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: FDA’s 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