FDA proposes rule updating nutrient requirements for infant formula
The Food and Drug Administration (FDA) announced on Thursday it is proposing a new rule that will update the nutrient requirements for infant formula.
The Department of Health and Human Services (HHS), which oversees the FDA, said in a press release that it would be the first major update to infant formula standards in nearly 30 years.
The proposed rule would update requirements for vitamin A, vitamin D, iodine and manganese as well as reaffirm existing requirements for chloride, potassium, selenium and sodium, the agencies said.
It would also change the units of measure for two nutrients and request public input on possible requirements for ingredients not currently required in infant formula but sometimes added by manufacturers, they noted.
The ingredients not currently required include arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine. Some studies have suggested they contribute greatly to infant growth, brain development and health.
The agency said there will be additional phases looking at the remaining required nutrients, potential new nutrient requirements and carbohydrate sources.
The FDA said it will welcome public comment during its phases and, in the future, will issue one final rule to cover all the proposed changes.
The FDA also released new data on chemical contaminant testing for infant formula and found that most samples tested had "low or non-detectable levels of chemical contaminants."
"Parents deserve confidence in every bottle they feed their baby," HHS Secretary Robert F. Kennedy, Jr. said in a statement, in part. "We will hold infant formula manufacturers to rigorous scientific standards and put babies' health first."
Last year, the HHS and FDA announced they would review the nutrition quality of infant formula in the U.S.
The FDA said the review -- part of its "Operation Stork Speed" initiative -- would look at whether current nutrient requirements need to be updated, including whether additional nutrients need to be considered.
Under current law, the HHS secretary reviews the table of required nutrients every four years as appropriate.
The FDA currently specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients, according to the agency.
Among the nutrients currently required are protein and fat, as well as vitamins A, D, E, K, folic acid, iron, magnesium and zinc.
Last year, then-FDA commissioner Dr. Marty Makary discussed removing seed oils from infant formulas. Many commercial baby formulas contain seed or vegetable oils due to the essential fatty acids they provide.
"Generally, they're believed to be pro-inflammatory," Makary said of seed oils during an interview on "Fox & Friends" in June 2025. "We don't want babies with general body inflammation. Forty percent of our nation's kids have a chronic condition. Many of those are tied to inflammation and insulin resistance."
Doctors have previously told ABC News that seed oils are not pro-inflammatory and can help lower glucose levels, improve insulin sensitivity, reduce bad (LDL) cholesterol, reduce triglycerides and increase levels of positive (HDL) cholesterol.
ABC News' Katie Kindelan contributed to this report.
