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

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Dietary Supplements: A Framework for Evaluating Safety

THE NATIONAL ACADEMIES PRESS
500 Fifth STREET, N.W. Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This study was supported by Contract Number 223-00-2458 between the National Academy of Sciences and the Food and Drug Administration. Additional support came from Institute of Medicine internal funds. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.

Library of Congress Cataloging-in-Publication Data

Dietary supplements : a framework for evaluating safety / Committee on the Framework for Evaluating the Safety of Dietary Supplements, Food and Nutrition Board [and] Board on Life Sciences.

p. ; cm.

Includes bibliographical references and index.

ISBN 0-309-09110-1 (hardcover)

1. Dietary supplements—Evaluation. 2. Dietary supplements—Toxicology.

[DNLM: 1. United States. Food and Drug Administration. 2. Dietary Supplements—standards—United States. 3. Safety—United States. 4. Government Regulation—United States. 5. Product Surveillance, Postmarketing—methods—United States. QU 145.5 D5639 2004] I. Committee on the Framework for Evaluating the Safety of Dietary Supplements.

RM258.5.D543 2004

613.2′8—dc22

2004022339

Additional copies of this report are available from the
National Academies Press,
500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2005 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

Cover photo of red ginger taken by Dr. Aniko Solyom, University of Arizona.

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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)