[Federal Register Volume 90, Number 135 (Thursday, July 17, 2025)]
[Rules and Regulations]
[Pages 33268-33272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13421]
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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: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA or we) revokes 11 food
standards for foods that are no longer sold in the United States. FDA
is taking this action as these standards are no longer necessary to
promote honesty and fair dealing in the interest of consumers. This
action will remove obsolete rules to reduce unnecessary regulatory
requirements.
DATES: This rule is effective September 22, 2025, unless significant
adverse comment is received by August 18, 2025. If FDA receives
significant adverse comments, it will publish a timely withdrawal in
the Federal Register informing the public that this rule or a portion
thereof will not take effect.
ADDRESSES: You may submit comments as follows. Please note that late,
[[Page 33269]]
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 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 Direct Final Rule
B. Summary of the Major Provisions of the Direct Final Rule
C. Legal Authority
D. Costs and Benefits
II. Background
III. Description of the Direct Final 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 Direct Final Rule
This action removes regulations that FDA believes are obsolete and
no longer necessary to promote honesty and fair dealing in the interest
of consumers. We are also publishing elsewhere in this issue of the
Federal Register a companion proposed rule proposing to take the
actions described in this direct final rule. The companion proposed
rule provides a procedural framework within which the rule may be
finalized if the direct final rule is withdrawn because of any
significant adverse comments. The comment period for the direct final
rule runs concurrently with the companion proposed rule. Any comments
received in response to the companion proposed rule will be considered
as comments regarding the direct final rule.
B. Summary of the Major Provisions of the Direct Final Rule
This direct final rule revokes:
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 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 these
standards. The 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
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C. Legal Authority
We are issuing this direct final 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 direct final 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 conclude that the direct final 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). Revoking 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 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,
these standards are no longer necessary to promote honesty and fair
dealing in the interest of consumers. Therefore, in this direct final
rule, FDA revokes those 11 standards.
III. Description of the Direct Final Rule
FDA is revoking 11 food standards because FDA is aware of no
evidence that such foods are currently being sold in the United States.
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 the 11 standardized foods that are the
subject of this direct final 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,
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 foods 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 therefore further performed internet
searches using product names and also 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. In addition, if a significant adverse comment
applies to a part of the direct final rule and that part can be severed
from the remainder of the rule, we may adopt as final those provisions
of the rule that are not the subject of the significant adverse
comment.
IV. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14192, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104-121), 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 final rule is not a significant regulatory
action under Executive Order 12866.
Because this rule is not likely to result in an annual effect on
the economy of $100 million or more or to meet other criteria specified
in the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does not fall within
the scope of 5 U.S.C. 804(2).
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 final rule would not generate
compliance costs, we certify that the final 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,
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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 final rule will not result in an
expenditure in any year that meets or exceeds this amount.
B. Overview of Benefits, Costs, and Transfers
The final rule will 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 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 expect any firms
to reenter the market and therefore do not anticipate any benefits of
this rule.
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Final Rule
[Millions of 2024 dollars]
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Units
Primary Low High ----------------------------------------
Category estimate estimate estimate Year Discount rate Period Notes
dollars (%) covered
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Benefits:
Annualized............................... $0 $0 $0 2024 7
Monetized ($millions/year)............... .......... .......... .......... .......... 3
Annualized............................... .......... .......... .......... .......... 7
Quantified............................... .......... .......... .......... .......... 3
Qualitative
Costs:
Annualized............................... 0 0 0 2024 7
Monetized ($millions/year)............... .......... .......... .......... .......... 3
Annualized............................... .......... .......... .......... .......... 7
Quantified............................... .......... .......... .......... .......... 3
Qualitative
Transfers:
Federal.................................. .......... .......... .......... .......... 7
Annualized............................... .......... .......... .......... .......... 3
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Monetized ($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 final rule is considered deregulatory
under E.O. 14192. Details on the estimated cost savings of this rule
can be found in the rule's economic analysis.
Table 2--Executive Order 14192 Summary Table
[In millions of 2024 dollars, discounted over an infinite time horizon at a 7 percent discount rate]
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Primary
estimate Low estimate High 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 an Economic Analysis of Impacts that assesses the
impacts of the final rule. The full analysis of economic impacts is
available in the docket for this direct final rule at https://www.fda.gov/economics-staff/regulatory-impact-analyses-ria.
V. Analysis of Environmental Impact
We have determined under 21 CFR 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 concludes that this direct final rule contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under
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the Paperwork Reduction Act of 1995 is not required.
VII. Federalism
We have analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this direct final 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 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 direct final 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 invite comments from tribal officials
on any potential impact on Indian Tribes from this direct final action.
List of Subjects
21 CFR Part 145
Canned fruits, Food grades and standards.
21 CFR Part 155
Canned vegetables, Food grades and standards.
Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR
parts 145 and 155 are amended 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. 2025-13421 Filed 7-16-25; 8:45 am]
BILLING CODE 4164-01-P