Rule2024-29957
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 27, 2024
Effective
February 25, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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[Federal Register Volume 89, Number 248 (Friday, December 27, 2024)]
[Rules and Regulations]
[Pages 106064-106165]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29957]
[[Page 106063]]
Vol. 89
Friday,
No. 248
December 27, 2024
Part V
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 101
Food Labeling: Nutrient Content Claims; Definition of Term ``Healthy'';
Final Rule
Federal Register / Vol. 89 , No. 248 / Friday, December 27, 2024 /
Rules and Regulations
[[Page 106064]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2016-D-2335]
RIN 0910-AI13
Food Labeling: Nutrient Content Claims; Definition of Term
``Healthy''
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is issuing this
final rule updating the definition for the implied nutrient content
claim ``healthy'' to be consistent with current nutrition science and
Federal dietary guidance, especially the Dietary Guidelines for
Americans (Dietary Guidelines), regarding how consumers can maintain
healthy dietary practices. This final rule revises the requirements for
when the term ``healthy'' can be used as an implied nutrient content
claim in the labeling of human food products to help consumers identify
foods that are particularly useful as the foundation of a nutritious
diet that is consistent with dietary recommendations.
DATES: This rule is effective February 25, 2025. The compliance date of
this final rule is February 25, 2028.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#3a6a687b694e5b5c5c7a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="a9f9fbe8faddc8cfcfe9cfcdc887c1c1da87cec6df">[email protected]</span></a>.
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
[[Page 106065]]
FDA Response''), our review of the products available in the current
marketplace demonstrates that the updated ``healthy'' criteria allow
affordable, accessible, and culturally preferred \1\ nutrient-dense
foods within different food groups and subgroups to bear the
``healthy'' claim, including frozen, canned, dried, and other shelf-
stable products. This final rule is one part of FDA's broader
commitment to help reduce diet-related chronic diseases and also to
advance health equity by helping consumers to identify foods that can
be the foundation of a healthy dietary pattern. While there has been
consistency in many of the recommendations in Federal dietary
guidelines and the underlying nutrition science on which they are
based, we intend to remain aligned with the most current nutrition
science reflected in Federal dietary guidelines and will continue to
update our regulations and policies, as appropriate.
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\1\ The term ``culturally preferred foods'' is used here to
describe safe and nutritious foods that meet the diverse tastes and
needs of customers based on their cultural identity (Ref. 46).
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B. Summary of the Major Provisions of the Final Rule
This final rule updating the definition of ``healthy'' includes
provisions that:
<bullet> Establish parameters for use of the term ``healthy'' or
derivative terms ``health,'' ``healthful,'' ``healthfully,''
``healthfulness,'' ``healthier,'' ``healthiest,'' ``healthily,'' and
``healthiness'' as an implied nutrient content claim on the label or in
labeling of a food that suggests that a food, because of its nutrient
content, may help consumers maintain healthy dietary practices, where
there is also implied or explicit information about the nutrition
content of the food on the label or in the labeling (Sec. 101.65(d)(1)
and (3)) (21 CFR 101.65(d)(1) and (3))).
<bullet> Establish a framework based on food groups and nutrients
to limit (NTL) for the ``healthy'' claim.
<bullet> Establish that ``food group,'' for the purposes of the
``healthy'' claim, refers to the groups of foods recommended in the
Dietary Guidelines, 2020-2025 (for adults and children 2 years of age
and older), which are vegetables, fruits, dairy, grains, protein foods,
as well as oils (Sec. 101.65(d)(2)).
[cir] The Dietary Guidelines, 2020-2025 does not categorize oils as
a ``food group,'' but they emphasize that oils are one of the six core
elements of a healthy dietary pattern, along with vegetables, fruits,
grains, dairy, and protein foods, and recommend daily intake objectives
for oils, similar to the food groups. Therefore, we include oils as a
food group for purposes of this rule.
[cir] For purposes of this rule, when we refer to foods as
recommended or encouraged by the Dietary Guidelines, 2020-2025, we are
referring to only those foods that are recommended or encouraged for
adults and children 2 years of age or older because that is the
population for which the claim is intended.
<bullet> Establish food group equivalents (FGEs) that identify
qualifying amounts of foods from each food group based on nutritional
content (Sec. 101.65(d)(2)).
<bullet> An FGE contains the following: (Sec. 101.65(d)(2))
[cir] Vegetable--1/2 cup equivalent (c-eq)
[cir] Fruit--1/2 cup equivalent
[cir] Grains--3/4 ounce (oz) equivalent whole grain
[cir] Dairy--2/3 cup equivalent
[cir] Protein foods:
[squf] Game meat--1\1/2\ oz equivalent
[squf] Seafood--1 oz equivalent
[squf] Egg--1 oz equivalent
[squf] Beans, peas, or lentils--1 oz equivalent
[squf] Nuts and seeds, or soy products--1 oz equivalent
<bullet> Require that, to bear a claim subject to this rule,
individual food products, mixed products, main dishes, and meals must
meet FGEs and specific limits for added sugars, saturated fat, and
sodium based on a percentage of the Daily Value (DV) for these
nutrients. To bear a claim that is subject to this rule:
[cir] An individual food that has a reference amount customarily
consumed (RACC, used to determine serving size), greater than 50 grams
(g) or greater than 3 tablespoons (Tbsp) and meets the following
conditions per RACC; or an individual food that has a RACC of 50 g or
less or 3 Tbsp or less and meets the following conditions per 50 g of
food: (Sec. 101.65(d)(3)(ii)(A) and (B))
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[GRAPHIC] [TIFF OMITTED] TR27DE24.002
[cir] A mixed product that meets the following conditions per RACC
(Sec. 101.65(d)(3)(iii)):
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[GRAPHIC] [TIFF OMITTED] TR27DE24.003
[cir] A main dish product as defined in Sec. 101.13(m) (21 CFR
101.13(m)) that meets the following conditions per labeled serving:
(Sec. 101.65(d)(3)(iv))
[GRAPHIC] [TIFF OMITTED] TR27DE24.004
[cir] A meal product as defined in Sec. 101.13(l) that meets the
following conditions per labeled serving: (Sec. 101.65(d)(3)(v))
[GRAPHIC] [TIFF OMITTED] TR27DE24.005
<bullet> Provide that individual foods or mixed products that are
comprised of one or more of the following foods encouraged by the
Dietary Guidelines, with no other added ingredients except for water:
vegetable; fruit; whole grains; fat-free and low-fat dairy; lean meat,
seafood, eggs, beans, peas, lentils, nuts and seeds, automatically
qualify (i.e., without having to meet the FGE and nutrients to limit
(NTL) requirements) for the ``healthy'' claim because of their nutrient
profile and positive contribution to an overall healthy diet. Sec.
101.65(d)(3)(i))
<bullet> Provide that all water, tea, and coffee with less than 5
calories per RACC and per labeled serving automatically qualify for the
``healthy'' claim. (Sec. 101.65(d)(3)(vi))
<bullet> Require the establishment and maintenance of certain
records for foods bearing the ``healthy'' claim where the FGE contained
in the product is not apparent from the label of the food. The records
must be kept for a period of at least 2 years after introduction or
delivery for introduction of the food into interstate commerce. During
an inspection, such records must be provided to FDA upon request for
official review and photocopying or other means of reproduction. (Sec.
101.65(d)(4))
C. Legal Authority
We are issuing this final rule to update the definition of the
implied nutrient content claim ``healthy'' consistent with our
authority in sections 201(n), 403(a), 403(r), and 701(a) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(n), 343(a),
343(r), and 371(a)). We are also relying on our authority under
sections 403(r), 403(a), 201(n) and 701(a) of the FD&C Act for certain
records requirements.
D. Costs and Benefits
In the current marketplace, about 5 percent of all packaged foods
are labeled as ``healthy.'' Because nutrition science has evolved over
time, updating the definition of the implied nutrient content claim
``healthy'' to more closely align with nutrition science underpinning
the Dietary Guidelines, 2020-2025 will better inform consumers who are
selecting those products to choose a more healthful diet, which may
result in lower incidence of diet-related chronic diseases, including
cardiovascular disease (CVD) and type 2 diabetes. Quantifiable benefits
of the rule are the estimated reduction over time in all-cause
mortality stemming
[[Page 106068]]
from consumers that rely upon the ``healthy'' implied nutrient content
claim selecting and consuming more healthful foods. Discounted at 3
percent over 20 years, the mean present value of benefits is estimated
at $686 million, or $46 million annualized. This is calculated through
the inverse association between a Healthy Eating Index score and all-
cause mortality (Ref. 44). Quantifiable costs to manufacturers
associated with updating the ``healthy'' claim are reformulating,
labeling, and recordkeeping. Discounted at 3 percent over 20 years, the
mean present value of costs is estimated at $403 million, or $27
million annualized. Potential costs of rebranding certain foods are
discussed qualitatively. Net benefits are estimated at $283 million, or
$19 million annualized.
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[GRAPHIC] [TIFF OMITTED] TR27DE24.006
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III. Background
A. Need for the Regulation/History of This Rulemaking
In the Federal Register of May 10, 1994 (59 FR 24232), we published
a final rule (the 1994 rule or original rule) entitled ``Food Labeling:
Nutrient Content Claims; Definition of Term `Healthy' '' amending Sec.
101.65(d) to define the term ``healthy'' as an implied nutrient content
claim under section 403(r) of the FD&C Act. The definition established
in 1994 (original definition) was linked to certain requirements in the
Nutrition Facts label at Sec. 101.9 (21 CFR 101.9) and serving size
regulations at Sec. 101.12 (21 CFR 101.12) that were in effect in
1994. The 1994 rule established parameters for use of the implied
nutrient content claim ``healthy'' or related terms (such as
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,''
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') on
the label or in the labeling of a food that is useful in creating a
diet that is consistent with dietary recommendations, if the food meets
certain nutrient conditions. Under the 1994 rule, these conditions
included specific criteria for nutrients that must be met for the food
to bear such claims. These criteria included limits on total fat,
saturated fat, cholesterol, and sodium, and minimum amounts (10% of DV)
of nutrients whose consumption is encouraged, such as vitamin A,
vitamin C, calcium, iron, protein, and dietary fiber. Under the 1994
rule, foods must meet all limits and contain the minimum amount of at
least one nutrient to encourage (NTE) to bear the ``healthy'' claim.
The required nutrient criteria varied for certain food groups (e.g.,
different criteria for seafood, game meat, and raw fruits and
vegetables). The 1994 rule also linked the claim with an explicit or
implicit claim or statement about a nutrient (e.g., ``healthy, contains
3 grams of fat'').
Nutrition science and Federal dietary guidance have evolved since
1994. Since that time, FDA has issued final rules updating the
Nutrition Facts label and serving size information for packaged foods
to reflect new scientific information. This includes the final rules
``Food Labeling: Revision of the Nutrition and Supplement Facts
Labels'' (81 FR 33742, ``NFL Final Rule''), and ``Food Labeling:
Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating
Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing
Certain Reference Amounts Customarily Consumed; Serving Size for Breath
Mints; and Technical Amendments'' (81 FR 34000, ``Serving Size Final
Rule'') which were published on May 27, 2016. These rules (codified
primarily at part 101 (21 CFR part 101)) included changes to the
nutrients that must be declared on the Nutrition Facts label. For
example, the Nutrition Facts label must now include a declaration of
the amount of added sugars in a serving of a product, based on our
conclusion that evidence regarding dietary patterns and health outcomes
supports a mandatory declaration of added sugars (Sec.
101.9(c)(1)(iii)). The updates also included changes to the DV of
certain individual nutrients to reflect changes in recommended intake
levels based on current nutrition science. The Nutrition Facts label
declaration requirements and DVs for individual nutrients significantly
inform the regulations for nutrient content claims, such as
``healthy.'' The NFL Final Rule and the Serving Size Final Rule reflect
the nutrition science in the Dietary Guidelines, other consensus
reports, national survey intake data, and research regarding consumer
use and understanding of the food label.
As the Dietary Guidelines, 2020-2025 explains, current nutrition
science focuses ``on consuming a healthy dietary pattern'' (Ref. 1).
Current nutrition science emphasizes nutrient-dense foods, such as
fruits, vegetables, and whole grains, as core elements of a healthy
dietary pattern. ``Nutrient-dense'' foods and beverages are defined as
foods and beverages that provide vitamins, minerals, and other health-
promoting components and have little or no added sugars, saturated fat,
and sodium (Ref. 1). These foods, which contain a variety of important
nutrients, work synergistically as part of a dietary pattern to help
improve health (Ref. 1). A number of these nutrient-dense foods were
not able to bear the ``healthy'' claim under the 1994 rule (e.g.,
salmon due to fat amounts). Further, the 1994 rule permitted
manufacturers to use the claim ``healthy'' on some foods that, based on
updated nutrition science and Federal dietary guidance, contain levels
of nutrients that would not help consumers maintain healthy dietary
practices (e.g., certain foods that are high in added sugars). We have
long recognized the need to update the definition for the implied
nutrient content claim ``healthy'' to be consistent with current
nutrition science and Federal dietary guidance. Consequently, in the
Federal Register of September 29, 2022 (87 FR 59168), we issued a
proposed rule to amend the definition of ``healthy'' to ensure that
foods bearing the claim are foods that may help consumers maintain
healthy dietary practices, consistent with current nutrition science
and Federal dietary guidance; in other words, nutrient-dense foods that
are foundational to a healthy dietary pattern. The preamble to the
proposed rule discussed, in some detail, the reasons why we felt it
necessary to update the definition of ``healthy'' as an implied
nutrient content claim (see 87 FR 59168 at 59169 through 59173).
When FDA first defined healthy in 1994 (59 FR 24232), we concluded
that ``the fundamental purpose of a `healthy' claim is to highlight
those foods that, based on their nutrient levels, are particularly
useful in constructing a diet that conforms to current dietary
guidelines'' (59 FR 24232 at 24233). Under this framework, which is
continued under this rule, foods that do not qualify for use of the
claim are not deemed to be ``unhealthy'' or unable to provide any
nutritional benefits to consumers. Nor does the healthy definition, as
established in this rule, represent a determination by FDA that
consumers should only choose foods that qualify for the ``healthy''
claim or completely avoid choosing foods that do not qualify for the
``healthy'' claim. The current Dietary Guidelines, 2020-2025 (Ref. 1)
focuses on the importance of a healthy dietary pattern as a whole and
its role in promoting health, reducing risk of chronic diseases, and
meeting nutrient needs. Although nearly all foods can be incorporated
into a healthy dietary pattern to some extent, current nutrition
science emphasizes nutrient-dense foods, such as fruits, vegetables,
and whole grains, as core elements of a healthy dietary pattern (Ref.
1). Moreover, foods that meet the requirements for ``healthy'' as
defined in this rule are foods that, because of their overall nutrition
profiles, can be the ``foundation'' or ``building blocks'' of a healthy
dietary pattern recommended by the Dietary Guidelines.
Foods that do not meet the requirements defined in this rule to
bear the ``healthy'' claim could, however, have beneficial nutritional
attributes and these nutritional attributes can be communicated to
consumers in many different ways. For example, use of other nutrient
content claims, such as ``low'' (e.g., ``low saturated fat'' in Sec.
101.62(c) (21 CFR 101.62(c))) or ``high'' (Sec. 101.54(b) (21 CFR
101.54(b))) can inform consumers interested in intake of specific
nutrients. In addition, a food label can include health claims, which
are different than nutrient content claims in that they show how a food
or food component may reduce the risk of a disease or health-related
condition. Other claims (e.g., structure/
[[Page 106071]]
function claims) can describe, for example, the role of a nutrient
intended to affect the normal structure or function of the body.
Additionally, dietary guidance statements are a type of voluntary
labeling statement that can be used on labels that represent or suggest
that an individual food or food group may contribute to or help
maintain a nutritious dietary pattern. Dietary guidance statements
provide manufacturers with a broad range of messages beyond
characterizing the nutrient content of the food (compared with nutrient
content claims such as ``healthy'') and can communicate to consumers
that a food or food group may contribute to or help maintain a
nutritious dietary pattern. Different nutrition labeling claims
communicate different meanings to consumers, and there are different
criteria for their use. However, certain statements may be considered
more than one type of claim, depending on the context in which they are
used and taken together with the labels or labeling as a whole. As
such, that a food may qualify for another type of claim does not
automatically make the food eligible for the ``healthy'' claim, just as
that a food qualifies for the ``healthy'' claim does not mean a food
will meet the requirements for other claims. The criteria for each of
the different claims must be met to use that specific claim and
manufacturers are free to use any applicable claims for which they
qualify and make truthful and non-misleading statements on food labels
or labeling.
B. Summary of Comments to the Proposed Rule
We received approximately 400 comments on the proposed rule, each
containing one or more comments on one or more provisions of the rule.
We received comments from industry; trade organizations; consulting
firms; law firms; academia; public health organizations; public
advocacy groups; consumers; consumer groups; Congress, State, and local
Governments; and other organizations. In section V. (``Comments on the
Proposed Rule and FDA Response''), we summarize these comments, respond
to them, and explain any revisions we made to the proposed rule. The
topics addressed most frequently in the comments include:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> Other comments recommend changes, including both higher or
lower limits, to the nutrient limits for added sugars, saturated fat,
and sodium.
<bullet> 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:
<bullet> The rule applies the ``healthy'' criteria to individual
foods with a RACC of 50 g or less or 3 Tbsp or less on a per 50 g basis
instead of a per RACC basis (Sec. 101.65(d)(3)(ii)(A) and (B)). This
results in foods consumed in small amounts that are recommended for
healthy dietary patterns qualifying for the claim.
<bullet> The rule expands the proposed exemption for raw, whole
fruits and vegetables to provide that an individual food or mixed
product that is comprised of one or more of the foods encouraged by the
Dietary Guidelines, with no other added ingredients except for water,
automatically qualifies for the ``healthy'' claim without meeting the
specified criteria because of its nutrient profile and total
contribution to an overall healthy diet. Such foods are vegetables;
fruits; whole grains; fat-free and low-fat dairy; and lean meat,
seafood, eggs, beans, peas, lentils, nuts, and seeds (Sec.
101.65(d)(3)(i)).
<bullet> The rule makes several changes to the FGE criteria from
what we proposed, including:
[cir] The FGE for dairy is \2/3\ c-eq instead of \3/4\ c-eq.
[cir] For combination foods (mixed products, main dishes, and
meals), the rule provides additional flexibility in the proportions
required for FGEs. For mixed products, the proposed rule would have
required \1/2\ FGEs from each of the two food groups. The final rule
requires that each food group component should have no less than \1/4\
FGE and that the combined amount of two or more different groups be
equal to one total FGE (e.g., \1/4\ FGE from one food group and \3/4\
FGE from the second food group) (Sec. 101.65(d)(3)(iii)). For main
dish products and meal products, the proposed rule would have required
exactly 1 FGE each of two or three different food groups, respectively.
The final rule requires that each food group component have no less
than \1/2\ FGE to comprise the total of 2 FGEs for main dish products
and 3 FGEs for meal products (Sec. 101.65(d)(3)(iv)-(v)). This
increased flexibility for FGE requirements will result in more
products, such as plant-based patties, being able to meet the FGE
requirements for combination foods while still containing meaningful
amounts of the different food groups.
[[Page 106072]]
[cir] Vegetable and fruit powders that are produced by drying whole
vegetables and fruits and grinding into powder form have similar
nutrient content to whole vegetables and fruits, and they may be
considered in calculation of the vegetable and fruit FGEs for the
``healthy'' claim.
