Who this covers
Food & beverage makers · co-packers · warehouses · dietary supplements (regulated as food) · pet food & animal feed · matcha/tea, snacks, sauces, infant-adjacent products
Food U.S. Agent services start at $249 per year per facility for FFR. Form 2541 process filing and TTB work are not in that fee. Not an FDA fee.
Food Facility Registration — Frequently Asked Questions
When is the FDA food facility registration renewal period in 2026?
FDA food facility registration should be renewed during the period beginning October 1 and ending December 31 of each even-numbered year. For 2026, FDA’s user guide states the renewal window runs from October 1, 2026, 12:01 a.m. through December 31, 2026, 11:59 p.m. Updating a registration is not the same as renewing; if a registration is not renewed by the deadline, FDA considers it expired.
Who should register a food facility with FDA?
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 should register with FDA unless an exemption in 21 CFR 1.226 applies. Examples of “food” for registration include dietary supplements and dietary ingredients, infant formula, beverages, produce, seafood, and animal food. Register before the facility begins those activities for U.S. consumption.
Do foreign food facilities need a U.S. Agent to register?
Yes—foreign facilities should designate a U.S. Agent (name, full address, phone, and email) as part of registration. FDA will not confirm the registration or provide a registration number until that agent confirms they agreed to serve. The agent must be physically present in the U.S. in the sense of residing or maintaining a place of business—not a mailbox-only arrangement.
Is there an FDA fee for food facility registration or renewal?
No. Under 21 CFR 1.231(c), no registration fee is required for food facility registration or renewal. Be wary of private businesses that imply FDA affiliation or invent official fees. Separate commercial services (such as a U.S. Agent) may charge their own fees; Axentra’s Agent services for food start at $249/year where applicable.
What is a DUNS / UFI for FDA food facility registration?
Beginning with applicable dates in the regulation, registrations should include a unique facility identifier (UFI) recognized as acceptable by FDA. FDA currently recognizes the Dun & Bradstreet D-U-N-S (DUNS) number as an acceptable UFI and verifies that the facility-specific address tied to the UFI matches the registration address. Obtain or verify DUNS via Dun & Bradstreet before submitting or renewing.
What happens if I miss food facility biennial renewal?
If registration is not renewed by December 31 of the even-numbered year, FDA considers the registration expired (21 CFR 1.241). Failure to register, renew, update, or cancel as required is a prohibited act under the FD&C Act framework described in that section. Food from an unregistered foreign facility may face import disposition procedures under the prior-notice / import rules. Renew early in the Oct–Dec window when possible.
Are farms and retailers exempt from FDA food facility registration?
Often yes, if they meet the definitions in 21 CFR 1.227 and the exemptions in § 1.226—for example certain farms, retail food establishments, restaurants, and nonprofit food establishments. Mixed-type facilities that also conduct non-exempt manufacturing/processing generally should register. Foreign facilities whose food undergoes further manufacturing/processing of more than a de minimis nature at another foreign facility before U.S. entry may also be exempt under § 1.226(a). When in doubt, map activities to FDA’s definitions rather than assuming a label (“farm”) alone decides the issue.
FDA Food Facility Registration & 2026 Biennial Renewal
Every foreign facility that manufactures, processes, packs, or holds food or beverages for U.S. consumption must register with the FDA and appoint a U.S. Agent — and re-register every two years. The next renewal window is Oct 1 – Dec 31, 2026. Miss it and your registration is deactivated, and shipments stop at the port. Axentra files it right, on time, every cycle.