[Federal Register: March 3, 2003 (Volume 68, Number 41)]
[Rules and Regulations]
[Page 10075-10106]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr03-20]
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Part II
Department of Treasury
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Alcohol and Tobacco and Trade Bureau
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27 CFR Parts 4, 5, and 7
Health Claims and Other Health-Related Statements in the Labeling and
Advertising of Alcohol Beverages (99R-199P); Final Rule
[[Page 10076]]
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DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade Bureau
27 CFR Parts 4, 5, and 7
[TTB T.D.-1; Ref: ATF Notice Nos. 884, 892, and 896]
RIN: 1512-AB97
Health Claims and Other Health-Related Statements in the Labeling
and Advertising of Alcohol Beverages (99R-199P)
AGENCY: Alcohol and Tobacco Tax and Trade Bureau (TTB), Treasury.
ACTION: Final rule, Treasury decision.
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SUMMARY: TTB is amending the regulations to prohibit the appearance on
labels or in advertisements of any health-related statement, including
a specific health claim, that is untrue in any particular or tends to
create a misleading impression. A specific health claim on a label or
in an advertisement is considered misleading unless the claim is
truthful and adequately substantiated by scientific evidence; properly
detailed and qualified with respect to the categories of individuals to
whom the claim applies; adequately discloses the health risks
associated with both moderate and heavier levels of alcohol
consumption; and outlines the categories of individuals for whom any
levels of alcohol consumption may cause health risks. In addition, TTB
will consult with the Food and Drug Administration (FDA), as needed, on
the use of specific health claims on labels. If FDA determines that a
specific health claim is a drug claim that is not in compliance with
the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will
not approve the use of such statement on a label.
Health-related statements that are not specific health claims or
health-related directional statements will be evaluated on a case-by-
case basis to determine if they tend to mislead consumers. The final
rule provides that health-related directional statements (statements
that direct or refer consumers to a third party or other source for
information regarding the effects on health of alcohol consumption)
will be presumed misleading unless those statements include a brief
disclaimer advising consumers that the statement should not encourage
consumption of alcohol for health reasons, or some other appropriate
disclaimer to avoid misleading consumers. TTB believes that the final
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.
DATES: This rule is effective June 2, 2003.
FOR FURTHER INFORMATION CONTACT: William H. Foster, Regulations and
Procedures Division, Alcohol and Tobacco Tax and Trade Bureau, 650
Massachusetts Avenue, NW., Washington, DC 20226 (202-927-8210).
SUPPLEMENTARY INFORMATION: Please note: References to ``ATF'' are to
the Bureau of Alcohol, Tobacco and Firearms as it existed before
January 24, 2003. The new Alcohol and Tobacco Tax and Trade Bureau
(TTB) has taken over the former ATF's responsibilities for alcohol
beverage labeling regulations.
Table of Contents
I. Background
II. Health Consequences of Alcohol Consumption
III. Industry Circular 93-8
IV. Role of Other Federal Agencies With Respect to Specific Health
Claims and Other Health-Related Statements
V. Fourth Edition of the Dietary Guidelines for Americans (1995)
VI. Competitive Enterprise Institute Petition
VII. Other Health-Related Statements on Alcohol Beverage Labels
VIII. Notice of Proposed Rulemaking
IX. Notice of Hearings
X. Recent Developments
XI. Analysis of Comments Received in Response to Notice No. 884
XII. Is There a Need To Engage in Rulemaking on This Issue?
XIII. Does the ABLA Preclude the Use of Specific Health Claims or
Other Health-Related Statements on the Labels of Alcohol Beverages?
XIV. What Are the Effects on Health of Alcohol Consumption?
XV. Are Health Claims and Health-Related Statements in the Labeling
and Advertising of Alcohol Beverages Inherently Misleading?
XVI. Are Health-Related Directional Statements Misleading?
XVII. Should the Same Standards Apply to Wines, Distilled Spirits,
and Malt Beverages?
XVIII. Should TTB Adopt the Procedures Set Forth in FDA's
Regulations?
XIX. Is the Final Rule Consistent With the First Amendment?
XX. Final Rule
XXI. Applications for and Certificates of Label Approval
XXII. Notes Appearing in Text of Supplementary Information
XXIII. How This Document Complies With the Federal Administrative
Requirements for Rulemaking
Disclosure
Drafting Information
List of Subjects
Authority and Issuance
I. Background
The Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e)
and (f), authorizes TTB to issue regulations on the packaging, labeling
and advertising of alcohol beverages in order to prohibit deception of
the consumer, and to prohibit, irrespective of falsity, statements
relating to analyses, guarantees, and scientific or irrelevant matters
that are likely to mislead the consumer. The FAA Act generally requires
bottlers and importers of alcohol beverages to obtain certificates of
label approval prior to the bottling or importation of alcohol
beverages for sale in interstate commerce. Pre-approval of advertising
is not required by the FAA Act.
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. These current
regulations prohibit the appearance on labels or in advertisements of
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 the representation is
untrue in any particular or tends to create a misleading impression.
This standard originated more than 60 years ago with the initial
labeling and advertising regulations issued under the FAA Act.
TTB and its predecessor agencies have historically taken a very
strict view of the regulatory prohibition on false or misleading
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, we and our predecessors have always taken the position
that statements attributing positive effects on health to the
consumption of alcohol beverages are misleading unless such statements
are appropriately qualified and properly balanced. TTB views statements
that make substantive claims regarding health benefits associated with
alcohol beverage consumption (e.g., ``moderate alcohol consumption is
good for your health'') as making curative or therapeutic claims.
Claims that set forth only a partial picture or representation might be
as likely to mislead the consumer as those that are actually
[[Page 10077]]
false. A claim that is supported by scientific evidence might still
mislead the consumer without appropriate qualification and detail. Any
such claim is considered misleading unless it is properly qualified and
balanced, sufficiently detailed and specific, and outlines the
categories of individuals for whom any positive effects on health would
be outweighed by numerous negative effects on health.
II. Health Consequences of Alcohol Consumption
The risks associated with alcohol consumption are well documented.
In Notice No. 884, ATF summarized these risks as set forth in an
article by Charles H. Hennekens, M.D. as follows: \1\
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. residents suffer from alcohol
abuse and dependence, and 76 million are affected by its presence in
a family member. (Citations omitted).
It is true that heavier levels of alcohol consumption cause many of
these health risks. 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, it was ATF's
longstanding, and is now our, position that 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.
Prior to engaging in this rulemaking, ATF recognized that there
were several scientific studies establishing a link between moderate
alcohol consumption and a reduced risk of coronary artery disease
(``CAD'').\2\ However, it was ATF's conclusion that there was not
significant scientific evidence to support an unqualified conclusion
that moderate alcohol consumption has net health benefits for all or
even most individual consumers. Some studies have suggested that only
older drinkers will accrue any net 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 outcome 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 levels. * * *. 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. (Citations
omitted).
Overall, the available scientific literature establishes that there
may be serious health risks associated with heavy as well as moderate
alcohol consumption, depending on the individual.\5\
III. Industry Circular 93-8
On August 2, 1993, ATF published Industry Circular 93-8. The
circular generally restated ATF's longstanding position regarding
misleading curative and therapeutic claims. ATF explained that claims
that set forth only a partial picture, representation, or truth might
be as likely to mislead the consumer as those that are actually false.
Thus, a statement that attributed health benefits to the moderate
consumption of alcohol beverages, even if backed up by medical
evidence, might have an overall misleading effect if such statement was
not properly qualified, did not give all sides of the issue, and did
not outline the categories of individuals for whom any such positive
effect would be outweighed by numerous negative effects on health.
ATF also explained that its 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 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 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 effectuate this goal,
Congress prescribed specific language that must appear on the labels of
alcohol beverage containers. To the extent that the overall message of
any health claim is inconsistent with the message of the Government
warning statement, then it may result in label information that is
confusing and could mislead the consumer, and would thus be prohibited
under the FAA Act.
In Industry Circular 93-8, ATF further noted that other Federal
agencies, such as the Food and Drug Administration and the Federal
Trade Commission, might have jurisdiction over certain aspects of
advertising and labeling issues involving health claims. We will
address this issue further in section IV (``Role of Other Federal
Agencies with Respect to Specific Health Claims and other Health-
Related Statements'').
ATF also stated that the distribution of advertising materials that
included the full text of the April 1992 edition of ``Alcohol Alert,''
a publication of 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. The industry circular
[[Page 10078]]
stated that if the advertising materials also contained editorializing,
advertising slogans, or exhortations to consume the product, ATF would
evaluate the additional text to determine whether or not the
advertisement presented a balanced picture of the risks associated with
alcohol consumption. In addition, ATF stated that the use of buttons,
shelf talkers (additional product information placed on the retail
shelf), table tents, and similar items that excerpt any portion of the
NIAAA publication, contain health slogans or other inferential
statements drawn from this publication, or are based on any other
publication or article citing the health benefits of alcohol
consumption, would be closely scrutinized to determine if they
presented a balanced picture of the risks associated with alcohol
consumption.
ATF 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 on
health would be outweighed by numerous negative effects on health.
Finally, ATF stated that it intended to initiate rulemaking on this
issue; however, pending rulemaking, ATF would continue to evaluate
claims in labeling and advertising on a case-by-case basis.
IV. Role of Other Federal Agencies With Respect to Specific Health
Claims and Other Health-Related Statements
While TTB now 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 generally falls
within FDA's jurisdiction. ATF always utilized, as TTB does now, 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.
By letter dated April 9, 1993, FDA advised ATF 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 (FFDC Act), 21 U.S.C. 321(g)(1)(B).
FDA evaluates health claims on food labels pursuant to its authority
under the FFDC Act, as amended by the Nutrition Labeling and Education
Act (NLEA), Pub. L. 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 FDA. 21 U.S.C. 343(r)(1)(B). FDA's regulations provide that FDA will
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).
FTC's general jurisdiction over advertising extends to alcohol
beverages. In a policy statement published in the Federal Register on
June 1, 1994 (59 FR 28394), 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.'' 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 risk for another
disease or health-related condition, and the risk-increasing nutrient
was closely related to the subject health claim.
V. Fourth Edition of the Dietary Guidelines for Americans (1995)
The Fourth Edition (1995) of the ``Dietary Guidelines for
Americans'' was published by the U.S. Department of Agriculture (USDA)
and the U.S. Department of Health and Human Services (HHS) in 1996.
This edition of the Guidelines contained a detailed discussion of the
health consequences of alcohol consumption.
The 1995 Guidelines acknowledged that ``[c]urrent evidence suggests
that moderate drinking is associated with a lower risk for coronary
heart disease in some individuals.'' The Guidelines then went on to
discuss the ``serious health problems'' caused by higher levels of
alcohol consumption, including increased risk for high blood pressure,
stroke, and heart disease.
The 1995 Guidelines recommended that if adults chose to drink
alcohol beverages, they should consume them only in moderation. The
term ``moderation'' was defined as no more than one drink per day for
women and no more than two drinks per day for men. However, the 1995
Guidelines stressed that 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 1995
Guidelines suggested that individuals of any age who could not restrict
their drinking to moderate levels should not drink at all.
VI. Competitive Enterprise Institute Petition
On May 9, 1995, the Competitive Enterprise Institute (CEI)
submitted a petition asking ATF to issue a rule allowing alcohol
beverage labels and advertisements to carry statements regarding the
purported benefits of moderate alcohol consumption. More specifically,
CEI proposed that ATF issue a rule specifically allowing the following
statement to appear on labels and in advertisements: ``There is
significant evidence that moderate consumption of alcoholic beverages
may reduce the risk of heart disease.'' By letter dated November 10,
1995, CEI submitted a survey purporting to show that less than 42
percent of the general public was ``aware of the medical benefits of
moderate consumption.''
By letter dated January 13, 1997, ATF denied CEI's rulemaking
petition. ATF determined that CEI's proposed claim was not
appropriately qualified, in that it did not define the categories of
individuals for whom there would be no appreciable benefits (such as
younger individuals already at low risk of heart disease), or
individuals for whom there would be significant risks associated with
moderate alcohol consumption (such as recovering alcoholics and persons
otherwise at risk for alcohol abuse, or people with certain medical
conditions). The claim was not balanced, in that it did not explain the
significant risks associated with higher levels of alcohol consumption,
as well as the potential risks of moderate alcohol consumption for
certain individuals. ATF found that the claim, taken in isolation,
would tend to mislead the consumer about the significant health
consequences of alcohol consumption.
Before ATF had issued its denial of CEI's petition, CEI had filed
suit (October 29, 1996) in the United States District Court for the
District of Columbia, challenging ATF's delay in
[[Page 10079]]
acting on its petition. In 1997, CEI amended its complaint to challenge
ATF's denial of the rulemaking petition. CEI also alleged that ATF had
a ``de facto'' ban on the use of health claims, which violated the
First Amendment and the FAA Act. In 1998, the district court granted
the Government's motion for summary judgment on CEI's challenge to the
denial of its rulemaking petition. Both parties filed motions for
summary judgment on the remaining issues.
VII. Other Health-Related Statements on Alcohol Beverage Labels
On February 4, 1999, ATF approved two applications for certificates
of label approval bearing directional health-related statements
directing consumers to the Dietary Guidelines or their family doctor
for information about the ``health effects of wine consumption.'' ATF
approved those labels based on its determination that the statements
were not substantive health claims, but instead were neutral statements
directing consumers to third parties for additional information
regarding the effects on health of alcohol consumption. The first
approved labeling statement read as follows:
The proud people who made this wine encourage you to consult
your family doctor about the health effects of wine consumption.
The second labeling statement read as follows:
To learn the health effects of wine consumption, send for the
Federal Government's Dietary Guidelines for Americans, Center for
Nutrition Policy and Promotion, USDA, 1120 20th Street, NW.,
Washington, DC 20036 or visit its web site: http://www.usda.gov/fcs/
cnpp.htm.
Prior to being approved, the two applications received a great deal
of public attention. In July of 1997, both HHS and FTC urged ATF not to
approve the labels until a consumer survey was conducted. In that same
month, Senators Robert Byrd and Strom Thurmond wrote to the Secretary
of the Treasury, also raising several concerns about the proposed
labeling statements. ATF also received several letters from public
health organizations concerned that the labels would encourage
consumers to consume alcohol beverages for health reasons. In view of
these concerns, ATF decided to defer final action on the labels pending
the completion of a consumer survey by the Center for Substance Abuse
Prevention (CSAP), a component of HHS.
In January of 1998, CSAP transmitted to ATF the main findings from
its consumer survey. The survey found that most subjects reported that
they do not read wine labels, and that neither of the two labeling
statements would likely induce wine drinkers to alter their drinking
pattern, quantitatively or otherwise. However, several members of the
focus groups reported that information about the positive effects on
health of wine consumption from the media had led them to increase
their wine intake.
While the CSAP survey did not establish that the labeling
statements would influence the drinking patterns of wine drinkers, it
did indicate that heavy drinkers may justify or increase their
consumption levels based on their independent understanding of
information regarding the alleged health benefits of moderate
consumption. Furthermore, the survey established that consumers would
be no more likely to seek additional health information after reading
the proposed labeling statements.
Based on the evidence before it, including the consumer survey
conducted by CSAP, ATF concluded that there was insufficient evidence
in the record to establish that the directional statements tended to
mislead consumers about the effects on health of alcohol consumption.
Accordingly, the labels were approved.
The approval of these labels generated considerable interest from
Federal health officials, members of Congress, and public advocacy
groups, who expressed concern about consumer perception of the label
statements. Of particular note, former Surgeon General David Satcher
expressed concern that people might draw an incorrect message from
these labels.
Moreover, ATF became aware of a number of press accounts
interpreting the directional statements as actual health claims about
the benefits of alcohol consumption. For example, on February 5, 1999,
the ``Wall Street Journal'' wrote that the expected decision to approve
the labels would allow ``wine producers to put labels on bottles that
point to the potential health benefits of their product.'' On February
5, 1999, the Associated Press reported the decision as follows:
``Scientific studies have suggested it, and now winemakers finally may
get a chance to tout it through their labeling: A glass or two of the
grape each day could be good for you.'' On February 6, 1999, the ``Los
Angeles Times'' reported that ``[t]he federal government approved
changes Friday that will allow winemakers for the first time to tout on
labels the connection between drinking wine and better health.'' That
same date, the ``Washington Post'' reported that ATF had ``decided that
winemakers may add another label to the bottle to encourage consumers
to learn more about the possible benefits of drinking wine.'' In an
article dated February 9, 1999, the ``San Francisco Examiner'' stated
that ATF's decision ``would allow winemakers to carry bottle labels
suggesting consumers check with their doctors or the government's
nutritional guidelines on the possible health benefits of wine.''
VIII. Notice of Proposed Rulemaking
On October 25, 1999, ATF invited comments on its current policy on
health claims and health-related statements by publishing the policy as
a proposed regulation in the Federal Register (Notice No. 884; 64 FR
57413). As proposed, labels or advertisements could 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 would be misleading unless such claim was properly
qualified and balanced, sufficiently detailed and specific, and
outlined the categories of individuals for whom any positive effects on
health would be outweighed by numerous negative effects on health.
ATF also sought comments on whether even balanced and qualified
health claim statements should be prohibited because the negative
consequences of alcohol consumption are so serious as to make any
health-related statement on labels or in advertisements inherently
misleading. In addition, ATF sought comments on whether health-related
directional statements such as those approved in February 1999 tend to
mislead consumers about the health consequences of alcohol consumption.
The comment period for Notice No. 884, initially scheduled to close
on February 22, 2000, was extended until June 30, 2000, pursuant to
Notice No. 896. (See following section, ``Notice of Hearings.'')
IX. Notice of Hearings
On December 9, 1999, ATF announced in a press release that after
the close of the comment period, it would hold public hearings on the
issue of health claims in the labeling and advertising of alcohol
beverages. ATF stated that the hearings would provide it with a
comprehensive record on
[[Page 10080]]
which to base final regulations on health claims.
Because it was seeking public comments on this very issue, ATF
announced that it would suspend action on any new applications for
label approval bearing similar health-related directional statements
pending the completion of the rulemaking proceeding. ATF noted that due
to the adverse consequences of alcohol consumption, it was concerned
about any risk of misperception resulting from the two approved
statements.
On February 28, 2000, ATF published a notice in the Federal
Register announcing the dates and locations of five hearings that it
planned to hold concerning the proposed regulations (Notice No. 892; 65
FR 10434). ATF subsequently canceled the hearings that were scheduled
for Atlanta, Chicago, and Dallas, due to the low number of requests to
present oral comments in those locations (Notice No. 896; 65 FR 24158).
In addition, the hearings scheduled for Washington, DC and San
Francisco, California, were limited to two days each. The hearing in
Washington, DC was held on April 25-26, 2000, and the hearing in San
Francisco was held on May 23-24, 2000. ATF also extended the close of
the comment period regarding Notice No. 884 from February 22, 2000, to
June 30, 2000. Written comments addressing testimony presented at the
hearings could also be submitted up until June 30, 2000.
X. Recent Developments
A. 1999 Alcohol Alert
In 1999, NIAAA published an ``Alcohol Alert'' on ``Alcohol and
Coronary Heart Disease'' (No. 45-1999). In this publication, NIAAA
reaffirmed that ``[r]esearch has revealed an association between
moderate alcohol consumption and lower risk for CHD.'' (Footnote
omitted). However, NIAAA cautioned that ``[a]n association between
moderate drinking and lower risk for CHD does not necessarily mean that
alcohol itself is the cause of the lower risk. For example, a review of
population studies indicates that the higher mortality risk among
abstainers may be attributable to shared traits other than the
participants' nonuse of alcohol.'' (Footnote omitted). NIAAA noted that
``[t]he role of exercise in the alcohol-CHD association requires
additional study.''
NIAAA noted that ``[t]he apparent benefits of moderate drinking on
CHD mortality are offset at higher drinking levels by increasing risk
of death from other types of heart disease; cancer; liver cirrhosis;
and trauma, including trauma from traffic crashes. Moderate drinking is
not risk free. The trade-offs between risks and benefits can be
exemplified by the fact that alcohol's anticlotting ability,
potentially protective against heart attack, may increase the risk of
hemorrhagic stroke, or bleeding within the brain.'' (Footnotes
omitted).
In a commentary that appeared with the Alert, NIAAA Director Enoch
Gordis, M.D., offered the following advice with respect to the health
implications of alcohol consumption:
(1) Individuals who are not currently drinking should not be
encouraged to drink solely for health reasons, because the basis for
health improvements has not yet been established as deriving from
alcohol itself;
(2) Individuals who choose to drink and are not otherwise at
risk for alcohol-related problems should not exceed the one-to two-
drink-per-day limit recommended by the U.S. Dietary Guidelines; and
(3) Individuals who currently are drinking beyond the U.S.
Dietary Guidelines' recommended limits should be advised to lower
their daily alcohol intake to these limits.
B. Dietary Guidelines--Fifth Edition (2000)
In the summer of 2000, USDA and HHS published the ``Dietary
Guidelines for Americans, 2000.'' The 2000 Dietary Guidelines contain
more specific guidance about alcohol consumption, and summarize the
current medical evidence regarding the risks associated with alcohol
consumption as follows:
Alcoholic beverages supply calories but few nutrients. Alcoholic
beverages are harmful when consumed in excess, and some people
should not drink at all. Excess alcohol alters judgment and can lead
to dependency and a great many other serious health problems. Taking
more than one drink per day for women or two drinks per day for men
* * * can raise the risk for motor vehicle crashes, other injuries,
high blood pressure, stroke, violence, suicide, and certain types of
cancer. Even one drink per day can slightly raise the risk of breast
cancer. Alcohol consumption during pregnancy increases risk of birth
defects. Too much alcohol may cause social and psychological
problems, cirrhosis of the liver, inflammation of the pancreas, and
damage to the brain and heart. Heavy drinkers are also at risk of
malnutrition because alcohol contains calories that may substitute
for those in nutritious foods. If adults choose to drink alcoholic
beverages, they should consume them only in moderation * * * and
with meals to slow alcohol absorption.
