99-27774. Health Claims and Other Health-Related Statements in the Labeling and Advertising of Alcohol Beverages (99R-199P)  

  • [Federal Register Volume 64, Number 205 (Monday, October 25, 1999)]
    [Proposed Rules]
    [Pages 57413-57418]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-27774]
    
    
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    DEPARTMENT OF THE TREASURY
    
    27 CFR Parts 4, 5, and 7
    
    Bureau of Alcohol, Tobacco and Firearms
    [Notice No. 884]
    RIN 1512-AB97
    
    
    Health Claims and Other Health-Related Statements in the Labeling 
    and Advertising of Alcohol Beverages (99R-199P)
    
    AGENCY: Bureau of Alcohol, Tobacco and Firearms (ATF), Department of 
    the Treasury.
    
    ACTION: Notice of proposed rulemaking.
    
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    SUMMARY: ATF is proposing to amend the regulations to prohibit the 
    appearance on labels or in advertisements of any statement that makes a 
    substantive claim regarding health benefits associated with the 
    consumption of alcohol beverages unless such claim is properly 
    qualified, balanced, sufficiently detailed and specific, and outlines 
    the categories of individuals for whom any positive health effects 
    would be outweighed by numerous negative health effects. ATF is also 
    proposing to prohibit any advertisements that attribute health benefits 
    to the consumption of alcohol beverages unless such statement is 
    appropriately qualified in a manner that is not likely to result in any 
    consumer confusion or deception. This notice seeks comments on whether 
    the negative consequences of alcohol consumption or abuse disqualify, 
    as misleading, these products entirely from entitlement to any health-
    related statements. This notice also seeks comments on whether health-
    related statements on alcohol beverage labels and advertising directing 
    consumers to sources, such as the U.S. Government Dietary Guidelines, 
    of information are misleading and whether ATF should continue to 
    approve such statements.
        The proposed regulations are intended to ensure that labels and 
    advertisements do not contain statements or claims that would tend to 
    mislead the consumer about the significant health consequences of 
    alcohol consumption.
    
    DATES: Comments must be received on or before February 22, 2000.
    
    ADDRESSES: Send written comments to: Chief, Regulations Division; 
    Bureau of Alcohol, Tobacco and Firearms; P.O. Box 50221; Washington, DC 
    20091-0221; ATTN: Notice No. 884. Submit e-mail comments to: 
    nprm.notice.884@atfhq.atf.treas.gov. E-mail comments must contain your 
    name, mailing address, and e-mail address. They must also reference 
    this notice number and be legible when printed on not more than three 
    pages 8\1/2\''  x  11'' in size. We will treat e-mail as originals and 
    we will not acknowledge receipt of e-mail.
    
    FOR FURTHER INFORMATION CONTACT: James P. Ficaretta, Regulations 
    Division, Bureau of Alcohol, Tobacco and Firearms, 650 Massachusetts 
    Avenue, NW., Washington, DC 20226 (202-927-8230).
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background
    
        Under the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 
    205(e) and (f), we are authorized to issue regulations on the 
    packaging, labeling, and advertising of alcohol beverages in order to 
    prohibit deception of the consumer and, without regard to their truth 
    or falsity, statements relating to analyses, guarantees, and scientific 
    or irrelevant matters that are likely to mislead the consumer.
        Regulations that implement the provisions of section 205(e) and 
    (f), as they relate to the labeling and advertising of wine, distilled 
    spirits, and malt beverages, are set forth in Title 27, Code of Federal 
    Regulations (CFR), parts 4, 5, and 7, respectively. Under these 
    regulations, labels and advertisements are prohibited from containing 
    any statement, design, representation, pictorial representation, or 
    device representing that the use of wine, distilled spirits, or malt 
    beverages has curative or therapeutic effects if such representation is 
    untrue in any particular or tends to create a misleading impression. 
    This prohibition originated more than 60 years ago with the initial 
    labeling and advertising regulations issued under the FAA Act.
        ATF and our predecessor agencies have historically taken a very 
    strict view of the regulatory prohibition on curative or therapeutic 
    claims about alcohol beverages. This strict interpretation is based on 
    the view that ``distilled spirits, wines and malt beverages are, in 
    reality, alcoholic beverages and not medicines of any sort, * * *'' 
    (FA-129, dated January 5, 1938).
        In view of the undisputed health risks associated with alcohol 
    consumption, it has always been our position that statements 
    attributing positive health effects to the consumption of alcohol 
    beverages are misleading unless such statements are appropriately 
    qualified and properly balanced.
    
