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x Comments by W. Kip Viscusi on FDA Notice of Findings, "Regulations • Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents: Findings of the Focus Group Testing of Brief Statements for Cigarette Advertisements," 60 Fed. Reg. 61,670-79 (Dec. 1, 1995). ~George G. Allen Professor of Economics, Department of Economics, Duke University, Durham, NC 27708-0097, phone 919-660-1833, fax 919-684-8974.

• • Backaround I have been asked by Covington & Burling, which represents the Tobacco Institute, to prepare comments on the FDA notice of December 1, 1995, pertaining to the sale and distribution of-cigarettes and smokeless tobacco. I am currently the George G: Allen Professor of Economics at Duke University and have published 15 books and over 150 articles, many of which deal with the issues addressed in this rulemaking. For example, many of these books focus on risk perceptions and product safety. One of my recent books and several recent articles focus on cigarette smoking. My books have won three successive book of the year awards of the American Risk and Insurance Association. I am also the founding Editor of the Journal of Risk and Uncertainty and currently serve on seven other editorial boards, including the American Economic Review. An additional summary of my background and my C.V. and bibliography are appended to this statement. Overview The FDA notice of December 1, 1995, arises out of the Agency's proposal to require an additional warning message on cigarette advertising to help discourage smoking by persons under the age of 18. In my comments, I address three ways in which FDA's proposal is seriously flawed. First, the focus group fmdings are incapable of demonstrating that the proposed warnings would advance the Agency's goal, because focus group studies are merely preliminary steps to scientifically valid testing of the effects of a hazard warning and cannot by themselves serve as a test of any hypothesis about these effects. Second, independently of the methodological defects in FDA's focus group approach, there is no reason to believe that any additional warnings about the risks of smoking could achieve FDA's goal of reducing youth smoking by 50 percent, because youths already overestimate the health risks of smoking. Third, FDA's warnings that the -2-.

s • s • teenagers in the focus groups seemed to favor may have unintended adverse consequences -- on youth smoking rates in particular, and on the development of a consistent hazard warning vocabulary in general. The Focus Group Approach The foundation of the FDA notice is based almost entirely on results of focus groups undertaken with samples of 12- to 17-year-olds by a survey research firm, Macro International. l Focus groups are, of course, a frequent part of survey design. However, the purpose of focus groups is not to test hypotheses, but rather to serve an exploratory role in, for example, developing question language for a survey. It is typically a preliminary stage of the survey design that takes place before pretesting of a survey instrument and before undertaking a survey that would have any scientific validity. Focus group reports are not a substitute for a scientific study or a controlled experiment that analyzes hazard warning labels; the entire character of the focus groups is simply not designed to make it possible to undertake scientific hypothesis tests. Indeed, the report that Macro International prepared for FDA repeatedly emphasizes the limitations inherent in focus group testing as a predictor of the effects of hazard warnings and explicitly cautions that the results are merely preliminary to further, scientifically valid studies: "This study cannot be considered reliable or valid in a statistical sense since the recruiting of participants cannot be replicated, nor can the moderator ask the same questions of other respondents. Certain biases are inherent in this type of study and are stated here to remind the reader that focus group data cannot be projected to any universe of individuals. 1 As noted in the background appendix, I have served as a consultant to Macro International on warnings issues. 3

9 • • • Finally, the reader is reminded that this report is intended primarily to clarify cloudy issues and point the direction for future research, and that data here cannot be projected to a universe of similar respondents. " 60 Fed. Reg. 61,672. Although these caveats stress the limitations of the population mix, the entire focus group process lacks solid foundation. The contrast between the approach that FDA undertook in this instance and the approach that I have taken on behalf of EPA reflects the differences between a focus group and a scientific study. In our studies of warnings for EPA, which were subsequently published as books by Harvard University Press and MIT Press,2 Wesley Magat and I also engaged in a pretesting phase. However, the results of this pretesting were then used in conjunction with evidence from the literature on warnings to design a series of.experimental treatments, one of which involved no risk information, and others of which explored different types of warning content and format in providing the warning message. Participants in our study answered the questionnaire giving detailed demographic information, making it possible to statistically control for individual differences. Moreover, this information served to establish a baseline with respect to respondents' risk beliefs and other aspects of their behavior. Respondents were then provided with the hazard warning that was pertinent for their particular experimental manipulation. The effect of the experimental treatment was assessed by investigating how risk perceptions and various measures of precautions are altered as a result of different hazard warnings. Because precautionary intentions may not always correspond with actual behavior, it is important to check the validity of the experimental design. We established this 2 W. Kip Viscusi and Wesley Magat. Learning About Risk: Consumer and Worker Responses to Hazard Information Cambridge: Harvard University Press, 1987 and Wesley Magat and W. Kip Viscusi, Informational Approaches to Regulations, Regulation of Economic Activity Series No. 19, Cambridge: MIT Press, 1992. 4

