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Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018.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

The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA).  Together with the release of this Guidance, FDA Commissioner Scott Gottlieb, M.D., released a statement addressing FDA’s goal of expanding use of the mandatory recall authority in

On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety. Additionally, on September 27, 2018, FDA published a Federal Register Notice announcing availability of a draft guidance on the Public Availability of