Federal Register, Volume 90 Issue 135 (Thursday, July 17, 2025)

[Federal Register Volume 90, Number 135 (Thursday, July 17, 2025)]
[Proposed Rules]
[Pages 33346-33349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13423]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 145 and 155

[Docket No. FDA-2025-N-1184]
RIN 0910-AJ06

Revocation of Food Standards for 11 Products Not Currently Sold

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
revoke 11 food standards for foods that are no longer sold in the
United States. FDA is taking this action as we tentatively conclude
these standards are no longer necessary to promote honesty and fair
dealing in the interest of consumers. This action, if finalized, will
remove obsolete rules to possibly reduce unnecessary regulatory
requirements.

DATES: Either electronic or written comments on the proposed rule or
its companion direct final rule must be submitted by August 18, 2025.
If FDA receives any timely significant adverse comments on the direct
final rule with which this proposed rule is associated, we will publish
a document withdrawing the direct final rule within 30 days after the
comment period ends, and we will then proceed to respond to comments
under this proposed rule using the usual notice and comment procedures.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 18, 2025. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 18, 2025. 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-2025-N-1184 for ``Revocation of Food Standards for 11 Products Not
Currently Sold.'' 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.

FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Office of
Nutrition and Food Labeling, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371;
Meadow Platt, Office of Policy, Regulations, and Information, Human
Foods Program, Food and Drug Administration, 5001 Campus Dr., College
Park, MD 20740, 240-402-2378.

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
D. Costs and Benefits

[[Page 33347]]

II. Background
III. Description of the Proposed Rule
IV. Economic Analysis of Impacts
A. Introduction
B. Overview of Benefits, Costs, and Transfers
V. Analysis of Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. Consultation and Coordination With Indian Tribal Governments

I. Executive Summary

A. Purpose of the Proposed Rule

This action proposes to remove regulations that FDA believes are
obsolete and no longer necessary to promote honesty and fair dealing in
the interest of consumers. This proposed rule is a companion to the
direct final rule published elsewhere in this issue of the Federal
Register. This companion proposed rule provides the procedural
framework to finalize the rule in the event the direct final rule
receives any significant adverse comment and is withdrawn. The comment
period for this companion proposed rule runs concurrently with the
comment period for the direct final rule. Any comments received in
response to this companion proposed rule will also be considered as
comments regarding the direct final rule.

B. Summary of the Major Provisions of the Proposed Rule

This proposed rule would revoke:
Part 145--Canned Fruits
145.116: Artificially sweetened canned apricots
145.126: Artificially sweetened canned cherries
145.131: Artificially sweetened canned figs
145.134: Canned preserved figs
145.136: Artificially sweetened canned fruit cocktail
145.140: Canned seedless grapes
145.171: Artificially sweetened canned peaches
145.176: Artificially sweetened canned pears
145.181: Artificially sweetened canned pineapple

The proposed revocation of the standards for artificially sweetened
canned fruit applies only to canned fruit made with saccharin and/or
sodium saccharin since these are the only products covered under the
standard. The proposed revocation does not apply to any other reduced
sugar canned fruit products.
Part 155--Canned Vegetables
155.131: Canned field corn
155.172: Canned dry peas

C. Legal Authority

We are issuing this proposed rule to revoke the standards for the
listed products based on our authority under section 401 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 341), which
directs the Secretary of Health and Human Services (Secretary) to issue
regulations fixing and establishing for any food a reasonable
definition and standard of identity, quality, or fill of container
whenever, in the Secretary's judgment, such action will promote honesty
and fair dealing in the interest of consumers. This proposed rule is
also issued upon the Secretary's authority under section 701(a) of the
FD&C Act (21 U.S.C. 371) for the efficient enforcement of the FD&C Act.

D. Costs and Benefits

Our analysis of the current market indicates that there are no
products currently marketed under the standards of identity listed
above. Therefore, we tentatively conclude that the proposed rule to
revoke the standards would result in zero benefits and zero costs to
consumers and industry.

