Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”

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-to-date information on food labels. This final rule is also consistent with the longstanding purpose of this implied nutrient content claim to indicate that the nutrient levels of a food may help consumers maintain healthy dietary practices and furthers FDA's goals in accordance with its statutory mandate to prevent misleading labeling and reduce consumer confusion that can result from the use of inconsistent definitions for nutrient content claims.

In addition, updating the “healthy” nutrient content claim is one initiative action listed in the White House National Strategy on Hunger, Nutrition, and Health under the pillar of empowering all consumers to make and have access to healthy choices (Ref. 6). FDA, as part of this whole-of-government approach, broadly seeks to help reduce the burden of diet-related chronic diseases. Doing so will advance health equity, because diet-related chronic diseases are experienced disproportionately by certain racial and ethnic minority groups and those with lower socioeconomic status. For further discussion regarding the scope of the problem Americans face from diet-related chronic diseases, please see the proposed rule, 87 FR 59168 at 59170. We are committed to accomplishing these goals, in part, by prioritizing nutrition initiatives that can help improve dietary patterns in the United States. An important aspect of reducing the burden of diet-related chronic diseases, as well as advancing health equity, is helping consumers access nutrition information that allows them to identify healthier choices. As discussed further in section V. (“Comments on the Proposed Rule and FDA Response”), nutrient content claims, such as “healthy,” as well as other claims made on labels or in the labeling of foods act as quick signals on food packages. These statements may help consumers, particularly those with lower nutrition or health literacy, quickly and easily identify foods that can be the foundation of a healthy dietary pattern. Additionally, as discussed further in section V. (“Comments on the Proposed Rule and

FDA Response”), our review of the products available in the current marketplace demonstrates that the updated “healthy” criteria allow affordable, accessible, and culturally preferred

1

nutrient-dense foods within different food groups and subgroups to bear the “healthy” claim, including frozen, canned, dried, and other shelf-stable products. This final rule is one part of FDA's broader commitment to help reduce diet-related chronic diseases and also to advance health equity by helping consumers to identify foods that can be the foundation of a healthy dietary pattern. While there has been consistency in many of the recommendations in Federal dietary guidelines and the underlying nutrition science on which they are based, we intend to remain aligned with the most current nutrition science reflected in Federal dietary guidelines and will continue to update our regulations and policies, as appropriate.

1

The term “culturally preferred foods” is used here to describe safe and nutritious foods that meet the diverse tastes and needs of customers based on their cultural identity (Ref. 46).

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)).

○ 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.

○ 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))

○ Vegetable—1/2 cup equivalent (c-eq)

○ Fruit—1/2 cup equivalent

○ Grains—3/4 ounce (oz) equivalent whole grain

○ Dairy—2/3 cup equivalent

○ Protein foods:

▪ Game meat—1

1/2

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:

○ 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))

ER27DE24.002

○ A mixed product that meets the following conditions per RACC (§ 101.65(d)(3)(iii)):

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○ 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))

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○ A meal product as defined in § 101.13(l) that meets the following conditions per labeled serving: (§ 101.65(d)(3)(v))

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• 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 diet-related chronic diseases, including cardiovascular disease (CVD) and type 2 diabetes. Quantifiable benefits of the rule are the estimated reduction over time in all-cause mortality stemming

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 nutrient-dense foods, such as fruits, vegetables, and whole grains, as core elements of a healthy dietary pattern. “Nutrient-dense” foods and beverages are defined as foods and beverages that provide vitamins, minerals, and other health-promoting components and have little or no added sugars, saturated fat, and sodium (Ref. 1). These foods, which contain a variety of important nutrients, work synergistically as part of a dietary pattern to help improve health (Ref. 1). A number of these nutrient-dense foods were not able to bear the “healthy” claim under the 1994 rule (

e.g.,

salmon due to fat amounts). Further, the 1994 rule permitted manufacturers to use the claim “healthy” on some foods that, based on updated nutrition science and Federal dietary guidance, contain levels of nutrients that would not help consumers maintain healthy dietary practices (

e.g.,

certain foods that are high in added sugars). We have long recognized the need to update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and Federal dietary guidance. Consequently, in the

Federal Register

of September 29, 2022 (87 FR 59168), we issued a proposed rule to amend the definition of “healthy” to ensure that foods bearing the claim are foods that may help consumers maintain healthy dietary practices, consistent with current nutrition science and Federal dietary guidance; in other words, nutrient-dense foods that are foundational to a healthy dietary pattern. The preamble to the proposed rule discussed, in some detail, the reasons why we felt it necessary to update the definition of “healthy” as an implied nutrient content claim (see 87 FR 59168 at 59169 through 59173).

When FDA first defined healthy in 1994 (59 FR 24232), we concluded that “the fundamental purpose of a `healthy' claim is to highlight those foods that, based on their nutrient levels, are particularly useful in constructing a diet that conforms to current dietary guidelines” (59 FR 24232 at 24233). Under this framework, which is continued under this rule, foods that do not qualify for use of the claim are not deemed to be “unhealthy” or unable to provide any nutritional benefits to consumers. Nor does the healthy definition, as established in this rule, represent a determination by FDA that consumers should only choose foods that qualify for the “healthy” claim or completely avoid choosing foods that do not qualify for the “healthy” claim. The current

Dietary Guidelines, 2020-2025

(Ref. 1) focuses on the importance of a healthy dietary pattern as a whole and its role in promoting health, reducing risk of chronic diseases, and meeting nutrient needs. Although nearly all foods can be incorporated into a healthy dietary pattern to some extent, current nutrition science emphasizes nutrient-dense foods, such as fruits, vegetables, and whole grains, as core elements of a healthy dietary pattern (Ref. 1). Moreover, foods that meet the requirements for “healthy” as defined in this rule are foods that, because of their overall nutrition profiles, can be the “foundation” or “building blocks” of a healthy dietary pattern recommended by the Dietary Guidelines.

Foods that do not meet the requirements defined in this rule to bear the “healthy” claim could, however, have beneficial nutritional attributes and these nutritional attributes can be communicated to consumers in many different ways. For example, use of other nutrient content claims, such as “low” (

e.g.,

“low saturated fat” in § 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/

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:

○ The FGE for dairy is

2/3

c-eq instead of

3/4

c-eq.

○ 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.

○ 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:

○ 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)).

○ 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)).

○ 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)).

○ 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.

○ 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

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.

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

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.

C. Food Group Equivalents

1. General Comments

(Comment 6) Numerous comments support using food groups as criteria in the definition of the claim “healthy,” stating that the change from focusing on individual nutrients better reflects the Dietary Guidelines, ensures that more nutrient-dense foods are included in the “healthy” definition, increases flexibility for certain products, avoids shifting nutrient guidelines, and is clearer to consumers. The comments mention that use of the food group criteria will enhance the messaging around the importance of creating healthy eating habits as opposed to a framework that targets individual foods. Some comments also provide that basing the “healthy” definition on food groups rather than individual nutrients is more consistent with evolving nutrition science that emphasizes dietary patterns. One comment mentions that requiring products to meet food-based criteria may help minimize or avoid unintended consequences of a focus solely on individual nutrients.

Some comments oppose use of food groups as criteria in the definition of the claim “healthy,” as opposed to individual nutrients, claiming the FGEs are too complex and difficult to calculate, that there is too much variance in nutrients within certain food groups, and the healthfulness of foods should be based on different individual nutrients. One comment claims that FDA has not adequately justified the move from only considering nutrients to also including food groups in the definition of the “healthy” claim.

