Monday, March 3, 2003

Part II

Department of Treasury Alcohol and Tobacco and Trade Bureau

27 CFR Parts 4, 5, and 7 Health Claims and Other Health-Related Statements in the Labeling and Advertising of Alcohol Beverages (99R– 199P); Final Rule

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DEPARTMENT OF THE TREASURY that labels and advertisements do not Authority and Issuance contain statements or claims that would I. Background Alcohol and Tobacco Tax and Trade tend to mislead the consumer about the Bureau significant health consequences of The Federal Alcohol Administration alcohol consumption. Act (FAA Act), 27 U.S.C. 205(e) and (f), authorizes TTB to issue regulations on 27 CFR Parts 4, 5, and 7 DATES: This rule is effective June 2, 2003. the packaging, labeling and advertising [TTB T.D.–1; Ref: ATF Notice Nos. 884, 892, of alcohol beverages in order to prohibit and 896] FOR FURTHER INFORMATION CONTACT: deception of the consumer, and to RIN: 1512–AB97 William H. Foster, Regulations and prohibit, irrespective of falsity, Procedures Division, Alcohol and statements relating to analyses, Health Claims and Other Health- Tobacco Tax and Trade Bureau, 650 guarantees, and scientific or irrelevant Related Statements in the Labeling and Massachusetts Avenue, NW., matters that are likely to mislead the Advertising of Alcohol Beverages Washington, DC 20226 (202–927–8210). consumer. The FAA Act generally (99R–199P) SUPPLEMENTARY INFORMATION: Please requires bottlers and importers of note: References to ‘‘ATF’’ are to the alcohol beverages to obtain certificates AGENCY: Alcohol and Tobacco Tax and Bureau of Alcohol, Tobacco and of label approval prior to the bottling or Trade Bureau (TTB), Treasury. Firearms as it existed before January 24, importation of alcohol beverages for sale ACTION: Final rule, Treasury decision. 2003. The new Alcohol and Tobacco in interstate commerce. Pre-approval of Tax and Trade Bureau (TTB) has taken advertising is not required by the FAA SUMMARY: TTB is amending the over the former ATF’s responsibilities Act. regulations to prohibit the appearance for alcohol beverage labeling Regulations that implement the on labels or in advertisements of any regulations. provisions of section 205(e) and (f), as health-related statement, including a they relate to the labeling and specific health claim, that is untrue in Table of Contents advertising of wine, distilled spirits, and any particular or tends to create a I. Background malt beverages, are set forth in Title 27, misleading impression. A specific II. Health Consequences of Alcohol Code of Federal Regulations (CFR), parts health claim on a label or in an Consumption 4, 5, and 7, respectively. These current advertisement is considered misleading III. Industry Circular 93–8 IV. Role of Other Federal Agencies With regulations prohibit the appearance on unless the claim is truthful and Respect to Specific Health Claims and labels or in advertisements of any adequately substantiated by scientific Other Health-Related Statements statement, design, representation, evidence; properly detailed and V. Fourth Edition of the Dietary Guidelines pictorial representation, or device qualified with respect to the categories for Americans (1995) representing that the use of wine, of individuals to whom the claim VI. Competitive Enterprise Institute Petition distilled spirits, or malt beverages has applies; adequately discloses the health VII. Other Health-Related Statements on curative or therapeutic effects if the risks associated with both moderate and Alcohol Beverage Labels representation is untrue in any heavier levels of alcohol consumption; VIII. Notice of Proposed Rulemaking IX. Notice of Hearings particular or tends to create a and outlines the categories of X. Recent Developments misleading impression. This standard individuals for whom any levels of XI. Analysis of Comments Received in originated more than 60 years ago with alcohol consumption may cause health Response to Notice No. 884 the initial labeling and advertising risks. In addition, TTB will consult with XII. Is There a Need To Engage in regulations issued under the FAA Act. the Food and Drug Administration Rulemaking on This Issue? TTB and its predecessor agencies (FDA), as needed, on the use of specific XIII. Does the ABLA Preclude the Use of have historically taken a very strict view health claims on labels. If FDA Specific Health Claims or Other Health- of the regulatory prohibition on false or determines that a specific health claim Related Statements on the Labels of misleading curative or therapeutic is a drug claim that is not in compliance Alcohol Beverages? XIV. What Are the Effects on Health of claims about alcohol beverages. This with the requirements of the Federal Alcohol Consumption? strict interpretation is based on the view Food, Drug, and Cosmetic Act, TTB will XV. Are Health Claims and Health-Related that ‘‘distilled spirits, wines and malt not approve the use of such statement Statements in the Labeling and Advertising beverages are, in reality, alcoholic on a label. of Alcohol Beverages Inherently beverages and not medicines of any sort, Health-related statements that are not Misleading? * * *.’’ FA–129, dated January 5, 1938. specific health claims or health-related XVI. Are Health-Related Directional In view of the undisputed health risks directional statements will be evaluated Statements Misleading? associated with alcohol consumption, on a case-by-case basis to determine if XVII. Should the Same Standards Apply to we and our predecessors have always they tend to mislead consumers. The Wines, Distilled Spirits, and Malt taken the position that statements Beverages? final rule provides that health-related XVIII. Should TTB Adopt the Procedures Set attributing positive effects on health to directional statements (statements that Forth in FDA’s Regulations? the consumption of alcohol beverages direct or refer consumers to a third party XIX. Is the Final Rule Consistent With the are misleading unless such statements or other source for information First Amendment? are appropriately qualified and properly regarding the effects on health of XX. Final Rule balanced. TTB views statements that alcohol consumption) will be presumed XXI. Applications for and Certificates of make substantive claims regarding misleading unless those statements Label Approval health benefits associated with alcohol include a brief disclaimer advising XXII. Notes Appearing in Text of beverage consumption (e.g., ‘‘moderate consumers that the statement should not Supplementary Information alcohol consumption is good for your XXIII. How This Document Complies With encourage consumption of alcohol for the Federal Administrative health’’) as making curative or health reasons, or some other Requirements for Rulemaking therapeutic claims. Claims that set forth appropriate disclaimer to avoid Disclosure only a partial picture or representation misleading consumers. TTB believes Drafting Information might be as likely to mislead the that the final regulations will ensure List of Subjects consumer as those that are actually

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false. A claim that is supported by between moderate alcohol consumption ATF also explained that its policy scientific evidence might still mislead and a reduced risk of coronary artery regarding health claims on labels had the consumer without appropriate disease (‘‘CAD’’).2 However, it was been reinforced by the 1988 enactment qualification and detail. Any such claim ATF’s conclusion that there was not of the Alcoholic Beverage Labeling Act is considered misleading unless it is significant scientific evidence to (ABLA), 27 U.S.C. 213 et seq. The ABLA properly qualified and balanced, support an unqualified conclusion that contains a declaration of policy and sufficiently detailed and specific, and moderate alcohol consumption has net purpose which states that the Congress outlines the categories of individuals for health benefits for all or even most finds that ‘‘the American public should whom any positive effects on health individual consumers. Some studies be informed about the health hazards would be outweighed by numerous have suggested that only older drinkers that may result from the consumption or negative effects on health. will accrue any net health benefits from abuse of alcoholic beverages, and has moderate alcohol consumption.3 This is determined that it would be beneficial II. Health Consequences of Alcohol because younger individuals have such to provide a clear, nonconfusing Consumption a low risk for coronary artery disease, reminder of such hazards, and that there The risks associated with alcohol and are much more likely to be at risk is a need for national uniformity in such consumption are well documented. In from alcohol consumption, even at reminders in order to avoid the Notice No. 884, ATF summarized these lower levels. This difference in risk promulgation of incorrect or misleading risks as set forth in an article by Charles factors has been explained as follows:4 information and to minimize burdens H. Hennekens, M.D. as follows: 1 on interstate commerce.’’ 27 U.S.C. 213. The net outcome of all-cause mortality The hazards of heavy alcohol consumption associated with a certain alcohol As a result of this concern, the ABLA are clear and substantial and have far- consumption level therefore also depends on requires that any alcohol beverage reaching health and social consequences. the drinker’s absolute risk of dying from container held for sale or distribution in Alcohol is the second leading cause of these various causes. Accordingly, older the United States must bear the preventable deaths in the United States as people—who are at high absolute risk of following statement on the label: well as most industrialized countries, second coronary heart disease and ischemic stroke Government Warning: (1) According to the only to cigarette smoking. Drinking increases and at low risk for injury, cirrhosis, and other the risk of cancer of the liver, mouth, tongue, Surgeon General, women should not drink alcohol-related diseases’are most likely to alcoholic beverages during pregnancy and esophagus and has been implicated as a benefit from low levels of alcohol cause of 3 to 5 percent of all cancer deaths. because of the risk of birth defects. (2) consumption. In contrast, for men and Consumption of alcoholic beverages impairs Heavy alcohol consumption is also women under age 40, who have relatively associated with increased risks of your ability to drive a car or operate low absolute risk of dying from strokes, heart machinery, and may cause health problems. hemorrhagic stroke and cardiomyopathy, and disease, and alcohol-related diseases but a it predisposes to hepatic cirrhosis, the ninth high absolute risk of dying from injury, all- It is clear that one of the purposes of most common cause of death in the United cause mortality will increase even at the ABLA was to avoid confusing the States. In pregnant women, heavy alcohol relatively low alcohol-consumption levels. American public about the health consumption is associated with fetal alcohol * * *. Finally, the absolute risk of death hazards associated with the syndrome. Alcohol drinking is also from injury or coronary heart disease is lower implicated in over 40 percent of all fatal consumption of alcohol beverages. In in young women than in young men, leading traffic crashes, which are a chief cause of order to effectuate this goal, Congress to an increase in all-cause mortality even in premature deaths in younger people, and it prescribed specific language that must young women who are light drinkers (less is associated with suicides, industrial appear on the labels of alcohol beverage than two drinks every 3 days) compared with accidents, sex crimes, robberies, and containers. To the extent that the overall abstainers. (Citations omitted). murders. It is estimated that 14 million U.S. message of any health claim is residents suffer from alcohol abuse and Overall, the available scientific inconsistent with the message of the dependence, and 76 million are affected by literature establishes that there may be Government warning statement, then it its presence in a family member. (Citations serious health risks associated with may result in label information that is omitted). heavy as well as moderate alcohol confusing and could mislead the It is true that heavier levels of alcohol consumption, depending on the consumer, and would thus be consumption cause many of these individual.5 prohibited under the FAA Act. health risks. It is also true that there are III. Industry Circular 93–8 In Industry Circular 93–8, ATF further millions of Americans with alcohol noted that other Federal agencies, such dependency problems who find On August 2, 1993, ATF published as the Food and Drug Administration themselves unable or unwilling to Industry Circular 93–8. The circular and the Federal Trade Commission, control their consumption of alcohol. generally restated ATF’s longstanding might have jurisdiction over certain Given the serious health risks associated position regarding misleading curative aspects of advertising and labeling with higher levels of alcohol and therapeutic claims. ATF explained issues involving health claims. We will consumption, and given the fact that that claims that set forth only a partial address this issue further in section IV most medical studies agree that the picture, representation, or truth might (‘‘Role of Other Federal Agencies with effects of moderate consumption differ be as likely to mislead the consumer as Respect to Specific Health Claims and from individual to individual, it was those that are actually false. Thus, a other Health-Related Statements’’). ATF’s longstanding, and is now our, statement that attributed health benefits ATF also stated that the distribution position that any claim associating to the moderate consumption of alcohol of advertising materials that included health benefits with moderate alcohol beverages, even if backed up by medical the full text of the April 1992 edition of consumption must be carefully evidence, might have an overall ‘‘Alcohol Alert,’’ a publication of the evaluated to ensure that it does not misleading effect if such statement was National Institute on Alcohol Abuse and mislead the consumer about the various not properly qualified, did not give all Alcoholism (NIAAA), would not be in health consequences related to the sides of the issue, and did not outline violation of current regulations. This consumption of alcohol beverages. the categories of individuals for whom NIAAA publication provides a Prior to engaging in this rulemaking, any such positive effect would be comprehensive discussion of the health ATF recognized that there were several outweighed by numerous negative consequences of moderate alcohol scientific studies establishing a link effects on health. consumption. The industry circular

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stated that if the advertising materials 321(g)(1)(B). FDA evaluates health ‘‘moderation’’ was defined as no more also contained editorializing, claims on food labels pursuant to its than one drink per day for women and advertising slogans, or exhortations to authority under the FFDC Act, as no more than two drinks per day for consume the product, ATF would amended by the Nutrition Labeling and men. However, the 1995 Guidelines evaluate the additional text to determine Education Act (NLEA), Pub. L. 101–535 stressed that many people should not whether or not the advertisement (1990). The law provides that a food drink alcohol beverages at all, including presented a balanced picture of the risks product is misbranded if it bears a claim children and adolescents, women who associated with alcohol consumption. In that characterizes the relationship of a are trying to conceive or who are addition, ATF stated that the use of nutrient to a disease or health-related pregnant, individuals who plan to drive buttons, shelf talkers (additional condition, unless the claim is made in or take part in activities that require product information placed on the retail accordance with certain procedures attention or skill, and individuals using shelf), table tents, and similar items that mandated by FDA. 21 U.S.C. prescription and over-the-counter excerpt any portion of the NIAAA 343(r)(1)(B). FDA’s regulations provide medications. Finally, the 1995 publication, contain health slogans or that FDA will approve a health claim Guidelines suggested that individuals of other inferential statements drawn from when it determines, ‘‘based on the any age who could not restrict their this publication, or are based on any totality of publicly available scientific drinking to moderate levels should not other publication or article citing the evidence’’ that there is ‘‘significant drink at all. health benefits of alcohol consumption, scientific agreement, among experts VI. Competitive Enterprise Institute would be closely scrutinized to qualified by scientific training and Petition determine if they presented a balanced experience to evaluate such claims, that picture of the risks associated with the claim is supported by such On May 9, 1995, the Competitive alcohol consumption. evidence.’’ 21 CFR 101.14(c). Enterprise Institute (CEI) submitted a ATF reminded industry members in FTC’s general jurisdiction over petition asking ATF to issue a rule Industry Circular 93–8 that substantive advertising extends to alcohol allowing alcohol beverage labels and health claims on labels are considered beverages. In a policy statement advertisements to carry statements to be misleading unless they are published in the Federal Register on regarding the purported benefits of properly qualified, present all sides of June 1, 1994 (59 FR 28394), FTC stated moderate alcohol consumption. More the issue, and outline the categories of that it is necessary to examine ‘‘whether specifically, CEI proposed that ATF individuals for whom any positive qualified claims are presented in a issue a rule specifically allowing the effects on health would be outweighed manner that ensures that consumers following statement to appear on labels by numerous negative effects on health. understand both the extent of the and in advertisements: ‘‘There is Finally, ATF stated that it intended to support for the claim and the existence significant evidence that moderate initiate rulemaking on this issue; of any significant contrary view within consumption of alcoholic beverages may however, pending rulemaking, ATF the scientific community.’’ The FTC reduce the risk of heart disease.’’ By would continue to evaluate claims in policy statement stated that an letter dated November 10, 1995, CEI labeling and advertising on a case-by- unqualified health claim in the submitted a survey purporting to show case basis. advertising of a food was likely to be that less than 42 percent of the general deceptive if the food also contained a public was ‘‘aware of the medical IV. Role of Other Federal Agencies nutrient that increased the risk for benefits of moderate consumption.’’ With Respect to Specific Health Claims another disease or health-related By letter dated January 13, 1997, ATF and Other Health-Related Statements condition, and the risk-increasing denied CEI’s rulemaking petition. ATF While TTB now has primary nutrient was closely related to the determined that CEI’s proposed claim jurisdiction over the labeling and subject health claim. was not appropriately qualified, in that advertising of alcohol beverages, under it did not define the categories of certain circumstances the labeling and V. Fourth Edition of the Dietary individuals for whom there would be no advertising of alcohol beverages may Guidelines for Americans (1995) appreciable benefits (such as younger also be subject to the jurisdiction of the The Fourth Edition (1995) of the individuals already at low risk of heart Food and Drug Administration (FDA) or ‘‘Dietary Guidelines for Americans’’ was disease), or individuals for whom there the Federal Trade Commission (FTC). published by the U.S. Department of would be significant risks associated For example, since certain wine Agriculture (USDA) and the U.S. with moderate alcohol consumption products containing less than 7 percent Department of Health and Human (such as recovering alcoholics and alcohol by volume are not wines subject Services (HHS) in 1996. This edition of persons otherwise at risk for alcohol to the FAA Act, the labeling of such the Guidelines contained a detailed abuse, or people with certain medical products generally falls within FDA’s discussion of the health consequences conditions). The claim was not jurisdiction. ATF always utilized, as of alcohol consumption. balanced, in that it did not explain the TTB does now, the scientific and public The 1995 Guidelines acknowledged significant risks associated with higher health expertise of FDA in approving that ‘‘[c]urrent evidence suggests that levels of alcohol consumption, as well ingredients in alcohol beverages, moderate drinking is associated with a as the potential risks of moderate requiring label disclosure of certain lower risk for coronary heart disease in alcohol consumption for certain substances, and identifying adulterated some individuals.’’ The Guidelines then individuals. ATF found that the claim, alcohol beverages that are deemed went on to discuss the ‘‘serious health taken in isolation, would tend to mislabeled. problems’’ caused by higher levels of mislead the consumer about the By letter dated April 9, 1993, FDA alcohol consumption, including significant health consequences of advised ATF that certain curative, increased risk for high blood pressure, alcohol consumption. therapeutic, or disease-prevention stroke, and heart disease. Before ATF had issued its denial of claims for an alcohol beverage might The 1995 Guidelines recommended CEI’s petition, CEI had filed suit place the product in the category of a that if adults chose to drink alcohol (October 29, 1996) in the United States drug under the Federal Food, Drug and beverages, they should consume them District Court for the District of Cosmetic Act (FFDC Act), 21 U.S.C. only in moderation. The term Columbia, challenging ATF’s delay in

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acting on its petition. In 1997, CEI read wine labels, and that neither of the another label to the bottle to encourage amended its complaint to challenge two labeling statements would likely consumers to learn more about the ATF’s denial of the rulemaking petition. induce wine drinkers to alter their possible benefits of drinking wine.’’ In CEI also alleged that ATF had a ‘‘de drinking pattern, quantitatively or an article dated February 9, 1999, the facto’’ ban on the use of health claims, otherwise. However, several members of ‘‘San Francisco Examiner’’ stated that which violated the First Amendment the focus groups reported that ATF’s decision ‘‘would allow and the FAA Act. In 1998, the district information about the positive effects on winemakers to carry bottle labels court granted the Government’s motion health of wine consumption from the suggesting consumers check with their for summary judgment on CEI’s media had led them to increase their doctors or the government’s nutritional challenge to the denial of its rulemaking wine intake. guidelines on the possible health petition. Both parties filed motions for While the CSAP survey did not benefits of wine.’’ summary judgment on the remaining establish that the labeling statements VIII. Notice of Proposed Rulemaking issues. would influence the drinking patterns of wine drinkers, it did indicate that heavy On October 25, 1999, ATF invited VII. Other Health-Related Statements drinkers may justify or increase their comments on its current policy on on Alcohol Beverage Labels consumption levels based on their health claims and health-related On February 4, 1999, ATF approved independent understanding of statements by publishing the policy as two applications for certificates of label information regarding the alleged health a proposed regulation in the Federal approval bearing directional health- benefits of moderate consumption. Register (Notice No. 884; 64 FR 57413). related statements directing consumers Furthermore, the survey established that As proposed, labels or advertisements to the Dietary Guidelines or their family consumers would be no more likely to could not contain any statement, design, doctor for information about the ‘‘health seek additional health information after representation, pictorial representation, effects of wine consumption.’’ ATF reading the proposed labeling or device, whether explicit or implicit, approved those labels based on its statements. representing that consumption of determination that the statements were Based on the evidence before it, alcohol beverages has curative or not substantive health claims, but including the consumer survey therapeutic effects if such statement is instead were neutral statements conducted by CSAP, ATF concluded untrue in any particular or tends to directing consumers to third parties for that there was insufficient evidence in create a misleading impression. A additional information regarding the the record to establish that the substantive claim regarding health effects on health of alcohol directional statements tended to mislead benefits associated with the use of an consumption. The first approved consumers about the effects on health of alcohol beverage would be misleading labeling statement read as follows: alcohol consumption. Accordingly, the unless such claim was properly labels were approved. qualified and balanced, sufficiently The proud people who made this wine The approval of these labels generated encourage you to consult your family doctor detailed and specific, and outlined the considerable interest from Federal about the health effects of wine consumption. health officials, members of Congress, categories of individuals for whom any The second labeling statement read as and public advocacy groups, who positive effects on health would be follows: expressed concern about consumer outweighed by numerous negative effects on health. To learn the health effects of wine perception of the label statements. Of consumption, send for the Federal particular note, former Surgeon General ATF also sought comments on Government’s Dietary Guidelines for David Satcher expressed concern that whether even balanced and qualified Americans, Center for Nutrition Policy and people might draw an incorrect message health claim statements should be Promotion, USDA, 1120 20th Street, NW., from these labels. prohibited because the negative Washington, DC 20036 or visit its web site: Moreover, ATF became aware of a consequences of alcohol consumption http://www.usda.gov/fcs/cnpp.htm. number of press accounts interpreting are so serious as to make any health- Prior to being approved, the two the directional statements as actual related statement on labels or in applications received a great deal of health claims about the benefits of advertisements inherently misleading. public attention. In July of 1997, both alcohol consumption. For example, on In addition, ATF sought comments on HHS and FTC urged ATF not to approve February 5, 1999, the ‘‘Wall Street whether health-related directional the labels until a consumer survey was Journal’’ wrote that the expected statements such as those approved in conducted. In that same month, decision to approve the labels would February 1999 tend to mislead Senators Robert Byrd and Strom allow ‘‘wine producers to put labels on consumers about the health Thurmond wrote to the Secretary of the bottles that point to the potential health consequences of alcohol consumption. Treasury, also raising several concerns benefits of their product.’’ On February The comment period for Notice No. about the proposed labeling statements. 5, 1999, the Associated Press reported 884, initially scheduled to close on ATF also received several letters from the decision as follows: ‘‘Scientific February 22, 2000, was extended until public health organizations concerned studies have suggested it, and now June 30, 2000, pursuant to Notice No. that the labels would encourage winemakers finally may get a chance to 896. (See following section, ‘‘Notice of consumers to consume alcohol tout it through their labeling: A glass or Hearings.’’) two of the grape each day could be good beverages for health reasons. In view of IX. Notice of Hearings these concerns, ATF decided to defer for you.’’ On February 6, 1999, the ‘‘Los final action on the labels pending the Angeles Times’’ reported that ‘‘[t]he On December 9, 1999, ATF completion of a consumer survey by the federal government approved changes announced in a press release that after Center for Substance Abuse Prevention Friday that will allow winemakers for the close of the comment period, it (CSAP), a component of HHS. the first time to tout on labels the would hold public hearings on the issue In January of 1998, CSAP transmitted connection between drinking wine and of health claims in the labeling and to ATF the main findings from its better health.’’ That same date, the advertising of alcohol beverages. ATF consumer survey. The survey found that ‘‘Washington Post’’ reported that ATF stated that the hearings would provide most subjects reported that they do not had ‘‘decided that winemakers may add it with a comprehensive record on

