terms to be added in parentheses after folate or listed without
parentheses in lieu of ``folate'' on the Nutrition Facts label (Sec.
101.9(c)(8)(v)) or on 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, the proposed rule would: (1) Eliminate the
synonym ``folacin'' specified in Sec. Sec.  101.9(c)(8)(v) and
101.36(b)(2)(i)(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. Thus, under the proposed rule, conventional
foods would not be permitted to use the term ``folic acid.''
    (Comment 421) One comment supported eliminating the term
``folacin'' from the Nutrition Facts and Supplement Facts labels.
However, other comments asked that we continue to allow the use of the
term ``folate'' on Supplement Facts labels. Several comments stated
that the use of the term folate on dietary supplement labels

refers to dietary folates which are members of the folate group that
can be found in food, including folinic acid (5-fomryltetrahyrofolate).
For some dietary supplements, calcium L-methylfolate (L-5 MTHF), and
various other tetrahydrofolates, as synthetic folate, may be added. In
comparison, the comments said that folic acid is synthetically produced
and refers to only one member of the folate group (pteroylmonoglutamic
acid). The comments said it would be scientifically and chemically
incorrect and misleading to consumers to refer to the reduced folate
forms in dietary supplements as folic acid, given that folic acid
represents only the monoglutamic form.
    Other comments noted there are a large number of dietary
supplements that are ``whole food'' supplements containing naturally
occurring folate rather than added folic acid (e.g., multivitamin
capsules manufactured using powdered cultured yeast).
    (Response) We agree that there are dietary supplements that may
contain natural folate from food or synthetic folate (e.g., L-5-MTHF).
If synthetic folate is added to a dietary supplement, folate must be
declared as mcg DFE folate and percent DV based on DFE. This will
result in consistency in the nutrient terms used and units of measure
for the declaration of folate on both conventional foods and dietary
supplements, which will avoid confusion among consumers. We are not
aware of a manufacturer choosing to voluntary declare naturally
occurring folate in a dietary supplement ingredient, but if not added
for the purpose of supplementation, the manufacturer is not required to
declare the quantitative amount or the percent DV for naturally
occurring folate. If a manufacturer chooses to voluntary declare
naturally occurring folate, the manufacturer must declare both the
quantitative amount in mcg DFE and the percent DV. In addition, if
folic acid is added to the dietary supplement that has naturally
occurring folate present, the quantitative amount of folate, the
quantitative amount of folic acid, and the % DV must be declared. The
terminology for the units of measure in the Supplement Facts label will
be consistent with the terminology in the Nutrition Facts label.
Therefore, the final rule removes ``folacin'' from the list of synonyms
that may be used for folate in the Nutrition Facts label in Sec.
101.9(c)(8)(v) and the Supplement Facts label in Sec.
101.36(b)(2)(i)(B)(2)). In addition, the final rule removes the term
``folic acid'' from the list of synonyms that may be added in
parentheses immediately following ``folate'' on the Nutrition Facts
label in Sec.  101.9(c)(8)(v) or in place of the term ``folate'' on the
Supplement Facts label in Sec.  101.36(b)(2)(i)(B)(2) because we are
now requiring that both the terms ``folate'' and ``folic acid'' be
included, when declared, on both the Nutrition and Supplement Facts
label.
    (Comment 422) Several comments suggested that not allowing the use
of the term ``folate'' on Supplement Facts labels and not considering
L-5 MTHF calcium (Metafolin) to be equivalent to folic acid would have
devastating, negative effects on industry. The comments said that
eliminating the term ``folate'' would prevent dietary supplement
manufacturers from being able to use L-methylfolate in their products.
Other comments said we should clarify how L-5 MTHF should be labeled.
    (Response) The final rule requires the use of the term ``folate''
on Supplement Facts labels and achieves consistency between the
Supplement Facts and Nutrition Facts labels.
    We also intend to consider the comparability of synthetic folates
(e.g., L-5-MTHF calcium (metafolin)) in dietary supplements and the
need for a conversion factor for each in a separate rulemaking. In the
interim, manufacturers of synthetic folates, such as calcium and/or
glucosamine salts of L-5- MTHF may use their established conversation
factors (not to exceed 1.7 (comparable to folic acid)) when reporting
mcg DFE, and we can determine what conversion factor is being used
through information obtained from records required by this final rule
for natural folate, folic acid, and synthetic folate present in the
product and the declared folate mcg DFE on the label.
    (Comment 423) Some comments stated that limiting the use of the
term ``folate'' to conventional food only would effectively make drug
companies the only source for people who have a genetic polymorphism in
the MTHFR gene. Some comments stated that it is important and essential
that the labeling of dietary supplements explicitly state the form or
forms of folate they contain because many people are not able to
convert folic acid to folate. The comments added that, although there
is no agreement regarding the number of people whose bodies have
difficulty converting folic acid to folate, there is agreement that it
is a serious concern for many individuals. The comments said there is
much knowledge available regarding defects in two deoxyribonucleic acid
(DNA) sequences responsible for producing enzymes needed for the final
stage of conversion of folic acid into the active form needed by the
human body and that these defects relate to an enzyme called MTHFR and
are very common, although the defects vary enormously between ethnic
groups and regions. The comments said that the defects can be found in
as many as 44 percent of North American Caucasians and over 50 percent
of Italians and are more common among those predisposed to diseases
such as cancer, heart disease, and autism. The comments said that these
estimates do not account for mutations in other genes involved in
folate metabolism, such as DHFR, where data have only been emerging
recently. For individuals who have mutations impacting MTHFR or other
genes relating to folate metabolism, the comments said there is a
distinct possibility of building up too much un-metabolized folic acid
thereby potentially increasing the risk of cancer, heart disease or
stroke. Consequently, a substantial segment of the population needs to
consume folate rather than folic acid and would not be able to process
dietary supplements containing folic acid.
    Several comments stated that requiring dietary supplement labels to
use the term ``folic acid,'' when the product only contains folates
found in food, would mislabel the product.
    (Response) When folic acid is added to conventional food, the final
rule requires the declaration of mcg folic acid in addition to the
declaration of folate as a percent DV based on mcg DFE or as a
quantitative amount by weight in mcg DFE and the percent DV based on
mcg DFE. When folic acid is added to dietary supplements, the final
rule requires the the quantitative amount by weight for folate (mcg DFE
folate) and the percent DV based on mcg DFE for folate, in addition to
the mcg folic acid in parentheses. This should address the comments'
concerns.
    (Comment 424) One comment would revise the rule to state that the
term ``folic acid'' should be used in the labeling of dietary
supplements, but that the term ``folate'' should be used if the dietary
supplement contains folates in food as opposed to folic acid. The
comment said that conventional foods would not be permitted to use the
term ``folic acid'' unless they are fortified with folic acid. The
comment said this result would be consistent with our intent to
distinguish between items containing folate and those that primarily
contain synthetic folic acid.
    Another comment would revise footnote 3 in proposed Sec.
101.9(c)(8)(iv). The proposed footnote would state that

folic acid ``must be used for purpose of declaration in the labeling of
dietary supplements'' and ``must also be declared in mcg DFE.'' The
comment would revise the footnote to say that folic acid ``must be used
for foods that contain this nutrient solely in the form of added folic
acid. Foods which supply both folate and folic acid must list the
predominant form. Folate and folic acid must both be declared in mcg
DFE. Additional information regarding the types(s) or sources(s) of the
nutrients (e.g., folate, folic acid, or L5-MTHF) and or/relative
amounts where more than one form is present, may be included in
parentheses.'' The comment also would revise Sec.  101.9(c)(8)(vii) to
require ``folate'' ``for products containing only or predominantly
folate'' and ``folic acid'' for ``products containing only or
predominantly folic acid.'' (The proposed rule would require, when the
amount of folate is declared in the labeling of a conventional food,
the use of the name ``folate'' for products containing either folate
alone or a mixture of folate and folic acid and the use of the term
``folic acid'' when the nutrient is declared in the labeling of a
dietary supplement.) The comment also would revise the rule to say that
additional information regarding the types(s) or sources(s) of the
nutrients (e.g., folate, folic acid, or L-methylfolate) and or/relative
amounts where more than one form is present, may be included in
parentheses.
    (Response) The final rule requires the use of the term ``folate''
on Supplement Facts labels when folic acid or synthetic folate is added
and must be declared and when naturally occurring folate is present and
may be declared. The final rule also requires the use of the term
``folic acid'' in mcg folic acid when folic acid is present. This
achieves consistency in terminology between the Supplement Facts and
Nutrition Facts labels. If folic acid is declared, manufacturers of
dietary supplements must also declare the quantitative amount of
folate. The mcg DFE reflects the higher bioavailability of folic acid
and certain synthetic folate (e.g., L-5-MTHF) than that of food folate
and is the basis of DV.
    Under the Supplement Facts label requirements at Sec.  101.36(d),
the source ingredient may be identified in parentheses immediately
following or indented beneath the name of a dietary ingredient and
preceded by the word ``as'' or ``from.'' When a source ingredient is
not identified within the nutrition label, it must be listed in an
ingredient statement in accordance with Sec.  101.4(g). However, when a
source ingredient is identified in the nutrition label, we do not
require it to be listed again in the ingredient statement. With respect
to conventional food, the only form that currently can be added to
conventional food is folic acid under Sec.  172.345 and not any other
forms. If folic acid is added to a conventional food, folic acid must
be listed in the ingredient list (Sec.  101.4(a)).
    (Comment 425) Some comments stated that not allowing the term
``folate'' on dietary supplement labels violates the First Amendment.
The comments said we cannot require that labeling to refer to folate as
folic acid because, according to the comments, such labeling would then
be false.
    (Response) The final rule requires the use of the terms ``folate''
and ``folic acid,'' when declared, on Supplement Facts labels and
achieves consistency between the terms used and units of measure in the
Supplement Facts and Nutrition Facts labels. Therefore, the comments'
First Amendment concerns are no longer applicable.
    (Comment 426) One comment said that there is sufficient theoretical
and circumstantial evidence that could compel the informed consumer to
seek dietary supplements containing methyl folate rather than folic
acid. Other comments suggested putting the term ``folate'' on
conventional foods and dietary supplement labels, and using ``folic
acid'' on dietary supplement labels with the source in parentheses
(e.g., Folic acid as calcium l-5 methyltetrahyrofolate).
    (Response) Under the Supplement Facts label requirements at Sec.
101.36(d), the source ingredient may be identified in parentheses
immediately following or indented beneath the name of a dietary
ingredient and preceded by the word ``as'' or ``from'' (e.g., ``folate
(as L-5-MTHF-calcium)).'' When a source ingredient is not identified
within the Nutrition Facts label, it must be listed in an ingredient
statement in accordance with Sec.  101.4(g). However, when a source
ingredient is identified in the Nutrition Facts label, it will not be
listed again in the ingredient statement. For conventional food, under
Sec.  172.345, the only form that currently can be added to
conventional food is folic acid and not any other forms. If folic acid
is added to a conventional food, folic acid must be listed in the
ingredient list (Sec.  101.4(a)).
    (Comment 427) One comment stated that it is reasonable not to
permit the term folate to be used alone on dietary supplement labels
because it is not sufficiently specific. The comment added that if DFE
is used for foods, it should be used for dietary supplements as well,
but that correct calculation is uncertain. The comment suggested using
the term FAE (folic acid equivalent) instead of DFE because FAE is
based on a well-defined compound, unlike folate naturally present in
unspecified food. Furthermore, the comment said, when the folic acid
dose is sufficiently small, the biological availability is much better
defined than folate from unspecified food. The calculation of FAE would
include contribution from all folates, which would include folic acid
and L-5-MTHF salts. The comment also stated that, as understanding of
folate naturally occurring in food improved, the calculation of its
contribution to FAE can be improved.
    (Response) We address the requirements for labeling folate in our
response to comment 413.
    We disagree that the term FAE should be used on the label instead
of DFE. Based on the IOM report (IOM 1998), the correct terminology
that is accepted by the scientific community is mcg DFE and not FAE. We
will, however, monitor the science in this area and, if there are any
major changes based on the future consensus report, we will consider
whether further changes are needed.
    (Comment 428) One comment stated that, while there is consensus
that pure folic acid is more bioavailable than naturally occurring
folate in food, there is currently no scientific consensus as to the
magnitude of this effect. The comment said that one recent review
states that the bioavailability of food folate is commonly estimated at
50 percent of folic acid bioavailability, but said this should be
considered a rough estimate because the data on the bioavailability of
food folate vary between 30 and 98 percent. The comment noted that,
even if a dietary supplement's direction for use specifies taking the
products with food or alone, many consumers may not comply. The comment
also stated that the more precise estimates (i.e., based on consumption
of the nutrient in fortified food or a supplement taken with food vs.
supplement taken alone) are not justified by the available data. The
comment said that our proposed definition, based on IOM recommendations
dating to 1998, no longer represents current knowledge and developments
in the formulation of foods and supplements accurately. The comment
would revise the definition to assign a value to naturally occurring
folate at 50 percent of the value of folic acid (as well as at 50
percent of the value of L-MTHF salts on the equimolar basis to folic
acid.
    The comment also would revise footnote 4 in Sec.  101.9(c)(8)(iv).
As

