Education has moved to enforcement at the U.S. Food and Drug Administration, and your business needs to act now to protect its supply chain.

An early 2019 Salmonella outbreak has motivated the FDA to exercise its enforcement authority to halt imports for food products at the docks if the importers do not have an appropriate Food Safety Verification Program (FSVP).

The outbreak was linked to tahini imported from Palestine, and it was later revealed that the importer, Brodt Zenatti Holdings LLC, failed to maintain a FSVP to assess risks and ensure that food imported to the U.S. has been produced in compliance with applicable U.S. food safety standards.

The FDA’s authority to require importers to develop FSVPs is rooted in the Food Drug and Cosmetic Act. It includes the parameters for the FSVP, which now requires compliance by most importers.

Although the FDA began inspection for FSVP compliance in 2017, its August 2019 FSVP Warning Letter to Brodt Zenatti Holdings LLC was the first of its kind. It reveals that the FDA has prioritized addressing food safety risks of imported products, and has moved from an “educate while we regulate” ideology to enforcement.

Detaining a company’s imports for their risks to consumers is perhaps the most critical mechanism the FDA has at its disposal. Those imports can be detained indefinitely, and in many cases, without inspection of the lot waiting at the border. Foreign suppliers linked to food safety concerns may also have trouble importing other products. The FDA published Import Alert 99-41 at the end of July to remind importers that articles of human and animal food may be detained without physical inspection if the importer is on the “Red List.” Noncompliance with FSVP is one way to be added to the Red List.

If your business imports human or animal food products or components, it is imperative that you review your FSVP immediately to ensure it is adequate under the regulations. If your business relies on imports purchased from another importer, it is critical that you verify with your importer that all FSVP parameters are met, so that you do not lose access to your supply.

If you have any questions about FSVP, how it affects your business, or need assistance with FSVP, please contact me or anyone in the Barley Snyder Food & Agribusiness Industry Group.