FDA Registration Cancellation, Expiration and Suspension: Three Different Things

When people say FDA registration cancellation, most companies mean a single situation, but there are actually three distinct statuses. The facility itself can cancel its registration, the registration ends on its own when the renewal is not completed, and FDA can suspend a registration under a separate authority. The cause and the outcome differ in each case.

The difference matters in practice, because the path back to an active registration is different for each one. If a renewal is missed, a new registration is usually possible. A suspended registration, on the other hand, is tied to a separate procedure handled with FDA.

Below, we first separate the three statuses, then look at how each one affects shipments and how re-registration works. Wherever we give a figure or a deadline, we also cite its source.

What is the difference between FDA registration cancellation, expiration and suspension?

In short: cancellation happens at the facility's own request, expiration happens automatically when the biennial renewal is not completed, and suspension happens through an order issued by FDA. The first two are administrative situations; the third is an action FDA takes when it sees a serious potential concern related to food.

When do you need to cancel a registration?

Under 21 CFR 1.235, a registration should be cancelled within 60 calendar days of the reason for cancellation arising. The regulation gives three examples: the facility ceases operations, the facility stops shipping food to the U.S., or the facility is transferred to a new owner. Since January 4, 2020, cancellation has been done electronically; mail or fax remains an option only if FDA has granted a waiver.

A change of ownership is the most frequently overlooked case. When a facility changes hands, the old registration should be closed and a new registration opened in the new owner's name. If the old registration stays open, the system shows an active registration for a business that no longer exists.

Failing to meet the registration, renewal, update and cancellation requirements is a prohibited act under section 301(dd) of the FD&C Act. In other words, cancelling is a more appropriate way to close out a registration than leaving it open.

What happens to the registration if I miss the renewal?

If the renewal is not completed by December 31 of an even-numbered year, the registration is considered expired and FDA treats the facility as not having met its registration requirement. Since 2026 is an even year, the window runs from October 1 to December 31, 2026. The process and a checklist are laid out step by step in our FDA registration renewal guide.

This is different from cancellation: the facility takes no action, and the registration ends because of the calendar. On the shipment side, however, the result is similar to cancellation, because in both cases the facility does not appear as registered.

What happens to food from an unregistered facility?

If a foreign facility that is required to register is not registered, food from that facility that is imported or offered for import into the U.S. is held at the port of entry and is not delivered to the importer, owner or consignee until the facility completes its facility registration. The registration can be completed afterwards, but the time that passes in the meantime comes back to the company as storage and holding costs.

The rule published in the Federal Register on September 25, 2025 (90 FR 46045), effective October 27, 2025, added a time limit here. When a shipment is held because the facility is not registered, the registration must be submitted within 30 calendar days. The same rule also set a 10-day window for submitting Prior Notice after a refused or held shipment. You can find the details in our Prior Notice guide.

Even with a complete registration, a shipment can still be selected for examination. Registration does not guarantee entry; label compliance and the inspection at the port of entry remain separate matters. Our article I have an FDA registration, so why is my product held at customs explains this in detail.

When does FDA suspend a registration?

Section 415(b) of the FD&C Act authorizes FDA to suspend a registration when food manufactured, processed, packed or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals. This authority applies when the facility created, caused or was responsible for that situation, or knew or should have known about it.

When a suspension order is issued, the registrant is given the opportunity for an informal hearing. The hearing is held as soon as possible and no later than 2 business days after the order is issued, unless the parties agree on a different timeframe. It covers the actions required for reinstatement of the registration and why the suspension should be lifted.

While a suspension is in effect, under 415(b)(4) no person may import or export food from that facility into the United States, offer it for import or export, or otherwise introduce it into commerce within the United States. If FDA determines, based on the evidence presented, that there are not adequate grounds to continue the suspension, it reinstates the registration.

This third status should not be discussed alongside the first two. Cancellation and expiration are administrative matters, while suspension is a separate legal process.

How can you check your registration status?

Registration status is shown in the FURLS account used for the registration. FDA does not publish facility registrations in a public database anyone can search, so the way to check your status is to log in to your own account. If the account credentials are lost, recovering them comes first, because both renewal and cancellation are done through the same account.

FDA also warns about one point here: third parties that offer to verify your registration status by asking for your registration number, PIN and FURLS login details are not acting on behalf of FDA. FDA recommends keeping this information protected. Since registration and renewal are free of charge, it may make sense to step back when someone asks for payment in exchange for verification.

Logging in once a year to check the registration status, the US Agent field and the product categories is a simple habit that catches all three issues early. Doing this check in September, especially ahead of even-numbered years, eases the December rush.

How does re-registration work?

For a facility whose registration has been cancelled or has expired, the path is a new registration. The process works the same way as the first registration: facility details, product categories, the D-U-N-S number as the unique facility identifier and, for foreign facilities, US Agent information are entered. Then the agent's confirmation is awaited.

We explain the agent confirmation mechanism and the steps for changing agents in detail in our FDA US Agent guide. Since the new registration number may differ from the old one, records on the importer and customs broker side also need to be updated.

Frequently asked questions

If my FDA registration is cancelled, can I register again?

Yes. A new registration is opened for a cancelled or expired registration, and the process works the same as the first registration. US Agent confirmation is required again, so keeping the agent information current speeds things up.

If my registration expired, do I get my old number back?

An expired registration requires a new registration, which usually means a new registration number. If the old number remains on shipping documents or in the importer's records, it needs to be updated.

I sold my facility. What should I do with the registration?

A change of ownership is listed as a reason for cancellation in 21 CFR 1.235, and cancellation is expected within 60 calendar days of the reason arising. The new owner opens a new registration in its own name. Leaving the old registration open keeps an active registration in the name of a business that no longer exists.

I have temporarily stopped shipping to the U.S. Should I cancel the registration?

Ceasing to ship food to the United States is listed among the reasons for cancellation in the regulation. However, if you plan to resume soon, keeping the registration open and renewing it every two years may be more practical. The decision depends on how long the break will last.

Is a suspended registration reinstated automatically?

No. A suspension ends when FDA reinstates the registration. FDA makes this decision when it determines, based on the evidence presented, that there are not adequate grounds to continue the suspension.

Conclusion

Cancellation, expiration and suspension of an FDA registration are three different statuses. The first is done at the facility's own request within 60 calendar days, the second happens automatically on December 31 of an even-numbered year, and the third results from an FDA order and follows a separate procedure.

In the first two cases, the path is a new registration, and that process still depends on U.S. Agent confirmation. The most practical precaution is not to miss the 2026 renewal window. Rules can change, so it makes sense to confirm on fda.gov before taking action.

To check your registration status, re-register or renew, you can contact us through our FDA registration and certification service.