Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Draft Guidance for Industry; Availability, 1347-1348 [2016-32005]

Download as PDF Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices mstockstill on DSK3G9T082PROD with NOTICES brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 17, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 21, 2017. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA is establishing a docket for public comment on this document. The docket number is FDA–2016–N–0567. The docket will close on February 17, 2017. Comments received on or before February 17, 2017 will be provided to the committee. Comments received after the date will be taken into consideration by the Agency. For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301– 796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Marieann Brill at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–32019 Filed 1–4–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–4414] Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. Notification of availability with request for comments. ACTION: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ‘‘Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.’’ The draft guidance, when finalized, will provide questions and answers on topics related to compliance, labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format for Nutrition and Supplement Facts labels. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 6, 2017. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 1347 comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–D–4414 for ‘‘Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ E:\FR\FM\05JAN1.SGM 05JAN1 1348 Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper 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. Submit written requests for single copies of the draft guidance to the Office of Nutrition and Food Labeling/ Nutrition Programs Staff, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS–830), 5001 Campus Dr., College Park, MD 20740, 240–402–5429. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with NOTICES I. Background We are announcing the availability of a draft guidance for industry entitled ‘‘Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.’’ We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. In the Federal Register of May 27, 2016, we issued a final rule entitled ‘‘Food Labeling: Revision of the Nutrition and Supplement Facts Labels’’ (81 FR 33742). The final rule amends our regulations for the nutrition labeling of conventional foods and dietary supplements to provide updated nutrition information and to improve VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 how the nutrition information is presented to consumers. The final rule provided two compliance dates distinguishing between manufacturers with $10 million or more in annual food sales (July 26, 2018) and manufacturers with less than $10 million in annual food sales (July 26, 2019). The final rule also revised the Nutrition Facts label to replace ‘‘sugars’’ with ‘‘total sugars’’ and to include the declaration of added sugars. The draft guidance is intended for conventional food and dietary supplement manufacturers and will, when finalized, provide questions and answers on topics related to compliance, labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format. II. Additional Issues for Consideration We invite interested persons to comment on topics related to compliance, labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format. However, we are particularly interested in responses to the following questions: 1. What, if any, concerns are there for manufacturers to use Brix values from 21 CFR 101.30 when calculating the added sugars content of products containing fruit juice concentrates? 2. For purposes of calculating the amount of added sugars, what, if any, concerns are there if we consider that all of the water in a formulation with fruit or vegetable juice concentrate is used to reconstitute the fruit or vegetable juice? To illustrate the issue, assume that fruit juice concentrate is added to a food and that the manufacturer also adds water to the food. We recognize that the water may reconstitute the fruit juice, but also recognize that some portion of the water may have other purposes or affect ingredients other than the fruit juice concentrate. Nevertheless, to calculate the amount of added sugars, we would consider that all of the water goes towards reconstituting the fruit juice. 3. What, if any, concerns are there if we consider that all of the water that has been removed from a product during processing contributes towards the concentration of juice added as an ingredient during the formulation of the product? When responding to these questions, please explain your reasoning. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 3520). The collections of information in 21 CFR part 101 have been approved under OMB control number 0910–0813. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. V. Reference The following reference is on display in the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it are also available electronically at https:// www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. U.S. Department of Health and Human Services. 2015 Dietary Guidelines for Americans. Accessed online at https:// www.health.gov/dietaryguidelines/dga2005/ document/default.htm. Dated: December 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–32005 Filed 1–4–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0586] Food and Drug Administration Tribal Consultation Policy; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of the FDA Tribal Consultation Policy. The purpose of the FDA Tribal Consultation Policy is to further the government-togovernment relationship between FDA and American Indian and Alaskan Native Tribes (Indian Tribes) and facilitate tribal consultation with FDA. The FDA Tribal Consultation Policy provides background on FDA’s mission and organizational structure and elaborates on the principles and guidelines in the U.S. Department of Health and Human Services (HHS) Tribal Consultation Policy. This policy finalizes the draft FDA Tribal SUMMARY: E:\FR\FM\05JAN1.SGM 05JAN1

