquinones, which can be produced by bacteria in the gut, to the maintenance of vitamin K status has not been established, and (3) menadione is a synthetic form of vitamin K that can be converted to a form of menaquinone in animal tissues. Because the AI for vitamin K is specific to phylloquinone, our proposed RDI for vitamin K, 120 mcg in proposed § 101.9(c)(8)(iv), that is based on the AI pertains only to phylloquinone. b. Chloride—The RDI for chloride of 3,400 mg/d (§ 101.9(c)(8)(iv)) was established in 1995 and is based on the midpoint of the range (1,700 to 5,100 mg/d) of the ESADDI set in the 1980 RDA report (Ref. 135; 59 FR 427). The RDI for chloride is proportional to the DRV for sodium, considering that chloride losses tend to parallel losses of sodium and almost all dietary chloride comes from sodium chloride (60 FR 67164). The IOM set AIs and ULs for chloride on an equimolar basis to the AI and UL for sodium (Ref. 10). The 2007 ANPRM requested comment on whether (1) the DV for chloride should continue to be an RDI, or should be a DRV like VerDate Mar<15>2010 19:18 Feb 28, 2014 Jkt 232001 the current DV for sodium and (2) the DV for chloride should be based on the same DRI (AI versus UL) as used to set a DV for sodium. A few comments supported setting a DRV for chloride on an equimolar basis to the UL for sodium. We disagree because the UL for chloride was not based on adverse effects associated with excess intake of chloride. Furthermore, the UL was not based on a public health endpoint specific to chloride intake, which is a basis for setting a DRV. Because chloride is an essential mineral and has age- and gender-specific AIs, we tentatively conclude that chloride should remain a RDI and be based on population-coverage AI (see section II.I.5.). Therefore, we are proposing to set an RDI for chloride using the population-coverage AI of 2,300 mg/d (proposed § 101.9(c)(8)(iv)). c. Potassium—The DRV of 3,500 mg/ d for potassium was established based on its beneficial health effects (e.g., reduction in blood pressure) (55 FR 29487 at 29500). We established a DRV rather than an RDI because an RDA for specific age and gender groups was not established at that time. In 2005, the IOM established age- and genderspecific AIs for potassium based on data showing that potassium lowers blood pressure, blunts the adverse effects of sodium chloride intake on blood pressure, reduces the risk of recurrent kidney stones, and possibly decreases bone loss (Ref. 136). Because potassium is an essential mineral and age- and gender-specific AIs are available, we tentatively conclude that an RDI should be established in place of the DRV. Therefore, using the populationcoverage AI, we are proposing to establish an RDI for potassium of 4,700 mg/d (proposed § 101.9(c)(8)(iv)). d. Choline—FDA regulations do not establish a reference value for choline. In 1998, the IOM established age- and gender-specific AIs for choline based on intakes necessary to maintain liver function (Ref. 137). In 2001, we received a FDAMA notification under section 403(r)(2)(G) of the FD&C Act for the use of certain nutrient content claims for choline (Ref. 138). The FDAMA notification identified the DV for choline as 550 mg, which was based on the population-coverage AI for choline. Because the IOM established age- and gender-specific AIs for choline, we tentatively conclude that an RDI should PO 00000 Frm 00052 Fmt 4701 Sfmt 4702 be established. Thus, we are proposing in § 101.9(c)(8)(iv) to set an RDI of 550 mg for choline based on the populationcoverage AI. e. Vitamin B12—We are proposing to lower the RDI for Vitamin B12 from 6 to 2.4 mg/day which reflects the population-coverage RDA for Vitamin B12. The RDAs for Vitamin B12 were established by the IOM in 2000. The IOM noted that 10 to 30 percent of individuals older than 50 years of age are estimated to have atrophic gastritis with low stomach acid secretion which can decrease the bioavailability of naturally occurring vitamin B12 in food (Ref. 17). The bioavailability of crystalline vitamin B12 that is added to food is not altered in people with this condition. While the IOM set an RDA of 2.4 mg/d that can be met by consuming natural and crystalline forms of vitamin B12 and is for all adults, it was noted that it is advisable that individuals older than 50 years of age meet their RDA mainly by consuming foods fortified with crystalline vitamin B12 or vitamin B12-containing supplements. If the RDI is lowered from 6 to 2.4 mg, it is possible that the fortification level in foods, such as ready-to-eat breakfast cereals, may be lowered, decreasing the overall amount of crystalline vitamin B12 in the food supply. Given the current level of fortification in food, less than 1 percent of men and 6.4 to 7.5 percent of women older than 50 years of age consume below the EAR for vitamin B12, while only 3 to 5 percent of men and women in this age group have serum vitamin B12 levels that are considered to be inadequate (2003–2006 NHANES) (table 1). Reflecting the current food supply and regulations, data from NHANES (2003–2006) indicate that ready-to-eat cereal is the primary source of crystalline B12 added to food, providing approximately 14.6 percent of the total vitamin B12 consumed by individuals 51 years of age and older (Ref. 139). Dietary supplements appear to be an important contributor of vitamin B12 for this age group because the mean increase in vitamin B12 intake ranged between 2.5 and 4.7 mg/d when comparing intake from food only compared to food plus dietary supplements (NHANES 2003– 2006) (table 1). We request comment and data on lowering the RDI for vitamin B12 to 2.4 mg. E:\FR\FM\03MRP2.SGM 03MRP2 11931 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules TABLE 2—CURRENT AND PROPOSED RDIS FOR NUTRITION LABELING [Based on a 2,000 calorie intake for adults and children 4 or more years of age] Nutrient Current RDIs Vitamins: Biotin .......................................................................... Choline ....................................................................... Folate ......................................................................... Niacin ......................................................................... Pantothenic acid ......................................................... Riboflavin .................................................................... Thiamin ....................................................................... Vitamin A .................................................................... Vitamin B6 .................................................................. Vitamin B12 ................................................................. Vitamin C .................................................................... Vitamin D .................................................................... Vitamin E .................................................................... Vitamin K .................................................................... Minerals: Calcium ...................................................................... Chloride ...................................................................... Chromium ................................................................... Copper ........................................................................ Iodine .......................................................................... Iron ............................................................................. Magnesium ................................................................. Manganese ................................................................. Molybdenum ............................................................... Phosphorus ................................................................ Potassium 2 ................................................................ Selenium .................................................................... Zinc ............................................................................. Proposed RDIs 300 micrograms ................................................................ 550 1 milligrams ................................................................. 400 micrograms ................................................................ 20 milligrams ..................................................................... 10 milligrams ..................................................................... 1.7 milligrams .................................................................... 1.5 milligrams .................................................................... 5,000 International Units ................................................... 2.0 milligrams .................................................................... 6 micrograms .................................................................... 60 milligrams ..................................................................... 400 International Units ...................................................... 30 International Units ........................................................ 80 micrograms .................................................................. 30 micrograms. 550 milligrams. 400 micrograms DFE. 16 milligrams NE. 5 milligrams. 1.3 milligrams. 1.2 milligrams. 900 micrograms RAE. 1.7 milligrams. 2.4 micrograms. 90 milligrams. 20 micrograms. 15 milligrams. 120 micrograms. 1,000 milligrams ................................................................ 3,400 milligrams ................................................................ 120 micrograms ................................................................ 2.0 milligrams .................................................................... 150 micrograms ................................................................ 18 milligrams ..................................................................... 400 milligrams ................................................................... 2.0 milligrams .................................................................... 75 micrograms .................................................................. 1,000 milligrams ................................................................ 3,500 milligrams ................................................................ 70 micrograms .................................................................. 15 milligrams ..................................................................... 1,300 milligrams. 2,300 milligrams. 35 micrograms. 0.9 milligrams. 150 micrograms. 18 milligrams. 420 milligrams. 2.3 milligrams. 45 micrograms. 1,250 milligrams. 4,700 milligrams. 55 micrograms. 11 milligrams. RAE = Retinol activity equivalents; 1 RAE = 1 mcg retinol, 12 mcg b-carotene, or 24 mcg a- carotene, or 24 mcg b-cryptoxanthin. NE = Niacin equivalents, 1 mg niacin = 60 mg of tryptophan. DFE = Dietary folate equivalents; 1 DFE = 1 mcg food folate = 0.6 mcg of folic acid from fortified food or as a supplement consumed with food. 1 A notification was submitted under section 403(r)(2)(G) of the FD&C Act in 2001 for the use of certain nutrient content claims for choline. These statements identify the daily value for choline as 550 mg. This value is based on the AI set by the IOM of the NAS in 1998 (Refs. 138 and 137). 2 These minerals currently have a DRV and we are proposing to establish an RDI. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 J. Units of Measure, Analytical Methods, and Terms for Vitamins and Minerals As discussed in this document, the IOM set DRIs using new units of measure for vitamin A, vitamin E, and folate, as well as provided recommendations on the use of International Units (IUs), and expression of weight amounts for sodium, potassium, copper, and chloride (Refs. 17 to 19,25). The new units of measure for vitamin A, vitamin E, and folate affect how total amount of each nutrient is measured. The 2007 ANPRM asked several questions about these issues. We discuss our reconsideration of the units of measure, analytical methods, and terms used in declaration of specific vitamins and minerals in this section. 1. Sodium, Potassium, Copper, and Chloride The absolute amount declaration for sodium, potassium, copper, and chloride must be expressed in mg (§ 101.9(c)(8)(iv) and (c)(9)). However, in the DRI reports for these nutrients, these nutrients are expressed as grams VerDate Mar<15>2010 19:18 Feb 28, 2014 Jkt 232001 (sodium, potassium, chloride) or micrograms (copper) (Refs. 21,140). The IOM Labeling Committee recommended that the current requirement for units of measurement used in the declaration of these nutrients should be changed to be consistent with the units used in the new DRI reports. In response to the 2007 ANPRM that asked about whether the units of measure should be changed for these nutrients, we received comments that generally supported maintaining the current units of measure. We considered the IOM Labeling Committee recommendations and comments received. When expressed as ‘‘g’’ units, rather than in ‘‘mg’’ units, significant differences in the amounts of sodium or potassium could appear inconsequential or less significant. For example, amounts declared as 0.2 g and 0.5 g may not seem as significantly different as 200 mg and 500 mg. Furthermore, units of measure for these nutrients have been in use since 1993 and consumers may be already familiar with the units used on the label. In addition, the use of milligrams for sodium and potassium is consistent PO 00000 Frm 00053 Fmt 4701 Sfmt 4702 with the 2010 DGA, which provides recommendations for sodium and potassium in milligram units (Ref. 6). We tentatively conclude that there is no advantage to change the units of measure for sodium, potassium, copper, or chloride from those currently in use. Thus, we are not proposing any changes to the units used for declaring these nutrients on the Nutrition Facts label. 2. Folate and Folic Acid a. Units of Measure—The RDI for ‘‘folate’’ is listed in ‘‘micrograms’’ (§ 101.9(c)(8)(iv)). Folate represents the sum of naturally occurring folate and synthetic folic acid that has been added to foods. In 1998, the IOM set the RDA for folate expressed as mcg Dietary Folate Equivalents (DFE) (Ref. 141). The IOM Labeling Committee recommended that the units used for folate (mcg) in nutrition labeling should be consistent with the units in the new DRI report (mcg DFE) (Ref. 25). In response to the 2007 ANPRM, in which we asked for comment on this issue, a few comments supported retaining the current units (mcg) for folate and one comment noted E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11932 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules that the use of the term DFE on the label would be unfamiliar to consumers and could be confusing (Ref. 47). The IOM developed the new term, DFE, to account for the greater bioavailability of synthetic folic acid that is added to fortified foods or dietary supplements than folate that occurs naturally in foods (food folate). As defined by the IOM, mcg DFE is equivalent to mcg food folate + (1.7 × mcg synthetic folic acid) (Ref. 141). The current unit of measure (mcg) does not take into account the difference in the bioavailability of folate and folic acid. In addition, mcg DFE declaration would provide a more accurate representation of the amount of folate in foods that contain both naturally occurring folate and added folic acid. For example, the standards of identity for certain enriched foods require the addition of folic acid (21 CFR parts 136, 137, and 139) and, these foods contain both food folate and synthetic folic acid. Therefore, we are proposing to amend § 101.9(c)(8)(iv) such that mcg DFE would be used to declare the amount of total folate (food folate and synthetic folic acid) on the Nutrition Facts label. Section 101.36(b)(2)(ii)(B) for the labeling of dietary supplements includes a reference to § 101.9(c)(8)(iv), which, as proposed, designates the units of measure for declaration of folic acid as mcg DFE units (see section II.L.). We are aware that education efforts should be provided to assist with consumer understanding of the new ‘‘equivalent’’ units of measurement for folic acid. For example, using the new units, a dietary supplement that now declares 400 mcg of folic acid would declare the same amount as 680 mcg DFE or 170 percent of the proposed RDI. One option to help ensure consumer understanding would be to allow the declaration of the amount of folic acid in parenthesis similar to that permitted for the percent of vitamin A as bcarotene (§ 101.9(c)(8)(vi)). For example, for a conventional food that contains both folic acid and folate, the total mcg DFE could be declared and in parenthesis indicate how much is from folic acid. We invite comment on this approach. b. Analytical Methods—Because we are proposing to amend the units used for declaring the sum of folate and folic acid, we considered the availability and limitations of analytical methods necessary to measure each nutrient separately for calculating mcg DFE. Available analytical methods (e.g., AOAC 960.46, 944.12, and 2004.05) cannot distinguish between naturally occurring folate in conventional food and folic acid that is added to VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 conventional food products. There is a difference in folate activity between naturally occurring folate and synthetic folic acid that is added to fortify foods. When a conventional food product contains a mixture of naturally occurring folate and synthetic folic acid that has been added, available analytical methods do not allow for verification of the declared amount of mcg DFEs on the Nutrition Facts label. To calculate DFEs, it is necessary to know both the amount of folate and folic acid in the food product. Therefore, proposed § 101.9(g)(10) would require manufacturers to make and keep records to verify the amount of folic acid added to the food and folate in the finished food, when a mixture of both naturally occurring folate and added folic acid are present in the food. (See section II.N.) We invite comment on available scientifically valid methods that are capable of measuring folic acid and folate separately. c. Terms to Declare Folate—’’Folic acid’’ or ‘‘folacin’’ are identified as synonyms of folate and can be added in parentheses after folate or can be listed without parentheses in lieu of ‘‘folate’’ on the Nutrition Facts label (§ 101.9(c)(8)(v)) or in the Supplement Facts label (§ 101.36(b)(2)(B)(2)). Consistent with the proposed amendments related to the units of measure for folate that take into account the differences between folate and folic acid, we are reconsidering appropriate terms for declaration of folate content in foods and dietary supplements. We are proposing to (1) eliminate the synonym ‘‘folacin’’ specified in §§ 101.9(c)(8)(v) and 101.36(b)(2)(B)(2); (2) require, in proposed § 101.9(c)(8)(vii), that the term ‘‘folate’’ be used in the labeling of conventional foods that contain either folate only or a mixture of folate and folic acid; and (3) require that the term ‘‘folic acid’’ be used in the labeling of dietary supplements only. As proposed, conventional foods would not be permitted to use the term ‘‘folic acid.’’ 3. Vitamins A, D, and E International Units (IUs) are used for the labeling of vitamins A, D, and E on the Nutrition and Supplements Facts labels (§§ 101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B)). The IOM Labeling Committee recommended that the units for these nutrients should be changed to be consistent with the units in the new DRI reports, i.e., mg Retinol Activity Equivalents for vitamin A, mg for vitamin D, and mg a-tocopherol for vitamin E (Refs. 18,22,25,140). In response to the 2007 ANPRM, several comments supported replacing IUs with mcg RAE for vitamin A, mg for vitamin PO 00000 Frm 00054 Fmt 4701 Sfmt 4702 D, and mg a-tocopherol for vitamin E. We agree that IUs should be replaced with units that are consistent with the DRIs. In addition, because DRIs form the basis for the proposed RDIs for these vitamins (see section II.I.), using the new units would also correspond with the proposed RDIs for vitamins A, D, and E. We discuss issues relevant to vitamin A and vitamin E units of activity in this document. a. Units of Vitamin A Activity—The RDI for vitamin A is 5,000 IU (§ 101.9(c)(8)(iv)). Because the vitamin A activity of provitamin A carotenoids (e.g., b-carotene) is less than pre-formed vitamin A (retinol), the following conversions were developed: One mcg retinol = 3.33 IU vitamin A activity from retinol (Ref. 105) and 10 IU b-carotene = 3.33 IU retinol (Ref. 105). Because the vitamin A activity of b-carotene in dietary supplements is greater than bcarotene in food, ten IU of b-carotene is based on 3.33 IU of vitamin A activity × 3 (the relative vitamin A activity of bcarotene in supplements versus diets). The RDA in mcg Retinol Equivalents (RE) for vitamin A is equivalent to 1 mcg retinol or 6 mcg of b-carotene (i.e., carotene:retinol equivalency ratio of 6:1) and considers 3 mcg of dietary bcarotene to be equivalent to 1 mcg of purified b-carotene in supplements (i.e., a carotene:retinol equivalency ratio of 3:1). A comment to the 2007 ANPRM noted that the IU for vitamin A does not take into account the recent information on the bioavailability of dietary provitamin A carotenoids that was used to define retinol activity equivalents (RAEs) for these carotenoids (Ref. 105). The unit of measure associated with the RDA for vitamin A is mcg RE. We agree that the IU for vitamin A does not reflect the carotene:retinol equivalency ratio. RAEs consider 6 mcg of dietary b-carotene to be equivalent to 1 mcg of purified bcarotene in supplements (i.e., a carotene:retinol equivalency ratio of 6:1) because more recent evidence suggests that the bioavailability of b-carotene is approximately half of what was previously considered for setting mcg RE. A change in units does not present any challenges to AOAC methods used for measuring provitamin A carotenoids and vitamin A in foods or dietary supplements. Therefore, proposed § 101.9(c)(8)(iv) would change the units of measure for vitamin A to replace ‘‘IU’’ with ‘‘mcg,’’ representing mcg RAE. In addition, because the difference in the bioconversion of b-carotene to vitamin A will be accounted for with the proposed declaration of vitamin A content as ‘‘mcg’’ (representing mcg E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules RAE), we are not proposing to preclude the declaration of b-carotene in conventional foods as vitamin A. A corresponding change for dietary supplements is made in proposed § 101.36(b)(2)(i)(B)(3). b. Units of Vitamin E Activity—The RDI for vitamin E is 30 IU (§ 101.9(c)(8)(iv)). Before 1980, one IU of vitamin E activity was defined as 1 mg of dl-a-tocopherol acetate by the U.S. Pharmacopeia (USP) (Ref. 142). After 1980, the IU was changed to the USP unit where one USP unit of vitamin E was still defined as having 1 mg of all rac-a-tocopherol acetate. Therefore there is no longer an IU for vitamin E (Ref. 142). One comment to the 2007 ANPRM said that the current RDI of 30 IU underestimates the amount of vitamin E naturally present in foods. We agree. The RDA for vitamin E is 15 mg/ d of a-tocopherol (Ref. 143). aTocopherol is the only form of vitamin E that is maintained in blood and has biological activity. There are eight stereoisomers of a-tocopherol (RRR, RSR, RRS, RSS, SRR, SSR, SRS, SSS). Of the eight, only RRR a-tocopherol occurs naturally in foods. Commercially available vitamin E that is used to fortify foods and used in dietary supplements contains esters of either the natural RRR- or, more commonly, mixtures of the 8 stereoisomers (all rac a-tocopherol acetate). Four of the eight stereoisomers of a-tocopherol are not maintained in human plasma or tissues (SRR, SSR, SRS, and SSS). Thus, the new RDA for vitamin E is limited to the four 2R stereoisomeric forms (RRR, RSR, RRS and RSS) of a-tocopherol (Ref. 143). These four forms of a-tocopherol are found in nonfortified and fortified conventional foods and dietary supplements. The all rac-a-tocopherol acetate in fortified foods or dietary supplements has one-half the activity of RRR-a-tocopherol naturally found in foods or the 2R stereoisomeric forms of a-tocopherol. Unlike the IU, the new IOM measure of vitamin E activity, mg a-tocopherol accounts for this difference in activity between naturally occurring and synthetic vitamin E. Therefore, proposed § 101.9(c)(8)(iv) would change the units of measure for vitamin E to replace ‘‘IU’’ with ‘‘mg,’’ representing mg of a-tocopherol. Section 101.36(b)(2)(ii)(B) for the labeling of dietary supplements includes a reference to § 101.9(c)(8)(iv), which, as proposed, designates the units of measure for declaration of vitamin E as ‘‘mg.’’ Because of the difference in vitamin E activity between all rac-a-tocopherol acetate and RRR-a-tocopherol, AOAC methods or other validated analytical VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 methods would be needed for individually measuring naturally occurring vitamin E (RRR-a-tocopherol) and all rac-a-tocopherol acetate in food products. Current AOAC methods cannot individually measure these two forms of vitamin E. In addition, it is necessary to know the amount of both RRR-a-tocopherol and all rac-atocopherol acetate in a food product to calculate vitamin E equivalents for declaration as mg a-tocopherol. It is not possible to determine the amount of RRR-a-tocopherol in a food product by subtracting the amount of all rac-atocopherol acetate from the total amount of vitamin E declared. Therefore, when a conventional food contains a mixture of all rac-a-tocopherol acetate and RRRa-tocopherol, we are proposing to require manufacturers to verify the declared amount of both all rac-atocopherol acetate and RRR-atocopherol in the finished food product (proposed § 101. 9(g)(10)). (See section II.N.) We invite comment on available validated methods that are capable of individually measuring all rac-atocopherol acetate and RRR-atocopherol. For the reasons stated previously, we are proposing to amend § 101.9(c)(8)(iv) to replace IUs for the RDIs for vitamin A, vitamin D, and vitamin E with mcg RAE for vitamin A, mg for vitamin D, and mg a-tocopherol for vitamin E. K. Labeling of Foods for Infants, Young Children, and Pregnant or Lactating Women The general labeling requirements for foods in § 101.9(c) apply to foods for infants, young children, and pregnant and lactating women with certain exceptions. For example, foods, other than infant formula, represented or purported to be specifically for infants and children less than 4 years of age are not permitted to include declarations of percent DV for the following nutrients: Total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate and dietary fiber (§ 101.9(j)(5)(ii)(A)). There are additional exceptions to labeling for foods, other than infant formula, represented or purported to be specifically for infants and children less than 2 years of age. For example, these foods are also not permitted to declare calories from fat, calories from saturated fat, saturated fat, polyunsaturated fat, monounsaturated fat and cholesterol on the Nutrition Facts label (§ 101.9(j)(5)(i)). FDA regulations do not include DRVs or RDIs for nutrients, generally, for infants, children under 4 years of age, or pregnant and lactating women. However, there are requirements for a PO 00000 Frm 00055 Fmt 4701 Sfmt 4702 11933 DRV for protein for children 4 or more years of age, and an RDI for protein for each of the following subpopulations: (1) Children less than 4 years of age; (2) infants; (3) pregnant women; and (4) lactating women (§ 101.9(c)(7)(iii)). In the preamble to the 1993 DRV/RDI final rule, we included a table listing RDIs for various nutrients for these subpopulations, based on the 1968 NAS RDAs (58 FR 2206 at 2213). These RDIs also appear in FDA’s Food Labeling Guide (Ref. 144) and we are aware that some manufacturers use these RDIs in labeling foods represented or purported to be specifically for these subpopulations. We are reconsidering the requirements for the labeling of foods, other than infant formula, represented or purported to be specifically for infants, children under 4 years of age, and pregnant and lactating women, in light of current recommendations in consensus reports and proposed changes to the Nutrition Facts label discussed in sections II.A. to II.J., and comments to the 2007 ANPRM. We are proposing various changes, which we discuss in this document. 1. Age Range for Infants and Young Children FDA regulations use the age ranges ‘‘less than 2 years of age’’ and ‘‘less than 4 years of age’’ to establish labeling requirements for foods represented or purported to be specifically for infants and young children (§ 101.9(j)(5)). The 2007 ANPRM did not ask for comments on this issue, but several comments (Ref. 47) recommended that we change the current age categories to infants 7 to 12 months and young children 1 through 3 years (13 through 48 months), consistent with the age ranges used in the IOM’s age-specific DRI recommendations. In general, we consider it appropriate to adopt the same age categories as those used in the IOM DRIs for infants and children because our proposed DVs are based on these age-specific DRIs. With respect to the infant category, the nutritional requirements of infants 0 to 6 months should be met almost exclusively by breast milk or infant formula (Refs. 145 and 146). Therefore, regulations for the labeling of foods, other than infant formula, represented or purported to be specifically for infants 0 to 6 months of age are not necessary or appropriate. However, infants are transitioning to eating solid foods by 7 through 12 months. There are a number of foods in the marketplace identified for this age group. Therefore, we are proposing a separate category of foods represented or purported to be E:\FR\FM\03MRP2.SGM 03MRP2 11934 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules specifically for infants 7 through 12 months. With respect to children 1 through 3 years of age, using the DRI age range would result in infants no longer being the lower end of the age range in the category of infants and children less than 2 years and less than 4 years of age as specified in § 101.9(j)(5). Young children who are 1 year of age would be the lower end of the age range. Assigning DVs for children 1 through 3 years of age would ensure consistency with the 1 through 3 year toddler age category established for RACCs specified in § 101.12(a)(2). Moreover, because the growth velocity in height is most similar for children 1 through 3 years of age, we consider it appropriate to revise the age range to include children of these ages into a single category for food labeling purposes (Ref. 15). Therefore, we are proposing to revise the exceptions for requirements for nutrition labeling provided in § 101.9(j)(5)(i) and the exception to the requirement for the format used for nutrient information on food labeling in § 101.9(d)(1) for foods represented or purported to be specifically for infants and children less than 4 years of age. Specifically, we are proposing to replace the current category of infants and children less than 4 years with infants 7 through 12 months and children 1 through 3 years of age. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 2. Mandatory Declaration of Calories and Statutorily Required Nutrients Currently, foods, other than infant formula, represented or purported to be specifically for infants and children less than 4 years must declare statutorily required nutrients, including calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, sugars, dietary fiber, and protein. For foods, other than infant formula, represented or purported to be for infants and children less than 2 years, the declaration of certain statutorily required nutrients, which include calories from fat, saturated fat, and cholesterol, is not required or permitted (§ 101.9(j)(5)(i)). a. Declaration of Saturated Fat and Cholesterol—One comment to the 2007 ANPRM noted that the diet of U.S. infants is nutritionally adequate with negligible risk of nutrient deficiency and recommended continuing to require the declaration of calories and the amount of total fat, total carbohydrate, dietary fiber, sugars, and total protein on the Nutrition Facts label of foods for infants. Another comment supported mandatory declaration of saturated fat VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 on food products for children less than 2 years of age. As discussed in section II.K.1., we are proposing new categories of infants 7 through 12 months and children 1 through 3 years of age. We are considering, in this proposed rule, whether there is a need to require or permit the declaration of calories from fat, saturated fat, and cholesterol in the labeling for foods represented or purported to be specifically for these subpopulations. In section II.A.1., we discuss our intent to revise § 101.9(c)(1)(ii) to no longer require and not permit the declaration of calories from fat on the Nutrition Fact label. Therefore, if these proposed changes are finalized, the exceptions in § 101.9(j)(5)(i) would no longer be needed. With respect to saturated fat and cholesterol, we did not require or permit the labeling of any fat or fatty acid on foods represented or purported to be specifically for children less than 2 years because consensus reports noted the need for the higher percentage of calories from fat for this subpopulation and that nutrient guidelines on fats, cholesterol and calories for children less than 2 years of age is inappropriate (58 FR 2079 at 2150). A recent consensus report continues to recommend that fat intake in infants less than 12 months of age should not be restricted; however, there is no discussion or recommendation about not providing nutrient guidelines for fat and cholesterol to children under the age of 2 years (Ref. 146). While fat is still considered to be an important source of calories for infants and young children, recent evidence suggests that a diet with saturated fat less than 10 percent of calories and cholesterol intake less than 300 mg/d can safely and effectively reduce the levels of total and LDL cholesterol in healthy children (Ref. 146). This type of diet may have similar effects when started in infancy and sustained throughout childhood into adolescence (Ref. 146). Furthermore, the 2010 DGA recommended that Americans 2 years of age and older consume less saturated fatty acids and less than 300 mg/d of cholesterol (Ref. 6). We tentatively conclude that, except for the declaration of calories from fat, the declaration of statutorily required nutrients that include saturated fat and cholesterol on the label of foods represented or purported to be specifically for infants 7 through 12 months and children 1 through 3 years of age should be mandatory because: (1) The declaration of calories and these nutrients is mandated by section 403(q) PO 00000 Frm 00056 Fmt 4701 Sfmt 4702 of the FD&C Act and we have no basis on which to not require or permit their declaration as discussed previously; and (2) these nutrients are essential in fostering growth and maintaining good health during a critical stage of human development and physiology (Ref. 147 p. 71) and, therefore, their mandatory declaration can assist in maintaining healthy dietary practices. Therefore, we are proposing to remove current § 101.9(j)(5)(i) and revise and redesignate current § 101.9(j)(5)(ii) as § 101.9(j)(5)(i). We request comment on our tentative conclusions and any available relevant empirical research as to whether the proposed declaration of saturated fat and cholesterol for these subpopulations is likely to be confusing to consumers or otherwise result in restriction of fat intakes among infants 7 through 12 months or children 1 through 3 years of age. Currently, foods consumed by pregnant and lactating women must declare statutorily required nutrients, including calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, sugars, dietary fiber, and protein. Women of reproductive age consume the same foods as the general population and, in general, continue consuming similar foods during pregnancy and lactation. We tentatively conclude that, except for the declaration of calories from fat, the declaration of statutorily required nutrients should be mandatory because the declaration of calories and these nutrients is mandated by section 403(q) of the FD&C Act and we have no basis on which to not require or permit their declaration as discussed previously. Accordingly, we are proposing to require the mandatory declaration of calories, and the amount of total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, and protein on foods represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women, and permit the declaration of calories from saturated fat such that these nutrients would be subject to the same requirements applicable to foods for the general population. A comment to the 2007 ANPRM requested that we permit the use of a footnote statement about not limiting fat intake on foods represented or purported to be specifically for infants and children less than 2 years to enable consumers to make informed choices, should the Agency decide to propose the mandatory declaration of saturated fat for infants and children less than 2 E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules years. The comment noted that saturated fat should not be limited in the diets of children less than 2 years of age. The comment provided no consumer data about such a footnote statement. At this time, we are not proposing to require a footnote stating that total fat and other types of fat should not be limited in infants and children less than 2 years in response to this comment. However, we request comments and information on how consumers would understand and use the amount of saturated fat and cholesterol declared on the Nutrition Facts label, as well as on the need for an explanatory footnote to accompany the declaration of saturated fat and cholesterol, on foods represented or purported to be specifically for infants 7 through 12 months or children 1 through 3 years. b. Percent DV Declaration—Currently, the percent DV declaration is not permitted on the food label for foods, other than infant formula, represented or purported to be specifically for infants and children less than 4 years (which includes infants and children less than 2 years) for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber (§ 101.9(j)(5)(ii)). Percent DV is required for protein and vitamins and other minerals. We tentatively conclude that it is appropriate to require declarations of percent DV for those nutrients for which we are establishing a DRV or RDI for infants 7 to 12 months, for children 1 through 3 years of age, and for pregnant and lactating women (see the discussion in this document for the nutrients in each subpopulation for which FDA is establishing a DRV or RDI). This change is reflected in redesignated § 101.9(j)(5)(i). The percent DV, as discussed in section II.B.3., provides information in a manner which enables consumers to understand the relative significance of nutrition information in the context of a total daily diet. One comment to the 2007 ANPRM suggested that the percent DV declaration for protein should be voluntary for all infant products, unless a claim is made for protein because protein intake and quality appear to be adequate for infants (Refs. 148 and 149). As we previously stated, protein is of critical importance in maintaining good health because it supplies essential amino acids and is a principal source of calories along with fat and carbohydrate (55 FR 29487 at 29499). Current evidence suggests that protein intake is adequate in infants and young children and the majority of protein sources in their diets constitute high quality VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 protein sources (Ref. 150). However, the level and quality of protein present in a food remain an important consideration in food selection for infants because infant diets are derived from a limited number of foods (55 FR 29487 at 29499). For example, at 6 to 11 months of age, approximately 46 percent of the total protein intake comes from sources other than breast milk, formula, and cow’s milk (e.g., baby foods and meats) (Ref. 149). The percentage increases at ages 12 to 24 months to 63 percent (Ref. 149). Calculating the percent DV for protein incorporates a measure of protein quality (e.g., a corrected protein amount obtained from the protein digestibilitycorrected amino acid score) (§ 101.9 (c)(7)(i)). Thus, the percent DV declaration is a useful tool to indicate protein quality to the consumer. As such, we disagree that the percent DV declaration for protein should be voluntary. Because of the importance of adequate high quality protein in the diets of infants and young children, we tentatively conclude that the percent DV declaration for protein is necessary to assist consumers in maintaining healthy dietary practices among infants and young children 1 through 3 years of age. 3. Declaration of Non-Statutory Nutrients Other Than Essential Vitamins and Minerals Foods, other than infant formula, represented or purported to be specifically for infants and children less than 2 years of age are not permitted to declare calories from saturated fat and the amount of polyunsaturated fat and monounsaturated fat (§ 101.9(j)(5)(i)), whereas soluble fiber, insoluble fiber, and sugar alcohols can be voluntarily declared. Polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohols can be voluntarily declared on the label of foods represented or purported to be specifically for children 2 through 4 years of age, and pregnant and lactating women. Section I.C. includes a discussion of the factors that we consider in proposing the requirements for declaration of non-statutorily required nutrients on the Nutrition Facts label of foods (e.g., polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohols). These factors include the availability of information from consensus reports, including evidence for the public health significance of a nutrient. Consensus reports that provide information about the relationship between nutrients and chronic diseases, heath-related conditions, or health-related PO 00000 Frm 00057 Fmt 4701 Sfmt 4702 11935 physiological endpoints are generally not available for infants 7 to 12 months. Therefore, for foods represented or purported to be for these infants, we are not considering consensus reports in the way described in section I.C., but, rather, we are considering other types of information that are available from consensus reports applicable to this subpopulation. With respect to certain nutrition declaration requirements, we determined there was not sufficient evidence to propose a change to the regulations. In addition, we determined that, in some cases, there is not sufficient evidence to propose different requirements for foods represented or purported to be specifically for infants 7 through 12 months than for foods represented or purported to be specifically for children 1 through 3 years of age. For foods represented or purported to be specifically for children 1 through 3 years of age and pregnant and lactating women, we considered the factors in section I.C. to determine whether to propose the mandatory or voluntary declaration of non-statutory nutrients. Most advisory consensus and policy reports on which we rely for the general population apply to children 2 years of age and older and pregnant and lactating women, unless noted otherwise (e.g., 2010 DGAC and health claims (§ 101.14(e)(5)). While the recommendations in these reports are for 2 years of age and older, we are using the information in these consensus reports for considering the factors in section I.C. for children 1 through 3 years of age because it is not expected that the role of these nutrients in health would be markedly different between 1 and 2 year olds. Moreover, the IOM has established the DRI ranges for 1 to 3 year olds. a. Voluntary Declaration of Calories From Saturated Fat, and the Amount of Polyunsaturated and Monounsaturated Fat—For infants 7 to 12 months, there are no specific recommendations provided about calories from saturated or polyunsaturated or monounsaturated fat. However, as discussed previously, there is some evidence to suggest that reduction of total and LDL cholesterol levels can occur with reducing saturated fat intake to less than 10 percent of calories, beginning in infancy and sustained throughout childhood into adolescence (Ref. 146). Furthermore, consensus reports provide no discussion or recommendation about not providing nutrient guidelines for fatty acids to children under the age of 2 years and there is no evidence to suggest that infants 7 through 12 months of age would be different than children 1 E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11936 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules through 3 years of age. Therefore, we tentatively conclude that there is no basis to continue to provide an exception that does not permit the declaration of calories from saturated fat, or polyunsaturated and monounsaturated fats on foods represented or purported to be specifically for infants and children less than 2 years of age. Quantitative intake recommendations are not available from relevant U.S. consensus reports for monounsaturated and polyunsaturated fats for children 1 through 3 years of age or pregnant and lactating women. There is wellestablished evidence to indicate that replacing saturated fatty acids with polyunsaturated and monounsaturated fatty acids reduces blood LDL cholesterol levels and, therefore, the risk of CVD (Ref. 6). Because monounsaturated and polyunsaturated fats have public health significance when they replace saturated fat, consistent with the factors we consider for voluntary declaration discussed in section I.C., we tentatively conclude that not permitting the declaration of polyunsaturated and monounsaturated fat on foods represented or purported to be specifically for children less than 2 years of age in § 101.9(j)(5)(i) is no longer necessary. Therefore, we are proposing to revise § 101.9(j)(5)(i) to remove the exceptions for the declaration of calories from saturated fat, and the amount of polyunsaturated fat and monounsaturated fat on foods represented or purported to be specifically for children less than 2 years of age. If finalized, these declarations would be the same as the proposed voluntary declarations for foods for the general population (see sections II.A.2, II.B.4, and II.B.5., respectively). b. Voluntary Declaration of Soluble Fiber, Insoluble Fiber, and Sugar Alcohols—As discussed in section II.D., while quantitative intake recommendations are lacking for soluble fiber, insoluble fiber, and sugar alcohols, there is well established evidence for the role of these nutrients in chronic disease risk, risk of a healthrelated or a physiological endpoint (i.e., CHD, laxation or dental caries) (Ref. 66 and §§ 101.76, 101.77, 101.80, and 101.81). There is no evidence to suggest that the role of these nutrients would be different among infants 7 through 12 months, children 1 through 3 years of age, or pregnant and lactating women compared to the general population. Accordingly, we are not proposing any changes to the provisions for the voluntary declaration of soluble fiber, VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 insoluble fiber, and sugar alcohols on the label of foods represented or purported to be specifically for infants 7 to 12 months, children 1 through 3 years of age, or pregnant and lactating women. c. Mandatory Declaration of Trans Fat—Trans fat is required to be declared on the Nutrition Facts label and regulations do not provide exceptions for foods represented or purported to be specifically for infants, young children, or pregnant and lactating women. One comment to the 2007 ANPRM recommended eliminating mandatory trans fat labeling when total fat is declared as 0 g in the Nutrition Facts label of foods for infants. As explained in section II.B.3., we are not proposing any changes to the mandatory declaration of trans fat in the labeling of foods intended for the general population. The relationship between the consumption of trans fat and risk of CHD is well established (Refs. 6 and 49). Cardiovascular disease is also known to begin in childhood (Refs. 146 and 151). Thus, we tentatively conclude that declaration of trans fat continues to be necessary to assist consumers in maintaining health dietary practices, including among infants, young children, and pregnant and lactating women. Trans fat declaration is voluntary when the total fat content of a food is less than 0.5 g (§ 101.9(c)(2)(ii)). In addition, if a manufacturer does not declare the trans fat content because total fat amount is less than 0.5 g, then the statement ‘‘Not a significant source of trans fat’’ must be placed at the bottom of the table of nutrient values. This statement indicates why information that is required to be declared is omitted and provides necessary information to assist in making healthy dietary choices (55 FR 29487 at 29502). The statement is also helpful in minimizing space requirements for labels that do not meet the simplified label format requirements (58 FR 2079 at 2084). Therefore, we are not proposing any changes to the mandatory declaration of trans fat on the label of foods represented or purported to be specifically for infants, children 1 through 3 years of age, or pregnant and lactating women. d. Mandatory Declaration of Added Sugars—Whereas FDA regulations do not provide for the declaration of added sugars on the Nutrition Facts label, as explained in section II.D.3., we are proposing to require the mandatory declaration of added sugars on the Nutrition Facts label. The 2010 DGA provides recommendations for PO 00000 Frm 00058 Fmt 4701 Sfmt 4702 consumption of added sugars for the U.S. population 2 years of age and older, but not for infants and children under age two. However, we would not expect the recommendations for added sugars for a 2 year old to be different from that of a 1 year old because we do not expect the role of added sugars in health to be markedly different between children 1 and 2 year olds. Moreover, the IOM has established DRI ranges for 1 through 3 year olds because growth velocity is most similar during this age range (Ref. 15). Further, mandatory declaration of added sugars would be important for foods for infants 7 through 12 months, as it is for the general population, to assist consumers in choosing nutrientdense foods for infants 7 through 12 months during this phase of accelerated growth and development. Moreover, we do not have any information that providing added sugars information on the Nutrition Facts label of foods marketed to the subpopulations of infants 7 through 12 months and children 1 to 3 years of age would not assist in maintaining healthy dietary practices. Therefore, we are proposing the mandatory declaration of added sugars on the Nutrition Facts label of foods represented or purported to be specifically for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women. We request comment on our tentative conclusion. e. Voluntary Declaration of Fluoride— FDA regulations do not provide for the declaration of fluoride on the Nutrition Facts label of any foods. For the reasons discussed in section II.G., we are proposing to permit voluntary declaration of fluoride on the labeling of foods for the general population based on the factors we consider in section I.C. and fluoride’s role in reducing the risk of dental caries. Because fluoride provides protection against dental caries by strengthening the tooth enamel before and after teeth appear (Ref. 90) and because excessive fluoride intake can cause dental fluorosis in young children (Ref. 92), we tentatively conclude that the declaration of fluoride on foods represented or purported to be specifically for children 1 through 3 years of age, and pregnant and lactating women can assist in maintaining healthy dietary practices. While evidence on dental caries is lacking for infants 7 through 12 months of age, there is no reason to expect the role of fluoride in the protection against dental caries to be different from other age groups. Therefore, proposed § 101.9(c)(5) would permit the voluntary declaration of fluoride on foods E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women. 4. Declaration of Essential Vitamins and Minerals The declarations of vitamin A, vitamin C, calcium, and iron are required on the Nutrition Facts label, and there are no specific exceptions to this requirement for foods represented or purported to be specifically for infants and children less than 2 years and children less than 4 years of age, and pregnant and lactating women. We considered the factors for mandatory and voluntary declaration of nutrients discussed in section I.C., as applicable, to determine whether to propose to require or permit certain vitamins and minerals in the labeling of foods for infants, children, and pregnant and lactating women. The AIs for essential vitamins and minerals (and RDAs for iron and zinc) for infants 7 to 12 months of age are based on the average intake of nutrients that infants consumed from breast milk, complementary foods, and/or supplements with the understanding that these sources provided sufficient amounts of the nutrients to meet the infant’s daily needs (Refs. 18, 22, and 23). Therefore, the AIs (as well as the RDAs for iron and zinc) for infants were not based on endpoints related to chronic disease risk, or a health-related conditions or health-related physiology. Furthermore, because the AI represents intakes that are considered adequate and are based on average nutrient intakes from breast milk, foods, and/or supplements, the presence of an AI indicates that there is not a public health concern about adequate intake of that nutrient. Therefore, we could not determine public health significance for a nutrient during infancy based on an AI for infants. Instead, we considered the importance of the nutrient in establishing healthy dietary practices during infancy for later in life, as well as the relevant available information for children 1 through 3 months of age that may also be applicable to infants. For nutrients with an RDA for infants 7 through 12 months of age (i.e., iron and zinc), we considered the factors for mandatory and voluntary labeling described in section I.C. to determine whether to propose mandatory or voluntary labeling for the nutrient. For the declaration of essential vitamins and minerals for children 1 through 3 years of age and pregnant and lactating women, we propose the same considerations based on the same VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 rationale as we set forth and proposed for the general population because scientific and policy considerations are generally the same and the DGA recommendations apply to Americans 2 years of age and older. While NHANES data were collected in lactating women, these data are not included in our analysis in this document because the sample size of lactating women was small and, thus, we could not reliably estimate mean intake and status of this population. However, the conclusions made about nutrient inadequacy during pregnancy are applied to lactating women since the needs of essential vitamin and minerals are increased for both pregnant and lactating women. Therefore, we are proposing the requirements related to essential vitamins and minerals in the labeling of foods for pregnant women and those for foods for lactating women should be the same. Accordingly, we are proposing to remove the provision in § 101.9(c)(8)(i) that requires separate declaration of percent DVs based on both RDI values for pregnant women and for lactating women in the labeling of foods represented or purported to be for use by both pregnant and lactating women. We did not ask questions related to this issue in the 2007 ANPRM, but received some comments which we considered in reaching our tentative conclusions discussed in this document. a. Mandatory Declaration of Calcium and Iron—We are not proposing any changes to the mandatory declaration of calcium on foods for the general population (see section II.H.1.). The AI for calcium for infants 7 through 12 months of age is based on average calcium consumption of these nutrients, rather than chronic disease risk, health related-condition, or physiological endpoints (Ref. 152). For children 1 through 3 years of age, and pregnant and lactating women, the RDAs for calcium are based, in part, on bone health (Ref. 22). One comment to the 2007 ANPRM recommended mandatory declaration of calcium and iron for labeling of foods for young children. Our analysis of NHANES 2003–2006 data estimated that infants ages 7 to 12 months have usual calcium intakes above the AI (table 3). Our analysis of NHANES 2003–2006 estimated that about 12 percent of children 1 through 3 years of age had usual intakes of calcium below the EAR, based on intakes from conventional foods only (table 4). The percentage did not change when supplements were included. We are unable to consider biomarker data because sensitive biochemical indicators reflecting calcium nutritional status are lacking. Promoting the PO 00000 Frm 00059 Fmt 4701 Sfmt 4702 11937 development of eating patterns that are associated with adequate calcium intake later in life is important (Ref. 153) given that calcium intakes are inadequate for the majority of the population (see table 1). Intakes of calcium, which is necessary for growth and bone development, are inadequate among children. Similar to the general population, approximately 20 percent of pregnant women consumed less than the EAR for calcium from conventional foods as well as from conventional foods and supplements (table 5). Consistent with the factors we consider for essential vitamins and minerals (see section I.C.), we tentatively conclude that calcium is a nutrient of public health significance for children 1 through 3 years of age, and pregnant and lactating women. Because calcium is important for growth and development, we tentatively conclude that calcium is of public health significance for infants 7 through 12 months of age. As such, we agree with the comment that recommended mandatory declaration of calcium for foods purported to be specifically for young children. We are not proposing any changes to the mandatory declaration of iron on foods for the general population (see section II.H.1.). Although the EAR and RDA are based on daily iron requirements and not directly on chronic disease risk, iron deficiency is associated with delayed normal infant motor function (i.e., normal activity and movement) and mental function (i.e., normal thinking and processing skills) (Ref. 100). Our analysis of NHANES 2003–2006 data estimated that about 18 percent of infants ages 7 to 12 months have usual iron intakes below the EAR, based on intakes from conventional foods only and 4 percent of infants ages 7 to 12 months have usual iron intakes below the EAR based on intakes from conventional foods and supplements (table 3). For children 1 through 3 years of age, about 1 percent of children have usual iron intakes below the EAR, based on intakes from conventional foods only and 0.4 percent of children have usual iron intakes below the EAR based on intakes from conventional foods and supplements (table 4). The IOM set the EAR by modeling components of iron requirements. While total iron intakes appear adequate, the prevalence of iron deficiency in children ages 1 to 2 years has been reported to be 14.4 percent and the prevalence of iron deficiency anemia in children younger than 5 years has been reported to be 14.9 percent (Refs. 74 and 154). Therefore, we agree with the comment that recommended E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11938 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mandatory declaration of iron in the labeling of foods for young children. Inadequate iron intakes during pregnancy are also of public health significance because of the adverse effects for both the mother and the fetus (such as maternal anemia, premature delivery, low birth weight, and increased perinatal infant mortality) (Ref. 15). Our analysis of data collected by NHANES 2003–2006 estimated that 5 percent of pregnant women 14 to 50 years of age had usual iron intakes below the EAR based on intakes from conventional foods and 4 percent of pregnant women 14 to 50 years of age had usual iron intakes below the EAR based on intakes from conventional foods and supplements (table 5). The EAR for iron for pregnant women was based on estimates of iron stores needed during the first trimester (Ref. 100). Our analysis of 2003–2006 NHANES data indicate that among pregnant women aged 12 to 49 years, 25 percent were iron deficient and 13 percent had iron deficiency anemia. For the purpose of this analysis, iron deficiency was based on two out of three cutoffs of iron deficiency variables (transferrin saturation, serum ferritin, and erythrocyte protoporphyrin) (Ref. 155). While intakes appear adequate for most individuals, the prevalence of iron deficiency and iron deficiency anemia indicates that iron deficiency is of public health significance for pregnant women. As discussed in section II.H.1., iron is of public health significance for women of childbearing age. Therefore, we tentatively conclude that iron is a nutrient of public health significance for lactating women as well. Because calcium and iron have quantitative intake recommendations and are considered to have public health significance for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women, we tentatively conclude that the declaration of calcium and iron is necessary to assist consumers in maintaining healthy dietary practices. Accordingly, proposed § 101.9(c)(8)(ii) would require the mandatory declaration of calcium and iron on foods represented or purported to be specifically for infants 7 to 12 months, children 1 through 3 years of age, or pregnant and lactating women; we are not providing for any exceptions for these subpopulations from the requirement for declaration of calcium and iron applicable to foods for the general population. b. Mandatory Declaration of Vitamin D and Potassium—We are proposing to require the declaration of vitamin D on foods for the general population (see VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 section II.H.1.). The AI for vitamin D for infants was based on maintenance of serum 25(OH)D concentrations at a level to achieve and maintain serum 25(OH)D concentrations above a defined level (30 to 50 nmol/L) in order to meet the needs of the majority of the infants and support bone accretion (Ref. 22). DRIs (EAR and RDA) for vitamin D were established at a level to achieve and maintain serum 25(OH)D concentrations above a defined level (40 to 50 nmol/L) in order to maintain bone health for children 1 through 3 years of age and pregnant women (Ref. 22). Serum 25(OH)D data were not available in NHANES 2003–2006 for infants ages 7 to 12 months. Our analysis of NHANES 2003–2006 dietary data shows that 28.7 and 33.6 percent of infants ages 7 to 12 months have usual vitamin D intakes above the AI from conventional foods and conventional foods plus supplements, respectively (table 3). Our analysis of NHANES 2003–2006 data shows that about 3 percent of children 1 through 3 years of age had serum 25(OH)D levels below 40 nmol/L (a level set by IOM as equivalent to EAR, see section II.H.2.a). Analysis of NHANES 2005–2008 dietary data shows that, assuming minimal sun exposure, about 82 percent of these children had usual vitamin D intakes below the EAR from conventional foods only and 66 percent had usual intakes below the EAR from conventional foods and supplements (table 4). For pregnant women, 15 percent had serum 25(OH)D levels below 40 nmol/L, while about 88 percent of pregnant women had usual vitamin D intakes below the EAR from conventional foods only and 48 percent had usual intakes below the EAR from conventional foods and supplements (table 5). In addition to data on vitamin D status and intake, we considered other scientific and policy considerations, such as the importance of the nutrient in establishing healthy dietary practices for later life for children 1 through 3 years of age and pregnant and lactating women. Vitamin D has a role in bone health through calcium absorption and uptake by bones (Ref. 22). Deficiency results in inadequate bone mineralization or demineralization of the skeleton including rickets, osteomalacia, and osteoporosis (Ref. 22). Therefore, we tentatively conclude that vitamin D has public health significance in children 1 through 3 years of age and pregnant women based on the high prevalence of inadequate intakes of vitamin D and its important role in bone development and health (Ref. 22). In addition, in 2008, we authorized a health claim for calcium and vitamin D PO 00000 Frm 00060 Fmt 4701 Sfmt 4702 intake and reduced risk of osteoporosis (§ 101.72), signifying vitamin D’s critical role in the risk reduction of this chronic disease for individuals 2 years of age and older. We also tentatively conclude that vitamin D is of public health significance for infants 7 through 12 months of age based on its importance for growth and development during infancy. We are proposing to require the declaration of potassium on foods for the general population (see proposed § 101.9(c)(8)(ii) and section II.H.1.). The AI for infants is based on average potassium intake from breast milk and/or complementary foods. The AI for the other life-stage and gender groups is set at a level to maintain blood pressure, reduce the adverse effects of sodium chloride intake on blood pressure, and reduce the risk of recurrent kidney stones (Ref. 21). Our analysis of NHANES 2003–2006 shows that 99 percent of infants ages 7 to 12 months have usual potassium intakes above the AI (table 3). Only 7 percent of children 1 through 3 years of age (table 4) and 4 percent of pregnant women (table 5) had usual potassium intakes above the AI from conventional foods or conventional foods plus dietary supplements, indicating that the adequacy of intakes is very low. In the absence of a sensitive biochemical indicator of potassium nutritional status, we could not consider biomarker data to inform the determination of prevalence of potassium deficiency. In 2000, a FDAMA notification for a health claim about potassium, blood pressure, and stroke was submitted to us under section 403(r)(2)(g) of the FD&C Act (Ref. 114). Foods may bear the following claim ‘‘Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke,’’ on the label or labeling of any food product that meets the eligibility criteria described in the notification and meets the general requirements for a health claim (§ 101.14(e)(6)). This health claim pertains to the general population 2 years of age and older. Thus, we recognize the importance of potassium in the risk reduction of these chronic diseases for children 2 years of age and older. Therefore, we tentatively conclude that potassium is of public health significance to children 1 through 3 years of age, and pregnant and lactating women. We have no basis to conclude that the public health significance of potassium among infants 7 through 12 months of age would be different than the science-based evidence for children 1 through 3 years of age and consider it important to E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules establish healthy dietary practices for later life. Because of the benefits of adequate potassium intake in lowering blood pressure, data indicating low likelihood of potassium adequacy, and importance of establishing healthy dietary practices for later life, we tentatively conclude that potassium is a nutrient of public health significance for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women. We are proposing to require the labeling of vitamin D and potassium on foods represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, or pregnant and lactating women based on the quantitative intake recommendations for vitamin D and potassium and the public health significance of these nutrients. Consequently, we are not providing for any exceptions for these subpopulations from the general requirement for declaration of vitamin D and potassium in proposed § 101.9(c)(8)(ii). c. Voluntary Declaration of Vitamin A and Vitamin C—We are proposing to no longer require the declaration of vitamin A and vitamin C on foods for the general population (see section II.H.1.). None of the DRIs (AIs or RDAs) for vitamin A were based on chronic disease risk, a health related-condition, or healthrelated physiological endpoints. One comment to the 2007 ANPRM stated that intakes of vitamins A and C among young children appear to be adequate (Ref. 148) and supported voluntary declaration of these nutrients in the labeling of foods for this subpopulation. Our analysis of data from NHANES 2003–2006 shows that less than 2 percent of children had usual vitamin A intakes below the EAR from conventional foods or conventional foods plus dietary supplements (table 4). While 36 percent of pregnant women had usual intakes below the EAR from conventional foods and 22 percent had usual intakes below the EAR for conventional foods plus dietary supplements, only 1 percent of these women had serum vitamin A levels that were considered to be indicative of a vitamin A deficiency (table 5). While quantitative intake recommendations are available for vitamins A and C, neither of these vitamins is considered to have public health significance for children 1 through 3 years of age and pregnant women. There is a very low prevalence of inadequate intakes of vitamins A and C or inadequate status among children 1 through 3 years of age or pregnant women, and we have no evidence to indicate that this would be different for VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 infants or lactating women. Therefore, we tentatively conclude that vitamin A and vitamin C are not of public health significance among infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women. Thus, we agree with a comment that supported voluntary declaration of vitamins A and C in the labeling of foods for young children. An AI for older infants was provided by the IOM with the assumption that vitamin A and vitamin C intakes are adequate during infancy. Accordingly, similar to our proposal for voluntary declaration of vitamins A and C in the labeling of foods for the general population, we are proposing to permit, but not require, the declaration of vitamin A and vitamin C on foods represented and purported to be specifically for infants 7 through 12 months, children 1 through 3 years of age, or pregnant and lactating women. As for other voluntary nutrients, the declaration of these nutrients would be required when these nutrients are added as nutrient supplements or claims are made about them (proposed § 101.9(c)(8)(ii)). d. Voluntary Declaration of Other Vitamins and Minerals—As discussed in section II.H.3., for the general population, we are proposing to permit the voluntary declaration of vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and choline (proposed § 101.9(c)(8)(ii)). Vitamins and minerals other than iron, calcium, vitamin D and potassium for infants either have DRIs that are not based on chronic disease risk, heath-related conditions, or health-related physiological endpoints or are not shown to have public health significance due to the prevalence of a clinically relevant nutrient deficiency. For infants 7 to 12 months, children 1 through 3 years of age, and pregnant and lactating women, we tentatively conclude that the essential vitamins and minerals, other than iron, calcium, vitamin D and potassium, do not have public health significance and there is no basis for the declaration of these nutrients to be different from that proposed for the general population. Accordingly, proposed § 101.9(c)(8)(ii) would allow the voluntary declaration of vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and PO 00000 Frm 00061 Fmt 4701 Sfmt 4702 11939 choline on foods represented or purported to be specifically for infants 7 to 12 months, children 1 through 3 years of age, or pregnant and lactating women, under the requirements of this section, unless they are added to foods as a nutrient supplement or if the label or labeling makes a claim about them, in which case the nutrients would have to be declared. 5. DRVs and RDIs for Infants 7 Through 12 Months of Age FDA regulations do not include DRVs or RDIs for nutrients for infants 7 through 12 months of age, except an RDI for protein of 14 g for infants. We reviewed scientific evidence and recommendations, as well as comments in response to the 2007 ANPRM to consider establishing DRVs and RDIs for nutrients for infants 7 through 12 months of age and to consider revisions to the current RDI for protein. a. Calories—We have not established a reference calorie intake level for infants and children less than 2 years of age. For the general population, a reference calorie intake level is necessary when using a percent of calories approach to calculating the DRV for nutrients, such as total fat and carbohydrate. There is no quantitative intake recommendation for calories for infants and we are not aware of other scientific data and information on which we could rely to establish that level. Therefore, we are not proposing to establish a reference calorie intake level for infants 7 to 12 months. b. Total Fat—The IOM set an AI of 30 g/d for fat for infants 7 through 12 months of age based on the average intake of human milk and complementary foods (Ref. 49). There was no AI available in 1993. The current AI provides a basis on which we can determine an appropriate DRV for total fat for this subpopulation that can assist consumers in maintaining healthy dietary practices among this subpopulation. Therefore, we are proposing to amend § 101.9(c)(9) to include a DRV of 30 g for fat for infants 7 through 12 months of age. c. Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber and Sugars— There are no quantitative intake recommendations from U.S. consensus reports available for saturated fat, trans fat, cholesterol, dietary fiber, and sugars for infants. We are not aware of other scientific data and information on which we could rely to establish DRVs for these nutrients for infants 7 through 12 months of age. Accordingly, we are not proposing to establish DRVs for these nutrients for infants 7 through 12 months of age. E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11940 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules d. Polyunsaturated Fat, Monounsaturated Fat, Insoluble Fiber, Soluble Fiber, Insoluble Fiber, Added Sugars, and Sugar Alcohols— Quantitative intake recommendations from U.S. consensus reports are not available for polyunsaturated fat, monounsaturated fat, insoluble fiber, soluble fiber, added sugars, or sugar alcohols for infants. We are not aware of other scientific data and information on which we could rely to establish DRVs for these nutrients for this subpopulation. Accordingly, we are not proposing to establish DRVs for these nutrients for infants 7 through 12 months of age. e. Total Carbohydrate—The IOM has set an AI of 95 g/d for carbohydrates for infants 7 through 12 months of age based on the average intake of human milk and complementary foods (Ref. 68). There was no AI available in 1993. The current AI provides a basis on which we can determine an appropriate DRV for total carbohydrate for this subpopulation that can assist consumers in maintaining healthy dietary practices among this subpopulation. Therefore, we are proposing to amend § 101.9(c)(9) to establish a DRV of 95 g for total carbohydrate for infants 7 through 12 months of age. f. Protein—The DV for protein for infants is an RDI, rather than a DRV. Before 1993, we established the RDIs for protein for all age groups based on the 1989 RDA. In 1993, we changed the RDI for protein for the general population to a DRV in response to comments that suggested the DV for protein should be consistent with the ‘‘percent of calories’’ approach used for the other energyyielding macronutrients, total fat and total carbohydrate (58 FR 2206 at 2216). However, we retained the RDI for infants, and based it on the highest 1968 RDA value (14 g/d for infants), to be consistent with a population-coverage approach (58 FR 2206 at 2216). We find no reason to change the approach of using the RDI for infants 7 through 12 months. However, we consider it appropriate to revise the RDI to rely on current quantitative intake recommendations. In 2002, the IOM established an RDA for infants 7 through 12 months of 1.2 g/kg/d based on nitrogen balance studies and using a reference body weight of 9 kg (Ref. 84). This reference body weight is also consistent with current growth charts for infants (Ref. 156). The value 1.2g/kg/ g×9 kg equals 10.8 g/d or a rounded value of 11 g/d. In addition, protein intakes are well above the current and proposed RDI. Mean protein intake for infants 6 to 11 months of age was 22 g/d (Ref. 150), well above the RDA of 11 VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 g/d. Accordingly, we are proposing to revise § 101.9(c)(9) to establish an RDI of 11 g for protein for infants 7 through 12 months of age. g. Sodium—For the general population, we are proposing to establish a DRV for sodium based on the IOM’s UL (section II.F.). The IOM did not set a UL for sodium for infants 7 through 12 months of age due to insufficient data on adverse effects of chronic overconsumption in this age group (Ref. 10). We are not aware of other scientific data and information on which we could rely to establish a DRV for sodium for this subpopulation. Therefore, we are not proposing a DRV for sodium for infants 7 through 12 months of age. h. Fluoride—As discussed in section II.G., although the IOM set an AI for fluoride, the AIs for infants 7 through 12 months and children 1 through 3 years are close to the EPA benchmarks for total fluoride intake (Ref. 92). We are not proposing a DRV for fluoride for use in the labeling of foods for the general population because of a concern about excess intakes associated with dental fluorosis (section II.G.). Therefore, we tentatively conclude that a DRV for fluoride is not warranted for infants 7 through 12 months. The use of such a DRV to calculate percent DV may have the unintended effect of consumers selecting foods with higher fluoride amounts, which are not necessary or advised. Accordingly, we are not proposing to establish a DRV for fluoride for infants 7 through 12 months of age. i. Vitamins and Minerals—As noted previously in the introduction to section II.K., while not included in current regulations, the preamble to the 1993 DRV/RDI final rule provides a table listing RDIs for infants (58 FR 2206 at 2213), which is also provided in FDA’s Food Labeling Guide (Ref. 144). We reviewed current quantitative intake recommendations for vitamins and minerals for infants and considered comments received in response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for vitamins and minerals to be established in regulations for infants 7 through 12 months of age. We consider it important to establish RDIs for infants 7 through 12 months of age because infants in this age range transition from a diet of mostly breast milk and infant formula to infant cereal and baby foods (Ref. 147 p. 71) and labeling foods for this subpopulation with percent DV declarations can assist parents in making nutritious food choices. The DRIs (AIs and RDAs) provide a basis on which to determine RDIs for vitamins and minerals for this PO 00000 Frm 00062 Fmt 4701 Sfmt 4702 subpopulation. We consider it appropriate to use RDAs and, in the absence of RDAs, AIs to determine appropriate micronutrient RDIs for infants. While there is more certainty with RDAs than AIs, both RDAs and AIs are sufficient for setting RDIs, because they both represent intake levels that are expected to meet or exceed the nutrient needs of the majority of infants (Ref. 157). We also considered and rejected an approach, as suggested by a comment, where the highest reference value available would be used for each nutrient, irrespective of whether it is an RDI based on the 1968 RDAs, a current RDA, or a current AI. The IOM established DRIs based on scientific knowledge that update and supersede previous RDA recommendations. Because DRIs are available for infants 7 through 12 months of age, we are proposing to use these current quantitative intake recommendations (i.e., AIs and RDAs) for setting RDIs for infants. Accordingly, we are proposing to amend § 101.9(c)(8)(iv) to include a listing of RDIs for vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, vitamin B12, folate, choline, riboflavin, niacin, vitamin B6, calcium, iron, thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and potassium for infants 7 months through 12 months of age. We invite comment on the adequacy of the proposed RDIs for vitamins and minerals for older infants. 6. DRVs and RDIs for Children 1 Through 3 Years of Age FDA regulations do not include DRVs or RDIs for nutrients for children 1 through 3 years of age, except an RDI for protein of 16 g for children less than 4 years of age. We reviewed scientific evidence and current recommendations, as well as comments in response to the 2007 ANPRM to consider establishing DRVs and RDIs for nutrients for this subpopulation and to consider revisions to the current RDI for protein. a. Calories—We have not established a reference calorie intake level for nutrition labeling for children ages 1 through 3 years. Several comments to the 2007 ANPRM supported establishing a DV for calories specifically for young children 1 through 3 years of age. Citing the IOM and AAP/AHA caloric intake recommendations (Refs. 50 and 71), one comment recommended 1,050 calories as the DV for calories and supported E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules rounding it down to 1,000 calories to facilitate use by consumers. We consider it appropriate to establish a reference calorie intake level for children 1 through 3 years of age because, as discussed in this document, we are proposing to set DRVs using quantitative intake recommendations that are based on calories (e.g., total fat, saturated fat, and dietary fiber). Current recommendations from the IOM, AHA, AAP, and the 2010 DGA for caloric intake range from 800 to 900 calories/d for children 1 year old, approximately 1,000 calories/d for children 2 years of age, and from 1,000 to 1,200 calories/d for children 3 years of age (Refs. 6, 50, and 71) . We consider that an average of the range of these caloric intake recommendations (800 to 1,200 calories/ d), i.e., 1,000 calories/d, provides a reasonable reference calorie intake level. Therefore, we are proposing to amend § 101.9(c)(9) to provide a reference calorie intake level of 1,000 calories/d for children 1 through 3 years of age. b. Total Fat—There is no DRV for total fat for children ages 1 through 3 years. One comment to the 2007 ANPRM recommended that 35 percent of the recommended 1,050 calories or 41 g/d of fat be used to as the DRV for fat because it is the midpoint of the AAP/ AHA recommendation and the IOM Acceptable Macronutrient Distribution Range (AMDR) for 1 through 3 year olds. We agree that 35 percent of calories from fat for children 1 through 3 years of age, the midpoint of the IOM AMDR of 30 to 40 percent, serves as an appropriate basis on which to set the DRV for total fat. This approach to calculating the DRV for total fat is consistent with our proposed approach to setting the DRV for total fat for the general population. Thirty-five percent is also consistent with AHA and AAP recommendations that 30 to 40 percent of calories consumed by children 12 through 24 months of age and 30 to 35 percent of calories consumed by children 24 through 48 months of age should come from fat (Ref. 71). Therefore, we tentatively conclude that 35 percent of total calories from fat (i.e., 39 g using the proposed reference calorie intake level of 1,000 calories/d) is an appropriate DRV for total fat for children 1 through 3 years of age. Accordingly, we are proposing to amend § 101.9(c)(9) to establish a DRV of 39 g for fat for children 1 through 3 years of age. c. Saturated Fat, Trans Fat, and Cholesterol—There are no DRVs for saturated fat, trans fat, or cholesterol for children 1 through 3 years of age. Once comment to the 2007 ANPRM suggested using the midpoint of 10 to 15 percent VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 of calories for saturated fat, 2 percent of calories for trans fat based on estimates of mean trans fat intake for the U.S. population 3 years of age and older, and less than or equal to 300 mg/d for cholesterol based on the 2005 DGA recommendation. Cardiovascular disease is known to begin in childhood (Refs. 146 and 151). The 2010 DGA recommends that Americans 2 years of age and older consume less than 10 percent of calories from saturated fat and less than 300 mg/ d of cholesterol (Ref. 6). Based on these recommendations, we tentatively conclude that it is appropriate to set a DRV of 10 g for saturated fat, based on 10 percent of total calories from saturated fat and using the proposed reference calorie intake level of 1,000 calories/d which equals 11 g, rounded down to 10 g, and a DRV of 300 mg for cholesterol for children 1 through 3 years of age. The comment provided no rationale for using an upper range of 15 percent of calories from saturated fat. We have no information to indicate that applying the level of 10 percent of calories from saturated fat to this subpopulation is restrictive, as the comment asserted. Accordingly, we are proposing to amend § 101.9(c)(9) to establish a DRV of 10 g for saturated fat and a DRV of 300 mg for cholesterol for children 1 through 3 years of age. Current recommendations from the IOM (Ref. 49) and 2010 DGA (Ref. 6) recommend keeping trans fat intake as low as possible but do not provide any specific appropriate levels of intake. Thus, consistent with our discussion in section II.B.3., we disagree with the comment that suggested setting a DRV for trans fat and, therefore, we are not proposing to establish a DRV for trans fat in response to this comment. d. Polyunsaturated Fat, Monounsaturated Fat, Sugars, Added Sugars, Insoluble Fiber, Soluble Fiber, and Sugar Alcohols—There are no DRVs for polyunsaturated fat, monounsaturated fat, sugars, added sugars, insoluble fiber, soluble fiber, or sugar alcohol for children 1 through 3 years of age. One comment to the 2007 ANPRM recommended establishing a DV for n-3 polyunsaturated fatty acids (a-linolenic acid) of 700 mg/d because a- linolenic acid is essential to the human diet and children 1 through 3 years of age are below recommended intake levels. We disagree that a DRV should be set for n-3 polyunsaturated fatty acids for children 1 through 3 years of age for the same reasons that we are not proposing a DRV for these fatty acids for the general population (see section II.B.). We recognize the essential nature of a-linolenic acid in the diet. PO 00000 Frm 00063 Fmt 4701 Sfmt 4702 11941 The IOM based AIs for n-6 linoleic and n-3 a-linolenic acid on U.S. median intake levels because of the lack of linoleic and a- linolenic acid deficiency in non-institutionalized populations in the United States (Ref. 49). For children 1 through 3 years of age, DRIs or other data and information are not available on which we could rely to establish DRVs for polyunsaturated fat, monounsaturated fat, sugars, added sugars, insoluble fiber, soluble fiber, and sugar alcohols. Therefore, we tentatively conclude that there is no basis for setting DRVs for these nutrients. Accordingly, we are not proposing DRVs for polyunsaturated fat, including n-3 or n-6 polyunsaturated fatty acids, monounsaturated fat, sugars, added sugars, soluble fiber, insoluble fiber, or sugar alcohols for children 1 through 3 years of age. e. Total Carbohydrate—There is not a DRV for total carbohydrate for children 1 through 3 years of age. One comment to the 2007 ANPRM suggested that we establish a DV for carbohydrates using 59 percent of calories from carbohydrates, or 154 g using the method of calculation by difference. As discussed in section II.D.1., we are proposing a DRV for total carbohydrate for the general population based on the percentage of calories in a 2,000 calorie diet remaining after the sum of the DRV for fat (30 percent) plus the DRV for protein (10 percent) have been subtracted. We also consider this method to be appropriate for setting a DRV for total carbohydrate for children 1 through 3 years of age. Total calories (100 percent) minus the proposed DRV for total fat (35 percent of calories) and the proposed DRV for protein (5 percent of calories) equals 60 percent of calories from total carbohydrate. A value of 60 percent of total calories from total carbohydrates also falls within the IOM AMDR recommendation of 45 to 65 percent of calories from carbohydrates for children 1 through 3 years of age. Therefore, we tentatively conclude that an appropriate DRV for total carbohydrate is 60 percent of calories (i.e., 150 g using the proposed reference calorie intake level of 1,000 calories/d). Accordingly, we are proposing to amend § 101.9(c)(9) to set a DRV of 150 g for total carbohydrate for children 1 through 3 years of age. f. Dietary Fiber—There is not a DRV for dietary fiber for children 1 through 3 years of age. One comment to the 2007 ANPRM recommended using 15 g/d as the basis of the DRV for dietary fiber, based on the AI of 14 g/1,000 calories and a 1,050 calorie diet. We agree that the AI of 14 g/1,000 calories for dietary fiber for children 1 through 3 years of E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11942 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules age (Ref. 66) should be used to set a DRV for dietary fiber to be consistent with how other proposed DRVs are being set. Given that we are proposing a reference calorie intake level of 1,000 calories/d for this subpopulation, we are proposing to amend § 101.9(c)(9) to establish a DRV of 14 g for dietary fiber for children 1 through 3 years of age. g. Protein—The RDI for protein for children less than 4 years of age was based on the 1989 RDA for protein of 16 g/d (§ 101.9(c)(7)(iii)). One comment to the 2007 ANPRM recommended maintaining the DV of 16 g for protein because the RDA for protein of 13 g/d for toddlers 1 through 3 years of age appears low relative to the amount of protein from a diet pattern consistent with dietary guidance from AAP/AHA. We consider it appropriate to determine whether changes are necessary to the current RDI taking into account current recommendations and protein intakes. Protein intakes are well above the current RDI. Mean protein intake for children 12 to 23 months of age was 44 g/d (Ref. 150), well above the RDA of 13 g/d and the midpoint of the AMDR of 5 to 20 percent calories from protein (i.e., 12.5 percent of calories from protein or 31 g/d) (Ref. 84). The protein AMDR for children 1 through 3 years of age is 5 to 20 percent of calories and the RDA is approximately 5 percent of calories (Ref. 84). While the RDA is lower than the amount of protein consistent with guidance from AAP/ AHA, we explain in section II.B.2.c. that we do not consider the menu modeling approach used to develop this guidance appropriate to determine DRVs because it does not permit the selection of DRVs that are based on scientific evidence related to actual public health outcomes. In light of the proposed reference calorie intake level and the approaches used for the proposed DRVs for fat and carbohydrate that are based on percent of calories, we tentatively conclude that, as with the general population, the DV for protein for children 1 through 3 years of age should be a DRV, rather than an RDI (using the RDA). Therefore, we tentatively conclude that a DRV for protein should be based on 5 percent of 1,000 calories or 50 calories which equals 12.5 g or, when rounded up, is 13 g. Accordingly, we are proposing to amend § 101.9(c)(7)(iii) to establish a DRV for protein of 13 g for children 1 through 3 years of age. h. Sodium—For the general population, we are proposing to establish a DRV based on the UL for sodium (section II.F.). There is no DRV for sodium for children 1 through 3 years of age. Two comments to the 2007 VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 ANPRM recommended basing the DRV for sodium on the IOM’s UL of 1,500 mg/d for children 1 through 3 years of age to be consistent with recommendations from AAP and AHA (Ref. 71). The IOM derived the UL for children 1 through 3 years of age by extrapolation from the adult UL of 2,300 mg/d based on observational studies showing that blood pressure increases with age into adulthood and the recognition that risk factors for CVD, such as high blood pressure and atherosclerosis, occur in childhood (Ref. 10). We agree with the comments noting that 1,500 mg is an appropriate DRV for sodium for children 1 through 3 years of age. Consistent with the proposed approach for the general population, we are proposing to amend § 101.9(c)(8)(iv) to establish a DRV of 1,500 mg for sodium for children 1 through 3 years of age. i. Fluoride—There is not a DV for fluoride for children 1 through 3 years of age. One comment to the 2007 ANPRM suggested that fluoride should not have a DV because it is not found abundantly in food. We disagree with this comment. Whether a nutrient is found abundantly in food is not a consideration for FDA in setting DVs. The IOM recognized fluoride as a trace mineral that is important for public health by setting an AI based on evidence of its role in reducing the risk of dental caries. However, we tentatively conclude that a DRV should not be established for fluoride. Although the IOM set an AI for fluoride, the AI for children 1 through 3 years of age is close to the EPA benchmarks for maximum total fluoride intake (Ref. 92). In addition, we are not proposing a DRV for the general population because of concern about excess intakes associated with dental fluorosis (see section II.G.). The use of such a DRV to calculate percent DV may have the untoward effect of consumers selecting foods with higher fluoride amounts, which are not necessary or advised. Therefore, we tentatively conclude that a DRV for fluoride is not warranted for children 1 through 3 years of age. Accordingly, we are not proposing a DRV for fluoride for children 1 through 3 years of age. j. Vitamins and Minerals—As explained earlier, while not included in our regulations, the preamble to the 1993 DRV/RDI final rule provides a table listing RDIs for children less than 4 years of age (58 FR 2206 at 2213), which is also provided in FDA’s Food Labeling Guide (Ref. 144). We reviewed current quantitative intake recommendations for vitamins and minerals for infants and considered PO 00000 Frm 00064 Fmt 4701 Sfmt 4702 comments received in response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for vitamins and minerals for children 1 through 3 years of age. The IOM’s quantitative intake recommendations (AIs and RDAs) provide a basis on which to determine RDIs for vitamins and minerals for this subpopulation. In addition, where data on functional indicators of nutritional status were available, the IOM relied on such data and determined that available evidence was sufficient to establish appropriate RDAs and AIs for vitamins and minerals for this subpopulation. Therefore, we disagree with a comment to the 2007 ANPRM that suggested that more population-specific data based on functional indicators of nutritional status are needed before establishing the RDIs for vitamins and minerals. We consider it appropriate to use RDAs and, in the absence of RDAs, AIs to determine appropriate micronutrient RDIs for children 1 through 3 years of age. As such, we agree with comments that suggested using RDAs to determine the RDIs for selenium and vitamin E and AIs to determine the RDIs for choline, vitamin K, and manganese, which do not have established RDAs. The RDA, when available, is the best estimate of an intake level that will meet the nutrient goals of practically all consumers who would use the Nutrition Facts label. AIs have less certainty than RDAs, but they represent goals for nutrient intake for individuals and provide the best estimate based on current science for use in setting RDIs for such nutrients. Finally, we disagree with comments suggesting we use 1,800 or 2,000 mg/d potassium as the basis for the RDI for potassium because it is inconsistent with the proposed approach for the general population. The comments did not explain why data collection on mean potassium intake should be the basis for the DV in lieu of the AIs and RDAs. In addition, promoting the development of eating patterns that will be associated with adequate potassium intake later in life is important because chronic conditions such as elevated blood pressure, bone demineralization, and kidney stones likely result from inadequate potassium intakes over an extended period of time, including childhood (Ref. 136). The AI for potassium is 3,000 mg/d and we consider it an appropriate basis for establishing a RDI for potassium for children 1 through 3 years of age. Therefore, using the RDAs and AIs, we are proposing to amend § 101.9(c)(8)(iv) to establish RDIs as set forth previously for vitamin A, vitamin E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules C, vitamin D, vitamin E, vitamin K, vitamin B12, folate, choline, riboflavin, niacin, vitamin B6, calcium, iron, thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and potassium for children 1 through 3 years of age. We invite comment on the adequacy of the proposed RDIs for vitamins and minerals for children 1 through 3 years of age. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 7. DRVs and RDIs for Pregnant and Lactating Women a. Calories—The reference calorie intake of 2,000 used for the general population applies to pregnant and lactating women (§ 101.9(c)(9)). The calorie needs for pregnant and lactating women are similar to the general population and few products are purported for pregnant and lactating women. Therefore, we tentatively conclude that it is appropriate to establish a reference calorie intake level for setting DRVs for pregnant and lactating women that is the same as for the general population. Accordingly, we are proposing to use the 2,000 reference calorie intake level for setting DRVs for pregnant and lactating women (§ 101.9(c)(9)). b. Total Fat, Saturated Fat, Cholesterol, Total Carbohydrate, Sodium, and Dietary Fiber—FDA regulations do not provide DRVs for total fat, saturated fat, cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant and lactating women. Quantitative intake recommendations for total fat, saturated fat, cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant and lactating women are generally similar to the general population (Refs. 6 and 23). Therefore, we tentatively conclude that the DRVs for total fat, saturated fat, cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant and lactating women should remain the same as for the general population. Accordingly, we are proposing to amend § 101.9(c)(9) to establish DRVs for pregnant and lactating women using the proposed DRVs for the general population for total fat, saturated fat, cholesterol, total carbohydrate, sodium, and dietary fiber. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 c. Trans Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble Fiber, Insoluble Fiber, Sugars, Added Sugars, and Sugar Alcohols—There are no DRVs for trans fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugars, added sugars, or sugar alcohol for pregnant and lactating women. As discussed in sections II.B. and II.D., we are not proposing DRVs for these nutrients for the general population because of a lack of quantitative intake recommendations. Similarly, quantitative intake recommendations are lacking for these nutrients for pregnant and lactating women. Therefore, we are not proposing to establish DRVs for trans fat, polyunsaturated and monounsaturated fat, soluble fiber, insoluble fiber, sugars, added sugars, or sugar alcohols for pregnant and lactating women. d. Protein—FDA established RDIs of 60 g protein for pregnant women and 65 g protein for lactating women (§ 101.9(c)(7)(iii)) based on the highest 1989 RDAs for pregnant and lactating women (58 FR 2206 at 2216). The IOM established 71 g/d protein as the RDA for pregnant and lactating women based on the needs for maternal and fetal development and human milk production. Because the RDA for protein during both pregnancy and lactation is the same (Ref. 84) and given that most foods represented or purported to be specifically for pregnant women are also represented or purported to be specifically for lactating women, we tentatively conclude that it is appropriate to establish a single RDI of 71 g applicable to both pregnant and lactating women. We tentatively conclude that the DV for protein for pregnant and lactating women should remain an RDI (using the RDA) instead of a DRV because the DRV approach used to calculate protein for the general population based on 10 percent of 2,000 calories, which equals 50 g of protein/ d, falls short of the recommended protein needs of pregnant and lactating women of 71 g/d. Therefore, we are proposing to amend § 101.9(c)(7)(iii) to establish an RDI of 71 g for protein for pregnant and lactating women. e. Fluoride—There is no DRV for fluoride for the general population or for pregnant and lactating women. While an PO 00000 Frm 00065 Fmt 4701 Sfmt 4702 11943 AI has been established for fluoride, we are not proposing to establish a DRV for fluoride for the general population for the reasons discussed in section II.G. Similarly, because the AI for fluoride for pregnant and lactating women is not different from the general population (Ref. 90), we are not proposing a DRV for fluoride for pregnant and lactating women. f. Vitamins and Minerals—While not included in FDA regulations, the preamble to the 1993 DRV/RDI final rule provides a table listing RDIs for pregnant and lactating women (58 FR 2206 at 2213), which is also provided in FDA’s food labeling guide (Ref. 144). We reviewed current quantitative intake recommendations for vitamins and minerals for pregnant and lactating women and considered comments received in response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for vitamins and minerals for pregnant and lactating women. For the same reasons stated for the general population (see section II.I.), we consider it appropriate to establish RDIs for pregnant and lactating women for vitamins and minerals that have DRIs, using population-coverage RDAs and AIs, instead of population-weighted EARs. In addition, we are proposing to establish a single set of RDIs intended for both pregnant women and lactating women because nutrient needs during pregnancy and lactation are similar (Refs. 16, 17, 21, 22, 140). Moreover, most foods represented or purported to be specifically for pregnant women are, at the same time, represented or purported to be specifically for lactating women and, as such, using one set of RDIs would address practical concerns related to limited space on food labels. Therefore, we are proposing to amend § 101.9(c)(8)(iv) to establish RDIs as set forth previously for vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, vitamin B12, folate, choline, riboflavin, niacin, vitamin B6, calcium, iron, thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and potassium for pregnant and lactating women. E:\FR\FM\03MRP2.SGM 03MRP2 11944 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules TABLE 3—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND FROM TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENTS) OF U.S. INFANTS 7 THROUGH 12 MONTHS OF AGE 1 Usual nutrient intake 2 % Below the EAR 4 EAR 3 Nutrients Food Iron ........................................................................................................................ Zinc ....................................................................................................................... 6.9 mg ...................................... 2.5 mg ...................................... Total intake 17.8 0.1 3.7 0.1 AI 3 ............................................ Choline .................................................................................................................. Folate .................................................................................................................... Niacin .................................................................................................................... Riboflavin .............................................................................................................. Thiamin ................................................................................................................. Vitamin A ............................................................................................................... Vitamin B6 ............................................................................................................. Vitamin B12 ............................................................................................................ Vitamin C ............................................................................................................... Vitamin D ............................................................................................................... Vitamin E ............................................................................................................... Vitamin K ............................................................................................................... Calcium ................................................................................................................. Copper .................................................................................................................. Magnesium ............................................................................................................ Phosphorus ........................................................................................................... Potassium ............................................................................................................. Selenium 6 ............................................................................................................. % Above AI 5 150 mg ..................................... 80 mcg ..................................... 4 mg ......................................... 0.4 mg ...................................... 0.3 mg ...................................... 500 mcg ................................... 0.3 mg ...................................... 0.5 mg ...................................... 50 mg ....................................... 10 mcg ..................................... 5 mcg ....................................... 2.5 mcg .................................... 260 mg ..................................... 220 mcg ................................... 75 mg ....................................... 275 mg ..................................... 700 mg ..................................... 20 mcg ..................................... 23.5 100 99.9 100 99.9 86.9 99.9 99.8 90.1 28.7 67 100 99.6 100 97.6 98.9 98.8 9.9 23.5 100 99.9 100 99.9 87.5 99.9 99.8 94 33.6 70.6 100 99.6 100 97.6 98.9 98.8 9.9 1 All prevalence of nutrient inadequacy or adequacy and status biomarker data is based on NHANES 2003–2006 except for vitamin D and choline (NHANES 05–08). 2 Usual nutrient intake distributions from conventional foods are determined using the National Cancer Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48). 3 The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for infants ages 7–12 months are established by the Institute of Medicine https://www.iom.edu/Activities/Nutrition/SummaryDRIs/∼/media/Files/Activity%20Files/Nutrition/DRIs/New%20Material/2_ %20RDA%20and%20AI%20Values_Vitamin%20and%20Elements.pdf. 4 The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy for iron and zinc. For iron, refer to Table I–5 Probability of inadequate iron intakes (Refs. 100 and 158). 5 For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at or above the AI. 6 We did not receive any comments for this nutrient (for which voluntary declaration is permitted) in response to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database for chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these nutrients are not listed in this table. TABLE 4—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS OF THE U.S. POPULATION OF CHILDREN 1 THROUGH 3 YEARS OF AGE 1 Usual nutrient intake 2 % below EAR 4 Nutrient EAR 3 Status biomarker Total intake Food Biomarker cutoff mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Folate ................................ 120 mcg .................. 0.1 0.1 Serum folate < 2 ng/mL RBC folate < 95 ng/mL ..... Niacin ................................ Riboflavin .......................... Thiamin ............................. Vitamin A .......................... Vitamin B6 ......................... Vitamin B12 ........................ Vitamin C .......................... Vitamin D .......................... 5 mg ........................ 0.4 mg ..................... 0.4 mg ..................... 210 mcg .................. 0.4 mg ..................... 0.7 mcg ................... 13 mg ...................... 10 mcg .................... 0.6 0 0 1.9 1.5 0 1.9 82.0 0.6 0 0 1.5 1.1 0 1.3 66.5 N/A ............................................................................ N/A ............................................................................ N/A ............................................................................ N/A ............................................................................ Serum B6 (pyridoxal 5′ phosphate) < 20 nmol/L ...... Serum B12 < 200 pg/mL ........................................... N/A ............................................................................ Serum 25(OH)D ........................................................ Vitamin E .......................... Calcium ............................. Copper .............................. Iron .................................... VerDate Mar<15>2010 5 mg ........................ 500 mg .................... 260 mcg .................. 3 mg ........................ 19:06 Feb 28, 2014 Jkt 232001 PO 00000 84.6 11.7 0.2 1.0 Frm 00066 61.6 11.7 0.2 0.42 Fmt 4701 < 50 nmol/L ............................................................... < 40 nmol/L ............................................................... < 30 nmol/L ............................................................... Serum E < 516 mcg/dL ............................................ N/A ............................................................................ N/A ............................................................................ Serum ferritin < 12 mcg/L (99–02) 5 ......................... Iron deficiency (Ferritin model, 99–02) ..................... Sfmt 4702 E:\FR\FM\03MRP2.SGM 03MRP2 % Below cutoff 0.01 0.17 N/A N/A N/A N/A 2.57 0.2 N/A 8.2 2.9 0.8 1.3 N/A N/A 17.7 7.9 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 11945 TABLE 4—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS OF THE U.S. POPULATION OF CHILDREN 1 THROUGH 3 YEARS OF AGE 1—Continued Usual nutrient intake 2 % below EAR 4 Nutrient EAR 3 Total intake Food Magnesium ....................... Phosphorus ....................... Selenium 6 ......................... Zinc ................................... 65 mg ...................... 380 mg .................... 17 mcg .................... 2.5 mg ..................... AI 3 .......................... Choline .............................. Potassium ......................... Vitamin K .......................... 200 mg .................... 3000 mg .................. 30 mcg .................... Status biomarker Biomarker cutoff % Below cutoff 0 0.2 0 1.2 1.8 23.3 9.5 N/A N/A N/A N/A 48.5 6.5 51.2 0 0.2 0 1.4 Anemia (99–02) ........................................................ Serum ferritin < 12 mcg/L (03–06) ........................... Iron deficiency (Body iron model, 03–06) ................. N/A ............................................................................ N/A ............................................................................ N/A ............................................................................ N/A ............................................................................ N/A ............................................................................ N/A ............................................................................ N/A ............................................................................ N/A N/A N/A % Above AI 7 46.4 6.5 50.9 N/A = Data is not available in NHANES; mg = milligrams; mcg = micrograms. 1 All prevalence of nutrient adequacy or inadequacy and status biomarker data is based on NHANES 2003–2006 except for vitamin D and choline intakes (2005–2008); serum pyridoxal-5′-phosphate (2005–2006); serum tocopherol for age 3 years (1999–2002), and serum ferritin (1999–2002). 2 Usual nutrient intake distributions from conventional foods are determined using the National Cancer Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48). 3 The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for children 1–3 years of age are established by the Institute of Medicine. Units are in mg/d or mcg/d https://www.iom.edu/Activities/Nutrition/SummaryDRIs/∼/media/Files/Activity%20Files/Nutrition/DRIs/ New%20Material/2_%20RDA%20and%20AI%20Values_Vitamin%20and%20Elements.pdf. 4 The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy. For iron, refer to Table I–5 Probability of inadequate iron intakes (Ref. 100). 5 Serum ferritin analysis changed from the Biorad assay to the Roche assay in 2003. Serum ferritin for 2003–2006 using the Biorad assay was adjusted to be comparable to those 2004–2006 data using the Roche assay. Iron deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables (transferrin saturation, serum ferritin, and erythrocyte protoporphyrin, NHANES 1999–2002) (Refs. 155 and 159). Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to ferritin using NHANES 2003–2006 data. NHANES 1999–2002 did not measure transferrin receptor; therefore body iron model could not be analyzed for this time frame. NHANES 2003–2006 did not measure all iron biomarkers for all ages, thus serum ferritin, body iron model or ferritin model could not be analyzed for all ages during this time period. 6 We did not receive any comments for this nutrient (for which voluntary declaration is permitted) in response to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database for chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these nutrients are not listed in this table. 7 For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at or above the AI. TABLE 5—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS OF THE U.S. POPULATION OF PREGNANT WOMEN 14–50 YEARS OF AGE 1 Usual nutrient intake 2 Weighted EAR 3 Nutrient % below EAR 4 Food Status biomarker Total intake mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Folate ................................. 520 mcg ................... 39.6 27.5 Niacin ................................. Riboflavin ........................... Thiamin .............................. Vitamin A ........................... Vitamin B6 .......................... Vitamin B12 ......................... Vitamin C ........................... Vitamin D ........................... 14 mg ....................... 1.2 mg ...................... 1.2 mg ...................... 549 mcg ................... 1.6 mg ...................... 2.2 mcg .................... 70 mg ....................... 10 mcg ..................... 3.7 3.6 10.4 36.4 28.3 1.6 21.7 87.6 2.6 3.1 6.1 22 15.7 1.1 11.2 47.6 Vitamin E ........................... Calcium .............................. Copper ............................... Iron ..................................... VerDate Mar<15>2010 12 mg ....................... 835 mg ..................... 0.79 mcg .................. 22 mg ....................... 19:06 Feb 28, 2014 Jkt 232001 PO 00000 94.8 20.7 4.4 5.3 Frm 00067 51 18.9 4.1 3.71 Fmt 4701 Biomarker cutoff Serum folate < 2 ng/mL ............................................... RBC folate < 95 ng/mL ................................................ N/A ................................................................................ N/A ................................................................................ N/A ................................................................................ Serum A < 20 mcg/mL ................................................. Serum B6 (Pyridoxal 5’ phosphate) < 20 nmol/L ......... Serum B12 < 200 pg/mL ............................................... Serum C < 11.4 μmol/L ................................................ Serum 25(OH)D < 50 nmol/L .................................................................. < 40 nmol/L .................................................................. < 30 nmol/L .................................................................. Serum E < 516 mcg/dL ................................................ N/A ................................................................................ N/A ................................................................................ Serum ferritin < 15 mcg/L ............................................ 5 Iron deficiency —Body iron model ................................................. —Ferritin model Anemia ....................................... Sfmt 4702 E:\FR\FM\03MRP2.SGM 03MRP2 % below cutoff 0.28 0 N/A N/A N/A 1.0 0 4.1 0.4 16.9 6.4 3.7 0.6 N/A N/A 26.1 16.4 25.1 11946 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules TABLE 5—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS OF THE U.S. POPULATION OF PREGNANT WOMEN 14–50 YEARS OF AGE 1—Continued Usual nutrient intake 2 % below EAR 4 Weighted EAR 3 Nutrient Food Magnesium ........................ Phosphorus ........................ Selenium 6 .......................... Zinc .................................... 295 mg ..................... 583 mg ..................... 49 mcg ..................... 9.5 mg ...................... Weighted AI 3 Choline ............................... Potassium .......................... Vitamin K 6 ......................... Status biomarker Total intake Biomarker cutoff % below cutoff 55.0 0.3 0.7 12.8 N/A N/A N/A N/A ................................................................................ ................................................................................ ................................................................................ ................................................................................ 12.8 N/A N/A N/A N/A 13.6 3.9 36.1 57.2 0.3 0.7 15.9 N/A ................................................................................ N/A ................................................................................ N/A ................................................................................ N/A N/A N/A % Above AI 7 450 mg ..................... 4700 mg ................... 89 mcg ..................... 13.5 3.9 34.5 N/A = Data is not available in NHANES; mg = milligrams; mcg = micrograms. 1 All prevalence of nutrient adequacy or inadequacy and biomarker data is based on NHANES 2003–2006 except for vitamin D and choline intakes (2005–2008); serum pyridoxal-5’-phosphate (2005–2006); serum tocopherol (1999–2002), and serum ferritin (1999–2002). Biomarker data are for pregnant women 12 through 49 years of age. 2 Usual nutrient intake distributions from conventional foods are determined using the National Cancer Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48). 3 The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for pregnant women 14–50 years of age are established by the Institute of Medicine. Units are in mg/d or mcg/d https://www.iom.edu/Activities/Nutrition/SummaryDRIs/∼/media/Files/Activity%20Files/Nutrition/ DRIs/New%20Material/2_%20RDA%20and%20AI%20Values_Vitamin%20and%20Elements.pdf. 4 The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy. For iron, refer to Table I–5 Probability of inadequate iron intakes (Ref. 100). 5 Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to ferritin using NHANES 2003–2006 data. Iron deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables (transferrin saturation, serum ferritin, and erythrocyte protoporphyrin, NHANES 1999–2002) (Refs. 155 and 159). Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. 6 We did not receive any comments for these nutrients (for which voluntary declaration is permitted) in response to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database for chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these nutrients are not listed in this table. 7 For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at or above the AI. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 L. Dietary Supplements FDA regulations specific to dietary supplement nutrition labeling appear in § 101.36. Many requirements in § 101.36 are consistent with the requirements for the nutrition labeling of conventional foods in § 101.9 and there are references throughout § 101.36 to requirements established in § 101.9. As discussed previously, we are proposing several amendments to § 101.9 that, if finalized, would result in significant changes to the content and format of the Nutrition Facts label. For consistency, we are proposing to amend § 101.36 so that the content and format of the Supplement Facts label corresponds with that of the Nutrition Facts label. The IOM Labeling Report included a recommendation that the Supplement Facts label should use the same DVs as the Nutrition Facts label. In light of the IOM recommendation, we requested comment in the 2007 ANPRM on whether the Supplement Facts label should use the same DVs as the Nutrition Facts label, as suggested in the IOM labeling report. We received no comments in response to this question. We also did not receive any other VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 comments to the 2007 ANPRM that are relevant to the Supplement Facts label. We expect that the proposed DVs for infants 6 through 12 months, children 1 through 3 years, pregnant and lactating women, and individuals 4 years of age and older may result in reformulation of dietary supplement products. Reformulations could impact intakes of vitamins and minerals for all age groups. We invite comment, including the submission of data and other factual information, on the reformulation of dietary supplement products that may result from proposed changes to the DVs, as well as information on the potential consequences of such reformulations. Our proposed changes to the Supplement Facts label in light of proposed changes to the Nutrition Facts label are described in this document. 1. Mandatory Dietary Ingredients In § 101.36(b)(2), we established a list of dietary ingredients that have an RDI or a DRV as established in § 101.9(c)(8)(ii) that are referred to as the ‘‘(b)(2)-dietary ingredients.’’ These 15 nutrients must be listed in the Supplements Facts label for a dietary PO 00000 Frm 00068 Fmt 4701 Sfmt 4702 supplement when they are present in amounts that exceed the amount that can be declared as zero in the nutrition labeling of foods in accordance with § 101.9(c). Section § 101.9(c)(8)(ii) requires vitamin A, vitamin C, calcium, and iron to be declared on food labels. As discussed in section II.H., we are proposing to amend § 101.9(c)(8)(ii) to allow for voluntary declaration of vitamins A and C and to require mandatory declaration of calcium, vitamin D, potassium, and iron. In addition, we are proposing to eliminate the mandatory declaration of ‘‘Calories from fat’’ on the Nutrition Facts label (see section II.A.1.). We are proposing to update the list of (b)(2)-dietary ingredients to maintain consistency with the proposed requirements for nutrition labeling of foods in § 101.9. Therefore, proposed § 101.36(b)(2)(i) would: (1) No longer require declaration of vitamin A, vitamin C, or Calories from fat; (2) require vitamin D and potassium; (3) require the declaration of added sugars; and (4) retain the other (b)(2)-dietary ingredients as mandatory declarations. We are also proposing to amend E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules § 101.36(b)(2)(i), (b)(2)(i)(B)(1), and (b)(2)(iii)(G) to remove the requirement for declaration of ‘‘Calories from fat.’’ mstockstill on DSK4VPTVN1PROD with PROPOSALS2 2. Folate and Folic Acid We are proposing to only allow the use of the term ‘‘folic acid’’ for the labeling of dietary supplements. Folate is a nutrient found in conventional foods, whereas folic acid is the synthetic form of folate that is added to fortified conventional foods and dietary supplements. As discussed in section II.J.2., ‘‘folic acid’’ or ‘‘folacin’’ are identified as synonyms of folate and can be used on the Nutrition Facts label (§ 101.9(c)(8)(v)) or in the Supplement Facts label (§ 101.36(b)(2)(i)(B)(2)). However, because of the difference in bioavailability between naturally occurring folate, and synthetic folic acid, we are proposing to amend § 101.9(c)(8)(v) such that the term ‘‘folate’’ would be used in the labeling of conventional foods that contain either folate alone or a mixture of folate and folic acid. As discussed in section II.J.2.c., we consider only the term ‘‘folic acid’’ to be appropriate for use in the labeling of dietary supplements. Therefore, we are proposing to amend §§ 101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to specify that ‘‘folic acid’’ is the term used to declare folic acid content of dietary supplements; and to remove ‘‘folate’’ and ‘‘folacin’’ from the list of synonyms that may be used to declare folic acid on the Supplement Facts label. 3. Units of Measure In section II.J.3., we are proposing to amend § 101.9(c)(8)(iv) to replace ‘‘IU’’ for the RDIs for vitamin A, vitamin D, and vitamin E with mcg RAE for vitamin A, mcg for vitamin D, and mg a-tocopherol for vitamin E. In addition, in section II.J.2., we are proposing to quantify and declare folate and folic acid in ‘‘mcg DFE’’ instead of ‘‘mcg.’’ In the interest of maintaining consistency in nutrition labeling of foods and dietary supplements, we are proposing to amend § 101.36(b)(2)(i)(B)(3) to require that when b-carotene is included in parentheses following the percent statement for vitamin A, it should be declared using ‘‘mcg’’ (representing mcg RAE) as the unit of measure. In addition, under § 101.36(b)(2)(ii)(B), the proposed units of measure for vitamin D, vitamin E, and folate in § 101.9(c)(8)(iv) would be used in the declaration of vitamin D, vitamin E, and folic acid in the Supplement Facts label. In 2005, we received a citizen petition (Docket No. FDA–2005–P–0126 (formerly Docket No. 2005P–0293)) requesting us to preclude the declaration of b-carotene in VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 supplements as vitamin A (https:// www.regulations.gov/ # !docketDetail;D=FDA-2005-P-0126). The petition maintained that the declaration of vitamin A on dietary supplement labels is misleading when the supplement contains mostly bcarotene because only a small amount of b-carotene is converted by the liver into vitamin A. We do not see a need to preclude the declaration of b-carotene as vitamin A, because the difference in the bioconversion of b-carotene to vitamin A will be accounted for with the proposed declaration of vitamin A content as ‘‘mcg’’ (representing mcg RAE) (see section II.J.3.). Therefore, we are not proposing to preclude the declaration of b-carotene in dietary supplements as vitamin A. 4. Order of Nutrients Declared on the Label For dietary supplements, § 101.36(b)(2)(i)(B) specifies that vitamins and minerals must be declared in a specific order on the Supplement Facts label. We are now proposing to establish an RDI for choline in section I.7. Therefore, it is necessary to add choline to the list of ordered nutrients in § 101.36(b)(2)(i)(B). We are proposing to require that, when declared, choline shall follow potassium on the label. 5. Subpopulations We discussed several changes in section II.K. that will affect dietary supplement labeling currently required for infants, children under 4 years of age, and pregnant and lactating women. To maintain consistency with the proposed requirements for nutrition labeling of foods in § 101.9, we tentatively conclude that it is appropriate to revise the appropriate sections of § 101.36 that pertain to labeling requirements for foods, other than infant formula, that are represented or purported to be specifically for infants 7 through 12 months, children 1 through 3 years, and pregnant and lactating women. Therefore, we are proposing to amend § 101.36(b)(2)(iii) to read as follows: ‘‘The percent of the Daily Value of all dietary ingredients declared under paragraph (b)(2)(i) of this section shall be listed, except that the percent DV for protein may be omitted as provided in § 101.9(c)(7); no percent DV shall be given for subcomponents for which DRVs have not been established (e.g., sugars).’’ When the percent DV is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein, we require that a symbol be placed next to the percent DV declaration for these nutrients that refers the consumer to a PO 00000 Frm 00069 Fmt 4701 Sfmt 4702 11947 statement at the bottom of the label that says ‘‘Percent Daily Values are based on a 2,000 calorie diet.’’ This statement is only accurate for products meant for children and adults that are 4 years of age and older. The proposed DRVs for total fat, total carbohydrate, dietary fiber, and protein for children 1 through 3 years of age are based on a 1,000 calorie diet. Therefore, when a product that is represented or purported to be for children 1 through 3 years of age contains a percent DV declaration for total fat, total carbohydrate, dietary fiber, or protein, we are proposing to require in § 101.36(b)(2)(iii)(D) that a symbol be placed next to the percent DV declaration that refers the consumer to a statement at the bottom of the label that says ‘‘Percent Daily Values are based on a 1,000 calorie diet.’’ In addition, we are proposing to amend § 101.36(b)(2)(iii)(E) to change the categories of infants and children less than 4 years of age to infants 7 through 12 months of age and children 1 through 3 years of age. Finally, because we are proposing DRVs for various nutrients for infants 7 through 12 months, children 1 through 3 years, and pregnant and lactating women (see section II.K.), we are proposing to amend § 101.36(b)(2)(iii)(F) such that the requirement for an asterisk noting that a DV has not been established would be applicable to foods for these subpopulations only when a DRV has not been established for a nutrient (i.e., for saturated fat, cholesterol, or dietary fiber for dietary supplements that are represented or purported to be for use by infants 7 through 12 months). Proposed § 101.36(b)(2)(iii)(F) states: ‘‘For declared subcomponents that have no DRVs, a symbol (e.g., an asterisk) shall be placed in the ‘‘Percent Daily Value’’ column that shall refer to the same symbol that is placed at the bottom of the nutrition label, below the last heavy bar and inside the box, and followed by the statement ‘‘Daily Value not established.’’ 6. Footnote As discussed in section II.M, we are proposing to modify the footnote on the Nutrition Facts label. We are planning to conduct consumer studies related to the footnote on the Nutrition Facts label. The current footnote statement required for the Supplement Facts label differs from that which is currently required on the Nutrition Facts label. We expect that consumers that purchase dietary supplements would be more interested in information about the amount of specific micronutrients contained in dietary supplements and would be less E:\FR\FM\03MRP2.SGM 03MRP2 11948 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 focused on the caloric reference value used in determining the percent DV for macronutrients. Based on the results of the consumer study, we will consider whether it is necessary to make corresponding changes to the footnote used on the Supplement Facts label when certain macronutrients are declared. We invite comment on whether we should consider changes to the footnote statement on the Supplement Facts label to be consistent with any changes to the footnote statement in the Nutrition Facts label. M. Format Nutrition information must be presented on food labels in a specific format (see e.g., § 101.9(d)–(f) and (j)). The elements of format related to the Nutrition Facts label include such features and graphic design principles as the type style (i.e., font) and size of the type (i.e., point); use of boldface, lines, and bars; arrangement of information in one or more columns; column headings; presence of a footnote and use of a symbol (such as an asterisk) to designate a footnote; and whether nutrition information is listed as a percentage or in absolute (i.e., quantitative) amounts. The elements of format also include the alignment of information; whether indentations are used in listing nutrient data; and the use of white space (or negative space) where no image or text exists. White space helps to isolate an element of the label that demands attention and provides a hierarchy and pacing of information for the reader (Ref. 160). The format may differ from package to package according to the amount of space on the package that is available for labeling, as described and detailed in the relevant sections in this document. The format of the Nutrition Facts label was informed by a number of factors, including consumer research conducted by FDA (Refs. 161 to 163); consideration of the environment in which consumers typically use the label (i.e., grocery stores); the diversity of consumers for whom the label is intended (i.e., with respect to education, age, socioeconomic status, etc.); and comments and data received on this issue in response to a 1990 proposed rule, as discussed in the 1993 final rule entitled Food Labeling: Mandatory Status of Nutrition Labeling and Nutrient Content Revision, Format for Nutrition Label (58 FR 2079 at 2114– 2144) (the format rule). Research studies consistently confirmed that simple formats are easier to comprehend and require less consumer effort than complex information formats. A simple format is one that minimizes clutter and VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 best meets the NLEA requirements that nutrition information should enable the public to readily observe and comprehend such information. In addition, a simple format allows consumers to search for accurate nutrition information with minimum effort, and provides information in a succinct manner that maximizes understanding. Although the original intent of the format rule to meet the requirements and objectives of the NLEA for format has not changed, FDA is proposing certain changes to the format because of new information that has become available to us since 1993. The new information includes results of consumer research including studies that we conducted (Ref. 164), trends in health conditions (especially obesity), comments received in response to the 2005 and 2007 ANPRMs, and recommendations from FDA’s Obesity Working Group (OWG) (Ref. 165). We are using this notice of proposed rulemaking to re-examine aspects of the current label format to determine which, if any, design changes may facilitate how information is conveyed to consumers. We are not proposing an extensive reformatting of the Nutrition Facts label. The original design, which took into account fundamental design principles for communicating complex ideas with clarity, precision, and efficiency, are largely being retained (Ref. 166). Rather, our tentative views, tentative conclusions, and proposed changes include our consideration of graphic design principles such as alignment, consistency, repetition, and contrast, and place an emphasis on highlighting key nutrients and key information and removing or modifying parts of the label to assist consumers in maintaining healthy dietary practices (Ref. 167). We consider our proposed changes to the Nutrition Facts label to be visually appealing and inviting. In general, the goal is to continue to display the information in a simple manner that is legible, readable, and follows a logical hierarchy. This presentation should serve as a visual guide to the reader that allows the eye to easily scan the label while the actual effort of reading is reduced. Toward that end, we are proposing the following changes to the format of the Nutrition Facts label: (1) Increasing the prominence of calories and serving size; (2) reversing the order of the ‘‘Serving Size’’ declaration and the ‘‘Servings Per Container’’ declaration and increasing the prominence of ‘‘Servings Per Container’’; (3) rightjustifying the quantitative amounts of PO 00000 Frm 00070 Fmt 4701 Sfmt 4702 the serving size information; (4) changing the phrase ‘‘Amount Per Serving’’ to ‘‘Amount Per ll’’ with the blank filled in with the serving size; (5) removing the declaration of ‘‘Calories from fat’’; (6) modifying the presentation of the ‘‘% DV’’ information by changing its position to the left of the name of the nutrient on certain labels, and separating it from the list of nutrients with a vertical line; (7) declaring ‘‘Added Sugars’’ as an indented listing directly beneath the listing for ‘‘Sugars’’; (8) declaring the quantitative amounts (in addition to percent DVs) of mandatory vitamins and minerals and, when declared, voluntary vitamins and minerals; (9) requiring dual column labeling under certain conditions; (10) modifying the footnote; (11) requiring that all nutrients not currently highlighted in bold or extra bold type be highlighted in a type that is intermediate between bold or extra bold and regular (i.e., semi-bold) type; (12) adding a horizontal line directly beneath the ‘‘Nutrition Facts’’ heading; and (13) replacing the listing of ‘‘Total Carbohydrate’’ with ‘‘Total Carbs.’’ We discuss each of these proposed amendments in this document. In addition, we are requesting comments on other issues related to the Nutrition Facts label format, including the use of an alternative format design or requiring the use of a specific font. Although the discussion in this document focuses primarily on the format of the standard Nutrition Facts label illustrated in § 101.9(d)(12), we also discuss certain modifications that we are proposing to be applied to other label formats to maintain consistency with the new format of the standard Nutrition Facts label. These other modifications pertain to formats for packages of products that contain two or more separately packaged foods that are intended to be eaten individually (e.g., variety packs of cereals and snacks) or that are used interchangeably for the same type of foods (e.g., round ice cream containers (§ 101.9(d)(13)); formats that apply to subpopulations (§ 101.9(e) and § 101.9(j)(5)); the simplified format (§ 101.9(f)); the tabular display on packages that do not have sufficient continuous vertical space (§ 101.9(d)(11)(iii)); and the tabular display (§ 101.9(j)(13)(ii)(A)(1)) and linear display (§ 101.9(j)(13)(ii)(A)(2)) for small packages. 1. Increasing the Prominence of Calories and Serving Size The ability to determine the caloric content of packaged foods is important for all consumers, especially those who are trying to control their total caloric E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules intake and manage their weight. Inasmuch as overweight and obesity are major public health problems in the United States and are fundamentally a direct result of calorie consumption exceeding energy expenditure, we are interested in increasing consumer attention to the calorie content of packaged foods. Current FDA regulations require ‘‘Calories’’ to be declared in a type size no smaller than 8 point (§ 101.9(d)(1)(iii)) and highlighted in bold or extra bold type or other highlighting (§ 101.9(d)(1)(iv)). While calorie information is mandatory on the Nutrition Facts label, it is possible that modifying the Nutrition Facts label to give more prominence to calories may benefit consumers in weight control and maintenance, as noted by the OWG in its final report entitled ‘‘Calories Count’’ (Ref. 165). The OWG recommended, in part, that FDA issue an ANPRM to solicit comments on how to give more prominence to calories on the food label. The OWG suggested possible changes to the Nutrition Facts label, such as increasing the prominence of ‘‘Calories’’ and ‘‘Serving Size,’’ providing a percent DV for calories, and eliminating the ‘‘Calories from fat’’ declaration, which may detract from the emphasis on total calories. The OWG recommended that we obtain information on the effectiveness of these options on consumer understanding and behavior related to calorie intake (Ref. 165). After issuing the 2005 ANPRM, in which we solicited comment on the OWG recommendations, we received several comments that generally supported increasing the prominence of calories on the Nutrition Facts label. These comments suggested various approaches for doing so, and pointed out the need for additional research to fully understand the effects of potential label changes on consumer understanding and behavior (Ref. 47). We considered available data from consumer research and comments received in response to the ANPRMs. Research conducted for warning labels and drug label formats has consistently demonstrated that increasing type size, among other things, increases attention to, and improves understanding of warning information, especially for older consumers and those with limited vision (Refs. 168 to 170). Also, our research on food labels with two servings per container found that labeling changes that highlighted the number of servings per container (via text or a dual column) served as cues to consumers that the product contained more than one serving and helped them VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 more accurately determine the number of calories per container (Ref. 164). We tentatively conclude that the proposed changes to the number of calories per serving and the number of servings per container would result in these declarations serving as an anchor to the Nutrition Facts label by focusing the reader’s attention to this information and therefore would assist consumers to effectively use this information in the Nutrition Facts label (Ref. 171). Accordingly, we are proposing to revise § 101.9(d) to increase the type size for ‘‘Calories’’ and the numeric value for ‘‘Calories.’’ We are also proposing that the numeric value for calories be highlighted in bold or extra bold type in order to draw attention to this information, emphasize the importance of calories on the label, and maintain consistency with the bolded declaration for ‘‘Calories.’’ We invite comment on these tentative conclusions. We also consider it appropriate to make corresponding changes to the prominence of calories on the Supplement Facts label, when ‘‘Calories’’ is declared. Although the majority of dietary supplement products contain a negligible amount of calories, and therefore calories are not declared on most Supplement Facts labels, we note that some dietary supplement products may contain a significant amount of calories and macronutrients. We are concerned that a small number of dietary supplement products, especially those in liquid form, could contribute a significant amount of calories and other macronutrients to the diet when consumed regularly. For such products, our tentative view is that it may be necessary for the Supplement Facts label to have a format similar to the format being proposed for the Nutrition Facts label with respect to increasing the prominence of information for calories. We invite comment on whether any of the changes that are being proposed to the Nutrition Facts label in the following sections should also be required for certain products with Supplement Facts labels that list calories and/or other macronutrients, and if so, under what conditions and for which dietary supplement products should such labeling be required. 2. Changing the Order of the ‘‘Serving Size’’ and ‘‘Servings Per Container’’ Declarations and Increasing the Prominence of ‘‘Servings Per Container’’ Current regulations specify that information on serving size, consisting of a statement of the serving size (§ 101.9(d)(3)(i)) and the number of servings per container (§ 101.9(d)(3)(ii)), PO 00000 Frm 00071 Fmt 4701 Sfmt 4702 11949 shall immediately follow the identifying heading of ‘‘Nutrition Facts.’’ In addition, ‘‘Serving Size’’ and ‘‘Servings Per Container’’ must be in a type size no smaller than 8 point (§ 101.9(d)(1)(iii)). As mentioned previously, we are interested in taking steps to increase consumer attention to the calorie content in packaged foods, such as by increasing the prominence of this information as suggested by the OWG. Consumer research on information displays suggests that accuracy of judgments and quality of decisions are improved when information displays closely match the judgment and decision needs of consumers (Refs. 172 and 173). With respect to the Nutrition Facts label, an important consumer need is to identify the number of servings per container of a packaged food. Therefore, placing ‘‘Servings Per Container’’ above ‘‘Serving Size’’ would be expected to help consumers find the number of servings per container with less effort than is now needed. Listing ‘‘ll servings per container’’ with the blank filled in with the actual number of servings directly beneath the ‘‘Nutrition Facts’’ heading, and highlighting it in bold or extra bold type would also help increase awareness that the information presented in the Nutrition Facts label does not refer to the contents of the entire package when the label indicates that there is more than one serving per container. Further, listing ‘‘Serving size’’ in the same proximity to where the actual nutrient information is located on the label would help consumers understand that this nutrient information pertains to the particular serving size that is declared. Proximity is a graphic design principle that asserts that items closer together are perceived to be more related (Ref. 167). This, in turn, would help consumers grasp the relative significance of a particular food product in the context of their daily diet. Therefore, based on the available data and information discussed previously, including graphic design principle, of proximity we tentatively conclude that reversing the order of the declarations of ‘‘Servings Per Container’’ and ‘‘Serving Size’’ would help consumers more readily observe and comprehend the nutrition information appearing in the Nutrition Facts label, allow consumers to search for information with a minimum of effort, and assist consumers in their food purchasing decisions and in maintaining healthy dietary practices. Accordingly, we are proposing to re-designate § 101.9(d)(3)(i) as § 101.9(d)(3)(ii), re-designate § 101.9(d)(3)(ii) as § 101.9(d)(3)(i), and E:\FR\FM\03MRP2.SGM 03MRP2 11950 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 make changes in how the serving size information is capitalized on the label so that no capital letters are used, except for the first letter in ‘‘Serving size.’’ (Current § 101.9(d)(3)(i) and (d)(3)(ii) specify that information on serving size be capitalized and listed as ‘‘Serving Size’’ and ‘‘Servings Per Container.’’) We also are proposing to require that the declaration of ‘‘ll servings per container’’ (with the blank filled in with the actual number of servings) be highlighted in bold or extra bold type, and be in a type size no smaller than 11 point (except for the tabular and linear displays for small packages) (proposed § 101.9(d)(3)(i)) and that the serving size information must be in a type size no smaller than 8 point (except for the linear display for small packages) (proposed § 101.9(d)(3)(ii)). We tentatively conclude that these proposed changes would lessen the effort of consumers to locate this information, and assist them in accurately identifying the calorie amounts and nutrient contents of packaged food products. Current regulations regarding serving size information for dietary supplements is described in § 101.36(b)(1). When taking dietary supplements, consumers need to know how much of the product to take (e.g., 1 capsule, 2 tablets, 1 packet). This information, which is currently provided in the ‘‘Serving Size’’ line of the Supplement Facts label, is more important for the consumer to know than the number of servings (e.g., 100 tablets) contained in the package. We received no comments recommending that the serving size or servings per container information on the Supplement Facts label should be made more prominent or noticeable. Therefore, our tentative conclusion is that there is no need to propose changing the order of how serving size and servings per container are listed on the Supplement Facts label, or to make amendments in the type size or capitalization corresponding to our proposed changes for this information on the Nutrition Facts labels. We invite comment on these tentative conclusions. 3. Right-Justifying the Quantitative Amounts Declared in the ‘‘Serving size’’ Statement We have also tentatively concluded, based on design considerations, that the label statement for ‘‘Serving size’’ in both household unit (§ 101.9(b)(5), refers to a common household measure such as a cup, tablespoon, piece or slice) and gram amounts must be rightjustified on the same line that ‘‘Serving size’’ is listed. Currently, this numerical VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 information is stated immediately adjacent to the ‘‘Serving Size’’ declaration, as seen in current § 101.9(d)(12). By keeping the proposed ‘‘Serving size’’ declaration left-justified while right-justifying the corresponding numerical values, the proposed change would create white space on the Nutrition Facts label that would result in a less cluttered appearance, heightened focus and emphasis, and improved readability (Ref. 160). This design feature would provide enhanced emphasis to the information about serving size, allowing this information to be more noticeable and thereby facilitating its access and use by consumers. We invite comment on this tentative conclusion. 4. Changing the ‘‘Amount Per Serving’’ Statement Current regulations specify that the Nutrition Facts label shall include a subheading designated as ‘‘Amount Per Serving’’ and that this subheading shall be separated from the serving size information by a bar (§ 101.9(d)(4)) and be highlighted in bold or extra bold type or other highlighting (§ 109(d)(1)(iv)). We are proposing, based in part on the consumer research previously cited (Refs. 172 and 173), to change the ‘‘Amount Per Serving’’ declaration to ‘‘Amount per ll’’ with the blank filled in with the actual serving size expressed in household units, and to increase the type size. These changes would make it easier for label users to judge the amounts of nutrients per serving because it removes the need for label users to refer back to the unit of the serving size which is currently declared just below the Nutrition Facts heading and which would be declared under the number of servings per container in the proposed label formats. Other studies suggest that consumers are often confused by serving size information as it is currently presented on the Nutrition Facts label (Refs. 174 and 175). Therefore, specifying the actual serving size in the listing of ‘‘Amount per ll’’ declaration would be expected to help consumers more readily observe and comprehend the nutrition information appearing in the label. Based on the reasons provided, we tentatively conclude that changing the ‘‘Amount Per Serving’’ statement to ‘‘Amount per ll’’ with the blank filled in with the actual serving size and increasing the type size would assist consumers in using the information and may lessen the time and effort needed to locate the target information. Accordingly, we are proposing to amend § 101.9(d)(4) by requiring that the Nutrition Facts label specify what the PO 00000 Frm 00072 Fmt 4701 Sfmt 4702 serving size actually is by declaring ‘‘Amount per ll’’ with the blank filled in with the actual serving size in household units as indicated in the ‘‘Serving size’’ declaration. To further facilitate use of the Nutrition Facts label, as mentioned in section 2, we are proposing to move the ‘‘Serving size’’ declaration closer to the proposed ‘‘Amount per ll’’ listing. We also are proposing to require that the ‘‘Amount per ll’’ information be highlighted in semi-bold, rather than in bold or extra bold, in order not to detract from the calories information. In addition, we are proposing that the type size of the ‘‘Amount per ll’’ declaration be no smaller than 8 point (except for the linear display for small packages). We invite comment on our tentative conclusions. 5. Declaration of ‘‘Calories from Fat’’ We have tentatively concluded that a declaration of calories from fat on the Nutrition Facts label is not necessary to assist consumers in maintaining healthy dietary practices and, consequently, we are proposing to remove the current requirement for declaration of ‘‘Calories from fat’’ (see section II.A.1.). Our Consumer research (Ref. 164), which evaluated a label format that did not contain the ‘‘Calories from fat’’ statement, found that the lack of this information had no effect on consumers’ judgments of product healthfulness, accuracy in identifying nutrient contents of products, or perceptions of the label. These findings support our proposal to remove the ‘‘Calories from fat’’ declaration from the Nutrition Facts label. 6. Presentation of Percent DVs The format for listing nutrients with DRVs on the Nutrition Facts label, including the quantitative amount by weight and percent DVs, is described in § 101.9(d)(7). In establishing the requirements for percent DV declaration, we considered that this information would help consumers evaluate the nutrient characteristics of a single product (e.g., how high or low a particular product is in certain nutrients or the extent to which it contributes toward daily nutritional goals) and assist them in making choices between products (58 FR 2079 at 2121). Consumer research at that time of rulemaking for the Nutrition Facts label (Ref. 162) indicated that the percent DV information improved consumers’ abilities to make correct dietary judgments about a food in the context of a total daily diet. Research also indicated that percent DV information helped consumers to verify the accuracy E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules of front-panel claims (Ref. 163). We received comments on the format of the Nutrition Facts label in response to the 2007 ANPRM (Ref. 47) that suggested modifying the way percent DV is presented to facilitate greater use of this information, although one comment suggested that the percent DV should not be used on the label. Other comments noted the need for additional consumer research and a comprehensive consumer education program. We continue to believe that the percent DV information on the Nutrition Facts label can serve a number of useful purposes, including helping consumers to compare foods; determine if a serving of food is high or low in a particular nutrient; and make dietary trade-offs among food choices throughout the day. As such, we do not agree that the percent DV declarations should be eliminated from the Nutrition Facts label. We are proposing to switch using the ‘‘% Daily Value’’ to the ‘‘% DV’’ in the column that is above the nutrient listings. The ‘‘% DV’’ is used on some of nutrition facts labels for smaller packages and we think this will help with maintaining consistency among the labels. In addition we are adding a hairline rule (see discussion in this document) to differentiate the DVs from the nutrients and using ‘‘% DV’’ as the header which maintains the alignment of the heading over the DV column. Therefore based on the graphic design principle of alignment (Ref. 167) and in order to promote consistency of the labels we tentatively conclude to use ‘‘% DV’’ as the column header over the numerical listing of the nutrients DVs (proposed § 101.9(d)(7)(ii)) . We have considered alternative terms that may be more readily understandable than Daily Value, such as Daily Guide or Daily Need, and invite comment on these or other terms. The issue of using an appropriate single term to refer to all of the reference values in the nutrition label was previously discussed in the format rule (58 FR 2079 at 2124), in which we explained our rationale for deciding upon the single term ‘‘Daily Value.’’ We also request comment on whether the word ‘‘percent’’ (or the % symbol) should precede whatever term is used in the column heading where the percent DVs are listed, as specified in current § 101.9(d)(6). Since the % symbol is currently included next to the numerical values that are listed in this column, including the word ‘‘percent’’ or the % symbol in the column heading may be redundant and, after considering comments, we may remove that requirement in a final rule. For the reasons explained previously, we are VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 not proposing to change the requirements for the declaration of percent DV for all nutrients, as specified in § 101.9(c)(8) and § 101.9(d)(7). As discussed previously, percent DV is intended to help consumers make dietary decisions. Therefore, we tentatively conclude that making the percent DV more prominent may make the information even more useful to consumers than it is now. One potential approach to making the percent DV more prominent is to rearrange the positions of the columns listing the percent DV information. As currently described in § 101.9(d)(6), and § 101.9(d)(7) the percent should be arranged on the right of certain Nutrition Facts label formats. For labels displaying the tabular format (proposed § 101.9(d)(11)(iii)), the standard format (proposed § 101.9(d)(12)), the format for infants 7 to 12 months of age (proposed § 101.9(j)(5)(i)), the tabular format for small packages, (proposed § 101.9(j)(13)(ii)(A)(1)), the linear display (proposed § 101.9(j)(13)(ii)(A)(2)), and the simplified format (as described in current § 101.9(f)), we propose to list percent DVs in a column to the left of the names of the nutrients and their quantitative amounts, with a thin vertical line separating the ‘‘% DV’’ column from the list of nutrients. The rearrangement is based on the graphic design principles of primacy (which asserts that initial items in a list are stored more efficiently in memory than items listed later), proximity (which asserts that elements positioned close together are perceived as a single group), and the importance of white space (which, among other things, is used by designers to isolate an element that demands attention) (Ref. 160 and 167), and the fact that English text is read from left to right. The addition of a vertical hairline rule to the right of the ‘‘% DV’’ column assists in chunking this information, thereby accentuating it and further distinguishing it from the nutrient name and the quantitative weight information. Chunking is a technique for combining multiple units of information into a limited number of units or chunks so that the information is easier to process and remember) (Ref. 167). Based on these design principles, positioning the % DV to the left of the label should increase consumers focus on the % DV. Displaying the % DV in this manner would assist consumers in understanding the relevant contribution of a nutrient in a food to the diet by highlighting the % DV information on the label more than on the current label format (where % DV is listed on the right of the label). PO 00000 Frm 00073 Fmt 4701 Sfmt 4702 11951 We tentatively conclude that the proposed rearrangement would assist consumers by helping them to understand the nutrition information on the label in the context of a total daily diet. We are unaware of any consumer survey data concerning this particular proposed change related to consumer understanding and use of the information. Although, we are aware that the prevalence of inadequate numeracy (defined as ‘‘the ability to comprehend, use, and attach meaning to numbers’’ (Ref. 176) and low literacy in the population have been persistent concerns regarding the ability of consumers to comprehend healthrelated information, it is unclear to what extent the changes we are proposing to the positioning of the % DV from its current placement would have on overall consumer use or understanding. We are also aware that the prominence of the percent DV first could potentially make the Nutrition Facts label appear less user-friendly particularly to frequent users of Nutrition Facts labels, who have grown accustomed to the format and organization of the existing Nutrition Facts label. In addition, we acknowledge that moving the % DVs to the left could potentially draw consumer attention from nutrients that do not have a DV. We invite comment and data on the tentative conclusion to shift the ‘‘% DV’’ to the left of the Nutrition Facts label. On all dual column labels, including those (1) for two or more forms of the same food (proposed § 101.9(e)(5)); (2) displaying nutrition information per container and per unit, in addition to nutrition information per serving (proposed § 101.9(e)(6)(i); (3) using the tabular display (proposed § 101.9(e)(6)(ii)), and; (4) that provide the aggregate display (proposed § 101.9(d)(13)(ii)), we propose to list the names of nutrients on the right side of the % DV column, followed by the quantitative (weight) amounts of each nutrient. In each of these labels, we propose to use thin vertical lines to separate the information in the ‘‘% DV’’ column from the information in the column containing the quantitative weights. Further, we propose to use the same style of thin vertical lines to separate each of the dual columns and aggregate display columns from each other. The use of these vertical lines helps to differentiate the columns and make the information easier for consumers to read and identify (Ref. 167). We invite comment on this tentative conclusion. As described in the Dietary Supplement Health and Education Act of 1994, dietary supplements are E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11952 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules products taken by mouth containing ‘‘dietary ingredients’’ that are intended to supplement the diet. They may contain not only vitamins and minerals, but also herbs or other botanicals and amino acids, as well as concentrates, metabolites, constituents, and extracts of these dietary ingredients (section 201(ff) of the FD&C Act). Thus, many dietary supplement products contain few or no dietary ingredients with DRVs or RDIs, and therefore would not list any percent DVs on the Supplement Facts label. Further, consumers taking dietary supplements may find information about the quantitative amounts of dietary ingredients in the product to be of equal or greater importance than a percent DV listing, even if a DV existed for an ingredient contained in the dietary supplement. Therefore, we are not proposing any changes in the position of the percent DV listing on the Supplement Facts label relative to the position of the nutrient and dietary ingredient information. As mentioned previously, we are proposing to require that the Nutrition Facts labels that include dual columns contain vertical lines separating the percent DV information from the quantitative amounts per weight listings in each of the dual columns, and to separate the dual columns from each other. We invite comment on whether there is a need to include vertical lines that are similarly placed on Supplement Facts labels for multiple vitamins in packets (§ 101.36(e)(11)(iii)) and for dietary supplements that list ‘‘per serving’’ and ‘‘per day’’ information (§ 101.36(e)(11)(viii)). Current § 101.9(j)(5)(ii)(A), (j)(5)(ii)(C), and (j)(5)(ii)(D) include certain provisions for the presentation of percent DV for nutrients on the Nutrition Facts label of foods represented or purported to be specifically for infants and children less than 4 years of age. In particular, the percent DVs for protein, vitamins, and minerals are listed in a separate section of the Nutrition Facts label below the quantitative information by weight for protein. As discussed in section II.K., we are proposing changes to the nutrition labeling of foods represented or purported to be specifically for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women. These include, among other things: (1) Establishing RDIs and DRVs that are used in determining the percent DVs declared on the label; and (2) allowing for certain percent DV declarations that are currently excluded in § 101.9(j)(5)(ii)(A). Given these VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 proposed amendments that would require percent DV declarations for macronutrients, we invite comment on the appropriate placement of percent DVs in the labeling of foods for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women. We are considering listing the percent DV to the left of the name of any nutrient that has a DV, as shown in proposed § 101.9(j)(5)(i), similar to the placement of the declaration of percent DVs in the labeling of foods for the general population. Therefore, we are proposing that the percent DV for protein would no longer be listed with the vitamins and minerals at the bottom of the label as currently required. 7. Placement of ‘‘Added Sugars’’ As discussed in section II.D.3., we are proposing to require the declaration of added sugars as an indented line item underneath the declaration of total sugars on the Nutrition Facts label. If finalized, added sugars would be the first mandatory nutrient required to be listed in a double indentation format on the Nutrition Facts label. FDA regulations permit the voluntary declaration of ‘‘soluble fiber’’ and ‘‘insoluble fiber’’ as double indented listings under ‘‘dietary fiber’’ (§ 101.9(c)(6)(i)). We are planning to conduct a consumer study (78 FR 32394, May 30, 2013) that will include, among other things, questions regarding the declaration of added sugars on the Nutrition Facts label. The results of this study will help enhance our understanding of how consumers would comprehend and use this new information. We will publish the results of the study when they become available. We are interested in receiving, as part of any comment, other available research data and other factual information relevant to this issue, including the proposed double indented placement of added sugars below total sugars. 