proposed, the footnote would explain that DFE stands for ``Dietary
folate equivalents'' and that 1 DFE equals 1 microgram food folate and
equals 0.6 micrograms folic acid from fortified food or as a supplement
consumed with food equals 0.5 micrograms of a supplement. The comment
would revise the footnote to capitalize the first letters in ``folate
equivalents'' and to state that ``1 DFE = 1 mcg naturally occurring
folate = 0.5 mcg folic acid (anhydrous basis)* = 0.56 mcg of L-
methylfolate calcium salt (anhydrous basis, molecular weight of
497.5))* = 0.93 mcg L-methylfolate glucosamine salt (anhydrous basis,
molecular weight of 817.8))*. With respect to the asterisks, the
comment said that, because these numbers will often be calculated
rather than determined through testing, it is important to specify how
water present in the ingredient is to be accounted for in the
calculation.
    (Response) We disagree that we should assign the value of naturally
occurring folate at 50 percent of the value of folic acid (folic acid
multiply by 2 instead of 1.7). We agree that the bioavailability of
food folate at 50 percent of the bioavailability of folic acid is
considered a rough estimate, as data on the bioavailability of food
folate may vary between 30 percent and 98 percent. While we recognize
that the IOM recommendation dates to 1998, it remains the best
scientific consensus report that is available now. We will monitor the
science in this area and, if there are any changes based on the future
consensus report, we will consider whether to make modifications.
    In regard to taking into account the weights of the salts in the
formula weights of the available 5-MTHF derivatives, label values and
requirements are presented on labels on a weight basis (e.g., mg of
calcium, rather than molar equivalents of calcium). Manufacturers are
responsible for calculating amounts of the salt forms that, when added,
will provide accurate amounts of folate for the label declaration. This
is routinely done with other compounds such as minerals (e.g., for
calcium, the label states the amount of calcium, not the amount of
calcium carbonate that is added).
    As for the footnote pertaining to DFE in Sec.  101.9(c)(8)(iv), we
have revised it to read as follows: ``DFE = Dietary Folate Equivalents;
1 DFE = 1 mcg naturally occurring folate = 0.6 mcg folic acid.''
4. Vitamins A, D, and E
    Our preexisting regulations, at Sec. Sec.  101.9(c)(8)(iv) and
101.36(b)(2)(ii)(B), require the use of International Units (IUs) for
the labeling of vitamins A, D, and E on the Nutrition and Supplements
Facts labels. The preamble to the proposed rule (79 FR 11879 at 11932)
described how changes in our understanding of vitamin activity, along
with the IOM Labeling Committee's recommendation to change the units of
measure for these nutrients to be consistent with the units in the new
DRI reports, led us to propose amending 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, mcg for vitamin D, and mg [alpha]-tocopherol for
vitamin E.
    a. General comments.
    (Comment 429) Several comments supported changing the units of
measure for vitamin A, vitamin D, and vitamin E. One comment supported
using mg because, the comment asserted, that is how most registered
dietitians give recommendations. Another comment cited a study that
reported that physicians typically prescribe vitamin and mineral
intakes in mg (Ref. 239). Other comments asked us to retain IUs rather
than change to mcg RAE, mcg vitamin D, and mg vitamin E. The comments
said that consumers are familiar with IUs and would be confused by use
of new units for these nutrients. Other comments seeking to retain IUs
as the unit of measure for vitamin D noted that IUs are used on dietary
supplements and by clinicians. Another comment requested that the unit
of measure for vitamin D be consistent for foods and supplements. One
comment supporting the continued use of IUs as a unit of measure noted
that the IOM uses IUs for vitamin D.
    Other comments recommended that we develop an educational campaign
to help consumers understand that changes in the units of measure. Some
comments suggested that we make a gradual transition to the new units
of measure, including a period during which the labels could use IUs in
addition to the new units of measure to help consumer understanding.
    (Response) We acknowledge that consumers may need some time to
adjust to the new units and consider educational activities important
to assist consumers to understand the changes made. However, unlike for
vitamins A and E, we have further considered the use of IUs for vitamin
D and have determined there are good reasons, specific to vitamin D, to
permit the voluntary labeling in IUs for vitamin D in addition to
requiring the new mcg units. First, although the IOM Labeling Report
(Ref. 25) recommended the use of mcg as the unit of measure for vitamin
D, some other IOM materials such as the IOM report on calcium and
vitamin D (Ref. 200) present both IUs and mcg as the unit of measure.
Thus, we agree, in part, with the comment noting that the IOM uses IUs
as the unit of measure. Second, we found that the majority of the U.S.
population has usual intakes of vitamin D below the EAR from
conventional foods alone, and even when combined with dietary
supplements (79 FR 11879 at 11922). Moreover, certain segments of the
U.S. population are at risk for inadequacy and may be at increased risk
of deficiency. Inadequate intakes of vitamin D are associated with
osteoporosis and osteopenia (id.). Third, there are not a wide variety
of food sources of vitamin D (79 FR 11879 at 11921), and many
individuals rely on vitamin D supplements labeled in IUs to achieve an
optimal intake, often on the advice and prescription of a clinician.
For these reasons, we have determined it is appropriate to permit the
voluntary labeling of vitamin D in IUs, in parentheses, alongside the
mandatory declaration in mcg units. In this way, the manufacturer can
determine whether to include IUs on the label for its products, based
on the use of the product and consumers who may be relying on the
advice of a clinician who recommends or prescribes vitamin D in IUs
alone, or combined with, mcg units. The reasons we provide for the need
for voluntary labeling of IUs for vitamin D are not present with
respect to vitamin A or E as the IOM is consistent in presenting units
of measure for these nutrients and we have determined them not to be
nutrients of public health significance. Therefore, we are replacing
IUs with mcg which will be consistent with the IOM Labeling Committee's
recommendation that the units of measure be consistent with the DRIs.
We agree that the unit of measure for vitamin D should be consistent
for foods and supplements. We note that the Supplement Facts label
reflects the unit of measure for vitamin D required by Sec. Sec.
101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B) thus will reflect mcg as the
unit of measure for both conventional foods and dietary supplements.
    Furthermore, we provide for voluntary labeling of vitamin D in IUs
on both conventional food and dietary supplements. Because we have
determined that vitamin D is a nutrient of public health significance,
we consider that voluntary labeling in IUs for vitamin D will assist
consumers in maintaining healthy dietary practices. The voluntary
listing of the amount of vitamin D in IUs should be listed in

parentheses next to the mcg amount for vitamin D.
    As for a transition period to the new units of measure, we note
that the final rule has a compliance date of July 26, 2018, although
the compliance date for manufacturers with less than $10 million in
annual food sales is July 26, 2019. This should give manufacturers and
consumers some time to convert to the new units of measure and also
give us some time to educate consumers about the change.
    (Comment 430) Some comments urged that we use the symbol `[micro]g'
instead of `mcg'.
    (Response) We decline to amend the rule as suggested by the
comment. While the abbreviation ``[micro]g'' may also be used for
micrograms, the use of ``mcg' instead of ``[micro]g'' may prevent
consumers from misinterpreting the prefix [micro] as m (milli).
    b. Specific comments on the units of measure for individual
vitamins. Several comments focused on the units of measure for
individual vitamins.
    (Comment 431) We proposed to change the units of measure for
vitamin A in Sec.  101.9(c)(8)(iv) by replacing ``IU'' with ``mcg,''
representing mcg Retinol Activity Equivalents (RAE). The preamble to
the proposed rule explained that the IU for vitamin A does not reflect
the carotene:retinol equivalency ratio, that the vitamin A activity of
provitamin A carotenoids (such as [beta]-carotene) is less than pre-
formed vitamin A (retinol), and that RAEs consider 6 mcg of dietary
[beta]-carotene to be equivalent to 1 mcg of purified [beta]-carotene
in supplements (79 FR 11879 at 11932). We proposed a similar change
dietary supplements in proposed Sec.  101.36(b)(2)(i)(B)(3).
    Several comments agreed with the change to mcg RAE. However, other
comments opposed changing IUs to mcg RAE; the comments said that the
change fails to distinguish between synthetic [beta]-carotene and
naturally derived [beta]-carotene in foods and supplements and results
in less vitamin A declared on supplements.
    One comment noted that we provided only RAE conversions for
retinol, beta-carotene, alpha-carotene and beta-cryptoxanthin and said
it would be incorrect to apply the same conversion factor to naturally
occurring, as compared to synthetically derived, [beta]-carotene.
    (Response) We agree there is a difference in biological activity
between synthetic and naturally derived [beta]-carotene. Information
presented in Table 2 of the proposed rule (79 FR 11879 at 11931)
inadvertently omitted a conversion for RAE from [beta]-carotene from
supplements. The table in Sec.  101.9(c)(8)(iv) of the final rule
includes the conversions for mcg RAE to mcg supplemental [beta]-
carotene:

1 retinol activity equivalent (mcg RAE) = 1 mcg retinol
    2 mcg supplemental [beta]-carotene
    12 mcg of dietary [beta]-carotene
    24 mcg of other dietary provitamin A carotenoids
    ([alpha]-carotene or [beta]-cryptoxanthin)

