On March 8, the FDA sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our infants.

The agency notes that since the 2022 infant formula recalls and resulting shortages, it has been working to improve the resiliency of the infant formula supply by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate products in the U.S. marketplace through the exercise of enforcement discretion. The FDA has also taken steps to enhance the safety of powdered infant formula through the development of a Cronobacter prevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate.

In addition, over the past two months, food safety staff have been meeting regularly with manufacturers to further develop the prevention strategy to help prevent Cronobacter illness associated with consumption of powdered infant formula. The letter sent to manufacturers reflects the information the agency gained through interactions with industry as well as the latest available science on improving the microbiological safety of powdered infant formula.

The FDA called on members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for the protection of infants. In addition to this call to action, Congress recently added new requirements for manufacturers aimed at mitigating supply chain disruptions through mandatory shortage notifications and risk management plans.