Special Issue from Advances in Nutrition
The CDC estimates that 73% of U.S. infants receive infant formula at some point in their first year. For some infants, formula may provide the sole source of nutrition during the first 4-6 months. Despite new discoveries in infant nutrition, infant formula regulations have remained largely unchanged since the 1980s. In response, in March 2025, the Food and Drug Administration launched Operation Stork Speed, an initiative to comprehensively revise infant formula recommendations in light of four decades of accumulated scientific evidence.
In June 2025, Operation Stork Speed convened a panel of experts from academia, industry, and community stakeholders to address infant formula nutrient specifications, regulatory frameworks, safety protocols, marketing practices, and specialized applications.
The three papers, as well as the accompanying Editorial, Charting a New Era to Modernize U.S. Infant Formula Regulation, in this Special Issue of Advances in Nutrition represent the recommendations of the panel, offering a comprehensive blueprint for aligning U.S. standards with global evidence. These papers underscore the urgent need to apply the latest evidence-based science to improve infant nutrition and health outcomes, reduce health disparities, and foster innovation while prioritizing human milk as the gold standard:
Part One describes current FDA guidelines, highlighting inadequate standards and raising concerns about the levels of several macronutrients. For example, the authors note that “surprisingly, over half of U.S. infant formula substitute lactose, the primary human milk carbohydrate, with glucose polymers like corn syrup solids, which have been linked to excess weight gain and altered gut microbiota in observational studies.” In addition, a review of micronutrients revealed the need to reduce the iron content in routine formulas, consistent with European Food Safety Authority recommendations and emerging safety data. The review also revealed the need to set upper limits for the concentration of calcium and phosphorus.
Current FDA processes to regulate infant formulas are at times slow and complex, making it difficult for new infant formulas to enter the market. In response, Part Two recommends a centralized Food and Drug Administration database of infant formulas to support caregivers and healthcare professionals in making evidence-based decisions. Moreover, to address safety gaps, the authors advocate replacing outdated testing that focuses on protein and growth with New Approach Methods (NAMS). These NAMS include high-throughput screening using human infant gut enteroids and neonatal swine models, “which may offer more predictive alternatives for functional and toxicity assessment of new infant formula ingredients and finished products.”
Part Three emphasizes “ongoing challenges in the availability, regulation, and development of preterm infant nutrition products and the critical need for continued research and development to expand the diversity of specialized preterm infant formula.” For example, while Operation Stork Speed focuses on infant formula for term infants, many infants in the Neonatal Intensive Care Unit (NICU) require infant formula to meet their nutritional needs. NICU practices prioritize feeding human milk; however, not all mothers can provide sufficient milk. Pasteurized donor milk is recommended as a supplement to mother’s own milk for preterm infants, but is not routinely accessible in all NICUs. As a results, infant formula often remains the only feasible feeding option for these vulnerable infants.
Collectively, the authors note that the articles in Food and Drug Administration Expert Panel on Infant Formula “Operation Stork Speed” call for “Operation Stork Speed to serve as a catalyst for modernizing an outdated system to evaluate the nutritional adequacy and safety of infant formula in the U.S. Implementing these recommendations could lead to products that are nutritionally superior and safer.”
All articles in this Special Issue of Advances in Nutrition are accessible at no cost to all readers regardless of subscription status. For clinicians and researchers, the recommendations offer a framework for evaluating infant formula using advanced preclinical and clinical approaches.
Eric Graber
Eric Graber is a freelance copy writer and marketing consultant, working primarily for publishers and professional associations in science and medicine. He has a BA in Spanish Literature from Columbia University and an MBA in marketing from NYU Stern School of Business.
