Document ID: FDA-2016-D-2335-1152
Agency: fda
Document Type: Proposed Rule
Title: Food Labeling: Nutrient Content Claims; Definition of Term ‘‘Healthy’’
Posted Date: 2022-09-29T04:00Z

[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Proposed Rules]
[Pages 59168-59202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20975]

[[Page 59167]]

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  

[[Page 59168]]

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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, 240-402-7500.
     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, 240-402-7500.
    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, 240-402-1450, 
[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

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    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

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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

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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.
------------------------------------------------------------------------

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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

[[Page 59173]]

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

[[Page 59174]]

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

[[Page 59175]]

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

[[Page 59176]]

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).

[[Page 59177]]

    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

[[Page 59178]]

(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

[[Page 59179]]

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.

[[Page 59180]]

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

[[Page 59181]]

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,

[[Page 59182]]

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).

[[Page 59183]]

    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.

[[Page 59184]]

    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

[[Page 59185]]

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

[[Page 59186]]

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

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

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

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

[[Page 59187]]

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

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

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

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

[[Page 59188]]

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

[[Page 59189]]

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

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

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

[[Page 59190]]

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

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

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

[[Page 59191]]

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

[[Page 59192]]

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

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

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

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

[[Page 59193]]

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

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

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

[[Page 59194]]

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

[[Page 59195]]

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

VII. Proposed Effective and Compliance Dates

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

VIII. Preliminary Economic Analysis of Impacts

A. Introduction

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

B. Summary of Costs and Benefits

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

[[Page 59196]]

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

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

[[Page 59197]]

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

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

IX. Analysis of Environmental Impact

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

X. Paperwork Reduction Act of 1995

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

[[Page 59198]]

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

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

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

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

XI. Federalism

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

[[Page 59199]]

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

XII. Consultation and Coordination With Indian Tribal Governments

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

XIII. References

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

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

[[Page 59200]]

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

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and record keeping 
requirements.

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

PART 101--FOOD LABELING

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

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

Sec.  101.13  Nutrient content claims--general principles.

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

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

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

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

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

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

[[Page 59201]]

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

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

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

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

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

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

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

[[Page 59202]]

 
(3) A food group equivalent of dairy and              5% DV             30% DV  20% DV; or 25% DV if the protein
 a food group equivalent each of fruit,                                          is a game meat, seafood, or
 vegetable, and/or protein.                                                      egg.
(4) A food group equivalent of dairy, a              10% DV             30% DV  20% DV; or 25% DV if the protein
 food group equivalent of whole grain,                                           is a game meat, seafood, or
 and a food group equivalent of fruit,                                           egg.
 vegetable, and/or protein.
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    (vi) Plain water and plain carbonated water without any flavoring 
or additional ingredients.
    (4) Each manufacturer of a food (other than raw, whole fruits, raw 
whole vegetables, water, and individual foods where the standard 
information required on the food label, such as the list of 
ingredients, provides sufficient information to verify that the food 
meets the food group equivalent requirements to bear the claim) that 
bears the implied nutrient content claim ``healthy'' must make and keep 
written records (e.g., analyses of databases, recipes, formulations, 
information from recipes or formulations, or batch records) to verify 
that the food meets the food group equivalent requirements of paragraph 
(d)(2) of this section where the food group equivalent contained in the 
product is not apparent from the label of the food. These records must 
be kept for a period of at least 2 years after introduction or delivery 
for introduction of the food into interstate commerce. Such records 
must be provided to FDA upon request, during an inspection, for 
official review and photocopying or other means of reproduction. 
Records may be kept either as original records, true copies (such as 
photocopies, pictures, scanned copies, microfilm, microfiche, or other 
accurate reproductions of the original records), or electronic records 
which must be kept in accordance with part 11 of this chapter. These 
records must be accurate, indelible, and legible.

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