There may be questions about the authority of BATF to require such labels; and

Current research findings do not resolve all questions about FAS, including safe drinking levels during pregnancy, if any, and the relationship between alcohol consumption and other factors contributing to birth defects.

BATF concluded that there was sufficient evidence to require further action by industry and government to educate women of childbearing age and others of the risk of birth defects; that responsibility for informing women of this risk should not be left solely to their doctors; that BATF has authority to order warning labels; and that special efforts should be made to reach teenagers because of recent increases in teenage pregnancies and drinking. BATF postponed decision on whether to order warning labels pending further study and industry education campaigns. (BATF's Proposed Rulemaking and Industry Response, III.)

IV. On January 31, 1978, the Senate Subcommittee on Alcoholism and Drug Abuse held a hearing on "Alcohol Labeling and Fetal Alcohol Syndrome". Warning labels were supported by Senator Strom Thurmond; Dr. Gerald Klerman of the Alcohol, Drug Abuse, and Mental Health Administration and FDA Commissioner Kennedy; Dr. Henry L. Rosett of Boston University School of Medicine, Dr. Robert J. Sokol of Case Western University, and Dr. Bennett A. Shaywitz of the Yale University School of Medicine; and Barbara Luke of Columbia Presbyterian Medical Center. State Senator Bennett D. Katz of Maine expressed reservations about the effectiveness of warning labels on behalf of the Education Commission of the States' Task Force on Responsible Decisions About Alcohol.

Among statements submitted for the record, John A. Ewing of the Center for Alcohol Studies at the University of North Carolina at Chapel Hill, Dr. LeClair Bissell of Smithers Center in New York City, retired federal employee Ted Gall, author Lucy Barry Robe, Dr. Floyd E. Bloom of the Salk Institute, and Dr. David W. Smith of the University of Washington School of Medicine supported warning labels. Wesley Apker of the National Association of State Boards of Education, John C. West of the Education Commission of the States' Task Force on Responsible Decisions About Alcohol, editor emeritus Mark Keller of the Journal of Studies on Alcohol, the Distilled Spirits Council of the United States, Inc., author Nancy Lee Hall, and the American Council on Alcoholism opposed them. (Subcommittee Hearing, January 31, 1978, IV.)

V. From enactment of the Federal Food and Drugs Act of 1906 through passage of the Federal Alcohol Administration Act of 1935 and the Federal Food, Drug, and Cosmetic Act of 1938, the Food and Drug Administration had acknowledged jurisdiction over adulteration and labeling of alcoholic beverages, but commonly deferred to the Bureau of Alcohol, Tobacco, and Firearms and its predecessors for enforcement of labeling requirements. On August 31, 1976, a Federal District Judge in the Western District of Kentucky perceived potential conflicts between enforcement of the labeling provisions of

the FAAA by BATF and of the FFDCA by FDA, and misread congressional intent so as to enjoin the FDA from enforcement of the labeling provisions of the FFDCA with respect to alcoholic beverages. (United States Attorneys are not covered by the injunction, and any may enforce the FFDCA by filing suit against industry members.) The clear meaning and legislative history of the acts, plus Senate action as recently as 1976 and reinforced by passage of the Thurmond amendment on May 7, 1979, indicate that Congress intended the labeling provisions of both the FAAA and the FFDCA to apply to alcoholic beverages. (FDA Jurisdiction Over Alcohol Labeling, V.)

VI. U.S. experience with health warning labels on cigarette packages does not prove their effectiveness or ineffectiveness in influencing behavior but undoubtedly has helped raise consumer awareness of health hazards associated with cigarettes. According to Dr. Donald Shopland of HEW's Office on Smoking and Health, Sweden's system of rotating labels is believed to be instrumental in a significant recent downturn in cigarette consumption, and a Swedish National Smoking and Health Association study supports the idea that rotating labels not only raised public awareness of the health hazards associated with cigarettes but also positively influenced behavior. Although descriptions of the U.S. tobacco industry reaction to the threat of health warnings for cigarettes provide interesting parallels, the thrust of alcohol warning labels would be to promote responsible decisionmaking generally and extreme caution during pregnancy, rather than (as with cigarettes) complete abstinence for health reasons. (The Cigarette Analogy, VI.)

