New contamination testing results from the Food and Drug Administration confirm the safety of infant formula in the U.S., the agency said Wednesday.
The FDA tested 312 samples from 16 infant formula brands for contaminants like heavy metals, pesticides, and the “forever chemicals” known as per- and polyfluoroalkyl substances, or PFAS. The vast majority had undetectable or very low levels of contaminants, the agency said, with levels of lead, mercury, cadmium, and arsenic coming in below federal requirements for drinking water across all samples.
The results on heavy metals are largely “reassuring” for parents, Steven Abrams, a professor of pediatrics at Dell Medical School at the University of Texas at Austin, said on LinkedIn.
Next, “what we need is guidance from the FDA on what they’re going to test, how often they’re going to test, how often they’re going to report it, and how they’re going to handle values that are high,” Abrams, who was one of the experts at the FDA roundtable on infant formula safety last year, told STAT.
The U.S. government does not currently have formal limits for contaminants in infant formula, though Kyle Diamantas, the head of human foods at FDA, told The New York Times the agency is working to develop them.
“We tested more infant formula than ever before, and the results are clear: most products meet a high safety standard — but even small exposures matter for newborns,” Health and Human Services Secretary Robert F. Kennedy, Jr., said in a statement. “We will hold manufacturers accountable, and give parents honest, transparent data they can trust. Protecting our children’s health is nonnegotiable.”
The survey began in 2023, under the Biden administration. Last year, the health department announced Operation Stork Speed, a broader initiative aimed at examining the quality and improving the supply of infant formula in the U.S. It came after several worrisome episodes concerning infant formula, including an outbreak of infant botulism linked to ByHeart formula late last year and a Consumer Reports article that flagged “concerning” levels of contaminants in some formulas, based on Environmental Protection Agency requirements for drinking water. Major infant formula manufacturer Abbott Nutrition noted in its response to the original Consumer Reports story that its formulas meet the requirements established by Europe and Canada.
“It would be disappointing if the FDA doesn’t proceed with any meaningful regulatory action, such as establishing public health-based limits for contaminants,” Brian Ronholm, head of food policy for Consumer Reports, said via email. “Their tests and our tests clearly demonstrate that non-detect levels are feasible.”
Going forward, the FDA should also compare their testing against individual manufacturers’ results in order to ensure the accuracy of manufacturers’ techniques, Abrams said. He also recommended the FDA test the many different types of formula on the market, including imported and organic varieties and those made from cow’s milk versus goat’s milk. “Over a long period of time, we want to know what the pattern is” if contaminant levels are elevated across any particular subset of formulas, he said.
The FDA noted that 99% of all samples contained no pesticides, including glyphosate and glufosinate, and that 95% had PFAS levels at or below 28 parts per trillion. The EPA drinking water limits for PFOA and PFOS, two of the most common types of forever chemicals, are 4 parts per trillion.
The agency said it would continue working with manufacturers to further lower levels of contaminants.
This story has been updated.
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