The FDA took action against a U.S. importer who failed to establish procedures to verify food safety standards of their foreign suppliers. While investigating a salmonella outbreak that was traced back to a particular brand of tahini, FDA investigators visited the offices of the U.S.-based importer Brodt Zenatti Holdings LLC. To their surprise they discovered the importer had neglected to meet the FDA’s food safety requirements. As a result FDA issued the importer a Warning Letter and an Import Alert ordering detention of all associated tahini products.
The Foreign Supplier Verification Program (FSVP) rule was issued by FDA after passage of the Food Safety Modernization Act signed into law in 2011. The FSVP rule requires importers to perform “risk-based activities” to verify that the food they bring into the United States has been produced in a manner that meets U.S. food safety standards. Most importers were required to put in place FSVP programs by 2019, while some qualified small business have until 2020 to comply.
So if you are a U.S. food importer, I’m sure you are wondering how the FSVP rule applies to you. For starters you need to pay attention because compliance with FSVP is mandatory. Importers found in violation of the FSVP rule can face a variety of penalties, from seizure of the imported products to criminal prosecution. The FDA is currently conducting regulatory audits of importers and has made this new initiative their priority. Fortunately, there is still time to put a FSVP plan in place.
If you have questions about FSVP or need to develop a FSVP plan, please feel free to schedule a call with our attorneys at SINI Healthcare LLP.