[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Proposed Rules]
[Pages 59168-59202]
[FR Doc No: 2022-20975]

Vol. 87

Thursday,

No. 188

September 29, 2022

Part II

Department of Health and Human Services

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 Food and Drug Administration

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21 CFR Part 101

Food Labeling: Nutrient Content Claims; Definition of Term ``Healthy'';
Proposed Rule

Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-2335]
RIN 0910-AI13

Food Labeling: Nutrient Content Claims; Definition of Term
``Healthy''

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
update the definition for the implied nutrient content claim
``healthy'' to be consistent with current nutrition science and Federal
dietary guidance, especially the Dietary Guidelines for Americans
(Dietary Guidelines), regarding how consumers can maintain healthy
dietary practices. This action, if finalized, will revise the
requirements for when the term ``healthy'' can be used as an implied
claim in the labeling of human food products to indicate that a food's
level of nutrients may help consumers maintain healthy dietary
practices by helping them achieve a total diet that conforms to dietary
recommendations.

DATES: Either electronic or written comments on the proposed rule must
be submitted by December 28, 2022. Submit written comments (including
recommendations) on the collection of information under the Paperwork
Reduction Act of 1995 (PRA) by October 31, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 28, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2335 for ``Food Labeling: Nutrient Content Claims;
Definition of Term `Healthy.' '' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    Submit comments on information collection under the Paperwork
Reduction Act of 1995 to the Office of Management and Budget (OMB) at
https://www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function. The title of this
proposed collection is ``Food Labeling Regulations,'' OMB control
number 0910-0381.

FOR FURTHER INFORMATION CONTACT:
    With regard to the proposed rule: Vincent de Jesus, Center for Food
Safety and Applied Nutrition, HFS-830, Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>,
[email protected]; or Denise See, Center for Food Safety and
Applied Nutrition, Office of Regulations and Policy (HFS-024), Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2378.
    With regard to the information collection: Domini Bean, FDA PRA
Staff, Office of Operations, Food and Drug Administration, Three White
Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852,
301-796-5733, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority

    D. Costs and Benefits
II. Introduction
III. Table of Abbreviations/Commonly Used Acronyms in This Document
IV. Background
    A. Regulatory History
    B. Need To Update ``Healthy''
    C. Actions Taken To Update ``Healthy''
    D. Table of Past Publications Referenced in This Proposed Rule
V. Legal Authority
VI. Proposed Action
    A. Overview of Approach
    B. Description of Proposed Regulation
VII. Proposed Effective and Compliance Dates
VIII. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. Consultation and Coordination With Indian Tribal Governments
XIII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    Consumers rely on food labels when navigating the marketplace to
make informed choices about the foods that are the foundation of a
nutritious diet for both themselves and members of their families. FDA
plays an important role in ensuring labels of food for human
consumption are accurate, truthful, and not misleading, including
claims that appear in product labeling to market a food. One such claim
that FDA has regulated is the term ``healthy'' on product labels. Since
1994, we have recognized that when a manufacturer uses labeling that
describes a product as ``healthy'' in the nutritional context, it is
making an implicit claim of the level of nutrients of the product. In
particular, such a label implies that the nutrient content of the food
may help consumers maintain healthy dietary practices. Given that
nutrition science has evolved since the 1990s when FDA first
established a definition for the implied nutrient content claim
``healthy,'' the proposed rule would update the definition for the
implied nutrient content claim ``healthy'' to be consistent with
current nutrition science and Federal dietary guidance. The proposed
rule would revise the requirements for when the claim ``healthy'' can
be used as an implied nutrient content claim in the labeling of human
food products. In particular, because the claim indicates that a food,
because of its nutrient content, may help consumers maintain healthy
dietary practices, we seek to limit the use of the claim to
circumstances in which the food may help consumers achieve a healthy
dietary pattern that conforms to current nutrition science and Federal
dietary guidance.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed regulation would update the definition for the implied
nutrient content claim ``healthy,'' which specifies the requirements
for when the claim can be used on human food products. The claim
``healthy,'' when used in the nutritional context in food labeling, is
an implied claim that the levels of the nutrients in the food are such
that the food may help consumers maintain healthy dietary practices.
Under the existing regulation, there are specific criteria for
individual nutrients that must be met in the food for it to bear the
claim, including limits on total fat, saturated fat, cholesterol, and
sodium, and minimum amounts of nutrients whose consumption is
encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and
dietary fiber. Since the time the claim was first defined in 1994,
nutrition science and Federal dietary guidance have changed, making the
current ``healthy'' definition outdated. Our current definition permits
manufacturers to use the claim ``healthy'' on some foods that, based on
the most up-to-date nutrition science and Federal dietary guidance,
contain levels of nutrients that would not help consumers maintain
healthy dietary practices. Further, a number of foods emphasized in
current nutrition science and Federal dietary guidance as key elements
of a healthy dietary pattern are not able to bear the ``healthy'' claim
under the current regulation (e.g., salmon due to fat levels). As a
result, we believe that the definition needs to be updated so that the
use of the claim will again accurately represent that the levels of the
nutrients in the food may help consumers maintain healthy dietary
practices, consistent with current nutrition science and Federal
dietary guidance, as reflected in the Dietary Guidelines for Americans,
2020-2025 (Dietary Guidelines, 2020-2025) (Ref. 1). The proposed
framework for the updated definition of ``healthy'' uses a food group-
based approach in addition to nutrients to limit (based on the
understanding that each food group contributes an array of important
nutrients to the diet). The proposed, updated ``healthy'' criteria
would emphasize healthy dietary patterns by requiring that food
products contain a certain amount of food from at least one of the food
groups or subgroups recommended by the Dietary Guidelines, 2020-2025 in
order to be labeled ``healthy.'' The proposed regulation would also
require a food product to be limited in certain nutrients, including
saturated fat, sodium, and added sugars. The proposed rule would also
add certain recordkeeping requirements for foods bearing the claim
where compliance cannot be verified through information on the product
label.

C. Legal Authority

    We are issuing this proposed rule to update the definition of the
implied nutrient content claim ``healthy'' consistent with our
authority in sections 201(n), 403(a), 403(r), and 701(a) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(n), 343(a),
343(r), and 371(a)). We are also relying on our authority under
sections 403(r), 403(a), 201(n) and 701(a) of the FD&C Act to propose
certain records requirements.

D. Costs and Benefits

    In the current marketplace, about 5 percent of all packaged foods
are labeled as ``healthy.'' Because nutrition science has evolved over
time, updating the definition of the implied nutrient content claim
``healthy'' to closely align with nutrition science underpinning the
Dietary Guidelines, 2020-2025 will better inform consumers who are
selecting those products to choose a more healthful diet, which may
result in lower incidence of diet-related chronic 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 that rely upon the ``healthy''
implied nutrient content claim selecting and consuming more healthful
foods. This is calculated through the negative association between a
Healthy Eating Index score and all-cause mortality. Quantifiable costs
to manufacturers associated with updating the ``healthy'' claim are
reformulating, labeling, and recordkeeping. Discounted at 3 percent
over 20 years, the mean present value of costs is estimated at $276
million, or $19 million annualized. Potential costs of rebranding
certain foods are discussed qualitatively. Discounted at three percent
over 20 years, the mean present value of benefits is estimated at $455
million, or $31 million annualized. Net benefits are estimated at $180
million, or $12 million annualized.

II. Introduction

    In 1994, FDA issued a regulation defining ``healthy'' as an implied
nutrient content claim pursuant to the Nutrition Labeling and Education
Act (NLEA) of 1990. Implied nutrient

content claims were defined in our regulations, in part, as claims that
imply that a food, because of its nutrient content, may help consumers
maintain healthy dietary practices. At that time, nutrition science and
Federal dietary guidance focused more on the individual nutrients
contained in food. As a result, the criteria for ``healthy'' in the
current regulation are solely based on individual nutrients. Nutrition
science and Federal dietary guidance have evolved since the existing
``healthy'' regulation was issued in 1994. As the Dietary Guidelines,
2020-2025 explains, current nutrition science focuses ``on consuming a
healthy dietary pattern'' (Ref. 1). Although nearly all foods can be
incorporated into a healthy dietary pattern to a greater or lesser
extent, current nutrition science emphasizes nutrient-dense foods, such
as fruits, vegetables, and whole grains, as key elements of a healthy
dietary pattern. ``Nutrient dense'' foods and beverages are defined as
foods and beverages that provide vitamins, minerals, and other health-
promoting components and have little added sugars, saturated fat, and
sodium (Ref. 1). These foods, which contain a variety of important
nutrients, work synergistically as part of a dietary pattern to help
improve health (Ref. 1). A number of these nutrient-dense foods are not
able to bear the ``healthy'' claim under the current regulation (e.g.,
salmon due to fat levels). Further, the current definition permits
manufacturers to use the claim ``healthy'' on some foods that, based on
the most up-to-date nutrition science and Federal dietary guidance,
contain levels of nutrients that would not help consumers maintain
healthy dietary practices (e.g., certain ready-to-eat cereals that may
be high in added sugars). Thus, we believe that the ``healthy'' claim
definition needs to be updated in order to ensure that products bearing
the claim are the products that may help consumers maintain healthy
dietary practices, consistent with current nutrition science and
Federal dietary guidance.
    FDA seeks to improve dietary patterns in the United States to help
reduce the burden of nutrition-related chronic diseases and advance
health equity as nutrition-related chronic diseases are experienced
disproportionately by certain racial and ethnic minority groups and
those with lower socioeconomic status. We are committed to
accomplishing this, in part, by empowering consumers with more
informative and accessible labeling to choose healthier diets. By
making nutrition information more available to consumers in a direct,
accessible, and consistent manner, consumers will be able to make
informed and healthful dietary choices. A key element in achieving
these goals is updating our policies for nutrition-related labeling
claims to reflect current nutrition science and Federal dietary
guidance, which includes aligning with the updated Nutrition Facts
Label and the Dietary Guidelines, 2020-2025 (Ref. 1), and provide
information in a way that is accessible to consumers. Claims like
``healthy'' provide information to consumers that allow them to quickly
identify foods that can be the foundation of a healthy dietary pattern.
Thus, the goal of this rulemaking is to update the definition of
``healthy'' as an implied nutrient content claim in the labeling of
human food to help ensure that consumers have access to more complete,
accurate, and up-to-date information about those foods.
    To provide context regarding the scope of the problem Americans
face from diet-related chronic disease, chronic diseases, such as heart
disease, cancer, and stroke, are among the leading causes of death and
disability in the United States, and half of all American adults have
one or more preventable, diet-related chronic diseases, including
cardiovascular disease and type 2 diabetes (Ref. 2). Each year, more
than 630,000 Americans die from heart disease and close to 600,000 die
from cancer (Ref. 3). An estimated 37 percent of Americans suffer from
cardiovascular disease (CVD) (Ref. 4). As of 2017, 12.2 percent of the
population 18 years and older had diabetes, 33.9 percent of adults had
prediabetes (Ref. 5), and 38.4 percent of the population was predicted
to be diagnosed with cancer during their lifetime (Ref. 6). As noted,
many of these chronic diseases are experienced at higher rates by
certain racial and ethnic minority groups and those with lower
socioeconomic status. For example, in 2017-2018, more than 4 in 10
American adults had high blood pressure, and that number increases to
about 6 in 10 for non-Hispanic Black adults (Ref. 27). Additionally,
from 2017 to 2018, the prevalence of diagnosed diabetes was highest
among American Indian and Alaska Native adults compared to other race-
ethnicity groups (Ref. 28). While chronic diseases result from a mix of
factors, unhealthy dietary patterns throughout the lifespan increase
the risk of developing chronic diseases, along with genetic,
biological, behavioral, socioeconomic, and environmental factors (Ref.
1).
    Further, overweight and obesity, which are associated with poor
eating and physical activity behaviors, are major contributors to
chronic disease in the United States (Ref. 10). Obesity raises the risk
for morbidity from chronic diseases such as type 2 diabetes, coronary
heart disease, and some cancers, and is also associated with increased
risk of all-cause and CVD mortality (Ref. 10). More than two-thirds of
U.S. adults and nearly one-third of children and youth are overweight
or obese (Ref. 11). These high rates of overweight and obesity and
chronic disease have persisted for more than two decades and come not
only with increased health risks, but also at high economic cost.
According to the Government Accountability Office, in 2018, $383.6
billion was spent to treat CVD, cancer, and diabetes, making up 25
percent of the approximately $1.5 trillion in total health care
spending on conditions among U.S. adults. In particular, government
payers, including Medicare and Medicaid, account for more than 50
percent of spending for treatment of CVD, cancer, and diabetes (Ref.
29).
    Improved nutrition represents an opportunity to help reduce the
rates of these diet-related chronic diseases. As part of our nutrition
work, we are taking actions to help consumers maintain healthy dietary
patterns and make food choices that contribute to such patterns. A key
source that has considered the current nutrition science and
established recommendations on what healthy dietary patterns look like
is the Dietary Guidelines document. The Dietary Guidelines are
developed jointly by the U.S. Department of Agriculture (USDA) and the
U.S. Department of Health and Human Services (HHS) and provide
recommendations on healthy eating and the consumption of foods from
various food groups, as well as the intake of specific macronutrients,
such as saturated fats and added sugars, and micronutrients such as
vitamins and minerals. The Dietary Guidelines are designed for
policymakers and nutrition and health professionals to help all
individuals and their families consume a healthy, nutritionally
adequate diet (Ref. 1). The Dietary Guidelines are the foundation of
Federal dietary guidance and are intended to inform policymakers when
they implement Federal policies and programs related to food,
nutrition, and health. The Dietary Guidelines, in addition to other
consensus reports and scientific information, help FDA to shape
regulations on nutrition-related claims

