The U.S. Food and Drug Administration is proposing changes to the nutritional requirements of infant formula 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 the first of three proposed plans Thursday. The proposed rule would update the requirements for iodine, manganese, vitamin A, and vitamin D, and restate the existing requirements for chloride, potassium, selenium, and sodium.
The agency said it will also change the units of measurement for two nutrients and ask for public feedback on possible requirements for ingredients that are not currently required in infant formula but are sometimes added by manufacturers. These ingredients include arachidonic acid (ARA), docosahexaenoic acid (DHA) and L-carnitine, which the agency points to evidence showing they contribute to neurodevelopmental health in infants.
Subsequent phases will examine additional required nutrients, potential new needs and carbohydrate sources, the agency said. FDA plans to consolidate all changes into one final rule.
Parents, health care professionals and researchers are invited to submit public comments. The deadline is February 26th.
As part of the announcement, the FDA also released test results for new chemical contaminants in infant formula products sold in the United States. The agency tests formulas for pesticides, PFAS, phthalates and heavy metals such as arsenic, cadmium, lead and mercury. The company said most of the samples tested had “low or undetectable” levels of chemical contaminants, calling the findings “reassuring.”
The public can view the results on a newly launched dashboard. The agency said it will continue to monitor and test contaminant levels in formula and take action when appropriate.
“Parents should have confidence in every bottle they feed their infants,” U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. said in a press release. “In line with President Trump’s Operation Stork Speed and Make America Healthy Again agenda, we are proposing stricter nutritional requirements, testing formula for contaminants, and putting the results directly into the hands of parents. We will require infant formula manufacturers to adhere to rigorous scientific standards and put the health of babies first.”