<bullet> The rule makes a number of changes to the nutrient to
limit criteria from what we proposed, including:
[cir] The rule provides more flexibility for sodium in mixed
products by increasing the limit from <=10% DV to <=15% DV per RACC
(Sec. 101.65(d)(3)(iii)).
[cir] The rule provides more flexibility for added sugars in whole
grain products by increasing the limit from <=5% DV to <=10% DV for the
grains group (Sec. 101.65(d)(3)(ii)).
[cir] The rule finalizes an added sugars limit for individual
fruits, vegetables, and protein foods of <=2% of the DV in
consideration of the addition of small amounts of added sugars through
seasonings and recipes, as well as for the functional attributes of
sugars (Sec. 101.65(d)(3)(ii)).
[cir] The rule excludes the inherent saturated fat in seafood from
the saturated fat limit for seafood products and lowers the saturated
fat limit for seafood products to <=5% DV, to provide more flexibility
for seafood, which has a fat profile that is predominantly beneficial
unsaturated fats but has amounts of naturally occurring saturated fat
that can vary across and within different types of seafood (Sec.
101.65(d)(3)(ii)). This approach is consistent with the proposed
approach for nut and seed products.
[cir] For combination foods (mixed products, main dishes, and
meals), the rule streamlines the NTL criteria so that there is one
limit each for saturated fat, sodium, and added sugars for mixed
products, for main dishes, and for meals (i.e., limits do not vary
based on food groups within each category) (Sec. 101.65(d)(3)(iii)-
(v)).
<bullet> The rule expands the exemption for plain and plain,
carbonated water to include all water, tea, and coffee with less than 5
calories per RACC and per labeled serving (Sec. 101.65(d)(3)(vi)). The
exemption includes carbonated or noncarbonated water, coffee, and tea,
containing non-caloric ingredients such as flavors, no- or low-calorie
sweeteners, vitamins, and minerals.
IV. Legal Authority
We are issuing this rule to update the definition of the implied
nutrient content claim ``healthy'' consistent with our authority in
sections 201(n), 403(a), 403(r), and 701(a) of the FD&C Act. These
sections authorize FDA to adopt regulations that prohibit labeling that
is false or misleading in that it fails to reveal facts that are
material in light of the representations that are made with respect to
consequences that may result from consuming the food or uses terms to
characterize the level of any nutrient in a food that has not been
defined by regulation by FDA.
Congress passed the Nutrition Labeling and Education Act (NLEA) of
1990 (Pub. L. 101-535), with three basic objectives: (1) to make
available nutrition information that can help consumers in selecting
foods that can lead to healthier diets; (2) to eliminate consumer
confusion by establishing definitions for nutrient content claims that
are consistent with the terms defined by the Secretary of HHS; and (3)
to encourage product innovation through the development and marketing
of nutritionally improved foods (58 FR 2302, January 6, 1993). The NLEA
created section 403(r)(1)(A) of the FD&C Act, which provides
specifications for a claim made in the label or labeling of the food
which expressly or by implication characterizes the level of any
nutrient which is of the type required by section 403(q)(1) or (2) of
the FD&C Act to be in the label or labeling of the food. The statute
permits the use of these label and labeling claims that expressly or by
implication characterize the level of any nutrient in a food, but only
if the claims are made in accordance with FDA's authorizing regulations
(section 403(r)(1)(A) and (r)(2)(A) of the FD&C Act). Such claims are
referred to as ``nutrient content claims.''
Nutrient content claims can either be claims that expressly
characterize the level of a nutrient (express claims, such as ``low
fat'') or claims that by implication characterize the level of any
nutrient (implied claims, like the ``healthy'' claim or ``high in oat
bran''). Nutrient content claims are typically based per RACC. This
allows nutrient content claims on foods to be considered consistently
across products and product sizes. In rulemaking to implement section
403(r)(1)(A) and 403(r)(2) of the FD&C Act shortly after the enactment
of the NLEA, we determined that a claim that states that a food,
because of its nutrient content, may be useful in maintaining healthy
dietary practices is a claim that characterizes the levels of nutrients
in a food (``Food Labeling: Nutrient Content Claims, General
Principles, Petitions, Definition of Terms,'' 58 FR 2302 at 2374 to
2375, January 6, 1993). That rulemaking resulted in regulations
defining ``implied nutrient content claims'' as including claims that
imply that a food, because of its nutrient content, may help consumers
maintain healthy dietary practices. As the preamble explained, ``[t]he
claims are essentially saying that the levels of nutrients in the food
are such that the food will contribute to good health'' (58 FR 2302 at
2375).
FDA issued another regulation in 1994, in which we defined
``healthy'' when the term is used as an implied nutrient content claim
(59 FR 24232, May 10, 1994). The preamble to the 1994 final rule
explained that the statute requires that FDA define terms by regulation
before they are used as nutritional claims in food labeling; more
specifically, under the terms of section 403(r)(1)(A) and 403(r)(2) of
the FD&C Act, a nutrient content claim would misbrand a food unless it
is made in accordance with a definition of the Secretary of HHS (and,
by delegation, FDA) or with one of the other provisions in section
403(r)(2) of the FD&C Act (59 FR 24232 at 24234). The preamble
explained that FDA had already determined that, when used in the
nutritional labeling context, the term ``healthy'' is making an implied
claim about the levels of the nutrients in the food; that is, that
these levels are such that the food would be useful in achieving a
total diet that conforms to current dietary recommendations (56 FR
60421 at 60423, November 27, 1991). Accordingly, FDA established a
definition for ``healthy'' when it is used in a nutritional context.
This rulemaking updates the definition of ``healthy'' when used as
an implied nutrient content claim, based on current nutrition science
and Federal dietary guidance. The updates also reflect the science
underlying the changes made to the Nutrition Facts label in the 2016
update to that labeling requirement. As explained in section III.
(``Background''), our updated criteria for ``healthy'' incorporate both
food group and NTL requirements. These changes are intended to ensure
that foods bearing the implied nutrient content claim ``healthy'' are
nutrient-dense foods that may help consumers maintain healthy dietary
practices, based on current nutrition science and Federal dietary
guidance. The fundamental purpose of this rulemaking furthers the
Congressional objectives underlying the NLEA of providing nutrition
information to consumers to help in selecting foods that can lead to
healthier diets and reducing consumer confusion potentially caused by
the use of inconsistent definitions for nutrient content claims.
The revised definition of ``healthy'' is consistent with the
framework
[[Page 106073]]
established by the statute and regulations as informed by current
science. The statutory language describes nutrient content claims as
claims in the label or labeling of a food that expressly or by
implication characterize the level of any nutrient in a food (section
403(r)(1)(A) of the FD&C Act). FDA regulations define ``implied
nutrient content claims,'' in part, as claims that imply that a food,
because of its nutrient content, may help consumers maintain healthy
dietary practices. The statute's reference to characterizing the level
of any nutrient and the regulation's reference to maintaining healthy
dietary practices incorporate a scientific component because both the
characterization and the assessment of healthy dietary practices
involve an evaluation of the impact of diet on health. As science
evolves over time, the understanding of how nutrient levels should be
characterized and appropriate measures for maintaining healthy dietary
practices may also evolve. Thus, it is appropriate and consistent with
the regulatory framework for FDA to update definitions related to
implied nutrient content claims based on current science.
The term ``healthy'' can be an implied nutrient content claim
because it suggests that the food, because of its nutrient content, may
help consumers maintain healthy dietary practices. The 1994 definition
of the claim discussed levels for nine different individual nutrients:
fat, saturated fat, cholesterol, vitamin A, vitamin C, calcium, iron,
protein, and fiber (Sec. 101.65(d)(2)(i)). As discussed elsewhere in
this document, in recent years the Dietary Guidelines have shifted to
recommending healthy dietary patterns and the consumption of food
groups in certain quantities to achieve adequate nutrient intake, based
on the understanding that each food group contributes an array of
important nutrients to the diet (Dietary Guidelines, 2020-2025). The
Dietary Guidelines, 2020-2025 reflects the current scientific
understanding that nutrients are not consumed in isolation and focuses
its recommendations on consuming a variety of nutrient-dense foods,
across all food groups, as part of a healthy dietary pattern.
Specifically, the Dietary Guidelines, 2020-2025 states that because
foods provide an array of nutrients and other components that have
health benefits, nutritional needs should be met primarily through
eating a variety of nutrient-dense foods. Additionally, the Dietary
Guidelines, 2020-2025 recommends increasing intakes of certain food
groups and subgroups to shift intakes of underconsumed dietary
components closer to recommendations.
As we have long explained, the ``healthy'' claim thus
``characterizes the level of [some] nutrient[s] in a food'' by
implicitly stating that the food contains nutrients at levels or in
combinations that help consumers maintain healthy dietary practices.
Our 1994 definition sought to ensure that the use of that claim would
help consumers who choose to maintain such dietary practices, would not
be misleading, and would reduce consumer confusion. That definition did
so by tying the use of the claim to circumstances in which the claim
accorded with then-accepted scientific and medical understandings. As
the underlying science has developed--in ways reflected in the Dietary
Guidelines, 2020-2025--the definition of the claim must be updated to
ensure that our regulation continues to serve its original functions.
The final rule's definition of ``healthy'' includes food groups
that provide a number of different nutrients. It thus reflects the
conclusion that the use of the term ``implicitly'' characterizes the
overall nutrient content of the food, rather than focusing on one
individual nutrient in isolation, as with an express nutrient content
claim. Each food group that is included in the food group requirement
for the updated definition of the ``healthy'' claim represents the
inclusion of multiple important nutrients. The use of food groups
better accounts for how all these nutrients contribute, and may work
synergistically, to create a healthy dietary pattern and improve health
outcomes. It thus better accounts for how the use of the ``healthy''
claim implicitly characterizes the level of nutrients in a food--as
containing nutrients in sufficient levels and combinations that
contribute to healthy dietary patterns, which can lead to better health
outcomes. By requiring products to contain a certain amount of a food
group, the final rule will help ensure foods bearing the ``healthy''
claim contain a variety of important beneficial nutrients and,
therefore, help Americans meet recommended nutrient intakes and
maintain healthy dietary patterns.
In addition to section 403(r)(2) of the FD&C Act, we are issuing
this rule under section 701(a) of the FD&C Act, which states that we
may issue regulations for the efficient enforcement of the FD&C Act and
has been interpreted to apply to ``effectuate a congressional objective
expressed elsewhere in the Act'' (Association of American Physicians
and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing
Pharm. Mfrs. Ass'n. v. FDA, 484 F. Sup. 1179, 1183 (D. Del. 1980)).
We are also relying on our authority under sections 403(r), 403(a),
201(n), and 701(a) of the FD&C Act, to finalize records requirements
designed to ensure that the use of the ``healthy'' claim is accurate,
truthful, and not misleading, based on information known only to the
manufacturer, and to facilitate efficient and effective action to
enforce the requirements when necessary. Our authority to establish
records requirements has been upheld under other provisions of the FD&C
Act where FDA has found such records to be necessary (National
Confectioners Assoc. v. Califano, 569 F.2d 690, 693-94 (D.C. Cir.
1978)). The recordkeeping applies only to foods voluntarily bearing the
``healthy'' claim for which an adequate analytical method to determine
FGE is not available or the amount cannot be discerned from the label
alone. The records will allow us to verify that the product meets the
requirements to bear the claim and that use of the nutrient content
claim ``healthy'' is truthful and not misleading. Thus, the records
requirements will help in the efficient enforcement of the FD&C Act
(see discussion in section V.I (``Records Requirements'') for more
information).
The authority granted to FDA under sections 701(a), 403(r),
403(a)(1), and 201(n) of the FD&C Act not only includes authority to
establish records requirements, but also includes access to such
records. Without access to such records, FDA would not know whether the
food meets the proposed requirements to bear the ``healthy'' claim
consistent with section 403(r) of the FD&C Act, and whether the use of
the claim is truthful and not misleading under sections 403(a)(1) and
201(n) of the FD&C Act. The introduction or delivery for introduction
into interstate commerce of a misbranded food is a prohibited act under
section 301(a) of the FD&C Act (21 U.S.C. 331(a)). Thus, to determine
whether a food that is voluntarily bearing a ``healthy'' nutrient
content claim is misbranded and the manufacturer has committed a
prohibited act, we must have access to the manufacturer's records that
we are requiring be kept under Sec. 101.65(d)(4). Failure to make and
keep records and provide the records to FDA, as described in Sec.
101.65(d)(4), would result in the food bearing the ``healthy'' claim
being misbranded under sections 403(r) and 403(a)(1) of the FD&C Act.
[[Page 106074]]
V. Comments on the Proposed Rule and FDA Response
A. Introduction
We received approximately 400 comments on the proposed rule. We
received comments from consumers; consumer groups; academia; trade
organizations; industry (e.g., food manufacturers); public health
organizations; public advocacy groups; Congress, State, and local
government agencies; and other organizations. In the remainder of this
section, we summarize these comments, respond to them, and explain any
revisions we made to the proposed rule. Where we did not receive
comments and do not have additional discussion in this final rule, we
finalized the proposed provisions without change.
We have numbered each comment to help distinguish between different
comments. We have grouped similar comments together under the same
number, and, in some cases, we have separated different issues
discussed in the same comment and designated them as distinct comments
for purposes of our responses. The number assigned to each comment or
comment topic is purely for organizational purposes and does not
signify the comment's value, importance, or the order in which comments
were received.
B. General Comments
Many comments make general remarks supporting or opposing the
proposed rule without focusing on a particular proposed provision.
(Comment 1) The majority of the comments express general support
for updating the ``healthy'' implied nutrient content claim to make it
consistent with current nutrition science and Federal dietary guidance,
including the Dietary Guidelines, 2020-2025, noting the claim has not
been updated since the 1990s. Numerous comments note that the proposed
rule would help consumers make better, healthier choices for purchasing
and consuming food, generally improve the nutritional knowledge of the
average U.S. consumer, and give consumers information that could help
combat the high rate of obesity and diet related chronic diseases and
illnesses in the United States.
(Response 1) We agree with the comments that support updating the
``healthy'' implied nutrient content claim. Nutrition science has
evolved since the 1990s when FDA first established a definition for the
implied nutrient content claim ``healthy,'' and the purpose of this
rule is to update the definition to be consistent with current
nutrition science and Federal dietary guidance, such as the Dietary
Guidelines, 2020-2025, to help ensure that consumers have access to
more complete, accurate, and up-to-date information in the labeling of
human food products. As more fully discussed in section III.
(``Background''), the fundamental purpose of a ``healthy'' claim is to
highlight those foods that, based on their nutrient levels, are
particularly useful in constructing a diet that is consistent with
current dietary guidelines. The current Dietary Guidelines, 2020-2025
focuses on the importance of a healthy dietary pattern as a whole and
its role in promoting health, reducing risk of chronic diseases, and
meeting nutrient needs (Ref. 1). Therefore, foods that qualify for
``healthy'' are those foods that are particularly useful in helping
consumers with creating healthy dietary patterns. As discussed, with
this framework, we emphasize that foods that do not qualify for use of
the claim are not necessarily ``unhealthy'' or unable to provide any
nutritional benefits to consumers. Foods that meet the requirements for
the ``healthy'' claim are foods that, because of their overall
nutrition profiles, can be a ``foundation'' for a healthy dietary
pattern recommended by the Dietary Guidelines, 2020-2025. Foods that do
not meet the requirements could, however, have attributes that are
beneficial. As more fully discussed above in section III.
(``Background''), these beneficial attributes can be communicated to
consumers in other ways. We reiterate that an inability to meet the
requirements for use of the claim ``healthy'' does not necessarily make
a food unhealthy and that manufacturers can communicate the nutritional
qualities of their foods through other applicable label claims and any
truthful and non-misleading statements they want to include.
(Comment 2) Some comments recommend the term ``healthy'' continue
to evolve as science around nutrition changes and ask us to clarify our
intentions to update the claim in the future, as needed.
(Response 2) Although the Dietary Guidelines are published every 5
years to reflect current nutrition science, and some of its specific
recommendations have evolved as scientific knowledge has grown, many of
its foundational recommendations have remained consistent over time
(e.g., recommending increased consumption of fruits, vegetables, and
whole grains, and diets low in saturated fat and sodium). As discussed
in the proposed rule (87 FR 59168 at 59170), advancements in nutrition
science have provided a greater understanding of, and focus on, the
importance of healthy dietary patterns, and how dietary components act
synergistically to affect health. The Dietary Guidelines, 2020-2025 has
a particular focus on the importance of dietary patterns as a whole,
with recommendations to help Americans make choices from across and
within all food groups within calorie needs to add up to an overall
healthy dietary pattern (Ref. 1). The Dietary Guidelines, 2020-2025
also includes recommendations to limit daily intake of added sugars,
saturated fat, and sodium, and emphasizes ``shifts,'' or replacement of
less healthy food choices with nutrient-dense foods, as methods for
consumers to achieve a healthy dietary pattern. The scientific evidence
discussed in the Dietary Guidelines, 2020-2025 and the Scientific
Report of the 2020 Dietary Guidelines Advisory Committee (2020 DGAC
report), and the recommendations based on that nutrition science, have
informed this rulemaking and are the primary basis for the criteria
that we have established for the ``healthy'' nutrient content claim.
While there has been consistency in many of the recommendations in
Federal dietary guidelines and the underlying nutrition science on
which they are based, we intend to remain aligned with the most current
nutrition science reflected in Federal dietary guidelines and will
update our regulations and policies, as appropriate. However, we note
that the updated definition of ``healthy'' is designed to be flexible
and to accommodate possible changes in updated recommendations, as
discussed further below in this section. For example, instead of tying
the nutrient limits to absolute values, the criteria are provided as
percentages of the DV.
(Comment 3) Some comments ask FDA to clarify that our work to
update the ``healthy'' definition does not signal that other foods do
not have a role to play in a healthy dietary pattern or something
broader, such as whether a food is ``good'' or ``bad'' or ``some other
broader policy recommendation.'' Some comments assert that allowing
some foods to be labeled as ``healthy'' could lead consumers to infer
all other foods are unhealthy, even if such foods have beneficial
components, which could limit options for low-income and vulnerable
populations.
Several comments assert that ``healthy'' diets vary across
cultures, ages, and disease states and suggest that, for example, a
healthy diet for an individual recovering from an eating
[[Page 106075]]
disorder is vastly different from a healthy diet for someone who has
heart failure. The comments argue that allowing foods to be labeled as
``healthy'' implies that foods without those labels are ``unhealthy''
and could exacerbate eating disorders and possibly trigger relapse or
otherwise prevent recovery. Some comments claim that FDA is incorrectly
indicating that ``healthy'' is the same for everyone and suggest that
our focus should instead be on giving people the tools to evaluate the
specific nutrients that are in food and that we should consider
removing the ``healthy'' claim altogether and refocus labeling efforts
on clear and concise labeling that is sensitive to multiple cultures,
disease states, and ages.
