FDA Prior Notice

Prior Notice came out of the Bioterrorism Act of 2002 and was extended by FSMA. The requirement is at 21 USC 381(m) and the operating rules are at 21 CFR part 1, subpart I. Every article of food offered for import needs one, and "food" is broader than people expect: it takes in food for animals, dietary supplements and beverages alongside anything you would put on a plate. Most filings go in through ABI alongside the entry. They can also be submitted directly through FDA's Prior Notice System Interface at access.fda.gov, which is what you fall back on when there is no entry to attach it to.

The timing windows, by mode

These are not rounded guidance. They are the regulatory minimums, and road and rail are different from each other, which is the detail most summaries get wrong.

Two things about that table. "Arrival" means arrival at the port of arrival, not delivery at your warehouse, so a truck crossing at Champlain is measured at the border and not at the consignee. And there is a ceiling as well as a floor, which depends on how you file. Through ABI/ACE, where the Prior Notice rides along with the entry and where most commercial filings go, a submission may not be made more than 30 calendar days before anticipated arrival. Through FDA's own PNSI the ceiling is 15 calendar days. Either way, filing a quarter ahead does not work, and a filing made too early has to be done again.

The fields that are never on the invoice

A Prior Notice wants the submitter and transmitter, the entry type and CBP identifier, the FDA product code, the common or market name, an estimated quantity expressed from the smallest package unit up to the largest container, lot or code numbers where they apply, the manufacturer, the grower where known, the shipper, the country of production, the country from which the article is shipped, and the anticipated arrival port, date, time, carrier and mode.

Two fields reliably stall a first-time importer:

• The food facility registration number of the manufacturer or processor. Foreign facilities that ship food to the United States have to be registered with FDA and to have named a US agent. That number is not on a commercial invoice or a packing list. It has to be asked for.
• The FSVP importer, identified by name, email address and a unique facility identifier, currently the DUNS number. This is how FDA connects a shipment at the port to the party carrying the supplier verification obligation, and an entry filed with a placeholder here is an entry that invites a follow-up you do not want.

Collect both at purchase order stage. Chasing a registration number across time zones while a reefer sits on a hold is the expensive way to do it.

2026 is a registration renewal year

Food facility registration under 21 CFR part 1, subpart H is not permanent. It renews on a two year cycle, in a window that runs from 1 October to 31 December of each even-numbered year. That makes the autumn of 2026 a renewal season, and a registration that is allowed to lapse on 1 January invalidates the Prior Notice behind every shipment that follows. The failure does not arrive as a letter. It arrives as a hold on a container that was already on the water.

What a hold actually looks like

An article that arrives without an adequate Prior Notice is subject to refusal of admission. It may not be delivered to the importer, owner or consignee. It stays at the port or is moved to a secure facility, and that movement and storage are at your expense. The procedures sit at 21 CFR 1.283 and 1.285.

Information that changes before arrival is handled by resubmitting. An article that is already here with a defective notice is a different problem, and the clock has stopped being on your side.

A reefer on hold bills demurrage, per diem and power at once, and the shelf life does not pause while the paperwork is corrected.

Worth separating from all of this: an Import Alert is not a Prior Notice problem. If your product, firm or country is listed for detention without physical examination, every shipment is held until you produce private laboratory results and, eventually, petition for removal. A perfect Prior Notice does not release cargo held under an Import Alert. Check the alerts against your supplier before the first order, not after the first detention.

What is outside the requirement

The exemption list is short. Meat, poultry and egg products under the exclusive jurisdiction of USDA at the time of arrival are outside Prior Notice, though they carry FSIS requirements of their own. So is food carried by a traveller for personal use, and food made by an individual in a personal residence and sent as a personal gift. Assume everything commercial is in scope.

Prior Notice is not FSVP

Prior Notice is per shipment and it is checked at the port. The Foreign Supplier Verification Program at 21 CFR part 1, subpart L is a standing obligation on the US importer to verify that each foreign supplier produces food to US standards, with hazard analysis, verification activities and written records. FDA audits it away from the port, usually months later, and the FSVP identification you gave at entry is how they find you. Clearing a shipment is not evidence that your FSVP file would survive an inspection.