Foreign Supplier Verification Programs for Food Importers

The FSVP importer is defined by ownership or consignment at the time of entry, with a representative arrangement when no U.S. owner or consignee exists. That role is not automatically identical to the customs broker or importer of record. Establishing who carries the duty is the first step before allocating supplier checks or obtaining entry information. FDA rule explanation.

The importer develops and follows an FSVP for each covered food and foreign supplier. Hazard analysis and evaluation consider the food’s risks and supplier performance. The supplier’s procedures, regulatory compliance and relevant food-safety history inform approval. A broad statement that a supplier is reputable is not the required risk-based evaluation. Subpart L.

Verification can include onsite audits, sampling and testing, and review of relevant supplier records. The regulation gives particular treatment to serious hazards controlled by the foreign supplier, including conditions for using an alternative to an annual onsite audit. The choice and its rationale must fit the food and supplier, rather than rely on an unrelated certification logo. FDA final-rule overview.

Required records document the program, evaluations, verification and corrective actions. Reliance on work performed by another entity requires the importer’s review and assessment under the applicable provisions. Problems such as an inadequately controlled hazard require an appropriate response and reassessment. Outsourcing an audit does not automatically outsource the importer’s legal responsibility. FDA FSVP guidance.

Seafood and juice meeting their respective HACCP provisions have specific exemptions. The low-acid canned food treatment is limited with respect to microbiological hazards controlled by Part 113. Dietary supplements and certain small-importer situations have modified requirements. These are not a single blanket exception for all foods in a shipment or all activities of a business. Subpart L.

Map each food to its manufacturer and identify the importer responsible at entry. Document coverage, hazard evaluation, supplier approval and the verification selected. Keep the records needed to show how another entity’s work was assessed and how problems are corrected. FDA’s January 2023 final guidance explains the rule without replacing its binding text. FSVP guidance.