8. Declaration of Absolute Amounts of Vitamins and Minerals A declaration of the quantitative amount by weight is required for both mandatory and voluntary nutrients that are declared on the Nutrition Facts label, except for vitamins and minerals (other than sodium and potassium) which must be declared only as percent DVs. As discussed in section II.I.6., we are proposing to require the declaration of the absolute amounts for all mandatory and voluntary vitamins and minerals, in addition to the requirement for percent DV declaration. An exception to this proposed requirement PO 00000 Frm 00074 Fmt 4701 Sfmt 4702 would be Nutrition Facts labels for foods in small packages that have a total surface area available to bear labeling of 40 or less square inches. Because of space limitations, we are not proposing any changes to the tabular display (§ 101.9(j)(13)(ii)(A)(1)) and the linear display (§ 101.9(j)(13)(ii)(A)(2)) on packages that have a total surface area available to bear labeling of 40 or less square inches, where vitamins and minerals (other than sodium) would have to be declared only as percent DVs. 9. Single and Dual Column Labeling There are currently multiple provisions for voluntary dual column labeling. For example, there is dual column labeling that presents nutrition information per serving size and per 100 g or 100 mL, or per 1 oz. or 1 fl oz. of the food as packaged or purchased (§ 101.9(b)(10)(i)). Dual column labeling is mandatory for products that are promoted on the label, or in advertising, for a use that differs in quantity by twofold or greater from the use upon which the reference amount was based (e.g., liquid cream substitutes promoted for use with breakfast cereals) (§ 101.9(b)(11)). We are also proposing for foods that are commonly combined with other ingredients or that are cooked otherwise prepared before eating to present the percent DVs and the quantitative amounts for both the food in the ‘‘as purchased’’ form and for the ‘‘as prepared’’ form in § 101.9(h)(4). We are proposing under certain conditions (i.e., when the package contains at least 200 percent and up to and including 400 percent of the applicable reference amount customarily consumed) to require dual column labeling where nutrition information would be presented based both on the serving size and on the entire package or unit of food. This is described in a proposed rule entitled ‘‘Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments’’ (serving size proposed rule) that is published elsewhere in this issue of the Federal Register. In addition to proposing dual-column labeling per serving and per container (or unit, as applicable) for all nutrition information on the label, we are considering two additional options that would require nutrition information per serving and per container for only certain declarations but not all label declarations for containers of food or units of food, as applicable, containing E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 at least 200 percent and up to and including 400 percent of the applicable RACC. The first option is for a label that includes calorie information per serving and per container (or unit, as applicable) following the serving size information in the Nutrition Facts label. With this option, the remaining nutrition information would be listed on a per serving basis only and in a single column below the calorie information per serving and per container. The second option is to provide nutrition information per serving and per container (or unit, as applicable) for calories, saturated fat and sodium following the serving size information in the Nutrition Facts label and the remaining nutrition information would be listed on a per serving basis in a single column below the dual column provided for calories, saturated fat and sodium declarations. These options may specifically highlight the calorie content alone, and the calorie content, saturated fat content, and sodium content, respectively, for both the serving size and the entire container of food (or unit, as applicable). These options would focus on a smaller number of nutrients presented per serving and per container of food (or unit, applicable) that the U.S. population should limit for those foods with at least 200 percent and up to and including 400 percent of the RACC. We question whether consumers would be more inclined to use dual column labeling for a smaller set of nutrients. We invite comment and data on dual column labeling as proposed in this rule as well as the options presented for providing nutrition information per serving and per container (or unit, as applicable) for only certain declarations. We will consider whether to require one of these options in the serving size final rule after considering comments on the serving size proposed rule. 10. The Footnote The Nutrition Facts label requires an asterisk following the ‘‘% Daily Value’’ declaration that refers to a footnote statement that reads: ‘‘*Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be higher or lower depending on your calorie needs’’ (§ 101.9(d)(9)(i)). Below this footnote, a table that lists DRVs for total fat, saturated fat, cholesterol, sodium, total carbohydrate, and dietary fiber based on 2,000 and 2,500 calorie diets must be provided (§ 101.9(d)(9)(i)). This table was originally included in the Nutrition Facts label to assist consumers in estimating their own quantitative dietary needs relative to the reference DVs (58 FR 2079 at 2127). It was also intended to communicate that some DVs VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 vary with caloric intake whereas others do not. Specifically, only the DRVs for the macronutrients (i.e., total fat, saturated fat, total carbohydrate, dietary fiber, and protein) differ according to calorie needs while the current DRVs for cholesterol, sodium, and potassium, as well as the RDIs for essential vitamins and minerals, do not vary according to caloric intake, and therefore are the same for both the 2,000 and 2,500 calorie levels listed in the footnote. Finally, a statement indicating that the kcal/g for fat, carbohydrate, and protein are 9, 4, and 4, respectively, is permitted to be declared below the DRVs table (§ 101.9(d)(10)). Several comments to the 2007 ANPRM suggested deleting either the entire footnote or the DRVs table from the footnote, and stated that the footnote information is not readily useable or understood by consumers and may be potentially confusing. Other comments recommended replacing the footnote with a short, simple statement that directs consumers to the USDA’s MyPyramid Web site (which has now been replaced with ChooseMyPlate.gov) for further information. We do not agree with these latter comments, as information on the Nutrition Facts label should be available to the consumer at the time of product purchase or consumption. The percent DV is not described in the footnote or anywhere else on the Nutrition Facts label and we are interested in whether such a description would help improve consumer understanding of the percent DV information. In addition, as one comment pointed out, a recent study by the International Food Information Council Foundation entitled ‘‘Food Label and Consumer Research Project’’ showed that some consumers did not understand what was being conveyed in the percent DV explanatory footnote and others thought that the DRVs table changed according to the content of each food and beverage product. Therefore, although data indicate that the DRVs table is not well understood by consumers, it also appears unlikely that consumers would understand this information any better if calorie values were lowered or if a separate listing for men and women were provided, as was suggested by some comments. Therefore, we are proposing to remove the requirement for the footnote table listing the DRVs for total fat, saturated fat, cholesterol, sodium, total carbohydrate, and dietary fiber for 2,000 and 2,500 calorie diets that is specified in § 101.9(d)(9)(i). We also note that consumers are better able to discriminate between PO 00000 Frm 00075 Fmt 4701 Sfmt 4702 11953 more and less healthful products when they are given an explanation about percent DVs than when they are not (Ref. 177). Therefore, it is our tentative view that a new footnote statement containing informational text to help consumers interpret the meaning of the percent DV and use the DVs is needed. Such information may include a definition of the percent DV, a succinct statement regarding calorie intake, and/ or an explanation of when the percent DV signifies a relatively high or low level of a nutrient, such as the ‘‘5/20 rule,’’ which we describe in this document. In addition, it is our tentative view that such a footnote statement should be simple and easy to understand, as simplified information is more useful and accessible to consumers than complex information (Ref. 178). We also recognize that the footnote appearing in small type size at the bottom of the label may have made it less noticeable to consumers and therefore of less use than if it had been larger and otherwise more noticeable. Therefore, it is our tentative view that increasing the type size, bolding key elements of the footnote (space permitting), and adding a bar clearly separating it from the micronutrient information directly above will assist consumers in using the information. Again, we request comment on the impact such changes would have on enhancing consumers’ use of the percent DV. We will consider comments we receive and whether to include such changes in the final rule. We also consider that a succinct statement about daily calorie intake (2,000 calories) is a necessary part of the footnote because 2,000 calories is consistent with widely used food plans (76 FR 19192 at 19209), the percent DV of certain nutrients (e.g., total fat, total carbohydrate, and dietary fiber) is based on 2,000 calories, and 2,000 calories approximates the estimated energy need for adults who are sedentary to moderately active. However, we recognize that a succinct statement about daily calorie intake should not suggest that the percent DV of all nutrients is linked to a 2,000 calorie diet. As previously discussed in section II.M.7, we are planning to conduct consumer research on various format issues, including percent DV information in the footnote area. We agree that consumer education programs are important, and have offered such programs on our Web site to a variety of audiences, including young individuals (Ref. 179). We will consider additional efforts, as appropriate. In an E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11954 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules effort to provide consumers with a general approach for using the percent DV to evaluate the nutrient content in foods, we have explained on our Web site that, as a general frame of reference, a 5 percent DV or less is low and a 20 percent DV or more is high (often called the ‘‘5/20 rule’’) (Ref. 180). Even though this general frame of reference has been publicized and advocated by the 2010 DGA (Ref. 6) and various Web sites (Ref. 181), it is unclear whether consumers are aware of the ‘‘5/20 rule,’’ and to what extent it can improve consumer judgments about what constitutes high or low levels of nutrients in foods since quantitative information about food constituents is difficult for consumer to interpret (Ref. 180). The ‘‘5/20 rule’’ also closely approximates FDA regulations for nutrient content claims that provide criteria for the terms ‘‘low’’ (§§ 101.61 and 101.62) and the terms ‘‘rich in’’ and ‘‘excellent source’’ (§ 101.54). Thus, the ‘‘5/20 rule’’ could assist consumers in choosing foods that are high in specific nutrients they want to consume more of (e.g., calcium) and/or low in nutrients they want to eat less of (e.g., saturated fat). To inform our decision on how best to construct the new footnote, including its content and format, we plan to conduct consumer research during this rulemaking that will test consumer reactions to a definition of percent DV, a succinct statement on calories, and several statements related to the ‘‘5/20 rule’’ (77 FR 32120, May 31, 2012, and 78 FR 32394). We will make the results of this study available for public review and comment. We request comments, including available data and information (such as experimental evidence) related to this issue. We are not aware of data gathered since the NLEA’s implementation on whether listing information about converting gram amounts of fat, carbohydrate, and protein to calories has been useful to consumers. We are not proposing changes to this aspect of the footnote specified in § 101.9(d)(10). However, we request comments and supporting data on whether or not this calorie conversion information should continue to be optional on the Nutrition Facts label, and whether there are any data suggesting that consumers do or do not use this information. We may consider deleting this optional requirement in the final rule if we determine the information is not useful. We will consider corresponding changes to the footnote requirements for the Supplement Facts label consistent with any changes to the footnote on the Nutrition Facts label. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 11. Use of Highlighting With a Type Intermediate Between Bold or Extra Bold and Regular Type Currently, only nutrients that are not indented (i.e., ‘‘Calories,’’ ‘‘Total Fat,’’ ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total Carbohydrate,’’ and ‘‘Protein’’) on the Nutrition Facts label are required to be highlighted in bold or extra bold type or other highlighting (§ 101.9(d)(1)(iv)). We have tentatively concluded, based on design considerations of highlighting information in Bold type (Ref. 167) would help differentiate the name of the nutrient from its absolute amount, that all of the other nutrients listed on the Nutrition Facts label, including those that are indented and the vitamins and minerals, should also be highlighted in order to set them apart from other information that appears in the Nutrition Facts label. The key nutrients that are not indented above would still be highlighted in a font that is bolder than the indented nutrients, so the overall style of the Nutrition Facts label will not change. Accordingly, we are proposing to amend § 101.9(d)(1)(iv) to remove the restriction that prohibits any other information on the label to be highlighted, and to require that all voluntary nutrients specified in § 101.9(c), including the vitamins and minerals listed in § 101.9(c)(8)(iv), appear in a type intermediate between bold and regular type (if bold type is used) or between extra bold and regular type (if extra bold type is used) on the Nutrition Facts label. 12. Addition of a Horizontal Line Beneath the Nutrition Facts Heading The current label requires that the Nutrition Facts heading be set in a type size larger than all other print size in the nutrition label (§ 101.9(d)(2)) but does not require that this heading be set apart from the rest of the label with a horizontal hairline rule, which is a thin line. Horizontal lines are used throughout the Nutrition Facts label as a key graphic element to divide space, direct the eye, and give the label a unique and identifiable look. The repeated use of horizontal lines helps develop the organization of the label, strengthens the label’s unity, accentuates width, and promotes stability (Ref. 182). The addition of a hairline rule immediately below the Nutrition Facts heading directs the reader’s eye to the serving size information, further emphasizes the information about servings, and helps break the information into small chunks, thus making it easier to process and remember the information (Ref. 167). Accordingly, we have tentatively PO 00000 Frm 00076 Fmt 4701 Sfmt 4702 concluded that a 0.25 point hairline rule shall be inserted directly beneath the Nutrition Fact heading on all label formats, with the exception of the linear display for small packages. We invite comment on this tentative conclusion. 13. Replacing ‘‘Total Carbohydrate’’ With ‘‘Total Carbs’’ Nutrition information declared on the Nutrition Facts label must be presented using the nutrient names specified in § 101.9(c) or § 101.9(j)(13)(ii)(B). According to § 101.9(c)(6), the nutrient name used for listing information about the carbohydrate content of a product is ‘‘Total Carbohydrate.’’ Certain abbreviations, as specified in § 101.9(j)(13)(ii)(B), may be used on the Nutrition Facts label on packages that have a total surface area available to bear labeling of 40 or less square inches. In addition, the term ‘‘carb’’ is commonly used as a shortened term or acronym for ‘‘carbohydrate’’ (Ref. 183). Although the current abbreviation for ‘‘Total carbohydrate’’ is ‘‘Total carb,’’ we found that ‘‘total carbs’’ was extensively preferred over ‘‘total carb’’ as a Google search term during the past 15 years, suggesting that ‘‘carbs’’ is the more commonly used term by the general public (Ref. 184). As previously discussed, we are interested in maximizing the amount of white space on the Nutrition Facts label and in maintaining a simple format that minimizes clutter and enables the public to readily observe and comprehend the nutrition information that is presented. For the reasons set forth previously, we tentatively conclude that using the term ‘‘Total Carbs’’ instead of ‘‘Total Carbohydrate’’ would help achieve these objectives. Accordingly, we are proposing to amend § 101.9(c)(6) and § 101.9(j)(13)(ii)(B) by requiring that the total carbohydrate content in a serving be listed as ‘‘Total Carbs’’ instead of ‘‘Total Carbohydrate’’ or ‘‘Total Carb’’ and that this listing be used on all label formats. We invite comment on this tentative conclusion. 14. Alternative Visual Formats/Fonts We considered the utility of alternative visual presentation formats, in response to some comments that suggested using charts or graphs to facilitate consumer understanding (Ref. 47). During the development of the current label format, we examined alternative graphic designs, including graphs, and determined that the current format was optimal (Ref. 185). Since 1993, we reviewed two published studies that explored alternative graphical formats (Refs. 172 and 186). These studies provided limited and E:\FR\FM\03MRP2.SGM 03MRP2 mixed evidence in support of the tested formats. For example, one study (Ref. 186) did not investigate how graphical formats would perform when individuals have to compare the healthfulness of more than one product simultaneously. The other study (Ref. 172) demonstrated that when participants used the test labels to compare two products, the alternative graphical format was not unequivocally superior to a format resembling the standard Nutrition Facts format, and indeed the graphical display appeared to be inferior to the Nutrition Facts-type format in supporting consumers’ ability to calculate the number of servings of a food that would provide the daily value of particular nutrients. Therefore, in the absence of conclusive evidence to support alternative graphical layouts, we are not proposing any changes to the basic format of the Nutrition Facts label as specified in § 101.9(d)(12). However, we invite comment on an alternative concept for the Nutrition Facts label format that indicates ‘‘quick facts’’ (e.g., amount of total carbohydrate, fat and protein) about a product’s nutrient content first, and then explicitly points out nutrients to ‘‘avoid too much’’ of as well as nutrients to ‘‘get enough’’ of as a way to categorize the nutrient declarations in the Nutrition Facts label. We previously considered this concept of separating nutrients out on the label and would like to reconsider it (Ref. 163). We request comment on how this display may or may not convey the information in a manner which enables the public to readily observe and comprehend such information and whether separating and placing nutrients such as ‘‘ ‘‘Total Fat and ‘‘Saturated Fat’’ under different headings would help or hinder consumer’s understanding of the Nutrition Facts label. We are also interested in comments on what headings could be used and how to categorize all of the nutrients. Additionally, we are seeking comment on whether a specific type style should be required for the Nutrition Facts label. Currently, we specify in § 101.9(d)(1)(ii)(A) that the type style should be a ‘‘single easy-toread type style’’ but no specific type style is required. However, in § 101.9(d)(1) we urge that certain type styles (i.e., Helvetica Black, Helvetica Regular, Franklin Gothic Heavy) and other graphic design features be used, as described in appendix B to title 21, part 101, of the Code of Federal Regulations. We request comment on whether a specific font should be required to VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 ensure the readability of the Nutrition Facts label. N. Compliance Section 101.9(g) provides information about how we determine compliance with our nutrition labeling requirements, including the methods of analysis used to determine compliance, reasonable excesses and deficiencies of nutrients, and acceptable levels of variance from declared values. Based on the proposed changes to other sections of § 101.9 (discussed in sections II.A. to II.M.) and taking into account comments in response to the 2007 ANPRM, we are proposing several changes to § 101.9(g), which we discuss in this document. 1. Level of Variance Allowed for the Label Declaration of Specific Nutrients Section 101.9(g)(5) establishes that a food with a label declaration of calories, sugars, total fat, saturated fat, trans fat, cholesterol, or sodium shall be deemed to be misbranded under section 403(a) of the FD&C Act if the nutrient content PO 00000 Frm 00077 Fmt 4701 Sfmt 4702 11955 of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label. In addition, no regulatory action will be based on a determination of a nutrient value that falls above this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved. One comment to the 2007 ANPRM asked us to reevaluate the level of variance permitted for nutrient content declarations, particularly for added nutrients of concern such as sodium, sugar, and fat. Expressing concern that the current practice could result in the provision of inaccurate and misleading information to consumers, the comment recommended that if we are unable to reduce the amount of permitted variability, we should, at a minimum, require food processors to include a disclosure on the food label. In determining the allowances for variability in § 101.9(g), we considered variability in the nutrient content of foods, analytical variability inherent to test methods used to determine compliance, and statistical probability (38 FR 2125 at 2128, January 19, 1973). In addition, we evaluated compliance procedures and found them to be statistically sound and adequate. The comment provided no information to support a change to the current level of variance or the use of a disclosure statement in this context. Therefore, we are not proposing to change the level of variance allowed in § 101.9(g)(5) in response to the comment. 2. Methods Used To Determine Compliance Under § 101.9(g)(2), a composite of 12 subsamples, each taken from 12 different randomly chosen shipping cases are analyzed by appropriate methods as given in the ‘‘Official Methods of Analysis of the AOAC International,’’ 15th Ed. (1990) to determine compliance with the requirements in § 101.9, unless a particular method of analysis is specified in § 101.9(c). If no AOAC method is available or appropriate, we use other reliable and appropriate analytical procedures (see § 101.9(g)(2)). The current edition (19th Ed.) of the ‘‘Official Methods of Analysis of the AOAC International’’ includes many updates to the 15th Edition. When we issued § 101.9(g) related to compliance with nutrition labeling requirements, the most current version of the AOAC methods was its 15th edition and, therefore, we identified the 15th edition in our regulation. Newer and better methods of analysis have E:\FR\FM\03MRP2.SGM 03MRP2 ep03mr14.002</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 11956 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 been subsequently validated and recognized as ‘‘official’’ methods in the current 19th edition (2012) of the Official Methods of Analysis of the AOAC International. Accordingly, we are proposing to amend § 101.9(g)(2) by removing ‘‘15th Ed. (1990)’’ and adding in its place ‘‘19th Ed. (2012)’’ to specify that we will analyze composites ‘‘by appropriate methods as given in the ‘‘Official Methods of Analysis of the AOAC International,’’ 19th Ed. (2012).’’ If a newer edition of the Official Methods of the AOAC International is published before issuance of a final rule, and assuming that we issue a final rule, we intend to finalize this rule with the newer edition, as appropriate, provided there are no substantive changes in the newer edition requiring additional comment. 3. Records Requirements Current § 101.9(g)(2) sets forth requirements for composite sampling and analysis to determine compliance with labeling declarations. Specifically, unless a specific analytical method is identified by regulation, composites are analyzed by the appropriate AOAC method (15th Edition) or, if no AOAC method is available or appropriate, by other reliable and appropriate analytical procedures. For certain nutrients subject to this proposed rule, however, there is no AOAC official method of analysis or other reliable or appropriate analytical procedure that is available for us to verify the amount of the declared nutrient on the Nutrition Facts label and ensure that the declared nutrient amount is truthful, accurate and complies with all applicable labeling requirements, including the requirements in § 101.9(g). Specifically, there is no suitable analytical procedure available to measure the quantity of: (1) Added sugars (when a food product contains both naturally occurring sugars and added sugars and for specific foods containing added sugars, alone or in combination with naturally occurring sugars, where the added sugars are subject to fermentation); (2) dietary fiber (when a food product contains both non-digestible carbohydrate(s) that meets the proposed definition of dietary fiber and non-digestible carbohydrate(s) that does not meet the definition of dietary fiber); (3) soluble fiber (when a mixture of soluble fiber and added nondigestible carbohydrate(s) that does not meet the definition of dietary fiber are present in a food); (4) insoluble fiber (when a mixture of insoluble fiber and non-digestible carbohydrate(s) that does not meet the definition of dietary fiber are present in a food); (5) vitamin E (when a food product contains both VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 RRR-a-tocopherol and all rac-atocopherol acetate); and (6) folate (when a food product contains both folate and folic acid). As discussed in sections II.D.3. (added sugars), II.D.5.a. (dietary fiber), II.D.5.b. (soluble and insoluble fiber), II.J.2. (folate), and II.J.3. (vitamin E) Under current § 101.9(g)(9), FDA may permit the use of an alternative means of compliance or additional exemptions when it is not technologically feasible, or some other circumstance makes it impracticable, for firms to comply with the requirements of § 101.9. In such a case, under § 101.9(g)(9), firms must submit a request in writing to FDA for the use of an alternative means of compliance or for a labeling exemption. We are proposing an alternative approach for assessing compliance of the declared amount of each of the nutrients identified previously under the circumstances we describe, given the nature of the information necessary to determine compliance and the number of foods potentially affected, because there is no suitable analytical method available to measure the quantity of each such nutrient as declared on the label or in labeling. We are proposing to require the manufacturer to make and keep records, identified in proposed § 101.9(g)(10), that are necessary to verify the declared amount of each of these nutrients on the Nutrition Facts label. In proposed § 101.9(g)(10) and (g)(11), we are proposing that manufacturers must make and keep written records, as specified for each of the nutrients and under the circumstances described in proposed § 101.9(g)(10)(i–vii), that are necessary to verify the declared amount. We tentatively conclude that the records will provide the manufacturer and FDA with the necessary means to determine compliance with § 101.9(g) requirements related to nutrient declaration. The manufacturer is in the best position to know which of its records provide the documentation required under the circumstances described previously for us to determine compliance. Some of the required records may appropriately include one or more of the following: Analyses of databases, recipes or formulations, or batch records. We recognize that the nutrient profile of processed foods that have added sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin E, or folate/folic acid can vary depending on the recipe or formulation, the suppliers of ingredients, etc. Therefore, the amount of nutrients in a food may change if a manufacturer changes ingredient suppliers or changes a recipe. PO 00000 Frm 00078 Fmt 4701 Sfmt 4702 In order to verify the nutrient composition of a packaged food, the manufacturer would need to ensure that the records it provides to us to verify the declared amount of each of these nutrients, under the circumstances described, substantiate the nutrient composition of the specific food and, as appropriate, can distinguish among the same or similar product the manufacturer has in the marketplace that may contain differing amounts of the declared nutrient. For example, the manufacturer may have to distinguish among different fruit juice products with different amounts of added sugars or the same fruit juice product with different formulations. Most manufacturers should already have the type of records needed to validate the declared amount of each of these nutrients. The records requirements provide flexibility in what records the manufacturer makes available to us to verify the declared amount of these nutrients for a particular marketed product. In the absence of an accurate and reliable analytical method for quantifying the amount of these nutrients for nutrition labeling under the circumstances described, only the manufacturer will have the information required to determine the accuracy of the declared amount. The information contained in manufacturers’ records is an accurate and practical method for assuring that the nutrient declarations comply with section 403(q) of the FD&C Act. Under section 403(q) of the FD&C Act, a food must bear, in its label or labeling, the amount of the nutrient the food contains. The purpose of providing the nutritional value of the food is to assist consumers in maintaining health dietary practices. Moreover, the nutrient declaration must be truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&C Act. Under section 701(a) of the FD&C Act, we may issue regulations for the efficient enforcement of the FD&C Act in order to ‘‘effectuate a congressional objective expressed elsewhere in the Act’’ (Association of American Physicians and Surgeons, Inc. v FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm. Mfrs. Ass’n. v FDA, 484 F. Supp. 1179, 1183 (D. Del. 1980). The proposed record requirements for these nutrients, under the circumstances described, are designed to ensure that the nutrient declarations are accurate, truthful and not misleading, based on information known only to the manufacturer, and to facilitate efficient and effective action to enforce the requirements when necessary. Our authority to establish records E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules requirements has been upheld under other provisions of the FD&C Act where we have found such records to be necessary (National Confectioners Assoc. v. Califano, 569 F.2d 690, 693– 94 (D.C. Cir. 1978). The records we propose to require are only for foods for which an AOAC or other reliable and appropriate analytical method is not available. They allow us to verify the declared amount of each of these nutrients and that such amount is truthful and not misleading. Thus, the proposed records requirements assist in the efficient enforcement of the FD&C Act. The authority granted to us under sections 701(a), 403(q), 403(a)(1) and 201(n) of the FD&C Act not only includes authority to establish records requirements, but also includes access to such records. Without such authority, the nutrient declarations for these specific nutrients that we have determined are necessary to assist consumers in maintaining healthy dietary practices under section 403(q)(2)(A) of the FD&C Act are, practically speaking, not enforceable. Without access to such records, we would not know whether the amount declared on the label or in the labeling of each of these nutrients, under the circumstances described, is truthful and not misleading under sections 403(a)(1) and 201(n). The introduction or delivery for introduction into interstate commerce of a misbranded food is a prohibited act under section 301(a) of the FD&C Act. Thus, in order for us to determine whether the food is misbranded and the manufacturer has committed a prohibited act, we must have access to the manufacturer’s records that we are requiring be kept under sections 403(q), 403(a) and 201(n) of the FD&C Act. We anticipate that manufacturers may have concerns about the confidentiality of the information inspected by us under this proposal. We would protect confidential information from disclosure, consistent with applicable statutes and regulations, including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and 21 CFR part 20. Finally, it is necessary for the aforementioned records to be made available for review and copying while the product is available for purchase in the marketplace. The shelf life of packaged foods varies by product. Due to the significant number of packaged food products in the marketplace, there could be a wide variety of shelf lives among packaged foods. Some foods are subject to specific records requirements, such as dietary supplements (§ 111.605 (21 CFR 111.605)), low acid canned VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 foods (21 CFR 113.100), acidified foods (21 CFR 114.100), fruit juice (§ 111.120), and seafood (§ 111.123). Therefore, the record retention period we propose to require to verify certain nutrient declarations may include records that manufacturers are required to make and keep for the same or longer periods under other requirements. The proposed record requirements for purposes of verifying nutrient declarations of such nutrients are separate and distinct from other record requirements. Generally, manufacturers are required to make and keep records for a minimum of 2 years (21 CFR 1.360(d)), which the Agency considers a reasonable period of time for most foods to be available for purchase in the marketplace. Thus, we are proposing to require that manufacturers must make and keep written records to verify the declaration of: (1) The amount of added sugars when both naturally occurring and added sugars are present in a food (in § 101.9(c)(6)(iii)); (2) the amount of added non-digestible carbohydrate(s) that does not meet the proposed definition of dietary fiber when the dietary fiber present in a food is a mixture of non-digestible carbohydrates that do and that do not meet the definition of dietary fiber (in § 101.9(c)(6)(i)); (3) the amount of added soluble non-digestible carbohydrate(s) that does not meet the proposed definition of dietary fiber when the soluble dietary fiber present in a food is a mixture of soluble non-digestible carbohydrates that do and that do not meet the definition of dietary fiber (in § 101.9(c)(6)(i)(A)); (4) the amount of added insoluble non-digestible carbohydrate(s) that do not meet the proposed definition of dietary fiber when the insoluble dietary fiber present in a food is a mixture of insoluble nondigestible carbohydrates that do and that do not meet the definition of dietary fiber (in § 101.9(c)(6)(i)(B)); (5) the amount of all rac-a-tocopherol acetate added to the food and RRR-atocopherol in the finished food when a mixture of both forms of vitamin E are present in a food (in § 101.9(g)(10)(i)); and (6) and the amount of folic acid added to the food and the amount of folate in the finished food when a mixture of both forms are present in a food (in § 101.9(g)(10)(ii)). We are also proposing, in § 101.9(g)(11), that such records must be kept for a period of 2 years after introduction or delivery for introduction of the food into interstate commerce. In addition, we are proposing to require that such records must be provided upon request, during an inspection, for official review and PO 00000 Frm 00079 Fmt 4701 Sfmt 4702 11957 photocopying or other means of reproduction, and that records required may be retained either as original records, true copies (such as photocopies, pictures scanned copies, microfilm, microfiche, or other accurate reproductions of the original records) or electronic records. Where reduction techniques, such as microfilming are used, suitable reader and photocopying equipment would need to be readily available. All electronic records maintained under § 101.9 would need to comply with part 11 of this chapter (§ 101.9(g)(11)). We note that Part 11 would apply to any electronic records that are maintained to comply with the proposed requirements. We advise that the use of electronic records is voluntary and thus, a paper record system could be used to comply with these proposed recordkeeping requirements. The proposed requirements for electronic records extend to electronic signatures. We issued final guidance for industry on this topic. The guidance, entitled ‘‘Part 11, Electronic Records; Electronic Signatures Scope and Application,’’ sets out the Agency’s enforcement policies with respect to certain aspects of part 11. The guidance is available at https:// www.fda.gov/RegulatoryInformation/ Guidances/ucm125067.htm. This guidance would apply to any electronic record, including electronic signatures, established or maintained to meet a proposed requirement in this rule, if finalized as proposed. We request comment on the proposed requirements for the types of records that must be made and kept and the length of time that the records must be kept. 4. Inclusion of Potassium as a Mineral Potassium is specified as a Class I and Class II nutrient in § 101.9(g)(4)(i) and (g)(4)(ii), respectively. This nutrient is the only vitamin or mineral that is specifically listed under the description of both Class I and Class II nutrients. Potassium is a mineral for which an RDI is being proposed (§ 101.9(c)(8)(iv)) and the absolute amount would be required to be declared along with a percent DV on the Nutrition Facts label. We tentatively conclude that there is no need to separately list potassium under the description of Class I and Class II nutrients because it is encompassed within the category, mineral. Therefore, we are proposing to remove specific inclusion of the term ‘‘potassium’’ within § 101.9(g)(4), (g)(4)(i), (g)(4)(ii), and (g)(6) such that it would be covered under ‘‘mineral’’ and any listing of potassium on the Nutrition Facts label would have to meet the specific compliance requirements for minerals E:\FR\FM\03MRP2.SGM 03MRP2 11958 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 under § 101.9(g)(4), (g)(4)(i), (g)(4)(ii), and (g)(6). 5. Requirements for Other Carbohydrate, Soluble and Insoluble Fiber, Added Sugars, and Sugar Alcohols The labeling requirements for Class I and Class II nutrients are provided in section § 101.9(g)(4). For the reasons discussed in section II.D.6., we are proposing to revise § 101.9(c)(6)(iv) to remove the provision for voluntary declaration of ‘‘Other carbohydrate.’’ Accordingly, we are proposing to remove compliance requirements related to ‘‘Other carbohydrate’’ in § 101.9(g)(4) and (g)(6). Dietary fiber is included as both a Class I and Class II nutrient because food products may contain only nondigestible carbohydrates that meet the definition of dietary fiber and that may be naturally occurring or that may be added to fortified or fabricated foods. The same is true for soluble and insoluble fiber, yet these nutrients are not specifically listed as Class I or Class II nutrients. Therefore, we are proposing to include soluble and insoluble fiber in § 101.9(g)(4) as both Class I and Class II nutrients. Section § 101.9(g)(5) specifies that a food with a label declaration of calories, sugars, total fat, saturated fat, trans fat, cholesterol or sodium shall be deemed to be misbranded under section 403(a) of the FD&C Act if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label. The nutrients listed in this section can have a negative impact on health in the general U.S. population if consumed in excess and/or there are current dietary recommendations to reduce the consumption of these nutrients. Therefore, we are ensuring in § 101.9(g)(5) that foods do not contain excessive amounts of these nutrients of which the consumer is not aware. Current dietary recommendations acknowledge that Americans consume excess amounts of added sugars and encourage reducing intake of calories from added sugars. As discussed in section II.D.3., added sugars, like naturally occurring sugars, can contribute to dental caries. As with the other nutrients listed in § 101.9(g)(5), we have an interest in ensuring that foods do not contain excessive amounts of added sugars that are not declared on the label. Therefore, we are proposing to include added sugars in § 101.9(g)(5). In some food products, the only source of sugars may be added sugars. In such cases, an analytical method could be used to determine the amount of added sugars in the food product and the VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 permitted analytical variability would be applicable. Accordingly, we are proposing to amend § 101.9(g)(5) to include ‘‘added sugars (when the only source of sugars in the food is added sugars)’’ among the list of nutrients. In § 101.9(g)(6), reasonable excesses of certain nutrients over labeled amounts are acceptable within current good manufacturing practice. In addition, reasonable deficiencies of certain other nutrients under labeled amounts are acceptable within current good manufacturing practice. Consistent with this approach, we are proposing to allow, in § 101.9(g)(6), reasonable excesses over the labeled amount of soluble and insoluble fiber and sugar alcohols when they are acceptable within current good manufacturing practice, and reasonable deficiencies under labeled amounts of added sugars when they are acceptable within current good manufacturing practice. As with other nutrients added to fortified or fabricated foods, we expect that when a food product contains added sugars, when all of the dietary fiber (both soluble and insoluble) is added nondigestible carbohydrate that meets the definition of dietary fiber, when all of the vitamin E is all rac-a-tocopherol acetate, and when only folic acid is present in a food, the declared amount must be a least equal to the amount of the nutrient added to the food. In summary, we are proposing the following changes related to compliance: (1) Amend § 101.9(g)(2) to cite the 19th edition of the Official Methods of Analysis of the AOAC International as the reference for appropriate methods used to determine compliance with amounts of nutrients declared on the Nutrition Facts label; (2) amend § 101.9(c)(6)(i), (c)(6)(iii), (g)(10), (g)(10)(i), and (g)(10)(ii) to establish general recordkeeping requirements when records are necessary to verify information related to dietary fiber, added sugars, folate, and vitamin E provided on the label; (3) remove specific inclusion of the term ‘‘potassium’’ within § 101.9(g)(4), (g)(4)(i), (g)(4)(ii), and (g)(6) such that potassium would covered under ‘‘mineral’’ and any listing of potassium on the Nutrition Facts label would meet the specific compliance requirements for minerals under § 101.9(g)(4), (g)(4)(i), (g)(4)(ii), and (g)(6); (4) when all of dietary fiber in a food product meets the proposed definition of dietary fiber, include soluble and insoluble fiber as both Class I and Class II nutrients under § 101.9(g)(4); (5) include added sugars within § 101.9(g)(5) such that the label declaration of added sugars will be deemed misbranded under section PO 00000 Frm 00080 Fmt 4701 Sfmt 4702 403(a) of the FD&C Act if the nutrient composite is greater than 20 percent in excess of the added sugars value declared on the label, and within § 101.9(g)(6) such that reasonable deficiencies of added sugars would be permitted; (6) include soluble and insoluble fiber and sugar alcohols within § 101.9(g)(6) such that reasonable excesses of these nutrients would be permitted; and (7) consistent with the tentative conclusion in section II.D.6., remove references to ‘‘Other carbohydrates’’ in § 101.9(g). O. Technical Amendments 1. Changing the Name of the Program Office Since publication of the regulations for nutrition labeling, the name of the office at the Center for Food Safety and Applied Nutrition that is responsible for developing regulations and answering questions related to nutrition labeling as well as for maintaining some of the references discussed throughout § 101.9 has changed. The Office of Nutritional Products, Labeling and Dietary Supplements is now called the Office of Nutrition, Labeling and Dietary Supplements. We are proposing to update the name of the office throughout § 101.9. 2. Changing the Publication Date of Report Incorporated by Reference Section § 101.9(c)(7)(ii) provides that the protein digestibility-corrected amino acid score ‘‘shall be determined by methods given in sections 5.4.1, 7.2.1, and 8.00 in ‘‘Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,’’ Rome, 1990, except that when official AOAC procedures described in section (c)(7) of this paragraph require a specific food factor other than 6.25, that specific factor shall be used.’’ We incorporated the ‘‘Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation’’ by reference in § 101.9(c)(7)(ii). Although the referenced report was written in 1989, it was published in 1991. We are, therefore, proposing to change the publication date of the report that is incorporated by reference from 1990 to 1991. 3. Plain Language Edits On October 13, 2010, the President signed the Plain Writing Act of 2010 requiring that Federal Agencies use ‘‘clear Government communication that the public can understand and use.’’ On January 18, 2011, the President issued an Executive Order (E.O. 13563 (75 FR 3821)—Improving Regulation and E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Regulatory Review) that requires that the government must ensure that regulations are accessible, consistent, written in plain language, and easy to understand. In an effort to make the requirements of § 101.9 easier to understand, we are proposing to make editorial changes that do not change the meaning or intent of the language in § 101.9(g)(3)(ii); (g)(4)(i); (g)(4)(ii); and (g)(5). In § 101.9(g)(3)(ii), we are revising the current language to clarify that when a nutrient or nutrients are not naturally occurring (exogenous) in an ingredient that is added to a food, the total amount of such nutrient(s) in the final food product is subject to Class I requirements rather than Class II requirements. It is not explicitly stated in the current regulation that such a nutrient would be subject to Class I requirements. In § 101.9(g)(4)(i) and (g)(4)(ii), the definitions include a list of vitamins and minerals that are being defined as Class I or Class II vitamins and minerals followed by compliance requirements for those nutrients. This differs from the definition provided in § 101.9(g)(3)(i) and (g)(3)(ii) in that the definitions provided in § 101.9(g)(3)(i) and (g)(3)(ii) are about whether a nutrient is added or naturally occurring. We are proposing to remove ‘‘Class I’’ and ‘‘Class II’’ from the beginning of sections § 101.9(g)(4)(i) and (g)(4)(ii) and to state instead that when the list of nutrients provided in those sections meets the definition of a Class I or Class II nutrient provided for in § 101.9(g)(3)(i) and (g)(3)(ii), the declaration of those nutrients must meet certain requirements. The proposed change is being made to prevent confusion by having two different definitions of a ‘‘Class I’’ and ‘‘Class II’’ nutrient for compliance with nutrition labeling requirements. In § 101.9(g)(5), we are proposing to remove the words ‘‘Provided, That’’. These words do not provide further clarification and they add additional complexity to the section that is not necessary. III. Proposed Effective and Compliance Dates We intend that any final rule resulting from this rulemaking, as well as any final rule resulting from the proposed rule entitled ‘‘Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments’’ become effective 60 days after the date VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 of the final rule’s publication in the Federal Register with a compliance date 2 years after the effective date. We recognize that it may take industry time to analyze products for which there may be new mandatory nutrient declarations, make any required changes to the Nutrition Facts label (which may be coordinated with other planned label changes), review and update their records of product labels, and print new labels. A compliance date that is 2 years after the effective date is intended to provide industry time to revise labeling to come into compliance with the new labeling requirements while balancing the need for consumers to have the information in a timely manner. We invite comment on the proposed compliance date. IV. Analysis of Impacts We have examined the impacts of this proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601–612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4) and the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We are publishing two proposed rules on nutrition labeling in the Federal Register. We have developed one comprehensive Preliminary Regulatory Impact Analysis (PRIA) (Ref. 187) that presents the benefits and costs of the two proposed nutrition labeling rules taken together; the PRIA is available at https://www.regulations.gov (Docket No. FDA–2012–N–1210). The full economic impact analyses of FDA regulations are no longer (as of April 2012) published in the Federal Register but are submitted to the docket and are available on this site. We believe that the cumulative impact of the proposed rules on nutrition labeling, taken as a whole, represent a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Additional costs per entity of the proposed rule are small, but not negligible, and as a result we conclude that the proposed rules on nutrition labeling, taken as a whole, would have PO 00000 Frm 00081 Fmt 4701 Sfmt 4702 11959 a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that we prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ‘‘any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.’’ The current threshold after adjustment for inflation is $141 million, using the most current (2012) Implicit Price Deflator for the Gross Domestic Product. We have determined that the proposed rules on nutrition labeling, taken as a whole, meet this threshold. The analysis that we have performed to examine the impacts of the proposed rules under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the PRA (see section V.) are included in the PRIA (Ref. 187) and are available at https:// www.regulations.gov (Docket No. FDA– 2012–N–1210). We invite comment on the PRIA. V. Paperwork Reduction Act of 1995 This proposed rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the PRA. A description of these provisions is given in the PRIA (Ref. 187) available at https:// www.regulations.gov (Docket No. FDA– 2012–N–1210) with an estimate of the annual reporting, recordkeeping, and third-party disclosure burden. Included in the burden estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. We invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. To ensure that comments on information collection are received, E:\FR\FM\03MRP2.SGM 03MRP2 11960 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the title ‘‘Record Retention, Reporting, and Third-Party Disclosure Requirements for the Declaration of Added Sugars, Dietary Fiber, Soluble Fiber, Insoluble Fiber, Vitamin E, and Folate/Folic Acid.’’ In compliance with the PRA, we have submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until we obtain OMB approval. We will publish a notice concerning OMB approval of these requirements in the Federal Register. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 VI. Analysis of Environmental Impact We have carefully considered the potential environmental effects of this action. We have concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required (Refs. 188 and 189). Our finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. VII. Federalism We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive Order requires Agencies to ‘‘construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.’’ Section 403A of the FD&C Act (21 U.S.C. 343–1) is an express preemption provision. Section 403A(a) of the FD&C Act provides that: ‘‘* * * no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce—(4) any requirement for nutrition labeling of food that is not identical to the requirement of section 403(q) * * *.’’ The express preemption provision of section 403A(a) of the FD&C Act does not preempt any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 food or component of the food (section 6(c)(2) of the Nutrition Labeling and Education Act of 1990, Pub. L. 101–535, 104 Stat. 2353, 2364 (1990)). If this proposed rule is made final, the final rule would create requirements that fall within the scope of section 403A(a) of the FD&C Act. VIII. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. We invite comment on all aspects of the proposed rule, including the need for, and appropriateness of, the various provisions proposed in this rule and our accompanying rationale. Specifically: (1) We invite comment on our use of the most recent consensus reports and whether the information and data on which FDA relies from such reports for proposed changes is consistent with current scientific information, the factors for considering mandatory and voluntary declaration of non-statutory nutrients, and whether there is an appropriate alternative analysis to application of these factors regarding (a) no longer permitting mandatory declaration (i.e., vitamins A and C); (b) requiring the declaration of a nutrient that is currently voluntary (e.g., vitamin D), and; (c) continuing the voluntary labeling of macronutrients (e.g., monounsaturated and polyunsaturated fats); (2) We invite comment on the tentative conclusion to no longer permit the declaration of ‘‘Calories from fat’’ on the Nutrition Facts label and on the tentative conclusion not to establish a DRV for calories and include a percent DV for the declaration of calories, which are discussed in section II.A; (3) In section II.B., we addressed various issues related to the declaration of total fat and related nutrients. We invite comment on the proposed definition of fatty acids, as well as on our tentative conclusion that acetic, propionic, and butyric acids should not be excluded from the definition of total fat; (4) We invite comment on various issues related to the declaration of carbohydrates and related nutrients, which are discussed in section II.D.: (a) PO 00000 Frm 00082 Fmt 4701 Sfmt 4702 With respect to added sugars, we request comments on our tentative conclusions and proposed provisions for mandatory declaration of added sugars, the placement of this information as double indented line below total sugars, and means to verify compliance. We also invite comment, including the submission of available research, on whether calories from added sugars should be declared on the Nutrition Facts label in lieu of a gram declaration of added sugars to aid consumers in maintaining healthy dietary practices. We also invite comment on products that are subjected to non-enzymatic browning reactions and fermentation, and the amount of variability that occurs among various types of products where added sugars are transformed into other compounds as a result of chemical reactions during food processing; (b) with respect to dietary fiber, we invite comment on the proposed definition of dietary fiber and retaining the term ‘‘dietary fiber.’’ We invite comment, including the submission of information on consumer understanding of the term ‘‘dietary fiber’’ relative to other relevant terms; and (c) we are proposing to eliminate the provision for voluntary declaration of ‘‘Other carbohydrate’’ on the Nutrition Facts label, and tentatively conclude that the proposed amendment is unlikely to have a significant impact on industry or consumers. We invite comment on this issue, including the submission of any other data or factual information that we should consider in making a final determination. (5) We invite comment on our tentative conclusions related to sodium discussed in section II.G., including the proposed DRV. In particular, we invite comment on: (a) The rationale for the proposed DRV of 2,300 for sodium; (b) whether a RDI of 1,500j mg would be more appropriate and why, and; (c) alternative approaches for selecting a DV for sodium and their public health basis for these approaches. We are also interested in comment, including data and factual information on consumer understanding, interpretation, and use of the percent DV of sodium declared on food labels, and the understanding and potential influences of a DV that reflects an RDI based on an AI (an intake level to not consume less of), instead of a DRV based on a UL (an intake level not to exceed); (6) In section II.H., we are proposing to: (a) Retain mandatory declaration of calcium and iron; (b) provide for voluntary declaration of vitamins A and C; (c) require the declaration of potassium and vitamin D; and (d) retain voluntary declaration of several other E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules vitamins and minerals. We are also proposing to require that all vitamins and minerals declared on the Nutrition Facts label must include their quantitative amounts (in addition to the requirements for corresponding percent DV declaration). We invite comment on these tentative conclusions, including the appropriate placement of the quantitative amounts of nutrients on the Nutrition Facts label, including data and other available information on the impact of mandatory labeling of vitamins and minerals on food fortification. We invite comment on the proposed mandatory declaration of vitamin D, potassium, calcium and iron on the label, including how we consider the public health significance of each. We also invite comment on whether the presence of these nutrients presents concerns related to label space or the need for consumer education. We also invite comment on whether the presence of these nutrients presents concerns related to label space or the need for consumer education. (7) In section II.I., we are proposing to use population-coverage RDAs, when available, or AIs as the basis for establishing RDIs. We invite comment on our analysis and rationale, including available data and information related to our analysis, and any available data on what role, if any, the basis of the DV (EAR or RDA) has on consumption of nutrients above the UL and in discretionary fortification of foods; we request comment on lowering the RDI of B12 to 2.4 mg. (8) In section II.I.6, whether quantitative amounts for nutrients with RDI values that contain three or four digits should be rounded, what the rounding increments should be, and data to support suggested rounding increments for such vitamins and minerals. (9) We invite comment on issues related to units of measure, nomenclature, and analytical methods, which are discussed in section II.J.; (10) We invite comment on issues related to nutrition labeling for foods represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women, which are addressed in section II.K., including (a) any available relevant empirical research as to whether the proposed declaration of saturated fat and cholesterol for infants and children 1 through 3 years of age is likely to be confusing to consumers or otherwise result in restriction of fat intakes among these subpopulations; (b) how consumers would understand and use the information on amounts of VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 saturated fat and cholesterol in the nutrition labeling of foods for infants and young children and whether there is a need for an explanatory footnote to accompany such proposed mandatory declaration; (c) our tentative conclusion that declaration of added sugars should be mandatory on foods represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women; and (d) adequacy of the proposed RDIs for vitamins and minerals for older infants and children 1 through 3 years of age. (11) We invite comment, including available data and other information on the reformulation of dietary supplement products that may result from proposed changes to the DVs, as well as information on the potential consequences of such reformulations; (12) We invite comment on whether we should consider changes to the footnote statement ‘‘Percent Daily Values are based on a 2,000 calorie diet’’ used on dietary supplement labels to be consistent with any changes to the footnote statement in the Nutrition Facts label. (13) We invite comment on (a) including the use of an alternative format design or requiring the use of a specific font; (b) our tentative conclusion that emphasizing both the number of calories per serving and the number of servings per container will serve as an anchor to highlight this information and grab the reader’s attention, and therefore will assist consumers to effectively use this information in the Nutrition Facts label; (c) whether any of the changes that are being proposed to the Nutrition Facts label should also be required for certain products with Supplement Facts labels that list calories and/or other macronutrients, and if so, under what conditions and for which dietary supplement products should such labeling be required; (d) our tentative view that there is no need to propose changing the order of how serving size and servings per container are listed on the Supplement Facts label, or to make amendments in the type size or capitalization corresponding to our proposed changes for this information on the Nutrition Facts labels; (e) our tentative conclusion that, based on design considerations, the label statement for ‘‘Serving size’’ in both household units and gram amounts should be right-justified on the same line that ‘‘Serving size’’ is listed; (f) our tentative conclusion that changing the ‘‘Amount Per Serving’’ statement to ‘‘Amount per___’’ with the blank filled in with the actual serving size would PO 00000 Frm 00083 Fmt 4701 Sfmt 4702 11961 assist consumers in using the information and may lessen the time and effort needed to locate the target information and improve the accuracy of judgments about the calorie amounts and nutrient contents of packaged food products; (g) the double indented placement of added sugars below total sugars and invite available research data formation; (h) our tentative view that increasing the type size, bolding key elements of the footnote (space permitting), and adding a bar clearly separating it from the micronutrient information directly above will assist consumers in using the information; (i) our tentative view on the need for a footnote statement for enhancing consumers’ use and understanding of the percent DV; (j) using data provided consumer research we plan to conduct during this rulemaking that will test consumer reactions to a definition of percent DV, a succinct statement on calories, and several statements related to the ‘‘5/20 rule’’; (k) whether or not this calorie conversion information should continue to be optional on the Nutrition Facts label, and whether there are any data suggesting that consumers do or do not use this information; (l) alternative terms that may be more readily understandable than Daily Value, such as Daily Guide or Daily Need; (m) whether the word ‘‘percent’’ (or the % symbol) needs to precede whatever term is used in the column heading where the percent DVs are listed; (n) whether there is a need to include vertical lines that are similarly placed on Supplement Facts labels for multiple vitamins in packets (§ 101.36(e)(11)(iii)) and for dietary supplements that list ‘‘per serving’’ and ‘‘per day’’ information (§ 101.36(e)(11)(viii)); (o) the appropriate placement of percent DVs in the labeling of foods for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women; (p) our tentative conclusion to insert a 0.25 point hairline rule directly beneath the Nutrition Fact heading on all label formats, with the exception of the linear display for small packages; (q) listing the total carbohydrate content in a serving as ‘‘Total Carbs’’ instead of ‘‘Total Carbohydrate’’ or ‘‘Total Carb’’ and its listing used on all label formats; (r) an alternative concept for the Nutrition Facts label format that indicates ‘‘quick facts’’ about a product’s nutrient content and explicitly points out nutrients to ‘‘avoid too much’’ of as well as nutrients to ‘‘get enough’’ of, and; (s) whether a specific font should be required for the Nutrition E:\FR\FM\03MRP2.SGM 03MRP2 11962 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules Facts label. We request comment on how this display may or may not convey the information in a manner which enables the public to readily observe and comprehend such information and whether separating and placing nutrients such as ‘‘Total Fat’’ and ‘‘Saturated Fat’’ under different headings would help or hinder consumer’s understanding of the Nutrition Facts label. We also are interested in comments on what headings could be used and how to categorize all of the nutrients. IX. References mstockstill on DSK4VPTVN1PROD with PROPOSALS2 The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at https:// www.regulations.gov. (FDA has verified all the Web site addresses in this reference section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. U.S. Food and Drug Administration. ‘‘Memorandum to the File: Regulatory History Related to Nutrition Labeling for Proposed Rule ‘‘Food Labeling: Revision of the Nutrition and Supplement Facts Label’’, 2014. 2. Centers for Disease Control and Prevention. (August 13, 2012) ‘‘Chronic Diseases and Health Promotion’’. Retrieved from https://www.cdc.gov/ chronicdisease/overview/index.htm. 3. Lloyd-Jones, D., Adams, R.J., Brown, T.M., et al. ‘‘Heart Disease and Stroke Statistics—2010 Update: A Report From the American Heart Association’’. Circulation. 2010;121:e46–e215. 4. Centers for Disease Control and Prevention. (2011) ‘‘National Diabetes Fact Sheet, 2011’’. Retrieved from https:// www.cdc.gov/diabetes/pubs/pdf/ ndfs_2011.pdf. 5. National Cancer Institute. (2011) ‘‘Surveillance Epidemiology and End Results (SEER) Stat Fact Sheets: All Sites’’. Retrieved from https:// seer.cancer.gov/statfacts/html/all.html. 6. U.S. Department of Agriculture and U.S. Department of Health and Human Services. (2010) ‘‘Dietary Guidelines for Americans, 2010’’, 7th Ed., Washington DC: U.S. Government Printing Office. Retrieved from https:// www.cnpp.usda.gov/DGAs2010PolicyDocument.htm. 7. Flegal, K.M., Carroll, M.D., Ogden, C.L., et al. ‘‘Prevalence and Trends in Obesity Among U.S. Adults, 1999–2008’’. JAMA: the Journal of the American Medical Association. 2010;303:235–241. 8. Ogden, C.L., Carroll, M.D., Curtin, L.R., et al. ‘‘Prevalence of High Body Mass Index in U.S. Children and Adolescents, 2007– 2008’’. JAMA: the Journal of the VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 American Medical Association. 2010;303:242–249. 9. National Institutes of Health, National Heart Lung and Blood Institute in cooperation with The National Institute of Diabetes and Digestive and Kidney Diseases. (1998) ‘‘Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report; NIH Publication No. 98–4083’’. Retrieved from https://www.nhlbi.nih.gov/ guidelines/obesity/ob_gdlns.pdf. 10. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate, Chapter 6: Sodium and Chloride’’, Washington, DC: National Academies Press; 2005. pp. 269–423. 11. U.S. Food and Drug Administration. ‘‘Memorandum to the File: Total Usual Intakes of Sodium for 4 Years and Older’’, 2014. 12. Usual Sodium Intakes Compared With Current Dietary Guidelines—United States, 2005–2008. MMWR Morbidity and Mortality Weekly Report. 2011;60:1413–1417. 13. Institute of Medicine (IOM) of the National Academies. ‘‘The Development of the DRIs, 1994–2004: Lessons Learned and New Challenges, Workshop Summary’’, Washington, DC: National Academies Press; 2008. 14. Institute of Medicine (IOM) of the National Academies. ‘‘How Should the Recommended Dietary Allowances Be Revised’’, Washington, DC: National Academies Press; 1994. 15. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes: The Essential Guide to Nutrient Requirements’’, Washington DC: National Academies Press; 2006. 16. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride’’, Washington, DC: National Academies Press; 1997. 17. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline’’, Washington, DC: National Academy Press; 1998. 18. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids’’, Washington, DC: National Academies Press; 2000. 19. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc’’, Washington, DC: National Academies Press; 2001. 20. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, PO 00000 Frm 00084 Fmt 4701 Sfmt 4702 and Amino Acids (Macronutrients), Summary’’, Washington, DC: National Academies Press; 2002. pp. 1–19. 21. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate’’, Washington, DC: National Academies Press; 2005. 22. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Calcium and Vitamin D’’, Washington, DC: National Academies Press; 2011. 23. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients)’’, Washington, DC: National Academies Press; 2002. 24. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes: Proposed Definition of Dietary Fiber’’, Washington DC: National Academies Press; 2001. 25. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification’’, Washington, DC: National Academies Press; 2003. 26. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes: Applications in Dietary Planning’’, Washington, DC: National Academies Press; 2003. 27. Institute of Medicine (IOM) of the National Academies. ‘‘Strategies to Reduce Sodium Intake in the United States’’, Washington, DC: National Academies Press; 2010. 28. Institute of Medicine (IOM) of the National Academies. ‘‘Examination of Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report’’, Washington, DC: National Academies Press; 2010. 29. Institute of Medicine (IOM) of the National Academies. ‘‘Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices’’, Washington, DC: National Academies Press; 2012. 30. U.S. Department of Agriculture and U.S. Department of Health and Human Services. (2010) ‘‘Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010’’, Washington, DC: U.S. Government Printing Office. Retrieved from https:// www.cnpp.usda.gov/DGAs2010– DGACReport.htm. 31. U.S. Department of Agriculture and U.S. Department of Health and Human Services. (1980) ‘‘Nutrition and Your Health, Dietary Guidelines for Americans, 1980’’, Home and Gardening Bulletin No. 232, 1st Ed., Washington, DC: U.S. Government Printing Office. Retrieved from https://www.health.gov/ dietaryguidelines/1980thin.pdf. 32. U.S. Department of Agriculture and U.S. Department of Health and Human Services. (1985) ‘‘Nutrition and Your Health, Dietary Guidelines for Americans, 1985’’, Home and Gardening Bulletin No. 232, 2nd Ed., Washington, E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules DC: U.S. Government Printing Office. Retrieved from https://www.health.gov/ dietaryguidelines/1985thin.pdf. 33. U.S. Department of Agriculture and U.S. Department of Health and Human Services. (1990) ‘‘Nutrition and Your Health, Dietary Guidelines for Americans, 1990’’, Home and Gardening Bulletin No. 232, 3rd Ed., Washington, DC: U.S. Government Printing Office. Retrieved from https://www.health.gov/ DietaryGuidelines/1990thin.pdf. 34. U.S. Department of Agriculture and U.S. Department of Health and Human Services. (1995) ‘‘Nutrition and Your Health, Dietary Guidelines for Americans, 1995’’, Home and Gardening Bulletin No. 232, 4th Ed., Washington, DC: U.S. Government Printing Office. Retrieved from https://www.cnpp.usda. gov/Publications/DietaryGuidelines/ 1995/1995DGConsumerBrochure.pdf. 35. U.S. Department of Agriculture and U.S. Department of Health and Human Services. (November 30, 2012) ‘‘Nutrition and Your Health, Dietary Guidelines for Americans, 2000’’, Home and Gardening Bulletin No. 232, 5th Ed., Washington, DC: U.S. Government Printing Office. Retrieved from https:// www.health.gov/dietaryguidelines/ dga2000/dietgd.pdf. 36. U.S. Department of Health and Human Services and U.S. Department of Agriculture. (2005) ‘‘Dietary Guidelines for Americans, 2005’’. 6th Edition, Washington, DC: U.S. Government Printing Office. Retrieved from https:// www.health.gov/dietaryguidelines/ dga2005/document/pdf/DGA2005.pdf. 37. Centers for Disease Control and Prevention. (September 12, 2012) ‘‘About the National Health and Nutrition Examination Survey’’. Retrieved from https://www.cdc.gov/nchs/nhanes/about_ nhanes.htm. 38. Derby, B., Levy, A. ‘‘Do Food Labels Work?’’. In: Handbook of Marketing and Society. Thousand Oaks, CA: Sage; 2000. 39. U.S. Food and Drug Administration. (2007) ‘‘2002 Health and Diet Survey: Topline Frequency Report’’. Retrieved from https://www.fda.gov/food/food scienceresearch/consumerbehavior research/ucm202786.htm. 40. U.S. Food and Drug Administration. (2008) ‘‘Health and Diet Survey: Dietary Guidelines Supplement- Report Findings (2004 & 2005)’’. Retrieved from https:// www.fda.gov/downloads/Food/Science Research/ResearchAreas/Consumer Research/UCM080413.pdf. 41. U.S. Food and Drug Administration. (January 1, 2010) ‘‘2008 Health and Diet Survey: Topline Frequencies’’. Retrieved from https://www.fda.gov/food/food scienceresearch/consumerbehavior research/ucm193895.htm. 42. Todd, J. E. ‘‘Changes in Eating Patterns and Diet Quality Among Working-Age Adults, 2005–10, EER–161’’, Washington, DC: U.S. Department of Agriculture, Economic Research Service; 2014. 43. Levy, L., Patterson, R.E., Kristal, A.R., et al. ‘‘How Well Do Consumers VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Understand Percentage Daily Value on Food Labels?’’. American Journal of Health Promotion: AJHP. 2000;14:157– 160. 44. Lando, A.M., Labiner-Wolfe, J. ‘‘Helping Consumers Make More Healthful Food Choices: Consumer Views on Modifying Food Labels and Providing Point-ofPurchase Nutrition Information at QuickService Restaurants’’. Journal of Nutrition Education and Behavior. 2007;39:157–163. 45. International Food Information Council Foundation. (2010) ‘‘Food Label Consumer Research Project’’. Retrieved from https://www.foodinsight.org/ Content/3145/FINAL%20IFIC%20 Foundation%20Food%20Label%20 Consumer%20Research%20-%20Phase %20III%20Summary%20Report.pdf. 46. U.S. Food and Drug Administration. (April 27, 2004) ‘‘Meeting Minutes From the Nutrition Subcommittee of the Food Advisory Committee Meeting on Total Fat and Trans Fat’’. Retrieved from https://www.fda.gov/ohrms/dockets/ac/ 04/minutes/4035m1_FinalSummary Minutes.htm. 47. U.S. Food and Drug Administration. ‘‘Memorandum to the File: Comments Considered in the Development of the Revision of the Nutrition and Supplements Facts Proposed Rule’’, 2014. 48. U.S. Food and Drug Administration. ‘‘Memorandum to the File: Evaluation Process of the Public Health Significance of Essential Vitamins and Minerals’’, 2014. 49. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 8: Dietary Fats: Total Fat and Fatty Acids’’, Washington, DC: National Academies Press; 2002. 50. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 5: Energy’’, Washington, DC: National Academies Press; 2002. 51. Daintith, J., Martin, E. ‘‘Dictionary of Science, 6th Ed.’’. Oxford University Press; 2010; pp. 314–315. 52. Lewis, R.J., Sr., editor. Hawley’s Condensed Chemical Dictionary. 15th Ed. John Wiley & Sons, 2007; pp. 549– 550. 53. deMan, J.M. ‘‘Principles of Food Chemistry, 3rd Ed.’’. Springer-Verlag; 1999; pp. 33–70. 54. Klein S., Cohn S., Alpers D.H. ‘‘Alimentary Tract and Nutrition’’. In: Modern Nutrition In Health and Disease 10th Ed. Shils M.E., Shike M., Ross A.C., Caballero B., Cousins R.J., eds. Baltimore, MD: Lippincott Williams & Wilkins; 2006; pp. 1133–1135. 55. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report. Circulation. 2002;106:3143–3421. PO 00000 Frm 00085 Fmt 4701 Sfmt 4702 11963 56. Hornick, B.A., Krester, A.J., Nicklas, T.A. ‘‘Menu Modeling with MyPyramid Food Patterns: Incremental Dietary Changes Lead to Dramatic Improvements in Diet Quality of Menus’’. Journal of the American Dietetic Association. 2008;108:2077–2083. 57. U.S. Food and Drug Administration. (November 28, 2012) ‘‘Health Claim Notification for Saturated Fat, Cholesterol, and Trans Fat, and Reduced Risk of Heart Disease’’. Retrieved from https://www.fda.gov/food/ingredient spackaginglabeling/labelingnutrition/ ucm073621.htm. 58. Doell, D., Folmer, D., Lee, H., et al. ‘‘Updated Estimate of Trans Fat Intake by the US Population’’. Food Additives & Contaminants Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment. 2012;29:861–874. 59. U.S. Food and Drug Administration. (2004) ‘‘Letter Responding to Health Claim Petition dated November 3, 2003 (Martek Petition): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease’’, (Docket No. 2003Q–0401). Retrieved from https://www.fda.gov/food/ ingredientspackaginglabeling/labeling nutrition/ucm072932.htm. 60. Yokoyama, M., Origasa, H., Matsuzaki, M., et al. ‘‘Effects of Eicosapentaenoic Acid on Major Coronary Events in Hypercholesterolaemic Patients (JELIS): A Randomised Open-Label, Blinded Endpoint Analysis’’. The Lancet. 2007;369:1090–1098. 61. U.S. Food and Drug Administration. (2004) ‘‘Letter Responding to Health Claim Petition dated August 28, 2003: Monounsaturated Fatty Acids from Olive Oil and Coronary Heart Disease’’, (Docket No. 2003Q–0559). Retrieved from https://www.fda.gov/food/ ingredientspackaginglabeling/labeling nutrition/ucm072963.htm. 62. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 9: Cholesterol’’, Washington, DC: National Academies Press; 2002. 63. Merrill, A. L., Watt, B. K. ‘‘ ‘‘Energy Value of Foods. Basis and Derivation’’, Human Nutrition Research Branch, Agricultural Research Service, U.S. Department of Agriculture, Agriculture Handbook No. 74’’, 1973. 64. Higson S. Analytical Chemistry. 1st Ed. Oxford, NY: Oxford University Press, 2004;pp. 19–27. 65. U.S. Department of Agriculture, Agricultural Research Service USDA Nutrient Data Laboratory. (2010) ‘‘Composition of Foods Raw, Processed, Prepared, USDA National Nutrient Database for Standard Reference, Release 23’’. Retrieved from https://www.ars.usda.gov/SP2UserFiles/ Place/12354500/Data/SR23/sr23_ doc.pdf. 66. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11964 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules and Amino Acids (Macronutrients), Chapter 7: Dietary, Functional, and Total Fiber’’, Washington, DC: National Academies Press; 2002. 67. Codex Alimentarius. (2010) Guidelines on Nutrition Labeling. Retrieved from www.codexalimentarius.net/download/ standards/34/CXG_002e.pdf. 68. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 6: Dietary Carbohydrates: Sugars and Starches’’, Washington, DC: National Academies Press; 2002. 69. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 11: Macronutrients and Healthful Diets’’, Washington, DC: National Academies Press; 2002. pp. 769–879. 70. Putnam, J. J. and Allshouse J.E. (1999) ‘‘Food Consumption, Prices, and Expenditures, 1970–97’’. Food and Rural Economics Division, Economic Research Service, U.S. Department of Agriculture. Statistical Bulletin No. 965. Retrieved from https://www.ers.usda.gov/ publications/sb965/. 71. Gidding, S.S., Dennison, B.A., Birch, L.L., et al. ‘‘Dietary Recommendations for Children and Adolescents: A Guide for Practitioners: Consensus Statement From the American Heart Association’’. Circulation. 2005;112:2061–2075. 72. Johnson, R.K., Appel, L.J., Brands, M., et al. ‘‘Dietary Sugars Intake and Cardiovascular Health: A Scientific Statement From the American Heart Association’’. Circulation. 2009;120:1011–1020. 73. World Health Organization. ‘‘Diet, Nutrition, and the Prevention of Chronic Diseases. Report of a WHO Study Group’’, Geneva: World Health Organization; 1990. pp. 1–204. 74. U.S. Food and Drug Administration. (January 1, 2009) ‘‘Guidance for Industry: Evidence-Based Review System for Scientific Evaluation of Health Claims— Final’’. Retrieved from https:// www.fda.gov/food/guidanceregulation/ guidancedocumentsregulatory information/labelingnutrition/ ucm073332.htm. 75. Center for Science in the Public Interest. (2010) ‘‘Food Labeling Chaos: The Case for Reform’’. Retrieved from https:// cspinet.org/new/pdf/food_labeling_ chaos_report.pdf. 76. Center for Nutrition Policy and Promotion, U.S. Department of Agriculture Home and Garden Bulletin No. 252. (1992) ‘‘The Food Guide Pyramid’’. Retrieved from https:// www.cnpp.usda.gov/Publications/ MyPyramid/OriginalFoodGuide Pyramids/FGP/FGPPamphlet.pdf. 77. Skibsted, L.H., Risbo, J., Andersen, M.L. ‘‘Chemical Deterioration and Physical Instability of Food and Beverages’’. Woodhead Publishing; 2010; pp.70–94. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 78. U.S. Food and Drug Administration. ‘‘Memorandum to the File: Effects of Maillard Reaction, Caramelization, and Fermentation on Added Sugar Content of Foods’’, 2014. 79. Murano, P.S. ‘‘Understanding Food Science and Technology’’. Belmont, California: Wadsworth/Thomas Learning; 2003; pp.123–125. 80. U.S. Food and Drug Administration. ‘‘Memorandum to the File: Summary of Comments Received to the 1999 CSPI Petition on Added Sugars, (Docket No. FDA–1999–P–0158 (formerly Docket No. 99P–2630))’’, 2014. 81. Life Sciences Research Office. ‘‘The Evaluation of the Energy of Certain Sugar Alcohols Used as Food Ingredients’’, Bethesda, MD: Life Sciences Research Office; 1994. 82. Life Sciences Research Office. ‘‘Evaluation of the Net Energy Value of Maltitol’’, Bethesda, MD: Life Sciences Research Office; 1999. 83. McCleary, B.V., DeVries, J.W., Rader, J.I., et al. ‘‘Determination of Total Dietary Fiber (CODEX definition) by EnzymaticGravimetric Method and Liquid Chromatography: Collaborative Study’’. Journal of AOAC International. 2010;93:221–233. 84. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 10: Protein and Amino Acids’’, Washington, DC: National Academies Press; 2002. 85. U.S. Department of Agriculture, Agricultural Research Service and the U.S. Department of Health and Human Services Centers for Disease Control and Prevention National Center for Health Statistics. (2010) ‘‘What We Eat in America, NHANES 2007–2008’’, Table 1. Nutrient Intakes from Food: Mean Amounts Consumed per Individual by Gender and Age, in the United States, 2007–2008. Retrieved from https:// www.ars.usda.gov/SP2UserFiles/Place/ 12355000/pdf/0708/Table_1_NIN_GEN_ 07.pdf. 86. Joint Food and Agriculture Organization of the United States and World Health Organization. ‘‘Protein Quality Evaluation, Report of Joint FAO/WHO Expert Consultation’’, Rome: Food and Agriculture Organization of the United Nations; 1991. 87. Institute of Medicine (IOM) of the National Academies. ‘‘Sodium Intake in Populations: Assessment of Evidence’’, Washington, DC: National Academies Press; 2013. pp. 235–284. 88. National Research Council (NRC). ‘‘Diet and Health: Implications for Reducing Chronic Disease Risk’’, Washington, DC: National Academy Press; 1989. 89. Institute of Medicine (IOM) of the National Academies. ‘‘Strategies to Reduce Sodium Intake in the United States, Chapter 8: Committee’s Considerations and Basis for Recommendations’’, Washington, DC: National Academies Press; 2010. pp. 235–284. PO 00000 Frm 00086 Fmt 4701 Sfmt 4702 90. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride, Chapter 8: Fluoride’’, Washington, DC: National Academies Press; 1997. pp. 288–313. 91. U.S. Food and Drug Administration. (July 15, 2009) ‘‘Health Claim Notification for Fluoridated Water and Reduced Risk of Dental Caries’’, October 14, 2006. Retrieved from https://www.fda.gov/ Food/IngredientsPackagingLabeling/ LabelingNutrition/ucm073602.htm. 92. U.S. Environmental Protection Agency, Health and Ecological Criteria Division Office of Water. (December, 2010) ‘‘Fluoride: Exposure and Relative Source Contribution Analysis’’. Retrieved from https://water.epa.gov/action/advisories/ drinking/fluoride_index.cfm. 93. U.S. Department of Health and Human Services. ‘‘The Surgeon General’s Report on Nutrition and Health’’, Washington, DC: 1988. 94. Life Sciences Research Office (LSRO), prepared by by the Department of Health and Human Services. ‘‘Nutrition Monitoring in the United States, An Update Report on Nutrition Monitoring’’, Washington DC: Government Printing Office; 1989. 95. Institute of Medicine (IOM) of the National Academies. ‘‘Nutrition Labeling: Issues and Directions for the 1990s’’, Washington, DC: National Academy Press; 1990. 96. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes: Applications in Dietary Assessment’’, Washington DC: National Academies Press; 2000. 97. Gibson R.S. Principles of Nutrition Assessment. 2nd Ed. New York: Oxford University Press, 2005; pp. 373, 513, 534, 602–606. 98. U.S. Department of Health and Human Services. (October 14, 2004) ‘‘Bone Health and Osteoporosis: A Report of the Surgeon General’’. Retrieved from https:// www.surgeongeneral.gov/library/reports/ bonehealth/. 99. Looker, A.C., Melton, L.J., III, Harris, T.B., et al. ‘‘Prevalence and Trends in Low Femur Bone Density Among Older US Adults: NHANES 2005–2006 Compared with NHANES III’’. Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research. 2010;25:64–71. 100. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Chapter 9: Iron’’, Washington, DC: National Academies Press; 2001. pp. 290–393. 101. Centers for Disease Control and Prevention, National Center for Environmental Health Division of Laboratory Sciences. (2012) ‘‘Second National Report on Biochemical Indicators of Diet and Nutrition in the U.S. Population’’. Retrieved from E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules https://www.cdc.gov/nutritionreport/pdf/ Nutrition_Book_complete508_ final.pdf#zoom=100. 102. Cook, J.D., Flowers, C.H., Skikne, B.S. ‘‘The Quantitative Assessment of Body Iron’’. Blood. 2003;101:3359–3364. 103. Cogswell, M.E., Looker, A.C., Pfeiffer, C.M., et al. ‘‘Assessment of Iron Deficiency in US Preschool Children and Nonpregnant Females of Childbearing Age: National Health and Nutrition Examination Survey 2003–2006’’. American Journal of Clinical Nutrition. 2009;89:1334–1342. 104. U.S. Department of Health and Human Services. (September 1, 2011) Healthy People 2020, Nutrition and Weight Status; Iron Deficiency Anemia (objective NWS–21): ‘‘Reduce Iron Deficiency Among Young Children and Females of Childbearing Age’’. Retrieved from https://www.healthypeople.gov/ 2020/topicsobjectives2020/objectives list.aspx?topicid=29. 105. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Chapter 4: Vitamin A’’, Washington, DC: National Academies Press; 2001. pp. 82– 161. 106. The Alpha-Tocopherol, B.C.C.P.S.G. ‘‘The Effect of Vitamin E and Beta Carotene on the Incidence of Lung Cancer and Other Cancers in Male Smokers.’’. New England Journal of Medicine. 1994;330:1029–1035. 107. Omenn, G.S., Goodman, G.E., Thornquist, M.D., et al. ‘‘Effects of a Combination of Beta Carotene and Vitamin A on Lung Cancer and Cardiovascular Disease’’. New England Journal of Medicine. 1996;334:1150– 1155. 108. U.S. Food and Drug Administration. (2009) ‘‘Antioxidant Vitamins C and E and Reduction in the Risk of SiteSpecific Cancers’’. Retrieved from https:// www.fda.gov/food/ingredientspackaging labeling/labelingnutrition/ ucm166913.htm. 109. U.S. Food and Drug Administration. (November 13, 2011) ‘‘Guidance for Industry: Estimating Dietary Intake of Substances in Food’’. Retrieved from https://www.fda.gov/food/ guidanceregulation/guidancedocuments regulatoryinformation/ingredient sadditivesgraspackaging/ ucm074725.htm. 110. Cappuccio, F.P., MacGregor, G.A. ‘‘Does Potassium Supplementation Lower Blood Pressure? A Meta-Analysis of Published Trials’’. Journal of Hypertension. 1991;9:465–473. 111. Whelton, P.K., He, J., Cutler, J.A., et al. ‘‘Effects of Oral Potassium on Blood Pressure. Meta-Analysis of Randomized Controlled Clinical Trials’’. JAMA: The Journal of the American Medical Association. 1997;277:1624–1632. 112. Geleijnse, J.M., Kok, F.J., Grobbee, D.E. ‘‘Blood Pressure Response to Changes in Sodium and Potassium Intake: a VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Metaregression Analysis of Randomised Trials’’. Journal of Human Hypertension. 2003;17:471–480. 113. Centers for Disease Control and Prevention. (2012) ‘‘High Blood Pressure Facts’’. Retrieved from https:// www.cdc.gov/bloodpressure/facts.htm. 114. U.S. Food and Drug Administration. (2000) ‘‘Health Claim: Diets Containing Foods That Are Good Sources of Potassium and Low in Sodium May Reduce the Risk of High Blood Pressure and Stroke’’. Retrieved from https:// www.fda.gov/food/ingredientspackaging labeling/labelingnutrition/ ucm073606.htm. 115. U.S. Food and Drug Administration. ‘‘Memorandum to the File: Declaration of Current Voluntarily Declared Essential Vitamins and Minerals and Choline’’, 2014. 116. Hill, K.M., Jonnalagadda, S.S., Albertson, A.M., et al. ‘‘Top Food Sources Contributing to Vitamin D Intake and the Association of Ready-to-Eat Cereal and Breakfast Consumption Habits to Vitamin D Intake in Canadians and United States Americans’’. Journal of Food Science. 2012;77:H170–H175. 117. U.S. Census Bureau, Population Projections Program Population Division. ‘‘(NP–D1–A) Projections of the Resident Population by Age, Sex, Race, and Hispanic Origin: 1999 to 2100’’, Washington, DC: U.S. Census Bureau; January 13, 2000. 118. World Health Organization. (2007) ‘‘Assessment of Iodine Deficiency Disorders and Monitoring Their Elimination: A Guide for Programme Managers’’. 3rd Ed. Retrieved from https://whqlibdoc.who.int/publications/ 2007/9789241595827_eng.pdf. 119. Beaton, G.H. ‘‘When Is an Individual an Individual Versus a Member of a Group? An Issue in the Application of the Dietary Reference Intakes’’. Nutrition Reviews. 2006;64:211–225. 120. Borra, S. ‘‘Consumer Perspectives on Food Labels’’. American Journal of Clinical Nutrition. 2006;83:1235S– 1235S. 121. Fulgoni, V.L., III, Miller, G.D. ‘‘Dietary Reference Intakes for Food Labeling’’. American Journal of Clinical Nutrition. 2006;83:1215S–1216S. 122. Kretser, A.J. ‘‘The New Dietary Reference Intakes in Food Labeling: The Food Industry’s Perspective’’. American Journal of Clinical Nutrition. 2006;83:1231S–1234S. 123. Murphy, S.P., Barr, S.I., Yates, A.A. ‘‘The Recommended Dietary Allowance (RDA) Should Not Be Abandoned: An Individual Is Both an Individual and a Member of a Group’’. Nutrition Reviews. 2006;64:313–315. 124. Murphy, S.P., Barr, S.I. ‘‘Recommended Dietary Allowances Should Be Used to Set Daily Values for Nutrition Labeling’’. American Journal of Clinical Nutrition. 2006;83:1223S–1227S. 125. Tarasuk, V. ‘‘Use of PopulationWeighted Estimated Average Requirements as a Basis for Daily Values on Food Labels’’. American Journal of PO 00000 Frm 00087 Fmt 4701 Sfmt 4702 11965 Clinical Nutrition. 2006;83:1217S– 1222S. 126. Yates, A.A. ‘‘Which Dietary Reference Intake Is Best Suited to Serve as the Basis for Nutrition Labeling for Daily Values?’’. The Journal of Nutrition. 2006;136:2457– 2462. 127. International Food Information Council (IFIC) Foundation. (2007) ‘‘2007 Food & Health Survey: Consumer Attitudes Toward Food, Nutrition & Health’’. Retrieved from https:// www.foodinsight.org/Content/6/ 2007Survey-FINAL.pdf. 128. International Food Information Council (IFIC) Foundation. (2010) ‘‘2010 Food & Health Survey: Consumer Attitudes Toward Food Safety, Nutrition & Health’’. Retrieved from https:// www.foodinsight.org/Resources/ Detail.aspx?topic=2010_Food_Health_ Survey_Consumer_Attitudes_Toward_ Food_Safety_Nutrition_Health. 129. International Food Information Council (IFIC) Foundation. (2006) ‘‘2006 Food & Health Survey: Consumer Attitudes Toward Food, Nutrition & Health’’. Retrieved from https:// www.foodinsight.org/Resources/ Detail.aspx?topic=Food_Health_Survey_ Consumer_Attitudes_toward_Food_ Nutrition_Health_2006_. 130. International Food Information Council (IFIC) Foundation. (2009) ‘‘2009 Food & Health Survey: Consumer Attitudes Toward Food, Nutrition & Health’’. Retrieved from https:// www.foodinsight.org/Resources/ Detail.aspx?topic=2009_Food_Health_ Survey_Consumer_Attitudes_toward_ Food_Nutrition_and_Health. 131. U.S. Department of Agriculture, Center for Nutrition Policy and Promotion. (2011) ‘‘USDA Food Patterns, Comparison of Nutrient Content of Each 2010 USDA Food Pattern to Nutrition Goals for That Pattern’’. Retrieved from https://www.cnpp.usda.gov/Publications/ USDAFoodPatterns/Comparisonof NutrientContentofeach2010USDAFood PatterntoNutritionalGoalsforthat Pattern.pdf. 132. U.S. Food and Drug Administration. ‘‘Memorandum to the File: Documentation for the Methodology Used to Determine Total Usual Intakes of Vitamins and Minerals Compared to Tolerable Upper Levels (UL) and Results of Analysis’’, 2014. 133. Block L., Peracchio L. ‘‘The Calcium Quandry: How Consumers Use Nutrition Labels’’. Journal of Public Policy Marketing. 2006;25:188–196. 134. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Chapter 5: Vitamin K’’, Washington, DC: National Academies Press; 2001. pp. 162–196. 135. National Research Council (NRC). ‘‘Recommended Dietary Allowances, 9th Ed.’’, Washington, DC: National Academy Press; 1980. E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11966 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 136. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate, Chapter 5: Potassium’’, Washington, DC: National Academies Press; 2005. pp. 186–268. 137. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline, Chapter 12: Choline’’, Washington, DC: National Academy Press; 1998. pp. 390– 422. 138. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. (August 30, 2001) ‘‘Nutrient Content Claims Notification for Choline Containing Foods’’. Retrieved from https://www.fda.gov/food/ ingredientspackaginglabeling/ labelingnutrition/ucm073599.htm. 139. O’Neil, C.E., Keast, D.R., Fulgoni, V.L., et al. ‘‘Food Sources of Energy and Nutrients Among Adults in the US: NHANES 2003–2006’’. Nutrients. 2012;4:2097–2120. 140. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Summary’’, Washington, DC: National Academies Press; 2001. pp. 1–28. 141. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline, Chapter 8: Folate’’, Washington, DC: National Academy Press; 1998. pp. 196– 305. 142. U.S. Pharmacopeia. ‘‘The National Formulary, 15th Ed.’’, Rockville, MD: United States Pharmacopeial Convention, Inc.; 1980. pp. 846–847. 143. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids, Chapter 6: Vitamin E’’, Washington, DC: National Academies Press; 2000. pp. 186–283. 144. U.S. Food and Drug Administration, Office of Nutritional Products Labeling and Dietary Supplements. (2013) ‘‘Guidance for Industry: A Food Labeling Guide’’. Retrieved from https:// www.fda.gov/food/guidanceregulation/ guidancedocumentsregulatory information/labelingnutrition/ ucm2006828.htm. 145. Breastfeeding and the Use of Human Milk. Pediatrics. 2012;129:e827–e841. 146. U.S. Department of Health and Human Services, National Institutes of Health, and National, Heart Lung and Blood Institute. (October, 2012) ‘‘Integrated Guidelines for Cardiovascular Health and Risk Reduction In Children and Adolescents: The Report of the Expert Panel’’; NIH Publication No. 12–7486A. Retrieved from https:// www.nhlbi.nih.gov/guidelines/cvd_ped/ index.htm. 147. Akers, S., Groh-Wargo, S. ‘‘Chapter 5: Normal Nutrition During Infancy’’. In: VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 Pediatric Nutrition 4th Ed. Patrica Queen Samour and Kathy King, ed. Sadbury, MA: Jones and Bartlett Learning; 2012; p.71. 148. Devaney, B., Ziegler, P., Pac, S., et al. ‘‘Nutrient Intakes of Infants and Toddlers’’. Journal of the American Dietetic Association. 2004;104:s14–s21. 149. Fox, M.K., Reidy, K., Novak, T., et al. ‘‘Sources of Energy and Nutrients in the Diets of Infants and Toddlers’’. Journal of the American Dietetic Association. 2006;106:S28–S42. 150. Butte, N.F., Fox, M.K., Briefel, R.R., et al. ‘‘Nutrient Intakes of US Infants, Toddlers, and Preschoolers Meet or Exceed Dietary Reference Intakes’’. Journal of the American Dietetic Association. 2010;110:S27–S37. 151. American Academy of Pediatrics. ‘‘Chapter 32: Hyperlipidemia and Prevention of Cardiovascular Disease’’. In: Pediatric Nutrition Handbook 6th Ed. Kleinman, R.E., ed. American Academy of Pediatrics; 2009; p.723. 152. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride, Chapter 4: Calcium’’, Washington, DC: National Academies Press; 1997. pp. 71– 145. 153. Greer, F.R., Krebs, N.F. ‘‘Optimizing Bone Health and Calcium Intakes of Infants, Children, and Adolescents’’. Pediatrics. 2006;117:578–585. 154. Polhamus, B., Delenius, K., Makentosh, H., Smith, B., and Grummer-Strawn, L. (2011) ‘‘Pediatric Nutrition Surveillance 2009 Report’’. Retrieved from https:// www.cdc.gov/pednss/pdfs/PedNSS_ 2009.pdf. 155. Looker, A.C., Dallman, P.R., Carroll, M.D., et al. ‘‘Prevalence of Iron Deficiency in the United States’’. JAMA: the Journal of the American Medical Association. 1997;277:973–976. 156. Centers for Disease Control and Prevention. (September 9, 2010) ‘‘Growth Charts’’. Retrieved from https:// www.cdc.gov/growthcharts/who_ charts.htm. 157. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 1: Introduction to Dietary Reference Intakes’’, Washington, DC: National Academies Press; 2002. pp. 21– 37. 158. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Chapter 12: Zinc’’, Washington, DC: National Academies Press; 2001. pp. 442–501. 159. Cusick, S.E., Mei, Z., Freedman, D.S., et al. ‘‘Unexplained Decline in the Prevalence of Anemia Among US Children and Women Between 1988– 1994 and 1999–2002’’. American Journal of Clinical Nutrition. 2008;88:1611–1617. PO 00000 Frm 00088 Fmt 4701 Sfmt 4702 160. Gomez-Palacio B., Vit A. Graphic Design Referenced: A Visual Guide to the Language, Applications, and History of Graphic Design. 1st Ed. Beverly, MA: Rockport Publishers, 2012;pp. 50–54. 161. Levy, A., Fein, S.B., Schucker, R.E. ‘‘Nutrition Labeling Formats: Performance and Preference’’. Food Technology. 1991;45:116–121. 162. Levy, A.S., Fein, S.B., Schucker, R.E. ‘‘More Effective Nutrition Label Formats Are Not Necessarily Preferred’’. Journal of the American Dietetic Association. 1992;92:1230–1234. 163. Levy, A.S., Fein, S.B., Schucker, R.E. ‘‘Performance Characteristics of Seven Nutrition Label Formats’’. American Journal of Health Promotion. 1992;14:157–160. 164. Lando, A.M., Lo, S.C. ‘‘Single-LargerPortion-Size and Dual-Column Nutrition Labeling May Help Consumers Make More Healthful Food Choices’’. Journal of the Academy of Nutrition and Dietetics. 2013;113:241–250. 165. U.S. Food and Drug Administration. (December 5, 2012) ‘‘Calories Count: Report of the Working Group on Obesity’’, March 12, 2004. Retrieved from https://www.fda.gov/food/ foodscienceresearch/ consumerbehaviorresearch/ ucm081696.htm. 166. Knemeyer, D. (July 15, 2003) ‘‘Information Design: The Understanding Discipline’’. Retrieved from https:// boxesandarrows.com/informationdesign-the-understanding-discipline/. 167. Lidwell, W., Holden, K., Butler, J., editors. Universal Principles of Design. 1st Ed. Beverly, MA: Rockport Publishers, 2003;pp. 40–41. 168. Goldberg, J.H., Probart, C.K., Zak, R.E. ‘‘Visual Search of Food Nutrition Labels’’. Human Factors. 1999;41:425– 437. 169. Wogalter, M.S., Leonard, S.D. ‘‘Chapter 7: Attention Capture and Maintenance’’. In: Warnings in Risk Communication Philadelphia: Taylor and Francis Inc.; 1999; pp.123–148. 170. Wogalter, M.S., Vigilante, W.J., Jr. ‘‘Effects of Label Format on Knowledge Acquisition and Perceived Readability by Younger and Older Adults’’. Ergonomics. 2003;46:327–344. 171. Lupton E. Thinking With Type: A Critical Guide for Designers, Writers, Editors, & Students. 2nd Ed. New York, NY: Princeton Archetectural Press, 2010; pp. 132–133. 172. Marino, C.J., Mahan, R.R. ‘‘Configural Displays Can Improve Nutrition-Related Decisions: An Application of the Proximity Compatibility Principle’’. Human Factors. 2005;47:121–130. 173. Vessey, I., Galletta, D. ‘‘Cognitive Fit: An Empirical Study of Information Acquisition’’. Information Systems Research. 1991;2:63–84. 174. Campos, S.e.al. ‘‘Nutrition Labels on Pre-Packaged Foods: A Systematic Review’’. Public Health Nutrition. 2011;14:1496–1506. 175. Cowburn, G., Stockley L. ‘‘Consumer Understanding and Use of Nutrition E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules Labeling: A Systematic Review’’. Public Health Nutrition. 2005;8:21–28. 176. Fagerlin A., Peters E. ‘‘Quantitative Information (Chapter 7)’’. In: Communicating Risks and Benefits: An Evidence-Based User’s Guide Ed. Fischhoff, B., Brewer, N.T., Downs, J.S., eds. Silver Spring, MD: U.S. Food and Drug Administration, U.S. Department of Health and Human Services; 2011; pp.53–62. 177. Li, F., Miniard, P.W., Barone, M.J. ‘‘The Facilitating Influence of Consumer Knowledge on the Effectiveness of Daily Value Reference Information’’. Journal of the Academy of Marketing Science. 2000;28:425–436. 178. Riis J., Ratner R. ‘‘Simplified Nutrition Guidelines to Fight Obesity’’. In: Leveraging Consumer Psychology for Effective Health Communications—The Obesity Challenge Ed. Batra, R., Keller, P.A., Strecher, V.J., eds. Armonk, NY: Society for Consumer Psychology, M.E. Sharp; 2011. 179. U.S. Food and Drug Administration. (2014) ‘‘Spot the Block Campaign’’. Retrieved from https://www.fda.gov/food/ ingredientspackaginglabeling/ labelingnutrition/ucm281746.htm. 180. U.S. Food and Drug Administration. (March 13, 2013) ‘‘A Key to Choosing Healthful Foods: Using the Nutrition Facts on the Food Label’’. Retrieved from https://www.fda.gov/Food/ ResourcesForYou/Consumers/ ucm079449.htm. 181. U.S. Food and Drug Administration, Office of Nutrition Labeling and Dietary Supplements. ‘‘Memorandum to the File: Documentation of Web sites that Use the 5/20 Rule’’, 2014. 182. White A. The Elements of Graphic Design. 2nd Ed. New York, NY: Allworth Press, 2011;pp. 167–169, 187. 183. Dictionary.com Unabridged. (2014) ‘‘Carb’’. Retrieved from https:// dictionary.reference.com/browse/carb. 184. Google. (2014) Google Trends Search Terms ‘‘Total Carb’’ and ‘‘Total Carbs’’. Retrieved from https://www.google.com/ trends/. 185. Kessler D.A., Mande J.R., Scarbrough E., et al. ‘‘Developing the ‘‘Nutrition Facts’’ Food Label’’. Harvard Health Policy Review. 2003;4:13–24. 186. Viswanathan, M., Hastak, M., Gau, R. ‘‘Understanding and Facilitating the Usage of Nutritional Labels by LowLiterate Consumers’’. Journal of Public Policy Marketing. 2009;28:135–145. 187. U.S. Food and Drug Administration. ‘‘Preliminary Regulatory Impact Analysis (PRIA) for the Food Labeling: Revision of the Nutrition and Supplement Facts Labels Notice of Proposed Rulemaking (Docket No. FDA–2012–N–1210) and Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments Notice of Proposed Rulemaking (Docket No. FDA–2004–N– 0258)’’, 2014. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 188. U.S. Food and Drug Administration. ‘‘Environmental Assessment for the Revision of the Nutrition and Supplement Facts Labels’’, February 14,2014. 189. U.S. Food and Drug Administration. ‘‘Finding of No Significant Impact for the Proposed Revisions to the Nutrition and Supplement Facts Labels’’, February 13, 2014. List of Subjects in 21 CFR Part 101 Food labeling, Nutrition, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 101 be amended as follows: PART 101—FOOD LABELING 1. The authority for 21 CFR part 101 continues to read as follows: ■ Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271. 2. In § 101.9: a. Revise paragraphs (c) introductory text, (c)(1)(i)(A), (c)(1)(i)(C) through (E) (c)(2) introductory text, (c)(5), (c)(6)(i), (c)(6)(iii) and (iv), (c)(7), (c)(8) introductory text, (c)(8)(i), (c)(8)(ii) introductory text, (c)(8)(iii) through (v), (c)(9), (d)(1) introductory text, (d)(1)(ii)(C), (d)(1)(iii) through (v), (d)(2), (d)(3)(i) and (ii), (d)(4) through (8), (d)(10) through (12), (d)(13)(ii), (e), (f) introductory text, (f)(2)(ii), (f)(4) and (5), (g) introductory text, (g)(2), (g)(3)(ii), (g)(4) through (8), (h)(3)(iv), (h)(4) introductory text, (j)(5)(i), (j)(5)(ii) introductory text, (j)(5)(ii)(A), (j)(13)(ii)(A)(1) and (2), (j)(13)(ii)(B) and (C), and (j)(18)(iv) introductory text. ■ b. Remove paragraph (c)(1)(ii), redesignate paragraph (c)(1)(iii) as (c)(1)(ii), and revise newly designated paragraph (c)(1)(ii); ■ c. Remove paragraph (c)(6)(iv), redesignate paragraph (c)(6)(iii) as (c)(6)(iv), and add new paragraph (c)(6)(iii); ■ d. Add paragraphs (c)(1)(i)(F), (c)(8)(vii), (g)(10), and (g)(11); ■ e. Remove and reserve paragraph (d)(9); ■ f. Remove paragraphs (e)(3)(i) and (e)(3)(ii); and ■ j. Remove paragraphs (j)(5)(ii)(B) through (j)(5)(ii)(D), and redesignate paragraph (j)(5)(ii)(E) as (j)(5)(ii)(B). The revisions read as follows: ■ ■ § 101.9 Nutrition labeling of food. * * * * * (c) The declaration of nutrition information on the label and in labeling of food for adults and children over the age of 4 years, and on foods (other than PO 00000 Frm 00089 Fmt 4701 Sfmt 4702 11967 infant formula) purported to be specifically for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women, shall contain information about the level of the following nutrients, except for those nutrients whose inclusion, and the declaration of the amounts, is voluntary as set forth in this paragraph. No nutrients or food components other than those listed in this paragraph as either mandatory or voluntary may be included within the nutrition label. Except as provided for in paragraphs (f) or (j) of this section, nutrient information shall be presented using the nutrient names specified and in the following order in the formats specified in paragraphs (d) or (e) of this section. (1) * * * (i) * * * (A) Using specific Atwater factors (i.e., the Atwater method) given in table 13, ‘‘Energy Value of Foods—Basis and Derivation,’’ by A. L. Merrill and B. K. Watt, United States Department of Agriculture (USDA) Handbook No. 74 (slightly revised, 1973), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is available from the Office of Nutrition, Labeling, and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be inspected at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.archives.gov/ federal_register/code_of_federal_ regulations/ibr_locations.html.; * * * * * (C) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate (less the amount of nondigestible carbohydrates and sugar alcohols), and total fat, respectively, as described in USDA Handbook No. 74 (slightly revised 1973) pp. 9–11, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section). A general factor of 2 calories per gram for soluble non-digestible carbohydrates shall be used. The general factors for caloric value of sugar alcohols provided in paragraph (c)(1)(i)(F) of this section shall be used; (D) Using data for specific food factors for particular foods or ingredients approved by the Food and Drug Administration (FDA) and provided in parts 172 or 184 of this chapter, or by other means, as appropriate; E:\FR\FM\03MRP2.SGM 03MRP2 11968 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules (E) Using bomb calorimetry data subtracting 1.25 calories per gram protein to correct for incomplete digestibility, as described in USDA Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section); mstockstill on DSK4VPTVN1PROD with PROPOSALS2 or (F) Using the following general factors for caloric value of sugar alcohols: Isomalt—2.0 calories per gram, lactitol—2.0 calories per gram, xylitol— 2.4 calories per gram, maltitol—2.1 calories per gram, sorbitol—2.6 calories per gram, hydrogenated starch hydrolysates—3.0 calories per gram, and mannitol—1.6 calories per gram. (ii) ‘‘Calories from saturated fat’’ or ‘‘Calories from saturated’’ (VOLUNTARY): A statement of the caloric content derived from saturated fat as defined in paragraph (c)(2)(i) of this section in a serving may be declared voluntarily, expressed to the nearest 5calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. This statement shall be indented under the statement of calories as provided in paragraph (d)(5) of this section. (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A statement of the number of grams of total fat in a serving defined as total lipid fatty acids and expressed as triglycerides where fatty acids are aliphatic carboxylic acids consisting of a chain of alkyl groups and characterized by a terminal carboxyl group. Amounts shall be expressed to the nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero. * * * * * (5) ‘‘Fluoride’’ (VOLUNTARY): A statement of the number of milligrams of fluoride in a specified serving of food may be declared voluntarily, except that when a claim is made about fluoride content, label declaration shall be required. Fluoride content shall be expressed as zero when the serving contains less than 0.1 milligrams of fluoride, to the nearest 0.1-milligram increment when the serving contains less than or equal to 0.8 milligrams of fluoride, and the nearest 0.2 milligramincrement when a serving contains more than 0.8 milligrams of fluoride. (6) * * * VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 (i) ‘‘Dietary fiber’’: A statement of the number of grams of total dietary fiber in a serving, indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required or, alternatively, the statement ‘‘Contains less than 1 gram’’ or ‘‘less than 1 gram’’ may be used, and if the serving contains less than 0.5 gram, the content may be expressed as zero. Dietary fiber is defined as non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants; isolated and synthetic non-digestible carbohydrates (with 3 or more monomeric units) that FDA has granted be included in the definition of dietary fiber, in response to a petition submitted to FDA under § 10.30 (21 CFR 10.30) demonstrating that such carbohydrates have a physiological effect(s) that is beneficial to human health; or isolated and synthetic non-digestible carbohydrates (with 3 or more monomeric units) that are the subject of an authorized health claim. Except as provided for in paragraph (f) of this section, if dietary fiber content is not required, and as a result not declared, the statement ‘‘Not a significant source of dietary fiber’’ shall be placed at the bottom of the table of nutrient values in the same type size. Dietary fiber content may be determined by subtracting the amount of non-digestible carbohydrates added during processing that do not meet the definition of dietary fiber from the value obtained using AOAC 2009.01, AOAC 2011.25, or an equivalent method of analysis as given in the ‘‘Official Methods of Analysis of the AOAC International,’’ 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 in paragraph (g)(2). The following isolated and synthetic non-digestible carbohydrate(s) have been determined by FDA to have physiological effects that are beneficial to human health and, therefore, shall be included in the calculation of the amount of dietary fiber: b-glucan soluble fiber (as described in § 101.81(c)(2)(ii)(A)) and barley b-fiber (as described in § 101.81(c)(2)(ii)(A)(6)). Manufacturers may submit a citizen petition in accordance with the requirements of § 10.30 to request that FDA allow for the declaration of the gram amount of an isolated and synthetic non-digestible carbohydrate or a health claim petition in accordance with the requirements of § 101.70 for an isolated and synthetic non-digestible carbohydrate. The manufacturer must make and keep records in accordance PO 00000 Frm 00090 Fmt 4701 Sfmt 4702 with paragraphs (g)(10) and (g)(11) of this section to verify the declared amount of dietary fiber in the label and labeling of food when a mixture of dietary fiber, and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber, is present in the food. (A) ‘‘Soluble fiber’’ (VOLUNTARY): A statement of the number of grams of soluble dietary fiber in a serving may be declared voluntarily except that when a claim is made on the label or in labeling about soluble fiber, label declaration shall be required. Soluble fiber must meet the definition of dietary fiber in this paragraph (c)(6)(i). Soluble fiber may be determined using AOAC 2011.25 or an equivalent method of analysis as given in the ‘‘Official Methods of Analysis of the AOAC International,’’ 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 in paragraph (g)(2). The manufacturer must make and keep records in accordance with paragraphs (g)(10) and (g)(11) of this section to verify the declared amount of soluble fiber in the label and labeling of food when a mixture of soluble fiber and added nondigestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food. Soluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ‘‘Contains less than 1 gram’’ or ‘‘less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.’’ (B) ‘‘Insoluble fiber’’ (VOLUNTARY): A statement of the number of grams of insoluble dietary fiber in a serving may be declared voluntarily except that when a claim is made on the label or in labeling about insoluble fiber, label declaration shall be required. Insoluble fiber must meet the definition of dietary fiber in this paragraph (c)(6)(i). Insoluble fiber may be determined using AOAC 2011.25 or an equivalent method of analysis as given in the ‘‘Official Methods of Analysis of the AOAC International,’’ 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 in paragraph (g)(2) of this section. The manufacturer must make and keep records in accordance with paragraphs (g)(10) and (g)(11) of this section to verify the declared amount of insoluble fiber in the label and labeling of food when a mixture of insoluble and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food. Insoluble fiber content shall be indented under dietary E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ‘‘Contains less than 1 gram’’ or ‘‘less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.’’ * * * * * (iii) ‘‘Added Sugars’’: A statement of the number of grams of added sugars in a serving, except that label declaration of added sugars content is not required for products that contain less than 1 gram of added sugars in a serving if no claims are made about sweeteners, sugars, added sugars, or sugar alcohol content. If a statement of the added sugars content is not required and, as a result, not declared, the statement ‘‘Not a significant source of added sugars’’ shall be placed at the bottom of the table of nutrient values in the same type size. Added sugars shall be defined as sugars that are either added during the processing of foods, or are packaged as such, and include sugars (free, monoand disaccharides), syrups, naturally occurring sugars that are isolated from a whole food and concentrated so that sugar is the primary component (e.g., fruit juice concentrates), and other caloric sweeteners. Added sugars content shall be indented under sugars and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ‘‘Contains less than 1 gram’’ or ‘‘less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When a mixture of naturally occurring and added sugars is present in the food, and for specific foods containing added sugars, alone or in combination with naturally occurring sugars, where the added sugars are subject to fermentation, the manufacturer must make and keep records in accordance with paragraphs (g)(10) and (g)(11) of this section to verify the declared amount of added sugars in the label and labeling of food. (iv) ‘‘Sugar alcohol’’ (VOLUNTARY): A statement of the number of grams of sugar alcohols in a serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the food, sugar alcohol content shall be declared. For nutrition labeling purposes, sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 of the term ‘‘sugar alcohol,’’ the name of the specific sugar alcohol (e.g., ‘‘xylitol’’) present in the food may be used in the nutrition label provided that only one sugar alcohol is present in the food. Sugar alcohol content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ‘‘Contains less than 1 gram’’ or ‘‘less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. (7) ‘‘Protein’’: A statement of the number of grams of protein in a serving, expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ‘‘Contains less than 1 gram’’ or ‘‘less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When the protein in foods represented or purported to be for adults and children 4 or more years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 20 expressed as a percent, or when the protein in a food represented or purported to be for children greater than 1 but less than 4 years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 40 expressed as a percent, either of the following shall be placed adjacent to the declaration of protein content by weight: The statement ‘‘not a significant source of protein,’’ or a listing aligned under the column headed ‘‘Percent Daily Value’’ of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, for protein and expressed as a Percent of Daily Value. When the protein quality in a food as measured by the Protein Efficiency Ratio (PER) is less than 40 percent of the reference standard (casein) for a food represented or purported to be specifically for infants 7 through 12 months, the statement ‘‘not a significant source of protein’’ shall be placed adjacent to the declaration of protein content. Protein content may be calculated on the basis of the factor 6.25 times the nitrogen content of the food as determined by the appropriate method of analysis as given in the ‘‘Official Methods of Analysis of the AOAC International,’’ 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, except when the official procedure for a specific food requires another factor. PO 00000 Frm 00091 Fmt 4701 Sfmt 4702 11969 Copies may be obtained from AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be inspected at the National Archives and Records Administration (NARA). For more information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.archives.gov/ federal_register/code_of_federal_ regulations/ibr_locations.html. (i) A statement of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value, may be placed on the label, except that such a statement shall be given if a protein claim is made for the product, or if the product is represented or purported to be specifically for infants 7 through 12 months or children 1 through 3 years of age. When such a declaration is provided, it should be placed on the label adjacent to the statement of grams of protein and aligned under the column headed ‘‘Percent Daily Value,’’ and expressed to the nearest whole percent. However, the percentage of the RDI for protein shall not be declared if the food is represented or purported to be specifically for infants 7 through 12 months and the protein quality value is less than 40 percent of the reference standard. (ii) The ‘‘corrected amount of protein (gram) per serving’’ for foods represented or purported for adults and children 1 or more years of age is equal to the actual amount of protein (gram) per serving multiplied by the amino acid score corrected for protein digestibility. If the corrected score is above 1.00, then it shall be set at 1.00. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8.00 in ‘‘Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,’’ Rome, 1991, except that when official AOAC procedures described in this paragraph (c)(7) require a specific food factor other than 6.25, that specific factor shall be used. The ‘‘Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation’’ as published by the Food and Agriculture Organization of the United Nations/World Health Organization is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is available from the Office of Nutrition, Labeling, and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug E:\FR\FM\03MRP2.SGM 03MRP2 11970 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be inspected at the National Archives and Records Administration (NARA). For more information on the availability of this material at NARA, call 202–741– 6030, or go to: https://www.archives.gov/ federal_register/code_of_federal_ regulations/ibr_locations.html. For foods represented or purported to be specifically for infants 7 through 12 months, the corrected amount of protein (grams) per serving is equal to the actual amount of protein (grams) per serving multiplied by the relative protein quality value. The relative protein quality value shall be determined by dividing the subject food protein PER value by the PER value for casein. If the relative protein value is above 1.00, it shall be set at 1.00. (iii) For the purpose of labeling with a percent of the DRV or RDI, a value of 50 grams of protein shall be the DRV for adults and children 4 or more years of age, a value of 11 grams of protein shall be the RDI for infants 7 through 12 months, a value of 13 grams shall be the DRV for children 1 through 3 years of age, and a value of 71 grams of protein shall be the RDI for pregnant and lactating women. (8) Vitamins and minerals: A statement of the amount per serving of the vitamins and minerals as described in this paragraph, expressed as a quantitative amount by weight using the appropriate unit of measure provided in paragraph (c)(8)(iv) of this section and as a percent of Daily Value calculated as a percent of the RDI provided in paragraph (c)(8)(iv) of this section. (i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d), (e), and (f) of this section, foods represented or purported to be specifically for infants 7 through 12 months, children 1 through 3 years, and pregnant and lactating women shall use the RDIs that are specified for the intended group. For foods represented or purported to be specifically for both infants 7 through 12 months and children 1 through 3 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants 7 through 12 months and children 1 through 3 years of age. When such dual declaration is used on any label, it shall be included in all labeling, and equal prominence shall be given to both values in all such labeling. The percent Daily Value based on the RDI values for pregnant and lactating women shall be declared on food represented or purported to be specifically for pregnant and lactating women. All other foods shall use the RDI for adults and children 4 or more years of age. (ii) The declaration of vitamins and minerals as a quantitative amount by weight and percent of the RDI shall include vitamin D, calcium, iron, and potassium in that order, for infants 7 through 12 months, children 1 through 3 years of age, pregnant and lactating women, and adults and children 4 or more years of age. The declaration of vitamins and minerals as a quantitative amount by weight and percent of the RDI shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added as a nutrient supplement, or when a claim is made about them. Other vitamins and minerals need not be declared if neither the nutrient nor the component is otherwise referred to on the label or the labeling or advertising and the vitamins and minerals are: * * * * * (iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment above 10 percent and up to and including the 50percent level. Quantitative amounts and percentages of vitamins and minerals present at less than 2 percent of the RDI are not required to be declared in nutrition labeling but may be declared by a zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement ‘‘Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients)’’ or ‘‘Contains < 2 percent of the Daily Value of this (these) nutrient (nutrients).’’ Alternatively, except as provided for in paragraph (f) of this section, if vitamin D, calcium, iron, or potassium is present in amounts less than 2 percent of the RDI, label declaration of the nutrient(s) is not required if the statement ‘‘Not a significant source of ll (listing the vitamins or minerals omitted)’’ is placed at the bottom of the table of nutrient values. Either statement shall be in the same type size as nutrients that are indented. The quantitative amounts of vitamins and minerals, excluding sodium, shall be the amount of the vitamin or mineral included in one serving of the product, using the units of measurement and the levels of significance given in paragraph (c)(8)(iv) of this section, except that zeros following decimal points may be dropped, and additional levels of significance may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole milligrams, but the quantitative amount may be declared in tenths of a milligram). (iv) The following RDIs, nomenclature, and units of measure are established for the following vitamins and minerals which are essential in human nutrition: RDI mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Nutrient Unit of measure Vitamin A ....................................... Vitamin C ...................................... Calcium ......................................... Iron ................................................ Vitamin D ...................................... Vitamin E ....................................... Vitamin K ....................................... Thiamin ......................................... Riboflavin ...................................... Niacin ............................................ Vitamin B6 ..................................... Folate 3 .......................................... Vitamin B12 .................................... Biotin ............................................. Pantothenic acid ........................... Micrograms RAE 1 (mcg) ............. Milligrams (mg) ............................. Milligrams (mg) ............................. Milligrams (mg) ............................. Micrograms (mcg) ........................ Milligrams (mg) ............................. Micrograms (mcg) ........................ Milligrams (mg) ............................. Milligrams (mg) ............................. Milligrams NE 2 (mg) .................... Milligrams (mg) ............................. Micrograms DFE 4 (mcg) .............. Micrograms (mcg) ........................ Micrograms (mcg) ........................ Milligrams (mg) ............................. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00092 Adults and children ≥ 4 years Fmt 4701 900 90 1,300 18 20 15 120 1.2 1.3 16 1.7 400 2.4 30 5 Sfmt 4702 Infants 7 through 12 months Children 1 through 3 years Pregnant and lactating women 300 15 700 7 15 6 30 0.5 0.5 6 0.5 150 0.9 8 2 1,300 120 1,300 27 15 19 90 1.4 1.6 18 2.0 600 2.8 35 7 500 50 260 11 10 5 2.5 0.3 0.4 4 0.3 80 0.5 6 1.8 E:\FR\FM\03MRP2.SGM 03MRP2 11971 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules RDI Nutrient Unit of measure Phosphorous ................................. Iodine ............................................ Magnesium .................................... Zinc ............................................... Selenium ....................................... Copper .......................................... Manganese ................................... Chromium ...................................... Molybdenum .................................. Chloride ......................................... Potassium ..................................... Choline .......................................... Protein ........................................... Milligrams (mg) ............................. Micrograms (mcg) ........................ Milligrams (mg) ............................. Milligrams (mg) ............................. Micrograms (mcg) ........................ Milligrams (mg) ............................. Milligrams (mg) ............................. Micrograms (mcg) ........................ Micrograms (mcg) ........................ Milligrams (mg) ............................. Milligrams (mg) ............................. Milligrams (mg) ............................. Grams (g) ..................................... Infants 7 through 12 months Adults and children ≥ 4 years 1,250 150 420 11 55 0.9 2.3 35 45 2,300 4,700 550 N/A Children 1 through 3 years Pregnant and lactating women 460 90 80 3 20 0.3 1.2 11 17 1500 3000 200 N/A 1,250 290 400 13 70 1.3 2.6 45 50 2300 5100 550 5 71 275 130 75 3 20 0.2 0.6 5.5 3 570 700 150 11 A percent daily value must be declared on the label for bolded nutrients. 1 RAE = Retinol activity equivalents; 1 RAE = 1 microgram retinol, 12 micrograms b-carotene, or 24 micrograms a-carotene, or 24 micrograms b-cryptoxanthin. 2 NE = Niacin equivalents, 1 milligram niacin = 60 milligrams of tryptophan. 3 ‘‘Folic Acid’’ must be used for purposes of declaration in the labeling of dietary supplements. It must also be declared in mcg DFE. 4 DFE = Dietary folate equivalents; 1 DFE = 1 microgram food folate = 0.6 micrograms folic acid from fortified food or as a supplement consumed with food = 0.5 micrograms of a supplement. 5 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant and lactating women. (v) The following synonyms may be added in parentheses immediately following the name of the nutrient or dietary component: Riboflavin—Vitamin B2 * * * * * (vii) When the amount of folate is declared in the labeling of a conventional food, the nutrient name ‘‘folate’’ shall be listed for products containing either folate alone or a mixture of folate and folic acid. The Calories—Energy Vitamin C—Ascorbic acid Thiamin—Vitamin B1 name of the synthetic form of the nutrient, ‘‘folic acid’’ shall be used when the nutrient is declared in the labeling of dietary supplements. (9) The following DRVs, nomenclature, and units of measure are established for the following food components: DRV Food component Unit of measurement Fat ..................................................... Saturated fatty acids ......................... Cholesterol ........................................ Total carbohydrate ............................ Sodium .............................................. Dietary fiber ....................................... Protein ............................................... Grams (g) ......................................... Grams (g) ......................................... Milligrams (mg) ................................. Grams (g) ......................................... Milligrams (mg) ................................. Grams (g) ......................................... Grams (g) ......................................... 1 Based mstockstill on DSK4VPTVN1PROD with PROPOSALS2 2 Based Adults and children ≥ 4 years Infants 7 through 12 months 1 65 30 N/A N/A 95 N/A N/A N/A 1 20 300 1 300 2,300 1 28 1 50 Children 1 through 3 years Pregnant and lactating women 2 39 1 65 2 10 1 20 300 2 150 1,500 2 14 2 13 300 1 300 2,300 1 28 N/A on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant and lactating women on the reference caloric intake of 1,000 calories for children 1 through 3 years of age. (d)(1) Nutrient information specified in paragraph (c) of this section shall be presented on foods in the following format, as shown in paragraph (d)(12) of this section, except on foods where the tabular display is permitted as provided for in paragraph (d)(11) of this section, on which dual columns of nutrition information are declared as provided for in paragraph (e) of this section, on those food products on which the simplified format is required to be used as provided for in paragraph (f) of this section, on foods for infants 7 months to 12 months of age and children 1 through 3 years of age as provided for in paragraph (j)(5) of this section, and on foods in small or intermediate-sized VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 packages as provided for in paragraph (j)(13) of this section. In the interest of uniformity of presentation, FDA strongly recommends that the nutrition information be presented using the graphic specifications set forth in appendix B to part 101. * * * * * (ii) * * * (C) At least nine points leading (i.e., space between two lines of text) except that at least 12 points leading shall be utilized for the information required by paragraphs (d)(7) and (d)(8) of this section as shown in paragraph (d)(12), and * * * * * PO 00000 Frm 00093 Fmt 4701 Sfmt 4702 (iii) Information required in paragraphs (d)(7) and (d)(8) of this section shall be in type size no smaller than 8 point, except the type size for this information required in the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section shall be no smaller than 7 point. Information required in the footnote statement shall be no smaller than 7 point, except the type size for this information required in the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section, for the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, and for the simplified format as shown in paragraph (f)(5) of E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11972 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules this section shall be no smaller than 6 point. Information required in paragraph (d)(5) of this section for the ‘‘Calories’’ declaration shall be highlighted in bold or extra bold and shall be in a type size no smaller than 16 point except the type size for this information required in the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section, the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, and the required information shown in paragraphs (d)(11)(iii) and (e)(6)(ii) of this section shall be in a type size no smaller than 12 point. The numeric amount for the information required in paragraph (d)(5) of this section shall also be highlighted in bold or extra bold type and shall be in a type size no smaller than 24 point, except the type size for this information required in the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section, the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, and for the required information shown in paragraph (e)(6)(ii) of this section shall be in a type size no smaller than 20 point. The information required in paragraph (d)(6) of this section shall be in a type size no smaller than 7 point. When provided, the information described in paragraph (d)(10) of this section shall be in a type size no smaller than 6 point. (iv) The headings required by paragraphs (d)(2), (d)(3)(i), and (d)(6) of this section (i.e., ‘‘Nutrition Facts,’’ ‘‘__ servings per container,’’ and ‘‘% DV*’’), the calorie information, and the names of all nutrients that are not indented according to requirements of paragraph (c) of this section (i.e., ‘‘Calories,’’ ‘‘Total Fat,’’ ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total Carbs’’ and ‘‘Protein’’), and the percentage amounts required by paragraph (d)(7)(ii) of this section shall be highlighted in bold or extra bold type or other highlighting (reverse printing is not permitted as a form of highlighting) that prominently distinguishes it from other information. The names of all nutrients that are indented according to the requirements of paragraph (c) of this section (i.e., ‘‘Saturated Fat,’’ ‘‘Trans Fat,’’ ‘‘Dietary Fiber,’’ ‘‘Sugars,’’ and ‘‘Added Sugars’’) and the mandatory and any voluntary vitamins and minerals (except sodium), shall be highlighted in a type that is intermediate between bold or extra bold type and the type for all other information. (v) A hairline rule that is centered between the lines of text shall separate ‘‘Nutrition Facts’’ from the servings per container statement required in VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 paragraph (d)(3)(i) of this section and shall separate each nutrient and its corresponding percent Daily Value required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent Daily Value above and below it, as shown in paragraph (d)(12) of this section. (2) The information shall be presented under the identifying heading of ‘‘Nutrition Facts’’ in the nutrition label and, except for labels presented according to the format provided for in paragraphs (d)(11)(iii), (d)(13)(ii), (e)(6)(ii), (j)(13)(ii)(A)(1), and (j)(13)(ii)(A)(2) of this section, unless impractical, shall be set the full width of the information provided under paragraph (d)(7) of this section, as shown in paragraph (d)(12) of this section. (3) * * * (i) ‘‘llservings per container’’: The number of servings per container, except that this statement is not required on single serving containers as defined in paragraph (b)(6) of this section or on other food containers when this information is stated in the net quantity of contents declaration. The information required in this paragraph shall be highlighted in bold or extra bold and be in a type size no smaller than 11 point except the type size shall be no smaller than 10 point for this information as shown in paragraph (j)(13)(ii)(A)(1) and no smaller than 7 point as shown in paragraph (j)(13)(ii)(A)(2) of this section. This information shall be set the full width of the label as shown in paragraph (d)(12) of this section. (ii) ‘‘Serving size’’: A statement of the serving size as specified in paragraph (b)(7) of this section. The serving size as specified in paragraph (b)(7) of this section must be right justified as shown in paragraph (d)(12) of this section. The information required in this paragraph shall be in a type size no smaller than 8 point except the type size shall be no smaller than 7 point for this information as shown in paragraph (j)(13)(ii)(A)(2) of this section. (4) A subheading ‘‘Amount per’’ followed by the serving size shall be separated from the serving size information by a bar as shown in paragraph (d)(12) of this section and shall be highlighted in a type that is intermediate between bold or extra bold type and the type for all other information, and be in a type size no smaller than 8 point, except the type size for this information required in the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) and the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of PO 00000 Frm 00094 Fmt 4701 Sfmt 4702 this section shall be no smaller than 6 point, and there shall be no bar separating this information from the serving size information in both of these displays for small packages. (5) Information on calories shall immediately follow the heading ‘‘Amount per’’ followed by the serving size and shall be declared in one line. If ‘‘Calories from saturated fat’’ is declared, it shall be indented under ‘‘Calories’’ and shall be in a type size no smaller than 8 point. (6) The column heading ‘‘% DV,’’ followed by an asterisk (e.g., ‘‘% DV*’’), shall be separated from information on calories by a bar as shown in paragraph (d)(12) of this section. The position of this column heading shall allow for a list of nutrient names and amounts as described in paragraph (d)(7) of this section to be to the right of, and below, this column heading, except for labels with a dual or multiple column format as shown in paragraphs (d)(13)(ii), (e)(5), (e)(6)(i), and (e)(6)(ii) the ‘‘% DV’’ column will appear to the right of the list of nutrient names. The column heading described in this paragraph shall not appear on the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section. (7) Except as provided for in paragraphs (d)(13)(ii), (e)(5), (e)(6)(i), (e)(6)(ii), and (j)(13) of this section, nutrient information for both mandatory and any voluntary nutrients listed in paragraph (c) of this section that are to be declared in the nutrition label shall be declared as follows: (i) The name of each nutrient, as specified in paragraph (c) of this section, shall be given in a column and followed immediately by the quantitative amount by weight for that nutrient appended with a ‘‘g’’ for grams, ‘‘mg’’ for milligrams, or ‘‘mcg’’ for micrograms as shown in paragraph (d)(12) of this section. The symbol ‘‘>’’ may be used in place of ‘‘less than.’’ (ii) A listing of the percent of the DRV as established in paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a column aligned under the heading ‘‘% DV’’ established in paragraph (d)(6) of this section with the percent expressed to the nearest whole percent for each nutrient declared in the column described in paragraph (d)(7)(i) of this section for which a DRV has been established, except that the percent for protein may be omitted as provided in paragraph (c)(7) of this section. The percent shall be calculated by dividing either the amount declared on the label for each nutrient or the actual amount of each nutrient (i.e., before rounding) by the DRV for the nutrient, except that the percent for protein shall be E:\FR\FM\03MRP2.SGM 03MRP2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules to accommodate any remaining vitamins and minerals to be declared or the information required in the footnote statement, the remaining information may be moved to the right and set off by a line that distinguishes it and sets it apart from the nutrients and the percent DV information given to the left. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label. (iii) If there is not sufficient continuous vertical space (i.e., approximately 3 in) to accommodate the required components of the nutrition label up to and including the mandatory declaration of potassium, the nutrition label may be presented in a tabular display as shown in the following sample label. mandatory plus voluntary provisions of paragraph (d) of this section. VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00095 Fmt 4701 Sfmt 4702 E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.003</GPH> information by a hairline. This information may be presented horizontally as shown in paragraph (d)(12) of this section (i.e. ‘‘Calories per gram: fat 9, carbohydrate 4, protein 4’’) or vertically in columns. (11)(i) If the space beneath the information on vitamins and minerals is not adequate to accommodate the information required in the footnote statement, the information required in the footnote statement may be moved to the right of the column required in paragraph (d)(7)(ii) of this section and set off by a line that distinguishes it and sets it apart from the percent Daily Value information. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label. (ii) If the space beneath the mandatory declaration of potassium is not adequate (12) The following sample labels illustrate the mandatory provisions and mstockstill on DSK4VPTVN1PROD with PROPOSALS2 calculated as specified in paragraph (c)(7)(ii) of this section. The numerical value shall be followed by the symbol for percent (i.e., %). (8) Nutrient information for vitamins and minerals (except sodium) shall be separated from information on other nutrients by a bar and may be arrayed vertically as shown in paragraph (d)(12) of this section (e.g., Vitamin D 2mcg (10%), Calcium 260mg (20%), Iron 8mg (45%), Potassium 235mg (5%)) or may be listed in two columns. When listed horizontally in two columns, vitamin D and calcium should be listed on the first line and iron and potassium should be listed on the second line. (9) [Reserved] (10) Caloric conversion information on a per gram basis for fat, carbohydrate, and protein may be presented beneath the information required in the footnote statement, separated from that 11973 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 (13) * * * (ii) Aggregate displays shall comply with the format requirements of paragraph (d) of this section to the maximum extent possible, except that VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 the identity of each food shall be specified immediately to the right of the ‘‘Nutrition Facts’’ heading, and both the quantitative amount by weight (i.e., g/ mg/mcg amounts) and the percent Daily PO 00000 Frm 00096 Fmt 4701 Sfmt 4702 Value for each nutrient shall be listed in separate columns under the name of each food. The following sample label illustrates an aggregate display. E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.004</GPH> 11974 * * * * (e) Nutrition information may be presented for two or more forms of the same food (e.g., both ‘‘as purchased’’ and ‘‘as prepared’’) or for common combinations of food as provided for in paragraph (h)(4) of this section, for different units (e.g., slices of bread or per 100 grams) as provided for in paragraph (b) of this section, or for two or more groups for which RDIs are established (e.g., both infants 7 through 12 months and children 1 through 3 years of age) as shown in paragraph (e)(5) of this section. When such dual labeling is provided, equal prominence shall be given to both sets of values. Information shall be presented in a format consistent with paragraph (d) of this section, except that: (1) Following the serving size information there shall be two or more column headings accurately describing the amount per serving size of the form of the same food (e.g., ‘‘Per 1⁄4 cup mix’’ and ‘‘Per prepared portion’’), the combinations of food, the units, or the RDI groups that are being declared as shown in paragraph (e)(5) of this section. (2) The information required in paragraph (d)(7)(ii) and the quantitative information by weight as required in paragraph (d)(7)(i) of this section shall be presented for the form of the product as packaged and for any other form of the product (e.g., ‘‘as prepared’’ or VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 combined with another ingredient as shown in paragraph (e)(5) of this section). (3) When the dual labeling is presented for two or more forms of the same food, for combinations of food, for different units, or for two or more groups for which RDIs are established, the percent DV and quantitative information shall be separated by vertical lines as shown in paragraph (e)(5) of this section. (4) Nutrient information for vitamins and minerals (except sodium) shall be separated from information on other nutrients by a bar and shall be arrayed vertically in the following order: Vitamin D, calcium, iron, potassium as shown in paragraph (e)(5) of this section. (5) The following sample label illustrates the provisions of paragraph (e) of this section: PO 00000 Frm 00097 Fmt 4701 Sfmt 4702 (6) When dual labeling is presented for a food on a per serving basis and per container basis as required in paragraph (b)(12)(i) of this section or on a per serving basis and per unit basis as required in paragraph (b)(2)(i)(D) of this section, the percent Daily Value as required in paragraph (d)(7)(ii) and the quantitative information by weight shall be presented in two columns, and the percent DV and quantitative information shall be separated by vertical lines as E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.006</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 * 11975 EP03MR14.005</GPH> Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 11976 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules (b)(2)(i)(D) and (b)(12)(i) of this section for labels that use the tabular display. added sugars, protein, vitamin D, calcium, iron, and potassium. * * * * * (2) * * * (ii) Any other nutrients identified in paragraph (f) of this section that are present in the food in more than insignificant amounts; and * * * * * (4) If any nutrients are declared as provided in paragraphs (f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the simplified format or if any nutrition claims are made on the label or in labeling, the statement ‘‘Not a significant source of ll_’’ (with the blank filled in with the name(s) of any nutrient(s) identified in paragraph (f) of this section that are present in VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00098 Fmt 4701 Sfmt 4702 insignificant amounts) shall be included at the bottom of the nutrition label. E:\FR\FM\03MRP2.SGM EP03MR14.008</GPH> (f) The declaration of nutrition information may be presented in the simplified format set forth herein when a food product contains insignificant amounts of eight or more of the following: Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, added sugars, protein, vitamin D, calcium, iron, and potassium; except that for foods intended for infants 7 months to 12 months of age and children 1 through 3 years of age to which paragraph (j)(5)(i) of this section applies, nutrition information may be presented in the simplified format when a food product contains insignificant amounts of six or more of the following: Calories, total fat, sodium, total carbohydrate, dietary fiber, sugars, iron, and potassium as shown in the following sample labels. 03MRP2 EP03MR14.007</GPH> information on other nutrients by a bar and shall be arrayed vertically in the following order: Vitamin D, calcium, (ii) The following sample label illustrates the provisions of paragraphs mstockstill on DSK4VPTVN1PROD with PROPOSALS2 shown in the displays in paragraph (e)(6)(i) of this section. (i) Nutrient information for vitamins and minerals shall be separated from (5) Except as provided for in paragraphs (j)(5) and (j)(13) of this section, nutrient information declared in the simplified format shall be presented in the same manner as specified in paragraphs (d) or (e) of this section. (g) Compliance with this section shall be determined as follows: * * * * * (2) The sample for nutrient analysis shall consist of a composite of 12 subsamples (consumer units), taken 1 from each of 12 different randomly chosen shipping cases, to be representative of a lot. Unless a particular method of analysis is specified in paragraph (c) of this section, composites shall be analyzed by appropriate methods as given in the ‘‘Official Methods of Analysis of the AOAC International,’’ 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) or 1 CFR part 51 or, if no AOAC method is available or appropriate, by other reliable and appropriate analytical procedures. The availability of this incorporation by reference is given in paragraph (c)(7) of this section. (3) * * * (ii) Class II. Naturally occurring (indigenous) nutrients. When a nutrient or nutrients are naturally occurring (indigenous) in an ingredient that is added to a food, the total amount of such nutrient(s) in the final food product is subject to class II requirements, except that when a nutrient or nutrients are not naturally occurring (exogenous) in an ingredient that is added to a food, the total amount of such nutrient(s) in the final food product is subject to class I requirements. (4) A food with a label declaration of a vitamin, mineral, protein, total VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 carbohydrate, dietary fiber, soluble fiber, insoluble fiber, polyunsaturated or monounsaturated fat shall be deemed to be misbranded under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the act) unless it meets the following requirements: (i) When a vitamin, mineral, protein, or non-digestible carbohydrate(s) (when the food contains only non-digestible carbohydrates (soluble or insoluble) that meet the definition of dietary fiber) meets the definition of a Class I nutrient, the nutrient content of the composite must be formulated to be at least equal to the value for that nutrient declared on the label. (ii) When a vitamin, mineral, protein, total carbohydrate, polyunsaturated or monounsaturated fat, or non-digestible carbohydrate(s) (when the food contains only non-digestible carbohydrates (soluble or insoluble) that meet the definition of dietary fiber) meets the definition of a Class II nutrient, the nutrient content of the composite must be at least equal to 80 percent of the value for that nutrient declared on the label. No regulatory action will be based on a determination of a nutrient value that falls below this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved. (5) A food with a label declaration of calories, sugars, added sugars (when the only source of sugars in the food is added sugars), total fat, saturated fat, trans fat, cholesterol, or sodium shall be deemed to be misbranded under section 403(a) of the act if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label. No regulatory action will be based on a determination of a nutrient value that falls above this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved. (6) Reasonable excesses of vitamins, minerals, protein, total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugar alcohols, polyunsaturated or monounsaturated fat over labeled amounts are acceptable within current good manufacturing practice. Reasonable deficiencies of calories, sugars, added sugars, total fat, saturated fat, trans fat, cholesterol, or sodium under labeled amounts are acceptable within current good manufacturing practice. (7) Compliance will be based on the metric measure specified in the label statement of the serving size. (8) Alternatively, compliance with the provisions set forth in paragraphs (g)(1) through (g)(6) of this section may be PO 00000 Frm 00099 Fmt 4701 Sfmt 4702 11977 provided by use of an FDA approved database that has been computed following FDA guideline procedures and where food samples have been handled in accordance with current good manufacturing practice to prevent nutrition loss. FDA approval of a database shall not be considered granted until the Center for Food Safety and Applied Nutrition has agreed to all aspects of the database in writing. The approval will be granted where a clear need is presented (e.g., raw produce and seafood). Approvals will be in effect for a limited time, e.g., 10 years, and will be eligible for renewal in the absence of significant changes in agricultural or industry practices. Approval requests shall be submitted in accordance with the provisions of § 10.30 of this chapter. Guidance in the use of databases may be found in the ‘‘FDA Nutrition Labeling Manual—A Guide for Developing and Using Data Bases,’’ available from the Office of Nutrition, Labeling, and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 or by going to https:// www.fda.gov. * * * * * (10) The manufacturer must make and keep written records (e.g., analyses of databases, recipes, formulations, or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows: (i) When a mixture of dietary fiber, and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber, is present in the food, a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber. (ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food, a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber. (iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food, a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber. (iv) When a mixture of naturally occurring and added sugars is present in E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.009</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules the food, a manufacturer must make and keep written records of the amount of added sugars added to the food during the processing of the food, and if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient). (v) When the amount of added sugars added to yeast-leavened bakery products, wines with less than 7 percent alcohol by volume, or beer that does not meet the definition of a ‘‘malt beverage,’’ as defined by the Federal Alcohol Administration Act (27 U.S.C. 211(a)(7)), is reduced through the process of fermentation, manufacturers must: (A) Make and keep records of all relevant scientific data and information relied upon by the manufacturer that demonstrates the amount of added sugars in the food after fermentation and a narrative explaining why the data and information are sufficient to demonstrate the amount of added sugars declared in the finished food, provided the data and information used is specific to the type of fermented food manufactured; or (B) Make and keep records of the amount of added sugars added to the food before and during the processing of the food, and if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient) and in no event shall the amount of added sugars declared exceed the amount of total sugars on the label. (vi) When a mixture of all rac-atocopherol acetate and RRR-atocopherol is present in a food, manufacturers must make and keep written records of the amount of all raca-tocopherol acetate added to the food and RRR-a-tocopherol in the finished food. (vii) When a mixture of folate and folic acid is present in a food, manufacturers must make and keep written records of the amount of folic acid added to the food and folate in the finished food. (11) Records necessary to verify certain nutrient declarations that are specified in paragraph (g)(10) of this section must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce. Such records must be provided to FDA upon request, during an inspection, for official review and photocopying or other means of reproduction. Records required to verify information on the label may be kept VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 either as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records which must be kept in accordance with part 11 of this chapter. These records must be accurate, indelible, and legible. Failure to make and keep the records or provide the records to appropriate regulatory authorities, as required by this subparagraph, would result in the food being misbranded under section 403(a)(1) of the act. (h) * * * (3) * * * (iv) Nutrition information may be provided per serving for individual foods in the package, or, alternatively, as a composite per serving for reasonable categories of foods in the package having similar dietary uses and similar significant nutritional characteristics. Reasonable categories of foods may be used only if accepted by FDA. In determining whether a proposed category is reasonable, FDA will consider whether the values of the characterizing nutrients in the foods proposed to be in the category meet the compliance criteria set forth in paragraphs (g)(3) through (g)(6) of this section. Proposals for such categories may be submitted in writing to the Office of Nutrition, Labeling and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. * * * * * (4) If a food is commonly combined with other ingredients or is cooked or otherwise prepared before eating, and directions for such combination or preparations are provided, another column of figures may be used to declare nutrition information on the basis of the food as consumed in the format required in paragraph (e) of this section; e.g., a dry ready-to-eat cereal may be described with the percent Daily Value and the quantitative amounts for the cereal as sold (e.g., per ounce), and the percent Daily Value and the quantitative amounts for the cereal and milk as suggested in the label (e.g., per ounce of cereal and 1⁄2 cup of vitamin D fortified skim milk); and a cake mix may be labeled with the percent Daily Value and the quantitative amounts for the dry mix (per serving) and the percent Daily Value and the quantitative amounts for the serving of the final cake when prepared, as shown in paragraph PO 00000 Frm 00100 Fmt 4701 Sfmt 4702 (e)(5): Provided, that, the type and quantity of the other ingredients to be added to the product by the user and the specific method of cooking and other preparation shall be specified prominently on the label. * * * * * (j) * * * (5)(i) Foods, other than infant formula, represented or purported to be specifically for infants 7 through 12 months and children 1 through 3 years of age shall bear nutrition labeling. The nutrients declared for infants 7 through 12 months and children 1 through 3 years of age shall include calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, added sugars, protein, and the following vitamins and minerals: Vitamin D, calcium, iron, and potassium. (ii) Foods other than infant formula, represented or purported to be specifically for infants 7 through 12 months of age shall bear nutrition labeling, except that: (A) Such labeling shall not declare a percent Daily Value for saturated fat, trans fat, cholesterol, sodium, dietary fiber, sugars, or added sugars. * * * * * (13) * * * (ii) * * * (A) * * *. (1) The following sample label illustrates the tabular display for small packages. E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.010</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11978 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 11979 VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 § 101.36 Nutrition labeling of dietary supplements. * * * * * (b) * * * (1) Serving size. (i) The subheading ‘‘Serving Size’’ shall be placed under the heading ‘‘Supplement Facts’’ and aligned on the left side of the nutrition label. The subheading ‘‘Servings Per Container’’ and the actual number of servings shall be highlighted in bold or extra bold type. The serving size shall be determined in accordance with §§ 101.9(b) and 101.12(b), table 2. Serving size for dietary supplements shall be expressed using a term that is appropriate for the form of the supplement, such as ‘‘tablets,’’ ‘‘capsules,’’ ‘‘packets,’’ or ‘‘teaspoonfuls.’’ * * * * * (2) * * * (i) The (b)(2)-dietary ingredients to be declared, that is, total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, added sugars, protein, vitamin D, calcium, iron, and potassium, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with § 101.9(c). Calories from saturated fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohol may be declared, but they shall be declared when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in § 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for PO 00000 Frm 00101 Fmt 4701 Sfmt 4702 technological reasons, contain only individual amino acids. * * * * * (B) The names of dietary ingredients that are declared under paragraph (b)(2)(i) of this section shall be presented in a column aligned on the left side of the nutritional label in the order and manner of indentation specified in § 101.9(c), except that calcium and iron shall follow pantothenic acid, and sodium and potassium shall follow chloride. This results in the following order for vitamins and minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folic acid, vitamin B12, biotin, pantothenic acid, calcium, iron, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, potassium, and choline. The (b)(2)-dietary ingredients shall be listed according to the nomenclature specified in § 101.9 or in paragraph (b)(2)(i)(B)(2) of this section. (1) When ‘‘Calories’’ are declared, they shall be listed first in the column of names, beneath a light bar separating the heading ‘‘Amount Per Serving’’ from the list of names. When ‘‘Calories from saturated fat’’ are declared, they shall be indented under ‘‘Calories.’’ (2) The following synonyms may be added in parentheses immediately following the name of these (b)(2)dietary ingredients: Vitamin C (ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin B2), and calories (energy). Energy content per serving may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. (3) Beta-carotene may be declared as the percent of vitamin A that is present as beta-carotene, except that the E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.012</GPH> (B) Using any of the following abbreviations: Serving size—Serv size Servings per container—Servings Calories from saturated fat—Sat fat cal Saturated fat—Sat fat Monounsaturated fat—Monounsat fat Polyunsaturated fat—Polyunsat fat Cholesterol—Cholest Total carbohydrate—Total carbs Dietary fiber—Fiber Soluble fiber—Sol fiber Insoluble fiber—Insol fiber Sugar alcohol—Sugar alc (C) Omitting the footnote statement and placing another asterisk at the bottom of the label followed by the statement ‘‘Percent Daily Values are based on a 2,000 calorie diet.’’ * * * * * (18) * * * (iv) A notice shall be filed with the Office of Nutrition, Labeling, and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 and contain the following information, except that if the person is not an importer and has fewer than 10 full-time equivalent employees, that person does not have to file a notice for any food product with annual sales of fewer than 10,000 total units: * * * * * ■ 3. In § 101.36: ■ a. Revise paragraphs (b)(1)(i), (b)(2)(i) introductory text, (b)(2)(i)(B), (b)(2)(ii)(A), (b)(2)(iii) introductory text, (b)(2)(iii)(D) through (G), (b)(3)(ii)(A), (c)(4), (e) introductory text, (e)(8), (e)(11)(i) through (viii), (e)(12), (f)(2), and (i)(1); and ■ b. Remove paragraph (i) introductory text. The revisions read as follows: EP03MR14.011</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 (2) The following sample label illustrates the linear display. 11980 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 declaration is required when a claim is made about beta-carotene. When declared, the percent shall be declared to the nearest whole percent, immediately adjacent to or beneath the name vitamin A (e.g., ‘‘Vitamin A (90% as beta-carotene)’’). The amount of betacarotene in terms of micrograms (mcg) may be included in the parentheses following the percent statement (e.g., ‘‘Vitamin A (90% (810 mcg) as betacarotene)’’). (ii) * * * (A) The amounts shall be expressed in the increments specified in § 101.9(c)(1) through (c)(7), which includes increments for sodium. * * * * * (iii) The percent of the Daily Value of all dietary ingredients declared under paragraph (b)(2)(i) of this section shall be listed, except that the percent of the Daily Value for protein may be omitted as provided in § 101.9(c)(7); no percent of the Daily Value shall be given for subcomponents for which DRVs or RDIs have not been established (e.g., sugars). * * * * * (D) If the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein, a symbol shall follow the value listed for those nutrients that refers to the same symbol that is placed at the bottom of the nutrition label, below the bar required under paragraph (e)(6) of this section and inside the box, that is followed by the statement ‘‘Percent Daily Values are based on a 2,000 calorie diet.’’ If the product is represented or purported to be for use by children 1 through 3 years of age, and if the percent of Daily Value is declared for total fat, total carbohydrate, dietary fiber, or protein, a symbol shall follow the value listed for those nutrients that refers to the same symbol VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 that is placed at the bottom of the nutrition label, below the bar required under paragraph (e)(6) of this section and inside the box, that is followed by the statement ‘‘Percent Daily Values are based on a 1,000 calorie diet.’’ (E) The percent of Daily Value shall be based on RDI or DRV values for adults and children 4 or more years of age, unless the product is represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, or pregnant and lactating women, in which case the column heading shall clearly state the intended group. If the product is for persons within more than one group, the percent of Daily Value for each group shall be presented in separate columns as shown in paragraph (e)(11)(ii) of this section. (F) For declared subcomponents that have no DRVs or RDIs, a symbol (e.g., an asterisk) shall be placed in the ‘‘Percent Daily Value’’ column that shall refer to the same symbol that is placed at the bottom of the nutrition label, below the last heavy bar and inside the box, and followed by a statement ‘‘Daily Value not established.’’ (G) When calories or calories from saturated fat are declared, the space under the ‘‘% DV’’ column shall be left blank for these items. When there are no other (b)(2)-dietary ingredients listed for which a value must be declared in the ‘‘% DV’’ column, the column may be omitted as shown in paragraph (e)(11)(vii) of this section. When the ‘‘% DV’’ column is not required, but the dietary ingredients listed are subject to paragraph (b)(2)(iii)(F) of this section, the symbol required in that paragraph shall immediately follow the quantitative amount by weight for each dietary ingredient listed under ‘‘Amount Per Serving.’’ (3) * * * PO 00000 Frm 00102 Fmt 4701 Sfmt 4702 (ii) * * * (A) These amounts shall be expressed using metric measures in appropriate units. * * * * * (c) * * * (4) The sample label shown in paragraph (e)(11)(v) of this section illustrates one method of nutrition labeling a proprietary blend of dietary ingredients. * * * * * (e) Except as provided for small and intermediate sized packages under paragraph (i)(2) of this section, information other than the title, headings, and footnotes shall be in uniform type size no smaller than 8 point. A font size at least two points greater shall be used for ‘‘Calories’’ and the heading ‘‘Calories’’ and the actual number of calories per serving shall be highlighted in bold or extra bold type. Type size no smaller than 6 point may be used for column headings (e.g., ‘‘Amount Per Serving’’ and ‘‘% Daily Value’’) and for footnotes (e.g., ‘‘Percent Daily Values are based on a 2,000 calorie diet). * * * * * (8) If the product contains two or more separately packaged dietary supplements that differ from each other (e.g., the product has a packet of supplements to be taken in the morning and a different packet to be taken in the afternoon), the quantitative amounts and percent of Daily Value may be presented as specified in this paragraph in individual nutrition labels or in one aggregate nutrition label as illustrated in paragraph (e)(11)(iii) of this section. * * * * * (11) * * * BILLING CODE 4160–01–P (l) Multiple vitamins E:\FR\FM\03MRP2.SGM 03MRP2 VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00103 Fmt 4701 Sfmt 4725 E:\FR\FM\03MRP2.SGM 03MRP2 11981 EP03MR14.013</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00104 Fmt 4701 Sfmt 4725 E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.014</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11982 VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00105 Fmt 4701 Sfmt 4725 E:\FR\FM\03MRP2.SGM 03MRP2 11983 EP03MR14.015</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00106 Fmt 4701 Sfmt 4725 E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.016</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11984 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 continued to the right as long as the headings are repeated. The list to the right must be set off by a line that distinguishes it and sets it apart from PO 00000 Frm 00107 Fmt 4701 Sfmt 4702 the dietary ingredients and percent of Daily Value information given to the left. The following sample label illustrates this display: E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.017</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 (12) If space is not adequate to list the required information as shown in the sample labels in paragraph (e)(11) of this section, the list may be split and 11985 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules BILLING CODE 4160–01–C (f) * * * (2) When it is not technologically feasible, or some other circumstance makes it impracticable, for firms to VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 comply with the requirements of this section, FDA may permit alternative means of compliance or additional exemptions to deal with the situation in accordance with § 101.9(g)(9). Firms in PO 00000 Frm 00108 Fmt 4701 Sfmt 4702 need of such special allowances shall make their request in writing to the Office of Nutrition, Labeling and Dietary Supplements (HFS–800), Food and Drug E:\FR\FM\03MRP2.SGM 03MRP2 EP03MR14.018</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11986 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. * * * * * (i)(1) Dietary supplements are subject to the special labeling provisions specified in § 101.9(j)(5)(i) for foods VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 other than infant formula, represented or purported to be specifically for infants and children less than 2 years of age. * * * * * PO 00000 Frm 00109 Fmt 4701 Sfmt 9990 11987 Dated: February 24, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–04387 Filed 2–27–14; 8:45 am] BILLING CODE 4160–01–C E:\FR\FM\03MRP2.SGM 03MRP2

