FDA proposes changes to nutritional standards in infant formula

The Food and Drug Administration is proposing changes to infant formula nutrient requirements as part of the agency’s first review of its ingredients and standards in nearly three decades.

The Department of Health and Human Services, which oversees the FDA, announced Thursday the first of three planned proposals. The proposed rule would update requirements for iodine, manganese, vitamin A and vitamin D, and reaffirm existing requirements for chloride, potassium, selenium and sodium.

It would also change the units of measure for two nutrients and request public feedback on possible requirements for ingredients not currently required in infant formula but sometimes added by manufacturers, the agency said. Among those ingredients are arachidonic acid (ARA), docosahexaenoic acid (DHA) and L-carnitine, which the agency notes evidence suggests they contribute to neurodevelopmental health in infants.

Subsequent phases will examine additional required nutrients, potential new requirements and carbohydrate sources, the agency said. The FDA plans to consolidate all the changes into a single final rule.

Parents, healthcare professionals and researchers are invited to submit public comment. The deadline is Feb. 26.

As part of the announcement, the FDA also released new chemical contaminant testing results for infant formula products sold in the U.S.. The agency tests formula for pesticides, PFAS, phthalates and heavy metals such as arsenic, cadmium, lead and mercury. It said most of the samples tested had “low or non-detectable levels of chemical contaminants,” and called the findings “reassuring.”

The results are available to the public to view on a newly launched dashboard. The agency said it will continue to monitor and test contaminant levels in formulas, and take action when appropriate.

“Parents deserve confidence in every bottle they feed their baby,” HHS Secretary Robert F. Kennedy, Jr. said in news release. “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. We will hold infant formula manufacturers to rigorous scientific standards and put babies’ health first.”