USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL

Committee on Dietary Supplement Use by Military Personnel

Food and Nutrition Board

M.R.C. Greenwood and Maria Oria, Editors

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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Committee on Dietary Supplement Use by Military Personnel Food and Nutrition Board M.R.C. Greenwood and Maria Oria, Editors

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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 No. W911QY-06-C-0095 between the National Academy of Sciences and the Department of Defense; Contract No. W81XWH-06-10787 between the National Academy of Sciences and the Depart- ment of the Army; Contract No. N01-OD-4-2139 TO #177 between the National Academy of Sciences and the National Institutes of Health, U.S. Department of Health and Human Services; Contract No. HHSF223200710832P between the National Academy of Sciences and the Food and Drug Administration, U.S. Depart- ment of Health and Human Services; and Letter of Agreement No. OFED-7819 between the National Academy of Sciences and Samueli Institute. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-11617-6 International Standard Book Number-10: 0-309-11617-1 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 2008 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 ad- opted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2008. Use of dietary supplements by military personnel. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health.

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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 Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone 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 en- gineers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences 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 Coun- cil is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON DIETARY SUPPLEMENT USE BY MILITARY PERSONNEL M.R.C. GREENWOOD (Chair), University of California, Davis CHERYL ANDERSON, Department of Epidemiology, Johns Hopkins University, Baltimore, MD BRUCE BISTRIAN, Harvard Medical School, Boston, MA JOHN W. ERDMAN, Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign WILLIAM C. FRANKE, Center for Advanced Food Technology, Rutgers, The State University of New Jersey, New Brunswick ELIZABETH JEFFERY, Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign ROBIN B. KANAREK, Department of Psychology, Tufts University, Medford, MA CARL L. KEEN, Department of Nutrition, University of California, Davis GAIL B. MAHADY, Clinical Pharmacognosy Laboratories, College of Pharmacy, University of Illinois at Chicago SANFORD A. MILLER, Center for Food, Nutrition, and Agriculture Policy, University of Maryland, College Park ESTHER F. MYERS, Research and Scientific Affairs, American Dietetic Association, Chicago, IL JANET WALBERG RANKIN, Department of Human Nutrition, Foods, and Exercise, Virginia Polytechnic Institute and State University, Blacksburg Consultant DAVID F. DINGES, Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia Staff MARIA P. ORIA, Study Director SHANNON L. WISHAM, Research Associate (until April 2008) ALICE VOROSMARTI, Research Associate (from April 2008) SANDRA AMAMOO-KAKRA, Program Associate HILARY RAY, Editor 

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STANDING COMMITTEE ON MILITARY NUTRITION RESEARCH* JOHN W. ERDMAN (Chair), Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign ELDON WAYNE ASKEW, Division of Nutrition, University of Utah, Salt Lake City BRUCE R. BISTRIAN, Harvard Medical School, Boston, MA JOSEPH G. CANNON, School of Allied Health Sciences Health Research, Medical College of Georgia, Augusta JOHANNA DWYER, Frances Stern Nutrition Center, Tufts University, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD WILLIAM C. FRANKE, Center for Advanced Food Technology, Rutgers, The State University of New Jersey, New Brunswick RONALD GLASER, Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus ROBIN B. KANAREK, Department of Psychology, Tufts University, Medford, MA ESTHER F. MYERS, Research and Scientific Affairs, American Dietetic Association, Chicago, IL Staff MARIA P. ORIA, Study Director SANDRA AMAMOO-KAKRA, Program Associate *IOM standing committees do not review or approve individual reports and are not asked to endorse conclusions and recommendations. The responsibility for the content of the report rests with the authoring committee and the institution. i

