[Federal Register Volume 64, Number 205 (Monday, October 25, 1999)]
[Proposed Rules]
[Pages 57413-57418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27774]


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DEPARTMENT OF THE TREASURY

27 CFR Parts 4, 5, and 7

Bureau of Alcohol, Tobacco and Firearms
[Notice No. 884]
RIN 1512-AB97


Health Claims and Other Health-Related Statements in the Labeling 
and Advertising of Alcohol Beverages (99R-199P)

AGENCY: Bureau of Alcohol, Tobacco and Firearms (ATF), Department of 
the Treasury.

ACTION: Notice of proposed rulemaking.

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SUMMARY: ATF is proposing to amend the regulations to prohibit the 
appearance on labels or in advertisements of any statement that makes a 
substantive claim regarding health benefits associated with the 
consumption of alcohol beverages unless such claim is properly 
qualified, balanced, sufficiently detailed and specific, and outlines 
the categories of individuals for whom any positive health effects 
would be outweighed by numerous negative health effects. ATF is also 
proposing to prohibit any advertisements that attribute health benefits 
to the consumption of alcohol beverages unless such statement is 
appropriately qualified in a manner that is not likely to result in any 
consumer confusion or deception. This notice seeks comments on whether 
the negative consequences of alcohol consumption or abuse disqualify, 
as misleading, these products entirely from entitlement to any health-
related statements. This notice also seeks comments on whether health-
related statements on alcohol beverage labels and advertising directing 
consumers to sources, such as the U.S. Government Dietary Guidelines, 
of information are misleading and whether ATF should continue to 
approve such statements.
    The proposed regulations are intended to ensure that labels and 
advertisements do not contain statements or claims that would tend to 
mislead the consumer about the significant health consequences of 
alcohol consumption.

DATES: Comments must be received on or before February 22, 2000.

ADDRESSES: Send written comments to: Chief, Regulations Division; 
Bureau of Alcohol, Tobacco and Firearms; P.O. Box 50221; Washington, DC 
20091-0221; ATTN: Notice No. 884. Submit e-mail comments to: 
[email protected]. E-mail comments must contain your 
name, mailing address, and e-mail address. They must also reference 
this notice number and be legible when printed on not more than three 
pages 8\1/2\''  x  11'' in size. We will treat e-mail as originals and 
we will not acknowledge receipt of e-mail.

FOR FURTHER INFORMATION CONTACT: James P. Ficaretta, Regulations 
Division, Bureau of Alcohol, Tobacco and Firearms, 650 Massachusetts 
Avenue, NW., Washington, DC 20226 (202-927-8230).

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 
205(e) and (f), we are authorized to issue regulations on the 
packaging, labeling, and advertising of alcohol beverages in order to 
prohibit deception of the consumer and, without regard to their truth 
or falsity, statements relating to analyses, guarantees, and scientific 
or irrelevant matters that are likely to mislead the consumer.
    Regulations that implement the provisions of section 205(e) and 
(f), as they relate to the labeling and advertising of wine, distilled 
spirits, and malt beverages, are set forth in Title 27, Code of Federal 
Regulations (CFR), parts 4, 5, and 7, respectively. Under these 
regulations, labels and advertisements are prohibited from containing 
any statement, design, representation, pictorial representation, or 
device representing that the use of wine, distilled spirits, or malt 
beverages has curative or therapeutic effects if such representation is 
untrue in any particular or tends to create a misleading impression. 
This prohibition originated more than 60 years ago with the initial 
labeling and advertising regulations issued under the FAA Act.
    ATF and our predecessor agencies have historically taken a very 
strict view of the regulatory prohibition on curative or therapeutic 
claims about alcohol beverages. This strict interpretation is based on 
the view that ``distilled spirits, wines and malt beverages are, in 
reality, alcoholic beverages and not medicines of any sort, * * *'' 
(FA-129, dated January 5, 1938).
    In view of the undisputed health risks associated with alcohol 
consumption, it has always been our position that statements 
attributing positive health effects to the consumption of alcohol 
beverages are misleading unless such statements are appropriately 
qualified and properly balanced.