0 • 0 validity through a separate survey involving a different sample in which precautions were assessed for a product with a hazard warning label that directly corresponded to the risk information content and format of one of the labels used as an experimental treatment. The failure to find any significant differences in behavior between actual labels on the market and the experimental analog suggested that the study did a meaningful job of assessing how warnings would in fact influence behavior. Using these results, we estimated statistically the effect of hazard warnings on risk beliefs and various measures of precautionary behavior. Thus, it was possible to test scientifically whether in fact warnings improved risk judgments and whether they affected behavior. The purpose of hazard warnings is to promote sensible choices, and as a result it is essential to ascertain whether the information is being correctly understood and whether it produces accurate risk assessments and appropriate risk-averting decisions. In contrast, the FDA study went no further than the pretesting phase. FDA does not contemplate conducting the additional, research studies that FDA's own consultants have warned should follow the focus group studies. Instead, FDA states that it "will use the report, as well as comments submitted on the report, to determine the design, format, and content of the brief statement when preparing a fmal rule." 60 Fed. Reg. 61,670. FDA appears to have accepted the opinions of select groups of teenagers about the effects of the Agency's proposed warnings as valid data even though they have not been validated by scientifically rigorous testing. The design of hazard warnings is not an exercise that can be delegated to amateurs or, for that matter, to teenagers. To ask children aged 12 to 17 to, in effect, design a hazard warnings policy for cigarettes is completely irresponsible. FDA has ignored the considerable volume of academic literature that has developed guidelines for hazard ~ O warnings policy that could have assisted the Agency in evaluating the design of C~ ~ C ~ W -5- ~ GO

• • • meaningful and effective warnings. This literature goes beyond the many books and articles by myself and also includes a wide range of other studies from researchers in a variety of disciplines.3 One of the conclusions that FDA could have drawn from this literature is that, in any assessment of the efficacy of warnings based on responses by a sample of representative consumers, such as teenagers, it is essential to design the study and undertake it in a manner that utilizes their responses to test scientifically the efficacy of warnings rather than, in effect, delegating the responsibility of making policy decisions to children. FDA's approach represents a departure from the scientific literature in that it included no substantive testing of the efficacy of warnings. SmokinQ Risk Beliefs The underlying assumption that provides the impetus for FDA's proposal to require additional warnings is that youths are not aware of the risks of smoking or do not sufficiently appreciate the seriousness of those risks. If this assumption is incorrect, then the additional warnings that FDA has proposed will not achieve the Agency's goal of reducing underage smoking. Warnings can change behavior, but unlike regulations, warnings do not demand obedience under threat of sanctions but instead communicate information. It follows that warnings can only change behavior by providing relevant information of which an individual was previously unaware. Therefore, regulatory agencies should only use warnings in situations in which individuals are acting with inadequate information or in which there is substantial misinformation that the government is trying to correct. Warnings that instead attempt simply to browbeat individuals into changing their behavior will not be successful. O 3See not only the 1987 survey by the U.S. Department of Health & Human Services but ~ also the American Law Institute, Enterprise Responsibility for Personal Inj,ury-Reporters' ~ Study, Philadelphia: American Law Institute, 1991. © Qa c.~ -6- ~ co tc

