US import compliance
FDA food facility registration and the biennial renewal
Facilities that manufacture, process, pack or hold food for consumption in the United States generally must register with the FDA unless an exemption applies. Required registrations must be renewed every two years. 2026 is a renewal year.
Last reviewed: September 22, 2026
01
The 2026 renewal window
| Opens | October 1, 2026, 12:01 AM |
|---|---|
| Closes | December 31, 2026, 11:59 PM |
| Cycle | Every even-numbered year |
Registration applies to facilities that manufacture, process, pack or hold food for human or animal consumption in the United States, including facilities outside the US. Registration applies to the facility and its activities; exemptions must be checked, including those for farms, retail food establishments and restaurants. Trading or importing alone does not determine whether a facility must register.
02
What a foreign facility needs
| US agent | A foreign facility must designate a US agent who lives in, or maintains a place of business in, the United States and is physically present there. The agent is the channel for FDA communication, and may also be authorized to submit the registration. |
|---|---|
| Unique Facility Identifier | Every registration must carry a UFI the FDA recognizes. The FDA recognizes the DUNS number, issued by Dun and Bradstreet, for this purpose. |
| Registration number | Issued on registration, and used downstream - notably in Prior Notice filings for the goods that site produces. |
03
What happens if the window is missed
If a registration is not renewed by 11:59 PM on 31 December of the renewal year, it is considered expired and removed. There is no grace period built into the date.
The damage shows up in the next shipment rather than immediately. Prior Notice for food that is no longer in its natural state requires the manufacturer name together with either the registration number, city and country, or the manufacturer full address and the reason no registration number is being provided (21 CFR 1.281(a)(6)).
That last clause is the trap. A lapsed registration does not stop the filing outright - it forces the filer to declare, on the record, that the producing site has no current registration number. That is not a neutral statement to put in front of the FDA about a consignment already on the water. Food from a foreign facility that is required to register but is not registered is also subject to being held at the port of entry (FD&C Act section 801(l); 21 CFR 1.285).
04
What a buyer should actually ask for
Asking whether a facility is registered is not enough. Where registration is required, also ask:
- What is the registration number, and when was it last renewed? A number alone says nothing about whether it is current.
- Who is the US agent, and is that designation still live? Agents change, and a lapsed agent can invalidate the registration channel.
- Does the registration cover the activity actually performed for these goods - manufacturing, packing, or only holding?
- Who is responsible for renewing it this quarter, and how will you be told it is done?
05
How we handle it
- Registration applicability checked for each producing site; registration number and current renewal status held where registration is requiredme
- US agent designation confirmed as part of qualification
- Renewal tracked against the biennial window, so a lapse is caught before a shipment is booked against it
- Status issued with the shipment document set, alongside the Prior Notice data the broker files from
Product programs this guide applies to
Next step
Planning a program that has to meet these requirements?
Send the product, target market, pack format and expected volume. We review the commercial fit and come back with the questions that matter before a quotation.
Source and scope
Source. Section 415 of the Federal Food, Drug, and Cosmetic Act; 21 CFR Part 1; and the FDA published guidance on food facility registration and biennial renewal. Prior Notice provisions are cited inline. FDA: food facility registration.
Scope. General information for commercial importers, not legal advice, and no substitute for verification with the FDA or your customs broker. Requirements and dates change; confirm the current position before relying on them.
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