If you import food into the US for Amazon FBA, two FDA filings sit in front of the shipment: the factory that makes or packs the food must hold an FDA food facility registration, and someone must submit FDA Prior Notice for each shipment before it reaches the US port. According to FDA’s guidance What You Need to Know About Prior Notice of Imported Food Shipments (data checked 2026-10-05), Prior Notice is due no less than 2 hours before arrival by road, 4 hours by rail or air, and 8 hours by water, and “any individual with knowledge of the required information” can submit it. Food with inadequate Prior Notice “is subject to refusal and, if refused, must be held at the port of entry” unless directed to another location.
This guide covers the FDA side of a US food import headed to an Amazon fulfillment center. Amazon’s own category approval is a separate gate, explained in our Amazon gated categories guide, and the shelf-life labels Amazon checks at receiving are covered in Amazon FBA expiration date requirements. Every FDA fact below comes from FDA’s own pages and guidance documents.
Two Separate FDA Obligations: Registration vs Prior Notice
Sellers often treat “FDA registration” as one thing. It is two, with different owners and different timing.
| Food facility registration | Prior Notice | |
|---|---|---|
| What it covers | The facility (factory, packer, warehouse) | Each individual shipment |
| Who is responsible | Owner, operator, or agent in charge of the facility | Any individual with knowledge of the required information |
| When | Before the facility’s food is offered for import; renewed every other year | Before each shipment arrives (hours by mode) |
| Where it is filed | FDA’s online registration system | CBP’s broker interface (ABI) or FDA’s Prior Notice System Interface (PNSI) |
| FDA fee | None | Not mentioned in FDA’s guidance |
Sources: FDA Questions and Answers Regarding Food Facility Registration (Seventh Edition, August 2018); FDA Prior Notice guidance (content current as of 11/05/2018). Data checked 2026-10-05.
The two connect on the Prior Notice form: for processed food, it asks for the manufacturer’s registration number. That makes registration a prerequisite for every shipment, not paperwork you can postpone.
Does Your Product Count as “Food”?
FDA’s Prior Notice guidance defines food broadly: “Articles used for food or drink for man or other animals; chewing gum; articles used for components” of those articles. The guidance also says FDA “must be notified in advance of any shipments of food for humans and other animals that are imported into the U.S.” Pet treats are in scope alongside snacks, drinks, and gum.
The exemptions in the same guidance are narrow:
- Food carried by an individual arriving in the US for personal use.
- Food made in a private residence and sent as a personal gift.
- Food exported without leaving the port of arrival.
- Meat, poultry, and egg products under the exclusive jurisdiction of the US Department of Agriculture at the time of import.
None of these fit inventory shipped to an Amazon fulfillment center for resale. If your product is food under the FDA definition and it crosses the border to be sold on Amazon, plan on Prior Notice.
Prior Notice Deadlines by Shipping Mode
FDA sets both a latest and an earliest submission time. The latest depends on how the goods arrive; the earliest depends on which system you file through.
| Mode of arrival | Latest submission (per FDA guidance) |
|---|---|
| Land, by road (truck) | No less than 2 hours before arriving at the port of arrival |
| Land, by rail | No less than 4 hours before arriving at the port of arrival |
| Air | No less than 4 hours before arriving at the port of arrival |
| Water (ocean freight) | No less than 8 hours before arriving at the port of arrival |
| International mail | Before the food is sent |
| Filing system | Earliest submission |
|---|---|
| CBP ABI (used by customs brokers) | No more than 30 days before the shipment arrives |
| FDA PNSI (web portal) | No more than 15 days before the shipment arrives |
Source: FDA, What You Need to Know About Prior Notice of Imported Food Shipments. Data checked 2026-10-05.
On a China-to-FBA ocean shipment, the 8-hour floor is easy to meet on paper, which is exactly why it gets missed: nobody owns the task until the vessel is close. Assign Prior Notice in writing when you book freight, and ask for the confirmation number before the container is loaded. Our shipping from China to Amazon FBA guide shows where this fits in the freight timeline.
For mailed food, FDA adds one requirement: “The parcel must bear the Prior Notice confirmation number.”
Who Can File Prior Notice, and How
FDA’s guidance is explicit: “Any individual with knowledge of the required information can submit Prior Notice. This includes individuals, manufacturers, exporters, brokers, importers, and U.S. agents.” The Amazon seller does not have to file personally, and neither does the factory. What matters is that one named party files, on time, with correct data.
There are two electronic routes:
- CBP’s Automated Broker Interface (ABI). Customs brokers file through CBP’s systems. This is the route we recommend for FBA food shipments, because the broker is already preparing the entry and paying the duties covered in our Amazon FBA import tariffs guide.
- FDA’s Prior Notice System Interface (PNSI). FDA’s own web portal, referenced on FDA’s Prior Notice page (content current as of 10/01/2026). It suits a seller or exporter filing without a broker.
Once filing is complete, FDA’s guidance says “you will receive confirmation, including a confirmation number.” The next sentences matter: “This confirmation means that FDA has deemed your Prior Notice facially complete. The confirmation does NOT mean that FDA has determined your Prior Notice is accurate.” A confirmation number protects you from a missing filing, not from wrong data.
What a Prior Notice Must Contain
FDA’s guidance lists the data items. For a processed food product, these are what you will supply or confirm with your broker:
- Submitter details (and transmitter details, if someone else transmits for the submitter).
- Entry type and CBP identifier, if available.
- Product identity: FDA product code, common or market name, estimated quantity “from smallest package size to largest container,” and lot or code number if the food is required to have one.
