November 15, 2022
The U.S. Food and Drug Administration has released an outline of a prevention strategy under development to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula.
This prevention strategy is being developed following a large-scale recall of powdered infant formula earlier this year. Powdered infant formula was recalled because FDA investigators found insanitary conditions in a manufacturing facility, which possibly contributed to Cronobacter sakazakii infections in four infants. The recall added further pressure to an already stressed supply-chain, making it difficult for caregivers of infants to find certain powdered infant formula products earlier this year. While the supply of infant formula products has been steadily increasing and the FDA continues to work with manufacturers to maximize production and fill store shelves, this strategy will outline our path toward enhancing the safety of these products.
Food safety is a shared responsibility and stakeholder engagement is critical to inform our collective next steps. The outline released today is intended to guide discussions during further development of FDA’s strategy to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. In the coming weeks, teams from across the FDA will be meeting with stakeholders to further discuss, hear their ideas, and finalize the prevention strategy. Following this engagement, we intend to release an updated summary of the powdered infant formula strategy on FDA.gov, just as we did with those, we recently released for bulb onions and imported enoki and wood ear mushrooms. The updated summary will outline where we are and where we are going in our efforts to enhance the safety of powdered infant formula and will continue to be updated over time as more information is learned.
For More Information:
- Outline of FDA’s Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula