[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
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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