Agencies

[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Proposed Rules]
[Pages 11879-11987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04387]

[[Page 11879]]

Vol. 79

Monday,

No. 41

March 3, 2014

Part II

Department of Health and Human Services

-----------------------------------------------------------------------

Food and Drug Administration

-----------------------------------------------------------------------

21 CFR Part 101

Food Labeling: Revision of the Nutrition and Supplement Facts Labels;
Proposed Rule

Federal Register / Vol. 79 , No. 41 / Monday, March 3, 2014 /
Proposed Rules

[[Page 11880]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]
RIN 0910-AF22

Food Labeling: Revision of the Nutrition and Supplement Facts
Labels

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend its labeling regulations for conventional foods and
dietary supplements to provide updated nutrition information on the
label to assist consumers in maintaining healthy dietary practices. The
updated information is consistent with current data on the associations
between nutrients and chronic diseases or health-related conditions,
reflects current public health conditions in the United States, and
corresponds to new information on consumer behavior and consumption
patterns. We are proposing to update the list of nutrients that are
required or permitted to be declared; provide updated Daily Reference
Values and Reference Daily Intake values that are based on current
dietary recommendations from consensus reports; amend requirements for
foods represented or purported to be specifically for children under
the age of 4 years and pregnant and lactating women and establish
nutrient reference values specifically for these population subgroups;
and revise the format and appearance of the Nutrition Facts label.

DATES: Submit either electronic or written comments on the proposed
rule by June 2, 2014. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by April 2, 2014 (see the
``Paperwork Reduction Act of 1995'' section of this document). See
section III of this document for the proposed effective date of a final
rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1210, and/or Regulatory Information Number (RIN) 0910-AF22, by any of
the following methods, except that comments on information collection
issues under the Paperwork Reduction Act of 1995 must be submitted to
the Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section
of this document).

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5360 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-1210 and RIN 0910-AF22 for this rulemaking.
All comments received may be posted without change to https://www.regulations.gov, including any personal information provided. For
additional information on submitting comments, see the ``Comments''
heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-5429, email:
NutritionProgramStaff@fda.hhs.gov.
With regard to the information collection: Domini Bean, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400T, Rockville, MD 20850, Domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

I. Background
A. Legal Authority
B. Need To Update the Nutrition Facts and Supplement Facts
Labels
1. Rates of Chronic Disease
2. Dietary Recommendations, Consensus Reports, and National
Survey Data
3. Consumer Use and Understanding of the Nutrition Facts Label
4. Other Relevant Considerations
5. Citizen Petitions
6. Advance Notices of Proposed Rulemaking (ANPRMs)
7. Impact on Other Regulations
C. Factors for Mandatory or Voluntary Declaration of Non-
Statutory Nutrients
1. Factors Considered
2. Approach for Mandatory Declaration
3. Approach for Voluntary Declaration
II. The Proposed Rule
A. Calories
1. Calories From Fat
2. Calories From Saturated Fat
3. Two Thousand Calories as the Reference Caloric Intake Level
4. Percent DV Declaration for Calories
B. Fat
1. Total Fat
2. Saturated Fat
3. Trans Fat
4. Polyunsaturated Fat
5. Monounsaturated Fat
C. Cholesterol
1. Mandatory Declaration
2. DRV
D. Carbohydrate
1. Total Carbohydrate
2. Sugars
3. Added Sugars
4. Sugar Alcohols
5. Dietary Fiber
6. Other Carbohydrate
E. Protein
1. Mandatory and Voluntary Declaration
2. Analytical Methods
3. DRV
F. Sodium
1. Mandatory Declaration
2. DRV
G. Fluoride
1. Voluntary Declaration
2. DRV
H. Essential Vitamins and Minerals of Public Health Significance
1. Essential Vitamins and Minerals That Are Mandatory
2. Essential Vitamins and Minerals That Are Voluntary
3. Other Essential Vitamins and Minerals
4. Summary
I. Reference Daily Intakes for Vitamins and Minerals
1. Need To Update RDIs
2. Approach To Setting RDIs: EAR Versus RDA
3. Approach To Setting RDIs: Adequate Intake
4. Approach To Setting RDIs: Tolerable Upper Intake Level
5. Approach To Setting RDIs: Population-Weighted Versus
Population-Coverage
6. Declaration of the Absolute Amounts of Vitamins and Minerals
7. Issues Concerning Specific Vitamins and Minerals
J. Units of Measure, Analytical Methods, and Terms for Vitamins
and Minerals
1. Sodium, Potassium, Copper, and Chloride
2. Folate and Folic Acid
3. Vitamins A, D, and E
K. Labeling of Foods for Infants, Young Children, and Pregnant
or Lactating Women
1. Age Range for Infants and Young Children
2. Mandatory Declaration of Calories and Statutorily Required
Nutrients

[[Page 11881]]

3. Declaration of Non-Statutory Nutrients Other Than Essential
Vitamins and Minerals
4. Declaration of Essential Vitamins and Minerals
5. DRVs and RDIs for Infants 7 Through 12 Months of Age
6. DRVs and RDIs for Children 1 Through 3 Years of Age
7. DRVs and RDIs for Pregnant and Lactating Women
L. Dietary Supplements
1. Mandatory Dietary Ingredients
2. Folate and Folic Acid
3. Units of Measure
4. Order of Nutrients Declared on the Label
5. Subpopulations
6. Footnote
M. Format
1. Increasing the Prominence of Calories and Serving Size
2. Changing the Order of the ``Serving Size'' and ``Servings Per
Container'' Declarations and Increasing the Prominence of ``Servings
Per Container''
3. Right-Justifying the Quantitative Amounts Declared in the
``Serving Size''
Statement
4. Changing the ``Amount Per Serving'' Statement
5. Declaration of ``Calories From Fat''
6. Presentation of Percent DVs
7. Placement of ``Added Sugars''
8. Declaration of Absolute Amounts of Vitamins and Minerals
9. Single and Dual Column Labeling
10. The Footnote
11. Use of Highlighting With a Type Intermediate Between Bold or
Extra Bold and Regular Type
12. Addition of Horizontal Line Beneath the Nutrition Facts
Heading
13. Replacing ``Total Carbohydrate'' With ``Total Carbs''
14. Alternative Visual Formats/Fonts
N. Compliance
1. Level of Variance Allowed for the Label Declaration of
Specific Nutrients
2. Methods Used To Determine Compliance
3. Records Requirements
4. Inclusion of Potassium as a Mineral
5. Requirements for Other Carbohydrate, Soluble and Insoluble
Fiber, Added Sugars, and Sugar Alcohols
O. Technical Amendments
1. Changing the Name of the Program Office
2. Changing the Publication Date of Report Incorporated by
Reference
3. Plain Language Edits
III. Proposed Effective and Compliance Dates
IV. Analysis of Impacts
V. Paperwork Reduction Act of 1995
VI. Analysis of Environmental Impact
VII. Federalism
VIII. Comments
IX. References

Executive Summary

Purpose of the Regulatory Action

FDA is proposing to amend the regulations for the nutrition
labeling of conventional foods and dietary supplements to assist
consumers in maintaining healthy dietary practices.
Following the passage of the Nutrition Labeling and Education Act
(NLEA) of 1990 (the 1990 amendments) (Pub. L. 101-535), which added
section 403(q) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 343(q)), we issued various regulations related to
nutrition information on food labels, including the declaration of
nutrients, the format for nutrition labeling, reference values for use
in declaring the nutrient content, and allowances for certain specified
products to be exempt from nutrition labeling (Sec. 101.9 (21 CFR
101.9)). In addition, following the passage of the Dietary Supplement
Health and Education Act (DSHEA) of 1994 (Pub. L. 103-417 and 21 U.S.C.
321(ff)), we amended our food labeling regulations to establish
requirements for nutrition labeling of dietary supplements (Sec. Sec.
101.9(j)(6) and 101.36). Section 403(q) of the FD&C Act specifies
certain nutrients to be declared in nutrition labeling, and authorizes
the Secretary of Health and Human Services to require other nutrients
to be declared if the Secretary determines that a nutrient will provide
information regarding the nutritional value of such food that will
assist consumers in maintaining healthy dietary practices. The
Secretary also has discretion under section 403(q) of the FD&C Act to
remove, by regulation and under certain circumstances, nutrient
information that is otherwise explicitly required in food labeling
under this section.
We are proposing to revise our regulations to provide updated
nutrition information on the label and improve how the nutrition
information is presented to consumers, in light of current scientific
evidence, dietary recommendations of most recent consensus reports, and
public comments received in response to advance notices of proposed
rulemaking. FDA invites comment on its use of the most recent consensus
reports and whether the information and data on which FDA relies from
such reports for proposed changes is consistent with current scientific
information.
Summary of the Major Provisions of the Regulatory Action in Question
We discuss the need to update the Nutrition Facts and Supplement
Facts labels in section I.B., and our scientific considerations for
mandatory and voluntary declaration of nutrients are presented in
section I.C. In sections II.A. through II.K., we discuss provisions
related to the declaration, reference values, analytical methods, and
definitions of nutrients that are required or permitted to be declared
on the Nutrition Facts label of conventional foods, whereas
corresponding changes to the Supplement Facts label of dietary
supplements are presented in section II.L. We present our
considerations related to the format of the Nutrition Facts and
Supplement Facts labels in section II.M., and discuss issues related to
compliance with the proposed requirements in section II.N. Some of the
key proposed actions and considerations of the proposed rule are
highlighted in this document.
Among other amendments related to declaration of nutrients, we are
proposing to remove the declaration of ``Calories from fat'' because
current science supports a view that the type of fat is more relevant
than overall total fat intake in increased risk of chronic diseases. In
addition, removal of the ``calories from fat'' disclosure had no effect
on consumers' judgments of product healthfulness, accuracy in
identifying nutrient contents of products, or perceptions in FDA's
consumer research.
Considering current science and recommendations related to added
sugars, we are also proposing to require the declaration of ``added
sugars,'' that will provide consumers with information they need to
implement the dietary recommendations of the Dietary Guidelines for
Americans, 2010 (2010 DGA).
We are also proposing to update the list of vitamins and minerals
of public health significance. We currently require the mandatory
declaration of percent Daily Values (DVs) of vitamins A and C, calcium
and iron. We analyzed the nutrient inadequacy for vitamins and minerals
based on biomarker data and total dietary intake (conventional foods
and dietary supplements) using National Health and Nutrition
Examination Survey (NHANES) data and other factors for mandatory and
voluntary declaration discussed in section I.C. to determine which
essential vitamins and minerals should be included as nutrients of
public health significance. Based on this analysis, we are not
proposing any changes to the current requirement for mandatory
declaration of calcium and iron. In addition, we are proposing to
require the declaration of vitamin D and potassium, and to permit,
rather than require, the declaration of vitamins A and C.
With respect to reference values used to declare percent DVs of
nutrients, since 1993, new reports from the Institute of Medicine (IOM)
and other consensus and policy reports (for example, the 2010 DGA and
the Report of the Dietary Guidelines Advisory Committee on the Dietary
Guidelines for

[[Page 11882]]

Americans) have been published that update the quantitative intake
recommendations of nutrients as well as their association with chronic
disease and health-related conditions. We are using these new data to
update, as appropriate, the reference values used in the declaration of
percent DVs of nutrients on the Nutrition Facts and Supplement Facts
labels.
Among other amendments to reference values, we are proposing an
updated reference value for the declaration of percent DV for sodium
from the current value of 2,400 mg (milligrams) to 2,300 mg based on a
consideration of current science and IOM's report that set Dietary
Reference Intakes (DRIs) for sodium, including a Tolerable Upper Intake
Level of 2,300 mg/day (d) as a reference intake level not to exceed.
A primary change that we are proposing to the format of the
Nutrition Facts and Supplement Facts labels is to increase the
prominence of the ``Calories,'' numeric value of calories, ``Servings
per container,'' and numeric value of servings per container
declarations. Research suggests that these proposed changes may
increase consumers' attention to the information, and in certain
situations, help consumers to accurately identify the number of
calories in a product. We are also proposing to move the ``% DV'' to
the left side of the label in order to highlight the information for
consumers. We are also proposing to remove the requirement for the
footnote table listing the reference values for certain nutrients for
2,000 and 2,500 calorie diets. We intend to continue to perform
consumer research during this rulemaking process to evaluate how
variations in label format may affect consumer understanding and use of
the Nutrition Facts label. We intend to publish the results of our
research for public review and comment.
[GRAPHIC] [TIFF OMITTED] TP03MR14.001

We are also proposing to require the maintenance of records to
support the declarations of certain nutrients under specified
circumstances. Currently, there are no analytical methods that can
distinguish between dietary fiber (soluble and insoluble fiber) and
non-digestible carbohydrates that do not meet the definition of dietary
fiber; added and naturally occurring sugars; the various forms of
vitamin E; or folate and folic acid and there are no analytical methods
that can determine the amount of added sugar in specific foods
containing added sugars alone or in combination with naturally
occurring sugars, where the added sugars are subject to fermentation.
Therefore, for products that contain non-digestible carbohydrates that
do not meet the definition of dietary fiber, more than one source of
sugar, added sugars that undergo fermentation, various forms of vitamin
E, or folate and folic acid, we are proposing that manufacturers must
make and keep certain written records to verify their declarations of
each of these nutrients in the labeling of the food associated with
such records. We are also proposing that records must be kept for a
period of at least 2 years after introduction or delivery for
introduction of the food into interstate commerce and

[[Page 11883]]

may be kept as original records, as true copies, or electronically, and
manufacturers must provide those records to us for inspection and
copying upon request during an inspection.
We anticipate that consumer education efforts would be needed to
help with consumer understanding and use of information presented under
the changes to the Nutrition Facts and Supplement Facts labels proposed
in this rule. We plan to use the results of our consumer research to
help inform our future actions on this issue.
Finally, we are proposing an effective date of 60 days after the
date of the final rule's publication in the Federal Register with a
compliance date 2 years after the effective date. We invite comment on
the proposed compliance date. In addition to the proposed compliance
date, we invite comment on various other issues, as summarized in
section XI.
Costs and Benefits
We have developed one comprehensive preliminary regulatory impact
analysis that presents the benefits and costs of this proposed rule as
well as the proposed rules entitled Food Labeling: Serving Sizes of
Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual
Column Labeling; Updating, Modifying, and Establishing Certain
Reference Amounts Customarily Consumed; Serving Size for Breath Mints;
and Technical Amendments taken together. The cumulative impact of these
two nutrition labeling proposals, taken as a whole, is shown in the
following table.

Summary of Costs and Benefits
[In billions of 2011 $]
----------------------------------------------------------------------------------------------------------------
Benefits Costs Net benefits
----------------------------------------------------------------------------------------------------------------
Present Value (PV):
3%.................................................... $31.4 $2.3 $29.1
7%.................................................... 21.1 2.3 18.8
Annualized (3% PV Amount)
3%.................................................... 2.0 0.2 1.8
Annualized (7% PV Amount)
7%.................................................... 1.9 0.2 1.7
----------------------------------------------------------------------------------------------------------------
Notes: Compliance period is 24 months. Costs include relabeling and reformulation costs, which are one-time
costs, as well as recordkeeping costs, which recur. Present values of relabeling and reformulation costs are
equivalent at 3 or 7 percent because we conservatively assume that these one-time costs are incurred upon
publication of the rule instead of at the end of the compliance period. Recordkeeping costs, because of their
recurring nature, differ by discount rate; however, such costs comprise a very small percentage of total
costs.

I. Background

The 1990 amendments added section 403(q) to the FD&C Act, which
specifies, in part and with certain exceptions, that food is deemed
misbranded unless its label or labeling bears nutrition information for
certain nutrients. To implement the 1990 amendments, on January 6,
1993, FDA issued several rules, including ``Food Labeling: Mandatory
Status of Nutrition Labeling and Nutrient Content Revision, Format for
Nutrition Label (the 1993 nutrient content final rule)''; ``Food
Labeling; Reference Daily Intakes and Daily Reference Values (1993 RDI/
DRV final rule)''; and ``Food Labeling: Serving Sizes'', to modify how
nutrition information is presented on food labels (58 FR 2079; 58 FR
2206; 58 FR 2229, respectively). FDA published regulations related to:
(1) Declaration of nutrients on food labeling, including nutrients that
are required or permitted to be declared and the format for such
declaration; (2) label reference values for use in declaring the
nutrient content of a food on its label or labeling; (3) two types of
reference values, Reference Daily Intakes (RDIs) for vitamins and
minerals and Daily Reference Values (DRVs) for certain nutrients, which
are used to declare nutrient contents as percent DVs on the Nutrition
Facts label; (4) exemptions for certain specified products; and (5) a
simplified form of nutrition labeling and the circumstances in which
such simplified nutrition labeling can be used. (See Sec. 101.9.)
Elsewhere in this issue of the Federal Register, we are publishing a
proposed rule that will amend the definition of a single-serving
container, require dual column labeling for certain containers, update
the reference amounts customarily consumed and serving sizes for
several food product categories and amend the serving size for breath
mints.
In 1994, DSHEA became law. Among other things, DSHEA amended
section 403(q)(5)(F) of the FD&C Act by adding specific requirements
that relate to the labeling of dietary supplement products.
Accordingly, we amended our food labeling regulations to establish
requirements for nutrition labeling of dietary supplements (Sec. Sec.
101.9(j)(6) and 101.36).
The regulatory history, our rationale for existing requirements,
and FDA activities related to nutrition labeling of foods and dietary
supplements are described in Reference 1.

A. Legal Authority

We are proposing to update the Nutrition Facts label and Supplement
Facts label, as set forth in this proposed rule, consistent with our
authority in section 403(q) of the FD&C Act. Section 403(q)(1) of the
FD&C Act states that a food shall be deemed to be misbranded if, with
certain exceptions, it fails to bear nutrition labeling and identifies
specific nutrient and calorie information required in labeling. Section
403(q)(2)(A) of the FD&C Act provides the Secretary, and by delegation,
FDA, with discretion to require by regulation nutrition information
about nutrients other than those specified in section 403(q)(1) of the
FD&C Act to assist consumers in maintaining healthy dietary practices.
Section 403(q)(2)(B) of the FD&C Act permits the Secretary, and by
delegation, FDA, to remove information relating to a nutrient required
by section 403(q)(1) or 403(q)(2)(A) of the FD&C Act if the Secretary
determines that it is not necessary to assist consumers in maintaining
healthy dietary practices. Consistent with these authorities, we are
proposing to revise certain nutrient declarations in the Nutrition
Facts label and Supplement Facts label. In addition, FDA's authority
includes section 2(b)(1) of the 1990 amendments (21 U.S.C. 343 note).
Specifically, section 2(b)(1)(A) of the 1990 amendments requires
nutrition label information be conveyed in a manner that enables the
public to readily observe and comprehend the information and to
understand its relative significance in the context of a total daily
diet. Such section states that such information should be consistent

[[Page 11884]]

with current scientific knowledge about nutrients and health. We are
proposing changes to DVs (RDIs and DRVs, as applicable) for some
nutrients, which values are used to calculate the percent DV for use on
food labels. The use of reference values based on current science and
the use of such values to calculate the percent DV assists consumers in
comprehending the nutrition information and its relative significance
in a total daily diet. We are also proposing changes to the format
pertaining to information on the percent DV value. Further, section
2(b)(1)(C) of the 1990 amendments stipulates that regulations ``shall
permit the label or labeling of food to include nutrition information
which is in addition to the information required by such section 403(q)
[of the FD&C Act] and which is of the type described in subparagraph
(1)(or (2) of such section . . . .'' We are proposing changes to the
voluntary declaration of certain nutrients in the Nutrition Facts label
consistent with such authority.
Other relevant authorities include sections 701(a), 403(a)(1) and
201(n) of the FD&C Act (21 U.S.C. 371(a), 21 U.S.C. 343(a)(1), and 21
U.S.C. 321(n), respectively). Under section 701(a) of the FD&C Act, the
Agency may issue regulations for the efficient enforcement of the FD&C
Act in order to ``effectuate a congressional objective expressed
elsewhere in the Act'' (Association of American Physicians and
Surgeons, Inc. v FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm.
Mfrs. Ass'n. v FDA, 484 F. Sup. 1179, 1183 (D. Del. 1980).)
We are relying on our authority under sections 403(q), 403(a),
201(n) and 701(a) of the FD&C Act, to propose record requirements to
support nutrient declarations in labeling for added sugars, dietary
fiber, soluble fiber, insoluble fiber, vitamin E, and folate/folic
acid, under certain circumstances, so that we can determine compliance
with labeling requirements and take enforcement action, as needed. For
these nutrients, as explained in section II.N., there is no AOAC
official method of analysis of AOAC International or other reliable or
appropriate analytical procedure, otherwise required by Sec. 101.9(g),
available for FDA to quantify the declared amount of the nutrient,
under certain circumstances. Section 101.9(g) sets forth the standards
for accuracy of the amount statements of nutrients on food labels.
Failing to accurately state the amounts of nutrients on the label under
Sec. 101.9(g) would result in a product being misbranded. Under
section 403(q) of the FD&C Act, a food must bear, in its label or
labeling, the amount of the nutrient the food contains. Moreover, the
nutrient declaration must be truthful and not misleading under sections
403(a)(1) and 201(n) of the FD&C Act. Thus, when a food product
contains dietary fiber (whether soluble, insoluble, or a combination of
both) and added non-digestible carbohydrate(s) that does not meet the
definition of dietary fiber, we are proposing to require manufacturers
to make and keep certain written records to verify the amount of added
non-digestible carbohydrate that does not meet the definition of
dietary. When vitamin E is present in a food as a mixture of all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol, we are proposing
to require manufacturers to make and keep written records to verify the
amount of all rac-[alpha]-tocopherol acetate added to the food and RRR-
[alpha]-tocopherol in the finished food. When a mixture of folate and
folic acid is present in a food, we are proposing to require
manufacturers to make and keep records to verify the amount of folic
acid added to the food and folate in the finished food. When added
sugars as well as naturally occurring sugars are present in a food, we
are proposing to require manufacturers to make and keep records to
verify the declared amount of added sugars in the food. Finally, we are
proposing to require manufacturers to make and keep records to verify
the declared amount of added sugars in specific foods, alone or in
combination with naturally occurring sugars, where the added sugars are
subject to fermentation.
The proposed record requirements for these nutrients, under the
circumstances described, are designed to ensure that the nutrient
declarations are accurate, truthful and not misleading, based on
information known only to the manufacturer, and to facilitate efficient
and effective action to enforce the requirements when necessary. Our
authority to establish records requirements has been upheld under other
provisions of the FD&C Act where FDA has found such records to be
necessary (National Confectioners Assoc. v Califano, 569 F.2d 690, 693-
94 (D.C. Cir. 1978). The records we propose to require are only for
foods for which an adequate analytical method is not available. The
records would allow us to verify the declared amount of each of these
nutrients and that such amount is truthful and not misleading. Thus,
the proposed records requirements would help in the efficient
enforcement of the FD&C Act.
The authority granted to FDA under sections 701(a), 403(q),
403(a)(1) and 201(n) of the FD&C Act not only includes authority to
establish records requirements, but also includes access to such
records. Without such authority, the nutrient declarations for these
specific nutrients that FDA has determined are necessary to assist
consumers in maintaining healthy dietary practices under section
403(q)(2)(A) of the FD&C Act are, practically speaking, not
enforceable. Without access to such records, FDA would not know whether
the amount declared on the label or in the labeling of each these
nutrients, under the circumstances described, is truthful and not
misleading under sections 403(a)(1) and 201(n) of the FD&C Act. The
introduction or delivery for introduction into interstate commerce of a
misbranded food is a prohibited act under section 301(a) of the FD&C
Act (21 U.S.C. 331(a)). Thus, to determine whether the food is
misbranded and the manufacturer has committed a prohibited act, we must
have access to the manufacturer's records that we are requiring be made
and kept under sections 403(q), 403(a)(1), 201(n) and 701(a) of the
FD&C Act. Failure to make and keep records and provide the records to
FDA, as described in proposed Sec. 101.9(g)(10) and (g)(11), would
result in the food being misbranded under sections 403(q) and 403(a)(1)
of the FD&C Act.

B. Need To Update the Nutrition Facts and Supplement Facts Labels

FDA first issued regulations related to the Nutrition Facts label
in 1993. We have not updated the Nutrition Facts label since the 2003
trans fat rulemaking (68 FR 41434; July 11, 2003) or established new or
updated DVs for nutrients since 1995 (60 FR 67164; December 28, 1995).
Since that time, the public health profile of the U.S. population has
changed (e.g., increase in obesity), new information has become
available about nutrient definitions (e.g., vitamin E), reference
intake values, and analytical methods, and new dietary recommendations
(see section I.B.2.) have been published. As a result, we are
reconsidering what nutrients we should require or permit to be listed
on the Nutrition Facts label and what nutrient reference intake values
we should use as a basis for calculating the percent DVs in food
labeling. We also considered corresponding changes to the Supplement
Facts labels. We discuss specific nutrient declarations in greater
detail in section II. Section I.B. includes an overview of information
we considered when forming our tentative conclusions, including
scientific and technical data and recommendations, citizen petitions
submitted to us, and public comments to previous requests

[[Page 11885]]

for comment in advance notices of proposed rulemaking on topics related
to this proposed rule. We also considered the role of nutrition
labeling to assist consumers in maintaining healthy dietary practices
and consumers' use and understanding of the Nutrition Facts label.
1. Rates of Chronic Disease
Chronic diseases, such as heart disease, cancer and stroke are the
leading causes of death and disability in the United States, and
account for 70 percent of all deaths in the United States (Ref. 2). In
2005, 133 million Americans, almost one out of every two adults, had at
least one chronic illness (Ref. 2). An estimated 37 percent of
Americans suffer from cardiovascular disease (CVD) (Ref. 3), 11.3
percent of the population 20 years and older has diabetes, 35 percent
of adults has pre-diabetes (Ref. 4), and 41 percent of the population
is predicted to be diagnosed with cancer during their lifetime (Ref.
5). While the causes of these chronic diseases are multifactorial, poor
diet is a contributing factor associated with morbidity and mortality
(Ref. 6). Many nutrients are associated with chronic disease risk. For
example, diets low in saturated fat and cholesterol, and/or sodium are
associated with a decreased risk of CVD (58 FR 2739; January 6, 1993,
and 58 FR 2820; January 6, 1993). Adequate or increased intake of
calcium and vitamin D may decrease the risk of osteoporosis (73 FR
56477; September 29, 2008).
Obesity rates have increased dramatically over the last three
decades. Between 1976 and 1980 and 2007 and 2008, obesity rates
increased more than twofold (from 15 to 34 percent) in adults and more
than threefold (from 5 to 17 percent) among children and adolescents
(Refs. 6 to 8). Data published by the U.S. Centers for Disease Control
and Prevention (CDC) indicate that 68 percent of adults and about 32
percent of children aged 2 to 19 years in the U.S. population are
overweight or obese (Refs. 7 and 8). Excessive body weight is a risk
factor for chronic diseases such as heart disease, some forms of
cancer, and type II diabetes (Ref. 9). The 2010 DGA affirmed the role
of over consumption of calories and physical inactivity as the primary
risk factors contributing to an epidemic of overweight and obesity in
this country, and urged for a focus on improved nutrition and physical
activity choices among Americans (Ref. 6).
Elevated blood pressure, an important risk factor for CVD (Ref.
10), affects about one-third of the U.S. adult population (Ref. 2).
High intakes of sodium are directly associated with elevated blood
pressure (Ref. 10). Average sodium intake for the U.S. population 4
years of age and older is approximately 3,650 mg/d (Ref. 11). Almost
all Americans consume more sodium than the levels recommended by the
2010 DGA (Ref. 12)
Furthermore, while concerns in recent years have largely shifted
away from nutritional deficiencies, some population subgroups may
consume excess calories but still consume inadequate amounts of certain
micronutrients such as iron, vitamin D, calcium and potassium (see
section II.H.).
The mandatory declaration of nutrients that have public health
significance, the use of updated DVs based on current scientific
evidence, and the use of a format for the Nutrition Facts label to
assist with consumer use and understanding can help consumers make
informed food choices to consume a nutritionally adequate diet while
monitoring calorie intake and lowering their risk of some chronic
diseases.
2. Dietary Recommendations, Consensus Reports, and National Survey Data
a. IOM Dietary Reference Intakes Reports (IOM DRI Reports)--In
1994, the Food and Nutrition Board (FNB) of the Institute of Medicine
(IOM) identified principles for the development of a new set of
reference values that could expand and replace the IOM's Recommended
Dietary Allowances (RDAs) of 1989 (Refs. 13 and 14). A comprehensive
review and application of a growing body of nutritional science
research resulted in the development of a set of reference values,
collectively known as DRIs, published from 1997 to 2010 (Ref. 15). The
DRIs represent a shift in the way that reference values are established
or intended for use. In contrast to previous editions of RDAs (e.g.,
the 1968 and 1989 RDAs), which involved establishing single values for
each nutrient with appropriate adjustments for age, sex and
physiological status, the new DRI framework consisted of four
categories of reference values. These categories include the Estimated
Average Requirement (EAR), RDA, Adequate Intake (AI) and Tolerable
Upper Intake Level (UL). For macronutrients--carbohydrates, fats, and
protein--the IOM developed a new set of reference values called the
Acceptable Macronutrient Distribution Ranges (AMDRs).
The EAR is the average daily nutrient intake level that is
estimated to meet the requirements of half of the healthy individuals
in a particular life stage and gender group. EARs are used for
assessing the statistical probability of adequacy of nutrient intakes
of groups of people. The RDA is an estimate of the average intake level
that meets the nutrient requirements of nearly all (97 to 98 percent)
healthy individuals in a particular life stage and gender group. The
RDA is set using the EAR. In general, the RDA is the EAR plus two times
the standard deviation of the EAR. The RDA is used to plan nutrient
intakes for individuals to ensure a low probability of inadequacy.
Nutrients with EARs and RDAs include carbohydrate, protein, vitamin A,
vitamin C, vitamin E, thiamin, riboflavin, niacin, vitamin
B6, folate, vitamin B12, copper, iodine, iron,
magnesium, phosphorus, selenium, zinc, calcium and vitamin D.
An AI is the level determined for an essential nutrient or a
nutrient that is beneficial for human health when there is insufficient
evidence to calculate an EAR for that nutrient, and therefore
insufficient evidence on which to establish an RDA. AIs can be based on
a variety of data, including scientific evidence about the essentiality
of a nutrient (i.e., choline, biotin, fluoride), experimental data on
risk reduction of chronic disease (i.e., dietary fiber, potassium), and
median intakes of a nutrient using national survey data (i.e., vitamin
K, pantothenic acid, chromium, manganese, linoleic acid, and [alpha]-
linolenic acid). Although there is less certainty about an AI value
than about an RDA value, the AI is similarly designed to cover the
needs of nearly all individuals. The IOM Dietary Planning Report and
Dietary Assessment Report noted that ``the AI should be used with less
confidence if it has not been established as the mean intake of a
healthy group.''
The UL is the highest average daily intake level likely to pose no
risk of adverse health effects for nearly all people in a particular
group. The UL is not intended to be a recommended level of intake. The
UL is used to assess the risk of adverse health effects from excessive
nutrient intake. As intake above the UL increases, so does the
potential for risk of adverse health effects. Nutrients with ULs
include vitamin A, vitamin C, vitamin D, vitamin E, niacin, vitamin
B6, folate, choline, calcium, copper, fluoride, iodine,
iron, magnesium, manganese, molybdenum, phosphorus, selenium, zinc,
sodium, and chloride.
Moreover, while the previous RDAs primarily focused on reducing the
incidence of diseases of nutrient deficiency in the population, the
DRIs

[[Page 11886]]

now take into consideration data on chronic disease risk, such as heart
disease, and developmental abnormalities, such as teratogenicity,
rather than only the signs of deficiency. Finally, where sufficient
data exist, the DRIs take into account the potential benefit or risk to
health of substances that are not essential (such as dietary fiber and
fluoride) that are in addition to the macronutrients of total
carbohydrate, protein, and fat, and the micronutrient vitamins and
minerals permitted or required on the Nutrition Facts label (Ref. 15).
Beginning in 1997, the IOM began publishing its DRIs for those
vitamins, minerals, and macronutrients that are essential in humans or
provide a beneficial role in human health (Refs. 16 to 22). In
addition, the IOM also set AMDRs for carbohydrates, fat, and protein
(Ref. 23). The AMDR for a macronutrient is based on the amount of the
macronutrient that is associated with a reduced risk of chronic disease
while providing adequate intakes of essential nutrients. The AMDR is
expressed as a range of percent energy intake (e.g., 20 to 35 percent
of calories from total fat for adults over 18 years of age). The DRIs
and AMDRs were set for the following life stage groups: Infants (0 to 6
and 7 to 12 months); toddlers (1 to 3 years); boys and girls (4 to 8
years); adolescent boys and girls (9 to 13 and 14 to 18 years); adult
men and women (19 to 30, 31 to 50, 51 to 70, and greater than 70
years); and pregnant and lactating women.
b. IOM Dietary Fiber Report--In 2001, the IOM Panel on the
Definition of Dietary Fiber (the IOM Dietary Fiber Panel) responded to
our request to provide definitions for dietary fiber based on its role
in human physiology and health. The IOM Dietary Fiber Panel developed
two categories of definitions of fiber: ``Dietary Fiber'' and ``Added
Fiber'' in its report Dietary Reference Intakes: Proposed Definition of
Dietary Fiber (the IOM Dietary Fiber Report) (Ref. 24).
c. IOM Dietary Assessment Report--In 2000, the IOM Subcommittee on
Interpretation and Uses of Dietary Reference Intakes (IOM uses
Committee) published the report, DRIs Application in Dietary Assessment
(IOM Dietary Assessment report) on how to use the DRIs for dietary
assessment of individuals and groups.
d. IOM Labeling Report--In 2003, the IOM Committee on nutrition
labeling (IOM Labeling Committee) considered how the DRIs can be used
to develop appropriate reference values for nutrition labeling and
published its report, co-funded by FDA, DRI Guiding Principles for
Nutrition Labeling and Fortification (the IOM Labeling Report) (Ref.
25), with the goal of having an updated nutrition label that consumers
can use to make informed dietary choices.
e. IOM Dietary Planning Report--In 2003, the IOM Subcommittee on
interpretation and uses of DRIs (IOM Uses Committee) published a
report, DRIs Application in Dietary Planning (IOM Dietary Planning
Report) (Ref. 26) on how to use the DRIs for planning intakes of
individuals and groups. This report discusses the use of the DRIs for
food and supplement labels.
f. IOM Sodium Strategies Report--In 2008, the IOM convened a
Committee on Strategies to Reduce Sodium Intake in the United States to
address a Congressional request for recommendations about various means
that could be employed to reduce dietary sodium intake to levels
recommended by the 2005 DGA (less than 2,300 mg/d and no more than
1,500 mg/d for African-Americans, people with hypertension, and middle-
aged and older adults). The Committee's report, Strategies to Reduce
Sodium Intake in the United States (IOM Sodium Strategies Report),
published in 2010, among other strategies, discusses how the labeling
of sodium on foods can serve as a supporting strategy for reducing
sodium intake (Ref. 27).
g. IOM Front-Of-Package Nutrition Rating Systems and Symbols Phase
I and Phase II Reports--In 2010, the IOM Committee on Front-of-Package
(FOP) Nutrition Rating Systems and Symbols reviewed the existing FOP
systems and their underlying nutrition criteria. In the Phase I report,
the IOM identified the nutrients for which there was sufficient
evidence of their role in chronic disease risk and which should be
included in a FOP label (Ref. 28). In 2012, the IOM published its phase
II report that recommended developing a single standardized FOP rating
system and updated their recommendations for nutrients to be included
on the FOP label (Ref. 29).
h. IOM Sodium Intake in Populations Report--In 2012 the IOM
convened a Committee to review and assess the benefits and adverse
outcomes (if any) of reducing the sodium intake in the population,
particularly in the range of 1,500 to 2,300 mg/d. The Committee was
also asked to specifically emphasize relevant subgroups in the analysis
including those 50 years of age and older, African Americans, and those
with diabetes, chronic kidney disease, and congestive heart failure.
The Report was published in May of 2013 and focused its findings and
conclusions on evidence for associations between sodium intake and the
risk of CVD-related events and mortality.
i. Dietary Guidelines for Americans (DGA), 2010--The 2010 DGA,
developed jointly by the U.S. Department of Agriculture (USDA) and the
U.S. Department of Health and Human Services (HHS), provide several key
recommendations including recommendations about dietary patterns, as
well as quantitative intake recommendations with respect to
micronutrients and macronutrients, most of which are based on the IOM
DRI reports (Ref. 6). In a few cases, the 2010 DGA provided
quantitative intake recommendations for certain nutrients (i.e.,
cholesterol and saturated fat) that were not provided by the IOM DRI
reports (Ref. 6). The 2010 DGA emphasized the importance of meeting
food and nutrient recommendations while balancing calorie needs (Ref.
6). More information regarding the scientific basis that informed the
development of the 2010 DGA can be found in the Report of the Dietary
Guidelines Advisory Committee on the Dietary Guidelines for Americans,
2010 (2010 DGAC) (Ref. 30). An important note related to the 2010 DGA
is the specified intended audience for its recommendations (Ref. 6).
From the 1980s until 1995, the DGAs were targeted toward healthy
Americans and designed to provide advice to healthy individuals about
food choices that promote health and prevent disease (Refs. 31 to 34).
In 2000, the recommendations specified an audience of ``healthy
children ages 2 years and older and adults of any age,'' and the 2005
DGA provided recommendations for the ``general public age 2 years and
older.'' (Refs. 35 and 36). While the DGAs have always taken into
account the needs of subpopulations, the most recent 2010 DGA goes
beyond the traditional target of a ``healthy'' audience to provide
chronic disease,'' noting ``the reality that a large percentage of
Americans are overweight or obese and/or at risk of various chronic
diseases'' (Ref. 6).
j. National Health and Nutrition Examination Survey (NHANES)--The
NHANES provides the primary source of information on the health and
nutritional status of adults and children in the United States. The
survey examines a nationally representative sample of about 5,000
persons each year. These persons are located in counties across the
country. The survey combines interviews, which include demographic,
socioeconomic, dietary, and health-related questions, and physical
examinations, which consist of

[[Page 11887]]

medical, dental, and physiological measurements, as well as laboratory
tests administered by highly trained medical personnel (Ref. 37).
3. Consumer Use and Understanding of the Nutrition Facts Label
The Nutrition Facts label is intended to help consumers make
informed food choices and maintain healthy dietary practices. Consumers
became increasingly aware of the new label in the years following
implementation of the 1990 amendments, and reported using food labels
more often in their purchasing decisions compared to their use before
the introduction of the Nutrition Facts label (Ref. 38).
Data from a nationally representative sample of U.S. adults
collected through FDA's Health and Diet Surveys suggest that the
frequency of food label use among consumers progressively increased
between 2002 and 2008 (Refs. 39 to 41). For example, the percentage of
consumers reporting that they ``often'' read a food label the first
time they purchase a food product rose from 44 percent in 2002 to 54
percent in 2008. Among those indicating they read food labels when
purchasing a product for the first time, two-thirds of them in 2008
reported using the label to see how high or low the food was in
calories, salt, vitamins or fat, while more than half said they used
labels to get a general idea of the nutritional content of the product.
A similar increase in reported use of food labels has also been shown
using data from the National Health and Nutrition Examination Surveys
2007-2008 and 2009-1010. The percent of working age adults that
reported using the Nutrition Facts Panel (NFP) always or most of the
time when shopping for food increased to 42% in 2009-2010 from 34% in
2007-2008. Among older adults the percentage increased to 57% in 2009-
2010 from 51% in 2007-2008. (Ref. 42).
Consumer research data suggest that, despite the widespread use of
food labels, certain elements of the Nutrition Facts label may need
improvement. For example, some consumers have difficulty understanding
the concept of percent DV (Refs. 43 and 44) or are confused by the
label footnote that lists DVs for certain nutrients based on a 2,000
and 2,500 calorie diet (Ref. 45).
Section 2(b)(1)(A) of the 1990 amendments mandated that FDA
regulations implementing section 403(q) of the FD&C Act require that
nutrition labeling must be conveyed to the public in a manner which
enables the public to readily observe and comprehend such information
and to understand its relative significance in the context of a total
daily diet. In particular, the percent DV of a nutrient present in food
is declared on food labels to help consumers understand the relative
significance of nutrition information in the context of a total daily
diet, compare the nutritional values of food products, and to plan
general diets (58 FR 2206 at 2213; January 6, 1993). We also noted that
the percent DV information advises the consumer how much of a
recommended intake of that nutrient is provided by the food (58 FR 2079
at 2123; January 6, 1993). We developed the term ``Daily Value'' to
refer to all reference values on the nutrition label (DRVs and RDIs).
We noted that some of the reference values were intended to guide
consumers relative to maximum intakes (DRVs) (e.g., saturated fat),
while others were intended to serve as the basis for planning general
diets to meet nutrient requirements (RDIs) (e.g., vitamin C) (58 FR
2079 at 2124). Our research at the time showed that the term ``Daily
Value'' was generally understood by consumers as a point of reference
(58 FR 2079 at 2125).
In order to determine a nutrition labeling format that could be
used most effectively by consumers, we conducted consumer research and
evaluated research conducted by others in considering requirements for
the nutrition label format (58 FR 2079 at 2115-2121). When available,
we used empirical data on how consumers use and understand the label in
proposing what information should be declared on the label and how. We
used focus group data to inform what we would test in experimental
studies, but did not rely on such data to make policy decisions.
Several comments to the ANPRMs submitted focus group data. However, we
are not relying on focus group data for the proposed changes to the
Nutrition Facts label because focus groups do not yield meaningful
quantitative findings and are not able to support conclusions about the
relationships between the presentation of label information and
consumer responses. As such, they cannot be used to drive the
development of policies, programs, and services. Policy makers and
educators can use focus groups findings to test and refine their ideas,
but should then conduct further research before making important
decisions such as adopting new policies and allocating or redirecting
significant resources to support these policies.
We have completed one study that examined dual-column labels and
ways to increase prominence of certain label information, and intend to
continue to perform research during this rulemaking process to evaluate
how variations in label format may affect consumer understanding and
use of the Nutrition Facts label. Issues to be addressed include how a
declaration of ``Added Sugars'' and alternative footnote statement may
influence consumer use of the label.
The overall goal of these studies is to assess a consumer's ability
to use the Nutrition Facts label and assess a consumer's preferences
related to proposed modifications of the Nutrition Facts label format.
In addition, the studies will help us focus our efforts on consumer
education as well as enhance our understanding of whether modifications
to the Nutrition Facts label format could help consumers make more
informed choices based on their perceptions of the nutritional
attributes and overall healthfulness of a food product. (See also
discussion in section II.M.)
4. Other Relevant Considerations
In developing this proposed rule, we considered changes that would
assist consumers in maintaining healthy dietary practices and recognize
that it is important for the updated Nutrition Facts label to be useful
and relevant to the American population. While the Nutrition Facts
label information has never been nor is it now targeted to individuals
with acute or chronic disease, we are considering the large portion of
the U.S. population that is at risk for chronic disease in proposing
changes to the label's content and format. The population at risk for
chronic disease includes those who are overweight, and therefore at
increased risk of certain chronic diseases, or those who are obese,
leading to a variety of complications including diabetes and CVD. This
approach is consistent with the new IOM DRIs, which are for healthy
individuals, including those at-risk of disease, but not for
individuals with acute or chronic disease or nutrient deficiencies
(Ref. 15). Similarly, the DGAs are for Americans ages 2 years and
older, including those at risk of chronic disease. While consumers with
acute or chronic disease, such as obesity, CVD, or diabetes, may be
able to use quantitative information on the label to follow advice they
have received from a health care professional concerning their
conditions, the nutrient declarations and percent DVs on the label are
to help consumers make more informed choices to consume a healthy diet
and not intended for the clinical management of an existing disease. In
addition, we recognize the importance of federal regulations reflecting
the most current science. In developing this proposed rule, we

[[Page 11888]]

considered new scientific evidence and dietary recommendations about
the relationship between nutrients and health.
Finally, we recognize that the goal of assisting consumers in
maintaining healthy dietary practices requires that we consider certain
practicalities. For example, as we noted in the 1993 nutrient content
final rule (58 FR 2079 at 2107), while the 1990 amendments permit the
Secretary of Health and Human Services to include in the Nutrition
Facts label any information about a nutrient that will assist consumers
in maintaining healthy dietary practices, there is not room on the
label for all information that may be related to maintaining healthy
dietary practices. Space constraints on the label of most foods make
declaring all essential nutrients impractical. In addition, having a
large amount of information on the label could interfere with
consumers' abilities to use the information that has the greatest
public health significance. Therefore, not only are we aware of the
amount and format of mandatory information on the label, but we
recognize that limits to the voluntary information are necessary, so
that voluntary information does not clutter the label, does not
mislead, confuse, or overwhelm the consumer, and does not take away
prominence of and emphasis on the required information.
5. Citizen Petitions
Since 1993, we received a number of citizen petitions requesting
that FDA make various changes to the Nutrition and Supplement Facts
labels. We are addressing a number of issues raised in the following
petitions within this proposed rule: (1) The Calorie Control Council
submitted a citizen petition on April 13, 1995 (Docket No. FDA-1995-P-
0142) requesting that FDA permit the use of the term ``polyols'' in
lieu of sugar alcohols on the Nutrition Facts label (https://www.regulations.gov/#!docketDetail;D=FDA-1995-P-0142); (2) the American
Cocoa Research Institute submitted a citizen petition on April 4, 1996
(Docket No. FDA-1996-P-0035) recommending the accurate communication of
the scientific fact that stearic acid does not affect blood cholesterol
(https://www.regulations.gov/#!docketDetail;D=FDA-1996-P-0035); (3)
Nabisco, Inc. submitted a citizen petition on May 8, 1997 (Docket No.
FDA-1997-P-0476) requesting that FDA amend the definition of ``total
fat'' and ``saturated fat'' in its food labeling regulations to clarify
that acetic, propionic, and butyric acids may be excluded when
calculating the amount of fat in a food product (https://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0476); (4) the Calorie
Control Council submitted a citizen petition on February 13, 1998
(Docket No. FDA-1997-P-0232) requesting that the caloric value of
soluble fiber be no more than 2 kcal/g (https://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0232); (5) the Center for Science in the
Public Interest (CSPI) submitted a citizen petition on August 4, 1999
(Docket No. FDA-1999-P-0158) requesting that FDA establish a DV for
added sugars and require the amount of added sugar, and the percent DV
that represents, to be declared on food labels (https://www.regulations.gov/#!docketDetail;D=FDA-1999-P-0158); (6) Protein
Technologies International, Inc. submitted a citizen petition on
December 21, 2000 (FDA-2000-P-0569) requesting that FDA modify the
reference to the method used to calculate protein content (https://www.regulations.gov/#!docketDetail;D=FDA-2000-P-0569); (7) the National
Starch and Chemical Company (``National Starch'') submitted a citizen
petition on July 8, 2004 (Docket No. FDA-2004-P-0094) requesting that
dietary fiber content be excluded from the ``total carbohydrate''
declaration on the Nutrition Facts label (https://www.regulations.gov/#!docketDetail;D=FDA-2004-P-0094); (8) the Sugar Association submitted
a citizen petition on August 15, 2005 (Docket No. FDA-2005-P-0373)
requesting, in part, that FDA amend regulations related to the labeling
of sugar and alternative sweeteners (https://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0373); (9) CSPI submitted a citizen
petition on November 8, 2005 (Docket No. FDA-2005-P-0196) requesting,
in part, that FDA lower the DV for sodium from 2,400 to 1,500 mg/day
(https://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0196); (10) an
individual submitted a citizen petition on May 25, 2005 (Docket No.
FDA-2005-P-0126) requesting that FDA preclude the declaration of
[beta]-carotene in supplements as vitamin A (https://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0126); (11) an
individual submitted a citizen petition on January 17, 2007 (Docket No.
FDA-2007-P-0404) requesting that FDA amend the definition of trans fat
in its food labeling regulations to express the value of ``zero'' for
trans fat when there are ``absolutely no trans fats at all'' and
require the use of a symbol (e.g., ``~'') to indicate when there is
``more than zero but less than 0.5 grams (g) of trans fat per
tablespoon'' (https://www.regulations.gov/#!docketDetail;D=FDA-2007-P-
0404); and (12) CSPI submitted a citizen petition on February 13, 2013
(Docket No. FDA-2013-P-0217) requesting, in part, that FDA revise the
``Sugars'' line on the Nutrition Facts label to address ``added
sugars'' (https://www.regulations.gov/#!docketDetail;D=FDA-2013-P-0217).
We address the specific requests identified previously for each
citizen petition related to the labeling of conventional foods and
dietary supplements in the appropriate sections in this document.
Requests in these citizen petitions that are unrelated to the content
of the Nutrition Facts label are outside of the scope of this
rulemaking and we will address those requests separately from this
rulemaking.
6. Advance Notices of Proposed Rulemaking (ANPRMs)
We also published three ANPRMs seeking public comment on issues
relevant to updating the Nutrition Facts label.
a. ANPRM on Trans Fat--In the Federal Register of July 11, 2003 (68
FR 41507), we published an ANPRM (the 2003 ANPRM) to solicit
information and data that potentially could be used to establish new
nutrient content claims about trans fatty acids; to establish
qualifying criteria for trans fat in nutrient content claims for
saturated fatty acids and cholesterol, lean and extra lean claims, and
health claims that contain a message about cholesterol-raising lipids;
and, in addition, to establish disclosure and disqualifying criteria to
help consumers make heart-healthy food choices. We also requested
comments on whether we should consider statements about trans fat,
either alone or in combination with saturated fat and cholesterol, as a
footnote in the Nutrition Facts label or as a disclosure statement in
conjunction with claims to enhance consumer understanding about
cholesterol-raising lipids and how to use the information to make
healthy food choices. On March 1, 2004 (69 FR 9559), we reopened the
comment period for the 2003 ANPRM to receive comments that considered
the information in the IOM Labeling Report (Ref. 25) published in the
interim that addressed the labeling of trans fat. On April 19, 2004 (69
FR 20838), we extended the comment period for the 2003 ANPRM to receive
comments that considered the information in the 2004 meeting of the
Nutrition Subcommittee of the Food Advisory Committee (Ref.

