106064 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Rules and Regulations 

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. 

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, PRAStaff@fda.hhs.gov. 

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-todate 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-ofgovernment 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 dietrelated 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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1The 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). 

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 shelfstable 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. 

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 (§ 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 (§ 101.65(d)(2)). 

Æ 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. 

Æ 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 (§ 101.65(d)(2)). 

• An FGE contains the following: 

(§ 101.65(d)(2)) 

Æ Vegetable—1/2 cup equivalent (c-eq) 

Æ Fruit—1/2 cup equivalent 

Æ Grains—3/4 ounce (oz) equivalent 

whole grain 

Æ Dairy—2/3 cup equivalent 

Æ Protein foods: 

■ Game meat—11⁄2 oz equivalent 

■ Seafood—1 oz equivalent 

■ Egg—1 oz equivalent 

■ Beans, peas, or lentils—1 oz 

equivalent 

■ 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: 

Æ 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: (§ 101.65(d)(3)(ii)(A) and 

(B)) 


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Æ A mixed product that meets the 

following conditions per RACC 

(§ 101.65(d)(3)(iii)): 


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Æ A main dish product as defined in 

§ 101.13(m) (21 CFR 101.13(m)) that 

meets the following conditions per 

labeled serving: (§ 101.65(d)(3)(iv)) 

Æ A meal product as defined in 

§ 101.13(l) that meets the following 

conditions per labeled serving: 

(§ 101.65(d)(3)(v)) 

• 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. 

§ 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. (§ 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. 

(§ 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 dietrelated 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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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 § 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 § 101.9 (21 

CFR 101.9) and serving size regulations 

at § 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 

(§ 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 nutrientdense foods, such as fruits, vegetables, 

and whole grains, as core elements of a 

healthy dietary pattern. ‘‘Nutrientdense’’ foods and beverages are defined 

as foods and beverages that provide 

vitamins, minerals, and other healthpromoting 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, nutrientdense 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 nutrientdense 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 

§ 101.62(c) (21 CFR 101.62(c))) or 

‘‘high’’ (§ 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/ 


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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 (§ 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 

(§ 101.65(d)(3)(i)). 

• The rule makes several changes to 

the FGE criteria from what we proposed, 

including: 

Æ The FGE for dairy is 2⁄3 c-eq instead 

of 3⁄4 c-eq. 

Æ 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) (§ 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 (§ 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. 


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Æ 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: 

Æ The rule provides more flexibility 

for sodium in mixed products by 

increasing the limit from ≤10% DV to 

≤15% DV per RACC (§ 101.65(d)(3)(iii)). 

Æ 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 (§ 101.65(d)(3)(ii)). 

Æ 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 

(§ 101.65(d)(3)(ii)). 

Æ 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 

(§ 101.65(d)(3)(ii)). This approach is 

consistent with the proposed approach 

for nut and seed products. 

Æ 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) 

(§ 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 (§ 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 


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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 (§ 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 § 101.65(d)(4). 

Failure to make and keep records and 

provide the records to FDA, as 

described in § 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. 


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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 


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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. 


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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 nutrientdense foods. The Dietary Guidelines, 

2020–2025 provides that a healthy 

dietary pattern consists of nutrientdense 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 ounceequivalents and recommended daily 

food group amounts developed for the 


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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 nutrientdense 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 (§ 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 (§ 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 (§ 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 (§ 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 

(§ 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 nutrientdense 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 


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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 (§ 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 shelfstable 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 singleingredient 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 

(§ 101.65(d)(3)(i)). We have determined 

that these types of products (i.e., mixed 

products that contain only nutrientdense 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 

§ 101.65(d)(3)(i). We are finalizing the 

expanded exemption under 

§ 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 § 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 § 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 entre ́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 

§ 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 

§ 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 entre ́e, vegetable side, 

and dessert. Because of their size and 

the larger contribution that they make to 

the overall diet, we are requiring in 

§ 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 singleingredient 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 


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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 nutrientdense 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 ounceequivalents 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 ounceequivalents 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 mealbased 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 ceq/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 


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(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 beverageonly 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 

