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FDA Publishes Q&A Guidance on Mandatory Food Recalls

  • The Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded, and that use or exposure to the food will cause serious adverse health consequences or death to humans or animals (a Class I recall).

  • On November 5, 2018, FDA released a final guidance, in the form of questions and answers, on how the Agency will use its mandatory recall authority. (Also see: 83 Fed. Reg. 55551, November 6, 2018.) FDA issued a draft guidance on this topic in 2015 and requested comments at that time (see our May 7, 2015 blog for more information on the draft). The final guidance provides additional clarity, including some modifications based on comments received.

  • In addition to explaining the mandatory recall process, the final guidance identifies evidence that FDA “might” consider when making the decision to proceed with a mandatory recall, namely: 1) observations made during inspections, 2) results from sample analyses, 3) epidemiological data, 4) vulnerability of the populations that normally consumes the food, 5) nature of the product, 6)Reportable Food Registry data, 7) consumer and trade complaints, and 8) whether the responsible party has failed to initiate a voluntary recall. (See Q&A #8 in the final guidance.)

  • FDA has only issued a mandatory recall order of a food product once. (See our April 4, 2018, blog on FDA’s recall order for kratom products.). In two other instances, FDA began the process to initiate a mandatory recall authority under FSMA but the companies ultimately chose to voluntarily recall their product.

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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...