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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

Reliance on primary data

30 references are cited for over 500 botanicals; most are secondary sources of information

Primary sources are used, including foreign language articles

Use of nonhuman data

Cannot be determined due to limited use of primary data

Human data primarily, although animal data are used on occasion

Description of limitations

Limitations of primary data for specific ingredients are generally not described, authors classify some botanicals as “Insufficient Data for Classification”

Limitations regarding studies used and the review were well described

Description of literature search strategy

Not described

Not described

Use of current literature

Published in 1997; secondary sources are mostly late 1980s to early 1990s

The ULs have been cited published from 1997 to 2004 in groups of nutrients; at the time of their publication, the authors considered the most recent literature; when and if they will be updated has not been determined

Starting assumptions/ appearance of impartiality

Not possible to discern due to reliance on secondary sources

Caution regarding excess intakes is given when no UL is provided

Use of peer review

Reviewers are listed in text

External peer reviewers were used and are listed in the report

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

Some different preparations, including different plant parts, are considered (e.g., cooked/raw, stems/leaves)

Focuses on nutrients present in foods or as concentrates, some of which may be various structural forms; when UL relates to one or more specific forms, discussed in text which forms and why

Description of consumption levels considered

For some substances, a “common therapeutic dose” is included, so safety conclusions are assumed to be based on these ingestion levels; however, many substances lack

Detailed description included on amounts consumed; how the amount ingested will impact the safety is considered, as the purpose is to derive a UL

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52
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)