Yesterday, on March 8, 2023, the U.S. Food and Drug Administration (FDA) sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula, asking for them to share current safety information and to take action to improve processes for the protection of infants.

Last year, safety concerns at one of the largest infant formula manufacturing facilities in the U.S. prompted a nationwide recall and temporary pause in production, leading to a national infant formula shortage.  Since then, FDA has issued multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula through enforcement discretion.  The Agency has also developed a cronobacter prevention strategy, enhanced inspection activities, increased engagement with the industry, and has pursued regulatory action in some cases.

In the recent months, FDA food safety staff have been meeting regularly with the powdered infant formula manufacturers to further develop the prevention strategy to help prevent cronobacter illness.  The letter reflects the information gained during these meetings, as well as the latest available science.

In its update, FDA calls 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 infant protection.  FDA will continue to inspect and work with the industry to advance research and regulatory activities included in the prevention strategy.