analysis of NHANES data showed that 3 percent of infants aged 7 to 12
months have iron intakes below the EAR from food, beverages, and
supplements. While we evaluated intakes, we consider that the DRI is
the appropriate basis for establishing the DV for iron for infants
because the DRI reports and its set of nutrient reference values are
comprehensive reviews and applications of nutrition science research
(79 FR 11879 at 11885).
    (Comment 458) One comment questioned how a decrease in the DV for
iron would affect iron fortification of foods for infants. The comment
said that such a decrease in the DV could cause manufacturers to reduce
iron fortification of products for this population group.
    (Response) We disagree with the comment. The comment did not
provide, and we are not aware of, any evidence to suggest that
decreasing the DV for iron would impact iron fortification of foods for
infants. DVs are established based on DRIs set by the IOM that reflect
the most current science regarding nutrient requirements, not on
potential changes in fortification of products. We recognize the
importance of adequate iron intake in the diets of infants and intend
to monitor the nutrient adequacy for this population and consider the
need for consumer education.
    (Comment 459) One comment asked that we use the current DV of 5 mg
for zinc for infants as the DV for infants because previous RDA panels
have recommended intakes of up to 10 mg for children 1 through 3 years
of age and now recommend a RDA of 3 mg for infants and children 1
through 3 years of age. The comment also cited a study by Walravens et
al. 1989 (Ref. 254) referenced by the IOM confirming the factorial
approach and questioned the IOM's use of the Walraven baseline data
minus 2 standard deviations to support for the EAR and suggested that
reported dietary intake data, instead of standard deviations, maybe a
more appropriate basis for EAR. The comment stated that lowering the DV
to 3 mg/day may affect the availability and level of zinc fortification
in foods and reduce intake levels without a full understanding of the
potential impact in this sensitive population.
    (Response) We decline to revise the rule as suggested by the
comment. We are changing the DVs to reflect the most recent
comprehensive reviews and applications of nutrition science research
provided by current DRI reports and its set of nutrient reference
values (see 79 FR 11879 at 11885). Modifying the reference value for
zinc provided by these consensus reports is not warranted based on the
scientific evidence to support the DRI.
    We also disagree that using reported dietary intake data may be a
more appropriate basis for the EAR infants. We note that the IOM
established the EAR for zinc using a factorial approach and did not
base the EAR on the growth data from the Walravens study (Ref. 226). We
decline to comment on the IOM's rationale for the calculation used in
confirming the factorial approach using the growth data cited by the
Walraven study. We decline to speculate on how consumers may interpret
% DV for zinc resulting from a recommended dietary pattern and whether
they may inappropriately limit zinc intake. The comment did not
provide, and we are not aware of, any evidence to suggest how consumers
will react to the changes in percent DV as a result of changes to the
DVs and whether they would inappropriately limit zinc intake. We
recognize the importance of adequate zinc intake in

the diets of infants and intend to monitor the nutrient adequacy for
this population and consider the need for consumer education.
    We also have no evidence to suggest how that decreasing the DV for
zinc would impact zinc fortification of foods for infants and decline
to speculate on how availability and level of zinc fortification may
change. DVs are established based on DRIs set by the IOM that reflect
the most current science regarding nutrient requirements and not on
potential changes in the fortification of products.
6. DRVs and RDIs for Children 1 Through 3 Years of Age
    With respect to children 1 through 3 years of age, our preexisting
regulations do not include DRVs or RDIs, except an RDI for protein of
16 grams for children less than 4 years of age. In the preamble to the
proposed rule (79 FR 11879 at 11940 through 11941), we explained that
we reviewed scientific evidence and current recommendations, as well as
comments in response to the 2007 ANPRM to consider establishing DRVs
and RDIs for nutrients for this subpopulation and to consider revisions
to the current RDI for protein.
    a. General comments.
    (Comment 460) Several comments supported establishing DVs for
children 1 through 3 years (13 through 48 months) that are consistent
with the IOM's DRI recommendations for children 1 through 3 years age
ranges.
    In contrast, one comment suggested setting DVs specific for 4- to
8-year-old children because, according to the comment, setting a single
DV that groups 4- to 8-year-old children with adults could lead to
excessive intakes of some fortified vitamins and minerals and
potentially increase the risk of adverse health effects from ingesting
too much. The comment pointed out that the updated DVs for two
nutrients, vitamin A and niacin, are the same as or higher than the IOM
Tolerable Upper Intake Levels (ULs) for 4-to-8-year-olds.
    Other comments suggested establishing RDIs and DRVs for children 4
to 13 years of age because product labeling based on RDIs for adults,
in most cases, exceed the nutritional needs for children 4 to 13 years
of age. The comments also noted that setting RDIs for children would
provide an opportunity for more companies to formulate children's
products to age-specific RDAs (rather than adult values which may not
be appropriate for children's nutritional needs) and communicate the
information to consumers via product labeling. One comment recommended
that declarations of percent DV should be required for products
targeted to children 4 through 13 years of age that contain nutrients
for which this age-specific DRV or RDI is established.
    (Response) We decline to revise the rule as suggested by the
comments. While we recognize that nutritional needs of children aged 4
to 8 or 4 to 13 years are different from adults, we disagree with
establishing RDIs for children aged 4 to 8 or 4 to 13 years due to
concerns about excessive intake of nutrients above the UL or
recommended intakes for these age groups. As noted in the preamble to
the proposed rule (79 FR 11879 at 11928) and the accompanying
memorandum to the file rule (Ref. 199), intakes of vitamins and
minerals generally do not exceed the ULs under current RDIs that are
based on a population coverage approach, except for zinc, vitamin A
(preformed), iodine and folic acid among children 4 to 8 years old. In
these few instances where total usual intakes of vitamins and minerals
by children aged 4 to 8 years exceed corresponding ULs, we have
determined that such intakes are not of public health significance.
    With respect to the comment regarding niacin, the UL for niacin
applies to niacin obtained from fortified foods and/or supplements and
is based on flushing (burning, tingling sensation and reddening flush
primarily on skin, arms and face) which is not considered a serious
adverse effect. The UL for children was set by extrapolating downward
from the UL for adults. While niacin intakes from fortified foods and
dietary supplements may exceed the UL for children aged 4 to 8 years
old (Refs. 194-195), no data were found to suggest that children have
increased susceptibility to flushing effects from excess intake (Ref.
249).
    We also disagree with establishing RDIs and DRVs for children 4 to
13 years of age and mandatory declaration of percent DV for products
targeted to children 4 through 13 years of age to provide an
opportunity for companies to formulate children's products to age-
specific RDAs rather than adult values which may not be appropriate for
children's nutritional needs. We recognize that RDAs for adults may be
higher than the RDAs of children 4 through 8 years of age and 9 through
13 years of age. RDIs are intended to help persons to understand the
relative significance of nutrients in the context of a total daily
diet, to compare foods, and to plan general diets. They are not
intended to be used to decide whether a particular individual's
consumption of nutrients is appropriate. While RDIs are not precise
values for certain age and sex groups, they function as an overall
population reference to help consumers judge a food's usefulness in
meeting overall daily nutrient requirements or recommended consumption
levels and to compare nutrient contributions of different foods.
    b. Calories. With respect to calories, we stated, in the preamble
to the proposed rule (79 FR 11879 at 11940 through 11941), that several
comments to the 2007 ANPRM supported establishing a DV for calories
specifically for young children 1 through 3 years of age and that we
considered it appropriate to establish a reference calorie intake level
for children 1 through 3 years of age because we proposed to set DRVs
using quantitative intake recommendations that are based on calories
(e.g., total fat, saturated fat, and dietary fiber). Because
recommendations from the IOM, AHA, AAP, and the 2010 DGA for caloric
intake range from 800 to 900 calories/day for children 1 year old,
approximately 1,000 calories/day for children 2 years of age, and from
1,000 to 1,200 calories/day for children 3 years of age, we used an
average of the range of these caloric intake recommendations (800 to
1,200 calories/day), i.e., 1,000 calories/day, as a reasonable
reference calorie intake level and proposed to amend Sec.  101.9(c)(9)
to provide a reference calorie intake level of 1,000 calories/day for
children 1 through 3 years of age.
    (Comment 461) One comment supported the reference calorie intake of
1,000 calories/day for children 1 through 3 years of age.
    (Response) We agree with the reference calorie intake of 1,000
calories/day for labeling represented or purported to be for children 1
through 3 years of age. Thus, the final rule, at Sec.  101.9(c)(9),
establishes a reference calorie intake of 1,000 calories/day for
children aged 1 through 3 years.
    c. Total fat. In the preamble to the proposed rule (79 FR 11879 at
11941), we noted that there is no DRV for total fat for children ages 1
through 3 years, but a comment to the 2007 ANPRM recommended that 35
percent of the recommended 1,050 calories or 41 grams/day of fat be
used to as the DRV for fat because it is the midpoint of the AAP/AHA
recommendation and the IOM Acceptable Macronutrient Distribution Range
(AMDR) for 1 through 3 year olds. We agreed that 35 percent of calories
from fat for children 1 through 3 years of age serves as an appropriate
basis on which to set the DRV for total fat and would be consistent
with AHA and AAP recommendations that 30 to 40 percent

of calories consumed by children 12 to 24 months of age and 30 to 35
percent of calories consumed by children 24 through 48 months of age
should come from fat. Therefore, we tentatively concluded that 35
percent of total calories from fat (i.e., 39 grams using the proposed
reference calorie intake level of 1,000 calories/day) is an appropriate
DRV for total fat for children 1 through 3 years of age, and we
proposed to amend Sec.  101.9(c)(9) to establish a DRV of 39 grams for
fat for children 1 through 3 years of age.
    (Comment 462) One comment would increase the DRV for total fat for
children 1 through 3 years of age to 41 grams, given the importance of
an adequate intake of total fat in this population for healthy
development and growth. The comment noted that this level of total fat
would be 37 percent of total calories from fat (based on 1,000
calories/day reference calorie intake level) which is within the AMDR
of 30 to 40 percent total calories from fat. The comment cited dietary
intake data suggesting that 23 percent (12 to 23 months) and 47 percent
(24 to 48 months) of children are below the AMDR. The comment noted
that it is important for the total fat DV to help encourage adequate
fat intake.
    (Response) We decline to increase the DRV for total fat. In the
preamble to the proposed rule (79 FR 11879 at 11941), we determined
that 35 percent of calories from fat, based on a 1,000 calorie/day
reference calorie intake level, is an appropriate basis for the DRV for
total fat because it aligns with the AHA and AAP recommendations that
30 to 40 percent of calories consumed by children 12 through 24 months
of age and 30 to 35 percent of calories consumed by children 24 through
48 months of age should come from fat and is consistent with our
proposed approach to setting the DRV for total fat for the general
population (Ref. 255). We acknowledge the dietary intake data
suggesting the total fat intake of children is below the AMDR. This
calculation yields a DRV of 39 grams.
    We disagree that the purpose of the total fat DV is to encourage
fat intake. The DVs are intended to help persons to understand the
relative significance of nutrients in the context of a total daily
diet, to compare foods, and to plan general diets. They are not
intended to be used to decide whether a particular individual's
consumption of nutrients is appropriate.
    Thus, the final rule, at Sec.  101.9(c)(9), establishes a DRV of 39
grams for total fat for children aged 1 through 3 years.
    d. Saturated fat, trans fat, and cholesterol. For saturated fat,
trans fat, and cholesterol, we stated, in the preamble to the proposed
rule (79 FR 11879 at 11941), that there are no DRVs for children 1
through 3 years of age. Based on the scientific evidence in the 2010
DGA to support that Americans 2 years of age and older consume less
than 10 percent of calories from saturated fat and less than 300 mg/day
of cholesterol, we tentatively concluded that it would be appropriate
to set a DRV of 10 grams for saturated fat, based on 10 percent of
total calories from saturated fat and using the proposed reference
calorie intake level of 1,000 calories/day, which equals 11 grams,
rounded down to 10 grams, and a DRV of 300 mg for cholesterol for
children 1 through 3 years of age. We proposed to amend Sec.
101.9(c)(9) to establish a DRV of 10 grams for saturated fat and a DRV
of 300 mg for cholesterol for children 1 through 3 years of age. We
declined to propose a DRV for trans fat because the scientific evidence
from the IOM and the 2010 DGA did not provide any specific appropriate
levels of intake.
    (Comment 463) One comment recommended using the DRV of 12 grams for
saturated fat for children 1 through 3 years of age. The comment noted
that this value represents 10.7 percent of calories from saturated fat
based on a 1,000 calorie diet and is consistent with the diets of about
25 percent of children between 12 and 47 months, an indication that
this level of intake is achievable.
    (Response) We decline to change the DRV for saturated fat as
suggested by the comment. In establishing the DRV for saturated fat, we
considered that cardiovascular disease can begin in childhood and the
scientific evidence in the 2010 DGA that support Americans 2 years of
age and older consuming less than 10 percent of calories from saturated
fat (79 FR 11879 at 11941). We disagree that the DRV for saturated fat
should be based on dietary intake data that suggest that a level of 12
grams is achievable. DVs are established based on DRIs set by the IOM
that reflect the most current science regarding nutrient requirements,
not on levels of intakes that are achievable. Thus, the final rule, at
Sec.  101.9(c)(9), establishes a DRV of 10 grams for saturated fat for
children aged 1 through 3 years. Additionally, on our own initiative,
we have replaced ``saturated fatty acids'' in the table with
``saturated fat'' for consistency in how we refer to saturated fat. We
also have replaced ``Unit of measurement'' with ``Unit of measure'' in
the table for consistency with the introductory sentence to Sec.
101.9(c)(9).
    We did not receive comments regarding our tentative decision not to
establish a DRV for trans fat or the proposed DRV of 300 mg for
cholesterol for children aged 1 through 3 years. Thus, the final rule
establishes a DRV of 300 mg for cholesterol for children aged 1 through
3 years and does not establish a DRV for trans fat.
    e. Polyunsaturated fat, monounsaturated fat, sugars, insoluble
fiber, soluble fiber, added sugars, and sugar alcohols. For
polyunsaturated fat, monounsaturated fat, sugars, added sugars,
insoluble fiber, soluble fiber, and sugar alcohols, we stated, in the
preamble to the proposed rule (79 FR 11879 at 11941), that there are no
DRVs for children 1 through 3 years of age. We recognized the essential
nature of [alpha]-linolenic acid in the diet, but we said that, for
children 1 through 3 years of age, DRIs or other data and information
were not available on which we could rely to establish DRVs for
polyunsaturated fat, monounsaturated fat, sugars, added sugars,
insoluble fiber, soluble fiber, and sugar alcohols (id.). Therefore, we
tentatively concluded that there was no basis for setting DRVs for
these nutrients and did not propose DRVs for polyunsaturated fat,
including n-3 or n-6 polyunsaturated fatty acids, monounsaturated fat,
sugars, added sugars, soluble fiber, insoluble fiber, or sugar alcohols
for children 1 through 3 years of age.
    We did not receive comments on our tentative decision not to
establish DRVs for polyunsaturated fat, monounsaturated fat, sugars,
insoluble fiber, soluble fiber, and sugar alcohols. Thus, the final
rule does not establish DRVs for children 1 through 3 years of age for
these nutrients.
    (Comment 464) Some comments agreed with not defining DVs for added
sugars. One comment recommended establishing a DRV for added sugar for
children.
    (Response) We received many comments on defining a DRV for added
sugars and explain, in part II.H.3.o, that we are establishing a DRV
for added sugars for children and adults 4 years of age and older of no
more than 10 percent of total calories, or 50 grams using a 2,000
calorie intake reference amount based on food pattern modeling. For the
reasons discussed in part II.H.3.o, we are also establishing a DRV of
25 grams of added sugars for children 1 through 3 years of age based on
food pattern modeling. Using the 1,000 calorie intake reference amount
for children 1 through 3 years of age and the DRV of no more than 10
percent of total calories, the DRV for children 1 through 3 years of
age is 25 grams (1,000

