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Dietary Supplements: A Framework for Evaluating Safety (2005)
Institute of Medicine (IOM)

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. "Front Matter." Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press, 2005.

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Dietary Supplements: A Framework for Evaluating Safety

COMMITTEE ON THE FRAMEWORK FOR EVALUATING THE SAFETY OF DIETARY SUPPLEMENTS

BARBARA O. SCHNEEMAN (Chair),

Departments of Nutrition and Food Science, Division of Clinical Nutrition and Metabolism, and Office of University Outreach, University of California, Davis

DANIEL L. AZARNOFF,

D.L. Azarnoff Associates and Clinical/ Regulatory Affairs, Cellegy Pharmaceuticals, South San Francisco, California

CINDY LYNN CHRISTIANSEN,

Center for Health Quality, Outcomes, and Economic Research, Bedford V.A. Hospital, and Boston University School of Public Health, Massachusetts

ALICE M. CLARK,

Office of Research and Sponsored Programs, University of Mississippi, Oxford

NORMAN R. FARNSWORTH,

Department of Medicinal Chemistry and Pharmacognosy, University of Illinois at Chicago

TED GANSLER,

Medical Information Strategy, American Cancer Society, Atlanta, Georgia

JAMES E. GIBSON,

Department of Pharmacology and Toxicology, The Brody School of Medicine at East Carolina University, North Carolina

STEPHEN A. GOLDMAN,

Stephen A. Goldman Consulting Services, LLC, Morris Plains, New Jersey

PHILIP S. GUZELIAN,

Department of Medicine, University of Colorado Health Sciences Center, Denver

ELIZABETH JEFFERY,

Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign

LOREN D. KOLLER,

Loren Koller and Associates, LLC, Corvallis, Oregon

JOSEPH LAU,

Institute for Clinical Research and Health Policy Studies, Tufts New England Medical Center, Boston, Massachusetts

RUSSELL J. MOLYNEUX,

USDA Western Regional Research Center, Albany, California

SUSAN S. PERCIVAL,

Department of Food Science and Human Nutrition, University of Florida, Gainesville

CHERYL L. ROCK,

Department of Family and Preventive Medicine, University of California, San Diego, La Jolla

JERROLD M. WARD,

Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland

Page
IV
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)