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FOOD AND NUTRITION BOARD* DENNIS M. BIER (Chair), Children’s Nutrition Research Center, Houston, TX MICHAEL P. DOYLE (Vice Chair), Center for Food Safety, University of Georgia, Griffin DIANE BIRT, Department of Food Science and Human Nutrition, Iowa State University, Ames YVONNE BRONNER, School of Public Health and Policy, Morgan State University, Baltimore, MD FERGUS M. CLYDESDALE, Department of Food Science, University of Massachusetts, Amherst GORDON L. JENSEN, Department of Nutritional Sciences, Pennsylvania State University, University Park REYNALDO MARTORELL, Department of Global Health, Emory University, Atlanta, GA SUSAN T. MAYNE, Division of Chronic Disease Epidemiology, Yale University School of Medicine, New Haven, CT SANFORD A. MILLER, Center for Food, Nutrition, and Agriculture Policy, University of Maryland, College Park J. GLENN MORRIS, JR., Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore SUZANNE P. MURPHY, Cancer Research Center of Hawaii, University of Hawaii, Honolulu JOSE M. ORDOVAS, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA MARTIN A. PHILBERT, School of Public Health, University of Michigan, Ann Arbor JIM E. RIVIERE, Center for Chemical Toxicology Research and Pharmacokinetics, North Carolina State University, Raleigh REBECCA J. STOLTZFUS, Division of Nutritional Sciences, Cornell University, Ithaca, NY PATRICK J. STOVER, Division of Nutritional Sciences, Cornell University, Ithaca, NY WALTER C. WILLETT, Department of Nutrition, Harvard School of Public Health, Boston, MA Staff LINDA D. MEYERS, Director GERALDINE KENNEDO, Administrative Assistant ANTON L. BANDY, Financial Associate *IOM boards do not review or approve individual reports and are not asked to endorse conclusions and recommendations. The responsibility for the content of the report rests with the authoring committee and the institution. ii

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Reviewers 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 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 the deliberative process. We wish to thank the following individuals for their review of this report: ELDON WAYNE ASKEW, Division of Nutrition, University of Utah, Salt Lake City DIANE BIRT, Center for Research on Dietary Botanical Supplements, Department of Food Science and Human Nutrition, Iowa State University, Ames GRAHAM A. COLDITZ, Department of Surgery, Washington University School of Medicine, St. Louis, MO HARRY S. FONG, Department of Medicinal Chemistry and Pharmacognosy, Professor Emeritus, University of Illinois at Chicago DAVID W. KAUFMAN, Slone Epidemiology Center and School of Public Health, Boston University, MA RICK KINGSTON, SafetyCall™ International and College of Pharmacy, University of Minnesota, Bloomington ix

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x REVIEWERS MELINDA M. MANORE, Department of Nutrition, Oregon State University, Corvallis MOHSEN MEYDANI, Vascular Biology Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, and Dorothy R. Friedman School of Nutrition Science, Tufts University, Boston, MA SIMIN NIKBIN MEYDANI, Nutritional Immunology Laboratory, School of Nutrition Science and Policy and Sackler Graduate School, Tufts University, Boston, MA JOSEPH V. RODRICKS, Environ, Institute for Health Risk Sciences, Arlington VA A. P. SMITH, Centre for Occupational and Health Psychology, Cardiff University, Cardiff, UK JUDITH S. STERN, Department of Nutrition, University of California, Davis MATTHEW VUKOVICH, Applied Physiology Laboratory, Department of Health, Physical Education, and Recreation, South Dakota State University, Brookings THOMAS R. ZIEGLER, Clinical Research Center, Emory University Hospital, Atlanta, GA 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 JOHN C. BAILAR III, The University of Chicago, Professor Emeritus, and ROBERT J. COUSINS, Food Science and Human Nutrition Department, University of Florida. Appointed by the National Research Council and Institute of Medicine, they 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.

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Preface This report, titled Use of Dietary Supplements by Military Personnel, is the product of the work of an ad hoc committee under the auspices of the Standing Committee on Military Nutrition Research (CMNR). The CMNR, a standing committee of the Food and Nutrition Board (FNB), was established in 1982 to advise the U.S. Department of Defense (DoD) on the need for and conduct of nutrition research and related issues. This report was produced in response to a request by the Military Nutrition Division of the U.S. Army Research Institute of Environmental Medicine (USARIEM) to the Institute of Medicine (IOM) to convene a committee to review the use of dietary supplements by military personnel and recommend an approach to determine which dietary supplements need active management. Initial sponsors of the study were USARIEM, the U.S. Army Medical Research and Materiel Command, the Samueli Institute, and the National Institutes of Health Office of Dietary Supplements. Their representatives helped with the formulation of the specific questions in consultation with the CMNR. As the project was initiated, the U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition became a sponsor of the study. A 12-member committee was formed that had expertise in micronutri- ents, protein, energy balance and sports nutrition, gastroenterology, clinical medicine, food processing and technology, eating behavior and intake regu- lation, clinical nutrition, dietetics, and psychology. Dietary supplements are widely available through a rapidly expanding market of products that are commonly advertised as being beneficial for health, performance enhance- ment, and disease prevention. These claims may influence the use of dietary xi

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xii PREFACE supplements by military personnel, given the importance and frequent eval- uation of physical performance and health as criteria to join and remain in the military. The increase in use of these products has raised some concern regarding their overall and long-term efficacy and safety. The evaluation of such products is especially difficult since many contain multiple ingredients, have a changing composition over time, or are used intermittently at doses difficult to measure. Because of these difficulties, it may take a long time for the current system of voluntary adverse event reporting to detect problems. Although the vast majority of military personnel are assumed to be at the same general risk as the overall U.S. population, the specific requirements of some military personnel require that additional due diligence be exercised both with respect to possible benefits and to the possible risks when these products are used by military personnel in particular job classifications and/or environments. For special military subpopulations, relatively minor adverse effects could seriously affect the unit’s ability to perform its mission. It is clear then that these subpopulations within the military are different from the general civilian population, and guidance on managing their use of dietary supplements needs to be tailored to address their specific needs. This expert committee analyzed the patterns of dietary supplement use among military personnel, and by examining published reviews of the scientific evidence, the committee identified those dietary supplements that are beneficial and/or warrant concern due to risks to health or performance. The committee also developed a system to monitor adverse health effects and recommended a framework to identify the need for active management of dietary supplement use by military personnel. Specifically, the committee did the following: 1. It reviewed survey data and findings made available to the com- mittee related to supplement use by military personnel to identify (a) which dietary supplements are of most prevalent use, with consideration of dif- ferences according to demographic factors such as age, rank, sex, deploy- ment status, military occupational specialty, organization, and unit; and (b) expectations of benefits and reasons for use of dietary supplements by military personnel. 2. It identified information gaps regarding dietary supplement use by military personnel and recommended processes and designs by which cur- rent and future usage of supplements (including dosages, quality, and forms of supplement) should be monitored, surveyed, analyzed, reported, and the resultant data shared. 3. It selected a limited number of dietary supplements from those identified as commonly used. On the basis of already published reports that review the available scientific evidence, the committee identified those sup- plements that may be of benefit and/or pose serious hazards to the health

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xiii PREFACE and/or physical and cognitive performance capability of military personnel and determined whether further examination and integrative evaluation or research on each is warranted. The committee considered potential effects of supplement withdrawal and interactions. 4. It considered existing military policies for managing dietary supple- ments, and assessed the applicability to a military setting of the framework outlined in the 2005 IOM report Dietary Supplements: A Framework for Ealuating Safety and determined how it could be modified to determine which supplements need active management by the military. 5. It proposed an approach that could be followed to monitor military personnel for adverse health effects that might indicate a concern associated with consumption of dietary supplements. The DoD has provided many policies and regulations on nutrition for military personnel in many different settings; however, there is currently no systematic approach by which the risks and benefits of the use of dietary supplements by the military are evaluated and whereby parallel service- wide policies address their management. In the absence of those policies, the DoD relies on the monitoring of dietary supplement safety through the FDA. This approach might be adequate for the general public and for those in the military service that perform tasks similar to those of civilians; however, a different approach is needed for specific military subpopulations so that risks that might compromise the success of military operations are not overlooked, and potential benefits in performance or health from use of dietary supplements by military personnel are realized. The committee carried out its work over 18 months and held three meetings and numerous teleconferences. The first meeting of the committee was held in conjunction with a 2-day workshop. Speakers addressed the is- sues related to dietary supplement use in the military and included original data on recent military survey instruments. These presentations were useful for the committee’s deliberations and recommendations and are included in this report as individually authored papers in Appendix B. The committee expresses its appreciation to Andrew Young, Chief of the Military Nutrition Division and representative from the DoD for this task, for generously giving his time and help and for being available to clarify the task of the committee. Special thanks are extended to Rebecca Costello of the Office of Dietary Supplements; Wayne B. Jonas, Joan Walter, Christine Choate, and Deborah Ader from the Samueli Institute; and Patricia Deuster from the Uniformed Services University of the Health Sciences who helped delineate the task, and to Jean Louis Belard from the Telemedicine and Advanced Technology Research Center (TATRC) for his invaluable input during the first committee meeting. In addition, the committee thanks COL Karl Friedl, Director of TATRC, who continues to support the work of