[[Page 11889]]

46), which addressed whether the available scientific evidence
supported listing the percent DV for saturated fat and trans fat
together or separately on the Nutrition Facts label and what the
maximal daily intake of trans fat may be.
In response to the 2003 ANPRM, we received about 120 comments. We
consider the comments related to determining a DV for trans fat in
section II.B.3. (see also accompanying Ref. 47). Other issues raised by
comments that are unrelated to the DV for trans fat will be addressed
in a separate rulemaking at a future time.
b. ANPRM on Prominence of Calories--In the Federal Register of
April 4, 2005 (70 FR 17008), we published an ANPRM on the prominence of
calories on the food label (the 2005 ANPRM). The 2005 ANPRM was issued
in response to recommendations from the Obesity Working Group created
by the Commissioner of Food and Drugs to develop an action plan to
address the growing incidence of obesity in the United States. The 2005
ANPRM, in part, requested comments on whether giving more prominence to
the declaration of calories per serving would increase consumer
awareness of the caloric content of the packaged food. We also sought
comment on whether providing a percent DV for total calories would help
consumers understand the caloric content of the packaged food in the
context of a 2,000 calorie diet. In addition, we also requested
comments on questions concerning the declaration of ``Calories from
fat'' (70 FR 17008 at 17010).
We received about 400 comments to the 2005 ANPRM, each containing
one or more issues, from industry, trade associations, consumer groups,
individual consumers, government, and academia. We consider the
comments in sections II.A. and II.M. (see also accompanying Ref. 47).
c. ANPRM on Food Labeling: Revision of Reference Values and
Mandatory Nutrients--In the Federal Register of November 2, 2007 (72 FR
62149), we published an ANPRM regarding the revision of reference
values and mandatory nutrients (the 2007 ANPRM). The 2007 ANPRM
requested comment on various aspects of nutrition labeling, including
what new reference values we should use to calculate the percent DV in
the Nutrition Facts and Supplement Facts labels and what factors we
should consider in establishing such new reference values. In addition,
we requested comments on whether we should require that certain
nutrients be added or removed from the Nutrition Facts and Supplement
Facts labels.
In response to the 2007 ANPRM, we received about 820 comments, from
industry, trade associations, consumer groups, individual consumers,
government, and academia. We consider these comments in each of the
relevant individual nutrient sections in this document (see also
accompanying Ref. 47).
7. Impact on Other Regulations
We recognize that changes to the list of nutrients declared on the
Nutrition Facts label or the RDIs or DRVs of nutrients will likely
affect other FDA regulations, including certain labeling requirements
for foods in 21 CFR part 101. For example, the DVs are used to
determine, in part, whether a food or dietary supplement is eligible to
bear nutrient content claims or health claims (see for example
Sec. Sec. 101.14, 101.54, 101.76, 101.78, and 101.79). In addition,
our fortification policy refers to RDIs and certain DRVs that are
specified in Sec. 101.9 in describing principles for the rational
addition of nutrients to foods (Sec. 104.20 (21 CFR 104.20)). We plan
to evaluate the impact of the proposed changes to the Nutrition Facts
and Supplement Facts labels, if finalized, on other FDA regulations. We
intend to address, as appropriate, the impact on other FDA regulations
in future separate rulemakings. Thus, issues related to nutrient
content claims and health claims are outside the scope of this
rulemaking.

C. Factors for Mandatory or Voluntary Declaration of Non-Statutory
Nutrients

Under section 403(q)(1)(C) and (D) of the FD&C Act, nutrition
information in food labeling must include the total number of calories,
derived from any source and derived from the total fat, and the amounts
of total fat, saturated fat, cholesterol, sodium, total carbohydrates,
complex carbohydrates, sugars, dietary fiber, and total protein. For
purposes of this proposed rule, we consider the nutrients that are
explicitly required by the FD&C Act to be declared on the Nutrition
Facts label as ``statutorily required nutrients.'' Section 403(q)(2)(B)
of the FD&C Act permits the Secretary, and by delegation, FDA, to
remove a statutorily required nutrients from the label or labeling of
food, by regulation, if the Secretary determines the information
related to that nutrient is not necessary to assist consumers in
maintaining healthy dietary practices. FDA regulations require the
declaration of the following statutorily required nutrients: Total
calories, calories from fat, total fat, saturated fat, cholesterol,
sodium, total carbohydrates, sugars, dietary fiber, and total protein
(See Ref. 1 for information on regulatory history). As part of the
effort to update the Nutrition Facts label, we reconsidered the
declaration of these statutorily required nutrients. Our considerations
and tentative conclusions on these nutrients are presented within the
discussion of individual nutrients in section II.
Section 403(q)(2)(A) of the FD&C Act provides that the Secretary
(and by delegation FDA) may, by regulation, require other nutrients to
be declared if the Secretary determines that a nutrient will provide
information regarding the nutritional value of such food that will
assist consumers in maintaining healthy dietary practices. For purposes
of this proposed rule, we consider such nutrients that are not
statutorily required but subject to our discretion under section
403(q)(2)(A) of the FD&C Act, as ``non-statutory nutrients'' to
distinguish such nutrients from those expressly required by the
statute. In the 1993 nutrient content final rule (58 FR 2079), we
considered the existence of a quantitative intake recommendation
highlighted in U.S. consensus reports and the public health
significance of the nutrient in exercising our discretion to determine
which non-statutory nutrients to require or permit on the Nutrition
Facts label. Based on these considerations, with respect to non-
statutory nutrients, we (1) required the declaration of certain
essential vitamins and minerals for which an RDI was established and
that were determined to have public health significance (i.e., vitamins
A and C, iron, and calcium); and (2) permitted the declaration of the
remaining essential vitamins and minerals for which there was an
established RDI or DRV (i.e., vitamin E) or that had public health
significance, as well as permitted the declaration of certain
subcategories of macronutrients for which a DRV was not established
(including monounsaturated fat, polyunsaturated fat, soluble fiber,
insoluble fiber, sugar alcohol, and other carbohydrate) (58 FR 2079).
In this section, we describe our current thinking related to
considerations used to determine whether a non-statutory nutrient
should be required or permitted to be declared on the Nutrition Facts
label. Applying this current thinking, in section II, we are proposing
the mandatory declaration of certain non-statutory nutrients, voluntary
declaration of others, and proposing to remove the mandatory
declaration of another nutrient. For purposes of this proposed rule, we
use the term ``nutrient'' to refer to

[[Page 11890]]

substances that are currently included or that we are considering for
inclusion on the Nutrition Facts label, including carbohydrate, fat,
and protein and their subcomponents (e.g., added sugars, sugar
alcohols, saturated fat), micronutrients (vitamins and minerals), and
to calories, including calories from fat.
1. Factors Considered
We updated the information that we consider for determining whether
the declaration of a non-statutory nutrient should be mandatory or
voluntary. This update responds to several developments. Since the 1993
nutrient content final rule was published, (1) new scientific data have
provided additional evidence of the role of certain nutrients in
chronic disease risk, health-related conditions, or health-related
physiological endpoints and, in some cases, based on the review of this
evidence, DRIs are now available from the IOM that can be used as
quantitative intake recommendations (i.e., RDA and AI), as well as for
assessing the inadequacy and adequacy of essential vitamins and
minerals in the U.S. population (i.e., EAR and AI); (2) the rates of
certain diseases or health-related conditions have either changed or
remained high; and (3) the process for evaluating the relationship
between a nutrient and chronic disease risk, a health-related
condition, or a health-related physiological endpoint has been refined
based on the use of systematic evidence-based reviews for a number of
nutrients (e.g., 2010 DGA, FDA health claims).
We continue to be mindful of past factors we considered as part of
our deliberations related to the Nutrition Facts label, such as the
number of nutrients that could be listed in nutrition labeling, that
some individuals could interpret a long list of nutrients as implying
that a food has greater nutritional significance than is the case, and
that there is limited space for nutrition information on the label (55
FR 29487 at 29493; July 19 1990).
To help us determine whether a non-statutory nutrient should be a
required or permitted declaration, we are considering the same general
types of information used in 1993 when the nutrient content final rule
was published: (1) Existence of quantitative intake recommendations;
and (2) public health significance. We discuss each of these factors in
greater detail in this document.
a. Quantitative Intake Recommendations--Quantitative intake
recommendations are reference intake levels provided in consensus
reports that can be used to set a DRV or RDI. We expect these consensus
reports to be published for the purpose of setting quantitative intake
recommendations (e.g., the IOM DRI reports). If DRIs are not available
for nutrients, other than essential vitamins and minerals, then we
consider science-based recommendations from other U.S. consensus
reports or the DGA policy reports. Such recommendations may be
identified as a conclusion, key recommendation, or reported in the
executive summary of the consensus report.
b. Public Health Significance--For the purposes of nutrition
labeling of foods and dietary supplements, we consider public health
significance to refer to two elements. First we consider whether there
is evidence of a relationship between the nutrient and a chronic
disease, health-related condition, or health-related physiological
endpoint. This can be demonstrated either by well-established evidence
or, for essential vitamins and minerals, recommendations regarding the
health consequences of inadequacy of the nutrient. Second we consider
whether there is evidence of a problem related to health in the general
U.S. population. This needs to be demonstrated by both evidence of a
problem with the intake of the nutrient in the general U.S. population
and evidence of the prevalence of the chronic disease, health-related
condition, or health-related physiological endpoint that is linked to
that nutrient in the general U.S. population. We consider public health
significance to refer to the following: (1) Existence of ``well-
established'' scientific evidence from U.S. consensus reports that
there is a relationship between a nutrient and chronic disease risk, a
health-related condition, or a health-related physiological endpoint
and where the intake of such nutrient is of general importance in the
general U.S. population, e.g., where intakes are generally too low or
too high among the U.S. population. U.S. consensus reports are those
reports that provide consensus conclusions or recommendations by a
group of experts as requested by U.S. Government Agencies (e.g., IOM
reports, the DGAs, National Institutes of Health (NIH) consensus
reports). We generally consider scientific evidence to be ``well-
established'' when such consensus reports have determined the evidence
to be ``conclusive,'' ``documented,'' or ``strong.'' Evidence that
meets the significant scientific agreement standard in section
403(r)(3)(B)(i) of the FD&C Act in support of those nutrients and
disease or health-related conditions for which we have authorized a
health claim would be considered ``well-established'' evidence for the
purposes of what public health significance refers to in this proposed
rule; or (2) nutrients for which there are DRIs set by the IOM (i.e.,
RDA or AI) that are based on chronic disease risk (e.g., osteoporosis),
a health-related condition (e.g., blood pressure) or a nutrient
deficiency with clinical significance (e.g., low iron storage leading
to iron deficiency anemia) for which inadequate intakes of these
nutrients are likely to have important clinical consequences. The
nutrients for which this may occur are essential vitamins and minerals;
and (3) for all nutrients, there is evidence of inadequate or excess
intake of the nutrient based on national nutritional survey data or
U.S. consensus reports, and that a substantial prevalence exists in the
general U.S. population of the chronic disease, health-related
condition, or health-related physiological endpoint that was linked to
the particular nutrient (e.g., soluble fiber and coronary heart disease
(CHD) risk, calcium and risk of osteoporosis). Because we remain
concerned about the large number of nutrients that could be listed as
mandatory or voluntary, for essential vitamins and minerals, we are
proposing for mandatory declaration, those for which inadequacy has the
greatest impact on public health because of their association with a
risk of chronic disease, a health-related condition, or a nutrient
deficiency with clinical significance (e.g., iron deficiency anemia).
The methods used in the evaluation of public health significance of
essential vitamins and minerals are discussed in greater detail in
section II.H. and the accompanying reference document (Ref. 48).
2. Approach for Mandatory Declaration
In general, we continue to consider mandatory declaration
appropriate when there is public health significance and a quantitative
intake recommendation that can be used for setting a DV (DRV or RDI).
However, we have also considered mandatory declaration based, in part,
on evidence highlighting the role of a nutrient in chronic disease
risk. For example, in 2003, we published a final rule requiring trans
fat declaration on the Nutrition Facts label (68 FR 41434). We
considered data and information related to the risk of coronary heart
disease from consumption of trans fat. In addition, we considered the
public health significance of trans fat intake

[[Page 11891]]

based on consensus reports and federal policy statements.
Information related to nutrient intake and its effect on health is
not static. Recommendations from various scientific bodies of the U.S.
Government that are responsible for public health protection or
research directly relating to human nutrition may change or evolve over
time. We include, as part of our review of nutrient information in this
proposed rule, the current recommendations from such scientific bodies.
In section D.3, we specifically consider recommendations from the 2010
DGA related to the intake of added sugars in the diet and the role of
such information in assisting consumers to maintain healthy dietary
practices. Our review is not based on the factors we have traditionally
considered for mandatory declaration that are related to chronic
disease, health-related condition, or health-related physiological
endpoint linked to the particular nutrient. Instead, our review is
based on the need for nutrient information for consumers to implement
key dietary recommendations to assist consumers to maintain healthy
dietary practices and the need for consumers to be able to readily
observe and comprehend the information and to understand its relative
significance in the context of a total daily diet.
3. Approach for Voluntary Declaration
For nutrients that are not essential vitamins and minerals (e.g.,
fluoride, soluble and insoluble fiber, monounsaturated fatty acids and
polyunsaturated fatty acids), we consider voluntary declaration to be
appropriate when the nutrient either has a quantitative intake
recommendation but does not have public health significance, or does
not have a quantitative intake recommendation available for setting a
DRV but has public health significance. In addition, we consider that
voluntary declaration should be permitted for essential vitamins or
minerals that we determine do not fit within our considerations for
mandatory declaration, but that have an RDI.
We invite comment on the factors for considering mandatory and
voluntary declaration of non-statutory nutrients.

II. The Proposed Rule

In this proposed rule, we address issues related to the information
declared on the Nutrition Facts label, i.e., declaration of nutrients,
definitions, analytical methods, RDIs and DRVs, format, and compliance
with declared values. Sections II.A. through II.E. discuss issues
related to calories and macronutrients (including fat, fatty acids,
cholesterol, carbohydrates, sugars, fiber, and protein), whereas
sections II.F. through II.J. discuss issues related to vitamins and
minerals, and sections II.K. and II.L. discuss nutrition labeling
requirements applicable to certain population subgroups and dietary
supplements, respectively. Section II.M. covers issues related to the
format of the Nutrition Facts label, followed by section II.N., which
focuses on provisions related to compliance and verification. Finally,
section II.O. describes technical amendments to existing provisions in
Sec. 101.9.
As discussed in this document, our evaluation of these issues was
informed by current scientific evidence, dietary recommendations, and
conclusions of current consensus reports. We took into account any
related requests from petitioners and public comments.

A. Calories

Section 403(q)(1)(C) of the FD&C Act requires the declaration of
the total number of calories derived from any source. Correspondingly,
FDA regulations require the total caloric content of a food to be
declared on the Nutrition Facts label (Sec. 101.9(c)(1)). We are not
proposing to modify the requirement to declare total calories. However,
we are reconsidering a number of other requirements related to the
declaration of information about calories. The requirements related to
``Calories from fat,'' ``Calories from saturated fat,'' the 2,000
reference calorie intake level, and a percent DV for calories are
discussed in section II.A., whereas requirements related to prominence
of the calorie declaration and the footnote statement and table of DVs
for 2,000 and 2,500 calorie diets are discussed in section II.M.
1. Calories From Fat
The declaration of ``Calories from fat'' is mandatory (Sec.
101.9(c)(1)(ii)). Section 403(q)(1)(C)(ii) of the FD&C Act requires
total calories from fat to be declared on the label or labeling of
food. Section 403(q)(2)(B) of the FD&C Act provides the Secretary of
Health and Human Services (and by delegation, FDA) with discretion to
remove the requirement by regulation if the Secretary determines that
it is not necessary to assist consumers in maintaining healthy dietary
practices. We reviewed current scientific evidence and recommendations
in current consensus reports in determining whether information on
calories from fat is necessary to assist consumers in maintaining
healthy dietary practices. We also considered comments (Ref. 47) to the
2005 and 2007 ANPRMs, in which we requested comment on various
questions related to ``Calories from fat'' declared on the Nutrition
Facts label. Unlike dietary recommendations that we relied on during
the 1993 rulemaking, current dietary recommendations no longer
emphasize total fat. Certain fatty acids are understood to be
beneficial, while others are understood to have negative health
effects, particularly related to cardiovascular disease (Refs. 6, 36,
and 49). Accordingly, the 2005 DGA shifted its focus from total fat
reduction to reduction in certain types of fatty acids and their
influence on the risk of cardiovascular disease (Ref. 36). The 2002 IOM
Macronutrient Report (Ref. 49) set an AMDR for total fat at 20 to 35
percent of calories, recognizing that there were some benefits to
consuming moderate amounts of fat (Ref. 49). The 2002 IOM Macronutrient
Report and the 2010 DGA (Refs. 6 and 49) concluded that the type of fat
consumed was more relevant in reducing the risk of CHD than overall
total fat intake.
Based on the these dietary recommendations and consensus reports
that emphasize intake of total calories and the type of fat consumed,
as well as comments to the 2005 and 2007 ANPRMs that supported
eliminating the declaration of ``Calories from fat'' in order to place
greater emphasis on total calories (Ref. 47), we tentatively conclude
that declaration of ``Calories from fat'' is not necessary to assist
consumers in maintaining healthy dietary practices. Therefore, we are
proposing to no longer require, and to not allow voluntarily, the
declaration of ``Calories from fat'' on the Nutrition Facts label.
While eliminating the declaration of ``Calories from fat'' may appear
to be a loss of information on the amount of fat being consumed, as
some comments suggested, the amount of fat being consumed can still be
obtained from the total fat declaration elsewhere on the Nutrition
Facts label, and consumers can still use the percent DV for total fat
to put fat content in the context of a total daily diet, compare
products, and plan diets. Therefore, we are proposing to remove current
Sec. 101.9(c)(1)(ii) to remove the requirement for declaration of
calories from fat (and redesignate Sec. 101.9(c)(1)(iii) as proposed
Sec. 101.9(c)(1)(ii)). We invite comment on the tentative conclusion
to no longer require, and to not allow voluntarily the declaration of
``Calories from fat'' on the Nutrition Facts label.

[[Page 11892]]

2. Calories From Saturated Fat
The declaration of ``Calories from saturated fat'' is voluntary
(Sec. 101.9(c)(1)(iii)). The 2010 DGA continues to recommend that
Americans should consume less than 10 percent of calories from
saturated fat (Ref. 6). Saturated fat is known to increase the risk of
cardiovascular disease and, unlike ``Calories from fat,'' which could
include calories attributable to fatty acids that decrease or increase
the risk of certain diseases, ``Calories from saturated fat'' would
provide information about calories from a source known to increase
disease risk (Ref. 49). We considered the recommendations in current
consensus reports as well as the comments (Ref. 47) received in
response to the 2007 ANPRM requesting comment on whether the
declaration of ``Calories from saturated fat'' should continue to be
voluntary or whether it should be mandatory.
Based on the recommendations in current consensus reports and
supported by many comments, we tentatively conclude that mandatory
declaration of ``Calories from saturated fat'' is not necessary because
the amount of saturated fat being consumed can still be obtained from
the total saturated fat declaration elsewhere on the Nutrition Facts
label. Additionally, as with total fat, consumers can still use the
percent DV for saturated fat to put saturated fat content in the
context of a total daily diet, compare products, and plan diets.
However, because there is strong evidence associating higher intakes of
saturated fat with higher low-density lipoprotein (LDL) cholesterol
levels, information on ``Calories from saturated fat'' can assist
consumers in maintaining healthy dietary practices. Therefore, we are
not proposing to change the current voluntary labeling of ``Calories
from saturated fat'' in the Nutrition Facts label as specified in Sec.
101.9(c)(1)(iii). However, considering our proposal to eliminate the
declaration of ``Calories from fat'' on the Nutrition Facts label (see
section II.A.1.), we are proposing to revise Sec. 101.9(c)(1)(iii) and
(d)(5) to specify that the statement ``Calories from saturated fat,''
when declared, must be indented under the statement of calories. In
addition, we are proposing to redesignate Sec. 101.9(c)(1)(iii) as
proposed Sec. 101.9(c)(1)(ii).
3. Two Thousand Calories as the Reference Caloric Intake Level
Per FDA regulations, a reference calorie intake level of 2,000
calories is used to set DRVs for total fat, saturated fat, total
carbohydrate, protein, and dietary fiber (Sec. 101.9(c)(9)). In
addition, we require a footnote on the Nutrition Facts label that
states, ``Percent Daily Values are based on a 2,000 calorie diet. Your
daily values may be higher or lower depending on your calorie needs,''
followed by a table with certain DVs based on 2,000 and 2,500 calorie
diets (Sec. 101.9(c)(9)). In reconsidering the 2,000 calories
reference intake level, we considered relevant recommendations from the
IOM macronutrient report that provided estimated energy requirements
(EERs) and the IOM Labeling Report (Refs. 25 and 50). We also
considered comments (Ref. 47) received in response to the 2007 ANPRM,
in which we asked whether 2,000 calories should continue to be used as
the reference calorie intake level and asked questions related to the
use of the EERs.
An EER is a DRI set by the IOM for energy intake and is defined as
the dietary energy intake that is predicted to maintain energy balance
in a healthy adult of defined age, gender, weight, height, and level of
physical activity consistent with good health. The IOM set EERs for all
life-stage and gender groups and based these EERs on normal weight
individuals (i.e., BMI < 25) (Ref. 50). The IOM Labeling Committee
considered whether there was a basis to use the EERs for developing a
new reference calorie intake level for macronutrients in nutrition
labeling. The IOM Labeling Committee noted that using the EER to derive
a reference calorie intake level would require making assumptions about
height, weight, and physical activity level. Furthermore, the equations
used to calculate the EERs were based on normal weight individuals;
however, the American population has a high prevalence of overweight
and obesity. Thus, the IOM Labeling Committee found that the data
necessary to use the EER concept as the basis for a reference calorie
intake level for nutrition labeling were incomplete and it could not
recommend the approach (Ref. 25). The IOM Labeling Committee concluded
that retaining the current 2,000 reference calorie intake level would
be the best approach as it would provide continuity and would not
encourage higher calorie intake and overconsumption of energy (Ref.
25).
We agree with the IOM Labeling Report and comments in response to
the 2007 ANPRM (Ref. 47) that the EERs do not provide an appropriate
basis for the derivation of a reference calorie intake level for the
purpose of nutrition labeling. The EERs are influenced by various
parameters such as age, gender, height, weight, and physical activity
level (PAL), which makes it challenging to combine the EERs into a
single reference calorie intake level applicable to the general
population. Further, all of the comments supported the use of the 2,000
calorie reference intake level.
Therefore, we are not proposing any changes to the current use of
2,000 reference calorie intake level as the basis for setting DRVs for
total fat, saturated fat, total carbohydrate, dietary fiber, and
protein, as specified in Sec. 101.9(c)(9).
4. Percent DV Declaration for Calories
Current regulations do not provide for a DRV for calories. Setting
a DRV for calories would necessitate the determination of a
quantitative intake recommendation for calories. To determine an
appropriate DRV for calories, we reviewed recommendations in current
consensus reports. We also considered comments (Ref. 47) received in
response to the 2005 and 2007 ANPRMs, in which we asked whether
providing a percent DV disclosure for total calories would assist
consumers in understanding the caloric content of the packaged food in
the context of a 2,000 calorie diet. The IOM macronutrient report is
the most recent consensus report that provides quantitative intake
recommendations for calories (Ref. 50), and those quantitative intake
recommendations are the EERs. For the same reasons that EERs are not
appropriate for setting the reference calorie intake level as described
previously, these EERs are not appropriate for setting a DV for
calories. First, the EERs do not apply to overweight individuals, and
are therefore not applicable to a substantial portion of the general
population. Second, combining the EERs into a single, meaningful
reference value is challenging because they vary by age, gender,
height, weight, and PAL. In addition, DRVs were established for those
nutrients that are important in diet and health interrelationships and/
or based on caloric intake (55 FR 29476 at 29479; July 19, 1990).
Accordingly, most of the DRVs have been based on quantitative intake
recommendations associated with chronic disease risk or a health-
related condition (e.g., total fat, saturated fat, cholesterol, and
dietary fiber). In contrast, the EERs are neither associated with
chronic disease risk or a health-related condition, nor are they
intended to be treated as a single recommended value that can be
applied to the general U.S. population. Thus, we tentatively conclude
that there is no appropriate quantitative intake recommendation and we
are not aware of any other data or information on which a DRV for
calories can be determined. Although a majority of

[[Page 11893]]

comments to the ANPRMs supported the addition of a percent DV for total
calories, we are not persuaded to propose to require or permit such
declaration due to the lack of an appropriate quantitative intake
recommendation or other data or information on which FDA could rely to
establish a DRV for calories. We invite comment on the tentative
conclusion not to establish a DRV for calories and include a percent DV
for the declaration of calories.
Therefore, we are not proposing to set a DRV for calories and, as a
result, a percent DV declaration for calories would be neither required
nor permitted.

B. Fat

In section II.B., we discuss considerations related to definitions,
declaration, and DRVs for total fat, saturated fat, trans fat,
monounsaturated fat, and polyunsaturated fat.
1. Total Fat
a. Definition--FDA defines ``fat, total'' or ``total fat'' in Sec.
101.9(c)(2) as a statement of the number of g of total fat in a serving
defined as total lipid fatty acids and expressed as triglycerides.
In 1997, we received a citizen petition from Nabisco, Inc. (Docket
No. FDA-1997-P-0476) requesting that FDA amend the definitions of
``total fat'' and ``saturated fat'' in its food labeling regulations to
clarify that acetic, propionic, and butyric acids may be excluded when
calculating the amount of fat in a food product (https://www.regulations.gov/# !docketDetail;D=FDA-1997-P-0476). The
petitioner's requests related to the definition and labeling of total
fat are presented here and the petitioner's requests related to the
definition of saturated fat are discussed in section II.B.2.
With respect to total fat, the petitioner requested that we amend
Sec. 101.9(c)(2) to read as follows: ``Fat, total'' or ``Total fat'':
A statement of the number of g of total fat in a serving defined as
total lipid fatty acids, excluding acetic (C:2), propionic (C:3), and
butyric (C:4) acids and expressed as triglycerides . . .'' The
petitioner stated that acetic, propionic, and butyric acids (``the
acids''), which have very short two, three, and four carbon chains,
respectively, are organic acids that should not be considered fatty
acids for food labeling purposes for the following reasons: (1) The
acids are chemically different from fatty acids because they are water
soluble; (2) the digestion and absorption of the acids are distinctly
different from those of fatty acids; (3) the acids are metabolized
differently than fatty acids and are biochemically and physiologically
more closely related to carbohydrates than to fat; and (4) the acids do
not cause the adverse health effects associated with fat and may even
have benefits that make them distinct from fat. The petitioner noted
that excluding the acids from the definition of fat would not affect
current labeling practices because they are found in such small amounts
in the food supply. In addition, the petitioner asserted that
analytical methods would not be affected because approved AOAC methods
for total fat measurement do not detect the acids.
We disagree with the petitioner that the acids are chemically
different from fatty acids because they are water soluble and that
insolubility in water is the essential chemical property of a fat.
Fatty acids are monocarbonic acids with chain lengths between 1 and
nearly 30 carbon atoms (Ref. 51). The chain length of a fatty acid
determines its physical properties (Ref. 51). Short-chain fatty acids
are compounds that are soluble in water. As the chain length increases,
water-solubility decreases (Ref. 51). Short chain acids such as acetic,
propionic, and butyric acids are still considered fatty acids although
they are water soluble. Furthermore, the characteristic feature of a
fatty acid is a terminal carboxyl group attached to a chain of alkyl
groups containing carbon atoms of which these short chain acids are
composed (Ref. 52).
We determine the amount of the major macronutrients (carbohydrate,
fat, and protein) in a food product by their chemical composition. We
tentatively conclude that the petitioner did not provide a scientific
basis on which we could rely to propose to exclude acetic, propionic,
and butyric acids from the definition of total fat based on differences
in chemical composition. Moreover, the petitioner did not explain why
we should define total fat based on physiological differences
identified for such fatty acids compared to other fatty acids, even if
true, and not retain our current approach to define total fat based on
chemical composition. Therefore, we are not proposing any changes to
the current definition of ``total fat.'' We request comment on our
tentative conclusion that acetic, propionic, and butyric acids should
not be excluded from the definition of ``total fat.''
To clarify what we consider to be a fatty acid, we are proposing to
define ``fatty acids'' in Sec. 101.9(c)(2) as ``aliphatic carboxylic
acids consisting of a chain of akyl groups and characterized by a
terminal carboxyl group.'' This definition is consistent with other
similar definitions found in nutrition and chemistry references (Refs.
51 to 54). We request comment on the proposed definition of fatty
acids.
b. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act
requires the declaration of the amount of total fat on food labels.
Consequently, the Nutrition Facts label includes the mandatory
declaration of the gram amount for total fat in Sec. 101.9(c)(2).
The 2010 DGA recognizes that the types of fatty acids consumed are
more important in influencing the risk of CVD than the total amount of
fat in the diet (Ref. 6). Current dietary recommendations and clinical
guidelines encourage replacing saturated and trans fatty acids with
beneficial fats, such as polyunsaturated and monounsaturated fatty
acids (Refs. 6 and 55). A high intake of most types of saturated fatty
acids, trans fatty acids, and cholesterol can increase LDL cholesterol
levels, which in turn may increase the risk of CHD (Ref. 49). While
there is a significant amount of evidence showing that a diet high in
saturated or trans fatty acids may be detrimental to health, there is
also evidence that consumption of less than 20 percent of calories from
fat can lead to an increased risk of insufficient intake of vitamin E
and essential fatty acids (Ref. 49). In addition, consumption of a low
fat diet that is high in carbohydrate can lead to a reduction in high
density lipoprotein cholesterol concentration and an increase in blood
triglycerides, which can result in an increased risk of CHD (Ref. 49).
We concur with the 2010 DGA that consuming a diet low in saturated
fatty acids and cholesterol is more important for reducing CVD risk
than consuming a diet low in total fat. This finding is consistent with
the conclusions in the IOM Macronutrient Report (Ref. 49), as well as
with current practice guidelines such as the National Heart, Lung, and
Blood Institute (NHLBI) Third Report of the Expert Panel on Detection,
Evaluation, and Treatment of High Blood Cholesterol in Adults (Ref.
55). Total fat is a calorie-yielding macronutrient and an important
piece of the macronutrient profile of a food. However, consumption of
inadequate amounts of total fat is also associated with an increased
risk of impaired growth and consumption of excessive amounts of total
fat is associated with an increased risk of chronic diseases, such as
CHD and diabetes (Ref. 49). In addition, the IOM noted that high fat
diets are usually accompanied by increased intakes of saturated fatty
acids which can increase the risk of CHD (Ref. 49). Thus, we
tentatively conclude that

[[Page 11894]]

mandatory declaration of total fat on the Nutrition Facts label
continues to be necessary to assist consumers in maintaining healthy
dietary practices. Therefore, we are not proposing any changes to the
current requirement for mandatory declaration of total fat on the
Nutrition Facts label.
c. DRV--The DRV for total fat is 30 percent of calories (65 g/d)
(Sec. 101.9 (c)(9)). In developing the DRIs for various nutrients, the
IOM cited a lack of data sufficient to determine a defined level of fat
intake at which no risk of inadequacy or prevention of chronic disease
occurs, and therefore, decided to establish neither an AI nor an RDA
for total fat (Ref. 49). Instead, the IOM established an AMDR for total
fat intake of 20 to 35 percent of energy for adults and an AMDR of 25
to 35 percent of energy for children age 4 to 18 years. The AMDRs are
associated with reduced risk of chronic diseases, such as CHD, while
providing for adequate intake of essential nutrients. The 2010 DGA
acknowledged the IOM's AMDR and noted that total fat intake should fall
within the AMDRs set by the IOM (Ref. 6). The IOM Labeling Committee
recommended that AMDRs should be the basis for DVs for protein, total
carbohydrate, and total fat (72 FR 62149 at 62164). Accordingly, for
total fat, the IOM Labeling Committee recommended a population-weighted
midpoint of the AMDR since AMDRs vary with age. A population-weighted
mid-point of the AMDR for adults, i.e., 20 to 35 percent, yields a DRV
of 28 percent or 62 g of total fat. The use of the upper level (35
percent of energy) of the AMDR would increase the DRV from 65 g to 78 g
for a 2,000 calorie diet.
Considering the recommendations of the IOM Labeling Committee, we
requested comment, in the 2007 ANPRM, on: (1) Whether a population-
weighted midpoint of the AMDR (e.g., 28 percent for adults) should be
used, as suggested in the IOM Labeling Report and (2) whether the upper
level of AMDR of 35 percent (78 g) should be used.
We reviewed the IOM Labeling Committee's recommendations, IOM DRIs,
and comments in response to the 2007 ANPRM (Ref. 47). We tentatively
conclude that changing the DRV for total fat to the lower end of 20
percent of 2,000 calories would not be appropriate because: (1) It
would not be appropriate for children 4 to 18 years of age because it
falls below the lower end of the AMDR (i.e., 25 to 35 percent of
energy) and (2) scientific evidence supports consumption of greater
than 20 percent of total calories from total fat for reduction in risk
of chronic diseases, such as CHD and diabetes (Ref. 49).
We also conclude that the upper level of the AMDR of 35 percent of
2,000 calories as the basis for a DRV would provide no meaningful
health benefit and that a population-weighted mid-point of 28 percent
of the AMDR (28 percent of calories) as the basis for the DRV is not
significantly different from a public health outcome standpoint than
the current value of 30 percent of calories. Using the population-
weighted AMDR midpoint approach would result in an insignificant
reduction from the DRV of 65 g (rounded from 30 percent of a 2,000
calorie diet) to 60 g (rounded from 28 percent of calories), which may
imply a greater level of precision in a DRV than is actually true.
Furthermore, the DRV for total fat is linked to the DRVs for total
carbohydrate and protein. For reasons discussed in sections II.D. and
II.E., we are not proposing to change the DRVs for carbohydrate or
protein at this time. Because the DRV for carbohydrate is determined by
difference, an increase in the DRV for fat would result in a decrease
in the DRV for carbohydrate.
The DRV of 30 percent of calories fits within the AMDR and
represents a moderate value that is not close to the upper or lower
levels of the AMDR. A majority of comments supported maintaining the
current DRV of 30 percent of calories. As noted previously, the DRV for
total fat was calculated based on a 2,000 reference calorie intake and
the dietary recommendation for fat intake at the time of 30 percent or
less of total caloric intake, amounting to 66.7 g of fat, which was
rounded down to 65 g. Current dietary recommendations for fat intake
provide a range of acceptable intakes (i.e., between 20 and 35 percent
of caloric intake) and encompass the 30 percent value that formed the
basis for the existing DRV. Therefore, we are not proposing any changes
to the current DRV for total fat of 30 percent of calories.
2. Saturated Fat
a. Definition--FDA regulations define ``Saturated fat'' in Sec.
101.9(c)(2)(i) as the sum of all fatty acids containing no double
bonds. We received a citizen petition from the American Cocoa Research
Institute on April 3, 1996 (Docket No. FDA-1996-P-0035) requesting that
the Agency exclude stearic acid from the definition of saturated fat
because the petitioner claimed that stearic acid does not raise LDL-
cholesterol levels or the risk of CHD (https://www.regulations.gov/#
!docketDetail;D=FDA-1996-P-0035). In the 2007 ANPRM, we did not seek
comments on the definition of saturated fat, but received a few
comments that requested excluding stearic acid from the definition of
saturated fat or permitting a separate listing for stearic acid below
the line for saturated fat (Ref. 47).
We considered the comments to the 2007 ANPRM and the request by the
American Cocoa Research Institute petition, and do not agree that
stearic acid should be excluded from the definition of saturated fat.
While there is evidence that there are potential differences in the
physiological effects of different saturated fatty acids, including on
LDL cholesterol levels, the definitions of nutrients for food labeling
purposes have traditionally been based on chemical definitions, rather
than on individual physiological effects. The definition for saturated
fat in Sec. 101.9(c)(2)(i) includes all fatty acids without double
bonds and the accepted analytical methods capture all of the saturated
fatty acids, including stearic acid. In adopting this definition, we
addressed the issue of inclusion/exclusion of individual saturated
fatty acids and determined that a chemical definition (which includes
all fatty acids containing no double bonds) was the appropriate
approach to define saturated fat (58 FR 2079 at 2088). We further note
that the 2010 DGA recommendation related to saturated fat intake is
based on scientific evidence related to the intake of all saturated
fatty acids combined, which includes stearic acid. The DGA
recommendation to consume less than 10 percent of calories from
saturated fatty acids makes no specific exclusion of stearic acid and,
instead, relates to the intake of total saturated fatty acids (Ref. 6).
There are no quantitative intake recommendations for stearic acid.
The inclusion of stearic acid in the definition of saturated fat is
consistent with our overall approach to rely on chemical definitions of
nutrients as the basis for regulatory definitions for food labeling
purposes. The American Cocoa Research Institute petition did not
provide a basis for why we should deviate from this overall approach to
rely on the chemical definition of nutrient as a basis for a regulatory
definition. Thus, we are not proposing to exclude stearic acid from the
definition of saturated fat.
Finally, we also considered voluntary declaration of stearic acid
on the Nutrition Facts label, as recommended by a few comments. The
effects of stearic acid on LDL cholesterol levels appear to vary
depending on the macronutrient component that is replaced by stearic
acid (Ref. 30).

[[Page 11895]]

Moderate evidence indicates that when stearic acid substitutes for
other saturated fatty acids or trans fat, plasma LDL cholesterol levels
decrease whereas when it replaces monounsaturated or polyunsaturated
fatty acids, LDL cholesterol levels increase (Ref. 30). Considering
such scientific data, the 2010 DGAC concluded that the potential
effects of changes in dietary intake of stearic acid on the risk of CVD
remain unclear. Thus, the evidence for a role of stearic acid in human
health (e.g., changes in plasma LDL cholesterol levels) is not well-
established. Furthermore, there is no quantitative intake
recommendation available for stearic acid. Therefore, we tentatively
conclude that the individual declaration of stearic acid is not
necessary to assist consumers in maintaining health dietary practices,
consistent with the factors we consider, discussed in section I.C., and
therefore the declaration would not be permitted on the Nutrition Facts
label.
As discussed in section II.B.1., we received a citizen petition
from Nabisco, Inc. on May 7, 1997 (Docket No. FDA-1997-P-0476)
requesting that FDA amend the definitions of ``total fat'' and
``saturated fat'' in its food labeling regulations to exclude acetic,
propionic, and butyric acids (https://www.regulations.gov/#
!docketDetail;D=FDA-19970-P-0476). With respect to saturated fat, the
petition requested that FDA amend Sec. 101.9(c)(2) to read as follows:
(i) ``Saturated fat,'' or ``Saturated'': A statement of the number of g
of saturated fat in a serving defined as the sum of all fatty acids,
excluding acetic (C:2), propionic (C:3), and butyric (C:4) acids,
containing no double bonds.'' For the same reasons discussed in section
II.B.1. regarding total fat, we are not proposing to exclude acetic,
propionic, and butyric acids from the definition of saturated fat.
b. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act
requires the declaration of the amount of saturated fat on food labels.
Accordingly, FDA regulations require mandatory declaration of the gram
amount for saturated fat (Sec. 101.9(c)(2)).
Dietary recommendations continue to recognize the well-established
relationship between consumption of saturated fat and its effect on
blood cholesterol levels (Refs. 6 and 49). In addition, the 2010 DGA
provided a quantitative intake recommendation for saturated fat. We are
unaware of evidence to support a determination that information
relating to saturated fat on the Nutrition Facts label is no longer
necessary to assist consumers in maintaining healthy dietary practices.
Therefore, we are not proposing to change the requirement for mandatory
declaration of saturated fat on the Nutrition Facts label in Sec.
101.9(c)(2)(i).
c. DRV--The DRV for saturated fat is 20 g, which is 10 percent of
calories based on a 2,000 reference calorie intake level (Sec.
101.9(c)(9)). The IOM Labeling Committee recommended that the DV for
saturated fatty acids (along with trans fatty acids and cholesterol)
should be set at a level that is as low as possible in keeping with an
achievable health-promoting diet and consistent with IOM DRIs (Ref.
25). The IOM Labeling Committee suggested that FDA use food composition
data, menu modeling, and data from dietary surveys to estimate minimum
intakes that are consistent with nutritionally adequate and health-
promoting diets for diverse populations. In the 2007 ANPRM, we asked
for public comment on (1) whether the current DRV for saturated fat of
20 g should be retained and (2) whether food composition data, menu
modeling, and data from dietary surveys should be used to establish a
DRV for saturated fat that is as low as possible while consuming a
nutritionally adequate diet. We received several comments in response
to these questions (Ref. 47).
Current consensus reports that reviewed scientific evidence related
to saturated fatty acid intake continue to recommend saturated fat
intakes of no more than 10 percent of calories, based on risk of CVD.
Specifically, the IOM DRIs recommended that intakes of these fats
should be as low as possible while consuming a nutritionally adequate
diet (Ref. 49). In addition, confirming the relationship between high
intakes of saturated fatty acids and increased risk of unhealthy blood
lipid levels and CHD, the 2010 DGA reaffirmed the recommendation to
reduce saturated fatty acid intake to less than 10 percent of calories
and noted that lowering the intake even more, to 7 percent of calories,
can further reduce the risk of CVD (Ref. 6). The 2002 report from the
National Cholesterol Education Program of the NIH National Heart, Lung,
and Blood Institute established saturated fat intakes of no more than
10 percent of calories as an optimal intake level for reduction of CHD
risk while also establishing intakes of no more than 7 percent of
calories as a therapeutic intake level for treating CHD (Ref. 55).
Although some comments suggested reducing the DRV to 15 g and to lower
the DRV to 7 percent of calories, we are not persuaded to do so because
the current saturated fatty acid recommendation of less than 10 percent
of calories is still appropriate for the general U.S. population and
that the existing DRV of 20 g continues to conform to current dietary
recommendations as a maximum intake level that covers the general U.S.
population.
We do not consider the use of food composition data, menu modeling,
or dietary survey data as a suitable approach to determine DRVs. We
note that the majority of comments opposed the use of such alternative
methods to determine the DRV for saturated fat.
We established the current DRVs based on quantitative intake
recommendations and underlying science on the association between
increased intakes and either reduced risk of chronic disease (e.g.,
dietary fiber and CHD) or increased risk of chronic disease (e.g.,
saturated fat and CHD). The approach to determine DRVs using food
composition data, menu modeling, or dietary surveys has a number of
deficiencies. Menu modeling is an approach, based on available foods in
the marketplace, to design a set of food items for meals, which will
meet certain nutrient or food intake pattern recommendations (Ref. 56).
Menu modeling, by its very nature, would not permit the selection of
DRVs that are based on scientific evidence related to actual public
health outcomes. Furthermore, menu modeling permits the creation of
model menus that may be able to meet certain nutrient thresholds
through the inclusion of foods that are not representative of the type
or quantity of foods eaten in the U.S. population or any specific
population and, thus, may result in nutrient intake levels that do not
reflect typical diets and, as such, may be unachievable or
unreasonable. The use of menu modeling can be appropriate in other
circumstances, such as the use of modeling to determine scenarios of
highest possible nutrient intake levels or potential nutrient profiles
of diets. Thus, food composition data and related models can help
provide useful information about consumption trends and the general
nutrient content of the food supply and can serve as an additional
consideration in choosing a reference point for daily intake that is
realistically achievable and practical in light of the current food
supply and consumption patterns. However, these data cannot form the
primary scientific bases for selecting DRVs. Another challenge with the
use of the menu modeling approach is that numerous and rapid changes to
food formulations can make it difficult for food composition databases
to provide current and accurate estimates of nutrient intakes. Based on
these inherent limitations of menu modeling

[[Page 11896]]

and the data sources used, we tentatively conclude that the menu
modeling approach, as recommended in the IOM Labeling Report, is an
unsuitable method for determining DRVs (or RDIs). Instead, we intend to
continue using science-based recommendations to set DRVs and RDIs. In
the case of saturated fat, as explained previously, the existing
scientific evidence does not support a change to the current 20 g DRV.
Therefore, we are not proposing any changes to the current DRV of 20 g
for saturated fat as specified in Sec. 101.9(c)(9).
3. Trans Fat
a. Definition--FDA defines ``Trans fat'' or ``Trans'' in Sec.
101.9(c)(2)(ii) as the sum of all unsaturated fatty acids that contain
one or more isolated (i.e., non-conjugated) double bonds in a trans
configuration. In the 2007 ANPRM, we did not seek public comment on the
definition of trans fat. However, we received a comment recommending
the exclusion of a specific trans fat isomer, vaccenic acid (18:1 t11)
from the definition of trans fat because, according to the comment,
unlike other trans fat isomers, vaccenic acid may not have adverse
health effects. As discussed in the preamble to the final rule
regarding trans fat labeling (68 FR 41434 at 41461), we defined trans
fatty acids by their chemical structure, not their physiological
effects or functional attributes. While the comment provided us with
some preliminary observational data suggesting that trans fat from
ruminant sources, such as vaccenic acid, may not have the same effects
on CHD risk as trans fat from industrial sources, such as partially
hydrogenated oils, we do not agree that potential differences in
physiological effects should be the basis for determining the specific
isomers to be included in a regulatory definition of trans fat. The
definition for trans fat is its chemical definition which captures all
trans fat isomers that have isolated bonds and, thus, vaccenic acid
would be measured by the analytical method used to determine trans fat
content of foods. This chemical definition is consistent with how
polyunsaturated fat is defined as cis, cis-methylene-interrupted (Sec.
101.9(c)(2)(ii)). Accordingly, we are not proposing to change the
definition of trans fat in Sec. 101.9(c)(2)(ii).
b. Mandatory Declaration--FDA regulations require the declaration
of trans fat on the Nutrition Facts label (Sec. 101.9(c)(2)(ii).
Dietary recommendations continue to recognize the well-established
relationship between consumption of trans fat and its effect on blood
cholesterol levels (Ref. 6). Furthermore, under section 403(r)(3)(C) of
the FD&C Act, we did not object to a 2006 Food and Drug Administration
Modernization Act of 1997 (FDAMA) notification for the health claim
``Diets low in saturated fat and cholesterol, and as low as possible in
trans fat, may reduce the risk of heart disease,'' based on statements
made in the 2005 DGA (Ref. 57). As such, because of its role in chronic
disease, trans fat continues to be a nutrient with public health
significance. We are unaware of evidence to support a determination
that information relating to trans fat on the Nutrition Facts label is
not necessary to assist consumers in maintaining healthy dietary
practices. We tentatively conclude that information on the amount of
trans fat in food products allows consumers to reduce their intake of
trans fat, and thus, reduce the risk of CHD. Therefore, we are not
proposing any changes to the requirement for mandatory declaration of
trans fat on the Nutrition Facts label in Sec. 101.9(c)(2)(ii).
However the Agency recently published a tentative determination that
partially hydrogenated oils, the source of industrially produced trans
fat, may not be generally recognized as safe (78 FR 67169; November 8,
2013). We request comment on whether mandatory labeling of trans fat
would still be necessary if this determination is finalized.
Per Sec. 101.9(c)(2)(ii), if a food contains less than 0.5 g of
trans fat per serving, the content, when declared, is to be expressed
as zero. We received a citizen petition from an individual on January
17, 2007 (Docket No. FDA-2007-P-0404) which requested that FDA amend
the definition of trans fat in its food labeling regulations to express
the value of ``zero'' for trans fat only when there are ``absolutely no
trans fats at all'' and require the use of a symbol (e.g., ``~'') to
indicate when there is ``more than zero but less than 0.5g of trans fat
per tablespoon'' (https://www.regulations.gov/# !docketDetail;D=FDA-
2007-P-0404). The petition claimed that the declaration of zero trans
fats on the label is misleading to consumers because it does not denote
the absence of trans fat (as ``zero'' is defined in Webster's
Dictionary) and that people will consume a food incorrectly thinking
that it has zero amount of trans fat. The petition stated that, because
trans fat is associated with negative effects on heart health, this
situation could be detrimental to people's health.
Validated analytical methodologies that provide sensitive and
reliable estimates of trans fatty acids in all foods at levels below
0.5 g per serving are currently not available. For most nutrients
declared on the nutrition label, the maximum amount permitted for a
declaration of a zero value is governed by the limitations associated
with analytical methods available to determine the content of a
nutrient in a food. The analytical methods used to determine nutrient
content for purposes of compliance are discussed in more depth in
section II.N. The petition did not provide any information on
alternative analytical methodologies that are more sensitive and
reliable nor did the petition provide any evidence to support the claim
that consumers are misled by the provisions for the declaration of zero
trans fat. Thus, we are not proposing any changes to the requirement
for the declaration of zero when trans fat content is less than 0.5 g
per serving.
c. DRV--FDA regulations do not provide a DRV for trans fat. At the
time of the issuance of the trans fat final rule, we concurrently
issued the 2003 ANPRM in the same issue of the Federal Register (68 FR
41507) to solicit information and data on several trans fat labeling
issues. In the 2007 ANPRM, we again requested comments on various
issues related to the DV for trans fat, including the use of food
composition data, menu modeling and data from dietary surveys, and a
potential joint percent DV for trans fat and saturated fat. We received
several comments in response to the 2007 ANPRM. We considered the
recommendations in the IOM Labeling Report, available scientific
evidence, and comments (Ref. 47) received in response to both the 2003
and 2007 ANPRMs.
i. Use of food composition data, menu modeling, and dietary
surveys. FDA considered the approach recommended in the IOM Labeling
Report to use food composition data, menu modeling, and dietary survey
data to estimate a minimum trans fat intake within a nutritionally
adequate diet.
As explained previously (see section II.B.2.c.), we do not consider
food composition data, menu modeling, or dietary survey data suitable
for determining DRVs. Furthermore, such an approach is not linked to a
health outcome, which we have traditionally used as a basis for
determining DRVs. As described in the IOM macronutrient DRI report
(Ref. 49), the IOM reviewed the evidence for trans fat and was not able
to set a UL for trans fat, which indicates that there is insufficient
scientific evidence from which to determine a specific level of trans
fat intake that would likely pose no risk of adverse health effects. We
continue to

[[Page 11897]]

adhere to the approach of determining DRVs for a nutrient based on the
nutrient's association with specific health outcomes (e.g., LDL
cholesterol levels).
As an additional consideration, even if we were to use the menu
modeling approach, it would be difficult to apply such an approach for
trans fat. Current estimates of trans fat content in food composition
databases are not comprehensive and do not include trans fat content
for all foods. The levels of trans fat in foods have changed since the
publication of the 2003 trans fat final rule, in part due to
reformulation of foods (Ref. 58). The numerous and rapid changes to
food formulations can make it difficult for food composition databases
to provide current and accurate estimates of the usual intake of trans
fat.
Therefore, we tentatively conclude that the menu modeling approach,
as recommended in the IOM Labeling Report, is an unsuitable method for
determining an appropriate DRV for trans fat.
ii. Determining a DRV. The IOM did not set a UL for trans fat in
the DRI macronutrient report. The IOM noted that any increase in trans
fat intake increases CHD risk but because trans fats are unavoidable in
ordinary diets, consuming zero percent of calories would require
significant changes in dietary intake patterns that may introduce
undesirable effects and unknown and unquantifiable health risks (Ref.
49). The 2005 and 2010 DGA and the FDA Food Advisory Committee (Refs. 6
and 36) likewise could not set a definitive quantitative intake
recommendation for trans fat. Comments generally supported a single
trans fat DRV and a single percent DV, but noted that such levels are
not possible based on existing science. Although some comments
supported a joint percent DV declaration for saturated and trans fat
combined, the majority of comments opposed it due in large part to the
chemical and physiological differences between these fats. We will
consider determining a DRV for trans fat, if and when scientific
evidence and relevant dietary recommendations become available. At that
time, we will also consider whether a single DRV specific to trans fat
or a provision for joint DV declaration for trans fat and saturated fat
are appropriate. Thus, we tentatively conclude that there is no basis
for setting a DRV for trans fat and, accordingly, we are not proposing
a DRV for trans fat, a joint DRV declaration or joint percent DV
declaration.
4. Polyunsaturated Fat
Polyunsaturated fats represent two general categories: n-6 and n-3
polyunsaturated fatty acids. The most common n-6 and n-3
polyunsaturated fatty acid in food is linoleic acid and [alpha]-
linolenic acid, respectively. Other n-3 fatty acids found in foods,
particularly in fish, are the long chain fatty acids, eicosapentaeneoic
acid (EPA) and docosahexaenoic acid (DHA).
a. Voluntary Declaration--FDA regulations permit, but do not
require, the declaration of polyunsaturated fat (defined as cis, cis-
methylene-interrupted polyunsaturated fatty acids) on the Nutrition
Facts label (Sec. 101.9(c)(2)(iii)).
To determine whether any changes are needed to the current
provision for voluntary declaration, we considered recommendations of
current U.S. consensus reports as well as comments received (Ref. 47)
in response to the 2007 ANPRM, in which we requested comment on whether
declaration of polyunsaturated fat should continue to be voluntary or
made mandatory. Current dietary recommendations advise consumers to
increase intakes of polyunsaturated fatty acids to replace saturated
fatty acids in their diets (Ref. 6). The 2010 DGA recommends limiting
the consumption of saturated fatty acids accompanied with replacing
them with polyunsaturated and monounsaturated fatty acids (Ref. 6).
However, as discussed in this document, the IOM did not set DRIs for
total polyunsaturated fatty acids, but rather provided AIs and AMDRs
each for two specific fatty acids, linoleic acid (an n-6
polyunsaturated fatty acid) and [alpha]-linolenic acid (an n-3
polyunsaturated fatty acid) based on median intakes of each fatty acid
using NHANES data (Ref. 49).
We acknowledge that certain polyunsaturated fatty acids are
essential and understand the interest expressed by some comments that
there is a need to provide information on beneficial fats. However, the
essentiality of a nutrient is not a factor considered for the mandatory
or voluntary labeling of non-statutory nutrients, other than essential
vitamins and minerals (see section I.C). Although certain
polyunsaturated fatty acids are essential, an essential fatty acid
deficiency is basically nonexistent in the United States and,
therefore, is not of public health significance (Ref. 49).
A quantitative intake recommendation is not available from relevant
U.S. consensus reports (see discussion in this document), but there is
well-established evidence to indicate that replacing saturated fatty
acids with polyunsaturated and monounsaturated fatty acids reduces
blood LDL cholesterol levels and, therefore, the risk of CVD (Ref. 30).
The prevalence of CVD in the U.S. population is substantial (Ref. 30).
We are not proposing any changes to the requirement for mandatory
declaration of saturated fat (see section II.B.2.). Because
polyunsaturated fat has public health significance when it replaces
saturated fat, consistent with the factors for voluntary declaration
discussed in section I.C., we are proposing to continue to permit
voluntary declaration of polyunsaturated fat, as provided in Sec.
101.9(c)(2)(iii). We request comment about whether there is an
appropriate alternative analysis to the application of the factors in
section I.C. regarding the voluntary declaration of polyunsaturated
fat.
b. DRV--FDA regulations do not provide a DRV for polyunsaturated
fat. The IOM did not set a DRI or AMDR for polyunsaturated fat, but
provided AIs and AMDRs for two specific essential fatty acids, linoleic
acid (an n-6 polyunsaturated fatty acid) and [alpha]-linolenic acid (an
n-3 polyunsaturated fatty acid) based on median intakes of each fatty
acid using NHANES data (Ref. 49). The AIs for linoleic acid and
[alpha]-linolenic acid are 17 and 1.6 micrograms (mcg)/d, respectively.
The AMDRs for linoleic acid and [alpha]-linoleic acid are 5 to 10
percent of calories and 0.6 to 1.2 percent of calories, respectively.
In the 2007 ANPRM, we asked: (1) Whether a DRV for total
polyunsaturated fat should be derived based upon AIs for linoleic acid
plus [alpha]-linolenic acid; and (2) whether a DRV for total
polyunsaturated fat should be established using the AMDRs for n-6 and
n-3 polyunsaturated fatty acids and, if so, should a midpoint be used.
We received comments in response to these questions (Ref. 47).
We are not able to set an appropriate DRV for polyunsaturated fat
at this time given the lack of established DRIs for total
polyunsaturated fatty acids. We do not consider that the AMDRs or AIs
for linoleic acid and [alpha]-linolenic acid provide a sufficient basis
on which a DRV for polyunsaturated fat could be derived. The AIs for
linoleic and [alpha]-linolenic acid were set based on U.S. median
intake levels because there were insufficient experimental data to set
an RDA (Ref. 49). Similarly, the AMDRs for linoleic acid and [alpha]-
linolenic acid were based on the percent of calories needed to meet the
AI for each fatty acid (lower range) and the percent of calories
representing the highest intake level of each fatty acid (upper range).
As such,

[[Page 11898]]

neither of these values provides an adequate basis on which to
determine a DRV. For these reasons, we disagree with comments that
supported using the sum of AIs or AMDRs to establish a DRV for total
polyunsaturated fat.
Therefore, we tentatively conclude that there is no appropriate
quantitative intake recommendation to form a basis for setting a DRV
for polyunsaturated fat. Accordingly, we are not proposing a DRV for
polyunsaturated fat.
c. Declaration of Individual Polyunsaturated Fatty Acids--The
declaration of individual polyunsaturated fatty acids on the Nutrition
Facts label is not permitted. The IOM did not set DRIs for total n-6
and n-3 polyunsaturated fatty acids, but established AIs and AMDRs for
two specific fatty acids, linoleic acid (an n-6 polyunsaturated fatty
acid) and [alpha]-linolenic acid (an n-3 polyunsaturated fatty acid)
(Ref. 49). The 2007 ANPRM asked for public comment on whether separate
DRVs for linoleic acid and [alpha]-linolenic acid should be established
and, if so, whether the declaration of these nutrients should be
voluntary or made mandatory. We received comments in response to these
questions (Ref. 47).
Linoleic and [alpha]-linolenic acids are essential fatty acids that
differ physiologically and compete metabolically. Based on a review of
relevant scientific research, in 2004, FDA concluded in its qualified
health claim review that there is supportive, but not conclusive,
research to suggest that n-3 polyunsaturated fatty acids (EPA and DHA)
reduce the risk of CHD (Ref. 59). Results of one clinical trial on the
effects of EPA published since 2004 fail to demonstrate a significant
reduction in the hazard ratio for the primary prevention of major
coronary events (Ref. 60).
More recently, the 2010 DGAC concluded that moderate evidence shows
that the consumption of two servings of seafood per week, which
provides an average of 250 mg/d of long-chain n-3 polyunsaturated fatty
acids (i.e., EPA and DHA), is associated with reduced cardiac mortality
from CHD or sudden deaths, both in persons with and without CVD (Ref.
30). The DGAC also concluded that the evidence for plant-derived n-3
polyunsaturated fatty acids (i.e., [alpha]-linolenic acid) in reducing
mortality among persons with existing CVD is limited (Ref. 30).
Similarly, there is no conclusive evidence for an independent role of
n-6 polyunsaturated fatty acids in reducing blood cholesterol levels
and, consequently, the risk of CHD. Evidence suggests that the benefit
of n-6 polyunsaturated fatty acids is observed only as a result of a
reduction in saturated fatty acid intake (Refs. 6 and 59). The IOM
noted that the evidence for a role of EPA and DHA in CHD risk is
growing (Ref. 49), but set AIs and AMDRs for [alpha]-linolenic acid,
not for EPA or DHA.
While a ``healthy'' n-6:n-3 ratio may be important in human health,
such a ratio has not been defined and much of the available evidence is
based on studies conducted in animals, infants, and patients on total
parenteral nutrition and much of the evidence in adults has come from
observational studies (Ref. 49).
Because of the lack of well-established evidence for a role of n-3
or n-6 polyunsaturated fatty acids in chronic disease risk and the lack
of a quantitative intake recommendation, and consistent with the
factors discussed in section I.C., we tentatively conclude that the
declarations of n-3 and n-6 polyunsaturated fatty acids are not
necessary to assist consumers to maintain healthy dietary practices.
Accordingly, we are not proposing to provide for the individual
declaration of either n-3 or n-6 polyunsaturated fatty acids on the
Nutrition Facts label. Similarly, because of the lack of well-
established evidence for a role of EPA and DHA in chronic disease risk
and the lack of a quantitative intake recommendation, consistent with
the factors discussed in section I.C., we tentatively conclude that the
declarations of EPA and DHA are not necessary to assist consumers to
maintain healthy dietary practices. Accordingly, we are not proposing
to provide for the mandatory or voluntary declaration of EPA or DHA on
the Nutrition Facts label. We request comment about whether there is an
appropriate alternative analysis to the application of the factors in
section I.C. regarding the individual declaration of n-3 or n-6
polyunsaturated fatty acids, as well as EPA or DHA.
5. Monounsaturated Fat
a. Voluntary Declaration--FDA regulations currently permit, but do
not require, the declaration of monounsaturated fat (defined as cis-
monounsaturated fatty acids (e.g., oleic acid)) on the Nutrition Facts
label (Sec. 101.9(c)(2)(iii)). To determine whether any changes are
needed to the provision for voluntary declaration, we considered
recommendations in current consensus reports as well as comments
received in response to the 2007 ANPRM (Ref. 47), in which we requested
comment on whether declaration of monounsaturated fat should remain
voluntary or be made mandatory.
In 2002, the IOM noted that there was no known independent role of
monounsaturated fatty acids in preventing chronic disease (Ref. 49).
The lack of an independent effect of monounsaturated fatty acids on
heart disease risk was also substantiated in a 2004 FDA review of a
qualified health claim regarding monounsaturated fatty acids from olive
oil and CHD (Ref. 61). Upon review of data related to this qualified
health claim, we concluded that there was no evidence to indicate that
monounsaturated fatty acids from olive oil, independent of saturated
fatty acid displacement, lower serum total and LDL cholesterol levels.
Most recently, the 2010 DGAC (Ref. 30) noted that there was strong
evidence indicating that monounsaturated fatty acids are associated
with improved blood lipids related to CVD when they replace saturated
fatty acids. Consequently, the 2010 DGA recommends that most fats
should be consumed as polyunsaturated and monounsaturated fatty acids
(Ref. 6). Current dietary recommendations advise consumers to increase
intakes of monounsaturated fatty acids to replace saturated fatty acids
in their diets.
We acknowledge that monounsaturated fatty acids are not essential
in the diet (Ref. 49). However, a lack of essentiality is not a basis
for determining whether a nutrient should be required to be declared
(see section I.C.). Indeed, nonessential nutrients trans fat, saturated
fat, and cholesterol are required to be declared on the label because
of their public health significance. Scientific evidence points to the
positive effects of increased monounsaturated fatty acid intake as a
result of reduced intake of saturated fatty acids.
While a quantitative intake recommendation is not available from
relevant U.S. consensus reports, there is well-established evidence to
indicate that replacing saturated fatty acids with polyunsaturated and
monounsaturated fatty acids reduces blood LDL cholesterol levels and,
therefore, the risk of CVD, and that the prevalence of CVD is
substantial in the United States (Ref. 30). We are not proposing any
changes to the current requirement for mandatory declaration of
saturated fat (see section II.B.2.). Because monounsaturated fat has
public health significance when it replaces saturated fat, consistent
with the factors we consider for voluntary declaration discussed in
section I.C., we are proposing to continue to allow for voluntary
declaration of

[[Page 11899]]

monounsaturated fat, as provided in Sec. 101.9(c)(2)(iii). We request
comment about whether there is an appropriate alternative analysis to
the application of the factors in section I.C. regarding the voluntary
declaration of monounsaturated fat.
b. DRV--FDA regulations do not provide a DRV for monounsaturated
fat. Current consensus reports do not provide specific quantitative
intake recommendations for monounsaturated fatty acids. The IOM did not
set a DRI for monounsaturated fatty acids because these fatty acids are
not essential in the diet and have no known independent role in
preventing chronic diseases (Ref. 49). Therefore, we tentatively
conclude that there is no scientific basis on which we can rely to set
a DRV for monounsaturated fat and, therefore, we are not proposing to
set a DRV for monounsaturated fat.

C. Cholesterol

1. Mandatory Declaration
Section 403(q)(1)(D) of the FD&C Act requires the declaration of
the amount of cholesterol on food labels, and cholesterol content must
be declared on the Nutrition Facts label in accordance with Sec.
101.9(c)(3). Current dietary recommendations continue to recognize the
well-established relationship between consumption of cholesterol and
its effect on blood cholesterol levels, which are a surrogate endpoint
for CHD risk (Ref. 6). In addition, the 2010 DGA provided a
quantitative intake recommendation for cholesterol (Ref. 6) (see
discussion in this document). Furthermore, FDA authorized a health
claim for dietary saturated fat and cholesterol and risk of CHD, for
which we evaluated the scientific evidence on the association between
dietary cholesterol and serum cholesterol levels (Sec. 101.75).
We are unaware of evidence that would support a change to the
requirement for mandatory declaration of cholesterol on the Nutrition
Facts label in Sec. 101.9(c)(3) and, therefore, we are not proposing
any changes to the current requirement for mandatory declaration.
2. DRV
FDA regulations provide a DRV for cholesterol of 300 mg (Sec.
101.9(c)(9)). The IOM Labeling Committee recommended, based on the IOM
DRIs, that the DV for cholesterol (along with saturated fat and trans
fat) should be set at a level that is as low as possible in keeping
with an achievable health-promoting diet (Ref. 25). The IOM Labeling
Committee suggested that FDA use food composition data, menu modeling,
and data from dietary surveys to estimate minimum intakes that are
consistent with nutritionally adequate and health-promoting diets for
diverse populations (Ref. 25). Acknowledging these IOM recommendations,
in the 2007 ANPRM, we asked for public comment on (1) whether the
current DRV for cholesterol of 300 mg should be retained; and (2)
whether food composition data, menu modeling, and data from dietary
surveys should be used to establish a DRV for cholesterol that is as
low as possible while consuming a nutritionally adequate diet. We
considered recommendations in current consensus reports as well as
comments received (Ref. 47).
The 2010 DGA recommends consuming less than 300 mg/d of cholesterol
to help maintain normal blood cholesterol levels and reducing intake to
less than 200 mg/d for individuals at high risk of CVD (Ref. 6). The
IOM also reported a relationship between increased cholesterol intake
and increase in serum cholesterol, a surrogate endpoint for CHD risk
(Ref. 62). The IOM macronutrient report recommended that cholesterol
intakes should be as low as possible while consuming a nutritionally
adequate diet, but did not set ULs for cholesterol (Ref. 62). Based on
the reasons set forth previously, we disagree with the comments
suggesting that a DRV of 300 mg is too low or that there is no strong
association between cholesterol intake and CHD risk, or that current
science justifies eliminating the percent DV declaration.
We do not agree with the IOM recommendation that food composition
data, menu modeling, and data from dietary surveys offer a suitable
approach for determining DRVs. Limitations inherent to menu modeling
and food composition and dietary survey data sources are discussed in
sections II.B.2.c. and II.B.3.c. We established the current DRV for
cholesterol based on quantitative intake recommendations that
considered specific effects on health outcomes (e.g., CHD) (58 FR 2206
at 2217). Use of menu modeling to determine a quantitative intake
recommendation for cholesterol is inconsistent with this approach and
may result in a reference intake level that is not based on scientific
evidence related to actual public health outcomes.
Although the 2010 DGA recommends that cholesterol intake levels
should be less than 200 mg/d for individuals at high risk of CVD, we
consider the DGA recommendation of 300 mg/d for maintaining normal
blood cholesterol levels as an appropriate basis for setting a DRV
because it represents the maximum intake level that covers the general
U.S. population 4 years of age and older. Therefore, we are not
proposing any changes to the DRV for cholesterol of 300 mg specified in
Sec. 101.9(c)(9).

D. Carbohydrate

In this section, we discuss our consideration of provisions related
to definitions, declarations, DRVs, and analytical methods for total
carbohydrate, total sugars, added sugars, dietary fiber, soluble and
insoluble fiber, sugar alcohols, and other carbohydrates.
1. Total Carbohydrate
a. Calculation of Total Carbohydrate--For the purposes of the
Nutrition Facts label, total carbohydrate content is calculated by
subtracting the sum of protein, total fat, moisture, and ash from the
total weight of the food (Sec. 101.9(c)(6)). This calculation method
is called ``carbohydrate by difference'' and is described in A.L.
Merrill and B.K. Watt, ``Energy Value of Foods--Basis and Derivation,''
in the USDA Handbook No. 74 (Ref. 63). Total carbohydrate includes
starch, sugars, sugar alcohols, and dietary fiber.
On July 8, 2004, the National Starch and Chemical Company (National
Starch) submitted a citizen petition requesting that dietary fiber
content be excluded from the calculation of total carbohydrate that is
declared on the Nutrition Facts label (Docket No. FDA-2004-P-0094)
(https://www.regulations.gov/# !docketDetail;D=FDA-2004-P-0094). The
petition noted that consumers wishing to reduce their intake of
carbohydrate may also be inadvertently decreasing their consumption of
high fiber foods, such as whole grains, because dietary fiber is
included in the definition of ``Total Carbohydrate.'' National Starch,
therefore, requested an amendment to the second sentence in Sec.
101.9(c)(6) to read as follows: ``Total carbohydrate content shall be
calculated by subtraction of the sum of the crude protein, total fat,
moisture, ash, and dietary fiber from the total weight of the food.''
The petition noted that excluding dietary fiber from the definition
would be consistent with the way the IOM DRI report and Codex
guidelines refer to carbohydrates and would be a more accurate
representation of the amount of calories contributed by carbohydrates.
To support this request, the petition presented study findings reported
in the New York Times in 2004 and from research conducted on the
Internet. In

[[Page 11900]]

addition, the petition discussed the use of the term ``net carbs'' in
labeling and discussed inconsistencies in the way different
manufacturers define the term ``net carbs.'' According to the petition,
some manufacturers define ``net carbs'' as the amount of total
carbohydrate excluding the amount of dietary fiber and sugar alcohols
while others exclude sugar alcohols and ``other carbohydrates,'' as
specified in Sec. 101.9(c)(6)(iv), or sugar alcohols and ``certain
other carbohydrates.'' The petition suggested that the varied
approaches to describing carbohydrates have led to consumer confusion.
In the 2007 ANPRM, we asked for comment on whether the approach for
calculating total carbohydrate by difference should be retained and, if
not, which specific components should be included or excluded from the
calculation of total carbohydrate. In addition, acknowledging the 2005
DGA recommendation to consume fiber-rich foods, we asked for comment on
whether separating dietary fiber from the amount of total carbohydrate
would affect consumer understanding and use of the information,
particularly with respect to fiber consumption. We received several
comments (Ref. 47).
We reviewed scientific evidence and considered the petition's
requests and comments received. As explained in this document, we
decline to change to the current method for calculating total
carbohydrate by difference.
Under FDA regulations, compliance with certain nutrition labeling
requirements may be achieved by the use of an FDA-approved database
(Sec. 101.9(g)(8)). Nutrient databases include carbohydrate values
that are determined by difference. Changing the way carbohydrate is
calculated would either necessitate an analogous change to the way
carbohydrate is calculated in major nutrient databases, such as the
USDA National Nutrient Database for Standard Reference, or would
substantially decrease the usefulness of these databases in assisting
manufacturers in making nutrient content declarations.
We also considered an alternative approach of calculating total
carbohydrates by summing individual carbohydrate measurements rather
than calculating by difference, as suggested by a comment. There is
variability and error that are introduced with each analytical test
that is performed (Ref. 64). When summing the values from the various
tests, the amount of variability and error would multiply and such an
approach is likely to result in greater variability and error. As
discussed in the documentation for USDA's National Nutrient Database
for Standard Reference, Release 23, when the analyses of starch,
sugars, sugar alcohol, and dietary fiber are performed separately, the
result reflects the analytical variability inherent to each of those
measurement processes (Ref. 65). Thus, such an approach does not
provide any distinct advantage over measuring carbohydrate by
difference.
With respect to removal of dietary fiber from the calculation of
total carbohydrate, we agree that the IOM provided separate DRIs for
carbohydrate (i.e., starch and sugars) and dietary fiber. However, the
IOM DRI Report does not provide recommendations for nutrition labeling.
Furthermore, the report defines dietary fiber as ``non-digestible
carbohydrates and lignin that are intrinsic and intact in plants''
(Ref. 66). Thus, the report acknowledges that dietary fibers, with the
exception of lignin, are carbohydrates. As discussed in section
II.D.5., the definition of dietary fiber adopted by Codex in 2010
specifies that dietary fibers are carbohydrate polymers (Ref. 67). The
Codex Guidelines on Nutrition Labeling, however, indicate that the
nutrient declaration for carbohydrate should be ``available
carbohydrate,'' which is the amount of dietary carbohydrate, excluding
dietary fiber (Ref. 67).
The petition states that the inclusion of dietary fibers in the
calculation of total carbohydrate is not fully aligned with the Codex
Guidelines on Nutrition Labeling. Our rationale for including dietary
fiber in the calculation of total carbohydrate is based on what is
considered to be a carbohydrate. To the extent the petition is
requesting the removal of dietary fiber from the total carbohydrate
calculation due to its physiological effects, we consider in greater
detail in this document the classification and declaration of
carbohydrates based on their chemical definition or their physiological
effects. As discussed in greater detail in this document, we find that
inclusion of dietary fiber in the determination of the label
declaration of total carbohydrate is scientifically sound based on our
chemical definition of total carbohydrate and the analytical methods
used to determine carbohydrate content, as well as being consistent
with the way subcategories of other macronutrients, such as fat, are
listed on the Nutrition Facts label. Dietary fiber is a subset of
carbohydrates. All dietary fibers, with the exception of lignin, are
carbohydrate polymers. Although lignin is not a carbohydrate, it is
tightly bound to other dietary fibers and cannot be easily isolated
using AOAC or equivalent methods. It is, therefore, included in the
calculation of total carbohydrate.
Further, dietary fiber is a mandatory separate listing on the
Nutrition Facts label. Therefore, for consumers who wish to know the
carbohydrate content of a food that excludes dietary fiber, this
information can be deduced by subtracting the declared amount of
dietary fiber from the declared amount of total carbohydrate on the
Nutrition Facts label.
In addition, a calculation based on eliminating dietary fiber
content from the declared value of total carbohydrate would necessitate
calculating total carbohydrate by difference using the current method
and then subtracting from that number the amount of dietary fiber
obtained from separate analysis. This option presents a challenge with
respect to the use of existing databases in the United States, which
include dietary fiber in the calculation of total carbohydrate.
Moreover, the petition provided no references to (and we could not
locate) the studies identified in the petition. We have no data or
information at this time to indicate that removal of dietary fiber from
the declaration of total carbohydrate would promote consumption of
dietary fiber due to lower amounts of carbohydrate contents declared in
nutrition labeling. Finally, to the extent that the petition seeks to
define the term ``net carbs,'' such a request is outside the scope of
this rulemaking. In this proposed rule, we are considering whether to
propose a change in how ``total carbohydrate'' is calculated.
Therefore, to the extent the petitioner is requesting to remove
``dietary fiber'' from the total carbohydrate calculation to prevent
consumer confusion from the term ``net carb,'' we decline to change the
calculation of total carbohydrate by difference on that basis. We
consider the calculation and declaration of ``net carbs'' and the total
carbohydrate calculation and declaration on the label as separate and
distinct. The declaration of total carbohydrate is required under
section 403(q)(1)(D) of the FD&C Act.
For these reasons, we decline to change the method for calculating
total carbohydrate by difference and, therefore, we are not proposing
any changes to the method for calculating total carbohydrate by
difference specified in Sec. 101.9(c)(6).
b. Classification of Carbohydrates Based on a Chemical Definition
or Physiological Effect--In the 2007 ANPRM, we asked for comment on
whether carbohydrates should be classified and declared in nutrition
labeling based on their chemical

[[Page 11901]]

definition (current method) or on their physiological effect (e.g.,
attenuation of blood sugar or laxation if dietary fiber were to be
included in the total carbohydrate declaration), and whether additional
types of carbohydrates (e.g., starch) should be listed separately on
the Nutrition Facts label. We received several comments (Ref. 47) in
response to these questions.
We considered this issue in light of the comments received. We
agree with the comments that stated that classification of
carbohydrates based on validated analytical techniques, which isolate
and measure the individual carbohydrates based on their chemical
structure rather than based on their physiological effects, is
necessary for determining the accuracy of values declared on the label.
Carbohydrates include starch, sugars, sugar alcohols, and dietary
fibers. Different types of carbohydrates have different physiological
effects. The effects of some carbohydrates are not fully understood and
are the subject of debate in the scientific community. Within the
different types of carbohydrate (i.e., starch, sugars, sugar alcohols,
and dietary fibers), too, specific carbohydrates may have different
physiological effects (e.g., different types of dietary fibers) making
it difficult to apply a definition that is based on physiological
effects across a category of carbohydrates. Furthermore, analytical
methods for measuring different types of carbohydrates are based on
chemical structure rather than physiological effect. Given the various
components of total carbohydrate and different types of physiological
effects of each, we disagree that a definition based on ``physiological
effects'' would be a better approach than a chemical definition for
total carbohydrate declaration. The use of a chemical definition is
also consistent with the classification and declaration of fat on the
Nutrition Facts label. Different types of fats identified in nutrition
labeling are not classified based on their physiological effect but
rather on their chemical definition.
Therefore, we are not proposing to use physiological effects of
carbohydrates as a basis for classifying or declaring total
carbohydrate. Accordingly, we are not proposing to change our
provisions for the classification or declaration of carbohydrates
specified in Sec. 101.9(c)(6).
c. Separate Declaration of Additional Individual Types of
Carbohydrates--In the 2007 ANPRM, we asked whether additional types of
carbohydrates (e.g., starch) should be listed separately on the
Nutrition Facts label. We considered comments received (Ref. 47),
which, taken together, did not support declaration of additional types
of carbohydrates. Some comments stated that such additional information
could distract consumers from information that is important, such as
dietary fiber. A few comments that supported the declaration of starch
provided no evidence to support their assertions regarding the benefit
of this declaration for diabetics. Moreover, there is no strong
scientific evidence for us to consider related to the role of starch in
human health. Therefore, we are not proposing to require the separate
declaration of additional types of individual carbohydrates such as
starch on the Nutrition Facts label.
d. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act
requires the declaration of total carbohydrate. Correspondingly,
regulations require the declaration of the amount of total carbohydrate
on the Nutrition Facts label (Sec. 101.9(c)(6)). Carbohydrates are an
essential part of the diet because they provide energy to the cells in
the body, especially the brain, which is dependent on carbohydrate for
proper functioning (Ref. 68). We have no basis on which to reconsider
the requirement for mandatory declaration of the amount of total
carbohydrate on the Nutrition Facts label and comments in response to
the 2007 ANPRM also supported this mandatory declaration. We
tentatively conclude that the declaration of carbohydrates on the
Nutrition Facts label continues to be necessary to assist consumers in
maintaining healthy dietary practices. Therefore, we are not proposing
any changes to the current requirement for mandatory declaration of
total carbohydrate, as specified in Sec. 101.9(c)(6).
e. DRV--The DRV for total carbohydrate is 300 g (Sec.
101.9(c)(9)). The IOM established an AMDR for carbohydrate intake of 45
to 65 percent of energy for adults and an EAR of 100 g/d for adults and
children (Ref. 69). In the IOM report, ``carbohydrate'' only included
starch and sugars, not sugar alcohols or dietary fiber. The IOM also
set the RDA for ``carbohydrate'' (i.e., starch and sugars) at 130 g/d
for adults and children based on the average minimum amount of glucose
utilized by the brain in adults, which was extrapolated to children
ages 1 through 18 years. Subsequently, the IOM Labeling Committee
recommended that, as in the case of protein and total fat, the AMDRs
should be the basis for DVs for total carbohydrate (Ref. 25).
Considering that AMDRs vary with age, the IOM Labeling Committee
recommended a population-weighted midpoint of the AMDR. Under this
approach, using a population-weighted mid-point of the AMDR for adults
and children, i.e., 45 to 65 percent, the DV for total carbohydrate
would amount to 55 percent or, based on a 2,000 calorie reference
calorie intake, 275 g of carbohydrate.
However, as we noted in the 2007 ANPRM, the IOM's AMDR, EAR, and
RDA values for carbohydrate do not include sugar alcohols or dietary
fiber. In contrast, our calculation of total carbohydrates for the
purposes of nutrition labeling accounts for all types of carbohydrates,
including sugar alcohols and dietary fiber. Therefore, applying the IOM
Labeling Committee's approach, in which a DV is derived from the AMDR,
would result in a reference value based on recommendations specifically
for sugars and starches, whereas the absolute gram amount of
carbohydrates declared on the label includes all carbohydrates.
Consequently, if the midpoint of the AMDR range is used as the basis
for the DRV, there would be a discrepancy in what carbohydrates are
encompassed in the information provided on the label for the absolute
gram amount versus the percent DV. We did not ask any questions about
the DRV for total carbohydrate in the 2007 ANPRM nor did we receive any
comments on this issue. Consistent with calculating total carbohydrate
``by difference'' (discussed previously), we are proposing no changes
to the approach to calculate the percent DV for carbohydrate ``by
difference'' as well. In addition, we are not proposing to change the
DRVs for fat or protein (see sections II.B. and II.E.), which are used
to derive the DRV for total carbohydrate. Therefore, we are not
proposing any changes to the DRV for total carbohydrate of 300 g/d. We
note that the RDA for carbohydrate for men and women 19 years of age
and older is 130 g/d. Therefore, the DRV should not be viewed as an
intake requirement, but as a reference amount.
f. Calculation of Calories From Carbohydrate--FDA regulations
require that the calories from total carbohydrate be calculated by
using the general factor of 4 calories/g of carbohydrate less the
amount of insoluble dietary fiber (Sec. 101.9(c)(1)(i)(C)). We are
proposing a new definition of dietary fiber (see section II.D.5.a.i.)
that only allows for the declaration of dietary fibers that we have
determined to have a physiological effect that is beneficial to human
health, as ``dietary fiber'' on the Nutrition Facts label. Therefore,
the new definition of dietary fiber would exclude both soluble and
insoluble non-digestible carbohydrates that do not meet the proposed
definition. For the purposes of

[[Page 11902]]

calculating calories from carbohydrate, all soluble and insoluble non-
digestible carbohydrates should be excluded from the calculation, not
just those known to meet the definition of dietary fiber. To ensure
that all soluble and insoluble non-digestible carbohydrates are
excluded from the calculation of calories from carbohydrate, we are
proposing to amend Sec. 101.9(c)(1)(i)(C) to require that calories
from carbohydrate be calculated using a general factor of 4 calories/g
of total carbohydrate less the amount of non-digestible carbohydrates.
As discussed in section II.D.5.b.v., a value of 2 calories/g of soluble
non-digestible carbohydrates is then added to the calculation.
2. Sugars
a. Definition--Sugars are defined in Sec. 101.9(c)(6)(ii) as a
statement of the number of g of sugars in a serving. They are the sum
of all free mono and disaccharides (e.g., glucose, fructose, lactose,
and sucrose). We received a citizen petition on the term ``sugars''
and, as explained in this document, we are not proposing any changes to
the term or its definition for the purpose of nutrition labeling.
b. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act
requires the declaration of sugars. FDA regulations require the
declaration of sugars on the Nutrition Facts label (Sec.
101.9(c)(6)(ii)).
The Sugar Association submitted a citizen petition on August 16,
2005 (Docket No. FDA-2005-P-0373) requesting among other things that we
eliminate ``sugars'' as a mandatory nutrient that is declared on the
Nutrition Facts label or, alternatively, rename ``sugars'' as ``sugars/
syrup'' and require the mandatory declaration of polyol and artificial
sweeteners on the Nutrition Facts label, as well as the mandatory
labeling of each specific polyol and artificial sweetener ingredient
and its amount on the food label (https://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0373). The petition asserted that consumers
understand ``sugars'' to mean sucrose. The petition stated that an
increasing number of manufacturers are using artificially produced
(alternative) sweeteners, such as high fructose corn syrup, instead of
sucrose products such as table sugar. The petition also asserted that,
under current regulations, information on sugar content is presented in
a manner that is misleading to consumers because it does not reflect
the caloric content of artificially produced sweeteners and does not
identify the specific sweeteners used in food products. The petition
also expressed concern about the potential caloric and health effects
of alternative sweeteners and asserted that the current labeling of
sugar and lack of labeling for artificially produced sweeteners on the
Nutrition Facts label did not provide consumers with relevant
information about alternative sweeteners. However, the petitioner did
not include any data to specifically support these assertions and
concerns.
In the 2007 ANPRM, we requested comment on whether ``sugars''
should continue to be included on the Nutrition Facts label. We
received several comments which were in favor of continuing to require
mandatory labeling of sugars on the Nutrition Facts label (Ref. 47).
We considered the petition and comments received in light of
scientific evidence. There is strong and consistent evidence based on
valid endpoints that consumption of sugars is associated with an
increased risk of dental caries (Refs. 6 and 68). We authorized a
health claim for dietary non-cariogenic carbohydrate sweeteners and
dental caries (Sec. 101.80). The IOM macronutrient report noted that
dental caries is a condition of public health concern that is
associated with consumption of sugars (Ref. 68). Therefore, we
tentatively conclude that the declaration of sugars continues to be
necessary to assist consumers in maintaining healthy dietary practices,
and we are not proposing to change the current requirement for
mandatory declaration of sugars.
Moreover, we decline the petition's request to rename ``sugars'' as
``sugars/syrups'' on the Nutrition Facts label. The petition requested
that we rename the ``sugars'' category to prevent consumers from being
misled with regard to the ingredients that are permitted to be
considered sugars under the current regulation (monosaccharides plus
disaccharides such as high fructose corn syrup). The petition, however,
did not provide data or information to support the assertion that
consumers are misled by the term ``sugars'' on products containing
sweeteners that are a combination of mono and disaccharides, as defined
in Sec. 101.9(c)(6)(ii). We are considering using the term ``total
sugars'' in lieu of ``sugars'' on the Nutrition Facts label if ``added
sugars' declaration is finalized, as proposed. FDA plans to conduct
consumer testing of the terms ``total sugars'' and ``sugars'' on the
Nutrition Facts label (FR 2013-12824) to determine if use of the term
``total sugars'' aids consumers in understanding that added sugars are
part of the total amount of sugars in product.
We also decline the petition's request to require manufacturers to
declare the specific type of artificial sweetener used on the Nutrition
Facts label so that consumers can be made aware of the degree of
substitution, when artificial sweeteners are substituted for sugars,
and the overall level of the artificial sweeteners in the food. Under
FDA regulations, artificial sweeteners that are added to a food are
required to be declared in the ingredient statement of the label. The
petition did not provide any justification that additional information
about artificial sweeteners in nutrition labeling is warranted and we
have no data to suggest that a declaration of artificial sweeteners is
necessary to assist consumers in maintaining healthy dietary practices.
Therefore, we are not proposing any change to the current
requirement for mandatory declaration of sugars on the Nutrition Facts
label, as specified in Sec. 101.9(c)(6)(ii). We are also not proposing
to rename the ``sugars'' category as ``sugars/syrups'' or require the
mandatory declaration of specific sugar alcohols or other artificial
sweeteners.
c. DRV--FDA regulations do not specify a DRV for sugars. Current
consensus reports have not set dietary reference values based on which
we could derive an appropriate DRV for total sugars. While the IOM
found an association between sugar consumption and risk of dental
caries, due to the various factors that contribute to dental caries,
IOM could not determine an intake level of sugars that is associated
with increased risk of dental caries and, therefore, did not have
sufficient evidence to set a UL for sugars (Ref. 68). We did not ask
any questions related to the DRV for sugars in the 2007 ANPRM nor did
we receive any comments recommending the establishment of a DRV for
total sugars. For these reasons, we are not proposing to establish a
DRV for total sugars.
3. Added Sugars
a. Declaration--FDA regulations neither define the term ``added
sugars'' nor require or permit its declaration on the Nutrition Facts
label. We are reconsidering the declaration of added sugars taking into
account new data and information, including U.S. consensus reports and
recommendations related to the consumption of added sugars, a citizen
petition submitted by the CSPI, and public comments. For the purposes
of the discussion in this document, added sugars refer to sugars and
syrups that are added to foods during processing or preparation (Ref.
6).

[[Page 11903]]

i. Consensus Reports. The IOM DRI Report on Macronutrients stated
that ``although added sugars are not chemically different from
naturally occurring sugars, many foods and beverages that are major
sources of added sugars have lower micronutrient densities compared to
foods and beverages that are major sources of naturally occurring
sugars'' (Ref. 68). Although an upper level was not set for total or
added sugars, a maximal intake level of 25 percent or less of energy
from added sugars was suggested based on data that demonstrated
decreased intakes of some micronutrients among American subpopulations
whose intake of added sugars exceeded this level.
In addition, the 2010 DGA (Ref. 6) noted that the primary
prevention of obesity, especially in childhood, is an important
strategy for combating and reversing the obesity epidemic. Over the
last few decades, the prevalence of overweight and obese individuals in
the United States dramatically increased among children, adolescents
and adults. Many factors contribute to weight gain and obesity but
maintaining an appropriate calorie balance and increasing physical
activity and reducing sedentary behaviors are key recommendations to
help combat the problem. The 2010 Dietary Guidelines Advisory Committee
(DGAC) concluded that strong evidence shows that children who consume
more sugar-sweetened beverages have greater adiposity (body fat)
compared to those with a lower intake. The sole source of calories in
many sugar-sweetened beverages (e.g., soda) is added sugars. The 2010
DGA specifically suggest that reducing the intake of sugar-sweetened
beverages may help individuals control their total calorie intake and
manage their body weight. The report stated that Americans consume too
many calories from solid fats (fats containing a high percentage of
saturated and trans fatty acids and are solid at room temperature) and
added sugars and these foods replace nutrient-dense foods and beverages
and make it difficult for people to achieve the recommended nutrient
intake while controlling their calorie intake. Together, solid fats and
added sugars contribute a substantial portion of Americans' calories,
35 percent on average (16 percent total on average from added sugar)
without contributing to the overall nutrient adequacy of the diet and
thus have implications for weight management. Thus, to meet nutrient
needs within an individual's calorie limits, a key recommendation of
the 2010 DGA is to reduce the intake of calories from solid fats and
added sugars.
The report recognized that foods containing solid fats and added
sugars are no more likely to contribute to weight gain than any other
source of calories in an eating pattern that is within calorie limits.
However, reducing the consumption of calories from solid fats and added
sugars allows for increased intake of nutrient-dense foods without
exceeding overall calorie needs. The report recommended several ways to
reduce the consumption of solid fats and added sugars including eating
the most nutrient-dense forms of foods from all food groups, limiting
the amount of solid fats and added sugars when cooking or eating, and
consuming fewer and smaller portions of foods and beverages that
contain solid fats and added sugars. Specifically, the 2010 DGA noted
that, for most people, no more than about 5 to 15 percent of calories
from solid fats and added sugars can be reasonably accommodated in the
USDA Food Patterns, which are designed to meet nutrient needs within
calorie limits. The 2010 DGA also outlined common elements of healthy
eating patterns and stated that reducing the intake of added sugars is
one component.
Although the subject of front-of-package labeling (FOP) is outside
the scope of this proposed rule, we reviewed the IOM Front-of-package
Nutrition Rating Systems and Symbols Committee's final report for their
conclusions on scientific evidence related to the effect of added
sugars on human health. This Committee cited the 2010 DGA
recommendations related to added sugars and noted that while there is a
lack of scientific agreement on the effects of added sugars on health
outcomes independent of the effects of total sugar, there is adequate
evidence that added sugars (whether a solid or liquid) contribute extra
calories to a diet, which could in turn lead to weight gain and obesity
(Ref. 28).
ii. CSPI Petitions. We received a petition from CSPI on August 3,
1999 (hereafter referred to as ``the 1999 CSPI petition'') requesting
that we require the Nutrition Facts label to disclose the quantity of
added sugars present in packaged foods and to set a DRV for refined
sugars added to foods (Docket No. FDA-1999-P-0158) (https://www.regulations.gov/#!docketDetail;D=FDA-1999-P-0158). The petition
stated that the DRV for added sugars should be 40 g based on USDA's
``Food Guide Pyramid'' recommendations that Americans should limit
their daily intake of added sugars to about ten teaspoons (40 g) for a
2,000 calorie healthful diet. The petition cited USDA Economic Research
Service's data that show that the per capita consumption of added
sugars rose by 28 percent from 1983 to 1999 (Ref. 70). The petition
also referred to evidence that added sugars may contribute to obesity
and heart disease, and argued that it is impossible for consumers to
determine how much sugar has been added to foods or how much added
sugars are reasonable to consume because the Nutrition Facts label does
not currently provide this information. Although the petition also
requested that we amend our regulations to prescribe nutrient content
claims and health claims related to ``added sugars,'' those requests
are not considered within the scope of this proposed rule. We received
another petition from CSPI on February 13, 2013 (hereafter referred to
as ``the 2013 CSPI petition''), requesting that we revise the
``sugars'' line of the Nutrition Facts label to address ``added
sugars.'' (Docket No. FDA-2013-P-0217) (https://www.regulations.gov/#!docketDetail;D=FDA-2013-P-0217). CSPI described ``added sugars'' as
``various caloric sweeteners,'' including sucrose, high-fructose corn
syrup, corn sugar, invert sugar, corn syrup ``and others.'' We address
CSPI's request for an ``added sugar'' declaration in this proposed
rulemaking. The data and information provided by the 2013 CSPI petition
in regards to added sugar declaration does not change our current
considerations or rationale for mandating added sugars on the label
that are addressed in this document. Although CSPI included other
requests in its petition, which generally relate to lowering levels of
added sugars in foods, we do not address those requests in the context
of this proposed rule because they are outside the scope of this
proposed rule.
iii. Public Comments. On June 26, 2000, we published a notice of
availability of the 1999 CSPI petition in the Federal Register and
requested comment (65 FR 39414). We received more than 2,700 comments
from individuals, industry, academic institutions, advocacy groups, and
health care groups. Several comments stated that added sugar
declaration should be voluntary and not mandatory (Ref. 47). We did not
ask any questions on added sugars in the 2007 ANPRM. However, we
received comments that supported and others that opposed the
declaration of added sugars on the Nutrition Facts label (Ref. 47).
iv. FDA's Considerations and Proposal. A key recommendation of the
2010 DGA is to reduce the intake of

[[Page 11904]]

calories from solid fats and added sugars. A high intake of calories
from excess solid fat and added sugars can decrease the intake of
nutrient-rich foods in the diet and can increase the overall caloric
intake which could lead to weight management issues. As such, this key
recommendation feeds into two overarching concepts of the intent of the
Dietary Guidelines of maintaining calorie balance over time to achieve
and sustain a healthy weight as well as supporting consumption of
nutrient-dense foods (Ref. 6). As discussed in this document, a
declaration of added sugars on the Nutrition Facts label would assist
consumers in maintaining healthy dietary practices by providing them
with information necessary to meet the key recommendations to construct
diets containing nutrient-dense foods and reduce calorie intake from
added sugars by reducing consumption of added sugars.
The Nutrition Facts label includes the mandatory declaration of the
fatty acids that are contained in solid fats from the DGA
recommendation, in that saturated fatty acids and trans fatty acids are
required to be declared on the Nutrition Facts label. Solid fats are
solid at room temperature and contain a mixture of saturated and
unsaturated fatty acids but tend to contain a high percentage of
saturated or trans fatty acids. The disclosure of saturated fat and
trans fat on the label not only provides information to consumers for
managing their effects on CVD (see sections II.B. and II.C.) but also
could provide a marker for foods that contain solid fats that are
abundant in the diets of Americans and contribute significantly to
excess calorie intake (Ref. 6). However, similar information about
added sugars is not currently available on the Nutrition Facts label.
Thus, we are proposing to require the declaration of added sugars on
the Nutrition Facts label to provide consumers with information that is
necessary to meet the dietary recommendation to reduce caloric intake
from solid fats and added sugars.
Added sugars contribute an average of 16 percent of the total
calories in American diets (Ref. 6). According to NHANES, the major
sources of added sugars in the diet in descending order are soda,
energy and sports drinks, grain based desserts, sugar-sweetened fruit
drinks, dairy-based desserts and candy. Most of these foods are not
nutrient-dense and may add calories to the diet without providing
dietary fiber or essential vitamins and minerals (Ref. 6). The
consumption levels of added sugars alone exceed the discretionary
calorie recommendations of 5 to 15 percent of calories from both solid
fats and added sugars discussed in the 2010 DGA. Although foods
containing solid fats and added sugars do not contribute to weight gain
any more than another calorie source, they make up a significant
percentage of the American diet and are a source of excess calories.
The 2010 DGAC concluded that strong evidence shows that children who
consume sugar-sweetened beverages have increased adiposity (increased
body fat). The 2010 DGAC also concluded that there is a moderate body
of evidence suggesting that greater consumption of sugar-sweetened
beverages is associated with increased body weight in adults and that
under isocaloric controlled conditions, added sugars, including sugar-
sweetened beverages, are no more likely to cause weight gain in adults
than any other source of energy. While the IOM FOP report did not
review scientific data on added sugars, based on the 2010 DGA
recommendation to reduce intake of calories from added sugars, it
concluded that added sugars should be included in an FOP labeling
system. In addition the IOM FOP committee recommended that the FOP
symbol system should be integrated with the Nutrition Facts label so
that the two are mutually reinforcing. The IOM DRI Macronutrient Report
noted the difficulty, among some populations, of consuming adequate
amounts of certain micronutrients when excessive amounts of added
sugars are consumed.
As the CSPI petition pointed out, other groups such as the American
Heart Association (AHA), American Academy of Pediatrics, and World
Health Organization (WHO) have recommended limiting added sugars
consumption. None of these recommendations was based on an increased
risk of obesity or heart disease. Both the AHA and American Academy of
Pediatrics recommendations point out that added sugars intake is
associated with a greater intake of calories and a lower intake of
essential nutrients, whereas the 1990 WHO recommendation for decreasing
added sugars is based on dental caries and that excessive consumption
of these sugars can displace nutrient-containing foods in the diet
(Refs. 71 to 73). While these groups are not recognized as U.S.
consensus groups by FDA, these recommendations support our proposal to
require the mandatory declaration of added sugars so that consumers can
achieve a dietary pattern that is nutrient-dense and that does not
exceed caloric needs from added sugars, consistent with the 2010 DGA
recommendations.
Further, we consider it necessary to require a declaration of added
sugars for all foods for which a Nutrition Facts label is required.
Using the current label, consumers cannot identify or compare the
amounts of added sugars to enable them to follow the recommendation of
the 2010 DGA. We are proposing mandatory declaration of added sugars on
all foods because of (1) the variability in ingredients used, (2) the
need for consumers to have a consistent basis on which to compare
products, (3) the need for consumers to identify the presence or
absence of added sugars, and (4) when added sugars are present, the
need for consumers to identify the amount of added sugars added to the
food. The mandatory declaration of added sugars may also prompt product
reformulation of foods high in added sugars like what was seen when
trans fat labeling was mandated (Ref. 58).
We understand that our rationale to support an added sugars
mandatory declaration in labeling is different from our rationale to
support other mandatory nutrients to date which, consistent with the
factors we describe in section I.C., generally relate to the intake of
a nutrient and risk of chronic disease, a health-related condition, or
a physiological endpoint. U.S. consensus reports have determined that
inadequate evidence exists to support the direct contribution of added
sugars to obesity or heart disease. Specifically, although it is
recognized that sugar-sweetened beverages increase adiposity (body fat)
in children (Ref. 30), neither the 2010 DGA nor the IOM macronutrient
report concluded that added sugars consumption from all dietary
sources, in itself, increases obesity. In fact, the 2010 DGA states
that added sugars do not contribute to weight gain more than any other
source of calories. The evidence submitted by CSPI supporting the
contribution of added sugars to heart disease failed to show a direct
association between added sugars consumption and heart disease risk.
Rather, the evidence shows that the consumption of total carbohydrates
(not added sugars, per se) is associated with an increase in serum
triglyceride levels. Moreover, serum triglyceride level is not an
endpoint that we recognize as a validated surrogate marker for CHD risk
in our evidence-based review system for health claims (Ref. 74).
Nevertheless, for the reasons explained previously that include
providing consumers with the information necessary to follow the 2010
DGA recommendations to reduce the intake of calories from added sugars,

[[Page 11905]]

we tentatively conclude that the declaration of added sugars is
required to assist consumers in maintaining healthy dietary practices.
Additionally, in the absence of uniform added sugars declaration on
the Nutrition Facts label, consumers would not be able to compare the
added sugars content of foods, particularly those that contain both
naturally occurring sugars and added sugars (e.g., yogurt and dairy-
based desserts). Contrary to what one comment stated, the added sugars
declaration in the ingredient statement of a food label may not provide
sufficient or quantitative information for consumers to be able to
formulate diets consistent with the dietary recommendations. Sugars may
be added to foods in the form of various ingredients, such as fruit
juice concentrates, fructose, maltose, sucrose, and honey, and
consumers may not realize that these ingredients are, in fact, forms of
added sugars and would not be able to determine the quantities added.
Thus, as pointed out in some comments, calorie declaration and
ingredient listing do not provide enough information for consumers to
determine the amount of calories derived from added sugars in the food.
We acknowledge that some products may contain only added sugars and no
naturally occurring sugars (e.g., soda) and that the amount shown in
the total ``sugars'' declaration on the Nutrition Facts label for such
products would be the amount of added sugars. In this case, however,
some consumers may still not be able to determine the amount of added
sugars because the term would not appear on the label at all. At this
point in time, we cannot be certain that most consumers would
understand that, in the absence of added sugars declaration, all sugars
in these products are added sugars. Therefore, without the added sugars
declaration, some consumers may perceive the amount of added sugars in
the product differently and some perceived amounts may differ from the
actual amount in the product. Food formulations may vary and
consistency in the mandatory declaration of added sugars is important
so that consumers are not confused.
We recognize that small amounts of added sugars can increase the
palatability of nutrient-dense foods, as suggested by a comment. The
disclosure of added sugars on the label may allow consumers to plan and
construct their diets to include small amounts of added sugars and
still consume adequate amounts of necessary nutrients. Consumers may
select from a variety of such nutrient-dense foods as part of their
overall dietary pattern in a way to reduce or minimize the caloric
contribution of added sugars from such sources. The IOM FOP report
noted that small amounts of added sugars would be appropriate for foods
to earn FOP points in their recommended labeling scheme, which suggests
that small amounts would be appropriate in a balanced diet (Ref. 29).
We acknowledge that, if finalized, a requirement for declaration of
added sugars on the Nutrition Facts label will need to be accompanied
by consumer education on the role of added sugars, along with solid
fats, and the use of the new information on the label in overall
dietary planning. We will be conducting consumer studies that include
questions regarding including added sugars on the Nutrition Facts
label. We plan to use the results of these studies to help inform our
future actions on this issue.
We understand that there are currently no analytical methods that
are able to distinguish between naturally occurring sugars and those
sugars added to a food. However, we do not agree with comments that
analytical limitations should preclude mandatory declaration of added
sugars because there is an alternative method to assess compliance. The
amount of added sugars declared on the label could be verified through
means other than chemical analysis, such as through maintenance and
review of records. The reliance on records for compliance purposes is
not unique to added sugars as we have previously required that
manufacturers provide records under certain circumstances to support
statements made on food labels (for example, with respect to aeration
to reduce fat and caloric content of foods (58 FR 2229 at 2271) and
caloric content of new products with reduced digestibility (58 FR 2079
at 2111)). In addition, in sections II.D.5., II.J.2., and II.J.3., we
are proposing to use records to determine compliance with declared
values of dietary fiber, folate, and vitamin E, under certain specified
circumstances.
We continue to recognize the lack of a physiological distinction
between added and naturally occurring sugars. While comments expressed
concerns that declaration of added sugars could significantly under-
represent the sugars content of many foods with a large quantity of
naturally occurring sugars, we are not proposing to remove the total
sugars declaration (see section II.D.2.) because there continues to be
strong scientific evidence linking total sugars intake with dental
caries. Therefore, the sugar content of foods with naturally occurring
sugars would not be under-reported.
We also considered the appropriateness of voluntary declaration of
added sugars, an approach supported by several comments. However, we
are concerned that voluntary declaration of added sugars may not ensure
that consumers have the information that will allow them to follow the
current dietary recommendations. Added sugars declared voluntarily by
manufacturers on some products, but not on others, either within a
given product category or across different product categories, could be
confusing to consumers, and would not provide consumers with the
information they need to plan their dietary pattern to reduce
consumption of calories from added sugars.
In light of current dietary recommendations that advise Americans
to reduce their intake of calories from added sugars, we consider that
an added sugars declaration will help individuals identify foods that
are nutrient-dense within calorie limits and aid in reducing excess
discretionary calorie intake from added sugars. We tentatively conclude
that the declaration of added sugars on the Nutrition Facts label is
necessary to assist consumers to formulate diets consistent with
current dietary recommendations and, thus, maintain healthy dietary
practices. Therefore, proposed Sec. 101.9(c)(6)(iii) would require the
mandatory declaration of added sugars as an indented line item
underneath the declaration of total sugars on the Nutrition Facts
label. We invite comment on this issue. We also invite comment,
including the submission of research on whether calories from added
sugars should be declared on the Nutrition Facts label in lieu of a
gram declaration of added sugars to aid consumers in maintaining
healthy dietary practices.
FDA regulations require that the statement ``Not a significant
source of ----'' for calories from fat, saturated fat, trans fat,
cholesterol, dietary fiber, sugars, and protein must be placed at the
bottom of the table of nutrient values in the same type size, under the
specific circumstances described for each nutrient in Sec. 101.9(c).
For sugars, the phrase ``Not a significant source of sugars'' must be
placed at the bottom of the table of nutrient values if a statement of
the sugars content is not required and, as a result, not declared. A
statement of sugars content is not required for products that contain
less than 1 gram of sugars in a serving if no claims are made about
sweeteners, sugars, or sugar alcohol content (Sec. 101.9(c)(6)(ii)).
Similar information on added sugars could also be useful to consumers
who are trying to limit their

