`[Federal Register Volume 89, Number 248 (Friday, December 27, 2024)]
[Rules and Regulations]
[Pages 106064-106165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29957]



[[Page 106063]]

Vol. 89

Friday,

No. 248

December 27, 2024

Part V





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''; 
Final Rule

  Federal Register / Vol. 89 , No. 248 / Friday, December 27, 2024 / 
Rules and Regulations  

[[Page 106064]]


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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, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is issuing this 
final rule updating 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 final rule revises the requirements for 
when the term ``healthy'' can be used as an implied nutrient content 
claim in the labeling of human food products to help consumers identify 
foods that are particularly useful as the foundation of a nutritious 
diet that is consistent with dietary recommendations.

DATES: This rule is effective February 25, 2025. The compliance date of 
this final rule is February 25, 2028.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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.

FOR FURTHER INFORMATION CONTACT: With regard to the final rule: Vincent 
de Jesus, Office of Nutrition and Food Labeling (HFS-803), Human Foods 
Program, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD, 20740, 240-402-1450; Denise See or Barbara Little, Office of 
Policy, Regulations, and Information (HFS-024), Human Foods Program, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
240-402-2378.
    With regard to the information collection: Domini Bean, 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 Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of the Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. General Comments
    C. Food Group Equivalents
    D. Nutrients to Limit
    E. Combination Foods (i.e., Mixed Products, Main Dish Products, 
and Meal Products)
    F. Beverages
    G. The Term ``Healthy'' and Related Terms or Derivatives of 
``Healthy''
    H. Nutritional Context
    I. Records Requirements
    J. Effective and Compliance Dates
    K. Legal Comments
    L. Miscellaneous Comments
VI. Economic Analysis of Impacts
    A. Introduction
    B. Overview of Benefits, Costs, and Transfers
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Final Rule

    This final rule updates the requirements for when the term 
``healthy'' can be used as an implied nutrient content claim in the 
labeling of human food products to help consumers identify foods that 
can serve as the foundation of a nutritious diet that is consistent 
with current dietary recommendations. Consumers rely on food labels 
when navigating the marketplace to make informed choices about the 
foods they purchase for themselves and their families. FDA plays an 
important role in ensuring that the labels or labeling of food for 
human consumption, including claims on labels or labeling that market a 
food, are accurate, truthful, and not misleading. 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 about the level of nutrients in the product. 
In particular, such a claim implies that the nutrient content of the 
food may help consumers maintain healthy dietary practices. Given that 
nutrition science has evolved since the 1990s, this final rule updates 
the definition of ``healthy'' to be consistent with current nutrition 
science and Federal dietary guidance to help ensure that consumers have 
access to more complete, accurate, and up-to-date information on food 
labels. This final rule is also consistent with the longstanding 
purpose of this implied nutrient content claim to indicate that the 
nutrient levels of a food may help consumers maintain healthy dietary 
practices and furthers FDA's goals in accordance with its statutory 
mandate to prevent misleading labeling and reduce consumer confusion 
that can result from the use of inconsistent definitions for nutrient 
content claims.
    In addition, updating the ``healthy'' nutrient content claim is one 
initiative action listed in the White House National Strategy on 
Hunger, Nutrition, and Health under the pillar of empowering all 
consumers to make and have access to healthy choices (Ref. 6). FDA, as 
part of this whole-of-government approach, broadly seeks to help reduce 
the burden of diet-related chronic diseases. Doing so will advance 
health equity, because diet-related chronic diseases are experienced 
disproportionately by certain racial and ethnic minority groups and 
those with lower socioeconomic status. For further discussion regarding 
the scope of the problem Americans face from diet-related chronic 
diseases, please see the proposed rule, 87 FR 59168 at 59170. We are 
committed to accomplishing these goals, in part, by prioritizing 
nutrition initiatives that can help improve dietary patterns in the 
United States. An important aspect of reducing the burden of diet-
related chronic diseases, as well as advancing health equity, is 
helping consumers access nutrition information that allows them to 
identify healthier choices. As discussed further in section V. 
(``Comments on the Proposed Rule and FDA Response''), nutrient content 
claims, such as ``healthy,'' as well as other claims made on labels or 
in the labeling of foods act as quick signals on food packages. These 
statements may help consumers, particularly those with lower nutrition 
or health literacy, quickly and easily identify foods that can be the 
foundation of a healthy dietary pattern. Additionally, as discussed 
further in section V. (``Comments on the Proposed Rule and

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FDA Response''), our review of the products available in the current 
marketplace demonstrates that the updated ``healthy'' criteria allow 
affordable, accessible, and culturally preferred \1\ nutrient-dense 
foods within different food groups and subgroups to bear the 
``healthy'' claim, including frozen, canned, dried, and other shelf-
stable products. This final rule is one part of FDA's broader 
commitment to help reduce diet-related chronic diseases and also to 
advance health equity by helping consumers to identify foods that can 
be the foundation of a healthy dietary pattern. While there has been 
consistency in many of the recommendations in Federal dietary 
guidelines and the underlying nutrition science on which they are 
based, we intend to remain aligned with the most current nutrition 
science reflected in Federal dietary guidelines and will continue to 
update our regulations and policies, as appropriate.
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    \1\ The term ``culturally preferred foods'' is used here to 
describe safe and nutritious foods that meet the diverse tastes and 
needs of customers based on their cultural identity (Ref. 46).
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B. Summary of the Major Provisions of the Final Rule

    This final rule updating the definition of ``healthy'' includes 
provisions that:
     Establish parameters for use of the term ``healthy'' or 
derivative terms ``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 suggests that a food, because of its nutrient 
content, may help consumers maintain healthy dietary practices, where 
there is also implied or explicit information about the nutrition 
content of the food on the label or in the labeling (Sec.  101.65(d)(1) 
and (3)) (21 CFR 101.65(d)(1) and (3))).
     Establish a framework based on food groups and nutrients 
to limit (NTL) for the ``healthy'' claim.
     Establish that ``food group,'' for the purposes of the 
``healthy'' claim, refers to the groups of foods recommended in the 
Dietary Guidelines, 2020-2025 (for adults and children 2 years of age 
and older), which are vegetables, fruits, dairy, grains, protein foods, 
as well as oils (Sec.  101.65(d)(2)).
    [cir] 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 include oils as a 
food group for purposes of this rule.
    [cir] For purposes of this rule, when we refer to foods as 
recommended or encouraged by the Dietary Guidelines, 2020-2025, we are 
referring to only those foods that are recommended or encouraged for 
adults and children 2 years of age or older because that is the 
population for which the claim is intended.
     Establish food group equivalents (FGEs) that identify 
qualifying amounts of foods from each food group based on nutritional 
content (Sec.  101.65(d)(2)).
     An FGE contains the following: (Sec.  101.65(d)(2))
[cir] Vegetable--1/2 cup equivalent (c-eq)

[cir] Fruit--1/2 cup equivalent
[cir] Grains--3/4 ounce (oz) equivalent whole grain
[cir] Dairy--2/3 cup equivalent
[cir] Protein foods:
[squf] Game meat--1\1/2\ oz equivalent
[squf] Seafood--1 oz equivalent
[squf] Egg--1 oz equivalent
[squf] Beans, peas, or lentils--1 oz equivalent
[squf] Nuts and seeds, or soy products--1 oz equivalent

     Require that, to bear a claim subject to this rule, 
individual food products, mixed products, main dishes, and meals must 
meet FGEs and specific limits for added sugars, saturated fat, and 
sodium based on a percentage of the Daily Value (DV) for these 
nutrients. To bear a claim that is subject to this rule:
    [cir] An individual food that has a reference amount customarily 
consumed (RACC, used to determine serving size), greater than 50 grams 
(g) or greater than 3 tablespoons (Tbsp) and meets the following 
conditions per RACC; or an individual food that has a RACC of 50 g or 
less or 3 Tbsp or less and meets the following conditions per 50 g of 
food: (Sec.  101.65(d)(3)(ii)(A) and (B))

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[GRAPHIC] [TIFF OMITTED] TR27DE24.002

    [cir] A mixed product that meets the following conditions per RACC 
(Sec.  101.65(d)(3)(iii)):

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[GRAPHIC] [TIFF OMITTED] TR27DE24.003

    [cir] A main dish product as defined in Sec.  101.13(m) (21 CFR 
101.13(m)) that meets the following conditions per labeled serving: 
(Sec.  101.65(d)(3)(iv))
[GRAPHIC] [TIFF OMITTED] TR27DE24.004

    [cir] A meal product as defined in Sec.  101.13(l) that meets the 
following conditions per labeled serving: (Sec.  101.65(d)(3)(v))
[GRAPHIC] [TIFF OMITTED] TR27DE24.005

     Provide that individual foods or mixed products that are 
comprised of one or more of the following foods encouraged by the 
Dietary Guidelines, with no other added ingredients except for water: 
vegetable; fruit; whole grains; fat-free and low-fat dairy; lean meat, 
seafood, eggs, beans, peas, lentils, nuts and seeds, automatically 
qualify (i.e., without having to meet the FGE and nutrients to limit 
(NTL) requirements) for the ``healthy'' claim because of their nutrient 
profile and positive contribution to an overall healthy diet. Sec.  
101.65(d)(3)(i))
     Provide that all water, tea, and coffee with less than 5 
calories per RACC and per labeled serving automatically qualify for the 
``healthy'' claim. (Sec.  101.65(d)(3)(vi))
     Require the establishment and maintenance of certain 
records for foods bearing the ``healthy'' claim where the FGE contained 
in the product is not apparent from the label of the food. The records 
must be kept for a period of at least 2 years after introduction or 
delivery for introduction of the food into interstate commerce. During 
an inspection, such records must be provided to FDA upon request for 
official review and photocopying or other means of reproduction. (Sec.  
101.65(d)(4))

C. Legal Authority

    We are issuing this final 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 for 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 more 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 (CVD) and type 2 diabetes. Quantifiable benefits 
of the rule are the estimated reduction over time in all-cause 
mortality stemming

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from consumers that rely upon the ``healthy'' implied nutrient content 
claim selecting and consuming more healthful foods. Discounted at 3 
percent over 20 years, the mean present value of benefits is estimated 
at $686 million, or $46 million annualized. This is calculated through 
the inverse association between a Healthy Eating Index score and all-
cause mortality (Ref. 44). 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 $403 million, or $27 
million annualized. Potential costs of rebranding certain foods are 
discussed qualitatively. Net benefits are estimated at $283 million, or 
$19 million annualized.

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[GRAPHIC] [TIFF OMITTED] TR27DE24.006


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III. Background

A. Need for the Regulation/History of This Rulemaking

    In the Federal Register of May 10, 1994 (59 FR 24232), we published 
a final rule (the 1994 rule or original 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. The definition established 
in 1994 (original definition) was linked to certain requirements in the 
Nutrition Facts label at Sec.  101.9 (21 CFR 101.9) and serving size 
regulations at Sec.  101.12 (21 CFR 101.12) that were in effect in 
1994. The 1994 rule established 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 1994 rule, these conditions 
included specific criteria for nutrients that must be met for the food 
to bear such claims. These criteria included limits on total fat, 
saturated fat, cholesterol, and sodium, and minimum amounts (10% of DV) 
of nutrients whose consumption is encouraged, such as vitamin A, 
vitamin C, calcium, iron, protein, and dietary fiber. Under the 1994 
rule, foods must meet all limits and contain the minimum amount of at 
least one nutrient to encourage (NTE) to bear the ``healthy'' claim. 
The required nutrient criteria varied for certain food groups (e.g., 
different criteria for seafood, game meat, and raw fruits and 
vegetables). The 1994 rule also linked the claim with an explicit or 
implicit claim or statement about a nutrient (e.g., ``healthy, contains 
3 grams of fat'').
    Nutrition science and Federal dietary guidance have evolved since 
1994. 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 (codified 
primarily at part 101 (21 CFR part 101)) 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 regarding dietary patterns and health outcomes 
supports a mandatory declaration of added sugars (Sec.  
101.9(c)(1)(iii)). 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.'' The NFL Final Rule and the Serving Size Final Rule reflect 
the nutrition science in the Dietary Guidelines, other consensus 
reports, national survey intake data, and research regarding consumer 
use and understanding of the food label.
    As the Dietary Guidelines, 2020-2025 explains, current nutrition 
science focuses ``on consuming a healthy dietary pattern'' (Ref. 1). 
Current nutrition science emphasizes nutrient-dense foods, such as 
fruits, vegetables, and whole grains, as core 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 or no 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 were 
not able to bear the ``healthy'' claim under the 1994 rule (e.g., 
salmon due to fat amounts). Further, the 1994 rule permitted 
manufacturers to use the claim ``healthy'' on some foods that, based on 
updated nutrition science and Federal dietary guidance, contain levels 
of nutrients that would not help consumers maintain healthy dietary 
practices (e.g., certain foods that are high in added sugars). We have 
long recognized the need to update the definition for the implied 
nutrient content claim ``healthy'' to be consistent with current 
nutrition science and Federal dietary guidance. Consequently, in the 
Federal Register of September 29, 2022 (87 FR 59168), we issued a 
proposed rule to amend the definition of ``healthy'' to ensure that 
foods bearing the claim are foods that may help consumers maintain 
healthy dietary practices, consistent with current nutrition science 
and Federal dietary guidance; in other words, nutrient-dense foods that 
are foundational to a healthy dietary pattern. The preamble to the 
proposed rule discussed, in some detail, the reasons why we felt it 
necessary to update the definition of ``healthy'' as an implied 
nutrient content claim (see 87 FR 59168 at 59169 through 59173).
    When FDA first defined healthy in 1994 (59 FR 24232), we concluded 
that ``the fundamental purpose of a `healthy' claim is to highlight 
those foods that, based on their nutrient levels, are particularly 
useful in constructing a diet that conforms to current dietary 
guidelines'' (59 FR 24232 at 24233). Under this framework, which is 
continued under this rule, foods that do not qualify for use of the 
claim are not deemed to be ``unhealthy'' or unable to provide any 
nutritional benefits to consumers. Nor does the healthy definition, as 
established in this rule, represent a determination by FDA that 
consumers should only choose foods that qualify for the ``healthy'' 
claim or completely avoid choosing foods that do not qualify for the 
``healthy'' claim. The current Dietary Guidelines, 2020-2025 (Ref. 1) 
focuses on the importance of a healthy dietary pattern as a whole and 
its role in promoting health, reducing risk of chronic diseases, and 
meeting nutrient needs. Although nearly all foods can be incorporated 
into a healthy dietary pattern to some extent, current nutrition 
science emphasizes nutrient-dense foods, such as fruits, vegetables, 
and whole grains, as core elements of a healthy dietary pattern (Ref. 
1). Moreover, foods that meet the requirements for ``healthy'' as 
defined in this rule are foods that, because of their overall nutrition 
profiles, can be the ``foundation'' or ``building blocks'' of a healthy 
dietary pattern recommended by the Dietary Guidelines.
    Foods that do not meet the requirements defined in this rule to 
bear the ``healthy'' claim could, however, have beneficial nutritional 
attributes and these nutritional attributes can be communicated to 
consumers in many different ways. For example, use of other nutrient 
content claims, such as ``low'' (e.g., ``low saturated fat'' in Sec.  
101.62(c) (21 CFR 101.62(c))) or ``high'' (Sec.  101.54(b) (21 CFR 
101.54(b))) can inform consumers interested in intake of specific 
nutrients. In addition, a food label can include health claims, which 
are different than nutrient content claims in that they show how a food 
or food component may reduce the risk of a disease or health-related 
condition. Other claims (e.g., structure/

[[Page 106071]]

function claims) can describe, for example, the role of a nutrient 
intended to affect the normal structure or function of the body. 
Additionally, dietary guidance statements are a type of voluntary 
labeling statement that can be used on labels that represent or suggest 
that an individual food or food group may contribute to or help 
maintain a nutritious dietary pattern. Dietary guidance statements 
provide manufacturers with a broad range of messages beyond 
characterizing the nutrient content of the food (compared with nutrient 
content claims such as ``healthy'') and can communicate to consumers 
that a food or food group may contribute to or help maintain a 
nutritious dietary pattern. Different nutrition labeling claims 
communicate different meanings to consumers, and there are different 
criteria for their use. However, certain statements may be considered 
more than one type of claim, depending on the context in which they are 
used and taken together with the labels or labeling as a whole. As 
such, that a food may qualify for another type of claim does not 
automatically make the food eligible for the ``healthy'' claim, just as 
that a food qualifies for the ``healthy'' claim does not mean a food 
will meet the requirements for other claims. The criteria for each of 
the different claims must be met to use that specific claim and 
manufacturers are free to use any applicable claims for which they 
qualify and make truthful and non-misleading statements on food labels 
or labeling.

B. Summary of Comments to the Proposed Rule

    We received approximately 400 comments on the proposed rule, each 
containing one or more comments on one or more provisions of the rule. 
We received comments from industry; trade organizations; consulting 
firms; law firms; academia; public health organizations; public 
advocacy groups; consumers; consumer groups; Congress, State, and local 
Governments; and other organizations. In section V. (``Comments on the 
Proposed Rule and FDA Response''), we summarize these comments, respond 
to them, and explain any revisions we made to the proposed rule. The 
topics addressed most frequently in the comments include:
     Many comments support the proposed rule on the grounds 
that it would help consumers make better, healthier choices, and 
generally improve the nutritional knowledge of the average consumer in 
the United States.
     Similarly, numerous comments support the proposed rule on 
the grounds that it could help combat the high rate of obesity and 
diet-related chronic diseases and illnesses in the Unites States.
     Although many comments support updating the ``healthy'' 
definition and acknowledge the need for consistency with current 
nutrition science and Federal dietary recommendations, particularly the 
Dietary Guidelines, a number of comments request changes to provide 
more flexibility and, according to the comments, increase the number of 
foods that could qualify for the ``healthy'' claim. Such comments range 
in scope, from small increases in the allowable nutrient levels to the 
addition of entire new sets of criteria.
     Many comments request that we simplify and streamline the 
criteria for combination foods (mixed products, meals, and main dishes) 
to allow more flexibility in formulations and recipes for combination 
foods recommended by the Dietary Guidelines.
     Several comments suggest entirely different, alternative 
frameworks for the definition of ``healthy'' such as changes to the FGE 
criteria, permitting NTE as part of the criteria, and changes that 
would allow products with a small RACC to use the claim.
     Other comments recommend changes, including both higher or 
lower limits, to the nutrient limits for added sugars, saturated fat, 
and sodium.
     Some comments also address other topics in the proposed 
rule, including some for which we specifically requested comments and 
information. For example, some comments discuss exemptions from the FGE 
criteria and/or nutrient limits for certain foods, such as fish/
seafood, certain plant-based proteins or plant-based beverages, tart 
fruits, and beverages other than plain water, such as coffee and tea. 
Other comments discuss bottled water containing other ingredients, such 
as flavors.

C. General Overview of the Final Rule

    We provide a detailed overview of the final rule above in section 
I.B (``Summary of the Major Provisions of the Final Rule''). In support 
of our consideration of the comments received on the proposed rule, we 
conducted reviews of databases of products available in the current 
marketplace to determine what foods in the marketplace would meet 
certain FGE and NTL criteria in the proposed rule (Ref. 2). As a result 
of comments received and, in some cases, also supported by the 
marketplace review we conducted to evaluate those comments, we have 
made several changes to the proposed criteria to provide additional 
flexibility, which will result in more foods qualifying to bear the 
``healthy'' claim while still aligning with current nutrition science 
and Federal dietary guidelines. Such changes include, but are not 
limited to, the following:
     The rule applies the ``healthy'' criteria to individual 
foods with a RACC of 50 g or less or 3 Tbsp or less on a per 50 g basis 
instead of a per RACC basis (Sec.  101.65(d)(3)(ii)(A) and (B)). This 
results in foods consumed in small amounts that are recommended for 
healthy dietary patterns qualifying for the claim.
     The rule expands the proposed exemption for raw, whole 
fruits and vegetables to provide that an individual food or mixed 
product that is comprised of one or more of the foods encouraged by the 
Dietary Guidelines, with no other added ingredients except for water, 
automatically qualifies for the ``healthy'' claim without meeting the 
specified criteria because of its nutrient profile and total 
contribution to an overall healthy diet. Such foods are vegetables; 
fruits; whole grains; fat-free and low-fat dairy; and lean meat, 
seafood, eggs, beans, peas, lentils, nuts, and seeds (Sec.  
101.65(d)(3)(i)).
     The rule makes several changes to the FGE criteria from 
what we proposed, including:
    [cir] The FGE for dairy is \2/3\ c-eq instead of \3/4\ c-eq.
    [cir] For combination foods (mixed products, main dishes, and 
meals), the rule provides additional flexibility in the proportions 
required for FGEs. For mixed products, the proposed rule would have 
required \1/2\ FGEs from each of the two food groups. The final rule 
requires that each food group component should have no less than \1/4\ 
FGE and that the combined amount of two or more different groups be 
equal to one total FGE (e.g., \1/4\ FGE from one food group and \3/4\ 
FGE from the second food group) (Sec.  101.65(d)(3)(iii)). For main 
dish products and meal products, the proposed rule would have required 
exactly 1 FGE each of two or three different food groups, respectively. 
The final rule requires that each food group component have no less 
than \1/2\ FGE to comprise the total of 2 FGEs for main dish products 
and 3 FGEs for meal products (Sec.  101.65(d)(3)(iv)-(v)). This 
increased flexibility for FGE requirements will result in more 
products, such as plant-based patties, being able to meet the FGE 
requirements for combination foods while still containing meaningful 
amounts of the different food groups.

[[Page 106072]]

    [cir] Vegetable and fruit powders that are produced by drying whole 
vegetables and fruits and grinding into powder form have similar 
nutrient content to whole vegetables and fruits, and they may be 
considered in calculation of the vegetable and fruit FGEs for the 
``healthy'' claim.
     The rule makes a number of changes to the nutrient to 
limit criteria from what we proposed, including:
    [cir] The rule provides more flexibility for sodium in mixed 
products by increasing the limit from <=10% DV to <=15% DV per RACC 
(Sec.  101.65(d)(3)(iii)).
    [cir] The rule provides more flexibility for added sugars in whole 
grain products by increasing the limit from <=5% DV to <=10% DV for the 
grains group (Sec.  101.65(d)(3)(ii)).
    [cir] The rule finalizes an added sugars limit for individual 
fruits, vegetables, and protein foods of <=2% of the DV in 
consideration of the addition of small amounts of added sugars through 
seasonings and recipes, as well as for the functional attributes of 
sugars (Sec.  101.65(d)(3)(ii)).
    [cir] The rule excludes the inherent saturated fat in seafood from 
the saturated fat limit for seafood products and lowers the saturated 
fat limit for seafood products to <=5% DV, to provide more flexibility 
for seafood, which has a fat profile that is predominantly beneficial 
unsaturated fats but has amounts of naturally occurring saturated fat 
that can vary across and within different types of seafood (Sec.  
101.65(d)(3)(ii)). This approach is consistent with the proposed 
approach for nut and seed products.
    [cir] For combination foods (mixed products, main dishes, and 
meals), the rule streamlines the NTL criteria so that there is one 
limit each for saturated fat, sodium, and added sugars for mixed 
products, for main dishes, and for meals (i.e., limits do not vary 
based on food groups within each category) (Sec.  101.65(d)(3)(iii)-
(v)).
     The rule expands the exemption for plain and plain, 
carbonated water to include all water, tea, and coffee with less than 5 
calories per RACC and per labeled serving (Sec.  101.65(d)(3)(vi)). The 
exemption includes carbonated or noncarbonated water, coffee, and tea, 
containing non-caloric ingredients such as flavors, no- or low-calorie 
sweeteners, vitamins, and minerals.

IV. Legal Authority

    We are issuing this 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 false or 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 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 help 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 (2) of 
the FD&C Act 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) and (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 or ``high in oat 
bran''). 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 to 
2375, January 6, 1993). That rulemaking resulted in regulations 
defining ``implied nutrient content claims'' as including 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 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). The preamble to the 1994 final rule 
explained 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 of HHS (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 established a 
definition for ``healthy'' when it is used in a nutritional context.
    This rulemaking updates the definition of ``healthy'' when used as 
an implied nutrient content claim, based on current nutrition science 
and Federal dietary guidance. The updates also reflect the science 
underlying the changes made to the Nutrition Facts label in the 2016 
update to that labeling requirement. As explained in section III. 
(``Background''), our updated criteria for ``healthy'' incorporate both 
food group and NTL requirements. These changes are intended to ensure 
that foods bearing the implied nutrient content claim ``healthy'' are 
nutrient-dense 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 revised definition of ``healthy'' is consistent with the 
framework

[[Page 106073]]

established by the statute and regulations as informed by current 
science. 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). FDA regulations define ``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. The statute's reference to characterizing the level 
of any nutrient and the regulation's reference to maintaining healthy 
dietary practices incorporate a scientific component because both the 
characterization and the assessment of healthy dietary practices 
involve an evaluation of the impact of diet on health. As science 
evolves over time, the understanding of how nutrient levels should be 
characterized and appropriate measures for maintaining healthy dietary 
practices may also evolve. Thus, it is appropriate and consistent with 
the regulatory framework for FDA to update definitions related to 
implied nutrient content claims based on current science.
    The term ``healthy'' can be an implied nutrient content claim 
because it suggests that the food, because of its nutrient content, may 
help consumers maintain healthy dietary practices. The 1994 definition 
of the claim discussed levels for nine different individual nutrients: 
fat, saturated fat, cholesterol, vitamin A, vitamin C, calcium, iron, 
protein, and fiber (Sec.  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). The 
Dietary Guidelines, 2020-2025 reflects the current scientific 
understanding that nutrients are not consumed in isolation and focuses 
its recommendations on consuming a variety of nutrient-dense foods, 
across all food groups, as part of a healthy dietary pattern. 
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 
eating a variety of nutrient-dense foods. Additionally, the Dietary 
Guidelines, 2020-2025 recommends increasing intakes of certain food 
groups and subgroups to shift intakes of underconsumed dietary 
components closer to recommendations.
    As we have long explained, the ``healthy'' claim thus 
``characterizes the level of [some] nutrient[s] in a food'' by 
implicitly stating that the food contains nutrients at levels or in 
combinations that help consumers maintain healthy dietary practices. 
Our 1994 definition sought to ensure that the use of that claim would 
help consumers who choose to maintain such dietary practices, would not 
be misleading, and would reduce consumer confusion. That definition did 
so by tying the use of the claim to circumstances in which the claim 
accorded with then-accepted scientific and medical understandings. As 
the underlying science has developed--in ways reflected in the Dietary 
Guidelines, 2020-2025--the definition of the claim must be updated to 
ensure that our regulation continues to serve its original functions.
    The final rule's definition of ``healthy'' includes food groups 
that provide a number of different nutrients. It thus reflects the 
conclusion that the use of the term ``implicitly'' characterizes 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 updated definition of the ``healthy'' claim represents the 
inclusion of multiple important nutrients. The use of food groups 
better accounts for how all these nutrients contribute, and may work 
synergistically, to create a healthy dietary pattern and improve health 
outcomes. It thus better accounts for how the use of the ``healthy'' 
claim implicitly characterizes the level of nutrients in a food--as 
containing nutrients in sufficient levels and combinations that 
contribute to healthy dietary patterns, which can lead to better health 
outcomes. By requiring products to contain a certain amount of a food 
group, the final 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.
    In addition to section 403(r)(2) of the FD&C Act, we are issuing 
this 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 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 finalize 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 applies only to foods voluntarily bearing the 
``healthy'' claim for which an adequate analytical method to determine 
FGE is not available or the amount cannot be discerned from the label 
alone. The records will 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 records 
requirements will help in the efficient enforcement of the FD&C Act 
(see discussion in section V.I (``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 Sec.  101.65(d)(4). Failure to make and 
keep records and provide the records to FDA, as described in 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.

[[Page 106074]]

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received approximately 400 comments on the proposed rule. We 
received comments from consumers; consumer groups; academia; trade 
organizations; industry (e.g., food manufacturers); public health 
organizations; public advocacy groups; Congress, State, and local 
government agencies; and other organizations. In the remainder of this 
section, we summarize these comments, respond to them, and explain any 
revisions we made to the proposed rule. Where we did not receive 
comments and do not have additional discussion in this final rule, we 
finalized the proposed provisions without change.
    We have numbered each comment to help distinguish between different 
comments. We have grouped similar comments together under the same 
number, and, in some cases, we have separated different issues 
discussed in the same comment and designated them as distinct comments 
for purposes of our responses. The number assigned to each comment or 
comment topic is purely for organizational purposes and does not 
signify the comment's value, importance, or the order in which comments 
were received.

B. General Comments

    Many comments make general remarks supporting or opposing the 
proposed rule without focusing on a particular proposed provision.
    (Comment 1) The majority of the comments express general support 
for updating the ``healthy'' implied nutrient content claim to make it 
consistent with current nutrition science and Federal dietary guidance, 
including the Dietary Guidelines, 2020-2025, noting the claim has not 
been updated since the 1990s. Numerous comments note that the proposed 
rule would help consumers make better, healthier choices for purchasing 
and consuming food, generally improve the nutritional knowledge of the 
average U.S. consumer, and give consumers information that could help 
combat the high rate of obesity and diet related chronic diseases and 
illnesses in the United States.
    (Response 1) We agree with the comments that support updating the 
``healthy'' implied nutrient content claim. Nutrition science has 
evolved since the 1990s when FDA first established a definition for the 
implied nutrient content claim ``healthy,'' and the purpose of this 
rule is to update the definition to be consistent with current 
nutrition science and Federal dietary guidance, such as the Dietary 
Guidelines, 2020-2025, to help ensure that consumers have access to 
more complete, accurate, and up-to-date information in the labeling of 
human food products. As more fully discussed in section III. 
(``Background''), the fundamental purpose of a ``healthy'' claim is to 
highlight those foods that, based on their nutrient levels, are 
particularly useful in constructing a diet that is consistent with 
current dietary guidelines. The current Dietary Guidelines, 2020-2025 
focuses on the importance of a healthy dietary pattern as a whole and 
its role in promoting health, reducing risk of chronic diseases, and 
meeting nutrient needs (Ref. 1). Therefore, foods that qualify for 
``healthy'' are those foods that are particularly useful in helping 
consumers with creating healthy dietary patterns. As discussed, with 
this framework, we emphasize that foods that do not qualify for use of 
the claim are not necessarily ``unhealthy'' or unable to provide any 
nutritional benefits to consumers. Foods that meet the requirements for 
the ``healthy'' claim are foods that, because of their overall 
nutrition profiles, can be a ``foundation'' for a healthy dietary 
pattern recommended by the Dietary Guidelines, 2020-2025. Foods that do 
not meet the requirements could, however, have attributes that are 
beneficial. As more fully discussed above in section III. 
(``Background''), these beneficial attributes can be communicated to 
consumers in other ways. We reiterate that an inability to meet the 
requirements for use of the claim ``healthy'' does not necessarily make 
a food unhealthy and that manufacturers can communicate the nutritional 
qualities of their foods through other applicable label claims and any 
truthful and non-misleading statements they want to include.
    (Comment 2) Some comments recommend the term ``healthy'' continue 
to evolve as science around nutrition changes and ask us to clarify our 
intentions to update the claim in the future, as needed.
    (Response 2) Although the Dietary Guidelines are published every 5 
years to reflect current nutrition science, and 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). As discussed 
in the proposed rule (87 FR 59168 at 59170), 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 includes recommendations to limit daily intake of added sugars, 
saturated fat, and sodium, and emphasizes ``shifts,'' or replacement of 
less healthy food choices with nutrient-dense foods, as methods for 
consumers to achieve a healthy dietary pattern. The scientific evidence 
discussed in the Dietary Guidelines, 2020-2025 and the Scientific 
Report of the 2020 Dietary Guidelines Advisory Committee (2020 DGAC 
report), and the recommendations based on that nutrition science, have 
informed this rulemaking and are the primary basis for the criteria 
that we have established for the ``healthy'' nutrient content claim. 
While there has been consistency in many of the recommendations in 
Federal dietary guidelines and the underlying nutrition science on 
which they are based, we intend to remain aligned with the most current 
nutrition science reflected in Federal dietary guidelines and will 
update our regulations and policies, as appropriate. However, we note 
that the updated definition of ``healthy'' is designed to be flexible 
and to accommodate possible changes in updated recommendations, as 
discussed further below in this section. For example, instead of tying 
the nutrient limits to absolute values, the criteria are provided as 
percentages of the DV.
    (Comment 3) Some comments ask FDA to clarify that our work to 
update the ``healthy'' definition does not signal that other foods do 
not have a role to play in a healthy dietary pattern or something 
broader, such as whether a food is ``good'' or ``bad'' or ``some other 
broader policy recommendation.'' Some comments assert that allowing 
some foods to be labeled as ``healthy'' could lead consumers to infer 
all other foods are unhealthy, even if such foods have beneficial 
components, which could limit options for low-income and vulnerable 
populations.
    Several comments assert that ``healthy'' diets vary across 
cultures, ages, and disease states and suggest that, for example, a 
healthy diet for an individual recovering from an eating

[[Page 106075]]

disorder is vastly different from a healthy diet for someone who has 
heart failure. The comments argue that allowing foods to be labeled as 
``healthy'' implies that foods without those labels are ``unhealthy'' 
and could exacerbate eating disorders and possibly trigger relapse or 
otherwise prevent recovery. Some comments claim that FDA is incorrectly 
indicating that ``healthy'' is the same for everyone and suggest that 
our focus should instead be on giving people the tools to evaluate the 
specific nutrients that are in food and that we should consider 
removing the ``healthy'' claim altogether and refocus labeling efforts 
on clear and concise labeling that is sensitive to multiple cultures, 
disease states, and ages.
    (Response 3) In this rule, we are updating the criteria for the 
``healthy'' nutrient content claim so that it aligns with current 
nutrition science and Federal dietary guidance. The fundamental purpose 
of a ``healthy'' claim is to highlight those foods that, based on their 
nutrient levels, are particularly useful in creating a diet that is 
consistent with current dietary guidelines. As discussed, with this 
framework, we emphasize that foods that do not qualify for use of the 
claim or do not use the claim are not necessarily ``unhealthy'' or 
unable to provide any nutritional benefits to consumers. Foods that 
meet the requirements for the ``healthy'' claim are foods that, because 
of their overall nutrition profiles, are useful as a foundation for a 
healthy dietary pattern recommended by the Dietary Guidelines, 2020-
2025. The scientific evidence that informs the Dietary Guidelines is 
representative of the U.S. population, including people who are 
healthy, people at risk for diet-related chronic conditions and 
diseases (e.g., CVD, type 2 diabetes, and obesity), and some people who 
are living with one or more of these diet-related chronic illnesses 
(Ref. 1). The Dietary Guidelines, 2020-2025 states that a ``fundamental 
premise of the 2020-2025 Dietary Guidelines is that nearly everyone, no 
matter their health status, can benefit from shifting food and beverage 
choices to better support healthy dietary patterns'' and explains that 
it is essential that medical organizations and health professionals 
adapt the Dietary Guidelines to meet the specific needs of their 
patients (Ref. 1). For consumers who would like to evaluate the 
specific nutrients that are in a food or beverage, the Nutrition Facts 
label is an available tool. The comments did not provide, and we are 
not aware of, evidence that a food labeled ``healthy'' for the narrow 
purpose of making a voluntary nutrient content claim could adversely 
impact those with eating disorders. We plan to undertake consumer 
education efforts related to the ``healthy'' claim, which we expect to 
include highlighting the importance of choosing a variety of nutrient-
dense foods within and across different food groups and subgroups.
    (Comment 4) Some comments argue that the proposed rule would not 
cause a ``significant'' change in consumer behavior or diet, warning 
that a ``healthy'' claim on processed and packaged products could 
discourage consumers from buying whole fruits and vegetables. However, 
such comments also note that an update to the ``healthy'' definition 
would make food products labeled with the claim align with current 
nutrition standards and lead to more healthy products being sold. The 
comments also assert that packaged food products are ``essential'' for 
communities that cannot afford exclusively fresh foods, and state that 
the new definition would help customers identify healthier options.
    (Response 4) Nutrient content claims such as ``healthy'' are 
intended to provide consumers with information to help them quickly and 
easily identify foods that can be the foundation of a healthy dietary 
pattern. We agree that the updated ``healthy'' claim, which focuses on 
food groups and NTL, will better align with current nutrition science 
and support consumers, including those who frequently purchase packaged 
foods, in identifying healthier options. We disagree that the updated 
healthy claim could discourage consumers from buying whole fruits and 
vegetables. Both processed and packaged foods as well as fresh, whole 
foods, such as fruits and vegetables will be able to qualify for the 
``healthy'' claim. Foods that qualify for the healthy claim that are 
not packaged can have the claim communicated to consumers through 
signage and other materials in the store. Therefore, through use of the 
``healthy'' claim, consumers will have additional information on foods 
throughout the grocery store that can help make more informed 
decisions.
    (Comment 5) Some comments oppose the proposed definition of 
``healthy,'' asserting that the term ``healthy'' is not easily 
definable, will be used inconsistently, can quickly become outdated, 
and is a subjective term that can be applied differently for different 
people. Some comments assert that this change would allow food 
manufacturers to incorrectly label what the comments consider unhealthy 
foods as ``healthy,'' thus allowing manufacturers to mislead and 
deceive consumers. Some comments oppose the rule by asserting that 
government control over food labeling and promulgation of rules about 
what can be called ``healthy'' is unnecessary.
    (Response 5) The rule establishes updated criteria for the narrow 
use of the term ``healthy'' as a voluntary nutrient content claim. As 
discussed in section IV. (``Legal Authority''), Congress passed the 
NLEA with three basic objectives: (1) to make available nutrition 
information that can help consumers select 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. 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 
(2) of the FD&C Act 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) and (r)(2)(A) of the FD&C 
Act). Hence, establishing a definition of ``healthy,'' when used as a 
nutrient content claim, is necessary for such claims to be lawfully 
made and is partially intended to serve the very purpose these general 
comments opposing the rule use to argue against it, namely, to avoid 
consumer confusion and misleading claims. 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. Further, under section 403(r)(1)(A) and (r)(2) 
of the FD&C Act, use of the ``healthy'' nutrient content claim would 
misbrand a food unless it is made in accordance with the regulatory 
definition we are establishing in this rule.

[[Page 106076]]

C. Food Group Equivalents

1. General Comments
    (Comment 6) Numerous comments support using food groups as criteria 
in the definition of the claim ``healthy,'' stating that the change 
from focusing on individual nutrients better reflects the Dietary 
Guidelines, ensures that more nutrient-dense foods are included in the 
``healthy'' definition, increases flexibility for certain products, 
avoids shifting nutrient guidelines, and is clearer to consumers. The 
comments mention that use of the food group criteria will enhance the 
messaging around the importance of creating healthy eating habits as 
opposed to a framework that targets individual foods. Some comments 
also provide that basing the ``healthy'' definition on food groups 
rather than individual nutrients is more consistent with evolving 
nutrition science that emphasizes dietary patterns. One comment 
mentions that requiring products to meet food-based criteria may help 
minimize or avoid unintended consequences of a focus solely on 
individual nutrients.
    Some comments oppose use of food groups as criteria in the 
definition of the claim ``healthy,'' as opposed to individual 
nutrients, claiming the FGEs are too complex and difficult to 
calculate, that there is too much variance in nutrients within certain 
food groups, and the healthfulness of foods should be based on 
different individual nutrients. One comment claims that FDA has not 
adequately justified the move from only considering nutrients to also 
including food groups in the definition of the ``healthy'' claim.
    (Response 6) We agree that the food group approach is in alignment 
with the Dietary Guidelines, 2020-2025, which places an emphasis on a 
healthy dietary pattern as a whole, rather than on individual nutrients 
or foods in isolation. 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. The Dietary Guidelines, 2020-2025 
provides that a healthy dietary pattern consists of nutrient-dense 
forms of foods and beverages, in recommended amounts, across all food 
groups and recommends increasing intakes of certain food groups and 
subgroups to move intakes of underconsumed dietary components closer to 
recommendations.
    We disagree that the FGE approach is too complex and note that 
there are several currently available resources that can help with 
calculation. As discussed further herein, the food groups and the FGE 
amounts are based on information contained in the Dietary Guidelines, 
2020-2025; as such, the Dietary Guidelines, 2020-2025 is a helpful 
resource in determining the amounts of foods necessary to meet FGEs. 
The USDA Food Patterns Equivalents Database (FPED) also provides 
information about cup- and ounce-equivalents of different foods and 
beverages to assist with calculations (Ref. 3). Additionally, FDA 
recognizes the importance of time for industry to determine the FGE 
amounts in their products, and we have set the rule's compliance date 
as being 3 years from the rule's effective date. We intend to provide 
additional resources for manufacturers to help determine FGE amounts 
before the compliance date. The additional resources may include 
guidance documents for industry, information on the FDA website, FAQs, 
direct communications in response to questions, or online webinars.
    (Comment 7) Many comments support using food groups as criteria in 
the definition of the claim ``healthy,'' but ask that the rule maintain 
a level of reliance on individual beneficial nutrients or include 
requirements for beneficial nutrients as an alternative to ensure that 
important nutrients are not missed by the rule focusing too heavily on 
food groups. Some comments support the food group approach, but request 
that the updated ``healthy'' criteria permit a food to qualify if it 
meets both the NTL and either the food groups to encourage or the 
original NTE criteria.
    (Response 7) We discussed in section III. (``Background'') that the 
purpose of a ``healthy'' claim is to highlight those foods that, based 
on their nutrient levels, are particularly useful in creating a diet 
that is consistent with current dietary guidelines. The current Dietary 
Guidelines, 2020-2025 (Ref. 1) focuses on the importance of a healthy 
dietary pattern as a whole and its role in promoting health, reducing 
risk of chronic diseases, and meeting nutrient needs. Therefore, based 
on current dietary recommendations and nutrition science, foods that 
qualify for ``healthy'' are those foods that are particularly useful in 
helping consumers create healthy dietary patterns. As described by the 
Dietary Guidelines, 2020-2025, a healthy dietary pattern ``consists of 
nutrient-dense forms of foods and beverages across all food groups, in 
recommended amounts, and within calorie limits.'' The Dietary 
Guidelines, 2020-2025 also describes that ``[c]ommon 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 original definition for the ``healthy'' 
nutrient content claim was based solely on individual nutrients, both 
minimum amounts and specific limits. This approach is inconsistent with 
current nutrition science regarding healthy dietary patterns and their 
effect on health and development of chronic disease. Foods that contain 
certain NTE, such as certain individual vitamins, minerals, or fiber, 
can be beneficial to consumers. However, highlighting those foods as 
``healthy'' would not necessarily help consumers in the overall 
construction of healthy dietary patterns, in which nutrient-dense foods 
from across all of the recommended food groups and subgroups provide an 
array of nutrients and ensure overall nutrient adequacy from the diet. 
Including requirements for minimum amounts of foods from the 
recommended food groups better reflects the overall nutrient content of 
foods and how nutrients in the food groups and subgroups may work 
together as part of a healthy dietary pattern. Thus, we decline to 
include individual NTE criteria in the final rule.
    (Comment 8) Some comments assert that FDA's proposed FGE is 
sometimes larger than the serving size of the product itself, 
particularly for products with small serving sizes that would be unable 
to qualify as ``healthy'' because they could not provide an FGE per 
RACC. Examples of types of foods discussed in the comments include 
certain whole grain bread products, certain snack foods, natural 
cheeses, and many yogurts. The comments state that these smaller RACC 
products would be excluded from making ``healthy'' claims solely based 
on their serving size. The comments request that FDA modify the 
criteria for products with small RACCs to require a smaller 
contribution to the FGEs. The comments suggest various different 
modifications to the criteria, including lowering the required FGE 
amounts, adjusting the criteria for the claim to incrementally increase 
based on food size, and adopting a category with criteria for foods 
with small RACCs.
    (Response 8) In the proposed rule (87 FR 59168 at 59177), we 
determined the FGEs based on the cup- and ounce-equivalents and 
recommended daily food group amounts developed for the

[[Page 106077]]

Healthy U.S.-Style Dietary Pattern for ages 2 and older in the Dietary 
Guidelines, 2020-2025 (Ref. 1). The proposed thresholds for the FGEs 
were set so that foods that bear the claim ``healthy'' contain enough 
of the food group that they could help consumers achieve the 
recommended daily food group amounts. Foods that do not contain the 
minimum FGE amount for their food group would not meet the requirements 
and not be eligible to bear the claim. As many comments point out, 
however, there are many foods that are included in the food groups 
recommended by the Dietary Guidelines, and fit into healthful dietary 
patterns, that are in forms whose RACCs are smaller than the minimum 
FGE requirement. After evaluating nutrient-dense foods with small RACCs 
across the recommended food groups and subgroups, we have determined 
that many of these foods with RACCs smaller than the proposed FGEs 
could qualify for use of the claim ``healthy'' if their RACC sizes were 
similar to those of typical individual foods and if they met all the 
other requirements for the use of the claim (Ref. 2).
    FDA has previously addressed challenges related to foods with small 
RACCs in its nutrition labeling regulations. For example, in the 
context of eligibility for ``low'' nutrient content claims, FDA 
provided different criteria for eligibility to use the ``low fat'' 
claim based on the RACC of the individual food (Sec.  101.62(b)(2)). In 
the context of the low-fat claim, FDA applies different criteria based 
on RACC size to ensure that a food does not qualify for a ``low fat'' 
claim solely because it is consumed in small amounts.
    For the proposed ``healthy'' definition, the reverse situation is 
present in that certain foods recommended for healthful dietary 
patterns would be unable to meet the FGE criteria for the claim due to 
being typically consumed in small amounts. Because we do not intend to 
exclude foods consumed in small amounts that are recommended for 
healthful dietary patterns, the final rule applies the ``healthy'' 
criteria to individual foods with a RACC of 50 g or less or 3 Tbsp or 
less on a per 50 g basis instead of a per RACC basis (Sec.  
101.65(d)(3)(ii)(B)).
    In the context of the ``low fat'' claim, FDA defined small RACC 
foods as ``individual foods that have a RACC of 30 g or less or 2 Tbsp 
or less.'' For the purposes of the ``healthy'' claim, to most 
appropriately include the variety of foods recommended by the Dietary 
Guidelines for healthful dietary patterns, which was supported by our 
review of food products in the current marketplace (Ref. 2), we are 
defining small RACC foods as foods with a RACC of 50 g or less or 3 
Tbsp or less.
    This change to the criteria for small RACC foods acknowledges that 
there have been a number of changes to individual RACC sizes since 
nutrient content claim criteria for foods with small RACC sizes, such 
as for the ``low fat'' claim (Sec.  101.62(b)(2)), were implemented. As 
an example, medium weight cereals initially had a RACC size of 30 g, 
which would fall under the small RACC description included in other 
nutrient content claims such as the ``low fat'' claim. In 2016, FDA 
updated the RACC size for medium weight cereals to 40 g (Sec.  
101.12(b)). Thus, medium weight whole grain cereals are no longer 
considered a food with small RACC under the nutrient content claim of 
``low fat.'' If we were to define small RACCs as ``individual foods 
that have a RACC of 30 g or less or 2 Tbsp or less'' for purposes of 
the ``healthy'' claim, medium weight whole grain cereals would not be 
considered to have a small RACC size, would have the ``healthy'' 
criteria applied on a per RACC basis (40 g), and would not meet the 
whole grain FGEs. However, medium weight nutrient-dense whole grain 
cereals, which are recommended as part of a healthy dietary pattern, 
will meet the whole grain FGE criterion for the ``healthy'' claim on a 
50 g basis. As demonstrated when we reviewed the current marketplace 
(Ref. 2) in our data analysis, whole grain cereals are just one of many 
nutrient-dense foods recommended as part of a healthy dietary pattern 
that would not meet the FGE criteria on a 30 g basis but would meet 
them on a 50 g basis. Therefore, to ensure that nutrient-dense foods 
that are recommended for healthful dietary patterns are able to qualify 
for the ``healthy'' claim, the final rule applies the ``healthy'' 
criteria to individual foods with a RACC of 50 g or less or 3 Tbsp or 
less on a per 50 g basis instead of a per RACC basis (Sec.  
101.65(d)(3)(ii)(B).
    We have also made other changes that will result in more nutrient-
dense foods with serving sizes that are smaller than the proposed FGE 
requirements being able to qualify for the ``healthy'' claim. For 
example, we have expanded the proposed exemption for raw, whole fruits 
and vegetables (see Response 9) and lowered the FGE requirement for 
dairy (see Response 29). We did not receive comments that the proposed 
FGE requirements were too restrictive for other food groups and 
subgroups, aside from concerns regarding products with small RACC sizes 
and the dairy FGE requirement. Therefore, we are finalizing the FGE 
requirements as proposed for the other food groups and subgroups.
    (Comment 9) Many comments support the exemption in the proposed 
rule that would allow any raw, whole fruits and vegetables, including 
any whose RACC size might be smaller than the fruit and vegetable FGE 
requirements, to qualify for the ``healthy'' claim. Some comments note, 
however, that other fruit and vegetable options, such as frozen fruits 
and vegetables or chopped fruits and vegetables (without added 
ingredients), would not meet the proposed automatic qualification for 
raw, whole fruits and vegetables. Some comments mention that, while 
fresh or raw avocados would qualify under the exemption as proposed, 
frozen avocados would not. The comments request that the exemption for 
raw, whole fruits and vegetables be expanded to include other forms, 
such as frozen and chopped fruits and vegetables.
    Some comments note that other food groups recommended by the 
Dietary Guidelines also include many similar, single-ingredient foods 
that align with recommendations in the guidelines but would not qualify 
for the ``healthy'' claim under the proposed rule. The comments assert 
that the FGE and NTL criteria are not necessary for these types of 
products because they are nutrient-dense foods encouraged by the 
Dietary Guidelines. The comments request that we expand the exemption 
for raw, whole fruits and vegetables to other single-ingredient 
nutrient-dense foods recommended by the Dietary Guidelines or include 
an additional category for nutrient-dense whole foods recommended by 
the Dietary Guidelines to ensure that these types of foods can also 
qualify for the ``healthy'' claim without needing to meet the FGE and 
NTL criteria.
    (Response 9) We do not intend to exclude nutrient-dense single-
ingredient foods that are foods encouraged by the Dietary Guidelines 
from qualifying for the updated ``healthy'' definition. We agree that 
it is not necessary for such foods to meet additional criteria because 
they are nutrient-dense foods encouraged by the Dietary Guidelines that 
can help consumers maintain healthy dietary practices by serving as a 
foundation for a healthy dietary pattern. Therefore, we have revised 
the rule to expand the exemption for raw, whole fruits and vegetables 
to include individual foods or mixed products that are comprised of one 
or more of the following nutrient-dense foods encouraged by the Dietary 
Guidelines (for adults and children 2 years of age and older), with no 
other added

[[Page 106078]]

ingredients except for water: vegetables; fruits; whole grains; fat-
free and low-fat dairy; and lean game meat, seafood, eggs, beans, peas, 
lentils, nuts, and seeds (Sec.  101.65(d)(3)(i)). Individual foods and 
mixed products that contain these nutrient-dense foods encouraged by 
the Dietary Guidelines and do not contain any added ingredients, 
besides water, will automatically qualify for the ``healthy'' claim 
because of their nutrient profile and positive contribution to an 
overall healthy diet. Such products do not need to meet the FGE and NTL 
requirements for individual foods or mixed foods. For example, foods 
such as fish and lean game meats, skim milk, brown rice, and the many 
other single-ingredient nutrient-dense foods encouraged by the Dietary 
Guidelines can use the ``healthy'' nutrient content claim without 
having to meet the FGE and NTL requirements.
    For similar reasons to those discussed above, we are also expanding 
the exemption so that it will not be limited to ``raw, whole'' versions 
of foods encouraged by the Dietary Guidelines, but rather will include 
other forms of these foods, including a variety of shelf-stable and/or 
economical forms of foods. For example, frozen or sliced fruits and 
vegetables, 100% whole grain flours, dried beans, peas, and lentils, 
frozen seafood, chopped nuts, and certain nut butters (i.e., only 
containing nuts), with no added ingredients other than water, 
automatically qualify without needing to meet the FGE and nutrient to 
limit requirements. Additionally, as a result of the expansion of this 
exemption, single-ingredient foods encouraged by the Dietary Guidelines 
that have small RACC sizes (e.g., frozen avocado pieces) will now 
qualify even if their RACCs are smaller than the FGE amounts for their 
respective food groups or subgroups.
    Certain mixed products are also eligible for the exemption. A mixed 
product that contains multiple single-ingredient foods encouraged by 
the Dietary Guidelines (without additional ingredients besides water) 
but does not meet the FGE requirements for a mixed product to qualify 
for ``healthy'' (i.e., contain 1 total FGE) will fall under the 
expanded exemption and will automatically qualify for the claim (Sec.  
101.65(d)(3)(i)). We have determined that these types of products 
(i.e., mixed products that contain only nutrient-dense foods that are 
encouraged by the Dietary Guidelines without added ingredients besides 
water) can also serve as part of a foundation for a healthy dietary 
pattern because of their nutrient profile and positive contribution to 
an overall healthy diet. Many of these types of products, regardless of 
whether they are individual foods or mixed products, would also meet 
the FGE and NTL criteria for individual foods or mixed products; 
however, this exemption allows manufacturers to more easily determine 
and verify compliance with the updated ``healthy'' criteria, 
particularly for mixed products. For example, a product that contains 
two ingredients that are each a food encouraged by the Dietary 
Guidelines--such as a frozen mix of a vegetable and a whole grain, or a 
blend of 100% juices that contains 80% fruit juice and 20% vegetable 
juice--and does not contain additional ingredients besides water, will 
automatically qualify under the expanded exemption in Sec.  
101.65(d)(3)(i). We are finalizing the expanded exemption under Sec.  
101.65(d)(3)(i) as: an individual food or mixed product that is 
comprised of one or more of the following foods that are the foundation 
of a healthy dietary pattern, with no other added ingredients except 
for water: (1) vegetable; (2) fruit; (3) whole grains; (4) fat-free and 
low-fat dairy; and (5) lean meat, seafood, eggs, beans, peas, lentils, 
nuts, and seeds. Additionally, because the standard information 
required on the food label, such as the list of ingredients for such a 
product, provides sufficient information to verify that the food meets 
the ``healthy'' criteria, records will not be required to demonstrate 
compliance with the FGE requirements for products that qualify for the 
automatic exemption in Sec.  101.65(d)(3)(i) and (d)(4).
    We are not expanding the exemption to main dishes or meals because 
those products serve different roles in the diet. Main dish products, 
defined by our regulations 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 
(i.e., contain most of the components of 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 the larger contribution that they make to the overall diet, we 
are requiring in Sec.  101.65(d)(iv) that main dish products contain at 
least two total FGEs per labeled serving with a minimum of a \1/2\ FGE 
for each of the two food groups, and that they meet NTL criteria (see 
Section V.E ``Combination Foods'' for further discussion of 
requirements for mixed products, main dishes, and meals). 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 provide all food for a single eating occasion (i.e., a 
complete meal). An example of a meal is a frozen dinner that includes 
an entr[eacute]e, vegetable side, and dessert. Because of their size 
and the larger contribution that they make to the overall diet, we are 
requiring in Sec.  101.65(d)(v) that meal products contain at least 
three total FGEs per labeled serving with a minimum of a \1/2\ FGE for 
each of the three food groups. It is important that main dishes and 
meals contain a minimum amount of different food groups (i.e., meet the 
FGE criteria) because their size and larger contribution in the diet 
means that it is particularly important for them to contain an array of 
nutrients and to help consumers achieve the recommended daily food 
group amounts and meet nutritional needs, and therefore we are not 
including main dishes and meals in the expanded exemption.
    For simplicity, throughout the rule we will refer to this exemption 
as the ``single-ingredient exemption'' and will generally refer to 
these nutrient-dense foods that are encouraged by the Dietary 
Guidelines with no added ingredients, except for water, as ``single-
ingredient foods encouraged by the Dietary Guidelines.'' We again note, 
however, that these single-ingredient foods encouraged by the Dietary 
Guidelines and the single-ingredient exemption, also include individual 
foods and mixed products that contain multiple single-ingredient foods 
with no added ingredients, except for water (e.g., a frozen mix of a 
vegetable and a whole grain, or a blend of 100% juices that contains 
80% fruit juice and 20% vegetable juice).
    (Comment 10) Some comments also recommend that herbs and spices be 
able to qualify for the ``healthy'' claim. These comments assert that 
herbs and spices can reduce consumption of added sugars, sodium, and 
saturated fat by making nutrient-dense foods more palatable without 
adding calories. Additionally, the comments state that herbs and spices 
increase the consumption of nutrient-dense foods such as vegetables, 
fruits, and healthy grains. Some comments assert that spices meet the 
definition of vegetable products, but provide that given their small 
RACC, spices would not be able to meet the proposed FGE criteria.
    (Response 10) We agree that herbs and spices can play an important 
role in the diet by replacing seasonings and ingredients that 
contribute sodium, saturated fat, and added sugars to the diet. They 
can also help increase the palatability of nutrient-dense foods. 
However, because of their primary use

[[Page 106079]]

as a flavoring for foods, they are typically consumed in such small 
quantities that they generally do not contribute a meaningful amount of 
nutrients to the diet. The Dietary Guidelines, 2020-2025 mentions that 
spices and herbs can help flavor foods when reducing added sugars, 
saturated fat, and sodium, and that they can also contribute to the 
enjoyment of nutrient-dense foods (Ref. 1). Some herbs are included as 
examples in the vegetable food group in the Dietary Guidelines, 2020-
2025 (e.g., cilantro, basil, and chives). Foods or ingredients that are 
considered to be part of the vegetable food group can also contribute 
toward the FGE requirement for vegetables in different forms, such as 
dried forms (see Response 44).
    (Comment 11) Some comments suggest that FDA allow foods with small 
RACCs to satisfy their FGE requirement by having a component from a 
recommended food group as the first ingredient on the ingredient 
declaration. The comments suggest this ``first ingredient'' approach 
both for foods with small RACCs and as an alternative to the FGE 
requirement, not limited to foods with small RACCs. In the ``first 
ingredient'' approach, there would be no absolute amount of a food 
group required; the approach would require only that the component from 
a qualifying food group would be the ingredient of the greatest weight 
in a food.
    (Response 11) We decline to adopt the ``first ingredient'' approach 
suggested by the comments. The regulations regarding ingredient 
declaration require only that ingredients be listed in descending order 
of predominance by weight (21 CFR 101.4(a)). A descending order by 
weight does not, however, provide any indication of a significant or 
meaningful amount of an ingredient. Being listed first in the 
ingredient declaration only indicates that a food has proportionally 
more of that ingredient compared to each of the other ingredients 
individually. For example, a food could contain 10 different 
ingredients, and, although the first ingredient may weigh more than 
each of the other nine ingredients individually, the total sum of the 
other nine ingredients could proportionally outweigh the first 
ingredient. The overall food in that case would not be likely to have a 
significant amount of the first ingredient from a recommended food 
group and therefore would not meaningfully contribute to the 
recommended daily food group amounts. Therefore, using the first 
ingredient in an ingredient list to determine FGEs would not be a 
reliable way to help consumers identify foods that can help them meet 
recommended food group amounts, nor would it effectively address 
challenges related to the qualification of foods with small RACCs. As 
discussed in Response 8, the rule includes criteria specific to small 
RACC foods.
    (Comment 12) Many comments request that FDA provide more guidance 
on what counts as an FGE and how to calculate the FGE contribution of a 
food. The comments note that the proposed FGE amounts are in volume, 
and that the volume of a food will vary considerably based on the form 
of the food. Some comments ask that FDA provide a standard methodology, 
calculator, and/or database that manufacturers could use to determine 
FGEs for their products.
    (Response 12) We determined FGE amounts based on the cup- and 
ounce-equivalents developed for the Healthy U.S.-Style Dietary Pattern 
for ages 2 and older in the Dietary Guidelines, 2020-2025 (Ref. 1). The 
Dietary Guidelines, 2020-2025 provides information on the many types of 
foods that are contained in each food group in the food patterns (see 
Ref. 1, Appendix A3-2, footnote b) and descriptions of how much of 
those foods are needed to meet a cup- or ounce-equivalent (see Ref. 1, 
Appendix A3-2, footnote c). Additionally, there are other resources 
available, such as the FPED, which provides further information about 
cup- and ounce-equivalents of different foods and beverages (Ref. 3). 
FDA understands that, depending on the type and form of an individual 
food, manufacturers may benefit from additional information on how to 
determine the amount necessary to meet the FGE amounts required for 
their foods to be eligible for the ``healthy'' claim. The final rule 
sets a compliance date that is 3 years from the effective date, and we 
intend to provide additional resources to help manufacturers comply 
with the final rule before the end of the compliance period. The 
additional resources may take the form of guidance documents for 
industry, information on the FDA website, FAQs, direct communications 
in response to questions, or online webinars, as discussed in Response 
6.
    (Comment 13) Many comments request that FDA make clear that the 
list we provided for FGEs in the preamble to the proposed rule is not 
exhaustive.
    (Response 13) The marketplace for food products is wide in scope 
and continually evolving and therefore cannot be comprehensively 
covered by the examples of FGEs described in this rule. Thus, the list 
of examples of FGEs we provided in the proposed rule and in the final 
rule is not an exhaustive list.
2. FGEs Based on Four Eating Occasions Per Day
    (Comment 14) Some comments express concern with the assumption in 
the proposed rule that the typical American dietary pattern consists of 
three meals and one snack per day (i.e., four eating occasions). The 
comments assert that the dietary habits of Americans have shifted over 
the past several years from a primarily meal-based diet to one that 
includes more snacking or ``ready to eat'' meals. The comments suggest 
that FGEs should not be based on a consumption pattern of four eating 
occasions per day. Another comment notes that the recommendations in 
the Dietary Guidelines, 2020-2025 were based on the assumption that 
Americans consume three meals per day and two snacks.
    Some comments question the equal division among the four eating 
occasions. For example, some comments suggest that snacks should be 
weighed differently than meals due to size. One comment recommends that 
meals carry three times the ounce equivalent (oz-eq) as a snack for the 
nutrient recommended daily allowance.
    (Response 14) Our review of consumption patterns indicates that the 
typical American dietary pattern consists of three meals and one snack 
per day, i.e., four eating occasions (not including beverage-only 
eating occasions) (Ref. 2). These data signify that individuals 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. The food group amounts recommended by the 
Dietary Guidelines, 2020-2025 (e.g., 2 c-eq/day of fruit) are total 
recommended amounts for the day, not for individual foods, meals, or 
snacks. The recommended daily amounts of food groups provided by the 
Dietary Guidelines, 2020-2025 are not dependent on number of eating 
occasions. In determining the food group requirements for ``healthy,'' 
the total daily amount of food groups are divided across the number of 
eating occasions as determined by the data from national consumption 
surveys. National consumption data over the last several decades, 
(i.e., the USDA Continuing Survey of Food Intakes by Individuals 1989-
91 and Diet and Health Knowledge Survey 1989-91 (CSFII/DHKS 1989-1991) 
through the 2015-2016 National Health and Nutrition Examination Survey

[[Page 106080]]

(NHANES)) (Refs. 2, 36, and 37) demonstrate that the highest percentage 
of the U.S. population ages 4 and older reported four eating occasions 
per day. Note that we excluded beverage-only eating occasions from our 
analysis of the 2015-2016 NHANES data to focus only on eating occasions 
that provided consumers with a meaningful opportunity to consume foods 
from all the recommended food groups.
    While some comments question the equal division among the four 
eating occasions, we decline to change this method for the final rule. 
For this rule, we analyzed the most current national consumption data, 
the 2017-March 2020 NHANES (Refs. 2 and 38), and determined that the 
median number of eating occasions (meals plus snacks) per day continues 
to be four eating occasions (not including beverage-only eating 
occasions) (Refs. 2 and 38). The data from NHANES 2017-2020 describe 
both the number of meals eaten per day and the number of snacks eaten 
per day. The data demonstrate that the highest percentage of people 
reported eating three meals per day. The highest percentage of people 
also reported eating one snack per day. Analysis of the combined eating 
occasion data show that the highest percentage of people reported 
having four eating occasions per day (meals plus snacks). We note that 
a study cited in the comments examined the same NHANES data that we 
used in our analysis. However, the study considered reports of 
beverage-only occasions whereas we excluded beverage-only occasions. 
Therefore, total number of eating occasions are different.
    The typical sizes of meals and snacks may differ but are not 
weighted differently when dividing the recommended daily food group 
amounts to determine the FGE amounts. This is because the meals and the 
snack are all eating occasions that provide consumers with an equal 
opportunity to consume foods from the recommended food groups. For 
example, the recommended daily amount for fruit is 2 cups per day, and 
consumers have the opportunity to consume fruit at all three meals and 
at a snack. Therefore, it is reasonable to divide the recommended daily 
amount for fruit among the four eating occasions equally, which results 
in an FGE amount of \1/2\ c-eq of fruit (2 c-eq divided by four eating 
occasions). We further note that this method is consistent with FDA's 
method in previous labeling rulemakings and relies on the same 
rationale (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 2379-2380).
3. FGEs for Vegetables
    (Comment 15) Some comments request that FDA provide more guidance 
on how to convert various forms of fruit and vegetable groups into a 
\1/2\ c-eq vegetables per RACC that we proposed as the FGE amount for 
vegetables, taking into consideration the changes in density that occur 
from processing steps such as chopping, pureeing, grating, and cooking. 
The comments also ask that FDA provide guidance on how to convert dried 
fruits and vegetables, including those in powdered forms, into the 
whole equivalent ``single strength'' form for purposes of determining 
the food group contribution.
    (Response 15) We are aware that the examples of FGEs described in 
the proposed rule did not represent all possible forms of foods, 
including different forms of vegetable products, such as chopped, 
dried, or grated vegetables. However, as noted in the proposed rule, 
the FGEs are based on the cup- and ounce-equivalents developed for the 
Dietary Guidelines, 2020-2025 (Ref. 1). The Dietary Guidelines, 2020-
2025 and the FPED (Ref. 3), which is used to develop the Healthy 
Dietary Patterns for the guidelines, provide detailed information about 
cup- and ounce-equivalents of different foods and beverages and are 
resources that can help manufacturers determine the appropriate FGE 
amounts. For example, the FPED describes that sliced, diced, or chopped 
raw vegetables are given the same cup weight and the cup weights are 
typically the average weights of different cuts. The FPED provides the 
example of raw carrots which are assigned a 125-gram cup weight, which 
is an average of one cup of sliced (122 g) and chopped (128 g) carrots 
(Ref. 3). We note that, as explained in Response 44, vegetable powders 
may be considered in the calculation of vegetable FGEs, which 
represents a change from the proposed rule.
    (Comment 16) Some comments support FDA's approach to include FGEs 
in the proposed ``healthy'' criteria on the basis that it would 
encourage increased consumption of fruits and vegetables but assert 
that the proposed approach to FGEs may limit products that can meet the 
requirements because they do not provide the required amount of FGEs. 
The comments assert that FDA should allow products to count ``partial 
FGEs,'' which could allow additional products to meet the FGE 
requirement for vegetables.
    (Response 16) As explained in Response 8, we do not intend to 
exclude foods consumed in small amounts that are recommended for 
healthful dietary patterns, including various vegetable products. Thus, 
we revised the rule at Sec.  101.65(d)(3)(ii)(B) to provide methods for 
addressing the qualification of foods with small RACCs. We also revised 
the rule, at Sec.  101.65(d)(i), to include a single-ingredient 
exemption, which expands the exemption for raw, whole fruits and 
vegetables to other nutrient-dense forms of fruits and vegetables (as 
well as to foods in other food groups). The expanded exemption will 
result in more fruit and vegetable products (i.e., single-ingredient 
fruits and vegetables without added ingredients besides water) 
qualifying for ``healthy,'' regardless of their RACC size (e.g., 
chopped or frozen fruits and vegetables). This single-ingredient 
exemption is discussed in Response 9.
    (Comment 17) Some comments urge FDA to consolidate the food groups 
for fruits and vegetables. The comments assert that combining the fruit 
and vegetable food groups would avoid ``arbitrary distinctions'' for 
products that contain a mixture of fruits and vegetables, and that a 
product that contains meaningful amounts of fruits, vegetables, or 
fruits and vegetables together should be treated the same, regardless 
of the precise contribution to the fruit group versus the vegetable 
group. One comment requests that FDA combine the fruit and vegetable 
groups for children ages 1-3 to provide flexibility for foods that 
contain meaningful amounts of fruits and vegetables collectively.
    (Response 17) We decline to combine the fruit and vegetable food 
groups in this final rule. Fruits and vegetables are considered 
different food groups in the Dietary Guidelines and have separate daily 
recommended intake amounts. As noted on the MyPlate website (https://www.myplate.gov/), while botanically, most vegetables are considered 
fruits, the two groups are separated for nutritional and culinary 
purposes, meaning distinctions are made based on nutrient content, use 
in meals, and taste (e.g., fruits are generally considered sweet or 
tart, while vegetables are not). Each food group provides a particular 
array of nutrients, and the recommended intake amounts of the different 
food groups reflect dietary patterns that are associated with positive 
health outcomes (Ref. 1). Healthy dietary patterns include intakes of 
foods from across the different food groups recommended by the Dietary 
Guidelines, including the fruit and vegetable food groups. Thus, 
vegetables

[[Page 106081]]

and fruits are distinct food groups that contribute their own nutrients 
and have separate recommended amounts for healthy dietary patterns. 
This distinction is applicable to foods directed at all ages, including 
foods intended for consumption by children over 2 years of age. As 
discussed in the Dietary Guidelines, individuals in all life stages are 
encouraged to consume foods from across all food groups to meet 
nutrient intake needs. Finally, the comments suggesting combining the 
vegetable and fruit group FGEs did not provide information on the 
benefits of combining the two food groups nor the effects such an 
action would have on the ability to construct healthy dietary patterns, 
and thus we have no basis on which to make such a change.
    Considering the conventional distinction between fruits and 
vegetables in diets and food preparation purposes, the differences in 
nutrient contributions from the two food groups, and consistency with 
the Dietary Guidelines, we do not agree that the vegetable and fruit 
food groups should be combined. The rule, therefore, retains the 
framework of the vegetable food group and fruit food group as two 
distinct food groups. However, we have modified the criteria in other 
ways to provide additional flexibility for mixed products, for example, 
with the expanded single-ingredient exemption for nutrient-dense foods 
encouraged by the Dietary Guidelines (see Response 9, Sec.  
101.65(d)(3)(i)), and for mixed products, main dishes, and meals, for 
example, through added flexibility in the proportions required for FGE 
requirements (see Response 106, Sec.  101.65(d)(3)(iii)-(v)). These 
modifications should help address the comments' concerns relating to 
the requirements for mixed products containing a mix of fruits and 
vegetables. For example, mixed products, such as a frozen mix of fruit 
and vegetables or a blend of 100% juices that contains 80% fruit juice 
and 20% vegetable juice, that do not contain additional ingredients 
besides water, will automatically qualify to bear the claim under the 
expanded single-ingredient exemption.
4. FGEs for Fruits
    (Comment 18) Some comments request that FDA provide more guidance 
on how to convert various forms of fruit and vegetable groups into a 
\1/2\ cup, taking into consideration the changes in density that occur 
from processing steps such as chopping, pureeing, grating, and cooking. 
One comment notes that moisture and solid levels vary among fruits and 
vegetables, and the conversion of 1 cup fresh or cooked fruits or 
vegetables to \1/2\ cup dried fruits and vegetables may not accurately 
reflect all types of fruits and vegetables. The comment requests that 
FDA allow food companies flexibility to use reasonable options for 
determining FGEs of their products when converting between dried and 
rehydrated forms of fruits and vegetables.
    (Response 18) We recognize that additional information on FGEs may 
be helpful and we respond to the comments requesting options for 
determining FGEs for different forms of fruit products, such as dried 
and rehydrated fruits (with regard to both vegetables and fruits) above 
in section V.C.3 (``FGEs for Vegetables''). We also provide information 
about available resources to support the determination of FGE amounts 
in Response 6 and 12.
    (Comment 19) A number of comments do not support a ``healthy'' 
claim being on 100% fruit juice. One comment provides that, although 
100% fruit juice in small amounts may offer a way for people to obtain 
important nutrients and contribute to dietary recommendations for fruit 
intake, 100% fruit juice is likely to be overconsumed because of its 
high palatability and accessibility. The comment says that the presence 
of a ``healthy'' claim may promote excess consumption of 100% fruit 
juice, which could contribute large amounts of unnecessary calories and 
sugar to the diet. Some comments note that the Dietary Guidelines, 
2020-2025 provides that whole fruit is the preferred way to meet the 
recommended fruit intake amounts.
    (Response 19) We disagree that 100% juice should not be able to 
qualify to bear the ``healthy'' claim. The Dietary Guidelines, 2020-
2025 states that foods in the fruit food group include both whole 
fruits and 100% juice, and the Healthy U.S.-Style Dietary Pattern for 
ages 2 and older includes 100% juice as a food that contributes to the 
healthy dietary pattern. As discussed in the 2020 DGAC report, 100% 
juice is a nutrient-dense food that does not contribute energy through 
added sugars and contributes to meeting nutrient and food group needs 
(Ref. 8). The comments suggesting that 100% fruit juices being labeled 
as ``healthy'' may promote excess consumption do not provide evidence 
that would contradict or cause us to question the Dietary Guidelines, 
2020-2025. As discussed elsewhere, the purpose of this rule is to help 
consumers identify foods that are particularly useful in creating a 
diet that is consistent with dietary recommendations. Based on the 
contributions of 100% juice, including both fruit and vegetable juice, 
to healthy dietary patterns as presented in the Dietary Guidelines, 
2020-2025 and Healthy U.S.-Style Dietary Pattern for ages 2 and older, 
we are including 100% fruit and vegetable juice among foods that are 
eligible to bear the ``healthy'' claim (Ref. 1). Additionally, we 
include in this rule a single-ingredient exemption for nutrient-dense 
foods that are encouraged by the Dietary Guidelines with no added 
ingredients, except for water (see Response 9).
    (Comment 20) Some comments do not support fruit puree and fruit 
paste being able to qualify for the ``healthy'' claim because, 
according to the comments, they often do not contain fiber-containing 
parts of the whole fruit and are seldom consumed independently. For 
example, if the whole fruit or vegetable is not used in making the 
purees or pastes, such as if the skin is removed from apples before 
making applesauce, then the purees could have lower fiber content than 
the whole fruit or vegetable.
    (Response 20) As stated in the proposed rule (87 FR 59168 at 
59184), FDA considers concentrated fruit and vegetable purees and 
pastes to be fruits and vegetables for the purpose of calculating FGEs 
because these products are essentially fruits and vegetables that have 
been processed to change the physical form of the fruit or vegetable 
and to remove moisture. While removal of the skin of fruits and 
vegetables for concentrated fruit and vegetable purees and pastes may 
affect total fiber content compared with whole, intact fruits and 
vegetables, the Dietary Guidelines, 2020-2025 includes purees, such as 
applesauce, in the food groups for fruits without qualification related 
specifically to fiber content. Fruits and vegetables provide a wide 
array of nutrients and are consumed in a wide variety of forms. Some 
forms of fruits and vegetables are consumed without skins, even when 
the skins are edible, such as in canned and frozen varieties. Even with 
the removal of fruits and vegetable skins, the overall nutrient 
profiles of purees and pastes remain within the range of the varied 
available forms of fruits and vegetables. For the development of the 
Healthy U.S.-Style Dietary Pattern, the FPED also included applesauce 
puree with a c-eq of 245 g. Similarly, pastes, such as tomato paste, 
are included in the food group for vegetables and the FPED provides a 
c-eq of 120 g. Fruit and vegetable purees and pastes are foods that are 
included in the fruit and vegetable food groups in the Dietary 
Guidelines. Thus, under the final rule, fruit and vegetable purees and 
paste are eligible to bear a ``healthy''

