US FDA Food Facility Registration for Global Food Manufacturers
FDA food facility registration is the legal requirement for every facility that manufactures, processes, packs or holds food, beverages or dietary supplements for consumption in the United States to register with the Food and Drug Administration. It applies equally to facilities outside the USA, which must also name a US Agent. The FDA charges no fee, and registrations are renewed every two years between 1 October and 31 December. This guide explains who must register, what the FDA asks for, the renewal rules and how Prior Notice fits in.
Definition
What Is FDA Food Facility Registration?
FDA food facility registration is a registration of the site, not of the food product. The owner, operator or agent in charge tells the FDA where the facility is, who is responsible for it, which food categories it handles and who can be reached in an emergency. The FDA then issues a registration number for that facility.
The requirement comes from section 415 of the Federal Food, Drug, and Cosmetic Act, introduced by the Bioterrorism Act of 2002 and strengthened by the Food Safety Modernization Act (FSMA) in 2011. The detailed rules are in 21 CFR Part 1, Subpart H. Under FSMA, every registration also contains an assurance that the FDA may inspect the facility.
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Scope
Who Must Complete FDA Food Facility Registration?
The duty depends on what happens at the site. If food for people or animals in the USA is manufactured, processed, packed or held there, the facility registers, whether it is in the USA or abroad.
| Type of site | Must register? | Notes |
|---|---|---|
| Food and beverage manufacturers and processors | Yes | Includes ingredients, additives and packaged foods |
| Dietary supplement manufacturers | Yes | Supplements are regulated as food |
| Packers, repackers and labellers | Yes | Packing is a registrable activity |
| Warehouses and cold stores holding food | Yes | Holding food for US consumption is covered |
| Animal food and pet food facilities | Yes | Same registration system |
| Farms | No | Exempt when acting only as a farm |
| Restaurants and retail food establishments | No | Exempt when food is sold directly to consumers |
| Facilities regulated only by the USDA | No | Meat, poultry and egg product plants |
| Foreign facility whose food is further processed abroad | No | Exempt if another foreign facility carries out further manufacturing or processing before export |
Exemptions are narrow. A farm that also processes food, or a foreign facility that only adds labels after another site makes the food, can fall inside or outside the rule depending on the activity. We check this before registering.
Outside the USA
How Do Foreign Food Facilities Register with the FDA?
A foreign food facility registers in its own name and does not need a US company. It must designate a US Agent under 21 CFR 1.232: a person who lives or keeps a place of business in the USA and is physically present there. The FDA treats the US Agent as its communication link with the facility and contacts the agent to confirm that the appointment has been accepted.
I3CGLOBAL provides US FDA Agent Services for food facilities, so the registration does not depend on an importer or distributor.
Food exporters in India
Spice, tea, rice, snack, seafood, confectionery and supplement manufacturers register the Indian facility and name a US Agent. The facility name and address must match the DUNS record exactly.
Manufacturers elsewhere in Asia
Contract packers that supply several US brands register the site once. Each additional site, including a separate warehouse, needs its own registration.
Manufacturers in Europe
EU food hygiene approval or a BRCGS or IFS certificate does not replace FDA registration. The facility still registers and names a US Agent.
Process
How Does FDA Food Facility Registration Work?
- Confirm that the facility must registerCheck the activities at the site against the exemptions for farms, retail and further processing abroad.
- Appoint a US AgentRequired for every foreign facility. The agent must accept the appointment when the FDA asks.
- Find and check the DUNS numberThe name and address in the DUNS database must be identical to the registration. Correct the record, or obtain a number, before submitting.
- Create an FDA Industry Systems accountThe registration is entered in the Food Facility Registration Module.
- Enter the facility details and food categoriesFacility, parent company, owner or operator, emergency contact, trade names and the food product categories handled.
- Submit and receive the registration numberThe FDA issues a registration number and PIN for the facility. Keep both confidential; importers will ask for the number for Prior Notice.
Documentation
What Information Does FDA Food Facility Registration Require?
| Information | Notes |
|---|---|
| Facility name, physical address and telephone | Must match the DUNS record |
| Unique facility identifier (DUNS number) | Required for registration and renewal |
| Parent company name and address | If the facility is a subsidiary |
| Owner, operator or agent in charge | Name, address, email and telephone |
| Emergency contact | A person reachable at any time |
| US Agent details | Foreign facilities only; name, address, telephone and email |
| Trade names | All names the facility uses |
| Food product categories | Selected from the FDA list, for example bakery, beverages, spices, dietary supplements |
| Type of activity | Manufacturer, processor, packer, warehouse and similar |
| Inspection assurance | Statement that the FDA will be permitted to inspect the facility |
Maintenance
When Must FDA Food Facility Registration Be Renewed?
