FDA Domestic Food Facility Registration
Domestic facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States generally must register with FDA before beginning those activities, unless an exemption applies.
FDA Domestic Food Facility Registration — Quick Facts
The core requirements, deadlines, and fees in one place.
- Who Generally Must Register
- U.S. facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States, unless an exemption applies.
- Common Exemptions
- Farms, retail food establishments, restaurants, private residences, certain nonprofit food establishments, certain fishing vessels, and certain USDA-regulated facilities when the regulatory definitions are met.
- Domestic U.S. Agent
- Not required. The food-facility U.S. Agent requirement applies to foreign facilities that are required to register.
- Filing System
- FDA Industry Systems / FURLS Food Facility Registration Module (FFRM).
- Unique Facility Identifier
- A UFI recognized as acceptable by FDA is required. FDA currently recognizes the Dun & Bradstreet DUNS number as an acceptable UFI.
- FDA Government Fee
- $0. FDA does not charge a government fee for initial food facility registration, updates, biennial renewal, or cancellation.
- Our Professional Service
- $858/year. Includes domestic registration filing support, required registration updates, ongoing compliance assistance, and biennial renewal management when due.
- Renewal Cycle
- Biennial — October 1 through December 31 of each even-numbered year. 2026 is a renewal year.
- Update Rule
- Most changes to required registration information must be submitted within 60 calendar days.
- Ownership Change
- The former owner cancels the existing registration and the new owner submits a new registration for the facility.
Does Your U.S. Food Facility Need FDA Registration?
Under section 415 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1, Subpart H, a domestic facility that manufactures, processes, packs, or holds food for consumption in the United States generally must register with FDA unless an exemption applies.
Registration is submitted through FDA Industry Systems / the Food Facility Registration Module (FFRM). A registered domestic facility must keep required information current and renew during October 1–December 31 of each even-numbered year. Domestic facilities do not designate a food-facility U.S. Agent; that requirement applies to foreign facilities.
- Registration is facility-based — the physical location and its activities determine whether registration is required
- Common exemptions include farms, retail food establishments, restaurants, and private residences when the regulatory definitions are met
- A valid FDA-recognized Unique Facility Identifier (UFI), currently DUNS, is required for registration
- Domestic facilities provide emergency contact information but do not designate a foreign-facility U.S. Agent
Active food facility registrations that are required to renew must complete the biennial renewal between October 1 and December 31, 2026. FDA also advises facilities to protect FIS/FURLS usernames, passwords, registration numbers, and PIN information from misuse.
Domestic Registration Requirements & Ongoing Obligations
Registration applies to covered facilities, not automatically to every food business. The facility's activities, location, and any applicable exemption determine whether an FDA food facility registration is required.
Who Generally Must Register
A domestic physical facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States generally registers unless an exemption applies.
- Food manufacturers, processors, packers, and co-packers
- Warehouses and storage facilities when no exemption applies
- Dietary supplement manufacturing, packing, and holding facilities
- Animal food and pet food facilities that are subject to the registration rule
Registration Maintenance
The registration must remain accurate. Most changes to required registration information are submitted within 60 calendar days; an ownership change is handled through cancellation of the old registration and a new registration by the new owner.
- Register before beginning covered manufacturing, processing, packing, or holding activities
- Renew biennially: October 1–December 31 of each even-numbered year
- Update most required registration information within 60 calendar days of a change
- Protect FDA Industry Systems credentials, registration number, and PIN information
What the $858/Year Domestic Registration Service Includes
Your service fee is for professional compliance support. FDA itself charges no government fee for food facility registration.
Domestic Food Facility Registration filing support plus ongoing registration maintenance and compliance assistance.
Included in the service
Domestic Food Facility Registration — Key Compliance Facts
The deadlines and requirements that matter most for a U.S. food facility.
FDA Food Facility Registration Renewal Timeline
Food facility registration follows a two-year renewal cycle. Updates and ownership changes are separate from renewal.
October 1–December 31, 2026: active registrations that are required to renew complete the biennial renewal.
No biennial renewal window. Keep required registration information current and submit most changes within 60 calendar days.
October 1–December 31, 2028: the next biennial registration renewal window.
No biennial renewal window. Continue required updates and maintain accurate facility information.
