Executive Summary: Scientific and Regulatory Challenges of Development of Probiotics as Foods and Drugs

uses of probiotics along with current knowledge of probiotic organisms, their properties, and their mechanisms of action. The program included scientific presentations about advances in understanding of the relationship between the gastrointestinal microbiota and the development of the innate and adaptive immune system, as well as the implications of this relationship for current uses of and research on probiotics (table 1). Unlike other workshops held to date, the program examined the critically important interface between science and regulation. Speakers addressed the impact that science has on the way in which products are regulated and the equally important impact that regulations have on how research is planned and conducted, how product information is conveyed to consumers and health care professionals, and how products are ultimately marketed. The articles and discussions in this supplement address these topics that were presented in each panel. This article summarizes the findings of the conference and the recommendations made for future directions relating to research on probiotics.