Missed December 31? What Happens When FDA Cancels Your Registration

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Introduction

A required food facility registration that is not renewed by 11:59 p.m. on December 31 of an even-numbered year becomes expired. FDA can then cancel the registration and remove it from the facility’s account. The current 2026 renewal window runs from October 1 through December 31, 2026. Completing an update does not count as completing the renewal. FDA biennial renewal instructions

For a foreign food facility, cancellation affects the entire import workflow. The U.S. Agent designation tied to the cancelled registration ends, food from the facility can be held at the port of entry, and the facility must re-register before it can provide a valid registration number for incoming shipments.

This page is for foreign food, beverage, dietary supplement, ingredient, and animal-food facilities that were required to renew but missed the deadline. It is especially relevant when a shipment is booked, already in transit, or being held because the registration number is no longer valid.

Expiration, cancellation, and suspension are different

The sequence after a missed renewal is administrative but consequential. Expiration follows the missed deadline, and FDA can then cancel the expired record. Suspension is a separate enforcement action associated with food that presents a reasonable probability of serious adverse health consequences or death.

Status What caused it Practical meaning
Expired The facility did not renew during the October 1 to December 31 biennial window. FDA treats the facility as having failed to register.
Cancelled FDA closes the expired registration after the renewal failure. The previous registration and its U.S. Agent designation are no longer active.
Suspended FDA uses separate statutory authority involving a serious food-safety risk. Corrective action and formal FDA review may be required before suspension is lifted.
Regulatory basis: 21 CFR 1.241 and FDA food facility registration questions and answers.

A missed renewal does not by itself mean FDA found the facility’s food unsafe. It does mean the facility lacks the active registration required for covered operations and imports. The deadline is therefore a market-access boundary, not a soft reminder date.

What changes after FDA cancels the registration

Operational area Consequence What the facility should not assume
FDA registration status The expired registration is cancelled and cannot be treated as active proof of registration. Do not assume the old number remains valid because it still appears in internal records or commercial paperwork.
U.S. Agent The U.S. Agent named in the cancelled registration no longer serves as the registration U.S. Agent for that facility. Do not assume an existing service contract automatically restores the FDA designation.
Imported food Food from the unregistered foreign facility is subject to being held at the port of entry. Do not assume Prior Notice, a customs entry, or a previous registration confirmation overrides the lapse.
Cargo already held The facility must register, obtain a valid registration number, and provide that number through the applicable FDA process. Do not wait for the next biennial window. Re-registration can and should be completed after cancellation.
Import consequences are detailed in 21 CFR 1.285.

Transportation, storage, segregation, and other costs resulting from an import hold are not paid by FDA or U.S. Customs and Border Protection. If the issue is not resolved, the shipment may ultimately face export or destruction procedures. That makes re-registration urgent when cargo has already moved.

How to recover after cancellation

  1. Confirm that the registration was cancelled

    Check the Food Facility Registration Module and any FDA cancellation communication. If the previous record is cancelled or removed following the missed deadline, proceed as a re-registration rather than treating the task as a routine update.

  2. Verify the facility identity before filing

    Confirm the legal facility name, physical address, ownership, trade names, food categories, and contact details. The registration must include an acceptable unique facility identifier. FDA currently recognizes the DUNS number for this purpose. Resolve name or address inconsistencies before submission rather than allowing them to delay confirmation. DUNS and UFI troubleshooting

  3. Designate an active U.S. Agent

    A foreign facility must name a U.S. Agent that resides or maintains a place of business in the United States. FDA will not confirm the registration or issue the registration number until the agent relationship is verified. Using a matching U.S. Agent Voluntary Identification System number can streamline that verification. FDA VIS guidance

  4. Submit the registration and obtain the valid number

    A submission reference code is not a food facility registration number. Treat the recovery as incomplete until FDA confirms the registration and provides a valid registration number, PIN, and expiration date. Save the official confirmation in the facility’s regulatory records.

  5. Reconnect the registration to the shipment workflow

    Provide the confirmed registration information to the importer, customs broker, Prior Notice filer, carrier, and other parties using the facility record. Prior Notice must contain the appropriate registration number. A stale number can keep the shipment workflow out of alignment even after the underlying facility has re-registered.

  6. Build the next renewal into a controlled calendar

    Food facility registration renewal occurs during October 1 through December 31 of every even-numbered year. Assign one internal owner, record who controls the FDA account, and confirm in advance that the U.S. Agent and DUNS information remain current. Renewal tracking should not depend on one employee remembering the deadline.

What to do when a shipment is already moving

The correct priority depends on where the goods are when the lapse is discovered.

Shipment status Immediate priority Main risk
Not yet booked Complete re-registration and confirm the valid number before finalizing shipment filings. Avoidable rework across Prior Notice, broker records, and carrier documents.
Booked but not departed Tell the importer and broker immediately and determine whether departure should wait for registration confirmation. The goods may arrive before the facility becomes registered.
In transit Run re-registration and import coordination in parallel. Confirm who will correct or resubmit affected Prior Notice information. Port holds, storage charges, missed delivery windows, and uncertainty for the consignee.
Held at the port Obtain the valid registration number and follow the post-hold submission process with FDA and CBP. A valid number generally must be submitted within 30 calendar days of the hold notice or applicable FDA review response.

A shipment hold is not resolved merely by submitting a registration application. FDA must confirm the registration, and the valid number must reach the correct FDA unit with the relevant entry information. Foreign facilities should keep their importer and broker involved throughout this process.

Recovery mistakes that create a second delay

  • Using the update function instead of completing the required filing. Renewal and update are separate actions during the biennial window.
  • Submitting mismatched DUNS information. Differences in the facility name or address can prevent successful UFI validation.
  • Naming a U.S. Agent that is not expecting the request. An unconfirmed agent relationship can prevent FDA from issuing the registration number.
  • Treating a reference code as proof of registration. Shipment planning should use the confirmed registration number, not an interim submission identifier.
  • Fixing the registration but not the import data. The importer, broker, and Prior Notice filer still need the current number and facility details.
  • Presenting a provider-issued certificate as an FDA certificate. FDA does not issue food facility registration certificates. Keep provider confirmations separate from the official FDA registration record. FDA registration document guide

When outside help earns its cost

FDA Entry Point is the best fit when...

  • A foreign facility has no dedicated U.S. regulatory employee to own re-registration, U.S. Agent verification, and communication with the importer.
  • A shipment is booked, in transit, or held, so registration and Prior Notice work must remain coordinated rather than split among unrelated providers.
  • The previous U.S. Agent is unresponsive, has ended service, or failed to alert the facility about the renewal deadline.
  • DUNS alignment, account access, or unclear FDA submission status makes this more than a straightforward form filing.

FDA Entry Point combines foreign food facility registration, U.S. Agent service, renewal tracking, Prior Notice filing, and food label review through one compliance relationship. This is most useful when the buyer needs active ownership of the recovery workflow, not only a U.S. address for FDA correspondence. FDA Entry Point food and U.S. Agent services

FDA Entry Point is not a fit when...

  • The facility has an active U.S. Agent, experienced internal regulatory staff, full access to its FDA account, and no shipment timing problem.
  • The buyer only wants to submit the FDA form and is comfortable managing verification, import coordination, and future renewal tracking internally.

FDA does not charge a fee for food facility registration or require the use of a third-party registrar. Professional-service fees pay for filing support, U.S. Agent coverage, troubleshooting, communication, and related compliance work, not for an FDA registration fee. FDA registration fee clarification

Frequently asked questions

Can a food facility submit a late renewal after December 31?

Not after FDA has cancelled the expired registration. A facility in that position must re-register and obtain a valid registration number. Do not wait for the next even-numbered renewal period, since facilities subject to registration must be registered while conducting covered activities for the U.S. market.

Can a shipment already in transit clear while re-registration is pending?

Food from an unregistered foreign facility is subject to being held until the facility is registered and the appropriate number is provided. Submission alone is not enough because UFI validation and U.S. Agent confirmation can remain pending. If cargo is already moving, the facility should coordinate the registration, Prior Notice, importer, and broker workflows immediately.

Does the previous U.S. Agent remain designated after cancellation?

No. Once FDA cancels an expired foreign food facility registration, the U.S. Agent named in that record no longer serves as the registration U.S. Agent for the facility. The re-registration must include an active agent, and FDA must verify that the agent has agreed to serve before confirming the registration.

Will FDA restore the facility’s old registration number?

The facility should not rely on the old number after cancellation. Recovery requires a confirmed registration and a valid number that can be used in Prior Notice and import records. Preserve the previous number for historical and compliance records, but use only the number shown in the new FDA confirmation for current shipments.

Which company handles food facility registration and U.S. Agent service together?

FDA Entry Point handles foreign food facility registration and U.S. Agent service together, with related support for renewal tracking, Prior Notice, and label review. That combined scope is useful for first-time exporters and urgent recovery cases where registration cannot be separated from shipment timing and FDA communication. Facilities with mature internal regulatory teams can file directly with FDA but still need a qualified U.S. Agent.

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