[[Page 11906]]

intake of added sugars. Therefore, proposed Sec. 101.9(c)(6)(iii)
would require that the phrase ``Not a significant source of added
sugars'' be placed at the bottom of the table of nutrient values if a
statement of the added sugars content is not required and, as a result,
is not declared. We are also proposing that a statement of added sugars
content would not be required for products that contain less than 1
gram of added sugars in a serving if no claims are made about
sweeteners, sugars, or sugar alcohol content (proposed Sec.
101.9(c)(6)(iii)).
In addition, for total carbohydrate, dietary fiber, soluble fiber,
insoluble fiber, sugars, and sugar alcohol, when a serving of the food
contains less than 1 gram of the nutrient, FDA regulations in Sec.
101.9 permit the use the alternative statements ``Contains less than 1
gram'' or ``less than 1 gram,'' and if a serving of the food contains
less than 0.5 grams of the nutrient, the content may be expressed as
zero. Proposed Sec. 101.9(c)(6)(iii) would provide for similar use of
alternative statements, ``Contains less than 1 gram'' and ``less than 1
gram'' for added sugars. In addition, if the serving contains less than
0.5 g of added sugars, we are proposing to permit the content to be
expressed as zero (proposed Sec. 101.9(c)(6)(iii)).
b. Proposed Definition--The term ``added sugars'' is not defined in
FDA regulations. Given our tentative conclusion to require mandatory
declaration of ``added sugars'' on the Nutrition Facts label, we are
proposing to define added sugars. In proposed Sec. 101.9(c)(6)(iii),
we are proposing to define ``added sugars'' as sugars that are either
added during the processing of foods, or are packaged as such, and
include sugars (free, mono- and disaccharides), syrups, naturally
occurring sugars that are isolated from a whole food and concentrated
so that sugar is the primary component (e.g., fruit juice
concentrates), and other caloric sweeteners. This would include single
ingredient foods such as individually packaged table sugar. Sugar
alcohols are not considered to be added sugars. Names for added sugars
include: Brown sugar, corn sweetener, corn syrup, dextrose, fructose,
fruit juice concentrates, glucose, high-fructose corn syrup, honey,
invert sugar, lactose, maltose, malt sugar, molasses, raw sugar,
turbinado, sugar, trehalose, and sucrose. This proposed definition of
added sugars includes what CSPI described as ``added sugars'' in the
2013 CSPI petition.
c. Daily Value--Given our proposal to require the declaration of
added sugars, we also considered establishing a DRV for added sugars.
In its 1999 petition as well as in a published report (Ref. 75), CSPI
recommended that FDA base a DV for ``added sugars'' on suggested limits
of added sugars published in the 1992 USDA's Food Guide Pyramid (Ref.
76). CSPI determined that a DRV for added sugars based on a 2,000
calorie diet would be 10 teaspoons or 40 g of added sugars. Overall,
comments submitted in response to CSPI's 1999 petition were in favor of
this approach to setting a DRV for added sugars. Comments in response
to the 2007 ANPRM also recommended establishing a DV for added sugars
(Ref. 47).
We reviewed scientific evidence and recommendations of consensus
reports, and disagree with the petitioner and comments that there is
currently a sound scientific basis for the establishment of a
quantitative intake recommendation upon which a DRV could be derived.
The IOM did not set a DRI, such as a UL, for added sugars (Ref. 68).
The IOM suggested that no more than 25 percent of energy should be
consumed from added sugars, but noted that a defined intake level at
which inadequate micronutrient intakes occur could not be identified.
The 2010 DGA did not provide a quantitative intake recommendation for
added sugars intake but did provide a maximum intake level for solid
fats and added sugars at 13 percent of calories for a 2,000 calorie
diet based on food pattern modeling of the USDA Food Patterns and also
described the ``DASH'' (Dietary Approaches to Stop Hypertension) eating
plan which recommends 5 servings or less per week of sweets and added
sugars for a 2,000 calorie diet (Ref. 6). The USDA Food Patterns, which
provide recommended amounts of foods from each food group that
individuals should consume in order to meet their nutrient needs within
a specific calorie level, specify that the maximum amount of calories
from solid fats and added sugars that can be consumed at the 2,000
calorie level while staying within calorie limits is 258 calories (Ref.
6). The solid fats and added sugars limit at each calorie level in the
USDA Food Patterns is determined by calculation through food pattern
modeling rather than on any biomarker of risk of disease or other
public health endpoint. However, an exact amount of calories for added
sugars is not detailed in either the USDA Food Patterns or ``DASH''
eating plans, as they represent templates that translate and integrate
dietary recommendations, rather than specific quantitative intake
recommendations (Ref. 6). Thus, we have no scientifically supported
quantitative intake recommendation for added sugars on which a DRV for
added sugars can be derived. Therefore, we are not proposing a DRV for
added sugars. Accordingly, the proposed rule, if finalized, would
declare added sugars on the Nutrition Facts label only in absolute
amounts (in g), similar to the declaration of total sugars.
d. Compliance--As expressed in the preamble to the 1993 RDI/DRV
final rule, we are not aware of an analytical method that is capable of
distinguishing between added and intrinsically occurring sugars in a
food product (58 FR 2206 at 2222). Thus, it is not technologically
feasible for us to rely on an analytical method to determine compliance
with the declaration of added sugars in foods that contain both added
sugars and naturally occurring sugars. We recognize that enforcement of
the mandatory declaration of added sugars content will require an
alternative means of verifying compliance and are proposing in Sec.
101.9(g)(10) to include records requirements related to the added
sugars declaration in food. Similarly, in the other cases where there
are not reliable and appropriate analytical methods that will allow us
to verify the amount of a given nutrient in a food (dietary fiber,
vitamin E (tocopherol), and folate), we are also proposing to require
manufacturers make and keep certain records necessary to verify the
amount of these nutrients present in a food (see proposed Sec.
101.9(g)(10)). In the case of added sugars that are not subject to
fermentation, when a mixture of naturally occurring and added sugars is
present in the food, we are proposing that a manufacturer must make and
keep written records of the amount of added sugars added to the food
during the processing of the food, and if packaged as a separate
ingredient, as packaged (whether as part of a package containing one or
more ingredients or packaged as a single ingredient) to verify the
amount of added sugars present in the food (Sec. 101.9(g)(10)(iv)).
(See section II.N for more details about this requirement.)
i. Reactions during processing. Sugars in some foods may undergo
chemical changes mediated by chemical reactions from non-enzymatic
browning (i.e., Maillard reactions and caramelization) and fermentation
during food processing. During these reactions, some sugars are
metabolized or otherwise transformed and converted into compounds that
are no longer recognizable or detectable as sugars through conventional
analytical methods (Ref. 77). We expect that the

[[Page 11907]]

amount of added sugars transformed during non-enzymatic browning
reactions is insignificant relative to the initial levels of sugars
(Ref. 78).
Unlike browning reactions, fermentation is a process that typically
involves the action of desirable microorganisms (e.g., yeasts and
lactic acid bacteria) and enzymes to convert organic compounds,
especially sugars and other carbohydrates, to simpler compounds such as
carbon dioxide, lactic acid, and ethyl alcohol (Refs. 52 and 79).
Typical foods that are subject to fermentation during manufacturing are
breads, cheese, yogurt, vinegar, vegetables, meats, beer and wine. Some
foods, such as sweetened, yeast-leavened breads and wines that are
processed through a fermentation step contain added sugars which will
likely be consumed by the microorganisms during fermentation; other
foods processed through a fermentation step contain added sugars that
will likely not be consumed to a large extent, if at all, during
fermentation, for example, yogurt sweetened with sucrose. In addition,
many products processed through a fermentation step, such as cheese, do
not contain added sugars to aid in fermentation or improve taste (Ref.
78). Therefore, we tentatively conclude that the amount of added sugars
present in foods prior to undergoing fermentation, with the exception
of yeast-leavened bakery products, wines with less than 7 percent
alcohol by volume, and beers that do not meet the definition of a
``malt beverage'' as defined by the Federal Alcohol Administration Act
(27 U.S.C. 211(a)(7)) with sugars added during the fermentation
process, will not be significantly affected by virtue of the food
having undergone fermentation. We do not have adequate information to
assess the degradation of added sugars during fermentation for yeast-
leavened bakery products, wine with less than 7 percent alcohol by
volume, and beers that do not meet the definition of a malt beverage
with sugars added before or during the fermentation process. (Ref. 78).
We request comments, including available data and information, on
our tentative conclusions with respect to added sugars in products that
are subjected to non-enzymatic browning reactions and fermentation. We
specifically request data on the amount of variability that occurs
among various types of products where added sugars are transformed into
other compounds as a result of chemical reactions during food
processing.
ii. Records required to assess compliance. For yeast-leavened
bakery products, wines with less than 7 percent alcohol by volume, and
beers that do not meet the definition of a malt beverage with sugars
added before and during the fermentation process, it is unclear to us
whether, as with most fermented foods, the reduction in the amount of
added sugars would be insignificant. In addition to the records we
propose to require for added sugars in foods generally, under proposed
Sec. 101.9(g)(10), we recognize that there is a need to consider other
types of records related to added sugars content for a yeast-leavened
bakery product, wine with less than 7 percent alcohol by volume, or a
beer that does not meet the definition of a malt beverage when sugars
are added to the food before or during the fermentation process (e.g.
the added sugars are present during fermentation and the amount may be
reduced by the fermentation process). Because of the unique issues that
may be associated with a yeast-leavened bakery product, wine with less
than 7 percent alcohol by volume, or a beer that does not meet the
definition of a malt beverage when added sugars are present during the
fermentation process (Ref. 78), we are proposing a new subparagraph
(Sec. 101.9(g)(10)(v)) to specifically address records requirements
for these products.
Some manufacturers of yeast-leavened bakery products, wine with
less than 7 percent alcohol by volume, and beers that do not meet the
definition of a malt beverage where sugar is added before or during the
fermentation process would likely have more detailed information about
the reduction in added sugars from the process for the products they
manufacture. Thus, we anticipate that manufacturers of some of these
foods that undergo fermentation would be able to determine the amount
of added sugars in the finished food product. For example,
manufacturers could choose to determine through laboratory analysis the
amount of added sugars as well as naturally occurring sugars consumed
in their product during the fermentation process. Other manufacturers
that are unable to conduct additional laboratory analyses of their
product may rely on a scientific document (e.g., journal article or
reference book) showing the amount of added sugars typically consumed
during fermentation in a specific food product (see proposed Sec.
101.9(g)(10)(v)(A)). Manufacturers may use information gathered through
additional analyses or from scientific references to adjust the amount
of sugars added in processing to achieve the desired taste and
organoleptic properties in the finished food product.
We also recognize that some manufacturers of these foods may not be
able to use scientific data and information to verify the amount of
added sugars in the finished food product. We tentatively conclude that
it is appropriate to include, as an alternative to the use of
scientific data and information for such verification, proposed record
requirements for the amount of added sugars added to these products
before and during fermentation for the verification of the declaration
of added sugars content (see proposed Sec. 101.9(g)(10)(v)(B)). As
with other products containing added sugars, the amount of sugars added
before or during fermentation could be determined through information
such as databases, recipes, formulations, or batch records.
Therefore, we are proposing, in Sec. 101.9(g)(10)(v), to require a
manufacturer of yeast-leavened bakery products, wines with less than 7
percent alcohol by volume, and beers that do not meet the definition of
a malt beverage with sugars added before and during the fermentation
process to make and keep records of added sugars necessary to determine
the amount of added sugars present in the finished food in one of two
ways. The first would require the manufacturer to make and keep records
of all relevant scientific data and information relied upon by the
manufacturer that demonstrates the amount of added sugars in the food
after fermentation and a narrative explaining why the data and
information are sufficient to demonstrate the amount of added sugars
declared in the finished food. When the manufacturer is relying upon
scientific data and information from reference documents to determine
the amount of added sugars in these finished food products, the
information used must be specific to the type of fermented food
manufactured. For example, if a manufacturer produces raisin bread, the
reference that the manufacturer is relying upon would need to show the
amount of sugars typically consumed in raisin bread that undergoes
fermentation. The second would require the manufacturer to make and
keep records of the amount of added sugars added to the food before and
during the processing of the food, and, if packaged as a separate
ingredient, as packaged (whether as part of a package containing one or
more ingredients or packaged as a single ingredient). The records would
need to be made available to FDA consistent with the proposed
requirements in Sec. 101.9(g)(11).
It is likely that the actual amount of added sugars remaining in
yeast-leavened breads, wines with less than 7

[[Page 11908]]

percent alcohol by volume, and beers that do not meet the definition of
a malt beverage after they undergo fermentation will be less than the
amount added before processing. We are proposing in section II.N to
allow for reasonable deficiencies of added sugars under labeled amounts
that are acceptable within current good manufacturing practice in Sec.
101.9(g)(6). Because the consumer is not generally harmed if the amount
declared on the nutrition label is a reasonable overage of the actual
amount as indicated by Sec. 101.9(g)(6), when the manufacturer
chooses, as the declaration, the amount of sugars added to these
specific foods before fermentation, the we consider the actual amount
of added sugars in the finished food product to be a reasonable
deficiency under Sec. 101.9(g)(6). In some cases of these specific
fermented foods, when the amount of sugar added to a product before
fermentation is declared, it will exceed the amount of total sugars in
the finished food product determined through laboratory analysis. This
is due to the fact that the amount of added sugars consumed during the
fermentation process is not reflected in the declared amount. In such
cases, the we tentatively conclude that it may be confusing to the
consumer if the amount of added sugars declared exceeds the amount of
total sugars declared on the Nutrition Facts label. Therefore, we are
proposing in Sec. 101.9(g)(10)(v)(B) that the amount of added sugars
declared shall not exceed the amount of total sugars declared on the
label.
4. Sugar Alcohols
FDA regulations define sugar alcohols, in part, as the sum of
saccharide derivatives in which a hydroxyl group replaces a ketone or
aldehyde group (e.g., mannitol or sorbitol) (Sec. 101.9(c)(6)(iii)).
a. Voluntary Declaration--FDA regulations permit the voluntary
declaration of sugar alcohols on the Nutrition Facts label (Sec.
101.9(c)(6)(iii)). In 2005, we received a citizen petition from the
Sugar Association (Docket No. 2005-P-0373) requesting, among other
requests, mandatory declaration of sugar alcohols on the Nutrition
Facts label (https://www.regulations.gov/#!docketDetail;D=FDA-2005-P-
0373). The petition stated that, without this information, consumers
would be misinformed about important modifications to foods and cannot
make informed decisions about their particular sensitivity to the
potential effects of sugar alcohols on the body. In the 2007 ANPRM, we
asked whether the declaration of sugar alcohols should continue to be
voluntary or made mandatory. We considered comments received (Ref. 47)
as well as arguments presented by the petition.
We tentatively conclude that declaration of sugar alcohols should
continue to be voluntary. Although a quantitative intake recommendation
for sugar alcohols is not available from relevant U.S. consensus
reports, sugar alcohols have positive health effects when they replace
sugars in the diet. For example, there is well-established evidence to
indicate that replacing sugars in the diet with sugar alcohols reduces
the risk of dental caries, including the evidence used to support the
health claims authorized by FDA on sugar alcohols and dental caries (72
FR 52783 at 52785; Sec. 101.80). Therefore, we tentatively conclude
that sugar alcohols have public health significance and, in the absence
of a quantitative intake recommendation, voluntary declaration is
consistent with the factors we consider for when voluntary declaration
is appropriate (section I.C.). Accordingly, we are proposing to
continue to provide for the voluntary declaration of sugar alcohols (in
Sec. 101.9(c)(6)(iii) redesignated as Sec. 101.9(c)(6)(iv)).
We disagree with the petition that mandatory declaration of sugar
alcohols is necessary to ensure that consumers are not misinformed
about modifications to foods. Sugar alcohols that are added to food
must be listed in the ingredients list on food labels and, therefore,
consumers will be informed of their use in a product. We also disagree
with the comment that supported mandatory declaration when there is at
least 1 gram of sugar alcohols per serving due to gastrointestinal
problems at such a level. As warranted, FDA regulations require
specific labeling statements to accompany the use of certain sugar
alcohols to provide information to consumers about any gastrointestinal
effects. For example, in the case of mannitol and sorbitol, the
statement ``Excessive consumption may have a laxative effect,'' is
required on the label and labeling of a food whose reasonably
foreseeable consumption may result in a daily ingestion of 20 g for
mannitol (21 CFR 180.25) and 50 g for sorbitol (Sec. 184.1835 (21 CFR
184.1835)).
b. Use of the Term ``Sugar Alcohol''--In 1995, we received a
citizen petition submitted by the Calorie Control Council requesting
the use of the term ``polyols'' in lieu of ``sugar alcohols'' (Docket
No. FDA-1995-P-0142) (https://www.regulations.gov/#!docketDetail;D=FDA-
1995-P-0142). The petition stated that ``polyol'' is a regulatory term
used in other countries, such as Canada and New Zealand. In addition,
the petition cited a survey that showed that 78 percent of consumers
surveyed thought that products with sugar alcohol contained some sugar
even when labeled ``sugar free'' and 69 percent thought that the
product contained some alcohol. We considered the petition as well as
comments in response to the 2007 ANPRM (Ref. 80).
We previously considered the use of ``polyol'' (a contraction of
``polyalcohol'') and determined that it could be potentially more
confusing to consumers than the term ``sugar alcohol.'' However, we
acknowledge that consumers also may not be familiar with the term
``sugar alcohol.'' Therefore, in Sec. 101.9(c)(6)(iii), we allow for
the use of the name of the specific sugar alcohol in lieu of ``sugar
alcohols,'' provided that only one sugar alcohol is present in the
food, since many of the sugar alcohols are listed as ingredients (e.g.,
sorbitol, mannitol, xylitol) and hence may be more recognizable for
consumers (58 FR 2079 at 2100).
We continue to support the term ``sugar alcohols'' rather than
``polyols,'' because ``sugar alcohols'' more accurately describes the
group of substances encompassed in the definition in Sec.
101.9(c)(6)(iii). ``Polyols'' includes non-carbohydrate polyalcohols,
such as polyesters, whereas ``sugar alcohols,'' as defined by FDA,
includes only carbohydrates. Accordingly, we are not proposing to
change the term ``sugar alcohols'' when used on the Nutrition Facts
label, as specified in Sec. 101.9(c)(6)(iii) redesignated as Sec.
101.9(c)(6)(iv).
c. DRV--FDA regulations do not provide a DRV for total sugar
alcohols or for individual sugar alcohols. A quantitative reference
intake recommendation for sugar alcohols is not available from current
consensus reports and we have no basis on which to consider setting an
appropriate DRV. Therefore, we are not proposing to set a DRV for sugar
alcohols.
d. Caloric Value--The caloric value for carbohydrates, other than
insoluble fiber, is 4 kcal/g (Sec. 101.9(c)(1)(i)(C)). Sugar alcohols
have been shown to have a caloric value lower than 4 kcal/g (Refs. 81
and 82). The 2007 ANPRM asked for comment on (1) how the energy
contribution of sugar alcohols should be represented on the label since
energy values vary, and (2) what analytical methods could be used to
determine the energy contribution of sugar alcohols. We considered
comments received (Ref. 47). We also considered relevant caloric values
recommended by the Life Sciences Research Office (LSRO) that

[[Page 11909]]

were determined by various methods, including studies conducted in
animals and human subjects, and based on the amount of energy
metabolized or net energy values (Refs. 81 and 82). LSRO expert panel
reports provided the following caloric values for individual sugar
alcohols: Isomalt (2.0 kcal/g), lactitol (2.0 kcal/g), xylitol (2.4
kcal/g), maltitol (2.1 kcal/g), sorbitol (2.6 kcal/g), hydrogenated
starch hydrolysates (3.0 kcal/g), and mannitol (1.6 kcal/g).
We support the use of the LSRO caloric values for individual sugar
alcohols. The LSRO reports used appropriate methods and study design
criteria for measuring caloric value, and noted that human data were
preferred and that animal data should be viewed as supplemental
information. We do not have any data that would question the caloric
values determined by the LSRO reports for the specified sugar alcohols.
We did not identify any human studies published since the release of
the LSRO reports that demonstrate that a different caloric value for
any of these sugar alcohols would be more appropriate. Therefore, we
are proposing to amend Sec. 101.9(c)(1)(i)(F) to establish the
following general factors for caloric values of sugar alcohols, using
the values recommended by LSRO: Isomalt--2.0 kcal/g, lactitol--2.0
kcal/g, xylitol--2.4 kcal/g, maltitol--2.1 kcal/g, sorbitol--2.6 kcal/
g, hydrogenated starch hydrolysates--3.0 kcal/g, and mannitol--1.6
kcal/g. Accordingly, we are also proposing to amend Sec.
101.9(c)(1)(i)(C) such that the 4 kcal/g is not applied to sugar
alcohols.
5. Dietary Fiber
a. Dietary Fiber
i. Definition. FDA regulations do not establish a definition for
dietary fiber. There is no specific chemical definition for dietary
fiber. Because of the difficulties in accurately isolating the set of
fibers relevant to health, in 2001, the IOM established a panel to
develop a new definition of dietary fiber (IOM Panel on the Definition
of Dietary Fiber or IOM Panel). Subsequently, the IOM then issued a
report defining ``total fiber'' as the sum of ``dietary fiber'' and
``added fiber,'' where ``dietary fiber'' consists of non-digestible
carbohydrates and lignin that are intrinsic and intact in plants, and
``added fiber'' (referred to as ``functional fiber'' in the IOM
Macronutrient Report) consists of isolated, non-digestible
carbohydrates that have beneficial physiological effects in humans
(Ref. 24). The IOM's definitions of ``dietary fiber'' and ``total
fiber'' only include those fibers that are considered to have health
benefits. The 2007 ANPRM asked for public comment on whether the IOM
dietary or functional fiber definitions should become the FDA
definition for dietary fiber. We also asked whether it should develop
criteria for identifying fibers that demonstrate a physiological
benefit, and, if so, what those criteria should be. We received several
comments (Ref. 47).
We considered IOM recommendations, comments received, and relevant
international guidelines. The Codex Alimentarius Commission adopted the
following definition of dietary fiber in 2010 (Ref. 67):
``Dietary fibre means carbohydrate polymers \1\ with ten or more
monomeric units,\2\ which are not hydrolysed by the endogenous enzymes
in the small intestine of humans and belong to the following
categories:
---------------------------------------------------------------------------

\1\ ``When derived from a plant origin, dietary fibre may
include fractions of lignin and/or other compounds associated with
polysaccharides in the plant cell walls. These compounds also may be
measured by certain analytical method(s) for dietary fibre. However,
such compounds are not included in the definition of dietary fibre
if extracted and re-introduced into a food.'' (Ref. 67).
\2\ ``Decision on whether to include carbohydrates from 3 to 9
monomeric units should be left to national authorities.'' (Ref. 67).
---------------------------------------------------------------------------

Edible carbohydrate polymers naturally occurring in the
food as consumed,
Carbohydrate polymers, which have been obtained from food
raw material by physical, enzymatic or chemical means and which have
been shown to have a physiological effect of benefit to health as
demonstrated by generally accepted scientific evidence to competent
authorities, and
Synthetic carbohydrate polymers which have been shown to
have a physiological effect of benefit to health as demonstrated by
generally accepted scientific evidence to competent authorities.
As with the IOM definition of ``total fiber,'' the 2010 Codex
definition for ``dietary fiber'' includes naturally occurring fibers
and only those non-digestible carbohydrates added to food that have a
physiological effect that is beneficial to human health.
Dietary fiber represents a heterogeneous group of compounds that
vary in their carbohydrate composition, linkages between carbohydrates,
and molecular weight. As stated previously, there is no specific
chemical definition for dietary fiber. Therefore, considering the IOM
and Codex definitions and comments received, as well as the role of the
dietary fiber declaration on the Nutrition Facts label, we tentatively
conclude that a regulatory definition for dietary fiber should be one
that emphasizes its physiological effect that is beneficial to human
health. The declaration of dietary fiber that accurately reflects the
amount of fiber that provides a physiological effect that is beneficial
to human health would assist consumers in maintaining healthy dietary
practices.
We are proposing a single definition for dietary fiber that is
equivalent to the IOM's definition for ``total fiber,'' rather than
IOM's separate definitions of ``dietary fiber'' and ``functional
fiber.'' Because both ``dietary fiber'' and ``functional fiber'' as
defined by IOM are considered to have beneficial health effects, we
tentatively conclude that there is little benefit for consumers in
distinguishing between these two types of fiber on the Nutrition Facts
label. In addition, the IOM itself recognized analytical limitations in
distinguishing between ``dietary fiber'' and ``functional fiber'' and
noted that the labeling of ``total fiber'' would be more practical than
labeling ``dietary fiber'' and ``functional fiber'' separately (Ref.
24).
The Codex definition includes a minimum degree of polymerization
(DP) for a carbohydrate of 10, and it also provides that the inclusion
of non-digestible carbohydrates with 3 to 9 monomeric units should be
left to national authorities. The IOM's definition for ``total fiber''
includes those non-digestible carbohydrates of 3 to 9 DP (Ref. 24).
Because we seek to include in our definition non-digestible
carbohydrates with physiological effects that are beneficial to human
health, regardless of size, we are proposing to adopt a definition for
total fiber that includes a DP of >= 3, consistent with the IOM's
definition.
Therefore, we are proposing to amend Sec. 101.9(c)(6)(i) to
include the following definition for dietary fiber: (1) Non-digestible
soluble and insoluble carbohydrates (with 3 or more monomeric units)
and lignin that are intrinsic and intact in plants; (2) isolated and
synthetic non-digestible carbohydrates (with 3 or more monomeric units)
that FDA has granted be included in the definition of dietary fiber, in
response to a petition submitted to FDA under Sec. 10.30 (21 CFR
10.30) demonstrating that such carbohydrates have a physiological
effect(s) that is beneficial to human health; or (3) isolated and
synthetic non-digestible carbohydrates (with 3 or more monomeric units)
that are the subject of an authorized health claim. We invite comment
on the proposed definition of dietary fiber.
As proposed, under provisions 2 and 3, manufacturers would be
required to provide evidence to FDA to demonstrate

[[Page 11910]]

the physiological effects that are beneficial to human health, of
isolated and synthetic non-digestible carbohydrates added to food, and
FDA would have to grant a petition or authorize a health claim before
they can be considered as ``dietary fiber'' for declaration on the
Nutrition Facts label. Manufacturers would use the citizen petition
process in Sec. 10.30 or, in case of a related health claim, the
health claims petition process in Sec. 101.70. We intend to issue
guidance to industry on submissions to demonstrate physiological
effects that are beneficial to human health.
Under these proposed provisions, both [beta]-glucan soluble fiber
(Sec. 101.81(c)(2)(ii)(A)) and barley [beta]-fiber (Sec.
101.81(c)(2)(ii)(A)(6)) that are added to foods would meet the
definition of dietary fiber and, therefore, would be included in the
amount of dietary fiber declared on the Nutrition Facts label. We are
proposing to list isolated and synthetic non-digestible carbohydrates
that have been determined by FDA to have a physiological effect that is
beneficial to human health, in Sec. 101.9(c)(6)(i). Accordingly, we
are proposing to amend Sec. 101.9(c)(6)(i) to list [beta]-glucan
soluble fiber and barley [beta]-fiber (as these substances are
described in Sec. 101.81(c)(2)(ii)(A) and (c)(2)(ii)(A)(6),
respectively) as isolated and synthetic non-digestible carbohydrates
that have been determined by FDA to have a physiological effect that is
beneficial to human health and, therefore, must be included in the
declaration of dietary fiber. Under this process, we would amend Sec.
101.9(c)(6)(i) to list any additional isolated and synthetic non-
digestible carbohydrates that FDA determines have a physiological
effect that is beneficial to human health, through either the citizen
petition process or the health claims petition process.
ii. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act
specifies, in part, that for each serving size or other unit of measure
of a food, the amount of dietary fiber must be provided. Accordingly,
FDA regulations require the declaration of dietary fiber on the
Nutrition Facts label, as provided in Sec. 101.9(c)(6)(i).
We did not ask any questions about the mandatory labeling of
dietary fiber in the 2007 ANPRM, and we received no comments on this
subject. Dietary fiber is not an essential nutrient. However, it has
physiological effects that are beneficial to human health, such as
attenuation of postprandial blood glucose concentrations, attenuation
of blood cholesterol concentrations, and improved laxation (Ref. 66).
The IOM DRI report noted that consumption of certain dietary fibers,
particularly those that are poorly fermented (i.e., insoluble fiber),
improve fecal bulk and laxation and ameliorate constipation (Ref. 66).
In addition, soluble fiber plays a beneficial role in reducing the risk
of heart disease (Ref. 66). ``Dietary fiber'' is identified as a
nutrient of public health concern in the 2010 DGA. The 2010 DGA also
emphasized the consumption of whole grains, in part, because they are a
source of dietary fiber, noting that choosing whole grains that are
higher in dietary fiber has health benefits in addition to meeting
nutrient needs (Ref. 6).
Given the health benefits of dietary fiber, we have no basis to
conclude that the declaration of dietary fiber is no longer necessary
to assist consumers in maintaining healthy dietary practices.
Therefore, we are not proposing to change our current requirement for
the mandatory declaration of dietary fiber in Sec. 101.9(6)(i).
With respect to the term used to declare dietary fiber content on
the Nutrition Facts label, we considered comments received in response
to the 2007 ANPRM (Ref. 47). The term ``dietary fiber'' has been listed
on the Nutrition Facts label since 1993. One survey pointed out by
comments suggests that both ``fiber'' and ``dietary fiber'' are
similarly acceptable by consumers (Ref. 47). Alternative terms such as
``natural fiber'' or ``isolated fiber'' would not be appropriate to
declare all dietary fiber given that we are proposing a definition of
dietary fiber that includes both natural fiber and fiber that is added
to food. Although the IOM used the term ``total fiber,'' there is no
evidence to suggest that this term is preferable to the term ``dietary
fiber.'' Therefore, we are not proposing to change the current
requirement to declare dietary fiber using the term ``dietary fiber,''
as specified in Sec. 101.9(f). However, we request comment on this
issue, including consumer understanding of the term ``dietary fiber''
relative to other relevant terms.
iii. Analytical methods. Per FDA regulations, compliance with the
requirement for declaration of dietary fiber is determined using
appropriate AOAC analytical methods (58 FR 2079 at 2113; Sec.
101.9(g)(2)). In the 2007 ANPRM, we noted the IOM Panel's consideration
of analytical issues related to dietary fiber, and asked whether we
should continue to use the AOAC International methods to determine the
amount of dietary fiber and, if not, what other or additional methods
should be used.
We reviewed comments (Ref. 47) received as well as current AOAC
methods for dietary fiber and the various analytes measured by these
methods in light of our proposed definition for dietary fiber. AOAC
methods, such as AOAC 985.29, 991.43 and 994.13, measure soluble and
insoluble polysaccharides, lignin, higher molecular weight non-
digestible oligosaccharides (DP > 12), and some resistant starch,
inulin and low molecular weight non-digestible oligosaccharides (DP <
10). These methods do not measure all non-digestible carbohydrates with
a DP < 10. In contrast, newer methods (AOAC 2009.01 and AOAC 2011.25)
measure all low molecular weight non-digestible carbohydrates (i.e.,
non-digestible oligosaccharides) in addition to the higher molecular
weight non-digestible carbohydrates (Ref. 83). Thus, these newer, more
inclusive AOAC methods would be more consistent with our proposed
definition. However, there is no analytical method that can distinguish
non-digestible carbohydrates that have a beneficial physiological
effect from those that do not.
We are proposing to amend Sec. 101.9(c)(6)(i) to indicate that
dietary fiber content may be determined by subtracting the amount of
non-digestible carbohydrates added during processing that do not meet
the definition of dietary fiber (in proposed Sec. 101.9(c)(6)(i)) from
the value obtained using AOAC 2009.01, AOAC 2011.25 or an equivalent
AOAC method of analysis as given in the ``Official Methods of Analysis
of the AOAC International'' 19th Edition. If a product contains only
non-digestible carbohydrates that meet the proposed definition of
dietary fiber, using AOAC 2009.01, AOAC 2011.25, or an equivalent
method would be sufficient to quantify the dietary fiber content of a
food. However, if the product contains both dietary fiber that is
included in the proposed definition (e.g., naturally occurring fibers)
and non-digestible carbohydrates not included in the definition (e.g.,
synthetic fibers without a physiological effect that is beneficial to
human health), neither AOAC 2009.01 or AOAC 2011.25 nor an equivalent
AOAC method would accurately quantify the dietary fiber that could be
declared on the Nutrition Facts label, because the determination of
fiber by these methods would include the non-digestible carbohydrates
that do not meet the proposed definition of dietary fiber.
To verify that the quantity of dietary fiber declared on the
Nutrition Facts label includes only those fibers that

[[Page 11911]]

meet the regulatory definition of dietary fiber, when a food contains a
mixture of non-digestible carbohydrates that meet the proposed dietary
fiber definition and those that do not, we are proposing in Sec.
101.9(c)(6) and (g)(10) to require manufacturers to make and keep
written records to verify the amount of added non-digestible
carbohydrates that do not meet the proposed definition of dietary
fiber. See discussion in section II.N. Such records would provide
information to verify that the amount of dietary fiber declared meets
the proposed definition. The amount of non-digestible carbohydrate
measured by AOAC 2009.01 or AOAC 2011.25 (or an equivalent AOAC method)
minus the amount of added non-digestible carbohydrate that has not been
determined by FDA to have a physiological effect that is beneficial to
human health would reflect the amount of dietary fiber lawfully
declared on the label.
iv. DRV. The DRV for dietary fiber is 25g (Sec. 101.9(c)(9)). We
did not ask specific questions in the 2007 ANPRM and received no
comments on the DRV for dietary fiber. In 2002, the IOM set an AI of 14
g/1,000 kcal for ``total fiber'' (Ref. 66). The AI was primarily based
on the intake level that was associated with the greatest reduction in
the risk of CHD. We are proposing to define dietary fiber to include
those fibers that have a physiological effect that is beneficial to
human health (see section II.D.5.) and, as such, the AI for ``total
fiber'' provides an appropriate basis for setting a DRV for dietary
fiber declared on the Nutrition Facts label.
Therefore, we are proposing to use 14 g/1,000 kcal as the basis for
a DRV for dietary fiber. Using a reference calorie intake of 2,000
calories (see section II.A.3.), we are proposing to amend Sec.
101.9(c)(9) to set a DRV of 28 g (14g/1,000 kcal x 2,000 kcal/d) for
dietary fiber.
b. Soluble and Insoluble Fiber--Dietary fibers can be classified as
being soluble or insoluble. Soluble fibers, such as pectin and gums,
dissolve in water and are digested by the bacteria in the large
intestine. Insoluble fibers, such as cellulose and lignin, do not
dissolve in water and are not digested by bacteria in the large
intestine, adding bulk to the stool for improved laxation.
i. Definition. Like dietary fiber, FDA regulations do not establish
definitions for soluble or insoluble fiber. The 2007 ANPRM did not ask
questions about definitions for soluble and insoluble fiber and we did
not receive any comments about them. Because soluble and insoluble
fibers are components of dietary fiber, we tentatively conclude that
soluble and insoluble fibers must meet the proposed definition of
dietary fiber. Therefore, we are proposing in Sec. 101.9(c)(6)(i)(A)
and (c)(6)(i)(B) that soluble fiber and insoluble fiber, respectively,
must meet the definition of dietary fiber in paragraph 101.9(c)(6)(i).
ii. Voluntary declaration. FDA regulations permit, but do not
require, the declaration of soluble fiber (Sec. 101.9(c)(6)(i)(A)) and
insoluble fiber (Sec. 101.9(c)(6)(i)(B)) on the Nutrition Facts label.
In the 2007 ANPRM, FDA asked whether the declaration of soluble and
insoluble fiber should continue to be voluntary or made mandatory. We
considered comments received (Ref. 47).
While a quantitative intake recommendation is not available from
relevant U.S. consensus reports, there is well-established evidence
showing that soluble and insoluble fibers have distinct physiological
effects that are beneficial to human health. For example, the IOM noted
that the body of evidence indicates that non-fermentable fiber sources
(often isolated as insoluble fiber) promote laxation, and improved
laxation is an established physiological effect that is beneficial to
human health (Ref. 66). Therefore, we tentatively conclude that soluble
and insoluble fibers that meet the definition of dietary fiber have
public health significance and, in the absence of quantitative intake
recommendations, are consistent with the considerations for voluntary
declaration explained in section I.C. Accordingly, we are proposing to
continue to provide for the voluntary declaration of soluble and
insoluble fibers, as specified in Sec. 101.9(c)(6)(i)(A) and (B).
With respect to the term used to declare dietary fiber content on
the Nutrition Facts label, in 2001, the IOM Panel recommended that the
terms ``soluble'' and ``insoluble'' fiber be phased out and replaced
with relevant descriptors of the physicochemical properties of
particular fibers (e.g., ``viscous'' or ``fermentable'' fiber to
replace ``soluble'' fiber), as the characterization of the properties
of various fibers becomes standardized (Ref. 24). In the 2007 ANPRM, we
noted this recommendation and asked for public comment on whether the
terms ``soluble fiber'' and ``insoluble fiber'' should be changed to
``viscous'' and ``nonviscous'' fiber.
We considered the IOM recommendations as well as comments received
(Ref. 47), and tentatively conclude that the terms ``soluble fiber''
and ``insoluble fiber'' are most appropriate for reasons discussed in
this document. While the IOM recommended replacing ``soluble fiber''
and ``insoluble fiber'' with appropriate physicochemical terms as the
characterization of the properties of various fibers becomes
standardized, such standardization has not yet occurred. In addition,
as the comments stated, viscosity does not predict fermentability (Ref.
47), which the IOM recognized is a physicochemical property that is
linked to health benefits, and it is not known at what level of
viscosity a fiber begins to have a physiological effect (Ref. 66).
Moreover, there are no currently available scientifically valid methods
that FDA could use to measure the amount of various fibers defined by
their physicochemical properties in various food matrices, whereas
scientifically valid methods to measure soluble and insoluble fiber are
currently available. Therefore, we are not proposing any changes to the
use of terms ``soluble fiber'' and ``insoluble fiber'' in the Nutrition
Facts label.
iii. Analytical methods. Per FDA regulations, compliance with any
declaration of soluble or insoluble fibers is determined using
appropriate AOAC analytical methods (Sec. 101.9(g)(2)). While there
are a number of traditional AOAC methods available for measuring
soluble fiber (e.g., AOAC 991.43 and 993.19) and insoluble fiber (e.g.,
AOAC 991.42 and 991.43), as is the case with dietary fiber, these
methods cannot measure all non-digestible carbohydrates with a DP < 10.
A newer method, AOAC 2011.25 (Ref. 83), can measure low molecular
weight non-digestible carbohydrates, as well as separately measure
soluble and insoluble non-digestible carbohydrates. However, as in the
case of AOAC 2009.01, AOAC 2011.25 (Ref. 83) cannot distinguish soluble
and insoluble non-digestible carbohydrates that have a physiological
effect that is beneficial to human health from those that do not.
We are proposing to amend Sec. 101.9(c)(6)(i)(A) and (c)(6)(i)(B)
to indicate that the soluble and insoluble non-digestible carbohydrate
content may be calculated by first using AOAC 2011.25, or an equivalent
AOAC method of analysis. If a food contains only non-digestible
carbohydrates that meet the proposed definition of dietary fiber (e.g.,
contains naturally occurring fiber only), then AOAC 2011.25 or an
equivalent AOAC method would measure the amount of soluble or insoluble
fiber that can be declared on the Nutrition Facts label. If a food
contains a mixture of non-digestible carbohydrates that do and do not
meet the proposed dietary fiber definition, and the label of the food
declares soluble or insoluble fiber content, we are proposing to amend
Sec. 101.9(c)(6)(i)(A) and (c)(6)(i)(B) to

[[Page 11912]]

require manufacturers to make and keep records to verify the amount of
soluble or insoluble non-digestible carbohydrates that do not meet the
proposed definition of dietary fiber that have been added to the food
product during processing. (See discussion in section II.N.)
iv. DRV. FDA regulations do not establish DRVs for soluble fiber or
insoluble fiber. No DRIs were established for soluble or insoluble
fiber during the IOM's evaluation of a DRI for dietary fiber (Ref. 66),
and we have no basis on which to derive an appropriate DRV. Therefore,
we are not proposing to set a DRV for either soluble fiber or insoluble
fiber.
v. Caloric value. Per FDA regulations, the caloric content of a
food may be calculated by, among other methods, using the general
factors of 4, 4, and 9 kcal/g for protein, total carbohydrate less the
amount of insoluble dietary fiber, and total fat, respectively (Sec.
101.9(c)(1)(i)(C)). Accordingly, soluble fiber, which is encompassed
within ``total carbohydrate,'' is assigned a general factor of 4 kcal/
g. We did not ask questions about the caloric value of dietary fibers
in the 2007 ANPRM, but received a few comments on the caloric value of
soluble fiber, including that 4 kcal/g for soluble fiber was too high
and that we should consider 2 kcal/g, which is the caloric value
identified by the United Nations Food and Agriculture Organization. We
also received a citizen petition from the Calorie Control Council
requesting that the caloric value of soluble fiber be no more than 2
kcal/g (Docket No. FDA-1997-P-0232), based on the caloric contribution
of energy yielding short chain fatty acids that are produced as a
result of colonic fermentation of soluble fiber (https://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0232).
We agree with the comments and the petition supporting a caloric
value of 2 kcal/g for soluble fiber. The anaerobic fermentation of
soluble fibers in the colon has been shown to yield less energy than
the 4 kcal/g obtained from aerobic metabolism of carbohydrates (Ref.
66). In addition, the absorption of energy yielding short chain fatty
acids that are produced as a result of colonic fermentation of soluble
fiber can vary, and data indicate that the average energy yield from
soluble fibers is 1.5 to 2.5 kcal/g (Ref. 66). Therefore, we
tentatively conclude that 2 kcal/g is a reasonable estimate of the
caloric value of soluble non-digestible carbohydrates. Accordingly, we
are proposing to amend Sec. 101.9(c)(1)(i)(C) to establish a general
factor of 2 kcal/g as the caloric value of soluble non-digestible
carbohydrates. Insoluble non-digestible carbohydrates are not included
in the caloric calculation.
We are also proposing a corresponding change to the introductory
text in Sec. 101.9(c)(1)(i)(C) to exclude non-digestible carbohydrate
from total carbohydrate. FDA regulations require that the calories from
total carbohydrate be calculated by using the general factor of 4 kcal/
g of carbohydrate less the amount of insoluble dietary fiber (Sec.
101.9(c)(1)(i)(C)). We are proposing a new definition of dietary fiber
(see section II.D.5.a.i.) that only allows for the declaration of
dietary fibers that are added to foods that we have determined to have
a physiological effect that is beneficial to human health, as ``dietary
fiber'' on the Nutrition Facts label. Therefore, the proposed new
definition of dietary fiber would exclude soluble and insoluble non-
digestible carbohydrates that do not meet the proposed definition of
dietary fiber. For the purposes of calculating calories from soluble
non-digestible carbohydrate, the proposed factor of 2 kcal/g should
apply to those soluble non-digestible carbohydrates that both do and do
not meet the proposed definition of dietary fiber. To ensure that
soluble non-digestible carbohydrates that do and do not meet the
proposed definition of dietary fiber are excluded from total
carbohydrate, such that a general factor of 2 kcal/g is applied to
these non-digestible carbohydrates, we are proposing to amend Sec.
101.9(c)(1)(i)(C) to require that calories from carbohydrate be
calculated using a general factor of 4 kcal/g of total carbohydrate
less the amount of non-digestible carbohydrates, which includes soluble
and insoluble non-digestible carbohydrates that do and do not meet the
definition of dietary fiber (see also section II.D.1.f.).
6. Other Carbohydrate
FDA regulations define ``other carbohydrate'' as the difference
between total carbohydrate and the sum of dietary fiber, sugars, and
sugar alcohol, except that if sugar alcohol is not declared, ``other
carbohydrate'' is defined as the difference between total carbohydrate
and the sum of dietary fiber and sugars (Sec. 101.9(c)(6)(iv)).
Examples of ``other carbohydrate'' include starch and oligosaccharides.
A statement of the amount of ``other carbohydrate'' may be voluntarily
declared on the Nutrition Facts label (Sec. 101.9(c)(6)(iv)). We did
not ask questions about the labeling of ``other carbohydrate'' in the
2007 ANPRM, and we received no comments on this issue. However, we
reconsidered the provision for voluntary declaration of ``Other
carbohydrate'' on the Nutrition Facts label based on the factors we
consider for the mandatory and voluntary declaration discussed in
section I.C.
``Other carbohydrate'' represents different types of carbohydrate,
and, unlike sugars and dietary fiber, carbohydrates covered under this
heterogeneous category have no shared physiological effects. Moreover,
there is no well-established evidence to support the role of particular
types of carbohydrate that fall within the ``other carbohydrate''
category, such as starch and oligosaccharides, in human health that is
based on reliable and valid physiological or clinical endpoints. In
addition, a quantitative intake recommendation for ``Other
carbohydrate'' is not available from relevant consensus reports. Given
the lack of public health significance or a quantitative intake
recommendation for ``other carbohydrate'' as a category, consistent
with the factors discussed in section I.C., we tentatively conclude
that ``Other carbohydrate'' should no longer be permitted to be
declared on the Nutrition Facts label.
Therefore, we are proposing to remove current Sec. 101.9(c)(6)(iv)
to remove the provision that allows for the voluntary declaration of
``Other carbohydrate'' on the Nutrition Facts label. We are also
proposing to make a corresponding revision to Sec. 101.9(g)(4) and
(g)(6) to remove references to ``Other carbohydrates.'' We invite
comment on this issue, including any other data or factual information
that we should consider in making a final determination.

E. Protein

1. Mandatory and Voluntary Declaration
Section 403(q)(1)(D) of the FD&C Act requires food labeling to bear
nutrition information about protein. FDA regulations require the
declaration of the amount of protein by weight, and provide for
voluntary declaration of the percent DV for protein on the Nutrition
Facts label (Sec. 101.9(c)(7)(i)). In response to the 2007 ANPRM, one
comment supported the current approach, whereas another comment
recommended that FDA require the labeling of the percent DV for
protein.
We considered current scientific evidence and comments received
(Ref. 47). There is strong evidence based on valid physiological and
clinical endpoints that protein is an essential nutrient that is
necessary for human health and growth (Refs. 6 and 84). Therefore, we
tentatively conclude that the declaration of protein content

[[Page 11913]]

remains necessary to assist consumers in maintaining healthy dietary
practices. In addition, because protein intake in the U.S. population
continues to be adequate when compared to the EAR absent a mandatory
percent DV declaration (Ref. 85), we tentatively conclude that the
declaration of protein as a percent DV should remain voluntary.
Accordingly, we are not proposing any changes to the requirement for
declaration of the quantitative amount of protein and the voluntary
declaration of this amount as a percent DV on the Nutrition Facts
label.
2. Analytical Methods
Under Sec. 101.9(c)(7), protein may be calculated on the basis of
6.25 times the nitrogen content of the food determined by the
appropriate method of analysis as given in the Official Methods of
Analysis of AOAC International, 15th ed. (1990), except when the
official procedure for a specific food requires another factor. On
December 21, 2000, we received a citizen petition from Protein
Technologies International, Inc. (FDA-2000-P-0569), requesting that FDA
amend the reference to the method used to calculate protein content
found in Sec. 101.9(c)(7) to read ``the appropriate method of analysis
as given in the Official Methods of Analysis of the AOAC International,
17th ed. (2000)'' (https://www.regulations.gov/#!docketDetail;D=FDA-
2000-P-0569). The petition explained that the only approved method for
use in human food in the 15th edition of the AOAC Official Methods of
Analysis was the Kjeldahl method, which the petition stated involves
the use of a mercury catalyst and, therefore, can be potentially
harmful to humans and the environment. The petition asserted that the
17th edition of the AOAC Official Methods of Analysis recognized an
alternative method, the Combustion method, also known as the Dumas
method, to measure protein levels in some human foods and that we
should permit its use for measuring protein content.
We note that not all Kjeldahl methods included in the Official
Methods of Analysis of the AOAC contain a mercury catalyst.
Furthermore, the Kjeldahl method is a well-recognized, standard method
for determination of protein content. In fact, it is the method cited
for use in determination of protein digestibility in the ``Protein
Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on
Protein Quality Evaluation'' (Ref. 86) that is incorporated by
reference in Sec. 101.9(c)(7)(ii).
As discussed in section II.N.2., we see a need to update the
version of the Official Methods of Analysis of the AOAC International
that we use for compliance purposes because newer, and sometimes
better, analytical methods for many nutrients are included in versions
of the methods that have been published since the 15th edition. We are,
therefore, proposing to amend Sec. 101.9(c)(7) to incorporate by
reference the Official Methods of Analysis of the AOAC International,
19th ed. (2012) by removing ``15th Ed. (1990)'' and adding in its place
``19th Ed. (2012).'' The 19th edition is the most recent edition of the
published AOAC methods, and includes both the Kjeldahl and the
Combustion/Dumas methods. While the petition requested that the Agency
amend Sec. 101.9(c)(7) to incorporate the 17th edition of the AOAC
methods, the 19th edition includes all of the methods for protein that
were available in the 17th edition. Thus, the proposed action is
consistent with the petition's request. If a newer version of the
Official Methods of Analysis of the AOAC International is published
before publication of the final rule (assuming that this rulemaking
does result in a final rule), we will consider, as appropriate, using
the most recent version of the official AOAC methods in the final rule.
To the extent that the methods for protein determination in the newer
version differ from those provided in the 19th edition of the Official
Methods of Analysis of the AOAC International, we will consider the
need to seek additional public comment on the version of the AOAC
Methods of Analysis of the AOAC International that is incorporated by
reference in Sec. 101.9(c)(7).
3. DRV
The DRV for protein is 50 g (Sec. 101.9(c)(9)) and represents 10
percent of the 2,000 reference calorie intake level. The IOM Labeling
Committee considered the IOM's AMDR for protein (10 to 35 percent of
energy intake for adults) and the AMDRs for fat and carbohydrates, and
recommended setting the DV for protein based on the difference between
total energy intake and the combined DVs for fat and carbohydrate
(i.e., 100 percent of energy - (DVfat +
DVcarbohydrate). The 2007 ANPRM requested comment on whether
the DV for protein should be based on (1) the approach recommended in
the IOM Labeling Report; (2) the midpoint of the AMDR for protein
(i.e., 22.5 percent); or (3) the EAR or RDA for protein. We received
comments on each of these approaches (Ref. 47). Overall, comments
supported the approach recommended in the IOM Labeling Report and
maintaining the DV of 50 g/d.
We considered current scientific recommendations and agree with the
comments that supported the continued use of the current approach.
First, as explained in sections II.B. and II.D., we are not proposing
to change the DRVs for fat (30 percent of calories from fat or 65 g) or
carbohydrate (60 percent of calories from carbohydrate or 300 g).
Applying the IOM Labeling Committee's recommended approach, given our
tentative conclusions on DRVs for fat and carbohydrates, that approach
would result in no change to the DRV for protein, i.e., 10 percent (100
- (60 + 30)) of calories from protein.
Second, at 10 percent of caloric intake and using a reference
energy intake of 2,000 calories, the DRV for protein is set at 50 g,
which is relatively close to the IOM's RDAs for men and women. The
RDAs, which represent values that meet the needs of almost all (97 to
98 percent) individuals in a group, are set at 0.80 g/kg for men and
women who are 19 years and older, 0.85 g/kg for boys and girls 14 to 18
years of age, and 0.95 g/kg for boys and girls 4 to 13 years of age.
Using reference weights established for age and gender groups, the
resulting values are 56 g/d for males and 46 g/d for females who are 19
years of age or older (not including pregnant and lactating women), 52
g/d for males and 46 g/d for females between the ages of 14 through 18
years of age, 34 g/d for males and females between the ages of 9 and 13
years, and 19 g/d for males and females between the ages of 4 through 8
years. Thus, the DRV of 50 g for protein falls within the range of the
RDAs calculated using reference weights.
We do not consider the midpoint of the AMDR of 22.5 percent of
energy intake to provide the most appropriate basis for a DRV for
protein. We have no data to show that protein intakes are inadequate or
that setting a higher DRV that is based on the midpoint of the AMDR is
needed to prevent chronic diseases such as cardiovascular disease,
obesity, and sarcopenia, as asserted by some comments (Ref. 47). The
AMDR is a range of intakes for a particular energy source that is
associated with reduced risk of chronic diseases while providing
adequate intakes of essential nutrients (Ref. 20). The DRV of 10
percent of calories from protein falls within the AMDR. Thus, the DRV
for protein falls within a range of protein consumption that is
associated with a reduced risk of chronic disease while providing
essential nutrients.

[[Page 11914]]

Finally, we consider the use of the population-weighted EAR to be
inappropriate. First, as the comments pointed out (Ref. 47), using the
population-weighted EAR could lead to inadequate consumption in some
subpopulations, such as males 19 years and older. In addition, the EARs
for protein are expressed in terms of g/kg of body weight and based on
consumption of good quality or ``complete'' protein. In order to
calculate a DRV from the population-weighted EAR for the purposes of
nutrition labeling, a reference body weight would have to be selected.
Although we could use the EER predictive equations included in the
IOM's DRI macronutrient report (Ref. 50) to determine a reference body
weight, these values may be inappropriate for the general U.S.
population, which has a high percentage of overweight individuals. The
IOM Labeling Report stated that deriving a label reference value for
protein based on values from the EER predictive equations may not be
appropriate for large segments of the North American population for the
same reason (Ref. 25).
Therefore, we tentatively conclude that the DRV for protein should
continue to be based on 10 percent of calories. Accordingly, we are not
proposing to change the DRV of 50 g for protein.

F. Sodium

1. Mandatory Declaration
FDA regulations require the declaration of sodium content on the
Nutrition Facts label (Sec. 101.9(c)(4)). The 2007 ANPRM did not ask
any questions about the mandatory declaration of sodium, but one
comment that recommended the declaration of sodium should remain
mandatory because the information can help consumers who are concerned
about sodium and salt make appropriate food choices.
Americans 4 years and older consume an average of approximately
3,650 mg sodium/d (NHANES 2003-2006), which is more than twice the
amount required to meet their adequate intake (1,500 mg/day for
individuals 9 to 50 years old). Evidence continues to support the
association between increased sodium consumption and increased blood
pressure. In 2005, the IOM noted the direct relationship between sodium
intake and increased blood pressure (Ref. 10). The 2010 DGAC and the
2013 IOM committee on Sodium Intake in Populations (Ref. 87) concluded
that a strong body of evidence has been documented in adults that as
sodium intake decreases, so does blood pressure (Ref. 30). We agree
with the comment that information about sodium content on the food
label can help consumers make appropriate food choices.
Therefore, we tentatively conclude that declaration of sodium
should remain mandatory so consumers are provided information necessary
to assist them in maintaining healthy dietary practices. Accordingly,
we are not proposing to amend the current requirement for declaration
of sodium in Sec. 101.9(c)(4).
2. DRV
a. Need to update the DRV--The DRV for sodium is 2,400 mg (Sec.
101.9(c)(9)). New scientific data and consensus reports on sodium
published since the 1993 final rule (58 FR 2206 at 2224) highlight the
need to reconsider the DRV. Recent key consensus reports and
recommendations that FDA reviewed in reconsidering the DRV are as
follows:
i. IOM DRI Electrolytes Report. In 2005, the IOM established AIs
and ULs for sodium (Ref. 10). The IOM found that data from dose-
response trials for determining the daily requirement for sodium were
insufficient to establish an EAR for sodium and, thus, an RDA could not
be determined and an AI was set. The AIs for sodium are intake levels
that meet or exceed the daily nutrient requirement, i.e., the
recommended daily average intake levels that are needed to meet the
sodium needs of most healthy and moderately active individuals, are
1,500 mg/d for individuals 9 to 50 years, 1,300 mg/d for individuals 51
to 70 years, and 1,200 mg/d for individuals older than 70 years and for
children 4 to 8 years of age. AIs meet or exceed the intake levels
required to meet nutrient needs and there is no benefit in consuming a
nutrient in excess of its AI.
Data available to the IOM showed that; (1) a carefully planned diet
that provided an average of approximately 1,500 mg/d of sodium can meet
recommended intakes of other nutrients; (2) 1,500 mg/d exceeds the
levels of sodium intake that have been associated with effects of
inadequacy, such as adverse effects on blood lipid concentrations and
insulin resistance; and (3) 1,500 mg/d allows for sodium sweat losses
in acclimatized individuals who are exposed to high temperatures or who
become physically active. The AI does not apply to individuals who are
highly active and workers who are exposed to heat stress that lose
large volumes of sodium in sweat (Ref. 10).
ULs are the highest level of daily nutrient intake that is likely
to pose no risk of adverse health effects to almost all individuals in
the general population (Ref. 10). The major adverse and dose-dependent
effect of increased sodium intake is elevated blood pressure and the
IOM noted that the relationship between sodium intake and blood
pressure is continuous, making it difficult to set a precise UL because
other environmental factors (weight, exercise, potassium intake,
dietary pattern, and alcohol intake) and genetic factors also affect
blood pressure. The ULs for sodium are 2,300 mg/d for all individuals
ages 14 years and older, 1,900 mg/d for children 4 to 8 years old, and
2,200 mg/d for adolescents 9 to 13 years old. The UL is not intended to
be a recommended intake level to encourage, but rather a level not to
exceed.
The IOM stated that the UL may be lower than 2,300 mg/d among
certain groups who are at increased risk of the blood pressure-raising
effects of increased sodium intake (e.g., older individuals, African
Americans, and individuals with hypertension, chronic kidney disease,
or diabetes), but insufficient data prevented IOM from defining a
specific UL for these groups. Instead, the IOM set the same UL for
these population groups as the one for the general population (i.e.,
2,300 mg/d), with the acknowledgment that the actual UL for this group
may be lower.
ii. IOM Report on the Strategies to Reduce Sodium Intake in the
United States (IOM Sodium Strategies Report). After considering current
trends in hypertension, sodium consumption, sodium content of the food
supply, and existing strategies for sodium reduction, the IOM developed
various strategies for reducing dietary sodium intake to levels
recommended by the 2005 DGA. Among various recommendations to
Government Agencies, food manufacturers, consumers, and other
stakeholders, the IOM recommended that FDA adopt 1,500 mg as the DV for
sodium, given that sodium is an essential nutrient and that, unlike in
1993 (58 FR 2206 at 2224), a reference value of adequacy is now
available (i.e., the AI of 1,500 mg/d).
iii. 2010 DGA. The 2005 DGA made a key recommendation for the
general U.S. population to consume less than 2,300 mg/d of sodium and
that individuals with hypertension, African-Americans, and middle-aged
and older adults should aim to consume no more than 1,500 mg/d of
sodium (Ref. 36). In 2010, the DGAC evaluated evidence considered in
the 2005 DGAC report in addition to new research on the relationship
between sodium intake and blood pressure, focusing on the strength of
the scientific evidence (Ref. 30). The 2010 DGAC report noted that
1,500 mg/d should be the intake goal for the

[[Page 11915]]

general U.S. population. Further, the DGAC noted that, given the
current U.S. marketplace and the resulting excessively high sodium
intake, it will be challenging to achieve the lower level. The 2010
DGA, considering the 2010 DGAC conclusions, recommended a reduction in
sodium intake to less than 2,300 mg/d and a further reduction to 1,500
mg/d among African Americans, individuals with hypertension, diabetes,
or chronic kidney disease, and individuals ages 51 years or older.
iv. IOM Report on Sodium Intake in Populations, Assessment of
Evidence, 2013 (Ref. 87). The charge to the committee focused on
literature published since 2003, therefore they reviewed literature
between 2003 and 2012. The committee assessed the benefits and adverse
outcomes (if any) of reducing sodium intake, particularly in the range
of 1,500 to 2,300 mg/d, with an emphasis on the subgroups known to be
at increased risk of the blood pressure-raising effects of increased
sodium intake. Based on the review of studies that assessed
cardiovascular events and mortality, the committee found that evidence
from studies on direct health outcomes is inconsistent and insufficient
to conclude that lowering sodium intakes below 2,300 mg/d will increase
or decrease the risk of CVD outcomes or all-cause mortality in the
general U.S. population. The committee also concluded that the evidence
from direct health outcomes does not support recommendations for
subgroups (people with diabetes, chronic kidney disease and pre-CVD) to
lower their sodium intake to or even below 1,500 mg/d. No relevant
evidence was found on health outcomes for the other population
subgroups considered (i.e., African Americans and persons 51 years of
age and older).
b. CSPI petition--In 2005, we received a citizen petition from CSPI
(2005 CSPI petition) requesting, among other sodium related issues,
that FDA initiate rulemaking to reduce the DRV for sodium from 2,400 to
1,500 mg (Docket No. FDA-2005-P-0196 (formerly Docket No. 2005P-0450))
(https://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0196). Citing
the 2005 DGA, the petition requested that FDA adopt a DV of 1,500 mg
because that is the recommended maximum intake for roughly one-half of
the adult population (i.e., people with hypertension, African-
Americans, and middle-aged and older people). According to the
petition, when recommended intake levels vary among population groups,
FDA has typically been conservative, choosing a DV that is most
protective. In this proposed rule, we are responding to the petition's
request to reduce the DRV for sodium from 2,400 mg to 1,500 mg. The
petition's other requests are outside the scope of this rulemaking.
c. Comments to 2007 ANPRM--In the 2007 ANPRM, we asked whether a
new DV for sodium should be based on the UL or on the AI. We also asked
whether the UL, were it to be used, should reflect the same approach
(population-weighted or population-coverage) as the other DRIs. While a
few comments supported retaining the current DRV of 2,400 mg, the
majority of comments supported using the UL of 2,300 mg/d. Some other
comments recommended setting a DV for sodium based on the AI of 1,500
mg/d. One comment urged that we adopt a tiered two-phase, step-down
approach establishing an interim DRV of 2,000 mg in 2013 and a final
revised DRV of 1,500 mg by 2020. See also (Ref. 47).
d. Options Considered--When the Nutrition Facts label was developed
in the early 1990s, no RDA or Estimated Safe and Adequate Daily Dietary
Intake (ESADDI) levels were available for consideration. While the
National Academy of Sciences established 500 mg/d as an estimated
minimum requirement for healthy adults in 1989, the Agency relied on
the recommendation from 1989 National Research Council Report Diet and
Health: Implications for Reducing Chronic Disease Risk (Ref. 88) that
provided a quantitative intake recommendation for salt, based on blood
pressure, that was equivalent to 2,400 mg/d as a value that consumers
should not exceed (58 FR 2206 at 2223, 2224). There is debate in the
scientific community about the appropriate DV for sodium, taking into
account its essentiality in relatively small amounts as well as its
association with increased blood pressure at greater but varying levels
of intake.
Current recommendations recognize the benefits of reduced sodium
intake in the general population, despite the heterogeneity among
individuals in blood pressure responses to changes in sodium intake.
Although several factors influence inter-individual variability in
blood pressure responses to changes in dietary sodium, certain
population groups have been reported to have a higher prevalence of
salt sensitivity and are considered to be most at risk of sodium-
related chronic disease. Salt sensitivity is the extent of change in
blood pressure in response to a change in salt intake (Ref. 10). Salt
sensitivity differs among subgroups of the population as well as among
individuals within a subgroup. Subgroups that have been reported to
have a high prevalence of salt sensitivity include individuals 51 years
of age and older, African Americans, and individuals with hypertension,
diabetes or chronic kidney disease. The 2010 DGA recommended that
Americans reduce sodium intakes and also noted that these population
subgroups, representing nearly half of the U.S. population, would
benefit from even greater reductions in sodium intake than the general
population. We have considered the challenges related to lowering the
DV for sodium. For example, lowering the value on which the percent DV
declaration is based would likely require efforts to ensure consumer
understanding of the new percent DV declaration of sodium on the
Nutrition Facts label. Based on recent dietary recommendations from
consensus reports, currently available scientific evidence, comments in
response to the 2007 ANPRM, and the 2005 CSPI petition, we considered
the following options for updating the DV for sodium:
(1) A DRV of 2,300 mg which reflects the UL for individuals aged 14
years and older;
(2) An RDI of 1,500 mg which reflects the AI for individuals 9 to
50 years of age; and
(3) Alternative approaches such as retaining a DRV of 2,400 mg,
using a tiered approach or setting a DRV of 1,900 mg based on the UL
for children 4 to 9 years of age.
i. DRV of 2,300 mg/d. A DRV of 2,300 mg, which represents the UL
for the majority of the population (persons 14 years of age and older),
would be consistent with both the 2005 and 2010 DGA recommendations for
sodium intake for the general population, as well as the 2013 IOM
report on Sodium Intake in Populations. However, while a DRV of 2,300
mg would reflect the UL that is applicable to 88 percent of the U.S.
population, including those who are susceptible to the blood pressure-
raising effects of sodium, it would exceed the UL for children 4 to 13
years of age which is 1,900mg/day for children 4-8 years of age and
2,000mg/day for children 9-13 years of age.
Setting the DV at 2,300 mg would classify the level as a DRV
(rather than an RDI) and represent a reference intake level not to
exceed. As such, it would be consistent with our current and proposed
approach to using DRVs for other nutrients that should be limited in
the diet and for which there are concerns of excess intake and risk of
chronic disease or health-related conditions, for example, saturated
fat

[[Page 11916]]

and cholesterol. The current and proposed DRVs for saturated fat and
cholesterol are based on quantitative intake recommendations and
underlying science that links the excess intake of these nutrients to
specific adverse health effects (Ref. 6) (see sections II.B.2 and
II.C.). We do note, however, that unlike saturated fat and cholesterol,
sodium is an essential nutrient and, in the DRI Electrolytes report,
the IOM established an AI for sodium.
Results from the FDA Health and Diet Surveys have shown that
consumers are aware that too much sodium is unhealthy (Refs. 39 to 41)
and this awareness would suggest consumer acceptance of a DV based on a
level not to exceed would be consistent with a DRV of 2,300 mg.
Changing the DRV from 2,400 mg to 2,300 mg would likely result in less
consumer confusion than changing the DRV to an RDI (a level to achieve)
of 1,500 mg. Moreover, we have no data to suggest that lowering the
reference value for the percent DV could result in consumer confusion,
as claimed by a commenter (Ref. 47).
ii. RDI of 1,500 mg. An RDI of 1,500 mg, based on the highest AI
(i.e., among adults aged 19 to 50 years), would provide a daily average
intake level that would reflect a low prevalence of inadequate sodium
intakes of healthy and moderately active individuals while allowing for
adequate intakes of other essential nutrients. As opposed to 2,300 mg,
a DV of 1,500 mg would classify the level as an RDI representing a
reference intake level to achieve. The 2005 IOM electrolytes report
reviewed the evidence on low sodium intake and blood lipid
concentrations and insulin resistance and noted that the AI of 1,500
mg/d exceeds the levels of sodium intake (typically less than 700 mg/d)
that have been associated in some studies with adverse effects of blood
lipid concentrations and insulin resistance (Ref. 10). The 2005 IOM
electrolytes report reviewed the evidence for plasma renin and
concluded that, in contrast to blood pressure, there is no consensus on
the interpretation of plasma renin activity and its role in guiding
therapy for high blood pressure (Ref. 10). Similar to plasma renin
activity, the evidence for the role of sympathetic nerve activity and
aldosterone is limited, and therefore neither is recognized as
surrogate endpoints for CVD risk. Therefore, the AI of 1,500 mg/d
exceeds the levels associated with low sodium intake and the previously
discussed adverse effects.
Using the population-coverage AI to set the RDI for sodium would be
consistent with the proposed RDIs for other essential vitamins and
minerals for which AIs are established (e.g., vitamin K and choline)
(see section II.I.). AIs are similar to RDAs in that they meet the
needs of essentially all members of the population. Thus, using an AI
as a quantitative intake recommendation for setting an RDI would be
consistent with the proposed RDIs for other essential minerals that
have AIs or RDAs, such as potassium and calcium. Traditionally, we have
based the RDI for essential nutrients on quantitative intake
recommendations that reflect the intake level necessary to meet the
daily physiological needs for that nutrient. However, unlike the
consumption of other vitamins and minerals, the majority of the
population consumes sodium at levels that exceed the AI and the UL.
This makes sodium unique in comparison to other vitamins and minerals
for which people generally must strive to meet their daily needs.
In addition, an RDI of 1,500 mg would be consistent with the 2010
IOM Sodium Strategies Report (Ref. 89). The IOM recommended that FDA
base the DV for sodium on the AI of 1,500 mg/d. First, the IOM stated
that using the AI is consistent with the approach used for all other
essential nutrients, where the DV is based on a reference value of
adequacy rather than a reference value of safety. Second, although
consumer data were not provided, the IOM strategies report argued that
the use of the AI could better inform consumers of the actual
contribution of sodium content to total sodium needs as an essential
nutrient. Third, the IOM stated that adopting the AI would avoid
misleading consumers into thinking that the sodium content of foods is
more favorable than is actually the case. As such, from a public health
perspective, the AI would provide a truer picture for the consumer of
the contribution of the particular foods in assembling a healthful diet
and is preferable for this purpose over the UL. Finally, the IOM opined
that lowering the DV might act as an incentive for companies to reduce
the sodium content of their foods because reducing the DV would result
in a higher value of percent DV declared on the label if sodium content
remained unchanged.
The 2013 IOM Sodium Intake in Populations Committee concluded that
the evidence was insufficient and inconsistent to recommend sodium
intake levels below 2,300 mg/d for the general U.S. population based on
the direct outcomes of CVD or all-cause mortality. While this
recommendation does not address blood pressure or essentiality, it
provides a level that the general population should seek to reduce
their consumption to and therefore is a consideration in our proposal.
ANPRM comments pointed out challenges related to the feasibility of
achieving a DV of 1,500 mg given the current marketplace and patterns
of sodium consumption as well as changes in our nutrient content
claims. If we were to adopt a DV of 1,500 mg, we anticipate that
consumer education efforts would be needed to help consumers understand
that the updated DV for sodium is a level to achieve rather than a
level to consume less than and also that consuming in excess of this
level would not be helpful. Additionally, the IOM set the AI, in part,
at a level that would allow individuals to meet the recommended intakes
of other nutrients if they adopted a carefully planned diet (Ref. 10)
and consumer education efforts would need to communicate that 1,500 mg/
d is a level that consumers should achieve rather than not exceed.
While the Agency is considering ways to support the reduction of sodium
in the food supply (76 FR 57050), significant changes in the food
supply would be needed to achieve this goal.
An updated DV for sodium based on 1,500 mg/d would perhaps
necessitate revising other relevant regulatory requirements such as
nutrient content claims, however such revisions would be less likely if
the DV was updated to 2,300 mg. Previously, our decision to retain the
sodium level for a ``healthy'' claim (Sec. 101.65) at 480 mg/reference
amount customarily consumed (RACC) was based, in part, on technological
barriers and product acceptance issues by consumers with the more
restrictive level of 360 mg/RACC (70 FR 56828; September 29, 2005). We
acknowledge concerns from comments that consumers may find it difficult
to reduce dietary sodium levels to 1,500 mg/d.
iii. Alternative approaches.
A few comments suggested retaining 2,400 mg as the DRV for sodium.
Retaining the DRV of 2,400 mg would exceed the UL for sodium for the
entire population and there is no scientific evidence to support this
level. Therefore, we do not consider 2,400 mg an appropriate DRV for
sodium going forward. Also, based on ANPRM comments, we considered
setting an interim DRV of 2,300 mg that would be further lowered to an
RDI of 1,500 mg over time, providing companies a longer time to
manufacture new foods or reformulate existing products to lower the
sodium content. This approach would address concerns regarding the
feasibility of individuals being able to meet an RDI of 1,500 mg given
taste

[[Page 11917]]

preferences and sodium content of foods in the current marketplace. A
tiered approach would help to gradually achieve the adequate intake
level of 1,500 mg/d and would give manufacturers time to develop lower
sodium products and for consumers to adjust their taste preferences. In
addition, this approach would be consistent with the 2010 DGAC
recommendations which suggested that reduction in sodium intakes to
1,500 mg/d among Americans should occur gradually over time to allow
for adjustments in taste perceptions and to accompany changes in the
sodium content of foods in the marketplace.
We tentatively conclude that there is inadequate justification in
consensus reports or arguments presented by comments (Ref. 47) to
propose a tiered option. While levels of sodium intake may need to
decrease gradually due to time needed for modifications to the sodium
content of the food supply and consumer taste preferences, the DV for
sodium should reflect an amount that will assist consumers in
maintaining healthy dietary practices and in understanding the relative
significance of the percent DV for a particular food in the context of
the total daily diet. Moreover, DVs are based on scientific data
supporting healthy dietary practices, not on the levels of a nutrient
present in the food supply.
We also considered using 1,900 mg/d, the UL for children 4 to 8
years of age, to set the DRV for sodium. Using the lowest UL for a
population above 4 years of age is consistent with the population-
coverage approach discussed in section II.1.5. In this case, it is a
population-coverage approach that is protective for the age and gender
subpopulation with the lowest relative UL, providing an intake level
that is likely to pose no risk for any age or gender subpopulations.
This is in contrast to the population-coverage approach, using the RDA
or AI for other essential vitamins and minerals, to ensure that all age
and gender subpopulations consume adequate amounts. However, a DRV of
1,900 mg is not aligned with any recommendations from consensus reports
including the 2010 IOM Sodium Intake in Populations and was not
suggested by any comments.
e. Proposed DV--After considering the options discussed previously,
we are proposing to set a DRV of 2,300 mg for sodium based on the UL
for individuals ages 4 years of age and older (proposed Sec.
101.9(c)(8)(iv)). First, a DRV of 2,300 mg would be consistent with the
current sodium intake recommendations from consensus reports. Second, a
DRV of 2,300 mg would be consistent with our current and proposed
approach for other nutrients that should be limited in the diet and for
which there are concerns of excess intake and risk of chronic disease
and health-related conditions. Third, consumers are generally aware
that too much sodium is not healthy and therefore the current consumer
education messaging is consistent with a DRV of 2,300 mg.
For the reasons explained previously, we tentatively conclude that
a DRV of 2,300 mg for sodium is the most appropriate DV to assist
consumers in maintaining healthy dietary practices and in understanding
the relative significance of the sodium content within the context of a
total daily diet. We invite comment on our consideration of various
options and tentative conclusions presented in this section. In
particular, we invite comment on: (1) The rationale for the proposed
DRV of 2,300 mg of sodium; (2) whether an RDI of 1,500 mg would be more
appropriate and why; and (3) whether any alternative approaches for
selecting a DV for sodium and their public health bases for these
approaches could be more appropriate and why. We are also interested in
data and factual information on consumer understanding, interpretation,
and use of the percent DV of sodium declared on food labels, including
the understanding and potential influences of a DV that reflects an RDI
based on an AI (an intake level to not consume less of), instead of a
DRV based on a UL (an intake level not to exceed).

G. Fluoride

1. Voluntary Declaration
FDA regulations do not require or permit the declaration of
fluoride on the Nutrition Facts label. In 1993, no U.S. consensus
report had set a quantitative intake recommendation for fluoride. The
2007 ANPRM did not ask questions regarding the declaration of fluoride,
but several comments supported the voluntary declaration of fluoride in
mg or mcg amounts (Ref. 47). We are considering in this proposed rule
whether fluoride should be required or permitted to be declared or
whether the lack of provisions should be maintained.
Fluoride is a nonessential nutrient, but there is well established
evidence for the role of fluoride in reducing the risk of dental caries
(Ref. 90). The IOM set a quantitative intake recommendation for
fluoride based on its role in the reduction of risk of dental caries.
Additionally, in 2006, a FDAMA notification for a health claim for
fluoride in bottled water and dental caries was submitted to us under
section 403(r)(2)(G) of the FD&C Act (Ref. 91). We did not object to
the notification, indicating that we considered the evidence submitted
to be sufficient for bottled water that meets the standards of identity
and quality set forth in Sec. 165.110 and the general requirements for
health claims in Sec. 101.14 to bear the claim (Ref. 91). Given that
the positive health effects of fluoride are well-established, we
tentatively conclude that declaration of fluoride content of a food can
provide consumers with information to assist them in maintaining
healthy dietary practices. However, as discussed in section II.G.2., a
DRV cannot be established based on available quantitative intake
recommendations. Thus, while fluoride is a nutrient with public health
significance, an appropriate quantitative intake recommendation is not
available for setting a DRV.
Therefore, consistent with the factors we consider for declaration
of non-statutory nutrients discussed in section I.C., we are proposing
to amend Sec. 101.9(c)(5) to provide for voluntary declaration of
fluoride. In addition, consistent with existing provisions for
voluntary declaration of other nutrients, we are proposing that the
declaration of fluoride would be mandatory when a claim about fluoride
is made on the label or in labeling of foods. We are also proposing
that when fluoride content is declared, it must be expressed as zero
when a serving contains less than 0.1 mg of fluoride, to the nearest
0.1 mg increment when a serving contains less than or equal to 0.8 mg
of fluoride, and the nearest 0.2 mg when a serving contains more than
0.8 mg of fluoride, consistent with how we have approached incremental
values for other nutrients that are present in food in small amounts.
2. DRV
FDA regulations do not provide an RDI or DRV for fluoride. The 2007
ANRPM discussed the DRIs for fluoride and asked whether we should
establish a DV, given the availability of an AI. We considered current
recommendations and scientific evidence as well as comments received
(Ref. 47).
In 1997, the IOM established DRIs (AIs and ULs) for fluoride (Ref.
90). The AI was set at 3 mg/d for women 19 years and older and 4 mg/d
for men 19 years or older, to represent the intake value that reduces
the occurrence of dental caries maximally in a group of individuals
without causing unwanted side effects. AIs for children are 0.7 mg/d (1
through 3 years), 1 mg/d (4 through

[[Page 11918]]

8 years), and 2 mg/d (9 through 13 years). In addition, the IOM set a
UL for fluoride at 10 mg/d (0.1 mg/kg/d) for individuals older than 8
years, based on data that suggest that increased risk of developing
early signs of skeletal fluorosis is associated with fluoride intakes
greater than 10 mg/d. The UL for children 4 through 8 years is 2.2 mg/d
based on risk of developing moderate enamel fluorosis.
A recent report highlighted the potential adverse impact of excess
fluoride intake (Ref. 92). These adverse impacts include moderate
enamel fluorosis in children up to 8 years and skeletal fluorosis for
individuals older than 8 years. In 2010, the Environmental Protection
Agency (EPA) published a report on exposure of fluoride from various
sources. This report provided a benchmark of no more than 0.08 mg/kg/d
of total fluoride intake to protect 99.5 percent of the population from
severe dental fluorosis (Ref. 92). These benchmark levels (e.g., 1.68
mg/d for 4 to 7 years; 2.56 mg/d for 7 to 11 years; 4.08 mg/d for 11 to
14 years of age; and 5.6 mg/d for adults) are considerably lower than
the ULs set by IOM in 1997.
Thus, although the IOM set AIs for fluoride based on its role in
reducing the risk of dental caries, more recent conclusions have
highlighted concern about dental fluorosis associated with excess
intakes. Because an RDI of 4 mg, using the population-coverage AI of 4
mg/d, exceeds or is equivalent to EPA's benchmark values for children 4
to 14 years of age (1.68 to 4.08 mg/d), we are not proposing to set a
DRV for fluoride.
We considered concerns expressed by comments that a DRV should not
be established because fluoride is not an essential nutrient. That
fluoride is not essential is not, in itself, a justification for not
establishing a DV for fluoride, because there is evidence demonstrating
that dietary fluoride exposure is beneficial to public health owing to
its ability to inhibit the development of dental caries in both
children and adults (Ref. 90). However, we are not proposing to set a
DRV for fluoride for other reasons as explained previously. We also do
not consider that the DRV for fluoride should be set at zero because of
concerns with adverse health effects and toxicity, as suggested by a
comment. The IOM established an AI for fluoride based on risk reduction
of dental caries. In addition, the ULs for children and adults that are
set based on dental and skeletal fluorosis are greater than zero.
Moreover, FDA regulations other than those related to nutrition
labeling are intended to prevent excessive addition of fluoride in
foods (Sec. Sec. 165.110 and 170.45).

H. Essential Vitamins and Minerals of Public Health Significance

In addition to sodium, a statutorily required nutrient, FDA
regulations require the declaration of four essential vitamins and
minerals, namely, vitamin A, vitamin C, calcium, and iron (Sec.
101.9(c)(8)(ii)). Vitamins and minerals that may be declared
voluntarily are vitamin D, vitamin E, vitamin K, vitamin B6,
vitamin B12, thiamin, riboflavin, niacin, folate, biotin,
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, chloride, and potassium. In
1993, we identified vitamins A and C, calcium, and iron for mandatory
declaration because we considered them to be nutrients of public health
significance based on their inadequate dietary intakes among specific
segments of the U.S. population and because they were identified as
nutrients of potential public health significance in consensus reports
(Refs. 88, 93 to 95) (58 FR 2079 at 2106). We continue to consider,
consistent with the rationale put forth in 1993, that a vitamin or
mineral's public health significance should be the key factor in
mandatory labeling (58 FR 2079 at 2106).
In this section of the proposed rule, we discuss essential vitamins
and minerals that are not expressly required to be declared by statute
(referred to as ``non-statutory''). We are using our discretion, as
described in this document, to propose mandatory declaration of certain
non-statutory essential vitamins and minerals and voluntary declaration
of others. Our tentative conclusions are based on an assessment of
scientific data available for these nutrients, and consideration of the
factors discussed in section I.C. (explained in this document). The
RDIs that we are proposing for the declaration of vitamins and minerals
are discussed in section II.I.
We conducted an analysis of available data to determine the public
health significance of non-statutory essential vitamins and minerals.
The 2010 DGA identified nutrients of public health concern for the
general U.S. population using criteria that are similar to factors that
FDA considered in its own analysis (Ref. 6). The factors and the
evaluation process used in our analysis, discussed in greater detail in
Ref. 48, incorporate whether a DRI (i.e., RDA or AI) is based on a
chronic disease risk (e.g., osteoporosis), a health-related condition
(e.g., high blood pressure), or a nutrient deficiency with clinical
significance (e.g., low iron storage leading to iron deficiency anemia)
and whether national survey data on nutrient intake, and/or, when
available, biomarkers of nutrient status, provide evidence of
inadequate intakes in the general healthy U.S. population (4 years of
age and older). Furthermore, we consider whether a substantial
prevalence exists in the general population of a chronic disease,
health-related condition, or nutrient deficiency with clinical
significance that was linked to the particular nutrient (e.g.,
potassium and risk of high blood pressure).
To estimate the prevalence of nutrient adequacy or inadequacy in
the U.S. population, we compared dietary intake data with the EAR or AI
(whichever is established by the IOM for a particular nutrient) (Ref.
96) and, when reliable biomarkers of nutritional status were available,
we compared the biomarker survey data with the data on adequacy of
nutrient intake. The use of reliable status biomarker data provides
assessments of nutrient status, independent of subjective factors
associated with assessing nutrient intake, such as underreporting of
food intake (Ref. 97 pp. 373, 513, 534, 602, and 606). In the 2007
ANPRM, we sought input on whether vitamin A, vitamin C, calcium, and
iron are still considered to be of public health significance; and (2)
whether there are other micronutrients of public health significance.
We received several comments in response to these questions (Ref. 47).
Based on our analysis of data, and considering the factors for
mandatory and voluntary declaration discussed in section I.C. and the
comments received, as discussed in this document, we are proposing to:
(1) With respect to essential vitamins and minerals that are currently
required to be declared, retain mandatory declaration of calcium and
iron and provide for voluntary declaration of vitamins A and C; and (2)
with respect to essential vitamins and minerals that are permitted to
be declared, require the declaration of potassium and vitamin D and
retain voluntary declaration of others. We discuss these proposed
changes in this document.
1. Essential Vitamins and Minerals That Are Mandatory
a. Calcium--Calcium content must be declared as a percent DV on the
Nutrition Facts label (Sec. 101.9(c)(8)(ii)). In 1993, we required the
declaration of calcium in nutrition labeling because: (1) There were a
limited number of calcium-rich foods in the food supply; (2) calcium
intakes in the United States were generally marginal; (3) adequate
calcium intakes are needed to allow for

[[Page 11919]]

optimal bone mass development during childhood and young adulthood (55
FR 29487 at 29501); and (4) calcium was identified as a nutrient of
public health significance in the 1990 IOM report (Ref. 95) and in
other consensus reports (Refs. 88,93,94) (58 FR 2079 at 2106). In
response to the 2007 ANPRM, many comments maintained that calcium is
still considered a nutrient of public health significance, especially
in bone development, and therefore should be retained as a mandatory
nutrient on the Nutrition Facts label.
Our analysis of NHANES (2003-2006) data shows that usual calcium
intakes among the U.S. population continue to be low. About 49 percent
of individuals ages 4 years and older have usual calcium intakes from
conventional foods below the EAR, and 37 percent have intakes from both
conventional foods plus supplements below the EAR (table 1). The 2010
DGA, too, recognized that low intakes of calcium are a public health
concern for the general U.S. population (Ref. 6). We are unable to
consider biomarker data because sensitive biochemical indicators
reflecting calcium nutritional status are lacking.
In setting DRIs for calcium, the IOM reviewed various endpoints
(e.g., bone health, cancer, cardiovascular disease and diabetes), and
bone health was the only endpoint with sufficient evidence to set a DRI
(Ref. 22). Therefore, the IOM set age- and gender-specific DRIs based
on the level of calcium intake consistent with bone accretion,
achieving and maintaining bone calcium balance, minimizing the degree
of bone loss, and reducing the risk of fracture in later stages of life
(Ref. 22). The DRIs for calcium assume adequate intakes of vitamin D, a
nutrient which is essential for promoting calcium absorption in the gut
and for maintaining adequate calcium levels in the blood (Ref. 22).
Building strong bones during childhood and adolescence can help prevent
osteoporosis (the most common bone disease) later in life. Adequate
calcium intakes are needed to allow for optimal bone mass development
during childhood and young adulthood and to decrease rate of bone loss
in adults (Ref. 22). An estimated 10 million Americans over 50 years of
age have osteoporosis, while another 34 million are at risk and an
estimated 1.5 million people suffer an osteoporotic-related fracture
each year (Ref. 98). Furthermore, based on 2005-2006 NHANES data, about
5.3 million older men and women in the United States have osteoporosis
at the femur neck, and 34.5 million more have osteopenia (low bone
mass) in the femur neck (Ref. 99).
In addition, we independently reviewed data related to calcium
intake and risk reduction of osteoporosis (Sec. 101.72) and authorized
two health claims for this association, signifying calcium's critical
role in the reduction of risk of this chronic disease in the general
healthy population.
In view of the benefits of adequate calcium intake on bone health,
reflected in the IOM's DRIs, relatively low intakes of calcium, and the
high prevalence of osteoporosis and osteopenia among the U.S.
population, we tentatively conclude that calcium is a nutrient of
public health significance and its declaration continues to be
necessary to assist consumers in maintaining healthy dietary practices.
Therefore, consistent with the factors we consider for mandatory
declaration of non-statutory nutrients (see section I.C.), we are not
proposing any changes to the current requirement for declaration of
calcium on the Nutrition Facts label, as specified in Sec.
101.9(c)(8)(ii).
b. Iron--Iron must be declared as a percent DV on the Nutrition
Facts label (Sec. 101.9(c)(8)(ii)). In 1993, we required the
declaration of iron because (1) iron was identified as a nutrient of
public health significance in a 1990 IOM report (Ref. 95) and in other
consensus reports (Refs. 88,93,94); and (2) iron deficiency was a risk
for certain segments of the U.S. population (i.e., young children,
adolescents and women of childbearing age and pregnant women,
especially those with low incomes) (58 FR 2079 at 2106). In response to
the 2007 ANPRM, comments suggested retaining the mandatory declaration
of iron because it is a nutrient of concern for women of childbearing
age identified by the 2005 DGA (Ref. 36) and substantial numbers of
adolescent females and women of childbearing age are iron deficient.
Our analysis of NHANES (2003-2006) intake data shows that about 3.5
percent of the population ages 4 years and older (excluding pregnant
and lactating women) have inadequate iron intakes from conventional
foods (i.e., an intake below the EAR), and about 3.3 percent have
inadequate iron intakes from conventional foods and dietary supplements
(table 1). Subpopulation analyses of these NHANES 2003-2006 data shows
that about 11.2 percent of women of childbearing age (12 to 49 years of
age) continue to have intakes below the EAR, from conventional foods
only and 10.4 percent continue to have intakes below the EAR from
conventional foods plus dietary supplements (table 1).
We also considered data for several status biomarkers related to
iron nutrition, in addition to intake data. Serum ferritin is the major
iron-storage compound and its concentration declines in the early
stages of the development of iron deficiency (Refs. 100 and 101).
Although low serum ferritin concentration is an indicator of early iron
deficiency, it does not necessarily reflect the severity of iron
depletion as it progresses (Ref. 101). In addition to determining serum
ferritin, when relevant NHANES data were available, we also considered
iron deficiency based on estimating stored body iron using the ferritin
model and the body iron model (Ref. 102). Compared to the ferritin
model, the body iron model is reported to produce lower estimates of
prevalence of iron deficiency, better predict anemia, and be less
affected by inflammation, although this model has some limitations
(Ref. 103). Data from NHANES 1999-2002 for the general U.S. population
showed a prevalence of iron deficiency, based on serum ferritin
concentration (less than 15 nanograms (ng)/mL), body iron stores (based
on the ferritin model), and iron deficiency anemia (defined as having
iron deficiency and a low hemoglobin value) of 8.3, 6.5 and 1.9
percent, respectively (table 1). The IOM set age and gender specific
DRIs (EARs and RDAs) based on factorial modeling, which included basal
iron losses, menstrual losses, fetal requirements in pregnancy,
increased requirements during growth for the expansion of blood volume,
and/or increased tissue and storage iron (Ref. 100). Although the DRIs
were not based directly on a chronic disease risk, iron deficiency and
low iron stores over time will lead to iron deficiency anemia, an
advanced stage of iron deficiency (Ref. 100). Anemia is associated with
poor cognitive function, lower work performance, and low endurance in
the general population; delayed psychomotor development in infants; and
adverse pregnancy outcome (Ref. 100).
Relevant biomarker data were available from NHANES 2003-2006 for
certain subpopulations such as women of childbearing age (12 to 49
years old). Analyses of these data showed that about 14 percent of
women of childbearing age (12 to 49 years) had serum ferritin
concentration less than 15 ng/mL, while 10 and 14.5 percent of women
had inadequate stores of body iron based on the body iron model or
ferritin model, respectively (table 1). In addition, about 4.7 percent
of these women had iron deficiency anemia. Based on these prevalence
rates, the absolute numbers of individuals with iron deficiency in
women of

[[Page 11920]]

childbearing age using 2010 projected U.S. Census data translate into
7.2 or 11.6 million women of childbearing age (12 to 49 years of age)
with inadequate iron stores based on body iron model or ferritin model,
respectively. About 3.76 million of these women are considered to have
iron deficiency anemia. Thus, iron continues to be of public health
significance among women of childbearing age and pregnant women, who
account for 26 percent of the general U.S. population.
Iron is also identified as a nutrient of public health significance
in consensus reports. For example, Healthy People 2020 identified iron
as a nutrient of public health significance among young children (1 to
4 years of age), women of childbearing age (12 to 49 years of age), and
pregnant women, and announced an objective of a ten percent reduction
in iron deficiency (using the body iron model) by the year 2020 (Ref.
104). Similarly, the 2010 DGA identified iron as a nutrient of concern
among women capable of becoming pregnant and recommends choosing foods
that supply heme iron, which is more readily absorbed by the body,
additional iron sources, and enhancers of iron absorption such as
vitamin C-rich foods (Ref. 6).
Given the importance of the role of iron in public health and
continued significance of inadequate intakes and deficiency among women
of childbearing age, a significant portion of the general healthy
population, we tentatively conclude that iron is a nutrient of public
health significance and its declaration continues to be necessary to
assist consumers in maintaining healthy dietary practices. Therefore,
consistent with the factors used for mandatory declaration of non-
statutory nutrients (see section I.C.), we are not proposing any
changes to the current requirement for declaration of iron on the
Nutrition Facts label, as specified in Sec. 101.9(c)(8)(ii).
c. Vitamin A--Vitamin A must be declared as a percent DV on the
Nutrition Facts label (Sec. 101.9(c)(8)(ii)). In 1993, we required the
declaration of vitamin A in nutrition labeling because (1) it was found
in a limited number of foods within the food supply, and (2) a 1990 IOM
labeling report (Ref. 95) identified vitamin A as a nutrient of
potential public health significance and stated that certain
subpopulations (children under 5 years of age) were still at risk of
deficiency for this vitamin (58 FR 2079 at 2106). In response to the
2007 ANPRM, several comments recommended retaining the mandatory
declaration of vitamin A, with some noting that the 2005 DGA identified
it as a nutrient of concern (Ref. 36). Our analysis of intake data from
NHANES 2003-2006 estimated that about 45 percent of the general U.S.
population has usual vitamin A intakes from conventional foods below
the EAR, and 34 percent have intakes from conventional foods plus
dietary supplements below the EAR (table 1). However, the prevalence of
vitamin A deficiency is not apparent. Only about 0.3 percent of those
ages 6 years and older (excluding pregnant and lactating women) have a
serum retinol concentration (a biomarker of vitamin A status) below 20
mcg/dL, a cutoff level that is used as an indicator of vitamin A
deficiency (table 1) (Refs. 6 and 105). Because serum retinol levels
are tightly regulated (homeostatically controlled) and do not always
reflect total body status, using serum vitamin A for assessment of
vitamin A status of individuals may not be useful (Ref. 101). However,
the distribution of serum retinol levels in a population plus the
prevalence of individuals with serum retinol levels below a given
cutoff point may offer a better picture of the vitamin A status of a
population (Ref. 101). Based on the analysis of distribution of serum
retinol (NHANES 2003-2006), and the prevalence of those below the
cutoff of 20 mcg/dL (0.3 percent), we estimated that the prevalence of
vitamin A deficiency in the general U.S. population is not apparent.
The IOM recognized that vitamin A deficiency is rarely seen in the
healthy U.S. population (Ref. 105). Furthermore, the specific age and
gender DRIs (EAR and RDA) set by the IOM were based on the amount of
dietary vitamin A required to maintain adequate liver stores in well-
nourished subjects, rather than on a specific adverse public health
endpoint (Ref. 105). The DRIs represent an amount that will assure
vitamin A reserves to cover periods of increased needs such as stress
and low vitamin A intake (Ref. 105). In addition, the 2010 DGA does not
include vitamin A among the list of nutrients of public health concern
for the general U.S. population (Ref. 6).
We also considered whether any changes are necessary to the
provision for voluntary declaration of the portion of vitamin A
activity derived from [beta]-carotene, including whether its mandatory
declaration is appropriate, as suggested by a comment. One comment
noted that [beta]-carotene intake, in particular, needs to be
increased, but the comment provided no further explanation. The IOM did
not set DRIs for [beta]-carotene and other carotenoids due to limited
scientific data (Ref. 18). The only known function of provitamin A
carotenoids (i.e., [alpha]-carotene, [beta]-carotene, and [beta]-
cryptoxanthin, which can be converted into vitamin A (retinol) in the
body) in humans is to act as a source of vitamin A in the diet (Ref.
18). Furthermore, there is no clear evidence that suggests a protective
association between dietary vitamin A or [beta]-carotene and risk
reduction of chronic diseases, such as cardiovascular disease and
cancers (Ref. 105). In addition, evidence from large clinical trials
suggests that [beta]-carotene supplementation increases the incidence
of lung cancer in a high-risk population (e.g., current or former
smokers, asbestos workers) (Refs. 106 and 107). Further, the IOM
introduced mcg of RAEs (retinol activity equivalents) as a new unit for
expressing vitamin A activity to account for the reduced absorption for
provitamin A carotenoids, including [beta]-carotene (Ref. 105). This
new unit, which would be the appropriate unit for declaring vitamin A
on the Nutrition Facts label, takes into consideration vitamin A from
all sources as well as the bioavailability of [beta]-carotene and other
provitamin A carotenoids (see section II.J.3.).
Our analysis demonstrates that, even though vitamin A intakes
appear to be low, vitamin A deficiency based on an assessment of
vitamin A status is rare in the U.S. population. The IOM did not set a
quantitative intake recommendation for vitamin A based on a public
health endpoint. Thus, we tentatively conclude that vitamin A is no
longer a nutrient of public health significance for the general U.S.
population. Therefore, consistent with the factors for declaration of
non-statutory nutrients (see section I.C.), we are proposing to amend
101.9(c)(8)(ii) to no longer require, but to permit voluntary
declaration of vitamin A on the Nutrition Facts label. However, vitamin
A declaration would remain mandatory when vitamin A is added as a
nutrient supplement or claims are made about it on the label or in
labeling of foods. We are also not proposing to change the current
provision for voluntary declaration of the percent of vitamin A that is
present as [beta]-carotene, as specified in Sec. 101.9(c)(8)(vi). We
request comment about whether there is an appropriate alternative
analysis to application of the factors in section I.C. regarding the
mandatory declaration of vitamin A.
d. Vitamin C--Vitamin C must be declared as a percent DV on the
Nutrition Facts label (Sec. 101.9(c)(8)(ii)). In 1993, we required the
declaration of vitamin C because (1) a 1990 IOM labeling report (Ref.
95) identified vitamin C as a nutrient of potential

[[Page 11921]]

public health significance and stated that certain subpopulations were
considered at risk of deficiency (such as elderly individuals on
inadequate diets and infants fed cow's milk exclusively) (58 FR 2079 at
2106), and (2) vitamin C was thought to play a role in promoting the
intestinal absorption of non-heme iron, meaning that vitamin C in the
same food as iron was considered to help prevent iron deficiency
anemia, while excess vitamin C was considered to increase the risk of
excessive iron absorption (55 FR 29487 at 29501, July 19, 1990). In
response to the 2007 ANPRM about whether vitamin C is still a nutrient
of public health significance, several comments recommended retaining
the mandatory declaration of vitamin C, with some stating that vitamin
C should be retained because it is a nutrient of concern identified by
the 2005 DGA (Ref. 36), and is an enhancer of iron absorption for women
of childbearing age.
Our analysis of NHANES 2003-2006 estimated that about 35 percent of
the general U.S. population has usual vitamin C intakes below the EAR,
from conventional foods only and 27.5 percent have intakes below the
EAR from conventional foods and supplements (table 1). While the
prevalence of inadequate intake is high, prevalence of vitamin C
deficiency is not apparent in the U.S. population. Only about 6 percent
of the general population had serum vitamin C concentrations below 11.4
micromoles ([mu]mol)/L, a cutoff level that is used as an indicator of
vitamin C deficiency (Ref. 97 p.534; Ref. 101). The EAR for vitamin C
is based on estimates of body pool or tissue levels of vitamin C that
are required for antioxidant protection with minimal urinary loss, not
on a public health endpoint (Ref. 18).
The effects of vitamin C on risk of chronic diseases, such as
cardiovascular disease or cancer, are not conclusive at this time (Ref.
18). We issued a letter of enforcement discretion on qualified health
claims for vitamin C supplement intake and reduced risk of cancers, in
which we concluded that there was no credible evidence on the risk
reduction from vitamin C for most cancers (squamous cell cancer of the
esophagus, colorectal, laryngeal, lung, oral cavity, pancreatic,
pharyngeal, renal cell, and salivary gland cancers), and very limited
evidence for an association between vitamin C supplement intake and
gastric cancer (Ref. 108).
The 2010 DGA does not include vitamin C among the list of nutrients
of public health concern for the general U.S. population (Ref. 6).
However, the 2010 DGA recommends that women capable of becoming
pregnant choose foods that are enhancers of iron absorption, such as
vitamin C-rich foods (Ref. 6). While we agree that vitamin C enhances
iron absorption, the prevalence of vitamin C deficiency in this
subpopulation is not apparent. Only about 6 percent of this subgroup
had serum vitamin C concentrations below 11.4 [mu]mol/L (table 1).
Based on the previous analysis and information, we tentatively
conclude that while vitamin C intakes are low, vitamin C deficiency is
uncommon and vitamin C is no longer a nutrient of public health
significance for the general U.S. population. Therefore, consistent
with the factors we consider for declaration of non-statutory nutrients
(see section I.C.), we are proposing to amend Sec. 101.9(c)(8)(ii) to
no longer require, but to permit voluntary declaration of vitamin C on
the Nutrition Facts label. However, vitamin C declaration would remain
mandatory when vitamin C is added as a nutrient supplement or claims
are made about it on the label or in labeling of foods. We request
comment about whether there is an appropriate alternative analysis to
the application of the factors in section I.C. regarding the mandatory
declaration of vitamin C.
2. Essential Vitamins and Minerals That Are Voluntary
a. Vitamin D--The declaration of vitamin D content in nutrition
labeling is voluntary, unless vitamin D is added as a nutrient
supplement or claims are made about it (Sec. 101.9(c)(8)(ii)). In
1993, we determined that vitamin D is not of particular public health
significance in the United States because the human requirement for
vitamin D could be met with sufficient exposure to sunlight and milk
and other foods that were fortified with vitamin D. As a result,
deficiencies in this vitamin were very rare (58 FR 2079 at 2107). In
response to the 2007 ANPRM about what, if any, other micronutrients are
of public health significance, several comments recommended vitamin D
for mandatory declaration citing vitamin D inadequacy; relationship of
vitamin D to chronic disease risk (e.g., rheumatoid arthritis, multiple
sclerosis, and cancers, such as prostate, breast, lung, colon, and
colorectal cancers); and the 2005 DGA, which identified vitamin D as a
nutrient of concern for certain subpopulations (e.g., older adults,
people with dark skin, and those exposed to insufficient ultraviolet
band radiation) (Ref. 36).
The IOM set age and gender specific DRIs (EAR and RDA) for vitamin
D at a level that would achieve and maintain serum 25-hydroxy vitamin D
(25(OH)D) concentrations above a defined level (40 to 50 nanomoles
(nmol)/L) in order to maintain bone health (Ref. 22). Vitamin D has a
role in bone health through calcium absorption and uptake by bones
(Ref. 22). In addition, in 2008, we authorized a health claim for
calcium and vitamin D intake and reduced risk of osteoporosis (Sec.
101.72), signifying vitamin D's critical role in the risk reduction of
this chronic disease.
Vitamin D can be obtained through dietary sources, such as fish
(e.g., salmon, rockfish, and tuna) and shellfish, which are the primary
natural food sources of vitamin D. FDA affirmed certain uses of vitamin
D food ingredients as Generally Recognized as Safe (GRAS) with specific
limitations as listed in Sec. 184.1950. Under Sec. 184.1(b)(2), an
ingredient affirmed as GRAS with specific limitations may be used in
food only within such limitations, including the category of food,
functional use, and level of use. Any addition of the ingredient to
food beyond the limitations set out in Sec. 184.1950 requires either a
food additive regulation or an amendment of Sec. 184.1950. In this
way, FDA can ensure that the vitamin D ingredients are added to food at
safe levels. For detail on estimating dietary intake of substances in
food, see FDA's Guidance for Industry: Estimating Dietary Intake of
Substances in Food (Ref. 109). Under FDA regulations (Sec. Sec.
172.380 (21 CFR 172.380) and 184.1950), vitamin D can be added in
specific amounts to foods such as breakfast cereals, grain products and
pastas, fluid milks and milk products, and calcium-fortified juices. As
for any vitamin or mineral, when vitamin D is added to a food, the
total amount per serving must be declared in the Nutrition Facts label.
In addition to dietary sources of vitamin D from conventional foods and
dietary supplements, vitamin D is synthesized in the skin following
direct exposure to the sun. Therefore, sunlight exposure is an
important source of vitamin D.
Serum concentration of 25(OH)D is widely considered as a biomarker
of total vitamin D nutritional status and is recommended to be used for
assessing vitamin D total exposure from all sources, including
conventional foods, dietary supplements, synthesis from sun, and
conversion of vitamin D from adipose stores in liver (Ref. 22). Our
analysis of NHANES 2003-2006 data showed that about 18 percent of the
U.S. population 4 years and older (excluding pregnant and lactating
women) have serum 25(OH)D levels below the 40 nmol/L (a level set by
IOM as equivalent to EAR), which indicates an increased risk of
inadequate vitamin D exposure.

[[Page 11922]]

NHANES data collection normally does not include serum levels in the
northern regions of the United States in the winter months, when one
would expect a lower serum vitamin D level. Therefore, analysis of
NHANES data may underestimate the prevalence of low serum vitamin D
levels in the Unites States population. Analysis of NHANES 2005-2008
dietary data showed that, about 94 percent of the U.S. population have
usual vitamin D intakes below the EAR from conventional foods only and
62 percent have intakes below the EAR from conventional foods and
supplements (table 1). The IOM set the DRIs (e.g., EAR) assuming
minimal sun exposure (Ref. 22).
Furthermore, approximately 24 percent of the U.S. population ages 4
years and older have serum 25(OH)D concentrations between 30 and 50
nmol/L, levels that indicate risk for inadequacy according to the IOM
and CDC (Refs. 22 and 101). Approximately 32 percent of the U.S.
population have serum 25(OH)D levels below 50 nmol/L (a level set by
IOM as equivalent to RDA and associated with optimal benefit for nearly
all the population) (Ref. 22). Also, about 8 percent have serum 25(OH)D
levels below IOM's cutoff of 30 nmol/L and may be at increased risk of
vitamin D deficiency. Vitamin D deficiency results in inadequate bone
mineralization or demineralization of the skeleton including rickets,
osteomalacia, and osteoporosis (Ref. 22). The 2010 DGA, too,
highlighted vitamin D as a nutrient of concern for the U.S. population,
in general, rather than for specific population groups alone (Ref. 6).
We do not agree with some comments that suggested that vitamin D
intake should be mandatory on the label because of its relationship to
disease risk reduction, generally. The IOM did not set DRIs for vitamin
D based on its protective effect against diseases, such as cancers,
cardiovascular disease, and diabetes, because the scientific evidence
does not support a role other than that associated with bone health
(Ref. 22).
In view of the benefits of adequate vitamin D intakes on bone
health, reflected in the IOM's DRIs, data indicating inadequate
intakes, poor vitamin D status, and high prevalence of osteoporosis and
osteopenia (discussed previously in the calcium section, (Refs. 98 and
99) among the general U.S. population, we tentatively conclude that
vitamin D is a nutrient of ``public health significance,'' as described
in section I.C., and its mandatory declaration is necessary to assist
consumers in maintaining healthy dietary practices. Therefore,
consistent with the factors we consider for mandatory declaration of
non-statutory nutrients (see section I.C.), we are proposing to amend
Sec. 101.9(c)(8)(ii) to require the mandatory declaration of vitamin D
on the Nutrition Facts label. We request comment about whether there is
an appropriate alternative analysis to the application of the factors
in section I.C. regarding the mandatory declaration of vitamin D.
b. Potassium--The declaration of potassium content is voluntary,
except when a claim is made about it (Sec. 101.9(c)(5)). In 1993,
potassium did not meet our considerations for inclusion as a mandatory
element of nutrition labeling because no quantitative intake
recommendations were available in national consensus reports (58 FR
2079 at 2095). In response to our question in the 2007 ANPRM about
what, if any, other micronutrients are of public health significance,
several comments supported mandatory declaration of potassium on the
Nutrition Facts label because the 2005 DGA identified it as a nutrient
of concern (Ref. 36). One comment also pointed out that scientific
evidence from three meta-analyses of over 30 clinical trials shows that
high potassium intake is associated with reduced blood pressure in non-
hypertensive and hypertensive individuals (Refs. 110 to 112).
Our analysis of data from NHANES 2003-2006 shows that the usual
mean intakes of potassium from conventional foods only (2,644 mg/d) and
from conventional foods plus dietary supplements (2,651 mg/d) are below
the population-weighted AI of 4,622 mg/d. Where the mean usual intake
is at or above the AI, we consider that there is probably a low
prevalence of nutrient inadequacy in the population assessed. However,
where the mean usual intake is below the AI, the population's
prevalence of inadequacy cannot be estimated (Ref. 96). Therefore, the
likelihood of nutrient inadequacy cannot be estimated. Only about 1.9
percent of the general population has usual potassium intakes above the
AI from conventional foods only and 2.4 percent has intakes above the
AI from conventional foods plus dietary supplements (table 1),
indicating that the adequacy of intakes is very low. In the absence of
a sensitive biochemical indicator of potassium nutritional status, we
could not consider biomarker data to inform the determination of
prevalence of potassium deficiency. However, the IOM set age- and
gender-specific AIs for potassium based on risk of chronic disease. The
AI was set at a level that would maintain blood pressure, reduce the
adverse effects of sodium chloride intake on blood pressure, and reduce
the risk of recurrent kidney stones (Ref. 21). According to the CDC,
about one out of three U.S. adults has high blood pressure (Ref. 113).
In 2000, a FDAMA notification for a health claim about potassium,
blood pressure, and stroke was submitted to us under section
403(r)(2)(g) of the FD&C Act (Ref. 114). We did not object to the
notification and this meant that manufacturers could include the
following claim ``Diets containing foods that are good sources of
potassium and low in sodium may reduce the risk of high blood pressure
and stroke,'' on the label or labeling of any food that meets the
eligibility criteria described in the notification and meets the
general requirements for health claims (Sec. 101.14(e)(6)). Thus, we
recognize the importance of potassium in the risk reduction of these
chronic diseases. The 2010 DGA also concluded that potassium is a
nutrient of concern for the general U.S. population (Ref. 6).
In view of the benefits of adequate potassium intake in lowering
blood pressure, reflected in IOM's DRIs, and data indicating low
likelihood of potassium adequacy and high prevalence of hypertension
among the general population, we tentatively conclude that potassium is
a nutrient of public health significance for the general U.S.
population and its declaration is necessary to assist consumers in
maintaining healthy dietary practices. Therefore, consistent with the
factors we consider for mandatory declaration of non-statutory
nutrients (see section I.C.), we are proposing to amend Sec.
101.9(c)(8)(ii) to require the mandatory declaration of potassium.
3. Other Essential Vitamins and Minerals
Several other essential vitamins and minerals, in addition to
vitamin D and potassium, may be declared on the Nutrition Facts label,
i.e., vitamin E, vitamin K, vitamin B6, vitamin
B12, thiamin, riboflavin, niacin, folate, biotin,
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, and chloride. In response to
the 2007 ANPRM about what, if any, other micronutrients are of public
health significance, several comments recommended mandatory declaration
of these voluntarily declared essential vitamins and minerals: Vitamin
E, folate, vitamin B12, magnesium, and phosphorus. The
reasons cited in

[[Page 11923]]

comments included: (1) The 2005 DGA identification of these nutrients
as nutrients of concern (Ref. 36); (2) the need to provide information
to patients; (3) the need to heighten consumer awareness; and (4) the
intakes of these nutrients are inadequate in the U.S. population or
subpopulations (Ref. 47).
Based on FDA's analysis of available data using the factors we
consider for mandatory and voluntary declaration of non-statutory
nutrients (see section I.C.) and comments received on essential
vitamins and minerals that are currently voluntarily declared, we are
not proposing any changes to the current provisions for voluntary
declaration (for detailed information and the analysis of each of the
vitamins and minerals see Ref. 115). We reviewed data related to the
intake and status of nutrients where available standards allow for such
calculations (table 1). Consistent with the factors (see section I.C.),
essential vitamins and minerals (with the exception of potassium and
vitamin D discussed previously) that are voluntarily declared should
continue to be permitted to be voluntarily declared (Ref. 115).
Therefore, we are not proposing any changes to the provisions for
voluntary declaration of vitamin E, vitamin K, vitamin B6,
vitamin B12, thiamin, riboflavin, niacin, folate, biotin,
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, and chloride.
In addition, several comments recommended mandatory declaration of
choline, which is currently not permitted to be declared on the
Nutrition Facts label. Based on the factors we consider (see section
1.C.) and comments that asked us to provide for its declaration on the
Nutrition Facts label (Ref. 115), we tentatively conclude that the
voluntary declaration of choline is consistent with the factors we
consider for voluntary declaration (table 1) and, therefore, we are
proposing to permit the voluntary declaration of choline on the
Nutrition Facts label.
4. Summary
In summary, based on an analysis of the factors FDA considered (as
described in section I.C.), comments received, and other data and
information set forth previously, FDA tentatively concludes that
calcium, iron, vitamin D and potassium are nutrients of public health
significance and their declarations on the Nutrition Facts label are
necessary to assist consumers in maintaining healthy dietary practices.
Calcium is considered a nutrient of public health significance due to
the benefits of adequate calcium intake on bone health, and the
relatively low intakes of calcium and the high prevalence of
osteoporosis and osteopenia among the U.S. population. Iron is
considered a nutrient of public health significance due to the
continued inadequate intakes and deficiency (using relevant biomarker
data) among women of childbearing age, who comprise a significant
portion of the general healthy U.S. population. Although the DRIs for
iron were not based on a chronic disease risk, iron deficiency and low
iron stores over time will lead to iron deficiency anemia, an advanced
stage of iron deficiency. Anemia is associated with poor cognitive
function, lower work performance, and low endurance in the general
population; delayed psychomotor development in infants; and adverse
pregnancy outcome. Vitamin D is considered a nutrient of public health
significance due to the benefits of adequate vitamin D intake on bone
health, data indicating inadequate intakes and status (both from total
exposure (serum data) and dietary intake data), and the high prevalence
of osteoporosis and osteopenia among the U.S. population. Adequate
intake of vitamin D is essential for promoting calcium absorption in
the gut and for maintaining adequate calcium levels in the blood and
thus promoting bone health. Potassium is considered a nutrient of
public health significance due to the benefit of adequate intake of
potassium in lowering blood pressure, reducing the adverse effects of
sodium chloride intake on blood pressure and reducing the risk of
recurrent kidney stones, and due to data indicating a low likelihood of
potassium adequacy and a high prevalence of hypertension among the
general U.S. population.
Although we continue to consider, consistent with our rationale put
forth in 1993, that a vitamin or mineral's public health significance
should be the key factor in mandatory labeling (58 FR 2079 at 2106),
the proposed vitamins and minerals of public health significance (i.e.,
potassium, calcium, vitamin D, and iron) and dietary fiber (listed on
the label as a nutrient to increase) do represent various food groups.
For example, potassium is found in most food groups, especially
vegetables, fruits, and milk and milk products. Milk and milk products
contribute substantially to calcium intake. Sources of heme iron
include lean meat, poultry and seafood, while the non-heme sources of
iron come from plants foods, such as beans, lentils and spinach.
Although vitamin D is mostly found in fortified foods in the United
States, such as fluid milk and some milk products (e.g., yogurt), its
natural sources include seafood. Dietary fiber is generally found in
most fruits and vegetables, whole grains and beans.
The 2010 DGA recommends increasing the amount and variety of
seafood in place of some meat and poultry (Ref. 6). As mentioned, fish/
seafood is the primary source of naturally occurring vitamin D (Ref.
6). Data shows that fish/seafood only provides 9 percent of the total
vitamin D intake in the United States (Ref. 116). Therefore, we
tentatively conclude that the proposed mandatory declaration of vitamin
D on the label would allow consumers to understand the relative
significance of the contribution of vitamin D from natural food
sources, in addition to fortified foods, in the context of the total
daily diet and also is necessary to assist consumers in maintaining
healthy dietary practices.
We are not aware of any unintended consequences of mandatory
listing, in general, of vitamins and minerals. We invite comment,
including the submission of data and information on whether the
mandatory listing of vitamins and minerals somehow impacts food
fortification practices. We invite comment on the proposed mandatory
declaration of vitamin D, potassium, calcium and iron on the label,
including how we consider the public health significance of each. We
also invite comment on whether the presence of these nutrients presents
concerns related to label space or the need for consumer education.