[[Page 106082]]

claim as individual vegetable foods, if they meet the applicable FGE 
and NTL criteria (see Sec.  101.65(d)(3)(ii)). Furthermore, fruit and 
vegetable pastes and purees that contain no other ingredients, except 
for the addition of water, would be included under the single-
ingredient exemption (see Response 9, Sec.  101.65(d)(3)(i)). In 
addition, although fruit pastes and purees can be used as ingredients 
in foods such as yogurts and bakery products, the mere presence of 
pastes and purees in those products does not enable such products to 
qualify for use of the claim. Food products, such as bakery products 
containing fruit pastes and purees, would continue to be evaluated 
based on the overall criteria set forth for their food category. 
Likewise, packaged products of fruit pastes and purees would be 
evaluated on the criteria set forth for fruit products, regardless of 
any potential use as ingredients in other food products.
5. FGE for Grains and Whole Grains
    (Comment 21) Many comments support the general approach to grain 
products (i.e., that grain products must contain a \3/4\ oz-eq of whole 
grains to bear the ``healthy'' claim) and mention that the approach 
supports consumers in achieving the Dietary Guidelines recommendation 
that at least half of total grains consumed be whole grains. However, 
some comments assert that grain products should have to meet additional 
criteria to qualify for the ``healthy'' claim, such as being required 
to be nearly 100% whole grain and minimally processed.
    (Response 21) We developed the FGEs to help consumers identify 
foods that can help them meet the recommended daily food group amounts 
as described in the Dietary Guidelines, 2020-2025 and the Healthy U.S.-
Style Dietary Pattern. Whole grains are grains that have the entire 
grain kernel, which includes the bran, germ, and endosperm, while 
refined grains have been processed to remove the bran and germ. Some 
refined grains are enriched. Enriched grain products are refined grains 
that have specific nutrients added back to replace losses of the 
nutrients that occur during processing (Ref. 4). Setting the FGE for 
grain products at \3/4\ oz-eq of whole grains helps consumers identify 
foods that can help them meet the recommended 3 oz-eq of whole grains 
per day. Although some comments suggest that grain products labeled 
``healthy'' should be entirely whole grains and/or minimally processed, 
we find that those conditions are unnecessary if the food contains an 
FGE of whole grains. A food that contains a full FGE of whole grains, 
but is not 100% whole grain or is processed, still contributes to 
meeting the recommended daily amount of 3 oz-eq of whole grains per 
day, which supports the primary objective of the FGEs. Therefore, we 
decline to require proportions of overall whole grains or processing 
limitations to whole grain foods beyond the criteria set in the 
definition. We note that the Dietary Guidelines 2020-2025 recommends 
that any refined grains that consumers choose be enriched grains.
    (Comment 22) Some comments request that we adjust the proposed FGE 
requirement for whole grains to align with the recommendations in the 
Dietary Guidelines, 2020-2025, which is 8 g of whole grains per 1 oz-eq 
(i.e., if half of the grains are whole grains). One comment provides 
that the Dietary Guidelines recommends 6 ounce-equivalents of grain 
foods per day, with at least half of those being whole grains. 
According to the comment, under the proposed rule, foods with 8 g whole 
grain per oz-eq that meet the nutrient limits for saturated fat, added 
sugars, and sodium would not qualify for the ``healthy'' claim. The 
comment suggests that FDA align the whole grain threshold with the 
recommendations in the Dietary Guidelines, 2020-2025 of 8 g per oz-eq. 
The comment also recommends that the requirements for the whole grain 
criteria be provided in grams present per reference amount.
    (Response 22) Although the Dietary Guidelines, 2020-2025 provides 
individuals with multiple strategies to facilitate shifts in eating 
habits, the primary objective of the food group recommendations is to 
help consumers meet the recommended 3 oz-eq of whole grains per day. 
Both the Dietary Guidelines, 2020-2025 and the FPED explain that a 1 
oz-eq of whole grains is 16 g of whole grains. The comments suggest 
that the criteria should align with one of the strategies to facilitate 
shifts in eating habits discussed in the Dietary Guidelines, 2020-2025 
to choose foods whose grain components are comprised of at least 50% 
whole grains, which would be 8 g per oz-eq. However, the FGE 
requirement for whole grains included in the updated ``healthy'' 
criteria is based on the Dietary Guidelines' recommended amount of 3 
oz-eq of whole grains per day. To determine the amount of FGE required 
for a food to bear the ``healthy'' claim, the recommended daily food 
group amounts are divided among the four eating occasions typically 
consumed. Consequently, the rule sets the FGE for grains at \3/4\ oz-eq 
of whole grains (see Sec.  101.65(d)(2)), which would be calculated as 
12 g of whole grains per RACC (16 g of whole grains multiplied by \3/
4\). Therefore, we are not lowering the amount of whole grains needed 
to qualify, as the goal of this FGE is to help consumers identify foods 
that can help them reach the 3 oz-eq per day recommended for whole 
grains. The strategies discussed in the Dietary Guidelines, 2020-2025 
to help people consume more whole grains can be helpful, however, and 
can be communicated to consumers in many ways, both on food labels and 
through communications and education outside of labeling.
    Additionally, we decline to shift to using gram amounts as the 
basis for compliance with the FGE requirements, as suggested by the 
comment. As discussed in Response 33, the concepts of cup and ounce 
equivalents incorporate the calculation of the specific gram weights of 
individual foods. The use of oz-eq for the whole grain FGE allows for 
the calculation of gram amounts for individual foods. FGEs in cup- and 
ounce-equivalents allow for the calculation of specific amounts of FGEs 
in foods, including in grams, that exist in a wide variety of forms and 
that could be measured in different measurement units.
    (Comment 23) Some comments on the whole grain FGEs request that we 
provide additional guidance and examples on how to calculate the FGEs. 
The comments also indicate that the FGE calculations could potentially 
exclude a wide variety of foods which are inherently whole grain, such 
as whole wheat flour, and foods made from whole grains, such as whole 
wheat bagels.
    (Response 23) We discuss some examples of resources for the 
determination of FGE amounts in Response 12. As noted in Response 12, 
the final rule sets a compliance date that is 3 years from the 
effective date, and we intend to provide additional resources to help 
manufacturers comply with the final rule before the end of the 
compliance period. Additionally, because of the single-ingredient 
exemption that we are providing (Sec.  101.65(d)(3)(i)), single-
ingredient whole grains that meet the criteria for the single-
ingredient exemption would automatically qualify for the claim without 
having to meet FGE or NTL criteria.
    (Comment 24) Several comments assert that refined grain foods with 
an inherent or fortified nutrient to encourage should be able to bear a 
``healthy'' claim as they can be part of a healthy dietary pattern and 
are encouraged by the Dietary Guidelines,

[[Page 106083]]

2020-2025. The comments mention that the Dietary Guidelines, 2020-2025 
does not require that all grains are whole, but instead encourages 
people to ``make half their grains whole'' and to choose enriched grain 
products when consuming refined grains. The comments provide that 
enrichment and fortification of grains improves intake of several 
nutrients, including nutrients such as iron and folate, which are 
critical for women of childbearing age.
    Some comments note that although FDA's food group approach to 
``healthy'' labeling is conceptually reasonable and may work well for 
some food groups, the approach raises concerns when applied to the 
grain group. The comments urge FDA to ensure that the ``healthy'' 
criteria do not unintentionally discourage consumption of other grain 
foods recommended by the Dietary Guidelines, including enriched grains, 
asserting that less than 8% of Americans consume the minimum 
recommendation for whole grain foods and that fiber is an underconsumed 
food component. The comments ask that the ``healthy'' labeling 
distinguish staple grain foods from ``indulgent grain products'' that 
should be consumed less often.
    Another comment asserts that the ``healthy'' nutrient content claim 
should allow refined or enriched grains to use the healthy claim if 
they provide a good or excellent source of fiber and meet the added 
sugar, saturated fat, and sodium limits. According to the comment, the 
main concern cited in the Dietary Guidelines, 2020-2025 regarding 
refined grains is that they commonly contain added sugar, sodium, and 
saturated fat. The comment states that if a product meets the criteria 
for added sugars, sodium, and saturated fat and contains one or more 
components of public health concern (i.e., those that are underconsumed 
in the U.S. population) at meaningful levels, that product should be 
included in a healthy eating pattern.
    (Response 24) As previously stated, the purpose of the ``healthy'' 
claim is to highlight those foods that are particularly useful in 
creating a diet that is consistent with current dietary guidelines. For 
grains consumption, the Dietary Guidelines, 2020-2025 states that 
healthy dietary patterns include whole grains and limit the intake of 
refined grains. While refined grains can be included in a healthy diet, 
the objective identified in the Dietary Guidelines, 2020-2025 is to 
meet the recommended daily amount of grain foods intake mostly through 
whole grains. Most Americans already meet the recommendations for 
overall grain intake in their diets. However, 98% do not meet the whole 
grain intake recommendations, and 74% consume more refined grains than 
recommended (Ref. 1). The ``healthy'' claim can help consumers identify 
the whole grain foods that are characteristic of a healthy dietary 
pattern so that they may shift grain consumption from predominantly 
refined grains to more whole grains. Although we recognize that some 
refined grain foods are staple foods for some groups and may contain 
important nutrients such as iron or fiber, they are not among the core 
elements included in healthy dietary patterns. For this reason, the 
FGEs for grain foods in the rule are set to a specific amount of whole 
grains, not refined grains (Sec.  101.65(d)(2)). Additionally, a food 
that contains a full FGE of whole grains, but is not 100% whole grain 
(i.e., also contains refined grains), could still meet the FGE criteria 
to qualify for the ``healthy'' claim. Even though the food is not 100% 
whole grain, it would still contribute to meeting the recommended daily 
amount of 3 oz-eq of whole grains, which supports the primary objective 
of the FGEs. While certain foods containing refined or enriched grains 
may not contain any whole grains, they could contain full FGEs from 
other food groups, such as vegetables. Based on the entire composition 
of the food product and the presence of other food group components, 
these products may also be able to qualify for the ``healthy'' claim.
    (Comment 25) A number of comments mention that the proposed rule 
would disqualify many grain foods, including the majority of ready-to-
eat cereals on the market, from using the term ``healthy.'' The 
comments note that research shows ready-to-eat cereal is one of the 
most affordable, accessible, and nutrient-dense breakfast choices a 
person can make.
    (Response 25) As discussed in the previous response, whole grains 
are core elements of a healthy dietary pattern; accordingly, the rule 
sets the grain FGE with whole grain requirements and does not include 
requirements for refined grains. Ready-to-eat cereals that are 
comprised primarily of refined grains instead of whole grains may not 
be able to meet the FGE for whole grains in the rule and qualify for 
use of the ``healthy'' claim. However, there are many cereals on the 
market that are made with whole grains, and our review of the current 
food marketplace showed that many of these cereals contain the rule's 
required FGE amount of whole grains (Ref. 2). Furthermore, while there 
are cereals made with whole grains that do not currently meet the FGE 
for whole grains in the rule, some have levels of whole grain that are 
close to the \3/4\ oz-eq FGE amount, and manufacturers could choose to 
reformulate the product to meet the rule's FGE requirement, should they 
want the product to qualify for the ``healthy'' claim.
    Ready-to-eat cereals currently made with refined grains, and those 
with whole grains in amounts that do not meet the required FGE amount, 
can still play a role in the diets of consumers. Foods that do not 
qualify for use of the claim are not necessarily ``unhealthy'' or 
unable to provide any nutritional benefits to consumers. As previously 
discussed, the purpose of the ``healthy'' claim is to highlight those 
foods that are particularly useful in creating a diet that is 
consistent with current dietary guidelines. Ready-to-eat cereals, 
especially those without or with low levels of added sugars, sodium, 
and saturated fat, can provide numerous nutrients, such as iron or 
folate, and manufacturers can continue to communicate those nutritional 
attributes in many different ways.
    (Comment 26) One comment requests lowering the proposed \3/4\ oz-eq 
of whole grain per RACC requirement for products with a RACC of 15 g or 
less to 0.375 oz-eq per RACC. The comment expresses that many of its 
products that mainly contain whole grains would be unable to qualify as 
``healthy'' under the proposed rule because, given their small RACC, 
they would not be able to meet the \3/4\ ounce-equivalent of whole 
grain.
    (Response 26) As discussed earlier, we acknowledge that certain 
foods recommended by current nutrition science and Federal dietary 
guidance would be unable to meet the proposed criteria for the healthy 
claim due to being typically consumed in small amounts. Therefore, the 
rule now applies the ``healthy'' criteria to individual foods with a 
RACC of 50 g or less or 3 Tbsp or less on a per 50 g basis instead of a 
per RACC basis (see Sec.  101.65(d)(3)(ii)). Applying the ``healthy'' 
criteria to grain products that have RACCs of 15 g on a 50 g basis, 
results in foods of this RACC size to meet the FGE of \3/4\ oz-eq of 
whole grains. For example, a grain food with a RACC of 15 g that 
contained 0.375 oz-eq of whole grains, which would be equal to 6 g of 
whole grains, can qualify on a per 50 g basis. The calculated amount of 
whole grains in that food would be 20 g of whole grains per 50 g (50 g 
divided by 15 g and then multiplied by 6 g and then rounded up to 20 
g). This food qualifies for the FGE of \3/4\ oz-eq (12 g). Therefore, 
lowering the FGE amount, as suggested in the comment, is unnecessary, 
and the

[[Page 106084]]

concern raised by the comment is addressed by the fact that foods of 
that RACC size can now meet the whole grain FGE on a per 50 g basis. As 
such, we decline to lower the FGE amount. The final rule retains the 
FGE requirement for grains of \3/4\ oz eq whole grains (Sec.  
101.65(d)(3)(ii)(B)).
    (Comment 27) Some comments express that FDA's sole focus on whole 
grains as the criteria for grain products to qualify for the 
``healthy'' claim is overly simplistic and would not address the 
Dietary Guidelines recommendations of a balanced diet. The comments 
request that FDA provide updated educational resources for consumers on 
choosing all types of grains, including enriched refined grains without 
solid fats or sugars, to meet Dietary Guidelines recommendations.
    (Response 27) The objective of the Dietary Guidelines, 2020-2025 is 
to encourage consumption of those foods and food groups that are common 
in healthy dietary patterns, and the ``healthy'' claim can help 
consumers identify foods that are particularly useful in helping them 
achieve a diet consistent with current dietary recommendations. We 
explained earlier why the criteria for the ``healthy'' claim will focus 
on whole grains and not refined grains, as whole grains are core 
elements of healthy dietary patterns. For the same reasons, we intend 
to focus our educational efforts on consumption of whole grains. We 
have, however, expressed throughout this rule that foods that are 
unable to qualify for the ``healthy'' claim are not ``unhealthy'' and 
can still be incorporated as part of a healthy dietary pattern. We plan 
to also incorporate this messaging in consumer education efforts 
related to the ``healthy'' claim.
    (Comment 28) One comment asserts that the labeling of grain foods 
is confusing in part due to misleading advertising and encourages FDA 
to improve the labeling of whole grains to improve transparency for 
consumers. The comment asks that whole grain products that meet the 
criteria for the ``healthy'' labeling claim be required to disclose the 
percentage of both whole and refined grains.
    (Response 28) We have determined that setting the FGE for grain 
products at \3/4\ oz-eq of whole grains helps consumers identify foods 
that can help them meet the Dietary Guidelines, 2020-2025 recommended 3 
oz-eq of whole grains per day. A food that contains a full FGE of whole 
grains, but is not 100% whole grain, still contributes to meeting the 
recommended daily amount of 3 oz-eq, which supports the primary 
objective of the FGEs. For these reasons, we decline to require 
additional information about grain content or any other qualifying 
criteria as part of the ``healthy'' claim. However, if manufacturers 
choose to do so, they may use other claims and truthful and non-
misleading statements about the nutritional qualities of their foods in 
addition to the use of the ``healthy'' claim. For example, a food that 
bears a ``healthy'' claim could also make claims about whole grain or 
fiber content, provided that the food meets all applicable requirements 
for such claims.
6. FGE for Dairy
    (Comment 29) Some comments disagree with the proposed \3/4\ c-eq 
per RACC for the dairy group to qualify for the ``healthy'' claim, 
stating that it is confusing to consumers and places an unnecessary 
burden on industry. The comments assert that the \3/4\ c-eq for dairy 
is less actionable for consumers because it does not equate to a 
recommended serving as provided in the Dietary Guidelines.
    Some comments urge FDA to adopt an FGE of \1/2\ c-eq dairy for 
natural cheese. The comments note that few cheeses would qualify for 
the ``healthy'' nutrient content claim under the proposed ``healthy'' 
definition. A number of comments assert that using the proposed \3/4\ 
c-eq for dairy would cause many cheeses, including fat-free or low-fat 
forms, to be unable to bear the ``healthy'' claim, based solely on the 
amount of serving equivalents set by the Dietary Guidelines, 2020-2025 
and the defined RACCs. The comments also state that it may be difficult 
to determine whether a cheese is eligible for a healthy claim, because 
cheeses have varying weights and densities.
    (Response 29) In response to these comments, we reviewed the 
current marketplace related to the RACC sizes of different dairy 
products and the amounts of FGEs contained in those foods (Ref. 2). 
This review showed that the comments were correct that a number of 
dairy foods, including some cheeses and many yogurts, would not meet 
the proposed FGE of \3/4\ c-eq of dairy. However, the amount of dairy 
in many of those products was close to meeting the FGE amounts (ranging 
from about 0.69 to 0.71 c-eq per RACC). Dairy products, including milk, 
yogurt, and cheese, especially in fat-free and low-fat forms, are 
included in the Dietary Guidelines, 2020-2025 as core elements of 
healthy dietary patterns. Although the proposed FGE threshold was set 
to help consumers identify foods that could help them meet the 
recommended daily amount of dairy, we do not intend to exclude 
nutrient-dense foods that are recommended for healthful dietary 
patterns. We have already addressed the issue of foods with small RACCs 
in Response 8 and the methods provided for addressing small RACC foods 
will result in many dairy foods with small RACCs, such as natural 
cheeses, being able to meet the FGE amounts. However, there are some 
other dairy foods that do not have small RACCs and that still would not 
meet the FGE amounts. Therefore, we have revised the FGE threshold for 
dairy in the rule to \2/3\ c-eq per RACC (see Sec.  101.65(d)(2)). 
Examples of \2/3\ c-eq of dairy are \2/3\ cup fat-free or low-fat milk, 
yogurt, or lactose-free versions of these products, or fortified soy 
beverage or yogurt alternatives; and 1 oz natural cheese or \2/3\ oz 
processed cheese.
    As discussed, the FGE threshold was set to help consumers identify 
foods that could help them meet the recommended daily amount of dairy, 
which is 3 c-eq per day. With an FGE set at \2/3\ c-eq and an 
opportunity for consumption at four eating occasions per day, the daily 
amount achieved would be 2 \2/3\ c-eq of dairy per day (\2/3\ c-eq 
multiplied by four), and the total amount consumed would be close to 
the recommended 3 c-eq daily intake. Setting the FGE at a lower level 
will result in more dairy foods being able to meet requirements for the 
``healthy'' claim, which could provide more dairy options labeled as 
``healthy'' for consumers to choose from. Dairy products are 
underconsumed in the United States, with 90% of consumers not meeting 
the daily recommendation currently (Ref. 1). The adjustment to the 
dairy FGE is similar to how adjustments were made to some FGEs in the 
proposed rule, such as the vegetable food group, which is also 
underconsumed. Because vegetables are underconsumed with 90% of 
consumers not meeting the vegetable intake recommendation, the FGE 
amount was slightly rounded down to \1/2\ c-eq. Setting the FGE 
requirements for underconsumed food groups at a slightly lower amount 
makes it easier for foods in those groups to qualify for the claim and 
allows for more foods on the market to be labeled ``healthy.'' More 
nutrient-dense dairy options being able to be labeled as ``healthy'' 
may help consumers in identifying and choosing nutrient-dense dairy 
options that can help them meet the daily recommendation.
    Although some comments suggest setting the FGE threshold at even 
lower amounts than \2/3\ c-eq, such as \1/2\ c-eq, amounts lower than 
\2/3\ c-eq would make meeting the daily recommended amount

[[Page 106085]]

for dairy difficult. Requiring a minimum of \2/3\ c-eq for the dairy 
FGE to meet the FGE requirement for the ``healthy'' claim would enable 
consumers to identify dairy products that would help them approach 
meeting the daily recommended amounts for dairy and result in many 
nutrient-dense dairy options qualifying for the ``healthy'' claim. We 
note that the FGE amounts are criteria for manufacturers to use when 
determining if a product qualifies for the ``healthy'' claim. The 
presence of a ``healthy'' claim on a product that meets the criteria 
will simply help consumers to identify foundational foods for building 
healthy dietary patterns. To support this goal, we intend to engage in 
consumer education efforts related to the ``healthy'' claim.
    (Comment 30) One comment notes that there are disparities in dairy 
consumption related to race and ethnicity, with non-Hispanic Black and 
Asian children and adults consuming the least amount of dairy. The 
comment also mentions that lactose intolerance is significantly more 
prevalent among Black and Hispanic Americans than in non-Hispanic white 
populations, and that natural cheeses such as cheddar, mozzarella, and 
Monterey Jack are ``virtually lactose-free'' dairy options upon which 
individuals with lactose intolerance rely. According to the comment, 
limiting the labeling of cheese as a ``healthy'' food could further 
widen the disparity gap in dairy consumption. The comment asserts that 
dairy consumption needs to be encouraged across age, race, and ethnic 
groups to achieve the daily dairy recommendation as a part of healthy 
eating patterns to help advance health equity. Some comments note that 
plant-based dairy foods are alternative dairy sources for those with 
lactose intolerance.
    (Response 30) The criteria for foods to bear the ``healthy'' claim 
are intended to help consumers identify foods that are foundational to 
a healthy dietary pattern. As noted in Response 29, we have lowered the 
FGE amount for dairy to \2/3\ c-eq, which will result in more dairy 
foods being able to meet the FGE requirements for the ``healthy'' claim 
and may result in more dairy options labeled as ``healthy'' for 
consumers to choose from (e.g., more yogurts). There are other options 
in the dairy group for individuals who are lactose intolerant that 
could qualify for ``healthy,'' such as certain lactose-free versions of 
dairy products or certain dairy products that are naturally lactose-
free. Also, fortified soy milk, and plant-based dairy alternatives with 
similar nutrient composition as dairy are included in the dairy food 
group for the purposes of the ``healthy'' claim, which can provide 
alternatives to individuals who are lactose-intolerant. The Dietary 
Guidelines, 2015-2020 discusses that key nutrient contributions from 
dairy foods include calcium, protein, vitamin A, vitamin D, magnesium, 
phosphorous, potassium, riboflavin, vitamin B12, zinc, choline, and 
selenium (Ref. 4). As we noted earlier in this rule, while not all 
dairy foods may qualify for use of the claim, the use of the 
``healthy'' claim on some foods is not intended to signal that all 
other foods are ``unhealthy,'' including foods consumed by certain 
subgroups of the population (see section III.A (``Need for the 
Regulation/History of This Rulemaking''). Other foods are still 
available for consumption and manufacturers can communicate truthful 
and non-misleading information about lactose-free foods or information 
that encourages culturally appropriate consumption of dairy foods on 
the food label outside of use of the ``healthy'' claim.
    (Comment 31) Some comments assert that ambiguity in the 
determination of the FGEs of certain dairy foods, including yogurt, 
could lead to inconsistency in manufacturer calculations of FGEs and 
confusion among consumers. A number of comments request that FDA 
provide a list, examples, or maintain a database for manufacturers to 
use in calculating the amount of FGEs delivered by each food.
    (Response 31) The comments on the dairy FGEs echoed the requests in 
the comments across the food groups for guidance in determining the FGE 
amounts for foods in this group. We provide a general discussion on 
available resources to support determination of FGE amounts in Response 
12. For example, fluid milks and yogurts are calculated at 245 g for a 
one c-eq in the FPED database (Ref. 3). As noted in Response 12, the 
final rule sets a compliance date that is 3 years from the effective 
date, and we intend to provide additional resources to help 
manufacturers comply with the final rule before the end of the 
compliance period.
    (Comment 32) Some comments request guidance regarding what dairy 
alternatives might be considered ``healthy.'' Some comments note that, 
according to the Dietary Guidelines, alternative beverages such as 
almond, rice, coconut, or hemp milks are not nutritionally equivalent 
to milk and are therefore not included in the dairy foods group. The 
comments note that dairy foods contribute nutrients such as calcium, 
vitamin D, and potassium to the American diet. One comment provides 
that, according to the Dietary Guidelines, only fortified soy products 
are nutritionally similar to dairy products and can serve as a 
replacement to dairy products. However, other comments support the 
inclusion of plant-based dairy alternatives in the dairy group. The 
comments mention that many people do not consume dairy products for a 
variety of reasons, such as allergy, intolerance, cultural practices, 
or preference. Many comments that support inclusion of plant-based 
dairy alternatives in the dairy group request that FDA set forth 
specific nutritional criteria that plant-based dairy alternatives must 
meet to qualify for the ``healthy'' claim. One comment asserts that if 
FDA permits nutritional comparisons between plant-based and traditional 
dairy products through the use of the term ``healthy,'' then FDA should 
require the plant-based products to bear the imitation labeling 
outlined in Sec.  101.3(e) (21 CFR 101.3(e)).
    (Response 32) In the proposed rule (87 FR 59168 at 59187), we 
determined that including fortified plant-based dairy alternatives 
among the food options in the dairy group can help consumers identify 
foods that can help them increase their dairy group intake and meet the 
dairy group daily intake recommendations. We specifically limited 
plant-based milk alternatives and plant-based yogurt alternatives that 
could qualify for the claim to those products whose overall nutritional 
content is similar to dairy foods (e.g., provide similar amounts of 
protein, calcium, potassium, vitamin D, and other nutrients) and are 
used as alternatives to milk and yogurt. We discussed in the proposed 
rule that, when the Dietary Guidelines, 2020-2025 published, fortified 
soy beverages and yogurts were the only alternatives that were 
nutritionally comparable to dairy, and the composition data evaluated 
by the Dietary Guidelines, 2020-2025 demonstrated that the nutrient 
content in fortified soy beverages and yogurts is similar to that of 
dairy. Plant-based dairy alternatives are formulated foods, with 
evolving compositions and formulations. It is possible that plant-based 
dairy alternatives from sources other than soy, such as almond milk or 
oat milk, may be produced with nutritional profiles similar to dairy. 
If plant-based dairy alternatives are formulated with nutritional 
profiles similar to that of dairy, then it would be appropriate for 
those products to be considered among the food options in the dairy 
group. Although not mentioned in the proposed rule, in

[[Page 106086]]

addition to plant-based milk and yogurt alternatives, plant-based 
cheese alternatives are also available on the market. Currently, these 
plant-based cheese alternatives do not have similar nutrient 
composition to cheese. However, as with plant-based milk and yogurt 
alternatives, it is possible that in the future plant-based cheese 
alternatives may be produced with nutritional profiles similar to that 
of dairy. If those food products were to become available, they would 
be considered under the criteria for the dairy group to qualify for use 
of the ``healthy'' claim. We reiterate that, for purposes of this rule, 
it is only those plant-based dairy alternatives that have similar 
nutrition composition to dairy that will be included in the dairy group 
for purposes of qualifying for the ``healthy'' claim. For example, soy-
based yogurt alternatives would need to have similar nutrient 
composition to traditional milk-based yogurt. Plant-based milk 
alternatives would, likewise, need to have similar nutrient composition 
to milk to be considered under the criteria for dairy foods in this 
rule. While nutrient profiles can vary among different dairy foods, the 
Dietary Guidelines, 2015-2020 discusses that key nutrient contributions 
from dairy foods include calcium, protein, vitamin A, vitamin D, 
magnesium, phosphorous, potassium, riboflavin, vitamin B12, zinc, 
choline, and selenium (Ref. 4). We note that FDA has also published a 
draft guidance on the labeling of plant-based milk alternatives, and we 
requested comment on nutrient profiles of plant-based milk alternatives 
(Ref. 5). Requiring plant-based products to bear imitation labeling as 
outlined in Sec.  101.3(e) is outside the scope of this rule.
    (Comment 33) Some comments question the use of FGEs, cup- and 
ounce-equivalents for the criteria for dairy foods. One comment notes 
that FDA has departed from the use of a defined gram-basis, the RACC, 
or labeled serving size as the basis for the ``healthy'' claim, without 
explanation. The comment urges FDA to consider a basis that is specific 
to certain types of dairy foods or the RACC.
    (Response 33) The claim ``healthy' is a nutrient content claim and 
the criteria are applied on a per RACC basis, as is typically the case 
with nutrient content claims. The NTL criteria in the ``healthy'' 
definition are based on grams or milligrams per RACC, similar to other 
claims, but are reflected as percentages of the DV to allow flexibility 
in the future if there are changes in the DV for these nutrients. The 
FGE criteria introduced in the ``healthy'' definition are applied on a 
cup- and ounce-equivalent per RACC basis to be consistent with how food 
group recommendations are provided for in relation to dietary patterns. 
The Dietary Guidelines, 2020-2025 provides food group recommendations 
in cup- and ounce-equivalents, such as 3 c-eq of dairy per day for a 
reference 2,000-calorie diet. The daily recommended amounts of the food 
groups are spread out throughout the day across an individual's eating 
occasions. Therefore, the amounts per eating occasion are also in cup- 
and ounce-equivalents. The concept of equivalents, however, 
incorporates the calculation of the specific gram weights of individual 
foods. In the example used earlier in this section for fluid milk and 
yogurt, 245 g is a one c-eq, as calculated in the FPED database. 
Calculating the FGE of \2/3\ c-eq results in an FGE amount of 
approximately 163 g for milk and yogurt. The use of cup- and ounce-
equivalents allows for the calculation of specific amounts of foods 
that exist in a wide variety of forms.
    (Comment 34) One comment asserts that FDA is providing plant-based 
dairy alternative products a competitive advantage because 
manufacturers of these products may choose between two different FGEs 
(protein foods or dairy).
    (Response 34) As discussed in Response 35, there are some foods, 
namely beans, peas, and lentils, that may be considered under either 
the protein or the vegetable food group for calculation of FGEs. 
However, plant-based dairy products that are labeled and marketed as 
dairy alternatives will be evaluated against the criteria for the dairy 
food group for the purposes of the ``healthy'' claim, as discussed in 
Response 32. Therefore, manufacturers of plant-based dairy alternative 
products are not able to choose between two different food groups for 
the calculation of FGEs.
7. FGEs for Protein Foods
    (Comment 35) One comment says that dry beans, dry peas, lentils, 
and chickpeas, known as pulses, are rich sources of protein, potassium, 
and dietary fiber, and provide other important minerals, such as 
magnesium, choline, and iron, and minimal amounts of added sugar, 
saturated fat, and sodium to the diet. The comment supports FDA's 
proposal to permit beans, peas, and lentils to be categorized as either 
a vegetable or a protein under the rule because the nutrient content is 
similar to other foods in both the protein and vegetable groups. The 
comment asserts that pulses are emerging in a variety of new forms, 
including flours, powders, spreads, purees, pastas, and proteins, and 
can be used in a wide variety of applications, such as pastas, plant-
based entrees, baked goods, and beverages. The comment asserts that 
these varying forms contain the same nutritional benefits of pulses in 
their whole form and maintains that FDA should provide flexibility to 
allow for innovative pulse products to qualify as ``healthy.''
    Other comments request that other sources of protein, including 
protein powders, isolates, and concentrates from whey, soy, and pea, be 
included in the protein foods group. The comments note that the Dietary 
Guidelines, 2020-2025, includes soy flour, soy protein isolate, and soy 
concentrate in the protein group and provides that soy includes tofu, 
tempeh, and products made from soy flour, soy protein isolate, and soy 
concentrate. The comments assert that all plant-based proteins should 
be considered part of the protein foods group.
    (Response 35) In the proposed rule (87 FR 59168 at 59185), we 
stated that for individual foods, 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. 
Similarly, for combination foods, we proposed that beans, peas, and 
lentils could be counted as either a protein food or as a vegetable in 
a combination food (87 FR 59168 at 59191). Our position has not changed 
on beans, peas, and lentils and these foods can be considered under 
either of those food groups to qualify for the claim in this final 
rule. For consideration as vegetables, the FGEs for beans, peas, and 
lentils is \1/2\ c-eq per RACC and for consideration as protein foods, 
the FGE is 1 oz-eq per RACC, consistent with the Dietary Guidelines, 
2020-2025 (Sec.  101.65(d)(3)(ii)).
    The daily recommendation for protein foods in the Healthy U.S.-
Style Dietary Pattern at the 2,000-calorie level is 5\1/2\ oz-eq. For 
all the food groups, we calculated the FGE by dividing the daily amount 
by four eating occasions (5\1/2\ oz equivalents of protein foods 
divided by four is 1\3/8\ oz-eq). For the beans, peas, and lentils sub-
category of protein foods, we set the FGE at 1 oz-eq, which is lower 
than 1\3/8\ oz-eq. We proposed rounding down to 1 oz-eq to increase the 
number of products containing these subgroups that would be eligible to 
bear the claim, consistent with the Dietary Guidelines, 2020-2025, 
which encourages consumption of such products (87 FR 59168 at 59188). 
The rule maintains the 1 oz-eq FGE for beans, peas, and lentils as it 
provides

[[Page 106087]]

sufficient flexibility for a variety of options of nutrient-dense 
protein foods, including pulses, to be eligible for the claim, which 
may help consumers identify foods that help them meet the daily 
recommended amount of protein foods. We decline to include protein 
isolates and concentrates when calculating what meets the FGE 
requirement for the protein group. The Dietary Guidelines, 2020-2025 
recommends following a healthy dietary pattern with a focus on meeting 
food group needs by consuming a variety of nutrient-dense foods and 
beverages and staying within calorie needs. Although the Dietary 
Guidelines, 2020-2025 includes soy protein isolates and concentrates 
among examples of foods in the protein foods group, these components 
will not count toward meeting the FGEs for the protein foods group in 
the rule. The food group approach to the ``healthy'' claim represents a 
shift from focusing on individual nutrients to nutrient-dense foods. 
Nutrients that are extracted from foods, such as isolates and 
concentrates, are not whole, nutrient-dense foods but rather, 
individual nutrients such as those included in the original definition 
for the ``healthy'' claim. Because of the shift in the framework toward 
foods rather than individual nutrients, counting isolated or 
concentrated protein toward the protein FGEs would not be consistent 
with the ``healthy'' claim's focus on nutrient-dense foods that serve 
as the foundation of healthy dietary patterns. The presence of 
extracted components, such as isolates or concentrates, and information 
about any potential benefits, however, may be useful to consumers and 
manufacturers may communicate this information in other ways, (e.g., 
nutrient content claims, health claims, and other truthful and non-
misleading statements on the label).
    (Comment 36) One comment asks that FDA provide additional guidance 
about converting all forms of pulses into c-eq as a vegetable or into 
ounce equivalents as protein. The comment mentions that the proposed 
rule does not include information regarding how to account for changes 
in volume from processing such as milling, grinding, chopping, 
pureeing, dehydrating, and cooking, and asks FDA to provide calculation 
guidance to help in determining compliance with the FGE criteria.
    (Response 36) We provide information about available resources to 
support determination of FGE amounts in Response 12. For example, the 
FPED provides c-eq for beans and provides amounts for different forms 
such as cooked, uncooked (dry), and canned (Ref. 3). For varieties of a 
food that are cut pieces of the whole form, as with beans that are 
chopped, sliced, or ground, the total amount of food in a c-eq of whole 
food and the cut food would be the same. As noted in Response 12, the 
final rule sets a compliance date that is 3 years from the effective 
date, and we intend to provide additional resources to help 
manufacturers comply with the final rule before the end of the 
compliance period.
    (Comment 37) One comment requests additional clarity regarding 
plant-based foods, including how ingredients like chickpea powder or 
legume powder would be treated and whether pea milk, almond milk, and 
other plant-based milks, whether fortified or not, would be considered 
protein foods.
    (Response 37) Powders of protein products, such as chickpea powders 
or legume powders, can be included in FGE calculations provided that 
the powders are essentially the dried/dehydrated and ground forms of 
the original, whole food. Powders that have ingredients added to them 
or components of the food removed from them (other than water) would 
not be considered a form of the original food for the purposes of the 
``healthy'' claim. The FPED provides an example for legumes, 
specifically soy flour, which has a 1 oz-eq of \1/2\ oz (~14 g) (Ref. 
3). Plant-based milk alternatives, such as pea milk or almond milk, 
would be evaluated against the criteria for the dairy food group and 
not the protein foods group and are discussed in the dairy section 
V.C.6 (``FGEs for Dairy'').
    (Comment 38) A number of comments seek clarification as to whether 
coconut is considered a nut. One comment mentions that coconut is 
currently classified as a tree nut under the Food Allergen Labeling and 
Consumer Protection Act and provides that the saturated fat of a 
coconut is inherent to the coconut, as is the case with nuts. Other 
comments note that they are excluding coconut from their discussion of 
nuts and seeds (and would not support exclusion of saturated fat 
content of coconut from the overall saturated fat limit, as was 
proposed for nuts and seeds) because coconut is unusually rich in 
saturated fat.
    (Response 38) While a coconut is botanically a fruit (specifically, 
a fibrous one-seeded drupe), the Dietary Guidelines, 2020-2025 does not 
include coconuts in the nut or the fruit category. In addition, the 
FPED database used in the modeling of the U.S. Food Patterns describes 
the ``Nuts and Seeds'' category as ``Peanuts, tree nuts, and seeds; 
excludes coconut'' (Ref. 3). Instead, the FPED considers coconuts to be 
solid fats, listing coconuts with other examples of solid fats as 
``Coconut meat, raw--Raw coconut meat containing 33.5 grams of fat per 
100 grams.'' Because coconut meat contains total fat amounts of over 33 
g per 100 g and most of the fat is saturated (29.7 g per 100 g) (Ref. 
7), we have determined that coconuts will not be counted as 
contributing toward the protein foods group (i.e., will not be 
considered a nut) or the fruit food group, consistent with the Dietary 
Guidelines, 2020-2025.
    (Comment 39) Many comments request that FDA enable protein foods 
with small serving sizes to meet the definition of ``healthy.'' One 
comment notes that there are a number of nutrient-dense pulse products, 
such as hummus and roasted chickpeas, that would fall into the 
``individual foods'' category but have small RACC serving sizes. The 
comment asserts that even though these foods provide important 
nutrients like dietary fiber and protein while providing minimal 
amounts of added sugar, saturated fat, and sodium, it is mathematically 
impossible for these small serving sizes to provide the minimum amounts 
of food groups required by the proposed rule criteria. The comment 
requests that FDA create a pathway for nutrient-dense foods with small 
RACCs and serving sizes to meet the definition of ``healthy.'' The 
comment mentions this could be achieved by allowing products with small 
RACCs and serving sizes that meet the maximum limits for added sugar, 
saturated fat, and sodium, to meet the ``healthy'' definition if their 
first listed ingredient is an NTE. The comment mentions another 
approach would be to require a smaller amount of FGE for these smaller 
sized products, such as \1/4\ FGE.
    (Response 39) As discussed in Response 8, we do not intend to 
exclude nutrient-dense foods consumed in small amounts that are 
recommended for healthful dietary patterns, including certain protein 
foods. The final rule includes criteria specific to foods with small 
RACC sizes in Sec.  101.65(d)(3)(iii)(B). Under the small RACC 
criteria, foods with a small RACC size (<=50 g) need to meet the 
criteria per 50 g, which will result in many foods with small RACC 
sizes being able to meet the FGE amounts. Additionally, with the 
expanded exemption for single-ingredient foods in Sec.  
101.65(d)(3)(i), as further discussed in Response 9, many foods with 
both larger RACC sizes and small RACC sizes, such as roasted chickpeas, 
will automatically qualify for the claim, as long as no other 
ingredients except for water are added.

[[Page 106088]]

    The comments also mention hummus as a food with a small RACC that 
may not be able to qualify for the claim. Hummus, which has a RACC of 2 
Tbsp, is a mixed product with a number of ingredients. Mixed products, 
such as hummus, would need to meet the applicable FGE amounts in 
addition to the NTL criteria to qualify for the claim, as discussed in 
section V.E.2 (``Mixed Products'').
    (Comment 40) One comment supports FDA's inclusion of soy foods and 
soy milk in the rule but requests that we align the rule with FDA's 
authorized health claims and qualified health claims under 21 CFR 
101.14. The comment notes that many soy foods are not eligible for the 
proposed ``healthy'' claim even though they are eligible for FDA 
authorized health claims and qualified health claims.
    (Response 40) Foods and food components that are the subjects of 
health claims that FDA has authorized or for which it considers the 
exercise of enforcement discretion have an evidence-based relationship 
of risk reduction with a disease or health-related condition and the 
language in the health claim communicates this specific relationship. 
Although many foods that are the subjects of health claims do meet the 
requirements of the ``healthy'' nutrient content claim, not all foods 
that are the subject of a health claim are core elements of a healthy 
dietary pattern, and therefore would not necessarily qualify to bear 
the ``healthy'' claim (see section III. (``Background'') for further 
discussion of differences between different nutrition labeling claims).
    Whether and how a soy food qualifies for ``healthy'' depends on the 
food's specific nutrient profile and role in the diet. Some soy foods, 
such as soybeans, qualify under the single-ingredient exemption (see 
Response 9). Other foods made from soybeans would be subject to the FGE 
amounts and NTL criteria for dairy (e.g., soy milk) or for nuts, seeds, 
and soy products (e.g., tofu) to qualify for the ``healthy'' claim.
8. FGEs for Oils
    (Comment 41) A number of comments express support for FDA's 
proposal to include oils, which includes 100% oils, certain oil-based 
spreads (i.e., those whose fat content comes solely from oil), and 
certain oil-based dressings (i.e., those containing at least 30% oil 
and made from oils that meet the ``healthy'' definition) as a food 
group, viewing this as consistent with current nutrition science. The 
comments note that the Dietary Guidelines, 2020-2025 does not 
categorize oils as a ``food group'' but emphasizes that oils are one of 
the six core elements of a healthy dietary pattern and recommends daily 
intake objectives for oils like the food groups.
    Some comments do not support including ``oils'' as a food group. 
The comments express that allowing oils to be labeled as healthy may 
unintentionally communicate to consumers that oils are healthy in any 
amount and could lead to consumer confusion and overconsumption.
    (Response 41) Healthy dietary patterns include foods such as 
vegetable oils with unsaturated fats and are lower in foods high in 
saturated fats, such as butter, shortening, lard, or coconut oil (Ref. 
1). Strategies to shift intakes toward achieving a healthy dietary 
pattern include cooking with vegetable oils instead of fats like 
butter. Therefore, to reflect these shifts, as discussed in the Dietary 
Guidelines, we conclude it is appropriate for certain oils and oil-
based products to qualify for the ``healthy'' claim. We are not, 
however, establishing an FGE for oils in foods made with these oils and 
oil-based products. We disagree with and are not aware of any 
information in the comments or elsewhere supporting the argument that 
including oils as a food group for the purposes of this rule may lead 
to consumer confusion and overconsumption. We note that we do intend to 
address oil consumption in our consumer education efforts related to 
the ``healthy'' claim.
    (Comment 42) Some comments do not support allowing oil-based 
spreads and oil-based dressings to qualify to use the ``healthy'' claim 
due to concerns that many of these products contain ultra-processed or 
highly processed oil or other ingredients.
    (Response 42) Oils are characteristic components of healthy dietary 
patterns, and this determination reflects that current dietary 
recommendations encourage a shift from use and consumption of saturated 
fats, such as in butter and many salad dressings, to spreads and 
dressings made predominantly of unsaturated oils. The oils in these 
foods may be processed to a greater degree than fats such as butter or 
lard; however, healthy dietary patterns which include unsaturated oils 
rather than fats high in saturated fats are associated with positive 
health outcomes (Ref. 1).
    (Comment 43) One comment recommends that the requirement for oil-
based dressing to have at least 30% oil be lowered to a level of 10% 
oil.
    (Response 43) The replacement of oils for solid fats in the diet is 
a key reason for the inclusion of oils as core elements of healthy 
dietary patterns. Shifts from solid fats to unsaturated oils are 
important strategies for constructing healthy dietary patterns. 
Therefore, 100% oils and oil-based dressings and spreads that meet 
specific requirements can qualify for the ``healthy'' claim. Foods that 
are described as ``oil-based'' for the purposes of the ``healthy'' 
claim are not intended to identify foods that simply have oils as an 
ingredient. Rather, the foods identified as oil-based are intended to 
be foods where oil is a primary component. At >=30%, oils would 
typically make up the largest component in the food, with the exception 
of water. Lowering the oil requirement to >=10%, however, would not 
ensure that the food is an oil-based dressing with oils as the largest 
component, except for any water present. As discussed in the proposed 
rule, we did not set qualifying FGEs for the oils group, but instead, 
limit use of the claim to the oils themselves, oil-based dressings, and 
oil-based spreads, provided they meet the specified criteria. We 
decline to lower the minimum amount of required oil in oil-based 
dressings in the rule to 10% oil, consistent with the purpose of the 
claim and the Dietary Guidelines, 2020-2025.
9. FGEs for Fruit and Vegetable Powders
    (Comment 44) In the proposed rule, we did not consider vegetable or 
fruit powders to be vegetables or fruits, respectively, for the purpose 
of calculating FGEs. Some comments support this approach. One comment 
asserts that vegetable powders should not qualify as vegetables for 
purposes of the rule because vegetable powders may 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 the nutrient content. The comment 
notes that diets high in vegetables and fruits are beneficial, in part, 
because the vegetables and fruits displace other less healthy foods, 
and states that it is unlikely that foods made with vegetable powders 
would have the same effect. The comment expresses concern that allowing 
a product with no recognizable vegetable in it to bear the ``healthy'' 
claim would send the wrong message to consumers. Another comment agrees 
with the exclusion of vegetable and fruit powders on the basis that 
they are often used to create ultra-processed snack foods such as 
vegetable sticks, puffs, and other snack foods that the comment 
describes as high in fat and salt and low in dietary fiber.
    Other comments recommend that fruit and vegetable powders, or 
certain fruit and vegetable powders (e.g., those with

[[Page 106089]]

similar nutrient composition as whole fruits and vegetables), be able 
to contribute to FGEs. For example, some comments ask that FDA allow 
fruit and vegetable powders that are not derived from juice to 
contribute to the fruit and vegetable food groups and ask that FDA 
provide guidance for calculating FGE contributions from fruit and 
vegetable powders. Several comments provide information or data 
demonstrating that different fruit and vegetable powders have similar 
nutrient composition as whole fruits and vegetables. For example, one 
comment provides an assessment of fresh, dried, and powdered legumes to 
support the inclusion of powdered fruits, vegetables, and legumes under 
the ``healthy'' definition. The comment relies on data from the USDA 
Standard Food Database to demonstrate that the nutritional composition 
of whole chickpeas, black beans, and navy beans are substantially 
similar to the powdered forms. The comment provides that chickpea 
flour, meal, and grits contain more protein and higher dietary fiber 
levels than a whole, raw chickpea, and mentions that USDA reports 
similar results for black beans and navy beans. The comments also note 
that FDA has recognized in its guidance, Nutrition and Supplement Facts 
Labels: Questions and Answers Related to the Compliance Date, Added 
Sugars, and Declaration of Quantitative Amounts of Vitamins and 
Minerals, that fruit and vegetable powders that are not made from 
juices ``are essentially whole fruits and vegetables that have been 
processed to change the physical form of the fruit or vegetable to 
remove moisture.''
    One comment supports the inclusion of dried juice powder if 100% 
juice counts toward the FGEs but provides no data or information to 
support their recommendation.
    (Response 44) In the proposed rule (87 FR 59168 at 59185), we 
stated that we would consider concentrated vegetable and fruit purees 
and pastes to be vegetables and fruits for the purpose of calculating 
FGEs because these products are essentially whole vegetables and fruits 
that have been processed to change the physical form of the vegetable 
to remove moisture. We did not include vegetable and fruit powders for 
the purpose of calculating FGEs because of the potential for these 
products to be produced or used in a way that modifies the vegetable or 
fruit to an extent that removes some essential characteristics that are 
beneficial when consuming the whole vegetable or fruit, which could 
impact nutrient content. However, we asked for comment regarding 
whether vegetable and fruit powders should be included for the purposes 
of FGE calculations, and in particular, any 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. Comments to the proposed rule describe methods of 
vegetable and fruit powder production which are essentially only 
changes to the form and removal of moisture, and thus are similar to 
the production of purees and pastes. Information provided in the 
comments shows that the nutrient content of dried and ground powders is 
similar to the nutrient content of whole, fresh (or dried) varieties of 
vegetables and fruits. Comments did not provide any information about 
the processing of powders made from juices or the nutritional 
composition of powders made from juices.
    We disagree that labeling foods with vegetable or fruit powders as 
``healthy'' will send the ``wrong message'' to consumers. Foods that 
qualify for the ``healthy'' claim through the use of vegetable and 
fruit powders, including processed foods, will meet the minimum FGE 
requirements of either vegetables or fruits and will not exceed the NTL 
amounts. Therefore, foods that contain vegetable and fruit powders and 
bear the ``healthy'' claim will be nutrient-dense foods. Nutrient-dense 
whole vegetable and fruits in powdered form, or products that contain 
them, can also displace other ingredients or foods in the diet that are 
not nutrient-dense.
    For this reason, we conclude that vegetable and fruit powders that 
are produced by drying whole vegetables and fruits and grinding into 
powder form may be considered in calculation of the vegetable and fruit 
FGEs. We are aware that some powders made from 100% juice could be less 
nutrient dense, such as juice powders made with carrier agents or 
drying aids like maltodextrins (see Food Labeling; Declaration of 
Ingredients; Common or Usual Name for Nonstandardized Foods; Diluted 
Juice Beverages Final Rule (58 FR 2897 at 2917, January 6, 1993)). 
Therefore, powders made through methods with ingredients that are added 
or taken away, such as powders made from 100% juice or juice 
concentrate with the addition of maltodextrin, may not be considered in 
the calculation of vegetable and fruit FGEs. We also address powders of 
protein products, such as chickpea powders or legume powders, in 
Response 37. We state that those powders can be included in FGE 
calculations provided that the powders are essentially the dried/
dehydrated and ground forms of the original, whole food. These specific 
foods (beans, peas, lentils, soy, etc.) can also be considered under 
the vegetable group as vegetable powders.
10. Other Comments on Food Groups
    (Comment 45) Some comments discuss the health benefits associated 
with plant-based foods marketed as alternatives for other types of 
foods and recommend that FDA create a separate food group for such 
plant-based foods and beverages.
    (Response 45) There are a number of plant-based foods marketed as 
alternatives for other types of foods, e.g., soy-based milk 
alternatives or bean-based patties marketed as hamburger alternatives. 
As discussed in the section V.C.6 (``FGE for Dairy''), plant-based milk 
alternatives are subject to the criteria for the dairy food group. 
Other plant-based alternatives to animal-derived foods, though, vary 
widely in scope, and are not all similar in content, use, or nutrition. 
These plant-based alternatives to animal-derived food products are 
being modeled after many different types of animal-derived foods, 
including hamburgers, chicken nuggets, hot dogs, ground beef, or fish. 
The components of plant-based alternatives to animal-derived foods are 
broad and range from vegetables and fruits, to grains, and to other 
protein sources, such as beans and nuts. Because of the wide variation 
among products, it would not be appropriate to consider all plant-based 
foods marketed as alternatives for other types of food under the same 
criteria. These products should be considered based on the criteria for 
their individual ingredients. For example, plant-based alternatives to 
animal-derived foods that are primarily bean-based would be considered 
under the protein foods or vegetable food groups. Plant-based 
alternatives to animal-derived food products also could be considered 
under the criteria for the categories of combination foods if the 
products meet the requirements (e.g., a plant-based patty made of beans 
and grain ingredients that meets the ``healthy'' criteria for a mixed 
product). Therefore, we do not agree that a separate food group with a 
different set of criteria should be created for all plant-based foods 
and beverages marketed as alternatives to other types of food. This 
approach would be inconsistent with the Dietary Guidelines, 2020-2025, 
which does not have a separate food group for such plant-based foods 
and beverages. We are also aware of ongoing efforts in the innovation 
of meat-alternative products with novel protein ingredients from a 
variety of sources beyond plant-based

[[Page 106090]]

proteins. Novel ingredients derived from alternative sources, like 
mycoprotein and algae, may not fit into the categories of food groups 
established by the Dietary Guidelines. As efforts toward innovation 
move forward, we intend to monitor the marketplace and will address 
issues related to use of ``healthy'' on such products in the future, if 
necessary.
    (Comment 46) One comment recommends adding food groups to 
encourage, instead of NTE, which, according to the comment, would 
include groups that have nutritional value, for which current intakes 
are minimal, or that are linked to decreased chronic disease risk. The 
comment mentions fruits, vegetables, whole grains, and the subgroup 
beans, peas, and lentils as candidates for the food groups to 
encourage. The comment asserts that food groups and subgroups to which 
``automatic healthy status'' has been granted should be given a special 
designation, beyond ``healthy,'' ``to distinguish them from foods that 
were not granted automatic status and to emphasize their prioritization 
in healthy dietary patterns.''
    (Response 46) We agree with the inclusion of food group 
requirements instead of requirements for NTE in the definition of 
``healthy,'' as further discussed in section V.D.6 (``Nutrients to 
Encourage''). As described by the Dietary Guidelines, 2020-2025, a 
healthy dietary pattern ``consists of nutrient-dense forms of foods and 
beverages across all food groups, in recommended amounts, and within 
calorie limits.'' The criteria established for the definition may vary 
for individual foods from different food groups and there are foods 
which fall under the rule's single-ingredient exemption (see Response 
9). However, all foods that are able to bear the ``healthy'' claim are 
foods that are particularly useful in helping consumers to create 
healthy dietary patterns, which is the purpose of the claim. Therefore, 
we disagree that certain foods that qualify for the claim should be 
given any special designations above other qualifying foods.
    (Comment 47) One comment notes that the proposed rule does not 
include provisions for communicating how many servings or FGEs of 
fruits, vegetables, dairy, protein foods, or grains to incorporate into 
a daily pattern, and does not include a mention of staying within 
caloric requirements, both of which are recommendations of the Dietary 
Guidelines. The comment provides that, even if an individual were to 
only purchase and consume foods labeled ``healthy,'' they may not 
achieve a healthy pattern if these foods are not consumed in the 
appropriate portions for each food group and within calorie limits. The 
comment suggests that additional on-pack communications, in addition to 
the term ``healthy,'' could help consumers identify how these foods fit 
into a healthy pattern.
    (Response 47) The purpose of a ``healthy'' claim is to serve as a 
quick signal to highlight foods that, based on their nutrient levels, 
are particularly useful in building healthy dietary patterns. While we 
agree that consumer education is an important part of implementing the 
``healthy'' final rule, we have determined that it would not be 
appropriate to require educational information about the ``healthy'' 
claim or how to achieve healthy dietary patterns on food labels due to 
the limited space available and other label requirements. Information 
and education on healthy dietary patterns are readily available to 
consumers through various resources, including the Dietary Guidelines 
and related resources, such as the MyPlate education initiative at 
MyPlate.gov. Further, we plan to undertake consumer education efforts 
related to the ``healthy'' claim, which could include highlighting the 
importance of staying within daily calorie limit recommendations and 
choosing a variety of nutrient-dense foods within and across different 
food groups and subgroups--two concepts that are an integral part of 
the Dietary Guidelines, 2020-2025. Additionally, the Nutrition Facts 
label includes information about how certain nutrients fit into the 
total daily diet. For these reasons, we decline to require additional 
information on labels about ``healthy'' and healthy dietary patterns, 
although manufacturers are free to include additional truthful and non-
misleading information voluntarily.
    (Comment 48) Some comments note that the Dietary Guidelines, 2020-
2025 recognizes that dietary supplements are useful for individuals who 
cannot otherwise adequately obtain their nutrient needs or have 
different nutritional needs. The comments ask that FDA exempt dietary 
supplements from the ``healthy'' nutrient content claim requirements.
    One comment asserts that dietary supplements are outside the scope 
of the ``healthy'' implied nutrient content claim rule because, 
according to the comment, dietary supplements are, by definition, 
intended to supplement the diet and are not represented as conventional 
foods. The comment requests that if dietary supplements are not 
exempted from the ``healthy'' implied nutrient content claim criteria, 
then FDA either exercise enforcement discretion related to dietary 
supplements or establish parameters that would permit dietary 
supplements to bear the ``healthy'' claim. Another comment seeks 
clarification as to whether a dietary supplement that does not meet the 
``healthy'' claim criteria may still bear the word ``healthy'' as part 
of a claim related to a products' ability to maintain a healthy 
structure or function or an otherwise lawful dietary supplement claim.
    (Response 48) The proposed rule did not exclude dietary supplements 
from our definition (87 FR 59168 at 59176). However, as explained in 
the proposed rule, current nutrition science 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'' (id.). 
Consistent with this scientific understanding, the ``healthy'' claim is 
intended to highlight those foods that are particularly useful in 
constructing healthy dietary patterns, which includes food choices from 
across the different food groups, and we have included FGE requirements 
to update the claim definition to focus on such foods. Because this is 
the intent of the claim, we decline to exempt dietary supplements from 
the ``healthy'' criteria. However, dietary supplements may bear 
nutrient content claims, including ``healthy,'' if they meet applicable 
criteria. Under some circumstances, a dietary supplement product may 
use the term ``healthy'' as part of a structure/function claim, without 
being subject to the requirements of the ``healthy'' nutrient content 
claim (see Response 123).
    (Comment 49) Some comments request that medical foods and foods for 
special dietary use (FSDU) be exempted from the requirements of the 
``healthy'' claim. One comment states that, historically, both medical 
foods and FSDU have not been subject to the ``healthy'' claim criteria. 
According to the comment, medical foods are exempt from nutrient 
content claim requirements in Sec.  101.13(q)(4)(ii). The comment also 
mentions that Sec.  101.65(b)(6) specifically exempts claims for foods 
for special dietary use from implied nutrient content claim 
requirements when the claim identifies the special diet of which the 
food is intended to be a part; the comment asks FDA to maintain this 
exemption. The comment provides that medical foods

[[Page 106091]]

and FSDUs are not intended as conventional foods for use as part of a 
healthy dietary pattern, but instead, are intended to supplement the 
diet or meet specific nutrition requirements in specific populations. 
The comment asserts that medical foods and FSDUs should thus not be 
subject to the ``healthy'' claim criteria but instead should be allowed 
to use the term ``healthy'' in a nutritional context, provided that the 
claim is not otherwise false and misleading.
    (Response 49) Medical foods, as defined by section 5 of the Orphan 
Drug Act (21 U.S.C. 360ee(b)(3)), are exempt from nutrient content 
claim regulations and therefore not subject to this rule (Sec.  
101.13(q)(4)(ii)). Our regulations also exempt certain label statements 
from FDA nutrient content claim requirements under Sec.  101.13, and 
this rule does not alter these exemptions. For example, a label 
statement on a food that complies with a specific provision of 21 CFR 
part 105 solely to note that a product has special dietary usefulness 
relative to a physical, physiological, pathological, or other 
condition, where the claim identifies the special diet of which the 
food is intended to be a part, is exempt from the requirements in Sec.  
101.13 (Sec.  101.65(b)(6)). However, FDA regulations do not include a 
general exemption from applicable nutrient content claim labeling 
requirements for all foods for special dietary uses. Therefore, foods 
for special dietary uses are subject to the rule if manufacturers 
choose to include a ``healthy'' nutrient content claim on a label, 
unless they meet a specific exemption from the requirements of Sec.  
101.13. It would be inconsistent with current nutrition science and 
dietary recommendations on building healthy dietary patterns for a food 
for a special dietary use that does not meet the requirements of the 
``healthy'' claim to bear such claim in a label statement not subject 
to an exemption.

