Review of Infant Formula Nutrient Requirements
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The Office of Critical Foods within the FDA’s Human Foods Program is seeking a contractor to conduct a comprehensive scientific review of nutrient requirements for infant formula, as mandated by the Food and Drug Omnibus Reform Act of 2022. This effort is part of Operation Stork Speed, a multi-agency initiative to ensure a reliable, safe, and nutritious supply of infant formula for U.S. infants, who often rely on it as their sole source of nutrition. The review must cover fourteen specific nutrients—protein, fat, linoleic acid, carbohydrates, iron, copper, zinc, calcium, phosphorus, magnesium, vitamin K, DHA, ARA, alpha-linolenic acid, and L-carnitine—and produce detailed assessments for each, including dietary reference intakes from national and international bodies, human milk composition data, daily intake estimates, nutrient functions and metabolism, deficiency and toxicity profiles, and current scientific literature on health outcomes and safety. The contractor is also required to evaluate existing regulatory standards under 21 CFR 107.100(a) and propose evidence-based revisions in alignment with the latest research and global infant formula standards. This contractual requirement is critical to fulfilling FDORA’s mandate for a quadrennial review of infant formula nutrient standards, the first of which is scheduled to begin in 2026. The contractor must deliver individual, high-quality Microsoft Word files for each nutrient, incorporating not only scientific data but also contextual considerations such as nutrient contributions from water used to reconstitute powdered formula and other dietary sources. The ultimate goal is to inform FDA’s regulatory decisions and ensure that infant formulas marketed in the United States continue to meet the evolving nutritional needs of healthy, full-term infants based on the most up-to-date and globally relevant science. The solicitation, issued under number 75F40126R00060, has a response deadline of July 27, 2026, and is managed by the FDA’s Office of Acquisition and Grant Services with primary point of contact Amanda Edger. The work will be conducted in support of the agency’s broader mission to safeguard infant health through science-based nutritional standards.
General Info
Agency
NAICS
Place of Performance
College Park, MD, USASet-Aside
Timeline
Response Deadline
Organization & Contact Information
Full Description
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.