FDA Provides Update on the Cronobacter Prevention Strategy in Powdered Infant Formula
Wednesday, September 20, 2023
FDA Baby Formula risks
  • Today, FDA announced an update on its work to advance its strategy to help prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula, including:

    • 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 FDA.gov 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

  • The updated prevention strategy webpage includes a full list of actions that have been taken to date. In addition, FDA has continued to undertake additional steps to enhance its regulatory oversight of the infant formula industry, including the recent issuance of three warning letters to infant formula firms in August 2023 and requirement that manufacturers to develop, maintain and implement risk management plans to identify and evaluate risks to the supply of the critical food, such as infant formula, and ways to mitigate such risks, as mandated by Congress.

  • Keller and Heckman will continue to monitor and report on issues relating to infant formula.


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