FDA Prior Notice: Deadlines, Required Information and How to File for Food Imports

FDA COMPLIANCE · FOOD AND SUPPLEMENT IMPORTS

Updated November 2026. If you import packaged food, beverages, supplements or pet food to sell on Amazon, Walmart, TikTok Shop or your own Shopify store, Prior Notice is one of the filings that decides whether your inventory clears the port on time. It is not the same as facility registration, and it is not a one-time task. It happens for every shipment. This guide covers who files, what goes in the filing, the deadlines, and the mistakes that cause holds. It is general information, not legal advice.

What is FDA Prior Notice?

Prior Notice comes from the Bioterrorism Act of 2002. It requires FDA to receive advance notice of food imported or offered for import into the United States, so the agency can decide which shipments to inspect before they arrive. For Prior Notice purposes, “food” uses the broad definition in the Federal Food, Drug, and Cosmetic Act: articles used for food or drink for people or other animals, chewing gum, and components of those articles. That covers dietary supplements, beverages, ingredients and animal food, not just groceries.

FDA’s own import manual describes the purpose plainly: advance notice lets FDA, with support from U.S. Customs and Border Protection (CBP), target import inspections more effectively.

What are the Prior Notice deadlines?

Under 21 CFR 1.279, Prior Notice must be submitted and confirmed by FDA no less than:

• 2 hours before arrival at the port of arrival, if the food arrives by land by road;
• 4 hours before arrival, if it arrives by air or by land by rail;
• 8 hours before arrival, if it arrives by water; and
• before the food is sent, if it travels by international mail. The PN Confirmation Number must appear on the customs declaration that goes with the package.

There is also an earliest date. A filing made through CBP’s automated broker system can go in no more than 30 calendar days before the anticipated arrival. A filing made through FDA’s Prior Notice System Interface (PNSI) can go in no more than 15 calendar days before arrival.

The clock runs to the port of arrival, which is the first U.S. port the food reaches, not the port where the customs entry is made. FDA’s Prior Notice guidance points this out because the two can be different.

Who submits Prior Notice?

Any person with knowledge of the required information can submit Prior Notice. In practice, for commercial shipments it is usually the customs broker filing through CBP’s system, or the importer or an authorized agent filing directly through FDA PNSI. For express courier shipments, the courier’s brokerage team often files.

The point for brand owners is that someone has to own it. When a supplier ships “DDP” or a freight forwarder handles customs, sellers often assume Prior Notice is covered. Confirm, in writing, who files Prior Notice for each lane and ask to see the PN Confirmation Number before the goods leave.

What information goes into a Prior Notice filing?

FDA asks for detailed information about the product, the companies involved and the trip. The core fields are:

1. Submitter and transmitter details, if different.
2. Entry type and CBP identifier for the shipment.
3. Product identity: the complete FDA product code, the common or usual name or market name, the estimated quantity from the largest container to the smallest package, and lot or code numbers where required.
4. Manufacturer name and address and its food facility registration number, or the reason a registration number is not provided.
5. Grower, if known, for whole foods such as produce.
6. Country of production and the country the food is shipped from.
7. Shipper, plus the importer, owner and ultimate consignee.
8. Arrival information: the anticipated port of arrival, date and time.
9. Carrier and mode of transportation details.
10. Any country that has refused entry of the article, where that applies.

The manufacturer registration number is where many ecommerce shipments go wrong. If your co-manufacturer’s food facility registration has lapsed or the address does not match, the filing carries bad data into every shipment. During 2026 this matters more than usual, because food facility registrations must be renewed between October 1 and December 31 of every even-numbered year, and a registration that is not renewed by December 31 is treated as expired.

How do you file Prior Notice through FDA PNSI?

If you are not using a broker’s system, PNSI is FDA’s web interface for Prior Notice. A typical filing runs like this:

1. Set up an FDA Industry Systems account with access to Prior Notice.
2. Gather the product codes, quantities, manufacturer registration numbers and shipment details before you start.
3. Create the web entry, add each article of food, and enter the arrival details.
4. Submit and wait for FDA’s confirmation. Prior Notice is only considered submitted, and the time only starts, once FDA confirms it for review.
5. Save the confirmation and give the PN Confirmation Number to whoever is moving the goods: the carrier, broker, or the person carrying the food.

Leave room for errors. A rejected or incomplete filing does not count, and the deadline is measured from the confirmed submission, not from when you started typing.

Does Prior Notice apply to shipments going to Amazon FBA?