(Response 6) We agree that the food group approach is in alignment with the

Dietary Guidelines, 2020-2025,

which places an emphasis on a healthy dietary pattern as a whole, rather than on individual nutrients or foods in isolation. The

Dietary Guidelines, 2020-2025

states that because foods provide an array of nutrients and other components that have health benefits, nutritional needs should be met primarily through a variety of nutrient-dense foods. The

Dietary Guidelines, 2020-2025

provides that a healthy dietary pattern consists of nutrient-dense forms of foods and beverages, in recommended amounts, across all food groups and recommends increasing intakes of certain food groups and subgroups to move intakes of underconsumed dietary components closer to recommendations.

We disagree that the FGE approach is too complex and note that there are several currently available resources that can help with calculation. As discussed further herein, the food groups and the FGE amounts are based on information contained in the

Dietary Guidelines, 2020-2025;

as such, the

Dietary Guidelines, 2020-2025

is a helpful resource in determining the amounts of foods necessary to meet FGEs. The USDA Food Patterns Equivalents Database (FPED) also provides information about cup- and ounce-equivalents of different foods and beverages to assist with calculations (Ref. 3). Additionally, FDA recognizes the importance of time for industry to determine the FGE amounts in their products, and we have set the rule's compliance date as being 3 years from the rule's effective date. We intend to provide additional resources for manufacturers to help determine FGE amounts before the compliance date. The additional resources may include guidance documents for industry, information on the FDA website, FAQs, direct communications in response to questions, or online webinars.

(Comment 7) Many comments support using food groups as criteria in the definition of the claim “healthy,” but ask that the rule maintain a level of reliance on individual beneficial nutrients or include requirements for beneficial nutrients as an alternative to ensure that important nutrients are not missed by the rule focusing too heavily on food groups. Some comments support the food group approach, but request that the updated “healthy” criteria permit a food to qualify if it meets both the NTL and either the food groups to encourage or the original NTE criteria.

(Response 7) We discussed in section III. (“Background”) that the purpose of a “healthy” claim is to highlight those foods that, based on their nutrient levels, are particularly useful in creating a diet that is consistent with current dietary guidelines. The current

Dietary Guidelines, 2020-2025

(Ref. 1) focuses on the importance of a healthy dietary pattern as a whole and its role in promoting health, reducing risk of chronic diseases, and meeting nutrient needs. Therefore, based on current dietary recommendations and nutrition science, foods that qualify for “healthy” are those foods that are particularly useful in helping consumers create healthy dietary patterns. As described by the

Dietary Guidelines, 2020-2025,

a healthy dietary pattern “consists of nutrient-dense forms of foods and beverages across all food groups, in recommended amounts, and within calorie limits.” The

Dietary Guidelines, 2020-2025

also describes that “[c]ommon characteristics of dietary patterns associated with positive health outcomes include relatively higher intake of vegetables, fruits, legumes, whole grains, low- or non-fat dairy, lean meats and poultry, seafood, nuts, and unsaturated vegetable oils, and relatively lower consumption of red and processed meats, sugar-sweetened foods and beverages, and refined grains.” (Ref. 1). The original definition for the “healthy” nutrient content claim was based solely on individual nutrients, both minimum amounts and specific limits. This approach is inconsistent with current nutrition science regarding healthy dietary patterns and their effect on health and development of chronic disease. Foods that contain certain NTE, such as certain individual vitamins, minerals, or fiber, can be beneficial to consumers. However, highlighting those foods as “healthy” would not necessarily help consumers in the overall construction of healthy dietary patterns, in which nutrient-dense foods from across all of the recommended food groups and subgroups provide an array of nutrients and ensure overall nutrient adequacy from the diet. Including requirements for minimum amounts of foods from the recommended food groups better reflects the overall nutrient content of foods and how nutrients in the food groups and subgroups may work together as part of a healthy dietary pattern. Thus, we decline to include individual NTE criteria in the final rule.

(Comment 8) Some comments assert that FDA's proposed FGE is sometimes larger than the serving size of the product itself, particularly for products with small serving sizes that would be unable to qualify as “healthy” because they could not provide an FGE per RACC. Examples of types of foods discussed in the comments include certain whole grain bread products, certain snack foods, natural cheeses, and many yogurts. The comments state that these smaller RACC products would be excluded from making “healthy” claims solely based on their serving size. The comments request that FDA modify the criteria for products with small RACCs to require a smaller contribution to the FGEs. The comments suggest various different modifications to the criteria, including lowering the required FGE amounts, adjusting the criteria for the claim to incrementally increase based on food size, and adopting a category with criteria for foods with small RACCs.

(Response 8) In the proposed rule (87 FR 59168 at 59177), we determined the FGEs based on the cup- and ounce-equivalents and recommended daily food group amounts developed for the

Healthy U.S.-Style Dietary Pattern for ages 2 and older in the

Dietary Guidelines, 2020-2025

(Ref. 1). The proposed thresholds for the FGEs were set so that foods that bear the claim “healthy” contain enough of the food group that they could help consumers achieve the recommended daily food group amounts. Foods that do not contain the minimum FGE amount for their food group would not meet the requirements and not be eligible to bear the claim. As many comments point out, however, there are many foods that are included in the food groups recommended by the Dietary Guidelines, and fit into healthful dietary patterns, that are in forms whose RACCs are smaller than the minimum FGE requirement. After evaluating nutrient-dense foods with small RACCs across the recommended food groups and subgroups, we have determined that many of these foods with RACCs smaller than the proposed FGEs could qualify for use of the claim “healthy” if their RACC sizes were similar to those of typical individual foods and if they met all the other requirements for the use of the claim (Ref. 2).

FDA has previously addressed challenges related to foods with small RACCs in its nutrition labeling regulations. For example, in the context of eligibility for “low” nutrient content claims, FDA provided different criteria for eligibility to use the “low fat” claim based on the RACC of the individual food (§ 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 nutrient-dense foods encouraged by the Dietary Guidelines. The comments request that we expand the exemption for raw, whole fruits and vegetables to other single-ingredient nutrient-dense foods recommended by the Dietary Guidelines or include an additional category for nutrient-dense whole foods recommended by the Dietary Guidelines to ensure that these types of foods can also qualify for the “healthy” claim without needing to meet the FGE and NTL criteria.

(Response 9) We do not intend to exclude nutrient-dense single-ingredient foods that are foods encouraged by the Dietary Guidelines from qualifying for the updated “healthy” definition. We agree that it is not necessary for such foods to meet additional criteria because they are nutrient-dense foods encouraged by the Dietary Guidelines that can help consumers maintain healthy dietary practices by serving as a foundation for a healthy dietary pattern. Therefore, we have revised the rule to expand the exemption for raw, whole fruits and vegetables to include individual foods or mixed products that are comprised of one or more of the following nutrient-dense foods encouraged by the Dietary Guidelines (for adults and children 2 years of age and older), with no other added

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 shelf-stable and/or economical forms of foods. For example, frozen or sliced fruits and vegetables, 100% whole grain flours, dried beans, peas, and lentils, frozen seafood, chopped nuts, and certain nut butters (

i.e.,

only containing nuts), with no added ingredients other than water, automatically qualify without needing to meet the FGE and nutrient to limit requirements. Additionally, as a result of the expansion of this exemption, single-ingredient foods encouraged by the Dietary Guidelines that have small RACC sizes (

e.g.,

frozen avocado pieces) will now qualify even if their RACCs are smaller than the FGE amounts for their respective food groups or subgroups.

