processed vegetables and fruits may contain other ingredients, such as
added sugars or sodium, that can affect their nutrient content; thus,
it is necessary to include nutrient-to-limit criteria for such foods.
For any type of processed fruits and vegetables where the fruits and
vegetables remain primarily unchanged, such as plain frozen fruits and
vegetables, those products would generally qualify for use of the claim
under the criteria for individual foods, as they do not exceed the
nutrient criteria and would meet the food group equivalent requirement.
As described in section V.B.3.b (``Individual foods''), we are
proposing that individual fruit and vegetable products (including
processed fruits and vegetables, but which excludes raw, whole fruits
or vegetables) may bear the nutrient content claim ``healthy'' only
when they meet certain additional food group equivalent and nutrient-
to-limit requirements.
b. Individual Foods
    Individual foods are foods that are comprised entirely or almost
entirely of one food group (excluding raw, whole fruits and vegetables,
as explained above). Foods that contain a meaningful amount (at least
half a food group equivalent) of more than one food group would be
considered a combination food and are discussed in section VI.B.3.c
(``Combination foods''). In many cases, an individual food will be
comprised of only one food group; for example, individual foods include
oatmeal (which is comprised of only whole grain), dried fruit (fruit),
or low-fat plain yogurt (dairy). In some cases, individual foods
include ingredients from multiple food groups, but one food group would
still predominate, and the product may only contain a minimal amount of
another food group; for example, cinnamon raisin oatmeal (primarily
whole grain) and yogurt with granola topping (primarily dairy) would
both be individual foods. To bear the nutrient content claim
``healthy,'' individual foods would have to meet the criteria outlined
in Sec.  101.65(d)(3)(iii), which includes requirements for food group
equivalents and for nutrients to limit.
    For the purposes of this rule, individual foods have been separated
into the six food groups described in the Dietary Guidelines, 2020-
2025: vegetables, fruits, grains, dairy, proteins (including all
subgroups), as well as oils. As in the Dietary Guidelines, 2020-2025,
individual foods fit into food groups based on how they are consumed,
even if this is different from their botanical classification. We are
proposing that individual products would need to contain a specified
minimum food group equivalent per RACC (e.g., \1/2\ cup of fruit, \3/4\
cup of dairy) to be labeled ``healthy.'' Individual products would also
need to adhere to criteria for nutrients to limit per RACC for
saturated fat, sodium, and added sugars. The food group equivalents and
the nutrients-to-limit benchmarks are adjusted for each food group. The
specific food group equivalent criteria, along with the criteria for
nutrients to limit, are discussed further in the following sections.
(1) Vegetable Products
    As discussed previously, healthy dietary patterns include
vegetables from all vegetable subgroups: dark green, red and orange,
beans, peas, and lentils, starchy, and other. The nutrient content of
beans, peas, and lentils is similar to foods in both the protein foods
group and in the vegetable group and may be counted under either food
group. Vegetables contribute many nutrients to the diet including
dietary fiber, potassium, and iron, among others, and nutrient
contributions can vary across the subgroups (Ref. 21). The Dietary
Guidelines, 2020-2025 notes that each of the food groups and their
subgroups provides an array of nutrients and that eating an appropriate
mix of foods from the food groups and subgroups is important to promote
health at each life stage (Ref. 1). Therefore, consumption of a variety
of vegetables from all vegetable subgroups in nutrient-dense forms is
encouraged. The vegetables food group can include fresh, frozen,
canned, and dried forms of vegetables, as well as 100% vegetable juice.
FDA considers concentrated vegetable purees and vegetable pastes to be
vegetables for the purpose of calculating food group equivalents since
these products are essentially whole vegetables that have been
processed to change the physical form of the vegetable to remove
moisture. We tentatively do not consider vegetable powders to be
vegetables for the purpose of calculating food group equivalents. These
products could be produced or used in a way that modifies the whole
vegetable to an extent that removes some essential characteristics that
are beneficial when consuming the whole vegetable, which could impact
nutrient content. However, we recognize that food manufacturers
continue to innovate in this space. We welcome comment on whether we
should consider certain vegetable powders to be vegetables for the
purpose of calculating food group equivalents. In particular, we are
interested in any comments or data regarding whether vegetable powders
have similar or different nutrient content, or similar or different
roles in a healthy dietary pattern, compared to whole vegetables.
    The recommended amount of vegetables in the Healthy U.S.-Style
Dietary Pattern at the 2,000-calorie level is 2\1/2\ c-eq of vegetables
per day. As described in section VI.B.3.b (``Individual foods''), for
most food groups and subgroups, we determined the ``food group
equivalent'' by dividing the daily recommended amount by four (for four
eating occasions per day). For vegetables, we revised the amount
derived from the baseline calculation slightly (from \3/4\ c-eq down to
\1/2\ c-eq) for two reasons. First, vegetables are significantly
underconsumed according to the Dietary Guidelines, 2020-2025. Second,
we found that a \1/2\ c-eq aligned better with the RACCs for most
vegetable products as set out in FDA's NFL final rule. Thus, we are
proposing that to bear the nutrient content claim ``healthy,'' a
vegetable product must contain at least \1/2\ c-eq vegetables per RACC.
    We are proposing that the added sugars content for vegetable
products must be no greater than 0 percent DV per RACC. This is lower
than some other food groups because vegetable products generally do not
contain added sugars. We are proposing that vegetable products be
subject to the baseline values for sodium and saturated fat; i.e., the
sodium content must be no greater than 10 percent DV per RACC and the
saturated fat content must be no greater than 5 percent DV per RACC, as
many vegetable products in the food supply contain some sodium and
added fats for taste, processing, and preservation. We are seeking
comment on this proposal.

                                Table 3--Vegetable Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
                                          Food group equivalent     Added sugar                    Saturated fat
                                                 minimum               limit       Sodium limit        limit
----------------------------------------------------------------------------------------------------------------
Vegetable product.....................  \1/2\ cup-equivalent....           0% DV          10% DV           5% DV
----------------------------------------------------------------------------------------------------------------

(2) Fruit Products
    Healthy dietary patterns include fruits, especially whole fruits.
Fruits contribute many nutrients to the diet, including dietary fiber,
potassium, and vitamin C (Ref. 21). Fruits can be consumed in fresh,
frozen, canned, and dried forms. FDA considers concentrated fruit
purees and fruit pastes to be fruit for the purpose of calculating food
group equivalents since these products are essentially whole fruits
that have been processed to change the physical form of the fruit to
remove moisture. The fruits food group also includes 100 percent fruit
juice. We tentatively do not consider fruit powders to be fruits for
the purpose of calculating food group equivalents. These products could
be produced or used in a way that modifies the whole fruit to an extent
that removes some essential characteristics that are beneficial when
consuming the whole fruit, which could impact nutrient content.
However, we recognize that food manufacturers continue to innovate in
this space. We welcome comment on whether we should consider certain
fruit powders to be fruits for the purpose of calculating food group
equivalents. In particular, we are interested in any comments or data
regarding whether fruit powders have similar or different nutrient
content, or similar or different roles in a healthy dietary pattern,
compared to whole fruits.
    The recommended amount of fruits in the Healthy U.S.-Style Dietary
Pattern at the 2,000-calorie level is 2 c-eq per day. Applying the
baseline calculation discussed in section VI.B.3.b (``Individual
foods''), we propose that an individual fruit product must contain at
least \1/2\ c-eq of fruit per RACC to bear the ``healthy'' claim. We
are seeking comment on this proposal.
    As with vegetable products, we are proposing to lower the baseline
added sugars limit to 0 percent DV per RACC for fruit products. While
small amounts of added sugars can be part of a healthy dietary
pattern--the Dietary Guidelines, 2020-2025 recommendations allow for a
certain allotment of added sugars per day--we do not want the
``healthy'' claim to encourage addition of added sugars in otherwise
nutrient-dense fruit products, which are generally already naturally
sweet. Moreover, while we recognize that some fruit juices and canned
fruits contain added sugars, the Dietary Guidelines, 2020-2025
specifically recommends that juices should be 100 percent juice,
without added sugars, and that individuals should choose canned fruits
that are canned with 100 percent juice or options lowest in added
sugars. Thus, to qualify for the ``healthy'' claim, we propose to allow
no added sugars in fruit products (which includes products with 100
percent fruit juice). For the fruit category, we find that there are no
special circumstances that require deviation from the baseline levels
for sodium and saturated fat, so we are proposing the baseline value
for sodium of 10 percent DV per RACC and 5 percent DV saturated fat per
RACC for fruit products.

                                  Table 4--Fruit Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
                                          Food group equivalent     Added sugar                    Saturated fat
                                                 minimum               limit       Sodium limit        limit
----------------------------------------------------------------------------------------------------------------
Fruit product.........................  \1/2\ cup-equivalent....           0% DV          10% DV           5% DV
----------------------------------------------------------------------------------------------------------------

(3) Grain Products
    Healthy dietary patterns include whole grains and limit the intake
of refined grains. Whole grains contain the entire kernel, including
the endosperm, bran, and germ. Refined grains differ from whole grains
in that the grains have been processed to remove the bran and germ,
which removes important nutrients. Whole grains provide nutrients such
as dietary fiber, iron, zinc, manganese, folate, magnesium, copper,
thiamin, niacin, vitamin B6, phosphorus, selenium, riboflavin, and
vitamin A (Ref. 21). Whole grains can be consumed as single foods
(e.g., brown rice, oats), or as products that include grains as an
ingredient (e.g., breads, cereals, crackers, and pasta).
    The recommended amount of grains in the Healthy U.S.-Style Dietary
Pattern at the 2,000-calorie level is 6 oz-eq per day. At least half of
this amount should be whole grains (i.e., at least 3 oz-eq). Whole
grains, when prepared with little or no added sugars, sodium, and
saturated fat, are typically more nutrient-dense foods and the Dietary
Guidelines, 2020-2025 indicates that whole grains are underconsumed
while refined grains are overconsumed. Thus, we propose that grain
products must contain whole grains to bear the ``healthy'' claim.
Applying the baseline calculation for food group equivalent as
explained in section VI.A (``Overview of Approach''), we are proposing
that a whole grain equivalent is \3/4\ oz-eq. This means that to bear
the ``healthy'' claim, an individual grain product must contain at
least \3/4\ oz-eq whole grains per RACC. We seek comment on this
approach.
    For the grains category, we find that there are no special
circumstances that require deviation from the baseline levels, so we
are proposing the baseline value for all of the nutrients to limit: the
added sugars content must be no greater than 5 percent DV per RACC, the
sodium content must be no greater than 10 percent DV per RACC, and the
saturated fat content must be no greater than 5 percent DV per RACC.