Yes, in general. Prior Notice applies to food imported into the United States regardless of where it is going next. Sending inventory to an Amazon fulfillment center, a Walmart fulfillment center or your own 3PL does not change the import requirement. We cover the short version in our answer on whether food shipments to Amazon FBA need Prior Notice.

What changes for marketplace sellers is the cost of a mistake. A held container does not just delay a shipment, it can push an ASIN out of stock during a sales window, and inbound appointments may need to be rebooked. Building Prior Notice into your inbound checklist, next to labeling and carton requirements, is cheaper than recovering ranking after a stockout.

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

Food imported or offered for import with no Prior Notice, or with inadequate Prior Notice, is subject to refusal under section 801(m) of the Federal Food, Drug, and Cosmetic Act. FDA regulations say food in that situation is held at the port of arrival or moved under secure conditions to another location, and it cannot be delivered to the importer, owner or consignee until the problem is resolved. That means storage costs, missed delivery windows and, in some cases, export or destruction.

Common causes we see in ecommerce supply chains:

• No one owns the filing because the supplier, forwarder and seller each assumed someone else did.
• The product code or description does not match the product, especially for supplements and blended foods.
• The manufacturer’s registration number is missing, expired or tied to a different address.
• The arrival time changed and the filing was not updated.
• Samples and influencer shipments were sent by courier without Prior Notice because “it is only a few units.”

Are there exemptions?

Yes, but they are narrow. Food carried by or otherwise accompanying an individual for personal use is exempt, as is food made by an individual in a personal residence and sent as a personal gift for non-business reasons. Some products are excluded because they fall under the exclusive jurisdiction of the U.S. Department of Agriculture, such as many meat, poultry and egg products. Commercial ecommerce inventory almost never qualifies. Samples sent to a business count as commercial.

FDA’s guidance also notes that Prior Notice is required for food coming into the 50 states, the District of Columbia and Puerto Rico, including food coming from U.S. territories such as Guam, but not for food shipped into those territories.

How Prior Notice fits with your other FDA filings

Prior Notice is one piece of a set. For most imported food and supplements you also need to look at:

• Food facility registration for the facility that makes, packs or holds the product, renewed every two years.
• A U.S. Agent for each foreign facility that must register.
• Labels that meet FDA rules before the product ships, because a labeling problem can also lead to detention.

Our FDA registration and U.S. Agent guide covers each program, and our answer on whether Amazon food sellers need FDA registration covers who has to register.

How Eva Commerce helps with Prior Notice

Eva Commerce files Prior Notice for $30 per shipment when you provide the shipment details on time. We also serve as U.S. Agent for foreign food and supplement facilities ($250 per year), handle food or supplement facility registration ($240, biennial) and DUNS applications ($90, one-time), and review labels. Prices are on our FDA compliance services page. Because Eva also runs Amazon management and other marketplace work, we can line up Prior Notice timing with your inbound plan so inventory lands when your listings need it.

Prior Notice does not guarantee that a shipment will be admitted, and none of these filings mean FDA has reviewed or endorsed a product. Book a call or call 858-315-2020 to map your import lanes.

Frequently asked questions

How far in advance must FDA Prior Notice be submitted?

It must be confirmed by FDA at least 2 hours before arrival by road, 4 hours by air or rail, and 8 hours by water. For international mail it must be confirmed before the package is sent.

How early can I submit Prior Notice?

No more than 30 calendar days before anticipated arrival through CBP’s automated broker system, and no more than 15 calendar days before arrival through FDA PNSI.

Do dietary supplements need Prior Notice?

Yes. Dietary supplements are food under the Federal Food, Drug, and Cosmetic Act, so imported supplements need Prior Notice unless an exemption applies.

Is Prior Notice the same as food facility registration?

No. Facility registration covers the facility and is renewed every two years. Prior Notice covers each shipment and is filed before every arrival.

What happens if a food shipment arrives without Prior Notice?

It is subject to refusal and is held at the port or moved to a secure location until the issue is resolved. It cannot be delivered to the importer or consignee in the meantime.

Does Eva Commerce file Prior Notice?

Yes. Eva files Prior Notice for $30 per shipment when the shipment details are provided on time.

Sources: FDA, Prior Notice of Imported Foods; FDA, Prior Notice of Imported Food Questions and Answers (Edition 4); FDA, Investigations Operations Manual, Chapter 6 Imports; 21 CFR 1.276 to 1.285. General information, not legal advice.

Related Eva guides: FDA compliance services, FDA registration and U.S. Agent guide, Prior Notice for Amazon FBA.