D. Nutrients to Limit

1. General Comments
    (Comment 50) Many comments express general support for having NTL 
as part of the ``healthy'' framework. These comments assert that 
nutrient limits combined with FGE requirements better reflect the 
overall nutrient content of a food, including how nutrients may work 
together to help build a healthy dietary pattern across different food 
groups and subgroups, and that the rule's framework is therefore more 
consistent with the Dietary Guidelines than the original definition. 
However, some comments suggest that the rule's limits for single 
``avoidance nutrients'' contradicts the approach of relying on food 
groups as a replacement for single favorable nutrients. Other comments 
acknowledge that chemically altered and highly processed foods high in 
sugar, sodium, and saturated fats should not be considered ``healthy'' 
due to their association with increased risks related to obesity and 
diet-related chronic diseases.
    (Response 50) We agree that having limits for saturated fat, added 
sugars, and sodium as part of the ``healthy'' claim criteria is 
supported by current nutrition science and Dietary Guideline 
recommendations. Current intake of saturated fat, sodium, and added 
sugars exceed recommended amounts for a majority of people in the 
United States. The Dietary Guidelines, 2020-2025 includes four over-
arching guidelines, including: (1) a guideline to focus on meeting food 
group needs with nutrient-dense foods and beverages, while staying 
within calorie limits (where nutrient-dense foods and beverages are 
described as containing vitamins, minerals, and other health-promoting 
compounds and containing little added sugars, saturated fat, and 
sodium) and (2) a guideline to limit foods and beverages higher in 
saturated fat, sodium, and added sugars. Therefore, the updated 
``healthy'' framework, consisting of minimum requirements for food 
groups as well as limits for saturated fat, sodium, and added sugars, 
is consistent with current nutrition science and key recommendations in 
the Dietary Guidelines, 2020-2025.
    We disagree that having limits for saturated fat, added sugars, and 
sodium as part of the ``healthy'' criteria contradicts having minimum 
requirements for food groups (i.e., FGE criteria) as a replacement for 
minimum requirements for individual beneficial nutrients. Food group 
requirements better reflect the array of nutrients that are contained 
in a food rather than one individual beneficial nutrient in isolation. 
Including limits for saturated fat, sodium, and added sugars, as well 
as food group criteria, in the framework for the updated ``healthy'' 
definition better characterizes the overall nutrient content of foods, 
and as mentioned is consistent with current nutrition science and the 
Dietary Guidelines, 2020-2025. For further discussion of these topics, 
see section V.C (``Food Group Equivalents'') and section V.D.6 
(``Nutrients to Encourage'').
    (Comment 51) Some comments support the different limits for 
saturated fat, sodium, and added sugars, or recommend limits that are 
more restrictive, noting that intakes of these nutrients are associated 
with adverse health outcomes and that for a majority of Americans, 
intakes of these nutrients exceed recommended amounts. However, many 
comments raise concerns that the proposed limits are too restrictive. 
For example, some comments assert that the proposed limits on saturated 
fat, sodium, and added sugars would ``arbitrarily'' disqualify many 
foods from using the ``healthy'' claim. Some comments contend that the 
proposed limits are so low that, besides whole foods or single 
ingredient foods or commodity foods, few products would meet the 
proposed criteria. For example, some comments note that healthier 
packaged foods and prepared foods often used by consumers would be 
excluded from bearing a ``healthy'' claim due to their ``judicious'' 
amounts of saturated fat, sodium, and added sugars. Another comment 
argues that the proposed criteria would force manufacturers of meals 
and main dishes that currently qualify for ``healthy'' to drastically 
reformulate their products.
    (Response 51) Based on data and information received in comments, 
current nutrition science, and the Dietary Guidelines, 2020-2025, and 
supported by our review of the products available in the marketplace 
(Ref. 2), we have made adjustments to some requirements, including to 
some of the NTL criteria, which result in more nutrient-dense foods 
that are recommended by the Dietary Guidelines, 2020-2025 being able to 
qualify for the ``healthy'' claim. Those adjustments are described in 
the following sections on saturated fat, sodium, and added sugars.
    (Comment 52) Some comments support adjusting NTL based on food 
groups and subgroups, asserting that ``some degree of variation by food 
group or subgroup is necessary to account for the intrinsic differences 
in nutrient content of different food groups and each food group's 
contribution to a healthy diet.'' One comment supports the proposed 
approach to consider characteristics of the different food groups 
instead of a ``one-size-fits-all algorithm'' for updating the 
``healthy'' definition, stating that the proposed approach is 
consistent with the principles underpinning the Dietary Guidelines that 
promote choosing healthy foods from different food groups, which work 
together synergistically within healthy eating patterns. In contrast, 
other comments argue that criteria should vary based on RACC size, 
rather than by food groups, to account for the range of RACC sizes in 
the individual/mixed foods category and their contribution to a dietary

[[Page 106092]]

pattern, arguing that there is little variation in the proposed limits 
based on food groups (e.g., 0-5% DV for added sugars across food 
groups), but considerable variation in RACC sizes in some food groups 
(e.g., 5 g to 110 g in the grains food group). Other comments support 
having different criteria (e.g., for NTL and food group contributions) 
for products with smaller RACCs. The comments note that small RACC 
foods contribute meaningfully to the diet, but, in many cases, the 
proposed food group requirements are not mathematically possible for 
smaller RACC individual/mixed foods because the RACC size is smaller 
than the minimum FGE requirement.
    (Response 52) We agree that taking into consideration the 
characteristics of the different food groups, rather than using a 
``one-size-fits-all'' approach, aligns with the framework of the 
Dietary Guidelines, 2020-2025 and its emphasis that healthy dietary 
patterns are formed by choosing nutrient-dense foods across different 
food groups, which vary in the nutrients they provide and can work 
together to improve health. Different food groups consist of foods that 
vary in their nutrient content and setting the same limit for all food 
groups could result in foods with unnecessary excess saturated fat, 
sodium, or added sugars being able to bear the ``healthy'' claim or 
result in the unnecessary addition of NTL (e.g., saturated fat or added 
sugars) to products in some food groups. For example, increasing the 
saturated fat limit across all food groups could result in the 
unnecessary addition of saturated fat for products in food groups such 
as vegetables, which are generally not sources of saturated fat, or 
result in the addition of added sugars to fruit products, which are 
generally already naturally sweet.
    Therefore, we have maintained the proposed approach of adjusting 
NTLs across food groups and subgroups for individual foods (Sec.  
101.65(d)(3)(iii)) based on considerations such as different nutrient 
profiles of the different food groups and subgroups; the Dietary 
Guidelines, 2020-2025 recommendations for different food groups (e.g., 
consuming fat-free and low-fat dairy) and for saturated fat, sodium, 
and added sugars; and current intakes of different food groups/
subgroups and NTL; and our marketplace review of nutrient-dense foods 
(Ref. 2). We have, however, modified the NTL criteria for combination 
foods (i.e., mixed products, main dishes, and meals) so that the limits 
for saturated fat, added sugars, and sodium are streamlined and are not 
dependent on the food groups that make up the combination foods (Sec.  
101.65(d)(3)(iii), (iv) and (v)) (as further discussed in section V.E 
(``Combination Foods''). We also have included criteria specifically 
for foods with smaller RACCs (<=50 g) (Sec.  101.65(d)(3)(iii)) based 
on comments to the proposed rule that demonstrate that some nutrient-
dense foods with smaller RACCs are not able to qualify based on the 
proposed criteria, which were also supported by our marketplace review 
of nutrient-dense foods across different food groups and categories 
(Ref. 2). The changes to the NTL criteria for individual foods, as well 
as the rationale for those changes, are discussed below in the 
individual NTL sections for saturated fat, sodium, and added sugars.
    (Comment 53) Some comments support considering the ``food matrix'' 
(e.g., nutrient and non-nutrient components of foods, as well as 
physical structure and form) as part of the ``healthy'' definition, and 
say that, without taking the food matrix into consideration, the 
proposed NTL could discourage the consumption of certain foods that 
contain beneficial nutrients but do not qualify for the claim (e.g., 
full-fat dairy).
    (Response 53) The description of nutrient-dense foods in the 
Dietary Guidelines, 2020-2025 (e.g., containing little or no added 
sugars, saturated fat, and sodium) does not change based on food matrix 
components such as physical structure and food form. Therefore, while 
we do adjust NTL based on unique considerations for the different food 
groups, including some components of the food matrix (such as overall 
nutrient profile), we decline to adjust NTL criteria based on other 
components of the food matrix such as physical structure, food form, 
and non-nutrient components because they do not characterize the 
nutrient levels of a food.
    (Comment 54) Some comments believe that the approach used for 
calculating the criteria for NTL should be the same approach used for 
calculating FGE criteria. For example, some comments argue that the 
criteria for the NTL, such as added sugars, should be calculated by 
dividing the DV by four eating occasions--analogous to the approach 
used for calculating FGE criteria--arguing that there is more room for 
intake of added sugars, for example, in the daily diet (i.e., without 
reaching the daily limit of 50 g for added sugars) than what would 
result with the proposed limits.
    (Response 54) We decline to use the same approach for setting NTL 
as for calculating FGE criteria. FGE requirements are the minimum 
amounts of a food from a particular recommended food group that must be 
contained in a product for it to bear the ``healthy'' claim, and they 
are intended to help consumers identify foods that can help them reach 
recommendations for food groups to meet nutritional needs.
    In contrast to FGE criteria, NTL criteria are the maximum amounts 
of saturated fat, added sugars, and sodium, that foods which bear the 
``healthy'' claim can contain, based on recommendations to limit intake 
of these nutrients. For the NTL, the goal is to stay below, rather than 
achieve, the limit in order to avoid excess intake of saturated fat, 
added sugars, and sodium. Consumers eat a variety of foods throughout 
the day. This may include multiple foods, which may or may not meet the 
``healthy'' criteria, at different eating occasions that provide 
saturated fat, added sugars, and sodium. Foods that do not qualify for 
the ``healthy'' claim that are consumed throughout the day also serve 
as sources of saturated fat, sodium, and added sugars, and may contain 
higher amounts of these nutrients (e.g., if they do not meet the 
``healthy'' NTL criteria). Consequently, it is not appropriate to 
calculate the baseline amounts for the NTL using the assumption that 
all foods consumed in a day are foods that qualify for ``healthy,'' and 
it is not appropriate to use the same approach for calculating the 
maximum amount of added sugars, saturated fat, or sodium as is used for 
calculating the minimum amount of FGEs (e.g., dividing the DV by four) 
in order for a food to qualify for ``healthy.'' This approach would be 
unlikely to help consumers identify foods that are particularly useful 
for building a healthy dietary pattern recommended by the Dietary 
Guidelines, 2020-2025, and could result in consumers exceeding the 
recommended daily limits for these NTL. We therefore decline to change 
the approach for calculating the baseline amounts for the NTL (e.g., by 
dividing the DVs for the NTL by four eating occasions) as suggested in 
the comments. We have, however, modified the proposed adjustments for 
NTL for some food groups and discuss these modifications in the 
saturated fat, sodium, and added sugars sections below.
    (Comment 55) Some comments encourage FDA to set consistent limits 
for saturated fat, added sugars, and sodium (i.e., the same percent DV 
limit for all three nutrients). For example, one comment suggests that 
the proposed baseline limits do not reflect the definition of nutrient 
density in the

[[Page 106093]]

Dietary Guidelines where all three nutrients are ``equally addressed.'' 
The comment suggests that consumers could interpret a higher limit for 
one nutrient as indicating that the one nutrient is less of a public 
health concern and offered alternative approaches for consideration, 
such as <=5% DV for saturated fat, added sugars, and sodium; 8% DV for 
saturated fat, added sugars, and sodium; or 10% DV for saturated fat, 
added sugars, and sodium.
    (Response 55) While we agree that the concepts of limiting 
saturated fat, sodium, and added sugars are all part of the definition 
of nutrient-dense foods in the Dietary Guidelines, we disagree that the 
definition implies that the limits for saturated fat, sodium, and added 
sugars must be the same in a nutrient-dense food. There are many 
factors that we considered when determining the limits for saturated 
fat, added sugars, and sodium, such as dietary recommendations and 
current scientific evidence for each, intake of each in the United 
States, inherent amounts of each in different foods, their respective 
functions in foods, and our marketplace review of nutrient-dense foods 
in the food supply (Ref. 2). These factors vary depending on the 
nutrient and the food group.
    In setting the criteria for NTL, we proposed baseline values for 
each nutrient and 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 result in the 
exclusion of foods that provide important nutrients and that are 
recommended by the Dietary Guidelines. However, increasing the 
saturated fat limit across all food groups could result in the 
unnecessary addition of saturated fat for foods in food groups such as 
vegetables, which are generally not sources of saturated fat. 
Therefore, we decline to use the same percentages to set the saturated 
fat, added sugars, and sodium limits. See below for further discussion 
of the individual limits that we have determined for saturated fat, 
added sugars, and sodium.
2. Saturated Fat
    (Comment 56) Several comments express support for the proposed 
limits on saturated fat, including the baseline of <=5% of the DV per 
RACC and proposed adjustments for different food groups (i.e., <=10% of 
the DV per RACC for dairy products, game meats, seafood, and eggs). The 
comments support aligning the baseline level with the existing ``low in 
saturated fat'' nutrient content claim, and also support adjusting the 
limits for certain food groups to allow for naturally-occurring 
saturated fat in nutrient-dense foods recommended by the Dietary 
Guidelines, 2020-2025 (e.g., low-fat dairy products, lean proteins, 
eggs, nuts, seeds, seafood, and certain oils), while ``limiting the 
addition of saturated fats to other recommended foods, such as frozen 
vegetables in a butter sauce.'' In contrast, some comments express 
concern with the proposed saturated fat limits for individual foods of 
<=5%, <=10%, and <=20% DV (depending on food group), asserting that the 
proposed saturated fat criteria are too strict. Some comments support 
the following alternative limits which they assert are largely in 
agreement with our proposed saturated fat limits but are based on RACC 
size rather than by food group: 5% DV per RACC for individual foods 
with a RACC <=30 grams, 10% DV for individual/mixed foods per RACC with 
a RACC >30 grams, 15% DV per serving for main dishes, and 20% DV per 
serving for meals. The comments argue that the alternative limits would 
allow for inclusion of foods with intrinsic saturated fat (e.g., 
protein foods, dairy, seafood, and avocado), while ``retaining a 
reasonable cap on overall saturated fat intake.'' Another comment 
states that the strict proposed saturated fat limits could deprive 
children of sufficient saturated fat, which is necessary for proper 
growth and brain development.
    (Response 56) In the proposed rule (87 FR 59168 at 59178), we 
discuss that consensus reports, as well as the Dietary Guidelines, 
2020-2025, recommend limiting saturated fat intake to no more than 10% 
of calories per day, based on risk of CVD. The baseline limit for 
saturated fat (<=5% DV per RACC) is consistent with the low saturated 
fat nutrient content claim (Sec.  101.62(c)(2)). The limits are further 
consistent with the limits for most of the individual foods in the 
original definition for ``healthy,'' and our marketplace review of 
nutrient-dense foods (Ref. 2), as well as comments that we received to 
the proposed rule, which did not suggest that the proposed saturated 
fat limits overall were too restrictive. As further discussed in 
Response 52, we have maintained the approach of adjusting limits for 
saturated fat, sodium, and added sugars for individual foods based on 
considerations for the different food groups and subgroups. Using a 
baseline limit of <=5% DV for individual foods and adjusting the limit 
(e.g., increasing the limit to <=10% DV for some food groups and 
subgroups (e.g., dairy) results in a variety of nutrient-dense foods 
recommended by the Dietary Guidelines, 2020-2025 across food groups 
being able to qualify for the ``healthy'' claim, including those with 
some inherent saturated fat (e.g., low-fat dairy). As discussed in 
Response 52, having the same saturated fat limit across different food 
groups could result in foods with unnecessary excess saturated fat 
being able to bear the ``healthy'' claim or result in the unnecessary 
addition of saturated fat to products in some food groups that are 
generally not sources of saturated fat (e.g., fruits and vegetables). 
Therefore, we decline to change the baseline limit of <=5% DV for 
saturated fat for individual foods, and we decline to adjust the limit 
based solely on RACC size for individual foods without incorporating 
food group adjustments. We have, however, adjusted the saturated fat 
criteria for some food groups and subgroups such that more nutrient-
dense foods encouraged by the Dietary Guidelines, 2020-2025 that 
contain inherent or intrinsic saturated fat will now qualify for the 
claim, as discussed below. We have also modified the saturated fat 
limits for combination foods (i.e., mixed products, main dishes, and 
meals) so that the limits are streamlined and are not dependent on the 
food groups that make up the combination foods, as further discussed in 
section V.E (``Combination Foods''). In addition, we have modified the 
proposed criteria to include different criteria for smaller RACC foods, 
described in detail in Response 8. Categories based on RACC size are 
also incorporated in the criteria for main dishes and meals (weighing 
at least 6 oz and 10 oz per labeled serving, respectively).
    Further, we disagree that the saturated fat limits for the 
``healthy'' claim would deprive children of sufficient saturated fat 
for proper growth and development, as current saturated fat intakes in 
this population exceed recommendations. For example, data from the 
Dietary Guidelines, 2020-2025 demonstrate that 82-88% of children (ages 
2-13 years) in the United States exceed the recommended daily limit for 
saturated fat.
    (Comment 57) Some comments agree with the proposal to limit 
saturated fat in general but express concern regarding the higher limit 
for dairy, game meats, eggs, oils and oil-based spreads and

[[Page 106094]]

dressings, and/or seafood. For example, some comments express concern 
that higher limits are allowed for foods that represent high sources of 
saturated fat in the diet, such as dairy and meat.
    (Response 57) The proposed rule discusses our rationale for the 
proposed adjustments to the baseline saturated fat limit across the 
different food groups and subgroups (87 FR 59168 at 59178). Generally, 
adjustments were made based on specific considerations of the different 
food groups and subgroups, as further discussed in Response 52, to 
ensure that nutrient-dense foods across all food groups and subgroups 
could qualify for the ``healthy'' claim. This approach aligns with the 
Dietary Guidelines, 2020-2025 approach for healthy dietary patterns, 
i.e., incorporating a variety of nutrient-dense foods across all of the 
food groups and subgroups (Ref. 1). For example, the Dietary 
Guidelines, 2020-2025 discusses that dairy is one of the core elements 
of a healthy dietary pattern and states that most individuals would 
benefit by increasing intake of dairy in fat-free or low-fat forms, 
whether from milk (including lactose-free milk), yogurt, and cheese, or 
from fortified soy beverages or soy yogurt. The Dietary Guidelines, 
2020-2025 also identifies protein foods, including lean meats, poultry, 
eggs, and seafood, as one of the core elements of a healthy dietary 
pattern. When selecting protein foods, the Dietary Guidelines, 2020-
2025 recommends shifting to nutrient-dense options, specifically lean 
and options that are low in saturated fat and shifting to add variety 
to the intake of protein foods. The Healthy U.S.-Style Dietary Pattern, 
as an example, includes daily amounts of lean protein and fat-free or 
low-fat dairy, because of the nutrients that these food groups provide 
(Ref. 1). Similarly, the adjustments to the saturated fat limits result 
in nutrient-dense forms of protein foods and dairy, for example, 
qualifying for the claim, thereby including a variety of foods that 
provide important nutrients to the diet while also limiting the amount 
of saturated fat that these foods contribute to the overall daily 
intake of saturated fat. These saturated fat criteria can help 
consumers identify products that can help them make shifts within the 
protein and dairy food groups. For example, one suggested shift in the 
Dietary Guidelines, 2020-2025 is ``[w]hen cooking and purchasing meals, 
select lean meat and lower fat cheese in place of high-fat meats and 
regular cheese . . .'' (Ref. 1).
    The adjustments in the saturated fat criteria are consistent with 
the Dietary Guidelines, 2020-2025. For example, for dairy, the 
saturated fat limit of <=10% DV per RACC (or per 50 g for RACCs <=50 g 
or <=3 Tbsp) will result in fat-free and low-fat dairy products 
qualifying to bear the claim, which are more nutrient-dense forms of 
dairy recommended by the Dietary Guidelines, 2020-2025, but not dairy 
products with higher amounts of saturated fat (e.g., 2% or full-fat 
milk). Fat-free and low-fat dairy products provide the same nutrients, 
but contain less saturated fat, than higher fat options such as 2% and 
full-fat milk and cheese. The saturated fat criteria will limit the 
contributions of qualifying foods to daily saturated fat intake, while 
still resulting in a variety of nutrient-dense forms across food 
groups, including dairy, game meats, eggs, seafood, and oils and oil-
based spreads and dressings being able to meet the ``healthy'' 
definition, consistent with the Dietary Guidelines, 2020-2025. 
Therefore, we are finalizing the proposed saturated fat limit of <=10% 
DV for game meats and eggs (see section V.D.5 (``Nutrients Not 
Included'') for discussion of comments on eggs and dietary cholesterol) 
and provide further discussion below of comments on nuts and seeds, soy 
products, seafood, dairy, and for oils and oil-based dressings and 
spreads.
    (Comment 58) Some comments raise concerns that the saturated fat 
limits are inconsistent across different food groups and subgroups, 
asserting that plant-based foods, such as those in the beans, peas, 
lentils, and soy products subgroup, should have at least the same 
saturated fat limit (i.e., <=10% DV instead of <=5% DV), or a higher 
limit, than animal-based foods on the grounds that: plant-based foods 
have beneficial nutrients that are lacking in animal-based foods (e.g., 
dietary fiber); certain plant-based products, such as some soy-based 
foods, ``have a healthier fat profile overall'' (e.g., higher amounts 
of unsaturated fats) than animal-based foods; plant-based foods also 
provide ``important nutrients,'' which is used as a basis in the 
proposed rule for animal-based foods having a higher saturated fat 
limit; and the reasons for the different saturated fat limits for 
animal- and plant-based foods are not consistent with nutrition science 
or Federal dietary recommendations. Some comments agree with the 
rationale in the proposed rule that many foods in the beans, peas, 
lentils, and soy products group are generally lower in saturated fat; 
however, the comments point out that some foods do contain saturated 
fat naturally. For example, some comments point out that soybeans 
contain higher amounts of saturated fat (2.88 g per 100 g) than most 
other legumes (except for peanuts), but their fatty acid profile is 
predominantly unsaturated fats (e.g., 60% polyunsaturated fat and 15% 
saturated fat), similar to the fatty acid profile of nuts. In 
comparison, peanuts contain 6.28 g of saturated fat per 100 g, but they 
are placed in the nuts and seeds subgroup and their saturated fat is 
excluded from the saturated fat limit. Other comments discuss certain 
soy-based products (e.g., plant-based patties, some tofu products) that 
would not be able to qualify due to their saturated fat content. 
Overall, these comments recommend: (1) excluding the naturally 
occurring saturated fat contained in soybeans from the saturated fat 
limit for soy products, similar to the nuts and seeds subgroup, because 
of their similar fatty acid profiles (i.e., predominantly unsaturated 
fats) or (2) increasing the saturated fat limit for the beans, peas, 
lentils, and soy products subgroup to <=10% DV to be consistent with 
other protein subgroups.
    (Response 58) Because the protein foods group is diverse and 
contains varying amounts of saturated fat and different nutrients, we 
proposed adjustments to the baseline saturated fat limit for some 
protein foods subgroups (proposed Sec.  101.65(d)(3)(ii)). For example, 
for game meat and seafood, the proposed saturated fat limits were 
increased from the <=5% DV per RACC baseline limit to <=10% DV per RACC 
(similar to the <2 g per RACC saturated fat limit for the ``extra 
lean'' nutrient content claim for game meat or seafood products). For 
nuts and seeds, we proposed that the saturated fat content inherent in 
nuts and seeds would not contribute to the 5% DV per RACC saturated fat 
limit for that subgroup. We explained the rationale for this exclusion. 
First, unsalted nuts and seeds are nutrient-dense foods and, while they 
contain saturated fat, they have a fat profile makeup of predominantly 
unsaturated fats. Second, scientific evidence, including the scientific 
evidence supporting multiple FDA-qualified health claims, demonstrate 
that replacing other sources of saturated fat in the diet with nuts has 
beneficial effects on risk of coronary heart disease, including nuts 
with higher saturated fat. Third, 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 (even though the saturated fat content of 
nuts is variable). And fourth, the Dietary Guidelines, 2020-2025 
recommends reducing saturated fat by substituting certain ingredients 
with

[[Page 106095]]

sources of unsaturated fats, for example using nuts and seeds in a dish 
instead of cheese.
    For beans, peas, lentils, and soy products, we proposed the 
baseline limit for saturated fat of <=5% DV per RACC because these 
foods generally have low amounts of naturally occurring saturated fat. 
We also noted that the protein foods subgroups used in the proposed 
rule were slightly different than the protein subgroups in the Dietary 
Guidelines, 2020-2025 due to consideration of animal sources of protein 
for which labeling is regulated by USDA's Food Safety and Inspection 
Service (e.g., meat and poultry products, egg products, and catfish), 
and specific variation needed in FGE requirements and NTL across 
protein foods subgroups. For example, we proposed a subgroup for game 
meats and a subgroup for eggs instead of the meats, poultry, and eggs 
subgroup from the Dietary Guidelines, 2020-2025. In addition, we 
grouped ``beans, peas, lentils and soy products'' together as a 
subgroup and ``nuts and seeds'' as another subgroup. In contrast, the 
Dietary Guidelines, 2020-2025, which categorizes foods into food groups 
and subgroups based on similar nutrient profiles of different foods, 
groups ``beans, peas, and lentils'' together as one subgroup and 
``nuts, seeds, and soy products'' as another subgroup (Ref. 1). The 
Dietary Guidelines, 2020-2025 also explains that generally foods made 
from processed soybeans (e.g., tofu, tempeh, and products made from soy 
flour) are part of the nuts, seeds, and soy products subgroup, while 
soybeans and edamame (soybean in the pod) are part of the beans, peas, 
and lentils subgroup.
    After considering the comments received on this topic and the 
Dietary Guidelines, 2020-2025 categorization of protein foods 
subgroups, which is based on groupings of protein foods with similar 
nutrient profiles, we modified the following proposed protein foods 
subgroups: ``beans, peas, lentils, and soy products'' and ``nuts and 
seeds.'' The final rule includes soy products with nuts and seeds 
(instead of with beans, peas, and lentils) in the ``nuts, seeds, and 
soy products'' subgroup and the proposed rule's subgroup of ``beans, 
peas, lentils, and soy products'' is now the ``beans, peas, and 
lentils'' subgroup in the final rule, which is in alignment with the 
Dietary Guidelines, 2020-2025 subgroups. The saturated fat that is 
naturally occurring in foods in the nuts, seeds, and soy products 
subgroup will be excluded from the saturated fat limit of <=5% DV per 
RACC (or per 50 g for RACCs <=50 g or <=3 Tbsp) for nuts, seeds, and 
soy products. The rationale for the exclusion of inherent saturated fat 
in nuts, seeds, and soy products is similar to the rationale discussed 
in the proposed rule, and above, for the exclusion of inherent 
saturated fat in nuts and seeds and is based on scientific evidence and 
the Dietary Guidelines, 2020-2025, and supported by our marketplace 
review (Ref. 2). Nuts, seeds, and soybeans (from which soy products are 
derived) generally have a fatty acid profile that is predominantly 
unsaturated fats, and there are multiple health claims based on 
scientific evidence supporting the beneficial relationship of fatty 
acids contained in these foods (e.g., substitution of unsaturated fats 
for saturated fats) and/or these foods (e.g., nuts, including nuts with 
relatively higher amounts of saturated fat) and reduced risk of 
coronary heart disease. Moreover, the Dietary Guidelines, 2020-2025 
does not differentiate between specific nuts or soy products based on 
saturated fat, whereas they do differentiate between foods in other 
food groups based on saturated fat (i.e., lean or low-fat meats and 
fat-free and low-fat dairy). In addition, the Dietary Guidelines, 2020-
2025 discusses specific strategies for making shifts to reduce 
saturated fat intake by replacing it with unsaturated fat. We note that 
even the nuts that are the highest in saturated fat have fat profiles 
that are predominantly unsaturated fat (e.g., Brazil nuts contain ~24% 
saturated fat and ~74% unsaturated fat) (Ref. 7). Our review of the 
products available in the current marketplace demonstrates that, if 
inherent saturated fat were not excluded, a majority of nut and seed 
products, without added sources of saturated fat, would not be able to 
meet the saturated fat limit even if it was increased to <=10% DV (per 
50 g due to their small RACC) (Ref. 2). Similar to nuts and seeds, 
soybeans also have fat profiles that are predominantly unsaturated fat 
(e.g., soybeans, mature seeds, raw contains ~14.5% saturated fat and 
~66% unsaturated fat) (Ref. 7), and therefore, the same rationale 
applies. However, as we do not consider coconut to be part of the nuts, 
seeds, and soy products subgroup, the inherent saturated fat in coconut 
is not excluded from the saturated fat limit. See Response 38 for 
discussion of why coconut is not considered part of the nuts, seeds, 
and soy products subgroup.
    Foods such as soybeans and edamame are considered part of the 
beans, peas, and lentils subgroup, consistent with the Dietary 
Guidelines. These foods (without added ingredients), including 
different forms, such as frozen edamame, would qualify for the 
exemption for single-ingredient foods that are encouraged by the 
Dietary Guidelines, 2020-2025. Soy products that contain other sources 
of saturated fat, for example, a soy-based vegetable patty that 
contains added vegetable oil, would be subject to the saturated fat 
limit for the nuts, seeds, and soy products subgroup; however, the 
saturated fat inherent in soybeans would not contribute to the limit. 
As discussed in the Dietary Guidelines, 2020-2025, one strategy for 
reducing intake of saturated fat from protein foods is to replace 
processed or high-fat meats with beans, peas, and lentils. Shifts such 
as these are encouraged in part because of the lower saturated fat 
content of beans, peas, and lentils. Increasing the saturated fat limit 
for individual foods in the beans, peas, and lentils subgroup (e.g., 
from <=5% DV to <=10% DV, as requested in some comments), which are 
generally lower in inherent saturated fat, would not reflect the 
recommended shifts in the Dietary Guidelines, 2020-2025 for the protein 
foods group and for lowering saturated fat intake, and could result in 
foods in this subgroup with unnecessary excess saturated fat qualifying 
to bear the ``healthy'' claim. Further, our marketplace review 
demonstrates that a number and variety of nutrient-dense foods within 
the different protein foods subgroups, including the beans, peas, and 
lentils subgroup and the nuts, seeds, and soy products subgroup, are 
able to meet the saturated fat limits for the different protein foods 
subgroups (Ref. 2). For example, nutrient-dense soy products with 
naturally occurring saturated fat, such as different types of tofu, 
meet a saturated fat limit for nuts, seeds, and soy products of <=5% 
DV, excluding the saturated fat inherent in nuts, seeds, and soybeans. 
Therefore, we decline to increase the saturated fat limit for the 
beans, peas, and lentils subgroup (see below for further discussion of 
comments on the saturated fat limit for nuts, seeds, and soy products).
    Other changes that we have made to the final rule will result in 
more flexibility for products in the beans, peas, and lentils subgroup 
to qualify for the ``healthy'' claim. As discussed earlier, we have 
expanded the exemption for raw, whole fruits and vegetables to include 
single-ingredient foods recommended by the Dietary Guidelines, 2020-
2025 in other food groups and in other forms (e.g., frozen edamame, 
unsalted roasted soybeans (soy nuts), and whole soybean flour). See 
below and Response 9 for further

[[Page 106096]]

discussion of the expanded exemption. In addition, we have modified the 
saturated fat limits for combination foods (i.e., mixed products, main 
dishes, and meals), which varied in the proposed rule depending on the 
food group components, to a consistent amount regardless of the food 
groups or subgroups contained in the mixed product, main dish, or meal 
(see section V.E (``Combination Foods'') for further discussion). This 
provides more flexibility, compared to the proposed rule, for mixed 
products (e.g., plant-based patties), main dishes, and meals made with 
components from food groups and subgroups such as fruits; vegetables; 
grains; beans, peas, and lentils; and nuts, seeds, and soy products to 
meet the saturated fat limits for ``healthy.'' The saturated fat 
inherent in nuts, seeds, and soy products would be excluded from the 
saturated fat limit for mixed products, main dishes, and meals. This 
will result in mixed products, main dishes, and meals that are made 
with nutrient-dense foods encouraged by the Dietary Guidelines, 2020-
2025 meeting the saturated fat criteria for ``healthy.'' For these 
reasons, we decline to increase the saturated fat limit for the beans, 
peas, and lentils subgroup. Further discussions of comments on nuts, 
seeds, and soy products, and on oils are below, and we did not receive 
comments on saturated fat and other plant-based food groups (i.e., 
fruits, vegetables, and grains). Therefore, we are finalizing the 
proposed saturated fat limits of <=5% DV for fruits, vegetables, and 
grains.
    (Comment 59) We specifically asked for comment in the proposed rule 
on whether all nuts, regardless of saturated fat, should qualify for 
the ``healthy'' claim and whether the saturated fat content contained 
in nuts and seeds should not contribute to the saturated fat limit for 
nut and seed products. Many comments support the proposed approach--
that the saturated fat contained in nuts and seeds should not 
contribute towards the saturated fat limit for nut and seed products--
agreeing with the rationale detailed in the proposed rule. In contrast, 
one comment expresses concern with allowing foods with higher amounts 
of saturated fat, such as nuts, to qualify because of the Dietary 
Guidelines daily limit for saturated fat of 10% of calories. The 
comment requests that further education be done for products containing 
nuts and seeds, i.e., language paired with a healthy icon label to help 
consumers understand healthy dietary patterns and saturated fat 
(``certain ``healthy'' nuts should be consumed in moderation due to 
their higher saturated fat content''). Another comment encourages FDA 
to eliminate the exemption for saturated fat from nuts, noting that the 
Dietary Guidelines, 2020-2025 does not make reference to source of 
saturated fat with the recommendation to limit saturated fat intake, 
and that eliminating the exemption would encourage consumers to limit 
the consumption of nuts that are high in saturated fat. The comment 
uses the example that there are several dairy products that meet the 
current requirement of 1 g of saturated fat per RACC and serving, and 
that these current requirements that exist for dairy products should 
also apply to nuts.
    (Response 59) In the preamble to the proposed rule (87 FR 59168 at 
59178-59179), we proposed that the saturated fat inherent in nuts and 
seeds would not count towards the saturated fat limit for nut and seed 
products of <=5% DV per RACC. We agree with comments supporting this 
proposal because, while nuts and seeds contain saturated fat, they have 
a fat profile makeup of predominantly monounsaturated and 
polyunsaturated fats, and numerous studies have demonstrated that 
replacing other sources of saturated fat in the diet with nuts has 
beneficial effects on CVD risk, including nuts with relatively higher 
amounts of saturated fat. FDA also has qualified health claims 
characterizing these relationships, and the Dietary Guidelines, 2020-
2025 recommends consuming nuts without differentiating among types. For 
these reasons, we are finalizing our proposal that the saturated fat 
inherent in nuts and seeds does not count towards the saturated fat 
limit for nuts and seed products.
    The Dietary Guidelines, 2020-2025 recommends reducing intake of 
saturated fat by substituting certain ingredients with sources of 
unsaturated fats, including using nuts and seeds in a dish instead of 
cheese. In addition to the multiple qualified health claims on nuts, 
there are also health claims based on the scientific evidence for the 
substitution of unsaturated fats for saturated fats. For example, as 
discussed above, we have authorized a health claim for the substitution 
of unsaturated fats for saturated fats and reduced risk of heart 
disease. The Dietary Guidelines, 2020-2025 further recommends consuming 
nuts without differentiating among types, i.e., does not specify that 
only lower saturated fat nuts should be consumed or that nuts with 
higher amounts of saturated fat should be limited. In contrast, 
different types of dairy products are encouraged in the Dietary 
Guidelines, 2020-2025 when describing strategies for the dairy group 
and when describing strategies for reducing saturated fat in general. 
For example, one strategy that is discussed is to choose fat-free or 
low-fat milk instead of 2% or whole milk. The ``healthy'' criteria for 
the dairy food group and for the nuts, seeds, and soy products subgroup 
align with the Dietary Guidelines, 2020-2025 because fat-free and low-
fat dairy, as well as nuts and seeds (without differentiating among 
types), can qualify for the ``healthy'' claim. The fatty acid profile 
of nuts, seeds, and soybeans, which consists of predominantly 
unsaturated fats, is different than the fatty acid profile of dairy, 
which consists of predominantly saturated fats, and the comment did not 
provide any rationale for why the requirements for nuts should be the 
same for dairy, particularly since nuts are included in the protein 
foods group and not the dairy food group. Based on the reasons 
described above, we disagree that the exemption for saturated fat 
inherent in nuts and seeds should be eliminated. Further, for reasons 
described above, we disagree that current saturated fat requirements 
for dairy should apply to nuts or that some nuts should not be able to 
qualify for the ``healthy'' claim. As discussed above, the final rule 
excludes naturally occurring saturated fat inherent in nuts, seeds, and 
soybeans from the saturated fat limit for the nuts, seeds, and soy 
products subgroup. Any saturated fat that is added to products in the 
nuts, seeds, and soy products subgroup that is not inherent in nuts, 
seeds, and soybeans will count towards the saturated fat limit (see 
below for further discussion of the saturated fat limit for the nuts, 
seeds, and soy products subgroup).
    We agree that consumer education is an important part of 
implementing the ``healthy'' final rule and intend to consider the 
issue of potential excess consumption of foods labeled as ``healthy'' 
in our education efforts to support implementation of the rule. 
However, we disagree that specific statements such as ``certain 
`healthy' nuts should be consumed in moderation due to their higher 
saturated fat content'' on the label accompanying the ``healthy'' claim 
is the best approach. The updated ``healthy'' definition includes 
criteria for saturated fat, sodium, and added sugars, but provides 
exclusions for inherent saturated fat contained in food groups and 
subgroups (e.g., nuts, seeds, and soy products) in which the fat 
profiles are made up of predominantly unsaturated fats. These 
exclusions are supported by scientific

[[Page 106097]]

evidence discussed above and result in nutrient-dense foods that are 
encouraged by the Dietary Guidelines, 2020-2025 qualifying for the 
claim. Because these foods can be particularly useful in building a 
healthy dietary pattern, which aligns with the purpose of the updated 
``healthy'' claim, it is not necessary to include additional language 
accompanying the ``healthy'' claim about the saturated fat content of 
nuts.
    (Comment 60) Another comment requests that FDA consider whether the 
saturated fat criterion for nuts and seeds could increase the use of 
nuts as a source of saturated fat in combination foods that may not 
have previously included nuts, which could pose issues for individuals 
with nut allergies (e.g., who may not be aware of changes to products 
to include nuts).
    (Response 60) FDA takes several measures to protect those with food 
allergies and other food hypersensitivities. These measures include 
establishing regulatory requirements (e.g., allergen labeling); 
providing guidance to the food industry, consumers, and other 
stakeholders on best ways to assess and manage allergen hazards in 
food; conducting surveillance; and taking regulatory actions when 
appropriate. For certain foods or substances that cause allergies or 
other hypersensitivity reactions, there are more specific labeling 
requirements. Under section 403(w)(1) of the FD&C Act, food labels must 
identify the food source of all major food allergens used to make the 
food. While it is possible that some manufacturers may choose to 
reformulate products in ways that increase the use of nuts to meet the 
``healthy'' criteria, FDA cannot predict whether this rule will result 
in an overall increase in the use of nuts in products that previously 
did not include them, and we do not have any evidence that there will 
be a significant change in the foods available to consumers with food 
allergies. If there are changes made to ingredients that include the 
addition of major food allergens (e.g., nuts and fish), these 
ingredients still must be declared on the food label in accordance with 
sections 403(i) and 403(w) of the FD&C Act. It is important that 
consumers with food allergies always read labels to identify foods that 
they are allergic to, which can also help them recognize any changes in 
the formulation of a product.
    (Comment 61) Some comments recommend that we increase the limit for 
saturated fat from added oils in peanut butter (<=5% of the DV for nuts 
and seeds in the protein food subgroup in proposed Sec.  
101.65(d)(3)(ii)) to make it consistent with the proposed limit for 
some of the other protein food subgroups (i.e., <=10% of the DV), 
noting that oils may sometimes be added to peanut butter for stability 
and ease of spreading. The comments highlight the nutrient content of 
nuts and seeds (e.g., sources of unsaturated fats), including peanut 
butter, and the health benefits associated with their consumption. 
Further, several comments assert that peanut butter is an economical 
way for people to consume important nutrients and protein. One comment 
states that it would be unfortunate if peanut butter were excluded from 
the final rule.
    (Response 61) As discussed above, we described the rationale for 
adjusting the saturated fat baseline limit for different protein 
subgroups in the proposed rule (87 FR 59168 at 59178-59179). For 
example, for game meats and seafood, the proposed saturated fat limit 
was increased from <=5% DV per RACC to <=10% DV per RACC (similar to 
the <2 g per RACC saturated fat limit for the ``extra lean'' nutrient 
content claim for game meat or seafood products) because using the <=5% 
DV baseline limit would prevent nutrient-dense foods in these subgroups 
from being able to bear the ``healthy'' claim due to their inherent 
saturated fat. In contrast, for the nuts and seeds subgroup, the 
proposed adjustment to the baseline saturated fat limit was to exclude 
the inherent saturated fat in nuts and seeds from counting towards the 
<=5% DV per RACC saturated fat limit. This adjustment was proposed so 
that all nuts, which contain fat profiles that are predominantly 
unsaturated fats, could qualify for the ``healthy'' claim, consistent 
with scientific evidence and the Dietary Guidelines, as described 
above.
    We agree that nut butters can be an economical way for people to 
consume protein and certain nutrients. Our review of the products 
available in the current marketplace demonstrates that many nut butters 
meet the proposed saturated fat criteria for nuts and seeds, including 
all nut butters that contain only nuts or only nuts and salt (Ref. 2). 
Therefore, we disagree that peanut butter would be unable to bear the 
``healthy'' claim with a saturated fat limit of <=5% DV (excluding the 
saturated fat inherent in nuts). As noted in some comments, oils may be 
added to some peanut butters for stability and ease of spreading. 
However, as mentioned, there are also nut butters that do not contain 
added oils. Many of the nut butters that do not meet the limit for 
saturated fat to bear the claim contain palm oil or fully hydrogenated 
vegetable oils, which have relatively higher amounts of saturated fat 
compared with other oils. Increasing the baseline saturated fat limit 
to <=10% DV, in addition to providing an exclusion for saturated fat 
inherent in nuts and seeds, could result in additional saturated fat, 
including from oils that are higher in saturated fat such as palm oil, 
in products that already contain inherent saturated fat. The Dietary 
Guidelines, 2020-2025 states that ``[t]he fat in some tropical plants, 
such as coconut oil, palm kernel oil, and palm oil, are not included in 
the oils category because they contain a higher percentage of saturated 
fat than do other oils'' (Ref. 1). Further, increasing the saturated 
fat limit to <=10% DV (which could result in additional saturated fat 
in nut butters, for example from oils with higher amounts of saturated 
fat), would not be consistent with our basis for proposing a saturated 
fat limit for 100% oils of 20% of total fat--to align with the National 
Academies (i.e., DRI macronutrient report description of dietary fats 
low in saturated fatty acids), the Dietary Guidelines, 2020-2025, and 
other labeling claims. Many nut butters, including peanut butter, are 
able to qualify for the claim with a saturated fat limit of <=5% DV 
while excluding the saturated fat inherent in nuts.
    For the reasons discussed above, we decline to further adjust the 
proposed saturated fat limit for nuts and seeds and are therefore 
finalizing the limit for the nuts, seeds, and soy products subgroup at 
<=5% DV per RACC or per 50 g for RACCs <=50 g or <=3 Tbsp, with the 
exclusion of inherent saturated fat in nuts, seeds, and soy products 
(Sec.  101.65(d)(3)(iii)).
    (Comment 62) Some comments assert that the saturated fat criteria 
for seafood are too stringent, despite seafood having a favorable fatty 
acid profile (i.e., good sources of unsaturated fats) and providing 
other important nutrients (e.g., calcium, potassium, and vitamin D). 
For example, some comments said that certain higher fat species of fish 
(e.g., king salmon and halibut) would be disqualified with a <=10% DV 
per RACC saturated fat limit, despite being high in nutrients such as 
beneficial fats. Similarly, some comments assert that certain higher 
fat fish that contain predominantly unsaturated fat, are higher in 
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) than other 
fish, and are recommended by the Dietary Guidelines, 2020-2025 would be 
excluded from bearing the ``healthy'' claim. Some comments note that 
the proposed saturated fat limit for seafood represents a regression of 
standard to pre-2016 (referring to the FDA enforcement discretion 
guidance that was issued for foods that are not low in

[[Page 106098]]

total fat but have a fat profile consisting of predominantly mono- and 
polyunsaturated fats and is discussed further in our response below). 
Another comment expresses concern regarding the proposed approach for 
allowing more ``nutrient flexibility'' for some food categories but not 
others--such as nuts and seeds, but not seafood--despite their similar 
fatty acid profiles with high mono- and polyunsaturated fat content, 
arguing that it is arbitrary and unjustified. Some comments, therefore, 
request that we either increase the saturated fat limit for seafood 
(e.g., from <=10% DV to <=15% DV), use a framework similar to our 2016 
guidance (i.e., for foods that contain amounts of combined mono- and 
polyunsaturated fats that are greater than their saturated fat amount), 
or provide an exemption for saturated fat contained in seafood, similar 
to the exemption for saturated fat contained in nuts and seeds, because 
they all have similar fatty acid profiles. Other comments request that 
we expand the exemption for raw, whole fruits and vegetable to other 
single ingredient foods, to ensure that nutrient-dense foods 
recommended by the Dietary Guidelines, 2020-2025, such as seafood, can 
qualify for the claim.
    (Response 62) As discussed in the Dietary Guidelines, 2020-2025, 
the seafood subgroup, which includes fish and shellfish, provides 
beneficial unsaturated fatty acids, such as EPA and DHA, as well as 
other important nutrients (e.g., calcium, vitamins D and 
B12, and heme iron). Despite the beneficial fatty acid and 
nutrient profiles of seafood, almost 90% of the U.S. population do not 
meet recommendations for seafood (Ref. 1). The Dietary Guidelines, 
2020-2025 encourages seafood choices that are higher in beneficial 
unsaturated fatty acids (e.g., EPA and DHA), and does not distinguish 
between seafood based on saturated fat amounts, in contrast to dairy 
and meat (i.e., fat-free or low-fat dairy, and lean or low-fat meat).
    In 2016, we issued a guidance on the use of the term ``healthy,'' 
in part to advise food manufacturers of our intent to exercise 
enforcement discretion relative to foods that are not low in total fat 
but have a fat profile makeup of predominantly mono- and 
polyunsaturated fats. We explained in the guidance that the focus of 
the most recent dietary fat recommendations has shifted away from 
limiting total fat intake to encouraging intakes of mono and 
polyunsaturated fats and that foods that use the term `healthy' on 
their labels that are not low in total fat should have a fat profile 
makeup of predominantly mono and polyunsaturated fats (i.e., sum of 
monounsaturated fats and polyunsaturated fats are greater than the 
total saturated fat content of food). We advised manufacturers that we 
intended to exercise enforcement discretion with respect to the 
requirement at that time that any food bearing the nutrient content 
claim ``healthy'' meet the low fat criterion (Sec.  101.65(d)(2)(i)), 
provided that the amounts of monounsaturated and polyunsaturated fats 
in the product constituted the majority of the fat content, if certain 
conditions were met (Notice of Availability for a Final Guidance ``Use 
of the Term `Healthy' in the Labeling of Human Food Products: Guidance 
for Industry'' September 28, 2016, 81 FR 66527). This exercise of 
enforcement discretion was important because the fat that is contained 
in these products is mostly the types that are encouraged by current 
dietary recommendations (i.e., unsaturated fats).
    We agree with the comments recommending that we expand the proposed 
exclusion for inherent saturated fat in nuts and seeds to seafood 
because seafood has fat profiles consisting of predominantly 
unsaturated fats similar to nuts and seeds and contains EPA and DHA as 
well as other important nutrients. The final rule, therefore, excludes 
the inherent saturated fat contained in seafood from the saturated fat 
limit for the seafood subgroup in Sec.  101.65(d)(3)(iii), similar to 
the nuts, seeds, and soy products subgroup. Our marketplace review 
demonstrates that saturated fat amounts not only vary between types of 
seafood (e.g., different types of fish and shellfish), but also within 
species (e.g., different species of salmon) (Ref. 2). While single-
ingredient seafood automatically qualifies for the ``healthy'' claim 
under the single-ingredient exemption (see Response 9), a saturated fat 
limit for the seafood subgroup of <=10% DV could exclude products 
containing certain species of higher fat fish/seafood (e.g., certain 
species of salmon) that are sources of beneficial unsaturated fatty 
acids and recommended by the Dietary Guidelines, from qualifying for 
the ``healthy'' claim if the products contain other ingredients (e.g., 
sauce or seasoning). Further, the saturated fat limits for combination 
foods (i.e., mixed products, main dishes, and meals) could restrict 
rather than encourage seafood from being incorporated into combination 
foods (see section V.E (``Combinations Foods'') for further discussion 
on the saturated fat limits for combination foods). Excluding 
individual foods that contain higher fat fish that are sources of 
unsaturated fatty acids (e.g., EPA and DHA), but are not single-
ingredient products, or causing manufacturers to avoid using certain 
seafood ingredients in combination foods, is not consistent with the 
Dietary Guidelines, 2020-2025, which specifically encourages 
consumption of fish that is higher in EPA and DHA (and lower in 
methylmercury) and does not distinguish between types of seafood based 
on saturated fat amounts.
    The basis for the exclusion of inherent saturated fat in seafood is 
similar to that for the exclusion of inherent saturated fat in nuts, 
seeds, and soy products. The fatty acid profile of seafood is similar 
to nuts, seeds, and soybeans in that it is predominantly unsaturated 
fats and there is strong evidence that substituting unsaturated fats 
for saturated fat can lower the risk of CVD (for further discussion of 
this evidence, see Response 63). Further, there are health claims based 
on the evidence supporting the substitution of unsaturated fats for 
saturated fats and risk of coronary heart disease. For example, we have 
authorized a health claim for the substitution of unsaturated fats for 
saturated fats and reduced risk of heart disease. In addition, as 
previously noted, the Dietary Guidelines, 2020-2025 does not emphasize 
or differentiate between certain seafood based on saturated fat, 
whereas it does for other food groups and subgroups (i.e., lean or low-
fat meats and fat-free or low-fat dairy). Instead, the Dietary 
Guidelines, 2020-2025 encourages consumption of seafood, such as 
salmon, that is higher in the unsaturated fats EPA and DHA (and lower 
in methylmercury). Even fish with relatively higher amounts of 
saturated fat have fat profiles that are predominantly unsaturated fats 
(e.g., salmon, chinook, raw contains ~30% saturated fat and ~69% 
unsaturated fat) (Ref. 7). The Dietary Guidelines, 2020-2025 also 
discusses specific strategies for reducing saturated fat intake by 
replacing it with unsaturated fat and for adding variety to protein 
subgroup intakes--such as consuming seafood more often or replacing 
foods that are higher in saturated fat (e.g., high-fat meats or regular 
cheese) with sources of unsaturated fat. Therefore, to ensure that 
nutrient-dense seafood products with a fatty acid profile of 
predominantly unsaturated fats are not excluded from bearing the 
``healthy'' claim, we are excluding the inherent saturated fat in 
seafood from the saturated fat limit in Sec.  101.65(d)(3)(ii) for the 
seafood subgroup.

[[Page 106099]]

    In the proposed rule, we proposed an adjustment to the baseline 
saturated fat limit for seafood (i.e., increasing the baseline 
saturated fat limit from <=5% DV per RACC to <=10% DV per RACC) to be 
consistent with the saturated fat limit for the ``extra lean'' nutrient 
content claim for seafood or game meat products (Sec.  101.62(e)(4)), 
as was used in the original criteria for ``healthy,'' and because using 
the baseline saturated fat limit would prevent nutrient-dense foods in 
this food group from being able to bear the ``healthy'' claim even 
though they contain important beneficial nutrients such as unsaturated 
fatty acids (e.g., EPA and DHA) and can help consumers build a healthy 
dietary pattern as recommended by the Dietary Guidelines, 2020-2025. 
Because the inherent saturated fat in seafood will now be excluded from 
the saturated fat limit for the seafood subgroup, we have determined 
that the baseline saturated fat limit of <=5% (with the exclusion of 
inherent saturated fat in seafood), rather than the proposed limit of 
<=10% DV, will result in nutrient-dense seafood products qualifying for 
the ``healthy'' claim without resulting in the addition of unnecessary 
saturated fat to products that already contain inherent saturated fat. 
This approach is consistent with the saturated fat criteria for the 
nuts, seeds, and soy products subgroup. Moreover, the single ingredient 
exemption, discussed in Response 9, includes higher fat species of fish 
that are sources of beneficial unsaturated fatty acids such as EPA and 
DHA, among other nutrient-dense foods.
    (Comment 63) Some comments contend that few dairy foods, other than 
non-fat and low-fat, unflavored, milk and yogurt, could bear the 
``healthy'' claim despite dairy being good or excellent sources of 
three of the four nutrients of public health concern (i.e., calcium, 
vitamin D, and potassium). Some comments support having higher 
saturated fat limits for foods such as dairy, or express opposition to 
any limit on saturated fat, asserting that FDA lacks credible evidence 
that saturated fats are harmful. Some comments object to FDA's 
interpretation of the effect of saturated fat on cardiovascular health 
and obesity, arguing that full-fat dairy products have ``neutral and 
positive attributes.'' Other comments recommend that we exclude milkfat 
from the saturated fat limit for the dairy food group when it is 
inherently present in a product (such as cheese), due to emerging 
science on benefits of milkfat, arguing that full-fat and reduced-fat 
dairy products (e.g., 2% milk) should also be able to make ``healthy'' 
claims. Some comments state that all nutrition science should be 
considered, not just the science reflected in the Dietary Guidelines, 
2020-2025 and the updated Nutrition Facts label, and reference groups 
outside of the United States that have either provided exemptions for 
certain dairy products (e.g., 2% milk, whole milk, and yogurt and 
cheese if they contain certain amounts of nutrients) from front-of-pack 
labeling requirements (Health Canada) or have changed their dietary 
recommendations to include dairy at all fat levels for the general 
population (Australian Heart Foundation). Further, some comments note 
that the 2025 Dietary Guidelines Advisory Committee is addressing a 
question on food sources of saturated fat, and that future iterations 
of the Dietary Guidelines may create additional food source-specific 
guidelines on saturated fat; therefore, they argue that flexibility 
should be provided for dairy products (e.g., exempting milkfat from the 
saturated fat limit) to reduce delays in adjusting to the next Dietary 
Guidelines.
    (Response 63) In the proposed rule (87 FR 59168 at 59172), we 
described the need to update the ``healthy'' definition so the claim 
would again accurately represent levels of nutrients in a food that may 
help consumers maintain healthy dietary practices, consistent with 
current nutrition science and Federal dietary guidance, as reflected in 
the Dietary Guidelines, 2020-2025. More closely aligning the 
``healthy'' definition with the nutrition science underpinning the 
Dietary Guidelines, 2020-2025 will better inform consumers and help 
them identify foods that are particularly useful in building a healthy 
dietary pattern. The Dietary Guidelines, which are updated every 5 
years to reflect current nutrition science, are the foundation of 
Federal dietary guidance and are intended to inform policymakers when 
implementing federal policies and programs related to food, nutrition, 
and health. The Dietary Guidelines, as well as consensus reports from 
authoritative bodies, and their nutrition science underpinning, help 
FDA to shape regulations on nutrition-related claims and other 
information that is on a food label.
    When developing regulations for nutrition-related claims and 
nutrition labeling, we review and consider many sources of scientific 
evidence, information, and dietary recommendations that may be relevant 
(e.g., conclusions of other expert or international bodies), and 
findings or research that represent consensus of experts in the field 
or an entire body of scientific literature are generally more 
informative than individual studies. We have closely aligned the 
updated criteria with nutrition science underpinning federal dietary 
guidance, particularly the Dietary Guidelines, while also considering 
other sources of scientific evidence and information, for example, 
consensus reports from authoritative bodies; FDA health claims and the 
scientific evidence on which they are based; our marketplace review of 
nutrient-dense foods; public comments to the proposed rule, including 
studies and data submitted in comments; and U.S. consumption patterns 
for saturated fat, added sugars, sodium, and recommended food groups 
and subgroups.
    Nutrient-dense foods are described in the Dietary Guidelines, 2020-
2025, as providing important nutrients (e.g., vitamins and minerals), 
while providing little or no saturated fat, added sugars, and sodium 
(Ref. 1). Fat-free and low-fat dairy products are considered to be more 
nutrient-dense forms of dairy because they provide the same important 
nutrients (e.g., calcium, vitamin D, and potassium), but contain less 
saturated fat than higher fat options such as 2% and full-fat milk and 
cheese (Ref. 1). As discussed above, the Dietary Guidelines, 2020-2025 
states that it would be beneficial for most consumers to increase 
consumption of dairy in fat-free or low-fat forms and includes 
strategies to increase dairy intake, such as drinking fat-free or low-
fat milk with meals or incorporating unsweetened fat-free or low-fat 
yogurt into meals or snacks. In the proposed rule, we proposed a 
saturated fat limit for the dairy group of <=10% DV per RACC, an 
increase from the baseline saturated fat limit of <=5% DV per RACC, so 
that fat-free and low-fat dairy products--more nutrient-dense forms of 
dairy recommended by the Dietary Guidelines, 2020-2025--could meet the 
saturated fat limit. Our review of the products available in the 
marketplace, in response to these comments, demonstrates that nutrient-
dense forms of dairy, including fat-free and low-fat milk and yogurt, 
can meet the proposed <=10% DV per RACC saturated fat limit (Ref. 2). 
Our marketplace review also indicates that many cheeses currently in 
the marketplace do not meet the proposed <=10% DV per RACC saturated 
fat limit (e.g., because fat-free and low-fat cheese products make up a 
low percentage of the overall cheese market) (Ref. 2). However, the 
Dietary Guidelines, 2020-2025 emphasizes that most individuals would 
benefit by increasing intake of fat-free or low-fat

[[Page 106100]]

cheese (as well as other types of dairy such as fat-free or low-fat 
milk and yogurt), and we have determined that a saturated fat limit of 
<=10% DV per RACC or per 50 g for RACCs <=50 g or <=3 Tbsp for the 
dairy food group will help consumers identify dairy products in more 
nutrient-dense forms (i.e., fat-free and low-fat), consistent with the 
Dietary Guidelines, 2020-2025, and that these nutrient-dense dairy 
foods that qualify for the ``healthy'' claim can serve as a foundation 
for a healthy dietary pattern. Therefore, we decline to increase the 
saturated fat limit for dairy foods above <=10% DV per RACC. We 
emphasize that dairy products that exceed the saturated fat limit can 
still be part of a healthy dietary pattern and their nutritional 
attributes can be conveyed with other labeling claims or other truthful 
and non-misleading statements in labeling.
    The Dietary Guidelines, 2020-2025 provides the following 
recommendation for limiting saturated fat: ``For those 2 years and 
older, 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'' (Ref. 1). The recommended limit for 
saturated fat in the Dietary Guidelines, 2020-2025 is based on the 
totality of the scientific evidence, including rigorous systematic 
reviews, examined by the 2020 DGAC for the relationship between 
saturated fat, particularly the replacement of saturated fat with 
unsaturated fats, and cardiovascular disease and blood cholesterol. For 
example, the 2020 DGAC review found that reducing intake of saturated 
fat in adults by substituting it with unsaturated fats, particularly 
polyunsaturated fat, lowers the incidence of CVD (Ref. 8). 
Specifically, the 2020 DGAC concluded in their report that: (1) there 
was strong evidence that replacing saturated fat intake with 
polyunsaturated fatty acids reduces CHD events and CVD mortality in 
adults and (2) there was strong and consistent evidence that replacing 
saturated with unsaturated fats, particularly polyunsaturated fats, in 
the diet reduces low-density lipoprotein (LDL) cholesterol in adults. 
The 2020 DGAC report emphasizes that shifts from saturated fat to 
unsaturated fats are best within the context of a healthy dietary 
pattern, which includes higher intake of fatty fish, nuts and seeds, 
and low-fat dairy (as well as other recommended food groups) (Ref. 8).
    As discussed in detail above, the inherent saturated fat in seafood 
and in nuts, seeds, and soybeans are excluded from the saturated fat 
limits for the seafood subgroup and the nuts, seeds, and soy products 
subgroup because their fat profiles are predominantly unsaturated fats. 
Based on the evidence for unsaturated fats, particularly the 
substitution of unsaturated fats for saturated fat, there are Federal 
dietary recommendations and health claims for the substitution of 
unsaturated fats for saturated fat in the diet and for foods with fatty 
acid profiles that are predominantly unsaturated fats. Further, in 
contrast to what it does for dairy, the Dietary Guidelines, 2020-2025 
does not distinguish between or encourage different types of seafood 
based on saturated fat content, but rather encourages seafood choices 
that are higher in unsaturated fats, i.e., EPA and DHA (and lower in 
methylmercury), and also does not distinguish between or encourage 
different types of nuts, seeds, and soy products based on saturated fat 
content. In contrast to the fat profiles of nuts, seeds, and soy 
products, and seafood, which are predominantly unsaturated fat, the fat 
profiles of full-fat dairy foods are predominantly saturated fat (e.g., 
milk, whole, 3.25% milkfat, with added vitamin D contains ~67% 
saturated fat and 25% unsaturated fat; yogurt, plain, whole milk 
contains ~54% saturated fat and ~22% unsaturated fat) (Ref. 7). One of 
the characteristics of a healthy dietary pattern, as described in the 
Dietary Guidelines, 2020-2025, includes relatively higher amounts of 
low- or non-fat dairy. In addition, as mentioned previously, the 
Dietary Guidelines, 2020-2025 encourages shifts to more nutrient-dense 
forms of dairy, i.e., fat-free and low-fat dairy.
    We are aware of relatively recent studies on the effects of 
different sources of saturated fat, such as dairy. The 2020 DGAC review 
focused on types of dietary fats rather than sources; however, the 
committee recognized the growing body of research on specific fatty 
acids, sources of fats (explicitly sources of saturated fat), and the 
food matrix in their report. As noted in some comments, the 2025 DGAC 
is currently examining a question on food sources of saturated fat and 
risk of cardiovascular disease. It would be premature to speculate 
about what the findings will be from the 2025 DGAC review related to 
food sources of saturated fat, or what future iterations of the Dietary 
Guidelines might include on this topic. Further, we are unaware of 
recommendations from other U.S. Federal entities, or consensus reports 
from authoritative bodies that include recommendations for the general 
U.S. population, that encourage full-fat dairy for the general U.S. 
population.
    Based on these considerations, we decline to exempt the saturated 
fat inherent in dairy foods from the saturated fat limit for the 
``healthy'' definition. We will continue to stay abreast of research in 
this area, including any future consensus reports or recommendations 
from federal bodies, such as the Dietary Guidelines. For discussion of 
comments expressing opposition to any limit on saturated fat for the 
``healthy'' criteria, see section (a) below (basing the saturated fat 
limit on a ratio approach versus the % DV).
    (Comment 64) Some comments support the proposed saturated fat limit 
of <=20% of total fat for 100% oils, oil-based spreads, and oil-based 
dressings, asserting that this limit is consistent with what is used by 
the National Academies, grounded in the scientific literature, and 
ensures that oils, spreads, and dressings can be a part of a healthy 
dietary pattern because they are lower in saturated fat and higher in 
unsaturated fatty acids. One comment notes that FDA struck the right 
balance in determining which products should be considered ``healthy'' 
with respect to the ``oils and fats'' group. In contrast, some comments 
argue that the saturated fat limit of <=20% of total fat poses a food 
design problem for oil-based spreads. Two comments assert that 25% of 
total fat is the lower limit for saturated fat in order for spreads to 
maintain their solid nature, and that a limit of 20% of total fat would 
only allow sprays and liquid margarine products to qualify. Further, 
these comments recommend that spreads be given the option of qualifying 
as a small RACC food and qualifying based on the actual amount of 
saturated fat per serving rather than the saturated fat oil component. 
One comment notes that a saturated fat limit of 25% of total fat is 5% 
lower than most spreads in the market. Another comment recommends 
increasing the limit to 33% of total fat asserting that this would be 
consistent with the World Health Organization's (WHO) recommendations 
for total fat and saturated fat of no more than 30% of caloric intake 
and 10% of caloric intake, respectively.
    (Response 64) In the proposed rule (87 FR 59168 at 59189), we 
explained that we proposed a saturated fat limit for oils of 20% of 
total 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.'' We discussed 
in the proposed rule that a saturated fat limit of <=20% of total fat 
for the oils group is also consistent with both the percentage used in 
the National

[[Page 106101]]

Academies DRI macronutrient report to describe dietary fats low in 
saturated fatty acids (Ref. 9) and the saturated fat requirement for 
determining the type of foods, for example vegetable oils, spreads, and 
shortenings, that are eligible to bear the health claim for 
``Substitution of Saturated Fat in the Diet with Unsaturated Fatty 
Acids and Reduced Risk of Heart Disease'' (Ref. 13). Further, it aligns 
with the recommendations and strategies in the Dietary Guidelines, 
2020-2025 for the substitution of saturated fat with unsaturated fat, 
including specific shifts that are encouraged related to oils (e.g., 
using oils that are higher in unsaturated fat instead of fats high in 
saturated fat, such as butter, shortening, lard, or coconut or palm 
oils). As noted above, the Dietary Guidelines, 2020-2025 does not 
include coconut oil, palm kernel oil, or palm oil in the oils category 
because they contain a higher percentage of saturated fat compared to 
other oils.
    We agree with comments that a saturated fat limit of <=20% of total 
fat is supported by a body of scientific evidence, including evidence 
demonstrating reductions in LDL-cholesterol when plant-derived oils are 
substituted for fats or oils higher in saturated fat. We recognize that 
saturated fat is used in oil-based spreads for certain functions such 
as stability and texture. However, we disagree that 25% of total fat is 
the lower limit for saturated fat in order for oil-based spreads to 
maintain their solid nature, as our marketplace review demonstrates 
that there are oil-based spreads currently in the marketplace that 
contain saturated fat in amounts that are <=20% of total fat (Ref. 2). 
Therefore, we also disagree that a saturated fat limit of <=20% of 
total fat would only result in sprays and liquid margarine products 
qualifying. Increasing the limit for oil-based spreads, for example to 
<=25% or <=33% of total fat as requested in some comments, would result 
in use of the ``healthy'' claim on oil-based spreads with higher 
amounts of saturated fat which would be inconsistent with the claim's 
objective of helping consumers to identify products that are 
particularly useful for creating a healthy diet consistent with dietary 
recommendations. We note that the WHO recommended limits of <=30% of 
total calories from total fat and <=10% of total calories from 
saturated fat are based on percentages of total caloric intake and are 
not on a per product basis. Therefore, we disagree that the WHO 
recommendations for total fat and saturated fat as a percentage of 
total calorie intake warrant a saturated fat limit of 33% of total fat 
for oil-based spreads in this rule regarding the ``healthy'' claim.
    For the reasons discussed above, we decline to increase the 
saturated fat limit for oil-based spreads and are finalizing the 
saturated fat limit of <=20% of total fat for 100% oils, oil-based 
dressings, and oil-based spreads. While oil-based spreads are a small 
RACC food, the saturated fat limit for the oils food group, including 
100% oil, oil-based dressings, and oil-based spreads, is based on a 
percentage of total fat rather than the amount of saturated fat per 
serving, for the reasons discussed above.
a. Request for Comment on Limits Based on Ratio of Saturated Fat to 
Total Fat (Alternative Approach)
    In the preamble to the proposed rule, we explained that we were 
also considering alternatives to the proposed limits on saturated fat, 
including 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% and 35% of daily calorie intake, respectively (87 FR 
59168 at 59179). We explained that the intent of this approach would be 
to apply a single ratio across all food groups, thereby reducing the 
variation in the proposed limits, while still providing some 
flexibility for foods that supply monounsaturated and polyunsaturated 
fats (see 87 FR 59168 at 59179). We invited comment on this approach.
    (Comment 65) Some comments argue that a ratio of unsaturated fat to 
saturated fat is a more favorable approach than the proposed approach 
for saturated fat limits based on percent DV, asserting that current 
Dietary Guidelines focus ``on the type of fat, rather than the amount 
of fat or specific subtypes of fat.'' Similarly, some comments argue 
that a ratio-based approach (e.g., a ratio of saturated fat to total 
fat of <1:3.5 derived from the DVs for saturated fat and total fat) 
would ensure that foods such as fish products, which contain high 
levels of mono- and polyunsaturated fats, are able to bear the 
``healthy'' claim, as well as other foods like cooked soybeans, cooked 
edamame, dried chickpeas, and boiled or canned potatoes. In contrast, 
numerous comments express support for the current proposal of using a 
limit of saturated fat alone, and not for the alternative approach of 
using a ratio of saturated fat to total fat, reasoning that the current 
proposed approach is simpler and aligns better with the Dietary 
Guidelines, which do not focus on achieving a particular ratio of 
saturated fat. The comments argue that a ratio approach is also not 
generally used in other dietary guidance and that any type of ratio-
based approach that would place emphasis on overall fat content is not 
consistent with Federal policy recommendations and could create 
confusion for consumers. However, one comment indicates support for a 
ratio approach if the Dietary Guidelines were updated to include a 
recommended ratio of saturated to total fat. Some comments also discuss 
that an alternative approach like a ratio of saturated fat to total fat 
would be harder to understand and possibly misleading--specifically, it 
could allow manufacturers to manipulate their ratios and achieve 
``healthy'' claims on products with high saturated fat. Similarly, 
other comments express opposition to the use of a ratio for saturated 
fat to total fat on the grounds that it could encourage manipulation of 
dairy foods to decrease the ratio, it would not contribute to greater 
consumer understanding of ``healthy'' diets, and it could lead to a 
greater intake of saturated fats. In addition, one comment says that a 
ratio approach would exclude foods with small amounts of saturated fat 
(e.g., 1 gram) if those foods did not contain at least a certain amount 
of total fat (e.g., 3.5 grams).
    (Response 65) We agree that the Dietary Guidelines focus on types 
of fat, rather than the amount of total fat or specific subtypes of 
fat. However, this does not support a ratio approach for saturated fat. 
In fact, this supports the proposed approach for saturated fat as a 
percentage of the DV, as the Dietary Guidelines, 2020-2025 provides a 
recommended daily limit amount for saturated fat, but does not provide 
recommendations for specific ratio amounts (e.g., ratio of saturated 
fat to total fat or ratio of unsaturated fat to saturated fat). 
Therefore, we agree that the approach of a saturated fat limit based on 
the percent DV, and not on a ratio, is more consistent with the Dietary 
Guidelines, 2020-2025's recommended quantitative limit for saturated 
fat. We also note that removal of the total fat limit as part of the 
``healthy'' criteria also supports the shift to focus on the types of 
fat rather than total fat, as we discuss in the proposed rule (87 FR 
59168 at 59178-59179). We agree that using saturated fat limits based 
on the percent DV is simpler than using limits based on a ratio and 
emphasize that a ratio approach does not distinguish between products 
that have low amounts of saturated fat and low amounts of other fat 
versus products that have high amounts of

[[Page 106102]]

saturated fat and high amounts of other fat. Therefore, we share the 
concern that a ratio approach could allow manipulation of fats to allow 
for more saturated fat in a product by increasing other fat sources in 
the product, which goes against the intent of having a saturated fat 
limit. In addition, a ratio approach could result in manipulation to 
add more fat sources in order for a product that contains even a small 
amount of saturated fat to qualify (e.g., if the product contained a 
small amount of saturated fat, but not enough total fat to meet the 
specified ratio).
    We note one exception in the ``healthy'' criteria, for oils and 
oil-based spreads and dressings, where the limit for saturated fat is 
based on a percentage of total fat. The composition of oils is unique 
(primarily made up of fatty acids) compared to the other food groups, 
and we proposed a limit for saturated fat of <=20% total fat for this 
category. See Response 64 for further discussion about the saturated 
fat limit for oils and oil-based dressings and spreads.
    Regarding seafood, we have adjusted the proposed criteria to 
provide more flexibility for nutrient-dense foods that are recommended 
by the Dietary Guidelines (see Response 62 for discussion of saturated 
fat and seafood). For example, all varieties of fish, including fish 
that is high in mono- and polyunsaturated fats but also contains 
saturated fat, can qualify for the ``healthy'' claim based on the 
single-ingredient exemption. A majority of other examples provided in 
comments in support of a ratio can also meet the updated definition 
(e.g., cooked soybeans, cooked edamame, dried chickpeas). See Response 
58 on saturated fat and beans, peas, lentils, and soy products and 
Response 9 for the expanded exemption for single-ingredient nutrient-
dense foods.
    (Comment 66) One comment states that saturated fat, as a single 
amount or a ratio, should not be included as a nutrient to limit as it 
could result in reduced intake of nutrient-dense foods. The comment 
asserts that limiting saturated fat as a class, or single nutrient, is 
too simplistic, noting for example that it does not take into 
consideration individual saturated fatty acids that can have different 
effects. Another comment recommends that careful consideration be given 
when grouping all saturated fatty acids under the general term 
``saturates'' because not all saturates have the same physiological 
effects.
    (Response 66) We disagree that saturated fat should not be included 
as a nutrient to limit and that including it as a nutrient to limit 
would prevent nutrient-dense foods from bearing the ``healthy'' claim. 
As discussed in the proposed rule (87 FR 59168 at 59178), several 
consensus reports reviewing the scientific evidence related to 
saturated fat intake, as well as the Dietary Guidelines, 2020-2025, 
include recommendations to limit saturated fat based on CVD risk. 
Further, dietary recommendations continue to recognize the well-
established relationship between consumption of saturated fat and 
effects on blood cholesterol (87 FR 59168 at 59178). Despite these 
recommendations, 76% of males and 71% of female adults (ages 19-30 
years) in the United States exceed recommended limits for saturated fat 
(Ref. 8). It is important, therefore, to continue to include a limit 
for saturated fat as part of the ``healthy'' definition, while still 
ensuring that there are nutrient-dense foods containing some inherent 
saturated fat that can qualify. The updated ``healthy'' criteria 
framework includes adjustments and exemptions to ensure that nutrient-
dense foods recommended by the Dietary Guidelines can qualify for the 
claim. In the proposed rule, we made adjustments to the baseline 
saturated fat limit for some food groups and subgroups, such as 
increasing the saturated fat limit to <=10% per RACC for dairy products 
to ensure that low-fat dairy could qualify, as recommended by the 
Dietary Guidelines, 2020-2025, and excluding the inherent saturated fat 
in nuts and seeds from the saturated fat limit for that subgroup. 
Further, as discussed above, we have expanded the exemption for raw, 
whole fruits and vegetables to single-ingredient foods recommended by 
the Dietary Guidelines and made adjustments to the proposed criteria so 
that the inherent saturated fat in soybeans and seafood are excluded 
from the saturated fat limit for their respective subgroups. As a 
result, a variety of nutrient-dense foods can qualify for the updated 
``healthy'' claim, particularly when compared to the original 
``healthy'' definition.
    We further disagree that the saturated fat limit is too simplistic 
and does not take into consideration individual saturated fatty acids 
that can have different effects. The Dietary Guidelines, 2020-2025 
provides a quantitative intake recommendation for saturated fat, which 
relates to intake of all saturated fatty acids. The comments did not 
provide details on a suggested alternative grouping or provide data or 
information to support the rationale for an alternative grouping for 
saturated fat, and therefore FDA does not have a basis on which to 
consider alternative groupings. For these reasons, we decline to change 
the classification of the saturated fat group and all individual 
saturated fatty acids are included within the saturated fat group for 
the purposes of the ``healthy'' nutrient content claim criteria.
    (Comment 67) One comment asserts that the Dietary Reference Intake 
(DRI) values for saturated fat, on which the DV is based, were issued 
in the early 2000s and that methodology for developing evidence-based 
guidance has evolved since that time. The comment also states that DRIs 
are predicated on essentiality, and it is unclear if saturated fat is 
an essential nutrient given that humans can synthesize saturated fatty 
acids de novo. Therefore, the comment asserts that the approach used to 
establish a saturated fat DV may not be appropriate and supports a 
ratio approach instead.
    (Response 67) While DRIs are one consideration when determining 
DVs, DVs do not have to be solely or directly based on DRI values. For 
example, there is not a DRI value for saturated fat, and the DVs for 
macronutrients--total fat, total carbohydrate, and protein--are not 
solely based on DRI values. We also note that the DRI framework has 
been expanded to now include chronic disease risk reduction (Refs. 10 
and 11), therefore a DRI value does not need to be based on 
essentiality.
    In the proposed rule (87 FR 59168 at 59178), and the NFL Final Rule 
(81 FR 33742), we provide examples of consensus reports, as well as the 
Dietary Guidelines, 2020-2025, which have reviewed the scientific 
evidence related to saturated fat intake, and recommended saturated fat 
intakes of no more than 10% of calories based on CVD risk. In 2016, we 
reaffirmed in the NFL Final Rule that the 20 g DV, which is 10% of 
calories for a 2,000 calorie reference intake level, is consistent with 
scientific evidence based on CVD risk for the general population (81 FR 
33742 at 33786). Therefore, the DV for saturated fat is not related to 
whether or not saturated fat is an essential nutrient. Similarly, the 
recommendations in consensus reports, as well as in the Dietary 
Guidelines, to limit daily intake of saturated fat are not based on 
whether saturated fat is essential, but rather on the scientific 
evidence for saturated fat as it relates to CVD risk. The 2020 DGAC 
Report explains that humans do not have dietary requirements for 
saturated fats because they ``synthesize them from other dietary 
substrates''; intake of saturated fat is associated with risk of CVD; 
and the Committee recommends ``saturated fat intake be

[[Page 106103]]

limited to less than of 10 percent of total energy intake, as 
recommended by the 2015-2020 Dietary Guidelines for Americans'' (Ref 
8). While we agree that methodology for developing evidence-based 
guidance has evolved since the early 2000s, we disagree that the DV is 
based on methodology from that time, as the 2020 DGAC, for example, 
used current methodologies to evaluate the body of evidence for 
saturated fat and CVD risk.
    Basing nutrient limits for the use of the ``healthy'' claim on a 
percentage of the DV for saturated fat, added sugars, and sodium, 
instead of on gram amounts (the approach used in the original 
``healthy'' criteria), allows for flexibility and helps ensure 
longevity if DVs are updated in the future. If the DV for saturated fat 
were to change in the future, it would be reflected in the ``healthy'' 
criteria because the limits for the NTL are based on the % DV.
    Lastly, when we asked for comment on an alternative ratio approach, 
the example that we provided in the proposed rule (i.e., a ratio based 
on current DVs for saturated fat and total fat) was based on DVs, 
including the DV for saturated fat. The comment did not provide input 
specifically on that example nor did it suggest, or provide information 
or evidence for, an alternative ratio amount that would not be based on 
DVs. For the reasons described above, we do not have a basis to change 
to a ratio approach and will maintain the overall approach of basing 
the saturated fat limit on a percentage of the DV rather than on a 
ratio (with the exception of the oils group as discussed above).
3. Sodium
    (Comment 68) Many comments agree that sodium should be included as 
a nutrient to limit in the ``healthy'' claim. Some comments agree that 
the proposed <=10% of the DV per RACC baseline limits for individual 
foods, including fruit, vegetable, grain, and dairy products and 
protein foods, are an appropriate step towards curtailing sodium 
consumption. These comments note that most sodium consumed in the 
United States comes from salt added during commercial food processing 
and preparation and that sodium consumption in the United States far 
exceeds the recommended daily intake limit--average intake (ages 1 and 
older) is 3,393 mg/day and the recommended daily limit from the current 
Dietary Guidelines, 2020-20205 is 2,300 mg/day for most ages. A few 
comments argue that the sodium limits should be more restrictive, for 
example, that the baseline limit should be lowered to <=5% DV. Other 
comments agreed with a <=10% DV limit instead of a <=5% DV limit based 
on the functional role that sodium plays in many foods, asserting that 
a sodium limit of <=5% DV is not feasible or practical at this time. 
One comment acknowledges that, while lower sodium limits would be 
preferable, aiming to lower daily intake to 2,300 mg is a more 
realistic goal; however, it also notes that foods that exceed the 
voluntary sodium reduction targets should not be eligible for the 
``healthy'' claim.
    (Response 68) In the proposed rule (87 FR 59168 at 59179), we 
explained that a lower sodium limit for the updated ``healthy'' 
definition should be feasible due to reductions in sodium in certain 
foods in response to consumer support for policies to limit sodium 
content in manufactured foods and technological progress since the 
original definition was issued in 1994. For example, in 2021, FDA 
published short-term (2.5 year) voluntary sodium reduction targets for 
the food industry, as part of a gradual, iterative approach to help 
reduce sodium in the food supply and support reducing sodium intakes 
over time (Ref. 12). In 2024, we issued new, voluntary targets for 
sodium reduction in foods in a draft guidance that serve as Phase II of 
the Agency's ongoing work. The new targets build on the final, 
voluntary sodium reduction goals issued in 2021, now referred to as 
Phase I (Ref. 47). When determining the proposed sodium limit for the 
``healthy'' claim, we considered the many functions of sodium in food, 
including taste, texture, microbial safety, and stability. The sodium 
limit of <=10% DV (currently <=230 mg for adults and children 4 years 
of age and older) is ~50% less than the sodium limit in the original 
criteria for ``healthy'' (480 mg or ~20% DV). As noted, we proposed a 
lower limit (<=10% DV) than the limit in the original criteria because 
of the technological advances and progress that have been made since 
1994 in reducing sodium in foods. We are concerned that a limit of <=5% 
of the DV for sodium would not be practical at this time. Having limits 
that are too restrictive would prevent a variety of nutrient-dense 
foods across foods groups and subgroups from being able to qualify for 
the ``healthy'' claim.
    Compared to the sodium limit in the original definition (480 mg per 
RACC or per 50 g for RACCs <=30 g for individual foods), the lower 
limit of <=10% DV (currently 230 mg) per RACC (or per 50 g for RACCs 
<=50 g or <=3 Tbsp) will allow the updated ``healthy'' claim to help 
consumers identify more nutrient-dense foods that can help them achieve 
a healthy dietary pattern, which is consistent with the Dietary 
Guidelines, 2020-2025. Further, our marketplace review of nutrient-
dense foods demonstrates that a <=10% DV limit permits a variety of 
nutrient-dense foods to qualify across food groups and subgroups, while 
allowing some sodium for processing, preservation, or taste (e.g., low 
sodium canned vegetables) (Ref. 2). For the reasons discussed above, we 
decline to lower the baseline limit for sodium to <=5% DV per RACC. See 
the discussion in Response 69 for a comparison of the sodium reduction 
targets and the criteria for the ``healthy'' nutrient content claim.
    (Comment 69) Some comments raise concerns that the proposed limits 
for sodium are too restrictive and would exclude products encouraged by 
the Dietary Guidelines, 2020-2025, including whole grain tortillas and 
most nutrient-dense low/reduced sodium canned products (e.g., canned 
vegetables). The comments assert that the proposed limits are 
significantly lower (25-50%) than the original ``healthy'' criteria and 
suggest that food products could contain more sodium and still align 
with the Dietary Guidelines, 2020-2025. Some comments state that the 
proposed limits undermine the functional purposes of sodium. The 
comments also assert that sodium is crucial to ensuring the flavor of 
foods that are promoted by the rule and the Dietary Guidelines, 2020-
2025, reasoning that compliance with the <=10% DV limit would result in 
a lack in taste that would discourage consumption of such products, 
even if they bear the ``healthy'' claim.
    Some comments assert that the proposed sodium limits would not 
encourage reformulation and that there is more room to accommodate 
greater amounts of sodium, suggesting different options as alternative 
sodium criteria across food categories, for example:
    1. Individual foods: 0-10% DV per RACC or per 50 g for foods with 
small RACCs; mixed products: 460 mg (20% DV) per RACC and labeled 
serving or per 50 g for foods with small RACCs; main dishes: 600 mg or 
less per labeled serving; and meals: 600 mg or less per labeled 
serving; or
    2. Individual or mixed foods, small RACC (RACC <=30 g/2 Tbsp): 10% 
DV per RACC; individual or mixed foods, RACC >30 g/2 Tbsp: 20% DV per 
RACC; main dishes: 25% DV per serving; and meals: 30% DV per serving.
    The comments argue that the alternative criteria would allow more 
options in the marketplace to be labeled as ``healthy,'' including 
foods that are encouraged by the Dietary Guidelines