                                  Table 5--Grain Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
                                          Food group equivalent     Added sugar                    Saturated fat
                                                 minimum               limit       Sodium limit        limit
----------------------------------------------------------------------------------------------------------------
Grain product.........................  \3/4\ ounce-equivalent             5% DV          10% DV           5% DV
                                         wholegrain.
----------------------------------------------------------------------------------------------------------------

(4) Dairy Products
    Dairy in healthy dietary patterns includes fat-free (skim) and low-
fat (1 percent) milk, yogurt, cheese, and fortified soy beverages or
soy yogurt alternatives. Nutrients provided by foods in the dairy food
group include calcium, phosphorus, vitamin A, vitamin D, riboflavin,
vitamin B12, protein, potassium, zinc, choline, magnesium, and selenium
(Ref. 21). The Dietary Guidelines, 2020-2025 states that about 90
percent of the U.S. population does not meet dairy recommendations and
most individuals would benefit by increasing intake of dairy in fat-
free or low-fat forms, whether from milk, yogurt, and cheese, lactose-
free versions, or from fortified soy beverages or soy yogurt
alternatives. Fat-free and low-fat dairy products provide the same
nutrients but less saturated fat (and thus, fewer calories) than higher
fat options, such as 2 percent and whole milk and regular cheese.
    The Dietary Guidelines, 2020-2025 includes fortified soy beverages
and soy yogurt alternatives in the dairy group because they have
similar nutrient compositions and use in meals (Refs. 1, 22). Other
products and beverages made from plants (e.g., almond, rice, coconut,
oat, and hemp products) are not included in the dairy group because
their overall nutritional content is not similar to dairy milk, yogurt,
and fortified soy beverages and soy yogurt alternatives (e.g., lower
levels of calcium, vitamin D, and other nutrients). However, it is
possible that these types of products may eventually be formulated or
fortified to have nutritional profiles that are more similar to the
nutritional profile of the dairy food group. Although FDA does not
generally support fortification as a method to qualify for a
``healthy'' claim, fortification of soy beverage and yogurt
alternatives and other plant-based beverage and yogurt alternatives are
a special circumstance. As discussed earlier in this rule, around 90
percent of the U.S. population does not meet the dairy recommendations
even though dairy is a core element of a healthy dietary pattern. The
Dietary Guidelines, 2020-2025 highlights the importance of increasing
overall intake of dairy foods while acknowledging that some individuals
are in need of alternative dairy options. For example, lactose-free and
low-lactose options are suggested for those with issues in digesting
traditional dairy products. For individuals with restrictions on
consumption of traditional dairy foods (e.g., medical restrictions or
religious preferences), fortified soy beverages and soy yogurt
alternatives are included in the dairy group. Including fortified
plant-based dairy alternatives among the food options in the dairy
group can assist consumers in increasing their dairy intake and meeting
the dairy intake recommendations. Therefore, to support the
availability of non-dairy choices for individuals who are lactose
intolerant or allergic to dairy or choose not to consume dairy, plant-
based milk alternatives and plant-based yogurt alternatives whose
overall nutritional content is similar to dairy (e.g., provide similar
amounts of protein, calcium, potassium, magnesium, vitamin D, and
vitamin A) (Ref. 21) and are used as alternatives to milk and yogurt
would be evaluated against the dairy criteria for the purposes of the
``healthy'' nutrient content claim.
    The recommended amount of dairy in the Healthy U.S.-Style Dietary
Pattern at the 2,000-calorie level is 3 c-eq per day. Based on our
baseline calculations, we are proposing that a food group equivalent of
dairy equal \3/4\ c-eq. This means that an individual dairy food must
contain at least \3/4\ c-eq of dairy per RACC to bear the ``healthy''
nutrient content claim.
    We are proposing to increase the saturated fat limit for dairy
products from the baseline level. Under the baseline saturated fat
limit of 5 percent DV, low-fat dairy (e.g., 1 percent milk) would not
meet the criteria for bearing the ``healthy'' claim (Ref. 20). Forms of
dairy that are more nutrient dense (i.e., fat-free and low-fat dairy
products) provide important nutrients with less saturated fat than 2
percent or whole-fat dairy. As stated above, the Dietary Guidelines,
2020-2025 therefore recommends increasing intake of dairy products in
fat-free and low-fat forms, to replace intake of 2 percent or whole
dairy. We are proposing to revise the saturated fat limit for dairy to
<=10 percent DV of saturated fat per RACC to allow low-fat dairy to
bear the ``healthy'' claim provided the other proposed criteria are
met.
    We are also proposing that dairy products (e.g., sweetened yogurt
and cheese) must meet the baseline limit for added sugars of 5 percent
DV per RACC and for sodium of 10 percent DV per RACC. We find that
there are no special circumstances that require deviation from the
baseline levels for added sugars and sodium. Additionally, the sodium
level of 10 percent is appropriate because many dairy products,
especially cheeses, can be expected to contain some sodium due to
processing and preservation methods. We seek comment on this approach.

                                  Table 6--Dairy Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
                                          Food group equivalent     Added sugar                    Saturated fat
                                                 minimum               limit       Sodium limit        limit
----------------------------------------------------------------------------------------------------------------
Dairy product.........................  \3/4\ cup-equivalent....           5% DV          10% DV          10% DV
----------------------------------------------------------------------------------------------------------------

(5) Protein Food Products
    Healthy dietary patterns include a variety of protein foods in
nutrient-dense forms, including protein foods from both plant and
animal sources. Plant sources of proteins can include nuts, seeds,
beans, peas, and lentils, and soy products. The nutrient content of
beans, peas, and lentils is similar to foods in both the protein foods
group and in the vegetable group and may be counted under either
category. Animal sources can include seafood, meat, poultry, and eggs.
Along with protein, foods in this group contribute important nutrients
such as niacin, vitamin B12, vitamin B6, riboflavin, selenium,

choline, phosphorus, zinc, copper, vitamin D, and vitamin E and iron
(Ref. 21). Additionally, seafood can provide polyunsaturated omega-3
fatty acids (eicosapentaenoic acid and docosahexaenoic acid). While
Americans' overall intakes of protein foods are close to the
recommended amounts, many Americans do not meet the intake
recommendations for specific protein subgroups. Therefore, the Dietary
Guidelines, 2020-2025 recommends shifts within the protein group to add
variety to the intake of protein foods (Ref.1).
    Since specific considerations for different foods within the
protein foods group may vary, we are proposing to divide protein foods
into the following subgroups: (1) game meats; (2) seafood; (3) eggs;
(4) beans, peas, lentils, and soy products; and (5) nuts and seeds.
These subgroups are slightly different from the subgroups in the
Dietary Guidelines, 2020-2025 because they are based on what we
determined as the specific needs for variation in food group
equivalents and the nutrients to limit, as discussed below. In
addition, our subgroups do not include the animal sources of protein
whose labeling is regulated by USDA's Food Safety and Inspection
Service (e.g., meat and poultry products, egg products, and catfish).
    The recommendation for protein foods in the Healthy U.S.-Style
Dietary Pattern at the 2,000-calorie level is 5\1/2\ ounce-equivalents
per day. As with all of the food groups, we calculated the food group
equivalent using the method described in section VI.B.3.b (``Individual
foods''). One fourth of 5\1/2\ oz equivalents is 1\3/8\ oz equivalents
and based on standard rounding rules, we propose that the food group
equivalent criteria for game meat is at least 1\1/2\ oz equivalent. We
propose rounding down to 1 oz-eq for all other protein subgroups. For
beans, peas, lentils, soy products, and seafood, we propose rounding
down to increase the number of products containing these subgroups that
would be eligible to bear the claim, and therefore encourage
consumption of them. This is consistent with the Dietary Guidelines,
2020-2025 strategy to increase variety of choices made by replacing
some meats, poultry, and egg intake with seafood, beans, peas, and
lentils, nuts, seeds, and soy products. Game meat, which is part of the
traditional diets of certain populations, falls within the meat,
poultry, and egg protein subgroup in the Dietary Guidelines. However,
we acknowledge that intake levels of game meat may not be at similar
levels as other meat, poultry and egg products. We also propose
rounding down to at least 1 oz-eq for eggs as this is equal to one egg,
a common serving size. We welcome comments on the values set for the
food group equivalents for the protein subgroups.
    For all of the protein food subgroups, we propose that the food
contain no more than 0 percent DV of added sugars per RACC because most
protein food products generally do not contain added sugars. We are
also proposing that all protein products must meet the baseline limit
for sodium of 10 percent DV per RACC as many protein products in the
food supply contain some sodium for taste, processing, and/or
preservation.
    Because protein foods are a diverse group of foods containing
varying amounts of saturated fat, we are proposing different saturated
fat limits for some subgroups. For game meats, seafood, and eggs, we
are proposing to increase the limit for saturated fat to 10 percent DV
because using the baseline saturated fat limit would prevent these
foods from being able to bear the ``healthy'' claim even though they
contain important nutrients that may help consumers maintain healthy
dietary practices. The Dietary Guidelines, 2020-2025 recommends
shifting to nutrient-dense options when selecting protein foods,
specifically lean and low-fat options. We propose a <=10 percent DV
saturated fat limit for game meat, which is similar to the <2 g per
RACC saturated fat limit for the ``extra lean'' nutrient content claim
for seafood or game meat products (Sec.  101.62(e)(4)) as is used in
the current criteria for ``healthy.'' Seafood provides important
nutrients, such as beneficial fatty acids (e.g., eicosapentaenoic acid
(EPA) and docosahexaenoic acid (DHA)). The Dietary Guidelines, 2020-
2025 encourages consumption of seafood but note that almost 90 percent
of Americans do not meet that recommendation and that protein foods are
generally consumed in forms with higher amounts of saturated fat or
sodium. Thus, the Dietary Guidelines, 2020-2025 recommends replacing
processed or high-fat meats with seafood to help lower intake of
saturated fat and sodium (Ref. 1). We propose a <=10 percent DV
saturated fat limit for seafood consistent with Sec.  101.62(e)(4) and
because seafood contains beneficial nutrients that make it part of a
healthy dietary pattern.
    We are also proposing an adjustment for eggs. As mentioned
previously, the Dietary Guidelines, 2020-2025 recommends increasing
variety in protein food choices in order to meet the recommendations
for specific protein subgroups. Eggs are considered a nutrient dense
protein food option, particularly compared with some protein foods that
typically have high levels of saturated fat and sodium (e.g.,
sausages). While about three-quarters of Americans meet the
recommendation for the meat, poultry, and eggs subgroup, eggs provide
choline and vitamin D, two nutrients with notably low intakes (Ref. 1).
As noted above, using the baseline limit of 5 percent DV of saturated
fat per RACC would prevent eggs from being able to bear the ``healthy''
claim, so we are also proposing to raise the saturated fat limit for
eggs to <=10 percent DV per RACC. Beans, peas, and lentils and soy
products are inherently low in saturated fat; therefore, we are
proposing the baseline value for saturated fat of <=5 percent DV per
RACC for these foods.
    We are also proposing that the saturated fat content of nuts and
seeds does not contribute toward the overall saturated fat limit for
nut and seed products, which would be the baseline value of <=5 percent
DV per RACC. Unsalted nuts and seeds are considered nutrient dense
protein foods due to their nutrient content (e.g., they provide
important nutrients such as unsaturated fatty acids and vitamin E).
While nuts and seeds contain saturated fat, they have a fat profile
makeup of predominantly monounsaturated and polyunsaturated fats.
Numerous studies have demonstrated that replacing other sources of
saturated fat in the diet with nuts has beneficial effects on
cardiovascular disease risk, including nuts with higher saturated fat
content (Refs. 22 and 33). Based on the scientific evidence, FDA has
qualified health claims characterizing the relationship between the
consumption of nuts and a reduced risk of coronary heart disease,
including a qualified health claim for macadamia nuts which are
relatively higher in saturated fat than other nuts. More than half of
Americans do not meet the recommendation for nuts, seeds, and soy
products, and the Dietary Guidelines, 2020-2025 recommends consuming
nuts without differentiating among types and the saturated fat content
of nuts is variable. The Dietary Guidelines, 2020-2025 also recommends
reducing saturated fat by substituting certain ingredients with sources
of unsaturated fats, including using nuts and seeds in a dish instead
of cheese (Ref. 1). If nuts' and seeds' saturated fat content
contributed to the overall baseline saturated fat value of <=5 percent
DV per RACC, then most nuts and seeds would be prevented from meeting
the ``healthy'' definition (Ref. 20). Even increasing the allowable
level

of saturated fat to levels twice as much (10 percent DV) would prevent
some nuts and seeds, such as macadamia nuts, from being eligible for
the ``healthy'' claim, despite the science supporting their beneficial
impact on cardiovascular health. As mentioned above, the saturated fat
content of nut and seed varieties vary. However, excluding specific
types of nuts and seeds from being eligible for the claim would be
inconsistent with the scientific evidence demonstrating a beneficial
effect of nut consumption on health outcomes, which is the basis for
current dietary recommendations that nuts and seeds are part of a
healthy dietary pattern. We therefore propose that, for nut and seed
products, the saturated fat from the nuts and seeds do not contribute
toward the overall saturated fat limit. For example, a peanut butter
product may contain peanuts and vegetable oil. In this example, both
the peanuts and vegetable oil contain saturated fats. However, the
saturated fat from the peanuts would not contribute to the saturated
fat limit of <=5 percent DV per RACC; only the saturated fat from the
vegetable oil would contribute to the limit. Therefore, if the
saturated fat from the vegetable oil is <=5 percent DV of the RACC,
then the peanut butter would meet the saturated fat limit.
Additionally, if a product only contained nuts, such as a jar of raw,
unsalted peanuts, the product would not be subject to a saturated fat
limit in order to bear the ``healthy'' claim.
    We seek comment on whether nuts with relatively higher amounts of
saturated fat should be eligible for the ``healthy'' claim.

