Department of Health and Human Services

Vol. 76 Wednesday, No. 120 June 22, 2011

Part II

Department of Health and Human Services

Food and Drug Administration 21 CFR Part 1141 Required Warnings for Cigarette Packages and Advertisements; Final Rule

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DEPARTMENT OF HEALTH AND C. Consumers’ Lack of Knowledge of the C. Random Display and Rotation of HUMAN SERVICES Health Risks Warnings D. Larger, Graphic Warnings Communicate VII. Legal Authority and Responses to Food and Drug Administration More Effectively Comments E. Need To Refresh Required Warnings A. FDA’s Legal Authority III. FDA’s Selection of Color Graphic Images B. First Amendment Commercial Speech 21 CFR Part 1141 A. Methodology for Selecting Images Issues [Docket No. FDA–2010–N–0568] B. FDA’s Research Study C. Takings Under the Fifth Amendment 1. Study Design VIII. Implementation Date RIN 0910–AG41 2. Use of FDA’s Study Results in Selection IX. Federalism of Images X. Environmental Impact Required Warnings for Cigarette 3. Comments on FDA’s Research Study XI. Analysis of Impacts Packages and Advertisements C. Comments to the Docket A. Introduction and Summary 1. Comments Submitting Research on B. Comments on the Preliminary AGENCY: Food and Drug Administration, FDA’s Proposed Required Warnings Regulatory Impact Analysis HHS. 2. Other Comments 1. General D. Selected Images 2. Need for the Rule ACTION: Final rule. 1. ‘‘WARNING: Cigarettes are addictive’’ 3. Benefits 2. ‘‘WARNING: Tobacco smoke can harm 4. Costs SUMMARY: The Food and Drug your children’’ 5. Distributional Effects Administration (FDA) is amending its 3. ‘‘WARNING: Cigarettes cause fatal lung 6. Impact on Small Entities regulations to add a new requirement disease’’ C. Need for the Rule for the display of health warnings on 4. ‘‘WARNING: Cigarettes cause cancer’’ D. Benefits cigarette packages and in cigarette 5. ‘‘WARNING: Cigarettes cause strokes 1. Reduced Cigarette Smoking Rates advertisements. This rule implements a and heart disease’’ 2. Quantifying Benefits That Accrue to provision of the Family Smoking 6. ‘‘WARNING: Smoking during pregnancy Dissuaded Smokers 3. Reduced Fire Costs Prevention and Tobacco Control Act can harm your baby’’ 7. ‘‘WARNING: Smoking can kill you’’ 4. Summary of Benefits (Tobacco Control Act) that requires FDA 8. ‘‘WARNING: Tobacco smoke causes fatal E. Costs to issue regulations requiring color lung disease in nonsmokers’’ 1. Number of Affected Entities graphics, depicting the negative health 9. ‘‘WARNING: Quitting smoking now 2. Costs of Changing Cigarette Labels consequences of smoking, to accompany greatly reduces serious risks to your 3. Ongoing Costs of Equal and Random the nine new textual warning statements health’’ Display required under the Tobacco Control Act. 10. Image for Advertisements With a Small 4. Market Testing Costs Associated With The Tobacco Control Act amends the Surface Area Changing Cigarette Package Labels E. Non-Selected Images 5. Advertising Restrictions: Removal of Federal Cigarette Labeling and Noncompliant Point-of-Sale Advertising Advertising Act (FCLAA) to require 1. ‘‘WARNING: Cigarettes are addictive’’ 2. ‘‘WARNING: Tobacco smoke can harm 6. Government Administration