The U.S. Food and Drug Administration (FDA) has issued Draft Guidance on public warning and notification of recalls under 21 C.F.R. Part 7, and has announced steps to release recall information more quickly. The Draft Guidance provides recommendations to industry and FDA staff regarding the use, content, and circumstances for issuing public warnings and public notifications, and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 Importantly, the Draft Guidance discusses the release of retail consignee information as a part of public warnings of recalls and signals that there may be more to come from FDA in this area. In addition, FDA issued a blog post, reflecting the Draft Guidance, announcing that the agency has adopted a new policy to release recall information in FDA’s weekly Enforcement Report, even when the recall has not yet been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