If you export food to the United States, there is one filing that decides whether your shipment moves smoothly through the border or sits in a warehouse while someone sorts out paperwork. It is called Prior Notice. It is short, it is electronic, and it is easy to get wrong. A missing or late notice is one of the most common reasons food shipments are held, and by the time you find out the product may already be at the port.
This guide explains what Prior Notice is, who files it, when it is due, what information it needs and how to avoid the mistakes that cause delays. It is written for small and mid sized food producers and distributors shipping into the US, whether you are sending a first pallet or already trading regularly.
A quick note before we start: this article is a practical overview, not legal advice. The rules are set by the US Food and Drug Administration (FDA) and can change, so always check the current guidance on the FDA website or confirm with a customs broker or consultant before you ship.
What is FDA Prior Notice?
Prior Notice is an advance notification to the FDA that a shipment of food is about to arrive in the United States. It was introduced under the Bioterrorism Act of 2002 so that the FDA and US Customs and Border Protection (CBP) could review incoming food before it reaches the border and decide whether to inspect it.
The rule applies to food for people and animals, including ingredients, beverages, dietary supplements and pet food, that is imported or offered for import into the US. It covers commercial shipments of every size, from a full container to a small parcel of products sent to a buyer. It is separate from the other FDA requirements for food exporters, such as facility registration, which we cover in our food export compliance guide.
In simple terms: registration tells the FDA who you are. Prior Notice tells the FDA what is coming and when.
Who has to file it?
Anyone with knowledge of the shipment can submit it. In practice it is usually filed by one of the following.
The US importer or consignee. Many importers handle Prior Notice as part of their normal customs process.
A customs broker. Brokers file Prior Notice routinely and often include it in their entry service.
The foreign producer or exporter. You can file it yourself, but you will need the importer's details and the arrival information.
A carrier or freight forwarder. Some forwarders offer filing as a service.
The important point is that someone must be responsible for filing, and everyone in the chain should know who. The most common failure is not a wrong filing but no filing, because each party assumed another was doing it. Agree this in writing with your importer before the shipment leaves.
When is Prior Notice due?
Timing is where many exporters get caught. The notice must be submitted and confirmed by the FDA no later than a set number of hours before the shipment arrives at the US port. The minimum time depends on how the food is transported.
By road: at least 2 hours before arrival.
By rail: at least 4 hours before arrival.
By air: at least 4 hours before arrival.
By water (sea freight): at least 8 hours before arrival.
There is also an earliest date. Depending on the system used to file, a notice generally cannot be submitted more than 15 days before arrival if filed through the FDA's own system, or more than 30 days before arrival if filed through the customs system. Check the current limits for the system you use.
Two points matter in practice. First, the clock runs from when the FDA confirms the notice, not from when you press submit. If you file at the last moment and there is a problem, you can miss the window. Second, filing early is almost always better. Most experienced exporters file as soon as the shipment details are firm, so there is time to fix any errors.
How is it filed?
Prior Notice has to be submitted electronically. There are two main routes.
The FDA Prior Notice System Interface (PNSI). This is the FDA's own web based system. It is commonly used by exporters, small importers and anyone filing a one off shipment.
CBP's customs system (ACE). Customs brokers usually file through the customs entry system, so the Prior Notice becomes part of the entry. This is the normal route for regular commercial imports.
Which one you use depends on who is filing. If your importer uses a broker, the broker will normally file through the customs system. If you are filing yourself, the FDA's system is the usual choice. Either way you will receive a confirmation with a Prior Notice number, which should travel with the shipment documents.
What information do you need?
Exact fields depend on the system and the product, so use the current FDA guidance as the final reference. In general you will need details about the following.
The food. A clear description, the product category or FDA product code, the quantity and packaging, and any other details the system asks for.
The manufacturer. The name and address of the facility where the food was made, and in most cases its FDA registration number. This is why facility registration needs to be done first.
The growers, for some products. For certain unprocessed foods the notice may need information about the growing location.
The shipper and the importer. Names, addresses and contact details for the party sending the goods and the party receiving them in the US.
The country of origin and the country of production. Where the food was made and where it was shipped from.
The transport details. The carrier, the mode of transport, the arrival port and the expected arrival date and time.
Accuracy matters. The details in the notice need to match your commercial invoice, your packing list and the customs entry. Small mismatches, such as a different manufacturer name or a wrong quantity, can cause the FDA or CBP to question the shipment.
