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

Constituent Update

March 28, 2023

The U.S. Food and Drug Administration 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 insanitary 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 describes immediate actions the FDA took to address the infant formula shortage and details the agency’s plans for improving the resiliency of the infant formula supply, while noting multiple issues beyond the purview of the FDA. It also traces the events that led up to and followed the voluntary recall of infant formula by Abbott Nutrition in February 2022, the temporary pause in production at the facility in Sturgis, Michigan, and pantry loading that peaked in May 2022, likely driven in part by an overemphasis on other shortages being reported in the media, as well as numerous 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 (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.

The FDA remains committed to improving the resiliency of the U.S. infant formula supply and ensuring that consumers have confidence that the formula they feed their children is safe and nutritious.

For more information

• Status Update on FDA’s Infant Formula Response Activities
• Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula
• Letter to the Infant Formula Industry
• Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
• Press Release: FDA Outlines Immediate National Strategy to Further Increase the Resiliency of the U.S. Infant Formula Market