The U.S. Food and Drug Administration (FDA) has proposed new nutritional requirements for infant formula, potentially requiring manufacturers to reformulate products and update their labeling. Published in the Federal Register on November 2, 2026, the proposal would change the permitted levels of four nutrients and introduce new requirements for how certain vitamins appear on product labels.
The proposed rule is part of the FDA’s Operation Stork Speed initiative and marks the agency’s first comprehensive review of infant formula nutrient requirements since 1998. Although the changes are not yet mandatory, manufacturers may face additional testing, FDA notification requirements, and production costs if the agency adopts the proposal. The FDA has emphasized that currently marketed infant formulas remain safe and that the review is intended to align nutritional standards with current scientific evidence.
FDA Targets Four Nutrients in Infant Formula
The FDA’s proposed rule, Infant Formula Nutrient Requirements, reviews eight of the 30 nutrients currently required in infant formula. The agency proposes revising the minimum or maximum levels of iodine, manganese, vitamin A, and vitamin D while retaining existing requirements for chloride, selenium, potassium, and sodium.
The proposed changes include:
- Iodine: Increasing the minimum from 5 to 15 micrograms per 100 calories while reducing the maximum from 75 to 50 micrograms.
- Manganese: Reducing the minimum from 5 to 1 microgram per 100 calories and establishing a new maximum of 50 micrograms.
- Vitamin A: Reducing the permitted range from 75–225 to 70–120 micrograms of retinol activity equivalents per 100 calories.
- Vitamin D: Increasing the permitted range from 1–2.5 to 2–3 micrograms per 100 calories.
The vitamin A and manganese changes could be particularly consequential for manufacturers. The FDA proposes allowing only preformed vitamin A to count toward the required vitamin A levels, rather than permitting manufacturers to count beta-carotene. Manufacturers could still use beta-carotene in permitted circumstances, but it would no longer contribute to meeting the mandatory vitamin A specifications.
The proposed manganese maximum would also introduce a restriction that does not currently exist under federal infant formula nutrient standards. This could affect products containing ingredients with naturally occurring manganese, including certain soy-based formulations. Manufacturers would need to evaluate total manganese content rather than relying exclusively on the amounts intentionally added during production.
Infant Formula Reformulation Could Trigger FDA Notification Requirements
Changes to infant formula composition can carry obligations beyond adjusting nutrient concentrations. Under the Federal Food, Drug, and Cosmetic Act and 21 CFR Parts 106 and 107, manufacturers must meet specific requirements for nutrient content, production controls, quality testing, and submissions to the FDA.
One issue is whether reformulating an existing product would qualify as a major change under federal law. A major change generally involves a modification to ingredients or processing that could materially affect nutrient levels, nutrient availability, or the formula’s composition.
When a reformulation qualifies as a major change, the product may be treated as a new infant formula for FDA notification purposes. Manufacturers generally must submit information to the agency at least 90 days before marketing a new infant formula, including details of its formulation and assurances concerning nutritional adequacy.
Not every adjustment to a vitamin or mineral concentration automatically triggers this requirement. The FDA’s existing rules require manufacturers to assess the nature and potential effects of each formulation change. This distinction could affect production schedules for companies preparing to meet revised nutrient limits, particularly those operating multiple formulations or relying on contract manufacturers.
The proposal would also modify labeling requirements under 21 CFR § 107.10. Manufacturers would need to declare vitamin A in micrograms of retinol activity equivalents and vitamin D in micrograms, replacing the current mandatory use of International Units. International Units could still appear voluntarily in parentheses following the required measurements.
These changes could extend to packaging approvals and product representations. A manufacturer that adjusts vitamin concentrations would need to confirm that its nutrient declarations accurately reflect the finished product. Any advertising suggesting particular nutritional or developmental benefits would still require appropriate scientific support, regardless of whether the formula meets FDA nutrient specifications.
Commercial agreements may introduce another complication. A brand owner working with a third-party manufacturer may need to determine who is responsible for reformulation expenses, additional testing, updated labels, and required FDA submissions. Existing manufacturing agreements may not expressly allocate costs arising from revised federal nutrient standards.
FDA’s Three-Phase Review Could Bring Further Formula Changes
The November proposal represents only the first phase of the FDA’s review. The agency plans to examine the remaining required nutrients through two additional proposed rules, including protein, fats, iron, and several vitamins. The review comes alongside other FDA initiatives addressing food composition and labeling, including its separate examination of gluten labeling and cross-contact controls.
The FDA is also considering whether ingredients commonly added voluntarily, such as docosahexaenoic acid (DHA), arachidonic acid (ARA), and L-carnitine, should become mandatory. Such changes could have consequences for ingredient sourcing, product development, and nutritional claims used to distinguish competing infant formula products.
Rather than requiring manufacturers to comply with each phase separately, the FDA intends to consolidate the resulting amendments into one final rule. Under the current proposal, that rule would become effective 60 days after publication, with manufacturers receiving three years from the effective date to complete required reformulation and relabeling.
The proposed transition period acknowledges the complexity of changing infant formula production. However, the three-year period would begin only after the comprehensive final rule takes effect, and the FDA has not announced when that final rule will be issued.
Strategic By Design: The Juris Law Group, P.C. Perspective on Food and Beverage Law
For infant formula manufacturers, the proposed changes present a product development issue with direct legal consequences. Our food law attorneys assess how formulation changes interact with FDA notification requirements, labeling accuracy, manufacturing agreements, and product representations. The proposed vitamin A restrictions, for example, could require manufacturers to reconsider both their ingredient sources and the supporting documentation used to establish nutritional adequacy.
The distinction between a mandatory reformulation and a major formulation change deserves particular attention. A manufacturer may have sufficient time to implement revised nutrient limits under the proposed transition period but still need to account for existing FDA notification procedures before introducing a modified product. Contractual approval rights, testing responsibilities, and ingredient supplier obligations could further affect how quickly a manufacturer can complete the transition.
The FDA is accepting public comments through March 2, 2027, under Docket No. FDA-2026-N-10832. Manufacturers can use this period to address technical concerns, the feasibility of proposed nutrient ranges, and the costs associated with changing established formulations.
The agency’s next two proposed rules will determine how extensive the eventual revisions become. For manufacturers, the developing standards could affect future product launches and reformulation decisions well before the final compliance deadline. The scope of those obligations will depend on the final nutrient specifications, the treatment of additional ingredients, and the implementation schedule adopted by the FDA.
Common Legal Inquiries
1. Are the FDA’s proposed infant formula nutrient requirements mandatory in 2026?
No. The FDA published the proposed rule on November 2, 2026, but the revisions have not been finalized. Existing federal infant formula requirements remain in effect. The FDA is accepting comments through March 2, 2027, and intends to issue a comprehensive final rule after completing its remaining nutrient reviews.
2. Would infant formula manufacturers need to notify the FDA before reformulating their products?
Possibly. Under existing FDA requirements, a major change in an infant formula’s composition or processing can trigger a new infant formula submission at least 90 days before marketing. Whether a particular nutrient adjustment qualifies depends on the nature of the change and its potential effect on the product.
3. How much time would infant formula manufacturers have to comply with the new FDA rules?
The FDA proposes a three-year compliance period beginning when the comprehensive final rule becomes effective. The agency proposes that the final rule take effect 60 days after publication. These dates are not yet binding, and the final implementation schedule may change following public comments and additional scientific reviews.
