Advancing probiotic research in humans in the United States: Challenges and strategies

• Type of Material: Article
• Authors: Mary Ellen Sanders, International Scientific Association for Probiotics and Prebiotics; Andi L Shane, Emory University; Daniel J. Merenstein, Georgetown University
• Language: English
• Date: 2016-01-01
• Publisher: Taylor & Francis: STM, Behavioural Science and Public Health Titles
• Publication Version: Final Published Version
• Copyright Statement: © 2016, © Mary Ellen Sanders, Andi L. Shane, and Daniel J. Merenstein.
• License: Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported
• Final Published Version (URL): http://dx.doi.org/10.1080/19490976.2016.1138198
• Title of Journal or Parent Work: Gut Microbes
• ISSN: 1949-0976
• Volume: 7
• Issue: 2
• Start Page: 97
• End Page: 100
• Grant/Funding Information: Authors would like to acknowledge ISAPP for their encouragement and financial support to attend the workshop
• Keywords: Life Sciences & Biomedicine; Science & Technology; regulatory; Microbiology; Gastroenterology & Hepatology; CFSAN; CBER; probiotic; FDA
• Research Categories: Health Sciences, Nutrition; Health Sciences, General

Abstract

ABSTRACT: This is a summary from a workshop convened as part of the 13thannual meeting of the International Scientific Association for Probiotics and Prebiotics. A group of 24 stakeholders, including clinical experts, researchers, federal government officials, funding agencies, lawyers and industry experts met to review the challenges of the current regulatory approach to human research on probiotics in the USA and to discuss ways to move research forward. There was agreement that some of the current regulatory requirements imposed on probiotic research in the United States hindered research progress and increased cost without improving study subject safety. Many situations were outlined by clinical investigators demonstrating the impact of regulatory delays on research progress. Additionally, research is compromised when study designs and outcomes require manipulation so as to invoke less burdensome regulatory requirements. These responses by investigators to regulatory requirements have placed United States' researchers at a disadvantage. The public ultimately suffer when research to clarify the role of these products on health is stalled. Workshop participants concurred that regulatory oversight should balance study subject vulnerability with documented safety for the intended use for the probiotic strain, and that human research on foods and supplements should not be be regulated as drug research. Challenges and potential improvement strategies are discussed.