    II. Our Existing Policy Regarding Health Claims and Other Health-
    Related Statements--Summary
    
        The following is a summary of our existing policy with respect to 
    health claims and other health-related statements in the labeling and 
    advertising of alcohol beverages.
        We view statements that make substantive claims regarding health 
    benefits associated with alcohol beverage consumption as making 
    therapeutic or curative claims. Claims which set forth only a partial 
    picture or representation might be as likely to mislead the consumer as 
    those that are actually false. A claim which is supported by scientific 
    evidence may still mislead the consumer without appropriate 
    qualification and detail. Any such claim is considered misleading 
    unless it is properly qualified, balanced, sufficiently detailed and 
    specific, and outlines the categories of individuals for whom any 
    positive health effects would be outweighed by numerous negative health 
    effects.
    
    III. Negative Consequences of Alcohol Consumption
    
        The risks associated with alcohol consumption are well-documented.
        In an article entitled ``Alcohol and Risk of Coronary Events,'' \1\ 
    Charles H. Hennekens, M.D. outlines these risks as follows:
    
        * Endnotes to preamble appear at end of article.
    
        The hazards of heavy alcohol consumption are clear and 
    substantial and have far-reaching health and social consequences. 
    Alcohol is the second leading cause of preventable deaths in the 
    United States as well as most industrialized countries, second only 
    to cigarette smoking. Drinking increases the risk of cancer of the 
    liver, mouth, tongue, and esophagus and has been implicated as a 
    cause of 3 to 5 percent of all cancer deaths. Heavy alcohol 
    consumption is also associated with increased risks of hemorrhagic 
    stroke and cardiomyopathy, and it predisposes to hepatic cirrhosis, 
    the ninth most common cause of death in the United States. In 
    pregnant women, heavy alcohol consumption is associated with fetal 
    alcohol syndrome. Alcohol drinking is also implicated in over 40 
    percent of all fatal traffic crashes, which are a chief cause of 
    premature deaths in younger people, and it is associated with 
    suicides, industrial accidents, sex crimes, robberies, and murders. 
    It is estimated that 14 million U.S.
    
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    residents suffer from alcohol abuse and dependence, and 76 million 
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    are affected by its presence in a family member.
    
        It is true that many of these health risks are caused by heavy 
    levels of alcohol consumption. It is also true that there are millions 
    of Americans with alcohol dependency problems who find themselves 
    unable or unwilling to control their consumption of alcohol. Given the 
    serious health risks associated with higher levels of alcohol 
    consumption, and given the fact that most medical studies agree that 
    the effects of moderate consumption differ from individual to 
    individual, any claim associating health benefits with moderate alcohol 
    consumption must be carefully evaluated to ensure that it does not 
    mislead the consumer about the various health consequences related to 
    the consumption of alcohol beverages.
        We recognize that there are several scientific studies suggesting a 
    link between moderate alcohol consumption and a lower risk of coronary 
    artery disease (``CAD'').\2\ However, at this time, we do not believe 
    there is significant scientific evidence to support an unqualified 
    conclusion that moderate wine (alcohol) consumption has health benefits 
    for all or even most individual consumers. Some studies have suggested 
    that only older drinkers will accrue any health benefits from moderate 
    alcohol consumption.\3\ This is because younger individuals have such a 
    low risk for coronary artery disease and are much more likely to be at 
    risk from alcohol consumption even at lower levels. This difference in 
    risk factors has been explained as follows: \4\
    
        The net contents of all-cause mortality associated with a 
    certain alcohol consumption level therefore also depends on the 
    drinker's absolute risk of dying from these various causes. 
    Accordingly, older people--who are at high absolute risk of coronary 
    heart disease and ischemic stroke and at low risk for injury, 
    cirrhosis, and other alcohol-related diseases--are most likely to 
    benefit from low levels of alcohol consumption. In contrast, for men 
    and women under age 40, who have relatively low absolute risk of 
    dying from strokes, heart disease, and alcohol-related diseases but 
    a high absolute risk of dying from injury, all-cause mortality will 
    increase even at relatively low alcohol-consumption rates * * *. 
    Finally, the absolute risk of death from injury or coronary heart 
    disease is lower in young women than in young men, leading to an 
    increase in all-cause mortality even in young women who are light 
    drinkers (less than two drinks every 3 days) compared with 
    abstainers.
    
