The US Food and Drug Administration has proposed new nutrient limits for infant formula, opening the first comprehensive review of the rules since 1998. The agency published the proposed rule on 29 October 2026 as the first of three planned proposals under Operation Stork Speed, the federal review of infant formula nutrition announced in March 2025. If the rule is finalised, it would change requirements for four nutrients and reaffirm the requirements for four others, while later phases take up the rest of the 30 nutrients now required in infant formula sold in the United States.
Officials said the proposal is not driven by safety concerns, and formulas now on sale remain safe for babies. The Department of Health and Human Services said most samples in new chemical contaminant testing had low or non-detectable levels, and the agency launched a testing webpage and contaminants dashboard.
What the infant formula proposal changes
Four nutrients would see revised limits, all expressed per 100 kilocalories. Iodine, which supports thyroid hormone production and brain development, would move from a range of 5 to 75 micrograms to a range of 15 to 50 micrograms. That triples the minimum while lowering the maximum. Manganese, a trace mineral that supports enzyme function and bone development, would move from a minimum of 5 micrograms with no maximum to a range of 1 to 50 micrograms, giving it a first upper limit.
Vitamin A, which supports vision, immune function and cell growth, would move from 75 to 225 micrograms of retinol activity equivalents, equal to 250 to 750 international units, to 70 to 120 micrograms of retinol activity equivalents per 100 kilocalories. Only preformed vitamin A would count toward the limit, not beta-carotene. Vitamin D, which helps bones and teeth develop and helps prevent rickets, would move from 1 to 2.5 micrograms, equal to 40 to 100 international units, to 2 to 3 micrograms, equal to 80 to 120 international units. Vitamin A and vitamin D would also move from international units to metric units, and labelling rules would be updated to match.
Four other specifications would stay as they are: sodium at 20 to 60 milligrams, potassium at 80 to 200 milligrams, chloride at 55 to 150 milligrams, and selenium at 2 to 7 micrograms per 100 kilocalories. The proposal neither adds nor removes any required nutrient, but it asks for input on arachidonic acid, docosahexaenoic acid and L-carnitine, ingredients not now required but commonly added by makers.
Why infant formula rules are being reviewed now
Federal regulations require infant formula to contain 30 nutrients, each with a minimum level and 10 with a maximum. The Federal Food, Drug, and Cosmetic Act directs the agency to review those requirements every four years as appropriate, but its last comprehensive review was in 1998. For this phase, the FDA examined nutrient reference values, human milk composition, international standards, clinical literature since 1998, and comments from a 2025 request for information. The full review will undergo independent peer review.
Health Secretary Robert F. Kennedy Jr. announced the proposal in Des Moines, Iowa. Acting FDA Commissioner Kyle Diamantas said: “Under President Trump’s leadership, we are modernizing our nutritional requirements for infant formula for the first time in nearly three decades.” The agency invited comments from clinicians, parents, caregivers, scientists and industry. The comment period runs for 120 days, and the Department of Health and Human Services gave 26 February 2027 as the deadline for comments, under docket number FDA-2026-56789.
Dr. Steven Abrams, a pediatrician and professor at the University of Texas Dell Medical School who specialises in infant nutrition, told the Associated Press that parents are not likely to see changes on infant formula containers soon, and that the changes could take several years to reach shelves. The agency intends to fold all three phases into a single final rule, effective 60 days after publication, with a proposed compliance date three years after that for makers to reformulate and relabel.
What comes next for infant formula makers
A second phase, now under way, covers vitamin E, the B vitamins, folic acid, biotin, vitamin C, choline and inositol. A third phase, carried out by an outside organisation under FDA oversight, covers protein, fat, linoleic acid, iron, copper, zinc, calcium, phosphorus, magnesium and vitamin K, plus possible requirements for docosahexaenoic acid, arachidonic acid, alpha-linolenic acid and L-carnitine. Each phase should produce its own proposed rule.
For now, little changes for families or clinicians. The agency said infant formula on shelves need not change for years, with no immediate effect on the WIC program, and it will coordinate with the US Department of Agriculture and monitor supply during any transition. Final values could still shift after comment and peer review.