(Response 3) In this rule, we are updating the criteria for the
``healthy'' nutrient content claim so that it aligns with current
nutrition science and Federal dietary guidance. The fundamental purpose
of a ``healthy'' claim is to highlight those foods that, based on their
nutrient levels, are particularly useful in creating a diet that is
consistent with current dietary guidelines. As discussed, with this
framework, we emphasize that foods that do not qualify for use of the
claim or do not use the claim are not necessarily ``unhealthy'' or
unable to provide any nutritional benefits to consumers. Foods that
meet the requirements for the ``healthy'' claim are foods that, because
of their overall nutrition profiles, are useful as a foundation for a
healthy dietary pattern recommended by the Dietary Guidelines, 2020-
2025. The scientific evidence that informs the Dietary Guidelines is
representative of the U.S. population, including people who are
healthy, people at risk for diet-related chronic conditions and
diseases (e.g., CVD, type 2 diabetes, and obesity), and some people who
are living with one or more of these diet-related chronic illnesses
(Ref. 1). The Dietary Guidelines, 2020-2025 states that a ``fundamental
premise of the 2020-2025 Dietary Guidelines is that nearly everyone, no
matter their health status, can benefit from shifting food and beverage
choices to better support healthy dietary patterns'' and explains that
it is essential that medical organizations and health professionals
adapt the Dietary Guidelines to meet the specific needs of their
patients (Ref. 1). For consumers who would like to evaluate the
specific nutrients that are in a food or beverage, the Nutrition Facts
label is an available tool. The comments did not provide, and we are
not aware of, evidence that a food labeled ``healthy'' for the narrow
purpose of making a voluntary nutrient content claim could adversely
impact those with eating disorders. We plan to undertake consumer
education efforts related to the ``healthy'' claim, which we expect to
include highlighting the importance of choosing a variety of nutrient-
dense foods within and across different food groups and subgroups.
(Comment 4) Some comments argue that the proposed rule would not
cause a ``significant'' change in consumer behavior or diet, warning
that a ``healthy'' claim on processed and packaged products could
discourage consumers from buying whole fruits and vegetables. However,
such comments also note that an update to the ``healthy'' definition
would make food products labeled with the claim align with current
nutrition standards and lead to more healthy products being sold. The
comments also assert that packaged food products are ``essential'' for
communities that cannot afford exclusively fresh foods, and state that
the new definition would help customers identify healthier options.
(Response 4) Nutrient content claims such as ``healthy'' are
intended to provide consumers with information to help them quickly and
easily identify foods that can be the foundation of a healthy dietary
pattern. We agree that the updated ``healthy'' claim, which focuses on
food groups and NTL, will better align with current nutrition science
and support consumers, including those who frequently purchase packaged
foods, in identifying healthier options. We disagree that the updated
healthy claim could discourage consumers from buying whole fruits and
vegetables. Both processed and packaged foods as well as fresh, whole
foods, such as fruits and vegetables will be able to qualify for the
``healthy'' claim. Foods that qualify for the healthy claim that are
not packaged can have the claim communicated to consumers through
signage and other materials in the store. Therefore, through use of the
``healthy'' claim, consumers will have additional information on foods
throughout the grocery store that can help make more informed
decisions.
(Comment 5) Some comments oppose the proposed definition of
``healthy,'' asserting that the term ``healthy'' is not easily
definable, will be used inconsistently, can quickly become outdated,
and is a subjective term that can be applied differently for different
people. Some comments assert that this change would allow food
manufacturers to incorrectly label what the comments consider unhealthy
foods as ``healthy,'' thus allowing manufacturers to mislead and
deceive consumers. Some comments oppose the rule by asserting that
government control over food labeling and promulgation of rules about
what can be called ``healthy'' is unnecessary.
(Response 5) The rule establishes updated criteria for the narrow
use of the term ``healthy'' as a voluntary nutrient content claim. As
discussed in section IV. (``Legal Authority''), Congress passed the
NLEA with three basic objectives: (1) to make available nutrition
information that can help consumers select foods that can lead to
healthier diets; (2) to eliminate consumer confusion by establishing
definitions for nutrient content claims that are consistent with the
terms defined by the Secretary of HHS; and (3) to encourage product
innovation through the development and marketing of nutritionally
improved foods. The NLEA created section 403(r)(1)(A) of the FD&C Act,
which provides specifications for a claim made in the label or labeling
of the food which expressly or by implication characterizes the level
of any nutrient which is of the type required by section 403(q)(1) or
(2) of the FD&C Act to be in the label or labeling of the food. The
statute permits the use of these label and labeling claims that
expressly or by implication characterize the level of any nutrient in a
food, but only if the claims are made in accordance with FDA's
authorizing regulations (section 403(r)(1)(A) and (r)(2)(A) of the FD&C
Act). Hence, establishing a definition of ``healthy,'' when used as a
nutrient content claim, is necessary for such claims to be lawfully
made and is partially intended to serve the very purpose these general
comments opposing the rule use to argue against it, namely, to avoid
consumer confusion and misleading claims. The fundamental purpose of
this rulemaking furthers the Congressional objectives underlying the
NLEA of providing nutrition information to consumers to help in
selecting foods that can lead to healthier diets and reducing consumer
confusion potentially caused by the use of inconsistent definitions for
nutrient content claims. Further, under section 403(r)(1)(A) and (r)(2)
of the FD&C Act, use of the ``healthy'' nutrient content claim would
misbrand a food unless it is made in accordance with the regulatory
definition we are establishing in this rule.
[[Page 106076]]
C. Food Group Equivalents
1. General Comments
(Comment 6) Numerous comments support using food groups as criteria
in the definition of the claim ``healthy,'' stating that the change
from focusing on individual nutrients better reflects the Dietary
Guidelines, ensures that more nutrient-dense foods are included in the
``healthy'' definition, increases flexibility for certain products,
avoids shifting nutrient guidelines, and is clearer to consumers. The
comments mention that use of the food group criteria will enhance the
messaging around the importance of creating healthy eating habits as
opposed to a framework that targets individual foods. Some comments
also provide that basing the ``healthy'' definition on food groups
rather than individual nutrients is more consistent with evolving
nutrition science that emphasizes dietary patterns. One comment
mentions that requiring products to meet food-based criteria may help
minimize or avoid unintended consequences of a focus solely on
individual nutrients.
Some comments oppose use of food groups as criteria in the
definition of the claim ``healthy,'' as opposed to individual
nutrients, claiming the FGEs are too complex and difficult to
calculate, that there is too much variance in nutrients within certain
food groups, and the healthfulness of foods should be based on
different individual nutrients. One comment claims that FDA has not
adequately justified the move from only considering nutrients to also
including food groups in the definition of the ``healthy'' claim.
(Response 6) We agree that the food group approach is in alignment
with the Dietary Guidelines, 2020-2025, which places an emphasis on a
healthy dietary pattern as a whole, rather than on individual nutrients
or foods in isolation. The Dietary Guidelines, 2020-2025 states that
because foods provide an array of nutrients and other components that
have health benefits, nutritional needs should be met primarily through
a variety of nutrient-dense foods. The Dietary Guidelines, 2020-2025
provides that a healthy dietary pattern consists of nutrient-dense
forms of foods and beverages, in recommended amounts, across all food
groups and recommends increasing intakes of certain food groups and
subgroups to move intakes of underconsumed dietary components closer to
recommendations.
We disagree that the FGE approach is too complex and note that
there are several currently available resources that can help with
calculation. As discussed further herein, the food groups and the FGE
amounts are based on information contained in the Dietary Guidelines,
2020-2025; as such, the Dietary Guidelines, 2020-2025 is a helpful
resource in determining the amounts of foods necessary to meet FGEs.
The USDA Food Patterns Equivalents Database (FPED) also provides
information about cup- and ounce-equivalents of different foods and
beverages to assist with calculations (Ref. 3). Additionally, FDA
recognizes the importance of time for industry to determine the FGE
amounts in their products, and we have set the rule's compliance date
as being 3 years from the rule's effective date. We intend to provide
additional resources for manufacturers to help determine FGE amounts
before the compliance date. The additional resources may include
guidance documents for industry, information on the FDA website, FAQs,
direct communications in response to questions, or online webinars.
(Comment 7) Many comments support using food groups as criteria in
the definition of the claim ``healthy,'' but ask that the rule maintain
a level of reliance on individual beneficial nutrients or include
requirements for beneficial nutrients as an alternative to ensure that
important nutrients are not missed by the rule focusing too heavily on
food groups. Some comments support the food group approach, but request
that the updated ``healthy'' criteria permit a food to qualify if it
meets both the NTL and either the food groups to encourage or the
original NTE criteria.
(Response 7) We discussed in section III. (``Background'') that the
purpose of a ``healthy'' claim is to highlight those foods that, based
on their nutrient levels, are particularly useful in creating a diet
that is consistent with current dietary guidelines. The current Dietary
Guidelines, 2020-2025 (Ref. 1) focuses on the importance of a healthy
dietary pattern as a whole and its role in promoting health, reducing
risk of chronic diseases, and meeting nutrient needs. Therefore, based
on current dietary recommendations and nutrition science, foods that
qualify for ``healthy'' are those foods that are particularly useful in
helping consumers create healthy dietary patterns. As described by the
Dietary Guidelines, 2020-2025, a healthy dietary pattern ``consists of
nutrient-dense forms of foods and beverages across all food groups, in
recommended amounts, and within calorie limits.'' The Dietary
Guidelines, 2020-2025 also describes that ``[c]ommon characteristics of
dietary patterns associated with positive health outcomes include
relatively higher intake of vegetables, fruits, legumes, whole grains,
low- or non-fat dairy, lean meats and poultry, seafood, nuts, and
unsaturated vegetable oils, and relatively lower consumption of red and
processed meats, sugar-sweetened foods and beverages, and refined
grains.'' (Ref. 1). The original definition for the ``healthy''
nutrient content claim was based solely on individual nutrients, both
minimum amounts and specific limits. This approach is inconsistent with
current nutrition science regarding healthy dietary patterns and their
effect on health and development of chronic disease. Foods that contain
certain NTE, such as certain individual vitamins, minerals, or fiber,
can be beneficial to consumers. However, highlighting those foods as
``healthy'' would not necessarily help consumers in the overall
construction of healthy dietary patterns, in which nutrient-dense foods
from across all of the recommended food groups and subgroups provide an
array of nutrients and ensure overall nutrient adequacy from the diet.
Including requirements for minimum amounts of foods from the
recommended food groups better reflects the overall nutrient content of
foods and how nutrients in the food groups and subgroups may work
together as part of a healthy dietary pattern. Thus, we decline to
include individual NTE criteria in the final rule.
(Comment 8) Some comments assert that FDA's proposed FGE is
sometimes larger than the serving size of the product itself,
particularly for products with small serving sizes that would be unable
to qualify as ``healthy'' because they could not provide an FGE per
RACC. Examples of types of foods discussed in the comments include
certain whole grain bread products, certain snack foods, natural
cheeses, and many yogurts. The comments state that these smaller RACC
products would be excluded from making ``healthy'' claims solely based
on their serving size. The comments request that FDA modify the
criteria for products with small RACCs to require a smaller
contribution to the FGEs. The comments suggest various different
modifications to the criteria, including lowering the required FGE
amounts, adjusting the criteria for the claim to incrementally increase
based on food size, and adopting a category with criteria for foods
with small RACCs.
(Response 8) In the proposed rule (87 FR 59168 at 59177), we
determined the FGEs based on the cup- and ounce-equivalents and
recommended daily food group amounts developed for the
[[Page 106077]]
Healthy U.S.-Style Dietary Pattern for ages 2 and older in the Dietary
Guidelines, 2020-2025 (Ref. 1). The proposed thresholds for the FGEs
were set so that foods that bear the claim ``healthy'' contain enough
of the food group that they could help consumers achieve the
recommended daily food group amounts. Foods that do not contain the
minimum FGE amount for their food group would not meet the requirements
and not be eligible to bear the claim. As many comments point out,
however, there are many foods that are included in the food groups
recommended by the Dietary Guidelines, and fit into healthful dietary
patterns, that are in forms whose RACCs are smaller than the minimum
FGE requirement. After evaluating nutrient-dense foods with small RACCs
across the recommended food groups and subgroups, we have determined
that many of these foods with RACCs smaller than the proposed FGEs
could qualify for use of the claim ``healthy'' if their RACC sizes were
similar to those of typical individual foods and if they met all the
other requirements for the use of the claim (Ref. 2).
FDA has previously addressed challenges related to foods with small
RACCs in its nutrition labeling regulations. For example, in the
context of eligibility for ``low'' nutrient content claims, FDA
provided different criteria for eligibility to use the ``low fat''
claim based on the RACC of the individual food (Sec. 101.62(b)(2)). In
the context of the low-fat claim, FDA applies different criteria based
on RACC size to ensure that a food does not qualify for a ``low fat''
claim solely because it is consumed in small amounts.
For the proposed ``healthy'' definition, the reverse situation is
present in that certain foods recommended for healthful dietary
patterns would be unable to meet the FGE criteria for the claim due to
being typically consumed in small amounts. Because we do not intend to
exclude foods consumed in small amounts that are recommended for
healthful dietary patterns, the final rule applies the ``healthy''
criteria to individual foods with a RACC of 50 g or less or 3 Tbsp or
less on a per 50 g basis instead of a per RACC basis (Sec.
101.65(d)(3)(ii)(B)).
In the context of the ``low fat'' claim, FDA defined small RACC
foods as ``individual foods that have a RACC of 30 g or less or 2 Tbsp
or less.'' For the purposes of the ``healthy'' claim, to most
appropriately include the variety of foods recommended by the Dietary
Guidelines for healthful dietary patterns, which was supported by our
review of food products in the current marketplace (Ref. 2), we are
defining small RACC foods as foods with a RACC of 50 g or less or 3
Tbsp or less.
This change to the criteria for small RACC foods acknowledges that
there have been a number of changes to individual RACC sizes since
nutrient content claim criteria for foods with small RACC sizes, such
as for the ``low fat'' claim (Sec. 101.62(b)(2)), were implemented. As
an example, medium weight cereals initially had a RACC size of 30 g,
which would fall under the small RACC description included in other
nutrient content claims such as the ``low fat'' claim. In 2016, FDA
updated the RACC size for medium weight cereals to 40 g (Sec.
101.12(b)). Thus, medium weight whole grain cereals are no longer
considered a food with small RACC under the nutrient content claim of
``low fat.'' If we were to define small RACCs as ``individual foods
that have a RACC of 30 g or less or 2 Tbsp or less'' for purposes of
the ``healthy'' claim, medium weight whole grain cereals would not be
considered to have a small RACC size, would have the ``healthy''
criteria applied on a per RACC basis (40 g), and would not meet the
whole grain FGEs. However, medium weight nutrient-dense whole grain
cereals, which are recommended as part of a healthy dietary pattern,
will meet the whole grain FGE criterion for the ``healthy'' claim on a
50 g basis. As demonstrated when we reviewed the current marketplace
(Ref. 2) in our data analysis, whole grain cereals are just one of many
nutrient-dense foods recommended as part of a healthy dietary pattern
that would not meet the FGE criteria on a 30 g basis but would meet
them on a 50 g basis. Therefore, to ensure that nutrient-dense foods
that are recommended for healthful dietary patterns are able to qualify
for the ``healthy'' claim, the final rule applies the ``healthy''
criteria to individual foods with a RACC of 50 g or less or 3 Tbsp or
less on a per 50 g basis instead of a per RACC basis (Sec.
101.65(d)(3)(ii)(B).
We have also made other changes that will result in more nutrient-
dense foods with serving sizes that are smaller than the proposed FGE
requirements being able to qualify for the ``healthy'' claim. For
example, we have expanded the proposed exemption for raw, whole fruits
and vegetables (see Response 9) and lowered the FGE requirement for
dairy (see Response 29). We did not receive comments that the proposed
FGE requirements were too restrictive for other food groups and
subgroups, aside from concerns regarding products with small RACC sizes
and the dairy FGE requirement. Therefore, we are finalizing the FGE
requirements as proposed for the other food groups and subgroups.
(Comment 9) Many comments support the exemption in the proposed
rule that would allow any raw, whole fruits and vegetables, including
any whose RACC size might be smaller than the fruit and vegetable FGE
requirements, to qualify for the ``healthy'' claim. Some comments note,
however, that other fruit and vegetable options, such as frozen fruits
and vegetables or chopped fruits and vegetables (without added
ingredients), would not meet the proposed automatic qualification for
raw, whole fruits and vegetables. Some comments mention that, while
fresh or raw avocados would qualify under the exemption as proposed,
frozen avocados would not. The comments request that the exemption for
raw, whole fruits and vegetables be expanded to include other forms,
such as frozen and chopped fruits and vegetables.
Some comments note that other food groups recommended by the
Dietary Guidelines also include many similar, single-ingredient foods
that align with recommendations in the guidelines but would not qualify
for the ``healthy'' claim under the proposed rule. The comments assert
that the FGE and NTL criteria are not necessary for these types of
products because they are nutrient-dense foods encouraged by the
Dietary Guidelines. The comments request that we expand the exemption
for raw, whole fruits and vegetables to other single-ingredient
nutrient-dense foods recommended by the Dietary Guidelines or include
an additional category for nutrient-dense whole foods recommended by
the Dietary Guidelines to ensure that these types of foods can also
qualify for the ``healthy'' claim without needing to meet the FGE and
NTL criteria.
(Response 9) We do not intend to exclude nutrient-dense single-
ingredient foods that are foods encouraged by the Dietary Guidelines
from qualifying for the updated ``healthy'' definition. We agree that
it is not necessary for such foods to meet additional criteria because
they are nutrient-dense foods encouraged by the Dietary Guidelines that
can help consumers maintain healthy dietary practices by serving as a
foundation for a healthy dietary pattern. Therefore, we have revised
the rule to expand the exemption for raw, whole fruits and vegetables
to include individual foods or mixed products that are comprised of one
or more of the following nutrient-dense foods encouraged by the Dietary
Guidelines (for adults and children 2 years of age and older), with no
other added
[[Page 106078]]
ingredients except for water: vegetables; fruits; whole grains; fat-
free and low-fat dairy; and lean game meat, seafood, eggs, beans, peas,
lentils, nuts, and seeds (Sec. 101.65(d)(3)(i)). Individual foods and
mixed products that contain these nutrient-dense foods encouraged by
the Dietary Guidelines and do not contain any added ingredients,
besides water, will automatically qualify for the ``healthy'' claim
because of their nutrient profile and positive contribution to an
overall healthy diet. Such products do not need to meet the FGE and NTL
requirements for individual foods or mixed foods. For example, foods
such as fish and lean game meats, skim milk, brown rice, and the many
other single-ingredient nutrient-dense foods encouraged by the Dietary
Guidelines can use the ``healthy'' nutrient content claim without
having to meet the FGE and NTL requirements.
For similar reasons to those discussed above, we are also expanding
the exemption so that it will not be limited to ``raw, whole'' versions
of foods encouraged by the Dietary Guidelines, but rather will include
other forms of these foods, including a variety of shelf-stable and/or
economical forms of foods. For example, frozen or sliced fruits and
vegetables, 100% whole grain flours, dried beans, peas, and lentils,
frozen seafood, chopped nuts, and certain nut butters (i.e., only
containing nuts), with no added ingredients other than water,
automatically qualify without needing to meet the FGE and nutrient to
limit requirements. Additionally, as a result of the expansion of this
exemption, single-ingredient foods encouraged by the Dietary Guidelines
that have small RACC sizes (e.g., frozen avocado pieces) will now
qualify even if their RACCs are smaller than the FGE amounts for their
respective food groups or subgroups.
Certain mixed products are also eligible for the exemption. A mixed
product that contains multiple single-ingredient foods encouraged by
the Dietary Guidelines (without additional ingredients besides water)
but does not meet the FGE requirements for a mixed product to qualify
for ``healthy'' (i.e., contain 1 total FGE) will fall under the
expanded exemption and will automatically qualify for the claim (Sec.
