By Dave Fairfield, Senior Vice President of Feed Services
The U.S. Food and Drug Administration (FDA) on Nov. 5 released a final guidance that provides information about the agency’s mandatory recall authority established under the Food Safety Modernization Act (FSMA).
FSMA provided FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under FDA regulations, and that the food could cause serious illnesses or death. Under the authority, FDA is to give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to FSMA, FDA relied on manufacturers to voluntarily recall food products.
FDA’s final guidance provides questions and answers on the agency’s mandatory recall process, explains what FDA considers when moving forward with a mandatory recall, and addresses other issues.
To date, FDA has used its mandatory recall authority only once. In April 2018, FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several products were found to contain salmonella. As such, the agency continues to work with firms to facilitate orderly and prompt voluntary removal of potentially unsafe products from the food supply. FDA recall coordinators are available to work with firms when recalls are necessary. In addition, state feed regulatory officials typically assist during feed recall situations.