II. Our Existing Policy Regarding Health Claims and Other Health-
Related Statements--Summary

    The following is a summary of our existing policy with respect to 
health claims and other health-related statements in the labeling and 
advertising of alcohol beverages.
    We view statements that make substantive claims regarding health 
benefits associated with alcohol beverage consumption as making 
therapeutic or curative claims. Claims which set forth only a partial 
picture or representation might be as likely to mislead the consumer as 
those that are actually false. A claim which is supported by scientific 
evidence may still mislead the consumer without appropriate 
qualification and detail. Any such claim is considered misleading 
unless it is properly qualified, balanced, sufficiently detailed and 
specific, and outlines the categories of individuals for whom any 
positive health effects would be outweighed by numerous negative health 
effects.

III. Negative Consequences of Alcohol Consumption

    The risks associated with alcohol consumption are well-documented.
    In an article entitled ``Alcohol and Risk of Coronary Events,'' \1\ 
Charles H. Hennekens, M.D. outlines these risks as follows:

    * Endnotes to preamble appear at end of article.

    The hazards of heavy alcohol consumption are clear and 
substantial and have far-reaching health and social consequences. 
Alcohol is the second leading cause of preventable deaths in the 
United States as well as most industrialized countries, second only 
to cigarette smoking. Drinking increases the risk of cancer of the 
liver, mouth, tongue, and esophagus and has been implicated as a 
cause of 3 to 5 percent of all cancer deaths. Heavy alcohol 
consumption is also associated with increased risks of hemorrhagic 
stroke and cardiomyopathy, and it predisposes to hepatic cirrhosis, 
the ninth most common cause of death in the United States. In 
pregnant women, heavy alcohol consumption is associated with fetal 
alcohol syndrome. Alcohol drinking is also implicated in over 40 
percent of all fatal traffic crashes, which are a chief cause of 
premature deaths in younger people, and it is associated with 
suicides, industrial accidents, sex crimes, robberies, and murders. 
It is estimated that 14 million U.S.

[[Page 57414]]

residents suffer from alcohol abuse and dependence, and 76 million 
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are affected by its presence in a family member.

    It is true that many of these health risks are caused by heavy 
levels of alcohol consumption. It is also true that there are millions 
of Americans with alcohol dependency problems who find themselves 
unable or unwilling to control their consumption of alcohol. Given the 
serious health risks associated with higher levels of alcohol 
consumption, and given the fact that most medical studies agree that 
the effects of moderate consumption differ from individual to 
individual, any claim associating health benefits with moderate alcohol 
consumption must be carefully evaluated to ensure that it does not 
mislead the consumer about the various health consequences related to 
the consumption of alcohol beverages.
    We recognize that there are several scientific studies suggesting a 
link between moderate alcohol consumption and a lower risk of coronary 
artery disease (``CAD'').\2\ However, at this time, we do not believe 
there is significant scientific evidence to support an unqualified 
conclusion that moderate wine (alcohol) consumption has health benefits 
for all or even most individual consumers. Some studies have suggested 
that only older drinkers will accrue any health benefits from moderate 
alcohol consumption.\3\ This is because younger individuals have such a 
low risk for coronary artery disease and are much more likely to be at 
risk from alcohol consumption even at lower levels. This difference in 
risk factors has been explained as follows: \4\

    The net contents of all-cause mortality associated with a 
certain alcohol consumption level therefore also depends on the 
drinker's absolute risk of dying from these various causes. 
Accordingly, older people--who are at high absolute risk of coronary 
heart disease and ischemic stroke and at low risk for injury, 
cirrhosis, and other alcohol-related diseases--are most likely to 
benefit from low levels of alcohol consumption. In contrast, for men 
and women under age 40, who have relatively low absolute risk of 
dying from strokes, heart disease, and alcohol-related diseases but 
a high absolute risk of dying from injury, all-cause mortality will 
increase even at relatively low alcohol-consumption rates * * *. 
Finally, the absolute risk of death from injury or coronary heart 
disease is lower in young women than in young men, leading to an 
increase in all-cause mortality even in young women who are light 
drinkers (less than two drinks every 3 days) compared with 
abstainers.

    Overall, the available scientific literature suggests that there 
may be serious health risks associated with heavy as well as moderate 
alcohol consumption, depending on the individual.\5\ In light of the 
negative health consequences of alcohol consumption or abuse, it is 
possible that these products may not be entitled to any health-related 
statement. As noted below in section VII, the Federal Trade Commission 
has adopted a policy that unqualified health claims on products that 
pose increased health risks are deceptive. Accordingly, we are 
soliciting comments on whether alcohol beverages should not be entitled 
to health-related statements.

