Constituent Update

September 20, 2023

The U.S. Food and Drug Administration (FDA) is providing an update on its work to advance its strategy to help prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula.

A draft outline of the prevention strategy was first released in November 2022 in response to the infant formula shortage earlier that year following a large-scall recall and temporary shutdown of one of the nation’s largest infant formula manufacturing facilities prompted by safety concerns at the facility. At the time, the FDA committed to using the strategy to guide its work to enhance the safety of powdered infant including through engagements with the infant formula industry and other stakeholders. These engagements further supported the strategy that was laid out, and at this time the strategy will continue forward without further actions being added. The FDA may add additional actions over time as more information is learned.

Today, the agency is providing an update on the significant actions that have been taken to advance the goals of the strategy, 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:
  • Infant Formula
  • Cronobacter sakazakii
• Initiating work with the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to address knowledge gaps regarding Cronobacter sakazakii. 

The updated prevention strategy webpage includes a full list of actions that have been taken to date. 

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.

In addition, the FDA is continuing to advance work to strengthen the resiliency of the infant formula market, including through the issuance of an Immediate National Strategy, initiating work with the National Academies of Sciences, Engineering, and Medicine to help inform long term plans for strengthening the infant formula market and through ongoing work to enhance and expedite infant formula reviews. Infant formula firms are also now required to develop, maintain and implement, as appropriate, 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. This is a new requirement mandated by Congress in the Food and Drug Omnibus Reform Act of 2022. 

The FDA is committed to continuing its work to strengthen the safety, resiliency, and oversight of the infant formula industry and will continue to provide updates as they become available.