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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Interaction with other interventions	Interaction with caffeine discussed extensively in the ephedra report; not discussed in other examples reviewed	Interactions discussed in the examples reviewed
Other comments and considerations for using this resource	AHRQ reviews are extensive reviews of health care practices Thorough resource for those supplements considered; less useful due to small number of supplements included to date: garlic, milk thistle, SAMe (S-adenosyl-L-methionine), and ephedra	Only 18 monographs are available to date; starting assumption appears to be one of safety, therefore a lack of information appears to be interpreted as safe This is a useful resource to understand use levels, stability, and analytical methods, but the literature search on safety information may not be sufficiently comprehensive for all ingredients considered
	Resource
Considerations	American Herbal Products Association Botanical Safety Handbook (McGuffin et al., 1997)	Institute of Medicine (IOM) Dietary Reference Intakes—Tolerable Upper Intake Levels (ULs) (IOM, 1997, 1998a, 1998b, 2000, 2001, 2002, 2004)
Type of organization responsible for resource	Nonprofit trade association representing the herbal products industry	Prepared by expert panels assembled by the IOM of the National Academies (Nonprofit organization chartered to give advice to the government)
Substances reviewed	Botanicals sold in North America	Essential vitamins, minerals, and electrolytes, as well as macronutrients and water
Product/endpoint	Book; safety classifications of botanicals	Chapter sections; component of Dietary Reference Intakes publications
Focus on safety/risk	Safety is primary focus	Safety is primary focus; specifically, determining the level at which nutrient intake may cause adverse effects

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