    (Comment 432) The proposed rule, at Sec.  101.9(c)(8)(iv), would
change the units of measure for vitamin E by replacing ``IU'' with
``mg,'' representing mg [alpha]-tocopherol. The preamble to the
proposed rule (79 FR 11879 at 11932) explained that the new measure of
vitamin E activity would account for the difference in activity between
naturally occurring and synthetic vitamin E.
    Several comments supported the definition of vitamin E as mg
[alpha]-tocopherol. However, other comments disagreed with mg [alpha]-
tocopherol and recommended that we include other forms, in addition to
[alpha]-tocopherol, in the definition of vitamin E. The comments said
that other forms of vitamin E have biological activity and that some
forms are linked to cancer, stroke, and neurodegeneration. One comment
cited several studies to support the assertion that other forms of
vitamin E have bioactivities that are important to disease prevention
and/or therapy (Refs. 240-245). One comment disagreed with the use of
mg [alpha]-tocopherol for vitamin E and suggested we include different
forms of vitamin E and relative amounts so that the vitamin E
declaration is not misleading.
    (Response) We decline to include other forms in the definition of
vitamin E. As we noted in the preamble to the proposed rule (79 FR
11879 at 11926), RDIs for vitamins and minerals are based on the DRIs
set by the IOM that reflect the most current science regarding nutrient
requirements. The RDA for vitamin E was established for mg of [alpha]-
tocopherol because [alpha]-tocopherol is the only form of vitamin E
that is maintained in blood and has biological activity (79 FR 11879 at
11933). We acknowledge the studies submitted to support the assertion
that other forms of vitamin E, such as gamma-tocopherol, have
biological activity that may be pertinent to disease prevention and/or
therapy. However, these individual studies measured outcomes other than
induced human vitamin E deficiency assessed by the correlation between
red blood cell lysis and plasma [alpha]-tocopherol on which the RDA was
based (Ref. 246). Jiang et al. 2003 studied gamma tocopherol and its
metabolite on markers of inflammation in rats (Ref. 241). Mahabir et
al. 2008 studied the associations between 4 tocopherols ([alpha]-,
[beta]-, c-, and d-tocopherol) in human diets and lung cancer risk
(Ref. 243). The review article by Wolf discussed the biochemical
mechanism by which [alpha]-tocopherol influences gamma-tocopherol (Ref.
245). Christen et al. 1997 studied the effects of gamma-tocopherol on
lipid peroxidation in vitro (Ref. 240). Jiang et al. 2008 studied the
effect of different forms of vitamin E and their metabolites on enzyme
reactions involved in the inflammation pathway (cyclooxygenase-
catalyzed reactions) in vitro (Ref. 242). The review article by Sen et
al. 2007 discussed tocotrienols and their biological functions. While
these animal studies and review articles may suggest biological
activity of other forms of vitamin E, outcomes in humans are lacking,
thus a totality of evidence for a role of other forms of vitamin E in
human health is lacking (Ref. 246). We consider the totality of
evidence, such as what is presented in consensus reports like those
issued by the IOM, rather than individual studies, to establish the
RDIs. Therefore, based on the information provided in the comment, we
do not have a basis to include other forms of vitamin E in our
definition.
    We note, however, that other forms of vitamin E can be listed in
the ingredient statement for foods.
    (Comment 433) The proposed rule, at Sec.  101.9(g)(10), would
require manufacturers to verify the declared amount of both all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol in the finished
food product. The preamble to the proposed rule (79 FR 11879 at 11933)
explained that the RDA for vitamin E is 15 mg/day of [alpha]-tocopherol
and that [alpha]-tocopherol is the only form of vitamin E that is
maintained in blood and has biological activity. The preamble to the
proposed rule also explained that there are eight stereoisomers of
[alpha]-tocopherol (RRR, RSR, RRS, RSS, SRR, SSR, SRS, SSS) and that
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 (e.g., all rac-[alpha]-
tocopherol acetate). Four stereoisomers (SRR, SSR, SRS, and SSS) are
not maintained in human plasma or tissues, so we proposed to limit the
new RDA for vitamin E to the four 2R stereoisomeric forms (RRR, RSR,
RRS and RSS) of [alpha]-tocopherol. We stated that these four forms of
[alpha]-tocopherol are found in nonfortified and fortified

conventional foods and dietary supplements and that 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 (id.).
However, because AOAC methods cannot individually measure the naturally
occurring and synthetic forms of vitamin E, it is necessary to know the
amount of both RRR-[alpha]-tocopherol and all rac-[alpha]-tocopherol in
a food product to calculate vitamin E activity for declaration as mg
[alpha]-tocopherol.
    One comment suggested that it is more practical for manufacturers
of vitamin E esters to ascertain the RRR, RSR, RRS and RSS content in
their ingredients and to disclose this information to finished food
manufacturers for use in calculating the declared amount of vitamin E,
instead of requiring finished food manufacturer to test the finished
product to verify the amounts of various forms of vitamin E, especially
since valid methods for many food matrices may not be available. The
comment was concerned that, even if they can be identified, analytical
methods may not be valid for a wide variety of food matrices and may be
prohibitively expensive.
    Another comment asked that we affirmatively state that, if
appropriate new methods become available to distinguish natural and
synthetic vitamin E, manufacturers must declare the amount of vitamin E
by appropriate and reliable analytical testing.
    Another comment disagreed with narrowing the definition of vitamin
E to four stereoisomers and said it is burdensome to confirm which
stereoisomer is present in synthetic vitamin E additives compared to
simply confirming that the additive is, indeed, vitamin E.
    (Response) We decline to revise the rule as suggested by the
comments.
    However, on our own initiative, we are correcting an inadvertent
error that we made in the proposed rule. The proposed rule used the
term ``all rac-[alpha]-tocopherol acetate'' when referring to the
synthetic form of vitamin E in fortified foods or dietary supplements
because esters of synthetic vitamin E are commonly used in fortified
foods and dietary supplements. However, the correct term for synthetic
vitamin E is all rac-[alpha]-tocopherol, just as the term for naturally
occurring vitamin is RRR-[alpha]-tocopherol. Esters of synthetic
vitamin E are not limited only to ``all rac-[alpha]-tocopherol
acetate'' and also include ``all rac-[alpha]-tocopheryl succinate.'' We
note that the term `all rac-[alpha]-tocopherol' is the correct term to
refer to the synthetic form of vitamin E.
    With respect to analytical testing, we decline to speculate on the
methods that manufacturers may deem practical to verify the declared
amount of both RRR-[alpha]-tocopherol and all rac-[alpha]-tocopherol in
finished food products. We acknowledge that it is a new requirement to
verify the amount of both RRR-[alpha]-tocopherol in the finished food
and all rac-[alpha]-tocopherol added to the food in finished food
products when a mixture of both are present in a food. However, without
AOAC methods to individually measure these two forms of vitamin E and
the inability to determine the amount of RRR-[alpha]-tocopherol in a
food by subtracting the amount of all rac-[alpha]-tocopherol from the
total amount declared, we need to rely on recordkeeping to verify the
amount of vitamin E in a product.
    As for the comment's statement that analytical methods may be
prohibitively expensive, the practicality or feasibility of using new
analytical methods can depend on a variety of factors. For example, a
method that uses equipment or technology that is readily available may
be less costly compared to a method that uses proprietary equipment or
technology. The number of facilities that can use a new analytical
method may influence cost. For example, if a large number of facilities
are able to use a new analytical method, then testing costs between
facilities may become competitive; in contrast, if there are few
facilities that can use the analytical method, then testing costs may
be less sensitive to competition. Consequently, because we do not know
what new analytical methods may exist in the future or the market for
those new methods, we cannot say whether those methods will be
prohibitively expensive.
    We also decline to revise the rule to affirmatively state that
manufacturers declare the amounts of vitamin E by appropriate and
reliable analytical testing, if appropriate new methods become
available. The comment did not explain how manufacturers would be able
to determine whether a new method was ``appropriate'' or ``available''
or how differences in opinion as to whether a particular method is
``appropriate'' or ``available'' might be resolved. Current AOAC
methods cannot individually measure naturally occurring vitamin E (RRR-
[alpha]-tocopherol) and synthetic vitamin E (all rac-[alpha]-tocopherol
and its esters) in food products. Nevertheless, we will continue to
monitor developments regarding methods to distinguish natural and
synthetic vitamin E.
    As for the comment objecting to narrowing the definition of vitamin
E to four stereoisomers because it is burdensome to confirm which
stereoisomer is present in synthetic vitamin E additives, we point out
that providing information that a vitamin E additive is only present in
a product (rather than confirming the stereoisomers present in the
synthetic vitamin E additive) would provide an inaccurate estimation of
the vitamin E activity in the body. We reiterate that the RDI for
vitamin E is based on the RDA for vitamin E which is limited to the
four 2R stereoisomeric forms (RRR, RSR, RRS, and RSS) of [alpha]-
tocopherol (79 FR 11879 at 11926). Because synthetic vitamin E, also
referred to as all rac-[alpha]-tocopherol, contains both 2R- and 2S-
stereoisomers of [alpha]-tocopherol and has one-half the activity of
the RRR-[alpha]-tocopherol naturally found in foods or the other 2R
stereoisomers of [alpha]-tocopherol, it is necessary to determine the
stereoisomers present in a food to determine vitamin E activity.
    (Comment 434) One comment noted that the proposed rule did not
mention other esters of both natural (d-[alpha]-tocopheryl acetate) and
synthetic forms of vitamin E ([alpha]-tocopheryl succinate) and said we
should revise the rule to include these forms.
    (Response) We agree that the ester forms of natural and synthetic
vitamin E are considered as [alpha]-tocopherol forms of vitamin E. The
RDA for [alpha]-tocopherol is limited to RRR-[alpha]-tocopherol
(historically and incorrectly labeled d-[alpha]-tocopherol) the only
form of [alpha]-tocopherol that occurs naturally in foods, and the
other 2R-stereoisomeric forms of [alpha]-tocopherol (RSR-, RRS-, and
RSS-[alpha]-tocopherol) that are synthesized chemically and found in
fortified foods and supplements. Vitamin E compounds include RRR-
[alpha]-tocopherol (also referred to as d-[alpha]-tocopherol or
natural) and its esters (i.e. RRR-[alpha] -tocopheryl acetate, RRR-
[alpha] -tocopheryl succinate) and all rac-[alpha]-tocopherol (also
referred to as dl-[alpha]-tocopherol) and its esters (i.e., all rac-
[alpha]-tocopheryl acetate, all rac-[alpha]-tocopheryol succinate)
(Ref. 247). We note that all of these vitamin E compounds may be
present in fortified foods and multivitamins. We have revised the rule
to include the ester forms of natural and synthetic vitamin E.
    (Comment 435) Another comment requested we provide a conversion in
the final rule stating 1 mg [alpha]-tocopherol (label claim) = 1 mg
RRR-[alpha]-tocopherol; 1 mg [alpha]-tocopherol (label claim) = 2 mg
all rac-[alpha]-tocopherol.
    (Response) We agree with the comment. The final rule provides this

