FDA Prior Notice checklist for food imports into the US

Last updated: 17 October 2026. Confirm each point with FDA before you ship.

Prior Notice tells FDA what food is arriving, from whom and when, before it reaches a US port. It applies to food shipments, including animal feed. FDA must confirm the notice for review 2 to 8 hours before arrival, depending on how the food travels. Food without adequate Prior Notice is subject to refusal.

When to submit.

The latest time depends on how the food arrives. FDA must have confirmed the notice for review at least this long before the food reaches the port:

• By road: 2 hours.
• By rail: 4 hours.
• By air: 4 hours.
• By water: 8 hours.

The earliest time is no more than 30 calendar days before arrival through CBP's ABI/ACE system, or no more than 15 calendar days through FDA's Prior Notice System Interface (PNSI). FDA replies with a PN Confirmation Number, and the notice counts as submitted from the moment FDA confirms it for review, not when you send it. Leave time for that confirmation.

What to have ready.

These are the main items required for an ordinary shipment under 21 CFR 1.281(a):

• Submitter and transmitter details, the entry type, and the CBP entry number if available.
• The food: its complete FDA product code, common or usual name, estimated quantity from the largest container to the smallest package, and lot or code numbers where required.
• The manufacturer for processed food (name, and registration number or full address), or the grower and growing location for food in its natural state.
• The FDA country of production, the country the food ships from, and the shipper if different from the manufacturer.
• The importer, the owner if different, and the ultimate consignee, with names and addresses.
• The anticipated port of arrival, arrival date and arrival time.
• The mode of transport, the carrier code, and shipment details such as the bill of lading or airway bill number, vessel and voyage, flight, container or rail car number.
• Any country that has refused entry of the food.

What happens without adequate notice.

Food with no, inaccurate or untimely Prior Notice is subject to refusal of admission. Refused food must be held within the port, or at a secure facility outside it, unless it is immediately exported under CBP supervision. It cannot be entered, and it cannot be delivered to the importer, owner or consignee. FDA and CBP are not liable for transport or storage costs.

After a refusal, the regulation allows 10 calendar days to submit a notice if none was filed. If a notice was inaccurate, it is cancelled and resubmitted within the same window. A request for FDA review can be made within 5 calendar days of the refusal. Read 21 CFR 1.283 for the exceptions and the full procedure. Lifting a Prior Notice refusal does not mean the food is admissible under other US laws.

Mail shipments have extra rules. FDA reports that from 1 October 2026 notices for food arriving by international mail must include the mail service name and a tracking number, but says it does not expect industry to submit them until 1 May 2027 under an enforcement policy.

Checks to run before you submit.

1. Compare the FDA product code and description with the commercial invoice and packing list.
2. Compare the manufacturer's name and registration number with the facility's registration record.
3. Compare the importer, owner and consignee names and addresses with the invoice and the customs entry.
4. Compare quantities, lot numbers and container numbers with the packing list and bill of lading.
5. Compare the port, arrival date, carrier and vessel or flight details with the booking and bill of lading.
6. Check that the country of production and the country of shipment are consistent across all documents.
7. Recheck whenever shipment details change before arrival. A changed shipment may need the notice amended or cancelled, so read 21 CFR 1.282.
8. Keep the PN Confirmation Number with the shipment records.

Common questions.

How far in advance must Prior Notice be submitted?

FDA must have confirmed the notice for review at least 2 hours before arrival at the port for food arriving by road, 4 hours by rail or air, and 8 hours by water. It may be submitted no more than 30 calendar days ahead through CBP's ABI/ACE system, or 15 calendar days ahead through FDA's PNSI.

What happens if Prior Notice is missing, late or wrong?

The food is subject to refusal of admission. Refused food must be held at the port or a secure facility, cannot be entered, and cannot be delivered to the importer or consignee. FDA and CBP are not liable for the costs of holding it.

What is a PN Confirmation Number?

It is FDA's reply when it confirms a Prior Notice for review. The notice counts as submitted from that point. For some shipments, such as submissions through PNSI, the number must accompany the food on arrival.

Sources.

• FDA, Prior Notice of Imported Foods (FDA's Division of Targeting and Analysis answers policy questions at prior.notice@fda.hhs.gov)
• eCFR, 21 CFR 1.279, When must prior notice be submitted to FDA?
• eCFR, 21 CFR 1.281, What information must be in a prior notice?
• eCFR, 21 CFR 1.283, What happens to food that is imported or offered for import without adequate prior notice?
• FDA, FDA updates amendments to its regulation for Prior Notice of imported human and animal food
• FDA, Guidance for industry: What you need to know about Prior Notice of imported food shipments

This guide is information, not legal advice. Read the regulation text and FDA's current guidance before you rely on a time limit.