Recent contamination tests by the Food and Drug Administration (FDA) have confirmed the safety of infant formula available in the U.S., the agency announced on Wednesday.
The FDA has conducted tests on 312 samples from 16 different brands of infant formula, checking for contaminants such as heavy metals, pesticides, and per- and polyfluoroalkyl substances (PFAS), commonly referred to as “forever chemicals.” The agency reported that the vast majority of samples showed undetectable or minimal levels of contaminants, including lead, mercury, cadmium, and arsenic, all of which were below federal drinking water standards.
Steven Abrams, a pediatrics professor at Dell Medical School, University of Texas at Austin, commented on LinkedIn that the findings on heavy metals are largely “reassuring” for parents.
Abrams, who participated in the FDA roundtable on infant formula safety the previous year, emphasized the need for FDA guidance on future testing protocols: what will be tested, the frequency of testing and reporting, and the management of high-value results.
Currently, the U.S. government has not set formal limits for contaminants in infant formula. However, Kyle Diamantas, head of human foods at the FDA, mentioned to The New York Times that the agency is working to establish those limits.
Health and Human Services Secretary Robert F. Kennedy, Jr., stated, “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.” He added that manufacturers will be held accountable, and parents will receive honest and transparent data. “Protecting our children’s health is nonnegotiable,” he said.
This extensive survey began in 2023 during the Biden administration. The following year, the health department initiated Operation Stork Speed, aimed at enhancing the quality and supply of infant formula in the country. This initiative followed troubling incidents, including an outbreak of infant botulism linked to ByHeart formula and a Consumer Reports article that highlighted concerning levels of contaminants in some formulas, based on EPA drinking water standards. Abbott Nutrition, a major manufacturer, noted that its formulas meet the standards set by Europe and Canada.
Brian Ronholm, head of food policy for Consumer Reports, expressed disappointment via email if the FDA does not take meaningful regulatory action, such as setting public health-based limits for contaminants. “Their tests and our tests clearly demonstrate that non-detect levels are feasible,” he stated.
Moving forward, Abrams suggested the FDA should compare its testing with individual manufacturers’ results to ensure accuracy. He also recommended testing various types of formulas, including imported, organic, and those made from different milk sources, to identify any patterns in elevated contaminant levels over time.
The FDA reported that 99% of the samples were pesticide-free, including no glyphosate and glufosinate, and 95% had PFAS levels at or below 28 parts per trillion. The EPA’s drinking water limits for PFOA and PFOS, two common PFAS chemicals, are set at 4 parts per trillion.
The agency plans to continue collaborating with manufacturers to further reduce contaminant levels.
This story has been updated.
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