Claire Kruger

Environ International

Gilbert A. Leveille

Consultant

Jeffrey Lipsius

Threshold Enterprises

Peter Ludwell

The Law Loft

Richard Malter

Retired

Hulon McClain

Whitehall-Robins Healthcare

David Roll

United States Pharmacopeia

Alan Rulis

Food and Drug Administration

Louis Scarano

Environmental Protection Agency

David Schardt

Center for Science in the Public Interest

Bruce Silverglade

Center for Science in the Public Interest

R. William Soller

Consumer Healthcare Products Association

Christine Lewis Taylor

Food and Drug Administration

Thomas N. Tiedt

Med-Tox Group

Susan Trimbo

Nutricia

Roy Upton

American Herbal Pharmacopoeia

José Vergés

BIOIBÉRICA S.A.

John Vincent

University of Alabama

John Walker

Environmental Protection Agency

Sidney Wolfe

Public Citizen’s Health Research Group

Snow Wynter

Dietary Supplement Quality

Anthony Young

American Herbal Products Association

Front Matter (R1-R20)

Executive Summary (1-18)

1 Introduction and Background (19-42)

2 Approaches Used by Others and Existing Safety Frameworks (43-84)

3 The Framework (85-125)

4 Categories of Scientific Evidence--Human Information and Data (126-155)

5 Categories of Scientific Evidence--Animal Data (156-174)

6 Categories of Scientific Evidence--Information About Related Substances (175-216)

7 Categories of Scientific Evidence--In Vitro Data (217-234)

8 Interactions (235-246)

9 Vulnerable Groups and Prevalance of Use (247-252)

10 Scientific Principles for Integrating and Evaluating the Available Data (253-268)

11 Applying the Framework: Case Studies Using the Prototype Safety Monographs (269-291)

12 Factors Influencing Use of the Safety Framework (292-296)

13 Findings and Recommendations (297-306)

Appendix A: Existing Frameworks or Systems for Evaluating the Safety of Other Substances (307-315)

Appendix B: Scope of Work and Comments to Initial July 2002 Framework (316-321)

Appendix C: Plant Family Information (322-355)

Appendix D: Chaparral: Prototype Monograph Summary (356-362)

Appendix E: Glucosamine: Prototype Monograph Summary (363-366)

Appendix F: Melatonin: Prototype Monograph Summary (367-371)

Appendix G: Chromium Picolinate: Prototype Monograph Summary (372-375)

Appendix H: Saw Palmetto: Prototype Monograph Summary (376-379)

Appendix I: Shark Cartilage: Prototype Monograph Summary (380-384)

Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral (385-449)

Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women (450-477)

Appendix L: Acknowledgements (478-480)

Appendix M: Biographical Sketches of Commitee Members (481-488)

Index (489-506)