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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

TABLE A Chaparral: Individual Components

Substance

Structure

Safety Issues

Lignans, nordihydroguaiaretic acid (NDGA), and other substituted guaiaretic acid derivatives

NDGA (Duisberg et al., 1949; Waller and Gisvold, 1945)

Present in all parts of Larrea tridentata, including leaves, stems and twigs at 5–15% of the dry leaf weight (Mabry et al., 1977)

 

Animal studies: see Table E for safety issues from animal studies with NDGA

In vitro study: see Table F-2 for safety issues from in vitro studies with NDGA

Dihydroguaiaretic acid (Obermeyer et al., 1995)

Partially demethylated dihydroguaiaretic acid is also present (Gisvold and Thaker, 1974)

 

In vitro study: weak cytotoxic activity (IC50 1–3 μg/mL) (Njoku et al., 1997)

In vitro study: weak cytotoxic activity (10 μg/mL) and (Gisvold and Thaker, 1974)

Guaiaretic acid (Obermeyer et al., 1995)

 

No data suggestive of toxicity are available

Secoisolariciresinol (Obermeyer et al., 1995)

Present in the stems of L. tridentata (Konno et al., 1990)

 

In vitro study: weak cytotoxic activity (IC50 0.6–8.3 μg/mL) (Shen et al., 1997); see Table F-2

Lignans, furanoid

Larreatricin (Konno et al., 1987)

Present in the stems of L. tridentata (Konno et al., 1990) in trace amounts (0.001% of dry leaf weight)

 

No data suggestive of toxicity are available

4-epi-Larreatricin (Konno et al., 1987)

Present in the leaves, twigs and stems of L. tridentata (Konno et al., 1990) in trace amounts (up to 0.0003% of dry leaf weight)

 

No data suggestive of toxicity are available

Page
411
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)