especially designed to create "new drinkers of alcoholic
beverages" and thus is geared to the non-drinker.

Dr. Judith Hall, a consultant to BATF on the subject of warning labels, believes that adding the warnings to advertising is also appropriate:

In addition it would be appropriate to have posters in liquor stores. Perhaps just as important as warning labels is a campaign for public education, and in particular, a campaign for pregnant women and women in child-bearing age. James E. Kelsey, M.D., an NCA Board member, thinks that a warning in advertisements should be required, but remarked

I hope that in these advertisements we can get away from the cryptic statement in black "that it may be injurious to your health." This is not enough to really catch the attention of people who are affected by this kind of advertising.

Katherine Pike, an NCA Board member and former member of the National Advisory Council on Alcohol Abuse and Alcoholism, wrote that warnings on advertisements for cigarettes have been more visible in raising the level of general public awareness than those on cigarette packages. She added that warnings in "the massive amount of alcohol beverage advertising would also increase awareness of the potential hazards of alcoholic beverages."

Stanley Gitlow, M.D., an NCA Board member, recommends that such labels on advertising should be required :

We need only look at the record of effective advertising carried out by the licensed beverage industry during the past few years (milk-type beverages, etc.), to convince even the most skeptical that there is a direct relationship between the size of the advertising dollar and the use of these beverages.

Mark Keller, editor emeritus of the Rutgers Journal of Studies on Alcohol, opposes warning labels in general but pointed out that "Aside from the conscience-quieting effect," he sees no harm in the label, and "if there is to be one, it might as well appear as uselessly in ads as on containers."

Morris Chafetz, president of the Health Education Foundation and former director of NIAAA, wrote:

Absolutely not. Policymakers live by myths and images alone. Advertising is extremely effective in establishing brand preference but does not affect behaviors that cause misuse and excesses the real issue of alcohol abuse and alcoholism. What we fail to recognize is that societies exist, e.g., the Soviet Union, which suffers serious alcoholism problems, but have no advertising whatsoever of alcoholic beverages. Advertising is a ready and visible whipping boy for those with no ideas. Sam D. Chilcote, on behalf of DISCUS, wrote that warnings on alcohol beverage advertisements

would only stigmatize all forms of drinking unfairly and
inaccurately they would not contribute effectively to sound

health communication programs. On the contrary, such la-
bels would directly conflict with the purpose and content of
balanced, comprehensive information on alcohol use and
misuse in other messages and settings.

A joint letter from representatives of the American Newspaper Publishers Association, the Magazine Publishers Association, and the National Newspaper Association wrote that their objection to Congress's imposing a health warning in alcoholic beverage advertising

is based primarily on First Amendment considerations. We
believe very strongly that the decision as to what is con-
tained in advertising messages lies in the first instance with
the advertiser. Ultimate decision on what to publish or not
publish in the pages of a newspaper or magazine rests solely
with the publisher of that publication. Our courts have firmly
held that government can never be in a position to impose
burdensome requirements or conditions on the content of non-
commercial speech; decisions in recent commercial speech
cases suggest, at the very least, that the government has an
obligation to meet a very high burden before hindering or in-
fluencing in any way the free flow of commercial information
as well.

The fact that such statements are now required in cigarette
advertising is not sufficient retort to our concern.

The letter did not indicate whether the organizations opposed other advertising content requirements imposed under the Federal Alcohol Administration Act of 1935, including proof, size of container, etc. Henry King, on behalf the Brewers, wrote that:

Inasmuch as we have opposed placing warning labels directly on the container containing the beverage you will not be shocked to hear that we are against requiring them on advertisements of alcoholic beverages as well. The purpose of brand advertising is to establish brand preference nothing more.

The brewing industry is proud of its history of responsible advertising. One indication of a commitment to this principle was the establishment, in 1955, of the Brewing Industry Advertising Review Panel "to deal with the problems of advertising held to be injurious to the industry." This distinguished panel affords a mechanism for brewers to voluntarily self-regulate its advertising within the constraints of the anti-trust laws. The basic purpose is to be of service to the general public and to encourage accountability from those who present the product to the public.

In a related project, the USBA has commissioned a 30month research study at Washington University in St. Louis, Mo., under the direction of Dr. David Pittman, the Chairman of the Sociology Department, to investigate whether there is a causal relationship between advertising and consumption.

As with all studies of this nature which USBA promotes. Dr. Pittman and his associates at the conference of this investigation will be free to publish their findings whatever they may be without interference or censorship on our part. John DeLuca, president of the Wine Institute. noted that in recent years:

It has become evident that more specife and significantly stronger standards are desired by wine advertisers to reflect the industry's concern with maximum social responsibility. The new Wine Institute Code of Advertising Standards [described above]. emphasizing the responsible use of wine, was designed to encourage continued high standards so that wine advertising may increasingly be viewed as a positive contribution to society.

Although Mr. DeLuca did not expressly support or oppose advertising warnings in his letter, the Wine Institute's fervent opposition to warning labels presumably applies to advertising warnings as well.

III. BATF's PROPOSED RULEMAKING

Although Senator Thurmond and others have proposed health warning labels for alcoholic beverages over the years, recently emerging medical evidence concerning the effects of alcohol consumed during pregnancy in producing birth defects (the Fetal Alcohol Syndrome. or FAS) sparked federal action. On November 15, 1977, Dr. Donald Kennedy, then Commissioner of the Food and Drug Administration. requested the Bureau of Alcohol, Tobacco, and Firearms to require FÁS warning labels on all alcoholic beverage containers. (As discussed below, FDA's authority to require such warning labels on its own had been clouded by a Federal district court decision in BrownForman Distillers v. Matheurs, 435 F. Supp. 5. (1976).)

