Caffeine in Food and
Dietary Supplements

Examining Safety

WORKSHOP SUMMARY

Leslie Pray, Ann L. Yaktine, and Diana Pankevich, Rapporteurs

Planning Committee for a Workshop on Potential Health Hazards
Associated with Consumption of Caffeine
in Food and Dietary Supplements

Food and Nutrition Board

Board on Health Sciences Policy

INSTITUTE OF MEDICINE
              OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

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Lesl Pray, Ann L. Yaktine and Diana Pankevich, R lie n e, Rapporteurs s Planning Commiittee for a Workshop on P W Potential He ealth Hazards Asso ociated with Consumptio of Caffein C on ne in Food and Dietary Supp i D plements Food and Nutrition B d Board Board on He B ealth Science Policy es

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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-13: 978-0-309-29749-3 International Standard Book Number-10: 0-309-29749-4 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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The National Acade emy of Scienc is a privat nonprofit, self-perpetuati ces te, ing society of distinguish scholars en y hed ngaged in scien ntific and engin neering researc ch, dedicat to the furth ted herance of scie ence and technnology and to their use for t the general welfare. Upo the authority of the charte granted to it by the Congre l on y er ess in 1863, the Academ has a man my ndate that req quires it to ad dvise the fedeeral governnment on scie entific and tecchnical matter Dr. Ralph J. Cicerone is rs. h preside of the Natio Academy of Sciences. ent onal The National Acade emy of Engin neering was e established in 1964, under t the charter of the Natio onal Academy of Sciences, as a parallel organization of nding engineers It is autonomo in its admin outstan s. ous nistration and i the selection of in n its mem mbers, sharing with the Nation Academy o Sciences the responsibility f w nal of for advisin the federal government. The National Academy of E ng T Engineering al lso sponsor engineering programs aim at meetin national ne rs g med ng eeds, encouragges educati and researc and recogn ion ch, nizes the super rior achieveme ents of engineeers. Dr. C. D. Mote, Jr., is president of th National Aca D he ademy of Engin neering. The Institute of Med dicine was estaablished in 197 by the Natio 70 onal Academy of Science to secure th services of eminent memb es he bers of approp priate professio ons in the examination of policy matter pertaining to the health of the public. T e rs o f The Institut acts under th responsibilit given to the National Acad te he ty demy of Scienc ces by its congressional charter to be an adviser to the federal gover c c n e rnment and, up pon its own initiative, to identify issues of medical car research, an education. D n i re, nd Dr. Harvey V. Fineberg is president of the Institute of Medicine. y t f The Na ational Resea arch Council was organized by the Natio w d onal Academy of Science in 1916 to associate the broad commun of science and technolo es b nity e ogy with th Academy’s purposes of fu he urthering know wledge and adv vising the fede eral governnment. Function ning in accordance with gene policies determined by t eral the Academ the Counc has become the principal operating age my, cil e l ency of both tthe National Academy of Sciences an the Nationa Academy of Engineering in o nd al f providiing services to the govern t nment, the pu ublic, and the scientific a e and engineeering communi ities. The Coun is administ ncil tered jointly by both Academ y mies and the Institute of Medicine. Dr. Ralph J. Cicero and Dr. C. D. Mote, Jr., a e M R one are chair an vice chair, respectively, of the National Research Coun nd r ncil. w www.national l-academies.o org

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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 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 CARL L. KEEN, Professor and Chair, Department of Nutrition, University of California, Davis STEVEN E. LIPSHULTZ, Professor and Chairman of Pediatrics and Endowed Chair in Pediatric Cardiology, Children’s Hospital of the University of Miami, FL 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 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, Director, Board on 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. v

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Reviewers This workshop summary has been reviewed in draft form by in- dividuals 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 pos- sible and to ensure that the workshop summary meets institutional stand- ards 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 construc- tive 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 Institute of Medicine, she was responsible for mak- ing 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 vii

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viii REVIEWERS content of this workshop summary rests entirely with the rapporteurs and the institution.

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Contents ABBREVIATIONS AND ACRONYMS xv 1 INTRODUCTION 1 Background and Workshop Objectives, 1 About This Report, 2 The Past, Present, and Future of Caffeine Regulation in the United States, 4 References, 10 2 INTAKE AND EXPOSURE TO CAFFEINE 11 Caffeine Intake from Beverages in the United States, 11 Various Aspects of Caffeine Intake in America: Analysis of NHANES, 20 Panelist Discussion with the Audience, 26 References, 30 3 SAFETY SIGNALS AND SURVEILLANCE 31 Caffeine and Energy Drink Exposure Call Surveillance, 31 Safety Assessment of Caffeine in Foods and Beverages, 38 Panelist Discussion with the Audience, 43 References, 47 4 EXPLORING SAFE CAFFEINE EXPOSURE LEVELS FOR VULNERABLE POPULATIONS 51 Health Canada’s Approach, 52 Safe Caffeine Exposure Levels in Vulnerable Populations: Pregnant Women and Infants, 53 ix