Certain mixed products are also eligible for the exemption. A mixed product that contains multiple single-ingredient foods encouraged by the Dietary Guidelines (without additional ingredients besides water) but does not meet the FGE requirements for a mixed product to qualify for “healthy” (

i.e.,

contain 1 total FGE) will fall under the expanded exemption and will automatically qualify for the claim (§ 101.65(d)(3)(i)). We have determined that these types of products (

i.e.,

mixed products that contain only nutrient-dense foods that are encouraged by the Dietary Guidelines without added ingredients besides water) can also serve as part of a foundation for a healthy dietary pattern because of their nutrient profile and positive contribution to an overall healthy diet. Many of these types of products, regardless of whether they are individual foods or mixed products, would also meet the FGE and NTL criteria for individual foods or mixed products; however, this exemption allows manufacturers to more easily determine and verify compliance with the updated “healthy” criteria, particularly for mixed products. For example, a product that contains two ingredients that are each a food encouraged by the Dietary Guidelines—such as a frozen mix of a vegetable and a whole grain, or a blend of 100% juices that contains 80% fruit juice and 20% vegetable juice—and does not contain additional ingredients besides water, will automatically qualify under the expanded exemption in § 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 entrée 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 entrée, 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 single-ingredient foods with no added ingredients, except for water (

e.g.,

a frozen mix of a vegetable and a whole grain, or a blend of 100% juices that contains 80% fruit juice and 20% vegetable juice).

(Comment 10) Some comments also recommend that herbs and spices be able to qualify for the “healthy” claim. These comments assert that herbs and spices can reduce consumption of added sugars, sodium, and saturated fat by making nutrient-dense foods more palatable without adding calories. Additionally, the comments state that herbs and spices increase the consumption of nutrient-dense foods such as vegetables, fruits, and healthy grains. Some comments assert that spices meet the definition of vegetable products, but provide that given their small RACC, spices would not be able to meet the proposed FGE criteria.

(Response 10) We agree that herbs and spices can play an important role in the diet by replacing seasonings and ingredients that contribute sodium, saturated fat, and added sugars to the diet. They can also help increase the palatability of nutrient-dense foods. However, because of their primary use

as a flavoring for foods, they are typically consumed in such small quantities that they generally do not contribute a meaningful amount of nutrients to the diet. The

Dietary Guidelines, 2020-2025

mentions that spices and herbs can help flavor foods when reducing added sugars, saturated fat, and sodium, and that they can also contribute to the enjoyment of nutrient-dense foods (Ref. 1). Some herbs are included as examples in the vegetable food group in the

Dietary Guidelines, 2020-2025

(

e.g.,

cilantro, basil, and chives). Foods or ingredients that are considered to be part of the vegetable food group can also contribute toward the FGE requirement for vegetables in different forms, such as dried forms (see Response 44).

(Comment 11) Some comments suggest that FDA allow foods with small RACCs to satisfy their FGE requirement by having a component from a recommended food group as the first ingredient on the ingredient declaration. The comments suggest this “first ingredient” approach both for foods with small RACCs and as an alternative to the FGE requirement, not limited to foods with small RACCs. In the “first ingredient” approach, there would be no absolute amount of a food group required; the approach would require only that the component from a qualifying food group would be the ingredient of the greatest weight in a food.

(Response 11) We decline to adopt the “first ingredient” approach suggested by the comments. The regulations regarding ingredient declaration require only that ingredients be listed in descending order of predominance by weight (21 CFR 101.4(a)). A descending order by weight does not, however, provide any indication of a significant or meaningful amount of an ingredient. Being listed first in the ingredient declaration only indicates that a food has proportionally more of that ingredient compared to each of the other ingredients individually. For example, a food could contain 10 different ingredients, and, although the first ingredient may weigh more than each of the other nine ingredients individually, the total sum of the other nine ingredients could proportionally outweigh the first ingredient. The overall food in that case would not be likely to have a significant amount of the first ingredient from a recommended food group and therefore would not meaningfully contribute to the recommended daily food group amounts. Therefore, using the first ingredient in an ingredient list to determine FGEs would not be a reliable way to help consumers identify foods that can help them meet recommended food group amounts, nor would it effectively address challenges related to the qualification of foods with small RACCs. As discussed in Response 8, the rule includes criteria specific to small RACC foods.

(Comment 12) Many comments request that FDA provide more guidance on what counts as an FGE and how to calculate the FGE contribution of a food. The comments note that the proposed FGE amounts are in volume, and that the volume of a food will vary considerably based on the form of the food. Some comments ask that FDA provide a standard methodology, calculator, and/or database that manufacturers could use to determine FGEs for their products.

(Response 12) We determined FGE amounts based on the cup- and ounce-equivalents developed for the Healthy U.S.-Style Dietary Pattern for ages 2 and older in the

Dietary Guidelines, 2020-2025

(Ref. 1). The

Dietary Guidelines, 2020-2025

provides information on the many types of foods that are contained in each food group in the food patterns (see Ref. 1, Appendix A3-2, footnote b) and descriptions of how much of those foods are needed to meet a cup- or ounce-equivalent (see Ref. 1, Appendix A3-2, footnote c). Additionally, there are other resources available, such as the FPED, which provides further information about cup- and ounce-equivalents of different foods and beverages (Ref. 3). FDA understands that, depending on the type and form of an individual food, manufacturers may benefit from additional information on how to determine the amount necessary to meet the FGE amounts required for their foods to be eligible for the “healthy” claim. The final rule sets a compliance date that is 3 years from the effective date, and we intend to provide additional resources to help manufacturers comply with the final rule before the end of the compliance period. The additional resources may take the form of guidance documents for industry, information on the FDA website, FAQs, direct communications in response to questions, or online webinars, as discussed in Response 6.

(Comment 13) Many comments request that FDA make clear that the list we provided for FGEs in the preamble to the proposed rule is not exhaustive.

(Response 13) The marketplace for food products is wide in scope and continually evolving and therefore cannot be comprehensively covered by the examples of FGEs described in this rule. Thus, the list of examples of FGEs we provided in the proposed rule and in the final rule is not an exhaustive list.

2. FGEs Based on Four Eating Occasions Per Day

(Comment 14) Some comments express concern with the assumption in the proposed rule that the typical American dietary pattern consists of three meals and one snack per day (

i.e.,

four eating occasions). The comments assert that the dietary habits of Americans have shifted over the past several years from a primarily meal-based diet to one that includes more snacking or “ready to eat” meals. The comments suggest that FGEs should not be based on a consumption pattern of four eating occasions per day. Another comment notes that the recommendations in the

Dietary Guidelines, 2020-2025

were based on the assumption that Americans consume three meals per day and two snacks.

Some comments question the equal division among the four eating occasions. For example, some comments suggest that snacks should be weighed differently than meals due to size. One comment recommends that meals carry three times the ounce equivalent (oz-eq) as a snack for the nutrient recommended daily allowance.

(Response 14) Our review of consumption patterns indicates that the typical American dietary pattern consists of three meals and one snack per day,

i.e.,

four eating occasions (not including beverage-only eating occasions) (Ref. 2). These data signify that individuals have four opportunities in a day to meet the recommended daily food group amounts in the Healthy U.S.-Style Dietary Pattern, and thereby satisfy their nutritional needs. The food group amounts recommended by the

Dietary Guidelines, 2020-2025

(

e.g.,

2 c-eq/day of fruit) are total recommended amounts for the day, not for individual foods, meals, or snacks. The recommended daily amounts of food groups provided by the

Dietary Guidelines, 2020-2025

are not dependent on number of eating occasions. In determining the food group requirements for “healthy,” the total daily amount of food groups are divided across the number of eating occasions as determined by the data from national consumption surveys. National consumption data over the last several decades, (

i.e.,

the USDA Continuing Survey of Food Intakes by Individuals 1989-91 and Diet and Health Knowledge Survey 1989-91 (CSFII/DHKS 1989-1991) through the 2015-2016 National Health and Nutrition Examination Survey

(NHANES)) (Refs. 2, 36, and 37) demonstrate that the highest percentage of the U.S. population ages 4 and older reported four eating occasions per day. Note that we excluded beverage-only eating occasions from our analysis of the 2015-2016 NHANES data to focus only on eating occasions that provided consumers with a meaningful opportunity to consume foods from all the recommended food groups.

