U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling, and Dietary Supplements
March 28, 2000


AGENDA

FDA Public Meeting On Implementing The Pearson Court Decision and Other Health Claim Issues

DEPARTMENT OF EDUCATION AUDITORIUM
400 Maryland Avenue, SW
Washington, DC

April 4, 2000

OPENING REMARKS AND KEY ISSUES: (10:00 - 10:30 AM)

Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition

PANEL I: (10:30 - 11:45 AM)

SHOULD HEALTH CLAIMS BE ALLOWED ON DIETARY SUPPLEMENTS ON A BASIS OTHER THAN SIGNIFICANT SCIENTIFIC AGREEMENT? IF SO, WHAT SHOULD THAT BASIS BE AND WHAT ARE APPROPRIATE CRITERIA FOR MAKING DECISIONS ABOUT ALLOWING SUCH CLAIMS?

Jonathan W. Emord, Emord & Associates
Bruce Silverglade, Center for Science in the Public Interest
Bruce Chassy, University of Illinois
Annette Dickinson, Council for Responsible Nutrition
Alice Lichtenstein, Tufts University

FDA PANEL DISCUSSION:

Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition
Christine Lewis, Director, Office of Nutritional Products, Labeling, & Dietary Supplements
Michael M. Landa, Deputy Chief Counsel
Margaret Dotzel, Acting Associate Commissioner for Policy Rachel E. Behrman, Deputy Director, Office of Medical Policy, Center for Drug Evaluation and Research

LUNCH: (11:45 AM - 12:45 PM)

PANEL II: (12:45 - 2:00 PM)

IF SUCH HEALTH CLAIMS ON DIETARY SUPPLEMENTS ARE TO BE APPROPRIATELY QUALIFIED SO THAT CONSUMERS ARE NOT MISLED, WHAT SHOULD BE THE CHARACTERISTICS OF SUCH QUALIFYING LANGUAGE? SHOULD FDA REQUIRE ANY OTHER INFORMATION TO ASSIST CONSUMERS IN EVALUATING HEALTH CLAIMS AND PREVENT THEM FROM BEING MISLED?

Mario Teisl, University of Maine
Michelle Rusk, Federal Trade Commission
Scott Bass, National Nutritional Foods Association Representative
James S. Turner, Citizens for Health
Brett Kay, National Consumers League

FDA PANEL DISCUSSION:

Levitt, Lewis, Landa, Dotzel, Behrman

PANEL III: (2:00 - 3:45 PM)

SHOULD HEALTH CLAIMS GO BEYOND CLAIMS ABOUT REDUCING THE RISK OF A DISEASE TO INCLUDE CLAIMS ABOUT MITIGATION OR TREATMENT OF AN EXISTING DISEASE, OR ARE SUCH CLAIMS DRUG CLAIMS? WHERE IS THE BOUNDARY, IF ANY, BETWEEN THESE CLAIMS?

INTRODUCTION:

Christine Lewis, Director, Office of Nutritional Products, Labeling, & Dietary Supplements
Philip Derfler, Deputy Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture

Claudia A. Lewis-Eng, Emord & Associates
L. Hogan Holtgrewe, American Urological Association
William Soller, Consumer Healthcare Products Association
Marsha Cohen, Hastings College of the Law, University of California
Regina Hildwine, National Food Processors Association

FDA PANEL DISCUSSION:

Levitt, Lewis, Landa, Dotzel, Behrman

BREAK (3:45 - 4:00 PM)

REGISTERED SPEAKERS: (4:00 - 6:00 PM, 5 minutes per speaker)

FDA Public Meeting on Implementing the Pearson Court Decision and Related Issues for Health Claims (Registration and Comments Information)

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