FDA Releases Review of Response to Infant Formula Supply Crisis, Addresses Improvements
The U.S. Food and Drug Administration (FDA) has concluded its internal review of the agency’s response to the U.S. infant formula supply crisis, precipitated by a food safety incident involving Abbott Nutrition, a major formula supplier that issued a significant recall of Cronobacter sakazakii-contaminated product and halted production at its Sturgis, Michigan facility for several months. The report details key findings and recommendations that will allow the agency to respond more quickly during a public health emergency, which FDA Commissioner of Food and Drugs, Robert M. Califf, M.D., M.A.C.C., states the agency has already begun implementing.
The report is the result of information collected from over 40 interviews with more than 60 FDA staff members and leaders who were directly involved with the events that transpired during the infant formula crisis. The report focuses on aspects of the response that are within the agency’s purview and does not consider external factors, such as the limited number of existing infant formula manufacturers, weak links in the ingredient supply chain, and inadequate control of product distribution.