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Author Notes:

CONTACT Mary Ellen Sanders mes@mesanders.com, International Scientific Association for Probiotics and Prebiotics, 7119 S. Glencoe Ct., Centennial, CO 80122 USA

The authors are grateful to all additional participants in this working group, including Pat Hibberd, Massachusetts General Hospital, Boston; Richard Oberhelman, Tulane; Girish Deshpande, Nepean Hospital Sydney; Peter Marks, FDA CBER; Chris Elkins, FDA CFSAN; Jennifer Patro, FDA CFSAN; Linda Duffy, NIH-NCCIH; Martin Hahn, Hogan Lovells; Sarah Roller, Kelley Drye & Warren LLP; Diane Hoffmann, University of Maryland School of Law; Tina Tan, Georgetown University; Greg Leyer, UAS; David Keller, Ganeden Biotech; Solange Henoud, Lallemand Health Solutions; Thomas Tompkins, Lallemand Health Solutions; Berenice Ocampo Guevara, Mead Johnson Nutrition; Seema Mody, DSM; Danielle de Montigny, Biok-K+ International Inc.; Wafaa Ayad, Church & Dwight.

DJM has been a scientific expert about marketing claims for a probiotic product for General Mills, Bayer, Procter & Gamble and Nestle.

Dannon, Lifeway, Nestle and Cargill have provided Georgetown funding for separate clinical trials. MES has been a consultant for numerous probiotic food and supplement companies and receives financial remuneration from ISAPP for her role as Executive Science Officer.

ALS received a research grant through Emory University from the Gerber Foundation and an unrestricted donation of probiotic and placebo product from BioGaia from 2012-2014 for a research study.

Subjects:

Research Funding:

Authors would like to acknowledge ISAPP for their encouragement and financial support to attend the workshop

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Gastroenterology & Hepatology
  • Microbiology
  • CBER
  • CFSAN
  • FDA
  • probiotic
  • regulatory

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

Tools:

Journal Title:

Gut Microbes

Volume:

Volume 7, Number 2

Publisher:

, Pages 97-100

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© 2016, © Mary Ellen Sanders, Andi L. Shane, and Daniel J. Merenstein.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License (http://creativecommons.org/licenses/by-nc-sa/3.0/).

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