Federal Register: March 3, 2003 (Volume 68, Number 41)
DOCID: FR Doc 03-4836
DEPARTMENT OF THE TREASURY
Veterans Affairs Department
CFR Citation: 27 CFR Parts 4, 5, and 7
TTB ID: [TTB T.D.-1; Ref: ATF Notice Nos. 884, 892, and 896]
NOTICE: Part II
DOCUMENT ACTION: Final rule, Treasury decision.
SUBJECT CATEGORY:
RIN: 1512-AB97
DATES: This rule is effective June 2, 2003.
DOCUMENT SUMMARY:
TTB is amending the regulations to prohibit the appearance on labels or in advertisements of any healthrelated 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.
Healthrelated statements that are not specific health claims or healthrelated directional statements will be evaluated on a caseby case basis to determine if they tend to mislead consumers. The final rule provides that healthrelated 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.
SUMMARY:
Treasury Department, Alcohol and Tobacco Tax and Trade Bureau,
DOCUMENT BODY 2:
Health Claims and Other HealthRelated Statements in the Labeling
and Advertising of Alcohol Beverages (99R199P)
SUPPLEMENTAL 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 938
IV. Role of Other Federal Agencies With Respect to Specific Health Claims and Other HealthRelated Statements
V. Fourth Edition of the Dietary Guidelines for Americans (1995) VI. Competitive Enterprise Institute Petition
VII. Other HealthRelated 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 HealthRelated Statements on the Labels of Alcohol Beverages?
XIV. What Are the Effects on Health of Alcohol Consumption?
XV. Are Health Claims and HealthRelated Statements in the Labeling
and Advertising of Alcohol Beverages Inherently Misleading? XVI. Are HealthRelated 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. Preapproval 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, * * *.'' FA129, 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 farreaching 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 allcause 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 peoplewho are at high absolute risk of coronary heart disease and ischemic stroke and at low risk for injury, cirrhosis, and other alcoholrelated 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 alcoholrelated diseases but a high absolute risk of dying from injury, allcause mortality will increase even at relatively low alcoholconsumption 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 allcause 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 938
On August 2, 1993, ATF published Industry Circular 938. 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 938, 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 938 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 casebycase basis.
IV. Role of Other Federal Agencies With Respect to Specific Health Claims and Other HealthRelated 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 diseaseprevention 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. 101535 (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 healthrelated 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 healthrelated condition, and the riskincreasing 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 overthecounter 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 HealthRelated Statements on Alcohol Beverage Labels
On February 4, 1999, ATF approved two applications for certificates of label approval bearing directional healthrelated 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 healthrelated 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 healthrelated statement on labels or in advertisements inherently misleading. In addition, ATF sought comments on whether healthrelated 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 healthrelated 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 2526, 2000, and the hearing in San
Francisco was held on May 2324, 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. 451999). 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 alcoholCHD 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 tradeoffs 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 alcoholrelated problems should not exceed the oneto two
drinkperday 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 GuidelinesFifth 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 overthecounter 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 healthrelated 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 healthrelated 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 healthrelated 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, nonmisleading 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 casebycase 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 healthrelated 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 promarket 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 healthrelated 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 nonmisleading 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 healthrelated 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 healthrelated 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 664word 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 healthrelated 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 healthrelated 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 healthrelated 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 healthrelated 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 ``healthrelated
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
HealthRelated 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 healthrelated 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 healthrelated 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 healthrelated 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 welldefined 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 smalltomoderate 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 lighttomoderate 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 lighttomoderate 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 4050 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 alcoholrelated 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 alcoholrelated 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 alcoholrelated 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 7273).
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 healthrelated
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 5354).
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 overthecounter 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 HealthRelated 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
healthrelated 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
i
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 (2029278210).