Prior Notice is the advance notification required by the Food and Drug Administration for nearly all food imported into the United States, including food for humans and animals. The requirement was established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and implemented under 21 CFR Part 1, Subpart I.
The purpose is to give FDA time to review incoming food shipments and target inspections of shipments that may pose a public health risk.
Prior Notice filing requirements:
- Must be submitted before the food arrives at the U.S. port of entry
- Minimum advance times: 2 hours by land, 4 hours by air or rail, 8 hours by water
- Maximum advance time: no more than 30 days before arrival (15 days for mail)
- Filed electronically through FDA's Prior Notice System Interface or through ABI/ACE
Required data elements include:
- Identity of the food (FDA Product Code, brand, common name)
- Quantity and packaging
- Manufacturer and grower
- FDA registration number of the manufacturing facility (food facility registration under section 415 of the FD&C Act)
- Country of production and country of shipment
- Anticipated arrival information
- Importer, owner, and ultimate consignee
- Carrier and mode of transport
Consequences of non-compliance: Food arriving without proper Prior Notice is subject to refusal of admission at the port of entry under 21 U.S.C. § 381(m). The food may be held at the port until Prior Notice is filed and FDA review is complete. Repeated violations can result in CBP penalties under 19 U.S.C. § 1592 and FDA enforcement actions.
Customs brokers handling food imports must coordinate Prior Notice filing alongside the standard entry summary process.