[[Page 106104]]

and MyPlate, and those that are affordable, accessible, and culturally 
relevant choices, that do not meet the proposed sodium criteria (e.g., 
canned vegetables, 100% whole grain tortillas, some Special 
Supplemental Nutrition Program for Women, Infants and Children (WIC) 
eligible cereals, and reduced sodium/light soups). A few comments 
advocate for increasing the sodium limit to <=15% DV for individual 
foods because it would provide additional enticements for reformulation 
efforts to lower the sodium levels for foods. One comment, in support 
of keeping the sodium limits for the original ``healthy'' definition, 
notes that when the sodium limit for the original ``healthy'' 
definition of 600 mg is applied to a main dish weighing 270 g (222 mg 
sodium/100 g), it is well below the category target mean of 270 mg/100 
g for the ``frozen meals'' category from the short-term sodium 
reduction targets. In contrast, another comment advocates for a sodium 
limit lower than the proposed limit for meals (30% DV) because meals 
lower in sodium are more consistent with the 2016 draft long-term 
voluntary sodium reduction goals, for example, a typical 9 oz. (255 g) 
frozen meal had a target mean of 460 mg (180 mg/100 g) compared with 
the proposed sodium limit of 690 mg (30% DV) for meals.
    (Response 69) Based on evidence showing a beneficial effect of 
reducing sodium intake on risk of CVD and hypertension, including on 
systolic and diastolic blood pressure, the National Academies 
established the following Chronic Disease Risk Reduction Intake (CDRR) 
values: 1,200 mg/day, ages 1 through 3; 1,500 mg/day, ages 4 through 8; 
1,800 mg/day, ages 9 through 13; and 2,300 mg/day, ages 14 and above 
(Ref. 11). Data from the Dietary Guidelines, 2020-2025 demonstrates 
that 90% of the U.S. population exceeds recommended limits for sodium 
intake (Ref. 1). In the United States, most sodium consumed comes from 
salt added during commercial processing and preparation of foods 
(including foods that are prepared in restaurants). The Dietary 
Guidelines, 2020-2025 notes that the nutrient-dense choices in the 
Healthy U.S.-Style Dietary Pattern contribute approximately 60-100% of 
the CDRR (for different ages across calorie levels). As a result, there 
is very little room for food choices that are high in sodium in a 
healthy dietary pattern that meets the daily recommended limit for 
sodium, for most calorie levels and at most ages. To reduce sodium 
intake, the Dietary Guidelines, 2020-2025 recommends implementing 
multiple strategies, for example, consuming foods with less sodium in 
all food groups, by using food labels to choose products with no-salt-
added, less sodium, or reduced sodium.
    We explained in the proposed rule (87 FR 59168 at 59179) that we 
expect that it is feasible to lower the sodium limit for the new 
``healthy'' criteria, as compared to the original definition, 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. 17 and 18) and technological progress since 
the original definition of ``healthy'' was finalized in 1994. We 
disagree that the proposed sodium limits do not take into consideration 
the function of sodium in foods. As mentioned above, when determining 
the limits for the ``healthy'' claim, we considered the many functions 
of sodium in food, including taste, texture, microbial safety, and 
stability. We proposed a limit for sodium of <=10% per RACC to allow 
for these considerations. Furthermore, as we stated in the proposed 
rule, while a baseline limit for sodium of <=5% of the DV per RACC 
would be consistent with the proposed saturated fat and added sugar 
baseline limits, we were concerned that a limit of <=5% of the DV per 
RACC for sodium would not be practical.
    Lowering the ``healthy'' sodium limit to <=10% DV also aligns with 
recent FDA initiatives related to sodium reduction in foods. For 
example, these include our 2021 final guidance with voluntary targets 
for reducing sodium in foods (Phase I targets) (Ref. 12), our 2024 
draft guidance with voluntary targets for reducing sodium in foods 
(Phase II targets) (Ref. 47), our 2023 proposed rule to permit safe and 
suitable salt substitutes to reduce sodium in standardized foods (Ref. 
15), and our 2020 enforcement discretion guidance related to use of an 
alternate name for potassium chloride in food labeling (``potassium 
salt'') (85 FR 82332, December 18, 2020). Technological progress and 
efforts such as these, as well as our marketplace review of nutrient-
dense foods, support lowering the sodium limits for the updated 
``healthy'' definition compared to the limits in the original 
``healthy'' definition that were issued in 1994.
    As referenced in some comments to the ``healthy'' proposed rule, 
the 2021 final guidance included 2.5-year voluntary targets for 
commercially processed, packaged, and prepared food. While the sodium 
reduction targets and ``healthy'' criteria are complementary to one 
another and support the same overarching goal--reducing intake of 
sodium in the United States--the purpose, approach, and rationale for 
the limits for the updated ``healthy'' criteria are different than 
those for the sodium reduction targets. The 2021 final guidance for 
industry provides voluntary 2.5 year sodium reduction targets, with 
target mean and upper bound concentrations for 163 categories of food 
that are commercially processed, packaged, and prepared. The 2024 draft 
guidance for industry contains 3-year voluntary sodium reduction 
targets for 163 categories of food that aim to help reduce Americans' 
average sodium intake to about 2,750 mg/day. The ``healthy'' claim, and 
underlying criteria, seeks to help consumers identify foundational 
foods that can help them build a healthy dietary pattern, which would 
consist of intake of less than 2,300 mg of sodium per day, consistent 
with the Dietary Guidelines, 2020-2025.
    We decline to adopt the recommendations in some comments that 
suggest alternative sodium limits. Setting a sodium limit of 20% DV for 
individual foods would not be consistent with the Dietary Guidelines, 
2020-2025, as it would not help consumers identify foods that are 
particularly useful in creating healthy dietary patterns because they 
are nutrient-dense, e.g., containing little or no sodium. Instead, 
products that contain 20% DV of sodium per serving would be considered 
to be high in sodium based on our regulations. Our nutrient content 
claims regulations at Sec.  101.54(b) allow for the use of claims 
indicating that a food is an ``excellent source of,'' ``high,'' or 
``rich in'' a nutrient if it contains 20% or more of the DV per RACC. 
According to current nutrition science and Federal dietary guidance, 
consumers should strive to limit sodium in their diets as part of 
building healthy dietary patterns rather than to get enough of it. 
Therefore, it would not be appropriate or consistent with current 
dietary recommendations to set a sodium limit for the use of the 
``healthy'' claim that is equal to the amount required for the use of 
claims indicating that a food is ``an excellent source of,'' ``high 
in,'' or ``rich in,'' a nutrient.
    The intent of the updated sodium limits for the ``healthy'' claim 
is to ensure both a sufficient number and variety of nutrient-dense 
foods, across different food groups and subgroups recommended by the 
Dietary Guidelines, 2020-20205, can bear the ``healthy'' claim, while 
also being rigorous enough to distinguish foods that are particularly 
useful in building a healthy dietary pattern. The sodium

[[Page 106105]]

limits may also result in industry innovation, which can increase the 
availability of lower sodium nutrient-dense foods in the marketplace 
and help consumers build healthier dietary patterns.
    Our marketplace review demonstrates that a sodium limit of <=10% 
DV, combined with other permitted exemptions (see Response 9), results 
in a variety of nutrient-dense individual foods across all food groups 
qualifying for ``healthy'' (including nutrient-dense foods included in 
the Dietary Guidelines and MyPlate website) without resulting in foods 
that contain unnecessary excess sodium to bear the claim (Ref. 2). For 
example, it shows that different forms of food products across food 
groups, including affordable, accessible, and culturally relevant 
nutrient-dense foods could qualify to bear the ``healthy'' claim 
because they can meet a sodium limit of <=10% DV, such as canned, 
dried, frozen, and other shelf-stable or packaged products (e.g., 
options for canned vegetables and 100% whole grain tortillas) and also 
accommodates some of the functional purposes of sodium.
    Accordingly, we have determined that a baseline sodium limit of 
<=10% DV per RACC (or per 50 g for RACCs <=50 g or <=3 Tbsp) for 
individual foods results in a variety of nutrient-dense foods across 
recommended food groups qualifying for the ``healthy'' claim while 
ensuring that foods that can qualify for ``healthy'' do not contain 
unnecessary excess sodium, and we therefore decline to increase the 
sodium limit. See Response 8 for further discussion of criteria for 
small RACC foods. Also see section V.E (``Combination Foods'') for 
discussion of specific criteria for combination products, including 
mixed products, main dishes, and meals.
    (Comment 70) Some comments supporting the alternative criteria 
described in the previous comment summary suggest that such alternative 
criteria would help consumers adapt to a stepwise reduction of sodium. 
Similarly, some comments suggest that a stepwise approach imposes 
flexible sodium limits on a product-by-product basis, while accounting 
for products' contributions to healthy dietary patterns. For example, 
some comments recommend that the small RACC (<=30 g) individual and 
mixed food category have their own limit (e.g., <=10% DV) on the 
grounds that these changes would reflect the smaller consumption of 
these foods in a diet. Some comments suggest that the most effective 
approach to lower sodium in foods is to use a stepwise, gradual 
reduction of sodium in line with FDA's 2021 voluntary sodium reduction 
targets guidance, reasoning that the guidance ``involves a level of 
precision with respect to sodium targets for specific products within a 
category/RACC that the `healthy' sodium criteria would not be able to 
reach.'' One comment asserts that the ``healthy'' sodium limits are not 
consistent with and are ``unusually dramatic'' compared with other 
federal dietary policy and references a USDA proposed rule from 
February 2023, ``Children's Nutrition Program: Revisions to Meal 
Patterns Consistent With the 2020 Dietary Guidelines for Americans'' 
(88 FR 8050, February 7, 2023) in which the USDA proposed a gradual 
reduction in school meal sodium limits.
    (Response 70) We agree that there should be a stepwise approach 
across food categories (i.e., gradual or incremental increases in 
sodium for individual foods with a smaller RACC, individual foods with 
larger RACCs, mixed products, main dishes, and meals). As discussed in 
Response 8, we have decided to modify the criteria by providing 
specific criteria for foods with smaller RACCs as recommended in many 
comments. In addition, in section V.E (``Combination Foods'') we 
discuss our incremental or stepwise approach for setting the NTL for 
mixed products, main dishes, and meals.
    In the previous response, we described the differences in the 
specific aims, approaches, and rationales for the voluntary sodium 
reduction targets and the sodium limits for the updated ``healthy'' 
definition. Accordingly, while these two efforts align in their support 
of the role of lower sodium foods in healthy dietary patterns, we 
disagree that the limits for sodium for foods that bear the ``healthy'' 
nutrient content claim should match the sodium reduction targets that 
are for 163 categories of food commercially processed, packaged, and 
prepared by industry.
    Similarly, there are differences in the specific aims, approaches, 
and rationales between the sodium limits in the 2023 USDA child 
nutrition meal patterns proposed rule, and the recently issued 2024 
final rule, and the sodium limits for the updated definition for the 
voluntary ``healthy'' nutrient content claim. As an example of one of 
the key differences, the sodium limits in the USDA final rule apply, on 
average, to school meals offered during a particular school week (89 FR 
31962). The sodium limits for ``healthy'' are based on a per RACC or 
per labeled serving basis, whereas the USDA sodium limits for school 
meals apply, on average, to lunches and breakfasts offered during a 
school week and do not apply per meal or per menu item. For example, 
under the USDA final rule, specific products are not held to specific 
sodium limits, but meals need to fit in the overall weekly limit. As a 
result, meals, menu items, or products with higher sodium can be 
offered if they are balanced out with products with lower sodium 
throughout the school week. In contrast, the ``healthy'' claim, when 
voluntarily used on a food label or in food labeling, is intended to 
help consumers identify foods that are particularly useful, because of 
their nutrient levels, for serving as a foundation for a healthy 
dietary pattern. While there were multiple proposed sodium reduction 
dates in the USDA proposed rule, the USDA final rule has a single 
sodium reduction for both school lunch and breakfast, to occur in 
school year 2027-2028. The USDA final rule gives schools and the school 
food industry an endpoint to work toward in the near-term, while still 
providing time to gradually reduce sodium prior to implementation. We 
disagree that the ``healthy'' proposed sodium limit of <=690 mg per 
labeled serving for meals is unusually restrictive compared to the 
sodium limits in the USDA final rule for school meals (see section V.E 
(``Combination Foods'') for more information on sodium limits for mixed 
products, main dishes, and meals). Further, as noted in their final 
rule, USDA used FDA's sodium reduction targets from the 2021 final 
guidance (now being referred to as Phase I) to inform the proposed 
weekly sodium limits for the school lunch and breakfast programs. As 
discussed in Response 69 and above, there are differences in the 
specific aims, approaches, and rationales for the FDA voluntary sodium 
reduction targets and the sodium limits for the updated ``healthy'' 
definition--which seeks to help consumers identify foundational foods 
that can help them build a healthy dietary pattern consistent with the 
Dietary Guidelines, 2020-2025 (e.g., consisting of sodium intake of 
less than 2,300 mg per day). Similarly, while the sodium limits for 
school meals and the sodium limits for the ``healthy'' claim both 
support the role of lower sodium foods in healthy dietary patterns, 
these efforts have different purposes and considerations, and they use 
different approaches.
    (Comment 71) Other comments reference ``Food Labeling; Nutrient 
Content Claims, Definition of Sodium Levels for the Term `Healthy' '' 
(70 FR 56828, September 29, 2005) (``2005 sodium final rule''), 
specifically the decision to eliminate the ``second tier''

[[Page 106106]]

(more restrictive) sodium limits, corresponding to ~15% of the DV, from 
the 1994 ``healthy'' definition, based in part on concerns from 
industry regarding the feasibility of reformulating products to meet 
reduced sodium limits.
    (Response 71) The intent of the two-tiered sodium levels 
established by the 1994 final rule was to encourage industry to be 
innovative and further lower sodium levels in foods bearing the claim 
``healthy.'' In 2005, we decided to retain the higher ``first-tier'' 
sodium limits, in part, because of the challenges related to the 
feasibility at that time of meeting the lower limits, including 
technological barriers to reducing sodium in foods that were in the 
marketplace at that time. In the 2005 sodium final rule (70 FR 56828 at 
56834), we stated that we had anticipated that phasing in the lower 
second-tier sodium level requirement for the term ``healthy'' would 
allow the food industry time to develop technically and commercially 
viable alternatives to salt. We said at that time that, although it is 
unfortunate that no viable alternative has been found, we understand 
the manufacturing difficulties that are presented by the absence of a 
suitable substitute for salt and has taken them into consideration in 
deciding how to regulate the sodium content of foods bearing the 
``healthy'' claim. We also stated that: ``[w]hen FDA issued the 1994 
final rule providing for a phased-in second-tier sodium level . . . 
[we] had anticipated that with the passage of time, there would be 
sufficient technological progress to make it feasible to implement this 
lower sodium level requirement for foods labeled as `healthy' '' (70 FR 
56828 at 56836). Since 2005, there have been some substantial sodium 
reduction efforts, including technological advances such as development 
and usage of safe and suitable salt substitutes to help manufacturers 
reduce sodium in foods. Taking into account the compliance date for 
this final rule for updating the ``healthy'' definition, over 30 years 
will have passed since the original ``healthy'' definition was issued 
and over 20 years will have passed since the 2005 sodium final rule on 
defining sodium levels for the ``healthy'' claim. While we have 
provided some flexibility for mixed products (compared to the proposed 
rule) and for meals (compared to the original ``healthy'' definition), 
(see discussion of combination foods in section V.E), the lower sodium 
limits for individual foods and main dishes, compared with the original 
``healthy'' definition, are consistent with the progress that has been 
made over this time. Additionally, we expect that progress in these 
areas will continue going forward, consistent with sodium reduction 
efforts such as those described above.
    (Comment 72) Some comments raise concerns that the proposed sodium 
limits of <=10% DV are too restrictive for certain food groups, 
subgroups, or types of products. In, brief, the comments identified the 
following products as possibly not being able to meet the proposed 
sodium limits:
     Many frozen foods (e.g., seafood products), including 
frozen foods that meet the original ``healthy'' criteria (e.g., frozen 
vegetables in a tomato sauce).
     Canned foods (e.g., vegetables).
     Some fresh seafood, without added ingredients, that 
typically have a sodium content above the proposed limit.
     Soup, including reduced sodium/light soups. One comment 
points out that soups have a RACC of 245 g or approximately 8 ounces, 
larger than the RACC for main dishes, which must weigh a minimum of 6 
ounces; however, soups qualify as an individual/mixed product with a 
proposed limit of <=10% DV, while main dishes have a proposed sodium 
limit of <=20% DV.
     Many plant-based products, such as those made with soy 
(e.g., plant-based patties).
     Liquid oil-based dressings.
     Many whole grain products, including bread and tortillas.
     Cheeses.
    One comment argues that four eating occasions per day allows for 
consumption of 25% DV for sodium at each occasion and that the proposed 
limits only allow ``healthy'' grain products to contain 10% DV for 
sodium. Other comments discuss the different functions of sodium in 
foods and note that the feasibility of lowering sodium in certain 
products is challenging (e.g., soups and cheeses). Specifically, one 
comment suggests that FDA allow ``formulation flexibility'' related to 
standards of identity, e.g., for cheeses that are required by their 
standards of identity to use salt, so that more cheese products can 
qualify for the ``healthy'' claim. The comment asserts that permitting 
the use of salt alternatives in standardized cheeses will allow further 
innovation by the dairy industry and allow more cheeses to qualify for 
the ``healthy'' claim while meeting standards of identity. The comment 
further recommends that FDA issue enforcement discretion or a direct-
to-final rule, simultaneously with the ``healthy'' final rule, to allow 
the use of salt alternatives in standardized cheeses.
    Many comments request more flexibility in the sodium limits for 
specific food groups, subgroups, or products, so that more of products 
listed above can bear the healthy claim, noting that a moderate amount 
of sodium increases palatability of foods that provide important 
nutrients, such as seafood (e.g., frozen fish) and dairy (e.g., 
cheese). In contrast, one comment concurs with the proposed limit on 
sodium for the dairy food group. For frozen foods, comments highlight 
the importance of availability of affordable, frozen products to low-
income families. Some comments suggest increasing the limits for both 
sodium and added sugars to <=20% DV for grain products.
    (Response 72) As explained above, the Dietary Guidelines, 2020-2025 
suggests that consumers use food labels to choose products with no-
salt-added, less sodium, or reduced sodium. The Dietary Guidelines, 
2020-2025 describes nutrient-dense foods and beverages as products that 
provide vitamins, minerals, and other health-promoting components, 
while having little or no saturated fat, sodium, and added sugars. 
Along with our consideration of the Dietary Guidelines, we used our 
marketplace review to demonstrate whether nutrient-dense foods across 
food groups could meet the <=10% DV sodium limit for individual foods, 
including products mentioned in comments such as whole grain breads, 
tortillas, and English muffins; frozen and fresh seafood; reduced/light 
sodium soups; reduced sodium/low sodium canned vegetables, frozen 
vegetable blends in sauces, and plant-based patties (Ref. 2).
    Frozen vegetable blends and plant-based patties. Certain frozen 
vegetable blends in sauces could qualify as a mixed product depending 
on the individual components of the food (i.e., if they meet the FGE 
requirements for mixed products). We have provided more flexibility for 
sodium in mixed products by increasing the limit from <=10% DV to <=15% 
DV per RACC (or per 50 g for RACCs <=50 g or <=3 Tbsp), which is 
discussed in section V.E.2 (``Mixed Product''). The higher sodium limit 
for mixed products could also provide more flexibility for products 
mentioned in the comments, for example plant-based patties, such as 
those made with soy, depending on the individual components of the 
product. There are other vegetable blends with sauces and plant-based 
patties that will not qualify for the ``healthy'' claim because their 
sodium amount exceeds the <=15% DV limit for mixed products, or because

[[Page 106107]]

they do not meet the minimum FGEs for a mixed product and their sodium 
exceeds the <=10% DV limit for individual foods.
    Canned vegetables. For canned vegetables, amounts of sodium vary 
widely, including in reduced-sodium canned vegetables. An individual 
food labeled as ``low sodium'' would need to contain 140 mg or less per 
RACC (or per 50 g for foods with RACC <=30 g) (Sec.  101.61(b)(4) (21 
CFR 101.61(b)(4))). Therefore, all ``low sodium'' foods, including all 
``low sodium'' canned vegetables would meet the 10% DV sodium limit, 
which is currently 230 mg. For a food labeled as ``reduced sodium,'' 
the food needs to contain at least 25% less sodium per RACC than an 
appropriate reference food (see Sec.  101.61(b)(6)). Therefore, the 
amount of sodium can vary for reduced-sodium canned vegetables 
depending on the sodium amount in the reference food (which is also 
similar for foods labeled as ``light''), and these products could still 
contain higher amounts of sodium. Our marketplace review demonstrates 
that many canned vegetables, including low-sodium canned vegetables and 
some reduced-sodium vegetables, can meet a <=10% DV sodium limit (Ref. 
2). Canned vegetable products that meet the ``healthy'' claim are 
products that are particularly useful, because of their nutrient 
content (including sodium amounts), in helping consumers identify foods 
that can be the foundation of a healthy dietary pattern. Canned 
vegetable products that have sodium in excess of 10% DV are not 
necessarily unhealthy (e.g., they can still be part of a healthy 
dietary pattern) and their beneficial nutritional attributes can be 
communicated in other ways that are not false or misleading. Therefore, 
we have decided to finalize the <=10% DV per RACC (or per 50 g for 
RACCs <=50 g or <=3 Tbsp) sodium limit for individual foods for the 
vegetable food group and for the beans, peas, and lentils subgroup.
    Seafood. The expanded exception for whole, raw fruits and 
vegetables to other forms (e.g., frozen) and to other foods recommended 
by the Dietary Guidelines, 2020-2025, in other food groups (e.g., 
seafood), will result in fresh and frozen seafood without added 
ingredients qualifying for the ``healthy'' claim without being subject 
to FGE or NTL requirements, including the sodium limit (see Response 
9). Our marketplace review indicates that there are additional seafood 
products, i.e., besides single-ingredient seafood (including some 
frozen seafood products), that can also meet the <=10% DV limit (Ref. 
2). Seafood products that qualify for the ``healthy'' claim are 
products that are particularly useful, because of their nutrient levels 
(including sodium amounts), for helping consumers identify foods that 
are foundational for a healthy dietary pattern. As emphasized in the 
Dietary Guidelines, 2020-2025, there is little room in most healthy 
dietary patterns for excess sodium. Therefore, we have decided to 
finalize the sodium limit of <=10% DV per RACC (or per 50 g for RACCs 
<=50 g or <=3 Tbsp) for individual foods for the seafood group. Seafood 
products that are not able to meet the sodium limit are not necessarily 
unhealthy and can still be included as part of a healthy dietary 
pattern. Further, their beneficial nutritional attributes can be 
communicated with other label statements and claims, provided they are 
not false or misleading.
    Soup. For soup, sodium content varies widely, with most soups 
containing a high amount of sodium (>=20% DV). A majority of soups do 
not meet the sodium limits for the original ``healthy'' claim. While 
some dry soup mixes can meet the updated sodium limits for ``healthy,'' 
most ``wet soups'' cannot. Wet soups are those that contain liquid 
(i.e., they exclude dry soup mixes). Our marketplace review of wet 
soups, including reduced sodium and light soups, demonstrates that over 
70% of wet soups contain a high amount, at least 460 mg (>=20% DV), of 
sodium per RACC, with numerous containing >=1,000 mg of sodium per RACC 
(Ref. 2). As mentioned above, an individual food labeled as ``low 
sodium'' would need to contain 140 mg or less per RACC (or per 50 g for 
foods with RACC <=30 g) (Sec.  101.61(b)(4)). Low-sodium foods, 
including low-sodium soups, would therefore meet the <=10% DV sodium 
limit for individual foods, which is currently 230 mg. We note that 
there are also some soups with no added salt, which only contain small 
amounts of sodium, that also meet the sodium limit for individual 
foods. As mentioned above, foods labeled as ``reduced sodium'' contain 
at least 25% less sodium per RACC than an appropriate reference food 
(Sec.  101.61(b)(6)). The nutrient content claim ``light'' may be used 
on a food if the sodium is reduced by 50% or more compared to the 
reference food, and other requirements are met (e.g., the reference 
food contains <=40 calories and <=3 g of fat per RACC) (21 CFR 101.56). 
Because the amount of sodium varies for reduced sodium and light soups 
depending on the sodium amount in the reference food, these products 
could still contain higher amounts of sodium. As previously mentioned, 
we have increased the sodium limit for mixed products to <=15% DV per 
RACC (or per 50 g for RACCs <=50 g or <=3 Tbsp). This change will 
provide more flexibility for products, such as certain soups, to meet 
the sodium limit for mixed products compared to the proposed limit of 
<=10% DV. Based on their ingredients, it is possible that certain soups 
could meet the FGE requirements for a main dish and in those cases the 
sodium limit would be <=20% DV per labeled serving. We recognize, 
however, that most soups currently in the marketplace will exceed the 
sodium limits for individual foods, mixed products, and main dishes and 
that sodium reduction in soups can be challenging. As discussed, foods 
that qualify to bear the ``healthy'' claim are foods that, because of 
their nutrient levels (including amounts of sodium), are particularly 
useful in building healthy dietary patterns. Soups that cannot bear the 
``healthy'' claim are not necessarily unhealthy, nor does the absence 
of a ``healthy'' claim indicate that these soups are unable to provide 
any nutritional benefits. Soups, such as reduced sodium or light soups, 
can be part of a healthy dietary pattern, and their beneficial 
attributes can be conveyed to consumers in other ways that are not 
false or misleading (e.g., other nutrient content claims).
    Oil-based dressings oil-based spreads, and 100% oils. In the 
proposed rule, we proposed lowering the baseline sodium limit to <=5% 
DV for oil-based dressings and oil-based spreads because of their small 
RACC sizes. However, as previously discussed, we have now provided 
different criteria for smaller RACC foods (i.e., qualifying on a 50-
gram basis instead of per RACC for foods with RACCs <=50 g or <=3 
Tbsp). As a result, and as supported by our marketplace review (Ref. 
2), it is not necessary to reduce the sodium limit to <=5% DV for oil-
based dressings and oil-based spreads due to their small RACC since 
their criteria will be based on 50 grams. Therefore, the final rule has 
a sodium limit of <=10% DV per 50 g for oil-based dressings and oil-
based spreads. In addition, we are finalizing the proposed sodium limit 
of 0% DV for 100% oils.
    Grain products. Nutrient-dense forms of whole grains, including 
whole grain bread and cereal products, can qualify for the claim. 
Several comments grouped their comments about sodium together with 
added sugars (e.g., asserting that the proposed added sugar and sodium 
limits for grain products would prevent a vast majority of whole grain 
breads, buns, tortillas, and cereals

[[Page 106108]]

from qualifying from ``healthy''). In those cases, it is difficult to 
distinguish between the specific concerns with the sodium limits versus 
the specific concerns with the added sugars limits for some of the 
example products mentioned in the comments. However, we disagree that a 
<=10% DV sodium limit would prevent a ``vast majority'' of whole grain 
bread products from qualifying, as our marketplace review shows that 
there are many whole grain bread products (including several English 
muffin products) that already meet a <=10% DV limit (Ref. 2). We note 
that we have provided more flexibility for the added sugars limit for 
whole grain products by increasing the limit from <=5% DV to <=10% DV 
for the grains group, which is discussed in section V.D.4 (``Added 
Sugars''). We further disagree that 100% whole grain tortillas would be 
unable to qualify for the updated ``healthy'' claim as indicated in 
some comments. Our marketplace review demonstrates that some 100% whole 
grain tortillas are currently able to meet the sodium limit for the 
updated ``healthy'' criteria (Ref. 2). We also note that most tortillas 
are not able to qualify for the original ``healthy'' definition (e.g., 
do not contain 10% of a specified beneficial nutrient, with the 
exception of those with added fiber). The Dietary Guidelines, 2020-2025 
points out that the grains that are typically consumed in the United 
States are forms with higher amounts of sodium and lists tortillas as 
one of the examples. They discuss that shifts to more nutrient-dense 
forms of grains will help in building healthy dietary patterns. 
Therefore, the sodium limit of <=10% DV (or per 50 g for RACCs <=50 g 
or <=3 Tbsp) for individual foods results in nutrient-dense options in 
the grains group qualifying for the claim, and can consequently help 
consumers identify foods that are particularly useful for building a 
healthy dietary pattern that is consistent with current nutrition 
science and Federal dietary guidance. Therefore, we have decided to 
finalize the <=10% DV per RACC (or per 50 g for RACCs <=50 g or <=3 
Tbsp) sodium limit for the grains group.
    We also disagree with the comments asserting that the sodium limit 
for grains will impact consumers' ability to access whole grain 
products. Setting a sodium limit of 20% DV for individual foods, as 
suggested by some comments, would not be consistent with the Dietary 
Guidelines as it would not help consumers identify whole grain foods 
that are nutrient-dense, e.g., containing little or no sodium. As noted 
above, products that contain 20% DV or more of sodium per serving would 
be considered high in sodium. We note that the ``healthy'' criteria do 
not prevent products that cannot qualify to bear the claim from being 
sold, and, as stated previously, the absence of a ``healthy'' claim on 
a food does not mean that the food is ``unhealthy.'' Foods that do not 
qualify for the ``healthy'' nutrient content claim can still be part of 
a healthy dietary pattern. In contrast, foods that can bear the 
``healthy'' claim are foods that, because of their nutrient content, 
including amounts of sodium, are particularly useful in building a 
healthy dietary pattern.
    Dairy. We acknowledge the different functions of sodium in foods, 
and, as discussed in the proposed rule and above, the functions of 
sodium were a consideration when allowing additional flexibilities for 
the proposed baseline limits for sodium compared to those for saturated 
fat and added sugars. We also understand that sodium reduction can be 
more challenging for certain foods, such as cheeses, and that sodium 
varies widely across different cheese products. Our marketplace review 
of nutrient-dense foods demonstrates that there are numerous foods that 
meet a <=10% DV sodium limit in the dairy food group, including 
different nutrient-dense milk and yogurt products (Ref. 2). The Dietary 
Guidelines, 2020-2025 notes that dairy is usually consumed in forms 
that contain higher amounts of sodium, such as cheese (e.g., cheese in 
mixed dishes, including sandwiches, pizza, and pasta dishes). While 
some cheeses can meet a <=10% DV sodium limit per RACC, or per 50 g for 
RACCs <=50 g, most cheeses will not meet a <=10% DV sodium limit and 
10% DV saturated fat limit per RACC, or per 50 g for RACCs <=50 g or 
<=3 Tbsp. We agree that allowing more flexibility for manufacturers to 
use salt substitutes in standardized foods would help reduce sodium 
content of standardized foods, including standardized cheeses and 
related cheese products. As noted above, in 2023 we issued a proposed 
rule, ``Use of Salt Substitutes To Reduce the Sodium Content in 
Standardized Foods'' (Ref. 15). In the proposed rule, we propose to 
amend our standard of identity regulations that specify salt (sodium 
chloride) as a required or optional ingredient to permit the use of 
salt substitutes in standardized foods.
    We agree that allowing salt substitutes in standardized foods would 
provide food manufacturers with new flexibility to use salt substitutes 
and would support further innovation by food manufacturers that could 
lead to a greater number of products that can meet the sodium limits 
for the ``healthy'' claim, including dairy, grain, and canned vegetable 
products.
    Therefore, we have decided to finalize the sodium limit of <=10% DV 
per RACC (or per 50 g for RACCs <=50 g or <=3 Tbsp) for individual 
foods for the dairy food group.
    Other. We also disagree with the rationale that having four eating 
occasions per day equates to 25% DV for sodium at each eating occasion, 
which supports a sodium limit of 20% DV for individual foods, such as 
grain products. The sodium limits in the ``healthy'' definition are 
intended to ensure that the foods that bear the claim are those that 
can help consumers stay below the daily limit of sodium. Consumers do 
not eat a diet composed entirely of foods that qualify as individual 
foods for the ``healthy'' claim, and multiple foods containing sodium 
could be eaten at one eating occasion. Therefore, basing the sodium 
limit on this type of calculation could result in foods bearing the 
``healthy'' claim that would not help consumers stay beneath the daily 
sodium limit.
    We did not receive comments that the proposed sodium limits of 
<=10% DV were too restrictive for fruits, game meats, eggs, and nuts 
and seeds (see ``Frozen vegetable blends and plant-based patties'' 
section above for discussion of soy products), and are finalizing a 
sodium limit of <=10% DV per RACC (or per 50 g for RACCs <=50 g or <=3 
Tbsp) for fruits, game meats, eggs, and nuts, seeds, and soy products.
    (Comment 73) One comment recommends that FDA evaluate the 
possibility of incorporating the ratio of sodium to potassium as an 
alternative criterion that would apply to products that exceed the 
proposed limit of 230 mg sodium per RACC. Another comment requests that 
we either adopt higher sodium limits in general--individual or mixed 
foods, small RACC (RACC <=30g/2 Tbsp): >=10% DV per RACC; individual or 
mixed foods with RACC >30g/2 Tbsp: >=20% DV per RACC; main dishes: 
>=25% DV per serving; and meals: >=30% DV per serving, or adopt these 
higher sodium limits for food products that contain at least as much 
potassium as sodium (i.e., a ratio of 1:1 or <1) and allow NTE as an 
alternative option to FGEs. The comment discusses the importance of 
potassium in cardiovascular and bone health; the low intake of 
potassium in the United States; the relationship of potassium and 
sodium on blood pressure; the 2019 National Academies report on Dietary 
Reference Intakes (DRI) for Sodium and Potassium; FDA actions related 
to potassium labeling,

[[Page 106109]]

including potassium salt; and that public health efforts to reduce 
sodium intake may also inadvertently reduce potassium intake.
    (Response 73) We previously explained why including sodium as one 
of the NTL for the updated ``healthy'' definition is consistent with 
dietary recommendations, and the underlying scientific evidence on 
which they are based, which support the relationship between sodium and 
blood pressure and risk of CVD. The 2020 DGAC Report mentions the 
relationship between sodium and potassium and the association with 
blood pressure and CVD (Ref. 8). However, the Dietary Guidelines, 2020-
2025 does not discuss potassium in relation to sodium recommendations, 
nor does it include a specific recommendation for potassium (besides 
the inclusion of the DRI values in Appendix 1) or recommendations for a 
specific ratio of sodium to potassium (Ref.1). Other organizations and 
consensus reports from authoritative bodies have also not adopted a 
sodium-to-potassium ratio recommendation instead of, or in addition to, 
individual recommendations for sodium limits (and individual potassium 
limits in some cases). For example, the 2019 National Academies DRI 
report for sodium and potassium concluded that there was insufficient 
evidence to characterize the relationship between the ratio of sodium 
to potassium and health outcomes (Ref. 11). Therefore, the National 
Academies DRI authoring committee was unable to establish the sodium 
and potassium DRIs based on a ratio and unable to assess the behavioral 
implications of recommending a ratio (Ref. 11). The National Academies 
DRI committee expressed concern in the DRI report that establishing a 
DRI value as a sodium-to-potassium ratio might lead to the 
misimpression that using a potassium supplement to modify the ratio 
would be beneficial, which has not yet been evaluated. They noted that 
further investigation into the interactions of sodium and potassium is 
needed.
    We agree that potassium is an underconsumed nutrient and that it is 
important for health, including because (among other things) of its 
role in lowering blood pressure, as we discussed in the NFL Final Rule 
in support of the mandatory declaration of potassium on the label (81 
FR 33742). We also agree that use of potassium chloride can help lower 
sodium in the food supply and that the substitution of potassium 
chloride for sodium chloride can have beneficial impacts on public 
health by reducing intake of sodium, which is overconsumed, and 
increasing intake of potassium, which is underconsumed. Recent efforts, 
such as our 2020 final guidance on naming of potassium chloride in food 
labeling and our 2023 proposed rule to permit salt substitutes in 
standardized foods, support the use of salt substitutes like potassium 
salts in foods to help reduce sodium in the food supply (Refs. 14 and 
15). We agree that use of potassium salts is one tool that could be 
used to reduce sodium in foods that could then potentially bear the 
``healthy'' claim. However, we disagree that our positions and actions 
about potassium and the use of potassium chloride as a salt substitute 
in foods is reason to include potassium as part of the sodium limit for 
the updated ``healthy'' definition, or reason to include NTE as part of 
the updated definition (see section V.D.6 (``Nutrients to Encourage'') 
for discussion of NTE). The Dietary Guidelines, 2020-2025 notes that if 
individuals consume healthy dietary patterns, they can meet 
recommendations for potassium, calcium, and dietary fiber, and that 
consumers should be encouraged to make shifts to increase intakes of 
vegetables, fruits, beans, whole grains, and dairy to increase intakes 
of potassium, calcium, and dietary fiber closer to recommendations. The 
approach for the updated ``healthy'' definition, which incorporates 
food group requirements (i.e., minimums) and includes multiple 
flexibilities for underconsumed food groups and subgroups (e.g., 
adjustments to FGE requirements for vegetable and dairy products and 
adjustments to NTL for whole grain, seafood, and dairy products), is 
intended to help consumers identify foods that are particularly useful 
in building healthier dietary patterns--which help them get closer to 
or meet recommended intakes of food groups and subgroups and, as a 
result, achieve adequate intake of beneficial nutrients, including 
potassium.
    The comment stating that reducing sodium-containing foods may also 
inadvertently reduce potassium-containing foods did not provide any 
data besides referencing shared food sources that are commonly 
consumed. In fact, the comment included a report that suggested a 
potential strategy to prevent an inadvertent reduction in potassium 
intake is the use of potassium salts to partially replace sodium in 
foods. The report summarized a modeling study showing that the 
substitution of sodium with potassium salts in the top sources of 
sodium resulted in an estimated decrease of sodium intake of 9% with an 
accompanying increase in potassium intake of 16% (Ref. 16). The use of 
potassium salt in the food supply has increased in recent years, and we 
anticipate that its usage may continue to increase. Additionally, 
because potassium is required on the Nutrition Facts label (Sec.  
101.9(c)(8)), consumers can use that label to determine and compare 
amounts of potassium in different foods.
    Similar to the discussion in section V.D.2 (``Saturated Fat'') 
related to a ratio approach for saturated fat, a ratio approach for 
sodium (e.g., using a ratio of sodium to potassium for products that 
exceed the proposed limit of 230 mg sodium per RACC, as recommended in 
the comment) would add complexity to the ``healthy'' definition and 
does not distinguish between products that have low amounts of sodium 
and low amounts of potassium versus products that have high amounts of 
sodium and high amounts of potassium. Similarly, having higher sodium 
limits for products that contain a certain amount of potassium (as 
requested in the comment) would also result in foods that are high in 
sodium qualifying for ``healthy,'' which is not in alignment with the 
Dietary Guidelines, 2020-2025. For the reasons discussed above, we 
decline to include a ratio of sodium to potassium as an alternative to 
the sodium limit or adopt higher sodium limits for foods that contain 
at least as much potassium as sodium in the food and allow NTE. We also 
decline to adopt the specific sodium limits for individual/mixed 
products with small RACCs, individual/mixed products with RACC >30 g/2 
Tbsp, and main dishes that were mentioned in the comment that requested 
higher sodium limits in general. The sodium limit for small RACC foods 
in the updated ``healthy'' definition is similar to the sodium limit 
suggested in the comment for individual foods and mixed products with 
small RACCs (except it will be applied to foods with a RACC <=50 g or 
<=3 Tbsp and determined on a 50 g basis) and the ``healthy'' sodium 
limit for meals is the same as that suggested in the comment for meals 
(<=30% DV per serving). We have also increased the sodium limit for 
mixed products (<=15% DV per RACC or per 50 g for RACCs <=50 g or <=3 
Tbsp) and oil-based dressings and spreads (<=10% DV per 50 g) (see 
section V.C (``Food Group Equivalents'') for individual foods and 
section V.E. (``Combination Foods''). Our rationale for not adopting 
the sodium limits suggested in the comment for individual foods with 
RACCs >=30 g (20% DV per RACC) and main dishes (25% DV per

[[Page 106110]]

serving) is also discussed in sections V.C (``Food Group Equivalents'') 
and V.E (``Combination Foods'').
4. Added Sugars
    (Comment 74) Many comments support added sugars limits for products 
bearing a ``healthy'' claim, citing national and international 
recommendations to limit added sugars and research on the association 
between added sugars consumption and increased risk of weight gain and 
chronic diseases. The comments also note that added sugars are 
overconsumed in the United States, accounting for almost 270 calories, 
or more than 13% of total calories per day in the United States 
population (Ref. 1). However, some comments question the need for an 
added sugars limit, suggesting that sugar has been ``unduly vilified.'' 
The comments state that, in the NFL Final Rule, FDA ``conceded that the 
scientific evidence does not establish an independent relationship 
between added sugars and a disease'' and further assert that the 
scientific evidence linking added sugars to chronic illness remains 
inconclusive. The comments suggest that limiting ``healthy'' foods to 
those with no more than 5% of the DV for added sugars is not supported 
by scientific or marketplace evidence or by a regulatory rationale 
because we have not established a ``low'' added sugars nutrient content 
claim.
    (Response 74) As discussed in the proposed rule (87 FR 59168 at 
59178), the Dietary Guidelines, 2020-2025 recommends choosing nutrient-
dense foods across and within food groups while limiting foods and 
beverages higher in added sugars. 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). As noted in some comments, 
limiting added sugars intake is also supported by a number of other 
national and international health and health professional 
organizations. The proposed NTL criteria for added sugars help to 
ensure that foods bearing the ``healthy'' claim are the nutrient-dense 
foods that are particularly useful in creating a healthy dietary 
pattern, as described in the Dietary Guidelines, and do not contain 
excess added sugars, which can have negative health implications.
    Although we stated in the NFL Final Rule that there is not an 
independent association between added sugars and risk of disease (81 FR 
33742 at 33844), there was nevertheless ample scientific justification 
for requiring the mandatory declaration of added sugars. That 
determination was based on evidence related to healthy dietary patterns 
and a reduced risk of chronic disease as well as on evidence showing 
that consumption of higher amounts of added sugars makes it difficult 
to meet nutrient needs within calorie limits. More specifically, we 
required the mandatory declaration of added sugars on the Nutrition 
Facts label due, in part, to strong evidence showing that dietary 
patterns characterized, in part, by lower intakes of sugar-sweetened 
foods and beverages are associated with a decreased risk of CVD (Ref. 
19). In addition, Americans continue to overconsume added sugars (Ref. 
8), which can make it difficult to meet nutrient needs within calorie 
limits. Thus, consumption of added sugars, in excess, has direct 
implications on whether individuals can consume a healthy dietary 
pattern, which is associated with reduced risk of diet related disease, 
without exceeding the amount of calories they need. Given that the 
purpose of the ``healthy'' nutrient content claim is to help consumers 
identify foods that are particularly useful in helping them create a 
healthy dietary pattern, it is important that foods bearing the 
``healthy'' claim not contribute amounts of added sugars to the diet 
that would make it difficult to construct a healthy dietary pattern 
within calorie limits.
    We disagree that the proposed baseline limit of <=5% of DV per RACC 
for added sugars in individual foods (currently <=2.5 g for adults and 
children 4 years of age and older) is arbitrary. While there is no 
``low added sugars'' nutrient content claim, we have established 
requirements for the use of ``low in'' claims for other nutrients 
consistent with the 5% DV limit, making this criterion generally 
consistent with other ``low in'' nutrient content claims. We have also 
reviewed a variety of nutrient-dense products across different food 
groups and subgroups that are recommended by the Dietary Guidelines 
available in the marketplace to compare their added sugar levels with 
the proposed limits (Ref. 2). We are finalizing added sugars limits for 
``healthy'' based on considerations for specific food groups and 
subgroups recommended by the Dietary Guidelines for Americans, 2020-
2025 and supported by our marketplace review.
    (Comment 75) Some comments argue that the proposed added sugars 
limits are inconsistent with the Dietary Guidelines recommendation to 
consume less than 10% of calories per day from added sugars. The 
comments note that the Dietary Guidelines recommend shifts toward 
choosing foods and beverages with less added sugars, but our proposal 
allows no added sugars for some food categories. The comments suggest 
that there is room within a healthy dietary pattern that includes no 
more than 50 g added sugars to accommodate slightly higher amounts of 
added sugars. The comments argue that, with limits of 10-20% of the 
added sugars DV in certain categories, and four eating occasions per 
day, consumers would consume only a portion of the Daily Reference 
Value for added sugars, and it would also leave room in a dietary 
pattern to consume other foods that may not meet the ``healthy'' 
definition.
    (Response 75) We disagree with comments suggesting that the 
proposed added sugars limits are inconsistent with the Dietary 
Guidelines. Since the Dietary Guidelines were first issued in 1980, the 
Dietary Guidelines have included recommendations to limit intake of 
sugars. Since the Dietary Guidelines for Americans, 2015-2020, a 
recommendation has been included in the Dietary Guidelines to limit 
intake of added sugars to less than 10% of calories per day (Refs. 20-
26, 4, and 1).
    We also disagree that it would be appropriate to apply the 
quantitative intake recommendation for added sugars from the Dietary 
Guidelines to individual food products because the recommended limit 
from the Dietary Guidelines is meant to be applied across the diet for 
the entire day rather than to individual foods that make up the diet. 
As previously noted in section III. (``Background''), the ``healthy'' 
claim is used to identify foods that have nutrient content that makes 
them foundational foods for a healthy dietary pattern. Furthermore, the 
recommendation in the Dietary Guidelines is a limit not to be exceeded 
rather than an amount to achieve in the diet. An added sugars limit of 
<=10% of the DV for individual food products across all food categories 
would not help consumers to identify the most nutrient-dense forms of 
many foods recommended by the Dietary Guidelines and would be 
inconsistent with the recommendation to consume less than 10% of 
calories from added sugars per day.
    (Comment 76) Some comments support the <=5% DV per RACC baseline 
limit for added sugars, with adjustments to the added sugars limits for 
certain food categories. The comments suggest that ``healthy'' claims 
on foods loaded with added sugars confuse consumers

[[Page 106111]]

and are out of step with the Dietary Guidelines' advice to limit added 
sugars to achieve a healthy dietary pattern. Some comments say that the 
adoption of stricter limits on added sugars for products making 
``healthy'' claims will help restore consumer confidence in the 
integrity of the claim and prevent misleading ``healthy'' claims on 
products like sugary granola bars, frozen meals, shakes, cereals, and 
other foods and beverages with excess added sugars.
    Other comments raise concerns that nutrient-dense foods recommended 
by the Dietary Guidelines (e.g., whole grain cereals, fruit and 
vegetable products, and nuts) would not be able to meet the ``healthy'' 
criteria due to the added sugars requirements. Comments note that 
sugars are added to nutrient-dense foods for several reasons, including 
palatability, food preservation, and functional attributes (e.g., 
viscosity, water activity, texture, bulk, and browning). The comments 
say that establishing a limit of 0% of calories from added sugars for 
some categories could eliminate some nutrient-dense products from 
qualifying as ``healthy'' and be counterproductive to the goal of 
improving the nutritional quality of Americans' diets. The comments 
suggest that strict limits for added sugars could discourage 
reformulation, and even cause manufacturers to make products that are 
less healthy because the ``healthy'' limits are not attainable.
    Some comments also raise concerns that the proposed added sugars 
limits lack consistency across product categories, with some product 
categories having minimal amounts of either 0% or 2% of the DV for 
added sugars. They indicate that the lack of consistency in added 
sugars limits across food categories could confuse consumers.
    Many comments suggest higher limits for added sugars. The comments 
recommend a baseline limit of at least 5% DV and up to 20% of the DV 
for added sugars for individual foods and mixed products to accommodate 
development of more and better product options that consumers would 
incorporate into their diets. Some comments support a 30% DV added 
sugars limit for meals, 25% DV for main dishes, and proportionally 
smaller amounts for individual foods/mixed products.
    (Response 76) In setting added sugars limits for individual foods, 
we considered several factors, including variability in the need for 
added sugars based on how certain products are typically consumed, 
whether the food category is underconsumed, as well as availability of 
foods in the marketplace with varying amounts of added sugars. As 
discussed in the proposed rule (87 FR 59168 at 59178), applying the 
same added sugars limit across all food groups could result in 
unnecessary addition of sugars to foods. For example, nutrient-dense 
foods, such as eggs, nuts, fruits, and vegetables, are often not 
consumed with the addition of sugar, so setting a limit for these foods 
that is consistent with foods from other food groups that more commonly 
have sugars added to increase palatability, such as whole grain cereals 
and fat-free and low-fat dairy, could result in foods with unnecessary 
excess added sugars qualifying for the ``healthy'' claim'' or the 
unnecessary addition of added sugars to protein foods, fruits, and 
vegetables. We disagree that consumers would be confused by varying 
added sugars limits across food groups. The ``healthy'' nutrient 
content claim acts as a quick signal to consumers that a food, because 
of its nutrient composition, is particularly useful in creating a 
healthy dietary pattern. The added sugars limits for different food 
categories are geared towards manufacturers so they can determine 
whether their products qualify to bear the claim. Therefore, we decline 
to set one added sugars limit for individual food products across food 
categories and are finalizing our approach of setting nutrient limits 
based on considerations for different food categories.
    We also disagree that the added sugars limit for individual foods 
and mixed products should be set at 20% or more of the DV for added 
sugars. Our nutrient content claim regulations allow for the use of 
claims indicating that a food is an ``excellent source of,'' ``high,'' 
or ``rich in'' a nutrient if it contains 20% or more of the DV per RACC 
(Sec.  101.54(b)). As discussed, the Dietary Guidelines, 2020-2025 
recommends choosing nutrient-dense foods while limiting foods and 
beverages higher in added sugars. Therefore, it would not be 
appropriate to set an added sugars limit for the use of the ``healthy'' 
claim that is equal to or greater than the level required for the use 
of claims indicating that a food is ``an excellent source of,'' ``high 
in,'' or ``rich in,'' a nutrient, as that limit would result in foods 
bearing the ``healthy'' claim that are not particularly useful in 
creating a diet that is consistent with current dietary 
recommendations.
    As for the comments expressing concern that some nutrient-dense 
foods recommended by Federal dietary recommendations would not meet 
added sugars limits, we have adjusted some of the added sugars limits 
which results in more nutrient-dense foods encouraged by the Dietary 
Guidelines, 2020-2025 being able to bear the claim. As further 
discussed below, we are increasing the added sugars limit for fruits, 
vegetables, and protein foods as well as for grains. We have also 
adjusted added sugars limits for mixed products, meals, and main dishes 
to provide more flexibility for recipes and the formulation of such 
foods (see section V.E (``Combination Foods''). These changes will 
permit manufacturers to formulate foods with some added ingredients, 
such as seasonings and sauces containing small amounts of added sugars, 
and still qualify for the ``healthy'' claim. Our review (Ref. 2) of 
products available in the marketplace and their added sugars content 
provided additional support for these changes.
    (Comment 77) Some comments note that foods made from recipes on the 
USDA MyPlate Kitchen website (Ref. 27), which provides recipes intended 
to help Americans put the recommendations of the Dietary Guidelines 
into practice, contain levels of added sugars that are greater than the 
proposed limits for the ``healthy'' claim. Other comments assert that 
the proposed added sugars limits for ``healthy'' are inconsistent with 
USDA's recent proposed rule to revise the school nutrition standards. 
The comments say that USDA's proposed rule includes added sugars limits 
that provide significantly more flexibility than FDA's proposed 
``healthy'' criteria, and in some cases 4-5 times the amount of added 
sugars permitted in our proposal. One comment also refers to a 2021 
analysis of the most cost-effective way to follow a dietary pattern 
consistent with the Dietary Guidelines for Americans, 2020-2025 that 
was conducted by the USDA Center for Nutrition Policy and Promotion. 
The analysis of USDA's Thrifty Food Plan (TFP) gives examples of higher 
nutrient density, lower cost foods (Ref. 28). The comment states that 
many of the food sources identified in the TFP report would not meet 
the proposed ``healthy'' criteria.
    (Response 77) Most of the recipes provided on the MyPlate website 
are for mixed products, meals, and main dishes, which have higher added 
sugars limits than individual foods. While all MyPlate recipes contain 
nutrient-dense ingredients and the finished product can be a part of a 
healthy diet, some recipes are for foods, such as desserts (e.g., 
recipes for apple crisps, chocolate squash cake, and banana cupcakes), 
that are not foundational to a healthy dietary pattern. Therefore, we 
disagree that all foods in recipes on the MyPlate website should be 
able to meet the added sugars

[[Page 106112]]

limits for the ``healthy'' nutrient content claim (Ref. 27).
    We also disagree that limits we set for use of the healthy claim 
should be consistent with added sugars limits in the recently issued 
USDA rule that revises meal patterns for the Child Nutrition Programs. 
The ``Child Nutrition Programs: Meal Patterns Consistent With the 2020-
2025 Dietary Guidelines for Americans'' rule (89 FR 31962) updates 
standards in an effort to further improve the nutritional quality of 
school meals.
    It would not be appropriate to align requirements for the 
``healthy'' claim with those of USDA programs, such as the National 
School Lunch Program (NSLP) and WIC, as they serve different purposes. 
The ``healthy'' rule provides criteria for use of a voluntary nutrient 
content claim suggesting that a food, because of its nutritional 
content, is particularly useful in building a healthy dietary pattern. 
However, NSLP requirements are designed to provide age-appropriate 
meals to specific age/grade groups and set minimum standards for school 
meals that schools must follow to receive cash subsidies and USDA foods 
for reimbursable meals served at the school. The NSLP requires five 
meal components, each with daily and weekly minimums, and the current 
requirements provide limits for calories, saturated fat, and sodium. In 
addition, new added sugars limits for school meals will be gradually 
phased in over the next several years. Considerations, such as food and 
labor costs, student participation, and plate waste, are taken into 
account when developing the meal patterns for the NSLP. The WIC food 
packages provide supplemental foods designed to meet the special 
nutrient needs of low-income pregnant, breastfeeding, and non-
breastfeeding postpartum women, infants and children up to 5 years of 
age who are at nutritional risk. Because these programs serve a subset 
of the U.S. population--i.e., students (NSLP) or persons with specific 
nutritional needs (WIC)--it would not be appropriate to base 
requirements for the ``healthy'' nutrient content claim, which is 
applicable to the general U.S. population and based on a healthy 
dietary pattern (i.e., total diet), on USDA requirements for these 
programs.
    The purpose of USDA's TFP is more closely aligned with the purpose 
of the ``healthy'' nutrient content claim in that it is made up of 
specific amounts of various food categories that together comprise a 
practical, cost-effective diet that meets dietary guidance. 
Furthermore, the TFP Market Basket for a reference family of four is 
also based on recommended food group and subgroup amounts in the 
Dietary Guidelines for Americans, 2020-2025 Healthy U.S.-Style Dietary 
Pattern and FNDDS data that we used for our marketplace review (Ref. 
2). However, there are important differences. The modeling categories 
used in the 2021 USDA Center for Nutrition Policy and Promotion 
analysis referenced in comments were designed to prioritize higher 
nutrient-density foods (i.e., those with less added sugars, saturated 
fat, and/or sodium) and consider prices while allowing for food 
diversity in the Market Basket. Cost is an important factor in 
determining the TFP Market Basket, and while we have given 
consideration to whether nutrient limits would exclude low-cost, 
nutrient-dense foods, selecting nutrient limits for the ``healthy'' 
claim that help consumers identify foods that are foundational to a 
healthy dietary pattern is our primary consideration. We also note that 
the examples provided of foods that are deemed to be in the ``higher 
nutrient-density'' category are placed in that category based on 
whether they contain 21.2g/100g of total sugars rather than being based 
on their added sugars content. Furthermore, several examples of 
nutrient-dense whole grain cereals that are part of the TFP provided in 
the comment would be above the 20% or more DV per RACC (the level at 
which FDA permits ``high'' claims under our nutrient content claim 
regulations), which is not consistent with setting a limit that ensures 
that the ``healthy'' claim identifies foods that are particularly 
useful in constructing a healthy dietary pattern. While the limits for 
added sugars may exclude some foods from the TFP from bearing the 
``healthy'' claim, the flexibilities we are providing in the rule with 
the ``single-ingredient exemption'' (see Response 9), as well as 
adjustments to the added sugars limit for grains, fruits, vegetables, 
and protein foods, as discussed below, will result in more nutrient-
dense products included in the TFP being able to bear the ``healthy'' 
claim, consistent with the purpose of the claim.
a. Added Sugars Limits for Food Groups and Certain Food Products
    (Comment 78) Some comments support the proposed limit of 0% of the 
added sugars DV (0 grams) for vegetable, fruit, and protein products, 
while others say the proposed limits for those food groups are too 
restrictive. The comments that oppose the proposed limit say that it 
would not allow for the addition of small amounts of sugars to these 
foods in recipes and by seasonings and other ingredients. The comments 
also note that sugars may be added when formulating recipes to align 
with culinary flavor profiles. In addition, some comments assert that 
small amounts of sugar (1-2 g per serving) may be added to certain 
canned beans, peas, and lentils (e.g., kidney beans) to enhance the 
texture or palatability due to the bitter taste. The comments provide 
examples of foods, such as bagged salads with dressings, frozen fruit 
and grain bowls, frozen vegetable burgers, and canned vegetables that 
could not bear the healthy claim due to the proposed added sugars 
limits. Some comments argue that, by setting a 0% DV added sugars limit 
for fruit, vegetables, and protein food groups, FDA is creating a 
barrier to innovation in these categories. The comments suggest that a 
0% DV limit for added sugars in the fruit, vegetables, and protein 
groups is inconsistent with food pattern modeling used to develop the 
Dietary Guidelines for Americans, 2020-2025 because the nutrient-dense 
reference foods for fruit, whole grains, nuts, and dairy all had low 
amounts of added sugars and were able to be combined within the 
``Healthy US Dietary Pattern.'' Further, some comments state that 
consumers should not be misled to believe that recommended foods, such 
as nuts and seeds, must contain zero added sugars to be ``healthy,'' 
asserting that this is not consistent with Federal dietary policy.
    Some comments also note that recipes in MyPlate Kitchen containing 
fruits and vegetables have between 5-10% of the DV for added sugars. 
The comments refer to the proposed added sugars allowance for oil-based 
dressings of <=2% of the DV to improve palatability of vegetables, but 
note that vegetables, as an individual food product, would not be able 
to contain any added sugars. Further, the comments assert that FDA 
provided no explanation to support its conclusion that whole grain or 
dairy-based foods are ``healthy'' when containing <=5% DV added sugars, 
but fruits, vegetables, and nut and seed-based products are not.
    Other comments state that products such as nuts and seeds are often 
consumed as components of mixed products and express concern regarding 
the proposed 0% DV limit for added sugars for certain protein foods, 
including nuts and seeds. The comments urge FDA to revise the added 
sugars limit for protein foods to <=5% DV to accommodate nuts and 
seeds, which are commonly consumed as a snack food. The comments state 
that the <=5% DV baseline limit, in conjunction with the 0% DV limit on 
nuts and seeds, would force producers to either exclude

[[Page 106113]]

nuts and seeds from products or make other fundamental alterations. The 
comments express concern that some nutrient-dense protein foods, like 
peanut butter, which may contain small amounts of added sugars for 
palatability, could be excluded as a result of the strict 0% DV added 
sugars restriction. The comments note that nut butters are a 
nutritious, sustainable, shelf-stable, and economical source of 
protein. Some comments recommend that the added sugars limit for nuts 
and seeds should be <=5% of the DV for added sugars, consistent with 
the proposed limits for dairy products because dairy products are also 
sweetened to increase palatability.
    The comments suggest that that such stringent added sugars limits 
for fruits, vegetables, and protein foods could have unintended 
consequences. The comments suggest that the proposed 0% DV limit for 
these foods could promote increased use of ingredients such as polyols 
and other low or no calorie sweeteners, stating that a growing 
proportion of people are trying to avoid these types of ingredients. 
Furthermore, they argue that the proposed limits for these recommended 
foods could discourage their consumption or confuse consumers about the 
relative health value of these foods.
    (Response 78) We disagree that the proposed added sugars limit for 
fruits, vegetables, and protein foods would discourage their 
consumption since these foods are often consumed in their natural state 
without the addition of any sugars. For many years, dietary 
recommendations, including the Dietary Guidelines, have consistently 
recommended fruits, vegetables, and certain protein foods and limiting 
the consumption of sugar, so we also disagree that the proposed added 
sugars limit would be confusing to consumers. However, we recognize 
that small amounts of added sugars that are added to recommended foods 
through recipes and seasonings can enhance the flavor of fruits, 
vegetables, and protein foods and can have functional properties that 
go beyond palatability. Small amounts of sugars may also be added to 
fruits and vegetables for flavor standardization because of the 
variability in sugar content due to growing conditions. We are 
increasing the added sugars limit for fruits, vegetables, and protein 
foods to provide some flexibility for products containing foods from 
these food groups that are foundational to a healthy dietary pattern.
    We conducted a review of the products available in the marketplace 
to determine how much added sugars are typically included in individual 
fruit, vegetable, and protein foods, such as canned and frozen fruits 
and vegetables, and nut products, including different types of nut 
butters (Ref. 2). While we agree that requiring fruits, vegetables, and 
protein foods to contain no added sugars to qualify for the ``healthy'' 
claim would prevent some individual food products from these categories 
from bearing the claim, we disagree that a limit of 5% of the DV is 
appropriate. Many individual food products in these categories contain 
no added sugars and setting a limit of 5% of the DV per RACC could 
result in foods that contain more added sugars than necessary bearing 
the ``healthy'' claim, when the ``healthy'' limits are intended to help 
consumers identify foods that are particularly useful in achieving a 
healthy dietary pattern. Small amounts of added sugars contributed by 
different foods in the diet add up over the course of the day and can 
make it difficult for an individual to meet nutrient needs without 
exceeding the amount of calories they need in a day for weight 
maintenance (81 FR 33742 at 33759). We looked at the added sugars 
content of specific fruit, vegetable, and protein food products 
mentioned in comments (e.g., nut butters and fish with seasonings) and 
found that there are products of this type currently in the marketplace 
with less than or equal to 5% of the DV for added sugars.
    Furthermore, many of the MyPlate kitchen recipes incorporating 
fruits and vegetables with amounts of added sugars of 5-10% of the DV 
are mixed products, meals, and main dishes rather than individual 
foods. As previously mentioned, we are increasing the added sugars 
limits for mixed products, meals, and main dishes to provide more 
flexibility in the formulation of those products. Based on our 
consideration of the different purposes and functions of added sugars 
in different foods, including texture, flavor standardization; use in 
seasonings, sauces, and other ingredients in the formulation of 
recipes; consistency with the Dietary Guidelines, 2020-2025; and our 
marketplace review of nutrient-dense foods, we are finalizing an added 
sugars limit for individual fruits, vegetables, and protein foods of 
<=2% of the DV (currently <=1 g for adults and children 4 years of age 
and older) per RACC (or per 50 g for foods with RACCs 50 g or less or 3 
Tbsp or less), which will provide for the addition of small amounts of 
added sugars without resulting in products that contain unnecessary 
amounts of added sugars being able to bear the ``healthy'' claim.
    Many products mentioned in comments, such as frozen fruit and grain 
bowls, frozen vegetable grain bowls, frozen plant-based patties, and 
some fresh, bagged salads with dressing and toppings, could be 
considered mixed products or main dishes, depending on their 
formulation. Products that only contain enough of one of the 
recommended food groups to bear the claim (e.g., a bag of salad with 
only salad dressing) would be considered to be individual foods. The 
increased added sugars limit for individual fruits, vegetables, and 
protein foods, as well as the increased limit for grains (discussed 
below), provide more flexibility for the types of products mentioned in 
comments that contain small amounts of added sugars but can still be 
foundational to a healthy dietary pattern. The increased added sugars 
limit also decreases the likelihood that manufacturers will add polyols 
and low- and no-calorie sweeteners to fruits, vegetables, and protein 
foods.
    (Comment 79) One comment provides that, while the DGAC Report 
recommended a limit for added sugars in foods, there was 
acknowledgement that foods containing small amounts of added sugars can 
be part of a healthy diet. The comment supports FDA's proposal that 
100% juices eligible to bear the ``healthy'' claim contain 0% added 
sugars, but also advocates that juice drinks containing a small amount 
of added sugars should be considered ``healthy.''
    (Response 79) We disagree that, in general, juice drinks containing 
small amounts of added sugars should qualify to bear the ``healthy'' 
claim. The Dietary Guidelines consider juice drinks to be sugar-
sweetened beverages. Sugar-sweetened beverages are one of the major 
sources of added sugars in the typical U.S. diet, contributing 
approximately 24% of added sugars to the diets of adults and children 1 
year and older (Ref. 1 Figure 1-10). The Dietary Guidelines includes 
100% fruit juices, but not juice drinks containing added sugars, in the 
fruit group. Furthermore, the Dietary Guidelines for Americans, 2020-
2025 says that when juices are consumed, they should be 100% juice or 
100% juice diluted with water (without added sugars). Juice drinks 
often contain juices from fruits that are naturally sweet, and 
therefore, allowing juice drinks to contain added sugars could result 
in juice drinks with unnecessary excess sugars qualifying to bear the 
``healthy'' claim. In addition, as stated above, small amounts of added 
sugars contributed by different foods in the diet add up over the 
course of the day and can make it difficult for an individual to meet 
nutrient needs

[[Page 106114]]

without exceeding the amount of calories they need in a day for weight 
maintenance (81 FR 33742 at 33759). For these reasons, we decline to 
revise the rule so that juice drinks containing even small amounts of 
added sugars could qualify for the ``healthy'' claim.
    (Comment 80) A number of comments raise concerns that the added 
sugars limit of zero g for the fruit group would prevent tart fruit 
products, (e.g., dried cranberries, dried tart cherries, and cranberry 
juice drinks), and, in particular, cranberries and tart cherries, from 
bearing the ``healthy'' claim. The comments explain that cranberries 
and tart cherries have a lower natural sugar content than most other 
fruits, necessitating added sugars for palatability. The comments 
assert that the proposal unfairly disadvantages tart fruit products and 
would discourage Americans from consuming these nutrient-dense fruits. 
The comments also posit that the added sugars limit, in conjunction 
with the proposed FGE criteria, would mislead consumers to believe that 
such products are unhealthy because they do not bear a ``healthy'' 
claim. One comment argues that, from a First Amendment perspective, FDA 
has ignored a number of less restrictive means to achieve its goals, 
including the comment's proposed modified criteria for lower sugar 
fruits such as cranberries. The comments also express concern over the 
financial impact on cranberry and tart cherry farmers if such products 
are not eligible to bear the ``healthy'' claim due to their added 
sugars content.
    The comments note that products that compete with cranberry and 
tart cherry products in the marketplace, such as raisins and dried 
apples, have a similar or higher total sugar content and would be 
permitted to make the claim. The comments state that the added sugars 
in dried cranberries and tart cherries do not result in more total 
calories than comparable foods. They assert that the body's response to 
sugars does not depend on whether they are naturally present or added 
to foods. The comments also note that reduced sugar dried cranberries 
have less sugar and more fiber compared to other dried fruits.
    The comments assert that cranberry and tart cherry products are 
nutritious and contain bioactive components. The comments explain that 
such products are high in nutrients, such as vitamins A and C as well 
as in copper and flavanoids. The comments highlight that USDA currently 
promotes consumption of cranberry products, despite their added sugar 
content, and raise concerns that the proposed added sugars limit 
undercuts the nutritional contribution that dried cranberries, 
cranberry juice, and tart cherry products make to healthy dietary 
patterns.
    Some comments advocate for a framework that would allow cranberry 
products, including sweetened dried cranberries, that meet fruit FGE 
criteria and sodium and saturated fat limits, but contain added sugars 
for palatability in an amount that does not exceed the total sugar 
content of similar fruit products, to bear the ``healthy'' claim. The 
comments similarly support either an exemption for tart cherries from 
the added sugars limit or say that the added and natural sugar limits 
should be standardized for all fruits without exception. The comments 
ask that, if we do not change our position on the added sugars limits 
for tart fruits, we delay implementation of the final rule for 5 years 
to give the industry time to use its inventory of previously printed 
labels and work to procure new labeling as well as to conduct research 
regarding added sugars in tart cherries.
    Some comments also oppose the exclusion of cranberry and tart 
cherry juice products from using the ``healthy'' claim simply because 
they do not meet fruit equivalent requirements and contain added 
sugars. The comments provide information about the health benefits of 
27% cranberry juice drink and argue that consumers need to consume less 
cranberry content compared to the content of other fruit juices to 
receive the healthful benefits from polyphenol bioactives contained in 
cranberries. The comments also note that FDA issued a letter of 
enforcement discretion for a qualified health claim regarding the 
relationship between cranberry juice beverages containing at least 27% 
cranberry juice (8 fluid oz) and risk reduction of recurrent urinary 
tract infections in healthy women. The comments suggest that if we 
proceed with the proposed definition of ``healthy,'' it could lead 
consumers to switch to apple juice, orange juice, or grape juice from 
cranberry juice.
    (Response 80) We agree that cranberries and tart cherries are 
examples of naturally tart fruits to which manufacturers often add 
sugar to increase palatability. The comments and our review of products 
in the marketplace demonstrate that many cranberry and tart cherry 
products provide amounts of total sugars that are less than or 
equivalent to comparable fruit products. We recognize that cranberry 
and tart cherry products, because of their nutrient composition, are 
particularly useful in building a healthy dietary pattern (although the 
qualified health claim and any other health benefits not directly 
related to nutrient content mentioned by the comments are not relevant 
here). Therefore, we intend to consider the exercise of our enforcement 
discretion for the added sugars limit for cranberry and tart cherry 
products that meet fruit FGE criteria and meet the nutrient limits for 
sodium and saturated fat, but contain added sugars for palatability in 
an amount that is no greater than the amount of total sugars in 
comparable products with endogenous (inherent) sugars but no added 
sugars (e.g., unsweetened raisins, 100% grape juice). We consider a 
``comparable product'' to be one that is in the same food category 
(e.g., fruit), that is in the same form (e.g., dried), and that has the 
same usage (e.g., snack). For example, we consider unsweetened raisins 
to be comparable to sweetened dried cranberries and sweetened dried 
cherries and unsweetened 100% grape juice to be comparable to a 
sweetened 27% cranberry juice drink.
    Additionally, we intend to exercise enforcement discretion for the 
inclusion of the added sugars contribution from cranberry and tart 
cherry ingredients in mixed products that meet the FGE criteria and the 
nutrient limits for sodium and saturated fat, but the cranberry and 
tart cherry ingredients contain added sugars for palatability in an 
amount that is no greater than the amount of total sugars in comparable 
products, as previously described. For example, under this enforcement 
discretion policy, the added sugars contributed by dried cranberries in 
a trail mix that meets the FGE criteria and nutrient limits for mixed 
products would not count towards the added sugars limit for the product 
when the added sugars in the dried cranberries are in an amount that is 
no greater the amount of total sugars in a comparable product with 
endogenous sugars (e.g., raisins).
    At this time, we do not intend to exercise enforcement discretion 
for other tart fruit products. Based on the information that we have 
received in response to the requirement for mandatory declaration of 
added sugars on the Nutrition Facts label and the proposed added sugars 
limits for the use of the ``healthy'' implied nutrient content claim, 
cranberry and tart cherry products are uniquely impacted by the added 
sugars labeling requirements. They are at a competitive disadvantage in 
the marketplace compared to other comparable foods that naturally have 
the same amount of total sugars (e.g., raisins, grape juice).
    We are not aware that there are other tart fruits that are at a 
competitive

