FDA Prior Notice FAQs
What is FDA Prior Notice for food imports? +
FDA Prior Notice is a mandatory electronic notification required under the Bioterrorism Act of 2002 (21 CFR Part 1, Subpart I). It must be submitted to the FDA before any food shipment arrives in the United States, notifying the FDA of the article of food, its manufacturer, shipper, and expected arrival details.
How far in advance must FDA Prior Notice be submitted? +
Advance notice requirements: 2 hours before arrival for land (truck/rail) shipments; 4 hours for air cargo; and 8 hours for ocean vessel shipments. Submission must be through FDA's PNSI (Prior Notice System Interface) or via ACE (Automated Commercial Environment).
What information is required in an FDA Prior Notice? +
Required fields include: article of food description, FDA product code, quantity and lot numbers, manufacturer name and address, shipper name and address, importer of record, country of origin, anticipated port of entry, and estimated arrival date and time. Missing any required field can cause the submission to be rejected by FDA's PNSI system.
What is the FDA product code and how do I find it? +
The FDA product code is a 7-digit alphanumeric identifier that classifies the type of food. You can search for the correct code using FDA's Product Code Builder tool on the FDA website. Using the wrong product code is a common error that can result in shipment holds, so verify it carefully against the actual product type.
What happens if FDA Prior Notice is not filed? +
Failure to file a Prior Notice — or filing an inaccurate one — can result in the food shipment being refused entry into the United States. FDA has the authority to hold and refuse admission of any food that lacks a valid Prior Notice. The importer is responsible for all storage and handling costs during any hold, and the food may ultimately be destroyed or re-exported.