Dietary Supplements: A Framework for Evaluating Safety

527 Pages·2004·12.33 MB·English

by  National Research Council, Committee on the Framework for Evaluating the Safety of the Dietary Supplements

Committee on the Framework for Evaluating the
Safety of Dietary Supplements
Food and Nutrition Board
Board on Life Sciences
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 Govern-
ing Board of the National Research Council, whose members are drawn from the
councils of the National Academy of Sciences, the National Academy of Engineer-
ing, and the Institute of Medicine. The members of the committee responsible for
the report were chosen for their special competences and with regard for appropri-
ate 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
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Cover photo of red ginger taken by Dr. Aniko Solyom, University of Arizona.
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COMMITTEE ON THE FRAMEWORK FOR EVALUATING THE
SAFETY OF DIETARY SUPPLEMENTS
BARBARA O. SCHNEEMAN (Chair), Departments of Nutrition and
Food Science, Division of Clinical Nutrition and Metabolism, and
Office of University Outreach, University of California, Davis
DANIEL L. AZARNOFF, D.L. Azarnoff Associates and Clinical/
Regulatory Affairs, Cellegy Pharmaceuticals, South San Francisco,
California
CINDY LYNN CHRISTIANSEN, Center for Health Quality, Outcomes,
and Economic Research, Bedford V.A. Hospital, and Boston
University School of Public Health, Massachusetts
ALICE M. CLARK, Office of Research and Sponsored Programs,
University of Mississippi, Oxford
NORMAN R. FARNSWORTH, Department of Medicinal Chemistry
and Pharmacognosy, University of Illinois at Chicago
TED GANSLER, Medical Information Strategy, American Cancer
Society, Atlanta, Georgia
JAMES E. GIBSON, Department of Pharmacology and Toxicology,
The Brody School of Medicine at East Carolina University,
North Carolina
STEPHEN A. GOLDMAN, Stephen A. Goldman Consulting Services,
LLC, Morris Plains, New Jersey
PHILIP S. GUZELIAN, Department of Medicine, University of Colorado
Health Sciences Center, Denver
ELIZABETH JEFFERY, Department of Food Science and Human
Nutrition, University of Illinois at Urbana-Champaign
LOREN D. KOLLER, Loren Koller and Associates, LLC, Corvallis,
Oregon
JOSEPH LAU, Institute for Clinical Research and Health Policy Studies,
Tufts New England Medical Center, Boston, Massachusetts
RUSSELL J. MOLYNEUX, USDA Western Regional Research Center,
Albany, California
SUSAN S. PERCIVAL, Department of Food Science and Human
Nutrition, University of Florida, Gainesville
CHERYL L. ROCK, Department of Family and Preventive Medicine,
University of California, San Diego, La Jolla
JERROLD M. WARD, Division of Intramural Research, National
Institute of Allergy and Infectious Diseases, National Institutes of
Health, Bethesda, Maryland
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Consultants
LEWIS A. GROSSMAN, Washington College of Law, American
University, Washington, D.C.
JOSEPH RODRICKS, ENVIRON International, Arlington, Virginia
Staff
ALLISON A. YATES, Study Director
MARILEE SHELTON-DAVENPORT, Program Officer
JANICE OKITA, Program Officer
CRYSTAL RASNAKE, Research Assistant
SANAIT TESFAGIORGIS, Senior Project Assistant
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PROTOTYPE MONOGRAPHS
Chaparral Consultants
CYNTHIA K. ARON, University of Massachusetts Memorial Medical
Center, Worcester
MARILYN BARRET, Pharmacognosy Consulting Services, San Carlos,
California
CARL K. WINTER, Department of Food Science and Technology,
University of California, Davis
Chromium Picolinate Consultants
AARON BARCHOWSKY, Department of Pharmacology and
Toxicology, Dartmouth Medical School, Hanover, New Hampshire
MAX COSTA, Department of Environmental Medicine, New York
University Medical School, New York City
JIM K. LIU, College of Pharmacy, University of New Mexico,
Albuquerque
STEVEN R. PATIERNO, Department of Pharmacology, George
Washington University School of Medicine, Washington, D.C.
STEVEN R. SMITH, Pennington Biomedical Research Center, Louisiana
State University, Baton Rouge
BARBARA STOECKER, Department of Nutritional Sciences, Oklahoma
State University, Stillwater
Glucosamine Consultants
H.B. “SKIP” MATTHEWS, Consultant, Hertford, North Carolina
TIMOTHY EDWARD McALINDON, Boston University School of
Medicine, Massachusetts