        Overall, the available scientific literature suggests that there 
    may be serious health risks associated with heavy as well as moderate 
    alcohol consumption, depending on the individual.\5\ In light of the 
    negative health consequences of alcohol consumption or abuse, it is 
    possible that these products may not be entitled to any health-related 
    statement. As noted below in section VII, the Federal Trade Commission 
    has adopted a policy that unqualified health claims on products that 
    pose increased health risks are deceptive. Accordingly, we are 
    soliciting comments on whether alcohol beverages should not be entitled 
    to health-related statements.
    
    IV. Industry Circular 93-8
    
        On August 2, 1993, we published Industry Circular 93-8. The 
    circular generally restated our existing position regarding misleading 
    curative and therapeutic claims, i.e., we view statements that make 
    substantive claims regarding health benefits associated with alcohol 
    beverage consumption as making therapeutic or curative claims. Any 
    claim that sets forth only a partial picture or representation might be 
    as likely to mislead the consumer as those that are actually false. 
    Thus, a statement which attributes health benefits to the moderate 
    consumption of alcohol beverages, even if supported by medical 
    evidence, might have an overall misleading effect if such statement is 
    not properly qualified, does not give all sides of the issue, and does 
    not outline the categories of individuals for whom any such positive 
    effect would be outweighed by numerous negative health effects.
        We also explained that our existing policy regarding health claims 
    on labels had been reinforced by the 1988 enactment of the Alcoholic 
    Beverage Labeling Act (ABLA), 27 U.S.C. 213 et seq. The ABLA contains a 
    declaration of policy and purpose that states that the Congress finds 
    that ``the American public should be informed about the health hazards 
    that may result from the consumption or abuse of alcoholic beverages, 
    and has determined that it would be beneficial to provide a clear, 
    nonconfusing reminder of such hazards, and that there is a need for 
    national uniformity in such reminders in order to avoid the 
    promulgation of incorrect or misleading information and to minimize 
    burdens on interstate commerce.'' 27 U.S.C. 213. As a result of this 
    concern, the ABLA requires that any alcohol beverage container held for 
    sale or distribution in the United States must bear the following 
    statement on the label:
    
        GOVERNMENT WARNING: (1) According to the Surgeon General, women 
    should not drink alcoholic beverages during pregnancy because of the 
    risk of birth defects. (2) Consumption of alcoholic beverages 
    impairs your ability to drive a car or operate machinery, and may 
    cause health problems.
    
        It is clear that one of the purposes of the ABLA was to avoid 
    confusing the American public about the health hazards associated with 
    the consumption of alcohol beverages. In order to accomplish this goal, 
    Congress prescribed specific language that must appear on the labels of 
    alcohol beverage products. It is our position that to the extent that 
    the overall message of any health claim is inconsistent with the 
    message of the health warning statement, it may result in label 
    information that is misleading and confusing to the consumer and would 
    be prohibited under the FAA Act.
        In Industry Circular 93-8, we further noted that other Federal 
    agencies, such as the Food and Drug Administration and the Federal 
    Trade Commission, may have jurisdiction over certain aspects of 
    labeling and advertising issues involving health claims. We will 
    address this issue further in section VII (Role of Other Federal 
    Agencies With Respect to Health Claims and Other Health-Related 
    Statements).
        We also stated that the distribution of advertising materials which 
    included the full text of the April 1992 edition of ``Alcohol Alert,'' 
    published by the National Institute on Alcohol Abuse and Alcoholism 
    (NIAAA), would not be in violation of current regulations. This NIAAA 
    publication provides a comprehensive discussion of the health 
    consequences of moderate alcohol consumption. If such advertising 
    materials also contain editorializing, advertising slogans, or 
    exhortations to consume the product, we would evaluate such additional 
    text to determine whether or not the advertisement presents a balanced 
    picture of the risks associated with alcohol consumption. In addition, 
    we stated that the use of buttons, shelf talkers, table tents, and 
    similar items that excerpt any portion of the NIAAA publication, that 
    contain health slogans or other inferential statements drawn from this 
    publication, or that are based upon any other publication or article 
    citing the health benefits of alcohol consumption, will be closely 
    scrutinized to determine if they present a balanced picture of the 
    risks associated with alcohol consumption.
        In addition, we reminded industry members in Industry Circular 93-8 
    that substantive health claims on labels are considered to be 
    misleading unless they are properly qualified, present all sides of the 
    issue, and outline the categories of individuals for whom any positive 
    effects would be outweighed by
    
