The U.S. Food and Drug Administration recently released the largest and most comprehensive analysis of chemical contaminants in infant formula sold in the United States.
The testing, conducted as part of a broad federal review, examined more than 300 infant formula samples, including powders, ready-to-feed liquids, and concentrated forms. The agency generated more than 120,000 data points while screening for contaminants such as lead, mercury, cadmium, arsenic, pesticides, per- and polyfluoroalkyl substances (PFAS), and phthalates.
Officials said the findings confirm that the U.S. infant formula supply is generally safe, with the majority of samples showing either undetectable or very low levels of contaminants.
“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,” said Robert F. Kennedy Jr. “We will hold manufacturers accountable, and give parents honest, transparent data they can trust. Protecting our children’s health is nonnegotiable.”
The review comes as millions of families rely on formula as a primary or supplemental source of nutrition, even as health experts continue to describe breast milk as the optimal choice when available.
FDA Commissioner Marty Makary said the results offer reassurance while underscoring the agency’s continued oversight.
“You can judge a society by how it treats its most vulnerable members. That’s why we’re doing everything in our power to make sure our babies and infants have safe, high-quality formula options that are backed by a resilient supply chain,” Makary said. “The results of this study are encouraging. We will continue to advance formula innovation and safety for the millions of families who depend on it.”
The agency analyzed 312 samples representing 16 brands, with multiple batches tested. Most products were milk-based, while others included soy and amino acid-based formulas.
Mercury was not detected in 95% of samples, while cadmium and lead were often either absent or present at very low levels. Arsenic appeared more frequently but remained within low ranges across most products. Nearly all samples — 99% — showed no detectable pesticides, and none contained glyphosate or glufosinate.
Testing also found that most PFAS compounds were not present. A small number of samples contained detectable levels of certain PFAS chemicals, typically at extremely low concentrations measured in parts per trillion. Phthalates, used in plastics, were absent in more than half of the samples, with the remainder showing varying but generally low levels.
Federal officials emphasized that small amounts of contaminants can occur naturally in food or enter through environmental exposure during production and sourcing.
Despite the overall findings, the FDA said it will continue additional testing and monitoring. The agency plans to work with manufacturers to reduce contaminant levels further and may establish formal action thresholds.
“As a father, I understand how important it is for parents to trust the safety of the food they give their children. At the FDA, ensuring the health of America’s next generation is vital,” said Kyle Diamantas, Deputy Commissioner for Food. “Through Operation Stork Speed and our Closer to Zero initiative, this testing—the first of its kind—reinforces that infant formula in the U.S. is a safe option for parents and caregivers who rely on it. We will continue working to drive contaminants to as low as possible through rigorous oversight.”
The testing is part of “Operation Stork Speed,” a federal initiative aimed at strengthening the safety, quality, and supply of infant formula. Officials said the effort includes ongoing surveillance of products on the market, as well as new testing for formulas introduced since the initial survey began.
The agency also plans to share results from follow-up testing as part of its transparency efforts and will convene industry leaders in May to discuss improvements to oversight and safety standards.
While the FDA noted that limited testing of human milk also detected some contaminants, it said those results cannot be broadly applied. Breast milk remains the recommended source of infant nutrition when possible.
Officials said the broader initiative prioritizes reducing exposure to contaminants in foods consumed by infants and young children, who are considered more vulnerable due to their size and developing systems.
