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[Federal Register: November 2, 2007 (Volume 72, Number 212)]
[Proposed Rules]
[Page 62149-62175]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no07-16]
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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.
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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:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: http://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:
<bullet> FAX: 301-827-6870.
<bullet> 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
http://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 http://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\
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\1\A list of the acronyms cited in this ANPRM are defined in
Appendix A.
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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).
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\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).
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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).
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\4\Fluoride is the ionized form of the element fluorine.
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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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\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.
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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 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
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Total Fat g 65
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Saturated fatty acids g 20
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Cholesterol mg 300
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Sodium mg 2,400
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Potassium mg 3,500
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Total carbohydrate g 300
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Fiber g 25
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Protein g 50
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Vitamin A International Units (IU) 5,000
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Vitamin C mg 60
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Calcium mg 1,000
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Iron mg 18
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Vitamin D IU 400
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Vitamin E IU 30
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Vitamin K micrograms (microg) 80
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Thiamin mg 1.5
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Riboflavin mg 1.7
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Niacin mg 20
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Vitamin B6 mg 2.0
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Folate microg 400
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Vitamin B12 microg 6.0
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Biotin microg 300
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Pantothenic acid mg 10
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Phosphorus mg 1,000
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Iodine microg 150
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Magnesium mg 400
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Zinc mg 15
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Selenium microg 70
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Copper mg 2.0
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Manganese mg 2.0
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Chromium microg 120
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Molybdenum microg 75
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Chloride mg 3,400
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\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 SD<INF>requirement</INF>. If data about the variability in
the EAR for a nutrient were insufficient to calculate the
SD<INF>EAR</INF>, 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:
<bullet> 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.
<bullet> 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), (http://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), (http://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.
<bullet> 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
B<INF>12</INF>, 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.
---------------------------------------------------------------------------
<bullet> 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).
<bullet> 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 - (DV<INF>fat</INF> + DV<INF>carbohydrate</INF>)) 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 digestibility-corrected 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 AMDR AMDR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent of energy Grams (for 2,000 calories per
Grams (for 2,000 ------------------------------- day)\1\
Nutrient Percent of Energy calories per day) ---------------------------------
Low Midpoint High Low Midpoint High
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protein 10 50 10 22.5 35 50 112.5 175
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fat 30\2\ 65 20 27.5 35 44.4 61.1 77.7
Linoleic acid -- -- 5 7.5 10 11 17 22
[agr]-Linolenic -- -- 0.6 0.9 1.2 1.3 2 2.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carbohydrate 60 300\3\ 45 55.0 65 225\4\ 275\4\ 325\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protein by difference ................. .................... ....... 17.5 ....... ......... 87.5 .........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total energy 100 .................... ....... 100 ....... ......... .......... .........
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children Age 4 to 18 Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protein 10 50 10 20 30 50 100 150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fat 30\2\ 65 25 30 35 55.6 66 77.7
Linoleic acid -- -- 5 7.5 10 11 17 22
[agr]-Linolenic -- -- 0.6 0.9 1.2 1.3 2 2.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carbohydrate 60 300\3\ 45 55 65 225\4\ 275\4\ 325\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protein by difference ................. .................... ....... 15 ....... ......... 75 .........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total energy 100 .................... ....... 100 ....... ......... .......... .........
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 62165]]
Age 4 Years and Older (Weighted per IOM Labeling Report, Table B-4)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fat\5\ 30\2\ 65 21 28 35 46.7 62 77.7
Linoleic acid -- -- 5 7.5 10 11 17 22
[agr]-Linolenic -- -- 0.6 0.9 1.2 1.3 2 2.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carbohydrate\6\ 60 300\3\ 45 55 65 225\4\ 275\4\ 325\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protein by difference\7\ ................. .................... 34 17 0 170 85 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total energy ................. .................... ....... 100 ....... ......... .......... .........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Derived 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.
\2\Based on a Dietary Guideline recommendation of no more than 30 percent of energy from fat.
\3\Carbohydrate represents sugars, starch, fiber, and organic acids.
\4\Carbohydrate represents starch and sugars.
\5\The 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.
\6\No weighting was done for this group.
