FDA has 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 unsanitary conditions at one of the nation’s largest infant formula facilities, which led to a significant voluntary recall and multiple-month production shutdown.
As directed by Congress in the Food and Drug Omnibus Reform Act of 2022, the national strategy details the agency’s plans to improve the formula supply. It also traces the events that led up to and followed the voluntary recall of formula by Abbott Nutrition in February 2022, the temporary pause in production at the company’s facility in Sturgis, Michigan, as well as other factors that contributed to and exacerbated the shortages.
This strategy represents a first step toward issuing, with input from the National Academy of Science, Engineering and Medicine, a long-term national strategy in 2024 to improve preparedness against formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the 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.