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    numerous negative health effects. We concluded that it would be 
    extremely unlikely that any such balanced claim would fit on a normal 
    alcohol beverage label. Our policy with respect to substantive health 
    claims has not changed since the issuance of the industry circular. 
    Finally, we stated that it was our intent to initiate rulemaking on 
    this issue; however, pending rulemaking, we would continue to evaluate 
    claims in labeling and advertising on a case-by-case basis.
    
    V. Competitive Enterprise Institute Petition
    
        On May 9, 1995, the Competitive Enterprise Institute (CEI) 
    submitted a petition asking us to issue a rule allowing alcohol 
    beverage labels and advertisements to carry statements regarding the 
    purported benefits of moderate alcohol consumption of alcohol 
    beverages. More specifically, CEI proposed that the following language 
    be permitted on labels and in advertisements: ``There is significant 
    evidence that moderate consumption of alcoholic beverages may reduce 
    the risk of heart disease.'' We would consider this statement to be an 
    example of a substantive health claim. By letter dated January 13, 
    1997, we denied this rulemaking petition stating that the specific 
    health claim proposed by CEI was not appropriately qualified, was not 
    balanced regarding the health consequences of alcohol consumption and, 
    as such, its use on labels could mislead consumers.
    
    VI. Dietary Guidelines
    
        The Fourth Edition (1995) of the ``Dietary Guidelines for 
    Americans'' was published by the U.S. Department of Agriculture and the 
    U.S. Department of Health and Human Services in 1996. The Guidelines 
    contain a detailed discussion concerning the consequences and effects 
    of alcohol beverage consumption. There have been suggestions that the 
    Federal government itself, in its issuance of the Dietary Guidelines, 
    has officially recognized the health benefits of moderate alcohol 
    consumption. It is true that the Guidelines acknowledge that 
    ``[c]urrent evidence suggests that moderate drinking is associated with 
    a lower risk for coronary heart disease in some individuals.'' However, 
    this is not a statement of a health benefit; it is merely a conclusion 
    that in some individuals, moderate drinking may be associated with a 
    lower risk of coronary heart disease. The Dietary Guidelines then go on 
    to discuss the ``serious health problems'' caused by alcohol 
    consumption as follows:
    
        However, higher levels of alcohol intake raise the risk for high 
    blood pressure, stroke, heart disease, certain cancers, accidents, 
    violence, suicides, birth defects, and overall mortality (deaths). 
    Too much alcohol may cause cirrhosis of the liver, inflammation of 
    the pancreas, and damage to the brain and heart. Heavy drinkers also 
    are at risk of malnutrition because alcohol contains calories that 
    may substitute for those in more nutritious foods.
    
        The Dietary Guidelines recommend that if adults choose to drink 
    alcohol beverages, they should consume them only in moderation. The 
    term ``moderation'' is defined as no more than one drink per day for 
    women and no more than two drinks per day for men. However, the Dietary 
    Guidelines also conclude that for some people, even moderate drinking 
    is not recommended. Thus, many people should not drink alcohol 
    beverages at all, including children and adolescents, women who are 
    trying to conceive or who are pregnant, individuals who plan to drive 
    or take part in activities that require attention or skill, and 
    individuals using prescription and over-the-counter medications. 
    Finally, the Dietary Guidelines also suggest that individuals of any 
    age who cannot restrict their drinking to moderate levels should not 
    drink at all. This last category is obviously hard to define, and may 
    include many individuals who do not even realize that they fall within 
    this category.
        It is clear that the Dietary Guidelines explicitly recognize that 
    moderate alcohol consumption is not an activity that has only 
    beneficial effects to the health of the consumer. Millions of adult 
    consumers fall within the categories of people who should not drink 
    alcohol beverages at all. The Dietary Guidelines do not represent an 
    unqualified endorsement of the health benefits of moderate alcohol 
    consumption. Thus, without appropriate qualifications and explanations, 
    any such statement to that effect would tend to mislead consumers. 
    However, we have no objections to the dissemination of the entire 
    Dietary Guidelines as advertising materials by industry members or to 
    the dissemination of the two pages from the Guidelines dealing with 
    alcohol beverages (pages 40 and 41).
    