While some comments question the equal division among the four eating occasions, we decline to change this method for the final rule. For this rule, we analyzed the most current national consumption data, the 2017-March 2020 NHANES (Refs. 2 and 38), and determined that the median number of eating occasions (meals plus snacks) per day continues to be four eating occasions (not including beverage-only eating occasions) (Refs. 2 and 38). The data from NHANES 2017-2020 describe both the number of meals eaten per day and the number of snacks eaten per day. The data demonstrate that the highest percentage of people reported eating three meals per day. The highest percentage of people also reported eating one snack per day. Analysis of the combined eating occasion data show that the highest percentage of people reported having four eating occasions per day (meals plus snacks). We note that a study cited in the comments examined the same NHANES data that we used in our analysis. However, the study considered reports of beverage-only occasions whereas we excluded beverage-only occasions. Therefore, total number of eating occasions are different.

The typical sizes of meals and snacks may differ but are not weighted differently when dividing the recommended daily food group amounts to determine the FGE amounts. This is because the meals and the snack are all eating occasions that provide consumers with an equal opportunity to consume foods from the recommended food groups. For example, the recommended daily amount for fruit is 2 cups per day, and consumers have the opportunity to consume fruit at all three meals and at a snack. Therefore, it is reasonable to divide the recommended daily amount for fruit among the four eating occasions equally, which results in an FGE amount of

1/2

c-eq of fruit (2 c-eq divided by four eating occasions). We further note that this method is consistent with FDA's method in previous labeling rulemakings and relies on the same rationale (see final rules on general requirements for health claims and nutrient content claims in food labeling, 58 FR 2478 at 2495 and 58 FR 2302 at 2379-2380).

3. FGEs for Vegetables

(Comment 15) Some comments request that FDA provide more guidance on how to convert various forms of fruit and vegetable groups into a

1/2

c-eq vegetables per RACC that we proposed as the FGE amount for vegetables, taking into consideration the changes in density that occur from processing steps such as chopping, pureeing, grating, and cooking. The comments also ask that FDA provide guidance on how to convert dried fruits and vegetables, including those in powdered forms, into the whole equivalent “single strength” form for purposes of determining the food group contribution.

(Response 15) We are aware that the examples of FGEs described in the proposed rule did not represent all possible forms of foods, including different forms of vegetable products, such as chopped, dried, or grated vegetables. However, as noted in the proposed rule, the FGEs are based on the cup- and ounce-equivalents developed for the

Dietary Guidelines, 2020-2025

(Ref. 1). The

Dietary Guidelines, 2020-2025

and the FPED (Ref. 3), which is used to develop the Healthy Dietary Patterns for the guidelines, provide detailed information about cup- and ounce-equivalents of different foods and beverages and are resources that can help manufacturers determine the appropriate FGE amounts. For example, the FPED describes that sliced, diced, or chopped raw vegetables are given the same cup weight and the cup weights are typically the average weights of different cuts. The FPED provides the example of raw carrots which are assigned a 125-gram cup weight, which is an average of one cup of sliced (122 g) and chopped (128 g) carrots (Ref. 3). We note that, as explained in Response 44, vegetable powders may be considered in the calculation of vegetable FGEs, which represents a change from the proposed rule.

(Comment 16) Some comments support FDA's approach to include FGEs in the proposed “healthy” criteria on the basis that it would encourage increased consumption of fruits and vegetables but assert that the proposed approach to FGEs may limit products that can meet the requirements because they do not provide the required amount of FGEs. The comments assert that FDA should allow products to count “partial FGEs,” which could allow additional products to meet the FGE requirement for vegetables.

(Response 16) As explained in Response 8, we do not intend to exclude foods consumed in small amounts that are recommended for healthful dietary patterns, including various vegetable products. Thus, we revised the rule at § 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 nutrient-dense forms of fruits and vegetables (as well as to foods in other food groups). The expanded exemption will result in more fruit and vegetable products (

i.e.,

single-ingredient fruits and vegetables without added ingredients besides water) qualifying for “healthy,” regardless of their RACC size (

e.g.,

chopped or frozen fruits and vegetables). This single-ingredient exemption is discussed in Response 9.

(Comment 17) Some comments urge FDA to consolidate the food groups for fruits and vegetables. The comments assert that combining the fruit and vegetable food groups would avoid “arbitrary distinctions” for products that contain a mixture of fruits and vegetables, and that a product that contains meaningful amounts of fruits, vegetables, or fruits and vegetables together should be treated the same, regardless of the precise contribution to the fruit group versus the vegetable group. One comment requests that FDA combine the fruit and vegetable groups for children ages 1-3 to provide flexibility for foods that contain meaningful amounts of fruits and vegetables collectively.

(Response 17) We decline to combine the fruit and vegetable food groups in this final rule. Fruits and vegetables are considered different food groups in the Dietary Guidelines and have separate daily recommended intake amounts. As noted on the MyPlate website (

https://www.myplate.gov/

), while botanically, most vegetables are considered fruits, the two groups are separated for nutritional and culinary purposes, meaning distinctions are made based on nutrient content, use in meals, and taste (

e.g.,

fruits are generally considered sweet or tart, while vegetables are not). Each food group provides a particular array of nutrients, and the recommended intake amounts of the different food groups reflect dietary patterns that are associated with positive health outcomes (Ref. 1). Healthy dietary patterns include intakes of foods from across the different food groups recommended by the Dietary Guidelines, including the fruit and vegetable food groups. Thus, vegetables

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 single-ingredient exemption.

4. FGEs for Fruits

(Comment 18) Some comments request that FDA provide more guidance on how to convert various forms of fruit and vegetable groups into a

1/2

cup, taking into consideration the changes in density that occur from processing steps such as chopping, pureeing, grating, and cooking. One comment notes that moisture and solid levels vary among fruits and vegetables, and the conversion of 1 cup fresh or cooked fruits or vegetables to

1/2

cup dried fruits and vegetables may not accurately reflect all types of fruits and vegetables. The comment requests that FDA allow food companies flexibility to use reasonable options for determining FGEs of their products when converting between dried and rehydrated forms of fruits and vegetables.

(Response 18) We recognize that additional information on FGEs may be helpful and we respond to the comments requesting options for determining FGEs for different forms of fruit products, such as dried and rehydrated fruits (with regard to both vegetables and fruits) above in section V.C.3 (“FGEs for Vegetables”). We also provide information about available resources to support the determination of FGE amounts in Response 6 and 12.

(Comment 19) A number of comments do not support a “healthy” claim being on 100% fruit juice. One comment provides that, although 100% fruit juice in small amounts may offer a way for people to obtain important nutrients and contribute to dietary recommendations for fruit intake, 100% fruit juice is likely to be overconsumed because of its high palatability and accessibility. The comment says that the presence of a “healthy” claim may promote excess consumption of 100% fruit juice, which could contribute large amounts of unnecessary calories and sugar to the diet. Some comments note that the

Dietary Guidelines, 2020-2025

provides that whole fruit is the preferred way to meet the recommended fruit intake amounts.