                                 Table 7--Protein Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
                                    Food group equivalent       Added sugar                      Saturated fat
                                           minimum                 limit       Sodium limit          limit
----------------------------------------------------------------------------------------------------------------
Game meat......................  1\1/2\ oz equivalent.......           0% DV          10% DV  10% DV.
Seafood........................  1 oz equivalent............           0% DV          10% DV  10% DV.
Egg............................  1 oz equivalent............           0% DV          10% DV  10% DV.
Beans, peas, and soy products..  1 oz equivalent............           0% DV          10% DV  5% DV.
Nuts and seeds.................  1 oz equivalent............           0% DV          10% DV  5% DV (excluding
                                                                                saturated fat
                                                                                derived from nuts
                                                                                and seeds).
----------------------------------------------------------------------------------------------------------------

    (6) Oils
    While oils are not technically a food group in the Dietary
Guidelines, 2020-2025, the Dietary Guidelines, 2020-2025 emphasizes
oils as part of a healthy dietary pattern because they are a common
characteristic of dietary patterns associated with positive health
outcomes and provide essential fatty acids (Ref. 1). As part of its
focus on shifts--that is, choosing nutrient-dense foods and beverages
in place of less healthy choices, rather than increasing intake
overall--the Dietary Guidelines, 2020-2025 recommends cooking with
vegetable oil in place of fats high in saturated fat (such as butter,
shortening, lard, and coconut oil) as a strategy to shift intake.
    We propose including 100 percent oils, oil-based spreads, and oil-
based dressings in the definition of ``healthy'' where they meet
certain specified requirements. While the Healthy U.S.-Style Dietary
Pattern at the 2,000-calorie level recommends 27 g (about 5 teaspoons)
per day of oils, we are not proposing that oil products contain a
certain quantity of oil in order to be labeled healthy. This is because
the Dietary Guidelines, 2020-2025 does not recommend high consumption
of oil, but instead that oils be used instead of fats high in saturated
fats while staying within daily calorie limits. The proposed
requirements for oils, oil-based spreads, and oil-based dressings are
discussed in further detail in this section.
    Under proposed Sec.  101.65(d)(2)(iii)(F)(1), for 100 percent oils
to bear the ``healthy'' claim, they would have to contain only oil,
which means they would contain no sodium or added sugars. For the 100
percent oil subcategory, we are proposing a limit of saturated fat of
<=20 percent of total fat. The Dietary Guidelines, 2020-2025 emphasizes
oils, such as canola, corn, olive, and sunflower oils, as part of a
healthy dietary pattern because of their fatty acid profile. However,
the Dietary Guidelines, 2020-2025 specifically does not include the fat
from some tropical plants, such as coconut oil, palm kernel oil, and
palm oil, in the category of oils because they contain a higher
percentage of saturated fats than other oils. We propose the 20 percent
limit on saturated fat to ensure that only oils with a fat profile of
predominantly monounsaturated and polyunsaturated fats, as recommended
by the Dietary Guidelines, 2020-2025, meet the criteria for
``healthy.'' The proposed 20 percent limit is consistent with the
percentage used by the National Academies to describe dietary fats low
in saturated fatty acids (Ref. 7). This 20 percent saturated fat limit
is also consistent with the saturated fat requirement for determining
the type of foods that are eligible to bear the claim on the
``Substitution of Saturated Fat in the Diet with Unsaturated Fatty
Acids and Reduced Risk of Heart Disease'' (Docket No. FDA-2007-Q-0291).
Thus, we propose a 20 percent limit on saturated fat in oils to bear
the nutrient content claim ``healthy.''
    We also propose allowing oil-based spreads, such as tub margarine,
to bear the claim ``healthy'' when they meet certain requirements. Use
of spreads made with vegetable oils can help shift intake away from
other fats high in saturated fat. The Dietary Guidelines, 2020-2025
recommends cooking and purchasing products made with oils higher in
polyunsaturated and monounsaturated fats rather than using butter,
shortening, or coconut or palm oils (Ref. 1). Thus, we propose allowing
oil-based spreads to qualify only when their fat content comes solely
from oils and where the product's overall saturated fat content is no
more than 20 percent of total fat. For such spreads, we are proposing a
limit for added sugars of 0 percent DV per RACC, as these products are
not expected to contain added sugars. We are also proposing to lower
the sodium limit to 5 percent DV per RACC for spreads, due to their
small RACCs. This approach is reasonable given that many of these
products already contain less than 5 percent DV of sodium per RACC
(Ref. 20). We seek comment on the proposed criteria for oil-based
spreads, particularly on whether the proposed saturated fat criteria
would adequately ensure that spreads that are part of a healthy dietary
pattern (because they are lower in saturated fat and higher in
unsaturated fatty acids, consistent with current nutrition science and
Federal dietary

guidance) are eligible to bear the ``healthy'' nutrient content claim.
    We also propose allowing oil-based dressings to bear the claim
``healthy'' when they meet certain requirements. Similar to oil-based
spreads, use of dressings made with vegetable oils can help shift
intake away from use of dressings made with fats that are high in
saturated fat. For oil-based dressings to bear the claim ``healthy,''
we are proposing they must contain at least 30 percent oil, which is
consistent with the oil content in the standard of identity for salad
dressing (21 CFR 169.150). Dressings must be made from oils that meet
the requirements in Sec.  101.65(d)(2)(ii)(F)(1) (i.e., saturated fat
level of the oil must be <=20 percent of total fat).
    We are proposing that oil-based dressings be permitted to contain
up to 2 percent DV of added sugars per RACC. Many dressings contain a
small amount of added sugars. We are proposing to allow a small amount
of added sugars because dressings are typically consumed with
vegetables, another highly recommended and underconsumed food group. We
are also proposing a sodium limit of <=5 percent DV per RACC for
dressings, due to their small RACCs. As with spreads, this approach is
reasonable given that many of these products already contain less than
5 percent DV of sodium per RACC (Ref. 20). Finally, we propose that the
dressings must meet a saturated fat limit of <=20 percent of total fat.
We seek comment on the proposed criteria for oil-based dressings; in
particular, we seek comment on whether the proposed 30 percent oil
level is an appropriate requirement for oil-based dressings, and on
whether the proposed saturated fat criteria adequately ensure that
dressings that are part of a healthy dietary pattern because they are
lower in saturated fat and higher in unsaturated fatty acids,
consistent with current nutrition science and Federal dietary guidance,
are eligible to bear the ``healthy'' claim.

                                   Table 8--Oil Product Requirements per RACC
----------------------------------------------------------------------------------------------------------------
                                       Food group
                                       equivalent      Added sugar    Sodium limit       Saturated fat limit
                                         minimum          limit
----------------------------------------------------------------------------------------------------------------
100% Oil...........................             N/A           0% DV           0% DV  20% of total fat.
Oil-based Spreads..................             N/A           0% DV           5% DV  20% of total fat.
Oil-based Dressing (must contain at             N/A           2% DV           5% DV  20% of total fat.
 least 30% oil and saturated fat
 level of the oil must be <=20
 percent of total fat).
----------------------------------------------------------------------------------------------------------------

c. Combination Foods
(1) Overview
    As explained previously, individual foods are foods that are
primarily comprised of one food group. In some cases, individual foods
can contain ingredients from multiple food groups, but not in high
enough quantities to equal a food group equivalent in more than one
food group. These types of foods are subject to the proposed
requirements in section VI.B.3.b (``Individual foods''). However, many
foods on the market contain multiple ingredients in combinations more
complex than those that would fit in the individual food groups. For
purposes of this rule, we refer to these foods as ``combination
foods.'' Combination foods are comprised of meaningful amounts of more
than one food group as described in more detail in the next few
paragraphs, and therefore are subject to different criteria in order to
bear the nutrient content claim ``healthy.''
    The Dietary Guidelines, 2020-2025 food group recommendations are
discussed in section V.A (``Overview of Approach''). In that section,
we discussed the daily intake recommendations of each of the food
groups and subgroups (vegetables, fruits, grains, dairy, and protein
foods) in the ``Healthy U.S.-Style Dietary Pattern,'' and explained
that we are proposing that individual foods must contain at least one
food group equivalent to be eligible for ``healthy.'' We propose
similar requirements for combination foods, taking into account the
varying composition of food groups and subgroups they contain. The
nutrients-to-limit criteria for combination foods are also based on the
criteria for individual foods, depending on the number of food group
servings contained in the combination food. The food group equivalent
and nutrients-to-limit requirements for combination foods are discussed
in more detail below.
    We are proposing different criteria for combination foods depending
on their role in the diet, which we have categorized into mixed
products, main dish products, and meal products:
     Mixed products are similar in size to an individual food
but contain more than one food group. For example, a mixed product
could include a granola product that is half whole grains and half
nuts. We are proposing to require that a mixed product contain at least
half a food group equivalent each of two different food groups per
RACC. We are also proposing nutrients-to-limit requirements that
reflect the food group composition of mixed products.
     Main dish products, defined at Sec.  101.13(m), are larger
in size (weighing at least 6 oz per labeled serving) than individual
foods and mixed products, and are intended to make a major contribution
to a meal. A main dish product might include, for example, a frozen
entr[eacute]e that is intended to be eaten with additional items to
form a full meal. Because of their size and purpose in the diet, we are
proposing to require that main dish products contain at least a food
group equivalent each of two different food groups per labeled serving.
We are also proposing specific nutrients-to-limit criteria to take into
account their purpose in the diet and their larger RACCs.
     Meal products, defined at Sec.  101.13(l), are larger in
size (weighing at least 10 oz per labeled serving) than main dish
products, and are intended to comprise all of the food for a single
eating occasion (i.e., a full meal). An example of a meal would be a
frozen dinner. Because of their size and purpose in the diet, we are
proposing to require that meal products contain at least a food group
equivalent each from three different food groups per labeled serving.
We are also proposing nutrient-to-limit criteria to take into account
their purpose in the diet and their larger RACCs.
    (2) Additional considerations for combination foods
    There are a few special considerations that apply to all
combination foods. First, under the proposed criteria for combination
foods, oils do not count as a food group equivalent. This is because
oils are not considered a food group under the Dietary Guidelines,
2020-2025, but instead an element that should be included in a healthy
dietary