101.65(d)(3)(i)). We have determined that these types of products
(i.e., mixed products that contain only nutrient-dense foods that are
encouraged by the Dietary Guidelines without added ingredients besides
water) can also serve as part of a foundation for a healthy dietary
pattern because of their nutrient profile and positive contribution to
an overall healthy diet. Many of these types of products, regardless of
whether they are individual foods or mixed products, would also meet
the FGE and NTL criteria for individual foods or mixed products;
however, this exemption allows manufacturers to more easily determine
and verify compliance with the updated ``healthy'' criteria,
particularly for mixed products. For example, a product that contains
two ingredients that are each a food encouraged by the Dietary
Guidelines--such as a frozen mix of a vegetable and a whole grain, or a
blend of 100% juices that contains 80% fruit juice and 20% vegetable
juice--and does not contain additional ingredients besides water, will
automatically qualify under the expanded exemption in Sec.
101.65(d)(3)(i). We are finalizing the expanded exemption under Sec.
101.65(d)(3)(i) as: an individual food or mixed product that is
comprised of one or more of the following foods that are the foundation
of a healthy dietary pattern, with no other added ingredients except
for water: (1) vegetable; (2) fruit; (3) whole grains; (4) fat-free and
low-fat dairy; and (5) lean meat, seafood, eggs, beans, peas, lentils,
nuts, and seeds. Additionally, because the standard information
required on the food label, such as the list of ingredients for such a
product, provides sufficient information to verify that the food meets
the ``healthy'' criteria, records will not be required to demonstrate
compliance with the FGE requirements for products that qualify for the
automatic exemption in Sec. 101.65(d)(3)(i) and (d)(4).
We are not expanding the exemption to main dishes or meals because
those products serve different roles in the diet. Main dish products,
defined by our regulations at Sec. 101.13(m), are larger in size
(weighing at least 6 oz per labeled serving) than individual foods and
mixed products, and are intended to make a major contribution to a meal
(i.e., contain most of the components of a meal). A main dish product
might include, for example, a frozen entr[eacute]e that is intended to
be eaten with additional items to form a full meal. Because of their
size and the larger contribution that they make to the overall diet, we
are requiring in Sec. 101.65(d)(iv) that main dish products contain at
least two total FGEs per labeled serving with a minimum of a \1/2\ FGE
for each of the two food groups, and that they meet NTL criteria (see
Section V.E ``Combination Foods'' for further discussion of
requirements for mixed products, main dishes, and meals). Meal
products, defined at Sec. 101.13(l), are larger in size (weighing at
least 10 oz per labeled serving) than main dish products and are
intended to provide all food for a single eating occasion (i.e., a
complete meal). An example of a meal is a frozen dinner that includes
an entr[eacute]e, vegetable side, and dessert. Because of their size
and the larger contribution that they make to the overall diet, we are
requiring in Sec. 101.65(d)(v) that meal products contain at least
three total FGEs per labeled serving with a minimum of a \1/2\ FGE for
each of the three food groups. It is important that main dishes and
meals contain a minimum amount of different food groups (i.e., meet the
FGE criteria) because their size and larger contribution in the diet
means that it is particularly important for them to contain an array of
nutrients and to help consumers achieve the recommended daily food
group amounts and meet nutritional needs, and therefore we are not
including main dishes and meals in the expanded exemption.
For simplicity, throughout the rule we will refer to this exemption
as the ``single-ingredient exemption'' and will generally refer to
these nutrient-dense foods that are encouraged by the Dietary
Guidelines with no added ingredients, except for water, as ``single-
ingredient foods encouraged by the Dietary Guidelines.'' We again note,
however, that these single-ingredient foods encouraged by the Dietary
Guidelines and the single-ingredient exemption, also include individual
foods and mixed products that contain multiple single-ingredient foods
with no added ingredients, except for water (e.g., a frozen mix of a
vegetable and a whole grain, or a blend of 100% juices that contains
80% fruit juice and 20% vegetable juice).
(Comment 10) Some comments also recommend that herbs and spices be
able to qualify for the ``healthy'' claim. These comments assert that
herbs and spices can reduce consumption of added sugars, sodium, and
saturated fat by making nutrient-dense foods more palatable without
adding calories. Additionally, the comments state that herbs and spices
increase the consumption of nutrient-dense foods such as vegetables,
fruits, and healthy grains. Some comments assert that spices meet the
definition of vegetable products, but provide that given their small
RACC, spices would not be able to meet the proposed FGE criteria.
(Response 10) We agree that herbs and spices can play an important
role in the diet by replacing seasonings and ingredients that
contribute sodium, saturated fat, and added sugars to the diet. They
can also help increase the palatability of nutrient-dense foods.
However, because of their primary use
[[Page 106079]]
as a flavoring for foods, they are typically consumed in such small
quantities that they generally do not contribute a meaningful amount of
nutrients to the diet. The Dietary Guidelines, 2020-2025 mentions that
spices and herbs can help flavor foods when reducing added sugars,
saturated fat, and sodium, and that they can also contribute to the
enjoyment of nutrient-dense foods (Ref. 1). Some herbs are included as
examples in the vegetable food group in the Dietary Guidelines, 2020-
2025 (e.g., cilantro, basil, and chives). Foods or ingredients that are
considered to be part of the vegetable food group can also contribute
toward the FGE requirement for vegetables in different forms, such as
dried forms (see Response 44).
(Comment 11) Some comments suggest that FDA allow foods with small
RACCs to satisfy their FGE requirement by having a component from a
recommended food group as the first ingredient on the ingredient
declaration. The comments suggest this ``first ingredient'' approach
both for foods with small RACCs and as an alternative to the FGE
requirement, not limited to foods with small RACCs. In the ``first
ingredient'' approach, there would be no absolute amount of a food
group required; the approach would require only that the component from
a qualifying food group would be the ingredient of the greatest weight
in a food.
(Response 11) We decline to adopt the ``first ingredient'' approach
suggested by the comments. The regulations regarding ingredient
declaration require only that ingredients be listed in descending order
of predominance by weight (21 CFR 101.4(a)). A descending order by
weight does not, however, provide any indication of a significant or
meaningful amount of an ingredient. Being listed first in the
ingredient declaration only indicates that a food has proportionally
more of that ingredient compared to each of the other ingredients
individually. For example, a food could contain 10 different
ingredients, and, although the first ingredient may weigh more than
each of the other nine ingredients individually, the total sum of the
other nine ingredients could proportionally outweigh the first
ingredient. The overall food in that case would not be likely to have a
significant amount of the first ingredient from a recommended food
group and therefore would not meaningfully contribute to the
recommended daily food group amounts. Therefore, using the first
ingredient in an ingredient list to determine FGEs would not be a
reliable way to help consumers identify foods that can help them meet
recommended food group amounts, nor would it effectively address
challenges related to the qualification of foods with small RACCs. As
discussed in Response 8, the rule includes criteria specific to small
RACC foods.
(Comment 12) Many comments request that FDA provide more guidance
on what counts as an FGE and how to calculate the FGE contribution of a
food. The comments note that the proposed FGE amounts are in volume,
and that the volume of a food will vary considerably based on the form
of the food. Some comments ask that FDA provide a standard methodology,
calculator, and/or database that manufacturers could use to determine
FGEs for their products.
(Response 12) We determined FGE amounts based on the cup- and
ounce-equivalents developed for the Healthy U.S.-Style Dietary Pattern
for ages 2 and older in the Dietary Guidelines, 2020-2025 (Ref. 1). The
Dietary Guidelines, 2020-2025 provides information on the many types of
foods that are contained in each food group in the food patterns (see
Ref. 1, Appendix A3-2, footnote b) and descriptions of how much of
those foods are needed to meet a cup- or ounce-equivalent (see Ref. 1,
Appendix A3-2, footnote c). Additionally, there are other resources
available, such as the FPED, which provides further information about
cup- and ounce-equivalents of different foods and beverages (Ref. 3).
FDA understands that, depending on the type and form of an individual
food, manufacturers may benefit from additional information on how to
determine the amount necessary to meet the FGE amounts required for
their foods to be eligible for the ``healthy'' claim. The final rule
sets a compliance date that is 3 years from the effective date, and we
intend to provide additional resources to help manufacturers comply
with the final rule before the end of the compliance period. The
additional resources may take the form of guidance documents for
industry, information on the FDA website, FAQs, direct communications
in response to questions, or online webinars, as discussed in Response
6.
(Comment 13) Many comments request that FDA make clear that the
list we provided for FGEs in the preamble to the proposed rule is not
exhaustive.
(Response 13) The marketplace for food products is wide in scope
and continually evolving and therefore cannot be comprehensively
covered by the examples of FGEs described in this rule. Thus, the list
of examples of FGEs we provided in the proposed rule and in the final
rule is not an exhaustive list.
2. FGEs Based on Four Eating Occasions Per Day
(Comment 14) Some comments express concern with the assumption in
the proposed rule that the typical American dietary pattern consists of
three meals and one snack per day (i.e., four eating occasions). The
comments assert that the dietary habits of Americans have shifted over
the past several years from a primarily meal-based diet to one that
includes more snacking or ``ready to eat'' meals. The comments suggest
that FGEs should not be based on a consumption pattern of four eating
occasions per day. Another comment notes that the recommendations in
the Dietary Guidelines, 2020-2025 were based on the assumption that
Americans consume three meals per day and two snacks.
Some comments question the equal division among the four eating
occasions. For example, some comments suggest that snacks should be
weighed differently than meals due to size. One comment recommends that
meals carry three times the ounce equivalent (oz-eq) as a snack for the
nutrient recommended daily allowance.
(Response 14) Our review of consumption patterns indicates that the
typical American dietary pattern consists of three meals and one snack
per day, i.e., four eating occasions (not including beverage-only
eating occasions) (Ref. 2). These data signify that individuals have
four opportunities in a day to meet the recommended daily food group
amounts in the Healthy U.S.-Style Dietary Pattern, and thereby satisfy
their nutritional needs. The food group amounts recommended by the
Dietary Guidelines, 2020-2025 (e.g., 2 c-eq/day of fruit) are total
recommended amounts for the day, not for individual foods, meals, or
snacks. The recommended daily amounts of food groups provided by the
Dietary Guidelines, 2020-2025 are not dependent on number of eating
occasions. In determining the food group requirements for ``healthy,''
the total daily amount of food groups are divided across the number of
eating occasions as determined by the data from national consumption
surveys. National consumption data over the last several decades,
(i.e., the USDA Continuing Survey of Food Intakes by Individuals 1989-
91 and Diet and Health Knowledge Survey 1989-91 (CSFII/DHKS 1989-1991)
through the 2015-2016 National Health and Nutrition Examination Survey
[[Page 106080]]
(NHANES)) (Refs. 2, 36, and 37) demonstrate that the highest percentage
of the U.S. population ages 4 and older reported four eating occasions
per day. Note that we excluded beverage-only eating occasions from our
analysis of the 2015-2016 NHANES data to focus only on eating occasions
that provided consumers with a meaningful opportunity to consume foods
from all the recommended food groups.
While some comments question the equal division among the four
eating occasions, we decline to change this method for the final rule.
For this rule, we analyzed the most current national consumption data,
the 2017-March 2020 NHANES (Refs. 2 and 38), and determined that the
median number of eating occasions (meals plus snacks) per day continues
to be four eating occasions (not including beverage-only eating
occasions) (Refs. 2 and 38). The data from NHANES 2017-2020 describe
both the number of meals eaten per day and the number of snacks eaten
per day. The data demonstrate that the highest percentage of people
reported eating three meals per day. The highest percentage of people
also reported eating one snack per day. Analysis of the combined eating
occasion data show that the highest percentage of people reported
having four eating occasions per day (meals plus snacks). We note that
a study cited in the comments examined the same NHANES data that we
used in our analysis. However, the study considered reports of
beverage-only occasions whereas we excluded beverage-only occasions.
Therefore, total number of eating occasions are different.
The typical sizes of meals and snacks may differ but are not
weighted differently when dividing the recommended daily food group
amounts to determine the FGE amounts. This is because the meals and the
snack are all eating occasions that provide consumers with an equal
opportunity to consume foods from the recommended food groups. For
example, the recommended daily amount for fruit is 2 cups per day, and
consumers have the opportunity to consume fruit at all three meals and
at a snack. Therefore, it is reasonable to divide the recommended daily
amount for fruit among the four eating occasions equally, which results
in an FGE amount of \1/2\ c-eq of fruit (2 c-eq divided by four eating
occasions). We further note that this method is consistent with FDA's
method in previous labeling rulemakings and relies on the same
rationale (see final rules on general requirements for health claims
and nutrient content claims in food labeling, 58 FR 2478 at 2495 and 58
FR 2302 at 2379-2380).
3. FGEs for Vegetables
(Comment 15) Some comments request that FDA provide more guidance
on how to convert various forms of fruit and vegetable groups into a
\1/2\ c-eq vegetables per RACC that we proposed as the FGE amount for
vegetables, taking into consideration the changes in density that occur
from processing steps such as chopping, pureeing, grating, and cooking.
The comments also ask that FDA provide guidance on how to convert dried
fruits and vegetables, including those in powdered forms, into the
whole equivalent ``single strength'' form for purposes of determining
the food group contribution.
(Response 15) We are aware that the examples of FGEs described in
the proposed rule did not represent all possible forms of foods,
including different forms of vegetable products, such as chopped,
dried, or grated vegetables. However, as noted in the proposed rule,
the FGEs are based on the cup- and ounce-equivalents developed for the
Dietary Guidelines, 2020-2025 (Ref. 1). The Dietary Guidelines, 2020-
2025 and the FPED (Ref. 3), which is used to develop the Healthy
Dietary Patterns for the guidelines, provide detailed information about
cup- and ounce-equivalents of different foods and beverages and are
resources that can help manufacturers determine the appropriate FGE
amounts. For example, the FPED describes that sliced, diced, or chopped
raw vegetables are given the same cup weight and the cup weights are
typically the average weights of different cuts. The FPED provides the
example of raw carrots which are assigned a 125-gram cup weight, which
is an average of one cup of sliced (122 g) and chopped (128 g) carrots
(Ref. 3). We note that, as explained in Response 44, vegetable powders
may be considered in the calculation of vegetable FGEs, which
represents a change from the proposed rule.
(Comment 16) Some comments support FDA's approach to include FGEs
in the proposed ``healthy'' criteria on the basis that it would
encourage increased consumption of fruits and vegetables but assert
that the proposed approach to FGEs may limit products that can meet the
requirements because they do not provide the required amount of FGEs.
The comments assert that FDA should allow products to count ``partial
FGEs,'' which could allow additional products to meet the FGE
requirement for vegetables.
(Response 16) As explained in Response 8, we do not intend to
exclude foods consumed in small amounts that are recommended for
healthful dietary patterns, including various vegetable products. Thus,
we revised the rule at Sec. 101.65(d)(3)(ii)(B) to provide methods for
addressing the qualification of foods with small RACCs. We also revised
the rule, at Sec. 101.65(d)(i), to include a single-ingredient
exemption, which expands the exemption for raw, whole fruits and
vegetables to other nutrient-dense forms of fruits and vegetables (as
well as to foods in other food groups). The expanded exemption will
result in more fruit and vegetable products (i.e., single-ingredient
fruits and vegetables without added ingredients besides water)
qualifying for ``healthy,'' regardless of their RACC size (e.g.,
chopped or frozen fruits and vegetables). This single-ingredient
exemption is discussed in Response 9.
(Comment 17) Some comments urge FDA to consolidate the food groups
for fruits and vegetables. The comments assert that combining the fruit
and vegetable food groups would avoid ``arbitrary distinctions'' for
products that contain a mixture of fruits and vegetables, and that a
product that contains meaningful amounts of fruits, vegetables, or
fruits and vegetables together should be treated the same, regardless
of the precise contribution to the fruit group versus the vegetable
group. One comment requests that FDA combine the fruit and vegetable
groups for children ages 1-3 to provide flexibility for foods that
contain meaningful amounts of fruits and vegetables collectively.
(Response 17) We decline to combine the fruit and vegetable food
groups in this final rule. Fruits and vegetables are considered
different food groups in the Dietary Guidelines and have separate daily
recommended intake amounts. As noted on the MyPlate website (<a href="https://www.myplate.gov/">https://www.myplate.gov/</a>), while botanically, most vegetables are considered
fruits, the two groups are separated for nutritional and culinary
purposes, meaning distinctions are made based on nutrient content, use
in meals, and taste (e.g., fruits are generally considered sweet or
tart, while vegetables are not). Each food group provides a particular
array of nutrients, and the recommended intake amounts of the different
food groups reflect dietary patterns that are associated with positive
health outcomes (Ref. 1). Healthy dietary patterns include intakes of
foods from across the different food groups recommended by the Dietary
Guidelines, including the fruit and vegetable food groups. Thus,
vegetables
[[Page 106081]]
and fruits are distinct food groups that contribute their own nutrients
and have separate recommended amounts for healthy dietary patterns.
This distinction is applicable to foods directed at all ages, including
foods intended for consumption by children over 2 years of age. As
discussed in the Dietary Guidelines, individuals in all life stages are
encouraged to consume foods from across all food groups to meet
nutrient intake needs. Finally, the comments suggesting combining the
vegetable and fruit group FGEs did not provide information on the
benefits of combining the two food groups nor the effects such an
action would have on the ability to construct healthy dietary patterns,
and thus we have no basis on which to make such a change.
Considering the conventional distinction between fruits and
vegetables in diets and food preparation purposes, the differences in
nutrient contributions from the two food groups, and consistency with
the Dietary Guidelines, we do not agree that the vegetable and fruit
food groups should be combined. The rule, therefore, retains the
framework of the vegetable food group and fruit food group as two
distinct food groups. However, we have modified the criteria in other
ways to provide additional flexibility for mixed products, for example,
with the expanded single-ingredient exemption for nutrient-dense foods
encouraged by the Dietary Guidelines (see Response 9, Sec.
101.65(d)(3)(i)), and for mixed products, main dishes, and meals, for
example, through added flexibility in the proportions required for FGE
requirements (see Response 106, Sec. 101.65(d)(3)(iii)-(v)). These
modifications should help address the comments' concerns relating to
the requirements for mixed products containing a mix of fruits and
vegetables. For example, mixed products, such as a frozen mix of fruit
and vegetables or a blend of 100% juices that contains 80% fruit juice
and 20% vegetable juice, that do not contain additional ingredients
besides water, will automatically qualify to bear the claim under the
expanded single-ingredient exemption.
4. FGEs for Fruits
(Comment 18) Some comments request that FDA provide more guidance
on how to convert various forms of fruit and vegetable groups into a
\1/2\ cup, taking into consideration the changes in density that occur
from processing steps such as chopping, pureeing, grating, and cooking.
One comment notes that moisture and solid levels vary among fruits and
vegetables, and the conversion of 1 cup fresh or cooked fruits or
vegetables to \1/2\ cup dried fruits and vegetables may not accurately
reflect all types of fruits and vegetables. The comment requests that
FDA allow food companies flexibility to use reasonable options for
determining FGEs of their products when converting between dried and
rehydrated forms of fruits and vegetables.
(Response 18) We recognize that additional information on FGEs may
be helpful and we respond to the comments requesting options for
determining FGEs for different forms of fruit products, such as dried
and rehydrated fruits (with regard to both vegetables and fruits) above
in section V.C.3 (``FGEs for Vegetables''). We also provide information
about available resources to support the determination of FGE amounts
in Response 6 and 12.
