Rule2025-03118
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
Primary source
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Published
February 25, 2025
Effective
April 28, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule entitled "Food Labeling: Nutrient Content Claims; Definition of Term `Healthy,' " is delayed until April 28, 2025.
Full Text
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<title>Federal Register, Volume 90 Issue 36 (Tuesday, February 25, 2025)</title>
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[Federal Register Volume 90, Number 36 (Tuesday, February 25, 2025)]
[Rules and Regulations]
[Pages 10592-10593]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-03118]
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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: Final rule; delay of effective date.
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SUMMARY: In accordance with the memorandum of January 20, 2025, from
the President, entitled ``Regulatory Freeze Pending Review,'' the
effective date of the final rule entitled ``Food Labeling: Nutrient
Content Claims; Definition of Term `Healthy,' '' is delayed until April
28, 2025.
DATES: As of February 25, 2025, the effective date for the final rule
published December 27, 2024 (89 FR 106064), is delayed until April 28,
2025.
FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Office of Nutrition
and Food Labeling Human Foods Program, Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-1450; Denise See or
Barbara Little, Office of Policy, Regulations, and Information (HFS-
024), Human Foods Program, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Electronic Access and Filing
A copy of the notice of proposed rulemaking (87 FR 59168, September
29, 2022), all comments received, the final rule (89 FR 106064,
December 27, 2024), and all background material may be viewed online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> using the docket number listed above. A
copy of this document will be placed in the docket. Electronic
retrieval help and guidelines are available on the website. It is
available 24 hours each day, 365 days each year. An electronic copy of
this document may also be downloaded from the Office of the Federal
Register's website at <a href="https://www.federalregister.gov">https://www.federalregister.gov</a> and the
Government Publishing Office's website at <a href="https://www.gpo.gov">https://www.gpo.gov</a>.
II. Background
FDA published a final rule, entitled ``Food Labeling: Nutrient
Content Claims; Definition of Term `Healthy,' ''
[[Page 10593]]
in the Federal Register on December 27, 2024 (89 FR 106064). The final
rule was published with an effective date of February 25, 2025. On
January 20, 2025, the President issued a memorandum entitled
``Regulatory Freeze Pending Review'' (90 FR 8249 (January 28, 2025)).
With respect to rules that have been published in the Federal Register,
but have not taken effect, the memorandum orders Agencies to consider
postponing the rules' effective dates for 60 days (i.e., until April
28, 2025) for the purpose of reviewing any questions of fact, law, and
policy the rules may raise.
In accordance with this direction, FDA is delaying the effective
date of the final rule ``Food Labeling: Nutrient Content Claims;
Definition of Term `Healthy' '' (89 FR 106064), until April 28, 2025.
We note that the compliance date remains unchanged at this time. The
final rule:
<bullet> updates the requirements for when the term ``healthy'' can
be used as an implied nutrient content claim in the labeling of human
food products to help consumers identify foods that can serve as the
foundation of a nutritious diet that is consistent with current dietary
recommendations;
<bullet> establishes parameters for use of the term ``healthy'' or
derivative terms ``health,'' ``healthful,'' ``healthfully,''
``healthfulness,'' ``healthier,'' ``healthiest,'' ``healthily,'' and
``healthiness'' as an implied nutrient content claim on the label or in
labeling of a food that suggests that a food, because of its nutrient
content, may help consumers maintain healthy dietary practices, where
there is also implied or explicit information about the nutrition
content of the food on the label or in the labeling;
<bullet> establishes a framework based on food groups and nutrients
to limit (NTL) for the ``healthy'' claim;
<bullet> establishes that ``food group,'' for the purposes of the
``healthy'' claim, refers to the groups of foods recommended in the
Dietary Guidelines, 2020-2025 (for adults and children 2 years of age
and older; available at <a href="https://www.dietaryguidelines.gov">https://www.dietaryguidelines.gov</a>), which are
vegetables, fruits, dairy, grains, protein foods, as well as oils;
<bullet> establishes food group equivalents (FGEs) that identify
qualifying amounts of foods from each food group based on nutritional
content;
<bullet> requires that, to bear a claim subject to the rule,
individual food products, mixed products, main dishes, and meals must
meet FGEs and specific limits for added sugars, saturated fat, and
sodium based on a percentage of the Daily Value for these nutrients;
<bullet> provides that individual foods or mixed products that are
comprised of one or more of the following foods encouraged by the
Dietary Guidelines, 2020-2025, with no other added ingredients except
for water: vegetable; fruit; whole grains; fat-free and low-fat dairy;
lean meat, seafood, eggs, beans, peas, lentils, nuts and seeds,
automatically qualify (i.e., without having to meet the FGE and NTL
requirements) for the ``healthy'' claim because of their nutrient
profile and positive contribution to an overall healthy diet;
<bullet> provides that all water, tea, and coffee with less than 5
calories per reference amount customarily consumed and per labeled
serving automatically qualify for the ``healthy'' claim; and
<bullet> requires the establishment and maintenance of certain
records for foods bearing the ``healthy'' claim where the FGE contained
in the product is not apparent from the label of the food. The records
must be kept for a period of at least 2 years after introduction or
delivery for introduction of the food into interstate commerce. During
an inspection, such records must be provided to FDA upon request for
official review and photocopying or other means of reproduction.
To the extent that 5 U.S.C. 553 applies to this action, it is
exempt from notice and comment because it constitutes a rule of
procedure under 5 U.S.C. 553(b)(A). Alternatively, FDA's implementation
of this action without opportunity for public comment, effective
immediately, is based on the good cause exceptions in 5 U.S.C.
553(b)(B) and (d)(3). Seeking public comment is impracticable,
unnecessary, and contrary to the public interest. The temporary delay
in the effective date until April 28, 2025, is necessary to give Agency
officials the opportunity for further review and consideration of the
new regulation, consistent with the memorandum described previously.
Seeking public comment is unnecessary because of the limited impact of
the delayed effective date; the compliance date, and not the effective
date, controls when parties must comply with this rule, and the
compliance date in the final rule is not until 2028. FDA also stated in
the final rule that parties are free to begin implementing the rule
earlier than the compliance date. In addition, given the imminence of
the effective date and the brief length of the extension of the
effective date, seeking prior public comment on this temporary delay
would have been impracticable, as well as contrary to the public
interest in the orderly promulgation and implementation of regulations.
FDA also recognizes that certain affected entities would benefit from
being informed as soon as possible of the extension and its length in
order to plan and adjust their implementation process accordingly.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-03118 Filed 2-24-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on February 25, 2025.
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