and other information that is permitted on a food label.
    The Dietary Guidelines, 2020-2025 explains that a healthy
lifestyle--including following a healthy dietary pattern--can help
people achieve and maintain good health and reduce the risk of chronic
disease throughout all stages of the lifespan. The Dietary Guidelines,
2020-2025 identifies vegetables, fruits, dairy, grains, protein foods,
and oils as essential components of a healthy dietary pattern (Ref. 1).
However, more than 80 percent of Americans have dietary patterns that
are low in vegetables, fruits, and dairy (Ref. 1). Additionally, more
than half of the population is meeting or exceeding the total grain and
total protein foods recommendations but is not meeting the
recommendations for the subgroups within each of these food groups
(Ref. 1). In 2019, 42 percent of adolescents and 39 percent of adults
said they ate fruit less than once a day, while 41 percent of
adolescents and 21 percent of adults said they ate vegetables less than
once a day (Ref. 13). At the same time, most Americans exceed the
recommended intake limits for added sugars, saturated fats, and sodium,
nutrients that should be limited in a healthy dietary pattern according
to the Dietary Guidelines, 2020-2025 (Ref. 1). Evidence shows that
excess intake of these nutrients is associated with chronic disease
risk; for example, diets lower in saturated fat may reduce the risk of
CVD (Ref. 7), and high intakes of sodium are directly associated with
elevated blood pressure, an important risk factor for CVD (Refs. 9, 10,
and 17).
    As consumers make their food purchases and daily food choices, food
labeling provides them with valuable information about food groups,
nutrients, and how a food from a particular food group fits into their
daily diet. Claims on food packages such as ``healthy'' can provide
quick signals to consumers about the healthfulness of a food or
beverage, making it easier for busy consumers to select foods that can
help build more healthful diets. To be accurate and effective, however,
a claim of ``healthy'' must be based on current nutrition science and
Federal dietary guidance to ensure that the foods bearing the claim in
fact are useful to help consumers maintain healthy dietary practices.
    We are thus proposing to update the implied nutrient content claim
``healthy,'' to make it consistent with current nutrition science and
Federal dietary guidance. This update would modernize the criteria for
the ``healthy'' claim to go beyond just individual nutrients to also
incorporate the variety of nutrients present in a food, through the new
food group requirements. This change would better reflect the overall
nutrient content of the food, including nutrient density, to represent
how nutrients work together and make up the food groups and subgroups
that are part of a healthy dietary pattern. Aligning the concept of
what it means to qualify for the ``healthy'' claim with current
nutrition science and Federal dietary guidance, and its focus on
nutrient density, will help ensure that the ``healthy'' claim is
accurate and empowers consumers with information to make healthier
decisions. Because we understand that there may be some reluctance by
some food manufacturers to use the claim with the current regulatory
definition, as it is not consistent with current nutrition science and
Federal dietary guidance, we also expect that our proposed updated
criteria for the ``healthy'' nutrient content claim may expand the
availability of food labeled with the ``healthy'' claim for consumers
in the marketplace due to manufacturers being more willing to use the
updated claim.

   III--Table of Abbreviations/Commonly Used Acronyms in This Document
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     Abbreviation/acronym                    What it means
------------------------------------------------------------------------
CVD..........................  Cardiovascular Disease.
Dietary Guidelines...........  Dietary Guidelines for Americans.
DV...........................  Daily Value.
DRV..........................  Daily Reference Value.
c-eq.........................  Cup Equivalent.
DRI..........................  Daily Reference Intake.
DGAC.........................  Dietary Guidelines Advisory Committee.
FDA..........................  Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FGE..........................  Food Group Equivalent.
HHS..........................  U.S. Department of Health and Human
                                Services.
G............................  Gram.
IOM..........................  Institute of Medicine.
OMB..........................  Office of Management and Budget.
National Academies...........  National Academies of Sciences,
                                Engineering, and Medicine.
NFL Final Rule...............  Food Labeling: Revision of the Nutrition
                                and Supplement Facts Labels, Final Rule.
NLEA.........................  Nutrition Labeling and Education Act.
oz-eq........................  Ounce Equivalent.
Mg...........................  Milligram.
Oz...........................  Ounce.
PRA..........................  Paperwork Reduction Act.
RDI..........................  Reference Daily Intake.
RACC.........................  Reference Amount Customarily Consumed.
RFI..........................  Request for Information.
PHO..........................  Partially Hydrogenated Oil.
USDA.........................  U.S. Department of Agriculture.
Dietary Guidelines, 2020-2025  Dietary Guidelines for Americans, 2020-
                                2025.
2020 DGAC Report.............  Scientific Report of the 2020 Dietary
                                Guidelines Advisory Committee.
------------------------------------------------------------------------

IV. Background

A. Regulatory History

    In the Federal Register of May 10, 1994, we published a final rule
entitled ``Food Labeling: Nutrient Content Claims, Definition of Term:
Healthy'' amending Sec.  101.65(d) to define the term ``healthy'' as an
implied nutrient content claim under section 403(r) of the FD&C Act (59
FR 24232). The definition in Sec.  101.65(d) establishes parameters for
use of the implied nutrient content claim ``healthy'' or related terms
(such as ``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,''
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') on
the label or in the labeling of a food that is useful in creating a
diet that is consistent with dietary recommendations, if the food meets
certain nutrient conditions. Under the existing regulation, these
conditions include specific criteria for nutrients that must be met in
the food for it to bear such claims. These criteria include limits on
total fat, saturated fat, cholesterol, and sodium, and minimum amounts
(10 percent of Daily Value (DV)) of nutrients whose consumption is
encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and
dietary fiber. Under the regulation, foods must meet all limits and
contain the minimum amount of at least one nutrient to encourage to
bear the ``healthy'' claim. The required nutrient criteria vary for
certain food groups (e.g., there are different criteria for seafood,
game meat, and raw fruits and vegetables) (Sec.  101.65(d)(2)). The
current claim is also linked to use with an explicit or implicit claim
or statement about a nutrient (e.g., ``healthy, contains 3 grams of
fat'').

B. Need To Update ``Healthy''

    The existing definition in Sec.  101.65(d) is linked to certain
requirements in the Nutrition Facts label at 21 CFR 101.9 and serving
size regulations at 21 CFR 101.12 that were in effect in 1994 when the
final rule to define the nutrient content claim ``healthy'' was
published. For example, the existing ``healthy'' regulation requires
that a product provide a specified percentage of the RDI or Daily
Reference Value (DRV) for nutrients that were of ``sufficient public
health significance to warrant their inclusion on the nutrition label''
(59 FR 24232). Since that time, FDA has issued final rules updating the
Nutrition Facts label and serving size information for packaged foods
to reflect new scientific information. This includes the final rules
``Food Labeling: Revision of the Nutrition and Supplement Facts
Labels'' (81 FR 33742, ``NFL Final Rule'') and ``Food Labeling: Serving
Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion;
Dual-Column Labeling; Updating, Modifying, and Establishing Certain
Reference Amounts Customarily Consumed; Serving Size for Breath Mints;
and Technical Amendments'' (81 FR 34000, ``Serving Size Final Rule''),
which were published on May 27, 2016. These rules included changes to
the nutrients that must be declared on the Nutrition Facts label. For
example, the Nutrition Facts label must now include a declaration of
the amount of added sugars in a serving of a product, based on our
conclusion that evidence on dietary patterns and health outcomes
supports a mandatory declaration of added sugars (81 FR 33742 at
33799). The updates also included changes to the DV of certain
individual nutrients to reflect changes in recommended intake levels
based on current nutrition science. The Nutrition Facts label
declaration requirements and DVs for individual nutrients significantly
inform the regulations for nutrient content claims such as ``healthy,''
including the updated criteria outlined in this proposed rule. The NFL
Final Rule and the Serving Size Final Rule reflect the nutrition
science in the 2015-2020 Dietary Guidelines, other consensus reports,
national survey intake data, and research regarding consumer use and
understanding of the label.
    The Dietary Guidelines are published every five years to reflect
current nutrition science. Although some of its specific
recommendations have evolved as scientific knowledge has grown, many of
its foundational recommendations have remained consistent over time
(e.g., recommending increased consumption of fruits, vegetables, and
whole grains, and diets low in saturated fat and sodium). Advancements
in nutrition science have provided a greater understanding of, and
focus on, the importance of healthy dietary patterns, and how dietary
components act synergistically to affect health. The Dietary
Guidelines, 2020-2025 has a particular focus on the importance of
dietary patterns as a whole, with recommendations to help Americans
make choices from across and within all food groups within calorie
needs to add up to an overall healthy dietary pattern (Ref. 1). The
Dietary Guidelines, 2020-2025 also emphasizes ``shifts,'' or
replacement of less healthy food choices with nutrient-dense foods, as
a method for consumers to achieve a healthy dietary pattern. The body
of scientific evidence discussed in the Dietary Guidelines, 2020-2025,
and the recommendations based on that nutrition science, inform this
proposed rule.
    As stated above, a key element in helping to reduce the burden of
nutrition-related chronic diseases and advance health equity is
updating FDA's policies for nutrition-related labeling claims to ensure
that they reflect current nutrition science and Federal dietary
guidance, and provide information in ways that are useful and easier to
understand for consumers. Because the implied nutrient content claim
``healthy,'' as codified at Sec.  101.65(d)(2), is linked to the
nutrition labeling regulations and dietary guidance that were in effect
at the time of its issuance in 1994, we propose to update the criteria
for ``healthy'' to ensure they are harmonized with current regulations,
nutrition science, and Federal dietary guidance.
    The framework underlying the existing ``healthy'' claim is, in some
respects, inconsistent with current nutrition science and Federal
dietary guidance. For example, the Dietary Guidelines, 2020-2025, which
reflects current nutrition science, is centered on the importance of
dietary patterns; their recommendations focus on the combination of
nutrient-dense foods and beverages that people should consume to meet
nutritional needs within calorie limits (Ref. 1), rather than focusing
on individual nutrients. Nutrient density is important, among other
reasons, because consumption of nutrient-dense foods provides
beneficial nutrients, with little added sugars, saturated fat, or
sodium. In contrast, the existing criteria for ``healthy'' only include
requirements for individual nutrients. Under the solely individual
nutrient-based framework, foods that are encouraged by the Dietary
Guidelines, 2020-2025 for inclusion in a healthy dietary pattern are
sometimes not able to meet the nutrient criteria under Sec.  101.65(d)
for use of the claim ``healthy.'' For example, although consumption of
certain oils, such as olive and canola oil, in place of sources of
saturated fat, is supported by current nutrition science and emphasized
by Federal dietary guidance (such as the Dietary Guidelines, 2020-2025)
as part of a healthy dietary pattern, these oils are currently
ineligible to bear the ``healthy'' claim, in part, because they do not
contain 10 percent of the DV for vitamin A, vitamin C, protein, dietary
fiber, calcium, or iron as specified by the existing rule. Thus, the
existing ``healthy'' claim has become inconsistent with the
longstanding

