Food Labeling: Revision of Reference Values and Mandatory Nutrients, 62149-62175 [07-5440]
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Federal Register / Vol. 72, No. 212 / Friday, November 2, 2007 / Proposed Rules
Authority: 26 U.S.C. 3304(a)(9)(B);
Secretary’s Order No. 3–2007, April 3, 2007
(72 FR 15907).
§ 616.5
[Removed]
2. Remove § 616.5.
3. Revise paragraph (e) of § 616.6 to
read as follows:
§ 616.6
Definitions.
*
*
*
*
*
(e) Paying State. A single State against
which the claimant files a CombinedWage Claim, if the claimant has wages
and employment in that State’s base
period(s) and the claimant qualifies for
unemployment benefits under the
unemployment compensation law of
that State using combined wages and
employment.
*
*
*
*
*
4. Add paragraph (f) to § 616.7 to read
as follows:
§ 617.7
Claim.
Election to file a Combined-Wage
*
*
*
*
*
(f) If a State denies a Combined-Wage
Claim, it must inform the claimant of
the option to file in another State in
which the State finds that claimant has
wages and employment during that
State’s base period(s).
§ 616.8
[Amended]
5. In § 616.8(a) remove the words ‘‘,
even if the Combined-Wage Claimant
has no earnings in covered employment
in that State’’.
Signed at Washington, DC, this 29th day of
October 2007.
Emily Stover DeRocco,
Assistant Secretary for Employment and
Training.
[FR Doc. E7–21513 Filed 11–1–07; 8:45 am]
BILLING CODE 4510–FW–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
RIN 0910–ZA30
[Docket No. 2006N–0168]
Food Labeling: Revision of Reference
Values and Mandatory Nutrients
AGENCY:
Food and Drug Administration,
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HHS.
Advance notice of proposed
rulemaking.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is issuing this
advance notice of proposed rulemaking
(ANPRM) to request comment on what
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new reference values the agency should
use to calculate the percent daily value
(DV) in the Nutrition Facts and
Supplement Facts labels and what
factors the agency should consider in
establishing such new reference values.
In addition, FDA requests comments on
whether it should require that certain
nutrients be added or removed from the
Nutrition Facts and Supplement Facts
labels. Comments on what factors
should be considered to update the
agency’s reference values will inform
any FDA rulemaking that may result
from this ANPRM.
DATES: Submit written or electronic
comments by January 31, 2008.
ADDRESSES: You may submit comments,
identified by Docket No. 2006N–0168,
by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal or the
agency Web site, as described in the
Electronic Submissions portion of this
paragraph.
Instructions: All submissions received
must include the agency name and
Docket No. and Regulatory Information
Number (RIN) for this rulemaking. All
comments received may be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, 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.fda.gov/ohrms/dockets/
default.htm and insert the docket
number, found in brackets in the
heading of this document, into the
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62149
‘‘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:
Paula R. Trumbo, Center for Food Safety
and Applied Nutrition (HFS–830), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–2579, or e-mail:
Paula.Trumbo@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Development of Current DVs
B. Nutrient Content Final Rule
C. Labeling of Dietary Supplements
D. IOM DRIs and Acceptable
Macronutrient Distribution Ranges
E. IOM Report on Guiding Principles
for Nutrition Labeling
F. IOM Report on the Definition of
Fiber
G. Current Regulations on Trans Fat
H. ANPRM on Prominence of Calories
I. Carbohydrate Content of Food
J. ‘‘2005 Dietary Guidelines for
Americans’’
II. Agency Request for Information
A. Approach for Setting DVs
B. Populations for Which the DVs are
Intended
C. Labeling of Individual Nutrients
D. Other Questions
E. Process Questions
F. Questions on Consumer and
Producer Use and Understanding of
DVs
III. Comments
IV. References
Appendix A Acronyms Used in This
Document
Appendix B Examples of Nutrition Facts
and Supplement Facts Labels
I. Background1
On November 8, 1990, the Nutrition
Labeling and Education Act (NLEA) of
1990 (Public Law No. 101–535) was
signed into law (the 1990 amendments)
amending the Federal Food, Drug, and
Cosmetic Act (the act). The 1990
amendments made the most significant
changes in the act and had a direct
bearing on FDA’s revision of nutrition
labeling in 1993. The 1990 amendments
added section 403(q) (21 U.S.C. 403(q))
to the act which specified, in part, that:
(1) With certain exceptions, a food is to
be considered misbranded unless its
label or labeling bears nutrition labeling;
(2) certain nutrients and food
components are to be included in
1A list of the acronyms cited in this ANPRM are
defined in Appendix A.
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nutrition labeling, although the
Secretary of Health and Human Services
can add or delete nutrients by regulation
if it is found necessary to assist
consumers in maintaining healthy
dietary practices; (3) nutrition labeling
is to be provided for the most frequently
consumed varieties of raw produce
(fruits and vegetables) and raw fish
according to voluntary guidelines or, if
necessary, regulations; (4) a simplified
nutrition label is to be used when the
food contains insignificant amounts of
most nutrients; and (5) FDA is to
develop regulations governing labeling
of foods to which section 411 of the act
(21 U.S.C. 350) applies (i.e., vitamin and
minerals).
In response to the NLEA, FDA, in
1993, issued several rules to modify
how nutrition information is presented
on food labels. When the agency issued
those rules to modify the nutrition label
information, it considered the diet and
health information that was current at
that time, including the National
Academy of Sciences (NAS)
Recommended Dietary Allowances
(RDAs) (Refs. 1 to 3), the NAS Diet and
Health Report (Ref. 4), the Surgeon
General’s Report on Nutrition and
Health (Ref. 5), and the 1990 Dietary
Guidelines for Americans (Ref. 6). New
information has since become available
on nutrient values that the agency
believes may impact what nutrients it
should consider requiring to be listed on
the food label and what nutrient values
it should use as a basis for the DVs on
the food label. The new information
includes revisions to the Dietary
Guidelines for Americans (Ref. 7), the
Institute of Medicine’s (IOM’s)
published reports on the Dietary
Reference Intakes (DRIs) that update
recommendations for the intake of
vitamins, minerals, and macronutrients
(Refs. 8 to 14), the IOM report on the
application of the DRIs (Ref. 15), and the
IOM report on ‘‘Guiding Principles for
Nutrition Labeling and Fortification’’
that provides recommendations on the
use of the new DRIs in nutrition labeling
(Ref. 16). The latter reports stimulated
extensive discussion in the scientific
community (e.g. at nutrition and food
science conferences and in publications
(Refs. 17 to 19); FDA and the IOM
recognize that the approach to setting a
DV in the labeling report (Ref. 16)
represents a new approach that requires
evaluation. At the IOM’s 2007 workshop
on ‘‘The Development of DRI’s 1994–
2004: Lessons Learned and New
Challenges,’’ there was discussion about
the limitations of the framework that
was used to set the DRIs, as well as
recommendations for future
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consideration. For all of these reasons,
FDA finds it important to seek comment
on the recommendations made in these
reports (Refs. 7 to 16). In addition, the
agency is considering changes to the
food label in more recently published
ANPRMs concerning prominence of
calories and the labeling of trans fats.
The agency discusses, below, the 1993
rules on food labeling, these ANPRMs,
and publications and reports available
since 1993, to provide background for
the questions the agency is asking in
this ANPRM related to a future
proposed rule to update the
presentation of nutrients and content of
nutrient values on food labels.
A. Development of Current DVs
In the final rule on Food Labeling;
Reference Daily Intakes and Daily
Reference Values (the 1993 RDI/DRV
final rule) (58 FR 2206, January 6, 1993),
FDA amended its regulations to
establish two sets of label reference
values: Reference Daily Intakes (RDIs)
and Daily Reference Values (DRVs) for
use in declaring the nutrient content of
a food on its label or labeling. These two
reference values were used to establish
a single set of label reference values
known as the DVs, which were intended
to assist consumers in both
understanding the relative significance
of nutritional information in the context
of a total daily diet and in comparing
the nutritional values of food products.
1. RDIs
In the Federal Register of July 19,
1990 (55 FR 29476), FDA proposed to
replace the U.S. Recommended Daily
Allowances (U.S. RDAs) as the reference
values for certain vitamins and minerals
used in nutrition labeling of foods with
updated and expanded reference values
(the 1990 proposal). The U.S. RDAs set
in 1973 were based primarily on the
NAS 1968 RDA values for vitamins and
minerals (Ref. 1). However, the U.S.
RDAs for certain vitamins and minerals
for which no RDA had been identified
(biotin, pantothenic acid, copper, and
zinc) were based on information cited in
the NAS’s ‘‘Recommended Dietary
Allowances,’’ 7th edition (Ref. 1). The
NAS RDAs were updated in 1974 and
1980, and again in 1989 along with
revised values for the listing known as
‘‘Estimated Safe and Adequate Daily
Dietary Intakes’’ (ESADDIs).2 In 1990,
FDA decided that it needed to update
2The ESADDIs are nutrient values set by NAS for
essential nutrients for which data are available to
estimate a range of requirements, but insufficient
for developing a specific RDA (Ref. 3).
3In 1993, FDA redesignated the term U.S. RDA to
RDI because the term U.S. RDA was easily confused
with the term RDA (58 FR 2206 at 2207).
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the U.S. RDA values, in part, due to the
revisions of the 1989 NAS RDA and
ESADDI values. FDA proposed to
redesignate ‘‘U.S. RDAs’’ as ‘‘RDIs,’’3
and to establish five sets of RDIs for
different developmental groups, i.e.,
adults and children 4 or more years of
age (excluding pregnant or lactating
women), children less than 4 years of
age, infants, pregnant women, and
lactating women. FDA also proposed
using a population-weighted average of
the relevant NAS RDAs and ESADDIs to
establish the RDIs because it would
‘‘serve the purpose of providing an
overall reference value for food labeling
more appropriately than a highest
value’’ and ‘‘because of decreasing
public health concern with nutritional
deficiencies, it makes less sense to use
maximum values as the basis for these
reference values’’ (55 FR 29476 at
29478).
In the 1993 RDI/DRV final rule, FDA
redesignated the U.S. RDA values in
part 101 (21 CFR part 101) for vitamins
and minerals as RDIs. In addition, FDA
established, under 21 CFR part 104, a
single set of label reference values for
adults and children 4 or more years of
age, in part, because of space constraints
on the food label and the fact that
children over the age of 4 years
consume the same foods that the rest of
the population consumes (58 FR 2206 at
2213). These RDIs were based on the
NAS RDAs set in 1968. Although FDA
proposed in 1990 to base the RDIs on a
population-weighted average of the
RDAs and ESADDIs, in the 1993 RDI/
DRV final rule FDA used the highest
RDA for adults and children 4 or more
years of age (excluding values for
pregnant and lactating women) to serve
as label reference values (58 FR 2206 at
2210 to 2213). FDA found that there was
considerable and uniform support in the
comments for continuing to select the
highest nutrient value from this group
and that vulnerable or at-risk groups
would be sufficiently covered by
electing the highest value. FDA referred
to this approach as the ‘‘populationcoverage approach.’’
On October 6, 1992, Congress passed
the Dietary Supplement Act of 1992
that, in section 203, instructed FDA to
not issue regulations before November
8, 1993, that would revise the U.S.
RDAs (redesignated as RDIs) for
vitamins or minerals (other than
existing regulations that established the
U.S. RDAs specified in § 101.9(c)(7)(iv)
that were in effect prior to October 6,
1992). Thus, FDA did not codify new
nutrient values in the 1993 RDI/DRV
final rule. In the Federal Register of
December 28, 1995 (60 FR 67164) (the
1995 final rule), FDA amended certain
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RDIs based on the 1989 NAS RDAs and
ESADDIs.
In the 1995 final rule, FDA amended
its regulations to establish RDIs for
vitamin K and selenium based on the
1989 NAS RDAs, and for manganese,
chromium, molybdenum, and chloride
based on the 1989 ESADDIs (Ref. 3).
FDA did not establish a DV for fluoride
in the 1995 final rule because the 1989
NAS RDA report stated that published
studies ‘‘do not justify a classification of
fluorine4 as an essential element,
according to accepted standards’’ (Ref. 3
at p. 235) and because the primary
sources of dietary fluoride (e.g.,
community water supplies, toothpastes,
mouth rinses) are not required to bear
nutrition labeling (60 FR 67164 at
67168). FDA concluded that the
declaration of percent DV of fluoride
within nutrition labeling on a limited
number of foods that are relatively
minor sources of the nutrient would be
of little use in assisting consumers in
maintaining healthy dietary practices
(60 FR 67164 at 67168).
In addition, a notification was
submitted under section 403(r)(2)(G) of
the act (21 U.S.C. 343(r)(2)(G)) in 2001
for the use of certain nutrient content
claims for choline. These statements
identify the daily value for choline as
550 milligrams (mg).5 This value is
based on the Adequate Intake (AI) set by
the Institute of Medicine (IOM) of the
NAS in 1998 (Refs. 9 and 20).
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2. DRVs
The 1993 RDI/DRV final rule also
identified DRVs for those nutrients that
are important to diet and health (e.g.,
total fat, saturated fat, cholesterol, total
carbohydrate (CHO), protein, dietary
fiber, sodium, and potassium). The
DRVs are based on the NAS Diet and
Health Report (sodium, potassium, fat,
saturated fat, cholesterol, carbohydrate,
and dietary fiber) (Ref. 4), the Surgeon
General’s Report on Nutrition and
Health (dietary fiber) (Ref. 5), and the
1990 Dietary Guidelines for Americans
(Ref. 6). The DRV for protein (50 grams
per day (g/d)) was set at 10 percent of
2,000 calories based on an adjusted
average of the 1989 RDA (Ref. 3). The
use of ‘‘calories’’ to mean ‘‘kilocalories’’
(kcals) is commonly accepted and more
readily understood by consumers.
The DRVs in the 1993 RDI/DRV final
rule (58 FR 2206) were based on a 2,000
4Fluoride is the ionized form of the element
fluorine.
5FDA has not acted to prohibit or modify the
claims, and therefore, manufacturers may use the
specified claims on the label and in the labeling of
any food or dietary supplement product that
qualifies for the claims described in the
notification.
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calorie reference diet. In the 1990
proposal (55 FR 29476 at 29482), FDA
proposed using a 2,350 calories
reference diet based on a population
adjusted mean of recommended calorie
allowances for persons 4 or more years
of age (excluding pregnant and lactating
women) (from table 3–5 of the 10th
edition of ‘‘Recommended Dietary
Allowances’’ (Ref. 3)). However, FDA
received several comments opposing the
2,350 reference values because of
concerns that this value was too high,
especially among women (58 FR 2206 at
2217). In addition, several comments
suggested that using 2,000 calories as a
reference diet would be easier for
consumers to use in calculations and
closer to caloric requirements of older
women who are ‘‘at risk for excessive
calories and fat’’ (id.). The 2,000 calorie
reference diet FDA adopted was
consistent with the ‘‘populationcoverage approach’’ as it selected a
lower calorie basis for the DRVs for the
group at risk (i.e., older women).
B. Nutrient Content Final Rule
In the Federal Register of January 6,
1993 (58 FR 2079), FDA published a
final rule entitled ‘‘Food Labeling:
Mandatory Status of Nutrition Labeling
and Nutrient Content Revision, Format
for Nutrition Label’’ (the 1993 nutrient
content final rule). The 1993 nutrient
content final rule: (1) Requires nutrition
labeling on most foods that are regulated
by FDA, (2) revises the list of required
nutrients and food components and the
conditions for declaring them in
nutrition labeling, (3) specifies a new
format for declaring nutrition
information, (4) allows specified
products to be exempt from nutrition
labeling, and (5) prescribes a simplified
form of nutrition labeling and the
circumstances in which such simplified
nutrition labeling can be used. An
example of a Nutrition Facts label can
be found in appendix B.
1. Required and Voluntary Labeling of
Nutrients on Food Products (§ 101.9(c))
With respect to nutrition labeling of
foods, the 1993 nutrient content final
rule declared that nutrition information
on the label and in labeling of foods
shall contain information about the
level of the following nutrients: (1)
Calories or total calories; (2) calories
from fat; (3) calories from saturated fat
(voluntary); (4) total fat; (5) saturated fat;
(6) polyunsaturated fat (voluntary); (7)
monounsaturated fat (voluntary); (8)
cholesterol; (9) sodium; (10) potassium
(voluntary); (11) total carbohydrate
(including sugars (mono- and
disaccharides), oligosaccharides, starch,
fiber, and organic acids); (12) dietary
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fiber; (13) soluble fiber (voluntary); (14)
insoluble fiber (voluntary); (15) sugars;
(16) sugar alcohol (voluntary); (17) other
carbohydrate (voluntary); (18) protein;
and (19) vitamins and minerals (see
§ 101.9(c)(1) through (c)(8)). However,
those nutrients that can be declared
voluntarily, as described previously in
this document, must be declared when
a nutrient content or health claim is
made (§ 101.9(c)). In the Federal
Register of July 11, 2003 (68 FR 41434),
FDA amended its regulations on
nutrition labeling to require trans fatty
acids be declared in grams per serving
in the nutrition label of conventional
foods and dietary supplements (see
section G).