and each cigarette package and your children’’ Enforcement Costs advertisement to bear one of nine new 3. ‘‘WARNING: Cigarettes cause fatal lung 7. Summary of Costs textual warning statements. This final disease’’ F. Cost-Effectiveness Analysis rule specifies the color graphic images 4. ‘‘WARNING: Cigarettes cause cancer’’ G. Distributional Effects that must accompany each of the nine 5. ‘‘WARNING: Cigarettes cause strokes 1. Tobacco Manufacturers, Distributors, new textual warning statements. and heart disease’’ and Growers 6. ‘‘WARNING: Smoking during pregnancy 2. National and Regional Employment DATES: This rule is effective September can harm your baby’’ Patterns 22, 2012. See section VIII of this 7. ‘‘WARNING: Smoking can kill you’’ 3. Retail Sector document, Implementation Date, for 8. ‘‘WARNING: Tobacco smoke causes fatal 4. Advertising Industry additional information. The lung disease in nonsmokers’’ 5. Excise Tax Revenues incorporation by reference of a certain 9. ‘‘WARNING: Quitting smoking now 6. Government-Funded Medical Services, publication listed in the rule is greatly reduces serious risks to your Insurance Premiums, and Social Security approved by the Director of the Federal health’’ H. International Effects I. Regulatory Alternatives Register as of September 22, 2012. 10. Image for Advertisements With a Small Surface Area 1. 24-Month Compliance Period FOR FURTHER INFORMATION CONTACT: IV. Comments Regarding Textual Warning 2. 6-Month Compliance Period Gerie Voss or Kristin Davis, Center for Statements 3. Alternative Graphic Images Tobacco Products, Food and Drug A. Changes to Textual Warning Statements 4. Summary of Regulatory Alternatives Administration, 9200 Corporate Blvd., B. Attribution to the Surgeon General J. Impact on Small Entities Rockville, MD 20850–3229, 877–287– C. Foreign Language Translations 1. Description and Number of Affected 1373, [email protected] or V. Description of the Final Rule Small Entities 2. Description of the Potential Impacts of [email protected]. A. Overview of the Final Rule B. Description of Final Regulations and the Final Rule on Small Entities SUPPLEMENTARY INFORMATION: Responses to Comments 3. Alternatives to Minimize the Burden on Small Entities Table of Contents 1. Section 1141.1—Scope 2. Section 1141.3—Definitions XII. Paperwork Reduction Act of 1995 I. Introduction 3. Section 1141.10—Required Warnings XIII. References A. Purpose and Overview 4. Section 1141.12—Incorporation by I. Introduction B. Background Reference of Required Warnings II. Need for the Rule and Responses to 5. Section 1141.14—Misbranding of A. Purpose and Overview Comments Cigarettes The Tobacco Control Act was enacted A. Cigarette Use in the United States and 6. Section 1141.16—Disclosures Regarding the Resulting Health Consequences Cessation on June 22, 2009, amending the Federal 1. Smoking Prevalence and Initiation in the VI. Comments Regarding Implementation Food, Drug, and Cosmetic Act (FD&C United States Issues Act) and FCLAA, and providing FDA 2. Health Consequences of Smoking A. Technical Issues Regarding Compliance with the authority to regulate tobacco B. Inadequacy of Existing Warnings B. Textual Statement Color Formats products (Pub. L. 111–31; 123 Stat.

