Special issue of Advances in nutrition
The CDC estimates that 73% of US babies receive infant formula at some point in their first year. For some infants, formula may provide the only source of nutrition for the first 4-6 months. Despite new discoveries in infant nutrition, the rules for infant formula have remained 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 nutritional specifications, regulatory frameworks, safety protocols, marketing practices, and special programs.
Three articles, as well as an accompanying editorial, A New Era Plan to Modernize the US Infant Formula Regulationin this Special issue Advances in nutrition Presenting the panel’s recommendations, they provide a comprehensive plan to align US standards with global evidence. These papers highlight the urgent need to apply the latest evidence-based science to improve child nutrition and health outcomes, reduce health disparities, and promote innovation while prioritizing human milk as the gold standard:
Part one describes current FDA guidelines that highlight inadequate standards and raise concerns about levels of several macronutrients. For example, the authors note, “Surprisingly, more than half of US infant formulas replace lactose, the primary carbohydrate of human milk, with glucose polymers such as corn syrup, which have been associated with increased weight gain and altered gut microbiota in observational studies.” In addition, the review of trace elements revealed the need to reduce the amount of iron in conventional formulas, consistent with the recommendations of the European Food Safety Authority and new safety data. The review also revealed the need to establish the upper limit of calcium and phosphorus concentration.
Current FDA processes for regulating infant formulas are sometimes slow and complex, making it difficult for new formulas to enter the market. In response, Part Two provides a centralized database of FDA recommendations on infant formula to support caregivers and health professionals in evidence-based decision making. Furthermore, to overcome the safety gaps, the authors advocate replacing the old test that focuses on protein and growth with a new approach (NAMS). This NAMS includes high-throughput screening using infant gut enteroids and neonatal pig models, “which may provide predictive alternatives for functional and toxicity evaluation of new infant formula ingredients and finished products.”
The third part highlights the “ongoing challenges in access, regulation and development of preterm infant nutrition products and the critical need for continued research and development to expand the variety of special formula for preterm infants.” For example, while Operation Stork Speed focuses on infant formula for term babies, many infants in the Neonatal Intensive Care Unit (NICU) require infant formula to meet their nutritional needs. NICU practices prioritize human milk feeding; but not all mothers can give enough milk. Pasteurized donor milk is recommended as a supplement to the mother’s own milk for premature infants, but is not routinely available in all NICUs. As a result, infant formula often remains the only viable feeding option for these vulnerable infants.
In general, 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 to modernize the antiquated system for evaluating the nutritional adequacy and safety of infant formula in the US. Implementation of these recommendations can lead to products that are nutritionally superior and safer.”
All articles in this special issue Advances in nutrition available for free to all readers regardless of subscription status. For clinicians and researchers, the recommendations provide a framework for evaluating infant formula using advanced clinical and clinical approaches.