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x CONTENTS Risk of Adverse Effects of Caffeine and Caffeinated Products in Children and Other Vulnerable Groups, 58 Panelist Discussion with the Audience, 63 References, 66 5 CAFFEINE EFFECTS ON THE CARDIOVASCULAR SYSTEM 67 Vascular Effects of Caffeine, 67 Caffeine and Risk of Arrhythmia, 73 Caffeine and Potential Risk of Hypertension, 78 Panelist Discussion with the Audience, 84 References, 86 6 CAFFEINE EFFECTS ON THE CENTRAL NERVOUS SYSTEM AND BEHAVIORAL EFFECTS ASSOCIATED WITH CAFFEINE CONSUMPTION 89 Mechanisms of the Central Nervous System Effects of Caffeine, 89 Developmental and Psychopharmacological Effects of Caffeine, 96 Addictive Properties of Caffeine, 102 DSM-5: Substance-Related and Addiction Disorders, 108 Energy Drink Use and Risk Taking During Adolescence and Young Adulthood, 110 Caffeine, Performance, and Well-Being, 114 Panelist Discussion with the Audience, 118 References, 123 7 OTHER COMPOUNDS IMPACTING CAFFEINE EFFECTS 129 Interaction Between Energy Drink Ingredients and Caffeine, 129 Panelist Remarks, 134 Panelist Discussion with the Audience, 138 References, 141 8 PUBLIC COMMENTS 145 Richard H. Adamson, Ph.D., TPN Associates, LLC, 145 Bob Arnot, M.D., Medical Advisor to Monster Beverage, Inc., 146 Joel Geerling, M.D., Ph.D., Harvard Medical School, Boston, 146

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CONTENTS xi John P. Higgins, M.D., M.B.A., University of Texas Medical School, Houston, 147 Richard Kingston, Pharm.D., SafetyCall International, Bloomington, Minnesota, 147 Emilia C. Lonardo, Ph.D., Grocery Manufacturers Association, Washington, DC, 148 Rend Al-Mondhiry, J.D., Council for Responsible Nutrition, Washington, DC, 149 J. Philip Saul, M.D., University of South Carolina, Mount Pleasant, and Consultant to the American Beverage Association, 150 John R. White, Jr., Pharm.D., Washington State University, Spokane, 150 References, 151 9 MOVING FORWARD: FILLING THE DATA GAPS 153 Panelist Remarks, 155 Panelist Discussion with the Audience, 160 Reference, 166 APPENDIXES A Workshop Agenda 167 B Workshop Attendees 175 C Biographical Sketches of Workshop Speakers and Moderators 185 D Workshop Statement of Task 195

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Boxes, Figures, and Tables BOXES 1-1 Workshop Objectives, 3 1-2 Major Overarching Themes of Workshop Discussion, 4 1-3 Dietary Supplements, 9 2-1 Key Points Made by Individual Speakers, 12 3-1 Key Points Made by Individual Speakers, 32 4-1 Key Points Made by Individual Speakers, 51 5-1 Key Points Made by Individual Speakers, 68 6-1 Key Points Made by Individual Speakers, 90 7-1 Key Points Made by Individual Speakers, 130 9-1 Key Points Made by Individual Speakers, 154 FIGURES 2-1 Mean usual intake of caffeine for total sample population and caffeine consumers only, 22 2-2 The 90th percentiles of usual caffeine intake for total sample population and caffeine consumers only, 23 xiii

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xiv BOXES, FIGURES, AND TABLES 2-3 Mean and percentiles of usual caffeine intake per consumption event, 24 3-1 U.S. poison center calls per day, 2000–2012, 34 3-2 Caffeine and energy product exposure calls per day over time, 35 4-1 U.S. emergency department visits involving caffeinated energy drinks in patients age 12 years and older, 2005–2011, 60 4-2 Calls regarding the intentional or accidental consumption of energy drinks to individual New South Wales, Australia, poison control centers, 2004–2010, 60 4-3 Poison center energy drink calls over time, 2010–2011, 63 5-1 Odds ratios of risk of myocardial infarction with coffee intake, 82 6-1 Results from operant response test for caffeinated soda, 99 6-2 Summary of results from prospective study on energy drink use among second-year college students and the use of other substances during the third year of college, 113 6-3 Typical findings reported in the 1990s, 115 TABLES 2-1 Number of Users and Mean and 90th Percentile Daily Intakes of Total Caffeinated Beverages, by Age, 16 2-2 Mean Caffeine Intake by Age and Beverage Category, 17 2-3 Caffeine Intakes for Users Within Each Beverage Category, 18 3-1 Energy Product Calls by Generic Code, June 18, 2010, Through July 22, 2013, 36 3-2 Medical Outcomes for 6,724 Energy Product Calls Received Between June 18, 2010, and July 22, 2013, 37

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Abbreviations and Acronyms ADHD attention deficit hyperactivity disorder CDC U.S. Centers for Disease Control and Prevention COMT catechol-O-methyltransferase CRN Council for Responsible Nutrition DAWN Drug Abuse Warning Network DSM Diagnostic and Statistical Manual ECF endothelial cell function EFSA European Food Safety Authority FDA U.S. Food and Drug Administration GABA gamma-aminobutyric acid GRAS generally recognized as safe ILSI International Life Sciences Institute IOM Institute of Medicine MSN medium spiny neuron NHANES National Health and Nutrition Examination Survey NOAEL no-observed-adverse-effect level NPDS National Poison Data System PVC premature ventricular complex xv

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xvi ABBREVIATIONS AND ACRONYMS QT Q-T wave RACC reference amount customarily consumed SHADE-ONE Study of Heart Effects from Adults Drinking Energy Beverages: On Endothelial Function