02.05.25

Hoeven, Peters Introduce Legislation to Help Ensure Access to Safe Infant Formula, Prevent Shortages

WASHINGTON – Senators John Hoeven (R-N.D.) and Gary Peters (D-Mich.) introduced bipartisan legislation to help prevent future infant formula shortages. The senators’ bill comes in response to bacterial contamination 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.

“Access to safe infant formula is essential for families across the U.S., and as shortages in recent years have demonstrated, improvements are needed to ensure our nation continues to have a secure supply of this important product,” said Senator Hoeven. “Our legislation would build greater resiliency into the infant formula market, helping to protect against contamination and bolstering supplies to prevent future shortages.”

“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.”

The Protect Infant Formula from Contamination Act (PIFCA) would take a three-pronged approach to reduce the risk of infant formula contamination. Specifically, the bill would: 

  • Strengthen safety reporting and ensure timely corrective action.
    • The bill requires infant formula manufacturers to conduct testing for Cronobacter or Salmonella in infant formula marketed for consumption.
    • The legislation also requires manufacturers to notify FDA within one business day of detecting contamination, while setting timelines for investigation and corrective action.
    • This improves upon current law, under which manufacturers are only required to notify the FDA if the product has left the company’s control.
  • Enhance market resiliency.
    • The FDA would be required to monitor and quarterly report on the in-stock rates of infant formula, as well as work with the U.S. Department of Agriculture and other agencies to ensure markets can meet demand over the long term.
  • Increase accountability and consultation.
    • The FDA would be required to issue a progress report to Congress on implementation of the long-term national strategy that it developed after the 2022 recall and shortage.
    • The bill would also require FDA to consult with industry on contamination mitigation best practices and ways to maximize infant formula supply.

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