Every facility that needs an FDA food facility registration has to renew it between October 1 and December 31, 2026. There is no fee, and the filing goes online through your FDA Industry Systems account unless FDA has granted a waiver. With nothing changed since the last filing, a shorter abbreviated renewal is enough.
A renewal can look like a free form that a consultant or U.S. agent clicks every two years. The filing is short, and anyone the owner, operator or agent in charge authorizes may submit it. Before confirming a filing that changes them, though, FDA verifies the unique facility identifier and a foreign facility’s U.S. agent.
Getting the information behind the form right is basic FDA compliance for food facilities, whoever presses submit. The identifier should carry the same address as the registration. Contacts, product categories and activity types should match the facility as it runs today, and a facility abroad also needs a U.S. agent who has agreed to serve.
FDA will consider the registration expired for any facility that fails to renew by December 31, 2026, according to its September 29, 2026 renewal reminder. The cutoff in FDA’s user guide is 11:59 PM that night, with no time zone named. An expired registration is then removed from the facility’s account.
Renewing in 2026 and Reporting Changes
The window runs from October 1 to December 31 of each even-numbered year, under both the statute and 21 CFR 1.230. Online filing has been mandatory since January 4, 2020. Mail or fax stays open only to a facility granted a waiver after a written request explaining why online filing is not reasonable.
Someone other than the owner, operator or agent in charge may file with permission, certifying the filing personally and naming whoever gave it. FDA confirms the renewal only after the person who gave permission does.
With no changes since the last registration, renewal or update, a facility may file the abbreviated renewal, certifying the information as truthful and accurate. A facility with changes files in full. During the renewal period, the Update button stays hidden in FDA’s system until the registration is renewed.
Outside the renewal, a change to any required detail must be updated within 60 calendar days. The rule gives a new operator, agent in charge or U.S. agent as examples. Details that were wrong when filed must be corrected immediately.
When a facility changes owners, the former owner cancels within 60 calendar days of the sale. The buyer submits its own registration. Closing the facility, or ceasing to supply food for consumption in the United States, starts the same 60-day cancellation clock.
The UFI, DUNS Number and U.S. Agent FDA Verifies
Since October 1, 2020, every registration must include a unique facility identifier, or UFI, that FDA recognizes. A DUNS number currently qualifies. Dun & Bradstreet assigns and manages DUNS numbers, which can be obtained or verified on its website.
FDA verifies the identifier and checks that the address tied to it matches the address in the registration. No registration number issues until the UFI is verified. At renewal the same check runs whenever the identifier changes.
Every foreign facility must name a U.S. agent, a person living in the United States or keeping a place of business there. A mailbox, an answering service or a place with no individual physically present cannot serve. The registration lists the agent’s full contact details.
Statements the agent makes count as the facility’s own, and documents given to the agent count as given to the facility. In an emergency, the agent gets FDA’s call unless another contact is named. FDA verifies that the agent agreed to serve before issuing a registration number, repeating the check at any renewal that changes the agent.
The registration also lists the facility’s food product categories as identified on Form FDA 3537, with the type of activity for each. More than one of the rule’s 14 activity types may apply. FDA’s 2016 guidance on product categories has binding effect to the extent it modifies those categories for registration.
Before opening the renewal, I would answer the questions below. The first two match what FDA verifies, while the rule requires the rest to be accurate even when no one checks them. Only the U.S. agent question is limited to foreign facilities.
- Does the address on the facility’s DUNS record match the address in the registration?
- Foreign facilities only. Has the U.S. agent agreed to serve, with a current name, address, phone and email?
- Do the product categories and activity types still describe what the facility makes, packs or holds?
- Are the emergency contact and the owner’s email address still current?
- Is the owner the same as at the last filing?
Who Has to Register, and Who Does Not
The duty falls on the owner, operator or agent in charge of a facility in the United States or abroad. It covers every facility that makes, processes, packs or holds food for U.S. consumption, unless an exemption applies. A domestic facility registers whether or not its food enters interstate commerce.