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xi PREFACE the CMNR and was readily available to provide the appropriate contacts needed to gather information for the committee. On behalf of the committee, I sincerely thank the workshop partici- pants and speakers for addressing topics critical to the completion of the committee’s work. These presentations were important reference sources for the committee. Each speaker provided an excellent presentation, pre- pared a manuscript of the presentation (see Appendix B), and worked with IOM staff throughout the revision process. Presenters of military surveys on dietary supplements deserve special thanks for going the extra mile in answering questions and analyzing data throughout the study at the committee’s request. Further, the committee wants to express its deepest gratitude to David Dinges for his effort and committed participation as a consultant to the committee who helped with drafts of the report and provided valuable comments. The quality of the report was significantly improved by the comments of external reviewers, and the diligent oversight of the National Research Council monitor, John Bailar and the coordinator, Robert Cous- ins. The committee expresses its gratitude to them as well. The committee owes a strong debt of gratitude to the FNB staff for their professionalism and effectiveness in ensuring that our committee adhered to its task statement, for providing discipline and experience in helping to assemble the report and effectively respond to reviewers, and for providing background research support and organizing our meetings. In particular, we thank Senior Program Officer Maria Oria, who worked on numerous drafts and revisions. Ably assisting Dr. Oria in her efforts were Program Associate Sandra Amamoo-Kakra and Research Associates Shannon Wisham and Alice Vorosmarti. The committee also wants to ac- knowledge the excellent work of Hilary Ray who edited numerous versions of the report. The committee is also grateful to the overall guidance and continuous support of Linda Meyers, FNB Director. And finally I want to thank the members of this committee for their diligent and collegial work. I have worked with many committees over the years, and the members of this committee will always have my deepest re- spect and admiration for their individual accomplishments and their ability to work as a group on these important issues. I hope our readers will find this report informative and useful. M.R.C. Greenwood, Chair Committee on Dietary Supplement Use by Military Personnel

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Contents SUMMARY 1 1 INTRODUCTION 17 2 RECENT SURVEY FINDINGS AND IMPLICATIONS FOR FUTURE SURVEYS OF DIETARY SUPPLEMENT USE 36 3 VITAMINS AND ESSENTIAL MINERALS FOR MILITARY PERSONNEL 72 4 OTHER DIETARY SUPPLEMENTS FOR MILITARY PERSONNEL 84 5 FRAMEWORK TO REVIEW THE SAFETY OF DIETARY SUPPLEMENTS FOR USE BY MILITARY PERSONNEL 296 6 MONITORING ADVERSE HEALTH EFFECTS ASSOCIATED WITH DIETARY SUPPLEMENT USE BY MILITARY PERSONNEL 336 7 RESEARCH NEEDS 368 APPENDIXES A Workshop Agenda 377 (on CD) B Workshop Papers x

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xi CONTENTS C Findings from Recent Surveys on Dietary Supplement Use by Military Personnel and the General Population 383 D Case Studies 420 E Adverse Event Reporting Forms 427 F Biographical Sketches of Workshop Speakers 435 G Biographical Sketches of Committee Members 443 H Acronyms and Abbreviations 450 I Glossary 454