Nutrient information for both
mandatory and any voluntary nutrients
that are to be declared in the nutrition
label, except vitamins and minerals,
shall be declared with the name of each
nutrient, and the quantitative amount by
weight for that nutrient (i.e. g or mg)
(see § 101.9(d)(7)(i)). A listing of the
percent DRV as established in
§ 101.9(c)(7)(iii) and (c)(9) (see table 1 of
this document for reference values) is
required under the heading percent DV
for each nutrient for which a DRV was
established, except that the percent for
protein may be omitted (see
§ 101.9(d)(7)(ii)).
The regulations require that
information about these nutrients be
declared on the nutrition label and that
no nutrients or food components, other
than those listed, may be included on
the nutrition label (§ 101.9(c)).
A statement about the percent of the
RDI, expressed as the percent of the DV
for vitamin A, vitamin C, calcium, and
iron, in that order, is required (see table
1 of this document for reference values)
(§ 101.9(c)(8)(ii)). These four vitamin
and mineral nutrients are required to be
declared because of public health
concerns relative to inadequate intake of
these nutrients by specific portions of
the population, as well as the possible
association between the lack of several
of these nutrients in the diet and the
risk of chronic disease (58 FR 2079 at
2106). The declaration of other vitamins
and minerals that have an RDI is
required when they are added as a
nutrient supplement or when a claim is
made about them (§ 101.9(c)(8)(ii)). If
the amount of the vitamin or mineral is
present at less than 2 percent of the RDI,
declaration of an amount is not required
or the content may be expressed as zero
(§ 101.9(c)(8)(iii)).
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TABLE 1.—REFERENCE VALUES FOR
NUTRITION LABELING (BASED ON A
2,000 CALORIE INTAKE; FOR ADULTS
AND CHILDREN 4 OR MORE YEARS
OF AGE)
Unit of
Measure
Nutrient1
Daily
Values
g
65
Saturated fatty
acids
g
20
Cholesterol
mg
300
Sodium
mg
2,400
Potassium
mg
3,500
Total carbohydrate
g
300
Fiber
g
25
Protein
g
50
Vitamin A
International
Units (IU)
5,000
Vitamin C
mg
60
Calcium
mg
1,000
Iron
mg
18
Vitamin D
IU
400
Vitamin E
IU
30
Vitamin K
micrograms
(µg)
80
Thiamin
mg
1.5
Riboflavin
mg
1.7
Niacin
mg
20
Vitamin B6
mg
2.0
Folate
µg
400
Vitamin B12
µg
6.0
Biotin
µg
300
Pantothenic
acid
mg
10
Phosphorus
mg
1,000
Iodine
µg
150
Magnesium
mg
400
Zinc
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Total Fat
mg
15
Selenium
µg
70
Copper
mg
2.0
Manganese
mg
2.0
Chromium
µg
120
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represented to be for use by infants,
children under 4 years of age, or
pregnant or lactating women, without
objection from FDA (58 FR 2206 at
2213). The RDIs for the vitamins and
minerals for these groups are listed in a
table in the 1993 RDI/DRV final rule as
Unit of
Daily
Nutrient1
guidance (58 FR 2206 at 2213). Such
Measure
Values
table does not include the seven
Molybdenum
µg
75
nutrients that FDA stated could not be
on conventional food labeling for these
Chloride
mg
3,400
specific groups in the 1995 final rule.
1Nutrients in this table are listed in the order
Section 101.9(c)(8)(i) states that all other
in which they are required to appear on a foods must use the RDI for adults and
label in accordance with § 101.9(c). This list children 4 or more years of age.
TABLE 1.—REFERENCE VALUES FOR
NUTRITION LABELING (BASED ON A
2,000 CALORIE INTAKE; FOR ADULTS
AND CHILDREN 4 OR MORE YEARS
OF AGE)—Continued
includes only those nutrients for which a DRV
has been established in § 101.9(c)(9) or a RDI
in § 101.9(c)(8)(iv).
The declaration of other vitamins and
minerals with an RDI need not be
declared if: (1) Neither the nutrient nor
the component is otherwise referred to
on the label or in labeling or advertising
and (2) the vitamins and minerals are
required or permitted in a standardized
food (e.g., thiamin, riboflavin, and
niacin in enriched flour) and included
in a food solely for technological
purposes and declared only in the
ingredient statement (§ 101.9(c)(8)(ii)).
Foods that are represented or purported
to be for use by infants (up to 12 months
of age), children 1 to 4 years of age,
pregnant women, or lactating women
must use the RDIs that are specified for
the intended group (§ 101.9(c)(8)(i)).
However, FDA has not codified RDI
values to use for these various groups.
FDA stated, in the 1995 final rule, that
it intended to address the issue of RDIs
for all nutrients for the various age
groups in a future rulemaking but was
not doing so in that rule due to the
continuing questions about how to
arrive at such values. FDA noted that,
for conventional foods, there could be
no declaration on labels of foods
represented or purported to be for use
by infants, children less than 4 years of
age, or pregnant or lactating women for
vitamin K, selenium, chloride,
manganese, chromium, and
molybdenum until such time as RDIs
are established for such groups (60 FR
67164 at 67171). FDA stated that these
six nutrients could be specified in mg or
µg amounts in dietary supplements
under § 101.36 with an asterisk in the
percent DV column that refers to a
footnote stating ‘‘Daily Value not
established.’’
Prior to the 1995 final rule, FDA
noted in the 1993 RDI/DRV final rule
that manufacturers have continued to
use the nutrient values that were
contained in 21 CFR 105.3(b) (FDA
deleted this paragraph on March 16,
1979 (44 FR 16005)), as label reference
values for use on foods purported or
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2. Application of DVs
Section 403(q) of the act provides
discretion to the agency to require
information about nutrients on the food
label when the agency determines such
information will ‘‘assist consumers in
maintaining healthy dietary practices.’’
Section 2(b)(1)(A) of the 1990
amendments states 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
context of a total daily diet.’’ In the 1993
nutrient content final rule, FDA stated
that ‘‘the nutrition label can and should
help consumers make informed food
choices, and that it can also contribute
to consumers maintaining healthy
dietary practices’’ (58 FR 2079 at 2114).
While the DVs do not represent dietary
goals for individuals, their intended use
is to provide an overall population
reference value on the food label for the
consumer (55 FR 29476 at 29481).
In order to determine a nutrition
labeling format that could be used most
effectively by consumers, FDA
conducted consumer research and
evaluated research conducted by others
in considering requirements for the
nutrition label format in the 1993
nutrient content final rule (58 FR 2079
at 2115–2121). Based on the results of
several consumer studies that evaluated
the ability of nutrition label formats to
enable consumers to understand the
relative significance of product nutrition
information in the context of a total
daily diet, FDA concluded the
following: (1) The declaration of
nutrient amount information as
percentages of DV or the placement of
adjectives (e.g., high, medium, or low)
next to the nutrient amount information
are effective ways to help consumers
understand the significance of product
nutrition information in the context of
the total daily diet; (2) the percent DV
declarations moderate dietary
judgments about a food; and (3) other
format elements, such as a list of DRVs
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for important macronutrients,
highlighting, or grouping nutrients
according to Dietary Guidelines for
Americans, did not help consumers to
make better dietary judgments (58 FR
2079 at 2118). Upon reviewing the
results of several studies that evaluated
the consumer’s use of the nutrition
label, the two most reported uses
identified by FDA were to evaluate
nutrition characteristics of single
products and to assist in making choices
between products (58 FR 2079 at 2121
and references cited therein).
Informed choices include making
judgments about a food product’s
contribution to the total diet and making
comparisons between the nutritional
quality of different food products.
Findings from the FDA Food Label Use
and Nutrition Education Surveys
(FLUNES) conducted in 1994 and 1995
showed that more than half of
consumers used the Nutrition Facts
label to make a judgment about the
overall nutritional quality of a food
product, especially the fat content (Ref.
21).
3. Uses of the DVs in Nutrient Content
and Health Claims
The DVs are used to determine, in
part, whether a food or dietary
supplement is eligible to bear nutrient
content claims or health claims. For
nutrient content claims, a food or
dietary supplement must contain 10 to
19 percent of the DV per Reference
Amount Customarily Consumed (RACC)
in order to be labeled as a good source
of a particular nutrient and must
contain 20 percent or more of the DV
per RACC in order to be labeled as an
excellent source of a particular nutrient
(§ 101.54(b) and (c)). When a health
claim is about the effects at decreased
dietary intake levels (i.e., low claim),
the levels must meet the definition for
use of the term low that has been
established for that substance, unless a
specific alternative level has been
established (§ 101.14(d)(2)(vi)). If no
definition for low has been established,
the level of the substance must meet the
level established in the regulation
authorizing the claim. For health claims,
when a claim is about the effects of
consuming the substance at other than
decreased dietary levels (i.e. not a low
claim), a food must meet the definition
of high (20 percent of the DV) for the
substance that is the subject of the
claim, if the agency has established a
definition for the use of the term ‘‘high’’
for that substance and the agency has
not established an alternative level for
that nutrient in the health claim
regulation (§ 101.14(d)(2)(vii)). For a few
health claims authorized in §§ 101.76,
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101.78, and 101.79, an eligibility
requirement is based upon meeting the
definition for a good source (10 percent)
of the DV for a particular nutrient. The
specific eligibility requirements for each
authorized health claim are set forth in
subpart E, §§ 101.70 to 101.83. In
addition, foods bearing health claims,
other than dietary supplements or
where otherwise provided for in
regulations, must contain 10 percent or
more of the DV, prior to any nutrient
addition, for one of the following
nutrients: Vitamins A, vitamin C, iron,
calcium, protein, or fiber
(§ 101.14(e)(6)).
C. Labeling of Dietary Supplements
As part of the implementation of the
Dietary Supplement Health and
Education Act of 1994, FDA issued final
regulations in the Federal Register of
September 23, 1997 (62 FR 49826),
requiring that a Supplement Facts label
appear on the label or labeling of all
dietary supplements. The Supplement
Facts label is similar to the Nutrition
Facts label in both content and format.
Examples of Supplement Facts labels
can be found in appendix B. The
Supplement Facts label must include
the amount and percent DV of the same
nutrients that are required for
conventional foods if the nutrients are
present in the supplement, as well as
the amount of other dietary ingredients
present (§ 101.36(b)). Nutrients that
have established DVs are listed first,
followed by a horizontal line that
separates these nutrients from dietary
ingredients that have no DVs (e.g.,
botanicals). The Supplement Facts label
must state that percent DVs have not
been established for these dietary
ingredients and must indicate these
ingredients clearly with an asterisk (*)
(§ 101.36(b)(3)(iv)).
D. IOM DRIs and Acceptable
Macronutrient Distribution Ranges
Beginning in 1997, the IOM began
publishing a series of reports on
reference intake values (Refs. 8 to 14),
collectively known as the DRIs. The
DRIs are defined intake levels and
include the AI, estimated average
requirement (EAR), RDA, and the
tolerable upper intake level (UL). DRIs
were set for those vitamins, minerals,
and macronutrients that are essential in
humans and/or provide a beneficial role
in human health. While many of the
RDAs were revised for nutrients that
had an existing RDA (e.g., iron and
vitamin A), some nutrients that had
RDAs now have an AI (e.g., calcium and
vitamin K). Those nutrients that had an
ESADDI, now have either an RDA
(copper and molybdenum) or an AI
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(manganese, fluoride, and chromium).
Although not considered to be a DRI
that provides a defined intake level, the
IOM also set acceptable macronutrient
distribution ranges (AMDRs) for
carbohydrate (i.e., sugars (mono-, diand oligosaccharides) and starch), total
fat, n-3 and n-6 polyunsaturated fatty
acids, and protein (Ref. 13 and Ref. 16
at p. 93). 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.
1. EAR
The EAR for a nutrient is defined as
the daily intake value that is estimated
to meet the requirement for that
nutrient, as defined by a specific
criterion of adequacy or optimal health,
in half of the apparently healthy
individuals in a specific life stage and
gender group. This definition of the
EAR implies a median, rather than a
mean or average. The median and mean
would be the same if the distribution of
requirements followed a symmetrical
distribution.
In the case of energy, the IOM set an
estimated energy requirement (EER) to
represent the average dietary energy
intake that is predicted to maintain
energy balance in a healthy adult of a
defined age, gender, weight, height, and
physical activity level (PAL). PAL is the
ratio of total energy expenditure (TEE)
divided by the basal rate of energy
expenditure. The EER equations use one
of the four PAL categories: Sedentary,
low active, active, and very active. In
children and pregnant and lactating
women, the EER meets the needs
associated with the deposition of tissues
or secretion of milk at rates consistent
with good health.
The EAR and the EER are used for
assessing nutrient intakes of groups. For
nutrients with an EAR and for the EER,
the prevalence of inadequacy in the
population group for the nutrient or
energy level evaluated is usually the
approximate percentage of the
population evaluated whose intakes fall
below the EAR for the nutrient or the
EER (Ref. 22). The EAR for the nutrient
and the EER can also be used to plan for
an acceptably low prevalence of
inadequate intakes within a group. The
EAR for a nutrient and the EER should
not be used as an intake goal for the
individual. Examples of planning for
groups include planning diets in an
assisted-living facility for senior citizens
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or planning menus for a school nutrition
program (Ref. 15).
2. RDAs
The RDA is an estimate of the daily
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
and assuming a normal distribution of
requirements (Ref. 8). An RDA cannot
be set without an EAR. For all nutrients,
except iron, the RDA was set based on
the EAR plus 2–times the standard
deviation (SD) of the EAR : RDA = EAR
+ 2 x SDrequirement. If data about the
variability in the EAR for a nutrient
were insufficient to calculate the SDEAR,
then a coefficient of variation (CV) of 10
percent was assumed.
If individual intakes have been
observed for a large number of days and
are at the RDA, or observed intakes for
fewer days are well above the RDA,
there can be a high level of confidence
that the intake is adequate. Under these
conditions, RDAs can be used for
assessing intakes of individuals for
nutritional adequacy. The RDA can also
be used to plan for intakes of
individuals. The RDA should not be
used to plan intakes of groups. The RDA
is not used to plan intakes of groups
because the median of a target intake
distribution for a group will usually
exceed the RDA because the variance in
usual intakes exceeds the variance in
requirements. Thus, the selection of the
RDA as the median of the target usual
intake distribution for groups is not
recommended as it results in a greater
percentage of inadequacy. The IOM
report on the application of the DRIs in
planning diets for individuals provided
several examples of nutrient-based food
guidance systems that could be used by
individuals for planning diets,
including food and supplement labels
(e.g., the Nutrition Facts label) (Ref. 15).
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3. AI
If there is insufficient scientific
evidence to calculate the EAR and
therefore insufficient evidence on which
to establish an RDA for an essential
nutrient or a nutrient that is beneficial
for human health, then an AI is
determined. AIs are based on the
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following: (1) Scientific evidence for
requirements that is insufficient to set
an EAR (e.g., calcium, vitamin D,
choline, biotin, fluoride, sodium); (2)
experimental data on risk reduction of
chronic disease that are insufficient to
set an EAR (e.g., dietary fiber,
potassium); or (3) median intakes of a
nutrient usually using national nutrition
intake survey data, provided there is no
evidence of a deficiency of the nutrient
in the United States (e.g., pantothenic
acid, vitamin K, chromium, manganese,
linoleic acid, and a-linolenic acid).
There is much less certainty about an AI
value than about an RDA value. The AI
for a nutrient is expected to exceed the
RDA for that nutrient, and therefore it
should cover the needs of more than 97
to 98 percent of individuals. The IOM
set most AIs for young infants (0 to 6
months of age) based on the average
intake of the nutrient consumed
exclusively from breastfed infants,
provided that breast milk provides a
sufficient amount of a nutrient to meet
the needs of the infant. The AIs for older
infants (7 to 12 months) were set based
on: (1) The average intake of the
nutrient consumed exclusively from
breastfed infants and, if data were
available, average intakes of a nutrient
provided by complimentary weaning
foods; and/or (2) extrapolated from the
AI of younger infants; and/or (3)
extrapolated from adult AIs; and/or (4)
clinical data. The AIs for iron and zinc
for older infants could not be set using
intake from breast milk because the
level of iron and zinc in human milk is
not sufficient to meet their needs. For
iron, zinc, and protein; EARs and RDAs
for older infants 7 to 12 months were set
based upon data regarding daily
requirements.
Usual individual intakes that are
equal to or above the AI can be assumed
adequate. The likelihood of inadequacy
of usual intakes below the AI cannot be
determined since there is insufficient
information of the distribution of
requirements. The AI can also be used
to plan for intakes of individuals (Ref.
15).
4. UL
The UL is the highest level of daily
nutrient intake that is likely to pose no
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risk of adverse health effects for almost
all individuals in the specific life stage
group. As intake increases above the UL,
there is a potential for an increased risk
of adverse effects. The UL is not
intended to be a recommended level of
intake, as there is no established benefit
for healthy individuals if they consume
a nutrient in amounts exceeding the
RDA or AI.
The UL can be used to estimate the
percentage of the population at potential
risk of adverse effects from excess
nutrient intake. The UL can also be used
to plan for usual intakes below this level
for an individual or in planning to
minimize the proportion of the
population at risk of excess nutrient
intake (Ref. 15).
5. AMDR
An AMDR is a range of intakes for a
particular energy source (e.g., fat, fatty
acids, carbohydrate, and protein) that is
associated with reduced risk of chronic
disease while providing adequate
intakes of essential nutrients. The
AMDR of a macronutrient (e.g., fat) is
expressed as a percentage of total energy
intake because its requirement is
dependent on other energy sources (e.g.,
carbohydrate and protein). If an
individual consumes below or above
this range, there is a potential for
increasing the risk of chronic diseases
shown to affect long-term health, as well
as increasing the risk of insufficient
intakes of essential nutrients.
6. DRIs Set for Macronutrients and
Micronutrients
Based on the review of all
macronutrients and micronutrients that
are known to be essential and/or
beneficial in humans, the IOM set the
DRIs that are listed for each nutrient in
tables 2 to 10 of this document. As can
be seen from tables 11a and 11b of this
document, the population-coverage and
population-weighted AIs for fluoride
and the population-coverage RDAs for
synthetic niacin exceed the UL for
children 4 to 8 years.
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E. IOM Report on Guiding Principles for
Nutrition Labeling
In 2003 the IOM committee on
nutrition labeling (the IOM Committee)
considered how the DRIs can be used to
develop appropriate reference values for
nutrition labeling (Ref. 16). The IOM
Committee’s report recommended the
following 10 guiding principles for
nutrition labeling:
• Nutrition information in the
Nutrition Facts label should continue to
be expressed as percent DV. The
concept of percent DV was developed
by FDA in response to NLEA to help
consumers better comprehend the
nutritional value of food and to
understand its relative significance in
the context of a daily diet. The percent
DV concept was modeled after the
‘‘percent of U.S. RDAs’’ used in 1973
labeling. The use of the percent DV
concept has been supported by
consumer studies (58 FR 2079). The
IOM Committee concluded that the
rationale to use percent DV was
compelling and suggested no alternative
approach.
• The DVs should be based on a
population-weighted reference value
using census data and proportions of
each life stage and gender group. The
IOM Committee’s rationale for using a
population-weighted approach was that
the DRIs for the various age and gender
groups should be represented by the DV
of the population in the same
proportions. A DV defined this way
would represent a central value of the
requirement of the base population,
with individual requirements varying
around this value.
As discussed previously in this
document, the population-weighted
approach is one of two approaches for
setting one DV for all individuals 4
years of age and older. Currently, FDA
uses the population-coverage approach
for setting a single DV which represents
the highest recommended intake level
among all life stage and gender groups,
excluding pregnant and lactating
women. Although the degree of change
will differ for each nutrient, the DV
would be lower using the populationweighted approach for most nutrients
when compared to a DV derived using
the population-coverage approach (see
tables 11a and 11b of this document).
Note that if the DV for a nutrient is
increased, then a serving of food would
have a lower percent DV on the
Nutrition Facts label.
TABLE 11A. COMPARISON OF THE CURRENT DVS WITH THE EAR, RDA, AND UL USING THE POPULATION-COVERAGE OR
POPULATION-WEIGHTED APPROACH
Nutrient
Unit of Measure
Current DV
Highest RDA
Weighted RDA1
Highest EAR
Weighted EAR1
UL 4 to 8 years2
2.0
0.9
0.8
0.7
0.7
3
Nutrients Assigned an EAR and RDA
Copper
mg
Folate
µg
400
400
378
330
304
400
Iodine
µg
150
150
144
95
91
300
Iron
mg
18
18
11
8
6
40
Magnesium
mg
400
420
341
350
283
110
Molybdenum
µg
75
45
42
34
32
600
Niacin
mg
20
16
14
12
11
15
Phosphorus
mg
1,000
1,250
769
1,055
640
3,000
g
50
56
47
46
39
-
Protein
Riboflavin
mg
Selenium
µg
Thiamin
mg
Vitamin A
1.7
1.3
70
1.1
55
1.5
52
1.2
1.1
1.1
0.9
45
43
1.0
0.9
—
150
—
IU
5,000
3,000
2,511
2,100
1,768
—
µg
1,500 RE
900 RAE
754 RAE
630 RAE
531 RAE
900
mg
2.0
1.7
1.3
1.4
1.1
40
Vitamin B12
µg
6.0
2.4
2.3
2.0
1.9
—
Vitamin C
mg
60
90
74
75
61
650
Vitamin E
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Vitamin B6
IU
30 IU
—
—
—
—
—
15
14
12
11
300
mg atocopherol
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TABLE 11A. COMPARISON OF THE CURRENT DVS WITH THE EAR, RDA, AND UL USING THE POPULATION-COVERAGE OR
POPULATION-WEIGHTED APPROACH—Continued
Nutrient
Unit of Measure
Zinc
Current DV
mg
Weighted RDA1
15
Highest EAR
Weighted EAR1
UL 4 to 8 years2
9.1
Highest RDA
9.4
7.7
12
11
1Population-weighted means of life-stage and gender specific RDAs, EARs, AIs, and ULs were computed for adults and children 4 or more
years of age, using 2005 Middle Series Data from Annual Projections of the Resident Population by Age, Sex, Race, and Hispanic Origin: Lowest, Middle, Highest, and Zero International Migration Series, 1999 to 2100 (NP-D1-A), (https://www.census.gov/population/www/projections/
natdet-D1A.htm), U.S. Census Bureau, Population Projection Program , accessed July 19, 2006. Life-stage and gender specific RDAs, EARs,
AIs, and ULs were multiplied by the population projection for the corresponding life-stage and gender group (e.g., children 4 to 8 years old,
males 9 to 13 years old). Sum of these values were divided by the total population projection for adults and children 4 or more years of age.
2The ULs for vitamin E, niacin, and folate apply to synthetic forms obtained from supplements, fortified foods, or a combination of the two. The
ULs for vitamin A apply only to preformed vitamin A. The ULs for magnesium represent intake from a pharmacological agent only and do not include intake from food and water.
RE=retinol equivalents, RAE=retinol activity equivalents
TABLE 11B. COMPARISON OF THE CURRENT DVS WITH THE AIS AND ULS USING THE POPULATION-COVERAGE OR
POPULATION-WEIGHTED APPROACH
Nutrient
Unit Of Measure
Current DV
Highest AI
Weighted AI1
Highest UL
Weighted UL1
UL 4 to 8 years
Nutrients Assigned an AI
Biotin
µg
300
30
28
—
—
—
Calcium
mg
1,000
1,300
1,091
—
—
2,500
Chloride
mg
3,400
2,300
2,150
3,600
3,536
2,900
Choline
mg
5502
550
460
—
—
1,000
Chromium
µg
120
35
27
—
—
—
293
—
—
—
13
—
—
—
Fiber
g
25
383
Linoleic acid
g
—
17
a-Linolenic acid
g
—
1.6
1.3
—
—
—
Manganese
mg
2.0
2.3
1.9
—
—
3
Pantothenic acid
mg
10
5
5
—
—
—
Potassium
mg
3,500
4,700
4,622
—
—
—
mg
2,4004
1,500
1,410
2,300
2,265
1,900
IU
400
600
280
—
—
—
µg
10
15
7
Vitamin K
µg
80
120
95
—
—
Fluoride
mg
—
4
3
—
—
Sodium
Vitamin D
50
—
2.2
1Population-weighted
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means of life-stage and gender specific RDAs, EARs, AIs, and ULs were computed for adults and children 4 or more
years of age, using 2005 Middle Series Data from Annual Projections of the Resident Population by Age, Sex, Race, and Hispanic Origin: Lowest, Middle, Highest, and Zero International Migration Series, 1999 to 2100 (NP-D1-A), (https://www.census.gov/population/www/projections/
natdet-D1A.htm), U.S. Census Bureau, Population Projection Program , accessed July 19, 2006. Life-stage and gender specific RDAs, EARs,
AIs, and ULs were multiplied by the population projection for the corresponding life-stage and gender group (e.g., children 4 to 8 years old,
males 9 to 13 years old). Sum of these values were divided by the total population projection for adults and children 4 or more years of age.
2A notification was submitted under section 403(r)(2)(G) of the act (21 U.S.C. 343(r)(2)(G)) in 2001 for the use of certain nutrient content
claims for choline. These statements identify the daily value for choline as 550 mg (see footnote 5 of this document). This value is based on the
AI set by the IOM of the NAS in 1998 (Refs. 9 and 20).
3Based on AI of 14g/1,000 calories.
4Daily reference value to not be exceeded.
• A population-weighted EAR should
be the basis for DVs for those nutrients
for which EARs have been identified.
The Committee’s rationale for using an
EAR, rather than the RDA, to set the DV
was the Committee’s belief that the EAR
represents the most accurate
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representation of the true contribution
of food to total nutrient needs in the
general population.
Currently, the RDIs are based on
RDAs, when available. There are 16
nutrients for which the DV is currently
based on an RDA and now have a new
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EAR and RDA.6 Because the RDA is 2
standard deviations greater than the
6Currently there are DVs that were based on RDAs
for vitamin A, vitamin C, iron, vitamin E, thiamin,
riboflavin, niacin, vitamin B6, folate, vitamin B12,
phosphorous, iodine, magnesium, zinc, selenium,
and protein.
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EAR, a DV based on an EAR would be
lower than when based on the RDA (see
table 11a of this document). The
population-weighted EAR yields the
lowest values compared to populationcoverage RDA, population-weighted
RDA, or population-coverage EAR (see
table 11a of this document). The
population-weighted EAR can vary from
as little as 21 percent lower than the
population-coverage RDA for vitamin
B12, to 41 percent lower for vitamin A,
to as much as 67 percent lower for iron.
• If no EAR has been set for a
nutrient, then a population-weighted AI
should be used as the basis for a DV.
An AI is a proxy for an RDA,
however, the AI is not the equivalent of
an EAR. Thus, when an AI is set for a
nutrient, there is no other recommended
intake level that is set for that nutrient.
AIs were determined for 15 nutrients
(tables 2 and 3 of this document). As
can be seen in table 11b of this
document, a reference value for labeling
based on a population-weighted AI is
lower for most nutrients than a
reference value that is derived based on
the population-coverage approach that
uses the highest AI. As discussed
previously in this document, AIs for
children and adults were based on
experimental data that were not
sufficient for setting an EAR or were
based on median intake levels. The IOM
labeling report did not address the issue
of whether AIs based on either approach
should or should not be considered in
setting a DV. The IOM labeling report
did not address the AIs set for sodium
and potassium because the IOM DRI
report on electrolytes and water was not
completed (Ref. 14).
• The AMDR should be the basis for
the DVs for protein, total carbohydrate,
and total fat. The IOM labeling
committee recommended that using the
AMDRs to set reference values for
protein, total carbohydrate, and total fat
is appropriate to promote healthful
dietary practices and nutritionally
adequate diets and would provide
consistency. Because the IOM set
AMDRs (percent of energy) for all three
macronutrients, the IOM Committee
recommended setting the DV based on
the following: (1) The midpoint of the
AMDR for carbohydrate (starch and
sugars), (2) a population-weighted
midpoint of the AMDR for total fat since
AMDRs varied for age, and (3) the
difference (100 percent of energy - (DVfat
+ DVcarbohydrate)) for protein. The IOM
Committee stated that using the
midpoint of the AMDR values avoids
extreme values from the upper or lower
boundaries and is an approach that
focuses on moderation. The IOM Panel
on Macronutrients did not set a UL for
total or added sugars, but identified a
suggested maximum intake level of no
more than 25 percent of energy from
added sugars. However, the IOM
Committee recommended against using
this value for nutrition labeling because
it could be misrepresented as a desirable
intake level. Although the IOM panel on
macronutrients set an AMDR for
protein, they also set EARs and RDAs
for protein (see tables 11a and 12 of this
document).
Currently, the DV for protein is based
on 10 percent of 2,000 calories using an
adjusted average of the 1989 RDA (Ref.
3). Although protein has a DV, the
declaration of a percent DV for protein
on the label is optional unless a claim
is being made. The declaration of a
percent DV for protein is optional due,
in part, to the cost consideration of
determining the protein digestibilitycorrected amino acid score which is
necessary to calculate the percent DV of
protein (58 FR 2079 at 2102).
TABLE 12.—COMPARISON OF THE CURRENT DVS IN GRAMS TO THE LOWER, MIDPOINT, AND UPPER ACCEPTABLE
MACRONUTRIENT DISTRIBUTION RANGES FOR A 2,000 CALORIE DIET
Current DV
Nutrient
Percent of Energy
AMDR
Percent of energy
Grams (for 2,000
calories per day)
AMDR
Grams (for 2,000 calories per day)1
Low
Midpoint
High
Low
Midpoint
High
Adults
Protein
10
50
10
22.5
35
50
Fat
Linoleic acid
a-Linolenic
302
—
—
65
—
—
20
5
0.6
27.5
7.5
0.9
35
10
1.2
44.4
11
1.3
Carbohydrate
60
3003
45
55.0
65
Protein by difference
2254
17.5
Total energy
100
112.5
61.1
17
2
2754
175
77.7
22
2.7
3254
87.5
100
Children Age 4 to 18 Years
10
50
10
20
30
50
Fat
Linoleic acid
a-Linolenic
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Protein
302
—
—
65
—
—
25
5
0.6
30
7.5
0.9
35
10
1.2
55.6
11
1.3
Carbohydrate
60
3003
45
55
65
Protein by difference
15
Total energy
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75
100
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TABLE 12.—COMPARISON OF THE CURRENT DVS IN GRAMS TO THE LOWER, MIDPOINT, AND UPPER ACCEPTABLE
MACRONUTRIENT DISTRIBUTION RANGES FOR A 2,000 CALORIE DIET—Continued
Current DV
Nutrient
Percent of Energy
AMDR
Percent of energy
Grams (for 2,000
calories per day)
AMDR
Grams (for 2,000 calories per day)1
Low
Midpoint
High
Low
Midpoint
High
Age 4 Years and Older (Weighted per IOM Labeling Report, Table B–4)
Fat5
Linoleic acid
a-Linolenic
302
—
—
65
—
—
Carbohydrate6
60
3003
28
7.5
0.9
35
10
1.2
45
55
65
2254
2754
3254
34
Protein by difference7
21
5
0.6
17
0
170
85
0
Total energy
46.7
11
1.3
62
17
2
77.7
22
2.7
100
1Derived
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by converting percent energy to g/d using Atwater factors 4 calories/g for carbohydrates and protein and 9 calories/d for fat for a
2,000 calories diet.
2Based on a Dietary Guideline recommendation of no more than 30 percent of energy from fat.
3Carbohydrate represents sugars, starch, fiber, and organic acids.
4Carbohydrate represents starch and sugars.
5The AMDR for total fat is comprised of population-weighted values computed based on U.S. Census Bureau estimates of the U.S. population
in 2005.
6No weighting was done for this group.
7Calculated using the difference (100 percent of energy - (DV
fat + DVcarbohydrate)) for protein.
For the purpose for food labeling,
total carbohydrate in food is currently
calculated by subtraction of the sum of
crude protein, total fat, moisture, and
ash from the total weight of the food and
includes starch, sugars, sugar alcohols,
and fiber (§ 101.9(c)(6)). The current DV
for total carbohydrate is based on the
100 percent of energy minus the sum of
the DV for fat (30 percent) plus the DV
for protein (10 percent). Thus, the DV is
60 percent of a 2,000 calorie diet (300
g) for total carbohydrate. In contrast to
the calculation of total carbohydrates
(§ 101.9(c)(6)), the IOM panel on
macronutrients set an AMDR for
carbohydrates and also set an EAR and
RDA for carbohydrate that specifically
represents starch and sugars, but does
not include sugar alcohols or fiber (see
tables 8, 10, and 12 of this document).
Therefore, the recommendation by the
IOM Committee to use the AMDR for
setting a DV for total carbohydrate
would limit the definition and
corresponding DV to sugars and starch.
The current DV for fat (65 g) is based
on the NAS Diet and Health Report (Ref.
4) which recommended no more than 30
percent of energy from fat and
represents triglyceride content
(§ 101.9(c)(2)). The IOM panel on
macronutrients set AMDRs for total fat
and fatty acids linoleic and a-linolenic
acid (see table 12 of this document). The
IOM panel on macronutrients also set
AIs for linoleic and a-linolenic acid (see
table 11b of this document).
Table 12 of this document shows the
current DV, the lowest, the midpoint,
and the highest value for each AMDR
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set by the IOM DRI panel on
macronutrients, and the AMDRs
adjusted using the population-weighted
approach. As can be seen in table 12 of
this document for fat, linoleic acid, alinolenic acid, and carbohydrate, the
lowest, the midpoint, and the highest
AMDR values are similar to the values
obtained using the population-weighted
AMDRs. The approach that was
recommended by the IOM Committee,
i.e., using the midpoint of the AMDR for
fat and carbohydrate as the basis for
label reference values, would yield
values of 62 g/d of fat, 85 g/d protein,
and 275 g/d carbohydrate.