Farms, restaurants and other retail food establishments sit outside the statute’s definition of a facility. Traders and brokers need not register either, FDA says. Several other exemptions in 21 CFR 1.226 depend on the conditions that follow.
| Who may fall outside the rule | What decides it |
|---|---|
| A foreign facility whose food is processed again abroad | Another facility abroad must further process or package the food. A label or similar minor step does not count. |
| A retail food establishment | By annual value, sales directly to consumers must exceed sales to all other buyers. Businesses are not consumers. |
| A nonprofit food establishment | The food is prepared for or served directly to the consumer. |
| A fishing vessel | Heading, eviscerating or freezing fish only to hold them on board is not processing. |
| A facility under USDA | USDA regulates the entire facility exclusively under the meat, poultry or egg products laws. |
| A private home | An individual’s private residence is not a facility. |
Businesses have been registering more often when they are not required to, as FDA noted in its July 20, 2026 update on protecting registration information. Registering without need may bring unnecessary inspections. It may also cause confusion over what FDA compliance requires of the business.
Expired, Canceled and Suspended Are Different Problems
Each status has its own trigger in the law. Expiry and cancellation turn on what the facility filed with FDA or failed to file. Suspension is an FDA order on public health grounds.
| Status | What causes it | What follows | What to do now |
|---|---|---|---|
| Expired | No renewal filed between October 1 and December 31 of an even-numbered year | The facility is treated as having failed to register, a prohibited act. FDA will cancel the registration. | Register again after cancellation, FDA guidance says, if the facility still makes, processes, packs or holds food for U.S. consumption. It must also remain subject to section 415. |
| Canceled | FDA cancels expired registrations, among other grounds in 21 CFR 1.241(c) | FDA sends a confirmation to the contacts on file. FDA guidance says a foreign facility’s U.S. agent stops serving. | After a sale, the new owner files a new registration. If canceled as expired, FDA guidance on registering again applies. |
| Suspended | An FDA order over a reasonable probability of serious adverse health consequences or death | No one may import, export or move the facility’s food in interstate or intrastate commerce | Use the informal hearing and, if FDA requires one, a corrective action plan |
Failing to register, renew, update or cancel as the rules require is a prohibited act under section 301(dd) of the FD&C Act. Remedies for these compliance mistakes in 21 CFR 1.241 include civil injunctions, criminal cases and debarment after a felony conviction tied to food importation. The rule does not say when those remedies would be used over a missed renewal.
FDA cancels a registration that expired for failure to renew and sends a confirmation to the contacts on file. The rule sets no date for doing so. Under FDA’s 2018 guidance, a facility that still makes, packs or holds food for U.S. consumption, and remains subject to section 415, must register again with the full required information.
Other grounds include a closed or sold facility no one canceled. For those grounds, a problem corrected within 30 days of notice is not expected to lead to cancellation. FDA’s nonbinding 2018 guidance states this expectation, which holds only when appropriate. An expired registration generally gets no such window, with FDA citing the notice facilities already have of the duty to renew.
Suspension rests on a public health finding. Section 415(b) of the FD&C Act lets FDA suspend a registration over food with a reasonable probability of causing serious adverse health consequences or death. The facility must also have caused that risk, or known of it and packed, received or held the food.
The registrant gets an informal hearing within 2 business days of the order, or another agreed period. If the evidence shows no adequate grounds to continue, the statute requires reinstatement. If suspension stays necessary, the registrant must submit a corrective action plan, which FDA reviews within 14 days or another period it sets.
Once the grounds no longer exist, the statute directs FDA to promptly vacate the order and reinstate the registration, or to modify the order. Section 415 authorizes no application, review or licensing process for registration except to reinstate a suspended one. Neither a failure to register nor a suspension by itself makes the food misbranded, in the view of FDA’s nonbinding Compliance Policy Guide 100.250.
When Food from a Foreign Facility Is Held at the Port
For a foreign facility selling into U.S. food distribution and international trade, a missing registration shows up at the border. Under section 801(l) of the FD&C Act, food from an unregistered or suspended foreign facility is held at the port of entry. The importer, owner or consignee cannot take delivery until the facility is registered.
FDA’s guidance applies the hold to nonrenewal too, with prior notice as its main tool for checking that foreign facilities offering food are registered. Registration comes before entry, as our guide to importing human food explains. Each deadline below runs in calendar days, as the hold rule counts them at 21 CFR 1.285.