(Comment 19) A number of comments do not support a ``healthy''
claim being on 100% fruit juice. One comment provides that, although
100% fruit juice in small amounts may offer a way for people to obtain
important nutrients and contribute to dietary recommendations for fruit
intake, 100% fruit juice is likely to be overconsumed because of its
high palatability and accessibility. The comment says that the presence
of a ``healthy'' claim may promote excess consumption of 100% fruit
juice, which could contribute large amounts of unnecessary calories and
sugar to the diet. Some comments note that the Dietary Guidelines,
2020-2025 provides that whole fruit is the preferred way to meet the
recommended fruit intake amounts.
(Response 19) We disagree that 100% juice should not be able to
qualify to bear the ``healthy'' claim. The Dietary Guidelines, 2020-
2025 states that foods in the fruit food group include both whole
fruits and 100% juice, and the Healthy U.S.-Style Dietary Pattern for
ages 2 and older includes 100% juice as a food that contributes to the
healthy dietary pattern. As discussed in the 2020 DGAC report, 100%
juice is a nutrient-dense food that does not contribute energy through
added sugars and contributes to meeting nutrient and food group needs
(Ref. 8). The comments suggesting that 100% fruit juices being labeled
as ``healthy'' may promote excess consumption do not provide evidence
that would contradict or cause us to question the Dietary Guidelines,
2020-2025. As discussed elsewhere, the purpose of this rule is to help
consumers identify foods that are particularly useful in creating a
diet that is consistent with dietary recommendations. Based on the
contributions of 100% juice, including both fruit and vegetable juice,
to healthy dietary patterns as presented in the Dietary Guidelines,
2020-2025 and Healthy U.S.-Style Dietary Pattern for ages 2 and older,
we are including 100% fruit and vegetable juice among foods that are
eligible to bear the ``healthy'' claim (Ref. 1). Additionally, we
include in this rule a single-ingredient exemption for nutrient-dense
foods that are encouraged by the Dietary Guidelines with no added
ingredients, except for water (see Response 9).
(Comment 20) Some comments do not support fruit puree and fruit
paste being able to qualify for the ``healthy'' claim because,
according to the comments, they often do not contain fiber-containing
parts of the whole fruit and are seldom consumed independently. For
example, if the whole fruit or vegetable is not used in making the
purees or pastes, such as if the skin is removed from apples before
making applesauce, then the purees could have lower fiber content than
the whole fruit or vegetable.
(Response 20) As stated in the proposed rule (87 FR 59168 at
59184), FDA considers concentrated fruit and vegetable purees and
pastes to be fruits and vegetables for the purpose of calculating FGEs
because these products are essentially fruits and vegetables that have
been processed to change the physical form of the fruit or vegetable
and to remove moisture. While removal of the skin of fruits and
vegetables for concentrated fruit and vegetable purees and pastes may
affect total fiber content compared with whole, intact fruits and
vegetables, the Dietary Guidelines, 2020-2025 includes purees, such as
applesauce, in the food groups for fruits without qualification related
specifically to fiber content. Fruits and vegetables provide a wide
array of nutrients and are consumed in a wide variety of forms. Some
forms of fruits and vegetables are consumed without skins, even when
the skins are edible, such as in canned and frozen varieties. Even with
the removal of fruits and vegetable skins, the overall nutrient
profiles of purees and pastes remain within the range of the varied
available forms of fruits and vegetables. For the development of the
Healthy U.S.-Style Dietary Pattern, the FPED also included applesauce
puree with a c-eq of 245 g. Similarly, pastes, such as tomato paste,
are included in the food group for vegetables and the FPED provides a
c-eq of 120 g. Fruit and vegetable purees and pastes are foods that are
included in the fruit and vegetable food groups in the Dietary
Guidelines. Thus, under the final rule, fruit and vegetable purees and
paste are eligible to bear a ``healthy''
[[Page 106082]]
claim as individual vegetable foods, if they meet the applicable FGE
and NTL criteria (see Sec. 101.65(d)(3)(ii)). Furthermore, fruit and
vegetable pastes and purees that contain no other ingredients, except
for the addition of water, would be included under the single-
ingredient exemption (see Response 9, Sec. 101.65(d)(3)(i)). In
addition, although fruit pastes and purees can be used as ingredients
in foods such as yogurts and bakery products, the mere presence of
pastes and purees in those products does not enable such products to
qualify for use of the claim. Food products, such as bakery products
containing fruit pastes and purees, would continue to be evaluated
based on the overall criteria set forth for their food category.
Likewise, packaged products of fruit pastes and purees would be
evaluated on the criteria set forth for fruit products, regardless of
any potential use as ingredients in other food products.
5. FGE for Grains and Whole Grains
(Comment 21) Many comments support the general approach to grain
products (i.e., that grain products must contain a \3/4\ oz-eq of whole
grains to bear the ``healthy'' claim) and mention that the approach
supports consumers in achieving the Dietary Guidelines recommendation
that at least half of total grains consumed be whole grains. However,
some comments assert that grain products should have to meet additional
criteria to qualify for the ``healthy'' claim, such as being required
to be nearly 100% whole grain and minimally processed.
(Response 21) We developed the FGEs to help consumers identify
foods that can help them meet the recommended daily food group amounts
as described in the Dietary Guidelines, 2020-2025 and the Healthy U.S.-
Style Dietary Pattern. Whole grains are grains that have the entire
grain kernel, which includes the bran, germ, and endosperm, while
refined grains have been processed to remove the bran and germ. Some
refined grains are enriched. Enriched grain products are refined grains
that have specific nutrients added back to replace losses of the
nutrients that occur during processing (Ref. 4). Setting the FGE for
grain products at \3/4\ oz-eq of whole grains helps consumers identify
foods that can help them meet the recommended 3 oz-eq of whole grains
per day. Although some comments suggest that grain products labeled
``healthy'' should be entirely whole grains and/or minimally processed,
we find that those conditions are unnecessary if the food contains an
FGE of whole grains. A food that contains a full FGE of whole grains,
but is not 100% whole grain or is processed, still contributes to
meeting the recommended daily amount of 3 oz-eq of whole grains per
day, which supports the primary objective of the FGEs. Therefore, we
decline to require proportions of overall whole grains or processing
limitations to whole grain foods beyond the criteria set in the
definition. We note that the Dietary Guidelines 2020-2025 recommends
that any refined grains that consumers choose be enriched grains.
(Comment 22) Some comments request that we adjust the proposed FGE
requirement for whole grains to align with the recommendations in the
Dietary Guidelines, 2020-2025, which is 8 g of whole grains per 1 oz-eq
(i.e., if half of the grains are whole grains). One comment provides
that the Dietary Guidelines recommends 6 ounce-equivalents of grain
foods per day, with at least half of those being whole grains.
According to the comment, under the proposed rule, foods with 8 g whole
grain per oz-eq that meet the nutrient limits for saturated fat, added
sugars, and sodium would not qualify for the ``healthy'' claim. The
comment suggests that FDA align the whole grain threshold with the
recommendations in the Dietary Guidelines, 2020-2025 of 8 g per oz-eq.
The comment also recommends that the requirements for the whole grain
criteria be provided in grams present per reference amount.
(Response 22) Although the Dietary Guidelines, 2020-2025 provides
individuals with multiple strategies to facilitate shifts in eating
habits, the primary objective of the food group recommendations is to
help consumers meet the recommended 3 oz-eq of whole grains per day.
Both the Dietary Guidelines, 2020-2025 and the FPED explain that a 1
oz-eq of whole grains is 16 g of whole grains. The comments suggest
that the criteria should align with one of the strategies to facilitate
shifts in eating habits discussed in the Dietary Guidelines, 2020-2025
to choose foods whose grain components are comprised of at least 50%
whole grains, which would be 8 g per oz-eq. However, the FGE
requirement for whole grains included in the updated ``healthy''
criteria is based on the Dietary Guidelines' recommended amount of 3
oz-eq of whole grains per day. To determine the amount of FGE required
for a food to bear the ``healthy'' claim, the recommended daily food
group amounts are divided among the four eating occasions typically
consumed. Consequently, the rule sets the FGE for grains at \3/4\ oz-eq
of whole grains (see Sec. 101.65(d)(2)), which would be calculated as
12 g of whole grains per RACC (16 g of whole grains multiplied by \3/
4\). Therefore, we are not lowering the amount of whole grains needed
to qualify, as the goal of this FGE is to help consumers identify foods
that can help them reach the 3 oz-eq per day recommended for whole
grains. The strategies discussed in the Dietary Guidelines, 2020-2025
to help people consume more whole grains can be helpful, however, and
can be communicated to consumers in many ways, both on food labels and
through communications and education outside of labeling.
Additionally, we decline to shift to using gram amounts as the
basis for compliance with the FGE requirements, as suggested by the
comment. As discussed in Response 33, the concepts of cup and ounce
equivalents incorporate the calculation of the specific gram weights of
individual foods. The use of oz-eq for the whole grain FGE allows for
the calculation of gram amounts for individual foods. FGEs in cup- and
ounce-equivalents allow for the calculation of specific amounts of FGEs
in foods, including in grams, that exist in a wide variety of forms and
that could be measured in different measurement units.
(Comment 23) Some comments on the whole grain FGEs request that we
provide additional guidance and examples on how to calculate the FGEs.
The comments also indicate that the FGE calculations could potentially
exclude a wide variety of foods which are inherently whole grain, such
as whole wheat flour, and foods made from whole grains, such as whole
wheat bagels.
(Response 23) We discuss some examples of resources for the
determination of FGE amounts in Response 12. As noted in Response 12,
the final rule sets a compliance date that is 3 years from the
effective date, and we intend to provide additional resources to help
manufacturers comply with the final rule before the end of the
compliance period. Additionally, because of the single-ingredient
exemption that we are providing (Sec. 101.65(d)(3)(i)), single-
ingredient whole grains that meet the criteria for the single-
ingredient exemption would automatically qualify for the claim without
having to meet FGE or NTL criteria.
(Comment 24) Several comments assert that refined grain foods with
an inherent or fortified nutrient to encourage should be able to bear a
``healthy'' claim as they can be part of a healthy dietary pattern and
are encouraged by the Dietary Guidelines,
[[Page 106083]]
2020-2025. The comments mention that the Dietary Guidelines, 2020-2025
does not require that all grains are whole, but instead encourages
people to ``make half their grains whole'' and to choose enriched grain
products when consuming refined grains. The comments provide that
enrichment and fortification of grains improves intake of several
nutrients, including nutrients such as iron and folate, which are
critical for women of childbearing age.
Some comments note that although FDA's food group approach to
``healthy'' labeling is conceptually reasonable and may work well for
some food groups, the approach raises concerns when applied to the
grain group. The comments urge FDA to ensure that the ``healthy''
criteria do not unintentionally discourage consumption of other grain
foods recommended by the Dietary Guidelines, including enriched grains,
asserting that less than 8% of Americans consume the minimum
recommendation for whole grain foods and that fiber is an underconsumed
food component. The comments ask that the ``healthy'' labeling
distinguish staple grain foods from ``indulgent grain products'' that
should be consumed less often.
Another comment asserts that the ``healthy'' nutrient content claim
should allow refined or enriched grains to use the healthy claim if
they provide a good or excellent source of fiber and meet the added
sugar, saturated fat, and sodium limits. According to the comment, the
main concern cited in the Dietary Guidelines, 2020-2025 regarding
refined grains is that they commonly contain added sugar, sodium, and
saturated fat. The comment states that if a product meets the criteria
for added sugars, sodium, and saturated fat and contains one or more
components of public health concern (i.e., those that are underconsumed
in the U.S. population) at meaningful levels, that product should be
included in a healthy eating pattern.
(Response 24) As previously stated, the purpose of the ``healthy''
claim is to highlight those foods that are particularly useful in
creating a diet that is consistent with current dietary guidelines. For
grains consumption, the Dietary Guidelines, 2020-2025 states that
healthy dietary patterns include whole grains and limit the intake of
refined grains. While refined grains can be included in a healthy diet,
the objective identified in the Dietary Guidelines, 2020-2025 is to
meet the recommended daily amount of grain foods intake mostly through
whole grains. Most Americans already meet the recommendations for
overall grain intake in their diets. However, 98% do not meet the whole
grain intake recommendations, and 74% consume more refined grains than
recommended (Ref. 1). The ``healthy'' claim can help consumers identify
the whole grain foods that are characteristic of a healthy dietary
pattern so that they may shift grain consumption from predominantly
refined grains to more whole grains. Although we recognize that some
refined grain foods are staple foods for some groups and may contain
important nutrients such as iron or fiber, they are not among the core
elements included in healthy dietary patterns. For this reason, the
FGEs for grain foods in the rule are set to a specific amount of whole
grains, not refined grains (Sec. 101.65(d)(2)). Additionally, a food
that contains a full FGE of whole grains, but is not 100% whole grain
(i.e., also contains refined grains), could still meet the FGE criteria
to qualify for the ``healthy'' claim. Even though the food is not 100%
whole grain, it would still contribute to meeting the recommended daily
amount of 3 oz-eq of whole grains, which supports the primary objective
of the FGEs. While certain foods containing refined or enriched grains
may not contain any whole grains, they could contain full FGEs from
other food groups, such as vegetables. Based on the entire composition
of the food product and the presence of other food group components,
these products may also be able to qualify for the ``healthy'' claim.
(Comment 25) A number of comments mention that the proposed rule
would disqualify many grain foods, including the majority of ready-to-
eat cereals on the market, from using the term ``healthy.'' The
comments note that research shows ready-to-eat cereal is one of the
most affordable, accessible, and nutrient-dense breakfast choices a
person can make.
(Response 25) As discussed in the previous response, whole grains
are core elements of a healthy dietary pattern; accordingly, the rule
sets the grain FGE with whole grain requirements and does not include
requirements for refined grains. Ready-to-eat cereals that are
comprised primarily of refined grains instead of whole grains may not
be able to meet the FGE for whole grains in the rule and qualify for
use of the ``healthy'' claim. However, there are many cereals on the
market that are made with whole grains, and our review of the current
food marketplace showed that many of these cereals contain the rule's
required FGE amount of whole grains (Ref. 2). Furthermore, while there
are cereals made with whole grains that do not currently meet the FGE
for whole grains in the rule, some have levels of whole grain that are
close to the \3/4\ oz-eq FGE amount, and manufacturers could choose to
reformulate the product to meet the rule's FGE requirement, should they
want the product to qualify for the ``healthy'' claim.
Ready-to-eat cereals currently made with refined grains, and those
with whole grains in amounts that do not meet the required FGE amount,
can still play a role in the diets of consumers. Foods that do not
qualify for use of the claim are not necessarily ``unhealthy'' or
unable to provide any nutritional benefits to consumers. As previously
discussed, the purpose of the ``healthy'' claim is to highlight those
foods that are particularly useful in creating a diet that is
consistent with current dietary guidelines. Ready-to-eat cereals,
especially those without or with low levels of added sugars, sodium,
and saturated fat, can provide numerous nutrients, such as iron or
folate, and manufacturers can continue to communicate those nutritional
attributes in many different ways.
(Comment 26) One comment requests lowering the proposed \3/4\ oz-eq
of whole grain per RACC requirement for products with a RACC of 15 g or
less to 0.375 oz-eq per RACC. The comment expresses that many of its
products that mainly contain whole grains would be unable to qualify as
``healthy'' under the proposed rule because, given their small RACC,
they would not be able to meet the \3/4\ ounce-equivalent of whole
grain.
(Response 26) As discussed earlier, we acknowledge that certain
foods recommended by current nutrition science and Federal dietary
guidance would be unable to meet the proposed criteria for the healthy
claim due to being typically consumed in small amounts. Therefore, the
rule now applies the ``healthy'' criteria to individual foods with a
RACC of 50 g or less or 3 Tbsp or less on a per 50 g basis instead of a
per RACC basis (see Sec. 101.65(d)(3)(ii)). Applying the ``healthy''
criteria to grain products that have RACCs of 15 g on a 50 g basis,
results in foods of this RACC size to meet the FGE of \3/4\ oz-eq of
whole grains. For example, a grain food with a RACC of 15 g that
contained 0.375 oz-eq of whole grains, which would be equal to 6 g of
whole grains, can qualify on a per 50 g basis. The calculated amount of
whole grains in that food would be 20 g of whole grains per 50 g (50 g
divided by 15 g and then multiplied by 6 g and then rounded up to 20
g). This food qualifies for the FGE of \3/4\ oz-eq (12 g). Therefore,
lowering the FGE amount, as suggested in the comment, is unnecessary,
and the
[[Page 106084]]
concern raised by the comment is addressed by the fact that foods of
that RACC size can now meet the whole grain FGE on a per 50 g basis. As
such, we decline to lower the FGE amount. The final rule retains the
FGE requirement for grains of \3/4\ oz eq whole grains (Sec.
101.65(d)(3)(ii)(B)).
(Comment 27) Some comments express that FDA's sole focus on whole
grains as the criteria for grain products to qualify for the
``healthy'' claim is overly simplistic and would not address the
Dietary Guidelines recommendations of a balanced diet. The comments
request that FDA provide updated educational resources for consumers on
choosing all types of grains, including enriched refined grains without
solid fats or sugars, to meet Dietary Guidelines recommendations.
(Response 27) The objective of the Dietary Guidelines, 2020-2025 is
to encourage consumption of those foods and food groups that are common
in healthy dietary patterns, and the ``healthy'' claim can help
consumers identify foods that are particularly useful in helping them
achieve a diet consistent with current dietary recommendations. We
explained earlier why the criteria for the ``healthy'' claim will focus
on whole grains and not refined grains, as whole grains are core
elements of healthy dietary patterns. For the same reasons, we intend
to focus our educational efforts on consumption of whole grains. We
have, however, expressed throughout this rule that foods that are
unable to qualify for the ``healthy'' claim are not ``unhealthy'' and
can still be incorporated as part of a healthy dietary pattern. We plan
to also incorporate this messaging in consumer education efforts
related to the ``healthy'' claim.
(Comment 28) One comment asserts that the labeling of grain foods
is confusing in part due to misleading advertising and encourages FDA
to improve the labeling of whole grains to improve transparency for
consumers. The comment asks that whole grain products that meet the
criteria for the ``healthy'' labeling claim be required to disclose the
percentage of both whole and refined grains.
(Response 28) We have determined that setting the FGE for grain
products at \3/4\ oz-eq of whole grains helps consumers identify foods
that can help them meet the Dietary Guidelines, 2020-2025 recommended 3
oz-eq of whole grains per day. A food that contains a full FGE of whole
grains, but is not 100% whole grain, still contributes to meeting the
recommended daily amount of 3 oz-eq, which supports the primary
objective of the FGEs. For these reasons, we decline to require
additional information about grain content or any other qualifying
criteria as part of the ``healthy'' claim. However, if manufacturers
choose to do so, they may use other claims and truthful and non-
misleading statements about the nutritional qualities of their foods in
addition to the use of the ``healthy'' claim. For example, a food that
bears a ``healthy'' claim could also make claims about whole grain or
fiber content, provided that the food meets all applicable requirements
for such claims.
6. FGE for Dairy
(Comment 29) Some comments disagree with the proposed \3/4\ c-eq
per RACC for the dairy group to qualify for the ``healthy'' claim,
stating that it is confusing to consumers and places an unnecessary
burden on industry. The comments assert that the \3/4\ c-eq for dairy
is less actionable for consumers because it does not equate to a
recommended serving as provided in the Dietary Guidelines.
Some comments urge FDA to adopt an FGE of \1/2\ c-eq dairy for
natural cheese. The comments note that few cheeses would qualify for
the ``healthy'' nutrient content claim under the proposed ``healthy''
definition. A number of comments assert that using the proposed \3/4\
c-eq for dairy would cause many cheeses, including fat-free or low-fat
forms, to be unable to bear the ``healthy'' claim, based solely on the
amount of serving equivalents set by the Dietary Guidelines, 2020-2025
and the defined RACCs. The comments also state that it may be difficult
to determine whether a cheese is eligible for a healthy claim, because
cheeses have varying weights and densities.
