FDA Publishes Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market

On March 28, FDA released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy follows a months-long infant formula shortage sparked by the temporary shutdown of Abbot’s facility in Sturgis, Michigan in February 2022 due to positive test results in the facility for Cronobacter sakazakki and an outbreak of food-borne illness among infants who had been exposed to infant formula produced at the facility. To view our past blog posts regarding FDA’s response to last year’s infant formula crisis, please follow this link.

As directed by Congress in the Food and Drug Omnibus Reform Act of 2022, FDA devised a national strategy describing the immediate actions the Agency took to address the infant formula shortage and detailing the Agency’s plans for improving the resiliency of the infant formula supply. Among other things, FDA is working to conduct surveillance food safety inspections of all infant formula manufacturers at least annually, use remote regulatory assessments, expand and improve infant formula training for investigators, monitor the infant formula supply and supply chain, expedite review of premarket submissions for new infant formula products to mitigate or prevent shortages, and build a consumer education program.

This strategy represents a first step toward issuing, with input from the National Academy of Science, Engineering and Medicine (NASEM), a long-term national strategy in 2024 to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain, and preventing contamination.  The long-term strategy will also explore new approaches to help facilitate entry of new infant formula manufacturers to increase supply and mitigate future shortages and recommend other necessary authorities to gain insight into the supply chain and risks for shortages.