pattern as a substitute for fats high in saturated fat. Individual oil
products that are eligible to bear the ``healthy'' claim include 100
percent oil products, oil-based spreads, and oil-based dressings. This
category does not include oils as an ingredient in formulated foods
(e.g., foods fried in a vegetable oil). Thus, under the proposed
criteria for combination foods, oils are not considered a food group
equivalent. This does not mean that combination foods cannot contain
oils and still qualify for the ``healthy'' claim; it means that such
oils do not contribute to the food group equivalent requirements in
order to meet the criteria to be labeled ``healthy.'' We are proposing
saturated fat limits for combination foods to help encourage the use of
healthy oils instead of fats high in saturated fat in combination
foods.
    Second, similar to the criteria for individual foods, we are
proposing that the saturated fat from nuts and seeds does not
contribute toward the saturated fat limit for nut and seed products.
This is because nuts and seeds are nutrient dense foods and consumption
of nuts and seeds has been found to be beneficial to health despite the
fact that some varieties contain levels of saturated fat that exceed
the limits set for other protein foods. Based on the scientific
evidence demonstrating beneficial effects of nut consumption, FDA has
multiple qualified health claims for nuts, and consumption of nuts and
seeds is encouraged by the Dietary Guidelines, 2020-2025, as discussed
in more detail in the individual foods section. Therefore, to make the
criteria for combination foods consistent with the criteria for
individual foods, we are proposing that when nuts and seeds are
included as ingredients in combination foods, the saturated fat
contained in the nuts and seeds does not contribute toward the
saturated fat limit. For example, for a mixed product that contains one
half serving of nuts and one half serving of whole grains, the food
would have a saturated fat limit of 5 percent DV, but the saturated fat
from nuts and seeds would not contribute to this limit.
    Finally, we are proposing that beans, peas, and lentils may be
counted as either a protein food or as a vegetable in a combination
food. As noted previously, beans, peas, and lentils (which include
foods such as kidney beans, pinto beans, white beans, black beans,
garbanzo beans, lentils, and split peas) are considered both vegetables
and protein foods in the Dietary Guidelines, 2020-2025, because their
nutrient content is similar to both protein foods and to vegetables.
Consistent with the Dietary Guidelines, 2020-2025, we propose that
beans, peas, and lentils may count as either a vegetable or a protein
food in a combination food for purposes of food group equivalent
criteria. If a combination food has more than one type of food from the
beans, peas, and lentils subgroup, in amounts such that each food meets
the food group requirements individually, the amount of one food from
the beans, peas, and lentils subgroup can meet the vegetable group
requirement while another food from the same subgroup can be used to
meet the protein food requirement. However, if the food product has
only one type of food from the beans, peas, and lentils subgroup, the
one type cannot count toward both the vegetable and protein food group
requirements in the same combination food. For example, if a food
product had a \1/2\ cup of split peas and a \1/2\ cup of black beans,
the black beans could be counted as one food group equivalent of
protein foods and the split peas as one food group equivalent of
vegetables in a combination food. However, if a food product had one
cup only of black beans, it could be counted as one food group
equivalent of vegetables or one food group equivalent of protein foods,
but not as both.
    (3) Combination foods criteria.
    In addition to the special considerations just described, we are
proposing specific criteria for food group equivalents and nutrients to
limit for mixed products, main dishes, and meals. These criteria are
detailed in the following sections.
    (i) Mixed products--Mixed products are foods that contain multiple
ingredients but do not contain a full food group equivalent per RACC of
any single Dietary Guidelines, 2020-2025 food group. A mixed product
could include, for example, a trail mix that contains fruit and nuts,
where neither of these components are in sufficient quantities to equal
a full food group equivalent. Where a product contains more than one
food group and does not contain a full food group equivalent of any one
food group, we are proposing that it can bear the ``healthy'' claim if
it contains a sufficient amount from two different food groups.
Specifically, we propose that a mixed product must contain at least
half of a food group equivalent each of two different food groups per
RACC. The amount in a food group equivalent is specified in proposed
Sec.  101.65(d)(2)(ii). For example, the aforementioned trail mix could
meet the food group equivalent requirement if it contains \1/4\ c-eq
fruit (half a fruit food group equivalent) and \1/2\ oz-eq nuts (half a
food group equivalent of nuts and seeds). One food group equivalent
equals \1/4\ of the total daily recommended amount of each of the
recommended food groups. For individual foods we have set a minimum
amount of one full FGE. For mixed products, we reduce this amount to
half of a food group equivalent in order to allow multi-component
foods, that contribute to meeting the daily recommended amounts of food
groups, to bear a ``healthy'' claim. For consumers who use the
``healthy'' claim in constructing their diets, mixed products bearing a
``healthy'' claim that contain less than half of a food group
equivalent may make it difficult for consumers to meet their total
daily amounts of recommended food groups. However, we request comments
on whether lower amounts of food group equivalents (e.g., \1/4\ FGE)
would be similarly effective as \1/2\ FGE in helping consumers meet
their total daily amounts of recommended food groups for multicomponent
foods.
    We also propose that mixed products would have to meet certain
nutrients-to-limit criteria to bear the ``healthy'' claim. Because they
contain at least two half food group equivalents, mixed products
contain an overall food group equivalent similar to that of individual
foods. We calculated the nutrients-to-limit criteria for mixed products
by finding the average of the nutrients to limit for their component
food groups. For example, for a mixed product that contains a half food
group equivalent of dairy and a half food group equivalent of fruit,
the added sugars limit would be 2\1/2\ percent DV per RACC (the average
of 5 percent DV for dairy and 0 percent DV for fruit), sodium limit
would be 10 percent DV per RACC (as both food groups have the same
sodium limit), and the saturated fat limit would be 7\1/2\ percent DV
per RACC (the average of 10 percent DV for the dairy and 5 percent DV
for the fruit). Because there is variation in the saturated fat limits
for different subgroups of protein foods, the saturated fat limit for
mixed products containing protein also varies depending on the type of
protein in the product. The proposed nutrients to limit criteria per
RACC for each type of mixed product are reflected in table 9.

                                       Table 9--Mixed Product Requirements
----------------------------------------------------------------------------------------------------------------
                                               Added sugar
        Food group equivalents (FGE)              limit       Sodium limit           Saturated fat limit
----------------------------------------------------------------------------------------------------------------
\1/2\ FGE fruit, vegetable, or protein + \1/          0% DV          10% DV  5% DV or 7\1/2\% DV if the protein
 2\ FGE fruit, vegetable, or protein.                                         is game meat, seafood, or egg.
\1/2\ FGE whole grain + \1/2\ FGE fruit,         2\1/2\% DV          10% DV  5% DV or 7\1/2\% DV if the protein
 vegetable, or protein.                                                       is game meat, seafood, or egg.
\1/2\ FGE dairy + \1/2\ FGE fruit,               2\1/2\% DV          10% DV  7\1/2\% DV or 10% DV if protein is
 vegetable, or protein.                                                       game meat, seafood, or egg.
\1/2\ FGE dairy + \1/2\ FGE whole grain....      7\1/2\% DV          10% DV  7\1/2\% DV.
----------------------------------------------------------------------------------------------------------------

    (ii) Main dish products--A main dish product is defined by our
regulations at Sec.  101.13(m) as a food that makes a major
contribution to a meal by weighing at least 6 oz per labeled serving;
and containing not less than 40 g of food, or combinations of foods,
from each of at least two food groups (as specified in Sec.
101.13(m)(1)(ii)). In addition to the food group requirements, the
product must be represented as, or in a form commonly understood to be,
a main dish (e.g., not a beverage or dessert). Such representations may
be made either by statements, photographs, or vignettes.
    Main dish products are food products of significant size intended
to contain most of the components of a meal. Because of their size and
purpose in the diet, we propose that these types of food products must
contain at least one food group equivalent each of two different food
groups or subgroups as specified by proposed Sec.  101.65(d)(2)(ii).
These food group requirements are different and distinct from the food
groups specified in Sec.  101.13(m)(1)(ii). In particular, fruits and
vegetables are two separate food groups for the purposes of the
``healthy'' claim (where they are one combined food group under Sec.
101.13(m)(1)(ii)), consistent with the Dietary Guidelines, 2020-2025.
An example of a main dish product that might bear the ``healthy'' claim
would be a vegetable lasagna product that contains a \1/2\ c-eq of
mixed vegetables (vegetable food group equivalent) and \3/4\ oz-eq of
whole grains (whole grain equivalent) per labeled serving.
    Main dish products would also be subject to specific nutrients-to-
limit criteria, which would apply per labeled serving. We calculated
the nutrients-to-limit criteria for main dish products by adding
together the nutrient limits for the two individual food groups that
make up the main dish. For example, for the vegetable lasagna main
dish, the added sugars limit would be 5 percent DV (5 percent DV for
whole grains plus 0 percent DV for vegetables), the sodium limit would
be 20 percent DV (10 percent DV for whole grains plus 10 percent DV for
vegetables), and the saturated fat limit would be 10 percent DV (5
percent DV for whole grains plus 5 percent DV for vegetable).
    As with mixed products, because there is variation in the saturated
fat limits for different subgroups of protein foods, the saturated fat
limit for mixed products containing protein foods also varies depending
on the protein subcategory in the product. For example, a main dish
containing salmon and brown rice would have a higher saturated fat
limit (15 percent DV) than a main dish containing tofu and brown rice
(10 percent DV). The proposed nutrients to limit criteria per labeled
serving for each type of main dish product are reflected in table 10.

                                        Table 10--Main Dish Requirements
----------------------------------------------------------------------------------------------------------------
                                               Added sugar
        Food group equivalents (FGE)              limit       Sodium limit           Saturated fat limit
----------------------------------------------------------------------------------------------------------------
1 FGE fruit, vegetable, or protein + 1 FGE            0% DV          20% DV  10% DV or 15% DV if the protein is
 fruit, vegetable, or protein.                                                game meat, seafood, or egg.
1 FGE whole grain + 1 FGE fruit, vegetable,           5% DV          20% DV  10% DV or 15% DV if the protein is
 or protein.                                                                  game meat, seafood, or egg.
1 FGE dairy + 1 FGE fruit, vegetable, or              5% DV          20% DV  15% DV or 20% DV if protein is game
 protein.                                                                     meat, seafood, or egg.
1 FGE dairy + 1 FGE whole grain............          10% DV          20% DV  15% DV.
----------------------------------------------------------------------------------------------------------------

    (iii) Meal products--A meal product is defined by our regulations
at Sec.  101.13(l) as a food that makes a major contribution to the
total diet by weighing at least 10 oz per labeled serving and
containing no less than three 40 g portions of food, or combinations of
foods, from two or more of the food groups specified at Sec.
101.13(l)(1)(ii). In addition to the food group contribution
requirements, the product must be represented as, or must be in a form
commonly understood to be, a breakfast, lunch, dinner, or meal. As with
main dishes, such representations may be made either by statements,
photographs, or vignettes.
    For a meal product to be eligible to bear the ``healthy'' claim, we
propose in Sec.  101.65(d)(3)(iv) that it must contain at least one
full food group equivalent each of three different food groups or
subgroups specified by the proposed regulation in Sec.  101.65(d)(2)(i)
through (iv) (vegetable, fruit, whole grain, dairy, or protein foods)
per labeled serving. As with main dish products, these food group
requirements are different and distinct from the food groups in Sec.
101.13(l)(1)(ii). An example of a meal product containing the necessary
food group equivalents to bear the ``healthy'' claim would be a frozen
salmon dinner containing 1 oz-eq salmon, \1/2\ c-eq green beans, and
\3/4\ oz-eq brown rice, representing a food group equivalent each of
seafood (protein food), vegetables, and whole grains.
    As with mixed products and main dish products, meal products would
also be subject to specific nutrients-to-limit criteria, which would
apply per labeled serving. The nutrients-to-limit criteria for meals
are the sum of the requirements for the three individual food groups
that comprise the meal. For example, in the salmon meal, the added

sugars limit would be 5 percent DV (0 percent DV for vegetable, 0
percent DV for seafood, and 5 percent DV for whole grain), the sodium
limit would be 30 percent DV (10 percent DV each for vegetable,
seafood, and whole grain), and the saturated fat limit would be 20
percent DV (5 percent DV for vegetable, 10 percent DV for seafood, and
5 percent DV for whole grain).
    As with mixed products and main dish products, because there is
variation in the saturated fat limits for different subgroups of
protein foods, the saturated fat limit for mixed products containing
protein foods also varies depending on the protein subcategory in the
product. The proposed nutrients-to-limit criteria per labeled serving
for each type of meal product are reflected in table 11.

