In a final rule published in a Federal Register Notice (FRN) on September 25, 2025, the Food and Drug Administration (FDA) announced a new requirement that prior notice be submitted within 10 days from the notice of refusal, issued entry hold, or requested response from an FDA review was issued.
In addition, this final rule also establishes a 30-calendar day submission requirement for food facility registrations (FFR) for shipments that are held due to an unregistered facility.
This final rule will go into effect on October 27, 2025.
FRN 2025-18655 can be found here:
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