conversion as a footnote in the table in Sec.  101.9(c)(8)(iv): 1 mg
[alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR-
[alpha]-tocopherol = 2 mg all rac- [alpha]-tocopherol.
    (Comment 436) Some comments objected to changing the units of
measure for vitamin E. Several comments stated that there are no AOAC
international official methods to distinguish between different forms
of vitamin E in foods and supplements. One comment objected the change
to mg [alpha]-tocopherol and said there is a lack of scientifically
validated methods capable of individually measuring all rac-[alpha]-
tocopherol acetate and RRR-[alpha]-tocopherol.
    Another comment said that it is not possible to measure total
vitamin E by subtracting all rac-[alpha]-tocopherol acetate from total
vitamin E to determine RRR-[alpha]-tocopherol.
    (Response) We agree that current AOAC methods cannot individually
measure naturally occurring vitamin E (RRR-[alpha]-tocopherol) and all
rac-[alpha]-tocopherol in foods. We also agree that it is not possible
to measure total vitamin E by subtracting all rac-[alpha]-tocopherol
from total vitamin E to determine RRR-[alpha]-tocopherol. For this
reason, the final rule, at Sec.  101.9(g)(10)(vi), requires
manufacturers to make and keep written records of the amount of all
rac- [alpha]-tocopherol added to the food and RRR-[alpha]-tocopherol in
the finished food.
    We disagree with the comment objecting to changing the unit of
measure to mg [alpha]-tocopherol because there is a lack of
scientifically validated methods capable of individually measuring all
rac-[alpha]-tocopherol and RRR-[alpha]-tocopherol. We consider the DRIs
that reflect the most current science regarding nutrient requirements
as the basis for establishing RDIs and, therefore, the declaration of
vitamin E as mg [alpha]-tocopherol. The choice of unit of measure for
vitamin E is not based on the availability of scientifically validated
methods capable of individually measuring all rac-[alpha]-tocopherol
and RRR-[alpha]-tocopherol.
5. Niacin
    (Comment 437) Our preexisting regulations, at Sec.
101.9(c)(8)(iv), state that the RDI for niacin is 20 mg. The proposed
rule would amend Sec.  101.9(c)(8)(iv), in relevant part, by changing
the unit of measure from ``mg'' to ``milligrams NE'' where ``NE'' would
stand for ``niacin equivalents,'' and a footnote to proposed Sec.
101.9(c)(8)(iv) would explain that 1 milligram NE is equal to 1
milligram niacin or also equal to 60 milligrams of tryptophan. The
preamble to the proposed rule discussed updating the RDIs for various
nutrients (including niacin) and compared the current RDI of 20 mg
against the proposed RDI of 16 mg NE (79 FR 11879 at 11927, 11931).
    Several comments supported changing ``mg'' niacin to mg niacin
equivalents (NE). The comments said the change would be consistent with
the IOM's use of RDAs as the basis for establishing reference values
for purposes of food labeling. Another comment referred to the footnote
in proposed Sec.  101.9(c)(8)(iv) and noted that ``milligrams NE'' is
different from the existing regulation's use of ``milligrams.'' The
comment said that it assumed that compliance would be determined by
testing the product using AOAC methods for both niacin and tryptophan
and that this, if correct, would increase the burden on manufacturers
because it will necessitate additional testing.
    In contrast, other comments would have us continue to use
milligrams as the unit of measure for niacin.
    (Response) The RDA for niacin is expressed as niacin equivalents
(NE) because the body's niacin requirement is met not only by preformed
niacin (nicotinamide, nicotinic acid, and its derivatives) in the diet,
but also from conversion from dietary protein containing tryptophan
(Ref. 248).
    We agree with the comment that compliance with a voluntary
declaration of niacin would be determined by analysis, using AOAC
methods, for both niacin and tryptophan, or by reference to existing
databases for both nutrients. Niacin equivalents would be calculated
using the following conversion: NE (niacin equivalents): 1 mg NE = 1 mg
preformed niacin = 60 milligrams of tryptophan. While the unit of
measurement for the RDI for niacin is listed as mg NE in Sec.
101.9(c)(8)(iv), only the amount ``mg'' will continue to be declared on
nutrition and supplement facts labeling.
    (Comment 438) One comment asked how compliance will be determined
and asked us to clarify whether a declaration of niacin content will be
required for products that contain no actual niacin. The comment would
revise the rule to include a provision specifying that products
containing more than 19 mg of tryptophan (corresponding to 0.32 mg of
niacin or 2 percent of the RDI) must declare niacin even if there is no
actual niacin present or else the manufacturers of such products might
not notice the revised requirements for niacin declaration. Another
comment noted that, for many protein-containing products for which
there is presently no information on tryptophan required, manufacturers
would be required to determine niacin and tryptophan content, either
through analytic testing or existing databases.
    (Response) The declaration of niacin is voluntary unless it is
added as a nutrient supplement to the food or if the label makes a
nutrition claim about it. Compliance may be determined by measuring
niacin and tryptophan separately. The unit of measure (mg NE) includes
both preformed niacin (from nicotinic acid and nicotinamide in the diet
or niacin) and niacin resulting from the conversion of tryptophan (Ref.
249), and AOAC methods exist for both niacin and tryptophan. Thus, a
declaration of niacin content requires products to include
contributions from preformed niacin as well as tryptophan, including
those that may not contain preformed niacin.
    As for the comment's statement that manufacturers may not notice
the revised requirements for niacin declaration, we decline to revise
the rule as suggested by the comment. We note that Sec.
101.3(e)(4)(ii) (regarding identity labeling of food in packaged form)
states, in relevant part, that a measurable amount of an essential
nutrient in a food shall be considered to be 2 percent or more of the
Reference Daily Intake (RDI) of any vitamin or mineral listed under
Sec.  101.9(c)(8)(iv) per reference amount customarily consumed. We
recognize that manufacturers may be unaware of the requirement for
niacin declaration in mg and plan to engage in education and outreach
explaining the revised changes to units of measurement for vitamins and
minerals.
    As for the comment that manufacturers would be required to
determine niacin and tryptophan content, either through analytic
testing or existing databases, we note we have not stated how a company
should determine the nutrient content of their product for labeling
purposes (Ref. 122). Regardless of its source, a company is responsible
for the accuracy and the compliance of the information presented on the
label. Use of a database that we have accepted may give manufacturers
some assurance in that we have stated that we will work with industry
to resolve any compliance problems that might arise for food labeled on
the basis of a database that we have accepted. A manual entitled ``FDA
Nutrition Labeling Manual: A Guide for Developing and Using Databases''
is available online.
    (Comment 439) One comment pointed out that the use of mg NE may not
accurately reflect niacin contribution in

foods because the conversion of tryptophan to niacin is highly variable
among individuals and because the body uses tryptophan primarily for
its role in protein synthesis instead of niacin production. The comment
said that using mg NE as the unit of measure could represent an over-
estimate of niacin intake in the diet. Another comment was concerned
there could be an extra step in food labeling and another potential
source of error.
    (Response) We disagree that using mg NE may lead to overestimates
of niacin intake from foods. We acknowledge that the conversion of
tryptophan to niacin may vary among individuals and that tryptophan has
a role in protein synthesis. The conversion factor of 1 mg NE = 60 mg
tryptophan is the mean of a wide range of individual values from human
studies that measured the conversion of tryptophan to urinary niacin
metabolites (Ref. 248).
    We acknowledge the concern that using mg NE involves an added step
of measuring tryptophan, but note that tryptophan is converted to
niacin by the body and using mg NE provides a more accurate estimation
of available niacin in the body compared to mg of niacin.
    (Comment 440) The proposed rule, at Sec.  101.9(c)(8)(iv), would
include a footnote stating that ``NE'' means niacin equivalents and
that ``1 milligram niacin = 60 milligrams of tryptophan.'' One comment
suggested that, for additional clarity and consistency, we should
revise footnote 2 to say ``NE = Niacin equivalents, 1 NE = 1 milligram
niacin = 60 milligrams of tryptophan.''
    (Response) We agree with the comment and have revised the footnote
for NE as follows: NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60
milligrams tryptophan.''

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

    In the preamble to the proposed rule (79 FR 11879 at 11933), we
explained that our 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)). As another example,
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 fat, calories from saturated fat,
saturated fat, polyunsaturated fat, monounsaturated fat and cholesterol
on the Nutrition Facts label (Sec.  101.9(j)(5)(i)).
    The preamble to the proposed rule (79 FR 11879 at 11933) also
mentioned that our regulations do not include DRVs or RDIs for
nutrients, generally, for infants, children under 4 years of age, or
pregnant and lactating women, but there are requirements for a DRV for
protein for children 4 or more years of age and RDIs 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)).
1. Age Range for Infants and Young Children
    Our preexisting regulations, at Sec.  101.9(j)(5), 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. The preamble to the
proposed rule (79 FR 11879 at 11933 through 11934) stated that comments
to our 2007 ANPRM recommended changing the 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 the preamble to the proposed rule (79 FR 11879
at 11933 through 11934), we discussed why we considered it appropriate
to adopt the same age categories as those used in the IOM DRIs for
infants and children. In brief, we said:
     Our proposed DVs are based on these age-specific DRIs;
     Infants are transitioning to eating solid foods by 7
through 12 months, and there are a number of foods in the marketplace
identified for this age group;
     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);
     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); and
     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.
    Therefore, we proposed 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 proposed 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.
    (Comment 441) Several comments supported providing nutrition
information for children less than 4 years because, according to the
comments, these subgroups have different nutritional needs. Another
comment recommended mandatory nutrition labeling for children less than
12 months and children 1 through 3 years. One comment said that we
should continue to allow labeling information on foods for infants less
than 7 months, such as infant cereals, or, at a minimum, allow such
labeling to remain voluntary.
    (Response) We agree, in part, with the comments that recommended
mandatory nutrition labeling for infants less than 12 months. We
decline to revise the age range for infants to infants less than 12
months because using that age range would leave a 1 month gap as the
age for children 1 through 3 years represents 13 through 48 months. We
also agree that nutrition labeling on foods represented or purported to
be for infants less than 7 months old such as infant cereals should
continue to be mandatory. We proposed the age category for labeling of
infants 7 through 12 months to be consistent with the age ranges used
in the IOM's age-specific DRI recommendations as well as current
breastfeeding recommendations for the first 6 months of life (79 FR
11933). Optimally, infants should begin eating complementary foods at
around 6 months of age (AAP Section on Breastfeeding 2012, WHO
Complementary feeding 2010); however, some infants are being introduced
to foods and beverages before then (siega-Riz JADA 2010). To ensure
that nutrition labeling includes products for infants and allow for
flexibility in timing of complementary food, we have amended Sec.
101.9(j)(5)(i) and (ii) to refer only to ``infants'' as infants through
12 months of age rather than infants less than 12 months (as suggested
by the comment) or ``infants 7 through 12 months'' of age as we had
proposed. (We have made similar edits in Sec.  101.9(c), (c)(7),
(c)(8), (d)(1), (e), and (f) to refer to ``infants through 12 months of
age.'')