purpose of this type of implied claim to indicate that the nutrient
levels in a food may help consumers maintain healthy dietary practices.
    To the extent that current nutrition science and Federal dietary
guidance (such as the Dietary Guidelines, 2020-2025) do still focus on
individual nutrients (e.g., recommending limits on saturated fat,
sodium, and added sugars; identifying certain underconsumed nutrients),
there have been some developments in scientific understanding related
to intake of such nutrients. For example, Federal dietary guidance has
shifted from recommending diets low in total fat (Ref. 12) to
emphasizing increased intakes of monounsaturated and polyunsaturated
fats and decreased intakes of saturated fat (Ref. 1). Additionally,
current nutrition science, as reflected in the Dietary Guidelines,
2020-2025, recommends limiting consumption of foods higher in added
sugars, which provide excess calories to the diet without contributing
significant amounts of essential nutrients. In contrast, the existing
``healthy'' criteria include limits on total fat and do not include
limits for added sugars, which makes the criteria inconsistent with
current nutrition science and Federal dietary guidance.
    Finally, as noted above, the existing definition for healthy
includes a nutrient contribution criterion focused on nutrients that
had sufficient public health significance to warrant their inclusion on
the nutrition label and that had been highlighted by leading health
authorities as being important to the public health (59 FR 24232 at
24243). At the time the existing ``healthy'' regulation was finalized
in 1994, the nutrients included in the nutrient contribution
requirement were vitamin A, vitamin C, protein, iron, calcium, and
dietary fiber. Nutrient intakes have shifted over time, and vitamins A
and C are no longer considered nutrients of public health significance
because deficiency of these nutrients in the U.S. population is rare
and not currently of substantial public health concern. In our recent
updates to the Nutrition Facts label, we required declaration of
vitamin D and potassium, but no longer required declaration of vitamins
A and C (81 FR 33742 at 33744). These updates are consistent with the
Dietary Guidelines, 2020-2025, which includes calcium, potassium,
dietary fiber, and vitamin D as nutrients of public health concern, in
addition to iron, for certain population groups (Ref. 1). Thus, in
addition to a shift in focus from consumption of individual nutrients
to healthy dietary patterns as the primary way to achieve nutritional
adequacy, there have been some changes in Federal dietary guidance
regarding individual nutrients since the original ``healthy'' rule was
issued.
    Noting the changes to the Nutrition Facts label, current nutrition
science, and the Dietary Guidelines, 2020-2025, a variety of
stakeholders, including from academia, industry, and consumers, have
requested that we update the implied nutrient content claim
``healthy.'' Some stakeholders have provided specific recommendations
on how they believe we should approach such an update. For example, in
a citizen petition dated December 1, 2015 (Docket No. FDA-2015-P-4564)
(``Kind Citizen Petition''), KIND LLC requested that we make certain
changes to existing nutrition claim regulations, including a number of
changes specifically related to the nutrient content claim ``healthy.''

C. Actions Taken To Update ``Healthy''

    Because the framework for many of our nutrition labeling
regulations is linked to elements in the Nutrition Facts label and
serving size regulations, we have already taken several steps toward
harmonizing the ``healthy'' nutrient content claim with our updated
regulations and current nutrition science. In the Federal Register of
September 28, 2016 (81 FR 66527), we published a notice of availability
of a final guidance entitled ``Use of the Term `Healthy' in the
Labeling of Human Food Products: Guidance for Industry.'' The guidance
describes our intent to reevaluate the existing criteria for
``healthy'' in light of the changes to the Nutrition Facts label and
serving size regulations, as well as the changes in nutrition science
as reflected in the Dietary Guidelines. The guidance also advises
manufacturers of our intention to exercise enforcement discretion with
respect to some of the existing criteria for the nutrient content claim
``healthy'' until we amend Sec.  101.65(d)(2). The guidance is
available at: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf.
    Specifically, the guidance advises food manufacturers of our intent
to exercise enforcement discretion with respect to the implied nutrient
content claim ``healthy'' for foods that have a fat profile of
predominantly monounsaturated and polyunsaturated fats, but do not meet
the regulatory definition of ``low fat,'' and on foods that contain at
least 10 percent of the DV per reference amount customarily consumed
(RACC) \1\ of potassium or vitamin D. This guidance reflects the
changes in science and the Dietary Guidelines as described above
related to intake of dietary fat and the changes in the nutrients of
public health concern since the ``healthy'' definition was originally
issued.
---------------------------------------------------------------------------

    \1\ Our regulations at Sec.  101.12(b) establish RACCs for
specified product categories that manufacturers can use to determine
the required label serving size.
---------------------------------------------------------------------------

    In September 2016, we also announced the establishment of a docket
(Docket No. FDA-2016-D-2335) to receive information and comments
(request for information or RFI) on the use of the term ``healthy'' in
the labeling of human food products (81 FR 66562, September 28, 2016).
In the RFI, we invited interested persons to comment on the Kind
Citizen Petition; the use of the term ``healthy'' as a nutrient content
claim in the labeling of human food products; and when, if ever, the
use of the term ``healthy'' may be false or misleading. We also sought
input on 12 specific questions and asked interested parties to provide
supporting data, consumer research, and other information to support
their comments and answers to our questions. Along with the RFI, we
held a public meeting on March 9, 2017, entitled ``Use of the Term
`Healthy' in the Labeling of Human Food Products'' (Ref. 13). The
purpose of the public meeting was to give interested persons an
opportunity to discuss the use of the term ``healthy'' in the labeling
of human food.
    Overall, the comments to the docket (nearly 1,200) and at the
public meeting supported updating the criteria for the ``healthy''
nutrient content claim to reflect current nutrition science and the
Dietary Guidelines. Most health organizations, industry
representatives, and consumers supported an enforceable, specific
definition that would help guide consumers toward healthier options.
There was broad support for limiting certain nutrients, especially
added sugars, in foods labeled ``healthy,'' and in allowing whole,
nutrient-dense foods and foods high in monounsaturated and
polyunsaturated fats to meet the definition. Comments to the docket
provided specific recommendations for nutrient criteria, whole food
servings, and flexibility for different food categories. While there
was some variation in the specific criteria proposed in comments,
virtually all of the proposed frameworks included a combination of
nutrient criteria and food group requirements.
    Some comments from consumers, and a few comments from industry and

health organizations, expressed hesitation at the notion of a
``healthy'' nutrient content claim. Their primary concerns were that
``healthy'' could be too simplistic, could deter consumers from looking
further into a product's nutritional content, could lead to excessive
consumption of ``healthy'' products, or could mean different things to
different consumers (e.g., some consumers may not understand
``healthy'' in a nutritional context, but, rather, as referring to
other aspects of the product, such as its production method (e.g.,
organic)). FDA notes that the claim is not new and has been used on
food product labels for decades, but we welcome additional comments on
these issues in the context of this proposed rule.
    We carefully considered comments received in response to the RFI
and are addressing many aspects of the concerns noted within those
comments in this proposed rule. We view the ``healthy'' claim as an
opportunity to signal and provide information to consumers on which
food products, because of their nutrient content, can be most helpful
in maintaining healthy dietary practices, based on current nutrition
science and Federal dietary guidance. The availability of a revised,
updated ``healthy'' claim may also result in some members of the food
industry developing and/or reformulating food products to better match
current nutrition science recommendations and use the claim. Given the
widespread support for updating ``healthy'' along with the need to
align the claim with current nutrition science, we are proposing
updated criteria for the claim.

D. Table of Past Publications Referenced in This Proposed Rule

----------------------------------------------------------------------------------------------------------------
                       Title                                       Publication date                  Citation
----------------------------------------------------------------------------------------------------------------
Food Labeling: Nutrient Content Claims, General      January 6, 1993............................      58 FR 2302
 Principles, Petitions, Definition of Terms Final
 Rule.
Food Labeling: Nutrient Content Claims, Definition   May 10, 1994...............................     59 FR 24232
 of Term: Healthy Final Rule.
Food Labeling: Revision of the Nutrition and         May 27, 2016...............................     81 FR 33742
 Supplement Facts Labels Final Rule.
Food Labeling: Serving Sizes of Foods That Can       May 27, 2016...............................     81 FR 34000
 Reasonably Be Consumed at One Eating Occasion;
 Dual-Column Labeling; Updating, Modifying, and
 Establishing Certain Reference Amounts Customarily
 Consumed; Serving Size for Breath Mints; and
 Technical Amendments Final Rule.
Notice of Availability for a Final Guidance ``Use    September 28, 2016.........................     81 FR 66527
 of the Term `Healthy' in the Labeling of Human
 Food Products: Guidance for Industry''.
Request for Information on the Use of the Term       September 28, 2016.........................     81 FR 66562
 ``Healthy'' in the Labeling of Human Food Products.
----------------------------------------------------------------------------------------------------------------

V. Legal Authority

    We are issuing this proposed rule to update the definition of the
implied nutrient content claim ``healthy'' consistent with our
authority in sections 201(n), 403(a), 403(r), and 701(a) of the FD&C
Act. These sections authorize FDA to adopt regulations that prohibit
labeling that is: (1) false and misleading in that it fails to reveal
facts that are material in light of the representations that are made
with respect to consequences that may result from consuming the food or
(2) uses terms to characterize the level of any nutrient in a food that
has not been defined by regulation by FDA.
    Congress passed the Nutrition Labeling and Education Act (NLEA) of
1990 (Pub. L. 101-535), with three basic objectives: (1) to make
available nutrition information that can assist consumers in selecting
foods that can lead to healthier diets, (2) to eliminate consumer
confusion by establishing definitions for nutrient content claims that
are consistent with the terms defined by the Secretary of HHS, and (3)
to encourage product innovation through the development and marketing
of nutritionally improved foods (58 FR 2302, January 6, 1993). The NLEA
created section 403(r)(1)(A) of the FD&C Act, which provides
specifications for a claim made in the label or labeling of the food
which expressly or by implication characterizes the level of any
nutrient which is of the type required by section 403(q)(1) or (q)(2)
to be in the label or labeling of the food. The statute permits the use
of these label and labeling claims that expressly or by implication
characterize the level of any nutrient in a food, but only if the
claims are made in accordance with FDA's authorizing regulations
(section 403(r)(1)(A) & (r)(2)(A) of the FD&C Act). Such claims are
referred to as ``nutrient content claims.''
    Nutrient content claims can either be claims that expressly
characterize the level of a nutrient (express claims, such as ``low
fat'') or claims that by implication characterize the level of any
nutrient (implied claims, like the ``healthy'' claim). Nutrient content
claims are typically based per RACC. This allows nutrient content
claims on foods to be considered consistently across products and
product sizes. In rulemaking to implement section 403(r)(1)(A) and
403(r)(2) of the FD&C Act shortly after the enactment of the NLEA, we
determined that a claim that states that a food, because of its
nutrient content, may be useful in maintaining healthy dietary
practices is a claim that characterizes the levels of nutrients in a
food (``Food Labeling: Nutrient Content Claims, General Principles,
Petitions, Definition of Terms,'' 58 FR 2302 at 2374-75, January 6,
1993). That rulemaking resulted in regulations defining ``implied
nutrient content claims,'' in part, as claims that imply that a food,
because of its nutrient content, may help consumers maintain healthy
dietary practices. As the preamble explained, ``[t]he claims are
essentially saying that the levels of nutrients in the food are such
that the food will contribute to good health'' (58 FR 2302 at 2375).
    FDA issued another implementing regulation in 1994, in which we
defined ``healthy'' when the term is used as an implied nutrient
content claim (59 FR 24232, May 10, 1994). We explained in the preamble
to the 1994 final rule that the statute requires that FDA define terms
by regulation before they are used as nutritional claims in food
labeling; more specifically, under the terms of section 403(r)(1)(A)
and 403(r)(2) of the FD&C Act, a nutrient content claim would misbrand
a food unless it is made in accordance with a definition of the
Secretary (and, by delegation, FDA) or with one of the other provisions
in section 403(r)(2) of the FD&C Act (59 FR 24232 at 24234). The
preamble explained that FDA had already determined that, when used in
the nutritional labeling context, the term ``healthy'' is making an
implied claim about the levels of the nutrients in the food; that is,
that these levels are such that the food would be useful in achieving a
total diet that conforms to current dietary recommendations (56 FR
60421 at 60423, November 27, 1991). Accordingly, FDA was establishing a

