June 18, 2019

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Finalized Guidance for Industry and FDA Staff on Public Warning and Notification of Firm-Initiated or FDA-Requested Recalls

As covered on this blog, FDA has worked to strengthen the recall process for food, drugs, medical devices, and cosmetics in response to a report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s recall process can be too slow and puts consumers at risk.  21 CFR Part 7, Subpart C provides guidance on policy, procedures, and industry responsibilities for recalls (including product corrections).

Final guidance issued February 7, 2019 further outlines the circumstances when a company should issue a public warning about a voluntary recall (i.e., where there is a serious health risk and other means for preventing the use of a recalled product appear inadequate), describes the general timeframe for companies to issue such a warning (i.e., generally within 24 hours of notification that FDA believes a public warning is appropriate), discusses what information should be included in a public warning (including how to identify the recalled product and characterize the reason for the recall), and describes situations where FDA may issue its own public warning if a company’s warning is deemed insufficient.  The final guidance also describes FDA’s policy for moving forward with posting recalls to FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA (including recalls that do not present serious hazards to health).  A recall may sometimes be posted to FDA’s Enforcement Report website before a final health hazard evaluation is completed.

FDA Commissioner Dr. Scott Gottlieb announced the final guidance on public warning and notification of recalls in a press release and also touted FDA’s other recent measures to protect consumers from health risks related to recalled products.  Such measures include draft guidance that describes situations where FDA will disclose retail information for recalled food products and mandatory recall guidance for foods, which was finalized in November 2018 and answers common questions about the mandatory food recall provisions.

Dr. Gottlieb further remarked on FDA’s implementation of the public warning and notification guidance last year while it was still in draft form, suggesting that FDA’s more prominent publicizing of recalls through social media and other routes may have given the impression that the number of recalls has increased when, in fact, the number of recalls in fiscal year 2018 (i.e., 7,420 recalls; 831 of which were classified as the highest risk) represents a five-year low.

© 2019 Keller and Heckman LLP


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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...