    We note that, while nutrition labeling is mandatory for food for
children less than 4 years, we are not establishing DVs for infants
less than 7 months of age. Therefore, nutrition information on foods
purported for infants less than 7 months would not reflect DVs for that
age group.
    (Comment 442) One comment said that labeling of foods for infants 7
through 12 months and children 1 through 3 years is overdue and
important. The comment said, however, that separate labeling for these
two ages is not necessary and could be confusing, so the comment
recommended that we use a population approach to set single values for
7 months through 3 years.
    Another comment noted that the proposed new age range to set
labeling requirements for these foods (infants 7 through 12 months and
children 1 through 3 years of age) did not take into account the
definition of ``young children'' given in different Codex standards
(e.g., 074-1981 Rev. 1-2006) whereby ``young children'' are ``persons
from the age of more than 12 months up to the age of 3 years (36
months).''
    (Response) We disagree with the comment suggesting an age range of
7 months through 3 years of age. Providing one label for infants and
children 7 months through 3 years of age is inappropriate because
growth and nutrient needs differ for infants through 12 months of age
and children 1 through 3 years of age (beginning at the start of the
13th month through the end of 48th month of age). These differences in
growth and development between infants and young children are reflected
in the age categories established by the IOM (79 FR 11879 at 11933).
    As for the comment noting that we did not take into account the
definition of ``young children'' used in certain Codex texts, we note
that our age range of children 1 through 3 years of age includes
``persons from the age of more than 12 months up to the age of 36
months.'' We also note that our age range aligns with the age specific
category used in the IOM's DRI recommendations for the purposes of
establishing DRVs and RDIs for this subpopulation. Our purpose of
establishing a DRV or RDI for use in nutrition labeling is distinct
from a purpose related to defining the age range when infants and young
children are fed processed cereal-based complementary foods (CODEX STAN
074-1981, REV.1-2006). Furthermore, while certain Codex standards such
as the Standard for Processed Cereal-based Foods for infants and young
children (CODEX STAN 074-1981, REV.1-2006) provide minimum and maximum
levels for the composition of processed cereal-based complementary
foods, we note that the Codex Guidelines on Nutrition Labelling (CAC/GL
2-1985) (Ref. 121) do not provide Nutrient Reference Value--
Requirements that are comparable to our proposed DRVs and RDIs for
children 1 through 3 years. (Comment 443) Some comments asked that we
require the declaration of cannabinoid content, nutritional values,
and/or health risks pertaining to the consumption of
tetrahydrocannabinol (THC) and/or marijuana edibles for all consumers,
in particular, children under the age of 4 years as well as pregnant
and lactating women.
    (Response) We decline to revise the rule as suggested by the
comment. We note that section 403(q)(2)(A) of the FD&C Act authorizes
the inclusion of nutrients on the label or labeling of food for
purposes of providing ``information regarding the nutritional value of
such food that will assist consumers in maintaining healthy dietary
practices.'' General labeling requirements of products containing THC
and/or marijuana edibles is outside the scope of this rule. Therefore,
we are making no changes in response to this comment.
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. In the preamble to
the proposed rule (79 FR 11879 at 11934), we tentatively concluded
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 and, therefore,
their mandatory declaration can assist in maintaining healthy dietary
practices. We proposed to remove Sec.  101.9(j)(5)(i) and revise and
redesignate current Sec.  101.9(j)(5)(ii) as Sec.  101.9(j)(5)(i).
    Similarly, 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. In the
preamble to the proposed rule (79 FR 11879 at 11934), we tentatively
concluded 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. Thus, we
proposed 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 for foods
represented or purported to be specifically for infants 7 through 12
months of age, children 1 through 3 years of age, and pregnant and
lactating women, and permit the declaration of calories from saturated
fat such that the declaration of these nutrients on foods for these
populations would be subject to the same requirements applicable to
foods for the general population.
    (Comment 444) Several comments supported the declaration of
saturated fat and cholesterol on labeling for infants and children 1
through 3 years old and agreed such labeling will help maintain
healthful dietary practices. In response to our request for information
on whether consumers may be confused by these changes, one comment said
that its products have been labeled for children under 2 years as well
as for children less than 4 years of age on the market for many years.
The comment noted that these dual label formats include the declaration
of both saturated fat and cholesterol and the company has received no
comments or concerns about the inclusion of this information on its
labels from either consumers or health care professionals. The comment
said that declaring saturated fat and cholesterol in addition to trans
fat on infant foods will be more helpful in

food selection than having trans fat alone. The comment said declaring
saturated fat, cholesterol, and trans fat will provide more information
on the fat composition of foods and their relationship to chronic
disease risk. The comment also noted that some children as young as 12
months, with a family history of obesity, dyslipidemia, or CVD, may
benefit from a diet lower in saturated fat and that having saturated
fat on food labels can assist families in choosing foods that are lower
in saturated fat while maintaining total fat intakes.
    Another comment said we should not finalize the rule until we had
conducted appropriate research, including consumer testing, to better
understand the impacts of declaring saturated fat and cholesterol on
the labels of products represented or purported to be specifically for
infants and children 1 through 3 years of age and to determine if an
explanatory footnote would assist in improving consumer understanding
when accompanying any relative declaration. The comment also noted that
relevant empirical research is not available to determine whether the
declaration of saturated fat and cholesterol will result in restricted
intakes for infants and children ages 1 through 3 years old. One
comment would revise the rule to include a voluntary footnote stating
that ``total fat should not be limited in the diets of children less
than 2 years unless directed by a physician'' or similar wording to
provide dietary guidance to parents and other caregivers to help assure
total fat is not restricted in the diet of young children.
    (Response) We acknowledge that products dual labeled for children
under 2 and children less than 4 years of age include the declaration
of both saturated fat and cholesterol. We agree that declaration of
saturated fat and cholesterol provides more nutrition information and
can help consumers make informed choices and maintain a healthy diet,
and the final rule requires the declaration of saturated fat and
cholesterol on Nutrition Facts labeling for infants and children 1
through 3 years of age.
    As for the comment regarding consumer testing, we disagree that
consumer testing is necessary before we can require the declaration of
saturated fat and cholesterol on Nutrition Facts labels for infants and
children 1 through 3 years of age. Section 403(q) of the FD&C Act lists
total fat, saturated fat, and cholesterol as nutrients required on
nutrition labeling. These nutrients are essential for growth and
development, thus their mandatory declaration can assist consumers in
maintaining healthy dietary practices (79 FR 11879 at 11934). We
considered the Integrated Guidelines for Cardiovascular Health and Risk
Reduction in Children and Adolescents which suggest a diet with
saturated fat less than 10 percent of calories and cholesterol intake
less than 300 mg/day can safely and effectively reduce the levels of
total and LDL cholesterol in healthy children (Ref. 250). This type of
diet may have similar effects when started in infancy and sustained
throughout childhood into adolescence (Ref. 250).
    We acknowledge, in general, that total fat should not be limited in
the diets of young children less than 2 years of age unless directed by
a health professional. In response to the comment noting that research
is unavailable on whether declaration of saturated fat and cholesterol
will result in restricted intakes for infants and children, we intend
to monitor fat and cholesterol intakes in these age groups and will
consider whether to revisit our requirements for this labeling, as
appropriate.
    We also decline to include a voluntary footnote. We intend to
monitor fat intakes and educate consumers on changes to the labeling of
foods for infants through 12 months of age and children 1 through 3
years of age.
    b. Percent DV declaration. In the preamble to the proposed rule (79
FR 11879 at 11935), we explained that, under our preexisting
regulations, 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 vitamin A, vitamin C, iron, and calcium. We tentatively
concluded 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 through 12 months, for children 1 through 3 years of age, and
for pregnant and lactating women (except for a % DV for protein for
pregnant and lactating women), and this change would be reflected in
redesignated Sec.  101.9(j)(5)(i).
    (Comment 445) One comment would retain a requirement for the
mandatory declaration of percent DV for protein on infant foods.
    In contrast, another comment would not require the mandatory
declaration of the percent DV for protein on labels of foods for
children aged 1 through 3 years. The comment cited dietary intake data
suggesting that protein intakes are above 40 grams per day and from
high quality sources. Another comment recommended allowing for the use
of the PDCAAS for determining the percent DV for protein for all
population groups, including infants. The comment asked us to clarify
the acceptability of PDCAAS for determining protein quality for foods
for infants and specify the specific amino acid pattern that should be
used (i.e., IOM pattern) and to reference the pattern by Table number.
    (Response) The final rule requires the mandatory declaration of
percent DV for protein on foods for infants though 12 months of age and
children 1 through 3 years of age. While the evidence suggests that
protein intake is adequate and of high quality, 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. Calculating the percent DV for protein incorporates a
measure of protein quality. Thus, the percent DV declaration is a
useful tool to indicate protein quality to the consumer. Because of the
importance of adequate high quality protein in the diets of infants and
young children, we conclude that the percent DV declaration for protein
for infants though 12 months of age and children 1 through 3 years of
age should remain mandatory.
    We disagree with the comment asking that we allow for the use of
the PDCAAS to determine protein quality for infants. The PDCAAS allows
evaluation of food protein quality based on the needs of humans as it
measures the quality of a protein based on the amino acid requirements
(adjusted for digestibility) of a 2- to 5-year-old child (considered
the most nutritionally demanding age group), not infants (Ref. 251).
Protein quality is important during infancy for growth and development.
We established the protein efficiency ratio (PER) as the method of
determining protein quality (see 79 FR 7934 at 8022) for infants based
on recommendations from the 1991 WHO Protein Quality report. A protein
source may contain the necessary amino acids, but they may be in a form
that an infant cannot digest and absorb. The PER method, unlike
chemical measures of protein composition, provides an estimate of the
bioavailability or amount absorbed, of the protein.
    (Comment 446) One comment said that, if the percent DV for protein
remains mandatory, we should provide