Agencies

[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1347-1348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-32005]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4414]

Questions and Answers on the Nutrition and Supplement Facts
Labels Related to the Compliance Date, Added Sugars, and Declaration of
Quantitative Amounts of Vitamins and Minerals; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability with request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Questions and
Answers on the Nutrition and Supplement Facts Labels Related to the
Compliance Date, Added Sugars, and Declaration of Quantitative Amounts
of Vitamins and Minerals.'' The draft guidance, when finalized, will
provide questions and answers on topics related to compliance, labeling
of added sugars, declaration of quantitative amounts of vitamins and
minerals, and format for Nutrition and Supplement Facts labels.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on the draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by
March 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-4414 for ``Questions and Answers on the Nutrition and
Supplement Facts Labels Related to the Compliance Date, Added Sugars,
and Declaration of Quantitative Amounts of Vitamins and Minerals.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential''

[[Page 1348]]

will not be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper 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.
Submit written requests for single copies of the draft guidance to
the Office of Nutrition and Food Labeling/Nutrition Programs Staff,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition, Food and Drug Administration (HFS-830),
5001 Campus Dr., College Park, MD 20740, 240-402-5429.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a draft guidance for industry
entitled ``Questions and Answers on the Nutrition and Supplement Facts
Labels Related to the Compliance Date, Added Sugars, and Declaration of
Quantitative Amounts of Vitamins and Minerals.'' We are issuing the
draft guidance consistent with our good guidance practices regulation
(21 CFR 10.115). The draft guidance, when finalized, will represent the
current thinking of FDA on this topic. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternate approach if it satisfies the requirements of the applicable
statutes and regulations.
In the Federal Register of May 27, 2016, we issued a final rule
entitled ``Food Labeling: Revision of the Nutrition and Supplement
Facts Labels'' (81 FR 33742). The final rule amends our regulations for
the nutrition labeling of conventional foods and dietary supplements to
provide updated nutrition information and to improve how the nutrition
information is presented to consumers. The final rule provided two
compliance dates distinguishing between manufacturers with $10 million
or more in annual food sales (July 26, 2018) and manufacturers with
less than $10 million in annual food sales (July 26, 2019). The final
rule also revised the Nutrition Facts label to replace ``sugars'' with
``total sugars'' and to include the declaration of added sugars. The
draft guidance is intended for conventional food and dietary supplement
manufacturers and will, when finalized, provide questions and answers
on topics related to compliance, labeling of added sugars, declaration
of quantitative amounts of vitamins and minerals, and format.

II. Additional Issues for Consideration

We invite interested persons to comment on topics related to
compliance, labeling of added sugars, declaration of quantitative
amounts of vitamins and minerals, and format. However, we are
particularly interested in responses to the following questions:
1. What, if any, concerns are there for manufacturers to use Brix
values from 21 CFR 101.30 when calculating the added sugars content of
products containing fruit juice concentrates?
2. For purposes of calculating the amount of added sugars, what, if
any, concerns are there if we consider that all of the water in a
formulation with fruit or vegetable juice concentrate is used to
reconstitute the fruit or vegetable juice? To illustrate the issue,
assume that fruit juice concentrate is added to a food and that the
manufacturer also adds water to the food. We recognize that the water
may reconstitute the fruit juice, but also recognize that some portion
of the water may have other purposes or affect ingredients other than
the fruit juice concentrate. Nevertheless, to calculate the amount of
added sugars, we would consider that all of the water goes towards
reconstituting the fruit juice.
3. What, if any, concerns are there if we consider that all of the
water that has been removed from a product during processing
contributes towards the concentration of juice added as an ingredient
during the formulation of the product?
When responding to these questions, please explain your reasoning.

III. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 101 have been approved under
OMB control number 0910-0813.

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

V. Reference

The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. U.S. Department of Health and Human Services. 2015 Dietary
Guidelines for Americans. Accessed online at https://www.health.gov/dietaryguidelines/dga2005/document/default.htm.

Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-32005 Filed 1-4-17; 8:45 am]
BILLING CODE 4164-01-P

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