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which to base final regulations on liver cirrhosis; and trauma, including drinkers, and that there are other ways health claims. trauma from traffic crashes. Moderate of reducing the risk of heart disease: Because it was seeking public drinking is not risk free. The trade-offs Drinking in moderation may lower risk for comments on this very issue, ATF between risks and benefits can be coronary heart disease, mainly among men announced that it would suspend action exemplified by the fact that alcohol’s over age 45 and women over age 55. on any new applications for label anticlotting ability, potentially However, there are other factors that reduce approval bearing similar health-related protective against heart attack, may the risk of heart disease, including a healthy directional statements pending the increase the risk of hemorrhagic stroke, diet, physical activity, avoidance of smoking, completion of the rulemaking or bleeding within the brain.’’ and maintenance of a healthy weight. proceeding. ATF noted that due to the (Footnotes omitted). Moderate consumption provides little, if any, adverse consequences of alcohol In a commentary that appeared with health benefit for younger people. Risk of alcohol abuse increases when drinking starts consumption, it was concerned about the Alert, NIAAA Director Enoch at an early age. Some studies suggest that any risk of misperception resulting from Gordis, M.D., offered the following older people may become more sensitive to the two approved statements. advice with respect to the health the effects of alcohol as they age. On February 28, 2000, ATF published implications of alcohol consumption: The 2000 Dietary Guidelines a notice in the Federal Register (1) Individuals who are not currently announcing the dates and locations of recommend that if adults choose to drinking should not be encouraged to drink drink alcohol beverages, they should five hearings that it planned to hold solely for health reasons, because the basis concerning the proposed regulations for health improvements has not yet been consume them only in moderation. The (Notice No. 892; 65 FR 10434). ATF established as deriving from alcohol itself; term ‘‘moderation’’ is defined as no subsequently canceled the hearings that (2) Individuals who choose to drink and more than one drink per day for women were scheduled for Atlanta, Chicago, are not otherwise at risk for alcohol-related and no more than two drinks per day for problems should not exceed the one-to two- and Dallas, due to the low number of men. The Dietary Guidelines also drink-per-day limit recommended by the U.S. conclude that for some people, even requests to present oral comments in Dietary Guidelines; and those locations (Notice No. 896; 65 FR moderate drinking is not recommended. (3) Individuals who currently are drinking Thus, many people should not drink 24158). In addition, the hearings beyond the U.S. Dietary Guidelines’ scheduled for Washington, DC and San recommended limits should be advised to alcohol beverages at all, including Francisco, California, were limited to lower their daily alcohol intake to these children and adolescents; individuals of two days each. The hearing in limits. any age who cannot restrict their drinking to moderate levels; women Washington, DC was held on April 25– B. Dietary Guidelines—Fifth Edition who may become pregnant or who are 26, 2000, and the hearing in San (2000) pregnant; individuals who plan to drive, Francisco was held on May 23–24, 2000. In the summer of 2000, USDA and ATF also extended the close of the operate machinery, or take part in other HHS published the ‘‘Dietary Guidelines activities that require attention, skill, or comment period regarding Notice No. for Americans, 2000.’’ The 2000 Dietary 884 from February 22, 2000, to June 30, coordination; and individuals taking Guidelines contain more specific prescription or over-the-counter 2000. Written comments addressing guidance about alcohol consumption, testimony presented at the hearings medications that can interact with and summarize the current medical alcohol. could also be submitted up until June evidence regarding the risks associated 30, 2000. with alcohol consumption as follows: C. Recent Developments in the CEI Litigation X. Recent Developments Alcoholic beverages supply calories but On June 18, 2001, the district court A. 1999 Alcohol Alert few nutrients. Alcoholic beverages are harmful when consumed in excess, and some granted the Government’s motion for In 1999, NIAAA published an people should not drink at all. Excess alcohol summary judgment on the remaining ‘‘Alcohol Alert’’ on ‘‘Alcohol and alters judgment and can lead to dependency issues in the CEI litigation. The court Coronary Heart Disease’’ (No. 45–1999). and a great many other serious health ruled that the case was not ready for In this publication, NIAAA reaffirmed problems. Taking more than one drink per judicial review given the fact that ATF day for women or two drinks per day for men that ‘‘[r]esearch has revealed an * * * can raise the risk for motor vehicle was in the middle of a rulemaking association between moderate alcohol crashes, other injuries, high blood pressure, proceeding on the very issues raised by consumption and lower risk for CHD.’’ stroke, violence, suicide, and certain types of CEI in the litigation. The plaintiffs (Footnote omitted). However, NIAAA cancer. Even one drink per day can slightly appealed this decision to the Court of cautioned that ‘‘[a]n association raise the risk of breast cancer. Alcohol Appeals. On May 10, 2002, the appellate between moderate drinking and lower consumption during pregnancy increases risk court upheld the district court’s ruling risk for CHD does not necessarily mean of birth defects. Too much alcohol may cause that the case was not ripe (ready) for that alcohol itself is the cause of the social and psychological problems, cirrhosis judicial review because ATF was of the liver, inflammation of the pancreas, lower risk. For example, a review of and damage to the brain and heart. Heavy nearing completion of a rulemaking population studies indicates that the drinkers are also at risk of malnutrition proceeding on the use of health claims. higher mortality risk among abstainers because alcohol contains calories that may Thereafter, the plaintiffs filed a petition may be attributable to shared traits other substitute for those in nutritious foods. If for rehearing with the Court of Appeals than the participants’ nonuse of adults choose to drink alcoholic beverages, that was denied. alcohol.’’ (Footnote omitted). NIAAA they should consume them only in noted that ‘‘[t]he role of exercise in the moderation * * * and with meals to slow XI. Analysis of Comments Received in alcohol-CHD association requires alcohol absorption. Response to Notice No. 884 additional study.’’ The 2000 Dietary Guidelines also In response to Notice No. 884, ATF NIAAA noted that ‘‘[t]he apparent contain a discussion of the possible received 535 comments. Comments benefits of moderate drinking on CHD health benefits of alcohol consumption; were submitted by several United States mortality are offset at higher drinking however, the following excerpt from Senators, two Federal agencies, an levels by increasing risk of death from this section emphasizes that these agency of a foreign government, other types of heart disease; cancer; benefits accrue primarily to older consumers and consumer organizations,

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medical professionals (including the authorization of any directional B. Decision physicians, nurses, and local health statement on a label would be in After carefully considering the record, departments), public health violation of the ABLA. TTB does not TTB has determined that it is important organizations, industry members, and agree with this legal analysis. This issue to issue a final rule on specific health others. will be discussed further in section XIII. claims and other health-related As previously noted, in Notice No. DISCUS and Beer Institute also statements in the labeling and 884 ATF sought comments on whether objected to the proposed advertising advertising of alcohol beverages. The the serious health risks associated with regulations. DISCUS suggested that rulemaking record confirms that alcohol alcohol consumption meant that any ATF’s proposal was ‘‘insurmountably abuse is an important public health health claim, even a balanced and vague and ambiguous. It only would issue. The use of health claims and qualified one, was inherently serve to interfere with the rights of health-related statements in the labeling misleading to consumers. In response, advertisers to engage in truthful, non- and advertising of alcohol beverages approximately 45 commenters misleading speech about their products requires a balance between a producer’s supported the use of substantive health that are consumed responsibly by over First Amendment right to label and claims or health-related statements in a hundred million Americans.’’ DISCUS advertise its products in a truthful and the labeling and advertising of alcohol suggested that ‘‘[a]n advertiser could non-misleading fashion and the public’s beverages. On the other side, run afoul of the provisions of BATF’s right to be informed of the significant approximately 120 commenters opposed proposed rule without making any type health risks associated with alcohol the use of either substantive health of curative or therapeutic claim,’’ giving consumption. Specific regulations on claims or health-related directional as an example an advertisement the use of health claims and other statements in the labeling or advertising depicting attractive individuals relaxing health-related statements in the labeling of alcohol beverages. Many of these in an enjoyable setting. The Beer and advertising of alcohol beverages commenters suggested that health Institute similarly suggested that the will ensure that both the industry and statements were inherently misleading requirements for labeling and the public are aware of the restrictions when used to market alcohol beverages. advertising should be separate, and that on the use of labeling and advertising ATF specifically sought comments on the proposed regulation complicated the statements that might tend to mislead whether health-related directional existing advertising standard. The Beer the consumer about the serious health labeling statements such as the ones Institute suggested that the current risks associated with alcohol approved in February 1999 tended to standard is readily understood and consumption. mislead consumers about the health straightforward, and that instead of TTB recognizes that based on the consequences of alcohol consumption. issuing new regulations, ATF should administrative record, it does not appear The vast majority of the commenters adopt a more formal review process of that distillers and brewers are interested focused exclusively on this issue. health statements on a case-by-case in using health claims or health-related Approximately 355 comments basis. statements in the labeling or advertising supported the use of health-related These commenters also suggested that of alcohol beverages. However, as noted directional statements on alcohol large portions of the alcohol beverage later in this preamble, both the Wine beverage labels. The major issues raised industry had no interest in using health Institute and the American Vintners by the commenters, as well as the claims in the labeling or advertising of Association (AVA), two industry individuals who testified at the public their products. For example, the Beer associations representing hundreds of hearings, are summarized below. Institute comment suggested that there wineries, supported ATF’s proposed XII. Is There a Need To Engage in was no need to amend the malt beverage rule regarding substantive health claims. Rulemaking on This Issue? regulations, since to its knowledge, At least one individual testifying at the none of its constituents had ever used hearing, Mr. John Hinman, indicated A. Issue such claims in the past, and none had that there were wineries interested in Four comments either opposed ATF’s any intention to do so in the future. using a 664-word substantive health decision to engage in rulemaking on this NABI raised similar concerns, and claim in advertising materials. The issue or suggested that the notice of stated that it did not support the Wine Institute and AVA, as well as proposed rulemaking be withdrawn. proposed amendment to the regulations many individual wineries, commented These were comments submitted by the ‘‘because any such support might imply in favor of allowing directional Beer Institute, a trade association for the industry intends to make health- statements in the labeling of alcohol domestic and international brewers; the related statements on its labels and in beverages. Thus, the record reflects that National Association of Beverage its advertising.’’ The comment from there may be some wineries interested Importers (NABI), a trade association DISCUS stressed that ‘‘America’s in using substantive health claims in the representing importers of beer, wine, distillers do not recommend that advertising of alcohol beverages, and and distilled spirits; the Distilled Spirits consumers drink beverage alcohol for that many wineries are interested in Council of the United States (DISCUS), health reasons.’’ (Comment 530). using directional statements on labels. a national trade association representing CEI, a pro-market public interest For this reason, TTB believes it is producers and marketers of distilled group dedicated to advancing the important to issue regulations that set spirits and importers of wine; and a principles of free markets and limited forth the standards that must be met in comment submitted jointly by CEI and government, and CA, a free-market the event that a specific health claim or Consumer Alert (CA). consumer advocacy group, suggested other health-related statement is used in DISCUS, the Beer Institute, and NABI that the proposed rule should be the labeling or advertising of alcohol all questioned the necessity for engaging withdrawn because the issuance of a beverages. As set forth later in section in rulemaking on the issue of health regulation based on the proposal would XVII, the same standards should apply claims and health-related statements in restrict commercial speech in a way that to wines, distilled spirits, and malt the labeling and advertising of alcohol violates the First Amendment. beverages, even if there is no evidence beverages. (Comments 530, 396, and (Comment 326). These issues will be that any members of the malt beverage 522). These comments suggested that discussed further in section XIX. or distilled spirits industries are

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interested in using health claims or enacted in 1988. Pursuant to 27 U.S.C. beverage labels. Thus, it is clear that the health-related statements. The rule does 215, alcohol beverage containers statute does not specifically preclude not require anyone to use such distributed or sold in the United States the voluntary use of additional health- statements; it merely sets forth the must bear a Government warning related statements on alcohol beverage standards that would apply in the event statement, which warns that alcohol labels. that an industry member wishes to use consumption during pregnancy may XIV. What Are the Effects on Health of a specific health claim or a health- cause birth defects; that alcohol Alcohol Consumption? related statement on a label or in an consumption impairs one’s ability to advertisement. drive a car or to operate machinery; and A. Issue TTB does not agree that the proposed that consumption of alcohol beverages Most of the commenters who regulations would inject uncertainty ‘‘may cause health problems.’’ addressed this issue agreed that there Some commenters argued that the with respect to the use of was a link between moderate alcohol ABLA provided ATF with authority to advertisements that do not involve consumption and a reduced risk of heart health claims or health-related deny any statement on an alcohol beverage label that discusses the disease in certain individuals. However, statements, such as the example some commenters concluded that the provided by DISCUS of an relationship between alcohol consumption and health. The ABLA risks associated with alcohol advertisement that shows people consumption greatly outweighed any relaxing in an attractive setting. There is provides that ‘‘[n]o statement relating to alcoholic beverages and health, other purported cardiovascular benefits, while nothing in the proposed rule that would other commenters emphasized the extend the definition of a health claim than the statement required by section 204 [27 U.S.C. 215] of this title, shall be benefits associated with moderate or curative or therapeutic claim to cover consumption. such advertisements. However, we agree required under State law to be placed on any container of an alcoholic beverage, CEI and CA presented a review of the that the lack of any definition of a medical evidence summarized by ‘‘curative or therapeutic claim’’ or or on any box, carton, or other package, irrespective of the material from which Michael Gough (Ph.D.), which ‘‘health claim’’ in the proposed rule concluded that most adults would might give rise to some uncertainty as made, that contains such a container.’’ This section of the law preempts State benefit from moderate alcohol to what types of advertising claims consumption. Dr. Gough stated that would be covered by the regulation. governments from each requiring their own version of a health warning ‘‘with the exception of those well- Accordingly, the final rule includes defined groups of people who should definitions of the terms ‘‘health-related statement on alcohol beverage containers. However, it in no way avoid alcohol, there is clearly statement’’ (which includes statements convincing evidence for the health of a curative or therapeutic nature), precludes producers from voluntarily placing either additional warning benefits of moderate alcohol ‘‘specific health claims,’’ and ‘‘health- consumption.’’ Dr. Gough related directional statements.’’ We statements or health claims on alcohol beverage labels. See also 27 U.S.C. 213 acknowledged that individuals in their believe that these definitions should 20s and 30s do not accrue net benefits resolve any concerns by the commenters (setting forth Congress’ policy to ensure that the public is adequately reminded from consuming alcohol since they are that the labeling or advertising at low risk for heart disease; however, regulations are intended to broaden about any health hazards that may be associated with alcohol consumption or he suggests that ‘‘[b]ased on ATF’s traditional interpretation of a understanding of the biological basis for curative or therapeutic claim. abuse, and not impeded by ‘‘diverse, nonuniform, and confusing the protective effects of alcohol, it is XIII. Does the ABLA Preclude the Use requirements for warnings or other likely that moderate alcohol of Specific Health Claims or Other information on alcoholic beverage consumption in the 20s and 30s is Health-Related Statements on the containers with respect to any important to the beneficial effects seen Labels of Alcohol Beverages? relationship between the consumption in later years.’’ or abuse of alcoholic beverages and CEI attached numerous medical A. Issue health’’). studies regarding the effects on health of Five commenters, including Senator Some commenters argued that 27 alcohol consumption. In most important Thurmond (Comment 526), DISCUS U.S.C. 217 provides the exclusive respects, the studies were consistent (Comment 530), the Beer Institute method for allowing additional with ATF’s summary of the medical (Comment 396), NABI (Comment 522), statements regarding alcohol evidence in Notice No. 884. Several of and Remy Amerique, Inc. (Comment consumption and health on the label. the studies reported an association 531), suggested that the use of any Section 217 provides that if the between light to moderate alcohol health claims or other health-related Secretary, after consulting with the consumption and a reduced risk of heart statements on alcohol beverage labels Surgeon General, determines that there disease. However, many of these same was foreclosed by the provisions of the should be a change in the mandatory studies supported the conclusion that ABLA. They argued that it was health warning statement, or if such the health benefits of alcohol Congress’ intent to foreclose the use of statement should be deleted, he shall consumption do not apply to certain any other health-related statements on report such information to the Congress groups. alcohol beverage labels. together with specific recommendations For example, the authors of one study for necessary amendments to the ABLA. began by noting that ‘‘[m]en and women B. Decision After soliciting public comments on this who drink alcoholic beverages regularly TTB does not agree with those issue, ATF determined in 1993 that have, in comparison with abstainers, commenters who suggested that the there was no need to seek changes to the higher death rates from injuries, ABLA specifically precludes the required health warning statement. violence, suicide, poisoning, cirrhosis, voluntary use by industry members of However, this provision applies only to certain cancers, and possibly any health-related statements on alcohol the required health warning statement, hemorrhagic stroke, but lower death beverage labels other than the required not to voluntary statements that rates from coronary heart disease and warning statement. The ABLA was producers seek to place on alcohol thrombotic stroke. The net balance of

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risks and benefits is likely to differ in a link between moderate alcohol associated with cardiovascular diseases different age groups and populations.’’ 6 consumption and reduced risk of such as cardiomyopathy, hypertension, (Footnotes omitted). One of the cardiovascular disease (Comment 401). arrhythmias and stroke.’’ The Marin conclusions of the study is that ‘‘the In its summary of these studies, the Institute identified similar health risks balance of adverse and beneficial effects Wine Institute asserted that moderate associated with alcohol consumption. of drinking on mortality from all causes drinkers have a 40–50 percent reduction (Comment 324). depends not only on the amount of in coronary artery disease risk compared Many recognized experts on the alcohol consumed but also on age and with individuals who are abstinent, effects on health of alcohol background cardiovascular risk.’’ 7 with a lower overall mortality rate as consumption testified at the public Another article noted that it has not well. hearings held by ATF in Washington, yet been determined how alcohol As ATF stated in Notice No. 884, the DC and San Francisco, California. Dr. reduces the risk of coronary heart serious health risks associated with David Satcher, former Assistant disease. The authors stated that: 8 alcohol consumption are well Secretary for Health and Surgeon Several possible mechanisms for a established, and ATF received many General, testified about the public protective role of alcohol against coronary comments from public health health dangers associated with alcohol disease have been hypothesized, including organizations that focused on those consumption as follows: adverse consequences. The major points alcohol-mediated increases in HDL Although the majority of Americans who cholesterol levels. * * * Knowledge of the made by these commenters are consume alcoholic beverages do so safely, basic mechanisms by which alcohol exerts a summarized below. alcohol is one of the nation’s leading causes protective effect against coronary heart Many of the commenters focused on of preventable injury and premature death. disease is critical to assessing the potential the serious public health risks Each year, over 100,000 premature deaths importance of moderate alcohol consumption associated with alcohol abuse. The result from alcoholism and alcohol abuse. to the public health, particularly if the National Council on Alcoholism and Alcohol represents, therefore, the third beneficial effects of alcohol can be achieved leading cause of premature death, right through other interventions. Because heavy Drug Dependence, Inc. (NCADD) behind tobacco and physical inactivity. consumption of alcohol has been implicated commented that ‘‘[w]hile most people Traffic crashes involving alcohol killed more in accidents, cirrhosis, cancer, and other who choose to drink do so without than 16,000 people in 1997, and one in four adverse outcomes, the difference between negative health or life consequences, drinking small-to-moderate quantities of there are 13.8 million Americans over victims of violent crime report that the alcohol and drinking large amounts may offender had been drinking alcohol prior to the age of 18 who have problems with committing the crime. Fetal alcohol mean the difference between preventing and drinking, including 8.1 million people causing disease. Any clinical syndrome continues to be the leading who are alcoholic. Millions of others, preventable cause of mental retardation. I recommendations based on this because of a family history or the epidemiologic evidence should therefore be think we fail to appreciate that the roots of cautious. (Footnotes omitted). addictive potential of alcohol, are at risk alcoholism and alcohol abuse have their for developing an addiction.’’ (Comment origins in adolescence and that children are Among the more recent studies 15). NCADD noted that alcohol especially vulnerable to its dangers. Alcohol submitted by CEI and CA was one that contributes to 100,000 deaths annually, is the nation’s number one drug problem focused on the effects on health of making it the third leading cause of among youth, and it is involved in teen alcohol consumption on women. The preventable mortality in the United automobile crashes, homicides, and suicides, authors noted that before beginning the the three leading causes of teen death. (April States, after tobacco and diet/activity 25, 2000; Washington, DC, pages 72–73). study, it was unclear ‘‘[w]hether the patterns. While there are fewer deaths apparent overall benefit of light-to- from alcohol-related causes than from Other physicians testified regarding moderate alcohol intake among men’’ cancer or heart disease, alcohol-related the effects on health of alcohol could be extrapolated to women, noting deaths tend to occur at much younger consumption. Dr. Carlos Camargo, an that ‘‘[a]s compared with men, women ages. emergency room physician and alcohol have a lower risk of coronary heart Some commenters focused on the cost researcher, testified at the invitation of disease, attain higher blood alcohol to society associated with alcohol abuse. CSPI. He stated that ‘‘there is persuasive concentrations for a given amount of For example, the Center for Science in evidence that moderate alcohol alcohol consumed, and are more the Public Interest (CSPI) commented consumption reduces risk of coronary susceptible to alcoholic liver disease. that ‘‘[a] substantial body of evidence heart disease in some people. There is Moreover, women who consume has shown a positive relationship also persuasive evidence that even moderate quantities of alcohol have an between the aggregate consumption of moderate drinking carries significant increased risk of breast cancer.’’ 9 alcohol in society and population rates health risks for many people.’’ (April 25, (Footnotes omitted). The results of the of alcohol-related diseases, accidents, 2000; Washington, DC, page 94). study showed that light to moderate criminal violence, and suicide. Dr. Michael Criqui, a physician, female drinkers had a reduced risk of According to the National Institute on epidemiologist, and professor, also heart disease, with women who drank Alcohol Abuse and Alcoholism expressed concerns regarding the use of one to three drinks per week having the (NIAAA), alcohol abuse and alcoholism any health-related statement in lowest risk of mortality.10 However, the cost society more than $166 billion connection with the labeling of alcohol study concluded that ‘‘the apparent annually and each year over 110,640 beverages. Dr. Criqui stressed that when benefit of light-to-moderate alcohol deaths have alcohol-related causes.’’ evaluating the potential health benefits consumption was mainly confined to (Comment 400). (Footnotes omitted). associated with alcohol consumption, it women at greater risk for coronary heart Many of the commenters set forth the is important to look at the effects of disease, specifically older women and serious risks associated with higher various diseases on the potential years women with one or more coronary risk levels of alcohol consumption. NCADD of life lost before age 75. He noted that factors.’’ 11 noted that ‘‘[h]eavy and chronic while heart disease is the single largest The Wine Institute, representing over drinking can harm virtually every organ cause of death in developed countries, 500 California winery and associate and system in the body, and is the it usually occurs at older ages. Motor members, also submitted summaries of single most important cause of illness vehicle crashes and suicides together several medical studies that established and death from liver disease. It is also cause the loss of more potential years of

