Human Milk as a Model for Next-Generation Infant Formula: Opportunities and Challenges

Human milk (HM) is a dynamic biological system replete with functional components that support infant growth, development and immune protection. HM is regarded as the optimal infant food; however, many infants rely on infant formula (IF) as their sole source of nutrition or as a supplement to HM. Although many ingredients have been added to IF over the past 30 years, it is not equivalent to HM in terms of composition or infant outcomes. Potential opportunities to improve IF composition include adding components extracted from the milk of other species, synthesized by precision fermentation or produced by cultured mammary epithelial cells. However, many hurdles remain to adding novel ingredients to IF, including determining how much to add to best align with variable HM composition, ensuring reasonable certainty of no harm, considering possible functional effects of the ingredients, establishing methods to assess the safety of the IF when the functional ingredient is added and determining how best to assess functional outcomes. Advancing the field to improve infant health hinges on achieving consensus across a range of questions among academic, industry and regulatory scientists. Statement of Significance There is a critical need to improve the quality of IF for the many infants and their caregivers who rely on it to meet their nutritional needs. This work presents an integrated perspective from authors and non-author contributors from a tripartite coalition, the Infant Nutrition Science Coalition, comprising researchers from academia, industry and government on the current opportunities provided by emerging technologies to enhance IF’s similarity to HM, the challenges to the incorporation of novel ingredients and the need for consensus building to drive improvements in IF.