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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

Use of nonhuman data

a

Appeared to rely mostly on human data, although some animal data are mentioned

Description of limitations

a

a

Description of literature search strategy

General types of sources are described, but specifics of the search strategy are not

General types of sources are described but specifics of the search strategy are not

Use of current literature

Original Commission E monographs were completed in 1994; assessment of literature used is not possible because it is not cited

Includes references from the year 2000

Starting assumptions/appearance of impartiality

Translation sponsored by ABC (including corporate members), but it is assumed to replicate the original Commission E findings

Sponsored by ABC (including corporate members)

Use of peer review

a

Text indicates “streamlined peer review process” was employed, but also indicates additional information provided in the expanded text was not subject to the level of review conducted by Commission E

Focus on a particular standardized product and discussion of preparation impact on safety

Preparation impact on safety is not specifically discussed; safety conclusions are assumed to be based on standardizations described because conclusions were made for the German marketplace

Specific preparations were not addressed except for two botanicals (Echinacea and hawthorne), where confusion existed from Commission E; safety conclusions are based on products standardized for the German marketplace

Description of consumption levels considered

Recommendations for therapeutic doses are included, so it is assumed that these are the intake levels on which safety judgments are made

Recommendations for therapeutic doses as in the Commission E translation, so it is assumed that these are the intake levels on which safety judgments are made

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55
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)