definition for ``healthy'' when it is used in a nutritional context.
    In this rulemaking, we are proposing to update the definition of
``healthy'' when used as an implied nutrient content claim based on
developments in current nutrition science and Federal dietary guidance,
as we did with the rulemaking updating the Nutrition Facts label. Our
proposed, updated criteria for ``healthy'' incorporate both food group
and nutrient-to-limit requirements. These changes are intended to
ensure that foods bearing the implied nutrient content claim
``healthy'' are foods that may help consumers maintain healthy dietary
practices, based on current nutrition science and Federal dietary
guidance. The fundamental purpose of this rulemaking furthers the
congressional objectives underlying the NLEA of providing nutrition
information to consumers to help in selecting foods that can lead to
healthier diets and reducing consumer confusion potentially caused by
the use of inconsistent definitions for nutrient content claims.
    The proposed revised definition of ``healthy'' is consistent with
the statutory language, particularly in light of the way current
nutrition science and Federal dietary guidance, such as the Dietary
Guidelines, have evolved and built upon previous editions. The Dietary
Guidelines reflect the consensus scientific understanding that
nutrients are not consumed in isolation and focus their recommendations
on consuming a variety of nutrient-dense foods, across all food groups,
as part of a healthy dietary pattern. The statutory language describes
nutrient content claims as claims in the label or labeling of a food
that ``expressly or by implication'' ``characterize the level of any
nutrient in a food'' (section 403(r)(1)(A) of the FD&C Act). The claim
``healthy'' on its face is an implied claim because it suggests that
the food, because of its nutrient content, may help consumers maintain
healthy dietary practices. In the 1994 definition of the claim, levels
for nine different individual nutrients were discussed: fat, saturated
fat, cholesterol, vitamin A, vitamin C, calcium, iron, protein, and
fiber (21 CFR 101.65(d)(2)(i)). As discussed elsewhere in this
document, in recent years the Dietary Guidelines have shifted to
recommending healthy dietary patterns and the consumption of food
groups in certain quantities to achieve adequate nutrient intake, based
on the understanding that each food group contributes an array of
important nutrients to the diet (Dietary Guidelines, 2020-2025).
Specifically, the Dietary Guidelines, 2020-2025 states that because
foods provide an array of nutrients and other components that have
health benefits, nutritional needs should be met primarily through a
variety of nutrient-dense foods. Additionally, the Dietary Guidelines,
2020-2025 recommends increasing intakes of food groups to move intakes
of underconsumed dietary components closer to recommendations.
    Accordingly, the new proposed definition includes food groups that
provide a number of different nutrients and is thus characterizing the
overall nutrient content of the food, rather than focusing on one
individual nutrient in isolation, as with an express nutrient content
claim. Each food group that is included in the food group requirement
for the proposed updated definition of the ``healthy'' claim represents
the inclusion of multiple important nutrients. Therefore, the use of
food groups better accounts for how all these nutrients contribute to,
and may work synergistically to create, a healthy dietary pattern and
improve health outcomes. By requiring products to contain a certain
amount of a food group, the proposed rule will help ensure foods
bearing the ``healthy'' claim contain a variety of important beneficial
nutrients and, therefore, help Americans meet recommended nutrient
intakes and maintain healthy dietary patterns. Consistent with
Congress's objectives to provide appropriate nutritional information to
consumers, and based on current nutrition science and Federal dietary
guidance, the statutory phrase ``characterize the level of any nutrient
in a food'' encompasses both limits on certain individual nutrients and
food group criteria that more broadly incorporate a variety of
nutrients from nutrient dense foods which may also have a synergistic
effect.
    In addition to section 403(r)(2) of the FD&C Act, we are issuing
this proposed rule under section 701(a) of the FD&C Act, which states
that we may issue regulations for the efficient enforcement of the FD&C
Act and has been interpreted to apply in order to ``effectuate a
congressional objective expressed elsewhere in the Act'' (Association
of American Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204
(D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v. FDA, 484 F. Sup. 1179,
1183 (D. Del. 1980)).
    We are also relying on our authority under sections 403(r), 403(a),
201(n) and 701(a) of the FD&C Act, to propose records requirements
designed to ensure that the use of the ``healthy'' claim is accurate,
truthful and not misleading, based on information known only to the
manufacturer, and to facilitate efficient and effective action to
enforce the requirements when necessary. Our authority to establish
records requirements has been upheld under other provisions of the FD&C
Act where FDA has found such records to be necessary (National
Confectioners Assoc. v. Califano, 569 F.2d 690, 693-94 (D.C. Cir.
1978)). The recordkeeping we propose to require applies only to foods
voluntarily bearing the ``healthy'' claim for which an adequate
analytical method to determine food group equivalents is not available
or the amount cannot be discerned from the label alone. The records
would allow us to verify that the product meets the requirements to
bear the claim and that use of the nutrient content claim ``healthy''
is truthful and not misleading. Thus, the proposed records requirements
would help in the efficient enforcement of the FD&C Act (see discussion
in section VI.B.4 ``Records Requirements'' for more information).
    The authority granted to FDA under sections 701(a), 403(r),
403(a)(1) and 201(n) of the FD&C Act not only includes authority to
establish records requirements, but also includes access to such
records. Without access to such records, FDA would not know whether the
food meets the proposed requirements to bear the ``healthy'' claim
consistent with section 403(r) of the FD&C Act, and whether the use of
the claim is truthful and not misleading under sections 403(a)(1) and
201(n) of the FD&C Act. The introduction or delivery for introduction
into interstate commerce of a misbranded food is a prohibited act under
section 301(a) of the FD&C Act (21 U.S.C. 331(a)). Thus, to determine
whether a food that is voluntarily bearing a ``healthy'' nutrient
content claim is misbranded and the manufacturer has committed a
prohibited act, we must have access to the manufacturer's records that
we are requiring be kept under proposed Sec.  101.65(d)(4) (21 CFR
101.65(d)(4)). Failure to make and keep records and provide the records
to FDA, as described in proposed Sec.  101.65(d)(4), would result in
the food bearing the ``healthy'' claim being misbranded under sections
403(r) and 403(a)(1) of the FD&C Act.

VI. Proposed Action

    We propose to update the ``healthy'' nutrient content claim to
align its criteria with our updates to the Nutrition Facts label and
with current nutrition science and Federal dietary guidance, especially
the Dietary Guidelines, 2020-2025. We also took several additional
factors into

consideration while developing the proposed, updated criteria for
``healthy.'' We intend for the updated ``healthy'' criteria to help
identify and encourage consumption of nutrient-dense foods to meet
current nutrition science and Federal dietary guidance, especially the
intake recommendations of the individual food groups as discussed in
the Dietary Guidelines, 2020-2025. We also intend for the ``healthy''
criteria to be appropriately flexible to allow for industry innovation,
thereby increasing the availability of foods in the marketplace that
will help consumers meet dietary recommendations. Finally, we based the
proposed criteria on well-established and longstanding foundations of
dietary guidance, including food group recommendations and nutrients to
limit.

A. Overview of Approach

    The Dietary Guidelines, 2020-2025 recommends following a healthy
dietary pattern at every life stage with a focus on meeting food group
needs with nutrient-dense foods and beverages, and staying within
calorie limits. Specifically, the Dietary Guidelines, 2020-2025 states
that because foods provide an array of nutrients and other components
that have health benefits, nutritional needs should be met primarily
through a variety of nutrient dense foods. Additionally, the Dietary
Guidelines, 2020-2025 recommends increasing intakes of food groups to
move intakes of underconsumed dietary components closer to
recommendations. Consistent with current nutrition science and Federal
dietary guidance, our proposed, updated criteria for ``healthy'' use an
approach based on both food groups and nutrients to limit, rather than
focusing solely on individual nutrients. The updated ``healthy''
criteria emphasize the food groups and subgroups identified in the
Dietary Guidelines, 2020-2025 as part of a healthy dietary pattern:
vegetables, fruits, grains, dairy, and protein foods, as well as oils.
Under the proposed, updated criteria, food products would need to
contain a certain amount of food (a ``food group equivalent'') from at
least one of these recommended food groups or subgroups (e.g., \1/2\
cup of fruit or \3/4\ cup of dairy) to be labeled ``healthy.'' The
proposed incorporation of food group criteria is consistent with the
current nutrition science articulated in the Dietary Guidelines, 2020-
2025 and its focus on dietary patterns as a whole and is appropriate
for this implied nutrient content claim because claims that imply a
food product contains a certain amount of a food group would
characterize the level of a variety of nutrients important to help
consumers maintain healthy dietary practices.
    In addition to the food group criteria, we are proposing that foods
must continue to adhere to certain criteria regarding nutrients to
limit to be labeled ``healthy.'' Specifically, we propose maintaining
sodium and saturated fat as nutrients to limit (which are already
included in the current criteria), along with adding a limit on added
sugars, consistent with the rationale for the new Nutrition Facts label
requirement for added sugars declaration. These criteria are also
consistent with the Dietary Guidelines, 2020-2025 recommendations to
limit intake of sodium, saturated fat, and added sugars, and, based on
current nutrition science, would strengthen the public health benefits
of foods bearing the ``healthy'' claim. The specific food group
criteria and the nutrients to limit are discussed in further detail in
sections VI.A.1 and VI.A.2 (``Food Groups'' and ``Nutrients to
Limit'').
    Because of the proposed food group approach, we propose that the
``healthy'' criteria no longer include minimum amounts of nutrients to
encourage (i.e., nutrients that are underconsumed and whose low intake
in the general population or in individual subpopulations raise public
health concern). The Dietary Guidelines, 2020-2025 recommendations to
consume various food groups and subgroups in certain quantities are
intended to ensure overall nutritional adequacy and consumption in a
manner to help consumers maintain healthy dietary practices. FDA is
concerned that including criteria for nutrients to encourage could spur
fortification to allow foods that are low in saturated fat, sodium, and
added sugars to qualify for the ``healthy'' claim, despite these foods
not contributing to a meaningful amount of a food group (e.g., white
bread fortified with calcium). FDA does not support indiscriminate
fortification of foods but, rather, encourages the rational addition of
nutrients to foods, as discussed further in our fortification policy
guidance (Ref. 30). We request comment on whether nutrients to
encourage should be included in addition to the food group criteria.
    As described below, there are some foods that we propose to include
in the updated criteria for ``healthy'' including raw, whole fruits and
vegetables, and water, that under the proposed updated criteria, will
not need to meet requirements for food group equivalents and nutrients
to limit. These foods are included in categories of food that can
automatically use the ``healthy'' claim because of their nutrient
content and positive contribution to an overall healthy diet. This is
not the case for these foods under the current rule; rather the
individual fruit or vegetable must meet the criteria for the nutrients
to limit (total fat, saturated fat, sodium, cholesterol) in order to
bear the ``healthy'' claim. These exceptions will be discussed in
further detail in section VI.B.3 (``Covered Products'').
1. Food Groups
    Current nutrition science and Federal dietary guidance specifically
emphasize the importance of following a healthy dietary pattern across
the lifespan (Ref. 1). As described earlier, the Dietary Guidelines,
2020-2025 notes that foods and beverages are not consumed in isolation,
but rather in various combinations over time--a ``dietary pattern.''
Components of a dietary pattern may have interactive, synergistic, and
potentially cumulative relationships, such that the dietary pattern may
be more predictive of overall health status and disease risk than
individual foods or nutrients (Ref. 1). The principal message of the
Dietary Guidelines, 2020-2025 is to follow a healthy dietary pattern
that focuses on meeting food group needs with nutrient-dense foods and
beverages and stays within calorie limits. The recommendations include
an emphasis on meeting nutritional needs ``primarily from foods and
beverages--specifically, nutrient-dense foods and beverages'' (Ref. 1),
as opposed to dietary supplements. While FDA's definition includes
dietary supplements as foods, they may not always be included in what
the nutrition science literature refers to as ``foods.'' This
recommendation also reflects the view that good nutrition does not come
from intake of individual nutrients (as dietary supplements often
provide) but rather from foods with their mix of various nutrients
working together in combination. The Dietary Guidelines, 2020-2025 goes
on to describe that ``[e]ating an appropriate mix of foods from the
food groups and subgroups--within an appropriate calorie level--is
important to promote health at each life stage. Each of the food groups
and their subgroups provides an array of nutrients, and the amounts
recommended reflect eating patterns that have been associated with
positive health outcomes'' (Ref. 1, page 31). This focus on food groups
is consistent with longstanding Federal nutrition education and
messaging structured around food groups, such as those associated with
MyPlate and the former MyPyramid Food Guidance System and Food Guide
Pyramid (Ref. 14).

