FSVPs Needed Even for Countries with Equivalent Food Safety Systems

The FDA continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program, which requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards.

In a recent warning letter the FDA noted that one company official expressed a belief that the company did not need to comply with the FSVP regulation because the products were imported from a country the FDA has recognized as having an equivalent food safety system to that of the U.S. However, the FDA said such imports still require an FSVP, although the company could choose to follow the modified requirements in 21 CFR 1.513, including documenting that the foreign supplier is in good compliance standing with the foreign food safety authority.

The FDA therefore determined that the importer failed to develop, maintain, and follow FSVPs with respect to imports of three unnamed products. The importer has 15 working days to provide information on the specific things it is doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of violative products and subjecting the importer to detention without physical examination.