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life in men than heart disease, and both Because TTB is not an expert on Risk of alcohol abuse increases when are linked to alcohol use. In women, public health issues, we (and our drinking starts at an early age. Some breast cancer and motor vehicle predecessors) have generally deferred to studies suggest that older people may accidents each account for more the findings of the Department of Health become more sensitive to the effects of potential years of life lost before age 75 and Human Services, including NIAAA, alcohol as they age. than heart disease. (May 23, 2000; San FDA, CSAP, and the Surgeon General, Based on the above, it is TTB’s Francisco, CA, pages 53–54). on issues related to the effects on health conclusion that the medical data still Dr. Criqui also stressed the of alcohol consumption. In the case at supports ATF’s longstanding (and now importance of evaluating the patterns of hand, TTB finds that the evidence in the our) position that notwithstanding the consumption among drinkers. He said rulemaking record supports the findings data linking moderate alcohol that in the United States, about 80% of of NIAAA’s 1999 ‘‘Alcohol Alert’’ and consumption to a reduced risk of heart men and 70% of women drink alcohol, the 2000 Dietary Guidelines published disease in some individuals, there are with 50% of drinkers reporting by USDA and HHS. The main points of significant health risks associated with temporary problems with alcohol. (Id. at these findings can be summarized as all levels of alcohol consumption. The page 55). About 10% of men and 5% of follows: medical data submitted by the • women are alcoholics. Furthermore, Dr. Alcohol beverages are harmful commenters, as well as the testimony Criqui stated that ‘‘half of all the alcohol when consumed in excess, and some presented by experts at the public consumed in the United States is people should not drink at all. Excess hearings, suggest that there is a link consumed by the 10% of men and the alcohol alters judgment and can lead to between moderate alcohol consumption 5% of women who are alcohol- dependency and many other serious and a reduced risk of heart disease in dependent.’’ (Id. at page 57). problems. Heavy levels of alcohol certain individuals; however, causation consumption cause social and Other medical professionals stressed has not been conclusively established. psychological problems, cirrhosis of the the health benefits associated with The risk/benefit ratio varies with the liver, inflammation of the pancreas, and moderate drinking for persons who do individual’s own health profile and the damage to the brain and heart. not belong in the categories of • level of consumption. For example, Taking more than one drink per day moderate alcohol consumption confers individuals for whom alcohol for women or two drinks per day for consumption is contraindicated. Dr. few, if any, benefits on people at low men can raise the risk for motor vehicle risk for heart disease. The evidence also Curtis Ellison, a Professor of Medicine, accidents, other injuries, high blood testified that ‘‘science clearly indicates establishes that there are serious risks pressure, stroke, violence, suicide, and associated with higher levels of alcohol that moderate drinkers have much lower certain types of cancer. Even one drink risk of coronary heart disease and consumption, and that even moderate per day can slightly raise the risk of consumption poses health risks for ischemic stroke. Because these are the breast cancer. number one and number three causes of • certain individuals. Finally, there are Alcohol consumption during certain categories of individuals for death, it is not surprising that moderate pregnancy increases the risk of birth drinkers will live longer in the United whom any level of alcohol consumption defects. is not recommended. States.’’ (April 26, 2000; Washington, • Certain individuals should not DC, page 109). Dr. Ellison suggested that drink any alcohol; for these individuals, XV. Are Health Claims and Health- ‘‘if I am withholding from a patient even moderate levels of alcohol Related Statements in the Labeling and information that may reduce that consumption may cause health risks. Advertising of Alcohol Beverages individual’s risk of a heart attack by 30 Included in this category are children Inherently Misleading? or 40 percent and do not tell him about and adolescents; individuals of any age A. Comments in Opposition to the Use it, I am doing him a disservice.’’ (Id. at who cannot restrict their drinking to of Health Claims and/or Health-Related page 110). moderate levels; women who may Statements B. Decision become pregnant or who are pregnant; individuals who plan to drive, operate Approximately 120 comments The evidence presented by the machinery, or take part in other opposed the use of health claims and/ medical experts, as well as the studies activities that require attention, skill, or or health-related statements (including presented with some of the comments, coordination; and individuals taking directional statements) in the labeling indicate that there are differences of prescription or over-the-counter and advertising of alcohol beverages. opinion as to how the relative risks and medications that can interact with Many of these commenters, including benefits of alcohol consumption should alcohol. the American Medical Association, the be weighed. The evidence reflects a • Moderate levels of alcohol American Cancer Society, and the broad consensus that heavy levels of consumption are associated with a Center for Science in the Public Interest, alcohol consumption pose serious reduced risk of coronary artery disease commented in support of a complete health risks. The record also reflects that for certain individuals, but causation ban on the use of such statements in the there is a broad consensus that certain has not been conclusively established. labeling or advertising of beverage categories of people should not • To the extent that moderate alcohol. The primary arguments made consume any alcohol. With regard to consumption is linked to a lowered risk by these commenters are summarized those individuals for whom alcohol for coronary heart disease, the link below. consumption is not contraindicated, appears mainly among men over 45 and 1. It Has Not Been Proven That there was some difference among the women over age 55. Moderate Moderate Alcohol Consumption Lowers experts as to how to weigh the relative consumption provides little, if any, the Risk of Heart Disease risks and benefits of moderate health benefit for younger people. consumption, with some experts • The effects on health of alcohol NCADD commented that the evidence stressing the protection against consumption vary from individual to for the alleged health benefits of alcohol cardiovascular disease, and other individual, depending on the consumption was ‘‘far from concrete,’’ experts stressing the increased risk of individual’s health profile and history, noting that the 1999 NIAAA report injury and certain cancers. as well as the levels of consumption. concludes that while there is ‘‘an

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association between moderate drinking (2) the health benefits of moderate alcohol U.S. adult population, have been and a lower risk of CHD, science has not consumption do not apply universally, but exposed to alcoholism in the family. confirmed that alcohol itself causes the only to a discrete segment of the population; Almost one in five (18%) of American lower risk.’’ ‘‘Alcohol Alert,’’ National (3) there are many groups of people who adults lived with an alcoholic while should abstain from, or minimize, their growing up. Its comment also noted the Institute on Alcohol Abuse and consumption of alcohol; Alcoholism, No. 45, October 1999. (4) allowing health claims would negative impact of alcoholism on family (Comment 15). Most other commenters, undermine the Government warning label; and marital relationships, the however, acknowledged that there was and association between alcoholism and a link or association between moderate (5) explanatory statements are insufficient violent crime and child abuse, and the alcohol consumption and reduced risk to clarify a misleading health claim. devastating impact of alcoholism on the of heart disease in some individuals. (Comment 400). children of alcoholics. CSPI noted that researchers for the The Marin Institute for the Prevention 2. Because the Negative Health of Alcohol and Other Drug Problems Consequences of Alcohol Consumption Centers for Disease Control and Prevention (CDC) found that, after (‘‘Marin Institute’’) commented in favor Outweigh the Potential Benefits, Health of a complete ban on all health-related Claims and Health-Related Statements decreasing during the late 1980s, alcohol consumption among pregnant statements (other than the required Are Inherently Misleading and Should warning statement) in the labeling and Be Banned women in the United States began to increase after 1991, and the lead author advertising of alcohol beverages. (Comment 324). The Marin Institute Many of the commenters stated that hypothesized that the increased commented that ‘‘[s]tatements health claims for alcohol beverages were consumption might be due to the media attributing positive health effects to the inherently misleading because the attention to the reports on the health consumption of alcoholic beverages (as health risks associated with alcohol benefits of moderate drinking. At the is the case with the previously approved consumption outweigh the purported Washington, DC hearing, Mr. George wine labels) are misleading and cardiovascular benefits. For example, Hacker, director of CSPI’s Alcohol potentially dangerous because media the American Cancer Society Policies Project, testified in opposition and marketing messages can be commented in favor of a ban on all to the use of health claims. Mr. Hacker misinterpreted as public health health benefit claims and health-related stressed the health risks associated with recommendations.’’ They stated that statements in the labeling and even moderate alcohol consumption, ‘‘[s]implistic and misleading messages advertising of alcohol beverages. and stated that ‘‘[a]lcohol is a about the health effects of alcohol are (Comment 527). They noted that potentially dangerous, potentially dangerous to the health and safety of ‘‘[w]hile moderate intake of alcohol has addictive, and potentially deadly drug. Americans and could increase the been shown to reduce the risk of Any positive health statement about enormous toll of alcohol-related coronary heart disease in middle-aged such a drug must be presented, if at all, problems in this country. Because of the adults, 100,000 deaths each year are only in a balanced and non-misleading evidence regarding the risks associated attributed to alcohol-related diseases.’’ manner.’’ (April 25, 2000; Washington, with alcohol consumption, alcoholic The American Medical Association DC, page 56). beverages should not be held to a lower (AMA) strongly urged ATF to reject any On behalf of its three million standard of accountability regarding type of beneficial claim for alcohol members and supporters, Mothers health messages than well-regulated products on container labels, noting that Against Drunk Driving (MADD) prescription drugs. Banning all health such claims would be misleading, and commented in favor of banning any claim-related statements on labels or in for many persons, inaccurate. (Comment health claims or directional statements advertising of alcoholic beverages 534). AMA stated that ‘‘[w]hile some in the labeling and advertising of assures that public health information is research indicates that moderate alcohol beverages. (Comment 20). accurate and free of potentially harmful drinking is associated with a decreased MADD commented that ‘‘[t]he negative misinformation.’’ risk of some diseases, other research consequences and the risk associated Other public health organizations shows that such risks actually with alcohol consumption greatly strongly urged a ban on health claims. substantially increase for certain outweigh any purported ‘health See, Pacific Drug Policy Institute, Inc. people.’’ benefits.’’’ MADD quoted Gen. Barry (Comment 34); American Council on McCaffrey, former Director of the Office Senator Strom Thurmond opposed the Alcohol Problems (Comment 37); and of National Drug Control Policy, as West Los Angeles Alcohol Policy use of any health-related statements on telling an alcohol policy conference in alcohol beverage labels. (Comment 526). Coalition (Comment 384). 1997 that, ‘‘Undoubtedly, alcohol is the Many individuals made similar He testified that health claims were principal drug abuse problem in comments, noting the serious health inherently misleading because of the America today.’’ risks associated with alcohol serious health risks associated with MADD also noted that in 1998, 15,935 consumption. Some shared personal alcohol consumption; because the people were killed in alcohol-related experiences with alcoholism or alcohol supposed health benefits of moderate traffic crashes and an estimated 850,000 abuse. See comments 23, 28, and 35. drinking have not been conclusively were injured. These alcohol-related Many of the individuals testifying at established; and because any crashes result in an annual cost of the public hearings also emphasized the explanatory statements are simply $114,800,000 in the United States. human costs associated with alcohol insufficient to clarify a misleading The National Association for Children abuse. For example, Barrett Duke, Ph.D., health claim. (April 25, 2000; of Alcoholics commented that ‘‘the testified on behalf of the Ethics and Washington, DC, pages 14–16). health risks of alcohol far outweigh the Religious Liberty Commission, the CSPI argued that health claims are health benefits’’ and advocated a moral concerns agency for the Southern inherently misleading for five reasons: complete ban on health-related claims Baptist Convention. He shared his (1) There are serious health risks associated on alcohol beverage containers. concerns from the perspective of the with alcohol consumption, even moderate (Comment 29). This comment noted that faith community, and noted that ‘‘[m]ost consumption; 76 million Americans, about 43% of the faith communities deal with the

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devastating consequences of alcohol likely than nondrinkers to die of provide to a limited group of people. It abuse on a regular basis in their suicide.12 would be irresponsible for the churches, missions, and benevolent Senator Thurmond also testified that government to allow a health-claims ministries. * * * Families have been the effects of alcohol consumption vary statement on alcoholic beverages that destroyed. Lives have been lost. Careers from individual to individual, and any urge the most risk laden way of have been ruined. Men and women have clarifying statement along those lines obtaining those benefits.’’ left the ministry as a direct result of would ‘‘have to address factors such as CSPI also suggested that there were alcohol abuse. Furthermore, alcohol is age, sex, family, medical history, diet, safer methods of reducing one’s risk of often a primary contributing component weight, and activity.’’ (April 25, 2000; heart disease, stating that the ‘‘discrete to poverty, forcing faith communities to Washington, DC, page 16). MADD noted category of people who may benefit use precious limited resources to assist ATF’s historic policy of requiring from moderate drinking could also the alcohol abuser as well as the balance in health claims, and suggested lower their risk of heart disease by other abuser’s intended or unintended that in ‘‘order to ‘appropriately qualify less risky alternatives, such as quitting victims.’’ (April 25, 2000; Washington, and balance’ the alleged health claim smoking, reducing fat in the diet, getting DC, page 151). benefits with the negative regular exercise, taking a daily low dose Ms. Suzanne Harrington-Cole, Chair consequences, the alcohol label would aspirin, or reducing stress. All of those of the Vallejo Alcohol Policy Coalition, have to be the size of a billboard and methods are much less likely to cause testified in favor of a complete ban on advertising messages would be longer accidents or other health problems than the use of health claims on alcohol than the State of the Union Address.’’ consuming alcohol, even in beverage containers. She stated that (Comment 20). Accordingly, MADD moderation.’’ (Comment 400). alcohol is present in more than 50% of suggested that to avoid misleading The Tangipahoa Alcohol and Drug all incidents of domestic violence (May consumers, such claims should be Abuse Council (Comment 24) noted that 24, 2000; San Francisco, CA, page 245), banned entirely. consumers often look for ‘‘the easy way and noted that ‘‘[w]e do not need a The United Communities Against out,’’ and that many may believe that government sanction on more drinking Drug & Alcohol Abuse commented that drinking alcohol will get the same in the name of health.’’ (Id. at page 243). ‘‘[n]o brief message on any beverage benefits as an overall healthy lifestyle. container can possibly provide a The Pacific Drug Policy Institute, Inc. 3. The Issue Is Too Complex To Be consumer with adequate information to commented that ‘‘smoking cessation, Summarized on an Alcohol Beverage make a decision about drinking ‘for good diet, exercise, and stress Label Because the Effects on Health of health-related reasons.’’’ Instead, they management techniques provide cardiac Alcohol Consumption Vary From suggested that in order to balance a benefits with much lower risk of Person to Person health message, ‘‘consumers would adverse consequences. When there are Many of the commenters stated that a need to be provided with a detailed low risk ways to attain the health summary statement of health benefits on multi-page document (similar to those benefits attributed to wine, it would an alcohol beverage label would mislead now provided by manufacturers of appear absurd to allow advertisement of consumers because the effects on health prescription medication) in order to medicinal value in high-risk alcohol of alcohol consumption vary from make [an] informed choice about consumption.’’ (Comment 34). person to person, based on various whether or not a decision to consume an Ted Miller, PhD, an economist, factors. These commenters also alcoholic-beverage for health reasons testified at the hearings that a more cost- suggested that the issue was too would be, on balance, a good or a bad effective way to obtain the purported complex to be summarized on an decision.’’ (Comment 31). The Marin benefits associated with consumption of alcohol beverage label, rendering all Institute (Comment 324) agreed, wine would be to walk a mile, drink a such labeling statements inherently commenting that ‘‘[d]etailed, balanced glass of juice, or eat one cup of misleading. Thus, the American Cancer and cautionary information about vegetables every day. (April 25, 2000; Society noted that the potential health potential harmful effects would be Washington, DC, pages 179–183). impact of alcohol consumption varied required (as it is with advertisements of 5. Health Claims and Health-Related from individual to individual, and that prescription drugs) in order to offset the Messages Would Be Misconstrued by a ‘‘brief message on any beverage demonstrated confusion of the general Consumers, Particularly Those With a container cannot provide a consumer public about the health effects of History of Alcoholism or Who Are with adequate information to make an alcohol. The volume of information Susceptible to Alcohol Abuse Problems, informed decision about drinking ‘for needed could hardly be legible if it were as an Endorsement To Consume or health related reasons.’’’ (Comment displayed on a bottle of wine or beer.’’ 527). Abuse Alcohol NCADD urged ATF to ‘‘prohibit labels 4. Even if Moderate Alcohol Many professionals in the field of and advertisements that make claims Consumption Is Linked to a Reduced addiction medicine commented that regarding potential health benefits Risk of Heart Disease, There Are Safer health claims and health-related associated with the consumption of Ways To Achieve the Same Reduction messages were likely to be alcoholic beverages, because it would be Without the Risks Associated With misinterpreted by those most impossible to adequately and Alcohol Consumption susceptible to problem drinking. Many appropriately convey the negative Many commenters suggested that of these commenters were particularly health consequences.’’ (Comment 15). even if alcohol consumption resulted in concerned with the risk that recovering NCADD noted that elderly consumers health benefits for certain individuals, alcoholics would use information about have special concerns, and that there were less risky ways to obtain the purported health benefits of alcohol NIAAA’s definition of moderate those benefits. For example, the Central consumption to justify their continued drinking for women and men over the Nebraska Council on Alcoholism, Inc. use of alcohol. For example, a physician age of 65 is no more than one drink a (Comment 14) noted that ‘‘[t]here are who has worked in the alcohol and day. They cited a study showing that simply less risky ways to attain the substance abuse treatment field for 18 among persons older than 65, moderate same health benefits that consuming years stated that any message about and heavy drinkers were 16 times more small amounts of alcoholic beverages purported health benefits sends the

