The U.S. Food and Drug Administration (FDA) has published a proposed rule on infant formula nutrient requirements that would update or reaffirm specifications for eight of the 30 nutrients required in infant formula sold in the United States. The proposal would revise minimum and maximum levels for iodine, manganese, vitamin A, and vitamin D, while retaining current levels for chloride, potassium, selenium, and sodium.
The proposal is the first of three phases in a comprehensive review of infant formula nutrient requirements, and it marks the start of a reformulation and relabelling cycle that will eventually cover every required nutrient. The FDA is accepting public comments for 120 days from the date the rule is published in the Federal Register. It is also asking for input on nutrients that are not currently required but are commonly added by manufacturers, including arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine.
What The Proposed Rule Would Change
Under the proposal, four nutrients would see revised limits and two would move to new units of measure. For the other four, the FDA concluded after its assessment that current ranges remain appropriate. All levels below are expressed per 100 kcal.
- Iodine: the minimum would rise from 5 µg to 15 µg, and the maximum would fall from 75 µg to 50 µg.
- Manganese: the minimum would drop from 5 µg to 1 µg, and a new maximum of 50 µg would be established.
- Vitamin A: the unit would change from International Units (IU) to µg retinol activity equivalents (RAE), with the minimum lowered to 70 µg RAE and the maximum lowered to 120 µg RAE.
- Vitamin D: the unit would change from IU to µg, with the minimum raised to 2 µg and the maximum raised to 3 µg.
- Chloride, potassium, selenium, and sodium: current minimum and maximum levels would be retained.
Vitamin A Forms Would Be Narrowed
The vitamin A change goes further than new numbers. Only preformed vitamin A would count toward the minimum and maximum content, which means beta-carotene would no longer contribute to meeting the specification. For formulas that currently rely on beta-carotene to reach vitamin A targets, this may require changes to the premix rather than a simple adjustment in quantity.
In addition, the proposal would update infant formula labelling requirements to reflect the new units and levels, so packaging changes would accompany any reformulation.
A Three-Phase Review Leading To One Final Rule
This proposal reflects only the first phase of the FDA’s review. Phase 2 covers vitamin E, the B vitamins, folic acid, biotin, vitamin C, choline, and inositol, and that evidence review is currently underway. Phase 3 addresses protein, fat, linoleic acid, iron, copper, zinc, calcium, phosphorus, magnesium, and vitamin K, along with potential new requirements for DHA, ARA, alpha-linolenic acid, L-carnitine, and carbohydrate sources.
Because the Phase 3 evidence is more complex, the FDA has engaged an external organization to conduct that review under FDA scientific oversight. The agency expects to publish two more proposed rules, one after each remaining phase, and then consolidate every change into a single comprehensive final rule. The review is a priority under Operation Stork Speed and is the most thorough evaluation of infant formula nutrients since 1998. The FDA will also submit the review to independent peer review under the Information Quality Act.
Compliance Timeline And Scope
Once published, the consolidated final rule would take effect 60 days after its Federal Register publication. The FDA has proposed a compliance date of three years from that effective date, giving manufacturers time to reformulate and relabel products under 21 CFR 106 and 21 CFR 107.
The rule would apply to products that meet the definition of infant formula in section 201(z) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), with the exception of certain exempt infant formulas. Notably, the FDA states that the proposed changes are not driven by safety concerns and that formulas currently on the U.S. market remain safe. Instead, the agency describes the update as an effort to align standards with current science on human milk composition and infant nutritional needs.
What This Means For Your Business
No new obligations apply yet. Since the FDA intends to issue a single final rule after all three phases, manufacturers will not face rolling compliance deadlines as each proposal is published. Even so, the Phase 1 figures show the direction of travel, and they give formulation and regulatory teams an early basis for planning.
A practical starting point is a gap assessment of current formulations against the proposed iodine, manganese, vitamin A, and vitamin D ranges. Products that count beta-carotene toward vitamin A content deserve particular attention, as do premix specifications and supplier agreements that may need revision. Labelling teams can also begin mapping where IU values appear today, since the proposal would move vitamin A and vitamin D to microgram-based units.
The comment period is equally relevant. Companies with data on ARA, DHA, or L-carnitine, or with concerns about the feasibility of the proposed ranges, have a defined window to put that evidence on the record. Quality Smart Solutions advises manufacturers, including Canadian companies supplying the U.S. market, to treat this proposal as the first input into a multi-year product plan rather than a one-time update.
Frequently Asked Questions
Do Manufacturers Need To Reformulate Infant Formula Now?
Many teams assume each proposed rule starts its own clock, but that is not how the FDA has structured this review. Changes from all three phases will be consolidated into one final rule, which would take effect 60 days after publication. The proposed three-year compliance period would then run from that effective date, not from the date of this proposal.
Will DHA, ARA, And L-Carnitine Become Required Nutrients?
The request for input on these nutrients has prompted questions about whether they will be mandated. This proposal does not add or remove any required nutrients. The FDA has noted evidence that these nutrients contribute to neurodevelopmental health in infancy, and they will be evaluated in Phase 3, which may lead to a future proposed rule.
How Can Companies Submit Comments On The Proposed Rule?
Because the comment window is tied to Federal Register publication rather than the FDA announcement, the deadline can be easy to misjudge. Comments are accepted for 120 days from the date of Federal Register publication under Docket No. FDA-2026-N-10832. The Federal Register notice sets out submission instructions, and the full text of the rule is available in the docket.
Key Takeaways
- The FDA has proposed revised levels for iodine, manganese, vitamin A, and vitamin D, and retained levels for chloride, potassium, selenium, and sodium.
- Only preformed vitamin A would count toward vitamin A content, and vitamin A and vitamin D would move to microgram-based units.
- Two more proposed rules are expected before one consolidated final rule.
- The proposed compliance date is three years after the final rule takes effect.
- Comments are open for 120 days from Federal Register publication.
Conclusion
This proposal is the first concrete signal of how infant formula nutrient requirements in the United States are likely to change over the coming years. Manufacturers that assess formulations, review vitamin A sources, and consider submitting comments now will be better placed when the final rule arrives.