The 2000 Dietary Guidelines also contain a discussion of the
possible health benefits of alcohol consumption; however, the following
excerpt from this section emphasizes that these benefits accrue
primarily to older drinkers, and that there are other ways of reducing
the risk of heart disease:
Drinking in moderation may lower risk for coronary heart
disease, mainly among men over age 45 and women over age 55.
However, there are other factors that reduce the risk of heart
disease, including a healthy diet, physical activity, avoidance of
smoking, and maintenance of a healthy weight. Moderate consumption
provides little, if any, health benefit for younger people. Risk of
alcohol abuse increases when drinking starts at an early age. Some
studies suggest that older people may become more sensitive to the
effects of alcohol as they age.
The 2000 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. 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; individuals of
any age who cannot restrict their drinking to moderate levels; women
who may become pregnant or who are pregnant; individuals who plan to
drive, operate machinery, or take part in other activities that require
attention, skill, or coordination; and individuals taking prescription
or over-the-counter medications that can interact with alcohol.
C. Recent Developments in the CEI Litigation
On June 18, 2001, the district court granted the Government's
motion for summary judgment on the remaining issues in the CEI
litigation. The court ruled that the case was not ready for judicial
review given the fact that ATF was in the middle of a rulemaking
proceeding on the very issues raised by CEI in the litigation. The
plaintiffs appealed this decision to the Court of Appeals. On May 10,
2002, the appellate court upheld the district court's ruling that the
case was not ripe (ready) for judicial review because ATF was nearing
completion of a rulemaking proceeding on the use of health claims.
Thereafter, the plaintiffs filed a petition for rehearing with the
Court of Appeals that was denied.
XI. Analysis of Comments Received in Response to Notice No. 884
In response to Notice No. 884, ATF received 535 comments. Comments
were submitted by several United States Senators, two Federal agencies,
an agency of a foreign government, consumers and consumer
organizations,
[[Page 10081]]
medical professionals (including physicians, nurses, and local health
departments), public health organizations, industry members, and
others.
As previously noted, in Notice No. 884 ATF sought comments on
whether the serious health risks associated with alcohol consumption
meant that any health claim, even a balanced and qualified one, was
inherently misleading to consumers. In response, approximately 45
commenters supported the use of substantive health claims or health-
related statements in the labeling and advertising of alcohol
beverages. On the other side, approximately 120 commenters opposed the
use of either substantive health claims or health-related directional
statements in the labeling or advertising of alcohol beverages. Many of
these commenters suggested that health statements were inherently
misleading when used to market alcohol beverages.
ATF specifically sought comments on whether health-related
directional labeling statements such as the ones approved in February
1999 tended to mislead consumers about the health consequences of
alcohol consumption. The vast majority of the commenters focused
exclusively on this issue. Approximately 355 comments supported the use
of health-related directional statements on alcohol beverage labels.
The major issues raised by the commenters, as well as the individuals
who testified at the public hearings, are summarized below.
XII. Is There a Need To Engage in Rulemaking on This Issue?
A. Issue
Four comments either opposed ATF's decision to engage in rulemaking
on this issue or suggested that the notice of proposed rulemaking be
withdrawn. These were comments submitted by the Beer Institute, a trade
association for domestic and international brewers; the National
Association of Beverage Importers (NABI), a trade association
representing importers of beer, wine, and distilled spirits; the
Distilled Spirits Council of the United States (DISCUS), a national
trade association representing producers and marketers of distilled
spirits and importers of wine; and a comment submitted jointly by CEI
and Consumer Alert (CA).
DISCUS, the Beer Institute, and NABI all questioned the necessity
for engaging in rulemaking on the issue of health claims and health-
related statements in the labeling and advertising of alcohol
beverages. (Comments 530, 396, and 522). These comments suggested that
the authorization of any directional statement on a label would be in
violation of the ABLA. TTB does not agree with this legal analysis.
This issue will be discussed further in section XIII.
DISCUS and Beer Institute also objected to the proposed advertising
regulations. DISCUS suggested that ATF's proposal was ``insurmountably
vague and ambiguous. It only would serve to interfere with the rights
of advertisers to engage in truthful, non-misleading speech about their
products that are consumed responsibly by over a hundred million
Americans.'' DISCUS suggested that ``[a]n advertiser could run afoul of
the provisions of BATF's proposed rule without making any type of
curative or therapeutic claim,'' giving as an example an advertisement
depicting attractive individuals relaxing in an enjoyable setting. The
Beer Institute similarly suggested that the requirements for labeling
and advertising should be separate, and that the proposed regulation
complicated the existing advertising standard. The Beer Institute
suggested that the current standard is readily understood and
straightforward, and that instead of issuing new regulations, ATF
should adopt a more formal review process of health statements on a
case-by-case basis.
These commenters also suggested that large portions of the alcohol
beverage industry had no interest in using health claims in the
labeling or advertising of their products. For example, the Beer
Institute comment suggested that there was no need to amend the malt
beverage regulations, since to its knowledge, none of its constituents
had ever used such claims in the past, and none had any intention to do
so in the future. NABI raised similar concerns, and stated that it did
not support the proposed amendment to the regulations ``because any
such support might imply the industry intends to make health-related
statements on its labels and in its advertising.'' The comment from
DISCUS stressed that ``America's distillers do not recommend that
consumers drink beverage alcohol for health reasons.'' (Comment 530).
CEI, a pro-market public interest group dedicated to advancing the
principles of free markets and limited government, and CA, a free-
market consumer advocacy group, suggested that the proposed rule should
be withdrawn because the issuance of a regulation based on the proposal
would restrict commercial speech in a way that violates the First
Amendment. (Comment 326). These issues will be discussed further in
section XIX.
B. Decision
After carefully considering the record, TTB has determined that it
is important to issue a final rule on specific health claims and other
health-related statements in the labeling and advertising of alcohol
beverages. The rulemaking record confirms that alcohol abuse is an
important public health issue. The use of health claims and health-
related statements in the labeling and advertising of alcohol beverages
requires a balance between a producer's First Amendment right to label
and advertise its products in a truthful and non-misleading fashion and
the public's right to be informed of the significant health risks
associated with alcohol consumption. Specific regulations on the use of
health claims and other health-related statements in the labeling and
advertising of alcohol beverages will ensure that both the industry and
the public are aware of the restrictions on the use of labeling and
advertising statements that might tend to mislead the consumer about
the serious health risks associated with alcohol consumption.
TTB recognizes that based on the administrative record, it does not
appear that distillers and brewers are interested in using health
claims or health-related statements in the labeling or advertising of
alcohol beverages. However, as noted later in this preamble, both the
Wine Institute and the American Vintners Association (AVA), two
industry associations representing hundreds of wineries, supported
ATF's proposed rule regarding substantive health claims. At least one
individual testifying at the hearing, Mr. John Hinman, indicated that
there were wineries interested in using a 664-word substantive health
claim in advertising materials. The Wine Institute and AVA, as well as
many individual wineries, commented in favor of allowing directional
statements in the labeling of alcohol beverages. Thus, the record
reflects that there may be some wineries interested in using
substantive health claims in the advertising of alcohol beverages, and
that many wineries are interested in using directional statements on
labels. For this reason, TTB believes it is important to issue
regulations that set forth the standards that must be met in the event
that a specific health claim or other health-related statement is used
in the labeling or advertising of alcohol beverages. As set forth later
in section XVII, the same standards should apply to wines, distilled
spirits, and malt beverages, even if there is no evidence that any
members of the malt beverage or distilled spirits industries are
[[Page 10082]]
interested in using health claims or health-related statements. The
rule does not require anyone to use such statements; it merely sets
forth the standards that would apply in the event that an industry
member wishes to use a specific health claim or a health-related
statement on a label or in an advertisement.
TTB does not agree that the proposed regulations would inject
uncertainty with respect to the use of advertisements that do not
involve health claims or health-related statements, such as the example
provided by DISCUS of an advertisement that shows people relaxing in an
attractive setting. There is nothing in the proposed rule that would
extend the definition of a health claim or curative or therapeutic
claim to cover such advertisements. However, we agree that the lack of
any definition of a ``curative or therapeutic claim'' or ``health
claim'' in the proposed rule might give rise to some uncertainty as to
what types of advertising claims would be covered by the regulation.
Accordingly, the final rule includes definitions of the terms ``health-
related statement'' (which includes statements of a curative or
therapeutic nature), ``specific health claims,'' and ``health-related
directional statements.'' We believe that these definitions should
resolve any concerns by the commenters that the labeling or advertising
regulations are intended to broaden ATF's traditional interpretation of
a curative or therapeutic claim.
XIII. Does the ABLA Preclude the Use of Specific Health Claims or Other
Health-Related Statements on the Labels of Alcohol Beverages?
A. Issue
Five commenters, including Senator Thurmond (Comment 526), DISCUS
(Comment 530), the Beer Institute (Comment 396), NABI (Comment 522),
and Remy Amerique, Inc. (Comment 531), suggested that the use of any
health claims or other health-related statements on alcohol beverage
labels was foreclosed by the provisions of the ABLA. They argued that
it was Congress' intent to foreclose the use of any other health-
related statements on alcohol beverage labels.
B. Decision
TTB does not agree with those commenters who suggested that the
ABLA specifically precludes the voluntary use by industry members of
any health-related statements on alcohol beverage labels other than the
required warning statement. The ABLA was enacted in 1988. Pursuant to
27 U.S.C. 215, alcohol beverage containers distributed or sold in the
United States must bear a Government warning statement, which warns
that alcohol consumption during pregnancy may cause birth defects; that
alcohol consumption impairs one's ability to drive a car or to operate
machinery; and that consumption of alcohol beverages ``may cause health
problems.''
Some commenters argued that the ABLA provided ATF with authority to
deny any statement on an alcohol beverage label that discusses the
relationship between alcohol consumption and health. The ABLA provides
that ``[n]o statement relating to alcoholic beverages and health, other
than the statement required by section 204 [27 U.S.C. 215] of this
title, shall be required under State law to be placed on any container
of an alcoholic beverage, or on any box, carton, or other package,
irrespective of the material from which made, that contains such a
container.'' This section of the law preempts State governments from
each requiring their own version of a health warning statement on
alcohol beverage containers. However, it in no way precludes producers
from voluntarily placing either additional warning statements or health
claims on alcohol beverage labels. See also 27 U.S.C. 213 (setting
forth Congress' policy to ensure that the public is adequately reminded
about any health hazards that may be associated with alcohol
consumption or abuse, and not impeded by ``diverse, nonuniform, and
confusing requirements for warnings or other information on alcoholic
beverage containers with respect to any relationship between the
consumption or abuse of alcoholic beverages and health'').
Some commenters argued that 27 U.S.C. 217 provides the exclusive
method for allowing additional statements regarding alcohol consumption
and health on the label. Section 217 provides that if the Secretary,
after consulting with the Surgeon General, determines that there should
be a change in the mandatory health warning statement, or if such
statement should be deleted, he shall report such information to the
Congress together with specific recommendations for necessary
amendments to the ABLA. After soliciting public comments on this issue,
ATF determined in 1993 that there was no need to seek changes to the
required health warning statement. However, this provision applies only
to the required health warning statement, not to voluntary statements
that producers seek to place on alcohol beverage labels. Thus, it is
clear that the statute does not specifically preclude the voluntary use
of additional health-related statements on alcohol beverage labels.
XIV. What Are the Effects on Health of Alcohol Consumption?
A. Issue
Most of the commenters who addressed this issue agreed that there
was a link between moderate alcohol consumption and a reduced risk of
heart disease in certain individuals. However, some commenters
concluded that the risks associated with alcohol consumption greatly
outweighed any purported cardiovascular benefits, while other
commenters emphasized the benefits associated with moderate
consumption.
CEI and CA presented a review of the medical evidence summarized by
Michael Gough (Ph.D.), which concluded that most adults would benefit
from moderate alcohol consumption. Dr. Gough stated that ``with the
exception of those well-defined groups of people who should avoid
alcohol, there is clearly convincing evidence for the health benefits
of moderate alcohol consumption.'' Dr. Gough acknowledged that
individuals in their 20s and 30s do not accrue net benefits from
consuming alcohol since they are at low risk for heart disease;
however, he suggests that ``[b]ased on understanding of the biological
basis for the protective effects of alcohol, it is likely that moderate
alcohol consumption in the 20s and 30s is important to the beneficial
effects seen in later years.''
CEI attached numerous medical studies regarding the effects on
health of alcohol consumption. In most important respects, the studies
were consistent with ATF's summary of the medical evidence in Notice
No. 884. Several of the studies reported an association between light
to moderate alcohol consumption and a reduced risk of heart disease.
However, many of these same studies supported the conclusion that the
health benefits of alcohol consumption do not apply to certain groups.
For example, the authors of one study began by noting that ``[m]en
and women who drink alcoholic beverages regularly have, in comparison
with abstainers, higher death rates from injuries, violence, suicide,
poisoning, cirrhosis, certain cancers, and possibly hemorrhagic stroke,
but lower death rates from coronary heart disease and thrombotic
stroke. The net balance of
[[Page 10083]]
risks and benefits is likely to differ in different age groups and
populations.'' \6\ (Footnotes omitted). One of the conclusions of the
study is that ``the balance of adverse and beneficial effects of
drinking on mortality from all causes depends not only on the amount of
alcohol consumed but also on age and background cardiovascular risk.''
\7\
Another article noted that it has not yet been determined how
alcohol reduces the risk of coronary heart disease. The authors stated
that: \8\
Several possible mechanisms for a protective role of alcohol
against coronary disease have been hypothesized, including alcohol-
mediated increases in HDL cholesterol levels. * * * Knowledge of the
basic mechanisms by which alcohol exerts a protective effect against
coronary heart disease is critical to assessing the potential
importance of moderate alcohol consumption to the public health,
particularly if the beneficial effects of alcohol can be achieved
through other interventions. Because heavy consumption of alcohol
has been implicated in accidents, cirrhosis, cancer, and other
adverse outcomes, the difference between drinking small-to-moderate
quantities of alcohol and drinking large amounts may mean the
difference between preventing and causing disease. Any clinical
recommendations based on this epidemiologic evidence should
therefore be cautious. (Footnotes omitted).
Among the more recent studies submitted by CEI and CA was one that
focused on the effects on health of alcohol consumption on women. The
authors noted that before beginning the study, it was unclear
``[w]hether the apparent overall benefit of light-to-moderate alcohol
intake among men'' could be extrapolated to women, noting that ``[a]s
compared with men, women have a lower risk of coronary heart disease,
attain higher blood alcohol concentrations for a given amount of
alcohol consumed, and are more susceptible to alcoholic liver disease.
Moreover, women who consume moderate quantities of alcohol have an
increased risk of breast cancer.'' \9\ (Footnotes omitted). The results
of the study showed that light to moderate female drinkers had a
reduced risk of heart disease, with women who drank one to three drinks
per week having the lowest risk of mortality.\10\ However, the study
concluded that ``the apparent benefit of light-to-moderate alcohol
consumption was mainly confined to women at greater risk for coronary
heart disease, specifically older women and women with one or more
coronary risk factors.'' \11\
The Wine Institute, representing over 500 California winery and
associate members, also submitted summaries of several medical studies
that established a link between moderate alcohol consumption and
reduced risk of cardiovascular disease (Comment 401). In its summary of
these studies, the Wine Institute asserted that moderate drinkers have
a 40-50 percent reduction in coronary artery disease risk compared with
individuals who are abstinent, with a lower overall mortality rate as
well.
As ATF stated in Notice No. 884, the serious health risks
associated with alcohol consumption are well established, and ATF
received many comments from public health organizations that focused on
those adverse consequences. The major points made by these commenters
are summarized below.
Many of the commenters focused on the serious public health risks
associated with alcohol abuse. The National Council on Alcoholism and
Drug Dependence, Inc. (NCADD) commented that ``[w]hile most people who
choose to drink do so without negative health or life consequences,
there are 13.8 million Americans over the age of 18 who have problems
with drinking, including 8.1 million people who are alcoholic. Millions
of others, because of a family history or the addictive potential of
alcohol, are at risk for developing an addiction.'' (Comment 15). NCADD
noted that alcohol contributes to 100,000 deaths annually, making it
the third leading cause of preventable mortality in the United States,
after tobacco and diet/activity patterns. While there are fewer deaths
from alcohol-related causes than from cancer or heart disease, alcohol-
related deaths tend to occur at much younger ages.
Some commenters focused on the cost to society associated with
alcohol abuse. For example, the Center for Science in the Public
Interest (CSPI) commented that ``[a] substantial body of evidence has
shown a positive relationship between the aggregate consumption of
alcohol in society and population rates of alcohol-related diseases,
accidents, criminal violence, and suicide. According to the National
Institute on Alcohol Abuse and Alcoholism (NIAAA), alcohol abuse and
alcoholism cost society more than $166 billion annually and each year
over 110,640 deaths have alcohol-related causes.'' (Comment 400).
(Footnotes omitted).
Many of the commenters set forth the serious risks associated with
higher levels of alcohol consumption. NCADD noted that ``[h]eavy and
chronic drinking can harm virtually every organ and system in the body,
and is the single most important cause of illness and death from liver
disease. It is also associated with cardiovascular diseases such as
cardiomyopathy, hypertension, arrhythmias and stroke.'' The Marin
Institute identified similar health risks associated with alcohol
consumption. (Comment 324).
Many recognized experts on the effects on health of alcohol
consumption testified at the public hearings held by ATF in Washington,
DC and San Francisco, California. Dr. David Satcher, former Assistant
Secretary for Health and Surgeon General, testified about the public
health dangers associated with alcohol consumption as follows:
Although the majority of Americans who consume alcoholic
beverages do so safely, alcohol is one of the nation's leading
causes of preventable injury and premature death. Each year, over
100,000 premature deaths result from alcoholism and alcohol abuse.
Alcohol represents, therefore, the third leading cause of premature
death, right behind tobacco and physical inactivity. Traffic crashes
involving alcohol killed more than 16,000 people in 1997, and one in
four victims of violent crime report that the offender had been
drinking alcohol prior to committing the crime. Fetal alcohol
syndrome continues to be the leading preventable cause of mental
retardation. I think we fail to appreciate that the roots of
alcoholism and alcohol abuse have their origins in adolescence and
that children are especially vulnerable to its dangers. Alcohol is
the nation's number one drug problem among youth, and it is involved
in teen automobile crashes, homicides, and suicides, the three
leading causes of teen death. (April 25, 2000; Washington, DC, pages
72-73).
Other physicians testified regarding the effects on health of
alcohol consumption. Dr. Carlos Camargo, an emergency room physician
and alcohol researcher, testified at the invitation of CSPI. He stated
that ``there is persuasive evidence that moderate alcohol consumption
reduces risk of coronary heart disease in some people. There is also
persuasive evidence that even moderate drinking carries significant
health risks for many people.'' (April 25, 2000; Washington, DC, page
94).
Dr. Michael Criqui, a physician, epidemiologist, and professor,
also expressed concerns regarding the use of any health-related
statement in connection with the labeling of alcohol beverages. Dr.
Criqui stressed that when evaluating the potential health benefits
associated with alcohol consumption, it is important to look at the
effects of various diseases on the potential years of life lost before
age 75. He noted that while heart disease is the single largest cause
of death in developed countries, it usually occurs at older ages. Motor
vehicle crashes and suicides together cause the loss of more potential
years of
[[Page 10084]]
life in men than heart disease, and both are linked to alcohol use. In
women, breast cancer and motor vehicle accidents each account for more
potential years of life lost before age 75 than heart disease. (May 23,
2000; San Francisco, CA, pages 53-54).
Dr. Criqui also stressed the importance of evaluating the patterns
of consumption among drinkers. He said that in the United States, about
80% of men and 70% of women drink alcohol, with 50% of drinkers
reporting temporary problems with alcohol. (Id. at page 55). About 10%
of men and 5% of women are alcoholics. Furthermore, Dr. Criqui stated
that ``half of all the alcohol consumed in the United States is
consumed by the 10% of men and the 5% of women who are alcohol-
dependent.'' (Id. at page 57).
Other medical professionals stressed the health benefits associated
with moderate drinking for persons who do not belong in the categories
of individuals for whom alcohol consumption is contraindicated. Dr.
Curtis Ellison, a Professor of Medicine, testified that ``science
clearly indicates that moderate drinkers have much lower risk of
coronary heart disease and ischemic stroke. Because these are the
number one and number three causes of death, it is not surprising that
moderate drinkers will live longer in the United States.'' (April 26,
2000; Washington, DC, page 109). Dr. Ellison suggested that ``if I am
withholding from a patient information that may reduce that
individual's risk of a heart attack by 30 or 40 percent and do not tell
him about it, I am doing him a disservice.'' (Id. at page 110).