BATF's Progress Report Concerning the Advance Notice of Proposed Rulemaking on Warning Labels on Containers of Alcoholic Beverages and Addendum. February 1979. summarizes the response to this FDA suggestion:

I. BACKGROUND

The Bureau of Alcohol. Tobacco and Firearms (ATF) published in the FEDERAL REGISTER on January 16, 1978, an advance notice of proposed rulemaking concerning warning labels on containers of alcoholic beverages. This advance notice requested information to assist ATF in deciding whether the current regulations should be amended to require a warning label on alcoholic beverage containers, concerning the consumption of alcohol by pregnant women and the possible resulting birth defects in their newborn infants. ATF received over 3,000 comments from consumers, special interest groups, industry, doctors, and scientific researchers. The majority of those who wrote said they were opposed to a warning label.

The majority of these comments were from consumers (2,772). Most of the consumers opposed the warning label,

particularly for wine containers. Industry members were also opposed to a warning label on the grounds that, at most, the fetal alcohol syndrome applies only to excessive users of alcohol and that the warning label would be costly and ineffective. The medical profession was divided on the issue; many practitioners felt that moderate use of alcohol during pregnancy has been beneficial while some researchers felt that there is clear evidence linking alcohol use by moderate drinkers to the fetal alcohol syndrome. Several objected, because warning labels would increase feelings of guilt by those women who had consumed alcohol during pregnancy and produced children with birth defects. A general consensus of those opposed was that it is the doctor's responsibility to advise about health hazards rather than the Government's and that any measure by the Government would constitute over-regulation. Many of the comments from doctors and consumers opposing warning labels originated from California, with at least 500 form letters coming from employees of wineries in California.

Those in favor of warning labels felt that alcohol consumption by pregnant women is potentially dangerous to their children and that a warning label would have a significant effect upon alcohol consumption by these women. They also felt that, in addition, a broad education program for pregnant women should be sponsored by both private concerns and the Government. Others, including women's groups, churches, alcoholism prevention groups, and social service agencies, thought that the proposal was a positive step forward and that a warning label would contribute to better health both for infants and for the public in general. It was also felt that consumers have a right to know what risks they are taking when they use a particular product.

Because of the conflicting and sometimes highly technical opinions offered as to the seriousness of the problem and as to the best method for approaching it, the Office of Science and Technology Policy, Executive Office of the President, was asked to evaluate the comments and evidence we received. They submitted an analysis with a recommendation that the Department employ outside, specialized consultants to assess independently the warning label proposal and other approaches that would educate the public. Subsequently, we engaged three consultants in the following fields of expertise: (a) medical genetics, (b) obstetrics and pharmacology, and (c) social policy. None of these individuals have previously been involved in research or in formulating policy about the fetal alcohol syndrome problem.

The experts are Dr. Judith Hall, a medical doctor who is a specialist in genetics and Director of the Division of Medical Genetics at Children's Orthopedic Hospital in Seattle, Washington; Dr. Sergio Fabro, a medical doctor who holds advanced degrees in biological chemistry and pharmacology, and who is Professor and Director of the Fetal-Maternal Medicine Division, George Washington University Medical

Center in Washington, D.C.; and Dr. Amitai Etzioni, a sociologist who is Director for the Center for Policy Research, New York, and now a Visiting Fellow at the Brookings Institution.

The Department provided two sets of questions for the experts, one of which was directed at the medical experts and the other at the social policy expert. Each of the experts was given copies of the comments received on the advance notice, and the record of the Senate Hearing before the Subcommittee on Alcoholism and Drug Abuse of the Committee on Human Resources, held January 31, 1978. The experts independently evaluated these materials and submitted written reports of their findings to the Department. These written reports were then sent to the National Institute on Alcohol Abuse and Alcoholism; the Food and Drug Administration; the Assistant Secretary for Health, the Department of Health, Education and Welfare; the National Academy of Sciences; and the Office of Science and Technology Policy, Executive Office of the President, for their comments.

II. SUMMARY OF EXPERTS' COMMENTS

A. Fabro report

1. Scientific Evidence. Dr. Fabro concludes in this report that the fetal alcohol syndrome does exist. He states that "a series of rather aspecific abnormalities [central nervous system dysfunction; growth deficiencies; cluster of facial abnormalities; and variable major and minor malformations] have been grouped into a 'syndrome' which shows a remarkable reproducibility in that it has been observed only in offspring of chronic alcoholic mothers." He states that some alteration in brain function, growth, and facial appearance are essential for the diagnosis of the full-blown syndrome. He believes that evidence so far indicates that, to produce the full-blown syndrome, the level of alcohol consumption must be sufficiently high to cause easily-recognizable chronic alcoholism in the mother. He also states that, while evidence indicates that with lower levels of alcohol the full-blown syndrome is highly unlikely, "some other poor pregnancy outcome (e.g., low birthweight, still birth) appears possible." He thinks further, "Prospective epidemiological studies are required to establish whether, for example, wine (2-3 glasses) with dinner or one martini before dinner taken by the mother are devoid of any toxicity for the unborn child." Dr. Fabro believes that 'the position taken by the March of Dimes in advising women about alcohol consumption and pregnancy is prudent. Until more data is accumulated in this respect, they advise any woman who is planning to become pregnant to abstain from consuming alcohol-containing beverages."

He thinks that heavy alcohol consumption by the chronic alcoholic mother appears essential for the occurrence of infants with the fetal alcohol syndrome, although the mechan