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 cases where FDA has to intervene quickly to help protect consumers from unsafe foods.
The Guidance outlines how the FDA will give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall, as the law requires. It also offers more detail about the evidence or circumstances the FDA may consider when deciding to move forward with a mandatory food recall and provides clarity around situations when the FDA would deem a food a serious health risk. Commissioner Gottlieb’s statement explains that providing this additional clarity can enable the FDA to make more robust use of the mandatory recall authority.