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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 current literature

Current literature, updated every 3–18 months

Mostly current, some historical information

Starting assumptions/appearance of impartiality

 

Appears to give favorable consideration toward the approved German Commission E monographs (the basis for about half of the monographs) as “approved by the Commission E,” without critical evaluation

Use of peer review

Introductory information describes an evidencedbased, consensus-based, peer review

No indication of peer review found

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

Does not appear to focus on specific preparations

A number of different preparations are described, impact on safety is described for some; for monographs based on conclusions of Commission E, usefulness of conclusions depends on similarities of German products to products consumed in the United States

Description of consumption levels considered

A recommended use amount is described; it is assumed that safety conclusions are based on this amount

Recommended doses are described

Consideration of data from non-oral routes of exposure

No mention is made of how non-oral data were handled in the example reviewed

No mention is made of how non-oral data were handled

Discussion of biological activity or possible mechanism of action

Discussed

Addressed, but not necessarily with safety in mind

Discussion of specific groups within the general population, if appropriate

Pregnant and lactating women are addressed

Second edition has separate indexes for herbs not for use during pregnancy or lactation or for use only under supervision

Interaction with other interventions

Thorough section on interactions with conventional therapies, drugs, other herbs, and supplements

Interactions discussed and a Drug/Herb Interaction Guide is included

Page
60
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)