Center for Science in the Public Interest
1875 Connecticut Ave. N.W. #300
Washington, DC 20005

July 31, 1997

Lead Deputy Commissioner Michael Friedman, M.D.
U.S. Food and Drug Administration
5600 Fishers Lane
Room 1471
Rockville, MD 20857

Dear Dr. Friedman:

In 1981, the Food and Drug Administration (FDA) began advising pregnant women to "avoid caffeine-containing foods and drugs, if possible, or consume them only sparingly." 1 We commend the FDA for maintaining that advisory. Since 1981, a growing body of evidence suggests that caffeine consumption by women who are pregnant or might become pregnant increases the risk of delayed conception, 2-6 fetal growth retardation, 7-13 and miscarriage. 14-16

In addition to the effects on reproduction, caffeine has been shown to affect calcium balance and may contribute to decreased bone density and osteoporosis. 17-21 While the effect of caffeine on calcium balance may be modest, the impact on the public's health could be significant because many American women consume inadequate amounts of calcium.

Caffeine also can cause behavioral effects, including anxiety, sleeplessness, addiction, andwithdrawal upon cessation of consumption. 22-25 Those behavioral effects have been reported in children as well as in adults. 26-28

In addition, many children consume large quantities of (and may be addicted to) soft drinks and other caffeinated beverages, which are often high in calories and devoid of nutrients, in place of more nutrient-dense beverages such as fruit juice and milk. 1994 USDA data show that teenagers drink more soft drinks than milk. 29 They also show that children under 5 years drank 16% less milk than in the late 1970s and 23% more soft drinks. 30 In another study, children who consumed one or more soft drinks a day consumed one-fifth less calcium than children who did not drink soft drinks. 31

To give consumers more information to make educated decisions about caffeine consumption, we urge that the FDA implement the following measures.

I. The Food and Drug Administration should require that caffeine content be disclosed on food labels.

Caffeine is present in a variety of foods and beverages. It is found not only in coffee, tea, and colas, but also in other soft drinks, caffeinated water, ice cream, and yogurt. It is difficult for consumers to predict the caffeine content of many of those foods and beverages, since many of the products are new and the levels of caffeine vary widely between brands. For example, caffeinated bottled waters, marketed only since 1995, contain anywhere from 50-125 mg of caffeine per half-liter bottle. Also, coffee-flavored products such as coffee yogurt and coffee ice cream can contain as much caffeine as cola or tea.

Many Americans are interested in information about the caffeine content of foods and beverages so that they can manage their intake. Drivers who wish to stay awake and students studying for exams may rely on caffeine to help them stay alert. The parents of young children might wish to limit their children's consumption of foods containing this stimulant close to bedtime. Pregnant women may wish to choose products with less caffeine or entirely eliminate caffeine from their diet. Others might wish to limit their caffeine intake to help prevent such side effects as nervousness, irritability, or sleeplessness.

Thus, we urge the FDA to require that foods that contain significant amounts of caffeine (either naturally or as a food additive) disclose on the food label the amount of caffeine (in milligrams) per serving.

II. The FDA should conduct a study of the health effects of caffeine and determine what other actions should be taken to protect the public from any adverse effects of caffeine.

Caffeine is the only drug that is widely added to the food supply. It is consumed by a large proportion of the population. Caffeine is an addictive stimulant. Scientific research has demonstrated that caffeine consumption affects reproduction, behavior, and bone-mineral metabolism and has negative nutritional consequences for children.

The FDA should conduct a thorough review of the effects of caffeine on health and behavior to determine if further regulatory or educational actions should be taken to inform consumers about adverse effects associated with caffeine consumption.


Neal L. Benowitz
Departments of Medicine, Psychiatry,
and Biopharmaceutical Sciences
University of California, San Francisco
San Francisco General Hospital

Gail Bernstein
Associate Professor Director of the Division of Child
and Adolescent Psychiatry
Department of Psychiatry
University of Minnesota

Carol Boyd
Associate Professor
School of Nursing and Department of
Women's Studies
University of Michigan

Michael B. Bracken
Professor and Head
Chronic Disease Epidemiology Department
Yale University School of Medicine

Marilyn E. Carroll
Professor of Psychiatry and Neuroscience
Department of Psychiatry
University of Minnesota

Brenda Eskenazi
School of Public Health
Division of Environmental Health Sciences
University of California, Berkeley

Suzette M. Evans
Assistant Professor of Behavioral Biology
Department of Psychiatry
New York State Psychiatric Institute

Suzanne Greenberg
Assistant Professor
Department of Obstetrics and Gynecology
University of Cincinnati College of Medicine

Roland Griffiths
Department of Psychiatry and Behavioral Sciences, Department of Neuroscience
Johns Hopkins University School of Medicine

Jack E. Henningfield
Associate Professor,
Behavioral Biology
Department of Psychiatry and Behavioral Sciences
Johns Hopkins University School of Medicine

Frank Holloway
Professor and Vice Chair
Department of Psychiatry & Behavioral Sciences
University of Oklahoma Health Science Center

Stephen G. Holtzman
Department of Pharmacology
Emory University

Leonard Howell
Associate Research Professor
Yerkes Regional Primate Research Center
Emory University

John Hughes
Department of Psychiatry
University of Vermont

Jack E. James
School of Psychological Science
La Trobe University
Melbourne, Australia

Norman Kaplan
Department of Internal Medicine
Head, Hypertension Division
University of Texas Southwestern Medical Center

Milton Kotelchuck
Department of Maternal and Child Health
University of North Carolina at Chapel Hill

James D. Lane
Associate Research Professor of Medical Psychology
Department of Psychiatry and Behavioral Sciences
Duke University Medical School

Anthony Liguori
Department of Physiology and
Bowman Gray School of Medicine

JoAnn E. Manson
Associate Professor of Medicine
Division of Preventive Medicine
Brigham and Women's Hospital
Harvard Medical School

Linda Massey
Department of Food Science and Human Nutrition
Washington State University

A. Rees Midgley
Professor of Pathology
Director, Reproductive Sciences Program
University of Michigan

Alison Oliveto
Research Scientist
Department of Psychiatry
Yale University

Alice Opryszek
Director, Dietetic Internship
Department of Food Science and Human
Washington State University

Lisa Paine
Department of Maternal and Child Health
Boston University School of Public Health

Jed E. Rose
Associate Research Professor
Department of Psychiatry
Duke University Medical School

Craig R. Rush
Assistant Professor and
Chief, Laboratory of Human Behavioral Pharmacology
Department of Psychiatry and Human Behavior
University of Mississippi Medical School

David Savitz
Professor and Chair
Department of Epidemiology
University of North Carolina School of Public Health

Kenneth Silverman
Assistant Professor
Department of Psychiatry and Behavioral Sciences
Johns Hopkins University School of Medicine

Roger D. Spealman
Professor of Psychobiology
Department of Psychiatry
New England Regional Primate Research
Harvard Medical School

Meir Stampfer
Departments of Epidemiology and Nutrition
Harvard School of Public Health

Eric C. Strain
Associate Professor
Department of Psychiatry
Johns Hopkins University School of Medicine

Thomas W. Uhde
Professor and Chairman
Department of Psychiatry
Wayne State University

Phillip P. Woodson
Intelligentsia, Inc., Upper Montclair, NJ

American College of Nurse-Midwives

Association of State and Territorial Public Health Nutrition Directors

Boston Women's Health Book Collective

Center for Women's Policy Studies

Center for Science in the Public Interest

Children's Foundation

Consumer Federation of America

National Black Child Development Institute

National Council of Negro Women

National Women's Health Network

Society for Nutrition Education