[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Proposed Rules]
[Pages 59168-59202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20975]
[[Page 59167]]
Vol. 87
Thursday,
No. 188
September 29, 2022
Part II
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 101
Food Labeling: Nutrient Content Claims; Definition of Term ``Healthy'';
Proposed Rule
Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 /
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2016-D-2335]
RIN 0910-AI13
Food Labeling: Nutrient Content Claims; Definition of Term
``Healthy''
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
update the definition for the implied nutrient content claim
``healthy'' to be consistent with current nutrition science and Federal
dietary guidance, especially the Dietary Guidelines for Americans
(Dietary Guidelines), regarding how consumers can maintain healthy
dietary practices. This action, if finalized, will revise the
requirements for when the term ``healthy'' can be used as an implied
claim in the labeling of human food products to indicate that a food's
level of nutrients may help consumers maintain healthy dietary
practices by helping them achieve a total diet that conforms to dietary
recommendations.
DATES: Either electronic or written comments on the proposed rule must
be submitted by December 28, 2022. Submit written comments (including
recommendations) on the collection of information under the Paperwork
Reduction Act of 1995 (PRA) by October 31, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 28, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-2335 for ``Food Labeling: Nutrient Content Claims;
Definition of Term `Healthy.' '' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
Submit comments on information collection under the Paperwork
Reduction Act of 1995 to the Office of Management and Budget (OMB) at
https://www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function. The title of this
proposed collection is ``Food Labeling Regulations,'' OMB control
number 0910-0381.
FOR FURTHER INFORMATION CONTACT:
With regard to the proposed rule: Vincent de Jesus, Center for Food
Safety and Applied Nutrition, HFS-830, Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-1450,
[email protected]; or Denise See, Center for Food Safety and
Applied Nutrition, Office of Regulations and Policy (HFS-024), Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2378.
With regard to the information collection: Domini Bean, FDA PRA
Staff, Office of Operations, Food and Drug Administration, Three White
Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852,
301-796-5733, [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
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D. Costs and Benefits
II. Introduction
III. Table of Abbreviations/Commonly Used Acronyms in This Document
IV. Background
A. Regulatory History
B. Need To Update ``Healthy''
C. Actions Taken To Update ``Healthy''
D. Table of Past Publications Referenced in This Proposed Rule
V. Legal Authority
VI. Proposed Action
A. Overview of Approach
B. Description of Proposed Regulation
VII. Proposed Effective and Compliance Dates
VIII. Preliminary Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. Consultation and Coordination With Indian Tribal Governments
XIII. References
I. Executive Summary
A. Purpose of the Proposed Rule
Consumers rely on food labels when navigating the marketplace to
make informed choices about the foods that are the foundation of a
nutritious diet for both themselves and members of their families. FDA
plays an important role in ensuring labels of food for human
consumption are accurate, truthful, and not misleading, including
claims that appear in product labeling to market a food. One such claim
that FDA has regulated is the term ``healthy'' on product labels. Since
1994, we have recognized that when a manufacturer uses labeling that
describes a product as ``healthy'' in the nutritional context, it is
making an implicit claim of the level of nutrients of the product. In
particular, such a label implies that the nutrient content of the food
may help consumers maintain healthy dietary practices. Given that
nutrition science has evolved since the 1990s when FDA first
established a definition for the implied nutrient content claim
``healthy,'' the proposed rule would update the definition for the
implied nutrient content claim ``healthy'' to be consistent with
current nutrition science and Federal dietary guidance. The proposed
rule would revise the requirements for when the claim ``healthy'' can
be used as an implied nutrient content claim in the labeling of human
food products. In particular, because the claim indicates that a food,
because of its nutrient content, may help consumers maintain healthy
dietary practices, we seek to limit the use of the claim to
circumstances in which the food may help consumers achieve a healthy
dietary pattern that conforms to current nutrition science and Federal
dietary guidance.
B. Summary of the Major Provisions of the Proposed Rule
The proposed regulation would update the definition for the implied
nutrient content claim ``healthy,'' which specifies the requirements
for when the claim can be used on human food products. The claim
``healthy,'' when used in the nutritional context in food labeling, is
an implied claim that the levels of the nutrients in the food are such
that the food may help consumers maintain healthy dietary practices.
Under the existing regulation, there are specific criteria for
individual nutrients that must be met in the food for it to bear the
claim, including limits on total fat, saturated fat, cholesterol, and
sodium, and minimum amounts of nutrients whose consumption is
encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and
dietary fiber. Since the time the claim was first defined in 1994,
nutrition science and Federal dietary guidance have changed, making the
current ``healthy'' definition outdated. Our current definition permits
manufacturers to use the claim ``healthy'' on some foods that, based on
the most up-to-date nutrition science and Federal dietary guidance,
contain levels of nutrients that would not help consumers maintain
healthy dietary practices. Further, a number of foods emphasized in
current nutrition science and Federal dietary guidance as key elements
of a healthy dietary pattern are not able to bear the ``healthy'' claim
under the current regulation (e.g., salmon due to fat levels). As a
result, we believe that the definition needs to be updated so that the
use of the claim will again accurately represent that the levels of the
nutrients in the food may help consumers maintain healthy dietary
practices, consistent with current nutrition science and Federal
dietary guidance, as reflected in the Dietary Guidelines for Americans,
2020-2025 (Dietary Guidelines, 2020-2025) (Ref. 1). The proposed
framework for the updated definition of ``healthy'' uses a food group-
based approach in addition to nutrients to limit (based on the
understanding that each food group contributes an array of important
nutrients to the diet). The proposed, updated ``healthy'' criteria
would emphasize healthy dietary patterns by requiring that food
products contain a certain amount of food from at least one of the food
groups or subgroups recommended by the Dietary Guidelines, 2020-2025 in
order to be labeled ``healthy.'' The proposed regulation would also
require a food product to be limited in certain nutrients, including
saturated fat, sodium, and added sugars. The proposed rule would also
add certain recordkeeping requirements for foods bearing the claim
where compliance cannot be verified through information on the product
label.
C. Legal Authority
We are issuing this proposed rule to update the definition of the
implied nutrient content claim ``healthy'' consistent with our
authority in sections 201(n), 403(a), 403(r), and 701(a) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(n), 343(a),
343(r), and 371(a)). We are also relying on our authority under
sections 403(r), 403(a), 201(n) and 701(a) of the FD&C Act to propose
certain records requirements.
D. Costs and Benefits
In the current marketplace, about 5 percent of all packaged foods
are labeled as ``healthy.'' Because nutrition science has evolved over
time, updating the definition of the implied nutrient content claim
``healthy'' to closely align with nutrition science underpinning the
Dietary Guidelines, 2020-2025 will better inform consumers who are
selecting those products to choose a more healthful diet, which may
result in lower incidence of diet-related chronic diseases, including
cardiovascular disease and type 2 diabetes. Quantifiable benefits of
the proposed rule are the estimated reduction over time in all-cause
morbidity stemming from consumers that rely upon the ``healthy''
implied nutrient content claim selecting and consuming more healthful
foods. This is calculated through the negative association between a
Healthy Eating Index score and all-cause mortality. Quantifiable costs
to manufacturers associated with updating the ``healthy'' claim are
reformulating, labeling, and recordkeeping. Discounted at 3 percent
over 20 years, the mean present value of costs is estimated at $276
million, or $19 million annualized. Potential costs of rebranding
certain foods are discussed qualitatively. Discounted at three percent
over 20 years, the mean present value of benefits is estimated at $455
million, or $31 million annualized. Net benefits are estimated at $180
million, or $12 million annualized.
II. Introduction
In 1994, FDA issued a regulation defining ``healthy'' as an implied
nutrient content claim pursuant to the Nutrition Labeling and Education
Act (NLEA) of 1990. Implied nutrient
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content claims were defined in our regulations, in part, as claims that
imply that a food, because of its nutrient content, may help consumers
maintain healthy dietary practices. At that time, nutrition science and
Federal dietary guidance focused more on the individual nutrients
contained in food. As a result, the criteria for ``healthy'' in the
current regulation are solely based on individual nutrients. Nutrition
science and Federal dietary guidance have evolved since the existing
``healthy'' regulation was issued in 1994. As the Dietary Guidelines,
2020-2025 explains, current nutrition science focuses ``on consuming a
healthy dietary pattern'' (Ref. 1). Although nearly all foods can be
incorporated into a healthy dietary pattern to a greater or lesser
extent, current nutrition science emphasizes nutrient-dense foods, such
as fruits, vegetables, and whole grains, as key elements of a healthy
dietary pattern. ``Nutrient dense'' foods and beverages are defined as
foods and beverages that provide vitamins, minerals, and other health-
promoting components and have little added sugars, saturated fat, and
sodium (Ref. 1). These foods, which contain a variety of important
nutrients, work synergistically as part of a dietary pattern to help
improve health (Ref. 1). A number of these nutrient-dense foods are not
able to bear the ``healthy'' claim under the current regulation (e.g.,
salmon due to fat levels). Further, the current definition permits
manufacturers to use the claim ``healthy'' on some foods that, based on
the most up-to-date nutrition science and Federal dietary guidance,
contain levels of nutrients that would not help consumers maintain
healthy dietary practices (e.g., certain ready-to-eat cereals that may
be high in added sugars). Thus, we believe that the ``healthy'' claim
definition needs to be updated in order to ensure that products bearing
the claim are the products that may help consumers maintain healthy
dietary practices, consistent with current nutrition science and
Federal dietary guidance.
FDA seeks to improve dietary patterns in the United States to help
reduce the burden of nutrition-related chronic diseases and advance
health equity as nutrition-related chronic diseases are experienced
disproportionately by certain racial and ethnic minority groups and
those with lower socioeconomic status. We are committed to
accomplishing this, in part, by empowering consumers with more
informative and accessible labeling to choose healthier diets. By
making nutrition information more available to consumers in a direct,
accessible, and consistent manner, consumers will be able to make
informed and healthful dietary choices. A key element in achieving
these goals is updating our policies for nutrition-related labeling
claims to reflect current nutrition science and Federal dietary
guidance, which includes aligning with the updated Nutrition Facts
Label and the Dietary Guidelines, 2020-2025 (Ref. 1), and provide
information in a way that is accessible to consumers. Claims like
``healthy'' provide information to consumers that allow them to quickly
identify foods that can be the foundation of a healthy dietary pattern.
Thus, the goal of this rulemaking is to update the definition of
``healthy'' as an implied nutrient content claim in the labeling of
human food to help ensure that consumers have access to more complete,
accurate, and up-to-date information about those foods.
To provide context regarding the scope of the problem Americans
face from diet-related chronic disease, chronic diseases, such as heart
disease, cancer, and stroke, are among the leading causes of death and
disability in the United States, and half of all American adults have
one or more preventable, diet-related chronic diseases, including
cardiovascular disease and type 2 diabetes (Ref. 2). Each year, more
than 630,000 Americans die from heart disease and close to 600,000 die
from cancer (Ref. 3). An estimated 37 percent of Americans suffer from
cardiovascular disease (CVD) (Ref. 4). As of 2017, 12.2 percent of the
population 18 years and older had diabetes, 33.9 percent of adults had
prediabetes (Ref. 5), and 38.4 percent of the population was predicted
to be diagnosed with cancer during their lifetime (Ref. 6). As noted,
many of these chronic diseases are experienced at higher rates by
certain racial and ethnic minority groups and those with lower
socioeconomic status. For example, in 2017-2018, more than 4 in 10
American adults had high blood pressure, and that number increases to
about 6 in 10 for non-Hispanic Black adults (Ref. 27). Additionally,
from 2017 to 2018, the prevalence of diagnosed diabetes was highest
among American Indian and Alaska Native adults compared to other race-
ethnicity groups (Ref. 28). While chronic diseases result from a mix of
factors, unhealthy dietary patterns throughout the lifespan increase
the risk of developing chronic diseases, along with genetic,
biological, behavioral, socioeconomic, and environmental factors (Ref.
1).
Further, overweight and obesity, which are associated with poor
eating and physical activity behaviors, are major contributors to
chronic disease in the United States (Ref. 10). Obesity raises the risk
for morbidity from chronic diseases such as type 2 diabetes, coronary
heart disease, and some cancers, and is also associated with increased
risk of all-cause and CVD mortality (Ref. 10). More than two-thirds of
U.S. adults and nearly one-third of children and youth are overweight
or obese (Ref. 11). These high rates of overweight and obesity and
chronic disease have persisted for more than two decades and come not
only with increased health risks, but also at high economic cost.
According to the Government Accountability Office, in 2018, $383.6
billion was spent to treat CVD, cancer, and diabetes, making up 25
percent of the approximately $1.5 trillion in total health care
spending on conditions among U.S. adults. In particular, government
payers, including Medicare and Medicaid, account for more than 50
percent of spending for treatment of CVD, cancer, and diabetes (Ref.
29).
Improved nutrition represents an opportunity to help reduce the
rates of these diet-related chronic diseases. As part of our nutrition
work, we are taking actions to help consumers maintain healthy dietary
patterns and make food choices that contribute to such patterns. A key
source that has considered the current nutrition science and
established recommendations on what healthy dietary patterns look like
is the Dietary Guidelines document. The Dietary Guidelines are
developed jointly by the U.S. Department of Agriculture (USDA) and the
U.S. Department of Health and Human Services (HHS) and provide
recommendations on healthy eating and the consumption of foods from
various food groups, as well as the intake of specific macronutrients,
such as saturated fats and added sugars, and micronutrients such as
vitamins and minerals. The Dietary Guidelines are designed for
policymakers and nutrition and health professionals to help all
individuals and their families consume a healthy, nutritionally
adequate diet (Ref. 1). The Dietary Guidelines are the foundation of
Federal dietary guidance and are intended to inform policymakers when
they implement Federal policies and programs related to food,
nutrition, and health. The Dietary Guidelines, in addition to other
consensus reports and scientific information, help FDA to shape
regulations on nutrition-related claims
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and other information that is permitted on a food label.
The Dietary Guidelines, 2020-2025 explains that a healthy
lifestyle--including following a healthy dietary pattern--can help
people achieve and maintain good health and reduce the risk of chronic
disease throughout all stages of the lifespan. The Dietary Guidelines,
2020-2025 identifies vegetables, fruits, dairy, grains, protein foods,
and oils as essential components of a healthy dietary pattern (Ref. 1).
However, more than 80 percent of Americans have dietary patterns that
are low in vegetables, fruits, and dairy (Ref. 1). Additionally, more
than half of the population is meeting or exceeding the total grain and
total protein foods recommendations but is not meeting the
recommendations for the subgroups within each of these food groups
(Ref. 1). In 2019, 42 percent of adolescents and 39 percent of adults
said they ate fruit less than once a day, while 41 percent of
adolescents and 21 percent of adults said they ate vegetables less than
once a day (Ref. 13). At the same time, most Americans exceed the
recommended intake limits for added sugars, saturated fats, and sodium,
nutrients that should be limited in a healthy dietary pattern according
to the Dietary Guidelines, 2020-2025 (Ref. 1). Evidence shows that
excess intake of these nutrients is associated with chronic disease
risk; for example, diets lower in saturated fat may reduce the risk of
CVD (Ref. 7), and high intakes of sodium are directly associated with
elevated blood pressure, an important risk factor for CVD (Refs. 9, 10,
and 17).
As consumers make their food purchases and daily food choices, food
labeling provides them with valuable information about food groups,
nutrients, and how a food from a particular food group fits into their
daily diet. Claims on food packages such as ``healthy'' can provide
quick signals to consumers about the healthfulness of a food or
beverage, making it easier for busy consumers to select foods that can
help build more healthful diets. To be accurate and effective, however,
a claim of ``healthy'' must be based on current nutrition science and
Federal dietary guidance to ensure that the foods bearing the claim in
fact are useful to help consumers maintain healthy dietary practices.
We are thus proposing to update the implied nutrient content claim
``healthy,'' to make it consistent with current nutrition science and
Federal dietary guidance. This update would modernize the criteria for
the ``healthy'' claim to go beyond just individual nutrients to also
incorporate the variety of nutrients present in a food, through the new
food group requirements. This change would better reflect the overall
nutrient content of the food, including nutrient density, to represent
how nutrients work together and make up the food groups and subgroups
that are part of a healthy dietary pattern. Aligning the concept of
what it means to qualify for the ``healthy'' claim with current
nutrition science and Federal dietary guidance, and its focus on
nutrient density, will help ensure that the ``healthy'' claim is
accurate and empowers consumers with information to make healthier
decisions. Because we understand that there may be some reluctance by
some food manufacturers to use the claim with the current regulatory
definition, as it is not consistent with current nutrition science and
Federal dietary guidance, we also expect that our proposed updated
criteria for the ``healthy'' nutrient content claim may expand the
availability of food labeled with the ``healthy'' claim for consumers
in the marketplace due to manufacturers being more willing to use the
updated claim.
III--Table of Abbreviations/Commonly Used Acronyms in This Document
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Abbreviation/acronym What it means
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CVD.......................... Cardiovascular Disease.
Dietary Guidelines........... Dietary Guidelines for Americans.
DV........................... Daily Value.
DRV.......................... Daily Reference Value.
c-eq......................... Cup Equivalent.
DRI.......................... Daily Reference Intake.
DGAC......................... Dietary Guidelines Advisory Committee.
FDA.......................... Food and Drug Administration.
FD&C Act..................... Federal Food, Drug, and Cosmetic Act.
FGE.......................... Food Group Equivalent.
HHS.......................... U.S. Department of Health and Human
Services.
G............................ Gram.
IOM.......................... Institute of Medicine.
OMB.......................... Office of Management and Budget.
National Academies........... National Academies of Sciences,
Engineering, and Medicine.
NFL Final Rule............... Food Labeling: Revision of the Nutrition
and Supplement Facts Labels, Final Rule.
NLEA......................... Nutrition Labeling and Education Act.
oz-eq........................ Ounce Equivalent.
Mg........................... Milligram.
Oz........................... Ounce.
PRA.......................... Paperwork Reduction Act.
RDI.......................... Reference Daily Intake.
RACC......................... Reference Amount Customarily Consumed.
RFI.......................... Request for Information.
PHO.......................... Partially Hydrogenated Oil.
USDA......................... U.S. Department of Agriculture.
Dietary Guidelines, 2020-2025 Dietary Guidelines for Americans, 2020-
2025.
2020 DGAC Report............. Scientific Report of the 2020 Dietary
Guidelines Advisory Committee.
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IV. Background
A. Regulatory History
In the Federal Register of May 10, 1994, we published a final rule
entitled ``Food Labeling: Nutrient Content Claims, Definition of Term:
Healthy'' amending Sec. 101.65(d) to define the term ``healthy'' as an
implied nutrient content claim under section 403(r) of the FD&C Act (59
FR 24232). The definition in Sec. 101.65(d) establishes parameters for
use of the implied nutrient content claim ``healthy'' or related terms
(such as ``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,''
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') on
the label or in the labeling of a food that is useful in creating a
diet that is consistent with dietary recommendations, if the food meets
certain nutrient conditions. Under the existing regulation, these
conditions include specific criteria for nutrients that must be met in
the food for it to bear such claims. These criteria include limits on
total fat, saturated fat, cholesterol, and sodium, and minimum amounts
(10 percent of Daily Value (DV)) of nutrients whose consumption is
encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and
dietary fiber. Under the regulation, foods must meet all limits and
contain the minimum amount of at least one nutrient to encourage to
bear the ``healthy'' claim. The required nutrient criteria vary for
certain food groups (e.g., there are different criteria for seafood,
game meat, and raw fruits and vegetables) (Sec. 101.65(d)(2)). The
current claim is also linked to use with an explicit or implicit claim
or statement about a nutrient (e.g., ``healthy, contains 3 grams of
fat'').
B. Need To Update ``Healthy''
The existing definition in Sec. 101.65(d) is linked to certain
requirements in the Nutrition Facts label at 21 CFR 101.9 and serving
size regulations at 21 CFR 101.12 that were in effect in 1994 when the
final rule to define the nutrient content claim ``healthy'' was
published. For example, the existing ``healthy'' regulation requires
that a product provide a specified percentage of the RDI or Daily
Reference Value (DRV) for nutrients that were of ``sufficient public
health significance to warrant their inclusion on the nutrition label''
(59 FR 24232). Since that time, FDA has issued final rules updating the
Nutrition Facts label and serving size information for packaged foods
to reflect new scientific information. This includes the final rules
``Food Labeling: Revision of the Nutrition and Supplement Facts
Labels'' (81 FR 33742, ``NFL Final Rule'') and ``Food Labeling: Serving
Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion;
Dual-Column Labeling; Updating, Modifying, and Establishing Certain
Reference Amounts Customarily Consumed; Serving Size for Breath Mints;
and Technical Amendments'' (81 FR 34000, ``Serving Size Final Rule''),
which were published on May 27, 2016. These rules included changes to
the nutrients that must be declared on the Nutrition Facts label. For
example, the Nutrition Facts label must now include a declaration of
the amount of added sugars in a serving of a product, based on our
conclusion that evidence on dietary patterns and health outcomes
supports a mandatory declaration of added sugars (81 FR 33742 at
33799). The updates also included changes to the DV of certain
individual nutrients to reflect changes in recommended intake levels
based on current nutrition science. The Nutrition Facts label
declaration requirements and DVs for individual nutrients significantly
inform the regulations for nutrient content claims such as ``healthy,''
including the updated criteria outlined in this proposed rule. The NFL
Final Rule and the Serving Size Final Rule reflect the nutrition
science in the 2015-2020 Dietary Guidelines, other consensus reports,
national survey intake data, and research regarding consumer use and
understanding of the label.
The Dietary Guidelines are published every five years to reflect
current nutrition science. Although some of its specific
recommendations have evolved as scientific knowledge has grown, many of
its foundational recommendations have remained consistent over time
(e.g., recommending increased consumption of fruits, vegetables, and
whole grains, and diets low in saturated fat and sodium). Advancements
in nutrition science have provided a greater understanding of, and
focus on, the importance of healthy dietary patterns, and how dietary
components act synergistically to affect health. The Dietary
Guidelines, 2020-2025 has a particular focus on the importance of
dietary patterns as a whole, with recommendations to help Americans
make choices from across and within all food groups within calorie
needs to add up to an overall healthy dietary pattern (Ref. 1). The
Dietary Guidelines, 2020-2025 also emphasizes ``shifts,'' or
replacement of less healthy food choices with nutrient-dense foods, as
a method for consumers to achieve a healthy dietary pattern. The body
of scientific evidence discussed in the Dietary Guidelines, 2020-2025,
and the recommendations based on that nutrition science, inform this
proposed rule.
As stated above, a key element in helping to reduce the burden of
nutrition-related chronic diseases and advance health equity is
updating FDA's policies for nutrition-related labeling claims to ensure
that they reflect current nutrition science and Federal dietary
guidance, and provide information in ways that are useful and easier to
understand for consumers. Because the implied nutrient content claim
``healthy,'' as codified at Sec. 101.65(d)(2), is linked to the
nutrition labeling regulations and dietary guidance that were in effect
at the time of its issuance in 1994, we propose to update the criteria
for ``healthy'' to ensure they are harmonized with current regulations,
nutrition science, and Federal dietary guidance.
