Testimony Before the Bureau of Alcohol, Tobacco and Firearms Concerning Health Claims and Health-Related Statements for Alcoholic Beverages
George A. Hacker, Director, Alcohol
The Center for Science in the Public Interest (CSPI)1 is pleased to submit testimony before the Bureau of Alcohol, Tobacco and Firearms (ATF) concerning its proposal to amend regulations pertaining to health claims and health-related statements for alcoholic beverages.2 As a nonprofit health-advocacy organization, CSPI is extremely concerned about the possibility of allowing alcoholic-beverage producers to use health claims to promote drinking. Likewise, we have become increasingly skeptical of the current use of "directional" messages on wine labels. Therefore, our testimony today urges ATF to take all necessary steps to ensure that all health claims and directional statements made by alcoholic-beverage producers are nonmisleading and carefully regulated to avoid consumer deception.
Alcohol is the third leading cause of death in the United States. Alcohol consumption is associated with cirrhosis, numerous cancers, hemorrhagic stroke, birth defects, injuries, violence, poisoning, and suicide. Even the moderate use of alcohol has risks for some drinkers. Alcohol's anti-clotting ability, while potentially protective against heart attacks, may increase the risk of hemorrhagic stroke.3 Alcohol may interact harmfully with more than one thousand medications and worsen advanced heart failure. Studies show that moderate alcohol consumption can increase the risk of congenital problems, migraine headaches, seizures, poor sleep, rectal cancer,4 esophageal cancer,5 and breast cancer.6
We do not dispute the studies that associate moderate drinking with a reduced risk of heart disease in some groups of people. However, those studies simply do not diminish the fact that alcohol is a potentially dangerous, potentially addictive, and potentially deadly drug, and that any positive health statement about such a drug must be presented in a balanced and nonmisleading manner. Permitting alcohol producers to tout the possible health benefits of alcohol consumption while ignoring the panoply of serious risks would be inherently misleading, irresponsible, and indefensible. ATF should continue to reject all unqualified and unbalanced health claims for alcoholic beverages.
Allowing unqualified health claims for alcohol would contradict congressional policy and conflict with the regulatory schemes of the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). In fact, FDA's letter in response to ATF's health claim proposal (a part of the record of these proceedings) states: "FDA believes it is imperative that you [ATF] regulate these claims in a manner consistent with the provision of the Federal Food, Drug, and Cosmetic Act (FFDC Act) to ensure the meaningful and nonmisleading use of such claims."7
As the FDA letter stated, the Nutrition Labeling and Education Act (NLEA) prohibits health claims for a food that contains any nutrient that increases to persons in the general population the risk of diet-related disease or health-related conditions (unless FDA has determined by regulation that such claim would assist consumers in maintaining healthy dietary practices).8 For example, even though whole milk is an excellent source of calcium, milk producers are barred from making a health claim concerning osteoporosis because whole milk contains too much saturated fat, consumption of which increases the risk of coronary heart disease.
The FDA letter also noted that FDA regulations establish a minimum nutrient level criterion to preclude health claims on foods that do not make a significant nutritional contribution to the diet.9 This criterion requires foods bearing a health claim to be a good source (i.e., at least 10 percent of the daily value) of at least one of six nutrients required to be declared in the nutrition information label (i.e., vitamin A, vitamin C, calcium, iron, protein, or dietary fiber).10 The FDA does not believe that alcoholic beverages meet this standard. To allow unqualified health claims for alcohol, America's most devastating drug, while health claims for foods such as whole milk are prohibited, would be indefensible and would make a mockery of the federal government's health-claim regime.
Although we strongly oppose the use of health claims for alcoholic beverages, we could nonetheless conceive the permissibility of certain claims if they were well-supported, pre-approved, meaningfully and clearly qualified, and balanced. Accordingly, we recommend, at a minimum, that ATF establish the following seven requirements to minimize the potential for consumer deception.
1. Any claim promoting the potential health benefits of alcohol consumption should be accompanied by an equally prominent statement warning consumers of the potential health risks of alcohol consumption. In order for consumers to make an educated decision about whether or not to drink for health reasons, they must be fully and meaningfully informed about all of the potential health consequences. We urge ATF to not only require such disclosures for any proposed health claim, but also to conduct empirical studies to ascertain if such disclosures are even sufficient -- if consumers would actually read the disclosures and be fully informed by them. If studies reveal that disclosures are not adequate, ATF should deem the proposed claim misleading and prohibit it entirely.
