What Happens If Your FDA Food Facility Registration Expires? (2026)

If a food facility registration is not renewed during FDA’s biennial renewal window — October 1 through December 31 of each even-numbered year — it expires, and FDA cancels expired registrations. Failure to register or renew when required is a prohibited act under 21 CFR 1.241, and the facility no longer holds an active FDA registration.

When does an FDA food facility registration expire?

The renewal rule is 21 CFR 1.230(b): “You must submit a registration renewal containing the information required under § 1.232 every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year.” 2026 is an even-numbered year, so the current window runs from October 1 to December 31, 2026. A registration that is not renewed inside that window expires. Our 2026 renewal guide walks through the renewal itself step by step.

What does FDA do with an expired registration?

FDA cancels expired registrations. Under 21 CFR 1.241, failing to register or renew a facility when required is a prohibited act under section 301(dd) of the Federal Food, Drug, and Cosmetic Act. FDA’s biennial registration fact sheet states it plainly: FDA “will cancel a registration if the facility’s registration has expired because the facility has failed to renew its registration as required.”

How do you fix an expired FDA food facility registration?

A facility that missed the window registers again through FDA’s FURLS system, submitting the information required by 21 CFR 1.232, including a unique facility identifier (UFI) recognized as acceptable by FDA — currently a DUNS number. For a foreign facility, the registration must identify a U.S. Agent — name, address, phone and email under 21 CFR 1.232(c)(1) — and the agent must confirm agreement to serve. Our food facility registration service handles recovery filings for lapsed registrations.

Do foreign facilities need a U.S. Agent to renew?

Yes. The U.S. Agent requirement applies only to foreign facilities. Under 21 CFR 1.227 the agent must reside or maintain a place of business in the United States and may not be a mailbox or an answering service. Domestic facilities renew on the same biennial schedule but do not designate a U.S. Agent.

How do you avoid an expiry in 2026?

Renew inside the window. If nothing has changed since the last registration, 21 CFR 1.230(c) provides an abbreviated renewal process using Form FDA 3537. FDA itself charges nothing — 21 CFR 1.231(c) states “No registration fee is required.” Any fee paid to a service provider is a professional service fee, not a government charge; current service pricing is published on our pricing page. Not sure where your registration stands? Use our free Verify FDA Registration check.

Frequently asked questions

Does FDA charge a fee to renew a food facility registration?

No. 21 CFR 1.231(c) states that no registration fee is required. Any fee you pay is a professional service fee to the firm handling the filing, not a government charge.

Is the renewal deadline the same for domestic and foreign facilities?

Yes — every registered facility renews between October 1 and December 31 of each even-numbered year. The difference is the U.S. Agent requirement, which applies only to foreign facilities.

Is drug establishment registration on the same cycle?

No. Drug establishments review and update their registration information annually, between October 1 and December 31 of each year, under 21 CFR 207.29 — an annual review-and-update cycle, not a biennial renewal.

Can you renew after December 31, 2026?

The renewal period ends on December 31, and a registration not renewed in the window expires — FDA cancels a registration that has expired because the facility failed to renew. To restore compliance, the facility submits its registration information under 21 CFR 1.232 again through FURLS.

Axentra Global Pharma Compliance LLC (Albuquerque, New Mexico) serves as U.S. Agent and handles FDA food facility registrations, renewals and recovery filings for foreign and domestic facilities. Call +1 505 358 4858 or email info@axentracompliance.com — or start with our U.S. Agent service and pricing page.