Caffeine in Food and Dietary Supplements: Examining Safety: Workshop Summary (2014)

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C Biographical Sketches of Workshop Speakers and Moderators SPEAKERS: OPENING REMARKS Margaret A. Hamburg, M.D., is commissioner of the Food and Drug Administration (FDA), where she has served since May 2009. As FDA commissioner, she is advancing regulatory science, medical product in- novation, and globalization of the agency while overseeing the imple- mentation of groundbreaking laws to curb the use of tobacco and to en- hance food safety. She has undertaken major efforts to streamline and modernize the FDA’s regulatory pathways. Before joining the FDA, Dr. Hamburg was vice president and senior scientist at the Nuclear Threat Initiative. In the 1990s, as New York City’s health commissioner, she launched several major initiatives, including the nation’s first public health bioterrorism preparedness program and an internationally recog- nized program to curtail the resurgence and spread of tubercle bacillus. President Clinton later named her assistant secretary for planning and evaluation in the U.S. Department of Health and Human Services. Michael R. Taylor, J.D., is deputy commissioner for foods and veteri- nary medicine at the FDA. In this position, he provides leadership and direction to the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. He also works closely with the foods- related programs of the FDA’s inspection and compliance arm, the Of- fice of Regulatory Affairs. Dr. Taylor is responsible for establishing a modern, science-based, and prevention-oriented food safety program for domestic and imported foods. He also leads such critical areas as food labeling, nutrition, animal drug safety and effectiveness, and scientific 185 

186 CAFFEINE IN FOOD AND DIETARY SUPPLEMENTS capacity. Dr. Taylor served previously in senior positions at the FDA and the U.S. Department of Agriculture, as a research professor in academia, and on several National Academy of Sciences (NAS) expert committees. SPEAKERS Amelia M. Arria, Ph.D., is associate professor of behavioral and com- munity health and director of the Center on Young Adult Health and De- velopment at the University of Maryland, College Park, School of Public Health. She is the principal investigator on the College Life Study, a 10- year longitudinal prospective study of college students. Dr. Arria has conducted research studies on adolescent and young adult health risk behaviors, including energy drink consumption patterns and the relation- ship between energy drink use and other forms of substance use. She is currently involved in several efforts to translate research findings for parents and policy makers. Regan L. Bailey, Ph.D., R.D., is a nutritional epidemiologist in the Of- fice of Dietary Supplements, Office of Disease Prevention, at the Nation- al Institutes of Health (NIH). Dr. Bailey is also the director of the annual Mary Frances Picciano Dietary Supplement Research Practicum and the director of career development and outreach. In addition, she is an ad- junct professor in the Department of Foods and Nutrition at Purdue Uni- versity. The overarching goal of her research program is to prevent or lessen the risk of chronic disease through nutrition. Dr. Bailey has con- siderable expertise working with the National Health and Nutrition Ex- amination Survey. She is a member of the American Society for Nutri- tion and the Academy of Nutrition and Dietetics. She is also on the execu- tive board of the Nutrition Epidemiology Research Interest Section of the American Society for Nutrition. She serves as an advisor to the International Life Sciences Institute–North America both on the Fortification Commit- tee and in the Food, Nutrition and Safety Program. She is a registered dietitian. Alvin C. Bronstein, M.D., is medical director of the Rocky Mountain Poison Center, the regional poison center for the states of Colorado, Ha- waii, Montana, and Nevada. He is also associate professor in the De- partment of Emergency Medicine, University of Colorado School of Medicine. In addition to his responsibilities as medical director, Dr. 

