FDA Asks Infant Formula Industry to Double-Check Food Safety Controls
In a letter addressed to infant formula manufacturers, packers, distributors, exporters and importers, and retailers, top U.S. Food and Drug Administration (FDA) officials called upon industry to help the agency in protecting infants by ensuring the safety of their food. The letter was signed by FDA Commissioner Robert M. Califf, M.D. and Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Susan T. Mayne, Ph.D.
Throughout 2022, FDA was faced with a national infant formula crisis precipitated by a food safety incident involving major supplier Abbott Nutrition, which involved a significant recall of Cronobacter sakazakii-contaminated product and halted production at Abbott’s Sturgis, Michigan facility for several months. After dealing with the unsafe formula and subsequent supply shortages, FDA reviewed its response to the crisis and developed a prevention strategy for Cronobacter contamination of powdered infant formula.