§ 101.65(d)(3)(ii)(B) to provide methods 

for addressing the qualification of foods 

with small RACCs. We also revised the 

rule, at § 101.65(d)(i), to include a 

single-ingredient exemption, which 

expands the exemption for raw, whole 

fruits and vegetables to other nutrientdense 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 


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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, 

§ 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, 

§ 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 singleingredient 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 fibercontaining 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 ceq 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’’ 


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claim as individual vegetable foods, if 

they meet the applicable FGE and NTL 

criteria (see § 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, § 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 ounceequivalents 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 

§ 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 

(§ 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, 


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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 

(§ 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 

§ 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 ozeq 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 


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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 (§ 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 lowfat 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 ceq per RACC (see § 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 


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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 plantbased dairy alternatives must meet to 

qualify for the ‘‘healthy’’ claim. One 

comment asserts that if FDA permits 

nutritional comparisons between plantbased and traditional dairy products 

through the use of the term ‘‘healthy,’’ 

then FDA should require the plantbased products to bear the imitation 

labeling outlined in § 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 plantbased 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 


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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, soybased yogurt alternatives would need to 

have similar nutrient composition to 

traditional milk-based yogurt. Plantbased 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 plantbased milk alternatives (Ref. 5). 

Requiring plant-based products to bear 

imitation labeling as outlined in 

§ 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 ounceequivalent 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 ounceequivalents 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, plantbased 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 

(§ 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 51⁄2

oz-eq. For all the food groups, we 

calculated the FGE by dividing the daily 

amount by four eating occasions (51⁄2 oz 

equivalents of protein foods divided by 

four is 13⁄8 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 13⁄8 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 


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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 ceq 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 

§ 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 singleingredient foods in § 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. 


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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 healthrelated 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 oilbased 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 ultraprocessed 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, oilbased dressings, and oil-based spreads, 

provided they meet the specified 

criteria. We decline to lower the 

minimum amount of required oil in oilbased 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 ultraprocessed 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 


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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 beanbased 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 animalderived 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 


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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 § 101.13(q)(4)(ii). The 

comment also mentions that 

§ 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 


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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 

(§ 101.13(q)(4)(ii)). Our regulations also 

exempt certain label statements from 

FDA nutrient content claim 

requirements under § 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 

§ 101.13 (§ 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 § 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 nutrientdense 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 


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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 (§ 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 

(§ 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) 

(§ 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 nonnutrient 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 


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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 (§ 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 


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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 nutrientdense 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 nutrientdense 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 fullfat 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 plantbased 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 animalbased foods (e.g., dietary fiber); certain 

plant-based products, such as some soybased 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 animalbased foods having a higher saturated 

fat limit; and the reasons for the 

different saturated fat limits for animaland 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 soybased 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 § 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 FDAqualified 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 


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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 


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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., plantbased 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 


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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 § 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 

(§ 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 


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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 (§ 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 § 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 § 101.65(d)(3)(ii) 

for the seafood subgroup. 


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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 (§ 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 nutritionrelated 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 lowfat 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 fatfree 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 fatfree 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 fatfree 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 lowfat 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 


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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., fatfree 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., fatfree 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, oilbased 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 


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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 LDLcholesterol 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 oilbased 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, oilbased 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 


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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 singleingredient 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 singleingredient 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 nutrientdense 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 


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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 evidencebased 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 shortterm (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 


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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-saltadded, 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 

§ 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 


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limits may also result in industry 

innovation, which can increase the 

availability of lower sodium nutrientdense 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 nearterm, 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’’ 


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(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 twotiered 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-tofinal 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 plantbased 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 


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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) 

(§ 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 

§ 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) 

(§ 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 (§ 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 oilbased 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 


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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 nutrientdense 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 nutrientdense 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 nutrientdense 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 plantbased 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, 


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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 sodiumto-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 potassiumcontaining 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 (§ 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 


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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 


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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 

(§ 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 


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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 nutrientdensity’’ 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 ‘‘singleingredient 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 dairybased foods are ‘‘healthy’’ when 

containing ≤5% DV added sugars, but 

fruits, vegetables, and nut and seedbased 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 


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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 nutrientdense 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. Sugarsweetened 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 


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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 


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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 grainbased 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 readyto-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., grainbased 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 


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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 sugarsweetened 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 lowfat 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 lowfat 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 nutritionrelated 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 


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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 plantbased 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 plantbased 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 oilbased 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 nocalorie) sweeteners to be added sugars. 