[[Page 106115]]

disadvantage because products made with those fruits require sugars for 
palatability at an amount that is comparable to other fruit products 
with natural sugars. Furthermore, many products made with other tart 
fruits (e.g., lemonade and limeade) are made with far less juice or 
fruit and more sugar and water than cranberry and tart cherry products.
    For the reasons previously mentioned, we are only providing 
enforcement discretion for cranberry and tart cherry products at this 
time, but could consider remedies for other tart fruit products if we 
become aware of additional information demonstrating that they are 
similarly situated. As with any intent to exercise enforcement 
discretion, FDA may update the exercise of enforcement discretion, 
consistent with FDA's good guidance practices (21 U.S.C. 371(h), 21 CFR 
10.115).
    (Comment 81) Many comments express concern that the proposed limit 
on added sugars for grains would prevent many whole grain foods from 
bearing a ``healthy'' claim and generally make it difficult for 
consumers to make healthy dietary choices. The comments say that added 
sugars are used to make nutrient-dense foods, including whole grains, 
more palatable. They suggest that the addition of moderate amounts of 
added sugars can increase consumption of whole grains, which are 
currently underconsumed in the United States, and promote more 
healthful dietary patterns. The comments suggest increasing the added 
sugars limit for grains (e.g., to 10%, 20% or 25% of the DV for added 
sugars).
    The comments say that more than 95% of the major ready-to-eat 
breakfast cereal products on the market and most whole grain breads 
will not qualify due to the added sugars criteria. The comments note 
that, among the general population, ready-to-eat cereal eaters have 
higher intakes of several nutrients, including the nutrients of public 
health concern, such as calcium, vitamin D, and fiber, than those who 
do not eat ready-to-eat cereal. In addition, the comments cite data 
from the National Health and Nutrition Examination Survey 2017-2018, 
which they say shows that ready-to-eat cereal is the number one 
contributor of fiber in children's diets and ready-to-eat cereal is a 
top source of whole grain for all Americans 2 years of age and older. 
The comments note that ready-to-eat cereal is an affordable and 
accessible choice because it is a shelf-stable food that can be found 
in small stores in big cities, large supermarkets, and online. The 
comments cite data showing that the intake of nutrients of public 
health concern was significantly higher among low-income ready-to-eat 
cereal eaters compared to low-income non-eaters. Some comments argue 
that the proposed <=5% DV added sugars limit for breakfast cereal is 
too low and suggest that consumers will add more sugars on their own if 
limits are set too low. Some comments recommend increasing cereal 
products' added sugars limits from 5% of the DV to 10% of the DV to 
reflect their delivery of whole grains and essential nutrients and 
their typical consumption as a main dish.
    (Response 81) Most Americans meet recommendations for total grain 
intakes, but 98 percent fall below recommendations for whole grains and 
74% exceed limits for refined grains (Ref. 1). The Dietary Guidelines 
for Americans, 2020-2025 recommends that grain-based foods in nutrient-
dense forms limit the additions of added sugars, saturated fat, and 
sodium. It also notes that that limited amounts of added sugars can be 
used to make some grain-based foods more palatable while staying within 
calorie and nutrient limits, but most grains should be eaten in their 
most nutrient-dense forms.
    In response to these comments, we conducted a review of the 
products available in the marketplace to look more closely at the added 
sugars content of whole grain products, such as ready-to-eat cereals, 
hot cereals, whole grain breads, and whole grain crackers (Ref. 2). Our 
marketplace review of the added sugars content of whole grain breads 
and crackers showed that there are many whole grain breads and crackers 
that contain <=5% of the DV for added sugars, including whole grain 
options for breads, pita bread, English muffins, hotdog and hamburger 
rolls, naan, flatbreads, pizza crusts, tortillas, and crackers, and 
therefore, would qualify to use of the ``healthy'' claim. While we did 
not find that 95% of ready-to-eat cereals would be ineligible for the 
``healthy'' claim based on the proposed added sugars limit, the 
proposed added sugars limit does significantly limit the number of 
whole grain cereal products, as well as the variety of whole grain 
foods that would qualify for the claim. There is a wide distribution in 
terms of the added sugars content of whole grain breakfast cereals 
(ranging from 0 g/serving to 22 g/serving). Increasing the added sugars 
limit from <=5% of the DV for added sugars to <=10% of the DV for added 
sugars would result in more, and a wider variety of, whole grain 
cereals, which are encouraged in the Dietary Guidelines as sources of 
important nutrients, as well as a wider variety of whole grain foods 
being able to bear the claim.
    However, increasing the added sugars limit to >=10% of the DV for 
added sugars would not reflect the Dietary Guidelines recommended 
shifts towards nutrient dense forms of all grains, including ready-to-
eat breakfast cereals, that are recommended in the Dietary Guidelines, 
and could result in whole grain foods, such as breads and crackers, 
with excess added sugars, qualifying to bear the ``healthy'' claim. We 
recognize that ready-to-eat cereals can be an important source of 
nutrients to the diet because most are fortified. However, the Dietary 
Guidelines for Americans, 2020-2025 notes that grains are generally 
consumed in forms with higher amounts of sodium and added sugars (e.g., 
grain-based desserts, many ready-to-eat breakfast cereals) rather than 
the nutrient-dense forms and recommend shifting to more nutrient-dense 
forms of grains, such as ready-to-eat breakfast cereals with less sugar 
to help meet healthy dietary patterns.
    After further consideration of the added sugars limit for grain 
products and the comments received on this topic, we find, based in 
part on the recommendations in the Dietary Guidelines, 2020-2025 for 
whole grains that suggest that limited amounts of added sugars can be 
included to increase palatability and the availability of nutrient-
dense whole grain cereals in the marketplace, that increasing the added 
sugars limit from <=5% of the DV to <=10% of the DV would result in 
more nutrient-dense whole grain products encouraged by the Dietary 
Guidelines, such as whole grain cereals with less sugar, being able to 
bear the claim, and would allow manufacturers to use the ``healthy'' 
claim on a wider variety of whole grain products, which are 
underconsumed in the United States. Therefore, we are finalizing an 
added sugars limit of <=10% of the DV per RACC for added sugars 
(currently <=5 g for adults and children 4 years of age and older) for 
whole grains.
    With respect to comments that suggest that consumers will add more 
sugars on their own if the added sugars limits for the ``healthy'' 
claim are too low and that the added sugars limits need to be increased 
to 10% of the DV for added sugars because cereal products are typically 
consumed as a main dish, the ``healthy'' claim is a voluntary nutrient 
content claim that does not prescribe how or when a consumer would 
consume a food or what they would add to their food. Regardless of what 
the added sugars limit is for products bearing the claim, consumers may 
choose to add sugars to their food, and they may choose to consume 
cereal alone or with other foods as part of a

[[Page 106116]]

snack or meal. Main dishes must contain foods from at least two 
qualifying food groups with no less than \1/2\ FGE from either of the 
two food groups and a total of two FGEs. If a cereal product meets the 
FGE requirements and other requirements for the use of the ``healthy'' 
claim as a main dish, it could also qualify based on the added sugars 
limit for main dishes (<=15% of the DV for added sugars), which is 
higher than the limit for individual foods, which are now able to 
contain <=10% of the DV for added sugars.
    (Comment 82) Specifically referring to dairy, some comments support 
the proposed added sugars limit for dairy of <=5% of the DV. The 
comments say that dairy products should not be permitted to have higher 
limits because dairy products are often sweetened. The comments also 
say that, although sugars are often added to dairy products, many dairy 
products do not contain added sugars and do not need them for 
palatability. The comments recommend against allowing any flavored milk 
to bear the ``healthy'' claim, citing data from the School Nutrition 
and Meal Cost Study showing the main source of added sugars in both 
school breakfasts and school lunches was flavored fat-free milk. The 
USDA School Nutrition and Meal Cost Study is a nationally 
representative assessment of the school meal programs (Ref. 40). The 
comments say that encouraging children to drink beverages with no added 
sugars is a goal of the Dietary Guidelines, which would be supported by 
only allowing the ``healthy'' label to be used on unflavored rather 
than flavored milk.
    Conversely, other comments urge FDA to consider allowing a 
reasonable increase in sugar content because a moderate amount of sugar 
increases palatability of dairy foods that provide essential nutrients. 
The comments suggest a 10% added sugars limit for dairy products, 
because they assert that the addition of added sugars is necessary to 
increase the palatability of dairy and encourage consumption of 
nutrient-dense dairy products. The comments argue that flavored milks 
and yogurts are a nutrient-dense source of vitamins, minerals, and 
protein and that flavored varieties of dairy products encourage more 
consumption of these foods across the population that is underconsuming 
dairy. The comments note that companies have already been working to 
reformulate their products to include lower sugar options following the 
publication of the NFL Final Rule; however, if the added sugars limit 
for products to qualify for the ``healthy'' claim is set too low, the 
comments state that further reformulation will be impractical and 
undesired by consumers, and therefore, companies will be less likely to 
undertake reformulation.
    The comments also argue that, according to the Dietary Guidelines 
2020-2025, nearly two-thirds of all energy from added sugars in the 
average American diet is coming from sugar-sweetened beverages, 
sweetened coffees and teas, desserts and sweet snacks, and candies and 
sugars. In contrast, dairy foods contribute only 4% of total added 
sugars to the average American diet, and yogurt contributes less than 
2%. The comments argue that beverages make up a large proportion of a 
child's caloric intake and, therefore, the current Dietary Guidelines 
recommend that beverages also need to be evaluated in light of both 
overall calories and available nutrient content. The comments suggest 
that milk can help fulfill these two elements while other beverages 
cannot.
    Other comments suggest that FDA has not provided adequate 
scientific rationale to support or justify the proposed added sugar 
limit for dairy foods at 5% of the DV/RACC. The comments assert that 
the proposed limits for dairy would encourage the use of alternative, 
non-nutritive sweeteners that have not been proven to aid in weight 
management in the long term. The comments recommend increasing the 
added sugars limit to at least 10% DV per c-eq for dairy products.
    Many comments urge FDA to increase the added sugars limit for 
yogurts, stating that a certain amount of sweetness is needed to offset 
the naturally tart taste of yogurt. One comment says that, according to 
their analysis of Nielson Label Insight data, the proposed added sugars 
limit would prevent 72% of yogurts, including low-fat and fat free 
yogurts from bearing the ``healthy'' claim. The comment argues that 
disqualification of most low-fat and fat-free yogurts with moderate 
amounts of added sugar from bearing the ``healthy'' claim will further 
jeopardize Americans' consumption of dairy foods and may engender a 
false perception that yogurts are not healthy. Another comment asserts 
that the science does not support limiting intake of core foods that 
contain added sugars, such as flavored yogurt and milk. The comment 
points to a recent study showing that yogurt consumers had higher diet 
quality and higher percent of the population meeting recommended 
intakes for calcium, magnesium, and potassium than non-consumers (Ref. 
29). The comments say that such a low limit for added sugars would 
force more yogurt manufacturers to sweeten their yogurts with low and 
no calorie sweeteners.
    (Response 82) The definition of nutrient-dense foods and beverages 
provided in the Dietary Guidelines for Americans 2020-2025 includes 
fat-free and low-fat dairy products, when prepared with no or little 
added sugars, saturated fat, and sodium (Ref. 1). The Dietary 
Guidelines for Americans, 2020-2025 note that most Americans are not 
consuming enough dairy and suggest that strategies to increase dairy 
intake include drinking fat-free or low-fat milk or a fortified soy 
beverage with meals or incorporating unsweetened fat-free or low-fat 
yogurt into breakfast or snacks. There is no mention of flavored milks, 
flavored yogurts, or other flavored dairy products or plant-based dairy 
alternatives as recommended foods. Further, the Dietary Guidelines for 
Americans, 2020-2025 recommend that beverages that contain no added 
sugars should be the primary choice for children and adolescents. It 
notes that consuming beverages with no added sugars is particularly 
important for young children ages 2 through 8, when only a small number 
of calories remains for other uses after meeting food group and 
nutrient needs with nutrient-dense choices. Unsweetened fat-free and 
low-fat milk, including low-lactose or lactose free options or 
fortified soy beverages are among the beverages recommended for 
children and adolescents in the Dietary Guidelines.
    We disagree that the study cited in the comment is sufficient to 
determine that science does not support limiting intake of added sugars 
from dairy products such as yogurt and flavored milk. As discussed 
previously, the Dietary Guidelines, as well as consensus reports from 
authoritative bodies, and their nutrition science underpinning, help 
FDA to shape regulations on nutrition-related claims and other 
information that is on a food label. We rely on these sources of 
information because the reflect expert review and recommendations based 
on the body of nutrition evidence rather than findings from one 
individual study, which may not reflect the larger body of evidence.
    While we are including dairy products with small amounts of added 
sugars added to increase their palatability in the foods that qualify 
for the ``healthy'' claim, including dairy products with significant 
amounts of added sugars would not be consistent with the Dietary 
Guidelines for Americans, 2020-2025, which recommends consumption of 
the most nutrient-dense forms of foods and specifically encourages 
consumption of

[[Page 106117]]

unsweetened fat-free and low-fat dairy products (e.g., milk and yogurt) 
as nutrient-dense options in the dairy group. In response to the 
comments, we conducted a marketplace review to look at added sugars 
content of dairy products, including milk products, yogurts, and plant-
based dairy alternatives (Ref. 2). Unlike the grains group, where 
relatively few products in certain product categories, such as ready-
to-eat cereals, would meet the proposed added sugars limit, we found 
that the majority of dairy products (approximately 73%) contained 0 g 
of added sugars per serving and most unflavored dairy products across 
all dairy product categories, as well as approximately 32% of yogurts 
and 9% of flavored milks, could meet the proposed limit of <=5% of the 
DV for added sugars. Given that there are many dairy products currently 
on the market that could meet the proposed added sugars limit, 
including a significant number of yogurts and even some flavored milk 
products, and in keeping with the recommendations and strategies for 
reducing consumption of added sugars discussed in the Dietary 
Guidelines, 2020-2025, including the specific recommendation 
encouraging consumption of unsweetened dairy products, as well as the 
purpose of the ``healthy'' nutrient content claim, we are finalizing 
the added sugars limit of <=5% of the DV per RACC (currently <=2.5 g/
RACC for adults and children 4 years of age and older) for dairy 
products.
    (Comment 83) Some comments express concern about the application of 
the proposed added sugars limit to plant-based dairy alternatives. The 
comments say that, to approximate the natural sweetness of dairy or to 
feed the microbes responsible for creating yogurt, sugar is sometimes 
required in modest amounts to create alternative dairy products with 
similar culinary attributes to conventional dairy products. The 
comments also say that the enzymatic hydrolysis process used to create 
some oat milk products breaks down starches naturally occurring in oats 
into sugars. Some comments support added sugars limits for plant-based 
dairy alternatives that are consistent with those of cow's milk dairy 
products. Some comments suggested that higher levels of added sugars 
are necessary in plant-based dairy alternatives in comparison to other 
dairy products while others suggested that the same added sugars limits 
should be applied for dairy and plant-based dairy alternatives. The 
comments also argue that plant-based dairy alternatives, such as oat 
beverages, must declare sugars created through enzymatic hydrolysis as 
added sugars on the Nutrition Facts label, and, therefore, the proposed 
added sugars limits would prevent such products from bearing the 
``healthy'' claim, while cow's milk products that contain added sugars 
could bear the claim. Some comments suggest that, in the case of 
alternative dairy products containing sugars solely as a result of 
enzymatic or microbial activity and no other added sugar, such products 
should be eligible to bear a ``healthy'' claim if they contain less 
sugar than 1 cup of unsweetened cow's milk, contribute significant 
nutrients of value, and do not exceed the saturated fat and sodium 
limits per RACC for dairy.
    (Response 83) With respect to sugars added to plant-based milk 
alternative products through enzymatic hydrolysis, we said in our 
guidance regarding declaration on the Nutrition Facts label (Ref. 30) 
that, for the added sugars declaration on the label, we consider sugars 
created through the hydrolysis of starch or other complex carbohydrates 
inherent to grains, such as oats or rice, to be the same as sugars 
created through the hydrolysis of starch in the production of 
ingredients, such as maltodextrins, because in both cases, sugars are 
created through controlled hydrolysis. Because the hydrolysis process 
is controlled, manufacturers can determine the amount of sugars created 
and present in the final product. We said that we considered the sugars 
created through controlled hydrolysis in the production of plant-based 
beverages to provide empty calories to the diet. Although many plant-
based beverages created through controlled hydrolysis contain sugars 
created through that process (that are considered added sugars for the 
purposes of the Nutrition Facts label) in amounts similar to the total 
sugars content of unflavored cow's milk, we are aware that there are 
such products in the marketplace that are unsweetened, contain no added 
sugars, and therefore do not contribute empty calories from added 
sugars to the diet. We do not have data or information about whether 
and how much added sugars may be necessary in plant-based dairy 
alternatives to approximate the taste of dairy, to feed microbes in the 
creation of plant-based yogurt alternatives, or to break down starches 
into sugars, and the comments that argued for this adjustment did not 
provide such data or information. Therefore, we do not have a basis to 
set a different added sugars limit for plant-based dairy alternatives, 
and so we also decline to provide an exemption from the added sugars 
limit for the sugars created through controlled enzymatic hydrolysis in 
the creation of plant-based beverages.
    (Comment 84) One comment urges us to permit liquid oil-based 
dressings containing up to 6% of the DV (3 g) of added sugars per RACC 
rather than the proposed limit of <=2% (currently <=1 g for adults and 
children 4 years of age and older). The comments say that the sugars in 
oil-based dressings play a role in making nutritious leafy greens and 
other vegetables in salads tastier. The comments also note that the 
Dietary Guidelines for Americans, 2020-2025 states that a limited 
amount of added sugars can be included as part of an overall healthy 
eating pattern that includes healthy choices from each of the food 
groups.
    (Response 84) The comment did not provide any data or other 
information to support changing the added sugars limit for oil-based 
dressings from 2% of the DV for added sugars to 6% of the DV for added 
sugars. There are many ingredients in oil-based dressings that can 
enhance the flavor of foods (e.g., the oil itself, herbs, and other 
seasonings) besides sugar. We reviewed products available in the 
marketplace and found that approximately 26% of oil-based dressings can 
meet the added sugars limit of 2% of the DV per 50 g. The Dietary 
Guidelines for Americans, 2020-2025 recommends limiting added sugars to 
no more than 10% of calories per day. As discussed in the NFL Final 
Rule, small amounts of added sugars add up throughout the course of the 
day (81 FR 33742 at 33759). Because oil-based dressings can contain 
multiple ingredients that can enhance the flavor of foods such as leafy 
green vegetables, there are many such products in the marketplace that 
meet the added sugars limit. Further, we are not aware of any data or 
information that would support a different limit that is greater than 
<=2% of the DV for added sugars. Therefore, we decline to change the 
added sugars limit for oil-based dressings and are finalizing the added 
sugars limits of 0% of the added sugars DV per RACC (or per 50 g if 50 
g or less or 3 Tbsp or less) for 100% oil and oil-based spreads and 
<=2% of the DV per RACC (or per 50 g if 50 g or less or 3 Tbsp or less) 
for oil-based dressings.
b. Low- and No-Calorie Sweeteners
    In the proposed rule (87 FR 59168 at 59180), we noted that we do 
not consider high-intensity (low- and no-calorie) sweeteners to be 
added sugars. Although we used the term ``high intensity sweeteners'' 
to describe sweeteners other than sugars and syrups

[[Page 106118]]

that are added to foods for sweetening purposes in the proposed rule, 
high intensity sweeteners are a subset of sweeteners that are many 
times sweeter than table sugar (sucrose). The comments discuss 
sweeteners that provide less calories than sucrose more broadly. 
Therefore, for the purpose of this final rule, we will refer to all 
sweeteners (e.g., ``high intensity sweeteners,'' ``nonnutritive 
sweeteners,'' ``sugars metabolized differently than traditional 
sugars,'' ``zero calorie sweeteners,'' sugar alcohols, etc.) that 
provide less calories than sucrose as ``low- and no- calorie 
sweeteners'' throughout rather than ``high intensity sweeteners.''
    (Comment 85) Some comments agree with FDA's position in the 
proposed rule that low-and no-calorie sweeteners are not a factor in 
determining whether a product meets the requirements for the use of the 
``healthy'' claim and support foods qualifying for the ``healthy'' 
claim that contain these ingredients. The comments note that the 
Dietary Guidelines for Americans, 2020-2025 emphasize that a healthy 
dietary pattern is one that is flexible and allows individuals the 
ability to adjust the recommendations to meet their personal 
preferences, cultural traditions, and budgetary restrictions. The 
comments state that allowing products containing low-and no-calorie 
sweeteners to bear the ``healthy'' claim will allow companies to offer 
a variety of healthy foods that appeal to consumers and help the reduce 
the amount of added sugars in their diets. The comments also state that 
science has determined the safety of low- and no-calorie sweeteners.
    Many comments opposing a ``healthy'' claim on products containing 
low- and no-calorie sweeteners express concern about the safety of low- 
and no-calorie sweeteners, including specific products such as 
aspartame, saccharin, sucralose, and acesulfame. They also question the 
validity of studies professing the safety of low- and no-calorie 
sweeteners, arguing that while sweeteners may have neutral effects on 
physical health, low- and no-calorie sweeteners can negatively impact 
health. They discuss individual studies on the impact on the 
microbiome, the association with neurophysiological symptoms such as 
headaches, migraines, and irritability, and suggest that low- and no-
calorie sweeteners are addictive and foster cravings that lead to the 
overconsumption of foods that are associated with metabolic diseases. 
Similarly, the comments argue that these sweeteners are metabolically 
active and lead to a number of complications including glucose 
intolerance.
    The comments express particular concern about the use of low- and 
no-calorie sweeteners in products marketed to children. The comments 
refer to a citizen petition from the Sugar Association (FDA-2020-P-
1478) regarding the labeling of products containing low- and no-calorie 
sweeteners, including requests related to the labeling of these 
sweeteners in foods and beverages consumed by children, which are 
outside the scope of this rule. The comments discuss statements from 
health professional organizations such as the American Academy of 
Pediatrics (Ref. 31) and the American Heart Association (Ref. 32) 
suggesting that the long-term safety of low- and no-calorie sweeteners 
in children has not been established.
    (Response 85) As explained in the preamble to the proposed rule, 
since 1994, we have recognized that labeling that describes a food 
product as ``healthy'' in a nutritional context is making an implicit 
claim of the level of nutrients in the product. This implied claim can 
be used to identify foods that are particularly useful in creating a 
diet that is consistent with current dietary recommendations. Based on 
current nutrition science and Federal dietary guidelines, we have 
included the NTL that further this goal--added sugars, saturated fat, 
and sodium. We agree that the ability of foods using the ``healthy'' 
claim to contain low- and no-calorie sweeteners can give manufacturers 
more flexibility in formulating foods to meet the requirements for the 
use of the claim and can provide consumers with more options to meet 
their needs and preferences.
    Further, we note that significant scientific evidence has shown 
that low- and no-calorie sweeteners are safe for consumption. Under the 
FD&C Act, such evidence is required to establish the safety of any 
substance intentionally added to food, whether it is a food additive 
requiring pre-market approval or is excepted from the definition of a 
food additive because it is generally recognized as safe (GRAS) under 
the conditions of its intended use. For every food additive petition 
for a low- or no-calorie sweetener, FDA assesses its safety under its 
intended conditions of use. When GRAS notices have been submitted for a 
low- or no-calorie sweeteners, FDA conducted an initial evaluation to 
determine whether to file it as a GRAS notice for evaluation of whether 
the notified substance (a low- or no-calorie sweetener in this case) is 
GRAS under the conditions of its intended use (see 21 CFR 
170.265(a)(1)). FDA also stays abreast of published literature and is 
aware that there are some new studies regarding consumptions of 
sweeteners by children and adolescents, but notes these studies have 
methodological challenges and are not conclusive. Based on the 
evaluation of existing evidence, including studies on the association 
of consumption of sweeteners in children and adolescents on various 
health outcomes, FDA has determined that the uses of sweeteners that 
are authorized by regulation are safe, and FDA had no questions 
regarding notifiers' GRAS conclusions for a variety of sweeteners. For 
more information about FDA's position on low- and no-calorie 
sweeteners, see FDA's published information about food additive 
petitions and GRAS notices (Ref. 33).
    Thus, to the extent that comments argue that low- and no-calorie 
sweeteners should not be permitted in foods bearing the ``healthy'' 
claim based on their health effects and their perceived impact on 
maintaining healthy dietary practices, based on the FDA determinations 
of safety, we do not have a basis for concluding that products bearing 
the ``healthy'' claim should not contain low- or no-calorie sweeteners 
due to any perceived impact on consumers' ability to maintain healthy 
dietary practices. We intend to continue to monitor the use of low- and 
no-calorie sweeteners and evidence related to their impact on health 
and, as appropriate, will update the nutrient content claim ``healthy'' 
as nutrition science evolves.
    (Comment 86) Some comments note the language in the Dietary 
Guidelines regarding the lack of certainty about the effectiveness of 
replacing added sugars with low- and no-calorie sweeteners as a long-
term weight management strategy and refer to guidance issued by the WHO 
on the use of non-sugar sweeteners that was based on a systematic 
review and meta-analysis on the health effects of non-sugar sweeteners 
conducted by the WHO (Refs. 1, 34, and 41). The comments claim that the 
guidance states that ``there is no clear consensus on whether non-sugar 
sweeteners are effective for long-term weight loss or maintenance, or 
if they are linked to other long-term health effects at intakes within 
the Acceptable Range.'' The comments call for more studies on the long-
term effects of low- and no-calorie sweeteners before it can be 
determined whether they contribute to a healthy dietary pattern. They 
also recommend that FDA monitor the marketplace to determine if 
manufacturers reformulate products

[[Page 106119]]

with low- and no-calorie sweeteners to meet the ``healthy'' criteria.
    (Response 86) Our determination that products containing low- and 
no-calorie sweeteners may use the ``healthy'' claim is not based on 
their association with weight loss or weight maintenance. Products may 
contain low- and no-calorie sweeteners for a variety of reasons, 
including to replace sugars, which can cause dental caries and impact 
blood glucose levels. We previously discussed that we have determined 
that low- and no-calorie sweeteners evaluated by FDA are safe, and we 
do not have a basis to exclude products containing low-and no-calorie 
sweeteners from bearing the claim. However, we do intend to monitor the 
use of low- and no-calorie sweeteners and evidence related to their 
impact on health.
    (Comment 87) Some comments recommend that sugars, such as D-
tagatose and isomaltulose, are metabolized differently than traditional 
sugars, and should be excluded from the definition of added sugars for 
the purpose of the ``healthy'' claim. One comment notes that many foods 
in which traditional sugars are replaced with isomaltulose may bear a 
health claim about the reduction in risk of dental caries, and it could 
be confusing to consumers if such a product could not bear the 
``healthy'' claim yet another food containing a similar amount of 
traditional sugar that does promote dental caries could bear the 
``healthy'' claim.
    (Response 87) We disagree with comments asserting that FDA should 
not consider D-tagatose and isomaltulose as added sugars for the 
purpose of the ``healthy'' nutrient content claim. We concluded in the 
NFL Final Rule that because D-tagatose and isomaltulose are chemically 
sugars, and other substances are included or excluded from the 
definition of sugars and added sugars based on whether they are free, 
mono-, or disaccharides rather than on their physiological effects. 
Including D-tagatose and isomaltulose in the declaration of added 
sugars is consistent with how we have characterized other sugars (81 FR 
33742 at 33837).
    With respect to the comment suggesting that consumers would be 
confused if a product containing traditional sugars can bear a 
``healthy'' claim yet a product bearing the health claim related to 
isomaltulose and a reduced risk of dental caries is not able to bear 
the claim, we disagree. As discussed in section V.H (``Nutritional 
Context''), the ``healthy'' nutrient content claim is different from a 
health claim. The ``healthy'' nutrient content claim suggests that a 
food, because of its nutrient content, is particularly helpful in 
building a healthy dietary pattern, whereas a health claim discusses 
the relationship between a substance and a disease or health related 
condition. The fact that a food may bear a health claim about a 
specific relationship between a substance and a disease or health 
related condition does not mean that the food is particularly useful in 
building a healthy dietary pattern consistent with dietary 
recommendations. As such, products containing D-tagatose or 
isomaltulose must meet the added sugars limit to bear the ``healthy'' 
claim.
    (Comment 88) Some comments suggest that American consumers would be 
unlikely to trust a ``healthy'' label on products that include low- and 
no-calorie sweeteners and request that the definition of ``healthy'' 
include a required disclosure that products contain low- and no-calorie 
sweeteners on the front of the label.
    (Response 88) As for the comments claiming that consumers will not 
trust products containing low- and no-calorie sweeteners bearing a 
``healthy'' claim, we do not have evidence to suggest that this outcome 
is possible or likely. We do note, however, that the criteria for a 
``healthy'' claim are based on the foods' contribution of nutrients to 
a healthy dietary pattern that help consumers in maintaining healthy 
dietary practices. Therefore, we decline to change our position on low- 
and no-calorie sweeteners.
    (Comment 89) Some comments suggest that restrictive added sugars 
limits could incentivize the increased use of low- and no-calorie 
sweeteners in fruits, vegetables, protein food groups (including the 
nuts and seed subgroup) and express opposition to nutrition policy that 
would expand broad use of these ingredients. Likewise, the comments 
express concern with the growing number of new products containing low- 
and no-calorie sweeteners and suggest that the proposed rule could 
result in the increased use of low- and no-calorie sweeteners and other 
highly processed ingredients, instead of natural products such as 
honey.
    Similarly, some comments assert that an allowance for low- and no-
calorie sweeteners would lead consumers away from choosing products 
with naturally occurring sugars. These comments argue that allowing 
sweetener-enriched products to bear the ``healthy'' claim would lead to 
increased use of ``highly processed'' low- and no-calorie sweeteners, 
which would negatively impact the sugar industry.
    Some comments also oppose including any products with low- and no-
calorie sweeteners in the ``healthy'' definition on the grounds they 
would train consumers' palates to expect unhealthy food more often that 
could lead to overconsumption. They say that a main driver of excessive 
food intake is the desire to experience reward, even when calorically 
satiated, and sweet taste, whether caloric or not, is highly rewarding. 
The comments also argue that children are particularly sensitive to the 
rewarding effects of sweet taste, asserting that taste preferences are 
formed at an early age.
    (Response 89) We do not know whether and how manufacturers may 
voluntarily reformulate their products to meet the requirements for the 
use of the ``healthy'' claim, and we also do not have evidence 
regarding how consumers will respond to any such changes in the 
marketplace. ``Healthy'' is a voluntary nutrient content claim that is 
used to identify foods that are foundational to a healthy dietary 
pattern, and products containing low- and no-calorie sweeteners would 
be an even smaller subset of the foods in the market that qualify to 
bear the ``healthy'' claim. Consumers are motivated by a variety of 
factors when choosing foods to purchase and consume (e.g., taste, 
appearance, mouthfeel, etc.). We are not aware of any evidence that the 
ability of products bearing the ``healthy'' claim to contain low- and 
no-calorie sweeteners would lead consumers away from choosing products 
with naturally occurring sugars.
    The added sugars limits are set to help consumers to identify foods 
that are particularly useful in helping the build healthy dietary 
patterns--nutrient-dense foods with limited amounts of added sugars. 
However, as discussed above, we have increased the added sugars limits 
for many individual food groups and subgroups, as well as for mixed 
products, main dishes, and meals (see section V.E (``Combination 
Foods'')), which will result in more nutrient-dense products sweetened 
with some traditional sugars being able bear the claim. (See Response 
78 for additional discussion about the added sugars limit and low- and 
no-calorie sweeteners in the fruits, vegetables, and protein food 
groups.)
    Thus, the final rule does not prevent the use of low- and no-
calorie sweeteners in products bearing the ``healthy'' claim. However, 
we intend to continue to monitor the use of low- and no-calorie 
sweeteners and the evidence related to their impact on health.

[[Page 106120]]

5. Nutrients Not Included
a. Total Fat
    (Comment 90) Some comments support FDA's proposal that total fat 
not be included in the ``healthy'' criteria and confirmed our assertion 
that this approach would be consistent with current nutrition science, 
the Dietary Guidelines, 2020-2025, and the updated Nutrition Facts 
label. One comment also notes that not having a total fat limit is 
consistent with FDA's 2016 enforcement discretion guidance for the 
``healthy'' nutrient content claim, relative to foods that are not low 
in total fat but have a fat profile consisting predominantly of mono- 
and polyunsaturated fat. Some comments discuss the adverse consequences 
of having a total fat limit in the original definition, such as the 
exclusion of foods that are high in unsaturated fats. The comments 
noted that, by not having a total fat limit, the rule would allow the 
claim on foods (e.g., fish, avocados, nuts and seeds, and certain oils) 
that are sources of mono- and polyunsaturated fats, which are important 
components of healthy dietary patterns.
    (Response 90) We agree that not including a total fat limit, while 
maintaining a saturated fat limit, is consistent with current nutrition 
science, the Dietary Guidelines, 2020-2025, and the updated Nutrition 
Facts label. This approach will also result in foods that are sources 
of unsaturated fats being able qualify for the claim.
b. Trans Fat
    (Comment 91) Several comments agree with our proposal to not 
include trans fat limits as part of the updated criteria for the 
``healthy'' nutrient content claim, noting that the primary dietary 
source of industrially-produced trans fat, PHOs, are no longer 
considered to be GRAS and have largely been removed from the food 
supply and the saturated fat limits should adequately address other 
sources of trans fat aside from PHOs (e.g., trans fat from ruminant 
products). One comment states that the science does not support an 
additional limit for trans fat on top of the saturated fat limit. In 
contrast, another comment recommends having a trans fat limit as part 
of the updated criteria for the claim; the comment mentions that 
studies have shown a positive association between trans fat intake and 
CVD risk and expresses the view that trans fat provides little to no 
nutritional benefit.
    (Response 91) We agree that trans fat has adverse effects on CVD 
risk; however, the comment does not provide any data or information 
showing that the proposed saturated fat limits would not adequately 
address products in the marketplace containing trans fat, particularly 
since PHOs are no longer considered GRAS and have largely been removed 
from the food supply. We note that, in the Federal Register of December 
14, 2023 (88 FR 86580), FDA published a notice confirming the effective 
date of a direct final rule amending our regulations to no longer 
provide for the use of PHOs in food given our determination that PHOs 
are no longer GRAS. The rule also revokes prior sanctions (i.e., pre-
1958 authorization of certain uses) for the use of PHOs in margarine, 
shortening, and bread, rolls, and buns based on our conclusion that 
these uses of PHOs may be injurious to health. Therefore, we decline to 
change our approach for trans fat, and the final rule does not include 
a limit for trans fat as part of the updated ``healthy'' criteria.
    (Comment 92) One comment requested that FDA require any amount of 
trans fat to be listed on food labels.
    (Response 92) The amount of trans fat required for the declaration 
of trans fat on food labels is outside of the scope of this rule. We 
note, however, that the NFL Final Rule and our label regulation at 
Sec.  101.9(c)(2)(ii) does require disclosure of trans fat as part of 
the Nutrition Facts label.
c. Dietary Cholesterol
    (Comment 93) In the proposed rule (87 FR 59168 at 59181), we 
tentatively concluded that it was unnecessary to include limits for 
dietary cholesterol as part of the updated ``healthy'' criteria 
because, similar to our approach with trans fat, dietary cholesterol 
would already be sufficiently limited by the proposed limits for 
saturated fat. We invited comment on our proposed approach, including 
any data showing that the saturated fat limit would not adequately 
limit dietary cholesterol or any data indicating that foods with both 
lower amounts of saturated fat and higher amounts of dietary 
cholesterol (i.e., seafood and eggs) should not be able to qualify for 
the ``healthy'' claim.
    Several comments agree that we should not include a limit for 
dietary cholesterol for the ``healthy'' claim, noting that limits on 
dietary cholesterol would be redundant given the limits for saturated 
fat, and that dietary cholesterol limits would also deter consumption 
of nutrient-dense foods, particularly eggs and other protein products. 
One comment explains that replacing saturated fat with unsaturated fat 
is more important for lowering LDL-cholesterol and that scientific 
evidence does not support limiting dietary cholesterol to lower LDL-
cholesterol. The comment agrees that the saturated fat limits would 
adequately address dietary cholesterol because dietary cholesterol and 
saturated fat are often found in the same foods, noting that the 
exceptions of eggs and shellfish are nutrient-dense foods that can be 
incorporated into a healthy dietary pattern.
    (Response 93) We agree that the saturated fat limits adequately 
address dietary cholesterol. As noted in the proposed rule (87 FR 59168 
at 59181), the Dietary Guidelines, 2020-2025 does not make any 
recommendations regarding intake of dietary cholesterol, but the 
National Academies recommend that dietary cholesterol consumption be as 
low as possible without compromising the nutritional adequacy of the 
diet. We also noted in the proposed rule that the 2020 DGAC Report 
stated that it is difficult to assess the independent effects of 
dietary cholesterol on blood lipids and CVD because dietary cholesterol 
is found in sources that are also typically sources of saturated fat. A 
dietary pattern that is low in saturated fat is typically low in 
dietary cholesterol. Thus, the saturated fat limits for the definition 
of the ``healthy'' claim will adequately address dietary cholesterol 
because of their common food sources.
    (Comment 94) Two comments support the inclusion of a dietary 
cholesterol limit, noting that studies show an adverse association with 
dietary cholesterol and blood cholesterol or cardiovascular health. One 
of these comments states that the proposed rule ignores the role of 
cholesterol on cardiovascular health by not including a dietary 
cholesterol limit. The comment also notes that an average-sized egg 
contains 186 milligrams of cholesterol and that some sub-groups of the 
population (i.e., those with high cholesterol, diabetes, or 
cardiovascular disease) are advised to limit their intake of 
cholesterol to less than 200 mg/day.
    (Response 94) As explained in the previous response and discussed 
in the 2020 DGAC Report, it is difficult to assess the independent 
effects of dietary cholesterol on blood lipids and CVD because dietary 
cholesterol is found in sources that are also typically sources of 
saturated fat (Ref. 8). In the proposed rule, we explained that we 
expect that the saturated fat limits would sufficiently limit most 
foods that contain more than 60 mg of cholesterol, with a few 
exceptions such as eggs and some shellfish (87 FR 59168 at 59181). In 
the Dietary Guidelines, 2020-2025, eggs and seafood (which includes 
fish and shellfish) are listed as examples of

[[Page 106121]]

nutrient-dense foods and are identified in the Key Recommendations as 
examples of one of the core elements--protein foods--in a healthy 
dietary pattern. While some sub-groups of the population who are 
considered at-risk for certain chronic diseases (e.g., those with high 
blood cholesterol) or who have certain chronic diseases (e.g., those 
with CVD) may aim to lower their intake of dietary cholesterol, the 
``healthy'' claim is intended to help the general population identify 
foods that are particularly useful in helping them build a healthy 
dietary pattern. Individuals with specific health conditions or 
concerns can use the Nutrition Facts label to identify foods that 
contain higher amounts of dietary cholesterol. For these reasons, and 
the reasons discussed in the previous response, we decline to change 
our approach for dietary cholesterol and a limit for dietary 
cholesterol is not included as part of the updated criteria.
    (Comment 95) One comment discusses the importance of consumer 
education and data monitoring related to dietary cholesterol. The 
comment explains the importance of providing information to help 
consumers interpret how to use the ``healthy'' claim, particularly in 
the context of amounts of foods consumed, so that foods such as eggs, 
as well as other foods labeled as ``healthy,'' are not overconsumed. 
The comment also recommends that FDA monitor the impact of the updated 
``healthy'' claim on dietary cholesterol intake.
    Other comments ask that we perform data monitoring to evaluate the 
impact of the updated ``healthy'' claim on the presence of different 
nutrients or ingredients in the marketplace or on the dietary intake of 
different nutrients or ingredients.
    (Response 95) We agree that excessive consumption of foods labeled 
as ``healthy'' is an important topic and that consumer education may 
help consumers use the ``healthy'' claim to help build healthy dietary 
patterns. We plan to undertake consumer education efforts, which could 
address, for example, the importance of both staying within calorie 
limits and choosing a variety of nutrient-dense foods within and across 
different food groups and subgroups--two concepts that are an integral 
part of the Dietary Guidelines, 2020-2025. We also plan to monitor and 
evaluate the impacts of the updated ``healthy'' definition after its 
implementation.
d. Other Comments on Nutrients Not Included
    (Comment 96) One comment recommends that we consider an absolute 
calorie limit--such as 200 calories, 400 calories, and 600 calories per 
labeled serving or RACC (whichever is larger) for individual foods, 
main dishes, and meals, respectively--as part of the ``healthy'' 
criteria to discourage the consumption and development of high calorie 
foods.
    (Response 96) We included FGE criteria and NTL criteria in the 
updated definition for the ``healthy'' nutrient content claim to help 
consumers identify foods that are particularly useful in building a 
healthy dietary pattern, which are nutrient-dense foods. Nutrient-dense 
foods are described in the Dietary Guidelines, 2020-2025, as providing 
vitamins, minerals, and other health-promoting components while having 
little or no added sugars, saturated fat, and sodium (Ref. 1). Because 
nutrient-dense foods contain little or no excess calories, and/or are 
prepared with little or no excess calories, from added sugars or 
saturated fat, they tend to have a higher amount of nutrients per 
calorie. While we did not include a specific calorie limit in the 
proposed criteria, calories are taken into consideration indirectly in 
the ``healthy'' definition by including criteria for NTL for saturated 
fat and added sugars (which provide calories) as well as FGE criteria. 
FGE criteria were determined based on a 2,000 calorie diet; therefore, 
the amount of nutrient-dense foods needed to meet the FGEs are based on 
recommended nutrient amounts within that calorie limit. The comment did 
not provide any data or information demonstrating why an absolute 
calorie limit would be necessary or that the FGE and NTL criteria were 
not sufficient in limiting calories, nor did it explain how calorie 
limits were calculated or determined. Therefore, we decline to include 
a limit for calories on top of the FGE and NTL criteria.
    (Comment 97) One comment requests that we exempt foods that qualify 
for the ``healthy'' claim from Sec.  101.13(h), which requires a 
disclosure statement for foods with certain levels of cholesterol. The 
comment says that, without an exemption, foods might give consumers 
mixed messages about dietary cholesterol.
    (Response 97) Disclosure statements are required when ``a food that 
bears a nutrient content claim contains a nutrient at a level which 
increases to persons in the general population the risk of a disease or 
health-related condition which is diet related'' (see section 
403(r)(2)(B) of the FD&C Act). The nutrients that require disclosure 
statements include total fat, saturated fat, cholesterol, and sodium 
(Sec.  101.13(h)). These nutrients are also included as NTL in the 
original definition of ``healthy'' (Sec.  101.65(d)). As discussed 
earlier in this section, total fat and dietary cholesterol are no 
longer included as NTL in the definition. The Dietary Guidelines, 2020-
2025, does not include a key recommendation for intake of total fat or 
dietary cholesterol (see Response 93) (Ref. 1). Thus, disclosure 
statements for total fat or cholesterol are not required for use of the 
claim ``healthy.'' The saturated fat limits we are finalizing will help 
ensure that foods with higher amounts of total fat that use a 
``healthy'' claim are predominantly comprised of unsaturated fats, and 
that cholesterol-containing foods are limited. There are situations 
where foods that qualify for the claim may contain saturated fat in 
amounts that exceed the disclosure level for saturated fat. The updated 
``healthy'' definition provides exclusions for inherent saturated fat 
contained in certain food groups and subgroups (e.g., nuts, seeds, and 
soy products and seafood) that have fat profiles that are predominantly 
made up of unsaturated fat. As discussed in the saturated fat section 
above, these exclusions are supported by current nutrition science and 
result in nutrient-dense foods that are encouraged by the Dietary 
Guidelines, 2020-2025 being able to qualify for the claim. Because 
these foods, which may contain saturated fat that exceeds the 
disclosure level, are nutrient-dense foods encouraged by the Dietary 
Guidelines, 2020-2025 and are foundational for healthy dietary 
patterns, we conclude that disclosure statements highlighting these 
levels of saturated fat are unnecessary and foods that bear the 
``healthy'' claim are exempt from the requirement for disclosure 
statements for saturated fat in Sec.  101.13(h).
    (Comment 98) Several comments discuss certain ingredients or 
chemicals, besides nutrients, that can be present in foods and whether 
they should be considered as part of the criteria for the ``healthy'' 
claim. Some comments argue that the proposed rule's focus on sodium, 
saturated fats, and added sugars leaves open the possibility for 
products to bear ``healthy'' labels despite containing ``unhealthy'' 
compounds not covered by the rule.
    (Response 98) As explained in the preamble to the proposed rule (87 
FR 59168 at 59169), since 1994, we have recognized that labeling that 
describes a

[[Page 106122]]

food product as ``healthy'' in a nutritional context is making an 
implicit claim of the level of nutrients of the product. The presence 
or absence of ingredients other than nutrients in a food product (e.g., 
preservatives, colorings, contaminants (including toxic elements), 
pesticides, oxalate) is outside of the scope of the ``healthy'' 
nutrient content claim. Similarly, information about the production 
method of a food (e.g., genetically engineered or organic) is beyond 
the scope of the ``healthy'' nutrient content claim as it does not 
characterize the level of nutrients in a food.
7. Nutrients To Encourage
    (Comment 99) Some comments support eliminating the NTE (i.e., 
nutrients that are underconsumed and whose low intake in the general 
population or in individual subpopulations raise public health concern) 
requirement. The comments assert that the NTE requirement has allowed 
food manufacturers to fortify non-nutrient-dense foods for the sole 
purpose of qualifying as ``healthy'' without improving the 
healthfulness of the products. The comments provide that the 
``healthy'' claim should not appear on heavily processed, non-nutrient-
dense foods that have been fortified to meet the claim's criteria. Many 
comments say the food group-based approach we proposed by FDA, noting 
that it is consistent with dietary recommendations for healthy dietary 
patterns and may minimize the unintended consequences of focusing 
solely on individual nutrients. Other comments support the shift away 
from the NTE requirement by noting that certain foods would not qualify 
as ``healthy'' if there were NTE requirements, despite evidence in 
support of the health benefits of these foods (e.g., mushrooms).
    Other comments oppose the exclusion of the NTE criteria from the 
rule. The comments assert that nutrients, such as vitamins, minerals, 
fiber, and protein, should continue to be part of the ``healthy'' 
nutrient claim criteria. One comment supports FDA's food group-based 
approach as an effective way to encourage consumers to eat a variety of 
foods as part of a balanced diet, but believes it is still important to 
retain some additional nutrient requirements for certain food 
categories to help ensure that these foods provide a similar nutrient 
profile to comparable foods, including for plant-based alternatives to 
dairy products.
    (Response 99) The Dietary Guidelines, 2020-2025 (Ref. 1) focuses on 
the importance of a healthy dietary pattern as a whole and its role in 
promoting health, reducing risk of chronic diseases, and meeting 
nutrient needs. The original definition for the ``healthy'' nutrient 
content claim was based solely on individual nutrients, including a 
minimum amount of a beneficial nutrient and specific allowable limits 
for other nutrients, and is inconsistent with current nutrition 
understanding of healthy dietary patterns and their effect on health 
and development of chronic disease. Foods that contain certain NTE, 
such as vitamins, minerals, or fiber, can be beneficial to consumers. 
However, requiring that foods contain a certain amount of individual 
NTE in order to qualify for the ``healthy'' claim would not necessarily 
help consumers identify foods that are particularly useful, based on 
their overall nutrient profile, for building healthy dietary patterns. 
Additionally, as we explained in the proposed rule, including criteria 
for NTE 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 (87 FR 59168 at 59176). Including requirements for specific 
amounts of foods from across all of the recommended food groups better 
reflects how nutrients work together and make up the food groups and 
subgroups that are part of a healthy dietary pattern. We conclude that 
the criteria of the ``healthy'' claim should include FGE requirements 
instead of requirements for individual NTE in the definition. 
Furthermore, we decline to revise the definition to include any 
requirements for NTE in addition to the FGE requirements, considering 
that consumption of the recommended amounts of food across all of the 
recommended food groups enables consumers to create healthy dietary 
patterns and achieve nutrient adequacy. For more on how we are ensuring 
that alternative dairy foods provide the same nutrient profile as 
traditional dairy in order to qualify in the dairy food group to bear 
the ``healthy'' claim, please see Response 32.
    (Comment 100) One comment suggests that, if FDA decides to keep the 
NTE requirement, we should require foods to meet the nutrition criteria 
without fortification. The comment suggests that FDA would also need to 
create exemptions for certain fruits, vegetables, and nuts that do not 
meet the NTE requirement.
    (Response 100) As discussed in the previous response, we decline to 
retain or add any requirements for NTE in place of or in addition to 
FGE requirements. Instead, the ``healthy'' definition includes criteria 
of FGEs for the food groups encouraged by the Dietary Guidelines, 2020-
2025. Therefore, considerations regarding fortification or exemptions 
based on NTE are not necessary.
    (Comment 101) Some comments assert that both inherent and fortified 
nutrients should be allowed. One comment provides that the body does 
not discern whether a nutrient comes from an intrinsic or fortified 
source and that nutrients from either an intrinsic or fortified source 
contribute equally toward the overall nutrient intake. The comments 
mention that the Dietary Guidelines recognize that, in some cases, 
fortified foods may be useful in providing one or more nutrients that 
otherwise may be consumed in less than recommended amounts. The 
comments contend that, because manufacturers are already subject to 
FDA's existing fortification policy, exclusion of the NTE criteria is 
unnecessary. A number of comments mention that the Dietary Guidelines 
make reference to the value of choosing fortified foods to help meet 
nutrient needs for certain vitamins and minerals. One comment cites as 
an example the Dietary Guidelines' reference to Vitamin D being harder 
to acquire through natural sources from the diet alone, thus requiring 
the consumption of foods and beverages fortified with Vitamin D in 
order to achieve nutrient adequacy. Another comment mentions that, 
given ``healthy'' is a nutrient content claim, the inclusion of 
positive nutrients and food groups is prudent.
    (Response 101) As previously stated, we decline to amend the 
definition to include any requirements for NTE in addition to the FGEs. 
FGE criteria based on the consumption of food across all of the 
recommended food groups will help consumers in identifying foods that 
are particularly useful in constructing healthy dietary patterns. 
Because requirements for NTE are not included in the definition, we do 
not need to address issues related to inherent or fortified nutrients. 
The presence of individual nutrients in a food, and knowledge about the 
benefits, however, may be useful to consumers, and, as previously 
discussed, manufacturers may communicate such information in many 
different ways. While highlighting foods with significant levels of a 
nutrient may be useful to some consumers, we reiterate that helping 
consumers identify nutrient-dense foods from the recommended food 
groups, which better reflects the overall nutrient content of foods, 
can better help consumers in creating healthy dietary patterns to 
maintain healthy dietary

[[Page 106123]]

practices, which is the primary purpose of the ``healthy'' claim.
    (Comment 102) Some comments recommend a first ingredient approach 
combined with a NTE requirement as an alternative option to the 
proposed FGE requirements, such that the FGE criteria would be 
considered to be met if a food's first ingredient (or for foods other 
than beverages, the second ingredient if the first ingredient is water 
or broth) is in one of the food groups to encourage and a NTE 
requirement is met. Other comments recommend that, as an alternative 
option to food group requirements, FDA allow a food to qualify for the 
``healthy'' claim if, in addition to meeting the NTL criteria for 
sodium, saturated fat, and added sugars, the food also meets NTE 
thresholds of nutrients such as dietary fiber, protein, vitamin D, 
calcium, potassium, or iron. The comments distill this recommendation 
as allowing foods to qualify for healthy if they meet both: (1) NTL 
criteria and (2) either the minimum amount for an inherent or fortified 
positive nutrient or the food group criteria. Another comment 
recommends an alternative approach of including a target of 10% DV for 
nutrients identified by the Dietary Guidelines as being at risk of 
underconsumption as a way to qualify for the ``healthy'' claim. Another 
comment recommends an approach involving a scaled percentage DV of NTE 
for different food groups, regardless of FGE content.
    (Response 102) We decline to adopt a first ingredient approach to 
determine FGEs because, as discussed in Response 11, it is not a 
reliable way to help consumers identify foods that can help them meet 
recommended food group amounts. As discussed in Response 99, we 
conclude that the criteria for the ``healthy'' claim should include FGE 
requirements instead of requirements for individual NTE in the 
definition because requiring foods to contain a certain amount of 
individual nutrients to qualify for the ``healthy'' claim would not 
necessarily help consumers identify foods that are particularly useful 
for building healthy dietary patterns. Furthermore, combining an NTE 
requirement with a ``first ingredient'' approach would not be more 
effective than an FGE requirement. Because a ``first ingredient'' 
approach would lead to uncertainty about the specific amount of a food 
group in a product, such an approach combined with the presence of a 
single NTE in the product would not help consumers identify foods that 
are particularly useful for building healthy dietary patterns.
    (Comment 103) The comments assert that, with the proposed 
limitations on saturated fat, sodium, and added sugars, the exclusion 
of NTE criteria would lead to underconsumption of nutrients that are 
necessary for healthy dietary patterns. The comments recommend that FDA 
include NTE criteria for nutrients identified as dietary components of 
public health concern by the Dietary Guidelines, including calcium, 
dietary fiber, potassium, and vitamin D. One comment contends that the 
proposed rule would exclude many foods that are nutrient-dense, for 
example, foods containing meaningful amounts of NTE, based solely on 
their nominal added sugars content; foods having slightly less than the 
precise amounts of food groups required by the proposal; or foods 
containing slightly more sodium than the proposal would require.
    (Response 103) We disagree that excluding NTE criteria would lead 
to underconsumption of nutrients of public health concern. As discussed 
above, and per the Dietary Guidelines, 2020-2025, if a healthy dietary 
pattern is consumed, i.e., a diet that meets the recommended daily 
amount of food from across the recommended food groups, the intake of 
nutrients of public health concern such as calcium, dietary fiber, 
potassium can meet the daily requirements (Ref. 1). The requirements 
for vitamin D can be met as well, except in specific cases, such as 
situations where climate and sunlight exposure become an issue. A 
``healthy'' claim can help consumers identify the foods that are 
particularly useful in constructing healthy dietary patterns and thus 
meeting nutrient requirements, including nutrients of public health 
concern. It is for this reason that the ``healthy'' claim definition 
includes requirements for FGEs. We recognize, though, that, for some 
specific individuals and situations, nutrients in dietary supplements 
and/or fortified foods could be useful, and those benefits can continue 
to be communicated to consumers through various truthful and non-
misleading label statements.
    (Comment 104) One comment notes the health benefits of antioxidants 
and omega fatty acids and recommends that FDA devise a system that 
reflects the relationship of a specific foods' overall essential 
nutrient content in relation to the caloric space that the food takes 
up in a person's daily diet.
    (Response 104) As discussed previously, the original definition for 
``healthy'' reflected an individual nutrient-centric approach, but 
nutrition science and dietary recommendations have evolved since the 
time the original definition was developed. The construction of overall 
healthy dietary patterns, and not the identification of foods with 
specific individual nutrient amounts, is most associated with promoting 
health and reducing chronic disease risk in the general public (Ref. 
1). For the reasons previously discussed, we conclude that the criteria 
of the ``healthy'' claim should include FGE requirements, along with 
nutrient limits, instead of requirements for individual NTE in the 
definition. FGE requirements better reflect the overall nutrient 
content of a food and the array of nutrients that are contained in the 
different food groups, including examples mentioned in the comment. 
Further, we made other adjustments to the criteria to support the use 
of the ``healthy'' claim on certain nutrient-dense foods from the 
recommended food groups. For example, we have made adjustments to 
exclude the inherent saturated fat in nuts, seeds, and soy products, 
and seafood from the saturated fat criteria, because their fat profile 
is predominantly unsaturated fat (e.g., omega-3 and omega-6 fatty 
acids), and an adjustment so that nutrient-dense single-ingredient 
foods encouraged by the Dietary Guidelines can automatically qualify 
for the claim. The presence and benefits of individual nutrients can 
still be communicated in many different ways and through many different 
types of truthful and non-misleading statements on the label.

E. Combination Foods (i.e., Mixed Products, Main Dish Products, and 
Meal Products)

1. General Comments
    (Comment 105) Many comments object to FDA's proposed requirement 
that at least one FGE from one, two, or three different food groups 
must be present in every individual product/mixed product, main dish, 
or meal, respectively. The comments note that the proposed framework is 
not reflective of the practical realities of recipe design and that 
recipes do not always contain a full FGE from one, two, or three food 
groups. They request that FDA instead allow for aggregation of any 
volume or fractions of defined food groups to contribute to the total 
FGE requirements for mixed products, main dishes, and meals. The 
comments mention that permitting aggregation of any volume or fractions 
of defined food groups in meeting FGEs in combination foods will allow 
for more flexibility in recipes while still promoting intake of 
underconsumed food groups.
    One comment mentions that pasta products can be made with a variety 
of nutrient-dense ingredients, such as

[[Page 106124]]

vegetables and legumes, and that, under the proposed requirements, such 
pasta products would require either one full FGE of grains or 
vegetables, or \1/2\ FGE of grains and \1/2\ FGE of vegetables. The 
comment requests that FDA revise the FGE requirements so that an 
individual food or mixed product would qualify if it contains a total 
of 1 FGE from one or more different food groups, so that, for example, 
products containing \1/3\ FGE vegetable and \2/3\ grain, or \1/4\ FGE 
vegetable and \3/4\ FGE grain could qualify. According to the comment, 
this would better reflect the overall food group contribution of, for 
example, a pasta product that contains a meaningful contribution to 
both the whole grains and vegetable food groups.
    (Response 105) As described in the proposed rule, combination foods 
are foods that contain a meaningful amount of more than one food group. 
The proposed rule required that a mixed product needed to contain at 
least \1/2\ FGE each of two different foods groups per RACC to meet the 
FGE criteria (87 FR 59168 at 59190). The requirement that mixed 
products contain \1/2\ FGE from two different food groups effectively 
provides one total FGE, similar to individual foods, since mixed 
products are similar in size to an individual food. As the comments 
note, however, the components of mixed products are not always divided 
into exactly \1/2\ FGE of different food groups. For example, a mixed 
food may have \2/3\ FGE of one food group and \1/3\ FGE of a different 
food group. Although the proportions would not be exactly \1/2\ FGE for 
each food group, the total amount of FGE would still be one FGE. We 
recognize that requiring at least \1/2\ FGE from two different food 
groups could restrict formulations of foods that could otherwise 
contribute meaningful FGE amounts to the diet and manufacturers could 
potentially be limited in the types of healthful food offerings they 
could provide to consumers. For this reason, we have revised the 
criteria for mixed products at Sec.  101.65(d)(iv). The final rule 
allows for two or more food groups to contribute to the 1 FGE total for 
mixed products; the food groups contributing to the 1 FGE (``qualifying 
food groups'') must be present in amounts of at least \1/4\ FGE. We are 
setting this threshold because setting the level lower than \1/4\ FGE 
would not provide meaningful amounts of the required food groups in 
mixed products and therefore not be as effective in helping consumers 
meet the daily recommended amounts for the food groups. Similarly, for 
main dish products and meal products, we conclude that flexibility 
should be provided by allowing varying proportions of the FGE amounts 
required for the food. We acknowledge that main dish products might not 
contain at least 1 FGE each of two different food groups and that meal 
products might not contain at least 1 FGE each of three different food 
groups. Rather, the foods may have less of one food group and more of 
another and still be nutrient-dense. With these changes, the total 
amount of FGE required for main dish products and meal products would 
still be the same as proposed, but the required minimum contributions 
of each of the individual components FGEs is reduced. Although a 
minimum of one full FGE from each qualifying food group component will 
not be required, the rule will require the product to have no less than 
\1/2\ FGE from each of the two qualifying food group components for 
main dishes, or each of three qualifying food group components for 
meals, so that the product provides a meaningful amount of the 
respective food groups (see Sec.  101.65(d)(iv) and (v)). For example, 
a main dish could contain \1/2\ FGE of vegetables and 1 \1/2\ FGE of 
whole grains, totaling two full FGEs. As another example, a meal 
product could contain \1/2\ FGE of dairy, \3/4\ FGE of protein foods, 
and 1 \3/4\ FGE of whole grains, combining for 3 full FGEs.
    Pasta products, which are most commonly made of wheat, would 
typically fall under the individual foods criteria for grain products. 
The comments, however, discuss pasta products that might be made from 
both grain ingredients and vegetable ingredients. With the updated FGE 
criteria for mixed products, these type of pasta products could qualify 
for use of the ``healthy'' claim as a mixed product if the product 
contained a total of one full FGE from whole grain and vegetable 
ingredients, with a minimum FGE amount for the qualifying food groups 
of \1/4\ FGE. For example, the whole grain ingredients could contribute 
\3/4\ of the whole grain FGE and the vegetable ingredients could 
contribute \1/4\ of the vegetable FGE. The adjustments in the required 
minimum FGE amounts provides flexibility in the qualification of 
combination foods while also providing consumers with meaningful 
amounts of food groups recommended for building healthy dietary 
patterns.
    (Comment 106) In the proposed rule, we proposed specific NTL 
criteria for combination foods, and many comments address these 
proposed limits for sodium, added sugars, and saturated fat.
    Some comments express that the proposed criteria for combination 
foods are difficult to follow. Some comments request that FDA provide 
more examples of these types of products to help with understanding the 
final criteria.
    Some comments note that, while they agree that nutritious dietary 
patterns should contain less sodium and added sugars and more whole 
foods, the rule for combination foods products places limits on added 
sugars, sodium, and saturated fat, without providing a scientific 
rationale regarding why some products have different limits than others 
(i.e., depending on the food groups contained in the product). The 
comments request more information about the rationale for the 
distinction and request that FDA standardize the requirements for added 
sugars, sodium, and saturated fat among combination foods that contain 
different food groups.
    One comment suggests an alternative framework and several comments 
refer to and express support for this alternative framework. The 
alternative framework would combine FDA's proposed individual foods and 
mixed products food categories into one category, and further delineate 
the combined individual/mixed food category by RACC size to include a 
small RACC subcategory, as defined in Sec.  101.13, as individual foods 
with RACCs that are 30 g or less or 2 Tbsp or less. The alternative 
framework would retain the original food categories of main dishes and 
meals. The comment requests that the limits for sodium, added sugars, 
and saturated fat increase in a stepwise manner based on RACC/serving 
size that correlate to specific food categories and do not vary based 
on food groups. The comment suggests the following limits for sodium:
     10% DV sodium per RACC for the individual and mixed food 
category with small RACCs;
     20% DV sodium per RACC for individual and mixed foods with 
a RACC >30g;
     25% DV sodium per serving for main dishes; and
     30% DV sodium per serving for meals.
    With respect to added sugars, the comment questions why there is 
not a sliding scale for added sugars limits based on the proportional 
RACC/serving size. The comment recommends the same percentage limits 
for added sugars as it does for sodium limits. The comment also 
suggests a stepwise increase in saturated fat limits, as follows:
     5% DV saturated fat per RACC for the individual and mixed 
food category with small RACCs;

[[Page 106125]]

     10% DV saturated fat per RACC for individual and mixed 
foods with a RACC >30g;
     15% DV saturated fat per serving for main dishes; and
     20% DV saturated fat per serving for meals.
    (Response 106) We calculated the proposed NTL criteria for 
combination foods based on the criteria for the individual component 
food groups. For mixed products, we calculated the limits by finding 
the average of the NTL criteria for their component food groups (87 FR 
59168 at 59191). For main dishes and meal products, we calculated the 
NTL criteria by adding together the nutrient limits for the two or 
three individual food groups, respectively, that make up the food 
product (id. at 59192 to 59193). For example, for a whole grain 
vegetable lasagna main dish, the sodium limit as proposed would be 
<=20% DV (<=10% DV for whole grains plus <=10% DV for vegetables). We 
explained in the proposed rule that, because there is variation in the 
saturated fat limits for different subgroups of protein foods, the 
proposed saturated limit for combination products containing protein 
varied depending on the type of protein in the product. Similarly, 
because there was variation in the proposed added sugars limits for 
different food groups, the proposed added sugars limits for combination 
products also varied depending on the food groups (or subgroups) in the 
product.
    Due to the different proposed limits for the individual food groups 
and subgroups, however, the resulting criteria for all of the 
possibilities of combination foods were numerous and complicated. 
Additionally, as some comments explain, combination foods are not 
typically formulated by only adding the foods from two or three 
different food groups together, but, rather, are formulated to include 
foods from the different food groups along with other ingredients 
(e.g., sauces and seasonings). To simplify and streamline the criteria 
and also to provide some flexibility in formulations and recipes for 
combination foods, the final rule, at Sec.  101.65(d)(3)(iii) through 
(v), revises the NTL criteria for combination foods.
    Sodium. We agree with comments that support an incremental or 
stepwise approach for the NTL across food categories. In the proposed 
rule, the sodium limits for most individual foods and for mixed 
products, which typically have RACCs similar in size to individual 
foods, were set at the baseline limit of <=10% of the DV (currently 
<=230 mg for adults and children 4 years of age and older) per RACC (87 
FR at 59192). In determining the baseline sodium limit, we considered 
many factors, such as the effects of sodium on health and chronic 
disease as well as the many functions of sodium in food, including 
taste, texture, microbial safety, and stability (see section V.D.3 for 
further discussion of sodium limits for individual foods). As mentioned 
previously, some comments provide information that explain that 
combination foods, such as mixed products, are not necessarily 
formulated by just adding foods from two different food groups 
together, such as a vegetable and a grain product. Rather, recipes and 
formulations can include foods from different food groups along with 
other ingredients to create particular taste profiles, flavors, etc. 
Additional components to the recipes could include ingredients such as 
seasonings and sauces and some additional sodium is often present in 
the formulations of mixed products in the additional ingredients, such 
as a sauce or seasonings. For this reason, we determine that it is 
reasonable for mixed products to have a sodium limit that is 
incrementally higher (<=15% DV per RACC) than the sodium limit for 
individual foods. Providing additional flexibility to the sodium limit 
for mixed products could also allow manufacturers to provide a greater 
variety of healthful options to consumers. However, considering the 
health effects of sodium consumption and the recommended total sodium 
limits in the diet, we conclude that mixed products should not exceed 
15% of the DV for sodium (currently <=345 mg for adults and children 4 
years of age and older) per RACC (or per 50 g for RACCs <=50 g or <=3 
Tbsp). The <=15% DV mixed product sodium limit at Sec.  
101.65(d)(3)(iv) increases the mixed product sodium limit from what we 
proposed by 50% without bringing the limit up to those of larger 
combination foods (i.e., main dish products and meal products).
    For main dish and meal products, we proposed sodium limits of <=20% 
and <=30% of the DV per labeled serving, respectively (87 FR at 59192 
and 59193), and we are finalizing these limits at Sec.  101.65(d)(3)(v) 
and (vi). These limits reflect the stepwise increase in size and number 
of food group components of these larger food products. At <=30% of the 
DV per labeled serving, a meal product, which contains FGEs from at 
least three different food groups, will have three times the allowable 
sodium limit of an individual food. As previously discussed, main dish 
products are required to contain FGEs from two different food groups. 
To scale the sodium limit proportionate to the FGE requirements, the 
sodium limit is set at <=20% of the DV per labeled serving for main 
dish products. This limit is twice the amount of the limit for an 
individual food. It is also \2/3\ the value of the meal products limit, 
which is appropriate due to the number of food group components 
required of main dishes compared to meal products. We conclude that the 
range of values from <=10% to <=30% of the DV for sodium, across the 
categories of foods (i.e., individual foods, mixed products, main 
dishes, and meals), appropriately reflects the increasing sizes and 
number of food group components in each food category, while still 
helping consumers identify foods across different food categories that 
can serve as a foundation for healthy dietary patterns and help stay 
below the daily recommended limit for sodium. Increasing the limits 
beyond those finalized in this rule, for example limits higher than 
<=10% for individual foods, <=15% for mixed products, and <=20% for 
main dishes, as requested in some comments, would not help consumers in 
identifying foods that can help them build healthy dietary patterns by 
staying below the daily recommended limit for sodium.
    Added Sugars. We are revising the limits for added sugars in the 
rule to be <=10% of the DV per RACC (or per 50 g for RACCs <=50 g) for 
all mixed products, regardless of their food group components (see 
Sec.  101.65(d)(3)(iii)). Setting the limit at <=10% DV simplifies and 
provides one standard value for all mixed products. Similar to the 
limits for sodium for combination foods, we agree that added sugars 
limits should incrementally increase across the different types of 
combination food products. Further, based on the comments that we 
received to the proposed rule and supported by our review of products 
available in the marketplace (Ref. 2), we find that it is reasonable to 
accommodate added sugars content that is higher than the range that we 
had proposed for mixed products, main dishes, and meals. Even though 
certain individual food group components may not contain many added 
sugars, some additional added sugars may be included in developing 
recipes and formulations for combination foods. While the proposed 
sodium limits for main dish and meal products were a single value for 
their individual categories (<=20% and <=30% of the DV per RACC), the 
proposed limits for added sugars for these categories varied depending 
on the