an exemption from the mandatory declaration of percent DV for protein
for foods intended for infants and children aged 1 through 3 years that
declare less than 1 gram of protein per serving, such as fruits,
because these foods contain an insignificant amount of protein and are
not expected to contribute meaningfully to protein intake. The comment
also would revise the rule to allow the optional declaration of ``0%
DV'' instead of the phrase ``not a significant source of protein'' on
infant foods with a protein quality of less than 40 percent of casein
as measured by PER or less than 40 percent by PDCAAS or other
comparable method. The comment explained that these options will help
save label space, especially on small packages, while still providing
meaningful information on protein quantity relative to the DV.
    (Response) We decline to revise the rule as suggested by the
comment. While we recognize that the protein quantity of some foods,
such as fruits, may be small, we consider the mandatory declaration of
percent DV to provide important information on protein quality to the
consumer. In establishing mandatory declaration of percent DV for
protein on foods intended for infants through 12 months of age and
children aged 1 through 3 years and associated statements of ``less
than 1 g of protein per serving'' or ``not a significant source of
protein,'' we considered that: (1) 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; and
(2) calculating the percent DV for protein incorporates a measure of
protein quality. Thus, the percent DV declaration is a useful tool to
indicate protein quality to the consumer.
    While label space on small packages may be a concern, we decline to
make the change requested by the comment that would allow the optional
declaration of ``0% DV'' instead of the phrase ``not a significant
source of protein'' on infant foods with a protein quality of less than
40 percent of casein as measured by PER or less than 40 percent by
PDCAAS or other comparable method. As explained in part II.I and in our
response to comment 445, we concluded that the PDCAAS was the most
suitable pattern for use in the evaluation of dietary protein quality
for all age groups, except infants through 12 months of age. We
established the PER as the method of determining protein quality for
infants because infants cannot digest and absorb all forms of protein;
thus, PDCAAS or another comparable method that scores the amino acid
profile of the specific food protein after it has been digested is not
appropriate.
3. Declaration of Non-Statutory Nutrients Other Than Essential Vitamins
and Minerals
    In the preamble to the proposed rule (79 FR 11879 at 11935), we
stated that 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
declared voluntarily. Polyunsaturated fat, monounsaturated fat, soluble
fiber, insoluble fiber, and sugar alcohols can be declared voluntarily
on the label of foods represented or purported to be specifically for
children 2 through 4 years of age, and pregnant and lactating women.
    For foods represented or purported to be specifically for children
1 through 3 years of age and pregnant and lactating women, we
considered whether to propose the mandatory or voluntary declaration of
non-statutory nutrients. In the preamble to the proposed rule (79 FR
11879 at 11935), we said that 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)).
    a. Voluntary declaration of calories from saturated fat, and the
amount of polyunsaturated and monounsaturated fat. Our preexisting
regulations, at Sec.  101.9(j)(5)(i), state that foods, other than
infant formula, represented or purported to be specifically for infants
and children less than 2 years of age must bear nutrition labeling with
certain, specific exceptions. Among the exceptions, the label is not to
include polyunsaturated fat or monounsaturated fat.
    The proposed rule would remove the restriction regarding the
declaration of polyunsaturated fat and monounsaturated fat on foods
represented or purposed to be specifically for children less than 2
years of age. In the preamble to the proposed rule (79 FR 11879 at
11935 through 11936), we explained that, for infants 7 to 12 months,
there are no specific recommendations provided about calories from
saturated or polyunsaturated or monounsaturated fat. We also stated
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, that 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, and 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.
    (Comment 447) One comment argued the declaration of alpha linoleic
acid (ALA) on foods for infants and children 7 months to 3 years of age
should be considered for voluntary labeling using the AI as the basis
for a DRV. The comment noted that much of the evidence for a health
benefit of n-3 fatty acids derives from studies on infants, and
labeling of ALA is consistent with FDA's criteria of encouraging health
dietary practices. Another comment recommended that we examine NHANES
data for ALA consumption to determine whether there is a public health
risk from inadequate dietary intake.
    (Response) We decline to amend the rule to permit the voluntary
labeling of ALA on labels or labeling for foods intended for infants
though 12 months of age and children 1 through 3 years of age and to
use the AI for ALA to establish a DRV.
    We agree with promoting healthy dietary practices in this
subpopulation; however, well-established evidence for ALA and disease
risk reduction in adulthood and infancy is lacking (Ref. 29). As
discussed in part II.F.4, we decided that, because of the lack of well-
established evidence for a role of n-3 or n-6 polyunsaturated fatty
acids in chronic disease risk and the lack of a quantitative intake
recommendation, the declarations of [alpha]-linolenic acid as well as
other n-3 and n-6 polyunsaturated fatty acids are not necessary to
assist consumers to maintain healthy dietary practices. Because the
declaration of ALA is not permitted on labeling, a DRV for this
nutrient is unnecessary.
    We disagree with the analysis of NHANES data for ALA intake to
determine public health risk from inadequate dietary intake. An
analysis of dietary intake data alone does not meet our criteria of
public health significance. Moreover, an analysis of ALA intakes from
NHANES data cannot determine inadequacy of dietary intake

because an EAR has not been established for ALA. EARs, not AIs, are
used for assessing the statistical probability of adequacy or nutrient
intakes of groups of people (79 FR 11879 at 11885).
    (Comment 448) One comment noted that we proposed mandatory labeling
of the quantitative amount of some nutrients (trans fatty acids for
which there is no DRI) on foods for infants aged 7 through 12 months
and children aged 1 through 3 years. The comment said we should provide
for the voluntary declaration of docosahexaenoic acid (DHA) on these
foods to encourage healthy dietary practices.
    (Response) We decline to revise the rule as suggested by the
comment. Our regulations, at Sec.  101.9(c)(2)(ii), require the
declaration of trans fat on nutrition labeling for people of all ages
because the consumption of trans fats may affect their risk of CHD;
therefore, the presence or absence of trans fat in a food product is a
material fact that consumers need to know to make healthy choices and
allow them to reduce risk of CHD. Trans fat continues to be a nutrient
with public health significance because of its well-established role in
chronic disease through its effect on blood cholesterol levels (79 FR
11879 at 11896). However, DHA lacks well-established evidence for its
role in chronic disease as well as growth or neural development (IOM
Macro report). As discussed in part II.F, voluntary labeling of DHA is
not permitted because of the lack of well-established evidence for
DHA's role in chronic disease risk and lack of a quantitative intake
recommendation (79 FR 11879 at 11898).
    (Comment 449) One comment cited a 2011 IFIC survey suggesting that
45 percent of consumers were already eating foods containing n-3 fatty
acids to benefit cognitive development, especially in children and 39
percent were somewhat likely to begin eating n-3 fatty acids for this
health benefit in the next 12 months. The comment said that continued
allowance of ALA nutrient content claims, absent a voluntary
declaration of DHA, increases the likelihood that consumers may
purchase foods for a benefit that the food will not supply. The comment
also said that allowing polyunsaturated fat labeling of foods for
children younger than 2 years without allowance for labeling of
individual polyunsaturated fatty acids creates a scenario where
polyunsaturated fat values, inflated by ALA, may mislead consumers
actually seeking DHA.
    (Response) The comments did not provide, and we are not aware of,
data or information to support the claim that consumers seeking to
consume DHA would be misled by the voluntary declaration of
polyunsaturated fats or an ALA nutrient content claim on labeling for
children less than 2 years of age. Therefore, we are not making changes
in response to this comment.
    We acknowledge the 2011 IFIC survey conclusions suggesting that
consumers eating foods containing n-3 fatty acids are somewhat likely
to begin eating these foods to benefit cognitive development. We also
recognize that total polyunsaturated fats in foods include both n-6 and
n-3 polyunsaturated fatty acids and the n-3 polyunsaturated fatty acids
content may include ALA and DHA.
    However, we are unable to determine, based on the information
provided in the comment, if some consumers seeking to consume DHA may
be confused or misled by the declaration of total polyunsaturated fats
or the ALA nutrient content claim. Furthermore, we are unable to
determine if consumers understand that ALA may be converted to DHA.
Without knowledge of the conversion from ALA to DHA, consumers would
not be able to distinguish between the level and type of n-3 fatty
acids in the food.
    Thus, the final rule removes the restriction regarding the
declaration of calories from saturated fat, polyunsaturated fat, and
monounsaturated fat on foods represented or purposed to be specifically
for infants through 12 months of age and children 1 through 3 years of
age.
    b. Voluntary declaration of soluble fiber, insoluble fiber, and
sugar alcohols. In the preamble to the proposed rule (79 FR 11879 at
11936), we stated that, 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 beneficial physiological
endpoint (i.e., CHD, improved laxation, or dental caries). We also said
that 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. As a result, we did not propose 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.
    We did not receive comments on this topic, so no changes to the
rule are necessary.
    c. Mandatory declaration of trans fat. In the preamble to the
proposed rule (79 FR 11879 at 11936), we stated that trans fat must be
declared on the Nutrition Facts label and that our regulations do not
provide exceptions for foods represented or purported to be
specifically for infants, young children, or pregnant and lactating
women. We noted that cardiovascular disease is known to begin in
childhood (id.). Thus, we tentatively concluded 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, and we did not propose 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.
    Trans fat declaration is voluntary when the total fat content of a
food is less than 0.5 grams (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 grams, then the statement ``Not a significant
source of trans fat'' must be placed at the bottom of the table of
nutrient values.
    We did not receive comments on this topic and have finalized this
provision without change.
    d. Mandatory declaration of added sugars. Our preexisting
regulations do not provide for the declaration of added sugars on the
Nutrition Facts label, but the proposed rule would require the
mandatory declaration of added sugars on the Nutrition Facts label.
Additionally, in the Federal Register of July 27, 2015 (80 FR 44303),
we published a supplemental proposed rule that would, among other
things, establish a Daily Reference Value (DRV) of 10 percent of total
energy intake from added sugars and require the declaration of the
percent DV for added sugars on the label.
    (Comment 450) Several comments supported mandatory declaration of
added sugars. One comment stated that sugar is used as a means to
attract children, and this practice should be discouraged.
    Another comment opposed the mandatory labeling of added sugars for
infants and children aged 1 through 3 years and pregnant and lactating

