The FDA is considering more changes, and this time it’s infant formula that will receive a revamp of requirements. The Department of Health and Human Services (HHS), which oversees the FDA, announced that it will update formula ingredients for the first time in 30 years. The proposed rule would update requirements for vitamin A, vitamin D, iodine, manganese, and reaffirm existing requirements for chloride, potassium, selenium, and sodium, the agencies said.
“Parents deserve confidence in every bottle they feed their baby,” HHS Secretary Robert F. Kennedy, Jr. said in a statement. “We will hold infant formula manufacturers to rigorous scientific standards and put babies’ health first.”
The ingredients not currently required include arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine. Some studies suggest they contribute significantly to infant growth, brain development, and health. The FDA is now using a chemical containment process to test the new formulas and other ingredients to remove unnecessary chemicals.
The FDA said the review part of its “Operation Stork Speed” initiative would assess whether current nutrient requirements need updating, including whether additional nutrients should be considered.
Currently, the FDA requires 30 specific nutrients in infant formulas. The new formulas will include at least all 30 nutrients and maximum amounts for 10 of them.
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 because they provide essential fatty acids.
“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.”
In the past month, the FDA has recalled several different items, including meat, cheese, frozen goods, and vegetables. There was also a recall of lettuce that resulted in hundreds of people experiencing explosive diarrhea.
The FDA as a whole has been under consistent scrutiny from the public because of its rule changes and lax enforcement of standards.
Much of the criticism has been directly focused on FDA Commissioner Marty Makary.
“The problem is that the commissioner is replacing standards of safety and efficacy with fear and favor,” Congressman Jake Auchincloss (D–MA) said to CNBC’s Becky Quick at the CNBC Cures Summit in New York City.
Auchincloss added that Makary’s actions are “undermining patient confidence in the therapies that come to market, and that is undermining the ability of innovators to bring medicines to market with confidence.”
