FOOD ADVISORY COMMITTEE and DIETARY SUPPLEMENTS SUBCOMMITTEE

GLUCOSAMINE AND CHONDROITIN SULFATE

AND OSTEOARTHRITIS

 

June 7-8, 2004

 

Tentative Agenda[1]

 

June 7, 2004 - Monday

 

8:00 Welcome and Member Introduction

Dr. Sanford A. Miller

Chairman, Food Advisory Committee (FAC)

 

8:20 Conflict of Interest Statement

Linda Reed

Acting Executive Secretary, FAC

 

8:30 Opening Remarks

Dr. Robert E. Brackett

Director, Center for Food Safety and Applied Nutrition (CFSAN)

 

8:35 Background and Questions to Committee

Dr. Barbara O. Schneeman

Director, Office of Nutritional Products, Labeling, and Dietary Supplements, (ONPLDS)/CFSAN

 

8:45 Questions and Clarification

 

8:50 Overview of Legal Framework

Louisa Nickerson, Office of General Counsel/FDA

 

9:05 Questions and Clarification

 

9:10 Overview of Petitions: FDAs Review Process and Issues

Dr. Craig Rowlands, Biologist, FDA/ONPLDS/CFSAN

 

9:40 Questions and Clarification

 

10:05 Break

 

10:20 Petitioner: Weider Nutrition International, Inc

Dr. Luke R. Bucci, Vice President of Research, Weider Nutrition Group

 

11:05 Questions and Clarifications

 

 

 

11:20 Petitioner: Rotta Pharmaceutical, Inc

Dr. Roy D. Altman, Professor of Medicine and Rheumatology, University of Miami and University of California-Los Angeles

 

Dr. Lucio C. Rovati, Executive Medical Director, Rotta Research Laboratory

 

12:05 Questions and Clarifications

 

12:20 Lunch

 

1:35 Current State of the Science on Etiology of OA and Modifiable Risk Factors for OA

Dr. Lee Simon, Harvard University

 

2:20 Questions and Clarifications

2:25 The Role of Animal and in vitro Models in OA Risk Reduction

Dr. James Witter, Center for Drug Evaluation and Research/FDA

 

2:55 Questions and Clarification

 

3:10 Break

 

3:25 Public Comment

 

4:50 Questions and Clarification

 

5:00 Adjourn

 

June 8, 2004 - Tuesday

 

8:00 Call to Order, Review of Charge and Questions

Committee Chair

 

8:15 Review of Issues

Dr. Craig Rowlands, FDA/ONPLDS/CFSAN

 

8:35 Questions and Clarifications

 

8:40 Committee Discussion

 

10:00 Break

 

10:15 Committee Discussion (Continued)

 

11:30 Lunch

 

12:30 Concluding Deliberations, Recommendations, Response to Charges and Vote

 

1:30 Concluding Comments

Committee Chair

 

1:45 Meeting Adjourns



[1] The times indicated on this tentative agenda are approximations. Breaks will also be called as deemed appropriate by the Chairman.