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  1. New Era of Smarter Food Safety

Outline of FDA’s Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula

Infant Formula

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Cronobacter sakazakii is a pathogen found naturally in the environment that can enter manufacturing facilities and home environments on hands, shoes, and other contaminated surfaces.

Cronobacter sakazakii is especially good at surviving in dry foods, like powdered infant formula, powdered milk, herbal teas, and starches. For most people it is harmless, but it can be life threatening for infants younger than two months, infants who are born prematurely, and for infants who have weakened immune systems.

Overview of recent Cronobacter sakazakii illnesses and contamination of powdered infant formula

Between September 2021 and February 2022, the U.S. Food and Drug Administration (FDA) received complaints about four cases of illness or death in infants who consumed powdered infant formula. After learning that each of these infants consumed powdered infant formula products manufactured by Abbott Nutrition in Sturgis, Michigan, the FDA initiated an onsite inspection at the facility and commenced an investigation that revealed insanitary conditions, including the presence of five different strains of Cronobacter sakazakii within the facility. However, those samples did not genetically match the available clinical isolates from the two case-patients for whom whole genome sequencing (WGS) results were available or any other clinical isolates in the limited number of Cronobacter sakazakii isolates in the National Center for Biotechnology Informatics (NCBI) database. And the two case-patients’ isolates didn’t match each other. While the FDA was unable to determine whether the infants became sick from the firm’s product or contamination by other means, these findings raised serious concerns about the safety of the powdered infant formula and other products produced at this facility. On Feb. 17, 2022, the FDA warned consumers not to use certain products manufactured at this facility.  That same day, Abbott Nutrition issued a voluntary recall of certain infant formula products manufactured in Sturgis, Michigan, and temporarily ceased production to safeguard public health while corrective actions were taken.

Typically, the Centers for Disease Control and Prevention (CDC) receives 2-4 reports of severe Cronobacter infections in infants annually from health departments across the country. Public health investigations primarily link these infections to formula contamination during preparation. Although during recent investigations the FDA was unable to determine whether the infants became sick from contaminated product or contamination by other means, the agency has identified opportunities to enhance the safety of powdered infant formula, which are reflected in the strategy outlined below.

Outline of FDA’s strategy to help prevent future illnesses linked to consumption of powdered infant formula

The outline below is intended to guide discussions during further development of FDA’s strategy to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. Stakeholder engagement and feedback is central to development and implementation of this strategy. Over the next several months the Agency intends to work with stakeholders to finalize this strategy. Following this engagement an updated strategy summary will be posted on FDA.gov.

Below is an outline of the FDA’s prevention strategy to help prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula:

  • Collaborate with stakeholders to better understand best practices in the manufacturing of powdered infant formula and what could be done to enhance safety.
  • Strengthen regulatory activities and current systems for effective oversight of powdered infant formula, including:
    • Consider whether to establish a dedicated cadre of investigators to conduct infant formula inspections.
    • Explore realigning staff across the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs to better support regulatory oversight of infant formula. 
    • Review and update the Infant Formula Compliance Program, as needed, to reflect current science on Cronobacter, and ensure investigators and compliance officers are equipped with the tools and resources needed to enable a consistent and comprehensive approach to inspections of infant formula manufacturing facilities and compliance activities.
    • Provide additional education/training to FDA regulatory staff on inspecting powdered infant formula manufacturing facilities.
  • Review and update current guidance and rules applicable to the production of powdered infant formula, as appropriate.
  • Evaluate current testing requirements and determine whether improvements might be appropriate to enhance the safety of finished product.
  • Continue developing and improving communications for consumers about safe formula preparation and storage.
  • Work with federal, state and local partners to strengthen the ability of public health officials and firms to identify and investigate illnesses of Cronobacter spp. including increased genomic surveillance and supporting elevation of Cronobacter sakazakii infection among infants as a nationally notifiable disease.
  • Conduct and support research to help fill knowledge gaps in the scientific understanding of Cronobacter.  Such research will improve the public health community’s ability to help protect the health of powdered infant formula consumers and will drive improvements in industry practices that can enhance the safety of these products. For example, FDA will collaborate with the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to enhance our understanding of, and gain key insights and recommendations on, Cronobacter.

Through development and implementation of this strategy the FDA seeks to:

  • Broaden scientific knowledge and understanding of Cronobacter sakazakii and public health interventions for controlling it.
  • Improve oversight of safe production of powdered infant formula.
  • Enhance communications and engagement with industry, consumers, federal, state, local, and other public health partners about infant formula safety.

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