FDA Import Alert 99-41: How Importers Land on the FSVP Red List and Get Off It

Import Alert 99-41 is FDA's alert for importers who appear not to be complying with the FSVP rule. Firms named on it are said to be on the "Red List". Once an importer is listed for a food, FDA divisions may detain that food without physical examination (DWPE) when that importer offers it for entry. FDA revised the alert most recently on 3 November 2026, according to the published date on the alert page.

This guide is for UK and other overseas food and supplement businesses that ship to the US. It explains how an importer ends up on the Red List, what it does to your shipments, and how the importer gets off it.

What Is Import Alert 99-41?

Section 805 of the Federal Food, Drug, and Cosmetic Act requires each importer of food to carry out risk-based verification that the food it imports is produced to US safety standards and is not adulterated or misbranded for allergen labelling. FDA's rule putting this into practice is the FSVP regulation in 21 CFR Part 1, Subpart L.

Under 21 CFR 1.514(a), a food can be refused admission under section 801(a)(3) of the Act if it appears that the importer is not complying with the FSVP rule for that food. Import Alert 99-41 is how FDA applies that at the border. Its charge reads: "The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805."

The "importer" here is the FSVP importer: the US owner or consignee at entry, or, if there isn't one, the US agent or representative the foreign owner has designated in a signed statement of consent. The alert notes that the FSVP importer may or may not also be the importer of record.

How Does an Importer End Up on the Red List?

The alert says an importer may be added "because it appears that the importer is not in compliance with FSVP requirements for one or more foods". FDA divisions send recommendations to the Human Foods Program (for human food) or the Center for Veterinary Medicine (for animal food), which decide whether DWPE is warranted. The alert's removal section refers to "the regulatory letter notifying the importer of their FSVP violations and placement on import alert #99-41", so the importer is told in writing.

In practice, problems come to light when FDA reviews an importer's FSVP. Importers must make their FSVP records available to FDA promptly on request, and records kept offsite must be retrievable within 24 hours. The gaps that matter are the core FSVP duties:

• ✓ No written FSVP at all for a food the importer brings in (21 CFR 1.502).
• ✓ No written hazard analysis for each type of food, which must be written whatever its outcome (21 CFR 1.504).
• ✓ No documented evaluation and approval of the foreign supplier (21 CFR 1.505 and 1.506).
• ✓ No verification activities, such as audits, sampling and testing, or record reviews, matched to the hazards (21 CFR 1.506).
• ✓ No corrective action when the importer learns a supplier's food is not compliant (21 CFR 1.508).
• ✓ Records that can't be produced, or aren't signed, dated and kept for at least two years (21 CFR 1.510).

Importing food without an FSVP that meets section 805 is also a prohibited act under section 301(zz) of the Act (21 CFR 1.514(b)).

What Happens to Shipments Once an Importer Is Listed?

The alert lets FDA divisions detain without physical examination "an article of human or animal food offered for import by an importer identified on the Red List of this import alert, for the food identified on the Red List." In other words, the shipment can be held at entry on the strength of the listing alone.

The scope depends on the listing. The Red List may name specific foods from a specific foreign supplier. But the alert also says that, in some cases, "an importer may be subject to DWPE for all food that the importer imports" where it appears the importer is in violation for all foods. On the live Red List, some entries carry the note "All Imported Products Subject to the FSVP Regulation".

The alert does not apply to foods that are exempt from FSVP under 21 CFR 1.501, including juice and seafood covered by FDA's HACCP rules, food for research or evaluation, food for personal consumption, alcoholic beverages, food transshipped or imported for processing and export, US food returned, and certain meat, poultry and egg products.

What Does It Mean for an Overseas Supplier?

This is the part that surprises exporters. FDA states plainly: "Even when an importer is not in compliance with FSVP requirements, the food and/or foreign supplier may nevertheless be in compliance with applicable requirements." Your name can appear on the Red List as the foreign supplier, yet the alert "does not apply to all food produced by the foreign supplier". The only food caught is "the specified food when imported by the identified importer (but not when imported by other importers)."