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wrong message to the public, especially years, and is in the middle of ongoing consumers with useful information.’’ the alcohol abuser or alcoholic. He research on the perceptions of drinkers (Comment 388). expressed concern that such a message regarding moderate alcohol Two major associations representing ‘‘would only encourage the alcoholic to consumption. She noted that previous the wine industry also commented in drink more to ‘help his heart’’’ and studies had shown that perceptions of support of the substantive health claims feared that ‘‘many current alcoholics moderate drinking were clearly related provisions of the proposed rule. The who are in total recovery and abstinence to drinkers’ current drinking patterns Wine Institute commented ‘‘that the may use this as a justification to begin and their history of problems relating to public should receive the whole story drinking alcohol again, thinking they drinking. (May 23, 2000; San Francisco, regarding the responsible consumption can control it.’’ (Comment 381). Another page 37). of wine and applaud[ed] ATF’s efforts, doctor made a similar point, (Comment as reflected in the additional proposed B. Comments in Favor of Health Claims 385) as follows: regulation language, to refine and focus A few commenters specifically the conditions which must be met The American public has become accustomed to warning labels on harmful supported ATF’s proposal to allow before any substantive claim regarding products * * *. A label touting health qualified, detailed and balanced health health benefits can be made on wine benefits of use of alcoholic beverages in claims in the labeling and advertising of labels or in advertisements.’’ (Comment controlled and low amounts, is likely to be alcohol beverages. One comment, from 401). misinterpreted by problem drinkers, CEI and CA, specifically supported the The AVA also stated it had no especially by alcoholics, whose belief use of summary health claim statements objection to the proposed amendment to systems about their drinking distort reality without qualification or disclosure of the regulations to reflect current ATF with respect to the relative benefits and risks the adverse effects on health caused by policy, noting that ‘‘[a]s our members of consumption. * * * I do not deny the have been required to conform to these scientific validity of reports of health benefits alcohol consumption. Finally, of consumption of one glass of wine per day approximately 45 commenters policies for some years, converting them for females or two glasses of wine per day for supported the general use of health to regulation would pose no further males. However, the risk of misinterpretation claims with respect to alcohol hardship.’’ (Comment 417). by the drinking public is far greater than any beverages. A comment from the Washington public health or public information benefit Legal Foundation (WLF) focused that may be alleged to accrue from adding 1. Comments in Favor of Allowing primarily on legal issues, noting that if labels to products that promote health Balanced Health Claims, as Set Forth in the rule was properly implemented, it benefits from drinking. the Proposed Rule would pass muster under the First The National Association for Children The comments in favor of the Amendment. (Comment 390). This of Alcoholics (Comment 29) also substantive health claim provisions of comment will be discussed further suggested that health claims can lead to the proposed rule generally stated that under section XIX. confusion among children of alcoholics ATF had struck an appropriate balance 2. Comment Supporting Summary about the role of alcohol, and can in dealing with a difficult issue. For reinforce and perpetuate the denial Health Claims Without Qualification or example, the National Consumers Disclosure of Adverse Effects process of the alcohol-addicted person. League (NCL), a national nonprofit Only CEI and CA specifically argued 6. The Use of the Term ‘‘Moderate’’ in consumer advocacy organization that was founded in 1899 to represent in favor of allowing summary health a Specific Health Claim Would Be claims without qualification or Misleading Unless the Term Is Defined consumers in the marketplace and workplace, recognized the difficult disclosure of adverse effects in the Many public health organizations nature of the issue as follows: labeling and advertising of alcohol commented that the use of the term beverages. CEI and CA opposed ATF’s ‘‘moderate’’ in a health claim could NCL believes that the proposed rule raises notice on the grounds that it would a serious public policy question for which mislead consumers who did not there is no easy answer. NCL understands serve to suppress truthful and non- understand the definition of the term. ATF’s concern as to whether health claims misleading speech. (Comment 326). CEI The United Communities Against Drug should be permitted on alcoholic beverages and CA argued that the cardiovascular & Alcohol Abuse noted that ‘‘moderate’’ at all. While there is a body of research and overall health benefits associated drinking was poorly defined. It noted showing that moderate consumption of with moderate alcohol consumption are that the Substance Abuse and Mental alcohol reduces the risk of coronary heart amply supported by the medical Health Services Administration disease (CHD), there is also evidence that evidence, and summary statements of (SAMSHA) study showed that ‘‘virtually moderate drinking may increase the risk of these benefits are protected by the First certain cancers. Moreover, as ATF notes, all drinkers define their personal level moderate drinking is risky for certain Amendment. of consumption as ‘moderate,’ whether individuals who are prone to alcoholism, CEI and CA suggested that those they consume one drink per week or some of whom may not realize that they are. individuals who would not benefit from five per day.’’ (Comment 31). CSPI also Excessive alcohol consumption is moderate drinking ‘‘know who they are noted that consumers had varying unquestionably harmful. Whether a properly and are unlikely to be misled.’’ CEI and definitions of the term ‘‘moderate.’’ qualified health claim should be permitted CA also suggested that the CSAP survey (Comment 400). Rather than on alcoholic beverage labels is a serious supports a conclusion that consumers recommending moderate consumption, policy question that has been debated by would not be misled by directional CSPI suggested that any health claims public health experts for years. statements, that such statements would should provide specific quantities of NCL concluded that while it ‘‘has not change the drinking patterns of alcohol that constitute moderate reservations about authorizing any consumers, and that the population consumption, including a health claim for alcoholic beverages, we studied understands the risks of recommendation that consumers drink believe a properly qualified and drinking, particularly that drinking is no more than one drink per day. balanced claim would be of value to counter-indicated during pregnancy. Nancy Piotrowski, PhD, testified that many consumers. * * * A healthclaim CEI and CA claimed that other she had been conducting research on that includes the elements specified in Federal agencies have approved alcohol consumption for the past 16 the proposed rule would provide these summary health statements without the

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extensive qualifications that would be meant to support directional statements or disclosure of adverse effects. The required under ATF’s proposed rule. As only or whether they specifically First Amendment issues raised by these examples, they pointed to health claims supported the use of substantive health commenters will be addressed approved by FDA for diets low in claims on labels or in advertisements. separately in section XIX. saturated fat and cholesterol and diets Most of the comments that favored a Among the medical experts who low in sodium. They also suggested that rule allowing the use of substantive testified at the hearings in favor of the ‘‘balance’’ ATF is ostensibly seeking health claims reflected a general allowing health claims or health-related would automatically be provided by the perception that consumers were entitled statements on labels or in mandatory health warning statement on to information about potential health advertisements, some specifically noted alcohol beverage containers. benefits associated with moderate that consumers should be made aware The CEI and CA comment suggested alcohol consumption. For example, one of both the risks and purported benefits that the proposed rule would result in individual suggested that ‘‘consumers of moderate alcohol consumption. For regulations that violated the First have the right to know and can be example, Dr. Ellison suggested that an Amendment; thus, the proposed rule trusted to handle this scientific appropriate message on a label would be should be withdrawn. At the public information.’’ (Comment 300). Another ‘‘ ‘[w]hile light to moderate alcohol hearing, Mr. Ben Lieberman testified on comment supported ‘‘the rights of consumption can be consistent with a behalf of CEI and stated that CEI wineries to list the health benefits of healthy lifestyle for most individuals believed that the rulemaking should their product on the labels.’’ (Comment and has been shown to dramatically result in a ‘‘policy allowing a wide 277). reduce the risk of heart disease, certain range of accurate summary statements Some of the individuals commenting individuals should not drink at all.’ about moderate drinking and health to in favor of health claims specifically Then, you should go through the list of appear on alcoholic beverage labels and supported the concept that the claims be the people that we are advising not to ads.’’ (April 25, 2000; Washington, DC, balanced, although it was unclear drink.’’ (April 26, 2000; Washington, page 119). Mr. Lieberman also suggested whether they were suggesting that the DC, page 116). that ATF had not accurately balance would come from qualifications Finally, Mr. John Hinman testified on summarized the evidence demonstrating in the claims or the required behalf of the American Wine Alliance the health benefits associated with Government warning statement. For for Research and Education as well as moderate alcohol consumption, but example, one individual stated that ‘‘[i]t the Coalition for Truth and Balance, a instead spent ‘‘much of its time is only fair and proper that the labels on group of California wineries. Mr. identifying and somewhat exaggerating the bottle contain the positive health Hinman suggested that it was the every conceivable category of individual benefits as well as the proper health Government warning statement, rather who is not likely to benefit from warnings.’’ (Comment 143). Another than the directional statements, which moderate drinking, such as adults too commenter expressed his support for misled consumers about the health young to be at risk for heart disease, ‘‘producers of wine to be able to print consequences of alcohol consumption. pregnant women, and recovering both the adverse and the positive effects (May 23, 2000; San Francisco, CA, page alcoholics.’’ (Id. at page 120). of consuming wine.’’ (Comment 340). 149). Mr. Hinman was also one of the In response to a question from the Many of the commenters suggested few individuals responding to ATF’s panel, Mr. Lieberman confirmed that it that consumers need to be made aware question about whether it was possible was CEI’s belief that a health claim of health-related information, including to craft a balanced substantive health regarding cardiovascular benefits, such the positive and negative effects of claim. He noted that he had submitted as ‘‘there is significant evidence that alcohol consumption, in order to make a 664-word statement to ATF for review moderate consumption of alcoholic informed decisions regarding its use. in 1993, entitled ‘‘Wine and Health— beverages may reduce the risk of For example, one commenter, a Behind the French Paradox.’’ (Id. at cardiovascular disease,’’ could appear psychologist and attorney, stated that it page 151). Mr. Hinman stated that on a label with no disclaimer and still was ‘‘necessary to rationally accept that ‘‘considering that 664 words makes for not mislead consumers. He stated that alcohol has benefits as well as dangers a very wordy wine label, we seriously ‘‘it is well known that people * * *. Since Americans can easily and doubt whether any wine maker really understand the limitations of legally drink, and most in fact do so, the has an interest in providing such a advertising and labeling and that they need to inform them of the range of statement on the bottle. However, the would be skeptical. They would also drinking consequences and the related statement can and should be available to read the government warning, which drinking limits for each is both prudent hand out to those customers who does at least allude to the other side of and democratic.’’ (Comment 243). A request more information or are this story.’’ (April 25, 2000; Washington, doctor commented as follows: interested in the subject matter.’’ (Id. at DC, pages 133–134). It makes more sense to put more page 152). Accordingly, Mr. Hinman stated he was resubmitting the 3. Other Comments in Favor of Health information on the label in order for the consumer to make a better decision. As a statement to ATF for review, and later Claims physician, I implore my patients to read clarified in response to a question from Approximately 45 comments labels. There are certainly some potential the panel that he would put the supported the use of substantive health health benefits to wine as well as potential statement on an application for label claims in the labeling and advertising of downsides in individuals. (Comment 145). approval. (Id. at pages 152, 165). alcohol beverages. However, these Two commenters argued that alcohol In response to a question from the commenters did not specifically support producers have a First Amendment right panel, Mr. Hinman stated that neither the type of summary health claim to market the health benefits of alcohol the American Wine Alliance nor the advocated by CEI and CA. Instead, they consumption, provided that such Coalition for Truth and Balance was commented in favor of the general information is presented in a non- ‘‘interested, to my knowledge, in principle that health claims for alcohol misleading manner. However, neither of necessarily using CEI’s proposed label. beverages are not inherently misleading. these comments suggested that industry * * * On the other hand, as a lawyer In some cases, it was difficult to members were entitled to use summary * * * that’s an absolutely accurate determine whether these commenters health claims without any qualification statement that CEI is using on that

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particular thing, and I would support In consideration of these comments, with various levels of alcohol their First Amendment right to utilize it. the final rule specifically provides that consumption. It’s going to be up to them to find people a claim will not be approved unless it Accordingly, the final rule provides that are, in fact, going to use it.’’ (Id. at is sufficiently detailed and qualified that a specific health claim must page 167). with respect to the categories of adequately disclose the health risks individuals to whom the claim applies. associated with both moderate and C. Decision For example, assuming that the heavier levels of alcohol consumption. After careful consideration of the evidence continues to indicate that the It is misleading to imply that moderate record, TTB finds that the comments potential health benefits associated with alcohol consumption confers only and testimony on this issue establish moderate alcohol consumption are health benefits; the administrative that the use of health claims in the mainly associated with men over age 45 record establishes that there are labeling or advertising of alcohol and women over age 55, then the claim significant risks associated with beverages has the potential to mislead would have to specifically set forth this moderate consumption, including an consumers as to the very serious health qualification. Furthermore, the concerns increased risk of certain cancers. Even if consequences associated with alcohol expressed in the comments regarding a claim is made regarding only moderate abuse and consumption. In particular, the definition of the term ‘‘moderate’’ consumption, consumers should be TTB finds that the rulemaking record would also be addressed by requiring, advised of the health risks of heavier overwhelmingly supports the where necessary, sufficient detail in the levels of alcohol consumption. The conclusion that the type of detail, claim itself regarding the meaning of record reveals that a high percentage of qualification, and balance required by this term. This level of detail could the alcohol consumed in this country is the proposed rule would be necessary to include specific information as to what consumed at levels that exceed avoid misleading consumers about the constitutes ‘‘moderate’’ levels of ‘‘moderate drinking.’’ The Marin serious health risks associated with consumption, possibly including Institute comment states that alcohol is alcohol consumption. separate definitions for men, women, consumed at heavy levels (3 or more Based on the comments on this issue, and the elderly. drinks per day, or more than 5 drinks however, TTB is adopting certain Many commenters suggested that at one time) in 78 percent of all drinking changes to the final rule to set forth there are safer ways to reduce the risk occasions. (Comment 324). Furthermore, more specifically how a substantive of heart disease without the negative Dr. Criqui testified that half of all the health claim would comply with the health consequences associated with alcohol consumed in the United States requirements of the regulation. For alcohol consumption. Again, this is a is consumed by the 10% of men and the example, TTB agrees with the NCADD point noted in the 2000 Dietary 5% of women who are alcohol- comment that it has not been proven Guidelines, which remind consumers dependent. (May 23, 2000; San that alcohol itself lowers the risk of that ‘‘there are other factors that reduce Francisco, CA, page 57). Finally, a study heart disease in certain people; this the risk of heart disease, including a submitted by CEI and CA noted that comment is consistent with the 1999 healthy diet, physical activity, ‘‘[i]n the United States, less than 10% of ‘‘Alcohol Alert’’ published by NIAAA. avoidance of smoking, and maintenance the population reports drinking more The 2000 Dietary Guidelines state only of a healthy weight.’’ In reviewing than two drinks per day, the cutoff for that ‘‘[d]rinking in moderation may whether a health claim tends to mislead ‘heavy drinking’ in national survey lower risk for coronary heart disease, consumers, TTB will certainly consider research. This means that ‘moderate’ mainly among men over age 45 and whether the health claim misstates the drinkers, because of their much greater women over age 55.’’ The final rule role played by these factors in reducing numbers, probably account for well over provides that a specific health claim one’s risk of heart disease. half of all alcohol problems, a finding would not be approved unless it is Several commenters suggested that that led researchers at the Institute of truthful and adequately substantiated by any health claim might be Medicine to observe in a scientific or medical evidence. Thus, misinterpreted by alcoholics and other groundbreaking report that ‘if all the TTB would not approve any claim abusers of alcohol as a rationalization clinically diagnosed alcoholics were to implying that alcohol consumption for their own consumption levels. TTB stop drinking tomorrow, a substantial itself caused a reduced risk of heart recognizes the possibility that certain fraction of what we understand as disease in the absence of scientific or consumers will selectively interpret alcohol problems would still medical evidence substantiating such a data regarding the health consequences remain.’’’13 These statistics make it claim. of alcohol consumption to justify their clear that a specific health claim touting TTB also agrees with those own behavior. We believe that summary the potential health benefits of moderate commenters who suggested that the health benefit claims that do not alcohol consumption would be effects on health of alcohol disclose the adverse health misleading without a referral to the consumption vary from person to consequences of alcohol consumption health risks associated with both person, and that any labeling or would be particularly susceptible to this moderate and higher levels of alcohol advertising statement that failed to take type of misinterpretation. We recognize consumption. this into account would mislead the possibility that certain abusers of In addition, the administrative record consumers. Consistent with the 2000 alcohol may use information regarding establishes that there are certain Dietary Guidelines, many commenters the potential cardiovascular benefits of categories of individuals for whom any noted that moderate consumption alcohol consumption to justify alcohol alcohol consumption at all is not provided little, if any, health benefit for abuse that clearly poses significant recommended. Accordingly, the final younger people, who are at low risk of health risks. However, it is our rule provides that any specific health heart disease. As noted above, the conclusion that the best way to prevent claim must outline the categories of Dietary Guidelines provide that this type of misinterpretation of a health individuals for whom any levels of ‘‘[d]rinking in moderation may lower claim, by both alcohol abusers as well alcohol consumption may cause health risk for coronary heart disease, mainly as consumers who do not abuse alcohol, risks. The Beer Institute commented that among men over age 45 and women is to require detailed information ATF’s proposed standard on this issue over age 55.’’ regarding the health risks associated made it unclear whether ‘‘disclaimers

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are required only for categories of overview of the benefits and risks proposed by CEI would mislead individuals whose potential negative associated with alcohol consumption. If consumers by not disclosing the health effects are literally numerous or the regulations imposed a complete ban significant adverse effects on health whether the potential negative health on advertising materials that included associated with alcohol consumption, effects would be aggregated for the health-related statements, then industry which are set forth in great detail in this purposes of performing the balancing members would no longer be allowed to rulemaking record. test envisioned by the proposed include this NIAAA publication in TTB has not drafted a model health regulation.’’ (Comment 396). advertising materials. Yet TTB finds claim for use on alcohol beverage labels Accordingly, the final rule clarifies that nothing in the record to establish that because this extensive rulemaking this requirement is intended to cover the inclusion of this type of record has revealed little, if any, interest the categories of individuals for whom comprehensive discussion of effects on on the part of industry members in alcohol consumption is not health in an advertisement in any way using substantive health claims on recommended (e.g., pregnant women, misleads consumers as to the health alcohol beverage labels. In fact, industry individuals taking certain medications, risks of alcohol consumption. members not only failed to express such etc.). Accordingly, we find that the record an interest, in many cases, they We do not agree with CEI and CA that does not support an overall ban on the specifically disavowed any interest in it is unnecessary to set forth this use of specific health claims and health- using substantive health claims. information in conjunction with a related statements in the advertising of Furthermore, as discussed further in health claim because these people know alcohol beverages. section XVIII, any such claim might who they are. For example, it is not at A closer issue is presented by the well subject the product to regulation as all clear that most consumers know that labeling of alcohol beverages. As ATF a drug under FDA regulations. alcohol can interact harmfully with a noted in Industry Circular 93–8, we Accordingly, TTB will leave it to any variety of prescription and over-the- believe that it would be difficult to interested industry members to seek counter medications. It is TTB’s compose a health claim that is detailed approval of a substantive health claim conclusion that any labeling or and specific enough to meet our through the label approval process. The advertising statement that makes a standards, yet short enough to fit on a final rule sets forth the standards that substantive health claim regarding traditional alcohol beverage label. In would apply to any such labeling alcohol consumption would mislead addition, TTB will not approve any statement. If an industry member wishes consumers if it does not set forth this labeling health claim that contradicts to use a substantive health claim on a important information about the adverse the message of the required Government label in compliance with the standards consequences of alcohol consumption. warning statement. set forth in the final rule, it should Notwithstanding the above, we find that TTB agrees with the commenters who apply for a certificate of label approval. the rulemaking record does not support suggested that a summary substantive ATF announced in Industry Circular a conclusion that health claims in the health claim which does not include 93–8 that dissemination of the full text labeling and advertising of alcohol sufficient detail and qualification would of the April 1992 edition of ‘‘Alcohol beverages are inherently misleading. mislead consumers about the serious Alert’’ as published by NIAAA, would Nor does the record support a health consequences of alcohol not be in violation of the regulations. conclusion that the potentially consumption. However, we do not The final rule does not change this misleading nature of such claims cannot believe that this provides a basis for policy. Furthermore, dissemination of be cured with the appropriate use of banning all substantive health claims on the entire Dietary Guidelines as disclaimers and qualifying statements. alcohol beverage labels. Instead, as set advertising materials by industry Initially, it should be noted that none forth above, TTB is making changes to members, or dissemination of the two of the commenters who supported a the final rule to clearly provide that a pages from the current Guidelines total ban on the use of health claims in specific health claim will not be dealing with alcohol beverages (pages the labeling and marketing of alcohol allowed unless it is truthful and 36 and 37) would not violate the final beverages presented consumer data on adequately substantiated by scientific or rule. Both of these materials provide a the use of substantive health claims in medical evidence; sufficiently detailed comprehensive discussion of the health the labeling or advertising of alcohol and qualified with respect to the consequences of alcohol consumption. beverages. Thus, we have no consumer categories of individuals to whom the The information in these materials data establishing that consumers would claim applies; adequately discloses the regarding the health consequences of be misled by the use of properly health risks associated with both alcohol consumption is truthful and qualified health claims that are moderate and heavier levels of alcohol supported by scientific evidence. The sufficiently detailed and specific, and consumption; and outlines the information is sufficiently detailed, which disclose the adverse health categories of individuals for whom any qualified and specific, and sets forth the consequences of alcohol consumption. levels of alcohol consumption may health risks associated with both A complete ban on the use of health cause health risks. moderate and heavier levels of alcohol claims or health-related statements in We disagree with the arguments made consumption. Both of these publications the labeling and advertising of alcohol by CEI and CA, the only commenters further set forth the categories of beverages would prohibit even the most who specifically favored allowing individuals for whom any level of qualified, detailed, and balanced industry members to make summary alcohol consumption may pose health discussion of health consequences in statements regarding health benefits that risks. Accordingly, these materials advertising materials. For example, in contained no qualification, balance, or comply with the standards set forth in Industry Circular 93–8, ATF advised disclosure of adverse effects. In the first the regulations. industry members that the regulations place, the record did not establish that As ATF stated in Industry Circular did not prohibit them from including there was any concrete interest on the 93–8, we will continue to evaluate any the entire text of NIAAA’s April 1992 part of the alcohol beverage industry in additional text that accompanies these edition of ‘‘Alcohol Alert’’ in using the summary health claim materials, such as editorializing, advertising materials. This NIAAA proposed in the CEI petition. Secondly, advertising slogans, or exhortations to publication presents a comprehensive we find that statements such as the one consume the product, to determine

