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

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. "Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral." 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

Subject/Supplement

Adverse Effectsc and Related Findings

Concomitant use of botanicals: numerous

No elevations in liver function tests that would have indicated liver damage and (Heron and Yarnell, 2001)

Female (Heron’s patient no. 5)

Multiherb tincture containing 10% chaparral, ≤ 215 mL taken intermittently over 14 mo; proposed as treatment for recurrent dental infections

No elevations in liver function tests that would have indicated liver damage and (Heron and Yarnell, 2001)

Multiherb tincture containing chaparral, ≤ 30 mL ingested

No elevations in liver function tests that would have indicated liver damage and Heron and Yarnell, 2001)

c The clinical cases are arranged in decreasing order of apparent severity of the adverse effects.

d In the initial extraction, fresh (not dried) leaves and flowers of Larrea tridentata were lightly ground in ethanol:water (90:10) at 1:2.5 (w/v). (Heron and Yarnell, 2001).

e One other case report involving cancer exists (Smith et al., 1994), but it was omitted from this table for the following reasons. The cause and effect relationship between the subject’s intake of chaparral and the development of cancer was not well documented. The subject (a 56-year-old female) used chaparral tea (3–4 cups/d) for 3 mo during the 1.5-y period prior to the diagnosis of cystic renal cell carcinoma. The subject also used taheebo tea (5–6 cups/d) for 6 mo almost 20 y earlier. Taheebo tea is reported to contain quinones. The date of the onset of the malignancy is unknown. In this report the correlation between the subject’s cancer and the consumption of chaparral tea seems to have been made on the basis of the known effects of nordihydroguaiaretic acid (the major lignan in chaparral) in causing multiple renal cysts in rats. Thus there is no evidence that the subject’s renal cancer was the result of consumption of chaparral.

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435
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)