    The Dietary Guidelines, 2020-2025 further explains that a healthy
dietary pattern includes:
     Vegetables of all types--dark green; red and orange;
beans, peas, and lentils; starchy; and other vegetables;
     Fruits, especially whole fruit;
     Grains, at least half of which are whole grain;
     Dairy, including fat-free or low-fat milk, yogurt, and
cheese, and/or lactose-free versions and fortified soy beverages and
soy yogurt alternatives;
     Protein foods, including lean meats, poultry, and eggs;
seafood; beans, peas, and lentils; and nuts, seeds, and soy products;
     Oils, including vegetable oils and oils in food, such as
seafood and nuts.
    In the Dietary Guidelines, 2020-2025 and previous iterations, foods
fit into groups based on how they are consumed, and their nutrient
content, even if this is different from their botanical classification.
For example, a bell pepper is considered a vegetable in the Dietary
Guidelines, 2020-2025 even though it is botanically a fruit.
Additionally, foods from the same source may be categorized differently
depending on how they are consumed. For example, soybean oil is
classified as an oil, but tofu made from soybeans is classified as a
protein food in the Dietary Guidelines, 2020-2025. In considering which
foods contribute to meeting the individual food group requirements, we
are adopting the categorizations used in the Dietary Guidelines, 2020-
2025 to determine the appropriate food group for the food. For example,
in the previously mentioned bell pepper example, the presence of bell
pepper ingredients would contribute to satisfying the vegetable food
group requirements, rather than the requirements for fruit ingredients.
    Evidence relied on in the Dietary Guidelines, 2020-2025 shows that
a healthy dietary pattern, as outlined above, is associated with
beneficial outcomes for all-cause mortality, cardiovascular disease,
overweight and obesity, type 2 diabetes, bone health, and certain types
of cancer) (Ref. 1). Specifically, evidence shows that common
characteristics of dietary patterns associated with positive health
outcomes include relatively higher intake of vegetables, fruits,
legumes, whole grains, low- or non-fat dairy, lean meats and poultry,
seafood, nuts, and unsaturated vegetable oils, and relatively lower
consumption of red and processed meats, sugar-sweetened foods and
beverages, and refined grains (Ref. 1).
    The existing criteria for ``healthy'' at Sec.  101.65(d)(2) include
minimum content thresholds for a limited number of nutrients for which
consumption is encouraged. These nutrient criteria were originally
included to identify foods that are particularly helpful to consumers
in maintaining healthy dietary practices and achieving dietary
recommendations. Instead of including a limited set of nutrients for
which consumption is encouraged in the definition as surrogates for
recommended food groups and subgroups, we propose to directly
incorporate food groups as criteria in the definition of the claim
``healthy.'' We tentatively conclude that using food groups to
encourage as the criteria for ``healthy,'' rather than a limited set of
nutrients, would better identify foods with the nutrient content that
may help consumers maintain healthy dietary practices, consistent with
current nutrition science and Federal dietary guidance. This approach
is consistent with the Dietary Guidelines, 2020-2025 focus on overall
dietary patterns to ensure that a range of nutrients are consumed at
appropriate levels, rather than on nutrients in isolation. We solicit
comment on this tentative conclusion.
    Our proposed criteria for updating ``healthy'' emphasize healthy
dietary patterns by requiring that food products contain a certain
amount of food from a recommended food group to bear the claim
``healthy.'' In this rule, the phrase ``food group'' refers to the
groups of foods recommended in the Dietary Guidelines, 2020-2025, which
include vegetables, fruits, dairy, grains, protein foods, as well as
oils (Ref. 1). The Dietary Guidelines, 2020-2025 does not categorize
oils as a ``food group,'' but they emphasize that oils are one of the
six core elements of a healthy dietary pattern, along with vegetables,
fruits, grains, dairy, and protein foods, and recommend daily intake
objectives for oils, similar to the food groups. Therefore, we will
include oils as a food group for purposes of this rule. However,
because of their specific role in healthy dietary patterns, the
proposed criteria for oils differ from the criteria for other food
groups, as discussed in further detail in section VI.B.3 (``Covered
Products''). In this rule, the phrase ``food group equivalent'' refers
to the amount of a food group that must be contained in a food product
for it to bear the ``healthy'' claim. In this rule, the phrase ``food
group equivalent'' refers to the amount of a food group that must be
contained in a food product for it to bear the ``healthy'' claim.
    We used the ``Healthy U.S.-Style Dietary Pattern,'' as described in
table A3-2 in the Dietary Guidelines, 2020-2025 (Ref. 1), using the
2000-calorie level pattern as the reference, to determine the food
group equivalent amounts. We are basing our food group equivalent
recommendations on amounts recommended at the 2,000 calorie level
because 2,000 calories is often used for general nutrition advice and
this reference amount is already used for other purposes in nutrition
labeling. The 2000-calorie level pattern establishes specific daily
food group and subgroup amounts in cup-equivalents (c-eq), ounce-
equivalents (oz-eq), or grams (g), depending on the type of food. Cup-
and ounce-equivalents identify the amounts of foods from each food
group with similar nutritional content. For example, while the
structural forms of whole wheat bread and brown rice are very
different, the Dietary Guidelines, 2020-2025 considers one medium (1
oz) slice of whole wheat bread to be nutritionally similar to one half
cup of cooked brown rice, and both represent an oz-eq of whole grains.
The 2000-calorie level dietary pattern establishes daily amounts for
each food group as follows:
     2\1/2\ c-eq of vegetables (comprising recommendations for
vegetable subgroups);
     2 c-eq of fruits;
     6 oz-eq of grains, of which at least 3 oz-eq should be
whole grains;
     3 c-eq of dairy;
     5\1/2\ oz-eq of protein foods (comprising recommendations
for protein food subgroups, such as seafood); and
     27 g of oils.
    In past rulemakings, we have assumed that the typical American
dietary pattern is three meals and one snack per day, i.e., four eating
occasions, not including beverage-only eating occasions (see final
rules on general requirements for health claims and nutrient content
claims in food labeling, 58 FR 2478 at 2495 and 58 FR 2302 at 2379 to
2380). In other words, we assume that individuals generally have four
opportunities in a day to meet the recommended daily food group amounts
in the Healthy U.S.-Style Dietary Pattern, and thereby satisfy their
nutritional needs. Consistent with this assumption, and with our
approach in past rulemakings, our proposed food group equivalents are
based on four eating occasions per day. To determine the amount of a
food group required for an individual food to bear the ``healthy''
claim, we divided the recommended daily food group amounts by four
eating occasions. For example, because the recommended daily amount of
fruit in the 2000-calorie level pattern is 2 c-eq, we determined that
the food group equivalent for fruit would be \1/2\ c-eq

(i.e., 2 c-eq divided by four). This would mean that a ``fruit
product'' would need to contain \1/2\ c-eq of fruit per RACC (in
addition to other requirements) to meet the proposed criteria for
``healthy.'' While this calculation provided a baseline amount for the
food group equivalent requirements, we adjusted the baseline amount for
certain food groups and subgroups, as warranted, based on
considerations as described in section VI.B.3 (``Covered Products'').
This calculation also informs the food group criteria for combination
foods (foods that contain a meaningful amount of more than one food
group) as will be discussed in section VI.B.3 (``Covered Products'').
We seek comment on this proposed calculation--based on four eating
occasions per day--for the food group equivalent requirement.
2. Nutrients to Limit
    While our proposed updates to the ``healthy'' regulation reflect
the importance of the overall nutrient content of foods that build
dietary patterns rather than individual nutrients in isolation, we do
propose keeping certain nutrients to limit as criteria for bearing the
claim ``healthy.'' This is because current nutrition science and
Federal dietary guidance continue to recommend limiting certain
nutrients as a key component in emphasizing healthy overall dietary
patterns. In the NFL Final Rule, we found that nutrition science
supports limiting intake of saturated fat, sodium, and added sugars.
Similarly, the Dietary Guidelines, 2020-2025 includes recommendations
to choose nutrient-dense foods across and within food groups while
limiting foods and beverages higher in added sugars, saturated fat, and
sodium (Ref. 1). Moreover, under the Dietary Guidelines, 2020-2025,
``nutrient dense'' food and beverages are defined as foods and
beverages that provide vitamins, minerals, and other health-promoting
components and have little added sugars, saturated fat, and sodium.
Vegetables, fruits, whole grains, seafood, eggs, beans, peas, and
lentils, unsalted nuts and seeds, fat-free and low-fat dairy products-,
and lean meats and poultry--when prepared with no or little added
sugars, saturated fat, and sodium--are identified as nutrient-dense
foods (Ref. 1). Thus, in addition to the food group criteria for
``healthy,'' we are proposing updates to criteria for nutrients to
limit for saturated fat, sodium, and are proposing to add criteria for
added sugars. The proposed nutrients to limit criteria help ensure that
foods bearing the ``healthy'' claim do not contain excess saturated
fat, sodium, or added sugars, which can increase calories and/or the
risk of chronic disease and therefore diminish the potential beneficial
public health impact of the ``healthy'' claim.
    In setting the criteria for nutrients to limit, we are proposing
baseline values for each nutrient and have adjusted the values, as
warranted. Different food groups and subgroups each contain foods that
provide a variety of nutrients, including important nutrients that are
underconsumed and some naturally contain higher amounts of nutrients
that should be limited. For example, dairy foods provide vitamin D and
calcium; however, they also may contain saturated fat. In contrast,
fruits and vegetables contain minimal or no saturated fat. Using the
same saturated fat criteria across all food groups could exclude foods
that provide important nutrients and that are recommended by the
Dietary Guidelines, such as low-fat milk and low-fat cheese. However,
increasing the saturated fat limit across all food groups could
encourage the unnecessary addition of saturated fat for foods in food
groups such as vegetables, which are generally not sources of saturated
fat. Therefore, based on current nutrition science and Federal dietary
guidance, adjustments to the baseline amount for different food groups
allow a variety of foods across recommended food groups to meet the
proposed, updated definition without encouraging unnecessary addition
of saturated fat, sodium, and added sugars. The adjustments made to the
baseline amount for different food groups and subgroups are further
described in section VI.B.3.b (``Individual foods'').
    The baseline values are percentages of the DV for each nutrient to
help ensure flexibility and longevity of the ``healthy'' criteria if
the DVs shift in the future. DVs are reference amounts of nutrients to
consume or not to exceed each day. Historically, the DVs established in
regulation by FDA have been based on the nutritional needs of adults
and children 4 years of age and older. However, the recent revisions to
the regulations for the Nutrition Facts label have established DVs
specific to infants up to 12 months of age and to children 1 to 3 years
of age (Sec.  101.9(c)(9)). As discussed earlier, we are proposing that
use of the nutrient content claim ``healthy'' remains limited to adults
and children 2 years of age and older. Therefore, the claim ``healthy''
could appear on foods directed to children 2 to 3 years of age and on
foods directed to adults and children 4 years of age and older. When
determining eligibility for use of the claim ``healthy,'' specifically
whether a food meets the ``percent DV'' criteria for saturated fat,
sodium, and added sugars, the ``percent DV'' criteria will be based on
the set of DVs appropriate for that food. For the majority of foods,
the DVs established for adults and children 4 years of age and older
will be the basis of the nutrient criteria for the claim that are
discussed in the following sections. However, for the subset of foods
specifically directed to children 2 to 3 years of age (e.g., fruit
pouches, toddler snack puffs), the basis of the ``percent DV'' nutrient
criteria are the specific set of DVs established for that age range in
Sec.  101.9(c)(9).
a. Saturated Fat
    The current ``healthy'' nutrient content claim regulation includes
limits on saturated fat for all food categories (Sec.
101.65(d)(2)(i)(A)-(F)). Dietary recommendations have long recognized
the well-established relationship between consumption of saturated fat
and its effect on blood cholesterol levels (Refs. 16 and 17). Evidence
shows that replacement of saturated fats with unsaturated fats,
especially polyunsaturated fats, reduces blood total cholesterol and
low-density lipoprotein cholesterol (LDL-cholesterol) concentrations
and, therefore, the risk of CVD (Ref. 16). Evidence shows that
replacing saturated fats with polyunsaturated fats is associated with a
reduced risk of CVD mortality and/or coronary heart disease (CHD) (Ref.
16). Saturated fat is required to be declared on food labels by section
403(q)(1)(D) of the FD&C Act, and we reaffirmed in the NFL Final Rule
that saturated fat declaration is necessary to assist consumers in
maintaining healthy dietary practices (81 FR 33742 at 33786).
    The DVs for nutrients are established either as RDIs or as DRVs.
The DRV for saturated fat is 20 grams (for children 1 to 3 years old,
the DRV is 10 grams), which is approximately 10 percent of calories
based on a 2,000-calorie reference intake level (Sec.  101.9(c)(9)). In
the preamble to the proposed NFL rule (79 FR 11879 at 11895, March 3,
2014, Docket No. FDA-2012-N-1210), we discussed how consensus reports
(e.g., Institute of Medicine (IOM) Dietary Reference Intakes (DRI) and
2002 report from the National Cholesterol Education Program of the
National Institutes of Health's National Heart, Lung, and Blood
Institute) continue to recommend saturated fat intakes of no more than
10 percent of calories, based on risk of CVD. We reaffirmed in the NFL
Final Rule that the 20-gram DRV is consistent with scientific evidence
(81 FR 33742 at 33786). Additionally, the Dietary Guidelines have
consistently