2. If a health claim does not apply universally to all segments of the population, it must be carefully worded so that it is directed only to those for whom the claim applies. For example, a health claim concerning lowered coronary heart disease risk should be directed only to men over 45 and post-menopausal women. The groups of people that should abstain from alcohol should also be clearly identified: children and adolescents, people who cannot control their drinking, women trying to conceive or who are pregnant, drivers and persons who perform tasks that require attention or skill, and individuals using prescription drugs or over-the-counter medication. We also recommend that all health claims contain a special cautionary note to elderly consumers warning them of the heightened risks that they face when consuming alcohol.
3. All health claims should be supported by "significant scientific agreement" among qualified experts and by the "totality of publicly available evidence," as the FDA requires for health claims for foods.11 This evidence should include data from well-designed studies conducted in accordance with recognized scientific procedures and principles. It is especially important that health claims be supported by a very high standard of evidence because of the numerous and serious health risks that are associated with alcohol consumption. Health claims based on preliminary studies should never be allowed, even if they are accompanied by explanatory disclaimers.12
4. All health claims should be pre-approved by the FDA to make it easier to prohibit poorly substantiated or improperly worded claims before they actually appear on labels. Prohibiting claims after consumers have already read them does not remedy any lingering misperceptions caused by the claim. Since FDA officials possess the necessary scientific and public health expertise, as well as relevant experience in evaluating health claims for foods, they would be better suited to evaluate health claims for alcoholic beverages than the BATF.
5. Health claims should not use vague recommendations, such as "responsible" or "moderate" drinking since most people do not know what "moderate" drinking is. Rather, they should state exactly the minimum alcohol consumption (expressed in number of drinks) that confers the desired health effect. The Substance Abuse and Mental Health Services Administration (SAMHSA) conducted a study of a potential wine label referring to "moderate consumption."13 The study concluded that the word "moderate" has virtually no meaning, and found that people's conception of moderation ranged from "1 or 2 drinks" to "a bottle of wine in an evening."
6. Health claims should be worded and displayed in a manner that does not overshadow, contradict, or undermine the government warning label. For example, the claim should appear in the same type size and style as the government warning label, and should not contain any claim that contradicts any of the statements in the warning label.
7. Health claims and health-related statements should be held to the same high regulatory standard for both advertisements and labels to present consumers with consistent health messages and minimize potential confusion.
We would now like to discuss the so-called directional "health-effects" statements that are currently allowed on some wine labels. Those statements, which encourage consumers to consult their family doctors or the Dietary Guidelines to learn about the "health effects of wine consumption," are problematic for several reasons.
First, referring consumers to a government publication which offers limited, balanced information about alcohol consumption is only credible if there is a reasonable likelihood that such referral will in fact result. To date, there has been no research to confirm that such directional referrals actually result in substantial numbers of consumers requesting and reading the government publication, or consulting with a physician.
Second, even if consumers actually consulted their family doctors, or obtained and read a copy of the Dietary Guidelines, those sources may be inadequate to fully inform consumers about the health effects of alcohol consumption. The 1995 Dietary Guidelines does not -- nor was it designed to -- provide a complete statement of the risks and benefits of alcohol consumption. The current Dietary Guidelines does not even mention some of the most troubling risks of moderate alcohol consumption, such as the increased risk of breast cancer. Similarly, although some physicians may be able to educate their patients about the risks and benefits of alcohol consumption, many are unlikely to do so unless patients actually ask for such information. For a variety of reasons, such questions rarely get asked. Most physicians receive little training in this area and may not keep up with the latest research. Physicians, who may or may not know their patients well, are also unlikely to have the time necessary to adequately explain whether moderate alcohol consumption is appropriate for their patients. Studies also indicate that physicians do not pay much attention to their patients' alcohol use, and suggest that physicians would therefore be ill-equipped to advise their patients whether moderate drinking is appropriate. In one study of a large primary care clinic, physicians detected alcohol problems in fewer than half of their patients with current alcohol abuse or dependence. In another study, only 25% of patients found to be dependent on alcohol were warned of the health risks of drinking by their health care provider or advised to reduce or stop using alcohol, and fewer than 1 in 10 were referred for alcohol treatment.14
Third, a reference to the "health effects of wine consumption" offers no useful information. It is likely that consumers interpret the phrase "health effects" as "health benefits" and that the statement reinforces existing inaccurate knowledge about the health benefits of alcohol consumption, as spread through the media and the wine industry's misleading publicity campaign.
