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Gottlieb Announces Plans to Strengthen Recall Process and FDA Publishes Draft Guidance to Clarify Its Approach to Product Recalls

  • As previously covered on this blog, a recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s current recall process can be too slow and puts consumers at risk.  Yesterday, FDA Commissioner Dr. Scott Gottlieb announced plans to strengthen the recall process for food, drugs, medical devices and cosmetics.

  • Today, FDA published a draft guidance (83 FR 2758) aimed at clarifying its approach to notices and warnings about recalled products to ensure consumers learn about such issues in a more timely way.  The Federal Register Notice announcing the draft guidance states that the intent of the draft guidance is to “increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled.” FDA also states that the draft guidance “clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.”

  • The draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning,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 The draft guidance also sets out the Agency’s policy for posting recalls to FDA’s Enforcement Report before a final health risk determination is made.

  • In a press release, Dr. Gottlieb stated that new policies regarding the type of information the FDA shares with the public to identify “hazardous recalled food,” as well as a new approach to publicizing food recalls are being developed.

  • FDA will be accepting comments on the draft guidance until March 20, 2018.

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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...