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[Federal Register Volume 89, Number 250 (Tuesday, December 31, 2024)]
[Rules and Regulations]
[Pages 106996-106998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31419]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2000-N-0011]

Uniform Compliance Date for Food Labeling Regulations

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final action; announcement of a uniform compliance date.

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SUMMARY: The Food and Drug Administration (FDA or we) is establishing 
January 1, 2028, as the uniform compliance date for food labeling 
regulations that are published on or after January 1, 2025, and on or 
before December 31, 2026. We periodically announce uniform compliance 
dates for new food labeling requirements to minimize the economic 
impact of labeling changes.

DATES: This final action is effective December 31, 2024. Either 
electronic or written comments on the final action must be submitted by 
March 3, 2025.

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 March 3, 2025. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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.''

[[Page 106997]]

    Instructions: All submissions received must include the Docket No. 
FDA-2000-N-0011 for ``Uniform Compliance Date for Food Labeling 
Regulations.'' 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: Lauren Kleinman, Human Foods Program 
(HFS-24), Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    We periodically issue regulations requiring changes in the labeling 
of food. If the compliance dates of these labeling changes were not 
coordinated, the cumulative economic impact on the food industry of 
having to respond separately to each change would be substantial. 
Therefore, we periodically have announced uniform compliance dates for 
new food labeling requirements (see, e.g., the Federal Register of 
October 19, 1984 (49 FR 41019); December 24, 1996 (61 FR 67710); 
December 27, 1996 (61 FR 68145); December 23, 1998 (63 FR 71015); 
November 20, 2000 (65 FR 69666); December 31, 2002 (67 FR 79851); 
December 21, 2006 (71 FR 76599); December 8, 2008 (73 FR 74349); 
December 15, 2010 (75 FR 78155); November 28, 2012 (77 FR 70885); 
December 10, 2014 (79 FR 73201); November 25, 2016 (81 FR 85156); 
December 20, 2018 (83 FR 65294); January 6, 2021 (86 FR 462); and 
January 3, 2023 (88 FR 6)). Use of a uniform compliance date provides 
for an orderly and economical industry adjustment to new labeling 
requirements by allowing sufficient lead time to plan for the use of 
existing label inventories and the development of new labeling 
materials.

II. 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.

III. Paperwork Reduction Act of 1995

    This final action contains no collections of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required.

IV. Conclusion

    This action does not relate to existing requirements for compliance 
dates contained in final rules published before January 1, 2025. 
Therefore, the compliance dates for all final rules published by FDA in 
the Federal Register before January 1, 2025, will be the date stated in 
the respective final rule. We generally encourage industry to comply 
with new labeling regulations as quickly as feasible, however. Thus, 
when industry members voluntarily change their labels, it is 
appropriate that they incorporate any new requirements that have been 
published as final regulations up to that time.
    In rulemaking that began with publication of a proposed rule on 
April 15, 1996 (61 FR 16422), and ended with a final rule on December 
24, 1996 (61 FR 67710) (together ``the 1996 rulemaking''), we provided 
notice and an opportunity for comment on the practice of establishing 
uniform compliance dates by issuance of a final rule announcing the 
date. We received no comments objecting to this practice during the 
1996 rulemaking, nor have we received comments objecting to this 
practice since we last published a uniform compliance date final rule 
on January 3, 2023 (88 FR 6).
    We find for good cause that notice and public procedure thereon are 
unnecessary because this action is uncontroversial and is consistent 
with FDA's past practice over many years. In this proceeding, FDA has 
identified a uniform compliance date that is approximately 3 years 
after the date of publication of this final action, consistent with 
past uniform compliance date rules. Moreover, interested parties will 
have an opportunity to comment on the compliance date for each 
individual food labeling regulation as part of the rulemaking process 
for that regulation. Consequently, FDA finds that notice and public 
procedure thereon are unnecessary for this final action. However, under 
21 CFR 10.40(e)(1), we are providing an opportunity for comment on 
whether the uniform compliance date established by this final action 
should be modified or revoked.
    In addition, we find good cause for this final action to become 
effective on the date of publication of this action. A delayed 
effective date is unnecessary in this case because this action does not 
impose any new regulatory requirements on affected parties. Instead, 
this final action provides affected parties with notice of our intent 
to identify January 1, 2028, as the compliance date for final food 
labeling regulations that require changes in the labeling of food 
products and that publish on or after January 1, 2025, and on or before 
December 31, 2026, unless special circumstances justify a different 
compliance date. Thus, affected parties do not need time to prepare 
before the rule takes effect. Therefore, we find good cause for this 
final action to become effective on the date of publication of this 
action.
    The uniform compliance date is only relevant to final FDA food 
labeling regulations that require changes in the labeling of food 
products and that publish on or after January 1, 2025, and on or before 
December 31, 2026. All

[[Page 106998]]

food products subject to the January 1, 2028, compliance date must 
comply with the appropriate regulations when initially introduced into 
interstate commerce on or after January 1, 2028. If any food labeling 
regulation involves special circumstances that justify a compliance 
date other than January 1, 2028, we will determine for that regulation 
an appropriate compliance date, which will be specified when the final 
regulation is published.

    Dated: December 26, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31419 Filed 12-30-24; 8:45 am]
BILLING CODE 4164-01-P
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