The Trump administration announced earlier this month that hundreds of infant formula samples tested for toxic chemicals “meeted high safety standards,” but public health advocates have warned that this claim is contradicted by data showing that the majority were contaminated with dangerous substances such as Pfas and phthalates.
Independent scientists who reviewed the results said the data gaps and contamination raised concerns, but added that the test showed some bright spots and praised the U.S. Food and Drug Administration for expanding its testing program and publishing the results.
The statement from FDA officials appears to partially contradict a 2014 FDA paper detailing how trace amounts of chemicals detected in current tests can pose a serious risk to newborns, who are small and still developing and have a higher food-to-weight ratio than adults.
In a statement announcing the results, Health and Human Services Secretary Robert F. Kennedy Jr. said: “We have tested more infant formulas than ever before, and the results are clear. Most products meet high safety standards, but even small amounts of exposure are problematic for newborns.”
“We will hold manufacturers accountable and give parents honest, transparent data they can trust. Protecting the health of children is non-negotiable,” Kennedy added. The release does not provide details on next steps.
Under the Kennedy administration, the FDA launched Operation Stork Speed, testing 300 samples of infant formula for Pfas, phthalates, lead, pesticides, mercury, and other hazardous substances found with some regularity in infant formula.
PFA and phthalates are among the most toxic man-made chemicals and the most widely detected. At least half contained Pfos. Pfos is one of the most dangerous Pfas compounds, and the federal government has previously determined that exposure levels in drinking water are unsafe.
About half of the samples also contained phthalates, which are plasticizers, and relatively low levels of lead were detected in some samples. Some samples also contained chlorpyrifos, a highly toxic pesticide that the EPA was planning to ban in 2021. The industry successfully filed a legal challenge to reverse the decision.
“I’m encouraged that[the FDA]is moving to test for other things,” said Maricel Maffini, an independent consultant whose regulatory work aims to pressure the FDA to strengthen consumer protections, but added that she is alarmed by the prevalence of endocrine-disrupting chemicals such as phthalates and Pfas.
These pose a particular risk because even low doses can affect children’s hormones during critical stages of development, causing immediate or subsequent developmental, reproductive, neurological, and other health effects.
“There is no truly safe amount of endocrine disruptors,” Maffini said. “The overarching argument seems to be that in small doses, chemicals don’t do anything or aren’t very dangerous, but that goes against everything we know about how these chemicals do and can affect the body.”
Significant gaps also exist in FDA testing data. Since the product name is not listed, it is unclear which products do not contain chemicals. However, authorities did not say whether the samples contained multiple contaminants. Although little research exists on exposure to multiple chemicals, it is generally believed that there are additive or synergistic effects that make chemicals even more dangerous.
The FDA writes that 95% of Pfos levels are less than 2.9 parts per trillion (ppt). Drinking water limits are set at 4 parts per trillion, but that may not protect infant formula, public health advocates say. Extensive research has also linked low levels of Pfas exposure in utero or during infancy to decreased immunity.
The FDA’s Pfas results topline states that of the 30 Pfas compounds tested, “most Pfas compounds (25 of 30) were not detected in any of the samples.” However, the majority of samples still contained some Pfa, most at levels of concern to independent experts.
Tasha Stoiber, a scientist with the nonprofit Environmental Working Group, said that many Pfas are in dry formulations, which must be mixed with water that can contain Pfas, making the products more toxic.
“We know that very low levels of exposure are associated with health effects, and … newborns are at this critical stage of development,” Stoiber said. Teuber added that short-chain PFA, the type of compound used throughout the food system, is included in the formula.
“If you think about this at a high level, this is what happens when Pfas is widely used,” she said.
The source of phthalates detected in 46% of samples could be plastic food packaging or processing equipment. This chemical gives plastic its elasticity, but it also easily washes into food and drink. Despite the risks, the FDA has not set enforceable limits on phthalates, established safe levels for daily intake, and established few other guidelines related to them.
FDA Commissioner Marty McCulley called the results “encouraging.”
“You can judge a society by how it treats its most vulnerable people,” McCurry says. “That’s why we’re committed to providing babies and toddlers with safe, high-quality formula options backed by a strong supply chain.”
Tom Neltner, director of the nonprofit group Unleaded Kids, said lead and other metal contamination in infant milk has long been a problem, and the latest tests show relatively low levels compared to the past. This shows there is public and political pressure on the industry to act, he said, but added that the FDA’s snapshot of prescriptions alone is not enough to ensure safety.
“We need continued transparency,” Neltner said.
While industry regularly tests formulas, the FDA claims it has little authority to view them, but Neltner said that’s not true. New laws introduced in California and Vermont would require baby formula manufacturers to share test results with the public. Neltner praised the administration’s expanded testing and said the FDA’s next step is to set an action level for lead, which doesn’t exist yet.
“The next step cannot be declared safe because there is no guarantee that companies will maintain this level,” Neltner said.