\7\Calculated using the difference (100 percent of energy - (DVfat + 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 (Sec. 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 (Sec. 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 (Sec. 101.9(c)(2)). The
IOM panel on macronutrients set AMDRs for total fat and fatty acids
linoleic and [agr]-linolenic acid (see table 12 of this document). The
IOM panel on macronutrients also set AIs for linoleic and [agr]-
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 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, [agr]-linolenic 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.
<bullet> 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).
<bullet> 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 health-promoting diet. The rationale for
this 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 health-promoting
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.
<bullet> 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
[[Page 62166]]
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.
<bullet> 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.
<bullet> 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 ([micro]g), copper (mg), sodium
(mg), potassium (mg) and chloride (mg) be changed to be consistent with
the units in the new DRI reports (vitamin A ([micro]g Retinol Activity
Equivalents), vitamin D ([micro]g), vitamin E (mg [agr]-tocopherol),
folate ([micro]g dietary folate equivalents), copper ([micro]g), 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 Enzymatic-
Gravimetric 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 (Sec. 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 Definitions\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intact,
CHOs Not Recovered Nondigestible Naturally Resistant to Specifies
Reference Nondigestible by Alcohol Mono- and Lignin Resistant Occurring Human Physiological
Animal CHOs\2\ Precipitation\3\ Disaccharides Starch Food Sources Enzymes Effect
Only
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Food and Yes Some inulin No Yes Some No No No
Drug
Administration
(USFDA),
1987\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\All definitions are assumed to include nonstarch polysaccharides.
\2\CHO = carbohydrate.
\3\Includes inulin, oligosaccharides (3-10 degrees of polymerization), fructans, polydextrose, methylcellulose, resistant maltodextrins, and other
related compounds.
\4\Method-based definition.
Source: Adapted from the IOM, ``Dietary Reference Intakes: Proposed Definition of Dietary Fiber,'' Washington, DC: National Academy Press, 2001.
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; 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 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''
[[Page 62167]]
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 (Sec.
101.9(c)(6)(i)(A)) and insoluble (Sec. 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.
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 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.
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
[[Page 62168]]
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.
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).
---------------------------------------------------------------------------
\7\The 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.
---------------------------------------------------------------------------
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:
<bullet> 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.
<bullet> Keep total fat intake between 20 and 35 percent of
calories, the AMDR for total fat.
<bullet> 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:
<bullet> Adults: Calcium, potassium, fiber, magnesium, and vitamins
A (as carotenoids), C, and E;
<bullet> 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 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.
<bullet> Should the DV be based on an EAR for those nutrients for
which an EAR has been set? Explain why or why not.
<bullet> If EARs are used to set DVs, should they be set based on
population-coverage 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.
<bullet> 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.
<bullet> If RDAs are used to set DVs, should they be set based on
population-coverage or population-weighted RDA? Explain why you have
chosen a particular approach and why it is preferable to the other
approach.
<bullet> 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 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.
<bullet> If AIs are used to set DVs, should they be set based on
population-coverage 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.
<bullet> Should the DVs continue to be used for persons 4 years of
age and older? Explain why or why not.
<bullet> 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,
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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
<bullet> Should 2,000 calories continue to be used to express
reference energy intake, as recommended in the IOM
[[Page 62169]]
labeling report? Explain why or why not.
<bullet> Should 2,500 calories also be kept on the label footnote?
Explain why or why not.
<bullet> Should the EER (Estimated Energy Requirements) be used to
express reference energy intake? Explain why or why not.
<bullet> 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.
<bullet> 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
<bullet> What data are there on how consumers use the listing of
``Calories from fat?''
<bullet> How does the listing ``Calories from fat'' adjacent to
``Calories'' affect consumers' focus on the total calories of a food?
<bullet> What are the advantages or disadvantages of eliminating
the listing for ``Calories from fat'' from the nutrition label?
<bullet> 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
<bullet> 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.
4. Total Fat
<bullet> 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.
<bullet> 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.
5. Saturated Fat
<bullet> Should the current DRV of 20g/d from saturated fat remain,
as recommended by the 2005 Dietary Guidelines? Explain why or why not.
<bullet> 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
<bullet> 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.
<bullet> 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.
<bullet> 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
<bullet> 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.
<bullet> 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.
<bullet> Should a DRV for polyunsaturated fat be derived based upon
AIs for linoleic acid (n-6 polyunsaturated fat) plus [agr]-linolenic
acid (n-3 polyunsaturated fat)? Explain why or why not.
