FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA

The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act (FSMA) regulations. Under the FSVP rule, importers must take steps to verify that their foreign suppliers produce food that satisfies U.S. food safety standards. FDA issued the Warning Letter to the importer of tahini implicated in a recent Salmonella outbreak. According to the FDA, the importer did not have an FSVP in place for the imported tahini. This memorandum summarizes the Warning Letter and provides analysis of the key takeaways for FSVP enforcement.