The framework underlying the existing ``healthy'' claim is, in some
respects, inconsistent with current nutrition science and Federal
dietary guidance. For example, the Dietary Guidelines, 2020-2025, which
reflects current nutrition science, is centered on the importance of
dietary patterns; their recommendations focus on the combination of
nutrient-dense foods and beverages that people should consume to meet
nutritional needs within calorie limits (Ref. 1), rather than focusing
on individual nutrients. Nutrient density is important, among other
reasons, because consumption of nutrient-dense foods provides
beneficial nutrients, with little added sugars, saturated fat, or
sodium. In contrast, the existing criteria for ``healthy'' only include
requirements for individual nutrients. Under the solely individual
nutrient-based framework, foods that are encouraged by the Dietary
Guidelines, 2020-2025 for inclusion in a healthy dietary pattern are
sometimes not able to meet the nutrient criteria under Sec. 101.65(d)
for use of the claim ``healthy.'' For example, although consumption of
certain oils, such as olive and canola oil, in place of sources of
saturated fat, is supported by current nutrition science and emphasized
by Federal dietary guidance (such as the Dietary Guidelines, 2020-2025)
as part of a healthy dietary pattern, these oils are currently
ineligible to bear the ``healthy'' claim, in part, because they do not
contain 10 percent of the DV for vitamin A, vitamin C, protein, dietary
fiber, calcium, or iron as specified by the existing rule. Thus, the
existing ``healthy'' claim has become inconsistent with the
longstanding
[[Page 59173]]
purpose of this type of implied claim to indicate that the nutrient
levels in a food may help consumers maintain healthy dietary practices.
To the extent that current nutrition science and Federal dietary
guidance (such as the Dietary Guidelines, 2020-2025) do still focus on
individual nutrients (e.g., recommending limits on saturated fat,
sodium, and added sugars; identifying certain underconsumed nutrients),
there have been some developments in scientific understanding related
to intake of such nutrients. For example, Federal dietary guidance has
shifted from recommending diets low in total fat (Ref. 12) to
emphasizing increased intakes of monounsaturated and polyunsaturated
fats and decreased intakes of saturated fat (Ref. 1). Additionally,
current nutrition science, as reflected in the Dietary Guidelines,
2020-2025, recommends limiting consumption of foods higher in added
sugars, which provide excess calories to the diet without contributing
significant amounts of essential nutrients. In contrast, the existing
``healthy'' criteria include limits on total fat and do not include
limits for added sugars, which makes the criteria inconsistent with
current nutrition science and Federal dietary guidance.
Finally, as noted above, the existing definition for healthy
includes a nutrient contribution criterion focused on nutrients that
had sufficient public health significance to warrant their inclusion on
the nutrition label and that had been highlighted by leading health
authorities as being important to the public health (59 FR 24232 at
24243). At the time the existing ``healthy'' regulation was finalized
in 1994, the nutrients included in the nutrient contribution
requirement were vitamin A, vitamin C, protein, iron, calcium, and
dietary fiber. Nutrient intakes have shifted over time, and vitamins A
and C are no longer considered nutrients of public health significance
because deficiency of these nutrients in the U.S. population is rare
and not currently of substantial public health concern. In our recent
updates to the Nutrition Facts label, we required declaration of
vitamin D and potassium, but no longer required declaration of vitamins
A and C (81 FR 33742 at 33744). These updates are consistent with the
Dietary Guidelines, 2020-2025, which includes calcium, potassium,
dietary fiber, and vitamin D as nutrients of public health concern, in
addition to iron, for certain population groups (Ref. 1). Thus, in
addition to a shift in focus from consumption of individual nutrients
to healthy dietary patterns as the primary way to achieve nutritional
adequacy, there have been some changes in Federal dietary guidance
regarding individual nutrients since the original ``healthy'' rule was
issued.
Noting the changes to the Nutrition Facts label, current nutrition
science, and the Dietary Guidelines, 2020-2025, a variety of
stakeholders, including from academia, industry, and consumers, have
requested that we update the implied nutrient content claim
``healthy.'' Some stakeholders have provided specific recommendations
on how they believe we should approach such an update. For example, in
a citizen petition dated December 1, 2015 (Docket No. FDA-2015-P-4564)
(``Kind Citizen Petition''), KIND LLC requested that we make certain
changes to existing nutrition claim regulations, including a number of
changes specifically related to the nutrient content claim ``healthy.''
C. Actions Taken To Update ``Healthy''
Because the framework for many of our nutrition labeling
regulations is linked to elements in the Nutrition Facts label and
serving size regulations, we have already taken several steps toward
harmonizing the ``healthy'' nutrient content claim with our updated
regulations and current nutrition science. In the Federal Register of
September 28, 2016 (81 FR 66527), we published a notice of availability
of a final guidance entitled ``Use of the Term `Healthy' in the
Labeling of Human Food Products: Guidance for Industry.'' The guidance
describes our intent to reevaluate the existing criteria for
``healthy'' in light of the changes to the Nutrition Facts label and
serving size regulations, as well as the changes in nutrition science
as reflected in the Dietary Guidelines. The guidance also advises
manufacturers of our intention to exercise enforcement discretion with
respect to some of the existing criteria for the nutrient content claim
``healthy'' until we amend Sec. 101.65(d)(2). The guidance is
available at: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf.
Specifically, the guidance advises food manufacturers of our intent
to exercise enforcement discretion with respect to the implied nutrient
content claim ``healthy'' for foods that have a fat profile of
predominantly monounsaturated and polyunsaturated fats, but do not meet
the regulatory definition of ``low fat,'' and on foods that contain at
least 10 percent of the DV per reference amount customarily consumed
(RACC) \1\ of potassium or vitamin D. This guidance reflects the
changes in science and the Dietary Guidelines as described above
related to intake of dietary fat and the changes in the nutrients of
public health concern since the ``healthy'' definition was originally
issued.
---------------------------------------------------------------------------
\1\ Our regulations at Sec. 101.12(b) establish RACCs for
specified product categories that manufacturers can use to determine
the required label serving size.
---------------------------------------------------------------------------
In September 2016, we also announced the establishment of a docket
(Docket No. FDA-2016-D-2335) to receive information and comments
(request for information or RFI) on the use of the term ``healthy'' in
the labeling of human food products (81 FR 66562, September 28, 2016).
In the RFI, we invited interested persons to comment on the Kind
Citizen Petition; the use of the term ``healthy'' as a nutrient content
claim in the labeling of human food products; and when, if ever, the
use of the term ``healthy'' may be false or misleading. We also sought
input on 12 specific questions and asked interested parties to provide
supporting data, consumer research, and other information to support
their comments and answers to our questions. Along with the RFI, we
held a public meeting on March 9, 2017, entitled ``Use of the Term
`Healthy' in the Labeling of Human Food Products'' (Ref. 13). The
purpose of the public meeting was to give interested persons an
opportunity to discuss the use of the term ``healthy'' in the labeling
of human food.
Overall, the comments to the docket (nearly 1,200) and at the
public meeting supported updating the criteria for the ``healthy''
nutrient content claim to reflect current nutrition science and the
Dietary Guidelines. Most health organizations, industry
representatives, and consumers supported an enforceable, specific
definition that would help guide consumers toward healthier options.
There was broad support for limiting certain nutrients, especially
added sugars, in foods labeled ``healthy,'' and in allowing whole,
nutrient-dense foods and foods high in monounsaturated and
polyunsaturated fats to meet the definition. Comments to the docket
provided specific recommendations for nutrient criteria, whole food
servings, and flexibility for different food categories. While there
was some variation in the specific criteria proposed in comments,
virtually all of the proposed frameworks included a combination of
nutrient criteria and food group requirements.
Some comments from consumers, and a few comments from industry and
[[Page 59174]]
health organizations, expressed hesitation at the notion of a
``healthy'' nutrient content claim. Their primary concerns were that
``healthy'' could be too simplistic, could deter consumers from looking
further into a product's nutritional content, could lead to excessive
consumption of ``healthy'' products, or could mean different things to
different consumers (e.g., some consumers may not understand
``healthy'' in a nutritional context, but, rather, as referring to
other aspects of the product, such as its production method (e.g.,
organic)). FDA notes that the claim is not new and has been used on
food product labels for decades, but we welcome additional comments on
these issues in the context of this proposed rule.
We carefully considered comments received in response to the RFI
and are addressing many aspects of the concerns noted within those
comments in this proposed rule. We view the ``healthy'' claim as an
opportunity to signal and provide information to consumers on which
food products, because of their nutrient content, can be most helpful
in maintaining healthy dietary practices, based on current nutrition
science and Federal dietary guidance. The availability of a revised,
updated ``healthy'' claim may also result in some members of the food
industry developing and/or reformulating food products to better match
current nutrition science recommendations and use the claim. Given the
widespread support for updating ``healthy'' along with the need to
align the claim with current nutrition science, we are proposing
updated criteria for the claim.
D. Table of Past Publications Referenced in This Proposed Rule
----------------------------------------------------------------------------------------------------------------
Title Publication date Citation
----------------------------------------------------------------------------------------------------------------
Food Labeling: Nutrient Content Claims, General January 6, 1993............................ 58 FR 2302
Principles, Petitions, Definition of Terms Final
Rule.
Food Labeling: Nutrient Content Claims, Definition May 10, 1994............................... 59 FR 24232
of Term: Healthy Final Rule.
Food Labeling: Revision of the Nutrition and May 27, 2016............................... 81 FR 33742
Supplement Facts Labels Final Rule.
Food Labeling: Serving Sizes of Foods That Can May 27, 2016............................... 81 FR 34000
Reasonably Be Consumed at One Eating Occasion;
Dual-Column Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts Customarily
Consumed; Serving Size for Breath Mints; and
Technical Amendments Final Rule.
Notice of Availability for a Final Guidance ``Use September 28, 2016......................... 81 FR 66527
of the Term `Healthy' in the Labeling of Human
Food Products: Guidance for Industry''.
Request for Information on the Use of the Term September 28, 2016......................... 81 FR 66562
``Healthy'' in the Labeling of Human Food Products.
----------------------------------------------------------------------------------------------------------------
V. Legal Authority
We are issuing this proposed rule to update the definition of the
implied nutrient content claim ``healthy'' consistent with our
authority in sections 201(n), 403(a), 403(r), and 701(a) of the FD&C
Act. These sections authorize FDA to adopt regulations that prohibit
labeling that is: (1) false and misleading in that it fails to reveal
facts that are material in light of the representations that are made
with respect to consequences that may result from consuming the food or
(2) uses terms to characterize the level of any nutrient in a food that
has not been defined by regulation by FDA.
Congress passed the Nutrition Labeling and Education Act (NLEA) of
1990 (Pub. L. 101-535), with three basic objectives: (1) to make
available nutrition information that can assist consumers in selecting
foods that can lead to healthier diets, (2) to eliminate consumer
confusion by establishing definitions for nutrient content claims that
are consistent with the terms defined by the Secretary of HHS, and (3)
to encourage product innovation through the development and marketing
of nutritionally improved foods (58 FR 2302, January 6, 1993). The NLEA
created section 403(r)(1)(A) of the FD&C Act, which provides
specifications for a claim made in the label or labeling of the food
which expressly or by implication characterizes the level of any
nutrient which is of the type required by section 403(q)(1) or (q)(2)
to be in the label or labeling of the food. The statute permits the use
of these label and labeling claims that expressly or by implication
characterize the level of any nutrient in a food, but only if the
claims are made in accordance with FDA's authorizing regulations
(section 403(r)(1)(A) & (r)(2)(A) of the FD&C Act). Such claims are
referred to as ``nutrient content claims.''
Nutrient content claims can either be claims that expressly
characterize the level of a nutrient (express claims, such as ``low
fat'') or claims that by implication characterize the level of any
nutrient (implied claims, like the ``healthy'' claim). Nutrient content
claims are typically based per RACC. This allows nutrient content
claims on foods to be considered consistently across products and
product sizes. In rulemaking to implement section 403(r)(1)(A) and
403(r)(2) of the FD&C Act shortly after the enactment of the NLEA, we
determined that a claim that states that a food, because of its
nutrient content, may be useful in maintaining healthy dietary
practices is a claim that characterizes the levels of nutrients in a
food (``Food Labeling: Nutrient Content Claims, General Principles,
Petitions, Definition of Terms,'' 58 FR 2302 at 2374-75, January 6,
1993). That rulemaking resulted in regulations defining ``implied
nutrient content claims,'' in part, as claims that imply that a food,
because of its nutrient content, may help consumers maintain healthy
dietary practices. As the preamble explained, ``[t]he claims are
essentially saying that the levels of nutrients in the food are such
that the food will contribute to good health'' (58 FR 2302 at 2375).
FDA issued another implementing regulation in 1994, in which we
defined ``healthy'' when the term is used as an implied nutrient
content claim (59 FR 24232, May 10, 1994). We explained in the preamble
to the 1994 final rule that the statute requires that FDA define terms
by regulation before they are used as nutritional claims in food
labeling; more specifically, under the terms of section 403(r)(1)(A)
and 403(r)(2) of the FD&C Act, a nutrient content claim would misbrand
a food unless it is made in accordance with a definition of the
Secretary (and, by delegation, FDA) or with one of the other provisions
in section 403(r)(2) of the FD&C Act (59 FR 24232 at 24234). The
preamble explained that FDA had already determined that, when used in
the nutritional labeling context, the term ``healthy'' is making an
implied claim about the levels of the nutrients in the food; that is,
that these levels are such that the food would be useful in achieving a
total diet that conforms to current dietary recommendations (56 FR
60421 at 60423, November 27, 1991). Accordingly, FDA was establishing a
[[Page 59175]]
definition for ``healthy'' when it is used in a nutritional context.
In this rulemaking, we are proposing to update the definition of
``healthy'' when used as an implied nutrient content claim based on
developments in current nutrition science and Federal dietary guidance,
as we did with the rulemaking updating the Nutrition Facts label. Our
proposed, updated criteria for ``healthy'' incorporate both food group
and nutrient-to-limit requirements. These changes are intended to
ensure that foods bearing the implied nutrient content claim
``healthy'' are foods that may help consumers maintain healthy dietary
practices, based on current nutrition science and Federal dietary
guidance. The fundamental purpose of this rulemaking furthers the
congressional objectives underlying the NLEA of providing nutrition
information to consumers to help in selecting foods that can lead to
healthier diets and reducing consumer confusion potentially caused by
the use of inconsistent definitions for nutrient content claims.
The proposed revised definition of ``healthy'' is consistent with
the statutory language, particularly in light of the way current
nutrition science and Federal dietary guidance, such as the Dietary
Guidelines, have evolved and built upon previous editions. The Dietary
Guidelines reflect the consensus scientific understanding that
nutrients are not consumed in isolation and focus their recommendations
on consuming a variety of nutrient-dense foods, across all food groups,
as part of a healthy dietary pattern. The statutory language describes
nutrient content claims as claims in the label or labeling of a food
that ``expressly or by implication'' ``characterize the level of any
nutrient in a food'' (section 403(r)(1)(A) of the FD&C Act). The claim
``healthy'' on its face is an implied claim because it suggests that
the food, because of its nutrient content, may help consumers maintain
healthy dietary practices. In the 1994 definition of the claim, levels
for nine different individual nutrients were discussed: fat, saturated
fat, cholesterol, vitamin A, vitamin C, calcium, iron, protein, and
fiber (21 CFR 101.65(d)(2)(i)). As discussed elsewhere in this
document, in recent years the Dietary Guidelines have shifted to
recommending healthy dietary patterns and the consumption of food
groups in certain quantities to achieve adequate nutrient intake, based
on the understanding that each food group contributes an array of
important nutrients to the diet (Dietary Guidelines, 2020-2025).
Specifically, the Dietary Guidelines, 2020-2025 states that because
foods provide an array of nutrients and other components that have
health benefits, nutritional needs should be met primarily through a
variety of nutrient-dense foods. Additionally, the Dietary Guidelines,
2020-2025 recommends increasing intakes of food groups to move intakes
of underconsumed dietary components closer to recommendations.
Accordingly, the new proposed definition includes food groups that
provide a number of different nutrients and is thus characterizing the
overall nutrient content of the food, rather than focusing on one
individual nutrient in isolation, as with an express nutrient content
claim. Each food group that is included in the food group requirement
for the proposed updated definition of the ``healthy'' claim represents
the inclusion of multiple important nutrients. Therefore, the use of
food groups better accounts for how all these nutrients contribute to,
and may work synergistically to create, a healthy dietary pattern and
improve health outcomes. By requiring products to contain a certain
amount of a food group, the proposed rule will help ensure foods
bearing the ``healthy'' claim contain a variety of important beneficial
nutrients and, therefore, help Americans meet recommended nutrient
intakes and maintain healthy dietary patterns. Consistent with
Congress's objectives to provide appropriate nutritional information to
consumers, and based on current nutrition science and Federal dietary
guidance, the statutory phrase ``characterize the level of any nutrient
in a food'' encompasses both limits on certain individual nutrients and
food group criteria that more broadly incorporate a variety of
nutrients from nutrient dense foods which may also have a synergistic
effect.
In addition to section 403(r)(2) of the FD&C Act, we are issuing
this proposed rule under section 701(a) of the FD&C Act, which states
that we may issue regulations for the efficient enforcement of the FD&C
Act and has been interpreted to apply in order to ``effectuate a
congressional objective expressed elsewhere in the Act'' (Association
of American Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204
(D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v. FDA, 484 F. Sup. 1179,
1183 (D. Del. 1980)).
We are also relying on our authority under sections 403(r), 403(a),
201(n) and 701(a) of the FD&C Act, to propose records requirements
designed to ensure that the use of the ``healthy'' claim is accurate,
truthful and not misleading, based on information known only to the
manufacturer, and to facilitate efficient and effective action to
enforce the requirements when necessary. Our authority to establish
records requirements has been upheld under other provisions of the FD&C
Act where FDA has found such records to be necessary (National
Confectioners Assoc. v. Califano, 569 F.2d 690, 693-94 (D.C. Cir.
1978)). The recordkeeping we propose to require applies only to foods
voluntarily bearing the ``healthy'' claim for which an adequate
analytical method to determine food group equivalents is not available
or the amount cannot be discerned from the label alone. The records
would allow us to verify that the product meets the requirements to
bear the claim and that use of the nutrient content claim ``healthy''
is truthful and not misleading. Thus, the proposed records requirements
would help in the efficient enforcement of the FD&C Act (see discussion
in section VI.B.4 ``Records Requirements'' for more information).
The authority granted to FDA under sections 701(a), 403(r),
403(a)(1) and 201(n) of the FD&C Act not only includes authority to
establish records requirements, but also includes access to such
records. Without access to such records, FDA would not know whether the
food meets the proposed requirements to bear the ``healthy'' claim
consistent with section 403(r) of the FD&C Act, and whether the use of
the claim is truthful and not misleading under sections 403(a)(1) and
201(n) of the FD&C Act. The introduction or delivery for introduction
into interstate commerce of a misbranded food is a prohibited act under
section 301(a) of the FD&C Act (21 U.S.C. 331(a)). Thus, to determine
whether a food that is voluntarily bearing a ``healthy'' nutrient
content claim is misbranded and the manufacturer has committed a
prohibited act, we must have access to the manufacturer's records that
we are requiring be kept under proposed Sec. 101.65(d)(4) (21 CFR
101.65(d)(4)). Failure to make and keep records and provide the records
to FDA, as described in proposed Sec. 101.65(d)(4), would result in
the food bearing the ``healthy'' claim being misbranded under sections
403(r) and 403(a)(1) of the FD&C Act.
VI. Proposed Action
We propose to update the ``healthy'' nutrient content claim to
align its criteria with our updates to the Nutrition Facts label and
with current nutrition science and Federal dietary guidance, especially
the Dietary Guidelines, 2020-2025. We also took several additional
factors into
[[Page 59176]]
consideration while developing the proposed, updated criteria for
``healthy.'' We intend for the updated ``healthy'' criteria to help
identify and encourage consumption of nutrient-dense foods to meet
current nutrition science and Federal dietary guidance, especially the
intake recommendations of the individual food groups as discussed in
the Dietary Guidelines, 2020-2025. We also intend for the ``healthy''
criteria to be appropriately flexible to allow for industry innovation,
thereby increasing the availability of foods in the marketplace that
will help consumers meet dietary recommendations. Finally, we based the
proposed criteria on well-established and longstanding foundations of
dietary guidance, including food group recommendations and nutrients to
limit.
A. Overview of Approach
The Dietary Guidelines, 2020-2025 recommends following a healthy
dietary pattern at every life stage with a focus on meeting food group
needs with nutrient-dense foods and beverages, and staying within
calorie limits. Specifically, the Dietary Guidelines, 2020-2025 states
that because foods provide an array of nutrients and other components
that have health benefits, nutritional needs should be met primarily
through a variety of nutrient dense foods. Additionally, the Dietary
Guidelines, 2020-2025 recommends increasing intakes of food groups to
move intakes of underconsumed dietary components closer to
recommendations. Consistent with current nutrition science and Federal
dietary guidance, our proposed, updated criteria for ``healthy'' use an
approach based on both food groups and nutrients to limit, rather than
focusing solely on individual nutrients. The updated ``healthy''
criteria emphasize the food groups and subgroups identified in the
Dietary Guidelines, 2020-2025 as part of a healthy dietary pattern:
vegetables, fruits, grains, dairy, and protein foods, as well as oils.
Under the proposed, updated criteria, food products would need to
contain a certain amount of food (a ``food group equivalent'') from at
least one of these recommended food groups or subgroups (e.g., \1/2\
cup of fruit or \3/4\ cup of dairy) to be labeled ``healthy.'' The
proposed incorporation of food group criteria is consistent with the
current nutrition science articulated in the Dietary Guidelines, 2020-
2025 and its focus on dietary patterns as a whole and is appropriate
for this implied nutrient content claim because claims that imply a
food product contains a certain amount of a food group would
characterize the level of a variety of nutrients important to help
consumers maintain healthy dietary practices.
In addition to the food group criteria, we are proposing that foods
must continue to adhere to certain criteria regarding nutrients to
limit to be labeled ``healthy.'' Specifically, we propose maintaining
sodium and saturated fat as nutrients to limit (which are already
included in the current criteria), along with adding a limit on added
sugars, consistent with the rationale for the new Nutrition Facts label
requirement for added sugars declaration. These criteria are also
consistent with the Dietary Guidelines, 2020-2025 recommendations to
limit intake of sodium, saturated fat, and added sugars, and, based on
current nutrition science, would strengthen the public health benefits
of foods bearing the ``healthy'' claim. The specific food group
criteria and the nutrients to limit are discussed in further detail in
sections VI.A.1 and VI.A.2 (``Food Groups'' and ``Nutrients to
Limit'').
Because of the proposed food group approach, we propose that the
``healthy'' criteria no longer include minimum amounts of nutrients to
encourage (i.e., nutrients that are underconsumed and whose low intake
in the general population or in individual subpopulations raise public
health concern). The Dietary Guidelines, 2020-2025 recommendations to
consume various food groups and subgroups in certain quantities are
intended to ensure overall nutritional adequacy and consumption in a
manner to help consumers maintain healthy dietary practices. FDA is
concerned that including criteria for nutrients to encourage could spur
fortification to allow foods that are low in saturated fat, sodium, and
added sugars to qualify for the ``healthy'' claim, despite these foods
not contributing to a meaningful amount of a food group (e.g., white
bread fortified with calcium). FDA does not support indiscriminate
fortification of foods but, rather, encourages the rational addition of
nutrients to foods, as discussed further in our fortification policy
guidance (Ref. 30). We request comment on whether nutrients to
encourage should be included in addition to the food group criteria.
As described below, there are some foods that we propose to include
in the updated criteria for ``healthy'' including raw, whole fruits and
vegetables, and water, that under the proposed updated criteria, will
not need to meet requirements for food group equivalents and nutrients
to limit. These foods are included in categories of food that can
automatically use the ``healthy'' claim because of their nutrient
content and positive contribution to an overall healthy diet. This is
not the case for these foods under the current rule; rather the
individual fruit or vegetable must meet the criteria for the nutrients
to limit (total fat, saturated fat, sodium, cholesterol) in order to
bear the ``healthy'' claim. These exceptions will be discussed in
further detail in section VI.B.3 (``Covered Products'').
