Review of Infant Formula Nutrient Requirements

The Office of Critical Foods (OCF) Infant Formula Premarket Review Staff (IFPRS) within the Food and Drug Administration’s (FDA) Human Foods Program (HFP) Nutrition Center of Excellence (NCE) is seeking information to assess the feasibility of fulfilling a highly specialized requirement related to the comprehensive review of infant formula nutrient requirements mandated by the Food and Drug Omnibus Reform Act (FDORA) and a component of Operation Stork Speed.

In March 2025, in coordination with the Department of Health and Human Services (HHS), FDA launched Operation Stork Speed (OSS)— a multi-pronged initiative to expand options for safe, reliable, and nutritious infant formula for American families. These enhanced commitments are focused on making sure a strong supply of infant formula—which is often the sole source of nutrition for infants—remains available for one of our nation’s most vulnerable populations. FDORA, enacted as part of the Consolidated Appropriations Act of 2023, mandates that FDA review infant formula nutrient requirements every four years, as appropriate, with the first review commencing in 2026. Although FDA regularly reviews individual nutrient requirements for infant formulas, the last comprehensive review was in 1998.

This comprehensive nutrient review for infant formulas intended for healthy, full-term infants will incorporate the latest scientific findings regarding human milk composition, infant nutritional needs, and developmental requirements to ensure infant formula products support healthy growth and development and help inform our regulatory decision-making. This process will ensure that infants benefit from the most up-to-date science and innovation as research continues to advance our understanding of infants’ dietary needs.

The Contractor shall obtain a comprehensive review of fourteen different nutrients for infant formula, including protein, fat, linoleic acid, carbohydrates, iron, copper, zinc, calcium, phosphorus, magnesium, vitamin K, DHA, ARA, alpha-linolenic acid, and L-carnitine.

• Obtain, for each nutrient, a unique Microsoft Word file including:

o National and International Expert Body Dietary Reference Intakes (DRIs) for healthy term infants.

o Global infant formula nutrient standards and recommendations (per 100 kcal).

o Nutrient content of human milk.

o Daily intake estimation, including comparison with DRIs and human milk exposure.

o A brief background on the nutrient, including function and metabolism, biomarkers, deficiency and toxicity, and nutrient interactions.

o Additional considerations. For example, other dietary sources of the nutrient, such as water used to reconstitute powdered infant formula.

o New or emerging scientific evidence regarding the nutrient, including clinical studies and health outcomes, safety data, and mechanistic studies.

• Proposed action and justification related to current requirements in 21 CFR 107.100(a).

• Fulfill the requirement of the Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted as part of the Consolidated Appropriations Act of 2023, that FDA review infant formula nutrient requirements every four years, as appropriate, with the first review commencing in 2026. Per FDORA, such review must consider any new scientific data or information related to infant formula nutrients, including international infant formula standards.

• Use the information to initiate appropriate action to ensure that infant formulas marketed in the United States are nutritionally adequate to support healthy growth and development in infants.