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FDA Finalizes Amendments to Prior Notice Requirements for Imported Food Shipments
Monday, September 29, 2025
  • On September 25, 2025, the U.S. Food and Drug Administration (FDA) finalized amendments to its regulation governing prior notice requirements for imported human and animal food. These changes aim to enhance the agency’s ability to identify and inspect food shipments that may pose risks to public health, particularly those arriving via international mail.
  • Under the new rule, prior notice submissions must now include the name of the mail service and a mail tracking number for food articles sent through international mail. This information will enable FDA to better coordinate with the U.S. Postal Service, Customs and Border Protection, and other agencies to track and inspect potentially hazardous shipments, including those flagged as bioterrorism risks.
  • Additionally, the rule introduces a new requirement for timely submission of prior notice and food facility registration information when a shipment has been refused or placed on hold. By establishing a timeframe for these “post-refusal” and “post-hold” submissions, FDA aims to reduce delays at ports of entry and minimize associated costs.
  • The final rule is part of Docket No. FDA-2011-N-0179 and builds on earlier proposals to strengthen oversight of food imports, particularly those entering the country through less traditional channels like international mail.
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