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Caffeine in Food and Dietary Supplements Examining Safety: Workshop Summary Planning Committee for a Workshop on Potential Health Hazards Associated with Consumption of Caffeine in Food and Dietary Supplements Leslie Pray, Ann L. Yaktine, and Diana Pankevich, Rapporteurs Food and Nutrition Board Board on Health Sciences Policy PREPUBLICATION COPY: UNCORRECTED PROOFS

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 NOTICE: The workshop that is the subject of this workshop summary 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. This activity was supported by Contract/Grant No. HHSF223200810020I between the National Academy of Sciences and the Department of Health and Human Services, Food and Drug Administration. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity. International Standard Book Number 0-309-0XXXX-X Additional copies of this workshop summary are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2014 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. Suggested citation: IOM (Institute of Medicine). 2014. Caffeine in food and dietary supplements: Examining safety: Workshop Summary. Washington, DC: The National Academies Press.

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((Knowing is not enough; 1ve must apply. Willing is not enough; we must do.)) -Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Advising the Nation. Improving Health. PREPUBLICATION COPY: UNCORRECTED PROOFS

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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 Academy 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 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. C. D. Mote, Jr., 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. Harvey V. Fineberg 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. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council. www.national-academies.org PREPUBLICATION COPY: UNCORRECTED PROOFS

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Planning Committee for a Workshop on Potential Health Hazards Associated with Consumption of Caffeine in Food and Dietary Supplements1 LYNN R. GOLDMAN (Chair), Dean, School of Public health and Health Sciences The George Washington University, Washington, DC JAMES R. COUGHLIN, President, Coughlin & Associates, San Diego, CA STEPHEN R. DANIELS, Professor and Chair, Department of Pediatrics, University of Colorado, Aurora THOMAS J. GOULD, Professor of Psychology, Department of Psychology, Director of the Neuroscience Program, Temple University, Philadelphia, PA STEVEN E. LIPSHULTZ, Professor and Chairman Pediatrics and Endowed Chair in Pediatric Cardiology, Children’s Hospital of the University of Miami, FL CARL L. KEEN, Professor and Chair, Department of Nutrition, University of California, Davis THERESA ANN NICKLAS, Professor, Department of Pediatrics, Children’s Nutrition Research Center, Baylor College of Medicine, Houston, TX BARBARA J. PETERSEN, Principal Scientist, Exponent, Inc., Washington, DC 20036 JOSEPH V. RODRICKS, Principal, Environ International Corp., Arlington, VA IOM Staff Ann L. Yaktine, Study Director Diana Pankevich, Senior Program Officer Janet Mulligan, Research Associate Faye Hillman, Financial Associate Geraldine Kennedo, Administrative Assistant Ann L. Yaktine, Interim Director, Food and Nutrition Board Andrew M. Pope, Board on Director, Health Sciences Policy 1 Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. PREPUBLICATION COPY: UNCORRECTED PROOFS v

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Reviewers This workshop summary 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 workshop summary as sound as possible and to ensure that the workshop summary 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 process. We wish to thank the following individuals for their review of this workshop summary: Anne Barnhill, Perelman School of Medicine at the University of Pennsylvania Cindy D. Davis, National Institutes of Health Johanna T. Dwyer, Tufts University Medical Center Carl L. Keen, University of California, Davis Nancy S. Wellman, Florida International University Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by Eileen T. Kennedy, Tufts University. Appointed by the National Research Council and Institute of Medicine, she was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteurs and the institution. PREPUBLICATION COPY: UNCORRECTED PROOFS vii

