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.