(Response 19) We disagree that 100% juice should not be able to qualify to bear the “healthy” claim. The

Dietary Guidelines, 2020-2025

states that foods in the fruit food group include both whole fruits and 100% juice, and the Healthy U.S.-Style Dietary Pattern for ages 2 and older includes 100% juice as a food that contributes to the healthy dietary pattern. As discussed in the 2020 DGAC report, 100% juice is a nutrient-dense food that does not contribute energy through added sugars and contributes to meeting nutrient and food group needs (Ref. 8). The comments suggesting that 100% fruit juices being labeled as “healthy” may promote excess consumption do not provide evidence that would contradict or cause us to question the

Dietary Guidelines, 2020-2025.

As discussed elsewhere, the purpose of this rule is to help consumers identify foods that are particularly useful in creating a diet that is consistent with dietary recommendations. Based on the contributions of 100% juice, including both fruit and vegetable juice, to healthy dietary patterns as presented in the

Dietary Guidelines, 2020-2025

and Healthy U.S.-Style Dietary Pattern for ages 2 and older, we are including 100% fruit and vegetable juice among foods that are eligible to bear the “healthy” claim (Ref. 1). Additionally, we include in this rule a single-ingredient exemption for nutrient-dense foods that are encouraged by the Dietary Guidelines with no added ingredients, except for water (see Response 9).

(Comment 20) Some comments do not support fruit puree and fruit paste being able to qualify for the “healthy” claim because, according to the comments, they often do not contain fiber-containing parts of the whole fruit and are seldom consumed independently. For example, if the whole fruit or vegetable is not used in making the purees or pastes, such as if the skin is removed from apples before making applesauce, then the purees could have lower fiber content than the whole fruit or vegetable.

(Response 20) As stated in the proposed rule (87 FR 59168 at 59184), FDA considers concentrated fruit and vegetable purees and pastes to be fruits and vegetables for the purpose of calculating FGEs because these products are essentially fruits and vegetables that have been processed to change the physical form of the fruit or vegetable and to remove moisture. While removal of the skin of fruits and vegetables for concentrated fruit and vegetable purees and pastes may affect total fiber content compared with whole, intact fruits and vegetables, the

Dietary Guidelines, 2020-2025

includes purees, such as applesauce, in the food groups for fruits without qualification related specifically to fiber content. Fruits and vegetables provide a wide array of nutrients and are consumed in a wide variety of forms. Some forms of fruits and vegetables are consumed without skins, even when the skins are edible, such as in canned and frozen varieties. Even with the removal of fruits and vegetable skins, the overall nutrient profiles of purees and pastes remain within the range of the varied available forms of fruits and vegetables. For the development of the Healthy U.S.-Style Dietary Pattern, the FPED also included applesauce puree with a c-eq of 245 g. Similarly, pastes, such as tomato paste, are included in the food group for vegetables and the FPED provides a c-eq of 120 g. Fruit and vegetable purees and pastes are foods that are included in the fruit and vegetable food groups in the Dietary Guidelines. Thus, under the final rule, fruit and vegetable purees and paste are eligible to bear a “healthy”

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 ounce-equivalents of grain foods per day, with at least half of those being whole grains. According to the comment, under the proposed rule, foods with 8 g whole grain per oz-eq that meet the nutrient limits for saturated fat, added sugars, and sodium would not qualify for the “healthy” claim. The comment suggests that FDA align the whole grain threshold with the recommendations in the

Dietary Guidelines, 2020-2025

of 8 g per oz-eq. The comment also recommends that the requirements for the whole grain criteria be provided in grams present per reference amount.

(Response 22) Although the

Dietary Guidelines, 2020-2025

provides individuals with multiple strategies to facilitate shifts in eating habits, the primary objective of the food group recommendations is to help consumers meet the recommended 3 oz-eq of whole grains per day. Both the

Dietary Guidelines, 2020-2025

and the FPED explain that a 1 oz-eq of whole grains is 16 g of whole grains. The comments suggest that the criteria should align with one of the strategies to facilitate shifts in eating habits discussed in the

Dietary Guidelines, 2020-2025

to choose foods whose grain components are comprised of at least 50% whole grains, which would be 8 g per oz-eq. However, the FGE requirement for whole grains included in the updated “healthy” criteria is based on the Dietary Guidelines' recommended amount of 3 oz-eq of whole grains per day. To determine the amount of FGE required for a food to bear the “healthy” claim, the recommended daily food group amounts are divided among the four eating occasions typically consumed. Consequently, the rule sets the FGE for grains at

3/4

oz-eq of whole grains (see § 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,

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 oz-eq of whole grains, which would be equal to 6 g of whole grains, can qualify on a per 50 g basis. The calculated amount of whole grains in that food would be 20 g of whole grains per 50 g (50 g divided by 15 g and then multiplied by 6 g and then rounded up to 20 g). This food qualifies for the FGE of

3/4

oz-eq (12 g). Therefore, lowering the FGE amount, as suggested in the comment, is unnecessary, and the

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 low-fat forms, to be unable to bear the “healthy” claim, based solely on the amount of serving equivalents set by the

Dietary Guidelines, 2020-2025

and the defined RACCs. The comments also state that it may be difficult to determine whether a cheese is eligible for a healthy claim, because cheeses have varying weights and densities.

(Response 29) In response to these comments, we reviewed the current marketplace related to the RACC sizes of different dairy products and the amounts of FGEs contained in those foods (Ref. 2). This review showed that the comments were correct that a number of dairy foods, including some cheeses and many yogurts, would not meet the proposed FGE of

3/4

c-eq of dairy. However, the amount of dairy in many of those products was close to meeting the FGE amounts (ranging from about 0.69 to 0.71 c-eq per RACC). Dairy products, including milk, yogurt, and cheese, especially in fat-free and low-fat forms, are included in the

Dietary Guidelines, 2020-2025

as core elements of healthy dietary patterns. Although the proposed FGE threshold was set to help consumers identify foods that could help them meet the recommended daily amount of dairy, we do not intend to exclude nutrient-dense foods that are recommended for healthful dietary patterns. We have already addressed the issue of foods with small RACCs in Response 8 and the methods provided for addressing small RACC foods will result in many dairy foods with small RACCs, such as natural cheeses, being able to meet the FGE amounts. However, there are some other dairy foods that do not have small RACCs and that still would not meet the FGE amounts. Therefore, we have revised the FGE threshold for dairy in the rule to

2/3

c-eq per RACC (see § 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

for dairy difficult. Requiring a minimum of

2/3

c-eq for the dairy FGE to meet the FGE requirement for the “healthy” claim would enable consumers to identify dairy products that would help them approach meeting the daily recommended amounts for dairy and result in many nutrient-dense dairy options qualifying for the “healthy” claim. We note that the FGE amounts are criteria for manufacturers to use when determining if a product qualifies for the “healthy” claim. The presence of a “healthy” claim on a product that meets the criteria will simply help consumers to identify foundational foods for building healthy dietary patterns. To support this goal, we intend to engage in consumer education efforts related to the “healthy” claim.

(Comment 30) One comment notes that there are disparities in dairy consumption related to race and ethnicity, with non-Hispanic Black and Asian children and adults consuming the least amount of dairy. The comment also mentions that lactose intolerance is significantly more prevalent among Black and Hispanic Americans than in non-Hispanic white populations, and that natural cheeses such as cheddar, mozzarella, and Monterey Jack are “virtually lactose-free” dairy options upon which individuals with lactose intolerance rely. According to the comment, limiting the labeling of cheese as a “healthy” food could further widen the disparity gap in dairy consumption. The comment asserts that dairy consumption needs to be encouraged across age, race, and ethnic groups to achieve the daily dairy recommendation as a part of healthy eating patterns to help advance health equity. Some comments note that plant-based dairy foods are alternative dairy sources for those with lactose intolerance.