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CONTENTS 1 INTRODUCTION 1-1 The Past, Present, and Future of Caffeine Regulation in the United States Dr. Margaret Hamburg, Commissioner of Food and Drugs, Food and Drug Administration Mr. Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine, Food and Drug Administration 2 INTAKE AND EXPOSURE TO CAFFEINE 2-1 Dr. Barbara Petersen, Exponent, Inc. (moderator) Caffeine Intake from Beverages in the United States Dr. Diane Mitchell, Penn State University Various Aspects of Caffeine Intake in America: Analysis of NHANES Dr. Victor Fulgoni III, Nutrition Impact, LLC Panelist Discussion with the Audience 3 SAFETY SIGNALS AND SURVEILLANCE 3-1 Dr. Steven Lipshultz, University of Miami (moderator) Caffeine and Energy Drink Exposure Call Surveillance Dr. Alvin Bronstein, Rocky Mountain Poison Center Safety Assessment of Caffeine in Foods and Beverages Dr. Ashley Roberts, Intertek Cantox Consulting Panelist Discussion with the Audience 4 EXPLORING SAFE CAFFEINE EXPOSURE LEVELS FOR VULNERABLE POPULATIONS 4-1 Dr. Mark Feeley, Health Canada (moderator) Health Canada’s Approach Dr. Mark Feeley, Health Canada Safe Caffeine Exposure Levels in Vulnerable Populations: Pregnant Women and Infants Dr. Christina Chambers, University of California, San Diego Risk of Adverse Effects of Caffeine and Caffeinated Products in Children and Other Vulnerable Groups Dr. Steven Lipshultz, University of Miami Panelist Discussion with the Audience 5 Caffeine Effects on the Cardiovascular System 5-1 Dr. Stephen Daniels, University of Colorado School of Medicine (moderator) Vascular Effects of Caffeine Dr. John Higgins, University of Texas Medical School, Houston Caffeine and Risk of Arrhythmia Dr. Jeffrey Goldberger, Northwestern University PREPUBLICATION COPY: UNCORRECTED PROOFS ix

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Caffeine and Risk of Hypertension Dr. Ahmed El-Sohemy, University of Toronto Panelist Discussion with the Audience 6 CAFFEINE EFFECTS ON CENTRAL NERVOUS SYSTEM AND BEHAVIORAL EFFECTS ASSOCIATED WITH CAFFEINE CONSUMPTION 6-1 Dr. Thomas Gould, Temple University (moderator) Mechanisms of the Central Effects of Caffeine Dr. Sergi Ferre, National Institute on Drug Abuse Developmental and Psychopharmacological Effects of Caffeine Dr. Jennifer Temple, University of Buffalo Addictive Properties of Caffeine Dr. Roland Griffiths, Johns Hopkins University DSM-5: Substance Related and Addiction Disorders Dr. Charles O’Brien, University of Pennsylvania, Philadelphia Energy Drink Use and Risk-Taking During Adolescence and Young Adulthood Dr. Amelia Arria, University of Maryland Caffeine, Performance, and Well-Being Dr. Andrew Smith, Cardiff University Panelist Discussions with the Audience 7 OTHER COMPOUNDS IMPACTING CAFFEINE EFFECTS 7-1 Dr. Stephen Schaffer, University of South Alabama (moderator) Interaction Between Energy Drink Ingredients and Caffeine Dr. Stephen Schaffer, University of South Alabama PANELIST REMARKS Dr. Carl Keen, University of California, Davis Dr. John Higgins, University of Texas Medical School, Houston Dr. Christina Chambers, University of California, San Diego Dr. Jeffrey Goldberger, Northwestern University Panelist Discussion with the Audience 8 PUBLIC COMMENTS 8-1 Dr. Richard H. Adamson, TPN Associates, LLC Dr. Robert Arnot, Monster Beverage Dr. Joel Geerling, Harvard Medical School Dr. John P. Higgins, University of Texas Medical School, Houston Dr. Richard Kingston, SafetyCall International Dr. Emilia C. Lonardo, Grocery Manufacturers Association Mr. Rend Al-Mondhiry, Council for Responsible Nutrition Dr. J. Philip Saul, University of South Carolina (for Monster Beverage, Inc.) Dr. John R. White, Jr., Washington State University 9 MOVING FORWARD: FILLING THE DATA GAPS 9-1 Dr. Joseph Rodricks, ENVIRON (moderator) PREPUBLICATION COPY: UNCORRECTED PROOFS x

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Panelist Remarks Dr. Amelia M. Arria, University of Maryland Dr. Alvin C. Bronstein, Rocky Mountain Poison Center Dr. Regan L. Bailey, Office of Dietary Supplements, National Institutes of Health Dr. Christina Chambers, University of California, San Diego Dr. Steven E. Lipshultz, University of Miami Dr. Stephen Schaffer, University of South Alabama Panelist Discussion with the Audience APPENDIXES A WORKSHOP AGENDA A-1 B WORKSHOP PARTICIPANT LIST B-1 C SPEAKER BIOGRAPHIES C-1 D WORKSHOP STATEMENT OF TASK D-1 E ABBREVIATIONS AND ACRONYMS E-1 PREPUBLICATION COPY: UNCORRECTED PROOFS xi

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