So your products are not banned from the US. But any shipment going through that importer is at risk until it is removed. And FDA is clear that the supplier can't fix this alone: "the foreign supplier is not responsible for demonstrating that the conditions that gave rise to the appearance of the violations have been resolved." If a foreign supplier contacts FDA about removal, FDA offices are told to direct it back to the importer.

• ✓ Ask your US importer directly whether it has received an FSVP regulatory letter or been placed on Import Alert 99-41.
• ✓ Pause new shipments through that importer for the listed food until the position is clear, or until it has been removed.
• ✓ Help the importer rebuild its FSVP by sending current specifications, food safety plans, audit reports, test results and allergen labelling evidence.
• ✓ Check who is named as the FSVP importer on each entry. If there is no US owner or consignee, you must designate a US agent or representative as the FSVP importer before the food is imported (21 CFR 1.509(b)).

How Does an Importer Get Removed From the Red List?

The alert sets out the route. The importer, or someone acting for it, should send information supporting its request to the FDA Compliance Officer or office that issued the regulatory letter. The submission should "adequately demonstrate that the importer has resolved the conditions that gave rise to the appearance of the FSVP violation", may include information on each violation described in the letter, and must be in English. Its purpose, in FDA's words, is to give "assurance that the importer is meeting the requirements of FSVP for future entries of the food from the foreign supplier."

• ✓ Answer every violation in the regulatory letter, point by point.
• ✓ Show the corrected FSVP: hazard analyses, supplier evaluations and approvals, verification activities and corrective action procedures, signed and dated.
• ✓ Show it working, with completed verification records for the foreign supplier and food named on the Red List.
• ✓ Be ready for a follow-up inspection. The alert says FDA may inspect the importer again, as appropriate, to decide whether the violation has been overcome.
• ✓ Apply before shipping. FDA divisions are told to encourage importers to request removal before they try to import the listed food again.

If the evidence is accepted, the division may recommend removal to FDA's Division of Import Operations, which consults the relevant Center and division. For the wider removal process, see our guide on how to remove an FDA import alert, and our Import Alerts 101 on searching the alert lists. Our post on common FSVP mistakes exporters make covers how to avoid problems in the first place.

Frequently Asked Questions

Is the Red List the same as being banned from the US?
No. Import Alert 99-41 lists importers. A listed food can be detained without examination when that importer offers it for entry, but FDA says the same food is not covered when imported by other importers.

Can a foreign supplier get an importer removed from the list?
No. FDA says the foreign supplier is not responsible for showing the violations have been resolved and will direct suppliers to the importer. The supplier can help by providing the documents the importer needs.

Does Import Alert 99-41 cover seafood and juice?
No. Foods exempt from FSVP under 21 CFR 1.501 are outside the alert, including juice and seafood covered by FDA's HACCP regulations, provided the conditions of that exemption are met.

Who is the "importer" for FSVP purposes?
The US owner or consignee at the time of entry. If there isn't one, it is the US agent or representative designated by the foreign owner or consignee, confirmed in a signed statement of consent. This may differ from the importer of record.

Can a listed importer keep shipping while it asks for removal?
Its listed food remains subject to DWPE until FDA removes it. FDA encourages importers to request removal before trying to import that food again.

How Global Import Agent Helps

• ✓ FSVP importer and US agent services for overseas suppliers without a US owner or consignee at entry.
• ✓ FSVP gap reviews of hazard analyses, supplier approvals, verification activities and records against 21 CFR Part 1, Subpart L.
• ✓ Supplier document packs that give your US importers the evidence they need for their FSVP.
• ✓ Import alert removal support, including preparing a structured response to an FSVP regulatory letter.

Disclaimer: This article is general information, not legal advice, and reflects FDA Import Alert 99-41 as published on 3 November 2026 and 21 CFR Part 1, Subpart L as checked on 4 November 2026. Global Import Agent LLC is a private compliance services company and is not affiliated with, endorsed by, or acting on behalf of the US Food and Drug Administration or any other government agency. Always check the current import alert and regulations before acting.