FDA Proposal Calls for More Vitamin D and Iodine in Infant Formula, While Existing Products Stay Safe

Infant formula sold in the United States would need higher amounts of vitamin D and iodine, tighter limits on vitamin A, and a new ceiling for manganese under a proposed rule announced by the Food and Drug Administration. The plan is the first of three stages in the agency's first full review of formula nutrient standards since 1998, according to the Department of Health and Human Services.

The proposal is not final. The FDA says the changes are not tied to safety problems and that formulas currently on the market remain safe. Parents do not need to switch products.

For infants who depend on formula as their only food for months, minimum and maximum nutrient levels are not just technical details. They determine much of what a baby receives, and the standards behind every can on the shelf have not been comprehensively updated in nearly three decades.

Four Nutrients Would Be Revised

The rule would change requirements for four of the 30 nutrients in formula and would leave chloride, potassium, selenium and sodium at their current levels, according to the FDA summary. No nutrients would be added or removed. All measurements are based on 100 calories of formula.

Vitamin D would undergo the biggest shift. The minimum would rise from 1 to 2 micrograms, while the maximum would increase from 2.5 to 3 micrograms. Current formulas contain slightly less vitamin D than recommended, and many parents add extra, according to Scripps News. The higher standard could save nearly $81 million a year in costs linked to late-onset hypocalcemia, or low blood calcium, the report said.

Iodine, which helps the body produce thyroid hormone, would increase from a 5-microgram minimum to 15 micrograms, tripling the floor. The upper limit would drop from 75 to 50 micrograms. Manganese would get its first maximum level, set at 50 micrograms, while its minimum would fall from 5 to 1 microgram.

Vitamin A would be set at a range of 70 to 120 micrograms, down from 75 to 225 micrograms. Vitamin A and vitamin D would both be measured in micrograms instead of international units. Only preformed vitamin A, not beta-carotene, would count toward the vitamin A limits.

The FDA is also seeking public comment on whether DHA, ARA and L-carnitine, which formula makers often add but are not currently required, should become mandatory.

Pediatric Specialists Call It a Step Forward, but Say It Will Take Time

Dr. Steven Abrams, a pediatrician and professor at the University of Texas at Austin's Dell Medical School, said the vitamin D increase is the most important change in the first group of proposals, according to Scripps News. He described the initial phase as carefully considered, but said the updates are "not going to be something that'll show up on the can of formula potentially for several years."

That delay is built into the process. The FDA plans to roll the three phases into one final rule, which would take effect 60 days after publication. Manufacturers would then have a proposed three years to reformulate and relabel their products. The agency said there would be no immediate impact on the WIC program.

Phase 2, which covers vitamin E, several B vitamins, folic acid, biotin, vitamin C, choline and inositol, is already underway. Abrams said proposals for those nutrients could arrive within the next year or so. Phase 3 will address protein, fat, iron, calcium and other nutrients, along with ingredients such as DHA and ARA, and no schedule has been released. Final values could still change after public comment.

"Parents deserve confidence in every bottle they feed their baby," HHS Secretary Robert F. Kennedy Jr. said when announcing the proposal. The FDA also released new contaminant testing data showing that most formula samples had low or undetectable levels of the chemicals tested, matching results issued earlier this year.

What Parents Should Do Now

This proposal does not change how families should feed babies right now. Parents should keep using the formula recommended by their pediatrician and should not change brands, add nutrients, or adjust vitamin D drops on their own because of the news. Supplement needs depend on how much formula a baby drinks and whether the baby also breastfeeds.

The FDA still advises against homemade formula, and health officials warn against watering down formula to make supplies last longer. Both can create dangerous nutrient imbalances. Families that are having trouble affording or finding formula can contact their local WIC office or pediatrician for help.

Parents of babies who use specialty formulas for allergies, prematurity or medical conditions should ask their care team how future changes may apply, since some exempt formulas follow different rules. Signs of illness in an infant, such as poor feeding, repeated vomiting, fewer wet diapers or unusual sleepiness, require prompt medical attention regardless of the formula used.

Supply concerns also remain. The FDA said it will coordinate with the U.S. Department of Agriculture and monitor formula supplies as manufacturers prepare. Many families still remember the formula shortage of 2022, and any reformulation will be watched closely for its effect on availability.

The public can submit comments on the proposal through regulations.gov until Feb. 26, 2027. For now, the rule points to what infant formula may look like in the future, and the cans already in the pantry remain safe to use.

Key Questions Answered

What did the FDA propose? New required levels for vitamin D, iodine, manganese and vitamin A in infant formula, while leaving chloride, potassium, selenium and sodium unchanged.

Is the formula on store shelves still safe? Yes. The FDA says current formulas remain safe and families do not need to change products.

When would the changes take effect? Not for years. A final rule must still be issued, and manufacturers would then have a proposed three years to comply.

Why increase vitamin D? Current formula has slightly less vitamin D than recommended, and the change could reduce costs tied to low blood calcium.

Should I add vitamin D drops to my baby's formula? Ask your pediatrician. Needs depend on how much formula your baby drinks and whether the baby also breastfeeds.

How can I comment on the proposal? Through regulations.gov until Feb. 26, 2027.