<bullet> Should separate DRVs for linoleic acid (n-6
polyunsaturated fat) and [agr]-linolenic acid (n-3 polyunsaturated fat)
be established? Explain why or why not.
<bullet> If separate DRVs for linoleic acid (n-6 polyunsaturated
fat) and [agr]-linolenic 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
<bullet> 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
<bullet> Should the current cholesterol DRV of 300 mg/d remain, as
recommended by the ``2005 Dietary Guidelines for Americans''? Explain
why or why not.
<bullet> 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
<bullet> 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''?
<bullet> 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?
<bullet> Should ``sugars'' continue to be included in the Nutrition
Facts label?
<bullet> Should additional types of carbohydrate (e.g., starch) be
listed separately in the Nutrition Facts label? Explain why or why not.
<bullet> 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.
[[Page 62170]]
11. Dietary Fiber
<bullet> Should FDA continue to use the AOAC INTERNATIONAL methods
to determine dietary fiber? If not, what other or additional methods
should be used?
<bullet> Should the IOM dietary fiber and/or functional fiber
definitions replace the current FDA definition for dietary fiber?
Explain why or why not.
<bullet> Do you recommend another name for functional fiber? If so,
what do you recommend and why?
<bullet> 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.
12. Soluble and Insoluble Fiber
<bullet> 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.
<bullet> 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.
13. Sugar Alcohols
<bullet> 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.
<bullet> 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)?
<bullet> 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?
14. Protein
<bullet> Should the DRV be based on the approach recommended in the
IOM labeling report (100 percent--(DV<INF>fat</INF> +
DV<INF>carbohydrate</INF>))? Explain why or why not.
<bullet> 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.
<bullet> 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.
15. Sodium
<bullet> 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.
<bullet> If the UL should be used, should it be adjusted using the
same approach (population-weighted or population-coverage) as the other
DRIs? Explain why or why not.
16. Chloride
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.
<bullet> 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.
<bullet> 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.
17. Vitamins and Minerals
Currently vitamin A, vitamin C, calcium, and iron are mandatory on
the food label because they were considered to be of public health
concern.
<bullet> Are vitamin A, vitamin C, calcium, and iron still
considered to be of public health concern? Explain why or why not.
<bullet> 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.
<bullet> 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.
<bullet> 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.
D. Other Questions
<bullet> Should the IUs that are currently used for the DVs for
vitamins A, D, and E be changed to [micro]g RAE (retinol activity
equivalents), [micro]g, and mg [agr]-tocopherol, respectively? Explain
why or why not.
<bullet> Should the current DV units for folate ([micro]g), copper
(mg), chloride (mg), potassium (mg), and sodium (mg) be changed to be
consistent with the units in the IOM DRI reports (folate ([micro]g
dietary folate equivalents), copper ([micro]g), chloride (g), potassium
(g), and sodium (g))? Explain why or why not.
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> 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?
<bullet> 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?
<bullet> Do you have information suggesting the degree to which the
percent DV is helpful for making purchases? For which food products?
For which nutrients?
<bullet> 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.
<bullet> 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?
<bullet> 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 re-label 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?
<bullet> 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 re-labeled 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?
<bullet> 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?
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
http://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 http://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.
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: http://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 http://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.
[[Page 62172]]
Appendix A
Acronyms Used in This Document
AI Adequate Intake
AMDRs Acceptable Macronutrient Distribution Ranges
ANPRM Advance Notice of Proposed Rulemaking
CV Coefficient of Variation
DRIs Dietary Reference Intakes
DRV Daily Reference Value
DV(s) Daily Value(s)
EAR Estimated Average Requirement
EER Estimated Energy Requirement
ESADDIs Estimated Safe and Adequate Daily Dietary Intakes
FDA Food and Drug Administration
FLUNES Food Label Use and Nutrition Education Surveys
IOM Institute of Medicine
IU International Units
NAS National Academy of Sciences
NLEA Nutrition Labeling and Education Act of 1990
OWG Obesity Working Group
PAL Physical Activity Level
RACC Reference Amount Customarily Consumed
RDA Recommended Dietary Allowance
RDI Reference Daily Intakes
SD Standard Deviation
TEE Total Energy Expenditure
U.S. RDA U.S. Recommended Daily Allowance
UL Tolerable Upper Intake Level
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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