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whether or not the advertisement as a directional statements, with an going to lead to a cascade of criticism’’ whole presents truthful and non- additional 3.9% indicating they would and that the phrase ‘‘health effects’’ misleading information regarding the drink less. came from the Appropriations risks associated with alcohol In response to ATF’s question of Committee’s language in appropriating consumption. Furthermore, the use of whether the negative consequences of funds for NIH and NIAAA to research any buttons, shelf talkers, table tents, alcohol consumption and abuse the effects on health of moderate and similar items that excerpt any disqualified alcohol beverages from drinking. (Id. at page 40). portion of the NIAAA publication or the entitlement to health claims or health- When asked about consumer reaction Dietary Guidelines, or that are based on related statements, the Wine Institute to the directional statements, Mr. any other publication or article about submitted extensive summaries of DeLuca noted that only 17 companies the health consequences of alcohol scientific studies on moderate had received approval from ATF for consumption, will be closely consumption of wine and alcohol for using directional statements before the scrutinized to determine if they tend to the Dietary Guidelines Review Process. moratorium went into effect—5 received mislead consumers about the serious An updated compilation of that approval for the Dietary Guidelines risks associated with alcohol submission was attached to their statement, and 12 utilized the family consumption. comment. The Wine Institute stated that doctor statement. (May 23, 2000; San it ‘‘fully subscribes to an open and Francisco, CA, pages 14–15). Mr. XVI. Are Health-Related Directional vigorous dialogue driven by the findings Statements Misleading? DeLuca stressed that the Wine Institute of the scientific community on the did not encourage wineries to use the As previously noted, the vast majority health effects of alcohol consumption.’’ label, noting that ‘‘[w]e always thought of the commenters addressed the issue The Wine Institute submitted a of this as a voluntary option for our of health-related directional statements, supplemental comment in which it members. They were designed primarily such as the ones approved by ATF in stated that it wished ‘‘to underscore for public policy, not for public 1999, rather than the issue of how critical it is to make the distinction relations, a distinction with an substantive health claims. between health-related statements and enormous difference.’’ (Id. at 15). those in which a substantive claim of Approximately 355 commenters The AVA, a trade association of health benefits is advanced. A expressed support for the use of American wineries representing substantial number of submissions you directional statements on alcohol approximately 600 members, also noted beverage labels. Many commenters have received to date appear to blur this crucial difference and argue against that it had been involved on behalf of stated that directional statements are not one of its members in the ATF review substantive health claims and that they directional labels by incorrectly classifying such labels as health process for the directional statements merely refer consumers to other sources approved in 1999. (Comment 417). AVA for information about the effects on claims.’’ (Comment 401b). Mr. John DeLuca, President and CEO stated that it agreed with the applicant, health of alcohol consumption. As such, Mr. Patrick Campbell, that the the commenters maintain that of the Wine Institute, testified at both the Washington, DC and San Francisco, directional statement ‘‘makes no claim, directional statements are not pro or con, therapeutic or curative, true misleading to consumers. On the other California hearings. Mr. DeLuca stated that he believed that wineries have a or false. The COLA [certificate of label hand, most of the approximately 120 approval] makes no claim at all. It comments in opposition to the use of First Amendment right to use the directional label, and pointed to the merely (and sensibly) encourages health claims also opposed the use of consumers to consult with their family health-related directional statements in CSAP survey as evidence that consumers would not increase doctor about their personal use of the the labeling and advertising of alcohol product. * * * Since this COLA makes beverages. consumption as a result of directional statements. (April 25, 2000; no claim, questions about its potential A. Comments and Testimony in Favor of Washington, DC, page 32). He urged the to mislead are irrelevant.’’ (Comment the Use of Health-Related Directional empowerment of the public through 417). The President of AVA, Mr. Simon Statements dissemination of information, and urged Siegl, testified at the public hearings in Most of the comments in support of that the public should be trusted ‘‘to support of a winery’s right to use a directional statements shared the view handle this information.’’ (Id. at pages directional label. (April 26, 2000; set forth in the Wine Institute’s 32–33). Washington, DC, page 65). comment as follows: When asked about substantive health Many winemakers also commented in claims, Mr. DeLuca stated that ‘‘we are support of the use of directional Directing consumers to consult with their not trying to sell wine as health food or statements. Some emphasized the doctors or to refer to the Dietary Guidelines regarding the health effects of wine as a medicine.’’ (Id. at page 37). He said neutral content of the directional consumption constitutes a responsible and that ‘‘we should be erring on the side of statements. The Associated Vintage neutral message. Far from misleading the making it as hard as possible for Group asked ‘‘what can be a better public, such statements are designed to someone to make a health claim. It message than referring them educate and empower each individual to really is not the province of the industry [consumers] to our own government’s make fully informed choices regarding the to be talking that way. We want third- nutritional guides or, even better, consumption of wine. (Comment 401). party peer review journals research to be checking with their doctors.’’ (Comment The Wine Institute’s comment also what is presented to the public, not 173). Mr. Kent Rosenblum commented stated that health-related directional what we put to the public.’’ (Id. at page that ‘‘[d]irectional labels do not statements were ‘‘certainly not 38). In response to a question about constitute health claims, and misleading because they do not whether the directional statements were government survey data indicate no constitute substantive health claims in perceived as health claims, Mr. DeLuca changes in drinking patterns would the first instance.’’ They cited the CSAP stated that the Wine Institute had occur.’’ (Comment 151). He then went survey, which concluded that the withdrawn its original label submission, on to note that ‘‘[t]here is a developing drinking patterns of 88.3% of the which included the phrase ‘‘health scientific consensus that moderate wine participants would not be influenced by benefits,’’ because they ‘‘knew it was and alcohol consumption can be part of

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a healthy diet and lifestyle for those positive health-related statements were consumption. (April 26, 2000; who choose to drink.’’ necessary to ‘‘balance’’ the negative Washington, DC, pages 30–33). Mr. Other wineries specifically referenced information provided by the George Linn, a consumer, also testified the directional statements as providing Government warning statement. For in support of the concept of referring balance to the Government warning example, one commenter supported the consumers to their physicians for more statement, or referring to the ‘‘benefits’’ directional statements because the individualized advice about alcohol of consumption. For example, De Rose warning statement should be consumption. (May 24, 2000; San Vineyards commented that ‘‘[t]he U.S. supplemented with ‘‘equally valid’’ Francisco, CA, page 256). On the other Dietary Guidelines for Americans information ‘‘explaining the benefits hand, Dr. Paul Scholten, an associate constitutes a responsible and neutral and positive effects of responsible professor of obstetrics, gynecology, message.’’ The winery also stated that consumption.’’ (Comment 296). Another reproductive medicine, and nursing, ‘‘[t]here is a very substantial body of individual supported the use of testified in support of the directional scientific data that verifies the efficacy ‘‘positive health related statements’’ and statement referring consumers to the and healthfulness of moderate wine stated that ‘‘[t]he wine industry deserves Dietary Guidelines, but expressed consumption. Withholding this most to be afforded an opportunity to address concerns about whether doctors were helpful and beneficial information, and the latest beneficial health aspects of well trained to advise patients about the instead only emphasizing the harmful moderate wine consumption, as health consequences of alcohol effects of wine consumption, is outlined in the U.S. dietary guidelines, consumption. (May 23, 2000; San ludicrous and ultimately destructive on its products. The entire thrust of Francisco, CA, pages 170–171). and irresponsible. A forthright balance Government Warning labels has been Some individuals commented in of both positive and negative simply entirely negative.’’ (Comment 240). support of the general concept of educates an informed public and allows Finally, some commenters argued that directional statements. Dr. Dwight them to make responsible decisions.’’ the Government should encourage Heath, a Professor of Anthropology, (Comment 172). Two other wine consumers to seek the best advice testified that while he opposed the use producers made similar comments possible from the most credible sources of substantive health claims, he favored (Comments 214 and 387). available on any health issue. With the use of the directional statements on Many commenters who did not respect to the consumption of alcohol labels. (April 26, 2000; Washington, DC, identify themselves as being part of the beverages, the National Association of page 13). Dr. Heath suggested that the wine industry also supported the Beverage Retailers suggested that more people know about alcohol directional statements. Some supported ‘‘[p]hysicians and the U.S. Dietary consumption, the less likely they are to the general concept of directing Guidelines are among the most credible have alcohol-related problems. (Id. at consumers to the Dietary Guidelines or sources available to give professional, page 5). Similarly, Professor R.L. their physician for more information objective, responsible and balanced Williams, of the Oenological Research about the effects on health of alcohol advice on an important health issue.’’ Facility of Old Dominion University, consumption. One suggested that ‘‘[t]he (Comment 424). stated that in his opinion, ‘‘the level of wording is neutral and not positive, At the hearings, several doctors scientific information regarding the thereby serving as education rather than testified in support of the directional positive health effects of moderate propaganda.’’ (Comment 332). Several labeling statements. Some specifically consumption of wine is now quite commenters referred to the consumer supported the statement encouraging overwhelming. * * * This information survey conducted by CSAP as evidence consumers to consult with their should be made more available to the that the statements did not mislead physician. For example, Dr. Michael consumers in regard to the directional consumers. Apstein, a gastroenterologist and liver health statements.’’ (April 26, 2000; Some commenters argued that doctor, testified that advice regarding Washington, DC, page 91). Mr. Archie consumers have a right to know all the alcohol consumption should be targeted Brodsky, a senior research associate in scientific information available on both to specific populations rather than psychiatry and the law, testified in favor the positive and negative effects of generalized for the entire population. He of the use of directional statements on various levels of alcohol consumption, stated that ‘‘[t]hese are complex issues alcohol beverage labels. He stated that and that such information allows that can’t easily be summarized on a the CSAP survey confirmed that the consumers to make informed decisions label that goes on a wine bottle. They labels would have a ‘‘negligible’’ regarding alcohol consumption. For need to be discussed with a person’s influence on consumers’’ drinking example, one commenter stated that physician and individualized to that habits. (April 26, 2000; Washington, DC, ‘‘people are generally capable of making person’s situation. Therefore, I am in page 171). sensible decisions, if assisted by favor of a directional label that advises Mr. Patrick Campbell of Laurel Glen complete information. * * * Moreover, individuals to discuss this topic with Winery, who submitted the first the small minority who do not make their physicians, because I am hopeful directional statement to ATF for sensible decisions will not be deterred that a directional label will stimulate approval in 1995, testified on behalf of by suppressing the presentation of another kind of educational experience, the Coalition for Truth and Balance. Mr. accurate, balanced information.’’ so people can use alcohol responsibly if Campbell stated that discussion of the (Comment 423). An individual they so desire and avoid it if they health benefits or risks of alcohol suggested that ‘‘in an era when we all should be avoiding it.’’ (April 25, 2000; consumption was not relevant to a are trying to eliminate governmental Washington, DC, page 167). discussion of the directional statements, control of those areas of our lives where Similarly, Dr. Harvey Finkel, a since ‘‘the approved messages do not we can be treated as adults, it seems odd physician and clinical professor of constitute health-related statements or for you to be against a neutral statement medicine, testified that both directional make substantive claims regarding that wine drinkers should consult their statements should be allowed, stressing health benefits.’’ (May 23, 2000; San doctors about the possible health the importance of advising consumers to Francisco, CA, page 75). He asserted benefits of wine.’’ (Comment 136). consult their doctors, because the public that the message encouraging consumers Many of the commenters suggested has a right to be fully informed about to consult with their family doctors ‘‘is that the directional statements or other the health consequences of alcohol neither true nor false. It makes no claim

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* * * positive or negative, therapeutic or physician about the choices they make B. Comments and Testimony in curative, pro or con.’’ (Id. at 76). Mr. in that regard.’’ (May 24, 2000; San Opposition to Directional Statements Campbell argued that the message was Francisco, California, page 200). In Public health organizations and other not misleading in that it ‘‘presumes response to a question from the panel, commenters raised the following nothing. It presupposes nothing. It in no Mr. Stuart suggested that ‘‘to have a specific objections to the use of way directs the outcome of any balanced message, to me the ideal directional health-related statements in consultation the consumer may or may would be to somehow combine both the the labeling and advertising of alcohol not undertake with his or her family warning and the directional message.’’ beverages. physician. For all the winery knows, the (Id. at page 210). doctor might tell all of his or her 1. Directional Statements Are Implicit Mr. Mark Chandler, the Executive patients never to touch the stuff * * *. Health Claims That Reinforce the Director of the Lodi-Woodbridge It’s a thoroughly neutral and impartial Inaccurate Perceptions of Consumers Winegrape Commission, also testified in message.’’ (Id. at 76–77). About Alcohol and Health Mr. Campbell expressed surprise at favor of the directional statements. He stated that ‘‘[g]rowers and wineries have CSPI commented that the directional the controversy over the message, and statements were actually implied health said he would have expected that no intention to market their products as claims. Its comment argued that the ‘‘every health professional and health food. But, unlike other food ‘‘reference to the ’health effects of wine governmental agency in the country products, we are prevented by consumption’ offers no useful would welcome it. * * * After all, if regulation from even mentioning our information, but simply reinforces you can’t trust your family doctor for product’s positive health attributes, thus existing inaccurate knowledge about the truthful and not misleading advice on the need for directional labels.’’ (May health benefits of alcohol consumption, health issues who can you trust?’’ (Id. at 24, 2000; San Francisco, CA, page 250). as spread through the media and the 78). Mr. Campbell noted that the Mr. Gordon Murchie testified on behalf wine industry’s misleading publicity American Heart Association ‘‘publishes of the Virginia Wineries Association in campaign, and implies that those a section on alcohol in their dietary favor of the use of directional guidelines that explicitly recommends statements, calling them public service benefits are substantial and universal.’’ that patients consult with their personal announcements that ‘‘direct the (Comment 400). physician on questions of alcohol use concerned citizen to another source of The American Cancer Society noted ***.’’ (Id. at 80). professional non-biased, balanced that ‘‘[w]ith the publicity in the past few Mr. Campbell stated that on June 3, information.’’ (April 26, 2000; years about the health benefits of 1999, before the moratorium on Washington, DC, page 78). In response consuming alcoholic beverages, any approving directional statements went to a question from the panel, Mr. less-detailed claim or reference to health into effect, ATF approved a version of Murchie said his members would be impacts or benefits might be interpreted the directional statement which omitted interested in using directional by the uninformed consumer as a the language about ‘‘the proud people statements on labels, but were reluctant suggestion that people should drink who made this wine’’ and instead read to do so until they saw that the alcohol for their health. Sufficient as follows: ‘‘We encourage you to statements were accepted by the information is needed to allow consult with your family doctor about Government and the public. (Id. at pages consumers to make a well-educated the health effects of wine 86–87). decision regarding their risk from consumption of this product.’’ consumption.’’ (Id. at page 74). He Dr. Ellen Mack, a physician and part stated that he now preferred this (Comment 527). Accordingly, the owner of a winery, testified that ‘‘[i]f American Cancer Society concluded version, since he believes that it fits wine were considered a medication— better in the label, it’s not pompous, and that directional labels ‘‘may mislead the and I’m not at all advocating that it general public regarding the health it was an appropriate response to the should be—it would be like most other people who argued that the ‘‘proud benefits of alcohol consumption by medications, the dose is critical. Too people’’ language constituted an providing inadequate information little may not have the desired effect, implicit endorsement of alcohol regarding the risks.’’ and too much can be dangerous or even consumption. (Id. at page 87). Senator Thurmond commented that In response to a question from the deadly.’’ (May 23, 2000; San Francisco, the directional statements were panel, Mr. Campbell stated that he had CA, page 132). Dr. Mack suggested that inherently misleading. He stated that it gotten no feedback from consumers as to ‘‘the directional wine labels are effective was unlikely that consumers who read how they viewed the directional agents in that the sources of the directional statements would statements. He said that ‘‘[n]obody’s information—the U.S. Dietary actually send for the Dietary Guidelines said anything, it’s unbelievable. I mean, Guidelines and personal physicians— or consult their physicians. Instead, it cost a lot of money to put these on the will clearly make the point that the Senator Thurmond suggested that label.’’ (Id. at page 88). beneficial health effects result from ‘‘consumers may be left with the Mr. Jack Stuart testified on behalf of moderate consumption of alcohol, and impression that these statements refer to the Napa Valley Vintners Association. these sources will define moderate as no studies that suggest drinking alcohol He stated that ‘‘we think that the more than one drink per day for women may have some positive health directional warning is a good thing. We and no more than two drinks per day for benefits.’’ He noted that ‘‘[t]his don’t consider it to be a positive health men.’’ Id. impression may reinforce inaccurate claim. If you take out the phrase ’proud Various other individuals testified in assertions about the health benefits of people,’ certainly it’s a neutral favor of the directional statement. For alcohol consumption spread through the statement, it’s simply a way of getting example, Ms. Annette Shafer, author of media. These statements may also be information, and we think it’s a good ‘‘The Wine Sense Diet’’ testified in favor inappropriately viewed as the idea for anyone who is proposing to of a ‘‘more balanced message on the government’s endorsement of drinking. drink, or who does drink, or who does bottle,’’ suggesting that the warning However, any suggestion that the any other thing having to do with food, label is ‘‘very one-sided.’’ (May 24, government endorses drinking for their diet, their lifestyle, to consult their 2000; San Francisco, CA, page 212). health reasons is false.’’ (Comment 526).

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2. Directional Statements Undermine statement on a label, it ‘‘should be balanced information is only credible if the Mandatory Government Warning worded and displayed in a manner that there is a reasonable likelihood that Statement and May Be in Violation of does not overshadow, contradict, or such referral will in fact result.’’ the Alcoholic Beverage Labeling Act undermine the government warning (Comment 400). CSPI suggested that NCADD’s comment stated that the label. For example, the claim should ‘‘according to consumer research, few directional statements approved by ATF appear in the same type size and style people would actually look at or write in 1999 ‘‘are misleading and potentially as the government warning label, and for the Dietary Guidelines on the basis confusing to consumers in juxtaposition should not contain any claim that of the label language.’’ CSPI and others to the federally mandated government contradicts any of the statements in the questioned whether consumers would warning on all alcoholic beverage warning label.’’ (Comment 400). get complete information from either the Senator Thurmond testified that the Dietary Guidelines or their doctors. containers sold in the United States.’’ purpose of the ABLA was to provide ‘‘a Similar points were raised in the (Comment 15). Similarly, MADD clear, non-confusing reminder of the testimony of Mr. James Mosher on commented that ‘‘[t]he public and health hazards associated with alcohol behalf of the California Council on particularly youth are being given a consumption.’’ (April 25, 2000; Alcohol Policy, a nonprofit membership mixed message with the inclusion of Washington, DC, page 17). Senator organization dedicated to promoting ‘health messages’ in alcohol advertising Thurmond suggested that ‘‘the two public health approaches to the and on warning labels and the net result directional statements which the ATF prevention of alcohol-related problems. is consumer confusion.’’ (Comment 20). approved last year dilutes the required Mr. Mosher argued that the directional MADD also noted that ‘‘[w]arning labels warnings and, worse, may be seen as the labels were inherently misleading and on alcoholic beverages were created for government’s endorsement of drinking. thus did not constitute protected a specific purpose—to make the As one of the authors of the Alcohol commercial speech under the First consumer aware of the potential harm Beverage Labeling Act, let me stress that Amendment. Because the directional they could suffer as a result of the use the intent of the legislation was to statements themselves make no claim or abuse of the product.’’ exclude such misleading statements.’’ about the effects on health of alcohol The United Communities Against Id. In response to the First Amendment consumption, Mr. Mosher suggested Drug & Alcohol Abuse commented that concerns raised by some individuals, that the key to determining whether ‘‘Congress has already required a Senator Thurmond suggested that at a they would mislead consumers depends warning statement on alcoholic- minimum, ‘‘groups supporting health- upon ‘‘the sources to be consulted, the beverage containers. Any other related statements should be required to likelihood of consumers actually reference to health impacts or benefits is prove beyond any reasonable doubt that consulting them, and the possibility that likely to confuse consumers and such claims are not misleading and do the wording will lead to consumer undermine the impact of the existing not detract from the government confusion, misleading or deceptive warning statement.’’ (Comment 31). The warning.’’ (Id. at page 18). impressions.’’ (May 23, 2000; San American Council on Alcohol Problems In addition to Senator Thurmond’s Francisco, CA, page 92). urged ATF ‘‘not to contribute to comment, a letter signed by Senators confusion by allowing any insinuation Thurmond, Byrd, and Helms supported 4. Directional Statements Are of health benefits from alcohol a ban on all health-related statements Misleading Because Drinkers Are Likely consumption.’’ (Comment 37). and directional health statements on To Rationalize Their Consumption Dr. Thomas Greenfield, a labels. (Comment 526). In this comment, Patterns psychologist, testified in opposition to the three Senators stated that the As previously mentioned, several the use of health-related statements. He directional statements approved by ATF doctors who have been certified by the stated he was principal investigator of in 1999 ‘‘dilute the required government American Society of Addiction the Impact of Alcoholic Beverage warning and mislead consumers. In fact, Medicine commented in opposition to Warning Labels Research Project from these labels might inappropriately be the use of both health claims and 1991–1997. He stated that research seen as the government’s endorsement health-related directional statements in showed that the mandatory Government of alcohol consumption.’’ The comment the labeling and advertising of wines. warning statement had ‘‘fragile but also noted the difficulty of presenting a These commenters suggested that health beneficial effects’’ and that ‘‘one must balanced statement on the effects on claims and directional statements could be concerned that a vague health effects health of alcohol consumption on an be misconstrued by problem drinkers in message, by implication positive, may alcohol beverage label. The Senators order to rationalize their own levels of wipe out the small gains in reminding stated that ‘‘Congress has spoken clearly consumption. For example, one doctor the public of situational hazards of on this important public health issue. suggested that these statements could be drinking when driving or pregnant, and The purpose of the ABLA should not be misconstrued by consumers, because also the health risks.’’ (May 24, 2000; subverted.’’ ‘‘consumers, especially those with a San Francisco, CA, pages 182–183). He vulnerability to alcoholism, may take suggested that in order to be truly 3. Directional Statements Are the message as an endorsement of neutral, a directional statement ‘‘should Misleading Because Drinkers Are excessive drinking.’’ Accordingly, he have a tone that would be to look at the Unlikely To Seek Health Information urged that ATF ‘‘prohibit the alcoholic- health risks and health benefits, and Many commenters suggested that the beverage industry from making these potential health benefits. And one directional statements were misleading misleading and potentially dangerous would have to do it in such a way that because the CSAP consumer survey claims.’’ (Comment 167). it emphasized that—which is, we established that consumers who read Another medical doctor urged ATF to believe, strongly the case—that the the directional labels were unlikely to rescind approval of the directional health benefits [are] * * * relatively seek additional information from their labeling statements, stating that ‘‘[a] small in comparison to the health doctors or send for the Dietary brief message on any beverage container harms.’’ (Id. at page 191). Guidelines. For example, CSPI argued will not provide consumers with CSPI commented that if ATF allowed that ‘‘referring consumers to a adequate information about use of any health claim or health-related government publication which offers alcohol for health-related reasons. Due

