FDA proposes new iodine, vitamin A and D limits for infant formula

The FDA has proposed raising the minimum iodine and vitamin D content of infant formula, lowering the ceilings for iodine and vitamin A, and setting a first-ever upper limit for manganese, the first phase of what the agency calls its most thorough review of formula nutrients since 1998.¹ Published October 29, 2026, the proposed rule addresses 8 of the 30 nutrients currently required in infant formula marketed in the United States and stems from the HHS and FDA initiative known as Operation Stork Speed.¹

“For many children, infant formula is their only source of nutrition,” FDA Commissioner Martin A. Makary, MD, MPH, said when the agency opened the review in May 2025. “That’s why it’s absolutely crucial to continually assess the nutrition standards and incorporate gold standard science to ensure we are providing the safest, most effective nutrition possible.”²

The FDA stressed that the proposed changes are not driven by safety concerns and that formulas currently on the market remain safe for infants.¹

Proposed iodine, manganese, and vitamin A and D limits in infant formula

Four nutrients would see revised limits, all expressed per 100 kcal.¹ The iodine minimum would triple while its maximum falls, manganese would gain its first upper limit, and the vitamin D range would shift upward.¹ Vitamin A and vitamin D would move from IU to metric units, and only preformed vitamin A, not beta-carotene, would count toward vitamin A limits.¹ Label requirements would be updated to match.¹

Iodine: current 5–75 µg; proposed 15–50 µg per 100 kcal.¹

Manganese: current minimum 5 µg with no maximum; proposed 1–50 µg per 100 kcal.¹

Vitamin A: current 75–225 µg RAE (250–750 IU); proposed 70–120 µg RAE per 100 kcal, preformed vitamin A only.¹

Vitamin D: current 1–2.5 µg (40–100 IU); proposed 2–3 µg (80–120 IU) per 100 kcal.¹

Sodium, potassium, chloride, and selenium levels unchanged

After its evidence review, the FDA concluded that current specifications for 4 nutrients remain appropriate and proposed to retain them.¹ Those are sodium at 20 to 60 mg, potassium at 80 to 200 mg, chloride at 55 to 150 mg, and selenium at 2 to 7 µg per 100 kcal.¹

Why the FDA is updating infant formula nutrient requirements

Federal regulations require infant formula to contain 30 nutrients, each with a minimum level and 10 with a maximum.³ The Federal Food, Drug, and Cosmetic Act directs the agency to review those requirements every 4 years as appropriate, but its last comprehensive review was in 1998.¹,³

For each nutrient in this phase, the FDA evaluated nutrient reference values, human milk composition, international formula standards, clinical literature published since 1998, and comments submitted to a 2025 request for information.¹ The full review will undergo independent peer review.¹

DHA, ARA, iron, and protein deferred to later phases

The proposal neither adds nor removes any required nutrient.¹ It does, however, request input on arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine, which are not currently required but are commonly added by manufacturers; the FDA said evidence supports their contribution to neurodevelopmental health in infancy.¹

A second phase, now underway, covers vitamin E, the B vitamins, folic acid, biotin, vitamin C, choline, and inositol.¹ A third phase, conducted by an outside organization under FDA oversight, addresses protein, fat, linoleic acid, iron, copper, zinc, calcium, phosphorus, magnesium, and vitamin K, plus potential requirements for DHA, ARA, alpha-linolenic acid, and L-carnitine.¹ Each phase is expected to yield its own proposed rule.¹

Compliance timeline and implications for pediatric practice

The FDA plans to fold all 3 phases into a single final rule that would take effect 60 days after publication, with a proposed compliance date 3 years after that for manufacturers to reformulate and relabel.¹ Comments on this proposal will be accepted for 120 days after Federal Register publication under docket FDA-2026-N-10832.¹ The agency said the changes would have no immediate effect on the WIC program and that it will coordinate with the USDA and monitor supply during any transition.¹

For clinicians, little changes in the near term: formulas on shelves need not change for years, and the FDA says they remain safe to use.¹ The proposal also defers the most debated questions, including iron, protein, and whether to require DHA and ARA, to later phases without a published timeline, and final values could shift after public comment and peer review.¹

References

1. US Food and Drug Administration. Infant formula notice of proposed rulemaking: infant formula nutrient requirements. Updated October 29, 2026. Accessed October 29, 2026. https://www.fda.gov/food/infant-formula-homepage/infant-formula-notice-proposed-rulemaking-infant-formula-nutrient-requirements

2. HHS, FDA initiate comprehensive review of nutrients in infant formula. News release. US Food and Drug Administration. May 13, 2025. Accessed October 29, 2026. https://www.fda.gov/news-events/press-announcements/hhs-fda-initiate-comprehensive-review-nutrients-infant-formula

3. Food and Drug Administration. Infant formula nutrient requirements; request for information. Fed Regist. 2025;90:20475-20477. Accessed October 29, 2026. https://www.federalregister.gov/documents/2025/05/14/2025-08419/infant-formula-nutrient-requirements-request-for-information