The Food and Drug Administration has proposed the first update to the nutrient rules for infant formula in the United States since 1998, opening a new chapter for the food that feeds millions of American babies. Announced on Thursday, October 29, 2026, in Des Moines, Iowa, the proposal is the first of three planned rules that will, over time, review all 30 nutrients the federal government currently requires in formula sold in the United States.
Nothing changes in the can on a supermarket shelf today. The announcement is a proposed rule, not a final one, and the agency itself says the review will proceed in phases, with public comment, peer review and a single comprehensive final rule at the end. But for parents, paediatricians and manufacturers, it is the most significant rewrite of the formula rulebook in nearly three decades — and the first test of whether the Trump administration's Operation Stork Speed initiative will change what is actually inside the bottle.
Health and Human Services Secretary Robert F. Kennedy Jr. announced the proposal at the Amanda the Panda Children Center in Des Moines, as part of President Donald Trump's Operation Stork Speed initiative and the broader Make America Healthy Again agenda. Operation Stork Speed was launched in March 2025 as the first comprehensive review of infant formula nutrients in decades, covering nutrient content, contaminant testing and label transparency.
“Parents deserve confidence in every bottle they feed their baby,” Kennedy said in the department's announcement. “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.”
FDA Acting Commissioner Kyle Diamantas framed the move in similar terms. “Under President Trump's leadership, we are modernizing our nutritional requirements for infant formula for the first time in nearly three decades,” he said. “By doing this, we are stepping up to guarantee that American babies receive world class, gold-standard nourishment from day one.”
Alongside the proposed rule, the FDA published its latest chemical contaminant testing results for infant formula. Most samples tested had low or non-detectable levels of chemical contaminants, the agency said, consistent with findings released earlier in 2026. To make those results easier to find, it launched a new Infant Formula Testing Webpage and an Infant Formula Chemical Contaminants Dashboard, and said it is working, under its Closer to Zero initiative, toward action levels for certain contaminants, with monitoring to continue.
Infant formula in the United States is not approved by the FDA before it goes on sale in the way a drug is. Manufacturers notify the agency before selling a new formula, and every formula must meet the federal nutrient requirements — the same framework that has been in place, in substance, since 1998. That is why a proposed rule matters even though it changes nothing immediately: once a final rule is issued, every manufacturer will have to reformulate, relabel or both to comply.
The FDA's review is being conducted in three phases so that it can advance and receive public comment on evidence-based proposals as each phase is completed, rather than waiting until the whole review is finished. This first phase covers four of the 30 required nutrients. Later phases will assess the remaining required nutrients, potential new nutrient requirements and carbohydrate sources. Only after all three phases will the agency consolidate the changes into a single comprehensive final rule.
The agency is also asking for public input on ingredients that are not currently required but are commonly added by manufacturers because of their nutritional value. The evidence, it says, supports the idea that nutrients such as arachidonic acid (ARA), docosahexaenoic acid (DHA) and L-carnitine contribute to neurodevelopmental health in infancy — a question that could shape whether a future phase adds them to the required list.
Paediatric experts quoted in coverage of the announcement urged parents not to expect quick changes. Dr Steven Abrams, a paediatrician and professor at the University of Texas' Dell Medical School who specialises in infant nutrition, said the proposed changes would not appear on formula containers immediately and could take several years to reach shelves, as the rule must pass external peer review and a final rulemaking process first.
The four nutrients updated in this first phase are iodine, manganese, vitamin A and vitamin D. The proposal would triple the required amount of iodine, from 5 micrograms to 15 micrograms, and set a new upper limit of 50 micrograms. Iodine supports thyroid function and brain development, and the higher floor reflects updated science on how much infants need.
Manganese moves in the opposite direction. The proposal reduces the minimum required amount from 5 micrograms to 1 microgram per 100 calories and establishes a new limit of 50 micrograms. Manganese is a trace mineral that supports enzyme function and bone development, but infants need only small amounts of it.
Vitamin A would fall slightly, from 250 international units per 100 calories to 233 international units. Vitamin D, by contrast, would rise substantially: the proposal doubles the minimum required amount from 1 microgram to 2 micrograms and increases the maximum allowed to 3 micrograms. Vitamin D helps build bones and teeth and helps prevent rickets, or soft bones, and paediatric experts described the vitamin D increase as the most consequential change in this first set of recommendations.
Four other requirements would be reaffirmed unchanged: chloride, potassium, selenium and sodium. The proposal would also change the units of measure for two nutrients. The FDA estimates that implementing the changes, through reformulating and relabelling products, will cost manufacturers between $8.4 million and $31.7 million a year, according to Bloomberg Law's account of the proposal.
The administration presented the announcement as a trust-building measure. Kennedy's central claim was that parents should be able to have confidence in every bottle, and that testing results would now be put directly in parents' hands through the new dashboard rather than buried in agency reports. Diamantas echoed that theme, saying the agency was stepping up to guarantee gold-standard nourishment from day one.