1. Food Groups
Current nutrition science and Federal dietary guidance specifically
emphasize the importance of following a healthy dietary pattern across
the lifespan (Ref. 1). As described earlier, the Dietary Guidelines,
2020-2025 notes that foods and beverages are not consumed in isolation,
but rather in various combinations over time--a ``dietary pattern.''
Components of a dietary pattern may have interactive, synergistic, and
potentially cumulative relationships, such that the dietary pattern may
be more predictive of overall health status and disease risk than
individual foods or nutrients (Ref. 1). The principal message of the
Dietary Guidelines, 2020-2025 is to follow a healthy dietary pattern
that focuses on meeting food group needs with nutrient-dense foods and
beverages and stays within calorie limits. The recommendations include
an emphasis on meeting nutritional needs ``primarily from foods and
beverages--specifically, nutrient-dense foods and beverages'' (Ref. 1),
as opposed to dietary supplements. While FDA's definition includes
dietary supplements as foods, they may not always be included in what
the nutrition science literature refers to as ``foods.'' This
recommendation also reflects the view that good nutrition does not come
from intake of individual nutrients (as dietary supplements often
provide) but rather from foods with their mix of various nutrients
working together in combination. The Dietary Guidelines, 2020-2025 goes
on to describe that ``[e]ating an appropriate mix of foods from the
food groups and subgroups--within an appropriate calorie level--is
important to promote health at each life stage. Each of the food groups
and their subgroups provides an array of nutrients, and the amounts
recommended reflect eating patterns that have been associated with
positive health outcomes'' (Ref. 1, page 31). This focus on food groups
is consistent with longstanding Federal nutrition education and
messaging structured around food groups, such as those associated with
MyPlate and the former MyPyramid Food Guidance System and Food Guide
Pyramid (Ref. 14).
[[Page 59177]]
The Dietary Guidelines, 2020-2025 further explains that a healthy
dietary pattern includes:
Vegetables of all types--dark green; red and orange;
beans, peas, and lentils; starchy; and other vegetables;
Fruits, especially whole fruit;
Grains, at least half of which are whole grain;
Dairy, including fat-free or low-fat milk, yogurt, and
cheese, and/or lactose-free versions and fortified soy beverages and
soy yogurt alternatives;
Protein foods, including lean meats, poultry, and eggs;
seafood; beans, peas, and lentils; and nuts, seeds, and soy products;
Oils, including vegetable oils and oils in food, such as
seafood and nuts.
In the Dietary Guidelines, 2020-2025 and previous iterations, foods
fit into groups based on how they are consumed, and their nutrient
content, even if this is different from their botanical classification.
For example, a bell pepper is considered a vegetable in the Dietary
Guidelines, 2020-2025 even though it is botanically a fruit.
Additionally, foods from the same source may be categorized differently
depending on how they are consumed. For example, soybean oil is
classified as an oil, but tofu made from soybeans is classified as a
protein food in the Dietary Guidelines, 2020-2025. In considering which
foods contribute to meeting the individual food group requirements, we
are adopting the categorizations used in the Dietary Guidelines, 2020-
2025 to determine the appropriate food group for the food. For example,
in the previously mentioned bell pepper example, the presence of bell
pepper ingredients would contribute to satisfying the vegetable food
group requirements, rather than the requirements for fruit ingredients.
Evidence relied on in the Dietary Guidelines, 2020-2025 shows that
a healthy dietary pattern, as outlined above, is associated with
beneficial outcomes for all-cause mortality, cardiovascular disease,
overweight and obesity, type 2 diabetes, bone health, and certain types
of cancer) (Ref. 1). Specifically, evidence shows that common
characteristics of dietary patterns associated with positive health
outcomes include relatively higher intake of vegetables, fruits,
legumes, whole grains, low- or non-fat dairy, lean meats and poultry,
seafood, nuts, and unsaturated vegetable oils, and relatively lower
consumption of red and processed meats, sugar-sweetened foods and
beverages, and refined grains (Ref. 1).
The existing criteria for ``healthy'' at Sec. 101.65(d)(2) include
minimum content thresholds for a limited number of nutrients for which
consumption is encouraged. These nutrient criteria were originally
included to identify foods that are particularly helpful to consumers
in maintaining healthy dietary practices and achieving dietary
recommendations. Instead of including a limited set of nutrients for
which consumption is encouraged in the definition as surrogates for
recommended food groups and subgroups, we propose to directly
incorporate food groups as criteria in the definition of the claim
``healthy.'' We tentatively conclude that using food groups to
encourage as the criteria for ``healthy,'' rather than a limited set of
nutrients, would better identify foods with the nutrient content that
may help consumers maintain healthy dietary practices, consistent with
current nutrition science and Federal dietary guidance. This approach
is consistent with the Dietary Guidelines, 2020-2025 focus on overall
dietary patterns to ensure that a range of nutrients are consumed at
appropriate levels, rather than on nutrients in isolation. We solicit
comment on this tentative conclusion.
Our proposed criteria for updating ``healthy'' emphasize healthy
dietary patterns by requiring that food products contain a certain
amount of food from a recommended food group to bear the claim
``healthy.'' In this rule, the phrase ``food group'' refers to the
groups of foods recommended in the Dietary Guidelines, 2020-2025, which
include vegetables, fruits, dairy, grains, protein foods, as well as
oils (Ref. 1). The Dietary Guidelines, 2020-2025 does not categorize
oils as a ``food group,'' but they emphasize that oils are one of the
six core elements of a healthy dietary pattern, along with vegetables,
fruits, grains, dairy, and protein foods, and recommend daily intake
objectives for oils, similar to the food groups. Therefore, we will
include oils as a food group for purposes of this rule. However,
because of their specific role in healthy dietary patterns, the
proposed criteria for oils differ from the criteria for other food
groups, as discussed in further detail in section VI.B.3 (``Covered
Products''). In this rule, the phrase ``food group equivalent'' refers
to the amount of a food group that must be contained in a food product
for it to bear the ``healthy'' claim. In this rule, the phrase ``food
group equivalent'' refers to the amount of a food group that must be
contained in a food product for it to bear the ``healthy'' claim.
We used the ``Healthy U.S.-Style Dietary Pattern,'' as described in
table A3-2 in the Dietary Guidelines, 2020-2025 (Ref. 1), using the
2000-calorie level pattern as the reference, to determine the food
group equivalent amounts. We are basing our food group equivalent
recommendations on amounts recommended at the 2,000 calorie level
because 2,000 calories is often used for general nutrition advice and
this reference amount is already used for other purposes in nutrition
labeling. The 2000-calorie level pattern establishes specific daily
food group and subgroup amounts in cup-equivalents (c-eq), ounce-
equivalents (oz-eq), or grams (g), depending on the type of food. Cup-
and ounce-equivalents identify the amounts of foods from each food
group with similar nutritional content. For example, while the
structural forms of whole wheat bread and brown rice are very
different, the Dietary Guidelines, 2020-2025 considers one medium (1
oz) slice of whole wheat bread to be nutritionally similar to one half
cup of cooked brown rice, and both represent an oz-eq of whole grains.
The 2000-calorie level dietary pattern establishes daily amounts for
each food group as follows:
2\1/2\ c-eq of vegetables (comprising recommendations for
vegetable subgroups);
2 c-eq of fruits;
6 oz-eq of grains, of which at least 3 oz-eq should be
whole grains;
3 c-eq of dairy;
5\1/2\ oz-eq of protein foods (comprising recommendations
for protein food subgroups, such as seafood); and
27 g of oils.
In past rulemakings, we have assumed that the typical American
dietary pattern is three meals and one snack per day, i.e., four eating
occasions, not including beverage-only eating occasions (see final
rules on general requirements for health claims and nutrient content
claims in food labeling, 58 FR 2478 at 2495 and 58 FR 2302 at 2379 to
2380). In other words, we assume that individuals generally have four
opportunities in a day to meet the recommended daily food group amounts
in the Healthy U.S.-Style Dietary Pattern, and thereby satisfy their
nutritional needs. Consistent with this assumption, and with our
approach in past rulemakings, our proposed food group equivalents are
based on four eating occasions per day. To determine the amount of a
food group required for an individual food to bear the ``healthy''
claim, we divided the recommended daily food group amounts by four
eating occasions. For example, because the recommended daily amount of
fruit in the 2000-calorie level pattern is 2 c-eq, we determined that
the food group equivalent for fruit would be \1/2\ c-eq
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(i.e., 2 c-eq divided by four). This would mean that a ``fruit
product'' would need to contain \1/2\ c-eq of fruit per RACC (in
addition to other requirements) to meet the proposed criteria for
``healthy.'' While this calculation provided a baseline amount for the
food group equivalent requirements, we adjusted the baseline amount for
certain food groups and subgroups, as warranted, based on
considerations as described in section VI.B.3 (``Covered Products'').
This calculation also informs the food group criteria for combination
foods (foods that contain a meaningful amount of more than one food
group) as will be discussed in section VI.B.3 (``Covered Products'').
We seek comment on this proposed calculation--based on four eating
occasions per day--for the food group equivalent requirement.
2. Nutrients to Limit
While our proposed updates to the ``healthy'' regulation reflect
the importance of the overall nutrient content of foods that build
dietary patterns rather than individual nutrients in isolation, we do
propose keeping certain nutrients to limit as criteria for bearing the
claim ``healthy.'' This is because current nutrition science and
Federal dietary guidance continue to recommend limiting certain
nutrients as a key component in emphasizing healthy overall dietary
patterns. In the NFL Final Rule, we found that nutrition science
supports limiting intake of saturated fat, sodium, and added sugars.
Similarly, the Dietary Guidelines, 2020-2025 includes recommendations
to choose nutrient-dense foods across and within food groups while
limiting foods and beverages higher in added sugars, saturated fat, and
sodium (Ref. 1). Moreover, under the Dietary Guidelines, 2020-2025,
``nutrient dense'' food and beverages are defined as foods and
beverages that provide vitamins, minerals, and other health-promoting
components and have little added sugars, saturated fat, and sodium.
Vegetables, fruits, whole grains, seafood, eggs, beans, peas, and
lentils, unsalted nuts and seeds, fat-free and low-fat dairy products-,
and lean meats and poultry--when prepared with no or little added
sugars, saturated fat, and sodium--are identified as nutrient-dense
foods (Ref. 1). Thus, in addition to the food group criteria for
``healthy,'' we are proposing updates to criteria for nutrients to
limit for saturated fat, sodium, and are proposing to add criteria for
added sugars. The proposed nutrients to limit criteria help ensure that
foods bearing the ``healthy'' claim do not contain excess saturated
fat, sodium, or added sugars, which can increase calories and/or the
risk of chronic disease and therefore diminish the potential beneficial
public health impact of the ``healthy'' claim.
In setting the criteria for nutrients to limit, we are proposing
baseline values for each nutrient and have adjusted the values, as
warranted. Different food groups and subgroups each contain foods that
provide a variety of nutrients, including important nutrients that are
underconsumed and some naturally contain higher amounts of nutrients
that should be limited. For example, dairy foods provide vitamin D and
calcium; however, they also may contain saturated fat. In contrast,
fruits and vegetables contain minimal or no saturated fat. Using the
same saturated fat criteria across all food groups could exclude foods
that provide important nutrients and that are recommended by the
Dietary Guidelines, such as low-fat milk and low-fat cheese. However,
increasing the saturated fat limit across all food groups could
encourage the unnecessary addition of saturated fat for foods in food
groups such as vegetables, which are generally not sources of saturated
fat. Therefore, based on current nutrition science and Federal dietary
guidance, adjustments to the baseline amount for different food groups
allow a variety of foods across recommended food groups to meet the
proposed, updated definition without encouraging unnecessary addition
of saturated fat, sodium, and added sugars. The adjustments made to the
baseline amount for different food groups and subgroups are further
described in section VI.B.3.b (``Individual foods'').
The baseline values are percentages of the DV for each nutrient to
help ensure flexibility and longevity of the ``healthy'' criteria if
the DVs shift in the future. DVs are reference amounts of nutrients to
consume or not to exceed each day. Historically, the DVs established in
regulation by FDA have been based on the nutritional needs of adults
and children 4 years of age and older. However, the recent revisions to
the regulations for the Nutrition Facts label have established DVs
specific to infants up to 12 months of age and to children 1 to 3 years
of age (Sec. 101.9(c)(9)). As discussed earlier, we are proposing that
use of the nutrient content claim ``healthy'' remains limited to adults
and children 2 years of age and older. Therefore, the claim ``healthy''
could appear on foods directed to children 2 to 3 years of age and on
foods directed to adults and children 4 years of age and older. When
determining eligibility for use of the claim ``healthy,'' specifically
whether a food meets the ``percent DV'' criteria for saturated fat,
sodium, and added sugars, the ``percent DV'' criteria will be based on
the set of DVs appropriate for that food. For the majority of foods,
the DVs established for adults and children 4 years of age and older
will be the basis of the nutrient criteria for the claim that are
discussed in the following sections. However, for the subset of foods
specifically directed to children 2 to 3 years of age (e.g., fruit
pouches, toddler snack puffs), the basis of the ``percent DV'' nutrient
criteria are the specific set of DVs established for that age range in
Sec. 101.9(c)(9).
a. Saturated Fat
The current ``healthy'' nutrient content claim regulation includes
limits on saturated fat for all food categories (Sec.
101.65(d)(2)(i)(A)-(F)). Dietary recommendations have long recognized
the well-established relationship between consumption of saturated fat
and its effect on blood cholesterol levels (Refs. 16 and 17). Evidence
shows that replacement of saturated fats with unsaturated fats,
especially polyunsaturated fats, reduces blood total cholesterol and
low-density lipoprotein cholesterol (LDL-cholesterol) concentrations
and, therefore, the risk of CVD (Ref. 16). Evidence shows that
replacing saturated fats with polyunsaturated fats is associated with a
reduced risk of CVD mortality and/or coronary heart disease (CHD) (Ref.
16). Saturated fat is required to be declared on food labels by section
403(q)(1)(D) of the FD&C Act, and we reaffirmed in the NFL Final Rule
that saturated fat declaration is necessary to assist consumers in
maintaining healthy dietary practices (81 FR 33742 at 33786).
The DVs for nutrients are established either as RDIs or as DRVs.
The DRV for saturated fat is 20 grams (for children 1 to 3 years old,
the DRV is 10 grams), which is approximately 10 percent of calories
based on a 2,000-calorie reference intake level (Sec. 101.9(c)(9)). In
the preamble to the proposed NFL rule (79 FR 11879 at 11895, March 3,
2014, Docket No. FDA-2012-N-1210), we discussed how consensus reports
(e.g., Institute of Medicine (IOM) Dietary Reference Intakes (DRI) and
2002 report from the National Cholesterol Education Program of the
National Institutes of Health's National Heart, Lung, and Blood
Institute) continue to recommend saturated fat intakes of no more than
10 percent of calories, based on risk of CVD. We reaffirmed in the NFL
Final Rule that the 20-gram DRV is consistent with scientific evidence
(81 FR 33742 at 33786). Additionally, the Dietary Guidelines have
consistently
[[Page 59179]]
recommended limiting calories from saturated fats. The Dietary
Guidelines, 2020-2025 states that intake of saturated fat should be
limited to less than 10 percent of calories per day by replacing them
with unsaturated fats, particularly polyunsaturated fats. Accordingly,
we propose limiting saturated fat in foods bearing the implied nutrient
content claim ``healthy,'' to ensure that such foods do not contribute
to a dietary pattern that contains excess saturated fat. Many of the
comments on the RFI supported including a limit on saturated fat in
foods bearing the ``healthy'' claim.
For saturated fat, we are proposing a baseline limit of 5 percent
of the DV per RACC (<=1 g for adults and children 4 years of age and
older). This level is consistent with the low saturated fat nutrient
content claim (21 CFR 101.62(c)(2)), and with the saturated fat
criteria for most of the individual foods in the current definition for
``healthy.'' We are also proposing to adjust the baseline limit for
saturated fat, as warranted, based on specific nutrient considerations
associated with the different food groups and subgroups and the Dietary
Guideline consumption recommendations for different food groups. As
discussed in section V.B.3.b (``Individual foods''), we are proposing
the baseline limit for saturated fat (5 percent of the DV per RACC) for
fruit products; vegetable products; grain products; bean, pea, and soy
products; and nut and seed products (excluding saturated fat derived
from nuts and seeds, as discussed in section VI.B.3.b (``Individual
foods''). We are proposing the following adjustments to the baseline
limit for saturated fat, as described further in the discussion of
individual foods below, for certain categories of foods that are core
elements of healthful dietary patterns associated with reducing chronic
disease risk (e.g., low-fat dairy products): 10 percent of the DV for
dairy products; 10 percent of the DV for game meats, seafood, and eggs;
and 20 percent of total fat for oils and oil-based spreads and
dressings.
We are also considering alternatives to the proposed limits on
saturated fat. We are considering an approach using a ratio of
saturated fat to total fat, such as a ratio based on current DVs for
saturated fat and total fat, which are based on 10 percent and 35
percent of daily calorie intake, respectively. The intent of this
approach would be to apply a single ratio across all food groups,
thereby reducing the variation in the currently proposed limits, while
still allowing some flexibility for foods that provide monounsaturated
and polyunsaturated fats. We seek comment on the use of a limit for
saturated fat based on the ratio of saturated fat to total fat,
including any data supporting this approach.
b. Sodium
The current ``healthy'' nutrient content regulation includes limits
on sodium content for all food categories (Sec. 101.65(d)(2)(ii)).
Dietary recommendations have long emphasized reductions in sodium
intake because average population-level intake continually exceeds
recommended levels. As we stated in the NFL Final Rule, evidence
continues to support the association between increased sodium
consumption and blood pressure (81 FR 33742 at 33875). For example, the
National Academy of Medicine (formerly IOM), of the National Academies
of Sciences, Engineering, and Medicine (National Academies), 2005 DRI
Electrolytes Report noted a direct relationship between sodium intake
and increased blood pressure (Ref. 9) and the 2013 National Academies
report entitled ``Sodium Intake in Populations: Assessment of the
Evidence'' (Ref. 8) concluded that a strong body of evidence has been
documented in adults that blood pressure decreases as sodium intake
decreases. The Scientific Report of the 2020 Dietary Guidelines
Advisory Committee Report (2020 DGAC Report) states that sodium intake
is directly related to blood pressure across the lifespan and that
elevated blood pressure contributes to the risk of CVD and stroke,
which are both leading causes of morbidity and mortality in the United
States (Ref. 15).
Reducing sodium intake has also been a consistent recommendation in
the Dietary Guidelines; the Dietary Guidelines, 2020-2025 carries
forward the National Academies' recommendation to limit sodium to less
than 2,300 milligrams (mg) per day--and even less for children younger
than age 14 (Refs. 1 and 17). According to the Dietary Guidelines,
2020-2025, healthy dietary patterns limit sodium to the Chronic Disease
Risk Reduction (CDRR) levels defined by the National Academies--1,200
mg/day for ages 1 through 3; 1,500 mg/day for ages 4 through 8; 1,800
mg/day for ages 9 through 13; and 2,300 mg/day for all other age
groups. However, average intakes of sodium are high across the U.S.
population compared to the CDRR levels. Average intakes for those ages
1 and older is 3,393 mg/day, with a range of about 2,000 to 5,000 mg/
day (Ref. 1). In 2019, the National Academies set the CDRR levels for
sodium based on evidence of the beneficial effect of reducing sodium
intake on blood pressure and risk of CVD and hypertension (Ref. 17).
This most recent evaluation of the evidence reaffirms the 2,300 mg/day
recommended daily limit for those 14 years and older. To reduce sodium
intake to the recommended limits, the Dietary Guidelines, 2020-2025
recommends implementing multiple strategies, including making food
choices in all food groups with less sodium (Ref. 1). We propose to
include a limit on the amount of sodium in foods bearing the nutrient
content claim ``healthy'' to help individuals identify foods that are
consistent with dietary recommendations for sodium. Many comments on
the RFI supported a sodium limit on foods bearing the claim
``healthy.''
The DRV for sodium is 2,300 mg (for children 1 to 3 years old, the
DRV is 1,500 mg). We are proposing a baseline sodium limit of <=10
percent of the DV (currently, 230 mg for adults and children 4 years of
age and older) per RACC for individual foods. This proposed, updated
sodium limit is lower than the limit in the existing criteria for
``healthy'' (480 mg, or about 20 percent of current DV) (Sec.
101.65(d)(2)(ii)). We expect that it is feasible to lower the sodium
level requirement for ``healthy'' due to reductions in sodium in
certain foods and food categories in response to consumer support for
policies to limit sodium content in manufactured foods (Refs. 18 and
19) and to technological progress since the existing definition of
``healthy'' was issued in 1994. Additionally, in October 2021, FDA
published short-term (2.5 year) voluntary sodium reduction targets for
the food industry (Ref. 31). These targets are anticipated to support
gradual sodium reduction in the food supply and increase available
options that are lower in sodium. When selecting the proposed, updated
limit for the ``healthy'' claim, we considered the many functions of
sodium in food, including taste, texture, microbial safety, and
stability. For example, while a baseline limit for sodium of <=5
percent of the DV would be consistent with the proposed saturated fat
and added sugar baseline limits and the low sodium nutrient content
claim, we are concerned that a limit of <=5 percent of the DV for
sodium is not practical at this time. We are proposing to adjust the
baseline values for sodium as warranted, based on specific
considerations of the different food groups and subgroups, as described
below. We seek comment on this approach.
[[Page 59180]]
c. Added Sugars
In the NFL Final Rule, we required the declaration of the amount of
added sugars in a serving of a product after we concluded that evidence
on dietary patterns and health outcomes supports a mandatory
declaration of added sugars (81 FR 33742 at 33799). We determined that
declaration of the amount and percent DV of added sugars in a serving
of a product is necessary to assist consumers to maintain healthy
dietary practices and determine how a serving of a product fits into
the context of their total daily diet (81 FR 33742 at 33804). This
conclusion was based on scientific evidence showing that healthy
dietary patterns characterized, in part, by lower intakes of sugar-
sweetened foods and beverages are associated with a decreased risk of
CVD (Ref. 7). This is consistent with a key recommendation of the
Dietary Guidelines, 2020-2025 to limit foods and beverages higher in
added sugars (Ref. 1). To achieve this recommendation, the Dietary
Guidelines, 2020-2025 recommends that individuals 2 years of age and
older consume less than 10 percent of calories per day from added
sugars.
Current consumption data indicate that most Americans are consuming
more than 10 percent of calories from added sugars (Ref. 16). According
to the 2020 DGAC Report, current intake of added sugars remains high at
267 calories, or 12.7 percent of total calories per day among the total
population ages 1 year old and older (Ref. 16). Evidence shows that
consumption of excess calories from added sugars can lead to a less
nutrient-dense diet. When sugars are added to foods and beverages, the
sugars add calories without contributing essential nutrients. Foods
with added sugars displace other nutrient-dense foods in the diet, and
as the amount of added sugars increase in the diet, it becomes more
difficult to also eat foods with sufficient dietary fiber and essential
vitamins and minerals and stay within calorie limits. Thus, a diet low
in added sugars helps individuals achieve a healthy dietary pattern
through nutrient-dense choices within calorie limits (Ref. 1). Many of
the comments on the RFI and public meeting support limiting the amount
of added sugars permitted in foods bearing the claim ``healthy.''
Consistent with our rationale in the NFL Final Rule and with the
Dietary Guidelines, 2020-2025, we find that it is critical that foods
bearing the implied nutrient content claim ``healthy'' do not
contribute to a dietary pattern that contains added sugars over the
recommended levels. We therefore propose including a limit on the
amount of added sugars in foods bearing the nutrient content claim
``healthy'' to help consumers choose foods that will contribute to a
healthy dietary pattern that is lower in added sugars, consistent with
current nutrition science and Federal dietary guidance. The DRV for
added sugars is 50 g (for children 1 to 3 years old, the DRV is 13 g).
For individual foods, we are proposing a baseline value for added
sugars of <=5 percent of the DV per RACC (<=2\1/2\ g for adults and
children 4 years of age and older). While there is no low added sugars
nutrient content claim, the proposed <=5 percent DV level is consistent
with our approach of using a low in saturated fat claim, which the
Dietary Guidelines, 2020-2025 also recommends limiting to less than 10
percent of calories per day starting at age 2. We are also proposing to
adjust the baseline values for added sugars as warranted, based on
specific considerations of the different food groups and subgroups, as
described in the discussion of individual food groups below. We seek
comment on this approach.
We note that high-intensity (low- and no-calorie) sweeteners are
not considered added sugars by FDA. Additionally, the Dietary
Guidelines, 2020-2025 does not consider high-intensity sweeteners to be
added sugars and do not make any recommendations for those 2 years of
age and older on the intake of high-intensity sweeteners. Therefore,
high-intensity sweeteners are not a factor in this proposed rule. The
Dietary Guidelines, 2020-2025 did note that ``replacing added sugars
with low- and no-calorie sweeteners may reduce calorie intake in the
short-term and aid in weight management, yet questions remain about
their effectiveness as a long-term weight management strategy.'' FDA
reviews high-intensity sweeteners for use in foods based on available
scientific evidence. There is reasonable certainty of no harm under the
intended conditions of use of high-intensity sweeteners because the
estimated daily intake is not expected to exceed the acceptable daily
intake for each sweetener.
d. Nutrients Not Included
(1) Total Fat
In contrast to the existing criteria at Sec. 101.65(d), we propose
removing the limit for total fat in the updated criteria for
``healthy.'' Federal dietary guidance, based on current nutrition
science, has shifted away from recommending diets low in total fat--
which includes saturated fat, trans fat, and unsaturated fat--to focus
instead on the types of fat in the diet due to their different effects
on health outcomes. The Dietary Guidelines, 2020-2025, for example,
includes no key recommendation for intake of total fat, and emphasize
replacing intake of saturated fats with unsaturated fats, particularly
polyunsaturated fats (Ref. 1). The shift away from emphasizing total
fat is also reflected in the NFL Final Rule (81 FR 33742). For example,
the declaration of ``Calories from fat'' is no longer required on the
Nutrition Facts label because current nutrition science supports a view
that the type of fat is more relevant than overall total fat intake in
risk of chronic diseases. Reflecting this shift in science, our
guidance for industry on the use of the term ``healthy,'' published in
2016, advises food manufacturers of our intent to exercise enforcement
discretion for products labeled ``healthy'' that are not low in total
fat, but have a fat profile makeup of predominantly monounsaturated and
polyunsaturated fat (Ref. 19). Therefore, while we propose maintaining
a limit on saturated fat, we are not proposing to include total fat as
part of the criteria for the ``healthy'' nutrient content claim.
(2) Trans Fat
In 2015, we released a final determination that partially
hydrogenated oils (PHOs) which are the primary dietary source of
industrially produced trans fat, are no longer generally recognized as
safe for use in food (80 FR 34650, June 17, 2015) to eliminate the
majority of uses of PHOs. The compliance date for this determination
was June 18, 2018, for most foods, with extended compliance dates in
2020 and 2021 for certain uses of PHOs (83 FR 23358, May 21, 2018). As
a result of this determination, what was previously the primary dietary
source of trans fat has been largely removed from the food supply.
We recognize that there are other sources of trans fat in the food
supply, including refined edible oils and naturally occurring sources
in products from ruminant animals (e.g., meat and dairy). The Dietary
Guidelines, 2020-2025 does not make any recommendations regarding
intake of trans fat but notes that the National Academies recommends
that trans fat consumption be as low as possible without compromising
the nutritional adequacy of the diet. However, because foods that
contain declarable levels of trans fat from sources other than PHOs
typically contain saturated fat as well, we expect that the proposed
saturated fat limits will disqualify most foods containing declarable
levels of naturally
[[Page 59181]]
occurring trans fat from meeting the ``healthy'' criteria (Ref. 20).
Therefore, we are not proposing to include a limit for trans fat in the
updated ``healthy'' criteria because we do not think such a limit is
necessary due to the limits we are proposing for saturated fat in this
rule and due to our other regulatory actions to remove PHOs from the
marketplace. We seek comment on our proposed approach to trans fat,
including any data demonstrating that the saturated fat limit will not
adequately disqualify foods containing trans fat from meeting the
proposed ``healthy'' definition.
(3) Dietary Cholesterol
The Dietary Guidelines, 2020-2025 does not make any recommendations
regarding intake of dietary cholesterol but discuss dietary cholesterol
in conjunction with trans fat and note that the National Academies
recommends that dietary cholesterol consumption be as low as possible
without compromising the nutritional adequacy of the diet. The Dietary
Guidelines, 2020-2025 also notes that the USDA Dietary Patterns are
limited in dietary cholesterol (Ref. 1). Additionally, the 2020 DGAC
Report states that ``[b]ecause dietary cholesterol is found only in
animal-source foods that are typically also sources of saturated fat,
the independent effects on blood lipids and CVD are difficult to
assess. Although, we recognize the importance of limiting dietary
cholesterol, we tentatively conclude that it is unnecessary to include
a limit for dietary cholesterol for the ``healthy'' claim because, as
with trans fat, dietary cholesterol is already sufficiently limited by
the proposed limits for saturated fat.
Dietary cholesterol and saturated fats are found in similar foods,
i.e., foods that are higher in dietary cholesterol, such as fatty meats
and full-fat cheese, which are generally also higher in saturated fats
(Ref. 16). As a result, a dietary pattern low in saturated fat is
typically also low in dietary cholesterol. We therefore expect that the
proposed saturated fat value of 5 percent DV per RACC (or the adjusted
baseline limit for certain foods) will disqualify most foods that
contain more than 60 mg of dietary cholesterol, the current limit under
Sec. 101.65, from meeting the proposed ``healthy'' criteria.
There are a few exceptions, including foods such as eggs and some
shellfish, that contain <=5 percent DV of saturated fat per RACC and
are not low in dietary cholesterol (Ref. 20). However, eggs and seafood
(which includes fish and shellfish) are specifically highlighted in the
Dietary Guidelines, 2020-2025 as being nutrient-dense foods, supplying
nutrients such as choline, vitamin D, and essential fatty acids (Refs.
1 and 17). The Dietary Guidelines, 2020-2025 also found that almost 90
percent of Americans do not meet the recommendations for consumption of
seafood, and specifically recommend shifts within the protein foods
group to increase seafood intake.
Because eggs and seafood are nutrient-dense foods, provide
important nutrients, and are specifically recommended by the Dietary
Guidelines, 2020-2025 for inclusion in a healthy dietary pattern, we
consider that it is appropriate for these foods to meet the updated
``healthy'' criteria. For these reasons, we are not proposing to
include a limit on dietary cholesterol as part of the updated criteria
for ``healthy.'' We seek comments on our proposed approach to dietary
cholesterol, including any data showing that the proposed saturated fat
limit does not adequately limit dietary cholesterol, or any data
indicating that foods containing lower saturated fat levels and higher
cholesterol levels (i.e., seafood and eggs) should not bear the
``healthy'' nutrient content claim.
3. Infants and Children Under Two Years of Age
In developing updates to the criteria for ``healthy,'' we have also
considered whether the proposed definition should be extended to cover
foods targeted to those age groups. Defined nutrient content claims
currently apply to foods intended for adults and children 2 years of
age and older. With the exception of claims on the percent of the
Reference Daily Intake (RDI) for vitamins and minerals, nutrient
content claims currently cannot be made on foods intended specifically
for use by infants and children less than 2 years of age (e.g., jarred
baby foods, fruit pouches, toddler snack puffs) unless the claim is
explicitly provided for in the regulations for each individual claim
(21 CFR 101.13(b)(3)). Thus, as with most other nutrient content
claims, the current definition for the nutrient content claim
``healthy'' does not include provisions for foods intended specifically
for use by infants and children less than 2 years of age.
Our tentative conclusion is to continue to limit the use of the
claim to foods directed to adults and children 2 years of age and
older. As described in section IV.C. (``Need to Update `Healthy' ''),
we relied primarily on the science articulated in the Dietary
Guidelines, 2020-2025 in developing the specific criteria on which to
base the definition of ``healthy.'' Historically, the Dietary
Guidelines have been directed to adults and children 2 years of age and
older. The Dietary Guidelines, 2020-2025 highlights the importance of
encouraging healthy dietary patterns at every life stage, and have
included new recommendations for healthy dietary patterns for infants
and children younger than 2 years of age in this lifespan approach.
Infants and children younger than 2 years of age have specific
nutritional needs that apply to their particular life stages and their
dietary recommendations are different from the recommendations for
other age groups. In our last update to the Nutrition Facts label (81
FR 33742), we established Daily Values (DVs) specifically for infants 7
through 12 months and children 1 through 3 years of age. The science
underlying the recommended intake levels of individual nutrients
demonstrates the specific nutritional needs of infants and children in
this life stage. Evaluating the specific nutritional needs of this
population can help us in determining whether it is appropriate to
extend use of the claim ``healthy'' to foods directed at infants and
children younger than 2 years of age. We intend to consider the
scientific information discussed in the Dietary Guidelines, 2020-2025,
as well as information from other sources, as we evaluate whether
specific criteria can be developed for foods targeted to infants and
children in those age groups for use in the definition of ``healthy.''
Because we are continuing to evaluate the information on the
nutritional needs of this life stage, at this time, we are not
proposing that the updated definition of ``healthy'' apply to foods
targeted to infants and children under 2 years of age.
B. Description of the Proposed Regulation
1. Terms Subject to Definition
``Healthy'' is a broad term that can have connotations beyond the
nutritional properties of a food. This proposed rule would define
``healthy'' as a nutrient content claim only when it is used in a
nutritional context; in other words, the proposed criteria would only
apply when ``healthy'' is used on a label or in labeling and other
information, such as other claims, images, or vignettes, about the
nutrition content of the food is also present somewhere on the
labeling. For example, if the word ``healthy'' is used above a picture
of vegetables or alongside another nutrient claim such as ``0g of
fat,'' that would clearly place it in the nutritional context. If,
however,
[[Page 59182]]
the word ``healthy'' was used on a label to say ``our manufacturing
processes support a healthy planet'' with an adjacent picture of the
earth, that would not be in the nutritional context. Under proposed
Sec. 101.65(d)(1), this regulation would cover labeling claims that
are implied nutrient content claims because they suggest that a food
may help consumers maintain healthy dietary practices because of its
nutrient content, where there is also implied or explicit information
about the nutrition content of the food (other than required
disclosures, such as the Nutrition Facts Label) elsewhere on the label
or in labeling.
We determined in the 1994 rule that the term ``healthy''
constitutes an implied nutrient content claim only when it appears on
the label or labeling of a food in a nutritional context (59 FR 24232
at 24234 to 24235). We first determined that the term ``healthy'' does
not inherently imply the absence or presence of a nutrient in a
particular amount, or that the nutrient content of the food would be
helpful to consumers in structuring a diet that conforms to the Dietary
Guidelines. Rather, such inferences are likely to be drawn only if the
term ``healthy'' is accompanied by additional language or graphic
material or is otherwise presented in a context that explicitly or
implicitly suggests that the food has a particular nutrient content.
Based on this reasoning, we concluded that the nutritional context is a
critical factor as to whether ``healthy'' is used as an implied
nutrient content claim.
We reaffirm our position in the 1994 rule that ``healthy'' is only
an implied nutrient content claim when used in a nutritional context,
as described above. However, we propose some minor revisions to Sec.
101.65(d)(1)(ii) defining implied nutrient content claims. Under the
existing regulation, labeling claims are implied nutrient content
claims when they are made in connection with an explicit or implicit
claim or statement about a nutrient (such as ``healthy, contains 3
grams of fat'').
While we want to ensure that the regulation only reaches claims
that are made in a nutritional context, based on our years of
experience with the current claim, we think the existing language may
be too narrow and not reach all information about nutritional context.
Further, because this proposed rule would expand the criteria for
``healthy'' to incorporate food group requirements in addition to
individual nutrients to limit, we want to ensure that the regulation
encompasses the full range of nutrition information covered by the
rule. Based on these considerations, we propose revising the existing
text to broaden the description of what a nutritional context entails.
We seek comment on the definition of nutritional context provided here.
Specifically, we propose revising Sec. 101.65(d)(1)(i) and (ii) to
appear as Sec. 101.65(d)(1). Proposed Sec. 101.65(d)(1), as revised,
would no longer require that an implied nutrient content claim be used
``in connection with an explicit or implicit claim or statement about a
nutrient.'' Instead, we propose in Sec. 101.65(d)(1) that ``healthy''
constitutes a nutrient content claim where the term ``healthy'' is used
to characterize the food itself and ``where there is also implied or
explicit information about the nutrition content of the food.'' This
clarifies that the information on the label that places use of the
claim ``healthy'' into a nutritional context would not necessarily be
immediately adjacent to the implied nutrient content claim, as in the
``healthy, contains 3 grams of fat'' example. Instead, we propose to
make clear that any information on the label or labeling that puts the
term ``healthy'' into a nutritional context would make ``healthy'' an
implied nutrient content claim when it is used to characterize the
food. For example, where ``healthy'' appears on the front of a cereal
product that is described elsewhere on the label or labeling as high in
dietary fiber (e.g., on the back of the package, or on a website), the
``healthy'' claim would constitute a nutrient content claim under Sec.
101.65(d). There may also be instances where the use of a graphic on
the label of a food bearing ``healthy'' would place the term in a
nutritional context; for example, if the label on a can of beans
labeled ``healthy'' also used the MyPlate symbol (which graphically
puts the food groups together in the context of an overall dietary
pattern, as a translation of the Dietary Guidelines) or other front of
pack labeling (such as the ``Facts Up Front'' labeling program) to
imply that the product meets nutritional needs (Ref. 32). In addition,
some brands include ``healthy'' or related words in their brand name,
which could be considered an implied nutrient content claim if any
other information on the label or labeling puts the term ``healthy''
into a nutritional context--for example, if a food product included
``healthy'' within the brand name also used the ``low sodium'' nutrient
content claim. FDA considers food labels and labeling as a whole and
will consider the context of statements made in labels and labeling to
determine whether a product bears a ``healthy'' implied nutrient
content claim.
We also propose revising the codified text in Sec. 101.65(d)(1) to
no longer require that the accompanying material be a ``claim or
statement about a nutrient.'' It would instead require that it be
``information about the nutrition content of the food.'' This text is
still intended to ensure that the regulation only applies where a
``healthy'' claim is used in a nutritional context. However, it would
not limit the accompanying material on the labeling to phrases
declaring presence/level of a specific nutrient (as in the ``healthy,
contains 3 grams of fat'' example), but include any material stating or
implying that the nutrient content of the food would be helpful to
consumers in structuring a diet that is supported by current dietary
recommendations. For example, if a cereal package bore the claim
``healthy'' as a descriptor of the cereal, and its labeling elsewhere
stated, ``Provides all of your child's essential vitamins and
minerals,'' this would constitute an implied nutrient content claim,
because in that context, the ``healthy'' claim suggests that the
nutrient content of the food would be helpful in structuring a diet
that conforms to current dietary recommendations. Information about the
nutrition content of the food need not make explicit references to
nutrients but can refer to nutrients by implication. For example, if
the label on a food product characterizes food using the term
``healthy'' and elsewhere stated that the product is ``made with whole
grain ingredients,'' or ``made with real fruits and vegetables,'' or
``contains a variety of nuts,'' this would put ``healthy'' in a
nutritional context because the labeling implies that the food should
contain nutrients commonly associated with and contributed by those
food components.
We therefore propose that the updated Sec. 101.65(d)(1) state that
it covers labeling claims that are implied nutrient content claims
because they suggest that a food may help consumers maintain healthy
dietary practices due to its nutrient content, where there is also
implied or explicit information about the nutrition content of the
food. Additionally, because the language in Sec. 101.13(b)(2)(ii)
parallels the definition of ``healthy'' in Sec. 101.65, we are also
proposing to update the language in Sec. 101.13(b)(2)(ii) to provide
that an implied nutrient content claim suggests that a food, because of
its nutrient content, may be useful in maintaining healthy dietary
practices, where there is also implied or explicit information about
the nutrition content of the food (e.g., healthy).
[[Page 59183]]
Under the proposed regulation, ``healthy,'' when used outside of a
nutritional context, would not be an implied nutrient content claim.
However, even outside of the nutritional context, we have the authority
under the misbranding provisions at section 403(a) of the FD&C Act, to
ensure that ``healthy'' is not used in a misleading manner. The
proposed regulation also does not address use of the term ``healthy''
when used as part of an implied health claim (e.g., ``heart healthy'')
instead of a nutrient content claim. See 21 CFR 101.14 for information
on the use of express and implied health claims.
2. Food Group Equivalents
As explained in section VI.A (``Overview of Approach''), a food
group equivalent is the amount of a food from a particular food group
that must be contained in a food product for it to bear the ``healthy''
claim. Proposed Sec. 101.65(d)(2) would define a ``food group
equivalent'' as equal to the following:
A food group equivalent of a vegetable would be equal to
one \1/2\ c-eq vegetables.
A food group equivalent of a fruit would be equal to one
\1/2\ c-eq fruit.
A food group equivalent of grain would be \3/4\ oz-eq
whole grain.
A food group equivalent of dairy would be equal to \3/4\
c-eq dairy.
A food group equivalent of protein would:
[cir] For game meats, such as deer, rabbit, quail, and wild geese,
be 1 \1/2\ oz-eq; and
[cir] For seafood; eggs; beans, peas, and soy products; and nuts
and seeds, be 1 oz-eq.
We have divided the protein foods group into these subgroups, which
are distinct from the Dietary Guidelines, 2020-2025 subgroups, as
explained further in section V.B.3.b (``Individual foods'').
We are not proposing a food group equivalent for oils, because, as
explained in section V.B.3.b (``Individual foods''), we are only
proposing that certain oil-based foods meet the criteria for healthy,
and oil used in other foods does not contribute to eligibility for
bearing the ``healthy'' claim.
These food group equivalents are indicated in table 1.
Table 1--Food Group Equivalents
------------------------------------------------------------------------
Food group and/or subgroup Food group equivalent
------------------------------------------------------------------------
Vegetables................... \1/2\ cup equivalent vegetable.
Fruits....................... \1/2\ cup equivalent fruit.
Grains....................... \3/4\ ounce (oz) equivalent whole grain.
Dairy........................ \3/4\ cup equivalent dairy.
Protein Foods................ Game meats.
1\1/2\ oz equivalent.
Seafood.
1 oz equivalent.
Egg.
1 oz equivalent.
Beans, peas, and soy products.
1 oz equivalent.
Nuts and seeds.
1 oz equivalent.
------------------------------------------------------------------------
As noted in section VI.A (``Overview of Approach''), the c-eq and
oz-eq amounts are based on the amounts discussed in the Dietary
Guidelines, 2020-2025. For vegetables and fruits, a 1 c-eq is: 1 cup
raw or cooked vegetable or fruit, 1 cup 100 percent vegetable or fruit
juice, 2 cups leafy salad greens, or \1/2\ cup dried fruit or
vegetable. For grains, a 1 oz-eq is: \1/2\ cup cooked whole grain rice,
whole grain pasta, or cereal; 1 oz dry whole grain pasta or rice; 1
medium (1 oz) slice whole grain bread, tortilla, or flatbread; 1 oz of
ready-to-eat whole grain cereal. For dairy, a 1 c-eq is: 1 cup fat-free
or low-fat milk, yogurt or lactose-free versions, or fortified soy
beverage or yogurt alternatives; 1\1/2\ oz natural cheese or 1 oz
processed cheese. For protein foods, a 1 oz-eq is: 1 oz game meat or
seafood; 1 egg; \1/4\ cup cooked beans or tofu; 1 tbsp nut or seed
butter; \1/2\ oz nuts or seeds (Refs. 1 and 22).
This means, for example, that a \1/2\ cup portion of fresh or
frozen green beans and a 1 cup portion of raw spinach would both
constitute \1/2\ c-eq vegetables. A \1/2\ cup portion of fresh or
frozen fruit, \1/2\ cup portion of 100 percent orange juice, and a \1/
4\ cup portion of raisins (a dried fruit) would all be equal to a \1/2\
c-eq of fruit. A slice of whole wheat bread and a \1/2\ cup portion of
cooked brown rice would both be equal to a 1 oz-eq whole grains. A 6-
ounce portion of yogurt would be equivalent to \3/4\ c-eq dairy. An
ounce portion of walnuts and 2 tablespoons of peanut butter would be
equal to 2 oz-eq of protein foods. A \1/2\ cup portion of black beans
would be equal to 2 oz-eq of protein foods (Refs. 1 and 22). Examples
of foods and their amounts that meet the food group equivalent
requirements are included in a table in the proposed codified language
for Sec. 101.65(d)(2).
3. Covered Products
Under proposed Sec. 101.65(3), you may use the term ``healthy'' or
related terms (e.g., ``health,'' ``healthful,'' ``healthfully,''
``healthfulness,'' ``healthier,'' ``healthiest,'' ``healthily,'' and
``healthiness'') as an implied nutrient content claim if the food meets
the requirements laid out in proposed Sec. 101.65(d)(3)(i)-(vi). These
terms are unchanged from the existing regulation at Sec. 101.65(d);
see the 1994 ``healthy'' final rule for a more detailed discussion of
how these terms were selected (59 FR 24232 at 24235). However, we seek
comments on whether there are any other terms synonymous with
``healthy'' that we should consider as we finalize this rulemaking.
Foods that may bear the nutrient content claim ``healthy'' under
the proposed updated criteria are broken out into several categories:
(1) raw, whole fruits and vegetables; (2) individual food products; (3)
combination foods, which encompasses mixed products, main dish
products, and meal products; and (4) plain water. The specific
requirements for these foods are described in more detail in the
following sections.
[[Page 59184]]
Table 2--Eligible Products for ``Healthy'' Nutrient Content Claim
------------------------------------------------------------------------
Eligible products for ``healthy'' nutrient content claim
-------------------------------------------------------------------------
Criteria for bearing
Product ``healthy'' claim
------------------------------------------------------------------------
Raw, whole fruits and vegetables....... No additional criteria; all
raw, whole fruits and
vegetables may bear the claim.
Individual food products............... At least 1 food group
equivalent per RACC from 1
food group, and Nutrients to
limit.
Mixed products......................... At least \1/2\ food group
equivalent each from at least
2 different food groups, and
Nutrients to limit.
Main dish as defined at 21 CFR At least 1 food group
101.13(m). equivalent each from at least
2 different food groups, and
Nutrients to limit.
Meal as defined at 21 CFR 101.13(l).... At least 1 food group
equivalent each from at least
3 different food groups, and
Nutrients to limit.
Water.................................. Plain water and plain,
carbonated water may bear the
claim.