recommended limiting calories from saturated fats. The Dietary
Guidelines, 2020-2025 states that intake of saturated fat should be
limited to less than 10 percent of calories per day by replacing them
with unsaturated fats, particularly polyunsaturated fats. Accordingly,
we propose limiting saturated fat in foods bearing the implied nutrient
content claim ``healthy,'' to ensure that such foods do not contribute
to a dietary pattern that contains excess saturated fat. Many of the
comments on the RFI supported including a limit on saturated fat in
foods bearing the ``healthy'' claim.
    For saturated fat, we are proposing a baseline limit of 5 percent
of the DV per RACC (<=1 g for adults and children 4 years of age and
older). This level is consistent with the low saturated fat nutrient
content claim (21 CFR 101.62(c)(2)), and with the saturated fat
criteria for most of the individual foods in the current definition for
``healthy.'' We are also proposing to adjust the baseline limit for
saturated fat, as warranted, based on specific nutrient considerations
associated with the different food groups and subgroups and the Dietary
Guideline consumption recommendations for different food groups. As
discussed in section V.B.3.b (``Individual foods''), we are proposing
the baseline limit for saturated fat (5 percent of the DV per RACC) for
fruit products; vegetable products; grain products; bean, pea, and soy
products; and nut and seed products (excluding saturated fat derived
from nuts and seeds, as discussed in section VI.B.3.b (``Individual
foods''). We are proposing the following adjustments to the baseline
limit for saturated fat, as described further in the discussion of
individual foods below, for certain categories of foods that are core
elements of healthful dietary patterns associated with reducing chronic
disease risk (e.g., low-fat dairy products): 10 percent of the DV for
dairy products; 10 percent of the DV for game meats, seafood, and eggs;
and 20 percent of total fat for oils and oil-based spreads and
dressings.
    We are also considering alternatives to the proposed limits on
saturated fat. We are considering an approach using a ratio of
saturated fat to total fat, such as a ratio based on current DVs for
saturated fat and total fat, which are based on 10 percent and 35
percent of daily calorie intake, respectively. The intent of this
approach would be to apply a single ratio across all food groups,
thereby reducing the variation in the currently proposed limits, while
still allowing some flexibility for foods that provide monounsaturated
and polyunsaturated fats. We seek comment on the use of a limit for
saturated fat based on the ratio of saturated fat to total fat,
including any data supporting this approach.
b. Sodium
    The current ``healthy'' nutrient content regulation includes limits
on sodium content for all food categories (Sec.  101.65(d)(2)(ii)).
Dietary recommendations have long emphasized reductions in sodium
intake because average population-level intake continually exceeds
recommended levels. As we stated in the NFL Final Rule, evidence
continues to support the association between increased sodium
consumption and blood pressure (81 FR 33742 at 33875). For example, the
National Academy of Medicine (formerly IOM), of the National Academies
of Sciences, Engineering, and Medicine (National Academies), 2005 DRI
Electrolytes Report noted a direct relationship between sodium intake
and increased blood pressure (Ref. 9) and the 2013 National Academies
report entitled ``Sodium Intake in Populations: Assessment of the
Evidence'' (Ref. 8) concluded that a strong body of evidence has been
documented in adults that blood pressure decreases as sodium intake
decreases. The Scientific Report of the 2020 Dietary Guidelines
Advisory Committee Report (2020 DGAC Report) states that sodium intake
is directly related to blood pressure across the lifespan and that
elevated blood pressure contributes to the risk of CVD and stroke,
which are both leading causes of morbidity and mortality in the United
States (Ref. 15).
    Reducing sodium intake has also been a consistent recommendation in
the Dietary Guidelines; the Dietary Guidelines, 2020-2025 carries
forward the National Academies' recommendation to limit sodium to less
than 2,300 milligrams (mg) per day--and even less for children younger
than age 14 (Refs. 1 and 17). According to the Dietary Guidelines,
2020-2025, healthy dietary patterns limit sodium to the Chronic Disease
Risk Reduction (CDRR) levels defined by the National Academies--1,200
mg/day for ages 1 through 3; 1,500 mg/day for ages 4 through 8; 1,800
mg/day for ages 9 through 13; and 2,300 mg/day for all other age
groups. However, average intakes of sodium are high across the U.S.
population compared to the CDRR levels. Average intakes for those ages
1 and older is 3,393 mg/day, with a range of about 2,000 to 5,000 mg/
day (Ref. 1). In 2019, the National Academies set the CDRR levels for
sodium based on evidence of the beneficial effect of reducing sodium
intake on blood pressure and risk of CVD and hypertension (Ref. 17).
This most recent evaluation of the evidence reaffirms the 2,300 mg/day
recommended daily limit for those 14 years and older. To reduce sodium
intake to the recommended limits, the Dietary Guidelines, 2020-2025
recommends implementing multiple strategies, including making food
choices in all food groups with less sodium (Ref. 1). We propose to
include a limit on the amount of sodium in foods bearing the nutrient
content claim ``healthy'' to help individuals identify foods that are
consistent with dietary recommendations for sodium. Many comments on
the RFI supported a sodium limit on foods bearing the claim
``healthy.''
    The DRV for sodium is 2,300 mg (for children 1 to 3 years old, the
DRV is 1,500 mg). We are proposing a baseline sodium limit of <=10
percent of the DV (currently, 230 mg for adults and children 4 years of
age and older) per RACC for individual foods. This proposed, updated
sodium limit is lower than the limit in the existing criteria for
``healthy'' (480 mg, or about 20 percent of current DV) (Sec.
101.65(d)(2)(ii)). We expect that it is feasible to lower the sodium
level requirement for ``healthy'' due to reductions in sodium in
certain foods and food categories in response to consumer support for
policies to limit sodium content in manufactured foods (Refs. 18 and
19) and to technological progress since the existing definition of
``healthy'' was issued in 1994. Additionally, in October 2021, FDA
published short-term (2.5 year) voluntary sodium reduction targets for
the food industry (Ref. 31). These targets are anticipated to support
gradual sodium reduction in the food supply and increase available
options that are lower in sodium. When selecting the proposed, updated
limit for the ``healthy'' claim, we considered the many functions of
sodium in food, including taste, texture, microbial safety, and
stability. For example, while a baseline limit for sodium of <=5
percent of the DV would be consistent with the proposed saturated fat
and added sugar baseline limits and the low sodium nutrient content
claim, we are concerned that a limit of <=5 percent of the DV for
sodium is not practical at this time. We are proposing to adjust the
baseline values for sodium as warranted, based on specific
considerations of the different food groups and subgroups, as described
below. We seek comment on this approach.

c. Added Sugars
    In the NFL Final Rule, we required the declaration of the amount of
added sugars in a serving of a product after we concluded that evidence
on dietary patterns and health outcomes supports a mandatory
declaration of added sugars (81 FR 33742 at 33799). We determined that
declaration of the amount and percent DV of added sugars in a serving
of a product is necessary to assist consumers to maintain healthy
dietary practices and determine how a serving of a product fits into
the context of their total daily diet (81 FR 33742 at 33804). This
conclusion was based on scientific evidence showing that healthy
dietary patterns characterized, in part, by lower intakes of sugar-
sweetened foods and beverages are associated with a decreased risk of
CVD (Ref. 7). This is consistent with a key recommendation of the
Dietary Guidelines, 2020-2025 to limit foods and beverages higher in
added sugars (Ref. 1). To achieve this recommendation, the Dietary
Guidelines, 2020-2025 recommends that individuals 2 years of age and
older consume less than 10 percent of calories per day from added
sugars.
    Current consumption data indicate that most Americans are consuming
more than 10 percent of calories from added sugars (Ref. 16). According
to the 2020 DGAC Report, current intake of added sugars remains high at
267 calories, or 12.7 percent of total calories per day among the total
population ages 1 year old and older (Ref. 16). Evidence shows that
consumption of excess calories from added sugars can lead to a less
nutrient-dense diet. When sugars are added to foods and beverages, the
sugars add calories without contributing essential nutrients. Foods
with added sugars displace other nutrient-dense foods in the diet, and
as the amount of added sugars increase in the diet, it becomes more
difficult to also eat foods with sufficient dietary fiber and essential
vitamins and minerals and stay within calorie limits. Thus, a diet low
in added sugars helps individuals achieve a healthy dietary pattern
through nutrient-dense choices within calorie limits (Ref. 1). Many of
the comments on the RFI and public meeting support limiting the amount
of added sugars permitted in foods bearing the claim ``healthy.''
    Consistent with our rationale in the NFL Final Rule and with the
Dietary Guidelines, 2020-2025, we find that it is critical that foods
bearing the implied nutrient content claim ``healthy'' do not
contribute to a dietary pattern that contains added sugars over the
recommended levels. We therefore propose including a limit on the
amount of added sugars in foods bearing the nutrient content claim
``healthy'' to help consumers choose foods that will contribute to a
healthy dietary pattern that is lower in added sugars, consistent with
current nutrition science and Federal dietary guidance. The DRV for
added sugars is 50 g (for children 1 to 3 years old, the DRV is 13 g).
For individual foods, we are proposing a baseline value for added
sugars of <=5 percent of the DV per RACC (<=2\1/2\ g for adults and
children 4 years of age and older). While there is no low added sugars
nutrient content claim, the proposed <=5 percent DV level is consistent
with our approach of using a low in saturated fat claim, which the
Dietary Guidelines, 2020-2025 also recommends limiting to less than 10
percent of calories per day starting at age 2. We are also proposing to
adjust the baseline values for added sugars as warranted, based on
specific considerations of the different food groups and subgroups, as
described in the discussion of individual food groups below. We seek
comment on this approach.
    We note that high-intensity (low- and no-calorie) sweeteners are
not considered added sugars by FDA. Additionally, the Dietary
Guidelines, 2020-2025 does not consider high-intensity sweeteners to be
added sugars and do not make any recommendations for those 2 years of
age and older on the intake of high-intensity sweeteners. Therefore,
high-intensity sweeteners are not a factor in this proposed rule. The
Dietary Guidelines, 2020-2025 did note that ``replacing added sugars
with low- and no-calorie sweeteners may reduce calorie intake in the
short-term and aid in weight management, yet questions remain about
their effectiveness as a long-term weight management strategy.'' FDA
reviews high-intensity sweeteners for use in foods based on available
scientific evidence. There is reasonable certainty of no harm under the
intended conditions of use of high-intensity sweeteners because the
estimated daily intake is not expected to exceed the acceptable daily
intake for each sweetener.
d. Nutrients Not Included
(1) Total Fat
    In contrast to the existing criteria at Sec.  101.65(d), we propose
removing the limit for total fat in the updated criteria for
``healthy.'' Federal dietary guidance, based on current nutrition
science, has shifted away from recommending diets low in total fat--
which includes saturated fat, trans fat, and unsaturated fat--to focus
instead on the types of fat in the diet due to their different effects
on health outcomes. The Dietary Guidelines, 2020-2025, for example,
includes no key recommendation for intake of total fat, and emphasize
replacing intake of saturated fats with unsaturated fats, particularly
polyunsaturated fats (Ref. 1). The shift away from emphasizing total
fat is also reflected in the NFL Final Rule (81 FR 33742). For example,
the declaration of ``Calories from fat'' is no longer required on the
Nutrition Facts label because current nutrition science supports a view
that the type of fat is more relevant than overall total fat intake in
risk of chronic diseases. Reflecting this shift in science, our
guidance for industry on the use of the term ``healthy,'' published in
2016, advises food manufacturers of our intent to exercise enforcement
discretion for products labeled ``healthy'' that are not low in total
fat, but have a fat profile makeup of predominantly monounsaturated and
polyunsaturated fat (Ref. 19). Therefore, while we propose maintaining
a limit on saturated fat, we are not proposing to include total fat as
part of the criteria for the ``healthy'' nutrient content claim.
(2) Trans Fat
    In 2015, we released a final determination that partially
hydrogenated oils (PHOs) which are the primary dietary source of
industrially produced trans fat, are no longer generally recognized as
safe for use in food (80 FR 34650, June 17, 2015) to eliminate the
majority of uses of PHOs. The compliance date for this determination
was June 18, 2018, for most foods, with extended compliance dates in
2020 and 2021 for certain uses of PHOs (83 FR 23358, May 21, 2018). As
a result of this determination, what was previously the primary dietary
source of trans fat has been largely removed from the food supply.
    We recognize that there are other sources of trans fat in the food
supply, including refined edible oils and naturally occurring sources
in products from ruminant animals (e.g., meat and dairy). The Dietary
Guidelines, 2020-2025 does not make any recommendations regarding
intake of trans fat but notes that the National Academies recommends
that trans fat consumption be as low as possible without compromising
the nutritional adequacy of the diet. However, because foods that
contain declarable levels of trans fat from sources other than PHOs
typically contain saturated fat as well, we expect that the proposed
saturated fat limits will disqualify most foods containing declarable
levels of naturally

