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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Description of literature search strategy	Well-defined search strategy, including databases and key words used	Strategy was not described in detail
Use of current literature	Examples reviewed were very current at time of publication, no explanation of updates	Monographs published periodically since 1997; older publications, as well as citations within 5 years of publication, were included
Starting assumptions/appearance of impartiality		A lack of information appears to be interpreted as safety
Use of peer review	Peer reviewed	Outside peer reviewers are used
Focus on a particular standardized product and discussion of preparation impact on safety	Discusses different preparations and where effect of preparation on safety issues is unclear	Preparations are described, but impact of preparation on safety is not specifically described
Description of consumption levels considered	Ingested amount under consideration is described	Recommended levels are described; it is assumed that the safety conclusions are based on these levels
Consideration of data from non-oral routes of exposure	No mention is made of how non-oral data were handled; in the example reviewed, non-oral data were referred to in some sections, but it is not clear if these data are considered as possibly relevant for safety of oral consumption of the ingredient	Non-oral data are referred to in some sections, but it is not clear if these data are considered as possibly relevant for safety of oral consumption of the ingredient
Discussion of biological activity or possible mechanism of action	Addressed	Discussion is included, but implication for safety is not discussed
Discussion of specific groups within the general population, if appropriate	No recommendations for specific groups in the examples reviewed; for ephedra, the panel was asked to consider safety in children, adolescents, young athletes, and adults, but conclusions on safety are not specific for these groups	Precautions for pregnant and lactating women are given in the examples reviewed, but not for children or other groups

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