calories x 0.1 = 100 calories and 100 calories / 4 calories per gram
for carbohydrates = 25 grams). Thus, the final rule, at Sec.
101.9(c)(9), establishes a DRV of 25 grams for added sugars for
children ages 1 through 3 years of age.
    f. Total carbohydrates. In the preamble to the proposed rule (79 FR
11879 at 11941), we said that, for total carbohydrates, there is not a
DRV for children 1 through 3 years of age. We noted, however, that we
were proposing a DRV for total carbohydrate for the general population
based on the percentage of calories in a 2,000 calorie diet remaining
after the sum of the DRV for fat (30 percent) plus the DRV for protein
(10 percent) have been subtracted and that we considered this method to
be appropriate for setting a DRV for total carbohydrate for children 1
through 3 years of age (id.). We also stated that total calories (100
percent) minus the proposed DRV for total fat (35 percent of calories)
and the proposed DRV for protein (5 percent of calories) equals 60
percent of calories from total carbohydrate. A value of 60 percent of
total calories from total carbohydrates also falls within the IOM AMDR
recommendation of 45 to 65 percent of calories from carbohydrates for
children 1 through 3 years of age. Therefore, we tentatively concluded
that an appropriate DRV for total carbohydrate is 60 percent of
calories (i.e., 150 grams using the proposed reference calorie intake
level of 1,000 calories/day), and we proposed to amend Sec.
101.9(c)(9) to set a DRV of 150 grams for total carbohydrate for
children 1 through 3 years of age.
    We did not receive comments regarding the proposed DRV of 150 grams
for children 1 through 3 years of age, so the final rule adopts this
DRV without change.
    g. Dietary fiber. In the preamble to the proposed rule (79 FR 11879
at 11941), we stated that there is not a DRV for dietary fiber for
children 1 through 3 years of age, but we agreed with a comment to an
ANPRM that an AI of 14 grams/1,000 calories for dietary fiber for
children 1 through 3 years of age should be used to set a DRV for
dietary fiber to be consistent with how other proposed DRVs are being
set. Additionally, because we proposed a reference calorie intake level
of 1,000 calories/d for this subpopulation, we proposed to amend Sec.
101.9(c)(9) to establish a DRV of 14 grams for dietary fiber for
children 1 through 3 years of age.
    We did not receive comments regarding the proposed DRV of 14 grams
for fiber for children 1 through 3 years of age. Thus, the final rule
adopts this DRV without change.
    h. Protein. Under our preexisting regulations, at Sec.
101.9(c)(7)(iii), the RDI for protein for children younger than 4 years
of age was based on the 1989 RDA for protein of 16 grams/day. Taking
into account current recommendations and protein intakes, we noted, in
the preamble to the proposed rule (79 FR 11879 at 11942), that protein
intakes are well above the current RDI, with the mean protein intake
for children 12 to 23 months of age being 44 grams/day, well above the
RDA of 13 grams/day, and the midpoint of the AMDR of 5 to 20 percent
calories from protein (i.e., 12.5 percent of calories from protein or
31 grams/day). The protein AMDR for children 1 through 3 years of age
is 5 to 20 percent of calories, and the RDA is approximately 5 percent
of calories. Given the proposed reference calorie intake level and the
approaches used for the proposed DRVs for fat and carbohydrate that are
based on percent of calories, we tentatively concluded that, as with
the general population, the DV for protein for children 1 through 3
years of age should be a DRV, rather than an RDI (using the RDA) and
that a DRV for protein should be based on 5 percent of 1,000 calories
or 50 calories which equals 12.5 grams or, when rounded up, 13 grams.
We proposed to amend Sec.  101.9(c)(7)(iii) and (c)(9) to establish a
DRV for protein of 13 grams for children 1 through 3 years of age.
    (Comment 465) One comment recommended retaining the current DV of
16 grams for protein or using 10 percent of calories from protein. The
comment noted that children 24 to 47 months have 13 to 19 percent of
energy intakes from protein, respectively. The comment said that the
proposed DV of 13 grams appears to be low relative to the protein that
would be expected to be contributed from a diet that supplies the
appropriate servings of foods from the recommended food groups,
including milk, meat/poultry and beans and other legumes.
    (Response) We decline to retain a DV of 16 grams for protein. In
the preamble to the proposed rule (79 FR 11879 at 11942), we discussed
a comment to the 2007 ANPRM recommending the DV for protein be
maintained at 16 grams. We declined to keep the DV for protein at 16
grams, in part, because protein intakes are well above the current RDI.
Mean protein intake for children 12 to 23 months of age was 44 grams/
day, well above the RDA of 13 grams/day and the midpoint of the AMDR of
5 to 20 percent calories from protein (i.e., 12.5 percent of calories
from protein or 31 grams/day, which we rounded up to 13 grams). The
protein AMDR for children 1 through 3 years of age is 5 to 20 percent
of calories and the RDA is approximately 5 percent of calories. Thus, a
DRV for protein should be based on 5 percent of 1,000 calories or 50
calories which equals 12.5 grams or, when rounded up, 13 grams, and the
final rule, at Sec.  101.9(c)(7)(iii) and (c)(9), establishes a DRV for
protein of 13 grams for children 1 through 3 years of age.
    i. Sodium. In the preamble to the proposed rule (79 FR 11879 at
11942), we noted that, for the general population, we proposed to
establish a DRV based on the UL for sodium and that there is no DRV for
sodium for children 1 through 3 years of age. We also noted that the
IOM derived the UL for children 1 through 3 years of age by
extrapolation from the adult UL of 2,300 mg/day based on observational
studies showing that blood pressure increases with age into adulthood
and the recognition that risk factors for CVD, such as high blood
pressure and atherosclerosis, occur in childhood (id.). We proposed to
amend Sec.  101.9(c)(9) to establish a DRV of 1,500 mg for sodium for
children 1 through 3 years of age.
    We did not receive comments regarding the DRV of 1500 g for sodium
for children 1 through 3 years of age. Thus, the final rule, at Sec.
101.9(c)(9), establishes a DRV of 1,500 mg for sodium for children 1
through 3 years of age.
    j. Fluoride. There is not a DV for fluoride for children 1 through
3 years of age. In the preamble to the proposed rule (79 FR 11879 at
11942), we said that, although the IOM recognized fluoride as a trace
mineral that is important for public health by setting an AI based on
evidence of its role in reducing the risk of dental caries, we
tentatively concluded that a DRV should not be established for
fluoride. The proposed rule did not contain a DRV for fluoride for
children 1 through 3 years of age.
    We did not receive comments regarding the establishment of DRVs for
fluoride for children 1 through 3 years of age. Thus, the final rule
does not establish a DRV for fluoride for children 1 through 3 years of
age.
    k. Other vitamins and minerals. In the preamble to the proposed
rule (79 FR 11879 at 11942 through 11943), we stated that the IOM's
quantitative intake recommendations (AIs and RDAs) provide a basis on
which to determine RDIs for vitamins and minerals for children 1
through 3 years of age. We explained that the RDA, when available, is
the best estimate of an intake level that will meet the nutrient goals
of practically all consumers who would use the Nutrition Facts label
and that,