For the above reasons, we urge ATF to conduct empirical studies to determine how consumers actually interpret those directional "health-effects" statements it has already approved. If consumers construe them as statements implying the health benefits of alcohol consumption, they must be held to the same high regulatory standard that we have recommended for health claims.15 In addition, we urge ATF to maintain its moratorium on approving all future "directional" claims unless and until empirical studies show that such claims are not misleading and do not imply health benefits.
In closing, we would like to reiterate CSPI's strong opposition to alcoholic-beverage producers' use of health claims and directional statements to promote drinking. We urge ATF to carefully consider our recommendations. Alcohol producers should be required either to tell the whole story about alcohol or be prevented from hawking America's costliest and most devastating drug as the ultimate health potion.
1. The Center for Science in the Public Interest (CSPI) is a nonprofit health-advocacy organization based in Washington, D.C. that focuses on food safety and alcoholic-beverage issues. It is largely supported by the more than one million subscribers to its Nutrition Action Healthletter. CSPI led efforts to win passage of the law requiring warning labels on alcoholic beverages.
2. Health Claims and Other Health-Related Statements in the Labeling and Advertising of Alcohol Beverages, 64 Fed. Reg. 57,413 (1999).
3. M.J. Stampfer et al., A Prospective Study of Moderate Alcohol Consumption and the Risk of Coronary Disease and Stroke in Women. 319 New Eng. J. Med. 267 (1988).
4. National Institute on Alcohol Abuse and Alcoholism, Moderate Drinking, 6 Alcohol Alert (1992).
5. G. Launoy et al., Alcohol, Tobacco and Oesophageal Cancer: Effects of the Duration of Consumption, Mean Intake and Current and Former Consumption, 75 British Journal of Cancer 1389 (1997); W.J. Blot, Esophageal Cancer Trends and Risk Factors, 21 Seminars in Oncology 403 (1994).
6. S.A. Smith-Warner et al., Alcohol and Breast Cancer in Women: A Pooled Analysis of Cohort Studies, 279 JAMA 535 (1998); J.F. Viel et al., Alcoholic Calories, Red Wine Consumption and Breast Cancer Among Premenopausal Women, 13 European Journal of Epidemiology 639 (1997); M. Mezzetti et al., Population Attributable Risk for Breast Cancer: Diet, Nutrition, and Physical Exercise, 90 Journal of the National Cancer Institute 389 (1998); S.J. Bowlin et al., Breast Cancer Risk and Alcohol Consumption: Results from a Large Case-Control Study, 28 International Journal of Epidemiology 915 (1997); C.A. Swanson et al., Alcohol Consumption and Breast Cancer Risk Among Women Under Age 45 Years, 8 Epidemiology 231 (1997).
7. Letter from Margaret M. Dotzel, Acting Associate Commissioner for Policy, U.S. Food and Drug Administration to Chief, Regulatory Division, Bureau of Alcohol, Tobacco, and Firearms (Feb. 22, 2000).
8. 21 U.S.C.§ 343(r)(3)(A)(ii).
9. 21 C.F.R. § 101.14(e)(6) (1999).
10. FDA may grant an exception to this requirement as part of rulemaking to establish a health claim. See, e.g., 61 Fed. Reg. 43,433 (1996) (exempting sugar alcohols from the requirements of 21 C.F.R. § 101.14(e)(6)).
11. 21 C.F.R. § 101.14(c) (1999).
12. Although the U.S. Court of Appeals for the D.C. Circuits recently held that claims that do not meet the significant scientific agreement standard may be allowed if they include a disclaimer, this holding applies only to claims for dietary supplements. Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999).
13. Lewis D. Eigen et al., Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention, The Effect of Wine Labels on Public Perception, PHD752 (1998).
14. See J. K. Ockene, et al., Provider Training for Patient-Centered Alcohol Counseling in a Primary Care Setting, 157 Arch. Intern. Med. 2334 (1997).
15. As the FDA has stated, "[i]mplied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition." 21 C.F.R. § 101.14(a)(1) (1999).