SUMMARY RECOMMENDATIONS AND CONCLUSIONS

Health warning labels should be required for alcoholic beverages to inform consumers of their risks to health, particularly with respect to birth defects from alcohol consumption during pregnancy. These warnings should apply to distilled spirits, wine, and beer, and to advertising as well as labeling. Beer and wine containers should be required to indicate alcohol content by volume. Both the BATF and FDA have authority under existing law to require such label warnings, which should be supplemented by a full range of other educational techniques.

I. INTRODUCTION

On May 7, 1979, during consideration of S. 440, the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act Amendments of 1979, the Senate passed by voice vote (after refusing to table by a vote of 21 yeas, 68 nays) an amendment offered by Senator Strom Thurmond to require beverages containing more than 24 percent alcohol to bear the following warning on their labels:

Caution: Consumption of alcoholic beverages may be hazardous to your health.

The House companion to S. 440, H.R. 3916, does not contain a warning label provision.

During floor debate on this amendment, Senator Donald W. Riegle, Jr., Chairman of the Subcommittee on Alcoholism and Drug Abuse and author of S. 440, proposed a hearing on the question of consumer health warnings for alcoholic beverages to supplement a January 31, 1978, hearing on "Alcoholic Labeling and Fetal Alcohol Syndrome.' That hearing has been scheduled for September 14, 1979.

During hearings on S. 440, former Senator Harold E. Hughes, author of the Comprehensive Álcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970, testified in support of Senator Riegle's bill. Senator Hughes spoke movingly of his own history as an alcoholic and of the many tragedies he had witnessed in his years of trying to help others who suffer from alcoholism and recounted several of his experiences as first Chairman of the Subcommittee on Alcoholism and Drug Abuse. He then challenged the Subcommittee with several piercing questions, among them:

Why are we unwilling to put warning labels on alcohol to warn pregnant women of the danger to their unborn children [of consumption of alcohol during pregnancy]?

In drafting S. 440, the main purpose of which is to renew the authorizations of the National Institute on Alcohol Abuse and Alcoholism, the question of warning labels was not considered. Warning labels had, however, been the subject of considerable debate during the preceding two years. On November 15, 1977, Dr. Donald Kennedy, then Commissioner of the Food and Drug Administration (FDA), called upon the Bureau of Alcohol, Tobacco, and Firearms (BATF) in the Treasury Department to require warning labels concerning the fetal alcohol syndrome (FAS) on all alcoholic beverage containers. BATF responded by publishing in the Federal Register on January 16, 1978, an advance notice of proposed rulemaking concerning warning labels on alcoholic beverages. This advance notice requested information on whether existing labeling regulations should be amended to require a warning label on containers of alcoholic beverages warning

women of the possible birth defects resulting from consumption of alcoholic beverages during pregnancy. BATH eventually decided to postpone decision on whether to require warning labels pending further study and analysis of ongoing efforts to raise public awareness of the fatal alcohol syndrome.

On January 31, 1978, the Subcommittee on Alcoholism and Drug Abuse held a hearing on "Alcohol Labeling and Fetal Alcohol Syndrome". That hearing concentrated primarily on documenting the fetal alcohol syndrome and reviewing the efforts of the National Institute on Alcohol Abuse and Alcoholism, FDA, and BATF to warn pregnant women of this syndrome.

Following Senate passage on May 7, 1979, of S. 440, incorporating the Thurmond warning label amendment, Senator Riegle propounded six questions concerning consumer health warnings and related questions. These questions were printed in the Congressional Record on June 12, 1979, with a request for public response. In addition, Senator Riegle mailed approximately 200 letters to individuals and organizations concerned with alcohol-related problems requesting responses to these questions. This staff report summarizes the responses to these questions and discusses the legislative, bureaucratic, and political background of this issue. It was compiled by Craig Polhemus, Subcommittee Counsel and Staff Director, and Nancy Olson, professional staff member, with the assistance of Ruth Kane.