IV. Industry Circular 93-8

    On August 2, 1993, we published Industry Circular 93-8. The 
circular generally restated our existing position regarding misleading 
curative and therapeutic claims, i.e., we view statements that make 
substantive claims regarding health benefits associated with alcohol 
beverage consumption as making therapeutic or curative claims. Any 
claim that sets forth only a partial picture or representation might be 
as likely to mislead the consumer as those that are actually false. 
Thus, a statement which attributes health benefits to the moderate 
consumption of alcohol beverages, even if supported by medical 
evidence, might 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.
    We also explained that our existing policy regarding health claims 
on labels had been reinforced by the 1988 enactment of the Alcoholic 
Beverage Labeling Act (ABLA), 27 U.S.C. 213 et seq. The ABLA contains a 
declaration of policy and purpose that 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 U.S.C. 213. As a result of this 
concern, the ABLA requires that any alcohol 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 alcoholic 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 alcohol beverages. In order to accomplish this goal, 
Congress prescribed specific language that must appear on the labels of 
alcohol beverage products. It is our position that to the extent that 
the overall message of any health claim is inconsistent with the 
message of the health warning statement, it may result in label 
information that is misleading and confusing to the consumer and would 
be prohibited under the FAA Act.
    In Industry Circular 93-8, we further noted that other Federal 
agencies, such as the Food and Drug Administration and the Federal 
Trade Commission, may have jurisdiction over certain aspects of 
labeling and advertising issues involving health claims. We will 
address this issue further in section VII (Role of Other Federal 
Agencies With Respect to Health Claims and Other Health-Related 
Statements).
    We also stated that the distribution of advertising materials which 
included the full text of the April 1992 edition of ``Alcohol Alert,'' 
published by the National Institute on Alcohol Abuse and Alcoholism 
(NIAAA), would not be in violation of current regulations. This NIAAA 
publication provides a comprehensive discussion of the health 
consequences of moderate alcohol consumption. If such advertising 
materials also contain editorializing, advertising slogans, or 
exhortations to consume the product, we would evaluate such additional 
text to determine whether or not the advertisement presents a balanced 
picture of the risks associated with alcohol consumption. In addition, 
we stated that the use of buttons, shelf talkers, table tents, and 
similar items that excerpt any portion of the NIAAA publication, that 
contain health slogans or other inferential statements drawn from this 
publication, or that 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.
    In addition, we reminded industry members in Industry Circular 93-8 
that substantive health claims on labels 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

[[Page 57415]]

numerous negative health effects. We concluded that it would be 
extremely unlikely that any such balanced claim would fit on a normal 
alcohol beverage label. Our policy with respect to substantive health 
claims has not changed since the issuance of the industry circular. 
Finally, we stated that it was our intent to initiate rulemaking on 
this issue; however, pending rulemaking, we would continue to evaluate 
claims in labeling and advertising on a case-by-case basis.

V. Competitive Enterprise Institute Petition

    On May 9, 1995, the Competitive Enterprise Institute (CEI) 
submitted a petition asking us to issue a rule allowing alcohol 
beverage labels and advertisements to carry statements regarding the 
purported benefits of moderate alcohol consumption of alcohol 
beverages. More specifically, CEI proposed that the following language 
be permitted on labels and in advertisements: ``There is significant 
evidence that moderate consumption of alcoholic beverages may reduce 
the risk of heart disease.'' We would consider this statement to be an 
example of a substantive health claim. By letter dated January 13, 
1997, we denied this rulemaking petition stating that the specific 
health claim proposed by CEI was not appropriately qualified, was not 
balanced regarding the health consequences of alcohol consumption and, 
as such, its use on labels could mislead consumers.

