The U.S. Food and Drug Administration is annoucing a series of actions aimed at improving the quality, safety, and nutritional adequacy of infant formula, responding to growing concerns over contamination and supply chain resilience.
The FDA's new initiative, “Operation Stork Speed,” includes increased testing for heavy metals and contaminants, a nutrient review process, and encouragement for companies to develop new infant formulas.
“The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” said U.S. Health Secretary Robert F. Kennedy Jr.
As part of this initiative, the FDA will focus on eliminating harmful chemicals in infant formula, an issue that has gained attention following reports of arsenic and lead contamination in some powdered formula products.
A recent investigation by Consumer Reports found potentially harmful levels of heavy metals in several infant formula brands after testing 41 different types.
Brian Ronholm, director of food policy at Consumer Reports, welcomed the FDA’s initiative but cautioned that its effectiveness will depend on proper execution. “We look forward to seeing how the FDA intends to implement the plan and hope that the FDA is provided adequate resources and staffing to actually follow through with these promises,” Ronholm said.
Strengthening the supply chain
Beyond improving safety, the FDA is also working with companies to increase transparency, improve labeling, and ensure a consistent and reliable supply of infant formula.
These steps are designed to prevent another formula shortage crisis, like the one that occurred in 2022, when Abbott Laboratories, the nation’s largest baby formula manufacturer, recalled several Similac products following reports of bacterial infections in infants. The incident led to nationwide shortages and raised concerns about the FDA’s slow response and oversight failures.
Following the crisis, the FDA restructured its food division and has since faced pressure to strengthen regulations and improve industry accountability.
With Operation Stork Speed, health agencies hope to rebuild trust and protect the nation's most vulnerable infants by ensuring that infant formula remains safe, nutritious, and readily available for families who depend on it.