FDA Proposes First Infant Formula Nutrient Updates in 30 Years

The Food and Drug Administration announced on Thursday that it is proposing updates to the nutrient standards for infant formula sold in the United States. This marks the first time in nearly three decades that the agency has reviewed the specific ingredients and requirements for these products. The Department of Health and Human Services, which oversees the FDA, released the first of three planned proposals.

The proposed rule would revise the requirements for iodine, manganese, vitamin A, and vitamin D. It also reaffirms the existing standards for chloride, potassium, selenium, and sodium. In addition to changing nutrient levels, the FDA is proposing new units of measure for two specific nutrients.

The agency is also asking for public feedback on ingredients that are not currently required but are often added by manufacturers. These include arachidonic acid, docosahexaenoic acid, and L-carnitine. The FDA states that evidence suggests these components contribute to neurodevelopmental health in infants.

Future phases of the review will examine additional required nutrients, potential new mandates, and carbohydrate sources. The FDA intends to consolidate all changes into a single final rule. Parents, healthcare professionals, and researchers can submit public comments by February 26.

Alongside the nutrient proposals, the FDA released new chemical contaminant testing results for infant formula products available in the U.S. market. The agency tests formula for pesticides, PFAS, phthalates, and heavy metals including arsenic, cadmium, lead, and mercury. Officials reported that most samples showed low or non-detectable levels of these contaminants, describing the findings as reassuring.

The results are now available on a newly launched public dashboard. The agency said it will continue to monitor and test contaminant levels in formulas and will take action when appropriate. HHS Secretary Robert F. Kennedy, Jr., stated in a news release that parents deserve confidence in every bottle they feed their baby.

Kennedy said the administration is proposing stronger nutrient requirements and testing formula for contaminants under the Operation Stork Speed and Make America Healthy Again agenda. He emphasized that the agency will hold manufacturers to rigorous scientific standards to prioritize infant health.