Last week, FDA announced the availability of a draft guidance to instruct industry on the implementation of FDA's mandatory food recall authority. The Food Safety Modernization Act ("FSMA") enacted in January 2011 gave FDA recall authority with respect to FDA-regulated foods, other than infant formulas. Prior to enactment of FSMA, FDA relied on manufacturers to voluntarily recall food products. Now, FDA has the authority to recall food if it believes the food is adulterated or misbranded and the use of or exposure to such food will cause serious adverse health consequences or death to humans or animals. The new draft guidance, in Q&A format, answers questions such as, what foods are subject to FDA's mandatory food recall authority, what are the criteria for a mandatory recall, and what is the process FDA must follow for a mandatory recall. FSMA also requires the Department of Health and Human Services ("HHS") to submit annual reports to Congress on the use of the recall authority. This past February, FDA reported that since 2011, it has exercised its food recall authority only twice—in a 2013 recall of Salmonella-tainted pet treats and in a 2014 recall of dietary supplements.
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