DONALD ALLAN McCLAIN, Division of Endocrinology and
Metabolism, University of Utah School of Medicine, Salt Lake City
Melatonin Consultants
ANITA CAVALLO, Cincinnati Children’s Hospital Medical Center,
Cincinnati, Ohio
STANLEY T. OMAYE, Department of Nutrition, University of Nevada,
Reno
PHYLLIS C. ZEE, Neurobiology and Physiology, Northwestern
University Institute for Neuroscience, Chicago, Illinois
vi
Saw Palmetto Consultants
SHUTSUNG LIAO, Ben May Institute, University of Chicago, Chicago,
Illinois
LEONARD S. MARKS, Urological Sciences Research Foundation, Culver
City, California
STEPHEN H. SAFE, Department of Veterinary Physiology and
Pharmacology, Texas A&M University, College Station
Shark Cartilage Consultants
SAMUEL M. COHEN, Department of Pathology and Microbiology,
University of Nebraska Medical Center, Omaha
SUSAN E. CRAWFORD, Department of Pathology, Northwestern
University Medical School, Chicago, Illinois
JOSEPH A. SCIMECA, General Mills, Inc., St. Louis Park, Minnesota
KIN-PING WONG, College of Science and Mathematics, California State
University, Fresno
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FOOD AND NUTRITION BOARD
CATHERINE E. WOTEKI (Chair), College of Agriculture, Iowa State
University, Ames
ROBERT M. RUSSELL (Vice Chair), Jean Mayer USDA Human
Nutrition Research Center on Aging, Tufts University, Boston,
Massachusetts
LARRY R. BEUCHAT, Center for Food Safety, University of Georgia,
Griffin
SUSAN FERENC, SAF*Risk, LC, Madison, Wisconsin
NANCY F. KREBS, Department of Pediatrics, University of Colorado
Health Sciences Center, Denver
SHIRIKI KUMANYIKA, Center for Clinical Epidemiology and
Biostatistics, University of Pennsylvania School of Medicine,
Philadelphia
REYNALDO MARTORELL, Rollins School of Public Health, Emory
University, Atlanta, Georgia
LYNN PARKER, Child Nutrition Programs and Nutrition Policy, Food
Research and Action Center, Washington, D.C.
BARBARA O. SCHNEEMAN, Department of Nutrition, University of
California, Davis
NICHOLAS J. SCHORK, Polymorphism Research Laboratory, University
of California, San Diego
JOHN W. SUTTIE, Department of Biochemistry, University of
Wisconsin, Madison
STEVE L. TAYLOR, Department of Food Science and Technology and
Food Processing Center, University of Nebraska, Lincoln
BARRY L. ZOUMAS, Department of Agricultural Economics and Rural
Sociology, Pennsylvania State University, University Park
Staff
LINDA D. MEYERS, Director starting October 2003
ALLISON A. YATES, Director through September 2003
GERALDINE KENNEDO, Administrative Assistant
GAIL SPEARS, Staff Editor
ELISABETH RIMAUD, Financial Associate
viii
BOARD ON LIFE SCIENCES
COREY S. GOODMAN (Chair), Department of Molecular and Cell
Biology, University of California, Berkeley
RUTH BERKELMAN, Rollins School of Public Health, Emory
University, Atlanta, Georgia
R. ALTA CHARO, Law and Medical Ethics, University of Wisconsin,
Madison
JOANNE CHORY, The Salk Institute for Biological Studies, La Jolla,
California
JEFFREY L. DANGL, Department of Biology, University of North
Carolina, Chapel Hill
PAUL EHRLICH, Department of Biological Sciences, Stanford
University, Palo Alto, California
JAMES M. GENTILE, Natural Science Division, Hope College, Holland,
Michigan
LINDA E. GREER, Natural Resources Defense Council, Washington, D.C.
ED HARLOW, Department of Biological Chemistry and Molecular
Pharmacology, Harvard Medical School, Boston, Massachusetts
DAVID HILLIS, Institute for Cellular and Molecular Biology, University
of Texas, Austin
KENNETH F. KELLER, Humphrey Institute of Public Affairs, University
of Minnesota, Minneapolis
RANDALL MURCH, Institute for Defense Analyses, Alexandria,
Virginia
ROBERT T. PAINE, Department of Zoology, University of Washington,
Seattle
GREGORY A. PETSKO, Rosenstiel Basic Medical Sciences Research
Center, Brandeis University, Waltham, Massachusetts
STUART L. PIMM, Nicholas School of Environmental and Earth
Sciences, Duke University, Durham, North Carolina
BARBARA A. SCHAAL, Department of Biology, Washington University,
St. Louis, Missouri
JAMES TIEDJE, Center for Microbial Ecology, Michigan State
University, East Lansing
KEITH YAMAMOTO, Department of Cellular and Molecular
Pharmacology, University of California, San Francisco
Staff
FRANCES SHARPLES, Director
MARILEE SHELTON-DAVENPORT, Program Officer
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