US import compliance
FDA Prior Notice for food imports
Every consignment of food entering the United States must be declared to the FDA before it arrives. Filing is the importer's obligation — but most failed filings are caused by missing supplier data.
Last reviewed: 20 September 2026
01
What Prior Notice is
Prior Notice is an advance declaration to the US Food and Drug Administration that a shipment of food is on its way. It lets the FDA decide, before the goods land, whether to examine them. It applies to food for people and food for animals, and to every commercial consignment — not only first shipments.
It is separate from the customs entry, and separate from FSVP. A shipment can be commercially perfect and still be held because the Prior Notice was late, incomplete, or did not match the goods.
02
The deadlines
The notice must be submitted and confirmed by the FDA before the shipment arrives. Confirmed is the operative word: submitting at the deadline is not compliance if the FDA has not returned confirmation.
| Water (ocean freight) | 8 hours |
|---|---|
| Air | 4 hours |
| Land — by rail | 4 hours |
| Land — by road | 2 hours |
There is also a limit on how early a notice may be filed, and it depends on the system used.
| CBP ABI / ACE / ITDS | 30 calendar days |
|---|---|
| FDA PNSI | 15 calendar days |
Food sent by international mail is different again: the notice must be submitted and confirmed before the food is sent, and the confirmation number must appear on the customs declaration travelling with the package (21 CFR 1.279(c), (e)).
One notice does not cover a programme. A single Prior Notice cannot be filed to cover repeated shipments — each article of food, in each consignment, requires its own (21 CFR 1.281).
03
Who files it
The filer is the importer, or the customs broker or agent acting for them — not the overseas supplier. The FDA charges no fee to file through its own PNSI system.
But the filing is built almost entirely from data the supplier holds: who manufactured the goods, that facility's FDA registration number, where they were produced, where they were shipped from, and exactly what is in the container. If any of that is wrong the filing is wrong — and the consequence lands on the importer.
04
What happens if it is wrong
Food arriving without adequate Prior Notice is subject to refusal of admission. Refused goods may not be delivered to the importer, the owner, or the ultimate consignee — including to a third-party warehouse holding on their behalf (21 CFR 1.283(a)(2)(ii)).
In practice that means demurrage and detention running against a container that cannot move, on goods already paid for. For chilled and frozen consignments it can mean losing the cargo outright.
05
Why filings actually fail
These are the recurring causes, and every one of them is a data problem rather than a legal one.
- The facility registration number is wrong, missing or lapsed. FDA food facility registration renews only every two years; a producing site that has not renewed invalidates the filing, and nobody notices until the goods are held.
- The product code does not match what is in the container — common where a pack format or a variant changed after the order was placed.
- Quantities or lot numbers disagree with the invoice, packing list or bill of lading.
- Filed against the wrong deadline. Ocean freight needs 8 hours confirmed; a filing made as the vessel berths is already late.
- Details changed after filing and the notice was never updated — a vessel re-routed, a port of arrival switched, a consignee changed.
- A prior refusal was not declared. Where a consignment of that article has been refused entry by any country for a food-safety reason, it must be reported in the notice.
06
What we provide
ALPHATRADE issues a Prior Notice data set with every consignment, prepared so a broker can file directly from it without chasing the producing site.
- Producing facility identity and its current FDA registration number, with the registration period stated
- Country of production and country from which the goods are shipped
- Product identity and pack configuration matching the goods actually loaded
- Lot references and quantities reconciled against the invoice, packing list and bill of lading
- Shipper and consolidator details, and grower information where the category requires it
The same data set supports the FSVP file. Documentation is agreed before a programme is confirmed, not assembled after the goods are booked.
Source and scope
Source. Requirements above are drawn from 21 CFR Part 1 Subpart I and the FDA guidance Prior Notice of Imported Food — Questions and Answers. Specific provisions are cited inline.
Scope. General information for commercial importers, not legal advice, and no substitute for your customs broker or your own verification with the FDA. Requirements change; confirm the current position before filing.
Enquiries: sales@alphatradecorp.com