in people with this condition. While the IOM set an RDA of 2.4 [mu]g/d
that can be met by consuming natural and crystalline forms of vitamin
B12 and is for all adults, it was noted that it is advisable
that individuals older than 50 years of age meet their RDA mainly by
consuming foods fortified with crystalline vitamin B12 or
vitamin B12-containing supplements. If the RDI is lowered
from 6 to 2.4 [mu]g, it is possible that the fortification level in
foods, such as ready-to-eat breakfast cereals, may be lowered,
decreasing the overall amount of crystalline vitamin B12 in
the food supply. Given the current level of fortification in food, less
than 1 percent of men and 6.4 to 7.5 percent of women older than 50
years of age consume below the EAR for vitamin B12, while
only 3 to 5 percent of men and women in this age group have serum
vitamin B12 levels that are considered to be inadequate
(2003-2006 NHANES) (table 1). Reflecting the current food supply and
regulations, data from NHANES (2003-2006) indicate that ready-to-eat
cereal is the primary source of crystalline B12 added to
food, providing approximately 14.6 percent of the total vitamin
B12 consumed by individuals 51 years of age and older (Ref.
139). Dietary supplements appear to be an important contributor of
vitamin B12 for this age group because the mean increase in
vitamin B12 intake ranged between 2.5 and 4.7 [mu]g/d when
comparing intake from food only compared to food plus dietary
supplements (NHANES 2003-2006) (table 1). We request comment and data
on lowering the RDI for vitamin B12 to 2.4 [mu]g.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

L. Dietary Supplements

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

Sec.  101.36(b)(2)(i), (b)(2)(i)(B)(1), and (b)(2)(iii)(G) to remove
the requirement for declaration of ``Calories from fat.''
2. Folate and Folic Acid
    We are proposing to only allow the use of the term ``folic acid''
for the labeling of dietary supplements. Folate is a nutrient found in
conventional foods, whereas folic acid is the synthetic form of folate
that is added to fortified conventional foods and dietary supplements.
As discussed in section II.J.2., ``folic acid'' or ``folacin'' are
identified as synonyms of folate and can be used on the Nutrition Facts
label (Sec.  101.9(c)(8)(v)) or in the Supplement Facts label (Sec.
101.36(b)(2)(i)(B)(2)). However, because of the difference in
bioavailability between naturally occurring folate, and synthetic folic
acid, we are proposing to amend Sec.  101.9(c)(8)(v) such that the term
``folate'' would be used in the labeling of conventional foods that
contain either folate alone or a mixture of folate and folic acid. As
discussed in section II.J.2.c., we consider only the term ``folic
acid'' to be appropriate for use in the labeling of dietary
supplements. Therefore, we are proposing to amend Sec. Sec.
101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to specify that ``folic acid''
is the term used to declare folic acid content of dietary supplements;
and to remove ``folate'' and ``folacin'' from the list of synonyms that
may be used to declare folic acid on the Supplement Facts label.
3. Units of Measure
    In section II.J.3., we are proposing to amend Sec.  101.9(c)(8)(iv)
to replace ``IU'' for the RDIs for vitamin A, vitamin D, and vitamin E
with mcg RAE for vitamin A, mcg for vitamin D, and mg [alpha]-
tocopherol for vitamin E. In addition, in section II.J.2., we are
proposing to quantify and declare folate and folic acid in ``mcg DFE''
instead of ``mcg.'' In the interest of maintaining consistency in
nutrition labeling of foods and dietary supplements, we are proposing
to amend Sec.  101.36(b)(2)(i)(B)(3) to require that when [beta]-
carotene is included in parentheses following the percent statement for
vitamin A, it should be declared using ``mcg'' (representing mcg RAE)
as the unit of measure. In addition, under Sec.  101.36(b)(2)(ii)(B),
the proposed units of measure for vitamin D, vitamin E, and folate in
Sec.  101.9(c)(8)(iv) would be used in the declaration of vitamin D,
vitamin E, and folic acid in the Supplement Facts label.
    In 2005, we received a citizen petition (Docket No. FDA-2005-P-0126
(formerly Docket No. 2005P-0293)) requesting us to preclude the
declaration of [beta]-carotene in supplements as vitamin A (http://www.regulations.gov/# !docketDetail;D=FDA-2005-P-0126). The petition
maintained that the declaration of vitamin A on dietary supplement
labels is misleading when the supplement contains mostly [beta]-
carotene because only a small amount of [beta]-carotene is converted by
the liver into vitamin A. We do not see a need to preclude the
declaration of [beta]-carotene as vitamin A, because the difference in
the bioconversion of [beta]-carotene to vitamin A will be accounted for
with the proposed declaration of vitamin A content as ``mcg''
(representing mcg RAE) (see section II.J.3.). Therefore, we are not
proposing to preclude the declaration of [beta]-carotene in dietary
supplements as vitamin A.
4. Order of Nutrients Declared on the Label
    For dietary supplements, Sec.  101.36(b)(2)(i)(B) specifies that
vitamins and minerals must be declared in a specific order on the
Supplement Facts label. We are now proposing to establish an RDI for
choline in section I.7. Therefore, it is necessary to add choline to
the list of ordered nutrients in Sec.  101.36(b)(2)(i)(B). We are
proposing to require that, when declared, choline shall follow
potassium on the label.
5. Subpopulations
    We discussed several changes in section II.K. that will affect
dietary supplement labeling currently required for infants, children