The Food and Drug Administration (FDA) this week published guidance clarifying how and when it plans to use its authority to mandate a recall. In the guidance, FDA acknowledged that most companies coordinate with the agency and quickly initiate necessary food recalls. Since the Food Safety Modernization Act (FSMA) gave FDA this authority seven years ago, the agency has only mandated one food recall.
According to FDA Commissioner Scott Gottlieb, M.D., FDA issued the guidance to answer questions related to the mandatory recall that happened this past April. The guidance states that all foods and dietary supplements are subject to FDA’s mandatory recall authority under FSMA except for infant formulas. FDA has separate regulations for infant formula that already include mandatory recalls.
When mandating a recall, FDA said it will issue a press release, as well as alerts and public notices, to provide notification to affected consumers and retailers. The guidance states that these publications will include, at a minimum, the name of the food being recalled, a description of the risks associated with the product or products and information about similar foods that are not affected by the recall.
FDA encourages recall of a food if there is reasonable probability that it is adulterated or misbranded, or if it could cause serious adverse health consequences or death to humans or animals. In determining whether to mandate a recall under these circumstances, FDA said it will look at several data points, including:
- Whether the responsible party has failed to initiate a voluntary recall;
- Food safety observations that FDA makes during inspections;
- Results from sample analyses, which may include those for raw materials or finished food products, and certain sample swabs from the food facility manufacturing environment;
- Food-borne outbreak data that suggests disease or injuries have already occurred from product consumption or exposure; and
- If the food is ready to eat, raw or cooked.
For more information, contact John Allan, IDFA vice president of regulatory affairs and international standards, at jallan@idfa.org.