B. Decision
The evidence presented by the medical experts, as well as the
studies presented with some of the comments, indicate that there are
differences of opinion as to how the relative risks and benefits of
alcohol consumption should be weighed. The evidence reflects a broad
consensus that heavy levels of alcohol consumption pose serious health
risks. The record also reflects that there is a broad consensus that
certain categories of people should not consume any alcohol. With
regard to those individuals for whom alcohol consumption is not
contraindicated, there was some difference among the experts as to how
to weigh the relative risks and benefits of moderate consumption, with
some experts stressing the protection against cardiovascular disease,
and other experts stressing the increased risk of injury and certain
cancers.
Because TTB is not an expert on public health issues, we (and our
predecessors) have generally deferred to the findings of the Department
of Health and Human Services, including NIAAA, FDA, CSAP, and the
Surgeon General, on issues related to the effects on health of alcohol
consumption. In the case at hand, TTB finds that the evidence in the
rulemaking record supports the findings of NIAAA's 1999 ``Alcohol
Alert'' and the 2000 Dietary Guidelines published by USDA and HHS. The
main points of these findings can be summarized as follows:
[sbull] Alcohol beverages are harmful when consumed in excess, and
some people should not drink at all. Excess alcohol alters judgment and
can lead to dependency and many other serious problems. Heavy levels of
alcohol consumption cause social and psychological problems, cirrhosis
of the liver, inflammation of the pancreas, and damage to the brain and
heart.
[sbull] Taking more than one drink per day for women or two drinks
per day for men can raise the risk for motor vehicle accidents, other
injuries, high blood pressure, stroke, violence, suicide, and certain
types of cancer. Even one drink per day can slightly raise the risk of
breast cancer.
[sbull] Alcohol consumption during pregnancy increases the risk of
birth defects.
[sbull] Certain individuals should not drink any alcohol; for these
individuals, even moderate levels of alcohol consumption may cause
health risks. Included in this category are children and adolescents;
individuals of any age who cannot restrict their drinking to moderate
levels; women who may become pregnant or who are pregnant; individuals
who plan to drive, operate machinery, or take part in other activities
that require attention, skill, or coordination; and individuals taking
prescription or over-the-counter medications that can interact with
alcohol.
[sbull] Moderate levels of alcohol consumption are associated with
a reduced risk of coronary artery disease for certain individuals, but
causation has not been conclusively established.
[sbull] To the extent that moderate consumption is linked to a
lowered risk for coronary heart disease, the link appears mainly among
men over 45 and women over age 55. Moderate consumption provides
little, if any, health benefit for younger people.
[sbull] The effects on health of alcohol consumption vary from
individual to individual, depending on the individual's health profile
and history, as well as the levels of consumption. Risk of alcohol
abuse increases when drinking starts at an early age. Some studies
suggest that older people may become more sensitive to the effects of
alcohol as they age.
Based on the above, it is TTB's conclusion that the medical data
still supports ATF's longstanding (and now our) position that
notwithstanding the data linking moderate alcohol consumption to a
reduced risk of heart disease in some individuals, there are
significant health risks associated with all levels of alcohol
consumption. The medical data submitted by the commenters, as well as
the testimony presented by experts at the public hearings, suggest that
there is a link between moderate alcohol consumption and a reduced risk
of heart disease in certain individuals; however, causation has not
been conclusively established. The risk/benefit ratio varies with the
individual's own health profile and the level of consumption. For
example, moderate alcohol consumption confers few, if any, benefits on
people at low risk for heart disease. The evidence also establishes
that there are serious risks associated with higher levels of alcohol
consumption, and that even moderate consumption poses health risks for
certain individuals. Finally, there are certain categories of
individuals for whom any level of alcohol consumption is not
recommended.
XV. Are Health Claims and Health-Related Statements in the Labeling and
Advertising of Alcohol Beverages Inherently Misleading?
A. Comments in Opposition to the Use of Health Claims and/or Health-
Related Statements
Approximately 120 comments opposed the use of health claims and/or
health-related statements (including directional statements) in the
labeling and advertising of alcohol beverages. Many of these
commenters, including the American Medical Association, the American
Cancer Society, and the Center for Science in the Public Interest,
commented in support of a complete ban on the use of such statements in
the labeling or advertising of beverage alcohol. The primary arguments
made by these commenters are summarized below.
1. It Has Not Been Proven That Moderate Alcohol Consumption Lowers the
Risk of Heart Disease
NCADD commented that the evidence for the alleged health benefits
of alcohol consumption was ``far from concrete,'' noting that the 1999
NIAAA report concludes that while there is ``an
[[Page 10085]]
association between moderate drinking and a lower risk of CHD, science
has not confirmed that alcohol itself causes the lower risk.''
``Alcohol Alert,'' National Institute on Alcohol Abuse and Alcoholism,
No. 45, October 1999. (Comment 15). Most other commenters, however,
acknowledged that there was a link or association between moderate
alcohol consumption and reduced risk of heart disease in some
individuals.
2. Because the Negative Health Consequences of Alcohol Consumption
Outweigh the Potential Benefits, Health Claims and Health-Related
Statements Are Inherently Misleading and Should Be Banned
Many of the commenters stated that health claims for alcohol
beverages were inherently misleading because the health risks
associated with alcohol consumption outweigh the purported
cardiovascular benefits. For example, the American Cancer Society
commented in favor of a ban on all health benefit claims and health-
related statements in the labeling and advertising of alcohol
beverages. (Comment 527). They noted that ``[w]hile moderate intake of
alcohol has been shown to reduce the risk of coronary heart disease in
middle-aged adults, 100,000 deaths each year are attributed to alcohol-
related diseases.''
The American Medical Association (AMA) strongly urged ATF to reject
any type of beneficial claim for alcohol products on container labels,
noting that such claims would be misleading, and for many persons,
inaccurate. (Comment 534). AMA stated that ``[w]hile some research
indicates that moderate drinking is associated with a decreased risk of
some diseases, other research shows that such risks actually
substantially increase for certain people.''
Senator Strom Thurmond opposed the use of any health-related
statements on alcohol beverage labels. (Comment 526). He testified that
health claims were inherently misleading because of the serious health
risks associated with alcohol consumption; because the supposed health
benefits of moderate drinking have not been conclusively established;
and because any explanatory statements are simply insufficient to
clarify a misleading health claim. (April 25, 2000; Washington, DC,
pages 14-16).
CSPI argued that health claims are inherently misleading for five
reasons:
(1) There are serious health risks associated with alcohol
consumption, even moderate consumption;
(2) the health benefits of moderate alcohol consumption do not
apply universally, but only to a discrete segment of the population;
(3) there are many groups of people who should abstain from, or
minimize, their consumption of alcohol;
(4) allowing health claims would undermine the Government
warning label; and
(5) explanatory statements are insufficient to clarify a
misleading health claim. (Comment 400).
CSPI noted that researchers for the Centers for Disease Control and
Prevention (CDC) found that, after decreasing during the late 1980s,
alcohol consumption among pregnant women in the United States began to
increase after 1991, and the lead author hypothesized that the
increased consumption might be due to the media attention to the
reports on the health benefits of moderate drinking. At the Washington,
DC hearing, Mr. George Hacker, director of CSPI's Alcohol Policies
Project, testified in opposition to the use of health claims. Mr.
Hacker stressed the health risks associated with even moderate alcohol
consumption, and stated that ``[a]lcohol is a potentially dangerous,
potentially addictive, and potentially deadly drug. Any positive health
statement about such a drug must be presented, if at all, only in a
balanced and non-misleading manner.'' (April 25, 2000; Washington, DC,
page 56).
On behalf of its three million members and supporters, Mothers
Against Drunk Driving (MADD) commented in favor of banning any health
claims or directional statements in the labeling and advertising of
alcohol beverages. (Comment 20). MADD commented that ``[t]he negative
consequences and the risk associated with alcohol consumption greatly
outweigh any purported `health benefits.' '' MADD quoted Gen. Barry
McCaffrey, former Director of the Office of National Drug Control
Policy, as telling an alcohol policy conference in 1997 that,
``Undoubtedly, alcohol is the principal drug abuse problem in America
today.''
MADD also noted that in 1998, 15,935 people were killed in alcohol-
related traffic crashes and an estimated 850,000 were injured. These
alcohol-related crashes result in an annual cost of $114,800,000 in the
United States.
The National Association for Children of Alcoholics commented that
``the health risks of alcohol far outweigh the health benefits'' and
advocated a complete ban on health-related claims on alcohol beverage
containers. (Comment 29). This comment noted that 76 million Americans,
about 43% of the U.S. adult population, have been exposed to alcoholism
in the family. Almost one in five (18%) of American adults lived with
an alcoholic while growing up. Its comment also noted the negative
impact of alcoholism on family and marital relationships, the
association between alcoholism and violent crime and child abuse, and
the devastating impact of alcoholism on the children of alcoholics.
The Marin Institute for the Prevention of Alcohol and Other Drug
Problems (``Marin Institute'') commented in favor of a complete ban on
all health-related statements (other than the required warning
statement) in the labeling and advertising of alcohol beverages.
(Comment 324). The Marin Institute commented that ``[s]tatements
attributing positive health effects to the consumption of alcoholic
beverages (as is the case with the previously approved wine labels) are
misleading and potentially dangerous because media and marketing
messages can be misinterpreted as public health recommendations.'' They
stated that ``[s]implistic and misleading messages about the health
effects of alcohol are dangerous to the health and safety of Americans
and could increase the enormous toll of alcohol-related problems in
this country. Because of the evidence regarding the risks associated
with alcohol consumption, alcoholic beverages should not be held to a
lower standard of accountability regarding health messages than well-
regulated prescription drugs. Banning all health claim-related
statements on labels or in advertising of alcoholic beverages assures
that public health information is accurate and free of potentially
harmful misinformation.''
Other public health organizations strongly urged a ban on health
claims. See, Pacific Drug Policy Institute, Inc. (Comment 34); American
Council on Alcohol Problems (Comment 37); and West Los Angeles Alcohol
Policy Coalition (Comment 384).
Many individuals made similar comments, noting the serious health
risks associated with alcohol consumption. Some shared personal
experiences with alcoholism or alcohol abuse. See comments 23, 28, and
35.
Many of the individuals testifying at the public hearings also
emphasized the human costs associated with alcohol abuse. For example,
Barrett Duke, Ph.D., testified on behalf of the Ethics and Religious
Liberty Commission, the moral concerns agency for the Southern Baptist
Convention. He shared his concerns from the perspective of the faith
community, and noted that ``[m]ost faith communities deal with the
[[Page 10086]]
devastating consequences of alcohol abuse on a regular basis in their
churches, missions, and benevolent ministries. * * * Families have been
destroyed. Lives have been lost. Careers have been ruined. Men and
women have left the ministry as a direct result of alcohol abuse.
Furthermore, alcohol is often a primary contributing component to
poverty, forcing faith communities to use precious limited resources to
assist the alcohol abuser as well as the abuser's intended or
unintended victims.'' (April 25, 2000; Washington, DC, page 151).
Ms. Suzanne Harrington-Cole, Chair of the Vallejo Alcohol Policy
Coalition, testified in favor of a complete ban on the use of health
claims on alcohol beverage containers. She stated that alcohol is
present in more than 50% of all incidents of domestic violence (May 24,
2000; San Francisco, CA, page 245), and noted that ``[w]e do not need a
government sanction on more drinking in the name of health.'' (Id. at
page 243).
3. The Issue Is Too Complex To Be Summarized on an Alcohol Beverage
Label Because the Effects on Health of Alcohol Consumption Vary From
Person to Person
Many of the commenters stated that a summary statement of health
benefits on an alcohol beverage label would mislead consumers because
the effects on health of alcohol consumption vary from person to
person, based on various factors. These commenters also suggested that
the issue was too complex to be summarized on an alcohol beverage
label, rendering all such labeling statements inherently misleading.
Thus, the American Cancer Society noted that the potential health
impact of alcohol consumption varied from individual to individual, and
that a ``brief message on any beverage container cannot provide a
consumer with adequate information to make an informed decision about
drinking `for health related reasons.''' (Comment 527).
NCADD urged ATF to ``prohibit labels and advertisements that make
claims regarding potential health benefits associated with the
consumption of alcoholic beverages, because it would be impossible to
adequately and appropriately convey the negative health consequences.''
(Comment 15). NCADD noted that elderly consumers have special concerns,
and that NIAAA's definition of moderate drinking for women and men over
the age of 65 is no more than one drink a day. They cited a study
showing that among persons older than 65, moderate and heavy drinkers
were 16 times more likely than nondrinkers to die of suicide.\12\
Senator Thurmond also testified that the effects of alcohol
consumption vary from individual to individual, and any clarifying
statement along those lines would ``have to address factors such as
age, sex, family, medical history, diet, weight, and activity.'' (April
25, 2000; Washington, DC, page 16). MADD noted ATF's historic policy of
requiring balance in health claims, and suggested that in ``order to
`appropriately qualify and balance' the alleged health claim benefits
with the negative consequences, the alcohol label would have to be the
size of a billboard and advertising messages would be longer than the
State of the Union Address.'' (Comment 20). Accordingly, MADD suggested
that to avoid misleading consumers, such claims should be banned
entirely.
The United Communities Against Drug & Alcohol Abuse commented that
``[n]o brief message on any beverage container can possibly provide a
consumer with adequate information to make a decision about drinking
`for health-related reasons.''' Instead, they suggested that in order
to balance a health message, ``consumers would need to be provided with
a detailed multi-page document (similar to those now provided by
manufacturers of prescription medication) in order to make [an]
informed choice about whether or not a decision to consume an
alcoholic-beverage for health reasons would be, on balance, a good or a
bad decision.'' (Comment 31). The Marin Institute (Comment 324) agreed,
commenting that ``[d]etailed, balanced and cautionary information about
potential harmful effects would be required (as it is with
advertisements of prescription drugs) in order to offset the
demonstrated confusion of the general public about the health effects
of alcohol. The volume of information needed could hardly be legible if
it were displayed on a bottle of wine or beer.''
4. Even if Moderate Alcohol Consumption Is Linked to a Reduced Risk of
Heart Disease, There Are Safer Ways To Achieve the Same Reduction
Without the Risks Associated With Alcohol Consumption
Many commenters suggested that even if alcohol consumption resulted
in health benefits for certain individuals, there were less risky ways
to obtain those benefits. For example, the Central Nebraska Council on
Alcoholism, Inc. (Comment 14) noted that ``[t]here are simply less
risky ways to attain the same health benefits that consuming small
amounts of alcoholic beverages provide to a limited group of people. It
would be irresponsible for the government to allow a health-claims
statement on alcoholic beverages that urge the most risk laden way of
obtaining those benefits.''
CSPI also suggested that there were safer methods of reducing one's
risk of heart disease, stating that the ``discrete category of people
who may benefit from moderate drinking could also lower their risk of
heart disease by other less risky alternatives, such as quitting
smoking, reducing fat in the diet, getting regular exercise, taking a
daily low dose aspirin, or reducing stress. All of those methods are
much less likely to cause accidents or other health problems than
consuming alcohol, even in moderation.'' (Comment 400).
The Tangipahoa Alcohol and Drug Abuse Council (Comment 24) noted
that consumers often look for ``the easy way out,'' and that many may
believe that drinking alcohol will get the same benefits as an overall
healthy lifestyle. The Pacific Drug Policy Institute, Inc. commented
that ``smoking cessation, good diet, exercise, and stress management
techniques provide cardiac benefits with much lower risk of adverse
consequences. When there are low risk ways to attain the health
benefits attributed to wine, it would appear absurd to allow
advertisement of medicinal value in high-risk alcohol consumption.''
(Comment 34).
Ted Miller, PhD, an economist, testified at the hearings that a
more cost-effective way to obtain the purported benefits associated
with consumption of wine would be to walk a mile, drink a glass of
juice, or eat one cup of vegetables every day. (April 25, 2000;
Washington, DC, pages 179-183).
5. Health Claims and Health-Related Messages Would Be Misconstrued by
Consumers, Particularly Those With a History of Alcoholism or Who Are
Susceptible to Alcohol Abuse Problems, as an Endorsement To Consume or
Abuse Alcohol
Many professionals in the field of addiction medicine commented
that health claims and health-related messages were likely to be
misinterpreted by those most susceptible to problem drinking. Many of
these commenters were particularly concerned with the risk that
recovering alcoholics would use information about the purported health
benefits of alcohol consumption to justify their continued use of
alcohol. For example, a physician who has worked in the alcohol and
substance abuse treatment field for 18 years stated that any message
about purported health benefits sends the
[[Page 10087]]
wrong message to the public, especially the alcohol abuser or
alcoholic. He expressed concern that such a message ``would only
encourage the alcoholic to drink more to `help his heart''' and feared
that ``many current alcoholics who are in total recovery and abstinence
may use this as a justification to begin drinking alcohol again,
thinking they can control it.'' (Comment 381). Another doctor made a
similar point, (Comment 385) as follows:
The American public has become accustomed to warning labels on
harmful products * * *. A label touting health benefits of use of
alcoholic beverages in controlled and low amounts, is likely to be
misinterpreted by problem drinkers, especially by alcoholics, whose
belief systems about their drinking distort reality with respect to
the relative benefits and risks of consumption. * * * I do not deny
the scientific validity of reports of health benefits of consumption
of one glass of wine per day for females or two glasses of wine per
day for males. However, the risk of misinterpretation by the
drinking public is far greater than any public health or public
information benefit that may be alleged to accrue from adding labels
to products that promote health benefits from drinking.
The National Association for Children of Alcoholics (Comment 29)
also suggested that health claims can lead to confusion among children
of alcoholics about the role of alcohol, and can reinforce and
perpetuate the denial process of the alcohol-addicted person.
6. The Use of the Term ``Moderate'' in a Specific Health Claim Would Be
Misleading Unless the Term Is Defined
Many public health organizations commented that the use of the term
``moderate'' in a health claim could mislead consumers who did not
understand the definition of the term. The United Communities Against
Drug & Alcohol Abuse noted that ``moderate'' drinking was poorly
defined. It noted that the Substance Abuse and Mental Health Services
Administration (SAMSHA) study showed that ``virtually all drinkers
define their personal level of consumption as `moderate,' whether they
consume one drink per week or five per day.'' (Comment 31). CSPI also
noted that consumers had varying definitions of the term ``moderate.''
(Comment 400). Rather than recommending moderate consumption, CSPI
suggested that any health claims should provide specific quantities of
alcohol that constitute moderate consumption, including a
recommendation that consumers drink no more than one drink per day.
Nancy Piotrowski, PhD, testified that she had been conducting
research on alcohol consumption for the past 16 years, and is in the
middle of ongoing research on the perceptions of drinkers regarding
moderate alcohol consumption. She noted that previous studies had shown
that perceptions of moderate drinking were clearly related to drinkers'
current drinking patterns and their history of problems relating to
drinking. (May 23, 2000; San Francisco, page 37).
B. Comments in Favor of Health Claims
A few commenters specifically supported ATF's proposal to allow
qualified, detailed and balanced health claims in the labeling and
advertising of alcohol beverages. One comment, from CEI and CA,
specifically supported the use of summary health claim statements
without qualification or disclosure of the adverse effects on health
caused by alcohol consumption. Finally, approximately 45 commenters
supported the general use of health claims with respect to alcohol
beverages.
1. Comments in Favor of Allowing Balanced Health Claims, as Set Forth
in the Proposed Rule
The comments in favor of the substantive health claim provisions of
the proposed rule generally stated that ATF had struck an appropriate
balance in dealing with a difficult issue. For example, the National
Consumers League (NCL), a national nonprofit consumer advocacy
organization that was founded in 1899 to represent consumers in the
marketplace and workplace, recognized the difficult nature of the issue
as follows:
NCL believes that the proposed rule raises a serious public
policy question for which there is no easy answer. NCL understands
ATF's concern as to whether health claims should be permitted on
alcoholic beverages at all. While there is a body of research
showing that moderate consumption of alcohol reduces the risk of
coronary heart disease (CHD), there is also evidence that moderate
drinking may increase the risk of certain cancers. Moreover, as ATF
notes, moderate drinking is risky for certain individuals who are
prone to alcoholism, some of whom may not realize that they are.
Excessive alcohol consumption is unquestionably harmful. Whether a
properly qualified health claim should be permitted on alcoholic
beverage labels is a serious policy question that has been debated
by public health experts for years.
NCL concluded that while it ``has reservations about authorizing any
health claim for alcoholic beverages, we believe a properly qualified
and balanced claim would be of value to many consumers. * * * A
healthclaim that includes the elements specified in the proposed rule
would provide these consumers with useful information.'' (Comment 388).
Two major associations representing the wine industry also
commented in support of the substantive health claims provisions of the
proposed rule. The Wine Institute commented ``that the public should
receive the whole story regarding the responsible consumption of wine
and applaud[ed] ATF's efforts, as reflected in the additional proposed
regulation language, to refine and focus the conditions which must be
met before any substantive claim regarding health benefits can be made
on wine labels or in advertisements.'' (Comment 401).
The AVA also stated it had no objection to the proposed amendment
to the regulations to reflect current ATF policy, noting that ``[a]s
our members have been required to conform to these policies for some
years, converting them to regulation would pose no further hardship.''
(Comment 417).
A comment from the Washington Legal Foundation (WLF) focused
primarily on legal issues, noting that if the rule was properly
implemented, it would pass muster under the First Amendment. (Comment
390). This comment will be discussed further under section XIX.
