On November 2, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule that would significantly revise the nutrient composition and labeling requirements for infant formula marketed in the United States. This proposed rule represents the first phase of FDA’s comprehensive review of infant formula nutrient standards under Operation Stork Speed, an initiative launched in March 2025 to strengthen infant formula safety, nutritional adequacy, and supply chain resilience.
The proposed rule evaluates eight of the 30 nutrients currently required in infant formula and would revise the minimum and/or maximum permitted levels for four of these nutrients: iodine, vitamin A, vitamin D, and manganese. FDA would retain the existing requirements for chloride, selenium, potassium, and sodium. The proposed rule would also revise labeling requirements for vitamins A and D and limit which forms of vitamin A may be counted toward compliance with the nutrient specifications. FDA intends to address the remaining mandatory nutrients through subsequent proposed rules, followed by a single comprehensive final rule.
If finalized, the changes could require manufacturers to reformulate products, adjust ingredient sourcing and manufacturing processes, and update labeling. Retailers and distributors could also face implications for product availability, inventory transitions, and product information accuracy. FDA proposes a three-year compliance period following the effective date of the comprehensive final rule. Stakeholders have an opportunity to inform the final requirements by submitting comments on the proposed nutrient specifications, including their scientific basis and potential manufacturing and operational implications, by March 2, 2027.
FDA’s current nutrient requirements for infant formula are established under 21 CFR § 107.100. The proposed rule would revise four nutrient specifications, based on the agency’s assessment of updated scientific evidence concerning infant nutritional needs and the potential risks of inadequate or excessive nutrient intake.
The table below summarizes the proposed changes. All quantities are expressed per 100 kilocalories (kcal) of infant formula.
Nutrient | Current Requirements (Min. to Max.) | Proposed Requirements (Min. to Max.) | Key Changes and Rationale |
Iodine | 5–75 µg | 15–50 µg | Triples the minimum and reduces the maximum by one-third to support adequate thyroid function and neurological development while limiting excessive exposure. |
Vitamin A | 75–225 µg RAE | 70–120 µg RAE | Slightly reduces the minimum and lowers the maximum by approximately 47% to address risks associated with excessive preformed vitamin A intake. Only preformed vitamin A would count toward compliance. |
Vitamin D | 1–2.5 µg | 2–3 µg | Doubles the minimum to support adequate intake and reduce deficiency-related risks, while increasing the maximum by 20% to accommodate nutrient losses during processing and storage. |
Manganese | 5 µg; no maximum | 1–50 µg | Reduces the minimum by 80% and establishes the first maximum limit to address concerns about excessive manganese exposure and potential adverse neurodevelopmental effects. |
RAE = retinol activity equivalents. Current vitamin A and vitamin D values are expressed in the proposed units for comparison.
Two aspects of these proposed changes could have particular implications for manufacturers. First, FDA would prohibit manufacturers from counting beta-carotene toward the required vitamin A levels, although beta-carotene could continue to be used as an ingredient. Second, the proposed manganese maximum could create formulation challenges for soy protein-based infant formulas, which naturally contain higher manganese concentrations. FDA specifically seeks comments on the technical feasibility of achieving the proposed limit.
FDA also evaluated chloride, selenium, potassium, and sodium and concluded that their existing minimum and maximum requirements remain appropriate. The proposed rule would therefore leave specifications for those nutrients unchanged.
The proposed rule would amend 21 CFR § 107.10 to require manufacturers to declare vitamin A content in micrograms RAE and vitamin D content in micrograms, rather than IU. Manufacturers could continue to provide IU equivalents voluntarily in parentheses following the required declarations.
These changes would apply even to products that do not require reformulation. FDA estimates that approximately 326 infant formula product Universal Product Codes (UPCs) would be subject to relabeling.
FDA proposes that the comprehensive final rule become effective 60 days after publication, with manufacturers required to comply three years after the effective date. The agency intends to consolidate changes arising from all three phases of its nutrient review into that final rule, rather than requiring manufacturers to implement each phase separately.
At this stage, infant formula manufacturers and other supply chain participants should consider the following:
FDA’s preliminary economic analysis estimates annualized compliance costs of approximately $17.6 million over 10 years, using a 7% discount rate, primarily attributable to reformulation, relabeling, and associated regulatory submissions. The agency acknowledges that the proposed rule could have significant economic implications for smaller manufacturers.
The current proposed rule is the first of three planned rulemakings under FDA’s comprehensive infant formula nutrient review. Subsequent phases will evaluate the remaining required nutrients and whether additional nutrients, including docosahexaenoic acid (DHA), arachidonic acid (ARA), alpha-linolenic acid (ALA), and L-carnitine, should become mandatory. FDA is also seeking input on whether existing iron requirements should be revised, including whether different specifications may be appropriate for particular infant populations.
These additional reviews could result in further changes to infant formula composition standards beyond those addressed in the current proposed rule. Companies should therefore consider the potential cumulative effects of FDA’s broader review when evaluating formulation strategies and longer-term compliance planning.
Comments on the proposed rule must be submitted by March 2, 2027 under Docket No. FDA-2026-N-10832.
MoFo’s Food Regulatory team continues to monitor FDA’s infant formula initiatives and is available to assist companies in assessing potential compliance implications, evaluating reformulation and labeling considerations, and preparing comments on the proposed requirements.