------------------------------------------------------------------------
a. Raw, Whole Fruits and Vegetables
A key objective of the updated criteria is to ensure conformity
with current nutrition science and Federal dietary guidance by, among
other things, ensuring that the nutrient dense foods recommended by the
Dietary Guidelines, 2020-2025 are eligible to bear the ``healthy''
claim. Precluding such foods from bearing the ``healthy'' claim could
undermine an important element of the claim, as the purpose of the
healthy claim is to identify foods that, because of their nutrient
content, may help consumers maintain healthy dietary practices,
consistent with current nutrition science and Federal dietary guidance.
Healthy dietary patterns described by the Dietary Guidelines, 2020-2025
include vegetables from all vegetable subgroups (dark green, red and
orange, beans, peas, and lentils, starchy, and other) and fruits,
especially whole fruits. Vegetables contribute many nutrients to the
diet including dietary fiber, potassium, vitamin A, vitamin C, vitamin
K, copper, magnesium, vitamin E, vitamin B6, folate, iron, manganese,
thiamin, niacin, and choline, while fruits are important contributors
of dietary fiber, potassium, and vitamin C. The Dietary Guidelines have
consistently emphasized consumption of fruits and vegetables (Ref. 15),
and diets high in fruits and vegetables have been associated with
specific health benefits, including lower occurrence of coronary heart
disease and some cancers (Ref. 16 and 59 FR 24232 at 24244). Despite
their importance to a healthy dietary pattern, average intake of
vegetables and fruits is below recommended levels among nearly all age-
sex groups (Ref. 1).
While we are proposing food group equivalent and nutrient-to-limit
requirements for most foods, we are not proposing to subject raw, whole
fruits and vegetables to the criteria. For the purpose of this rule,
``raw, whole'' means whole fruits and vegetables that have not been
processed, such as whole apples, bananas, or carrots. Raw, whole fruits
and vegetables automatically qualify for use of the claim, regardless
if they meet the criteria required of other foods. As discussed in the
Dietary Guidelines 2020-2025, most of the U.S. population (around 80
percent) does not meet the dietary intake recommendation for fruits and
an even larger percentage (around 90%) do not meet the intake
recommendation for vegetables. Excluding some raw, whole fruits and
vegetables from qualifying for the proposed, updated ``healthy''
definition is not supported by scientific evidence or current dietary
guidance. Therefore, we tentatively conclude that raw, whole fruits and
vegetables do not need to contain a certain amount of fruit or
vegetable to contribute to a healthy dietary pattern--for example, a
strawberry should be able to bear the ``healthy'' claim even though one
strawberry does not constitute a \1/2\ c-eq of fruit. Moreover, raw,
whole fruits and vegetables are often sold without packaging or labels.
While these products typically do not carry label claims, they may
appear on other materials in the stores and elsewhere that may
constitute labeling. We therefore tentatively conclude that raw, whole
vegetables and fruits should be able to meet the ``healthy'' criteria
without meeting a food group equivalent threshold. We seek comment on
our tentative conclusions.
We also tentatively conclude that it would be inappropriate to
apply nutrient-to-limit criteria to raw, whole vegetables and fruits.
For example, sodium and added sugars are not a concern for raw, whole
fruits and vegetables because they contain no added ingredients.
Furthermore, including a limit for saturated fat would actually
disqualify certain vegetables, such as whole avocados, which are
vegetables containing beneficial nutrients and are sources of
unsaturated fat, from meeting the updated ``healthy'' criteria.
For these reasons, we are proposing a narrow exception to the
requirements for food group equivalents and nutrients to limit for raw,
whole fruits and vegetables. We propose allowing all raw, whole fruits
and vegetables to bear the implied nutrient content claim ``healthy,''
without any additional requirements for food group equivalents or
nutrients to limit.
We do not propose to include processed fruits and vegetables, such
as canned, frozen, dried, or pureed fruits and vegetables, within this
exemption, though many may still meet the criteria to bear ``healthy.''
For purposes of this claim, fruits and vegetables that have been cut
and packaged for sale, such as cantaloupe pieces cut and packaged for
sale in a supermarket are considered processed. We note that fruits and
vegetables that have been solely cut and packaged for sale would
generally qualify for use of the claim under the criteria for
individual foods, as raw fruits and vegetables do not exceed the
nutrient criteria and would meet the food group equivalent requirement.
For example, plain frozen fruit or vegetables would not exceed the
nutrient-to-limit criteria and would meet the food group equivalent
requirement. It is possible, though, that there are a few forms of
fruit and vegetable products that may have RACCs that are smaller than
the size of the required food group equivalent requirement. For
example, frozen avocado pieces, specifically, may have a RACC that does
not meet the FGE amount criteria of \1/2\ c fruit. We request comment
on whether there are any other fruit or vegetable products for which
the RACC size may have an impact in terms of qualifying for the claim
and we request comment on ways we could address how those products,
including frozen avocados, could qualify for the claim. Many processed
fruits and vegetables are packaged and sold in a form that makes it
appropriate to apply
[[Page 59185]]
the food group equivalent requirement to these kinds of food to ensure
the product contains a meaningful amount of the fruit and/or vegetable.
For example, it is appropriate to require that canned fruit products
contain a certain amount of fruit per serving in order to bear the
``healthy'' claim because they contain additional ingredients (e.g.,
sugar solution) which may impact whether the product has enough fruit
per serving to meet the food group equivalent requirement. Furthermore,
processed vegetables and fruits may contain other ingredients, such as
added sugars or sodium, that can affect their nutrient content; thus,
it is necessary to include nutrient-to-limit criteria for such foods.
For any type of processed fruits and vegetables where the fruits and
vegetables remain primarily unchanged, such as plain frozen fruits and
vegetables, those products would generally qualify for use of the claim
under the criteria for individual foods, as they do not exceed the
nutrient criteria and would meet the food group equivalent requirement.
As described in section V.B.3.b (``Individual foods''), we are
proposing that individual fruit and vegetable products (including
processed fruits and vegetables, but which excludes raw, whole fruits
or vegetables) may bear the nutrient content claim ``healthy'' only
when they meet certain additional food group equivalent and nutrient-
to-limit requirements.
b. Individual Foods
Individual foods are foods that are comprised entirely or almost
entirely of one food group (excluding raw, whole fruits and vegetables,
as explained above). Foods that contain a meaningful amount (at least
half a food group equivalent) of more than one food group would be
considered a combination food and are discussed in section VI.B.3.c
(``Combination foods''). In many cases, an individual food will be
comprised of only one food group; for example, individual foods include
oatmeal (which is comprised of only whole grain), dried fruit (fruit),
or low-fat plain yogurt (dairy). In some cases, individual foods
include ingredients from multiple food groups, but one food group would
still predominate, and the product may only contain a minimal amount of
another food group; for example, cinnamon raisin oatmeal (primarily
whole grain) and yogurt with granola topping (primarily dairy) would
both be individual foods. To bear the nutrient content claim
``healthy,'' individual foods would have to meet the criteria outlined
in Sec. 101.65(d)(3)(iii), which includes requirements for food group
equivalents and for nutrients to limit.
For the purposes of this rule, individual foods have been separated
into the six food groups described in the Dietary Guidelines, 2020-
2025: vegetables, fruits, grains, dairy, proteins (including all
subgroups), as well as oils. As in the Dietary Guidelines, 2020-2025,
individual foods fit into food groups based on how they are consumed,
even if this is different from their botanical classification. We are
proposing that individual products would need to contain a specified
minimum food group equivalent per RACC (e.g., \1/2\ cup of fruit, \3/4\
cup of dairy) to be labeled ``healthy.'' Individual products would also
need to adhere to criteria for nutrients to limit per RACC for
saturated fat, sodium, and added sugars. The food group equivalents and
the nutrients-to-limit benchmarks are adjusted for each food group. The
specific food group equivalent criteria, along with the criteria for
nutrients to limit, are discussed further in the following sections.
(1) Vegetable Products
As discussed previously, healthy dietary patterns include
vegetables from all vegetable subgroups: dark green, red and orange,
beans, peas, and lentils, starchy, and other. The nutrient content of
beans, peas, and lentils is similar to foods in both the protein foods
group and in the vegetable group and may be counted under either food
group. Vegetables contribute many nutrients to the diet including
dietary fiber, potassium, and iron, among others, and nutrient
contributions can vary across the subgroups (Ref. 21). The Dietary
Guidelines, 2020-2025 notes that each of the food groups and their
subgroups provides an array of nutrients and that eating an appropriate
mix of foods from the food groups and subgroups is important to promote
health at each life stage (Ref. 1). Therefore, consumption of a variety
of vegetables from all vegetable subgroups in nutrient-dense forms is
encouraged. The vegetables food group can include fresh, frozen,
canned, and dried forms of vegetables, as well as 100% vegetable juice.
FDA considers concentrated vegetable purees and vegetable pastes to be
vegetables for the purpose of calculating food group equivalents since
these products are essentially whole vegetables that have been
processed to change the physical form of the vegetable to remove
moisture. We tentatively do not consider vegetable powders to be
vegetables for the purpose of calculating food group equivalents. These
products could be produced or used in a way that modifies the whole
vegetable to an extent that removes some essential characteristics that
are beneficial when consuming the whole vegetable, which could impact
nutrient content. However, we recognize that food manufacturers
continue to innovate in this space. We welcome comment on whether we
should consider certain vegetable powders to be vegetables for the
purpose of calculating food group equivalents. In particular, we are
interested in any comments or data regarding whether vegetable powders
have similar or different nutrient content, or similar or different
roles in a healthy dietary pattern, compared to whole vegetables.
The recommended amount of vegetables in the Healthy U.S.-Style
Dietary Pattern at the 2,000-calorie level is 2\1/2\ c-eq of vegetables
per day. As described in section VI.B.3.b (``Individual foods''), for
most food groups and subgroups, we determined the ``food group
equivalent'' by dividing the daily recommended amount by four (for four
eating occasions per day). For vegetables, we revised the amount
derived from the baseline calculation slightly (from \3/4\ c-eq down to
\1/2\ c-eq) for two reasons. First, vegetables are significantly
underconsumed according to the Dietary Guidelines, 2020-2025. Second,
we found that a \1/2\ c-eq aligned better with the RACCs for most
vegetable products as set out in FDA's NFL final rule. Thus, we are
proposing that to bear the nutrient content claim ``healthy,'' a
vegetable product must contain at least \1/2\ c-eq vegetables per RACC.
We are proposing that the added sugars content for vegetable
products must be no greater than 0 percent DV per RACC. This is lower
than some other food groups because vegetable products generally do not
contain added sugars. We are proposing that vegetable products be
subject to the baseline values for sodium and saturated fat; i.e., the
sodium content must be no greater than 10 percent DV per RACC and the
saturated fat content must be no greater than 5 percent DV per RACC, as
many vegetable products in the food supply contain some sodium and
added fats for taste, processing, and preservation. We are seeking
comment on this proposal.
[[Page 59186]]
Table 3--Vegetable Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
Food group equivalent Added sugar Saturated fat
minimum limit Sodium limit limit
----------------------------------------------------------------------------------------------------------------
Vegetable product..................... \1/2\ cup-equivalent.... 0% DV 10% DV 5% DV
----------------------------------------------------------------------------------------------------------------
(2) Fruit Products
Healthy dietary patterns include fruits, especially whole fruits.
Fruits contribute many nutrients to the diet, including dietary fiber,
potassium, and vitamin C (Ref. 21). Fruits can be consumed in fresh,
frozen, canned, and dried forms. FDA considers concentrated fruit
purees and fruit pastes to be fruit for the purpose of calculating food
group equivalents since these products are essentially whole fruits
that have been processed to change the physical form of the fruit to
remove moisture. The fruits food group also includes 100 percent fruit
juice. We tentatively do not consider fruit powders to be fruits for
the purpose of calculating food group equivalents. These products could
be produced or used in a way that modifies the whole fruit to an extent
that removes some essential characteristics that are beneficial when
consuming the whole fruit, which could impact nutrient content.
However, we recognize that food manufacturers continue to innovate in
this space. We welcome comment on whether we should consider certain
fruit powders to be fruits for the purpose of calculating food group
equivalents. In particular, we are interested in any comments or data
regarding whether fruit powders have similar or different nutrient
content, or similar or different roles in a healthy dietary pattern,
compared to whole fruits.
The recommended amount of fruits in the Healthy U.S.-Style Dietary
Pattern at the 2,000-calorie level is 2 c-eq per day. Applying the
baseline calculation discussed in section VI.B.3.b (``Individual
foods''), we propose that an individual fruit product must contain at
least \1/2\ c-eq of fruit per RACC to bear the ``healthy'' claim. We
are seeking comment on this proposal.
As with vegetable products, we are proposing to lower the baseline
added sugars limit to 0 percent DV per RACC for fruit products. While
small amounts of added sugars can be part of a healthy dietary
pattern--the Dietary Guidelines, 2020-2025 recommendations allow for a
certain allotment of added sugars per day--we do not want the
``healthy'' claim to encourage addition of added sugars in otherwise
nutrient-dense fruit products, which are generally already naturally
sweet. Moreover, while we recognize that some fruit juices and canned
fruits contain added sugars, the Dietary Guidelines, 2020-2025
specifically recommends that juices should be 100 percent juice,
without added sugars, and that individuals should choose canned fruits
that are canned with 100 percent juice or options lowest in added
sugars. Thus, to qualify for the ``healthy'' claim, we propose to allow
no added sugars in fruit products (which includes products with 100
percent fruit juice). For the fruit category, we find that there are no
special circumstances that require deviation from the baseline levels
for sodium and saturated fat, so we are proposing the baseline value
for sodium of 10 percent DV per RACC and 5 percent DV saturated fat per
RACC for fruit products.
Table 4--Fruit Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
Food group equivalent Added sugar Saturated fat
minimum limit Sodium limit limit
----------------------------------------------------------------------------------------------------------------
Fruit product......................... \1/2\ cup-equivalent.... 0% DV 10% DV 5% DV
----------------------------------------------------------------------------------------------------------------
(3) Grain Products
Healthy dietary patterns include whole grains and limit the intake
of refined grains. Whole grains contain the entire kernel, including
the endosperm, bran, and germ. Refined grains differ from whole grains
in that the grains have been processed to remove the bran and germ,
which removes important nutrients. Whole grains provide nutrients such
as dietary fiber, iron, zinc, manganese, folate, magnesium, copper,
thiamin, niacin, vitamin B6, phosphorus, selenium, riboflavin, and
vitamin A (Ref. 21). Whole grains can be consumed as single foods
(e.g., brown rice, oats), or as products that include grains as an
ingredient (e.g., breads, cereals, crackers, and pasta).
The recommended amount of grains in the Healthy U.S.-Style Dietary
Pattern at the 2,000-calorie level is 6 oz-eq per day. At least half of
this amount should be whole grains (i.e., at least 3 oz-eq). Whole
grains, when prepared with little or no added sugars, sodium, and
saturated fat, are typically more nutrient-dense foods and the Dietary
Guidelines, 2020-2025 indicates that whole grains are underconsumed
while refined grains are overconsumed. Thus, we propose that grain
products must contain whole grains to bear the ``healthy'' claim.
Applying the baseline calculation for food group equivalent as
explained in section VI.A (``Overview of Approach''), we are proposing
that a whole grain equivalent is \3/4\ oz-eq. This means that to bear
the ``healthy'' claim, an individual grain product must contain at
least \3/4\ oz-eq whole grains per RACC. We seek comment on this
approach.
For the grains category, we find that there are no special
circumstances that require deviation from the baseline levels, so we
are proposing the baseline value for all of the nutrients to limit: the
added sugars content must be no greater than 5 percent DV per RACC, the
sodium content must be no greater than 10 percent DV per RACC, and the
saturated fat content must be no greater than 5 percent DV per RACC.
[[Page 59187]]
Table 5--Grain Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
Food group equivalent Added sugar Saturated fat
minimum limit Sodium limit limit
----------------------------------------------------------------------------------------------------------------
Grain product......................... \3/4\ ounce-equivalent 5% DV 10% DV 5% DV
wholegrain.
----------------------------------------------------------------------------------------------------------------
(4) Dairy Products
Dairy in healthy dietary patterns includes fat-free (skim) and low-
fat (1 percent) milk, yogurt, cheese, and fortified soy beverages or
soy yogurt alternatives. Nutrients provided by foods in the dairy food
group include calcium, phosphorus, vitamin A, vitamin D, riboflavin,
vitamin B12, protein, potassium, zinc, choline, magnesium, and selenium
(Ref. 21). The Dietary Guidelines, 2020-2025 states that about 90
percent of the U.S. population does not meet dairy recommendations and
most individuals would benefit by increasing intake of dairy in fat-
free or low-fat forms, whether from milk, yogurt, and cheese, lactose-
free versions, or from fortified soy beverages or soy yogurt
alternatives. Fat-free and low-fat dairy products provide the same
nutrients but less saturated fat (and thus, fewer calories) than higher
fat options, such as 2 percent and whole milk and regular cheese.
The Dietary Guidelines, 2020-2025 includes fortified soy beverages
and soy yogurt alternatives in the dairy group because they have
similar nutrient compositions and use in meals (Refs. 1, 22). Other
products and beverages made from plants (e.g., almond, rice, coconut,
oat, and hemp products) are not included in the dairy group because
their overall nutritional content is not similar to dairy milk, yogurt,
and fortified soy beverages and soy yogurt alternatives (e.g., lower
levels of calcium, vitamin D, and other nutrients). However, it is
possible that these types of products may eventually be formulated or
fortified to have nutritional profiles that are more similar to the
nutritional profile of the dairy food group. Although FDA does not
generally support fortification as a method to qualify for a
``healthy'' claim, fortification of soy beverage and yogurt
alternatives and other plant-based beverage and yogurt alternatives are
a special circumstance. As discussed earlier in this rule, around 90
percent of the U.S. population does not meet the dairy recommendations
even though dairy is a core element of a healthy dietary pattern. The
Dietary Guidelines, 2020-2025 highlights the importance of increasing
overall intake of dairy foods while acknowledging that some individuals
are in need of alternative dairy options. For example, lactose-free and
low-lactose options are suggested for those with issues in digesting
traditional dairy products. For individuals with restrictions on
consumption of traditional dairy foods (e.g., medical restrictions or
religious preferences), fortified soy beverages and soy yogurt
alternatives are included in the dairy group. Including fortified
plant-based dairy alternatives among the food options in the dairy
group can assist consumers in increasing their dairy intake and meeting
the dairy intake recommendations. Therefore, to support the
availability of non-dairy choices for individuals who are lactose
intolerant or allergic to dairy or choose not to consume dairy, plant-
based milk alternatives and plant-based yogurt alternatives whose
overall nutritional content is similar to dairy (e.g., provide similar
amounts of protein, calcium, potassium, magnesium, vitamin D, and
vitamin A) (Ref. 21) and are used as alternatives to milk and yogurt
would be evaluated against the dairy criteria for the purposes of the
``healthy'' nutrient content claim.
The recommended amount of dairy in the Healthy U.S.-Style Dietary
Pattern at the 2,000-calorie level is 3 c-eq per day. Based on our
baseline calculations, we are proposing that a food group equivalent of
dairy equal \3/4\ c-eq. This means that an individual dairy food must
contain at least \3/4\ c-eq of dairy per RACC to bear the ``healthy''
nutrient content claim.
We are proposing to increase the saturated fat limit for dairy
products from the baseline level. Under the baseline saturated fat
limit of 5 percent DV, low-fat dairy (e.g., 1 percent milk) would not
meet the criteria for bearing the ``healthy'' claim (Ref. 20). Forms of
dairy that are more nutrient dense (i.e., fat-free and low-fat dairy
products) provide important nutrients with less saturated fat than 2
percent or whole-fat dairy. As stated above, the Dietary Guidelines,
2020-2025 therefore recommends increasing intake of dairy products in
fat-free and low-fat forms, to replace intake of 2 percent or whole
dairy. We are proposing to revise the saturated fat limit for dairy to
<=10 percent DV of saturated fat per RACC to allow low-fat dairy to
bear the ``healthy'' claim provided the other proposed criteria are
met.
We are also proposing that dairy products (e.g., sweetened yogurt
and cheese) must meet the baseline limit for added sugars of 5 percent
DV per RACC and for sodium of 10 percent DV per RACC. We find that
there are no special circumstances that require deviation from the
baseline levels for added sugars and sodium. Additionally, the sodium
level of 10 percent is appropriate because many dairy products,
especially cheeses, can be expected to contain some sodium due to
processing and preservation methods. We seek comment on this approach.
Table 6--Dairy Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
Food group equivalent Added sugar Saturated fat
minimum limit Sodium limit limit
----------------------------------------------------------------------------------------------------------------
Dairy product......................... \3/4\ cup-equivalent.... 5% DV 10% DV 10% DV
----------------------------------------------------------------------------------------------------------------
(5) Protein Food Products
Healthy dietary patterns include a variety of protein foods in
nutrient-dense forms, including protein foods from both plant and
animal sources. Plant sources of proteins can include nuts, seeds,
beans, peas, and lentils, and soy products. The nutrient content of
beans, peas, and lentils is similar to foods in both the protein foods
group and in the vegetable group and may be counted under either
category. Animal sources can include seafood, meat, poultry, and eggs.
Along with protein, foods in this group contribute important nutrients
such as niacin, vitamin B12, vitamin B6, riboflavin, selenium,
[[Page 59188]]
choline, phosphorus, zinc, copper, vitamin D, and vitamin E and iron
(Ref. 21). Additionally, seafood can provide polyunsaturated omega-3
fatty acids (eicosapentaenoic acid and docosahexaenoic acid). While
Americans' overall intakes of protein foods are close to the
recommended amounts, many Americans do not meet the intake
recommendations for specific protein subgroups. Therefore, the Dietary
Guidelines, 2020-2025 recommends shifts within the protein group to add
variety to the intake of protein foods (Ref.1).
Since specific considerations for different foods within the
protein foods group may vary, we are proposing to divide protein foods
into the following subgroups: (1) game meats; (2) seafood; (3) eggs;
(4) beans, peas, lentils, and soy products; and (5) nuts and seeds.
These subgroups are slightly different from the subgroups in the
Dietary Guidelines, 2020-2025 because they are based on what we
determined as the specific needs for variation in food group
equivalents and the nutrients to limit, as discussed below. In
addition, our subgroups do not include the animal sources of protein
whose labeling is regulated by USDA's Food Safety and Inspection
Service (e.g., meat and poultry products, egg products, and catfish).
The recommendation for protein foods in the Healthy U.S.-Style
Dietary Pattern at the 2,000-calorie level is 5\1/2\ ounce-equivalents
per day. As with all of the food groups, we calculated the food group
equivalent using the method described in section VI.B.3.b (``Individual
foods''). One fourth of 5\1/2\ oz equivalents is 1\3/8\ oz equivalents
and based on standard rounding rules, we propose that the food group
equivalent criteria for game meat is at least 1\1/2\ oz equivalent. We
propose rounding down to 1 oz-eq for all other protein subgroups. For
beans, peas, lentils, soy products, and seafood, we propose rounding
down to increase the number of products containing these subgroups that
would be eligible to bear the claim, and therefore encourage
consumption of them. This is consistent with the Dietary Guidelines,
2020-2025 strategy to increase variety of choices made by replacing
some meats, poultry, and egg intake with seafood, beans, peas, and
lentils, nuts, seeds, and soy products. Game meat, which is part of the
traditional diets of certain populations, falls within the meat,
poultry, and egg protein subgroup in the Dietary Guidelines. However,
we acknowledge that intake levels of game meat may not be at similar
levels as other meat, poultry and egg products. We also propose
rounding down to at least 1 oz-eq for eggs as this is equal to one egg,
a common serving size. We welcome comments on the values set for the
food group equivalents for the protein subgroups.
