Any decision reached on the central question of warning labels must be founded on sound public health policy whose essential

criteria include:

1. objective research determining with quantified precision the existence of the problem and its exact nature;

2. determination of the percentage of the population affected by any problem;

3. reliably validated demonstrations to establish the most effective ways to reach the problem population.

These criteria have not been met by those who advocate warning labels on alcohol beverage containers.

Nancy Lee Hall, a recovered alcoholic mother (who noted that she had seven children, none of whom suffered from the fetal alcohol syndrome) and author of A True Story of a Drunken Mother (Daughters, Inc., 1974), also submitted a statement to the Subcommittee. With respect to warning labels, her statement said:

If a label is put on a bottle of alcohol that reads: "Heavy drinking may damage your baby", think of a woman who has a couple of drinks or even gets drunk. She may not be an alcoholic. If her baby is born with a defect, she could be trapped into feeling guilty the rest of her life. And what if the children found out about FAS? The guilt is passed on with some very uneasy thoughts: "What if my fingers are short because my mother drank alcohol?" I dread to think of the far reaching effects.

The FAS research perpetuates the victimizing of women in the name of scientific research. We are human beings, not rats. Allow me to present a hypothetical situation.

Suppose you picked up a bottle of Jack Daniels and the label read: "Warning: Heavy drinking may cause male impotency"?

Deformities used to be the mark of the devil. Are they to become the legacy of the drinking women? When will women be free in a free land?

Floyd E. Bloom, M.D., director of the Arthur V. Davis Center for Behavioral Neurobiology at the Salk Institute, forwarded a copy of a letter to Rex Davis at BATF:

It has recently been brought to my attention that you are considering the issuance of a labeling requirement for alcoholic beverages which would warn expectant mothers against excessive alcohol consumption which may place their fetuses in physical and mental jeopardy. As a researcher in this field and as the Scientific Director of an Alcohol Research Center investigating the Fetal Alcohol Syndrome, I would like to be noted as favoring a full public hearing on such a warning being issued and would speak in favor of the issuance.

In my review of the world literature, there is no duobt that physical and mental abnormalities occur with abnormally high incidence in women with documented alcoholic consumption. There is considerable evidence to support the view that

even a limited exposure to alcohol at critical stages of fetal
development could be enough to cause such abnormalities.
While much more experimental work will be required to de-
termine the precise nature of the presumed cause-effect rela-
tionship between alcohol, alcoholism, and fetal abnormalities
in humans, there is no doubt in my mind that substantial gains
for our nation's health could be gained from the hearings
and the eventual labeling than would be lost from the possi-
bility that such public hearings would exonerate alcohol as a
provocative agent in this syndrome.

As I understand it, some forces in the field have argued that alcoholics would not be dissuaded by a bottle warning, just as it may be arguable whether nicotine addicts are dissuaded by warnings on cigarette packs. However, this is fallacious logic in my view since the stronger effects would likely be directed to those who have not yet acquired these injurious habits and may be prone to do so, and could certainly serve as a counterbalance to the millions of dollars spent advertising alcoholic beverages with no indication of adverse effects. At a minimum, the hearing would again serve to call this serious matter to greater public attention.

Further, under the heading of "other aspects," may I also express my opinion that a general statement restricted to the warning of pregnant women to protect them against fetal alcohol syndrome, might imply that this was the only recognized danger of excessive alcohol consumption. In contrary there is also available from the NIAAA strong evidence of gastro-intestinal, hepatic and cardio-vascular complications of excessive alcohol consumption, and it would be more accurate-in my view-to add the warning that "alcohol consumption can be hazardous to health."

David W. Smith, M.D., professor of pediatrics and head of the dysmorphology unit at the University of Washington School of Medicine, also submitted a copy of his letter to Commissioner Davis:

I strongly commend and support your preventive program to warn women of the hazards of alcohol exposure to the developing embryo and fetus. A broad-based program of public education is merited. This should, I believe, include warning labels on all containers of alcoholic beverages. The following is a consideration for such a label:

Warning: Alcohol has been shown to be hazardous to the unborn baby and should be limited throughout pregnancy, especially the first few months after conception....

Alcohol may be clearly designated as the most common major teratogen presently recognized in our population. It may also be stated as being the most common preventable recognized cause of mental deficiency in our population.

If ethanol had been introduced 5 years ago as a medication, it would have probably been withdrawn from the market following the recognition of its teratogenicity in man and the support for this in the animal studies. Obviously, alcohol will

not be withdrawn from the market. However, it seems thor-
oughly rational and responsible to inform women of the
hazard which alcohol can cause for the unborn baby and to
emphasize that the most critical era is during the first few
months after conception. During this early phase a woman
often does not realize she is pregnant. It seems thoroughly
responsible to place such a warning on the containers of
alcoholic beverages. I believe this would be especially im-
portant at this time. Hopefully, within another 5 to 10 years
the concern about alcohol exposure to the unborn baby will
be widespread and in another generation such concern will be
accepted as "an old wives' tale."

I believe that the warning of women as to the hazard of
alcohol exposure by the unborn baby is a matter of kindness.
The huge majority of women do not wish to cause any harm
to their unborn baby. It has been a severe blow when the
mother of a child with the Fetal Alcohol Syndrome has real-
ized that her heavy intake of alcoholic beverages was the
cause for the problem in the development of her child. I recall
one woman who was a heavy cigarette smoker as well as being
alcoholic. Before becoming pregnant she sought counsel from
her physician during the era before Fetal Alcohol Syndrome
was an accepted disorder. He told her that cigarette smoking
could affect the growth of the unborn baby but that no prob-
lem had been recognized from alcohol exposure. The women
stopped smoking but continued drinking. The baby had the
Fetal Alcohol Syndrome. The woman is severely upset and
guilt-ridden.