    VII. Role of Other Federal Agencies With Respect to Health Claims 
    and Other Health-Related Statements
    
        While ATF has primary jurisdiction over the labeling and 
    advertising of alcohol beverages, under certain circumstances the 
    labeling and advertising of alcohol beverages may also be subject to 
    the jurisdiction of the Food and Drug Administration (FDA) or the 
    Federal Trade Commission (FTC). For example, since certain wine 
    products containing less than 7 percent alcohol by volume are not wines 
    subject to the FAA Act, the labeling of such products falls within 
    FDA's jurisdiction. We have always utilized the scientific and public 
    health expertise of FDA in approving ingredients in alcohol beverages, 
    requiring label disclosure of certain substances, and identifying 
    adulterated alcohol beverages that are deemed mislabeled.
        FDA has advised us that certain curative, therapeutic, or disease-
    prevention claims for an alcohol beverage might place the product in 
    the category of a drug under the Federal Food, Drug, and Cosmetic Act 
    (FFD&C Act), 21 U.S.C. 321(g)(1)(B). FDA evaluates health claims on 
    food labels pursuant to its authority under the FFD&C Act, as amended 
    by the Nutrition Labeling and Education Act (NLEA), Public Law 101-535 
    (1990). The law provides that a food product is misbranded if it bears 
    a claim that characterizes the relationship of a nutrient to a disease 
    or health-related condition, unless the claim is made in accordance 
    with certain procedures mandated by the FDA. See 21 U.S.C. 
    343(r)(1)(B). FDA's regulations provide that FDA will only approve a 
    health claim when it determines, ``based on the totality of publicly 
    available scientific evidence'' that there is ``significant scientific 
    agreement, among experts qualified by scientific training and 
    experience to evaluate such claims, that the claim is supported by such 
    evidence.'' 21 CFR 101.14(c). ATF would continue to review health-
    related statements to ensure consistency with FDA's statutory and 
    regulatory authorities.
        The FTC's general jurisdiction over advertising extends to alcohol 
    beverages. A problem that is of particular relevance to the area of 
    alcohol beverage advertising is that of the ``qualified'' health claim. 
    In their policy statement, published in the Federal Register on June 1, 
    1994 (59 FR 28394), the FTC stated that it is necessary to examine 
    ``whether qualified claims are presented in a manner that ensures that 
    consumers understand both the extent of the support for the claim and 
    the existence of any significant contrary view within the scientific 
    community.'' We would also note that the FTC policy statement stated 
    that an unqualified health claim in the advertising of a food was 
    likely to be deceptive if the food also contained a nutrient that 
    increased the
    
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    risk for another disease or health-related condition, and the risk-
    increasing nutrient was closely related to the subject health claim.
    
    VIII. Notice of Proposed Rulemaking
    
        We are proposing to revise the regulations to reflect our current 
    policy and to provide that labels or advertisements may not contain any 
    statement, design, representation, pictorial representation, or device, 
    whether explicit or implicit, representing that consumption of alcohol 
    beverages has curative or therapeutic effects if such statement is 
    untrue in any particular or tends to create a misleading impression. A 
    substantive claim regarding health benefits associated with the use of 
    an alcohol beverage is misleading unless such claim is properly 
    qualified, balanced, sufficiently detailed and specific, and outlines 
    the categories of individuals for whom any positive health effects 
    would be outweighed by numerous negative health effects.
        While industry members are not required to submit advertising 
    materials to us for pre-approval, we encourage the use of our voluntary 
    pre-clearance process for any advertisements that refer to the health 
    effects of alcohol consumption.
        We believe that the proposed regulations will ensure that labels 
    and advertisements do not contain statements or claims that would tend 
    to mislead the consumer about the significant health consequences of 
    alcohol consumption.
    
