FDA Issues Guidance on New Mandatory Recall Authority for Food
The Food and Drug Administration on Nov. 5 issued a new guidance document outlining its mandatory recall authority under the Food Safety Modernization Act. The guidance includes a series of questions and answers on the basis for the relatively new authority, the process followed, what foods may be subject to mandatory recalls and how FDA determines whether a recall is necessary. Under FSMA, the “responsible party” for carrying out a mandatory recall is the food facility required to register with FDA that manufactured, processed, packed or held the food. FDA will give facilities a chance to conduct a voluntary recall before it exercises its mandatory recall authority, the agency said.
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FDA has only once issued a mandatory recall order, in April 2018, for food products containing kratom from Triangle Pharmanaturals LLC that were found to contain salmonella, the agency said in a constituent update. "In two other instances, FDA started down the path of using its mandatory recall authority under FSMA until the companies ultimately chose to voluntarily recall their product," it said.