FDA publishes draft guidance on mandatory food recalls.
- Among other things, the FDA Food Safety Modernization Act (FSMA) granted the Agency the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded and that use of or exposure to the food will cause serious adverse health consequences or death to humans or animals (i.e., a “Class I recall”).
- On May 6, 2015, FDA published draft guidance for industry, in the form of questions and answers, on how FDA will use its mandatory food recall authority. The draft guidance includes a description of the process FDA will follow when the Agency decides to move forward with a mandatory food recall; on making this determination, the Agency “must first provide . . . an opportunity to voluntarily cease distribution and recall the article of food.” User fees and civil penalties may be imposed not only for failure to initiate a recall as ordered by FDA, but also for failure to conduct the recall “in the manner specified by FDA” or for not providing FDA with requested information related to the recall. The guidance identifies evidence the agency “might” consider when making the decision to proceed with a mandatory recall, including:
- Observations made during inspections of the responsible party or other parties;
- Results from sample analyses;
- Epidemiological data;
- Reportable Food Registry data; and
- Consumer and trade complaints.
- The draft guidance highlights that FDA’s mandatory food recall authority gives the Agency greater leverage than ever over the industry in a potential recall situation. FDA has invoked its mandatory recall authority twice so far; although in both cases the companies ultimately voluntarily recalled affected product, FDA’s actions show the Agency is not afraid to flex its mandatory recall muscle.