(Response 30) The criteria for foods to bear the “healthy” claim are intended to help consumers identify foods that are foundational to a healthy dietary pattern. As noted in Response 29, we have lowered the FGE amount for dairy to

2/3

c-eq, which will result in more dairy foods being able to meet the FGE requirements for the “healthy” claim and may result in more dairy options labeled as “healthy” for consumers to choose from (

e.g.,

more yogurts). There are other options in the dairy group for individuals who are lactose intolerant that could qualify for “healthy,” such as certain lactose-free versions of dairy products or certain dairy products that are naturally lactose-free. Also, fortified soy milk, and plant-based dairy alternatives with similar nutrient composition as dairy are included in the dairy food group for the purposes of the “healthy” claim, which can provide alternatives to individuals who are lactose-intolerant. The

Dietary Guidelines, 2015-2020

discusses that key nutrient contributions from dairy foods include calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, vitamin B12, zinc, choline, and selenium (Ref. 4). As we noted earlier in this rule, while not all dairy foods may qualify for use of the claim, the use of the “healthy” claim on some foods is not intended to signal that all other foods are “unhealthy,” including foods consumed by certain subgroups of the population (see section III.A (“Need for the Regulation/History of This Rulemaking”). Other foods are still available for consumption and manufacturers can communicate truthful and non-misleading information about lactose-free foods or information that encourages culturally appropriate consumption of dairy foods on the food label outside of use of the “healthy” claim.

(Comment 31) Some comments assert that ambiguity in the determination of the FGEs of certain dairy foods, including yogurt, could lead to inconsistency in manufacturer calculations of FGEs and confusion among consumers. A number of comments request that FDA provide a list, examples, or maintain a database for manufacturers to use in calculating the amount of FGEs delivered by each food.

(Response 31) The comments on the dairy FGEs echoed the requests in the comments across the food groups for guidance in determining the FGE amounts for foods in this group. We provide a general discussion on available resources to support determination of FGE amounts in Response 12. For example, fluid milks and yogurts are calculated at 245 g for a one c-eq in the FPED database (Ref. 3). As noted in Response 12, the final rule sets a compliance date that is 3 years from the effective date, and we intend to provide additional resources to help manufacturers comply with the final rule before the end of the compliance period.

(Comment 32) Some comments request guidance regarding what dairy alternatives might be considered “healthy.” Some comments note that, according to the Dietary Guidelines, alternative beverages such as almond, rice, coconut, or hemp milks are not nutritionally equivalent to milk and are therefore not included in the dairy foods group. The comments note that dairy foods contribute nutrients such as calcium, vitamin D, and potassium to the American diet. One comment provides that, according to the Dietary Guidelines, only fortified soy products are nutritionally similar to dairy products and can serve as a replacement to dairy products. However, other comments support the inclusion of plant-based dairy alternatives in the dairy group. The comments mention that many people do not consume dairy products for a variety of reasons, such as allergy, intolerance, cultural practices, or preference. Many comments that support inclusion of plant-based dairy alternatives in the dairy group request that FDA set forth specific nutritional criteria that plant-based dairy alternatives must meet to qualify for the “healthy” claim. One comment asserts that if FDA permits nutritional comparisons between plant-based and traditional dairy products through the use of the term “healthy,” then FDA should require the plant-based products to bear the imitation labeling outlined in § 101.3(e) (21 CFR 101.3(e)).

(Response 32) In the proposed rule (87 FR 59168 at 59187), we determined that including fortified plant-based dairy alternatives among the food options in the dairy group can help consumers identify foods that can help them increase their dairy group intake and meet the dairy group daily intake recommendations. We specifically limited plant-based milk alternatives and plant-based yogurt alternatives that could qualify for the claim to those products whose overall nutritional content is similar to dairy foods (

e.g.,

provide similar amounts of protein, calcium, potassium, vitamin D, and other nutrients) and are used as alternatives to milk and yogurt. We discussed in the proposed rule that, when the

Dietary Guidelines, 2020-2025

published, fortified soy beverages and yogurts were the only alternatives that were nutritionally comparable to dairy, and the composition data evaluated by the

Dietary Guidelines, 2020-2025

demonstrated that the nutrient content in fortified soy beverages and yogurts is similar to that of dairy. Plant-based dairy alternatives are formulated foods, with evolving compositions and formulations. It is possible that plant-based dairy alternatives from sources other than soy, such as almond milk or oat milk, may be produced with nutritional profiles similar to dairy. If plant-based dairy alternatives are formulated with nutritional profiles similar to that of dairy, then it would be appropriate for those products to be considered among the food options in the dairy group. Although not mentioned in the proposed rule, in

addition to plant-based milk and yogurt alternatives, plant-based cheese alternatives are also available on the market. Currently, these plant-based cheese alternatives do not have similar nutrient composition to cheese. However, as with plant-based milk and yogurt alternatives, it is possible that in the future plant-based cheese alternatives may be produced with nutritional profiles similar to that of dairy. If those food products were to become available, they would be considered under the criteria for the dairy group to qualify for use of the “healthy” claim. We reiterate that, for purposes of this rule, it is only those plant-based dairy alternatives that have similar nutrition composition to dairy that will be included in the dairy group for purposes of qualifying for the “healthy” claim. For example, soy-based yogurt alternatives would need to have similar nutrient composition to traditional milk-based yogurt. Plant-based milk alternatives would, likewise, need to have similar nutrient composition to milk to be considered under the criteria for dairy foods in this rule. While nutrient profiles can vary among different dairy foods, the

Dietary Guidelines, 2015-2020

discusses that key nutrient contributions from dairy foods include calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, vitamin B12, zinc, choline, and selenium (Ref. 4). We note that FDA has also published a draft guidance on the labeling of plant-based milk alternatives, and we requested comment on nutrient profiles of plant-based milk alternatives (Ref. 5). Requiring plant-based products to bear imitation labeling as outlined in § 101.3(e) is outside the scope of this rule.

(Comment 33) Some comments question the use of FGEs, cup- and ounce-equivalents for the criteria for dairy foods. One comment notes that FDA has departed from the use of a defined gram-basis, the RACC, or labeled serving size as the basis for the “healthy” claim, without explanation. The comment urges FDA to consider a basis that is specific to certain types of dairy foods or the RACC.

(Response 33) The claim “healthy' is a nutrient content claim and the criteria are applied on a per RACC basis, as is typically the case with nutrient content claims. The NTL criteria in the “healthy” definition are based on grams or milligrams per RACC, similar to other claims, but are reflected as percentages of the DV to allow flexibility in the future if there are changes in the DV for these nutrients. The FGE criteria introduced in the “healthy” definition are applied on a cup- and ounce-equivalent per RACC basis to be consistent with how food group recommendations are provided for in relation to dietary patterns. The

Dietary Guidelines, 2020-2025

provides food group recommendations in cup- and ounce-equivalents, such as 3 c-eq of dairy per day for a reference 2,000-calorie diet. The daily recommended amounts of the food groups are spread out throughout the day across an individual's eating occasions. Therefore, the amounts per eating occasion are also in cup- and ounce-equivalents. The concept of equivalents, however, incorporates the calculation of the specific gram weights of individual foods. In the example used earlier in this section for fluid milk and yogurt, 245 g is a one c-eq, as calculated in the FPED database. Calculating the FGE of

2/3

c-eq results in an FGE amount of approximately 163 g for milk and yogurt. The use of cup- and ounce-equivalents allows for the calculation of specific amounts of foods that exist in a wide variety of forms.

(Comment 34) One comment asserts that FDA is providing plant-based dairy alternative products a competitive advantage because manufacturers of these products may choose between two different FGEs (protein foods or dairy).

