The U.S. Food and Drug Administration (FDA) has published a Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, building upon an immediate national strategy published in March 2023, which initiated first steps and research toward a long-term strategy. The long-term strategy is informed by studies of challenges facing the U.S. infant formula market conducted by the National Academies of Sciences, Engineering, and Medicine (NASEM).
Efforts by FDA to increase the resiliency and safety of the U.S. infant formula supply were prompted by the infant formula crisis of 2022, in which the nation faced a critical shortage of infant formula following a recall of product contaminated with Cronobacter sakazakii, resulting in the temporary shutdown of Abbott Nutrition’s Sturgis, Michigan facility, a major producer of formula in the U.S. Following the crisis, FDA commissioned NASEM to evaluate the U.S. infant formula market before and during the shortage, considering FDA’s response to the events. NSAEM’s report, which made recommendations to federal agencies about actions required to prevent future shortages, helped inform FDA’s newly released, long-term strategy.