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

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. "2 Approaches Used by Others and Existing Safety Frameworks." 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

ducted; most resources indicated that they were. As with Question 10, however, it was not possible to determine if the peer reviewers had adequate expertise in the safety issues raised. It was also not possible to determine the degree to which reviewers’ comments were considered.

Questions 12 and 13, regarding the impact of preparation and focus on particular products, were answered together. The answer varies in importance, depending on whether the preparation of the ingredient varies significantly.

Question 14 asks whether ingested amounts under consideration were specified in the review. As indicated in the table, the committee assumed that specified “recommended” or “typical” ingestion levels were the basis of safety comments, but for resources that made conclusions, it would be useful for the reviews to explicitly state the amounts to which the conclusions apply.

Resources Related to Dietary Supplement Safety

A number of resources are available that have potential use for aiding in the evaluation of the safety of dietary supplement ingredients. The description of the resources that follow are based on information available from the organizations responsible or in published descriptions of the resources. Thus, the descriptions have not been verified further, and their inclusion in this report does not constitute endorsement of the approaches used or the information provided. While readily available resources are included, there are other resources and thus this group should not be considered inclusive of all efforts to consider safety, efficacy, or quality of dietary supplements.

Agency for Healthcare Research and Quality

AHRQ of the U.S. Department of Health and Human Services is authorized to sponsor, conduct, and disseminate research to improve the quality and effectiveness of health care (AHRQ, 2001). Other federal agencies, private sector agencies, and Congress periodically ask AHRQ to review and evaluate the scientific information on specified topics; their reviews are then used as the basis for clinical guidelines, performance measures, and other quality improvement tools. AHRQ administers the Evidence-based Practice Centers (EPCs), which have produced evidence reports requested by other federal agencies on the effectiveness and safety of a limited number of dietary supplements. The San Antonio EPC at the University of Texas Health Sciences Center, working under contract to AHRQ, has completed reports on garlic and milk thistle at the request of the National Center for Complementary and Alternative Medicine (NCCAM) of the National Insti-

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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)