Although we used the term ‘‘high 

intensity sweeteners’’ to describe 

sweeteners other than sugars and syrups 


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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 nocalorie sweeteners, including specific 

products such as aspartame, saccharin, 

sucralose, and acesulfame. They also 

question the validity of studies 

professing the safety of low- and nocalorie 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 nocalorie 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 lowand 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 nocalorie 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 lowor 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 


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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 nocalorie 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 Dtagatose 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 nocalorie 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. 


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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 monoand 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 § 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 LDLcholesterol 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 


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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 § 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 

(§ 101.13(h)). These nutrients are also 

included as NTL in the original 

definition of ‘‘healthy’’ (§ 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 cholesterolcontaining 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 

§ 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 


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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, nonnutrient-dense foods that have been 

fortified to meet the claim’s criteria. 

Many comments say the food groupbased 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 groupbased 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 


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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 nutrientdense 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 nutrientdense 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 nonmisleading 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 


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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 § 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 § 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 

§ 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; 


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• 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 

§ 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 

§ 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 

§ 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 § 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 


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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 

§ 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 

§ 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 § 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 § 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 § 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 § 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 

§ 101.65(d)(3)(iv)). For meal products, 

we are setting the limit at ≤20% of the 

DV per labeled serving (see 

§ 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 nutrientdense 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. 


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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 singleingredient exemption because both dry 

black beans and dry peas are singleingredient protein foods. Similarly, 

mixtures of solely one of the subgroup 

foods could fall under the singleingredient 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 singleingredient-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 (§ 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 

§ 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 


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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 singleingredient vegetable product) now 

qualifies for the ‘‘healthy’’ claim 

without needing to meet the FGE 

criteria or NTL criteria (see 

§ 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 ceq each of fruit or vegetable) (see 

§ 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 singleingredient 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 (§ 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 nutrientdense, 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 (§ 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 § 101.65(d)(3)(iv)). The 

requirements for the ‘‘healthy’’ claim do 

not conflict with the definitions of main 

dish and meal products in § 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 § 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 

§ 101.65(d)(3)(iv)–(vi)). Additionally, 

the saturated fat inherent in soybeans 

does not contribute to the saturated fat 

limit (see § 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 (§ 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 


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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 (§ 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 subcategory 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 caloriefree 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 


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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 


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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 nutritionrelated 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 noncaloric beverages provide are important 

considerations. According to the Dietary 

Guidelines, beverages that are caloriefree, 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 groupbased 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 nonnutritive or high-intensity sweeteners 

would be allowed). 

Some comments oppose the inclusion 

of beverages containing low- or nocalorie 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 lowand 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 singleingredient 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 

§ 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 

§ 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 

§ 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 

§ 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 singleingredient 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 § 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 


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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 § 101.65(d). Accordingly, 

the final rule, at § 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 § 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 

§ 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 § 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), 


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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 


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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 


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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 § 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 § 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 § 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, § 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 


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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-bycase 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-ofpack 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 


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product. The presence or absence of 

ingredients other than nutrients in a 

food product, as described in the 

comments (e.g., toxic elements and nonnutrient 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 

§ 101.65(d)(4). Failure to make and keep 

records and provide the records to FDA, 

as described in § 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. 


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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 (§ 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 § 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 


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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 § 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 

§ 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 


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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 ‘‘nutrientagnostic’’ 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,’’ 

(§ 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 

§ 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 


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‘‘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 § 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 


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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 healthrelated 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 decisionmaking 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 


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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. 


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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 singleingredient 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 


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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 


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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 nonmisleading 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 


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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 nutrientdense 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, fatfree 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, longlasting 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 


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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 allcause 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. 