[[Page 106126]]

specific food groups that contributed to the FGEs. (See 87 FR 59168 at 
59192 to 59193.) For both main dishes and meal products, the added 
sugars limits ranged from 0% of the DV to <=10% of the DV depending on 
the food group components (id.). To simplify the requirements, we 
revised the rule to provide a single added sugars limit value for each 
combination food category that incrementally increases across the 
combination food categories in a way that reflects their sizes and 
number of food group components (see Sec.  101.65(d)(3)(iii)-(v)). 
Additionally, the rule increases the added sugars limits above the 
highest proposed levels for each of the combination food categories, 
which may allow for flexibility in formulations and recipes for 
combination foods.
    For main dish products, we are setting the added sugars limit 
incrementally higher than mixed products at <=15% of the DV per labeled 
serving (see Sec.  101.65(d)(3)(v)). The rule's limit of <=15% DV added 
sugars for main dish products is an increase from the highest proposed 
added sugars limit for mixed products of <=10% of the DV, which may 
provide for flexibility in formulations and recipes of healthy main 
dish options that manufacturers can provide to consumers while still 
helping consumers to identify foods that help them stay within the 
daily recommended intake limit for added sugars. Likewise, the rule 
increases the proposed limit for added sugars for meal products to 
<=20% of the DV per labeled serving (see Sec.  101.65(d)(3)(v)). Meal 
products must have one more food group component than main dishes and 
are larger products that constitute the entirety of a meal. Thus, the 
increase to <=20% of the DV represents an incremental increase of added 
sugars from the <=15% of the DV limit for main dish products. As with 
the other combination foods, increasing the added sugars limit for 
meals may result in manufacturers' being able to provide a wider 
variety of healthy food product options to consumers while still 
helping consumers identify foods that can help them build healthy 
dietary patterns by staying within daily recommended intake limits.
    Saturated Fat. The final rule also streamlines and simplifies the 
criteria for saturated fat. Similar to the proposed limits for added 
sugars, the proposed limits for saturated fat for combination foods 
varied depending on the specific food groups that contributed to the 
FGEs (see 87 FR at 59192 to 59193). For combination foods, the proposed 
saturated fat limits ranged from <=5% of the DV to <=25% of the DV, 
depending on the food group components (id.). As with the other 
nutrient criteria, the different possibilities for saturated fat limits 
of combination foods were numerous and resulted in complicated 
calculations. Therefore, to simplify the requirements, the final rule 
sets a single saturated fat limit value for each combination food 
category (mixed products, main dish products, meal products) (see Sec.  
101.65(d)(3)(iii)-(v)). Similar to the limits for sodium and added 
sugars, the limits for saturated fat for combination foods increases 
incrementally across combination food categories. For mixed products, 
we are setting one limit for saturated fat of <=10% of the DV per RACC 
or per 50 g for RACCs <=50 g (see Sec.  101.65(d)(3)(iii)). In 
determining the saturated fat limit for mixed products, we found that 
some considerations were different than those for added sugars and 
sodium. For example, there are already modifications to the saturated 
fat criteria to allow flexibility for inherent saturated fat for some 
food groups (i.e., where the fat composition is made up of 
predominantly unsaturated fat). In addition, there are options to use 
other types of fat, specifically unsaturated fats, to replace saturated 
fat in foods (e.g., using vegetable oils higher in unsaturated fat 
instead of palm oil or butter). Therefore, unlike for added sugars and 
sodium, we did not make additional adjustments for mixed products above 
the highest saturated fat limit for individual foods and the rule sets 
the limit for saturated fat at <=10% of the DV per RACC or per 50 g for 
RACCs <=50 g (see Sec.  101.65(d)(3)(iii)). As described for 
determination of the added sugars and sodium limits, the nutrient 
limits across combination foods should appropriately reflect the 
increasing sizes and number of food group components in each food 
category. Thus, for main dish products which consist of two full FGEs, 
we are setting the saturated fat limit at <=15% of the DV per labeled 
serving (see Sec.  101.65(d)(3)(iv)). For meal products, we are setting 
the limit at <=20% of the DV per labeled serving (see Sec.  
101.65(d)(3)(v)). As with the other criteria, the saturated fat limits 
increase across the food categories. The limits range from <=5% DV for 
some individual foods to <=20% DV for meal products. The saturated fat 
limits for the original ``healthy'' definition aligned with the ``low 
saturated fat'' nutrient content claim. Depending on the weight of the 
main dish or meal product, the saturated fat limits in the final rule 
are the same or higher than the original limits. Increasing the 
saturated fat limits, compared to the original definition, results in 
different nutrient-dense foods being able to contribute towards FGEs 
for combination foods. For example, certain nutrient-dense foods that 
contain higher amounts of saturated fat, such as low-fat dairy or eggs, 
are recommended by the Dietary Guidelines as core elements of healthy 
dietary patterns. Combination foods that have these nutrient-dense 
foods as contributors to the FGE requirements are useful in building 
healthy dietary patterns and the saturated fat limits reflect this. The 
streamlined and simplified criteria for combination foods are provided 
in the table below.
[GRAPHIC] [TIFF OMITTED] TR27DE24.007


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    (Comment 107) One comment claims that FDA provided very few 
examples of food products that would or would not meet the ``healthy'' 
criteria. The comment asserts that the lack of examples makes it 
difficult to evaluate the proposed definition, especially for 
combination foods. The comment mentions it is difficult to determine if 
a combination product on the market meets the minimum FGE requirements 
without access to the product's recipe. The comment urges FDA to 
conduct testing of the proposed definition with a variety of 
combination products to gain a better understanding of what products 
would or would not qualify, provide additional examples to the public, 
and determine what modifications to the proposed criteria are needed.
    (Response 107) The NTL calculations for combination foods are based 
on the FGE and NTL criteria for various individual foods and the level 
of nutrients present in a particular food is readily available from the 
Nutrition Facts label. We used our marketplace review to compare 
products available in the current marketplace against the limits for 
saturated fat, sodium, and added sugars for combination foods. For 
example, we reviewed the increases to the proposed added sugars limits 
for mixed products, main dishes, and meals, and the increase to the 
proposed sodium limit for mixed products that are discussed in Response 
106. Our marketplace review indicates that these increased limits 
provide more flexibility for nutrient-dense combination foods to be 
able to meet the NTL requirements, for example, certain bagged salads 
with dressing, plant-based patties, frozen grain and vegetable bowls, 
and frozen meals with sauces and seasonings, depending on their 
formulations (Ref. 2). Whether a particular combination food product 
will qualify for the ``healthy'' claim depends on the ingredients and 
recipe for the particular product (e.g., for determining which category 
a product would fall under--an individual food, mixed product, main 
dish, or meal--and therefore which nutrient to limit and FGE 
requirements apply); thus, it is difficult for FDA to provide extensive 
examples of combination food products that would qualify. However, 
manufacturers, who have access to all information necessary to 
determine a products eligibility, will be able to determine if their 
own foods, formulations, and recipes meet the requirements of the 
``healthy'' definition to label their foods appropriately.
    (Comment 108) One comment disagrees with FDA's proposal to count 
multiple equivalents of beans, peas, and lentils as either a protein 
food or a vegetable for combination foods, but not both, unless 
multiple types of food (e.g., both split peas and black beans) are 
present.
    The comment asserts that an FGE in excess of one does not lose 
nutritional value simply because only one member of the subgroup is 
present. The comment says such a restriction may lead to decreased 
product innovation on the part of manufacturers, who may choose to 
avoid using any volumes of such foods in excess of one equivalent if 
such volumes do not provide a potential labeling advantage via the 
``healthy'' claim.
    (Response 108) Under FDA's proposed framework, 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 could meet the vegetable group requirement while 
another food from the same subgroup could be used to meet the protein 
food requirement. If, however, the food product consists of only one 
type of food from the beans, peas, and lentils subgroup, the one type 
could not count toward both the vegetable and protein food group 
requirements in the same combination food. (See 87 FR 59168 at 59191).
    Although we proposed that beans, peas, and lentils may individually 
count as either a vegetable or a protein food in a combination food for 
purposes of FGE criteria, this requirement does not prevent 
combinations of bean, peas, and lentils from qualifying for the claim. 
There are many scenarios where these combinations can meet the 
``healthy'' requirements. For example, a food that has beans and peas 
(or any combination of beans, peas, and lentils) could qualify as mixed 
products or main dishes depending on the amount of FGEs contained. A 
mixed product food would need the amount of beans and peas to total one 
full FGE (e.g., \1/2\ FGE beans plus \1/2\ FGE peas). A main dish food 
would need the amount of beans and peas to total two full FGEs (e.g., 1 
FGE beans plus 1 FGE peas). Foods that are solely a mixture of these 
protein foods without other ingredients would also be able to qualify 
for the claim under the single-ingredient exemption. For example, a dry 
mix of black beans and peas could qualify under the single-ingredient 
exemption because both dry black beans and dry peas are single-
ingredient protein foods. Similarly, mixtures of solely one of the 
subgroup foods could fall under the single-ingredient exemption, such 
as a mixture of a dry black beans and dry red beans, which are both in 
the beans subgroup and single-ingredient protein foods. Foods that have 
just a single type of subgroup foods, such as only black beans, in 
excess of one FGE, could also qualify for the claim. The food could be 
considered as an individual food, a black bean food, and could fall 
under the requirements for individual protein foods. Having a food 
group ingredient in excess of the FGE does not automatically place the 
food into a combination food category. The criteria for ``healthy,'' 
including the single-ingredient-exemption, provides many different 
opportunities for beans, peas, and lentils, both in combination with 
each other or individually, to qualify for the claim.
2. Mixed Product (Sec.  101.65 (d)(3)(iii))
    (Comment 109) One comment requests additional clarification 
regarding the criteria for mixed products. The comment questions 
whether products that contain sufficient amounts from two different 
protein food subgroups, for example, a product that contains \1/2\ FGE 
of both seafood and nuts, would be eligible to bear the ``healthy'' 
claim.
    (Response 109) Consideration under the criteria for combination 
foods, including mixed products, requires that the food contain 
components of more than one food group, such as protein foods and whole 
grains (see Sec.  101.65(d)(3)(iv)-(vi)). Foods that contain multiple 
food components from the same food group, such as a food containing a 
mixture of fruit or a food that contains seafood and nuts, could 
qualify for the claim, but would be considered individual foods, rather 
than combination foods. As discussed in a previous response, the 
components of a mixed product can occur in varying proportions provided 
that the total FGE effectively is still one FGE and the FGE amount from 
each food group is not less than \1/4\ FGE.
    (Comment 110) One comment expresses concern that blended 100% juice 
products would be unfairly penalized under the proposed rule. The 
comment notes that, to qualify under the proposed rule, a 100% juice 
would either need to have \1/2\ cup fruit and \1/2\ cup vegetables, or 
\1/4\ cup fruit and \1/4\ cup vegetables. The comment notes that, under 
this proposed framework, a blended 100% juice product with \1/3\ cup 
fruit and \1/6\ cup vegetables would have \1/2\ cup total fruit and 
vegetables but would not have \1/4\ cup each of fruit and vegetables 
and would thus be ineligible to bear the ``healthy'' claim. The comment 
asserts that 100% blended

[[Page 106128]]

juices should qualify as ``healthy'' if they contain at least \1/2\ c-
eq of 100% juice, regardless of the proportion of fruit juice and 
vegetable juice. The comment also notes that, in a combination food 
containing fruit equivalents and protein equivalents, it will be 
challenging to meet the combination food requirements for FGEs. The 
comment provides that generally, 100% juice blends with protein contain 
protein isolates rather than whole protein sources. The comment urges 
FDA to allow combination foods to contain one FGE rather than both or 
allow protein isolates to be included in the protein subgroup.
    (Response 110) As proposed, blends of juices containing both fruit 
juices and vegetable juices that did not contain at least \1/2\ FGE of 
each would not have been able to qualify for the ``healthy'' claim. 
However, as discussed in Response 9, the final rule expands the 
proposed exemption for raw, whole fruits and vegetables to individual 
foods or mixed products that are comprised of one or more nutrient-
dense foods encouraged by the Dietary Guidelines, 2020-2025 (with no 
other added ingredients except for water). Therefore, a juice that is a 
blend of 100% fruit juice (a single-ingredient fruit product) and 100% 
vegetable juice (a single-ingredient vegetable product) now qualifies 
for the ``healthy'' claim without needing to meet the FGE criteria or 
NTL criteria (see Sec.  101.65(d)(3)(i)). In addition, as described in 
Response 106, the rule provides additional flexibility for mixed 
products by allowing varying proportions of the qualifying food groups 
provided that the total FGE is still one FGE and the FGE amounts from 
each of the qualifying food groups is not less than \1/4\ FGE (i.e., 
minimum of \1/8\ c-eq each of fruit or vegetable) (see Sec.  
101.65(d)(3)(iii)). Therefore, a blended 100% juice product with \1/3\ 
cup-eq fruit and \1/6\ cup-eq vegetables (that meets the NTL criteria) 
would now qualify for the ``healthy'' claim.
    Likewise, a juice blend of 100% juice and a single-ingredient food 
from other food groups, such as a single-ingredient protein food, would 
also be included in the exemption for single-ingredient foods and 
mixtures of single-ingredient foods. The juice blend could not have any 
other ingredients except water to qualify for the exemption. If other 
ingredients were included in the product, then the product would need 
to meet all requirements for a standard mixed product, specifically the 
FGE requirements and the NTL criteria. As discussed in the earlier 
section on protein foods, however, ingredients such as soy protein 
concentrates and soy protein isolates would not count toward meeting 
protein FGEs and would also not be considered a single-ingredient 
protein food (see Response 36). Therefore, a juice blend with 100% 
juice and soy protein isolates would not be eligible for the single-
ingredient exemption for ``healthy'' but could still qualify for use of 
the claim as an individual food if the applicable criteria were met.
3. Main Dish (Sec.  101.65 (d)(3)(iv))
    (Comment 111) One comment asserts that the proposed FGE 
requirements are misaligned with the regulatory definitions for main 
dishes and meals and are not consistent with the Dietary Guidelines. 
The comment provides that main dishes are defined, in part, as two 40 g 
food portions from at least two food groups and meals are defined, in 
part, as three 40 g food portions from at least 2 food groups. The 
comment notes that a meal, pursuant to FDA's regulatory definition of 
``meal,'' could be comprised of 80 g of vegetables and 40 g of protein 
and, even though nutrient-dense, would not qualify for the healthy 
claim as proposed because it is not comprised of 3 full FGEs from three 
different food groups. The comment asserts that FDA should allow for 
the calculation of composite FGEs that take into account meaningful 
contributions to multiple food groups.
    (Response 111) For the purposes of making a nutrient content claim, 
a main dish product contains not less than two 40 g portions of foods 
from at least two food groups and a meal product contains not less than 
three 40 g portions of foods from two or more food groups (Sec.  
101.13(l)-(m)). The final rule requires that a main dish product 
contain a total of two FGEs from two food groups and meal products 
contain a total of three FGEs from three food groups (see Sec.  
101.65(d)(3)(iv)). The requirements for the ``healthy'' claim do not 
conflict with the definitions of main dish and meal products in Sec.  
101.13, they are more limited, consistent with the purpose of the 
claim. While not all main dish and meal products will meet the criteria 
for the ``healthy'' claim, those that contain the required minimum FGE 
amounts and qualify for use of the claim will be products which are 
particularly useful in meeting the recommended food group amounts and, 
therefore, in building a healthy dietary pattern. See Response 105 and 
Sec.  101.65(d)(3)(iv) and (v) for the additional flexibility we are 
providing in the proportions of individual FGEs required for main 
dishes and meal products.
    (Comment 112) A comment asks that FDA establish saturated fat 
limits based on food categories that reflect the serving size of the 
food, rather than being dependent upon which food groups are present in 
the product. The comment notes that, for plant-based products, the 
proposed saturated fat levels would disqualify soy-based products, such 
as plant-based burgers, due to the levels established for saturated 
fat. The comment asserts that higher limits for saturated fat are 
warranted to account for their role on the plate.
    (Response 112) The final rule streamlines the criteria for 
saturated fat in combination foods, so that the limits are not 
dependent upon which food groups are present in the product. Whereas 
under the proposed rule, the saturated fat limits varied depending on 
the food group components, the final rule modifies the saturated fat 
limits for combination foods to a consistent amount, regardless of the 
food groups or subgroups contained in the mixed product, main dish, or 
meal (see Sec.  101.65(d)(3)(iv)-(vi)). Additionally, the saturated fat 
inherent in soybeans does not contribute to the saturated fat limit 
(see Sec.  101.65(d)(3)(ii)). These changes provide more flexibility 
(e.g., higher saturated fat limits), compared to the proposed rule, for 
soy-based products such as plant-based patties. (See Response 59.)
4. Meal Product (Sec.  101.65 (d)(3)(v))
    (Comment 113) One comment opposes the proposed increase in the 
sodium limit for meal products. The comment notes that, under current 
FDA regulations, a meal product or main dish making a ``healthy'' claim 
must contain no more than 26% of the DV for sodium per labeled serving, 
but, under the proposed criteria, a meal product would be allowed to 
contain 30% of the DV for sodium per labeled serving. The comment 
asserts that FDA should not increase the limit for sodium, as meals 
lower in sodium are healthier for consumers and more consistent with 
FDA's 2016 draft long-term Voluntary Sodium Reduction Goals.
    (Response 113) One of the objectives for updating the ``healthy'' 
definition is to ensure that the foods that are able to bear the 
``healthy'' claim are those that are recommended by dietary guidance, 
such as the Dietary Guidelines, as being particularly useful in 
building healthy dietary patterns. Therefore, individual foods such as 
grains, dairy, and vegetables that meet the individual sodium limit of 
<=10% of the DV per RACC are able to qualify for the claim. It follows 
that combinations of those

[[Page 106129]]

individual foods that qualify for the claim should be able to be 
eligible to bear the ``healthy'' claim as well. Setting the sodium 
limits at <=20% DV and <=30% DV per labeled serving, respectively, 
allows two full FGEs of individual foods that qualify for ``healthy'' 
to be combined into one ``healthy'' main dish product and three full 
FGEs of individual foods that qualify for ``healthy'' to be combined 
into one ``healthy'' meal product. Setting the limits at lower amounts 
would prevent some products that are combinations of ``healthy'' 
individual foods from using the ``healthy'' claim, thus preventing 
consumers from identifying combination foods that are consistent with 
the recommendations in the Dietary Guidelines and healthy eating 
patterns. The limits we are setting for sodium for the ``healthy'' 
claim, however, are upper limits, and combination foods are not 
required to contain sodium at that amount. The sodium limits for main 
dish products and meal products in the rule are <=20% and <=30% of the 
DV per labeled serving, respectively (Sec.  101.65(d)(3)(iv) and (v)).
    (Comment 114) A number of comments request that meal replacement 
shakes be allowed a higher added sugar limit. One comment notes that 
meal replacement products are intended to replace one or more 
conventional meals per day for weight management. The comment 
recommends that the rule contain a higher limit for added sugars of up 
to 30% DV in meal replacement products. The comment asserts that the 
change would increase palatability and could reduce the overall daily 
sugar intake for consumers compared to the current average.
    (Response 114) Meal replacement products typically fall under the 
RACC categories for dairy, specifically the sub-category for shakes and 
shake substitutes, and would need to meet the criteria for those types 
of individual food products in order to bear the ``healthy'' claim. 
Depending on the ingredients, these shakes could also be mixed products 
if there were FGE contributions from different food groups and the FGE 
amounts met the mixed product requirements. In this case, the mixed 
product would have higher added sugars limits (<=10% of the DV) than 
would individual dairy foods (<=5% of the DV). For foods that serve as 
a full meal, the criteria for the meal product category could apply. 
The criteria for meal products are higher than those for individual 
foods and mixed products due to their role in the daily diet as the 
entirety of a meal. For example, meal products have an added sugar 
limit of 20% of the DV. If a shake product is consistent with an entire 
meal, the shake could fall under the meal product category and be 
subject to the higher threshold for added sugars and the other NTL 
provided that the products also met the size and food group 
requirements for meal products. We also note that this a voluntary 
claim and meal replacement products are not limited in how much added 
sugar they can contain based on this rule.

F. Beverages

    (Comment 115) Many comments support FDA's proposal to allow plain 
water and plain, carbonated water without any flavoring or additional 
ingredients to automatically qualify as ``healthy.'' Comments highlight 
that the Dietary Guidelines, 2020-2025 recommends water as a primary 
beverage to be consumed as part of a healthy dietary pattern and 
explain that FDA's proposal reinforces Federal guidance that water is 
an overall healthy choice to maintain hydration and reduce consumption 
of sugar-sweetened beverages. Other comments note the proposal's 
consistency with recommendations in a 2021 Federally commissioned 
report that the National Clinical Care Commission submitted to Congress 
on ``Leveraging Federal Programs to Prevent and Control Diabetes and 
Its Complications'' that encourages the consumption of water, including 
in place of sugar-sweetened beverages. Some comments also state that 
labeling bottled water as ``healthy'' would generally remind consumers 
of the benefits of drinking plain water from any source.
    One comment opposes including calorie-free carbonated beverages 
like carbonated water in the definition asserting that carbon dioxide 
induces a hunger stimulating hormone that can lead to increased food 
consumption and faster weight gain in rats. Another comment states 
that, while sparkling and still water fall into the definition of 
``healthy,'' labeling bottled water ``healthy'' is unnecessary, and FDA 
should focus on foods that are processed or have additives instead. 
Some comments discourage use of the ``healthy'' claim on bottled water, 
raising concerns it could be perceived as claiming bottled water is 
healthier than tap water or potentially take emphasis away from 
ensuring access to safe tap water. The comments voice concerns about 
promoting bottled water due to negative climate and environmental 
impacts resulting from plastic use and bottled water production and 
distribution.
    (Response 115) We agree that plain water and plain carbonated water 
should automatically qualify to bear the ``healthy'' claim. Water 
automatically qualifying for the ``healthy'' claim is appropriate as 
water is necessary for proper functioning of the human body and helps 
consumers choose beverages that fit in a healthy dietary pattern within 
calorie needs. Current nutrition science and Federal dietary guidance, 
as reflected in the Dietary Guidelines, 2020-2025, recommend limiting 
consumption of foods higher in added sugars, which provide excess 
calories to the diet without contributing significant amounts of 
essential nutrients and identify water and sparkling water as beverages 
that are part of a healthy dietary pattern. Bottled plain water and 
plain carbonated water provide calorie-free alternatives to sugar-
sweetened beverages in the marketplace, and bottled water bearing the 
``healthy'' claim can help consumers identify beverages with no added 
sugars and calories.
    As discussed in section V.D.2. (``Saturated Fat''), when developing 
regulations for nutrition-related claims and nutrition labeling, we 
review and consider many sources of scientific evidence, many sources 
of information, and dietary recommendations that may be relevant (e.g., 
conclusions of other expert or international bodies). Findings or 
research that represent consensus of experts in the field or an entire 
body of scientific literature are generally more informative than 
individual studies. We are updating the definition for the claim to 
help consumers maintain healthy dietary practices consistent with the 
current nutrition science and Federal dietary guidance, as reflected in 
the Dietary Guidelines, 2020-2025. The Dietary Guidelines, 2020-2025 
recommend calorie-free beverages, such as carbonated or sparkling 
water, to help people adopt healthy dietary patterns. We disagree that 
calorie-free carbonated water should not qualify to bear the 
``healthy'' claim due to the reported effects of carbon dioxide from a 
single study in rats. We view the Dietary Guidelines, 2020-2025 and its 
many sources of underlying scientific evidence as being more 
informative than a single study in rats for establishing criteria to 
bear the ``healthy'' claim. The comments discouraging use of the 
``healthy'' claim on bottled water due to concerns about the possible 
perception of bottled water as healthier than tap water or potential to 
take emphasis away from ensuring access to safe tap water did not 
provide evidence to support their assertions and do not

[[Page 106130]]

change our view. Comments regarding the environmental impacts of 
bottled water are outside the scope of this rulemaking.
    (Comment 116) Many comments recommend including unsweetened coffee 
(including whole, ground, and roasted coffee beans) and unsweetened tea 
(derived from the Camellia sinensis plant) as beverages that 
automatically qualify to bear the ``healthy'' claim. The comments 
assert that, consistent with the Dietary Guidelines, 2020-2025, these 
products play a role in providing consumers with hydration but will not 
contribute to calories or added sugars intake. The comments assert 
there is strong and consistent research on the health benefits and 
antioxidant content of coffee and tea and also note the products 
include other compounds that the comments characterize as potentially 
beneficial, such as caffeine. The comments cite the 2015 DGAC 
scientific report's conclusion that drinking coffee is associated with 
a reduced risk of cardiovascular disease, diabetes, multiple cancers, 
and all-cause mortality. The comments mentioning tea refer to evidence 
for tea, derived from Camellia sinensis, supporting a beneficial effect 
of flavonoids, specifically flavan-3-ol on cardiometabolic outcomes. 
Some comments distinguish ``herbal tea,'' also referred to as ``herbal 
infusions'' or ``tisanes'' from tea, derived from the Camellia sinensis 
plant. Comments describe ``herbal teas'' and ``herbal infusions,'' 
hereafter referred to as herbal infusions, as a diverse category of 
beverages with about 400 different parts of plants from 300 different 
plants. The comments note that herbal infusions could be from a single 
plant species (e.g., camomile or peppermint) or a mixture of different 
plants that could include tea (Camellia sinensis). These comments 
support allowing unsweetened herbal infusions (flavored or unflavored, 
caffeinated or decaffeinated) to be eligible for the ``healthy'' claim, 
stating that this would incentivize companies to offer additional 
products without added calories or added sugars that can contribute to 
a balanced diet. Some comments note that coffee or tea without added 
ingredients may contain intrinsic calories depending on the nature of 
the coffee bean or tea leaf and the brewing process, but request that 
FDA include such products regardless of intrinsic calorie content.
    (Response 116) We agree that including unsweetened coffee and tea, 
in addition to plain and carbonated water, as beverages that 
automatically qualify to bear the ``healthy'' claim align with beverage 
choices recommended by the Dietary Guidelines, 2020-2025. According to 
the Dietary Guidelines, beverages that are calorie-free, such as water, 
coffee, or tea without added sugar or cream, should be the primary 
beverages consumed. We view evidence submitted by comments on health 
outcomes of coffee and tea to further support the Dietary Guidelines, 
2020-2025 beverage recommendations. Allowing coffee and tea to 
automatically qualify for ``healthy'' could expand consumer choice of 
beverages that help maintain a healthy dietary pattern within calorie 
limits.
    We agree that tea is derived from the plant Camellia sinensis. For 
example, we previously recognized that green tea is made from Camellia 
sinensis in our response to a qualified health claim petition regarding 
the relationship between green tea and certain cancers (Ref. 43). The 
comments state that herbal infusions are derived from an unspecified 
and broad range of plants and plant parts and also include mixtures. It 
is currently unclear how this vast category of beverages from single 
and combinations of unnamed plants and plant parts could help consumers 
maintain healthy dietary practices. At this time, we do not have 
sufficient information to determine whether herbal infusions should 
automatically qualify for the ``healthy'' claim. We therefore extend 
automatic qualification for the ``healthy'' claim to tea--derived from 
Camellia sinensis--and not to herbal infusions.
    While the Dietary Guidelines, 2020-2025 recommends coffee and tea, 
it also highlights some concerns about consuming caffeinated beverages 
(Ref. 1). Caffeine is a stimulant that can occur naturally in foods 
such as tea and coffee or that can be added to beverages. According to 
the Dietary Guidelines, 2020-2025, many people consume caffeine during 
pregnancy or lactation. Caffeine passes to the infant in small amounts 
through breast milk, but usually has no adverse impacts when the mother 
consumes low to moderate amounts (about 300 milligrams or less per day, 
which is about 2 to 3 cups of coffee) (Ref. 1). Those who could be or 
are pregnant should consult their healthcare providers for advice 
concerning caffeine consumption. For healthy adults, FDA has cited 400 
mg/day of caffeine as an amount not generally associated with 
dangerous, negative effects. However, due to general concerns about 
adults consuming over 400 mg/day and concerns about potential negative 
health effects of caffeine for those who may be pregnant or lactating, 
we are not permitting any beverages, including coffee and tea, with 
added caffeine as an ingredient to automatically qualify to bear the 
``healthy'' claim. We view overconsumption of foods labeled as 
``healthy'' as an important topic. We intend to educate consumers to 
help understand how to use the ``healthy'' claim to help build healthy 
dietary patterns and the importance of choosing a variety of nutrient-
dense foods and beverages across all food groups, in recommended 
amounts, while staying within calorie limits, to build a healthy 
dietary pattern consistent with the Dietary Guidelines.
    We decline to allow coffee or tea without added ingredients that 
contain 5 or more intrinsic calories to automatically qualify for the 
``healthy'' claim, as it would be inconsistent with the Dietary 
Guidelines, 2020-2025 recommendations for calorie-free beverages and 
our existing definition of the nutrient content claim ``calorie free.'' 
Our regulations at 21 CFR 101.60(b), state that the terms, ``calorie 
free,'' ``free of calories,'' ``no calories,'' ``zero calories,'' 
``without calories,'' ``trivial source of calories,'' ``negligible 
source of calories,'' or ``dietarily insignificant source of calories'' 
may be used on the label or in the labeling of foods, provided that the 
food contains less than 5 calories per RACC and per labeled serving. 
Thus, given that the recommendation in the Dietary Guidelines that is 
the basis for our inclusion of coffee and tea is limited to ``calorie 
free'' beverages and given our regulatory definition of the nutrient 
content claim ``calorie free,'' only those coffees and teas that 
contain less than 5 calories per RACC and per labeled serving may 
automatically bear the ``healthy'' claim.
    (Comment 117) Many comments support expanding the automatic 
qualification to bear the ``healthy'' claim beyond plain water and 
plain carbonated water to other beverages such as carbonated or 
noncarbonated waters, coffee, and tea that contain certain added 
ingredients such as flavors, non-nutritive sweeteners, vitamins, 
minerals, and electrolytes. The comments posit that these additional 
beverages should be treated the same as plain water and plain 
carbonated water because Federal dietary recommendations encourage 
consumption of these beverages, in part, because they contain no added 
sugars. The comments assert there is no distinction for excluding 
waters with added flavors or non-nutritive sweeteners that are added 
for taste, which do not contribute calories or sugar, but make drinking 
water easier

[[Page 106131]]

and more enjoyable. The comments assert that, by recognizing flavored 
carbonated or noncarbonated waters (including those with non-nutritive 
sweeteners) as ``healthy,'' FDA would be aligning its healthy 
definition with those beverages that are recommended choices under the 
Dietary Guidelines.
    One comment notes the potential for confusion if a healthy claim 
were included on plain and plain carbonated water but not on other 
calorie-free beverages. The comment provides that, to avoid consumer 
confusion, FDA might consider either not permitting water or any 
calorie-free beverages to carry a ``healthy'' claim as they do not 
provide nutrients or a food group, or permit all calorie-free 
beverages, including coffee, tea, flavored waters, and diet sodas, to 
carry a ``healthy'' claim.
    Another comment argues that flavor extracts are exempt from 
nutrition labeling and this exemption supports the use of flavors in 
the definition of ``healthy'' as it shows that we view the significant 
function is for flavoring and is not nutritional. The comment suggests 
that recognizing calorie-free flavored water as ``healthy'' would allow 
companies to offer a variety of beverages with consumer appeal. The 
comments support extending the automatic qualification to these other 
non-caloric beverages asserting it would help people reduce calorie and 
sugar intake, is essential to combatting obesity in the United States, 
would foster hydration, and, in some cases, enhance nutrient intake, 
while allowing for flexibility and the ability for consumers to 
customize their beverage choices to align with a healthy dietary 
pattern.
    Some comments assert that the addition of ``lawful food 
ingredients,'' such as flavors, carbonation, vitamins, minerals, and 
electrolytes to water for taste should not disqualify beverages from 
qualifying as ``healthy'' if they do not add significantly to their 
caloric or sugar content. The comments note that these added minerals 
or electrolytes include potassium, calcium, magnesium, and others, and 
are present at low levels--typically no more than 0.5% of the 
formulation--so their addition does not meaningfully affect the 
composition of the product, other than to slightly affect the taste of 
the water, and it does not affect the calorie or sugar content.
    Some comments request that FDA allow beverages containing at least 
10% of the DV of calcium, potassium, dietary fiber, Vitamin D, or iron 
to qualify as ``healthy.'' Another comment states that FDA should 
include high-fiber beverages without excessive amounts of harmful 
nutrients in the definition of ``healthy,'' suggesting that such 
beverages could be useful in helping Americans meet their recommended 
fiber intake.
    One comment asserts the Dietary Guidelines does not recognize 
fortified bottled waters or beverages such as coffee or tea or 
beverages sweetened with non-nutritive sweeteners as key components of 
a healthful dietary pattern. The comment asserts that such products may 
be formulated in a manner that enables other types of nutrition-related 
claims (e.g., zero calories, sugar-free) but should not be eligible for 
the ``healthy'' claim based on the rationale developed by FDA to link 
the use of this claim more closely to the recommendations in the 
Dietary Guidelines, 2020-2025. Another comment supports such beverages 
being able to bear other types of nutrition-related claims but not the 
``healthy'' claim. The comments assert that other calorie-free 
beverages like soft drinks with artificial sweeteners should not 
qualify for a ``healthy'' claim because they do not contribute to 
nutritional needs.
    (Response 117) We agree with the comments that support expansion of 
the automatic qualification to bear the ``healthy'' claim to non-
caloric beverages, such as carbonated or noncarbonated waters, coffee, 
and tea, containing non-caloric ingredients such as flavors, no- or 
low-calorie sweeteners, vitamins, and minerals. We consider vitamins 
and minerals to include electrolytes or essential minerals such as 
sodium, calcium, and potassium that play a role in many body functions. 
As discussed in section V.D.4 (``Added Sugars''), we consider no- or 
low-calorie sweeteners to include the terms artificial sweeteners, 
high-intensity sweeteners, non-nutritive sweeteners, and non-calorie or 
non-caloric sweeteners. We view the inclusion of certain calorie-free 
ingredients such as flavors, no- or low-calorie sweeteners, vitamins, 
and minerals in waters, coffee, and tea that bear the ``healthy'' claim 
to be consistent with current nutrition science, Federal dietary 
guidance, and our food additive regulations. Allowing certain calorie-
free ingredients such as flavors, no- or low-calorie sweeteners, 
vitamins, and minerals in beverages that may bear the ``healthy'' claim 
can help consumers identify foods that help them to maintain healthy 
dietary practices by providing consumers variety in their beverage 
choices to align with a healthy dietary pattern. We decline to amend 
the rule to permit diet soft drinks or sodas to automatically qualify 
for the ``healthy'' claim. The Dietary Guidelines, 2020-2025 recommends 
non-caloric beverages such as water, coffee, and tea, but does not 
include diet soft drinks or sodas. The Dietary Guidelines, 2020-2025 
explains that both the calories and nutrients that non-caloric 
beverages provide are important considerations. According to the 
Dietary Guidelines, beverages that are calorie-free, such as water, 
coffee, or tea without added sugar or cream, or that contribute 
beneficial nutrients, such as fat-free and low-fat milk and 100% juice, 
should be the primary beverages consumed. Diet soft drinks or sodas do 
not contribute beneficial nutrients and, as mentioned, are not included 
in the Dietary Guidelines, 2020-2025 as recommended calorie-free 
beverage options.
    We decline to modify the criteria to bear the ``healthy'' claim to 
contain a certain amount of the DV for specific vitamins and minerals 
and fiber. In section V.C (``Food Group Equivalents'') and section V.D 
(``Nutrients to Limit''), we discuss our basis for updating the 
``healthy'' claim to be a food group-based approach in addition to NTL 
criteria.
    (Comment 118) Some comments express concerns about water containing 
non-caloric flavors and ingredients and state that if such beverages 
are allowed, FDA should set standards for the types of beverages that 
should qualify (e.g., how much flavoring or sweetener would be allowed, 
which types of non-nutritive or high-intensity sweeteners would be 
allowed).
    Some comments oppose the inclusion of beverages containing low- or 
no-calorie sweeteners, citing research and global public health 
guidance warning against their use. Additionally, some comments state 
that safety data is lacking in children and recommend that children 
under 5 years old avoid low- or no-calorie sweeteners. One comment 
cites a state's prohibition on use of low- and no-calorie sweeteners 
for products served to children and recommends the exclusion of waters 
containing low- or no-calorie sweeteners because there is no way to 
distinguish between child and adult consumption in a retail setting. 
Some comments attribute possible adverse health impacts such as 
cravings for sweet or high-calorie foods and overconsumption of 
sweeteners such as aspartame to consumption of low- or no-calorie 
sweeteners. The comments express concern about the lack of evidence on 
the long-term impacts of low- or no-calorie sweeteners and cite that 
further research is needed to determine the observed associations 
between its consumption and risk for outcomes such as obesity, type 2

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diabetes, cardiovascular diseases, mortality, and unfavorable impacts 
on birthweight and adiposity in offspring. Other comments oppose 
allowing the ``healthy'' claim on calorie-free beverages such as soft 
drinks with artificial sweeteners asserting the proposed rule did not 
discuss the topic of high intensity sweeteners and quote the Dietary 
Guidelines, 2020-2025 when stating ``questions remain about their 
effectiveness as a long-term weight management strategy.''
    (Response 118) We discuss issues of safety and health impacts of 
consuming low- or no-calorie sweeteners in children and adults in 
section V.D.4 (``Added sugars'').
    (Comment 119) Another comment asserts that juice beverages (i.e., 
those containing less than 100% juice) can help contribute to a healthy 
dietary pattern by providing beneficial nutrients and requests we 
develop a more expansive ``healthy'' beverage category. The comment 
recommends we permit juice beverages to bear the ``healthy'' claim if 
they meet the following criteria: (1) contain no added sugar; (2) meet 
the proposed NTL criteria, and (3) contain either a full FGE (including 
products that contain half 100% juice and half water with \1/2\ cup of 
100% juice or one full FGE of fruit) or 10% of the DV per RACC of 
certain nutrients (such as vitamin C, calcium, iron, potassium, vitamin 
D, etc.). The comment also recommends requiring juice beverages must 
meet the fortification policy to bear a ``healthy'' claim, so foods for 
which fortification is discouraged could not qualify.
    (Response 119) We agree that there are beverages other than water 
or 100% juice that can contribute to healthy dietary patterns. Although 
we decline to adopt the specific criteria recommended by the comment, 
in principle, we agree that 100% juices with only the addition of water 
and no added sugars can be part of a healthy dietary pattern. Water 
automatically qualifies for the ``healthy'' claim, and 100% juices with 
only the addition of water (e.g., 100% juices that have been diluted 
with water such that they are 50% juice and 50% water) automatically 
qualify under the single-ingredient exemption (see Response 9). We 
discuss in section V.C (``Food Group Equivalents'') that we are no 
longer requiring that foods bearing the ``healthy'' claim provide 
certain levels of NTE because there has been a shift in nutrition 
science toward overall healthy eating patterns and away from focusing 
on the amounts of individual nutrients consumed that led to the 
corresponding shift in the definition of the ``healthy'' claim. 
Including requirements for minimum amounts of foods from the 
recommended food groups better reflects the overall nutrient content of 
foods and how nutrients in the food groups and subgroups may work 
together as part of a healthy dietary pattern. Similarly, with this 
focus on food groups, the fortification policy is no longer relevant to 
the ``healthy'' claim and we decline to incorporate it into this rule 
(see Response 100).
    (Comment 120) As bottled water will qualify to bear the ``healthy'' 
claim, some comments request that FDA exempt bottled water from 
requiring nutrition labeling if a nutrient content claim such as 
``healthy'' is used. The comments argue that most bottled water is 
exempt from nutrition labeling under Sec.  101.9(j)(4) because it 
contains insignificant amounts of the mandatory nutrients. However, 
this exemption is contingent upon the product not bearing any nutrient 
content claims on its label or in labeling. The comments state that a 
bottled water product that bears the term ``healthy,'' even if 
otherwise exempt from nutrition labeling, would then be required to 
bear nutrition labeling despite the fact that the nutrition information 
would only convey ``zero'' of the mandatory nutrients. The comments 
request that FDA provide enforcement discretion from nutrition labeling 
when a bottled water product that otherwise is exempt from nutrition 
labeling under Sec.  101.9(j)(4) bears a ``healthy'' claim in cases 
where they do not contain calories or other significant levels of 
nutrients.
    (Response 120) We recognize that bottled water as well as certain 
coffee and tea products bearing the nutrient content claim ``healthy'' 
would no longer qualify for the exemption from nutrition labeling 
requirements at Sec.  101.9(j)(4). Although we asked for comment in the 
proposed rule about the eligibility of calorie-free beverages, coffee, 
and tea to bear the ``healthy'' claim, we did not ask for comments 
specifically about the continued applicability of the exemption from 
nutrition labeling provisions under Sec.  101.9(j)(4) and the proposed 
``healthy'' claim. Until such time as we have had the opportunity to 
address this directly in a future rulemaking, we intend to consider the 
exercise of our enforcement discretion with respect to mandatory 
nutrition labeling on waters, coffee, and tea containing less than 5 
calories per RACC that bear the ``healthy'' claim on their labels or 
labeling.

G. The Term ``Healthy'' and Related Terms or Derivatives of ``Healthy''

    (Comment 121) Many comments support finalizing use of the term 
``healthy'' or related terms as an implied nutrient content claim and 
strongly oppose expanding the list of related terms. The comments ask 
that the final rule reaffirm that the definition of ``healthy'' applies 
only to those terms currently defined as derivatives for a ``healthy'' 
nutrient content claim, i.e., ``health,'' ``healthful,'' 
``healthfully,'' ``healthfulness,'' ``healthier,'' ``healthiest,'' 
``healthily,'' and ``healthiness,'' and only in those circumstances 
where the requisite ``nutritional context'' (i.e., an explicit or 
implicit characterization of the level of a nutrient) is present on the 
label. The comments request that, if additional synonyms are included, 
FDA identify the reliable consumer perception evidence upon which it 
relied sufficient to establish that a term is viewed as synonymous with 
``healthy'' to restrict the use of additional terms, adding that 
without such consumer research and an opportunity for public notice and 
comment, FDA lacks authority to regulate the use of other terms under 
the implied nutrient content claim for ``healthy.''
    Some comments request that FDA reconsider permitting any 
derivatives of ``healthy'' and argue that claim should be limited only 
to the term ``healthy'' to further standardize the claim and ensure 
consumer understanding. Some comments recommend removing the terms 
``healthier'' and ``healthiest,'' suggesting these terms are 
hierarchical and comparative and thus not aligned with the original 
intent of demonstrating the ``healthful'' properties of a certain food. 
The comments assert that the terms ``healthier'' and ``healthiest'' 
could cause confusion for consumers, leading them to believe that 
products bearing such terms may meet a higher nutritional threshold 
when this is not the case. One comment recommends we emphasize the 
healthiness of single-ingredient products by establishing a further 
designation, such as ``healthiest'' that is exclusively reserved for 
whole, single-ingredient nuts, nut butters, whole grains, beans, 
legumes, seeds, fruits, and vegetables.
    Some comments urge FDA to include a complete list of related or 
derivative terms in the codified language and clearly state that other 
potentially synonymous terms not otherwise codified will not be 
considered implied ``healthy'' claims such that they can be used 
without meeting the criteria laid out in Sec.  101.65(d). The comments 
assert that, although the proposed rule provides examples of related 
terms for ``healthy,'' the list of examples appears to be without 
limitation and arguably

[[Page 106133]]

could include other terms (e.g., ``wholesome,'' ``nutrient-dense,'' or 
``nutritious''), causing confusion for both manufacturers and consumers 
absent a complete list.
    One comment states that if FDA also regulates terms that are 
synonymous with healthy, restaurants will be constrained in their 
communications to consumers, which will lead to less education and 
access to nutritionally beneficial foods and beverages by inadvertently 
limiting a restaurants ability to communicate to customers through 
menus, menu boards, and other channels.
    (Response 121) As discussed in the 1994 final rule to establish the 
``healthy'' nutrient content claim (59 FR 24232 at 24235), we 
determined that the regulatory definition of ``healthy'' should apply 
to the use of any of its derivatives in a nutritional context. 
Derivatives of ``healthy'' have the same general meaning and 
connotation as this term and, thus, when used in food labeling, may be 
construed by consumers to imply that the products on which they appear 
will be helpful in maintaining healthy dietary practices. After nearly 
30 years of experience with the ``healthy'' nutrient content claim, we 
still conclude that it is appropriate to require that any of the 
derivatives of ``healthy,'' when used in a nutritional context in food 
labeling, must be in accordance with the definition of ``healthy'' in 
Sec.  101.65(d). Accordingly, the final rule, at Sec.  101.65(d)(3), 
provides that the term ``healthy'' or derivative terms ``health,'' 
``healthful,'' ``healthfully,'' ``healthfulness,'' ``healthier,'' 
``healthiest,'' ``healthily,'' and ``healthiness'' can be used 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 the criteria to bear the claim. We 
are amending Sec.  101.65(d)(3) to clarify that the derivatives of 
``healthy'' are ``health,'' ``healthful,'' ``healthfully,'' 
``healthfulness,'' ``healthier,'' ``healthiest,'' ``healthily,'' and 
``healthiness.'' We agree with the comments requesting that we codify 
the complete list of derivatives for ``healthy'' to make clear that 
other terms not otherwise codified will not be considered derivatives 
of the ``healthy'' implied nutrient content claim under Sec.  
101.65(d).
    With regard to the comments concerning potential consumer confusion 
over use of the terms ``healthier'' and ``healthiest,'' which suggest 
these terms are hierarchical and comparative and thus not aligned with 
the original intent of demonstrating the ``healthful'' properties of a 
certain food, the comments did not provide any data or other 
information to support such concerns, and we are therefore unpersuaded 
to change our position. Moreover, after nearly 30 years of experience 
with the ``healthy'' nutrient content claim, we have not been made 
aware of any consumer confusion resulting from any use of these 
derivative terms. As discussed, since the 1994 final rule, we have 
determined that it is appropriate to apply Sec.  101.65(d) to the use 
of the derivatives of ``healthy'' in a nutritional context.
    The comments regarding communications with consumers in restaurants 
are outside the scope of this rulemaking.
    (Comment 122) Some comments argue that FDA should regulate 
additional terms as ``healthy'' claims, suggesting that there are 
several terms other than ``healthy'' and its derivatives that consumers 
may interpret as indicating that the levels of nutrients in a food are 
such that the food may help maintain healthy dietary practices. The 
comments assert that all words that characterize a food's general 
healthfulness, for example, ``nutritious,'' ``nourishing,'' 
``wholesome,'' ``nutritive,'' and ``good for you,'' should be held to 
the uniform criteria as that of the final ``healthy'' definition. The 
comments express concern that such terms could otherwise be unduly 
confusing to consumers if not held to the same standards in the final 
rule. The comments assert that the most obvious of these terms is 
``nutritious'' and its derivatives, such as ``nutrition,'' 
``nutritional,'' ``nutritiously,'' and ``nutritionally'' and additional 
terms include ``nutrient-dense,'' ``good for you,'' ``nourishing'' and 
``wholesome.'' The comments further assert that consumers likely 
perceive these claims as synonymous with ``healthy'' and the claims 
should be regulated as implied ``healthy'' claims and request that FDA 
expressly add ``nutritious,'' ``nourishing,'' ``wholesome,'' and their 
derivatives, and any other equivalent terms, to the final rule as 
examples of terms that are synonymous with ``healthy.'' The comments 
claim that these kinds of terms are relatively pervasive in marketing 
and advertising messages for food products and extending eligibility 
criteria for ``healthy'' to apply to these phrases may help prevent 
replacement of ``healthy'' on food labels with similar terms that are 
not regulated. The comments claim such additional regulation is 
necessary given the public skepticism of the government's regulation of 
food labels and mistrust of some food label claims. The comments assert 
that this, in turn, may help prevent consumer confusion and strengthen 
the consistency and utility of these terms in differentiating foods 
that are most useful in promoting achievement of recommended dietary 
patterns and urge FDA to conduct research to help it determine whether 
to recognize these terms as synonymous with ``healthy'' or to establish 
separate definitions for their use.
    Other comments specifically oppose incorporating additional terms, 
such as wholesome, nutritious, or other similar terms, as synonyms for 
healthy, claiming consumers view those terms differently and that FDA 
has not provided any information or consumer research to establish that 
these terms should be viewed as synonyms for healthy. The comments 
assert that defining ``healthy'' is complex enough without expanding 
the reach of the rule to include other terms that might have competing 
or misaligned meanings.
    (Response 122) As discussed in the 1994 final rule (59 FR 24232 at 
24235), while we recognize that terms such as ``nutritious,'' 
``wholesome,'' and ``good for you'' can be implied nutrient content 
claims when they appear in a nutritional context on a label or in 
labeling, we do not believe that they are necessarily synonymous with 
``healthy.'' We do not have sufficient information to determine whether 
definitions for the terms mentioned in these comments are needed, and 
what those definitions should be. The comments did not provide 
sufficient information on which to develop definitions or to establish 
these terms as synonyms for the term ``healthy.'' Thus, we are not 
extending the definition of ``healthy'' to these terms. However, we 
note that when these terms appear on labels or labeling, they may be 
subject to regulation under the general misbranding provision of 
section 403(a) of the FD&C Act.

H. Nutritional Context

    (Comment 123) Some comments support our proposal to broaden our 
interpretation of when a ``healthy'' claim constitutes a nutrient 
content claim. Other comments express concern that evaluating the use 
of ``healthy'' only in a nutritional context could be exploited by 
companies who would use the word in other contexts to mislead 
consumers. The comments state that if the word ``healthy'' is in the 
brand name or on the front of a food package, the product should meet 
the healthy definition and that anything different is deceptive.
    (Response 123) In the proposed rule (87 FR 59168 at 59181 through 
59183),

[[Page 106134]]

we discuss, among other things, that ``healthy'' is a broad term that 
can have connotations beyond the nutritional properties of a food. We 
proposed to 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. If the term ``healthy'' is used in a nutritional context 
on a label or in labeling, it is an implied nutrient content claim 
which highlights that a food, because of its nutrient content, is 
particularly useful in constructing a diet that is consistent with 
current dietary recommendations. Therefore, such use of the term 
``healthy'' would be subject to the updated ``healthy'' criteria set 
forth in this rule.
    With regard to comments that suggest we regulate all uses of the 
term ``healthy'' as an implied nutrient content claim, we decline to do 
so. The preamble to the 1994 rule explains the reasons for which FDA 
determined that the term ``healthy'' should not be regulated as an 
implied nutrient content claim when not used in a nutritional context. 
Since that time, FDA has not received information on which to conclude 
that consumers would not be able to understand when ``healthy'' is used 
in a context in which it is not an implied nutrient content claim. 
Consequently, we have no reason to believe that consumers would infer 
that the term ``healthy,'' when used outside of a nutritional context, 
would signal that the food has a nutrient profile that would be helpful 
to consumers in structuring a diet that conforms to current 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 profile 
(see 59 FR 24232 at 24234 to 24235). Accordingly, this regulation 
covers 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. However, we note that, even 
outside of the nutritional context, FDA has the authority to ensure 
that ``healthy'' is not used in a misleading manner under section 
403(a)(1) of the FD&C Act.
    (Comment 124) Some comments recommend that ``healthy'' (and related 
terms) be considered an implied nutrient content claim even when used 
as part of a health claim (e.g., ``heart healthy'') or structure-
function claim (e.g., ``brain health''). The comments assert that any 
use of the term ``healthy'' on food labeling should be considered an 
implied nutrient content claim if the product's labeling also includes 
voluntary information about the nutrition content of the food (e.g., if 
another nutrient content claim appears on the package or product 
website) because the average consumer will not understand that the term 
``healthy'' is regulated differently when used as part of a health 
claim, structure/function claim, or implied nutrient content claim. To 
address the potential for consumer confusion, some comments assert that 
all products using the term ``healthy'' as part of a labeling claim in 
any context should be held to the same nutrient criteria.
    In contrast, other comments state that the requirements of the rule 
should not apply to other labeling claims, such as structure/function 
claims, health claims, or other nutrient content claims that use the 
term ``healthy'' and FDA should explicitly state this in the rule. The 
comments note that, for example, structure/function claims often 
reference specific nutrients, however, use of the term ``healthy'' in 
such claims does not characterize the level of nutrient in the food; 
rather, it generally describes the role of the nutrient on the 
structure or function of the body. Some comments recommend FDA clarify 
it does not view compliance with ``healthy'' as a prerequisite for 
making other nutrient content claims, health claims, or structure/
function claims that are subject to different nutritional requirements 
and regulations, or else it could negatively impact use of other 
labeling claims and lead to consumer confusion.
    (Response 124) Section III.A (``Background'') provides a brief 
overview of different types of claims and statements commonly made on 
food labels or in food labeling. While we generally agree with comments 
stating that not all claims that use the term ``healthy'' should be 
subject to requirements of this rule, we note that use of the term 
``healthy'' in a claim or statement on a food label or labeling may 
place the term into a nutritional context, and therefore, would make 
``healthy'' an implied nutrient content claim. We further note that, 
while different nutrition labeling claims have different purposes and 
criteria for their use, a term or statement may be considered to be 
more than one type of claim (e.g., a structure/function claim and a 
nutrient content claim), depending on the context of the use of the 
term or statement in light of the label and labeling as a whole. 
Additionally, other types of claims may be implied or explicit 
information about the nutrient content of the food, and therefore could 
be accompanying material that could put the use of ``healthy'' into a 
nutritional context. As stated in multiple parts of this rule, and 
consistent with FDA's approach to labeling regulation in other 
contexts, FDA considers whether a food product bears a claim, such as 
the ``healthy'' claim, on a case-by-case basis by looking at the claim 
in the context of the label and labeling as a whole.
    (Comment 125) One comment requests that the updated definition of 
``healthy'' expressly exclude trademarks that are registered on the 
Principal Register of the U.S. Patent and Trademark Office (USPTO) that 
include the word ``healthy'' and that FDA confirm that such registered 
trademarks do not misbrand a food product. The comment notes that the 
intent of the rule is to define ``healthy'' as a nutrient content claim 
only when it is used in a nutritional context and asserts that use of 
``healthy'' in a trademark registered on the USPTO's Principal Register 
is used outside of a nutritional context because it is intended to 
signify that the product came from a specific source and not to 
describe the product's nutrient levels.
    The comment also states that FDA lacks statutory authority to 
restrict labeling references to trademarks registered on the Principal 
Register that include the word ``healthy,'' and that the term 
``healthy'' when used in registered trademarks is not false or 
misleading labeling under sections 201(n) and 403(a) of the FD&C Act 
because it does not misrepresent the characteristics or content of the 
food product itself, and its predominant meaning is a source 
identifier. Further, the comment argues that the update to the claim 
would represent a regulatory taking of the intellectual property of 
firms that have been using ``healthy'' in their product brand name.
    (Response 125) We intend to examine whether the use of the term 
``healthy'' on labels and labeling could be considered an implied 
nutrient content claim if any other information on the label or 
labeling, such as other claims, images, or vignettes, puts the term 
into a nutritional context. We disagree that a brand name using the 
term ``healthy'' is primarily a source identifier. As we stated in the 
1994 rule establishing the ``healthy'' claim, nutritional context is 
established ``when the term appears in a brand name that by virtue of 
its use implies that the product is useful in

[[Page 106135]]

achieving dietary recommendations'' (59 FR 24232 at 24235). As we have 
also stated in response to similar comments since 1993, registering a 
trademark with the USPTO does not automatically place the use of 
``healthy'' outside of a nutritional context. (See 58 FR 2372 at 2375, 
specifically stating ``One comment stated that the proposed definition 
for general nutrition claims could have an impact on many proprietary 
trademarks or slogans . . . FDA disagrees that terms such as those 
cited in the comments should be excluded from regulation under section 
403(r) of the act. The agency believes that these terms can be implied 
nutrient content claims when they appear in a nutritional context on a 
label or in labeling.'')
    As stated in other parts of this rule, we will consider the context 
of the use of the term by looking at the label and labeling as a whole. 
This approach is consistent with how FDA considers product or brand 
names on food labels or labeling in other contexts to determine whether 
a food product bears a claim.
    We also disagree that the rule would constitute a taking. The Fifth 
Amendment to the U.S. Constitution prohibits the government from taking 
private property for public use without just compensation. The Supreme 
Court has held that the government effects a ``per se'' taking when it 
physically appropriates property, which is the ``clearest sort of 
taking.'' Cedar Point Nursery v. Hassid, 141 S. Ct. 2063, 2071 (2021). 
It is not clear that trademarks constitute ``private property'' within 
the meaning of the Fifth Amendment's Takings Clause. See, e.g., 
Clemente Props., Inc. v. Urrutia, 693 F. Supp. 3d 215, 247 (D.P.R. 
2023) (``A question raised by the motions before the Court is whether a 
trademark is the type of private property protected by the Takings 
Clause. The question is debatable and far from settled.''). Even 
assuming trademarks do constitute private property under the Takings 
Clause, a regulatory taking occurs where regulations that ``restrict an 
owner's ability to use his own property'' go ``too far.'' Cedar Point 
Nursery at 2071-72. In such cases, a taking may be found based ``on a 
complex of factors, including: (1) the economic impact of the 
regulation on the claimant; (2) the extent to which the regulation has 
interfered with distinct investment-backed expectations; and (3) the 
character of the governmental action.'' Murr v. Wisconsin, 582 U.S. 
383, 393 (2017) (cleaned up) (referred to as the ``Penn Central 
factors'' after Penn Central Transp. Co. v. New York City, 438 U.S. 
104, 124 (1978)). The force of any one of these three Penn Central 
factors may be ``so overwhelming . . . that it disposes of the taking 
question.'' Ruckelshaus v. Monsanto Co., 467 U.S. 986, 1005 (1984).
    Regarding the character of the governmental action, it has long 
been established that the government may regulate products in the 
interests of public health and safety and such regulation ``cannot, in 
any just sense, be deemed a taking.'' Mugler v. Kansas, 123 U.S. 623, 
668 (1887). The takings doctrine is based on the concept that, when the 
government seizes property for the public benefit, such as land for a 
road or a dam, the public should compensate the owner. But that is a 
different scenario from where the government limits the use of property 
to protect public health and safety. See id. at 669. As the Supreme 
Court has elaborated, ``[l]ong ago it was recognized that all property 
in this country is held under the implied obligation that the owner's 
use of it shall not be injurious to the community, and the Takings 
Clause did not transform that principle to one that requires 
compensation whenever the State asserts its power to enforce it.'' 
Keystone Bituminous Coal Ass'n v. DeBenedictis, 480 U.S. 470, 491-92 
(1987) (cleaned up). As a result, restrictions on ``uses of personal 
property'' that are ``directed at the protection of public health and 
safety'' are ``the type of regulation in which the private interest has 
traditionally been most confined and governments are given the greatest 
leeway to act without the need to compensate those affected by their 
actions.'' Rose Acre Farms, Inc. v. United States, 559 F.3d 1260, 1281 
(Fed. Cir. 2009). As we have stated throughout this rule, here the 
updated definition of ``healthy'' directly advances our substantial 
government interests in providing information to consumers to indicate 
that the nutrient content of a food may help them maintain healthy 
dietary practices to promote public health, preventing misleading 
labeling, and reducing consumer confusion potentially caused by the use 
of inconsistent definitions for nutrient content claims. Updating the 
``healthy'' definition to ensure that it is aligned with current 
nutrition science and Federal dietary guidance promotes public health 
by providing consumers with information about foods that, because of 
their nutrient content, are particularly useful in constructing a diet 
that is consistent with current dietary recommendations. Because the 
term ``healthy'' can lead consumers to believe a food will help them 
maintain healthy dietary practices when that term is used as an implied 
claim in a trademarked brand name, the same public health purposes are 
at issue.
    The other Penn Central factors also weigh in favor of finding no 
taking here. With regard to economic impact, the comment asserts that 
the value of the property of food manufacturers with brand names that 
contain the term ``healthy'' will be diminished because some of their 
products bearing the name may no longer qualify for the ``healthy'' 
claim. However, many changes in government laws, regulations, and 
policies have economic consequences, and the Supreme Court has long 
recognized that ``[g]overnment hardly could go on if to some extent 
values incident to property could not be diminished without paying for 
every such change in the general law.'' Pennsylvania Coal Co. v. Mahon, 
260 U.S. 393, 413 (1922). The Supreme Court has explained that ``mere 
diminution in the value of property, however serious, is insufficient 
to demonstrate a taking.'' Concrete Pipe & Prods. v. Constr. Laborers 
Pension Trust, 508 U.S. 602, 645 (1993). Similarly, a ``loss of 
profit'' does not establish a taking. 74 Pinehurst LLC v. New York, 59 
F.4th 557, 566 (2d Cir. 2023). And courts have rejected regulatory 
takings claims even where the government's actions ``impose 
considerable costs on private actors in the regulated industry.'' 
Mobile Relay Assocs. v. FCC, 457 F.3d 1, 12 (D.C. Cir. 2006). Instead, 
in evaluating the economic impact of a regulation, courts have 
explained that the ``touchstone'' is ``proportionality'': ``the size of 
a liability only weighs in favor of finding a taking insofar as it is 
out of proportion to the legitimate obligations society may impose on 
individual entities.'' B&G Constr. Co. v. Dir., OWCP, 662 F.3d 233, 260 
(3d Cir. 2011) (cleaned up). Here, especially given the revisions from 
the proposed rule, we anticipate that some products that include 
``healthy'' in their brand name would continue to qualify for the 
claim, and some others could qualify with appropriate modifications. 
While there may be changes to which products can qualify under the 
updated definition, it is unlikely that any trademarked brand name 
would be destroyed or even substantially restricted. These changes 
would, at most, constitute diminution in the value of property--and the 
comment does not provide evidence regarding how large any diminution in 
the value of the property would be. The comment further acknowledges 
that FDA could make changes to the nutrient and food group levels that 
were specified in the

[[Page 106136]]

proposed rule that would result in more products that currently bear a 
brand name containing the term ``healthy'' continuing to qualify to 
bear the claim. As noted elsewhere in this final rule, FDA made 
multiple changes that increased flexibility from the proposed to the 
final rule, including increasing the added sugar limits for mixed 
dishes, main dishes, and meal products and providing for aggregation of 
food group equivalents.
    With respect to the last Penn Central factor, a ``reasonable 
investment-backed expectation must be more than a unilateral 
expectation or an abstract need.'' Ruckelshaus, 467 U.S. at 1005 
(cleaned up). Courts have held that those who do business in highly 
regulated fields are on notice that changes are possible. Connolly v. 
Pension Ben. Guar. Corp., 475 U.S. 211, 226-27 (1986) (``Those who do 
business in the regulated field cannot object if the legislative scheme 
is buttressed by subsequent amendments to achieve the legislative 
end'') (cleaned up). As described at the beginning of this comment 
response, food manufacturers have been on notice since 1994 that their 
brand names, if making an implied claim, would need to comply with the 
``healthy'' claim definition. As the claim definition is based on 
nutrition science, it is reasonable to expect that the definition would 
be updated over time to match updates in nutrition science and that the 
scope of products that would be able to bear the claim may shift to 
some extent.
    (Comment 126) Many comments oppose our proposal to broaden the 
interpretation of nutritional context, arguing that what they perceived 
to be an overly broad interpretation of nutritional context could cause 
confusion and limit consumer access to relevant information when 
choosing a variety of foods within an overall healthy eating pattern. 
The comments assert that FDA acknowledged in the 1994 rule that the 
various uses of the term ``healthy'' demonstrate the need for us to 
take a flexible case-by-case approach in deciding whether a claim that 
uses the term ``healthy'' is an implied health claim or nutrient 
content claim, and we determined there was insufficient evidence to 
conclude consumers would not be able to discern the context in which 
the ``healthy'' claim appears on the label or labeling of a product. 
The comments state they believe this continues to be the case today and 
that more work and data (e.g., consumer studies) would be needed by FDA 
to justify an expanded definition of nutritional context.
    The comments support what they state is FDA's longstanding position 
that ``healthy'' claims are only implied nutrient content claims when 
made ``in connection with an explicit or implicit claim or statement 
about a nutrient (such as `healthy, contains 3 grams of fat')'' and 
assert that this original standard provides clear parameters for 
determining whether a ``healthy'' claim is an implied nutrient content 
claim, i.e., by requiring a direct nexus between the ``healthy'' claim 
and the nutrient statement. The comments argue that this original 
standard also aligns with FDA's statutory authority under the FD&C Act, 
which authorizes FDA to establish nutrient content claim requirements 
only for claims that characterize the level of any nutrient which is of 
the type required by the FD&C Act to be in the label or labeling of the 
food (section 403(r) of the FD&C Act (21 U.S.C. 343(r)). The comments 
assert that industry has relied upon this standard for more than two 
decades and has developed product portfolios based on these established 
principles and disagree with FDA's proposal to alter this standard, 
arguing that the proposed changes to the interpretation of nutritional 
context would divert from FDA's current standards and would treat a 
broader class of ``healthy'' claims as implied nutrient content claims. 
The comments raise concerns about whether a brand name on the front of 
a label that uses the term ``healthy'' and a separate, back-of-pack 
claim that a product ``provides essential vitamins and minerals'' would 
be treated as an implied nutrient content claim by FDA. Some comments 
argue that only manufacturers who use the term ``healthy'' when 
describing the product's nutritional value should be required to comply 
and that manufacturers who simply use ``healthy'' as a term in the 
product's name-brand, slogan and/or logo/mascot, and who are not 
describing the nutritional content should be allowed to use the term 
without complying with this rule. The comments argue that the proposed 
interpretation of nutritional context would not only exceed FDA's 
statutory authority, but also would fail to advance FDA's policy aim, 
i.e., to ensure that consumers have access to truthful and non-
misleading information to inform healthy dietary choices.
    (Response 126) The minor revisions we are making to Sec.  
101.65(d)(1) defining implied nutrient content claims are consistent 
with FDA's longstanding approach to consider whether a food product 
bears a claim, such as the ``healthy'' claim, on a case-by-case basis 
by looking at the claim in the context of the labels and labeling as a 
whole. The revisions merely clarify that information on the label or 
labeling that puts ``healthy'' into a nutritional context need not be 
immediately adjacent to the implied nutrient content claim. Under the 
rule, we intend to continue using a flexible, case-by-case approach in 
evaluating and considering labeling claims, by placing the use of the 
term ``healthy'' into the context of the overall label or labeling.
    Such revisions are also consistent with FDA's statutory authority 
under the FD&C Act. As explained in section IV. (``Legal Authority''), 
section 403(r) of the FD&C Act specifies that claims made in the label 
or labeling of the food that expressly or by implication characterize 
the level of any nutrient which is the type required by section 
403(q)(1) or (q)(2) of the FD&C Act to be in the label or labeling of 
the food are permitted only if they are made in accordance with FDA's 
authorizing regulations. As early as the 1994 rule, FDA determined 
that, when used in a nutritional context, the term ``healthy'' is 
making an implied claim that the levels of the nutrients in the food 
are such that the food would be useful in achieving a total diet that 
conforms to current dietary recommendations (59 FR 24232 at 24234). 
Consequently, it is squarely within FDA's authority to define implied 
nutrient content claims, such as ``healthy,'' by regulation, to clarify 
when a claim implies that a food, because of its nutrient content, may 
help consumers maintain healthy dietary practices. We therefore 
disagree with the comments that imply that the revisions to Sec.  
101.65(d)(1), which state that ``healthy'' is a nutrient content claim 
where it is used to characterize the food itself and ``where there is 
also implied or explicit information about the nutrient content of the 
food,'' are no longer aligned with FDA's statutory authority under the 
FD&C Act.
    Furthermore, as explained in the proposed rule, the minor revisions 
made to Sec.  101.65(d)(1) bring that provision in line with the 
updated criteria for the ``healthy'' claim. The updated criteria 
incorporate food group requirements in addition to individual NTL 
criteria. Therefore, Sec.  101.65(d)(1) no longer requires that the 
accompanying material be a ``claim or statement about a nutrient,'' but 
instead requires that it be ``information about the nutrient content of 
the food.'' This change recognizes that material that states or implies 
that the nutrient content of the food would be useful to consumers in 
structuring a diet that is supported by current dietary

[[Page 106137]]

recommendations is not limited to statements about the presence/level 
of one specific nutrient and reflects that the updated ``healthy'' 
criteria, along with current nutrition science and Federal dietary 
guidance, emphasize food groups and the overall nutrient content of the 
food, rather than one individual nutrient in isolation.
    Additionally, we disagree with comments stating that FDA should not 
consider use of the term ``healthy'' in a slogan, product name, logo, 
or mascot a nutrient content claim because it is not describing 
nutritional content. As stated above, under the rule, we intend to 
continue applying a flexible, case-by-case approach that considers the 
overall content of the food label and labeling when determining if a 
product label uses the ``healthy'' claim in a nutritional context. 
Contrary to what this comment asserts, this approach furthers FDA's 
goals to help ensure that consumers receive information that may help 
them maintain healthy dietary practices to promote public health, 
prevent misleading labeling, and reduce potential confusion caused by 
the use of inconsistent definitions for nutrient content claims. We 
address additional comments about the statutory authority to expand the 
nutritional context and about whether the requirements of the final 
rule directly advance FDA's asserted interests in section V.K (``Legal 
Comments'').
    (Comment 127) Many comments request that FDA reconsider its 
position that the inclusion of voluntary front-of-pack nutrition icons 
such as Facts Up Front, MyPlate, or other symbols on the label, that do 
not reference nutrients, would be considered ``nutritional context'' 
that would render the term ``healthy'' on the label being subject to 
the ``healthy'' nutrient content claim definition. The comments 
disagree that these labeling elements create a nutritional context. The 
comments assert that the Facts Up Front program represents the 
standardized and factual display of nutrient information about a food 
and does not create any sort of nutritional or health halo for the 
product and that other claims, such as those about whole grain or fruit 
content, do not characterize the nutrient content. The comments note 
that FDA referenced a MyPlate logo as creating nutritional context for 
a ``healthy'' nutrient content claim; however, the comments argue that 
there are a variety of MyPlate symbols, including icons providing an 
overview of food group contributions on a plate (i.e., half fruit and 
vegetables) but also other icons that can be used to signal the food 
groups present (fruits, vegetables, grains, dairy, protein, oils), or 
foods to limit, and even physical activity. The comments suggest that, 
provided they are used with appropriate context and not in a misleading 
manner, these icons do not create the nutritional context for 
``healthy'' to be viewed as an implied nutrient content claim. The 
comments state that FDA has cited no consumer research or evidence to 
suggest that consumers view this type of information as creating a 
nutritional context.
    Some comments state that FDA should acknowledge that mandatory 
label elements, such as a statement of identity, or corporate, company, 
or subsidiary name in a distribution statement, or the Nutrition Facts 
label does not provide the requisite nutritional context for a 
``healthy'' nutrient content claim, provided that the mandatory label 
elements appear on the label in a way consistent with FDA's labeling 
requirements. According to the comments, a company name, which is often 
a mandatory label component, should be able to appear anywhere on pack, 
including the front panel, without being viewed as nutritional context 
for an implied ``healthy'' nutrient content claim. The comments argue 
that corporate and company names are not easily changed, and in most 
cases, represent a large portfolio of products. As such, the comments 
request FDA to include a provision in the final regulation that 
expressly exempts corporate and/or company names from triggering the 
criteria for a ``healthy'' implied nutrient content claim provided that 
the corporate or company name is not otherwise false and misleading in 
the context of the entire label.
    (Response 127) With regard to the use of MyPlate and other related 
graphic icons, we discussed in the proposed rule (87 FR 59168 at 59182) 
that there may 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 voluntary front of pack 
labeling (such as the Facts Up Front labeling program) to imply that 
the product meets nutritional needs. We reiterate that 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. For certain 
graphics mentioned by the comment, such as an ``activity'' button icon 
referring to physical activity, such an icon likely would not provide 
the requisite nutritional context to establish a ``healthy'' claim; 
however, many of the MyPlate graphic representations are voluntary 
information about the food groups present in a food and thus would 
provide the requisite nutritional context to establish an implied 
nutrient content claim. While we are not aware of specific studies 
regarding consumer understanding of whether these specific icons create 
nutritional context, such findings are not necessary to this particular 
determination, as the information contained in the graphic images of 
food groups or a plate with multiple food groups is consistent with our 
stated parameters for limiting our consideration of the term 
``healthy'' as an implied nutrient content claim to instances in which 
it is used in a nutritional context. However, we agree that mandatory 
label elements, such as the statement of identity, corporate name of 
the manufacturer, or the Nutrition Facts label, do not place the use of 
the term ``healthy'' elsewhere on the product into a nutritional 
context.
    (Comment 128) Some comments argue that it is inadequate to only 
consider nutrition criteria when labeling foods ``healthy,'' stating 
that FDA should fully ``repeal'' the ability for companies to use the 
word ``healthy'' until FDA reviews and requires further criteria for 
when foods can be labeled ``healthy.'' The comments suggest, at a 
minimum, that we consider the safety of food additives when determining 
whether a food is ``healthy'' by including requirements that such foods 
do not contain food additives that have been associated with health 
risks. Some comments discuss FDA's ``Closer to Zero'' plan for reducing 
dietary exposure of babies and young children to toxic elements and 
express concern about juice products being eligible for the ``healthy'' 
claim using only ``nutrition-based criteria, without accounting for the 
levels of toxic elements where an FDA action level applies to them.'' 
Similarly, other comments, noting that ``healthy'' will act as a 
nutrient content claim only when used in a nutritional context, 
recommend the inclusion of an accompanying statement such as ``based on 
nutritional content only'' to avoid consumer misconception.
    (Response 128) This final rule defines ``healthy'' as a nutrient 
content claim only when it is used in a nutritional context. As 
explained in the preamble to the proposed rule, since 1994, we have 
recognized that labeling that describes a food product as ``healthy'' 
in a nutritional context is making an implicit claim of the level of 
nutrients in the

[[Page 106138]]

product. The presence or absence of ingredients other than nutrients in 
a food product, as described in the comments (e.g., toxic elements and 
non-nutrient food additives), is outside of the scope of the 
``healthy'' nutrient content claim. However, as the comments note, our 
``Closer to Zero'' plan describes the activities we are currently 
undertaking for reducing dietary exposure of babies and young children 
to contaminants from food (Ref. 35).
    As stated above, we have no reason to believe that consumers would 
infer that the term, ``healthy,'' when used outside of a nutritional 
context, would signal that the food has a nutrient profile that would 
be helpful to consumers in achieving a diet that is consistent with 
current dietary recommendations, and such inferences are only likely to 
be drawn if the term ``healthy'' is accompanied by additional material 
or is otherwise presented in a context that explicitly or implicitly 
suggests that the food has a particular nutrient profile. For this 
reason, it is not necessary to require an accompanying statement to the 
``healthy'' nutrient content claim, such as ``based on nutritional 
content only.''

