HEALTH CLAIMS IN THE LABELING AND ADVERTISING
OF ALCOHOLIC BEVERAGES
Distilled Spirits Plants, Wineries, Brewers, Wholesalers and
Importers of Alcoholic Beverages, and Others Concerned:
PURPOSE. The purpose of this circular is to announce the
position of the Bureau of Alcohol, Tobacco and Firearms (ATF) with
respect to health claims made in the labeling and advertising of
alcoholic beverages. This circular also announces ATF's intention
to engage in rulemaking on this subject, so as to develop more concrete
guidelines with respect to health claims in the labeling and advertising
of alcoholic beverages.
BACKGROUND. ATF has received many inquiries regarding the
inclusion on wine labels and in wine advertising of statements which
make therapeutic or curative claims or which otherwise attribute
positive effects to the consumption of wine. Under the FAA Act,
27 U. S. C. $205( e) and (f), ATF is authorized to issue regulations
on the packaging, labeling, and advertising of alcoholic beverages
as will prohibit deception of the consumer, and will prohibit, irrespective
of falsity, such statements relating to analyses, guarantees, and
scientific or irrelevant matters as are likely to mislead the consumer.
Under these regulations, labels and advertisements are prohibited
from containing any statement, design, representation, pictorial
representation, or device representing that the use of distilled
spirits, wine, or malt beverages has curative or therapeutic effects
if such statement is untrue in any particular or tends to create
a misleading impression.
Lacking substantial evidence to the contrary, ATF and its predecessor
agencies have historically taken a very strict view of the regulatory
prohibition on curative or therapeutic claims about alcoholic beverages.
This view is based on the fact that distilled spirits, wine, and
malt beverages are, in reality, alcoholic beverages and not generally
recognized as medicines.
ATF views statements which make claims regarding health benefits
associated with alcoholic beverage con-sumption as making therapeutic
or curative claims. ATF believes that any claim which sets forth
only a partial picture, representation, or truth is as likely to
mislead the consumer as those that are actually false. A state-ment
which attributes positive health benefits to the moderate consumption
of alcoholic beverages, even if backed up by medical evidence, may
have an overall misleading effect if such statement is not properly
qualified, does not give all sides of the issue, and does not outline
the categories of individuals for whom any such positive effect
would be outweighed by numerous negative health effects.
Furthermore, ATF believes that its traditional policy regarding
health claims on labels has been reinforced by the 1988 enactment
of the Alcoholic Beverage Labeling Act (ABLA), 27 U. S. C. $213
et seq. T h e A B L A contains a declaration of policy and purpose
which states that the Congress finds that "the American public should
be informed about the health hazards that may result from the consumption
or abuse of alcoholic beverages, and has determined that it would
be beneficial to provide a clear, nonconfusing reminder of such
hazards, and that there is a need for national uniformity in such
reminders in order to avoid the promulgation of incorrect or misleading
information and to minimize burdens on interstate commerce." 27
US .C. $ 2 13. As a result of this concern, the ABLA requires that
any alcoholic beverage container held for sale or distribution in
the United States must bear the following statement on the label:
GOVERNMENT WARNING:
(1) According to the Surgeon General, women should not drink
alco-holic beverages during pregnancy because of the risk of birth
defects.
(2) Consumption of alcoholic beverages impairs your ability to
drive a car or operate machinery, and may cause health problems.
It is clear that one of the purposes of the ABLA was to avoid
confUsing the American public about the health hazards associated
with the consumption of alcoholic beverages. In order to effectuate
this goal, Congress pre-scribed specific language which must appear
on the labels of alcoholic beverage products. It is ATF's position
that to the extent that the overall message of any health daim is
inconsistent with the message of the health warning statement, then
it may result in label information which is misleading and confusing
to the consumer, and which would thus be prohibited under the FAA
Act.
ATF does recognize that there is currently a growing body of scientific
research and other data that seems to provide evidence that lower
levels of drinking decrease the risk of death from coronary artery
disease. However, as a result of the most recent advice from the
Department -of Health and Human Services, ATF has also been advised
that there are numerous negative health tradeoffs that must be considered
in the formulation of any policy surrounding the dissemination of
such information.
Several questions are presented by these recent studies. The first
is whether the studies represent isolated findings, or whethir there
is significant agreement within the scientific and medical communities
with respect to these findings. If there is such agreement, the
next issue is whether such a health benefit claim would be misleading
unless it was further qualified by information regarding the adverse'effects
of alcohol consumption. Finally, the question has been raised as
to whether any type of health claim should ever be allowed in the
labeling and advertis. ing of alcoholic beverages, due to the inherent
dangers associated with these products.
Due to the complex scientific nature of these claims, ATF arranged
for discussions with the Food and Drug Administration (FDA) to develop
a consultative approach for evaluating the use of these health claims
in the labeling and advertising of alcoholic beverages. ATF may,
with the consent of the department or agency affected, utilize the
services of any department or other agency of the United States
Government to the extent necessary to carry out its powers and duties
under the Federal Alcohol Administration Act (FAA Act), 27 U. S.
C. $ 202( f).
While ATF has jurisdiction over the labeling of alcoholic beverages,
the Bureau has consistently utilized the scientific and public health
expertise of FDA in approving ingredients in alcoholic beverages,
requiring label disclosure of certain substances, and in identifying
adulterated alcoholic beverages which are deemed mislabeled. In
light of the expanding universe of medical evidence dealing with
the moderate consumption of alcoholic bever-ages, and in an eff&
t to continue to draw upon the expertise of other agencies, ATF
believes it is usefbl to consult with FDA when ATF is evaluating
such health benefit claims.
