Today, the U.S. Food and Drug Administration (FDA) announced new plans, via the issuing of final guidance, for how the agency will issue public warnings about voluntary recalls.
The new step FDA is taking will help ensure appropriate public warnings and notification of recalls when FDA-regulated products are involved. The guidance shed light on how companies can determine whether or not they should issue a public warning about a voluntary recall. The guidance also 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. Finally, the guidance goes into detail about FDA’s policy for moving forward with posting recalls to the FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA, in some cases before a final health hazard evaluation is completed.
Under the draft version of this guidance, FDA has previously announced consumer warnings for Kellogg’s Honey Smacks cereal, recalled vegetables from McCain Foods USA, Inc., romaine lettuce, and other non-food products. This guidance also led to FDA’s release of detailed retail distribution information during the Salmonella Adelaide outbreak linked to fresh pre-cut melons.
FDA Commissioner Scott Gottlieb says, “I remain committed to investing in the FDA’s recall and outbreak programs, building on our successes, and applying the FDA's leadership and expertise to protect American families and keep our nation safe.”
See Final Guidance: Public Warning and Notification of Recalls as it appears in the Federal Register.