women. The comment argued that scientific consensus is lacking for the
health effects of added sugars alone versus sugars as a whole and
recommended careful consideration of the totality of the scientific
evidence, as well as consideration of compliance and other technical
issues. The comment also noted that consumer testing is also highly
important prior to any determination relative to added sugars being
made.
    (Response) We disagree that added sugars should not be required on
the label for infants and children aged 1 through 3 years and pregnant
and lactating women. We discuss in part II.H.3 our rationale for
requiring the declaration of added sugars on the label for the general
population. We are also basing an added sugars declaration on labeling
for infants, children 1 through 3 years of age, pregnant women, and
lactating women on the need to provide consumers with information to
construct a healthy dietary pattern that meets the dietary
recommendations for added sugars.
    In response to the comment about the totality of evidence for the
health effects of added sugars, we discuss in part II.H.3 that rather
than basing a declaration of added sugars on an association with risk
of chronic disease, a health-related condition, or a physiological
endpoint, we are considering a declaration of added sugars in the
context of how it can assist consumers in maintaining healthy dietary
practices by providing information to help them limit consumption of
added sugars, and to consume a healthy dietary pattern. We have
established that there is public health significance of added sugars
through other evidence related to a healthy dietary pattern low in
sugar-sweetened foods and beverages that is associated with reduced
risk of CVD, through consumption data showing that Americans are
consuming too many calories from added sugars, through evidence showing
that it is difficult to meet nutrient needs within calorie limits if
one consumes too many added sugars, and through evidence showing that
increased intake of sugar-sweetened beverages is associated with
greater adiposity in children.
    The comment did not explain what compliance and other technical
issues merit further consideration. In response to the comment noting
the importance for consumer testing of a declaration of added sugars,
we have received several comments on this topic and discuss responses
in part II.H.3.g.
    While the declaration of added sugars is mandatory, we are not
establishing a DRV for added sugars for infants through 12 months.
Dietary recommendations for infants through 12 months suggest
introducing complementary foods such as infant cereal, vegetables,
fruits, meat, and other protein-rich foods modified to a texture
appropriate (e.g., strained, pureed, chopped, etc.) for the infant's
developmental readiness one at a time. A DRV for added sugars for
infants through 12 months is not necessary as the infant diet is
comprised primarily of breast milk and/or infant formula as well as
complementary foods. As the food introduced does not comprise the
majority of the infant diet, a DRV is not necessary to compare added
sugars in the context of a daily diet. Mandatory declaration of added
sugars for infants through 12 months of age can help consumers limit
the added sugars in the limited complementary foods that are being
introduced individually.
    (Comment 451) One comment would modify the definition of added
sugars to exclude ingredients that are inherent in the food or are
present for purposes other than sweetening the food and that this
modified definition should apply for adults and children between 7
months to 3 years of age, and pregnant and lactating women.
    (Response) We received many comments on the definition of added
sugars and, in part II.H.3.n, discuss ingredients that are inherent in
the food, such as naturally occurring sugars, and the intended purpose
of sweetening. The comment did not explain why a regulatory definition
for added sugars should be different for infants, children 1 through 3
years of age, and pregnant women, and lactating women, so we decline to
revise the rule as suggested by the comment.
    e. Voluntary declaration of fluoride. Our preexisting regulations
do not provide for the declaration of fluoride on the Nutrition Facts
label of any foods. The proposed rule would allow voluntary declaration
of fluoride on the labeling of foods for the general population, and we
also tentatively concluded 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. We stated, in the preamble to the proposed
rule (79 FR 11879 at 11937 through 11938), that evidence on dental
caries is lacking for infants 7 through 12 months of age, but we did
not 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.
    We did not receive comments on this topic and have finalized the
provision to permit the voluntary declaration of fluoride on foods
represented or purported to be specifically for infants through 12
months, children 1 through 3 years of age, pregnant women, and
lactating women.
4. Declaration of Essential Vitamins and Minerals
    Our preexisting regulations require the declaration of vitamin A,
vitamin C, calcium, and iron 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. In the preamble to the proposed rule (79 FR 11879 at 11937), we
explained that the AIs for essential vitamins and minerals (and RDAs
for iron and zinc) for infants 7 through 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. 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.
So, rather than determine public health significance for a nutrient
during infancy based on an AI for infants, 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 said, in
the preamble to the proposed rule (79 FR 11879 at 11937) that we would
use 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. We also
explained that, while NHANES data were collected in lactating women, we
did not include these data in our analysis because the sample size of
lactating women was small, and we could not reliably estimate mean
intake and status of this population (id.). However, we stated that 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, and we proposed 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 receive comment on this topic and are removing the
provision in Sec.  101.9(c)(8)(i) regarding 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.
    a. Mandatory declaration of calcium and iron. We did not propose
any changes to the mandatory declaration of calcium on foods for the
general population. In the preamble to the proposed rule (79 FR 11879
at 11937), we stated that 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 and that, for children 1 through 3 years of
age and pregnant and lactating women, the RDAs for calcium are based,
in part, on bone health.
    Our analysis of NHANES 2003-2006 data estimated that infants ages 7
to 12 months have usual calcium intakes above the AI and 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
(see 79 FR 11879 at 11937). We said, in the preamble to the proposed
rule (id.), that promoting the development of eating patterns that are
associated with adequate calcium intake later in life is important
given that calcium intakes are inadequate for the majority of the
population. 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. Consequently, we tentatively
concluded that calcium is a nutrient of public health significance for
children 1 through 3 years of age and for pregnant and lactating women
and that, because calcium is important for growth and development,
calcium is of public health significance for infants 7 through 12
months of age.
    With respect to iron, we stated, in the preamble to the proposed
rule (id.) that, while 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) and that our analysis of NHANES 2003-2006 data
estimated that about 18 percent of infants ages 7 through 12 months
have usual iron intakes below the EAR, based on intakes from
conventional foods only and 4 percent of infants ages 7 through 12
months have usual iron intakes below the EAR based on intakes from
conventional foods and supplements. 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. 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 (see 79 FR 11879 at 11937). We also stated that
inadequate iron intakes during pregnancy are 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) and that 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 (see 79 FR 11879 at
11937). Among pregnant women aged 12 to 49 years, 25 percent were iron
deficient and 13 percent had iron deficiency anemia. 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. Therefore, we tentatively
concluded that iron is a nutrient of public health significance for
lactating women as well.
    Thus, we proposed to amend Sec.  101.9(c)(8)(ii) to 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 did not receive any comments with respect to mandatory
declaration of calcium and iron for these populations, and so, other
than replacing ``infants 7 to 12 months'' with ``infants through 12
months,'' we have finalized the provisions without change.
    b. Mandatory declaration of vitamin D and potassium. We proposed to
require the declaration of vitamin D on foods for the general
population. With respect to infants, we stated, in the preamble to the
proposed rule (79 FR 11879 at 11938), that 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 and that 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) to maintain bone health for children 1 through 3 years of age
and pregnant women. Although serum 25(OH)D data were not available in
NHANES 2003-2006 for infants ages 7 to 12 months, we noted that our
analysis of NHANES 2003-2006 dietary data showed 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 (see 79 FR 11879 at 11938).
    Our analysis of NHANES 2003-2006 data showed that about 3 percent
of children 1 through 3 years of age had serum 25(OH)D levels below 40
nmol/L, while an analysis of NHANES 2005-2008 dietary data showed 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 (see 79 FR 11879 at 11938). 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 (id.). We
tentatively concluded 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 and 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 also proposed, at proposed Sec.  101.9(c)(8)(ii), to require the
declaration of potassium on foods for the general population. The AI
for the general population 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, but for
infants, the AI is based on average potassium intake from breast milk
and/or complementary foods (id.). Our analysis of NHANES 2003-2006
showed that 99 percent of infants ages 7 to 12 months have usual
potassium intakes above the AI and that only 7 percent of children 1
through 3 years of age and 4 percent of pregnant women 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. We acknowledged, in the preamble to the proposed rule (79
FR 11879 at 11938) that, as a result of a FDAMA notification for a
health claim about potassium, blood pressure, and stroke, 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, because potassium is important in the risk reduction of
these chronic diseases for children 2 years of age and older, we
tentatively concluded that potassium is of public health significance
to children 1 through 3 years of age, pregnant women, and lactating
women and that, 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, potassium is a nutrient of public health significance for
infants 7 through 12 months of age, children 1 through 3 years of age,
pregnant women, and lactating women. Thus, we proposed 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 and did not provide 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).
    We did not receive comments regarding potassium and these
subpopulations, so, other than replacing ``infants 7 to 12 months''
with ``infants through 12 months,'' we have finalized those provisions
without change.
    (Comment 452) One comment questioned the need for mandatory
disclosure of vitamin D on the Nutrition Facts panel. The comment cited
dietary intake data from food, beverages and supplements that suggests
at least 75 percent of children ages 1 through 3 years have adequate
intakes of vitamin D, not including sun exposure (Ref. 252). The
comment said that mandatory declaration of vitamin D is not of value
because relatively few foods have naturally occurring vitamin D,
limitations on vitamin D addition to foods already exist, and vitamin D
added to foods is already required on labeling. In addition, according
to the comment, labeling can not necessarily help consumers achieve
adequate intakes of vitamin D because it is not expected that all the
required vitamin D will be provided by foods or supplements. Another
comment noted that its products have many labels with very little label
space and that using this label space for a declaration of 0 percent DV
for vitamin D will limit its ability to provide other label information
including information on other nutrients present in the products at
significant levels.
    (Response) We disagree with comments arguing against the mandatory
declaration of vitamin D. We have determined that vitamin D is a
nutrient of public health significance (79 FR 11879 at 11921 and
11938). The comment cited data that assessed usual intakes using the AI
for vitamin D established in 1997 (Ref. 253). The IOM has since
established an EAR for vitamin D (Ref. 38). Our analysis of NHANES data
compared to the EAR showed 66 percent of children 1 through 3 years of
age had inadequate intake of vitamin D from foods and supplements (79
FR 11879 at 11938).
    We also disagree that mandatory declaration of vitamin D, including
the declaration of zero percent DV, is not of value because few foods
have naturally occurring vitamin D. As we discussed in the preamble to
the proposed rule (79 FR 11879 at 11938) and part II.L, we identified
vitamin D as a nutrient of public health significance for children 1
through 3 years of age based on the high prevalence of inadequate
intakes of vitamin D and its important role in bone development and
health (Ref. 198). Our analysis also shows that vitamin D intakes and
status remain inadequate in the general population (79 FR 11879 at
11922). While limited label space may present challenges, the
consideration for the mandatory declaration of vitamin D on the label
is whether it will help consumers maintain healthy dietary practices.
    While we acknowledge that some, but not all, vitamin D needs can be
met by the body's exposure to sunlight, we determined the mandatory
declaration of vitamin D based on the high prevalence of inadequate
intakes of vitamin D and its important role in bone development and
health (see part II.L). The mandatory declaration of vitamin D is
intended to help consumers maintain healthy dietary practices and make
healthy choices in context of a daily diet. The mandatory declaration
of vitamin D also provides information to consumers about what foods
are good sources of vitamin D and what foods do not contain vitamin D.
Therefore, we have finalized this provision without change.
    c. Voluntary declaration of vitamin A and vitamin C. We proposed to
no longer require the declaration of vitamin A and vitamin C on foods
for the general population. With respect to subpopulations, we noted,
in the preamble to the proposed rule (79 FR 11879 at 11939) that our
analysis of data from NHANES 2003-2006 showed that less than 2 percent
of children 1 through 3 years of age had usual vitamin A intakes below
the EAR from conventional foods or conventional foods plus dietary
supplements and that, 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. Furthermore, our analysis of data
from NHANES 2003-2006 showed that neither vitamin A nor vitamin C is
considered to have public health significance for children 1 through 3
years of age and pregnant women. Therefore, we tentatively concluded
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, but we proposed 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)).
    We did not receive comments regarding the voluntary declaration of
vitamins A and C for subpopulations, so, other than replacing ``infants
7 to 12 months'' with ``infants through 12 months,'' we have finalized
that provision without change.
    d. Voluntary declaration of other vitamins and minerals. For the
general population, we proposed 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)). In the preamble to the proposed rule (79 FR 11879 at
11939), we said that 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 concluded 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. Thus, 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, pregnant women, or 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.
    We did not receive comments regarding the voluntary declaration of
vitamin K, vitamin B6, vitamin B12, thiamin,
riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus,
iodine, magnesium, zinc, copper, manganese, chromium, molybdenum, and
chloride on foods represented or purported to be specifically for
infants through 12 months of age, children 1 through 3 years of age,
pregnant women, or lactating women. Therefore, other than replacing
``infants 7 to 12 months'' with ``infants through 12 months,'' we have
finalized these provisions without change.
    (Comment 453) One comment requested we reconsider mandatory
declaration of vitamin E on nutrition labeling for children 1 through 3
years of age. The comment said that about 63 percent of children 12 to
24 months and 37 percent of children 24 to 48 months have vitamin E
intakes below the EAR (Ref. 252). The comment also noted that
encouraging an adequate intake of vitamin E in the diets of young
children may encourage adequate consumption of foods with higher levels
of vegetable fat.
    (Response) We agree that vitamin E intakes are below the EAR and
disagree that mandatory declaration of vitamin E is needed. Our
analysis of NHANES data also has shown that intakes of children 1
through 3 years of age are below the EAR (79 FR 11879 at 11944).
However, low intakes of vitamin E have not been associated with
clinically relevant nutrient deficiency (Ref. 246). Therefore,
consistent with the factors for mandatory or voluntary declaration of
non-statutory nutrients (79 FR 11879 at 11889 and 11918, and part
II.D), we have determined that vitamin E is not a nutrient public
health significance for children 1 through 3 years of age and the
general population.
    The comment did not provide evidence to suggest that mandatory
declaration of vitamin E may encourage adequate intake and consumption
of foods with higher levels of vegetable fat, and we are not aware of
any evidence to support that proposition. Therefore, we are not making
changes in response to this comment.
    (Comment 454) One comment supported the voluntary declaration of
choline for pregnant and lactating women. The comment noted that
choline has a role in preventing neural tube defects in infants and
high intakes improve placental function and ease babies' response to
stress during pregnancy. Another comment suggested that some nutrients
should be considered for mandatory labeling, e.g., choline and selenium
as public health concerns. The comment also recommended that choline be
considered for mandatory labeling on foods for pregnant and lactating
women. The comment explained that mandatory labeling on foods in
general, should be driven by the interest to reduce the risk of chronic
diseases in adulthood, and should be revisited for foods for 7 months
through 3 years to emphasize the role of nutrients in development.
    (Response) We disagree that the declaration of choline and selenium
should be mandatory. As the comment suggested, we have considered the
relationship of nutrients and chronic disease risk, health-related
conditions, or a health-related physiological endpoints (i.e. growth
and development) in infants, children, and pregnant and lactating women
to determine its mandatory or voluntary declaration on labeling. Based
on our analysis of dietary intakes, we found no evidence of inadequate
intakes of choline and selenium in these subpopulations. We also found
no evidence for a substantial prevalence of chronic disease, health-
related condition, or nutrient deficiency with clinical significance
linked to choline and selenium in these subpopulations. Therefore,
consistent with the factors for mandatory or voluntary declaration of
these types of non-statutory nutrients (see part II.D), we have
determined that choline and selenium are not nutrients of public health
significance for infants through 12 months of age, children 1 through 3
years of age and pregnant and lactating women and have finalized the
provision regarding voluntary declaration.
5. DRVs and RDIs for Infants Through 12 Months of Age
    Our preexisting regulations do not include DRVs or RDIs for
nutrients for infants, except for an RDI of protein of 14 grams.
However, the proposed rule would establish a DRV or RDI for certain
nutrients, and we explained, in the case

