Infant formula is a primary or supplementary source of nutrition for many infants in the U.S. Consequently, disruptions to the supply of infant formula can have a severe impact on infants' health and well-being. In late 2021 and early 2022, a recall of specific infant formula products, followed by a pause in production, resulted in a widespread, national shortage. The incident demonstrated that additional risk management planning is needed to protect infants from the consequences of potential future supply chain disruptions. In 2023, the U.S. Food and Drug Administration contracted with the National Academies to convene an expert committee to examine and report on challenges in supply, market competition, and regulation of infant formula. The resulting consensus study report explains policy and marketplace vulnerabilities that were exposed during the shortage, describes the extent to which actions taken by relevant stakeholders addressed these vulnerabilities, identifies remaining gaps in the system, and recommends actions to reduce the risk and lessen the effect of any future disruption to the infant formula supply chain.

Infant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. They are critical to infant health since they must safely support growth and development during a period when the consequences on inadequate nutrition are most severe. Existing guidelines and regulations for evaluating the safety of conventional food ingredients (e.g., vitamins and minerals) added to infant formulas have worked well in the past; however they are not sufficient to address the diversity of potential new ingredients proposed by manufacturers to develop formulas that mimic the perceived and potential benefits of human milk. This book, prepared at the request of the Food and Drug Administration (FDA) and Health Canada, addresses the regulatory and research issues that are critical in assessing the safety of the addition of new ingredients to infants.