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

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. "1 Introduction and Background." 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

Cardello HMAB, Da Silva MAPA, Damasio MH. 1999. Measurement of the relative sweetness of stevia extract, aspartame and cyclamate/saccharin blend as compared to sucrose at different concentrations. Plant Foods Human Nutr 54:119–130.

CDER (Center for Drug Evaluation and Research). 2002. The Patent Medicine Menace. Online. Food and Drug Administration. Available at http://www.fda.gov/cder/about/history/gallery/galleryintro.htm. Accessed March 4, 2002.

CDSL (Commission on Dietary Supplement Labels). 1997. Report of the Commission on Dietary Supplement Labels. Washington, DC: U.S. Government Printing Office.

CFSAN. 2004. Androstenedione Warning Letters. Online. Food and Drug Administration. Available at http://www.cfsan.fda.gov/~dms/andrlist.html. Accessed March 15, 2004.

Costello RB, Grumpstrup-Scott J. 2000. Zinc: What role might supplements play? J Am Diet Assoc 100:371–376.


Dwyer JT, Garceau AO, Evans M, Li D, Lytle L, Hoelscher D, Nickas TA, Zive M. 2001. Do adolescent vitamin-mineral supplement users have better nutrient intakes than nonusers? Observations from the CATCH tracking study. J Am Diet Assoc 101:1340–1346.


East Earth Herb. 2000. East Earth Herb Recalls Jade Pharmacy Brand Meridian Circulation and Quell Fire Because of Possible Health Risk. Online. November 21. News release. Available at http://www.fda.gov/oc/po/firmrecalls/eastearth11_00.html. Accessed March 3, 2002.


FDA (Food and Drug Administration). 1941. Regulations for the enforcement of the Federal Food, Drug, and Cosmetic Act. Fed Regis 6:5921–5926.

FDA. 1966. Dietary supplements and vitamin and mineral-fortified foods. Fed Regis 31: 15730–15736.

FDA. 1973. Definitions and standards of identity for food for special dietary use. Dietary supplements of vitamins and minerals. Fed Regis 38:20730.

FDA. 1979. Vitamin and mineral drug products for over-the-counter human use. Fed Regis 44:16125–16200.

FDA. 1981. The story of the laws behind the labels part II: 1938—The Federal Food, Drug, and Cosmetic Act. FDA Consumer. Online. Available at http://vm.cfsan.fda.gov/~lrd/histor1a.html. Accessed June 6, 2002.

FDA. 1987. Food labeling; Public health messages and label statements. Proposed rules. Fed Regis 52:28843–28849.

FDA. 1993. Regulation of dietary supplements. Advanced Notice of Proposed Rulemaking 21, CFR Chapter 1. Fed Regis 58:33690.

FDA. 1995. 75-Day Notification for Stevia from Sunrider Corporation, Docket 95S-0316. Online. Available at http://www.fda.gov/ohrms/dockets/dockets/95s0316/m000002.pdf. Accessed March 24, 2004.

FDA. 1997. Substances generally recognized as safe, Proposed rule. Fed Regis 62:18937–18964.

FDA. 2000. FDA Warns Against Consuming Dietary Supplements Containing Tiratricol. Online. FDA Talk Paper. November 21. Available at http://www.fda.gov/bbs/topics/ANSWERS/ANS0105.html. Accessed March 8, 2002.

FDA. 2001a. Information Paper on L-Tryptophan and 5-Hydroxy-L-tryptophan. Online. Available at http://vm.cfsan.fda.gov/~dms/ds-tryp1.html. Accessed March 26, 2004.

FDA. 2001b. Premarket notice concerning bioengineered foods. Fed Regis 66:4706–4738.

FDA. 2002. FDA Backgrounder. Milestones in U.S. Food and Drug Law History. Online. Available at http://www.fda.gov/opacom/backgrounders/miles.html. Accessed March 13, 2004.

FDA. 2003. Current good manufacturing practices in manufacturing, packing, or holding dietary ingredients and dietary supplements. Proposed rule. Fed Regis 68:12157–12263.

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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)