• Two thousand calories should be
used, when needed, as the basis for
expressing energy intake when
developing DVs. Although EERs were
set for all life-stage groups (Ref. 13), the
IOM Committee recognized that the
EERs are dependent upon height,
weight, and physical activity level. In
addition, the EER equations are based
on normal weight individuals, and the
United States has a high prevalence of
obese and overweight individuals (64
percent of adults and 15 percent of
children) (Ref. 16). The IOM Committee
found that the data necessary to use the
EER to derive a calorie reference value
is incomplete. Therefore, the IOM
Committee recommended retaining the
current 2,000 calorie reference level
(Ref. 16).
• The DVs for saturated fatty acids,
trans fatty acids, and cholesterol should
be set at a level that is as low as possible
in keeping with an achievable healthpromoting diet. The rationale for this
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recommendation is based on the DRI
macronutrient report (Ref. 13) which
did not set ULs but recommended that
saturated fatty acid, trans fatty acid and
cholesterol intakes should be as low as
possible while consuming a
nutritionally adequate diet. The current
DV for saturated fat (not more than 10
percent of energy (20 g/d) and
cholesterol (300 mg/d)) is based on the
NAS Diet and Health Report (Ref. 4).
For FDA to establish a DV for trans
fatty acids, saturated fat, and
cholesterol, the IOM Committee
suggested that FDA use food
composition data, menu modeling, and
data from dietary surveys to estimate
minimum intakes consistent with
nutritionally adequate and healthpromoting diets for diverse populations.
In April of 2004, FDA held a meeting of
the Nutrition Subcommittee of the Food
Advisory Committee on total fat and
trans fat (the subcommittee) (Ref. 23).
The subcommittee concluded that
currently there is not enough scientific
evidence to recommend a specific
acceptable daily intake for trans fatty
acids.
• While the general population is best
identified as all individuals 4 years of
age and older, four distinctive life stages
were identified for developing separate
DVs: Infants (< 1 year), toddlers (1 to 3
years), pregnancy, and lactation.
Because infants, toddlers, and pregnant
women and lactating women have
specific nutritional needs, the IOM
Committee stated that a single DV for
the entire population could over- or
underestimate the nutrient contribution
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of foods for these four groups.
Therefore, the IOM Committee
recommended that separate DVs for
foods manufactured specifically for
these four groups be used for that
specific life-stage group.
See discussion in section I.B.1 of this
document on requirements for foods
that are represented or purported to be
for the use of infants (up to 12 months
of age) or children 1 to 4 years of age,
and pregnant women or lactating
women.
• The Supplement Facts label should
use the same DVs as the Nutrition Facts
label. The IOM Committee
recommended that all other guiding
principles should apply to dietary
supplement labeling. The IOM
Committee came up with this
recommendation because the
Supplement Facts label requires the
inclusion of the percent DVs for the
nutrients that are mandated for
conventional food (21 U.S.C. 321(ff)).
Therefore, the comparisons that are
shown for the Nutrition Facts label in
tables 11a and 11b of this document are
the same for the Supplement Facts label.
• Absolute amounts should be
included in the Nutrition Facts and
Supplement Facts labels for all
nutrients. The IOM Committee
concluded that including absolute
amounts (e.g., mg/serving) would assist
consumers who want nutrient
information but are yet unable to
understand the percent DVs.
Furthermore, absolute amounts for
macronutrients are already required on
the Nutrition and Supplement Facts
labels. Therefore, the IOM Committee
stated that adding absolute amounts for
micronutrients would make the labeling
consistent. The IOM Committee also
recommended that the units used for
vitamin A (IU), vitamin D (IU), vitamin
E (IU), folate (µg), copper (mg), sodium
(mg), potassium (mg) and chloride (mg)
be changed to be consistent with the
units in the new DRI reports (vitamin A
(µg Retinol Activity Equivalents),
vitamin D (µg), vitamin E (mg atocopherol), folate (µg dietary folate
equivalents), copper (µg), sodium (g),
potassium (g), and chloride (g)).
F. IOM Report on the Definition of Fiber
1. Definitions
Because there is not a formal
definition for dietary fiber, dietary fiber
is the material isolated using AOAC
INTERNATIONAL EnzymaticGravimetric Method 985.29 (Ref. 12).
This method includes lignin and
nonstarch polysaccharides and some
resistant starch, inulin, chitin, chitosan,
chondroitin sulfate, and
noncarbohydrate material. This method
does not include oligosaccharides,
polydextrose, or resistant maltodextrins.
Currently, dietary fiber is indented
under ‘‘Total Carbohydrates’’ in the
Nutrition Facts label (§ 101.9(c)(6)(i)).
In 2001 the IOM Panel on the
Definition of Dietary Fiber (the IOM
Panel) responded to FDA’s request to
provide definitions for dietary fiber
based on its role in human physiology
and health. The IOM Panel developed
two categories of definitions of fiber:
‘‘Dietary Fiber’’ and ‘‘Functional Fiber’’
(Ref. 12). See table 13 of this document
from the IOM Report on the Definition
of Dietary Fiber, which lists the
characteristics of dietary fiber currently
determined by FDA and by the IOM
definitions for dietary and functional
fibers.
TABLE 13.—CHARACTERISTICS OF VARIOUS DIETARY FIBER DEFINITIONS1
Reference
U.S. Food and Drug
Administration
(USFDA), 19874
Nondigestible
Animal
CHOs2
CHOs Not
Recovered by
Alcohol
Precipitation3
Yes
Some inulin
Nondigestible
Mono- and
Disaccharides
Lignin
Resistant
Starch
Intact, Naturally
Occurring Food
Sources Only
Resistant
to Human
Enzymes
Specifies
Physiological
Effect
No
Yes
Some
No
No
No
Institute of Medicine (IOM) (Proposed), 2001
Dietary Fiber
No
Yes
No
Yes
Some
Yes
Yes
No
Added Fiber
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
1All
definitions are assumed to include nonstarch polysaccharides.
= carbohydrate.
inulin, oligosaccharides (3–10 degrees of polymerization), fructans, polydextrose, methylcellulose, resistant maltodextrins, and other
related compounds.
4Method-based definition.
Source: Adapted from the IOM, ‘‘Dietary Reference Intakes: Proposed Definition of Dietary Fiber,’’ Washington, DC: National Academy Press,
2001.
2CHO
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3Includes
a. The IOM Panel defined ‘‘Dietary
Fiber’’ as nondigestible carbohydrates
and lignin that are intrinsic and intact
in plants. Nondigestible means that the
material is not digested and absorbed in
the human small intestine. Fractions of
plant foods are still considered ‘‘Dietary
Fiber’’ if the plants’ cells and their three
dimensional interrelationships remain
largely intact. Examples of ‘‘Dietary
Fiber’’ include cereal brans; resistant
starch that is naturally occurring;
naturally occurring oligosaccharides
such as raffinose, stachyose, verbacose;
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and low molecular weight fructans. The
known physiological benefits of foods
containing ‘‘Dietary Fiber,’’ such as
attenuation of postprandial blood
glucose and cholesterol levels and
improved laxation, are recognized.
b. The IOM Panel defined ‘‘Functional
Fiber’’ as isolated, nondigestible
carbohydrates that have beneficial
physiological effects in humans.
‘‘Functional Fibers’’ can be isolated or
extracted nondigestible carbohydrates,
using chemical, enzymatic, or aqueous
procedures or synthetically
manufactured. Provided that one or
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more beneficial physiological effects are
demonstrated in humans, examples of
‘‘Functional Fiber’’ would include
isolated nondigestible animal
carbohydrates, pectins or gums,
resistant starch formed during
processing, and synthetic fibers such as
resistant maltodextrin and
fructooligosaccharides. At this time,
current FDA regulations have not
established formal criteria for
establishing the beneficial physiological
effects of potential ‘‘Functional Fibers.’’
c. The IOM Panel defined ‘‘Total
Fiber’’ as the sum of ‘‘Dietary Fiber’’
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and ‘‘Functional Fiber.’’ Thus, while
there is currently one category of dietary
fiber in the Nutrition Fact label, the
Panel has provided three definitions of
fiber for potential use. The AI set by the
IOM is for ‘‘Total Fiber.’’
2. Soluble and Insoluble Fiber
The IOM Panel recommended that the
terms soluble and insoluble fiber be
phased out and replaced with an
appropriate physicochemical property
(e.g., viscous or fermentable fiber) of the
specific fiber as these become
standardized. This recommendation is
based on scientific findings that suggest
that the physiological benefit of a fiber
(e.g., attenuation of blood glucose and
cholesterol concentration and improved
laxation) is not related to the solubility
of a fiber. There is evidence indicating
that viscous fibers and fibers that are
slowly, incompletely, or not fermented
can provide beneficial physiological
effects. The IOM Panel recommended
that viscosity or fermentability of a fiber
be considered as characteristics to
distinguish ‘‘Dietary Fibers’’ and
‘‘Functional Fibers’’ that modulate
gastric and small bowel function from
those that provide substantial stool bulk
which is affected by fiber solubility and
may or may not affect gastric and small
bowel function.
Currently, a statement of the number
of grams of soluble (§ 101.9(c)(6)(i)(A))
and insoluble (§ 101.9(c)(6)(i)(B)) dietary
fiber can be voluntarily declared and
indented under dietary fiber and both
are identified and quantified using
AOAC INTERNATIONAL methods.
ebenthall on PROD1PC69 with PROPOSALS
3. Analytical Issues
The IOM Panel recognized that
adoption of the two definitions for fiber
would challenge the currently available
analytical methods, requiring changes to
the current analytical methods.
Particularly, separating out ‘‘Dietary’’
and ‘‘Functional Fibers,’’ of which there
could be a potential overlap (e.g.,
resistant starch and dietary fibers that
are extracted, concentrated, and added
to foods (gums, cellulose, pectin)). The
IOM Panel proposed modifications to
the current methods. While further
refinement of these methods is made,
the IOM Panel indicated that it would
be more practical to determine ‘‘Total
Fiber’’ using the current methods.
G. Current Regulations on Trans Fat
In the Federal Register of July 11,
2003 (68 FR 41434), FDA amended its
regulations on nutrition labeling to
require trans fatty acids be declared in
grams per serving in the nutrition label
of conventional foods and dietary
supplements (the 2003 trans fat final
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rule). No DV was established for trans
fatty acids. Required labeling became
effective on January 1, 2006.
In the Federal Register of July 11,
2003 (68 FR 41507), FDA published an
ANPRM (the 2003 trans fat 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 current 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. FDA also requested comments
on whether it 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), FDA
reopened the comment period for the
2003 trans fat ANPRM to receive
comments that considered the
information in the 2003 IOM report on
nutrition labeling (Ref. 16) that
addressed the labeling of trans fat (see
section II.E of this ANPRM). In addition
to the questions raised in the 2003 trans
fat ANPRM, FDA sought comments on
the 2003 IOM labeling report’s approach
to establish a DV using food
composition data, menu modeling, and
dietary survey data to estimate a
minimum trans fat intake within a
nutritionally adequate diet. FDA also
sought comment on whether the IOM
approach of using food composition
data, menu modeling, and dietary
survey data should be used to revise the
DV for saturated fat. Public comments
were also sought on the IOM
recommendation to list saturated fat and
trans fat on separate lines of the
Nutrition Facts label, but have one
numerical value for the percent DV for
these two nutrients together. In
addition, if FDA were to use one
numerical value for the percent DV for
both trans fat and saturated fat together,
the agency asked for comment about
whether such value should be
determined by adding a new DV
established for saturated fat to the DV
for trans fat, or, alternatively, whether
the agency should establish a joint DV
for saturated and trans fats that would
then be used to calculate one numerical
value as the percent DV for both fats.
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62167
On April 19, 2004 (69 FR 20838), FDA
extended the comment period for the
2003 trans fat ANPRM to receive
comments that considered the
information in the 2004 subcommittee
meeting (Ref. 23) that addressed
whether the available scientific
evidence supports 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.
Because of their relevance to the
Nutrition Facts label, FDA intends to
consider, as comments to this ANRPM,
the comments to the 2003 trans fat
ANPRM on the IOM approach for
calculating a DV for saturated fat and
trans fat and listing of saturated and
trans fats on separate lines of the
Nutrition Facts label with one
numerical value for the percent DV for
both, and how to calculate the percent
DV as one numerical value. Comments
to the 2003 trans fat ANPRM on the
outcome of the subcommittee meeting
will also be considered. Public
comments on these issues are being
asked again in this ANPRM so that these
issues can be considered in the context
of the entire Nutrition Facts and
Supplement Facts labels along with
other questions being asked in this
ANPRM.
H. ANPRM on Prominence of Calories
In the Federal Register of April 4,
2005 (70 FR 17008), FDA 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 (OWG) 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.
FDA also sought comment of 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, FDA also requested comments
on questions posed concerning the
declaration of ‘‘calories from fat’’ (70 FR
17008 at 17010). Because of their
relevance to the Nutrition Facts label,
FDA intends to consider, as comments
to this ANRPM, comments to the 2005
prominence of calories ANPRM related
to questions posed on a percent DV for
total calories and calories from fat.
Public comments on the specific
question about establishing a percent
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DV for total calories and the questions
posed concerning ‘‘calories from fat’’ are
being requested in this ANPRM so that
these questions can be considered in the
context of the entire Nutrition Facts and
Supplement Facts labels along with
other questions being asked in this
ANPRM.
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I. Carbohydrate Content of Food
FDA received nine citizen petitions
that requested, among other things, that
the agency amend our nutrition labeling
requirements related to the declaration
of total carbohydrate content of foods.7
With respect to carbohydrate labeling,
the agency is requesting comment in
this ANPRM on questions related to the
label declaration of carbohydrate in the
Nutrition Facts and Supplement Facts
labels (see section II.C.10 of this
document).
J. ‘‘2005 Dietary Guidelines for
Americans’’
The ‘‘2005 Dietary Guidelines for
Americans’’ (the 2005 Dietary
Guidelines) developed jointly by the
U.S. Department of Health and Human
Services and the U.S. Department of
Agriculture provide several key
numerical recommendations with
respect to micronutrients and
macronutrients, of which most are based
on the DRI reports (Ref. 7). These
recommendations are as follows:
• Consume less than 10 percent of
calories from saturated fat and less than
300 mg/d of cholesterol. These
recommendations are the same as the
current DRVs for saturated fat and
cholesterol.
• Keep total fat intake between 20
and 35 percent of calories, the AMDR
for total fat.
• Consume less than 2,300 mg/d of
sodium, the UL for sodium.
The 2005 Dietary Guidelines also
identified nutrients of concern based on
dietary intake data or evidence of public
health problems. The nutrients of
concern are identified for:
• Adults: Calcium, potassium, fiber,
magnesium, and vitamins A (as
carotenoids), C, and E;
• Children and adolescents: Calcium,
potassium, fiber, magnesium, and
vitamin E.
The 2005 Dietary Guidelines also
identified nutrients of concern for
specific populations groups. Vitamin
B12 was identified as a nutrient of
concern for people over the age of 50.
Iron was identified as a nutrient of
7The nine citizen petitions can be found in
Docket Nos. 2004P–0105/CP1, 2004P–0107/CP1,
2004P–0110/CP1, 2004P–0297/CP1, 2004P–0298/
CP1, 2004P–0299/CP1, 2004P–0293/CP1, 2004P–
0473/CP1, 2004P–0542/CP1.
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concern for women of childbearing age
who may become pregnant. Folic acid
was also identified as a nutrient of
concern for women of childbearing age
who may become pregnant and those in
the first trimester of pregnancy. Vitamin
D was identified as a nutrient of concern
for older adults, people with dark skin,
and people exposed to insufficient
ultraviolet band radiation (i.e.,
sunlight).
II. Agency Request for Information
FDA has not updated or set new DVs
since 1995. In 2003, the IOM completed
its first review of nutrients using the
DRI process. This review has generated
discussion in the scientific community.
FDA plans to revise the reference values
used for the Nutrition Facts and
Supplement Facts labels. FDA requests
comments on the following questions.
As part of the comments, FDA requests
that scientific justification be submitted
in support of the response. FDA
recognizes that an individual
commenter may choose to respond to all
of the questions or only a subset, based
on his/her area of expertise.
A. Approach to Setting DVs
As discussed in section I.D of this
document, beginning in 1997, the IOM
began publishing a series of reports on
reference intake levels, collectively
known as the DRIs. The DRIs provided
revised RDAs and three new reference
intakes for nutrients (AI, EAR, and UL).
The IOM also reported on AMDRs for
macronutrients. FDA requests
comments on the following questions on
which DRIs and AMDRs should be used
for setting DVs.
• Should the DV be based on an EAR
for those nutrients for which an EAR
has been set? Explain why or why not.
• If EARs are used to set DVs, should
they be set based on populationcoverage or population-weighted EAR?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
Explain why or why not.
• Should the DV be set based on an
RDA for those nutrients for which an
RDA has been set? Explain why you
have chosen a particular approach and
why it is preferable to the other
approach.
• If RDAs are used to set DVs, should
they be set based on populationcoverage or population-weighted RDA?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
• Should any or all AIs, regardless of
how they are derived, be used to set
DVs? Explain why or why not. Or,
should only those AIs based on
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experimental data be used to set DVs
(i.e., from intervention studies that are
designed to evaluate nutrient
requirements rather than dietary intake
data from national surveys)? Explain
why or why not.