occurring trans fat from meeting the ``healthy'' criteria (Ref. 20).
Therefore, we are not proposing to include a limit for trans fat in the
updated ``healthy'' criteria because we do not think such a limit is
necessary due to the limits we are proposing for saturated fat in this
rule and due to our other regulatory actions to remove PHOs from the
marketplace. We seek comment on our proposed approach to trans fat,
including any data demonstrating that the saturated fat limit will not
adequately disqualify foods containing trans fat from meeting the
proposed ``healthy'' definition.
(3) Dietary Cholesterol
    The Dietary Guidelines, 2020-2025 does not make any recommendations
regarding intake of dietary cholesterol but discuss dietary cholesterol
in conjunction with trans fat and note that the National Academies
recommends that dietary cholesterol consumption be as low as possible
without compromising the nutritional adequacy of the diet. The Dietary
Guidelines, 2020-2025 also notes that the USDA Dietary Patterns are
limited in dietary cholesterol (Ref. 1). Additionally, the 2020 DGAC
Report states that ``[b]ecause dietary cholesterol is found only in
animal-source foods that are typically also sources of saturated fat,
the independent effects on blood lipids and CVD are difficult to
assess. Although, we recognize the importance of limiting dietary
cholesterol, we tentatively conclude that it is unnecessary to include
a limit for dietary cholesterol for the ``healthy'' claim because, as
with trans fat, dietary cholesterol is already sufficiently limited by
the proposed limits for saturated fat.
    Dietary cholesterol and saturated fats are found in similar foods,
i.e., foods that are higher in dietary cholesterol, such as fatty meats
and full-fat cheese, which are generally also higher in saturated fats
(Ref. 16). As a result, a dietary pattern low in saturated fat is
typically also low in dietary cholesterol. We therefore expect that the
proposed saturated fat value of 5 percent DV per RACC (or the adjusted
baseline limit for certain foods) will disqualify most foods that
contain more than 60 mg of dietary cholesterol, the current limit under
Sec.  101.65, from meeting the proposed ``healthy'' criteria.
    There are a few exceptions, including foods such as eggs and some
shellfish, that contain <=5 percent DV of saturated fat per RACC and
are not low in dietary cholesterol (Ref. 20). However, eggs and seafood
(which includes fish and shellfish) are specifically highlighted in the
Dietary Guidelines, 2020-2025 as being nutrient-dense foods, supplying
nutrients such as choline, vitamin D, and essential fatty acids (Refs.
1 and 17). The Dietary Guidelines, 2020-2025 also found that almost 90
percent of Americans do not meet the recommendations for consumption of
seafood, and specifically recommend shifts within the protein foods
group to increase seafood intake.
    Because eggs and seafood are nutrient-dense foods, provide
important nutrients, and are specifically recommended by the Dietary
Guidelines, 2020-2025 for inclusion in a healthy dietary pattern, we
consider that it is appropriate for these foods to meet the updated
``healthy'' criteria. For these reasons, we are not proposing to
include a limit on dietary cholesterol as part of the updated criteria
for ``healthy.'' We seek comments on our proposed approach to dietary
cholesterol, including any data showing that the proposed saturated fat
limit does not adequately limit dietary cholesterol, or any data
indicating that foods containing lower saturated fat levels and higher
cholesterol levels (i.e., seafood and eggs) should not bear the
``healthy'' nutrient content claim.
3. Infants and Children Under Two Years of Age
    In developing updates to the criteria for ``healthy,'' we have also
considered whether the proposed definition should be extended to cover
foods targeted to those age groups. Defined nutrient content claims
currently apply to foods intended for adults and children 2 years of
age and older. With the exception of claims on the percent of the
Reference Daily Intake (RDI) for vitamins and minerals, nutrient
content claims currently cannot be made on foods intended specifically
for use by infants and children less than 2 years of age (e.g., jarred
baby foods, fruit pouches, toddler snack puffs) unless the claim is
explicitly provided for in the regulations for each individual claim
(21 CFR 101.13(b)(3)). Thus, as with most other nutrient content
claims, the current definition for the nutrient content claim
``healthy'' does not include provisions for foods intended specifically
for use by infants and children less than 2 years of age.
    Our tentative conclusion is to continue to limit the use of the
claim to foods directed to adults and children 2 years of age and
older. As described in section IV.C. (``Need to Update `Healthy' ''),
we relied primarily on the science articulated in the Dietary
Guidelines, 2020-2025 in developing the specific criteria on which to
base the definition of ``healthy.'' Historically, the Dietary
Guidelines have been directed to adults and children 2 years of age and
older. The Dietary Guidelines, 2020-2025 highlights the importance of
encouraging healthy dietary patterns at every life stage, and have
included new recommendations for healthy dietary patterns for infants
and children younger than 2 years of age in this lifespan approach.
Infants and children younger than 2 years of age have specific
nutritional needs that apply to their particular life stages and their
dietary recommendations are different from the recommendations for
other age groups. In our last update to the Nutrition Facts label (81
FR 33742), we established Daily Values (DVs) specifically for infants 7
through 12 months and children 1 through 3 years of age. The science
underlying the recommended intake levels of individual nutrients
demonstrates the specific nutritional needs of infants and children in
this life stage. Evaluating the specific nutritional needs of this
population can help us in determining whether it is appropriate to
extend use of the claim ``healthy'' to foods directed at infants and
children younger than 2 years of age. We intend to consider the
scientific information discussed in the Dietary Guidelines, 2020-2025,
as well as information from other sources, as we evaluate whether
specific criteria can be developed for foods targeted to infants and
children in those age groups for use in the definition of ``healthy.''
Because we are continuing to evaluate the information on the
nutritional needs of this life stage, at this time, we are not
proposing that the updated definition of ``healthy'' apply to foods
targeted to infants and children under 2 years of age.

B. Description of the Proposed Regulation

1. Terms Subject to Definition
    ``Healthy'' is a broad term that can have connotations beyond the
nutritional properties of a food. This proposed rule would define
``healthy'' as a nutrient content claim only when it is used in a
nutritional context; in other words, the proposed criteria would only
apply when ``healthy'' is used on a label or in labeling and other
information, such as other claims, images, or vignettes, about the
nutrition content of the food is also present somewhere on the
labeling. For example, if the word ``healthy'' is used above a picture
of vegetables or alongside another nutrient claim such as ``0g of
fat,'' that would clearly place it in the nutritional context. If,
however,

the word ``healthy'' was used on a label to say ``our manufacturing
processes support a healthy planet'' with an adjacent picture of the
earth, that would not be in the nutritional context. Under proposed
Sec.  101.65(d)(1), this regulation would cover labeling claims that
are implied nutrient content claims because they suggest that a food
may help consumers maintain healthy dietary practices because of its
nutrient content, where there is also implied or explicit information
about the nutrition content of the food (other than required
disclosures, such as the Nutrition Facts Label) elsewhere on the label
or in labeling.
    We determined in the 1994 rule that the term ``healthy''
constitutes an implied nutrient content claim only when it appears on
the label or labeling of a food in a nutritional context (59 FR 24232
at 24234 to 24235). We first determined that the term ``healthy'' does
not inherently imply the absence or presence of a nutrient in a
particular amount, or that the nutrient content of the food would be
helpful to consumers in structuring a diet that conforms to the Dietary
Guidelines. Rather, such inferences are likely to be drawn only if the
term ``healthy'' is accompanied by additional language or graphic
material or is otherwise presented in a context that explicitly or
implicitly suggests that the food has a particular nutrient content.
Based on this reasoning, we concluded that the nutritional context is a
critical factor as to whether ``healthy'' is used as an implied
nutrient content claim.
    We reaffirm our position in the 1994 rule that ``healthy'' is only
an implied nutrient content claim when used in a nutritional context,
as described above. However, we propose some minor revisions to Sec.
101.65(d)(1)(ii) defining implied nutrient content claims. Under the
existing regulation, labeling claims are implied nutrient content
claims when they are made in connection with an explicit or implicit
claim or statement about a nutrient (such as ``healthy, contains 3
grams of fat'').
    While we want to ensure that the regulation only reaches claims
that are made in a nutritional context, based on our years of
experience with the current claim, we think the existing language may
be too narrow and not reach all information about nutritional context.
Further, because this proposed rule would expand the criteria for
``healthy'' to incorporate food group requirements in addition to
individual nutrients to limit, we want to ensure that the regulation
encompasses the full range of nutrition information covered by the
rule. Based on these considerations, we propose revising the existing
text to broaden the description of what a nutritional context entails.
We seek comment on the definition of nutritional context provided here.
    Specifically, we propose revising Sec.  101.65(d)(1)(i) and (ii) to
appear as Sec.  101.65(d)(1). Proposed Sec.  101.65(d)(1), as revised,
would no longer require that an implied nutrient content claim be used
``in connection with an explicit or implicit claim or statement about a
nutrient.'' Instead, we propose in Sec.  101.65(d)(1) that ``healthy''
constitutes a nutrient content claim where the term ``healthy'' is used
to characterize the food itself and ``where there is also implied or
explicit information about the nutrition content of the food.'' This
clarifies that the information on the label that places use of the
claim ``healthy'' into a nutritional context would not necessarily be
immediately adjacent to the implied nutrient content claim, as in the
``healthy, contains 3 grams of fat'' example. Instead, we propose to
make clear that any information on the label or labeling that puts the
term ``healthy'' into a nutritional context would make ``healthy'' an
implied nutrient content claim when it is used to characterize the
food. For example, where ``healthy'' appears on the front of a cereal
product that is described elsewhere on the label or labeling as high in
dietary fiber (e.g., on the back of the package, or on a website), the
``healthy'' claim would constitute a nutrient content claim under Sec.
101.65(d). There may also be instances where the use of a graphic on
the label of a food bearing ``healthy'' would place the term in a
nutritional context; for example, if the label on a can of beans
labeled ``healthy'' also used the MyPlate symbol (which graphically
puts the food groups together in the context of an overall dietary
pattern, as a translation of the Dietary Guidelines) or other front of
pack labeling (such as the ``Facts Up Front'' labeling program) to
imply that the product meets nutritional needs (Ref. 32). In addition,
some brands include ``healthy'' or related words in their brand name,
which could be considered an implied nutrient content claim if any
other information on the label or labeling puts the term ``healthy''
into a nutritional context--for example, if a food product included
``healthy'' within the brand name also used the ``low sodium'' nutrient
content claim. FDA considers food labels and labeling as a whole and
will consider the context of statements made in labels and labeling to
determine whether a product bears a ``healthy'' implied nutrient
content claim.
    We also propose revising the codified text in Sec.  101.65(d)(1) to
no longer require that the accompanying material be a ``claim or
statement about a nutrient.'' It would instead require that it be
``information about the nutrition content of the food.'' This text is
still intended to ensure that the regulation only applies where a
``healthy'' claim is used in a nutritional context. However, it would
not limit the accompanying material on the labeling to phrases
declaring presence/level of a specific nutrient (as in the ``healthy,
contains 3 grams of fat'' example), but include any material stating or
implying that the nutrient content of the food would be helpful to
consumers in structuring a diet that is supported by current dietary
recommendations. For example, if a cereal package bore the claim
``healthy'' as a descriptor of the cereal, and its labeling elsewhere
stated, ``Provides all of your child's essential vitamins and
minerals,'' this would constitute an implied nutrient content claim,
because in that context, the ``healthy'' claim suggests that the
nutrient content of the food would be helpful in structuring a diet
that conforms to current dietary recommendations. Information about the
nutrition content of the food need not make explicit references to
nutrients but can refer to nutrients by implication. For example, if
the label on a food product characterizes food using the term
``healthy'' and elsewhere stated that the product is ``made with whole
grain ingredients,'' or ``made with real fruits and vegetables,'' or
``contains a variety of nuts,'' this would put ``healthy'' in a
nutritional context because the labeling implies that the food should
contain nutrients commonly associated with and contributed by those
food components.
    We therefore propose that the updated Sec.  101.65(d)(1) state that
it 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. Additionally, because the language in Sec.  101.13(b)(2)(ii)
parallels the definition of ``healthy'' in Sec.  101.65, we are also
proposing to update the language in Sec.  101.13(b)(2)(ii) to provide
that an implied nutrient content claim 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).

