Hoeven unveils bill to strengthen infant formula safety

Working to ensure that American families have access to safe infant formula in the aftermath of recalls due to contamination, U.S. Sen. John Hoeven (R-ND) introduced a bipartisan bill on June 3 to improve the security of U.S. infant formula supply.

In 2022, bacterial contaminations at a Michigan infant formula manufacturing plant caused the deaths of nine babies and led to recalls that resulted in nationwide shortages of infant formula.

Rep. Hoeven’s legislation, the Protect Infant Formula from Contamination Act (PIFCA), S. 4436, would strengthen U.S. Food and Drug Administration (FDA) oversight of infant formula manufacturing.

The legislation was introduced on June 3 with bill sponsor U.S. Sen. Gary Peters (D-MI) and is under consideration in the Senate Health, Education, Labor, and Pensions Committee.

“American families shouldn’t have to worry about the safety and availability of something as vital as baby formula,” Sen. Hoeven said.

S. 4436, if enacted, would impose a strategy to reduce the risk of infant formula contamination from the bacteria Cronobacter sakazakii or Salmonella by requiring infant formula manufacturers to conduct testing. Manufacturers would be required to share positive contaminant results with the FDA and also consult with the FDA on how to dispose of contaminated products, a bill summary said.

According to Sen. Hoeven’s office, infant formula manufacturers are currently required to notify the FDA if their product is contaminated, but only if the product has left their control.

“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.”

The legislation would also require the FDA to report to Congress on the implementation of its Immediate National Strategy recommendations to improve the safety and security of the U.S. infant formula supply.