• If AIs are used to set DVs, should
they be set based on populationcoverage or population-weighted AI?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
B. Populations for Which the DVs are
Intended
Currently the DVs are for persons 4
years of age and older. FDA requests
comments on the following questions on
the populations for which the DVs
should be intended.
• Should the DVs continue to be used
for persons 4 years of age and older?
Explain why or why not.
• Should DVs for different life stage
groups be developed for labeling of food
products specific to these groups, as
recommended in the IOM labeling
report (i.e., separate DVs: Infants (< 1
year), toddlers (1 to 3 years), pregnancy,
and lactation)? Explain why or why not.
If so,
• Should DVs for infants (< 1 year) be
set based on the EARs, RDAs, or AIs for
older infants (7 to 12 months)? Explain
why you have chosen a particular
approach and why it is preferable to the
other approaches.
• Should DVs for toddlers (1 to 3
years) be set based on the EARs, RDAs,
or AIs for toddlers (1 to 3 years)?
Explain why you have chosen a
particular approach and why it is
preferable to the other approaches.
• Should DVs for pregnant women be
set based on the population-weighted or
population-coverage EARs, RDAs, or AIs
for all DRI pregnancy groups (i.e. 14 to
18 years, 19 to 30 years, 31 to 50 years)?
Explain why you have chosen a
particular approach and why it is
preferable to the other approaches.
• Should DVs for lactating women be
set based on the population-weighted or
population-coverage EARs, RDAs, or AIs
for all DRI lactation groups (i.e. 14 to 18
years, 19 to 30 years, 31 to 50 years)?
Explain why you have chosen a
particular approach and why it is
preferable to the other approaches.
C. Labeling of Individual Nutrients
FDA requests comments on the
following questions on individual
nutrients:
1. Calories
• Should 2,000 calories continue to
be used to express reference energy
intake, as recommended in the IOM
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labeling report? Explain why or why
not.
• Should 2,500 calories also be kept
on the label footnote? Explain why or
why not.
• Should the EER (Estimated Energy
Requirements) be used to express
reference energy intake? Explain why or
why not.
• If a population-weighted EER or a
population-coverage EER should be
used, which PAL (sedentary, low active,
active, very active) should be used to
calculate the EER? Explain why you
have chosen a particular approach and
why it is preferable to the other
approaches.
• Would providing for a percent DV
disclosure for total calories assist
consumers in understanding the caloric
content of the packaged food in the
context of a 2,000 calorie diet? Explain
why or why not.
2. Calories From Fat
• What data are there on how
consumers use the listing of ‘‘Calories
from fat?’’
• How does the listing ‘‘Calories from
fat’’ adjacent to ‘‘Calories’’ affect
consumers’ focus on the total calories of
a food?
• What are the advantages or
disadvantages of eliminating the listing
for ‘‘Calories from fat’’ from the
nutrition label?
• What data would be needed to
determine whether the listing of
‘‘Calories from fat’’ is or is not necessary
to assist consumers in maintaining
healthy dietary practices?
3. Calories From Saturated Fat
• Should calories from saturated fat
continue to be voluntary or should it be
made mandatory on the food label?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
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4. Total Fat
• Should a population-weighted
midpoint of the AMDR (e.g. 28 percent
for adults) be used, as suggested in the
IOM labeling report? Explain why or
why not.
Note: 28 percent of 2,000 calories/d is
560 calories/d. 560 calories/d divided
by 9 calories/g is 62 g/d.
• Should the upper range of AMDR of
35 percent be used? Explain why or why
not.
Note: This would increase the DRV from
65g/d to 78 g/d for 2,000 calorie diet. 35
percent of 2,000 calories is 700 calories.
700 calories divided by 9 calories/g is ~
78g.
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5. Saturated Fat
• Should the current DRV of 20g/d
from saturated fat remain, as
recommended by the 2005 Dietary
Guidelines? Explain why or why not.
• Should food composition data,
menu modeling, and data from dietary
surveys be used to establish a DRV for
saturated fat that is as low as possible
while consuming a nutritionally
adequate diet, as recommended in the
IOM labeling report? Explain why or
why not.
6. Trans Fat
• Should food composition data,
menu modeling, and data from dietary
surveys be used to establish a DRV for
trans fat that is as low as possible while
consuming a nutritionally adequate diet,
as recommended in the IOM labeling
report? Explain why or why not.
• Should saturated fat and trans fat
be listed on separate lines of the
Nutrition Facts label, but have one
numerical value for the percent daily
value for these two nutrients together, as
recommended in the IOM labeling
report? Explain why or why not.
• If one numerical value is used for
the percent DV for both trans fat and
saturated fat together, should such value
be determined by adding the DV for
saturated fat to the DV for trans fat, or,
alternatively, should the agency directly
establish a joint DV for saturated and
trans fats that would then be used to
calculate one numerical value as the
percent DV for both fats?
7. Polyunsaturated Fat
• Should polyunsaturated fat
continue to be voluntary or should it be
made mandatory on the food label?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
• Should a DRV for polyunsaturated
fat (n-3 plus n-6) be established using
the AMDRs for n-6 (5–10 percent) and
n-3 (0.6–1.2 percent) of total calories? If
so, should the midpoint be used?
Explain why or why not.
Note: 7.5 percent (midpoint) for n-6 and
0.9 percent (midpoint) for n-3 of 2,000
calories =19g/d polyunsaturated fat.
• Should a DRV for polyunsaturated
fat be derived based upon AIs for
linoleic acid (n-6 polyunsaturated fat)
plus a-linolenic acid (n-3
polyunsaturated fat)? Explain why or
why not.
• Should separate DRVs for linoleic
acid (n-6 polyunsaturated fat) and alinolenic acid (n-3 polyunsaturated fat)
be established? Explain why or why not.
• If separate DRVs for linoleic acid (n6 polyunsaturated fat) and a-linolenic
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acid (n-3 polyunsaturated fat) are
established should they be voluntary or
should they be made mandatory on the
food label? Explain why you have
chosen a particular approach and why
it is preferable to the other approach.
8. Monounsaturated Fat
• Should monounsaturated fat
continue to be voluntary or should it be
made mandatory on the food label?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
9. Cholesterol
• Should the current cholesterol DRV
of 300 mg/d remain, as recommended
by the ‘‘2005 Dietary Guidelines for
Americans’’? Explain why or why not.
• Should food composition data,
menu modeling, and data from dietary
surveys be used to establish a DRV for
cholesterol that is as low as possible
while consuming a nutritionally
adequate diet, as recommended in the
IOM labeling report? Explain why or
why not.
10. Carbohydrate
• Should the current approach for
calculating grams of total carbohydrate
by difference (see section I.E of this
document) continue to be used? Explain
why or why not. If not, what other
approach or method do you
recommend? If so, what should be
included or excluded in the current
calculation of ‘‘total carbohydrate’’?
• The 2005 Dietary Guidelines
recommends consuming fiber-rich
foods. Would the separation of dietary
fiber from the ‘‘total carbohydrate’’
declaration in nutrition labeling affect
consumer understanding of label
information and its application to
dietary guidelines and what would be
the impact, if any, on fiber
consumption?
• Should ‘‘sugars’’ continue to be
included in the Nutrition Facts label?
• Should additional types of
carbohydrate (e.g., starch) be listed
separately in the Nutrition Facts label?
Explain why or why not.
• Should carbohydrates be classified
and declared in nutrition labeling based
on their chemical definition or on their
physiological effect? Explain why you
have chosen a particular approach and
why it is preferable to the other
approach. If based on a physiologic
effect, should the DV for carbohydrate
(i.e., sugars and starch) be based on the
midpoint of the AMDR (i.e., 55
percent)? Explain why or why not.
Note: 55 percent of 2,000 calories/d is
1,100 calories. 1,100 calories divided by
4 calories/g would be 275 g/d.
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11. Dietary Fiber
15. Sodium
• Should FDA continue to use the
AOAC INTERNATIONAL methods to
determine dietary fiber? If not, what
other or additional methods should be
used?
• Should the IOM dietary fiber and/
or functional fiber definitions replace
the current FDA definition for dietary
fiber? Explain why or why not.
• Do you recommend another name
for functional fiber? If so, what do you
recommend and why?
• Until FDA identifies functional
fibers and analytical methods are
established for distinguishing functional
fiber from dietary fiber, should total
fiber be used on the label to represent
dietary fiber? Explain why or why not.
• Should the DRV for sodium be
based on the UL for sodium (2,300 mg/
d) as suggested by the 2005 Dietary
Guidelines for Americans or should it
be based on the AI (1,500 mg/d using
the population-coverage approach)?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
• If the UL should be used, should it
be adjusted using the same approach
(population-weighted or populationcoverage) as the other DRIs? Explain
why or why not.
16. Chloride
• Should soluble and insoluble fiber
continue to be voluntary or should they
be made mandatory on the food label?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
• Should the terms soluble fiber and
insoluble fiber be changed to viscous
and nonviscous fiber, as suggested by
the IOM? Explain why or why not.
The IOM set an AI and UL for
chloride on an equi-molar basis to that
of sodium since most sodium is
consumed in the form of sodium
chloride.
• Should the DV for chloride
continue to be an RDI, or should it be
a DRV like sodium? Explain why you
have chosen a particular approach and
why it is preferable to the other
approach.
• Should the DV for chloride be based
on the same DRI (AI versus UL) as used
to set a DV for sodium? Explain why or
why not.
13. Sugar Alcohols
17. Vitamins and Minerals
• Should sugar alcohols continue to
be voluntary or should they be made
mandatory on the food label? Explain
why you have chosen a particular
approach and why it is preferable to the
other approach.
• How should the energy contribution
of sugar alcohols be represented on the
label since energy values vary (e.g., from
0.2 calories/g for erythritol to 3.0
calories/g for hydrogenated starch
hydrolysates)?
• FDA has not defined how it would
determine available energy from sugar
alcohols. What analytical methods
could be used to determine the energy
contribution of sugar alcohols?
Currently vitamin A, vitamin C,
calcium, and iron are mandatory on the
food label because they were considered
to be of public health concern.
• Are vitamin A, vitamin C, calcium,
and iron still considered to be of public
health concern? Explain why or why
not.
• Are there other micronutrients that
should be of public health concern?
Please be specific in describing what, if
any, other micronutrients are of public
health concern and why.
• For those nutrients given an AI
under the DRI process, but currently
have a DV based on an earlier RDA (e.g.,
calcium, vitamin K, vitamin D,
pantothenic acid, biotin), should the
current DV be retained or should the
newer AI be used to develop a new DV?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
• Currently there is no DV for
fluoride. Since the IOM established an
AI for fluoride, should there be a DV for
fluoride? Explain why or why not.
12. Soluble and Insoluble Fiber
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14. Protein
• Should the DRV be based on the
approach recommended in the IOM
labeling report (100 percent—(DVfat +
DVcarbohydrate))? Explain why or why not.
• Should the DRV be based on the
midpoint of the AMDR for protein (i.e.,
17 percent)? Explain why or why not.
Note: Based on 2,000 calories/d, the
DRV would be 85 g/d.
• Should the DRV for protein be
based on the EAR or RDA for protein?
Explain why you have chosen a
particular approach and why it is
preferable to the other approach.
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D. Other Questions
• Should the IUs that are currently
used for the DVs for vitamins A, D, and
E be changed to µg RAE (retinol activity
equivalents), µg, and mg a-tocopherol,
respectively? Explain why or why not.
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• Should the current DV units for
folate (µg), copper (mg), chloride (mg),
potassium (mg), and sodium (mg) be
changed to be consistent with the units
in the IOM DRI reports (folate (µg
dietary folate equivalents), copper (µg),
chloride (g), potassium (g), and sodium
(g))? Explain why or why not.
• Should the Supplement Facts label
use the same DVs as the Nutrition Facts
label, as suggested in the IOM labeling
report? Explain why or why not.
• Should absolute amounts (e.g.,
grams or milligrams) be included in the
Nutrition Facts and Supplement Facts
labels for mandatory and voluntary
nutrients? Explain why or why not.
E. Process Questions
The following question seeks
information on the process issues
related to the Nutrition and Supplement
Facts labels.
• If FDA includes functional fiber in
the Nutrition Facts labels, should FDA
develop criteria for identifying fibers
that meet the definition of functional
fiber (i.e., demonstrates a physiological
benefit)? If so, what should those
criteria be?
F. Questions on Consumer and Producer
Use and Understanding of DVs
To help determine which regulatory
options might address problems
associated with food package labels
reflecting current DVs, we request
comments including available data on
the following questions:
• In the 2002 Health and Diet Survey
(Ref. 24), respondents were asked how
they use the Nutrition Facts label. The
most common answers were as follows:
(1) To see if the product was high or low
in a specific nutrient, (2) to get a general
idea of the nutritional content of food,
and (3) to decide which brand to
purchase and to compare different food
items. Do you have information
indicating how the percent DV found in
the Nutrition Facts label facilitates any
of these uses by consumers? For which
food products and nutrients?
• Currently, a percent DV is required
for most nutrients listed in the Nutrition
Facts label. Do you have any
information indicating that there are
nutrients for which consumers would
value percent DV information, but such
nutrients are not currently found in the
Nutrition Facts label?
• Do you have information suggesting
the degree to which the percent DV is
helpful for making purchases? For
which food products? For which
nutrients?
• Do you have information suggesting
differences between the degree to which
the percent DV is helpful for making
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purchases intended for consumers 4
years of age and older, children younger
than 4 years of age, infants, and
pregnant women and lactating women?
For which food products? For which
nutrients?
The following questions address
information needed by FDA to analyze
the implications of changes in the
percent DVs on consumer and producer
behavior.
• Do you have any information
suggesting that changes in percent DV
(higher or lower), for a nutrient per
serving, would cause consumers to
reduce their consumption of some
products or product categories and
increase their consumption of other
products or product categories? If so,
changes in the percent DVs of which
nutrients would cause changes in the
consumption of which products or
product categories? Why?
• If changes in the percent DVs of
some nutrients would alter the
eligibility of some products or product
categories to make nutrient content
claims or health claims, do you have
any information suggesting that
manufacturers would reformulate or relabel some of their products in order to
make a nutrient content claim or a
health claim? If so, changes in the
percent DVs of which nutrients would
cause which products or product
categories to be reformulated in order to
make a nutrient content claim or health
claim?
• If changes in the percent DVs of
some nutrients would cause some
products or product categories to be
reformulated or re-labeled in order to
make a nutrient content claim or a
specific health claim, do you have any
information suggesting that there are
public health effects from changes in
nutrient intakes and consumption
behavior of newly reformulated or relabeled products or product categories
that make these claims? If so, what are
the public health effects from changes in
nutrient intakes and from changes in the
consumption behavior of which newly
reformulated products or product
categories?
• The length of time to comply with
any regulation requiring revision to
product labels may introduce confusion
on the part of consumers during a
transition period in which two different
percent DVs would be reflected on
labels of otherwise identically
formulated products. Do you have
information suggesting the extent to
which such confusion might exist for
compliance periods of 6 months, 12
months, and 24 months? For which food
products?
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III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
IV. 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. FDA has verified the
Web site addresses but is not
responsible for subsequent changes to
the Web sites after this document
publishes in the Federal Register.
1. National Research Council (NRC),
‘‘Recommended Dietary Allowances, Seventh
Edition,’’ Washington, DC: National
Academy Press, 1968.
2. NRC, ‘‘Recommended Dietary
Allowances, Ninth Edition,’’ Washington,
DC: National Academy Press, 1980.
3. NRC, ‘‘Recommended Dietary
Allowances, Tenth Edition,’’ Washington,
DC: National Academy Press, 1989.
4. NRC, Executive Summary, ‘‘Diet and
Health: Implications for Reducing Chronic
Disease Risk,’’ Washington, DC: National
Academy Press, pp. 1 to 20, 1989.
5. U.S. Department of Health and Human
Services, ‘‘The Surgeon General’s Report on
Nutrition and Health,’’ Washington, DC,
1988.
6. U.S. Department of Agriculture and U.S.
Department of Health and Human Services,
‘‘Nutrition and Your Health, Dietary
Guidelines for Americans,’’ Washington, DC:
Home and Gardening Bulletin No. 232, 3d
ed., U.S. Government Printing Office, 1990.
Available at https://www.health.gov/
DietaryGuidelines/1990thin.pdf.
7. U.S. Department of Health and Human
Services and U.S. Department of Agriculture,
‘‘2005 Dietary Guidelines for Americans,’’
6th ed., Washington, DC: U.S. Government
Printing Office, 2005. Available at https://
www.health.gov/dietaryguidelines/dga2005/
document/.
8. IOM, Executive Summary, ‘‘Dietary
Reference Intakes for Calcium, Phosphorous,
Magnesium, Vitamin D, and Fluoride,’’
Washington, DC: National Academy Press,
pp. 1–20, 1997.
9. IOM, Executive Summary, ‘‘Dietary
Reference Intakes for Thiamin, Riboflavin,
Niacin, Vitamin B6, Folate, Vitamin B12,
Pantothenic Acid, Biotin, and Choline,’’
Washington, DC: National Academy Press,
pp. 1 to 16, 1998.
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62171
10. IOM, Executive Summary, ‘‘Dietary
Reference Intakes for Vitamin C, Vitamin E,
Selenium, and Carotenoids,’’ Washington,
DC: National Academy Press, pp. 1 to 20,
2000.