- The food stays within the port of entry unless CBP or FDA directs otherwise, or it is exported at once with CBP concurrence. It is treated as general order merchandise.
- Within 5 days of the hold, the carrier, submitter, importer, owner or ultimate consignee may ask FDA to review whether the facility must register. FDA answers within 5 days, and the request cannot be used to obtain a registration number.
- Within 30 days of the hold notice, or of FDA’s answer to a review request, a valid registration number must reach FDA’s Division of Food Defense Targeting.
- Without a registration, a review request or export, the food may only be sold for export or destroyed, unless CBP and FDA agree otherwise.
A final rule set the 30-day deadline from October 27, 2025. Neither FDA nor CBP is liable for a hold’s costs. Release from the hold does not mean the food will be admitted under other provisions of the law.
Only food from foreign facilities faces this hold. Whether the facility must register comes first, and the carrier, submitter, importer, owner or ultimate consignee may ask FDA within 5 calendar days. The 30 days for a valid number run from the hold notice or from FDA’s answer.
Protecting Your FDA Food Facility Registration Number and PIN
Third-party seller platforms have been asking food companies for a copy of their registration or a certificate, according to FDA’s July 2026 update. Some third-party “registrars” have asked for the number and PIN, or the login itself. With the number and PIN, an outside party can link the registration to its own account and view, change or even cancel it.
Registration information is not public. FDA does not require sharing the number with third parties, apart from imports, where the company filing prior notice may need it. There is no FDA certificate of registration either, and none issued by a private business is recognized. A registration number does not mean FDA approves or endorses the facility or its products.
Keep the FIS-FURLS username and password to yourself, as FDA advises, and give staff who help manage registrations their own subaccounts. If the number or PIN already went out in error, FDA suggests considering canceling and re-registering. It also asks that suspected misuse be reported.
For a foreign facility, FDA’s 2018 guidance says a canceled registration ends the U.S. agent’s role. Any new filing names an agent who must agree again. A facility that only lost its FURLS login or PIN should contact FDA rather than register again.
Questions About FDA Food Facility Registration
How much does it cost to register a food facility with the FDA?
Registration and renewal carry no FDA fee. A U.S. agent may charge for its services, which FDA leaves to the facility and the agent to decide. FDA’s 2018 guidance called the DUNS number free of charge, so check Dun & Bradstreet’s current terms.
How can I look up a food facility registration number?
Registration numbers are not published. The list of registered facilities and the registration documents are exempt from Freedom of Information Act disclosure. The public identifier is the separate FEI number, searchable in FDA’s FEI Search Portal.
Will an FDA investigator check our registration during an inspection?
Under FDA’s nonbinding Compliance Policy Guide 100.250, an investigator at a domestic facility should check whether it is registered and its information accurate and current. A problem found should lead the investigator to advise management of the duty to register or update. An Untitled Letter may follow for a nonexempt facility once the file shows that advice and the office has verified it is still unregistered.
Is our U.S. agent liable for FDA reinspection fees?
Yes, for a foreign facility, after an inspection finds noncompliance tied to a food safety requirement. The rate for fiscal 2027 is $325 an hour. Foreign inspection travel raises that to $414, though FDA does not intend to invoice until it publishes guidance on requesting fee reductions.
Do qualified facilities file anything else this renewal season?
Yes, an attestation, due by December 31, 2026, on Form FDA 3942a for human food or 3942b for animal food. Filing it requires a valid registration. Separately, 21 CFR 117.201(c)(1) or 507.7(c)(1) requires each facility to work out and record its status by July 1 every year.
Do we have to use a registration service or registrar?
No. Registrants need not use a third-party business or registrar for FDA registration. FDA has also said it is not affiliated with these private businesses, which do not act on its behalf.
Talk With OFW Law About a Registration Problem
I am J. Mason Weeda, Managing Principal at OFW Law and Chair of its FDA Food Practice and Digital Health Practice. A renewal with a matching identifier and a consenting agent is a filing the facility or its agent can make without a lawyer.
Legal judgment helps when an exemption is unclear, or when a registration has lapsed or been canceled. It helps as well when a platform or registrar asks for credentials, or when a shipment is held at the port. In any of those situations, contact our team.
