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FSVP – Five Years After Roll Out, Importers Receive A Failing Grade
It has been nearly five years since FDA began inspections under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) regulations. Based on inspectional data from FDA’s Data/Compliance Dashboard for the last three years (2019-2022 YTD) FDA has conducted 1,645 FSVP inspections, of which only 17 inspections were found to comply with FSVP regulations – equaling a compliance rate of 1%… Giving the importing community a failing grade for their compliance with FSVP!
As a result of the enactment of FSMA in 2011, Congress mandated that FDA create regulations for a food safety system focusing on prevention rather than reacting to problems after they occur. Among other things, FSMA outlines rules for Hazard Analysis Critical Control Points (HACCP), which are risk-based preventive controls for food facilities that manufacture/process, pack, and hold human and animal foods. These rules apply to domestic food producers and those in other countries who export to the United States.
Over the last several years, the FSVP regulation has negatively impacted most food importers. FSVP requires importers to be responsible for approving their own suppliers by verifying that they meet certain food safety standards. Other than a few exceptions, the FSVP importer (i.e., the owner of the food at the time of importation) is required to develop, maintain, and follow a compliant FSVP for each food imported. FSVP compliance aims to ensure that food is produced in a manner that provides a specific level of public health protection, including preventive controls, safety regulations, and that helps to ensure that the food is not adulterated or misbranded concerning allergen labeling.
Leading up to FSVP’s implementation in May 2017, FDA was diligent in educating the industry on FSMA and the rules of importing affecting the importer community. The phrase “Educating while Regulating” was FDA’s strategy during the first couple of years of FSVP roll-out, with the Agency using enforcement discretion alongside its industry education efforts. Now, however, FDA has ramped up its enforcement of these regulations, placing many importers on Import Alert. And such administrative actions can be catastrophic to businesses; once on an import alert, FDA will continue to detain the affected products until the manufacturer, shipper, grower, or importer proves to the satisfaction of FDA that the violation has been corrected.
Importer’s FSVPs need to be in place and available for review upon request from FDA. During the last few years, we have seen changes in the Agency’s enforcement strategy with the issuance of Warning Letters. In October 2019, the first firm was placed on Import Alert 99-41, “Detention without Physical Examination of Human and Animal Food Imported from an FSVP Importer Who is Not in Compliance with the Requirements of the Foreign Supplier Verification Program Regulation.” Since that time many more have been issues and now there are currently 27 importers on this particular import alert alone.
Brian Ravitch, a Senior Regulatory Advisor with FDAImports, was instrumental in developing and implementing FSVP for the FDA. Mr. Ravitch has achieved a Level ll certification in Seafood HACCP and is a Qualified Individual in Preventive Controls. Currently, he primarily concentrates on Import Compliance, Foreign Supplier Verification Program (FSVP), Seafood HACCP, and Hazard Analysis Risk-based Preventive Controls.
Brian and the staff at FDAImports have the knowledge and experience to help you meet FSVP requirements with the ultimate goal of compliance; if you have legal questions relating to FSVP, please contact us or call at 410.220.2800.
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