2. Comment Supporting Summary Health Claims Without Qualification or
Disclosure of Adverse Effects
Only CEI and CA specifically argued in favor of allowing summary
health claims without qualification or disclosure of adverse effects in
the labeling and advertising of alcohol beverages. CEI and CA opposed
ATF's notice on the grounds that it would serve to suppress truthful
and non-misleading speech. (Comment 326). CEI and CA argued that the
cardiovascular and overall health benefits associated with moderate
alcohol consumption are amply supported by the medical evidence, and
summary statements of these benefits are protected by the First
Amendment.
CEI and CA suggested that those individuals who would not benefit
from moderate drinking ``know who they are and are unlikely to be
misled.'' CEI and CA also suggested that the CSAP survey supports a
conclusion that consumers would not be misled by directional
statements, that such statements would not change the drinking patterns
of consumers, and that the population studied understands the risks of
drinking, particularly that drinking is counter-indicated during
pregnancy.
CEI and CA claimed that other Federal agencies have approved
summary health statements without the
[[Page 10088]]
extensive qualifications that would be required under ATF's proposed
rule. As examples, they pointed to health claims approved by FDA for
diets low in saturated fat and cholesterol and diets low in sodium.
They also suggested that the ``balance'' ATF is ostensibly seeking
would automatically be provided by the mandatory health warning
statement on alcohol beverage containers.
The CEI and CA comment suggested that the proposed rule would
result in regulations that violated the First Amendment; thus, the
proposed rule should be withdrawn. At the public hearing, Mr. Ben
Lieberman testified on behalf of CEI and stated that CEI believed that
the rulemaking should result in a ``policy allowing a wide range of
accurate summary statements about moderate drinking and health to
appear on alcoholic beverage labels and ads.'' (April 25, 2000;
Washington, DC, page 119). Mr. Lieberman also suggested that ATF had
not accurately summarized the evidence demonstrating the health
benefits associated with moderate alcohol consumption, but instead
spent ``much of its time identifying and somewhat exaggerating every
conceivable category of individual who is not likely to benefit from
moderate drinking, such as adults too young to be at risk for heart
disease, pregnant women, and recovering alcoholics.'' (Id. at page
120).
In response to a question from the panel, Mr. Lieberman confirmed
that it was CEI's belief that a health claim regarding cardiovascular
benefits, such as ``there is significant evidence that moderate
consumption of alcoholic beverages may reduce the risk of
cardiovascular disease,'' could appear on a label with no disclaimer
and still not mislead consumers. He stated that ``it is well known that
people understand the limitations of advertising and labeling and that
they would be skeptical. They would also read the government warning,
which does at least allude to the other side of this story.'' (April
25, 2000; Washington, DC, pages 133-134).
3. Other Comments in Favor of Health Claims
Approximately 45 comments supported the use of substantive health
claims in the labeling and advertising of alcohol beverages. However,
these commenters did not specifically support the type of summary
health claim advocated by CEI and CA. Instead, they commented in favor
of the general principle that health claims for alcohol beverages are
not inherently misleading. In some cases, it was difficult to determine
whether these commenters meant to support directional statements only
or whether they specifically supported the use of substantive health
claims on labels or in advertisements.
Most of the comments that favored a rule allowing the use of
substantive health claims reflected a general perception that consumers
were entitled to information about potential health benefits associated
with moderate alcohol consumption. For example, one individual
suggested that ``consumers have the right to know and can be trusted to
handle this scientific information.'' (Comment 300). Another comment
supported ``the rights of wineries to list the health benefits of their
product on the labels.'' (Comment 277).
Some of the individuals commenting in favor of health claims
specifically supported the concept that the claims be balanced,
although it was unclear whether they were suggesting that the balance
would come from qualifications in the claims or the required Government
warning statement. For example, one individual stated that ``[i]t is
only fair and proper that the labels on the bottle contain the positive
health benefits as well as the proper health warnings.'' (Comment 143).
Another commenter expressed his support for ``producers of wine to be
able to print both the adverse and the positive effects of consuming
wine.'' (Comment 340).
Many of the commenters suggested that consumers need to be made
aware of health-related information, including the positive and
negative effects of alcohol consumption, in order to make informed
decisions regarding its use. For example, one commenter, a psychologist
and attorney, stated that it was ``necessary to rationally accept that
alcohol has benefits as well as dangers * * *. Since Americans can
easily and legally drink, and most in fact do so, the need to inform
them of the range of drinking consequences and the related drinking
limits for each is both prudent and democratic.'' (Comment 243). A
doctor commented as follows:
It makes more sense to put more information on the label in
order for the consumer to make a better decision. As a physician, I
implore my patients to read labels. There are certainly some
potential health benefits to wine as well as potential downsides in
individuals. (Comment 145).
Two commenters argued that alcohol producers have a First Amendment
right to market the health benefits of alcohol consumption, provided
that such information is presented in a non-misleading manner. However,
neither of these comments suggested that industry members were entitled
to use summary health claims without any qualification or disclosure of
adverse effects. The First Amendment issues raised by these commenters
will be addressed separately in section XIX.
Among the medical experts who testified at the hearings in favor of
allowing health claims or health-related statements on labels or in
advertisements, some specifically noted that consumers should be made
aware of both the risks and purported benefits of moderate alcohol
consumption. For example, Dr. Ellison suggested that an appropriate
message on a label would be `` `[w]hile light to moderate alcohol
consumption can be consistent with a healthy lifestyle for most
individuals and has been shown to dramatically reduce the risk of heart
disease, certain individuals should not drink at all.' Then, you should
go through the list of the people that we are advising not to drink.''
(April 26, 2000; Washington, DC, page 116).
Finally, Mr. John Hinman testified on behalf of the American Wine
Alliance for Research and Education as well as the Coalition for Truth
and Balance, a group of California wineries. Mr. Hinman suggested that
it was the Government warning statement, rather than the directional
statements, which misled consumers about the health consequences of
alcohol consumption. (May 23, 2000; San Francisco, CA, page 149). Mr.
Hinman was also one of the few individuals responding to ATF's question
about whether it was possible to craft a balanced substantive health
claim. He noted that he had submitted a 664-word statement to ATF for
review in 1993, entitled ``Wine and Health--Behind the French
Paradox.'' (Id. at page 151). Mr. Hinman stated that ``considering that
664 words makes for a very wordy wine label, we seriously doubt whether
any wine maker really has an interest in providing such a statement on
the bottle. However, the statement can and should be available to hand
out to those customers who request more information or are interested
in the subject matter.'' (Id. at page 152). Accordingly, Mr. Hinman
stated he was resubmitting the statement to ATF for review, and later
clarified in response to a question from the panel that he would put
the statement on an application for label approval. (Id. at pages 152,
165).
In response to a question from the panel, Mr. Hinman stated that
neither the American Wine Alliance nor the Coalition for Truth and
Balance was ``interested, to my knowledge, in necessarily using CEI's
proposed label. * * * On the other hand, as a lawyer * * * that's an
absolutely accurate statement that CEI is using on that
[[Page 10089]]
particular thing, and I would support their First Amendment right to
utilize it. It's going to be up to them to find people that are, in
fact, going to use it.'' (Id. at page 167).
C. Decision
After careful consideration of the record, TTB finds that the
comments and testimony on this issue establish that the use of health
claims in the labeling or advertising of alcohol beverages has the
potential to mislead consumers as to the very serious health
consequences associated with alcohol abuse and consumption. In
particular, TTB finds that the rulemaking record overwhelmingly
supports the conclusion that the type of detail, qualification, and
balance required by the proposed rule would be necessary to avoid
misleading consumers about the serious health risks associated with
alcohol consumption.
Based on the comments on this issue, however, TTB is adopting
certain changes to the final rule to set forth more specifically how a
substantive health claim would comply with the requirements of the
regulation. For example, TTB agrees with the NCADD comment that it has
not been proven that alcohol itself lowers the risk of heart disease in
certain people; this comment is consistent with the 1999 ``Alcohol
Alert'' published by NIAAA. The 2000 Dietary Guidelines state only that
``[d]rinking in moderation may lower risk for coronary heart disease,
mainly among men over age 45 and women over age 55.'' The final rule
provides that a specific health claim would not be approved unless it
is truthful and adequately substantiated by scientific or medical
evidence. Thus, TTB would not approve any claim implying that alcohol
consumption itself caused a reduced risk of heart disease in the
absence of scientific or medical evidence substantiating such a claim.
TTB also agrees with those commenters who suggested that the
effects on health of alcohol consumption vary from person to person,
and that any labeling or advertising statement that failed to take this
into account would mislead consumers. Consistent with the 2000 Dietary
Guidelines, many commenters noted that moderate consumption provided
little, if any, health benefit for younger people, who are at low risk
of heart disease. As noted above, the Dietary Guidelines provide that
``[d]rinking in moderation may lower risk for coronary heart disease,
mainly among men over age 45 and women over age 55.''
In consideration of these comments, the final rule specifically
provides that a claim will not be approved unless it is sufficiently
detailed and qualified with respect to the categories of individuals to
whom the claim applies. For example, assuming that the evidence
continues to indicate that the potential health benefits associated
with moderate alcohol consumption are mainly associated with men over
age 45 and women over age 55, then the claim would have to specifically
set forth this qualification. Furthermore, the concerns expressed in
the comments regarding the definition of the term ``moderate'' would
also be addressed by requiring, where necessary, sufficient detail in
the claim itself regarding the meaning of this term. This level of
detail could include specific information as to what constitutes
``moderate'' levels of consumption, possibly including separate
definitions for men, women, and the elderly.
Many commenters suggested that there are safer ways to reduce the
risk of heart disease without the negative health consequences
associated with alcohol consumption. Again, this is a point noted in
the 2000 Dietary Guidelines, which remind consumers that ``there are
other factors that reduce the risk of heart disease, including a
healthy diet, physical activity, avoidance of smoking, and maintenance
of a healthy weight.'' In reviewing whether a health claim tends to
mislead consumers, TTB will certainly consider whether the health claim
misstates the role played by these factors in reducing one's risk of
heart disease.
Several commenters suggested that any health claim might be
misinterpreted by alcoholics and other abusers of alcohol as a
rationalization for their own consumption levels. TTB recognizes the
possibility that certain consumers will selectively interpret data
regarding the health consequences of alcohol consumption to justify
their own behavior. We believe that summary health benefit claims that
do not disclose the adverse health consequences of alcohol consumption
would be particularly susceptible to this type of misinterpretation. We
recognize the possibility that certain abusers of alcohol may use
information regarding the potential cardiovascular benefits of alcohol
consumption to justify alcohol abuse that clearly poses significant
health risks. However, it is our conclusion that the best way to
prevent this type of misinterpretation of a health claim, by both
alcohol abusers as well as consumers who do not abuse alcohol, is to
require detailed information regarding the health risks associated with
various levels of alcohol consumption.
Accordingly, the final rule provides that a specific health claim
must adequately disclose the health risks associated with both moderate
and heavier levels of alcohol consumption. It is misleading to imply
that moderate alcohol consumption confers only health benefits; the
administrative record establishes that there are significant risks
associated with moderate consumption, including an increased risk of
certain cancers. Even if a claim is made regarding only moderate
consumption, consumers should be advised of the health risks of heavier
levels of alcohol consumption. The record reveals that a high
percentage of the alcohol consumed in this country is consumed at
levels that exceed ``moderate drinking.'' The Marin Institute comment
states that alcohol is consumed at heavy levels (3 or more drinks per
day, or more than 5 drinks at one time) in 78 percent of all drinking
occasions. (Comment 324). Furthermore, Dr. Criqui testified that half
of all the alcohol consumed in the United States is consumed by the 10%
of men and the 5% of women who are alcohol-dependent. (May 23, 2000;
San Francisco, CA, page 57). Finally, a study submitted by CEI and CA
noted that ``[i]n the United States, less than 10% of the population
reports drinking more than two drinks per day, the cutoff for `heavy
drinking' in national survey research. This means that `moderate'
drinkers, because of their much greater numbers, probably account for
well over half of all alcohol problems, a finding that led researchers
at the Institute of Medicine to observe in a groundbreaking report that
`if all the clinically diagnosed alcoholics were to stop drinking
tomorrow, a substantial fraction of what we understand as alcohol
problems would still remain.' ''\13\ These statistics make it clear
that a specific health claim touting the potential health benefits of
moderate alcohol consumption would be misleading without a referral to
the health risks associated with both moderate and higher levels of
alcohol consumption.
In addition, the administrative record establishes that there are
certain categories of individuals for whom any alcohol consumption at
all is not recommended. Accordingly, the final rule provides that any
specific health claim must outline the categories of individuals for
whom any levels of alcohol consumption may cause health risks. The Beer
Institute commented that ATF's proposed standard on this issue made it
unclear whether ``disclaimers
[[Page 10090]]
are required only for categories of individuals whose potential
negative health effects are literally numerous or whether the potential
negative health effects would be aggregated for the purposes of
performing the balancing test envisioned by the proposed regulation.''
(Comment 396). Accordingly, the final rule clarifies that this
requirement is intended to cover the categories of individuals for whom
alcohol consumption is not recommended (e.g., pregnant women,
individuals taking certain medications, etc.).
We do not agree with CEI and CA that it is unnecessary to set forth
this information in conjunction with a health claim because these
people know who they are. For example, it is not at all clear that most
consumers know that alcohol can interact harmfully with a variety of
prescription and over-the-counter medications. It is TTB's conclusion
that any labeling or advertising statement that makes a substantive
health claim regarding alcohol consumption would mislead consumers if
it does not set forth this important information about the adverse
consequences of alcohol consumption. Notwithstanding the above, we find
that the rulemaking record does not support a conclusion that health
claims in the labeling and advertising of alcohol beverages are
inherently misleading. Nor does the record support a conclusion that
the potentially misleading nature of such claims cannot be cured with
the appropriate use of disclaimers and qualifying statements.
Initially, it should be noted that none of the commenters who
supported a total ban on the use of health claims in the labeling and
marketing of alcohol beverages presented consumer data on the use of
substantive health claims in the labeling or advertising of alcohol
beverages. Thus, we have no consumer data establishing that consumers
would be misled by the use of properly qualified health claims that are
sufficiently detailed and specific, and which disclose the adverse
health consequences of alcohol consumption.
A complete ban on the use of health claims or health-related
statements in the labeling and advertising of alcohol beverages would
prohibit even the most qualified, detailed, and balanced discussion of
health consequences in advertising materials. For example, in Industry
Circular 93-8, ATF advised industry members that the regulations did
not prohibit them from including the entire text of NIAAA's April 1992
edition of ``Alcohol Alert'' in advertising materials. This NIAAA
publication presents a comprehensive overview of the benefits and risks
associated with alcohol consumption. If the regulations imposed a
complete ban on advertising materials that included health-related
statements, then industry members would no longer be allowed to include
this NIAAA publication in advertising materials. Yet TTB finds nothing
in the record to establish that the inclusion of this type of
comprehensive discussion of effects on health in an advertisement in
any way misleads consumers as to the health risks of alcohol
consumption. Accordingly, we find that the record does not support an
overall ban on the use of specific health claims and health-related
statements in the advertising of alcohol beverages.
A closer issue is presented by the labeling of alcohol beverages.
As ATF noted in Industry Circular 93-8, we believe that it would be
difficult to compose a health claim that is detailed and specific
enough to meet our standards, yet short enough to fit on a traditional
alcohol beverage label. In addition, TTB will not approve any labeling
health claim that contradicts the message of the required Government
warning statement.
TTB agrees with the commenters who suggested that a summary
substantive health claim which does not include sufficient detail and
qualification would mislead consumers about the serious health
consequences of alcohol consumption. However, we do not believe that
this provides a basis for banning all substantive health claims on
alcohol beverage labels. Instead, as set forth above, TTB is making
changes to the final rule to clearly provide that a specific health
claim will not be allowed unless it is truthful and adequately
substantiated by scientific or medical evidence; sufficiently detailed
and qualified with respect to the categories of individuals to whom the
claim applies; adequately discloses the health risks associated with
both moderate and heavier levels of alcohol consumption; and outlines
the categories of individuals for whom any levels of alcohol
consumption may cause health risks.
We disagree with the arguments made by CEI and CA, the only
commenters who specifically favored allowing industry members to make
summary statements regarding health benefits that contained no
qualification, balance, or disclosure of adverse effects. In the first
place, the record did not establish that there was any concrete
interest on the part of the alcohol beverage industry in using the
summary health claim proposed in the CEI petition. Secondly, we find
that statements such as the one proposed by CEI would mislead consumers
by not disclosing the significant adverse effects on health associated
with alcohol consumption, which are set forth in great detail in this
rulemaking record.
TTB has not drafted a model health claim for use on alcohol
beverage labels because this extensive rulemaking record has revealed
little, if any, interest on the part of industry members in using
substantive health claims on alcohol beverage labels. In fact, industry
members not only failed to express such an interest, in many cases,
they specifically disavowed any interest in using substantive health
claims. Furthermore, as discussed further in section XVIII, any such
claim might well subject the product to regulation as a drug under FDA
regulations.
Accordingly, TTB will leave it to any interested industry members
to seek approval of a substantive health claim through the label
approval process. The final rule sets forth the standards that would
apply to any such labeling statement. If an industry member wishes to
use a substantive health claim on a label in compliance with the
standards set forth in the final rule, it should apply for a
certificate of label approval.
ATF announced in Industry Circular 93-8 that dissemination of the
full text of the April 1992 edition of ``Alcohol Alert'' as published
by NIAAA, would not be in violation of the regulations. The final rule
does not change this policy. Furthermore, dissemination of the entire
Dietary Guidelines as advertising materials by industry members, or
dissemination of the two pages from the current Guidelines dealing with
alcohol beverages (pages 36 and 37) would not violate the final rule.
Both of these materials provide a comprehensive discussion of the
health consequences of alcohol consumption. The information in these
materials regarding the health consequences of alcohol consumption is
truthful and supported by scientific evidence. The information is
sufficiently detailed, qualified and specific, and sets forth the
health risks associated with both moderate and heavier levels of
alcohol consumption. Both of these publications further set forth the
categories of individuals for whom any level of alcohol consumption may
pose health risks. Accordingly, these materials comply with the
standards set forth in the regulations.
As ATF stated in Industry Circular 93-8, we will continue to
evaluate any additional text that accompanies these materials, such as
editorializing, advertising slogans, or exhortations to consume the
product, to determine
[[Page 10091]]
whether or not the advertisement as a whole presents truthful and non-
misleading information regarding the risks associated with alcohol
consumption. Furthermore, the use of any buttons, shelf talkers, table
tents, and similar items that excerpt any portion of the NIAAA
publication or the Dietary Guidelines, or that are based on any other
publication or article about the health consequences of alcohol
consumption, will be closely scrutinized to determine if they tend to
mislead consumers about the serious risks associated with alcohol
consumption.
XVI. Are Health-Related Directional Statements Misleading?
As previously noted, the vast majority of the commenters addressed
the issue of health-related directional statements, such as the ones
approved by ATF in 1999, rather than the issue of substantive health
claims. Approximately 355 commenters expressed support for the use of
directional statements on alcohol beverage labels. Many commenters
stated that directional statements are not substantive health claims
and that they merely refer consumers to other sources for information
about the effects on health of alcohol consumption. As such, the
commenters maintain that directional statements are not misleading to
consumers. On the other hand, most of the approximately 120 comments in
opposition to the use of health claims also opposed the use of health-
related directional statements in the labeling and advertising of
alcohol beverages.
A. Comments and Testimony in Favor of the Use of Health-Related
Directional Statements
Most of the comments in support of directional statements shared
the view set forth in the Wine Institute's comment as follows:
Directing consumers to consult with their doctors or to refer to
the Dietary Guidelines regarding the health effects of wine
consumption constitutes a responsible and neutral message. Far from
misleading the public, such statements are designed to educate and
empower each individual to make fully informed choices regarding the
consumption of wine. (Comment 401).
The Wine Institute's comment also stated that health-related
directional statements were ``certainly not misleading because they do
not constitute substantive health claims in the first instance.'' They
cited the CSAP survey, which concluded that the drinking patterns of
88.3% of the participants would not be influenced by directional
statements, with an additional 3.9% indicating they would drink less.
In response to ATF's question of whether the negative consequences
of alcohol consumption and abuse disqualified alcohol beverages from
entitlement to health claims or health-related statements, the Wine
Institute submitted extensive summaries of scientific studies on
moderate consumption of wine and alcohol for the Dietary Guidelines
Review Process. An updated compilation of that submission was attached
to their comment. The Wine Institute stated that it ``fully subscribes
to an open and vigorous dialogue driven by the findings of the
scientific community on the health effects of alcohol consumption.''
The Wine Institute submitted a supplemental comment in which it
stated that it wished ``to underscore how critical it is to make the
distinction between health-related statements and those in which a
substantive claim of health benefits is advanced. A substantial number
of submissions you have received to date appear to blur this crucial
difference and argue against directional labels by incorrectly
classifying such labels as health claims.'' (Comment 401b).
Mr. John DeLuca, President and CEO of the Wine Institute, testified
at both the Washington, DC and San Francisco, California hearings. Mr.
DeLuca stated that he believed that wineries have a First Amendment
right to use the directional label, and pointed to the CSAP survey as
evidence that consumers would not increase consumption as a result of
directional statements. (April 25, 2000; Washington, DC, page 32). He
urged the empowerment of the public through dissemination of
information, and urged that the public should be trusted ``to handle
this information.'' (Id. at pages 32-33).
When asked about substantive health claims, Mr. DeLuca stated that
``we are not trying to sell wine as health food or as a medicine.''