    IX. First Amendment Issues
    
        Various members of the alcohol beverage industry have suggested 
    that under the First Amendment to the United States Constitution, ATF 
    is precluded from preventing the dissemination of truthful information 
    about health benefits from alcohol beverage labels and advertisements. 
    We are prohibiting the use of misleading statements regarding health 
    claims that are by definition not protected by the First Amendment. 
    Commercial speech is protected by the First Amendment only if it is 
    truthful and not misleading. Central Hudson Gas & Elec. Corp. v. Public 
    Serv. Comm'n of New York, 447 U.S. 557, 566 (1980). This longstanding 
    position has been upheld by the Supreme Court in its most recent 
    commercial speech decision. See 44 Liquor Mart, Inc. v. Rhode Island, 
    1996 U.S. LEXIS 3020 (1996).
    
    X. Footnotes Appearing in Text of Supplementary Information
    
        1. Hennekens, C.H., ``Alcohol and Risk of Coronary Events,'' 
    Research Monograph No. 31, ``Alcohol and the Cardiovascular System'' 
    at 15 (National Institutes of Health, National Institute on Alcohol 
    Abuse and Alcoholism, Bethesda, MD, 1996).
        2. See, e.g., Boffetta, P. & Garfinkel, L., ``Alcohol drinking 
    and mortality among men enrolled in an American Cancer Society 
    prospective study, ``Epidemiology'' 1(5):343-348, 1990; Stampfer, 
    M.J.; Colditz, G.A.; Willett, W.C.; Speizer, F.E. & Hennekens, C.H., 
    ``A prospective study of moderate alcohol consumption and the risk 
    of coronary disease and stroke in women,'' ``New England Journal of 
    Medicine,'' 319(5):267-273, 1988; Klatsky, A.L.; Armstrong, M.A.; 
    and Friedman, G.D., ``Alcohol and Mortality,'' ``Annals of Internal 
    Medicine,'' 117:646-654, 1992. See generally National Institute on 
    Alcohol Abuse and Alcoholism, ``Moderate Drinking,'' ``Alcohol 
    Alert,'' No. 16, April 1992, at 2, and studies cited therein.
        3. See, e.g., Criqui, M.H., ``Moderate Drinking: Benefits and 
    Risks,'' ``Alcohol and the Cardiovascular System,'' at 117-118 
    (``Clearly, younger persons cannot possibly benefit much from 
    alcohol consumption, at least in the short term, because their risk 
    of ischemic CVD events is so low.'').
        4. DuFour, M.C., ``Risks and Benefits of Alcohol Use Over the 
    Life Span,'' ``Alcohol Health & Research World,'' Vol. 20, No. 
    3:145-150 at 147, 1996.
        5. See, e.g., Hennekens, C.H., ``Alcohol and risk of coronary 
    events,'' Research Monograph No. 31, ``Alcohol and the 
    Cardiovascular System'' at 20 (National Institutes of Health, 
    National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 
    1996) (``while the health risks of excessive drinking are clear, 
    there may also be hazards associated with moderate intake that must 
    be weighed, on an individual basis, against the apparent protection 
    against CHD.'').
    
    How This Document Complies With the Federal Administrative 
    Requirements for Rulemaking
    
    A. Executive Order 12866
    
        We have determined that this proposed rule is not a significant 
    regulatory action as defined in E.O. 12866. Therefore, a Regulatory 
    Assessment is not required.
    
    B. Regulatory Flexibility Act
    
        The Regulatory Flexibility Act (RFA) generally requires an agency 
    to conduct a regulatory flexibility analysis of any rule subject to 
    notice and comment rulemaking requirements unless the agency certifies 
    that the rule will not have a significant economic impact on a 
    substantial number of small entities. Small entities include small 
    businesses, small not-for-profit enterprises, and small governmental 
    jurisdictions. We have determined that this proposed rule will not have 
    a significant economic impact on a substantial number of small 
    entities. The proposed regulations merely clarify ATF's existing policy 
    concerning the use of health claims in the labeling and advertising of 
    alcohol beverages and impose no burdens on the industry. Accordingly, a 
    regulatory flexibility analysis is not required.
    
    C. Paperwork Reduction Act
    
        The provisions of the Paperwork Reduction Act of 1995, Public Law 
    104-13, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR 
    part 1320, do not apply to this notice of proposed rulemaking because 
    no requirement to collect information is imposed.
    
