Why It Matters
Infant formula makers would face new nutrient floors and ceilings and mandatory relabeling under a Food and Drug Administration proposal published November 2, with comments due March 2, 2027. Compliance would not required until three years after a final omnibus rule takes effect, meaning benefits would not begin accruing until 2031.
The nutrient levels now in force were set in 1985, with only selenium added since then in 2015. HHS framed the proposal as part of Operation Stork Speed, announced by HHS and FDA on March 18, 2025, and the Make America Healthy Again initiative.
The agency says the purpose is "to ensure that infant formula provides adequate nutrition to support the growth and development of infants from birth through 12 months of age while avoiding excessive intakes that could pose health risks."
This is the first phase of a three-rule sequence covering all 30 required nutrients; FDA intends to issue subsequent proposed rules before issuing one omnibus final rule. CNN reported that pediatrician Steven Abrams called the review overdue but said the phased process could mean changes take several years to reach formula cans. HHS Secretary Robert F. Kennedy Jr. said the administration seeks stronger nutrient requirements and testing transparency.
The proposal addresses four nutrients, with the following changes to 21 C.F.R. § 107.100:
- Iodine: minimum raised from 5 µg/100 kcal to 15 µg/100 kcal; maximum lowered from 75 µg/100 kcal to 50 µg/100 kcal.
- Vitamin A: minimum lowered to 70 µg RAE/100 kcal; maximum lowered to 120 µg RAE/100 kcal; beta-carotene excluded from meeting the minimum and maximum.
- Vitamin D: minimum raised to 2 µg/100 kcal; maximum raised to 3 µg/100 kcal.
- Manganese: minimum lowered from 5 µg/100 kcal to 1 µg/100 kcal; a new maximum of 50 µg/100 kcal established for the first time.
Today, vitamin A and D levels in 21 C.F.R. § 107.100 are expressed in International Units and manganese carries no maximum; the proposed rule would switch vitamin A to Microgram Retinol Activity Equivalents and vitamin D to micrograms, add a new paragraph (g) requiring vitamin A levels be met through preformed vitamin A only, and establish the first manganese ceiling.
Under 21 C.F.R. § 184.1245 today, beta-carotene may be used as a source of vitamin A in infant formula; the proposed rule would list infant formula among the foods where beta-carotene may be used at current good manufacturing practice levels, and would bar beta-carotene from counting toward vitamin A minimum and maximum levels in infant formula.
Under 21 C.F.R. § 107.10 today, International Units are the primary labeling unit for vitamins A and D; the proposed rule would flip the primary unit for vitamin A to Microgram Retinol Activity Equivalents and for vitamin D to micrograms.
All 326 UPCs of infant formula must relabel regardless of whether their nutrient levels change, because the mandatory unit conversion applies to every product. FDA estimates the relabeling cost per UPC at $836, with a total relabeling cost of $272,666 at the primary estimate.
FDA estimates annualized benefits of $80.93 million per year and annualized costs of $17.64 million per year at a 7 percent discount rate in 2025 dollars over a 10-year period from 2027 to 2036. The primary quantified benefit is avoided healthcare costs from vitamin D deficiency-induced late-onset hypocalcemia, which FDA describes as "a lower bound on the rule's total societal benefits."
FDA says benefits are expected to accrue disproportionately to infants enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children, who represent approximately 50 percent of formula-fed infants in the United States; costs are borne by manufacturers.
FDA says it cannot determine with certainty the magnitude of reformulation costs that small infant formula manufacturers would incur, and finds the proposed rule "may have a significant economic impact on a substantial number of small entities."
FDA also asks commenters to address whether DHA and ARA should be formally required; whether alpha-linolenic acid should be added as a required nutrient; and whether current iron levels should be maintained, increased, or reduced in light of emerging evidence on iron's role in neurodevelopment and gut microbiome development.
The Bottom Line
Comments on the proposed rule, docketed as FDA-2026-N-10832, are due by March 2, 2027.
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