FDA proposes updates to eight infant formula nutrient requirements

On October 29, 2026, the FDA published a proposed rule that, if finalized, would update or reaffirm specifications for eight of the 30 nutrients required in infant formula.

The notice is the first of three planned review phases and concentrates on those eight nutrients. Later phases are to cover the remaining required set, possible new requirements, and carbohydrate sources. The agency intends to consolidate resulting changes into a single comprehensive final rule. The review is a priority under Operation Stork Speed and a duty under the Federal Food, Drug, and Cosmetic Act, which directs the FDA to review infant formula nutrient requirements every four years, as appropriate. For each nutrient, the process evaluates nutrient reference values, human milk composition, international infant formula standards, and clinical literature since the FDA’s last comprehensive review in 1998, and it also considered comments from a 2025 Request for Information. Under the Information Quality Act, the agency will submit the comprehensive infant formula nutrient review to independent peer review. Comments on the proposed rule are due until 120 days from the date it is published in the Federal Register.

In the October 29, 2026 proposed rule, the FDA’s proposed minimum iodine level for infant formula would rise from 5 µg/100 kcal to 15 µg/100 kcal, and the proposed maximum would fall from 75 µg/100 kcal to 50 µg/100 kcal. For manganese in infant formula, the same proposed rule would lower the minimum from 5 µg/100 kcal to 1 µg/100 kcal and set a maximum of 50 µg/100 kcal. Vitamin A would move from International Units to microgram retinol activity equivalents; the proposed minimum would fall from 250 IU (75 µg RAE)/100 kcal to 70 µg RAE/100 kcal and the proposed maximum from 750 IU (225 µg RAE)/100 kcal to 120 µg RAE/100 kcal, with only preformed vitamin A counting toward those bounds. Vitamin D would be expressed in micrograms, with the proposed minimum rising from 40 IU (1 µg)/100 kcal to 2 µg/100 kcal (80 IU/100 kcal) and the proposed maximum from 100 IU (2.5 µg)/100 kcal to 3 µg/100 kcal (120 IU/100 kcal). The FDA proposes to retain current minima and maxima for chloride at 55 mg/100 kcal and 150 mg/100 kcal, potassium at 80 mg/100 kcal and 200 mg/100 kcal, selenium at 2 µg/100 kcal and 7 µg/100 kcal, and sodium at 20 mg/100 kcal and 60 mg/100 kcal. Labeling would be updated to match the proposed nutrient changes.

The proposal also seeks comment on possible requirements for nutrients not now required in infant formula but commonly added by manufacturers, including arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine. The FDA says there is evidence that these nutrients contribute to neurodevelopmental health in infancy. With this notice of proposed rulemaking, the FDA is not proposing to remove or add new nutrients to the required list. The agency states that the proposed changes are not driven by safety concerns but are a proactive effort to align regulatory standards with current scientific understanding, and that infant formulas now marketed in the United States remain safe for babies. If finalized, the rule would apply to products that meet the statutory definition of infant formula in section 201(z) of the FD&C Act, except for certain exempt infant formula. The proposed nutrient changes would not have an immediate effect on the WIC program. The FDA intends that a comprehensive final rule would become effective 60 days after Federal Register publication, with a compliance date three years from that effective date for industry to reformulate and relabel. In Phase 3, the FDA plans to examine protein, fat, linoleic acid, iron, copper, zinc, calcium, phosphorus, magnesium, and vitamin K, and to evaluate potential additional nutrients including DHA, ARA, alpha-linolenic acid, and L-carnitine, as well as carbohydrate sources.