                                       Table 11--Meal Product Requirements
----------------------------------------------------------------------------------------------------------------
                                               Added sugar
        Food group equivalents (FGE)              limit       Sodium limit           Saturated fat limit
----------------------------------------------------------------------------------------------------------------
1 FGE fruit, vegetable, or protein + 1 FGE            0% DV          30% DV  15% DV or 20% DV if the protein is
 fruit, vegetable, or protein + 1 FGE                                         game meat, seafood, or egg.
 fruit, vegetable, or protein.
1 FGE whole grain + 1 FGE fruit, vegetable,           5% DV          30% DV  15% DV or 20% DV if the protein is
 or protein + 1 FGE fruit, vegetable, or                                      game meat, seafood, or egg.
 protein.
1 FGE dairy + 1 FGE fruit, vegetable, or              5% DV          30% DV  20% DV or 25% DV if protein is game
 protein + 1 FGE fruit, vegetable, or                                         meat, seafood, or egg.
 protein.
1 FGE dairy + 1 FGE whole grain + 1 FGE              10% DV          30% DV  20% DV or 25% DV if the protein is
 fruit, vegetable, or protein.                                                game meat, seafood, or egg.
----------------------------------------------------------------------------------------------------------------

    (iv) Water--We are proposing to include plain and plain, carbonated
water in the updated definition of ``healthy.'' According to the
National Academies (Ref. 23), water is the largest single constituent
of the human body and is essential for cellular homeostasis and life.
It provides the solvent for biochemical reactions, is the medium for
material transport, and has unique physical properties (high specific
heat) to absorb metabolic heat. Water is essential to maintain vascular
volume, to support the supply of nutrients to tissues, and to remove
waste. Body water deficits challenge the ability of the body to
maintain homeostasis during perturbations (e.g., sickness, physical
exercise, or climatic stress) and can impact function and health (Ref.
23). The total water intake needed to prevent the deleterious effects
of dehydration comes from drinking water, water in other beverages, and
water (moisture) in food. Approximately 80 percent of total water
intake comes from drinking water and other beverages.
    Water itself is not categorized under a recommended food group in
the Dietary Guidelines, 2020-2025. However, water is emphasized in the
Dietary Guidelines, 2020-2025 beverage recommendations. The Dietary
Guidelines, 2020-2025 recommends that the ``primary beverages
consumed'' should be ``beverages that are calorie-free--especially
water--or that contribute beneficial nutrients, such as fat-free and
low-fat milk and 100 percent fruit juice'' (Ref. 1). Organizations,
such as the National Academy of Medicine, and public health agencies,
such as the Centers for Disease Control and Prevention, widely
recognize the benefits of water, that it is a preferred source of
hydration, and is necessary for proper functioning of the human body,
and, accordingly, recommend increased availability of drinking water
(Refs. 24-26).
    Under the existing regulation at Sec.  101.65(d), water cannot be
labeled ``healthy'' because it does not meet the existing nutrient-
related criteria. Beverages included in a healthy dietary pattern, such
as water, are those that allow nutrient needs to be met through the
dietary pattern by allowing consumers to meet the food group
recommendations without exceeding calorie needs. Thus, consideration of
water under the ``healthy'' claim is appropriate as water is an
important beverage for maintaining healthy dietary practices due to its
nutrient content and how the profile affects the overall dietary
pattern. Further, the Dietary Guidelines, 2020-2025 recommends making
shifts toward healthier food and beverage choices, such as choosing
water in the place of sugar-sweetened beverages and emphasize choosing
nutrient-dense foods to help achieve healthy dietary patterns within
calorie limits. To help achieve this, the Dietary Guidelines, 2020-2025
further recommends limiting added sugars in the diet, since a healthy
dietary pattern within calorie limits is difficult to achieve when
added sugars exceed 10 percent of calories. The major source of added
sugars in the typical U.S. diet is beverages, including sugar-sweetened
beverages and sweetened coffees and teas, which account for 35 percent
of all added sugars consumed by the U.S. population (Ref. 1). Thus, the
absence of added sugars is particularly relevant to inclusion of water
when defining the implied nutrient content claim ``healthy.'' Further,
the Dietary Guidelines, 2020-2025 recommends selecting calorie-free
beverages, such as water, to help achieve a healthy dietary pattern
within calorie limits.
    In addition, the Dietary Guidelines, 2020-2025 specifically calls
out water, 100 percent fruit juice, and fat-free/low-fat milk as
beverages to consume in a healthy dietary pattern. As discussed
previously, 100 percent vegetable juice, 100 percent fruit juice, and
fat-free and low-fat milk are eligible to bear the nutrient content
claim ``healthy'' under this proposed rule; therefore, it would be
consistent with a healthy dietary pattern to also allow water to bear
the ``healthy'' claim. Moreover, the Dietary Guidelines, 2020-2025
recommends water without restriction, in contrast to milk and 100
percent juice beverages, which should be consumed in the context of the
recommended intake amounts of each individual food group and within
calorie limits.
    Based on these considerations, we propose including plain water--
both still and carbonated--in the definition of ``healthy.'' We seek
comment on whether water should be included in the definition, and
whether ``water'' should be expanded, for example, to include waters
containing non-caloric flavors or other non-caloric ingredients. In
addition, because only labeled water (e.g., bottled water) would
commonly bear the ``healthy'' claim, we also seek comment on whether
allowing bottled water to be labeled ``healthy'' could potentially lead
some consumers to believe that bottled water is healthier than tap
water. Beyond water, the Dietary Guidelines, 2020-2025 states that
beverages that are calorie-free should be primary beverages consumed
and that coffee and tea with little, if any, sweeteners or cream are
also beverage options that can be part of a healthy

dietary pattern. Therefore, we also seek comment on the eligibility of
calorie-free beverages, coffee, and tea to bear the ``healthy'' claim.
4. Records Requirements
    We are proposing limited recordkeeping requirements on
manufacturers to facilitate FDA's ability to verify compliance with
certain aspects of the proposed rule. See section V. (``Legal
Authority'') for the discussion of our legal authority for proposing
recordkeeping and records access requirements. Compliance with the
requirements for nutrients to limit will be verifiable for all food
products using the Nutrition Facts Label; that is, it will be apparent
from the Nutrition Facts Label whether a food meets the applicable
criteria for saturated fat, sodium, and added sugars content, and thus
no additional records are required. For some foods, we will also be
able to use the product label (including the Nutrition Facts Label, the
ingredient list, the statement of identity, and any other information)
to verify compliance with the food group requirements. For example, it
would be apparent from the ingredient list of an oil product whether
the product contains 100 percent oil. Similarly, it would likely be
ascertainable from the ingredient list of a frozen spinach product that
contains only spinach and salt whether the product contains enough
spinach (vegetable food group) to bear the ``healthy'' claim.
    However, for certain foods bearing the ``healthy'' claim, the label
will not be sufficient to verify that the food meets the requirements
for ``healthy'' as described in Sec.  101.65(d)(3). Specifically, the
label will not provide sufficient information for FDA to verify that
certain foods containing multiple components (such as most grain
products and all combination foods) meet the food group equivalent
requirements to bear the claim. For these foods, we are proposing to
require recordkeeping to demonstrate compliance with the food group
equivalent requirements, given the nature of the information necessary
to determine compliance and the number of foods potentially affected.
We are proposing to require the manufacturer of a food bearing the
implied nutrient content claim ``healthy'' to make and keep records,
identified in proposed Sec.  101.65(d)(4), where the food group
equivalent(s) is/are not apparent based on the label of the food. These
records would verify that the food bearing the ``healthy'' claim meets
the food group equivalent requirements. This recordkeeping requirement
would not apply to water or to raw, whole fruits and vegetables, which
do not have food group equivalent requirements.
    This recordkeeping requirement would always apply to manufacturers
of mixed products, main dish products, and meal products, as these
products contain multiple components and it will not be clear how much
of each food group is contained in the products without additional
information. For individual foods, it will depend on the food whether
such records are required. For example, a manufacturer of a multigrain
bread containing both whole wheat and refined wheat flours would be
required to keep records under this section. This is because it would
not be apparent based on the label whether a serving of the bread
contains at least \3/4\ oz-equivalent of whole grains. By contrast, a
manufacturer would not be required to keep such records for a 100
percent whole wheat bread, because the ingredient statement on the
information panel would indicate that the bread contains only whole-
grain flour, and therefore, it would be apparent from the label that
the bread contains the required \3/4\ oz-eq of whole grains (as one
slice of whole wheat bread would be a 1 oz-eq of whole grains). Other
examples of individual foods that would not be subject to the
recordkeeping provision include dried fruit, plain yogurt, and brown
rice.
    Where the proposed requirements cannot be verified using the label,
only the manufacturer will have the information required to determine
whether the product meets the food group equivalent requirements for
bearing the ``healthy'' claim. The information contained in
manufacturers' records is an accurate and practical method for ensuring
that the nutrient content claim is used in accordance with Sec.
101.65(d) and that the food labeling complies with section 403(r) of
the FD&C Act. We tentatively conclude that the records will provide FDA
with the necessary means to determine compliance with the food group
equivalent requirements for bearing the ``healthy'' nutrient content
claim.
    Manufacturers will be responsible for the type of records they
maintain and are not required to produce any specific form or document.
The manufacturer is in the best position to know which of its records
provide the documentation required to determine compliance. Records
used to verify that a food meets the food group equivalent requirements
for ``healthy'' could include recipes or formulations, batch records
providing data on the weight of certain ingredient contributions to the
total batch, certificates of analysis from ingredient suppliers, or
other appropriate verification documentation that provides the needed
assurance that a food bearing the ``healthy'' claim complies with the
food group equivalent requirements. We expect that manufacturers
choosing to use the ``healthy'' claim will have the type of records
needed to verify that the food meets the requirements, given that they
will have to analyze their product to determine whether it meets the
requirement in order to bear the claim. The proposed records
requirement is intended to provide flexibility in what records the
manufacturer makes available to FDA to verify the claim. The records
provided during an inspection by FDA would only need to provide
information on the food group equivalents because the information on
nutrients to limit will be available on the food package. Other
information about the food can be redacted if necessary to ensure
confidentiality of a food product formulation.
    We recognize that the composition of processed foods can vary
depending on the recipe or formulation, the suppliers of ingredients,
etc. For example, the amounts of given components in a mixed product,
such as granola, may change if a manufacturer changes ingredient
suppliers or changes a recipe. In order to verify the composition of a
packaged food, the manufacturer would need to ensure that the records
it provides to us to verify that the food bearing the ``healthy'' claim
meets the food group equivalent requirements of Sec.  101.65(d)(3),
and, as appropriate, can distinguish among the same or similar product
that the manufacturer has in the marketplace that may contain differing
amounts of its components. For example, the manufacturer may have to
distinguish among different granola bars with different amounts of
qualifying food groups or the same granola with different formulations.
    Although some manufacturers may have large numbers of foods bearing
the ``healthy'' claim that would necessitate recordkeeping to verify
that they meet the requirements, we do not think that determining the
composition of the foods and maintaining that information would present
undue difficulty for manufacturers. With or without a ``healthy''
claim, manufacturers are required to know what ingredients and
nutrients are in the foods they produce and to provide that information
truthfully to consumers. Manufacturers have experience with determining
the ingredient composition of the food they produce and with the
maintenance of related records, either written or

