FDA Enters New Phase of FSVP Enforcement

The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due diligence program to review and approve foreign suppliers of imported food. In May 2020, FDA placed two companies on Import Alert 99-41, which is essentially an import ban where an importer cannot import the food until they implement an appropriate FSVP to FDA’s satisfaction.

This is not the first time FDA placed a company on Import Alert 99-41. However, the previous import alert listing concerned a company that imported food associated with a recall and foodborne illnesses. In this instance, there is no indication that the food caused any food illnesses or was otherwise non-compliant; rather, it appears that the only issue was the importers failed to comply with the FSVP requirement.

This inherently changes the tenor of an FSVP inspection because they now carry the threat of meaningful consequences (import refusals) for failing to comply, regardless of whether any evidence establishes that the food is unsafe or otherwise non-compliant. In addition to importers, this action affects those whose supply chains depend on imported food.

In June 2020, FDA refused the first food shipment because the U.S. importer did not comply with FSVP. This signals that the “education” phase of FSVP implementation is over and now FDA will issue an import refusal for failing to comply with FSVP, even if there is no evidence that the food is non-compliant.

To learn more, contact Shook Of Counsel John F. Johnson for a white paper about this shift and what companies can do to avoid to the import alert.