May 20, 2022

FDA Responds to Apparent Shortages of Powdered Infant Formula

The FDA is responding to apparent shortages of powdered infant formula after the issues of Cronobacter contamination at Abbott Nutrition’s facility that made Similac and other brands. The update states that before these products were voluntarily recalled because of reports of infant illnesses, there were supply chain issues associated with the COVID-19 pandemic.

FDA Responds to Apparent Shortages of Powdered Infant Formula

While Cronobacter was found in environmental samples at the Abbott facility, those samples did not match the isolates from two of the infant patients. And the patient isolates did not match each other.

FDA Commissioner Robert M. Califf, M.D. said in a statement, “We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it. Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA. Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products.”

The FDA is taking “significant actions” to help increase the supply of formula in the United States. Other manufacturers are meeting or exceeding capacity levels to meet the current demand. The update also says that more infant formula was purchased in April 2022 than in the month before the recall was issued.

In an update to the investigation of those Cronobacter infections, the FDA states, “The investigation status has been changed to Active (IMG) as this incident is not being managed by a CORE Response Team and FDA established an Incident Management Group (IMG) to manage this investigation. Updates will continue to be provided.”

Meanwhile, to address the apparent shortages of powdered infant formula, the FDA is meeting with these manufacturers to understand their capacity to increase production of different types of formulas and medical foods. The agency is also helping manufactures bring safe product to the market by expediting review of notifications of manufacturing changes. They are also monitoring the status of the infant formula supply, and compiling data on trends for in-stock rates.

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