while AIs have less certainty than RDAs, AIs represent goals for
nutrient intake for individuals and provide the best estimate based on
current science for use in setting RDIs for such nutrients (see id.).
Therefore, using the RDAs and AIs, we proposed to amend Sec.
101.9(c)(8)(iv) to establish 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 children 1 through 3 years 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, and chloride for
children 1 through 3 years of age. Thus the final rule adopts these
RDIs for children 1 through 3 years of age without change.
    (Comment 466) One comment said that a DV for potassium of 3,000 mg
for children aged 1 through 3 years is unrealistic and may promote an
unbalanced diet. The comment said that the DV for potassium should be
calculated using a 1,000 calorie diet instead of the 1,372 calorie
factor used by the IOM for 1 through 3 year olds. The comment requested
a DV of 2,300 mg given the reference caloric intake of 1,000 for
children ages 1 through 3 years.
    Another comment expressed concern that, with a DV of 3,000 mg,
several foods products would no longer be considered a ``good source''
of potassium.
    (Response) We decline to establish a DV of 2,300 mg for potassium,
and we disagree with the comment regarding foods that would no longer
be considered as a ``good source'' of potassium. In the preamble to the
proposed rule (79 FR 11879 at 11942), we discussed how we had
considered comments to the 2007 ANPRM suggesting that we use 1,800 or
2,000 mg/day potassium as the basis for the RDI for potassium; we said
that it would be inconsistent with the approach for the general
population. Selecting a number other than a RDA or AI, when there is
one, is inconsistent with our approach for establishing DVs. We rely on
the DRI reports and its set of nutrient reference values for
establishing the DVs because they are comprehensive reviews and
applications of nutrition science research. We acknowledge that current
potassium intakes are below the proposed DV of 3,000 mg. However, we
disagree that the DV for potassium may promote an unbalanced diet.
Dietary sources of potassium are found in all food groups, notably in
vegetables and fruits, and milk and milk products (Ref. 30). Promoting
the development of healthy eating patterns that will be associated with
adequate potassium intake later in life is important because chronic
conditions such as elevated blood pressure, bone demineralization, and
kidney stones likely result from inadequate potassium intakes over an
extended period of time, including childhood (Ref. 256).
    We disagree that DVs should be set based on realistic intakes or
eligibility to make a nutrient content claim. The DVs are established
based on DRIs set by the IOM that reflect the most current science
regarding nutrient requirements, not on levels of intakes that are
achievable or eligibility to make nutrient content claims.
    (Comment 467) One comment would have us retain a DV for iron of 10
mg of children 1 through 3 years 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 dietary intake data in
children aged 12 to 24 months suggests that children may be consuming
less heme iron than assumed in the determination of the IOM EAR so the
EAR may be too low to achieve the requirement of absorbed iron.
However, the comment did not provide an amount or percentage of heme
iron being consumed from current intakes and also cited data from
published and unpublished sources.
    (Response) We decline to revise the rule as suggested by the
comment. We recognize the importance of adequate iron in the diets of
infants and young children. As for the statement that children may be
consuming less heme iron than assumed in the IOM's determination of the
EAR, as the comment provided data from one published study reflecting
dietary intake data from 2002 and did not provide estimates of the heme
iron consumed or total iron absorbed, we cannot determine from the
information provided by the comment that the EAR may be too low to
achieve the requirement of absorbed iron.
    Furthermore, selecting a number other than a RDA or AI is
inconsistent with our approach for establishing DVs. We rely on the DRI
reports and its set of nutrient reference values for establishing the
DVs because they are comprehensive reviews and applications of
nutrition science research (79 FR 11879 at 11885).
    (Comment 468) One comment questioned how a decrease in the DV for
iron would affect iron fortification of foods for toddlers. The comment
said that such a decrease in the DV could cause manufacturers to reduce
iron fortification of products for this population group.
    (Response) We disagree with the comment. The comment did not
provide, and we are not aware of, any evidence to suggest that
decreasing the DV for iron would impact iron fortification of foods for
toddlers. DVs are established based on DRIs set by the IOM that reflect
the most current science regarding nutrient requirements, not on
potential changes in fortification of products. We recognize the
importance of adequate iron intake in the diets of young children and
intend to monitor the nutrient adequacy for this population and
consider the need for consumer education.
    (Comment 469) One comment asked that we use the current DV of 5 mg
for zinc for infants as the DV for children 1 through 3 years of age
because previous RDA panels have recommended intakes of up to 10 mg for
children 1 through 3 years of age and now recommend a RDA of 3 mg for
infants and children 1 through 3 years of age. The comment also cited a
study by Walravens et al. 1989 (Ref. 254) referenced by the IOM
confirming the factorial approach and questioned the IOM's use of the
Walravens baseline data minus 2 standard deviations to support for the
EAR and suggested that reported dietary intake data, instead of
standard deviations, maybe a more appropriate basis for EAR. The
comment said that the zinc consumption from a recommended dietary
pattern for children 1 through 3 years of age would be at least 6 mg,
or 200 percent of the proposed DV and that consumers would likely be
confused by these high amounts per serving and could take steps to
inappropriately limit zinc intake. The comment stated that lowering the
DV to 3 mg/day may affect the availability and level of zinc
fortification in foods and reduce intake levels without a full
understanding of the potential impact in this sensitive population.
    (Response) We decline to revise the rule as suggested by the
comment. We are changing the DVs to reflect the most recent
comprehensive reviews and applications of nutrition science research
provided by current DRI reports and its set of nutrient reference
values (see 79 FR 11879 at 11885).

    We also disagree that using reported dietary intake data may be a
more appropriate basis for the EAR children 1 through 3 years of age.
We note that the IOM established the EAR for zinc using a factorial
approach and did not base the EAR on the growth data from the Walravens
study (Ref. 226).
    The comment did not provide, and we are not aware of, any evidence
to suggest how consumers will react to the changes in percent DV as a
result of changes to the DVs and whether they would inappropriately
limit zinc intake. We recognize the importance of adequate zinc intake
in the diets of young children and intend to monitor the nutrient
adequacy for this population and consider the need for consumer
education.
    We also have no evidence to suggest how that decreasing the DV for
zinc would impact zinc fortification of foods for toddlers and decline
to speculate on how availability and level of zinc fortification may
change. DVs are established based on DRIs set by the IOM that reflect
the most current science regarding nutrient requirements and not on
potential changes in the fortification of products.
7. DRVs and RDIs for Pregnant Women and Lactating Women
    The proposed rule would establish certain DRVs and RDIs for
pregnant women and lactating women.
    a. Calories. The proposed rule would use the 2,000 reference
calorie intake level for setting DRVs for pregnant women and lactating
women (Sec.  101.9(c)(9)). In the preamble to the proposed rule (79 FR
11879 at 11943), we explained that the calorie needs for pregnant women
and lactating women are similar to the general population, and few
products are purported for pregnant and lactating women. Thus, because
the reference calorie intake for the general population is 2,000, we
proposed to use the 2,000 reference calorie intake level for setting
DRVs for pregnant women and lactating women (Sec.  101.9(c)(9)).
    We did not receive comments on our proposed 2,000 reference calorie
intake level for setting DRVs for pregnant women and lactating women.
Thus, we have finalized the provision without change on this point.
However, on our own initiative, we have made a grammatical change to
the rule's mention of ``pregnant and lactating women'' to refer,
instead, to ``pregnant women and lactating women.'' We have made this
change to clarify that the rule is referring to two groups (pregnant
women and lactating women) instead of one group.
    b. Total fat, saturated fat, cholesterol, total carbohydrate,
sodium, and dietary fiber. For total fat, saturated fat, cholesterol,
total carbohydrate, sodium, and dietary fiber, we explained, in the
preamble to the proposed rule (79 FR 11879 at 11943), that the
quantitative intake recommendations for total fat, saturated fat,
cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant
and lactating women are generally similar to the general population.
Thus, we tentatively concluded that the DRVs for total fat, saturated
fat, cholesterol, total carbohydrate, sodium, and dietary fiber for
pregnant and lactating women should remain the same as for the general
population, and so we proposed to amend Sec.  101.9(c)(9) to establish
DRVs for pregnant and lactating women using the proposed DRVs for the
general population for total fat, saturated fat, cholesterol, total
carbohydrate, sodium, and dietary fiber.
    We did not receive comments on our proposal to establish DRVs for
total fat, saturated fat, cholesterol, total carbohydrate, sodium, and
dietary fiber for pregnant and lactating women based on the DRVs for
the general population for total fat, saturated fat, cholesterol, total
carbohydrate, sodium, and dietary fiber. Thus, we have finalized these
provisions without change.
    c. Trans fat, polyunsaturated fat, monounsaturated fat, insoluble
fiber, soluble fiber, sugars, added sugars, and sugar alcohols. For
trans fat, polyunsaturated fat, monounsaturated fat, soluble fiber,
insoluble fiber, sugars, added sugars, and sugar alcohols, in the
preamble to the proposed rule (79 FR 11879 at 11943), we said that we
did not propose DRVs for these nutrients for the general population
because of a lack of quantitative intake recommendations. Because
quantitative intake recommendations are lacking for these nutrients for
pregnant and lactating women, we did not propose to establish DRVs for
trans fat, polyunsaturated and monounsaturated fat, soluble fiber,
insoluble fiber, sugars, added sugars, or sugar alcohols for pregnant
and lactating women.
    We did not receive comments on our proposal not to establish DRVs
for trans fat, polyunsaturated and monounsaturated fat, insoluble
fiber, soluble fiber, sugars, or sugar alcohols for pregnant and
lactating women. Thus, the final rule does not establish DRVs for trans
fat, polyunsaturated and monounsaturated fat, insoluble fiber, soluble
fiber, sugars, or sugar alcohols for pregnant and lactating women.
    However, with respect to added sugars, we received many comments on
defining a DRV for added sugars for children and adults 4 years of age
and older and explain, in part II.H.3.o, that we are establishing a DRV
for added sugars for children and adults 4 years of age and older of no
more than 10 percent of total calories, or 50 grams using a 2,000
calorie intake reference amount based on food pattern modeling. For the
reasons discussed in part II.H.3.o, we also are establishing a DRV for
added sugars for pregnant women and lactating women of no more than 10
percent of total calories, or 50 grams using a 2,000 calorie intake
reference amount based on food pattern modeling. Thus, the final rule
at Sec.  101.9(c)(9), establishes a DRV of 50 grams for added sugars
for pregnant women and lactating women.
    d. Protein. Our preexisting regulations, at Sec.  101.9(c)(7)(iii),
establish RDIs of 60 grams of protein for pregnant women and 65 grams
of protein for lactating women based on the highest 1989 RDAs for
pregnant and lactating women. In the preamble to the proposed rule (79
FR 11879 at 11943), we noted that the IOM established 71 grams/day
protein as the RDA for pregnant and lactating women based on the needs
for maternal and fetal development and human milk production. Because
the RDA for protein during both pregnancy and lactation is the same,
and given that most foods represented or purported to be specifically
for pregnant women are also represented or purported to be specifically
for lactating women, we tentatively concluded that it would be
appropriate to establish a single RDI of 71 grams applicable to both
pregnant and lactating women and that the DV for protein for pregnant
and lactating women should remain an RDI (using the RDA) instead of a
DRV because the DRV approach used to calculate protein for the general
population based on 10 percent of 2,000 calories, which equals 50 grams
of protein/day, falls short of the recommended protein needs of
pregnant and lactating women of 71 grams/day. Thus, we proposed to
amend Sec.  101.9(c)(7)(iii) to establish an RDI of 71 grams for
protein for pregnant and lactating women.
    We did not receive comments on the proposed RDI of 71 grams for
protein for pregnant and lactating women. Thus, we have finalized this
provision without change.
    e. Fluoride. For fluoride, we did not propose to establish a DRV
for pregnant or lactating women because we were not proposing a DRV for
fluoride in the general population.
    We did not receive comments regarding the establishment of a DRV
for fluoride for pregnant and lactating

women. Thus, the final rule does not establish a DRV for fluoride for
pregnant and lactating women.
    f. Vitamins and minerals. For vitamins and minerals, in the
preamble to the proposed rule (79 FR 11879 at 11943), we considered it
appropriate to establish RDIs for pregnant and lactating women for
vitamins and minerals that have DRIs, using population-coverage RDAs
and AIs, instead of population-weighted EARs. We proposed to establish
a single set of RDIs intended for both pregnant women and lactating
women because nutrient needs during pregnancy and lactation are
similar. Thus, we proposed to amend Sec.  101.9(c)(8)(iv) to establish
RDIs as set forth previously for vitamin A, vitamin C, vitamin D,
vitamin E, vitamin K, vitamin B12, folate, choline,
riboflavin, niacin, vitamin B6, calcium, iron, thiamin,
biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc,
selenium, copper, manganese, chromium, molybdenum, chloride, and
potassium for pregnant and lactating women.
    We did not receive comments with respect to these DRVs and RDIs for
pregnant and lactating women, and so we have finalized these provisions
without change.