11. IOM, Executive Summary, ‘‘Dietary
Reference Intakes for Vitamin A, Vitamin K,
Arsenic, Boron, Chromium, Copper, Iodine,
Iron, Manganese, Molybdenum, Nickel,
Silicon, Vanadium, and Zinc,’’ Washington,
DC: National Academy Press, pp. 1 to 28,
2001.
12. IOM, ‘‘Dietary Reference Intakes:
Proposed Definition of Dietary Fiber,’’
Washington, DC: National Academy Press,
2001.
13. IOM, Executive Summary, ‘‘Dietary
Reference Intakes for Energy, Carbohydrate,
Fiber, Fat, Fatty Acids, Cholesterol, Protein,
and Amino Acids,’’ Washington, DC:
National Academies Press, pp. 1 to 19, 2002.
14. IOM, Executive Summary, ‘‘Dietary
Reference Intakes for Water, Potassium,
Sodium, Chloride, and Sulfate,’’ Washington,
DC: National Academies Press, pp. 1 to 20,
2004.
15. IOM, Executive Summary, ‘‘Dietary
Reference Intakes: Applications in Dietary
Planning,’’ Washington, DC: National
Academies Press, pp. 1 to 17, 2003.
16. IOM, ‘‘Dietary Reference Intakes:
Guiding Principles for Nutrition Labeling and
Fortification,’’ Washington, DC: National
Academies Press, 2003.
17. 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,
64:221–225, 2006.
18. Beaton, G.H., ‘‘Choice of DRI Value for
Use in Nutrition Labeling.’’ Journal of
Nutrition, 137:694–695, 2007.
19. Yates, A.A., ‘‘Which Dietary Reference
Intake Is Best Suited to Serve as the Basis for
Nutrition Labeling for Daily Values?’’ Journal
of Nutrition, 136:2457–2462, 2006.
20. FDA, Center for Food Safety and
Applied Nutrition, ‘‘Nutrient Content Claims
Notifications for Choline Containing Foods,’’
(Internet address: https://www.cfsan.fda.gov/
~dms/flcholin.html), August 30, 2001.
21. Derby B., A. Levy, ‘‘Do Food Labels
Work?’’ In: Handbook of Marketing and
Society, Thousand Oaks, CA: Sage, 2000.
22. IOM, Executive Summary, ‘‘Dietary
Reference Intakes: Applications in Dietary
Assessment,’’ Washington, DC: National
Academy Press, 2000.
23. FDA, ‘‘Meeting Minutes from the
Nutrition Subcommittee of the Food
Advisory Committee Meeting on Total Fat
and Trans Fat,’’ Washington, DC, April 27 to
28, 2004. Available at https://www.fda.gov/
ohrms/dockets/ac/04/minutes/
4035m1_FinalSummaryMinutes.htm.
24. FDA, ‘‘2002 Health and Diet Survey—
Preliminary Topline Frequencies
(Weighted),’’ 2004.
This ANPRM is issued under section
201 et al. of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321 et al.) and
under authority of the Commissioner of
Food and Drugs.
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APPENDIX A
ACRONYMS USED IN THIS DOCUMENT
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AI
AMDRs
ANPRM
CV
DRIs
DRV
DV(s)
EAR
EER
ESADDIs
FDA
FLUNES
IOM
IU
NAS
NLEA
OWG
PAL
RACC
RDA
RDI
SD
TEE
U.S. RDA
UL
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Adequate Intake
Acceptable Macronutrient Distribution Ranges
Advance Notice of Proposed Rulemaking
Coefficient of Variation
Dietary Reference Intakes
Daily Reference Value
Daily Value(s)
Estimated Average Requirement
Estimated Energy Requirement
Estimated Safe and Adequate Daily Dietary Intakes
Food and Drug Administration
Food Label Use and Nutrition Education Surveys
Institute of Medicine
International Units
National Academy of Sciences
Nutrition Labeling and Education Act of 1990
Obesity Working Group
Physical Activity Level
Reference Amount Customarily Consumed
Recommended Dietary Allowance
Reference Daily Intakes
Standard Deviation
Total Energy Expenditure
U.S. Recommended Daily Allowance
Tolerable Upper Intake Level
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Federal Register / Vol. 72, No. 212 / Friday, November 2, 2007 / Proposed Rules
62174
Federal Register / Vol. 72, No. 212 / Friday, November 2, 2007 / Proposed Rules
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BILLING CODE 4160–01–C
Federal Register / Vol. 72, No. 212 / Friday, November 2, 2007 / Proposed Rules
Dated: October 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–5440 Filed 11–1–07; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–HQ–0AR–2007–0510; FRL–8485–8]
Federal Implementation Plans for the
Clean Air Interstate Rule: Automatic
Withdrawal Provisions
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
ebenthall on PROD1PC69 with PROPOSALS
AGENCY:
SUMMARY: EPA is proposing to amend
the Federal Implementation Plans (FIPs)
for the Clean Air Interstate Rule (CAIR)
to provide for automatic withdrawal of
the CAIR FIPs in a State upon the
effective date of EPA’s approval of a full
State implementation plan (SIP)
revision meeting the CAIR
requirements. EPA believes it is
appropriate for the FIP withdrawal to be
automatic because to the extent EPA
approves the State’s full CAIR SIP, this
corrects the deficiency that provided the
basis for EPA’s promulgation of the FIPs
in that State.
In the ‘‘Rules’’ section of this Federal
Register, we are issuing this action as a
direct final rule without a prior
proposed rule. If we receive no adverse
comment, we will not take further
action on this proposed rule.
DATES: Written comments must be
received by December 17, 2007.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OAR–2007–0510, by one of the
following methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
• E-mail: a-and-r-Docket@epa.gov.
Attention Docket ID No. EPA–HQ–
OAR–2007–0510.
• Fax: (202) 566–9744. Attention
Docket ID No. EPA–HQ–OAR–2007–
0510.
• Mail: EPA Docket Center, EPA West
(Air Docket), Attention Docket ID No.
EPA–HQ–OAR–2007–0510,
Environmental Protection Agency,
Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
• Hand Delivery: EPA Docket Center
(Air Docket), Attention Docket ID No.
EPA–HQ–OAR–2007–0510,
Environmental Protection Agency, 1301
Constitution Avenue, NW., Room 3334;
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Washington, DC. Such deliveries are
only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OAR–2007–
0510. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or e-mail. The www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an e-mail
comment directly to EPA without going
through www.regulations.gov your email address will be automatically
captured and included as part of the
comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters and any
form of encryption, and be free of any
defects or viruses. For additional
information about EPA’s public docket
visit the EPA Docket Center homepage
at https://www.epa.gov/epahome/
dockets.htm.
Docket: All documents in the docket
are listed in the www.regulations.gov
index. Although listed in the index,
some information is not publicly
available, e.g., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy. Publicly
available docket materials are available
either electronically in
www.regulations.gov or in hard copy at
the EPA Docket Center EPA/DC, EPA
West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
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number for the EPA Docket Center is
(202) 566–1742.
Rulemaking actions related to the
CAIR and the CAIR FIPs are also
available at the EPA’s CAIR Web site at
www.epa.gov/cair.
FOR FURTHER INFORMATION CONTACT:
Carla Oldham, Air Quality Planning
Division, Office of Air Quality Planning
and Standards, mail code C539–04,
Environmental Protection Agency,
Research Triangle Park, North Carolina
27711; telephone number: 919–541–
3347; fax number: 919–541–0824; e-mail
address: oldham.carla@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Why Is EPA Issuing This Proposed
Rule?
This document proposes to amend the
CAIR FIPs to provide for automatic
withdrawal of the CAIR FIPs in a State
upon the effective date of EPA’s
approval of a full SIP revision meeting
the CAIR requirements. We have
published a direct final rule making
such amendments in the ‘‘Rules’’
section of this Federal Register because
we view this as a noncontroversial
action and anticipate no adverse
comment. We have explained our
reasons for this action in the preamble
to the direct final rule.
If we receive no adverse comment, we
will not take further action on this
proposed rule. If we receive adverse
comment, we will withdraw the direct
final rule and it will not take effect. We
would address all public comments in
any subsequent final rule based on this
proposed rule. We do not intend to
institute a second comment period on
this action. Any parties interested in
commenting must do so at this time.
The regulatory text for this proposal is
identical to that for the direct final rule
published in the ‘‘Rules’’ section of this
Federal Register. For further
information and the detailed rationale
for this proposal, see the information
provided in the direct final rule.
II. Does This Action Apply to Me?
This action does not propose any
control requirements. It proposes to
amend the CAIR FIPs to provide for
automatic withdrawal of the CAIR FIPs
in a State upon the effective date of
EPA’s approval of the CAIR SIP for the
State. EPA promulgated the CAIR FIPs
on April 28, 2006 (71 FR 25328).
Categories and entities potentially
regulated by the CAIR FIPs include the
following:
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[Federal Register Volume 72, Number 212 (Friday, November 2, 2007)]
[Proposed Rules]
[Pages 62149-62175]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5440]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
RIN 0910-ZA30
[Docket No. 2006N-0168]
Food Labeling: Revision of Reference Values and Mandatory
Nutrients
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing this advance
notice of proposed rulemaking (ANPRM) to request comment on what new
reference values the agency should use to calculate the percent daily
value (DV) in the Nutrition Facts and Supplement Facts labels and what
factors the agency should consider in establishing such new reference
values. In addition, FDA requests comments on whether it should require
that certain nutrients be added or removed from the Nutrition Facts and
Supplement Facts labels. Comments on what factors should be considered
to update the agency's reference values will inform any FDA rulemaking
that may result from this ANPRM.
DATES: Submit written or electronic comments by January 31, 2008.
ADDRESSES: You may submit comments, identified by Docket No. 2006N-
0168, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No. and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
https://www.fda.gov/ohrms/dockets/default.htm, 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.fda.gov/ohrms/dockets/default.htm
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: Paula R. Trumbo, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2579, or e-
mail: Paula.Trumbo@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Development of Current DVs
B. Nutrient Content Final Rule
C. Labeling of Dietary Supplements
D. IOM DRIs and Acceptable Macronutrient Distribution Ranges
E. IOM Report on Guiding Principles for Nutrition Labeling
F. IOM Report on the Definition of Fiber
G. Current Regulations on Trans Fat
H. ANPRM on Prominence of Calories
I. Carbohydrate Content of Food
J. ``2005 Dietary Guidelines for Americans''
II. Agency Request for Information
A. Approach for Setting DVs
B. Populations for Which the DVs are Intended
C. Labeling of Individual Nutrients
D. Other Questions
E. Process Questions
F. Questions on Consumer and Producer Use and Understanding of DVs
III. Comments
IV. References
Appendix A Acronyms Used in This Document
Appendix B Examples of Nutrition Facts and Supplement Facts Labels
I. Background\1\
---------------------------------------------------------------------------
\1\A list of the acronyms cited in this ANPRM are defined in
Appendix A.
---------------------------------------------------------------------------
On November 8, 1990, the Nutrition Labeling and Education Act
(NLEA) of 1990 (Public Law No. 101-535) was signed into law (the 1990
amendments) amending the Federal Food, Drug, and Cosmetic Act (the
act). The 1990 amendments made the most significant changes in the act
and had a direct bearing on FDA's revision of nutrition labeling in
1993. The 1990 amendments added section 403(q) (21 U.S.C. 403(q)) to
the act which specified, in part, that: (1) With certain exceptions, a
food is to be considered misbranded unless its label or labeling bears
nutrition labeling; (2) certain nutrients and food components are to be
included in
[[Page 62150]]
nutrition labeling, although the Secretary of Health and Human Services
can add or delete nutrients by regulation if it is found necessary to
assist consumers in maintaining healthy dietary practices; (3)
nutrition labeling is to be provided for the most frequently consumed
varieties of raw produce (fruits and vegetables) and raw fish according
to voluntary guidelines or, if necessary, regulations; (4) a simplified
nutrition label is to be used when the food contains insignificant
amounts of most nutrients; and (5) FDA is to develop regulations
governing labeling of foods to which section 411 of the act (21 U.S.C.
350) applies (i.e., vitamin and minerals).
In response to the NLEA, FDA, in 1993, issued several rules to
modify how nutrition information is presented on food labels. When the
agency issued those rules to modify the nutrition label information, it
considered the diet and health information that was current at that
time, including the National Academy of Sciences (NAS) Recommended
Dietary Allowances (RDAs) (Refs. 1 to 3), the NAS Diet and Health
Report (Ref. 4), the Surgeon General's Report on Nutrition and Health
(Ref. 5), and the 1990 Dietary Guidelines for Americans (Ref. 6). New
information has since become available on nutrient values that the
agency believes may impact what nutrients it should consider requiring
to be listed on the food label and what nutrient values it should use
as a basis for the DVs on the food label. The new information includes
revisions to the Dietary Guidelines for Americans (Ref. 7), the
Institute of Medicine's (IOM's) published reports on the Dietary
Reference Intakes (DRIs) that update recommendations for the intake of
vitamins, minerals, and macronutrients (Refs. 8 to 14), the IOM report
on the application of the DRIs (Ref. 15), and the IOM report on
``Guiding Principles for Nutrition Labeling and Fortification'' that
provides recommendations on the use of the new DRIs in nutrition
labeling (Ref. 16). The latter reports stimulated extensive discussion
in the scientific community (e.g. at nutrition and food science
conferences and in publications (Refs. 17 to 19); FDA and the IOM
recognize that the approach to setting a DV in the labeling report
(Ref. 16) represents a new approach that requires evaluation. At the
IOM's 2007 workshop on ``The Development of DRI's 1994-2004: Lessons
Learned and New Challenges,'' there was discussion about the
limitations of the framework that was used to set the DRIs, as well as
recommendations for future consideration. For all of these reasons, FDA
finds it important to seek comment on the recommendations made in these
reports (Refs. 7 to 16). In addition, the agency is considering changes
to the food label in more recently published ANPRMs concerning
prominence of calories and the labeling of trans fats. The agency
discusses, below, the 1993 rules on food labeling, these ANPRMs, and
publications and reports available since 1993, to provide background
for the questions the agency is asking in this ANPRM related to a
future proposed rule to update the presentation of nutrients and
content of nutrient values on food labels.
A. Development of Current DVs
In the final rule on Food Labeling; Reference Daily Intakes and
Daily Reference Values (the 1993 RDI/DRV final rule) (58 FR 2206,
January 6, 1993), FDA amended its regulations to establish two sets of
label reference values: Reference Daily Intakes (RDIs) and Daily
Reference Values (DRVs) for use in declaring the nutrient content of a
food on its label or labeling. These two reference values were used to
establish a single set of label reference values known as the DVs,
which were intended to assist consumers in both understanding the
relative significance of nutritional information in the context of a
total daily diet and in comparing the nutritional values of food
products.
1. RDIs
In the Federal Register of July 19, 1990 (55 FR 29476), FDA
proposed to replace the U.S. Recommended Daily Allowances (U.S. RDAs)
as the reference values for certain vitamins and minerals used in
nutrition labeling of foods with updated and expanded reference values
(the 1990 proposal). The U.S. RDAs set in 1973 were based primarily on
the NAS 1968 RDA values for vitamins and minerals (Ref. 1). However,
the U.S. RDAs for certain vitamins and minerals for which no RDA had
been identified (biotin, pantothenic acid, copper, and zinc) were based
on information cited in the NAS's ``Recommended Dietary Allowances,''
7th edition (Ref. 1). The NAS RDAs were updated in 1974 and 1980, and
again in 1989 along with revised values for the listing known as
``Estimated Safe and Adequate Daily Dietary Intakes'' (ESADDIs).\2\ In
1990, FDA decided that it needed to update the U.S. RDA values, in
part, due to the revisions of the 1989 NAS RDA and ESADDI values. FDA
proposed to redesignate ``U.S. RDAs'' as ``RDIs,''\3\ and to establish
five sets of RDIs for different developmental groups, i.e., adults and
children 4 or more years of age (excluding pregnant or lactating
women), children less than 4 years of age, infants, pregnant women, and
lactating women. FDA also proposed using a population-weighted average
of the relevant NAS RDAs and ESADDIs to establish the RDIs because it
would ``serve the purpose of providing an overall reference value for
food labeling more appropriately than a highest value'' and ``because
of decreasing public health concern with nutritional deficiencies, it
makes less sense to use maximum values as the basis for these reference
values'' (55 FR 29476 at 29478).
---------------------------------------------------------------------------
\2\The ESADDIs are nutrient values set by NAS for essential
nutrients for which data are available to estimate a range of
requirements, but insufficient for developing a specific RDA (Ref.
3).
\3\In 1993, FDA redesignated the term U.S. RDA to RDI because
the term U.S. RDA was easily confused with the term RDA (58 FR 2206
at 2207).
---------------------------------------------------------------------------
In the 1993 RDI/DRV final rule, FDA redesignated the U.S. RDA
values in part 101 (21 CFR part 101) for vitamins and minerals as RDIs.