    Under the proposed regulation, ``healthy,'' when used outside of a
nutritional context, would not be an implied nutrient content claim.
However, even outside of the nutritional context, we have the authority
under the misbranding provisions at section 403(a) of the FD&C Act, to
ensure that ``healthy'' is not used in a misleading manner. The
proposed regulation also does not address use of the term ``healthy''
when used as part of an implied health claim (e.g., ``heart healthy'')
instead of a nutrient content claim. See 21 CFR 101.14 for information
on the use of express and implied health claims.
2. Food Group Equivalents
    As explained in section VI.A (``Overview of Approach''), a food
group equivalent is the amount of a food from a particular food group
that must be contained in a food product for it to bear the ``healthy''
claim. Proposed Sec.  101.65(d)(2) would define a ``food group
equivalent'' as equal to the following:
     A food group equivalent of a vegetable would be equal to
one \1/2\ c-eq vegetables.
     A food group equivalent of a fruit would be equal to one
\1/2\ c-eq fruit.
     A food group equivalent of grain would be \3/4\ oz-eq
whole grain.
     A food group equivalent of dairy would be equal to \3/4\
c-eq dairy.
     A food group equivalent of protein would:
    [cir] For game meats, such as deer, rabbit, quail, and wild geese,
be 1 \1/2\ oz-eq; and
    [cir] For seafood; eggs; beans, peas, and soy products; and nuts
and seeds, be 1 oz-eq.
    We have divided the protein foods group into these subgroups, which
are distinct from the Dietary Guidelines, 2020-2025 subgroups, as
explained further in section V.B.3.b (``Individual foods'').
    We are not proposing a food group equivalent for oils, because, as
explained in section V.B.3.b (``Individual foods''), we are only
proposing that certain oil-based foods meet the criteria for healthy,
and oil used in other foods does not contribute to eligibility for
bearing the ``healthy'' claim.
    These food group equivalents are indicated in table 1.

                     Table 1--Food Group Equivalents
------------------------------------------------------------------------
  Food group and/or subgroup             Food group equivalent
------------------------------------------------------------------------
Vegetables...................  \1/2\ cup equivalent vegetable.
Fruits.......................  \1/2\ cup equivalent fruit.
Grains.......................  \3/4\ ounce (oz) equivalent whole grain.
Dairy........................  \3/4\ cup equivalent dairy.
Protein Foods................  Game meats.
                               1\1/2\ oz equivalent.
                               Seafood.
                               1 oz equivalent.
                               Egg.
                               1 oz equivalent.
                               Beans, peas, and soy products.
                               1 oz equivalent.
                               Nuts and seeds.
                               1 oz equivalent.
------------------------------------------------------------------------

    As noted in section VI.A (``Overview of Approach''), the c-eq and
oz-eq amounts are based on the amounts discussed in the Dietary
Guidelines, 2020-2025. For vegetables and fruits, a 1 c-eq is: 1 cup
raw or cooked vegetable or fruit, 1 cup 100 percent vegetable or fruit
juice, 2 cups leafy salad greens, or \1/2\ cup dried fruit or
vegetable. For grains, a 1 oz-eq is: \1/2\ cup cooked whole grain rice,
whole grain pasta, or cereal; 1 oz dry whole grain pasta or rice; 1
medium (1 oz) slice whole grain bread, tortilla, or flatbread; 1 oz of
ready-to-eat whole grain cereal. For dairy, a 1 c-eq is: 1 cup fat-free
or low-fat milk, yogurt or lactose-free versions, or fortified soy
beverage or yogurt alternatives; 1\1/2\ oz natural cheese or 1 oz
processed cheese. For protein foods, a 1 oz-eq is: 1 oz game meat or
seafood; 1 egg; \1/4\ cup cooked beans or tofu; 1 tbsp nut or seed
butter; \1/2\ oz nuts or seeds (Refs. 1 and 22).
    This means, for example, that a \1/2\ cup portion of fresh or
frozen green beans and a 1 cup portion of raw spinach would both
constitute \1/2\ c-eq vegetables. A \1/2\ cup portion of fresh or
frozen fruit, \1/2\ cup portion of 100 percent orange juice, and a \1/
4\ cup portion of raisins (a dried fruit) would all be equal to a \1/2\
c-eq of fruit. A slice of whole wheat bread and a \1/2\ cup portion of
cooked brown rice would both be equal to a 1 oz-eq whole grains. A 6-
ounce portion of yogurt would be equivalent to \3/4\ c-eq dairy. An
ounce portion of walnuts and 2 tablespoons of peanut butter would be
equal to 2 oz-eq of protein foods. A \1/2\ cup portion of black beans
would be equal to 2 oz-eq of protein foods (Refs. 1 and 22). Examples
of foods and their amounts that meet the food group equivalent
requirements are included in a table in the proposed codified language
for Sec.  101.65(d)(2).
3. Covered Products
    Under proposed Sec.  101.65(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 if the food meets
the requirements laid out in proposed Sec.  101.65(d)(3)(i)-(vi). These
terms are unchanged from the existing regulation at Sec.  101.65(d);
see the 1994 ``healthy'' final rule for a more detailed discussion of
how these terms were selected (59 FR 24232 at 24235). However, we seek
comments on whether there are any other terms synonymous with
``healthy'' that we should consider as we finalize this rulemaking.
    Foods that may bear the nutrient content claim ``healthy'' under
the proposed updated criteria are broken out into several categories:
(1) raw, whole fruits and vegetables; (2) individual food products; (3)
combination foods, which encompasses mixed products, main dish
products, and meal products; and (4) plain water. The specific
requirements for these foods are described in more detail in the
following sections.

    Table 2--Eligible Products for ``Healthy'' Nutrient Content Claim
------------------------------------------------------------------------
        Eligible products for ``healthy'' nutrient content claim
-------------------------------------------------------------------------
                                               Criteria for bearing
                Product                         ``healthy'' claim
------------------------------------------------------------------------
Raw, whole fruits and vegetables.......  No additional criteria; all
                                          raw, whole fruits and
                                          vegetables may bear the claim.
Individual food products...............  At least 1 food group
                                          equivalent per RACC from 1
                                          food group, and Nutrients to
                                          limit.
Mixed products.........................  At least \1/2\ food group
                                          equivalent each from at least
                                          2 different food groups, and
                                          Nutrients to limit.
Main dish as defined at 21 CFR           At least 1 food group
 101.13(m).                               equivalent each from at least
                                          2 different food groups, and
                                          Nutrients to limit.
Meal as defined at 21 CFR 101.13(l)....  At least 1 food group
                                          equivalent each from at least
                                          3 different food groups, and
                                          Nutrients to limit.
Water..................................  Plain water and plain,
                                          carbonated water may bear the
                                          claim.
------------------------------------------------------------------------

a. Raw, Whole Fruits and Vegetables
    A key objective of the updated criteria is to ensure conformity
with current nutrition science and Federal dietary guidance by, among
other things, ensuring that the nutrient dense foods recommended by the
Dietary Guidelines, 2020-2025 are eligible to bear the ``healthy''
claim. Precluding such foods from bearing the ``healthy'' claim could
undermine an important element of the claim, as the purpose of the
healthy claim is to identify foods that, because of their nutrient
content, may help consumers maintain healthy dietary practices,
consistent with current nutrition science and Federal dietary guidance.
Healthy dietary patterns described by the Dietary Guidelines, 2020-2025
include vegetables from all vegetable subgroups (dark green, red and
orange, beans, peas, and lentils, starchy, and other) and fruits,
especially whole fruits. Vegetables contribute many nutrients to the
diet including dietary fiber, potassium, vitamin A, vitamin C, vitamin
K, copper, magnesium, vitamin E, vitamin B6, folate, iron, manganese,
thiamin, niacin, and choline, while fruits are important contributors
of dietary fiber, potassium, and vitamin C. The Dietary Guidelines have
consistently emphasized consumption of fruits and vegetables (Ref. 15),
and diets high in fruits and vegetables have been associated with
specific health benefits, including lower occurrence of coronary heart
disease and some cancers (Ref. 16 and 59 FR 24232 at 24244). Despite
their importance to a healthy dietary pattern, average intake of
vegetables and fruits is below recommended levels among nearly all age-
sex groups (Ref. 1).
    While we are proposing food group equivalent and nutrient-to-limit
requirements for most foods, we are not proposing to subject raw, whole
fruits and vegetables to the criteria. For the purpose of this rule,
``raw, whole'' means whole fruits and vegetables that have not been
processed, such as whole apples, bananas, or carrots. Raw, whole fruits
and vegetables automatically qualify for use of the claim, regardless
if they meet the criteria required of other foods. As discussed in the
Dietary Guidelines 2020-2025, most of the U.S. population (around 80
percent) does not meet the dietary intake recommendation for fruits and
an even larger percentage (around 90%) do not meet the intake
recommendation for vegetables. Excluding some raw, whole fruits and
vegetables from qualifying for the proposed, updated ``healthy''
definition is not supported by scientific evidence or current dietary
guidance. Therefore, we tentatively conclude that raw, whole fruits and
vegetables do not need to contain a certain amount of fruit or
vegetable to contribute to a healthy dietary pattern--for example, a
strawberry should be able to bear the ``healthy'' claim even though one
strawberry does not constitute a \1/2\ c-eq of fruit. Moreover, raw,
whole fruits and vegetables are often sold without packaging or labels.
While these products typically do not carry label claims, they may
appear on other materials in the stores and elsewhere that may
constitute labeling. We therefore tentatively conclude that raw, whole
vegetables and fruits should be able to meet the ``healthy'' criteria
without meeting a food group equivalent threshold. We seek comment on
our tentative conclusions.
    We also tentatively conclude that it would be inappropriate to
apply nutrient-to-limit criteria to raw, whole vegetables and fruits.
For example, sodium and added sugars are not a concern for raw, whole
fruits and vegetables because they contain no added ingredients.
Furthermore, including a limit for saturated fat would actually
disqualify certain vegetables, such as whole avocados, which are
vegetables containing beneficial nutrients and are sources of
unsaturated fat, from meeting the updated ``healthy'' criteria.
    For these reasons, we are proposing a narrow exception to the
requirements for food group equivalents and nutrients to limit for raw,
whole fruits and vegetables. We propose allowing all raw, whole fruits
and vegetables to bear the implied nutrient content claim ``healthy,''
without any additional requirements for food group equivalents or
nutrients to limit.
    We do not propose to include processed fruits and vegetables, such
as canned, frozen, dried, or pureed fruits and vegetables, within this
exemption, though many may still meet the criteria to bear ``healthy.''
For purposes of this claim, fruits and vegetables that have been cut
and packaged for sale, such as cantaloupe pieces cut and packaged for
sale in a supermarket are considered processed. We note that fruits and
vegetables that have been solely cut and packaged for sale would
generally qualify for use of the claim under the criteria for
individual foods, as raw fruits and vegetables do not exceed the
nutrient criteria and would meet the food group equivalent requirement.
For example, plain frozen fruit or vegetables would not exceed the
nutrient-to-limit criteria and would meet the food group equivalent
requirement. It is possible, though, that there are a few forms of
fruit and vegetable products that may have RACCs that are smaller than
the size of the required food group equivalent requirement. For
example, frozen avocado pieces, specifically, may have a RACC that does
not meet the FGE amount criteria of \1/2\ c fruit. We request comment
on whether there are any other fruit or vegetable products for which
the RACC size may have an impact in terms of qualifying for the claim
and we request comment on ways we could address how those products,
including frozen avocados, could qualify for the claim. Many processed
fruits and vegetables are packaged and sold in a form that makes it
appropriate to apply

the food group equivalent requirement to these kinds of food to ensure
the product contains a meaningful amount of the fruit and/or vegetable.
For example, it is appropriate to require that canned fruit products
contain a certain amount of fruit per serving in order to bear the
``healthy'' claim because they contain additional ingredients (e.g.,
sugar solution) which may impact whether the product has enough fruit
per serving to meet the food group equivalent requirement. Furthermore,