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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

literature cited is drawn from primary research sources, followed by secondary sources as appropriate.

VII. LITERATURE CITED

ACS (American Cancer Society). 1970. Unproven Methods of Cancer Treatment: Chaparral Tea. New York: ACS.

Adlercreutz H, Bannwart C, Wahala K, Makela T, Brunow G, Hase T, Arosemena PJ, Kellis JT Jr, Vickery LE. 1993. Inhibition of human aromatase by mammalian lignans and isoflavonoid phytoestrogens. J Steroid Biochem Mol Biol 44:147–153.

Afifi FU, Al-Khalil S, Abdul-Haq BK, Mahasneh A, Al-Eisawi DM, Sharaf M, Wong LK, Schiff PL Jr. 1991. Antifungal flavonoids from Varthemia iphionoides. Phytother Res 5:173–175.

Agarwal R, Wang ZY, Bik DP, Mukhtar H. 1991. Nordihydroguaiaretic acid, an inhibitor of lipoxygenase, also inhibits cytochrome P-450-mediated monooxygenase activity in rat epidermal and hepatic microsomes. Drug Metab Dispos 19:620–624.

AHPA (American Herbal Products Association). 2002. Code of Ethics and Business Conduct. Silver Spring, MD: AHPA.

Alderman S, Kailas S, Goldfarb S, Singaram C, Malone DG. 1994. Cholestatic hepatitis after ingestion of chaparral leaf: Confirmation by endoscopic retrograde cholangio-pancreatography and liver biopsy. J Clin Gastroenterol 19:242–247.

Andersson BS, Rundgren M, Nelson SD, Harder S. 1990. N-acetyl-p-benzoquinone imineinduced changes in the energy metabolism in hepatocytes. Chem Biol Interact 75:201–211.

Anesini C, Boccio J, Cremaschi G, Genaro A, Zubillaga M, Borda LS, Borda ES. 1997. In vivo antitumoural activity and acute toxicity study of Larrea divaricata Cav. extract. Phytother Res 11:521–523.

Ashby J. 2002. Scientific issues associated with the validation of in vitro and in vivo methods for assessing endocrine disrupting chemicals. Toxicology 181–182:389–397.


Banskota AH, Tezuka Y, Tran KQ, Tanaka K, Saiki I, Kadota S. 2000. Methyl quadrangularates A-D and related triterpenes from Combretum quadrangulare. Chem Pharm Bull (Tokyo) 48:496–504.

Batchelor WB, Heathcote J, Wanless IR. 1995. Chaparral-induced hepatic injury. Am J Gastroenterol 90:831–833.

Bernhard HO, Thiele K. 1981. Additional flavonoids from the leaves of Larrea tridentata. Planta Med 41:100–103.

Bhuvaneswaran C, Dakshinamurti K. 1972. Inhibition of electron and energy transfer in rat liver mitochondria by nordihydroguaiaretic acid. Biochemistry (Mosc) 11:85–91.

Biswal SS, Datta K, Shaw SD, Feng X, Robertson JD, Kehrer JP. 2000. Glutathione oxidation and mitochondrial depolarization as mechanisms of nordihydroguaiaretic acid-induced apoptosis in lipoxy-genase-deficient FL5.12 cells. Toxicol Sci 53:77–83.

Blalock JE, Archer DL, Johnson HM. 1981. Anticellular and immunosuppressive activities of food-borne phenolic compounds. Proc Soc Exp Biol Med 167:391–393.

Blumenthal M. 1993. Herb industry and FDA issue chaparral warning. Herbalgram 28:38–39.

Blumenthal M. ed. 1998. Therapeutic Guide to Herbal Medicines. The Complete German Commission E Monographs. Austin, TX: American Botanical Council.

Bohnstedt CFMTJ. 1979. The volatile constituents of the genus Larrea (Zygophyllaceae). Rev Latinoamer Quim 10:128–131.

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403
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)