Peters’ Bill is in Response to Bacterial Contaminations, Infant Deaths, and Product Recalls That Triggered Nationwide Formula Shortages in Recent Years
WASHINGTON, DC – U.S. Senator Gary Peters (MI) reintroduced bipartisan legislation to help prevent future infant formula shortages. Peters’ bill is in response to the bacterial contaminations at an infant formula manufacturing plant, the deaths of 9 infants, and infant formula recalls that triggered a nationwide shortage in 2022. Peters’ Protect Infant Formula from Contamination Act – which he introduced with U.S. Senator John Hoeven (R-ND) – aims to strengthen the U.S. Food and Drug Administration’s (FDA) oversight of infant formula manufacturing to improve the safety of our nation’s infant formula supply and ensure American families have access to safe, affordable formula.
“As a father and grandfather, I was devastated for the parents who lost their children. Parents deserve to know with complete confidence that the formula they are giving their babies is safe. I’m working to make sure something like that never, ever happens again,” said Senator Peters. “This commonsense bill would help intercept contaminated formula from reaching the shelves in the first place by allowing the FDA to have a hand in testing for dangerous bacteria. Doing so will help protect our children, but also prevent families from facing another nationwide shortage where folks were struggling to both find and afford infant formula.”
Between September 2021 and February 2022, the FDA received reports of infants who were sickened after consuming powdered infant formula products manufactured by a facility in 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. In February 2022, the FDA warned consumers not to use certain products manufactured at this facility and the company issued a voluntary recall. In addition, in 2023, FDA issued warning letters to three additional infant formula manufacturers to improve conditions at their plants. Peters’ bipartisan legislation would improve the FDA’s ability to help prevent future bacterial contaminations and minimize the supply chain disruptions if product recalls do occur.
Peters’ Protect Infant Formula from Contamination Act would take a three-pronged approach to reduce the risk of infant formula contamination from the bacteria Cronobacter sakazakii that triggered a nationwide formula shortage. Specifically, the bill would:
Require infant formula manufacturers to conduct testing for Cronobacter or Salmonella in infant formula marketed for consumption: Under current law, infant formula manufacturers are required to notify the FDA if their product is contaminated, but only if the product has left their control. Knowledge about such incidents would enable the FDA to more effectively and proactively target its inspections, import controls, and finished product testing requirements for manufacturers.
Require infant formula manufacturers to share positive contaminant results with the FDA: The bill would require manufacturers to share contaminant information with the FDA, supporting the FDA’s efforts to quickly identify the strains and origins of contamination, and detect other potentially contaminated products. This requirement would have helped the FDA identify related Cronobacter or Salmonella strains during the contaminations and formula recalls in 2021.
Require infant formula manufacturers to consult with the FDA on how to properly dispose of contaminated products: Bacteria can live and spread across multiple surfaces in the process of removing infected product from a facility. The safe, comprehensive disposal of contaminated products is critical to ensuring that recontamination risks are eliminated and do not impact other product batches. The bill would ensure the highest, science-backed standards and methods of disposal are made available to manufacturers with impacted products.
Additionally, the bill would require the FDA to issue a progress report to Congress on its implementation of the recommendations it provided in the Long-Term National Strategy to improve the safety and security of our nation’s infant formula supply. In January 2025, the FDA released its Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market to secure a safe, consistent, and diversified infant formula supply, addressing vulnerabilities exposed by the 2022 formula shortage. Among other recommendations, the FDA’s strategy calls for the testing authorities included in Peters’ Protect Infant Formula from Contamination Act.
The Protect Infant Formula from Contamination Act is supported by numerous key stakeholders including the Association of Maternal and Child Health, First Focus, Zero to Three, March of Dimes, MomsRising, the Academy of Nutrition and Dietetics, and the Center for Science in the Public Interest.
“As the nonprofit organization leading the fight for the health of all moms and babies, March of Dimes is proud to endorse the Protecting Infant Formula from Contamination Act (PIFCA). This critical legislation would strengthen the U.S. Food and Drug Administration’s (FDA) oversight of infant formula manufacturing, ensuring American families have access to a safe, secure, and affordable formula supply,” said Stacey Y. Brayboy, March of Dimes, SVP Public Policy & Government Affairs. “March of Dimes supports the bill’s comprehensive three-pronged approach to enhance FDA surveillance, improve the safety and security of the infant formula supply chain, and address risks like Cronobacter sakazakii contamination, which has tragically caused infant deaths and recalls. By reducing the likelihood of future shortages and promoting safe manufacturing practices, this legislation is vital to protecting babies and supporting families. We thank Senators Gary Peters and John Hoeven for their leadership and urge Congress to act swiftly to pass this important measure.”
“The Protect Infant Formula from Contamination Act is a crucial step in improving food safety standards for infant formula,” said Livleen Gill, President of the Academy of Nutrition and Dietetics. “The Academy of Nutrition and Dietetics believes it is vital to ensure safe, nutritious formula for families, especially for those returning to work or facing breastfeeding challenges. By implementing a rigorous process to monitor and prevent potential contamination, this legislation would reduce the risk of illness and provide parents with greater peace of mind.”
The Protect Infant Formula from Contamination Act is a sensible step to enhance transparency, safety, and consumer trust by ensuring that manufactures notify the FDA when they find a formula product has been contaminated with harmful bacteria. By passing this law, Congress will help to ensure a swifter, more targeted federal response, enhancing the stability and safety of our infant formula supply,” said Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest.
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