VI. Dietary Guidelines

    The Fourth Edition (1995) of the ``Dietary Guidelines for 
Americans'' was published by the U.S. Department of Agriculture and the 
U.S. Department of Health and Human Services in 1996. The Guidelines 
contain a detailed discussion concerning the consequences and effects 
of alcohol beverage consumption. There have been suggestions that the 
Federal government itself, in its issuance of the Dietary Guidelines, 
has officially recognized the health benefits of moderate alcohol 
consumption. It is true that the Guidelines acknowledge that 
``[c]urrent evidence suggests that moderate drinking is associated with 
a lower risk for coronary heart disease in some individuals.'' However, 
this is not a statement of a health benefit; it is merely a conclusion 
that in some individuals, moderate drinking may be associated with a 
lower risk of coronary heart disease. The Dietary Guidelines then go on 
to discuss the ``serious health problems'' caused by alcohol 
consumption as follows:

    However, higher levels of alcohol intake raise the risk for high 
blood pressure, stroke, heart disease, certain cancers, accidents, 
violence, suicides, birth defects, and overall mortality (deaths). 
Too much alcohol may cause cirrhosis of the liver, inflammation of 
the pancreas, and damage to the brain and heart. Heavy drinkers also 
are at risk of malnutrition because alcohol contains calories that 
may substitute for those in more nutritious foods.

    The Dietary Guidelines recommend that if adults choose to drink 
alcohol beverages, they should consume them only in moderation. The 
term ``moderation'' is defined as no more than one drink per day for 
women and no more than two drinks per day for men. However, the Dietary 
Guidelines also conclude that for some people, even moderate drinking 
is not recommended. Thus, many people should not drink alcohol 
beverages at all, including children and adolescents, women who are 
trying to conceive or who are pregnant, individuals who plan to drive 
or take part in activities that require attention or skill, and 
individuals using prescription and over-the-counter medications. 
Finally, the Dietary Guidelines also suggest that individuals of any 
age who cannot restrict their drinking to moderate levels should not 
drink at all. This last category is obviously hard to define, and may 
include many individuals who do not even realize that they fall within 
this category.
    It is clear that the Dietary Guidelines explicitly recognize that 
moderate alcohol consumption is not an activity that has only 
beneficial effects to the health of the consumer. Millions of adult 
consumers fall within the categories of people who should not drink 
alcohol beverages at all. The Dietary Guidelines do not represent an 
unqualified endorsement of the health benefits of moderate alcohol 
consumption. Thus, without appropriate qualifications and explanations, 
any such statement to that effect would tend to mislead consumers. 
However, we have no objections to the dissemination of the entire 
Dietary Guidelines as advertising materials by industry members or to 
the dissemination of the two pages from the Guidelines dealing with 
alcohol beverages (pages 40 and 41).

VII. Role of Other Federal Agencies With Respect to Health Claims 
and Other Health-Related Statements

    While ATF has primary jurisdiction over the labeling and 
advertising of alcohol beverages, under certain circumstances the 
labeling and advertising of alcohol beverages may also be subject to 
the jurisdiction of the Food and Drug Administration (FDA) or the 
Federal Trade Commission (FTC). For example, since certain wine 
products containing less than 7 percent alcohol by volume are not wines 
subject to the FAA Act, the labeling of such products falls within 
FDA's jurisdiction. We have always utilized the scientific and public 
health expertise of FDA in approving ingredients in alcohol beverages, 
requiring label disclosure of certain substances, and identifying 
adulterated alcohol beverages that are deemed mislabeled.
    FDA has advised us that certain curative, therapeutic, or disease-
prevention claims for an alcohol beverage might place the product in 
the category of a drug under the Federal Food, Drug, and Cosmetic Act 
(FFD&C Act), 21 U.S.C. 321(g)(1)(B). FDA evaluates health claims on 
food labels pursuant to its authority under the FFD&C Act, as amended 
by the Nutrition Labeling and Education Act (NLEA), Public Law 101-535 
(1990). 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)(1)(B). FDA's regulations provide that FDA will only approve a 
health claim when it determines, ``based on the totality of publicly 
available scientific evidence'' that there is ``significant scientific 
agreement, among experts qualified by scientific training and 
experience to evaluate such claims, that the claim is supported by such 
evidence.'' 21 CFR 101.14(c). ATF would continue to review health-
related statements to ensure consistency with FDA's statutory and 
regulatory authorities.
    The FTC's general jurisdiction over advertising extends to alcohol 
beverages. A problem that is of particular relevance to the area of 
alcohol beverage advertising is that of the ``qualified'' health claim. 
In their policy statement, published in the Federal Register on June 1, 
1994 (59 FR 28394), the FTC stated that it is necessary to examine 
``whether qualified claims are presented in a manner that ensures that 
consumers understand both the extent of the support for the claim and 
the existence of any significant contrary view within the scientific 
community.'' We would also note that the FTC policy statement stated 
that an unqualified health claim in the advertising of a food was 
likely to be deceptive if the food also contained a nutrient that 
increased the

[[Page 57416]]

risk for another disease or health-related condition, and the risk-
increasing nutrient was closely related to the subject health claim.

