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.

The actions that have been taken to date to advance the goals of the FDA’s strategy, include: 

  • Continuous collaboration with industry, coalitions, academia, and consumer groups to better understand and explore ways to enhance the safety of powdered infant formula.
  • Issuance of a letter to the powdered infant formula industry to share current safety information and a call to industry to take prompt action to improve processes related to the safe production of powdered infant formula.
  • Initiation of hiring to establish a dedicated cadre of investigators to conduct infant formula inspections. 
  • Initiation of hiring of staff to support the new Office of Critical Foods. 
  • Supporting the Council of State and Territorial Epidemiologists (CSTE) position on elevating Cronobacter to a nationally notifiable disease, which was successfully adopted by the CSTE on June 29, 2023.
  • Updating and reorganizing infant formula related materials on to provide both consumers and industry with more accessible information, including:
  • Initiating work with the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to address knowledge gaps regarding Cronobacter sakazakii. 

“While these actions are specific to work guided by the prevention strategy, the FDA has continued to undertake additional steps to enhance its regulatory oversight of the infant formula industry. This includes the recent issuance of three warning letters to infant formula firms in August 2023. The letters reinforce the importance of instituting and maintaining appropriate corrective actions when pathogens are detected to ensure compliance with the FDA’s laws and regulations,” according to the FDA”s statement.

In addition, the FDA is working to strengthen the infant formula market, including through the issuance of an Immediate National Strategy initiating work with the National Academics of Science, Engineering, and Medicine to help inform long-term plans.

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