I. Records Requirements

    (Comment 129) Many comments agree with our proposed requirement 
that food manufacturers of products (other than raw, whole fruits, raw 
whole vegetables, water, and individual foods where the standard 
information required on the food label provides sufficient information 
to verify that the food meets the FGE requirements) that bear the 
``healthy'' claim make and keep written records to verify that the food 
meets the FGE requirements where the FGE contained in the product is 
not apparent from the label of the food. These comments express support 
for the flexibility we proposed for manufacturers to demonstrate 
compliance using records they believe best meet the requirements rather 
than being required to produce any specific form or documents. The 
comments note that such an approach is similar to FDA's recordkeeping 
system for nutrition labeling of added sugars and other nutrients for 
which no analytical test methods exist. The comments agree that 
updating the definition of ``healthy'' and requiring each manufacturer 
to make and keep written records to verify the food meets the 
definition supports the overall goal of promoting a healthier food 
supply for all. However, some comments argue that FDA does not have 
legal authority to access proprietary information, such as complete 
product formulation, and state that FDA should clarify that records 
kept to verify the food group contributions are limited in nature and 
need only include the specific information regarding the food group 
contribution information, rather than the full recipes or formulations 
that are confidential and trade secret information.
    (Response 129) We disagree with the assertion that FDA does not 
have legal authority to access proprietary information such as complete 
product formulation. As discussed in section IV. (``Legal Authority''), 
the authority granted 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 
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 to be kept 
under Sec.  101.65(d)(4). Failure to make and keep records and provide 
the records to FDA, as described in Sec.  101.65(d)(4), would result in 
the food bearing the ``healthy'' claim being misbranded under section 
403(r) and 403(a)(1) of the FD&C Act.
    However, as discussed in the preamble to the proposed rule (87 FR 
59168 at 59194), manufacturers will be responsible for the type of 
records they maintain and are not required to produce any specific form 
or document. We proposed that records be kept as original records, true 
copies (such as photocopies, pictures, scanned copies, microfilm, 
microfiche, or other accurate reproductions of the original records), 
or electronic records in accordance with 21 CFR part 11 and the records 
must be accurate, indelible, and legible. The manufacturer is in the 
best position to know which records provide the documentation required 
to determine compliance. In the preamble to the proposed rule (87 FR 
59168 at 59194), we note that compliance with the requirements for NTL 
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. 
In addition, for some foods, we will 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. Other foods will not need to provide 
records to document compliance because the single ingredient exemption 
in the final rule expands the types of foods that can automatically 
qualify for the ``healthy'' claim without needing to meet criteria for 
FGEs and NTL (see Response 9). Records used to verify that a food meets 
the FGE 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 FGE 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 to bear the claim. The 
records requirement is intended to provide flexibility in what records 
the manufacturer makes available to FDA to verify the claim. The 
records provided to FDA during an inspection would only need to provide 
information on the FGEs because, as discussed above, the information on 
NTL will be available on the food package. Most importantly, other 
information about the food can be redacted to ensure confidentiality of 
a food product formulation as long as the information provided can 
adequately verify compliance with the requirements to bear the 
``healthy'' claim. Furthermore, even if a manufacturer's records 
contained confidential commercial information or trade secret 
information or a manufacturer believes that certain information should 
be protected from public disclosure, there are safeguards to protect 
against public disclosure of that information and mechanisms that a 
manufacturer can use to assert that certain information should be 
protected from disclosure. We protect confidential information from 
disclosure, consistent with applicable statutes and regulations, 
including 5 U.S.C. 552(b)(4), 18 U.S.C.

[[Page 106139]]

1905, and part 20 (21 CFR part 20). For example, our regulations 
pertaining to disclosure of public information, at part 20, include 
provisions that protect trade secrets and commercial or financial 
information which is privileged or confidential. If a manufacturer 
keeps proprietary recipe information in its records, it should mark the 
information as such before providing the records to FDA upon request.
    (Comment 130) Some comments request that we recognize that records 
may be stored centrally and need not be physically available at the 
manufacturing facility and that allowing for central storage of records 
would be consistent with the approach FDA has taken in numerous other 
situations, citing 21 CFR 117.315(c).
    (Response 130) Records must be made available to us upon request, 
during an inspection, for official review and photocopying or other 
means of reproduction (Sec.  101.65(d)(4)). As discussed in the 
proposed rule (87 FR 59168 at 59196), 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.
    (Comment 131) Some comments request clarification regarding which 
party is responsible for keeping records in a situation where a 
contract manufacturer produces a product on behalf of another party and 
maintains the product recipe as confidential and proprietary, 
suggesting that it should be sufficient if the manufacturer provides to 
the distributor/own-brand company a signed statement confirming that 
the product is eligible for the ``healthy'' definition.
    (Response 131) Companies using the ``healthy'' claim on their 
products may maintain the required records however they choose, 
including whatever arrangements they have with manufacturing partners, 
provided they are aware that they are responsible for ensuring that the 
products they introduce into interstate commerce are not misbranded 
under the FD&C Act. As discussed in the previous response, if FDA 
inspects a manufacturer or manufacturing facility, the relevant records 
to demonstrate that a food meets the requirements for bearing the 
``healthy'' claim would need to be provided within a reasonable time, 
such as someone providing the records electronically to FDA, if 
appropriate. As described above, redacted records are also potentially 
appropriate to maintain, provided the redacted records are able to 
demonstrate that the food meets the requirements for bearing the 
``healthy'' claim. A signed statement confirming that the product is 
eligible for the ``healthy'' claim would not be sufficient to provide 
to FDA during an inspection to demonstrate that a food product 
qualifies to bear the ``healthy'' claim.
    In the preamble to the proposed rule (87 FR 59168 at 59195), we 
also discussed how manufacturers should be able to obtain the necessary 
information from ingredient suppliers to demonstrate that any foods 
they manufacture that bear the ``healthy'' claim meet the requirements 
for the claim.
    (Comment 132) Some comments suggest that FDA provide further 
clarity around calculating values for the designated thresholds, 
stating in instances where the requirements cannot be verified with the 
label and manufacturers have to maintain information in records to 
determine whether the product meets the FGE requirements, food 
formulators/food companies need clarification regarding whether 
unrounded values would need to be at or above thresholds and to what 
decimal place. Some comments urge FDA to clarify that either unrounded 
or rounded nutrient values may be used to determine compliance, 
suggesting that this would be consistent with FDA's approach for other 
absolute nutrient content claims such as ``fat free,'' where FDA 
indicated that ``because there is no nutritional difference between 
rounded and unrounded values of a nutrient in a food, [FDA] does not 
see a need to specify which value should be used in determining whether 
or not a food qualifies to make a nutrient content claim'' (see 58 FR 
44020 at 44024 (August 18, 1993).) The comments claim that the same 
standard should apply to the updated ``healthy'' nutrient content claim 
definition because ``healthy'' is an absolute claim, where either the 
rounded or unrounded value could be used to assess compliance.
    (Response 132) We agree with the comments and our previously stated 
position that because there is no nutritional difference between 
rounded and unrounded values of a nutrient in a food, we do not see a 
need to specify which value should be used in determining whether a 
food qualifies to bear the ``healthy'' nutrient content claim. As the 
comments note, this is consistent with our position in the final rule 
``Food Labeling: Nutrient Content Claims, General Principles, 
Petitions, Definition of Terms; Definitions of Nutrient Content Claims 
for the Fat, Fatty Acid, and Cholesterol Content of Foods; Food 
Standards: Requirements for Foods Named by Use of a Nutrient Content 
Claim and a Standardized Term; Technical Amendment'' (58 FR 44020, 
August 18, 1993).
    (Comment 133) The comments assert that the rule should be 
accompanied by mechanisms to ensure food manufacturers adequately keep 
records and catalog the nutritional components of their foods to abide 
by the updated ``healthy'' standards. Some comments argue that the 
proposed recordkeeping requirements to ensure manufacturers are 
following the regulations seem to leave enforcement and compliance in a 
state of ambiguity and call for increased transparency regarding 
enforcement of compliance from food manufacturers. Some comments claim 
that the proposed rule involves limited recordkeeping requirements that 
entails non-standardized forms of evidence showing that combination 
foods and grains labeled as ``healthy'' meet FDA standards but there is 
no explicit information on how often inspections take place or how 
these records are verified for accuracy. Similarly, some comments argue 
that there is also no indication of what consequences are for failing 
to be compliant, claiming that with evidence that manufacturers have 
intentionally misrepresented labels in the past, it is essential for 
this action to be transparent regarding enforcement and consequences 
for lack of compliance.
    (Response 133) As discussed in the proposed rule (87 FR 59168 at 
59194), where the requirements cannot be verified using the label, the 
manufacturer will have or should have the information required to 
determine whether the product meets the criteria for bearing the 
``healthy'' claim. The information contained in manufacturers' records 
must be accurate 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 conclude that the records will 
provide FDA with the necessary means to determine compliance with the 
criteria for bearing the ``healthy'' nutrient content claim. We are 
requiring that records 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). 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

[[Page 106140]]

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 note that 
having a false declaration on the label is a violation of section 
403(a)(1) of the FD&C Act. In addition, providing false information in 
records to FDA may also be a potential criminal violation under 18 
U.S.C. 1001. Under 18 U.S.C. 1001, whoever, in any matter within the 
jurisdiction of the executive, legislative, or judicial branch of the 
Government of the United States, knowingly and willfully: (1) 
Falsifies, conceals, or covers up by any trick, scheme, or device a 
material fact; (2) makes any materially false, fictitious, or 
fraudulent statement or representation; or (3) makes or uses any false 
writing or document knowing the same to contain any materially false, 
fictitious, or fraudulent statement or entry may be subject to a fine 
or imprisonment.

J. Effective and Compliance Dates

    (Comment 134) Many comments support the proposed compliance date 
that is 3 years after the effective date (i.e., 60 days after the date 
the final rule publishes in the Federal Register) stating that this 
would provide adequate time for compliance. Some comments recommend 
that FDA revise the effective date to make it the same as the date the 
final rule is published in the Federal Register rather than 60 days 
after to allow manufacturers already in compliance with the rule to 
voluntarily label their products ``healthy'' as soon as possible. 
Similarly, some comments suggest that FDA provide enforcement 
discretion for products that elect to use the ``healthy'' term in 
compliance with the new definition prior to the compliance date. Some 
comments request an effective date that is the same at the compliance 
date (i.e., 3 years after issuance of the final rule), stating that 
this is allowed under FDA's administrative regulations, which require 
that the effective date be at least 30 days after publication of the 
final rule, but do not restrict longer effective dates. Some comments 
urge FDA to confirm that ``healthy'' may be used during the compliance 
period consistent with the original regulation and that providing an 
effective date that is the same as the compliance date would reinforce 
that the original ``healthy'' definition may appropriately be used in 
the period after the final rule is issued and before the compliance 
date.
    Some comments request that FDA recognize the compliance date as 
applying to the date a product is manufactured and labeled rather than 
the date it is introduced into interstate commerce, arguing that this 
is less confusing for distribution systems and easier to implement. The 
comments state that this would be consistent with how FDA has 
approached other labeling changes (i.e., considering the compliance 
date to apply to the date a food was labeled).
    (Response 134) The comments suggest there may be some confusion 
with regard to the meaning of the effective date. The effective date is 
the date on which the Office of the Federal Register amends the Code of 
Federal Regulations in Sec.  101.65(d) to reflect the new requirements 
for the ``healthy'' implied nutrient content claim as promulgated by 
this final rule. The effective date for this final rule is 60 days 
after the date of the final rule's publication in the Federal Register. 
The compliance date--meaning the date on which we would begin enforcing 
the rule--is 3 years after the effective date. As explained in the 
proposed rule, 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. However, 
although companies are not required to be in compliance with the new 
requirements for the ``healthy'' implied nutrient content claim until 
the date that is 3 years after the effective date, a company is free to 
choose to relabel in accordance with the new requirements sooner, as 
discussed further in section V.K (``Legal Comments'').
    With regard to the comments requesting that we recognize the 
compliance date as applying to the date a product is labeled rather 
than the date it is introduced into interstate commerce, we agree. 
Compliance with the updated definition of ``healthy'' in Sec.  
101.65(d) will be assessed for products that are labeled (i.e., when 
the label is placed on the product) with the ``healthy'' implied 
nutrient content claim on or after the compliance date (3 years after 
the effective date). We will not begin to enforce the updated final 
rule requirements before the compliance date. We evaluate the date the 
food product was labeled for purposes of determining whether the 
product must meet the updated requirements.
    Further, as discussed in response to comment 161 below, 
manufacturers would not be required to comply with requirements of the 
final rule until the compliance date. Thus, once any new requirements 
for the definition of the nutrient content claim ``healthy'' are in 
effect, manufacturers could either comply with the new requirements or 
continue to use the original definition of ``healthy'' until the 
compliance date.
    (Comment 135) One comment asserts that the compliance date would be 
difficult to meet due to the workload and costs associated with the 
rule. One comment argues that the time period before the rule takes 
effect should allow food manufacturers time to update their packaging 
and change their recipes to comply with the ``healthy'' definition to 
avoid damage to their brand. One comment suggests that FDA set a 
compliance date for small businesses that is 2 years after the proposed 
compliance date and use that period to educate small businesses on the 
rule and associated compliance issues, arguing that small businesses 
are at a disadvantage compared to large companies. One comment asserts 
the rule would benefit large consumer packaged goods companies that 
have the financial means to accommodate relabeling their products, thus 
placing small businesses at a competitive disadvantage because the rule 
would have disproportionate impacts on small businesses, and requests 
accommodations for small businesses relating to compliance and the 
provision of education resources.
    (Response 135) FDA has gone through an extensive and transparent 
rulemaking process to update the definition of the ``healthy'' claim 
and has established a generous compliance period for manufacturers to 
come into compliance. Although one comment did suggest an additional 2 
years (or a total of 5 years) is needed, we do not have information 
that would enable us to determine whether all or merely some small 
businesses need additional time to comply with the rule, nor do we have 
information that would enable us to determine how much, if any, 
additional time is needed for small businesses generally. If we were to 
extend the compliance date for all small businesses to 5 years, 
consumer confusion could result because different versions of the 
``healthy'' claim would exist in the market for a longer period of 
time. The differences could frustrate, rather than enhance, the 
consumer's ability to maintain healthy dietary practices and 
potentially undermine public confidence in use of the claim. We also 
note that businesses may choose to include a ``healthy'' claim on food 
product labeling that meets the criteria in this rule, but are not 
required to do so, and that our estimates indicate that only a small 
number of products will need to relabel or reformulate their

[[Page 106141]]

products to comply with the new definition (see Ref. 39).

K. Legal Comments

1. Statutory Authority
    (Comment 136) One comment agrees that FDA has the authority to make 
changes to the ``healthy'' definition according to the most recent 
science. While some comments acknowledge that the FD&C Act ``allows FDA 
to define terms that expressly or implicitly characterize the nutrient 
content of a food,'' where the nutrients are those required to be 
labeled within the Nutrition Facts label, other comments argue that the 
statute does not give FDA authority to require foods bearing nutrient 
content claims to have a minimum amount of food group equivalents. 
Another comment asserts that FDA knew or agreed it did not have 
authority to include food groups in this context because we have not 
done so in the past. Another comment states that FDA's food group 
criteria are ``nutrient-agnostic'' and therefore outside of the scope 
of section 403(r) of the FD&C Act.
    (Response 136) We disagree with the comments that included an 
overly narrow reading of section 403(r)(1)(A) of the FD&C Act. As 
discussed above, 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 which is 
of the type required . . . to be in the label or labeling of the 
food.'' (section 403(r)(1)(A) of the FD&C Act). FDA regulations define 
``implied nutrient content claims,'' in part, as claims that ``suggest[ 
] that [a] food, because of its nutrient content, may be useful in 
maintaining healthy dietary practices,'' (Sec.  101.13(b)(2)(ii)). As 
we stated in the 1993 final rule establishing this claim, ``a claim 
that a food, because of its nutrient content, may be useful in 
maintaining healthy dietary practices is clearly a claim that 
characterizes the level of nutrient in that food. The claim is 
essentially saying that the level of nutrients in the food is such that 
the food will contribute to good health'' (58 FR 2302 at 2375, January 
6, 1993). Therefore, the ``healthy'' claim by implication characterizes 
the level of nutrients in a food, and as such, the claim must be made 
in accordance with FDA regulations under section 403(r) of the FD&C 
Act.
    Although the comments advocate for a narrow interpretation of the 
statute, the Supreme Court has embraced broad constructions of the FD&C 
Act based on the Court's understanding of its text, congressional 
intent, and remedial purpose. See, e.g., United States v. Bacto-
Unidisk, 394 U.S. 784, 798 (1969) (``Congress fully intended that the 
[FD&C] Act's coverage be as broad as its literal language 
indicates.''); United States v. Dotterweich, 320 U.S. 277, 280 (1943) 
(``The purposes of [the FD&C Act] thus touch phases of the lives and 
health of people which, in the circumstances of modern industrialism, 
are largely beyond self-protection. Regard for these purposes should 
infuse construction of the legislation if it is to be treated as a 
working instrument of government and not merely as a collection of 
English words.''). Moreover, Congress may ``expressly delegate to an 
agency the authority to give meaning to a particular statutory term'' 
and to ``prescribe rules to `fill up the details' of a statutory 
scheme.'' Loper Bright Enters. v. Raimondo, 144 S. Ct. 2244, 2263 
(2024) (cleaned up). The best reading of the NLEA is that Congress 
``delegate[d] discretionary authority'' to FDA. Id. Relevant provisions 
appear throughout section 403(r) and specifically in section 
403(r)(2)(A)(i) of the FD&C Act, which requires nutrient content claims 
to ``use[ ] terms which are defined in regulations of the Secretary.'' 
Therefore, the best reading of sections 403(r)(1)(A) and 
403(r)(2)(A)(i) of the FD&C Act is that they delegate discretionary 
authority to FDA to decide, as appropriately informed by its technical 
expertise and within the limits of its statutory authority, how 
particular claims may characterize the level of any nutrient in a food.
    The food group equivalent criteria included in the updated 
definition of ``healthy'' help ensure that foods bearing the 
``healthy'' claim have a nutrient profile that may help consumers 
maintain healthy dietary practices, in line with the definition and 
purpose of this implied nutrient content claim. Each food group that is 
part of the food group equivalent requirements represents the inclusion 
of multiple important nutrients. 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, 
consistent with current nutrition science. By requiring products to 
contain a certain amount of a food group, the rule will help ensure 
foods bearing the ``healthy'' claim contain a variety of important 
beneficial nutrients and, therefore, that their labeling provides non-
misleading information that assists people who wish to choose foods 
that will meet recommended nutrient intakes and maintain healthy 
dietary patterns.
    Accordingly, consistent with Congress's objectives to provide 
appropriate nutritional information to consumers, the statutory phrase 
``characterize[ ] the level of any nutrient which is of the type 
required . . . to be in the label or labeling of the food'' is best 
understood in light of current science to encompass both limits on 
certain individual nutrients and food group criteria that more broadly 
incorporate a variety of nutrients from nutrient-dense foods. The 
updated ``healthy'' claim implicitly characterizes the level of a 
number of nutrients that are of the type required to be declared on the 
Nutrition Facts label. As we explained in the proposed rule and 
elsewhere in this final rule, the updated definition of this implied 
claim, consistent with current dietary guidelines, includes food groups 
that represent a number of different nutrients and the claim is thus 
characterizing the overall nutrient content of the food, rather than 
focusing on one individual nutrient in isolation, for example, as with 
an express nutrient content claim.
    Thus, we also disagree that our previous definition of, or examples 
regarding, the ``healthy'' claim indicate that FDA did not believe it 
had the authority to go beyond individual nutrients in the context of 
the implied ``healthy'' claim to focus on food groups in addition to 
specific nutrient levels. The changes made by this rulemaking are due 
to evolving science, not a change in FDA's understanding of its legal 
authority. For years, FDA has defined ``healthy'' in the context of the 
overall characteristics of foods as they contribute to building a 
healthy dietary pattern and the definition has used a number of 
nutrient levels. 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 
(previously Sec.  101.65(d)(2)(i)). As discussed elsewhere in this 
document, in recent years the Dietary Guidelines have shifted from 
focusing on such individual nutrients 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 
(Ref. 1). Thus, the way various nutrients are counted for the 
definition of the ``healthy'' claim has been updated to account for 
that evolution in nutrition science. The reference in the statute to

[[Page 106142]]

``characteriz[ing] the level of any nutrient'' and the reference in the 
regulation to ``maintaining healthy dietary practices'' incorporate a 
scientific component because both the characterization and the 
assessment of healthy dietary practices involve an evaluation of the 
impact of diet on health. And, as science has evolved over time, the 
understanding of an implied claim that a food contains levels of 
nutrients that aid in maintaining healthy dietary practices should also 
evolve. To ensure that such a claim is not misleading, avoids consumer 
confusion, and continues to assist people who wish to choose foods 
whose nutritional content contributes to good health, FDA has concluded 
that the definition of the claim should be updated to match the current 
scientific understanding of the underlying facts. Thus, it is 
appropriate and consistent with the statutory and regulatory framework, 
including Congress's express delegation of rulemaking authority to the 
Agency to define terms in nutrient content claims, for FDA to update 
definitions related to implied nutrient content claims based on current 
science, including the ``healthy'' claim, which FDA has long regulated 
as an implied nutrient content claim. To the extent that this 
rulemaking entails a change in the exercise of our statutory authority, 
it is justified by these advances in nutrition science that have led to 
broader recommendations, including in the Dietary Guidelines and as 
discussed in greater detail throughout this final rule and the proposed 
rule, to explicitly refer to food groups as a way to build a healthy 
dietary pattern (see Home Care Ass'n of Am. v. Weil, 799 F.3d 1084 
(D.C. Cir. 2015) (stating the Administrative Procedure Act (APA) 
imposes ``no special burden when an Agency elects to change course'' 
and the ``reasoned explanation'' under the APA for an alternative 
approach includes an Agency awareness of the change in position and 
good reasons for the change (citing FCC v. Fox Television Stations, 
Inc., 556 U.S. 502, 515 (2009)).
    (Comment 137) One comment argues that the use of the phrase 
``maintain healthy dietary practices'' is outside of the FD&C Act's 
nutrient content claim authority, as section 403(r) of the FD&C Act 
only focuses on levels of specific nutrients in a food.
    (Response 137) This comment misunderstands the implied nutrient 
content claim scheme that has been in place since 1993 and the 
statutory basis for it. First, as we quoted above, the 1993 final rule 
stated that ``a claim that a food, because of its nutrient content, may 
be useful in maintaining healthy dietary practices is clearly a claim 
that characterizes the level of nutrient in that food. The claim is 
essentially saying that the level of nutrients in the food is such that 
the food will contribute to good health'' (58 FR 2302 at 2375). 
Therefore, the comment is incorrect in asserting that this standard is 
irrelevant for nutrient content claims, especially implied claims. 
Additionally, section 403(r) of the FD&C Act itself uses the phrase ``. 
. . will assist consumers in maintaining healthy dietary practices'' to 
describe the basis for certain types of nutrient content claims (see, 
e.g., section 403(r)(2)(A)(ii)(II) and (r)(2)(A)(iii)(I) of the FD&C 
Act). Moreover, we have found that ``Congress was clearly concerned 
with such claims. The October 24, 1990, proceedings in the Senate show 
that one purpose of the 1990 amendments was to regulate the use of 
nutrient content claims that appear on food labels and labeling to help 
consumers make appropriate dietary choices (136 Congressional Record 
S16610 (October 24, 1990))'' (see 58 FR 2302 at 2375). Ensuring that 
the information presented to consumers on food labels can help 
consumers identify foods that will help them maintain a healthy diet 
has been a part of our authority under both sections 403(q) and 403(r) 
of the FD&C Act since the passage of the 1990 NLEA Amendments.
    Further, the original definition of the ``healthy'' claim at Sec.  
101.65(d)(1)(i) has specifically included language about helping 
consumers maintain healthy dietary practices since it was finalized in 
1994. This is not new language, but instead aligns with the statutory 
and regulatory framework that has been applied for almost 30 years 
since the inception of the claim.
    (Comment 138) One comment argues that by broadening the basis on 
which the ``healthy'' claim can be put in a nutritional context and 
focusing on the overall characteristics of a food, rather than a tie to 
a specific level of an individual nutrient, FDA no longer has the 
statutory authority to regulate the ``healthy'' claim.
    (Response 138) We disagree that the minor changes to the 
description of how FDA assesses, on a case-by-case basis, whether a 
claim ``expressly or by implication'' characterizes the level of any 
nutrient, places ``healthy'' outside the scope of a nutrient content 
claim as described in section 403(r) of the FD&C Act. As discussed 
above in Response 136, under section 403(r) of the FD&C Act, nutrient 
content claims include both express and implied claims that 
characterize the level of any nutrient which is of the type required to 
be in the label or labeling of a food. Additionally, claims that 
characterize the level of nutrients in the food include claims about 
the overall nutrition profile of the food. This is especially true for 
defined implied nutrient content claims like ``healthy,'' where, since 
the relevant regulations were issued, FDA's focus has been on foods 
that are useful in creating a diet consistent with dietary 
recommendations because of their nutrient content. Nothing in the FD&C 
Act requires a reference to a specific level of one individual nutrient 
to impliedly characterize the level of any nutrient in the food as 
directed by section 403(r) of the FD&C Act (see Response 136 for 
further discussion).
    (Comment 139) One comment discusses our statutory authority in 
setting nutrient to limit thresholds, asserting that, in setting these 
thresholds, we must ground the types and levels of such nutrients on a 
``permitted'' statutory basis, specifically referring to either section 
403(r)(2)(A)(vi) or 403(r)(2)(B) of the FD&C Act.
    (Response 139) This comment misstates the statutory authority for 
setting the nutrient to limit thresholds within the definition of the 
``healthy'' claim. The statutory basis, as discussed in previous 
responses (e.g., Response 136), is section 403(r)(1)(A) of the FD&C Act 
as well as section 403(r)(2)(A)(i) of the FD&C Act. Section 403(r)(2) 
of the FD&C Act sets out specific requirements for making defined 
claims and states that a claim, such as ``healthy,'' may be made only 
in accordance with FDA regulations defining the term. The limitations 
for added sugars, sodium, and saturated fat are part of the definition 
of the term ``healthy.'' In contrast, the limitations on nutrients 
described in section 403(r)(2)(A)(vi) and 403(r)(2)(B) of the FD&C Act, 
referenced by the comment, refer to ``another nutrient in the food'' 
rather than the nutrients actually incorporated into the definition of 
the claim, and are not relevant here.
    (Comment 140) Some comments say that we did not present support for 
the added sugars limits set forth in the proposed rule to demonstrate 
that added sugars amounts above those limits would reflect the amounts 
at which a ``healthy'' claim would become ``misleading.'' Furthermore, 
some comments suggest that we could only set limits for added sugars if 
there was a determination by the Secretary of HHS that these limits 
reflect the levels at which added sugars increase the risk of a disease 
or health-related condition

[[Page 106143]]

that is diet related in the general population.
    (Response 140) We disagree that FDA must demonstrate that added 
sugar amounts above the limits set forth in the rule would reflect the 
amounts at which a ``healthy'' claim would become ``misleading'' or 
that a level of added sugars has a direct link to chronic disease under 
section 403(r) of the FD&C Act. The primary purposes behind section 
403(r) of the FD&C Act and FDA's nutrient content claim regulations are 
to provide information to consumers that may help them maintain healthy 
dietary practices, to help prevent misleading labeling, and to reduce 
consumer confusion potentially caused by the use of inconsistent 
definitions for nutrient content claims. Preventing misleading labeling 
is only one of these purposes. The updated regulation for the 
``healthy'' claim defines the claim with standardized criteria, such as 
the added sugars limit, for use on foods that useful in creating a diet 
that is consistent with dietary recommendations, to ensure that 
consumers are adequately informed and not misled. Furthermore, there is 
no requirement, under the statute or First Amendment jurisprudence, 
that limits FDA's authority over nutrient content claims to only 
regulating claims shown to be inherently or actually misleading. Nor is 
there any legal requirement that FDA determine that a nutrient increase 
the risk of a disease or health-related condition that is diet related 
in the general population in order to include limits for such nutrients 
as part of the regulatory definition for a nutrient content claim. 
While section 403(r)(2)(B) of the FD&C Act does refer to a nutrient at 
a level that increases the risk of diet-related diseases or health-
related conditions in the general population, this provision is in the 
context of a required disclosure statement regarding a nutrient that is 
not the subject of the nutrient content claim and is therefore not 
relevant to FDA's authority to set criteria as part of a nutrient 
content claim definition.
    (Comment 141) Several comments argue that we have statutory 
direction to follow the Dietary Guidelines, with one comment citing 7 
U.S.C. 5341(a)(1) FD&C Act, and argue that FDA is not authorized to 
implement rules that deviate from the Dietary Guidelines' 
recommendations, including in setting the added sugars and sodium 
limits.
    (Response 141) We disagree with the comments that FDA is deviating 
from the Dietary Guidelines in a way that is not permitted by statute. 
The provision cited by the comment, 7 U.S.C. 5341(a)(1) of the FD&C 
Act, states that the Dietary Guidelines ``shall be promoted by each 
Federal agency in carrying out any Federal food, nutrition, or health 
program.'' The cited provision, 7 U.S.C. 5341(a)(1) of the FD&C Act, 
does not elaborate on what it means for Agencies to successfully 
promote the Dietary Guidelines through their work and, further, there 
is nothing in 7 U.S.C. 5341(a)(1) of the FD&C Act that states that an 
Agency may not make any independent scientific considerations in 
rulemaking. Because we relied on and incorporated the recommendations 
in the current edition of the Dietary Guidelines in developing the 
final rule, as a result, the ``healthy'' rule promotes the Dietary 
Guidelines. The entire focus of the healthy rule is identifying foods 
that can be the foundation of building a healthy dietary pattern as 
specified in the Dietary Guidelines, 2020-2025. For example, 
modifications to the NTL thresholds were made for foods that are 
identified as underconsumed and promoted by the Dietary Guidelines, 
2020-2025, such as nuts and seeds and seafood.
    Beyond this one citation to a general provision about ``promoting'' 
the overall Dietary Guidelines, the comments that raise this issue do 
not point to any statutory requirement, such as in section 403(r) of 
the FD&C Act, that FDA follow the Dietary Guidelines or statutory 
language that states that FDA is not authorized to deviate from any 
individual recommendation in the Dietary Guidelines. Overall, the 
changes made to update the ``healthy'' criteria are consistent with 
current nutrition science and Federal dietary guidance, including the 
Dietary Guidelines. We have made certain adjustments to the baseline 
criteria to provide additional flexibility, to reflect practical 
realities (e.g., marketplace conditions), consistent with the purpose 
of the ``healthy'' claim. Thus, there is no violation of any statutory 
directive regarding the Dietary Guidelines in the rule.
    (Comment 142) One comment questions whether added sugar is a 
``nutrient'' as the basis for an argument that FDA may not have the 
authority to include added sugars levels as part of a nutrient content 
claim definition. While acknowledging that there is no regulatory 
definition of ``nutrient,'' the comment states that other nutrients 
used in section 403(r) of the FD&C Act are ``chemically and 
structurally distinct from each other and have different physiological 
effects on the body.''
    (Response 142) We disagree that FDA does not have the authority to 
include added sugars levels as part of a nutrient content claim 
definition. First, section 403(r) of the FD&C Act states that nutrient 
content claims ``characterize'' the level of any nutrient which is of 
the type required by paragraph (q)(1) or (q)(2) [of section 403 of the 
FD&C Act] to be in the label or labeling of the food.'' Added sugars, 
thus, are a nutrient as described in section 403(r) of the FD&C Act 
because, pursuant to regulation, the amount of added sugars is required 
to be declared under section 403(q)(2)(A) of the FD&C Act (see 81 FR 
33742 at 33801 through 33803 adding added sugars to the list of 
required nutrients to be declared on the Nutrition Facts label under 
section 403(q)(2)(A) of the FD&C Act). Therefore, limiting the amount 
of added sugars in a food is an appropriate criterion for a nutrient 
content claim under section 403(r) of the FD&C Act.
    Given the statutory language in section 403 of the FD&C Act, 
whether other nutrients that are the subject of section 403(q) of the 
FD&C Act are chemically and structurally distinct from each other and 
have different effects on the body is not relevant to the analysis of 
whether added sugars is a nutrient as described in section 403(r) of 
the FD&C Act. Additionally, even if it were relevant, FDA does not 
agree that all the other nutrients are distinct in this way. For 
example, the listed section 403(q) of the FD&C Act declarations include 
broad categories (like total carbohydrates and total fat) and subsets 
of those categories (like fiber and saturated fat), which are clearly 
not entirely distinct. Thus, this argument is not persuasive.
2. Administrative Procedure Act (APA)
    (Comment 143) One comment argues that it was arbitrary for FDA to 
incorporate FGEs into the definition of ``healthy'' because consumers 
will not be able to determine why the food qualifies for the claim or 
if the claim was made in error.
    (Response 143) The purpose of the ``healthy'' claim is to help 
manufacturers provide information to consumers so that they can easily 
and quickly identify foods that are particularly useful in helping them 
build a healthy diet. The comment does not provide any explanation of 
why consumers need to be able to determine the basis for qualification 
for the ``healthy'' claim at the point of decision-making about a food. 
The basis for the ``healthy'' criteria is explained in the rule, which 
will help consumers understand what foods qualify for the ``healthy'' 
claim and whether foods are labeled with the claim when they should not 
be. We also plan to conduct consumer education regarding the

[[Page 106144]]

updated definition of the ``healthy'' claim to support consumers in 
their use of the claim to identify foods with which to build their 
healthy diets.
    Although the rule will help consumers be better informed about 
which foods can help form the basis of a healthy diet, FDA recognizes 
that consumers may not have access to all documentation supporting the 
healthy claim for each individual product that they purchase. This is 
similar to many labeling requirements, and the fact consumers may lack 
some kinds of information does not mean that the rule is arbitrary or 
does not serve the goals of better informing consumers and preventing 
them from being misled (see Home Box Office, Inc. v. FCC, 567 F.2d 9, 
36 n. 58 (D.C. Cir. 1977), cert. denied, 434 U.S. 829 (1977) (``In 
determining what points are significant, the `arbitrary and capricious' 
standard of review must be kept in mind . . . only comments which, if 
true, raise points relevant to the agency's decision and which, if 
adopted, would require a change in an agency's proposed rule or cast 
doubt on the reasonableness of a position taken by the agency.'')).
    (Comment 144) A comment suggests that FDA's rationale for allowing 
food groups to have different baseline nutrient thresholds is an 
``arbitrary inconsistency'' that should be addressed by making the 
baseline thresholds the same for all food groups. Several comments 
argue that FDA setting different baseline threshold limits for 
different nutrients, ``not having a consistent methodology'' for 
calculating the thresholds and providing flexibility for some food 
categories and not others made FDA's approach to NTL arbitrary and 
capricious. One comment asserts that we have failed to satisfy the 
arbitrary and capricious standard that has been described in the case 
law.
    Several comments argue specifically that the nutrient limits for 
whole grains are lower than and do not provide the same flexibility as 
the limits for certain meats, nuts, eggs, and seafood, resulting in an 
arbitrary difference without an adequate rationale. Another comment 
argues that allowing added sugars in dairy and whole grain products, 
but not in fruit and vegetable products, is an arbitrary difference.
    (Response 144) We note at the outset that arbitrary and capricious 
claims under the APA are reviewed under the APA's ``narrow'' and 
``deferential'' arbitrary and capricious standard. Motor Vehicle Mfrs. 
Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 
(1983); FCC v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021). 
The court ``simply ensures that the agency has acted within a zone of 
reasonableness'' and ``has reasonably considered the relevant issues 
and reasonably explained the decision.'' Prometheus Radio Project, 141 
S. Ct. at 1158. In addition, courts should ``give[ ] a high level of 
deference to [FDA's] scientific judgments.'' Pharm. Mfg. Rsch. Servs., 
Inc. v. FDA, 957 F.3d 254, 262 (D.C. Cir. 2020). In this rulemaking, 
FDA has provided a thorough explanation of its scientific judgment on 
these issues (see sections V.C. (``Food Group Equivalents'') and V.D. 
(``Nutrients to Limit'')).
    We disagree with the characterization in the comments that we did 
not have a consistent methodology for establishing the nutrient to 
limit amounts in the rule. As described in section V.D (``Nutrients to 
Limit''), we started with a <=5% DV limit for each nutrient to limit 
based on the amount that has historically been associated with the 
nutritional advice of what is considered to be ``low'' in any nutrient, 
as well as, in some cases, what would qualify the food for a ``low'' 
nutrient content claim, such as saturated fat. Some minor adjustments 
to the established baseline limits were made as necessary to help 
consumers maintain healthy dietary practices and for consistency with 
the Dietary Guidelines, such as increasing the saturated fat limit to 
<=10% DV for fat-free and low-fat dairy so that those foods could 
qualify for ``healthy'' as they are recommended by the Dietary 
Guidelines (see section V.D.2 (``Saturated Fat'')). As explained 
further in section V.D.3 (``Sodium''), it was determined that a <=5% DV 
limit would be too low for sodium given the functions of sodium in 
foods and current levels of sodium in the food supply, so an adjustment 
was made to have a baseline sodium limit of <=10% DV. Accordingly, we 
have provided a reasoned scientific basis for each decision in the 
rulemaking and these adjustments were thoroughly reasoned and 
consistent with the statutory purpose.
    Further, contrary to the comment's assertion, the difference 
between how meat, eggs, seafood, and nuts as compared to how whole 
grains were treated in the proposed rule was carefully explained, 
including based on consistency with the Dietary Guidelines (see 
sections V.D.2 (``Saturated Fat'') and V.D.4 (``Added Sugars'') for 
further discussion). The final rule provides additional flexibilities 
for other products after additional information was provided about 
adjustments that would help consumers maintain healthy dietary 
practices. Similarly, FDA has explained the reasons why some amounts of 
added sugars were able to be included in certain products and not 
others. We also note that some of the added sugars limits have been 
adjusted in the final rule, such as accommodating small amounts of 
added sugars in fruit and vegetable products, thus minimizing the 
difference noted by the comment. See section V.D.4. (``Added Sugars'').
    (Comment 145) One comment asserts that the nutrient to limit 
thresholds are arbitrary because FDA did not demonstrate their 
connection to chronic disease risk or any other level at which a food 
becomes unhealthy. Another comment asserts that because the amount of 
added sugars is not directly related to chronic disease risk, there is 
no reason for the added sugars limit to be lower than that of sodium.
    (Response 145) The comment's references to chronic disease risk or 
the level at which an individual food becomes ``unhealthy'' are 
misplaced. Determining a level at which individual foods become 
``unhealthy'' would be inconsistent with current nutrition science and 
our numerous previous statements in a variety of contexts that all 
foods can be incorporated into a healthy dietary pattern. As discussed, 
this implied nutrient content claim describes a food that, because of 
its nutrient levels, will help consumers maintain healthy dietary 
practices. The NTL thresholds are used to identify foods that will be 
the foundation or building blocks of a healthy dietary pattern and are 
specifically not designed to be a level at which a particular food 
becomes ``unhealthy.'' See section III. (``Background'') for more on 
this issue. Determining a level at which foods become ``unhealthy'' 
would be inconsistent with current nutrition science and our numerous 
previous statements in a variety of contexts that all foods can be 
incorporated into a healthy dietary pattern. Claims like ``healthy'' 
help consumers identify which foods are the foundation of building a 
healthy dietary pattern.
    Similarly, impact on chronic disease risk is not the basis for the 
``healthy'' claim. While maintaining healthy dietary practices will 
likely lead to reduced chronic disease risk in the case of diet-related 
diseases, the purpose of labeling, such as the ``healthy'' claim, is to 
provide information to help consumers choose foods that can help them 
build a healthy dietary pattern. This recognition does not make FDA's 
position arbitrary--far from it, FDA has made reasoned, rational 
choices for the limits for each nutrient included in the definition 
based on current nutrition science and Federal dietary guidance.

[[Page 106145]]

    We further note that the rationales for the added sugars and sodium 
limits are discussed at length in both the proposed rule (87 FR 59168 
at sections VI.A.2.C. and VI.A.2.B) and elsewhere in this final rule 
(see sections V.D.4 (``Added Sugars'') and V.D.3 (``Sodium'')) and, as 
stated above, the definitions of nutrient content claims are not 
related to chronic disease risk, but to expressly or impliedly 
characterizing the levels of the nutrients in the food.
    (Comment 146) One comment argues that the added sugars thresholds 
are arbitrary because we failed to articulate a consistent rationale 
for them. Another comment asserts that FDA lacked justification for its 
added sugars limit and therefore had not met the ``reasoned basis'' 
required by the APA.
    (Response 146) We provided a reasoned scientific rationale for the 
added sugars limits in the proposed rule (87 FR 59168 at section 
VI.A.2.C) and in the final rule (see section V.D.4 (``Added Sugars'')). 
The proposed rule explained that while there is not a nutrient content 
claim for added sugars on which to begin to base our determination of 
the threshold levels for added sugars in the ``healthy'' claim, we were 
instead able to draw justification for the baseline level from 
consistency with how we were treating the other NTL like saturated fat.
    The proposed rule explained that while there is not a nutrient 
content claim for added sugars on which to begin to base our 
determination of the threshold levels for added sugars in the 
``healthy'' claim, we were instead able to draw justification for the 
baseline level from consistency with how we were treating the other NTL 
like saturated fat.
    Once we had established an appropriate baseline limit, we went on 
to describe our reasoning each time a variation from the proposed 
baseline level of added sugars was determined to be appropriate based 
on market conditions, consumption patterns, or how added sugars are 
used in certain food groups. For example, while the baseline amount of 
added sugars to qualify for the ``healthy'' claim was proposed at 5% 
DV, we described in the proposed rule how added sugars usually are not 
present in vegetable, fruit, and protein products. We also stated our 
rationale for the variation in the section regarding fruit, that we did 
not want the addition of added sugars to such otherwise nutrient-dense 
food products (87 FR 59186).
    We also note that, in response to comments, the final rule raises 
the added sugar limits for the vegetable, fruit, and protein food 
groups to accommodate small amounts of added sugars, which comments 
explained can be used to balance flavors when there is variation in 
natural sweetness of crops, or in sauces, seasonings and other recipe 
components. We also raised the added sugar limit for the whole grain 
food group based in part on comments that described the current market 
conditions such that a majority of recommended whole grain cereal 
products were unable to qualify to use the claim as proposed. Each of 
these adjustments were carefully considered and reasoned in crafting 
the final rule.
    (Comment 147) One comment argues that a frozen vegetable product 
with a sauce and 300 mg of sodium being unable to qualify for the 
``healthy'' claim because the amount of sodium is more than 230 mg is 
an arbitrary result when the foods (vegetables) are ones that consumers 
should be encouraged to select.
    (Response 147) As stated previously, the goal of updating the 
criteria for a food being labeled with the ``healthy'' claim is to 
provide consumers with information to help them identify foods that are 
the foundation of a healthy eating pattern and the DGAs recommend 
nutrient-dense forms of foods to build a healthy dietary pattern. 
Although frozen vegetables can be nutrient-dense, including sodium in 
excess of the limits set in the rule makes a food one that may not be 
able to be used routinely in a foundational way. Labeling such a 
product as ``healthy,'' accordingly, would not serve the purposes of 
this rule--to help consumers have information to build healthy dietary 
patterns. This is particularly so when consumers have options for 
nutrient-dense forms of frozen vegetables that do not contain sodium in 
excess of the limits established for the ``healthy'' claim. Thus, that 
frozen vegetable products with sauces that exceed the sodium threshold 
do not qualify for the ``healthy'' claim is not arbitrary but is based 
on the scientific evaluation of how much sodium can be accommodated in 
a healthy dietary pattern and in the foundational foods that can be 
used to build such a diet. Additionally, as noted elsewhere in the 
rule, such products could be marketed with other claims describing 
their benefits that are not false or misleading.
    (Comment 148) One comment asks FDA to market test the revised 
requirements to ensure they do not arbitrarily exclude nutrient-dense 
foods, such as small RACC foods, in violation of the APA. Another 
comment specifically argues that applying added sugars limits across a 
wide range of RACCs/serving sizes establishes arbitrary and overly 
restrictive requirements for foods with larger RACCs/serving sizes and 
would disqualify many nutrient-dense foods, including those that are 
encouraged by the Dietary Guidelines, from bearing the ``healthy'' 
claim.
    (Response 148) Although we disagree with any assertion that the 
proposal was arbitrary in how the requirements were constructed, we 
have revised the final rule in light of a number of comments that 
raised concerns about the inability of foods with small RACC sizes to 
qualify for the claim under the proposed criteria because such foods 
would not have enough FGEs. In the final rule, we revised the 
requirements regarding the way small RACC foods can calculate FGEs, as 
discussed in Response 8, as well as expanding the exemption for raw 
fruits and vegetables to all single-ingredient foods, which will result 
in a number of small RACC foods qualifying without needing to address 
FGE requirements at all. These changes address the concern that this 
comment is expressing and result in more nutrient dense foods with 
small RACCs qualifying for the claim. We note that we also conducted a 
review of products currently available in the marketplace to help 
support our decisions to make changes to address issues such as this 
one raised in comments.
    The application of the added sugar limits to foods with different 
serving sizes is also not arbitrary under the APA. Regardless of the 
size of the food product, it is the amount of added sugars being 
contributed to the diet that is the subject of the claim definition. 
Therefore, there is a reasoned basis for the added sugar limit, 
consistent with the stated purpose of the claim, to help consumers 
identify foods that are useful in creating a diet consistent with 
dietary recommendations. An added sugars limit for foods to qualify for 
the claim will help consumers stay under the recommended daily limit 
for this nutrient. Regardless of the size of the food product, it is 
the amount of added sugars being contributed to the diet that is the 
subject of the claim definition. Further, nutrient-dense foods, as 
described by the Dietary Guidelines, by definition have limited amounts 
of added sugars, so it is not likely that a nutrient-dense food that is 
recommended by the Dietary Guidelines would not be able to meet the NTL 
amounts specified in the final rule.
    (Comment 149) Several comments argue that the proposed rule 
deviates from the Dietary Guidelines and nutrition science without a 
``convincing'' justification and that such

[[Page 106146]]

a deviation violates the APA. One comment further asserts that there 
are ``scant'' explanations for the deviations from the Dietary 
Guidelines in the proposed rule. Another comment opines that the 
different levels of added sugars allowed in different food categories 
are arbitrary and deviate from the Dietary Guidelines.
    (Response 149) FDA disagrees that we did not provide justification 
or explanations for the requirements set forth in this rule that differ 
from the recommendations in the Dietary Guidelines. As a preliminary 
matter, and as discussed further in response 140, FDA is not required 
to precisely follow the Dietary Guidelines. Consistent with 7 U.S.C. 
5341(a)(1) of the FD&C Act, the definition of ``healthy'' established 
in this rule ``promote[s]'' the Dietary Guidelines. But it is true 
that, as explained elsewhere in this rule, in certain instances FDA 
determined that a deviation for the recommendations in the Dietary 
Guidelines was warranted to serve the purposes of this rule.
    FDA provided a reasoned justification for each of the criteria for 
bearing the claim ``healthy'' that differ from the recommendations in 
the Dietary Guidelines. The APA only requires that Agencies provide ``a 
rational connection between the facts found and the choice made.'' 
(Motor Vehicles Mfrs. Ass'n of the United States Inc. v. State Farm 
Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)). While current nutrition 
science and the Dietary Guidelines have provided the foundation for the 
revisions to the definition of ``healthy,'' FDA determined that certain 
deviations from the Dietary Guidelines were appropriate based on 
various considerations, such as consumer consumption patterns, our 
marketplace review of nutrient-dense foods encouraged by the Dietary 
Guidelines, or consistent evidence of beneficial health effects (i.e., 
that underlie qualified health claims or health claims) (see, e.g., 
sections V.C. (``Food Group Equivalents'') and V.D.2 (``Saturated 
Fat'')). For each such deviation, FDA provided a justification. For 
example, as discussed in Response 32, the Dietary Guidelines, 2020-2025 
discussed alternatives to dairy and, at the time the Dietary Guidelines 
was published, the only beverage that it identified as having a 
nutritional profile similar to cow's milk was soy-based, so the Dietary 
Guidelines specifically recommended the example of soy-based dairy 
alternative beverage products. In this rule, we include other plant-
based beverages that have a similar nutrition profile to cow's milk in 
the beverage alternatives that can qualify for the ``healthy'' claim in 
the dairy category. While the Dietary Guidelines did not specifically 
recommend these other products, we found no reason to exclude these 
other beverages when they have the same nutrient profile as cow's milk, 
as the focus here is on the nutrient levels present, and they can serve 
as useful choices to maintain healthy dietary practices consistent with 
the purpose of the claim.
    (Comment 150) One comment argues that FDA has not provided an 
adequate basis for its proposal to depart from the NTE approach that 
has been in place for decades, by basing this decision on reducing 
indiscriminate fortification. Another comment asserts that eliminating 
the NTE criteria was arbitrary, that there were internal 
inconsistencies in the limits FDA set for the NTL, and that FDA failed 
to justify those limits and the FGE requirements for combination 
products, citing Dist. Hosp. Partners, L.P. v. Burwell, 786 F.3d 46, 59 
(D.C. Cir. 2015) (agency action arbitrary and capricious if it is '' 
`internally inconsistent and inadequately explained' ''); Bus. 
Roundtable v. SEC, 647 F.3d 1144, 1153 (D.C. Cir. 2011) (vacating rule 
that was ``internally inconsistent and therefore arbitrary'').
    (Response 150) We disagree that we did not provide an adequate 
basis for eliminating the NTE as part of the definition of the 
``healthy'' claim. The comment asserts incorrectly that FDA based this 
decision solely on reducing indiscriminate fortification. FDA 
recognizes that it is aware of and discussed the concern with 
indiscriminate fortification, but the comment ignores the explanation 
provided above and in the proposed rule regarding the reasons for 
changing the definition of the ``healthy'' claim--namely the shift in 
nutrition science toward overall eating patterns and away from focusing 
on the amounts of individual nutrients consumed. That definitional 
changed involved, in part, replacing specific NTE with FGEs, as already 
addressed in section V.C (``Food Group Equivalents'').
    The comment does not specify how it believes the levels for the NTL 
are internally inconsistent, but in both the proposed rule and here in 
the final rule, FDA has provided lengthy discussion and justification 
for the qualifying levels set for the NTL for all types of products. 
Specifically for combination products, FDA has laid out the basis for 
how each limit was determined and how foods can satisfy the criteria if 
those foods can serve as a mixed product, main dish, or meal product. 
For example, after detailing how the sodium limit for individual foods 
was set at 10% DV and how that baseline level is consistent with sodium 
reduction efforts and the current status of the food supply, the 
proposed rule explained each time there was a variation from the 
baseline level for a particular food group or subgroup why the value 
was adjusted from the baseline (e.g., 5% instead of 10% DV for salad 
dressings and oil-based spreads because of their small RACC size). 
Then, for combination products, the proposed rule further explained how 
the NTL levels for each of the food groups in the product would be 
averaged together for mixed products and added together for main dishes 
and meal products. This consistent approach was taken for each of the 
NTL in the proposed rule. In this final rule, FDA streamlined and 
further standardized these requirements so that manufacturers do not 
need to consider as many different nutrient levels when looking to 
calculate whether they meet the NTL criteria for their products. This 
change was made in response to a number of comments that requested more 
simplicity (see section V.E (``Combination Foods'')). The final rule is 
internally consistent and has a reasoned basis for each of the values.
    Additionally, the citations to the two cases regarding internal 
inconsistency are misplaced for the reasons provided above. Every 
decision about the nutrient limits and FGEs was consistently made to 
further the goal of helping consumers identify foods that are 
particularly useful in building a healthy dietary pattern consistent 
with current dietary recommendations. In certain cases, different 
levels for different nutrients or different food groups were determined 
to best further this goal because of factors like current market 
conditions and consumer consumption patterns. This difference in 
nutrient levels does not make the rule or its justifications internally 
inconsistent, but rather makes them narrowly tailored to achieving the 
rule's goals.
    (Comment 151) Several comments assert that the APA prohibits FDA 
from implementing the proposed rule because of its overly narrow 
definition of the word ``healthy'' and arbitrarily restrictive labeling 
standards.
    (Response 151) The comments do not explain the basis for the 
assertion that the ``narrowness'' and ``restrictiveness'' of the 
definition of the claim ``healthy'' is arbitrary or capricious under 
the APA. Elsewhere in the rule, for example, in Response 143, we have 
explained why the definition is not arbitrary or capricious under the 
APA. As we have stated previously, the ``healthy'' claim is voluntary 
and has

[[Page 106147]]

been defined by regulation since 1994 for use when it suggests that the 
food is useful in creating a diet consistent with dietary 
recommendations. It is not arbitrary to restrict the use of this claim 
to foods that meet nutritional parameters consistent with current 
dietary recommendations in nutrition science and Federal dietary 
guidance and it is not overly narrow to tailor the definition to ensure 
that the claim only appears on the labels of foods that will help 
consumers achieve these dietary recommendations, given the current food 
marketplace and consumption patterns.
    (Comment 152) One comment argues that it is illogical that an 
ingredient could be used in an authorized health claim but at the same 
time disqualify a food from bearing the ``healthy'' claim.
    (Response 152) Health claims provide information about a specific 
food substance and a specific disease, while the ``healthy'' nutrient 
content claim provides information to help consumers identify foods 
that are foundational to establishing and maintaining healthy dietary 
practices consistent with current nutrition guidance. These are 
different purposes and there may be times where a health claim 
discusses a specific benefit, such as reducing dental caries, but the 
food may not meet the broader criteria for the ``healthy'' claim due to 
nutrient levels that are not consistent with the purpose of the 
``healthy'' claim.
3. First Amendment
    (Comment 153) Some comments say that the use of the ``healthy'' 
claim on products that do not meet the updated regulatory criteria to 
bear the claim are truthful, non-misleading commercial speech that is 
protected by the First Amendment. One comment asserts that FDA cannot 
narrowly define a term and then conclude that any other use of that 
term is misleading. Another comment says that the use of the 
``healthy'' claim on non-compliant products cannot be false or 
misleading because a large number of products that would be excluded 
from the proposed definition of ``healthy'' are products that are 
currently promoted by the Dietary Guidelines. Other comments say that 
FDA has not provided evidence that using the ``healthy'' claim for 
foods that comply with the original regulations is false or misleading.
    (Response 153) We disagree with these comments to the extent that 
they suggest that updating the definition of ``healthy'' will restrict 
truthful and non-misleading speech. The intention behind the statutory 
and regulatory requirements for nutrient content claims on food labels 
or labeling, including any ``healthy'' claims, is to help ensure that 
consumers are adequately informed and not misled by such claims so that 
they can identify foods that may help them maintain healthy dietary 
practices. It is appropriate and consistent with the statutory and 
regulatory framework for FDA to update the definition of ``healthy'' 
based on current science to help ensure that the claim remains truthful 
and non-misleading. As we have explained since 1994, the use of 
``healthy'' constitutes an implied claim that a food, ``based on [its] 
nutrient levels, [is] particularly useful in constructing a diet that 
conforms to current dietary guidelines'' (see 59 FR 24232 at 24233). 
When dietary guidelines change, a formerly truthful and non-misleading 
``healthy'' claim can become misleading if it no longer accords with 
those guidelines. Thus, contrary to the suggestions in the comments, 
updating the ``healthy'' definition in light of that current science is 
necessary to ensure that the use of the claim does not lead consumers 
astray. Indeed, Congress' purpose in enacting this legislation was to 
help ensure that consumers are not misled and that they can make 
informed nutritional choices without confusion caused by the use of 
claims with inconsistent meanings.
    Through the Nutrition Labeling and Education Act (NLEA) of 1990, 
Congress granted FDA the authority to regulate nutrient content claims 
because it recognized that consumers were being misled by the use of 
inconsistent and confusing terms on food labeling. See, e.g., 136 Cong. 
Rec. H5836, H5840 (July 30, 1990) (statement of Rep. Waxman) (``[Under 
the NLEA,] content claims would have to be consistent with terms 
defined by . . . the Food and Drug Administration. Today, companies use 
terms such as `low' and `light' differently and inconsistently. . . . 
The bill would correct this deceptive and misleading state of affairs 
by requiring that terms such as `light' have a single meaning.'') and 
id. at H5843 (statement of Rep. Madigan) (``Consumers today are 
confronted with a variety of labels that provide them with disjointed 
and confusing information. . . . In the past few years, important 
scientific evidence has been repeatedly reported that clearly links 
dietary habits to good health. For this reason, the need to provide 
consumers with better information about the foods they eat is 
important.''); see also 136 Cong. Rec. H12951, H12953-54 (October 26, 
1990) (statement of Rep. Madigan) (``[T]he bill requires that content 
claims such as light, low, et cetera, would have to be consistent with 
terms defined by the FDA. This is to address the current problem of 
companies using these terms differently and inconsistently.''). As 
discussed at length in the preamble to the proposed rule and in section 
IV (``Legal Authority''), the NLEA created section 403(r) 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 the type required by section 
403(q)(1) or (2) of the FD&C Act 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) and (r)(2)(A) of the FD&C 
Act). Such claims are referred to as ``nutrient content claims'' (87 FR 
59168 at 59174). By taking this approach in the NLEA, Congress 
permitted only those nutrient content claims that FDA defines or 
approves. 58 FR 2302, 2392 (January 6, 1993); see also 136 Cong. Rec. 
S06607, S16608 (October 24, 1990) (statement of Sen. Metzenbaum) 
(``[FDA] is required to define in regulations the terms which may be 
used to characterize the level of a nutrient in food. In determining 
which terms to allow, the Secretary should consider the different ways 
such terms are used today. . . . By considering current uses and 
current consumer understanding, the Secretary can best decide how to 
define the term under this bill.''). To assist consumers in maintaining 
healthy dietary practices, and to ensure that claims in food labeling 
do not mislead them, Congress granted FDA broad authority to develop 
appropriate definitions for nutrient content claims. See id. at S16609 
(statement of Sen. Metzenbaum).
    Shortly after the NLEA was passed, in 1994, FDA issued an 
implementing regulation in which we defined ``healthy'' when the term 
is used as an implied nutrient content claim. We explained that we 
determined that, when used in a nutritional 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 maintaining healthy dietary practices and 
achieving a total diet that conforms to current dietary recommendations 
(56 FR 60421 at 60423). Therefore, since 1994, our regulations have 
included an established definition for the ``healthy'' nutrient content 
claim, which highlights that a food, because of its nutrient content, 
is particularly useful in

[[Page 106148]]

constructing a diet that is consistent with to current dietary 
guidelines.
    In line with its statutory authority, FDA has given the nutrient 
content claim ``healthy'' a definition with a ``special and particular 
meaning'' (Am. Acad. of Pain Mgmt v. Joseph, 353 F.3d 1099, 1108 (9th 
Cir. 2004)). As such, the use of the nutrient content claim ``healthy'' 
without meeting the established criteria is at least potentially 
misleading, because it may convey to consumers and the public that 
FDA's established definition for the term has been met, which it has 
not (see id.). As we have said previously, ``because nutrition claims 
are of great importance to the public,'' they have ``a greater 
potential to be deceptive,'' and they are ``difficult for consumers to 
verify independently'' (58 FR 2302 at 2394). FDA's efforts to establish 
and update the criteria for the ``healthy'' nutrient content claim are 
reflective of its statutory mandate to standardize nutrition and 
health-related terms on food labels or labeling, by regulation, for the 
benefit of consumers.
    To the extent that these comments suggest that FDA did not provide 
evidence demonstrating the need to update the definition for the 
``healthy'' nutrient content claim, we also disagree. FDA provided 
evidence throughout the proposed rule that the existing definition of 
``healthy'' is outdated and in some ways inconsistent with current 
nutrition science and Federal dietary guidance (see, e.g., 87 FR 59168, 
59172 at section IV.B., ``Need to Update `Healthy' ''). The proposed 
rule provides, among other things, that the existing definition relies 
on nutrients that were of sufficient public health significance to 
warrant their inclusion on the nutrition label in 1994, when the final 
rule was published, and FDA has issued final rules updating the 
nutrition information on food labels in various ways since then to be 
consistent with nutrition science over time. It also discusses how the 
Dietary Guidelines have changed to focus on the importance of dietary 
patterns as a whole and replacement of less healthy food choices with 
nutrient-dense foods and provided examples of certain foods that are 
encouraged by the Dietary Guidelines that cannot bear the ``healthy'' 
claim under the existing definition (id.). The proposed rule explained 
that, in light of evolving nutrition science and Federal dietary 
guidance, changes to the criteria for the ``healthy'' claim are 
important to ensure that the claim is consistent with the longstanding 
purpose of this type of implied claim to indicate that the nutrient 
levels in a food may help consumers maintain healthy dietary practices 
(87 FR 59168 at 59172 through 59173). As explained throughout this 
section, such changes also advance FDA's goals of preventing misleading 
labeling and reducing consumer confusion potentially caused by the use 
of inconsistent definitions for nutrient content claims.
    Moreover, we disagree that the use of the ``healthy'' claim on non-
compliant products cannot be false or misleading because a large number 
of products that would be excluded from the proposed definition of 
``healthy'' are products that are currently promoted as healthy by the 
Dietary Guidelines. Dietary recommendations can change and evolve over 
time as scientific evidence develops, and therefore, a food that was 
recommended to be consumed as the foundation of a healthy dietary 
pattern years ago could no longer be considered a foundational food. We 
explain throughout this rule that the updated ``healthy'' criteria are 
consistent with the Dietary Guidelines recommendations to consume 
nutrient-dense foods (e.g., containing little or no added sugars, 
saturated fat, and sodium) and we provide examples of specific 
foundational foods promoted by the Dietary Guidelines that would 
qualify to bear the ``healthy'' claim based on the updated criteria 
(e.g., certain varieties of fruits and vegetables, whole grains, fat-
free and low-fat dairy, lean meat, eggs, beans, peas, lentils, nuts, 
seeds, water, etc.). However, where possible and consistent with 
current dietary recommendations, FDA has adjusted certain criteria to 
provide greater flexibility for foods to qualify to bear the 
``healthy'' claim in this final rule. Our response to comments raising 
similar concerns can be found in Response 155.
    (Comment 154) Several comments say that the proposed updated 
criteria for the ``healthy'' claim is a restriction on commercial 
speech and question whether it would satisfy the First Amendment test 
set forth in Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n, 447 
U.S. 557, 563-66 (1980). One comment asserts that FDA does not have a 
substantial government interest as required by Central Hudson because 
government lacks ``an interest in preventing the dissemination of 
truthful commercial information in order to prevent members of the 
public from making bad decisions with the information,'' citing 
Thompson v. W. States Med. Ctr., 535 U.S. 357, 374 (2002). Other 
comments argue that the proposed criteria for the ``healthy'' claim do 
not directly and materially advance FDA's substantial interest in 
reducing chronic disease. Some of these comments cite the proposed rule 
to support this assertion because its quantifiable benefits calculation 
estimated that ``a small number (0 to 0.4% of people that try to follow 
current dietary guidelines) of . . . consumers would use the `healthy' 
implied nutrient content claim to make meaningful, long-lasting food 
purchasing decisions'' (87 FR 59168 at 59168, 59195).
    (Response 154) As a preliminary matter, as discussed in Response 
153, the intention behind the statutory and regulatory requirements for 
nutrient content claims on food labels or labeling, including any 
``healthy'' claims, is to help ensure that consumers are adequately 
informed and not misled by such claims so that they can identify foods 
that may help them maintain healthy dietary practices. The use of the 
``healthy'' claim on products that do not meet the updated criteria for 
``healthy'' may be misleading for several reasons, including that such 
use may imply that the definition and regulatory requirements have been 
met when they have not. The use of ``healthy'' on food labels or 
labeling could be shown to be misleading for a myriad of other reasons 
based on the particular product and circumstances. Because, under the 
threshold step of the Central Hudson framework, the government can 
restrict speech that is false or inherently or actually misleading, at 
least some ``healthy'' claims would not be entitled to First Amendment 
protection because they are false or misleading.
    However, on a facial challenge, it may not be possible to 
categorically determine whether the universe of hypothetical claims is 
false or misleading. Under the Central Hudson framework, if commercial 
speech is truthful and is not inherently or actually misleading, the 
government must establish that the regulation directly advances a 
substantial government interest, and the regulation is no more 
extensive than necessary to serve that interest (Central Hudson, 447 
U.S. at 563-66). That means that government regulation of speech that 
is potentially misleading is subject to review under these remaining 
Central Hudson steps. See, e.g., Pearson v. Shalala, 164 F.3d 650, 655 
(D.C. Cir. 1999); Public Citizen, Inc. v. La. Atty. Disciplinary Bd., 
632 F.3d 212, 218 (5th Cir. 2011). Under the Central Hudson framework, 
``there is no question'' that the government's interest ``in ensuring 
the accuracy of commercial information in the marketplace is 
substantial,'' Edenfield v. Fane, 507 U.S. 761, 769 (1993), including 
``undoubtedly'' the ``[p]rotection of health and prevention of consumer 
fraud.'' Bellion Spirits, LLC v. United

[[Page 106149]]

States, 393 F. Supp. 3d 5, 24 (D.D.C. 2019), aff'd, 7 F.4th 1201 (D.C. 
Cir. 2021).
    Here, the substantial government interest is in providing 
information to consumers to indicate that the nutrient content of a 
food may help them maintain healthy dietary practices to promote public 
health, preventing misleading labeling, and reducing consumer confusion 
potentially caused by the use of inconsistent definitions for nutrient 
content claims. Courts have long recognized that the government has a 
significant interest in promoting or protecting public health by 
regulating the information in food labeling. See, e.g., Rubin v. Coors 
Brewing Co., 514 U.S. 476, 485 (1995); see also Am. Meat Inst. v. U.S. 
Dep't Agric., 760 F.3d 18 (D.C. Cir. 2014) (en banc) (finding 
individual health concerns related to food products to be one of 
several substantial government interests underlying USDA labeling 
disclosures); N.Y. State Rest. Ass'n v. N.Y. City Bd. of Health, 556 
F.3d 114, 134 (2d Cir. 2009) (recognizing ``informed consumer decision-
making so as to reduce obesity and the diseases associated with it'' 
through posting of calorie content information on menus as a 
substantial government interest); Bellion Spirits, LLC v. United 
States, 393 F. Supp. 3d at 25 (stating that the Alcohol and Tobacco Tax 
and Trade Bureau preventing a company from labeling and advertising its 
alcohol product to promote its biological benefits is directly 
connected to the substantial government interests of promoting health 
and preventing potential consumer deception). Moreover, we disagree 
that the Court's rationale in Western States is applicable to this 
rulemaking. In that case, the Court explained that, in general, the 
government should not restrict product advertising for the sole purpose 
of preventing members of the public from making bad decisions based on 
the advertising information. However, as described above, the interests 
here do not involve preventing members of the public from making bad 
decisions. To the contrary, the updated requirements to use the 
``healthy'' claim support consumer choice. The requirements advance 
government interests related to providing consumers with important 
product information at the point of sale so that they can identify 
foods that may help them maintain healthy dietary practices if they 
choose, and preventing misleading labeling and reducing consumer 
confusion potentially caused by the use of inconsistent definitions for 
nutrient content claims.
    The updated definition directly advances our substantial government 
interests in providing information to consumers to indicate that the 
nutrient content of a food may help them maintain healthy dietary 
practices to promote public health, preventing misleading labeling, and 
reducing consumer confusion potentially caused by the use of 
inconsistent definitions for nutrient content claims. Updating the 
``healthy'' definition to ensure that it is aligned with current 
nutrition science and Federal dietary guidance promotes public health 
by providing consumers with information about foods that, because of 
their nutrient content, are particularly useful in constructing a diet 
that is consistent with current dietary recommendations. Consumers may 
then use that information, at the point of decision-making, to identify 
foods that are foundational to a healthy diet. As explained in the 
preamble to the proposed rule, advancements in nutrition science have 
provided a greater understanding of, and focus on, the importance of 
healthy dietary patterns, and how dietary components may act 
synergistically to affect health. Other regulations, such as those 
updating the Nutrition Facts label and serving size information for 
packaged foods, have been updated to reflect new scientific 
information, including the Dietary Guidelines, 2015-2020, consensus 
reports, national survey intake data, and research regarding consumer 
use and understanding of the label. 87 FR 59172. Likewise, the updated 
criteria for the ``healthy'' claim, outlined in this rule, reflect the 
recommendations of the Dietary Guidelines, 2020-2025, which 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. Specifically, the updated ``healthy'' 
criteria include food group requirements instead of requirements for 
NTE (as in the original ``healthy'' definition) to reflect current 
nutrition science and Federal dietary guidance, including the Dietary 
Guidelines, 2020-2025, which describes a healthy dietary pattern as 
consisting of ``nutrient-dense forms of foods and beverages, across all 
food groups, in recommended amounts, and within calorie limits.'' As 
stated previously, the food group approach better accounts for how 
nutrients contribute to, and may work synergistically to create, a 
healthy dietary pattern and improve health outcomes (see sections V.C. 
``Food Group Equivalents'' and V.D.6 ``Nutrients to Encourage'' for 
further discussion about FGE requirements and NTE). Moreover, as 
explained further in other parts of this rule, the updated criteria 
also change the NTL requirements, for example, by incorporating limits 
on added sugars and removing limits on total fat and cholesterol. These 
changes reflect current nutrition science and the Dietary Guidelines, 
2020-2025, which now emphasize limiting added sugars intake and have 
moved away from recommending a specific intake for total fat. Rather, 
current dietary recommendations emphasize replacement of saturated fats 
in the diet with unsaturated fats, particularly polyunsaturated fats, 
and a dietary pattern that is low in saturated fat is typically low in 
dietary cholesterol (rendering a cholesterol limit unnecessary). (See 
section V.D.4 ``Added Sugars'' for further discussion of the added 
sugars limits and section V.D.5 ``Nutrients Not Included'' for further 
discussion of the elimination of total fat and dietary cholesterol 
limits in the updated ``healthy'' criteria).
    As demonstrated by these examples, and by others throughout the 
rule, this rule ensures that the criteria for ``healthy'' are 
harmonized with current regulations, nutrition science, and Federal 
dietary guidelines, and therefore that the ``healthy'' claim accurately 
indicates to consumers that a food, based on its nutrient levels, may 
help them maintain healthy dietary practices. Providing this 
information to consumers enables them to make more informed choices 
about the foods that can be the foundation of a healthy dietary 
pattern. It also comports with the legislative objectives of the NLEA 
to empower FDA to standardize nutrient content claims to ensure that 
they are accurate, not misleading, and can help consumers identify 
foods that can help them maintain healthy dietary practices.
    In addition, the updated definition prevents misleading labeling 
and reduces consumer confusion potentially caused by the use of 
inconsistent definitions for nutrient content claims by requiring that 
foods bearing the ``healthy'' claim meet standardized nutritional 
criteria that reflects current, up-to-date, nutrition science and 
dietary recommendations. As discussed in Response 153, the need for 
consistent labeling claims on foods to prevent the public from being 
misled was an explicit motivation of Congress when it passed the NLEA's 
nutrient content claim provisions. See, e.g., 136 Cong. Rec. H12954 
(October 26, 1990) (statement of Rep. Moakley) (``The

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current format for nutrition labeling on foods is often inadequate for 
today's consumer needs. In many cases the information is confusing and, 
in some cases, very misleading. Terms such as lite, high fiber, and low 
cholesterol, which now have little or no guidelines, will be defined 
and their use restricted to the FDA definition. This bill will help 
curb misleading claims . . .''). As such, the updated definition 
directly advances the goals of preventing misleading labeling and 
reducing consumer confusion potentially caused by the use of 
inconsistent definitions for nutrient content claims by ensuring that 
the term, ``healthy,'' when used in a nutritional context, has a 
consistent meaning that is supported by current nutrition science and 
Federal dietary guidance. Moreover, an updated, consistent definition 
for ``healthy'' enables consumers to identify foods that, based on 
current nutrition science and Federal dietary guidance, are 
particularly useful in building a healthy eating pattern, and to make 
more informed food selections and comparisons.
    We further disagree that the updated criteria for the ``healthy'' 
claim do not directly advance FDA's asserted government interests due 
to the quantifiable benefits calculation included in the proposed rule. 
This calculation considers numerous factors to estimate all of the 
potential benefits of the rule, such as a reduction in all-cause 
morbidity and mortality stemming from consumers selecting and consuming 
more healthful foods. However, as explained throughout this rule, the 
longstanding purpose of FDA's definition of the ``healthy'' nutrient 
content claim is to provide information to consumers that indicates 
that the nutrient levels of a food may help consumers maintain healthy 
dietary practices. Achieving specific changes in rates of chronic 
disease are not the government interests we assert, and the law 
therefore does not require that such changes be demonstrated.
    (Comment 155) One comment states that, while FDA does have a 
substantial interest in promoting public health through lawful 
restrictions on food labeling, the proposed added sugars and sodium 
limits for grain products would not directly advance that objective and 
would prohibit a broad range of nutrient-dense whole grain products 
from bearing ``healthy,'' which is in conflict with FDA's public health 
objectives and the Dietary Guidelines.
    (Response 155) We disagree that the added sugars and sodium limits, 
as applied to grain products, do not advance FDA's asserted interests, 
and that the sodium limit for grain products in this final rule would 
prohibit a broad range of nutrient-dense, whole grain products from 
bearing the ``healthy'' claim. The Dietary Guidelines, 2020-2025 
emphasizes that there is little room in most dietary patterns for 
excess sodium and state that shifts to more nutrient-dense forms of 
grains will help consumers to build healthy dietary patterns. Whole 
grain products that meet the established criteria for sodium are 
particularly useful, because of their nutrient content (including 
sodium amounts), in helping consumers identify foods that are the 
foundation of a healthy dietary pattern. As explained in section V.D.3 
(``Sodium''), the sodium limits for grain products are consistent with 
the Dietary Guidelines, 2020-2025, which recommends that consumers 
limit sodium in their diets as part of building healthy dietary 
patterns. Our marketplace review conducted in response to comments on 
this topic demonstrates that there are many whole grain products, 
including whole grain bread products (i.e., English muffin products and 
some whole grain tortillas) and cereals, that meet the <=10% DV limit 
for sodium.
    We note that after considering comments received, this final rule 
has increased the added sugars limit for whole grain products from <=5% 
DV to <=10% DV. FDA has determined that increasing the added sugars 
limit for whole grain products to <=10% DV aligns with the Dietary 
Guidelines, 2020-2025 by resulting in more whole grain cereal products, 
which can be important sources of nutrients based on their high 
likelihood of fortification, being able to qualify for the ``healthy'' 
claim. This increase is supported by our marketplace review that 
examined the added sugars content of whole grain products, including 
ready-to-eat cereals, hot cereals, and whole grain breads and crackers.
    In alignment with the Dietary Guidelines, 2020-2025 the framework 
of this rule emphasizes healthy dietary patterns and nutrient density 
by incorporating both FGE criteria and NTL criteria in the definition 
for the ``healthy'' claim. The FGE criteria combined with the added 
sugars and sodium limits ensure that grain products are nutrient-dense 
and contain levels of those nutrients that will help consumers identify 
foods that can be the foundation for a healthy dietary pattern, 
consistent with current nutrition science and Federal dietary guidance. 
Accordingly, such limits directly advance FDA's government interests in 
providing information to consumers that indicates that a food's 
nutrient content may help them maintain healthy dietary practices to 
promote public health, preventing misleading labeling, and reducing 
consumer confusion potentially caused by the use of inconsistent 
definitions for nutrient content claims.
    (Comment 156) Several comments state that the updated criteria are 
unduly restrictive and are therefore unconstitutional under Central 
Hudson. Some comments say that FDA is required to demonstrate that the 
updated criteria are the least restrictive means to achieve our goals, 
which the comments assert it cannot do. Other comments state that the 
criteria are more extensive than necessary to serve FDA's substantial 
government interest and are thus constitutionally impermissible under 
Central Hudson. One comment argues that FDA failed to consider less 
restrictive alternatives for the updated criteria because FDA could run 
a public education campaign to discourage consumers from eating food 
with added sugars or encourage them to eat foods that contain large 
servings from multiple food groups, which would lead consumers to eat 
food that FDA prefers. Some comments assert that FDA could engage in 
its own affirmative speech by running advertisements or distributing 
literature promoting its own vision of what constitutes a healthy diet 
and that Supreme Court precedent requires FDA to consider whether it 
can achieve its goals through its own informational efforts.
    (Response 156) We disagree that the rule is unduly restrictive. As 
an initial matter, more than one comment mischaracterizes the relevant 
inquiry under the Central Hudson standard, stating that the rule must 
be the least restrictive means to achieve the asserted government 
interest. The standard does not require the government to adopt the 
least restrictive means of advancing its goal (Bd. of Trustees of the 
State Univ. of New York v. Fox, 492 U.S. 469, 480 (1989)). Instead, the 
relevant inquiry is whether the fit between the government's ends and 
the means chosen to accomplish those ends ``is not necessarily perfect, 
but reasonable'' (Id.). Put another way, the question is not whether 
there is ``no conceivable alternative'' but instead whether the 
``regulation [does] not burden substantially more speech than is 
necessary to further the government's interests.'' Fleminger, Inc. v. 
U.S. Dep't of Health & Hum. Servs., 854 F. Supp. 2d 192, 196 (D. Conn. 
2012), citing Clear Channel Outdoor, Inc. v. City of New York, 594 F.3d 
94, 104 (2d Cir. 2010); Bd. of Trustees, 492 U.S. at 478.

[[Page 106151]]

    FDA's approach to updating the definition for ``healthy'' is no 
more extensive than necessary to serve our interests in providing 
information to consumers to indicate that a food's nutrient content may 
help them maintain healthy dietary practices to promote public health, 
preventing misleading labeling, and reducing consumer confusion 
potentially caused by the use of inconsistent nutrient content claims. 
The ``healthy'' nutrient content claim is voluntary. As we have 
discussed previously, nutrient content claims are not prohibited, but 
are permitted by statute and regulation under a range of circumstances. 
See section 403(r) of the FD&C Act and part 101, subpart D, ``Specific 
Requirements for Nutrient Content Claims.'' Nutrient content claim 
regulations prescribe that the information be presented in standardized 
form, using uniform terms defined by the Agency, so that consumers will 
not be misled (58 FR 2302 at 2394). Moreover, nutrient content claims 
are just one type of claim permitted on food labeling. As stated in 
multiple parts of this rule, there are many other avenues available for 
manufacturers to promote the benefits, including the nutrition- or 
health-related benefits, of their food products on their product labels 
or labeling. However, where the ``healthy'' claim is used in a 
nutritional context, and therefore suggests that a food, because of its 
nutrient content, may help consumers maintain healthy dietary 
practices, FDA's approach ensures that the foods meeting the criteria 
to bear the claim are those that can be consumed to help consumers in 
achieving a total diet that conforms to current dietary 
recommendations. This approach is a ``reasonable fit'' between FDA's 
ends and the means chosen to accomplish those ends (Fox, 492 U.S. at 
480).
    We carefully considered the requirements of the updated criteria to 
ensure they align with current nutrition science and Federal dietary 
guidance, including the Dietary Guidelines, 2020-2025, while providing 
flexibility where possible, based on relevant information such as 
current market conditions, consumer consumption patterns, consistent 
evidence of beneficial health effects, and our marketplace review. In 
certain instances, the rule sets forth exceptions from the updated 
criteria for certain foods that can contribute to a healthy dietary 
pattern without meeting the baseline FGE or NTL requirements. For 
example, after considering comments related to foods with small RACCs 
and their inability to meet FGE requirements, FDA determined that it is 
appropriate to apply the ``healthy'' criteria to individual foods with 
a RACC less than 50 g or less than 3 Tbsp on a per 50 g basis instead 
of a per RACC basis. This adjustment for small RACC foods is reflective 
of current nutrition science and Federal dietary guidance because there 
are many foods recognized by the Dietary Guidelines that are 
foundational to a healthy dietary pattern but that have RACCs that are 
smaller than the required FGE. As another example, the rule excludes 
the inherent saturated fat content in seafood and nuts, seeds, and 
soybeans, from the saturated fat limit because they have a fatty acid 
profile that is predominantly unsaturated fats, and scientific evidence 
demonstrates that there is a beneficial relationship between fatty 
acids contained in these foods and reduced risk of heart disease.
    Moreover, FDA carefully tailored the final rule by making 
adjustments across FGE and NTL criteria and food categories. Compared 
to the proposed rule, the final rule establishes more generous limits 
for FGEs for dairy products and for added sugars limits in a variety of 
food categories, such as grains, fruits and vegetables, protein foods, 
and mixed products and main dishes. Where no adjustments have been 
made, we determined, based on a number of factors, including practical 
considerations (e.g., current market conditions and the feasibility of 
food products in certain categories meeting the criteria, ability of 
consumers to choose from multiple options in such categories), that the 
foods that are eligible to bear the claim are those that are 
particularly useful in helping consumers to achieve a diet that 
conforms to current dietary recommendations.
    We disagree with the comments that suggest that informational 
efforts, such as a consumer education and outreach campaign, would be a 
sufficiently effective alternative to advancing the government 
interests. FDA recognizes the utility of consumer education and 
outreach campaigns and plans to educate consumers on the use of and 
updated definition for the ``healthy'' claim (see section V.L.4 
``Comments Regarding Consumer Education'' for further discussion of 
consumer education about the updated ``healthy'' definition). However, 
we disagree that a consumer education campaign of the type suggested by 
the comment would be an appropriate alternative to the rule.
    Even if a consumer education campaign, or other informational 
efforts led by FDA, including advertising and other literature, were 
appropriately designed to inform consumers about foods that are 
foundational to a healthy eating pattern, these efforts alone are not a 
practical or legitimate alternative to updating the criteria for the 
``healthy'' claim. However helpful such efforts may be in providing 
general information to consumers about building a healthy eating 
pattern, they are no substitute for the updated ``healthy'' 
requirements, which, consistent with Congressional intent, ensure that 
the ``healthy'' claim on a specific food product serves as a quick 
signal to consumers, at the point of decision-making, that the food is 
particularly useful in achieving a diet that is consistent with current 
dietary recommendations. This situation is thus very far from that 
considered in Nat'l Inst. of Family & Life Advocates v. Becerra 
(NIFLA), where the Court found it crucial that California was seeking 
to compel private clinics to provide notice that ``in no way relate[d] 
to the services th[e] licensed clinics provide'' but, instead, 
``require[d] these clinics to disclose information about state-
sponsored services.'' 585 U.S. 755, 769 (2018). The Court's conclusion 
that a State-sponsored public information campaign is appropriate and 
effective to inform the public about a State-sponsored service is 
unremarkable. In the context of a communication about a specific food 
product's nutritional content, however, informational efforts may not 
reach the same audience in the same timeframe as a ``healthy'' claim 
that is compliant with the updated criteria, and the generalized 
content of the informational campaign efforts would not be directly 
targeted to communication about a specific product. Here, in contrast 
to the situation in NIFLA, we are regulating claims a private party 
makes about the very product it is selling.
    Furthermore, these comments' suggestions would produce the result 
of FDA failing to update the original ``healthy'' definition, 
established in 1994, which is outdated and, in some ways, inconsistent 
with current nutrition science and Federal dietary guidance, while 
conducting consumer education and outreach to inform consumers about 
foods that, based on their nutrient levels, are particularly useful in 
constructing a diet that conforms to current dietary recommendations. 
Educational and outreach efforts of this nature are not a viable 
regulatory alternative because they could contradict the use of the 
existing ``healthy'' claim due to such claim's reliance on nutrition 
science and Federal dietary guidance from 1994. Accordingly, these 
efforts, by themselves, cannot ensure that the use

[[Page 106152]]

of the ``healthy'' claim on food packages is consistent with current 
nutrition science and Federal dietary guidance. Nor do they signal to 
the consumer, at the point of decision-making, that a specific food is 
particularly useful in helping them to build a diet that conforms to 
current dietary recommendations. As such, while we considered a variety 
of alternative approaches, we determined that they would be 
insufficiently effective in advancing FDA's interests in providing 
information to consumers to indicate that a food, because of its 
nutrient content, may help them maintain healthy dietary practices to 
promote public health, preventing misleading labeling, and reducing 
consumer confusion potentially caused by the use of inconsistent 
nutrient content claims.
    We note that FDA's nutrition labeling efforts, including this rule, 
are broadly intended to provide information to consumers about foods 
that can help them identify healthier choices and build a healthy 
eating pattern. Additionally, as explained further in section III. 
(``Background''), the rule does not represent an endorsement of certain 
foods by FDA and is not intended to discourage the consumption of 
certain foods as part of the total diet. To put it plainly, FDA does 
not have ``preferences'' about foods that consumers eat or do not eat, 
and therefore, any consumer education campaign pursued by FDA could not 
be designed to discourage or encourage consumption of foods consistent 
with such ``preferences.''
    (Comment 157) One comment asserts that the proposed definition of 
``healthy'' would burden ``far more speech than necessary'' because it 
prevents ``most objectively healthy foods,'' including those promoted 
by the Dietary Guidelines, from bearing the ``healthy'' claim. Some 
comments argue that a large percentage of foods on the official recipe 
website of the Dietary Guidelines would be unable to bear the 
``healthy'' claim. One comment further asserts that many nutrient-dense 
foods, including many whole grain breads, breakfast bars, yogurts, 
cereals, canned fruits, canned vegetables, and salad kits could not 
bear the claim, even though they are included in the current Dietary 
Guidelines.
    (Response 157) We disagree that the updated definition of 
``healthy'' is more restrictive than necessary to serve our interests 
because it excludes ``most objectively healthy foods,'' including those 
promoted by the Dietary Guidelines or included in the recipes on the 
Dietary Guidelines website. As discussed at length in different parts 
of this rule, foods that are eligible to bear the ``healthy'' claim are 
those that are particularly useful in constructing a diet that conforms 
to current dietary recommendations. Foods that do not qualify for 
``healthy'' are not necessarily ``unhealthy'' and may still be part of 
a healthy dietary pattern, and their nutritional attributes can be 
conveyed to consumers through other truthful and not misleading 
statements on the food label or in food labeling. Furthermore, many of 
the examples of foods included in the comment may qualify to bear the 
``healthy'' claim under the finalized criteria, depending on their 
specific nutrient profiles. As discussed in section V.D.3 (``Sodium''), 
our marketplace review found that many canned vegetables, including 
low-sodium canned vegetables and some reduced-sodium canned vegetables, 
do not exceed the finalized <=10% DV sodium limit. As discussed in the 
same section, many whole grain breads do not exceed the <=10% DV sodium 
limit, and we have provided additional flexibility for whole grain 
products, including whole grain breads, by increasing the added sugars 
limit from <=5% DV to <=10% DV for the grains group. Salad kits, or 
bagged salads with dressing or toppings, discussed in section V.D.4 
(``Added Sugars'') above, could be considered mixed products or main 
dishes, depending on their formulation, and the final rule increases 
the added sugars limits for mixed products, meals, and main dishes, to 
provide more flexibility for these types of nutrient-dense products 
while still aligning with current nutrition science and Federal dietary 
guidelines. Similarly, many of the recipes on the Dietary Guidelines' 
website are mixed products and main dishes rather than individual 
foods, and therefore, the foods in those recipes may be subject to the 
criteria for mixed products and main dishes, including the increased 
added sugars limits. We further note that, as explained in section 
V.D.6, while all of the MyPlate recipes contain nutrient-dense 
ingredients, some of the recipes are for foods, such as dessert foods, 
that are not the foundation of a healthy dietary pattern (e.g., recipes 
for apple crisps, chocolate squash cake, banana cupcakes, etc.). As 
such, not all foods for which recipes are included in the MyPlate 
website are particularly useful in achieving a healthy dietary pattern, 
and therefore, they may not qualify to bear the ``healthy'' claim.
    Additionally, as discussed in Response 155, the rule accounts for 
specific foods with a nutrient profile that may help consumers maintain 
healthy dietary practices but that may not meet certain generally 
applicable NTL or FGE requirements. If no exemption was established, we 
have determined that it is generally both practicable for foods to meet 
the updated criteria for the ``healthy'' claim and essential that they 
do so to ensure that the ``healthy'' claim provides a quick signal to 
consumers that foods bearing the claim are foundational to a healthy 
diet. As demonstrated by the examples above, FDA's approach to the 
updated criteria is narrowly tailored to serve our interests in 
providing information to consumers to indicate that a food's nutrient 
content may help them maintain healthy dietary practices to promote 
public health, preventing misleading labeling, and reducing consumer 
confusion potentially caused by the use of inconsistent nutrient 
content claims.
    (Comment 158) One comment states a belief that FDA is drawing the 
line in ``the most restrictive way possible'' and that the ``healthy'' 
criteria precludes foods from bearing ``healthy'' that align with the 
Dietary Guidelines. The comment suggests that FDA adopt its alternative 
approach to updating the ``healthy'' nutrient content claim, which 
includes a number of suggestions, such as maintaining NTE criteria as 
an alternative to FGE criteria (see Comment 3), incorporating a small 
RACC subcategory with modified criteria (see Comment 4), adopting a 
first ingredient approach (see Comment 7), aggregating food groups 
(Comment 101), and combining the individual and mixed food categories 
and increasing sodium, added sugars, and saturated fat limits in a 
stepwise manner based on RACC size (see Comment 65, Comments 70-72, 
Comment 102). Another comment says that the proposed limits for added 
sugars and sodium are ``far more restrictive than necessary'' because 
less restrictive limitations, such as the 20% DV limitations and 
alternative RACC Framework proposed by the comment, would allow FDA to 
better foster the consumption of whole grain products while controlling 
for added sugar and sodium consumption. The alternative RACC Framework 
would adopt higher nutrient limits for foods with RACCs above 30 g 
(e.g., a 20% DV limit for added sugars and sodium) and lower nutrient 
limits for foods with RACCs at or below 30 g (e.g., a 10% DV limit for 
added sugars and sodium).
    (Response 158) We disagree that the updated ``healthy'' criteria 
have been developed in the ``most restrictive way possible'' and that 
they preclude foods from being labeled as ``healthy'' that align with 
the Dietary Guidelines. Foods

[[Page 106153]]

that qualify to bear ``healthy'' based on the updated criteria are 
those foods that are particularly useful in helping consumers build a 
diet that conforms to current dietary recommendations. In other 
sections, we explain why we have or have not adopted the suggestions 
included in the commenter's proposed alternative approach to updating 
the ``healthy'' nutrient content claim (see Responses 7, 8, 11, 69, 74-
76, 105, and 106). Responses 155 and 156 provide further explanation of 
why the updated ``healthy'' criteria is narrowly tailored to serve our 
substantial government interests and information to support that such 
criteria are consistent with current nutrition science and Federal 
dietary guidance, including the Dietary Guidelines, 2020-2025.
    In regard to the alternative RACC framework and higher nutrient 
limits for sodium and added sugars, as discussed in section V.D.3 
(``Sodium''), we agree that there should be a stepwise approach across 
food categories (i.e., gradual increases in sodium or added sugars for 
individual foods with smaller RACCs, individual foods with larger 
RACCs, mixed products, main dishes, and meals), and we have modified 
the criteria by providing alternative criteria for foods with smaller 
RACCs. However, we disagree that a <=20% DV limit for sodium or added 
sugars for whole grain products is an appropriate less restrictive 
alternative to the finalized limits. As explained further above, a 20% 
DV for individual foods would be inconsistent with the Dietary 
Guidelines, 2020-2025, because it could result in the use of the claim 
on foods that contain more than limited amounts of sodium or added 
sugars. According to our regulations, products that contain 20% DV of 
sodium per serving are high in sodium or added sugars (Sec.  
101.54(b)), and therefore, a 20% DV limit for sodium or added sugars 
would run counter to the Dietary Guidelines recommendations for 
consumers to limit sodium and added sugars in their diets. However, as 
discussed in section V.D.4 (``Added Sugars''), we have increased the 
added sugars limit for whole grain products from <=5% DV to <=10% DV 
such that more nutrient-dense whole grain products, such as whole grain 
cereals, with limited amounts of added sugars to increase palatability, 
will qualify for the ``healthy'' claim.
    Accordingly, FDA has considered the suggestions included in the 
alternative approach, including a framework to adopt higher nutrient 
limits for foods with larger RACCs and lower nutrient limits for foods 
with smaller RACCs, and nutrient limits at 20% DV for sodium and added 
sugars for grain products, proposed by these comments, and either 
determined that the suggestions are appropriate to incorporate in the 
updated ``healthy'' criteria or that they would not be sufficiently 
effective in advancing FDA's stated interests in providing information 
to consumers to indicate that a food's nutrient content may help them 
maintain healthy dietary practices to promote public health, preventing 
misleading labeling, and reducing consumer confusion potentially caused 
by the use of inconsistent nutrient content claims.
    (Comment 159) One comment states that the rule is not narrowly 
tailored to its objective because it would exclude many foods that are 
nutrient-dense from qualifying to bear the ``healthy'' claim due to 
small differences between the criteria and the foods' food group 
amounts, added sugars content, and sodium content. It also states that 
in many instances, the rule would exclude products that might have 
otherwise met the ``healthy'' criteria, but that due to an added 
component, such as a sauce, may exceed the proposed nutrient limits, 
even though the sauce is the component that is likely to encourage 
consumers to eat the food. Another comment asks FDA to consider whether 
the nutrient limits in the rule are no more extensive than needed, 
particularly where a healthy dietary pattern could accommodate more 
flexibility in added sugars, sodium, and food groups than proposed, and 
where the rule would exclude foods encouraged as healthful by dietary 
guidance.
    (Response 159) We carefully considered comments that suggest lower 
FGE requirements and higher nutrient limits as part of the ``healthy'' 
criteria, and in some cases, have adopted more generous FGE 
requirements and nutrient limits where this will result in more 
nutrient-dense foods recommended by the Dietary Guidelines, 2020-2025 
being able to qualify for the ``healthy'' claim. In particular, to 
address concerns about the potential inability for nutrient-dense foods 
with limited amounts of added sugars to qualify for ``healthy,'' we 
increased the added sugars limit for individual fruits, vegetables, and 
protein foods, as well as mixed products, meals, and main dishes, to 
accommodate the purpose of added sugars in the formulation of these 
products, including texture, flavor standardization, and use of 
seasonings, sauces, and other ingredients in the formulation of 
recipes, while still aligning with current nutrition science and 
Federal dietary guidance. See section V.D.4 (``Added Sugars'') for 
further discussion of the added sugars limits for fruits, vegetables, 
and protein foods.
    Additional flexibility has been incorporated into other FGE 
requirements and nutrient limits, where aligned with the Dietary 
Guidelines recommendations and feasible and practical as demonstrated 
by our marketplace review. For example, we are finalizing a lower FGE 
requirement for dairy products at \2/3\ c-eq per RACC, as opposed to 
the proposed \3/4\ c-eq per RACC. We are increasing the added sugars 
limit for whole grain products from <=5% DV to <=10% DV and are 
excluding the inherent saturated fat in seafood and nuts, seeds, and 
soybeans from the saturated fat limits. We are further providing for 
automatic qualification, regardless of FGE or NTL criteria, for the 
following single-ingredient, nutrient-dense foods, with no other added 
ingredients except for water: vegetables, fruits, whole grains, fat-
free and low-fat dairy, lean game meat, seafood, eggs, beans, peas, 
lentils, nuts, and seeds, and for waters (carbonated or noncarbonated), 
coffee, and tea containing certain non-caloric ingredients such as 
flavors, low- or no-calorie sweeteners, vitamins, and minerals that 
contain less than 5 calories per RACC and per labeled serving. 
Consequently, the adjustments and exceptions from the FGE and NTL 
requirements are intended to strike a balance between alignment with 
the Dietary Guidelines recommendations to consume nutrient-dense foods 
with little or no added sugars, sodium, or saturated fat, and providing 
for practical flexibility for consumers and industry.
    We reiterate that all foods can be part of a healthy dietary 
pattern, but foods that qualify for the ``healthy'' claim are those 
foods that, based on current nutrition science and Federal dietary 
guidance, are particularly useful in constructing a diet that conforms 
to current dietary recommendations. Foods that do not qualify for the 
``healthy'' claim are not necessarily unhealthy and may have beneficial 
nutritional attributes that can be promoted through other truthful and 
not misleading statements on the food label or in food labeling.
    (Comment 160) Some comments assert that FDA failed to consider less 
restrictive alternatives for the added sugars requirements. One comment 
states that disclosure of the amount of added sugars in a food is 
already required on the Nutrition Facts label and FDA cannot explain 
why consumer cannot make decisions based on this data. The comment 
suggests that FDA could require foods with added sugars and bearing the 
``healthy'' claim to

[[Page 106154]]

include the added sugars in larger type or in a separate box. Other 
comments suggest that FDA could require foods containing certain 
amounts of added sugars and bearing the ``healthy'' claim to bear an 
additional disclosure contextualizing the use of the word ``healthy,'' 
such as ``see nutrition information for added sugars content.''
    (Response 160) We disagree that the added sugars declaration on the 
Nutrition Facts label or an alternative disclosure regarding added 
sugar content in addition to the ``healthy'' claim is a reasonable 
alternative to the added sugar limits in the definition of the 
``healthy'' claim. First, the added sugars declaration and the 
``healthy'' nutrient content claim convey distinct information on food 
labels and labeling. The added sugars declaration discloses the amount 
of added sugars in a food, while the ``healthy'' claim, when 
voluntarily used in a nutritional context, makes an implicit claim that 
the levels of nutrients in a food are such that the food is 
particularly useful in constructing a diet that conforms to current 
dietary recommendations. As explained in the proposed rule, 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. The original ``healthy'' criteria do 
not include limits for added sugars, which makes the criteria 
inconsistent with current nutrition science and Federal dietary 
guidance (87 FR 59168 at 59173). The updated ``healthy'' definition is 
intended to better represent the overall nutrient profile of foods and 
to identify foods that are nutrient dense--described in the Dietary 
Guidelines for Americans, 2020-2025, in part, as having little or no 
added sugars--and can be the foundation of a healthy dietary pattern. 
Therefore, updating the ``healthy'' criteria without imposing the added 
sugars limit, as suggested by these comments, would result in foods 
with added sugars over the recommended levels qualifying to bear the 
``healthy'' claim, which could thus provide inaccurate or misleading 
information to consumers about whether the food contains nutrient 
levels that may help them maintain healthy dietary practices. Such an 
approach would not be sufficiently effective in advancing FDA's 
asserted government interests.
    Second, requiring an additional disclosure of added sugar content 
on the label of products bearing the ``healthy'' claim or a statement 
to ``see nutrition information for added sugars content'' would be 
problematic under the same reasoning. Although such disclosures may 
provide or highlight information about a food's added sugars content, 
foods with excess added sugars could still qualify to bear the 
``healthy'' claim, and therefore, the claim would not help consumers 
identify foods that, based on their nutrient levels, are particularly 
useful in constructing a diet that conforms to current nutrition 
science and Federal dietary guidance. This result would undermine the 
purpose of the ``healthy'' claim.
    Moreover, even if a product bearing a ``healthy'' claim included an 
additional disclosure or disclaimer to ``contextualize the use of the 
word, `healthy,''' as suggested by the comment, or to explain that a 
food product bearing the ``healthy'' claim includes added sugars above 
the levels recommended by current nutrition science and Federal dietary 
guidance, such a statement would be contradictory to the ``healthy'' 
claim. Adding a disclaimer that does not serve to help consumer 
understanding, but merely contradicts the claim, is not a viable 
regulatory alternative. See, e.g., Resort Car Rental System, Inc. v. 
FTC, 518 F.2d 962, 964 (9th Cir. 1975) (per curiam) (upholding FTC 
order to excise ``Dollar a Day'' trade name as deceptive because ``by 
its nature [it] has a decisive connotation for which any qualifying 
language would result in contradiction in terms.''), cert denied, 423 
U.S. 827 (1975); Continental Wax Corp. v. FTC, 330 F.2d 475, 480 (2d 
Cir. 1964) (same); Pasadena Research Labs v. United States, 169 F.2d 
375 (9th Cir. 1948) (discussing ``self-contradictory labels''). In the 
FDA context, courts have repeatedly found such disclaimers ineffective 
see, e.g., United States v. Millpax, Inc., 313 F.2d 152, 154 & n.1 (7th 
Cir. 1963) (disclaimer stating that ``no claim is made that the product 
cures anything, either by the writer or the manufacturer'' was 
ineffective where testimonials in a magazine article promoted the 
product as a cancer cure); United States v. Kasz Enters., Inc., 855 F. 
Supp. 534, 543 (D.R.I. 1994) (``The intent and effect of the FDCA in 
protecting consumers from . . . claims that have not been supported by 
competent scientific proof cannot be circumvented by linguistic game-
playing.''), judgment amended on other grounds, 862 F. Supp. 717 
(1994). Here, because an added sugars-related disclaimer would be 
similarly ineffective, FDA reasonably chose to incorporate an added 
sugars limit into the updated criteria for the ``healthy'' claim.
4. Other Legal Issues
    (Comment 161) One comment suggests that FDA ensure that express 
preemption protection apply during the ``transition period'' between 
the publication of the final rule and the compliance date for the rule 
to prevent an influx of State lawsuits alleging that a failure to 
comply immediately with the new Federal requirements (before the 
Federal compliance date of such requirements) is actionable under State 
law. The comment noted that implied preemption was found by many courts 
during the designated Federal regulatory compliance period for other 
rules and specifically requested that FDA confirm that: (1) State law 
claims are preempted if they arise from labeling (on products 
manufactured, sold or distributed during the transition period) that 
complies with either the current version or the new version of the 
rule; and (2) failure to comply with the new rule is not a basis for 
determining that a product is not eligible for a ``healthy'' implied 
nutrient content claim until the final rule's compliance date. Other 
comments request that, should FDA give companies the choice of whether 
to comply with either the current version of the rule or the new 
version of the rule during the period between the publication of the 
final rule and the compliance date, FDA confirm that both versions of 
the rule would establish preemptive Federal ``requirements'' for the 
``healthy'' nutrient content claim within the meaning of section 343-1 
of the FD&C Act--such that section 343-1(a) of the FD&C Act expressly 
preempts State law requirements that differ from either version of the 
rule.
    (Response 161) As discussed in Section V.J (``Effective and 
Compliance Dates''), manufacturers would not be required to comply with 
requirements of the final rule until the compliance date. Thus, once 
any new requirements for the definition of the nutrient content claim 
``healthy'' are in effect, manufacturers could either comply with the 
new requirements or continue to use the original definition of 
``healthy'' until the compliance date.
    The express preemption provision in section 403A (21 U.S.C. 343-1) 
of the FD&C Act preempts State and local requirements specifically 
regarding food labeling claims. In FDA's view, the rule's compliance 
period does not create any exemption from the normal operation of 
preemption under section 403A of the FD&C Act or other applicable 
preemption principles. To the extent the theories raised in State

[[Page 106155]]

lawsuits regarding a failure to comply immediately with the new Federal 
requirements for the ``healthy'' claim depend on the contours of FD&C 
Act requirements, FDA does not intend to enforce against products that 
are in compliance with the original definition of ``healthy'' before 
the compliance date. We also highlight that section 745(a) of the 
Consolidated Appropriations Act, 2024 (Pub. L. 118-42), signed into law 
on March 9, 2024, states that manufacturers may continue to comply with 
requirements of the original definition of ``healthy'' until the 
compliance date of this final rule. Section 745(b) of the Consolidated 
Appropriations Act, 2024 states that any food manufactured and labeled 
as ``healthy'' before the compliance date of this final rule shall not 
be subject to state requirements for bearing the claim that are not 
identical to either: (1) FDA's original requirements in effect as of 
the date FDA published this final rule; or (2) FDA's updated 
``healthy'' requirements if State-law requirements go into effect 
before the compliance date of this final rule.
    (Comment 162) One comment asserts that the rule would result in a 
significant number of labeling and product formulation changes and that 
it would take longer to comply than the compliance period allows. The 
comment suggests that, instead of finalizing the rule, FDA should ``try 
out the new requirements on a small scale'' such as with only one food 
group initially, which would take ``into account the principles of 
avoidance of unnecessary barriers to trade and harmonization in the 
Agreement on Technical Barriers to Trade.'' Another comment raises the 
issue of U.S. products sold in other countries and suggests that 
companies, consumers, and investors are helped by alignment and 
transparency regarding the criteria and thresholds for front-of-pack 
labels and claims on food products.
    (Response 162) FDA has gone through an extensive and transparent 
rulemaking process to update the definition of the ``healthy'' claim 
and has established a 3-year compliance period. The comment failed to 
assert why additional time was needed beyond the 3 years provided in 
the proposed compliance date and made general, vague assertions about 
the difficulty of complying with the new definition. We address similar 
comments in section V.J (``Effective and Compliance Dates''). We do not 
agree that dividing the rule and only promulgating the new definition 
for one food group will serve the purpose of the definition of the 
claim and the comment did not provide any information about which food 
group it was proposing to begin the gradual change with, thus we have 
no basis on which to make such a decision to change the rule in this 
way. Further, we do not see how any unnecessary barriers to trade have 
been created with the updated rule, as the rule applies equally to 
foods manufactured in all parts of the world and sold in the United 
States and all food manufacturers have been provided 3 years to make 
any adjustments to their products. This is a voluntary claim, not a 
mandatory claim that would apply to all products. We note that our 
estimates (Ref. 39) indicate that only a small number of products will 
need to be relabeled or reformulated to comply with the new definition. 
Also, for products manufactured in the United States but sold abroad, 
we agree that alignment on labeling issues is helpful to the extent 
possible, but different countries have different legal structures and 
authorities under which to promulgate their labeling regulations, and 
that is no different for the area of claims than it is for any of our 
other labeling efforts. Whether there is a need for transparency 
regarding thresholds for various NTL as part of the healthy claim 
criteria is discussed in section V.K.2 (``Administrative Procedure 
Act'').

L. Miscellaneous Comments

1. Comments Regarding Infants and Children Under 2 Years of Age
    (Comment 163) Comments supporting our proposal state that it would 
not be appropriate to allow the ``healthy'' claim on products intended 
for infants and children under 2 years of age because they have very 
specific nutritional needs in this life stage. Some comments express 
concern that the ``healthy'' claim could be used to market products not 
recommended by nutrition experts for this age group (e.g., ``toddler 
milks'' that often contain added sugars). Another requests we limit use 
of the claim on products marketed to children in an age range that 
includes 2 years, such as 12-36 months.
    Other comments disagree with our proposal to exclude use of the 
claim on products intended for infants and children younger than 2 
years of age. Some comments suggest we use recommendations in the 
Dietary Guidelines, 2020-2025 or data from the Feeding Infants and 
Toddler Study to develop specific requirements or a framework for the 
use of the claim on foods intended for infants and children under the 
age of two. This could include modifying the ``healthy criteria'' to 
reflect the amount of food and number of eating occasions in this age 
group, adjusting FGEs to account for the dietary patterns of children 1 
to 2 and 2 to 3 years of age, and considering other age-appropriate 
nutritional considerations. Without doing so, a comment asserts that 
products intended for 2 to 3 year olds, such as pureed fruit and 
vegetable pouches, cannot meet the definition and other products 
recommended by the Dietary Guidelines, such as iron and zinc fortified 
infant cereal products, cannot bear the claim. The comment asserts that 
this could confuse parents if other fruit and vegetable products, such 
as canned or frozen varieties that may include added salt and sugar, 
are labeled ``healthy'' while baby food versions are not simply because 
they are marketed for infants. Additionally, some comments raise 
concern about unintended consequences given infants and children under 
two eat many of the same foods as older children and adults. For 
example, only skim milk bearing the ``healthy'' label when very young 
children require whole, full-fat milk for development or 100% fruit 
juice being labeled ``healthy,'' when it is not recommended for 
consumption in children under the age of 2. A comment also recommends 
that any ``healthy'' symbol clearly indicates age ranges.
    (Response 163) Infants and children under the age of 2 years have 
specific nutrient needs, consume small amounts more frequently than do 
older children and adults, and the types and amounts of foods that they 
can consume change rapidly, particularly in the first year of life. 
Proper nutrition is critically important for growth and brain 
development in this age group. As discussed in the proposed rule (87 FR 
59168 at 59181), 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 the ``healthy'' claim. Historically, 
the Dietary Guidelines have been directed to adults and children 2 
years of age and older. However, the Dietary Guidelines, 2020-2025 
highlights the importance of encouraging healthy dietary patterns at 
every life stage and includes new recommendations for healthy dietary 
patterns for infants and children younger than 2 years of age in this 
lifespan approach. The Dietary Guidelines, 2020-2025 also notes that 
this is a key time for establishing healthy dietary patterns that may 
influence the trajectory of eating behaviors and health throughout the 
course of life (Ref. 1).
    Infants and children younger than 2 years of age have specific 
nutritional

[[Page 106156]]

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 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 in the future. While the comments provided helpful data 
and information for consideration, at this time, given our limited 
resources and considering the importance of ensuring that any labeling 
provided for this vulnerable age group is sound, we are not extending 
use of the ``healthy'' claim to foods marketed for consumption by 
infants and children younger than 2 years of age. We need additional 
time to consider current nutrition recommendations for children under 2 
years of age as well as unique considerations for products intended for 
this age group as they relate to the ``healthy'' claim.
    With respect to the comments expressing concerns that parents may 
unknowingly feed a product with a ``healthy'' claim to an infant or 
child under the age of two where the product is not recommended for 
that age group, the ``healthy'' claim is but one piece of information 
on the label that can be used by consumers to identify foods that 
contribute to a healthy dietary pattern. It does not take the place of 
advice from a pediatrician, or other healthcare provider, nor should it 
signal that the product should be consumed by all individuals, 
regardless of their unique health considerations.
    As for the comments that express concern that products intended for 
children 2 through 3 years of age would not be eligible to bear the 
claim because the RACCs for those foods are smaller than the proposed 
FGEs, as discussed in Response 9, individual foods and mixed products 
comprised of one or more foods encouraged by the Dietary Guidelines 
with no added ingredients, except for water, automatically qualify to 
bear the claim. Therefore, products intended for children 2 to 3 years 
of age, such as fruit and vegetable puree pouches, with no other 
ingredients added other than water, would be eligible to bear the 
claim.
2. Comments Regarding Coordination With Other Nutrition Initiatives
    (Comment 164) Some comments recommend that the ``healthy'' 
definition and healthy symbol align and work together and that FDA 
share consumer research data they have collected so that companies can 
make the best use of the ``healthy'' claim and symbol. The comments 
encourage FDA to complete research and consumer testing on ``healthy'' 
symbols and state that the release of this final rule should include 
the symbol. Some comments request clarity regarding the regulatory 
relationship between the ``healthy'' definition and the development of 
front-of-package (FOP) labeling and request that research related to 
this endeavor be shared.
    (Response 164) The healthy symbol is intended to represent the 
nutrient content claim ``healthy.'' While these initiatives related to 
``healthy'' are related, they are on separate tracks, and therefore, we 
disagree the ``healthy'' claim final rule should include the symbol. 
FDA is continuing research into and consideration of the ``healthy'' 
symbol, and this work should not hold up the implementation of the 
``healthy'' final rule and its associated benefits given that the 
current definition is not consistent with current nutrition science and 
Federal dietary guidelines.
    FDA's work on front-of-package (FOP) nutrition labeling is a 
separate initiative and is intended to complement the Nutrition Facts 
label that is required on food packages by displaying simplified, at-a-
glance nutrition information that gives consumers additional context to 
help them quickly and easily make more informed food selections. We 
have announced our intent to publish a proposed rule on this topic. 
Additional information about our FOP research may be found on FDA's 
website (https://www.fda.gov/food/food-labeling-nutrition/front-package-nutrition-labeling) and will be shared as part of that 
rulemaking.
3. Comments Regarding Coordination With USDA
    (Comment 165) The comments express concerns that given that meat 
and poultry were not included as protein foods under FDA's proposed 
``healthy'' definition, and FSIS has not yet proposed a similar 
definition that looks at food groups such as meat and poultry, it is 
unclear how to assess FSIS-regulated products under FDA's proposed 
framework. The comments state that this makes it challenging for 
companies to assess the impact of the proposed rule across their entire 
product portfolios, particularly where the term ``healthy'' is used in 
a brand name across a portfolio, and to provide comments on how this 
framework would impact all foods. The comments explain that there is 
considerable uncertainty as to whether FSIS will update its ``healthy'' 
rule, whether there will be a significant delay in any such update, and 
whether FSIS will take a similar approach to that of FDA, for example, 
because FDA has not addressed meat and poultry products, it is not 
clear if a chicken noodle soup that contains \1/2\ FGE protein (i.e., 
chicken) and \1/2\ FGE vegetables (i.e., the food group requirements 
for a mixed product), and otherwise satisfies the NTL criteria, would 
qualify for the claim. The comments assert that this example 
underscores that close coordination between the Agencies responsible 
for the regulation of food labeling in the United States is needed for 
cohesive and consistent implementation of the rule and request that, 
before finalizing the rule, FDA seek input from FSIS on when FSIS plans 
to update its ``healthy'' definition and what approach will be used, to 
ensure that the approach specifically would work equally for FDA-
regulated and FSIS-regulated products.
    One comment encourages FDA to engage with FSIS to ensure that the 
FDA healthy criteria can be voluntarily applied to products under 
FSIS's authority if a food company wants to use the claim. The comments 
also ask FDA to encourage USDA to provide enforcement discretion for 
products that would qualify for the FDA's updated definition to bear a 
``healthy'' claim, assuming that meat or poultry would be considered 
part of the protein foods group, as is the case under the Dietary 
Guidelines. One comment notes the ambiguity in determination/
calculation of FGE of certain dairy foods such as yogurt and suggests 
that to remediate this problem, FDA should maintain and publish a 
compendium or database for manufacturers to use in calculating the 
amount of FGEs delivered by each food. The comment suggests this should 
be done in coordination with USDA--who maintains such information for 
the purpose of dietary monitoring programs via the FPED. One comment 
asserts that the changes in the rule would likely lead to change to the 
USDA meal patterns in the National School Lunch and School Breakfast 
Programs and stated that transition time for implementation to address 
such changes would be helpful.
    (Response 165) FDA consulted with USDA and other Federal Agencies 
to ensure we appropriately considered the

[[Page 106157]]

policies established by those Agencies when updating the ``healthy'' 
nutrient content claim. While we have different regulatory frameworks 
and authorities, FDA and USDA routinely collaborate on issues, 
including those related to food labeling and the healthy claim.
4. Comments Regarding Consumer Education
    (Comment 166) Some comments recommend, given that ``healthy'' is a 
voluntary nutrient content claim, that the use of the claim be 
accompanied by efforts that help consumers make informed food choices. 
The comments recommend that the ``healthy'' rule provide additional 
opportunities for meaningful nutrition education and improved consumer 
understanding of healthy dietary patterns, asserting that as proposed, 
the rule does not afford consumers any additional context on how the 
``healthfulness'' of a food is determined. One comment says FDA should 
allow for or require additional labeling to facilitate consumer 
education on the meaning of ``healthy'' when it is used as a nutrient 
content claim and state one such example could be the labeling scheme 
identified by USDA MyPlate, which requires the additional quantitative 
declaration of the amount of FGEs afforded by a food for consumer 
education (e.g., ``this product provides \3/4\ cup dairy equivalent. 
According to the DGA, 3 cup equivalents are recommended per day'') in 
order to use the MyPlate logo on foods. The comments claim that a 
greater public understanding of the criteria on which a ``healthy'' 
food is determined would further contribute to a reduction in chronic 
disease and support health equity, more specifically, consumers would 
have a basis for structuring all decisions in the context of their 
daily food group requirements. Some comments recommend that culturally 
appropriate resources on the food labeling update be disseminated to 
Native Americans, Alaskan Natives, and Native Hawaiian communities upon 
issuing the rule.
    (Response 166) We agree that consumer education about nutrition and 
healthy dietary practices would likely benefit a number of consumers in 
the United States and that consumer education will be an important tool 
for implementing the updated ``healthy'' claim and for maximizing the 
effectiveness of the ``healthy'' claim to help consumers identify foods 
that can be the foundation for a healthy dietary pattern. We are 
committed to helping increase understanding and use of the updated 
``healthy'' claim to improve healthy dietary patterns through consumer 
education, in collaboration with key Federal partners, as well as with 
industry partners. Broadly, aspects of those education and outreach 
activities may include how the presence of the claim is important to 
consider when constructing a healthy dietary pattern making clear that 
foods labeled as ``healthy'' are foundational foods in a healthy 
dietary pattern and that the claim does not imply that all other foods 
are considered unhealthy and the importance of choosing a variety of 
nutrient-dense foods and beverages across all food groups, in 
recommended amounts, while staying within calorie limits, to build a 
healthy dietary pattern consistent with the Dietary Guidelines.

VI. Economic Analysis of Impacts

A. Introduction
    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review 
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, 
Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4).
    Executive Orders 12866, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers 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). Rules are ``significant'' under Executive Order 12866, 
section 3(f)(1) (as amended by Executive Order 14094) if they ``have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator of the Office of Information and Regulatory 
Affairs (OIRA) for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities.'' OIRA has determined that this final rule is a 
significant regulatory action under Executive Order 12866, section 
3(f)(1).
    Because this rule is likely to result in an annual effect on the 
economy of $100 million or more or meets other criteria specified in 
the Congressional Review Act/Small Business Regulatory Enforcement 
Fairness Act, OIRA has determined that this rule falls within the scope 
of 5 U.S.C. 804(2).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because we estimate that the economic impact of this final 
rule will not exceed 3 percent of annual revenue, we certify that this 
rule will not 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 estimates of 
anticipated impacts, before issuing ``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 $183 
million, using the most current (2023) Implicit Price Deflator for the 
Gross Domestic Product. This final rule will result in an expenditure 
in any year that meets or exceeds this amount.

B. Overview of Benefits, Costs, and Transfers

    Some consumers use nutrient content claims such as ``healthy'' to 
inform their food purchases. Based on a 2019 meta-analysis on the 
effects of food labeling, we estimate that a small number of these 
consumers (0 to 0.4% of people that try to follow current dietary 
guidelines) would use the ``healthy'' implied nutrient content claim to 
make meaningful, long-lasting food purchasing decisions (Ref. 45). If 
the foods bearing the ``healthy'' claim more closely align with Federal 
dietary guidance, the claim can help consumers who are selecting those 
products in choosing a more healthful diet, which may result in lower 
chronic, diet-related diseases, including cardiovascular disease and 
type 2 diabetes. Quantifiable benefits of the final rule are the 
estimated reduction over time in all-cause mortality 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. The estimated benefits account for 
expected uncertainty and variability in consumer use of the ``healthy'' 
nutrient content claim and its long-term health impact. Discounted at 3 
percent over 20 years, the mean present value of benefits accrued to 
consumers using the ``healthy'' nutrient content claim is $686 million, 
with a lower bound estimate of $21 million and an upper bound estimate 
of $1.9 billion. Discounted at 7 percent over 20 years, the mean 
present value of benefits of the final rule is $438 million, with a 
lower bound estimate of

[[Page 106158]]

$14 million and an upper bound estimate of $1.2 billion.
    Quantified costs to manufacturers associated with updating the 
``healthy'' claim are labeling, reformulating, and recordkeeping. 
Overall, about 27,000 UPCs, or 10 percent of total UPCs, qualify for 
the original ``healthy'' implied nutrient content claim but only 5 
percent (12,500 UPCs) choose to label. The use of the ``healthy'' 
nutrient content claim is voluntary, but if the final 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'' 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 final rule's criteria have the 
option of labeling these products. In some cases, manufacturers may 
choose to reformulate a product so that it meets the final rule's 
criteria. Some recordkeeping is required for certain products using the 
``healthy'' claim and 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. The 
estimated costs account for expected uncertainty and variability in 
industry use of the ``healthy'' nutrient content claim and industry 
response to the final rule, including potential reformulation. 
Discounted at 3 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 $403 million, with a 
lower bound of $188 million and an upper bound of $737 million. 
Discounted at 7 percent over 20 years, the mean present value of costs 
of the proposed rule is $346 million, with a lower bound of $161 
million and an upper bound of $633 million.

[[Page 106159]]

[GRAPHIC] [TIFF OMITTED] TR27DE24.008

    We have developed an Economic Analysis of Impacts that assesses the 
impacts of the final rule. The full analysis of economic impacts is 
available in the docket for this final rule (Ref. 39) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

VII. 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.

VIII. Paperwork Reduction Act of 1995

    The final 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). The title, 
description, and respondent description of the information collection 
provisions are shown in the following paragraphs with an estimate of 
the annual recordkeeping and third-party disclosure burdens. 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.
    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. 
Respondents are from the private sector (for-profit businesses).
    Description: The final rule amends 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

[[Page 106160]]

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 final rule also requires 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 will need to 
remove the claim from its label, and a product that becomes eligible 
will be permitted to use the claim on its label.
    We estimate the recordkeeping burden of this collection of 
information as follows:
[GRAPHIC] [TIFF OMITTED] TR27DE24.009

    The final rule requires that each manufacturer of a food that bears 
the implied nutrient content claim ``healthy'' must create and maintain 
written records to verify that the food meets the FGE 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, 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% 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. 
These estimates are based on the analysis in Table 12 of the Final 
Regulatory Impact Analysis (FRIA) (Ref. 39). Table 12 of the FRIA 
estimates that 5,702 products will need recordkeeping, which equals 
about 1,900 products annually over a 3-year period (5,702 / 3). We 
estimate that each year approximately 1,900 manufacturers will each 
create and maintain 1 written record for a total of 1,900 records. We 
estimate that each record will require 15 to 30 minutes of 
recordkeeping for an annual recordkeeping burden of 950 hours (1,900 
records x 0.5 hour).
[GRAPHIC] [TIFF OMITTED] TR27DE24.010

    We assume there are two categories of UPCs that could require re-
labeling. First, if a UPC currently labeled ``healthy'' does not meet 
the required criteria, the manufacturer could choose to remove the 
``healthy'' claim or reformulate. In either case, the label would need 
to change, either to remove the ``healthy'' claim or to change the NFL 
after reformulation. Given the current UPCs labeled ``healthy'' that do 
not meet the required criteria, we estimate the number of UPCs that 
would remove the ``healthy'' claim or reformulate. Second, if a UPC not 
labeled ``healthy'' now meets the required criteria, the manufacturer 
could choose to add the ``healthy'' claim. Table 8 of the FRIA 
estimates the need for 21,328 total label changes, which would be about 
7,109 label changes annually over a 3-year period. 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. Each disclosure 
will take an estimated 1 hour to complete for an annual third-party 
disclosure burden of 7,109 hours.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

IX. Federalism

    We have analyzed this final 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,

[[Page 106161]]

that no State or political subdivision of a State may directly or 
indirectly establish under any authority or continue in effect as to 
any food in interstate commerce with respect to any requirement for 
nutrition labeling of food that is not identical to requirements 
established under section 403(r) of the FD&C Act.
    The express preemption provision of section 403A(a) of the FD&C Act 
does not preempt any State or local requirement respecting a statement 
in the labeling of food that provides for a warning concerning the 
safety of the food or component of the food (section 6(c)(2) of the 
Nutrition Labeling and Education Act of 1990, Public Law 101-535 
(1990)); however, it is possible that such a requirement could be 
preempted on another basis, such as under principles of implied 
preemption. This final rule creates requirements that fall within the 
scope of section 403A(a) of the FD&C Act.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects 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. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

XI. 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. Although FDA verified the website addresses 
in this document, please note that websites are subject to change over 
time.

    *1. USDA and HHS. Dietary Guidelines for Americans, 2020-2025. 
9th Edition. December 2020. Retrieved from: https://www.DietaryGuidelines.gov.
    *2. FDA. Human Foods Program. WenYen Juan, Ph.D., Nutritionist, 
Nutrition Assessment and Evaluation Branch, Division of Nutrition 
Labeling, Science and Claims, Office of Nutrition and Food Labeling. 
Memorandum to Administrative Record: ``Description of the Process To 
Review and Determine Which Foods in the Current Marketplace Meet the 
Updated Definition of Healthy.'' December 2024.
    *3. USDA, Agricultural Research Service, Food Surveys Research 
Group. Food Patterns Equivalents Database: Methodology and User 
Guide. Retrieved from: http://www.ars.usda.gov/nea/bhnrc/fsrg.
    *4. USDA and HHS. 2015-2020 Dietary Guidelines for Americans. 
8th Edition. December 2015. Retrieved from: https://www.DietaryGuidelines.gov.
    *5. FDA. ``Labeling of Plant-Based Milk Alternatives and 
Voluntary Nutrient Statements: Draft Guidance for Industry.'' 
February 2023. Retrieved from: https://www.fda.gov/media/165420/download?attachment.
    6. White House National Strategy on Hunger, Nutrition, and 
Health. Retrieved from: https://www.whitehouse.gov/wp-content/uploads/2022/09/White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf.
    *7. USDA: Agricultural Research Service: FoodData Central. 
Retrieved from: https://fdc.nal.usda.gov/index.html.
    *8. 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. USDA, Agricultural Research Service, Washington, 
DC. Retrieved from: https://www.dietaryguidelines.gov/2020-advisory-committee-report.
    9. 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.
    *10. National Academies of Sciences, Engineering, and Medicine 
2017. ``Guiding Principles for Developing Dietary Reference Intakes 
Based on Chronic Disease.'' Washington, DC: The National Academies 
Press. Retrieved from: https://doi.org/10.17226/24828.
    *11. National Academies of Sciences, Engineering, and Medicine 
2019. ``Dietary Reference Intakes for Sodium and Potassium.'' 
Washington, DC: The National Academies Press. Retrieved from: 
https://nap.nationalacademies.org/catalog/25353/dietary-reference-intakes-for-sodium-and-potassium.
    *12. FDA. ``Voluntary Sodium Reduction Goals: Target Mean and 
Upper Bound Concentrations for Sodium in Commercially Processed, 
Packaged, and Prepared Foods: Guidance for Industry.'' October 2021. 
Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-voluntary-sodium-reduction-goals.
    *13. FDA. ``Health Claim Notification for the Substitution of 
Saturated Fat in the Diet with Unsaturated Fatty Acids and Reduced 
Risk of Heart Disease.'' 2007. Retrieved from: https://www.fda.gov/food/food-labeling-nutrition/health-claim-notification-substitution-saturated-fat-diet-unsaturated-fatty-acids-and-reduced-risk.
    *14. FDA. ``The Use of an Alternate Name for Potassium Chloride 
in Food Labeling: Guidance for Industry.'' December 2020. Retrieved 
from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-alternate-name-potassium-chloride-food-labeling.
    *15. FDA. ``Use of Salt Substitutes To Reduce the Sodium Content 
in Standardized Foods: Proposed Rule.'' April 10, 2023. 88 FR 21148. 
Retrieved from: https://www.federalregister.gov/documents/2023/04/10/2023-06456/use-of-salt-substitutes-to-reduce-the-sodium-content-in-standardized-foods.
    16. Murphy M.M., C.G. Scrafford, L.M. Barraj, et al., 
``Potassium Chloride-Based Replacers: Modeling Effects on Sodium and 
Potassium Intakes of the U.S. Population with Cross-Sectional Data 
From NHANES 2015-2016 and 2009-2010,'' American Journal of Clinical 
Nutrition, 2021;114(1):220-30. doi: 10.1093/ajcn/nqab020.
    17. Antman E.M., L.J. Appel, D. Balentine, 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 June 24;129(25):e660-79. doi:10.1161/
CIR.0000000000000051.
    *18. 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.
    *19. USDA and HHS. ``Scientific Report of the 2015 Dietary 
Guidelines Advisory Committee,'' Advisory Report to the Secretary of 
Health and Human Services and the Secretary of Agriculture. 
Washington, DC, 2015. Retrieved from: http://health.gov/dietaryguidelines/2015-scientific-report/PDFs/Scientific-Report-of-the-2015-Dietary-Guidelines-Advisory-Committee.pdf.
    *20. USDA and HHS. ``Dietary Guidelines for Americans,'' Home 
and Gardening Bulletin No. 232, 1st Ed. Washington DC: U.S. 
Government Printing Office, 1980. Retrieved from: https://www.DietaryGuidelines.gov.
    *21. USDA and HHS. ``Dietary Guidelines for Americans,'' Home 
and Gardening Bulletin No. 232, 2nd Ed. Washington DC: U.S. 
Government Printing Office, 1985. Retrieved from: https://www.DietaryGuidelines.gov.
    *22. USDA and HHS. ``Nutrition and Your Health, Dietary 
Guidelines for Americans,'' Home and Gardening Bulletin No. 232, 3rd 
Ed. Washington DC: U.S. Government Printing Office, 1990. Retrieved 
from: https://www.DietaryGuidelines.gov.
    *23. USDA and HHS. ``Nutrition and Your Health, Dietary 
Guidelines for Americans,''

[[Page 106162]]

Home and Gardening Bulletin No. 232, 4th Ed. Washington DC: U.S. 
Government Printing Office, 1995. Retrieved from: https://www.DietaryGuidelines.gov.
    *24. USDA and HHS. ``Nutrition and Your Health, Dietary 
Guidelines for Americans,'' Home and Gardening Bulletin No., 232, 
5th Ed. Washington DC: U.S. Government Printing Office, 2000. 
Retrieved from: https://www.DietaryGuidelines.gov.
    *25. USDA and HHS. ``Nutrition and Your Health, Dietary 
Guidelines for Americans,'' Home and Gardening Bulletin No. 232, 6th 
ed. Washington DC: U.S. Government Printing Office, 2005. Retrieved 
from: https://www.DietaryGuidelines.gov.
    *26. USDA and HHS. ``Dietary Guidelines for Americans, 2010,'' 
7th Ed. Washington DC: U.S. Government Printing Office, 2010. 
Retrieved from: https://www.DietaryGuidelines.gov.
    *27. USDA. MyPlate Kitchen website. Retrieved from: https://www.myplate.gov/myplate-kitchen.
    *28. USDA. Food and Nutrition Service. Thrifty Food Plan, 2021. 
Retrieved from: https://www.fns.usda.gov/cnpp/usda-food-plans.
    29. Cifelli, C.J., S. Agarwal, and V.L. Fulgoni III. 
``Association of Yogurt Consumption with Nutrient Intakes, Nutrient 
Adequacy, and Diet Quality in American Children and Adults.'' 
Nutrients 2020, 12, 3435.
    *30. FDA. ``Nutrition and Supplement Facts Labels: Questions and 
Answers Related to the Compliance Date, Added Sugars, and 
Declaration of Quantitative Amounts of Vitamins and Minerals: 
Guidance for Industry.'' Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-nutrition-and-supplement-facts-labels-questions-and-answers-related-compliance.
    31. Baker-Smith C et al. (2019). ``The Use of Nonnutritive 
Sweeteners in Children.'' Pediatrics, 144(5), 1-18.
    32. Johnson R.K., A.H. Lichtenstein, C.A.M. Anderson, J.A. 
Carson, et al.; American Heart Association Nutrition Committee of 
the Council on Lifestyle and Cardiometabolic Health; Council on 
Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; 
Council on Quality of Care and Outcomes Research; and Stroke 
Council. ``Low-Calorie Sweetened Beverages and Cardiometabolic 
Health: A Science Advisory From the American Heart Association.'' 
Circulation. 2018 August 28;138(9):e126-e140. doi: 10.1161/
CIR.0000000000000569. PMID: 30354445.
    *33. FDA: FDA Evaluated Substances: Aspartame and Other 
Sweeteners in Food. Retrieved from: https://www.fda.gov/food/food-additives-petitions/aspartame-and-other-sweeteners-food.
    *34. WHO, Nutrition and Food Safety. April 12, 2022. ``Health 
Effects of the Use of Non-Sugar Sweeteners: A Systematic Review and 
Meta-Analysis.'' Retrieved from: https://www.who.int/publications/i/item/9789240046429.
    *35. FDA. ``Closer to Zero: Reducing Childhood Exposure to 
Contaminants From Food.'' Retrieved from: https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods.
    *36. USDA, Agricultural Research Service, Food Surveys Research 
Group. ``Continuing Survey of Food Intakes by Individuals 1989-91 
and Diet and Health Knowledge Survey 1989-91.'' Retrieved from: 
https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/csfii-1989-1991-and-dhks-1989-1991/.
    *37. Centers for Disease Control and Prevention. National Center 
for Health Statistics. ``National Health and Nutrition Examination 
Survey.'' 2015-2016. Retrieved from: https://wwwn.cdc.gov/nchs/nhanes/continuousnhanes/default.aspx?BeginYear=2015.
    *38. Centers for Disease Control and Prevention. National Center 
for Health Statistics. ``National Health and Nutrition Examination 
Survey.'' 2017-2020. Retrieved from: https://wwwn.cdc.gov/nchs/nhanes/continuousnhanes/default.aspx?Cycle=2017-2020.
    *39. FDA. Final Regulatory Impact Analysis. Retrieved from: 
https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.
    *40. USDA School Nutrition and Meal Cost Study. Retrieved from: 
https://www.fns.usda.gov/school-nutrition-and-meal-cost-study.
    *41. WHO Draft Guideline: Use of Non-Sugar Sweeteners. Retrieved 
from: https://extranet.who.int/dataformv3/upload/surveys/155928/files/NSS%20guideline_DRAFT_PC%20July%202022.pdf.
    *42. WHO Guideline: Use of Non-Sugar Sweeteners. Geneva: World 
Health Organization, 2023. Retrieved from: https://iris.who.int/bitstream/handle/10665/367660/9789240073616-eng.pdf?sequence=1.
    *43. FDA. ``Letter Responding to Health Claim Petition dated 
January 27, 2004: Green Tea and Reduced Risk of Cancer Health Claim 
(Docket number FDA-2004-Q-0427). Retrieved from: https://Labeling & 
Nutrition  Letter Responding to Health Claim Petition 
dated January 27, 2004: Green Tea and Reduced Risk of Cancer Health 
Claim (Docket number FDA-2004-Q-0427) (archive-it.org).
    44. Reedy, J., S.M. Krebs-Smith, P.E. Miller, et al., ``Higher 
Diet Quality Is Associated with Decreased Risk of All-Cause, 
Cardiovascular Disease, and Cancer Mortality Among Older Adults.'' 
The Journal of Nutrition, 144(6):881-889, 2014.
    45. Shangguan, S., A. Afshin, M. Shulkin, et al., ``A Meta-
Analysis of Food Labeling Effects on Consumer Diet Behaviors and 
Industry Practices.'' American Journal of Preventive Medicine, 
56(2):300-314, 2019.
    46. CDC. Food Service Guidelines Toolkit. Retrieved from: 
https://www.cdc.gov/food-service-guidelines-toolkit/php/strategize-act/cultural-food-preferences.html.
    47. FDA. ``Voluntary Sodium Reduction Goals: Target Mean and 
Upper Bound Concentrations for Sodium in Commercially Processed, 
Packaged, and Prepared Foods (Edition 2): Draft Guidance for 
Industry.'' August 2024. Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-voluntary-sodium-reduction-goals-edition-2.

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 and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended 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. In Sec.  101.13, revise paragraph (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. In Sec.  101.65, revise paragraphs (a)(2) and (d) to read as 
follows:


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

    (a) * * *
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  101.13, with the exception of 
Sec.  101.13(h) when the nutrient content claim is made in accordance 
with paragraph (d) of this section; and
* * * * *
    (d) General nutritional claims. (1) This paragraph 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'' 
identifies qualifying amounts of foods from each food group based on 
nutritional content. A food group equivalent is equal to the following:

[[Page 106163]]



                       Table 1 to Paragraph (d)(2)
------------------------------------------------------------------------
                                   Food group
         Food group                equivalent             Examples
------------------------------------------------------------------------
(i) Vegetable...............  1/2 cup equivalent    1/2 cup cooked green
                               vegetable.            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................  3/4 oz equivalent     1 slice of bread; \1/
                               whole grain.          2\ cup cooked brown
                                                     rice
(iv) Dairy..................  2/3 cup equivalent    2/3 cup fat free
                               dairy.                milk; 1 oz nonfat
                                                     cheese
(v) Protein foods...........  1 \1/2\ oz            1 \1/2\ oz venison
                               equivalent game
                               meat.
                              1 oz equivalent       1 oz tuna
                               seafood.
                              1 oz equivalent egg.  1 large egg
                              1 oz equivalent       1/4 cup black beans
                               beans, peas, or
                               lentils.
                              1 oz equivalent       1/2 oz walnuts
                               nuts, seeds, or soy
                               products.
------------------------------------------------------------------------

    (3) You may use the term ``healthy'' or derivative terms 
``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 the criteria of one or more of the 
following paragraphs (d)(3)(i) through (vi) of this section as follows:
    (i) An individual food or mixed product that is comprised of one or 
more of the following foods that are the foundation of a healthy 
dietary pattern, with no other added ingredients except for water:
    (A) Vegetable;
    (B) Fruit;
    (C) Whole grains;
    (D) Fat-free or low-fat dairy;
    (E) Lean meat, seafood, eggs, beans, peas, lentils, nuts, or seeds.
    (ii) Individual foods.
    (A) An individual food that has a reference amount customarily 
consumed (RACC) greater than 50 g or greater than 3 tablespoons and 
meets the conditions per RACC in table 2 of this section; or

                                                           Table 2 to Paragraph (d)(3)(ii)(A)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                    If the food is . . .
------------------------------------------------------------   It must contain at       The added sugars      The sodium content     The saturated fat
                                        Sub-category (if           least . . .         content must be no     must be no greater     content must be no
           Main category                   applicable)                                 greater than . . .         than . . .         greater than . . .
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) A vegetable product............  ......................  1/2 cup equivalent      2% DV................  10% DV...............  5% DV.
                                                              vegetable.
(2) A fruit product................  ......................  1/2 cup equivalent      2% DV................  10% DV...............  5% DV.
                                                              fruit.
(3) A grain product................  ......................  3/4 oz equivalent       10% DV...............  10% DV...............  5% DV.
                                                              whole grain.
(4) A dairy product................  ......................  2/3 cup equivalent      5% DV................  10% DV...............  10% DV.
                                                              dairy.
(5) Protein Foods..................  (i) Game meats........  1 \1/2\ oz equivalent.  2% DV................  10% DV...............  10% DV.
                                     (ii) Seafood..........  1 oz equivalent.......  2% DV................  10% DV...............  5% DV, excluding
                                                                                                                                    saturated fat
                                                                                                                                    inherent in seafood.
                                     (iii) Egg.............  1 oz equivalent.......  2% DV................  10% DV...............  10% DV.
                                     (iv) Beans, peas, and   1 oz equivalent.......  2% DV................  10% DV...............  5% DV.
                                      lentils.
                                     (v) Nuts, seeds, and    1 oz equivalent.......  2% DV................  10% DV...............  5% DV, excluding
                                      soy products.                                                                                 saturated fat
                                                                                                                                    inherent in nuts,
                                                                                                                                    seeds, and soybeans.
(6) Oils...........................  (i) 100% Oil..........  ......................  0% DV................  0% DV................  20% of total fat.
                                     (ii) Oil-based spreads  ......................  0% DV................  10% DV...............  20% of total fat.
                                      whose fats come
                                      solely from oil.
                                     (iii) Oil-based         ......................  2% DV................  10% DV...............  20% of total fat.
                                      dressing containing
                                      at least 30% oil and
                                      oils meet the
                                      requirements in
                                      paragraph
                                      (d)(3)(ii)(A) or
                                      (B)(6)(i) of this
                                      section.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (B) An individual food that has a RACC of 50 g or less or 3 
tablespoons or less and meets the conditions per 50 g of food in table 
3 of this section:

[[Page 106164]]



                                                           Table 3 to Paragraph (d)(3)(ii)(B)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                    If the food is . . .
------------------------------------------------------------   It must contain at       The added sugars      The sodium content     The saturated fat
                                        Sub-category (if           least . . .         content must be no     must be no greater     content must be no
           Main category                   applicable)                                 greater than . . .         than . . .         greater than . . .
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) A vegetable product............  ......................  1/2 cup equivalent      2% DV................  10% DV...............  5% DV.
                                                              vegetable.
(2) A fruit product................  ......................  1/2 cup equivalent      2% DV................  10% DV...............  5% DV.
                                                              fruit.
(3) A grain product................  ......................  3/4 oz equivalent       10% DV...............  10% DV...............  5% DV.
                                                              whole grain.
(4) A dairy product................  ......................  2/3 cup equivalent      5% DV................  10% DV...............  10% DV.
                                                              dairy.
(5) Protein Foods..................  (i) Game meats........  1 \1/2\ oz equivalent.  2% DV................  10% DV...............  10% DV.
                                     (ii) Seafood..........  1 oz equivalent.......  2% DV................  10% DV...............  5% DV, excluding
                                                                                                                                    saturated fat
                                                                                                                                    inherent in seafood.
                                     (iii) Egg.............  1 oz equivalent.......  2% DV................  10% DV...............  10% DV.
                                     (iv) Beans, peas, and   1 oz equivalent.......  2% DV................  10% DV...............  5% DV.
                                      lentils.
                                     (v) Nuts, seeds, and    1 oz equivalent.......  2% DV................  10% DV...............  5% DV, excluding
                                      soy products.                                                                                 saturated fat
                                                                                                                                    inherent in nuts,
                                                                                                                                    seeds, and soybeans.
(6) Oils...........................  (i) 100% Oil..........  ......................  0% DV................  0% DV................  20% of total fat.
                                     (ii) Oil-based spreads  ......................  0% DV................  10% DV...............  20% of total fat.
                                      whose fats come
                                      solely from oil.
                                     (iii) Oil-based         ......................  2% DV................  10% DV...............  20% of total fat.
                                      dressing containing
                                      at least 30% oil and
                                      oils meet the
                                      requirements in
                                      paragraph
                                      (d)(3)(ii)(A) or
                                      (B)(6)(i) of this
                                      section.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (iii) A mixed product that meets the following conditions per RACC:

                                        Table 4 to Paragraphs (d)(3)(iii)
----------------------------------------------------------------------------------------------------------------
                                                                                         Excluding saturated fat
                                                                                           inherent in seafood,
                                                                                             nuts, seeds, and
                                           The added sugars     The sodium content must      soybeans in soy
   If the mixed product contains at       content must be no     be no greater than . .        products (if
             least . . .                  greater than . . .               .                 applicable), the
                                                                                          saturated fat content
                                                                                         must be no greater than
                                                                                                  . . .
----------------------------------------------------------------------------------------------------------------
One total food group equivalent with   10% DV.................  15% DV.................  10% DV.
 no less than \1/4\ food group
 equivalent from at least two food
 groups, as specified in paragraph
 (d)(2) of this section.
----------------------------------------------------------------------------------------------------------------

    (iv) A main dish product as defined in Sec.  101.13(m) that meets 
the following conditions per labeled serving:

                                         Table 5 to Paragraph (d)(3)(iv)
----------------------------------------------------------------------------------------------------------------
                                                                                         Excluding the saturated
                                                                                             fat inherent in
                                                                                          seafood, nuts, seeds,
                                           The added sugars     The sodium content must    and soybeans in soy
 If the main dish product contains at     content must be no     be no greater than . .        products (if
             least . . .                  greater than . . .               .                 applicable), the
                                                                                          saturated fat content
                                                                                         must be no greater than
                                                                                                  . . .
----------------------------------------------------------------------------------------------------------------
Two total food group equivalents with  15% DV.................  20% DV.................  15% DV.
 no less than \1/2\ food group
 equivalent from at least two food
 groups, as specified in paragraph
 (d)(2) of this section.
----------------------------------------------------------------------------------------------------------------


[[Page 106165]]

    (v) A meal product as defined in Sec.  101.13(l) that meets the 
following conditions per labeled serving:

                                         Table 6 to Paragraph (d)(3)(v)
----------------------------------------------------------------------------------------------------------------
                                                                                         Excluding the saturated
                                                                                             fat inherent in
                                                                                          seafood, nuts, seeds,
                                           The added sugars     The sodium content must    and soybeans in soy
If the meal product contains at least     content must be no     be no greater than . .        products (if
                . . .                     greater than . . .               .                 applicable), the
                                                                                          saturated fat content
                                                                                         must be no greater than
                                                                                                  . . .
----------------------------------------------------------------------------------------------------------------
Three total food group equivalents     20% DV.................  30% DV.................  20% DV.
 with no less than \1/2\ food group
 equivalent from at least three food
 groups, as specified in paragraph
 (d)(2) of this section.
----------------------------------------------------------------------------------------------------------------

    (vi) All water, tea, and coffee with less than 5 calories per RACC 
and per labeled serving.
    (4) Each manufacturer of a food (other than 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, and 
foods described in paragraphs (d)(3)(i) and (vi) of this section) 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. 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 that must be kept in 
accordance with part 11 of this chapter. These records must be 
accurate, indelible, and legible.

    Dated: December 12, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-29957 Filed 12-19-24; 11:15 am]
BILLING CODE 4164-01-P`