Federal · FDA proposed rule, FR Doc. 2026-22273

FDA proposes new nutrient levels for infant formula: more vitamin D and iodine, less vitamin A, and a first-ever limit on manganese

Proposed rule filed Oct. 29, 2026 · Scheduled for Nov. 2, 2026 Federal Register · Comments for 120 days

Published October 30, 2026 · Last updated October 30, 2026

This explainer does not take a side. It describes what the proposed rule says, using the document filed with the Federal Register. It is not medical advice; talk with your child’s doctor about feeding questions.

What it does

Infant formula sold in the U.S. must contain 30 required nutrients. FDA’s table at 21 CFR 107.100 sets a minimum level for each one and a maximum level for 10 of them. FDA says this proposal, part of the HHS/FDA “Operation Stork Speed” initiative announced March 18, 2025, is “the first comprehensive update and review of infant formula nutrients by the FDA since 1998.” It reviews 8 of the 30 nutrients. (Proposed rule, Executive Summary and Background)

If finalized, the proposal would change four nutrients (all amounts are per 100 calories of formula) (Proposed rule, Summary of the Major Provisions):

• Vitamin D: minimum up from 40 IU (1 microgram) to 80 IU (2 micrograms); maximum up from 100 IU (2.5 micrograms) to 120 IU (3 micrograms).
• Iodine: minimum up from 5 to 15 micrograms; maximum down from 75 to 50 micrograms.
• Vitamin A: minimum down from 250 IU (75 micrograms RAE) to 233 IU (70 micrograms RAE); maximum down from 750 IU (225 micrograms RAE) to 400 IU (120 micrograms RAE). Only preformed vitamin A would count toward these levels; beta-carotene would no longer count.
• Manganese: minimum down from 5 to 1 microgram, and a new maximum of 50 micrograms (there is no maximum today).

FDA reviewed four more nutrients, chloride, selenium, potassium and sodium, and concluded their current levels “remain appropriate.” (Proposed rule, Executive Summary)

Label changes

The required nutrition label would list vitamin A in micrograms RAE (retinol activity equivalents) instead of IU, and vitamin D in micrograms instead of IU. Companies could also show the IU amounts in parentheses right after. (Proposed rule, Executive Summary; proposed 21 CFR 107.10)

Why FDA says it is doing this

• FDA says the goal is to make sure 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.” (Proposed rule, Purpose)
• The law (as amended in 2022) tells FDA to review the nutrient table “every 4 years as appropriate,” considering new science and international standards. FDA says that for each nutrient it reviewed the science since the 1998 review, reference values from major expert bodies, human milk composition data and international standards. It issued a request for information on May 14, 2025 as a first step. (Proposed rule, Legal Authority and Approach)
• FDA says vitamin D is needed for calcium absorption and bone growth and prevents rickets, and it lists lower risk of too little iodine and too much vitamin A or manganese as other expected benefits. (Proposed rule, Costs and Benefits)

Who it affects

• Infant formula makers, who would have to reformulate and relabel products and notify FDA before making changed formulas. (Proposed rule, Costs and Benefits)
• Families who use formula for babies up to 12 months old. The rule covers products that meet the legal definition of “infant formula.” (Proposed rule, Scope)

What it means for you

• Nothing changes yet. This is a proposal. Formula on the shelf today still has to meet the current requirements.
• Changes would come slowly. FDA plans more proposed rules on the other nutrients, “followed by one final rule covering all infant formula nutrient requirement changes.” It proposes that the final rule take effect 60 days after it is published, with a compliance date 3 years after that. (Proposed rule, Executive Summary and Proposed Effective/Compliance Dates)
• Labels may look different later. If finalized, expect vitamin A and D amounts in micrograms, possibly with IU in parentheses.

Costs and benefits (FDA estimates)

FDA’s primary estimate is about $80.9 million a year in benefits and $17.6 million a year in costs over 10 years (7 percent discount rate), with a range of $18.8 million to $171.7 million in benefits and $8.4 million to $31.7 million in costs. The costs are mainly relabeling, reformulation and paperwork for formula makers. (Proposed rule, Costs and Benefits)

How to comment

Comments go to Docket No. FDA-2026-N-10832 at regulations.gov (until 11:59 p.m. Eastern Time on the deadline), or by mail to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The deadline is 120 days after publication. With publication scheduled for November 2, 2026, that would be March 2, 2027. Comments are posted publicly, so leave out personal medical information. (Proposed rule, Dates and Addresses)

Current status

Filed for public inspection October 29, 2026 and scheduled for publication November 2, 2026 (FR Doc. 2026-22273; RIN 0910-AJ34). It is a proposed rule, not a final rule. FDA says it intends to have an outside peer review of the key science before any final rule. (Proposed rule)

What happens next

FDA will review comments, issue proposals on the remaining nutrients and then publish a single final rule. If the label changes are finalized, FDA says it will allow objections and requests for a formal hearing. (Proposed rule, Executive Summary and Legal Authority)

Sources

• Federal Register: “Infant Formula Nutrient Requirements,” FDA proposed rule, FR Doc. 2026-22273 (on public inspection Oct. 29, 2026; scheduled for publication Nov. 2, 2026)
• Public inspection PDF of the proposed rule (155 pages)
• FDA: Operation Stork Speed
• eCFR: 21 CFR part 107, Infant Formula (current rules)

Every statement above is drawn from the official source text linked here; section references are shown in grey. This is a plain-English summary, not legal advice. Spot an error? Tell us.