US import compliance
FDA food facility registration and the biennial renewal
Every producing site that makes, processes, packs or holds food for the United States must be registered with the FDA, and that registration has to be renewed every two years or it simply expires. 2026 is a renewal year.
Last reviewed: 20 September 2026
01
The 2026 renewal window
| Opens | 1 October 2026, 12:01 AM |
|---|---|
| Closes | 31 December 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. It is the producing site that registers, not the trader and not the importer.
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 authorised to submit the registration. |
|---|---|
| Unique Facility Identifier | Every registration must carry a UFI the FDA recognises. The FDA recognises 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.
04
What a buyer should actually ask for
Is the facility registered is the wrong question, because the honest answer is almost always yes. Ask instead:
- 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 number and current renewal status held for every producing site in a programme
- 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
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.
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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