New steps announced to strengthen FDA process for issuing public warnings on voluntary of recalls

The FDA announced draft guidance for strengthening public warnings and notifications of recalls. They are taking a new step to help ensure appropriate public warnings and notification of recalls when FDA-regulated products are involved. The guidelines describe circumstances when a company should issue a public warning about a voluntary recall, describing 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 FDA claims that in 2018 there were 7,420 recalls with 831 that were classified as the highest risk. That number represents a 5 year low. The figure seems higher because the FDA is communicating more frequently and, in many cases, directly to consumers through the agency’s social media. Scott Gottlieb, M.D., the FDA Commissioner, claims that “Our ability to detect, track and trace potential or known problems with products continues to improve as we implement new technologies across the agency and as companies implement their own technological advances throughout their supply chains. “The FDA is working to improve product traceability by tapping into modern approaches, such as blockchain technology, to further advance our mission of protecting public health. @ https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630906.htm?utm_campaign=020719_Statement_new%20steps%20to%20strengthen%20process%20for%20issuing%20public%20warnings%20of%20recalls&utm_medium=email&utm_source=Eloqua