• • Although underage smoking is a legitimate object of concern, inadequate risk perceptions are not its cause. Adolescents smoke not because they are unaware of, or underestimate, the risks; virtually all adolescents believe smoking is dangerous and start to smoke in spite of their beliefs about the hazards involved. Because the problem is not some lack of information or any defect of awareness, additional warnings can serve no purpose as educative tools and hence are unjustified. It is useful to review my published evidence on risk perceptions by those in younger age groups. Based on the most recent estimates of the lung cancer mortality risk to smokers from the data provided by the U.S. Surgeon General and the National Cancer Institute, I have estimated the lung cancer mortality risk to smokers as being .06-.13.4 This scientific evidence provides the reference point for assessing whether individuals' subjective risk perceptions are accurate. For all age groups, the overall assessed lung cancer risk is .43.5 Younger respondents do not assess the risk as being lower, as the FDA might lead us to believe; as it turns out, respondents aged 16-21 assess the lung cancer risk as being .49, and respondents aged 16-21 who smoke assess the lung cancer risk as being .45.6 These risk perceptions exceed those of adults and dwarf the estimated lung cancer risks associated with smoking. FDA apparently recognizes that underage smokers do not suffer from any lack of awareness of the risks of smoking. The Agency seeks to design new warnings that will 4 See page 70 of W. Kip Viscusi, Smoking: Making the Risky Decision New York: Oxford University Press, 1992. 5 See id. at 64. Alternative question wordings yielded stark results. In particular, results pertaining to assessments of the lung cancer mortality risk are similar to the assessed risk of lung cancer. More importantly, assessments of the overall smoking mortality risk are considerably greater than the assessed lung cancer risk. Whereas the assessed lung cancer risk was .43, the assessed total smoking mortality risk is .54. See id. at 77. Respondents view death from smoking as better than a 50/50 proposition. 6 See id. at 123. 7

! 0 • • "shout" at children, so to speak, to find ways not of imparting new information but of turning up the "volume" so that even the deafest youths will hear -- and act on -- the message. FDA's approach is reflected in the avowed intent of the focus group studies, which was to identify the message that the participants would find to be "most compelling. " 60 Fed. Reg. 61,670. The proposal by the youths who participated in the study that warnings might be given in bold letters, with neon print, and with jagged borders surrounding the warning, see 60 Fed. Reg. 61,674-75, is a reflection of the misguided intent of the entire exercise. The fact that the youths in the focus groups favor these design elements does not mean that they will be successful in changing behavior. Rather, this is simply a design that the focus group participants would like to look at!7 Aesthetically pleasing designs do not make warnings effective at changing behavior where there is no information deficit or misperception to correct.8 Counterproductive Effects Not only would additional warnings fail to reduce underage smoking, they might also have the unintended consequence of increasing smoking rates or promoting other 7 Several focus group participants clearly were more concerned with the aesthetics of FDA's warning designs than their efficacy. See, e. g. , Transcript of Focus Group Studies, November 9, 1995, 6:00 p.m., San Francisco, CA, at 66 ("MODERATOR DAVIS: But how about something like, you know, a different shape? Like this? PARTICIPANT: Oh, my God. PARTICIPANT: You need arrows. PARTICIPANT: That's really cool. That is super cool. MODERATOR DAVIS: Is that -- PARTICIPANT: The box and every -- PARTICIPANT: Flash neon pink, too. "); Transcript of Focus Group Studies, October 31, 1995, 6:30 p.m., Houston, TX, at 81 ("PARTICIPANT: Make it pretty or something. "); Transcript of Focus Group Studies, October 31, 1995, 4:30 p.m., Houston, TX, at 82 ("PARTICIPANT: (Inaudible.) Looks boring, but colors make it more exciting. "). 8 Indeed, aesthetics may work against the intended effects of a warning. Young children, for example, often find the skull and crossbones poison symbol to be an ZZd attraction rather than a deterrent. See Schiender K. "Prevention of Accidental Poisoning O through Package and Label Design," Journal of Consumer Research Vol. 4, September Cse 1977, pp. 66-74. © ~ W -8- ~ h~

