WASHINGTON — The Food and Drug Administration has formally proposed the first broad rewrite of infant formula nutrition rules in nearly three decades, a step that would change the required amounts of four nutrients in every can of formula sold in the United States while leaving the rest of the current recipe untouched for now. The proposal, published in the Federal Register on Monday, 2 November 2026, is the opening phase of a longer review, not a final rule — and that distinction matters for parents, because nothing on store shelves changes as a result of this document alone.
At its centre is a simple claim from the agency: the science behind infant nutrition has moved on since 1998, when the current nutrient table was last comprehensively reviewed, and the rules should catch up. The proposal reviews eight of the thirty nutrients that federal law requires in infant formula. It would alter the minimum or maximum levels for four of them — iodine, vitamin A, vitamin D and manganese — and keep the existing levels for the other four in this group: chloride, potassium, selenium and sodium. The remaining nutrients will be dealt with in later phases, and the agency has also asked the public whether three ingredients that manufacturers commonly add, but that are not currently required, should become mandatory.
Health and Human Services Secretary Robert F. Kennedy Jr. announced the proposal on 29 October at an event in Des Moines, presenting it as part of Operation Stork Speed, the administration’s review of the infant formula supply, and its wider Make America Healthy Again agenda. Acting FDA Commissioner Kyle Diamantas described the move as modernising nutritional requirements for the first time in nearly thirty years. Both men framed the change as a way to give parents greater confidence in formula, with stronger standards built on current evidence rather than on rules written a generation ago.
For families, the practical message is patience. A proposed rule is an invitation to comment and a statement of what the agency intends to do, not an instruction to change what a baby is fed today. The FDA is accepting comments for 120 days from publication, with a closing date of 2 March 2027. Only after it considers those comments, completes any further phases it has planned, and publishes a final rule would manufacturers face a binding new standard — and the proposal itself suggests giving manufacturers three years to comply once the final, comprehensive rule takes effect. One paediatric nutrition expert quoted in early coverage warned that parents should not expect the recommended changes to appear on cans for several years. Anyone with a question about a particular baby’s feeding should, as always, speak to that child’s clinician rather than treating a federal proposal as personal medical guidance.
FDA Infant Formula Proposal: What Would Change for Iodine and Vitamin D
The largest proposed change, in proportional terms, concerns iodine, a mineral the body uses to make thyroid hormones that support brain development in early life. The FDA would triple the minimum iodine level, from 5 micrograms per 100 calories to 15 micrograms per 100 calories, while lowering the maximum from 75 micrograms to 50 micrograms. In other words, the agency wants to narrow the permitted band and lift its floor: formula would have to contain substantially more iodine than the current minimum demands, but could not contain as much at the top end as the present ceiling allows.
Vitamin D, the nutrient the agency’s own economic analysis identifies as the most consequential in this first group, would move in the opposite direction at both ends of its range. The minimum would double, from 1 microgram per 100 calories to 2 micrograms, and the maximum would rise from 2.5 micrograms to 3 micrograms. Vitamin D helps the body absorb calcium and phosphorus, supports bone and tooth development, and protects against rickets, the softening of bones that follows severe deficiency. The FDA links the higher minimum to reducing cases of late-onset low blood calcium in infants, a condition tied to vitamin D shortage that accounts for nearly all of the quantified benefit in its analysis. The proposal would also change how vitamin D is expressed on labels, moving from international units to micrograms, so a label that today reads in one unit would in future read in another even where the underlying amount had barely moved.
Those two nutrients illustrate the two different kinds of problem the review is trying to solve. With iodine, the concern is that the current minimum is too low to guarantee adequate intake, while the current maximum leaves more room at the top than the evidence now supports. With vitamin D, the agency’s judgement is that both ends of the range sit too low: too little risks deficiency, and the existing ceiling constrains products that could safely provide more. In both cases the FDA says it weighed the amount needed to support growth against the amount at which harm could begin, drawing on nutrient reference values, the composition of human milk, standards used in other countries, and studies published since the last review.
Vitamin A Measurement and the First-Ever Manganese Cap
Vitamin A would be measured differently and, on the agency’s numbers, set at lower levels than today. The proposal changes the unit of measurement from international units to micrograms of retinol activity equivalents, a unit that better reflects how much usable vitamin A a product actually provides. Under the new unit, the minimum would fall from the equivalent of 75 micrograms of retinol activity per 100 calories to 70 micrograms, and the maximum would fall from 225 micrograms to 120 micrograms. The proposal also provides that only preformed vitamin A — vitamin A already in its active form — would count towards the required minimum. Beta-carotene, a plant compound the body can convert into vitamin A, would no longer satisfy the requirement on its own. That is a technical change with a real consequence for how some formulas are put together, because a product that previously met the standard partly through beta-carotene would need to be reformulated or relabelled.
Manganese sees the most striking change in approach. The mineral is needed in tiny amounts for enzyme function and bone development, but the FDA notes that it can harm the developing nervous system at elevated levels, and that infants are especially vulnerable. The proposal would cut the minimum from 5 micrograms per 100 calories to 1 microgram and, for the first time, impose a maximum of 50 micrograms per 100 calories. Until now there has been no federal ceiling for manganese in formula at all. The agency acknowledges that the human studies behind its judgement can show associations rather than proving cause and effect outright, and it points to the wide gap between manganese levels in some soy-based formulas and the much lower levels found in human milk as part of the reason a ceiling is now warranted. Whether that ceiling would force reformulation of particular products will depend on their current recipes, which is precisely the kind of detail the comment period is designed to surface.