(Id. at page 37). He said that ``we should be erring on the side of
making it as hard as possible for someone to make a health claim. It
really is not the province of the industry to be talking that way. We
want third-party peer review journals research to be what is presented
to the public, not what we put to the public.'' (Id. at page 38). In
response to a question about whether the directional statements were
perceived as health claims, Mr. DeLuca stated that the Wine Institute
had withdrawn its original label submission, which included the phrase
``health benefits,'' because they ``knew it was going to lead to a
cascade of criticism'' and that the phrase ``health effects'' came from
the Appropriations Committee's language in appropriating funds for NIH
and NIAAA to research the effects on health of moderate drinking. (Id.
at page 40).
When asked about consumer reaction to the directional statements,
Mr. DeLuca noted that only 17 companies had received approval from ATF
for using directional statements before the moratorium went into
effect--5 received approval for the Dietary Guidelines statement, and
12 utilized the family doctor statement. (May 23, 2000; San Francisco,
CA, pages 14-15). Mr. DeLuca stressed that the Wine Institute did not
encourage wineries to use the label, noting that ``[w]e always thought
of this as a voluntary option for our members. They were designed
primarily for public policy, not for public relations, a distinction
with an enormous difference.'' (Id. at 15).
The AVA, a trade association of American wineries representing
approximately 600 members, also noted that it had been involved on
behalf of one of its members in the ATF review process for the
directional statements approved in 1999. (Comment 417). AVA stated that
it agreed with the applicant, Mr. Patrick Campbell, that the
directional statement ``makes no claim, pro or con, therapeutic or
curative, true or false. The COLA [certificate of label approval] makes
no claim at all. It merely (and sensibly) encourages consumers to
consult with their family doctor about their personal use of the
product. * * * Since this COLA makes no claim, questions about its
potential to mislead are irrelevant.'' (Comment 417). The President of
AVA, Mr. Simon Siegl, testified at the public hearings in support of a
winery's right to use a directional label. (April 26, 2000; Washington,
DC, page 65).
Many winemakers also commented in support of the use of directional
statements. Some emphasized the neutral content of the directional
statements. The Associated Vintage Group asked ``what can be a better
message than referring them [consumers] to our own government's
nutritional guides or, even better, checking with their doctors.''
(Comment 173). Mr. Kent Rosenblum commented that ``[d]irectional labels
do not constitute health claims, and government survey data indicate no
changes in drinking patterns would occur.'' (Comment 151). He then went
on to note that ``[t]here is a developing scientific consensus that
moderate wine and alcohol consumption can be part of
[[Page 10092]]
a healthy diet and lifestyle for those who choose to drink.''
Other wineries specifically referenced the directional statements
as providing balance to the Government warning statement, or referring
to the ``benefits'' of consumption. For example, De Rose Vineyards
commented that ``[t]he U.S. Dietary Guidelines for Americans
constitutes a responsible and neutral message.'' The winery also stated
that ``[t]here is a very substantial body of scientific data that
verifies the efficacy and healthfulness of moderate wine consumption.
Withholding this most helpful and beneficial information, and instead
only emphasizing the harmful effects of wine consumption, is ludicrous
and ultimately destructive and irresponsible. A forthright balance of
both positive and negative simply educates an informed public and
allows them to make responsible decisions.'' (Comment 172). Two other
wine producers made similar comments (Comments 214 and 387).
Many commenters who did not identify themselves as being part of
the wine industry also supported the directional statements. Some
supported the general concept of directing consumers to the Dietary
Guidelines or their physician for more information about the effects on
health of alcohol consumption. One suggested that ``[t]he wording is
neutral and not positive, thereby serving as education rather than
propaganda.'' (Comment 332). Several commenters referred to the
consumer survey conducted by CSAP as evidence that the statements did
not mislead consumers.
Some commenters argued that consumers have a right to know all the
scientific information available on both the positive and negative
effects of various levels of alcohol consumption, and that such
information allows consumers to make informed decisions regarding
alcohol consumption. For example, one commenter stated that ``people
are generally capable of making sensible decisions, if assisted by
complete information. * * * Moreover, the small minority who do not
make sensible decisions will not be deterred by suppressing the
presentation of accurate, balanced information.'' (Comment 423). An
individual suggested that ``in an era when we all are trying to
eliminate governmental control of those areas of our lives where we can
be treated as adults, it seems odd for you to be against a neutral
statement that wine drinkers should consult their doctors about the
possible health benefits of wine.'' (Comment 136).
Many of the commenters suggested that the directional statements or
other positive health-related statements were necessary to ``balance''
the negative information provided by the Government warning statement.
For example, one commenter supported the directional statements because
the warning statement should be supplemented with ``equally valid''
information ``explaining the benefits and positive effects of
responsible consumption.'' (Comment 296). Another individual supported
the use of ``positive health related statements'' and stated that
``[t]he wine industry deserves to be afforded an opportunity to address
the latest beneficial health aspects of moderate wine consumption, as
outlined in the U.S. dietary guidelines, on its products. The entire
thrust of Government Warning labels has been entirely negative.''
(Comment 240).
Finally, some commenters argued that the Government should
encourage consumers to seek the best advice possible from the most
credible sources available on any health issue. With respect to the
consumption of alcohol beverages, the National Association of Beverage
Retailers suggested that ``[p]hysicians and the U.S. Dietary Guidelines
are among the most credible sources available to give professional,
objective, responsible and balanced advice on an important health
issue.'' (Comment 424).
At the hearings, several doctors testified in support of the
directional labeling statements. Some specifically supported the
statement encouraging consumers to consult with their physician. For
example, Dr. Michael Apstein, a gastroenterologist and liver doctor,
testified that advice regarding alcohol consumption should be targeted
to specific populations rather than generalized for the entire
population. He stated that ``[t]hese are complex issues that can't
easily be summarized on a label that goes on a wine bottle. They need
to be discussed with a person's physician and individualized to that
person's situation. Therefore, I am in favor of a directional label
that advises individuals to discuss this topic with their physicians,
because I am hopeful that a directional label will stimulate another
kind of educational experience, so people can use alcohol responsibly
if they so desire and avoid it if they should be avoiding it.'' (April
25, 2000; Washington, DC, page 167).
Similarly, Dr. Harvey Finkel, a physician and clinical professor of
medicine, testified that both directional statements should be allowed,
stressing the importance of advising consumers to consult their
doctors, because the public has a right to be fully informed about the
health consequences of alcohol consumption. (April 26, 2000;
Washington, DC, pages 30-33). Mr. George Linn, a consumer, also
testified in support of the concept of referring consumers to their
physicians for more individualized advice about alcohol consumption.
(May 24, 2000; San Francisco, CA, page 256). On the other hand, Dr.
Paul Scholten, an associate professor of obstetrics, gynecology,
reproductive medicine, and nursing, testified in support of the
directional statement referring consumers to the Dietary Guidelines,
but expressed concerns about whether doctors were well trained to
advise patients about the health consequences of alcohol consumption.
(May 23, 2000; San Francisco, CA, pages 170-171).
Some individuals commented in support of the general concept of
directional statements. Dr. Dwight Heath, a Professor of Anthropology,
testified that while he opposed the use of substantive health claims,
he favored the use of the directional statements on labels. (April 26,
2000; Washington, DC, page 13). Dr. Heath suggested that the more
people know about alcohol consumption, the less likely they are to have
alcohol-related problems. (Id. at page 5). Similarly, Professor R.L.
Williams, of the Oenological Research Facility of Old Dominion
University, stated that in his opinion, ``the level of scientific
information regarding the positive health effects of moderate
consumption of wine is now quite overwhelming. * * * This information
should be made more available to the consumers in regard to the
directional health statements.'' (April 26, 2000; Washington, DC, page
91). Mr. Archie Brodsky, a senior research associate in psychiatry and
the law, testified in favor of the use of directional statements on
alcohol beverage labels. He stated that the CSAP survey confirmed that
the labels would have a ``negligible'' influence on consumers''
drinking habits. (April 26, 2000; Washington, DC, page 171).
Mr. Patrick Campbell of Laurel Glen Winery, who submitted the first
directional statement to ATF for approval in 1995, testified on behalf
of the Coalition for Truth and Balance. Mr. Campbell stated that
discussion of the health benefits or risks of alcohol consumption was
not relevant to a discussion of the directional statements, since ``the
approved messages do not constitute health-related statements or make
substantive claims regarding health benefits.'' (May 23, 2000; San
Francisco, CA, page 75). He asserted that the message encouraging
consumers to consult with their family doctors ``is neither true nor
false. It makes no claim
[[Page 10093]]
* * * positive or negative, therapeutic or curative, pro or con.'' (Id.
at 76). Mr. Campbell argued that the message was not misleading in that
it ``presumes nothing. It presupposes nothing. It in no way directs the
outcome of any consultation the consumer may or may not undertake with
his or her family physician. For all the winery knows, the doctor might
tell all of his or her patients never to touch the stuff * * *. It's a
thoroughly neutral and impartial message.'' (Id. at 76-77).
Mr. Campbell expressed surprise at the controversy over the
message, and said he would have expected that ``every health
professional and governmental agency in the country would welcome it. *
* * After all, if you can't trust your family doctor for truthful and
not misleading advice on health issues who can you trust?'' (Id. at
78). Mr. Campbell noted that the American Heart Association ``publishes
a section on alcohol in their dietary guidelines that explicitly
recommends that patients consult with their personal physician on
questions of alcohol use * * *.'' (Id. at 80).
Mr. Campbell stated that on June 3, 1999, before the moratorium on
approving directional statements went into effect, ATF approved a
version of the directional statement which omitted the language about
``the proud people who made this wine'' and instead read as follows:
``We encourage you to consult with your family doctor about the health
effects of wine consumption.'' (Id. at page 74). He stated that he now
preferred this version, since he believes that it fits better in the
label, it's not pompous, and it was an appropriate response to the
people who argued that the ``proud people'' language constituted an
implicit endorsement of alcohol consumption. (Id. at page 87).
In response to a question from the panel, Mr. Campbell stated that
he had gotten no feedback from consumers as to how they viewed the
directional statements. He said that ``[n]obody's said anything, it's
unbelievable. I mean, it cost a lot of money to put these on the
label.'' (Id. at page 88).
Mr. Jack Stuart testified on behalf of the Napa Valley Vintners
Association. He stated that ``we think that the directional warning is
a good thing. We don't consider it to be a positive health claim. If
you take out the phrase 'proud people,' certainly it's a neutral
statement, it's simply a way of getting information, and we think it's
a good idea for anyone who is proposing to drink, or who does drink, or
who does any other thing having to do with food, their diet, their
lifestyle, to consult their physician about the choices they make in
that regard.'' (May 24, 2000; San Francisco, California, page 200). In
response to a question from the panel, Mr. Stuart suggested that ``to
have a balanced message, to me the ideal would be to somehow combine
both the warning and the directional message.'' (Id. at page 210).
Mr. Mark Chandler, the Executive Director of the Lodi-Woodbridge
Winegrape Commission, also testified in favor of the directional
statements. He stated that ``[g]rowers and wineries have no intention
to market their products as health food. But, unlike other food
products, we are prevented by regulation from even mentioning our
product's positive health attributes, thus the need for directional
labels.'' (May 24, 2000; San Francisco, CA, page 250). Mr. Gordon
Murchie testified on behalf of the Virginia Wineries Association in
favor of the use of directional statements, calling them public service
announcements that ``direct the concerned citizen to another source of
professional non-biased, balanced information.'' (April 26, 2000;
Washington, DC, page 78). In response to a question from the panel, Mr.
Murchie said his members would be interested in using directional
statements on labels, but were reluctant to do so until they saw that
the statements were accepted by the Government and the public. (Id. at
pages 86-87).
Dr. Ellen Mack, a physician and part owner of a winery, testified
that ``[i]f wine were considered a medication--and I'm not at all
advocating that it should be--it would be like most other medications,
the dose is critical. Too little may not have the desired effect, and
too much can be dangerous or even deadly.'' (May 23, 2000; San
Francisco, CA, page 132). Dr. Mack suggested that ``the directional
wine labels are effective agents in that the sources of information--
the U.S. Dietary Guidelines and personal physicians--will clearly make
the point that the beneficial health effects result from moderate
consumption of alcohol, and these sources will define moderate as no
more than one drink per day for women and no more than two drinks per
day for men.'' Id.
Various other individuals testified in favor of the directional
statement. For example, Ms. Annette Shafer, author of ``The Wine Sense
Diet'' testified in favor of a ``more balanced message on the bottle,''
suggesting that the warning label is ``very one-sided.'' (May 24, 2000;
San Francisco, CA, page 212).
B. Comments and Testimony in Opposition to Directional Statements
Public health organizations and other commenters raised the
following specific objections to the use of directional health-related
statements in the labeling and advertising of alcohol beverages.
1. Directional Statements Are Implicit Health Claims That Reinforce the
Inaccurate Perceptions of Consumers About Alcohol and Health
CSPI commented that the directional statements were actually
implied health claims. Its comment argued that the ``reference to the
'health effects of wine consumption' offers no useful information, but
simply reinforces existing inaccurate knowledge about the health
benefits of alcohol consumption, as spread through the media and the
wine industry's misleading publicity campaign, and implies that those
benefits are substantial and universal.'' (Comment 400).
The American Cancer Society noted that ``[w]ith the publicity in
the past few years about the health benefits of consuming alcoholic
beverages, any less-detailed claim or reference to health impacts or
benefits might be interpreted by the uninformed consumer as a
suggestion that people should drink alcohol for their health.
Sufficient information is needed to allow consumers to make a well-
educated decision regarding their risk from consumption of this
product.'' (Comment 527). Accordingly, the American Cancer Society
concluded that directional labels ``may mislead the general public
regarding the health benefits of alcohol consumption by providing
inadequate information regarding the risks.''
Senator Thurmond commented that the directional statements were
inherently misleading. He stated that it was unlikely that consumers
who read the directional statements would actually send for the Dietary
Guidelines or consult their physicians. Instead, Senator Thurmond
suggested that ``consumers may be left with the impression that these
statements refer to studies that suggest drinking alcohol may have some
positive health benefits.'' He noted that ``[t]his impression may
reinforce inaccurate assertions about the health benefits of alcohol
consumption spread through the media. These statements may also be
inappropriately viewed as the government's endorsement of drinking.
However, any suggestion that the government endorses drinking for
health reasons is false.'' (Comment 526).
[[Page 10094]]
2. Directional Statements Undermine the Mandatory Government Warning
Statement and May Be in Violation of the Alcoholic Beverage Labeling
Act
NCADD's comment stated that the directional statements approved by
ATF in 1999 ``are misleading and potentially confusing to consumers in
juxtaposition to the federally mandated government warning on all
alcoholic beverage containers sold in the United States.'' (Comment
15). Similarly, MADD commented that ``[t]he public and particularly
youth are being given a mixed message with the inclusion of `health
messages' in alcohol advertising and on warning labels and the net
result is consumer confusion.'' (Comment 20). MADD also noted that
``[w]arning labels on alcoholic beverages were created for a specific
purpose--to make the consumer aware of the potential harm they could
suffer as a result of the use or abuse of the product.''
The United Communities Against Drug & Alcohol Abuse commented that
``Congress has already required a warning statement on alcoholic-
beverage containers. Any other reference to health impacts or benefits
is likely to confuse consumers and undermine the impact of the existing
warning statement.'' (Comment 31). The American Council on Alcohol
Problems urged ATF ``not to contribute to confusion by allowing any
insinuation of health benefits from alcohol consumption.'' (Comment
37).
Dr. Thomas Greenfield, a psychologist, testified in opposition to
the use of health-related statements. He stated he was principal
investigator of the Impact of Alcoholic Beverage Warning Labels
Research Project from 1991-1997. He stated that research showed that
the mandatory Government warning statement had ``fragile but beneficial
effects'' and that ``one must be concerned that a vague health effects
message, by implication positive, may wipe out the small gains in
reminding the public of situational hazards of drinking when driving or
pregnant, and also the health risks.'' (May 24, 2000; San Francisco,
CA, pages 182-183). He suggested that in order to be truly neutral, a
directional statement ``should have a tone that would be to look at the
health risks and health benefits, and potential health benefits. And
one would have to do it in such a way that it emphasized that--which
is, we believe, strongly the case--that the health benefits [are] * * *
relatively small in comparison to the health harms.'' (Id. at page
191).
CSPI commented that if ATF allowed any health claim or health-
related statement on a label, it ``should be worded and displayed in a
manner that does not overshadow, contradict, or undermine the
government warning label. For example, the claim should appear in the
same type size and style as the government warning label, and should
not contain any claim that contradicts any of the statements in the
warning label.'' (Comment 400).
Senator Thurmond testified that the purpose of the ABLA was to
provide ``a clear, non-confusing reminder of the health hazards
associated with alcohol consumption.'' (April 25, 2000; Washington, DC,
page 17). Senator Thurmond suggested that ``the two directional
statements which the ATF approved last year dilutes the required
warnings and, worse, may be seen as the government's endorsement of
drinking. As one of the authors of the Alcohol Beverage Labeling Act,
let me stress that the intent of the legislation was to exclude such
misleading statements.'' Id. In response to the First Amendment
concerns raised by some individuals, Senator Thurmond suggested that at
a minimum, ``groups supporting health-related statements should be
required to prove beyond any reasonable doubt that such claims are not
misleading and do not detract from the government warning.'' (Id. at
page 18).
In addition to Senator Thurmond's comment, a letter signed by
Senators Thurmond, Byrd, and Helms supported a ban on all health-
related statements and directional health statements on labels.
(Comment 526). In this comment, the three Senators stated that the
directional statements approved by ATF in 1999 ``dilute the required
government warning and mislead consumers. In fact, these labels might
inappropriately be seen as the government's endorsement of alcohol
consumption.'' The comment also noted the difficulty of presenting a
balanced statement on the effects on health of alcohol consumption on
an alcohol beverage label. The Senators stated that ``Congress has
spoken clearly on this important public health issue. The purpose of
the ABLA should not be subverted.''
3. Directional Statements Are Misleading Because Drinkers Are Unlikely
To Seek Health Information
Many commenters suggested that the directional statements were
misleading because the CSAP consumer survey established that consumers
who read the directional labels were unlikely to seek additional
information from their doctors or send for the Dietary Guidelines. For
example, CSPI argued that ``referring consumers to a government
publication which offers balanced information is only credible if there
is a reasonable likelihood that such referral will in fact result.''
(Comment 400). CSPI suggested that ``according to consumer research,
few people would actually look at or write for the Dietary Guidelines
on the basis of the label language.'' CSPI and others questioned
whether consumers would get complete information from either the
Dietary Guidelines or their doctors.
Similar points were raised in the testimony of Mr. James Mosher on
behalf of the California Council on Alcohol Policy, a nonprofit
membership organization dedicated to promoting public health approaches
to the prevention of alcohol-related problems. Mr. Mosher argued that
the directional labels were inherently misleading and thus did not
constitute protected commercial speech under the First Amendment.
Because the directional statements themselves make no claim about the
effects on health of alcohol consumption, Mr. Mosher suggested that the
key to determining whether they would mislead consumers depends upon
``the sources to be consulted, the likelihood of consumers actually
consulting them, and the possibility that the wording will lead to
consumer confusion, misleading or deceptive impressions.'' (May 23,
2000; San Francisco, CA, page 92).
4. Directional Statements Are Misleading Because Drinkers Are Likely To
Rationalize Their Consumption Patterns
As previously mentioned, several doctors who have been certified by
the American Society of Addiction Medicine commented in opposition to
the use of both health claims and health-related directional statements
in the labeling and advertising of wines. These commenters suggested
that health claims and directional statements could be misconstrued by
problem drinkers in order to rationalize their own levels of
consumption. For example, one doctor suggested that these statements
could be misconstrued by consumers, because ``consumers, especially
those with a vulnerability to alcoholism, may take the message as an
endorsement of excessive drinking.'' Accordingly, he urged that ATF
``prohibit the alcoholic-beverage industry from making these misleading
and potentially dangerous claims.'' (Comment 167).
Another medical doctor urged ATF to rescind approval of the
directional labeling statements, stating that ``[a] brief message on
any beverage container will not provide consumers with adequate
information about use of alcohol for health-related reasons. Due
[[Page 10095]]
to the publicity in the past few years about the health benefits of
moderate alcohol consumption, a brief label may be interpreted by the
uninformed consumer as a government-authorized statement supporting
consumption of alcohol for health benefit.'' (Comment 410).
NCADD also cited the CSAP study as establishing that focus group
members were ``generally aware'' of the reports on positive effects on
health of wine consumption, and that the heavier drinkers were more
aware of the media reports. NCADD suggested that heavy drinkers would
use these ``beliefs'' about the effects on health of wine consumption
to justify their drinking levels. (Comment 15).
Ms. Joan Kiley, coordinator of the Alcohol Policy Network of
Alameda County, testified in favor of a complete ban on health claims
or health-related statements in the labeling or advertising of alcohol
beverages. She stated that the directional statements were inherently
misleading, since they were ``incomplete statements that do not put
research results in their proper context.'' (May 24, 2000; San
Francisco, CA, page 228). Ms. Kiley noted that ``[c]onsumers are not
always aware of the effect that images and attitudes promoted in
advertising have on their own desires.'' (Id. at page 232). In response
to a question from the panel, Ms. Kiley said that in her experience,
people with alcohol problems were ``very skilled at finding good
reasons to drink. They * * * can use a multiple number of reasons to
drink, that might just be another one.'' (Id. at page 239).
