Committee Unanimously Passes Peters’ Bipartisan Bill to Help Prevent Infant Formula Shortages

WASHINGTON, DC - Bipartisan legislation introduced by U.S. Senator Gary Peters (MI) to prevent future shortages of infant formula has unanimously passed the Senate Health, Education, Labor, and Pensions (HELP) Committee. The Protect Infant Formula from Contamination Act would strengthen the U.S. Food and Drug Administration's (FDA) oversight of infant formula manufacturing to help ensure our nation's supply of infant formula is safe and affordable for American families.

"As a father and grandfather, there is nothing more important than keeping our kids safe and healthy. Parents deserve the peace of mind to know the formula they are giving their babies is safe," said Senator Peters. "This commonsense bill would help ensure contaminated formula doesn't reach the shelves in the first place by allowing the FDA to have a stronger hand in testing for dangerous bacteria. Doing so will protect our children and also help prevent another nationwide shortage like we've seen in recent years where folks struggled to both find and afford infant formula."

Peters reintroduced this bill with U.S. Senator John Hoeven (R-ND). The bill now advances to the full Senate.

"American families need to have access to a safe, reliable supply of infant formula. Shortages in recent years have shown that stronger safeguards and improvements are needed to maintain a stable and secure supply of this crucial product," said Senator Hoeven. "Our legislation, which has now been approved by the Senate HELP Committee, strengthens the infant formula market by improving protection against contamination and bolstering the supply chain to prevent future 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. 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. While progress has been made to restore the safety of products made at the facilities, additional oversight remains needed to prevent future contaminations and shortages. 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.

To prevent future contamination, Peters' Protect Infant Formula from Contamination Act 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.

Furthermore, the legislation 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.

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