Infant formula shortage prevention: FDA releases strategy

Following a months-long infant formula shortage in the US in 2022, the U.S. Food and Drug Administration (FDA) has now released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The formula shortage happened when one of the country’s largest infant formula facilities was shut down multiple times after a significant voluntary recall of its product.

The strategy describes immediate actions the FDA took to address the shortage and it details the agency’s plans for improving the resiliency of the infant formula supply, while noting issues beyond the scope of the FDA. It also traces the events that led up to and followed the recall of infant formula by Abbott Nutrition in February 2022, the temporary pause in production at the facility in Michigan and the pantry loading that peaked in May 2022, which may have been driven in part by an overemphasis on shortages being reported in the media, as well as numerous other factors that contributed to and exacerbated the shortages.

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

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