Twenty-Eight Years of We'll Get to It: FDA Finally Rewrites Baby Formula Rules
Desk: Political & Government, Public Policy & Regulatory
By Dakota Jones
Here’s the headline: on October 29, 2026, the FDA published a proposed rule to update or reaffirm specifications for eight of the 30 nutrients required in infant formula sold in the United States. It is the first phase of a comprehensive review, and the most thorough evaluation of infant formula nutrient requirements since 1998.
That’s twenty-eight years between comprehensive reviews. The law directs the FDA to review these requirements every four years, “as appropriate.” The words “as appropriate” have apparently had a very long shift.
The timing is hard to ignore. The last comprehensive review was in 1998, and the intervening years included the 2022 infant formula shortage. Parents had a supply crisis to navigate while the nutrient rulebook remained due for a major update. The FDA is now moving through a science review in phases. Late is not the same as complete, but at least the process is underway.
What the FDA proposes to change
The proposal, Docket No. FDA-2026-N-10832, covers eight nutrients. Its proposed specifications are measured per 100 kilocalories of formula.
- Iodine: Increase the minimum from 5 µg to 15 µg and decrease the maximum from 75 µg to 50 µg.
- Manganese: Decrease the minimum from 5 µg to 1 µg and establish a new maximum of 50 µg.
- Vitamin A: Change the unit from International Units (IU) to micrograms of retinol activity equivalents (µg RAE). Decrease the minimum from 250 IU (75 µg RAE) to 70 µg RAE and the maximum from 750 IU (225 µg RAE) to 120 µg RAE. The proposal would count only preformed vitamin A toward the minimum and maximum; beta-carotene would no longer count.
- Vitamin D: Change the unit from IU to micrograms. Increase the minimum from 40 IU (1 µg) to 2 µg (80 IU) and the maximum from 100 IU (2.5 µg) to 3 µg (120 IU).
Four other nutrients would retain their current specifications. The FDA determined these levels are appropriate:
- Chloride: Minimum 55 mg; maximum 150 mg.
- Potassium: Minimum 80 mg; maximum 200 mg.
- Selenium: Minimum 2 µg; maximum 7 µg.
- Sodium: Minimum 20 mg; maximum 60 mg.
The FDA also proposes updating infant formula labeling requirements to match the nutrient changes. This is a proposal, not a final rule, so the numbers are under review, not instructions for families to change formula.
What this means for families
The FDA says the proposal is not driven by safety concerns. Formulas currently on the U.S. market remain safe for babies. The agency describes the review as a proactive effort to align regulatory standards with current science, including updated understanding of human milk composition.
That distinction deserves to be stated plainly: a proposed change to nutrient specifications does not mean today’s formula is unsafe. It means the agency is considering whether its standards should reflect the evidence now available.
The review is a priority under Operation Stork Speed. The FDA also considered comments submitted during its 2025 Request for Information. And now the public has an opportunity to comment on the proposed rule itself. Because, yes, public input is part of the regulatory process, even if it does not come with the instant gratification of a revised rulebook.
Three phases, one eventual rule
The FDA is organizing its comprehensive review in three phases, based on the evidence available for different nutrient groups.
- Phase 1, the current proposal: Iodine, manganese, selenium, sodium, potassium, chloride, vitamin A and vitamin D.
- Phase 2. Evidence review underway: Vitamin E, thiamine, riboflavin, niacin, pantothenic acid, vitamins B6 and B12, folic acid, biotin, vitamin C, choline and inositol.
- Phase 3, evidence review by an external organization: Protein, fat, linoleic acid, iron, copper, zinc, calcium, phosphorus, magnesium and vitamin K. This phase also covers potential additional nutrients (DHA, ARA, alpha-linolenic acid and L-carnitine) and carbohydrate sources.
The FDA is requesting input on potential requirements for nutrients not currently required but commonly added by manufacturers, including DHA, ARA (arachidonic acid) and L-carnitine. The agency says there is evidence these nutrients contribute to neurodevelopmental health in infancy. To be clear, that is a request for input; this proposal does not make them mandatory.
The timeline: comments, review and implementation
Public comments are accepted for 120 days from Federal Register publication. The FDA’s proposed-rule page links to the Federal Register notice and information on submitting comments under docket FDA-2026-N-10832. Anyone with relevant evidence or practical concerns can review the proposal and participate.
The FDA intends to consolidate all final changes from the comprehensive review into a single final rule. If finalized, that rule would become effective 60 days after publication in the Federal Register. The proposed compliance date is three years from the effective date, giving industry time to reformulate and relabel products.
The comprehensive nutrient review will also be submitted for independent peer review under the Information Quality Act. The proposed changes would have no immediate impact on the WIC program; the FDA says it will work with USDA on considerations for the final rule.
So this is a multi-step process: public comments, additional evidence reviews, peer review, and then a consolidated final rule. A phased timeline may help the FDA work through complex evidence. It also means the comprehensive update is not arriving all at once.
FAQ
Does the proposal mean current infant formula is unsafe?
No. The FDA says formulas currently on the market remain safe for babies. It says the proposed changes are not driven by safety concerns.
Are DHA, ARA and L-carnitine becoming required?
Not under this proposal. The FDA is seeking public input on potential requirements as the broader review continues.
When would manufacturers need to comply?
The proposed compliance date is three years from the final rule’s effective date. The final rule would take effect 60 days after Federal Register publication.
Can the public comment?
Yes. The comment period is 120 days from Federal Register publication. See the FDA’s proposed-rule page for docket details and comment information.
Final Thoughts
The FDA has begun revisiting infant formula nutrient standards after a twenty-eight-year gap, despite a law directing reviews every four years “as appropriate.” The first phase proposes changes to four nutrient specifications, retains four others, and opens questions about additional nutrients to public input.
The next steps matter as much as the announcement: complete the remaining evidence reviews, consider public comments, and deliver the promised comprehensive final rule. For families, the immediate message is clear: the FDA says current formula remains safe. For everyone following the policy, the practical move is to read the proposal, check the timeline and keep asking for a review process that moves forward.
Sources
- U.S. Food and Drug Administration,"Infant Formula Notice of Proposed Rulemaking: Infant Formula Nutrient Requirements", https://www.fda.gov/food/infant-formula-homepage/infant-formula-notice-proposed-rulemaking-infant-formula-nutrient-requirements
- NBC News ("FDA plans to update nutrition rules for infant formula" (Aria Bendix and Erika Edwards, Oct. 29, 2026)) https://www.nbcnews.com/health/kids-health/fda-infant-formula-update-nutrition-rules-rcna606315