FDA Proposes Changes to Infant Formula Nutrient Requirements
The U.S. Food and Drug Administration is proposing the first updates to infant formula nutrient requirements in nearly 30 years. Read on for how the requirements will be tweaked to align with the updated health evidence.
First Phase of Formula Changes Surrounds Four Key Nutrients
The U.S. Food and Drug Administration (FDA) announced last week that it is proposing several changes to the nutrient requirements for infant formula. The agency's acting Commissioner for Human Foods, Kyle Diamantas, outlined the proposed changes.
The changes mark the first time in almost 30 years that the requirements have been updated. The changes are part of the broader Operation Stork Speed, an initiative announced by the Trump administration in March of 2025.
The review will be rolled out in phases. The first phase includes changes to four of the 30 required formula nutrients. The FDA is proposing that the amount of iodine be tripled from 5 micrograms to 15. The new upper limit for iodine is 50 micrograms. Iodine has been shown to be essential in brain development in growing infants, as well as for the production of thyroid hormones.
The proposal also reduces the minimum required amount of manganese from 5 micrograms to 1 microgram per 100 calories of formula, while also establishing a limit of 50 micrograms. This trace mineral supports bone development and enzyme function.
Under the new proposal, the amount of vitamin A in formula would be lowered from 250 international units (IU) to 233 IU per 100 calories. The rule would also change the units of measure from IU to retinol activity equivalents (RAE). Vitamin A is crucial for vision, cell growth, and immune system function.
The first phase will also double the minimum required amount of vitamin D from 1 to 2 micrograms while increasing the maximum amount allowed to 3 micrograms. Vitamin D supports bone and teeth development and prevents rickets.
Lastly, this phase reaffirms the recognized requirements for selenium, sodium, potassium, and chloride.
Dr. Steven Abrams, a pediatrician and professor at the University of Texas’ Dell Medical School, praised the update, saying that the first phase is “really well done” and “very well thought-out.” However, Abrams expressed concern about the piecemeal approach to the changes. The first phase of changes will be followed by a dozen more in the next year, with the last 10 not happening until after that.
Abrams warned that this means the changes will not be made for quite some time. The expert on infant nutrition explained that “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."
About the Review
As required by federal law, FDA scientists conducted the review and then submitted it for peer review. U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said that “parents deserve confidence in every bottle they feed their baby." He went on to say in the news release that “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.”
Abrams noted that the most meaningful change in the first phase is the proposal to boost vitamin D requirements. The current amount is slightly below the recommended level for infants. As such, many parents decide to supplement with additional vitamin D.
The FDA said that adding more vitamin D to formula could save almost $81 million annually in medical costs. Vitamin D is instrumental in helping the body absorb phosphorus and calcium. The boost in the nutrient could prevent low blood calcium, a condition known as late-onset hypocalcemia.
The agency looked at a variety of data supporting the planned changes. In addition to looking at minimum values, scientists also researched what levels would be toxic for an infant. The standards were compared to the natural composition of breast milk, new evidence since 1998, and what other countries have set for their requirements.
Diamantas said that the group is also asking for public input on nutrients that are not required but are often added by formula manufacturers. This includes long-chain fatty acids such as DHA and ARA.
“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.
Diamantas also confirmed that the review is ongoing, with subsequent phases designed to assess the remaining nutrients as well as the possibility of adding new requirements and carbohydrate sources.
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