March 8, 2023
Today, the U.S. Food and Drug Administration sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our most vulnerable population.
Last year, safety concerns at one of the largest infant formula manufacturing facilities in the country led to a nationwide recall and temporary pause in production, which has had ripple effects across the infant formula supply chain. Since that time, the FDA has taken many steps to improve the resiliency of the infant formula supply, including by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula products in the U.S. marketplace through the exercise of enforcement discretion. The agency has also taken steps to enhance the safety of powdered infant formula through the development of a cronobacter prevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate.
The FDA has also reviewed food safety and operating conditions during ongoing inspections of powdered infant formula manufacturers. In addition, over the past two months, food safety staff have been meeting regularly with the powdered infant formula manufacturers to further develop the prevention strategy to help prevent Cronobacter illness associated with consumption of powdered infant formula. These meetings have allowed for a meaningful dialogue with manufacturers about their current food safety practices, including practices the FDA has observed during inspections, and opportunities for improvements. The letter sent today reflects the information we gained through these interactions and the latest available science we are sharing to assist industry in improving the microbiological safety of powdered infant formula.
The FDA is calling on all members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for the protection of infants. The FDA will continue conducting inspections and working with industry to advance research and regulatory activities included in the prevention strategy to ensure the safety of all infant formula in the U.S. market. In addition to this call to action, Congress recently added new requirements for manufacturers aimed at mitigating supply chain disruptions through mandatory shortage notifications and risk management plans. The agency appreciates the continued collaboration with industry members for improvements made thus far and everyone’s continued efforts to ensure the safety and resiliency of the infant formula supply in the United States.
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