Import Alert 99-41: What It Means for Foreign Food Facilities

What Is Import Alert 99-41?

Import Alert 99-41, titled "Detention Without Physical Examination of Food Products From Unregistered Food Facilities", is an FDA enforcement tool that allows U.S. port officials to automatically detain food shipments from foreign facilities that have not completed the required FDA food facility registration under 21 CFR Part 1, Subpart H.

Under Section 415 of the FD&C Act, as amended by the Bioterrorism Act of 2002 and FSMA, every foreign facility that manufactures, processes, packs, or holds food intended for U.S. consumption must register with FDA. The registration must be current (renewed biennially during even-numbered years), and the facility must have a designated U.S. Agent.

When FDA determines that a facility's registration is not current — either because the facility never registered, failed to renew during the biennial period, or has an incomplete registration (such as a missing U.S. Agent) — the facility can be placed on Import Alert 99-41. Once on the alert, all food products from that facility are subject to DWPE, regardless of the specific product type.

IA 99-41 is one of the most common Import Alerts affecting foreign food facilities. FDA maintains a public "red list" of firms currently on the alert, searchable through FDA's Import Alert database.

How Do Facilities End Up on IA 99-41?

There are several common scenarios that lead to placement on Import Alert 99-41:

• Never registered — the facility has never submitted a food facility registration to FDA. This is common for new exporters who are unaware of the U.S. registration requirement.
• Failed to renew — the facility registered in a previous biennial cycle but did not renew during the most recent renewal period (October 1 – December 31 of even-numbered years). For example, a facility that registered in 2022 but did not renew in 2024 would have an expired registration.
• Registration suspended — FDA has the authority under Section 415(b) (added by FSMA) to suspend a facility's registration if there is a reasonable probability that food from the facility will cause serious adverse health consequences. A suspended registration effectively removes the facility from the system.
• Missing or invalid U.S. Agent — if the designated U.S. Agent is no longer valid (e.g., the agent resigned, the contact information is outdated, or no agent was ever designated), the registration may be deemed incomplete.
• Prior Notice discrepancy — when a Prior Notice filing references a foreign facility that is not in FDA's registration database, the shipment can be flagged, and the facility may be investigated for registration compliance.

Consequences of Being on Import Alert 99-41

Being placed on IA 99-41 has immediate and severe consequences for your U.S. export business:

• Automatic detention — every food shipment from your facility will be detained at the U.S. port of entry without physical examination. The detention notice is issued to the importer, who must respond or the goods will be refused admission.
• No selective targeting — unlike some Import Alerts that target specific products or hazards, IA 99-41 applies to all food products from the unregistered facility.
• Financial losses — detained shipments incur storage fees, demurrage charges, and potential destruction costs. The importer bears these costs, which can strain business relationships.
• Reputational damage — U.S. importers and buyers will see your facility on FDA's public alert list. Many will refuse to do business with a facility on an Import Alert.
• Cascading compliance issues — a detention due to registration issues may trigger additional scrutiny of the facility's products, leading to further investigations.

The good news is that IA 99-41 is one of the more straightforward Import Alerts to resolve, because the underlying issue — registration — is correctable without the extensive evidence gathering required for alerts related to contamination or adulteration.

How to Get Off Import Alert 99-41

Removal from IA 99-41 requires correcting the underlying registration deficiency and then requesting that FDA remove your facility from the alert. The process generally follows these steps:

1. Identify the registration issue — determine whether your facility (a) never registered, (b) failed to renew, (c) has an invalid U.S. Agent, or (d) had its registration suspended. Each scenario requires a slightly different corrective approach.
2. Complete or correct your FDA registration — register (or re-register) through the FDA Food Facility Registration Module (FFRM) at access.fda.gov. Ensure all required fields are completed, including your U.S. Agent designation.
3. Designate a valid U.S. Agent — if your U.S. Agent was missing or invalid, appoint a new one. Assurentry provides same-day U.S. Agent designation letters.
4. Obtain your registration confirmation — after successful registration, FDA assigns (or reconfirms) your facility's registration number. Keep a copy of the confirmation.
5. Contact FDA's Division of Import Operations — notify FDA that your registration has been corrected and request removal from IA 99-41. Provide your registration number, facility name, FEI number, and U.S. Agent information.
6. Wait for processing — FDA typically processes removal requests within a few weeks, though timing varies. Your importer can track the status through FDA's import system.

Once FDA verifies that your registration is current and complete, your facility will be removed from the IA 99-41 red list, and shipments will no longer be automatically detained (though they may still be subject to normal import examination).

The Role of Your U.S. Agent in Resolving IA 99-41

Your U.S. Agent plays a critical role in both preventing and resolving Import Alert 99-41 issues:

• Prevention — a competent U.S. Agent monitors your registration status, reminds you of biennial renewal deadlines, and ensures that the registration remains active. Assurentry proactively notifies clients well before renewal windows open.
• Communication — if FDA issues a detention notice or places your facility on an Import Alert, the U.S. Agent is the designated contact. A responsive U.S. Agent can facilitate faster communication between your facility and FDA.
• Corrective assistance — your U.S. Agent can help identify the specific registration deficiency and guide you through the correction process. This is particularly valuable for facilities that are unfamiliar with FDA's electronic systems.
• Importer coordination — the U.S. Agent can communicate with the importer of record, customs broker, and FDA to coordinate the resolution process and minimize delays.

Choosing a reliable U.S. Agent who actively monitors your registration status is one of the most effective ways to avoid IA 99-41 entirely. Unlike some agents that simply provide a name and address, Assurentry provides proactive registration monitoring and renewal reminders as part of the standard service.

Preventing Future Issues: Registration Best Practices

To avoid ending up on Import Alert 99-41 in the future, follow these best practices:

• Calendar your biennial renewal — the renewal window runs October 1 – December 31 of even-numbered years (2024, 2026, 2028, etc.). Set reminders well in advance. See our 2026 biennial renewal guide for details.
• Verify your U.S. Agent annually — confirm that your designated U.S. Agent is still active and that the contact information on file with FDA is current.
• Update registration for any changes — if your facility name, address, ownership, or operational activities change, update your FDA registration within 60 days. Stale information can cause complications.
• Maintain Prior Notice accuracy — ensure that the facility information in Prior Notice filings matches your FDA registration. Discrepancies can trigger investigations.
• Work with a professional U.S. Agent — a dedicated U.S. Agent provider like Assurentry handles registration monitoring, renewal reminders, and FDA communications, reducing the risk of compliance lapses.