If a facility registers before October 1 during an even-numbered year, FDA states that the facility must still renew during that year's October 1–December 31 renewal period.
Register Your Domestic Food Facility in 4 Clear Steps
A focused process from facility review through FDA filing and ongoing registration maintenance.
Submit Facility Information
Provide the physical facility address, owner/operator details, emergency contact, UFI/DUNS, food categories, and activities.
Regulatory Review
We review whether the location appears subject to registration, check the required facility data, and identify common UFI or classification issues.
FDA Filing
When authorized, we submit the registration through FDA's Food Facility Registration Module and provide the resulting registration records.
Updates & Biennial Renewal
We support required registration updates and manage the October–December biennial renewal when it is due under your service.
The Laws Behind Domestic Food Facility Registration
Domestic food facility registration is based on federal statute and FDA regulations — not a private certification program.
FD&C Act § 415 / Bioterrorism Act of 2002
Section 415 requires covered domestic and foreign facilities that manufacture, process, pack, or hold food for U.S. consumption to register with FDA unless an exemption applies.
FDA registration resources →21 CFR Part 1, Subpart H
The regulation covers who must register, exemptions, required registration information, updates, renewal, cancellation, and related food-facility registration requirements.
Read 21 CFR Part 1, Subpart H →Food Safety Modernization Act
FSMA added the biennial renewal requirement and expanded FDA's registration-suspension authority under specified food-safety circumstances.
FDA FSMA registration FAQs →Domestic Food Facility Registration — Key Comparisons
These are separate FDA concepts that businesses frequently confuse.
Domestic vs Foreign Food Facility Registration
Both are governed by the same food facility registration framework, but foreign facilities have an additional U.S. Agent requirement.
| Requirement | Domestic Food Facility | Foreign Food Facility |
|---|---|---|
| Facility Location | Located in the United States. | Located outside the United States. |
| Who Generally Registers | Covered U.S. facilities that manufacture, process, pack, or hold food, unless exempt. | Covered foreign facilities that manufacture, process, pack, or hold food for U.S. consumption, unless exempt. |
| U.S. Agent | Not required. Domestic facilities provide required emergency contact information. | Required for a foreign facility that is required to register. |
| UFI / DUNS | Required FDA-recognized UFI; FDA currently recognizes DUNS. | Same UFI requirement. |
| Renewal | Biennial: October 1–December 31 of even-numbered years. | Same biennial renewal cycle. |
| FDA Government Fee | $0 for food facility registration. | $0 for food facility registration; private U.S. Agent fees may apply. |
Food Facility Registration vs FSVP
Registration applies to a physical food facility. FSVP applies to the FDA-defined importer of covered imported food.
| Topic | Food Facility Registration | FSVP |
|---|---|---|
| Responsible Party | Owner, operator, or agent in charge of a covered food facility. | The FSVP importer for covered imported food, subject to exemptions and modified requirements. |
| What It Covers | The physical facility and its food manufacturing, processing, packing, or holding activities. | Foreign-supplier evaluation and verification for imported food. |
| When It Applies | When the physical facility is subject to the registration rule. | When food is imported into the United States and the importer/food is subject to FSVP. |
| Renewal / Maintenance | Biennial registration renewal plus required updates. | No biennial registration renewal; verification activities and records must remain current as required. |
| Can One Replace the Other? | No. | No. FSVP and facility registration address different regulated parties and obligations. |
Self-Register vs FDA Registration Assistance
FDA permits facilities to register directly. Professional support is optional and is separate from FDA's no-fee registration system.
| Aspect | Self-Register with FDA | FDA Registration Assistance |
|---|---|---|
| FDA Government Fee | $0. | $0 FDA fee; professional service fee is $858/year. |
| Registration Review | You determine whether the location must register and enter the required facility information yourself. | We review the facility role, UFI information, food categories, activities, and filing data before submission. |
| UFI / DUNS | You obtain and verify the facility identifier information. | We review the UFI / DUNS information for registration consistency and can provide separate DUNS assistance when needed. |
| Updates | You track and submit required updates. | Required registration updates are supported during the service term. |
| Biennial Renewal | You track the even-year October–December renewal window. | We manage the biennial renewal when due under the active annual service. |
| Ongoing Support | You handle FDA registration questions and account issues yourself. | Ongoing food facility registration compliance assistance is included in the professional service. |
Complete FDA Compliance Solutions
We offer a full range of FDA registration and compliance services to help your facility succeed in the U.S. market.