II. ANALYSIS OF RESPONSES

In order to supplement the public record of the BATF proceedings and the Subcommittee's 1978 hearing, Senator Riegle requested comments on consumer health warning for alcoholic beverages and related issues through a statement in the Congressional Record on June 12, 1979, and through letters to leaders in the alcoholism field and representatives of the alcoholic beverage industry. The six questions posed by Senator Riegle were:

1. Would warning labels be effective in raising public awareness of the health hazards involved in the use of alcohol?

2. Should such warning labels, if any, be of a general nature, or should they address specific dangers such as the fetal alcohol syndrome, driving impairment, etc.?

3. Should Congress consider requiring a rotating system of labeling? For example, Congress could require that 10 percent of the labels contain a warning about the fetal alcohol syndrome, 10 percent on driving impairment, etc.

4. Should such warning labels be required on beer and wine as well as distilled spirits?

5. Should beer and wine containers be required to indicate the percentage of alcohol per volume?

6. Should warning labels also be required on advertisements of alcoholic beverages?

Of the more than 250 responses received by the Subcommittee, those favoring warning labels outnumber those in opposition by better than two to one. Many letters and postcards were clearly inspired by articles in alcoholism publications, while others appeared to reflect industry efforts against the proposal.

Organizational support for warning labels was expressed by the Department of Health, Education, and Welfare; the American Medical Association; the National Association of State Alcohol and Drug Abuse Directors; the Salvation Army; the National Association of Alcoholism Treatment Programs; the National Association of Alcoholism Counselors; the American Business Men's Foundation; Women for Sobriety, Inc.; the Association of Halfway House Alcoholism Programs of North America; the Christopher B. Smithers Foundation; the Psychiatric Institute; and the Alcohol and Drug Problems Association of North America.

Organizations writing in opposition to warning labels were the Distilled Spirits Council of the United States, Inc.; the U.S. Brewers' Association; the Wine Institute; the Health Education Foundation; the National Licensed Beverage Association; the American Council on Alcoholism; Volunteers of America; and the North Conway Institute. Before reviewing the organizational and individual responses to these questions, a review of the alcoholic beverage industry's efforts to combat alcohol abuse seems in order.

The Distilled Spirits Council of the United States, Inc., in April of 1979 distributed a brochure describing its support of programs designed to combat alcohol abuse problems. This support includes such items as:

1. A public education effort focusing on the related concepts of responsible drinking and responsible decisionmaking. The outreach includes the use of major magazines, network television and radio, mass transit car cards, newspapers, motion pictures, posters, mass distribution wallet cards, and pamphlets.

2. DISCUS is working with the National Football League and the Education Commission of the States in a special program focused on young people and based on the findings of ECS's three-year Task Force on Responsible Decisions About Drinking. In 1978, this report included: 30-second and 60-second television spots starring Rocky Bleier and Drew Pearson; print ads in Pro magazines distributed at every stadium; radio messages used by the CBS Network; messages on stadium scoreboards; a new booklet, Winning Decisions, written by the Commissioner of Education from Rhode Island; and special NFL schedules featuring guidelines for responsible use or non-use of beverage alcohol.

3. Public service print advertising: Using ads developed in cooperation with Playboy magazine, DISCUS has requested magazines to donate public service space. In 1978, the following magazines carried one or more of the six DISCUS messages: Playboy, New Times, National Lampoon, Penthouse, Business Week, Psychology Today, and Atlanta Gazette.

Ladies' Home Journal, Omni, Esquire, Industry Week, and the CBS Special Interest Publications, including Road & Track, pledged to run one or more ads in 1979.

Major exposure of these messages was achieved through saturation mass transit coverage arranged by the TDI/Winston Network agency on vehicles in New York, Washington, Philadelphia, Oakland, Pittsburgh, Minneapolis/St. Paul, Atlanta, and Miami. A special pamphlet containing four of the new messages was distributed on fifty college campuses in the spring of 1978.