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to the publicity in the past few years The Marin Institute for the Prevention of factors influencing the net health about the health benefits of moderate of Alcohol and Other Drug Problems effect of alcohol, I think it is really quite alcohol consumption, a brief label may (Comment 324) suggested that the foolhardy to believe that any one- be interpreted by the uninformed directional statements attributed sentence generic health claim about consumer as a government-authorized positive effects on health to the moderate wine consumption would statement supporting consumption of consumption of alcohol beverages, and serve public-health interests, or even alcohol for health benefit.’’ (Comment were thus ‘‘misleading and potentially provide reliable consumer advice. In 410). dangerous because media and marketing addition to the gross simplification of a NCADD also cited the CSAP study as messages can be misinterpreted as complex risk/benefit analysis, the labels establishing that focus group members public health recommendations.’’ The will also lead to several other levels of were ‘‘generally aware’’ of the reports on Marin Institute stated that the ‘‘60 confusion.’’ (April 25, 2000; positive effects on health of wine Minutes’’ report on the possible heart Washington, DC, page 90). In particular, consumption, and that the heavier protective effects of drinking red wine he noted that few consumers would drinkers were more aware of the media led to a 44 percent increase in red wine actually consult the Dietary Guidelines reports. NCADD suggested that heavy sales. They quoted the marketing for information on the effects of alcohol drinkers would use these ‘‘beliefs’’ manager of a winery as stating in consumption, that many people who about the effects on health of wine ‘‘Impact’’ magazine in 1997 that notice the label would interpret the consumption to justify their drinking information about health benefits was phrase ‘‘health effects’’ as ‘‘healthy levels. (Comment 15). ‘‘increasing consumption more than effects,’’ that there is considerable Ms. Joan Kiley, coordinator of the anything else.’’ Ms. Hilary Abramson confusion about what constitutes Alcohol Policy Network of Alameda testified on behalf of the Marin Institute moderate drinking, and that if County, testified in favor of a complete at the San Francisco hearing that the so- consumers do consult their family ban on health claims or health-related called French Paradox (‘‘the apparent physician, ‘‘it is very unlikely the statements in the labeling or advertising coexistence in France of a low heart physician will be in a position to of alcohol beverages. She stated that the disease rate and a diet rich in saturated provide accurate, up-to-date information directional statements were inherently fat, and the belief that alcohol [red about all of the risks and benefits of misleading, since they were wine] is the explanation for it’’) had moderate drinking.’’ (April 25, 2000; ‘‘incomplete statements that do not put been overestimated, and the French Washington, DC, pages 91–92). Dr. research results in their proper context.’’ heart disease statistics underestimated. Camargo also noted that ‘‘generic health (May 24, 2000; San Francisco, CA, page She stated that after the 60 Minutes claims are likely to be misinterpreted by 228). Ms. Kiley noted that ‘‘[c]onsumers Broadcast in November 1991 on the those at greatest risk of alcohol are not always aware of the effect that French Paradox, ‘‘sales of red wine in problems, a group that would likely use images and attitudes promoted in the United States rocketed 44%, and a the health claim to justify continued or advertising have on their own desires.’’ Gallup poll showed that 58% of increased consumption of excessive (Id. at page 232). In response to a Americans were aware of research alcohol with all of its attendant health question from the panel, Ms. Kiley said linking moderate drinking to lower rates hazards.’’ (Id. at page 92). that in her experience, people with of heart disease.’’ (May 23, 2000; San Dr. Criqui also testified that because alcohol problems were ‘‘very skilled at Francisco, CA, pages 115–116). of the negative health consequences finding good reasons to drink. They Similarly, the Greater Spokane associated with alcohol consumption * * * can use a multiple number of Substance Abuse Council’s Prevention and abuse, the directional statements reasons to drink, that might just be Center commented that ‘‘[a]ny statement are inherently misleading. (May 23, another one.’’ (Id. at page 239). or labeling in reference to supposed 2000; San Francisco, CA, page 60). He 5. Directional Statements Could Be ‘health benefits’ could be construed by stated that the approved directional Interpreted as the Government’s an uninformed consumer population as statements appear to implicitly endorse Endorsement of Alcohol Consumption a government endorsement to consume the value of alcohol as a a likely harmful product.’’ (Comment pharmacological protective agent. (Id. at The former Surgeon General, Dr. 32). The American Council on Alcohol page 59). Dr. Criqui offered his opinion David Satcher, testified that it was Problems also commented that ‘‘[i]f that consumers interpret the approved important to ‘‘carefully consider any health claims are allowed on labels or statements as substantive health claims, action, whether it involves the health even implied, many uninformed which means that at least for most warning or claims that could encourage consumers would interpret this as a people drinking is good and has health underage drinking or mislead about the government sanctioned statement benefits and that the Government very real, adverse health consequences.’’ suggesting that people drink alcohol for endorses this position. Because the (April 25, 2000; Washington, DC, page their health. Quite to the contrary, directional statements are recent and 73). Dr. Satcher stated he was research clearly shows that any measure come in the context of media discussion ‘‘concerned that references to the U.S. which increases the level of alcohol about the possible benefits of alcohol dietary guidelines on the labels of consumption will result in increased consumption, Dr. Criqui stated that the certain wine products could wrongly levels of disease and accidents.’’ statements are likely to be interpreted as lead consumers to conclude that (Comment 37). implicitly endorsing alcohol consumption of wine would reduce consumption as being potentially health risks or that it was recommended 6. Other Testimony Against Directional healthy, since they do not emphasize or by guidelines or by family physicians. Statements even mention the dangers of alcohol References to alcohol in the guidelines Many of the medical experts who consumption. (Id. at pages 59–60). should not be construed as evidence of testified at the public hearings Some people suggested that health benefits nor encouragement that expressed concerns that the directional consumers would interpret the consumers drink. * * * In fact, the statements would mislead consumers directional statements as making Public Health Service does not about the effects on health of alcohol positive health-related claims simply recommend consumption of alcohol consumption. For example, Dr. Camargo because of an assumption that the beverages.’’ (Id. at page 74). concluded that ‘‘with all of these variety industry would not use the statements

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unless they were positive. For example, explore whether consumers would experts on the medical research Dr. Duke, representing the Ethics and interpret the statements as encouraging regarding alcohol and health. For Religious Liberty Commission, the the consumption of alcohol for health example, Dr. Camargo testified that in moral concerns agency for the Southern reasons. Since TTB has no consumer his opinion, consumers would interpret Baptist Convention, suggested that the data on this issue, we must rely upon the phrase ‘‘health effects’’ to mean directional statements were misleading the secondary data that is available to ‘‘healthy effects.’’ (April 25, 2000; because they ‘‘create an impression of us, including the opinions of medical Washington, DC, pages 90–92). Dr. endorsement of the health claims made and public health experts in the field of Criqui offered his opinion that the by the alcohol industry. * * * The alcohol and health. approved directional statements appear average person would not conclude that Initially, TTB would note that many to implicitly endorse the value of the alcohol industry would direct media reports about approval of the alcohol as a pharmacological protective people to information damaging to their directional statements referred to these agent, and that consumers interpret the claim. Consequently, the average person statements as health claims or approved statements as substantive will assume a doctor would agree that references to health benefits. See section health claims meaning that at least for drinking alcohol is good for one’s VII, infra. We recognize that these most people drinking is good and has health.’’ (April 25, 2000; Washington, reports only indirectly reflect consumer health benefits and that the Government DC, 154–155). reactions to the directional statements, endorses this position. Because the Ms. Diana Conti testified on behalf of and that they may have been influenced directional statements are recent and the American Public Health Association by the industry’s or the public health come in the context of media discussion in support of a ban on all health-related sector’s characterizations of the about the possible benefits of alcohol statements on labels and in statements. Nonetheless, to the extent consumption, Dr. Criqui stated that the advertisements, other than the required that these media reports both reflect and statements are likely to be interpreted as warning statement. Ms. Conti suggested shape the perceptions of consumers, we implicitly endorsing alcohol that the directional statement regarding believe that these reports are persuasive consumption as being potentially the Dietary Guidelines ‘‘provides no evidence that the directional statements healthy, since they do not emphasize or specific information, no definition of are perceived by many as making a even mention the dangers of alcohol moderate drinking, and no cautions to positive claim about the effects on consumption. (May 23, 2000; San those who should not drink. The health of alcohol consumption. Francisco, CA, pages 59–60). message is confusing and it’s We are also persuaded by the TTB does not disregard the testimony contradictory to the warning label.’’ opinions of many of the foremost public of those medical professionals, (May 23, 2000; San Francisco, CA, page health experts in the nation. These including Dr. Apstein, Dr. Finkel, and 106). She stated that ‘‘[t]he lack of public health experts believe that the Dr. Scholten, who testified in favor of substantive information creates the allegedly neutral directional statements the use of directional statements. We impression that the government says in fact communicated a message that the agree that industry members have the moderate wine consumption is good for Government endorsed drinking for right to suggest, in labels or in your health, and few, if any, will health reasons, or that the Dietary advertisements, that consumers refer to actually read the guidelines for the more Guidelines or a family physician would third party sources for additional complete information.’’ (Id. at page 107). endorse the consumption of alcohol for information regarding the effects on health reasons. For example, the former health of alcohol consumption. The C. Decision United States Surgeon General testified question presented is how to make such When ATF approved the directional that he was ‘‘concerned that references referrals without misleading consumers. statements in 1999, it concluded that to the U.S. dietary guidelines on the We would also note that many of the the record did not establish that the labels of certain wine products could comments in favor of the use of statements would mislead consumers wrongly lead consumers to conclude directional statements referred to the about the risks associated with alcohol that consumption of wine would reduce need to provide ‘‘balance’’ to the consumption. ATF relied heavily upon health risks or that it was recommended negative message of the health warning the CSAP consumer survey, which by guidelines or by family physicians.’’ statement, and thus implicitly concluded that the directional (April 25, 2000; Washington, DC, page recognized that the directional statements would not encourage most 74). Similarly, the American Cancer statements were meant to convey a consumers to alter their consumption Society noted that ‘‘[w]ith the publicity positive message about the effects on levels or patterns. in the past few years about the health health of alcohol consumption. In this After careful consideration of the benefits of consuming alcoholic regard, it is noteworthy that in a comments and testimony on this issue, beverages, any less-detailed claim or comment submitted after the hearings it is TTB’s conclusion that while the reference to health impacts or benefits were held, Beer Institute suggested that two directional statements approved in might be interpreted by the uninformed the position of several proponents of 1999 were worded in a way that was consumer as a suggestion that people directional statements that such intended to represent a neutral referral should drink alcohol for their health’’ statements did not constitute health to doctors or the Dietary Guidelines for and concluded that directional labels claims was inconsistent with those same additional information, the statements ‘‘may mislead the general public proponents’ attempts ‘‘to defend the were capable of being interpreted in a regarding the health benefits of alcohol directional statements by relying on very different fashion. In particular, the consumption by providing inadequate well-known published medical statements could be interpreted as information regarding the risks.’’ literature that attributes certain health encouraging the consumption of alcohol (Comment 527). Other commenters, benefits to the moderate consumption of for health reasons. including the American Medical alcohol beverages. Given the history of While the CSAP survey established Association and the Marin Institute, this issue and the evidence cited by that the vast majority of consumers supported a ban on directional supporters of the directional statements, would not alter their consumption statements for similar reasons. it seems impossible to characterize the patterns after exposure to the two TTB also finds persuasive the directional statements as anything but directional statements, it did not testimony of many of the foremost health claims subject to the automatic

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qualifying provisions of the proposed suggested that public policy and determined by regulation, any nutrient new regulations.’’ (Comment 396b). regulatory policy require fair and equal in an amount that increases to persons After careful consideration of the treatment for each form of beverage in the general population the risk of a comments and testimony in the alcohol, and any label statement for a disease or health-related condition that rulemaking record, it is TTB’s view that beverage alcohol container should apply is diet-related. 21 U.S.C. 343(r)(3)(A)(ii). the directional statements approved in equally to each type of beverage alcohol. FDA may grant an exception to allow 1999 may be interpreted as advocating (Comment 530). foods with disqualifying nutrient levels the consumption of alcohol beverages to bear a health claim if the claim is B. Decision for health reasons. We recognize that accompanied by a disclosure statement producers of alcohol beverages have Both the proposed and final rules regarding the disqualifying nutrient and contended that they have a make it clear that the same standards FDA has determined by regulation that constitutionally protected right to apply to wine, distilled spirits, and malt such a claim would assist consumers in advocate that consumers drink their beverages. The rulemaking record does maintaining healthy dietary practices. products for health reasons. However, if not provide a basis for setting forth 21 U.S.C. 343(r)(3)(A)(ii) and such a claim is made on a label or in different standards for these types of 343(r)(2)(B). FDA requires rigorous an advertisement, it must be made in a alcohol beverages. The two directional evidence to support a conclusion that a truthful and non-misleading fashion. statements approved by ATF in 1999 health claim on a food with a Furthermore, such a claim would fall were both submitted by wineries, and disqualifying nutrient level would assist within the category of a specific health thus both referred to the effects on consumers in maintaining healthy claim, and would be subject to the health of ‘‘wine consumption.’’ To the dietary practices. requirements in the final rule applicable extent that a directional statement FDA expressed the following concern to such claims. To the extent that complies with the standards set forth in about the use of health claims on producers instead wish to make a this final rule, it may be used in the alcohol beverage labels: neutral referral to third parties for labeling of a wine, distilled spirit, or Alcohol beverages are foods for which additional information regarding the malt beverage product. there is evidence of a substantial number of effects on health of alcohol XVIII. Should TTB Adopt the undisputed negative health effects. FDA has consumption, we believe that it is not evaluated the evidence supporting the Procedures Set Forth in FDA’s putative health benefits of alcohol beverages. necessary to provide a disclaimer that Regulations? clarifies that the labeling or advertising Therefore, we cannot say whether health statement should not encourage A. Issue claims for an alcohol beverage would be prohibited under FDA’s existing health claim consumption of alcohol for health Several commenters suggested that authorization process, or if not prohibited, reasons. ATF should adopt the substantive could be authorized with a disclosure Accordingly, the final rule provides standards already in place in FDA’s statement of the type required by 21 U.S.C. that directional statements will not be regulations governing the use of health 343(r)(2)(B). We are concerned, however, that allowed in the labeling or advertising of claims in the labeling of foods. FDA also the evidence for the well-known direct alcohol beverages unless accompanied causative relationships between alcohol and raised several concerns about numerous health risks would be a significant by a disclaimer. The final rule provides consistency between ATF’s proposed a model disclaimer that alcohol hurdle to our concluding that label regulations and its own health claim information about a relationship between beverage producers may use in regulations. consumption of alcohol and a health claim conjunction with a general statement FDA (Comment 327) commented that could assist consumers in maintaining that directs consumers in a neutral or it was ‘‘imperative that [ATF] regulate healthy dietary practices. other non-misleading manner to a third these claims in a manner consistent FDA also noted that the absence of any party for balanced information regarding with the provisions of the Federal Food, significant nutritive value of alcohol the effects on health of alcohol (wine, Drug, and Cosmetic Act (FFDC Act) to products would be another obstacle to distilled spirits, or malt beverage) ensure the meaningful and non- FDA authorizing a health claim for consumption: ‘‘This statement should misleading use of such claims.’’ FDA alcohol beverages. not encourage you to drink or to pointed out that pursuant to the FDA stated that it was concerned that increase your alcohol consumption for Nutrition Labeling and Education Act ‘‘certain therapeutic or curative claims health reasons.’’ It should be noted that (NLEA), a manufacturer may make a sought by manufacturers of alcohol in some cases, an acceptable disclaimer health claim on a food label only if FDA beverages may in fact be claims that might be incorporated into the language determines ‘‘based on the totality of would require regulation of the alcohol of the directional statement itself; thus, publicly available scientific evidence beverages as drugs.’’ It noted that FDA if the directional statement makes it (including evidence from well-designed has authority and responsibility under clear that it is not advocating studies conducted in a manner which is the FFDC Act to regulate all products consumption of alcohol for health consistent with generally recognized bearing drug claims, and that the term reasons, then an additional disclaimer scientific procedures and principles), ‘‘drug’’ is defined by statute to include may not be necessary. that there is significant scientific an article ‘‘intended for use in the XVII. Should the Same Standards agreement, among experts qualified by diagnosis, cure, mitigation, treatment or Apply to Wines, Distilled Spirits, and scientific training and experience to prevention of disease.’’ 21 U.S.C. Malt Beverages? evaluate such claims, that the claim is 321(g)(1)(B). FDA concluded that supported by such evidence.’’ 21 U.S.C. ‘‘[a]lcohol beverages could fall within A. Issue 343(r)(3)(B)(i). this definition if their labeling contains The DISCUS comment opposed the FDA also noted that the use of claims drug claims.’’ Bureau’s suggested ‘‘case-by-case’’ for foods that may have a negative FDA expressed a concern that certain approach, noting that the effects on health impact generally is not health claims that would be allowed health of alcohol consumption apply appropriate under the NLEA. The under ATF’s proposed rule might render across the board to all beverage alcohol statute provides that a health claim may the product a drug subject to regulation products. Accordingly, DISCUS not be made for a food that contains, as under the FFDC Act. The FFDC Act

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provides that any drug that is not among the most vexing public health beverage producers do not violate the generally recognized by qualified problems facing the United States. new drug provisions of the FFDC Act experts as safe and effective for use Indeed, alcohol is the nation’s number when seeking to use specific health under the conditions prescribed, one drug problem among youth.’’ While claims on alcohol beverage labels. It recommended, or suggested in its CSAP did not take a position on any of would be where the use of that claim labeling, or that has not been used to a the issues on which comment was would render the product subject to material extent or for a material time sought, it noted that ‘‘[o]ne of the key FDA’s jurisdiction over drugs. under such conditions, is a ‘‘new drug.’’ issues challenging our efforts is the Furthermore, FDA’s authority over new 21 U.S.C. 321(p). A new drug may not mixed or misleading messages that drugs has significant public health and be legally marketed unless FDA has consumers receive from a variety of safety consequences. TTB does not wish approved a new drug application for sources. The addition of health related to create any confusion on the part of such a drug. 21 U.S.C. 331(d) and information on beverage alcohol labels industry members regarding their 355(a). FDA noted that the FFDC Act must be carefully considered in relation obligations to comply with FDA’s requires substantial evidence of to the general public’s understanding of requirements over drug claims. effectiveness and evidence that the drug alcohol-related health risk.’’ (Comment In the past, ATF merely advised is safe for its intended use before FDA 430). industry members that they should be will approve a new drug application. 21 CSPI suggested that ATF adopt aware of the fact that the use of a health U.S.C. 355(d). FDA suggested that this regulations similar to FDA’s regulations claim on an alcohol beverage label may standard differed from the ‘‘not under the NLEA, noting that USDA did subject the product to FDA’s misleading’’ standard proposed by the so on a voluntary basis for health claims jurisdiction. However, after reviewing ATF notice of proposed rulemaking. on meat and poultry. CSPI stated that the comments on this issue, we met FDA advised that ATF should under regulations similar to those of with FDA to discuss a process whereby explicitly articulate in its regulations FDA, health claims would be prohibited TTB and FDA could consult on the use the processes by which it would review because alcohol consumption increases of specific health claims on alcohol claims intended for alcohol beverages. It the risk of other diseases, noting that beverage labels. In this way, FDA would stated that it was unable to determine, ‘‘[t]o allow health claims for alcohol, have an opportunity to object to the use based on the proposed rule, whether the America’s most devastating drug, while of a specific health claim, based on its proposed process for a review of health- health claims for foods such as whole jurisdiction over drugs, prior to any TTB related statements would be consistent milk are prohibited, would be action. with FDA’s statutory and regulatory indefensible and would make a mockery Accordingly, the final rule now authorities. Accordingly, FDA urged of the federal government’s health-claim provides that TTB will consult with ATF to clarify the process and criteria regime.’’ FDA, as needed, on the use of specific it intends to use to substantiate the CSPI also noted that if an alcohol health claims on labels. If FDA validity of any health claims or other beverage label or advertisement claims determines that a specific health claim health-related statements before that alcohol may reduce the risk of is a drug claim that is not in compliance finalizing the proposed rule. disease, the beverage may be regulated with the requirements of the FFDC Act, The former Surgeon General, Dr. as a drug by FDA. CSPI argued that, TTB will not approve the use of such David Satcher, also testified in support ‘‘aside from its regulatory classification, statement on a label. There is no similar of adopting standards ‘‘consistent with alcohol is a drug. Depending on a provision in the advertising regulations, that relied upon by the Food and Drug variety of factors such as dose and since advertisers are not required to Administration or for regulated health schedule of use, individual metabolism, obtain prior approval from TTB. We will claims for foods and drugs.’’ (April 25, personality factors, and situation, of course consult with FDA, as 2000; Washington, DC, page 77). alcohol is variously a stimulant and appropriate, if the question arises as to Accordingly, ‘‘[c]laims should be based depressant, euphorigan and soporific, whether an advertisement is in violation on significant scientific agreement, and irritant and anxiety reducer. Alcohol, of the FFDC Act. they should be qualified to identify like other intoxicants, can produce such those categories of persons for whom dependency phenomena as persistent XIX. Is the Final Rule Consistent With the claims are relevant, as well as to search behavior, withdrawal, relapse, the First Amendment? identify those for whom the negative and loss of control.’’ A. Issue consequences would outweigh any positive effect.’’ (Id. at page 78). In B. Decision As previously noted, many response to a question from the panel, After giving careful consideration to commenters suggested that the proposed Dr. Satcher agreed that there were these comments, and consulting with rule did not comply with the protection problems with consumers self- FDA, TTB does not agree that its health accorded truthful and non-misleading medicating without knowing all the claim regulations should be identical to commercial speech under the First facts, noting that ‘‘with alcohol, you also those of FDA. FDA regulations were Amendment. CEI and CA argued that have the added effect that you are promulgated pursuant to a very specific ATF is precluded from placing any dealing with an addictive drug.’’ (Id. at grant of authority by Congress under the restrictions on the dissemination of page 80). Senator Thurmond also NLEA. Because of the differences in truthful information about health commented that ‘‘[a]pplication of the statutory authority, as well as the benefits in the labeling and advertising FFDC Act to this issue would appear to differences in the products regulated of alcohol beverages. Beer Institute, prohibit any health-related statements under these two statutes, TTB’s DISCUS, and NABI suggested that the on alcohol beverage labels. It is absurd regulatory scheme for health claim proposed advertising regulations would that the government would prevent labeling will differ from FDA’s restrict protected commercial speech. whole milk from making health-related regulatory scheme. Mr. Rex Davis, representing the claims but allow such claims by alcohol However, TTB agrees with the FDA President’s Forum of the Beverage beverages.’’ (Comment 526). comment in several respects. Most Alcohol Industry, testified that he CSAP commented that ‘‘[a]lcohol importantly, we agree that it is believes the proposed rule violates the abuse and alcoholism continue to be important to ensure that alcohol First Amendment because it would

