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FSVP Follow-up

  • With little fanfare, Food Drug Administration (FDA) issued a new Import Alert (IA 99-41) to prevent the importation of foods by importers who are not in compliance with the Foreign Supplier Verification Program (FSVP) Regulation.  The FSVP regulations require importers to evaluate and document their suppliers and the steps taken to ensure the safety of food being imported.  Each food item being imported must have its own FSVP review.

  • An Import Alert is guidance within the FDA that certain shipments into the United States should be held until the importer proactively demonstrates compliance with the law.  Additionally, Import Alerts generally explain the problem and provide guidance to FDA field staff on how to uniformly describe the problem in paperwork.  The Import Alert will often have a green list (as an exception to a general rule to prevent products from coming in), a yellow list (to identify entities that are known to be working towards compliance but whose products are still to be detained), or a red list (the specific entities whose products will be detained) of entities.  For example, IA 45-02, for detention of foods containing illegal and undeclared colors has both a green and red list and IA 22-01 for detention of cantaloupes from Mexico has both a green and yellow list.

    • The import alert for FSVP violations directs field staff to consult the red list but, thus far, the red list is empty.  This implies that FDA expects to use the import alert process as a means of targeting importers who do not comply with their regulatory obligations for FSVP.

  • Of interest, the beginning of produce safety inspections, addressed in yesterday’s Daily Intake Blog post, is important not just for produce operations – FDA has previously indicated that it will begin FSVP inspections of importers of produce from large farms “in Fall 2019” which would allow for these inspections to begin “approximately six months after FDA begins routine inspections of those large farms under the Produce Safety rule.”  It may be that the FSVP inspections of imports of produce from large farms will result in the first additions to the red list for IA 99-41.  Given FDA’s policy of using initial FSVP inspections to educate, we might expect the first entrants on the red list to be importers who have already undergone FSVP inspections.

© 2021 Keller and Heckman LLPNational Law Review, Volume IX, Number 221
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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