FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.

Agency to Continue Rigorous Oversight and Additional Testing

The U.S. Food and Drug Administration today announced results from the largest and most rigorous examination ever conducted focused on chemical contaminants in infant formula available on the U.S. market. While breast milk is widely considered the gold standard and optimal source of nutrition for infants whenever possible, millions of parents depend on formula.

“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 Health and Human Services Secretary 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.”

“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,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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.”

Across the products tested, an overwhelming majority of samples had undetectable or very low levels of contaminants, affirming that the U.S. infant formula supply is safe. The FDA tested more than 300 infant formula samples representative of products sold at retail across the U.S.—generating more than 120,000 data points—for lead, mercury, cadmium, arsenic, pesticides (including glyphosate and glufosinate), per- and polyfluoroalkyl substances (PFAS), and phthalates. The samples, which included powders, ready-to-feed liquids, and concentrated liquids, were rigorously tested and analyzed in FDA laboratories.

While overall levels of contaminants in the infant formula samples tested were low, the FDA is following up with additional testing as part of the agency’s ongoing robust monitoring and oversight efforts and will take additional action where appropriate. This includes conducting further testing, including for additional contaminants, continuing to engage with manufacturers on measures to reduce the levels of contaminants to as low as possible, and working to establish action levels for contaminants in infant formula.

“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, J.D., Deputy Commissioner for 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.”

Small amounts of contaminants may be present in foods—including infant formula and breast milk—because they occur naturally or enter the environment through human activities in the areas where ingredients are grown or produced.  

This testing was conducted as part of Operation Stork Speed, the FDA’s Closer to Zero initiative, and the FDA’s routine food surveillance work to help ensure safe, reliable, and nutritious infant formula for families across the U.S.

The FDA will continue to test infant formula as part of Operation Stork Speed and ongoing surveillance of foods, including testing infant formula products that have entered the U.S. market since this initial survey began and conducting additional compliance sampling. Consistent with FDA’s commitment to transparency, the agency will share results from follow-up surveys.

Secretary Kennedy 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, which includes aspects of nutrition, chemical, and microbiological food safety.