VIII. Notice of Proposed Rulemaking

    We are proposing to revise the regulations to reflect our current 
policy and to provide that labels or advertisements may not contain any 
statement, design, representation, pictorial representation, or device, 
whether explicit or implicit, representing that consumption of alcohol 
beverages has curative or therapeutic effects if such statement is 
untrue in any particular or tends to create a misleading impression. A 
substantive claim regarding health benefits associated with the use of 
an alcohol beverage is misleading unless such claim is properly 
qualified, balanced, sufficiently detailed and specific, and outlines 
the categories of individuals for whom any positive health effects 
would be outweighed by numerous negative health effects.
    While industry members are not required to submit advertising 
materials to us for pre-approval, we encourage the use of our voluntary 
pre-clearance process for any advertisements that refer to the health 
effects of alcohol consumption.
    We believe that the proposed regulations will ensure that labels 
and advertisements do not contain statements or claims that would tend 
to mislead the consumer about the significant health consequences of 
alcohol consumption.

IX. First Amendment Issues

    Various members of the alcohol beverage industry have suggested 
that under the First Amendment to the United States Constitution, ATF 
is precluded from preventing the dissemination of truthful information 
about health benefits from alcohol beverage labels and advertisements. 
We are prohibiting the use of misleading statements regarding health 
claims that are by definition not protected by the First Amendment. 
Commercial speech is protected by the First Amendment only if it is 
truthful and not misleading. Central Hudson Gas & Elec. Corp. v. Public 
Serv. Comm'n of New York, 447 U.S. 557, 566 (1980). This longstanding 
position has been upheld by the Supreme Court in its most recent 
commercial speech decision. See 44 Liquor Mart, Inc. v. Rhode Island, 
1996 U.S. LEXIS 3020 (1996).

X. Footnotes Appearing in Text of Supplementary Information

    1. Hennekens, C.H., ``Alcohol and Risk of Coronary Events,'' 
Research Monograph No. 31, ``Alcohol and the Cardiovascular System'' 
at 15 (National Institutes of Health, National Institute on Alcohol 
Abuse and Alcoholism, Bethesda, MD, 1996).
    2. See, e.g., Boffetta, P. & Garfinkel, L., ``Alcohol drinking 
and mortality among men enrolled in an American Cancer Society 
prospective study, ``Epidemiology'' 1(5):343-348, 1990; Stampfer, 
M.J.; Colditz, G.A.; Willett, W.C.; Speizer, F.E. & Hennekens, C.H., 
``A prospective study of moderate alcohol consumption and the risk 
of coronary disease and stroke in women,'' ``New England Journal of 
Medicine,'' 319(5):267-273, 1988; Klatsky, A.L.; Armstrong, M.A.; 
and Friedman, G.D., ``Alcohol and Mortality,'' ``Annals of Internal 
Medicine,'' 117:646-654, 1992. See generally National Institute on 
Alcohol Abuse and Alcoholism, ``Moderate Drinking,'' ``Alcohol 
Alert,'' No. 16, April 1992, at 2, and studies cited therein.
    3. See, e.g., Criqui, M.H., ``Moderate Drinking: Benefits and 
Risks,'' ``Alcohol and the Cardiovascular System,'' at 117-118 
(``Clearly, younger persons cannot possibly benefit much from 
alcohol consumption, at least in the short term, because their risk 
of ischemic CVD events is so low.'').
    4. DuFour, M.C., ``Risks and Benefits of Alcohol Use Over the 
Life Span,'' ``Alcohol Health & Research World,'' Vol. 20, No. 
3:145-150 at 147, 1996.
    5. See, e.g., Hennekens, C.H., ``Alcohol and risk of coronary 
events,'' Research Monograph No. 31, ``Alcohol and the 
Cardiovascular System'' at 20 (National Institutes of Health, 
National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 
1996) (``while the health risks of excessive drinking are clear, 
there may also be hazards associated with moderate intake that must 
be weighed, on an individual basis, against the apparent protection 
against CHD.'').