Should society be concerned? I believe we should. As mentioned above, I believe it is a responsible concern and education as to the risks is the kindest approach. However, at a very pragmatic level society should be concerned in terms of prevention of one more cause for mental deficiency and also prevention of one cause of public welfare problems. The problems of brain function and physical growth of children with the Fetal Alcohol Syndrome have been permanent problems. Well over half of the affected children we have evaluated have become wards of the state, as foster care children. They usually require special education and many will not be able to achieve an independent life. Thus, society tends to assume the burden of the care and special education for many of the individuals with the Fetal Alcohol Syndrome. Aside from considerations of kindness to the woman and prevention of problems which require heavy public support, the major concern is, of course, the quality of life for the individual. Ideally, we would like to assure that an individual is born with the capacity to achieve his or her genetic endowment for growth and performance. Unfortunately, alcohol can cause incomplete and abnormal prenatal development and can thus prevent the full expression of an individual's genetic endowment and thereby limit the quality of his or her life.

One final statement submitted to the Subcommittee came from Thomas N. Walker, vice president and executive director of the Amer

ican Council on Alcoholism, Inc. The American Council on Alcoholism (not to be confused with the National Council on Alcoholism) noted that it is:

the only national voluntary health agency devoted exclusively
to alcoholism programs at the local level which will not ac-
cept state or federal funding, but is supported entirely by
private contributions. It is, therefore, not bound by political
or other vested interest and is able to concentrate independ-
ently on finding solutions for alcoholism and related prob-
lems working through the cooperation of its numerous mem-
ber affiliates across the country.

By refusing public funds, ACA naturally relies heavily on funds supplied by the alcoholic beverage industry.

ACA was quick to respond when NIAAA issued its conservative health caution concerning the fetal alcohol syndrome:

At that time we expressed concern that the comparison of alcohol to the harmful effects of thalidomide is creating a horror-story that is not based upon scientific knowledge, research or data.

We emphasized that Dr. Noble and the NIAAA did not endorse an abstinence policy for pregnant women, because there is not clear-cut scientific data to support such conclusions.

Today we hold the same position. In fact, major studies throughout this country and in other international studies have indicated that small quantities of alcohol ingested daily are actually beneficial to the human system.

With regard to warning labels, we concluded that there is not the scientific evidence available to merit such action. For 25 years many reputable organizations and individuals have strived to remove the stigma from alcoholism and to establish it as a "respectable" disease. Public perception of the health related aspects of alcoholism is in a delicate balance. To have that balance destroyed by a program of warning labels that is directed at heavy drinkers and thereby also promote misunderstanding in light drinkers, for which there is no evidence, would be a major tragedy.

If the ACA and other opponents of health labeling are truly concerned with removing stigma from alcohol use, perhaps it would be logical for them to support clarification of the judicially created confusion concerning the application of Food and Drug Administration labeling requirements which apply to all other foods and beverages. So long as alcohol is said to be exempted from these general requirements and isolated in a "Bureau of Vices” with tobacco and guns, it may be more stigmatized by the Federal government than it would be by factual health statements such as those commonly required for other foods and drugs.

V. FDA JURISDICTION OVER ALCOHOL LABELING

On April 11, 1940, four months after the effective date of the Federal Food, Drug, and Cosmetic Act of 1938, the Food and Drug Ad

ministration published Trade Correspondence No. 224, which declared:

While we have indicated that cordials, liquors, wine, and whiskey are subject to the Act, we will continue as in the past to leave the regulation of the labeling of these alcoholic beverages under the more specific Federal Alcohol Administration Act.

While beer is classed as food under the Act and would, therefore, be subject to the adulteration and misbranding provisions of that Act when shipped within its jurisdiction, we expect to continue our policy of not duplicating the work of the Federal Alcohol Administration with respect to the labeling of such products. That Administration, as you know, is charged with the enforcement of specific legislation dealing with alcoholic beverages.

Over the years, FDA, the Treasury Department, and at least one Federal court recognized the jurisdiction-albeit seldom invoked-of FDA over the adulteration and misbranding (labeling) of alcoholic beverages. Then, on August 31, 1976, Senior District Judge James F. Gordon of the Western District of Kentucky issued a memorandum opinion in the case of Brown-Forman Distillers Corp. v. Mathews, 435 F. Supp. 5, acknowledging FDA's jurisdiction over adulteration of alcoholic beverages but ruling that the agency had no authority over their labeling.

The case arose when, in response to a BATF decision to withdraw proposed ingredient labeling regulations which had been developed pursuant to a Memorandum of Understanding between the two agencies, the FDA issued a ruling indicating that it intended to assume enforcement of the ingredient labeling requirements of the Federal Food, Drug, and Cosmetic Act with regard to alcoholic beverages.

In reaching his decision that the term "food" as used in the FFDCA included alcoholic beverages for purposes of adulteration but not for purposes of misbranding, the District Judge acknowledged that the term appeared to reach these beverages:

We agree with the defendants that the "plain meaning" of the definition of food under the 1938 Act includes alcoholic beverages. Unfortunately, given the facts of this case the "plain meaning" of the word "food" contributes little to our understanding of whether Congress intended the BATF to have exclusive jurisdiction over the labeling of alcoholic beverages or whether Congress intended BATF and FDA to have concurrent jurisdiction in that area. We also concede that Congress did not explicitly exempt alcoholic beverages from the purview of the 1938 Act, as it did "meat and meat products." 21 U.S.C. § 392 (a). In addition we concur with the defendants that no provision in the 1938 Act limits the FDA's authority over alcoholic beverages to enforcing the adulteration and not the misbranding (labeling) sections of the Act. Notwithstanding our agreement with these statements we are fully convinced that it was Congress' intention