Dietary Supplements: A Framework for Evaluating Safety

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Table of Contents
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

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Observed or Predicted Toxicity	Class^a	Other Comments
Anoxia, vasoconstriction, abortifacient, neurotoxic	A/B^d	Contamination with fungi
Hepatotoxic, carcinogenic	A
Hemorrhagic, circulatory system, collapse	A
Gastroenteritis, teratogenic Gastroenteritis, neurotoxicity	A
Abortifacient, gastroenteritis	A	Large amounts in livestock
Respiratory failure, coma, death teratogenic	A
Respiratory failure	B
Abortifacient	A
Gastroenteritis, vertigo	B	Seeds and pods
Convulsant	A
Hepatotoxic, carcinogenic	A	All parts
Abortifacient, gastroenteritis, teratogenic	A
Convulsant and coma	A
Photosensitization	B	Large amounts in livestock
Nephrotoxic	A	Teucrium chamaedrys of major concern
Cardiotoxic, death	A
Dermatitis, gastroenteritis	A	Poison ivy, poison sumac, Poison oak
Hepatotoxic, carcinogenic	A
Photosensitization Estrogenic	C
Respiratory depression	B
Immune suppressant, antispermatogenic	A
Hepatotoxic, carcinogenic	A
Cardiotoxic, death	A
Cyclopia, holoprosencephaly, limb defects	A
Neurotoxicity, teratogenic	A
Gastroenteritis	B
Heptotoxic, neurotoxic, death	A
Carcinogenic, neurotoxic, hepatoxic	A

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