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Dietary Supplements: A Framework for Evaluating Safety

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Dietary Supplements

A Framework for Evaluating Safety(2005)
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The growing consumer interest in health and fitness has expanded the market for a wide range of products, from yoga mats to the multiple dietary supplements now on the market. Supplements are popular, but are they safe? Many dietary supplements are probably safe when used as recommended. However, since 1994 when Congress decided that they should be regulated as if they were foods, they are assumed to be safe unless the Food and Drug Administration can demonstrate that they pose a significant risk to the consumer. But there are many types of products that qualify as dietary supplements, and the distinctions can become muddled and vague. Manufacturers are not legally required to provide specific information about safety before marketing their products. And the sales of supplements have been steadily increasing—all together, the various types now bring in almost $16 billion per year. Given these confounding factors, what kind of information can the Food and Drug Administration use to effectively regulate dietary supplements? This book provides a framework for evaluating dietary supplement safety and protecting the health of consumers.


Suggested Citation

Institute of Medicine and National Research Council. 2005. Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press.

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Publication Info

526 pages |6 x 9
ISBN: 978-0-309-09110-7

Table of Contents

skim chapter
Front Matter i-xx
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

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