In addition, FDA established, under 21 CFR part 104, a single set of
label reference values for adults and children 4 or more years of age,
in part, because of space constraints on the food label and the fact
that children over the age of 4 years consume the same foods that the
rest of the population consumes (58 FR 2206 at 2213). These RDIs were
based on the NAS RDAs set in 1968. Although FDA proposed in 1990 to
base the RDIs on a population-weighted average of the RDAs and ESADDIs,
in the 1993 RDI/DRV final rule FDA used the highest RDA for adults and
children 4 or more years of age (excluding values for pregnant and
lactating women) to serve as label reference values (58 FR 2206 at 2210
to 2213). FDA found that there was considerable and uniform support in
the comments for continuing to select the highest nutrient value from
this group and that vulnerable or at-risk groups would be sufficiently
covered by electing the highest value. FDA referred to this approach as
the ``population-coverage approach.''
On October 6, 1992, Congress passed the Dietary Supplement Act of
1992 that, in section 203, instructed FDA to not issue regulations
before November 8, 1993, that would revise the U.S. RDAs (redesignated
as RDIs) for vitamins or minerals (other than existing regulations that
established the U.S. RDAs specified in Sec. 101.9(c)(7)(iv) that were
in effect prior to October 6, 1992). Thus, FDA did not codify new
nutrient values in the 1993 RDI/DRV final rule. In the Federal Register
of December 28, 1995 (60 FR 67164) (the 1995 final rule), FDA amended
certain
[[Page 62151]]
RDIs based on the 1989 NAS RDAs and ESADDIs.
In the 1995 final rule, FDA amended its regulations to establish
RDIs for vitamin K and selenium based on the 1989 NAS RDAs, and for
manganese, chromium, molybdenum, and chloride based on the 1989 ESADDIs
(Ref. 3). FDA did not establish a DV for fluoride in the 1995 final
rule because the 1989 NAS RDA report stated that published studies ``do
not justify a classification of fluorine\4\ as an essential element,
according to accepted standards'' (Ref. 3 at p. 235) and because the
primary sources of dietary fluoride (e.g., community water supplies,
toothpastes, mouth rinses) are not required to bear nutrition labeling
(60 FR 67164 at 67168). FDA concluded that the declaration of percent
DV of fluoride within nutrition labeling on a limited number of foods
that are relatively minor sources of the nutrient would be of little
use in assisting consumers in maintaining healthy dietary practices (60
FR 67164 at 67168).
---------------------------------------------------------------------------
\4\Fluoride is the ionized form of the element fluorine.
---------------------------------------------------------------------------
In addition, a notification was submitted under section
403(r)(2)(G) of the act (21 U.S.C. 343(r)(2)(G)) in 2001 for the use of
certain nutrient content claims for choline. These statements identify
the daily value for choline as 550 milligrams (mg).\5\ This value is
based on the Adequate Intake (AI) set by the Institute of Medicine
(IOM) of the NAS in 1998 (Refs. 9 and 20).
---------------------------------------------------------------------------
\5\FDA has not acted to prohibit or modify the claims, and
therefore, manufacturers may use the specified claims on the label
and in the labeling of any food or dietary supplement product that
qualifies for the claims described in the notification.
---------------------------------------------------------------------------
2. DRVs
The 1993 RDI/DRV final rule also identified DRVs for those
nutrients that are important to diet and health (e.g., total fat,
saturated fat, cholesterol, total carbohydrate (CHO), protein, dietary
fiber, sodium, and potassium). The DRVs are based on the NAS Diet and
Health Report (sodium, potassium, fat, saturated fat, cholesterol,
carbohydrate, and dietary fiber) (Ref. 4), the Surgeon General's Report
on Nutrition and Health (dietary fiber) (Ref. 5), and the 1990 Dietary
Guidelines for Americans (Ref. 6). The DRV for protein (50 grams per
day (g/d)) was set at 10 percent of 2,000 calories based on an adjusted
average of the 1989 RDA (Ref. 3). The use of ``calories'' to mean
``kilocalories'' (kcals) is commonly accepted and more readily
understood by consumers.
The DRVs in the 1993 RDI/DRV final rule (58 FR 2206) were based on
a 2,000 calorie reference diet. In the 1990 proposal (55 FR 29476 at
29482), FDA proposed using a 2,350 calories reference diet based on a
population adjusted mean of recommended calorie allowances for persons
4 or more years of age (excluding pregnant and lactating women) (from
table 3-5 of the 10th edition of ``Recommended Dietary Allowances''
(Ref. 3)). However, FDA received several comments opposing the 2,350
reference values because of concerns that this value was too high,
especially among women (58 FR 2206 at 2217). In addition, several
comments suggested that using 2,000 calories as a reference diet would
be easier for consumers to use in calculations and closer to caloric
requirements of older women who are ``at risk for excessive calories
and fat'' (id.). The 2,000 calorie reference diet FDA adopted was
consistent with the ``population-coverage approach'' as it selected a
lower calorie basis for the DRVs for the group at risk (i.e., older
women).
B. Nutrient Content Final Rule
In the Federal Register of January 6, 1993 (58 FR 2079), FDA
published a final rule entitled ``Food Labeling: Mandatory Status of
Nutrition Labeling and Nutrient Content Revision, Format for Nutrition
Label'' (the 1993 nutrient content final rule). The 1993 nutrient
content final rule: (1) Requires nutrition labeling on most foods that
are regulated by FDA, (2) revises the list of required nutrients and
food components and the conditions for declaring them in nutrition
labeling, (3) specifies a new format for declaring nutrition
information, (4) allows specified products to be exempt from nutrition
labeling, and (5) prescribes a simplified form of nutrition labeling
and the circumstances in which such simplified nutrition labeling can
be used. An example of a Nutrition Facts label can be found in appendix
B.
1. Required and Voluntary Labeling of Nutrients on Food Products (Sec.
101.9(c))
With respect to nutrition labeling of foods, the 1993 nutrient
content final rule declared that nutrition information on the label and
in labeling of foods shall contain information about the level of the
following nutrients: (1) Calories or total calories; (2) calories from
fat; (3) calories from saturated fat (voluntary); (4) total fat; (5)
saturated fat; (6) polyunsaturated fat (voluntary); (7) monounsaturated
fat (voluntary); (8) cholesterol; (9) sodium; (10) potassium
(voluntary); (11) total carbohydrate (including sugars (mono- and
disaccharides), oligosaccharides, starch, fiber, and organic acids);
(12) dietary fiber; (13) soluble fiber (voluntary); (14) insoluble
fiber (voluntary); (15) sugars; (16) sugar alcohol (voluntary); (17)
other carbohydrate (voluntary); (18) protein; and (19) vitamins and
minerals (see Sec. 101.9(c)(1) through (c)(8)). However, those
nutrients that can be declared voluntarily, as described previously in
this document, must be declared when a nutrient content or health claim
is made (Sec. 101.9(c)). In the Federal Register of July 11, 2003 (68
FR 41434), FDA amended its regulations on nutrition labeling to require
trans fatty acids be declared in grams per serving in the nutrition
label of conventional foods and dietary supplements (see section G).
Nutrient information for both mandatory and any voluntary nutrients
that are to be declared in the nutrition label, except vitamins and
minerals, shall be declared with the name of each nutrient, and the
quantitative amount by weight for that nutrient (i.e. g or mg) (see
Sec. 101.9(d)(7)(i)). A listing of the percent DRV as established in
Sec. 101.9(c)(7)(iii) and (c)(9) (see table 1 of this document for
reference values) is required under the heading percent DV for each
nutrient for which a DRV was established, except that the percent for
protein may be omitted (see Sec. 101.9(d)(7)(ii)).
The regulations require that information about these nutrients be
declared on the nutrition label and that no nutrients or food
components, other than those listed, may be included on the nutrition
label (Sec. 101.9(c)).
A statement about the percent of the RDI, expressed as the percent
of the DV for vitamin A, vitamin C, calcium, and iron, in that order,
is required (see table 1 of this document for reference values) (Sec.
101.9(c)(8)(ii)). These four vitamin and mineral nutrients are required
to be declared because of public health concerns relative to inadequate
intake of these nutrients by specific portions of the population, as
well as the possible association between the lack of several of these
nutrients in the diet and the risk of chronic disease (58 FR 2079 at
2106). The declaration of other vitamins and minerals that have an RDI
is required when they are added as a nutrient supplement or when a
claim is made about them (Sec. 101.9(c)(8)(ii)). If the amount of the
vitamin or mineral is present at less than 2 percent of the RDI,
declaration of an amount is not required or the content may be
expressed as zero (Sec. 101.9(c)(8)(iii)).
[[Page 62152]]
Table 1.--Reference Values for Nutrition Labeling (Based on a 2,000
Calorie Intake; for Adults and Children 4 or More Years of Age)
------------------------------------------------------------------------
Nutrient\1\ Unit of Measure Daily Values
------------------------------------------------------------------------
Total Fat g 65
------------------------------------------------------------------------
Saturated fatty acids g 20
------------------------------------------------------------------------
Cholesterol mg 300
------------------------------------------------------------------------
Sodium mg 2,400
------------------------------------------------------------------------
Potassium mg 3,500
------------------------------------------------------------------------
Total carbohydrate g 300
------------------------------------------------------------------------
Fiber g 25
------------------------------------------------------------------------
Protein g 50
------------------------------------------------------------------------
Vitamin A International Units (IU) 5,000
------------------------------------------------------------------------
Vitamin C mg 60
------------------------------------------------------------------------
Calcium mg 1,000
------------------------------------------------------------------------
Iron mg 18
------------------------------------------------------------------------
Vitamin D IU 400
------------------------------------------------------------------------
Vitamin E IU 30
------------------------------------------------------------------------
Vitamin K micrograms (microg) 80
------------------------------------------------------------------------
Thiamin mg 1.5
------------------------------------------------------------------------
Riboflavin mg 1.7
------------------------------------------------------------------------
Niacin mg 20
------------------------------------------------------------------------
Vitamin B6 mg 2.0
------------------------------------------------------------------------
Folate microg 400
------------------------------------------------------------------------
Vitamin B12 microg 6.0
------------------------------------------------------------------------
Biotin microg 300
------------------------------------------------------------------------
Pantothenic acid mg 10
------------------------------------------------------------------------
Phosphorus mg 1,000
------------------------------------------------------------------------
Iodine microg 150
------------------------------------------------------------------------
Magnesium mg 400
------------------------------------------------------------------------
Zinc mg 15
------------------------------------------------------------------------
Selenium microg 70
------------------------------------------------------------------------
Copper mg 2.0
------------------------------------------------------------------------
Manganese mg 2.0
------------------------------------------------------------------------
Chromium microg 120
------------------------------------------------------------------------
Molybdenum microg 75
------------------------------------------------------------------------
Chloride mg 3,400
------------------------------------------------------------------------
\1\Nutrients in this table are listed in the order in which they are
required to appear on a label in accordance with Sec. 101.9(c). This
list includes only those nutrients for which a DRV has been
established in Sec. 101.9(c)(9) or a RDI in Sec. 101.9(c)(8)(iv).
The declaration of other vitamins and minerals with an RDI need not
be declared if: (1) Neither the nutrient nor the component is otherwise
referred to on the label or in labeling or advertising and (2) the
vitamins and minerals are required or permitted in a standardized food
(e.g., thiamin, riboflavin, and niacin in enriched flour) and included
in a food solely for technological purposes and declared only in the
ingredient statement (Sec. 101.9(c)(8)(ii)). Foods that are
represented or purported to be for use by infants (up to 12 months of
age), children 1 to 4 years of age, pregnant women, or lactating women
must use the RDIs that are specified for the intended group (Sec.
101.9(c)(8)(i)). However, FDA has not codified RDI values to use for
these various groups. FDA stated, in the 1995 final rule, that it
intended to address the issue of RDIs for all nutrients for the various
age groups in a future rulemaking but was not doing so in that rule due
to the continuing questions about how to arrive at such values. FDA
noted that, for conventional foods, there could be no declaration on
labels of foods represented or purported to be for use by infants,
children less than 4 years of age, or pregnant or lactating women for
vitamin K, selenium, chloride, manganese, chromium, and molybdenum
until such time as RDIs are established for such groups (60 FR 67164 at
67171). FDA stated that these six nutrients could be specified in mg or
[micro]g amounts in dietary supplements under Sec. 101.36 with an
asterisk in the percent DV column that refers to a footnote stating
``Daily Value not established.''
Prior to the 1995 final rule, FDA noted in the 1993 RDI/DRV final
rule that manufacturers have continued to use the nutrient values that
were contained in 21 CFR 105.3(b) (FDA deleted this paragraph on March
16, 1979 (44 FR 16005)), as label reference values for use on foods
purported or represented to be for use by infants, children under 4
years of age, or pregnant or lactating women, without objection from
FDA (58 FR 2206 at 2213). The RDIs for the vitamins and minerals for
these groups are listed in a table in the 1993 RDI/DRV final rule as
guidance (58 FR 2206 at 2213). Such table does not include the seven
nutrients that FDA stated could not be on conventional food labeling
for these specific groups in the 1995 final rule. Section
101.9(c)(8)(i) states that all other foods must use the RDI for adults
and children 4 or more years of age.
2. Application of DVs
Section 403(q) of the act provides discretion to the agency to
require information about nutrients on the food label when the agency
determines such information will ``assist consumers in maintaining
healthy dietary practices.'' Section 2(b)(1)(A) of the 1990 amendments
states 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 context of a
total daily diet.'' In the 1993 nutrient content final rule, FDA stated
that ``the nutrition label can and should help consumers make informed
food choices, and that it can also contribute to consumers maintaining
healthy dietary practices'' (58 FR 2079 at 2114). While the DVs do not
represent dietary goals for individuals, their intended use is to
provide an overall population reference value on the food label for the
consumer (55 FR 29476 at 29481).
In order to determine a nutrition labeling format that could be
used most effectively by consumers, FDA conducted consumer research and
evaluated research conducted by others in considering requirements for
the nutrition label format in the 1993 nutrient content final rule (58
FR 2079 at 2115-2121). Based on the results of several consumer studies
that evaluated the ability of nutrition label formats to enable
consumers to understand the relative significance of product nutrition
information in the context of a total daily diet, FDA concluded the
following: (1) The declaration of nutrient amount information as
percentages of DV or the placement of adjectives (e.g., high, medium,
or low) next to the nutrient amount information are effective ways to
help consumers understand the significance of product nutrition
information in the context of the total daily diet; (2) the percent DV
declarations moderate dietary judgments about a food; and (3) other
format elements, such as a list of DRVs
[[Page 62153]]
for important macronutrients, highlighting, or grouping nutrients
according to Dietary Guidelines for Americans, did not help consumers
to make better dietary judgments (58 FR 2079 at 2118). Upon reviewing
the results of several studies that evaluated the consumer's use of the
nutrition label, the two most reported uses identified by FDA were to
evaluate nutrition characteristics of single products and to assist in
making choices between products (58 FR 2079 at 2121 and references
cited therein).
Informed choices include making judgments about a food product's
contribution to the total diet and making comparisons between the
nutritional quality of different food products. Findings from the FDA
Food Label Use and Nutrition Education Surveys (FLUNES) conducted in
1994 and 1995 showed that more than half of consumers used the
Nutrition Facts label to make a judgment about the overall nutritional
quality of a food product, especially the fat content (Ref. 21).
3. Uses of the DVs in Nutrient Content and Health Claims
The DVs are used to determine, in part, whether a food or dietary
supplement is eligible to bear nutrient content claims or health
claims. For nutrient content claims, a food or dietary supplement must
contain 10 to 19 percent of the DV per Reference Amount Customarily
Consumed (RACC) in order to be labeled as a good source of a particular
nutrient and must contain 20 percent or more of the DV per RACC in
order to be labeled as an excellent source of a particular nutrient
(Sec. 101.54(b) and (c)). When a health claim is about the effects at
decreased dietary intake levels (i.e., low claim), the levels must meet
the definition for use of the term low that has been established for
that substance, unless a specific alternative level has been
established (Sec. 101.14(d)(2)(vi)). If no definition for low has been
established, the level of the substance must meet the level established
in the regulation authorizing the claim. For health claims, when a
claim is about the effects of consuming the substance at other than
decreased dietary levels (i.e. not a low claim), a food must meet the
definition of high (20 percent of the DV) for the substance that is the
subject of the claim, if the agency has established a definition for
the use of the term ``high'' for that substance and the agency has not
established an alternative level for that nutrient in the health claim
regulation (Sec. 101.14(d)(2)(vii)). For a few health claims
authorized in Sec. Sec. 101.76, 101.78, and 101.79, an eligibility
requirement is based upon meeting the definition for a good source (10
percent) of the DV for a particular nutrient. The specific eligibility
requirements for each authorized health claim are set forth in subpart
E, Sec. Sec. 101.70 to 101.83. In addition, foods bearing health
claims, other than dietary supplements or where otherwise provided for
in regulations, must contain 10 percent or more of the DV, prior to any
nutrient addition, for one of the following nutrients: Vitamins A,
vitamin C, iron, calcium, protein, or fiber (Sec. 101.14(e)(6)).