(Response 29) In response to these comments, we reviewed the
current marketplace related to the RACC sizes of different dairy
products and the amounts of FGEs contained in those foods (Ref. 2).
This review showed that the comments were correct that a number of
dairy foods, including some cheeses and many yogurts, would not meet
the proposed FGE of \3/4\ c-eq of dairy. However, the amount of dairy
in many of those products was close to meeting the FGE amounts (ranging
from about 0.69 to 0.71 c-eq per RACC). Dairy products, including milk,
yogurt, and cheese, especially in fat-free and low-fat forms, are
included in the Dietary Guidelines, 2020-2025 as core elements of
healthy dietary patterns. Although the proposed FGE threshold was set
to help consumers identify foods that could help them meet the
recommended daily amount of dairy, we do not intend to exclude
nutrient-dense foods that are recommended for healthful dietary
patterns. We have already addressed the issue of foods with small RACCs
in Response 8 and the methods provided for addressing small RACC foods
will result in many dairy foods with small RACCs, such as natural
cheeses, being able to meet the FGE amounts. However, there are some
other dairy foods that do not have small RACCs and that still would not
meet the FGE amounts. Therefore, we have revised the FGE threshold for
dairy in the rule to \2/3\ c-eq per RACC (see Sec. 101.65(d)(2)).
Examples of \2/3\ c-eq of dairy are \2/3\ cup fat-free or low-fat milk,
yogurt, or lactose-free versions of these products, or fortified soy
beverage or yogurt alternatives; and 1 oz natural cheese or \2/3\ oz
processed cheese.
As discussed, the FGE threshold was set to help consumers identify
foods that could help them meet the recommended daily amount of dairy,
which is 3 c-eq per day. With an FGE set at \2/3\ c-eq and an
opportunity for consumption at four eating occasions per day, the daily
amount achieved would be 2 \2/3\ c-eq of dairy per day (\2/3\ c-eq
multiplied by four), and the total amount consumed would be close to
the recommended 3 c-eq daily intake. Setting the FGE at a lower level
will result in more dairy foods being able to meet requirements for the
``healthy'' claim, which could provide more dairy options labeled as
``healthy'' for consumers to choose from. Dairy products are
underconsumed in the United States, with 90% of consumers not meeting
the daily recommendation currently (Ref. 1). The adjustment to the
dairy FGE is similar to how adjustments were made to some FGEs in the
proposed rule, such as the vegetable food group, which is also
underconsumed. Because vegetables are underconsumed with 90% of
consumers not meeting the vegetable intake recommendation, the FGE
amount was slightly rounded down to \1/2\ c-eq. Setting the FGE
requirements for underconsumed food groups at a slightly lower amount
makes it easier for foods in those groups to qualify for the claim and
allows for more foods on the market to be labeled ``healthy.'' More
nutrient-dense dairy options being able to be labeled as ``healthy''
may help consumers in identifying and choosing nutrient-dense dairy
options that can help them meet the daily recommendation.
Although some comments suggest setting the FGE threshold at even
lower amounts than \2/3\ c-eq, such as \1/2\ c-eq, amounts lower than
\2/3\ c-eq would make meeting the daily recommended amount
[[Page 106085]]
for dairy difficult. Requiring a minimum of \2/3\ c-eq for the dairy
FGE to meet the FGE requirement for the ``healthy'' claim would enable
consumers to identify dairy products that would help them approach
meeting the daily recommended amounts for dairy and result in many
nutrient-dense dairy options qualifying for the ``healthy'' claim. We
note that the FGE amounts are criteria for manufacturers to use when
determining if a product qualifies for the ``healthy'' claim. The
presence of a ``healthy'' claim on a product that meets the criteria
will simply help consumers to identify foundational foods for building
healthy dietary patterns. To support this goal, we intend to engage in
consumer education efforts related to the ``healthy'' claim.
(Comment 30) One comment notes that there are disparities in dairy
consumption related to race and ethnicity, with non-Hispanic Black and
Asian children and adults consuming the least amount of dairy. The
comment also mentions that lactose intolerance is significantly more
prevalent among Black and Hispanic Americans than in non-Hispanic white
populations, and that natural cheeses such as cheddar, mozzarella, and
Monterey Jack are ``virtually lactose-free'' dairy options upon which
individuals with lactose intolerance rely. According to the comment,
limiting the labeling of cheese as a ``healthy'' food could further
widen the disparity gap in dairy consumption. The comment asserts that
dairy consumption needs to be encouraged across age, race, and ethnic
groups to achieve the daily dairy recommendation as a part of healthy
eating patterns to help advance health equity. Some comments note that
plant-based dairy foods are alternative dairy sources for those with
lactose intolerance.
(Response 30) The criteria for foods to bear the ``healthy'' claim
are intended to help consumers identify foods that are foundational to
a healthy dietary pattern. As noted in Response 29, we have lowered the
FGE amount for dairy to \2/3\ c-eq, which will result in more dairy
foods being able to meet the FGE requirements for the ``healthy'' claim
and may result in more dairy options labeled as ``healthy'' for
consumers to choose from (e.g., more yogurts). There are other options
in the dairy group for individuals who are lactose intolerant that
could qualify for ``healthy,'' such as certain lactose-free versions of
dairy products or certain dairy products that are naturally lactose-
free. Also, fortified soy milk, and plant-based dairy alternatives with
similar nutrient composition as dairy are included in the dairy food
group for the purposes of the ``healthy'' claim, which can provide
alternatives to individuals who are lactose-intolerant. The Dietary
Guidelines, 2015-2020 discusses that key nutrient contributions from
dairy foods include calcium, protein, vitamin A, vitamin D, magnesium,
phosphorous, potassium, riboflavin, vitamin B12, zinc, choline, and
selenium (Ref. 4). As we noted earlier in this rule, while not all
dairy foods may qualify for use of the claim, the use of the
``healthy'' claim on some foods is not intended to signal that all
other foods are ``unhealthy,'' including foods consumed by certain
subgroups of the population (see section III.A (``Need for the
Regulation/History of This Rulemaking''). Other foods are still
available for consumption and manufacturers can communicate truthful
and non-misleading information about lactose-free foods or information
that encourages culturally appropriate consumption of dairy foods on
the food label outside of use of the ``healthy'' claim.
(Comment 31) Some comments assert that ambiguity in the
determination of the FGEs of certain dairy foods, including yogurt,
could lead to inconsistency in manufacturer calculations of FGEs and
confusion among consumers. A number of comments request that FDA
provide a list, examples, or maintain a database for manufacturers to
use in calculating the amount of FGEs delivered by each food.
(Response 31) The comments on the dairy FGEs echoed the requests in
the comments across the food groups for guidance in determining the FGE
amounts for foods in this group. We provide a general discussion on
available resources to support determination of FGE amounts in Response
12. For example, fluid milks and yogurts are calculated at 245 g for a
one c-eq in the FPED database (Ref. 3). As noted in Response 12, the
final rule sets a compliance date that is 3 years from the effective
date, and we intend to provide additional resources to help
manufacturers comply with the final rule before the end of the
compliance period.
(Comment 32) Some comments request guidance regarding what dairy
alternatives might be considered ``healthy.'' Some comments note that,
according to the Dietary Guidelines, alternative beverages such as
almond, rice, coconut, or hemp milks are not nutritionally equivalent
to milk and are therefore not included in the dairy foods group. The
comments note that dairy foods contribute nutrients such as calcium,
vitamin D, and potassium to the American diet. One comment provides
that, according to the Dietary Guidelines, only fortified soy products
are nutritionally similar to dairy products and can serve as a
replacement to dairy products. However, other comments support the
inclusion of plant-based dairy alternatives in the dairy group. The
comments mention that many people do not consume dairy products for a
variety of reasons, such as allergy, intolerance, cultural practices,
or preference. Many comments that support inclusion of plant-based
dairy alternatives in the dairy group request that FDA set forth
specific nutritional criteria that plant-based dairy alternatives must
meet to qualify for the ``healthy'' claim. One comment asserts that if
FDA permits nutritional comparisons between plant-based and traditional
dairy products through the use of the term ``healthy,'' then FDA should
require the plant-based products to bear the imitation labeling
outlined in Sec. 101.3(e) (21 CFR 101.3(e)).
(Response 32) In the proposed rule (87 FR 59168 at 59187), we
determined that including fortified plant-based dairy alternatives
among the food options in the dairy group can help consumers identify
foods that can help them increase their dairy group intake and meet the
dairy group daily intake recommendations. We specifically limited
plant-based milk alternatives and plant-based yogurt alternatives that
could qualify for the claim to those products whose overall nutritional
content is similar to dairy foods (e.g., provide similar amounts of
protein, calcium, potassium, vitamin D, and other nutrients) and are
used as alternatives to milk and yogurt. We discussed in the proposed
rule that, when the Dietary Guidelines, 2020-2025 published, fortified
soy beverages and yogurts were the only alternatives that were
nutritionally comparable to dairy, and the composition data evaluated
by the Dietary Guidelines, 2020-2025 demonstrated that the nutrient
content in fortified soy beverages and yogurts is similar to that of
dairy. Plant-based dairy alternatives are formulated foods, with
evolving compositions and formulations. It is possible that plant-based
dairy alternatives from sources other than soy, such as almond milk or
oat milk, may be produced with nutritional profiles similar to dairy.
If plant-based dairy alternatives are formulated with nutritional
profiles similar to that of dairy, then it would be appropriate for
those products to be considered among the food options in the dairy
group. Although not mentioned in the proposed rule, in
[[Page 106086]]
addition to plant-based milk and yogurt alternatives, plant-based
cheese alternatives are also available on the market. Currently, these
plant-based cheese alternatives do not have similar nutrient
composition to cheese. However, as with plant-based milk and yogurt
alternatives, it is possible that in the future plant-based cheese
alternatives may be produced with nutritional profiles similar to that
of dairy. If those food products were to become available, they would
be considered under the criteria for the dairy group to qualify for use
of the ``healthy'' claim. We reiterate that, for purposes of this rule,
it is only those plant-based dairy alternatives that have similar
nutrition composition to dairy that will be included in the dairy group
for purposes of qualifying for the ``healthy'' claim. For example, soy-
based yogurt alternatives would need to have similar nutrient
composition to traditional milk-based yogurt. Plant-based milk
alternatives would, likewise, need to have similar nutrient composition
to milk to be considered under the criteria for dairy foods in this
rule. While nutrient profiles can vary among different dairy foods, the
Dietary Guidelines, 2015-2020 discusses that key nutrient contributions
from dairy foods include calcium, protein, vitamin A, vitamin D,
magnesium, phosphorous, potassium, riboflavin, vitamin B12, zinc,
choline, and selenium (Ref. 4). We note that FDA has also published a
draft guidance on the labeling of plant-based milk alternatives, and we
requested comment on nutrient profiles of plant-based milk alternatives
(Ref. 5). Requiring plant-based products to bear imitation labeling as
outlined in Sec. 101.3(e) is outside the scope of this rule.
(Comment 33) Some comments question the use of FGEs, cup- and
ounce-equivalents for the criteria for dairy foods. One comment notes
that FDA has departed from the use of a defined gram-basis, the RACC,
or labeled serving size as the basis for the ``healthy'' claim, without
explanation. The comment urges FDA to consider a basis that is specific
to certain types of dairy foods or the RACC.
(Response 33) The claim ``healthy' is a nutrient content claim and
the criteria are applied on a per RACC basis, as is typically the case
with nutrient content claims. The NTL criteria in the ``healthy''
definition are based on grams or milligrams per RACC, similar to other
claims, but are reflected as percentages of the DV to allow flexibility
in the future if there are changes in the DV for these nutrients. The
FGE criteria introduced in the ``healthy'' definition are applied on a
cup- and ounce-equivalent per RACC basis to be consistent with how food
group recommendations are provided for in relation to dietary patterns.
The Dietary Guidelines, 2020-2025 provides food group recommendations
in cup- and ounce-equivalents, such as 3 c-eq of dairy per day for a
reference 2,000-calorie diet. The daily recommended amounts of the food
groups are spread out throughout the day across an individual's eating
occasions. Therefore, the amounts per eating occasion are also in cup-
and ounce-equivalents. The concept of equivalents, however,
incorporates the calculation of the specific gram weights of individual
foods. In the example used earlier in this section for fluid milk and
yogurt, 245 g is a one c-eq, as calculated in the FPED database.
Calculating the FGE of \2/3\ c-eq results in an FGE amount of
approximately 163 g for milk and yogurt. The use of cup- and ounce-
equivalents allows for the calculation of specific amounts of foods
that exist in a wide variety of forms.
(Comment 34) One comment asserts that FDA is providing plant-based
dairy alternative products a competitive advantage because
manufacturers of these products may choose between two different FGEs
(protein foods or dairy).
(Response 34) As discussed in Response 35, there are some foods,
namely beans, peas, and lentils, that may be considered under either
the protein or the vegetable food group for calculation of FGEs.
However, plant-based dairy products that are labeled and marketed as
dairy alternatives will be evaluated against the criteria for the dairy
food group for the purposes of the ``healthy'' claim, as discussed in
Response 32. Therefore, manufacturers of plant-based dairy alternative
products are not able to choose between two different food groups for
the calculation of FGEs.
7. FGEs for Protein Foods
(Comment 35) One comment says that dry beans, dry peas, lentils,
and chickpeas, known as pulses, are rich sources of protein, potassium,
and dietary fiber, and provide other important minerals, such as
magnesium, choline, and iron, and minimal amounts of added sugar,
saturated fat, and sodium to the diet. The comment supports FDA's
proposal to permit beans, peas, and lentils to be categorized as either
a vegetable or a protein under the rule because the nutrient content is
similar to other foods in both the protein and vegetable groups. The
comment asserts that pulses are emerging in a variety of new forms,
including flours, powders, spreads, purees, pastas, and proteins, and
can be used in a wide variety of applications, such as pastas, plant-
based entrees, baked goods, and beverages. The comment asserts that
these varying forms contain the same nutritional benefits of pulses in
their whole form and maintains that FDA should provide flexibility to
allow for innovative pulse products to qualify as ``healthy.''
Other comments request that other sources of protein, including
protein powders, isolates, and concentrates from whey, soy, and pea, be
included in the protein foods group. The comments note that the Dietary
Guidelines, 2020-2025, includes soy flour, soy protein isolate, and soy
concentrate in the protein group and provides that soy includes tofu,
tempeh, and products made from soy flour, soy protein isolate, and soy
concentrate. The comments assert that all plant-based proteins should
be considered part of the protein foods group.
(Response 35) In the proposed rule (87 FR 59168 at 59185), we
stated that for individual foods, the nutrient content of beans, peas,
and lentils is similar to foods in both the protein foods group and in
the vegetable group and may be counted under either food group.
Similarly, for combination foods, we proposed that beans, peas, and
lentils could be counted as either a protein food or as a vegetable in
a combination food (87 FR 59168 at 59191). Our position has not changed
on beans, peas, and lentils and these foods can be considered under
either of those food groups to qualify for the claim in this final
rule. For consideration as vegetables, the FGEs for beans, peas, and
lentils is \1/2\ c-eq per RACC and for consideration as protein foods,
the FGE is 1 oz-eq per RACC, consistent with the Dietary Guidelines,
2020-2025 (Sec. 101.65(d)(3)(ii)).
The daily recommendation for protein foods in the Healthy U.S.-
Style Dietary Pattern at the 2,000-calorie level is 5\1/2\ oz-eq. For
all the food groups, we calculated the FGE by dividing the daily amount
by four eating occasions (5\1/2\ oz equivalents of protein foods
divided by four is 1\3/8\ oz-eq). For the beans, peas, and lentils sub-
category of protein foods, we set the FGE at 1 oz-eq, which is lower
than 1\3/8\ oz-eq. We proposed rounding down to 1 oz-eq to increase the
number of products containing these subgroups that would be eligible to
bear the claim, consistent with the Dietary Guidelines, 2020-2025,
which encourages consumption of such products (87 FR 59168 at 59188).
The rule maintains the 1 oz-eq FGE for beans, peas, and lentils as it
provides
[[Page 106087]]
sufficient flexibility for a variety of options of nutrient-dense
protein foods, including pulses, to be eligible for the claim, which
may help consumers identify foods that help them meet the daily
recommended amount of protein foods. We decline to include protein
isolates and concentrates when calculating what meets the FGE
requirement for the protein group. The Dietary Guidelines, 2020-2025
recommends following a healthy dietary pattern with a focus on meeting
food group needs by consuming a variety of nutrient-dense foods and
beverages and staying within calorie needs. Although the Dietary
Guidelines, 2020-2025 includes soy protein isolates and concentrates
among examples of foods in the protein foods group, these components
will not count toward meeting the FGEs for the protein foods group in
the rule. The food group approach to the ``healthy'' claim represents a
shift from focusing on individual nutrients to nutrient-dense foods.
Nutrients that are extracted from foods, such as isolates and
concentrates, are not whole, nutrient-dense foods but rather,
individual nutrients such as those included in the original definition
for the ``healthy'' claim. Because of the shift in the framework toward
foods rather than individual nutrients, counting isolated or
concentrated protein toward the protein FGEs would not be consistent
with the ``healthy'' claim's focus on nutrient-dense foods that serve
as the foundation of healthy dietary patterns. The presence of
extracted components, such as isolates or concentrates, and information
about any potential benefits, however, may be useful to consumers and
manufacturers may communicate this information in other ways, (e.g.,
nutrient content claims, health claims, and other truthful and non-
misleading statements on the label).
(Comment 36) One comment asks that FDA provide additional guidance
about converting all forms of pulses into c-eq as a vegetable or into
ounce equivalents as protein. The comment mentions that the proposed
rule does not include information regarding how to account for changes
in volume from processing such as milling, grinding, chopping,
pureeing, dehydrating, and cooking, and asks FDA to provide calculation
guidance to help in determining compliance with the FGE criteria.
(Response 36) We provide information about available resources to
support determination of FGE amounts in Response 12. For example, the
FPED provides c-eq for beans and provides amounts for different forms
such as cooked, uncooked (dry), and canned (Ref. 3). For varieties of a
food that are cut pieces of the whole form, as with beans that are
chopped, sliced, or ground, the total amount of food in a c-eq of whole
food and the cut food would be the same. As noted in Response 12, the
final rule sets a compliance date that is 3 years from the effective
date, and we intend to provide additional resources to help
manufacturers comply with the final rule before the end of the
compliance period.
(Comment 37) One comment requests additional clarity regarding
plant-based foods, including how ingredients like chickpea powder or
legume powder would be treated and whether pea milk, almond milk, and
other plant-based milks, whether fortified or not, would be considered
protein foods.
(Response 37) Powders of protein products, such as chickpea powders
or legume powders, can be included in FGE calculations provided that
the powders are essentially the dried/dehydrated and ground forms of
the original, whole food. Powders that have ingredients added to them
or components of the food removed from them (other than water) would
not be considered a form of the original food for the purposes of the
``healthy'' claim. The FPED provides an example for legumes,
specifically soy flour, which has a 1 oz-eq of \1/2\ oz (~14 g) (Ref.
3). Plant-based milk alternatives, such as pea milk or almond milk,
would be evaluated against the criteria for the dairy food group and
not the protein foods group and are discussed in the dairy section
V.C.6 (``FGEs for Dairy'').
