[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
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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
consum