What happens after you file?
Once the notice is submitted, the FDA reviews it and the system issues a confirmation number if the notice is complete. Receiving a confirmation means the notice was accepted as complete. It does not mean the shipment has been approved to enter the US, and it does not mean the FDA has verified the information.
When the shipment arrives, CBP and the FDA match the goods against the notice. If everything lines up, the shipment moves on as normal. If the notice is missing, late or does not match, the shipment can be held at the port, and in some cases the food can be refused entry. Holds cost money: storage, demurrage charges, delays to your customer and, for fresh or chilled products, spoiled stock.
The most common mistakes
These problems come up again and again with food exporters, especially on a first shipment.
No one filed it. The producer assumes the importer filed. The importer assumes the broker filed. The broker assumes the producer did. Settle responsibility before shipping.
Filing too late. The notice was submitted close to arrival and was not confirmed in time. File early.
An unregistered facility. The manufacturer has not registered with the FDA, or the registration number was entered wrongly. Check your registration is current before you file.
Details that do not match. The notice says one thing and the invoice or packing list says another. Keep all documents consistent.
Wrong product information. An incorrect product code or description can lead to questions. If you are unsure, ask your broker or a consultant to check it.
Forgetting samples. Food samples sent to buyers or for a trade show can also need Prior Notice. Many exporters forget this because the quantities are small. Confirm the rules before you send any sample shipment.
Reusing an old notice. A Prior Notice relates to one specific shipment. You cannot reuse it for a later one.
A simple checklist before each shipment
Confirm your facility is registered with the FDA and the registration is current.
Agree in writing who will file the Prior Notice.
Gather the product, manufacturer, shipper, importer and transport details.
Check that your invoice, packing list and notice all match.
File early, and wait for the confirmation number.
Send the confirmation number with the shipment documents.
Keep a copy of the notice for your records.
How Prior Notice fits with the rest of US food import rules
Prior Notice is one piece of a larger compliance picture. Alongside it, exporters usually need to handle FDA facility registration, naming a US agent, labelling that meets US requirements, and a US importer who has a Foreign Supplier Verification Program in place. Meat, poultry, eggs and some dairy products come under the US Department of Agriculture and may have additional requirements. Our food export compliance guide lists these steps for exports between the US and Europe.
Compliance also shapes your costs and your choice of market entry route. If you are still working out whether to export to the US at all, our article on food market entry strategies between the US and Europe explains the order in which to approach compliance, pricing and partners, and our guide for small producers entering the US without a big budget covers the early decisions.
When to get help
You can handle Prior Notice yourself for a simple shipment if you have taken the time to learn the system. Many small producers prefer to get help, especially on a first shipment, because the cost of a mistake is high compared with the cost of a check. Consider outside help if this is your first US shipment, if you are shipping a regulated or perishable product such as dairy, meat or chilled goods, or if you do not yet have a US importer who understands the requirements.
At VC Agriculinary Consulting we help food producers and distributors plan compliant exports between the US and Europe, including regulatory coordination, import documentation and customs coordination, and introductions to importers and brokers who handle filings. You can see the full range of what we offer on our food trade consulting services page.
If you have a shipment planned and want a second pair of eyes on your documents, contact us with your product, your destination and your timeline, and we will tell you what to check first.
Frequently asked questions
What is FDA Prior Notice?
It is an advance electronic notification that a shipment of food is arriving in the US, filed so that the FDA and customs can review it before it reaches the border.
How far in advance do I need to file?
At least 2 hours before arrival by road, 4 hours by rail or air, and 8 hours by water, with confirmation from the FDA before the deadline. There is also a limit on how early you can file, so check the current rules.
Who files Prior Notice, the exporter or the importer?
Either can, and so can a customs broker or freight forwarder. What matters is that you agree who is responsible before the shipment leaves.
Do I need Prior Notice for food samples?
Often yes. Samples sent to buyers or to trade shows can need a notice even when the quantity is small. Check the rules before you ship.
What happens if I do not file or I file late?
The shipment can be held at the port or refused entry, which leads to storage costs, delays and possible loss of product.
Is Prior Notice the same as FDA registration?
No. Facility registration is a one time process, renewed regularly, that identifies your facility. Prior Notice is filed for each individual shipment.