Summary of the Joint National Institutes of Health and the Food and Drug Administration Workshop Titled “Exploring the Science Surrounding the Safe Use of Bioactive Ingredients in Infant Formula: Considerations for an Assessment Framework”

The US government and many professional societies recommend that human milk be the sole source of nutrition for infants up to 6 months-of-age.1,2 However, only about 25% of infants in the US meet this goal signaling an urgent need for improved multi-level support for breastfeeding among societies, communities, and families.2 In addition, when breastfeeding is not possible, access to a safe and effective source of nutrition—provided by infant formula (IF) is critical. The search for bioactive ingredients found in human milk (HM) that could be added to formula has been intense among academic institutions, governmental research institutes, and industry.