Programs & Centers

Federal Regulation of Probiotics

Second Meeting Materials and Summary

February 3-4, 2011

IND Lite Issue
“FDA Draft Guidance - Guidance for Industry Investigational New Drug Applications (INDs)— Determining Whether Human Research Studies Can Be Conducted Without an IND” (this recent guidance recommends that virtually any product with live components requires an IND)
Comment of Draft IND Guidance by the International Scientific Association for Probiotics and Prebiotics (ISAPP)
Health Claims
“The Cost of Inadequate Substantiation,” Paul Hyman and Ricardo Carvajal, Food Chemical News
“Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims,” GAO-11-102, January 14, 2011
“Group Plans Certification Seal for Diet Supplements,” USA Today 12/17/2001
“Litigation as a Tool in Food Advertising: A Consumer Advocacy Viewpoint,” Stephen Gardner, 39 LOY. L.A. L. REV. 291, 309 (2006)
Characterization
FDA Guidance for Industry - Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (on page 6 requirements are set forth for characterization requirements for live biotherapeutic products)
“The Enema of Your Enemy is Your Friend: Fecal transplants could be a cheap and effective treatment for gastrointestinal disorders,” , Emily P. Walker, Jan. 27, 2011
FDA Guidance for Industry Botanical Drug: Chemistry, Manufacturing, and Controls (CMC) (on page 10 requirements for characterization of botanicals in the IND process)
Monograph
Health Canada Probiotics Monograph
Jim O’Reilly’s proposal

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Copyright © 2014, University of Maryland Francis King Carey School of Law. All Rights Reserved