National Academy of Sciences | 150 Year Anniversary

Questions? Call 800-624-6242

| Items in cart [0]

The National Academies Press

HARDBACK
price:$59.95
add to cart

Rights & Permissions

topleft topright

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

Citation Manager

. "3 The Framework." Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press, 2005.

Please select a format:

BibTeX EndNote RefMan


Page
111
bottomleft bottomright

The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy.


Dietary Supplements: A Framework for Evaluating Safety

 

It has a history of use as a food in a preparation and method similar to its current use

not in a genus known as a food plant

OR

In a plant family that is known to contain toxic plants, and in a genus that may have a history of food use, but supplement is either a concentrated extract or from a different plant part than is ingested as a food

 

Chemical structure

Structurally similar to, or likely contains, a chemical compound known to be toxic to humans or animals when ingested in high doses

Supplement contains chemical constituent known to be toxic to humans or animals

Supplement contains chemical constituent known to be toxic at very low doses to humans

Endogenous substances or mimetics of endogenous substances

May result in tissue concentrations that would be expected to cause biological effects (either because homeostasis is disrupted or because the substance has potent biological activities), but the seriousness of the biological effect is not definite

Results seen in tissue concentrations that would be expected to cause biological effects (either because homeostasis is disrupted or because the substance has potent biological activities), but the seriousness of the biological effect is not definite

Results seen in tissue concentrations that would be expected to cause biological effects (either because homeostasis is disrupted or because the substance has potent biological activities) that are considered serious

Page
111
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)