(Comment 38) A number of comments seek clarification as to whether
coconut is considered a nut. One comment mentions that coconut is
currently classified as a tree nut under the Food Allergen Labeling and
Consumer Protection Act and provides that the saturated fat of a
coconut is inherent to the coconut, as is the case with nuts. Other
comments note that they are excluding coconut from their discussion of
nuts and seeds (and would not support exclusion of saturated fat
content of coconut from the overall saturated fat limit, as was
proposed for nuts and seeds) because coconut is unusually rich in
saturated fat.
(Response 38) While a coconut is botanically a fruit (specifically,
a fibrous one-seeded drupe), the Dietary Guidelines, 2020-2025 does not
include coconuts in the nut or the fruit category. In addition, the
FPED database used in the modeling of the U.S. Food Patterns describes
the ``Nuts and Seeds'' category as ``Peanuts, tree nuts, and seeds;
excludes coconut'' (Ref. 3). Instead, the FPED considers coconuts to be
solid fats, listing coconuts with other examples of solid fats as
``Coconut meat, raw--Raw coconut meat containing 33.5 grams of fat per
100 grams.'' Because coconut meat contains total fat amounts of over 33
g per 100 g and most of the fat is saturated (29.7 g per 100 g) (Ref.
7), we have determined that coconuts will not be counted as
contributing toward the protein foods group (i.e., will not be
considered a nut) or the fruit food group, consistent with the Dietary
Guidelines, 2020-2025.
(Comment 39) Many comments request that FDA enable protein foods
with small serving sizes to meet the definition of ``healthy.'' One
comment notes that there are a number of nutrient-dense pulse products,
such as hummus and roasted chickpeas, that would fall into the
``individual foods'' category but have small RACC serving sizes. The
comment asserts that even though these foods provide important
nutrients like dietary fiber and protein while providing minimal
amounts of added sugar, saturated fat, and sodium, it is mathematically
impossible for these small serving sizes to provide the minimum amounts
of food groups required by the proposed rule criteria. The comment
requests that FDA create a pathway for nutrient-dense foods with small
RACCs and serving sizes to meet the definition of ``healthy.'' The
comment mentions this could be achieved by allowing products with small
RACCs and serving sizes that meet the maximum limits for added sugar,
saturated fat, and sodium, to meet the ``healthy'' definition if their
first listed ingredient is an NTE. The comment mentions another
approach would be to require a smaller amount of FGE for these smaller
sized products, such as \1/4\ FGE.
(Response 39) As discussed in Response 8, we do not intend to
exclude nutrient-dense foods consumed in small amounts that are
recommended for healthful dietary patterns, including certain protein
foods. The final rule includes criteria specific to foods with small
RACC sizes in Sec. 101.65(d)(3)(iii)(B). Under the small RACC
criteria, foods with a small RACC size (<=50 g) need to meet the
criteria per 50 g, which will result in many foods with small RACC
sizes being able to meet the FGE amounts. Additionally, with the
expanded exemption for single-ingredient foods in Sec.
101.65(d)(3)(i), as further discussed in Response 9, many foods with
both larger RACC sizes and small RACC sizes, such as roasted chickpeas,
will automatically qualify for the claim, as long as no other
ingredients except for water are added.
[[Page 106088]]
The comments also mention hummus as a food with a small RACC that
may not be able to qualify for the claim. Hummus, which has a RACC of 2
Tbsp, is a mixed product with a number of ingredients. Mixed products,
such as hummus, would need to meet the applicable FGE amounts in
addition to the NTL criteria to qualify for the claim, as discussed in
section V.E.2 (``Mixed Products'').
(Comment 40) One comment supports FDA's inclusion of soy foods and
soy milk in the rule but requests that we align the rule with FDA's
authorized health claims and qualified health claims under 21 CFR
101.14. The comment notes that many soy foods are not eligible for the
proposed ``healthy'' claim even though they are eligible for FDA
authorized health claims and qualified health claims.
(Response 40) Foods and food components that are the subjects of
health claims that FDA has authorized or for which it considers the
exercise of enforcement discretion have an evidence-based relationship
of risk reduction with a disease or health-related condition and the
language in the health claim communicates this specific relationship.
Although many foods that are the subjects of health claims do meet the
requirements of the ``healthy'' nutrient content claim, not all foods
that are the subject of a health claim are core elements of a healthy
dietary pattern, and therefore would not necessarily qualify to bear
the ``healthy'' claim (see section III. (``Background'') for further
discussion of differences between different nutrition labeling claims).
Whether and how a soy food qualifies for ``healthy'' depends on the
food's specific nutrient profile and role in the diet. Some soy foods,
such as soybeans, qualify under the single-ingredient exemption (see
Response 9). Other foods made from soybeans would be subject to the FGE
amounts and NTL criteria for dairy (e.g., soy milk) or for nuts, seeds,
and soy products (e.g., tofu) to qualify for the ``healthy'' claim.
8. FGEs for Oils
(Comment 41) A number of comments express support for FDA's
proposal to include oils, which includes 100% oils, certain oil-based
spreads (i.e., those whose fat content comes solely from oil), and
certain oil-based dressings (i.e., those containing at least 30% oil
and made from oils that meet the ``healthy'' definition) as a food
group, viewing this as consistent with current nutrition science. The
comments note that the Dietary Guidelines, 2020-2025 does not
categorize oils as a ``food group'' but emphasizes that oils are one of
the six core elements of a healthy dietary pattern and recommends daily
intake objectives for oils like the food groups.
Some comments do not support including ``oils'' as a food group.
The comments express that allowing oils to be labeled as healthy may
unintentionally communicate to consumers that oils are healthy in any
amount and could lead to consumer confusion and overconsumption.
(Response 41) Healthy dietary patterns include foods such as
vegetable oils with unsaturated fats and are lower in foods high in
saturated fats, such as butter, shortening, lard, or coconut oil (Ref.
1). Strategies to shift intakes toward achieving a healthy dietary
pattern include cooking with vegetable oils instead of fats like
butter. Therefore, to reflect these shifts, as discussed in the Dietary
Guidelines, we conclude it is appropriate for certain oils and oil-
based products to qualify for the ``healthy'' claim. We are not,
however, establishing an FGE for oils in foods made with these oils and
oil-based products. We disagree with and are not aware of any
information in the comments or elsewhere supporting the argument that
including oils as a food group for the purposes of this rule may lead
to consumer confusion and overconsumption. We note that we do intend to
address oil consumption in our consumer education efforts related to
the ``healthy'' claim.
(Comment 42) Some comments do not support allowing oil-based
spreads and oil-based dressings to qualify to use the ``healthy'' claim
due to concerns that many of these products contain ultra-processed or
highly processed oil or other ingredients.
(Response 42) Oils are characteristic components of healthy dietary
patterns, and this determination reflects that current dietary
recommendations encourage a shift from use and consumption of saturated
fats, such as in butter and many salad dressings, to spreads and
dressings made predominantly of unsaturated oils. The oils in these
foods may be processed to a greater degree than fats such as butter or
lard; however, healthy dietary patterns which include unsaturated oils
rather than fats high in saturated fats are associated with positive
health outcomes (Ref. 1).
(Comment 43) One comment recommends that the requirement for oil-
based dressing to have at least 30% oil be lowered to a level of 10%
oil.
(Response 43) The replacement of oils for solid fats in the diet is
a key reason for the inclusion of oils as core elements of healthy
dietary patterns. Shifts from solid fats to unsaturated oils are
important strategies for constructing healthy dietary patterns.
Therefore, 100% oils and oil-based dressings and spreads that meet
specific requirements can qualify for the ``healthy'' claim. Foods that
are described as ``oil-based'' for the purposes of the ``healthy''
claim are not intended to identify foods that simply have oils as an
ingredient. Rather, the foods identified as oil-based are intended to
be foods where oil is a primary component. At >=30%, oils would
typically make up the largest component in the food, with the exception
of water. Lowering the oil requirement to >=10%, however, would not
ensure that the food is an oil-based dressing with oils as the largest
component, except for any water present. As discussed in the proposed
rule, we did not set qualifying FGEs for the oils group, but instead,
limit use of the claim to the oils themselves, oil-based dressings, and
oil-based spreads, provided they meet the specified criteria. We
decline to lower the minimum amount of required oil in oil-based
dressings in the rule to 10% oil, consistent with the purpose of the
claim and the Dietary Guidelines, 2020-2025.
9. FGEs for Fruit and Vegetable Powders
(Comment 44) In the proposed rule, we did not consider vegetable or
fruit powders to be vegetables or fruits, respectively, for the purpose
of calculating FGEs. Some comments support this approach. One comment
asserts that vegetable powders should not qualify as vegetables for
purposes of the rule because vegetable powders may be produced or used
in a way that modifies the whole vegetable to an extent that removes
some essential characteristics that are beneficial when consuming the
whole vegetable, which could impact the nutrient content. The comment
notes that diets high in vegetables and fruits are beneficial, in part,
because the vegetables and fruits displace other less healthy foods,
and states that it is unlikely that foods made with vegetable powders
would have the same effect. The comment expresses concern that allowing
a product with no recognizable vegetable in it to bear the ``healthy''
claim would send the wrong message to consumers. Another comment agrees
with the exclusion of vegetable and fruit powders on the basis that
they are often used to create ultra-processed snack foods such as
vegetable sticks, puffs, and other snack foods that the comment
describes as high in fat and salt and low in dietary fiber.
Other comments recommend that fruit and vegetable powders, or
certain fruit and vegetable powders (e.g., those with
[[Page 106089]]
similar nutrient composition as whole fruits and vegetables), be able
to contribute to FGEs. For example, some comments ask that FDA allow
fruit and vegetable powders that are not derived from juice to
contribute to the fruit and vegetable food groups and ask that FDA
provide guidance for calculating FGE contributions from fruit and
vegetable powders. Several comments provide information or data
demonstrating that different fruit and vegetable powders have similar
nutrient composition as whole fruits and vegetables. For example, one
comment provides an assessment of fresh, dried, and powdered legumes to
support the inclusion of powdered fruits, vegetables, and legumes under
the ``healthy'' definition. The comment relies on data from the USDA
Standard Food Database to demonstrate that the nutritional composition
of whole chickpeas, black beans, and navy beans are substantially
similar to the powdered forms. The comment provides that chickpea
flour, meal, and grits contain more protein and higher dietary fiber
levels than a whole, raw chickpea, and mentions that USDA reports
similar results for black beans and navy beans. The comments also note
that FDA has recognized in its guidance, Nutrition and Supplement Facts
Labels: Questions and Answers Related to the Compliance Date, Added
Sugars, and Declaration of Quantitative Amounts of Vitamins and
Minerals, that fruit and vegetable powders that are not made from
juices ``are essentially whole fruits and vegetables that have been
processed to change the physical form of the fruit or vegetable to
remove moisture.''
One comment supports the inclusion of dried juice powder if 100%
juice counts toward the FGEs but provides no data or information to
support their recommendation.
(Response 44) In the proposed rule (87 FR 59168 at 59185), we
stated that we would consider concentrated vegetable and fruit purees
and pastes to be vegetables and fruits for the purpose of calculating
FGEs because these products are essentially whole vegetables and fruits
that have been processed to change the physical form of the vegetable
to remove moisture. We did not include vegetable and fruit powders for
the purpose of calculating FGEs because of the potential for these
products to be produced or used in a way that modifies the vegetable or
fruit to an extent that removes some essential characteristics that are
beneficial when consuming the whole vegetable or fruit, which could
impact nutrient content. However, we asked for comment regarding
whether vegetable and fruit powders should be included for the purposes
of FGE calculations, and in particular, any data regarding whether
vegetable powders have similar or different nutrient content, or
similar or different roles in a healthy dietary pattern, compared to
whole vegetables. Comments to the proposed rule describe methods of
vegetable and fruit powder production which are essentially only
changes to the form and removal of moisture, and thus are similar to
the production of purees and pastes. Information provided in the
comments shows that the nutrient content of dried and ground powders is
similar to the nutrient content of whole, fresh (or dried) varieties of
vegetables and fruits. Comments did not provide any information about
the processing of powders made from juices or the nutritional
composition of powders made from juices.
We disagree that labeling foods with vegetable or fruit powders as
``healthy'' will send the ``wrong message'' to consumers. Foods that
qualify for the ``healthy'' claim through the use of vegetable and
fruit powders, including processed foods, will meet the minimum FGE
requirements of either vegetables or fruits and will not exceed the NTL
amounts. Therefore, foods that contain vegetable and fruit powders and
bear the ``healthy'' claim will be nutrient-dense foods. Nutrient-dense
whole vegetable and fruits in powdered form, or products that contain
them, can also displace other ingredients or foods in the diet that are
not nutrient-dense.
For this reason, we conclude that vegetable and fruit powders that
are produced by drying whole vegetables and fruits and grinding into
powder form may be considered in calculation of the vegetable and fruit
FGEs. We are aware that some powders made from 100% juice could be less
nutrient dense, such as juice powders made with carrier agents or
drying aids like maltodextrins (see Food Labeling; Declaration of
Ingredients; Common or Usual Name for Nonstandardized Foods; Diluted
Juice Beverages Final Rule (58 FR 2897 at 2917, January 6, 1993)).
Therefore, powders made through methods with ingredients that are added
or taken away, such as powders made from 100% juice or juice
concentrate with the addition of maltodextrin, may not be considered in
the calculation of vegetable and fruit FGEs. We also address powders of
protein products, such as chickpea powders or legume powders, in
Response 37. We state that those powders can be included in FGE
calculations provided that the powders are essentially the dried/
dehydrated and ground forms of the original, whole food. These specific
foods (beans, peas, lentils, soy, etc.) can also be considered under
the vegetable group as vegetable powders.
10. Other Comments on Food Groups
(Comment 45) Some comments discuss the health benefits associated
with plant-based foods marketed as alternatives for other types of
foods and recommend that FDA create a separate food group for such
plant-based foods and beverages.
(Response 45) There are a number of plant-based foods marketed as
alternatives for other types of foods, e.g., soy-based milk
alternatives or bean-based patties marketed as hamburger alternatives.
As discussed in the section V.C.6 (``FGE for Dairy''), plant-based milk
alternatives are subject to the criteria for the dairy food group.
Other plant-based alternatives to animal-derived foods, though, vary
widely in scope, and are not all similar in content, use, or nutrition.
These plant-based alternatives to animal-derived food products are
being modeled after many different types of animal-derived foods,
including hamburgers, chicken nuggets, hot dogs, ground beef, or fish.
The components of plant-based alternatives to animal-derived foods are
broad and range from vegetables and fruits, to grains, and to other
protein sources, such as beans and nuts. Because of the wide variation
among products, it would not be appropriate to consider all plant-based
foods marketed as alternatives for other types of food under the same
criteria. These products should be considered based on the criteria for
their individual ingredients. For example, plant-based alternatives to
animal-derived foods that are primarily bean-based would be considered
under the protein foods or vegetable food groups. Plant-based
alternatives to animal-derived food products also could be considered
under the criteria for the categories of combination foods if the
products meet the requirements (e.g., a plant-based patty made of beans
and grain ingredients that meets the ``healthy'' criteria for a mixed
product). Therefore, we do not agree that a separate food group with a
different set of criteria should be created for all plant-based foods
and beverages marketed as alternatives to other types of food. This
approach would be inconsistent with the Dietary Guidelines, 2020-2025,
which does not have a separate food group for such plant-based foods
and beverages. We are also aware of ongoing efforts in the innovation
of meat-alternative products with novel protein ingredients from a
variety of sources beyond plant-based
[[Page 106090]]
proteins. Novel ingredients derived from alternative sources, like
mycoprotein and algae, may not fit into the categories of food groups
established by the Dietary Guidelines. As efforts toward innovation
move forward, we intend to monitor the marketplace and will address
issues related to use of ``healthy'' on such products in the future, if
necessary.
(Comment 46) One comment recommends adding food groups to
encourage, instead of NTE, which, according to the comment, would
include groups that have nutritional value, for which current intakes
are minimal, or that are linked to decreased chronic disease risk. The
comment mentions fruits, vegetables, whole grains, and the subgroup
beans, peas, and lentils as candidates for the food groups to
encourage. The comment asserts that food groups and subgroups to which
``automatic healthy status'' has been granted should be given a special
designation, beyond ``healthy,'' ``to distinguish them from foods that
were not granted automatic status and to emphasize their prioritization
in healthy dietary patterns.''
(Response 46) We agree with the inclusion of food group
requirements instead of requirements for NTE in the definition of
``healthy,'' as further discussed in section V.D.6 (``Nutrients to
Encourage''). As described by the Dietary Guidelines, 2020-2025, a
healthy dietary pattern ``consists of nutrient-dense forms of foods and
beverages across all food groups, in recommended amounts, and within
calorie limits.'' The criteria established for the definition may vary
for individual foods from different food groups and there are foods
which fall under the rule's single-ingredient exemption (see Response
9). However, all foods that are able to bear the ``healthy'' claim are
foods that are particularly useful in helping consumers to create
healthy dietary patterns, which is the purpose of the claim. Therefore,
we disagree that certain foods that qualify for the claim should be
given any special designations above other qualifying foods.
(Comment 47) One comment notes that the proposed rule does not
include provisions for communicating how many servings or FGEs of
fruits, vegetables, dairy, protein foods, or grains to incorporate into
a daily pattern, and does not include a mention of staying within
caloric requirements, both of which are recommendations of the Dietary
Guidelines. The comment provides that, even if an individual were to
only purchase and consume foods labeled ``healthy,'' they may not
achieve a healthy pattern if these foods are not consumed in the
appropriate portions for each food group and within calorie limits. The
comment suggests that additional on-pack communications, in addition to
the term ``healthy,'' could help consumers identify how these foods fit
into a healthy pattern.
(Response 47) The purpose of a ``healthy'' claim is to serve as a
quick signal to highlight foods that, based on their nutrient levels,
are particularly useful in building healthy dietary patterns. While we
agree that consumer education is an important part of implementing the
``healthy'' final rule, we have determined that it would not be
appropriate to require educational information about the ``healthy''
claim or how to achieve healthy dietary patterns on food labels due to
the limited space available and other label requirements. Information
and education on healthy dietary patterns are readily available to
consumers through various resources, including the Dietary Guidelines
and related resources, such as the MyPlate education initiative at
<a href="http://MyPlate.gov">MyPlate.gov</a>. Further, we plan to undertake consumer education efforts
related to the ``healthy'' claim, which could include highlighting the
importance of staying within daily calorie limit recommendations and
choosing a variety of nutrient-dense foods within and across different
food groups and subgroups--two concepts that are an integral part of
the Dietary Guidelines, 2020-2025. Additionally, the Nutrition Facts
label includes information about how certain nutrients fit into the
total daily diet. For these reasons, we decline to require additional
information on labels about ``healthy'' and healthy dietary patterns,
although manufacturers are free to include additional truthful and non-
misleading information voluntarily.
(Comment 48) Some comments note that the Dietary Guidelines, 2020-
2025 recognizes that dietary supplements are useful for individuals who
cannot otherwise adequately obtain their nutrient needs or have
different nutritional needs. The comments ask that FDA exempt dietary
supplements from the ``healthy'' nutrient content claim requirements.
One comment asserts that dietary supplements are outside the scope
of the ``healthy'' implied nutrient content claim rule because,
according to the comment, dietary supplements are, by definition,
intended to supplement the diet and are not represented as conventional
foods. The comment requests that if dietary supplements are not
exempted from the ``healthy'' implied nutrient content claim criteria,
then FDA either exercise enforcement discretion related to dietary
supplements or establish parameters that would permit dietary
supplements to bear the ``healthy'' claim. Another comment seeks
clarification as to whether a dietary supplement that does not meet the
``healthy'' claim criteria may still bear the word ``healthy'' as part
of a claim related to a products' ability to maintain a healthy
structure or function or an otherwise lawful dietary supplement claim.
