WHAT YOU NEED TO KNOW
  • The FDA is proposing its first review of infant formula nutrient requirements in nearly 30 years.
  • The first phase addresses iodine, manganese, vitamin A and vitamin D, with additional nutrient reviews planned.
  • The proposed vitamin D increase could potentially save nearly $81 million annually in medical costs associated with late-onset hypocalcemia.
  • The FDA is also requesting public input on commonly added nutrients including ARA, DHA and L-carnitine.

The US Food and Drug Administration is proposing changes to nutrient requirements for infant formula, beginning the agency’s first nutrition review of formula in nearly 30 years. Acting director Kyle Diamantas announced the update Thursday.

The review is part of Operation Stork Speed, an initiative announced by the Trump administration in March 2025. Its first phase addresses four of the 30 nutrients currently required in infant formula: iodine, manganese, vitamin A and vitamin D.

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

Abrams raised concerns, however, about the decision to review the required nutrients in separate groups. The current set is expected to be followed by 12 nutrients in the next year or so, with another group of 10 coming afterward.

That timeline means parents probably will not see changes to infant formula soon, Abrams 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, an infant nutrition expert.

FDA staff scientists conducted the nutrition review, which will be submitted for peer review as required by law. The agency said its broader examination of nutrients in infant formula remains underway.

“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.”

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Abrams said the proposal to increase vitamin D is the most consequential recommendation in the first group. The proposed rule said adding more vitamin D to formula could potentially save nearly $81 million annually in medical costs associated with diagnoses of late-onset hypocalcemia, or low blood calcium.

Vitamin D helps the body absorb calcium and phosphorus from food. It also supports the development of bones and teeth and helps prevent rickets, a condition involving soft bones.

The proposal would double the minimum required amount of vitamin D from 1 microgram to 2 micrograms. It would also increase the maximum permitted amount to 3 micrograms.

Iodine supports thyroid hormone production and brain development in infants. The proposed rule would triple the required amount from 5 micrograms to 15 micrograms and establish a new upper limit of 50 micrograms.

Manganese is a trace mineral that assists enzyme function and bone development. The proposal would lower the minimum required amount from 5 micrograms to 1 microgram per 100 calories while establishing a new maximum of 50 micrograms.

Vitamin A supports vision, immune function and cell growth. The FDA proposal would reduce the required amount from 250 international units per 100 calories to 233 IU and change its measurement from IU to retinol activity equivalents, or RAE.

The proposed rule also reaffirms existing requirements for chloride, potassium, selenium and sodium. In developing its recommendations, the FDA reviewed evidence including nutrient reference values, potential toxicity for infants, the nutrient composition of human milk and standards used by other countries.

The agency also considered new studies published since 1998. Its evaluation examined both minimum amounts needed to support growth and development and levels that could be toxic to an infant.

The FDA is seeking public input on nutrients that manufacturers commonly add even though they are not currently required. Those include long-chain fatty acids such as ARA and DHA, along with 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.

Future phases will examine every remaining required nutrient, possible new nutrient requirements and carbohydrate sources, Diamantas said. Health officials also provided an update Thursday on continuing tests for chemical contaminants in infant formula.

The newest batch of testing results “continue to be reassuring,” Diamantas said. The nutrient proposals and contaminant testing are both proceeding as the FDA continues its wider infant formula review.