The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA).  Together with the release of this Guidance, FDA Commissioner Scott Gottlieb, M.D., released a statement addressing FDA’s goal of expanding use of the mandatory recall authority in cases where FDA has to intervene quickly to help protect consumers from unsafe foods.

The Guidance outlines how the FDA will give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall, as the law requires. It also offers more detail about the evidence or circumstances the FDA may consider when deciding to move forward with a mandatory food recall and provides clarity around situations when the FDA would deem a food a serious health risk. Commissioner Gottlieb’s statement explains that providing this additional clarity can enable the FDA to make more robust use of the mandatory recall authority.

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The U.S. Food and Drug Administration (FDA) has issued Draft Guidance on public warning and notification of recalls under 21 C.F.R. Part 7, and has announced steps to release recall information more quickly. The Draft Guidance provides recommendations to industry and FDA staff regarding the use, content, and circumstances for issuing public warnings and public notifications, and also discusses the parties responsible for issuing public warnings.  The document’s recommendations apply to all voluntary recalls, including both firm-initiated and FDA-requested recalls, and covers food, dietary supplements, and cosmetics (and other FDA-regulated products). Importantly, the Draft Guidance discusses the release of retail consignee information as a part of public warnings of recalls and signals that there may be more to come from FDA in this area. In addition, FDA issued a blog post, reflecting the Draft Guidance, announcing that the agency has adopted a new policy to release recall information in FDA’s weekly Enforcement Report, even when the recall has not yet been classified.

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