Paediatric reaction was more measured. Abrams welcomed the direction of the review but stressed the timeline: a proposal is not a product change, and families should not look for new labels tomorrow. His caution reflects how federal rulemaking works — a proposed rule invites comment, undergoes peer review of the science behind it, and only then becomes a final rule that manufacturers must follow.
Other critics were sharper. Writing about the announcement, physician and commentator Dr Celine Gounder argued that neither part of it addresses botulism, the bacterial risk that put infants in hospital last year. Last year, 48 infants across 17 states were hospitalised with botulism after drinking powdered formula from ByHeart, she noted, yet the proposed rule covers nutrients and the contaminant data covers metals such as lead and arsenic and chemicals such as PFAS — not bacteria. The administration also did not mention cronobacter or botulism outbreaks in its announcement, according to contemporaneous coverage.
Gounder also reported that former FDA employees told KFF Health News that Operation Stork Speed was built by listing infant formula work already under way and branding it as a new push, and noted that last month Abbott agreed to pay $385 million to settle Justice Department and state claims that it sold formula from an unsanitary plant and billed federal programmes for it. Those points, critics say, are the gap between a nutrient update and a food-safety overhaul — and they are likely to dominate the public comments the FDA will now receive.
For most American families, infant formula is not a niche product. It is, for millions of babies, either the sole source of nutrition or a supplement to breastfeeding, and its nutrient profile is set by law rather than by the market. A rule written in 1998 was based on the science of that era; updating it to reflect what researchers now know about iodine, vitamin D and brain development is, on its own terms, a meaningful change — even if it arrives one nutrient group at a time.
The timing matters too. The proposal lands days before the November 3 midterm elections, as part of an administration health agenda that has put food and children's health at its centre. Whether voters notice a proposed rule about micrograms per 100 calories is another question, but the political framing is unmistakable: this is being sold as putting babies' health first, and as the first comprehensive formula review in a generation.
What will decide whether the rule matters in practice is what happens next. If the later phases follow — covering the remaining nutrients, possible new requirements and carbohydrate sources — and if the final rule survives peer review and industry pushback, the cans on shelves in a few years' time will be measurably different from today's. If the process stalls, or if the final rule is watered down, the announcement will be remembered mainly as a press release. The comment period, which runs until February 26, 2027, is where that fight will first play out.
The immediate next step is public comment. Electronic comments can be submitted at regulations.gov under docket FDA-2026-56789, and written comments go to the FDA's Dockets Management Staff in Rockville, Maryland, quoting the same docket number. The deadline is February 26, 2027. The FDA says it will run an external peer review of the science behind any final rule.
After that, the agency will publish the second and third phases of its review, covering the remaining required nutrients, potential new nutrient requirements and carbohydrate sources, and then consolidate everything into a single comprehensive final rule. Manufacturers will then have to reformulate and relabel to meet the new requirements, at the estimated annual cost noted above. Parents, in the meantime, are being told by paediatric experts that nothing about the formula they buy today has changed — and that they should keep feeding their babies as their doctors advise, rather than waiting for a new label.
The contaminant side of the announcement will also continue. The FDA says it will keep monitoring contaminant levels, work toward action levels for certain chemicals under Closer to Zero, and update its new dashboard as more testing results come in. Whether it also moves on bacterial testing — the issue critics say this announcement sidestepped — will be one of the clearest tests of how far Operation Stork Speed intends to go.
The FDA proposed the first update to infant formula nutrient requirements since 1998. The first phase updates iodine, manganese, vitamin A and vitamin D, reaffirms four other requirements, and asks for input on ARA, DHA and L-carnitine. It is a proposed rule, not a final one.
No. Nothing changes on shelves yet. The proposal must go through public comment, peer review and a final rulemaking process, and paediatric experts say the changes could take several years to appear on containers.
Iodine rises from 5 to 15 micrograms, with a new upper limit of 50 micrograms, and vitamin D doubles from a minimum of 1 to 2 micrograms, with a maximum of 3 micrograms. Manganese falls from a minimum of 5 to 1 microgram per 100 calories, and vitamin A falls from 250 to 233 international units per 100 calories.
Comments are open until February 26, 2027, at regulations.gov under docket FDA-2026-56789, or in writing to the FDA's Dockets Management Staff in Rockville, Maryland, quoting that docket number.
The FDA released new testing data showing most samples had low or non-detectable chemical contaminants, and launched a public dashboard. Critics note the announcement does not address bacterial contamination such as botulism, which hospitalised 48 infants across 17 states last year after powdered formula from ByHeart.
Related coverage on US News Pulse: Infant formula botulism testing petition seeks FDA rule after babies sickened; Darwin's cat food Salmonella alert: FDA warns two lots after cat hospitalised; Trader Joe's E. coli outbreak ends as FDA closes case that sickened 50 people.
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