Every registered food facility renews between 1 October and 31 December of each even-numbered year, whenever it first registered. For the current cycle the FDA states that it “will consider the registration to be expired for any facility that fails to renew by December 31, 2026” (FDA). Food from a facility with an expired registration can be held at the US port of entry.
| Event | What to do | When |
|---|---|---|
| Biennial renewal | Confirm or correct every field and resubmit | 1 October to 31 December, even-numbered years |
| Change of required information | Update the registration | Within 60 days of the change |
| Change of owner | Previous owner cancels; new owner registers | Within 60 days |
| Facility closes or stops handling food | Cancel the registration | Within 60 days |
| Change of US Agent | Update the registration and have the new agent confirm | As soon as the change takes effect |
FDA fees do not apply, but service and US Agent fees do. See our FDA food facility registration fee page.
Import
How Do Prior Notice and Labelling Relate to Registration?
Registration lets a facility supply food to the USA. Each shipment then needs Prior Notice: an electronic notification filed with the FDA before the food arrives, under 21 CFR Part 1, Subpart I. Prior Notice identifies the manufacturer, normally by its registration number, so an expired or incorrect registration stops shipments.
Registration does not check the label. Food and supplement labels must separately meet US rules on the statement of identity, net quantity, ingredients, allergens and nutrition or supplement facts. See FDA Labeling Requirements.
A facility-level notification that gives the FDA your details and a registration number for import paperwork.
An approval of the facility or the food, a certificate of quality, or permission to use the FDA logo. See FDA Registration Certificate.
Avoidable problems
What Are the Common Food Facility Registration Mistakes?
- Forgetting the biennial renewal. The registration expires on 31 December and shipments are refused in January.
- DUNS and registration addresses that differ. Even small differences in spelling or unit number cause rejection.
- Using the importer as US Agent. The registration is exposed if the commercial relationship ends.
- Registering one site for several locations. Each physical facility, including separate warehouses, needs its own registration.
- Describing the product as “FDA approved”. Food facility registration is not an approval.
- A US Agent who does not confirm. The FDA can treat the registration as invalid if the named agent does not accept the role.
Work with I3CGLOBAL
How Does I3CGLOBAL Handle FDA Food Facility Registration?
- Check whether the facility must register and under which activities
- US Agent service based in the USA
- DUNS record check before submission
- Registration, biennial renewal and updates
- Support for food and supplement exporters in India, Asia and Europe
Start your food facility registration
Send us the facility address, DUNS number if available and your product categories.
FAQs
FDA Food Facility Registration: Frequently Asked Questions
What is FDA food facility registration?
It is the mandatory registration with the US Food and Drug Administration of any facility that manufactures, processes, packs or holds food, beverages or dietary supplements for consumption in the United States. It is required by section 415 of the FD&C Act and 21 CFR Part 1, Subpart H.
Do foreign food manufacturers have to register with the FDA?
Yes. A facility outside the USA must register before its food is exported to the USA, and it must name a US Agent. The only general exception is a foreign facility whose food is further manufactured or processed by another foreign facility before export.
Is there an FDA fee for food facility registration?
No. The FDA states that there is no fee for registration or renewal. Fees charged by consultants and US Agents are service fees.
How often must FDA food facility registration be renewed?
Every two years, between 1 October and 31 December of each even-numbered year. The current deadline is 31 December 2026. A registration that is not renewed is treated as expired.
Do dietary supplement manufacturers need food facility registration?
Yes. Dietary supplements are regulated as food, so facilities that make, pack or hold them register as food facilities.
What is a UFI or DUNS number?
The unique facility identifier is a number that identifies the physical site. The FDA currently accepts the DUNS number, issued free of charge by Dun & Bradstreet, as the unique facility identifier.
Does FDA food facility registration mean the food is FDA approved?
No. Registration identifies the facility to the FDA. The FDA does not approve food facilities or most food products, and a registration number must not be presented as an approval.
What is FDA Prior Notice?
Prior Notice is an advance electronic notification to the FDA of each shipment of food imported into the USA. It is separate from facility registration, but it normally quotes the registration number of the manufacturing facility.