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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

Vulvovaginitis in livestock

C

Caused by fungal contamination

Cholineesterase Inhibition

A

 

Gastritis, vasomotor collapse, coma, death

A

 

b Several species of these genera are common conventional food and/or condiment plants and are of little concern when consumed.

c Produced by endophytic fungi in some, but not all, cases.

d Class A concerns for Festuca stem from concerns about penitrem alkaloids and ergot alkaloids produced by fungal contamination, which can occur fairly frequently depending on weather conditions. Even if fungal contamination is not present, there are concerns when the plants grow in high-selenium soils, warranting at least a class B classification.

may vary and thus be less problematic in some plant parts, but the assumption should be that all parts of a plant containing toxins pose a risk unless there is credible evidence suggesting that dangerous levels of toxins are not present in the part marketed as a dietary supplement. In this case, selection of plant material at a specific growth stage to avoid incorporation of potentially toxic plant parts is desirable.

Cultivation and Other Conditions

In addition to concentration of toxic compounds in particular plant parts, levels of toxins in plants may also be influenced by growth stage, time of collection, environmental stress, herbivory, and a multitude of other factors (Fong, 2002). Blending of plant material from a number of locations will tend to dilute toxin levels that are higher in some plants if other plants are lower in toxin levels. However, in the absence of comprehensive studies, it is not possible to delineate precisely the overall influence of such conditions on constituent levels, although their role must be recognized in evaluating the safety of dietary supplements. When sporadic adverse incidents occur in association with a botanical supplement ingredient with no previous indication of risk, it may well be possible that environmental changes have resulted in an increase in levels of toxic constituents. If a plant’s content of a hazardous phytochemical varies significantly with environ-

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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)