- On April 29, 2026, the U.S. Food and Drug Administration (FDA) announced the results of the largest and most comprehensive testing program ever conducted on infant formula sold in the United States. As part of Operation Stork Speed and the agency’s broader Closer to Zero initiative, FDA analyzed more than 300 retail products, generating over 120,000 data points across a wide range of potential chemical contaminants. The testing covered powdered, ready-to-feed, and concentrated liquid formulas and included analysis for heavy metals, pesticides, PFAS, phthalates, and other substances that may be present due to environmental or agricultural factors.
- Overall, FDA’s findings reinforced that all infant formula products on the U.S. market meet a high safety standard, with most samples showing undetectable or very low levels of the contaminants tested. Agency leadership emphasized that these results are encouraging and affirm the general safety of the U.S. infant formula supply.
- Specifically, all samples tested contained levels of lead, mercury, cadmium, and arsenic that were significantly below U.S. Environmental Protection Agency drinking water standards when prepared for feeding. Pesticides were not detected in 99 percent of samples tested, and none of the 25 out of 30 tested most commonly assessed PFAS compounds were detected in any sample. Among the remaining PFAS analytes, 95 percent of products had total PFAS levels at or below 28 parts per trillion, while 95 percent of samples showed phthalate concentrations at or below 116 parts per billion.
- FDA plans to continue targeted and routine surveillance, expand testing to additional contaminants, and work with manufacturers to push contaminant levels as low as reasonably achievable. The agency also indicated it will continue developing formal action levels where appropriate.
- Keller and Heckman will continue to monitor regulatory and policy developments affecting infant formula safety and supply.