electronic. We seek comment on the accuracy of these assumptions.
    We recognize that manufacturers frequently obtain ingredients from
suppliers in a (sometimes extensive) supply chain, and that these
ingredients often contain multiple ingredients themselves.
Manufacturers should be able to work with their suppliers to obtain the
necessary information to ensure that any food bearing the claim
``healthy'' meets the regulatory requirements to bear the claim.
Ingredient suppliers should know the contents of the ingredients they
provide to food manufacturers, and this information will need to be
properly communicated.
    We are proposing that such records must be kept for a period of 2
years after introduction or delivery for introduction of the food into
interstate commerce. We selected this period to ensure that records can
be made available for review and copying as long as the product is
available for purchase in the marketplace. Due to the significant
number of packaged food products in the marketplace that could meet the
requirements under Sec.  101.65(d), we recognize that there could be a
wide variation of manufacturing practices, shipping practices, and
shelf lives among packaged foods bearing the ``healthy'' claim. We
believe that it is most practical to establish a single recordkeeping
period for this provision rather than establishing different
recordkeeping periods for different products or for different
manufacturing or shipping practices. It would be more difficult for FDA
to establish a compliance program for one segment of the regulated
industry that starts the recordkeeping process when the food is made,
and a different compliance program for another segment of the industry
that starts the recordkeeping process when the food is shipped. For
manufacturers who make several food products, we expect it would be
easier for them to use the same recordkeeping period for all products
rather than use different recordkeeping periods for different products.
Therefore, we have designed a compliance program that involves a single
recordkeeping period. The proposed record requirements for purposes of
verifying the ``healthy'' claim are separate and distinct from other
record requirements.
    We are proposing that records must be made available to us for
examination or copying during an inspection upon request; this is
consistent with our other recordkeeping regulations (see, e.g., 21 CFR
111.605 and 111.610, and 81 FR 33742). The records would need to be
reasonably accessible (access to records within 24 hours can be
considered reasonable) to FDA during an inspection at each
manufacturing facility (even if not stored onsite) to determine whether
the food meets the requirements for bearing the ``healthy'' claim.
Records that can be immediately retrieved from another location by
electronic means are considered reasonably accessible.
    We anticipate that manufacturers may have concerns about the
confidentiality of the information inspected by us under this proposal.
We would protect confidential information from disclosure, consistent
with applicable statutes and regulations, including 5 U.S.C. 552(b)(4),
18 U.S.C. 1905, and 21 CFR part 20. Thus, we are proposing to require
that manufacturers must make and keep records to verify that the food
meets the food group equivalent requirements of Sec.  101.65(d)(2)
where the food group equivalent contained in the product is not
apparent based on the label of the food.
    We are also proposing, in Sec.  101.65(d)(4), that such records
must be kept for a period of 2 years after introduction or delivery for
introduction of the food into interstate commerce. In addition, we are
proposing to require that such records must be provided upon request,
during an inspection, for official review and photocopying or other
means of reproduction, and that records may be kept either as original
records, true copies (such as photocopies, pictures, scanned copies,
microfilm, microfiche, or other accurate reproductions of the original
records), or electronic records. All electronic records that are
maintained to comply with the proposed requirements would need to
comply with 21 CFR part 11.
    We seek comment on the proposed requirements for the types of
records that must be made and kept and the length of time that the
records must be kept.

VII. Proposed Effective and Compliance Dates

    We intend that any final rule resulting from this rulemaking become
effective 60 days after the date of the final rule's publication in the
Federal Register with a compliance date 3 years after the effective
date. We recognize that it may take industry time to analyze products,
update their records of product labels, and print new labels. A
compliance date that is 3 years after the effective date is intended to
provide industry time to revise labeling to come into compliance with
the new labeling requirements while balancing the need for consumers to
have the information in a timely manner. We seek comment on the
proposed compliance date.

VIII. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
The Office of Information and Regulatory Affairs has designated this
proposed rule to be an economically significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because a large proportion of covered entities are small
businesses, we find that the proposed rule will have a significant
economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
result in an expenditure in at least one year that meets or exceeds
this amount.

B. Summary of Costs and Benefits

    Some consumers use nutrient content claims such as ``healthy'' to
inform their food purchases. We estimate that a small number (0 to 0.4
percent of people that try to follow current dietary guidelines) of
these consumers would use the ``healthy'' implied nutrient content
claim to make meaningful, long-lasting food purchasing decisions. If
the foods using the ``healthy'' claim more closely align with Federal
dietary guidance, the claim can assist consumers who are selecting
those products in choosing a more healthful diet, which may result in
lower chronic, diet-related diseases, including

cardiovascular disease and type 2 diabetes.
    Quantifiable benefits of the proposed rule are the estimated
reduction over time in all-cause morbidity stemming from consumers
selecting and consuming more healthful foods. This is calculated
through the negative association between a Healthy Eating Index score
and all-cause mortality. Discounted at three percent over 20 years, the
mean present value of benefits accrued to consumers using the
``healthy'' nutrient content claim is $455 million, with a lower bound
estimate of $15 million and an upper bound estimate of $1.3 billion.
Discounted at seven percent over 20 years, the mean present value of
benefits of the proposed rule is $290 million, with a lower bound
estimate of $9 million and an upper bound estimate of $857 million.
    Quantified costs to manufacturers associated with updating the
``healthy'' claim are labeling, reformulating, and recordkeeping.
Overall, about 34,000 UPCs, or 14 percent of total UPCs, qualify for
the existing ``healthy'' implied nutrient content claim but only 5
percent (12,000 UPCs) choose to label. The use of the ``healthy''
nutrient content claim is voluntary, but if the proposed rule results
in some products needing to remove the claim to avoid being misbranded,
manufacturers would incur costs due to the rule. Manufacturers with
food products currently using the ``healthy'' nutrient content claim
would need to confirm whether the products meet the proposed criteria
and decide whether a label change is needed. Manufacturers with
products that currently do not meet the ``healthy'' criteria but do
meet the proposed criteria have the option of labeling these products.
In some cases, manufacturers may choose to reformulate a product so
that it meets the proposed criteria. Some recordkeeping is required for
certain products using the proposed ``healthy'' claim because the
required food components equivalents are likely to increase time spent
on recordkeeping. It is possible that manufacturers of products that
include the term ``healthy'' within the brand name may choose to
rebrand products instead of reformulating. We lack the data to quantify
this effect but discuss it qualitatively. Discounted at three percent
over 20 years, the mean present value of costs accrued to manufacturers
using the ``healthy'' nutrient content claim, assuming the current 5
percent adoption rate, is $276 million, with a lower bound of $128
million and an upper bound of $505 million. Discounted at seven percent
over 20 years, the mean present value of costs of the proposed rule is
$237 million, with a lower bound of $110 million and an upper bound of
$434 million.

                                    Table 12--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
                                                                   [In millions 2020$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                  Primary       Low        High    ------------------------------------
                   Category                      estimate    estimate    estimate      Year      Discount     Period                  Notes
                                                                                dollars    rate (%)     covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.......       $27.4       $0.89       $80.9        2020           7          20  Monetized benefits account for
                                                      30.6        0.99        90.4        2020           3          20   consumer's lost pleasure from
                                                                                eating less healthy foods they
                                                                                may nevertheless prefer.
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7  ..........  ................................
                                                                                3
                                               ---------------------------------------------------------------------------------------------------------
    Qualitative...............................  To the extent consumers use the ``healthy'' nutrient content claim to   ................................
                                                maintain healthy dietary practices, following a healthy diet could
                                                reduce the risk of morbidity and prolong life.
                                               ---------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year.......        22.3        10.4        40.9        2020           7          20  ................................
                                                      18.5         8.6        33.9        2020           3          20
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7  ..........  ................................
                                                                                3
    Qualitative...............................  ..........  ..........  ..........  ..........  ..........  ..........  ................................
Transfers:
    Federal Annualized Monetized $millions/     ..........  ..........  ..........  ..........           7  ..........  ................................
     year.                                                                                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/year.....  ..........  ..........  ..........  ..........           7  ..........  ................................
                                                                                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None...

    Distributional: American Indian, Alaskan
     Native, Hispanic, and Non-Hispanic Black
     adults and children, as well as the lower-
     income or publicly insured may accrue a
     larger proportion of the estimated health
     benefits. However, this distributional
     shift may be reduced if these populations
     do not use, or do not have access to,
     products that bear the ``healthy''
     nutrient content claim to meaningfully
     change their diet. Finally, any
     distributional shift may be dampened if
     costs are passed onto consumers in the
     form of increased prices of foods labeled
     as ``healthy''. Small Business: Potential
     impacts on small manufacturers of
     packaged food and beverages due to
     removing the ``healthy'' claim or
     reformulating some products.
    Wages: None...............................
    Growth: None..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We seek comment on our estimates of costs and benefits of this
proposed rule.
    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 26) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IX. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A
description of these provisions is given in the Description section of
this document with an estimate of the annual recordkeeping and third-
party disclosure burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    FDA seeks comments on these topics: (1) whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Food Labeling Regulations, OMB Control Number 0910-0381--
Revision.
    Description of Respondents: The respondents to this information
collection are manufacturers of food products using the ``healthy''
implied nutrient content claim marketed in the United States.
    Description: The proposed rule would revise Sec.  101.65(d) to
require manufacturers using the ``healthy'' implied nutrient content
claim on their products to make and keep written records to verify that
the products comply with this requirement. Examples of these records
include analyses of databases, recipes, formulations, information from
recipes or formulations, or batch records. Manufacturers must provide
these records upon request from FDA during an inspection for official
review and photocopying or other means of reproduction.
    The proposed rule would also require some manufacturers to relabel
products to comply with the criteria for the ``healthy'' implied
nutrient content claim. A product that does not meet the criteria would
need to have the term removed from its label, and a product that became
eligible would be permitted to use the term in its label.
    We estimate the recordkeeping burden of this collection of
information as follows:

                                                   Table 13--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
         21 CFR section; activity              Number of       records per      Total annual      Average  burden per  recordkeeping       Total hours
                                             recordkeepers     recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.65; recordkeeping to verify                      1,839                1            1,839   0.5 (30 minutes)........................             920
 ``healthy'' nutrient content claim.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The proposed rule requires that each manufacturer of a food that
bears the implied nutrient content claim ``healthy'' must make and keep
written records to verify that the food meets the food group equivalent
requirements when it is not apparent from the label of the food.
Examples of records include analyses of databases, recipes,
formulations, information from recipes or formulations, or batch
records. However, the product label (including the Nutrition Facts
label (NFL), the ingredient list, the statement of identity, and any
other information) may be used to verify compliance with the food group
requirements for certain foods. For example, it would be apparent from
the ingredient list of an oil product whether the product contains 100
percent oil. Similarly, it would likely be ascertainable from the
ingredient list of a frozen spinach product that contains only spinach
and salt whether the product contains enough spinach (vegetables) to
bear the ``healthy'' claim. Thus, this recordkeeping estimate does not
include food groups where the equivalent requirements are apparent from
the label of the food. The estimates in table 13 are based on the 5,516
products estimated to need recordkeeping in table 11 of the Preliminary
Regulatory Impact Analysis (PRIA) (Ref. 26). A PRA analysis covers a 3-
year period, so this number is divided by 3 to get 1,839 as an annual
number of records maintained (1 record for each product). In table 13,
FDA estimates that each year 1,839 manufacturers will each make and
keep 1 written record for a total of 1,839 records. We estimate that
each record will require 15 to 30 minutes of recordkeeping for an
annual recordkeeping burden of 919.5 hours, rounded to 920 (1,839
records x 0.5 hour).