How This Document Complies With the Federal Administrative 
Requirements for Rulemaking

A. Executive Order 12866

    We have determined that this proposed rule is not a significant 
regulatory action as defined in E.O. 12866. Therefore, a Regulatory 
Assessment is not required.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency 
to conduct a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements unless the agency certifies 
that the rule will not have a significant economic impact on a 
substantial number of small entities. Small entities include small 
businesses, small not-for-profit enterprises, and small governmental 
jurisdictions. We have determined that this proposed rule will not have 
a significant economic impact on a substantial number of small 
entities. The proposed regulations merely clarify ATF's existing policy 
concerning the use of health claims in the labeling and advertising of 
alcohol beverages and impose no burdens on the industry. Accordingly, a 
regulatory flexibility analysis is not required.

C. Paperwork Reduction Act

    The provisions of the Paperwork Reduction Act of 1995, Public Law 
104-13, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR 
part 1320, do not apply to this notice of proposed rulemaking because 
no requirement to collect information is imposed.

Public Participation

    We are requesting comments on the proposed regulations from all 
interested persons. In particular, we are asking for public comment on 
our existing policy relating to health claims and other health-related 
statements on alcohol beverage labels and in advertisements (see 
section II). We also ask whether health-related statements on alcohol 
beverage labels and advertising directing consumers to balanced sources 
of information are misleading and whether ATF should continue to 
approve such statements. We are also asking whether the negative health 
consequences of alcohol consumption or abuse disqualify, as misleading, 
these products entirely from entitlement to any health-related 
statements (see section III). In addition, we are specifically 
requesting comments on the clarity of this proposed rule and how it may 
be made easier to understand.
    Comments received on or before the closing date will be carefully 
considered. Comments received after that date will be given the same 
consideration if it is practical to do so, but assurance of 
consideration cannot be given except as to comments received on or 
before the closing date.
    ATF will not recognize any material in comments as confidential. 
Comments may be disclosed to the public. Any material that the 
commenter considers to be confidential or inappropriate for disclosure 
to the public should not be included in the comment. The name of the 
person submitting a comment is not exempt from disclosure.
    Any interested person who desires an opportunity to comment orally 
at a public hearing should submit his or her request, in writing, to 
the Director within the 120-day comment period. The Director, however, 
reserves the right to determine, in light of all

[[Page 57417]]

circumstances, whether a public hearing is necessary.

Disclosure

    Copies of this notice and the comments received will be available 
for public inspection during normal business hours at: ATF Public 
Reading Room, Room 6480, 650 Massachusetts Avenue, NW, Washington, DC.

Drafting Information

    The author of this document is James P. Ficaretta, Regulations 
Division, Bureau of Alcohol, Tobacco and Firearms.

List of Subjects

27 CFR Part 4

    Advertising, Consumer protection, Customs duties and inspection, 
Imports, Labeling, Packaging and containers, and Wine.

27 CFR Part 5

    Advertising, Consumer protection, Customs duties and inspection, 
Imports, Labeling, Liquors, and Packaging and containers.

27 CFR Part 7

    Advertising, Consumer protection, Customs duties and inspection, 
Imports, and Labeling.

Authority and Issuance

    For the reasons discussed in the preamble, ATF amends 27 CFR parts 
4, 5, and 7 as follows:

PART 4--LABELING AND ADVERTISING OF WINE

    Paragraph 1. The authority citation for 27 CFR part 4 continues to 
read as follows:

    Authority: 27 U.S.C. 205.

    Par. 2. Section 4.39(h) is revised to read as follows:


Sec. 4.39  Prohibited practices.

* * * * *
    (h) Curative and therapeutic claims. Labels may not contain any 
statement, design, representation, pictorial representation, or device, 
whether explicit or implicit, that represents that the use of wine has 
curative or therapeutic effects if such statement is untrue in any 
particular or tends to create a misleading impression. A substantive 
claim regarding health benefits associated with the use of wine is 
misleading unless such claim is properly qualified, balanced, 
sufficiently detailed and specific, and outlines the categories of 
individuals for whom any positive health effects would be outweighed by 
numerous negative health effects.
* * * * *
    Par. 3. Section 4.64(i) is revised to read as follows:


Sec. 4.64  Prohibited practices.

