FDA Domestic Food Facility Registration

FDA Domestic Food Facility Registration is the registration required under section 415 of the FD&C Act for a covered U.S. facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States, unless an exemption applies. Registration is facility-based and does not mean that FDA has approved the facility or its products.

A domestic facility that manufactures, processes, packs, or holds food for U.S. consumption generally must register unless it qualifies for an exemption under 21 CFR 1.226. Common examples of covered facilities include manufacturers, processors, packers, co-packers, and some warehouses or holding facilities.

A warehouse or storage facility that holds food for human or animal consumption in the United States generally must register if it meets the definition of a facility and no exemption applies. The specific activities and business model should be reviewed before filing.

Food facility registration is renewed every two years, not annually. The statutory renewal period is October 1 through December 31 of each even-numbered year. 2026 is a renewal year. An annual professional service arrangement is separate from FDA's biennial renewal requirement.

Failure to register, update, or cancel a food facility registration when required is a prohibited act under the FD&C Act. A required registration that is not renewed by the end of the biennial renewal period is considered expired. FDA's statutory suspension authority is a separate enforcement mechanism tied to specific food-safety conditions.

FDA Registration Assistance charges $858 per year for its Domestic Food Facility Registration professional service, including filing support, registration updates, ongoing compliance assistance, and biennial renewal management when due. FDA itself charges no government fee for food facility registration, updates, renewal, or cancellation.

FDA Registration Assistance typically prepares routine domestic food facility registrations within 24–48 hours after complete facility information and a valid UFI are available. Timing can be affected by missing information, UFI/DUNS verification, or FDA system issues.

Food facility registration generally requires the facility's legal and trade names, physical address, owner/operator or agent-in-charge information, emergency contact information for a domestic facility, food product categories, facility activities, a recognized Unique Facility Identifier such as DUNS, and certification by an authorized person.

Yes. Most changes to required registration information must be submitted to FDA within 60 calendar days. A change in ownership is handled differently: the former owner must cancel the existing registration and the new owner must register the facility.

The requirement is based on section 415 of the Federal Food, Drug, and Cosmetic Act, as established by the Bioterrorism Act of 2002 and amended by the Food Safety Modernization Act. FDA's implementing food facility registration regulations are in 21 CFR Part 1, Subpart H.

A distributor does not automatically register simply because it sells food. A physical location that manufactures, processes, packs, or holds food may need registration depending on its activities and whether an exemption applies, including the retail food establishment exemption where applicable.

FDA may suspend a facility's registration under section 415(b) of the FD&C Act when the statutory food-safety conditions for suspension are met. FDA may also treat a registration as expired when required biennial renewal is not completed. Cancellation, expiration, and suspension are different regulatory actions.

Dietary supplements are regulated as a category of food under the FD&C Act. A facility that manufactures, processes, packs, or holds dietary supplements generally may be subject to food facility registration unless an exemption applies.

FDA's exemptions in 21 CFR 1.226 include, among others, farms, retail food establishments, restaurants, private residences, certain nonprofit food establishments, certain fishing vessels, and facilities regulated exclusively throughout the facility by USDA under specified meat, poultry, or egg-product laws. The facts should be reviewed before relying on an exemption.

FDA Industry Systems includes the Food Facility Registration Module (FFRM), the online system used for food facility registration, updates, biennial renewal, cancellation, and related registration functions. Electronic submission is generally required unless FDA grants an applicable waiver.

Yes. FDA Registration Assistance can prepare and submit the registration when authorized, review facility and UFI information, support required updates, and manage biennial renewal when due. The facility should retain its own business and registration records and protect its FDA account credentials.

No. The food facility U.S. Agent requirement applies to foreign facilities that are required to register. A domestic facility provides domestic emergency contact information as required by the registration rule.

No. FDA states that food facilities do not need a certificate of registration and that FDA does not issue or recognize private food facility registration certificates. FDA assigns a registration number to a successfully registered facility.

No. Food facility registration is not FDA approval, clearance, certification, or endorsement of the facility or its products. Most conventional foods are not individually preapproved by FDA before marketing.

Yes. FDA states that if a food facility registers before October 1 during an even-numbered year, it must still renew during that year's October 1 through December 31 biennial renewal period.

Food facility registration is tied to the physical facility and its activities. Separate physical locations that independently meet the definition of a facility generally require separate registration analysis and, when required, separate registrations.

A change in ownership is not handled as a normal registration update. The former owner must cancel the existing registration within 60 calendar days of the ownership change, and the new owner must register the facility.

A private residence is not considered a facility for food facility registration purposes. However, a commercial facility located at or associated with a residence may need separate analysis, and state or local requirements can still apply.

Restaurants and retail food establishments are among the exemptions identified in the food facility registration regulations when the operation meets the applicable definition. A business that does not meet the exemption may still need registration.

FDA requires a Unique Facility Identifier recognized as acceptable for food facility registration. FDA currently recognizes the Dun & Bradstreet DUNS number as an acceptable UFI and uses it to help verify the identity and physical location of the facility.

Yes. FDA allows the owner, operator, or agent in charge to authorize an individual to submit a food facility registration on the facility's behalf. FDA does not require the facility to use a third-party registrar.