Tag: form 483

FDA Issues First Warning Letter for Failure to Comply with FSVP

FDA issued their first Warning Letter to an importer for not complying with the Foreign Supplier Verification Program (FSVP) that was introduced 8 years ago with the Food Safety Modernization Act (FSMA).

For this first Warning Letter, FDA selected a food importer that was associated with an outbreak of foodborne illness. In May of this year (2019), a Salmonella outbreak was identified as originating from tahini products imported by Brodt Zenatti Holding. Following current practices, FDA, Center for Disease Control (CDC), and state health officials worked together to identify the outbreak’s source and remove the product from the market. This led to Brodt Zenatti (the importer) issuing a recall and voluntarily ceasing to import the product.

Beyond the recall, FDA conducted an FSVP inspection of the importer only to identify that they needed to “develop an FSVP for sesame paste tahini manufactured by Karawan Tahini and Halva in the West Bank.” When FDA completed the inspection, they issued a Form 483 observing this violation of the Food, Drug, and Cosmetic Act. The importer never responded and thus FDA issued a public Warning Letter.

Noticeably, the importer failed to respond to FDA’s Warning Letter and voluntarily resolve the issue. FDA has threatened to place the importer on a new import alert, which lists companies that fail to comply with FSVP. Once an importer is placed on this list, FDA will not allow it to import the covered food product until the importer has resolved the violation (which we discussed more here).

With this first Warning Letter, FDA is seeking to connect failing to comply with FSVP and the risk of violative products entering the food supply, which could cause illnesses and injury. Attorney John Johnson explains, “this Warning Letter is also a cautionary tale for importers, if their products are associated with a recall, especially one involving illnesses or injuries, FDA will conduct an inspection of the FSVP program to ensure its existence and implementation.”

This represents the beginning shift away from “educate while you regulate” to traditional regulation and enforcement. 

If you need help understanding your FSVP obligations or with any of your importing needs, please contact us and get professional advice from our consultants and affiliated attorneys.