• • • • • forms of risk-taking. FDA apparently has not considered all of the implications of the information that its proposed warnings would communicate. As the remarks of some of the focus group participants suggest, teenagers may interpret these warnings in ways that FDA did not anticipate. In view of teenagers' overassessment of smoking mortality risks, one wonders what will be the effect of the proposed FDA warning: "About 1 out of 3 kids who become smokers will die from their smoking. " This estimate is in line with my own published assessments of the total smoking mortality risk to smokers of .18-.36, though it is at the high end of my range.9 However, what is at issue here is not the accuracy of the statement but rather its effect on smoking risk perceptions. Youths and adults currently believe that the risk from smoking is considerably rg_eater than a probability of 1 out of 3. Thus, providing the information that 1 out of 3 kids will die from smoking may in fact reduce risk perceptions (and possibly increase smoking rates).10 A possible counterargument may be that at least this warning makes the information more precise and consequently more credible than would a possibly ambiguous subjective risk judgment. However, the role of ambiguity is a topic for which I have undertaken considerable research for EPA, particularly with respect to risks of cancer and other ambiguous risks regulated by that agency.11 In situations in which the 9 See page 70 of W. Kip Viscusi (1992). 10 Indeed, some focus group participants believed that some youths would interpret FDA's "About 1 out of 3 kids ..." warning to mean that two out of three kids could smoke without suffering increased mortality. See, e.Q., Transcript of Focus Group Studies, October 25, 1995, 6:30 p.m., Charlotte, NC, at 37 ("PARTICIPANT: Well, they' ll think, it won't happen to me, I' ll go ahead and do it anyway. They' ll think they' 1l be one of the two. PARTICIPANT: Yeah. "). 11 See, among my studies for EPA, W. Kip Viscusi, Wesley A. Magat, and Joel Huber, Communication of Ambiguous Risk Information," Theorv and Decision, Vol. 31, Nos. 2/3 (Sept./Nov. 1991) pp. 159-173 and also W. Kip Viscusi and Wesley A. Magat, "Bayesian Decisions with Ambiguous Belief Aversion, " Journal of Risk and Uncertainty, Vol. 5, No. 4 (Oct. 1992) pp. 371-387. 9

a • • • • • • • risk is ambiguous, the evidence shows that individuals are actually more reluctant to engage in the risky behavior than in situations in which the risk is precisely known. Thus, if the warning sharpens risk perceptions it will also encourage smoking rather than deter it. In each case the consequences are opposite those that FDA intends. If the warning indicates that one-third of all kids will die from smoking, how will adults assess the risk given this information? Since their period of exposure to the risk from cigarettes will be less than that for youths, will they assess their risk as being less than one-third? Because the adult population cannot be excluded from receiving a warning message that is included in cigarette advertising, one needs to be concerned not only with how the information will be processed by children but how it will be processed by adults as well. In the case of adults, the potential for erroneous interpretations with respect to the risk level for adults is particularly great. FDA must consider the effect of the warning on every potential smoking group that will be exposed to the warning message through advertising. Diminishing risk perceptions is not the only potentially counterproductive effect of FDA's contemplated actions. The proposed warning in which the risks of smoking are compared to a variety of other societal risks, such as those posed by AIDS and drunk driving, will tend to trivialize these risks in the view of the recipient of the warning. Providing comparative risk information always poses inherent difficulties, in part because it is predicated on the assumption that the reference point risk comparisons are well understood. If the respondent believes that the risks from smoking are not that great, will this then lead the recipient of the warning to dismiss other less well understood risks, such ` as -that of AIDS? Even if the respondent believes that the risks from smoking are great, the message that those risks are great compared to the risks of AIDS, etc., necessarily ~ 0 c.rc ~ ~ -10- ~ ci,D W

