What is FDA prior notice for imported food?

Prior notice is a per-shipment filing that tells FDA an article of food is on its way. The subpart applies to all food for humans and other animals imported or offered for import for use, storage, or distribution in the United States — including gifts, trade and quality-control samples, food in transit to another country, food for future export, and food entering a U.S. Foreign Trade Zone.

The timing depends on how the food arrives, measured before it reaches the port of arrival: no less than 2 hours ahead by road, 4 hours by rail, 4 hours by air, and 8 hours by water. There is also an outer limit on how early it can go in — no more than 30 calendar days ahead when filed through ABI/ACE, or 15 days ahead through the FDA Prior Notice System Interface. Food arriving by international mail is handled before it is sent.

The clock that matters is FDA's confirmation. The notice is treated as submitted, and the advance-time count begins, only when FDA confirms it for review and returns a Prior Notice Confirmation Number.

There are two ways in. The first is CBP's Automated Broker Interface of the Automated Commercial Environment (ABI/ACE) — the same system a customs broker uses to file the entry, so on a normal commercial import the prior notice usually rides along with the entry filing. The second is FDA's own Prior Notice System Interface (PNSI), a standalone web system for anyone who cannot, or chooses not to, file through CBP.

PNSI is the route for a shipment coming by international mail, for in-bond shipments or admissions into a Foreign Trade Zone, for a filer working when the CBP interface is unavailable, and for anyone who simply prefers an interactive web form. Either route submits the same information; which one applies depends on how the food is arriving and who is filing, not on the food itself.

Either route can carry it. On a normal commercial import a customs broker files prior notice through ABI/ACE alongside the entry, but prior notice does not require a broker: FDA's Prior Notice System Interface (PNSI) is a web system any submitter can use directly, and it is the route for food arriving by international mail, for in-bond and Foreign Trade Zone shipments, and for a filer working when the CBP interface is unavailable. Both routes submit the same information and return the same Prior Notice Confirmation Number — the web form is simply the self-service way in.

Prior notice is a defined set of data elements, not free text — 21 CFR 1.281 sets out what each submission carries. In practice that is: who is submitting it and, where different, who is transmitting it; the entry type and its CBP identifier; the food itself, by FDA product code, common or market name, estimated quantity, and lot or code numbers; the manufacturer, and the grower where the food is in its natural state; the country where it was produced and the country it is shipped from; the shipper; the arrival port, date, and time; the importer, owner, and ultimate consignee; the carrier and mode of transport; and any country that has refused the article entry.

A submission missing a required element is not facially complete, and an incomplete notice is not confirmed — which is what the confirmation number below turns on.

When FDA accepts a prior notice for review it returns a Prior Notice Confirmation Number. It means only that FDA has deemed the notice facially complete — not that FDA has judged it accurate, approved the shipment, or cleared the food to proceed. The advance-time count starts at this confirmation, not at the moment the notice was sent.

For a notice filed through FDA's Prior Notice System Interface, the confirmation number has to travel with the food and be available on arrival; for food arriving by international mail, the parcel itself has to bear the number.

The subpart does not reach food an individual carries in for personal use; food a person made in their own home and sent as a personal, non-business gift; food imported and then exported without ever leaving the port of arrival; meat, poultry, and egg products under the exclusive jurisdiction of the USDA at import; and food shipped as a diplomatic bag.

Prior notice may come from any person with knowledge of the required information — the submitter — and another person, often a customs broker or a filing agent, can transmit it on their behalf. The submitter and the transmitter can be the same person. The point for an importer is that this is a known, routine step, not a wall, but it is time-bound and tied to a confirmation from FDA.

Food imported or offered for import with inadequate prior notice is subject to refusal, and food that is refused must be held at the port of arrival unless it is directed to another location. Importing food without the required prior notice is a prohibited act under the statute.

That is why the timing and the confirmation carry as much weight as the filing itself: a notice that reaches FDA too late for its mode of transport, or that is missing a required element and so is never confirmed, leaves the shipment in the same position as one with no notice at all.

No. Prior notice is not a paper form. It is a set of data elements submitted electronically — by a customs broker or filer through CBP's ABI/ACE as part of the entry, or directly on FDA's Prior Notice System Interface (PNSI). What people search as the "prior notice form" is the PNSI web entry: FDA's own screens for the same data, which return a Prior Notice Confirmation Number when the submission is accepted for review.

FDA describes PNSI as available to individuals or companies that cannot, or choose not to, file through CBP. It runs on an FDA Industry Systems account, and its screens collect the elements 21 CFR 1.281 requires — who is submitting, the food and its quantity, the manufacturer and shipper, the country of production, the port and the anticipated arrival — then issue the confirmation number that accompanies the shipment. FDA publishes a PNSI user guide and a tutorial video for the system, and the timing rules are the same whichever route carries the notice.