of polyunsaturated fat, monounsaturated fat, insoluble fiber, soluble
fiber, added sugars, sugar alcohols, sodium, and fluoride, why we were
not proposing to establish a DRV.
    a. General comments.
    (Comment 455) One comment recommended considering dietary intake
data and public health need in addition to quantitative intake
recommendations to determine appropriate RDIs for vitamins and minerals
to be established for infants 7 months through 12 months of age and
children 1 through 3 years of age. Another comment recommended that
menu modeling and intake survey data should be a consideration in the
establishment of certain DRVs as they provide insight on whether a DV
is achievable, without compromising intake of another food group or
nutrient and whether they align with dietary recommendations.
    (Response) We agree dietary intake data and public health
significance are important considerations in determining appropriate
RDIs for vitamins and minerals. We consider public health significance
in the context of developing RDIs for vitamins and minerals to refer to
the existence of ``well-established'' scientific evidence from U.S.
consensus reports that there is a relationship between a nutrient and
chronic disease risk, a health-related condition, or a health-related
physiological endpoint and where the intake of such nutrient is of
general importance in the general U.S. population, e.g., where intakes
are generally too low or too high among the U.S. population. Thus, we
established RDIs for vitamins and minerals based on the DRIs set by the
IOM that reflect the most current science regarding nutrient
requirements and associated disease risk, health-related condition, or
health-related physiological endpoints (79 FR 11879 at 11926). While
the DRI reports also consider dietary intake data, we also have
analyzed more recent dietary intake data for these age groups (79 FR
11879 at 11944).
    We acknowledge the comment suggesting that menu modeling and intake
survey data could be a consideration in the establishment of certain
DRVs. Dietary recommendations based on menu modeling may aim to achieve
nutrient requirements, but are not the sole determining factor for
establishing all DRVs. We agree that menu modeling can be considered in
choosing a reference point for daily intake that is realistically
achievable and practical in light of the current food supply and
consumption patterns.
    b. Calories. The preamble to the proposed rule (79 FR 11879 at
11939) stated that we have not established a reference calorie intake
for infants. We noted that there is no quantitative intake
recommendation for calories for infants and that we were not aware of
scientific data and information on which we could rely to establish
such a level (id.). Thus, we did not propose to establish a reference
calorie intake level for infants 7 to 12 months.
    We did not receive comments on this issue. Consequently, the final
rule does not establish a reference calorie intake for infants though
12 months of age.
    c. Total fat. Regarding total fat, the IOM set an AI of 30 grams/
day for fat for infants 7 through 12 months of age based on the average
intake of human milk and complementary foods. The AI provides a basis
on which we can determine an appropriate DRV for total fat for infants
7 through 12 months, so we proposed to amend Sec.  101.9(c)(9) to
include a DRV of 30 grams for fat for infants 7 through 12 months of
age.
    We did not receive comments regarding the proposed DRV for infants,
so the final rule establishes a DRV of 30 grams for fat for infants
though 12 months of age.
    d. Saturated fat, trans fat, cholesterol, dietary fiber, and
sugars. Regarding saturated fat, trans fat, cholesterol, dietary fiber,
and sugars, there are no quantitative intake recommendations from U.S.
consensus reports available with respect to infants. Thus, we did not
propose to establish DRVs for these nutrients for infants 7 through 12
months of age.
    We did not receive comments on our decision not to establish DRVs
for saturated fat, trans fat, cholesterol, and dietary fiber for
infants. Thus, the final rule does not establish DRVs for infants
though 12 months of age for these nutrients.
    (Comment 456) One comment recommended establishing a DRV for sugars
for infants and children and suggested that we work with the IOM to
establish a DRV for sugar for this population.
    (Response) We decline to establish a DRV for sugars for infants
though 12 months of age and children 1 through 3 years of age. As
discussed in part II.H.2, we are not aware of data or information
related to a quantitative intake recommendation for sugars that we
could use as the basis for a DRV for total sugars. The IOM reviewed the
evidence on this topic in the Macronutrient report (IOM, 2002) and did
not provide quantitative intake recommendations for infants and
children.
    e. Polyunsaturated fat, monounsaturated fat, insoluble fiber,
soluble fiber, added sugars, and sugar alcohols. For polyunsaturated
fat, monounsaturated fat, insoluble fiber, soluble fiber, added sugars,
and sugar alcohols, there are no quantitative intake recommendations
from U.S. consensus reports available with respect to infants. Thus, we
did not propose to establish DRVs for these nutrients for infants 7
through 12 months of age.
    We did not receive comments on our decision not to establish DRVs
for polyunsaturated fat, monounsaturated fat, insoluble fiber, soluble
fiber, added sugars, and sugar alcohols. Thus, the final rule does not
establish DRVs for infants though 12 months of age for these nutrients.
    f. Total carbohydrates. For total carbohydrates, the IOM set an AI
of 95 grams/day for carbohydrates for infants 7 through 12 months of
age based on the average intake of human milk and complementary foods;
the 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 proposed to amend Sec.  101.9(c)(9) to establish a DRV of
95 grams for total carbohydrate for infants 7 through 12 months of age.
    We did not receive comments regarding the proposed DRV of 95 grams
for total carbohydrates for infants. Consequently, the final rule
adopts the DRV of 95 grams for total carbohydrates for infants though
12 months of age.
    g. Protein. For protein, the DV for protein for infants is an RDI,
rather than a DRV. The preexisting RDI for infants is 14 grams/day for
infants, but, in the preamble to the proposed rule (79 FR 11879 at
11940), we said we would revise the RDI to rely on current quantitative
intake recommendations and that, in 2002, the IOM established an RDA
for infants 7 through 12 months of 1.2 grams/kilogram/day based on
nitrogen balance studies and using a reference body weight of 9
kilograms. The value 1.2 grams/kilogram/day x 9 kg equals 10.8 grams/
day or a rounded value of 11 grams/day, yet we also noted that protein
intakes are well above the current and proposed RDI. Mean protein
intake for infants 6 to 11 months of age was 22 grams/day, well above
the RDA of 11 grams/day. Thus, we proposed to revise Sec.
101.9(c)(8)(iv) to establish an RDI of 11 grams for protein for infants
7 through 12 months of age.
    We did not receive comments on our proposed RDI of 11 grams for
infants, so the final rule, at Sec.  101.9(c)(7)(iii) and (c)(8)(iv),
establishes a RDI for protein of 11 grams for infants though 12 months
of age.

    h. Sodium. For sodium, we noted, in the preamble to the proposed
rule (79 FR 11879 at 11940), that 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. Thus, we
did not propose a DRV for sodium for infants 7 through 12 months of
age.
    We did not receive comments regarding a DRV for sodium for infants.
Thus, the final rule does not establish a DRV for sodium for infants
though 12 months of age.
    i. Fluoride. For fluoride, although the IOM set an AI for fluoride,
the AI for infants 7 through 12 months is close to the EPA benchmarks
for total fluoride intake. Additionally, we did not propose 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, and so, in the proposed rule, we tentatively concluded that
a DRV for fluoride is not warranted for infants 7 through 12 months.
Thus, we did not propose to establish a DRV for fluoride for infants 7
through 12 months of age.
    We did not receive comments regarding establishment of DRVs for
fluoride for infants. Thus, the final rule does not establish DRVs for
fluoride for infants though 12 months of age.
    j. Other vitamins and minerals. For vitamins and minerals, we
reviewed current quantitative intake recommendations for vitamins and
minerals for infants to determine appropriate RDIs for vitamins and
minerals to be established in regulations for infants 7 through 12
months of age. In the preamble to the proposed rule (79 FR 11879 at
11940), we explained that we considered 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, and labeling foods for this
subpopulation with percent DV declarations can help parents make
nutritious food choices. The DRIs (AIs and RDAs) provide a basis on
which to determine RDIs for vitamins and minerals for this
subpopulation. We considered it appropriate to use RDAs and, in the
absence of RDAs, AIs to determine appropriate micronutrient RDIs for
infants. We also stated that the IOM established DRIs based on
scientific knowledge that update and supersede previous RDA
recommendations. Consequently, we proposed 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 through 12 months of age.
    We did not receive comments regarding our proposed RDIs for vitamin
A, vitamin C, vitamin D, vitamin E, vitamin K, vitamin B12,
folate, choline, riboflavin, niacin, vitamin B6, calcium,
thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium,
selenium, copper, manganese, chromium, molybdenum, chloride, and
potassium for infants. Thus, the final rule adopts these RDIs for
infants though 12 months of age without change.
    (Comment 457) One comment would have us retain a DV for iron of 15
mg for infants given the importance of adequate iron in the diets of
infants and young children and the prevalence of iron deficiency in
children. The comment noted that published data reported 12 percent of
infants aged 6 to 11 months have iron intakes from food, beverages, and
supplements below the EAR (Butte 2010) and our analysis of NHANES data
showed that 17.8 percent of infants aged 7 to 12 months have iron
intakes from conventional foods only below the EAR.
    (Response) We decline to revise the rule as suggested by the
comment. We recognize the importance of adequate iron in the diets of
infants. We acknowledge the dietary intake data and prevalence of iron
deficiency for infants cited by the comment and point out that our