What Happens Without FDA Prior Notice?

Food imported without adequate, timely Prior Notice is subject to refusal and must be held at the port or a secure facility until it is resolved (21 CFR 1.283). International mail without a PN number can be held 72 hours and returned or destroyed. Food from an unregistered facility is held under 21 U.S.C. 381(l).

What to do

• File (or correct) Prior Notice and ask the carrier or broker how to request release
• Keep storage costs in mind; the owner pays them
• For repeated problems, review your process before the next shipment

How we help

• We draft a new or corrected Prior Notice for your approval
• For serious holds, our network of former FDA professionals is available as regulatory incident support

Related: FDA renewal deadline calendar · Do I need a U.S. Agent? · US Agent Desk pricing

General information, not legal advice. Last reviewed October 21, 2026.