FDA: Most infant formula meets high safety standards in largest-ever U.S. testing

GCM Staff Report
Posted 5/8/26

The U.S. Food and Drug Administration on April 29 released results from what it called the largest and most rigorous examination of chemical contaminants in infant formula sold in the United States, …

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FDA: Most infant formula meets high safety standards in largest-ever U.S. testing

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The U.S. Food and Drug Administration on April 29 released results from what it called the largest and most rigorous examination of chemical contaminants in infant formula sold in the United States, finding that most products meet high safety standards while pledging continued oversight and additional testing.

The agency analyzed more than 300 samples representing formulas sold at retail nationwide, generating more than 120,000 data points, a news release said. Products tested included powders, ready-to-feed liquids and concentrated liquids. FDA laboratories screened for lead, mercury, cadmium, arsenic, pesticides including glyphosate and glufosinate, per- and polyfluoroalkyl substances, known as PFAS, and phthalates.

Across the samples, an overwhelming majority showed undetectable or very low levels of contaminants, the agency said, affirming the safety of the U.S. infant formula supply. The findings come as millions of families rely on formula as a primary or supplemental source of nutrition, even as breast milk remains widely considered the optimal choice when available.

“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,” Health and Human Services Secretary Robert F. Kennedy Jr. said in the release. “We will hold manufacturers accountable, and give parents honest, transparent data they can trust. Protecting our children’s health is nonnegotiable.”

FDA Commissioner Marty Makary, M.D., M.P.H., said the results provide reassurance while underscoring the agency’s broader mission to safeguard vulnerable populations.

“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.”

Despite the generally low levels detected, the FDA said it will expand testing and take additional steps where needed. Those actions include evaluating more contaminants, working with manufacturers to reduce levels as much as possible and establishing formal action levels for substances found in infant formula.

Small amounts of contaminants can occur naturally or enter food through environmental exposure during growing or manufacturing processes, and may be present in both infant formula and breast milk, the agency noted.

The testing is part of Operation Stork Speed, the FDA’s Closer to Zero initiative and its routine food surveillance efforts aimed at ensuring safe and reliable nutrition for infants. The agency said it will continue sampling products that have entered the market since the survey began and conduct additional compliance testing, with results to be released publicly.

“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 Deputy Commissioner for Food Kyle Diamantas. “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.”

Kennedy is scheduled to host chief executives from leading infant formula companies in May for a roundtable discussion focused on modernizing FDA oversight and continuing implementation of Operation Stork Speed, including efforts related to nutrition, chemical safety and microbiological standards.