(Response 34) As discussed in Response 35, there are some foods, namely beans, peas, and lentils, that may be considered under either the protein or the vegetable food group for calculation of FGEs. However, plant-based dairy products that are labeled and marketed as dairy alternatives will be evaluated against the criteria for the dairy food group for the purposes of the “healthy” claim, as discussed in Response 32. Therefore, manufacturers of plant-based dairy alternative products are not able to choose between two different food groups for the calculation of FGEs.

7. FGEs for Protein Foods

(Comment 35) One comment says that dry beans, dry peas, lentils, and chickpeas, known as pulses, are rich sources of protein, potassium, and dietary fiber, and provide other important minerals, such as magnesium, choline, and iron, and minimal amounts of added sugar, saturated fat, and sodium to the diet. The comment supports FDA's proposal to permit beans, peas, and lentils to be categorized as either a vegetable or a protein under the rule because the nutrient content is similar to other foods in both the protein and vegetable groups. The comment asserts that pulses are emerging in a variety of new forms, including flours, powders, spreads, purees, pastas, and proteins, and can be used in a wide variety of applications, such as pastas, plant-based entrees, baked goods, and beverages. The comment asserts that these varying forms contain the same nutritional benefits of pulses in their whole form and maintains that FDA should provide flexibility to allow for innovative pulse products to qualify as “healthy.”

Other comments request that other sources of protein, including protein powders, isolates, and concentrates from whey, soy, and pea, be included in the protein foods group. The comments note that the

Dietary Guidelines, 2020-2025,

includes soy flour, soy protein isolate, and soy concentrate in the protein group and provides that soy includes tofu, tempeh, and products made from soy flour, soy protein isolate, and soy concentrate. The comments assert that all plant-based proteins should be considered part of the protein foods group.

(Response 35) In the proposed rule (87 FR 59168 at 59185), we stated that for individual foods, the nutrient content of beans, peas, and lentils is similar to foods in both the protein foods group and in the vegetable group and may be counted under either food group. Similarly, for combination foods, we proposed that beans, peas, and lentils could be counted as either a protein food or as a vegetable in a combination food (87 FR 59168 at 59191). Our position has not changed on beans, peas, and lentils and these foods can be considered under either of those food groups to qualify for the claim in this final rule. For consideration as vegetables, the FGEs for beans, peas, and lentils is

1/2

c-eq per RACC and for consideration as protein foods, the FGE is 1 oz-eq per RACC, consistent with the

Dietary Guidelines, 2020-2025

(§ 101.65(d)(3)(ii)).

The daily recommendation for protein foods in the Healthy U.S.-Style Dietary Pattern at the 2,000-calorie level is 5

1/2

oz-eq. For all the food groups, we calculated the FGE by dividing the daily amount by four eating occasions (5

1/2

oz equivalents of protein foods divided by four is 1

3/8

oz-eq). For the beans, peas, and lentils sub-category of protein foods, we set the FGE at 1 oz-eq, which is lower than 1

3/8

oz-eq. We proposed rounding down to 1 oz-eq to increase the number of products containing these subgroups that would be eligible to bear the claim, consistent with the

Dietary Guidelines, 2020-2025,

which encourages consumption of such products (87 FR 59168 at 59188). The rule maintains the 1 oz-eq FGE for beans, peas, and lentils as it provides

sufficient flexibility for a variety of options of nutrient-dense protein foods, including pulses, to be eligible for the claim, which may help consumers identify foods that help them meet the daily recommended amount of protein foods. We decline to include protein isolates and concentrates when calculating what meets the FGE requirement for the protein group. The

Dietary Guidelines, 2020-2025

recommends following a healthy dietary pattern with a focus on meeting food group needs by consuming a variety of nutrient-dense foods and beverages and staying within calorie needs. Although the

Dietary Guidelines, 2020-2025

includes soy protein isolates and concentrates among examples of foods in the protein foods group, these components will not count toward meeting the FGEs for the protein foods group in the rule. The food group approach to the “healthy” claim represents a shift from focusing on individual nutrients to nutrient-dense foods. Nutrients that are extracted from foods, such as isolates and concentrates, are not whole, nutrient-dense foods but rather, individual nutrients such as those included in the original definition for the “healthy” claim. Because of the shift in the framework toward foods rather than individual nutrients, counting isolated or concentrated protein toward the protein FGEs would not be consistent with the “healthy” claim's focus on nutrient-dense foods that serve as the foundation of healthy dietary patterns. The presence of extracted components, such as isolates or concentrates, and information about any potential benefits, however, may be useful to consumers and manufacturers may communicate this information in other ways, (

e.g.,

nutrient content claims, health claims, and other truthful and non-misleading statements on the label).

(Comment 36) One comment asks that FDA provide additional guidance about converting all forms of pulses into c-eq as a vegetable or into ounce equivalents as protein. The comment mentions that the proposed rule does not include information regarding how to account for changes in volume from processing such as milling, grinding, chopping, pureeing, dehydrating, and cooking, and asks FDA to provide calculation guidance to help in determining compliance with the FGE criteria.

(Response 36) We provide information about available resources to support determination of FGE amounts in Response 12. For example, the FPED provides c-eq for beans and provides amounts for different forms such as cooked, uncooked (dry), and canned (Ref. 3). For varieties of a food that are cut pieces of the whole form, as with beans that are chopped, sliced, or ground, the total amount of food in a c-eq of whole food and the cut food would be the same. As noted in Response 12, the final rule sets a compliance date that is 3 years from the effective date, and we intend to provide additional resources to help manufacturers comply with the final rule before the end of the compliance period.

(Comment 37) One comment requests additional clarity regarding plant-based foods, including how ingredients like chickpea powder or legume powder would be treated and whether pea milk, almond milk, and other plant-based milks, whether fortified or not, would be considered protein foods.

(Response 37) Powders of protein products, such as chickpea powders or legume powders, can be included in FGE calculations provided that the powders are essentially the dried/dehydrated and ground forms of the original, whole food. Powders that have ingredients added to them or components of the food removed from them (other than water) would not be considered a form of the original food for the purposes of the “healthy” claim. The FPED provides an example for legumes, specifically soy flour, which has a 1 oz-eq of

1/2

oz (~14 g) (Ref. 3). Plant-based milk alternatives, such as pea milk or almond milk, would be evaluated against the criteria for the dairy food group and not the protein foods group and are discussed in the dairy section V.C.6 (“FGEs for Dairy”).

(Comment 38) A number of comments seek clarification as to whether coconut is considered a nut. One comment mentions that coconut is currently classified as a tree nut under the Food Allergen Labeling and Consumer Protection Act and provides that the saturated fat of a coconut is inherent to the coconut, as is the case with nuts. Other comments note that they are excluding coconut from their discussion of nuts and seeds (and would not support exclusion of saturated fat content of coconut from the overall saturated fat limit, as was proposed for nuts and seeds) because coconut is unusually rich in saturated fat.

(Response 38) While a coconut is botanically a fruit (specifically, a fibrous one-seeded drupe), the

Dietary Guidelines, 2020-2025

does not include coconuts in the nut or the fruit category. In addition, the FPED database used in the modeling of the U.S. Food Patterns describes the “Nuts and Seeds” category as “Peanuts, tree nuts, and seeds; excludes coconut” (Ref. 3). Instead, the FPED considers coconuts to be solid fats, listing coconuts with other examples of solid fats as “Coconut meat, raw—Raw coconut meat containing 33.5 grams of fat per 100 grams.” Because coconut meat contains total fat amounts of over 33 g per 100 g and most of the fat is saturated (29.7 g per 100 g) (Ref. 7), we have determined that coconuts will not be counted as contributing toward the protein foods group (

i.e.,

will not be considered a nut) or the fruit food group, consistent with the

Dietary Guidelines, 2020-2025.

