Updated July 2026. Scope: FDA food facility registration under 21 CFR Part 1 Subpart H, for foreign companies shipping food to the United States. For the U.S. Agent role generally, see the guide on what a U.S. FDA Agent is and how to appoint one.
Key takeaways
- FDA food facility registration is required before a foreign facility manufactures, processes, packs, or holds food for consumption in the United States (21 CFR 1.225). Registration is free; getting it right and keeping it current is the work.
- Every foreign facility must designate a U.S. Agent (21 CFR 1.232). FDA treats what the U.S. Agent says as coming from the facility, and the agent cannot be a bare mailbox or answering service.
- Registration is not FDA approval or endorsement of your facility or products (21 CFR 1.242). A registration number confirms you registered, nothing more.
- Registrations expire. Every facility must renew during the window from October 1 to December 31 of each even-numbered year (21 CFR 1.230). 2026 is a renewal year.
Who needs FDA food facility registration
You must register if you are the owner, operator, or agent in charge of a domestic or foreign facility that manufactures, processes, packs, or holds food for consumption in the United States (21 CFR 1.225). “Food” here is broad and includes animal food.
Several categories are exempt under 21 CFR 1.226. Do not assume you are exempt without checking the definitions:
- Farms
- Retail food establishments
- Restaurants
- Nonprofit food establishments that prepare or serve food directly to consumers
- Fishing vessels (with limited exceptions for certain processing)
- Facilities regulated exclusively by the U.S. Department of Agriculture under the meat, poultry, and egg products inspection acts
The exemptions turn on how FDA defines each term, not on how the words are used day to day. A facility that thinks it is a “farm” or a “retail establishment” is not necessarily one under the regulation. This is a manual-review question, not a self-evident yes or no.
What registration actually requires
Registration is submitted to FDA at no charge. The information required for every facility (21 CFR 1.232) includes:
| Required information | Notes |
|---|---|
| Facility name, full address, phone | The physical facility, not only a head office |
| Unique Facility Identifier (UFI) | FDA currently recognizes the D-U-N-S number as an acceptable UFI. It is free for the first requests and can take up to 45 days to obtain, so start early |
| Parent company, trade names | Where applicable |
| Owner/operator/agent contact, with email | A monitored address |
| Food product categories and activity types | What the facility does |
| Inspection and certification statements | Including consent to inspection |
Two points that trip up foreign facilities: the UFI (DUNS) lead time can stall a registration if left to the last minute, and the registration must reflect the actual facility and its real activities, not a simplified version.
The U.S. Agent requirement for foreign facilities
A foreign facility must provide the name, address, phone, and email of a U.S. Agent (21 CFR 1.232). The regulation defines the U.S. Agent as a person residing or maintaining a place of business in the United States, designated as the facility’s agent for this subpart (21 CFR 1.227). What the role means in practice:
- The U.S. Agent is the communications link between FDA and the foreign facility, for both routine and emergency communications.
- FDA treats representations by the U.S. Agent as those of the foreign facility. The agent speaks for you to FDA.
- The agent cannot be a mailbox, answering machine, or service with no individual physically present. A parked address does not satisfy the requirement.
- Unless the facility designates another emergency contact, FDA uses the U.S. Agent as the emergency contact.
Because FDA acts on what the agent says, the agent needs a real, monitored channel into your regulatory team. This is an administrative and communication role. Designating a U.S. Agent does not move any of the facility’s obligations onto the agent.
The biennial renewal window
Registrations do not last indefinitely. Every facility must submit a renewal every other year, during the period beginning October 1 and ending December 31 of each even-numbered year (21 CFR 1.230). Miss the window and the registration can be cancelled, which can disrupt shipments into the United States.
2026 is an even-numbered year, so the renewal window is October 1 to December 31, 2026. Foreign facilities should confirm their UFI is still valid and their U.S. Agent details are current well before the window opens.
What registration is not
Registration is a notification to FDA, not a seal of approval. Assignment of a registration number does not convey FDA’s approval or endorsement of a facility or its products (21 CFR 1.242). Anyone claiming FDA “approval” from a registration is misreading the regulation.
Registration also does not, by itself, cover several separate obligations that apply to food imports. These are distinct programs with their own rules, and registering a facility does not satisfy them:
- Foreign Supplier Verification Programs (FSVP)
- Prior Notice of imported food shipments
- Food labeling and claims review
- Customs entry and importer-of-record responsibilities
- Recall handling
- Dietary supplement (DSHEA/NDI) requirements
- State-level licensing
Treat registration as one required step, not the whole compliance picture.
Frequently asked questions
Does FDA food facility registration cost money?
No. FDA does not charge a fee to register or renew a facility. Costs come from the work of preparing an accurate registration, obtaining a UFI, and maintaining a compliant U.S. Agent arrangement, not from FDA.
Do foreign facilities really need a U.S. Agent?
Yes. A foreign facility must designate a U.S. Agent as part of its registration (21 CFR 1.232). The agent must reside or maintain a place of business in the United States and be reachable as a real communications channel, not a mailbox.
Is a registration number the same as FDA approval?
No. A registration number means the facility is registered. It does not convey FDA approval or endorsement of the facility or its products (21 CFR 1.242).
When do we have to renew?
Every even-numbered year, between October 1 and December 31 (21 CFR 1.230). The next window is October 1 to December 31, 2026.
How long does it take to get a DUNS number for the UFI?
FDA currently recognizes the D-U-N-S number as an acceptable UFI. Obtaining one can take up to 45 days, so foreign facilities should request it well ahead of a registration or renewal deadline.
Related guides and services
- Food U.S. FDA Agent and Facility Registration services: registration support, a compliant U.S. Agent designation, FDA correspondence forwarding, and biennial renewal support for foreign food facilities.
- For the U.S. Agent role across FDA-regulated products, see what a U.S. FDA Agent is and how to appoint one.
This article is for general information only and is not legal or regulatory advice. Teams remain responsible for regulatory decisions and staying current with applicable regulations and guidance.
Talk to CENIT Consulting about food facility registration and U.S. Agent coverage: book a 30-minute consult.