A new federal analysis has offered reassuring findings regarding the safety of infant formula in the U.S., reporting “reassuringly low levels” of heavy metals, pesticides, and other potential contaminants. Federal health officials released the findings on Wednesday.
The comprehensive review, conducted as part of the Food and Drug Administration’s Operation Stork Speed project, was described as the “largest and most rigorous” to date. It concluded that the nation’s infant formula supply is “safe,” a sentiment echoed by both agency officials and independent experts.
“There’s no reason not to use any available formula” in the U.S., stated Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, who reviewed the study’s findings.
Between 2023 and 2025, FDA officials meticulously tested over 300 samples of commercial infant formula. The extensive screening targeted heavy metals, including lead, arsenic, cadmium, and mercury, alongside pesticides, phthalates (chemicals found in plastics), and PFAS, commonly known as “forever chemicals.”
The agency reported that levels of all detected contaminants were either undetectable or very low. Specifically, any heavy metals found were well below the U.S. Environmental Protection Agency’s limits for drinking water. Pesticides were not detected in 99% of samples, and the FDA found no traces for 25 of the 30 PFAS compounds tested.
While outside experts largely concurred with the government’s assessment, acknowledging the natural occurrence of small amounts of substances like heavy metals in the environment, some raised concerns about synthetic compounds.
“These chemicals are completely synthetic,” noted Dr. Sheela Sathyanarayana, a pediatrics professor at UW Medicine and the Seattle Children’s Research Institute. “The detection of some of these compounds at all is concerning.” She emphasized the ongoing need for further monitoring of infant formula and the broader U.S. food supply.
Operation Stork Speed was initiated by the Trump administration in March 2025, with a commitment to review safety and quality standards for infant formula in the U.S. for the first time in decades. This initiative built upon previous FDA efforts to scrutinize substances like heavy metals in infant foods, which Dr. Abrams highlighted can impact brain development, learning, and behavior in children.
Currently, the FDA lacks enforceable limits for heavy metals in infant formulas, a contrast to regulations in the European Union, Canada, and Australia. Consumer advocacy groups have long urged the FDA to establish stringent limits for contaminants. Last year, a Consumer Reports analysis of 41 U.S. infant formulas suggested “worrisome levels” of heavy metals and other contaminants, though it used its own level of concern, set below European Union standards. That report garnered significant public attention, leading some parents to discontinue using commercial formula, even when medically necessary, Abrams observed.
Dr. Abrams advocated for the FDA to continue its monitoring of infant formula for contaminants and to transparently share the results. Abbott, a major formula manufacturer, also called on the FDA to establish scientific standards for contaminants.
“We believe that producing infant formula at scale in the U.S. is a matter of national security,” said Abbott spokesman John Koval in an email. “These results affirm the safety of our current domestic supply.”