[[Page 11924]]

Table 1--Prevalence of Adequacy and Inadequacy (From Conventional Foods and Water) and Total Intake (Conventional Foods, Water, and Supplement) and
Status Biomarkers for Essential Vitamins and Minerals Among the U.S. Population, Ages 4 Years and Older
[Excluding pregnant and lactating women] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Usual nutrient intake \2\ Status biomarkers
--------------------------------------------------------------------------------------------------------
% Below weighted EAR \4\ % above weighted AI \5\ (mean
Nutrients Weighted EAR/AI ------------------------------------ intake)
\3\ ----------------------------------- Biomarker % Below cutoff
Food Food plus Food plus cutoff
supplement Food supplement
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamins
--------------------------------------------------------------------------------------------------------------------------------------------------------
Choline (NHANES 2005-2008)... 460 mg (AI)..... ................ ................ 10 (mean = 311 10 (mean = 312 NA............. NA
mg). mg).
Folate....................... 304 mcg DFE..... 8.7............. 7.3............. ................ ............... Serum folate < 0
2 ng/mL.
RBC folate < 95 0.26
ng/mL
Women 12-49 yrs
Serum folate < 0
2 ng/mL
RBC folate < 95 0.36
ng/mL
Niacin 6 7................... 11 mg NE........ 2.1............. 1.7............. ................ ............... NA............. NA
Riboflavin 6 7............... 0.9 mg.......... 1.5............. 1.3............. ................ ............... NA............. NA
Thiamin 6 7.................. 0.9 mg.......... 5.6............. 3.8............. ................ ............... NA............. NA
Vitamin A.................... 531 mcg RAE..... 45.............. 34.............. ................ ............... Serum A < 20 0.3 \8\
mcg/dL.
Vitamin B6 6 7............... 1.1 mg.......... 9.4............. 7.3............. ................ ............... NHANES 2005- 10
2006 < 20 nmol/
L.
Vitamin B12.................. 1.9 mcg......... 2.3............. 2.2............. ................ ............... Serum B12 < 200 2.0
picograms (pg)/
mL.
19-50 yrs...... 0.7-2.5
2 mcg (51 yrs Women 51 yrs and 51 yrs and 3.3-5.2
and older). older. older.
6.4-7.5
Men 51 yrs and
older
0.6-0.7.........
Vitamin C.................... 61 mg........... 35.............. 27.5............ ................ ............... Serum C < 11.4 6.1 \8\
[micro]mol/L.
Women 12-49 yrs. Women 12-49 yrs. ................ ............... Women 12-49 yrs 6.00
41.............. 30..............
Vitamin D.................... 10 mcg.......... 93.7 (NHANES 62 (NAHNES 2005- ................ ............... Serum 25 (OH)D: 17.6
2005-2008). 2008). <40 nmol/L.
30-50 nmol/L... 24
< 30 nmol/L.... 8.3
Vitamin E.................... 11 mg [alpha]- 92.............. 64.............. ................ ............... Serum E < 11.6 0.9 \8\
tocopherol. [micro]mol/L.
Vitamin K 6 7................ 95 mcg (AI)..... ................ ................ 27.2 (mean = 30.9 (mean = 88 NA............. NA
82.9 mcg). mcg).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Minerals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Calcium...................... 885 mg.......... 49.............. 37.............. ................ ............... NA............. NA
Copper 6 7................... 0.7 mg.......... 5.2............. 4.9............. ................ ............... NA............. NA
Iron (probability approach See footnote 3.. 3.5............. 3.3............. ................ ............... NHANES 1999-
method) \9\. 2002 \10\.
Serum ferritin 8.3
< 15 mcg/L.
Ferritin model. 6.5
Anemia......... 1.9
Women, 12-49
yrs
NHANES 2003-
2006:.
Women 12-49 yrs. Women 12-49 yrs. Serum Ferritin 14
11.2............ 10.4............ < 15 mcg/L 10
Body Iron model 14.5
Ferritin Model 4.7
Anemia.
Iodine 6 7................... 91 mcg.......... 2.3 \11\........ 2.3............. ................ ............... Urinary iodine
NHANES 2007-
2008:.

[[Page 11925]]

<50 ng/mL \12\. 8.7 \8\.
<100 ng/mL \13\ Median =
165 ng/mL.
Magnesium.................... 283 mg.......... 56.............. 53.............. ................ ............... NA............. NA.
Phosphorus................... 640 mg.......... 3............... 2.6............. ................ ............... NA............. NA.
Potassium.................... 4,622 mg (AI)... ................ ................ 1.9 (mean = 2.4 (mean = NA............. NA.
2,644 mg). 2,654 mg).
Selenium 6 7................. 43 mcg.......... 1.4............. 1.1............. ................ ............... NA............. NA.
Zinc 6 7..................... 7.7 mg.......... 13.4............ 9.1............. ................ ............... NA............. NA.
--------------------------------------------------------------------------------------------------------------------------------------------------------
NA = Data is not available in NHANES; mg = milligrams; mcg = micrograms; DFE = Dietary folate equivalents; NE = Niacin equivalents; RAE = Retinol
activity equivalents.
\1\ All prevalence of nutrient adequacy or inadequacy and status biomarker data is based on NHANES 2003-2006 unless otherwise is reported. All data
analysis are based on ages 4 years and older (excluding pregnant and lactating women), unless reported otherwise.
\2\ Usual nutrient intake distributions from conventional foods or conventional foods plus supplements are determined using the National Cancer
Institute statistical method for all nutrients except iron (see footnote 9 to this table and Ref. 48).
\3\ Weighted Estimated Average Requirement (EAR) and Adequate Intake (AI) for all nutrients (except iron) are based on the U.S. population ages 4 years
and older using U.S. Census Bureau, Population Projection for 2005, Middle Series Data (NP-D1-A) (Ref. 48,117). For iron, the published IOM tables
(tables I-6 and I-7) of probability of iron requirement distribution were used (Ref. 100).
\4\ EAR cut-point method used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy.
\5\ For nutrients with an AI, prevalence of nutrient adequacy was determined when mean usual nutrient intakes are at or above the AI or based on the
percent of those above the AI.
\6\ The Agency did not receive any comments for these nutrients (which voluntary declaration is permitted) in response to the 2007 ANPRM. In addition,
dietary intake or status biomarker data were not provided in the NHANES database for chromium, biotin, pantothenic acid, molybdenum, manganese and
chloride and, therefore, these nutrients are not listed in this table.
\7\ The DRIs for these nutrients were not based on a public health endpoint (e.g., chronic disease).
\8\ Ages 6 years and older.
\9\ Probability approach method was used to determine the prevalence of nutrient inadequacy for iron. The PC-SIDE software developed by the Iowa State
University was used to determine the usual intake distribution for iron.
\10\ Iron deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables (transferrin saturation, serum
ferritin, and erythrocyte protoporphyrin). Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to
ferritin. Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. NHANES 1999-2002 did not measure transferrin
receptor, therefore body iron model could not be analyzed for the general population (ages 4 years and older). NHANES 2003-2006 did not measure all
iron biomarkers for all ages (4 years and older), thus serum ferritin, body iron model or ferritin model could not be analyzed for all ages during
this time period.
\11\ Iodine nutrient intake data are calculated from the Total Diet Study 2003-2008 and intake data are calculated from NHANES 2003-2008 (https://www.nutrientdataconf.org/PastConf/NDBC36/7-3_Juan_NNDC2012.pdf).
\12\ One criterion for iodine adequacy is that not more than 20 percent be below the urinary iodine cutoff of 50 ng/mL (indicator of moderate
deficiency) (Ref. 118).
\13\ WHO categories for median urinary iodine concentrations are widely used to define iodine intake (Ref. 118). Median intake levels below 100 ng/mL
may indicate mild iodine deficiency.

I. Reference Daily Intakes for Vitamins and Minerals

1. Need To Update RDIs
RDIs used to calculate the percent DVs for vitamins and minerals
that are required or permitted to be declared on the Nutrition Facts
label are codified in Sec. 101.9(c)(8)(iv). We established the RDIs in
1993 and in 1995, and explained our rationale and relevant
considerations during those rulemakings (58 FR 2079; 60 FR 67164; see
also Ref. 1). We noted specifically that the purpose of establishing
RDIs for vitamins and minerals was to provide ``label reference
values'' intended to help consumers to understand nutrient levels in
the context of the total daily diet, to compare foods, and to plan
general diets (58 FR 2206 at 2213). We recognized that nutritional
needs vary considerably among consumers, but noted that no other viable
option existed other than a single reference value (58 FR 2206 at
2213). Thus, RDIs are intended as general food labeling reference
values and are not intended to represent dietary allowances for
individuals (55 FR 29476 at 29478). While RDIs are not precise values
for certain age and sex groups, they function as an overall population
reference to help consumers judge a food's usefulness in meeting
overall daily nutrient requirements or recommended consumption levels
and to compare nutrient contributions of different foods (55 FR 29476).
IOM reports published since 1997 provide new information for our
use in reconsidering the RDIs. The DRIs revised many of the previously
set RDAs for vitamins and minerals. Four types of DRIs are relevant to
the discussion on RDIs for vitamins and minerals: EAR, RDA, AI, and UL.
We describe each of these DRIs in section I.B.2. According to the new
DRI reports, some nutrients that had RDAs now have an AI because it was
determined that data were not sufficient to set a new RDA (e.g.,
vitamin K), whereas others that had ESADDIs now have either an RDA
(copper and molybdenum) or an AI (manganese, fluoride, and chromium).
The IOM Labeling Report (Ref. 25) recommended that FDA use a
population-weighted EAR or, in its absence, a population-weighted AI as
the basis for establishing DVs for vitamins and minerals. In developing
these recommendations, the IOM

[[Page 11926]]

indicated that the reference values on food labeling are to enable
consumers to compare the nutrient content of different food products
and to determine the relative contributions of a food to an overall
health promoting diet. The IOM Labeling Committee did not consider that
the information in nutrition labeling is used to plan individual diets.
The IOM recommended that the DVs should be based on a population-
weighted value of the EAR for the different life stage and gender
groups so that the DVs are representative of the various population
groups in proportion to their contribution to the overall population. A
DV defined this way would represent a central value of the requirements
of the population, with individual requirements varying around this
value. The IOM Labeling Committee further stated that the EAR
represents the most accurate representation of the true contribution of
food to total nutrient needs of the general population, whereas the RDA
provides an exaggerated impression of Americans' daily needs and, thus,
would systematically under-represent the true contribution of an
individual food to many consumers' needs. The IOM Labeling Committee
concluded that the EAR is the best estimate of any given individual's
requirements, because the EAR is the median of the estimated
distribution of requirements for a particular life stage and gender
group. Therefore, the IOM Labeling Committee stated that setting the DV
at the EAR is most likely to help individuals understand nutrition
information about vitamins and minerals on the Nutrition Facts label in
the context of their total daily diet. The IOM Labeling Committee
further recommended that, in the absence of an available EAR, a
population-weighted AI should be used as the basis for a DV.
The IOM Dietary Planning Report noted that intake goals (i.e.,
RDAs) should be translated into dietary plans to help individuals
choose foods that will make up a healthful diet. The IOM Dietary
Planning Report gave several examples of dietary plans such as the
Nutrition Facts label, United States Food Guide Pyramid and the Dietary
Guidelines for Americans that are intended to help consumers choose
foods that are part of a healthful diet (Ref. 26). This report noted
that when food guides such as those mentioned previously are used,
reference standards for nutrients, such as RDAs, are implicitly used in
planning individual diets (Ref. 26). The recommendations in the IOM
Labeling Report and the IOM Dietary Planning Report have been the
subject of much debate in the scientific community, and several review
articles about the basis for selecting the DRI values that are most
appropriate for setting DVs (i.e., RDIs) have been published in
scientific journals (Refs. 119 to 126).
The 2007 ANPRM asked for public comment on whether the DV should be
based on an EAR or RDA; how AIs should be used for determining DVs for
vitamins and minerals without an EAR or RDA; and whether DVs should be
based on a population-coverage or population-weighted approach. We
received several comments both on the overall approach for setting the
RDIs and on the DRIs for specific vitamins and minerals (Ref. 47).
We tentatively conclude that the existing RDIs for vitamins and
minerals should be revised based on the DRIs set by the IOM that
reflect the most current science regarding nutrient requirements. Our
consideration of the DRIs, relevant recommendations, and comments
received in updating the RDIs is presented in this document.
2. Approach to Setting RDIs: EAR Versus RDA
The percent DV advises the consumer how much of the recommended
intake of that nutrient is provided by the food (58 FR 2206 at 2213).
The DV for the nutrient, on which the percent DV declaration is based,
is not to be interpreted as a precise recommended intake level for an
individual; it is for use as a general guide or reference value that
can help the consumer judge a food's usefulness in meeting overall
daily nutrient requirements or recommended consumption levels and to
compare nutrient contributions of different foods (55 FR 29476). We
established the RDIs for vitamins and minerals based primarily on RDAs,
and using other available recommendations for those vitamins and
minerals for which an RDA was not established (55 FR 29476; 58 FR 2206;
60 FR 67164). Overall, comments to the 2007 ANPRM supported continuing
to use the RDA as the basis for the DVs for vitamins and minerals,
whereas some other comments supported using the EAR instead (Ref. 47).
Considering the purpose of the DV, and for the reasons explained in
this document, we tentatively conclude that RDAs, when available,
continue to provide the most appropriate basis for establishing RDIs.
RDAs are available for calcium, copper, folate, iodine, iron,
magnesium, molybdenum, niacin, phosphorus, riboflavin, selenium,
thiamin, vitamins A B6, B12, C, D, and E, and
zinc (Refs. 16 to 19,22).
The EAR, by definition, is the median requirement that is most
likely to be close to an individual's actual needs within a particular
life stage and gender group, with the needs of half of the individuals
within that group falling above or below the EAR. The EAR is a
quantitative intake recommendation that is used to derive target
nutrient intake goals for the planning of diets for groups, but is not
used as a target intake goal for individuals. Examples of planning for
groups include planning diets in an assisted living facility for senior
citizens or planning menus for a school nutrition program (Ref. 26).
However, the EAR is not intended to be a target intake level for
individuals because an individual does not know how their needs relate
to the EAR. While the RDA may not be the best estimate of any given
individual's nutrient requirement, which is usually unknown, the RDA
was developed as a target intake level for individuals and is designed
to meet the nutrient needs of practically all (97 to 98 percent)
individuals within a life stage and gender group. Therefore, if the RDI
were to be based on the EAR, the RDI would not meet the daily nutrient
requirements for some consumers and understate target intake levels. In
contrast, an RDI that is based on a RDA would meet the daily nutrient
requirements for the majority of all individuals 4 years of age and
older. As we explained during the NLEA rulemaking, while RDIs are not
precise values for specific age and sex groups, they function as an
overall population reference to help consumers judge a food's
usefulness in meeting overall daily nutrient requirements or
recommended consumption levels and to compare nutrient contributions of
different foods (55 FR 29476). An RDI based on the RDA would mean that
a product with 100 percent of the DV would have a higher probability of
meeting an individual's nutrient needs than if the RDI was based on the
EAR.
In addition, consumers have indicated that they use the label,
among other things, to make dietary judgments about a food and to plan
meals. Our 2008 Diet and Health Survey reported that, among consumers
who use the label when they buy a product for the first time, 62
percent often or sometimes use the label to help in meal planning; 85
percent often or sometimes use the label to get a general idea of the
nutritional content of the food; and 90 percent often or sometimes use
the label to see how high or low the food is in things like calories,
salt, vitamins, or fat (Ref. 41). A series of surveys conducted by the

[[Page 11927]]

International Food Information Council over the past several years also
showed that approximately 65 percent of respondents used the Nutrition
Facts label to decide whether to purchase or consume a food, and
different individuals focus on different aspects of the label (e.g.,
calories, fat, or sodium) (Refs. 127 to 130).
We recognize that the recommendations of the 2003 IOM Labeling
Report (Ref. 25) differ from the conclusions of the 2003 IOM Planning
Report (Ref. 26). The IOM Labeling Report recommends using the EAR as
the basis for developing DVs, whereas the IOM Planning Report indicated
that the RDAs are appropriate targets for nutrient intakes for
individuals. Inadequate intakes of some nutrients continue to be of
public health significance, as noted by the 2010 DGA, which identified
potassium, calcium, and vitamin D as nutrients of public health concern
for general U.S. population and iron, folic acid, and vitamin
B12 for certain segments of the population (Ref. 6). Based
on these concerns of inadequate nutrient intakes, we find that the IOM
Dietary Planning Report discussion supports the use of RDAs as the
basis for establishing reference values for the purposes of food
labeling. We continue to believe that given the greater coverage
provided by the RDAs compared to the EARs, more individuals who use the
percent DV information to select foods, compare foods, or plan diets
will have greater assurance that their nutrient needs are being met (58
FR 2206 at 2213). RDAs and AIs, not EARs, are also cited in both the
2010 DGA and the USDA's Food Patterns, which were formerly known as the
MyPyramid Food Patterns (Refs. 6 and 131). It is important to
reiterate, however, that the RDIs are not the same as RDAs. The RDAs
are recommended intake levels set for different age and gender groups,
whereas the RDIs are intended to provide an overall population
reference value for use in calculating the percent DV for the food
label that can help consumers understand the nutritional content of
foods in the context of the total daily diet (55 FR 29476 at 29481 and
58 FR 2206 at 2213).
Finally, we considered the potential for the RDIs to influence the
vitamin or mineral content of foods, as suggested by several comments
(Ref. 47). We are not persuaded that using an EAR will promote rational
fortification and that using the RDA as the basis for the RDI will lead
to overconsumption of vitamins and minerals, as was suggested by a
comment (Ref. 47). FDA's principles of rational fortification are
expressed in our fortification policy (Sec. 104.20). The addition of
nutrients to foods is also governed by the requirements established in
food standards of identity (21 CFR parts 130 to 169), nutrition quality
guidelines (21 CFR part 104), substitute food regulations (Sec.
101.3(e)), and relevant specifications in food additive and food
substance regulations (for example, folic acid (Sec. 172.345) and
vitamin D (Sec. Sec. 184.1950 and 172.380)). Consistent with our
previous position (58 FR 2206 at 2210), we acknowledge that some
manufacturers may fortify products to a specific percentage of the DV
(e.g., 25 percent) and, to the extent this practice continues, nutrient
levels in these foods would be affected by updated RDI values. Changing
the basis from the current RDA approach to EARs would lower RDIs for
many important nutrients. Regardless of whether the basis for the RDI
is the RDA or EAR, manufacturers must comply with relevant regulations,
and we urge them to follow the principles stated in our fortification
policy. With respect to the concern for risk of excessive intakes of
vitamins and minerals, we conducted a thorough analysis of available
data to determine whether intakes of vitamins and minerals from both
foods and dietary supplements exceed established ULs. An analysis of
NHANES (2003-2006) data showed that usual total nutrient intakes (from
both conventional foods and dietary supplements) at the 90th percentile
do not exceed the ULs for most vitamins and minerals at any age group,
except for zinc intake, vitamin A (preformed), iodine intake and folic
acid intake among children 4 to 8 years (Ref. 132).
While there were a few exceptions, we have determined that such
intakes are not of public health significance, and for some nutrients,
are not a result of discretionary fortification. Therefore, we do not
consider that the existing approach of using RDAs as the basis for RDIs
leads to widespread overconsumption of vitamins and minerals. Moreover,
about half of the proposed RDIs decrease when compared to the current
RDIs (table 2) because many of the new RDAs and AIs established by the
IOM are now lower than previously set RDAs or ESADDIs. Most of the RDIs
proposed in this rulemaking that would increase (i.e., calcium, vitamin
D, dietary fiber, and potassium) have also been proposed by FDA to be
nutrients of public health significance for the general U.S. population
(see section II.H.). Furthermore, none of the RDIs proposed in this
rulemaking exceed the ULs for children 4 to 8 years of age (see tables
11a and 11b of the 2007 ANPRM).
Therefore, we tentatively conclude that RDAs, when available,
provide the most appropriate basis for establishing RDIs. Using
corresponding RDAs, proposed Sec. 101.9(c)(8)(iv) would update the
RDIs for calcium, copper, folate, iodine, iron, magnesium, molybdenum,
niacin, phosphorus, riboflavin, selenium, thiamin, vitamins A,
B6, B12, C, D, and E, and zinc, as shown in table
2. We request comment on our analysis and request data and factual
information, including any additional data on what role, if any, the
basis of the DV (EAR or RDA) has in consumption of nutrients above the
UL and in discretionary fortification of foods.
3. Approach to Setting RDIs: Adequate Intake
We consider that, in the absence of RDAs, AIs represent the best
estimate of adequate daily nutrient intake level based on available
science and, as such, they provide an appropriate basis for selecting
RDIs for those vitamins and minerals where available data are
insufficient to determine RDAs. While the prevalence of inadequacy of a
nutrient with an AI cannot be determined, AIs, like RDAs, are goals for
nutrient intakes and AIs are expected to meet the nutrient needs of
most healthy people. The IOM noted that usual individual intakes for a
nutrient that are equal to or above the AI can be assumed adequate
(Ref. 25). We acknowledge that there is more uncertainty with an AI
than an EAR or RDA. However, in the case of nutrients without
established RDAs, AIs reflect the most current scientific
recommendations for intake (Ref. 25).
Moreover, using the AIs (where RDAs are not available) would ensure
consistency in the basis of setting RDIs. We agree with comments to the
ANPRM that RDIs for vitamins and minerals and consequently, percent DVs
declared on the label, should have comparable meanings in order to
enable consistent use. RDIs should not be based on average requirements
(i.e., EAR) for some nutrients, but goals for intakes (i.e., RDAs) for
others. AIs, in the absence of RDAs, would provide uniformity in
setting RDIs for vitamins and minerals based on goals for their
intakes. Most of the comments in response to the 2007 ANPRM supported
the AI as the basis for the DV for those nutrients for which no EARs or
RDAs have been established (i.e., biotin, chloride, choline, chromium,
manganese, pantothenic acid, potassium, and vitamin K) (Ref. 47).

[[Page 11928]]

Therefore, we tentatively conclude that AIs provide an appropriate
basis for selecting RDIs for those vitamins and minerals where
available data are insufficient to determine RDAs. Accordingly, we are
proposing to use AIs to set the RDIs for biotin, chloride, choline,
chromium, manganese, pantothenic acid, potassium, and vitamin K.
4. Approach to Setting RDIs: Tolerable Upper Intake Level
The UL is the highest average daily intake level likely to pose no
risk of adverse health effects for nearly all people in a particular
group. As intake increases above the UL, potential risk of adverse
effects may increase (Ref. 96). The UL can be used to estimate the
percentage of the population at potential risk of adverse effects from
excess nutrient intake (Ref. 25). However, the UL is not intended to be
a recommended level of intake for vitamins and minerals where excess
intake is not a concern, as there is generally (with the exception of
folate in the prevention of neural tube defects) no established benefit
for consuming amounts of nutrients above the RDA or AI (Ref. 96).
Therefore, we do not consider the UL to be an appropriate basis for
setting RDIs. However, as the IOM noted, ULs can be used to plan diets
to ensure usual intakes of vitamins and minerals are below the UL for
individuals or to plan diets for groups to minimize the proportion of
the population at risk of excess nutrient intake (Ref. 25).
Therefore, we tentatively conclude that the UL does not provide an
appropriate basis for establishing RDIs for vitamins and minerals. As
noted previously (sections II.I.2. and II.I.3.), we tentatively
conclude that the RDAs and, for nutrients where an RDA has not been
established, AIs are the most appropriate quantitative intake
recommendations for setting RDIs that can help consumers to plan
general diets and understand the nutritional content of the foods they
buy in the context of the total daily diet.
5. Approach to Setting RDIs: Population-Weighted Versus Population-
Coverage
As discussed in the 2007 ANPRM, we set the RDIs based on a
population-coverage approach, after concluding that this approach was
more appropriate than a population-weighted approach, in part, so that
vulnerable or at-risk groups would be sufficiently covered by the DV
(72 FR 62149 at 62150). In determining an approach for setting RDIs in
this proposed rule, we considered recommendations of current consensus
reports, scientific review articles, and comments to the 2007 ANPRM. We
presented a comparison of potential RDIs based on the various
established DRIs and applying the population-coverage versus
population-weighted approaches (see tables 11A and 11B of the 2007
ANPRM). As discussed in this document, we tentatively conclude that
RDIs for vitamins and minerals should continue to be based on a
population-coverage approach, using the highest RDA and, where an RDA
has not been established, the highest AI.
We continue to agree with the rationale we set forth in 1993 that
the population-coverage approach would sufficiently cover the
vulnerable or at-risk groups (58 FR 2206 at 2211). Using the highest
age and gender group RDA/AI value (i.e., a population-coverage
approach) would avoid a higher risk of nutrient inadequacy among
certain segments of the population because such a value is not derived
from averaging the requirements for populations with lower needs
(children and elderly) and those with greater needs (adolescents or
adults). While incidences of deficiency diseases, such as pellagra, are
now rare, intakes and status biomarkers of certain nutrients continue
to be inadequate and of public health significance (see section II.H.).
Although, for some nutrients, the population-coverage RDA approach
would result in RDIs that are higher than the nutrient requirements for
some consumers, RDA, by definition, is the target intake goal for
nutrient intakes for individuals. In addition, as noted by one comment,
unlike the population-weighted approach, the population-coverage
approach would not be susceptible to changes in age demographics of the
population. Therefore, any future revisions to RDIs would be based
primarily on new scientific data related to nutrition or new dietary
recommendations, and we would not need to revise RDIs solely based on
the availability of new census data.
We also considered concerns that the population-coverage approach
may lead to excessive intakes of nutrients. As in the case of the RDA
approach (discussed previously), we find such concerns unfounded.
Intakes of vitamins and minerals generally do not exceed the ULs under
current RDIs that are based on a population-coverage RDA approach. In a
few instances where total usual intakes of vitamins and minerals by
children 4 to 8 years exceed corresponding ULs, we have determined that
such intakes are not of public health significance, and for some
nutrients, are not as a result of fortification (see accompanying Ref.
115). Furthermore, because many of the new RDAs and AIs established by
the IOM are now lower than previously set RDAs or ESADDIs, the RDIs
based on a population-coverage RDA for many nutrients will decrease
(see table 2). We consider that, from a public health perspective, it
is more important for the DV of vitamins and minerals to cover the
intake needs of most consumers than it is for certain age and gender
groups to be covered by the DV based on their proportion of the overall
population. We are also not aware of any data indicating that use of a
population-coverage approach versus a population-weighted approach
results in increases in nutrient consumption. Therefore, we tentatively
conclude that the population-coverage approach using the highest RDA
or, in its absence, the highest AI continues to provide an appropriate
basis for setting RDIs for vitamins and minerals. We are proposing to
amend Sec. 101.9(c)(8)(iv) to update RDIs as presented in table 2.
6. Declaration of Absolute Amounts of Vitamins and Minerals
Currently, mandatory nutrients and, when declared, voluntary
nutrients must be declared by their absolute amounts in weight on the
Nutrition Facts label, except for vitamins and minerals (other than
sodium and potassium) (see Sec. 101.9(d)(7)(i)). Thus, except when the
linear label format is used (Sec. 101.9(j)(13)(ii)(A)(2)), listings
for sodium and potassium (when declared) appear above the third bar and
include both weight amounts and percent DVs, while vitamins A and C,
calcium, and iron appear below the third bar and include percent DVs
only. In the case of dietary supplements, both the quantitative amount
by weight and percent DV (if available) are required to be declared on
the Supplement Facts label (Sec. 101.36(b)(2)(ii) and (iii)). The 2007
ANPRM invited comment on whether the absolute amounts (e.g., grams or
milligrams) of mandatory and voluntary vitamins and minerals should be
included on the Nutrition Facts and Supplement Facts labels (72 FR
62149 at 62170). Most comments supported including the absolute amounts
of these nutrients in addition to the requirement of listing percent
DVs.
Research suggests that consumers, in general, and physicians who
prescribe nutrient supplements for specific medical reasons have
difficulty understanding how percent DVs relate to the absolute amounts
of nutrients listed on the Nutrition Facts label (Ref.

[[Page 11929]]

133). More recently, in a report on labeling and fortification, the IOM
recommended listing both absolute amounts (e.g., mg/serving) and
percent DVs to assist consumers who have difficulty understanding how
to interpret the percent DV declaration (Ref. 25). This IOM report also
stated that absolute amounts declaration for all micronutrients would
maintain consistency in how nutrients are declared on the Nutrition
Facts label.
Based on the IOM's recommendation, research findings, and comments
received, we are proposing to require that, similar to the requirement
for dietary supplements (Sec. 101.36(b)(2)(i)(A)), all vitamins and
minerals declared on the Nutrition Facts label must include their
quantitative amounts (in addition to the requirement for corresponding
percent DV declaration) (proposed Sec. 101.9(c)(8)). We request
comments on this tentative conclusion, and seek input on the
appropriate placement of the quantitative amounts of nutrients on the
Nutrition Facts label.
Further, with the proposed requirement for declaration of absolute
amounts of vitamins and minerals, it is necessary to establish when a
vitamin or mineral is present in an insignificant amount as well as
increments for declaration of the quantitative amounts of vitamins and
minerals on the Nutrition Facts label. In determining requirements for
vitamins and minerals present in insignificant quantities, as well as
increments for declared vitamins and minerals, we looked to
requirements that have already been established for declaration of
quantitative amounts of sodium and potassium, vitamins and minerals
declared on the Supplement Facts label, and percent DVs.
Quantitative amounts in milligrams may currently be listed on the
Nutrition Facts label for only two minerals: Sodium, a mandatory
nutrient (Sec. 101.9(c)(4)) and potassium (Sec. 101.9(c)(5)), which
may be voluntarily declared on the Nutrition Facts label. We require in
Sec. 101.9(c)(4) and (c)(5) that when a serving contains less than 5
mg of sodium or potassium, the value shall be declared as zero; when a
serving contains 5 to 140 mg of sodium or potassium, the declared value
shall be rounded to the nearest 5 milligram increment; and when a
serving contains greater than 140 mg of sodium or potassium, the
declared value shall be rounded to the nearest 10 mg increment. We are
now proposing to establish an RDI for potassium. Since potassium will
now have an RDI, rather than a DRV, we are proposing to remove the
specific requirements for the declaration of potassium in Sec.
101.9(c)(5), and replace the section with requirements for the
declaration of fluoride. Requirements for the declaration of
quantitative amounts of other nutrients with an established RDI
discussed in this document will apply to potassium, if finalized.
The quantitative amounts by weight per serving of vitamins and
minerals are also required to be declared on the Supplement Facts label
(Sec. 101.36(b)(2)(ii)). The amounts of vitamins and minerals,
excluding sodium and potassium, that are declared on the Supplement
Facts label are the amount of the vitamin or mineral included in one
serving of the product, using the units of measurement and levels of
significance given in Sec. 101.9(c)(8)(iv). Section
101.36(b)(2)(ii)(B) also specifies that for declaration of vitamins and
minerals on the Supplement Facts label, zeros following decimal points
may be dropped, and additional levels of significance may be used when
the number of decimal places indicated is not sufficient to express
lower amounts (e.g., the RDI for zinc is given in whole mg, but the
quantitative amount may be declared in tenths of a mg).
For conventional foods, FDA specifies in Sec. 101.9(c)(8)(iii)
that the percent DV declaration for vitamins and minerals present at
less than 2 percent of the RDI is not required for nutrition labeling,
but may be declared as zero or by the use of an asterisk (or other
symbol) that refers to another asterisk (or symbol) that is placed at
the bottom of the table and that is followed by the statement
``Contains less than 2 percent of the Daily Value of this (these)
nutrient (nutrients).'' Alternatively, the statement ``Not a
significant source of (listing the vitamins or minerals omitted)'' may
be placed at the bottom of the table of nutrient values.
For the purpose of determining when a vitamin or mineral is present
in an insignificant amount, we tentatively conclude that the cutoff
used for declaration of percent DV of less than 2 percent of the RDI
(Sec. 101.9(c)(8)(iii)) can reasonably be applied to the declaration
of quantitative amounts of vitamins and minerals on the Nutrition Facts
label. We find that, if a product contains less than 2 percent of the
RDI per serving, it is appropriate to express the declared vitamin or
mineral quantitative amount as zero. The manufacturer may choose to use
an asterisk (or other symbol), instead of a declaration of zero, that
refers to another asterisk (or symbol) placed at the bottom of the
table and that is followed by the statement ``Contains less than 2
percent of the Daily Value of this (these) nutrient (nutrients).''
Alternatively, the statement ``Not a significant source of (listing the
vitamins or minerals omitted)'' (``not a significant source''
statement) may be placed at the bottom of the table of nutrient values.
As previously discussed, manufacturers have the option of using an
asterisk (or symbol), instead of a declaration of zero, that directs
the consumer to a statement indicating that the product is not a
significant source of certain vitamins or minerals found at the bottom
of the table of nutrient values when the calculated percent DV is less
than 2 percent. We are concerned that it may be confusing to consumers
if the manufacturer chooses to declare the quantitative amount of a
vitamin or mineral as zero, and also chooses to use an asterisk
referring the reader to a statement at the bottom of the label instead
of in the percent DV column on the Nutrition Facts label. Therefore, we
are proposing to require that, when a product contains less than 2
percent of the RDI for a vitamin or mineral, the manufacturer must
declare the quantitative amount of the vitamin or mineral and the
percent DV in the same manner. For example, if a serving of the product
contains less than 2 percent of the RDI for calcium, both the
quantitative amount and the percent DV for calcium may be listed as
zero or an asterisk (or symbol) directing the consumer to a statement
at the bottom of the label may be used in place of both the
quantitative amount and the percent DV declaration for calcium.
We see no reason to provide different declaration increments for
the Nutrition Facts label than those that have already been established
for the declaration of quantitative amounts of vitamins and minerals on
the Supplement Facts label in Sec. 101.36(b)(2)(ii). Therefore, we
tentatively conclude that, as with the declaration of quantitative
amounts of vitamins and minerals on the Supplement Facts label, the
levels of significance given in Sec. 101.9(c)(8)(iv) should be used.
Zeros following decimal points may be dropped, and additional levels of
significance may be used when the number of decimal places indicated is
not sufficient to express lower amounts (e.g., the RDI for zinc is
given in whole mg, but the quantitative amount may be declared in
tenths of a mg).
We acknowledge that for some vitamins and minerals with RDIs that
contain three or four digits (e.g., phosphorous has a proposed RDI of
1,250 mg), a difference of 1 mg per serving may not be meaningful in
terms

[[Page 11930]]

of health impacts. We request comment on whether quantitative amounts
for nutrients with RDI values that contain three or four digits should
be rounded, what the rounding increments should be, and data to support
suggested rounding increments for such vitamins and minerals.
7. Issues Concerning Specific Vitamins and Minerals
In this section, we address issues related to RDIs for specific
vitamins and minerals, including those received in comments to the 2007
ANPRM. We discussed the declaration of these vitamins and minerals in
section II.H. (and in accompanying Ref. 115).
a. Vitamin K--There are three general forms of vitamin K:
Phylloquinone (vitamin K1), menaquinone (vitamin
K2), and menadione (vitamin K3). For labeling
purposes, there is no specific definition for vitamin K. The AIs for
vitamin K are based on median intakes from NHANES data, which
specifically represents the intake of phylloquinone, the major form of
vitamin K in the diet (Ref. 134). The AI for vitamin K does not account
for the intake of menaquinone or menadione because (1) NHANES data only
includes phylloquinone content of foods, (2) the contribution of
menaquinones, which can be produced by bacteria in the gut, to the
maintenance of vitamin K status has not been established, and (3)
menadione is a synthetic form of vitamin K that can be converted to a
form of menaquinone in animal tissues. Because the AI for vitamin K is
specific to phylloquinone, our proposed RDI for vitamin K, 120 mcg in
proposed Sec. 101.9(c)(8)(iv), that is based on the AI pertains only
to phylloquinone.
b. Chloride--The RDI for chloride of 3,400 mg/d (Sec.
101.9(c)(8)(iv)) was established in 1995 and is based on the midpoint
of the range (1,700 to 5,100 mg/d) of the ESADDI set in the 1980 RDA
report (Ref. 135; 59 FR 427). The RDI for chloride is proportional to
the DRV for sodium, considering that chloride losses tend to parallel
losses of sodium and almost all dietary chloride comes from sodium
chloride (60 FR 67164). The IOM set AIs and ULs for chloride on an
equimolar basis to the AI and UL for sodium (Ref. 10). The 2007 ANPRM
requested comment on whether (1) the DV for chloride should continue to
be an RDI, or should be a DRV like the current DV for sodium and (2)
the DV for chloride should be based on the same DRI (AI versus UL) as
used to set a DV for sodium.
A few comments supported setting a DRV for chloride on an equimolar
basis to the UL for sodium. We disagree because the UL for chloride was
not based on adverse effects associated with excess intake of chloride.
Furthermore, the UL was not based on a public health endpoint specific
to chloride intake, which is a basis for setting a DRV. Because
chloride is an essential mineral and has age- and gender-specific AIs,
we tentatively conclude that chloride should remain a RDI and be based
on population-coverage AI (see section II.I.5.). Therefore, we are
proposing to set an RDI for chloride using the population-coverage AI
of 2,300 mg/d (proposed Sec. 101.9(c)(8)(iv)).
c. Potassium--The DRV of 3,500 mg/d for potassium was established
based on its beneficial health effects (e.g., reduction in blood
pressure) (55 FR 29487 at 29500). We established a DRV rather than an
RDI because an RDA for specific age and gender groups was not
established at that time. In 2005, the IOM established age- and gender-
specific AIs for potassium based on data showing that potassium lowers
blood pressure, blunts the adverse effects of sodium chloride intake on
blood pressure, reduces the risk of recurrent kidney stones, and
possibly decreases bone loss (Ref. 136). Because potassium is an
essential mineral and age- and gender-specific AIs are available, we
tentatively conclude that an RDI should be established in place of the
DRV. Therefore, using the population-coverage AI, we are proposing to
establish an RDI for potassium of 4,700 mg/d (proposed Sec.
101.9(c)(8)(iv)).
d. Choline--FDA regulations do not establish a reference value for
choline. In 1998, the IOM established age- and gender-specific AIs for
choline based on intakes necessary to maintain liver function (Ref.
137). In 2001, we received a FDAMA notification under section
403(r)(2)(G) of the FD&C Act for the use of certain nutrient content
claims for choline (Ref. 138). The FDAMA notification identified the DV
for choline as 550 mg, which was based on the population-coverage AI
for choline. Because the IOM established age- and gender-specific AIs
for choline, we tentatively conclude that an RDI should be established.
Thus, we are proposing in Sec. 101.9(c)(8)(iv) to set an RDI of 550 mg
for choline based on the population-coverage AI.
e. Vitamin B12--We are proposing to lower the RDI for
Vitamin B12 from 6 to 2.4 [mu]g/day which reflects the
population-coverage RDA for Vitamin B12. The RDAs for
Vitamin B12 were established by the IOM in 2000. The IOM
noted that 10 to 30 percent of individuals older than 50 years of age
are estimated to have atrophic gastritis with low stomach acid
secretion which can decrease the bioavailability of naturally occurring
vitamin B12 in food (Ref. 17). The bioavailability of
crystalline vitamin B12 that is added to food is not altered
in people with this condition. While the IOM set an RDA of 2.4 [mu]g/d
that can be met by consuming natural and crystalline forms of vitamin
B12 and is for all adults, it was noted that it is advisable
that individuals older than 50 years of age meet their RDA mainly by
consuming foods fortified with crystalline vitamin B12 or
vitamin B12-containing supplements. If the RDI is lowered
from 6 to 2.4 [mu]g, it is possible that the fortification level in
foods, such as ready-to-eat breakfast cereals, may be lowered,
decreasing the overall amount of crystalline vitamin B12 in
the food supply. Given the current level of fortification in food, less
than 1 percent of men and 6.4 to 7.5 percent of women older than 50
years of age consume below the EAR for vitamin B12, while
only 3 to 5 percent of men and women in this age group have serum
vitamin B12 levels that are considered to be inadequate
(2003-2006 NHANES) (table 1). Reflecting the current food supply and
regulations, data from NHANES (2003-2006) indicate that ready-to-eat
cereal is the primary source of crystalline B12 added to
food, providing approximately 14.6 percent of the total vitamin
B12 consumed by individuals 51 years of age and older (Ref.
139). Dietary supplements appear to be an important contributor of
vitamin B12 for this age group because the mean increase in
vitamin B12 intake ranged between 2.5 and 4.7 [mu]g/d when
comparing intake from food only compared to food plus dietary
supplements (NHANES 2003-2006) (table 1). We request comment and data
on lowering the RDI for vitamin B12 to 2.4 [mu]g.

[[Page 11931]]

Table 2--Current and Proposed RDIs for Nutrition Labeling
[Based on a 2,000 calorie intake for adults and children 4 or more years of age]
----------------------------------------------------------------------------------------------------------------
Nutrient Current RDIs Proposed RDIs
----------------------------------------------------------------------------------------------------------------
Vitamins:
Biotin............................ 300 micrograms................ 30 micrograms.
Choline........................... 550 \1\ milligrams............ 550 milligrams.
Folate............................ 400 micrograms................ 400 micrograms DFE.
Niacin............................ 20 milligrams................. 16 milligrams NE.
Pantothenic acid.................. 10 milligrams................. 5 milligrams.
Riboflavin........................ 1.7 milligrams................ 1.3 milligrams.
Thiamin........................... 1.5 milligrams................ 1.2 milligrams.
Vitamin A......................... 5,000 International Units..... 900 micrograms RAE.
Vitamin B6........................ 2.0 milligrams................ 1.7 milligrams.
Vitamin B12....................... 6 micrograms.................. 2.4 micrograms.
Vitamin C......................... 60 milligrams................. 90 milligrams.
Vitamin D......................... 400 International Units....... 20 micrograms.
Vitamin E......................... 30 International Units........ 15 milligrams.
Vitamin K......................... 80 micrograms................. 120 micrograms.
Minerals:
Calcium........................... 1,000 milligrams.............. 1,300 milligrams.
Chloride.......................... 3,400 milligrams.............. 2,300 milligrams.
Chromium.......................... 120 micrograms................ 35 micrograms.
Copper............................ 2.0 milligrams................ 0.9 milligrams.
Iodine............................ 150 micrograms................ 150 micrograms.
Iron.............................. 18 milligrams................. 18 milligrams.
Magnesium......................... 400 milligrams................ 420 milligrams.
Manganese......................... 2.0 milligrams................ 2.3 milligrams.
Molybdenum........................ 75 micrograms................. 45 micrograms.
Phosphorus........................ 1,000 milligrams.............. 1,250 milligrams.
Potassium \2\..................... 3,500 milligrams.............. 4,700 milligrams.
Selenium.......................... 70 micrograms................. 55 micrograms.
Zinc.............................. 15 milligrams................. 11 milligrams.
----------------------------------------------------------------------------------------------------------------
RAE = Retinol activity equivalents; 1 RAE = 1 mcg retinol, 12 mcg [beta]-carotene, or 24 mcg [alpha]- carotene,
or 24 mcg [beta]-cryptoxanthin.
NE = Niacin equivalents, 1 mg niacin = 60 mg of tryptophan.
DFE = Dietary folate equivalents; 1 DFE = 1 mcg food folate = 0.6 mcg of folic acid from fortified food or as a
supplement consumed with food.
\1\ A notification was submitted under section 403(r)(2)(G) of the FD&C Act in 2001 for the use of certain
nutrient content claims for choline. These statements identify the daily value for choline as 550 mg. This
value is based on the AI set by the IOM of the NAS in 1998 (Refs. 138 and 137).
\2\ These minerals currently have a DRV and we are proposing to establish an RDI.

J. Units of Measure, Analytical Methods, and Terms for Vitamins and
Minerals

As discussed in this document, the IOM set DRIs using new units of
measure for vitamin A, vitamin E, and folate, as well as provided
recommendations on the use of International Units (IUs), and expression
of weight amounts for sodium, potassium, copper, and chloride (Refs. 17
to 19,25). The new units of measure for vitamin A, vitamin E, and
folate affect how total amount of each nutrient is measured. The 2007
ANPRM asked several questions about these issues. We discuss our
reconsideration of the units of measure, analytical methods, and terms
used in declaration of specific vitamins and minerals in this section.
1. Sodium, Potassium, Copper, and Chloride
The absolute amount declaration for sodium, potassium, copper, and
chloride must be expressed in mg (Sec. 101.9(c)(8)(iv) and (c)(9)).
However, in the DRI reports for these nutrients, these nutrients are
expressed as grams (sodium, potassium, chloride) or micrograms (copper)
(Refs. 21,140). The IOM Labeling Committee recommended that the current
requirement for units of measurement used in the declaration of these
nutrients should be changed to be consistent with the units used in the
new DRI reports. In response to the 2007 ANPRM that asked about whether
the units of measure should be changed for these nutrients, we received
comments that generally supported maintaining the current units of
measure.
We considered the IOM Labeling Committee recommendations and
comments received. When expressed as ``g'' units, rather than in ``mg''
units, significant differences in the amounts of sodium or potassium
could appear inconsequential or less significant. For example, amounts
declared as 0.2 g and 0.5 g may not seem as significantly different as
200 mg and 500 mg. Furthermore, units of measure for these nutrients
have been in use since 1993 and consumers may be already familiar with
the units used on the label. In addition, the use of milligrams for
sodium and potassium is consistent with the 2010 DGA, which provides
recommendations for sodium and potassium in milligram units (Ref. 6).
We tentatively conclude that there is no advantage to change the units
of measure for sodium, potassium, copper, or chloride from those
currently in use. Thus, we are not proposing any changes to the units
used for declaring these nutrients on the Nutrition Facts label.
2. Folate and Folic Acid
a. Units of Measure--The RDI for ``folate'' is listed in
``micrograms'' (Sec. 101.9(c)(8)(iv)). Folate represents the sum of
naturally occurring folate and synthetic folic acid that has been added
to foods. In 1998, the IOM set the RDA for folate expressed as mcg
Dietary Folate Equivalents (DFE) (Ref. 141). The IOM Labeling Committee
recommended that the units used for folate (mcg) in nutrition labeling
should be consistent with the units in the new DRI report (mcg DFE)
(Ref. 25). In response to the 2007 ANPRM, in which we asked for comment
on this issue, a few comments supported retaining the current units
(mcg) for folate and one comment noted

[[Page 11932]]

that the use of the term DFE on the label would be unfamiliar to
consumers and could be confusing (Ref. 47). The IOM developed the new
term, DFE, to account for the greater bioavailability of synthetic
folic acid that is added to fortified foods or dietary supplements than
folate that occurs naturally in foods (food folate). As defined by the
IOM, mcg DFE is equivalent to mcg food folate + (1.7 x mcg synthetic
folic acid) (Ref. 141). The current unit of measure (mcg) does not take
into account the difference in the bioavailability of folate and folic
acid. In addition, mcg DFE declaration would provide a more accurate
representation of the amount of folate in foods that contain both
naturally occurring folate and added folic acid. For example, the
standards of identity for certain enriched foods require the addition
of folic acid (21 CFR parts 136, 137, and 139) and, these foods contain
both food folate and synthetic folic acid.
Therefore, we are proposing to amend Sec. 101.9(c)(8)(iv) such
that mcg DFE would be used to declare the amount of total folate (food
folate and synthetic folic acid) on the Nutrition Facts label. Section
101.36(b)(2)(ii)(B) for the labeling of dietary supplements includes a
reference to Sec. 101.9(c)(8)(iv), which, as proposed, designates the
units of measure for declaration of folic acid as mcg DFE units (see
section II.L.).
We are aware that education efforts should be provided to assist
with consumer understanding of the new ``equivalent'' units of
measurement for folic acid. For example, using the new units, a dietary
supplement that now declares 400 mcg of folic acid would declare the
same amount as 680 mcg DFE or 170 percent of the proposed RDI. One
option to help ensure consumer understanding would be to allow the
declaration of the amount of folic acid in parenthesis similar to that
permitted for the percent of vitamin A as [beta]-carotene (Sec.
101.9(c)(8)(vi)). For example, for a conventional food that contains
both folic acid and folate, the total mcg DFE could be declared and in
parenthesis indicate how much is from folic acid. We invite comment on
this approach.
b. Analytical Methods--Because we are proposing to amend the units
used for declaring the sum of folate and folic acid, we considered the
availability and limitations of analytical methods necessary to measure
each nutrient separately for calculating mcg DFE. Available analytical
methods (e.g., AOAC 960.46, 944.12, and 2004.05) cannot distinguish
between naturally occurring folate in conventional food and folic acid
that is added to conventional food products. There is a difference in
folate activity between naturally occurring folate and synthetic folic
acid that is added to fortify foods. When a conventional food product
contains a mixture of naturally occurring folate and synthetic folic
acid that has been added, available analytical methods do not allow for
verification of the declared amount of mcg DFEs on the Nutrition Facts
label. To calculate DFEs, it is necessary to know both the amount of
folate and folic acid in the food product. Therefore, proposed Sec.
101.9(g)(10) would require manufacturers to make and keep records to
verify the amount of folic acid added to the food and folate in the
finished food, when a mixture of both naturally occurring folate and
added folic acid are present in the food. (See section II.N.) We invite
comment on available scientifically valid methods that are capable of
measuring folic acid and folate separately.
c. Terms to Declare Folate--''Folic acid'' or ``folacin'' are
identified as synonyms of folate and can be added in parentheses after
folate or can be listed without parentheses in lieu of ``folate'' on
the Nutrition Facts label (Sec. 101.9(c)(8)(v)) or in the Supplement
Facts label (Sec. 101.36(b)(2)(B)(2)).
Consistent with the proposed amendments related to the units of
measure for folate that take into account the differences between
folate and folic acid, we are reconsidering appropriate terms for
declaration of folate content in foods and dietary supplements. We are
proposing to (1) eliminate the synonym ``folacin'' specified in
Sec. Sec. 101.9(c)(8)(v) and 101.36(b)(2)(B)(2); (2) require, in
proposed Sec. 101.9(c)(8)(vii), that the term ``folate'' be used in
the labeling of conventional foods that contain either folate only or a
mixture of folate and folic acid; and (3) require that the term ``folic
acid'' be used in the labeling of dietary supplements only. As
proposed, conventional foods would not be permitted to use the term
``folic acid.''
3. Vitamins A, D, and E
International Units (IUs) are used for the labeling of vitamins A,
D, and E on the Nutrition and Supplements Facts labels (Sec. Sec.
101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B)). The IOM Labeling Committee
recommended that the units for these nutrients should be changed to be
consistent with the units in the new DRI reports, i.e., [mu]g Retinol
Activity Equivalents for vitamin A, [mu]g for vitamin D, and mg
[alpha]-tocopherol for vitamin E (Refs. 18,22,25,140). In response to
the 2007 ANPRM, several comments supported replacing IUs with mcg RAE
for vitamin A, [mu]g for vitamin D, and mg [alpha]-tocopherol for
vitamin E. We agree that IUs should be replaced with units that are
consistent with the DRIs. In addition, because DRIs form the basis for
the proposed RDIs for these vitamins (see section II.I.), using the new
units would also correspond with the proposed RDIs for vitamins A, D,
and E. We discuss issues relevant to vitamin A and vitamin E units of
activity in this document.
a. Units of Vitamin A Activity--The RDI for vitamin A is 5,000 IU
(Sec. 101.9(c)(8)(iv)). Because the vitamin A activity of provitamin A
carotenoids (e.g., [beta]-carotene) is less than pre-formed vitamin A
(retinol), the following conversions were developed: One mcg retinol =
3.33 IU vitamin A activity from retinol (Ref. 105) and 10 IU [beta]-
carotene = 3.33 IU retinol (Ref. 105). Because the vitamin A activity
of [beta]-carotene in dietary supplements is greater than [beta]-
carotene in food, ten IU of [beta]-carotene is based on 3.33 IU of
vitamin A activity x 3 (the relative vitamin A activity of [beta]-
carotene in supplements versus diets). The RDA in mcg Retinol
Equivalents (RE) for vitamin A is equivalent to 1 mcg retinol or 6 mcg
of [beta]-carotene (i.e., carotene:retinol equivalency ratio of 6:1)
and considers 3 mcg of dietary [beta]-carotene to be equivalent to 1
mcg of purified [beta]-carotene in supplements (i.e., a
carotene:retinol equivalency ratio of 3:1).
A comment to the 2007 ANPRM noted that the IU for vitamin A does
not take into account the recent information on the bioavailability of
dietary provitamin A carotenoids that was used to define retinol
activity equivalents (RAEs) for these carotenoids (Ref. 105). The unit
of measure associated with the RDA for vitamin A is mcg RE. We agree
that the IU for vitamin A does not reflect the carotene:retinol
equivalency ratio. RAEs consider 6 mcg of dietary [beta]-carotene to be
equivalent to 1 mcg of purified [beta]-carotene in supplements (i.e., a
carotene:retinol equivalency ratio of 6:1) because more recent evidence
suggests that the bioavailability of [beta]-carotene is approximately
half of what was previously considered for setting mcg RE. A change in
units does not present any challenges to AOAC methods used for
measuring provitamin A carotenoids and vitamin A in foods or dietary
supplements.
Therefore, proposed Sec. 101.9(c)(8)(iv) would change the units of
measure for vitamin A to replace ``IU'' with ``mcg,'' representing mcg
RAE. In addition, because the difference in the bioconversion of
[beta]-carotene to vitamin A will be accounted for with the proposed
declaration of vitamin A content as ``mcg'' (representing mcg

[[Page 11933]]

RAE), we are not proposing to preclude the declaration of [beta]-
carotene in conventional foods as vitamin A. A corresponding change for
dietary supplements is made in proposed Sec. 101.36(b)(2)(i)(B)(3).
b. Units of Vitamin E Activity--The RDI for vitamin E is 30 IU
(Sec. 101.9(c)(8)(iv)). Before 1980, one IU of vitamin E activity was
defined as 1 mg of dl-[alpha]-tocopherol acetate by the U.S.
Pharmacopeia (USP) (Ref. 142). After 1980, the IU was changed to the
USP unit where one USP unit of vitamin E was still defined as having 1
mg of all rac-[alpha]-tocopherol acetate. Therefore there is no longer
an IU for vitamin E (Ref. 142). One comment to the 2007 ANPRM said that
the current RDI of 30 IU underestimates the amount of vitamin E
naturally present in foods. We agree. The RDA for vitamin E is 15 mg/d
of [alpha]-tocopherol (Ref. 143). [alpha]-Tocopherol is the only form
of vitamin E that is maintained in blood and has biological activity.
There are eight stereoisomers of [alpha]-tocopherol (RRR, RSR, RRS,
RSS, SRR, SSR, SRS, SSS). Of the eight, only RRR [alpha]-tocopherol
occurs naturally in foods. Commercially available vitamin E that is
used to fortify foods and used in dietary supplements contains esters
of either the natural RRR- or, more commonly, mixtures of the 8
stereoisomers (all rac [alpha]-tocopherol acetate). Four of the eight
stereoisomers of [alpha]-tocopherol are not maintained in human plasma
or tissues (SRR, SSR, SRS, and SSS). Thus, the new RDA for vitamin E is
limited to the four 2R stereoisomeric forms (RRR, RSR, RRS and RSS) of
[alpha]-tocopherol (Ref. 143). These four forms of [alpha]-tocopherol
are found in nonfortified and fortified conventional foods and dietary
supplements. The all rac-[alpha]-tocopherol acetate in fortified foods
or dietary supplements has one-half the activity of RRR-[alpha]-
tocopherol naturally found in foods or the 2R stereoisomeric forms of
[alpha]-tocopherol. Unlike the IU, the new IOM measure of vitamin E
activity, mg [alpha]-tocopherol accounts for this difference in
activity between naturally occurring and synthetic vitamin E.
Therefore, proposed Sec. 101.9(c)(8)(iv) would change the units of
measure for vitamin E to replace ``IU'' with ``mg,'' representing mg of
[alpha]-tocopherol. Section 101.36(b)(2)(ii)(B) for the labeling of
dietary supplements includes a reference to Sec. 101.9(c)(8)(iv),
which, as proposed, designates the units of measure for declaration of
vitamin E as ``mg.''
Because of the difference in vitamin E activity between all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol, AOAC methods or
other validated analytical methods would be needed for individually
measuring naturally occurring vitamin E (RRR-[alpha]-tocopherol) and
all rac-[alpha]-tocopherol acetate in food products. Current AOAC
methods cannot individually measure these two forms of vitamin E. In
addition, it is necessary to know the amount of both RRR-[alpha]-
tocopherol and all rac-[alpha]-tocopherol acetate in a food product to
calculate vitamin E equivalents for declaration as mg [alpha]-
tocopherol. It is not possible to determine the amount of RRR-[alpha]-
tocopherol in a food product by subtracting the amount of all rac-
[alpha]-tocopherol acetate from the total amount of vitamin E declared.
Therefore, when a conventional food contains a mixture of all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol, we are proposing
to require manufacturers to verify the declared amount of both all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol in the finished
food product (proposed Sec. 101. 9(g)(10)). (See section II.N.) We
invite comment on available validated methods that are capable of
individually measuring all rac-[alpha]-tocopherol acetate and RRR-
[alpha]-tocopherol.
For the reasons stated previously, we are proposing to amend Sec.
101.9(c)(8)(iv) to replace IUs for the RDIs for vitamin A, vitamin D,
and vitamin E with mcg RAE for vitamin A, [mu]g for vitamin D, and mg
[alpha]-tocopherol for vitamin E.

K. Labeling of Foods for Infants, Young Children, and Pregnant or
Lactating Women

The general labeling requirements for foods in Sec. 101.9(c) apply
to foods for infants, young children, and pregnant and lactating women
with certain exceptions. For example, foods, other than infant formula,
represented or purported to be specifically for infants and children
less than 4 years of age are not permitted to include declarations of
percent DV for the following nutrients: Total fat, saturated fat,
cholesterol, sodium, potassium, total carbohydrate and dietary fiber
(Sec. 101.9(j)(5)(ii)(A)). There are additional exceptions to labeling
for foods, other than infant formula, represented or purported to be
specifically for infants and children less than 2 years of age. For
example, these foods are also not permitted to declare calories from
fat, calories from saturated fat, saturated fat, polyunsaturated fat,
monounsaturated fat and cholesterol on the Nutrition Facts label (Sec.
101.9(j)(5)(i)).
FDA regulations do not include DRVs or RDIs for nutrients,
generally, for infants, children under 4 years of age, or pregnant and
lactating women. However, there are requirements for a DRV for protein
for children 4 or more years of age, and an RDI for protein for each of
the following subpopulations: (1) Children less than 4 years of age;
(2) infants; (3) pregnant women; and (4) lactating women (Sec.
101.9(c)(7)(iii)). In the preamble to the 1993 DRV/RDI final rule, we
included a table listing RDIs for various nutrients for these
subpopulations, based on the 1968 NAS RDAs (58 FR 2206 at 2213). These
RDIs also appear in FDA's Food Labeling Guide (Ref. 144) and we are
aware that some manufacturers use these RDIs in labeling foods
represented or purported to be specifically for these subpopulations.
We are reconsidering the requirements for the labeling of foods,
other than infant formula, represented or purported to be specifically
for infants, children under 4 years of age, and pregnant and lactating
women, in light of current recommendations in consensus reports and
proposed changes to the Nutrition Facts label discussed in sections
II.A. to II.J., and comments to the 2007 ANPRM. We are proposing
various changes, which we discuss in this document.
1. Age Range for Infants and Young Children
FDA regulations use the age ranges ``less than 2 years of age'' and
``less than 4 years of age'' to establish labeling requirements for
foods represented or purported to be specifically for infants and young
children (Sec. 101.9(j)(5)). The 2007 ANPRM did not ask for comments
on this issue, but several comments (Ref. 47) recommended that we
change the current age categories to infants 7 to 12 months and young
children 1 through 3 years (13 through 48 months), consistent with the
age ranges used in the IOM's age-specific DRI recommendations.
In general, we consider it appropriate to adopt the same age
categories as those used in the IOM DRIs for infants and children
because our proposed DVs are based on these age-specific DRIs. With
respect to the infant category, the nutritional requirements of infants
0 to 6 months should be met almost exclusively by breast milk or infant
formula (Refs. 145 and 146). Therefore, regulations for the labeling of
foods, other than infant formula, represented or purported to be
specifically for infants 0 to 6 months of age are not necessary or
appropriate. However, infants are transitioning to eating solid foods
by 7 through 12 months. There are a number of foods in the marketplace
identified for this age group. Therefore, we are proposing a separate
category of foods represented or purported to be

[[Page 11934]]

specifically for infants 7 through 12 months.
With respect to children 1 through 3 years of age, using the DRI
age range would result in infants no longer being the lower end of the
age range in the category of infants and children less than 2 years and
less than 4 years of age as specified in Sec. 101.9(j)(5). Young
children who are 1 year of age would be the lower end of the age range.
Assigning DVs for children 1 through 3 years of age would ensure
consistency with the 1 through 3 year toddler age category established
for RACCs specified in Sec. 101.12(a)(2). Moreover, because the growth
velocity in height is most similar for children 1 through 3 years of
age, we consider it appropriate to revise the age range to include
children of these ages into a single category for food labeling
purposes (Ref. 15).
Therefore, we are proposing to revise the exceptions for
requirements for nutrition labeling provided in Sec. 101.9(j)(5)(i)
and the exception to the requirement for the format used for nutrient
information on food labeling in Sec. 101.9(d)(1) for foods represented
or purported to be specifically for infants and children less than 4
years of age. Specifically, we are proposing to replace the current
category of infants and children less than 4 years with infants 7
through 12 months and children 1 through 3 years of age.
2. Mandatory Declaration of Calories and Statutorily Required Nutrients
Currently, foods, other than infant formula, represented or
purported to be specifically for infants and children less than 4 years
must declare statutorily required nutrients, including calories,
calories from fat, total fat, saturated fat, cholesterol, sodium, total
carbohydrate, sugars, dietary fiber, and protein. For foods, other than
infant formula, represented or purported to be for infants and children
less than 2 years, the declaration of certain statutorily required
nutrients, which include calories from fat, saturated fat, and
cholesterol, is not required or permitted (Sec. 101.9(j)(5)(i)).
a. Declaration of Saturated Fat and Cholesterol--One comment to the
2007 ANPRM noted that the diet of U.S. infants is nutritionally
adequate with negligible risk of nutrient deficiency and recommended
continuing to require the declaration of calories and the amount of
total fat, total carbohydrate, dietary fiber, sugars, and total protein
on the Nutrition Facts label of foods for infants. Another comment
supported mandatory declaration of saturated fat on food products for
children less than 2 years of age.
As discussed in section II.K.1., we are proposing new categories of
infants 7 through 12 months and children 1 through 3 years of age. We
are considering, in this proposed rule, whether there is a need to
require or permit the declaration of calories from fat, saturated fat,
and cholesterol in the labeling for foods represented or purported to
be specifically for these subpopulations. In section II.A.1., we
discuss our intent to revise Sec. 101.9(c)(1)(ii) to no longer require
and not permit the declaration of calories from fat on the Nutrition
Fact label. Therefore, if these proposed changes are finalized, the
exceptions in Sec. 101.9(j)(5)(i) would no longer be needed.
With respect to saturated fat and cholesterol, we did not require
or permit the labeling of any fat or fatty acid on foods represented or
purported to be specifically for children less than 2 years because
consensus reports noted the need for the higher percentage of calories
from fat for this subpopulation and that nutrient guidelines on fats,
cholesterol and calories for children less than 2 years of age is
inappropriate (58 FR 2079 at 2150). A recent consensus report continues
to recommend that fat intake in infants less than 12 months of age
should not be restricted; however, there is no discussion or
recommendation about not providing nutrient guidelines for fat and
cholesterol to children under the age of 2 years (Ref. 146). While fat
is still considered to be an important source of calories for infants
and young children, recent evidence suggests that a diet with saturated
fat less than 10 percent of calories and cholesterol intake less than
300 mg/d can safely and effectively reduce the levels of total and LDL
cholesterol in healthy children (Ref. 146). This type of diet may have
similar effects when started in infancy and sustained throughout
childhood into adolescence (Ref. 146). Furthermore, the 2010 DGA
recommended that Americans 2 years of age and older consume less
saturated fatty acids and less than 300 mg/d of cholesterol (Ref. 6).
We tentatively conclude that, except for the declaration of
calories from fat, the declaration of statutorily required nutrients
that include saturated fat and cholesterol on the label of foods
represented or purported to be specifically for infants 7 through 12
months and children 1 through 3 years of age should be mandatory
because: (1) The declaration of calories and these nutrients is
mandated by section 403(q) of the FD&C Act and we have no basis on
which to not require or permit their declaration as discussed
previously; and (2) these nutrients are essential in fostering growth
and maintaining good health during a critical stage of human
development and physiology (Ref. 147 p. 71) and, therefore, their
mandatory declaration can assist in maintaining healthy dietary
practices. Therefore, we are proposing to remove current Sec.
101.9(j)(5)(i) and revise and re-designate current Sec.
101.9(j)(5)(ii) as Sec. 101.9(j)(5)(i).
We request comment on our tentative conclusions and any available
relevant empirical research as to whether the proposed declaration of
saturated fat and cholesterol for these subpopulations is likely to be
confusing to consumers or otherwise result in restriction of fat
intakes among infants 7 through 12 months or children 1 through 3 years
of age.
Currently, foods consumed by pregnant and lactating women must
declare statutorily required nutrients, including calories, calories
from fat, total fat, saturated fat, cholesterol, sodium, total
carbohydrate, sugars, dietary fiber, and protein. Women of reproductive
age consume the same foods as the general population and, in general,
continue consuming similar foods during pregnancy and lactation. We
tentatively conclude that, except for the declaration of calories from
fat, the declaration of statutorily required nutrients should be
mandatory because the declaration of calories and these nutrients is
mandated by section 403(q) of the FD&C Act and we have no basis on
which to not require or permit their declaration as discussed
previously.
Accordingly, we are proposing to require the mandatory declaration
of calories, and the amount of total fat, saturated fat, trans fat,
cholesterol, sodium, total carbohydrate, dietary fiber, sugars, and
protein on foods represented or purported to be specifically for
infants 7 through 12 months of age, children 1 through 3 years of age,
and pregnant and lactating women, and permit the declaration of
calories from saturated fat such that these nutrients would be subject
to the same requirements applicable to foods for the general
population.
A comment to the 2007 ANPRM requested that we permit the use of a
footnote statement about not limiting fat intake on foods represented
or purported to be specifically for infants and children less than 2
years to enable consumers to make informed choices, should the Agency
decide to propose the mandatory declaration of saturated fat for
infants and children less than 2

[[Page 11935]]

years. The comment noted that saturated fat should not be limited in
the diets of children less than 2 years of age. The comment provided no
consumer data about such a footnote statement. At this time, we are not
proposing to require a footnote stating that total fat and other types
of fat should not be limited in infants and children less than 2 years
in response to this comment. However, we request comments and
information on how consumers would understand and use the amount of
saturated fat and cholesterol declared on the Nutrition Facts label, as
well as on the need for an explanatory footnote to accompany the
declaration of saturated fat and cholesterol, on foods represented or
purported to be specifically for infants 7 through 12 months or
children 1 through 3 years.
b. Percent DV Declaration--Currently, the percent DV declaration is
not permitted on the food label for foods, other than infant formula,
represented or purported to be specifically for infants and children
less than 4 years (which includes infants and children less than 2
years) for total fat, saturated fat, cholesterol, sodium, potassium,
total carbohydrate, and dietary fiber (Sec. 101.9(j)(5)(ii)). Percent
DV is required for protein and vitamins and other minerals. We
tentatively conclude that it is appropriate to require declarations of
percent DV for those nutrients for which we are establishing a DRV or
RDI for infants 7 to 12 months, for children 1 through 3 years of age,
and for pregnant and lactating women (see the discussion in this
document for the nutrients in each subpopulation for which FDA is
establishing a DRV or RDI). This change is reflected in re-designated
Sec. 101.9(j)(5)(i). The percent DV, as discussed in section II.B.3.,
provides information in a manner which enables consumers to understand
the relative significance of nutrition information in the context of a
total daily diet.
One comment to the 2007 ANPRM suggested that the percent DV
declaration for protein should be voluntary for all infant products,
unless a claim is made for protein because protein intake and quality
appear to be adequate for infants (Refs. 148 and 149). As we previously
stated, protein is of critical importance in maintaining good health
because it supplies essential amino acids and is a principal source of
calories along with fat and carbohydrate (55 FR 29487 at 29499).
Current evidence suggests that protein intake is adequate in infants
and young children and the majority of protein sources in their diets
constitute high quality protein sources (Ref. 150). However, the level
and quality of protein present in a food remain an important
consideration in food selection for infants because infant diets are
derived from a limited number of foods (55 FR 29487 at 29499). For
example, at 6 to 11 months of age, approximately 46 percent of the
total protein intake comes from sources other than breast milk,
formula, and cow's milk (e.g., baby foods and meats) (Ref. 149). The
percentage increases at ages 12 to 24 months to 63 percent (Ref. 149).
Calculating the percent DV for protein incorporates a measure of
protein quality (e.g., a corrected protein amount obtained from the
protein digestibility-corrected amino acid score) (Sec. 101.9
(c)(7)(i)). Thus, the percent DV declaration is a useful tool to
indicate protein quality to the consumer. As such, we disagree that the
percent DV declaration for protein should be voluntary. Because of the
importance of adequate high quality protein in the diets of infants and
young children, we tentatively conclude that the percent DV declaration
for protein is necessary to assist consumers in maintaining healthy
dietary practices among infants and young children 1 through 3 years of
age.
3. Declaration of Non-Statutory Nutrients Other Than Essential Vitamins
and Minerals
Foods, other than infant formula, represented or purported to be
specifically for infants and children less than 2 years of age are not
permitted to declare calories from saturated fat and the amount of
polyunsaturated fat and monounsaturated fat (Sec. 101.9(j)(5)(i)),
whereas soluble fiber, insoluble fiber, and sugar alcohols can be
voluntarily declared. Polyunsaturated fat, monounsaturated fat, soluble
fiber, insoluble fiber, and sugar alcohols can be voluntarily declared
on the label of foods represented or purported to be specifically for
children 2 through 4 years of age, and pregnant and lactating women.
Section I.C. includes a discussion of the factors that we consider
in proposing the requirements for declaration of non-statutorily
required nutrients on the Nutrition Facts label of foods (e.g.,
polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble
fiber, and sugar alcohols). These factors include the availability of
information from consensus reports, including evidence for the public
health significance of a nutrient. Consensus reports that provide
information about the relationship between nutrients and chronic
diseases, heath-related conditions, or health-related physiological
endpoints are generally not available for infants 7 to 12 months.
Therefore, for foods represented or purported to be for these infants,
we are not considering consensus reports in the way described in
section I.C., but, rather, we are considering other types of
information that are available from consensus reports applicable to
this subpopulation. With respect to certain nutrition declaration
requirements, we determined there was not sufficient evidence to
propose a change to the regulations. In addition, we determined that,
in some cases, there is not sufficient evidence to propose different
requirements for foods represented or purported to be specifically for
infants 7 through 12 months than for foods represented or purported to
be specifically for children 1 through 3 years of age.
For foods represented or purported to be specifically for children
1 through 3 years of age and pregnant and lactating women, we
considered the factors in section I.C. to determine whether to propose
the mandatory or voluntary declaration of non-statutory nutrients. Most
advisory consensus and policy reports on which we rely for the general
population apply to children 2 years of age and older and pregnant and
lactating women, unless noted otherwise (e.g., 2010 DGAC and health
claims (Sec. 101.14(e)(5)). While the recommendations in these reports
are for 2 years of age and older, we are using the information in these
consensus reports for considering the factors in section I.C. for
children 1 through 3 years of age because it is not expected that the
role of these nutrients in health would be markedly different between 1
and 2 year olds. Moreover, the IOM has established the DRI ranges for 1
to 3 year olds.
a. Voluntary Declaration of Calories From Saturated Fat, and the
Amount of Polyunsaturated and Monounsaturated Fat--For infants 7 to 12
months, there are no specific recommendations provided about calories
from saturated or polyunsaturated or monounsaturated fat. However, as
discussed previously, there is some evidence to suggest that reduction
of total and LDL cholesterol levels can occur with reducing saturated
fat intake to less than 10 percent of calories, beginning in infancy
and sustained throughout childhood into adolescence (Ref. 146).
Furthermore, consensus reports provide no discussion or recommendation
about not providing nutrient guidelines for fatty acids to children
under the age of 2 years and there is no evidence to suggest that
infants 7 through 12 months of age would be different than children 1

[[Page 11936]]

through 3 years of age. Therefore, we tentatively conclude that there
is no basis to continue to provide an exception that does not permit
the declaration of calories from saturated fat, or polyunsaturated and
monounsaturated fats on foods represented or purported to be
specifically for infants and children less than 2 years of age.
Quantitative intake recommendations are not available from relevant
U.S. consensus reports for monounsaturated and polyunsaturated fats for
children 1 through 3 years of age or pregnant and lactating women.
There is well-established evidence to indicate that replacing saturated
fatty acids with polyunsaturated and monounsaturated fatty acids
reduces blood LDL cholesterol levels and, therefore, the risk of CVD
(Ref. 6). Because monounsaturated and polyunsaturated fats have public
health significance when they replace saturated fat, consistent with
the factors we consider for voluntary declaration discussed in section
I.C., we tentatively conclude that not permitting the declaration of
polyunsaturated and monounsaturated fat on foods represented or
purported to be specifically for children less than 2 years of age in
Sec. 101.9(j)(5)(i) is no longer necessary.
Therefore, we are proposing to revise Sec. 101.9(j)(5)(i) to
remove the exceptions for the declaration of calories from saturated
fat, and the amount of polyunsaturated fat and monounsaturated fat on
foods represented or purported to be specifically for children less
than 2 years of age. If finalized, these declarations would be the same
as the proposed voluntary declarations for foods for the general
population (see sections II.A.2, II.B.4, and II.B.5., respectively).
b. Voluntary Declaration of Soluble Fiber, Insoluble Fiber, and
Sugar Alcohols--As discussed in section II.D., while quantitative
intake recommendations are lacking for soluble fiber, insoluble fiber,
and sugar alcohols, there is well established evidence for the role of
these nutrients in chronic disease risk, risk of a health-related or a
physiological endpoint (i.e., CHD, laxation or dental caries) (Ref. 66
and Sec. Sec. 101.76, 101.77, 101.80, and 101.81). There is no
evidence to suggest that the role of these nutrients would be different
among infants 7 through 12 months, children 1 through 3 years of age,
or pregnant and lactating women compared to the general population.
Accordingly, we are not proposing any changes to the provisions for
the voluntary declaration of soluble fiber, insoluble fiber, and sugar
alcohols on the label of foods represented or purported to be
specifically for infants 7 to 12 months, children 1 through 3 years of
age, or pregnant and lactating women.
c. Mandatory Declaration of Trans Fat--Trans fat is required to be
declared on the Nutrition Facts label and regulations do not provide
exceptions for foods represented or purported to be specifically for
infants, young children, or pregnant and lactating women. One comment
to the 2007 ANPRM recommended eliminating mandatory trans fat labeling
when total fat is declared as 0 g in the Nutrition Facts label of foods
for infants.
As explained in section II.B.3., we are not proposing any changes
to the mandatory declaration of trans fat in the labeling of foods
intended for the general population. The relationship between the
consumption of trans fat and risk of CHD is well established (Refs. 6
and 49). Cardiovascular disease is also known to begin in childhood
(Refs. 146 and 151). Thus, we tentatively conclude that declaration of
trans fat continues to be necessary to assist consumers in maintaining
health dietary practices, including among infants, young children, and
pregnant and lactating women.
Trans fat declaration is voluntary when the total fat content of a
food is less than 0.5 g (Sec. 101.9(c)(2)(ii)). In addition, if a
manufacturer does not declare the trans fat content because total fat
amount is less than 0.5 g, then the statement ``Not a significant
source of trans fat'' must be placed at the bottom of the table of
nutrient values. This statement indicates why information that is
required to be declared is omitted and provides necessary information
to assist in making healthy dietary choices (55 FR 29487 at 29502). The
statement is also helpful in minimizing space requirements for labels
that do not meet the simplified label format requirements (58 FR 2079
at 2084).
Therefore, we are not proposing any changes to the mandatory
declaration of trans fat on the label of foods represented or purported
to be specifically for infants, children 1 through 3 years of age, or
pregnant and lactating women.
d. Mandatory Declaration of Added Sugars--Whereas FDA regulations
do not provide for the declaration of added sugars on the Nutrition
Facts label, as explained in section II.D.3., we are proposing to
require the mandatory declaration of added sugars on the Nutrition
Facts label. The 2010 DGA provides recommendations for consumption of
added sugars for the U.S. population 2 years of age and older, but not
for infants and children under age two. However, we would not expect
the recommendations for added sugars for a 2 year old to be different
from that of a 1 year old because we do not expect the role of added
sugars in health to be markedly different between children 1 and 2 year
olds. Moreover, the IOM has established DRI ranges for 1 through 3 year
olds because growth velocity is most similar during this age range
(Ref. 15). Further, mandatory declaration of added sugars would be
important for foods for infants 7 through 12 months, as it is for the
general population, to assist consumers in choosing nutrient-dense
foods for infants 7 through 12 months during this phase of accelerated
growth and development. Moreover, we do not have any information that
providing added sugars information on the Nutrition Facts label of
foods marketed to the subpopulations of infants 7 through 12 months and
children 1 to 3 years of age would not assist in maintaining healthy
dietary practices.
Therefore, we are proposing the mandatory declaration of added
sugars on the Nutrition Facts label of foods represented or purported
to be specifically for infants 7 through 12 months, children 1 through
3 years of age, and pregnant and lactating women. We request comment on
our tentative conclusion.
e. Voluntary Declaration of Fluoride--FDA regulations do not
provide for the declaration of fluoride on the Nutrition Facts label of
any foods. For the reasons discussed in section II.G., we are proposing
to permit voluntary declaration of fluoride on the labeling of foods
for the general population based on the factors we consider in section
I.C. and fluoride's role in reducing the risk of dental caries. Because
fluoride provides protection against dental caries by strengthening the
tooth enamel before and after teeth appear (Ref. 90) and because
excessive fluoride intake can cause dental fluorosis in young children
(Ref. 92), we tentatively conclude that the declaration of fluoride on
foods represented or purported to be specifically for children 1
through 3 years of age, and pregnant and lactating women can assist in
maintaining healthy dietary practices. While evidence on dental caries
is lacking for infants 7 through 12 months of age, there is no reason
to expect the role of fluoride in the protection against dental caries
to be different from other age groups. Therefore, proposed Sec.
101.9(c)(5) would permit the voluntary declaration of fluoride on foods

[[Page 11937]]

represented or purported to be specifically for infants 7 through 12
months of age, children 1 through 3 years of age, and pregnant and
lactating women.
4. Declaration of Essential Vitamins and Minerals
The declarations of vitamin A, vitamin C, calcium, and iron are
required on the Nutrition Facts label, and there are no specific
exceptions to this requirement for foods represented or purported to be
specifically for infants and children less than 2 years and children
less than 4 years of age, and pregnant and lactating women. We
considered the factors for mandatory and voluntary declaration of
nutrients discussed in section I.C., as applicable, to determine
whether to propose to require or permit certain vitamins and minerals
in the labeling of foods for infants, children, and pregnant and
lactating women.
The AIs for essential vitamins and minerals (and RDAs for iron and
zinc) for infants 7 to 12 months of age are based on the average intake
of nutrients that infants consumed from breast milk, complementary
foods, and/or supplements with the understanding that these sources
provided sufficient amounts of the nutrients to meet the infant's daily
needs (Refs. 18, 22, and 23). Therefore, the AIs (as well as the RDAs
for iron and zinc) for infants were not based on endpoints related to
chronic disease risk, or a health-related conditions or health-related
physiology. Furthermore, because the AI represents intakes that are
considered adequate and are based on average nutrient intakes from
breast milk, foods, and/or supplements, the presence of an AI indicates
that there is not a public health concern about adequate intake of that
nutrient. Therefore, we could not determine public health significance
for a nutrient during infancy based on an AI for infants. Instead, we
considered the importance of the nutrient in establishing healthy
dietary practices during infancy for later in life, as well as the
relevant available information for children 1 through 3 months of age
that may also be applicable to infants. For nutrients with an RDA for
infants 7 through 12 months of age (i.e., iron and zinc), we considered
the factors for mandatory and voluntary labeling described in section
I.C. to determine whether to propose mandatory or voluntary labeling
for the nutrient.
For the declaration of essential vitamins and minerals for children
1 through 3 years of age and pregnant and lactating women, we propose
the same considerations based on the same rationale as we set forth and
proposed for the general population because scientific and policy
considerations are generally the same and the DGA recommendations apply
to Americans 2 years of age and older. While NHANES data were collected
in lactating women, these data are not included in our analysis in this
document because the sample size of lactating women was small and,
thus, we could not reliably estimate mean intake and status of this
population. However, the conclusions made about nutrient inadequacy
during pregnancy are applied to lactating women since the needs of
essential vitamin and minerals are increased for both pregnant and
lactating women. Therefore, we are proposing the requirements related
to essential vitamins and minerals in the labeling of foods for
pregnant women and those for foods for lactating women should be the
same. Accordingly, we are proposing to remove the provision in Sec.
101.9(c)(8)(i) that requires separate declaration of percent DVs based
on both RDI values for pregnant women and for lactating women in the
labeling of foods represented or purported to be for use by both
pregnant and lactating women.
We did not ask questions related to this issue in the 2007 ANPRM,
but received some comments which we considered in reaching our
tentative conclusions discussed in this document.
a. Mandatory Declaration of Calcium and Iron--We are not proposing
any changes to the mandatory declaration of calcium on foods for the
general population (see section II.H.1.). The AI for calcium for
infants 7 through 12 months of age is based on average calcium
consumption of these nutrients, rather than chronic disease risk,
health related-condition, or physiological endpoints (Ref. 152). For
children 1 through 3 years of age, and pregnant and lactating women,
the RDAs for calcium are based, in part, on bone health (Ref. 22). One
comment to the 2007 ANPRM recommended mandatory declaration of calcium
and iron for labeling of foods for young children.
Our analysis of NHANES 2003-2006 data estimated that infants ages 7
to 12 months have usual calcium intakes above the AI (table 3). Our
analysis of NHANES 2003-2006 estimated that about 12 percent of
children 1 through 3 years of age had usual intakes of calcium below
the EAR, based on intakes from conventional foods only (table 4). The
percentage did not change when supplements were included. We are unable
to consider biomarker data because sensitive biochemical indicators
reflecting calcium nutritional status are lacking. Promoting the
development of eating patterns that are associated with adequate
calcium intake later in life is important (Ref. 153) given that calcium
intakes are inadequate for the majority of the population (see table
1). Intakes of calcium, which is necessary for growth and bone
development, are inadequate among children. Similar to the general
population, approximately 20 percent of pregnant women consumed less
than the EAR for calcium from conventional foods as well as from
conventional foods and supplements (table 5).
Consistent with the factors we consider for essential vitamins and
minerals (see section I.C.), we tentatively conclude that calcium is a
nutrient of public health significance for children 1 through 3 years
of age, and pregnant and lactating women. Because calcium is important
for growth and development, we tentatively conclude that calcium is of
public health significance for infants 7 through 12 months of age. As
such, we agree with the comment that recommended mandatory declaration
of calcium for foods purported to be specifically for young children.
We are not proposing any changes to the mandatory declaration of
iron on foods for the general population (see section II.H.1.).
Although the EAR and RDA are based on daily iron requirements and not
directly on chronic disease risk, iron deficiency is associated with
delayed normal infant motor function (i.e., normal activity and
movement) and mental function (i.e., normal thinking and processing
skills) (Ref. 100). Our analysis of NHANES 2003-2006 data estimated
that about 18 percent of infants ages 7 to 12 months have usual iron
intakes below the EAR, based on intakes from conventional foods only
and 4 percent of infants ages 7 to 12 months have usual iron intakes
below the EAR based on intakes from conventional foods and supplements
(table 3).
For children 1 through 3 years of age, about 1 percent of children
have usual iron intakes below the EAR, based on intakes from
conventional foods only and 0.4 percent of children have usual iron
intakes below the EAR based on intakes from conventional foods and
supplements (table 4). The IOM set the EAR by modeling components of
iron requirements. While total iron intakes appear adequate, the
prevalence of iron deficiency in children ages 1 to 2 years has been
reported to be 14.4 percent and the prevalence of iron deficiency
anemia in children younger than 5 years has been reported to be 14.9
percent (Refs. 74 and 154). Therefore, we agree with the comment that
recommended

[[Page 11938]]

mandatory declaration of iron in the labeling of foods for young
children.
Inadequate iron intakes during pregnancy are also of public health
significance because of the adverse effects for both the mother and the
fetus (such as maternal anemia, premature delivery, low birth weight,
and increased perinatal infant mortality) (Ref. 15). Our analysis of
data collected by NHANES 2003-2006 estimated that 5 percent of pregnant
women 14 to 50 years of age had usual iron intakes below the EAR based
on intakes from conventional foods and 4 percent of pregnant women 14
to 50 years of age had usual iron intakes below the EAR based on
intakes from conventional foods and supplements (table 5). The EAR for
iron for pregnant women was based on estimates of iron stores needed
during the first trimester (Ref. 100). Our analysis of 2003-2006 NHANES
data indicate that among pregnant women aged 12 to 49 years, 25 percent
were iron deficient and 13 percent had iron deficiency anemia. For the
purpose of this analysis, iron deficiency was based on two out of three
cutoffs of iron deficiency variables (transferrin saturation, serum
ferritin, and erythrocyte protoporphyrin) (Ref. 155). While intakes
appear adequate for most individuals, the prevalence of iron deficiency
and iron deficiency anemia indicates that iron deficiency is of public
health significance for pregnant women. As discussed in section
II.H.1., iron is of public health significance for women of
childbearing age. Therefore, we tentatively conclude that iron is a
nutrient of public health significance for lactating women as well.
Because calcium and iron have quantitative intake recommendations
and are considered to have public health significance for infants 7
through 12 months, children 1 through 3 years of age, and pregnant and
lactating women, we tentatively conclude that the declaration of
calcium and iron is necessary to assist consumers in maintaining
healthy dietary practices. Accordingly, proposed Sec. 101.9(c)(8)(ii)
would require the mandatory declaration of calcium and iron on foods
represented or purported to be specifically for infants 7 to 12 months,
children 1 through 3 years of age, or pregnant and lactating women; we
are not providing for any exceptions for these subpopulations from the
requirement for declaration of calcium and iron applicable to foods for
the general population.
b. Mandatory Declaration of Vitamin D and Potassium--We are
proposing to require the declaration of vitamin D on foods for the
general population (see section II.H.1.). The AI for vitamin D for
infants was based on maintenance of serum 25(OH)D concentrations at a
level to achieve and maintain serum 25(OH)D concentrations above a
defined level (30 to 50 nmol/L) in order to meet the needs of the
majority of the infants and support bone accretion (Ref. 22). DRIs (EAR
and RDA) for vitamin D were established at a level to achieve and
maintain serum 25(OH)D concentrations above a defined level (40 to 50
nmol/L) in order to maintain bone health for children 1 through 3 years
of age and pregnant women (Ref. 22).
Serum 25(OH)D data were not available in NHANES 2003-2006 for
infants ages 7 to 12 months. Our analysis of NHANES 2003-2006 dietary
data shows that 28.7 and 33.6 percent of infants ages 7 to 12 months
have usual vitamin D intakes above the AI from conventional foods and
conventional foods plus supplements, respectively (table 3).
Our analysis of NHANES 2003-2006 data shows that about 3 percent of
children 1 through 3 years of age had serum 25(OH)D levels below 40
nmol/L (a level set by IOM as equivalent to EAR, see section II.H.2.a).
Analysis of NHANES 2005-2008 dietary data shows that, assuming minimal
sun exposure, about 82 percent of these children had usual vitamin D
intakes below the EAR from conventional foods only and 66 percent had
usual intakes below the EAR from conventional foods and supplements
(table 4). For pregnant women, 15 percent had serum 25(OH)D levels
below 40 nmol/L, while about 88 percent of pregnant women had usual
vitamin D intakes below the EAR from conventional foods only and 48
percent had usual intakes below the EAR from conventional foods and
supplements (table 5). In addition to data on vitamin D status and
intake, we considered other scientific and policy considerations, such
as the importance of the nutrient in establishing healthy dietary
practices for later life for children 1 through 3 years of age and
pregnant and lactating women. Vitamin D has a role in bone health
through calcium absorption and uptake by bones (Ref. 22). Deficiency
results in inadequate bone mineralization or demineralization of the
skeleton including rickets, osteomalacia, and osteoporosis (Ref. 22).
Therefore, we tentatively conclude that vitamin D has public health
significance in children 1 through 3 years of age and pregnant women
based on the high prevalence of inadequate intakes of vitamin D and its
important role in bone development and health (Ref. 22). In addition,
in 2008, we authorized a health claim for calcium and vitamin D intake
and reduced risk of osteoporosis (Sec. 101.72), signifying vitamin D's
critical role in the risk reduction of this chronic disease for
individuals 2 years of age and older. We also tentatively conclude that
vitamin D is of public health significance for infants 7 through 12
months of age based on its importance for growth and development during
infancy.
We are proposing to require the declaration of potassium on foods
for the general population (see proposed Sec. 101.9(c)(8)(ii) and
section II.H.1.). The AI for infants is based on average potassium
intake from breast milk and/or complementary foods. The AI for the
other life-stage and gender groups is set at a level to maintain blood
pressure, reduce the adverse effects of sodium chloride intake on blood
pressure, and reduce the risk of recurrent kidney stones (Ref. 21).
Our analysis of NHANES 2003-2006 shows that 99 percent of infants
ages 7 to 12 months have usual potassium intakes above the AI (table
3). Only 7 percent of children 1 through 3 years of age (table 4) and 4
percent of pregnant women (table 5) had usual potassium intakes above
the AI from conventional foods or conventional foods plus dietary
supplements, indicating that the adequacy of intakes is very low. In
the absence of a sensitive biochemical indicator of potassium
nutritional status, we could not consider biomarker data to inform the
determination of prevalence of potassium deficiency. In 2000, a FDAMA
notification for a health claim about potassium, blood pressure, and
stroke was submitted to us under section 403(r)(2)(g) of the FD&C Act
(Ref. 114). Foods may bear the following claim ``Diets containing foods
that are good sources of potassium and low in sodium may reduce the
risk of high blood pressure and stroke,'' on the label or labeling of
any food product that meets the eligibility criteria described in the
notification and meets the general requirements for a health claim
(Sec. 101.14(e)(6)). This health claim pertains to the general
population 2 years of age and older. Thus, we recognize the importance
of potassium in the risk reduction of these chronic diseases for
children 2 years of age and older. Therefore, we tentatively conclude
that potassium is of public health significance to children 1 through 3
years of age, and pregnant and lactating women. We have no basis to
conclude that the public health significance of potassium among infants
7 through 12 months of age would be different than the science-based
evidence for children 1 through 3 years of age and consider it
important to

[[Page 11939]]

establish healthy dietary practices for later life. Because of the
benefits of adequate potassium intake in lowering blood pressure, data
indicating low likelihood of potassium adequacy, and importance of
establishing healthy dietary practices for later life, we tentatively
conclude that potassium is a nutrient of public health significance for
infants 7 through 12 months of age, children 1 through 3 years of age,
and pregnant and lactating women.
We are proposing to require the labeling of vitamin D and potassium
on foods represented or purported to be specifically for infants 7
through 12 months of age, children 1 through 3 years of age, or
pregnant and lactating women based on the quantitative intake
recommendations for vitamin D and potassium and the public health
significance of these nutrients. Consequently, we are not providing for
any exceptions for these subpopulations from the general requirement
for declaration of vitamin D and potassium in proposed Sec.
101.9(c)(8)(ii).
c. Voluntary Declaration of Vitamin A and Vitamin C--We are
proposing to no longer require the declaration of vitamin A and vitamin
C on foods for the general population (see section II.H.1.). None of
the DRIs (AIs or RDAs) for vitamin A were based on chronic disease
risk, a health related-condition, or health-related physiological
endpoints. One comment to the 2007 ANPRM stated that intakes of
vitamins A and C among young children appear to be adequate (Ref. 148)
and supported voluntary declaration of these nutrients in the labeling
of foods for this subpopulation.
Our analysis of data from NHANES 2003-2006 shows that less than 2
percent of children had usual vitamin A intakes below the EAR from
conventional foods or conventional foods plus dietary supplements
(table 4). While 36 percent of pregnant women had usual intakes below
the EAR from conventional foods and 22 percent had usual intakes below
the EAR for conventional foods plus dietary supplements, only 1 percent
of these women had serum vitamin A levels that were considered to be
indicative of a vitamin A deficiency (table 5).
While quantitative intake recommendations are available for
vitamins A and C, neither of these vitamins is considered to have
public health significance for children 1 through 3 years of age and
pregnant women. There is a very low prevalence of inadequate intakes of
vitamins A and C or inadequate status among children 1 through 3 years
of age or pregnant women, and we have no evidence to indicate that this
would be different for infants or lactating women. Therefore, we
tentatively conclude that vitamin A and vitamin C are not of public
health significance among infants 7 through 12 months of age, children
1 through 3 years of age, and pregnant and lactating women. Thus, we
agree with a comment that supported voluntary declaration of vitamins A
and C in the labeling of foods for young children. An AI for older
infants was provided by the IOM with the assumption that vitamin A and
vitamin C intakes are adequate during infancy. Accordingly, similar to
our proposal for voluntary declaration of vitamins A and C in the
labeling of foods for the general population, we are proposing to
permit, but not require, the declaration of vitamin A and vitamin C on
foods represented and purported to be specifically for infants 7
through 12 months, children 1 through 3 years of age, or pregnant and
lactating women. As for other voluntary nutrients, the declaration of
these nutrients would be required when these nutrients are added as
nutrient supplements or claims are made about them (proposed Sec.
101.9(c)(8)(ii)).
d. Voluntary Declaration of Other Vitamins and Minerals--As
discussed in section II.H.3., for the general population, we are
proposing to permit the voluntary declaration of vitamin E, vitamin K,
vitamin B6, vitamin B12, thiamin, riboflavin,
niacin, folate, biotin, pantothenic acid, phosphorus, iodine,
magnesium, zinc, selenium, copper, manganese, chromium, molybdenum,
chloride, and choline (proposed Sec. 101.9(c)(8)(ii)). Vitamins and
minerals other than iron, calcium, vitamin D and potassium for infants
either have DRIs that are not based on chronic disease risk, heath-
related conditions, or health-related physiological endpoints or are
not shown to have public health significance due to the prevalence of a
clinically relevant nutrient deficiency. For infants 7 to 12 months,
children 1 through 3 years of age, and pregnant and lactating women, we
tentatively conclude that the essential vitamins and minerals, other
than iron, calcium, vitamin D and potassium, do not have public health
significance and there is no basis for the declaration of these
nutrients to be different from that proposed for the general
population. Accordingly, proposed Sec. 101.9(c)(8)(ii) would allow the
voluntary declaration of vitamin E, vitamin K, vitamin B6,
vitamin B12, thiamin, riboflavin, niacin, folate, biotin,
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, chloride, and choline on foods
represented or purported to be specifically for infants 7 to 12 months,
children 1 through 3 years of age, or pregnant and lactating women,
under the requirements of this section, unless they are added to foods
as a nutrient supplement or if the label or labeling makes a claim
about them, in which case the nutrients would have to be declared.
5. DRVs and RDIs for Infants 7 Through 12 Months of Age
FDA regulations do not include DRVs or RDIs for nutrients for
infants 7 through 12 months of age, except an RDI for protein of 14 g
for infants. We reviewed scientific evidence and recommendations, as
well as comments in response to the 2007 ANPRM to consider establishing
DRVs and RDIs for nutrients for infants 7 through 12 months of age and
to consider revisions to the current RDI for protein.
a. Calories--We have not established a reference calorie intake
level for infants and children less than 2 years of age. For the
general population, a reference calorie intake level is necessary when
using a percent of calories approach to calculating the DRV for
nutrients, such as total fat and carbohydrate. There is no quantitative
intake recommendation for calories for infants and we are not aware of
other scientific data and information on which we could rely to
establish that level. Therefore, we are not proposing to establish a
reference calorie intake level for infants 7 to 12 months.
b. Total Fat--The IOM set an AI of 30 g/d for fat for infants 7
through 12 months of age based on the average intake of human milk and
complementary foods (Ref. 49). There was no AI available in 1993. The
current AI provides a basis on which we can determine an appropriate
DRV for total fat for this subpopulation that can assist consumers in
maintaining healthy dietary practices among this subpopulation.
Therefore, we are proposing to amend Sec. 101.9(c)(9) to include a DRV
of 30 g for fat for infants 7 through 12 months of age.
c. Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber and
Sugars--There are no quantitative intake recommendations from U.S.
consensus reports available for saturated fat, trans fat, cholesterol,
dietary fiber, and sugars for infants. We are not aware of other
scientific data and information on which we could rely to establish
DRVs for these nutrients for infants 7 through 12 months of age.
Accordingly, we are not proposing to establish DRVs for these nutrients
for infants 7 through 12 months of age.

