FDA Proposes First Infant Formula Nutrient Overhaul in 27 Years
The agency is updating standards for iodine and vitamin D while releasing new data on chemical contaminants in baby formula.
By Rebecca Foster ·
The Food and Drug Administration is proposing the first major update to infant formula nutrient requirements in nearly three decades. The Department of Health and Human Services announced the move on Thursday, marking the initial step in a three-phase review of the ingredients allowed in baby formula. This proposal specifically addresses the levels of iodine, manganese, vitamin A, and vitamin D.
The agency also plans to standardize the units of measurement for two nutrients. It is seeking public input on whether to require arachidonic acid, docosahexaenoic acid, and L-carnitine, ingredients that are currently optional but often added by manufacturers. The FDA noted that evidence suggests these components support neurodevelopmental health in infants. Existing requirements for chloride, potassium, selenium, and sodium will remain in place under the new rule.
Subsequent phases of the review will examine other required nutrients, potential new ingredients, and carbohydrate sources. The FDA intends to consolidate all changes into a single final rule. The public comment period for this initial proposal closes on Feb. 26, allowing parents, healthcare professionals, and researchers to submit feedback.
Alongside the nutrient proposal, the agency released new testing results for chemical contaminants in infant formula products sold in the United States. The FDA tests samples for pesticides, PFAS, phthalates, and heavy metals including arsenic, cadmium, lead, and mercury. The agency reported that most samples contained low or non-detectable levels of these contaminants, describing the findings as reassuring.
The results are accessible to the public through a newly launched online dashboard. The FDA stated it will continue to monitor contaminant levels in formulas and take action when appropriate. HHS Secretary Robert F. Kennedy, Jr., emphasized the goal of ensuring product quality in a news release.
“Parents deserve confidence in every bottle they feed their baby,” Kennedy said. “Under President Trump’s Operation Stork Speed and Make America Healthy Again agenda, we are proposing stronger nutrient requirements, testing formula for contaminants, and putting the results directly in parents’ hands.”
The agency added that it will hold infant formula manufacturers to rigorous scientific standards and prioritize babies’ health. The next steps in the proposal process will involve reviewing additional nutrient categories as the agency moves toward finalizing the rules.
