06.06.24

Hoeven, Peters Introduce Legislation to Help Prevent Future Infant Formula Shortages

WASHINGTON – U.S. Senators John Hoeven (R-N.D.) and Gary Peters (D-Mich.) this week introduced bipartisan legislation to help prevent future infant formula shortages. The senators’ 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. The legislation would strengthen U.S. Food and Drug Administration (FDA) oversight of infant formula manufacturing to improve the security of U.S. infant formula supply and ensure American families have access to safe formula. As Ranking Member of the Senate Agriculture Appropriations Committee, Hoeven recently raised this priority with FDA Commissioner Robert Califf and secured his support for the bill.

“American families shouldn’t have to worry about the safety and availability of something as vital as baby formula,” said Senator Hoeven. “The recent formula shortage caused unnecessary stress for parents and families, which is why we are introducing this bipartisan legislation. Our bill makes important reforms, including requiring that harmful contaminants found during testing be quickly reported to the FDA, and making sure the FDA acts timely to work with companies to resolve the situation, preventing shortages and better ensuring families have access to safe infant formula.”

“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.”  

The 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, which 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 target its inspections, import controls, and finished-product testing requirements more effectively and on a proactive basis.
  • Require infant formula manufacturers to share positive contaminant results with the FDA.
  • Require infant formula manufacturers to consult with the FDA on how to properly dispose of contaminated products. 
  • Require the FDA to report to Congress on its implementation of the Immediate National Strategy recommendations to improve the safety and security of U.S. infant formula supply.
    • Following the 2022 recall and shortage, the FDA issued the Immediate National Strategy, which outlined the steps it must take in the short-term to protect the infant formula supply.
    • The FDA is also currently in the process of developing a long-term National Strategy to increase the resiliency of the U.S. infant formula supply chain. 

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