r • • diminishes those other risks.12 Ironically, the 1981 FTC Staff Report said that warnings should be personally relevant to the viewer, and not assert abstract propositions.13 "A is greater than B" is a paradigm of an abstract proposition. Warnings that cigarettes are akin to a drug may in fact make smoking more enticing and more adventuresome to the target teenage group. Cigarettes are much more readily accessible and less expensive than cocaine, marijuana, and other illegal drugs. Attaching the drug label to the smoking activity may give it an allure that smoking would not otherwise have had. Warnings that smoking is addictive also are potentially counterproductive. If youths have begun to experiment with cigarettes, it would be a mistake to give them a rationale for continuing by telling them they are addicted. Warnings regarding addiction may consequently deter people from quitting smoking once they have started, as the government has informed them that, once started, their smoking is beyond their control. These various difficulties may not all prove to be of great practical importance, though certainly some of them are likely to be pertinent. However, what they do 12 Indeed, one focus group participant believed that this warning fostered the impression that alcohol and drug use were a preferable alternative to tobacco use. See Transcript of Focus Group Studies, November 9, 1995, 6:00 p.m., San Francisco, CA, at 47-48 ("PARTICIPANT: These are really good except for the one about tobacco kills more each year then AIDS, alcohol, accidents, murders, suicides, illegal drugs, and fires, because then that's just endorsing safe sex, drinking and driving, killing people, jumping off a cliff, dealing drugs. MODERATOR DAVIS: Endorsing it in what way? PARTICIPANT: Well, it's saying, you know, well, hell, I'm going to go drink and, you know, snort some cocaine. MODERATOR DAVIS: Oh, I see what you're saying. So those are less risky than smoking. PARTICIPANT: Yeah. I mean, hell, my parents smoked cigarettes, but I'm going to be the one to say, you know, drink and drive or something. "). 13 See the Federal Trade Commission Staff Report on the Cigarette Advertising Investigation 4-15 to 4-16 (1981). -11-

0 • • • • • • highlight is the fact that designing and issuing hazard warnings is not a trivial and innocuous enterprise. Even well-intended hazard warnings can have adverse effects. The Hazard Warnings Vocabulary FDA's proposed warnings may also undermine the integrity of hazard warnings systems in general. The design of any warnings policy must ensure consistency with the generally accepted warnings vocabulary. FDA has, for example, been a leader in developing a highly structured hazard warnings vocabulary for patient package inserts. These warnings follow a standardized structure with respect to the provision of information regarding different kinds of properties of the drug, such as uses, contraindications, warnings, and other information. In addition, use of the human hazard signal words, such as "danger" and "warning, " as well as use of various mechanisms to alter the structure of the information presented, such as bold type and boxed warnings, also follow a rigid, standardized practice. The purpose of this standardization is to enable recipients of the information to make comparable judgments across products. If we use bold type and extremely prominent warnings for distant or contingent risks, then we have no available mechanism for communicating much more immediate perils. If we attempt to impress upon people the seriousness of distant or contingent risks by speaking about them in the terms ordinarily used to describe immediate perils, we necessarily undercut the • seriousness with which people will regard the immediate perils -- because people will come to think of them as being in the same class as the distant or contingent risks. The warnings policy favored by participants in the FDA-sponsored focus groups • fails to ensure consistency on a number of dimensions. First, the risk information . ~ provided (e.g., "Tobacco causes shortness of breath, coughing, yellow teeth, and p csc ~ ~ C..~ ~ -12- ~

• • • • • wrinkles. ") is without a source. Is this a message from the cigarette companies, the state legislature, Congress, the Surgeon General? From Mom and Dad? 14 Unattributed warnings are a departure from the current approach in which it is the Surgeon General providing the information, and the information provided has the weight of an official pronouncement. Is any change from that approach desirable? Does it devalue the Surgeon General's warnings? Is one to be credited but not the other? Does anyone seriously believe that adolescents will pay more attention to a statement that seems to come from a cigarette manufacturer than one that comes from the government, especially at a time when they are bombarded from all sides with the message that cigarette manufacturers are untrustworthy? FDA provides no scientifically rigorous evidence on how this aspect of the warning will affect its impact. Under FDA's proposal cigarette advertising would now have to include two warning messages. One warning message would be one of the standard rotating messages in which the Surgeon General is providing information. The second warning would presumably be a jagged-edged, boxed warning without any authorship. Given the juxtaposition of these two warnings, the potential for confusion is greater than in the normal warnings case in which no responsibility for the warning statement is assigned. Second, as was noted above, the contemplated hazard warnings may be in color and, based on the recommendations of the teenage respondents, possibly in neon. Color is sometimes used or required for warnings. However, use of color is restricted to very 14 This proposed warning -- an obvious effort to manipulate behavior by producing disgust or fear in the child -- is all too reminiscent of parental warnings regarding the perils of gumchewing and MTV. Such warnings are notoriously counterproductive. Indeed, some youths may regard the most dire warnings about the risks of smoking as a dare. During one of the focus group sessions, a participant raised this objection to the idea of using scare tactics along the lines of "you take a smoke, you'll die." See Transcript of Focus Group Studies, October 25, 1995, 6:30 p.m., Charlotte, NC, at 74 ("MODERATOR DAVIS: I mean, would that just -- maybe kids would read that and say, well, that's obviously not true so -- PARTICIPANT: Well, they might try just to see if it happens, you know. "). -13-