APPENDIX C 187 Bronstein actively participates in the poison center’s medical toxicology training program, oversees toxicology training for the center’s poison information specialists and providers, and directs the center’s Continuous Quality Improvement program. His research interests include creating new methods to deliver poison information services using computer da- tabases and poison center data surveillance and trend analysis. Christina Chambers, Ph.D., M.P.H., is professor in the Department of Pediatrics, School of Medicine, and associate director of the Clinical and Translational Research Institute at the University of California, San Die- go. She is a perinatal epidemiologist and teratologist who specializes in research related to the effects of prenatal and breastfeeding exposure to recreational substances, medications, vaccines, chemicals, and other en- vironmental agents on the developing embryo, fetus, infant, or child. Ahmed El-Sohemy, Ph.D., is associate professor in the Department of Nutritional Sciences and holds a Canada Research Chair in nutri- genomics. He is the founder of Nutrigenomix Inc. and serves as chief science officer. Dr. El-Sohemy joined the faculty at the University of Toronto in 2000 to establish a research program in nutrigenomics. The goal of his research is to identify biomarkers of dietary exposure and elu- cidate the genetic basis for variability in nutrient response and dietary preferences. He collaborates with researchers across Canada as well as the United States, Costa Rica, Denmark, Italy, Switzerland, South Korea, and Singapore. Dr. El-Sohemy has served on international expert adviso- ry panels and scientific advisory boards of several organizations, and was appointed to Health Canada’s Scientific Advisory Board. Sergi Ferré, Ph.D., M.D., is senior investigator and chief of the Integra- tive Neurobiology Section at the National Institute on Drug Abuse In- tramural Research Program. Dr. Ferré is interested in the role of receptor heteromers as targets for drug development in neuropsychiatric disorders and drug addiction. His research deals preferentially with the discovery of heteromers of receptors that are targets for addictive drugs or that are localized in brain circuits that are involved in addictive behaviors (such as dopamine, glutamate, cannabinoid, and adenosine receptors) and with the analysis of their biochemical and pharmacological properties involv- ing studies at the cellular level as well as at the in vivo level. 

188 CAFFEINE IN FOOD AND DIETARY SUPPLEMENTS Victor Fulgoni III, Ph.D., is currently senior vice president of Nutrition Impact, LLC, a consulting firm that helps food companies develop and communicate aggressive, science-based claims about their products and services. Nutrition Impact performs analyses of government food, nutri- tion, and health databases such as the National Health and Nutrition Exam- ination Surveys for clients evaluating the contribution certain food and beverage products make to nutrient intake and their effect on certain health parameters. Dr. Fulgoni previously worked for the Kellogg Company as vice president of food and nutrition research, where he helped develop a long-term research program and was involved in the company’s research and regulatory efforts to gain health claim approval from the FDA regard- ing soluble fiber from psyllium and the risk of heart disease. Jeffrey Goldberger, M.D., a recognized scholar and clinician, has been a practicing clinical cardiac electrophysiologist at Northwestern Univer- sity for 23 years. He is an innovator in the field and has been recognized as a “Top Doctor” by U.S. News & World Report and Chicago maga- zines. He has been a thought leader in the problems of sudden cardiac death, atrial fibrillation, and autonomic nervous system effects on cardiac electrophysiology, leading several multidisciplinary programs. He has written more than 200 publications, and he has served on multiple na- tional committees of the American Heart Association and American Col- lege of Cardiology. Dr. Goldberger is an active participant in both un- dergraduate and graduate medical education and is involved in several community and national organizations in leadership roles. Roland R. Griffiths, Ph.D., is professor in the Departments of Psychia- try and Neurosciences at the Johns Hopkins University School of Medi- cine. His principal research focus in both clinical and preclinical labora- tories has been on the behavioral and subjective effects of mood-altering drugs. He is also a member of the Expert Advisory Panel on Drug De- pendence for the World Health Organization (WHO). Dr. Griffiths’s re- search has provided the most complete description of caffeine withdraw- al syndrome to date, including documenting clinically significant func- tional impairment in some people. His research was the first to rigorously demonstrate the following: (1) that caffeine produces reliable mood- altering effects at doses far lower than previously thought possible; (2) that caffeine functions as a reliable reinforcer when administered in bev- erages or capsules; (3) that caffeine withdrawal potentiates the reinforc- ing effects of caffeine; and (4) that some people become psychiatrically 

