Analysis of Federal Regulatory Framework on Probiotics, Project

In 2009, researchers at the University of Maryland, Baltimore were awarded a three year grant from the National Institutes of Health as part of the Ethical, Legal and Social Issues (ELSI) component of the Human Microbiome Project (HMP), to examine and make recommendations regarding the regulation of probiotics. The UMB probiotics grant was one of the ELSI projects funded under the HMP. The project was an interdisciplinary collaboration between faculty members from the University of Maryland Schools of Law, Pharmacy, and Medicine. The NIH grant funded a number of meetings to explore the regulation of probiotics with a selected group of stakeholders and experts (the “Working Group”).

One of the most significant implications of the HMP is a potential expansion of the number of probiotic products available on the commercial market. Because this is a relatively new area of study, new claims are being made about the role and value of probiotics in promoting human health and well-being, and...