P. Dietary Supplements

    Our preexisting regulations specific to dietary supplement
nutrition labeling appear in Sec.  101.36. Many requirements in Sec.
101.36 are consistent with the requirements for the nutrition labeling
of conventional foods in Sec.  101.9, and there are references
throughout Sec.  101.36 to requirements established in Sec.  101.9.
    The proposed rule would amend both the content and format of the
Supplement Facts label to correspond to the Nutrition Facts label.
1. Mandatory Dietary Ingredients
    Our preexisting regulations, at Sec.  101.36(b)(2), provide
information on dietary ingredients that have an RDI or a DRV as
established in Sec.  101.9(c)(8)(ii) and (c)(9). These dietary
ingredients are known as the ``(b)(2)-dietary ingredients.'' Of these
15 nutrients, vitamin A, vitamin C, calcium, and iron must be listed in
the Supplement Facts label for a dietary supplement when the
quantitative amount by weight exceeds the amount that can be declared
as zero in the nutrition labeling of foods in accordance with Sec.
101.9(c). Section 101.36(b)(2) states that any (b)(2)-dietary
ingredients that are not present, or that are present in amounts that
can be declared as zero in Sec.  101.9(c), must not be declared (e.g.,
amounts corresponding to less than 2 percent of the RDI for vitamins
and minerals). The regulation also requires, in Sec.  101.36(b)(2),
that calories from saturated fat and polyunsaturated fat,
monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol,
other carbohydrate, and Sec.  101.9(c)(8)(iv) or (c)(9) vitamins and
minerals other than vitamin A, vitamin C, calcium, and iron may be
declared, but they must be declared when they are added to the product
for purposes of supplementation, or when a claim is made about them.
    We proposed to update the list of (b)(2)-dietary ingredients to
maintain consistency with the proposed requirements for nutrition
labeling of foods in Sec.  101.9. Therefore, proposed Sec.
101.36(b)(2)(i) would: (1) No longer require declaration of vitamin A,
vitamin C, or Calories from fat; (2) require vitamin D and potassium;
(3) require the declaration of added sugars; and (4) retain the other
(b)(2)-dietary ingredients as mandatory declarations. We also proposed
to amend Sec.  101.36(b)(2)(i), (b)(2)(i)(B)(1), and (b)(2)(iii)(G) to
remove the requirement for declaration of ``Calories from fat.''
    We did not receive comments on these proposed changes to the
Supplement Facts label, and so, with the exception of replacing
``sugars'' with ``total sugars'' in Sec.  101.36(b)(2)(i), we have
finalized the provisions without change.
    We note that we did receive comments, in general, on removing the
declaration of vitamins A and C and on requiring the declaration of
vitamin D and potassium; we discuss those comments in part II.L.2 and
II.L.3. We also received comments on removing the requirement for
declaration of ``Calories from fat;'' we discuss those comments in part
II.E.1.
2. Folate and Folic Acid
    The preamble to the proposed rule (79 FR 11879 at 11947) explained
that folate is a nutrient found in conventional foods, whereas folic
acid is the synthetic form of folate that is added to fortified
conventional foods and dietary supplements. Because of the difference
in bioavailability between naturally occurring folate and synthetic
folic acid, we proposed to:
     Amend Sec.  101.9(c)(8)(v) such that the term ``folate''
would be used in the labeling of conventional foods that contain either
folate alone or a mixture of folate and folic acid;
     amend Sec.  101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to
specify that ``folic acid'' is the term used to declare folic acid
content of dietary supplements; and
     remove ``folate'' and ``folacin'' from the list of
synonyms that may be used to declare folic acid on the Supplement Facts
label.
    (Comment 470) Many comments opposed allowing only the use of the
term ``folic acid'' on dietary supplements. The comments said that
dietary supplements can contain folate.
    (Response) As discussed in part II.N.3.b, the final rule requires
that the Supplement Facts label declare folate in mcg DFE, a percent DV
based on mcg DFE, and that the mcg of folic acid be stated in
parenthesis when folic acid is added as a nutrient supplement to a
dietary supplement. In doing so, there will be consistency with the use
of the term folate in labeling of both conventional foods and dietary
supplements. In addition, the mcg DFE reflects the fact that folic acid
is more bioavailable than folate and is the basis of the DV. By
requiring the declaration of the mcg DFE folate, a percent DV based on
mcg DFE, and the mcg of folic acid in parentheses on dietary
supplements when folic acid is added as a nutrient supplement,
consumers will be aware of the type and amount of folate or folic acid
in the dietary supplement.
    The final rule also 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)(B)(2) because we are now
requiring that the terms ``folate'' and ``folic acid'' be included,
when declared, on both the Nutrition and Supplement Facts label.
3. Units of Measure
    The proposed rule would amend Sec.  101.9(c)(8)(iv) to replace
``IU'' for the RDIs for vitamin A, vitamin D, and vitamin E with mcg
RAE for vitamin A, mcg for vitamin D, and mg [alpha]-tocopherol for
vitamin E. The proposed rule would quantify and declare folate and
folic acid in ``mcg DFE'' instead of ``mcg.'' For consistency in
nutrition labeling of foods and dietary supplements, the proposed rule
also would amend Sec.  101.36(b)(2)(i)(B)(3) to require that, when
[beta]-carotene is included in parentheses following the percent
statement for vitamin A, it should be declared using ``mcg''
(representing mcg RAE) as the unit of measure. In addition, under Sec.
101.36(b)(2)(ii)(B), the

proposed units of measure for vitamin D, vitamin E, and folate in Sec.
101.9(c)(8)(iv) would be used in the declaration of vitamin D, vitamin
E, and folic acid in the Supplement Facts label.
    (Comment 471) Some comments disagreed with our proposal to replace
``IU'' for the RDIs for vitamin A, vitamin D, vitamin E with mcg RAE
for vitamin A, mcg for vitamin D, and mg [alpha]-tocopherol for vitamin
E.
    (Response) We address these comments in part II.N.4. The final
rule, at Sec.  101.9(c)(8)(iv), revises the units of measure to be mcg
RAE for vitamin A, mcg for vitamin D (with the allowance of voluntary
declaration of IUs), and mg [alpha]-tocopherol for vitamin E, and Sec.
101.36(b)(2)(ii)(B), therefore, adopts the same units of measure for
vitamin D, vitamin E, and folate.
    Additionally, we did not receive comments on the proposed changes
to the declaration of [beta]-carotene at Sec.  101.36(b)(2)(i)(B)(3),
so we have finalized that provision without change.
    (Comment 472) One comment said we should adopt a unit of measure
for fluoride of mg per liter (mg/L) rather than mg/servings.
    (Response) We address this comment in part II.K.3. The final rule
does not adopt mg/L as the unit of measure for fluoride.
    (Comment 473) The proposed rule, at Sec.  101.36(b)(2)(ii)(A),
would state that amounts must be expressed in the increments specified
in Sec.  101.9(c)(1) through (c)(7), which includes increments for
sodium. One comment said we should permit the use of additional units
of measure for dietary ingredients to allow for use of more appropriate
units of measure when metric weight is not the most accurate way to
express the quantity of the dietary ingredient. The comment gave
examples of ``colony forming unit'' (CFU) for probiotics and enzyme
assay units (e.g. HUT, PC, SU, ALU) for enzymes. Another comment would
amend Sec.  101.36(b)(2)(ii)(A) to state ``these amounts shall be
expressed in metric or other appropriate units of measure.''
    (Response) We decline to permit the use of additional units of
measure for dietary ingredients. The comment provided the examples of
CFUs for probiotics and enzyme assay units for enzymes; however, the
broader change suggested in the comment, by including ``other
appropriate units of measure,'' would allow for the use of units of
measure for dietary ingredients other than just probiotics and enzyme
assay units.
    We recognize that manufacturers are using a number of different
units of measure for probiotics, enzymes, and other dietary
ingredients. We need to fully evaluate each unit of measure for dietary
ingredients to determine if it is appropriate for use on the Supplement
Facts label, and if there are any implications to allowing for the use
of such units of measure on the label. Because of the complexity of
these labeling concerns, we plan to issue information related to this
subject at a later date. We have, therefore, finalized Sec.
101.36(b)(2)(ii)(A) without change.
4. Order of Nutrients Declared on the Label
    For dietary supplements, Sec.  101.36(b)(2)(i)(B) specifies that
vitamins and minerals must be declared in a specific order on the
Supplement Facts label. The proposed rule would add choline to the list
of ordered nutrients in Sec.  101.36(b)(2)(i)(B) and that, when
declared, choline must follow potassium on the label.
    We proposed to amend Sec.  101.9(c)(5) to provide for the voluntary
declaration of fluoride, unless a claim about fluoride, in which case
fluoride would be mandatory on the label. We inadvertently did not
propose to add fluoride to the list of ordered nutrients for
declaration on the Supplement Facts label in Sec.  101.36(b)(2)(i)(B).
    We did not receive any comments on the proposed addition of choline
to the list of nutrients on the Supplement Facts label. Therefore, the
final rule adds choline to the list of nutrients in Sec.
101.36(b)(2)(i)(B) and requires it to appear after pantothenic acid on
the label because choline is a vitamin and pantothenic acid is the last
vitamin in the list of nutrients provided in Sec.  101.36(b)(2)(i)(B).
In addition, the final rule specifies that calcium and iron shall be
declared after choline on the label because choline will now be
declared after pantothenic acid on the label.
    As for fluoride, to enable manufacturers to know where to declare
fluoride on the Supplement Facts label, we are adding fluoride to the
end of the list of nutrients in Sec.  101.36(b)(2)(i)(B) such that,
when it is declared, it should be placed below potassium on the
Supplement Facts label.
5. Subpopulations
    The preamble to the proposed rule (79 FR 11879 at 11947) indicated
that, to maintain consistency with the proposed requirements for
nutrition labeling of foods in Sec.  101.9, we would revise portions of
Sec.  101.36 pertaining to labeling requirements for foods, other than
infant formula, that are represented or purported to be specifically
for infants 7 through 12 months, children 1 through 3 years, and
pregnant and lactating women. The proposed rule would amend Sec.
101.36(b)(2)(iii) to state that the percent of the DV of all dietary
ingredients declared under Sec.  101.36(b)(2)(i) must be listed, except
that the percent DV for protein may be omitted as provided in Sec.
101.9(c)(7) and that no percent DV is to be given for subcomponents for
which DRVs have not been established.
    When the percent DV is declared for total fat, saturated fat, total
carbohydrate, dietary fiber, or protein, our existing regulations
require that a symbol be placed next to the percent DV declaration for
these nutrients that refers the consumer to a statement at the bottom
of the label that says ``Percent Daily Values are based on a 2,000
calorie diet.'' This statement is only accurate for products meant for
children and adults that are 4 years of age and older. In the preamble
to the proposed rule (79 FR 11879 at 11947), we explained that the
proposed DRVs for total fat, total carbohydrate, dietary fiber, and
protein for children 1 through 3 years of age are based on a 1,000
calorie diet, so, when a product that is represented or purported to be
for children 1 through 3 years of age contains a percent DV declaration
for total fat, total carbohydrate, dietary fiber, or protein, the
proposed rule would require, in Sec.  101.36(b)(2)(iii)(D), that a
symbol be placed next to the percent DV declaration that refers the
consumer to a statement at the bottom of the label that says ``Percent
Daily Values are based on a 1,000 calorie diet.''
    The proposed rule also would amend Sec.  101.36(b)(2)(iii)(E) to
change the categories of infants and children less than 4 years of age
to infants 7 through 12 months of age and children 1 through 3 years of
age, and, because we are proposing DRVs for various nutrients for
infants 7 through 12 months, children 1 through 3 years, and pregnant
and lactating women, amend Sec.  101.36(b)(2)(iii)(F) such that the
requirement for an asterisk noting that a DV has not been established
would be applicable to foods for these subpopulations only when a DRV
has not been established for a nutrient (i.e., for saturated fat,
cholesterol, or dietary fiber for dietary supplements that are
represented or purported to be for use by infants 7 through 12 months).
    We did not receive comments specific to subpopulations and the
proposed changes to Sec.  101.36, and so, except as described in our
response to comment 474, we have finalized those provisions without
change. As discussed in our

response to comment 441, we are using the terminology ``infants through
12 months of age'' throughout Sec.  101.36. As discussed in part
II.O.7.a, we also have decided to use the terminology ``pregnant women
and lactating women'' rather than ``pregnant and lactating women'' to
clarify that the rule is referring to two groups (pregnant women and
lactating women) instead of one group.
6. Footnote
    The Supplement Facts label can bear a footnote stating that the
percent Daily Values are based on a 2,000 calorie diet. In the preamble
to the proposed rule (79 FR 11879 at 11947 through 11948), we noted
that we intended to modify the footnote on the Nutrition Facts label
and to conduct consumer studies related to the footnote on the
Nutrition Facts label. We also noted that the footnote for the
Supplement Facts label differs from the footnote for Nutrition Facts
label, yet we expected that consumers who buy dietary supplements would
be more interested in information about the amount of specific
micronutrients contained in dietary supplements and would be less
focused on the caloric reference value used in determining the percent
DV for macronutrients (id.). We said that, based on the results of the
consumer study, we would consider whether it is necessary to make
corresponding changes to the footnote used on the Supplement Facts
label when certain macronutrients are declared, and we invited comment
on whether we should change the footnote on the Supplement Facts label
to be consistent with the footnote on the Nutrition Facts label.
    (Comment 474) One comment said there should be no footnote on the
Supplement Facts label. The comment said that consumers do not receive
their nutrition solely from a supplement, so, according to the comment,
there is no need to refer to total calories. In addition, because all
nutrition calculations are being made from the 2,000 calorie total, the
comment said that the information provided by the footnote is already
standardized across industry, so the footnote is unnecessary.
    (Response) We decline to remove the footnote from the Supplement
Facts label. Our preexisting regulations, at Sec.
101.36(b)(2)(iii)(D), require manufacturers to declare the footnote
``Percent Daily Values are based on a 2,000 calorie diet'' only when
total fat, saturated fat, total carbohydrate, dietary fiber, or protein
are declared. The final rule amends Sec.  101.36(b)(2)(iii)(D)) to
include added sugars in the list of macronutrients to be consistent
with the final requirement to include a declaration for added sugars in
the nutrition label. As with the declaration of the footnote statement
on the Nutrition Facts label, the footnote statement on the Supplement
Facts label provides context for the consumer and enables the consumer
to better judge how the nutrients in the supplement contributes towards
the total daily diet. Therefore, we decline to remove the footnote
statement from the Supplement Facts label.
    When the food is purported to be for children 1 through 3 years of
age, the final rule requires footnote to state that ``Percent Daily
Values are based on a 1,000 calorie diet'' because a 1,000 calorie
reference caloric value is used when calculating percent DVs for
children 1 through 3 years of age. Therefore, the final rule amends
Sec.  101.36(b)(2)(iii)(D) to require the footnote statement ``Percent
Daily Values are based on a 2, 000 calorie diet'' on the Supplement
Facts label when the percent DV for total fat, saturated fat, total
carbohydrate, dietary fiber, protein, or added sugars is declared on
the label, and to require the footnote statement ``Percent Daily Values
are based on a 1,000 calorie diet'' if the product is represented or
purported to be for use by children 1 through 3 years of age and, if
the percent DV is declared for total fat, total carbohydrate, dietary
fiber, protein, or added sugars.
7. Miscellaneous Comments
    Several comments raised other issues regarding dietary supplements
and labeling.
    (Comment 475) One comment said that the current method of labeling
dietary supplements causes confusion regarding which micronutrients,
especially vitamins and minerals, are added to a product as opposed to
those that are naturally occurring within the product. The comment
suggested that the terminology ``naturally occurring'' be used when
nutrients are naturally present in ingredients or products, and that
other terms, such as ``added,'' be used when ingredients containing
micronutrients have been added to a product.
    Another comment objected to the nomenclature we proposed for the
declaration of certain vitamins and minerals, suggesting the
limitations in nomenclature are unconstitutional under the First
Amendment (citing Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999);
reh'g, en banc, denied, 172 F.3d 72 (D.C. Cir. 1999)) and stating that
the nomenclature prevents the dissemination of information helpful to
the public in evaluating health implications of supplements. For
example, the comment stated that calling tocotrienols vitamin E is not
accurate because these forms of vitamin E differ from other forms of
vitamin E. The comment also noted that the proposed rule does not
distinguish between different forms of vitamin K, selenium, vitamin
B12, vitamin B6, and vitamin B3 for
purposes of identifying on the label the actual ingredient that is
contained in a dietary supplement product. The comment suggested that
the identification of the actual form of vitamin B3 that is
included in the product is essential because of the physiological
differences between these forms. For example, vitamin B3
could be identified as niacin or niacinamide; and similarly, vitamin
B12 could be methylcobalamin or cyanocobalamin; vitamin
B6 could be pyridoxal 5-phosphate or pyridoxine; vitamin K
could be phylloquinone or menaquione; selenium could be
selenomethionine or sodium selenite or selenocysteine. The comment also
cited references to suggest selenium in different forms has been
reported to have different effects. Furthermore, the comment noted that
the name of a nutrient ingredient in a dietary supplement may be a
structure/function claim because the form of the molecule determines
its function. For example, the comment stated that gamma-tocopherol
denotes a particular structure of vitamin E that has a particular
function because of its structure.
    (Response) With respect to the comment related to added versus
naturally occurring micronutrients in dietary supplement products, we
decline to revise the rule as suggested by the comment. In dietary
supplement products, when terms such as ``naturally occurring'' are
used to refer to micronutrients in dietary supplements, they may imply
that there is an inherent difference in nutritional quality of the
vitamin depending on its source. We are not aware of any evidence that
this is the case. Typically, ``added'' nutrients are synthetic forms of
the nutrient. As stated in Sec.  101.9(k)(4), a food is misbranded if
its labeling suggests or implies that a natural vitamin is superior to
an added or synthetic vitamin.
    With respect to the comment objecting to the nomenclature we
proposed for the declaration of certain vitamins and minerals, the
comment seems to misunderstand our requirements for the declaration of
vitamins and minerals and for structure or function claims. We provide
for the truthful, nonmisleading labeling of

