FDA Issues Warning Letters to Importers for FSVP Violations

U.S. Food and Drug Administration (FDA) recently issued multiple Warning Letters to importers for failing to comply with the Foreign Supplier Verification Program (FSVP). This program requires all importers of food and dietary supplements to verify their foreign suppliers compliance with U.S. food safety regulations. If the FDA identifies a shipment in violation of FSVP, then the FDA may issue a Warning Letter to the importer that gives them 15 days to correct the violation. If the violation is not remedied, then the FDA may seize the products, require them to be destroyed or reexported.

Pursuant to FSVP rules, before you ship food or supplements to the U.S. you must have a FSVP plan in place. You are also required to have an FSVP Agent physically located in the U.S. to carry out your FSVP Plan.

In one instance, the FDA cited a New Jersey based importer of food products from India for failure to establish a FSVP Plan and to verify its foreign suppliers. In another letter, the FDA cited a Texas based food importer for not developing, maintaining and following an FSVP, in addition to not knowing the actual identity of the product manufacturer. A California based importer was issued a Warning Letter for multiple violations, including not developing, maintaining and following an FSVP, not reviewing suppliers based on an FSVP Plan, and multiple label violations.  Lastly, a Washington based food importer was cited for not developing an FSVP Plan for any of the foods it imports.

The key takeaways here is that the FDA is continuing to focus their enforcement efforts on FSVP compliance. All of the companies cited for violations have been small businesses, which means the FDA's focus may be on your company next. Setbacks like these could cost your business valuable time and money.

If you are already importing to the U.S., but have not implemented an FSVP program, it's not too late. US Imports can help develop you develop a FSVP Plan to ensure compliance with FDA regulations. We can also serve as your qualified U.S.-based FSVP Agent to carry out your plan and verify your foreign suppliers. Have questions? Please contact us to learn more.