II. Background

President Trump has directed the heads of executive departments and
agencies to eliminate unnecessary and burdensome regulations.
(Executive Order 14192, Unleashing Prosperity Through Deregulation (90
FR 9065, February 6, 2025; signed January 31, 2025)). Independently,
Secretary Kennedy has expressed support for deregulatory initiatives
across all HHS components to focus on the core mission to Make America
Healthy Again. See Request for Information (RFI): Ensuring Lawful
Regulation and Unleashing Innovation to Make America Healthy Again (90
FR 20478, May 14, 2025). Addressing these 11 standards for foods no
longer marketed in the U.S is consistent with these directives. It is
also consistent with section 6 of Executive Order 13563, ``Improving
Regulation and Regulatory Review'' (76 FR 3821, January 21, 2011),
which requires agencies to periodically conduct retrospective analyses
of existing regulations to identify those ``that might be outmoded,
ineffective, insufficient, or excessively burdensome, and to modify,
streamline, expand, or repeal them'' accordingly.
Section 401 of the FD&C Act (21 U.S.C. 341) directs the Secretary
to issue regulations fixing and establishing for any food a reasonable
definition and standard of identity, quality, or fill (standards) of
container whenever, in the Secretary's judgment, such action will
promote honesty and fair dealing in the interest of consumers. FDA has
initially identified 11 standards for foods that are no longer sold. As
such, we tentatively conclude that these standards are no longer
necessary to promote honesty and fair dealing in the interest of
consumers. Therefore, FDA proposes to revoke those 11 standards.

III. Description of the Proposed Rule

FDA is proposing to revoke 11 food standards because FDA is not
aware of evidence that such foods are currently being sold in the U.S.
To assess the U.S. market for these foods, FDA reviewed supermarket
scanner data on consumer purchases, as well as data from commercial
databases for food products, and conducted internet searches.\1\ This
data displayed no purchases for 11 standardized foods that are the
subject of this proposed rule. As such, FDA is not aware of any
evidence indicating that these standards ``promote honesty and fair
dealing in the interest of consumers.'' See 21 U.S.C. 341. Therefore,
we tentatively conclude that such regulations are no longer necessary.
Moreover, we note that should anyone wish to manufacture and distribute
one of the listed products in the United States in the future they may
do so under the provisions of the FD&C Act and implementing regulations
that apply to nonstandardized foods or foods in general.\2\
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\1\ Mintel is a commercial database of retail food products that
we searched to evaluate if the identified food standards are
currently on the market. The advanced search tool was used to limit
results with the following parameters: product name, food product
category, and region where sold (U.S.). If necessary for the
product, the search was also narrowed by food ingredients, food
characteristics, and year. Recent sales data was also considered
using the information from an additional market research company. We
note these databases do not capture online sales. We performed
internet searches and did not find evidence of online sales.
\2\ We are aware that other kinds of reduced sugar canned fruits
other than those sweetened with saccharin are on the market,
including those sweetened with fruit juice, light syrup, other non-
nutritive sweeteners, or a combination of these. However, because
these products are not sweetened with saccharin, they are not
covered under the standards being revoked. We note that if, in the
future, manufacturers produce the artificially sweetened fruits in
the standards revoked in this rulemaking, such foods would appear to
be covered under 21 CFR 130.10, provided that the corresponding
standard for the non-artificially sweetened version (i.e., canned
apricots, canned cherries, canned figs, canned fruit cocktail,
canned peaches, canned pears, canned pineapple) remains
standardized.
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In the event of a stay or invalidation of any of the standards
identified for removal, the remaining standards identified in this rule
would be unaffected.

[[Page 33348]]

IV. Economic Analysis of Impacts

A. Introduction

We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 14192, 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 benefits,
costs, and transfers of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 14192 requires that any new incremental
costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least ten prior regulations.'' Rules are
``economically significant'' under Executive Order 12866 Section
3(f)(1) if they ``have an annual effect on the economy of $100 million
or more; or adversely affect in a material way the economy, a sector of
the economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities.'' The Office of Information and Regulatory Affairs (OIRA)
has determined that this proposed rule is not a significant regulatory
action under 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 we conclude that this prosed rule would not generate
compliance costs, we proposed to certify that the proposed rule will
not have a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes estimates of
anticipated impacts, before 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 $187
million, using the most current (2024) Implicit Price Deflator for the
Gross Domestic Product. This proposed would not result in an
expenditure in any year that meets or exceeds this amount.

B. Overview of Benefits, Costs, and Transfers

The proposed rule would revoke 11 food standards for products not
currently sold. Since no firms are producing these products, we do not
anticipate any manufacturers to change their practice. Therefore, we do
not anticipate any costs associated with this proposed rule. If a firm
were to choose to start producing one of these products again, there
could be benefits in terms of additional flexibility. We do not
anticipate that any firms would reenter the market and therefore do not
anticipate any benefits of this rule.

Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
[millions of 2024 dollars]
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Units
Primary Low High ------------------------------------
Category estimate estimate estimate Year Discount Period Notes
dollars rate (%) covered
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Benefits:
Annualized..................................................... $0 $0 $0 2024 7 .......... ...........
Monetized ($millions/year)..................................... .......... .......... .......... .......... 3 .......... ...........
Annualized..................................................... .......... .......... .......... .......... 7 .......... ...........
Quantified..................................................... .......... .......... .......... .......... 3 .......... ...........
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Qualitative....................................................
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Costs:
Annualized..................................................... 0 0 0 2024 7 .......... ...........
Monetized ($millions/year)..................................... .......... .......... .......... .......... 3 .......... ...........
Annualized..................................................... .......... .......... .......... .......... 7 .......... ...........
Quantified..................................................... .......... .......... .......... .......... 3 .......... ...........
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Qualitative....................................................
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Transfers:
Federal........................................................ .......... .......... .......... .......... 7 .......... ...........
Annualized..................................................... .......... .......... .......... .......... 3 .......... ...........
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Monetized ($millions/year).................................... From:
To: ..........
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Other.......................................................... .......... .......... .......... .......... 7 .......... ...........
Annualized..................................................... .......... .......... .......... .......... 3 .......... ...........
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Monetized ($millions/year).................................... From:
To: ..........
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Effects:
State, Local or Tribal Government: None
Small Business: None...........................................
Wages: None....................................................
Growth: None...................................................
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Note: Benefits encompass positive and negative benefits. Costs encompass costs and cost savings.

In line with Executive Order 14192, in Table 2 we estimate present
and annualized values of costs, cost savings, and net costs over a
perpetual time horizon. This proposed rule, if finalized as proposed,
is expected to be deregulatory under E.O. 14192.

[[Page 33349]]

Table 2--E.O. 14192 Summary Table
[in millions of 2024 dollars, discounted over an infinite time horizon
at a 7 percent discount rate]
------------------------------------------------------------------------
Primary Low High
estimate estimate estimate
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Present Value of Costs........... $0 ........... ...........
Present Value of Cost Savings.... 0 ........... ...........
Present Value of Net Costs....... 0 ........... ...........
Annualized Costs................. 0 ........... ...........
Annualized Cost Savings.......... 0 ........... ...........
Annualized Net Costs............. 0 ........... ...........
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Note: Values in parentheses denote net negative costs (i.e. net cost
savings).

We have developed a Preliminary Economic Analysis of Impacts that
assesses the impacts of the proposed rule. The full analysis of
economic impacts is available in the docket for this proposed rule at
https://www.fda.gov/economics-staff/regulatory-impact-analyses-ria.

V. Analysis of Environmental Impact

We have tentatively determined under 21 CFR part 25.32(a) 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.

VI. Paperwork Reduction Act of 1995

FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

VII. Federalism

We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have tentatively
determined that this proposed rule does not contain policies that have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Accordingly, we conclude that the proposed rule does not contain
policies that have federalism implications as defined in the Executive
Order and, consequently, a federalism summary impact statement is not
required.

VIII. 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 proposed 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 invite comments from tribal officials
on any potential impact on Indian Tribes from this proposed action.

List of Subjects

21 CFR Part 145

Food grades and standards, Canned fruits.

21 CFR Part 155

Food grades and standards, Canned vegetables.

Therefore, under the Federal Food, Drug, and Cosmetic Act, we
propose to amend 21 CFR parts 145 and 155 as follows:

PART 145--CANNED FRUITS

0
1. The authority citation for part 145 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

Sec. Sec. 145.116, 145.126, 145.131, 145.134, 145.136, 145.140,
145.171, 145.176, and 145.181 [Removed]

0
2. Sections 145.116, 145.126, 145.131, 145.134, 145.136, 145.140,
145.171, 145.176, and 145.181 are removed.

PART 155--CANNED VEGETABLES

0
3. The authority citation for part 155 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

Sec. Sec. 155.131 and 155.172 [Removed]

0
4. Sections 155.131 and 155.172 are removed.

Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-13423 Filed 7-16-25; 8:45 am]
BILLING CODE 4164-01-P