For the first time since 1998, the U.S. Food and Drug Administration (FDA) has initiated a comprehensive review of infant formulas under the federal initiative “Operation Stork Speed,” led by Health Secretary Robert F. Kennedy Jr. This move aims to update the nutritional and safety standards of a product essential to millions of American infants.

Currently, around 75% of babies in the U.S. consume formula in their first six months of life, with about 40% relying exclusively on it . Formulas are required to meet specific guidelines: 30 essential nutrients with set minimums and maximums, and a caloric profile that mimics breast milk .

However, recent scientific advances have revealed the presence of contaminants such as arsenic, lead, and PFAS in several commercial formulas. A 2025 Consumer Reports study found concerning levels of these substances in about half of the 41 products analyzed . In response, the FDA is expanding its testing for heavy metals and other harmful agents .

The FDA also issued a public Request for Information (RFI) to gather scientific data and expert opinions on adjusting nutrient levels, introducing new beneficial ingredients, and improving labeling. A public expert panel is expected to meet in June 2025 to assess the input received.

While current formulas remain safe and nutritious, experts like Dr. Steven Abrams of the University of Texas argue this review is essential to align regulations with the latest science.

The review, expected to last at least a year, marks a significant effort to ensure infant formulas in the U.S. are safe, nutritionally adequate, and based on the most current scientific evidence.