nutrients in their varying forms on dietary supplements in Sec.
101.36(b) and (d) and Sec.  101.9(c). Our regulation (21 CFR
101.36(b)(2)) provides for the labeling on the nutrition label of
dietary ingredients with RDIs such as vitamins or minerals listed in
Sec.  101.9(c)(8)(iv), with the exception of vitamin B3. We
discussed, in the preamble to the proposed rule (79 FR 11879 at 11925)
and also in part II.M (Reference Daily Intakes for Vitamins and
Minerals), the reference intakes for vitamins and minerals listed in
the Nutrition Facts and Supplement Facts panels that are identified in
Sec.  101.9(c)(8)(iv). The RDIs for vitamins and minerals are based on
the IOM RDAs or AIs. In some cases, the RDA is based on the form of a
vitamin or mineral recognized to meet human requirements (i.e., the
[alpha]-tocopherol form of vitamin E) and the AI is based on intakes of
a specific form of the vitamin or mineral (i.e., phylloquinone form of
vitamin K). With the exception of vitamin B3, we note that
Sec.  101.9(c)(8)(iv) lists the common and usual names of vitamins and
minerals. The dietary supplement label requirements at Sec.  101.36(d)
provide for labeling of the source ingredient that supplies a dietary
ingredient (i.e. niacin, vitamin B12, vitamin B6,
vitamin K, and selenium) within the nutrition label in parentheses
immediately following or indented beneath the name of a dietary
ingredient and preceded by the words ``as'' or ``from,'' e.g.,
``Calcium (as calcium carbonate).'' 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). In addition,
dietary ingredients, such as menaquinone, that are ``other dietary
ingredients'' within the meaning of Sec.  101.36(b)(3) must be declared
by their common or usual name when they are present in a dietary
supplement in accordance with that section. Thus, the forms of vitamins
and minerals contained in dietary supplements such as niacinamide;
methylcobalamin or cyanocobalamin; pyridoxal 5-phosphate or pyridoxine;
phylloquinone or menaquione; and selenomethionine, sodium selenite, or
selenocysteine may be identified, as appropriate, in the Nutrition
Facts label or the ingredient statement.
    Although we do not recognize the term vitamin B3 and
instead list niacin in Sec.  101.9(c)(8)(iv), the term ``vitamin
B3'' if identified in labeling, other than in the Nutrition
Facts label, must be truthful and not misleading. Furthermore, we
disagree that we are requiring misinformation by calling tocotrienols
vitamin E and lumping these forms of vitamin E together. As we discuss
in part II.M, we established the RDI for vitamin E based on [alpha]-
tocopherol Sec.  101.9(c)(8)(iv). In Sec.  101.36, we provide for
dietary ingredients, such as tocotrienols for which we have not
established RDI's or DRV's and that are not subject to regulation under
paragraph (b)(2) of this section, as ``other dietary ingredients'' in
Sec.  101.36(b)(3). If other statements are made about ``other dietary
ingredients,'' the statements must be consistent with the all
applicable statutory and regulatory requirements.
    To the extent the comment suggests that our regulations limit the
information about the form of a nutrient on the label, we disagree.
Although we have specific requirements related to nomenclature for the
nutrient declarations, there are ways to convey the source of the
nutrient in labeling, and thus, we do not restrict information about
the source of the nutrient, provided the information presented is
consistent with our statutory and regulatory requirements.
    With respect to the comment that the name of a nutrient may be a
structure or function claim, a structure or function claim is described
in section 403(r)(6)of the FD&C Act. Such a claim is a statement that
describes the role of a nutrient or dietary ingredient intended to
affect the structure or function in humans or that characterizes the
documented mechanism by which a nutrient or dietary ingredient acts to
maintain such structure or function (section 403(r)(6)(A) of the FD&C
Act). Gamma-tocopherol is a name for a particular form of tocopherol.
While the molecular form of a vitamin may result in a particular
function, the name of the form does not describe the role of the
dietary ingredient in affecting the structure or function in humans nor
does it describe a documented mechanism by which the dietary ingredient
acts to maintain such structure or function. Thus, structure or
function claims are permitted for dietary ingredients provided they
meet the applicable statutory and regulatory requirements for such
claims.
    (Comment 476) One comment said there is confusion whether nutrient
declarations on the Supplement Facts label represent only the added
nutrients or the total amount of a nutrient based on analysis of the
finished product in products where either micronutrients have been
added or botanical ingredients are present that are natural sources of
particular micronutrients. The comment suggested we could resolve the
issue by ensuring that, where micronutrients are listed on the
Supplement Facts and/or Nutrition Facts label, the information reflects
those micronutrients that are typically present at the end of the
shelf-life period in the finished product, taking into account
industry-accepted overages/tolerances.
    (Response) The Supplement Facts label provides the nutrition
information for nutrients that have a RDI or a DRV as established in
Sec.  101.9(c). A (b)(2)-dietary ingredient may only be listed if it is
a quantitative amount by weight that exceeds the amount that can be
declared as zero in Sec.  101.9(c). We are aware that micronutrients
are sometimes added to naturally occurring micronutrients. The value
declared on the label should be the value that is supported by data
that factors in variability generally recognized for the analytical
method used for the finished dietary supplement product for the level
involved. We disagree that the label declaration should be based on a
shelf-life period because the Dietary Supplement Good Manufacturing
Practices regulations do not require an expiration date, shelf-life
date, or ``best if used by'' date (see 72 FR 34752 at 34912 and 34856).
Therefore, not all products would have a shelf-life date that could be
used when determining what the final value should be.
    (Comment 477) Several comments opposed decreasing the RDIs for
vitamins and minerals because of the impact on the dietary supplement
industry. The comments also stated that decreasing the RDIs for
vitamins and minerals makes it difficult for consumers to get
therapeutic dosages of vitamins and minerals in one supplement.
    (Response) We address these comments in part II.M.
8. Compliance Requirements for Dietary Supplements
    Compliance for dietary supplements is currently determined in
accordance with Sec.  101.9(g)(1) through (g)(8), except that the
sample for analysis must consist of a composite of 12 subsamples
(consumer packages) or 10 percent of the number of packages in the same
inspection lot, whichever is smaller, randomly selected to be
representative of the lot. The regulation also says that the criteria
on class I and class II nutrients given in Sec.  101.9(g)(3) and (g)(4)
are applicable to other dietary ingredients.
    The proposed rule would require manufacturers to declare added
sugars on the Supplement Facts label under Sec.  101.36(b)(2)(i). It
would also require manufacturers to make and keep records to verify the
amount of dietary fiber,

soluble fiber, insoluble fiber, added sugars, vitamin E, and folate,
under certain circumstances for foods (79 FR 11879 at 11956). The
proposed rule, at Sec.  101.9(g)(10) and (g)(11), also would establish
recordkeeping requirements for foods that contain a mixture of dietary
fiber and added non-digestible carbohydrate(s) that does not meet the
definition of dietary fiber, foods that contain a mixture of soluble
fiber and added non-digestible carbohydrate(s) that does not meet the
definition of dietary fiber, foods that contain a mixture of insoluble
fiber and added non-digestible carbohydrate(s) that does not meet the
definition of dietary fiber, foods that contain a mixture of naturally
occurring and added sugars, foods that contain added sugars that are
reduced through non-enzymatic browning and/or fermentation, foods that
contain a mixture of all rac-[alpha]-tocopherol and RRR-[alpha]-
tocopherol, and foods that contain a mixture of folate and folic acid.
    The same records requirements in Sec.  101.9(g)(10) and (g)(11)
also should apply to dietary supplements. Therefore, the final rule
revises Sec.  101.36(f)(1) to include the recordkeeping requirements
for specific nutrients under Sec.  101.9(g)(10) and (g)(11).
    Manufacturers of dietary supplements may request an alternative
means of compliance or additional exemptions under Sec.  101.36(f)(2)
when it is technologically feasible, or some other circumstance makes
it impracticable, for firms to comply with the requirements of the
regulation. This allowance is the similar to what is made for
conventional foods under Sec.  101.9(g)(9). Therefore, the final rule,
at Sec.  101.36(f)(2), does not refer to Sec.  101.9(g)(9).

