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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

 

products sold in the United States

Sponsorship by trade association organization

Starting assumptions of safety; lack of information appears to be interpreted as safety

Preclinical safety data section may be useful for individual botanicals

of supplements that are covered; describes a wide range of dietary

A useful cross-reference to brand names is included

The continuum of safety classifications considered is helpful, as is the attention paid to formulation, plant part, and species

 

Resource

Considerations

Natural Standard (Natural Standard, 2003) (Reviewed Black Cohosh)

Physican’s Desk Reference (PDR) for Herbal Medicines (Medical Economics, 1998, 2000)

Type of organization responsible for resource

For-profit, not supported by any interest group, professional organization, or pharmaceutical manufacturer

For-profit organization

Substances reviewed

Covers alternative therapies and complementary medicines, including nutrient and nonnutrient dietary supplements

Over 700 botanicals

Product/endpoint

Online monograph

Book of brief monographs

Focus on safety/risk

Safety and efficacy are considered

Both safety and efficacy are considered

Reliance on primary data

Mostly primary sources, some abstracts, including foreign language articles

Primary sources are cited, including foreign language sources

Use of nonhuman data

Mostly human data, some in vitro data and a limited number of animal studies are considered

Mostly human data; however, some animal and in vitro data are considered

Description of limitations

Limitations are described

Limitations are somewhat described

Description of literature search strategy

Described thoroughly

Search strategy is not described; many monographs appear to be based upon the Commission E translation

Page
59
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)