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Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions

The Food and Drug Administration published this final rule in the Federal Register on September 25, 2025. It took effect on October 27, 2025.

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What the agency says

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its prior notice regulation to add a requirement that prior notice and food facility registration information be submitted within a certain timeframe after certain notices of refusal or hold have been issued ("post-refusal" and "post-hold" submission) or responses to requests for FDA review have been issued and beginning October 1, 2026, add a requirement that the prior notice for articles of food arriving by international mail include the name of the mail service and a mail tracking number. The rule will also finalize certain technical changes, including those that reflect expanded capabilities of the Automated Broker Interface/Automated Commercial Environment/International Trade Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface (PNSI). These amendments will improve program efficiency and better enable FDA to protect the U.S. food supply and public health.

Key facts

Document number
2025-18655
Type
Final rule
Action
Final rule
Agency
Health and Human Services Department; Food and Drug Administration
Published
September 25, 2025
Takes effect
October 27, 2025
Dates
This rule is effective October 27, 2025.
Docket
Docket No. FDA-2011-N-0179
Regulation ID (RIN)
0910-AI75
Code of Federal Regulations
21 CFR 1
Topics
Cosmetics; Drugs; Exports; Food labeling; Imports; Labeling; Reporting and recordkeeping requirements
Pages
12

The document on federalregister.gov PDF

Other documents from the Food and Drug Administration

Everything from the Food and Drug Administration · Rules on cosmetics · Rules on drugs · Rules on exports · Published in September 2025

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.