0 • • • unusual circumstances in which the risk is not only substantial but imminent. Bright orange is, for example, used in the standard industrial warning for TNT. However, this is a severe explosive risk that poses immediate catastrophic implications possibly to large numbers of individuals. Extremely potent carcinogens and other industrial chemicals do not receive the kind of neon treatment that is potentially envisioned for cigarettes. This aspect of the policy is clearly inconsistent with accepted warning practice across products. Such a reckless misuse of warning symbols and content could undermine the efficacy of warnings in other dimensions and for other activities for which we would like to promote sound risk-averting decisions.15 The jagged border around the warning is an unprecedented innovation and is subject to similar difficulties. All we know at this juncture is that the teenagers in the focus groups seem to like the jagged borders. Perhaps teenagers would be pleased to wear the design on tee-shirts.16 We do not really know, however, whether the presence of these jagged borders would have a statistically significant effect on either smoking risk perceptions or behavior. Moreover, using a jagged border here could dilute the impact of 15 The focus group studies' stated goal of identifying the "most compelling" warning message created an incentive for participants to favor extreme warning symbols and conventions. See Transcript of Focus Group Studies, November 9, 1995, 6:00 p.m., San Francisco, CA, at 74 ("MODERATOR DAVIS :... Would it matter if you had a different symbol? PARTICIPANT: Biohazard thing. MODERATOR DAVIS: Biohazard thing? PARTICIPANT: Yeah, like -- PARTICIPANT: You know, the triangle. PARTICIPANT: Yeah. PARTICIPANT: That would catch any kid's attention, really. "). 16 At least one participant in the focus group studies liked the jagged-edged border because it apparently reminded him of the artistic convention for depicting sound effects in comic books. See Transcript of Focus Group Studies, November 1, 1995, 6:30 p.m., Houston, TX, at 68 ("PARTICIPANT: Yeah, that's good. MODERATOR BRYANT: The jaggedy edges there? PARTICIPANT: Yeah. PARTICIPANT: Yeah, like Batman, you know. MODERATOR BRYANT: Like Batman? PARTICIPANT: Like, bang, you know. "). -14-

! ! • • ! • • merely boxing warnings for over-the-counter drugs, pesticides, and other hazardous products. The icon with an exclamation point surrounded by a triangle is subject to similar criticisms. There are two dimensions to the concerns with respect to being consistent with the hazard warnings vocabulary. First, at any point in time it is essential to maintain a consistent vocabulary so that individuals can distinguish relative riskiness across products or activities. Second, the teenagers of today who would be reading cigarette warnings in neon will eventually grow into the adults of the future, many of whom will work with hazardous chemicals on their jobs and almost all of whom will utilize potentially dangerous prescription drugs or household chemicals. If they were to become accustomed to extremely bold neon warnings of cigarette risks, then they would be likely to become passive with respect to many other classes of risk for which we would subsequently like to attract their attention. The prospective new cigarette warnings will devalue other important warnings both now and in the future. FDA should exercise restraint and forethought in developing new elements of a warnings vocabulary. In my past studies for the EPA, I have found that once warnings have reached a sufficient degree of readability, additional nuances such as large type and bolder boxing of the warning do not have a significant effect on the receipt and processing of the risk information. Although it may be that there is no constructive role that may be • played by the jagged edges, this format would disturb the accepted practices for presenting • warnings. Should, for example, all manufacturers of potentially hazardous products also add jagged edges to their warnings instead of simply boxing them in order to avert product liability suits? Will jagged edged boxes be used for the Physicians' Desk Reference listings? Once jagged edges become the norm, jagged edges will no longer be a ~ O distinctive feature so that the initial rationale for its distinctive character will be gone. Cit O ~ -15- ~ 00