                                                   Table 14--Estimated One-Time Relabeling Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of
                     Activity                          Number of     disclosures per    Total annual   Average  burden    Total hours     Total capital
                                                      respondents       respondent      disclosures    per  disclosure                      costs \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Relabel for ``healthy'' claim.....................           5,987                1            5,987                1            5,987      $14,715,909
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ One-time labeling burden.
\2\ There are no operating and maintenance costs associated with this collection of information.

    We assume there are two categories of UPCs that could require re-
labeling. First, if a UPC currently labeled ``healthy'' does not meet
the proposed criteria, the manufacturer could choose to remove the
``healthy'' claim or reformulate. In either case, the label would need
to be changed, either to remove the ``healthy'' claim or to change the
NFL after reformulation. Given the current UPCs labeled ``healthy''
that would not qualify for the proposed criteria, we estimate the
number of UPCs that would remove the ``healthy'' claim or reformulate.
Second, if a UPC does not currently qualify as ``healthy'' but would
meet the proposed criteria, the manufacturer could choose to add the
``healthy'' claim. Table 7 of the PRIA estimates the need for 17,960
total label changes. Because this claim is voluntary, we do not know
how many establishments will make labeling changes. For the purpose of
this analysis, we assume that the number of respondents is the same as
the number of disclosures.
    We estimate that each manufacturer will relabel 1 product. A PRA
analysis covers a 3-year period, so the total number of label changes,
17,960, is divided by 3 to get 5,987 annual disclosures. Each
disclosure will take an estimated 1 hour to complete for an annual
third-party disclosure burden of 5,987 hours. Based on table 7 of the
PRIA, we estimate that there will be an annual capital cost of
$14,715,909 over 3 years associated with relabeling with the total
capital cost being $44,147,727. This is the cost of designing a revised
label and incorporating it into the manufacturing process. We believe
that this will be a one-time burden.
    To ensure that comments on this information collection are
received, OMB recommends that written comments be submitted through
reginfo.gov (see ADDRESSES). All comments should be identified with the
title of the information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), we have submitted the information collection provisions of
this proposed rule to OMB for review. These information collection
requirements will not be effective until FDA publishes a final rule,
OMB approves the information collection requirements, and the rule goes
into effect. FDA will announce OMB approval of these requirements in
the Federal Register.

XI. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe . . . a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.''
    Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express
preemption provision. Section 403A(a) of the FD&C Act provides, with
minor exceptions, that no State or political subdivision of a State may
directly or indirectly establish under any authority or continue in
effect as to any food in interstate commerce with respect to any
requirement for nutrition labeling of food that is not identical to

requirements established under section 403(r) of the FD&C Act.
    The express preemption provision of section 403A(a) of the FD&C Act
does not preempt any State or local requirement respecting a statement
in the labeling of food that provides for a warning concerning the
safety of the food or component of the food (section 6(c)(2) of the
Nutrition Labeling and Education Act of 1990, Public Law 101-535
(1990)); however, it is possible that such a requirement could be
preempted on another basis, such as under principles of implied
preemption. If this proposed rule is made final, the final rule would
create requirements that fall within the scope of section 403A(a) of
the FD&C Act.

XII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. We solicit comments from tribal officials
on any potential impact on Indian Tribes from this proposed action.

XIII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

    1. U.S. Department of Agriculture and U.S. Department of Health
and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th
Edition. December 2020. Available at DietaryGuidelines.gov.
    2. * Centers for Disease Control and Prevention. National Center
for Chronic Disease Prevention and Health Promotion. Retrieved from:
https://www.cdc.gov/chronicdisease/index.htm.
    3. * Centers for Disease Control and Prevention. National Center
for Health Statistics. ``Leading Causes of Death.'' Retrieved from:
https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm.
    4. Lloyd-Jones, D., R.J. Adams, T.M. Brown, et al. ``Heart
Disease and Stroke Statistics--2018 Update: A Report from the
American Heart Association.'' Circulation,137:e67-e492, 2018. DOI:
10.1161/CIR.0000000000000558.
    5. * Centers for Disease Control and Prevention. ``National
Diabetes Statistics Report, 2017.'' Retrieved from: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
    6. * National Cancer Institute. Surveillance, Epidemiology, and
End Results (SEER) Program. ``Cancer Stat Facts: Cancer of Any
Site.'' Retrieved from: https://seer.cancer.gov/statfacts/html/all.html.
    7. IOM of the National Academies. ``Dietary Reference Intakes
for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol,
Protein, and Amino Acids (Macronutrients), Chapter 8: Dietary Fats:
Total Fat and Fatty Acids'': Washington, DC: National Academies
Press; 2002.
    8. IOM of the National Academies. ``Sodium Intake in
Populations: Assessment of Evidence,'' Washington, DC: National
Academies Press; 2013, pp. 235-284.
    9. IOM of the National Academies. ``Dietary Reference Intakes
for Water, Potassium, Sodium, Chloride, and Sulfate, Chapter 6:
Sodium and Chloride,'' Washington, DC: National Academies Press;
2005. pp. 269-423.
    10. * National Heart, Lung, and Blood Institute. ``Managing
Overweight and Obesity in Adults: Systematic Evidence Review from
the Obesity Expert Panel, 2013.'' Retrieved from: https://www.nhlbi.nih.gov/sites/default/files/media/docs/obesity-evidence-review.pdf.
    11. * Centers for Disease Control and Prevention. NCHS health E-
stats. Retrieved from: https://stacks.cdc.gov/view/cdc/58670 and
https://stacks.cdc.gov/view/cdc/58669.
    12. * HHS and USDA. ``Dietary Guidelines for Americans, 2005.''
6th Edition, Washington, DC: U.S. Government Printing Office,
January 2005. Retrieved from: https://health.gov/sites/default/files/2020-01/DGA2005.pdf.
    13. * FDA. ``Public Meeting to Discuss Use of the Term
``Healthy'' in Food Labeling.'' Docket FDA-2016-D-2335. Retrieved
from: https://www.fda.gov/food/newsevents/workshopsmeetingsconferences/ucm539060.htm.
    14. * USDA. A Brief History of USDA Food Guides. Retrieved from:
https://www.choosemyplate.gov/brief-history-usda-food-guides.
    15. * USDA and HHS. ``Dietary Guidelines for Americans, 2010,''
7th Ed., Washington DC: U.S. Government Printing Office, January
2010. Retrieved from: https://health.gov/dietaryguidelines/DGA2010/DietaryGuidelines2010.pdf.
    16. * Dietary Guidelines Advisory Committee. 2020. Scientific
Report of the 2020 Dietary Guidelines Advisory Committee: Advisory
Report to the Secretary of Agriculture and the Secretary of Health
and Human Services. U.S. Department of Agriculture, Agricultural
Research Service, Washington, DC. Retrieved from: https://www.dietaryguidelines.gov/2020-advisory-committee-report.
    17. * The National Academies of Sciences, Engineering, and
Medicine: Health and Medicine Division. ``Review of the Dietary
Reference Intakes for Sodium and Potassium.'' Retrieved from: http://nationalacademies.org/hmd/Activities/Nutrition/ReviewDRIforSodiumandPotassium.aspx.
    18. Antman, E.M., L.J. Appel, D. Balentine, R.K. Johnson, et al.
``Stakeholder Discussion to Reduce Population-Wide Sodium Intake and
Decrease Sodium in the Food Supply: A Conference Report from the
American Heart Association Sodium Conference 2013 Planning Group.''
Circulation. 2014 Jun 24;129(25):e660-79. doi:10.1161/
CIR.0000000000000051.
    19. * FDA. ``Use of the Term ``Healthy'' in the Labeling of
Human Food Products: Guidance for Industry.'' September 2016.
Retrieved from: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf.
    20. * USDA, Agricultural Research Service, Nutrient Data
Laboratory. USDA National Nutrient Database for Standard Reference,
Legacy. Version Current: April 2018. Retrieved from: https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/nutrient-data-laboratory/docs/usda-national-nutrient-database-for-standard-reference/.
    21. * Dietary Guidelines Advisory Committee. 2020. Scientific
Report of the 2020 Dietary Guidelines Advisory Committee: Advisory
Report to the Secretary of Agriculture and the Secretary of Health
and Human Services--Food Pattern Modeling Supplements. U.S.
Department of Agriculture, Agricultural Research Service,
Washington, DC. Retrieved from: https://www.dietaryguidelines.gov/2020-advisory-committee-report/food-pattern-modeling.
    22. Coates, A.M., A.M. Hill, and S.Y. Tan. ``Nuts and
Cardiovascular Disease Prevention.'' Current Atherosclerosis
Reports, 20:48, 2018. Retrieved from: https://doi.org/10.1007/s11883-018-0749-3.
    23. IOM of the National Academies. ``Dietary Reference Intakes
for Water, Potassium, Sodium, Chloride, and Sulfate, Chapter 4:
Water,'' Washington, DC: National Academies Press; 2005.
    24. Popkin, B.M., K.E. D'Anci, and I.H. Rosenberg. ``Water,
Hydration and Health.'' Nutrition Reviews, 68(8):439-458, 2010.
doi:10.1111/j.1753-4887.2010.00304.x.
    25. * Centers for Disease Control and Prevention. Division of
Nutrition, Physical Activity, and Obesity. ``Get the Facts: Drinking
Water and Intake.'' Retrieved from: https://www.cdc.gov/nutrition/data-statistics/plain-water-the-healthier-choice.html.
    26. * FDA. Regulatory Impact Analysis for Proposed Rule:
Nutrient Content Claims; Definition of Term ``Healthy.'' 2018.
Retrieved from: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
    27. Ostchega, Y., C.D. Fryar, T. Nwankwo, and D.T. Nguyen.
Hypertension Prevalence

Among Adults Aged 18 and Over: United States, 2017-2018. NCHS Data
Brief, no 364. Hyattsville, MD: National Center for Health
Statistics. 2020. Retrieved from: https://www.cdc.gov/nchs/data/databriefs/db364-h.pdf.
    28. Centers for Disease Control and Prevention. National
Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease
Control and Prevention, U.S. Dept of Health and Human Services;
2020. Retrieved from: https://www.cdc.gov/diabetes/data/statistics-report/index.html.
    29. Government Accountability Office, Chronic Health
Conditions--Federal Strategy Needed to Coordinate Diet-Related
Efforts. August 17, 2021. Retrieved from: https://www.gao.gov/products/gao-21-593.
    30. * Questions and Answers on FDA's Fortification Policy,
Guidance for Industry. 2015. Retrieved from: https://www.fda.gov/media/94563/download.
    31. * FDA. Sodium Reduction. Retrieved from: www.fda.gov/SodiumReduction.
    32. Facts Up Front. Retrieved from: http://www.factsupfront.org/.
    33. Bitok, E. and J. Sabate. ``Nuts and cardiovascular
disease.'' Progress in Cardiovascular Diseases, 61(1):33-37, 2018.
doi: 10.1016/j.pcad.2018.05.003.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and record keeping
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, FDA
proposes to amend 21 CFR part 101 as follows:

PART 101--FOOD LABELING

0
1. The authority citation for part 101 continues to read as follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
0
2. Revise Sec.  101.13(b)(2)(ii) to read as follows:

Sec.  101.13  Nutrient content claims--general principles.

