FDA Analysis Says Infant Formula Supply Is Safe After Testing for Contaminants

A new analysis of chemicals in U.S. infant formula found reassuringly low levels of heavy metals, pesticides, and other potential contaminants, federal health officials said Wednesday.

The review was conducted as part of the Food and Drug Administration’s (FDA) Operation Stork Speed project — billed as the “largest and most rigorous” to date. It found that the infant formula supply is safe, agency officials and outside experts said.

“There’s no reason not to use any available formula” in the U.S., said Steven Abrams, MD, a pediatrics professor at the University of Texas at Austin who reviewed the findings.

FDA officials tested more than 300 samples of commercial infant formula between 2023 and 2025 for heavy metals, including lead, arsenic, cadmium, and mercury. They also tested for pesticides, chemicals found in plastics known as phthalates, and PFAS, also known as per- and polyfluoroalkyl substances, sometimes called “forever chemicals.”

Levels of all the contaminants were undetectable or very low, the agency reported. The heavy metals detected were well below U.S. Environmental Protection Agency limits for drinking water. No pesticides were detected in 99% of samples. The FDA found no detections for 25 of the 30 PFAS compounds tested.

Outside experts generally agreed with the government’s assessment, noting that small amounts of substances such as heavy metals are naturally occurring in the environment. But others, such as phthalates and PFAS, are not.

“These chemicals are completely synthetic,” said Sheela Sathyanarayana, MD, MPH, a pediatrics professor at UW Medicine and the Seattle Children’s Research Institute. “The detection of some of these compounds at all is concerning.”

It points to the need for further monitoring of formula — and of the larger U.S. food supply, she added.

The Trump administration launched Operation Stork Speed in March 2025, promising to review safety and quality standards for infant formula in the U.S. for the first time in decades.

It built on previous FDA efforts to review substances like heavy metals in infant foods, which can cause problems with brain development, learning, and behavior in children, Abrams said.

To date, the FDA does not have enforceable limits for heavy metals in infant formulas, unlike the European Union, Canada, and Australia.

Some consumer advocacy groups have called on the FDA for years to establish firm limits for contaminants. Last year, Consumer Reports published an analysis of 41 U.S. infant formulas with results suggesting that many had worrisome levels of heavy metals and other contaminants.

However, that analysis used its own level of concern, setting it far below European Union standards. That report garnered wide public attention and prompted some parents to stop using commercial formula, even when it was necessary, Abrams noted.

Abrams called for the FDA to continue monitoring infant formula for contaminants and to share the results.

Abbott, one of the nation’s largest formula makers, urged the FDA to set scientific standards for contaminants in infant formula.

“We believe that producing infant formula at scale in the U.S. is a matter of national security,” Abbott spokesman John Koval said in an email. “These results affirm the safety of our current domestic supply.”