FDA proposes new nutrient limits for infant formula, its first broad update since 1998

The proposal would raise the minimums for iodine and vitamin D and cap manganese for the first time, with public comments due March 2.

By Anjali Venkatram

The Food and Drug Administration on Monday formally proposed new minimum and maximum levels for four nutrients in infant formula. It is the first part of what the agency calls its first comprehensive review of formula nutrition since 1998, and the changes would reach every can sold in the United States, including formula provided through California’s WIC program, which serves roughly 177,000 infants in an average month.

The proposed rule, published in the Federal Register under docket FDA-2026-N-10832, reviews eight of the 30 nutrients federal law requires in formula. It would change the limits for iodine, vitamin A, vitamin D and manganese, and keep the current limits for chloride, selenium, potassium and sodium.

Health and Human Services Secretary Robert F. Kennedy Jr. announced the proposal on Oct. 29 at an event in Des Moines. He described it as part of Operation Stork Speed, the administration’s review of the formula supply, and its Make America Healthy Again agenda. “Parents deserve confidence in every bottle they feed their baby,” Mr. Kennedy said in an HHS release. The administration, he said, would “hold infant formula manufacturers to rigorous scientific standards and put babies’ health first.”

Kyle Diamantas, the acting FDA commissioner, said the agency was “modernizing our nutritional requirements for infant formula for the first time in nearly three decades.”

What would change

The proposal rests on the Federal Food, Drug, and Cosmetic Act and the Infant Formula Act of 1980. Congress passed that law after a chloride-deficient soy formula sickened roughly 150 infants in 1978 and 1979. A 2022 law passed after the national formula shortage requires the FDA to review the nutrient table “every 4 years as appropriate.”

The largest proposed change is to iodine. The minimum would triple, from 5 to 15 micrograms per 100 calories, and the maximum would fall from 75 to 50 micrograms.

For vitamin D, the minimum would double, to 2 micrograms (80 international units) per 100 calories, and the maximum would rise to 3 micrograms. The rule would also express vitamin D in micrograms rather than international units, a change that would require new labels on every formula product. Vitamin A would be measured as retinol activity equivalents, with a minimum of 70 micrograms and a maximum of 120. Only preformed vitamin A would count toward the minimum, so beta-carotene added to formula would no longer satisfy it.

Manganese would see the biggest change in approach. The FDA would lower the minimum from 5 to 1 microgram per 100 calories and set a ceiling of 50 micrograms, the first maximum ever set. The agency says manganese “becomes neurotoxic at elevated levels” and that infants are especially vulnerable. It notes that soy-based formulas carry roughly 200 to 300 micrograms per liter, up to 100 times the level in human milk. The FDA also acknowledges that the human studies it relied on can show associations but have limited ability to prove cause and effect.

Costs, benefits and timing

The FDA estimates annualized benefits of $80.9 million, using a 7 percent discount rate, within a range of $18.8 million to $171.7 million. Nearly all of that comes from fewer cases of late-onset hypocalcemia, a calcium disorder tied to vitamin D deficiency. The agency calls that figure a lower bound because it could not put a dollar value on other effects. It puts annualized costs at about $17.6 million, mainly for manufacturers to relabel and reformulate products and file required notices.

A final rule would take effect 60 days after publication. The FDA proposes giving manufacturers three years to comply, counted from the effective date of the final rule that completes its phased review, and its analysis assumes benefits begin in 2031. The agency says it plans an external peer review. Two more proposals are planned, including one covering protein, fat and iron, according to the FDA’s rulemaking page.

HHS also asked for public input on three ingredients outside the current review: the fatty acids DHA and ARA and the nutrient L-carnitine. Alongside the proposal, HHS released results of its testing of formula for heavy metals and other contaminants. The department said most samples showed low or non-detectable levels, and it posted the data on a public dashboard while it works toward action levels under its Closer to Zero program.

Comments on the proposal are due March 2, 2027, according to the Federal Register notice. Last week’s HHS release had given a Feb. 26 deadline and a different docket number. The Federal Register notice is the official version.

The California stake

California’s WIC program, run by the state Department of Public Health, served an average of 176,938 infants a month in the 2023-24 fiscal year, according to the department’s November budget estimate. Nearly half of all California infants born in 2018 were enrolled in their first year of life. Formula makes up about 22 percent of the program’s gross food spending, an expense the state offsets with an estimated $186.4 million in rebates this fiscal year from its contracted formula manufacturer.

The program’s numbers show how a federal formula change would spread. A reformulated product moves through state WIC contracts, hospital nurseries and grocery shelves in every county at once. The 2022 shortage, which left store shelves bare across the country, showed how much of the nation’s supply depends on a few manufacturers.

The Infant Nutrition Council of America, which represents formula makers, and the American Academy of Pediatrics did not respond to requests for comment.