The Food and Drug Administration is considering setting up a dedicated cadre of investigators for infant formula production as part of a strategy to prevent contamination of the product.
The agency said Tuesday it is also considering realigning staff across the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs to better support regulatory oversight of infant formula.
Between September 2021 and February 2022, FDA received complaints about four cases of illness or death in infants who consumed powdered infant formula.
FDA has been unable to determine whether the infants became sick from contaminated product linked to Abbott Nutrition's Sturgis, Michigan, infant formula facility and Cronobacter sakazakii bacteria, but the illnesses brought widespread attention to the need to make improvements in overall infant formula safety.
Over the next several months FDA said it intends to work with stakeholders to finalize a strategy to prevent future illnesses.
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FDA also plans to review and update its infant formula compliance program to reflect current science on cronobacter, and ensure investigators and compliance officers are equipped with the tools and resources needed to enable a consistent and comprehensive approach to inspections of infant formula manufacturing facilities.
FDA is also looking to evaluate current testing requirements and determine whether improvements might be appropriate to enhance the safety of finished product.
The strategy also looks to continue developing and improving communications for consumers about safe formula preparation and storage.
The strategy also proposes to conduct and support research on cronobacter and work with other federal, state and local agencies to empower public health officials to identify and investigate cronobacter illnesses.
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