FDA Proposes First Updates to Infant Formula Nutrient Requirements in Over 30 Years

On Monday, FDA published a proposed rule that would amend the nutrient requirements for infant formula under 21 CFR Parts 107 and 184. The proposed rule represents the first update to FDA's infant formula nutrient standards in 30 years and is a part of the Trump Administration’s Operation Stork Speed initiative and one of FDA’s Human Foods Program’s priority deliverables for 2026. Comments are due by March 2, 2027.

The proposal is the first of three proposed rules that FDA intends to issue as part of a phased review of the thirty nutrients currently required in infant formula that is marketed in the United States. This initial proposal is the result of FDA’s assessment of eight of the thirty required nutrients. FDA intends to combine the final changes from all three proposed rules into a single, comprehensive final rule.

This proposed rule results from FDA’s assessment of eight nutrients: iodine, manganese, vitamin A, vitamin D, chloride, potassium, selenium, and sodium. In developing the proposed rule, FDA evaluated nutrient reference levels, human milk composition, international infant formula standards, clinical literature, and comments submitted in response to its 2025 Request for Information on Infant Formula Nutrient Requirements.

As outlined in more detail below, FDA proposes to update the requirements for four nutrients (iodine, manganese, vitamin A, and vitamin D) and to reaffirm the existing requirements, without change, for four others (chloride, potassium, selenium, and sodium). The proposed rule would also change the units of measure for vitamin A and vitamin D and change the permitted source for meeting the vitamin A requirement. In addition, FDA is requesting public input on potential requirements for ingredients that are not currently required in infant formula but that manufacturers commonly add for their nutritional value, including arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine.

• Iodine. FDA proposes to increase the required minimum level from five μg per 100 kilocalories (kcal) to fifteen μg/100 kcal, and to decrease the maximum level from 75 μg/100 kcal to 50 μg/100 kcal.
• Vitamin A. FDA proposes to:
  • Decrease the required minimum level from 250 IU/100 kcal (75 μg RAE/100 kcal) to 70 μg RAE/100 kcal (233 IU/100 kcal);
  • Decrease the maximum level from 750 IU/100 kcal (225 μg RAE/100 kcal) to 120 μg RAE/100 kcal (400 IU/100 kcal); and
  • Limit the permitted forms of vitamin A to preformed vitamin A only, such that beta-carotene would no longer count toward the vitamin A requirement.
  • Change the unit of measure from IU to μg RAE (1 IU retinol = 0.3 μg RAE).
• Vitamin D. FDA proposes to:
  • Increase the required minimum level from 40 IU/100 kcal (1 μg/100 kcal) to two μg/100 kcal (80 IU/100 kcal); and
  • Increase the maximum level from 100 IU/100 kcal (2.5 μg/100 kcal) to three μg/100 kcal (120 IU/100 kcal).
  • Change the unit of measure from IU to μg (1 IU = 0.025 μg).
• Manganese. FDA proposes to decrease the required minimum level from five μg/100 kcal to one μg/100 kcal and to establish, for the first time, a maximum level of 50 μg/100 kcal.

Requests for Comment

In addition to the proposed changes described above, FDA is seeking comments on several related issues:

• Additional Nutrient Requirements. FDA requests comments on whether to add requirements for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), arachidonic acid (ARA), and L-carnitine. In announcing the proposed rule, FDA stated that there is evidence to support that nutrients such as ARA, DHA, and L-carnitine contribute to neurodevelopmental health in infancy.
• Iron. FDA requests comments on whether iron level requirements should be changed or should differ for specific populations (e.g., infants 0-6 vs. 7-12 months of age, infants with socioeconomic and nutritional risk factors).
• Manufacturing and Feasibility. FDA is seeking information on any manufacturing and feasibility challenges associated with the proposed requirements.
• Nutrient Levels in Water. FDA is inviting data on the variability of nutrient levels in tap and bottled water in the U.S. and implications for infant formula manufacturing.

Comments on the proposed rule are due March 2, 2027. Given FDA's phased approach, stakeholders should anticipate the two additional proposed rules addressing the remaining nutrients. FDA proposes a compliance date of three years after the effective date of the final rule. FDA acknowledges in the proposed rule that formulation changes to comply with updated requirements could trigger notification obligations under section 412 of the FDCA; manufacturers would need to assess separately whether any such notifications would be required.