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restrict the industry from For example, the government might Information on alcohol beverage labels communicating the benefits of alcohol legitimately require a disclaimer is considered commercial speech. Rubin consumption through labels and warning consumers of the possible link v. Coors Brewing Co., 514 U.S. 476, 481 advertisements. (April 26, 2000; between moderate drinking and breast (1995). Commercial speech is generally Washington, DC, pages 133–141). Many cancer, and also a statement warning protected by the First Amendment; other commenters defended the certain vulnerable consumers not to however, it enjoys a more limited constitutionality of a complete ban on drink at all.’’ Mr. Bierbauer concluded measure of protection. Florida Bar v. the use of health-related statements in that ‘‘[a]ds and labels that merely direct Went For It, Inc., 515 U.S. 618 (1995). the labeling and advertising of alcohol the consumer to other sources of Nonetheless, the Government bears the beverages. information, such as the wine labels burden of justifying a restriction on Some of the comments that (or approved by ATF in February 1999, commercial speech. See Greater New commentators who) addressed the First clearly would enjoy First Amendment Orleans Broadcasting Ass’n v. United Amendment issue suggested that while protection.’’ States, 527 U.S. 173, 183 (1999). ATF would have authority to restrict the In order to regulate commercial use of misleading health claims, a B. Decision speech, the Government must satisfy a complete ban on the use of health- As set forth in this final rule, TTB is 4-prong test. Central Hudson Gas & related statements would be not imposing a complete ban on the use Electric Corp. v. Public Serv. Comm’n, unconstitutional. For example, the of health claims or other health-related 447 U.S. 557, 563–566 (1980). First, the Washington Legal Foundation statements in the labeling and expression is protected by the First concluded that an outright ban on the advertising of alcohol beverages. Amendment only if it concerns lawful use of truthful health claims would be Accordingly, it is not necessary to activity and is not misleading. Second, unconstitutional, but stated that the consider whether such a ban would be the Government must establish a proposed regulations, ‘‘if properly constitutional. Instead, the final rule substantial interest. Third, the implemented, strike the appropriate requires TTB to evaluate health claims regulation must directly advance the balance in ensuring the First on a case-by-case basis to determine if governmental interest asserted. Finally, Amendment rights of industry and such claims would tend to mislead the the regulation must be no more consumers, and the dissemination of consumer. extensive than necessary to serve the important information regarding the The final rule codifies ATF’s interest asserted. health benefits proven to flow from longstanding position that any In two recent cases involving alcohol moderate consumption of alcohol substantive health benefit claim is beverages, the Supreme Court has struck beverages.’’ (Comment 390). A comment considered misleading unless it is down bans on truthful and non- submitted on behalf of the Oregon truthful and adequately substantiated by misleading commercial speech. In Winegrower’s Association also stated scientific or medical evidence; Rubin v. Coors Brewing Co., 514 U.S. that a ban on the use of health claims sufficiently detailed and qualified with 476, 491 (1995), the Supreme Court on labels or in advertisements would be respect to the categories of individuals applied the Central Hudson analysis in unconstitutional; however, the comment to whom the claim applies; adequately striking down the FAA Act’s prohibition stated that the agency should instead discloses the health risks associated against statements of alcohol content on ‘‘adhere to a policy of allowing labeling with alcohol consumption; and outlines malt beverage labels unless required by and advertising claims about such the categories of individuals for whom State law. In 44 Liquormart, Inc. v. health-related benefits to be fairly and any levels of alcohol consumption may Rhode Island, 517 U.S. 484 (1996), the objectively evaluated for substantiation, cause health risks. The final rule Supreme Court struck down Rhode balance and qualification.’’ (Comment clarifies that the identified health risks Island’s ban on advertising the price of 380). must include those associated with both alcohol beverages on First Amendment A comment from Mr. Erik Bierbauer moderate and higher levels of grounds. More recently, in Lorillard (Comment 395) attached a copy of a consumption. Thus, the rule would Tobacco Co. v. Reilly, 533 U.S. 525 note that he wrote for the New York require any such claim to include (2001), the Supreme Court struck down University Law Review as a third-year appropriate qualifications and certain restrictions imposed by the State law student, entitled ‘‘Liquid Honesty: disclaimers about the health risks of Massachusetts on the advertisement The First Amendment Right to Market associated with alcohol consumption. In of tobacco products on First the Health Benefits of Moderate Alcohol addition, health-related directional Amendment grounds. However, none of Consumption,’’ 74 N.Y.U.L. Rev. 1057 statements that are not substantive these decisions restricts the (1999). The note concludes that alcohol health claims must nonetheless include Government’s authority to regulate producers have a First Amendment right a disclaimer to clarify that the statement misleading or potentially misleading to market the health benefits of does not advocate the consumption of commercial speech. moderate drinking, as long as they do so alcohol beverages for health reasons, or If commercial speech is actually accurately and include certain limited some other appropriate disclaimer to misleading, then it is not protected by disclaimers. Mr. Bierbauer suggested avoid misleading consumers. The rule’s the First Amendment. If commercial that while such limited disclaimers requirements for appropriate speech is potentially misleading, the would be constitutionally authorized, disclaimers and qualifications in order Government may regulate such ‘‘the sort of disclosure described in to avoid consumer deception about a commercial messages if the restrictions ATF’s Industry Circular 93–8 probably health issue comport completely with are ‘‘no broader than reasonably would be too burdensome to comply the safeguards articulated by the necessary to prevent the deception.’’ In with the First Amendment.’’ However, Supreme Court to protect non- re R.M.J., 455 U.S. 191, 203 (1982). Mr. Bierbauer’s comment suggested that misleading commercial speech. Potentially misleading speech cannot be ‘‘[t]he Constitution would permit the Commercial speech is defined as banned ‘‘if the information also may be government to require health-related speech that proposes a commercial presented in a way that is not alcohol advertisements and labels to transaction. Virginia State Board of deceptive’’ through the use of mention lesser-known risks that are Pharmacy v. Virginia Citizens Consumer ‘‘disclaimers or explanation.’’ Id. present at moderate levels of drinking. Council, Inc., 425 U.S. 748, 762 (1976). Requirements for disclaimers have been

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upheld as long as the disclaimers are to drive a car or operate machinery, and sufficiently detailed and qualified with ‘‘reasonably related to the State’s may cause health problems.’’ CEI and respect to the categories of individuals interest in preventing deception’’ and CA further suggest that consumers are to whom the claim applies; adequately do not constitute an undue burden on well aware of the health risks associated disclose the health risks associated with the advertiser. Zauderer v. Office of with alcohol abuse, and there is no need both moderate and heavier levels of Disciplinary Counsel, 471 U.S. 626, to remind them of such risks. alcohol consumption; and outline the 651–53 (1985). TTB does not agree with this categories of individuals for whom any TTB recognizes that under the comment. The administrative record levels of alcohol consumption may commercial speech doctrine, there is a contains overwhelming evidence of the cause health risks. Most consumers are preference for disclosure over serious health risks associated with unable to conduct or verify health suppression. See e.g., Zauderer and alcohol consumption. These risks are research for themselves to determine Pearson v. Shalala, 164 F.3d 650 (D.C. not merely hypothetical; they are well whether a health claim is valid as to Cir. 1999). In Pearson, the Court of documented. Among other things, the their own alcohol consumption, and are Appeals for the D.C. Circuit required the comments established that over 8 ill equipped to interpret the medical Food and Drug Administration to million American adults are alcoholics; data, evaluate the potential benefits, or consider appropriate disclaimers for alcohol is a known human carcinogen; identify and weigh the other medical health claims on dietary supplement and alcohol contributes to the deaths of factors that may bear upon their labels. The Court noted that ‘‘the more than 100,000 Americans each year. individual decision to use alcohol for government’s interest in preventing the Furthermore, alcohol abuse has therapeutic reasons. See In re R.M.J., use of labels that are true but do not devastating effects on innocent third 455 U.S. at 202 (the public’s mention adverse effects would seem to parties. In 1998, 15,935 people were comparative lack of knowledge be satisfied—at least ordinarily—by killed in alcohol-related traffic crashes, regarding the product being advertised inclusion of a prominent disclaimer and an estimated 850,000 were injured. is an important factor in determining setting forth those adverse effects.’’ 164 Mothers Against Drunk Driving whether speech is misleading). A F.3d at 659. commented that the NIH estimated that requirement for disclaimers of this Consistent with the Supreme Court the overall societal costs of alcohol nature in such a situation is clearly cases cited above, as well as the DC abuse and alcoholism in 1995 ($167 directly related to the Government’s Circuit’s ruling in the Pearson case, the billion) were more than 50 percent interest in ensuring that consumers are final rule requires any industry member higher than the costs to society of illegal not misled by health statements on who wishes to make an explicit or drug use ($110 billion). The health risks alcohol beverage labels. implicit health claim on a label or in an associated with alcohol consumption Some commenters suggested that the advertisement to make a more complete are not simply hypothetical; on the types of disclaimers and qualifications disclosure of the adverse effects on contrary, they present a serious public required by the proposed regulations health caused by alcohol consumption. health problem in this country. would overly burden industry members The final rule does not impose any Accordingly, the record supports a who wish to make health claims about additional requirements on industry conclusion that a health claim that does alcohol consumption, making such members who do not wish to make such not include information about these requirements unconstitutional. CEI and claims. However, given the very serious serious health risks would tend to CA suggested that ‘‘summary’’ health health risks associated with alcohol mislead consumers about the health claims for alcohol consumption are just consumption, TTB believes that the use consequences of alcohol consumption. as truthful as other short health claims of health claims without such TTB also disagrees with the allowed by FDA for diets low in qualifications and disclaimers would be suggestion by CEI and CA that health- saturated fat and cholesterol, as well as misleading to consumers. related statements presented a necessary diets low in sodium. Other commenters The final rule is completely consistent ‘‘balance’’ to the warning presented by suggested that because an alcohol with the preference expressed by the the mandatory Government warning beverage label is not large enough to courts for disclosure over suppression statement. The warning statement was include the volume of information in the commercial speech arena. The intended by Congress to present a clear necessary in order to give consumers a Supreme Court has held that more and nonconfusing reminder of the complete picture of the effects on health speech, not less, is the preferred means health hazards associated with of alcohol consumption, such of ensuring that consumers have consumption or abuse of alcohol statements should be banned sufficient information to make informed beverages. See 27 U.S.C. 213. The use of completely from alcohol beverage choices in the commercial arena. In re health claims or other health-related labels. R.M.J., 455 U.S. at 203. The final rule statements without qualification or TTB agrees that the regulations make does not ‘‘ban’’ any type of speech disclosure of adverse effects to it difficult to present a substantive regarding health claims or health-related ‘‘balance’’ the mandatory warning health claim (for example, one involving statements in the labeling or advertising statement not only undermines the cardiovascular benefits associated with of alcohol beverages. Instead, the rule intent of the ABLA; it also tends to moderate alcohol consumption) on an simply requires disclaimers for specific confuse consumers about the very real alcohol beverage label, because of the health claims and health-related health risks associated with alcohol level of qualification and explanation directional statements. consumption. that would be necessary to set forth the CEI and CA suggested that there is no The administrative record contains risks associated with such consumption. need for disclaimers in connection with significant evidence that truthful TTB would also note that there seems to health claims in the labeling or statements about certain health benefits be an overwhelming lack of interest on advertising of alcohol beverages. They associated with moderate consumption the part of the alcohol beverage industry point to the fact that the Government of alcohol beverages for certain in using such health claims on alcohol warning statement required on alcohol individuals will tend to mislead beverage labels. The comments from beverage containers already advises consumers unless such statements are major trade associations representing consumers that ‘‘Consumption of truthful and adequately substantiated by wineries, importers, brewers, and alcoholic beverages impairs your ability scientific or medical evidence; distillers did not indicate a concrete

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interest in using substantive health Accordingly, the final rule is in With regard to the ‘‘directional’’ claims in the labeling or advertising of accordance with the case law under the statements approved by ATF in 1999, alcohol beverages. One lawyer testified commercial speech doctrine. Because we recognize that the producers of in support of a 664-word labeling the rule does not ban any speech, but alcohol beverages may have a protected statement regarding effects on health merely sets forth the type of right under the First Amendment to and asserted that members of the wine qualification, detail, and disclosure convey the message on labels and in industry had the right to make such required in order to set forth a non- advertisements that consumers should statements; however, in response to misleading health-related statement in refer to their doctors or the questioning, he conceded that such a the labeling or advertising of alcohol Government’s Dietary Guidelines for long statement would not be likely to be beverages, the rule is completely additional information about the effects used on a label. consistent with the First Amendment on health of alcohol consumption, as In the absence of any concrete protection accorded truthful and non- long as that message is conveyed in a indications of industry interest in using misleading commercial speech. On the fashion that does not mislead substantive health claims on alcohol other hand, the rule is also consistent consumers about the health beverage labels, there is no reason for with TTB’s statutory responsibility to consequences of alcohol consumption. TTB to draft a model health claim for protect consumers from misleading As discussed above, TTB has also use by industry members. Discussions commercial speech regarding the determined that without disclaimers, of whether the regulations would serious effects on health of alcohol the directional statements approved in unduly burden the industry’s ability to consumption. 1999 tended to mislead consumers use qualified and truthful health claims about the health consequences of XX. Final Rule in the labeling of alcohol beverages will alcohol consumption. be better informed if and when industry Accordingly, this final rule amends Accordingly, the final rule provides members submit such statements to TTB the regulations to provide that labels that a health-related directional for review. Nothing in the regulation and advertisements may not contain any statement is presumed misleading itself indicates that the requirements for health-related statement, including a unless it directs consumers in a neutral qualification and balance are unduly specific health claim, that is untrue in or other non-misleading manner to a burdensome. Furthermore, it must be any particular or tends to create a third party or other source for balanced concluded that the length of any misleading impression. A specific information regarding the effects on required disclaimers and qualifications health claim on an alcohol beverage health of alcohol consumption and are directly related to the serious health label or advertisement will be includes as part of the health-related risks associated with alcohol considered misleading unless it is directional statement a brief disclaimer consumption, rather than any desire by truthful and adequately substantiated by stating that the statement should not the Government to suppress speech. In scientific or medical evidence; encourage consumption of alcohol for particular, the comparison made by CEI sufficiently detailed and qualified with health reasons, or some other and CA with claims regarding diets low respect to the categories of individuals appropriate disclaimer to avoid in saturated fat and cholesterol or diets to whom the claim applies; adequately misleading consumers. low in sodium is not persuasive in the discloses the health risks associated As a clarifying change, the final rule absence of any suggestion that such with both moderate and heavier levels uses the term ‘‘health-related statement’’ diets are associated with the types of of alcohol consumption; and outlines instead of ‘‘curative or therapeutic documented health risks associated the categories of individuals for whom claim.’’ However, the definition of a with alcohol consumption. Accordingly, any alcohol consumption poses risks. ‘‘health-related statement’’ in the final TTB concludes that the requirements of This information must appear as part of rule incorporates ATF’s historic the regulations do not unduly burden the specific health claim and, in the position on what constitutes a statement speech about the effects on health of case of advertising, must also appear as of a curative or therapeutic nature, as set alcohol consumption. prominent as the specific health claim. forth in the preamble of it’s final rule Because the directional statements do In addition, TTB will consult with FDA, concerning the labeling and advertising not make substantive health claims, but as needed, on the use of specific health regulations under the FAA Act (T.D. instead have been interpreted as claims on labels. If FDA determines that ATF–180, 49 FR 31667; August 8, 1984). implicitly encouraging the consumption a specific health claim is a drug claim Accordingly, a health-related statement of alcohol for health reasons, TTB does that is not in compliance with the includes any claim of a curative or not believe it is necessary to require the requirements of the FFDC Act, TTB will therapeutic nature that, expressly or by same level of detail in the disclaimers not approve the use of such statement implication, suggests a relationship required to ensure that such statements on a label. between the consumption of alcohol, do not mislead consumers. In addition, The final rule provides that a health- wine, distilled spirits, malt beverages, or there clearly is interest on the part of related statement that is not a specific any substance found within the alcohol several industry members in using the health claim or a health-related beverage, and health benefits or effects directional statements. Accordingly, we directional statement will be allowed in on health. The term ‘‘health-related have provided a model disclaimer that the labeling or advertising of alcohol statement’’ also includes both specific may be used by industry members in beverages only if TTB determines that health claims and general references to conjunction with such directional the claim is not untrue in any particular alleged health benefits or effects on statements in order to avoid misleading and does not tend to create a misleading health associated with the consumption consumers. This one-sentence impression as to the effects on health of of alcohol, wine, distilled spirits, malt disclaimer is not overly burdensome, alcohol consumption. We will evaluate beverages, or any substance found and complies with the court cases such statements on a case-by-case basis within the alcohol beverage, as well as allowing the Government to mandate and may require as part of the health- health-related directional statements. disclosures necessary to prevent related statement a disclaimer or other The term also includes statements and consumer deception. TTB will consider qualifying statement to dispel any claims that imply that a physical or other disclaimers on a case-by-case misleading impression created by the psychological sensation results from basis. health-related statement. consuming wine, distilled spirits, or

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malt beverages, as well as statements XXII. Notes Appearing in Text of by suicide, injury, and natural causes.’’ and claims of nutritional value. Supplementary Information ‘‘American Journal of Public Health’’ 87(3):434–437, 1997. Statements concerning caloric, 1. Hennekens, C.H., ‘‘Alcohol and Risk of carbohydrate, protein, and fat content of 13. Stampfer, M.J.; Rimm, E.B.; Walsh, Coronary Events,’’ Research Monograph No. D.C.; ‘‘Commentary: Alcohol, the Heart, and alcohol beverages are not considered 31, ‘‘Alcohol and the Cardiovascular System’’ Public Policy,’’ ‘‘American Journal of Public nutritional claims about the product. at 15 (National Institutes of Health, National Health,’’ 83(6): 801–804 at 803, 1993. However, statements of vitamin content Institute on Alcohol Abuse and Alcoholism, are considered nutritional value claims, Bethesda, MD, 1996). XXIII. How This Document Complies and will be prohibited if presented in a 2. See, e.g., Boffetta, P. & Garfinkel, L., With the Federal Administrative fashion that tends to mislead consumers ‘‘Alcohol drinking and mortality among men Requirements for Rulemaking as to the nutritional value of the enrolled in an American Cancer Society prospective study,’’ ‘‘Epidemiology’’ A. Executive Order 12866 product. 1(5):342–348, 1990; Stampfer, M.J.; Colditz, TTB has determined that this final The term ‘‘specific health claim’’ is G.A.; Willett, W.C.; Speizer, F.E. & rule is not a significant regulatory action defined as a type of health-related Hennekens, C.H., ‘‘A prospective study of moderate alcohol consumption and the risk as defined in E.O. 12866. Therefore, a statement that, expressly or by regulatory assessment is not required. implication, characterizes the of coronary disease and stroke in women,’’ relationship of the alcohol beverage ‘‘New England Journal of Medicine,’’ B. Regulatory Flexibility Act 319(5):267–273, 1988; Klatsky, A.L.; (e.g., wine, distilled spirits, or malt Armstrong, M.A.; and Friedman, G.D., The Regulatory Flexibility Act (RFA) beverage), alcohol, or any substance ‘‘Alcohol and Mortality,’’ ‘‘Annals of Internal requires an agency to conduct a found within the alcohol beverage, to a Medicine,’’ 117(8):646–654, 1992. See regulatory flexibility analysis of any rule disease or health-related condition. generally National Institute on Alcohol subject to notice and comment Implied specific health claims include Abuse and Alcoholism, ‘‘Moderate rulemaking requirements unless the statements, symbols, vignettes, or other Drinking,’’ ‘‘Alcohol Alert,’’ No. 16, April agency certifies that the rule will not forms of communication that suggest, 1992, at 2, and studies cited therein. have a significant economic impact on 3. See, e.g., Criqui, M.H., ‘‘Moderate within the context in which they are a substantial number of small entities. presented, that a relationship exists Drinking: Benefits and Risks,’’ ‘‘Alcohol and the Cardiovascular System,’’ at 117–118 Small entities include small businesses, between the alcohol beverage (wine, (‘‘Clearly, younger persons cannot possibly small not-for-profit enterprises, and distilled spirits, or malt beverages), benefit much from alcohol consumption, at small governmental jurisdictions. TTB alcohol, or any substance found within least in the short term, because their risk of has certified that this final rule will not the alcohol beverage, and a disease or ischemic CVD events is low.’’) have a significant economic impact on health-related condition. 4. DuFour, M.C., ‘‘Risks and Benefits of a substantial number of small entities. The term ‘‘health-related directional Alcohol Use Over the Life Span,’’ ‘‘Alcohol In general, the final regulations merely Health & Research World,’’ Vol. 20, No. clarify TTB’s existing policy concerning statement’’ is defined as a type of 3:145–150 at 147, 1996. health-related statement that directs or 5. See, e.g., Hennekens, C.H., ‘‘Alcohol and the use of health claims in the labeling refers consumers to a third party or risk of coronary events,’’ Research and advertising of alcohol beverages and other source for information regarding Monograph No. 31, ‘‘Alcohol and the impose no burdens on the industry. the effects on health of alcohol Cardiovascular System’’ at 20 (National With respect to health-related consumption. Institutes of Health, National Institute on statements, TTB believes that the Alcohol Abuse and Alcoholism, Bethesda, The definitions in the final rule also burden imposed by the additional MD 1996) (‘‘while the health risks of wording required by a disclaimer or clarify that TTB is not expanding its excessive drinking are clear, there may also traditional interpretation of a curative or other qualifying statement is minimal. be hazards associated with moderate intake Accordingly, a regulatory flexibility therapeutic claim to cover, for example, that must be weighed, on an individual basis, advertisements in which people are against the apparent protection against analysis is not required. shown relaxing in an enjoyable setting CHD.’’). C. Paperwork Reduction Act while consuming alcohol beverages. 6. Thun, M.J.; Peto, R.; Lopez, A.D.; The provisions of the Paperwork Accordingly, the final rule in no way Monaco, J.H.; Henley, S.J.; Heath, C.W.; and Reduction Act of 1995, Public Law 104– impinges on the right of industry Doll, R; ‘‘Alcohol Consumption and Mortality Among Middle-Aged and Elderly U.S. 13, 44 U.S.C. Chapter 35, and its members to advertise their products in Adults,’’ ‘‘The New England Journal of implementing regulations, 5 CFR part a truthful and non-misleading fashion. Medicine,’’ 337(24):1705–1714 at 1705, 1997. 1320, do not apply to this final rule XXI. Applications for and Certificates 7. Id. at 1712. because no requirement to collect 8. Manson, J.E.; Tosteson, H.; Ridker, P.M.; information is imposed. of Label Approval Satterfield, S; Hebert, P.; O’Connor, G.T.; Upon the effective date of this final Buring, J.E.; and Hennekens, C.H.; ‘‘The Disclosure Primary Prevention of Myocardial rule, applications for certificates of label Infarction,’’ ‘‘The New England Journal of Copies of the notice of proposed approval must be in compliance with Medicine,’’ 326(21):1406–1416 at 1412, 1992. rulemaking, all comments, the hearing the regulations. In accordance with the 9. Fuchs, C.S.; Stampfer, M.J.; Colditz, transcripts, and this final rule will be provisions of 27 CFR 13.51 and G.A.; Giovannucci, E.L.; Manson, J.E.; available for public inspection by 13.72(a)(2), upon the effective date of Kawachi, I.; Hunter, D.J.; Hankinson, S.E.; appointment during normal business this final rule, certificates of label Hennekens, C.H.; Rosner, B; Speizer, F.E.; hours at: TTB Public Reading Room, approval that are not in compliance and Willett, W.C.; ‘‘Alcohol Consumption Room 6480, 650 Massachusetts Avenue, with the regulations will be revoked by and Mortality Among Women,’’ ‘‘The New NW., Washington, DC; 202–927–7890. operation of regulation. Certificate England Journal of Medicine,’’ 332(19):1245– 1250 at 1245, 1995. Drafting Information holders must voluntarily surrender all 10. Id. at 1246. certificates that are no longer in 11. Id. at 1249. The originating drafter of this compliance and submit new 12. Grabbe, L; Demi, A; Camann, M.A.; et document is James P. Ficaretta, applications for certificates that are in al. ‘‘The health status of elderly persons in Regulations Division, Bureau of compliance with the new requirements. the last year of life; A comparison of deaths Alcohol, Tobacco and Firearms.

