FDA Finalizes Guidance on Public Warning and Notification of Recalls

The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018. The Guidance outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. The document’s recommendations apply to all voluntary recalls, including both firm-initiated and FDA-requested recalls, and covers foods and dietary supplements (as well as all other FDA-regulated products).

This blog provides background for FDA’s development of the Guidance, as well as a high-level summary of the Guidance’s recommendations.

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