FDA plans to update nutritional requirements for infant formula for the first time in nearly 30 years
The U.S. Food and Drug Administration is proposing changes to the nutritional requirements of infant formula. The update marks the first nutritional review of an infant formula in nearly 30 years, the agency’s acting director, Kyle Diamantas, said Thursday.
This review is part of the Trump administration’s Operation Stork Speed initiative, announced in March 2025.
The first phase of the review makes changes to four of the 30 nutrients required in the formula: iodine, manganese, vitamin A and vitamin D.
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Iodine is important for thyroid hormone production 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.
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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 establishes a new limit of 50 micrograms.
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Vitamin A supports vision, immune function and cell growth. The proposal decreases the amount of vitamin A required in infant formula from 250 international units per 100 calories to 233 IU. It would also change the units of measurement for vitamin A from IU to retinol activity equivalents, or RAE.
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Vitamin D contributes to the 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 allowable amount to 3 micrograms.
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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 is overdue. He praised the first phase as “really well done” and “very well thought out”.
The problem, Abrams said, is that the revision addresses the nutrient list in a piecemeal manner. This first group of nutrients will be followed by 12 over the next year and another batch of 10 after that. That means parents probably won’t see a change in infant formula anytime soon, he said.
“These changes that they’re recommending today won’t appear on formula boxes for several years,” said Abrams, an expert in infant nutrition.
The nutritional review was conducted by FDA scientists and will be subject to peer review, as required by law.
“Parents deserve to have confidence in every bottle they give their baby,” U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said in a press release.
“As part of Operation Stork Speed and President Trump’s Make America Healthy Again agenda, we are proposing stricter nutritional requirements, testing formula for contaminants, and putting the results directly in the hands of parents. We will hold infant formula manufacturers to rigorous scientific standards and prioritize the health of babies.”
The most consequential change in this first set of recommendations is the proposal to increase vitamin D, Abrams said.
Currently, the amount of vitamin D in infant formula is slightly lower than the recommended amount for babies. Many parents supplement formula with a vitamin D supplement.
Adding more vitamin D to infant formula could potentially save nearly $81 million each year in medical costs related to a diagnosis of late-onset hypocalcemia, or hypocalcemia, according to the proposed rule. Vitamin D helps the body absorb calcium and phosphorus from food.
The FDA reviewed several lines of evidence supporting the planned nutritional changes, including dietary reference values, or what the minimum amount would be to support healthy growth and development, as well as what would be considered toxic to an infant. She also looked at the nutritional composition of breast milk, nutritional standards used by other countries and new studies published since 1998.
Diamantas said the agency is seeking public input on nutrients that currently should not 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 is evidence that these nutrients contribute to infant neurodevelopment and health. And we want to hear from the scientific community, clinicians, industry and the public as we consider whether or not to make these nutrients mandatory in the infant formula supply in the United States,” Diamantas said.
The FDA said its review of nutrients for infant formula is ongoing. Later phases of this review will evaluate any remaining necessary nutrients, potential new nutrient requirements and carbohydrate sources, Diamantas said.
THURSDAY, health officials also provided an update on ongoing testing to detect chemical contaminants in infant formula; the latest results “continue to be reassuring,” Diamantas said.
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