Senator Peters Announces Bipartisan Legislation to Help Prevent Future Infant Formula Shortages

WASHINGTON, DC – U.S. Senator Gary Peters (MI) introduced bipartisan legislation to help prevent future infant formula shortages. Peters’ bill comes in response to the bacterial contaminations at an infant formula manufacturing plant in Michigan that caused the deaths of 9 infants and infant formula recalls that triggered a nationwide shortage in 2022. Peters’ Protect Infant Formula from Contamination Act (PIFCA) – which he introduced with U.S. Senator John Hoeven (R-ND) – would strengthen the U.S. Food and Drug Administration’s (FDA) oversight of infant formula manufacturing to improve the security of our nation’s infant formula supply and ensure American families have access to safe, affordable formula. Peters recently secured support for the bill from FDA Commissioner Robert Califf at Senate Appropriations Subcommittee hearing.

“Parents need to know with absolute certainty that the formula they’re buying for their babies is safe,” said Senator Peters. “As a parent myself, I’m heartbroken for those parents who lost their children, and I’m committed to making sure something like this never, ever happens again. This commonsense bill would allow the FDA to test infant formula for dangerous contaminants before it hits the shelves to protect our kids and prevent another nationwide shortage like the recent one that put many families in unthinkable situations where they had to scramble to both find and afford infant formula.”  

Between September 2021 and February 2022, the FDA received reports of nine infant deaths 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 — including an additional facility in Michigan — to improve conditions at their plants. Peters’ bipartisan legislation would help the FDA help prevent future bacterial contaminations and minimize supply chain disruptions if product recalls do occur.  

Peters’ Protect Infant Formula from Contamination Act (PIFCA) would take a three-pronged approach to reduce the risk of infant formula contamination from the bacteria Cronobacter sakazakii that caused infant deaths and recalls 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 also require the FDA to issue a progress report to Congress on its implementation of the recommendations it provided in the Immediate National Strategy to improve the safety and security of our nation’s infant formula supply. Following the recall that caused a nationwide infant formula shortage, the FDA issued the Immediate National Strategy in March 2023, which outlined the steps it must take in the short-term to protect the infant formula supply. The FDA is currently in the process of developing a long-term National Strategy to increase the resiliency of the U.S. infant formula supply chain. 

Peters’ Protect Infant Formula from Contamination Act (PIFCA) is supported by numerous key stakeholders including the Association of Maternal and Child Health Programs, 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 an organization dedicated to the well-being of our nation’s infants, the Association of Maternal & Child Health Programs (AMCHP) is pleased to endorse the Protecting Infant Formula from Contamination Act (PIFCA). This bill adopts a comprehensive three-pronged approach to improve the safety of infant formula, specifically addressing the risk of Cronobacter sakazakii contamination,” said AMCHP CEO Terrance E. Moore. “AMCHP supports the bolstered Food and Drug Administration (FDA) surveillance measures outlined inPIFCA to improve the safety and security of the infant formula supply, reduce the likelihood of future shortages, and promote safe infant formula manufacturing activities. Thank you to Senators Gary Peters and John Hoeven for their leadership on this important legislation.” 

“America’s moms and families need and deserve confidence that they will be able to access and afford baby formula that is safe for their infants when they need it,” said MomsRising Executive Director and CEO Kristin Rowe-Finkbeiner. “But that confidence has been badly shaken in recent years, putting massive stress on vulnerable young families. The Protect Infant Formula from Contamination Act(PIFCA) would help solve that problem by improving the safety and security of the baby formula supply, making it less likely we will face contamination or shortages going forward. We thank Senators Gary Peters and John Hoeven for championing this bill. Its passage should be a priority for every member of Congress.” 

“The earliest days of a child’s life are critical for growth and development and good nutrition plays a pivotal role during this period of rapid growth,” said Patricia Cole, Senior Director of Federal Policy for ZERO TO THREE. “We applaud the introduction of the Protect Infant Formula from Contamination Act that would work to ensure baby formula is safe and secure, safeguarding baby’s high-quality nutrition while reducing the likelihood of another formula shortage. The most recent formula crisis caused significant stress for hundreds and thousands of families, most heavily impacting low-income families, families in rural areas, and families of color. The introduction of this bill represents a significant step towards ensuring the safety and quality of infant formula.” 

“It’s unacceptable that our infants are being exposed to dangerous organisms in their food. The commonsense food safety standards in this bill will go a long way towards protecting them,” said Dr. James Kincheloe, Food and Safety Campaign Manager at the Center for Science in the Public Interest. 

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