FDA Proposes First Major Infant Formula Nutrient Update in 30 Years

On October 29, the U.S. Food and Drug Administration announced a proposed rule that would revise the nutrient requirements for infant formula sold in the United States. The rule constitutes the first phase of a three-phase review that will eventually address all 30 nutrients currently mandated for formula. The initial phase targets four nutrients—iodine, manganese, vitamin A, and vitamin D—and reaffirms existing limits for chloride, potassium, selenium and sodium. The agency also plans to solicit public comment on optional ingredients such as arachidonic acid (ARA), docosahexaenoic acid (DHA) and L-carnitine.

National Law ReviewFDA proposes rule updating nutrient requirements for infant formula CNNFDA Proposes Changes to Infant Formula Nutrition Standards

The review is part of the federal “Operation Stork Speed” initiative launched in March 2025, aiming to modernize infant-nutrition standards that have not been comprehensively updated since 1998. Under the Department of Health and Human Services (HHS), the FDA conducts a quadrennial review of the nutrient table, but this is the first “major” overhaul in nearly three decades. The agency released new chemical-contaminant testing data showing that most formula samples contain low or non-detectable levels of contaminants.

FDA Proposes Changes to Infant Formula Nutrition Standards

• Iodine: minimum requirement increased threefold, from 5 µg to 15 µg per 100 kcal; new upper limit set at 50 µg.

CNN

• Manganese: minimum reduced from 5 µg to 1 µg per 100 kcal; upper limit established at 50 µg.

CNN

• Vitamin A: requirement lowered from 250 IU to 233 IU per 100 kcal, with units changing from IU to retinol activity equivalents (RAE).

CNN

• Vitamin D: minimum doubled from 1 µg to 2 µg per 100 kcal; maximum raised to 3 µg.

CNN

• The rule maintains existing specifications for chloride, potassium, selenium and sodium (ABC News, CNN, DailyFly).

National Law Review

• The FDA currently mandates 30 nutrients, with minimum amounts for all and maximum limits for 10 of them.

FDA proposes rule updating nutrient requirements for infant formula

U.S. Health and Human Services Secretary Robert F. Acting FDA director Kyle Diamantas highlighted the agency’s intent to gather input on nutrients not yet required, noting evidence that ARA, DHA and L-carnitine may support neurodevelopment. Pediatrician-researcher Dr. Steven Abrams** called the first-phase changes “really well done” but warned that the piecemeal approach means revised formulas may not appear on shelves for several years.

CNN

• “Generally, they're believed to be pro-inflammatory,” — Dr. Marty Makary, then-fda commissioner

FDA proposes rule updating nutrient requirements for infant formula

• “There’s evidence that these nutrients contribute to neurodevelopment and health in infancy. And we want to hear from the scientific community, from clinicians, from industry, and the public as we consider whether or not to make these nutrients mandatory in the U.S. infant formula supply,” — Kyle Diamantas

CNN

The FDA will accept written comments on the proposed rule through February 26, 2027. Submissions may be filed via Regulations.gov using docket number FDA-2026-56789 (DailyFly, NatLawReview). After the comment period, the agency plans to consolidate the three phases into a single comprehensive final rule.

FDA Proposes Changes to Infant Formula Nutrition Standards