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

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. "6 Categories of Scientific Evidence--Information About Related Substances." 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

Observed or Predicted Toxicity

Classa

Other Comments

Gastritis, vasoconstriction, death

B

Large amounts in livestock

Cholinesterase inhibition, death

A

 

Extreme irritation on inhalation of root powder

B

 

Cholinomimetic

A

 

Abortifacient

B

Mainly in livestock

Gastroenteritis, catharsis, conjunctivitis

A

 

Cardiotoxic

A

 

Gastroenteritis, death

A

 

Cardiac and respiratory failure, death

A

 

Nephrotoxic

A

 

Carcinogenic

A

The fronds (fiddle heads) are processed (salting) and are safely eaten. All toxicities reported in livestock are from unprocessed fronds

Gastroenteritis, death

A

Mainly in large doses in livestock

Indigestion, depression, death

B

Mainly in livestock

Convulsant

A

All parts

Blindness

A

Mainly in livestock

Hemorrhagic, circulatory system

A

Only seeds are toxic

Hemorrhagic, circulatory system

A

 

Incoordination, gastroenteritis

C

Large amounts in livestock

Indigestion, Depression, death

C

Mainly in livestock

Cardiac and respiratory failure, death

A

 

Coma

A

Rhizomes

Gastroenteritis, coma, death

B

 

Indigestion, depression, death

B

Mainly in large amounts in livestock

Hypotension

B

Seeds and leaves

Carcinogenic

A

Bark, essential oils

Cardiotoxic, death

A

 

Page
197
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)