Food and Drug Administration proposes first infant formula nutrient overhaul since 1998

The Food and Drug Administration proposed on Monday to rewrite the nutrient standards for infant formula for the first time since 1998, capping manganese and resetting the required levels of iodine, vitamin A and vitamin D. The proposal, published in the Federal Register of November 2, 2026 (Vol. 91, No. 210, Proposed Rules, p. 69040) under Docket No. FDA-2026-N-10832 and RIN 0910-AJ34, would amend 21 CFR 107.100 and the labeling rules in 21 CFR 107.10. Written or electronic comments must be filed by March 2, 2027.

The rule rests on section 412(i) of the Federal Food, Drug, and Cosmetic Act, which the Infant Formula Act of 1980 added and which lists the nutrients infant formula must contain with minimum and, where applicable, maximum levels, and which was amended by the Food and Drug Omnibus Reform Act of 2022 to require review of that table every four years. The table currently specifies 30 required nutrients, with maximums fixed for 10 of them; the last comprehensive review was the 1998 report by the Life Sciences Research Office, and the last amendment came in 2015, when the agency added selenium (80 FR 35834, June 23, 2015). The FDA frames this proposal as part of the phased review announced with the Department of Health and Human Services in March 2025 under Operation Stork Speed, and it assesses 8 of the 30 nutrients. Products covered are those meeting the statutory definition of infant formula, a food for infants not more than 12 months of age.

A first cap on manganese

The headline change is manganese, currently subject only to a minimum of 5 micrograms per 100 kilocalories and no ceiling. The FDA proposes to cut that minimum to 1 microgram and to establish a maximum of 50 micrograms per 100 kilocalories, citing manganese accumulation in the developing brain and the fact that soy protein-based formulas carry far higher levels (roughly 200 to 300 micrograms per litre) than cow milk-based products (roughly 30 to 50). The agency acknowledges the proposed maximum may be the lowest technologically achievable level for soy protein-based formulas and asks for data on whether lower-manganese soy protein sources exist.

Iodine, vitamin A and vitamin D

The remaining revisions move in both directions, tightening upper limits and raising or lowering minimums:

• Iodine: minimum raised from 5 to 15 micrograms per 100 kilocalories; maximum lowered from 75 to 50 micrograms.
• Vitamin A: minimum cut from 250 international units (75 micrograms RAE) to 70 micrograms RAE; maximum cut from 750 international units (225 micrograms RAE) to 120 micrograms RAE; only preformed vitamin A, not beta-carotene, would satisfy the requirement.
• Vitamin D: minimum raised from 40 international units (1 microgram) to 2 micrograms (80 international units); maximum raised from 100 international units (2.5 micrograms) to 3 micrograms (120 international units).
• Labeling: vitamin A would be declared in micrograms of retinol activity equivalents and vitamin D in micrograms, with optional international-unit values in parentheses.

What stays, and what the FDA still wants to know

The agency concluded that current requirements for chloride, selenium, potassium and sodium remain appropriate and proposes no change there, noting that the established minimums and maximums still sit within the range used by Codex Alimentarius, the European Union, Canada, Australia and New Zealand. At the same time it opens a series of parallel questions: whether to require docosahexaenoic acid and arachidonic acid and at what ratios, whether alpha-linolenic acid should become a required nutrient, whether iron levels should differ for infants aged 0 to 6 months and 7 to 12 months, whether L-carnitine should be mandatory, and how variability in tap and bottled water affects maximum standards such as chloride. It also intends to commission an external peer review of the influential scientific information behind any final rule.

Costs, benefits and the compliance clock

Any final rule would take effect 60 days after publication, with a proposed compliance date of three years after that effective date. The agency estimates annualized benefits over 10 years of $18.8 million to $171.7 million, a primary estimate of $80.9 million at a 7 percent discount rate, driven mainly by avoided health-care costs from vitamin D deficiency-induced late-onset hypocalcemia, and annualized costs of $8.4 million to $31.7 million, a primary estimate of $17.6 million at 7 percent, from reformulation, relabeling and notification submissions. Benefits would begin accruing in 2031, and the agency concedes the rule may have a significant economic impact on a substantial number of small entities.

For parents, the practical effect is a labeling change and, eventually, formula formulated to narrower nutrient windows; for manufacturers, it is a reformulation and relabeling cycle with a three-year runway. The manganese ceiling is the provision most likely to draw industry comment, since it lands on soy protein-based and amino acid-based products that have no easy substitute for the mineral.

Source: Federal Register, Vol. 91, No. 210, November 2, 2026, Proposed Rules, p. 69040 (official reference: FR Doc. 2026-22273; Docket No. FDA-2026-N-10832).