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

Registering your facility with the FDA gets you into the US market. Prior Notice is what keeps each shipment moving. It is a separate filing, submitted to the FDA before every individual consignment of food arrives — and if it is missing, late, or inaccurate, your goods are held at the port of entry until it is corrected. For a perishable or time-sensitive product, that hold is the difference between a delivered order and a rejected one.

This guide explains what Prior Notice is, what it requires, when it must be filed, and how foreign exporters avoid the port holds that come from getting it wrong.

What FDA Prior Notice is

Prior Notice is an advance electronic notification to the FDA that a shipment of food is on its way to the United States. It was introduced under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is enforced for essentially all food for humans and animals imported or offered for import into the US — including ingredients, supplements, beverages, and pet food.

The purpose is simple: it lets the FDA know what food is arriving, from which facility, on which carrier, and when — so the agency can decide whether to examine it before it enters commerce. Without a valid Prior Notice on file, the FDA has no record of the shipment and will not allow it to clear.

Prior Notice vs. food facility registration — they are not the same

This is the single most common point of confusion, so it is worth being precise. Food facility registration is a one-time (renewed every two years) registration of the facility that manufactures, processes, packs, or holds the food. Prior Notice is filed per shipment, every time goods actually move to the US.

You need both. A registered facility with no Prior Notice on a given shipment will still see that shipment refused. A Prior Notice referencing an unregistered or lapsed facility will be rejected as inadequate. They work together: registration establishes the facility, Prior Notice clears each consignment.

What information Prior Notice requires

Each Prior Notice submission identifies the shipment in detail. In practice you need:

• The product, including its FDA product code and a description
• The manufacturer and the FDA registration number of the facility that made or processed it
• The grower or origin, where applicable
• The shipper and the country from which the food is shipped
• The importer, owner, and ultimate consignee in the US
• The carrier and mode of transport
• The anticipated US port of arrival, with the expected date and time

If any of these are missing or inconsistent with the facility's registration, the notice can be flagged as inadequate — which is why accuracy matters as much as timing.

Prior Notice deadlines: how far ahead you must file

Prior Notice must be submitted and confirmed electronically no more than five calendar days before arrival, and no fewer than:

• 2 hours before arrival by road (highway)
• 4 hours before arrival by air or by rail
• 8 hours before arrival by water
• For food arriving by international mail, before the shipment is sent

Miss the window on either side and the notice is untimely. Because these windows are tied to the exact carrier and arrival, Prior Notice is usually filed close to shipment — not weeks in advance.

The Prior Notice Confirmation Number — and why it must travel with the shipment

When a Prior Notice is accepted, the FDA issues a Prior Notice Confirmation Number. This number is the proof that the filing exists, and it must accompany the shipment so that it can be presented to the FDA and to US Customs and Border Protection at the port. A shipment arriving without its confirmation number — even one that was properly filed — can be delayed while the paperwork is reconciled. Keeping the confirmation number attached to the shipping documents is part of doing Prior Notice correctly.

Who can file Prior Notice

Prior Notice can be submitted by any party with the shipment information and authorization to act: the importer, the owner, the ultimate consignee, a US agent, a customs broker, or an authorized filing service. It is filed either through the FDA's Prior Notice System Interface (PNSI) or through the customs entry system (ABI/ACE) via a broker.

The FDA does not charge a fee to submit through PNSI. The real cost is operational: it has to be done accurately, for every shipment, inside the timing window, with data that matches the facility registration exactly. That per-shipment discipline is why most foreign exporters have an agent file it rather than manage the interface themselves.

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

A shipment without adequate and timely Prior Notice is refused entry and held at the port. It cannot be delivered, sold, or moved into US commerce until a corrected notice is accepted. For shelf-stable goods this means storage costs and delay; for perishable or seasonal products it can mean the loss of the entire consignment. Repeated problems also draw additional FDA scrutiny to future shipments. The filing itself is small; the cost of getting it wrong is not.

Common Prior Notice mistakes foreign exporters make

• Assuming registration is enough. Registration and Prior Notice are separate obligations; one does not cover the other.
• Filing outside the timing window — too early (more than five days) or too late (inside the minimum hours before arrival).
• Mismatched data between the Prior Notice and the facility registration, such as a wrong or outdated FDA registration number.
• Losing the confirmation number, so a validly filed shipment is still delayed at the port.
• Treating it as one-and-done rather than a filing that repeats for every single shipment.

How FDABridge files Prior Notice for you

FDABridge prepares and submits Prior Notice on your behalf for $99 per shipment. We confirm the data against your facility registration, file inside the correct timing window for your carrier and port, and return the Prior Notice Confirmation Number to travel with your goods — so your shipment clears instead of sitting at the border. If we already act as your US Agent and hold your facility registration, filing is faster still, because the facility data is already in place. Visit fdabridge.com/prior-notice for details or fdabridge.com/contact to get started.

Frequently asked questions

Is Prior Notice required for every shipment?

Yes. Prior Notice is filed per shipment — every individual consignment of food offered for import into the US needs its own Prior Notice, regardless of how many times the same product has shipped before.

How much does FDA Prior Notice cost?

The FDA charges no fee to submit Prior Notice through its Prior Notice System Interface (PNSI). FDABridge files it for you for $99 per shipment, including data verification and return of the confirmation number.

How early must Prior Notice be submitted?

No more than five calendar days before arrival, and no fewer than 2 hours (road), 4 hours (air or rail), or 8 hours (water) before arrival. For international mail, it must be filed before the shipment is sent.

Is Prior Notice the same as FDA food facility registration?

No. Registration is a biennial registration of the facility; Prior Notice is a separate filing made before each shipment. Both are required to import food into the US.

What is a Prior Notice Confirmation Number?

It is the number the FDA issues when a Prior Notice is accepted. It proves the filing exists and must accompany the shipment so it can be presented to the FDA and Customs at the port of entry.

Can my US Agent file Prior Notice for me?

Yes. A US agent or an authorized filing service can submit Prior Notice on your behalf. FDABridge files it for the exporters whose registrations and US Agent service we already manage.

Related reading

FDA Registration Numbers Explained: FEI, DUNS, and How the FDA Identifies Foreign Facilities — fdabridge.com/blog/fda-registration-numbers-explained-fei-duns-and-facility-identification

What Is a US FDA Agent — And Why Every Foreign Food Facility Must Have One — fdabridge.com/blog/what-is-a-us-fda-agent-and-why-every-foreign-food-facility-must-have-one

See all food registration services at fdabridge.com/food or learn about Prior Notice filing at fdabridge.com/prior-notice.