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Evolution of Evidence for Selectect Nutrient and Disease Relationships I.. ...~. .Y ~..~ .? Committee on Examination of the Evolving Science for Dietary Supplements Food and Nutrition Board INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 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. Support for this project was provided by the Food and Drug Administration, U.S. Department of Health and Human Services. The views presented in this report are those of the Institute of Medicine Committee on Examination of the Evolving Science for Dietary Supplements and are not necessarily those of the funding agency. International Standard Book Number: 0-309-08308-7. Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, D.C. 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP's home page at www.nap.edu. The full text of this report is available at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2002 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Xnowi7~ is not enough; we must apply. Fibbing is not enough; we must To. " Goethe ~ red ~ \ INSTITUTE OF MEDICINE Shaping the Future for Health

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National Academy of Sciences National Academy of Engineering institute of Medicine National Research Council The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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COMMITTEE ON EXAMINATION OF THE EVOLVING SCIENCE FOR DIETARY SUPPLEMENTS NORMAN I. KRINSKY (Chair), Department of Biochemistry, Tufts University School of Medicine, Boston, Massachusetts LAWRENCE J. APPEL, Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University School of Medicine, Baltimore, Maryland STEPHANIE A. ATKINSON, Department of Pediatrics, Faculty of Health Sciences, McMaster University, Hamilton, Ontario LYNN B. BAILEY, Department of Food Science and Human Nutrition, University of Florida, Gainesville SUSAN TAYLOR MAYNE, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, Connecticut PAUL D. STOLLEY, Department of Epidemiology and Preventive Medicine, University of Maryland at Baltimore School of Medicine JUDITH R. TURNLUND, U.S. Depa~l~ent of Agriculture Western Human Nutrition Research Center, University of California, Davis Staff LINDA D. MEYERS, Study Director KIMBERLY F. STITZEL, Research Associate JAIME LANIER, Project Assistant (until May 2001) PETER T. KEO, Project Assistant (May to December 2001) GEORGE YORK, Administrative Assistant (from January 2002) GAIL E. SPEARS, Technical Editor v

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FOOD AND NUTRITION BOARD CUTBERTO GARZA (Chair), Division of Nutritional Sciences, Cornell University, Ithaca, New York ROBERT M. RUSSELL ~ Vice Chair), Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts VIRGINIA A. STALLINGS (Vice Chair), Division of Gastroenterology and Nutrition, The Children's Hospital of Philadelphia, Pennsylvania LARRY R. BEUCHAT, Center for Food Safety and Quality Enhancement, University of Georgia, Griffin BENJAMIN CABALLERO, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland ROBERT J. COUSINS, Center for Nutritional Sciences, University of Florida, Gainesville SHIRIKI KUMANYIKA, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia LYNN PARKER, Child Nutrition Programs and Nutrition Policy, Food Research and Action Center, Washington, D.C. ROSS L. PRENTICE, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington A. CATHARINE ROSS, Department of Nutrition, The Pennsylvania State University, University Park BARBARA O. SCHNEEMAN, Department of Nutrition, University of California, Davis ROBERT E. SMITH, R.E. Smith Consulting, Inc., Newport, Vermont STEVE L. TAYLOR, Food Processing Center, University of Nebraska, Lincoln CATHERINE E. WOTEKI, College of Agriculture, Iowa State University, Ames BARRY L. ZOUMAS, Department of Agricultural Economics and Rural Sociology, The Pennsylvania State University, University Park Staff ALLISON A. YATES, Director LINDA D. MEYERS, Deputy Director GAIL E. SPEARS, Administrative Assistant GERRI KENNEDO, Administrative Assistant GARY WALKER, Financial Associate V1

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Baas 1 ~ __== Acknowledgments The Committee on Examination of the Evolving Science for Dietary Supplements was aided in its challenging task by the invaluable contributions of a number of individuals. Elizabeth A. Yetley, the Food and Drug Administra- tion's Project Officer, met with the committee early in its deliberations. We appreciated her clear presentation about the committee's task. The committee was assisted by the very able staff work of Linda D. Meyers, study director; Kimberly Stitzel, research associate; and Jamie Lanier, Peter Keo, and George York, project assistants. The committee is also indebted to Allison Yates, Director of the Food and Nutrition Board, for providing valuable advice and perspective. We also thank Gail Spears for sound editorial advice, Gary Walker for financial management, and Paige Baldwin and other members of the Institute of Medicine's Office of Reports and Communication for skill in the production of the report. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's (NRC) Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of . . V11

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~ . . V111 AC~OWLEDGMENTS the deliberative process. We wish to thank the following individuals for their review of this report: William Harlan, M.D., National Institutes of Health Laurence N. Kolonel, M.D., Ph.D., Cancer Research Center of Hawaii Lewis H. Kuller, M.D., University of Pittsburgh Eric Rimm, Sc.D., Harvard School of Public Health Irwin Rosenberg, M.D., Tufts University Christopher Sempos, Ph.D., State University of New York at Buffalo Norman H. Sleep, Ph.D., Stanford University Joseph V. Smith, Ph.D., The University of Chicago Martha Vaughan, M.D., National Institutes of Health Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Maiden C. Nesheim, Ph.D., Cornell University, appointed by the Institute of Medicine, and Gilbert S. Omenn, M.D., Ph.D., University of Michigan, appointed by the NRC's Report Review Committee. The coordinator and monitor were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. As chair of the panel, I want to thank my fellow committee members for their commitment to the work of the committee under a rather demanding time schedule. Their quick and constructive responses to the many drafts of the report made meeting the deadline possible. Norman I. Krinsky Committee Chair

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Contents EXECUTIVE SUMMARY 1 BACKGROUND 9 The Committee and Its Charge, 10 The Report, 11 The Committee's Approach, 11 Selection of Case Studies, 13 Examination of Evidence, 14 2 CASE STUDIES Increased Confidence in Relationship, 19 Decreased Confidence in Relationship, 28 Unchanged Confidence in Relationship, 33 Relationship Discussed Only in a Dietary Reference Intake Report, 44 FINDINGS Findings, 5 1 Concluding Remarks, 56 4 REFERENCES 19 51 APPENDIXES A Tables from the Dietary Reference Intake Reports, 69 B Committee Member Biographical Sketches, 85 1X

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