First Warning Letter for Failure to Develop Foreign Supplier Verification ProgramAugust 20, 2019
On August 13, 2019, FDA announced that it has issued the first Warning Letter (WL) for a violation of the requirements for a Foreign Supplier Verification Program (FSVP). This is a good reminder for importers that they must have a FSVP for each food for which they are the FSVP importer.
The Food Safety Modernization Act (FSMA) provided FDA with a new tool to enhance FDA’s oversight of foreign food facilities and farms. Under the FSVP requirements, a U.S.-based FSVP importer must conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable U.S. food safety provisions. The first FSVP compliance date was May 30, 2017. By now, most importers of human foods are past the compliance date and all FSVP importers of food, unless exempted, must have developed a FSVP.
The FSVP regulations for the first time assigned importers of food (including dietary supplements) the responsibility to ensure that the products they bring into the United States are held to the same safety standards as domestically produced food. FDA recognized that this was a new concept to a lot of importers which previously may not have had any dealings with FDA. FDA indicated that it would apply the same approach as it had done previously with the introduction of other new FSMA regulations, i.e., educate while regulating to create a culture of compliance but take swift action when it becomes aware of food safety problems that pose an imminent public health risk.
The first WL concerning the FSVP was issued to Brodt Zenatti Holdings LLC in Jupiter, Florida. The Company imported tahini which, in May 2019, had been implicated in a Salmonella outbreak. After identifying the importer, FDA conducted an FSVP inspection. According to the WL, FDA found that the importer did not develop an FSVP for the imported tahini as required. As with everything imported, the consequences of a violation of the applicable regulations may have serious consequences. As mentioned in the WL, if it fails to take the appropriate corrective actions, FDA may place the Company on the newly created import alert 99-41 resulting in all foods that the Company imports being detained without physical examination. (The tahini contaminated with Salmonella already is subject to DWPE under import alert 99-19).