    Public Participation
    
        We are requesting comments on the proposed regulations from all 
    interested persons. In particular, we are asking for public comment on 
    our existing policy relating to health claims and other health-related 
    statements on alcohol beverage labels and in advertisements (see 
    section II). We also ask whether health-related statements on alcohol 
    beverage labels and advertising directing consumers to balanced sources 
    of information are misleading and whether ATF should continue to 
    approve such statements. We are also asking whether the negative health 
    consequences of alcohol consumption or abuse disqualify, as misleading, 
    these products entirely from entitlement to any health-related 
    statements (see section III). In addition, we are specifically 
    requesting comments on the clarity of this proposed rule and how it may 
    be made easier to understand.
        Comments received on or before the closing date will be carefully 
    considered. Comments received after that date will be given the same 
    consideration if it is practical to do so, but assurance of 
    consideration cannot be given except as to comments received on or 
    before the closing date.
        ATF will not recognize any material in comments as confidential. 
    Comments may be disclosed to the public. Any material that the 
    commenter considers to be confidential or inappropriate for disclosure 
    to the public should not be included in the comment. The name of the 
    person submitting a comment is not exempt from disclosure.
        Any interested person who desires an opportunity to comment orally 
    at a public hearing should submit his or her request, in writing, to 
    the Director within the 120-day comment period. The Director, however, 
    reserves the right to determine, in light of all
    
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    circumstances, whether a public hearing is necessary.
    
    Disclosure
    
        Copies of this notice and the comments received will be available 
    for public inspection during normal business hours at: ATF Public 
    Reading Room, Room 6480, 650 Massachusetts Avenue, NW, Washington, DC.
    
    Drafting Information
    
        The author of this document is James P. Ficaretta, Regulations 
    Division, Bureau of Alcohol, Tobacco and Firearms.
    
    List of Subjects
    
    27 CFR Part 4
    
        Advertising, Consumer protection, Customs duties and inspection, 
    Imports, Labeling, Packaging and containers, and Wine.
    
    27 CFR Part 5
    
        Advertising, Consumer protection, Customs duties and inspection, 
    Imports, Labeling, Liquors, and Packaging and containers.
    
    27 CFR Part 7
    
        Advertising, Consumer protection, Customs duties and inspection, 
    Imports, and Labeling.
    
    Authority and Issuance
    
        For the reasons discussed in the preamble, ATF amends 27 CFR parts 
    4, 5, and 7 as follows:
    
    PART 4--LABELING AND ADVERTISING OF WINE
    
        Paragraph 1. The authority citation for 27 CFR part 4 continues to 
    read as follows:
    
        Authority: 27 U.S.C. 205.
    
        Par. 2. Section 4.39(h) is revised to read as follows:
    
    
    Sec. 4.39  Prohibited practices.
    
    * * * * *
        (h) Curative and therapeutic claims. Labels may not contain any 
    statement, design, representation, pictorial representation, or device, 
    whether explicit or implicit, that represents that the use of wine has 
    curative or therapeutic effects if such statement is untrue in any 
    particular or tends to create a misleading impression. A substantive 
    claim regarding health benefits associated with the use of wine is 
    misleading unless such claim is properly qualified, balanced, 
    sufficiently detailed and specific, and outlines the categories of 
    individuals for whom any positive health effects would be outweighed by 
    numerous negative health effects.
    * * * * *
        Par. 3. Section 4.64(i) is revised to read as follows:
    
    
    Sec. 4.64  Prohibited practices.
    
    * * * * *
        (i) Curative and therapeutic claims. Advertisements may not contain 
    any statement, design, representation, pictorial representation, or 
    device, whether explicit or implicit, that represents that the use of 
    wine has curative or therapeutic effects if such statement is untrue in 
    any particular or tends to create a misleading impression. A 
    substantive claim regarding health benefits associated with the use of 
    wine is misleading unless such claim is properly qualified, balanced, 
    sufficiently detailed and specific, and outlines the categories of 
    individuals for whom any positive health effects would be outweighed by 
    numerous negative health effects.
    * * * * *
    
    PART 5--LABELING AND ADVERTISING OF DISTILLED SPIRITS
    
        Par. 4. The authority citation for 27 CFR part 5 continues to read 
    as follows:
    
        Authority: 26 U.S.C. 5301, 7805; 27 U.S.C. 205.
    
    Par. 5. Section 5.42(b)(8) is revised to read as follows:
    
    
    Sec. 5.42  Prohibited practices.
    
