The Food and Drug Administration released new testing data Wednesday indicating that the U.S. infant formula supply remains largely free of harmful contaminants, including heavy metals and so-called forever chemicals. The findings come from a two-year sampling effort under the agency's Operation Stork Speed initiative.
Between 2023 and 2025, FDA officials purchased and analyzed more than 300 infant formula products from retail stores, covering 16 different brands. The tests screened for heavy metals such as lead, mercury, cadmium, and arsenic, as well as pesticides and per- and polyfluoroalkyl substances (PFAS).
According to the agency, the vast majority of samples showed either undetectable or very low levels of these contaminants. In all cases, the concentrations of heavy metals fell below the federal limits set for drinking water. However, the FDA acknowledged that there are currently no formal contaminant limits specifically for 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,” said Kyle Diamantas, the FDA’s food chief, in a statement. “We will continue working to drive contaminants to as low as possible through rigorous oversight.”
The testing program is part of Operation Stork Speed, a broader FDA effort to assess quality and strengthen the infant formula supply chain. In addition to contaminant testing, the agency is also reviewing nutritional standards for formula products. The initiative comes amid ongoing scrutiny of the industry following high-profile recalls and shortages.
Notably, the initial round of testing did not examine bacterial contamination such as botulism or Cronobacter, which have triggered major recalls in recent years. For instance, in November, ByHeart recalled all of its infant formula after several infants were hospitalized with botulism. The FDA said it began sampling for spore-forming microbiological contaminants in dairy-based ingredients in February.
The 2022 shutdown of an Abbott manufacturing plant in Michigan, linked to infant deaths and Cronobacter contamination, remains a pivotal moment for the industry. Inspectors found unsanitary conditions at the facility, leading to a nationwide powdered formula shortage that exposed vulnerabilities in the supply chain. State attorneys general have since pushed for stronger oversight on child safety issues, though federal action has been uneven.
Health Secretary Robert F. Kennedy Jr. is scheduled to host a roundtable in May with chief executives of major infant formula companies. The discussion will focus on modernizing FDA oversight and advancing Operation Stork Speed. Meanwhile, some lawmakers have signaled openness to new safety measures in light of ongoing supply chain risks.
The FDA’s findings offer some reassurance to parents, but critics note the absence of formal contaminant limits and the limited scope of testing. The agency has pledged to continue monitoring and to push contaminant levels as low as possible through its oversight programs.
