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  1. FDA Voices

Focusing on Prevention to Safeguard Infant Formula

Woman looking at a shelf stocked with a variety of Infant Formula.

By: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Nutrition

Over this last year, some families around our country faced challenges finding infant formula, a product that serves as the sole source of nutrition for many infants in the U.S. What started with reports of illnesses in infants led to a for-cause inspection of a major formula manufacturing facility. Environmental sampling in that facility by the U.S. Food and Drug Administration identified multiple strains of Cronobacter sakazakii, a potentially harmful bacteria to infants, and other insanitary conditions that prompted a large-scale voluntary recall and pause in production to safeguard public health. These actions further stressed the infant formula supply chain already strained by the COVID-19 pandemic, creating hardships for parents and caregivers who rely on these products to feed their babies and loved ones. 

Susan T. Mayne, Ph.D.
Susan T. Mayne, Ph.D.

Recently, the FDA released an Evaluation of the Agency’s Infant Formula Response, which notes various opportunities for improvement, but at the heart of this particular issue is safety. The interconnection between food safety and nutrition isn’t always readily apparent, but at the FDA it is central to our mission. People in this country should have confidence that their food is both safe and nutritious. Unfortunately, throughout the infant formula situation, we have witnessed what can happen when safety falters: the availability of nutritious foods can as well. 

The FDA has and continues to work with infant formula manufacturers to maximize production to fill shelves, and we have taken steps to allow for safe and nutritious infant formulas that were not previously in the U.S. market to enter, adding greater resilience to the infant formula supply chain. Beyond these actions, which are focused on increasing supply, the FDA is taking additional steps to assure the public that infant formula is and will remain safe.

This fall, the FDA announced a new approach called Prevention Strategies to Enhance Food Safety. These strategies are affirmative, deliberate approaches undertaken by the agency in partnership with stakeholders to help limit or prevent future outbreaks and illnesses linked to certain FDA-regulated foods. Yesterday, we published an outline of a prevention strategy under development to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. This outline is intended to guide discussions with stakeholders over the next several months as we further develop the strategy. Stakeholder engagement is an important part of informing our collective next steps. In the coming weeks, teams from across the FDA will be meeting with stakeholders to further discuss, hear their ideas, and finalize the prevention strategy. Following this engagement, an updated strategy summary will be posted on FDA.gov.  

The prevention strategy will be updated as we learn more including through efforts to fill knowledge gaps in the scientific understanding of Cronobacter. One such effort is a charge being advanced through the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to gain scientific insight on possible industry and public health interventions to address Cronobacter infections associated with powdered infant formula. NACMCF held a virtual public meeting yesterday during which a new charge was presented by the FDA to address the following questions: 

  • What is the current prevalence and level of Cronobacter contamination in powdered infant formula and other foods in the U.S. market? 
  • What factors (e.g., virulence factors, host factors, dose of exposure) place an infant at greater risk for Cronobacter infection and serious adverse health consequences or death?
  • What food safety management practices (e.g., facility and equipment design, hygienic zoning and packaging, preventive controls, verification activities) should manufacturers of powdered infant formula employ to further reduce the risk of Cronobacter contamination of formula and/or the production environment?  
  • How can food safety messaging be improved for infant care providers, with emphasis on use of sterile, ready-to-use formulas for infants at greatest risk and safe infant formula preparation and storage for infant formula in general?

Addressing these knowledge gaps will add scientific insight and expertise to the public dialogue on the safety of infant formula and further inform the prevention-focused efforts underway. 

Preventing the next foodborne illness from happening will require all parties involved in the food chain to be vigilant. Through our prevention strategies, the FDA is eager to engage with industry and other partners in a holistic approach to preventing foodborne illness, especially for infants and young children, who are among the most vulnerable populations to these illnesses. 

For more information or to be part of the discussion, contact: FoodSafetyPreventionStrategies@fda.hhs.gov

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