    * * * * *
        (b) * * *
        (8) Curative and therapeutic claims. Labels may not contain any 
    statement, design, representation, pictorial representation, or device, 
    whether explicit or implicit, that represents that the use of distilled 
    spirits has curative or therapeutic effects if such statement is untrue 
    in any particular or tends to create a misleading impression. A 
    substantive claim regarding health benefits associated with the use of 
    distilled spirits is misleading unless such claim is properly 
    qualified, balanced, sufficiently detailed and specific, and outlines 
    the categories of individuals for whom any positive health effects 
    would be outweighed by numerous negative health effects.
        Par. 6. Section 5.65(d) is revised to read as follows:
    
    
    Sec. 5.65  Prohibited practices.
    
    * * * * *
        (d) Curative and therapeutic claims. Advertisements may not contain 
    any statement, design, representation, pictorial representation, or 
    device, whether explicit or implicit, that represents that the use of 
    distilled spirits has curative or therapeutic effects if such statement 
    is untrue in any particular, or tends to create a misleading 
    impression. A substantive claim regarding health benefits associated 
    with the use of distilled spirits is misleading unless such claim is 
    properly qualified, balanced, sufficiently detailed and specific, and 
    outlines the categories of individuals for whom any positive health 
    effects would be outweighed by numerous negative health effects.
    * * * * *
    
    PART 7--LABELING AND ADVERTISING OF MALT BEVERAGES
    
        Par. 7. The authority citation for 27 CFR part 7 continues to read 
    as follows:
    
        Authority: 27 U.S.C. 205.
    
        Par. 8. Section 7.29(e) is revised to read as follows:
    
    
    Sec. 7.29  Prohibited practices.
    
    * * * * *
        (e) Curative and therapeutic claims. Labels may not contain any 
    statement, design, representation, pictorial representation, or device, 
    whether explicit or implicit, that represents that the use of malt 
    beverages has curative or therapeutic effects if such statement is 
    untrue in any particular or tends to create a misleading impression. A 
    substantive claim regarding the health benefits associated with the use 
    of malt beverages is misleading unless such claim is properly 
    qualified, balanced, sufficiently detailed and specific, and outlines 
    the categories of individuals for whom any positive health effects 
    would be outweighed by numerous negative health effects.
    * * * * *
        Par. 9. Section 7.54(e) is revised to read as follows:
    
    
    Sec. 7.54  Prohibited practices.
    
    * * * * *
        (e) Curative and therapeutic claims. Advertisements may not contain 
    any statement, design, representation, pictorial representation, or 
    device, whether explicit or implicit, that represents that the use of 
    malt beverages has curative or therapeutic effects if such statement is 
    untrue in any particular or tends to create a misleading impression. A 
    substantive claim regarding health benefits associated with the use of 
    malt beverages is misleading unless such claim is properly qualified, 
    balanced, sufficiently detailed and specific, and outlines the 
    categories of individuals for whom any positive health effects would
    
    [[Page 57418]]
    
    be outweighed by numerous negative health effects.
    * * * * *
        Signed: October 19, 1999.
    John W. Magaw,
    Director.
    
        Approved: October 20, 1999.
    John P. Simpson,
    Deputy Assistant Secretary (Regulatory, Tariff and Trade Enforcement).
    [FR Doc. 99-27774 Filed 10-20-99; 3:28 pm]
    BILLING CODE 4810-31-P
    
    
    

Document Information

Published:
10/25/1999
Department:
Alcohol, Tobacco, Firearms, and Explosives Bureau
Entry Type:
Proposed Rule
Action:
Notice of proposed rulemaking.
Document Number:
99-27774
Dates:
Comments must be received on or before February 22, 2000.
Pages:
57413-57418 (6 pages)
Docket Numbers:
Notice No. 884
RINs:
1512-AB97: Health Claims and Other Health Related Statements in the Labeling and Advertising of Alcohol Beverages
RIN Links:
https://www.federalregister.gov/regulations/1512-AB97/health-claims-and-other-health-related-statements-in-the-labeling-and-advertising-of-alcohol-beverag
PDF File:
99-27774.pdf
CFR: (6)
27 CFR 4.39
27 CFR 4.64
27 CFR 5.42
27 CFR 5.65
27 CFR 7.29
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