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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 healthrelated 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 statesponsored 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 Statesponsored 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 


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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 lowsodium 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 nutrientdense 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 


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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 (§ 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 singleingredient, 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 nocalorie 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 


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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 gameplaying.’’), 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 


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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 


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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 frontof-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-labelingnutrition/front-package-nutritionlabeling) 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 FSISregulated 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 


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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 metaanalysis 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 allcause 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 


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$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. 


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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/regulatoryimpact-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 

§ 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 


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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: 

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 × 0.5 hour). 

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, 


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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/wpcontent/uploads/2022/09/White-HouseNational-Strategy-on-Hunger-Nutrition-andHealth-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-andpotassium. 

*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-guidancedocuments/guidance-industry-voluntarysodium-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-labelingnutrition/health-claim-notificationsubstitution-saturated-fat-diet-unsaturatedfatty-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-guidancedocuments/guidance-industry-use-alternatename-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-toreduce-the-sodium-content-in-standardizedfoods. 

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-DietaryGuidelines-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,’’ 


khammond on DSK9W7S144PROD with RULES3
106162 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Rules and Regulations 

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-foodplans. 

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/searchfda-guidance-documents/guidance-industrynutrition-and-supplement-facts-labelsquestions-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-andother-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-exposurecontaminants-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/beltsvillemd-bhnrc/beltsville-human-nutritionresearch-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-andmeal-cost-study. 

*41. WHO Draft Guideline: Use of NonSugar 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/foodservice-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/searchfda-guidance-documents/draft-guidanceindustry-voluntary-sodium-reduction-goalsedition-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 

■ 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. 

■ 2. In § 101.13, revise paragraph 

(b)(2)(ii) to read as follows: 

§ 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’’). 

* * * * * 

■ 3. In § 101.65, revise paragraphs (a)(2) 

and (d) to read as follows: 

§ 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 § 101.13, with 

the exception of § 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: 


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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Rules and Regulations 106163 

TABLE 1 TO PARAGRAPH (d)(2) 

Food group Food group equivalent Examples 

(i) Vegetable ......................................... 1/2 cup equivalent vegetable .................................. 1/2 cup cooked green beans; 1 cup raw spinach 

(ii) Fruit ................................................. 1/2 cup equivalent fruit ............................................ 1/2 cup strawberries; 1⁄2 cup 100% orange juice; 1⁄4 cup raisins 

(iii) Grains ............................................. 3/4 oz equivalent whole grain ................................. 1 slice of bread; 1⁄2 cup cooked brown rice 

(iv) Dairy ............................................... 2/3 cup equivalent dairy .......................................... 2/3 cup fat free milk; 1 oz nonfat cheese 

(v) Protein foods ................................... 11⁄2 oz equivalent game meat ................................. 11⁄2 oz venison 

1 oz equivalent seafood .......................................... 1 oz tuna 

1 oz equivalent egg ................................................. 1 large egg 

1 oz equivalent beans, peas, or lentils ................... 1/4 cup black beans 

1 oz equivalent nuts, seeds, or soy products ......... 1/2 oz walnuts 

(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 

least . . . 

The added sugars 

content must be no 

greater than . . . 

The sodium content 

must be no greater 

than . . . 

The saturated fat 

content must be no 

Main category greater than . . . Sub-category 

(if applicable) 

(1) A vegetable product............................... 1/2 cup equivalent 

vegetable.

2% DV ....................... 10% DV ..................... 5% DV. 

(2) A fruit product ....... .............................. 1/2 cup equivalent 

fruit.

2% DV ....................... 10% DV ..................... 5% DV. 

(3) A grain product ..... .............................. 3/4 oz equivalent 

whole grain.

10% DV ..................... 10% DV ..................... 5% DV. 

(4) A dairy product ..... .............................. 2/3 cup equivalent 

dairy.

5% DV ....................... 10% DV ..................... 10% DV. 

(5) Protein Foods ....... (i) Game meats ......... 11⁄2 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 

lentils.

1 oz equivalent ......... 2% DV ....................... 10% DV ..................... 5% DV. 

(v) Nuts, seeds, and 

soy products.

1 oz equivalent ......... 2% DV ....................... 10% DV ..................... 5% DV, excluding 

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 

whose fats come 

solely from oil.