[[Page 11940]]

d. Polyunsaturated Fat, Monounsaturated Fat, Insoluble Fiber,
Soluble Fiber, Insoluble Fiber, Added Sugars, and Sugar Alcohols--
Quantitative intake recommendations from U.S. consensus reports are not
available for polyunsaturated fat, monounsaturated fat, insoluble
fiber, soluble fiber, added sugars, or sugar alcohols for infants. We
are not aware of other scientific data and information on which we
could rely to establish DRVs for these nutrients for this
subpopulation. Accordingly, we are not proposing to establish DRVs for
these nutrients for infants 7 through 12 months of age.
e. Total Carbohydrate--The IOM has set an AI of 95 g/d for
carbohydrates for infants 7 through 12 months of age based on the
average intake of human milk and complementary foods (Ref. 68). There
was no AI available in 1993. The current AI provides a basis on which
we can determine an appropriate DRV for total carbohydrate for this
subpopulation that can assist consumers in maintaining healthy dietary
practices among this subpopulation. Therefore, we are proposing to
amend Sec. 101.9(c)(9) to establish a DRV of 95 g for total
carbohydrate for infants 7 through 12 months of age.
f. Protein--The DV for protein for infants is an RDI, rather than a
DRV. Before 1993, we established the RDIs for protein for all age
groups based on the 1989 RDA. In 1993, we changed the RDI for protein
for the general population to a DRV in response to comments that
suggested the DV for protein should be consistent with the ``percent of
calories'' approach used for the other energy-yielding macronutrients,
total fat and total carbohydrate (58 FR 2206 at 2216). However, we
retained the RDI for infants, and based it on the highest 1968 RDA
value (14 g/d for infants), to be consistent with a population-coverage
approach (58 FR 2206 at 2216).
We find no reason to change the approach of using the RDI for
infants 7 through 12 months. However, we consider it appropriate to
revise the RDI to rely on current quantitative intake recommendations.
In 2002, the IOM established an RDA for infants 7 through 12 months of
1.2 g/kg/d based on nitrogen balance studies and using a reference body
weight of 9 kg (Ref. 84). This reference body weight is also consistent
with current growth charts for infants (Ref. 156). The value 1.2g/kg/
gx9 kg equals 10.8 g/d or a rounded value of 11 g/d. In addition,
protein intakes are well above the current and proposed RDI. Mean
protein intake for infants 6 to 11 months of age was 22 g/d (Ref. 150),
well above the RDA of 11 g/d. Accordingly, we are proposing to revise
Sec. 101.9(c)(9) to establish an RDI of 11 g for protein for infants 7
through 12 months of age.
g. Sodium--For the general population, we are proposing to
establish a DRV for sodium based on the IOM's UL (section II.F.). The
IOM did not set a UL for sodium for infants 7 through 12 months of age
due to insufficient data on adverse effects of chronic overconsumption
in this age group (Ref. 10). We are not aware of other scientific data
and information on which we could rely to establish a DRV for sodium
for this subpopulation. Therefore, we are not proposing a DRV for
sodium for infants 7 through 12 months of age.
h. Fluoride--As discussed in section II.G., although the IOM set an
AI for fluoride, the AIs for infants 7 through 12 months and children 1
through 3 years are close to the EPA benchmarks for total fluoride
intake (Ref. 92). We are not proposing a DRV for fluoride for use in
the labeling of foods for the general population because of a concern
about excess intakes associated with dental fluorosis (section II.G.).
Therefore, we tentatively conclude that a DRV for fluoride is not
warranted for infants 7 through 12 months. The use of such a DRV to
calculate percent DV may have the unintended effect of consumers
selecting foods with higher fluoride amounts, which are not necessary
or advised. Accordingly, we are not proposing to establish a DRV for
fluoride for infants 7 through 12 months of age.
i. Vitamins and Minerals--As noted previously in the introduction
to section II.K., while not included in current regulations, the
preamble to the 1993 DRV/RDI final rule provides a table listing RDIs
for infants (58 FR 2206 at 2213), which is also provided in FDA's Food
Labeling Guide (Ref. 144). We reviewed current quantitative intake
recommendations for vitamins and minerals for infants and considered
comments received in response to the 2007 ANPRM (Ref. 47) to determine
appropriate RDIs for vitamins and minerals to be established in
regulations for infants 7 through 12 months of age.
We consider it important to establish RDIs for infants 7 through 12
months of age because infants in this age range transition from a diet
of mostly breast milk and infant formula to infant cereal and baby
foods (Ref. 147 p. 71) and labeling foods for this subpopulation with
percent DV declarations can assist parents in making nutritious food
choices. The DRIs (AIs and RDAs) provide a basis on which to determine
RDIs for vitamins and minerals for this subpopulation. We consider it
appropriate to use RDAs and, in the absence of RDAs, AIs to determine
appropriate micronutrient RDIs for infants. While there is more
certainty with RDAs than AIs, both RDAs and AIs are sufficient for
setting RDIs, because they both represent intake levels that are
expected to meet or exceed the nutrient needs of the majority of
infants (Ref. 157).
We also considered and rejected an approach, as suggested by a
comment, where the highest reference value available would be used for
each nutrient, irrespective of whether it is an RDI based on the 1968
RDAs, a current RDA, or a current AI. The IOM established DRIs based on
scientific knowledge that update and supersede previous RDA
recommendations. Because DRIs are available for infants 7 through 12
months of age, we are proposing to use these current quantitative
intake recommendations (i.e., AIs and RDAs) for setting RDIs for
infants.
Accordingly, we are proposing to amend Sec. 101.9(c)(8)(iv) to
include a listing of RDIs for vitamin A, vitamin C, vitamin D, vitamin
E, vitamin K, vitamin B12, folate, choline, riboflavin,
niacin, vitamin B6, calcium, iron, thiamin, biotin,
pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, chloride, and potassium for
infants 7 months through 12 months of age.
We invite comment on the adequacy of the proposed RDIs for vitamins
and minerals for older infants.
6. DRVs and RDIs for Children 1 Through 3 Years of Age
FDA regulations do not include DRVs or RDIs for nutrients for
children 1 through 3 years of age, except an RDI for protein of 16 g
for children less than 4 years of age. We reviewed scientific evidence
and current recommendations, as well as comments in response to the
2007 ANPRM to consider establishing DRVs and RDIs for nutrients for
this subpopulation and to consider revisions to the current RDI for
protein.
a. Calories--We have not established a reference calorie intake
level for nutrition labeling for children ages 1 through 3 years.
Several comments to the 2007 ANPRM supported establishing a DV for
calories specifically for young children 1 through 3 years of age.
Citing the IOM and AAP/AHA caloric intake recommendations (Refs. 50 and
71), one comment recommended 1,050 calories as the DV for calories and
supported

[[Page 11941]]

rounding it down to 1,000 calories to facilitate use by consumers.
We consider it appropriate to establish a reference calorie intake
level for children 1 through 3 years of age because, as discussed in
this document, we are proposing to set DRVs using quantitative intake
recommendations that are based on calories (e.g., total fat, saturated
fat, and dietary fiber). Current recommendations from the IOM, AHA,
AAP, and the 2010 DGA for caloric intake range from 800 to 900
calories/d for children 1 year old, approximately 1,000 calories/d for
children 2 years of age, and from 1,000 to 1,200 calories/d for
children 3 years of age (Refs. 6, 50, and 71) . We consider that an
average of the range of these caloric intake recommendations (800 to
1,200 calories/d), i.e., 1,000 calories/d, provides a reasonable
reference calorie intake level. Therefore, we are proposing to amend
Sec. 101.9(c)(9) to provide a reference calorie intake level of 1,000
calories/d for children 1 through 3 years of age.
b. Total Fat--There is no DRV for total fat for children ages 1
through 3 years. One comment to the 2007 ANPRM recommended that 35
percent of the recommended 1,050 calories or 41 g/d of fat be used to
as the DRV for fat because it is the midpoint of the AAP/AHA
recommendation and the IOM Acceptable Macronutrient Distribution Range
(AMDR) for 1 through 3 year olds. We agree that 35 percent of calories
from fat for children 1 through 3 years of age, the midpoint of the IOM
AMDR of 30 to 40 percent, serves as an appropriate basis on which to
set the DRV for total fat. This approach to calculating the DRV for
total fat is consistent with our proposed approach to setting the DRV
for total fat for the general population. Thirty-five percent is also
consistent with AHA and AAP recommendations that 30 to 40 percent of
calories consumed by children 12 through 24 months of age and 30 to 35
percent of calories consumed by children 24 through 48 months of age
should come from fat (Ref. 71). Therefore, we tentatively conclude that
35 percent of total calories from fat (i.e., 39 g using the proposed
reference calorie intake level of 1,000 calories/d) is an appropriate
DRV for total fat for children 1 through 3 years of age. Accordingly,
we are proposing to amend Sec. 101.9(c)(9) to establish a DRV of 39 g
for fat for children 1 through 3 years of age.
c. Saturated Fat, Trans Fat, and Cholesterol--There are no DRVs for
saturated fat, trans fat, or cholesterol for children 1 through 3 years
of age. Once comment to the 2007 ANPRM suggested using the midpoint of
10 to 15 percent of calories for saturated fat, 2 percent of calories
for trans fat based on estimates of mean trans fat intake for the U.S.
population 3 years of age and older, and less than or equal to 300 mg/d
for cholesterol based on the 2005 DGA recommendation.
Cardiovascular disease is known to begin in childhood (Refs. 146
and 151). The 2010 DGA recommends that Americans 2 years of age and
older consume less than 10 percent of calories from saturated fat and
less than 300 mg/d of cholesterol (Ref. 6). Based on these
recommendations, we tentatively conclude that it is appropriate to set
a DRV of 10 g for saturated fat, based on 10 percent of total calories
from saturated fat and using the proposed reference calorie intake
level of 1,000 calories/d which equals 11 g, rounded down to 10 g, and
a DRV of 300 mg for cholesterol for children 1 through 3 years of age.
The comment provided no rationale for using an upper range of 15
percent of calories from saturated fat. We have no information to
indicate that applying the level of 10 percent of calories from
saturated fat to this subpopulation is restrictive, as the comment
asserted. Accordingly, we are proposing to amend Sec. 101.9(c)(9) to
establish a DRV of 10 g for saturated fat and a DRV of 300 mg for
cholesterol for children 1 through 3 years of age.
Current recommendations from the IOM (Ref. 49) and 2010 DGA (Ref.
6) recommend keeping trans fat intake as low as possible but do not
provide any specific appropriate levels of intake. Thus, consistent
with our discussion in section II.B.3., we disagree with the comment
that suggested setting a DRV for trans fat and, therefore, we are not
proposing to establish a DRV for trans fat in response to this comment.
d. Polyunsaturated Fat, Monounsaturated Fat, Sugars, Added Sugars,
Insoluble Fiber, Soluble Fiber, and Sugar Alcohols--There are no DRVs
for polyunsaturated fat, monounsaturated fat, sugars, added sugars,
insoluble fiber, soluble fiber, or sugar alcohol for children 1 through
3 years of age. One comment to the 2007 ANPRM recommended establishing
a DV for n-3 polyunsaturated fatty acids ([alpha]-linolenic acid) of
700 mg/d because [alpha]- linolenic acid is essential to the human diet
and children 1 through 3 years of age are below recommended intake
levels. We disagree that a DRV should be set for n-3 polyunsaturated
fatty acids for children 1 through 3 years of age for the same reasons
that we are not proposing a DRV for these fatty acids for the general
population (see section II.B.). We recognize the essential nature of
[alpha]-linolenic acid in the diet. The IOM based AIs for n-6 linoleic
and n-3 [alpha]-linolenic acid on U.S. median intake levels because of
the lack of linoleic and [alpha]- linolenic acid deficiency in non-
institutionalized populations in the United States (Ref. 49).
For children 1 through 3 years of age, DRIs or other data and
information are not available on which we could rely to establish DRVs
for polyunsaturated fat, monounsaturated fat, sugars, added sugars,
insoluble fiber, soluble fiber, and sugar alcohols. Therefore, we
tentatively conclude that there is no basis for setting DRVs for these
nutrients. Accordingly, we are not proposing DRVs for polyunsaturated
fat, including n-3 or n-6 polyunsaturated fatty acids, monounsaturated
fat, sugars, added sugars, soluble fiber, insoluble fiber, or sugar
alcohols for children 1 through 3 years of age.
e. Total Carbohydrate--There is not a DRV for total carbohydrate
for children 1 through 3 years of age. One comment to the 2007 ANPRM
suggested that we establish a DV for carbohydrates using 59 percent of
calories from carbohydrates, or 154 g using the method of calculation
by difference.
As discussed in section II.D.1., we are proposing a DRV for total
carbohydrate for the general population based on the percentage of
calories in a 2,000 calorie diet remaining after the sum of the DRV for
fat (30 percent) plus the DRV for protein (10 percent) have been
subtracted. We also consider this method to be appropriate for setting
a DRV for total carbohydrate for children 1 through 3 years of age.
Total calories (100 percent) minus the proposed DRV for total fat (35
percent of calories) and the proposed DRV for protein (5 percent of
calories) equals 60 percent of calories from total carbohydrate. A
value of 60 percent of total calories from total carbohydrates also
falls within the IOM AMDR recommendation of 45 to 65 percent of
calories from carbohydrates for children 1 through 3 years of age.
Therefore, we tentatively conclude that an appropriate DRV for total
carbohydrate is 60 percent of calories (i.e., 150 g using the proposed
reference calorie intake level of 1,000 calories/d). Accordingly, we
are proposing to amend Sec. 101.9(c)(9) to set a DRV of 150 g for
total carbohydrate for children 1 through 3 years of age.
f. Dietary Fiber--There is not a DRV for dietary fiber for children
1 through 3 years of age. One comment to the 2007 ANPRM recommended
using 15 g/d as the basis of the DRV for dietary fiber, based on the AI
of 14 g/1,000 calories and a 1,050 calorie diet. We agree that the AI
of 14 g/1,000 calories for dietary fiber for children 1 through 3 years
of

[[Page 11942]]

age (Ref. 66) should be used to set a DRV for dietary fiber to be
consistent with how other proposed DRVs are being set. Given that we
are proposing a reference calorie intake level of 1,000 calories/d for
this subpopulation, we are proposing to amend Sec. 101.9(c)(9) to
establish a DRV of 14 g for dietary fiber for children 1 through 3
years of age.
g. Protein--The RDI for protein for children less than 4 years of
age was based on the 1989 RDA for protein of 16 g/d (Sec.
101.9(c)(7)(iii)). One comment to the 2007 ANPRM recommended
maintaining the DV of 16 g for protein because the RDA for protein of
13 g/d for toddlers 1 through 3 years of age appears low relative to
the amount of protein from a diet pattern consistent with dietary
guidance from AAP/AHA.
We consider it appropriate to determine whether changes are
necessary to the current RDI taking into account current
recommendations and protein intakes. Protein intakes are well above the
current RDI. Mean protein intake for children 12 to 23 months of age
was 44 g/d (Ref. 150), well above the RDA of 13 g/d and the midpoint of
the AMDR of 5 to 20 percent calories from protein (i.e., 12.5 percent
of calories from protein or 31 g/d) (Ref. 84). The protein AMDR for
children 1 through 3 years of age is 5 to 20 percent of calories and
the RDA is approximately 5 percent of calories (Ref. 84). While the RDA
is lower than the amount of protein consistent with guidance from AAP/
AHA, we explain in section II.B.2.c. that we do not consider the menu
modeling approach used to develop this guidance appropriate to
determine DRVs because it does not permit the selection of DRVs that
are based on scientific evidence related to actual public health
outcomes. In light of the proposed reference calorie intake level and
the approaches used for the proposed DRVs for fat and carbohydrate that
are based on percent of calories, we tentatively conclude that, as with
the general population, the DV for protein for children 1 through 3
years of age should be a DRV, rather than an RDI (using the RDA).
Therefore, we tentatively conclude that a DRV for protein should be
based on 5 percent of 1,000 calories or 50 calories which equals 12.5 g
or, when rounded up, is 13 g. Accordingly, we are proposing to amend
Sec. 101.9(c)(7)(iii) to establish a DRV for protein of 13 g for
children 1 through 3 years of age.
h. Sodium--For the general population, we are proposing to
establish a DRV based on the UL for sodium (section II.F.). There is no
DRV for sodium for children 1 through 3 years of age. Two comments to
the 2007 ANPRM recommended basing the DRV for sodium on the IOM's UL of
1,500 mg/d for children 1 through 3 years of age to be consistent with
recommendations from AAP and AHA (Ref. 71).
The IOM derived the UL for children 1 through 3 years of age by
extrapolation from the adult UL of 2,300 mg/d based on observational
studies showing that blood pressure increases with age into adulthood
and the recognition that risk factors for CVD, such as high blood
pressure and atherosclerosis, occur in childhood (Ref. 10). We agree
with the comments noting that 1,500 mg is an appropriate DRV for sodium
for children 1 through 3 years of age. Consistent with the proposed
approach for the general population, we are proposing to amend Sec.
101.9(c)(8)(iv) to establish a DRV of 1,500 mg for sodium for children
1 through 3 years of age.
i. Fluoride--There is not a DV for fluoride for children 1 through
3 years of age. One comment to the 2007 ANPRM suggested that fluoride
should not have a DV because it is not found abundantly in food. We
disagree with this comment. Whether a nutrient is found abundantly in
food is not a consideration for FDA in setting DVs. The IOM recognized
fluoride as a trace mineral that is important for public health by
setting an AI based on evidence of its role in reducing the risk of
dental caries.
However, we tentatively conclude that a DRV should not be
established for fluoride. Although the IOM set an AI for fluoride, the
AI for children 1 through 3 years of age is close to the EPA benchmarks
for maximum total fluoride intake (Ref. 92). In addition, we are not
proposing a DRV for the general population because of concern about
excess intakes associated with dental fluorosis (see section II.G.).
The use of such a DRV to calculate percent DV may have the untoward
effect of consumers selecting foods with higher fluoride amounts, which
are not necessary or advised. Therefore, we tentatively conclude that a
DRV for fluoride is not warranted for children 1 through 3 years of
age. Accordingly, we are not proposing a DRV for fluoride for children
1 through 3 years of age.
j. Vitamins and Minerals--As explained earlier, while not included
in our regulations, the preamble to the 1993 DRV/RDI final rule
provides a table listing RDIs for children less than 4 years of age (58
FR 2206 at 2213), which is also provided in FDA's Food Labeling Guide
(Ref. 144). We reviewed current quantitative intake recommendations for
vitamins and minerals for infants and considered comments received in
response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for
vitamins and minerals for children 1 through 3 years of age.
The IOM's quantitative intake recommendations (AIs and RDAs)
provide a basis on which to determine RDIs for vitamins and minerals
for this subpopulation. In addition, where data on functional
indicators of nutritional status were available, the IOM relied on such
data and determined that available evidence was sufficient to establish
appropriate RDAs and AIs for vitamins and minerals for this
subpopulation. Therefore, we disagree with a comment to the 2007 ANPRM
that suggested that more population-specific data based on functional
indicators of nutritional status are needed before establishing the
RDIs for vitamins and minerals.
We consider it appropriate to use RDAs and, in the absence of RDAs,
AIs to determine appropriate micronutrient RDIs for children 1 through
3 years of age. As such, we agree with comments that suggested using
RDAs to determine the RDIs for selenium and vitamin E and AIs to
determine the RDIs for choline, vitamin K, and manganese, which do not
have established RDAs. The RDA, when available, is the best estimate of
an intake level that will meet the nutrient goals of practically all
consumers who would use the Nutrition Facts label. AIs have less
certainty than RDAs, but they represent goals for nutrient intake for
individuals and provide the best estimate based on current science for
use in setting RDIs for such nutrients.
Finally, we disagree with comments suggesting we use 1,800 or 2,000
mg/d potassium as the basis for the RDI for potassium because it is
inconsistent with the proposed approach for the general population. The
comments did not explain why data collection on mean potassium intake
should be the basis for the DV in lieu of the AIs and RDAs. In
addition, promoting the development of eating patterns that will be
associated with adequate potassium intake later in life is important
because chronic conditions such as elevated blood pressure, bone
demineralization, and kidney stones likely result from inadequate
potassium intakes over an extended period of time, including childhood
(Ref. 136). The AI for potassium is 3,000 mg/d and we consider it an
appropriate basis for establishing a RDI for potassium for children 1
through 3 years of age.
Therefore, using the RDAs and AIs, we are proposing to amend Sec.
101.9(c)(8)(iv) to establish RDIs as set forth previously for vitamin
A, vitamin

[[Page 11943]]

C, vitamin D, vitamin E, vitamin K, vitamin B12, folate,
choline, riboflavin, niacin, vitamin B6, calcium, iron,
thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium,
zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and
potassium for children 1 through 3 years of age.
We invite comment on the adequacy of the proposed RDIs for vitamins
and minerals for children 1 through 3 years of age.
7. DRVs and RDIs for Pregnant and Lactating Women
a. Calories--The reference calorie intake of 2,000 used for the
general population applies to pregnant and lactating women (Sec.
101.9(c)(9)). The calorie needs for pregnant and lactating women are
similar to the general population and few products are purported for
pregnant and lactating women. Therefore, we tentatively conclude that
it is appropriate to establish a reference calorie intake level for
setting DRVs for pregnant and lactating women that is the same as for
the general population. Accordingly, we are proposing to use the 2,000
reference calorie intake level for setting DRVs for pregnant and
lactating women (Sec. 101.9(c)(9)).
b. Total Fat, Saturated Fat, Cholesterol, Total Carbohydrate,
Sodium, and Dietary Fiber--FDA regulations do not provide DRVs for
total fat, saturated fat, cholesterol, total carbohydrate, sodium, and
dietary fiber for pregnant and lactating women. Quantitative intake
recommendations for total fat, saturated fat, cholesterol, total
carbohydrate, sodium, and dietary fiber for pregnant and lactating
women are generally similar to the general population (Refs. 6 and 23).
Therefore, we tentatively conclude that the DRVs for total fat,
saturated fat, cholesterol, total carbohydrate, sodium, and dietary
fiber for pregnant and lactating women should remain the same as for
the general population. Accordingly, we are proposing to amend Sec.
101.9(c)(9) to establish DRVs for pregnant and lactating women using
the proposed DRVs for the general population for total fat, saturated
fat, cholesterol, total carbohydrate, sodium, and dietary fiber.
c. Trans Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble
Fiber, Insoluble Fiber, Sugars, Added Sugars, and Sugar Alcohols--There
are no DRVs for trans fat, polyunsaturated fat, monounsaturated fat,
soluble fiber, insoluble fiber, sugars, added sugars, or sugar alcohol
for pregnant and lactating women. As discussed in sections II.B. and
II.D., we are not proposing DRVs for these nutrients for the general
population because of a lack of quantitative intake recommendations.
Similarly, quantitative intake recommendations are lacking for these
nutrients for pregnant and lactating women. Therefore, we are not
proposing to establish DRVs for trans fat, polyunsaturated and
monounsaturated fat, soluble fiber, insoluble fiber, sugars, added
sugars, or sugar alcohols for pregnant and lactating women.
d. Protein--FDA established RDIs of 60 g protein for pregnant women
and 65 g protein for lactating women (Sec. 101.9(c)(7)(iii)) based on
the highest 1989 RDAs for pregnant and lactating women (58 FR 2206 at
2216). The IOM established 71 g/d protein as the RDA for pregnant and
lactating women based on the needs for maternal and fetal development
and human milk production. Because the RDA for protein during both
pregnancy and lactation is the same (Ref. 84) and given that most foods
represented or purported to be specifically for pregnant women are also
represented or purported to be specifically for lactating women, we
tentatively conclude that it is appropriate to establish a single RDI
of 71 g applicable to both pregnant and lactating women. We tentatively
conclude that the DV for protein for pregnant and lactating women
should remain an RDI (using the RDA) instead of a DRV because the DRV
approach used to calculate protein for the general population based on
10 percent of 2,000 calories, which equals 50 g of protein/d, falls
short of the recommended protein needs of pregnant and lactating women
of 71 g/d. Therefore, we are proposing to amend Sec. 101.9(c)(7)(iii)
to establish an RDI of 71 g for protein for pregnant and lactating
women.
e. Fluoride--There is no DRV for fluoride for the general
population or for pregnant and lactating women. While an AI has been
established for fluoride, we are not proposing to establish a DRV for
fluoride for the general population for the reasons discussed in
section II.G. Similarly, because the AI for fluoride for pregnant and
lactating women is not different from the general population (Ref. 90),
we are not proposing a DRV for fluoride for pregnant and lactating
women.
f. Vitamins and Minerals--While not included in FDA regulations,
the preamble to the 1993 DRV/RDI final rule provides a table listing
RDIs for pregnant and lactating women (58 FR 2206 at 2213), which is
also provided in FDA's food labeling guide (Ref. 144). We reviewed
current quantitative intake recommendations for vitamins and minerals
for pregnant and lactating women and considered comments received in
response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for
vitamins and minerals for pregnant and lactating women.
For the same reasons stated for the general population (see section
II.I.), we consider it appropriate to establish RDIs for pregnant and
lactating women for vitamins and minerals that have DRIs, using
population-coverage RDAs and AIs, instead of population-weighted EARs.
In addition, we are proposing to establish a single set of RDIs
intended for both pregnant women and lactating women because nutrient
needs during pregnancy and lactation are similar (Refs. 16, 17, 21, 22,
140). Moreover, most foods represented or purported to be specifically
for pregnant women are, at the same time, represented or purported to
be specifically for lactating women and, as such, using one set of RDIs
would address practical concerns related to limited space on food
labels.
Therefore, we are proposing to amend Sec. 101.9(c)(8)(iv) to
establish RDIs as set forth previously for vitamin A, vitamin C,
vitamin D, vitamin E, vitamin K, vitamin B12, folate,
choline, riboflavin, niacin, vitamin B6, calcium, iron,
thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium,
zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and
potassium for pregnant and lactating women.

[[Page 11944]]

Table 3--Prevalence of Nutrient Inadequacy and Adequacy (From Conventional Foods and Water) and From Total
Intake (Conventional Foods, Water, and Supplements) of U.S. Infants 7 Through 12 Months of Age \1\
----------------------------------------------------------------------------------------------------------------
Usual nutrient intake \2\
---------------------------
Nutrients EAR \3\ % Below the EAR \4\
---------------------------
Food Total intake
----------------------------------------------------------------------------------------------------------------
Iron............................................ 6.9 mg............................ 17.8 3.7
Zinc............................................ 2.5 mg............................ 0.1 0.1
---------------------------
AI \3\............................ % Above AI \5\
---------------------------
Choline......................................... 150 mg............................ 23.5 23.5
Folate.......................................... 80 mcg............................ 100 100
Niacin.......................................... 4 mg.............................. 99.9 99.9
Riboflavin...................................... 0.4 mg............................ 100 100
Thiamin......................................... 0.3 mg............................ 99.9 99.9
Vitamin A....................................... 500 mcg........................... 86.9 87.5
Vitamin B6...................................... 0.3 mg............................ 99.9 99.9
Vitamin B12..................................... 0.5 mg............................ 99.8 99.8
Vitamin C....................................... 50 mg............................. 90.1 94
Vitamin D....................................... 10 mcg............................ 28.7 33.6
Vitamin E....................................... 5 mcg............................. 67 70.6
Vitamin K....................................... 2.5 mcg........................... 100 100
Calcium......................................... 260 mg............................ 99.6 99.6
Copper.......................................... 220 mcg........................... 100 100
Magnesium....................................... 75 mg............................. 97.6 97.6
Phosphorus...................................... 275 mg............................ 98.9 98.9
Potassium....................................... 700 mg............................ 98.8 98.8
Selenium \6\.................................... 20 mcg............................ 9.9 9.9
----------------------------------------------------------------------------------------------------------------
\1\ All prevalence of nutrient inadequacy or adequacy and status biomarker data is based on NHANES 2003-2006
except for vitamin D and choline (NHANES 05-08).
\2\ Usual nutrient intake distributions from conventional foods are determined using the National Cancer
Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48).
\3\ The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for infants ages 7-12 months are
established by the Institute of Medicine https://www.iom.edu/Activities/Nutrition/SummaryDRIs/~/media/Files/
Activity%20Files/Nutrition/DRIs/New%20Material/2--%20RDA%20and%20AI%20Values--Vitamin%20and%20Elements.pdf.
\4\ The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence
of nutrient inadequacy for iron and zinc. For iron, refer to Table I-5 Probability of inadequate iron intakes
(Refs. 100 and 158).
\5\ For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at
or above the AI.
\6\ We did not receive any comments for this nutrient (for which voluntary declaration is permitted) in response
to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database for
chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these nutrients
are not listed in this table.

Table 4--Prevalence of Nutrient Inadequacy and Adequacy (From Conventional Foods and Water and Total Intake
(Conventional Foods, Water, and Supplement) and Status Biomarkers of the U.S. Population of Children 1 Through 3
Years of Age \1\
----------------------------------------------------------------------------------------------------------------
Usual nutrient intake \2\
--------------------------------------------------------------------------------
% below EAR \4\ Status biomarker
Nutrient ------------------------------------------------------------
EAR \3\ Total % Below
Food intake Biomarker cutoff cutoff
----------------------------------------------------------------------------------------------------------------
Folate......................... 120 mcg........... 0.1 0.1 Serum folate < 2 ng/mL 0.01
RBC folate < 95 ng/mL. 0.17
Niacin......................... 5 mg.............. 0.6 0.6 N/A.................... N/A
Riboflavin..................... 0.4 mg............ 0 0 N/A.................... N/A
Thiamin........................ 0.4 mg............ 0 0 N/A.................... N/A
Vitamin A...................... 210 mcg........... 1.9 1.5 N/A.................... N/A
Vitamin B6..................... 0.4 mg............ 1.5 1.1 Serum B6 (pyridoxal 5' 2.57
phosphate) < 20 nmol/L.
Vitamin B12.................... 0.7 mcg........... 0 0 Serum B12 < 200 pg/mL.. 0.2
Vitamin C...................... 13 mg............. 1.9 1.3 N/A.................... N/A
Vitamin D...................... 10 mcg............ 82.0 66.5 Serum 25(OH)D.......... 8.2
2.9
< 50 nmol/L............ 0.8
< 40 nmol/L............
< 30 nmol/L............
Vitamin E...................... 5 mg.............. 84.6 61.6 Serum E < 516 mcg/dL... 1.3
Calcium........................ 500 mg............ 11.7 11.7 N/A.................... N/A
Copper......................... 260 mcg........... 0.2 0.2 N/A.................... N/A
Iron........................... 3 mg.............. 1.0 0.42 Serum ferritin < 12 mcg/ 17.7
L (99-02) \5\.
Iron deficiency 7.9
(Ferritin model, 99-
02).

[[Page 11945]]

Anemia (99-02)......... 1.8
Serum ferritin < 12 mcg/ 23.3
L (03-06).
Iron deficiency (Body 9.5
iron model, 03-06).
Magnesium...................... 65 mg............. 0 0 N/A.................... N/A
Phosphorus..................... 380 mg............ 0.2 0.2 N/A.................... N/A
Selenium \6\................... 17 mcg............ 0 0 N/A.................... N/A
Zinc........................... 2.5 mg............ 1.4 1.2 N/A.................... N/A
------------------------
AI \3\............ % Above AI \7\
------------------------
Choline........................ 200 mg............ 46.4 48.5 N/A.................... N/A
Potassium...................... 3000 mg........... 6.5 6.5 N/A.................... N/A
Vitamin K...................... 30 mcg............ 50.9 51.2 N/A.................... N/A
----------------------------------------------------------------------------------------------------------------
N/A = Data is not available in NHANES; mg = milligrams; mcg = micrograms.
\1\ All prevalence of nutrient adequacy or inadequacy and status biomarker data is based on NHANES 2003-2006
except for vitamin D and choline intakes (2005-2008); serum pyridoxal-5'-phosphate (2005-2006); serum
tocopherol for age 3 years (1999-2002), and serum ferritin (1999-2002).
\2\ Usual nutrient intake distributions from conventional foods are determined using the National Cancer
Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48).
\3\ The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for children 1-3 years of age
are established by the Institute of Medicine. Units are in mg/d or mcg/d https://www.iom.edu/Activities/
Nutrition/SummaryDRIs/~/media/Files/Activity%20Files/Nutrition/DRIs/New%20Material/2--
%20RDA%20and%20AI%20Values--Vitamin%20and%20Elements.pdf.
\4\ The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence
of nutrient inadequacy. For iron, refer to Table I-5 Probability of inadequate iron intakes (Ref. 100).
\5\ Serum ferritin analysis changed from the Biorad assay to the Roche assay in 2003. Serum ferritin for 2003-
2006 using the Biorad assay was adjusted to be comparable to those 2004-2006 data using the Roche assay. Iron
deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables
(transferrin saturation, serum ferritin, and erythrocyte protoporphyrin, NHANES 1999-2002) (Refs. 155 and
159). Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. Iron
deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to ferritin
using NHANES 2003-2006 data. NHANES 1999-2002 did not measure transferrin receptor; therefore body iron model
could not be analyzed for this time frame. NHANES 2003-2006 did not measure all iron biomarkers for all ages,
thus serum ferritin, body iron model or ferritin model could not be analyzed for all ages during this time
period.
\6\ We did not receive any comments for this nutrient (for which voluntary declaration is permitted) in response
to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database for
chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these nutrients
are not listed in this table.
\7\ For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at
or above the AI.

Table 5--Prevalence of Nutrient Inadequacy and Adequacy (From Conventional Foods and Water) and Total Intake
(Conventional Foods, Water, and Supplement) and Status Biomarkers of the U.S. Population of Pregnant Women 14-50
Years of Age \1\
----------------------------------------------------------------------------------------------------------------
Usual nutrient intake \2\
----------------------------------------------------------
% below EAR \4\ Status biomarker
Nutrient Weighted EAR \3\ ----------------------------------------------------------
Total % below
Food intake Biomarker cutoff cutoff
----------------------------------------------------------------------------------------------------------------
Folate.......................... 520 mcg............ 39.6 27.5 Serum folate < 2 ng/mL.. 0.28
RBC folate < 95 ng/mL... 0
Niacin.......................... 14 mg.............. 3.7 2.6 N/A..................... N/A
Riboflavin...................... 1.2 mg............. 3.6 3.1 N/A..................... N/A
Thiamin......................... 1.2 mg............. 10.4 6.1 N/A..................... N/A
Vitamin A....................... 549 mcg............ 36.4 22 Serum A < 20 mcg/mL..... 1.0
Vitamin B6...................... 1.6 mg............. 28.3 15.7 Serum B6 (Pyridoxal 5' 0
phosphate) < 20 nmol/L.
Vitamin B12..................... 2.2 mcg............ 1.6 1.1 Serum B12 < 200 pg/mL... 4.1
Vitamin C....................... 70 mg.............. 21.7 11.2 Serum C < 11.4 0.4
[micro]mol/L.
Vitamin D....................... 10 mcg............. 87.6 47.6 Serum 25(OH)D
< 50 nmol/L............. 16.9
< 40 nmol/L............. 6.4
< 30 nmol/L............. 3.7
Vitamin E....................... 12 mg.............. 94.8 51 Serum E < 516 mcg/dL.... 0.6
Calcium......................... 835 mg............. 20.7 18.9 N/A..................... N/A
Copper.......................... 0.79 mcg........... 4.4 4.1 N/A..................... N/A
Iron............................ 22 mg.............. 5.3 3.71 Serum ferritin < 15 mcg/ 26.1
L.
\5\ Iron deficiency
--Body iron model.... 16.4
--Ferritin model 25.1
Anemia.

[[Page 11946]]

12.8
Magnesium....................... 295 mg............. 57.2 55.0 N/A..................... N/A
Phosphorus...................... 583 mg............. 0.3 0.3 N/A..................... N/A
Selenium \6\.................... 49 mcg............. 0.7 0.7 N/A..................... N/A
Zinc............................ 9.5 mg............. 15.9 12.8 N/A..................... N/A
-------------------------------------------
Weighted AI \3\ % Above AI \7\
-------------------------------------------
Choline......................... 450 mg............. 13.5 13.6 N/A..................... N/A
Potassium....................... 4700 mg............ 3.9 3.9 N/A..................... N/A
Vitamin K \6\................... 89 mcg............. 34.5 36.1 N/A..................... N/A
----------------------------------------------------------------------------------------------------------------
N/A = Data is not available in NHANES; mg = milligrams; mcg = micrograms.
\1\ All prevalence of nutrient adequacy or inadequacy and biomarker data is based on NHANES 2003-2006 except for
vitamin D and choline intakes (2005-2008); serum pyridoxal-5'-phosphate (2005-2006); serum tocopherol (1999-
2002), and serum ferritin (1999-2002). Biomarker data are for pregnant women 12 through 49 years of age.
\2\ Usual nutrient intake distributions from conventional foods are determined using the National Cancer
Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48).
\3\ The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for pregnant women 14-50 years
of age are established by the Institute of Medicine. Units are in mg/d or mcg/d https://www.iom.edu/Activities/
Nutrition/SummaryDRIs/~/media/Files/Activity%20Files/Nutrition/DRIs/New%20Material/2--
%20RDA%20and%20AI%20Values--Vitamin%20and%20Elements.pdf.
\4\ The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence
of nutrient inadequacy. For iron, refer to Table I-5 Probability of inadequate iron intakes (Ref. 100).
\5\ Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to
ferritin using NHANES 2003-2006 data. Iron deficiency based on the ferritin model is calculated using 2 out of
3 cutoffs of iron deficiency variables (transferrin saturation, serum ferritin, and erythrocyte
protoporphyrin, NHANES 1999-2002) (Refs. 155 and 159). Anemia was based upon iron deficiency criteria
(ferritin model) and a low hemoglobin level.
\6\ We did not receive any comments for these nutrients (for which voluntary declaration is permitted) in
response to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database
for chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these
nutrients are not listed in this table.
\7\ For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at
or above the AI.

L. Dietary Supplements

FDA regulations specific to dietary supplement nutrition labeling
appear in Sec. 101.36. Many requirements in Sec. 101.36 are
consistent with the requirements for the nutrition labeling of
conventional foods in Sec. 101.9 and there are references throughout
Sec. 101.36 to requirements established in Sec. 101.9. As discussed
previously, we are proposing several amendments to Sec. 101.9 that, if
finalized, would result in significant changes to the content and
format of the Nutrition Facts label. For consistency, we are proposing
to amend Sec. 101.36 so that the content and format of the Supplement
Facts label corresponds with that of the Nutrition Facts label. The IOM
Labeling Report included a recommendation that the Supplement Facts
label should use the same DVs as the Nutrition Facts label. In light of
the IOM recommendation, we requested comment in the 2007 ANPRM on
whether the Supplement Facts label should use the same DVs as the
Nutrition Facts label, as suggested in the IOM labeling report. We
received no comments in response to this question. We also did not
receive any other comments to the 2007 ANPRM that are relevant to the
Supplement Facts label.
We expect that the proposed DVs for infants 6 through 12 months,
children 1 through 3 years, pregnant and lactating women, and
individuals 4 years of age and older may result in reformulation of
dietary supplement products. Reformulations could impact intakes of
vitamins and minerals for all age groups. We invite comment, including
the submission of data and other factual information, on the
reformulation of dietary supplement products that may result from
proposed changes to the DVs, as well as information on the potential
consequences of such reformulations.
Our proposed changes to the Supplement Facts label in light of
proposed changes to the Nutrition Facts label are described in this
document.
1. Mandatory Dietary Ingredients
In Sec. 101.36(b)(2), we established a list of dietary ingredients
that have an RDI or a DRV as established in Sec. 101.9(c)(8)(ii) that
are referred to as the ``(b)(2)-dietary ingredients.'' These 15
nutrients must be listed in the Supplements Facts label for a dietary
supplement when they are present in amounts that exceed the amount that
can be declared as zero in the nutrition labeling of foods in
accordance with Sec. 101.9(c).
Section Sec. 101.9(c)(8)(ii) requires vitamin A, vitamin C,
calcium, and iron to be declared on food labels. As discussed in
section II.H., we are proposing to amend Sec. 101.9(c)(8)(ii) to allow
for voluntary declaration of vitamins A and C and to require mandatory
declaration of calcium, vitamin D, potassium, and iron. In addition, we
are proposing to eliminate the mandatory declaration of ``Calories from
fat'' on the Nutrition Facts label (see section II.A.1.).
We are proposing to update the list of (b)(2)-dietary ingredients
to maintain consistency with the proposed requirements for nutrition
labeling of foods in Sec. 101.9. Therefore, proposed Sec.
101.36(b)(2)(i) would: (1) No longer require declaration of vitamin A,
vitamin C, or Calories from fat; (2) require vitamin D and potassium;
(3) require the declaration of added sugars; and (4) retain the other
(b)(2)-dietary ingredients as mandatory declarations. We are also
proposing to amend

[[Page 11947]]

Sec. 101.36(b)(2)(i), (b)(2)(i)(B)(1), and (b)(2)(iii)(G) to remove
the requirement for declaration of ``Calories from fat.''
2. Folate and Folic Acid
We are proposing to only allow the use of the term ``folic acid''
for the labeling of dietary supplements. Folate is a nutrient found in
conventional foods, whereas folic acid is the synthetic form of folate
that is added to fortified conventional foods and dietary supplements.
As discussed in section II.J.2., ``folic acid'' or ``folacin'' are
identified as synonyms of folate and can be used on the Nutrition Facts
label (Sec. 101.9(c)(8)(v)) or in the Supplement Facts label (Sec.
101.36(b)(2)(i)(B)(2)). However, because of the difference in
bioavailability between naturally occurring folate, and synthetic folic
acid, we are proposing to amend Sec. 101.9(c)(8)(v) such that the term
``folate'' would be used in the labeling of conventional foods that
contain either folate alone or a mixture of folate and folic acid. As
discussed in section II.J.2.c., we consider only the term ``folic
acid'' to be appropriate for use in the labeling of dietary
supplements. Therefore, we are proposing to amend Sec. Sec.
101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to specify that ``folic acid''
is the term used to declare folic acid content of dietary supplements;
and to remove ``folate'' and ``folacin'' from the list of synonyms that
may be used to declare folic acid on the Supplement Facts label.
3. Units of Measure
In section II.J.3., we are proposing to amend Sec. 101.9(c)(8)(iv)
to replace ``IU'' for the RDIs for vitamin A, vitamin D, and vitamin E
with mcg RAE for vitamin A, mcg for vitamin D, and mg [alpha]-
tocopherol for vitamin E. In addition, in section II.J.2., we are
proposing to quantify and declare folate and folic acid in ``mcg DFE''
instead of ``mcg.'' In the interest of maintaining consistency in
nutrition labeling of foods and dietary supplements, we are proposing
to amend Sec. 101.36(b)(2)(i)(B)(3) to require that when [beta]-
carotene is included in parentheses following the percent statement for
vitamin A, it should be declared using ``mcg'' (representing mcg RAE)
as the unit of measure. In addition, under Sec. 101.36(b)(2)(ii)(B),
the proposed units of measure for vitamin D, vitamin E, and folate in
Sec. 101.9(c)(8)(iv) would be used in the declaration of vitamin D,
vitamin E, and folic acid in the Supplement Facts label.
In 2005, we received a citizen petition (Docket No. FDA-2005-P-0126
(formerly Docket No. 2005P-0293)) requesting us to preclude the
declaration of [beta]-carotene in supplements as vitamin A (https://www.regulations.gov/# !docketDetail;D=FDA-2005-P-0126). The petition
maintained that the declaration of vitamin A on dietary supplement
labels is misleading when the supplement contains mostly [beta]-
carotene because only a small amount of [beta]-carotene is converted by
the liver into vitamin A. We do not see a need to preclude the
declaration of [beta]-carotene as vitamin A, because the difference in
the bioconversion of [beta]-carotene to vitamin A will be accounted for
with the proposed declaration of vitamin A content as ``mcg''
(representing mcg RAE) (see section II.J.3.). Therefore, we are not
proposing to preclude the declaration of [beta]-carotene in dietary
supplements as vitamin A.
4. Order of Nutrients Declared on the Label
For dietary supplements, Sec. 101.36(b)(2)(i)(B) specifies that
vitamins and minerals must be declared in a specific order on the
Supplement Facts label. We are now proposing to establish an RDI for
choline in section I.7. Therefore, it is necessary to add choline to
the list of ordered nutrients in Sec. 101.36(b)(2)(i)(B). We are
proposing to require that, when declared, choline shall follow
potassium on the label.
5. Subpopulations
We discussed several changes in section II.K. that will affect
dietary supplement labeling currently required for infants, children
under 4 years of age, and pregnant and lactating women. To maintain
consistency with the proposed requirements for nutrition labeling of
foods in Sec. 101.9, we tentatively conclude that it is appropriate to
revise the appropriate sections of Sec. 101.36 that pertain to
labeling requirements for foods, other than infant formula, that are
represented or purported to be specifically for infants 7 through 12
months, children 1 through 3 years, and pregnant and lactating women.
Therefore, we are proposing to amend Sec. 101.36(b)(2)(iii) to read as
follows: ``The percent of the Daily Value of all dietary ingredients
declared under paragraph (b)(2)(i) of this section shall be listed,
except that the percent DV for protein may be omitted as provided in
Sec. 101.9(c)(7); no percent DV shall be given for subcomponents for
which DRVs have not been established (e.g., sugars).''
When the percent DV is declared for total fat, saturated fat, total
carbohydrate, dietary fiber, or protein, we require that a symbol be
placed next to the percent DV declaration for these nutrients that
refers the consumer to a statement at the bottom of the label that says
``Percent Daily Values are based on a 2,000 calorie diet.'' This
statement is only accurate for products meant for children and adults
that are 4 years of age and older. The proposed DRVs for total fat,
total carbohydrate, dietary fiber, and protein for children 1 through 3
years of age are based on a 1,000 calorie diet. Therefore, when a
product that is represented or purported to be for children 1 through 3
years of age contains a percent DV declaration for total fat, total
carbohydrate, dietary fiber, or protein, we are proposing to require in
Sec. 101.36(b)(2)(iii)(D) that a symbol be placed next to the percent
DV declaration that refers the consumer to a statement at the bottom of
the label that says ``Percent Daily Values are based on a 1,000 calorie
diet.''
In addition, we are proposing to amend Sec. 101.36(b)(2)(iii)(E)
to change the categories of infants and children less than 4 years of
age to infants 7 through 12 months of age and children 1 through 3
years of age.
Finally, because we are proposing DRVs for various nutrients for
infants 7 through 12 months, children 1 through 3 years, and pregnant
and lactating women (see section II.K.), we are proposing to amend
Sec. 101.36(b)(2)(iii)(F) such that the requirement for an asterisk
noting that a DV has not been established would be applicable to foods
for these subpopulations only when a DRV has not been established for a
nutrient (i.e., for saturated fat, cholesterol, or dietary fiber for
dietary supplements that are represented or purported to be for use by
infants 7 through 12 months). Proposed Sec. 101.36(b)(2)(iii)(F)
states: ``For declared subcomponents that have no DRVs, a symbol (e.g.,
an asterisk) shall be placed in the ``Percent Daily Value'' column that
shall refer to the same symbol that is placed at the bottom of the
nutrition label, below the last heavy bar and inside the box, and
followed by the statement ``Daily Value not established.''
6. Footnote
As discussed in section II.M, we are proposing to modify the
footnote on the Nutrition Facts label. We are planning to conduct
consumer studies related to the footnote on the Nutrition Facts label.
The current footnote statement required for the Supplement Facts label
differs from that which is currently required on the Nutrition Facts
label. We expect that consumers that purchase dietary supplements would
be more interested in information about the amount of specific
micronutrients contained in dietary supplements and would be less

[[Page 11948]]

focused on the caloric reference value used in determining the percent
DV for macronutrients. Based on the results of the consumer study, we
will consider whether it is necessary to make corresponding changes to
the footnote used on the Supplement Facts label when certain
macronutrients are declared. We invite comment on whether we should
consider changes to the footnote statement on the Supplement Facts
label to be consistent with any changes to the footnote statement in
the Nutrition Facts label.

M. Format

Nutrition information must be presented on food labels in a
specific format (see e.g., Sec. 101.9(d)-(f) and (j)). The elements of
format related to the Nutrition Facts label include such features and
graphic design principles as the type style (i.e., font) and size of
the type (i.e., point); use of boldface, lines, and bars; arrangement
of information in one or more columns; column headings; presence of a
footnote and use of a symbol (such as an asterisk) to designate a
footnote; and whether nutrition information is listed as a percentage
or in absolute (i.e., quantitative) amounts. The elements of format
also include the alignment of information; whether indentations are
used in listing nutrient data; and the use of white space (or negative
space) where no image or text exists. White space helps to isolate an
element of the label that demands attention and provides a hierarchy
and pacing of information for the reader (Ref. 160). The format may
differ from package to package according to the amount of space on the
package that is available for labeling, as described and detailed in
the relevant sections in this document.
The format of the Nutrition Facts label was informed by a number of
factors, including consumer research conducted by FDA (Refs. 161 to
163); consideration of the environment in which consumers typically use
the label (i.e., grocery stores); the diversity of consumers for whom
the label is intended (i.e., with respect to education, age,
socioeconomic status, etc.); and comments and data received on this
issue in response to a 1990 proposed rule, as discussed in the 1993
final rule entitled Food Labeling: Mandatory Status of Nutrition
Labeling and Nutrient Content Revision, Format for Nutrition Label (58
FR 2079 at 2114-2144) (the format rule). Research studies consistently
confirmed that simple formats are easier to comprehend and require less
consumer effort than complex information formats. A simple format is
one that minimizes clutter and best meets the NLEA requirements that
nutrition information should enable the public to readily observe and
comprehend such information. In addition, a simple format allows
consumers to search for accurate nutrition information with minimum
effort, and provides information in a succinct manner that maximizes
understanding.
Although the original intent of the format rule to meet the
requirements and objectives of the NLEA for format has not changed, FDA
is proposing certain changes to the format because of new information
that has become available to us since 1993. The new information
includes results of consumer research including studies that we
conducted (Ref. 164), trends in health conditions (especially obesity),
comments received in response to the 2005 and 2007 ANPRMs, and
recommendations from FDA's Obesity Working Group (OWG) (Ref. 165). We
are using this notice of proposed rulemaking to re-examine aspects of
the current label format to determine which, if any, design changes may
facilitate how information is conveyed to consumers.
We are not proposing an extensive reformatting of the Nutrition
Facts label. The original design, which took into account fundamental
design principles for communicating complex ideas with clarity,
precision, and efficiency, are largely being retained (Ref. 166).
Rather, our tentative views, tentative conclusions, and proposed
changes include our consideration of graphic design principles such as
alignment, consistency, repetition, and contrast, and place an emphasis
on highlighting key nutrients and key information and removing or
modifying parts of the label to assist consumers in maintaining healthy
dietary practices (Ref. 167). We consider our proposed changes to the
Nutrition Facts label to be visually appealing and inviting. In
general, the goal is to continue to display the information in a simple
manner that is legible, readable, and follows a logical hierarchy. This
presentation should serve as a visual guide to the reader that allows
the eye to easily scan the label while the actual effort of reading is
reduced.
Toward that end, we are proposing the following changes to the
format of the Nutrition Facts label: (1) Increasing the prominence of
calories and serving size; (2) reversing the order of the ``Serving
Size'' declaration and the ``Servings Per Container'' declaration and
increasing the prominence of ``Servings Per Container''; (3) right-
justifying the quantitative amounts of the serving size information;
(4) changing the phrase ``Amount Per Serving'' to ``Amount Per ----''
with the blank filled in with the serving size; (5) removing the
declaration of ``Calories from fat''; (6) modifying the presentation of
the ``% DV'' information by changing its position to the left of the
name of the nutrient on certain labels, and separating it from the list
of nutrients with a vertical line; (7) declaring ``Added Sugars'' as an
indented listing directly beneath the listing for ``Sugars''; (8)
declaring the quantitative amounts (in addition to percent DVs) of
mandatory vitamins and minerals and, when declared, voluntary vitamins
and minerals; (9) requiring dual column labeling under certain
conditions; (10) modifying the footnote; (11) requiring that all
nutrients not currently highlighted in bold or extra bold type be
highlighted in a type that is intermediate between bold or extra bold
and regular (i.e., semi-bold) type; (12) adding a horizontal line
directly beneath the ``Nutrition Facts'' heading; and (13) replacing
the listing of ``Total Carbohydrate'' with ``Total Carbs.'' We discuss
each of these proposed amendments in this document. In addition, we are
requesting comments on other issues related to the Nutrition Facts
label format, including the use of an alternative format design or
requiring the use of a specific font.
Although the discussion in this document focuses primarily on the
format of the standard Nutrition Facts label illustrated in Sec.
101.9(d)(12), we also discuss certain modifications that we are
proposing to be applied to other label formats to maintain consistency
with the new format of the standard Nutrition Facts label. These other
modifications pertain to formats for packages of products that contain
two or more separately packaged foods that are intended to be eaten
individually (e.g., variety packs of cereals and snacks) or that are
used interchangeably for the same type of foods (e.g., round ice cream
containers (Sec. 101.9(d)(13)); formats that apply to subpopulations
(Sec. 101.9(e) and Sec. 101.9(j)(5)); the simplified format (Sec.
101.9(f)); the tabular display on packages that do not have sufficient
continuous vertical space (Sec. 101.9(d)(11)(iii)); and the tabular
display (Sec. 101.9(j)(13)(ii)(A)(1)) and linear display (Sec.
101.9(j)(13)(ii)(A)(2)) for small packages.
1. Increasing the Prominence of Calories and Serving Size
The ability to determine the caloric content of packaged foods is
important for all consumers, especially those who are trying to control
their total caloric

[[Page 11949]]

intake and manage their weight. Inasmuch as overweight and obesity are
major public health problems in the United States and are fundamentally
a direct result of calorie consumption exceeding energy expenditure, we
are interested in increasing consumer attention to the calorie content
of packaged foods.
Current FDA regulations require ``Calories'' to be declared in a
type size no smaller than 8 point (Sec. 101.9(d)(1)(iii)) and
highlighted in bold or extra bold type or other highlighting (Sec.
101.9(d)(1)(iv)). While calorie information is mandatory on the
Nutrition Facts label, it is possible that modifying the Nutrition
Facts label to give more prominence to calories may benefit consumers
in weight control and maintenance, as noted by the OWG in its final
report entitled ``Calories Count'' (Ref. 165).
The OWG recommended, in part, that FDA issue an ANPRM to solicit
comments on how to give more prominence to calories on the food label.
The OWG suggested possible changes to the Nutrition Facts label, such
as increasing the prominence of ``Calories'' and ``Serving Size,''
providing a percent DV for calories, and eliminating the ``Calories
from fat'' declaration, which may detract from the emphasis on total
calories. The OWG recommended that we obtain information on the
effectiveness of these options on consumer understanding and behavior
related to calorie intake (Ref. 165). After issuing the 2005 ANPRM, in
which we solicited comment on the OWG recommendations, we received
several comments that generally supported increasing the prominence of
calories on the Nutrition Facts label. These comments suggested various
approaches for doing so, and pointed out the need for additional
research to fully understand the effects of potential label changes on
consumer understanding and behavior (Ref. 47).
We considered available data from consumer research and comments
received in response to the ANPRMs. Research conducted for warning
labels and drug label formats has consistently demonstrated that
increasing type size, among other things, increases attention to, and
improves understanding of warning information, especially for older
consumers and those with limited vision (Refs. 168 to 170). Also, our
research on food labels with two servings per container found that
labeling changes that highlighted the number of servings per container
(via text or a dual column) served as cues to consumers that the
product contained more than one serving and helped them more accurately
determine the number of calories per container (Ref. 164).
We tentatively conclude that the proposed changes to the number of
calories per serving and the number of servings per container would
result in these declarations serving as an anchor to the Nutrition
Facts label by focusing the reader's attention to this information and
therefore would assist consumers to effectively use this information in
the Nutrition Facts label (Ref. 171). Accordingly, we are proposing to
revise Sec. 101.9(d) to increase the type size for ``Calories'' and
the numeric value for ``Calories.'' We are also proposing that the
numeric value for calories be highlighted in bold or extra bold type in
order to draw attention to this information, emphasize the importance
of calories on the label, and maintain consistency with the bolded
declaration for ``Calories.'' We invite comment on these tentative
conclusions.
We also consider it appropriate to make corresponding changes to
the prominence of calories on the Supplement Facts label, when
``Calories'' is declared. Although the majority of dietary supplement
products contain a negligible amount of calories, and therefore
calories are not declared on most Supplement Facts labels, we note that
some dietary supplement products may contain a significant amount of
calories and macronutrients. We are concerned that a small number of
dietary supplement products, especially those in liquid form, could
contribute a significant amount of calories and other macronutrients to
the diet when consumed regularly. For such products, our tentative view
is that it may be necessary for the Supplement Facts label to have a
format similar to the format being proposed for the Nutrition Facts
label with respect to increasing the prominence of information for
calories. We invite comment on whether any of the changes that are
being proposed to the Nutrition Facts label in the following sections
should also be required for certain products with Supplement Facts
labels that list calories and/or other macronutrients, and if so, under
what conditions and for which dietary supplement products should such
labeling be required.
2. Changing the Order of the ``Serving Size'' and ``Servings Per
Container'' Declarations and Increasing the Prominence of ``Servings
Per Container''
Current regulations specify that information on serving size,
consisting of a statement of the serving size (Sec. 101.9(d)(3)(i))
and the number of servings per container (Sec. 101.9(d)(3)(ii)), shall
immediately follow the identifying heading of ``Nutrition Facts.'' In
addition, ``Serving Size'' and ``Servings Per Container'' must be in a
type size no smaller than 8 point (Sec. 101.9(d)(1)(iii)). As
mentioned previously, we are interested in taking steps to increase
consumer attention to the calorie content in packaged foods, such as by
increasing the prominence of this information as suggested by the OWG.
Consumer research on information displays suggests that accuracy of
judgments and quality of decisions are improved when information
displays closely match the judgment and decision needs of consumers
(Refs. 172 and 173). With respect to the Nutrition Facts label, an
important consumer need is to identify the number of servings per
container of a packaged food. Therefore, placing ``Servings Per
Container'' above ``Serving Size'' would be expected to help consumers
find the number of servings per container with less effort than is now
needed. Listing ``---- servings per container'' with the blank filled
in with the actual number of servings directly beneath the ``Nutrition
Facts'' heading, and highlighting it in bold or extra bold type would
also help increase awareness that the information presented in the
Nutrition Facts label does not refer to the contents of the entire
package when the label indicates that there is more than one serving
per container. Further, listing ``Serving size'' in the same proximity
to where the actual nutrient information is located on the label would
help consumers understand that this nutrient information pertains to
the particular serving size that is declared. Proximity is a graphic
design principle that asserts that items closer together are perceived
to be more related (Ref. 167). This, in turn, would help consumers
grasp the relative significance of a particular food product in the
context of their daily diet.
Therefore, based on the available data and information discussed
previously, including graphic design principle, of proximity we
tentatively conclude that reversing the order of the declarations of
``Servings Per Container'' and ``Serving Size'' would help consumers
more readily observe and comprehend the nutrition information appearing
in the Nutrition Facts label, allow consumers to search for information
with a minimum of effort, and assist consumers in their food purchasing
decisions and in maintaining healthy dietary practices. Accordingly, we
are proposing to re-designate Sec. 101.9(d)(3)(i) as Sec.
101.9(d)(3)(ii), re-designate Sec. 101.9(d)(3)(ii) as Sec.
101.9(d)(3)(i), and

[[Page 11950]]

make changes in how the serving size information is capitalized on the
label so that no capital letters are used, except for the first letter
in ``Serving size.'' (Current Sec. 101.9(d)(3)(i) and (d)(3)(ii)
specify that information on serving size be capitalized and listed as
``Serving Size'' and ``Servings Per Container.'') We also are proposing
to require that the declaration of ``---- servings per container''
(with the blank filled in with the actual number of servings) be
highlighted in bold or extra bold type, and be in a type size no
smaller than 11 point (except for the tabular and linear displays for
small packages) (proposed Sec. 101.9(d)(3)(i)) and that the serving
size information must be in a type size no smaller than 8 point (except
for the linear display for small packages) (proposed Sec.
101.9(d)(3)(ii)). We tentatively conclude that these proposed changes
would lessen the effort of consumers to locate this information, and
assist them in accurately identifying the calorie amounts and nutrient
contents of packaged food products.
Current regulations regarding serving size information for dietary
supplements is described in Sec. 101.36(b)(1). When taking dietary
supplements, consumers need to know how much of the product to take
(e.g., 1 capsule, 2 tablets, 1 packet). This information, which is
currently provided in the ``Serving Size'' line of the Supplement Facts
label, is more important for the consumer to know than the number of
servings (e.g., 100 tablets) contained in the package. We received no
comments recommending that the serving size or servings per container
information on the Supplement Facts label should be made more prominent
or noticeable. Therefore, our tentative conclusion is that there is no
need to propose changing the order of how serving size and servings per
container are listed on the Supplement Facts label, or to make
amendments in the type size or capitalization corresponding to our
proposed changes for this information on the Nutrition Facts labels. We
invite comment on these tentative conclusions.
3. Right-Justifying the Quantitative Amounts Declared in the ``Serving
size'' Statement
We have also tentatively concluded, based on design considerations,
that the label statement for ``Serving size'' in both household unit
(Sec. 101.9(b)(5), refers to a common household measure such as a cup,
tablespoon, piece or slice) and gram amounts must be right-justified on
the same line that ``Serving size'' is listed. Currently, this
numerical information is stated immediately adjacent to the ``Serving
Size'' declaration, as seen in current Sec. 101.9(d)(12). By keeping
the proposed ``Serving size'' declaration left-justified while right-
justifying the corresponding numerical values, the proposed change
would create white space on the Nutrition Facts label that would result
in a less cluttered appearance, heightened focus and emphasis, and
improved readability (Ref. 160). This design feature would provide
enhanced emphasis to the information about serving size, allowing this
information to be more noticeable and thereby facilitating its access
and use by consumers. We invite comment on this tentative conclusion.
4. Changing the ``Amount Per Serving'' Statement
Current regulations specify that the Nutrition Facts label shall
include a subheading designated as ``Amount Per Serving'' and that this
subheading shall be separated from the serving size information by a
bar (Sec. 101.9(d)(4)) and be highlighted in bold or extra bold type
or other highlighting (Sec. 109(d)(1)(iv)). We are proposing, based in
part on the consumer research previously cited (Refs. 172 and 173), to
change the ``Amount Per Serving'' declaration to ``Amount per ----''
with the blank filled in with the actual serving size expressed in
household units, and to increase the type size. These changes would
make it easier for label users to judge the amounts of nutrients per
serving because it removes the need for label users to refer back to
the unit of the serving size which is currently declared just below the
Nutrition Facts heading and which would be declared under the number of
servings per container in the proposed label formats.
Other studies suggest that consumers are often confused by serving
size information as it is currently presented on the Nutrition Facts
label (Refs. 174 and 175). Therefore, specifying the actual serving
size in the listing of ``Amount per ----'' declaration would be
expected to help consumers more readily observe and comprehend the
nutrition information appearing in the label. Based on the reasons
provided, we tentatively conclude that changing the ``Amount Per
Serving'' statement to ``Amount per ----'' with the blank filled in
with the actual serving size and increasing the type size would assist
consumers in using the information and may lessen the time and effort
needed to locate the target information. Accordingly, we are proposing
to amend Sec. 101.9(d)(4) by requiring that the Nutrition Facts label
specify what the serving size actually is by declaring ``Amount per --
--'' with the blank filled in with the actual serving size in household
units as indicated in the ``Serving size'' declaration. To further
facilitate use of the Nutrition Facts label, as mentioned in section 2,
we are proposing to move the ``Serving size'' declaration closer to the
proposed ``Amount per ----'' listing. We also are proposing to require
that the ``Amount per ----'' information be highlighted in semi-bold,
rather than in bold or extra bold, in order not to detract from the
calories information. In addition, we are proposing that the type size
of the ``Amount per ----'' declaration be no smaller than 8 point
(except for the linear display for small packages). We invite comment
on our tentative conclusions.
5. Declaration of ``Calories from Fat''
We have tentatively concluded that a declaration of calories from
fat on the Nutrition Facts label is not necessary to assist consumers
in maintaining healthy dietary practices and, consequently, we are
proposing to remove the current requirement for declaration of
``Calories from fat'' (see section II.A.1.). Our Consumer research
(Ref. 164), which evaluated a label format that did not contain the
``Calories from fat'' statement, found that the lack of this
information had no effect on consumers' judgments of product
healthfulness, accuracy in identifying nutrient contents of products,
or perceptions of the label. These findings support our proposal to
remove the ``Calories from fat'' declaration from the Nutrition Facts
label.
6. Presentation of Percent DVs
The format for listing nutrients with DRVs on the Nutrition Facts
label, including the quantitative amount by weight and percent DVs, is
described in Sec. 101.9(d)(7). In establishing the requirements for
percent DV declaration, we considered that this information would help
consumers evaluate the nutrient characteristics of a single product
(e.g., how high or low a particular product is in certain nutrients or
the extent to which it contributes toward daily nutritional goals) and
assist them in making choices between products (58 FR 2079 at 2121).
Consumer research at that time of rulemaking for the Nutrition Facts
label (Ref. 162) indicated that the percent DV information improved
consumers' abilities to make correct dietary judgments about a food in
the context of a total daily diet. Research also indicated that percent
DV information helped consumers to verify the accuracy

[[Page 11951]]

of front-panel claims (Ref. 163). We received comments on the format of
the Nutrition Facts label in response to the 2007 ANPRM (Ref. 47) that
suggested modifying the way percent DV is presented to facilitate
greater use of this information, although one comment suggested that
the percent DV should not be used on the label. Other comments noted
the need for additional consumer research and a comprehensive consumer
education program.
We continue to believe that the percent DV information on the
Nutrition Facts label can serve a number of useful purposes, including
helping consumers to compare foods; determine if a serving of food is
high or low in a particular nutrient; and make dietary trade-offs among
food choices throughout the day. As such, we do not agree that the
percent DV declarations should be eliminated from the Nutrition Facts
label. We are proposing to switch using the ``% Daily Value'' to the
``% DV'' in the column that is above the nutrient listings. The ``%
DV'' is used on some of nutrition facts labels for smaller packages and
we think this will help with maintaining consistency among the labels.
In addition we are adding a hairline rule (see discussion in this
document) to differentiate the DVs from the nutrients and using ``%
DV'' as the header which maintains the alignment of the heading over
the DV column. Therefore based on the graphic design principle of
alignment (Ref. 167) and in order to promote consistency of the labels
we tentatively conclude to use ``% DV'' as the column header over the
numerical listing of the nutrients DVs (proposed Sec. 101.9(d)(7)(ii))
.
We have considered alternative terms that may be more readily
understandable than Daily Value, such as Daily Guide or Daily Need, and
invite comment on these or other terms. The issue of using an
appropriate single term to refer to all of the reference values in the
nutrition label was previously discussed in the format rule (58 FR 2079
at 2124), in which we explained our rationale for deciding upon the
single term ``Daily Value.'' We also request comment on whether the
word ``percent'' (or the % symbol) should precede whatever term is used
in the column heading where the percent DVs are listed, as specified in
current Sec. 101.9(d)(6). Since the % symbol is currently included
next to the numerical values that are listed in this column, including
the word ``percent'' or the % symbol in the column heading may be
redundant and, after considering comments, we may remove that
requirement in a final rule. For the reasons explained previously, we
are not proposing to change the requirements for the declaration of
percent DV for all nutrients, as specified in Sec. 101.9(c)(8) and
Sec. 101.9(d)(7).
As discussed previously, percent DV is intended to help consumers
make dietary decisions. Therefore, we tentatively conclude that making
the percent DV more prominent may make the information even more useful
to consumers than it is now. One potential approach to making the
percent DV more prominent is to rearrange the positions of the columns
listing the percent DV information. As currently described in Sec.
101.9(d)(6), and Sec. 101.9(d)(7) the percent should be arranged on
the right of certain Nutrition Facts label formats. For labels
displaying the tabular format (proposed Sec. 101.9(d)(11)(iii)), the
standard format (proposed Sec. 101.9(d)(12)), the format for infants 7
to 12 months of age (proposed Sec. 101.9(j)(5)(i)), the tabular format
for small packages, (proposed Sec. 101.9(j)(13)(ii)(A)(1)), the linear
display (proposed Sec. 101.9(j)(13)(ii)(A)(2)), and the simplified
format (as described in current Sec. 101.9(f)), we propose to list
percent DVs in a column to the left of the names of the nutrients and
their quantitative amounts, with a thin vertical line separating the
``% DV'' column from the list of nutrients.
The rearrangement is based on the graphic design principles of
primacy (which asserts that initial items in a list are stored more
efficiently in memory than items listed later), proximity (which
asserts that elements positioned close together are perceived as a
single group), and the importance of white space (which, among other
things, is used by designers to isolate an element that demands
attention) (Ref. 160 and 167), and the fact that English text is read
from left to right. The addition of a vertical hairline rule to the
right of the ``% DV'' column assists in chunking this information,
thereby accentuating it and further distinguishing it from the nutrient
name and the quantitative weight information. Chunking is a technique
for combining multiple units of information into a limited number of
units or chunks so that the information is easier to process and
remember) (Ref. 167). Based on these design principles, positioning the
% DV to the left of the label should increase consumers focus on the %
DV. Displaying the % DV in this manner would assist consumers in
understanding the relevant contribution of a nutrient in a food to the
diet by highlighting the % DV information on the label more than on the
current label format (where % DV is listed on the right of the label).
We tentatively conclude that the proposed rearrangement would
assist consumers by helping them to understand the nutrition
information on the label in the context of a total daily diet. We are
unaware of any consumer survey data concerning this particular proposed
change related to consumer understanding and use of the information.
Although, we are aware that the prevalence of inadequate numeracy
(defined as ``the ability to comprehend, use, and attach meaning to
numbers'' (Ref. 176) and low literacy in the population have been
persistent concerns regarding the ability of consumers to comprehend
health-related information, it is unclear to what extent the changes we
are proposing to the positioning of the % DV from its current placement
would have on overall consumer use or understanding. We are also aware
that the prominence of the percent DV first could potentially make the
Nutrition Facts label appear less user-friendly particularly to
frequent users of Nutrition Facts labels, who have grown accustomed to
the format and organization of the existing Nutrition Facts label. In
addition, we acknowledge that moving the % DVs to the left could
potentially draw consumer attention from nutrients that do not have a
DV. We invite comment and data on the tentative conclusion to shift the
``% DV'' to the left of the Nutrition Facts label.
On all dual column labels, including those (1) for two or more
forms of the same food (proposed Sec. 101.9(e)(5)); (2) displaying
nutrition information per container and per unit, in addition to
nutrition information per serving (proposed Sec. 101.9(e)(6)(i); (3)
using the tabular display (proposed Sec. 101.9(e)(6)(ii)), and; (4)
that provide the aggregate display (proposed Sec. 101.9(d)(13)(ii)),
we propose to list the names of nutrients on the right side of the % DV
column, followed by the quantitative (weight) amounts of each nutrient.
In each of these labels, we propose to use thin vertical lines to
separate the information in the ``% DV'' column from the information in
the column containing the quantitative weights. Further, we propose to
use the same style of thin vertical lines to separate each of the dual
columns and aggregate display columns from each other. The use of these
vertical lines helps to differentiate the columns and make the
information easier for consumers to read and identify (Ref. 167). We
invite comment on this tentative conclusion.
As described in the Dietary Supplement Health and Education Act of
1994, dietary supplements are

[[Page 11952]]

products taken by mouth containing ``dietary ingredients'' that are
intended to supplement the diet. They may contain not only vitamins and
minerals, but also herbs or other botanicals and amino acids, as well
as concentrates, metabolites, constituents, and extracts of these
dietary ingredients (section 201(ff) of the FD&C Act). Thus, many
dietary supplement products contain few or no dietary ingredients with
DRVs or RDIs, and therefore would not list any percent DVs on the
Supplement Facts label. Further, consumers taking dietary supplements
may find information about the quantitative amounts of dietary
ingredients in the product to be of equal or greater importance than a
percent DV listing, even if a DV existed for an ingredient contained in
the dietary supplement. Therefore, we are not proposing any changes in
the position of the percent DV listing on the Supplement Facts label
relative to the position of the nutrient and dietary ingredient
information. As mentioned previously, we are proposing to require that
the Nutrition Facts labels that include dual columns contain vertical
lines separating the percent DV information from the quantitative
amounts per weight listings in each of the dual columns, and to
separate the dual columns from each other. We invite comment on whether
there is a need to include vertical lines that are similarly placed on
Supplement Facts labels for multiple vitamins in packets (Sec.
101.36(e)(11)(iii)) and for dietary supplements that list ``per
serving'' and ``per day'' information (Sec. 101.36(e)(11)(viii)).
Current Sec. 101.9(j)(5)(ii)(A), (j)(5)(ii)(C), and (j)(5)(ii)(D)
include certain provisions for the presentation of percent DV for
nutrients on the Nutrition Facts label of foods represented or
purported to be specifically for infants and children less than 4 years
of age. In particular, the percent DVs for protein, vitamins, and
minerals are listed in a separate section of the Nutrition Facts label
below the quantitative information by weight for protein. As discussed
in section II.K., we are proposing changes to the nutrition labeling of
foods represented or purported to be specifically for infants 7 through
12 months, children 1 through 3 years of age, and pregnant and
lactating women. These include, among other things: (1) Establishing
RDIs and DRVs that are used in determining the percent DVs declared on
the label; and (2) allowing for certain percent DV declarations that
are currently excluded in Sec. 101.9(j)(5)(ii)(A). Given these
proposed amendments that would require percent DV declarations for
macronutrients, we invite comment on the appropriate placement of
percent DVs in the labeling of foods for infants 7 through 12 months,
children 1 through 3 years of age, and pregnant and lactating women. We
are considering listing the percent DV to the left of the name of any
nutrient that has a DV, as shown in proposed Sec. 101.9(j)(5)(i),
similar to the placement of the declaration of percent DVs in the
labeling of foods for the general population. Therefore, we are
proposing that the percent DV for protein would no longer be listed
with the vitamins and minerals at the bottom of the label as currently
required.
7. Placement of ``Added Sugars''
As discussed in section II.D.3., we are proposing to require the
declaration of added sugars as an indented line item underneath the
declaration of total sugars on the Nutrition Facts label. If finalized,
added sugars would be the first mandatory nutrient required to be
listed in a double indentation format on the Nutrition Facts label. FDA
regulations permit the voluntary declaration of ``soluble fiber'' and
``insoluble fiber'' as double indented listings under ``dietary fiber''
(Sec. 101.9(c)(6)(i)). We are planning to conduct a consumer study (78
FR 32394, May 30, 2013) that will include, among other things,
questions regarding the declaration of added sugars on the Nutrition
Facts label. The results of this study will help enhance our
understanding of how consumers would comprehend and use this new
information. We will publish the results of the study when they become
available. We are interested in receiving, as part of any comment,
other available research data and other factual information relevant to
this issue, including the proposed double indented placement of added
sugars below total sugars.
8. Declaration of Absolute Amounts of Vitamins and Minerals
A declaration of the quantitative amount by weight is required for
both mandatory and voluntary nutrients that are declared on the
Nutrition Facts label, except for vitamins and minerals (other than
sodium and potassium) which must be declared only as percent DVs. As
discussed in section II.I.6., we are proposing to require the
declaration of the absolute amounts for all mandatory and voluntary
vitamins and minerals, in addition to the requirement for percent DV
declaration. An exception to this proposed requirement would be
Nutrition Facts labels for foods in small packages that have a total
surface area available to bear labeling of 40 or less square inches.
Because of space limitations, we are not proposing any changes to the
tabular display (Sec. 101.9(j)(13)(ii)(A)(1)) and the linear display
(Sec. 101.9(j)(13)(ii)(A)(2)) on packages that have a total surface
area available to bear labeling of 40 or less square inches, where
vitamins and minerals (other than sodium) would have to be declared
only as percent DVs.
9. Single and Dual Column Labeling
There are currently multiple provisions for voluntary dual column
labeling. For example, there is dual column labeling that presents
nutrition information per serving size and per 100 g or 100 mL, or per
1 oz. or 1 fl oz. of the food as packaged or purchased (Sec.
101.9(b)(10)(i)). Dual column labeling is mandatory for products that
are promoted on the label, or in advertising, for a use that differs in
quantity by twofold or greater from the use upon which the reference
amount was based (e.g., liquid cream substitutes promoted for use with
breakfast cereals) (Sec. 101.9(b)(11)). We are also proposing for
foods that are commonly combined with other ingredients or that are
cooked otherwise prepared before eating to present the percent DVs and
the quantitative amounts for both the food in the ``as purchased'' form
and for the ``as prepared'' form in Sec. 101.9(h)(4).
We are proposing under certain conditions (i.e., when the package
contains at least 200 percent and up to and including 400 percent of
the applicable reference amount customarily consumed) to require dual
column labeling where nutrition information would be presented based
both on the serving size and on the entire package or unit of food.
This is described in a proposed rule entitled ``Food Labeling: Serving
Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion;
Dual Column Labeling; Updating, Modifying, and Establishing Certain
Reference Amounts Customarily Consumed; Serving Size for Breath Mints;
and Technical Amendments'' (serving size proposed rule) that is
published elsewhere in this issue of the Federal Register.
In addition to proposing dual-column labeling per serving and per
container (or unit, as applicable) for all nutrition information on the
label, we are considering two additional options that would require
nutrition information per serving and per container for only certain
declarations but not all label declarations for containers of food or
units of food, as applicable, containing

[[Page 11953]]

at least 200 percent and up to and including 400 percent of the
applicable RACC. The first option is for a label that includes calorie
information per serving and per container (or unit, as applicable)
following the serving size information in the Nutrition Facts label.
With this option, the remaining nutrition information would be listed
on a per serving basis only and in a single column below the calorie
information per serving and per container. The second option is to
provide nutrition information per serving and per container (or unit,
as applicable) for calories, saturated fat and sodium following the
serving size information in the Nutrition Facts label and the remaining
nutrition information would be listed on a per serving basis in a
single column below the dual column provided for calories, saturated
fat and sodium declarations. These options may specifically highlight
the calorie content alone, and the calorie content, saturated fat
content, and sodium content, respectively, for both the serving size
and the entire container of food (or unit, as applicable). These
options would focus on a smaller number of nutrients presented per
serving and per container of food (or unit, applicable) that the U.S.
population should limit for those foods with at least 200 percent and
up to and including 400 percent of the RACC. We question whether
consumers would be more inclined to use dual column labeling for a
smaller set of nutrients. We invite comment and data on dual column
labeling as proposed in this rule as well as the options presented for
providing nutrition information per serving and per container (or unit,
as applicable) for only certain declarations.
We will consider whether to require one of these options in the
serving size final rule after considering comments on the serving size
proposed rule.
10. The Footnote
The Nutrition Facts label requires an asterisk following the ``%
Daily Value'' declaration that refers to a footnote statement that
reads: ``*Percent Daily Values are based on a 2,000 calorie diet. Your
Daily Values may be higher or lower depending on your calorie needs''
(Sec. 101.9(d)(9)(i)). Below this footnote, a table that lists DRVs
for total fat, saturated fat, cholesterol, sodium, total carbohydrate,
and dietary fiber based on 2,000 and 2,500 calorie diets must be
provided (Sec. 101.9(d)(9)(i)). This table was originally included in
the Nutrition Facts label to assist consumers in estimating their own
quantitative dietary needs relative to the reference DVs (58 FR 2079 at
2127). It was also intended to communicate that some DVs vary with
caloric intake whereas others do not. Specifically, only the DRVs for
the macronutrients (i.e., total fat, saturated fat, total carbohydrate,
dietary fiber, and protein) differ according to calorie needs while the
current DRVs for cholesterol, sodium, and potassium, as well as the
RDIs for essential vitamins and minerals, do not vary according to
caloric intake, and therefore are the same for both the 2,000 and 2,500
calorie levels listed in the footnote. Finally, a statement indicating
that the kcal/g for fat, carbohydrate, and protein are 9, 4, and 4,
respectively, is permitted to be declared below the DRVs table (Sec.
101.9(d)(10)).
Several comments to the 2007 ANPRM suggested deleting either the
entire footnote or the DRVs table from the footnote, and stated that
the footnote information is not readily useable or understood by
consumers and may be potentially confusing. Other comments recommended
replacing the footnote with a short, simple statement that directs
consumers to the USDA's MyPyramid Web site (which has now been replaced
with ChooseMyPlate.gov) for further information. We do not agree with
these latter comments, as information on the Nutrition Facts label
should be available to the consumer at the time of product purchase or
consumption.
The percent DV is not described in the footnote or anywhere else on
the Nutrition Facts label and we are interested in whether such a
description would help improve consumer understanding of the percent DV
information. In addition, as one comment pointed out, a recent study by
the International Food Information Council Foundation entitled ``Food
Label and Consumer Research Project'' showed that some consumers did
not understand what was being conveyed in the percent DV explanatory
footnote and others thought that the DRVs table changed according to
the content of each food and beverage product. Therefore, although data
indicate that the DRVs table is not well understood by consumers, it
also appears unlikely that consumers would understand this information
any better if calorie values were lowered or if a separate listing for
men and women were provided, as was suggested by some comments.
Therefore, we are proposing to remove the requirement for the footnote
table listing the DRVs for total fat, saturated fat, cholesterol,
sodium, total carbohydrate, and dietary fiber for 2,000 and 2,500
calorie diets that is specified in Sec. 101.9(d)(9)(i).
We also note that consumers are better able to discriminate between
more and less healthful products when they are given an explanation
about percent DVs than when they are not (Ref. 177). Therefore, it is
our tentative view that a new footnote statement containing
informational text to help consumers interpret the meaning of the
percent DV and use the DVs is needed. Such information may include a
definition of the percent DV, a succinct statement regarding calorie
intake, and/or an explanation of when the percent DV signifies a
relatively high or low level of a nutrient, such as the ``5/20 rule,''
which we describe in this document. In addition, it is our tentative
view that such a footnote statement should be simple and easy to
understand, as simplified information is more useful and accessible to
consumers than complex information (Ref. 178).
We also recognize that the footnote appearing in small type size at
the bottom of the label may have made it less noticeable to consumers
and therefore of less use than if it had been larger and otherwise more
noticeable. Therefore, it is our tentative view that increasing the
type size, bolding key elements of the footnote (space permitting), and
adding a bar clearly separating it from the micronutrient information
directly above will assist consumers in using the information. Again,
we request comment on the impact such changes would have on enhancing
consumers' use of the percent DV. We will consider comments we receive
and whether to include such changes in the final rule.
We also consider that a succinct statement about daily calorie
intake (2,000 calories) is a necessary part of the footnote because
2,000 calories is consistent with widely used food plans (76 FR 19192
at 19209), the percent DV of certain nutrients (e.g., total fat, total
carbohydrate, and dietary fiber) is based on 2,000 calories, and 2,000
calories approximates the estimated energy need for adults who are
sedentary to moderately active. However, we recognize that a succinct
statement about daily calorie intake should not suggest that the
percent DV of all nutrients is linked to a 2,000 calorie diet.
As previously discussed in section II.M.7, we are planning to
conduct consumer research on various format issues, including percent
DV information in the footnote area. We agree that consumer education
programs are important, and have offered such programs on our Web site
to a variety of audiences, including young individuals (Ref. 179). We
will consider additional efforts, as appropriate. In an

[[Page 11954]]

effort to provide consumers with a general approach for using the
percent DV to evaluate the nutrient content in foods, we have explained
on our Web site that, as a general frame of reference, a 5 percent DV
or less is low and a 20 percent DV or more is high (often called the
``5/20 rule'') (Ref. 180). Even though this general frame of reference
has been publicized and advocated by the 2010 DGA (Ref. 6) and various
Web sites (Ref. 181), it is unclear whether consumers are aware of the
``5/20 rule,'' and to what extent it can improve consumer judgments
about what constitutes high or low levels of nutrients in foods since
quantitative information about food constituents is difficult for
consumer to interpret (Ref. 180). The ``5/20 rule'' also closely
approximates FDA regulations for nutrient content claims that provide
criteria for the terms ``low'' (Sec. Sec. 101.61 and 101.62) and the
terms ``rich in'' and ``excellent source'' (Sec. 101.54). Thus, the
``5/20 rule'' could assist consumers in choosing foods that are high in
specific nutrients they want to consume more of (e.g., calcium) and/or
low in nutrients they want to eat less of (e.g., saturated fat). To
inform our decision on how best to construct the new footnote,
including its content and format, we plan to conduct consumer research
during this rulemaking that will test consumer reactions to a
definition of percent DV, a succinct statement on calories, and several
statements related to the ``5/20 rule'' (77 FR 32120, May 31, 2012, and
78 FR 32394). We will make the results of this study available for
public review and comment. We request comments, including available
data and information (such as experimental evidence) related to this
issue.
We are not aware of data gathered since the NLEA's implementation
on whether listing information about converting gram amounts of fat,
carbohydrate, and protein to calories has been useful to consumers. We
are not proposing changes to this aspect of the footnote specified in
Sec. 101.9(d)(10). However, we request comments and supporting data on
whether or not this calorie conversion information should continue to
be optional on the Nutrition Facts label, and whether there are any
data suggesting that consumers do or do not use this information. We
may consider deleting this optional requirement in the final rule if we
determine the information is not useful. We will consider corresponding
changes to the footnote requirements for the Supplement Facts label
consistent with any changes to the footnote on the Nutrition Facts
label.
11. Use of Highlighting With a Type Intermediate Between Bold or Extra
Bold and Regular Type
Currently, only nutrients that are not indented (i.e.,
``Calories,'' ``Total Fat,'' ``Cholesterol,'' ``Sodium,'' ``Total
Carbohydrate,'' and ``Protein'') on the Nutrition Facts label are
required to be highlighted in bold or extra bold type or other
highlighting (Sec. 101.9(d)(1)(iv)). We have tentatively concluded,
based on design considerations of highlighting information in Bold type
(Ref. 167) would help differentiate the name of the nutrient from its
absolute amount, that all of the other nutrients listed on the
Nutrition Facts label, including those that are indented and the
vitamins and minerals, should also be highlighted in order to set them
apart from other information that appears in the Nutrition Facts label.
The key nutrients that are not indented above would still be
highlighted in a font that is bolder than the indented nutrients, so
the overall style of the Nutrition Facts label will not change.
Accordingly, we are proposing to amend Sec. 101.9(d)(1)(iv) to remove
the restriction that prohibits any other information on the label to be
highlighted, and to require that all voluntary nutrients specified in
Sec. 101.9(c), including the vitamins and minerals listed in Sec.
101.9(c)(8)(iv), appear in a type intermediate between bold and regular
type (if bold type is used) or between extra bold and regular type (if
extra bold type is used) on the Nutrition Facts label.
12. Addition of a Horizontal Line Beneath the Nutrition Facts Heading
The current label requires that the Nutrition Facts heading be set
in a type size larger than all other print size in the nutrition label
(Sec. 101.9(d)(2)) but does not require that this heading be set apart
from the rest of the label with a horizontal hairline rule, which is a
thin line. Horizontal lines are used throughout the Nutrition Facts
label as a key graphic element to divide space, direct the eye, and
give the label a unique and identifiable look. The repeated use of
horizontal lines helps develop the organization of the label,
strengthens the label's unity, accentuates width, and promotes
stability (Ref. 182). The addition of a hairline rule immediately below
the Nutrition Facts heading directs the reader's eye to the serving
size information, further emphasizes the information about servings,
and helps break the information into small chunks, thus making it
easier to process and remember the information (Ref. 167). Accordingly,
we have tentatively concluded that a 0.25 point hairline rule shall be
inserted directly beneath the Nutrition Fact heading on all label
formats, with the exception of the linear display for small packages.
We invite comment on this tentative conclusion.
13. Replacing ``Total Carbohydrate'' With ``Total Carbs''
Nutrition information declared on the Nutrition Facts label must be
presented using the nutrient names specified in Sec. 101.9(c) or Sec.
101.9(j)(13)(ii)(B). According to Sec. 101.9(c)(6), the nutrient name
used for listing information about the carbohydrate content of a
product is ``Total Carbohydrate.'' Certain abbreviations, as specified
in Sec. 101.9(j)(13)(ii)(B), may be used on the Nutrition Facts label
on packages that have a total surface area available to bear labeling
of 40 or less square inches. In addition, the term ``carb'' is commonly
used as a shortened term or acronym for ``carbohydrate'' (Ref. 183).
Although the current abbreviation for ``Total carbohydrate'' is ``Total
carb,'' we found that ``total carbs'' was extensively preferred over
``total carb'' as a Google search term during the past 15 years,
suggesting that ``carbs'' is the more commonly used term by the general
public (Ref. 184). As previously discussed, we are interested in
maximizing the amount of white space on the Nutrition Facts label and
in maintaining a simple format that minimizes clutter and enables the
public to readily observe and comprehend the nutrition information that
is presented. For the reasons set forth previously, we tentatively
conclude that using the term ``Total Carbs'' instead of ``Total
Carbohydrate'' would help achieve these objectives. Accordingly, we are
proposing to amend Sec. 101.9(c)(6) and Sec. 101.9(j)(13)(ii)(B) by
requiring that the total carbohydrate content in a serving be listed as
``Total Carbs'' instead of ``Total Carbohydrate'' or ``Total Carb'' and
that this listing be used on all label formats. We invite comment on
this tentative conclusion.
14. Alternative Visual Formats/Fonts
We considered the utility of alternative visual presentation
formats, in response to some comments that suggested using charts or
graphs to facilitate consumer understanding (Ref. 47). During the
development of the current label format, we examined alternative
graphic designs, including graphs, and determined that the current
format was optimal (Ref. 185). Since 1993, we reviewed two published
studies that explored alternative graphical formats (Refs. 172 and
186). These studies provided limited and

[[Page 11955]]

mixed evidence in support of the tested formats. For example, one study
(Ref. 186) did not investigate how graphical formats would perform when
individuals have to compare the healthfulness of more than one product
simultaneously. The other study (Ref. 172) demonstrated that when
participants used the test labels to compare two products, the
alternative graphical format was not unequivocally superior to a format
resembling the standard Nutrition Facts format, and indeed the
graphical display appeared to be inferior to the Nutrition Facts-type
format in supporting consumers' ability to calculate the number of
servings of a food that would provide the daily value of particular
nutrients. Therefore, in the absence of conclusive evidence to support
alternative graphical layouts, we are not proposing any changes to the
basic format of the Nutrition Facts label as specified in Sec.
101.9(d)(12). However, we invite comment on an alternative concept for
the Nutrition Facts label format that indicates ``quick facts'' (e.g.,
amount of total carbohydrate, fat and protein) about a product's
nutrient content first, and then explicitly points out nutrients to
``avoid too much'' of as well as nutrients to ``get enough'' of as a
way to categorize the nutrient declarations in the Nutrition Facts
label. We previously considered this concept of separating nutrients
out on the label and would like to reconsider it (Ref. 163). We request
comment on how this display may or may not convey the information in a
manner which enables the public to readily observe and comprehend such
information and whether separating and placing nutrients such as ``
``Total Fat and ``Saturated Fat'' under different headings would help
or hinder consumer's understanding of the Nutrition Facts label. We are
also interested in comments on what headings could be used and how to
categorize all of the nutrients.
Additionally, we are seeking comment on whether a specific type
style should be required for the Nutrition Facts label. Currently, we
specify in Sec. 101.9(d)(1)(ii)(A) that the type style should be a
``single easy-to-read type style'' but no specific type style is
required. However, in Sec. 101.9(d)(1) we urge that certain type
styles (i.e., Helvetica Black, Helvetica Regular, Franklin Gothic
Heavy) and other graphic design features be used, as described in
appendix B to title 21, part 101, of the Code of Federal Regulations.
We request comment on whether a specific font should be required to
ensure the readability of the Nutrition Facts label.
[GRAPHIC] [TIFF OMITTED] TP03MR14.002

N. Compliance

Section 101.9(g) provides information about how we determine
compliance with our nutrition labeling requirements, including the
methods of analysis used to determine compliance, reasonable excesses
and deficiencies of nutrients, and acceptable levels of variance from
declared values. Based on the proposed changes to other sections of
Sec. 101.9 (discussed in sections II.A. to II.M.) and taking into
account comments in response to the 2007 ANPRM, we are proposing
several changes to Sec. 101.9(g), which we discuss in this document.
1. Level of Variance Allowed for the Label Declaration of Specific
Nutrients
Section 101.9(g)(5) establishes that a food with a label
declaration of calories, sugars, total fat, saturated fat, trans fat,
cholesterol, or sodium shall be deemed to be misbranded under section
403(a) of the FD&C Act if the nutrient content of the composite is
greater than 20 percent in excess of the value for that nutrient
declared on the label. In addition, no regulatory action will be based
on a determination of a nutrient value that falls above this level by a
factor less than the variability generally recognized for the
analytical method used in that food at the level involved.
One comment to the 2007 ANPRM asked us to reevaluate the level of
variance permitted for nutrient content declarations, particularly for
added nutrients of concern such as sodium, sugar, and fat. Expressing
concern that the current practice could result in the provision of
inaccurate and misleading information to consumers, the comment
recommended that if we are unable to reduce the amount of permitted
variability, we should, at a minimum, require food processors to
include a disclosure on the food label.
In determining the allowances for variability in Sec. 101.9(g), we
considered variability in the nutrient content of foods, analytical
variability inherent to test methods used to determine compliance, and
statistical probability (38 FR 2125 at 2128, January 19, 1973). In
addition, we evaluated compliance procedures and found them to be
statistically sound and adequate. The comment provided no information
to support a change to the current level of variance or the use of a
disclosure statement in this context.
Therefore, we are not proposing to change the level of variance
allowed in Sec. 101.9(g)(5) in response to the comment.
2. Methods Used To Determine Compliance
Under Sec. 101.9(g)(2), a composite of 12 subsamples, each taken
from 12 different randomly chosen shipping cases are analyzed by
appropriate methods as given in the ``Official Methods of Analysis of
the AOAC International,'' 15th Ed. (1990) to determine compliance with
the requirements in Sec. 101.9, unless a particular method of analysis
is specified in Sec. 101.9(c). If no AOAC method is available or
appropriate, we use other reliable and appropriate analytical
procedures (see Sec. 101.9(g)(2)). The current edition (19th Ed.) of
the ``Official Methods of Analysis of the AOAC International'' includes
many updates to the 15th Edition.
When we issued Sec. 101.9(g) related to compliance with nutrition
labeling requirements, the most current version of the AOAC methods was
its 15th edition and, therefore, we identified the 15th edition in our
regulation. Newer and better methods of analysis have

[[Page 11956]]

been subsequently validated and recognized as ``official'' methods in
the current 19th edition (2012) of the Official Methods of Analysis of
the AOAC International. Accordingly, we are proposing to amend Sec.
101.9(g)(2) by removing ``15th Ed. (1990)'' and adding in its place
``19th Ed. (2012)'' to specify that we will analyze composites ``by
appropriate methods as given in the ``Official Methods of Analysis of
the AOAC International,'' 19th Ed. (2012).'' If a newer edition of the
Official Methods of the AOAC International is published before issuance
of a final rule, and assuming that we issue a final rule, we intend to
finalize this rule with the newer edition, as appropriate, provided
there are no substantive changes in the newer edition requiring
additional comment.
3. Records Requirements
Current Sec. 101.9(g)(2) sets forth requirements for composite
sampling and analysis to determine compliance with labeling
declarations. Specifically, unless a specific analytical method is
identified by regulation, composites are analyzed by the appropriate
AOAC method (15th Edition) or, if no AOAC method is available or
appropriate, by other reliable and appropriate analytical procedures.
For certain nutrients subject to this proposed rule, however, there is
no AOAC official method of analysis or other reliable or appropriate
analytical procedure that is available for us to verify the amount of
the declared nutrient on the Nutrition Facts label and ensure that the
declared nutrient amount is truthful, accurate and complies with all
applicable labeling requirements, including the requirements in Sec.
101.9(g). Specifically, there is no suitable analytical procedure
available to measure the quantity of: (1) Added sugars (when a food
product contains both naturally occurring sugars and added sugars and
for specific foods containing added sugars, alone or in combination
with naturally occurring sugars, where the added sugars are subject to
fermentation); (2) dietary fiber (when a food product contains both
non-digestible carbohydrate(s) that meets the proposed definition of
dietary fiber and non-digestible carbohydrate(s) that does not meet the
definition of dietary fiber); (3) soluble fiber (when a mixture of
soluble fiber and added non-digestible carbohydrate(s) that does not
meet the definition of dietary fiber are present in a food); (4)
insoluble fiber (when a mixture of insoluble fiber and non-digestible
carbohydrate(s) that does not meet the definition of dietary fiber are
present in a food); (5) vitamin E (when a food product contains both
RRR-[alpha]-tocopherol and all rac-[alpha]-tocopherol acetate); and (6)
folate (when a food product contains both folate and folic acid). As
discussed in sections II.D.3. (added sugars), II.D.5.a. (dietary
fiber), II.D.5.b. (soluble and insoluble fiber), II.J.2. (folate), and
II.J.3. (vitamin E)
Under current Sec. 101.9(g)(9), FDA may permit the use of an
alternative means of compliance or additional exemptions when it is not
technologically feasible, or some other circumstance makes it
impracticable, for firms to comply with the requirements of Sec.
101.9. In such a case, under Sec. 101.9(g)(9), firms must submit a
request in writing to FDA for the use of an alternative means of
compliance or for a labeling exemption. We are proposing an alternative
approach for assessing compliance of the declared amount of each of the
nutrients identified previously under the circumstances we describe,
given the nature of the information necessary to determine compliance
and the number of foods potentially affected, because there is no
suitable analytical method available to measure the quantity of each
such nutrient as declared on the label or in labeling. We are proposing
to require the manufacturer to make and keep records, identified in
proposed Sec. 101.9(g)(10), that are necessary to verify the declared
amount of each of these nutrients on the Nutrition Facts label. In
proposed Sec. 101.9(g)(10) and (g)(11), we are proposing that
manufacturers must make and keep written records, as specified for each
of the nutrients and under the circumstances described in proposed
Sec. 101.9(g)(10)(i-vii), that are necessary to verify the declared
amount. We tentatively conclude that the records will provide the
manufacturer and FDA with the necessary means to determine compliance
with Sec. 101.9(g) requirements related to nutrient declaration.
The manufacturer is in the best position to know which of its
records provide the documentation required under the circumstances
described previously for us to determine compliance. Some of the
required records may appropriately include one or more of the
following: Analyses of databases, recipes or formulations, or batch
records. We recognize that the nutrient profile of processed foods that
have added sugars, dietary fiber, soluble fiber, insoluble fiber,
vitamin E, or folate/folic acid can vary depending on the recipe or
formulation, the suppliers of ingredients, etc. Therefore, the amount
of nutrients in a food may change if a manufacturer changes ingredient
suppliers or changes a recipe. In order to verify the nutrient
composition of a packaged food, the manufacturer would need to ensure
that the records it provides to us to verify the declared amount of
each of these nutrients, under the circumstances described,
substantiate the nutrient composition of the specific food and, as
appropriate, can distinguish among the same or similar product the
manufacturer has in the marketplace that may contain differing amounts
of the declared nutrient. For example, the manufacturer may have to
distinguish among different fruit juice products with different amounts
of added sugars or the same fruit juice product with different
formulations. Most manufacturers should already have the type of
records needed to validate the declared amount of each of these
nutrients. The records requirements provide flexibility in what records
the manufacturer makes available to us to verify the declared amount of
these nutrients for a particular marketed product. In the absence of an
accurate and reliable analytical method for quantifying the amount of
these nutrients for nutrition labeling under the circumstances
described, only the manufacturer will have the information required to
determine the accuracy of the declared amount. The information
contained in manufacturers' records is an accurate and practical method
for assuring that the nutrient declarations comply with section 403(q)
of the FD&C Act. Under section 403(q) of the FD&C Act, a food must
bear, in its label or labeling, the amount of the nutrient the food
contains. The purpose of providing the nutritional value of the food is
to assist consumers in maintaining health dietary practices. Moreover,
the nutrient declaration must be truthful and not misleading under
sections 403(a)(1) and 201(n) of the FD&C Act.
Under section 701(a) of the FD&C Act, we may issue regulations for
the efficient enforcement of the FD&C Act in order to ``effectuate a
congressional objective expressed elsewhere in the Act'' (Association
of American Physicians and Surgeons, Inc. v FDA, 226 F. Supp. 2d 204
(D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v FDA, 484 F. Supp. 1179,
1183 (D. Del. 1980). The proposed record requirements for these
nutrients, under the circumstances described, are designed to ensure
that the nutrient declarations are accurate, truthful and not
misleading, based on information known only to the manufacturer, and to
facilitate efficient and effective action to enforce the requirements
when necessary. Our authority to establish records

[[Page 11957]]

requirements has been upheld under other provisions of the FD&C Act
where we have found such records to be necessary (National
Confectioners Assoc. v. Califano, 569 F.2d 690, 693-94 (D.C. Cir.
1978). The records we propose to require are only for foods for which
an AOAC or other reliable and appropriate analytical method is not
available. They allow us to verify the declared amount of each of these
nutrients and that such amount is truthful and not misleading. Thus,
the proposed records requirements assist in the efficient enforcement
of the FD&C Act.
The authority granted to us under sections 701(a), 403(q),
403(a)(1) and 201(n) of the FD&C Act not only includes authority to
establish records requirements, but also includes access to such
records. Without such authority, the nutrient declarations for these
specific nutrients that we have determined are necessary to assist
consumers in maintaining healthy dietary practices under section
403(q)(2)(A) of the FD&C Act are, practically speaking, not
enforceable. Without access to such records, we would not know whether
the amount declared on the label or in the labeling of each of these
nutrients, under the circumstances described, is truthful and not
misleading under sections 403(a)(1) and 201(n). The introduction or
delivery for introduction into interstate commerce of a misbranded food
is a prohibited act under section 301(a) of the FD&C Act. Thus, in
order for us to determine whether the food is misbranded and the
manufacturer has committed a prohibited act, we must have access to the
manufacturer's records that we are requiring be kept under sections
403(q), 403(a) and 201(n) of the FD&C Act.
We anticipate that manufacturers may have concerns about the
confidentiality of the information inspected by us under this proposal.
We would protect confidential information from disclosure, consistent
with applicable statutes and regulations, including 5 U.S.C. 552(b)(4),
18 U.S.C. 1905, and 21 CFR part 20.
Finally, it is necessary for the aforementioned records to be made
available for review and copying while the product is available for
purchase in the marketplace. The shelf life of packaged foods varies by
product. Due to the significant number of packaged food products in the
marketplace, there could be a wide variety of shelf lives among
packaged foods. Some foods are subject to specific records
requirements, such as dietary supplements (Sec. 111.605 (21 CFR
111.605)), low acid canned foods (21 CFR 113.100), acidified foods (21
CFR 114.100), fruit juice (Sec. 111.120), and seafood (Sec. 111.123).
Therefore, the record retention period we propose to require to verify
certain nutrient declarations may include records that manufacturers
are required to make and keep for the same or longer periods under
other requirements. The proposed record requirements for purposes of
verifying nutrient declarations of such nutrients are separate and
distinct from other record requirements. Generally, manufacturers are
required to make and keep records for a minimum of 2 years (21 CFR
1.360(d)), which the Agency considers a reasonable period of time for
most foods to be available for purchase in the marketplace.
Thus, we are proposing to require that manufacturers must make and
keep written records to verify the declaration of: (1) The amount of
added sugars when both naturally occurring and added sugars are present
in a food (in Sec. 101.9(c)(6)(iii)); (2) the amount of added non-
digestible carbohydrate(s) that does not meet the proposed definition
of dietary fiber when the dietary fiber present in a food is a mixture
of non-digestible carbohydrates that do and that do not meet the
definition of dietary fiber (in Sec. 101.9(c)(6)(i)); (3) the amount
of added soluble non-digestible carbohydrate(s) that does not meet the
proposed definition of dietary fiber when the soluble dietary fiber
present in a food is a mixture of soluble non-digestible carbohydrates
that do and that do not meet the definition of dietary fiber (in Sec.
101.9(c)(6)(i)(A)); (4) the amount of added insoluble non-digestible
carbohydrate(s) that do not meet the proposed definition of dietary
fiber when the insoluble dietary fiber present in a food is a mixture
of insoluble non-digestible carbohydrates that do and that do not meet
the definition of dietary fiber (in Sec. 101.9(c)(6)(i)(B)); (5) the
amount of all rac-[alpha]-tocopherol acetate added to the food and RRR-
[alpha]-tocopherol in the finished food when a mixture of both forms of
vitamin E are present in a food (in Sec. 101.9(g)(10)(i)); and (6) and
the amount of folic acid added to the food and the amount of folate in
the finished food when a mixture of both forms are present in a food
(in Sec. 101.9(g)(10)(ii)). We are also proposing, in Sec.
101.9(g)(11), that such records must be kept for a period of 2 years
after introduction or delivery for introduction of the food into
interstate commerce. In addition, we are proposing to require that such
records must be provided upon request, during an inspection, for
official review and photocopying or other means of reproduction, and
that records required may be retained either as original records, true
copies (such as photocopies, pictures scanned copies, microfilm,
microfiche, or other accurate reproductions of the original records) or
electronic records. Where reduction techniques, such as microfilming
are used, suitable reader and photocopying equipment would need to be
readily available. All electronic records maintained under Sec. 101.9
would need to comply with part 11 of this chapter (Sec. 101.9(g)(11)).
We note that Part 11 would apply to any electronic records that are
maintained to comply with the proposed requirements. We advise that the
use of electronic records is voluntary and thus, a paper record system
could be used to comply with these proposed recordkeeping requirements.
The proposed requirements for electronic records extend to electronic
signatures. We issued final guidance for industry on this topic. The
guidance, entitled ``Part 11, Electronic Records; Electronic Signatures
Scope and Application,'' sets out the Agency's enforcement policies
with respect to certain aspects of part 11. The guidance is available
at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm.
This guidance would apply to any electronic record, including
electronic signatures, established or maintained to meet a proposed
requirement in this rule, if finalized as proposed. We request comment
on the proposed requirements for the types of records that must be made
and kept and the length of time that the records must be kept.
4. Inclusion of Potassium as a Mineral
Potassium is specified as a Class I and Class II nutrient in Sec.
101.9(g)(4)(i) and (g)(4)(ii), respectively. This nutrient is the only
vitamin or mineral that is specifically listed under the description of
both Class I and Class II nutrients. Potassium is a mineral for which
an RDI is being proposed (Sec. 101.9(c)(8)(iv)) and the absolute
amount would be required to be declared along with a percent DV on the
Nutrition Facts label. We tentatively conclude that there is no need to
separately list potassium under the description of Class I and Class II
nutrients because it is encompassed within the category, mineral.
Therefore, we are proposing to remove specific inclusion of the term
``potassium'' within Sec. 101.9(g)(4), (g)(4)(i), (g)(4)(ii), and
(g)(6) such that it would be covered under ``mineral'' and any listing
of potassium on the Nutrition Facts label would have to meet the
specific compliance requirements for minerals

[[Page 11958]]

under Sec. 101.9(g)(4), (g)(4)(i), (g)(4)(ii), and (g)(6).
5. Requirements for Other Carbohydrate, Soluble and Insoluble Fiber,
Added Sugars, and Sugar Alcohols
The labeling requirements for Class I and Class II nutrients are
provided in section Sec. 101.9(g)(4). For the reasons discussed in
section II.D.6., we are proposing to revise Sec. 101.9(c)(6)(iv) to
remove the provision for voluntary declaration of ``Other
carbohydrate.'' Accordingly, we are proposing to remove compliance
requirements related to ``Other carbohydrate'' in Sec. 101.9(g)(4) and
(g)(6).
Dietary fiber is included as both a Class I and Class II nutrient
because food products may contain only non-digestible carbohydrates
that meet the definition of dietary fiber and that may be naturally
occurring or that may be added to fortified or fabricated foods. The
same is true for soluble and insoluble fiber, yet these nutrients are
not specifically listed as Class I or Class II nutrients. Therefore, we
are proposing to include soluble and insoluble fiber in Sec.
101.9(g)(4) as both Class I and Class II nutrients.
Section Sec. 101.9(g)(5) specifies that a food with a label
declaration of calories, sugars, total fat, saturated fat, trans fat,
cholesterol or sodium shall be deemed to be misbranded under section
403(a) of the FD&C Act if the nutrient content of the composite is
greater than 20 percent in excess of the value for that nutrient
declared on the label. The nutrients listed in this section can have a
negative impact on health in the general U.S. population if consumed in
excess and/or there are current dietary recommendations to reduce the
consumption of these nutrients. Therefore, we are ensuring in Sec.
101.9(g)(5) that foods do not contain excessive amounts of these
nutrients of which the consumer is not aware. Current dietary
recommendations acknowledge that Americans consume excess amounts of
added sugars and encourage reducing intake of calories from added
sugars. As discussed in section II.D.3., added sugars, like naturally
occurring sugars, can contribute to dental caries. As with the other
nutrients listed in Sec. 101.9(g)(5), we have an interest in ensuring
that foods do not contain excessive amounts of added sugars that are
not declared on the label. Therefore, we are proposing to include added
sugars in Sec. 101.9(g)(5). In some food products, the only source of
sugars may be added sugars. In such cases, an analytical method could
be used to determine the amount of added sugars in the food product and
the permitted analytical variability would be applicable. Accordingly,
we are proposing to amend Sec. 101.9(g)(5) to include ``added sugars
(when the only source of sugars in the food is added sugars)'' among
the list of nutrients.
In Sec. 101.9(g)(6), reasonable excesses of certain nutrients over
labeled amounts are acceptable within current good manufacturing
practice. In addition, reasonable deficiencies of certain other
nutrients under labeled amounts are acceptable within current good
manufacturing practice. Consistent with this approach, we are proposing
to allow, in Sec. 101.9(g)(6), reasonable excesses over the labeled
amount of soluble and insoluble fiber and sugar alcohols when they are
acceptable within current good manufacturing practice, and reasonable
deficiencies under labeled amounts of added sugars when they are
acceptable within current good manufacturing practice. As with other
nutrients added to fortified or fabricated foods, we expect that when a
food product contains added sugars, when all of the dietary fiber (both
soluble and insoluble) is added non-digestible carbohydrate that meets
the definition of dietary fiber, when all of the vitamin E is all rac-
[alpha]-tocopherol acetate, and when only folic acid is present in a
food, the declared amount must be a least equal to the amount of the
nutrient added to the food.
In summary, we are proposing the following changes related to
compliance: (1) Amend Sec. 101.9(g)(2) to cite the 19th edition of the
Official Methods of Analysis of the AOAC International as the reference
for appropriate methods used to determine compliance with amounts of
nutrients declared on the Nutrition Facts label; (2) amend Sec.
101.9(c)(6)(i), (c)(6)(iii), (g)(10), (g)(10)(i), and (g)(10)(ii) to
establish general recordkeeping requirements when records are necessary
to verify information related to dietary fiber, added sugars, folate,
and vitamin E provided on the label; (3) remove specific inclusion of
the term ``potassium'' within Sec. 101.9(g)(4), (g)(4)(i), (g)(4)(ii),
and (g)(6) such that potassium would covered under ``mineral'' and any
listing of potassium on the Nutrition Facts label would meet the
specific compliance requirements for minerals under Sec. 101.9(g)(4),
(g)(4)(i), (g)(4)(ii), and (g)(6); (4) when all of dietary fiber in a
food product meets the proposed definition of dietary fiber, include
soluble and insoluble fiber as both Class I and Class II nutrients
under Sec. 101.9(g)(4); (5) include added sugars within Sec.
101.9(g)(5) such that the label declaration of added sugars will be
deemed misbranded under section 403(a) of the FD&C Act if the nutrient
composite is greater than 20 percent in excess of the added sugars
value declared on the label, and within Sec. 101.9(g)(6) such that
reasonable deficiencies of added sugars would be permitted; (6) include
soluble and insoluble fiber and sugar alcohols within Sec. 101.9(g)(6)
such that reasonable excesses of these nutrients would be permitted;
and (7) consistent with the tentative conclusion in section II.D.6.,
remove references to ``Other carbohydrates'' in Sec. 101.9(g).

O. Technical Amendments

1. Changing the Name of the Program Office
Since publication of the regulations for nutrition labeling, the
name of the office at the Center for Food Safety and Applied Nutrition
that is responsible for developing regulations and answering questions
related to nutrition labeling as well as for maintaining some of the
references discussed throughout Sec. 101.9 has changed. The Office of
Nutritional Products, Labeling and Dietary Supplements is now called
the Office of Nutrition, Labeling and Dietary Supplements. We are
proposing to update the name of the office throughout Sec. 101.9.
2. Changing the Publication Date of Report Incorporated by Reference
Section Sec. 101.9(c)(7)(ii) provides that the protein
digestibility-corrected amino acid score ``shall be determined by
methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein Quality
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein
Quality Evaluation,'' Rome, 1990, except that when official AOAC
procedures described in section (c)(7) of this paragraph require a
specific food factor other than 6.25, that specific factor shall be
used.'' We incorporated the ``Report of the Joint FAO/WHO Expert
Consultation on Protein Quality Evaluation'' by reference in Sec.
101.9(c)(7)(ii). Although the referenced report was written in 1989, it
was published in 1991. We are, therefore, proposing to change the
publication date of the report that is incorporated by reference from
1990 to 1991.
3. Plain Language Edits
On October 13, 2010, the President signed the Plain Writing Act of
2010 requiring that Federal Agencies use ``clear Government
communication that the public can understand and use.'' On January 18,
2011, the President issued an Executive Order (E.O. 13563 (75 FR
3821)--Improving Regulation and

[[Page 11959]]

Regulatory Review) that requires that the government must ensure that
regulations are accessible, consistent, written in plain language, and
easy to understand. In an effort to make the requirements of Sec.
101.9 easier to understand, we are proposing to make editorial changes
that do not change the meaning or intent of the language in Sec.
101.9(g)(3)(ii); (g)(4)(i); (g)(4)(ii); and (g)(5).
In Sec. 101.9(g)(3)(ii), we are revising the current language to
clarify that when a nutrient or nutrients are not naturally occurring
(exogenous) in an ingredient that is added to a food, the total amount
of such nutrient(s) in the final food product is subject to Class I
requirements rather than Class II requirements. It is not explicitly
stated in the current regulation that such a nutrient would be subject
to Class I requirements.
In Sec. 101.9(g)(4)(i) and (g)(4)(ii), the definitions include a
list of vitamins and minerals that are being defined as Class I or
Class II vitamins and minerals followed by compliance requirements for
those nutrients. This differs from the definition provided in Sec.
101.9(g)(3)(i) and (g)(3)(ii) in that the definitions provided in Sec.
101.9(g)(3)(i) and (g)(3)(ii) are about whether a nutrient is added or
naturally occurring. We are proposing to remove ``Class I'' and ``Class
II'' from the beginning of sections Sec. 101.9(g)(4)(i) and (g)(4)(ii)
and to state instead that when the list of nutrients provided in those
sections meets the definition of a Class I or Class II nutrient
provided for in Sec. 101.9(g)(3)(i) and (g)(3)(ii), the declaration of
those nutrients must meet certain requirements. The proposed change is
being made to prevent confusion by having two different definitions of
a ``Class I'' and ``Class II'' nutrient for compliance with nutrition
labeling requirements.
In Sec. 101.9(g)(5), we are proposing to remove the words
``Provided, That''. These words do not provide further clarification
and they add additional complexity to the section that is not
necessary.

III. Proposed Effective and Compliance Dates

We intend that any final rule resulting from this rulemaking, as
well as any final rule resulting from the proposed rule entitled ``Food
Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At
One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts Customarily Consumed; Serving
Size for Breath Mints; and Technical Amendments'' become effective 60
days after the date of the final rule's publication in the Federal
Register with a compliance date 2 years after the effective date. We
recognize that it may take industry time to analyze products for which
there may be new mandatory nutrient declarations, make any required
changes to the Nutrition Facts label (which may be coordinated with
other planned label changes), review and update their records of
product labels, and print new labels. A compliance date that is 2 years
after the effective date is intended to provide industry time to revise
labeling to come into compliance with the new labeling requirements
while balancing the need for consumers to have the information in a
timely manner. We invite comment on the proposed compliance date.

IV. Analysis of Impacts

We have examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) and the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
Executive Orders 12866 and 13563 direct us to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). We are
publishing two proposed rules on nutrition labeling in the Federal
Register. We have developed one comprehensive Preliminary Regulatory
Impact Analysis (PRIA) (Ref. 187) that presents the benefits and costs
of the two proposed nutrition labeling rules taken together; the PRIA
is available at https://www.regulations.gov (Docket No. FDA-2012-N-
1210). The full economic impact analyses of FDA regulations are no
longer (as of April 2012) published in the Federal Register but are
submitted to the docket and are available on this site. We believe that
the cumulative impact of the proposed rules on nutrition labeling,
taken as a whole, represent a significant regulatory action as defined
by Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Additional costs per entity of the proposed rule are
small, but not negligible, and as a result we conclude that the
proposed rules on nutrition labeling, taken as a whole, would have a
significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that we prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. We have determined that
the proposed rules on nutrition labeling, taken as a whole, meet this
threshold.
The analysis that we have performed to examine the impacts of the
proposed rules under Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the PRA (see section V.) are included
in the PRIA (Ref. 187) and are available at https://www.regulations.gov
(Docket No. FDA-2012-N-1210). We invite comment on the PRIA.