Q. Format

    Under our preexisting regulations (see, e.g., Sec.  101.9(d)
through (f) and (j)), nutrition information must be presented on food
labels in a specific format. The elements of format related to the
Nutrition Facts label include such features and graphic design
principles as the type style (i.e., font) and size of the type (i.e.,
point); use of boldface, lines, and bars; arrangement of information in
one or more columns; column headings; presence of a footnote and use of
a symbol (such as an asterisk) to designate a footnote; and whether
nutrition information is listed as a percentage or in absolute (i.e.,
quantitative) amounts. The elements of format also include the
alignment of information; whether indentations are used in listing
nutrient data; and the use of white space (or negative space) where no
image or text exists. The format may differ from package to package
according to the amount of space on the package that is available for
labeling, as described and detailed in the relevant sections in this
document.
    The original format of the Nutrition Facts label was informed by a
number of factors, including consumer research that we conducted;
consideration of the environment in which consumers typically use the
label (i.e., grocery stores); the diversity of consumers (i.e., with
respect to education, age, socioeconomic status, etc.) for whom the
label is intended; and comments and data received on this issue in
response to rulemaking activities conducted in the 1990s. Research
studies consistently confirmed that simple formats are easier to
comprehend and require less consumer effort than complex information
formats. A simple format is one that minimizes clutter and best meets
the NLEA requirements that nutrition information should enable the
public to readily observe and comprehend such information. In addition,
a simple format allows consumers to search for accurate nutrition
information with minimum effort, and provides information in a succinct
manner that maximizes understanding (79 FR 11879 at 11948).
    In the preamble to the proposed rule (79 FR 11879 at 11948), we
explained that we were not proposing an extensive reformatting of the
Nutrition Facts label. We further explained that we were proposing to
make changes based on graphic design principles (such as alignment,
consistency, repetition, and contrast), highlight key nutrients and key
information, and remove or modify parts of the label to assist
consumers in maintaining healthy dietary practices. In brief, we
proposed the following changes to the format of the Nutrition Facts
label: (1) Increasing the prominence of calories and serving size; (2)
reversing the order of the ``Serving Size'' declaration and the
``Servings Per Container'' declaration and increasing the prominence of
``Servings Per Container;'' (3) right-justifying the quantitative
amounts of the serving size information; (4) changing the phrase
``Amount Per Serving'' to ``Amount Per __'' with the blank filled in
with the serving size; (5) removing the declaration of ``Calories from
fat;'' (6) modifying the presentation of the ``% DV'' information by
changing its position to the left of the name of the nutrient on
certain labels and separating it from the list of nutrients with a
vertical line; (7) declaring ``Added Sugars'' as an indented listing
directly beneath the listing for ``Sugars''; (8) declaring the
quantitative (or absolute) amounts (in addition to percent DVs) of
mandatory vitamins and minerals and, when declared, voluntary vitamins
and minerals; (9) requiring dual column labeling under certain
conditions; (10) modifying the footnote; (11) requiring that all
nutrients not currently highlighted in bold or extra bold type be
highlighted in a type that is intermediate between bold or extra bold
and regular (i.e., semi-bold) type; (12) adding a horizontal line
directly beneath the ``Nutrition Facts'' heading; and (13) replacing
the listing of ``Total Carbohydrate'' with ``Total Carbs.'' We also
invited comments on other issues related to the Nutrition Facts label
format, including the use of an alternative format design or requiring
the use of a specific font.
    The preamble to the proposed rule also discussed certain
modifications to be applied to other label formats to maintain
consistency with the proposed Nutrition Facts label. These other
modifications would pertain to formats for packages of products that
contain two or more separately packaged foods that are intended to be
eaten individually (e.g., variety packs of cereals and snacks) or that
are used interchangeably for the same type of foods (e.g., round ice
cream containers (Sec.  101.9(d)(13)); formats that apply to
subpopulations (Sec.  101.9(e) and (j)(5)); the simplified format
(Sec.  101.9(f)); the tabular display on packages that do not have
sufficient continuous vertical space (Sec.  101.9(d)(11)(iii)); and the
tabular display (Sec.  101.9(j)(13)(ii)(A)(1)) and linear display
(Sec.  101.9(j)(13)(ii)(A)(2)) for small packages.
    Additionally, in the Federal Register of July 27, 2015 (80 FR
44303), we proposed text for the footnotes to be used on the Nutrition
Facts label and proposed to require the declaration of the percent DV
for added sugars on the Nutrition Facts label. In a separate notice
published in the Federal Register of July 27, 2015 (80 FR 44302), we
reopened the comment period for the proposed rule for inviting public
comments on two consumer studies: One using an experimental design
methodology (the format study) and one using eye-tracking methodology
(the eye-tracking study). The purpose of these studies was to examine
the combined effects of most of the changes outlined in the proposed
rule in their totality; however, both studies also examined certain
individual changes, selected on the basis of priorities and resources
available at that time.

1. General Comments
    To make a determination about the final format for the Nutrition
Facts label, we considered many factors including: Comments we received
about the proposed label format in response to our proposed rule (79 FR
11879), the supplemental proposed rule (80 FR 44303) and the reopening
of the comment period (80 FR 44302); graphic design principles; and
results from consumer research conducted by ourselves and others. This
is similar to the approach we took when determining the original
Nutrition Facts label formats. At that time, our decisions about format
elements drew on information collected from a variety of sources
including focus groups and a professional package design firm, in
addition to label research conducted by FDA and other organizations (57
FR 32060).
    (Comment 478) Several comments stated that neither the results of
our consumer studies nor those submitted by outside parties support the
proposed label changes and that our proposed changes do not improve
consumer understanding of nutrition information on the label over the
current label format. One comment said that the proposed format changes
do not offer ``enhanced value'' to the consumer that would justify a
change from the preexisting label format.
    (Response) The consumer studies that we conducted focused mainly on
comparing the Current, Proposed, and Alternative formats in their
totality. We found that overall consumer preferences, understanding, or
perceptions of product healthfulness (as indicated by the label) were
comparable among the Current, Proposed, and Alternative label formats.
In this final rule, we are making minor changes, such as highlighting
certain specific features and characteristics of the label, to enhance
the information or for other reasons. Our consumer research provided
important information and insights about consumer perceptions,
judgments, and understanding that will be useful in informing our
future consumer education efforts. We acknowledged in our 1993
nutrition labeling final rule that various considerations (i.e., in
addition to consumer research) would bear on the selection of a final
nutrition label format. We previously said that an essential criterion
would be how well a format conveyed information that Congress expected
a nutrition label to provide, such as information that would allow
people to decide whether to buy a product or to understand the relative
significance of the food in the context of the daily diet (58 FR 2079
at 2115). In the consumer studies we conducted to determine the format
for the original Nutrition Facts label, no single format emerged as
being superior in every aspect that was investigated. We subsequently
worked with graphic design experts to develop the new label, drawing on
research that considered not only comprehension, but also legibility
and literacy (Ref. 257).
    (Comment 479) One comment described a study designed to investigate
the extent that consumers are able to quickly notice and understand
label information, as they would during grocery shopping (Ref. 258).
The study compared consumer reactions to FDA's current and proposed
versions of four different Nutrition Facts label formats, each
portraying a different food product, so that a total of eight different
labels were examined. The current and proposed label formats, and the
foods depicted, were: Standard format for single-serve yogurt; tabular
format for frozen vegetables; dual-column label for breakfast cereal
(per serving and with \1/2\ cup skim milk); and a dual-column label for
a multi-serving snack mix package (per serving and per container). The
comment recommended that we not implement the proposed changes in
format for the Nutrition Facts label because, according to the comment,
the study indicated that participants perceived few differences between
the current and proposed label formats.
    (Response) The results of this study are difficult to interpret
because a number of details were not provided. Among other things, the
comment did not adequately describe or explain the demographic
characteristics of the participants, the statistical methods that were
used, how the survey instrument was validated, how the participants
were selected and the study was administered, and why 90 percent
confidence levels were chosen to indicate significant differences
rather than the conventional 95 percent confidence interval. In
addition, the manner in which some questions were worded could have
affected the responses, and the full range of response options was not
presented. Furthermore, the proposed snack mix label appeared to be
inconsistent in how the ``per serving'' and ``per container'' values
were listed for various nutrients. Although the label indicated ``3\1/
2\ servings per container'' for some nutrients (e.g., calories,
carbohydrates, sodium, protein) the amounts that were listed on the
label suggested that there were 4 servings per container, and the
amount of dietary fiber shown on the label indicated there were only
2\1/2\ servings per container. Therefore, we are not able to rely on
the results of this study to inform our decisions regarding Nutrition
Facts label formats.
    (Comment 480) Several comments said that we should not move forward
with the proposed nutrition label format changes without conducting
further consumer research.
    (Response) We disagree with comments suggesting that we should not
finalize this rulemaking until we conduct further consumer research
(see, also, our response to comment 6). We considered consumer research
studies and public comments, and we also relied on graphic design
principles (such as contrast, proximity, alignment, consistency, etc.)
in deciding how the various Nutrition Facts label formats should appear
in finalizing the requirements for the label format.
2. Increasing the Prominence of Calories and Serving Size
    The ability to determine the caloric content of packaged foods is
important for all consumers, especially those who are trying to control
their total caloric intake and manage their weight. Our preexisting
regulations require ``Calories'' to be declared in a type size no
smaller than 8 point (Sec.  101.9(d)(1)(iii)) and highlighted in bold
or extra bold type or other highlighting (Sec.  101.9(d)(1)(iv)). While
calorie information is mandatory on the Nutrition Facts label,
modifying the Nutrition Facts label to give more prominence to calories
may benefit consumers in weight control and maintenance, as noted by
the OWG in its final report entitled ``Calories Count'' (Ref. 127).
    In the preamble to the proposed rule (79 FR 11879 at 11849 and
11948 through 11949), we explained that the OWG recommended, in part,
that we issue an ANPRM to solicit comments on how to give more
prominence to calories on the food label. The OWG suggested possible
changes to the Nutrition Facts label, such as increasing the prominence
of ``Calories'' and ``Serving Size,'' providing a percent DV for
calories, and eliminating the ``Calories from fat'' declaration, which
may detract from the emphasis on total calories. The OWG recommended
that we obtain information on the effectiveness of these options on
consumer understanding and behavior related to calorie intake (Ref.
127). In response to the 2005 ANPRM, several comments supported
increasing the prominence of calories on the Nutrition Facts label.
These comments suggested

various approaches for doing so and pointed out the need for additional
research to fully understand the effects of potential label changes on
consumer understanding and behavior (Ref. 26).
    We considered available data from consumer research and comments
received in response to the ANPRMs and conducted our own research on
food labels. We tentatively concluded that the proposed changes to the
number of calories per serving and the number of servings per container
would result in these declarations serving as an anchor to the
Nutrition Facts label by focusing the reader's attention to this
information and therefore would assist consumers to effectively use
this information in the Nutrition Facts label (Ref. 259). The proposed
rule would revise Sec.  101.9(d) to increase the type size for
``Calories'' and the numeric value for ``Calories'' and also would
require the numeric value for calories be highlighted in bold or extra
bold type to draw attention to this information, emphasize the
importance of calories on the label, and maintain consistency with the
bolded declaration for ``Calories.''
    We also expressed a tentative view that the Supplement Facts label
should have a format similar to the format being proposed for the
Nutrition Facts label with respect to increasing the prominence of
information for calories. We invited comment on whether any changes we
proposed to the Nutrition Facts label also should be required for
certain products with Supplement Facts labels, and if so, under what
conditions and for which dietary supplement products should such
labeling be required.
    (Comment 481) Most comments supported our proposal to increase the
prominence of the calories declaration, indicating that giving more
emphasis to calories on the Nutrition Facts label would likely benefit
consumers in helping them to monitor their caloric intake and make
healthier food choices. Several comments suggested that increasing the
prominence of calories would help focus consumer attention on their
total caloric intake because the information on the label would be more
visible, readily accessible, and hard to ignore. Many comments noted
that the larger, bolder font would draw attention to the calorie
content of the product, encourage consumers to consider this
information when selecting a product or deciding how much to eat, and
help them to grasp the relative significance of a particular food in
the context of their daily diet. Other comments said that increasing
the prominence of calories also would help consumers compare products
when shopping and perhaps encourage them to pay more attention to
labels in general. Several comments pointed out that increasing the
type size and visibility of calories would be especially helpful to
people with impaired vision, including many older adults and diabetics,
and even people with normal vision would benefit if shopping in a dimly
lit grocery store. The comments said that, although information about
other nutrients is important, information on calories is particularly
important because of the prevalence of obesity and the association
between obesity and chronic diseases and disabilities. The comments
agreed that enlarging the calories information and making it bolder
would be an important step, not only in fighting obesity, but also in
controlling diabetes.
    Although most comments acknowledged the importance of calories and
supported increasing the prominence to some extent, many comments
opposed declaring the calorie information in a type size substantially
larger than that of other information on the label. Many comments
expressed concerns that the proposed format overemphasized calories at
the expense of other nutrients declared on the label, and several
comments suggested that the calorie information was
``disproportionately large'' or consumed too much label space. Other
comments included suggestions for improving the overall design and
balance of the label by adjusting the relative type sizes for
``Calories,'' the numeric value for calories, and other nutrition
information on the label, including the ``Nutrition Facts'' heading. A
few comments stated that there was no need to increase the prominence
of calories because the Nutrition Facts label already provides calorie
information and that increasing the prominence may not provide any
additional benefits.
    Several comments said that there is no convincing data that
enlarging the calorie information would help consumers choose healthier
products and that additional consumer research would be essential for
determining a format that improves consumer understanding of calorie
information in the Nutrition Facts label. One comment pointed out that,
although the FDA consumer study cited in the proposed rule failed to
demonstrate that increasing the font size for calories lead to
healthier choices, we nevertheless decided to proceed with our proposal
to increase the prominence of calories on the label. The comment
further stated that, because FDA's own consumer research suggested that
a larger font size does not improve consumer awareness of the calorie
information, we must provide another justification to increase the font
size.
    Many comments also expressed concerns that overemphasizing calories
could have the unintended consequence of suggesting that information
about calories is much more important than information about other
nutrients appearing on the label. For example, some comments said that
the proposed Nutrition Facts label could give the impression that
calorie counting is the most important consideration in managing
health, when, in fact, reducing the risk of chronic diseases and other
health-related conditions goes well beyond caloric intake. Other
comments said that consumers might evaluate and compare food or
beverage products based solely on their caloric content and choose the
option having the fewest calories, without considering the product's
total nutrient profile. Consequently, this could inadvertently result
in consumers avoiding nutrient dense foods as recommended by the
Dietary Guidelines for Americans.
    Several comments expressed concerns that making the calorie
declaration so prominent could affect consumer use and understanding of
other information on the Nutrition Facts label. For example, comments
suggested that, because the ``Amount per __ (serving)'' declaration is
relatively small compared to the proposed ``Calories'' and ``__servings
per container'' declarations, consumers may mistakenly associate the
numeric value for ``Calories'' with the contents of the entire
container, rather than with only one serving. Several comments
emphasized that consumer research is needed to further investigate
formats that would facilitate consumer understanding of this label
information and ensure that the format does not result in consumers
misinterpreting the calories information. One comment suggested that as
part of a consumer test, the ``Amount per __'' (i.e., serving size)
listing and the numeric value for ``Calories'' could be shown in equal
type sizes.
    (Response) We agree that giving more prominence to calories by
increasing the type size and bolding of the ``Calories'' declaration
and the numeric value for ``Calories'' would emphasize the importance
of calories on the Nutrition Facts label.
    We disagree with the comments suggesting it is not necessary to
increase the prominence of the calorie declaration or that the numeric
value for calories should not be larger than the word ``Calories,''
because, as we explain later in this response, emphasizing this

