New contamination test results from the Food and Drug Administration confirm the safety of infant formula in the United States, the agency announced Wednesday.
The FDA tested 312 samples from 16 infant milk brands for contaminants such as heavy metals, pesticides, and “permanent chemicals” known as per- and polyfluoroalkyl substances (PFAS). The agency said most contaminants were undetectable or at very low levels, with levels of lead, mercury, cadmium and arsenic in all samples below federal drinking water standards.
Stephen Abrams, a professor of pediatrics at the Dell School of Medicine at the University of Texas at Austin, said on LinkedIn that the heavy metal results are largely “reassuring” for parents. Abrams, one of the experts at last year’s FDA Roundtable on Infant Formula Safety, urged the FDA to “establish clear U.S. standards for heavy metals in infant formula and a plan and pattern for ongoing evaluation.”
The U.S. government currently has no formal limits on contaminants in infant formula, but Kyle Diamantas, the FDA’s director of human foods, told The New York Times that the agency is working on developing limits.
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“We are testing more infant formula than ever before, and the results are clear: Most products meet high safety standards, but even small amounts of exposure matter to newborns,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement. “We will hold manufacturers accountable and provide parents with honest, transparent data they can trust. Protecting the health of children is non-negotiable.”
The investigation began in 2023 under the Biden administration. Last year, the Department of Health announced Operation Stork Speed, a broad initiative aimed at investigating the quality and improving the supply of infant formula in the United States. This comes after several alarming episodes regarding infant formula, including an outbreak of infant botulism linked to Byheart formula late last year, and a Consumer Reports article that warned that levels of contaminants in some formula were “concerning” based on Environmental Protection Agency drinking water requirements. In a response to the original Consumer Reports article, leading infant formula manufacturer Abbott Nutrition noted that its formula meets requirements set by Europe and Canada.
The FDA noted that 99% of all samples were free of pesticides such as glyphosate and glufosinate, and 95% had PFAS levels below 28 ppt. This is equivalent to one drop in 1,000 Olympic-sized swimming pools.
The agency said it will continue to work with manufacturers to further reduce contaminant levels.
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