5. Directional Statements Could Be Interpreted as the Government's
Endorsement of Alcohol Consumption
The former Surgeon General, Dr. David Satcher, testified that it
was important to ``carefully consider any action, whether it involves
the health warning or claims that could encourage underage drinking or
mislead about the very real, adverse health consequences.'' (April 25,
2000; Washington, DC, page 73). Dr. Satcher stated he was ``concerned
that references to the U.S. dietary guidelines on the labels of certain
wine products could wrongly lead consumers to conclude that consumption
of wine would reduce health risks or that it was recommended by
guidelines or by family physicians. References to alcohol in the
guidelines should not be construed as evidence of health benefits nor
encouragement that consumers drink. * * * In fact, the Public Health
Service does not recommend consumption of alcohol beverages.'' (Id. at
page 74).
The Marin Institute for the Prevention of Alcohol and Other Drug
Problems (Comment 324) suggested that the directional statements
attributed positive effects on health to the consumption of alcohol
beverages, and were thus ``misleading and potentially dangerous because
media and marketing messages can be misinterpreted as public health
recommendations.'' The Marin Institute stated that the ``60 Minutes''
report on the possible heart protective effects of drinking red wine
led to a 44 percent increase in red wine sales. They quoted the
marketing manager of a winery as stating in ``Impact'' magazine in 1997
that information about health benefits was ``increasing consumption
more than anything else.'' Ms. Hilary Abramson testified on behalf of
the Marin Institute at the San Francisco hearing that the so-called
French Paradox (``the apparent coexistence in France of a low heart
disease rate and a diet rich in saturated fat, and the belief that
alcohol [red wine] is the explanation for it'') had been overestimated,
and the French heart disease statistics underestimated. She stated that
after the 60 Minutes Broadcast in November 1991 on the French Paradox,
``sales of red wine in the United States rocketed 44%, and a Gallup
poll showed that 58% of Americans were aware of research linking
moderate drinking to lower rates of heart disease.'' (May 23, 2000; San
Francisco, CA, pages 115-116).
Similarly, the Greater Spokane Substance Abuse Council's Prevention
Center commented that ``[a]ny statement or labeling in reference to
supposed `health benefits' could be construed by an uninformed consumer
population as a government endorsement to consume a likely harmful
product.'' (Comment 32). The American Council on Alcohol Problems also
commented that ``[i]f health claims are allowed on labels or even
implied, many uninformed consumers would interpret this as a government
sanctioned statement suggesting that people drink alcohol for their
health. Quite to the contrary, research clearly shows that any measure
which increases the level of alcohol consumption will result in
increased levels of disease and accidents.'' (Comment 37).
6. Other Testimony Against Directional Statements
Many of the medical experts who testified at the public hearings
expressed concerns that the directional statements would mislead
consumers about the effects on health of alcohol consumption. For
example, Dr. Camargo concluded that ``with all of these variety of
factors influencing the net health effect of alcohol, I think it is
really quite foolhardy to believe that any one-sentence generic health
claim about moderate wine consumption would serve public-health
interests, or even provide reliable consumer advice. In addition to the
gross simplification of a complex risk/benefit analysis, the labels
will also lead to several other levels of confusion.'' (April 25, 2000;
Washington, DC, page 90). In particular, he noted that few consumers
would actually consult the Dietary Guidelines for information on the
effects of alcohol consumption, that many people who notice the label
would interpret the phrase ``health effects'' as ``healthy effects,''
that there is considerable confusion about what constitutes moderate
drinking, and that if consumers do consult their family physician, ``it
is very unlikely the physician will be in a position to provide
accurate, up-to-date information about all of the risks and benefits of
moderate drinking.'' (April 25, 2000; Washington, DC, pages 91-92). Dr.
Camargo also noted that ``generic health claims are likely to be
misinterpreted by those at greatest risk of alcohol problems, a group
that would likely use the health claim to justify continued or
increased consumption of excessive alcohol with all of its attendant
health hazards.'' (Id. at page 92).
Dr. Criqui also testified that because of the negative health
consequences associated with alcohol consumption and abuse, the
directional statements are inherently misleading. (May 23, 2000; San
Francisco, CA, page 60). He stated that the approved directional
statements appear to implicitly endorse the value of alcohol as a
pharmacological protective agent. (Id. at page 59). Dr. Criqui offered
his opinion that consumers interpret the approved statements as
substantive health claims, which means that at least for most people
drinking is good and has health benefits and that the Government
endorses this position. Because the directional statements are recent
and come in the context of media discussion about the possible benefits
of alcohol consumption, Dr. Criqui stated that the statements are
likely to be interpreted as implicitly endorsing alcohol consumption as
being potentially healthy, since they do not emphasize or even mention
the dangers of alcohol consumption. (Id. at pages 59-60).
Some people suggested that consumers would interpret the
directional statements as making positive health-related claims simply
because of an assumption that the industry would not use the statements
[[Page 10096]]
unless they were positive. For example, Dr. Duke, representing the
Ethics and Religious Liberty Commission, the moral concerns agency for
the Southern Baptist Convention, suggested that the directional
statements were misleading because they ``create an impression of
endorsement of the health claims made by the alcohol industry. * * *
The average person would not conclude that the alcohol industry would
direct people to information damaging to their claim. Consequently, the
average person will assume a doctor would agree that drinking alcohol
is good for one's health.'' (April 25, 2000; Washington, DC, 154-155).
Ms. Diana Conti testified on behalf of the American Public Health
Association in support of a ban on all health-related statements on
labels and in advertisements, other than the required warning
statement. Ms. Conti suggested that the directional statement regarding
the Dietary Guidelines ``provides no specific information, no
definition of moderate drinking, and no cautions to those who should
not drink. The message is confusing and it's contradictory to the
warning label.'' (May 23, 2000; San Francisco, CA, page 106). She
stated that ``[t]he lack of substantive information creates the
impression that the government says moderate wine consumption is good
for your health, and few, if any, will actually read the guidelines for
the more complete information.'' (Id. at page 107).
C. Decision
When ATF approved the directional statements in 1999, it concluded
that the record did not establish that the statements would mislead
consumers about the risks associated with alcohol consumption. ATF
relied heavily upon the CSAP consumer survey, which concluded that the
directional statements would not encourage most consumers to alter
their consumption levels or patterns.
After careful consideration of the comments and testimony on this
issue, it is TTB's conclusion that while the two directional statements
approved in 1999 were worded in a way that was intended to represent a
neutral referral to doctors or the Dietary Guidelines for additional
information, the statements were capable of being interpreted in a very
different fashion. In particular, the statements could be interpreted
as encouraging the consumption of alcohol for health reasons.
While the CSAP survey established that the vast majority of
consumers would not alter their consumption patterns after exposure to
the two directional statements, it did not explore whether consumers
would interpret the statements as encouraging the consumption of
alcohol for health reasons. Since TTB has no consumer data on this
issue, we must rely upon the secondary data that is available to us,
including the opinions of medical and public health experts in the
field of alcohol and health.
Initially, TTB would note that many media reports about approval of
the directional statements referred to these statements as health
claims or references to health benefits. See section VII, infra. We
recognize that these reports only indirectly reflect consumer reactions
to the directional statements, and that they may have been influenced
by the industry's or the public health sector's characterizations of
the statements. Nonetheless, to the extent that these media reports
both reflect and shape the perceptions of consumers, we believe that
these reports are persuasive evidence that the directional statements
are perceived by many as making a positive claim about the effects on
health of alcohol consumption.
We are also persuaded by the opinions of many of the foremost
public health experts in the nation. These public health experts
believe that the allegedly neutral directional statements in fact
communicated a message that the Government endorsed drinking for health
reasons, or that the Dietary Guidelines or a family physician would
endorse the consumption of alcohol for health reasons. For example, the
former United States Surgeon General testified that he was ``concerned
that references to the U.S. dietary guidelines on the labels of certain
wine products could wrongly lead consumers to conclude that consumption
of wine would reduce health risks or that it was recommended by
guidelines or by family physicians.'' (April 25, 2000; Washington, DC,
page 74). Similarly, the American Cancer Society noted that ``[w]ith
the publicity in the past few years about the health benefits of
consuming alcoholic beverages, any less-detailed claim or reference to
health impacts or benefits might be interpreted by the uninformed
consumer as a suggestion that people should drink alcohol for their
health'' and concluded that directional labels ``may mislead the
general public regarding the health benefits of alcohol consumption by
providing inadequate information regarding the risks.'' (Comment 527).
Other commenters, including the American Medical Association and the
Marin Institute, supported a ban on directional statements for similar
reasons.
TTB also finds persuasive the testimony of many of the foremost
experts on the medical research regarding alcohol and health. For
example, Dr. Camargo testified that in his opinion, consumers would
interpret the phrase ``health effects'' to mean ``healthy effects.''
(April 25, 2000; Washington, DC, pages 90-92). Dr. Criqui offered his
opinion that the approved directional statements appear to implicitly
endorse the value of alcohol as a pharmacological protective agent, and
that consumers interpret the approved statements as substantive health
claims meaning that at least for most people drinking is good and has
health benefits and that the Government endorses this position. Because
the directional statements are recent and come in the context of media
discussion about the possible benefits of alcohol consumption, Dr.
Criqui stated that the statements are likely to be interpreted as
implicitly endorsing alcohol consumption as being potentially healthy,
since they do not emphasize or even mention the dangers of alcohol
consumption. (May 23, 2000; San Francisco, CA, pages 59-60).
TTB does not disregard the testimony of those medical
professionals, including Dr. Apstein, Dr. Finkel, and Dr. Scholten, who
testified in favor of the use of directional statements. We agree that
industry members have the right to suggest, in labels or in
advertisements, that consumers refer to third party sources for
additional information regarding the effects on health of alcohol
consumption. The question presented is how to make such referrals
without misleading consumers.
We would also note that many of the comments in favor of the use of
directional statements referred to the need to provide ``balance'' to
the negative message of the health warning statement, and thus
implicitly recognized that the directional statements were meant to
convey a positive message about the effects on health of alcohol
consumption. In this regard, it is noteworthy that in a comment
submitted after the hearings were held, Beer Institute suggested that
the position of several proponents of directional statements that such
statements did not constitute health claims was inconsistent with those
same proponents' attempts ``to defend the directional statements by
relying on well-known published medical literature that attributes
certain health benefits to the moderate consumption of alcohol
beverages. Given the history of this issue and the evidence cited by
supporters of the directional statements, it seems impossible to
characterize the directional statements as anything but health claims
subject to the automatic
[[Page 10097]]
qualifying provisions of the proposed new regulations.'' (Comment
396b).
After careful consideration of the comments and testimony in the
rulemaking record, it is TTB's view that the directional statements
approved in 1999 may be interpreted as advocating the consumption of
alcohol beverages for health reasons. We recognize that producers of
alcohol beverages have contended that they have a constitutionally
protected right to advocate that consumers drink their products for
health reasons. However, if such a claim is made on a label or in an
advertisement, it must be made in a truthful and non-misleading
fashion. Furthermore, such a claim would fall within the category of a
specific health claim, and would be subject to the requirements in the
final rule applicable to such claims. To the extent that producers
instead wish to make a neutral referral to third parties for additional
information regarding the effects on health of alcohol consumption, we
believe that it is necessary to provide a disclaimer that clarifies
that the labeling or advertising statement should not encourage
consumption of alcohol for health reasons.
Accordingly, the final rule provides that directional statements
will not be allowed in the labeling or advertising of alcohol beverages
unless accompanied by a disclaimer. The final rule provides a model
disclaimer that alcohol beverage producers may use in conjunction with
a general statement that directs consumers in a neutral or other non-
misleading manner to a third party for balanced information regarding
the effects on health of alcohol (wine, distilled spirits, or malt
beverage) consumption: ``This statement should not encourage you to
drink or to increase your alcohol consumption for health reasons.'' It
should be noted that in some cases, an acceptable disclaimer might be
incorporated into the language of the directional statement itself;
thus, if the directional statement makes it clear that it is not
advocating consumption of alcohol for health reasons, then an
additional disclaimer may not be necessary.
XVII. Should the Same Standards Apply to Wines, Distilled Spirits, and
Malt Beverages?
A. Issue
The DISCUS comment opposed the Bureau's suggested ``case-by-case''
approach, noting that the effects on health of alcohol consumption
apply across the board to all beverage alcohol products. Accordingly,
DISCUS suggested that public policy and regulatory policy require fair
and equal treatment for each form of beverage alcohol, and any label
statement for a beverage alcohol container should apply equally to each
type of beverage alcohol. (Comment 530).
B. Decision
Both the proposed and final rules make it clear that the same
standards apply to wine, distilled spirits, and malt beverages. The
rulemaking record does not provide a basis for setting forth different
standards for these types of alcohol beverages. The two directional
statements approved by ATF in 1999 were both submitted by wineries, and
thus both referred to the effects on health of ``wine consumption.'' To
the extent that a directional statement complies with the standards set
forth in this final rule, it may be used in the labeling of a wine,
distilled spirit, or malt beverage product.
XVIII. Should TTB Adopt the Procedures Set Forth in FDA's Regulations?
A. Issue
Several commenters suggested that ATF should adopt the substantive
standards already in place in FDA's regulations governing the use of
health claims in the labeling of foods. FDA also raised several
concerns about consistency between ATF's proposed regulations and its
own health claim regulations.
FDA (Comment 327) commented that it was ``imperative that [ATF]
regulate these claims in a manner consistent with the provisions of the
Federal Food, Drug, and Cosmetic Act (FFDC Act) to ensure the
meaningful and non-misleading use of such claims.'' FDA pointed out
that pursuant to the Nutrition Labeling and Education Act (NLEA), a
manufacturer may make a health claim on a food label only if FDA
determines ``based on the totality of publicly available scientific
evidence (including evidence from well-designed studies conducted in a
manner which is consistent with generally recognized scientific
procedures and principles), 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 U.S.C. 343(r)(3)(B)(i).
FDA also noted that the use of claims for foods that may have a
negative health impact generally is not appropriate under the NLEA. The
statute provides that a health claim may not be made for a food that
contains, as determined by regulation, any nutrient in an amount that
increases to persons in the general population the risk of a disease or
health-related condition that is diet-related. 21 U.S.C.
343(r)(3)(A)(ii). FDA may grant an exception to allow foods with
disqualifying nutrient levels to bear a health claim if the claim is
accompanied by a disclosure statement regarding the disqualifying
nutrient and FDA has determined by regulation that such a claim would
assist consumers in maintaining healthy dietary practices. 21 U.S.C.
343(r)(3)(A)(ii) and 343(r)(2)(B). FDA requires rigorous evidence to
support a conclusion that a health claim on a food with a disqualifying
nutrient level would assist consumers in maintaining healthy dietary
practices.
FDA expressed the following concern about the use of health claims
on alcohol beverage labels:
Alcohol beverages are foods for which there is evidence of a
substantial number of undisputed negative health effects. FDA has
not evaluated the evidence supporting the putative health benefits
of alcohol beverages. Therefore, we cannot say whether health claims
for an alcohol beverage would be prohibited under FDA's existing
health claim authorization process, or if not prohibited, could be
authorized with a disclosure statement of the type required by 21
U.S.C. 343(r)(2)(B). We are concerned, however, that the evidence
for the well-known direct causative relationships between alcohol
and numerous health risks would be a significant hurdle to our
concluding that label information about a relationship between
consumption of alcohol and a health claim could assist consumers in
maintaining healthy dietary practices.
FDA also noted that the absence of any significant nutritive value of
alcohol products would be another obstacle to FDA authorizing a health
claim for alcohol beverages.
FDA stated that it was concerned that ``certain therapeutic or
curative claims sought by manufacturers of alcohol beverages may in
fact be claims that would require regulation of the alcohol beverages
as drugs.'' It noted that FDA has authority and responsibility under
the FFDC Act to regulate all products bearing drug claims, and that the
term ``drug'' is defined by statute to include an article ``intended
for use in the diagnosis, cure, mitigation, treatment or prevention of
disease.'' 21 U.S.C. 321(g)(1)(B). FDA concluded that ``[a]lcohol
beverages could fall within this definition if their labeling contains
drug claims.''
FDA expressed a concern that certain health claims that would be
allowed under ATF's proposed rule might render the product a drug
subject to regulation under the FFDC Act. The FFDC Act
[[Page 10098]]
provides that any drug that is not generally recognized by qualified
experts as safe and effective for use under the conditions prescribed,
recommended, or suggested in its labeling, or that has not been used to
a material extent or for a material time under such conditions, is a
``new drug.'' 21 U.S.C. 321(p). A new drug may not be legally marketed
unless FDA has approved a new drug application for such a drug. 21
U.S.C. 331(d) and 355(a). FDA noted that the FFDC Act requires
substantial evidence of effectiveness and evidence that the drug is
safe for its intended use before FDA will approve a new drug
application. 21 U.S.C. 355(d). FDA suggested that this standard
differed from the ``not misleading'' standard proposed by the ATF
notice of proposed rulemaking.
FDA advised that ATF should explicitly articulate in its
regulations the processes by which it would review claims intended for
alcohol beverages. It stated that it was unable to determine, based on
the proposed rule, whether the proposed process for a review of health-
related statements would be consistent with FDA's statutory and
regulatory authorities. Accordingly, FDA urged ATF to clarify the
process and criteria it intends to use to substantiate the validity of
any health claims or other health-related statements before finalizing
the proposed rule.
The former Surgeon General, Dr. David Satcher, also testified in
support of adopting standards ``consistent with that relied upon by the
Food and Drug Administration or for regulated health claims for foods
and drugs.'' (April 25, 2000; Washington, DC, page 77). Accordingly,
``[c]laims should be based on significant scientific agreement, and
they should be qualified to identify those categories of persons for
whom the claims are relevant, as well as to identify those for whom the
negative consequences would outweigh any positive effect.'' (Id. at
page 78). In response to a question from the panel, Dr. Satcher agreed
that there were problems with consumers self-medicating without knowing
all the facts, noting that ``with alcohol, you also have the added
effect that you are dealing with an addictive drug.'' (Id. at page 80).
Senator Thurmond also commented that ``[a]pplication of the FFDC Act to
this issue would appear to prohibit any health-related statements on
alcohol beverage labels. It is absurd that the government would prevent
whole milk from making health-related claims but allow such claims by
alcohol beverages.'' (Comment 526).
CSAP commented that ``[a]lcohol abuse and alcoholism continue to be
among the most vexing public health problems facing the United States.
Indeed, alcohol is the nation's number one drug problem among youth.''
While CSAP did not take a position on any of the issues on which
comment was sought, it noted that ``[o]ne of the key issues challenging
our efforts is the mixed or misleading messages that consumers receive
from a variety of sources. The addition of health related information
on beverage alcohol labels must be carefully considered in relation to
the general public's understanding of alcohol-related health risk.''
(Comment 430).
CSPI suggested that ATF adopt regulations similar to FDA's
regulations under the NLEA, noting that USDA did so on a voluntary
basis for health claims on meat and poultry. CSPI stated that under
regulations similar to those of FDA, health claims would be prohibited
because alcohol consumption increases the risk of other diseases,
noting that ``[t]o allow health claims for alcohol, America's most
devastating drug, while health claims for foods such as whole milk are
prohibited, would be indefensible and would make a mockery of the
federal government's health-claim regime.''
CSPI also noted that if an alcohol beverage label or advertisement
claims that alcohol may reduce the risk of disease, the beverage may be
regulated as a drug by FDA. CSPI argued that, ``aside from its
regulatory classification, alcohol is a drug. Depending on a variety of
factors such as dose and schedule of use, individual metabolism,
personality factors, and situation, alcohol is variously a stimulant
and depressant, euphorigan and soporific, irritant and anxiety reducer.
Alcohol, like other intoxicants, can produce such dependency phenomena
as persistent search behavior, withdrawal, relapse, and loss of
control.''
B. Decision
After giving careful consideration to these comments, and
consulting with FDA, TTB does not agree that its health claim
regulations should be identical to those of FDA. FDA regulations were
promulgated pursuant to a very specific grant of authority by Congress
under the NLEA. Because of the differences in statutory authority, as
well as the differences in the products regulated under these two
statutes, TTB's regulatory scheme for health claim labeling will differ
from FDA's regulatory scheme.
However, TTB agrees with the FDA comment in several respects. Most
importantly, we agree that it is important to ensure that alcohol
beverage producers do not violate the new drug provisions of the FFDC
Act when seeking to use specific health claims on alcohol beverage
labels. It would be where the use of that claim would render the
product subject to FDA's jurisdiction over drugs. Furthermore, FDA's
authority over new drugs has significant public health and safety
consequences. TTB does not wish to create any confusion on the part of
industry members regarding their obligations to comply with FDA's
requirements over drug claims.
In the past, ATF merely advised industry members that they should
be aware of the fact that the use of a health claim on an alcohol
beverage label may subject the product to FDA's jurisdiction. However,
after reviewing the comments on this issue, we met with FDA to discuss
a process whereby TTB and FDA could consult on the use of specific
health claims on alcohol beverage labels. In this way, FDA would have
an opportunity to object to the use of a specific health claim, based
on its jurisdiction over drugs, prior to any TTB action.
Accordingly, the final rule now provides that TTB will consult with
FDA, as needed, on the use of specific health claims on labels. If FDA
determines that a specific health claim is a drug claim that is not in
compliance with the requirements of the FFDC Act, TTB will not approve
the use of such statement on a label. There is no similar provision in
the advertising regulations, since advertisers are not required to
obtain prior approval from TTB. We will of course consult with FDA, as
appropriate, if the question arises as to whether an advertisement is
in violation of the FFDC Act.
