FDA prior notice for imported food: deadlines, data and confirmation number

Every shipment of food for humans or animals coming into the US, including commercial samples and food sent by mail or courier, needs FDA prior notice before it arrives. The notice is filed electronically through CBP's ACE or FDA's Prior Notice System Interface (PNSI) within set time windows, and FDA confirms it with a PN confirmation number. Food without adequate prior notice is held at the port of entry.

Checked against official sources: 2026-10

At a glance

Minimum time before arrival2 hours by road, 4 hours by rail or air, 8 hours by water

Earliest filingNo more than 30 calendar days before arrival through ACE, or 15 calendar days through FDA PNSI

International mailBefore the food is sent; the PN confirmation number goes on the customs declaration (CN22 or CN23)

ConfirmationFDA issues a PN confirmation number; the time starts when FDA confirms the notice

PNSI filingsThe PN confirmation number must accompany the food and be given to CBP or FDA on arrival

ManufacturerFor food no longer in its natural state: name and registration number, or full address and the reason no number is given

RefusalsThe notice must list any country that has refused entry of the article

No or inadequate noticeThe food is held at the port of entry unless directed elsewhere

When prior notice must be filed

Prior notice must be submitted and confirmed by FDA no less than 2 hours before arrival by road, 4 hours by rail, 4 hours by air and 8 hours by water. It may not be submitted more than 30 calendar days before arrival through ABI/ACE, or more than 15 calendar days through FDA's PNSI. For international mail, prior notice must be filed before the food is sent, and the PN confirmation number must accompany the parcel and appear on the customs declaration, such as a CN22 or CN23.

FDA replies with a PN confirmation number, and the prior notice time starts when FDA confirms the notice for review. If the notice was filed through PNSI, or the food is carried by a traveller, the confirmation must accompany the food and be given to CBP or FDA on arrival. Food arriving with inadequate prior notice must be held at the port of entry unless it is directed to another location.

What a prior notice contains

Submitter and, if different, transmitter details
Entry type and CBP entry or in-bond number, if available
FDA product code, common or market name, estimated quantity and lot or code numbers where required
Manufacturer (with registration number) or, for food in its natural state, the grower if known
FDA country of production, shipper and the country from which the food is shipped
Arrival port, date and time, importer, owner, ultimate consignee, carrier and shipment details such as the bill of lading or air waybill number

Practical points for exporters

Prior notice is usually filed by the US importer's customs broker, but the exporter supplies most of the data: the FDA product code, quantities from the largest container to the smallest package, the manufacturer's FDA registration number, and the shipping details. For food that is no longer in its natural state, the manufacturer is identified by its registration number, or by its full address with the reason no number is given. The notice must also list any country that has refused entry of the article.

Commercial samples and small parcels also need prior notice: a courier or postal shipment of food is covered too, and for mail the confirmation number must be on the customs declaration before the parcel is sent. Make sure the commercial invoice, packing list and prior notice describe the same products and quantities, so FDA's review is not delayed.

Step by step

Confirm the manufacturer's FDA food facility registration is valid and get its registration number.
Find the FDA product code and prepare quantities from the largest container to the smallest package.
Send the broker the invoice, packing list, shipper, importer and transport details.
File prior notice through ACE or PNSI within the window: up to 30 or 15 days before, and at least 2, 4 or 8 hours before arrival.
Keep the PN confirmation number with the shipment, and put it on the CN22 or CN23 for mail.

Documents you usually need

PN confirmation number
Commercial invoice and packing list matching the prior notice
Manufacturer's FDA food facility registration number
Bill of lading or air waybill number, or express tracking number
CN22 or CN23 customs declaration for postal shipments

Common problems and how to avoid them

A food sample was sent by courier without prior notice.

What to do: Samples need prior notice too; file it before arrival or the parcel can be held at the port.

Prior notice was filed less than 4 hours before an air shipment landed.

What to do: Air shipments need prior notice confirmed at least 4 hours before arrival; file earlier.

The manufacturer's registration number is missing or invalid.

What to do: Give a valid registration number, or the full address with the reason no number is provided.

A postal parcel has no PN confirmation number on the CN23.

What to do: File prior notice before mailing and write the confirmation number on the customs declaration.

Sources

21 CFR 1.279: When must prior notice be submitted to FDA? Electronic Code of Federal Regulations (eCFR)
21 CFR 1.281: What information must be in a prior notice? Electronic Code of Federal Regulations (eCFR)
What You Need to Know About Prior Notice of Imported Food Shipments U.S. Food and Drug Administration (FDA)

Rules change often. This note is practical guidance based on the sources above, not legal advice. Confirm current requirements with the authority, your importer or a licensed customs broker before you ship.

Port codes by country

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Common questions

What is FDA prior notice?

An electronic notice to FDA, confirmed before arrival, that is required for every shipment of food for humans or animals imported into the US.

How far in advance must FDA prior notice be filed?

At least 2 hours before arrival by road, 4 hours by rail or air and 8 hours by water, and no more than 30 days before (ACE) or 15 days before (PNSI).

Do food samples need prior notice?

Yes. Samples and food sent by mail or courier also need prior notice; for mail, the confirmation number goes on the CN22 or CN23.

What happens if prior notice is missing?

Food with no or inadequate prior notice is held at the port of entry unless it is directed to another location.

Who files prior notice?

Usually the US importer's customs broker, using data from the exporter such as the FDA product code, quantities and the manufacturer's registration number.

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