information has potential benefits to consumers who read the label.
However, we agree that the 24 point type size that was proposed for the
numeric value for ``Calories'' on most label formats (excluding small
packages and dual column labels using the tabular format) could be
considered too large and that adequate prominence could still be
achieved by slightly reducing the type size. Therefore, the final rule,
at Sec.  101.9(d)(i)(iii), requires a type size of 22 point for the
numerical value for ``Calories,'' (excluding labels for smaller
packages that have a total surface area available to bear labeling of
40 square inches or less) and a type size of 16 point for the word
``Calories'' on all label formats (excluding labels on smaller
packages, with a total surface area available to bear labeling of 40
square inches or less and all tabular displays) and highlighting both
pieces of information in bold or extra bold type. The requirements for
smaller packages require a type size of no smaller than 14 point for
the numerical value for ``Calories'' for the tabular display for small
packages as shown in Sec.  101.9(j)(13)(ii)(A)(1) and the linear
display as shown in Sec.  101.9(j)(13)(ii)(A)(2), a type size of no
smaller than 10 point for the word ``Calories'' for the tabular
displays as shown in Sec.  101.9(d)(11)(iii) and (e)(6)(ii) and for the
tabular display for small packages as shown in Sec.
101.9(j)(13)(ii)(A)(1) and the linear display as shown in Sec.
101.9(j)(13)(ii)(A)(2). These type sizes will be sufficiently large to
emphasize the importance of calories on the label and draw attention to
this information while decreasing the size to address issues raised in
the comments as well as accommodating size constraints for packages
with a total surface available to bear labeling of 40 square inches or
less (see our response to comment 517).
    We disagree with the comments suggesting that emphasizing calories
would detract from information about other nutrients on the label, or
would result in consumers avoiding nutrient dense foods. No evidence
was submitted in support of these comments, and we are unaware of any
data that emphasizing the calories declaration would encourage
consumers to always choose the lower calorie option, result in poor
nutritional practices, or lead to adverse health consequences. Although
we also are unaware of any consumer studies demonstrating that
increasing the prominence of calories information on the Nutrition
Facts label would either help or hinder consumer use and understanding
of this information, we explained in the preamble to the proposed rule
(79 FR 11879 at 11949) that existing data from studies on warning label
and drug label formats have demonstrated that increasing the prominence
of label information such as warning statements increases consumer
attention to such information. Furthermore, the OWG report suggested
that we consider increasing the font size for calories on the Nutrition
Facts label because of the critical importance of caloric balance in
relation to overweight and obesity (Ref. 127). Similar to graphic
design principles underlying the appearance of warning labels,
increasing the prominence of calories would be expected to draw
consumer attention to this information. The OWG report recommend
mainitaining a healthy body weight and calorie balance is key factor
for managing body weight. The OWG report concluded that obesity is
positively associated with adult morbidity and mortality and has become
a pervasive and urgent public health problem in the United States. The
OWG report also emphasized the medical and health related costs that
result from high rates of overweight and obesity. Moreover the 2015-
2020 DGA does not alter these conclusions and corroborates these
findings. We agree with the OWG report's recommendations and
conclusions particularly emphasizing calories, but we are sensitive to
concerns about over-emphasizing the calories declaration on the label.
An important goal in addressing concerns regarding nutrient density is
education. Nutrition education, especially around the Nutrition Facts
label should be multifactorial and highlight the importance of
calories, but also the other nutrients that can affect health and
chronic disease. Therefore, the final rule requires a smaller type size
for the number of calories on all labels than what we had originally
proposed (i.e., 22 point rather than 24 point for all displays except
those for smaller packages), and even further decreased type size (14)
requirements are permitted for small packages with a total surface area
available to bear labeling of 40 square inches of surface area or less
as described in Sec.  101.9(j)(13)(ii)(A)(1) and (2).
    (Comment 482) A few comments expressed concerns that excessively
focusing on calories and drawing too much attention to the caloric
content of a food product would likely have a negative impact on
individuals who are at risk for an eating disorder, or who are already
struggling with an eating disorder.
    (Response) The comments did not submit data or other evidence to
show that eating disorders could be triggered or exacerbated by
enlarging the ``Calories'' declaration on the Nutrition Facts label. We
are unaware of the existence of such an association and remain
convinced that the potential public health benefits of increasing the
prominence of ``Calories'' would outweigh the risk of a possible
negative impact on individuals struggling with eating disorders.
    (Comment 483) One comment stated that, because dietary supplement
labels often contain a large amount of information on a small label,
increasing the prominence of calories information would likely be
difficult because of a lack of space. The comment stated that an
increased prominence for ``Calories'' on Supplement Facts labels should
be required only if consumption of the dietary supplement would make a
major contribution to daily caloric intake (e.g., 50 or more calories
per serving). However, the comment noted that, in most cases, dietary
supplement products contribute insignificant amounts of calories to the
overall diet.
    (Response) In the preamble to the proposed rule, we invited
comments on whether any of the changes being proposed for the Nutrition
Facts label should also apply to products with Supplement Facts labels
that list calories and/or other macronutrients (79 FR 11879 at 11949).
We did not propose increasing the prominence of calories on labels of
dietary supplement products and did not display the calories
information in a larger and bolder type size in any of the labels
illustrated in the proposed rule in Sec.  101.36(e)(11) and Sec.
101.36(e)(12). We agree with the comment that many dietary supplement
products may contribute a negligible amount of calories. Therefore, the
final rule does not require that information about calories be
displayed in a larger type size or be highlighted in bold or extra bold
type or other highlighting on any Supplement Facts labels.
    (Comment 484) Several comments pointed out that increasing the font
size for ``calories'' and ``serving size'' on the Nutrition Facts label
would affect the size of the percentage juice declaration that
manufacturers are required to make on juice products. Under Sec.
101.30(e)(2), the percent of juice declaration must be in a height not
less than the largest type found on the information panel except that
used for the brand name, product name, logo, universal product code, or
the title for Nutrition Facts. Because information about ``Calories''
is not included among these exceptions, the type size of the juice
declaration would have to be at least as large as the type size of the
numeric value for ``Calories.''

Therefore, according to the comments, increasing the size of the
``Calories'' information would mean increasing the size of the percent
juice declaration significantly. The comments further suggested that we
revise Sec.  101.30(e)(2) to clarify that the percent juice declaration
does not have to be larger than the information about ``Calories'' or
``Serving size.''
    (Response) We inadvertently omitted the corresponding correction to
Sec.  101.30(e)(2) to include ``Serving size,'' ``Calories,'' and the
numerical value for ``Calories'' in the list of exceptions for
declarations in larger type to avoid requiring a type that would be too
large for the declaration of the amount of juice. Therefore, we have
made a technical correction in the final rule and revised Sec.
101.30(e)(2) to state that the title phrase ``Nutrition Facts, the
declaration of ``Serving size,'' ``Calories,'' and the numerical value
for ``Calories'' appearing in the nutrition information must be in
easily legible boldface print or type in distinct contrast to other
printed or graphic matter, in a height not less than the largest type
found on the information panel except that used for the brand name,
product name, logo, or universal product code.
    (Comment 485) One comment said we should not require the calories
information listed on labels of food products intended for infants and
young children to have the same prominence as the calories information
on product labels intended for people 4 or more years of age. The
comment stated that decisions about food choices that are made for
infants and young children should not be based on the number of
calories per portion, but rather on the overall nutrient profile of the
food. The comment explained that, by relying too much on a food's
caloric content, parents may inadvertently restrict healthful foods or
make inappropriate food choices for their young children and infants.
The comment also said that, according to nutrition experts, children in
this age range should be encouraged to self-regulate caloric intake and
that parents and caregivers should feed children in response to the
child's hunger and fullness cues rather than on the basis of a
preconceived number of calories they believe the child should consume.
    (Response) We agree with the comment that food choices for infants
through 12 months of age and children 1 through 3 years of age should
focus primarily on a food's overall nutrient profile rather than on the
number of calories per serving (Refs. 260-261). The IOM report
advocated feeding children in response to their hunger and fullness
cues, rather than providing foods for children based on the number of
calories in a serving of the product. However, the IOM report also
emphasized the importance of parents establishing healthful eating
habits for their children early in life. The IOM report stated that
children who consume a diet that restricts energy-dense foods high in
sugar, fat, and salt, but that is rich in nutrient-dense foods, are
less likely to become overweight or obese. Thus, although the IOM
report did not explicitly recommend restricting children's foods based
on calorie content, it suggested that parents and caregivers should at
least be aware of the amount of calories (and other nutrients) in the
foods they give their children, especially those over 2 years of age,
in order to begin establishing good eating habits.
    The comment did not provide evidence that parents would restrict
foods or make inappropriate food choices for their young children and
infants based solely on the food's caloric content. We acknowledge that
parents and caregivers would likely consider a variety of factors when
making decisions about what to feed their young children and that
increasing the prominence of calories information on the labels of
foods intended for young children does not necessarily mean that
parents would restrict these foods. Therefore, we do not consider it
necessary for the calories information on products for infants through
12 months of age and children 1 through 3 years of age to differ from
that required on Nutrition Facts label formats for foods intended for
individuals 4 years of age and older. To maintain consistency in label
formats, the final rule requires that the calories information on
labels of foods intended for infants through 12 months of age and
children 1 through 3 years of age be displayed prominently, as
indicated in the label mockups shown in Sec.  101.9(j)(5)(i) and (ii).
3. Changing the Order of the ``Serving Size'' and ``Servings Per
Container'' Declarations and Increasing the Prominence of ``Servings
Per Container''
    Our preexisting regulations specify that information on serving
size, consisting of a statement of the serving size (Sec.
101.9(d)(3)(i)) and the number of servings per container (Sec.
101.9(d)(3)(ii)), must immediately follow the identifying heading of
``Nutrition Facts.'' In addition, ``Serving Size'' and ``Servings Per
Container'' must be in a type size no smaller than 8 point (Sec.
101.9(d)(1)(iii)).
    In the preamble to the proposed rule (79 FR 11879 at 11949), we
explained that, with respect to the Nutrition Facts label, an important
consumer need is to identify the number of servings per container of a
packaged food. Therefore, we proposed placing ``Servings Per
Container'' above ``Serving Size'' to help consumers find the number of
servings per container with less effort than is now needed. We also
proposed that listing ``__ servings per container'' with the blank
filled in with the actual number of servings directly beneath the
``Nutrition Facts'' heading, and highlighting it in bold or extra bold
type, would help increase awareness that the information presented in
the Nutrition Facts label does not refer to the contents of the entire
package when the label indicates that there is more than one serving
per container. We explained that listing ``Serving size'' in the same
proximity to where the actual nutrient information is located on the
label (rather than directly beneath the Nutrition Facts heading as in
our preexisting regulations, Sec.  101.9(d)(3)) would help consumers
understand that this nutrient information pertains to the particular
serving size that is declared. (According to the graphic design
principle of proximity, items that are positioned closer together are
perceived to be more closely related (Ref. 262)). Thus, we tentatively
concluded that reversing the order of the declarations of ``Servings
Per Container'' and ``Serving Size'' would help consumers more readily
observe and comprehend the nutrition information appearing in the
Nutrition Facts label, allow consumers to search for information with a
minimum of effort, and assist consumers in their food purchasing
decisions and in maintaining healthy dietary practices. We proposed to
redesignate Sec.  101.9(d)(3)(i) as Sec.  101.9(d)(3)(ii), redesignate
Sec.  101.9(d)(3)(ii) as Sec.  101.9(d)(3)(i), and to make changes in
how the serving size information is capitalized on the label so that no
capital letters are used, except for the first letter in ``Serving
size.'' We also proposed to require that the declaration of
``__servings per container'' (with the blank filled in with the actual
number of servings) be highlighted in bold or extra bold type and be in
a type size no smaller than 11 point (except for the tabular and linear
displays for small packages) (proposed Sec.  101.9(d)(3)(i)), and that
the information for ``Serving size'' be in a type size no smaller than
8 point (except for the linear display for small packages) (proposed
Sec.  101.9(d)(3)(ii)).
    We did not propose similar changes for serving size information for
dietary supplements. In the preamble to the