For all of the protein food subgroups, we propose that the food
contain no more than 0 percent DV of added sugars per RACC because most
protein food products generally do not contain added sugars. We are
also proposing that all protein products must meet the baseline limit
for sodium of 10 percent DV per RACC as many protein products in the
food supply contain some sodium for taste, processing, and/or
preservation.
Because protein foods are a diverse group of foods containing
varying amounts of saturated fat, we are proposing different saturated
fat limits for some subgroups. For game meats, seafood, and eggs, we
are proposing to increase the limit for saturated fat to 10 percent DV
because using the baseline saturated fat limit would prevent these
foods from being able to bear the ``healthy'' claim even though they
contain important nutrients that may help consumers maintain healthy
dietary practices. The Dietary Guidelines, 2020-2025 recommends
shifting to nutrient-dense options when selecting protein foods,
specifically lean and low-fat options. We propose a <=10 percent DV
saturated fat limit for game meat, which is similar to the <2 g per
RACC saturated fat limit for the ``extra lean'' nutrient content claim
for seafood or game meat products (Sec. 101.62(e)(4)) as is used in
the current criteria for ``healthy.'' Seafood provides important
nutrients, such as beneficial fatty acids (e.g., eicosapentaenoic acid
(EPA) and docosahexaenoic acid (DHA)). The Dietary Guidelines, 2020-
2025 encourages consumption of seafood but note that almost 90 percent
of Americans do not meet that recommendation and that protein foods are
generally consumed in forms with higher amounts of saturated fat or
sodium. Thus, the Dietary Guidelines, 2020-2025 recommends replacing
processed or high-fat meats with seafood to help lower intake of
saturated fat and sodium (Ref. 1). We propose a <=10 percent DV
saturated fat limit for seafood consistent with Sec. 101.62(e)(4) and
because seafood contains beneficial nutrients that make it part of a
healthy dietary pattern.
We are also proposing an adjustment for eggs. As mentioned
previously, the Dietary Guidelines, 2020-2025 recommends increasing
variety in protein food choices in order to meet the recommendations
for specific protein subgroups. Eggs are considered a nutrient dense
protein food option, particularly compared with some protein foods that
typically have high levels of saturated fat and sodium (e.g.,
sausages). While about three-quarters of Americans meet the
recommendation for the meat, poultry, and eggs subgroup, eggs provide
choline and vitamin D, two nutrients with notably low intakes (Ref. 1).
As noted above, using the baseline limit of 5 percent DV of saturated
fat per RACC would prevent eggs from being able to bear the ``healthy''
claim, so we are also proposing to raise the saturated fat limit for
eggs to <=10 percent DV per RACC. Beans, peas, and lentils and soy
products are inherently low in saturated fat; therefore, we are
proposing the baseline value for saturated fat of <=5 percent DV per
RACC for these foods.
We are also proposing that the saturated fat content of nuts and
seeds does not contribute toward the overall saturated fat limit for
nut and seed products, which would be the baseline value of <=5 percent
DV per RACC. Unsalted nuts and seeds are considered nutrient dense
protein foods due to their nutrient content (e.g., they provide
important nutrients such as unsaturated fatty acids and vitamin E).
While nuts and seeds contain saturated fat, they have a fat profile
makeup of predominantly monounsaturated and polyunsaturated fats.
Numerous studies have demonstrated that replacing other sources of
saturated fat in the diet with nuts has beneficial effects on
cardiovascular disease risk, including nuts with higher saturated fat
content (Refs. 22 and 33). Based on the scientific evidence, FDA has
qualified health claims characterizing the relationship between the
consumption of nuts and a reduced risk of coronary heart disease,
including a qualified health claim for macadamia nuts which are
relatively higher in saturated fat than other nuts. More than half of
Americans do not meet the recommendation for nuts, seeds, and soy
products, and the Dietary Guidelines, 2020-2025 recommends consuming
nuts without differentiating among types and the saturated fat content
of nuts is variable. The Dietary Guidelines, 2020-2025 also recommends
reducing saturated fat by substituting certain ingredients with sources
of unsaturated fats, including using nuts and seeds in a dish instead
of cheese (Ref. 1). If nuts' and seeds' saturated fat content
contributed to the overall baseline saturated fat value of <=5 percent
DV per RACC, then most nuts and seeds would be prevented from meeting
the ``healthy'' definition (Ref. 20). Even increasing the allowable
level
[[Page 59189]]
of saturated fat to levels twice as much (10 percent DV) would prevent
some nuts and seeds, such as macadamia nuts, from being eligible for
the ``healthy'' claim, despite the science supporting their beneficial
impact on cardiovascular health. As mentioned above, the saturated fat
content of nut and seed varieties vary. However, excluding specific
types of nuts and seeds from being eligible for the claim would be
inconsistent with the scientific evidence demonstrating a beneficial
effect of nut consumption on health outcomes, which is the basis for
current dietary recommendations that nuts and seeds are part of a
healthy dietary pattern. We therefore propose that, for nut and seed
products, the saturated fat from the nuts and seeds do not contribute
toward the overall saturated fat limit. For example, a peanut butter
product may contain peanuts and vegetable oil. In this example, both
the peanuts and vegetable oil contain saturated fats. However, the
saturated fat from the peanuts would not contribute to the saturated
fat limit of <=5 percent DV per RACC; only the saturated fat from the
vegetable oil would contribute to the limit. Therefore, if the
saturated fat from the vegetable oil is <=5 percent DV of the RACC,
then the peanut butter would meet the saturated fat limit.
Additionally, if a product only contained nuts, such as a jar of raw,
unsalted peanuts, the product would not be subject to a saturated fat
limit in order to bear the ``healthy'' claim.
We seek comment on whether nuts with relatively higher amounts of
saturated fat should be eligible for the ``healthy'' claim.
Table 7--Protein Product Requirements Per RACC
----------------------------------------------------------------------------------------------------------------
Food group equivalent Added sugar Saturated fat
minimum limit Sodium limit limit
----------------------------------------------------------------------------------------------------------------
Game meat...................... 1\1/2\ oz equivalent....... 0% DV 10% DV 10% DV.
Seafood........................ 1 oz equivalent............ 0% DV 10% DV 10% DV.
Egg............................ 1 oz equivalent............ 0% DV 10% DV 10% DV.
Beans, peas, and soy products.. 1 oz equivalent............ 0% DV 10% DV 5% DV.
Nuts and seeds................. 1 oz equivalent............ 0% DV 10% DV 5% DV (excluding
saturated fat
derived from nuts
and seeds).
----------------------------------------------------------------------------------------------------------------
(6) Oils
While oils are not technically a food group in the Dietary
Guidelines, 2020-2025, the Dietary Guidelines, 2020-2025 emphasizes
oils as part of a healthy dietary pattern because they are a common
characteristic of dietary patterns associated with positive health
outcomes and provide essential fatty acids (Ref. 1). As part of its
focus on shifts--that is, choosing nutrient-dense foods and beverages
in place of less healthy choices, rather than increasing intake
overall--the Dietary Guidelines, 2020-2025 recommends cooking with
vegetable oil in place of fats high in saturated fat (such as butter,
shortening, lard, and coconut oil) as a strategy to shift intake.
We propose including 100 percent oils, oil-based spreads, and oil-
based dressings in the definition of ``healthy'' where they meet
certain specified requirements. While the Healthy U.S.-Style Dietary
Pattern at the 2,000-calorie level recommends 27 g (about 5 teaspoons)
per day of oils, we are not proposing that oil products contain a
certain quantity of oil in order to be labeled healthy. This is because
the Dietary Guidelines, 2020-2025 does not recommend high consumption
of oil, but instead that oils be used instead of fats high in saturated
fats while staying within daily calorie limits. The proposed
requirements for oils, oil-based spreads, and oil-based dressings are
discussed in further detail in this section.
Under proposed Sec. 101.65(d)(2)(iii)(F)(1), for 100 percent oils
to bear the ``healthy'' claim, they would have to contain only oil,
which means they would contain no sodium or added sugars. For the 100
percent oil subcategory, we are proposing a limit of saturated fat of
<=20 percent of total fat. The Dietary Guidelines, 2020-2025 emphasizes
oils, such as canola, corn, olive, and sunflower oils, as part of a
healthy dietary pattern because of their fatty acid profile. However,
the Dietary Guidelines, 2020-2025 specifically does not include the fat
from some tropical plants, such as coconut oil, palm kernel oil, and
palm oil, in the category of oils because they contain a higher
percentage of saturated fats than other oils. We propose the 20 percent
limit on saturated fat to ensure that only oils with a fat profile of
predominantly monounsaturated and polyunsaturated fats, as recommended
by the Dietary Guidelines, 2020-2025, meet the criteria for
``healthy.'' The proposed 20 percent limit is consistent with the
percentage used by the National Academies to describe dietary fats low
in saturated fatty acids (Ref. 7). This 20 percent saturated fat limit
is also consistent with the saturated fat requirement for determining
the type of foods that are eligible to bear the claim on the
``Substitution of Saturated Fat in the Diet with Unsaturated Fatty
Acids and Reduced Risk of Heart Disease'' (Docket No. FDA-2007-Q-0291).
Thus, we propose a 20 percent limit on saturated fat in oils to bear
the nutrient content claim ``healthy.''
We also propose allowing oil-based spreads, such as tub margarine,
to bear the claim ``healthy'' when they meet certain requirements. Use
of spreads made with vegetable oils can help shift intake away from
other fats high in saturated fat. The Dietary Guidelines, 2020-2025
recommends cooking and purchasing products made with oils higher in
polyunsaturated and monounsaturated fats rather than using butter,
shortening, or coconut or palm oils (Ref. 1). Thus, we propose allowing
oil-based spreads to qualify only when their fat content comes solely
from oils and where the product's overall saturated fat content is no
more than 20 percent of total fat. For such spreads, we are proposing a
limit for added sugars of 0 percent DV per RACC, as these products are
not expected to contain added sugars. We are also proposing to lower
the sodium limit to 5 percent DV per RACC for spreads, due to their
small RACCs. This approach is reasonable given that many of these
products already contain less than 5 percent DV of sodium per RACC
(Ref. 20). We seek comment on the proposed criteria for oil-based
spreads, particularly on whether the proposed saturated fat criteria
would adequately ensure that spreads that are part of a healthy dietary
pattern (because they are lower in saturated fat and higher in
unsaturated fatty acids, consistent with current nutrition science and
Federal dietary
[[Page 59190]]
guidance) are eligible to bear the ``healthy'' nutrient content claim.
We also propose allowing oil-based dressings to bear the claim
``healthy'' when they meet certain requirements. Similar to oil-based
spreads, use of dressings made with vegetable oils can help shift
intake away from use of dressings made with fats that are high in
saturated fat. For oil-based dressings to bear the claim ``healthy,''
we are proposing they must contain at least 30 percent oil, which is
consistent with the oil content in the standard of identity for salad
dressing (21 CFR 169.150). Dressings must be made from oils that meet
the requirements in Sec. 101.65(d)(2)(ii)(F)(1) (i.e., saturated fat
level of the oil must be <=20 percent of total fat).
We are proposing that oil-based dressings be permitted to contain
up to 2 percent DV of added sugars per RACC. Many dressings contain a
small amount of added sugars. We are proposing to allow a small amount
of added sugars because dressings are typically consumed with
vegetables, another highly recommended and underconsumed food group. We
are also proposing a sodium limit of <=5 percent DV per RACC for
dressings, due to their small RACCs. As with spreads, this approach is
reasonable given that many of these products already contain less than
5 percent DV of sodium per RACC (Ref. 20). Finally, we propose that the
dressings must meet a saturated fat limit of <=20 percent of total fat.
We seek comment on the proposed criteria for oil-based dressings; in
particular, we seek comment on whether the proposed 30 percent oil
level is an appropriate requirement for oil-based dressings, and on
whether the proposed saturated fat criteria adequately ensure that
dressings that are part of a healthy dietary pattern because they are
lower in saturated fat and higher in unsaturated fatty acids,
consistent with current nutrition science and Federal dietary guidance,
are eligible to bear the ``healthy'' claim.
Table 8--Oil Product Requirements per RACC
----------------------------------------------------------------------------------------------------------------
Food group
equivalent Added sugar Sodium limit Saturated fat limit
minimum limit
----------------------------------------------------------------------------------------------------------------
100% Oil........................... N/A 0% DV 0% DV 20% of total fat.
Oil-based Spreads.................. N/A 0% DV 5% DV 20% of total fat.
Oil-based Dressing (must contain at N/A 2% DV 5% DV 20% of total fat.
least 30% oil and saturated fat
level of the oil must be <=20
percent of total fat).
----------------------------------------------------------------------------------------------------------------
c. Combination Foods
(1) Overview
As explained previously, individual foods are foods that are
primarily comprised of one food group. In some cases, individual foods
can contain ingredients from multiple food groups, but not in high
enough quantities to equal a food group equivalent in more than one
food group. These types of foods are subject to the proposed
requirements in section VI.B.3.b (``Individual foods''). However, many
foods on the market contain multiple ingredients in combinations more
complex than those that would fit in the individual food groups. For
purposes of this rule, we refer to these foods as ``combination
foods.'' Combination foods are comprised of meaningful amounts of more
than one food group as described in more detail in the next few
paragraphs, and therefore are subject to different criteria in order to
bear the nutrient content claim ``healthy.''
The Dietary Guidelines, 2020-2025 food group recommendations are
discussed in section V.A (``Overview of Approach''). In that section,
we discussed the daily intake recommendations of each of the food
groups and subgroups (vegetables, fruits, grains, dairy, and protein
foods) in the ``Healthy U.S.-Style Dietary Pattern,'' and explained
that we are proposing that individual foods must contain at least one
food group equivalent to be eligible for ``healthy.'' We propose
similar requirements for combination foods, taking into account the
varying composition of food groups and subgroups they contain. The
nutrients-to-limit criteria for combination foods are also based on the
criteria for individual foods, depending on the number of food group
servings contained in the combination food. The food group equivalent
and nutrients-to-limit requirements for combination foods are discussed
in more detail below.
We are proposing different criteria for combination foods depending
on their role in the diet, which we have categorized into mixed
products, main dish products, and meal products:
Mixed products are similar in size to an individual food
but contain more than one food group. For example, a mixed product
could include a granola product that is half whole grains and half
nuts. We are proposing to require that a mixed product contain at least
half a food group equivalent each of two different food groups per
RACC. We are also proposing nutrients-to-limit requirements that
reflect the food group composition of mixed products.
Main dish products, defined at Sec. 101.13(m), are larger
in size (weighing at least 6 oz per labeled serving) than individual
foods and mixed products, and are intended to make a major contribution
to a meal. A main dish product might include, for example, a frozen
entr[eacute]e that is intended to be eaten with additional items to
form a full meal. Because of their size and purpose in the diet, we are
proposing to require that main dish products contain at least a food
group equivalent each of two different food groups per labeled serving.
We are also proposing specific nutrients-to-limit criteria to take into
account their purpose in the diet and their larger RACCs.
Meal products, defined at Sec. 101.13(l), are larger in
size (weighing at least 10 oz per labeled serving) than main dish
products, and are intended to comprise all of the food for a single
eating occasion (i.e., a full meal). An example of a meal would be a
frozen dinner. Because of their size and purpose in the diet, we are
proposing to require that meal products contain at least a food group
equivalent each from three different food groups per labeled serving.
We are also proposing nutrient-to-limit criteria to take into account
their purpose in the diet and their larger RACCs.
(2) Additional considerations for combination foods
There are a few special considerations that apply to all
combination foods. First, under the proposed criteria for combination
foods, oils do not count as a food group equivalent. This is because
oils are not considered a food group under the Dietary Guidelines,
2020-2025, but instead an element that should be included in a healthy
dietary
[[Page 59191]]
pattern as a substitute for fats high in saturated fat. Individual oil
products that are eligible to bear the ``healthy'' claim include 100
percent oil products, oil-based spreads, and oil-based dressings. This
category does not include oils as an ingredient in formulated foods
(e.g., foods fried in a vegetable oil). Thus, under the proposed
criteria for combination foods, oils are not considered a food group
equivalent. This does not mean that combination foods cannot contain
oils and still qualify for the ``healthy'' claim; it means that such
oils do not contribute to the food group equivalent requirements in
order to meet the criteria to be labeled ``healthy.'' We are proposing
saturated fat limits for combination foods to help encourage the use of
healthy oils instead of fats high in saturated fat in combination
foods.
Second, similar to the criteria for individual foods, we are
proposing that the saturated fat from nuts and seeds does not
contribute toward the saturated fat limit for nut and seed products.
This is because nuts and seeds are nutrient dense foods and consumption
of nuts and seeds has been found to be beneficial to health despite the
fact that some varieties contain levels of saturated fat that exceed
the limits set for other protein foods. Based on the scientific
evidence demonstrating beneficial effects of nut consumption, FDA has
multiple qualified health claims for nuts, and consumption of nuts and
seeds is encouraged by the Dietary Guidelines, 2020-2025, as discussed
in more detail in the individual foods section. Therefore, to make the
criteria for combination foods consistent with the criteria for
individual foods, we are proposing that when nuts and seeds are
included as ingredients in combination foods, the saturated fat
contained in the nuts and seeds does not contribute toward the
saturated fat limit. For example, for a mixed product that contains one
half serving of nuts and one half serving of whole grains, the food
would have a saturated fat limit of 5 percent DV, but the saturated fat
from nuts and seeds would not contribute to this limit.
Finally, we are proposing that beans, peas, and lentils may be
counted as either a protein food or as a vegetable in a combination
food. As noted previously, beans, peas, and lentils (which include
foods such as kidney beans, pinto beans, white beans, black beans,
garbanzo beans, lentils, and split peas) are considered both vegetables
and protein foods in the Dietary Guidelines, 2020-2025, because their
nutrient content is similar to both protein foods and to vegetables.
Consistent with the Dietary Guidelines, 2020-2025, we propose that
beans, peas, and lentils may count as either a vegetable or a protein
food in a combination food for purposes of food group equivalent
criteria. If a combination food has more than one type of food from the
beans, peas, and lentils subgroup, in amounts such that each food meets
the food group requirements individually, the amount of one food from
the beans, peas, and lentils subgroup can meet the vegetable group
requirement while another food from the same subgroup can be used to
meet the protein food requirement. However, if the food product has
only one type of food from the beans, peas, and lentils subgroup, the
one type cannot count toward both the vegetable and protein food group
requirements in the same combination food. For example, if a food
product had a \1/2\ cup of split peas and a \1/2\ cup of black beans,
the black beans could be counted as one food group equivalent of
protein foods and the split peas as one food group equivalent of
vegetables in a combination food. However, if a food product had one
cup only of black beans, it could be counted as one food group
equivalent of vegetables or one food group equivalent of protein foods,
but not as both.
(3) Combination foods criteria.
In addition to the special considerations just described, we are
proposing specific criteria for food group equivalents and nutrients to
limit for mixed products, main dishes, and meals. These criteria are
detailed in the following sections.
(i) Mixed products--Mixed products are foods that contain multiple
ingredients but do not contain a full food group equivalent per RACC of
any single Dietary Guidelines, 2020-2025 food group. A mixed product
could include, for example, a trail mix that contains fruit and nuts,
where neither of these components are in sufficient quantities to equal
a full food group equivalent. Where a product contains more than one
food group and does not contain a full food group equivalent of any one
food group, we are proposing that it can bear the ``healthy'' claim if
it contains a sufficient amount from two different food groups.
Specifically, we propose that a mixed product must contain at least
half of a food group equivalent each of two different food groups per
RACC. The amount in a food group equivalent is specified in proposed
Sec. 101.65(d)(2)(ii). For example, the aforementioned trail mix could
meet the food group equivalent requirement if it contains \1/4\ c-eq
fruit (half a fruit food group equivalent) and \1/2\ oz-eq nuts (half a
food group equivalent of nuts and seeds). One food group equivalent
equals \1/4\ of the total daily recommended amount of each of the
recommended food groups. For individual foods we have set a minimum
amount of one full FGE. For mixed products, we reduce this amount to
half of a food group equivalent in order to allow multi-component
foods, that contribute to meeting the daily recommended amounts of food
groups, to bear a ``healthy'' claim. For consumers who use the
``healthy'' claim in constructing their diets, mixed products bearing a
``healthy'' claim that contain less than half of a food group
equivalent may make it difficult for consumers to meet their total
daily amounts of recommended food groups. However, we request comments
on whether lower amounts of food group equivalents (e.g., \1/4\ FGE)
would be similarly effective as \1/2\ FGE in helping consumers meet
their total daily amounts of recommended food groups for multicomponent
foods.
We also propose that mixed products would have to meet certain
nutrients-to-limit criteria to bear the ``healthy'' claim. Because they
contain at least two half food group equivalents, mixed products
contain an overall food group equivalent similar to that of individual
foods. We calculated the nutrients-to-limit criteria for mixed products
by finding the average of the nutrients to limit for their component
food groups. For example, for a mixed product that contains a half food
group equivalent of dairy and a half food group equivalent of fruit,
the added sugars limit would be 2\1/2\ percent DV per RACC (the average
of 5 percent DV for dairy and 0 percent DV for fruit), sodium limit
would be 10 percent DV per RACC (as both food groups have the same
sodium limit), and the saturated fat limit would be 7\1/2\ percent DV
per RACC (the average of 10 percent DV for the dairy and 5 percent DV
for the fruit). Because there is variation in the saturated fat limits
for different subgroups of protein foods, the saturated fat limit for
mixed products containing protein also varies depending on the type of
protein in the product. The proposed nutrients to limit criteria per
RACC for each type of mixed product are reflected in table 9.
[[Page 59192]]
Table 9--Mixed Product Requirements
----------------------------------------------------------------------------------------------------------------
Added sugar
Food group equivalents (FGE) limit Sodium limit Saturated fat limit
----------------------------------------------------------------------------------------------------------------
\1/2\ FGE fruit, vegetable, or protein + \1/ 0% DV 10% DV 5% DV or 7\1/2\% DV if the protein
2\ FGE fruit, vegetable, or protein. is game meat, seafood, or egg.
\1/2\ FGE whole grain + \1/2\ FGE fruit, 2\1/2\% DV 10% DV 5% DV or 7\1/2\% DV if the protein
vegetable, or protein. is game meat, seafood, or egg.
\1/2\ FGE dairy + \1/2\ FGE fruit, 2\1/2\% DV 10% DV 7\1/2\% DV or 10% DV if protein is
vegetable, or protein. game meat, seafood, or egg.
\1/2\ FGE dairy + \1/2\ FGE whole grain.... 7\1/2\% DV 10% DV 7\1/2\% DV.
----------------------------------------------------------------------------------------------------------------
(ii) Main dish products--A main dish product is defined by our
regulations at Sec. 101.13(m) as a food that makes a major
contribution to a meal by weighing at least 6 oz per labeled serving;
and containing not less than 40 g of food, or combinations of foods,
from each of at least two food groups (as specified in Sec.
101.13(m)(1)(ii)). In addition to the food group requirements, the
product must be represented as, or in a form commonly understood to be,
a main dish (e.g., not a beverage or dessert). Such representations may
be made either by statements, photographs, or vignettes.
Main dish products are food products of significant size intended
to contain most of the components of a meal. Because of their size and
purpose in the diet, we propose that these types of food products must
contain at least one food group equivalent each of two different food
groups or subgroups as specified by proposed Sec. 101.65(d)(2)(ii).
These food group requirements are different and distinct from the food
groups specified in Sec. 101.13(m)(1)(ii). In particular, fruits and
vegetables are two separate food groups for the purposes of the
``healthy'' claim (where they are one combined food group under Sec.