* * * * *
    (i) Curative and therapeutic claims. Advertisements may not contain 
any statement, design, representation, pictorial representation, or 
device, whether explicit or implicit, that represents that the use of 
wine has curative or therapeutic effects if such statement is untrue in 
any particular or tends to create a misleading impression. A 
substantive claim regarding health benefits associated with the use of 
wine is misleading unless such claim is properly qualified, balanced, 
sufficiently detailed and specific, and outlines the categories of 
individuals for whom any positive health effects would be outweighed by 
numerous negative health effects.
* * * * *

PART 5--LABELING AND ADVERTISING OF DISTILLED SPIRITS

    Par. 4. The authority citation for 27 CFR part 5 continues to read 
as follows:

    Authority: 26 U.S.C. 5301, 7805; 27 U.S.C. 205.

Par. 5. Section 5.42(b)(8) is revised to read as follows:


Sec. 5.42  Prohibited practices.

* * * * *
    (b) * * *
    (8) Curative and therapeutic claims. Labels may not contain any 
statement, design, representation, pictorial representation, or device, 
whether explicit or implicit, that represents that the use of distilled 
spirits has curative or therapeutic effects if such statement is untrue 
in any particular or tends to create a misleading impression. A 
substantive claim regarding health benefits associated with the use of 
distilled spirits is misleading unless such claim is properly 
qualified, balanced, sufficiently detailed and specific, and outlines 
the categories of individuals for whom any positive health effects 
would be outweighed by numerous negative health effects.
    Par. 6. Section 5.65(d) is revised to read as follows:


Sec. 5.65  Prohibited practices.

* * * * *
    (d) Curative and therapeutic claims. Advertisements may not contain 
any statement, design, representation, pictorial representation, or 
device, whether explicit or implicit, that represents that the use of 
distilled spirits has curative or therapeutic effects if such statement 
is untrue in any particular, or tends to create a misleading 
impression. A substantive claim regarding health benefits associated 
with the use of distilled spirits is misleading unless such claim is 
properly qualified, balanced, sufficiently detailed and specific, and 
outlines the categories of individuals for whom any positive health 
effects would be outweighed by numerous negative health effects.
* * * * *

PART 7--LABELING AND ADVERTISING OF MALT BEVERAGES

    Par. 7. The authority citation for 27 CFR part 7 continues to read 
as follows:

    Authority: 27 U.S.C. 205.

    Par. 8. Section 7.29(e) is revised to read as follows:


Sec. 7.29  Prohibited practices.

* * * * *
    (e) Curative and therapeutic claims. Labels may not contain any 
statement, design, representation, pictorial representation, or device, 
whether explicit or implicit, that represents that the use of malt 
beverages has curative or therapeutic effects if such statement is 
untrue in any particular or tends to create a misleading impression. A 
substantive claim regarding the health benefits associated with the use 
of malt beverages is misleading unless such claim is properly 
qualified, balanced, sufficiently detailed and specific, and outlines 
the categories of individuals for whom any positive health effects 
would be outweighed by numerous negative health effects.
* * * * *
    Par. 9. Section 7.54(e) is revised to read as follows:


Sec. 7.54  Prohibited practices.

* * * * *
    (e) Curative and therapeutic claims. Advertisements may not contain 
any statement, design, representation, pictorial representation, or 
device, whether explicit or implicit, that represents that the use of 
malt beverages has curative or therapeutic effects if such statement is 
untrue in any particular or tends to create a misleading impression. A 
substantive claim regarding health benefits associated with the use of 
malt beverages is misleading unless such claim is properly qualified, 
balanced, sufficiently detailed and specific, and outlines the 
categories of individuals for whom any positive health effects would

[[Page 57418]]

be outweighed by numerous negative health effects.
* * * * *
    Signed: October 19, 1999.
John W. Magaw,
Director.

    Approved: October 20, 1999.
John P. Simpson,
Deputy Assistant Secretary (Regulatory, Tariff and Trade Enforcement).
[FR Doc. 99-27774 Filed 10-20-99; 3:28 pm]
BILLING CODE 4810-31-P