proposed rule (79 FR 11879 at 11950), we said that, when taking dietary
supplements, consumers need to know how much of the product to take
(e.g., 1 capsule, 2 tablets, 1 packet) and that this information, which
is currently provided in the ``Serving Size'' line of the Supplement
Facts label, is more important for the consumer to know than the number
of servings (e.g., 100 tablets) contained in the package.
    (Comment 486) Many comments supported changing the order of the
``Serving Size'' and ``Servings Per Container'' declarations because
the comments felt that this change would make the label easier to read
and understand. The comments said consumers would be better able to
compare products when shopping and make better buying decisions, which
could ultimately lead to improved health for themselves and their
families. Other comments suggested that the proposed changes could help
consumers understand that nutrition information on the label is based
on the serving size, which could increase awareness of the amount of
food actually being consumed. In addition, comments said that the
proposed change could help consumers monitor their caloric and nutrient
intakes, compare products more easily, eat more moderate portions, and
more easily grasp the relative significance of a food product in the
context of their daily diet.
    Other comments said that reversing the order of serving size and
the number of servings per container, especially in combination with
increasing the prominence of information about calories, would make the
relationship between the ``Calories'' and ``Serving size'' declarations
clearer, lead to a better understanding of the calories information,
and improve the flow of the label.
    In contrast, several comments opposed changing the order and said
we should continue to list ``Serving size'' above ``__ servings per
container.'' The comments suggested that information about a product's
serving size was more important than the number of servings per
container because the label's information is based on the serving size
declaration. Many comments that opposed reversing the order of serving
size and servings per container expressed a preference for us to
increase the prominence of serving size instead. The comments said that
putting the ``Serving size'' declaration in bold print and increasing
its type size would emphasize its importance and increase awareness
that the nutrition information on the label is based on the serving
size.
    (Response) As we explained in the preamble to the proposed rule (79
FR 11879 at 11949), reversing the order in which ``Serving Size'' and
``Servings Per Container'' are listed would place the serving size
information in closer proximity to where the actual nutrient
information is located on the Nutrition Facts label. According to
graphic design principles (i.e., the principle of ``proximity''), this
would increase the perception that the serving size is closely related
to the nutrition information that follows directly below it, and thus
provide necessary context for helping consumers understand that this
nutrition information pertains to the particular serving size that is
declared. If the order of the ``Serving Size'' and ``Servings Per
Container'' declarations was preserved as in our preexisting
regulations and as preferred by some comments, the relationship between
the nutrition information and the serving size might be less clear.
Although some comments suggested that we put the serving size
declaration in bold print rather than shift its position, it is
unlikely that bold print, alone, would provide the necessary context
for helping consumers to understand the association between serving
size and the nutrient information because these pieces of information
in the preexisting regulation would be lacking in proximity, and the
contrast between the ``Serving size'' declaration and the ``Nutrition
Facts'' heading directly above it would be reduced if both were in a
bold or extra bold font. We address the comments concerns regarding
increased emphasis of ``serving size'' instead of ``servings per
container'' in our response to comment 488.
    Therefore, the final rule, at Sec.  101.9(d)(3)(ii), requires that
``serving size'' be placed below ``_Servings per container.'' The final
rule also requires the information to be highlighted in bold or extra
bold and be in a type size no smaller than 10 point, except the type
size must not be smaller than 8 point for the information for small
packages as shown in Sec.  101.9(j)(13)(ii)(A)(1) and (2). Displaying
both pieces of information related to serving size adjacent to each
other should help consumers understand how the serving size relates to
the nutrition information on the label and use the label to plan and
maintain healthy dietary practices. It is important for consumers to
understand the serving size and realize how it relates to the rest of
the label's nutrition information.
    (Comment 487) Many comments supported inserting the actual number
of servings at the beginning of ``servings per container'' statement
because this could help consumers identify more readily the number of
servings in a package and help consumers decide how many people a
particular food item could serve or feed. The comments said that
consumers would have a better idea of the total number of calories in
the package as well as the number of calories they would actually
consume if they eat the entire contents of a multi-serving package.
    (Response) We agree with the comments, and so the final rule, at
Sec.  101.9(d)(3)(i), requires the actual number of servings at the
beginning of the ``servings per container'' statement.
    (Comment 488) Many comments agreed that increasing the prominence
and visibility of ``servings per container'' would enable consumers to
notice and use this information. The comments further stated that
individuals who did not previously or regularly use the label might
begin to do so and that increasing the prominence of the ``servings per
container'' declaration would not only be ``eye catching'' and ``hard
to ignore,'' but also would be helpful to people with poor vision or
those who shop in dimly lit grocery stores.
    Some comments suggested increasing the size and prominence of the
``Serving Size'' declaration, as well as that of ``servings per
container.'' One comment acknowledged that one intention of the
proposed rule is to help consumers more easily recognize multi-serving
packages, but said there was no valid justification for making the ``__
servings per container'' information more prominent than the ``Serving
size'' declaration. Another comment suggested that increasing the
prominence of both calories and serving size could be especially
important on labels of some sugar-sweetened beverages, particularly on
products that may contain more than one serving, but are often consumed
during one eating occasion.
    Several other comments opposed increasing the prominence of
``servings per container'' because, according to the comments,
``serving size'' is the more important piece of information. The
comments would emphasize ``Serving size'' in a larger and bolder font.
Many comments said that making the serving size information easier for
consumers to see and understand was important for properly interpreting
the calorie information (in addition to increasing the prominence of
``Calories'') and is also ``what consumers are used to'' seeing.
Several comments said that the proposed font size of the ``__ servings
per container'' statement was so large

that consumers might mistakenly think that the number of calories
listed in the ``Calories'' declaration on the label pertained to the
entire package; i.e., to all of the servings that appear in the ``__''
space. Another comment suggested reducing the type size for ``__
servings per container'' to a size smaller than the ``Amount per __''
statement. One comment suggested that the relative differences in type
sizes in the listings for the number of servings per container, the
amount per serving, and the numeric value for ``Calories'' could result
in consumers mistakenly associating the number of calories with the
total package because the ``Amount per __'' is relatively small
compared to the other declarations. One comment said that giving
increased prominence to ``Serving size'' would be a reasonable way to
implement the recommendations of the OWG's Calories Count report and
would be consistent with existing research data suggesting a lack of
attention to this listing.
    (Response) The comments reflect the need to consider how much
emphasis to provide for the ``Serving size'' declaration compared to
the ``__ servings per container'' declaration. We agree with the
comments that the serving size information was not prominent enough in
our proposal and that consumers could potentially associate the calorie
and nutrition information on the label with the ``servings per
container'' declaration since it was more prominent compared to the
serving size declaration. We also agree that the ``servings per
container'' declaration should be more prominent and visible than on
the preexisting label so consumers will be able to use this information
if they consume all or a larger portion of a multi-serving container.
Increasing the prominence of the ``Serving size'' information by
bolding and slightly increasing the font size will emphasize the
importance of the information and, along with its placement, would
assist consumers in better understanding how to use the Nutrition Facts
label to interpret accurately the calories and nutrient information on
the label that is directly below the ``Serving size'' declaration. To
provide prominence to ``Serving size,'' however, we need to reduce the
prominence of ``servings per container.'' According to graphic design
principles (e.g., contrast), alternating a larger and bolder type style
with a smaller, regular type style on successive lines of the Nutrition
Facts label will provide maximum visibility and optimal highlighting to
the information that we wish to emphasize on the label (Ref. 262).
Contrast is a graphic design principle that uses opposing elements
(such as bolding) to differentiate objects in the same field of view,
or to intensify the effect between objects that would otherwise look
similar (Ref. 263). Thus, we are providing contrast in the first three
lines of the Nutrition Facts label in the final rule (i.e., the
Nutrition Facts heading, the ``__ servings per container'' declaration,
and the ``Serving size'' declaration) by alternating the use of bold
font with non-bold font for this information. We also realize that
enlarging the ``__ servings per container'' declaration through bolding
may pose space challenges if the word ``about'' is used in this
statement, which is allowed under Sec.  101.9(b)(8)(i).
    Therefore, the final rule requires that the ``Serving size''
declaration, and the quantitative information associated with this
declaration, be listed in a type size no smaller than 10 point (except
on labels of smaller packages with a total surface area available to
bear labeling of 40 square inches or less and all tabular formats where
a type size of 9 point type is permissible due to space constraints)
and be highlighted in bold or extra bold type. Additionally, if a
product has a ``Serving size'' declaration with too many characters to
fit in the provided space allocated for the ``Serving
size''declaration, then a type size of 8 point is permissible for any
size package (Sec.  101.9(d)(3)(ii)). To reduce the prominence of the
``__ servings per container'' declaration, we are requiring that ``__
servings per container'' be listed in a regular type in a type size no
smaller than 10 point (except on labels of smaller packages with a
total surface area available to bear labeling of 40 square inches or
less (Sec.  101.9(j)(13)(ii)(A)(1) and (2)) where a type size of 9
point is permissible due to space constraints) directly beneath the
Nutrition Facts heading, followed directly below by the ``Serving
size'' declaration in bolder font.
    (Comment 489) One comment referred to a study suggesting that many
consumers do not look at serving size information, but otherwise do
refer to the Nutrition Facts label and ingredients list, as evidence
that the serving size declaration needs to be made more prominent.
Other comments suggested that we should more closely review previous
consumer research studies or conduct additional studies to determine
the effects of displaying ``Serving size'' and ``servings per
container'' information more prominently, and determine the potential
implications of increasing the prominence and changing the location of
the ``__ servings per container'' information on the Nutrition Facts
label.
    (Response) We disagree with the comment suggesting that many
consumers do not look at serving size information, but otherwise do
refer to the Nutrition Facts label and ingredients list. The comment
apparently misinterpreted a published abstract (Ref. 264) of a study
that investigated consumer perceptions and use of the serving size
information, ingredient list, health claim information, and the
Nutrition Facts label in general, particularly with regards to the
extent that each of these impact purchasing decisions. The study, which
drew on data from the 2005-2006 and 2007-2008 NHANES, was recently
published in its entirety (Ref. 265). In contrast to what the comment
said, the abstract stated that the study participants were more likely
to use the Nutrition Facts label (in general) and the ingredient list
in particular than information about serving size and health claims. In
addition, according to data from the NHANES 2009-2010 cycle,
approximately 64 percent of respondents (16+ years of age) reported at
least ``sometimes'' using the serving size information on the food
label when deciding to buy a food product, and 31 percent of the
respondents reported that they used the serving size information either
``always'' or ``most of the time'' (Ref. 266).
    As for the comments suggesting that we need to evaluate consumer
research and conduct further research in regards to switching the order
and increasing the prominence of ``Serving size'' and ``servings per
container,'' we address these issues in our responses to comments 478
and 480. We also note that we are finalizing the requirement to
include, directly below ``Nutrition Facts,'' the ``servings per
container'' declaration followed by the ``Serving size'' declaration.
As we explain in our response to comment 488, the location of ``Serving
size'' to where ``servings per container'' was formerly located places
it in closer proximity to the nutrient information that pertains to the
serving size of the product.
    (Comment 490) One comment said that ``__ servings per container''
is irrelevant information because the nutrition information on the
label refers to the amount of nutrients and calories in a single
serving. The comment would have the Nutrition Facts label emphasize the
size of a serving (i.e., the serving size) rather than the number of
servings that are in the container.
    (Response) The declaration of ``__ servings per container''
provides important information to the consumer

about how the information on calories and nutrients for one serving of
food relate to the entire package of food. Consumers may consume more
than one serving and need to know how the portions consumed relate to
their total daily dietary intake. Therefore, we decline to revise the
rule as suggested by the comment. However, we have revised Sec.
101.9(d)(3) to clarify that both the ``__ servings per container'' and
``Serving size'' declarations are components of the serving size
information required on the label.
    (Comment 491) Other comments opposed increasing the prominence of
``__ servings per container'' because, in combination with other
proposed changes, it would increase the space requirements for the
Nutrition Facts label. One comment said that, because of space
limitations on the label, we should not require the words ``per
container'' to be included in the ``__ servings per container''
statement. The comment further said that ``per container'' is not
needed for consumers to identify the number of servings in the package.
The comment cited data from an online consumer research study (Ref.
267) to assert that 98 percent of the study participants correctly
identified the number of servings per package and the serving size when
the label did not include the words ``per container,'' while 92 percent