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

Document 2025-18655 is a Final Rule published by the Department of Health and Human Services in the Federal Register on September 25, 2025, with an effective date of October 27, 2025. 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. View the original at https://www.federalregister.gov/documents/2025/09/25/2025-18655/prior-notice-adding-requirement-to-submit-mail-tracking-number-for-articles-of-food-arriving-by.

No. Document 2025-18655 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.