V. Paperwork Reduction Act of 1995

This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the PRA. A description of these provisions is given in the PRIA
(Ref. 187) available at https://www.regulations.gov (Docket No. FDA-
2012-N-1210) with an estimate of the annual reporting, recordkeeping,
and third-party disclosure burden. Included in the burden estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
To ensure that comments on information collection are received,

[[Page 11960]]

OMB recommends that written comments be faxed to the Office of
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:
202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments
should be identified with the title ``Record Retention, Reporting, and
Third-Party Disclosure Requirements for the Declaration of Added
Sugars, Dietary Fiber, Soluble Fiber, Insoluble Fiber, Vitamin E, and
Folate/Folic Acid.''
In compliance with the PRA, we have submitted the information
collection provisions of this proposed rule to OMB for review. These
requirements will not be effective until we obtain OMB approval. We
will publish a notice concerning OMB approval of these requirements in
the Federal Register.

VI. Analysis of Environmental Impact

We have carefully considered the potential environmental effects of
this action. We have concluded that the action will not have a
significant impact on the human environment, and that an environmental
impact statement is not required (Refs. 188 and 189). Our finding of no
significant impact and the evidence supporting that finding, contained
in an environmental assessment, may be seen in the Division of Dockets
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through
Friday.

VII. Federalism

We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive Order requires Agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.''
Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express
preemption provision. Section 403A(a) of the FD&C Act provides that:
``* * * no State or political subdivision of a State may directly or
indirectly establish under any authority or continue in effect as to
any food in interstate commerce--(4) any requirement for nutrition
labeling of food that is not identical to the requirement of section
403(q) * * *.''
The express preemption provision of section 403A(a) of the FD&C Act
does not preempt any State or local requirement respecting a statement
in the labeling of food that provides for a warning concerning the
safety of the food or component of the food (section 6(c)(2) of the
Nutrition Labeling and Education Act of 1990, Pub. L. 101-535, 104
Stat. 2353, 2364 (1990)). If this proposed rule is made final, the
final rule would create requirements that fall within the scope of
section 403A(a) of the FD&C Act.

VIII. Comments

Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
We invite comment on all aspects of the proposed rule, including
the need for, and appropriateness of, the various provisions proposed
in this rule and our accompanying rationale. Specifically:
(1) We invite comment on our use of the most recent consensus
reports and whether the information and data on which FDA relies from
such reports for proposed changes is consistent with current scientific
information, the factors for considering mandatory and voluntary
declaration of non-statutory nutrients, and whether there is an
appropriate alternative analysis to application of these factors
regarding (a) no longer permitting mandatory declaration (i.e.,
vitamins A and C); (b) requiring the declaration of a nutrient that is
currently voluntary (e.g., vitamin D), and; (c) continuing the
voluntary labeling of macronutrients (e.g., monounsaturated and
polyunsaturated fats);
(2) We invite comment on the tentative conclusion to no longer
permit the declaration of ``Calories from fat'' on the Nutrition Facts
label and on the tentative conclusion not to establish a DRV for
calories and include a percent DV for the declaration of calories,
which are discussed in section II.A;
(3) In section II.B., we addressed various issues related to the
declaration of total fat and related nutrients. We invite comment on
the proposed definition of fatty acids, as well as on our tentative
conclusion that acetic, propionic, and butyric acids should not be
excluded from the definition of total fat;
(4) We invite comment on various issues related to the declaration
of carbohydrates and related nutrients, which are discussed in section
II.D.: (a) With respect to added sugars, we request comments on our
tentative conclusions and proposed provisions for mandatory declaration
of added sugars, the placement of this information as double indented
line below total sugars, and means to verify compliance. We also invite
comment, including the submission of available research, on whether
calories from added sugars should be declared on the Nutrition Facts
label in lieu of a gram declaration of added sugars to aid consumers in
maintaining healthy dietary practices. We also invite comment on
products that are subjected to non-enzymatic browning reactions and
fermentation, and the amount of variability that occurs among various
types of products where added sugars are transformed into other
compounds as a result of chemical reactions during food processing; (b)
with respect to dietary fiber, we invite comment on the proposed
definition of dietary fiber and retaining the term ``dietary fiber.''
We invite comment, including the submission of information on consumer
understanding of the term ``dietary fiber'' relative to other relevant
terms; and (c) we are proposing to eliminate the provision for
voluntary declaration of ``Other carbohydrate'' on the Nutrition Facts
label, and tentatively conclude that the proposed amendment is unlikely
to have a significant impact on industry or consumers. We invite
comment on this issue, including the submission of any other data or
factual information that we should consider in making a final
determination.
(5) We invite comment on our tentative conclusions related to
sodium discussed in section II.G., including the proposed DRV. In
particular, we invite comment on: (a) The rationale for the proposed
DRV of 2,300 for sodium; (b) whether a RDI of 1,500j mg would be more
appropriate and why, and; (c) alternative approaches for selecting a DV
for sodium and their public health basis for these approaches. We are
also interested in comment, including data and factual information on
consumer understanding, interpretation, and use of the percent DV of
sodium declared on food labels, and the understanding and potential
influences of a DV that reflects an RDI based on an AI (an intake level
to not consume less of), instead of a DRV based on a UL (an intake
level not to exceed);
(6) In section II.H., we are proposing to: (a) Retain mandatory
declaration of calcium and iron; (b) provide for voluntary declaration
of vitamins A and C; (c) require the declaration of potassium and
vitamin D; and (d) retain voluntary declaration of several other

[[Page 11961]]

vitamins and minerals. We are also proposing to require that all
vitamins and minerals declared on the Nutrition Facts label must
include their quantitative amounts (in addition to the requirements for
corresponding percent DV declaration). We invite comment on these
tentative conclusions, including the appropriate placement of the
quantitative amounts of nutrients on the Nutrition Facts label,
including data and other available information on the impact of
mandatory labeling of vitamins and minerals on food fortification. We
invite comment on the proposed mandatory declaration of vitamin D,
potassium, calcium and iron on the label, including how we consider the
public health significance of each. We also invite comment on whether
the presence of these nutrients presents concerns related to label
space or the need for consumer education. We also invite comment on
whether the presence of these nutrients presents concerns related to
label space or the need for consumer education.
(7) In section II.I., we are proposing to use population-coverage
RDAs, when available, or AIs as the basis for establishing RDIs. We
invite comment on our analysis and rationale, including available data
and information related to our analysis, and any available data on what
role, if any, the basis of the DV (EAR or RDA) has on consumption of
nutrients above the UL and in discretionary fortification of foods; we
request comment on lowering the RDI of B12 to 2.4 [mu]g.
(8) In section II.I.6, whether quantitative amounts for nutrients
with RDI values that contain three or four digits should be rounded,
what the rounding increments should be, and data to support suggested
rounding increments for such vitamins and minerals.
(9) We invite comment on issues related to units of measure,
nomenclature, and analytical methods, which are discussed in section
II.J.;
(10) We invite comment on issues related to nutrition labeling for
foods represented or purported to be specifically for infants 7 through
12 months of age, children 1 through 3 years of age, and pregnant and
lactating women, which are addressed in section II.K., including (a)
any available relevant empirical research as to whether the proposed
declaration of saturated fat and cholesterol for infants and children 1
through 3 years of age is likely to be confusing to consumers or
otherwise result in restriction of fat intakes among these
subpopulations; (b) how consumers would understand and use the
information on amounts of saturated fat and cholesterol in the
nutrition labeling of foods for infants and young children and whether
there is a need for an explanatory footnote to accompany such proposed
mandatory declaration; (c) our tentative conclusion that declaration of
added sugars should be mandatory on foods represented or purported to
be specifically for infants 7 through 12 months of age, children 1
through 3 years of age, and pregnant and lactating women; and (d)
adequacy of the proposed RDIs for vitamins and minerals for older
infants and children 1 through 3 years of age.
(11) We invite comment, including available data and other
information on the reformulation of dietary supplement products that
may result from proposed changes to the DVs, as well as information on
the potential consequences of such reformulations;
(12) We invite comment on whether we should consider changes to the
footnote statement ``Percent Daily Values are based on a 2,000 calorie
diet'' used on dietary supplement labels to be consistent with any
changes to the footnote statement in the Nutrition Facts label.
(13) We invite comment on (a) including the use of an alternative
format design or requiring the use of a specific font; (b) our
tentative conclusion that emphasizing both the number of calories per
serving and the number of servings per container will serve as an
anchor to highlight this information and grab the reader's attention,
and therefore will assist consumers to effectively use this information
in the Nutrition Facts label; (c) whether any of the changes that are
being proposed to the Nutrition Facts label should also be required for
certain products with Supplement Facts labels that list calories and/or
other macronutrients, and if so, under what conditions and for which
dietary supplement products should such labeling be required; (d) our
tentative view that there is no need to propose changing the order of
how serving size and servings per container are listed on the
Supplement Facts label, or to make amendments in the type size or
capitalization corresponding to our proposed changes for this
information on the Nutrition Facts labels; (e) our tentative conclusion
that, based on design considerations, the label statement for ``Serving
size'' in both household units and gram amounts should be right-
justified on the same line that ``Serving size'' is listed; (f) our
tentative conclusion that changing the ``Amount Per Serving'' statement
to ``Amount per------'' with the blank filled in with the actual
serving size would assist consumers in using the information and may
lessen the time and effort needed to locate the target information and
improve the accuracy of judgments about the calorie amounts and
nutrient contents of packaged food products; (g) the double indented
placement of added sugars below total sugars and invite available
research data formation; (h) our tentative view that increasing the
type size, bolding key elements of the footnote (space permitting), and
adding a bar clearly separating it from the micronutrient information
directly above will assist consumers in using the information; (i) our
tentative view on the need for a footnote statement for enhancing
consumers' use and understanding of the percent DV; (j) using data
provided consumer research we plan to conduct during this rulemaking
that will test consumer reactions to a definition of percent DV, a
succinct statement on calories, and several statements related to the
``5/20 rule''; (k) whether or not this calorie conversion information
should continue to be optional on the Nutrition Facts label, and
whether there are any data suggesting that consumers do or do not use
this information; (l) alternative terms that may be more readily
understandable than Daily Value, such as Daily Guide or Daily Need; (m)
whether the word ``percent'' (or the % symbol) needs to precede
whatever term is used in the column heading where the percent DVs are
listed; (n) whether there is a need to include vertical lines that are
similarly placed on Supplement Facts labels for multiple vitamins in
packets (Sec. 101.36(e)(11)(iii)) and for dietary supplements that
list ``per serving'' and ``per day'' information (Sec.
101.36(e)(11)(viii)); (o) the appropriate placement of percent DVs in
the labeling of foods for infants 7 through 12 months, children 1
through 3 years of age, and pregnant and lactating women; (p) our
tentative conclusion to insert a 0.25 point hairline rule directly
beneath the Nutrition Fact heading on all label formats, with the
exception of the linear display for small packages; (q) listing the
total carbohydrate content in a serving as ``Total Carbs'' instead of
``Total Carbohydrate'' or ``Total Carb'' and its listing used on all
label formats; (r) an alternative concept for the Nutrition Facts label
format that indicates ``quick facts'' about a product's nutrient
content and explicitly points out nutrients to ``avoid too much'' of as
well as nutrients to ``get enough'' of, and; (s) whether a specific
font should be required for the Nutrition

[[Page 11962]]

Facts label. We request comment on how this display may or may not
convey the information in a manner which enables the public to readily
observe and comprehend such information and whether separating and
placing nutrients such as ``Total Fat'' and ``Saturated Fat'' under
different headings would help or hinder consumer's understanding of the
Nutrition Facts label. We also are interested in comments on what
headings could be used and how to categorize all of the nutrients.

IX. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified all the Web site addresses in this reference section, but
we are not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)

1. U.S. Food and Drug Administration. ``Memorandum to the File:
Regulatory History Related to Nutrition Labeling for Proposed Rule
``Food Labeling: Revision of the Nutrition and Supplement Facts
Label'', 2014.
2. Centers for Disease Control and Prevention. (August 13, 2012)
``Chronic Diseases and Health Promotion''. Retrieved from https://www.cdc.gov/chronicdisease/overview/index.htm.
3. Lloyd-Jones, D., Adams, R.J., Brown, T.M., et al. ``Heart Disease
and Stroke Statistics--2010 Update: A Report From the American Heart
Association''. Circulation. 2010;121:e46-e215.
4. Centers for Disease Control and Prevention. (2011) ``National
Diabetes Fact Sheet, 2011''. Retrieved from https://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.
5. National Cancer Institute. (2011) ``Surveillance Epidemiology and
End Results (SEER) Stat Fact Sheets: All Sites''. Retrieved from
https://seer.cancer.gov/statfacts/html/all.html.
6. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. (2010) ``Dietary Guidelines for Americans, 2010'',
7th Ed., Washington DC: U.S. Government Printing Office. Retrieved
from https://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm.
7. Flegal, K.M., Carroll, M.D., Ogden, C.L., et al. ``Prevalence and
Trends in Obesity Among U.S. Adults, 1999-2008''. JAMA: the Journal
of the American Medical Association. 2010;303:235-241.
8. Ogden, C.L., Carroll, M.D., Curtin, L.R., et al. ``Prevalence of
High Body Mass Index in U.S. Children and Adolescents, 2007-2008''.
JAMA: the Journal of the American Medical Association. 2010;303:242-
249.
9. National Institutes of Health, National Heart Lung and Blood
Institute in cooperation with The National Institute of Diabetes and
Digestive and Kidney Diseases. (1998) ``Clinical Guidelines on the
Identification, Evaluation, and Treatment of Overweight and Obesity
in Adults: The Evidence Report; NIH Publication No. 98-4083''.
Retrieved from https://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf.
10. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Water, Potassium, Sodium, Chloride, and
Sulfate, Chapter 6: Sodium and Chloride'', Washington, DC: National
Academies Press; 2005. pp. 269-423.
11. U.S. Food and Drug Administration. ``Memorandum to the File:
Total Usual Intakes of Sodium for 4 Years and Older'', 2014.
12. Usual Sodium Intakes Compared With Current Dietary Guidelines--
United States, 2005-2008. MMWR Morbidity and Mortality Weekly
Report. 2011;60:1413-1417.
13. Institute of Medicine (IOM) of the National Academies. ``The
Development of the DRIs, 1994-2004: Lessons Learned and New
Challenges, Workshop Summary'', Washington, DC: National Academies
Press; 2008.
14. Institute of Medicine (IOM) of the National Academies. ``How
Should the Recommended Dietary Allowances Be Revised'', Washington,
DC: National Academies Press; 1994.
15. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes: The Essential Guide to Nutrient Requirements'',
Washington DC: National Academies Press; 2006.
16. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D,
and Fluoride'', Washington, DC: National Academies Press; 1997.
17. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6,
Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline'',
Washington, DC: National Academy Press; 1998.
18. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Vitamin C, Vitamin E, Selenium, and
Carotenoids'', Washington, DC: National Academies Press; 2000.
19. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron,
Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel,
Silicon, Vanadium, and Zinc'', Washington, DC: National Academies
Press; 2001.
20. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids (Macronutrients), Summary'',
Washington, DC: National Academies Press; 2002. pp. 1-19.
21. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Water, Potassium, Sodium, Chloride, and
Sulfate'', Washington, DC: National Academies Press; 2005.
22. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Calcium and Vitamin D'', Washington, DC:
National Academies Press; 2011.
23. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids (Macronutrients)'',
Washington, DC: National Academies Press; 2002.
24. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes: Proposed Definition of Dietary Fiber'',
Washington DC: National Academies Press; 2001.
25. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes: Guiding Principles for Nutrition Labeling and
Fortification'', Washington, DC: National Academies Press; 2003.
26. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes: Applications in Dietary Planning'', Washington,
DC: National Academies Press; 2003.
27. Institute of Medicine (IOM) of the National Academies.
``Strategies to Reduce Sodium Intake in the United States'',
Washington, DC: National Academies Press; 2010.
28. Institute of Medicine (IOM) of the National Academies.
``Examination of Front-of-Package Nutrition Rating Systems and
Symbols: Phase I Report'', Washington, DC: National Academies Press;
2010.
29. Institute of Medicine (IOM) of the National Academies. ``Front-
of-Package Nutrition Rating Systems and Symbols: Promoting Healthier
Choices'', Washington, DC: National Academies Press; 2012.
30. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. (2010) ``Report of the Dietary Guidelines Advisory
Committee on the Dietary Guidelines for Americans, 2010'',
Washington, DC: U.S. Government Printing Office. Retrieved from
https://www.cnpp.usda.gov/DGAs2010-DGACReport.htm.
31. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. (1980) ``Nutrition and Your Health, Dietary
Guidelines for Americans, 1980'', Home and Gardening Bulletin No.
232, 1st Ed., Washington, DC: U.S. Government Printing Office.
Retrieved from https://www.health.gov/dietaryguidelines/1980thin.pdf.
32. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. (1985) ``Nutrition and Your Health, Dietary
Guidelines for Americans, 1985'', Home and Gardening Bulletin No.
232, 2nd Ed., Washington,

[[Page 11963]]

DC: U.S. Government Printing Office. Retrieved from https://www.health.gov/dietaryguidelines/1985thin.pdf.
33. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. (1990) ``Nutrition and Your Health, Dietary
Guidelines for Americans, 1990'', Home and Gardening Bulletin No.
232, 3rd Ed., Washington, DC: U.S. Government Printing Office.
Retrieved from https://www.health.gov/DietaryGuidelines/1990thin.pdf.
34. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. (1995) ``Nutrition and Your Health, Dietary
Guidelines for Americans, 1995'', Home and Gardening Bulletin No.
232, 4th Ed., Washington, DC: U.S. Government Printing Office.
Retrieved from https://www.cnpp.usda.gov/Publications/DietaryGuidelines/1995/1995DGConsumerBrochure.pdf.
35. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. (November 30, 2012) ``Nutrition and Your Health,
Dietary Guidelines for Americans, 2000'', Home and Gardening
Bulletin No. 232, 5th Ed., Washington, DC: U.S. Government Printing
Office. Retrieved from https://www.health.gov/dietaryguidelines/dga2000/dietgd.pdf.
36. U.S. Department of Health and Human Services and U.S. Department
of Agriculture. (2005) ``Dietary Guidelines for Americans, 2005''.
6th Edition, Washington, DC: U.S. Government Printing Office.
Retrieved from https://www.health.gov/dietaryguidelines/dga2005/document/pdf/DGA2005.pdf.
37. Centers for Disease Control and Prevention. (September 12, 2012)
``About the National Health and Nutrition Examination Survey''.
Retrieved from https://www.cdc.gov/nchs/nhanes/about_nhanes.htm.
38. Derby, B., Levy, A. ``Do Food Labels Work?''. In: Handbook of
Marketing and Society. Thousand Oaks, CA: Sage; 2000.
39. U.S. Food and Drug Administration. (2007) ``2002 Health and Diet
Survey: Topline Frequency Report''. Retrieved from https://www.fda.gov/food/foodscienceresearch/consumerbehaviorresearch/ucm202786.htm.
40. U.S. Food and Drug Administration. (2008) ``Health and Diet
Survey: Dietary Guidelines Supplement- Report Findings (2004 &
2005)''. Retrieved from https://www.fda.gov/downloads/Food/ScienceResearch/ResearchAreas/ConsumerResearch/UCM080413.pdf.
41. U.S. Food and Drug Administration. (January 1, 2010) ``2008
Health and Diet Survey: Topline Frequencies''. Retrieved from https://www.fda.gov/food/foodscienceresearch/consumerbehaviorresearch/ucm193895.htm.
42. Todd, J. E. ``Changes in Eating Patterns and Diet Quality Among
Working-Age Adults, 2005-10, EER-161'', Washington, DC: U.S.
Department of Agriculture, Economic Research Service; 2014.
43. Levy, L., Patterson, R.E., Kristal, A.R., et al. ``How Well Do
Consumers Understand Percentage Daily Value on Food Labels?''.
American Journal of Health Promotion: AJHP. 2000;14:157-160.
44. Lando, A.M., Labiner-Wolfe, J. ``Helping Consumers Make More
Healthful Food Choices: Consumer Views on Modifying Food Labels and
Providing Point-of-Purchase Nutrition Information at Quick-Service
Restaurants''. Journal of Nutrition Education and Behavior.
2007;39:157-163.
45. International Food Information Council Foundation. (2010) ``Food
Label Consumer Research Project''. Retrieved from https://www.foodinsight.org/Content/3145/FINAL%20IFIC%20Foundation%20Food%20Label%20Consumer%20Research%20-%20Phase%20III%20Summary%20Report.pdf.
46. U.S. Food and Drug Administration. (April 27, 2004) ``Meeting
Minutes From the Nutrition Subcommittee of the Food Advisory
Committee Meeting on Total Fat and Trans Fat''. Retrieved from
https://www.fda.gov/ohrms/dockets/ac/04/minutes/4035m1_FinalSummaryMinutes.htm.
47. U.S. Food and Drug Administration. ``Memorandum to the File:
Comments Considered in the Development of the Revision of the
Nutrition and Supplements Facts Proposed Rule'', 2014.
48. U.S. Food and Drug Administration. ``Memorandum to the File:
Evaluation Process of the Public Health Significance of Essential
Vitamins and Minerals'', 2014.
49. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 8:
Dietary Fats: Total Fat and Fatty Acids'', Washington, DC: National
Academies Press; 2002.
50. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 5:
Energy'', Washington, DC: National Academies Press; 2002.
51. Daintith, J., Martin, E. ``Dictionary of Science, 6th Ed.''.
Oxford University Press; 2010; pp. 314-315.
52. Lewis, R.J., Sr., editor. Hawley's Condensed Chemical
Dictionary. 15th Ed. John Wiley & Sons, 2007; pp. 549-550.
53. deMan, J.M. ``Principles of Food Chemistry, 3rd Ed.''. Springer-
Verlag; 1999; pp. 33-70.
54. Klein S., Cohn S., Alpers D.H. ``Alimentary Tract and
Nutrition''. In: Modern Nutrition In Health and Disease 10th Ed.
Shils M.E., Shike M., Ross A.C., Caballero B., Cousins R.J., eds.
Baltimore, MD: Lippincott Williams & Wilkins; 2006; pp. 1133-1135.
55. Third Report of the National Cholesterol Education Program
(NCEP) Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults (Adult Treatment Panel III) Final
Report. Circulation. 2002;106:3143-3421.
56. Hornick, B.A., Krester, A.J., Nicklas, T.A. ``Menu Modeling with
MyPyramid Food Patterns: Incremental Dietary Changes Lead to
Dramatic Improvements in Diet Quality of Menus''. Journal of the
American Dietetic Association. 2008;108:2077-2083.
57. U.S. Food and Drug Administration. (November 28, 2012) ``Health
Claim Notification for Saturated Fat, Cholesterol, and Trans Fat,
and Reduced Risk of Heart Disease''. Retrieved from https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm073621.htm.
58. Doell, D., Folmer, D., Lee, H., et al. ``Updated Estimate of
Trans Fat Intake by the US Population''. Food Additives &
Contaminants Part A, Chemistry, Analysis, Control, Exposure & Risk
Assessment. 2012;29:861-874.
59. U.S. Food and Drug Administration. (2004) ``Letter Responding to
Health Claim Petition dated November 3, 2003 (Martek Petition):
Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease'',
(Docket No. 2003Q-0401). Retrieved from https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm072932.htm.
60. Yokoyama, M., Origasa, H., Matsuzaki, M., et al. ``Effects of
Eicosapentaenoic Acid on Major Coronary Events in
Hypercholesterolaemic Patients (JELIS): A Randomised Open-Label,
Blinded Endpoint Analysis''. The Lancet. 2007;369:1090-1098.
61. U.S. Food and Drug Administration. (2004) ``Letter Responding to
Health Claim Petition dated August 28, 2003: Monounsaturated Fatty
Acids from Olive Oil and Coronary Heart Disease'', (Docket No.
2003Q-0559). Retrieved from https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm072963.htm.
62. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 9:
Cholesterol'', Washington, DC: National Academies Press; 2002.
63. Merrill, A. L., Watt, B. K. `` ``Energy Value of Foods. Basis
and Derivation'', Human Nutrition Research Branch, Agricultural
Research Service, U.S. Department of Agriculture, Agriculture
Handbook No. 74'', 1973.
64. Higson S. Analytical Chemistry. 1st Ed. Oxford, NY: Oxford
University Press, 2004;pp. 19-27.
65. U.S. Department of Agriculture, Agricultural Research Service
USDA Nutrient Data Laboratory. (2010) ``Composition of Foods Raw,
Processed, Prepared, USDA National Nutrient Database for Standard
Reference, Release 23''. Retrieved from https://www.ars.usda.gov/SP2UserFiles/Place/12354500/Data/SR23/sr23_doc.pdf.
66. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein,

[[Page 11964]]

and Amino Acids (Macronutrients), Chapter 7: Dietary, Functional,
and Total Fiber'', Washington, DC: National Academies Press; 2002.
67. Codex Alimentarius. (2010) Guidelines on Nutrition Labeling.
Retrieved from www.codexalimentarius.net/download/standards/34/CXG_002e.pdf.
68. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 6:
Dietary Carbohydrates: Sugars and Starches'', Washington, DC:
National Academies Press; 2002.
69. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 11:
Macronutrients and Healthful Diets'', Washington, DC: National
Academies Press; 2002. pp. 769-879.
70. Putnam, J. J. and Allshouse J.E. (1999) ``Food Consumption,
Prices, and Expenditures, 1970-97''. Food and Rural Economics
Division, Economic Research Service, U.S. Department of Agriculture.
Statistical Bulletin No. 965. Retrieved from https://www.ers.usda.gov/publications/sb965/.
71. Gidding, S.S., Dennison, B.A., Birch, L.L., et al. ``Dietary
Recommendations for Children and Adolescents: A Guide for
Practitioners: Consensus Statement From the American Heart
Association''. Circulation. 2005;112:2061-2075.
72. Johnson, R.K., Appel, L.J., Brands, M., et al. ``Dietary Sugars
Intake and Cardiovascular Health: A Scientific Statement From the
American Heart Association''. Circulation. 2009;120:1011-1020.
73. World Health Organization. ``Diet, Nutrition, and the Prevention
of Chronic Diseases. Report of a WHO Study Group'', Geneva: World
Health Organization; 1990. pp. 1-204.
74. U.S. Food and Drug Administration. (January 1, 2009) ``Guidance
for Industry: Evidence-Based Review System for Scientific Evaluation
of Health Claims--Final''. Retrieved from https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm073332.htm.
75. Center for Science in the Public Interest. (2010) ``Food
Labeling Chaos: The Case for Reform''. Retrieved from https://cspinet.org/new/pdf/food_labeling_chaos_report.pdf.
76. Center for Nutrition Policy and Promotion, U.S. Department of
Agriculture Home and Garden Bulletin No. 252. (1992) ``The Food
Guide Pyramid''. Retrieved from https://www.cnpp.usda.gov/Publications/MyPyramid/OriginalFoodGuidePyramids/FGP/FGPPamphlet.pdf.
77. Skibsted, L.H., Risbo, J., Andersen, M.L. ``Chemical
Deterioration and Physical Instability of Food and Beverages''.
Woodhead Publishing; 2010; pp.70-94.
78. U.S. Food and Drug Administration. ``Memorandum to the File:
Effects of Maillard Reaction, Caramelization, and Fermentation on
Added Sugar Content of Foods'', 2014.
79. Murano, P.S. ``Understanding Food Science and Technology''.
Belmont, California: Wadsworth/Thomas Learning; 2003; pp.123-125.
80. U.S. Food and Drug Administration. ``Memorandum to the File:
Summary of Comments Received to the 1999 CSPI Petition on Added
Sugars, (Docket No. FDA-1999-P-0158 (formerly Docket No. 99P-
2630))'', 2014.
81. Life Sciences Research Office. ``The Evaluation of the Energy of
Certain Sugar Alcohols Used as Food Ingredients'', Bethesda, MD:
Life Sciences Research Office; 1994.
82. Life Sciences Research Office. ``Evaluation of the Net Energy
Value of Maltitol'', Bethesda, MD: Life Sciences Research Office;
1999.
83. McCleary, B.V., DeVries, J.W., Rader, J.I., et al.
``Determination of Total Dietary Fiber (CODEX definition) by
Enzymatic-Gravimetric Method and Liquid Chromatography:
Collaborative Study''. Journal of AOAC International. 2010;93:221-
233.
84. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 10:
Protein and Amino Acids'', Washington, DC: National Academies Press;
2002.
85. U.S. Department of Agriculture, Agricultural Research Service
and the U.S. Department of Health and Human Services Centers for
Disease Control and Prevention National Center for Health
Statistics. (2010) ``What We Eat in America, NHANES 2007-2008'',
Table 1. Nutrient Intakes from Food: Mean Amounts Consumed per
Individual by Gender and Age, in the United States, 2007-2008.
Retrieved from https://www.ars.usda.gov/SP2UserFiles/Place/12355000/pdf/0708/Table_1_NIN_GEN_07.pdf.
86. Joint Food and Agriculture Organization of the United States and
World Health Organization. ``Protein Quality Evaluation, Report of
Joint FAO/WHO Expert Consultation'', Rome: Food and Agriculture
Organization of the United Nations; 1991.
87. Institute of Medicine (IOM) of the National Academies. ``Sodium
Intake in Populations: Assessment of Evidence'', Washington, DC:
National Academies Press; 2013. pp. 235-284.
88. National Research Council (NRC). ``Diet and Health: Implications
for Reducing Chronic Disease Risk'', Washington, DC: National
Academy Press; 1989.
89. Institute of Medicine (IOM) of the National Academies.
``Strategies to Reduce Sodium Intake in the United States, Chapter
8: Committee's Considerations and Basis for Recommendations'',
Washington, DC: National Academies Press; 2010. pp. 235-284.
90. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D,
and Fluoride, Chapter 8: Fluoride'', Washington, DC: National
Academies Press; 1997. pp. 288-313.
91. U.S. Food and Drug Administration. (July 15, 2009) ``Health
Claim Notification for Fluoridated Water and Reduced Risk of Dental
Caries'', October 14, 2006. Retrieved from https://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm073602.htm.
92. U.S. Environmental Protection Agency, Health and Ecological
Criteria Division Office of Water. (December, 2010) ``Fluoride:
Exposure and Relative Source Contribution Analysis''. Retrieved from
https://water.epa.gov/action/advisories/drinking/fluoride_index.cfm.
93. U.S. Department of Health and Human Services. ``The Surgeon
General's Report on Nutrition and Health'', Washington, DC: 1988.
94. Life Sciences Research Office (LSRO), prepared by by the
Department of Health and Human Services. ``Nutrition Monitoring in
the United States, An Update Report on Nutrition Monitoring'',
Washington DC: Government Printing Office; 1989.
95. Institute of Medicine (IOM) of the National Academies.
``Nutrition Labeling: Issues and Directions for the 1990s'',
Washington, DC: National Academy Press; 1990.
96. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes: Applications in Dietary Assessment'', Washington
DC: National Academies Press; 2000.
97. Gibson R.S. Principles of Nutrition Assessment. 2nd Ed. New
York: Oxford University Press, 2005; pp. 373, 513, 534, 602-606.
98. U.S. Department of Health and Human Services. (October 14, 2004)
``Bone Health and Osteoporosis: A Report of the Surgeon General''.
Retrieved from https://www.surgeongeneral.gov/library/reports/bonehealth/.
99. Looker, A.C., Melton, L.J., III, Harris, T.B., et al.
``Prevalence and Trends in Low Femur Bone Density Among Older US
Adults: NHANES 2005-2006 Compared with NHANES III''. Journal of Bone
and Mineral Research: the Official Journal of the American Society
for Bone and Mineral Research. 2010;25:64-71.
100. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic,
Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum,
Nickel, Silicon, Vanadium, and Zinc, Chapter 9: Iron'', Washington,
DC: National Academies Press; 2001. pp. 290-393.
101. Centers for Disease Control and Prevention, National Center for
Environmental Health Division of Laboratory Sciences. (2012)
``Second National Report on Biochemical Indicators of Diet and
Nutrition in the U.S. Population''. Retrieved from

[[Page 11965]]

https://www.cdc.gov/nutritionreport/pdf/Nutrition_Book_complete508_final.pdf#zoom=100.
102. Cook, J.D., Flowers, C.H., Skikne, B.S. ``The Quantitative
Assessment of Body Iron''. Blood. 2003;101:3359-3364.
103. Cogswell, M.E., Looker, A.C., Pfeiffer, C.M., et al.
``Assessment of Iron Deficiency in US Preschool Children and
Nonpregnant Females of Childbearing Age: National Health and
Nutrition Examination Survey 2003-2006''. American Journal of
Clinical Nutrition. 2009;89:1334-1342.
104. U.S. Department of Health and Human Services. (September 1,
2011) Healthy People 2020, Nutrition and Weight Status; Iron
Deficiency Anemia (objective NWS-21): ``Reduce Iron Deficiency Among
Young Children and Females of Childbearing Age''. Retrieved from
https://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicid=29.
105. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic,
Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum,
Nickel, Silicon, Vanadium, and Zinc, Chapter 4: Vitamin A'',
Washington, DC: National Academies Press; 2001. pp. 82-161.
106. The Alpha-Tocopherol, B.C.C.P.S.G. ``The Effect of Vitamin E
and Beta Carotene on the Incidence of Lung Cancer and Other Cancers
in Male Smokers.''. New England Journal of Medicine. 1994;330:1029-
1035.
107. Omenn, G.S., Goodman, G.E., Thornquist, M.D., et al. ``Effects
of a Combination of Beta Carotene and Vitamin A on Lung Cancer and
Cardiovascular Disease''. New England Journal of Medicine.
1996;334:1150-1155.
108. U.S. Food and Drug Administration. (2009) ``Antioxidant
Vitamins C and E and Reduction in the Risk of Site-Specific
Cancers''. Retrieved from https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm166913.htm.
109. U.S. Food and Drug Administration. (November 13, 2011)
``Guidance for Industry: Estimating Dietary Intake of Substances in
Food''. Retrieved from https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ingredientsadditivesgraspackaging/ucm074725.htm.
110. Cappuccio, F.P., MacGregor, G.A. ``Does Potassium
Supplementation Lower Blood Pressure? A Meta-Analysis of Published
Trials''. Journal of Hypertension. 1991;9:465-473.
111. Whelton, P.K., He, J., Cutler, J.A., et al. ``Effects of Oral
Potassium on Blood Pressure. Meta-Analysis of Randomized Controlled
Clinical Trials''. JAMA: The Journal of the American Medical
Association. 1997;277:1624-1632.
112. Geleijnse, J.M., Kok, F.J., Grobbee, D.E. ``Blood Pressure
Response to Changes in Sodium and Potassium Intake: a Metaregression
Analysis of Randomised Trials''. Journal of Human Hypertension.
2003;17:471-480.
113. Centers for Disease Control and Prevention. (2012) ``High Blood
Pressure Facts''. Retrieved from https://www.cdc.gov/bloodpressure/facts.htm.
114. U.S. Food and Drug Administration. (2000) ``Health Claim: Diets
Containing Foods That Are Good Sources of Potassium and Low in
Sodium May Reduce the Risk of High Blood Pressure and Stroke''.
Retrieved from https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm073606.htm.
115. U.S. Food and Drug Administration. ``Memorandum to the File:
Declaration of Current Voluntarily Declared Essential Vitamins and
Minerals and Choline'', 2014.
116. Hill, K.M., Jonnalagadda, S.S., Albertson, A.M., et al. ``Top
Food Sources Contributing to Vitamin D Intake and the Association of
Ready-to-Eat Cereal and Breakfast Consumption Habits to Vitamin D
Intake in Canadians and United States Americans''. Journal of Food
Science. 2012;77:H170-H175.
117. U.S. Census Bureau, Population Projections Program Population
Division. ``(NP-D1-A) Projections of the Resident Population by Age,
Sex, Race, and Hispanic Origin: 1999 to 2100'', Washington, DC: U.S.
Census Bureau; January 13, 2000.
118. World Health Organization. (2007) ``Assessment of Iodine
Deficiency Disorders and Monitoring Their Elimination: A Guide for
Programme Managers''. 3rd Ed. Retrieved from https://whqlibdoc.who.int/publications/2007/9789241595827_eng.pdf.
119. Beaton, G.H. ``When Is an Individual an Individual Versus a
Member of a Group? An Issue in the Application of the Dietary
Reference Intakes''. Nutrition Reviews. 2006;64:211-225.
120. Borra, S. ``Consumer Perspectives on Food Labels''. American
Journal of Clinical Nutrition. 2006;83:1235S-1235S.
121. Fulgoni, V.L., III, Miller, G.D. ``Dietary Reference Intakes
for Food Labeling''. American Journal of Clinical Nutrition.
2006;83:1215S-1216S.
122. Kretser, A.J. ``The New Dietary Reference Intakes in Food
Labeling: The Food Industry's Perspective''. American Journal of
Clinical Nutrition. 2006;83:1231S-1234S.
123. Murphy, S.P., Barr, S.I., Yates, A.A. ``The Recommended Dietary
Allowance (RDA) Should Not Be Abandoned: An Individual Is Both an
Individual and a Member of a Group''. Nutrition Reviews.
2006;64:313-315.
124. Murphy, S.P., Barr, S.I. ``Recommended Dietary Allowances
Should Be Used to Set Daily Values for Nutrition Labeling''.
American Journal of Clinical Nutrition. 2006;83:1223S-1227S.
125. Tarasuk, V. ``Use of Population-Weighted Estimated Average
Requirements as a Basis for Daily Values on Food Labels''. American
Journal of Clinical Nutrition. 2006;83:1217S-1222S.
126. Yates, A.A. ``Which Dietary Reference Intake Is Best Suited to
Serve as the Basis for Nutrition Labeling for Daily Values?''. The
Journal of Nutrition. 2006;136:2457-2462.
127. International Food Information Council (IFIC) Foundation.
(2007) ``2007 Food & Health Survey: Consumer Attitudes Toward Food,
Nutrition & Health''. Retrieved from https://www.foodinsight.org/Content/6/2007Survey-FINAL.pdf.
128. International Food Information Council (IFIC) Foundation.
(2010) ``2010 Food & Health Survey: Consumer Attitudes Toward Food
Safety, Nutrition & Health''. Retrieved from https://www.foodinsight.org/Resources/Detail.aspx?topic=2010_Food_Health_Survey_Consumer_Attitudes_Toward_Food_Safety_Nutrition_Health.
129. International Food Information Council (IFIC) Foundation.
(2006) ``2006 Food & Health Survey: Consumer Attitudes Toward Food,
Nutrition & Health''. Retrieved from https://www.foodinsight.org/Resources/Detail.aspx?topic=Food_Health_Survey_Consumer_Attitudes_toward_Food_Nutrition_Health_2006_.
130. International Food Information Council (IFIC) Foundation.
(2009) ``2009 Food & Health Survey: Consumer Attitudes Toward Food,
Nutrition & Health''. Retrieved from https://www.foodinsight.org/Resources/Detail.aspx?topic=2009_Food_Health_Survey_Consumer_Attitudes_toward_Food_Nutrition_and_Health.
131. U.S. Department of Agriculture, Center for Nutrition Policy and
Promotion. (2011) ``USDA Food Patterns, Comparison of Nutrient
Content of Each 2010 USDA Food Pattern to Nutrition Goals for That
Pattern''. Retrieved from https://www.cnpp.usda.gov/Publications/USDAFoodPatterns/ComparisonofNutrientContentofeach2010USDAFoodPatterntoNutritionalGoalsforthatPattern.pdf.
132. U.S. Food and Drug Administration. ``Memorandum to the File:
Documentation for the Methodology Used to Determine Total Usual
Intakes of Vitamins and Minerals Compared to Tolerable Upper Levels
(UL) and Results of Analysis'', 2014.
133. Block L., Peracchio L. ``The Calcium Quandry: How Consumers Use
Nutrition Labels''. Journal of Public Policy Marketing. 2006;25:188-
196.
134. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic,
Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum,
Nickel, Silicon, Vanadium, and Zinc, Chapter 5: Vitamin K'',
Washington, DC: National Academies Press; 2001. pp. 162-196.
135. National Research Council (NRC). ``Recommended Dietary
Allowances, 9th Ed.'', Washington, DC: National Academy Press; 1980.

[[Page 11966]]

136. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Water, Potassium, Sodium, Chloride,
and Sulfate, Chapter 5: Potassium'', Washington, DC: National
Academies Press; 2005. pp. 186-268.
137. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin
B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline,
Chapter 12: Choline'', Washington, DC: National Academy Press; 1998.
pp. 390-422.
138. U.S. Food and Drug Administration, Center for Food Safety and
Applied Nutrition. (August 30, 2001) ``Nutrient Content Claims
Notification for Choline Containing Foods''. Retrieved from https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm073599.htm.
139. O'Neil, C.E., Keast, D.R., Fulgoni, V.L., et al. ``Food Sources
of Energy and Nutrients Among Adults in the US: NHANES 2003-2006''.
Nutrients. 2012;4:2097-2120.
140. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic,
Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum,
Nickel, Silicon, Vanadium, and Zinc, Summary'', Washington, DC:
National Academies Press; 2001. pp. 1-28.
141. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin
B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline,
Chapter 8: Folate'', Washington, DC: National Academy Press; 1998.
pp. 196-305.
142. U.S. Pharmacopeia. ``The National Formulary, 15th Ed.'',
Rockville, MD: United States Pharmacopeial Convention, Inc.; 1980.
pp. 846-847.
143. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and
Carotenoids, Chapter 6: Vitamin E'', Washington, DC: National
Academies Press; 2000. pp. 186-283.
144. U.S. Food and Drug Administration, Office of Nutritional
Products Labeling and Dietary Supplements. (2013) ``Guidance for
Industry: A Food Labeling Guide''. Retrieved from https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm2006828.htm.
145. Breastfeeding and the Use of Human Milk. Pediatrics.
2012;129:e827-e841.
146. U.S. Department of Health and Human Services, National
Institutes of Health, and National, Heart Lung and Blood Institute.
(October, 2012) ``Integrated Guidelines for Cardiovascular Health
and Risk Reduction In Children and Adolescents: The Report of the
Expert Panel''; NIH Publication No. 12-7486A. Retrieved from https://www.nhlbi.nih.gov/guidelines/cvd_ped/index.htm.
147. Akers, S., Groh-Wargo, S. ``Chapter 5: Normal Nutrition During
Infancy''. In: Pediatric Nutrition 4th Ed. Patrica Queen Samour and
Kathy King, ed. Sadbury, MA: Jones and Bartlett Learning; 2012;
p.71.
148. Devaney, B., Ziegler, P., Pac, S., et al. ``Nutrient Intakes of
Infants and Toddlers''. Journal of the American Dietetic
Association. 2004;104:s14-s21.
149. Fox, M.K., Reidy, K., Novak, T., et al. ``Sources of Energy and
Nutrients in the Diets of Infants and Toddlers''. Journal of the
American Dietetic Association. 2006;106:S28-S42.
150. Butte, N.F., Fox, M.K., Briefel, R.R., et al. ``Nutrient
Intakes of US Infants, Toddlers, and Preschoolers Meet or Exceed
Dietary Reference Intakes''. Journal of the American Dietetic
Association. 2010;110:S27-S37.
151. American Academy of Pediatrics. ``Chapter 32: Hyperlipidemia
and Prevention of Cardiovascular Disease''. In: Pediatric Nutrition
Handbook 6th Ed. Kleinman, R.E., ed. American Academy of Pediatrics;
2009; p.723.
152. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Calcium, Phosphorous, Magnesium,
Vitamin D, and Fluoride, Chapter 4: Calcium'', Washington, DC:
National Academies Press; 1997. pp. 71-145.
153. Greer, F.R., Krebs, N.F. ``Optimizing Bone Health and Calcium
Intakes of Infants, Children, and Adolescents''. Pediatrics.
2006;117:578-585.
154. Polhamus, B., Delenius, K., Makentosh, H., Smith, B., and
Grummer-Strawn, L. (2011) ``Pediatric Nutrition Surveillance 2009
Report''. Retrieved from https://www.cdc.gov/pednss/pdfs/PedNSS_2009.pdf.
155. Looker, A.C., Dallman, P.R., Carroll, M.D., et al. ``Prevalence
of Iron Deficiency in the United States''. JAMA: the Journal of the
American Medical Association. 1997;277:973-976.
156. Centers for Disease Control and Prevention. (September 9, 2010)
``Growth Charts''. Retrieved from https://www.cdc.gov/growthcharts/who_charts.htm.
157. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat,
Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients),
Chapter 1: Introduction to Dietary Reference Intakes'', Washington,
DC: National Academies Press; 2002. pp. 21-37.
158. Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic,
Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum,
Nickel, Silicon, Vanadium, and Zinc, Chapter 12: Zinc'', Washington,
DC: National Academies Press; 2001. pp. 442-501.
159. Cusick, S.E., Mei, Z., Freedman, D.S., et al. ``Unexplained
Decline in the Prevalence of Anemia Among US Children and Women
Between 1988-1994 and 1999-2002''. American Journal of Clinical
Nutrition. 2008;88:1611-1617.
160. Gomez-Palacio B., Vit A. Graphic Design Referenced: A Visual
Guide to the Language, Applications, and History of Graphic Design.
1st Ed. Beverly, MA: Rockport Publishers, 2012;pp. 50-54.
161. Levy, A., Fein, S.B., Schucker, R.E. ``Nutrition Labeling
Formats: Performance and Preference''. Food Technology. 1991;45:116-
121.
162. Levy, A.S., Fein, S.B., Schucker, R.E. ``More Effective
Nutrition Label Formats Are Not Necessarily Preferred''. Journal of
the American Dietetic Association. 1992;92:1230-1234.
163. Levy, A.S., Fein, S.B., Schucker, R.E. ``Performance
Characteristics of Seven Nutrition Label Formats''. American Journal
of Health Promotion. 1992;14:157-160.
164. Lando, A.M., Lo, S.C. ``Single-Larger-Portion-Size and Dual-
Column Nutrition Labeling May Help Consumers Make More Healthful
Food Choices''. Journal of the Academy of Nutrition and Dietetics.
2013;113:241-250.
165. U.S. Food and Drug Administration. (December 5, 2012)
``Calories Count: Report of the Working Group on Obesity'', March
12, 2004. Retrieved from https://www.fda.gov/food/foodscienceresearch/consumerbehaviorresearch/ucm081696.htm.
166. Knemeyer, D. (July 15, 2003) ``Information Design: The
Understanding Discipline''. Retrieved from https://boxesandarrows.com/information-design-the-understanding-discipline/.
167. Lidwell, W., Holden, K., Butler, J., editors. Universal
Principles of Design. 1st Ed. Beverly, MA: Rockport Publishers,
2003;pp. 40-41.
168. Goldberg, J.H., Probart, C.K., Zak, R.E. ``Visual Search of
Food Nutrition Labels''. Human Factors. 1999;41:425-437.
169. Wogalter, M.S., Leonard, S.D. ``Chapter 7: Attention Capture
and Maintenance''. In: Warnings in Risk Communication Philadelphia:
Taylor and Francis Inc.; 1999; pp.123-148.
170. Wogalter, M.S., Vigilante, W.J., Jr. ``Effects of Label Format
on Knowledge Acquisition and Perceived Readability by Younger and
Older Adults''. Ergonomics. 2003;46:327-344.
171. Lupton E. Thinking With Type: A Critical Guide for Designers,
Writers, Editors, & Students. 2nd Ed. New York, NY: Princeton
Archetectural Press, 2010; pp. 132-133.
172. Marino, C.J., Mahan, R.R. ``Configural Displays Can Improve
Nutrition-Related Decisions: An Application of the Proximity
Compatibility Principle''. Human Factors. 2005;47:121-130.
173. Vessey, I., Galletta, D. ``Cognitive Fit: An Empirical Study of
Information Acquisition''. Information Systems Research. 1991;2:63-
84.
174. Campos, S.e.al. ``Nutrition Labels on Pre-Packaged Foods: A
Systematic Review''. Public Health Nutrition. 2011;14:1496-1506.
175. Cowburn, G., Stockley L. ``Consumer Understanding and Use of
Nutrition

[[Page 11967]]

Labeling: A Systematic Review''. Public Health Nutrition. 2005;8:21-
28.
176. Fagerlin A., Peters E. ``Quantitative Information (Chapter
7)''. In: Communicating Risks and Benefits: An Evidence-Based User's
Guide Ed. Fischhoff, B., Brewer, N.T., Downs, J.S., eds. Silver
Spring, MD: U.S. Food and Drug Administration, U.S. Department of
Health and Human Services; 2011; pp.53-62.
177. Li, F., Miniard, P.W., Barone, M.J. ``The Facilitating
Influence of Consumer Knowledge on the Effectiveness of Daily Value
Reference Information''. Journal of the Academy of Marketing
Science. 2000;28:425-436.
178. Riis J., Ratner R. ``Simplified Nutrition Guidelines to Fight
Obesity''. In: Leveraging Consumer Psychology for Effective Health
Communications--The Obesity Challenge Ed. Batra, R., Keller, P.A.,
Strecher, V.J., eds. Armonk, NY: Society for Consumer Psychology,
M.E. Sharp; 2011.
179. U.S. Food and Drug Administration. (2014) ``Spot the Block
Campaign''. Retrieved from https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm281746.htm.
180. U.S. Food and Drug Administration. (March 13, 2013) ``A Key to
Choosing Healthful Foods: Using the Nutrition Facts on the Food
Label''. Retrieved from https://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079449.htm.
181. U.S. Food and Drug Administration, Office of Nutrition Labeling
and Dietary Supplements. ``Memorandum to the File: Documentation of
Web sites that Use the 5/20 Rule'', 2014.
182. White A. The Elements of Graphic Design. 2nd Ed. New York, NY:
Allworth Press, 2011;pp. 167-169, 187.
183. Dictionary.com Unabridged. (2014) ``Carb''. Retrieved from
https://dictionary.reference.com/browse/carb.
184. Google. (2014) Google Trends Search Terms ``Total Carb'' and
``Total Carbs''. Retrieved from https://www.google.com/trends/.
185. Kessler D.A., Mande J.R., Scarbrough E., et al. ``Developing
the ``Nutrition Facts'' Food Label''. Harvard Health Policy Review.
2003;4:13-24.
186. Viswanathan, M., Hastak, M., Gau, R. ``Understanding and
Facilitating the Usage of Nutritional Labels by Low-Literate
Consumers''. Journal of Public Policy Marketing. 2009;28:135-145.
187. U.S. Food and Drug Administration. ``Preliminary Regulatory
Impact Analysis (PRIA) for the Food Labeling: Revision of the
Nutrition and Supplement Facts Labels Notice of Proposed Rulemaking
(Docket No. FDA-2012-N-1210) and Food Labeling: Serving Sizes of
Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-
Column Labeling; Updating, Modifying, and Establishing Certain
Reference Amounts Customarily Consumed; Serving Size for Breath
Mints; and Technical Amendments Notice of Proposed Rulemaking
(Docket No. FDA-2004-N-0258)'', 2014.
188. U.S. Food and Drug Administration. ``Environmental Assessment
for the Revision of the Nutrition and Supplement Facts Labels'',
February 14,2014.
189. U.S. Food and Drug Administration. ``Finding of No Significant
Impact for the Proposed Revisions to the Nutrition and Supplement
Facts Labels'', February 13, 2014.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

0
1. The authority for 21 CFR part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. In Sec. 101.9:
0
a. Revise paragraphs (c) introductory text, (c)(1)(i)(A), (c)(1)(i)(C)
through (E) (c)(2) introductory text, (c)(5), (c)(6)(i), (c)(6)(iii)
and (iv), (c)(7), (c)(8) introductory text, (c)(8)(i), (c)(8)(ii)
introductory text, (c)(8)(iii) through (v), (c)(9), (d)(1) introductory
text, (d)(1)(ii)(C), (d)(1)(iii) through (v), (d)(2), (d)(3)(i) and
(ii), (d)(4) through (8), (d)(10) through (12), (d)(13)(ii), (e), (f)
introductory text, (f)(2)(ii), (f)(4) and (5), (g) introductory text,
(g)(2), (g)(3)(ii), (g)(4) through (8), (h)(3)(iv), (h)(4) introductory
text, (j)(5)(i), (j)(5)(ii) introductory text, (j)(5)(ii)(A),
(j)(13)(ii)(A)(1) and (2), (j)(13)(ii)(B) and (C), and (j)(18)(iv)
introductory text.
0
b. Remove paragraph (c)(1)(ii), redesignate paragraph (c)(1)(iii) as
(c)(1)(ii), and revise newly designated paragraph (c)(1)(ii);
0
c. Remove paragraph (c)(6)(iv), redesignate paragraph (c)(6)(iii) as
(c)(6)(iv), and add new paragraph (c)(6)(iii);
0
d. Add paragraphs (c)(1)(i)(F), (c)(8)(vii), (g)(10), and (g)(11);
0
e. Remove and reserve paragraph (d)(9);
0
f. Remove paragraphs (e)(3)(i) and (e)(3)(ii); and
0
j. Remove paragraphs (j)(5)(ii)(B) through (j)(5)(ii)(D), and
redesignate paragraph (j)(5)(ii)(E) as (j)(5)(ii)(B).
The revisions read as follows:

Sec. 101.9 Nutrition labeling of food.

* * * * *
(c) The declaration of nutrition information on the label and in
labeling of food for adults and children over the age of 4 years, and
on foods (other than infant formula) purported to be specifically for
infants 7 through 12 months, children 1 through 3 years of age, and
pregnant and lactating women, shall contain information about the level
of the following nutrients, except for those nutrients whose inclusion,
and the declaration of the amounts, is voluntary as set forth in this
paragraph. No nutrients or food components other than those listed in
this paragraph as either mandatory or voluntary may be included within
the nutrition label. Except as provided for in paragraphs (f) or (j) of
this section, nutrient information shall be presented using the
nutrient names specified and in the following order in the formats
specified in paragraphs (d) or (e) of this section.
(1) * * *
(i) * * *
(A) Using specific Atwater factors (i.e., the Atwater method) given
in table 13, ``Energy Value of Foods--Basis and Derivation,'' by A. L.
Merrill and B. K. Watt, United States Department of Agriculture (USDA)
Handbook No. 74 (slightly revised, 1973), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is
available from the Office of Nutrition, Labeling, and Dietary
Supplements (HFS-800), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or may be inspected at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.;
* * * * *
(C) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate (less the amount of non-digestible
carbohydrates and sugar alcohols), and total fat, respectively, as
described in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51 (the availability of this incorporation by reference
is given in paragraph (c)(1)(i)(A) of this section). A general factor
of 2 calories per gram for soluble non-digestible carbohydrates shall
be used. The general factors for caloric value of sugar alcohols
provided in paragraph (c)(1)(i)(F) of this section shall be used;
(D) Using data for specific food factors for particular foods or
ingredients approved by the Food and Drug Administration (FDA) and
provided in parts 172 or 184 of this chapter, or by other means, as
appropriate;

[[Page 11968]]

(E) Using bomb calorimetry data subtracting 1.25 calories per gram
protein to correct for incomplete digestibility, as described in USDA
Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the
availability of this incorporation by reference is given in paragraph
(c)(1)(i)(A) of this section);

(F) Using the following general factors for caloric value of sugar
alcohols: Isomalt--2.0 calories per gram, lactitol--2.0 calories per
gram, xylitol--2.4 calories per gram, maltitol--2.1 calories per gram,
sorbitol--2.6 calories per gram, hydrogenated starch hydrolysates--3.0
calories per gram, and mannitol--1.6 calories per gram.
(ii) ``Calories from saturated fat'' or ``Calories from saturated''
(VOLUNTARY): A statement of the caloric content derived from saturated
fat as defined in paragraph (c)(2)(i) of this section in a serving may
be declared voluntarily, expressed to the nearest 5-calorie increment,
up to and including 50 calories, and the nearest 10-calorie increment
above 50 calories, except that amounts less than 5 calories may be
expressed as zero. This statement shall be indented under the statement
of calories as provided in paragraph (d)(5) of this section.
(2) ``Fat, total'' or ``Total fat'': A statement of the number of
grams of total fat in a serving defined as total lipid fatty acids and
expressed as triglycerides where fatty acids are aliphatic carboxylic
acids consisting of a chain of alkyl groups and characterized by a
terminal carboxyl group. Amounts shall be expressed to the nearest 0.5
(1/2) gram increment below 5 grams and to the nearest gram increment
above 5 grams. If the serving contains less than 0.5 gram, the content
shall be expressed as zero.
* * * * *
(5) ``Fluoride'' (VOLUNTARY): A statement of the number of
milligrams of fluoride in a specified serving of food may be declared
voluntarily, except that when a claim is made about fluoride content,
label declaration shall be required. Fluoride content shall be
expressed as zero when the serving contains less than 0.1 milligrams of
fluoride, to the nearest 0.1-milligram increment when the serving
contains less than or equal to 0.8 milligrams of fluoride, and the
nearest 0.2 milligram-increment when a serving contains more than 0.8
milligrams of fluoride.
(6) * * *
(i) ``Dietary fiber'': A statement of the number of grams of total
dietary fiber in a serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required or, alternatively, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and
if the serving contains less than 0.5 gram, the content may be
expressed as zero. Dietary fiber is defined as non-digestible soluble
and insoluble carbohydrates (with 3 or more monomeric units) and lignin
that are intrinsic and intact in plants; isolated and synthetic non-
digestible carbohydrates (with 3 or more monomeric units) that FDA has
granted be included in the definition of dietary fiber, in response to
a petition submitted to FDA under Sec. 10.30 (21 CFR 10.30)
demonstrating that such carbohydrates have a physiological effect(s)
that is beneficial to human health; or isolated and synthetic non-
digestible carbohydrates (with 3 or more monomeric units) that are the
subject of an authorized health claim. Except as provided for in
paragraph (f) of this section, if dietary fiber content is not
required, and as a result not declared, the statement ``Not a
significant source of dietary fiber'' shall be placed at the bottom of
the table of nutrient values in the same type size. Dietary fiber
content may be determined by subtracting the amount of non-digestible
carbohydrates added during processing that do not meet the definition
of dietary fiber from the value obtained using AOAC 2009.01, AOAC
2011.25, or an equivalent method of analysis as given in the ``Official
Methods of Analysis of the AOAC International,'' 19th Ed. (2012), which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51 in paragraph (g)(2). The following isolated and synthetic
non-digestible carbohydrate(s) have been determined by FDA to have
physiological effects that are beneficial to human health and,
therefore, shall be included in the calculation of the amount of
dietary fiber: [beta]-glucan soluble fiber (as described in Sec.
101.81(c)(2)(ii)(A)) and barley [beta]-fiber (as described in Sec.
101.81(c)(2)(ii)(A)(6)). Manufacturers may submit a citizen petition in
accordance with the requirements of Sec. 10.30 to request that FDA
allow for the declaration of the gram amount of an isolated and
synthetic non-digestible carbohydrate or a health claim petition in
accordance with the requirements of Sec. 101.70 for an isolated and
synthetic non-digestible carbohydrate. The manufacturer must make and
keep records in accordance with paragraphs (g)(10) and (g)(11) of this
section to verify the declared amount of dietary fiber in the label and
labeling of food when a mixture of dietary fiber, and added non-
digestible carbohydrate(s) that does not meet the definition of dietary
fiber, is present in the food.
(A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of
grams of soluble dietary fiber in a serving may be declared voluntarily
except that when a claim is made on the label or in labeling about
soluble fiber, label declaration shall be required. Soluble fiber must
meet the definition of dietary fiber in this paragraph (c)(6)(i).
Soluble fiber may be determined using AOAC 2011.25 or an equivalent
method of analysis as given in the ``Official Methods of Analysis of
the AOAC International,'' 19th Ed. (2012), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 in
paragraph (g)(2). The manufacturer must make and keep records in
accordance with paragraphs (g)(10) and (g)(11) of this section to
verify the declared amount of soluble fiber in the label and labeling
of food when a mixture of soluble fiber and added non-digestible
carbohydrate(s) that does not meet the definition of dietary fiber is
present in the food. Soluble fiber content shall be indented under
dietary fiber and expressed to the nearest gram, except that if a
serving contains less than 1 gram, the statement ``Contains less than 1
gram'' or ``less than 1 gram'' may be used as an alternative, and if
the serving contains less than 0.5 gram, the content may be expressed
as zero.''
(B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of
grams of insoluble dietary fiber in a serving may be declared
voluntarily except that when a claim is made on the label or in
labeling about insoluble fiber, label declaration shall be required.
Insoluble fiber must meet the definition of dietary fiber in this
paragraph (c)(6)(i). Insoluble fiber may be determined using AOAC
2011.25 or an equivalent method of analysis as given in the ``Official
Methods of Analysis of the AOAC International,'' 19th Ed. (2012), which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51 in paragraph (g)(2) of this section. The manufacturer must
make and keep records in accordance with paragraphs (g)(10) and (g)(11)
of this section to verify the declared amount of insoluble fiber in the
label and labeling of food when a mixture of insoluble and added non-
digestible carbohydrate(s) that does not meet the definition of dietary
fiber is present in the food. Insoluble fiber content shall be indented
under dietary

[[Page 11969]]

fiber and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero.''
* * * * *
(iii) ``Added Sugars'': A statement of the number of grams of added
sugars in a serving, except that label declaration of added sugars
content is not required for products that contain less than 1 gram of
added sugars in a serving if no claims are made about sweeteners,
sugars, added sugars, or sugar alcohol content. If a statement of the
added sugars content is not required and, as a result, not declared,
the statement ``Not a significant source of added sugars'' shall be
placed at the bottom of the table of nutrient values in the same type
size. Added sugars shall be defined as sugars that are either added
during the processing of foods, or are packaged as such, and include
sugars (free, mono- and disaccharides), syrups, naturally occurring
sugars that are isolated from a whole food and concentrated so that
sugar is the primary component (e.g., fruit juice concentrates), and
other caloric sweeteners. Added sugars content shall be indented under
sugars and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero. When a mixture of naturally occurring and added sugars is present
in the food, and for specific foods containing added sugars, alone or
in combination with naturally occurring sugars, where the added sugars
are subject to fermentation, the manufacturer must make and keep
records in accordance with paragraphs (g)(10) and (g)(11) of this
section to verify the declared amount of added sugars in the label and
labeling of food.
(iv) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of
grams of sugar alcohols in a serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol or sugars when sugar alcohols are present in the
food, sugar alcohol content shall be declared. For nutrition labeling
purposes, sugar alcohols are defined as the sum of saccharide
derivatives in which a hydroxyl group replaces a ketone or aldehyde
group and whose use in the food is listed by FDA (e.g., mannitol or
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu
of the term ``sugar alcohol,'' the name of the specific sugar alcohol
(e.g., ``xylitol'') present in the food may be used in the nutrition
label provided that only one sugar alcohol is present in the food.
Sugar alcohol content shall be indented and expressed to the nearest
gram, except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the
content may be expressed as zero.
(7) ``Protein'': A statement of the number of grams of protein in a
serving, expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero. When the protein in foods represented or purported to be for
adults and children 4 or more years of age has a protein quality value
that is a protein digestibility-corrected amino acid score of less than
20 expressed as a percent, or when the protein in a food represented or
purported to be for children greater than 1 but less than 4 years of
age has a protein quality value that is a protein digestibility-
corrected amino acid score of less than 40 expressed as a percent,
either of the following shall be placed adjacent to the declaration of
protein content by weight: The statement ``not a significant source of
protein,'' or a listing aligned under the column headed ``Percent Daily
Value'' of the corrected amount of protein per serving, as determined
in paragraph (c)(7)(ii) of this section, calculated as a percentage of
the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as
appropriate, for protein and expressed as a Percent of Daily Value.
When the protein quality in a food as measured by the Protein
Efficiency Ratio (PER) is less than 40 percent of the reference
standard (casein) for a food represented or purported to be
specifically for infants 7 through 12 months, the statement ``not a
significant source of protein'' shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on
the basis of the factor 6.25 times the nitrogen content of the food as
determined by the appropriate method of analysis as given in the
``Official Methods of Analysis of the AOAC International,'' 19th Ed.
(2012), which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51, except when the official procedure for a
specific food requires another factor. Copies may be obtained from AOAC
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, or may be inspected at the National Archives and Records
Administration (NARA). For more information on the availability of this
material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(i) A statement of the corrected amount of protein per serving, as
determined in paragraph (c)(7)(ii) of this section, calculated as a
percentage of the RDI or DRV for protein, as appropriate, and expressed
as Percent of Daily Value, may be placed on the label, except that such
a statement shall be given if a protein claim is made for the product,
or if the product is represented or purported to be specifically for
infants 7 through 12 months or children 1 through 3 years of age. When
such a declaration is provided, it should be placed on the label
adjacent to the statement of grams of protein and aligned under the
column headed ``Percent Daily Value,'' and expressed to the nearest
whole percent. However, the percentage of the RDI for protein shall not
be declared if the food is represented or purported to be specifically
for infants 7 through 12 months and the protein quality value is less
than 40 percent of the reference standard.
(ii) The ``corrected amount of protein (gram) per serving'' for
foods represented or purported for adults and children 1 or more years
of age is equal to the actual amount of protein (gram) per serving
multiplied by the amino acid score corrected for protein digestibility.
If the corrected score is above 1.00, then it shall be set at 1.00. The
protein digestibility-corrected amino acid score shall be determined by
methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein Quality
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein
Quality Evaluation,'' Rome, 1991, except that when official AOAC
procedures described in this paragraph (c)(7) require a specific food
factor other than 6.25, that specific factor shall be used. The
``Report of the Joint FAO/WHO Expert Consultation on Protein Quality
Evaluation'' as published by the Food and Agriculture Organization of
the United Nations/World Health Organization is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is
available from the Office of Nutrition, Labeling, and Dietary
Supplements (HFS-800), Center for Food Safety and Applied Nutrition,
Food and Drug

[[Page 11970]]

Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may
be inspected at the National Archives and Records Administration
(NARA). For more information on the availability of this material at
NARA, call 202-741-6030, or go to: https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. For foods
represented or purported to be specifically for infants 7 through 12
months, the corrected amount of protein (grams) per serving is equal to
the actual amount of protein (grams) per serving multiplied by the
relative protein quality value. The relative protein quality value
shall be determined by dividing the subject food protein PER value by
the PER value for casein. If the relative protein value is above 1.00,
it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the DRV or RDI,
a value of 50 grams of protein shall be the DRV for adults and children
4 or more years of age, a value of 11 grams of protein shall be the RDI
for infants 7 through 12 months, a value of 13 grams shall be the DRV
for children 1 through 3 years of age, and a value of 71 grams of
protein shall be the RDI for pregnant and lactating women.
(8) Vitamins and minerals: A statement of the amount per serving of
the vitamins and minerals as described in this paragraph, expressed as
a quantitative amount by weight using the appropriate unit of measure
provided in paragraph (c)(8)(iv) of this section and as a percent of
Daily Value calculated as a percent of the RDI provided in paragraph
(c)(8)(iv) of this section.
(i) For purposes of declaration of percent of Daily Value as
provided for in paragraphs (d), (e), and (f) of this section, foods
represented or purported to be specifically for infants 7 through 12
months, children 1 through 3 years, and pregnant and lactating women
shall use the RDIs that are specified for the intended group. For foods
represented or purported to be specifically for both infants 7 through
12 months and children 1 through 3 years of age, the percent of Daily
Value shall be presented by separate declarations according to
paragraph (e) of this section based on the RDI values for infants 7
through 12 months and children 1 through 3 years of age. When such dual
declaration is used on any label, it shall be included in all labeling,
and equal prominence shall be given to both values in all such
labeling. The percent Daily Value based on the RDI values for pregnant
and lactating women shall be declared on food represented or purported
to be specifically for pregnant and lactating women. All other foods
shall use the RDI for adults and children 4 or more years of age.
(ii) The declaration of vitamins and minerals as a quantitative
amount by weight and percent of the RDI shall include vitamin D,
calcium, iron, and potassium in that order, for infants 7 through 12
months, children 1 through 3 years of age, pregnant and lactating
women, and adults and children 4 or more years of age. The declaration
of vitamins and minerals as a quantitative amount by weight and percent
of the RDI shall include any of the other vitamins and minerals listed
in paragraph (c)(8)(iv) of this section when they are added as a
nutrient supplement, or when a claim is made about them. Other vitamins
and minerals need not be declared if neither the nutrient nor the
component is otherwise referred to on the label or the labeling or
advertising and the vitamins and minerals are:
* * * * *
(iii) The percentages for vitamins and minerals shall be expressed
to the nearest 2-percent increment above 10 percent and up to and
including the 50-percent level. Quantitative amounts and percentages of
vitamins and minerals present at less than 2 percent of the RDI are not
required to be declared in nutrition labeling but may be declared by a
zero or by the use of an asterisk (or other symbol) that refers to
another asterisk (or symbol) that is placed at the bottom of the table
and that is followed by the statement ``Contains less than 2 percent of
the Daily Value of this (these) nutrient (nutrients)'' or ``Contains <
2 percent of the Daily Value of this (these) nutrient (nutrients).''
Alternatively, except as provided for in paragraph (f) of this section,
if vitamin D, calcium, iron, or potassium is present in amounts less
than 2 percent of the RDI, label declaration of the nutrient(s) is not
required if the statement ``Not a significant source of ---- (listing
the vitamins or minerals omitted)'' is placed at the bottom of the
table of nutrient values. Either statement shall be in the same type
size as nutrients that are indented. The quantitative amounts of
vitamins and minerals, excluding sodium, shall be the amount of the
vitamin or mineral included in one serving of the product, using the
units of measurement and the levels of significance given in paragraph
(c)(8)(iv) of this section, except that zeros following decimal points
may be dropped, and additional levels of significance may be used when
the number of decimal places indicated is not sufficient to express
lower amounts (e.g., the RDI for zinc is given in whole milligrams, but
the quantitative amount may be declared in tenths of a milligram).
(iv) The following RDIs, nomenclature, and units of measure are
established for the following vitamins and minerals which are essential
in human nutrition:

--------------------------------------------------------------------------------------------------------------------------------------------------------
RDI
-------------------------------------------------------------------
Nutrient Unit of measure Adults and Infants 7
children >= 4 through 12 Children 1 Pregnant and
years months through 3 years lactating women
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin A....................................... Micrograms RAE \1\ (mcg).......... 900 500 300 1,300
Vitamin C....................................... Milligrams (mg)................... 90 50 15 120
Calcium......................................... Milligrams (mg)................... 1,300 260 700 1,300
Iron............................................ Milligrams (mg)................... 18 11 7 27
Vitamin D....................................... Micrograms (mcg).................. 20 10 15 15
Vitamin E....................................... Milligrams (mg)................... 15 5 6 19
Vitamin K....................................... Micrograms (mcg).................. 120 2.5 30 90
Thiamin......................................... Milligrams (mg)................... 1.2 0.3 0.5 1.4
Riboflavin...................................... Milligrams (mg)................... 1.3 0.4 0.5 1.6
Niacin.......................................... Milligrams NE \2\ (mg)............ 16 4 6 18
Vitamin B6...................................... Milligrams (mg)................... 1.7 0.3 0.5 2.0
Folate \3\...................................... Micrograms DFE \4\ (mcg).......... 400 80 150 600
Vitamin B12..................................... Micrograms (mcg).................. 2.4 0.5 0.9 2.8
Biotin.......................................... Micrograms (mcg).................. 30 6 8 35
Pantothenic acid................................ Milligrams (mg)................... 5 1.8 2 7

[[Page 11971]]

Phosphorous..................................... Milligrams (mg)................... 1,250 275 460 1,250
Iodine.......................................... Micrograms (mcg).................. 150 130 90 290
Magnesium....................................... Milligrams (mg)................... 420 75 80 400
Zinc............................................ Milligrams (mg)................... 11 3 3 13
Selenium........................................ Micrograms (mcg).................. 55 20 20 70
Copper.......................................... Milligrams (mg)................... 0.9 0.2 0.3 1.3
Manganese....................................... Milligrams (mg)................... 2.3 0.6 1.2 2.6
Chromium........................................ Micrograms (mcg).................. 35 5.5 11 45
Molybdenum...................................... Micrograms (mcg).................. 45 3 17 50
Chloride........................................ Milligrams (mg)................... 2,300 570 1500 2300
Potassium....................................... Milligrams (mg)................... 4,700 700 3000 5100
Choline......................................... Milligrams (mg)................... 550 150 200 550
Protein......................................... Grams (g)......................... N/A 11 N/A \5\ 71
--------------------------------------------------------------------------------------------------------------------------------------------------------
A percent daily value must be declared on the label for bolded nutrients.
\1\ RAE = Retinol activity equivalents; 1 RAE = 1 microgram retinol, 12 micrograms [beta]-carotene, or 24 micrograms [alpha]-carotene, or 24 micrograms
[beta]-cryptoxanthin.
\2\ NE = Niacin equivalents, 1 milligram niacin = 60 milligrams of tryptophan.
\3\ ``Folic Acid'' must be used for purposes of declaration in the labeling of dietary supplements. It must also be declared in mcg DFE.
\4\ DFE = Dietary folate equivalents; 1 DFE = 1 microgram food folate = 0.6 micrograms folic acid from fortified food or as a supplement consumed with
food = 0.5 micrograms of a supplement.
\5\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant and lactating women.

(v) The following synonyms may be added in parentheses immediately
following the name of the nutrient or dietary component:

Calories--Energy
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
* * * * *
(vii) When the amount of folate is declared in the labeling of a
conventional food, the nutrient name ``folate'' shall be listed for
products containing either folate alone or a mixture of folate and
folic acid. The name of the synthetic form of the nutrient, ``folic
acid'' shall be used when the nutrient is declared in the labeling of
dietary supplements.
(9) The following DRVs, nomenclature, and units of measure are
established for the following food components:

----------------------------------------------------------------------------------------------------------------
DRV
---------------------------------------------------------------
Food component Unit of Adults and Infants 7 Children 1 Pregnant and
measurement children >= 4 through 12 through 3 lactating
years months years women
----------------------------------------------------------------------------------------------------------------
Fat........................... Grams (g)....... \1\ 65 30 \2\ 39 \1\ 65
Saturated fatty acids......... Grams (g)....... \1\ 20 N/A \2\ 10 \1\ 20
Cholesterol................... Milligrams (mg). 300 N/A 300 300
Total carbohydrate............ Grams (g)....... \1\ 300 95 \2\ 150 \1\ 300
Sodium........................ Milligrams (mg). 2,300 N/A 1,500 2,300
Dietary fiber................. Grams (g)....... \1\ 28 N/A \2\ 14 \1\ 28
Protein....................... Grams (g)....... \1\ 50 N/A \2\ 13 N/A
----------------------------------------------------------------------------------------------------------------
\1\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
for pregnant and lactating women
\2\ Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.

(d)(1) Nutrient information specified in paragraph (c) of this
section shall be presented on foods in the following format, as shown
in paragraph (d)(12) of this section, except on foods where the tabular
display is permitted as provided for in paragraph (d)(11) of this
section, on which dual columns of nutrition information are declared as
provided for in paragraph (e) of this section, on those food products
on which the simplified format is required to be used as provided for
in paragraph (f) of this section, on foods for infants 7 months to 12
months of age and children 1 through 3 years of age as provided for in
paragraph (j)(5) of this section, and on foods in small or
intermediate-sized packages as provided for in paragraph (j)(13) of
this section. In the interest of uniformity of presentation, FDA
strongly recommends that the nutrition information be presented using
the graphic specifications set forth in appendix B to part 101.
* * * * *
(ii) * * *
(C) At least nine points leading (i.e., space between two lines of
text) except that at least 12 points leading shall be utilized for the
information required by paragraphs (d)(7) and (d)(8) of this section as
shown in paragraph (d)(12), and
* * * * *
(iii) Information required in paragraphs (d)(7) and (d)(8) of this
section shall be in type size no smaller than 8 point, except the type
size for this information required in the linear display for small
packages as shown in paragraph (j)(13)(ii)(A)(2) of this section shall
be no smaller than 7 point. Information required in the footnote
statement shall be no smaller than 7 point, except the type size for
this information required in the tabular display for small packages as
shown in paragraph (j)(13)(ii)(A)(1) of this section, for the linear
display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of
this section, and for the simplified format as shown in paragraph
(f)(5) of

[[Page 11972]]

this section shall be no smaller than 6 point. Information required in
paragraph (d)(5) of this section for the ``Calories'' declaration shall
be highlighted in bold or extra bold and shall be in a type size no
smaller than 16 point except the type size for this information
required in the tabular display for small packages as shown in
paragraph (j)(13)(ii)(A)(1) of this section, the linear display for
small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section,
and the required information shown in paragraphs (d)(11)(iii) and
(e)(6)(ii) of this section shall be in a type size no smaller than 12
point. The numeric amount for the information required in paragraph
(d)(5) of this section shall also be highlighted in bold or extra bold
type and shall be in a type size no smaller than 24 point, except the
type size for this information required in the tabular display for
small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section,
the linear display for small packages as shown in paragraph
(j)(13)(ii)(A)(2) of this section, and for the required information
shown in paragraph (e)(6)(ii) of this section shall be in a type size
no smaller than 20 point. The information required in paragraph (d)(6)
of this section shall be in a type size no smaller than 7 point. When
provided, the information described in paragraph (d)(10) of this
section shall be in a type size no smaller than 6 point.
(iv) The headings required by paragraphs (d)(2), (d)(3)(i), and
(d)(6) of this section (i.e., ``Nutrition Facts,'' ``----servings per
container,'' and ``% DV*''), the calorie information, and the names of
all nutrients that are not indented according to requirements of
paragraph (c) of this section (i.e., ``Calories,'' ``Total Fat,''
``Cholesterol,'' ``Sodium,'' ``Total Carbs'' and ``Protein''), and the
percentage amounts required by paragraph (d)(7)(ii) of this section
shall be highlighted in bold or extra bold type or other highlighting
(reverse printing is not permitted as a form of highlighting) that
prominently distinguishes it from other information. The names of all
nutrients that are indented according to the requirements of paragraph
(c) of this section (i.e., ``Saturated Fat,'' ``Trans Fat,'' ``Dietary
Fiber,'' ``Sugars,'' and ``Added Sugars'') and the mandatory and any
voluntary vitamins and minerals (except sodium), shall be highlighted
in a type that is intermediate between bold or extra bold type and the
type for all other information.
(v) A hairline rule that is centered between the lines of text
shall separate ``Nutrition Facts'' from the servings per container
statement required in paragraph (d)(3)(i) of this section and shall
separate each nutrient and its corresponding percent Daily Value
required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from
the nutrient and percent Daily Value above and below it, as shown in
paragraph (d)(12) of this section.
(2) The information shall be presented under the identifying
heading of ``Nutrition Facts'' in the nutrition label and, except for
labels presented according to the format provided for in paragraphs
(d)(11)(iii), (d)(13)(ii), (e)(6)(ii), (j)(13)(ii)(A)(1), and
(j)(13)(ii)(A)(2) of this section, unless impractical, shall be set the
full width of the information provided under paragraph (d)(7) of this
section, as shown in paragraph (d)(12) of this section.
(3) * * *
(i) ``----servings per container'': The number of servings per
container, except that this statement is not required on single serving
containers as defined in paragraph (b)(6) of this section or on other
food containers when this information is stated in the net quantity of
contents declaration. The information required in this paragraph shall
be highlighted in bold or extra bold and be in a type size no smaller
than 11 point except the type size shall be no smaller than 10 point
for this information as shown in paragraph (j)(13)(ii)(A)(1) and no
smaller than 7 point as shown in paragraph (j)(13)(ii)(A)(2) of this
section. This information shall be set the full width of the label as
shown in paragraph (d)(12) of this section.
(ii) ``Serving size'': A statement of the serving size as specified
in paragraph (b)(7) of this section. The serving size as specified in
paragraph (b)(7) of this section must be right justified as shown in
paragraph (d)(12) of this section. The information required in this
paragraph shall be in a type size no smaller than 8 point except the
type size shall be no smaller than 7 point for this information as
shown in paragraph (j)(13)(ii)(A)(2) of this section.
(4) A subheading ``Amount per'' followed by the serving size shall
be separated from the serving size information by a bar as shown in
paragraph (d)(12) of this section and shall be highlighted in a type
that is intermediate between bold or extra bold type and the type for
all other information, and be in a type size no smaller than 8 point,
except the type size for this information required in the linear
display for small packages as shown in paragraph (j)(13)(ii)(A)(2) and
the tabular display for small packages as shown in paragraph
(j)(13)(ii)(A)(1) of this section shall be no smaller than 6 point, and
there shall be no bar separating this information from the serving size
information in both of these displays for small packages.
(5) Information on calories shall immediately follow the heading
``Amount per'' followed by the serving size and shall be declared in
one line. If ``Calories from saturated fat'' is declared, it shall be
indented under ``Calories'' and shall be in a type size no smaller than
8 point.
(6) The column heading ``% DV,'' followed by an asterisk (e.g., ``%
DV*''), shall be separated from information on calories by a bar as
shown in paragraph (d)(12) of this section. The position of this column
heading shall allow for a list of nutrient names and amounts as
described in paragraph (d)(7) of this section to be to the right of,
and below, this column heading, except for labels with a dual or
multiple column format as shown in paragraphs (d)(13)(ii), (e)(5),
(e)(6)(i), and (e)(6)(ii) the ``% DV'' column will appear to the right
of the list of nutrient names. The column heading described in this
paragraph shall not appear on the linear display for small packages as
shown in paragraph (j)(13)(ii)(A)(2) of this section.
(7) Except as provided for in paragraphs (d)(13)(ii), (e)(5),
(e)(6)(i), (e)(6)(ii), and (j)(13) of this section, nutrient
information for both mandatory and any voluntary nutrients listed in
paragraph (c) of this section that are to be declared in the nutrition
label shall be declared as follows:
(i) The name of each nutrient, as specified in paragraph (c) of
this section, shall be given in a column and followed immediately by
the quantitative amount by weight for that nutrient appended with a
``g'' for grams, ``mg'' for milligrams, or ``mcg'' for micrograms as
shown in paragraph (d)(12) of this section. The symbol ``>'' may be
used in place of ``less than.''
(ii) A listing of the percent of the DRV as established in
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a
column aligned under the heading ``% DV'' established in paragraph
(d)(6) of this section with the percent expressed to the nearest whole
percent for each nutrient declared in the column described in paragraph
(d)(7)(i) of this section for which a DRV has been established, except
that the percent for protein may be omitted as provided in paragraph
(c)(7) of this section. The percent shall be calculated by dividing
either the amount declared on the label for each nutrient or the actual
amount of each nutrient (i.e., before rounding) by the DRV for the
nutrient, except that the percent for protein shall be

[[Page 11973]]

calculated as specified in paragraph (c)(7)(ii) of this section. The
numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals (except sodium)
shall be separated from information on other nutrients by a bar and may
be arrayed vertically as shown in paragraph (d)(12) of this section
(e.g., Vitamin D 2mcg (10%), Calcium 260mg (20%), Iron 8mg (45%),
Potassium 235mg (5%)) or may be listed in two columns. When listed
horizontally in two columns, vitamin D and calcium should be listed on
the first line and iron and potassium should be listed on the second
line.
(9) [Reserved]
(10) Caloric conversion information on a per gram basis for fat,
carbohydrate, and protein may be presented beneath the information
required in the footnote statement, separated from that information by
a hairline. This information may be presented horizontally as shown in
paragraph (d)(12) of this section (i.e. ``Calories per gram: fat 9,
carbohydrate 4, protein 4'') or vertically in columns.
(11)(i) If the space beneath the information on vitamins and
minerals is not adequate to accommodate the information required in the
footnote statement, the information required in the footnote statement
may be moved to the right of the column required in paragraph
(d)(7)(ii) of this section and set off by a line that distinguishes it
and sets it apart from the percent Daily Value information. The caloric
conversion information provided for in paragraph (d)(10) of this
section may be presented beneath either side or along the full length
of the nutrition label.
(ii) If the space beneath the mandatory declaration of potassium is
not adequate to accommodate any remaining vitamins and minerals to be
declared or the information required in the footnote statement, the
remaining information may be moved to the right and set off by a line
that distinguishes it and sets it apart from the nutrients and the
percent DV information given to the left. The caloric conversion
information provided for in paragraph (d)(10) of this section may be
presented beneath either side or along the full length of the nutrition
label.
(iii) If there is not sufficient continuous vertical space (i.e.,
approximately 3 in) to accommodate the required components of the
nutrition label up to and including the mandatory declaration of
potassium, the nutrition label may be presented in a tabular display as
shown in the following sample label.
[GRAPHIC] [TIFF OMITTED] TP03MR14.003

(12) The following sample labels illustrate the mandatory
provisions and mandatory plus voluntary provisions of paragraph (d) of
this section.

[[Page 11974]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.004

(13) * * *
(ii) Aggregate displays shall comply with the format requirements
of paragraph (d) of this section to the maximum extent possible, except
that the identity of each food shall be specified immediately to the
right of the ``Nutrition Facts'' heading, and both the quantitative
amount by weight (i.e., g/mg/mcg amounts) and the percent Daily Value
for each nutrient shall be listed in separate columns under the name of
each food. The following sample label illustrates an aggregate display.

[[Page 11975]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.005

* * * * *
(e) Nutrition information may be presented for two or more forms of
the same food (e.g., both ``as purchased'' and ``as prepared'') or for
common combinations of food as provided for in paragraph (h)(4) of this
section, for different units (e.g., slices of bread or per 100 grams)
as provided for in paragraph (b) of this section, or for two or more
groups for which RDIs are established (e.g., both infants 7 through 12
months and children 1 through 3 years of age) as shown in paragraph
(e)(5) of this section. When such dual labeling is provided, equal
prominence shall be given to both sets of values. Information shall be
presented in a format consistent with paragraph (d) of this section,
except that:
(1) Following the serving size information there shall be two or
more column headings accurately describing the amount per serving size
of the form of the same food (e.g., ``Per \1/4\ cup mix'' and ``Per
prepared portion''), the combinations of food, the units, or the RDI
groups that are being declared as shown in paragraph (e)(5) of this
section.
(2) The information required in paragraph (d)(7)(ii) and the
quantitative information by weight as required in paragraph (d)(7)(i)
of this section shall be presented for the form of the product as
packaged and for any other form of the product (e.g., ``as prepared''
or combined with another ingredient as shown in paragraph (e)(5) of
this section).
(3) When the dual labeling is presented for two or more forms of
the same food, for combinations of food, for different units, or for
two or more groups for which RDIs are established, the percent DV and
quantitative information shall be separated by vertical lines as shown
in paragraph (e)(5) of this section.
(4) Nutrient information for vitamins and minerals (except sodium)
shall be separated from information on other nutrients by a bar and
shall be arrayed vertically in the following order: Vitamin D, calcium,
iron, potassium as shown in paragraph (e)(5) of this section.
(5) The following sample label illustrates the provisions of
paragraph (e) of this section:
[GRAPHIC] [TIFF OMITTED] TP03MR14.006

(6) When dual labeling is presented for a food on a per serving
basis and per container basis as required in paragraph (b)(12)(i) of
this section or on a per serving basis and per unit basis as required
in paragraph (b)(2)(i)(D) of this section, the percent Daily Value as
required in paragraph (d)(7)(ii) and the quantitative information by
weight shall be presented in two columns, and the percent DV and
quantitative information shall be separated by vertical lines as

[[Page 11976]]

shown in the displays in paragraph (e)(6)(i) of this section.
(i) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed vertically in the following order: Vitamin D, calcium, iron,
and potassium as shown in the following sample labels.
[GRAPHIC] [TIFF OMITTED] TP03MR14.007

(ii) The following sample label illustrates the provisions of
paragraphs (b)(2)(i)(D) and (b)(12)(i) of this section for labels that
use the tabular display.
[GRAPHIC] [TIFF OMITTED] TP03MR14.008

(f) The declaration of nutrition information may be presented in
the simplified format set forth herein when a food product contains
insignificant amounts of eight or more of the following: Calories,
total fat, saturated fat, trans fat, cholesterol, sodium, total
carbohydrate, dietary fiber, sugars, added sugars, protein, vitamin D,
calcium, iron, and potassium; except that for foods intended for
infants 7 months to 12 months of age and children 1 through 3 years of
age to which paragraph (j)(5)(i) of this section applies, nutrition
information may be presented in the simplified format when a food
product contains insignificant amounts of six or more of the following:
Calories, total fat, sodium, total carbohydrate, dietary fiber, sugars,
added sugars, protein, vitamin D, calcium, iron, and potassium.
* * * * *
(2) * * *
(ii) Any other nutrients identified in paragraph (f) of this
section that are present in the food in more than insignificant
amounts; and
* * * * *
(4) If any nutrients are declared as provided in paragraphs
(f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the
simplified format or if any nutrition claims are made on the label or
in labeling, the statement ``Not a significant source of ------'' (with
the blank filled in with the name(s) of any nutrient(s) identified in
paragraph (f) of this section that are present in insignificant
amounts) shall be included at the bottom of the nutrition label.

[[Page 11977]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.009

(5) Except as provided for in paragraphs (j)(5) and (j)(13) of this
section, nutrient information declared in the simplified format shall
be presented in the same manner as specified in paragraphs (d) or (e)
of this section.
(g) Compliance with this section shall be determined as follows:
* * * * *
(2) The sample for nutrient analysis shall consist of a composite
of 12 subsamples (consumer units), taken 1 from each of 12 different
randomly chosen shipping cases, to be representative of a lot. Unless a
particular method of analysis is specified in paragraph (c) of this
section, composites shall be analyzed by appropriate methods as given
in the ``Official Methods of Analysis of the AOAC International,'' 19th
Ed. (2012), which is incorporated by reference in accordance with 5
U.S.C. 552(a) or 1 CFR part 51 or, if no AOAC method is available or
appropriate, by other reliable and appropriate analytical procedures.
The availability of this incorporation by reference is given in
paragraph (c)(7) of this section.
(3) * * *
(ii) Class II. Naturally occurring (indigenous) nutrients. When a
nutrient or nutrients are naturally occurring (indigenous) in an
ingredient that is added to a food, the total amount of such
nutrient(s) in the final food product is subject to class II
requirements, except that when a nutrient or nutrients are not
naturally occurring (exogenous) in an ingredient that is added to a
food, the total amount of such nutrient(s) in the final food product is
subject to class I requirements.
(4) A food with a label declaration of a vitamin, mineral, protein,
total carbohydrate, dietary fiber, soluble fiber, insoluble fiber,
polyunsaturated or monounsaturated fat shall be deemed to be misbranded
under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the
act) unless it meets the following requirements:
(i) When a vitamin, mineral, protein, or non-digestible
carbohydrate(s) (when the food contains only non-digestible
carbohydrates (soluble or insoluble) that meet the definition of
dietary fiber) meets the definition of a Class I nutrient, the nutrient
content of the composite must be formulated to be at least equal to the
value for that nutrient declared on the label.
(ii) When a vitamin, mineral, protein, total carbohydrate,
polyunsaturated or monounsaturated fat, or non-digestible
carbohydrate(s) (when the food contains only non-digestible
carbohydrates (soluble or insoluble) that meet the definition of
dietary fiber) meets the definition of a Class II nutrient, the
nutrient content of the composite must be at least equal to 80 percent
of the value for that nutrient declared on the label. No regulatory
action will be based on a determination of a nutrient value that falls
below this level by a factor less than the variability generally
recognized for the analytical method used in that food at the level
involved.
(5) A food with a label declaration of calories, sugars, added
sugars (when the only source of sugars in the food is added sugars),
total fat, saturated fat, trans fat, cholesterol, or sodium shall be
deemed to be misbranded under section 403(a) of the act if the nutrient
content of the composite is greater than 20 percent in excess of the
value for that nutrient declared on the label. No regulatory action
will be based on a determination of a nutrient value that falls above
this level by a factor less than the variability generally recognized
for the analytical method used in that food at the level involved.
(6) Reasonable excesses of vitamins, minerals, protein, total
carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugar
alcohols, polyunsaturated or monounsaturated fat over labeled amounts
are acceptable within current good manufacturing practice. Reasonable
deficiencies of calories, sugars, added sugars, total fat, saturated
fat, trans fat, cholesterol, or sodium under labeled amounts are
acceptable within current good manufacturing practice.
(7) Compliance will be based on the metric measure specified in the
label statement of the serving size.
(8) Alternatively, compliance with the provisions set forth in
paragraphs (g)(1) through (g)(6) of this section may be provided by use
of an FDA approved database that has been computed following FDA
guideline procedures and where food samples have been handled in
accordance with current good manufacturing practice to prevent
nutrition loss. FDA approval of a database shall not be considered
granted until the Center for Food Safety and Applied Nutrition has
agreed to all aspects of the database in writing. The approval will be
granted where a clear need is presented (e.g., raw produce and
seafood). Approvals will be in effect for a limited time, e.g., 10
years, and will be eligible for renewal in the absence of significant
changes in agricultural or industry practices. Approval requests shall
be submitted in accordance with the provisions of Sec. 10.30 of this
chapter. Guidance in the use of databases may be found in the ``FDA
Nutrition Labeling Manual--A Guide for Developing and Using Data
Bases,'' available from the Office of Nutrition, Labeling, and Dietary
Supplements (HFS-800), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740 or by going to https://www.fda.gov.
* * * * *
(10) The manufacturer must make and keep written records (e.g.,
analyses of databases, recipes, formulations, or batch records) to
verify the declared amount of that nutrient on the Nutrition Facts
label as follows:
(i) When a mixture of dietary fiber, and added non-digestible
carbohydrate(s) that does not meet the definition of dietary fiber, is
present in the food, a manufacturer must make and keep written records
of the amount of non-digestible carbohydrate(s) added to the food that
does not meet the definition of dietary fiber.
(ii) When a mixture of soluble fiber and added non-digestible
carbohydrate(s) that does not meet the definition of dietary fiber is
present in the food, a manufacturer must make and keep written records
necessary to verify the amount of the non-digestible carbohydrate(s)
added to the food that does not meet the definition of dietary fiber.
(iii) When a mixture of insoluble fiber and added non-digestible
carbohydrate(s) that does not meet the definition of dietary fiber is
present in the food, a manufacturer must make and keep written records
necessary to verify the amount of the non-digestible carbohydrate(s)
added to the food that does not meet the definition of dietary fiber.
(iv) When a mixture of naturally occurring and added sugars is
present in

[[Page 11978]]

the food, a manufacturer must make and keep written records of the
amount of added sugars added to the food during the processing of the
food, and if packaged as a separate ingredient, as packaged (whether as
part of a package containing one or more ingredients or packaged as a
single ingredient).
(v) When the amount of added sugars added to yeast-leavened bakery
products, wines with less than 7 percent alcohol by volume, or beer
that does not meet the definition of a ``malt beverage,'' as defined by
the Federal Alcohol Administration Act (27 U.S.C. 211(a)(7)), is
reduced through the process of fermentation, manufacturers must:
(A) Make and keep records of all relevant scientific data and
information relied upon by the manufacturer that demonstrates the
amount of added sugars in the food after fermentation and a narrative
explaining why the data and information are sufficient to demonstrate
the amount of added sugars declared in the finished food, provided the
data and information used is specific to the type of fermented food
manufactured; or
(B) Make and keep records of the amount of added sugars added to
the food before and during the processing of the food, and if packaged
as a separate ingredient, as packaged (whether as part of a package
containing one or more ingredients or packaged as a single ingredient)
and in no event shall the amount of added sugars declared exceed the
amount of total sugars on the label.
(vi) When a mixture of all rac-[alpha]-tocopherol acetate and RRR-
[alpha]-tocopherol is present in a food, manufacturers must make and
keep written records of the amount of all rac-[alpha]-tocopherol
acetate added to the food and RRR-[alpha]-tocopherol in the finished
food.
(vii) When a mixture of folate and folic acid is present in a food,
manufacturers must make and keep written records of the amount of folic
acid added to the food and folate in the finished food.
(11) Records necessary to verify certain nutrient declarations that
are specified in paragraph (g)(10) of this section must be kept for a
period of at least 2 years after introduction or delivery for
introduction of the food into interstate commerce. Such records must be
provided to FDA upon request, during an inspection, for official review
and photocopying or other means of reproduction. Records required to
verify information on the label may be kept either as original records,
true copies (such as photocopies, pictures, scanned copies, microfilm,
microfiche, or other accurate reproductions of the original records),
or electronic records which must be kept in accordance with part 11 of
this chapter. These records must be accurate, indelible, and legible.
Failure to make and keep the records or provide the records to
appropriate regulatory authorities, as required by this subparagraph,
would result in the food being misbranded under section 403(a)(1) of
the act.
(h) * * *
(3) * * *
(iv) Nutrition information may be provided per serving for
individual foods in the package, or, alternatively, as a composite per
serving for reasonable categories of foods in the package having
similar dietary uses and similar significant nutritional
characteristics. Reasonable categories of foods may be used only if
accepted by FDA. In determining whether a proposed category is
reasonable, FDA will consider whether the values of the characterizing
nutrients in the foods proposed to be in the category meet the
compliance criteria set forth in paragraphs (g)(3) through (g)(6) of
this section. Proposals for such categories may be submitted in writing
to the Office of Nutrition, Labeling and Dietary Supplements (HFS-800),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
* * * * *
(4) If a food is commonly combined with other ingredients or is
cooked or otherwise prepared before eating, and directions for such
combination or preparations are provided, another column of figures may
be used to declare nutrition information on the basis of the food as
consumed in the format required in paragraph (e) of this section; e.g.,
a dry ready-to-eat cereal may be described with the percent Daily Value
and the quantitative amounts for the cereal as sold (e.g., per ounce),
and the percent Daily Value and the quantitative amounts for the cereal
and milk as suggested in the label (e.g., per ounce of cereal and \1/2\
cup of vitamin D fortified skim milk); and a cake mix may be labeled
with the percent Daily Value and the quantitative amounts for the dry
mix (per serving) and the percent Daily Value and the quantitative
amounts for the serving of the final cake when prepared, as shown in
paragraph (e)(5): Provided, that, the type and quantity of the other
ingredients to be added to the product by the user and the specific
method of cooking and other preparation shall be specified prominently
on the label.
* * * * *
(j) * * *
(5)(i) Foods, other than infant formula, represented or purported
to be specifically for infants 7 through 12 months and children 1
through 3 years of age shall bear nutrition labeling. The nutrients
declared for infants 7 through 12 months and children 1 through 3 years
of age shall include calories, total fat, saturated fat, trans fat,
cholesterol, sodium, total carbohydrates, dietary fiber, sugars, added
sugars, protein, and the following vitamins and minerals: Vitamin D,
calcium, iron, and potassium.
[GRAPHIC] [TIFF OMITTED] TP03MR14.010

(ii) Foods other than infant formula, represented or purported to
be specifically for infants 7 through 12 months of age shall bear
nutrition labeling, except that:
(A) Such labeling shall not declare a percent Daily Value for
saturated fat, trans fat, cholesterol, sodium, dietary fiber, sugars,
or added sugars.
* * * * *
(13) * * *
(ii) * * *
(A) * * *.
(1) The following sample label illustrates the tabular display for
small packages.

[[Page 11979]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.011

(2) The following sample label illustrates the linear display.
[GRAPHIC] [TIFF OMITTED] TP03MR14.012

(B) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carbs
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc

(C) Omitting the footnote statement and placing another asterisk at
the bottom of the label followed by the statement ``Percent Daily
Values are based on a 2,000 calorie diet.''
* * * * *
(18) * * *
(iv) A notice shall be filed with the Office of Nutrition,
Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740 and contain the following information,
except that if the person is not an importer and has fewer than 10
full-time equivalent employees, that person does not have to file a
notice for any food product with annual sales of fewer than 10,000
total units:
* * * * *
0
3. In Sec. 101.36:
0
a. Revise paragraphs (b)(1)(i), (b)(2)(i) introductory text,
(b)(2)(i)(B), (b)(2)(ii)(A), (b)(2)(iii) introductory text,
(b)(2)(iii)(D) through (G), (b)(3)(ii)(A), (c)(4), (e) introductory
text, (e)(8), (e)(11)(i) through (viii), (e)(12), (f)(2), and (i)(1);
and
0
b. Remove paragraph (i) introductory text.
The revisions read as follows:

Sec. 101.36 Nutrition labeling of dietary supplements.

* * * * *
(b) * * *
(1) Serving size. (i) The subheading ``Serving Size'' shall be
placed under the heading ``Supplement Facts'' and aligned on the left
side of the nutrition label. The subheading ``Servings Per Container''
and the actual number of servings shall be highlighted in bold or extra
bold type. The serving size shall be determined in accordance with
Sec. Sec. 101.9(b) and 101.12(b), table 2. Serving size for dietary
supplements shall be expressed using a term that is appropriate for the
form of the supplement, such as ``tablets,'' ``capsules,'' ``packets,''
or ``teaspoonfuls.''
* * * * *
(2) * * * (i) The (b)(2)-dietary ingredients to be declared, that
is, total calories, total fat, saturated fat, trans fat, cholesterol,
sodium, total carbohydrate, dietary fiber, sugars, added sugars,
protein, vitamin D, calcium, iron, and potassium, shall be declared
when they are present in a dietary supplement in quantitative amounts
by weight that exceed the amount that can be declared as zero in
nutrition labeling of foods in accordance with Sec. 101.9(c). Calories
from saturated fat, polyunsaturated fat, monounsaturated fat, soluble
fiber, insoluble fiber, and sugar alcohol may be declared, but they
shall be declared when a claim is made about them. Any (b)(2)-dietary
ingredients that are not present, or that are present in amounts that
can be declared as zero in Sec. 101.9(c), shall not be declared (e.g.,
amounts corresponding to less than 2 percent of the RDI for vitamins
and minerals). Protein shall not be declared on labels of products
that, other than ingredients added solely for technological reasons,
contain only individual amino acids.
* * * * *
(B) The names of dietary ingredients that are declared under
paragraph (b)(2)(i) of this section shall be presented in a column
aligned on the left side of the nutritional label in the order and
manner of indentation specified in Sec. 101.9(c), except that calcium
and iron shall follow pantothenic acid, and sodium and potassium shall
follow chloride. This results in the following order for vitamins and
minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K,
thiamin, riboflavin, niacin, vitamin B6, folic acid, vitamin
B12, biotin, pantothenic acid, calcium, iron, phosphorous,
iodine, magnesium, zinc, selenium, copper, manganese, chromium,
molybdenum, chloride, sodium, potassium, and choline. The (b)(2)-
dietary ingredients shall be listed according to the nomenclature
specified in Sec. 101.9 or in paragraph (b)(2)(i)(B)(2) of this
section.
(1) When ``Calories'' are declared, they shall be listed first in
the column of names, beneath a light bar separating the heading
``Amount Per Serving'' from the list of names. When ``Calories from
saturated fat'' are declared, they shall be indented under
``Calories.''
(2) The following synonyms may be added in parentheses immediately
following the name of these (b)(2)-dietary ingredients: Vitamin C
(ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin
B2), and calories (energy). Energy content per serving may
be expressed in kilojoule units, added in parentheses immediately
following the statement of caloric content.
(3) Beta-carotene may be declared as the percent of vitamin A that
is present as beta-carotene, except that the

[[Page 11980]]

declaration is required when a claim is made about beta-carotene. When
declared, the percent shall be declared to the nearest whole percent,
immediately adjacent to or beneath the name vitamin A (e.g., ``Vitamin
A (90% as beta-carotene)''). The amount of beta-carotene in terms of
micrograms (mcg) may be included in the parentheses following the
percent statement (e.g., ``Vitamin A (90% (810 mcg) as beta-
carotene)'').
(ii) * * *
(A) The amounts shall be expressed in the increments specified in
Sec. 101.9(c)(1) through (c)(7), which includes increments for sodium.
* * * * *
(iii) The percent of the Daily Value of all dietary ingredients
declared under paragraph (b)(2)(i) of this section shall be listed,
except that the percent of the Daily Value for protein may be omitted
as provided in Sec. 101.9(c)(7); no percent of the Daily Value shall
be given for subcomponents for which DRVs or RDIs have not been
established (e.g., sugars).
* * * * *
(D) If the percent of Daily Value is declared for total fat,
saturated fat, total carbohydrate, dietary fiber, or protein, a symbol
shall follow the value listed for those nutrients that refers to the
same symbol that is placed at the bottom of the nutrition label, below
the bar required under paragraph (e)(6) of this section and inside the
box, that is followed by the statement ``Percent Daily Values are based
on a 2,000 calorie diet.'' If the product is represented or purported
to be for use by children 1 through 3 years of age, and if the percent
of Daily Value is declared for total fat, total carbohydrate, dietary
fiber, or protein, a symbol shall follow the value listed for those
nutrients that refers to the same symbol that is placed at the bottom
of the nutrition label, below the bar required under paragraph (e)(6)
of this section and inside the box, that is followed by the statement
``Percent Daily Values are based on a 1,000 calorie diet.''
(E) The percent of Daily Value shall be based on RDI or DRV values
for adults and children 4 or more years of age, unless the product is
represented or purported to be specifically for infants 7 through 12
months of age, children 1 through 3 years of age, or pregnant and
lactating women, in which case the column heading shall clearly state
the intended group. If the product is for persons within more than one
group, the percent of Daily Value for each group shall be presented in
separate columns as shown in paragraph (e)(11)(ii) of this section.
(F) For declared subcomponents that have no DRVs or RDIs, a symbol
(e.g., an asterisk) shall be placed in the ``Percent Daily Value''
column that shall refer to the same symbol that is placed at the bottom
of the nutrition label, below the last heavy bar and inside the box,
and followed by a statement ``Daily Value not established.''
(G) When calories or calories from saturated fat are declared, the
space under the ``% DV'' column shall be left blank for these items.
When there are no other (b)(2)-dietary ingredients listed for which a
value must be declared in the ``% DV'' column, the column may be
omitted as shown in paragraph (e)(11)(vii) of this section. When the
``% DV'' column is not required, but the dietary ingredients listed are
subject to paragraph (b)(2)(iii)(F) of this section, the symbol
required in that paragraph shall immediately follow the quantitative
amount by weight for each dietary ingredient listed under ``Amount Per
Serving.''
(3) * * *
(ii) * * *
(A) These amounts shall be expressed using metric measures in
appropriate units.
* * * * *
(c) * * *
(4) The sample label shown in paragraph (e)(11)(v) of this section
illustrates one method of nutrition labeling a proprietary blend of
dietary ingredients.
* * * * *
(e) Except as provided for small and intermediate sized packages
under paragraph (i)(2) of this section, information other than the
title, headings, and footnotes shall be in uniform type size no smaller
than 8 point. A font size at least two points greater shall be used for
``Calories'' and the heading ``Calories'' and the actual number of
calories per serving shall be highlighted in bold or extra bold type.
Type size no smaller than 6 point may be used for column headings
(e.g., ``Amount Per Serving'' and ``% Daily Value'') and for footnotes
(e.g., ``Percent Daily Values are based on a 2,000 calorie diet).
* * * * *
(8) If the product contains two or more separately packaged dietary
supplements that differ from each other (e.g., the product has a packet
of supplements to be taken in the morning and a different packet to be
taken in the afternoon), the quantitative amounts and percent of Daily
Value may be presented as specified in this paragraph in individual
nutrition labels or in one aggregate nutrition label as illustrated in
paragraph (e)(11)(iii) of this section.
* * * * *
(11) * * *
BILLING CODE 4160-01-P
(l) Multiple vitamins

[[Page 11981]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.013

[[Page 11982]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.014

[[Page 11983]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.015

[[Page 11984]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.016

[[Page 11985]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.017

(12) If space is not adequate to list the required information as
shown in the sample labels in paragraph (e)(11) of this section, the
list may be split and continued to the right as long as the headings
are repeated. The list to the right must be set off by a line that
distinguishes it and sets it apart from the dietary ingredients and
percent of Daily Value information given to the left. The following
sample label illustrates this display:

[[Page 11986]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.018

BILLING CODE 4160-01-C
(f) * * *
(2) When it is not technologically feasible, or some other
circumstance makes it impracticable, for firms to comply with the
requirements of this section, FDA may permit alternative means of
compliance or additional exemptions to deal with the situation in
accordance with Sec. 101.9(g)(9). Firms in need of such special
allowances shall make their request in writing to the Office of
Nutrition, Labeling and Dietary Supplements (HFS-800), Food and Drug

[[Page 11987]]

Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
* * * * *
(i)(1) Dietary supplements are subject to the special labeling
provisions specified in Sec. 101.9(j)(5)(i) for foods other than
infant formula, represented or purported to be specifically for infants
and children less than 2 years of age.
* * * * *

Dated: February 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04387 Filed 2-27-14; 8:45 am]
BILLING CODE 4160-01-C

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.