XIX. Is the Final Rule Consistent With the First Amendment?
A. Issue
As previously noted, many commenters suggested that the proposed
rule did not comply with the protection accorded truthful and non-
misleading commercial speech under the First Amendment. CEI and CA
argued that ATF is precluded from placing any restrictions on the
dissemination of truthful information about health benefits in the
labeling and advertising of alcohol beverages. Beer Institute, DISCUS,
and NABI suggested that the proposed advertising regulations would
restrict protected commercial speech. Mr. Rex Davis, representing the
President's Forum of the Beverage Alcohol Industry, testified that he
believes the proposed rule violates the First Amendment because it
would
[[Page 10099]]
restrict the industry from communicating the benefits of alcohol
consumption through labels and advertisements. (April 26, 2000;
Washington, DC, pages 133-141). Many other commenters defended the
constitutionality of a complete ban on the use of health-related
statements in the labeling and advertising of alcohol beverages.
Some of the comments that (or commentators who) addressed the First
Amendment issue suggested that while ATF would have authority to
restrict the use of misleading health claims, a complete ban on the use
of health-related statements would be unconstitutional. For example,
the Washington Legal Foundation concluded that an outright ban on the
use of truthful health claims would be unconstitutional, but stated
that the proposed regulations, ``if properly implemented, strike the
appropriate balance in ensuring the First Amendment rights of industry
and consumers, and the dissemination of important information regarding
the health benefits proven to flow from moderate consumption of alcohol
beverages.'' (Comment 390). A comment submitted on behalf of the Oregon
Winegrower's Association also stated that a ban on the use of health
claims on labels or in advertisements would be unconstitutional;
however, the comment stated that the agency should instead ``adhere to
a policy of allowing labeling and advertising claims about such health-
related benefits to be fairly and objectively evaluated for
substantiation, balance and qualification.'' (Comment 380).
A comment from Mr. Erik Bierbauer (Comment 395) attached a copy of
a note that he wrote for the New York University Law Review as a third-
year law student, entitled ``Liquid Honesty: The First Amendment Right
to Market the Health Benefits of Moderate Alcohol Consumption,'' 74
N.Y.U.L. Rev. 1057 (1999). The note concludes that alcohol producers
have a First Amendment right to market the health benefits of moderate
drinking, as long as they do so accurately and include certain limited
disclaimers. Mr. Bierbauer suggested that while such limited
disclaimers would be constitutionally authorized, ``the sort of
disclosure described in ATF's Industry Circular 93-8 probably would be
too burdensome to comply with the First Amendment.'' However, Mr.
Bierbauer's comment suggested that ``[t]he Constitution would permit
the government to require health-related alcohol advertisements and
labels to mention lesser-known risks that are present at moderate
levels of drinking. For example, the government might legitimately
require a disclaimer warning consumers of the possible link between
moderate drinking and breast cancer, and also a statement warning
certain vulnerable consumers not to drink at all.'' Mr. Bierbauer
concluded that ``[a]ds and labels that merely direct the consumer to
other sources of information, such as the wine labels approved by ATF
in February 1999, clearly would enjoy First Amendment protection.''
B. Decision
As set forth in this final rule, TTB is not imposing a complete ban
on the use of health claims or other health-related statements in the
labeling and advertising of alcohol beverages. Accordingly, it is not
necessary to consider whether such a ban would be constitutional.
Instead, the final rule requires TTB to evaluate health claims on a
case-by-case basis to determine if such claims would tend to mislead
the consumer.
The final rule codifies ATF's longstanding position that any
substantive health benefit claim is considered misleading unless it is
truthful and adequately substantiated by scientific or medical
evidence; sufficiently detailed and qualified with respect to the
categories of individuals to whom the claim applies; adequately
discloses the health risks associated with alcohol consumption; and
outlines the categories of individuals for whom any levels of alcohol
consumption may cause health risks. The final rule clarifies that the
identified health risks must include those associated with both
moderate and higher levels of consumption. Thus, the rule would require
any such claim to include appropriate qualifications and disclaimers
about the health risks associated with alcohol consumption. In
addition, health-related directional statements that are not
substantive health claims must nonetheless include a disclaimer to
clarify that the statement does not advocate the consumption of alcohol
beverages for health reasons, or some other appropriate disclaimer to
avoid misleading consumers. The rule's requirements for appropriate
disclaimers and qualifications in order to avoid consumer deception
about a health issue comport completely with the safeguards articulated
by the Supreme Court to protect non-misleading commercial speech.
Commercial speech is defined as speech that proposes a commercial
transaction. Virginia State Board of Pharmacy v. Virginia Citizens
Consumer Council, Inc., 425 U.S. 748, 762 (1976). Information on
alcohol beverage labels is considered commercial speech. Rubin v. Coors
Brewing Co., 514 U.S. 476, 481 (1995). Commercial speech is generally
protected by the First Amendment; however, it enjoys a more limited
measure of protection. Florida Bar v. Went For It, Inc., 515 U.S. 618
(1995). Nonetheless, the Government bears the burden of justifying a
restriction on commercial speech. See Greater New Orleans Broadcasting
Ass'n v. United States, 527 U.S. 173, 183 (1999).
In order to regulate commercial speech, the Government must satisfy
a 4-prong test. Central Hudson Gas & Electric Corp. v. Public Serv.
Comm'n, 447 U.S. 557, 563-566 (1980). First, the expression is
protected by the First Amendment only if it concerns lawful activity
and is not misleading. Second, the Government must establish a
substantial interest. Third, the regulation must directly advance the
governmental interest asserted. Finally, the regulation must be no more
extensive than necessary to serve the interest asserted.
In two recent cases involving alcohol beverages, the Supreme Court
has struck down bans on truthful and non-misleading commercial speech.
In Rubin v. Coors Brewing Co., 514 U.S. 476, 491 (1995), the Supreme
Court applied the Central Hudson analysis in striking down the FAA
Act's prohibition against statements of alcohol content on malt
beverage labels unless required by State law. In 44 Liquormart, Inc. v.
Rhode Island, 517 U.S. 484 (1996), the Supreme Court struck down Rhode
Island's ban on advertising the price of alcohol beverages on First
Amendment grounds. More recently, in Lorillard Tobacco Co. v. Reilly,
533 U.S. 525 (2001), the Supreme Court struck down certain restrictions
imposed by the State of Massachusetts on the advertisement of tobacco
products on First Amendment grounds. However, none of these decisions
restricts the Government's authority to regulate misleading or
potentially misleading commercial speech.
If commercial speech is actually misleading, then it is not
protected by the First Amendment. If commercial speech is potentially
misleading, the Government may regulate such commercial messages if the
restrictions are ``no broader than reasonably necessary to prevent the
deception.'' In re R.M.J., 455 U.S. 191, 203 (1982). Potentially
misleading speech cannot be banned ``if the information also may be
presented in a way that is not deceptive'' through the use of
``disclaimers or explanation.'' Id. Requirements for disclaimers have
been
[[Page 10100]]
upheld as long as the disclaimers are ``reasonably related to the
State's interest in preventing deception'' and do not constitute an
undue burden on the advertiser. Zauderer v. Office of Disciplinary
Counsel, 471 U.S. 626, 651-53 (1985).
TTB recognizes that under the commercial speech doctrine, there is
a preference for disclosure over suppression. See e.g., Zauderer and
Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999). In Pearson, the
Court of Appeals for the D.C. Circuit required the Food and Drug
Administration to consider appropriate disclaimers for health claims on
dietary supplement labels. The Court noted that ``the government's
interest in preventing the use of labels that are true but do not
mention adverse effects would seem to be satisfied--at least
ordinarily--by inclusion of a prominent disclaimer setting forth those
adverse effects.'' 164 F.3d at 659.
Consistent with the Supreme Court cases cited above, as well as the
DC Circuit's ruling in the Pearson case, the final rule requires any
industry member who wishes to make an explicit or implicit health claim
on a label or in an advertisement to make a more complete disclosure of
the adverse effects on health caused by alcohol consumption. The final
rule does not impose any additional requirements on industry members
who do not wish to make such claims. However, given the very serious
health risks associated with alcohol consumption, TTB believes that the
use of health claims without such qualifications and disclaimers would
be misleading to consumers.
The final rule is completely consistent with the preference
expressed by the courts for disclosure over suppression in the
commercial speech arena. The Supreme Court has held that more speech,
not less, is the preferred means of ensuring that consumers have
sufficient information to make informed choices in the commercial
arena. In re R.M.J., 455 U.S. at 203. The final rule does not ``ban''
any type of speech regarding health claims or health-related statements
in the labeling or advertising of alcohol beverages. Instead, the rule
simply requires disclaimers for specific health claims and health-
related directional statements.
CEI and CA suggested that there is no need for disclaimers in
connection with health claims in the labeling or advertising of alcohol
beverages. They point to the fact that the Government warning statement
required on alcohol beverage containers already advises consumers that
``Consumption of alcoholic beverages impairs your ability to drive a
car or operate machinery, and may cause health problems.'' CEI and CA
further suggest that consumers are well aware of the health risks
associated with alcohol abuse, and there is no need to remind them of
such risks.
TTB does not agree with this comment. The administrative record
contains overwhelming evidence of the serious health risks associated
with alcohol consumption. These risks are not merely hypothetical; they
are well documented. Among other things, the comments established that
over 8 million American adults are alcoholics; alcohol is a known human
carcinogen; and alcohol contributes to the deaths of more than 100,000
Americans each year. Furthermore, alcohol abuse has devastating effects
on innocent third parties. In 1998, 15,935 people were killed in
alcohol-related traffic crashes, and an estimated 850,000 were injured.
Mothers Against Drunk Driving commented that the NIH estimated that the
overall societal costs of alcohol abuse and alcoholism in 1995 ($167
billion) were more than 50 percent higher than the costs to society of
illegal drug use ($110 billion). The health risks associated with
alcohol consumption are not simply hypothetical; on the contrary, they
present a serious public health problem in this country. Accordingly,
the record supports a conclusion that a health claim that does not
include information about these serious health risks would tend to
mislead consumers about the health consequences of alcohol consumption.
TTB also disagrees with the suggestion by CEI and CA that health-
related statements presented a necessary ``balance'' to the warning
presented by the mandatory Government warning statement. The warning
statement was intended by Congress to present a clear and nonconfusing
reminder of the health hazards associated with consumption or abuse of
alcohol beverages. See 27 U.S.C. 213. The use of health claims or other
health-related statements without qualification or disclosure of
adverse effects to ``balance'' the mandatory warning statement not only
undermines the intent of the ABLA; it also tends to confuse consumers
about the very real health risks associated with alcohol consumption.
The administrative record contains significant evidence that
truthful statements about certain health benefits associated with
moderate consumption of alcohol beverages for certain individuals will
tend to mislead consumers unless such statements are truthful and
adequately substantiated by scientific or medical evidence;
sufficiently detailed and qualified with respect to the categories of
individuals to whom the claim applies; adequately disclose the health
risks associated with both moderate and heavier levels of alcohol
consumption; and outline the categories of individuals for whom any
levels of alcohol consumption may cause health risks. Most consumers
are unable to conduct or verify health research for themselves to
determine whether a health claim is valid as to their own alcohol
consumption, and are ill equipped to interpret the medical data,
evaluate the potential benefits, or identify and weigh the other
medical factors that may bear upon their individual decision to use
alcohol for therapeutic reasons. See In re R.M.J., 455 U.S. at 202 (the
public's comparative lack of knowledge regarding the product being
advertised is an important factor in determining whether speech is
misleading). A requirement for disclaimers of this nature in such a
situation is clearly directly related to the Government's interest in
ensuring that consumers are not misled by health statements on alcohol
beverage labels.
Some commenters suggested that the types of disclaimers and
qualifications required by the proposed regulations would overly burden
industry members who wish to make health claims about alcohol
consumption, making such requirements unconstitutional. CEI and CA
suggested that ``summary'' health claims for alcohol consumption are
just as truthful as other short health claims allowed by FDA for diets
low in saturated fat and cholesterol, as well as diets low in sodium.
Other commenters suggested that because an alcohol beverage label is
not large enough to include the volume of information necessary in
order to give consumers a complete picture of the effects on health of
alcohol consumption, such statements should be banned completely from
alcohol beverage labels.
TTB agrees that the regulations make it difficult to present a
substantive health claim (for example, one involving cardiovascular
benefits associated with moderate alcohol consumption) on an alcohol
beverage label, because of the level of qualification and explanation
that would be necessary to set forth the risks associated with such
consumption. TTB would also note that there seems to be an overwhelming
lack of interest on the part of the alcohol beverage industry in using
such health claims on alcohol beverage labels. The comments from major
trade associations representing wineries, importers, brewers, and
distillers did not indicate a concrete
[[Page 10101]]
interest in using substantive health claims in the labeling or
advertising of alcohol beverages. One lawyer testified in support of a
664-word labeling statement regarding effects on health and asserted
that members of the wine industry had the right to make such
statements; however, in response to questioning, he conceded that such
a long statement would not be likely to be used on a label.
In the absence of any concrete indications of industry interest in
using substantive health claims on alcohol beverage labels, there is no
reason for TTB to draft a model health claim for use by industry
members. Discussions of whether the regulations would unduly burden the
industry's ability to use qualified and truthful health claims in the
labeling of alcohol beverages will be better informed if and when
industry members submit such statements to TTB for review. Nothing in
the regulation itself indicates that the requirements for qualification
and balance are unduly burdensome. Furthermore, it must be concluded
that the length of any required disclaimers and qualifications are
directly related to the serious health risks associated with alcohol
consumption, rather than any desire by the Government to suppress
speech. In particular, the comparison made by CEI and CA with claims
regarding diets low in saturated fat and cholesterol or diets low in
sodium is not persuasive in the absence of any suggestion that such
diets are associated with the types of documented health risks
associated with alcohol consumption. Accordingly, TTB concludes that
the requirements of the regulations do not unduly burden speech about
the effects on health of alcohol consumption.
Because the directional statements do not make substantive health
claims, but instead have been interpreted as implicitly encouraging the
consumption of alcohol for health reasons, TTB does not believe it is
necessary to require the same level of detail in the disclaimers
required to ensure that such statements do not mislead consumers. In
addition, there clearly is interest on the part of several industry
members in using the directional statements. Accordingly, we have
provided a model disclaimer that may be used by industry members in
conjunction with such directional statements in order to avoid
misleading consumers. This one-sentence disclaimer is not overly
burdensome, and complies with the court cases allowing the Government
to mandate disclosures necessary to prevent consumer deception. TTB
will consider other disclaimers on a case-by-case basis.
Accordingly, the final rule is in accordance with the case law
under the commercial speech doctrine. Because the rule does not ban any
speech, but merely sets forth the type of qualification, detail, and
disclosure required in order to set forth a non-misleading health-
related statement in the labeling or advertising of alcohol beverages,
the rule is completely consistent with the First Amendment protection
accorded truthful and non-misleading commercial speech. On the other
hand, the rule is also consistent with TTB's statutory responsibility
to protect consumers from misleading commercial speech regarding the
serious effects on health of alcohol consumption.
XX. Final Rule
Accordingly, this final rule amends the regulations to provide that
labels and advertisements may not contain any health-related statement,
including a specific health claim, that is untrue in any particular or
tends to create a misleading impression. A specific health claim on an
alcohol beverage label or advertisement will be considered misleading
unless it is truthful and adequately substantiated by scientific or
medical evidence; sufficiently detailed and qualified with respect to
the categories of individuals to whom the claim applies; adequately
discloses the health risks associated with both moderate and heavier
levels of alcohol consumption; and outlines the categories of
individuals for whom any alcohol consumption poses risks. This
information must appear as part of the specific health claim and, in
the case of advertising, must also appear as prominent as the specific
health claim. In addition, TTB will consult with FDA, as needed, on the
use of specific health claims on labels. If FDA determines that a
specific health claim is a drug claim that is not in compliance with
the requirements of the FFDC Act, TTB will not approve the use of such
statement on a label.
The final rule provides that a health-related statement that is not
a specific health claim or a health-related directional statement will
be allowed in the labeling or advertising of alcohol beverages only if
TTB determines that the claim is not untrue in any particular and does
not tend to create a misleading impression as to the effects on health
of alcohol consumption. We will evaluate such statements on a case-by-
case basis and may require as part of the health-related statement a
disclaimer or other qualifying statement to dispel any misleading
impression created by the health-related statement.
With regard to the ``directional'' statements approved by ATF in
1999, we recognize that the producers of alcohol beverages may have a
protected right under the First Amendment to convey the message on
labels and in advertisements that consumers should refer to their
doctors or the Government's Dietary Guidelines for additional
information about the effects on health of alcohol consumption, as long
as that message is conveyed in a fashion that does not mislead
consumers about the health consequences of alcohol consumption. As
discussed above, TTB has also determined that without disclaimers, the
directional statements approved in 1999 tended to mislead consumers
about the health consequences of alcohol consumption.
Accordingly, the final rule provides that a health-related
directional statement is presumed misleading unless it directs
consumers in a neutral or other non-misleading manner to a third party
or other source for balanced information regarding the effects on
health of alcohol consumption and includes as part of the health-
related directional statement a brief disclaimer stating that the
statement should not encourage consumption of alcohol for health
reasons, or some other appropriate disclaimer to avoid misleading
consumers.
As a clarifying change, the final rule uses the term ``health-
related statement'' instead of ``curative or therapeutic claim.''
However, the definition of a ``health-related statement'' in the final
rule incorporates ATF's historic position on what constitutes a
statement of a curative or therapeutic nature, as set forth in the
preamble of it's final rule concerning the labeling and advertising
regulations under the FAA Act (T.D. ATF-180, 49 FR 31667; August 8,
1984). Accordingly, a health-related statement includes any claim of a
curative or therapeutic nature that, expressly or by implication,
suggests a relationship between the consumption of alcohol, wine,
distilled spirits, malt beverages, or any substance found within the
alcohol beverage, and health benefits or effects on health. The term
``health-related statement'' also includes both specific health claims
and general references to alleged health benefits or effects on health
associated with the consumption of alcohol, wine, distilled spirits,
malt beverages, or any substance found within the alcohol beverage, as
well as health-related directional statements. The term also includes
statements and claims that imply that a physical or psychological
sensation results from consuming wine, distilled spirits, or
[[Page 10102]]
malt beverages, as well as statements and claims of nutritional value.
Statements concerning caloric, carbohydrate, protein, and fat content
of alcohol beverages are not considered nutritional claims about the
product. However, statements of vitamin content are considered
nutritional value claims, and will be prohibited if presented in a
fashion that tends to mislead consumers as to the nutritional value of
the product.
The term ``specific health claim'' is defined as a type of health-
related statement that, expressly or by implication, characterizes the
relationship of the alcohol beverage (e.g., wine, distilled spirits, or
malt beverage), alcohol, or any substance found within the alcohol
beverage, to a disease or health-related condition. Implied specific
health claims include statements, symbols, vignettes, or other forms of
communication that suggest, within the context in which they are
presented, that a relationship exists between the alcohol beverage
(wine, distilled spirits, or malt beverages), alcohol, or any substance
found within the alcohol beverage, and a disease or health-related
condition.
The term ``health-related directional statement'' is defined as a
type of health-related statement that directs or refers consumers to a
third party or other source for information regarding the effects on
health of alcohol consumption.
The definitions in the final rule also clarify that TTB is not
expanding its traditional interpretation of a curative or therapeutic
claim to cover, for example, advertisements in which people are shown
relaxing in an enjoyable setting while consuming alcohol beverages.
Accordingly, the final rule in no way impinges on the right of industry
members to advertise their products in a truthful and non-misleading
fashion.
XXI. Applications for and Certificates of Label Approval
Upon the effective date of this final rule, applications for
certificates of label approval must be in compliance with the
regulations. In accordance with the provisions of 27 CFR 13.51 and
13.72(a)(2), upon the effective date of this final rule, certificates
of label approval that are not in compliance with the regulations will
be revoked by operation of regulation. Certificate holders must
voluntarily surrender all certificates that are no longer in compliance
and submit new applications for certificates that are in compliance
with the new requirements.
XXII. Notes 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):342-348, 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(8):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 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.'').
6. Thun, M.J.; Peto, R.; Lopez, A.D.; Monaco, J.H.; Henley,
S.J.; Heath, C.W.; and Doll, R; ``Alcohol Consumption and Mortality
Among Middle-Aged and Elderly U.S. Adults,'' ``The New England
Journal of Medicine,'' 337(24):1705-1714 at 1705, 1997.
7. Id. at 1712.
8. Manson, J.E.; Tosteson, H.; Ridker, P.M.; Satterfield, S;
Hebert, P.; O'Connor, G.T.; Buring, J.E.; and Hennekens, C.H.; ``The
Primary Prevention of Myocardial Infarction,'' ``The New England
Journal of Medicine,'' 326(21):1406-1416 at 1412, 1992.
9. Fuchs, C.S.; Stampfer, M.J.; Colditz, G.A.; Giovannucci,
E.L.; Manson, J.E.; Kawachi, I.; Hunter, D.J.; Hankinson, S.E.;
Hennekens, C.H.; Rosner, B; Speizer, F.E.; and Willett, W.C.;
``Alcohol Consumption and Mortality Among Women,'' ``The New England
Journal of Medicine,'' 332(19):1245-1250 at 1245, 1995.
10. Id. at 1246.
11. Id. at 1249.
12. Grabbe, L; Demi, A; Camann, M.A.; et al. ``The health status
of elderly persons in the last year of life; A comparison of deaths
by suicide, injury, and natural causes.'' ``American Journal of
Public Health'' 87(3):434-437, 1997.
