U. MD. Hosts Consensus Conference to Consider Options for Federal Regulation of Probiotics – HP&M Included among FDA Legal Experts

By Wes Siegner –   

On June 14, 2010, The University of Maryland School of Law hosted the first of a series of multidisciplinary meetings being held as part of a Human Microbiome Project ELSI (Ethical, Legal, Social Implications) grant to study federal regulation of probiotics.  The team that received the grant included:

• 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

Participants in the conference included members of academia and the scientific research, business, legal and federal regulatory communities.  The National Institutes of Health and the Federal Trade Commission are participating in the study, and representatives from the Food and Drug Administration attended as observers.  The agenda for the first meeting, including speakers for the first day, can be found here.

The first all-day meeting focused on achieving a broad-based understanding of the science relating to probiotics and the current federal regulatory framework into which products containing probiotics fall.  As planned, this meeting was a question-generating session.  Subsequent sessions will focus more on attempting to find consensus answers to the complex regulatory questions that surround products containing probiotics.  The next meeting is being planned for January 2011.