.............................. 0% DV ....................... 10% DV ..................... 20% of total fat. 

(iii) Oil-based dressing containing at 

least 30% oil and 

oils meet the requirements in paragraph (d)(3)(ii)(A) 

or (B)(6)(i) of this 

section.

.............................. 2% DV ....................... 10% DV ..................... 20% of total fat. 

(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: 


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106164 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Rules and Regulations 

TABLE 3 TO PARAGRAPH (d)(3)(ii)(B) 

If the food is . . . 

It must contain at 

least . . . 

The added sugars 

content must be no 

greater than . . . 

The sodium content 

must be no greater 

than . . . 

The saturated fat 

content must be no 

Main category greater than . . . Sub-category 

(if applicable) 

(1) A vegetable product............................... 1/2 cup equivalent 

vegetable.

2% DV ....................... 10% DV ..................... 5% DV. 

(2) A fruit product ....... .............................. 1/2 cup equivalent 

fruit.

2% DV ....................... 10% DV ..................... 5% DV. 

(3) A grain product ..... .............................. 3/4 oz equivalent 

whole grain.

10% DV ..................... 10% DV ..................... 5% DV. 

(4) A dairy product ..... .............................. 2/3 cup equivalent 

dairy.

5% DV ....................... 10% DV ..................... 10% DV. 

(5) Protein Foods ....... (i) Game meats ......... 11⁄2 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 

lentils.

1 oz equivalent ......... 2% DV ....................... 10% DV ..................... 5% DV. 

(v) Nuts, seeds, and 

soy products.

1 oz equivalent ......... 2% DV ....................... 10% DV ..................... 5% DV, excluding 

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 

whose fats come 

solely from oil.

.............................. 0% DV ....................... 10% DV ..................... 20% of total fat. 

(iii) Oil-based dressing containing at 

least 30% oil and 

oils meet the requirements in paragraph (d)(3)(ii)(A) 

or (B)(6)(i) of this 

section.

.............................. 2% DV ....................... 10% DV ..................... 20% of total fat. 

(iii) A mixed product that meets the 

following conditions per RACC: 

TABLE 4 TO PARAGRAPHS (d)(3)(iii) 

If the mixed product contains at least . . . 

The added sugars 

content must be 

no greater than . . . 

The sodium content 

must be no 

greater than . . . 

Excluding saturated fat inherent in 

seafood, nuts, seeds, and soybeans 

in soy products (if applicable), 

the saturated fat content must be 

no greater than . . . 

One total food group equivalent with no less than 1⁄4

food group equivalent from at least two food 

groups, as specified in paragraph (d)(2) of this section.

10% DV ................... 15% DV ................... 10% DV. 

(iv) A main dish product as defined 

in § 101.13(m) that meets the following 

conditions per labeled serving: 

TABLE 5 TO PARAGRAPH (d)(3)(iv) 

If the main dish product contains at least . . . 

The added sugars 

content must be no 

greater than . . . 

The sodium content 

must be no 

greater than . . . 

Excluding the saturated fat inherent in 

seafood, nuts, seeds, and soybeans 

in soy products (if applicable), 

the saturated fat content must be 

no greater than . . . 

Two total food group equivalents with no less than 1⁄2

food group equivalent from at least two food 

groups, as specified in paragraph (d)(2) of this section.

15% DV ................... 20% DV ................... 15% DV. 


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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Rules and Regulations 106165 

(v) A meal product as defined in 

§ 101.13(l) that meets the following 

conditions per labeled serving: 

TABLE 6 TO PARAGRAPH (d)(3)(v) 

If the meal product contains at least . . . 

The added sugars 

content must be no 

greater than . . . 

The sodium content 

must be no 

greater than . . . 

Excluding the saturated fat inherent in 

seafood, nuts, seeds, and soybeans 

in soy products (if applicable), 

the saturated fat content must be 

no greater than . . . 

Three total food group equivalents with no less than 1⁄2 food group equivalent from at least three food 

groups, as specified in paragraph (d)(2) of this section.

20% DV ................... 30% DV ................... 20% DV. 

(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 


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