a • r • • • • Conclusion FDA's proposal to require additional warnings on cigarette advertising is methodologically unsound, unlikely to prove effective and may produce unintended adverse consequences. The Agency developed its warnings policy without any regard for the usual scientific standards that are pertinent for work in the field and without considering the insights provided by the hazards warnings literature. Relying on experts and scientific evidence rather than conjectures by children to design warnings does not imply that the prospective recipients of the information should be excluded from the warnings design process. Indeed, my studies for EPA have drawn on hundreds of adults to assess the efficacy of different warnings. However, reputable academic journals simply would not treat as being scientifically valid a conclusion based solely on the results of focus group discussions. The Agency has not established the need for any additional warnings about the risks of smoking. There is simply no lack of information about the risks of smoking that an additional warning could remedy and therefore no reason to believe that the warning would reduce underage smoking. In light of this fact, it is all the more irresponsible of FDA to propose the warnings that it has. These warnings may have unintended adverse effects on behavior and may impair the integrity of the hazards warnings systems more 11 • • generally, all without generating any offsetting benefits in the form of reduced underage smoking. ~ O ~ O ~ -16- ~ ~ - ~ 0 ~

• • BACKGROUND APPENDIX Since the 1970s Professor W. Kip Viscusi has published academic studies on how people learn about risk and make subsequent choices under uncertainty. In part because of this research, he was asked in the early 1980s to settle the dispute between OSHA and OMB over the proposed OSHA hazard communication standard, which had been appealed to then Vice-President Bush. Both the New York Times and the Washington Post credited his analysis, which supported the regulation, with being the pivotal factor that led to the issuance of the regulation. l As a result of his involvement, he undertook a study of the effect of hazard warnings for workplace chemicals in four chemical plants, which was subsequently published in the 1984 American Economic Review.2 He has also been engaged in a series of studies for the U.S. Environmental Protection Agency to assist them in the design of hazard warnings for household chemicals and pesticides. These studies have been original scientific investigations involving experiments to assess the relative efficacy of different warning labels. The two studies based on this work, which he coauthored with Wesley A. Magat, were subsequently published as books by Harvard University Press and MIT Press.3 In addition to these two labeling studies, Professor Viscusi has also undertaken three controlled experimental field studies for the U.S. EPA on the effect of 1 For a detailed discussion of Professor Viscusi's involvement in the development of this regulation, see in particular the Washington Post Magazine June 9, 1985, pp. 11-13 and 36-41. 2 See W. Kip Viscusi and Charles O'Connor. "Adaptive Responses to Chemical Labeling: Are Workers Bayesian Decision Makers?" American Economic Review Vol. 74, No. 5 (Dec. 1984), pp. 942-956. 3 W. Kip Viscusi and Wesley Magat. Learning About Risk: Consumer and Worker Responses to Hazard Information Cambridge: Harvard University Press, 1987 and Wesley Magat and W. Kip Viscusi, Informational Approaches to Regulation, Regulation of Economic Activity Series No. 19, Cambridge: MIT Press, 1992.

• • communicating different kinds of risk information, particularly information dealing with ambiguous risks. He also served for EPA as a consultant/reviewer of their study of environmental tobacco smoke and continues to serve on two U.S. EPA Science Advisory Boards. Professor Viscusi has also published studies relating to cancer warnings on food and other aspects of hazard warning policy, served as the Associate Reporter for the American Law Institute Report on tort liability reform, for which he was a principal author of the hazard warning sections,4 and taught several continuing education courses to U.S. federal judges regarding the principles for judging the adequacy of effective warnings. His warnings work has also involved the design of hazard warnings for several nationally marketed consumer products, including the design of the current Dexatrim label. In connection with his work on alcoholic beverage warnings, Professor Viscusi was retained as one of the two principal consultants to Macro International -- the same consulting firm hired by FDA to prepare the study that served as the basis for the December 1, 1995 FDA notice. The Macro International report was subsequently issued by the U.S. Department of Health & Human Services as a critical overview of the warnings literature, where his work is discussed within the context of experimental approaches to warnings assessment.5 He has also testified before the U.S. Senate on alcoholic beverage warnings. 4 See Enterprise Responsibility for Personal Injury -- Reporters' Study, Vol. I: The Institutional Framework and Vol. II: Approaches to Legal And Institutional Change, Philadelphia: American Law Institute, 1991. 5 U.S. Department of Health and Human Services, Review of the Research Literature on the Effects of Health Warning Labels, Washington, D.C., June 1987. 2