* * * * *
    (b) * * *
    (2) * * *
    (ii) Suggests that a food, because of its nutrient content, may be
useful in maintaining healthy dietary practices, where there is also
implied or explicit information about the nutrition content of the food
(e.g., healthy).
* * * * *
0
3. Revise Sec.  101.65(d) to read as follows:

Sec.  101.65  Implied nutrient content claims and related label
statements.

* * * * *
    (d) General nutritional claims. (1) This paragraph (d) covers
labeling claims that are implied nutrient content claims because they
suggest that a food may help consumers maintain healthy dietary
practices due to its nutrient content, where there is also implied or
explicit information about the nutrition content of the food.
    (2) For purposes of this section, a ``food group equivalent'' is
the minimum amount of a food group that must be contained in a food for
it to bear the ``healthy'' implied nutrient content claim. Food group
equivalents identify the amounts of foods from each food group with
qualifying nutritional content. A food group equivalent is equal to the
following:

------------------------------------------------------------------------
                                   Food group
         Food group                equivalent             Examples
------------------------------------------------------------------------
(i) Vegetable...............  \1/2\ cup equivalent  \1/2\ cup cooked
                               vegetable.            green beans; 1 cup
                                                     raw spinach.
(ii) Fruit..................  \1/2\ cup equivalent  \1/2\ cup
                               fruit.                strawberries; \1/2\
                                                     cup 100% orange
                                                     juice; \1/4\ cup
                                                     raisins.
(iii) Grains................  No less than \3/4\    1 slice of bread; \1/
                               oz equivalent whole   2\ cup cooked brown
                               grain.                rice.
(iv) Dairy..................  \3/4\ cup equivalent  6 oz fat free
                               dairy.                yogurt; 1\1/8\ oz
                                                     nonfat cheese.
(v) Protein foods...........  1\1/2\ oz equivalent  1\1/2\ oz venison.
                               game meat.           1 oz tuna.
                              1 oz equivalent       1 large egg.
                               seafood.             \1/4\ cup black
                              1 oz equivalent egg.   beans.
                              1 oz equivalent       \1/2\ oz walnuts.
                               beans, peas, or soy
                               products.
                              1 oz equivalent nuts
                               and seeds.
------------------------------------------------------------------------

    (3) You may use the term ``healthy'' or related terms (e.g.,
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,''
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as
an implied nutrient content claim on the label or in labeling of a food
that is useful in creating a diet that is consistent with dietary
recommendations if the food meets one or more of the criteria in
paragraphs (d)(3)(i) through (vi) of this section:
    (i) A raw, whole fruit or vegetable.
    (ii) An individual food that meets the following conditions per
reference amount customarily consumed per eating occasion (RACC):

----------------------------------------------------------------------------------------------------------------
                                                      The added sugars      The sodium
                                 It must contain at   content must be    content must be     The saturated fat
      If the food is . . .           least . . .     no greater than .  no greater than .    content must be no
                                                            . .                . .           greater than . . .
----------------------------------------------------------------------------------------------------------------
(A) A vegetable product........  1/2 c-eq vegetable              0% DV             10% DV  5% DV.
(B) A fruit product............  1/2 c-eq fruit....              0% DV             10% DV  5% DV.
(C) A grain product............  \3/4\ oz                        5% DV             10% DV  5% DV.
                                  equivalent whole
                                  grain.
(D) A dairy product............  \3/4\ cup                       5% DV             10% DV  10% DV.
                                  equivalent dairy.
(E) Protein Foods
    (1) Game meats.............  1\1/2\ oz                       0% DV             10% DV  10% DV.
                                  equivalent.
    (2) Seafood................  1 oz equivalent...              0% DV             10% DV  10% DV.
    (3) Egg....................  1 oz equivalent...              0% DV             10% DV  10% DV.
    (4) Beans, peas, and soy     1 oz equivalent...              0% DV             10% DV  5% DV.
     products.
    (5) Nuts and seeds.........  1 oz equivalent...              0% DV             10% DV  5% DV, excluding
                                                                                saturated fat
                                                                                derived from nuts
                                                                                and seeds.
(F) Oils

    (1) 100% Oil...............  ..................              0% DV              0% DV  20% of total fat.
    (2) Oil-based spreads whose  ..................              0% DV              5% DV  20% of total fat.
     fats come solely from oil.
    (3) Oil-based dressing       ..................              2% DV              5% DV  20% of total fat.
     containing at least 30%
     oil and oils meet the
     requirements in paragraph
     (d)(3)(ii)(F)(1) of this
     section.
----------------------------------------------------------------------------------------------------------------

    (iii) A mixed product that:
    (A) Contains at least half a food group equivalent each of two
different food groups as specified in paragraph (d)(2) of this section;
and
    (B) Meets the following conditions per RACC:

----------------------------------------------------------------------------------------------------------------
                                                                                Excluding saturated fat content
                                           The added sugars      The sodium          from nuts and seeds (if
If the mixed product contains at least .   content must be    content must be    applicable), the saturated fat
                   . .                    no greater than .  no greater than .   content must be no greater than
                                                 . .                . .                       . . .
----------------------------------------------------------------------------------------------------------------
(1) \1/2\ food group equivalent each of               0% DV             10% DV  5% DV; or 7\1/2\% DV if the
 two of the following: fruit, vegetable,                                         protein is a game meat,
 and/or protein.                                                                 seafood, or egg.
(2) \1/2\ food group equivalent of whole         2\1/2\% DV             10% DV  5% DV; or 7\1/2\% DV if the
 grain and \1/2\ food group equivalent                                           protein is a game meat,
 of fruit, vegetable, or protein.                                                seafood, or egg.
(3) \1/2\ food group equivalent of dairy         2\1/2\% DV             10% DV  7\1/2\% DV; or 10% DV if the
 and \1/2\ food group equivalent of                                              protein is a game meat,
 fruit, vegetable, or protein.                                                   seafood, or egg.
(4) \1/2\ food group equivalent of dairy              5% DV             10% DV  7\1/2\% DV.
 and \1/2\ food group equivalent of
 whole grain.
----------------------------------------------------------------------------------------------------------------

    (iv) A main dish product as defined in Sec.  101.13(m) that:
    (A) Contains at least one full food group equivalent each of two
different food groups as specified in paragraph (d)(2) of this section;
and
    (B) Meets the following conditions per labeled serving:

----------------------------------------------------------------------------------------------------------------
                                                                                Excluding the saturated fat
                                           The added sugars      The sodium      content from nuts and seeds (if
  If the main dish product contains at     content must be    content must be    applicable), the saturated fat
               least . . .                no greater than .  no greater than .   content must be no greater than
                                                 . .                . .                       . . .
----------------------------------------------------------------------------------------------------------------
(1) A food group equivalent each of two               0% DV             20% DV  10% DV; or 15% DV if the protein
 of the following: fruit, vegetable, and/                                        is a game meat, seafood, or
 or protein.                                                                     egg.
(2) A food group equivalent of whole                  5% DV             20% DV  10% DV; or 15% DV if the protein
 grain and a food group equivalent of                                            is a game meat, seafood, or
 fruit, vegetable, or protein.                                                   egg.
(3) A food group equivalent of dairy and              5% DV             20% DV  15% DV; or 20% DV if the protein
 a food group equivalent of fruit,                                               is a game meat, seafood, or
 vegetable, or protein.                                                          egg.
(4) A food group equivalent of dairy and             10% DV             20% DV  15% DV.
 a food group equivalent of whole grain.
----------------------------------------------------------------------------------------------------------------

    (v) A meal product as defined in Sec.  101.13(l) that:
    (A) Contains at least one full food group equivalent each of three
different food groups as specified in paragraph (d)(2) of this section;
and
    (B) Meets the following conditions per labeled serving:

----------------------------------------------------------------------------------------------------------------
                                                                                Excluding the saturated fat
                                           The added sugars      The sodium      content from nuts and seeds (if
 If the meal product contains at least .   content must be    content must be    applicable), the saturated fat
                   . .                    no greater than .  no greater than .   content must be no greater than
                                                 . .                . .                       . . .
----------------------------------------------------------------------------------------------------------------
(1) A food group equivalent each of                   0% DV             30% DV  15% DV; or 20% DV if the protein
 fruits, vegetables, and protein foods.                                          is a game meat, seafood, or
                                                                                egg.
(2) A food group equivalent of whole                  5% DV             30% DV  15% DV; or 20% DV if the protein
 grain and a food group equivalent each                                          is a game meat, seafood, or
 of fruit, vegetable, and/or protein.                                            egg.

(3) A food group equivalent of dairy and              5% DV             30% DV  20% DV; or 25% DV if the protein
 a food group equivalent each of fruit,                                          is a game meat, seafood, or
 vegetable, and/or protein.                                                      egg.
(4) A food group equivalent of dairy, a              10% DV             30% DV  20% DV; or 25% DV if the protein
 food group equivalent of whole grain,                                           is a game meat, seafood, or
 and a food group equivalent of fruit,                                           egg.
 vegetable, and/or protein.
----------------------------------------------------------------------------------------------------------------

    (vi) Plain water and plain carbonated water without any flavoring
or additional ingredients.
    (4) Each manufacturer of a food (other than raw, whole fruits, raw
whole vegetables, water, and individual foods where the standard
information required on the food label, such as the list of
ingredients, provides sufficient information to verify that the food
meets the food group equivalent requirements to bear the claim) that
bears the implied nutrient content claim ``healthy'' must make and keep
written records (e.g., analyses of databases, recipes, formulations,
information from recipes or formulations, or batch records) to verify
that the food meets the food group equivalent requirements of paragraph
(d)(2) of this section where the food group equivalent contained in the
product is not apparent from the label of the food. These records must
be kept for a period of at least 2 years after introduction or delivery
for introduction of the food into interstate commerce. Such records
must be provided to FDA upon request, during an inspection, for
official review and photocopying or other means of reproduction.
Records may be kept either as original records, true copies (such as
photocopies, pictures, scanned copies, microfilm, microfiche, or other
accurate reproductions of the original records), or electronic records
which must be kept in accordance with part 11 of this chapter. These
records must be accurate, indelible, and legible.

    Dated: September 22, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-20975 Filed 9-28-22; 8:45 am]
BILLING CODE 4164-01-P