101.13(m)(1)(ii)), consistent with the Dietary Guidelines, 2020-2025.
An example of a main dish product that might bear the ``healthy'' claim
would be a vegetable lasagna product that contains a \1/2\ c-eq of
mixed vegetables (vegetable food group equivalent) and \3/4\ oz-eq of
whole grains (whole grain equivalent) per labeled serving.
Main dish products would also be subject to specific nutrients-to-
limit criteria, which would apply per labeled serving. We calculated
the nutrients-to-limit criteria for main dish products by adding
together the nutrient limits for the two individual food groups that
make up the main dish. For example, for the vegetable lasagna main
dish, the added sugars limit would be 5 percent DV (5 percent DV for
whole grains plus 0 percent DV for vegetables), the sodium limit would
be 20 percent DV (10 percent DV for whole grains plus 10 percent DV for
vegetables), and the saturated fat limit would be 10 percent DV (5
percent DV for whole grains plus 5 percent DV for vegetable).
As with mixed products, because there is variation in the saturated
fat limits for different subgroups of protein foods, the saturated fat
limit for mixed products containing protein foods also varies depending
on the protein subcategory in the product. For example, a main dish
containing salmon and brown rice would have a higher saturated fat
limit (15 percent DV) than a main dish containing tofu and brown rice
(10 percent DV). The proposed nutrients to limit criteria per labeled
serving for each type of main dish product are reflected in table 10.
Table 10--Main Dish Requirements
----------------------------------------------------------------------------------------------------------------
Added sugar
Food group equivalents (FGE) limit Sodium limit Saturated fat limit
----------------------------------------------------------------------------------------------------------------
1 FGE fruit, vegetable, or protein + 1 FGE 0% DV 20% DV 10% DV or 15% DV if the protein is
fruit, vegetable, or protein. game meat, seafood, or egg.
1 FGE whole grain + 1 FGE fruit, vegetable, 5% DV 20% DV 10% DV or 15% DV if the protein is
or protein. game meat, seafood, or egg.
1 FGE dairy + 1 FGE fruit, vegetable, or 5% DV 20% DV 15% DV or 20% DV if protein is game
protein. meat, seafood, or egg.
1 FGE dairy + 1 FGE whole grain............ 10% DV 20% DV 15% DV.
----------------------------------------------------------------------------------------------------------------
(iii) Meal products--A meal product is defined by our regulations
at Sec. 101.13(l) as a food that makes a major contribution to the
total diet by weighing at least 10 oz per labeled serving and
containing no less than three 40 g portions of food, or combinations of
foods, from two or more of the food groups specified at Sec.
101.13(l)(1)(ii). In addition to the food group contribution
requirements, the product must be represented as, or must be in a form
commonly understood to be, a breakfast, lunch, dinner, or meal. As with
main dishes, such representations may be made either by statements,
photographs, or vignettes.
For a meal product to be eligible to bear the ``healthy'' claim, we
propose in Sec. 101.65(d)(3)(iv) that it must contain at least one
full food group equivalent each of three different food groups or
subgroups specified by the proposed regulation in Sec. 101.65(d)(2)(i)
through (iv) (vegetable, fruit, whole grain, dairy, or protein foods)
per labeled serving. As with main dish products, these food group
requirements are different and distinct from the food groups in Sec.
101.13(l)(1)(ii). An example of a meal product containing the necessary
food group equivalents to bear the ``healthy'' claim would be a frozen
salmon dinner containing 1 oz-eq salmon, \1/2\ c-eq green beans, and
\3/4\ oz-eq brown rice, representing a food group equivalent each of
seafood (protein food), vegetables, and whole grains.
As with mixed products and main dish products, meal products would
also be subject to specific nutrients-to-limit criteria, which would
apply per labeled serving. The nutrients-to-limit criteria for meals
are the sum of the requirements for the three individual food groups
that comprise the meal. For example, in the salmon meal, the added
[[Page 59193]]
sugars limit would be 5 percent DV (0 percent DV for vegetable, 0
percent DV for seafood, and 5 percent DV for whole grain), the sodium
limit would be 30 percent DV (10 percent DV each for vegetable,
seafood, and whole grain), and the saturated fat limit would be 20
percent DV (5 percent DV for vegetable, 10 percent DV for seafood, and
5 percent DV for whole grain).
As with mixed products and main dish products, because there is
variation in the saturated fat limits for different subgroups of
protein foods, the saturated fat limit for mixed products containing
protein foods also varies depending on the protein subcategory in the
product. The proposed nutrients-to-limit criteria per labeled serving
for each type of meal product are reflected in table 11.
Table 11--Meal Product Requirements
----------------------------------------------------------------------------------------------------------------
Added sugar
Food group equivalents (FGE) limit Sodium limit Saturated fat limit
----------------------------------------------------------------------------------------------------------------
1 FGE fruit, vegetable, or protein + 1 FGE 0% DV 30% DV 15% DV or 20% DV if the protein is
fruit, vegetable, or protein + 1 FGE game meat, seafood, or egg.
fruit, vegetable, or protein.
1 FGE whole grain + 1 FGE fruit, vegetable, 5% DV 30% DV 15% DV or 20% DV if the protein is
or protein + 1 FGE fruit, vegetable, or game meat, seafood, or egg.
protein.
1 FGE dairy + 1 FGE fruit, vegetable, or 5% DV 30% DV 20% DV or 25% DV if protein is game
protein + 1 FGE fruit, vegetable, or meat, seafood, or egg.
protein.
1 FGE dairy + 1 FGE whole grain + 1 FGE 10% DV 30% DV 20% DV or 25% DV if the protein is
fruit, vegetable, or protein. game meat, seafood, or egg.
----------------------------------------------------------------------------------------------------------------
(iv) Water--We are proposing to include plain and plain, carbonated
water in the updated definition of ``healthy.'' According to the
National Academies (Ref. 23), water is the largest single constituent
of the human body and is essential for cellular homeostasis and life.
It provides the solvent for biochemical reactions, is the medium for
material transport, and has unique physical properties (high specific
heat) to absorb metabolic heat. Water is essential to maintain vascular
volume, to support the supply of nutrients to tissues, and to remove
waste. Body water deficits challenge the ability of the body to
maintain homeostasis during perturbations (e.g., sickness, physical
exercise, or climatic stress) and can impact function and health (Ref.
23). The total water intake needed to prevent the deleterious effects
of dehydration comes from drinking water, water in other beverages, and
water (moisture) in food. Approximately 80 percent of total water
intake comes from drinking water and other beverages.
Water itself is not categorized under a recommended food group in
the Dietary Guidelines, 2020-2025. However, water is emphasized in the
Dietary Guidelines, 2020-2025 beverage recommendations. The Dietary
Guidelines, 2020-2025 recommends that the ``primary beverages
consumed'' should be ``beverages that are calorie-free--especially
water--or that contribute beneficial nutrients, such as fat-free and
low-fat milk and 100 percent fruit juice'' (Ref. 1). Organizations,
such as the National Academy of Medicine, and public health agencies,
such as the Centers for Disease Control and Prevention, widely
recognize the benefits of water, that it is a preferred source of
hydration, and is necessary for proper functioning of the human body,
and, accordingly, recommend increased availability of drinking water
(Refs. 24-26).
Under the existing regulation at Sec. 101.65(d), water cannot be
labeled ``healthy'' because it does not meet the existing nutrient-
related criteria. Beverages included in a healthy dietary pattern, such
as water, are those that allow nutrient needs to be met through the
dietary pattern by allowing consumers to meet the food group
recommendations without exceeding calorie needs. Thus, consideration of
water under the ``healthy'' claim is appropriate as water is an
important beverage for maintaining healthy dietary practices due to its
nutrient content and how the profile affects the overall dietary
pattern. Further, the Dietary Guidelines, 2020-2025 recommends making
shifts toward healthier food and beverage choices, such as choosing
water in the place of sugar-sweetened beverages and emphasize choosing
nutrient-dense foods to help achieve healthy dietary patterns within
calorie limits. To help achieve this, the Dietary Guidelines, 2020-2025
further recommends limiting added sugars in the diet, since a healthy
dietary pattern within calorie limits is difficult to achieve when
added sugars exceed 10 percent of calories. The major source of added
sugars in the typical U.S. diet is beverages, including sugar-sweetened
beverages and sweetened coffees and teas, which account for 35 percent
of all added sugars consumed by the U.S. population (Ref. 1). Thus, the
absence of added sugars is particularly relevant to inclusion of water
when defining the implied nutrient content claim ``healthy.'' Further,
the Dietary Guidelines, 2020-2025 recommends selecting calorie-free
beverages, such as water, to help achieve a healthy dietary pattern
within calorie limits.
In addition, the Dietary Guidelines, 2020-2025 specifically calls
out water, 100 percent fruit juice, and fat-free/low-fat milk as
beverages to consume in a healthy dietary pattern. As discussed
previously, 100 percent vegetable juice, 100 percent fruit juice, and
fat-free and low-fat milk are eligible to bear the nutrient content
claim ``healthy'' under this proposed rule; therefore, it would be
consistent with a healthy dietary pattern to also allow water to bear
the ``healthy'' claim. Moreover, the Dietary Guidelines, 2020-2025
recommends water without restriction, in contrast to milk and 100
percent juice beverages, which should be consumed in the context of the
recommended intake amounts of each individual food group and within
calorie limits.
Based on these considerations, we propose including plain water--
both still and carbonated--in the definition of ``healthy.'' We seek
comment on whether water should be included in the definition, and
whether ``water'' should be expanded, for example, to include waters
containing non-caloric flavors or other non-caloric ingredients. In
addition, because only labeled water (e.g., bottled water) would
commonly bear the ``healthy'' claim, we also seek comment on whether
allowing bottled water to be labeled ``healthy'' could potentially lead
some consumers to believe that bottled water is healthier than tap
water. Beyond water, the Dietary Guidelines, 2020-2025 states that
beverages that are calorie-free should be primary beverages consumed
and that coffee and tea with little, if any, sweeteners or cream are
also beverage options that can be part of a healthy
[[Page 59194]]
dietary pattern. Therefore, we also seek comment on the eligibility of
calorie-free beverages, coffee, and tea to bear the ``healthy'' claim.
4. Records Requirements
We are proposing limited recordkeeping requirements on
manufacturers to facilitate FDA's ability to verify compliance with
certain aspects of the proposed rule. See section V. (``Legal
Authority'') for the discussion of our legal authority for proposing
recordkeeping and records access requirements. Compliance with the
requirements for nutrients to limit will be verifiable for all food
products using the Nutrition Facts Label; that is, it will be apparent
from the Nutrition Facts Label whether a food meets the applicable
criteria for saturated fat, sodium, and added sugars content, and thus
no additional records are required. For some foods, we will also be
able to use the product label (including the Nutrition Facts Label, the
ingredient list, the statement of identity, and any other information)
to verify compliance with the food group requirements. For example, it
would be apparent from the ingredient list of an oil product whether
the product contains 100 percent oil. Similarly, it would likely be
ascertainable from the ingredient list of a frozen spinach product that
contains only spinach and salt whether the product contains enough
spinach (vegetable food group) to bear the ``healthy'' claim.
However, for certain foods bearing the ``healthy'' claim, the label
will not be sufficient to verify that the food meets the requirements
for ``healthy'' as described in Sec. 101.65(d)(3). Specifically, the
label will not provide sufficient information for FDA to verify that
certain foods containing multiple components (such as most grain
products and all combination foods) meet the food group equivalent
requirements to bear the claim. For these foods, we are proposing to
require recordkeeping to demonstrate compliance with the food group
equivalent requirements, given the nature of the information necessary
to determine compliance and the number of foods potentially affected.
We are proposing to require the manufacturer of a food bearing the
implied nutrient content claim ``healthy'' to make and keep records,
identified in proposed Sec. 101.65(d)(4), where the food group
equivalent(s) is/are not apparent based on the label of the food. These
records would verify that the food bearing the ``healthy'' claim meets
the food group equivalent requirements. This recordkeeping requirement
would not apply to water or to raw, whole fruits and vegetables, which
do not have food group equivalent requirements.
This recordkeeping requirement would always apply to manufacturers
of mixed products, main dish products, and meal products, as these
products contain multiple components and it will not be clear how much
of each food group is contained in the products without additional
information. For individual foods, it will depend on the food whether
such records are required. For example, a manufacturer of a multigrain
bread containing both whole wheat and refined wheat flours would be
required to keep records under this section. This is because it would
not be apparent based on the label whether a serving of the bread
contains at least \3/4\ oz-equivalent of whole grains. By contrast, a
manufacturer would not be required to keep such records for a 100
percent whole wheat bread, because the ingredient statement on the
information panel would indicate that the bread contains only whole-
grain flour, and therefore, it would be apparent from the label that
the bread contains the required \3/4\ oz-eq of whole grains (as one
slice of whole wheat bread would be a 1 oz-eq of whole grains). Other
examples of individual foods that would not be subject to the
recordkeeping provision include dried fruit, plain yogurt, and brown
rice.
Where the proposed requirements cannot be verified using the label,
only the manufacturer will have the information required to determine
whether the product meets the food group equivalent requirements for
bearing the ``healthy'' claim. The information contained in
manufacturers' records is an accurate and practical method for ensuring
that the nutrient content claim is used in accordance with Sec.
101.65(d) and that the food labeling complies with section 403(r) of
the FD&C Act. We tentatively conclude that the records will provide FDA
with the necessary means to determine compliance with the food group
equivalent requirements for bearing the ``healthy'' nutrient content
claim.
Manufacturers will be responsible for the type of records they
maintain and are not required to produce any specific form or document.
The manufacturer is in the best position to know which of its records
provide the documentation required to determine compliance. Records
used to verify that a food meets the food group equivalent requirements
for ``healthy'' could include recipes or formulations, batch records
providing data on the weight of certain ingredient contributions to the
total batch, certificates of analysis from ingredient suppliers, or
other appropriate verification documentation that provides the needed
assurance that a food bearing the ``healthy'' claim complies with the
food group equivalent requirements. We expect that manufacturers
choosing to use the ``healthy'' claim will have the type of records
needed to verify that the food meets the requirements, given that they
will have to analyze their product to determine whether it meets the
requirement in order to bear the claim. The proposed records
requirement is intended to provide flexibility in what records the
manufacturer makes available to FDA to verify the claim. The records
provided during an inspection by FDA would only need to provide
information on the food group equivalents because the information on
nutrients to limit will be available on the food package. Other
information about the food can be redacted if necessary to ensure
confidentiality of a food product formulation.
We recognize that the composition of processed foods can vary
depending on the recipe or formulation, the suppliers of ingredients,
etc. For example, the amounts of given components in a mixed product,
such as granola, may change if a manufacturer changes ingredient
suppliers or changes a recipe. In order to verify the composition of a
packaged food, the manufacturer would need to ensure that the records
it provides to us to verify that the food bearing the ``healthy'' claim
meets the food group equivalent requirements of Sec. 101.65(d)(3),
and, as appropriate, can distinguish among the same or similar product
that the manufacturer has in the marketplace that may contain differing
amounts of its components. For example, the manufacturer may have to
distinguish among different granola bars with different amounts of
qualifying food groups or the same granola with different formulations.
Although some manufacturers may have large numbers of foods bearing
the ``healthy'' claim that would necessitate recordkeeping to verify
that they meet the requirements, we do not think that determining the
composition of the foods and maintaining that information would present
undue difficulty for manufacturers. With or without a ``healthy''
claim, manufacturers are required to know what ingredients and
nutrients are in the foods they produce and to provide that information
truthfully to consumers. Manufacturers have experience with determining
the ingredient composition of the food they produce and with the
maintenance of related records, either written or
[[Page 59195]]
electronic. We seek comment on the accuracy of these assumptions.
We recognize that manufacturers frequently obtain ingredients from
suppliers in a (sometimes extensive) supply chain, and that these
ingredients often contain multiple ingredients themselves.
Manufacturers should be able to work with their suppliers to obtain the
necessary information to ensure that any food bearing the claim
``healthy'' meets the regulatory requirements to bear the claim.
Ingredient suppliers should know the contents of the ingredients they
provide to food manufacturers, and this information will need to be
properly communicated.
We are proposing that such records must be kept for a period of 2
years after introduction or delivery for introduction of the food into
interstate commerce. We selected this period to ensure that records can
be made available for review and copying as long as the product is
available for purchase in the marketplace. Due to the significant
number of packaged food products in the marketplace that could meet the
requirements under Sec. 101.65(d), we recognize that there could be a
wide variation of manufacturing practices, shipping practices, and
shelf lives among packaged foods bearing the ``healthy'' claim. We
believe that it is most practical to establish a single recordkeeping
period for this provision rather than establishing different
recordkeeping periods for different products or for different
manufacturing or shipping practices. It would be more difficult for FDA
to establish a compliance program for one segment of the regulated
industry that starts the recordkeeping process when the food is made,
and a different compliance program for another segment of the industry
that starts the recordkeeping process when the food is shipped. For
manufacturers who make several food products, we expect it would be
easier for them to use the same recordkeeping period for all products
rather than use different recordkeeping periods for different products.
Therefore, we have designed a compliance program that involves a single
recordkeeping period. The proposed record requirements for purposes of
verifying the ``healthy'' claim are separate and distinct from other
record requirements.
We are proposing that records must be made available to us for
examination or copying during an inspection upon request; this is
consistent with our other recordkeeping regulations (see, e.g., 21 CFR
111.605 and 111.610, and 81 FR 33742). The records would need to be
reasonably accessible (access to records within 24 hours can be
considered reasonable) to FDA during an inspection at each
manufacturing facility (even if not stored onsite) to determine whether
the food meets the requirements for bearing the ``healthy'' claim.
Records that can be immediately retrieved from another location by
electronic means are considered reasonably accessible.
We anticipate that manufacturers may have concerns about the
confidentiality of the information inspected by us under this proposal.
We would protect confidential information from disclosure, consistent
with applicable statutes and regulations, including 5 U.S.C. 552(b)(4),
18 U.S.C. 1905, and 21 CFR part 20. Thus, we are proposing to require
that manufacturers must make and keep records to verify that the food
meets the food group equivalent requirements of Sec. 101.65(d)(2)
where the food group equivalent contained in the product is not
apparent based on the label of the food.
We are also proposing, in Sec. 101.65(d)(4), that such records
must be kept for a period of 2 years after introduction or delivery for
introduction of the food into interstate commerce. In addition, we are
proposing to require that such records must be provided upon request,
during an inspection, for official review and photocopying or other
means of reproduction, and that records may be kept either as original
records, true copies (such as photocopies, pictures, scanned copies,
microfilm, microfiche, or other accurate reproductions of the original
records), or electronic records. All electronic records that are
maintained to comply with the proposed requirements would need to
comply with 21 CFR part 11.
We seek comment on the proposed requirements for the types of
records that must be made and kept and the length of time that the
records must be kept.
VII. Proposed Effective and Compliance Dates
We intend that any final rule resulting from this rulemaking become
effective 60 days after the date of the final rule's publication in the
Federal Register with a compliance date 3 years after the effective
date. We recognize that it may take industry time to analyze products,
update their records of product labels, and print new labels. A
compliance date that is 3 years after the effective date is intended to
provide industry time to revise labeling to come into compliance with
the new labeling requirements while balancing the need for consumers to
have the information in a timely manner. We seek comment on the
proposed compliance date.
VIII. Preliminary Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
The Office of Information and Regulatory Affairs has designated this
proposed rule to be an economically significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because a large proportion of covered entities are small
businesses, we find that the proposed rule will have a significant
economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
result in an expenditure in at least one year that meets or exceeds
this amount.
B. Summary of Costs and Benefits
Some consumers use nutrient content claims such as ``healthy'' to
inform their food purchases. We estimate that a small number (0 to 0.4
percent of people that try to follow current dietary guidelines) of
these consumers would use the ``healthy'' implied nutrient content
claim to make meaningful, long-lasting food purchasing decisions. If
the foods using the ``healthy'' claim more closely align with Federal
dietary guidance, the claim can assist consumers who are selecting
those products in choosing a more healthful diet, which may result in
lower chronic, diet-related diseases, including
[[Page 59196]]
cardiovascular disease and type 2 diabetes.
Quantifiable benefits of the proposed rule are the estimated
reduction over time in all-cause morbidity stemming from consumers
selecting and consuming more healthful foods. This is calculated
through the negative association between a Healthy Eating Index score
and all-cause mortality. Discounted at three percent over 20 years, the
mean present value of benefits accrued to consumers using the
``healthy'' nutrient content claim is $455 million, with a lower bound
estimate of $15 million and an upper bound estimate of $1.3 billion.
Discounted at seven percent over 20 years, the mean present value of
benefits of the proposed rule is $290 million, with a lower bound
estimate of $9 million and an upper bound estimate of $857 million.
Quantified costs to manufacturers associated with updating the
``healthy'' claim are labeling, reformulating, and recordkeeping.
Overall, about 34,000 UPCs, or 14 percent of total UPCs, qualify for
the existing ``healthy'' implied nutrient content claim but only 5
percent (12,000 UPCs) choose to label. The use of the ``healthy''
nutrient content claim is voluntary, but if the proposed rule results
in some products needing to remove the claim to avoid being misbranded,
manufacturers would incur costs due to the rule. Manufacturers with
food products currently using the ``healthy'' nutrient content claim
would need to confirm whether the products meet the proposed criteria
and decide whether a label change is needed. Manufacturers with
products that currently do not meet the ``healthy'' criteria but do
meet the proposed criteria have the option of labeling these products.
In some cases, manufacturers may choose to reformulate a product so
that it meets the proposed criteria. Some recordkeeping is required for
certain products using the proposed ``healthy'' claim because the
required food components equivalents are likely to increase time spent
on recordkeeping. It is possible that manufacturers of products that
include the term ``healthy'' within the brand name may choose to
rebrand products instead of reformulating. We lack the data to quantify
this effect but discuss it qualitatively. Discounted at three percent
over 20 years, the mean present value of costs accrued to manufacturers
using the ``healthy'' nutrient content claim, assuming the current 5
percent adoption rate, is $276 million, with a lower bound of $128
million and an upper bound of $505 million. Discounted at seven percent
over 20 years, the mean present value of costs of the proposed rule is
$237 million, with a lower bound of $110 million and an upper bound of
$434 million.
Table 12--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
[In millions 2020$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
Primary Low High ------------------------------------
Category estimate estimate estimate Year Discount Period Notes
dollars rate (%) covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year....... $27.4 $0.89 $80.9 2020 7 20 Monetized benefits account for
30.6 0.99 90.4 2020 3 20 consumer's lost pleasure from
eating less healthy foods they
may nevertheless prefer.
Annualized Quantified..................... .......... .......... .......... .......... 7 .......... ................................
3
---------------------------------------------------------------------------------------------------------
Qualitative............................... To the extent consumers use the ``healthy'' nutrient content claim to ................................
maintain healthy dietary practices, following a healthy diet could
reduce the risk of morbidity and prolong life.
---------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year....... 22.3 10.4 40.9 2020 7 20 ................................
18.5 8.6 33.9 2020 3 20
Annualized Quantified..................... .......... .......... .......... .......... 7 .......... ................................
3
Qualitative............................... .......... .......... .......... .......... .......... .......... ................................
Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7 .......... ................................
year. 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To................................... From:
To: ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/year..... .......... .......... .......... .......... 7 .......... ................................
3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To................................... From:
To: ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None...
