FDA affirms safety of infant formula from heavy metals

The U.S. infant formula supply is largely safe from contaminants, according to new testing results announced Wednesday by the Food and Drug Administration (FDA). 

Between 2023 and 2025, FDA purchased and tested more than 300 infant formula samples at retail stores covering 16 brands.  

The agency tested for contaminants such as heavy metals, pesticides and the “forever chemicals” known as per- and polyfluoroalkyl substances, or PFAS. 

Across all the products tested, the majority of infant formula samples had undetectable or very low levels of contaminants, the agency said. The levels of lead, mercury, cadmium and arsenic were below federal requirements for drinking water across all samples.  

There are currently no formal limits for contaminants in infant formula. 

“This testing — the first of its kind — reinforces that infant formula in the US is a safe option for parents and caregivers who rely on it,” FDA food chief Kyle Diamantas said in a statement. “We will continue working to drive contaminants to as low as possible through rigorous oversight.” 

The testing program is part of the agency’s Operation Stork Speed, a broader initiative aimed at examining the quality and improving the supply of infant formula in the U.S. In addition to testing, the agency is also conducting a review of nutritional standards.  

However, the initial round of testing did not check for botulism or other types of bacterial contamination that lead to major recalls and a nationwide shortage.  

For instance, ByHeart recalled all of its infant formula in November after babies who drank it were hospitalized with botulism. 

FDA said it initiated sampling for spore-forming microbiological contaminants on certain dairy-based ingredients in February.  

In 2022, manufacturer Abbott shut down a factory in Michigan after infant deaths triggered a recall in powdered formula. Inspectors found Cronobacter contamination and unsantiary conditions at the factory.  

Health Secretary Robert F. Kennedy Jr. will host chief executives from leading infant formula companies in May for a roundtable discussion focused on modernizing FDA’s infant formula oversight and continued implementation of Operation Stork Speed.