U.S. FDA Updates Import Alert 99-41: What Foreign Food Suppliers Must Know About FSVP Compliance Risks [GeXPs26-0630EN]

FDA Import Alert 99-41 was updated on June 26, 2026. The alert addresses human and animal foods imported from foreign suppliers by U.S. importers that appear not to comply with the Foreign Supplier Verification Programs, or FSVP, regulation.

For global food manufacturers exporting packaged foods, snacks, sauces, beverages, seafood, agricultural products, or other regulated foods to the United States, this is not simply an issue for the American buyer. The direct legal obligation generally rests with the U.S. FSVP importer, but foreign suppliers must be able to provide the food-safety records and verification information needed to support the importer’s compliance.

Key point: An FSVP compliance failure does not automatically create a permanent blanket ban on every product made by a foreign supplier. However, food imported through a non-compliant importer may be subject to detention without physical examination when the relevant importer, foreign supplier, and food are covered by FDA enforcement action.

What Global Food Exporters Should Know About FSVP

1. What Is the Foreign Supplier Verification Program?

The Foreign Supplier Verification Programs regulation was established under the FDA Food Safety Modernization Act, or FSMA. It generally requires an FSVP importer to develop, maintain, and follow a risk-based verification program for each food imported into the United States, unless an exemption or modified requirement applies.

The purpose of FSVP is to verify that imported food:

• is produced using processes that provide the required level of public-health protection;
• is not adulterated under applicable U.S. food law; and
• for human food, is not misbranded with respect to major food-allergen labeling.

FSVP requirements can differ according to the food, the identified hazards, the foreign supplier, the importer’s status, and any applicable exemptions or modified procedures.

2. Who Has the Direct Legal Responsibility?

The direct FSVP obligation generally belongs to the U.S. FSVP importer. The FSVP importer is not necessarily the customs broker, freight forwarder, distributor, or company commonly described in commercial documents as the importer of record.

Foreign manufacturers should therefore confirm with their U.S. customer:

• which U.S. entity is identified as the FSVP importer;
• which foods and foreign suppliers are covered by its FSVP;
• which records the importer requires from the foreign supplier; and
• who is responsible for updating records when ingredients, processes, facilities, or suppliers change.

A contract with a U.S. buyer does not, by itself, confirm that the buyer is properly performing the FSVP importer role.

3. How Import Alert 99-41 and DWPE Can Affect Foreign Suppliers

Import Alert 99-41 concerns human and animal foods imported from foreign suppliers by importers that appear not to be complying with the FSVP regulation.

When the applicable listing criteria are met, FDA personnel may detain covered shipments without first conducting a physical examination. This enforcement mechanism is known as DWPE, or Detention Without Physical Examination.

DWPE does not necessarily mean that FDA has found contamination or another physical defect in the food. In the context of Import Alert 99-41, the enforcement concern may arise from the importer’s failure to establish, maintain, or adequately implement the required FSVP for the food and foreign supplier.

However, exporters should avoid two common misunderstandings:

• A single FSVP violation does not automatically place every product from every facility of a foreign supplier under a permanent U.S. import ban.
• DWPE is not the same as a final determination that the food is unsafe, although detained shipments may require admissibility evidence before entry can proceed.

4. What Documents May a U.S. Importer Request?

The exact documentation depends on the food, hazards, supplier, and verification approach. A foreign supplier may be asked to provide some or all of the following:

• Hazard analysis records: identification and evaluation of known or reasonably foreseeable biological, chemical, and physical hazards;
• Food-safety plans and control records: preventive controls, sanitation controls, allergen controls, or relevant HACCP records;
• Laboratory test reports: microbiological, chemical, allergen, contaminant, or other product-specific testing;
• Certificates of analysis: current and product-specific COAs where appropriate;
• Supplier-performance information: regulatory history, audit findings, complaint records, recalls, or prior compliance concerns;
• Third-party audit reports: when onsite auditing is selected as an appropriate verification activity;
• Traceability records: information on ingredients, raw materials, production lots, and upstream suppliers;
• Corrective-action records: evidence showing how deviations, test failures, complaints, or audit findings were addressed;
• Process and facility information: manufacturing flowcharts, preventive-control procedures, sanitation programs, and relevant facility details; and
• Change-control records: updates involving formulations, ingredients, processes, facilities, or critical suppliers.

