- Short answer
- Yes, except USDA-only food: FDA Prior Notice is due at least 2 to 8 hours before arrival, or before mailing, separate from facility registration.
- Who submits
- Any person with knowledge of the required information, not only the importer.
- Samples count
- Food for gifts and trade and quality assurance/quality control samples is covered; personal-use food carried on arrival is exempt.
- International mail
- File before the food is sent; the PN Confirmation Number goes on the customs declaration, such as CN22 or CN23.
- Costs of a refused shipment
- Neither FDA nor CBP is liable for transportation or storage expenses.
- Manufacturer on the notice
- If no longer in its natural state: name, plus registration number, city and country, or full address and reason.
Who has to file Prior Notice on food you import to sell?
Federal law requires that FDA receive prior notice of food imported or offered for import into the US. 21 CFR 1.277 extends it to food for gifts and trade and to quality assurance/quality control samples. Its personal-use exemption does not fit stock bought to resell, and meat, poultry and egg products under USDA's exclusive jurisdiction at import are outside the rule.
Filing is not reserved for the importer: any person with knowledge of the required information may submit the notice, but if no one does, the food can be refused admission or held.
When is Prior Notice due, and how do you file it?
21 CFR 1.279 sets a minimum lead time before arrival at the port, whether you file through FDA's Prior Notice System Interface or the Automated Broker Interface:
- Road: at least 2 hours
- Rail or air: at least 4 hours
- Water: at least 8 hours
For international mail, file before the food is sent, with the PN Confirmation Number on the customs declaration, such as CN22 or CN23. Beginning October 1, 2026, the mail notice also carries the name of the mail service and the mail tracking number.
Prior Notice is not facility registration. For food no longer in its natural state, the notice names the manufacturer and gives its registration number, city and country, or its full address and the reason the number is not provided. Whether your premises must register is a separate FDA question.
What happens if a shipment arrives without Prior Notice?
Food that reaches a port without a confirmed notice is subject to refusal of admission, and 21 CFR 1.283 has refused food held within the port of entry unless, with CBP's concurrence, it is immediately exported under CBP supervision, or CBP or FDA direct otherwise. The same section says who pays for that wait:
Neither FDA nor CBP are liable for transportation, storage, or other expenses resulting from refusal.
A parcel sent by international mail with inadequate notice, or without its confirmation number affixed, is held by CBP for 72 hours for FDA inspection and disposition.
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