13. Stampfer, M.J.; Rimm, E.B.; Walsh, D.C.; ``Commentary:
Alcohol, the Heart, and Public Policy,'' ``American Journal of
Public Health,'' 83(6): 801-804 at 803, 1993.
XXIII. How This Document Complies With the Federal Administrative
Requirements for Rulemaking
A. Executive Order 12866
TTB has determined that this final 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) 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.
TTB has certified that this final rule will not have a significant
economic impact on a substantial number of small entities. In general,
the final regulations merely clarify TTB's existing policy concerning
the use of health claims in the labeling and advertising of alcohol
beverages and impose no burdens on the industry. With respect to
health-related statements, TTB believes that the burden imposed by the
additional wording required by a disclaimer or other qualifying
statement is minimal. 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 final rule because no requirement to
collect information is imposed.
Disclosure
Copies of the notice of proposed rulemaking, all comments, the
hearing transcripts, and this final rule will be available for public
inspection by appointment during normal business hours at: TTB Public
Reading Room, Room 6480, 650 Massachusetts Avenue, NW., Washington, DC;
202-927-7890.
Drafting Information
The originating drafter of this document is James P. Ficaretta,
Regulations Division, Bureau of Alcohol, Tobacco and Firearms.
[[Page 10103]]
However, personnel from other offices of the Bureau participated in
developing this Treasury decision.
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, TTB amends 27 CFR Parts
4, 5, and 7 as follows:
PART 4--LABELING AND ADVERTISING OF WINE
1. The authority citation for 27 CFR Part 4 continues to read as
follows:
Authority: 27 U.S.C. 205.
2. Section 4.39 is amended by revising paragraph (h) to read as
follows:
Sec. 4.39 Prohibited practices.
* * * * *
(h) Health-related statements. (1) Definitions. When used in this
paragraph (h), terms are defined as follows:
(i) Health-related statement means any statement related to health
(other than the warning statement required by Sec. 16.21 of this
chapter) and includes statements of a curative or therapeutic nature
that, expressly or by implication, suggest a relationship between the
consumption of alcohol, wine, or any substance found within the wine,
and health benefits or effects on health. The term includes both
specific health claims and general references to alleged health
benefits or effects on health associated with the consumption of
alcohol, wine, or any substance found within the wine, as well as
health-related directional statements. The term also includes
statements and claims that imply that a physical or psychological
sensation results from consuming the wine, as well as statements and
claims of nutritional value (e.g., statements of vitamin content).
Statements concerning caloric, carbohydrate, protein, and fat content
do not constitute nutritional claims about the product.
(ii) Specific health claim is a type of health-related statement
that, expressly or by implication, characterizes the relationship of
the wine, alcohol, or any substance found within the wine, to a disease
or health-related condition. Implied specific health claims include
statements, symbols, vignettes, or other forms of communication that
suggest, within the context in which they are presented, that a
relationship exists between wine, alcohol, or any substance found
within the wine, and a disease or health-related condition.
(iii) Health-related directional statement is a type of health-
related statement that directs or refers consumers to a third party or
other source for information regarding the effects on health of wine or
alcohol consumption.
(2) Rules for labeling. (i) Health-related statements. In general,
labels may not contain any health-related statement that is untrue in
any particular or tends to create a misleading impression as to the
effects on health of alcohol consumption. TTB will evaluate such
statements on a case-by-case basis and may require as part of the
health-related statement a disclaimer or some other qualifying
statement to dispel any misleading impression conveyed by the health-
related statement.
(ii) Specific health claims. (A) TTB will consult with the Food and
Drug Administration (FDA), as needed, on the use of a specific health
claim on a wine label. If FDA determines that the use of such a
labeling claim is a drug claim that is not in compliance with the
requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not
approve the use of that specific health claim on a wine label.
(B) TTB will approve the use of a specific health claim on a wine
label only if the claim is truthful and adequately substantiated by
scientific or medical evidence; sufficiently detailed and qualified
with respect to the categories of individuals to whom the claim
applies; adequately discloses the health risks associated with both
moderate and heavier levels of alcohol consumption; and outlines the
categories of individuals for whom any levels of alcohol consumption
may cause health risks. This information must appear as part of the
specific health claim.
(iii) Health-related directional statements. A statement that
directs consumers to a third party or other source for information
regarding the effects on health of wine or alcohol consumption is
presumed misleading unless it--
(A) Directs consumers in a neutral or other non-misleading manner
to a third party or other source for balanced information regarding the
effects on health of wine or alcohol consumption; and
(B)(1) Includes as part of the health-related directional statement
the following disclaimer: ``This statement should not encourage you to
drink or to increase your alcohol consumption for health reasons;'' or
(2) Includes as part of the health-related directional statement
some other qualifying statement that the appropriate TTB officer finds
is sufficient to dispel any misleading impression conveyed by the
health-related directional statement.
* * * * *
3. Section 4.64 is amended by revising paragraph (i) to read as
follows:
Sec. 4.64 Prohibited practices.
* * * * *
(i) Health-related statements. (1) Definitions. When used in this
paragraph (i), terms are defined as follows:
(i) Health-related statement means any statement related to health
and includes statements of a curative or therapeutic nature that,
expressly or by implication, suggest a relationship between the
consumption of alcohol, wine, or any substance found within the wine,
and health benefits or effects on health. The term includes both
specific health claims and general references to alleged health
benefits or effects on health associated with the consumption of
alcohol, wine, or any substance found within the wine, as well as
health-related directional statements. The term also includes
statements and claims that imply that a physical or psychological
sensation results from consuming the wine, as well as statements and
claims of nutritional value (e.g., statements of vitamin content).
Statements concerning caloric, carbohydrate, protein, and fat content
do not constitute nutritional claims about the product.
(ii) Specific health claim is a type of health-related statement
that, expressly or by implication, characterizes the relationship of
the wine, alcohol, or any substance found within the wine, to a disease
or health-related condition. Implied specific health claims include
statements, symbols, vignettes, or other forms of communication that
suggest, within the context in which they are presented, that a
relationship exists between wine, alcohol, or any substance found
within the wine, and a disease or health-related condition.
(iii) Health-related directional statement is a type of health-
related
[[Page 10104]]
statement that directs or refers consumers to a third party or other
source for information regarding the effects on health of wine or
alcohol consumption.
(2) Rules for advertising. (i) Health-related statements. In
general, advertisements may not contain any health-related statement
that is untrue in any particular or tends to create a misleading
impression as to the effects on health of alcohol consumption. TTB will
evaluate such statements on a case-by-case basis and may require as
part of the health-related statement a disclaimer or some other
qualifying statement to dispel any misleading impression conveyed by
the health-related statement. Such disclaimer or other qualifying
statement must appear as prominent as the health-related statement.
(ii) Specific health claims. A specific health claim will not be
considered misleading if it is truthful and adequately substantiated by
scientific or medical evidence; sufficiently detailed and qualified
with respect to the categories of individuals to whom the claim
applies; adequately discloses the health risks associated with both
moderate and heavier levels of alcohol consumption; and outlines the
categories of individuals for whom any levels of alcohol consumption
may cause health risks. This information must appear as part of the
specific health claim and in a manner as prominent as the specific
health claim.
(iii) Health-related directional statements. A statement that
directs consumers to a third party or other source for information
regarding the effects on health of wine or alcohol consumption is
presumed misleading unless it--
(A) Directs consumers in a neutral or other non-misleading manner
to a third party or other source for balanced information regarding the
effects on health of wine or alcohol consumption; and
(B)(1) Includes as part of the health-related directional
statement, and in a manner as prominent as the health-related
directional statement, the following disclaimer: ``This statement
should not encourage you to drink or increase your alcohol consumption
for health reasons;'' or
(2) Includes as part of the health-related directional statement,
and in a manner as prominent as the health-related directional
statement, some other qualifying statement that the appropriate TTB
officer finds is sufficient to dispel any misleading impression
conveyed by the health-related directional statement.
* * * * *
PART 5--LABELING AND ADVERTISING OF DISTILLED SPIRITS
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.
5. Section 5.42 is amended by revising paragraph (b)(8) to read as
follows:
Sec. 5.42 Prohibited practices.
* * * * *
(b) * * *
(8) Health-related statements. (i) Definitions. When used in this
paragraph (b)(8), terms are defined as follows:
(A) Health-related statement means any statement related to health
(other than the warning statement required by Sec. 16.21 of this
chapter) and includes statements of a curative or therapeutic nature
that, expressly or by implication, suggest a relationship between the
consumption of alcohol, distilled spirits, or any substance found
within the distilled spirits, and health benefits or effects on health.
The term includes both specific health claims and general references to
alleged health benefits or effects on health associated with the
consumption of alcohol, distilled spirits, or any substance found
within the distilled spirits, as well as health-related directional
statements. The term also includes statements and claims that imply
that a physical or psychological sensation results from consuming the
distilled spirits, as well as statements and claims of nutritional
value (e.g., statements of vitamin content). Statements concerning
caloric, carbohydrate, protein, and fat content do not constitute
nutritional claims about the product.
(B) Specific health claim is a type of health-related statement
that, expressly or by implication, characterizes the relationship of
the distilled spirits, alcohol, or any substance found within the
distilled spirits, to a disease or health-related condition. Implied
specific health claims include statements, symbols, vignettes, or other
forms of communication that suggest, within the context in which they
are presented, that a relationship exists between distilled spirits,
alcohol, or any substance found within the distilled spirits, and a
disease or health-related condition.
(C) Health-related directional statement is a type of health-
related statement that directs or refers consumers to a third party or
other source for information regarding the effects on health of
distilled spirits or alcohol consumption.
(ii) Rules for labeling. (A) Health-related statements. In general,
labels may not contain any health-related statement that is untrue in
any particular or tends to create a misleading impression as to the
effects on health of alcohol consumption. TTB will evaluate such
statements on a case-by-case basis and may require as part of the
health-related statement a disclaimer or some other qualifying
statement to dispel any misleading impression conveyed by the health-
related statement.
(B) Specific health claims. (1) TTB will consult with the Food and
Drug Administration (FDA), as needed, on the use of a specific health
claim on a distilled spirits label. If FDA determines that the use of
such a labeling claim is a drug claim that is not in compliance with
the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will
not approve the use of that specific health claim on a distilled
spirits label.
(2) TTB will approve the use of a specific health claim on a
distilled spirits label only if the claim is truthful and adequately
substantiated by scientific or medical evidence; sufficiently detailed
and qualified with respect to the categories of individuals to whom the
claim applies; adequately discloses the health risks associated with
both moderate and heavier levels of alcohol consumption; and outlines
the categories of individuals for whom any levels of alcohol
consumption may cause health risks. This information must appear as
part of the specific health claim.
(C) Health-related directional statements. A statement that directs
consumers to a third party or other source for information regarding
the effects on health of distilled spirits or alcohol consumption is
presumed misleading unless it--
(1) Directs consumers in a neutral or other non-misleading manner
to a third party or other source for balanced information regarding the
effects on health of distilled spirits or alcohol consumption; and
(2)(i) Includes as part of the health-related directional statement
the following disclaimer: ``This statement should not encourage you to
drink or to increase your alcohol consumption for health reasons;'' or
(ii) Includes as part of the health-related directional statement
some other qualifying statement that the appropriate TTB officer finds
is sufficient to dispel any misleading
[[Page 10105]]
impression conveyed by the health-related directional statement.
* * * * *
Par. 6. Section 5.65 is amended by revising paragraph (d) to read
as follows:
Sec. 5.65 Prohibited practices.
* * * * *
(d) Health-related statements. (1) Definitions. When used in this
paragraph (d), terms are defined as follows:
(i) Health-related statement means any statement related to health
and includes statements of a curative or therapeutic nature that,
expressly or by implication, suggest a relationship between the
consumption of alcohol, distilled spirits, or any substance found
within the distilled spirits, and health benefits or effects on health.
The term includes both specific health claims and general references to
alleged health benefits or effects on health associated with the
consumption of alcohol, distilled spirits, or any substance found
within the distilled spirits, as well as health-related directional
statements. The term also includes statements and claims that imply
that a physical or psychological sensation results from consuming the
distilled spirits, as well as statements and claims of nutritional
value (e.g., statements of vitamin content). Statements concerning
caloric, carbohydrate, protein, and fat content do not constitute
nutritional claims about the product.
(ii) Specific health claim is a type of health-related statement
that, expressly or by implication, characterizes the relationship of
the distilled spirits, alcohol, or any substance found within the
distilled spirits, to a disease or health-related condition. Implied
specific health claims include statements, symbols, vignettes, or other
forms of communication that suggest, within the context in which they
are presented, that a relationship exists between distilled spirits,
alcohol, or any substance found within the distilled spirits, and a
disease or health-related condition.
(iii) Health-related directional statement is a type of health-
related statement that directs or refers consumers to a third party or
other source for information regarding the effects on health of
distilled spirits or alcohol consumption.
(2) Rules for advertising. (i) Health-related statements. In
general, advertisements may not contain any health-related statement
that is untrue in any particular or tends to create a misleading
impression as to the effects on health of alcohol consumption. TTB will
evaluate such statements on a case-by-case basis and may require as
part of the health-related statement a disclaimer or some other
qualifying statement to dispel any misleading impression conveyed by
the health-related statement. Such disclaimer or other qualifying
statement must appear as prominent as the health-related statement.
(ii) Specific health claims. A specific health claim will not be
considered misleading if it is truthful and adequately substantiated by
scientific or medical evidence; sufficiently detailed and qualified
with respect to the categories of individuals to whom the claim
applies; adequately discloses the health risks associated with both
moderate and heavier levels of alcohol consumption; and outlines the
categories of individuals for whom any levels of alcohol consumption
may cause health risks. This information must appear as part of the
specific health claim and in a manner as prominent as the specific
health claim.
(iii) Health-related directional statements. A statement that
directs consumers to a third party or other source for information
regarding the effects on health of distilled spirits or alcohol
consumption is presumed misleading unless it--
(A) Directs consumers in a neutral or other non-misleading manner
to a third party or other source for balanced information regarding the
effects on health of distilled spirits or alcohol consumption; and
(B)(1) Includes as part of the health-related directional
statement, and in a manner as prominent as the health-related
directional statement, the following disclaimer: ``This statement
should not encourage you to drink or increase your alcohol consumption
for health reasons;'' or
(2) Includes as part of the health-related directional statement,
and in a manner as prominent as the health-related directional
statement, some other qualifying statement that the appropriate TTB
officer finds is sufficient to dispel any misleading impression
conveyed by the health-related directional statement.
* * * * *
PART 7--LABELING AND ADVERTISING OF MALT BEVERAGES
7. The authority citation for 27 CFR Part 7 continues to read as
follows:
Authority: 27 U.S.C. 205.
8. Section 7.29 is amended by revising paragraph (e) to read as
follows:
Sec. 7.29 Prohibited practices.
* * * * *
(e) Health-related statements. (1) Definitions. When used in this
paragraph (e), terms are defined as follows:
(i) Health-related statement means any statement related to health
(other than the warning statement required by Sec. 16.21 of this
chapter) and includes statements of a curative or therapeutic nature
that, expressly or by implication, suggest a relationship between the
consumption of alcohol, malt beverages, or any substance found within
the malt beverage, and health benefits or effects on health. The term
includes both specific health claims and general references to alleged
health benefits or effects on health associated with the consumption of
alcohol, malt beverages, or any substance found within the malt
beverage, as well as health-related directional statements. The term
also includes statements and claims that imply that a physical or
psychological sensation results from consuming the malt beverage, as
well as statements and claims of nutritional value (e.g., statements of
vitamin content). Statements concerning caloric, carbohydrate, protein,
and fat content do not constitute nutritional claims about the product.
(ii) Specific health claim is a type of health-related statement
that, expressly or by implication, characterizes the relationship of
the malt beverage, alcohol, or any substance found within the malt
beverage, to a disease or health-related condition. Implied specific
health claims include statements, symbols, vignettes, or other forms of
communication that suggest, within the context in which they are
presented, that a relationship exists between malt beverages, alcohol,
or any substance found within the malt beverage, and a disease or
health-related condition.
(iii) Health-related directional statement is a type of health-
related statement that directs or refers consumers to a third party or
other source for information regarding the effects on health of malt
beverage or alcohol consumption.
(2) Rules for labeling. (i) Health-related statements. In general,
labels may not contain any health-related statement that is untrue in
any particular or tends to create a misleading impression as to the
effects on health of alcohol consumption. TTB will evaluate such
statements on a case-by-case basis and may require as part of the
health-related statement a disclaimer or some other qualifying
statement to dispel any misleading
[[Page 10106]]
impression conveyed by the health-related statement.
(ii) Specific health claims. (A) TTB will consult with the Food and
Drug Administration (FDA), as needed, on the use of a specific health
claim on a malt beverage label. If FDA determines that the use of such
a labeling claim is a drug claim that is not in compliance with the
requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not
approve the use of that specific health claim on a malt beverage label.
(B) TTB will approve the use of a specific health claim on a malt
beverage label only if the claim is truthful and adequately
substantiated by scientific or medical evidence; sufficiently detailed
and qualified with respect to the categories of individuals to whom the
claim applies; adequately discloses the health risks associated with
both moderate and heavier levels of alcohol consumption; and outlines
the categories of individuals for whom any levels of alcohol
consumption may cause health risks. This information must appear as
part of the specific health claim.
(iii) Health-related directional statements. A statement that
directs consumers to a third party or other source for information
regarding the effects on health of malt beverage or alcohol consumption
is presumed misleading unless it--
(A) Directs consumers in a neutral or other non-misleading manner
to a third party or other source for balanced information regarding the
effects on health of malt beverage or alcohol consumption; and
(B)(1) Includes as part of the health-related directional statement
the following disclaimer: ``This statement should not encourage you to
drink or to increase your alcohol consumption for health reasons;'' or
(2) Includes as part of the health-related directional statement
some other qualifying statement that the appropriate TTB officer finds
is sufficient to dispel any misleading impression conveyed by the
health-related directional statement.
* * * * *
9. Section 7.54 is amended by revising paragraph (e) to read as
follows:
Sec. 7.54 Prohibited statements.
* * * * *
(e) Health-related statements. (1) Definitions. When used in this
paragraph (e), terms are defined as follows:
(i) Health-related statement means any statement related to health
and includes statements of a curative or therapeutic nature that,
expressly or by implication, suggest a relationship between the
consumption of alcohol, malt beverages, or any substance found within
the malt beverage, and health benefits or effects on health. The term
includes both specific health claims and general references to alleged
health benefits or effects on health associated with the consumption of
alcohol, malt beverages, or any substance found within the malt
beverage, as well as health-related directional statements. The term
also includes statements and claims that imply that a physical or
psychological sensation results from consuming the malt beverage, as
well as statements and claims of nutritional value (e.g., statements of
vitamin content). Statements concerning caloric, carbohydrate, protein,
and fat content do not constitute nutritional claims about the product.
(ii) Specific health claim is a type of health-related statement
that, expressly or by implication, characterizes the relationship of
the malt beverage, alcohol, or any substance found within the malt
beverage, to a disease or health-related condition. Implied specific
health claims include statements, symbols, vignettes, or other forms of
communication that suggest, within the context in which they are
presented, that a relationship exists between malt beverages, alcohol,
or any substance found within the malt beverage, and a disease or
health-related condition.
(iii) Health-related directional statement is a type of health-
related statement that directs or refers consumers to a third party or
other source for information regarding the effects on health of malt
beverage or alcohol consumption.
(2) Rules for advertising. (i) Health-related statements. In
general, advertisements may not contain any health-related statement
that is untrue in any particular or tends to create a misleading
impression as to the effects on health of alcohol consumption. TTB will
evaluate such statements on a case-by-case basis and may require as
part of the health-related statement a disclaimer or some other
qualifying statement to dispel any misleading impression conveyed by
the health-related statement. Such disclaimer or other qualifying
statement must appear as prominent as the health-related statement.
(ii) Specific health claims. A specific health claim will not be
considered misleading if it is truthful and adequately substantiated by
scientific or medical evidence; sufficiently detailed and qualified
with respect to the categories of individuals to whom the claim
applies; adequately discloses the health risks associated with both
moderate and heavier levels of alcohol consumption; and outlines the
categories of individuals for whom any levels of alcohol consumption
may cause health risks. This information must appear as part of the
specific health claim and in a manner as prominent as the specific
health claim.
(iii) Health-related directional statements. A statement that
directs consumers to a third party or other source for information
regarding the effects on health of malt beverage or alcohol consumption
is presumed misleading unless it--
(A) Directs consumers in a neutral or other non-misleading manner
to a third party or other source for balanced information regarding the
effects on health of malt beverage or alcohol consumption; and
(B)(1) Includes as part of the health-related directional
statement, and in a manner as prominent as the health-related
directional statement, the following disclaimer: ``This statement
should not encourage you to drink or increase your alcohol consumption
for health reasons;'' or
(2) Includes as part of the health-related directional statement,
and in a manner as prominent as the health-related directional
statement, some other qualifying statement that the appropriate TTB
officer finds is sufficient to dispel any misleading impression
conveyed by the health-related directional statement.
* * * * *
Signed: February 13, 2003.
Arthur J. Libertucci,
Administrator.
February 25, 2003,
Timothy E. Skud,
Deputy Assistant Secretary, (Regulatory, Tariff and Trade Enforcement).
[FR Doc. 03-4836 Filed 2-28-03; 8:45 am]
BILLING CODE 4810-31-P