APPENDIX C 189 dependent on caffeine in that they fulfill Diagnostic and Statistical Man- ual criteria for substance dependence applied to caffeine by being unable to quit despite repeated attempts to do so, by having a medical or psycho- logical condition that is exacerbated by caffeine, and by continuing to use caffeine to avoid caffeine withdrawal symptoms. John P. Higgins, M.D., M.B.A., is associate professor of medicine (car- diology) at the University of Texas Medical School, Houston, chief of cardiology at Lyndon B. Johnson General Hospital, and director of exer- cise physiology at the Institute for Sports Medicine and Human Perfor- mance at Memorial Hermann. Dr. Higgins was previously on the staff at the Veteran’s Administration West Roxbury hospital as an attending car- diologist and director of the Cardiac Stress Laboratory (instructor in medicine, Harvard Medical School). He currently sees patients at Lyndon B. Johnson General Hospital. He has received the prestigious Dean’s Teaching Excellence Award at the University of Texas Medical School at Houston 5 years in a row (2008–2013). Diane C. Mitchell, M.S., R.D., is senior research scientist and the direc- tor of the Diet Assessment Center in the Department of Nutritional Sci- ences at the Pennsylvania State University. In this role she is responsible for managing external and internal research studies. She also manages proposal development, budget administration, manuscript development, and project management. Her research interests include validating and improving various diet assessment methodologies, accuracy and sources of error in diet recall, analysis of dietary patterns, diet quality, and data- base development. Ms. Mitchell is also scientific consultant to the Inter- national Life Science Institute of North America, Caffeine Working Group, to provide an update to earlier work on the caffeine intakes of the U.S. population. Charles P. O’Brien, M.D., Ph.D., is the Kenneth E. Appel Professor of Psychiatry at the University of Pennsylvania. He also established and directs a clinical research program that has had a major impact on the treatment of addictive disorders. His work involves discovery of central nervous system changes involved in relapse, new medications, behavior- al treatments, and instruments for measuring the severity of addictive disorders. He led the discovery of the effects of alcohol on the endoge- nous opioid system and developed a new treatment for alcoholism. Dr. O’Brien was elected to the Institute of Medicine (IOM) of the NAS in 

190 CAFFEINE IN FOOD AND DIETARY SUPPLEMENTS 1991, and he has received numerous research and teaching awards as well as an honorary doctorate from the University of Bordeaux. Dr. O’Brien is past president of the American College of Neuropsychophar- macology and the Association for Research in Nervous and Mental Dis- ease. In 2013 the president of France named him Chevalier dans l’Ordre National de la Légion d’Honneur for his contributions to Franco- American scientific collaboration. Ashley Roberts, Ph.D., is senior vice president in the Food and Nutri- tion Group at Intertek Cantox. In this capacity, Dr. Roberts advises and assists international clients with issues that are scientific, regulatory, and toxicological in nature. In addition, he assists clients wishing to design and develop scientific research programs and helps those who are devel- oping regulatory strategies for food additives, foods that are generally recognized as safe, and novel foods. While in the food industry he was largely responsible for developing scientific strategies for establishing safety and gaining regulatory approvals for new food ingredients throughout the world. Prior to working for Intertek Cantox, Dr. Roberts worked in the area of scientific and regulatory affairs for a multinational food company for more than 10 years. Prior to that he worked in two leading European contract research organizations conducting drug me- tabolism and pharmacokinetics studies and phase I clinical trials. Andrew P. Smith, Ph.D., is professor in the School of Psychology and director of the Centre for Occupational and Health Psychology at Cardiff University. His research covers the areas of occupational and health psy- chology with the major emphasis being on well-being. Specifically, Dr. Smith has conducted extensive research on the nonauditory effects of noise on cognition and health. In addition, he conducts research on stress and fatigue in both the workplace and life in general. Dr. Smith’s interests in health psychology cover two main themes: health-related behaviors (ef- fects of nutrition, caffeine, and chewing gum on behavior) and minor ill- nesses (psychosocial risk factors for susceptibility to colds and influenza; effects of upper respiratory tract infections on mood and cognition). Jennifer Temple, Ph.D., is associate professor in the Departments of Exercise and Nutrition Sciences and Community Health and Health Be- havior at the University of Buffalo. Dr. Temple is also director of the Nutrition and Health Research Laboratory in the School of Public Health and Health Professions at the University at Buffalo. Her research pro- 