The four nutrients whose levels would stay exactly as they are in this phase — chloride, potassium, selenium and sodium — are not being ignored. The FDA says it carried out a full assessment of each and concluded that the present levels still reflect the best available evidence on infant needs and safe intake. That matters because it shows the review is not a blanket tightening: where the agency found the old numbers still sound, it proposed leaving them alone, at least for now.
Why the FDA Says the Rules Had Not Kept Pace Since 1998
To understand why a nutrient table can sit unchanged for almost thirty years, it helps to know how the system was built. Congress passed the Infant Formula Act in 1980 after a chloride-deficient soy formula sickened roughly 150 infants in the late 1970s, and the law set minimum levels for a list of nutrients that every formula had to contain. A later law, passed in 2022 after the national formula shortage of that year, requires the FDA to review the nutrient table every four years where appropriate. The present proposal is the agency’s answer to that duty, organised as a phased review rather than a single attempt to redo all thirty nutrients at once.
The phased design is both the proposal’s strength and its most criticised feature. Splitting the work lets the agency move first on the nutrients where it believes the evidence is clearest, while giving itself time to assess the rest. But it also means that parents, manufacturers and clinicians will live for years with a nutrient table that is partly new and partly old, and that the full picture — including protein, fat, iron and other nutrients still to come — will not be visible until later phases are published. Paediatric experts quoted in early coverage praised the first phase as careful and well thought out, while warning that the staged timetable means the changes will take a long time to reach the shelf. That tension, between getting the first step right and finishing the whole job, is likely to run through the comment period.
The proposal also sits alongside a separate strand of the same initiative: testing formula for contaminants. Alongside the nutrient proposal, the department released updated results from its testing of formula for heavy metals and other contaminants, describing the latest batch as reassuring, with most samples showing low or undetectable levels, and pointing to a public dashboard where the data can be inspected. That testing programme, under the department’s Closer to Zero effort, is distinct from the nutrient rules, but the agency presents both as parts of a single promise: that formula should be both nutritionally adequate and as free of contaminants as current methods allow.
Costs, Benefits and the Long Road to a Final Rule
Every major federal rule must carry an estimate of what it will cost and what it will gain, and this one is no exception. The FDA puts the annualised benefits at about 80.9 million dollars, using a 7 per cent discount rate, within a range of 18.8 million to 171.7 million dollars. Almost all of that figure comes from fewer cases of late-onset low blood calcium linked to vitamin D deficiency. The agency itself calls the headline figure a lower bound, because it could not put a dollar value on the other effects it expects, such as better iodine intake and reduced exposure to excess vitamin A and manganese. Against that, it puts annualised costs at roughly 17.6 million dollars, mostly the expense to manufacturers of relabelling products, reformulating recipes and filing required notices with the agency.
Those numbers should be read with care. A benefit estimate is not money saved in any particular family’s pocket, and it rests on assumptions about how many infants would otherwise have developed the conditions in question and how far the new levels would reduce that number. The wide range — from under 19 million to over 171 million dollars — shows how sensitive the answer is to those assumptions. What the estimate does usefully show is the agency’s own ranking of effects: vitamin D dominates the quantified case, while the other nutrients are justified mainly on nutritional and safety grounds that resist easy conversion into dollars.
Timing is equally important, and here the proposal is explicit that the road is long. A final rule, once published, would take effect 60 days later, but manufacturers would have three years to comply, counted from the effective date of the final rule that completes the phased review. The agency’s analysis assumes benefits would begin in 2031. It also says it plans an external peer review of its scientific work. In practice, then, the earliest realistic date at which a parent might pick up a can made to the new standard is years away, and later phases could still alter the timetable. That is not a flaw in the process so much as its nature: changing a national nutrition standard for the most vulnerable consumers is deliberately slow, precisely because mistakes would be costly.
What Comes Next: Later Phases, New Ingredients and Your Chance to Comment
The second phase of the review will address a dozen further nutrients, including vitamin E, the B vitamins thiamine, riboflavin, niacin, pantothenic acid, vitamin B6 and vitamin B12, folic acid, biotin, vitamin C, choline and inositol. A third phase will look at protein, fat, linoleic acid, iron, copper, zinc, calcium, phosphorus, magnesium and vitamin K, among others. Separately, the agency is asking whether three ingredients that are not currently required — the fatty acids DHA and ARA, and L-carnitine, which helps the body break down fats — should become mandatory, on the grounds that there is evidence they contribute to early brain development and health. Manufacturers already add DHA and ARA to many formulas, so making them required would matter most for products that currently leave them out.
For parents, clinicians, manufacturers and researchers, the immediate opportunity is the comment period itself. Comments must be submitted by 2 March 2027, through the Federal Register notice under docket number FDA-2026-N-10832, which is the official version of the proposal. Earlier department announcements gave a different deadline and docket number, and readers should rely on the Federal Register notice rather than on press-release summaries. Comments that point to specific studies, flag practical problems with a proposed level, or identify products that would be unusually affected are the ones most likely to influence the final rule, because the agency must respond to the substantive points raised.
The proposal’s reception so far suggests the debate will be detailed rather than purely political. Formula manufacturers, represented by their industry council, and the American Academy of Pediatrics did not immediately respond to requests for comment in early coverage, which leaves their formal positions for the comment record rather than the news cycle. That is, in a sense, how the system is supposed to work: the proposal is published, the evidence is laid out, and the argument happens in public, on the record, before anything becomes law. For now, the cans on the shelf are made to the old rules, the new rules are only a proposal, and the most useful thing any reader can do with this story is to know which of those two facts applies — and how long the gap between them is likely to last.
Sources
USN reviewed reporting from multiple outlets for this story. Read more from Nutrition Insight, The San Francisco Inquirer and Being Healthy.