The Food and Drug Administration has released an update on its work to develop a strategy to help prevent Cronobacter sakazakii illnesses related to powdered infant formula.
The agency is working on the strategy as part of its response to an outbreak of illnesses and the subsequent temporary closure of the Abbott Nutrition production plant in Sturgis, MI. The closure led to a nationwide shortage of infant formula that lasted for months.
In response to the situation, the FDA initiated the development of a prevention strategy, with the draft released in November 2022.
“At the time, the FDA committed to using the strategy to guide its work to enhance the safety of powdered infants, including through engagements with the infant formula industry and other stakeholders,” according to an FDA statement. “These engagements further supported the strategy laid out, and at this time, the strategy will continue forward without further actions being added. As more information becomes available, the FDA may add additional actions over time.”
Infant formula firms are now required to develop, maintain, and implement, as appropriate, risk management plans to identify and evaluate risks to the supply of critical food, such as infant formula, and ways to mitigate such risks. This is a new requirement mandated by Congress in the Food and Drug Omnibus Reform Act of 2022.
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