(Response 48) The proposed rule did not exclude dietary supplements
from our definition (87 FR 59168 at 59176). However, as explained in
the proposed rule, current nutrition science reflects the view that
``good nutrition does not come from intake of individual nutrients (as
dietary supplements often provide) but rather from foods with their mix
of various nutrients working together in combination'' (id.).
Consistent with this scientific understanding, the ``healthy'' claim is
intended to highlight those foods that are particularly useful in
constructing healthy dietary patterns, which includes food choices from
across the different food groups, and we have included FGE requirements
to update the claim definition to focus on such foods. Because this is
the intent of the claim, we decline to exempt dietary supplements from
the ``healthy'' criteria. However, dietary supplements may bear
nutrient content claims, including ``healthy,'' if they meet applicable
criteria. Under some circumstances, a dietary supplement product may
use the term ``healthy'' as part of a structure/function claim, without
being subject to the requirements of the ``healthy'' nutrient content
claim (see Response 123).
(Comment 49) Some comments request that medical foods and foods for
special dietary use (FSDU) be exempted from the requirements of the
``healthy'' claim. One comment states that, historically, both medical
foods and FSDU have not been subject to the ``healthy'' claim criteria.
According to the comment, medical foods are exempt from nutrient
content claim requirements in Sec. 101.13(q)(4)(ii). The comment also
mentions that Sec. 101.65(b)(6) specifically exempts claims for foods
for special dietary use from implied nutrient content claim
requirements when the claim identifies the special diet of which the
food is intended to be a part; the comment asks FDA to maintain this
exemption. The comment provides that medical foods
[[Page 106091]]
and FSDUs are not intended as conventional foods for use as part of a
healthy dietary pattern, but instead, are intended to supplement the
diet or meet specific nutrition requirements in specific populations.
The comment asserts that medical foods and FSDUs should thus not be
subject to the ``healthy'' claim criteria but instead should be allowed
to use the term ``healthy'' in a nutritional context, provided that the
claim is not otherwise false and misleading.
(Response 49) Medical foods, as defined by section 5 of the Orphan
Drug Act (21 U.S.C. 360ee(b)(3)), are exempt from nutrient content
claim regulations and therefore not subject to this rule (Sec.
101.13(q)(4)(ii)). Our regulations also exempt certain label statements
from FDA nutrient content claim requirements under Sec. 101.13, and
this rule does not alter these exemptions. For example, a label
statement on a food that complies with a specific provision of 21 CFR
part 105 solely to note that a product has special dietary usefulness
relative to a physical, physiological, pathological, or other
condition, where the claim identifies the special diet of which the
food is intended to be a part, is exempt from the requirements in Sec.
101.13 (Sec. 101.65(b)(6)). However, FDA regulations do not include a
general exemption from applicable nutrient content claim labeling
requirements for all foods for special dietary uses. Therefore, foods
for special dietary uses are subject to the rule if manufacturers
choose to include a ``healthy'' nutrient content claim on a label,
unless they meet a specific exemption from the requirements of Sec.
101.13. It would be inconsistent with current nutrition science and
dietary recommendations on building healthy dietary patterns for a food
for a special dietary use that does not meet the requirements of the
``healthy'' claim to bear such claim in a label statement not subject
to an exemption.
D. Nutrients to Limit
1. General Comments
(Comment 50) Many comments express general support for having NTL
as part of the ``healthy'' framework. These comments assert that
nutrient limits combined with FGE requirements better reflect the
overall nutrient content of a food, including how nutrients may work
together to help build a healthy dietary pattern across different food
groups and subgroups, and that the rule's framework is therefore more
consistent with the Dietary Guidelines than the original definition.
However, some comments suggest that the rule's limits for single
``avoidance nutrients'' contradicts the approach of relying on food
groups as a replacement for single favorable nutrients. Other comments
acknowledge that chemically altered and highly processed foods high in
sugar, sodium, and saturated fats should not be considered ``healthy''
due to their association with increased risks related to obesity and
diet-related chronic diseases.
(Response 50) We agree that having limits for saturated fat, added
sugars, and sodium as part of the ``healthy'' claim criteria is
supported by current nutrition science and Dietary Guideline
recommendations. Current intake of saturated fat, sodium, and added
sugars exceed recommended amounts for a majority of people in the
United States. The Dietary Guidelines, 2020-2025 includes four over-
arching guidelines, including: (1) a guideline to focus on meeting food
group needs with nutrient-dense foods and beverages, while staying
within calorie limits (where nutrient-dense foods and beverages are
described as containing vitamins, minerals, and other health-promoting
compounds and containing little added sugars, saturated fat, and
sodium) and (2) a guideline to limit foods and beverages higher in
saturated fat, sodium, and added sugars. Therefore, the updated
``healthy'' framework, consisting of minimum requirements for food
groups as well as limits for saturated fat, sodium, and added sugars,
is consistent with current nutrition science and key recommendations in
the Dietary Guidelines, 2020-2025.
We disagree that having limits for saturated fat, added sugars, and
sodium as part of the ``healthy'' criteria contradicts having minimum
requirements for food groups (i.e., FGE criteria) as a replacement for
minimum requirements for individual beneficial nutrients. Food group
requirements better reflect the array of nutrients that are contained
in a food rather than one individual beneficial nutrient in isolation.
Including limits for saturated fat, sodium, and added sugars, as well
as food group criteria, in the framework for the updated ``healthy''
definition better characterizes the overall nutrient content of foods,
and as mentioned is consistent with current nutrition science and the
Dietary Guidelines, 2020-2025. For further discussion of these topics,
see section V.C (``Food Group Equivalents'') and section V.D.6
(``Nutrients to Encourage'').
(Comment 51) Some comments support the different limits for
saturated fat, sodium, and added sugars, or recommend limits that are
more restrictive, noting that intakes of these nutrients are associated
with adverse health outcomes and that for a majority of Americans,
intakes of these nutrients exceed recommended amounts. However, many
comments raise concerns that the proposed limits are too restrictive.
For example, some comments assert that the proposed limits on saturated
fat, sodium, and added sugars would ``arbitrarily'' disqualify many
foods from using the ``healthy'' claim. Some comments contend that the
proposed limits are so low that, besides whole foods or single
ingredient foods or commodity foods, few products would meet the
proposed criteria. For example, some comments note that healthier
packaged foods and prepared foods often used by consumers would be
excluded from bearing a ``healthy'' claim due to their ``judicious''
amounts of saturated fat, sodium, and added sugars. Another comment
argues that the proposed criteria would force manufacturers of meals
and main dishes that currently qualify for ``healthy'' to drastically
reformulate their products.
(Response 51) Based on data and information received in comments,
current nutrition science, and the Dietary Guidelines, 2020-2025, and
supported by our review of the products available in the marketplace
(Ref. 2), we have made adjustments to some requirements, including to
some of the NTL criteria, which result in more nutrient-dense foods
that are recommended by the Dietary Guidelines, 2020-2025 being able to
qualify for the ``healthy'' claim. Those adjustments are described in
the following sections on saturated fat, sodium, and added sugars.
(Comment 52) Some comments support adjusting NTL based on food
groups and subgroups, asserting that ``some degree of variation by food
group or subgroup is necessary to account for the intrinsic differences
in nutrient content of different food groups and each food group's
contribution to a healthy diet.'' One comment supports the proposed
approach to consider characteristics of the different food groups
instead of a ``one-size-fits-all algorithm'' for updating the
``healthy'' definition, stating that the proposed approach is
consistent with the principles underpinning the Dietary Guidelines that
promote choosing healthy foods from different food groups, which work
together synergistically within healthy eating patterns. In contrast,
other comments argue that criteria should vary based on RACC size,
rather than by food groups, to account for the range of RACC sizes in
the individual/mixed foods category and their contribution to a dietary
[[Page 106092]]
pattern, arguing that there is little variation in the proposed limits
based on food groups (e.g., 0-5% DV for added sugars across food
groups), but considerable variation in RACC sizes in some food groups
(e.g., 5 g to 110 g in the grains food group). Other comments support
having different criteria (e.g., for NTL and food group contributions)
for products with smaller RACCs. The comments note that small RACC
foods contribute meaningfully to the diet, but, in many cases, the
proposed food group requirements are not mathematically possible for
smaller RACC individual/mixed foods because the RACC size is smaller
than the minimum FGE requirement.
(Response 52) We agree that taking into consideration the
characteristics of the different food groups, rather than using a
``one-size-fits-all'' approach, aligns with the framework of the
Dietary Guidelines, 2020-2025 and its emphasis that healthy dietary
patterns are formed by choosing nutrient-dense foods across different
food groups, which vary in the nutrients they provide and can work
together to improve health. Different food groups consist of foods that
vary in their nutrient content and setting the same limit for all food
groups could result in foods with unnecessary excess saturated fat,
sodium, or added sugars being able to bear the ``healthy'' claim or
result in the unnecessary addition of NTL (e.g., saturated fat or added
sugars) to products in some food groups. For example, increasing the
saturated fat limit across all food groups could result in the
unnecessary addition of saturated fat for products in food groups such
as vegetables, which are generally not sources of saturated fat, or
result in the addition of added sugars to fruit products, which are
generally already naturally sweet.
Therefore, we have maintained the proposed approach of adjusting
NTLs across food groups and subgroups for individual foods (Sec.
101.65(d)(3)(iii)) based on considerations such as different nutrient
profiles of the different food groups and subgroups; the Dietary
Guidelines, 2020-2025 recommendations for different food groups (e.g.,
consuming fat-free and low-fat dairy) and for saturated fat, sodium,
and added sugars; and current intakes of different food groups/
subgroups and NTL; and our marketplace review of nutrient-dense foods
(Ref. 2). We have, however, modified the NTL criteria for combination
foods (i.e., mixed products, main dishes, and meals) so that the limits
for saturated fat, added sugars, and sodium are streamlined and are not
dependent on the food groups that make up the combination foods (Sec.
101.65(d)(3)(iii), (iv) and (v)) (as further discussed in section V.E
(``Combination Foods''). We also have included criteria specifically
for foods with smaller RACCs (<=50 g) (Sec. 101.65(d)(3)(iii)) based
on comments to the proposed rule that demonstrate that some nutrient-
dense foods with smaller RACCs are not able to qualify based on the
proposed criteria, which were also supported by our marketplace review
of nutrient-dense foods across different food groups and categories
(Ref. 2). The changes to the NTL criteria for individual foods, as well
as the rationale for those changes, are discussed below in the
individual NTL sections for saturated fat, sodium, and added sugars.
(Comment 53) Some comments support considering the ``food matrix''
(e.g., nutrient and non-nutrient components of foods, as well as
physical structure and form) as part of the ``healthy'' definition, and
say that, without taking the food matrix into consideration, the
proposed NTL could discourage the consumption of certain foods that
contain beneficial nutrients but do not qualify for the claim (e.g.,
full-fat dairy).
(Response 53) The description of nutrient-dense foods in the
Dietary Guidelines, 2020-2025 (e.g., containing little or no added
sugars, saturated fat, and sodium) does not change based on food matrix
components such as physical structure and food form. Therefore, while
we do adjust NTL based on unique considerations for the different food
groups, including some components of the food matrix (such as overall
nutrient profile), we decline to adjust NTL criteria based on other
components of the food matrix such as physical structure, food form,
and non-nutrient components because they do not characterize the
nutrient levels of a food.
(Comment 54) Some comments believe that the approach used for
calculating the criteria for NTL should be the same approach used for
calculating FGE criteria. For example, some comments argue that the
criteria for the NTL, such as added sugars, should be calculated by
dividing the DV by four eating occasions--analogous to the approach
used for calculating FGE criteria--arguing that there is more room for
intake of added sugars, for example, in the daily diet (i.e., without
reaching the daily limit of 50 g for added sugars) than what would
result with the proposed limits.
(Response 54) We decline to use the same approach for setting NTL
as for calculating FGE criteria. FGE requirements are the minimum
amounts of a food from a particular recommended food group that must be
contained in a product for it to bear the ``healthy'' claim, and they
are intended to help consumers identify foods that can help them reach
recommendations for food groups to meet nutritional needs.
In contrast to FGE criteria, NTL criteria are the maximum amounts
of saturated fat, added sugars, and sodium, that foods which bear the
``healthy'' claim can contain, based on recommendations to limit intake
of these nutrients. For the NTL, the goal is to stay below, rather than
achieve, the limit in order to avoid excess intake of saturated fat,
added sugars, and sodium. Consumers eat a variety of foods throughout
the day. This may include multiple foods, which may or may not meet the
``healthy'' criteria, at different eating occasions that provide
saturated fat, added sugars, and sodium. Foods that do not qualify for
the ``healthy'' claim that are consumed throughout the day also serve
as sources of saturated fat, sodium, and added sugars, and may contain
higher amounts of these nutrients (e.g., if they do not meet the
``healthy'' NTL criteria). Consequently, it is not appropriate to
calculate the baseline amounts for the NTL using the assumption that
all foods consumed in a day are foods that qualify for ``healthy,'' and
it is not appropriate to use the same approach for calculating the
maximum amount of added sugars, saturated fat, or sodium as is used for
calculating the minimum amount of FGEs (e.g., dividing the DV by four)
in order for a food to qualify for ``healthy.'' This approach would be
unlikely to help consumers identify foods that are particularly useful
for building a healthy dietary pattern recommended by the Dietary
Guidelines, 2020-2025, and could result in consumers exceeding the
recommended daily limits for these NTL. We therefore decline to change
the approach for calculating the baseline amounts for the NTL (e.g., by
dividing the DVs for the NTL by four eating occasions) as suggested in
the comments. We have, however, modified the proposed adjustments for
NTL for some food groups and discuss these modifications in the
saturated fat, sodium, and added sugars sections below.
(Comment 55) Some comments encourage FDA to set consistent limits
for saturated fat, added sugars, and sodium (i.e., the same percent DV
limit for all three nutrients). For example, one comment suggests that
the proposed baseline limits do not reflect the definition of nutrient
density in the
[[Page 106093]]
Dietary Guidelines where all three nutrients are ``equally addressed.''
The comment suggests that consumers could interpret a higher limit for
one nutrient as indicating that the one nutrient is less of a public
health concern and offered alternative approaches for consideration,
such as <=5% DV for saturated fat, added sugars, and sodium; 8% DV for
saturated fat, added sugars, and sodium; or 10% DV for saturated fat,
added sugars, and sodium.
(Response 55) While we agree that the concepts of limiting
saturated fat, sodium, and added sugars are all part of the definition
of nutrient-dense foods in the Dietary Guidelines, we disagree that the
definition implies that the limits for saturated fat, sodium, and added
sugars must be the same in a nutrient-dense food. There are many
factors that we considered when determining the limits for saturated
fat, added sugars, and sodium, such as dietary recommendations and
current scientific evidence for each, intake of each in the United
States, inherent amounts of each in different foods, their respective
functions in foods, and our marketplace review of nutrient-dense foods
in the food supply (Ref. 2). These factors vary depending on the
nutrient and the food group.
In setting the criteria for NTL, we proposed baseline values for
each nutrient and adjusted the values, as warranted. Different food
groups and subgroups each contain foods that provide a variety of
nutrients, including important nutrients that are underconsumed, and
some naturally contain higher amounts of nutrients that should be
limited. For example, dairy foods provide vitamin D and calcium;
however, they also may contain saturated fat. In contrast, fruits and
vegetables contain minimal or no saturated fat. Using the same
saturated fat criteria across all food groups could result in the
exclusion of foods that provide important nutrients and that are
recommended by the Dietary Guidelines. However, increasing the
saturated fat limit across all food groups could result in the
unnecessary addition of saturated fat for foods in food groups such as
vegetables, which are generally not sources of saturated fat.
Therefore, we decline to use the same percentages to set the saturated
fat, added sugars, and sodium limits. See below for further discussion
of the individual limits that we have determined for saturated fat,
added sugars, and sodium.
2. Saturated Fat
(Comment 56) Several comments express support for the proposed
limits on saturated fat, including the baseline of <=5% of the DV per
RACC and proposed adjustments for different food groups (i.e., <=10% of
the DV per RACC for dairy products, game meats, seafood, and eggs). The
comments support aligning the baseline level with the existing ``low in
saturated fat'' nutrient content claim, and also support adjusting the
limits for certain food groups to allow for naturally-occurring
saturated fat in nutrient-dense foods recommended by the Dietary
Guidelines, 2020-2025 (e.g., low-fat dairy products, lean proteins,
eggs, nuts, seeds, seafood, and certain oils), while ``limiting the
addition of saturated fats to other recommended foods, such as frozen
vegetables in a butter sauce.'' In contrast, some comments express
concern with the proposed saturated fat limits for individual foods of
<=5%, <=10%, and <=20% DV (depending on food group), asserting that the
proposed saturated fat criteria are too strict. Some comments support
the following alternative limits which they assert are largely in
agreement with our proposed saturated fat limits but are based on RACC
size rather than by food group: 5% DV per RACC for individual foods
with a RACC <=30 grams, 10% DV for individual/mixed foods per RACC with
a RACC >30 grams, 15% DV per serving for main dishes, and 20% DV per
serving for meals. The comments argue that the alternative limits would
allow for inclusion of foods with intrinsic saturated fat (e.g.,
protein foods, dairy, seafood, and avocado), while ``retaining a
reasonable cap on overall saturated fat intake.'' Another comment
states that the strict proposed saturated fat limits could deprive
children of sufficient saturated fat, which is necessary for proper
growth and brain development.
(Response 56) In the proposed rule (87 FR 59168 at 59178), we
discuss that consensus reports, as well as the Dietary Guidelines,
2020-2025, recommend limiting saturated fat intake to no more than 10%
of calories per day, based on risk of CVD. The baseline limit for
saturated fat (<=5% DV per RACC) is consistent with the low saturated
fat nutrient content claim (Sec. 101.62(c)(2)). The limits are further
consistent with the limits for most of the individual foods in the
original definition for ``healthy,'' and our marketplace review of
nutrient-dense foods (Ref. 2), as well as comments that we received to
the proposed rule, which did not suggest that the proposed saturated
fat limits overall were too restrictive. As further discussed in
Response 52, we have maintained the approach of adjusting limits for
saturated fat, sodium, and added sugars for individual foods based on
considerations for the different food groups and subgroups. Using a
baseline limit of <=5% DV for individual foods and adjusting the limit
(e.g., increasing the limit to <=10% DV for some food groups and
subgroups (e.g., dairy) results in a variety of nutrient-dense foods
recommended by the Dietary Guidelines, 2020-2025 across food groups
being able to qualify for the ``healthy'' claim, including those with
some inherent saturated fat (e.g., low-fat dairy). As discussed in
Response 52, having the same saturated fat limit across different food
groups could result in foods with unnecessary excess saturated fat
being able to bear the ``healthy'' claim or result in the unnecessary
addition of saturated fat to products in some food groups that are
generally not sources of saturated fat (e.g., fruits and vegetables).
Therefore, we decline to change the baseline limit of <=5% DV for
saturated fat for individual foods, and we decline to adjust the limit
based solely on RACC size for individual foods without incorporating
food group adjustments. We have, however, adjusted the saturated fat
criteria for some food groups and subgroups such that more nutrient-
dense foods encouraged by the Dietary Guidelines, 2020-2025 that
contain inherent or intrinsic s
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