Page images
PDF
EPUB

aforementioned statutes, especially confirms Congressional
intent not to give warning label authority to BATF.

The DISCUS memorandum went on to make a strong case for FDA jurisdiction over health labeling for alcoholic beverages by undercutting the basis for BATF's authority in this field:

An examination of the FAAA labeling provisions as a
whole indicates that Congress did not intend the Secretary
of the Treasury to have the authority to prescribe regulations
concerning the effects of alcohol; instead, the FAAA only
gives the Secretary the power to enact labeling regulations
concerning the physical characteristics of the product.
All of these provisions have one aspect in common: they au-
thorize the Secretary to enact regulations to inform the con-
sumer of what is in the bottle and to prevent deception con-
cerning its contents. Nowhere in the labeling provisions of
the FAAA does it appear that the Secretary is authorized to
enact regulations concerning the possible effects of alcohol.
An examination of all sections, not just the labeling provi-
sions, of the FAAA also reveals that Congress, in enacting
the FAAA, was concerned with the physical characteristics
rather than the effects of alcohol beverages. The FAAA, it
must be remembered, was enacted in order to control the
alcohol industry after Prohibition ended. The statute as a
whole reflects the fact that control of the industry and its
products were intended, not control over the effects of alcohol.

[blocks in formation]

In summary, when one considers the labeling provisions of the FAA or the statute as a whole, it seems clear that Congress was not directing its attention to the effects of alcohol, but rather to the physical characteristics of the product (i.e., its "quality"), its efficient distribution, and deception of the consumer concerning the packaged contents. Whatever authority BATF may have to enact regulations concerning the physical attributes of the product, it does not appear after an examination of the text of the statute that Congress intended that the Secretary of the Treasury should have the authority to enact regulations concerning the possible effects of beverage alcohol.

(As the DISCUS memorandum notes in a footnote:

This is a conclusion in which the current FDA Commis-
sioner appears
to concur. In his statement submitted January
31, 1978 to the Subcommittee on Alcoholism and Drug Abuse
of the United States Senate Committee on Human Resources.
., Commissioner Donald Kennedy noted:

While the Federal Alcohol Administration Act is di-
rected at preventing fraud and deception through appro-
priate labeling and at revenue collection, FDA's statute
is directed at both prevention of public deception and
protection of public health and safety.

Statement by Donald Kennedy, Commissioner, FDA, Senate
Comm. on Human Resources, 95th Cong., 2nd Sess. (Jan. 31,
1978).)

In the wake of Brown-Forman's ruling that the BATF had exclusive jurisdiction over all labeling of alcoholic beverages, that agency properly rejected DISCUS's attempt (reminiscent of the apocryphal son who murdered both parents and then appealed for mercy on the grounds that he was an orphan) to escape first the FFDCA and then the FAAA requirements. In the agency's February 1979 Progress Report Concerning the Advance Notice of Proposed Rulemaking on Warning Labels on Containers of Alcoholic Beverages and Addendum, announcing deferral of a decision on whether to require a fetal alcohol warning, BATF stated:

One option which has been considered is to require a warning label concerning the risks of alcohol for the pregnant woman on all alcoholic beverage containers. The Department believes that adequate statutory authority exists for such a requirement and that, in many cases, labeling has served as a vehicle for communication. Such an approach would bring some information about this issue to the attention of large segments of the drinking population.

BATF has indicated that a decision on whether to require an FAS warning label will be made after evaluating the effectiveness of other techniques, such as those voluntarily supported by the alcoholic beverage industry.

IV. SUBCOMMITTEE HEARING, JANUARY 31, 1978

During the 95th Congress, the Subcommittee on Alcoholism and Drug Abuse held a hearing on January 31, 1978, on "Alcohol Labeling and Fetal Alcohol Syndrome". The hearing report presented oral testimony from 13 witnesses and written statements from dozens of others.

The first witness was Senator Strom Thurmond, who had introduced a bill in the 95th Congress similar to his amendment added to S. 440 in the 96th:

When I introduced this legislation for the first time in 1972, I proposed a warning on all bottles containing 24 percent alcohol.

At that time, I felt that to mandate a warning on so-called hard liquors would be an adequate step toward public awareness of the health hazards of alcohol. The warning read "Caution: Consumption of alcoholic beverages may be hazardous to your health and may be habit forming." In the past 6 years, significant research has demonstrated the inadequacy of my prior proposal. Statistics confirm that the youthful drinker most often begins his drinking with beer. The dangers associated with fetal alcohol syndrome can be precipitated by excessive use of beer or wine, as well as stronger alcoholic beverages. In fact, the Food and Drug Administration's proposal in reference to warning labels recommends the inclusion of all alcoholic beverages in warning requirements. In light of these facts, I believe that a health warning on all alcoholic beverages is necessary. The warning which I proposed will read: "Caution: Consumption of alcoholic beverages may be hazardous to your health, may be habit forming, and may

cause serious birth defects when consumed during
pregnancy.".

A health warning like the one I am proposing will be an effective method of keeping the public constantly aware of the dangers of alcohol, and encouraging responsible decisions with respect to alcohol consumption. If this warning deters one potential alcoholic from taking his first drink, if it encourages one expectant mother to refrain from or substantially moderate her drinking habits, or if it makes a casual drinker, who drives, stop and think before having "one for the road," then this legislation will be effective and worthwhile.

In response to questions from Senator William Hathaway, then Chairman of the Subcommittee on Alcoholism and Drug Abuse, Senator Thurmond endorsed requiring the same warning in print and broadcast advertising.

