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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Primary Genera of Concern	Family	Compounds and Compound Classes Implicated in Toxicity
Phoradendron	Loranthaceae	Pressor amines
Physostigma	Fabaceae	Physostigmine (eserine)
Phytolacca	Phytolaccaceae	Saponins
Pilocarpus	Rutaceae	Pilocarpine
Pinus	Pinaceae	Labdane diterpene acids
Podophyllum	Berberidaceae	Podophyllotoxin-type lignans
Polygonatum	Liliaceae	Steroidal saponins
Prosopsis	Fabaceae	Indouizidine alkaloids, β-nitropropionic acid, tyramine
Prunus^b	Rosaceae	Cyanogenic glycosides
Psilostrophe	Asteraceae	Unknown
Pteridium	Polypodiaceae	Ptaquiloside
Ranunculus	Ranunculaceae	Protoanemonin
Rheum^b	Polygonaceae	Oxalates, nitrates, anthraquinones
Rhododendron	Ericaceae	Grayanotoxins
Rhodomyrtus	Myrtaceae	Dibenzofurans
Ricinus	Euphorbiaceae	Ricin
Robinia	Fabaceae	Abrin
Rudbeckia	Asteraceae	Unknown
Rumex	Polygonaceae	Oxalates, nitrates
Sambucus	Caprifoliaceae	Cyanogenic
Sanguinaria	Papaveraceae	Sanguinarine
Saponaria	Caryophyllyaceae	Unknown
Sarcobatus	Polygonaceae	Oxalates, nitrates
Sarothamnus	Fabaceae	Sparteine
Sassafras	Lauraceae	Safrole
Scilla	Liliaceae	Cardiac glycosides

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