FDA Food Facility Re-Registration

Re-Registration of Expired Food Facility Registrations with the US FDA

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities registered with the FDA to renew that registration between October 1 and December 31 of every even-numbered year (for example 2024, then 2026). This applies regardless of when the facility first registered — even a facility registered just before the window must still renew during it. There is no FDA fee to register or renew, and renewals are submitted electronically through the FDA Industry Systems (FURLS) account.

If a registration is not renewed by December 31 of the biennial renewal year, the FDA considers it expired and removes it from the account/system. Distributing food in the U.S. under an expired registration is prohibited, and shipments from such a facility are subject to detention at the U.S. port of entry.

Both domestic and foreign food facilities that intend to market products in the U.S. and have failed to renew by the deadline must re-register with the FDA before resuming operations. All re-registrations must also include a valid Unique Facility Identifier (UFI) — currently a DUNS number assigned by Dun & Bradstreet — which the FDA requires before it will confirm a registration or assign a registration number.

Facilities re-registering due to an incomplete biennial renewal should provide their old registration number on the new application; in this case the FDA re-assigns the same registration number to the facility.

If the registration was canceled for any other reason, the facility must submit a new registration and will be assigned a new FDA registration number.