The Food and Drug Administration on Thursday proposed the first major update to the nutrient requirements for infant formula in nearly 30 years, a rule that would raise the minimum amounts of vitamin D and iodine required in infant formula sold in the United States while lowering the ceilings for vitamin A and manganese.
Health Secretary Robert F. Kennedy Jr. announced the proposed rule at Amanda the Panda Children Center in Des Moines, Iowa, on Oct. 29, alongside new FDA testing data that the agency says found low or non-detectable levels of chemical contaminants in most formula samples. “Parents deserve confidence in every bottle they feed their baby,” Kennedy said in an HHS announcement.
The proposal is not final. It opens a public comment period, and the FDA says any changes would not be required in stores for years.
What would the FDA change in infant formula?
The rule covers eight of the 30 nutrients federal law requires in infant formula. According to the FDA’s summary, it would change the required levels of four of them and keep the current limits for the other four: chloride, potassium, selenium and sodium.
- Vitamin D: the minimum would double, from 1 microgram (40 IU) to 2 micrograms (80 IU) per 100 calories, and the maximum would rise from 2.5 to 3 micrograms.
- Iodine: the minimum would triple, from 5 to 15 micrograms per 100 calories, while the maximum would fall from 75 to 50 micrograms.
- Vitamin A: the minimum would dip slightly, to 70 micrograms retinol activity equivalents per 100 calories, and the maximum would drop sharply, from 225 to 120 micrograms. Only preformed vitamin A, not beta-carotene, would count toward those limits.
- Manganese: the minimum would fall from 5 to 1 microgram per 100 calories, and the FDA would set a maximum of 50 micrograms for the first time.
The rule would also switch vitamin A and vitamin D labeling from international units to micrograms, and update formula labels to match the new levels.
Why does the FDA say the update is needed?
The FDA last completed a comprehensive scientific review of formula nutrients in 1998, the proposed rule says. The current requirements date to a 1985 regulation that put the Infant Formula Act of 1980 into effect.
The agency says vitamin D is essential for calcium absorption and bone growth, and that deficiency can cause rickets and dangerously low blood calcium in infants. The higher iodine floor is meant to reduce the risk of inadequate intake, while the new caps on vitamin A and manganese are aimed at avoiding excessive exposure, according to the document.
The FDA estimates the changes would produce $80.9 million a year in benefits under its primary estimate, mostly from fewer medical costs tied to vitamin D deficiency, against about $17.6 million a year in costs for manufacturers to reformulate and relabel their products. Both figures use a 7% discount rate over 10 years.
Is this the final word on formula nutrients?
No. The FDA describes this as the first of three planned proposals. Later phases will review the remaining required nutrients, possible new requirements and carbohydrate sources, and the agency says it plans to combine all of the changes into a single final rule.
In this round, the FDA is also asking the public whether it should require ingredients that many manufacturers already add voluntarily, including the fatty acids DHA and ARA and the nutrient L-carnitine. The agency says there is evidence those nutrients contribute to brain development in infancy, but it is not proposing to require them yet.
Under the proposal, a final rule would take effect 60 days after it is published, and manufacturers would then have three years to comply.
What did the new contaminant testing find?
Alongside the rule, the FDA posted updated results from its infant formula testing program, which checks for lead, arsenic, cadmium, mercury, PFAS “forever chemicals,” pesticides and plastic-related chemicals called phthalates. The agency’s testing page says it has examined 312 samples from 16 brands.
“Across the products tested, the majority of infant formula samples had undetectable or very low levels of contaminants,” the FDA said, adding that some samples had values that triggered follow-up testing and talks with manufacturers. The agency says it is working toward setting “action levels” for certain contaminants in formula under its Closer to Zero initiative, and it launched a new online dashboard of the results.
What should parents do now?
Nothing needs to change at the store. In its question-and-answer guidance, the FDA says infant formulas currently on the U.S. market “remain safe for babies.” Parents with questions about which formula is right for their child should talk with a pediatrician.
The public can comment on the proposal at regulations.gov under docket FDA-2026-N-10832. HHS lists a comment deadline of Feb. 26, 2027, while the rule text sets the deadline at 120 days after its scheduled Nov. 2 publication in the Federal Register. The announcement is part of the administration’s Operation Stork Speed formula initiative. It comes a day after HHS let pharmacies compound six unapproved peptides under an interim policy.
Key Takeaways
- The FDA proposed the first major update to infant formula nutrient requirements since its last full review in 1998.
- The rule would double the minimum vitamin D level, triple the minimum iodine level, cut the maximum for vitamin A and set the first cap on manganese.
- It is a proposal: comments are open, two more phases are coming, and manufacturers would get three years to comply after a final rule.
- New FDA testing found low or non-detectable contaminant levels in most formula samples, and the agency says formulas on the market remain safe.
Frequently Asked Questions
Is the new infant formula rule final?
No. The FDA issued a proposed rule on Oct. 29, 2026. It is open for public comment, and the agency plans two more proposals before issuing one combined final rule.
Which nutrients would change in infant formula?
The proposal would change required levels of vitamin D, iodine, vitamin A and manganese, and keep current limits for chloride, potassium, selenium and sodium.
Should I switch my baby’s formula?
No. The FDA says infant formulas currently sold in the U.S. remain safe. Talk with your pediatrician before changing formulas.
When would formula makers have to comply?
Under the proposal, a final rule would take effect 60 days after publication, and manufacturers would have three years after that to reformulate and relabel.
Featured image: A scoop of powdered baby formula. Illustrative photo; it does not show a specific brand affected by the rule. (Photo by Ajay Suresh, CC BY 2.0, via Wikimedia Commons)