- Manufacturer: “manufacturer’s name and either 1) the registration number, city, and country of the manufacturer, or 2) both the full address of the manufacturer and the reason the registration number is not provided.”
- FDA country of production, plus the country from which the food is shipped.
- Shipper’s name and full address.
- Anticipated arrival information: location, date, and time.
- Name and full address of the importer, owner, and consignee.
- Carrier, mode of transportation, and planned shipment information.
- “Any country to which the article has been refused entry.”
The manufacturer line is where FBA sellers get stuck. The “reason not provided” option is limited to reasons listed in FDA’s Compliance Policy Guide for Prior Notice, and it does not rescue food from an unregistered foreign factory (see below). Collect the factory’s registration number, city, and country before the purchase order, not after production.
Food Facility Registration: Which Facility Must Register
FDA’s registration Q&A states the rule: if you are “the owner, operator, or agent in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, you must register with FDA,” unless an exemption applies. For a seller sourcing from an overseas factory, these points from the same Q&A matter most:
Who registers. The factory that makes the product registers. A foreign storage facility holding food before export generally must register too, unless the food “subsequently undergoes manufacturing/processing of more than a de minimis nature in another foreign facility.” A foreign farm shipping its own food directly to the US is exempt; a facility that packs or processes that food afterward is not.
US agent. Foreign facilities name a US agent, who “must have a place of business or residence in the United States and be physically present in the United States.” FDA notes “a foreign facility may use its U.S. importer as its U.S. agent,” and “will not confirm your registration or provide you with a registration number until that person confirms that the person has agreed to serve as your U.S. agent.”
No FDA fee. “There is no fee associated with initial registration, updating a registration, renewing a registration, or canceling a registration.” Third-party agents may charge for their services. If a supplier quotes a fee for “FDA registration,” you are paying for an agent service, not a government charge.
Facility identifier. The Q&A names the DUNS number as the recognized unique facility identifier, “assigned and managed by Dun & Bradstreet and is available free of charge.”
Renewal. Facilities renew “every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year.” That window is open now, through December 31, 2026. A registration that is not renewed is treated as expired, so ask each supplier for proof of its 2026 renewal before you book 2027 freight.
What Happens When a Filing Is Missing or Wrong
The two failures play out differently at the port:
- Inadequate Prior Notice. Per FDA’s Prior Notice guidance, the food “is subject to refusal and, if refused, must be held at the port of entry unless directed to another location.” The guidance also calls importing food in violation of the requirements a “Prohibited Act” under the laws FDA administers.
- Unregistered foreign facility. Per FDA’s registration Q&A, the food “must be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food until the foreign facility is registered.” FDA or CBP may direct it to a secure facility, and FDA ordinarily will not allow anyone to move the food from the port into the US or out of that secure facility.
Neither page names a fixed dollar penalty. For an FBA seller the real cost is port storage, a missed inbound appointment, and stock aging while it waits. That compounds with Amazon’s shelf-life minimums: a two-week hold on a short-dated snack can turn a compliant shipment into one that fails at receiving.
FDA Checklist for an FBA Food Shipment
Run this before the purchase order and again before booking freight:
- Confirm the product is food under FDA’s definition (including pet food, drinks, and gum).
- Get the manufacturer’s FDA registration number, city, and country in writing.
- For shipments after December 31, 2026, ask for the factory’s 2026 renewal confirmation.
- Confirm the factory’s US agent has accepted the role; if it has none, your importer can serve.
- Check whether any foreign warehouse holds the finished goods before export, and whether it is registered.
- Name the Prior Notice filer (usually your customs broker) when you book freight.
- Give the filer product code, product name, package quantities, lot numbers, and shipper and consignee details.
- Get the confirmation number before departure, inside the 30-day (ABI) or 15-day (PNSI) window.
- Keep prep on schedule per our Amazon FBA prep requirements guide and check approval status via our Amazon category ungating guide.
Frequently Asked Questions
Does Amazon file FDA Prior Notice for FBA shipments?
FDA’s guidance lists individuals, manufacturers, exporters, brokers, importers, and US agents as eligible filers; it does not name Amazon or any marketplace. The simplest arrangement is to have your customs broker file it as part of the entry, and to get the confirmation number before the goods ship.
Do I need my own FDA food facility registration as an Amazon seller?
Registration attaches to facilities that manufacture, process, pack, or hold food for US consumption. If you buy finished goods from a registered factory and ship them straight to Amazon, the obligation sits with the factory. If you run your own warehouse that holds food, or you repack food, that facility falls under FDA’s rule.
How early can I submit Prior Notice?
According to FDA’s guidance (data checked 2026-10-05), no more than 30 days before arrival through CBP’s ABI, and no more than 15 days before arrival through FDA’s PNSI.
Sources and Conclusion
FDA sources used in this guide (data checked 2026-10-05):
- What You Need to Know About Prior Notice of Imported Food Shipments (content current as of 11/05/2018)
- Prior Notice of Imported Foods (content current as of 10/01/2026)
- Registration of Food Facilities and Other Submissions (content current as of 01/12/2026)
- Questions and Answers Regarding Food Facility Registration (Seventh Edition) (August 2018)
The FDA side of an Amazon food import comes down to one registration and one notice. The factory registers, keeps a US agent, and renews by December 31 of each even-numbered year. Someone you name files Prior Notice for every shipment inside the 2-, 4-, or 8-hour deadline. Settle both before the goods leave the factory, and the port stops being where your FBA launch stalls.