Federal Regulation of Probiotics

An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Frameworks

Food and Drug Law Journal article based on project white paper
69 Food and Drug Law Journal 237 (2014)

Final Project White Paper (November 15 2012, rev'd September 2013, rev'd January 2016)

Federal Regulation of Probiotics Working Group Participant List

"Probiotics: Finding the Right Regulatory Balance," Science 18 October 2013: Vol. 342 no. 6156 pp. 314-315

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 has brought together a group of stakeholders and experts three times to work with them on the project. These meetings were held on June 14, 2010, February 3-4, 2011, and February 16-17, 2012. The Working Group includes NIH-funded researchers and administrators, food and drug law attorneys, government regulators, legal academics, consumer advocates and industry representatives. 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 three working group meetings, including the participant list, agenda and documents handed out in advance of the meetings are available on this website (see tab on right). In addition, we will post additional pertinent documents that relate to the project.