Foreign Food Facility Registration
Registration and U.S. Agent support for covered foreign food facilities exporting food to the United States.
Domestic Food Facility Registration
Registration, updates, and biennial renewal support for covered U.S. food facilities.
FSVP Compliance
FSVP program development and management for covered food importers, including supplier evaluation, verification activities, and records.
Biennial Registration Renewal
Food facility registration renews every two years, during October–December of even-numbered years. We manage the renewal when due.
Shipment Compliance Consulting
FDA import and shipment compliance support for registration, Prior Notice, FSVP, labeling, and entry issues.
HACCP Plan Development
HACCP support for seafood and juice operations, plus food-safety and preventive-controls support when applicable.
Label & Ingredient Review
Review food labels, Nutrition Facts, allergens, ingredient declarations, and claims for FDA compliance risks.
Import Alert Assistance
Review FDA Import Alert and detention issues and help prepare an appropriate corrective-action or removal strategy when available.
DUNS Request Assistance
Help obtain or verify the facility DUNS number used as an FDA-recognized Unique Facility Identifier for food facility registration.
Prior Notice Filing
Prepare and file FDA Prior Notice for imported food before arrival; required timing depends on the transportation method and exemptions may apply.
FSVP for Amazon Sellers
FSVP compliance support for e-commerce food importers that meet FDA's definition of the FSVP importer.
Food Canning Establishment (FCE-SID)
FCE registration and scheduled-process filing support for covered low-acid canned foods and acidified foods in hermetically sealed containers.
Domestic Food Facility Registration Terms Explained
Key terms you will see in FDA registration guidance and the FFRM filing system.
The FDA registration required for covered domestic and foreign food facilities under section 415 of the FD&C Act.
The FDA Industry Systems module used to register, update, renew, cancel, and manage food facility registrations.
An FDA-recognized identifier required with food facility registration submissions.
A Dun & Bradstreet identifier that FDA currently recognizes as an acceptable UFI for food facility registration.
Food facility registration renewal occurs during October 1–December 31 of each even-numbered year.
The 2011 law that, among other changes, added biennial food facility registration renewal and expanded FDA's suspension authority.
An individual with authority over a facility who may be involved in the registration process under the FDA food facility framework.
Domestic facilities provide emergency contact information as required by the registration form; this is distinct from the foreign-facility U.S. Agent role.
Food facility registration is tied to a physical location and its manufacturing, processing, packing, or holding activities — not simply to a brand name.
FDA assigns a registration number after successful registration. FDA has advised facilities to protect registration credentials and related account information.
Why Domestic Food Facility Registrations Run Into Problems
These are common registration and maintenance issues — not automatic FDA enforcement outcomes.
Registering When Exempt
FDA specifically warns businesses to register only when required. Farms, restaurants, retail food establishments, private residences, and other operations may be exempt when the definitions are met.
UFI / Address Mismatch
The physical facility information used in the FDA filing should be consistent with the facility's UFI / DUNS information.
Missed Biennial Renewal
A required registration that is not renewed by the end of the even-year renewal period is considered expired.
Late Registration Updates
Most changes to required registration information must be submitted within 60 calendar days.
Ownership Change Handled as an Update
A new owner does not simply edit the old owner's registration. The former owner cancels and the new owner registers the facility.
Wrong Product Categories or Activities
Food categories and activities should accurately reflect what the physical facility manufactures, processes, packs, or holds.
Sharing FDA Account Credentials
FDA's July 2026 advisory specifically cautions facilities about sharing FFR numbers, PINs, FIS/FURLS usernames, and passwords with third parties.
Treating Registration as FDA Approval
Food facility registration is a legal registration requirement. It is not FDA approval, certification, or endorsement of a food product or facility.
Frequently Asked Questions
Direct answers to the most common questions about domestic FDA food facility registration, renewal, exemptions, UFI/DUNS, fees, and ownership changes.
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.
Ready to Register Your Domestic Food Facility?
Send your facility details and our food compliance team will review your registration needs.