FDA Prior Notice for Imported Food: What Foreign Exporters Must File Before Every Shipment

Every shipment of food — whether for humans or animals — entering the United States must be preceded by a Prior Notice filing with the FDA. This is not optional, it is not waivable, and there is no minimum shipment size that exempts you. A single pallet of spices from India, a full container of canned goods from Thailand, and a sample box of confectionery from Germany all require Prior Notice before the goods arrive at a US port. Failure to file — or filing with errors — results in the shipment being refused admission, held at the port, or returned at the exporter's expense.

What is FDA Prior Notice and why does it exist

Prior Notice was introduced under the Bioterrorism Act of 2002 as a food defense measure. The requirement gives the FDA advance information about incoming food shipments so the agency can assess risk before goods arrive. The filing must be submitted and confirmed by the FDA before the food physically arrives at the US port of entry. The system is administered through two channels: the FDA Prior Notice System Interface (PNSI), which is a web-based form accessible to anyone, and the Automated Broker Interface of the Automated Commercial Environment (ABI/ACE), which is used by customs brokers and freight forwarders.

Filing timelines by mode of transport

The FDA requires Prior Notice to be submitted no later than a specific window before arrival, and the window depends on how the food is transported. For food arriving by water, the filing must be confirmed no less than 8 hours before arrival. For food arriving by air or land rail, the window is 4 hours. For food arriving by land road transport, the window is 2 hours. For food arriving by international mail, the filing must be received before the food arrives, and as of October 2026, the submission must also include the mail service name and tracking number. If you file through the PNSI, you cannot submit more than 15 calendar days before the anticipated date of arrival.

Required information in a Prior Notice filing

The filing must include the identity of the food article using the FDA product code, the common or market name of the food, the estimated quantity and packaging information, the name and registration number of the manufacturing facility, the name and address of the shipper, the name and address of the importer or consignee, the anticipated port of entry, and the anticipated date of arrival. For food that has been refused admission previously, additional information may be required. Every data field must be accurate — a wrong FDA product code, an expired facility registration number, or an incorrect port of entry will cause the filing to fail or the shipment to be held.

Common Prior Notice mistakes that cause shipment holds

The most frequent error is submitting Prior Notice with an FDA facility registration number that has lapsed. FDA food facility registrations must be renewed biennially during the October–December renewal window in even-numbered years. If a manufacturer's registration expired because they missed the renewal, every Prior Notice filing referencing that registration number will be rejected. The second most common error is a mismatch between the product description in the Prior Notice and the product as it appears at the port — different product codes, different quantities, or a manufacturer name that does not match the FDA record. The third issue is timing: exporters who file too late or who file before confirming the actual arrival date end up with invalid filings.

Who is responsible for filing Prior Notice

The regulation places the filing obligation on the person who submits the food for import. In practice, this is usually the customs broker, the importer, or the US Agent acting on behalf of the foreign facility. Foreign exporters often assume their freight forwarder handles Prior Notice automatically — this is sometimes true, but not always. If the forwarder does not file, or files incorrectly, the shipment is held and the costs fall on the exporter. FDABridge recommends that every foreign food exporter confirm explicitly, in writing, who will handle Prior Notice filings and verify that the responsible party has access to the correct facility registration data.

How FDABridge helps with Prior Notice and import compliance

FDABridge ensures that your FDA food facility registration stays current, your US Agent is properly designated, and your facility data is accurate across all systems so that Prior Notice filings go through without delays. We also provide guidance to your importer and customs broker to ensure the data they use matches your FDA records exactly. Visit fdabridge.com/food to see our food export services or fdabridge.com/contact to speak with our team.