Federal Regulation of Probiotics
An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Frameworks
A team of researchers at the University of Maryland Baltimore is studying federal regulation of probiotics under a grant from NIH's Human Microbiome Project (HMP). A portion of HMP funds were set aside to study the Ethical, Legal, and Social Implications (often referred to as the ELSI issues) of the Project's scientific goals. The probiotics project is an interdisciplinary collaboration between faculty members from the University of Maryland Schools of Law, Pharmacy and Medicine. The members of the University of Maryland team are:
- Diane E. Hoffmann, MS, JD, Associate Dean for Academic Programs and Director, Law and Health Care Program, University of Maryland School of Law (Principal Investigator)
- Claire M. Fraser-Liggett, Ph.D, Professor of Medicine and Director, Institute for Genome Sciences, University of Maryland School of Medicine
- Frank Palumbo, Ph.D, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy
- Jacques Ravel, Ph.D, Associate Professor, Institute for Genome Sciences, University of Maryland School of Medicine
- Virginia Rowthorn, JD, Managing Director, Law & Health Care Program, University of Maryland School of Law
- Jack Schwartz, JD, Visiting Professor and Health Law & Policy Fellow, University of Maryland School of Law
The University of Maryland research team convened a group of stakeholders and experts (the "Working Group") in the area of probiotics to work with them on the project. The Working Group includes NIH-funded researchers and administrators, food and drug law attorneys, government regulators, legal academics, consumer advocates and industry representatives. The first meeting of the Working Group was held on June 14, 2010 at the University of Maryland School of Law. The goal of this collaborative project is to create a healthy debate among the experts, study the legal and regulatory issues surrounding probiotics, and attempt to come to a consensus on how they should be regulated.
Documents from the first Working Group meeting, including the participant list, agenda and documents handed out in advance of the meeting are available on this website. In addition, we will post additional pertinent documents that relate to the project. In the future, we will post information about future meetings of the Working Group.