(Comment 39) Many comments request that FDA enable protein foods with small serving sizes to meet the definition of “healthy.” One comment notes that there are a number of nutrient-dense pulse products, such as hummus and roasted chickpeas, that would fall into the “individual foods” category but have small RACC serving sizes. The comment asserts that even though these foods provide important nutrients like dietary fiber and protein while providing minimal amounts of added sugar, saturated fat, and sodium, it is mathematically impossible for these small serving sizes to provide the minimum amounts of food groups required by the proposed rule criteria. The comment requests that FDA create a pathway for nutrient-dense foods with small RACCs and serving sizes to meet the definition of “healthy.” The comment mentions this could be achieved by allowing products with small RACCs and serving sizes that meet the maximum limits for added sugar, saturated fat, and sodium, to meet the “healthy” definition if their first listed ingredient is an NTE. The comment mentions another approach would be to require a smaller amount of FGE for these smaller sized products, such as

1/4

FGE.

(Response 39) As discussed in Response 8, we do not intend to exclude nutrient-dense foods consumed in small amounts that are recommended for healthful dietary patterns, including certain protein foods. The final rule includes criteria specific to foods with small RACC sizes in § 101.65(d)(3)(iii)(B). Under the small RACC criteria, foods with a small RACC size (≤50 g) need to meet the criteria per 50 g, which will result in many foods with small RACC sizes being able to meet the FGE amounts. Additionally, with the expanded exemption for single-ingredient foods in § 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.

The comments also mention hummus as a food with a small RACC that may not be able to qualify for the claim. Hummus, which has a RACC of 2 Tbsp, is a mixed product with a number of ingredients. Mixed products, such as hummus, would need to meet the applicable FGE amounts in addition to the NTL criteria to qualify for the claim, as discussed in section V.E.2 (“Mixed Products”).

(Comment 40) One comment supports FDA's inclusion of soy foods and soy milk in the rule but requests that we align the rule with FDA's authorized health claims and qualified health claims under 21 CFR 101.14. The comment notes that many soy foods are not eligible for the proposed “healthy” claim even though they are eligible for FDA authorized health claims and qualified health claims.

(Response 40) Foods and food components that are the subjects of health claims that FDA has authorized or for which it considers the exercise of enforcement discretion have an evidence-based relationship of risk reduction with a disease or health-related condition and the language in the health claim communicates this specific relationship. Although many foods that are the subjects of health claims do meet the requirements of the “healthy” nutrient content claim, not all foods that are the subject of a health claim are core elements of a healthy dietary pattern, and therefore would not necessarily qualify to bear the “healthy” claim (see section III. (“Background”) for further discussion of differences between different nutrition labeling claims).

Whether and how a soy food qualifies for “healthy” depends on the food's specific nutrient profile and role in the diet. Some soy foods, such as soybeans, qualify under the single-ingredient exemption (see Response 9). Other foods made from soybeans would be subject to the FGE amounts and NTL criteria for dairy (

e.g.,

soy milk) or for nuts, seeds, and soy products (

e.g.,

tofu) to qualify for the “healthy” claim.

8. FGEs for Oils

(Comment 41) A number of comments express support for FDA's proposal to include oils, which includes 100% oils, certain oil-based spreads

(i.e.,

those whose fat content comes solely from oil), and certain oil-based dressings (

i.e.,

those containing at least 30% oil and made from oils that meet the “healthy” definition) as a food group, viewing this as consistent with current nutrition science. The comments note that the

Dietary Guidelines, 2020-2025

does not categorize oils as a “food group” but emphasizes that oils are one of the six core elements of a healthy dietary pattern and recommends daily intake objectives for oils like the food groups.

Some comments do not support including “oils” as a food group. The comments express that allowing oils to be labeled as healthy may unintentionally communicate to consumers that oils are healthy in any amount and could lead to consumer confusion and overconsumption.

(Response 41) Healthy dietary patterns include foods such as vegetable oils with unsaturated fats and are lower in foods high in saturated fats, such as butter, shortening, lard, or coconut oil (Ref. 1). Strategies to shift intakes toward achieving a healthy dietary pattern include cooking with vegetable oils instead of fats like butter. Therefore, to reflect these shifts, as discussed in the Dietary Guidelines, we conclude it is appropriate for certain oils and oil-based products to qualify for the “healthy” claim. We are not, however, establishing an FGE for oils in foods made with these oils and oil-based products. We disagree with and are not aware of any information in the comments or elsewhere supporting the argument that including oils as a food group for the purposes of this rule may lead to consumer confusion and overconsumption. We note that we do intend to address oil consumption in our consumer education efforts related to the “healthy” claim.

(Comment 42) Some comments do not support allowing oil-based spreads and oil-based dressings to qualify to use the “healthy” claim due to concerns that many of these products contain ultra-processed or highly processed oil or other ingredients.

(Response 42) Oils are characteristic components of healthy dietary patterns, and this determination reflects that current dietary recommendations encourage a shift from use and consumption of saturated fats, such as in butter and many salad dressings, to spreads and dressings made predominantly of unsaturated oils. The oils in these foods may be processed to a greater degree than fats such as butter or lard; however, healthy dietary patterns which include unsaturated oils rather than fats high in saturated fats are associated with positive health outcomes (Ref. 1).

(Comment 43) One comment recommends that the requirement for oil-based dressing to have at least 30% oil be lowered to a level of 10% oil.

(Response 43) The replacement of oils for solid fats in the diet is a key reason for the inclusion of oils as core elements of healthy dietary patterns. Shifts from solid fats to unsaturated oils are important strategies for constructing healthy dietary patterns. Therefore, 100% oils and oil-based dressings and spreads that meet specific requirements can qualify for the “healthy” claim. Foods that are described as “oil-based” for the purposes of the “healthy” claim are not intended to identify foods that simply have oils as an ingredient. Rather, the foods identified as oil-based are intended to be foods where oil is a primary component. At ≥30%, oils would typically make up the largest component in the food, with the exception of water. Lowering the oil requirement to ≥10%, however, would not ensure that the food is an oil-based dressing with oils as the largest component, except for any water present. As discussed in the proposed rule, we did not set qualifying FGEs for the oils group, but instead, limit use of the claim to the oils themselves, oil-based dressings, and oil-based spreads, provided they meet the specified criteria. We decline to lower the minimum amount of required oil in oil-based dressings in the rule to 10% oil, consistent with the purpose of the claim and the

Dietary Guidelines, 2020-2025.

9. FGEs for Fruit and Vegetable Powders

(Comment 44) In the proposed rule, we did not consider vegetable or fruit powders to be vegetables or fruits, respectively, for the purpose of calculating FGEs. Some comments support this approach. One comment asserts that vegetable powders should not qualify as vegetables for purposes of the rule because vegetable powders may be produced or used in a way that modifies the whole vegetable to an extent that removes some essential characteristics that are beneficial when consuming the whole vegetable, which could impact the nutrient content. The comment notes that diets high in vegetables and fruits are beneficial, in part, because the vegetables and fruits displace other less healthy foods, and states that it is unlikely that foods made with vegetable powders would have the same effect. The comment expresses concern that allowing a product with no recognizable vegetable in it to bear the “healthy” claim would send the wrong message to consumers. Another comment agrees with the exclusion of vegetable and fruit powders on the basis that they are often used to create ultra-processed snack foods such as vegetable sticks, puffs, and other snack foods that the comment describes as high in fat and salt and low in dietary fiber.

Other comments recommend that fruit and vegetable powders, or certain fruit and vegetable powders (

e.g.,

those with

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 calcu

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