FDA plans to update infant formula nutrition requirements for first time in nearly 30 years

By Brenda Goodman, CNN

(CNN) — The US Food and Drug Administration is proposing changes to nutrient requirements for infant formula. The update marks the first nutrition review for formula in nearly 30 years, the agency’s acting director, Kyle Diamantas, said Thursday.

The review is part of the Trump administration’s Operation Stork Speed initiative, which was announced in March 2025.

The first phase of the review makes changes to four of the 30 required nutrients in formula: iodine, manganese, vitamin A and vitamin D.

• Iodine is important for the production of thyroid hormone and brain development in infants. The proposed rule triples the amount of iodine required in infant formula, from 5 micrograms to 15, and sets a new upper limit of 50 micrograms.
• Manganese is a trace mineral that supports enzyme function and bone development. The proposal reduces the minimum required amount from 5 micrograms to 1 microgram per 100 calories, and it establishes a new limit of 50 micrograms.
• Vitamin A supports vision, immune function and cell growth. The proposal decreases the amount of vitamin A required in formula, from 250 international units per 100 calories to 233 IU. It would also change the units of measure for vitamin A from IU to retinol activity equivalents, or RAE.
• Vitamin D helps with development of bones and teeth and helps prevent rickets, or soft bones. The proposed rule doubles the minimum required amount of vitamin D from 1 to 2 micrograms and increases the maximum amount allowed to 3 micrograms.
• The proposed rule also reaffirms requirements for chloride, potassium, selenium and sodium.

Dr. Steven Abrams, a pediatrician and professor at the University of Texas’ Dell Medical School, said the nutrition update was overdue. He praised the first phase as “really well done” and “very well thought-out.”

The problem, Abrams said, is that the review is tackling the nutrient list piecemeal. This first group of nutrients will be followed by 12 in the next year or so and another batch of 10 after that. That means parents aren’t likely to see any changes to infant formula anytime soon, he said.

“These changes that they’re recommending today are not going to be something that’ll show up on the can of formula potentially for several years,” said Abrams, who is an expert on infant nutrition.

The nutrition review was conducted by the FDA’s staff scientists and will be submitted for peer review, as required by law.

“Parents deserve confidence in every bottle they feed their baby,” US Health and Human Services Secretary Robert F. Kennedy Jr. said in a 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.”

The most consequential change in this first slate of recommendations is the proposal to increase vitamin D, Abrams said.

Right now, the amount of vitamin D in infant formula is a little below the recommended amount for babies. Many parents supplement formula with extra vitamin D.

Adding more vitamin D to formula could potentially save nearly $81 million each year in medical costs tied to a diagnosis of late-onset hypocalcemia, or low blood calcium, the proposed rule said. Vitamin D helps the body absorb calcium and phosphorus from food.

The FDA looked at several lines of evidence supporting the planned nutrition changes, including nutrient reference values, or what the minimum amount would be to support health growth and development, as well as what would be considered toxic for an infant. It also looked at the nutrient composition of human milk, nutrient standards used by other countries and new studies published since 1998.

Diamantas said the agency is seeking public input on nutrients that are not currently required to be added to infant formula but are commonly added by manufacturers, including long-chain fatty acids like ARA and DHA, as well as L-carnitine, which helps the body break down fats and use them in tissues.

“There’s evidence that these nutrients contribute to neurodevelopment and health in infancy. And we want to hear from the scientific community, from clinicians, from industry, and the public as we consider whether or not to make these nutrients mandatory in the U.S. infant formula supply,” Diamantas said.

The FDA said its nutrient review for infant formula is ongoing. Subsequent phases of this review will assess all of the remaining required nutrients, potential new nutrient requirements and carbohydrate sources, Diamantas said.

On Thursday, health officials also provided an update on ongoing testing for chemical contaminants in infant formula; the latest batch of results “continue to be reassuring,” Diamantas said.

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