C. Labeling of Dietary Supplements
As part of the implementation of the Dietary Supplement Health and
Education Act of 1994, FDA issued final regulations in the Federal
Register of September 23, 1997 (62 FR 49826), requiring that a
Supplement Facts label appear on the label or labeling of all dietary
supplements. The Supplement Facts label is similar to the Nutrition
Facts label in both content and format. Examples of Supplement Facts
labels can be found in appendix B. The Supplement Facts label must
include the amount and percent DV of the same nutrients that are
required for conventional foods if the nutrients are present in the
supplement, as well as the amount of other dietary ingredients present
(Sec. 101.36(b)). Nutrients that have established DVs are listed
first, followed by a horizontal line that separates these nutrients
from dietary ingredients that have no DVs (e.g., botanicals). The
Supplement Facts label must state that percent DVs have not been
established for these dietary ingredients and must indicate these
ingredients clearly with an asterisk (*) (Sec. 101.36(b)(3)(iv)).
D. IOM DRIs and Acceptable Macronutrient Distribution Ranges
Beginning in 1997, the IOM began publishing a series of reports on
reference intake values (Refs. 8 to 14), collectively known as the
DRIs. The DRIs are defined intake levels and include the AI, estimated
average requirement (EAR), RDA, and the tolerable upper intake level
(UL). DRIs were set for those vitamins, minerals, and macronutrients
that are essential in humans and/or provide a beneficial role in human
health. While many of the RDAs were revised for nutrients that had an
existing RDA (e.g., iron and vitamin A), some nutrients that had RDAs
now have an AI (e.g., calcium and vitamin K). Those nutrients that had
an ESADDI, now have either an RDA (copper and molybdenum) or an AI
(manganese, fluoride, and chromium). Although not considered to be a
DRI that provides a defined intake level, the IOM also set acceptable
macronutrient distribution ranges (AMDRs) for carbohydrate (i.e.,
sugars (mono-, di- and oligosaccharides) and starch), total fat, n-3
and n-6 polyunsaturated fatty acids, and protein (Ref. 13 and Ref. 16
at p. 93). 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.
1. EAR
The EAR for a nutrient is defined as the daily intake value that is
estimated to meet the requirement for that nutrient, as defined by a
specific criterion of adequacy or optimal health, in half of the
apparently healthy individuals in a specific life stage and gender
group. This definition of the EAR implies a median, rather than a mean
or average. The median and mean would be the same if the distribution
of requirements followed a symmetrical distribution.
In the case of energy, the IOM set an estimated energy requirement
(EER) to represent the average dietary energy intake that is predicted
to maintain energy balance in a healthy adult of a defined age, gender,
weight, height, and physical activity level (PAL). PAL is the ratio of
total energy expenditure (TEE) divided by the basal rate of energy
expenditure. The EER equations use one of the four PAL categories:
Sedentary, low active, active, and very active. In children and
pregnant and lactating women, the EER meets the needs associated with
the deposition of tissues or secretion of milk at rates consistent with
good health.
The EAR and the EER are used for assessing nutrient intakes of
groups. For nutrients with an EAR and for the EER, the prevalence of
inadequacy in the population group for the nutrient or energy level
evaluated is usually the approximate percentage of the population
evaluated whose intakes fall below the EAR for the nutrient or the EER
(Ref. 22). The EAR for the nutrient and the EER can also be used to
plan for an acceptably low prevalence of inadequate intakes within a
group. The EAR for a nutrient and the EER should not be used as an
intake goal for the individual. Examples of planning for groups include
planning diets in an assisted-living facility for senior citizens
[[Page 62154]]
or planning menus for a school nutrition program (Ref. 15).
2. RDAs
The RDA is an estimate of the daily 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 and assuming a
normal distribution of requirements (Ref. 8). An RDA cannot be set
without an EAR. For all nutrients, except iron, the RDA was set based
on the EAR plus 2-times the standard deviation (SD) of the EAR : RDA =
EAR + 2 x SDrequirement. If data about the variability in
the EAR for a nutrient were insufficient to calculate the
SDEAR, then a coefficient of variation (CV) of 10 percent
was assumed.
If individual intakes have been observed for a large number of days
and are at the RDA, or observed intakes for fewer days are well above
the RDA, there can be a high level of confidence that the intake is
adequate. Under these conditions, RDAs can be used for assessing
intakes of individuals for nutritional adequacy. The RDA can also be
used to plan for intakes of individuals. The RDA should not be used to
plan intakes of groups. The RDA is not used to plan intakes of groups
because the median of a target intake distribution for a group will
usually exceed the RDA because the variance in usual intakes exceeds
the variance in requirements. Thus, the selection of the RDA as the
median of the target usual intake distribution for groups is not
recommended as it results in a greater percentage of inadequacy. The
IOM report on the application of the DRIs in planning diets for
individuals provided several examples of nutrient-based food guidance
systems that could be used by individuals for planning diets, including
food and supplement labels (e.g., the Nutrition Facts label) (Ref. 15).
3. AI
If there is insufficient scientific evidence to calculate the EAR
and therefore insufficient evidence on which to establish an RDA for an
essential nutrient or a nutrient that is beneficial for human health,
then an AI is determined. AIs are based on the following: (1)
Scientific evidence for requirements that is insufficient to set an EAR
(e.g., calcium, vitamin D, choline, biotin, fluoride, sodium); (2)
experimental data on risk reduction of chronic disease that are
insufficient to set an EAR (e.g., dietary fiber, potassium); or (3)
median intakes of a nutrient usually using national nutrition intake
survey data, provided there is no evidence of a deficiency of the
nutrient in the United States (e.g., pantothenic acid, vitamin K,
chromium, manganese, linoleic acid, and [agr]-linolenic acid). There is
much less certainty about an AI value than about an RDA value. The AI
for a nutrient is expected to exceed the RDA for that nutrient, and
therefore it should cover the needs of more than 97 to 98 percent of
individuals. The IOM set most AIs for young infants (0 to 6 months of
age) based on the average intake of the nutrient consumed exclusively
from breastfed infants, provided that breast milk provides a sufficient
amount of a nutrient to meet the needs of the infant. The AIs for older
infants (7 to 12 months) were set based on: (1) The average intake of
the nutrient consumed exclusively from breastfed infants and, if data
were available, average intakes of a nutrient provided by complimentary
weaning foods; and/or (2) extrapolated from the AI of younger infants;
and/or (3) extrapolated from adult AIs; and/or (4) clinical data. The
AIs for iron and zinc for older infants could not be set using intake
from breast milk because the level of iron and zinc in human milk is
not sufficient to meet their needs. For iron, zinc, and protein; EARs
and RDAs for older infants 7 to 12 months were set based upon data
regarding daily requirements.
Usual individual intakes that are equal to or above the AI can be
assumed adequate. The likelihood of inadequacy of usual intakes below
the AI cannot be determined since there is insufficient information of
the distribution of requirements. The AI can also be used to plan for
intakes of individuals (Ref. 15).
4. UL
The UL is the highest level of daily nutrient intake that is likely
to pose no risk of adverse health effects for almost all individuals in
the specific life stage group. As intake increases above the UL, there
is a potential for an increased risk of adverse effects. The UL is not
intended to be a recommended level of intake, as there is no
established benefit for healthy individuals if they consume a nutrient
in amounts exceeding the RDA or AI.
The UL can be used to estimate the percentage of the population at
potential risk of adverse effects from excess nutrient intake. The UL
can also be used to plan for usual intakes below this level for an
individual or in planning to minimize the proportion of the population
at risk of excess nutrient intake (Ref. 15).
5. AMDR
An AMDR is a range of intakes for a particular energy source (e.g.,
fat, fatty acids, carbohydrate, and protein) that is associated with
reduced risk of chronic disease while providing adequate intakes of
essential nutrients. The AMDR of a macronutrient (e.g., fat) is
expressed as a percentage of total energy intake because its
requirement is dependent on other energy sources (e.g., carbohydrate
and protein). If an individual consumes below or above this range,
there is a potential for increasing the risk of chronic diseases shown
to affect long-term health, as well as increasing the risk of
insufficient intakes of essential nutrients.
6. DRIs Set for Macronutrients and Micronutrients
Based on the review of all macronutrients and micronutrients that
are known to be essential and/or beneficial in humans, the IOM set the
DRIs that are listed for each nutrient in tables 2 to 10 of this
document. As can be seen from tables 11a and 11b of this document, the
population-coverage and population-weighted AIs for fluoride and the
population-coverage RDAs for synthetic niacin exceed the UL for
children 4 to 8 years.
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E. IOM Report on Guiding Principles for Nutrition Labeling
In 2003 the IOM committee on nutrition labeling (the IOM Committee)
considered how the DRIs can be used to develop appropriate reference
values for nutrition labeling (Ref. 16). The IOM Committee's report
recommended the following 10 guiding principles for nutrition labeling:
Nutrition information in the Nutrition Facts label should
continue to be expressed as percent DV. The concept of percent DV was
developed by FDA in response to NLEA to help consumers better
comprehend the nutritional value of food and to understand its relative
significance in the context of a daily diet. The percent DV concept was
modeled after the ``percent of U.S. RDAs'' used in 1973 labeling. The
use of the percent DV concept has been supported by consumer studies
(58 FR 2079). The IOM Committee concluded that the rationale to use
percent DV was compelling and suggested no alternative approach.
The DVs should be based on a population-weighted reference
value using census data and proportions of each life stage and gender
group. The IOM Committee's rationale for using a population-weighted
approach was that the DRIs for the various age and gender groups should
be represented by the DV of the population in the same proportions. A
DV defined this way would represent a central value of the requirement
of the base population, with individual requirements varying around
this value.
As discussed previously in this document, the population-weighted
approach is one of two approaches for setting one DV for all
individuals 4 years of age and older. Currently, FDA uses the
population-coverage approach for setting a single DV which represents
the highest recommended intake level among all life stage and gender
groups, excluding pregnant and lactating women. Although the degree of
change will differ for each nutrient, the DV would be lower using the
population-weighted approach for most nutrients when compared to a DV
derived using the population-coverage approach (see tables 11a and 11b
of this document). Note that if the DV for a nutrient is increased,
then a serving of food would have a lower percent DV on the Nutrition
Facts label.
Table 11a. Comparison of the Current DVs with the EAR, RDA, and UL Using the Population-Coverage or Population-Weighted Approach
--------------------------------------------------------------------------------------------------------------------------------------------------------
UL 4 to 8
Nutrient Unit of Measure Current DV Highest RDA Weighted RDA\1\ Highest EAR Weighted EAR\1\ years\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nutrients Assigned an EAR and RDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper mg 2.0 0.9 0.8 0.7 0.7 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Folate microg 400 400 378 330 304 400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Iodine microg 150 150 144 95 91 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Iron mg 18 18 11 8 6 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnesium mg 400 420 341 350 283 110
--------------------------------------------------------------------------------------------------------------------------------------------------------
Molybdenum microg 75 45 42 34 32 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Niacin mg 20 16 14 12 11 15
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phosphorus mg 1,000 1,250 769 1,055 640 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protein g 50 56 47 46 39 -
--------------------------------------------------------------------------------------------------------------------------------------------------------
Riboflavin mg 1.7 1.3 1.1 1.1 0.9 --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Selenium microg 70 55 52 45 43 150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thiamin mg 1.5 1.2 1.1 1.0 0.9 --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin A IU 5,000 3,000 2,511 2,100 1,768 --
--------------------------------------------------------------------------------------------------------------
microg 1,500 RE 900 RAE 754 RAE 630 RAE 531 RAE 900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin B6 mg 2.0 1.7 1.3 1.4 1.1 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin B12 microg 6.0 2.4 2.3 2.0 1.9 --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin C mg 60 90 74 75 61 650
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin E IU 30 IU -- -- -- -- --
--------------------------------------------------------------------------------------------------------------
mg [agr]- ........... 15 14 12 11 300
tocopherol
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 62163]]
Zinc mg 15 11 9.1 9.4 7.7 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Population-weighted means of life-stage and gender specific RDAs, EARs, AIs, and ULs were computed for adults and children 4 or more years of age,
using 2005 Middle Series Data from Annual Projections of the Resident Population by Age, Sex, Race, and Hispanic Origin: Lowest, Middle, Highest, and
Zero International Migration Series, 1999 to 2100 (NP-D1-A), (https://www.census.gov/population/www/projections/natdet-D1A.htm), U.S. Census Bureau,
Population Projection Program , accessed July 19, 2006. Life-stage and gender specific RDAs, EARs, AIs, and ULs were multiplied by the population
projection for the corresponding life-stage and gender group (e.g., children 4 to 8 years old, males 9 to 13 years old). Sum of these values were
divided by the total population projection for adults and children 4 or more years of age.
\2\The ULs for vitamin E, niacin, and folate apply to synthetic forms obtained from supplements, fortified foods, or a combination of the two. The ULs
for vitamin A apply only to preformed vitamin A. The ULs for magnesium represent intake from a pharmacological agent only and do not include intake
from food and water.
RE=retinol equivalents, RAE=retinol activity equivalents
Table 11b. Comparison of the Current DVs with the AIs and ULs Using the Population-Coverage or Population-Weighted Approach
--------------------------------------------------------------------------------------------------------------------------------------------------------
Weighted
Nutrient Unit Of Measure Current DV Highest AI AI\1\ Highest UL Weighted UL\1\ UL 4 to 8 years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nutrients Assigned an AI
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biotin microg 300 30 28 -- -- --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Calcium mg 1,000 1,300 1,091 -- -- 2,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chloride mg 3,400 2,300 2,150 3,600 3,536 2,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Choline mg 550\2\ 550 460 -- -- 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chromium microg 120 35 27 -- -- --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiber g 25 38\3\ 29\3\ -- -- --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Linoleic acid g -- 17 13 -- -- --
--------------------------------------------------------------------------------------------------------------------------------------------------------
[agr]-Linolenic acid g -- 1.6 1.3 -- -- --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manganese mg 2.0 2.3 1.9 -- -- 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pantothenic acid mg 10 5 5 -- -- --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potassium mg 3,500 4,700 4,622 -- -- --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sodium mg 2,400\4\ 1,500 1,410 2,300 2,265 1,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin D IU 400 600 280 -- -- --
---------------------------------------------------------------------------------------------------------
microg 10 15 7 ........... .............. 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin K microg 80 120 95 -- -- --
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fluoride mg -- 4 3 -- -- 2.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Population-weighted means of life-stage and gender specific RDAs, EARs, AIs, and ULs were computed for adults and children 4 or more years of age,
using 2005 Middle Series Data from Annual Projections of the Resident Population by Age, Sex, Race, and Hispanic Origin: Lowest, Middle, Highest, and
Zero International Migration Series, 1999 to 2100 (NP-D1-A), (https://www.census.gov/population/www/projections/natdet-D1A.htm), U.S. Census Bureau,
Population Projection Program , accessed July 19, 2006. Life-stage and gender specific RDAs, EARs, AIs, and ULs were multiplied by the population
projection for the corresponding life-stage and gender group (e.g., children 4 to 8 years old, males 9 to 13 years old). Sum of these values were
divided by the total population projection for adults and children 4 or more years of age.
\2\A notification was submitted under section 403(r)(2)(G) of the act (21 U.S.C. 343(r)(2)(G)) in 2001 for the use of certain nutrient content claims
for choline. These statements identify the daily value for choline as 550 mg (see footnote 5 of this document). This value is based on the AI set by
the IOM of the NAS in 1998 (Refs. 9 and 20).
\3\Based on AI of 14g/1,000 calories.
\4\Daily reference value to not be exceeded.
A population-weighted EAR should be the basis for DVs for
those nutrients for which EARs have been identified. The Committee's
rationale for using an EAR, rather than the RDA, to set the DV was the
Committee's belief that the EAR represents the most accurate
representation of the true contribution of food to total nutrient needs
in the general population.
Currently, the RDIs are based on RDAs, when available. There are 16
nutrients for which the DV is currently based on an RDA and now have a
new EAR and RDA.\6\ Because the RDA is 2 standard deviations greater
than the
[[Page 62164]]
EAR, a DV based on an EAR would be lower than when based on the RDA
(see table 11a of this document). The population-weighted EAR yields
the lowest values compared to population-coverage RDA, population-
weighted RDA, or population-coverage EAR (see table 11a of this
document). The population-weighted EAR can vary from as little as 21
percent lower than the population-coverage RDA for vitamin
B12, to 41 percent lower for vitamin A, to as much as 67
percent lower for iron.
---------------------------------------------------------------------------
\6\Currently there are DVs that were based on RDAs for vitamin
A, vitamin C, iron, vitamin E, thiamin, riboflavin, niacin, vitamin
B6, folate, vitamin B12, phosphorous, iodine, magnesium, zinc,
selenium, and protein.
---------------------------------------------------------------------------
If no EAR has been set for a nutrient, then a population-
weighted AI should be used as the basis for a DV.
An AI is a proxy for an RDA, however, the AI is not the equivalent
of an EAR. Thus, when an AI is set for a nutrient, there is no other
recommended intake level that is set for that nutrient. AIs were
determined for 15 nutrients (tables 2 and 3 of this document). As can
be seen in table 11b of this document, a reference value for labeling
based on a population-weighted AI is lower for most nutrients than a
reference value that is derived based on the population-coverage
approach that uses the highest AI. As discussed previously in this
document, AIs for children and adults were based on experimental data
that were not sufficient for setting an EAR or were based on median
intake levels. The IOM labeling report did not address the issue of
whether AIs based on either approach should or should