APPENDIX C 191 gram focuses on several major areas, including physiological and behav- ioral effects of caffeine intake in children and adolescents, gender differ- ence in the effects of caffeine, food reinforcement and sensory system influences on eating in adults, and the relationship between food rein- forcement and weight change over time. Currently, Dr. Temple is inves- tigating the cardiovascular, cognitive, subjective, and reinforcing effects of caffeine in pre- and post-pubertal children and across the menstrual cycle. MODERATORS Richard H. Adamson, Ph.D., is president of TPN Associates, LLC, a consulting firm specializing in toxicology, pharmacology, and nutrition issues. He spent 2 years as a commissioned officer in the U.S. Public Health Service and then became a civil servant at NIH. At NIH he was the director of the Division of Cancer Etiology and scientific director of the National Cancer Institute. In 1994 Dr. Adamson joined the American Beverage Association (ABA) as vice president for scientific and tech- nical affairs. He retired from the ABA in December 2004. He has pub- lished more than 250 papers, serves on several editorial boards, and has received several honors and awards. James R. Coughlin, Ph.D., is president of Coughlin & Associates. He has more than 35 years of experience in addressing and shaping the cur- rent understanding of food and nutrition science in the United States and Europe, particularly in the areas of food, chemical and environmental toxicology and safety, chemical risk assessment, risk-benefit evaluation of foods and food ingredients, generally recognized as safe (GRAS) food additive safety evaluations, and scientific risk communication. Before undertaking his current role as a consultant in 1991, he spent 10 years at General Foods Corporation and Kraft Foods Inc. managing external toxi- cology, safety, and regulatory affairs, including several years as Director of International Scientific Relations. Health and regulatory issues sur- rounding coffee/caffeine is one of his areas of expertise. In the early 1990s, he served as President of the Association for Science and Infor- mation on Coffee. He has been deeply involved in the assessment and management of California Proposition 65 requirements since the law’s passage in 1986. He served for many years on the Editorial Advisory Board of Prop 65 News and the Prop 65 Clearinghouse Advisory Board. 

192 CAFFEINE IN FOOD AND DIETARY SUPPLEMENTS Stephen R. Daniels, M.D., Ph.D., is professor of pediatrics and chairman in the Department of Pediatrics at the University of Colorado School of Medicine. He also serves as Pediatrician-in-Chief at Children’s Hospital Colorado. Dr. Daniels’s area of expertise is preventive cardiology, with a longtime interest in the application of sophisticated epidemiologic and bio- statistical methods to pediatric clinical research problems. He is interested in the causes of blood pressure elevation and cholesterol abnormalities in children and adolescents, particularly the role that obesity may play in these health issues; development of structural and functional abnormalities in the heart and vascular system, including cardiovascular abnormalities occurring in pediatric patients with diabetes mellitus; as well as the rela- tionship of left ventricular hypertrophy to obesity and hypertension. The role of lifestyle factors, such as diet and physical activity, is central to many of Dr. Daniels’s studies. Mark Feeley, M.Sc., is associate director of the Bureau of Chemical Safety in the Food Directorate of Health Canada. The Bureau of Chemi- cal Safety of Health Canada is responsible for policy, standard setting, risk assessment, research, and evaluation activities with respect to chem- icals in foods in Canada. Chemicals under the authority of the bureau include food additives; food packaging materials, processing aids, and incidental additives; food allergens; food contaminants; and novel foods. Mr. Feeley is the head of the Canadian delegation for the Codex Com- mittee on Contaminants in Food, a current member of the Joint Food and Agriculture Organization/WHO Expert Committee on Food Additives Roster of Toxicological and Epidemiological Experts, and a member of the WHO Expert Advisory Panel on Food Safety. Thomas J. Gould, Ph.D., is director of the Neuroscience Program, head of the Neurobiological Investigations of Learning & Addiction lab, and a professor of psychology at Temple University. In addition to affiliations with the psychology department and the neuroscience pro- gram, Dr. Gould has a secondary appointment in the Center for Sub- stance Abuse Research at the Temple University School of Medicine, and he is also an investigator and member of the Center for Interdisci- plinary Research on Nicotine Addiction at the University of Pennsylva- nia. His current research interest is the neurobiology of learning and memory with a specific focus on identifying the cellular and molecular events that underlie the effects of nicotine and ethanol on learning and memory. Current projects in the lab include an examination of the ef- 