Dr. Gerald Klerman, Administrator of the Alcohol, Drug Abuse, and Mental Health Administration, testified concerning the fetal alcohol syndrome and a "health caution" issued on June 1, 1977, concerning the risks of drinking during pregnancy, which read in part :

While safe levels of drinking are unknown, it appears that a risk [of the fetal alcohol syndrome] is established with ingestion above 3 ounces of absolute alcohol or 6 drinks per day [during pregnancy]. Between 1 ounce and 3 ounces, there is still uncertainty but caution is advised. Therefore, pregnant women and those likely to become pregnant should discuss their drinking habits and the potential dangers with their physicians.

After discussing the confusion over FDA's authority to order warning labels, FDA Commissioner Donald Kennedy testified about the need for such warnings on alcoholic beverages:

I can see no legitimate argument against providing warning labeling if a scientific basis for it is found as we believe it to be in this case.

We get a lot of arguments, Mr. Chairman, that warning labeling is not effective. Many of them stem, as you have heard, from some presumptions about how well the warning labeling on cigarettes has worked.

I would only reiterate that those data are very, very hard to interpret. Like Senator Thurmond, from whom you heard earlier, I think that the information about smoking behavior in adult males in the U.S. adult population can be interpreted to yield the conclusion that, in fact, warning labeling has been significantly more effective than no labeling would have been.

In any event, it is an uncontrolled experiment. Just as it is
impossible to convince people who do not want to be convinced
that warning labeling did work, so it is not reasonable to draw
from cigarette experience the conclusion that warning label-
ing does not work.

In any event, I think it is the wrong question to be asking.
It seems to me that it is impossible to become too absorbed in

the matter of whether warning labeling works, that is,
whether we can judge by our rather crude methods that there
has been a massive shift in behavior by the entire population.
Suppose such shifts cannot be detected after we apply warn-
ing labeling. Does that mean labeling is not a good idea? I
think not for two reasons.

First of all, people who decide what behavior to adopt in
place of the warning label may choose to take the risks, but at
least they have done so on an informed basis.

Second, and perhaps more important, wherever there is a special population at risk, as pregnant women, it seems to me that the Government has an obligation to inform that population of the special risk, and that that obligation exists independently of the sort of prior efficacy judgment one makes about the warning.

Even if only a small number of people change their behavior, it seems to me that those people have a right to know what the Government had legitimately concluded about scientific evidence of risk. Even if only 1 percent of them opt for that change, it seems to me that the Government's obligation is nonetheless clear.

Like Senator Thurmond, Commissioner Kennedy responded to Senator Hathaway's questioning by endorsing extending the warning requirement to advertising as well as labeling.

Senator Hatch, ranking minority member of the Subcommittee, asked the HEW panel the following question:

Senator HATCH. What you seem to be saying is although studies are still ongoing they are conclusive enough at this time to really in your opinion mandate warning labels on alcoholic beverages or at least strongly suggest that that would be an effective way of going at this time?

Dr. KLERMAN. Both the FDA and the National Institute on Alcohol Abuse and Alcoholism and [the Alcohol] Drug Abuse, [and Mental Health] Administration are together of the opinion that evidence has reached a sufficient degree of conclusion that it is a public health hazard, and we recommend that you act.

In response to questioning by Senator Hathaway, Dr. Kennedy also addressed the question of a specific versus a general health warning:

Dr. KENNEDY. Well, Senator Hathaway, I tend to believe, for no very good reason, that specific warnings work a little better than general ones.

I think it is clearly true that alcohol is a general health hazard and I would welcome, I think, a general warning but underscore and reinforce that, because I think everybody ought to be concerned about it.

But here we have a population at very special risk and I I think there is a special obligation to inform them of that risk.

[blocks in formation]

So my chief interest at the moment is a specific one. Senator HATHAWAY. Except, I suppose, that has the effect of people saying if they are not pregnant or never become pregnant, that alcohol will not bother them.

Dr. KENNEDY. I suppose that is a possible reaction.

If many people have it, I would be concerned.

I would think a more sensible reaction would be, if a delicate biological system like developing infants is so sensitive to this, and it presents that kind of health hazard, it might not be terribly good for my physiology, either.

I would hope that most people would react that way.

State Senator Bennett D. Katz of Maine testified as vice chairman of the Task Force on Responsible Decisions About Alcohol of the Education Commission of the States and chairman of the Education Committee of the Maine State Senate. He said:

Certainly, a warning label on alcoholic beverages, if read, will call attention to the reader that the product can be misused. But, on behalf of the task force, may I raise some questions that we believe to be related to this issue.

What have we already learned about warning labels?

In listening to testimony this morning, we are not sure what we have learned. I am not sure that labels will reduce alcohol-related problems. . . .

If we decide to place warning labels on alcoholic beverages, is it not incumbent upon us also to place warning labels on all products that, when used excessively or inappropriately, may be harmful. Carried to its extreme, we may well need to consider labeling everything in our environment, except Maine lobsters.

Mr. Katz then engaged in the following colloquy with Senator Hathaway:

Senator HATHAWAY. I take it your position is to go ahead and label, but it is not going to do much good?

Mr. KATZ. I guess so.

You remember, this is my eighth term. I become more and more humbled, I become more and more impatient with trying to solve societal problems with passing another law.

The next panel consisted of Richard J. Davis, Assistant Secretary of the Treasury for Enforcement and Operations, and Rex D. Davis, then Director of the Bureau of Alcohol, Tobacco, and Firearms and now president of the National Association of Alcoholic Beverage Importers. (Such career moves are common in the alcoholic beverage regulation field. During hearings on the proposed FAAA in 1935, the Senate Finance Committee dealt with a similar possibility of an appearance of impropriety on behalf of the prohibition-era Commissioner of Industrial Alcohol, who, upon repeal, became supervisor of the Distillers Code Authority which drafted the code to regulate the distilling industry, and then went on to head the Distilled Spirits Institute.)

« PreviousContinue »