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FDA releases Guidance on Prior Notice of Imported Food Q&A (Ed. 4)


Oct 19, 2023

The U.S. Food and Drug Administration (FDA) has issued with Notice 2023-22649 a final guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry.”

The main upadtes in the guidance relate to:

  • Clarify that even if the FDA has determined that the regulatory system of the country of origin of imported food is equivalent to that of the United States, it does not exempt food produced in that country from the requirement of prior notice when imported into the United States;
  • Clarify that if the FDA makes a conclusion on the refusal of entry or detention for inspection of the imported food notified in advance, the importer may, within 5 natural days of receiving the conclusion, request the FDA to review it again.

For further information (in English), click on the Link

Check the full text of the document (in English), click on the Link

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