APPENDIX C 193 fects of nicotine on hippocampus functioning and hippocampus- dependent learning. Steven E. Lipshultz, M.D., is chief of staff of Holtz Children’s Hospital, Executive Associate Dean for Child Health, and Professor and Chairman of Pediatrics at the University of Miami, Miller School of Medicine. He has been the principal investigator in a number of groundbreaking NIH studies on the causes and treatment of cardiomyopathies in children. He studies the efficacy, long-term side effects, and outcomes of pharmaco- logical agents in children using cross-sectional approaches. Another ma- jor focus of his research is development of surrogate outcome measures and biomarkers of adult-onset disease, such as coronary artery disease and health failure and prenatal and postnatal factors that moderate out- comes. Dr. Lipshultz has served on the faculties at Harvard Medical School and Boston University School of Medicine. Barbara J. Petersen, Ph.D., M.P.H., is principal scientist in Exponent’s Health Sciences Center for Chemical Regulation and Food Safety. She is also a specialist in addressing regulatory issues involving exposure and risk assessments including the FDA, the Environmental Protection Agen- cy (EPA), and the European Food Safety Authority. Dr. Petersen chaired the WHO working group on methods for estimating intakes of food addi- tives, nutrients, new biochemical traits associated with foods derived from modern biotechnology (genetically modified organisms), and contami- nants in foods. She also served as Principal Investigator for the National Cancer Institute’s International FOODBASE project, a major effort to collect and computerize descriptive and summary information on food consumption surveys conducted in more than 40 countries. Dr. Petersen has provided statistical support to the FDA’s Center for Food Safety and Nutrition, including developing criteria for evaluating nutrition databases, and specifically for the International Interface Standard for food databases and to EPA’s Office of Research and Development. Joseph V. Rodricks, Ph.D., is a founding principal of ENVIRON, and an internationally recognized expert in toxicology and risk analysis. He has consulted for hundreds of manufacturers, government agencies and for the WHO in the evaluation of health risks associated with human ex- posure to chemical substances of all types. Dr. Rodricks came to consult- ing after a 15-year career as a scientist at the FDA. In his last 4 years at the FDA, he served as Associate Commissioner for Health Affairs. His 

194 CAFFEINE IN FOOD AND DIETARY SUPPLEMENTS experience extends from pharmaceuticals, medical devices, consumer products, and foods to occupational chemicals and environmental con- taminants. He has served on the National Research Council’s Board on Environmental Studies and Toxicology, and on 30 boards and commit- tees of the NAS and the IOM. Stephen Schaffer, Ph.D., is professor of pharmacology at the University of South Alabama. For 11 years, he served as a member of the American Heart Association Southeast Regional Consortium study section. His re- search interests include ischemia-reperfusion injury, the effects of diabe- tes and insulin on the heart, and the cardiac effects of the sulfur- containing amino acid taurine. Dr. Schaffer’s work has been instrumental in establishing an important physiological role for taurine. In 1986 he discovered that taurine depletion caused a shift in energy metabolism of the heart in favor of glucose, an effect related to impaired mitochondrial function. He recently discovered that taurine deficiency leads to a de- crease in the expression of mitochondria-encoded proteins, an effect that reduces the activity of the electron transport chain and enhances superox- ide production by the mitochondria.