The Food and Drug Administration has proposed a rule that would change how much iodine, manganese, vitamin A and vitamin D must be packed into every can of infant formula sold in the United States, marking what regulators are calling the first nutrition review for formula in nearly 30 years. Current formulas already on store shelves remain safe, and officials say the proposal was not driven by any safety concerns.
The update marks the first nutrition review for formula in nearly 30 years, according to CNN. The first phase of the review changes four of the 30 required nutrients in formula — iodine, manganese, vitamin A and vitamin D — per that same report. As ABC7 Chicago reports, the proposed rule also changes the units of measure for two nutrients while reaffirming current requirements for chloride, potassium, selenium and sodium.
What Changes, Nutrient by Nutrient
Under the proposal, the iodine range would shift to 15 to 50 micrograms per 100 kilocalories, down from the current range of 5 to 75 micrograms, according to Contemporary Pediatrics. The outlet reports that manganese's minimum would drop from 5 micrograms to 1 microgram per 100 kilocalories, with a new 50-microgram ceiling added where none existed before.
Vitamin A requirements would move to 70 to 120 micrograms of retinol activity equivalents per 100 kilocalories, and only preformed vitamin A would count toward those limits, per the same report. Vitamin D's range would rise to 2 to 3 micrograms — or 80 to 120 international units — per 100 kilocalories, up from the current 1 to 2.5 micrograms. The outlet notes that current specifications for sodium, potassium, chloride and selenium remain appropriate under the proposal.
A Dollar Figure Behind the Vitamin D Shift
The proposed rule states that increasing vitamin D could potentially save nearly $81 million each year in medical costs tied to a diagnosis of late-onset hypocalcemia, per CNN's report. The FDA has emphasized that formulas currently on the market remain safe for infants, and the agency has said the proposed changes were not driven by safety concerns, according to the same Contemporary Pediatrics account. The proposal neither adds nor removes any required nutrient, the outlet notes.
According to ABC7 Chicago, the FDA specifies 30 nutrients that must be included in infant formula, setting minimum amounts for all 30 and maximum amounts for 10 of them. Currently required nutrients include protein, fat, vitamins A, D, E and K, folic acid, iron, magnesium and zinc, the outlet reports. Mary Kekatos authored that account of the proposed rule.
Public Input Sought on ARA, DHA and L-Carnitine
The FDA is also seeking public input on whether arachidonic acid (ARA), docosahexaenoic acid (DHA) and L-carnitine — ingredients not currently required but commonly added by manufacturers — should become mandatory, according to CNN. ABC7 Chicago reports that some studies suggest these ingredients contribute to infant growth, brain development and overall health. However, a systematic review and meta-analysis found that results on DHA and ARA supplementation and infant cognitive function have been inconsistent, according to a study indexed on PubMed.
A second phase of the FDA's broader review, now underway, covers vitamin E and the B vitamins, Contemporary Pediatrics reports. CNN adds that this first group of nutrients will be followed by 12 more in the next year or so, with another batch of 10 addressed after that. Subsequent phases will assess all remaining required nutrients, potential new nutrient requirements and carbohydrate sources, per the same report. The FDA welcomes public comment during its phases and will issue one final rule covering all proposed changes, according to ABC7 Chicago.
Part of a Broader Federal Push
The review is part of the Trump administration's Operation Stork Speed initiative, announced in March 2025, CNN reports. HHS and the FDA launched the review to examine whether current nutrient requirements need updating and whether additional nutrients should be considered, per ABC7 Chicago's account. The Department of Health and Human Services has described the proposed update as the first major update to infant formula standards in nearly 30 years, and under the law the HHS secretary reviews the table of required nutrients every four years as appropriate.
Robert F. Kennedy Jr. said parents deserve confidence in every bottle they feed their baby, and that infant-formula manufacturers would be held to rigorous scientific standards with babies' health coming first, according to ABC7 Chicago. The FDA has also released new chemical contaminant testing data for infant formula, finding that most tested samples had low or non-detectable levels of contaminants, the outlet reports.
Separately, then-FDA Commissioner Marty Makary discussed removing seed oils from infant formulas in 2025, saying seed oils are generally believed to be pro-inflammatory and noting that 40 percent of the nation's children have a chronic condition, many tied to inflammation and insulin resistance, according to ABC7 Chicago. Commercial baby formulas contain seed or vegetable oils because of their essential fatty acids, the outlet notes, and doctors have previously told ABC News that seed oils are not pro-inflammatory and can help lower glucose, improve insulin sensitivity, reduce LDL cholesterol and triglycerides, and increase HDL cholesterol.
