2024-31419. Uniform Compliance Date for Food Labeling Regulations

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Department of Health and Human Services

Food and Drug Administration

1. 21 CFR Part 101
2. [Docket No. FDA-2000-N-0011]

AGENCY:

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

ACTION:

Final action; announcement of a uniform compliance date.

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.” ( print 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 onhttps://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 ( print 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.