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However, personnel from other offices (ii) Specific health claim is a type of (A) Directs consumers in a neutral or of the Bureau participated in developing health-related statement that, expressly other non-misleading manner to a third this Treasury decision. or by implication, characterizes the party or other source for balanced relationship of the wine, alcohol, or any information regarding the effects on List of Subjects substance found within the wine, to a health of wine or alcohol consumption; 27 CFR Part 4 disease or health-related condition. and Implied specific health claims include (B)(1) Includes as part of the health- Advertising, Consumer protection, statements, symbols, vignettes, or other related directional statement the Customs duties and inspection, Imports, forms of communication that suggest, following disclaimer: ‘‘This statement Labeling, Packaging and containers, and within the context in which they are should not encourage you to drink or to Wine. presented, that a relationship exists increase your alcohol consumption for 27 CFR Part 5 between wine, alcohol, or any substance health reasons;’’ or found within the wine, and a disease or (2) Includes as part of the health- Advertising, Consumer protection, health-related condition. related directional statement some other Customs duties and inspection, Imports, (iii) Health-related directional qualifying statement that the Labeling, Liquors, and Packaging and statement is a type of health-related appropriate TTB officer finds is containers. statement that directs or refers sufficient to dispel any misleading 27 CFR Part 7 consumers to a third party or other impression conveyed by the health- source for information regarding the related directional statement. Advertising, Consumer protection, effects on health of wine or alcohol Customs duties and inspection, Imports, * * * * * consumption. 3. Section 4.64 is amended by revising and Labeling. (2) Rules for labeling. (i) Health- paragraph (i) to read as follows: Authority and Issuance related statements. In general, labels may not contain any health-related § 4.64 Prohibited practices. For the reasons discussed in the statement that is untrue in any * * * * * preamble, TTB amends 27 CFR Parts 4, particular or tends to create a (i) Health-related statements. (1) 5, and 7 as follows: misleading impression as to the effects Definitions. When used in this on health of alcohol consumption. TTB paragraph (i), terms are defined as PART 4—LABELING AND will evaluate such statements on a case- follows: ADVERTISING OF WINE by-case basis and may require as part of (i) Health-related statement means any statement related to health and 1. The authority citation for 27 CFR the health-related statement a includes statements of a curative or Part 4 continues to read as follows: disclaimer or some other qualifying statement to dispel any misleading therapeutic nature that, expressly or by Authority: 27 U.S.C. 205. impression conveyed by the health- implication, suggest a relationship 2. Section 4.39 is amended by revising related statement. between the consumption of alcohol, paragraph (h) to read as follows: (ii) Specific health claims. (A) TTB wine, or any substance found within the will consult with the Food and Drug wine, and health benefits or effects on § 4.39 Prohibited practices. Administration (FDA), as needed, on the health. The term includes both specific * * * * * use of a specific health claim on a wine health claims and general references to (h) Health-related statements. (1) label. If FDA determines that the use of alleged health benefits or effects on Definitions. When used in this such a labeling claim is a drug claim health associated with the consumption paragraph (h), terms are defined as that is not in compliance with the of alcohol, wine, or any substance found follows: requirements of the Federal Food, Drug, within the wine, as well as health- (i) Health-related statement means and Cosmetic Act, TTB will not approve related directional statements. The term any statement related to health (other the use of that specific health claim on also includes statements and claims that than the warning statement required by a wine label. imply that a physical or psychological § 16.21 of this chapter) and includes (B) TTB will approve the use of a sensation results from consuming the statements of a curative or therapeutic specific health claim on a wine label wine, as well as statements and claims nature that, expressly or by implication, only if the claim is truthful and of nutritional value (e.g., statements of suggest a relationship between the adequately substantiated by scientific or vitamin content). Statements concerning consumption of alcohol, wine, or any medical evidence; sufficiently detailed caloric, carbohydrate, protein, and fat substance found within the wine, and and qualified with respect to the content do not constitute nutritional health benefits or effects on health. The categories of individuals to whom the claims about the product. term includes both specific health claim applies; adequately discloses the (ii) Specific health claim is a type of claims and general references to alleged health risks associated with both health-related statement that, expressly health benefits or effects on health moderate and heavier levels of alcohol or by implication, characterizes the associated with the consumption of consumption; and outlines the relationship of the wine, alcohol, or any alcohol, wine, or any substance found categories of individuals for whom any substance found within the wine, to a within the wine, as well as health- levels of alcohol consumption may disease or health-related condition. related directional statements. The term cause health risks. This information Implied specific health claims include also includes statements and claims that must appear as part of the specific statements, symbols, vignettes, or other imply that a physical or psychological health claim. forms of communication that suggest, sensation results from consuming the (iii) Health-related directional within the context in which they are wine, as well as statements and claims statements. A statement that directs presented, that a relationship exists of nutritional value (e.g., statements of consumers to a third party or other between wine, alcohol, or any substance vitamin content). Statements concerning source for information regarding the found within the wine, and a disease or caloric, carbohydrate, protein, and fat effects on health of wine or alcohol health-related condition. content do not constitute nutritional consumption is presumed misleading (iii) Health-related directional claims about the product. unless it— statement is a type of health-related

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statement that directs or refers impression conveyed by the health- source for information regarding the consumers to a third party or other related directional statement. effects on health of distilled spirits or source for information regarding the * * * * * alcohol consumption. effects on health of wine or alcohol (ii) Rules for labeling. (A) Health- consumption. PART 5—LABELING AND related statements. In general, labels (2) Rules for advertising. (i) Health- ADVERTISING OF DISTILLED SPIRITS may not contain any health-related related statements. In general, statement that is untrue in any 4. The authority citation for 27 CFR particular or tends to create a advertisements may not contain any Part 5 continues to read as follows: health-related statement that is untrue misleading impression as to the effects in any particular or tends to create a Authority: 26 U.S.C. 5301, 7805; 27 U.S.C. on health of alcohol consumption. TTB misleading impression as to the effects 205. will evaluate such statements on a case- on health of alcohol consumption. TTB 5. Section 5.42 is amended by revising by-case basis and may require as part of will evaluate such statements on a case- paragraph (b)(8) to read as follows: the health-related statement a disclaimer or some other qualifying by-case basis and may require as part of § 5.42 Prohibited practices. the health-related statement a statement to dispel any misleading * * * * * disclaimer or some other qualifying impression conveyed by the health- (b) * * * related statement. statement to dispel any misleading (8) Health-related statements. (i) (B) Specific health claims. (1) TTB impression conveyed by the health- Definitions. When used in this related statement. Such disclaimer or paragraph (b)(8), terms are defined as will consult with the Food and Drug other qualifying statement must appear follows: Administration (FDA), as needed, on the as prominent as the health-related (A) Health-related statement means use of a specific health claim on a statement. any statement related to health (other distilled spirits label. If FDA determines (ii) Specific health claims. A specific than the warning statement required by that the use of such a labeling claim is health claim will not be considered § 16.21 of this chapter) and includes a drug claim that is not in compliance misleading if it is truthful and statements of a curative or therapeutic with the requirements of the Federal adequately substantiated by scientific or nature that, expressly or by implication, Food, Drug, and Cosmetic Act, TTB will medical evidence; sufficiently detailed suggest a relationship between the not approve the use of that specific and qualified with respect to the consumption of alcohol, distilled health claim on a distilled spirits label. categories of individuals to whom the spirits, or any substance found within (2) TTB will approve the use of a claim applies; adequately discloses the the distilled spirits, and health benefits specific health claim on a distilled health risks associated with both or effects on health. The term includes spirits label only if the claim is truthful moderate and heavier levels of alcohol both specific health claims and general and adequately substantiated by consumption; and outlines the references to alleged health benefits or scientific or medical evidence; categories of individuals for whom any effects on health associated with the sufficiently detailed and qualified with levels of alcohol consumption may consumption of alcohol, distilled respect to the categories of individuals cause health risks. This information spirits, or any substance found within to whom the claim applies; adequately must appear as part of the specific the distilled spirits, as well as health- discloses the health risks associated health claim and in a manner as related directional statements. The term with both moderate and heavier levels prominent as the specific health claim. also includes statements and claims that of alcohol consumption; and outlines the categories of individuals for whom (iii) Health-related directional imply that a physical or psychological any levels of alcohol consumption may statements. A statement that directs sensation results from consuming the cause health risks. This information consumers to a third party or other distilled spirits, as well as statements must appear as part of the specific source for information regarding the and claims of nutritional value (e.g., health claim. effects on health of wine or alcohol statements of vitamin content). (C) Health-related directional consumption is presumed misleading Statements concerning caloric, statements. A statement that directs unless it— carbohydrate, protein, and fat content do not constitute nutritional claims consumers to a third party or other (A) Directs consumers in a neutral or source for information regarding the other non-misleading manner to a third about the product. (B) Specific health claim is a type of effects on health of distilled spirits or party or other source for balanced health-related statement that, expressly alcohol consumption is presumed information regarding the effects on or by implication, characterizes the misleading unless it— health of wine or alcohol consumption; relationship of the distilled spirits, (1) Directs consumers in a neutral or and alcohol, or any substance found within other non-misleading manner to a third (B)(1) Includes as part of the health- the distilled spirits, to a disease or party or other source for balanced related directional statement, and in a health-related condition. Implied information regarding the effects on manner as prominent as the health- specific health claims include health of distilled spirits or alcohol related directional statement, the statements, symbols, vignettes, or other consumption; and following disclaimer: ‘‘This statement forms of communication that suggest, (2)(i) Includes as part of the health- should not encourage you to drink or within the context in which they are related directional statement the increase your alcohol consumption for presented, that a relationship exists following disclaimer: ‘‘This statement health reasons;’’ or between distilled spirits, alcohol, or any should not encourage you to drink or to (2) Includes as part of the health- substance found within the distilled increase your alcohol consumption for related directional statement, and in a spirits, and a disease or health-related health reasons;’’ or manner as prominent as the health- condition. (ii) Includes as part of the health- related directional statement, some (C) Health-related directional related directional statement some other other qualifying statement that the statement is a type of health-related qualifying statement that the appropriate TTB officer finds is statement that directs or refers appropriate TTB officer finds is sufficient to dispel any misleading consumers to a third party or other sufficient to dispel any misleading

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impression conveyed by the health- on health of alcohol consumption. TTB § 7.29 Prohibited practices. related directional statement. will evaluate such statements on a case- * * * * * * * * * * by-case basis and may require as part of (e) Health-related statements. (1) Par. 6. Section 5.65 is amended by the health-related statement a Definitions. When used in this revising paragraph (d) to read as disclaimer or some other qualifying paragraph (e), terms are defined as follows: statement to dispel any misleading follows: impression conveyed by the health- (i) Health-related statement means § 5.65 Prohibited practices. related statement. Such disclaimer or any statement related to health (other * * * * * other qualifying statement must appear than the warning statement required by (d) Health-related statements. (1) as prominent as the health-related § 16.21 of this chapter) and includes Definitions. When used in this statement. statements of a curative or therapeutic paragraph (d), terms are defined as (ii) Specific health claims. A specific nature that, expressly or by implication, follows: health claim will not be considered suggest a relationship between the (i) Health-related statement means misleading if it is truthful and consumption of alcohol, malt beverages, any statement related to health and adequately substantiated by scientific or or any substance found within the malt includes statements of a curative or medical evidence; sufficiently detailed beverage, and health benefits or effects therapeutic nature that, expressly or by and qualified with respect to the on health. The term includes both implication, suggest a relationship categories of individuals to whom the specific health claims and general between the consumption of alcohol, claim applies; adequately discloses the references to alleged health benefits or distilled spirits, or any substance found health risks associated with both effects on health associated with the within the distilled spirits, and health moderate and heavier levels of alcohol consumption of alcohol, malt beverages, benefits or effects on health. The term consumption; and outlines the or any substance found within the malt includes both specific health claims and categories of individuals for whom any beverage, as well as health-related general references to alleged health levels of alcohol consumption may directional statements. The term also benefits or effects on health associated cause health risks. This information includes statements and claims that with the consumption of alcohol, must appear as part of the specific imply that a physical or psychological distilled spirits, or any substance found health claim and in a manner as sensation results from consuming the within the distilled spirits, as well as prominent as the specific health claim. malt beverage, as well as statements and health-related directional statements. (iii) Health-related directional claims of nutritional value (e.g., The term also includes statements and statements. A statement that directs statements of vitamin content). claims that imply that a physical or consumers to a third party or other Statements concerning caloric, psychological sensation results from source for information regarding the carbohydrate, protein, and fat content consuming the distilled spirits, as well effects on health of distilled spirits or do not constitute nutritional claims as statements and claims of nutritional alcohol consumption is presumed about the product. value (e.g., statements of vitamin misleading unless it— (ii) Specific health claim is a type of content). Statements concerning caloric, (A) Directs consumers in a neutral or health-related statement that, expressly carbohydrate, protein, and fat content other non-misleading manner to a third or by implication, characterizes the do not constitute nutritional claims party or other source for balanced relationship of the malt beverage, about the product. information regarding the effects on alcohol, or any substance found within (ii) Specific health claim is a type of health of distilled spirits or alcohol the malt beverage, to a disease or health- health-related statement that, expressly consumption; and related condition. Implied specific (B)(1) Includes as part of the health- or by implication, characterizes the health claims include statements, related directional statement, and in a relationship of the distilled spirits, symbols, vignettes, or other forms of manner as prominent as the health- alcohol, or any substance found within communication that suggest, within the related directional statement, the the distilled spirits, to a disease or context in which they are presented, following disclaimer: ‘‘This statement health-related condition. Implied that a relationship exists between malt should not encourage you to drink or specific health claims include beverages, alcohol, or any substance increase your alcohol consumption for statements, symbols, vignettes, or other found within the malt beverage, and a health reasons;’’ or disease or health-related condition. forms of communication that suggest, (2) Includes as part of the health- (iii) Health-related directional within the context in which they are related directional statement, and in a statement is a type of health-related presented, that a relationship exists manner as prominent as the health- statement that directs or refers between distilled spirits, alcohol, or any related directional statement, some consumers to a third party or other substance found within the distilled other qualifying statement that the source for information regarding the spirits, and a disease or health-related appropriate TTB officer finds is effects on health of malt beverage or condition. sufficient to dispel any misleading alcohol consumption. (iii) Health-related directional impression conveyed by the health- statement is a type of health-related related directional statement. (2) Rules for labeling. (i) Health- statement that directs or refers related statements. In general, labels consumers to a third party or other * * * * * may not contain any health-related source for information regarding the PART 7—LABELING AND statement that is untrue in any effects on health of distilled spirits or ADVERTISING OF MALT BEVERAGES particular or tends to create a alcohol consumption. misleading impression as to the effects (2) Rules for advertising. (i) Health- 7. The authority citation for 27 CFR on health of alcohol consumption. TTB related statements. In general, Part 7 continues to read as follows: will evaluate such statements on a case- advertisements may not contain any by-case basis and may require as part of Authority: 27 U.S.C. 205. health-related statement that is untrue the health-related statement a in any particular or tends to create a 8. Section 7.29 is amended by revising disclaimer or some other qualifying misleading impression as to the effects paragraph (e) to read as follows: statement to dispel any misleading

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impression conveyed by the health- paragraph (e), terms are defined as related statement. Such disclaimer or related statement. follows: other qualifying statement must appear (ii) Specific health claims. (A) TTB (i) Health-related statement means as prominent as the health-related will consult with the Food and Drug any statement related to health and statement. Administration (FDA), as needed, on the includes statements of a curative or (ii) Specific health claims. A specific use of a specific health claim on a malt therapeutic nature that, expressly or by health claim will not be considered beverage label. If FDA determines that implication, suggest a relationship misleading if it is truthful and the use of such a labeling claim is a drug between the consumption of alcohol, adequately substantiated by scientific or claim that is not in compliance with the malt beverages, or any substance found medical evidence; sufficiently detailed requirements of the Federal Food, Drug, within the malt beverage, and health and qualified with respect to the and Cosmetic Act, TTB will not approve benefits or effects on health. The term categories of individuals to whom the the use of that specific health claim on includes both specific health claims and claim applies; adequately discloses the a malt beverage label. general references to alleged health health risks associated with both (B) TTB will approve the use of a benefits or effects on health associated moderate and heavier levels of alcohol specific health claim on a malt beverage with the consumption of alcohol, malt consumption; and outlines the label only if the claim is truthful and beverages, or any substance found categories of individuals for whom any adequately substantiated by scientific or within the malt beverage, as well as levels of alcohol consumption may medical evidence; sufficiently detailed health-related directional statements. cause health risks. This information and qualified with respect to the The term also includes statements and must appear as part of the specific categories of individuals to whom the claims that imply that a physical or health claim and in a manner as claim applies; adequately discloses the psychological sensation results from prominent as the specific health claim. health risks associated with both consuming the malt beverage, as well as (iii) Health-related directional moderate and heavier levels of alcohol statements and claims of nutritional statements. A statement that directs consumption; and outlines the value (e.g., statements of vitamin consumers to a third party or other categories of individuals for whom any content). Statements concerning caloric, source for information regarding the levels of alcohol consumption may carbohydrate, protein, and fat content effects on health of malt beverage or cause health risks. This information do not constitute nutritional claims alcohol consumption is presumed must appear as part of the specific about the product. misleading unless it— health claim. (ii) Specific health claim is a type of (A) Directs consumers in a neutral or (iii) Health-related directional health-related statement that, expressly other non-misleading manner to a third statements. A statement that directs or by implication, characterizes the party or other source for balanced consumers to a third party or other relationship of the malt beverage, information regarding the effects on source for information regarding the alcohol, or any substance found within health of malt beverage or alcohol effects on health of malt beverage or the malt beverage, to a disease or health- consumption; and alcohol consumption is presumed related condition. Implied specific misleading unless it— health claims include statements, (B)(1) Includes as part of the health- (A) Directs consumers in a neutral or symbols, vignettes, or other forms of related directional statement, and in a other non-misleading manner to a third communication that suggest, within the manner as prominent as the health- party or other source for balanced context in which they are presented, related directional statement, the information regarding the effects on that a relationship exists between malt following disclaimer: ‘‘This statement health of malt beverage or alcohol beverages, alcohol, or any substance should not encourage you to drink or consumption; and found within the malt beverage, and a increase your alcohol consumption for (B)(1) Includes as part of the health- disease or health-related condition. health reasons;’’ or related directional statement the (iii) Health-related directional (2) Includes as part of the health- following disclaimer: ‘‘This statement statement is a type of health-related related directional statement, and in a should not encourage you to drink or to statement that directs or refers manner as prominent as the health- increase your alcohol consumption for consumers to a third party or other related directional statement, some health reasons;’’ or source for information regarding the other qualifying statement that the (2) Includes as part of the health- effects on health of malt beverage or appropriate TTB officer finds is related directional statement some other alcohol consumption. sufficient to dispel any misleading qualifying statement that the (2) Rules for advertising. (i) Health- impression conveyed by the health- appropriate TTB officer finds is related statements. In general, related directional statement. sufficient to dispel any misleading advertisements may not contain any * * * * * impression conveyed by the health- health-related statement that is untrue Signed: February 13, 2003. related directional statement. in any particular or tends to create a Arthur J. Libertucci, * * * * * misleading impression as to the effects Administrator. 9. Section 7.54 is amended by revising on health of alcohol consumption. TTB February 25, 2003, paragraph (e) to read as follows: will evaluate such statements on a case- by-case basis and may require as part of Timothy E. Skud, § 7.54 Prohibited statements. the health-related statement a Deputy Assistant Secretary, (Regulatory, * * * * * disclaimer or some other qualifying Tariff and Trade Enforcement). (e) Health-related statements. (1) statement to dispel any misleading [FR Doc. 03–4836 Filed 2–28–03; 8:45 am] Definitions. When used in this impression conveyed by the health- BILLING CODE 4810–31–P

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