ATF has determined that a more formal regulatory structure for
approving health claims on labels is desirable. FDA evaluates health
claims on food labels pursuant to its authority under the Federal
Food, Drug, and Cosmetic Act. This law was recently amended by the
Nutrition Labeling and Education Act (NLEA), Pub. L. No. 10 l-535
(1990). As amended, the law provides that a food product is misbranded
if it bears a claim that characterizes the relationship of a nutrient
to a disease or health-related condition, unless the claim is made
in accordance with certain procedures mandated by the FDA. See 21
U. S. C. $ 343( r)( l)( B). The regulations recently issued by FDA
provide that FDA will only approve a health claim when it determines,
"based on the totality of publicly available evidence" that there
is "significant scientific agreement, among experts qualified by
scientific training and experi-ence to evaluate such claims, that
the claim is supported by such evidence." 58 Fed. Reg. 2478,2533
(1993) (Q be codified at 21 C. F. R. $ 101.14( c)).
DISCUSSION. ATF recognizes that there are differences between
ATF's statutory mandate to prevent misleading statements on labels
and in advertising of alcoholic beverages under the FAA Act, and
the more specific authority given to FDA in regulating health claims
on food labels pursuant to the NLEA. However, in many respects,
the issues presented are similar. The overriding issue is whether
such health claims are false or misleading. In view of the provisions
of the FAA Act dealing with misleading statements and the health
warning provisions of the ABLA, ATF has the statutory authority
to promulgate regulations mandating criteria for the approval of
health claims on alcoholic beverage labels similar to the criteria
and procedures the FDA has adopted for approving health claims on
food labels. Such an approach would produce greater consistency
in the positions of ATF and FDA, and would provide more structured
guidance to the industry with respect to this controversial subject.
ATF also believes it would be useful to incorporate the scientific
and public health expertise of FDA in issuing these regulations.
Thus, ATF has decided that the issue of health claims made in
the labeling and advertising of alcoholic beverages should be aired
for public comment. This issue has become very controversial over
the last few years, and ATF believes it would be beneficial to solicit
comments on this issue from the medical and scientific communities,_
the alcoholic beverage industry, and consumers. In particular, ATF
will solicit comments on whether ATF regulations should incorporate
substantive standards for evaluating health claims similar to those
contained in the new FDA regulations.
Pending the initiation of rulemaking proceedings, ATF will continue
to evaluate health claims made in the labeling and advertising of
alcoholic beverages on a case-by-case basis. In its evaluation of
specific health claims, ATF will seek advice from experts outside
the Bureau regarding the truthfulness of such claims.
While advertisements are not required to have ATF pre-approval,
industry members are reminded that they may obtain advance clearance
of proposed advertising materials from ATF if they wish to do so.
It should be noted that the FAA Act not pnly prohibits false or
misleading advertising, it also prohibits statements in advertising
. which are inconsistent with any statement on the labeling of the
products advertised. 27 U. S. C. Q 205( f)( 5). It is ATF's position
that advertising which does not present a balanced picture of the
health risks associated With alcohol consumption is not only misleading,
but it is also inconsistent with the health warning statement required
to appear on every alcoholic beverage label.
ATF has received inquiries from several industry members asking
whether it would be in violation of the regula-tions to disseminate
advertising materials which included the full text of the April
1992 edition of Alcohol Alert, which is published by the National
Institute On Alcohol Abuse and Alcoholism (NIAAA) of the Public
Health Service. This edition consists of an article and commentary
on the subject of "moderate drinking" which present a comprehensive
overview of the risks and benefits associated with the moderate
consumption of alcoholic bever-ages. After consulting with NIAAA
on this matter, ATF has determined that the dissemination of the
full text of this publication in an advertisement would not be in
violation of current ATF regulations. If such advertisements also
contain editorializing, advertising slogans, or exhortations to
consume the product, ATF will evaluate such additional text to determine
whether or not the advertisement presents a balanced picture of
the risks associated with alcohol consumption. In addition, the
use of buttons, shelf talkers, table tents, and similar items which
excerpt any portion of the NIAAA publication, which contain health
slogans or other inferential statements drawn from this publication,
or which are based upon any other publication or article citing
the health benefits of alcohol consumption, will be closely scrutinized
to determine if they present a balanced picture of the risks associated
with alcohol consumption. ATF believes that the likelihood that
the promotional items listed above will contain bal-anced statements
is very low.
ATF's views do not necessarily represent the views of other Federal
agencies with jurisdiction over this area, such as the Federal Trade
Commission and FDA. For example, FDA has advised ATF that curative,
therapeutic, or disease-prevention claims for an alcoholic beverage
might place the product in the category of a drug under the Federal
Food, Drug, and Cosmetic Act, 21 U. S. C. $321( g)( l)( B). Furthermore,
industry members should also be cautioned that any approval from
ATF of an advertisement containing a health claim is only valid
pending the .issuance of future regulations on this subject.
Although the regulations do not currently mandate specific procedures
for the approval of health claims on alcoholic beverage labels,
ATF would remind industry members that such health claims are considered
to be misleading unless they are properly qualified, present all
sides of the issue, and outline the categories of individuals for
whom any positive effects would be outweighed by numerous negative
health effects. ATF considers it extremely unlikely that such a
balanced claim would fit on a normal alcoholic beverage label.
INQUIRIES: Questions concerning this circular should refer
to its number and be addressed to the Chief, Market Compliance Branch,
Bureau of Alcohol, Tobacco and Firearms, Washington, DC 20226.
Stephen E. Higgin
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