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The US Food and Drug Administration (FDA) has released a national strategy that outlines actions it will take to ensure the continued supply of safe, nutritious infant formula and to increase resiliency of the US infant formula market. FDA commissioner, Robert Califf, said: “Safety and supply go hand-in-hand. We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage. That’s why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible.” The Food and Drug Omnibus Reform Act of 2022 (FDORA) directed the FDA to develop the strategy, which includes creating and implementing redundancy risk management plans to help the industry identify risks to infant formula supply chains and to develop mitigation plans against potential disruptions that could impact production. FDORA also called on the FDA to trace the events that led up to and followed the voluntary recall of infant formula in February last year by Abbott Nutrition, the temporary pause in production at its facility in Sturgis, Michigan, and the factors that contributed to the fragility of the supply chain. The strategy also states continued and enhanced inspections of infant formula manufacturers, including expanding and improving infant formula training for investigators, and the development of a forecasting model to enable FDA to prepare for and mitigate future supply disruptions. It stresses the continued monitoring of the infant formula supply and engagement with US government partners who help mitigate other factors that could impact supply, such as tariffs and market concentration. It also mentions working with the US Department of Agriculture to support efforts to build resiliency, improving the agency’s consumer education materials relating to infant formula on its website, and enhancing and leveraging the FDA’s partnerships with healthcare providers and professionals to further expand the agency’s consumer education programme. All of the aforementioned actions are described in the report as “well underway”. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, commented: “The immediate strategy released today will play an important role in increasing the resiliency of the infant formula market as the agency continues its critical work to improve industry processes and programmes for the protection of those who rely on infant formula while incentivising additional infant formula manufacturers to enter the market.” With input from the National Academies of Science, Engineering and Medicine, this initial strategy represents a first step toward issuing a long-term national strategy to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, measures for protecting the integrity of the infant formula supply chain and preventing contamination. The long-term strategy is designed to increase supply, mitigate future shortages and recommend necessary authorities to gain insight into the supply chain and it’s shortage risks. The long-term strategy is due to Congress one year after enactment – the FDA anticipates the strategy to be issued in early 2024. You may also like to read: