The Food and Drug Administration has unveiled a long-term strategy intended to prevent future infant formula shortages, as occurred in 2022 after Abbott Laboratories recalled powder formulas and shut its Michigan plant down temporarily.
In the 26-page document, FDA committed to conducting surveillance food safety inspections of all infant formula manufacturers "at least annually." It also said it would set annual targets for collecting infant formula samples, improve infant formula training for investigators and continue enhancing its methods for handling consumer and whistleblower complaints.
The agency also said it would work to improve its knowledge of infant formula contamination, looking at new scientific data as requested by the federal 2023-25 National Advisory Committee on Microbiological Criteria in Foods.
To strengthen the infant formula supply chain's resiliency, FDA intends to continue tracking production information provided by manufacturers, use state-level data to watch for shortages and conduct timely pre-market reviews of new infant formula submissions.
The strategy also says the agency plans to work with non-federal partners to plan for and track shortages, communicate more effectively with the public and medical professionals, and analyze current regulations to see if updates are needed.
The strategy replaces an earlier plan the agency put in place in 2023 in response to the nationwide infant formula shortage that began after Abbott's recalls of popular formulas such as Similac, Alimentum and EleCare. Since that strategy took effect, "the U.S. market has "experienced relatively minor supply chain disruptions resulting from product recalls, natural disasters, or regulatory actions due to failures to meet the FDA requirements for infant formula."
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