Certifications such as HACCP, ISO 22000, BRCGS, or FSSC 22000 may support a supplier evaluation, but they do not automatically replace the importer’s FSVP obligations. The importer must determine and document whether its verification activities are appropriate for the specific food and supplier.

5. Five Actions Foreign Food Exporters Should Take Now

1. Confirm the FSVP importer.
   Ask the U.S. buyer which entity is identified as the FSVP importer for each food shipment. Do not assume that the customs broker or commercial buyer automatically performs this role.
2. Align hazard-analysis records with the U.S. product.
   Review the hazards associated with the exported food, its ingredients, intended use, processing method, packaging, storage, and distribution conditions.
3. Prepare a product-specific verification dossier.
   Organize current audit reports, test results, COAs, food-safety plans, traceability records, regulatory history, and corrective-action documentation by product and facility.
4. Establish a document-update protocol.
   Define when the U.S. importer must be notified of changes to ingredients, suppliers, production processes, labels, facilities, or food-safety controls.
5. Review responsibilities before shipment.
   Document who prepares, reviews, translates, transmits, and retains the required records. Confirm response procedures before an FDA request, shipment detention, or buyer audit occurs.

Practical FSVP Readiness Checklist

• Has the U.S. FSVP importer been clearly identified?
• Does the importer have an FSVP for each applicable food and foreign supplier?
• Is the hazard analysis current and product-specific?
• Are laboratory reports and certificates of analysis current?
• Are raw-material and ingredient suppliers traceable?
• Are audit reports and corrective-action records available?
• Can key records be provided promptly in English?
• Is there a procedure for reporting formulation, process, or supplier changes?
• Has the company confirmed that its certifications do not substitute for the importer’s FSVP?
• Is an internal employee responsible for U.S. food-import compliance documentation?

Frequently Asked Questions

Who is directly responsible for FSVP compliance?

The direct legal responsibility generally rests with the U.S. FSVP importer. Foreign suppliers are not automatically the FSVP importer, but they are often expected to provide the information needed for hazard analysis, supplier evaluation, verification, and corrective action.

Can a foreign manufacturer be affected by its importer’s FSVP violation?

Yes. Food from a foreign supplier may be detained without physical examination when it is imported through an importer covered by Import Alert 99-41 and the applicable FDA listing and enforcement criteria are met.

Does HACCP certification satisfy FSVP requirements?

Not by itself. HACCP or another recognized food-safety certification can provide useful supporting evidence, but the U.S. importer must still establish and follow an appropriate FSVP for each applicable food and foreign supplier.

What does DWPE mean?

DWPE means Detention Without Physical Examination. It allows FDA personnel to detain covered shipments at entry without first physically examining the food, based on the conditions described in the applicable import alert.

Does Import Alert 99-41 mean that the food has been proven unsafe?

Not necessarily. Import Alert 99-41 focuses on apparent non-compliance with FSVP requirements. The underlying issue may involve inadequate importer verification or records rather than a confirmed physical defect in the food.

Conclusion

FSVP is legally centered on the U.S. importer, but effective compliance depends on cooperation between the importer and the foreign supplier. Exporters that prepare product-specific hazard information, verification records, test results, traceability documents, and corrective-action evidence are better positioned to respond to buyer requests and reduce avoidable import disruption.

The most important question before shipment is not simply, “Do we have a food-safety certificate?” It is:

Can our U.S. FSVP importer verify this specific food, from this specific facility, using current and complete records?

Official Sources

• U.S. FDA Import Alert 99-41
• FDA Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
• FDA Final Rule on Foreign Supplier Verification Programs at a Glance

Reference date: June 30, 2026. This article is intended for general export-compliance information and does not constitute legal advice. Applicability should be reviewed according to the specific food, importer, foreign supplier, and transaction structure.