Probiotics: Achieving a Better Regulatory Fit

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of microorganisms within and across individuals, they are also promoting interest in the development of probiotic products. NIH set aside a portion of HMP funds to study the Ethical, Legal, and Social Implications (ELSI) of the HMP’s scientific goals. Among the funded ELSI studies was an effort to look at the current regulatory framework for probiotics and to determine if it is a good fit for the range of probiotics that are on the market, under development, or that may be developed in the future as a result of the HMP. This article reports on the findings of a Working Group consisting of NIH-funded HMP scientists, physicians, legal academics, government regulators, industry and consumer representatives, bioethicists, food and drug lawyers, and health policymakers who were assembled to address the adequacy of the current regulatory framework for probiotics under the HMP ELSI funded project. Specifically, after discussion of the features of probiotics that are relevant to their regulation and an overview of FDA’s current regulation of probiotics, the article addresses the following questions: 1) Do current regulations adequately address the safety of new probiotic products? 2) Should probiotic foods and dietary supplements be classified as drugs and required to go through the drug approval process? 3) What types of product characterization requirements are appropriate for probiotics? 4) Are current claim regulations appropriate for probiotics and, if not, how might they be improved