[[Page 59197]]
Distributional: American Indian, Alaskan
Native, Hispanic, and Non-Hispanic Black
adults and children, as well as the lower-
income or publicly insured may accrue a
larger proportion of the estimated health
benefits. However, this distributional
shift may be reduced if these populations
do not use, or do not have access to,
products that bear the ``healthy''
nutrient content claim to meaningfully
change their diet. Finally, any
distributional shift may be dampened if
costs are passed onto consumers in the
form of increased prices of foods labeled
as ``healthy''. Small Business: Potential
impacts on small manufacturers of
packaged food and beverages due to
removing the ``healthy'' claim or
reformulating some products.
Wages: None...............................
Growth: None..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
We seek comment on our estimates of costs and benefits of this
proposed rule.
We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 26) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
IX. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(k) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
X. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A
description of these provisions is given in the Description section of
this document with an estimate of the annual recordkeeping and third-
party disclosure burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA seeks comments on these topics: (1) whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Food Labeling Regulations, OMB Control Number 0910-0381--
Revision.
Description of Respondents: The respondents to this information
collection are manufacturers of food products using the ``healthy''
implied nutrient content claim marketed in the United States.
Description: The proposed rule would revise Sec. 101.65(d) to
require manufacturers using the ``healthy'' implied nutrient content
claim on their products to make and keep written records to verify that
the products comply with this requirement. Examples of these records
include analyses of databases, recipes, formulations, information from
recipes or formulations, or batch records. Manufacturers must provide
these records upon request from FDA during an inspection for official
review and photocopying or other means of reproduction.
The proposed rule would also require some manufacturers to relabel
products to comply with the criteria for the ``healthy'' implied
nutrient content claim. A product that does not meet the criteria would
need to have the term removed from its label, and a product that became
eligible would be permitted to use the term in its label.
We estimate the recordkeeping burden of this collection of
information as follows:
[[Page 59198]]
Table 13--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.65; recordkeeping to verify 1,839 1 1,839 0.5 (30 minutes)........................ 920
``healthy'' nutrient content claim.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The proposed rule requires that each manufacturer of a food that
bears the implied nutrient content claim ``healthy'' must make and keep
written records to verify that the food meets the food group equivalent
requirements when it is not apparent from the label of the food.
Examples of records include analyses of databases, recipes,
formulations, information from recipes or formulations, or batch
records. However, the product label (including the Nutrition Facts
label (NFL), the ingredient list, the statement of identity, and any
other information) may be used to verify compliance with the food group
requirements for certain foods. For example, it would be apparent from
the ingredient list of an oil product whether the product contains 100
percent oil. Similarly, it would likely be ascertainable from the
ingredient list of a frozen spinach product that contains only spinach
and salt whether the product contains enough spinach (vegetables) to
bear the ``healthy'' claim. Thus, this recordkeeping estimate does not
include food groups where the equivalent requirements are apparent from
the label of the food. The estimates in table 13 are based on the 5,516
products estimated to need recordkeeping in table 11 of the Preliminary
Regulatory Impact Analysis (PRIA) (Ref. 26). A PRA analysis covers a 3-
year period, so this number is divided by 3 to get 1,839 as an annual
number of records maintained (1 record for each product). In table 13,
FDA estimates that each year 1,839 manufacturers will each make and
keep 1 written record for a total of 1,839 records. We estimate that
each record will require 15 to 30 minutes of recordkeeping for an
annual recordkeeping burden of 919.5 hours, rounded to 920 (1,839
records x 0.5 hour).
Table 14--Estimated One-Time Relabeling Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures per Total annual Average burden Total hours Total capital
respondents respondent disclosures per disclosure costs \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Relabel for ``healthy'' claim..................... 5,987 1 5,987 1 5,987 $14,715,909
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ One-time labeling burden.
\2\ There are no operating and maintenance costs associated with this collection of information.
We assume there are two categories of UPCs that could require re-
labeling. First, if a UPC currently labeled ``healthy'' does not meet
the proposed criteria, the manufacturer could choose to remove the
``healthy'' claim or reformulate. In either case, the label would need
to be changed, either to remove the ``healthy'' claim or to change the
NFL after reformulation. Given the current UPCs labeled ``healthy''
that would not qualify for the proposed criteria, we estimate the
number of UPCs that would remove the ``healthy'' claim or reformulate.
Second, if a UPC does not currently qualify as ``healthy'' but would
meet the proposed criteria, the manufacturer could choose to add the
``healthy'' claim. Table 7 of the PRIA estimates the need for 17,960
total label changes. Because this claim is voluntary, we do not know
how many establishments will make labeling changes. For the purpose of
this analysis, we assume that the number of respondents is the same as
the number of disclosures.
We estimate that each manufacturer will relabel 1 product. A PRA
analysis covers a 3-year period, so the total number of label changes,
17,960, is divided by 3 to get 5,987 annual disclosures. Each
disclosure will take an estimated 1 hour to complete for an annual
third-party disclosure burden of 5,987 hours. Based on table 7 of the
PRIA, we estimate that there will be an annual capital cost of
$14,715,909 over 3 years associated with relabeling with the total
capital cost being $44,147,727. This is the cost of designing a revised
label and incorporating it into the manufacturing process. We believe
that this will be a one-time burden.
To ensure that comments on this information collection are
received, OMB recommends that written comments be submitted through
reginfo.gov (see ADDRESSES). All comments should be identified with the
title of the information collection.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), we have submitted the information collection provisions of
this proposed rule to OMB for review. These information collection
requirements will not be effective until FDA publishes a final rule,
OMB approves the information collection requirements, and the rule goes
into effect. FDA will announce OMB approval of these requirements in
the Federal Register.
XI. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe . . . a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.''
Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express
preemption provision. Section 403A(a) of the FD&C Act provides, with
minor exceptions, that no State or political subdivision of a State may
directly or indirectly establish under any authority or continue in
effect as to any food in interstate commerce with respect to any
requirement for nutrition labeling of food that is not identical to
[[Page 59199]]
requirements established under section 403(r) of the FD&C Act.
The express preemption provision of section 403A(a) of the FD&C Act
does not preempt any State or local requirement respecting a statement
in the labeling of food that provides for a warning concerning the
safety of the food or component of the food (section 6(c)(2) of the
Nutrition Labeling and Education Act of 1990, Public Law 101-535
(1990)); however, it is possible that such a requirement could be
preempted on another basis, such as under principles of implied
preemption. If this proposed rule is made final, the final rule would
create requirements that fall within the scope of section 403A(a) of
the FD&C Act.
XII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. We solicit comments from tribal officials
on any potential impact on Indian Tribes from this proposed action.
XIII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
1. U.S. Department of Agriculture and U.S. Department of Health
and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th
Edition. December 2020. Available at DietaryGuidelines.gov.
2. * Centers for Disease Control and Prevention. National Center
for Chronic Disease Prevention and Health Promotion. Retrieved from:
https://www.cdc.gov/chronicdisease/index.htm.
3. * Centers for Disease Control and Prevention. National Center
for Health Statistics. ``Leading Causes of Death.'' Retrieved from:
https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm.
4. Lloyd-Jones, D., R.J. Adams, T.M. Brown, et al. ``Heart
Disease and Stroke Statistics--2018 Update: A Report from the
American Heart Association.'' Circulation,137:e67-e492, 2018. DOI:
10.1161/CIR.0000000000000558.
5. * Centers for Disease Control and Prevention. ``National
Diabetes Statistics Report, 2017.'' Retrieved from: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
6. * National Cancer Institute. Surveillance, Epidemiology, and
End Results (SEER) Program. ``Cancer Stat Facts: Cancer of Any
Site.'' Retrieved from: https://seer.cancer.gov/statfacts/html/all.html.
7. IOM of the National Academies. ``Dietary Reference Intakes
for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol,
Protein, and Amino Acids (Macronutrients), Chapter 8: Dietary Fats:
Total Fat and Fatty Acids'': Washington, DC: National Academies
Press; 2002.
8. IOM of the National Academies. ``Sodium Intake in
Populations: Assessment of Evidence,'' Washington, DC: National
Academies Press; 2013, pp. 235-284.
9. IOM of the National Academies. ``Dietary Reference Intakes
for Water, Potassium, Sodium, Chloride, and Sulfate, Chapter 6:
Sodium and Chloride,'' Washington, DC: National Academies Press;
2005. pp. 269-423.
10. * National Heart, Lung, and Blood Institute. ``Managing
Overweight and Obesity in Adults: Systematic Evidence Review from
the Obesity Expert Panel, 2013.'' Retrieved from: https://www.nhlbi.nih.gov/sites/default/files/media/docs/obesity-evidence-review.pdf.
11. * Centers for Disease Control and Prevention. NCHS health E-
stats. Retrieved from: https://stacks.cdc.gov/view/cdc/58670 and
https://stacks.cdc.gov/view/cdc/58669.
12. * HHS and USDA. ``Dietary Guidelines for Americans, 2005.''
6th Edition, Washington, DC: U.S. Government Printing Office,
January 2005. Retrieved from: https://health.gov/sites/default/files/2020-01/DGA2005.pdf.
13. * FDA. ``Public Meeting to Discuss Use of the Term
``Healthy'' in Food Labeling.'' Docket FDA-2016-D-2335. Retrieved
from: https://www.fda.gov/food/newsevents/workshopsmeetingsconferences/ucm539060.htm.
14. * USDA. A Brief History of USDA Food Guides. Retrieved from:
https://www.choosemyplate.gov/brief-history-usda-food-guides.
15. * USDA and HHS. ``Dietary Guidelines for Americans, 2010,''
7th Ed., Washington DC: U.S. Government Printing Office, January
2010. Retrieved from: https://health.gov/dietaryguidelines/DGA2010/DietaryGuidelines2010.pdf.
16. * Dietary Guidelines Advisory Committee. 2020. Scientific
Report of the 2020 Dietary Guidelines Advisory Committee: Advisory
Report to the Secretary of Agriculture and the Secretary of Health
and Human Services. U.S. Department of Agriculture, Agricultural
Research Service, Washington, DC. Retrieved from: https://www.dietaryguidelines.gov/2020-advisory-committee-report.
17. * The National Academies of Sciences, Engineering, and
Medicine: Health and Medicine Division. ``Review of the Dietary
Reference Intakes for Sodium and Potassium.'' Retrieved from: http://nationalacademies.org/hmd/Activities/Nutrition/ReviewDRIforSodiumandPotassium.aspx.
18. Antman, E.M., L.J. Appel, D. Balentine, R.K. Johnson, et al.
``Stakeholder Discussion to Reduce Population-Wide Sodium Intake and
Decrease Sodium in the Food Supply: A Conference Report from the
American Heart Association Sodium Conference 2013 Planning Group.''
Circulation. 2014 Jun 24;129(25):e660-79. doi:10.1161/
CIR.0000000000000051.
19. * FDA. ``Use of the Term ``Healthy'' in the Labeling of
Human Food Products: Guidance for Industry.'' September 2016.
Retrieved from: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf.
20. * USDA, Agricultural Research Service, Nutrient Data
Laboratory. USDA National Nutrient Database for Standard Reference,
Legacy. Version Current: April 2018. Retrieved from: https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/nutrient-data-laboratory/docs/usda-national-nutrient-database-for-standard-reference/.
21. * Dietary Guidelines Advisory Committee. 2020. Scientific
Report of the 2020 Dietary Guidelines Advisory Committee: Advisory
Report to the Secretary of Agriculture and the Secretary of Health
and Human Services--Food Pattern Modeling Supplements. U.S.
Department of Agriculture, Agricultural Research Service,
Washington, DC. Retrieved from: https://www.dietaryguidelines.gov/2020-advisory-committee-report/food-pattern-modeling.
22. Coates, A.M., A.M. Hill, and S.Y. Tan. ``Nuts and
Cardiovascular Disease Prevention.'' Current Atherosclerosis
Reports, 20:48, 2018. Retrieved from: https://doi.org/10.1007/s11883-018-0749-3.
23. IOM of the National Academies. ``Dietary Reference Intakes
for Water, Potassium, Sodium, Chloride, and Sulfate, Chapter 4:
Water,'' Washington, DC: National Academies Press; 2005.
24. Popkin, B.M., K.E. D'Anci, and I.H. Rosenberg. ``Water,
Hydration and Health.'' Nutrition Reviews, 68(8):439-458, 2010.
doi:10.1111/j.1753-4887.2010.00304.x.
25. * Centers for Disease Control and Prevention. Division of
Nutrition, Physical Activity, and Obesity. ``Get the Facts: Drinking
Water and Intake.'' Retrieved from: https://www.cdc.gov/nutrition/data-statistics/plain-water-the-healthier-choice.html.
26. * FDA. Regulatory Impact Analysis for Proposed Rule:
Nutrient Content Claims; Definition of Term ``Healthy.'' 2018.
Retrieved from: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
27. Ostchega, Y., C.D. Fryar, T. Nwankwo, and D.T. Nguyen.
Hypertension Prevalence
[[Page 59200]]
Among Adults Aged 18 and Over: United States, 2017-2018. NCHS Data
Brief, no 364. Hyattsville, MD: National Center for Health
Statistics. 2020. Retrieved from: https://www.cdc.gov/nchs/data/databriefs/db364-h.pdf.
28. Centers for Disease Control and Prevention. National
Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease
Control and Prevention, U.S. Dept of Health and Human Services;
2020. Retrieved from: https://www.cdc.gov/diabetes/data/statistics-report/index.html.
29. Government Accountability Office, Chronic Health
Conditions--Federal Strategy Needed to Coordinate Diet-Related
Efforts. August 17, 2021. Retrieved from: https://www.gao.gov/products/gao-21-593.
30. * Questions and Answers on FDA's Fortification Policy,
Guidance for Industry. 2015. Retrieved from: https://www.fda.gov/media/94563/download.
31. * FDA. Sodium Reduction. Retrieved from: www.fda.gov/SodiumReduction.
32. Facts Up Front. Retrieved from: http://www.factsupfront.org/.
33. Bitok, E. and J. Sabate. ``Nuts and cardiovascular
disease.'' Progress in Cardiovascular Diseases, 61(1):33-37, 2018.
doi: 10.1016/j.pcad.2018.05.003.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and record keeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, FDA
proposes to amend 21 CFR part 101 as follows:
PART 101--FOOD LABELING
0
1. The authority citation for part 101 continues to read as follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
0
2. Revise Sec. 101.13(b)(2)(ii) to read as follows:
Sec. 101.13 Nutrient content claims--general principles.
* * * * *
(b) * * *
(2) * * *
(ii) Suggests that a food, because of its nutrient content, may be
useful in maintaining healthy dietary practices, where there is also
implied or explicit information about the nutrition content of the food
(e.g., healthy).
* * * * *
0
3. Revise Sec. 101.65(d) to read as follows:
Sec. 101.65 Implied nutrient content claims and related label
statements.
* * * * *
(d) General nutritional claims. (1) This paragraph (d) covers
labeling claims that are implied nutrient content claims because they
suggest that a food may help consumers maintain healthy dietary
practices due to its nutrient content, where there is also implied or
explicit information about the nutrition content of the food.
(2) For purposes of this section, a ``food group equivalent'' is
the minimum amount of a food group that must be contained in a food for
it to bear the ``healthy'' implied nutrient content claim. Food group
equivalents identify the amounts of foods from each food group with
qualifying nutritional content. A food group equivalent is equal to the
following:
------------------------------------------------------------------------
Food group
Food group equivalent Examples
------------------------------------------------------------------------
(i) Vegetable............... \1/2\ cup equivalent \1/2\ cup cooked
vegetable. green beans; 1 cup
raw spinach.
(ii) Fruit.................. \1/2\ cup equivalent \1/2\ cup
fruit. strawberries; \1/2\
cup 100% orange
juice; \1/4\ cup
raisins.
(iii) Grains................ No less than \3/4\ 1 slice of bread; \1/
oz equivalent whole 2\ cup cooked brown
grain. rice.
(iv) Dairy.................. \3/4\ cup equivalent 6 oz fat free
dairy. yogurt; 1\1/8\ oz
nonfat cheese.
(v) Protein foods........... 1\1/2\ oz equivalent 1\1/2\ oz venison.
game meat. 1 oz tuna.
1 oz equivalent 1 large egg.
seafood. \1/4\ cup black
1 oz equivalent egg. beans.
1 oz equivalent \1/2\ oz walnuts.
beans, peas, or soy
products.
1 oz equivalent nuts
and seeds.
------------------------------------------------------------------------
(3) You may use the term ``healthy'' or related terms (e.g.,
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,''
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as
an implied nutrient content claim on the label or in labeling of a food
that is useful in creating a diet that is consistent with dietary
recommendations if the food meets one or more of the criteria in
paragraphs (d)(3)(i) through (vi) of this section:
(i) A raw, whole fruit or vegetable.
(ii) An individual food that meets the following conditions per
reference amount customarily consumed per eating occasion (RACC):
----------------------------------------------------------------------------------------------------------------
The added sugars The sodium
It must contain at content must be content must be The saturated fat
If the food is . . . least . . . no greater than . no greater than . content must be no
. . . . greater than . . .
----------------------------------------------------------------------------------------------------------------
(A) A vegetable product........ 1/2 c-eq vegetable 0% DV 10% DV 5% DV.
(B) A fruit product............ 1/2 c-eq fruit.... 0% DV 10% DV 5% DV.
(C) A grain product............ \3/4\ oz 5% DV 10% DV 5% DV.
equivalent whole
grain.
(D) A dairy product............ \3/4\ cup 5% DV 10% DV 10% DV.
equivalent dairy.
(E) Protein Foods
(1) Game meats............. 1\1/2\ oz 0% DV 10% DV 10% DV.
equivalent.
(2) Seafood................ 1 oz equivalent... 0% DV 10% DV 10% DV.
(3) Egg.................... 1 oz equivalent... 0% DV 10% DV 10% DV.
(4) Beans, peas, and soy 1 oz equivalent... 0% DV 10% DV 5% DV.
products.
(5) Nuts and seeds......... 1 oz equivalent... 0% DV 10% DV 5% DV, excluding
saturated fat
derived from nuts
and seeds.
(F) Oils
[[Page 59201]]
(1) 100% Oil............... .................. 0% DV 0% DV 20% of total fat.
(2) Oil-based spreads whose .................. 0% DV 5% DV 20% of total fat.
fats come solely from oil.
(3) Oil-based dressing .................. 2% DV 5% DV 20% of total fat.
containing at least 30%
oil and oils meet the
requirements in paragraph
(d)(3)(ii)(F)(1) of this
section.
----------------------------------------------------------------------------------------------------------------
(iii) A mixed product that:
(A) Contains at least half a food group equivalent each of two
different food groups as specified in paragraph (d)(2) of this section;
and
(B) Meets the following conditions per RACC:
----------------------------------------------------------------------------------------------------------------
Excluding saturated fat content
The added sugars The sodium from nuts and seeds (if
If the mixed product contains at least . content must be content must be applicable), the saturated fat
. . no greater than . no greater than . content must be no greater than
. . . . . . .
----------------------------------------------------------------------------------------------------------------
(1) \1/2\ food group equivalent each of 0% DV 10% DV 5% DV; or 7\1/2\% DV if the
two of the following: fruit, vegetable, protein is a game meat,
and/or protein. seafood, or egg.
(2) \1/2\ food group equivalent of whole 2\1/2\% DV 10% DV 5% DV; or 7\1/2\% DV if the
grain and \1/2\ food group equivalent protein is a game meat,
of fruit, vegetable, or protein. seafood, or egg.
(3) \1/2\ food group equivalent of dairy 2\1/2\% DV 10% DV 7\1/2\% DV; or 10% DV if the
and \1/2\ food group equivalent of protein is a game meat,
fruit, vegetable, or protein. seafood, or egg.
(4) \1/2\ food group equivalent of dairy 5% DV 10% DV 7\1/2\% DV.
and \1/2\ food group equivalent of
whole grain.
----------------------------------------------------------------------------------------------------------------
(iv) A main dish product as defined in Sec. 101.13(m) that:
(A) Contains at least one full food group equivalent each of two
different food groups as specified in paragraph (d)(2) of this section;
and
(B) Meets the following conditions per labeled serving:
----------------------------------------------------------------------------------------------------------------
Excluding the saturated fat
The added sugars The sodium content from nuts and seeds (if
If the main dish product contains at content must be content must be applicable), the saturated fat
least . . . no greater than . no greater than . content must be no greater than
. . . . . . .
----------------------------------------------------------------------------------------------------------------
(1) A food group equivalent each of two 0% DV 20% DV 10% DV; or 15% DV if the protein
of the following: fruit, vegetable, and/ is a game meat, seafood, or
or protein. egg.
(2) A food group equivalent of whole 5% DV 20% DV 10% DV; or 15% DV if the protein
grain and a food group equivalent of is a game meat, seafood, or
fruit, vegetable, or protein. egg.
(3) A food group equivalent of dairy and 5% DV 20% DV 15% DV; or 20% DV if the protein
a food group equivalent of fruit, is a game meat, seafood, or
vegetable, or protein. egg.
(4) A food group equivalent of dairy and 10% DV 20% DV 15% DV.
a food group equivalent of whole grain.
----------------------------------------------------------------------------------------------------------------
(v) A meal product as defined in Sec. 101.13(l) that:
(A) Contains at least one full food group equivalent each of three
different food groups as specified in paragraph (d)(2) of this section;
and
(B) Meets the following conditions per labeled serving:
----------------------------------------------------------------------------------------------------------------
Excluding the saturated fat
The added sugars The sodium content from nuts and seeds (if
If the meal product contains at least . content must be content must be applicable), the saturated fat
. . no greater than . no greater than . content must be no greater than
. . . . . . .
----------------------------------------------------------------------------------------------------------------
(1) A food group equivalent each of 0% DV 30% DV 15% DV; or 20% DV if the protein
fruits, vegetables, and protein foods. is a game meat, seafood, or
egg.
(2) A food group equivalent of whole 5% DV 30% DV 15% DV; or 20% DV if the protein
grain and a food group equivalent each is a game meat, seafood, or
of fruit, vegetable, and/or protein. egg.
[[Page 59202]]
(3) A food group equivalent of dairy and 5% DV 30% DV 20% DV; or 25% DV if the protein
a food group equivalent each of fruit, is a game meat, seafood, or
vegetable, and/or protein. egg.
(4) A food group equivalent of dairy, a 10% DV 30% DV 20% DV; or 25% DV if the protein
food group equivalent of whole grain, is a game meat, seafood, or
and a food group equivalent of fruit, egg.
vegetable, and/or protein.
----------------------------------------------------------------------------------------------------------------
(vi) Plain water and plain carbonated water without any flavoring
or additional ingredients.
(4) Each manufacturer of a food (other than raw, whole fruits, raw
whole vegetables, water, and individual foods where the standard
information required on the food label, such as the list of
ingredients, provides sufficient information to verify that the food
meets the food group equivalent requirements to bear the claim) that
bears the implied nutrient content claim ``healthy'' must make and keep
written records (e.g., analyses of databases, recipes, formulations,
information from recipes or formulations, or batch records) to verify
that the food meets the food group equivalent requirements of paragraph
(d)(2) of this section where the food group equivalent contained in the
product is not apparent from the label of the food. These records must
be kept for a period of at least 2 years after introduction or delivery
for introduction of the food into interstate commerce. Such records
must be provided to FDA upon request, during an inspection, for
official review and photocopying or other means of reproduction.
Records may be kept either as original records, true copies (such as
photocopies, pictures, scanned copies, microfilm, microfiche, or other
accurate reproductions of the original records), or electronic records
which must be kept in accordance with part 11 of this chapter. These
records must be accurate, indelible, and legible.
Dated: September 22, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-20975 Filed 9-28-22; 8:45 am]
BILLING CODE 4164-01-P