US import compliance
FDA Prior Notice for food imports
A buyer guide, not a filing service. Food shipments subject to FDA Prior Notice must be declared before arrival: this page sets out who files, when, and which shipment and supplier details the filer needs. As seller, ALPHATRADE coordinates the manufacturing-facility and shipment information for its supply program with the appointed broker or filer; exemptions are checked for the specific consignment.
Last reviewed: September 22, 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 generally applies to food for people and food for animals, including repeat commercial shipments, unless an exemption applies. Applicability must be checked for the specific shipment.
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 traveling with the package (21 CFR 1.279(c), (e)).
One notice does not cover a program. 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
Any individual with knowledge of the required information may submit Prior Notice, including a manufacturer, exporter, importer, broker or US agent. Agree who will file and obtain FDA confirmation before the applicable deadline.
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
Check these common sources of incomplete or inconsistent filings before shipment.
- The facility registration number is wrong, missing or lapsed. FDA food facility registration renews only every two years. Failure to renew a required registration can result in the food being held, and submitting Prior Notice does not resolve the registration lapse.
- 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.
- Information that requires a new submission changed after filing, and no new notice was submitted. Under 21 CFR 1.282, changes to the estimated quantity, anticipated arrival or planned shipment details alone do not require one.
- 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 coordinates the supplier and shipment information agreed for the program, so the designated filer can prepare and verify the Prior Notice submission.
- 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 program is confirmed, not assembled after the goods are booked.
Product programs this guide applies to
Next step
Planning a program that has to meet these requirements?
Send the product, target market, pack format and expected volume. We review the commercial fit and come back with the questions that matter before a quotation.
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. FDA: Prior Notice.
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.
Inquiries: sales@alphatradecorp.com