FDA clears second round of formula tests

Parents buying infant formula this week received confirmation that the latest federal testing found the product safe. The Food and Drug Administration released results from its second round of contaminant checks on Thursday. Acting FDA Commissioner Kyle Diamantas described the findings as reassuring during a news conference.

The agency initiated this testing after several product recalls and botulism cases linked to infant formula. Diamantas stated that most samples showed low or non-detectable levels of chemical contaminants. This result aligns with data from the first round of testing released in April, which also deemed the U.S. supply safe.

The FDA is now expanding its review beyond contaminants to include nutrient requirements. This marks the first comprehensive update to infant formula standards since 1998. The proposed changes will be released in three phases. If finalized, the new rules would adjust limits for iodine, vitamin A, vitamin D, and manganese. Existing requirements for chloride, potassium, selenium, and sodium would remain unchanged.

Regulators also plan to seek public input on ingredients that manufacturers currently add voluntarily. These include arachidonic acid and docosahexaenoic acid, two types of fatty acids, as well as L-carnitine, an amino acid. Diamantas noted that scientific evidence suggests these nutrients support neurodevelopment and health in infancy. The agency wants feedback from clinicians, industry experts, and the public before deciding whether to make these ingredients mandatory.

The FDA has launched a website and dashboard to allow the public to track testing results. The agency will complete a review of all 30 required ingredients in infant formula. Diamantas said these findings will be consolidated into a final, comprehensive rule.