Food and Drug Administration releases largest infant formula safety study results

The U.S. Food and Drug Administration (FDA) has released findings from its largest examination to date of chemical contaminants in infant formula sold in the United States, reporting that most products meet established safety standards with low or undetectable contaminant levels.

The agency tested more than 300 infant formula samples, generating over 120,000 data points across a range of substances, including lead, mercury, cadmium, arsenic, pesticides, per- and polyfluoroalkyl substances, and phthalates. Products evaluated included powdered, ready-to-feed, and concentrated liquid formulas available at retail.

According to the agency, the results confirm that the U.S. infant formula supply is generally safe. However, regulators emphasized that even low-level exposure remains a concern for infants, prompting continued monitoring and follow-up actions.

Health and Human Services Secretary Robert F. Kennedy Jr. said the findings show most products meet high safety standards while underscoring the need for accountability and transparency in reporting contaminant levels.

FDA Commissioner Marty Makary described the results as encouraging and said the agency will continue efforts to strengthen both safety and supply chain resilience for infant formula.

The agency said it will expand testing as part of ongoing surveillance efforts, including evaluating additional contaminants, conducting compliance sampling, and working with manufacturers to reduce contaminant levels as much as possible. The FDA also plans to establish action levels for certain substances in infant formula.

The testing was conducted under Operation Stork Speed and the Closer to Zero initiative, which aim to reduce exposure to contaminants in foods consumed by infants and young children.

Officials noted that trace contaminants can occur naturally in the environment or enter food during agricultural production, making complete elimination difficult. As a result, regulatory efforts are focused on minimizing exposure through oversight and industry collaboration.

The FDA said it will continue to publish findings from future testing and engage industry leaders in discussions on modernizing oversight and advancing infant formula safety.