Hoeven, Peters Protect Infant Formula From Contamination Act Approved By Senate Help Committee

WASHINGTON - Senators John Hoeven (R-N.D.) and Gary Peters (D-M.I.) announced that their bipartisan legislation to help prevent future infant formula shortages passed out of the Senate Committee on Health, Education, Labor and Pensions (HELP) by a vote of 22-0 and will move to the Senate floor. 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 the U.S. infant formula supply and ensure American families have access to safe formula.

"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."

"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."

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 will:

• 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 and recommendations that it developed after the 2022 recall and shortage.
  • The bill would also require FDA to consult with industry on contamination mitigation best practices, including those associated with botulism, and ways to maximize infant formula supply.

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