FDA Expert Panel on Infant Formula “Operation Stork Speed” June 2025: Part 1, Nutrient Considerations

Operation Stork Speed, launched by the Food and Drug Administration(FDA) in March 2025, represents a comprehensive initiative to update infant formula regulations that have remained largely unchanged since the 1980’s. This expert panel review addresses recommendations for nutrients considering four decades of accumulated scientific evidence since then. Current FDA fatty acid regulations specify only total fat content and minimum linoleic acid requirements despite substantial international consensus on polyunsaturated fatty acid specifications. Evidence strongly supports establishing maximum linoleic acid levels and docosahexaenoic acid (DHA) and arachidonic acid (ARA) requirements, reflecting the critical role of omega-3 fatty acids in neurocognitive development and visual acuity. The panel emphasizes that saturated and monounsaturated fatty acids comprise over 80% of human milk fatty acids, while acknowledging recent concerns about seed oils and supporting balanced PUFA formulations. Carbohydrate composition presents significant concerns, as over half of US formulas contain glucose polymers (e.g. corn syrup solids) despite lactose being the primary carbohydrate energy source in human milk. Observational studies link corn syrup-based formulas to multiple possible health risks, including excess weight gain, warranting reconsideration of the value of non-lactose carbohydrate substitutions in formulas for healthy children. Protein content recommendations support decreasing the upper range of allowable intake, aligning with European standards and addressing concerns about excessive protein intake contributing to later obesity risk. Micronutrient evaluation reveals the need to reduce the iron content in routine formulas to lower levels, consistent with European Food Safety Authority recommendations and emerging safety data and a need to set upper limits for the concentration of calcium and phosphorus. Overall, infant formula is a healthy product and has many decades of successfully feeding infants. These comprehensive updates aim to more closely align US infant formula regulations with current scientific understanding and international standards while supporting optimal infant growth, development, and long-term health outcomes.