EXECUTIVE SUMMARY

I. On May 7, 1979, the Senate passed an amendment requiring a health warning label on alcoholic beverages containing more than 24 percent alcohol. Senator Donald W. Riegle, Jr., Chairman of the Subcommittee on Alcoholism and Drug Abuse, requested comments on consumer health warnings for alcoholic beverages and related issues and scheduled a hearing for September 14, 1979. (Introduction, I.) II. Of the more than 250 comments received by Senator Riegle, those in favor of warning labels outnumber those opposed by better than 2 to 1. Organizational support 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 Abuse 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.

The alcoholic beverage industry deserves praise for its alcoholism prevention activities, which include support for many constituency organizations and individuals. The industry and many of those it supports strongly oppose warning labels.

Question 1. Although some respondents indicated that warning labels would not deter alcoholics from drinking, others wrote that warnings would help prevent such addiction and other health problems from arising, as well as enabling consumers to make informed decisions. A few alcoholism specialists expressed fear that labels would stall progress toward comprehensive solutions or fail to reduce consumption, whereas others argued that they would spark additional measures and should be employed to raise awareness of health hazards, especially the fetal alcohol syndrome, whether or not they affect individual drinking decisions.

Question 2. Those favoring a general warning label feared that a specific warning might decrease attention to health hazards not mentioned in the label text. The larger number favoring specific warnings cited the fetal alcohol syndrome as the greatest concern. Others favored a combined warning incorporating both general and specific

statements.

(IX)

Question 3. Most respondents indicated that rotating warning labels would be overcomplicated, expensive, or confusing. Some were intrigued by the proposal, citing the possibility of greater visibility and effectiveness; HEW Secretary Joseph Califano cited the apparent success of rotating warning labels in reducing cigarette consumption in Sweden.

Question 4. There was almost unanimous support for extending any warning label requirements for distilled spirits to beer and wine as well.

Question 5. Except for the U.S. Brewers' Association, all respondents favored requiring beer and wine containers to indicate their alcohol content by volume.

Question 6. Generally, views on extending health warning requirements to advertisements paralleled those for package labels. Three publishers' associations expressed disapproval of advertising requirements. (Analysis of Responses, II)

III. On November 15, 1978, FDA Commissioner Donald Kennedy urged BATF to require health warning labels on alcoholic beverages warning of the risk of birth defects from alcohol consumption during pregnancy. Of the three BATF consultants hired to study this issue,

One declined to comment on whether labels should be required, but noted that relying on physicians would be inadequate to reach women of childbearing age and their partners and that the prudent course was to advise abstinence during pregnancy;

One endorsed warning labels; and

One expressed doubts about the appropriateness and effectiveness of warning labels alone but suggested that dedicated taxation of alcohol sales coupled with public posting of fetal alcohol warnings in liquor stores and prenatal clinics and other information efforts together with warning labels are likely to be more effective than any of these efforts individually.

Alcoholic beverage trade associations opposed BATF's proposed rule requiring a fetal alcohol warning label on the grounds that

Labels would be ineffective at changing behavior;

Labels would be inefficient through raising retail costs almost one cent per bottle in an attempt to prevent a substantial portion of the estimated 1,500 to 5,000 fetal alcohol syndrome births annually (and some additional number of lesser birth defects); A labeling requirement might constitute a non-tariff trade barrier;

Labels would be misleading in not mentioning possible beneficial aspects of alcohol consumption;

Imposition of a labeling requirement might delay comprehensive approaches to alcohol-related problems;

Primary reliance on physicians to inform women of the risks of drinking during pregnancy would be more appropriate, possibly supplemented with public education efforts such as classroom and community programs, government publications, and patient brochures;

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.