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1776). Section 201 of the Tobacco evidence in the scientific literature that II. Need for the Rule and Responses to Control Act modifies section 4 of larger, graphic health warnings promote Comments FCLAA (15 U.S.C. 1333) to require that greater understanding of the health risks A. Cigarette Use in the United States the following nine new health warning of smoking and would help to reduce and the Resulting Health Consequences statements appear on cigarette packages consumption (see 75 FR 69524 at 69531 and in cigarette advertisements: through 69533). In proposing this 1. Smoking Prevalence and Initiation in • WARNING: Cigarettes are addictive regulation and preparing this final rule, the United States • WARNING: Tobacco smoke can we found substantial evidence In explaining the need for the harm your children indicating that larger cigarette health proposed rule, we provided information • WARNING: Cigarettes cause fatal warnings including a graphic lung disease in the NPRM on smoking prevalence component, like those being required in and initiation rates among adults and • WARNING: Cigarettes cause cancer this rule, would offer significant health children in the United States. As stated • WARNING: Cigarettes cause strokes benefits over the existing warnings. in the NPRM (75 FR 69524 at 69526), and heart disease Consistent with Executive Order 13563, • approximately 46.6 million U.S. adults WARNING: Smoking during this regulation is ‘‘based on the best (or 20.6 percent of the adult population) pregnancy can harm your baby available evidence’’ and has allowed • are cigarette smokers (Ref. 4). Moreover, WARNING: Smoking can kill you ‘‘for public participation and an open • almost half (46.3 percent) of youth in WARNING: Tobacco smoke causes exchange of ideas.’’ fatal lung disease in nonsmokers grades 9 through 12 in the United States • WARNING: Quitting smoking now B. Background have tried cigarette smoking, and 19.5 greatly reduces serious risks to your On November 12, 2010, as directed by percent of youth in grades 9 through 12 health. section 201 of the Tobacco Control Act are current cigarette smokers (Ref. 5 at Section 201 of the Tobacco Control and in the interest of public health, we p. 10). Smoking rates among U.S. adults Act also states that ‘‘the Secretary [of issued a proposed rule seeking to have shown virtually no change during Health and Human Services] shall issue modify the warnings that appear on the 5-year period from 2005 to 2009 regulations that require color graphics cigarette packages and in cigarette (Ref. 4), and smoking rates among U.S. depicting the negative health advertisements to include color graphic youth have not decreased from 2006 to consequences of smoking’’ to images depicting the negative health 2009 (Ref. 6). accompany the nine new health consequences of smoking; these images Furthermore, each year millions of warning statements. were proposed to accompany the nine U.S. adults and children become new As discussed in the preamble to the new textual warning statements set forth smokers. Data from the 2008 National proposed rule (75 FR 69524 at 69525, in section 201 of the Tobacco Control Survey on Drug Use and Health indicate November 12, 2010), cigarette smoking Act (see 75 FR 69524). The Agency that 2.4 million persons aged 12 or older kills an estimated 443,000 Americans received more than 1,700 comments to in the United States smoked cigarettes each year, most of whom began smoking the docket for the November 12, 2010, for the first time in the past 12 months when they were under the age of 18 notice of proposed rulemaking (NPRM) (Ref. 7 at p. 59). In addition, these data (Ref. 1). Tobacco use is the foremost on required warnings for cigarette indicate that almost 1 million preventable cause of premature death in packages and advertisements. Americans aged 12 or older started the United States, and has been shown Comments were received from cigarette smoking cigarettes daily within the past to cause cancer, heart disease, lung manufacturers, retailers and 12 months (Ref. 7 at p. 60). disease, and other serious adverse distributors, industry associations, In other words, approximately 6,600 health effects (Ref. 2). The U.S. health professionals, public health or people aged 12 or older in the United Government has a substantial interest in other advocacy groups, academics, State States become new cigarette smokers reducing the number of Americans, and local public health agencies, every day, and more than 2,500 particularly children and adolescents, medical organizations, individual individuals become new daily cigarette who use cigarettes and other tobacco consumers, and other submitters. These smokers every day (Ref. 7 at pp. 59–60). products in order to prevent the life- comments are summarized and Moreover, nearly 4,000 of the people threatening health consequences responded to in the relevant section(s) who become new cigarette smokers associated with tobacco use (section of this document. Similar comments are every day and nearly 1,000 of the 2(31) of the Tobacco Control Act). grouped together by the topics individuals who become new daily Although FCLAA has required the discussed or the particular portions of cigarette smokers every day are children inclusion of textual health warnings on the NPRM or codified language to which under the age of 18 (Ref. 7 at pp. 59– cigarette packages and in cigarette they refer. 60). These statistics for youth smokers advertisements for many years, there is To make it easier to identify are particularly concerning, as studies considerable evidence, which was comments and FDA’s responses, the suggest that the age people start presented in the preamble to the word ‘‘Comment,’’ in parenthesis, smoking can greatly influence how proposed rule (75 FR 69524 at 69529 appears before the comment’s much they smoke per day and how long through 69531) and is discussed in description, and the word ‘‘Response,’’ they smoke, which in turn influences section II.B of this document, that the in parenthesis, appears before FDA’s their risk of tobacco-related disease and existing cigarette health warnings are response. Each comment is numbered to death (Refs. 8, 9, and 10). given little attention or consideration by help distinguish among different FDA received many comments that viewers. A 2007 report from the comments. Similar comments are were strongly supportive of the Institute of Medicine (IOM) described grouped together under the same proposed rule, some of which provided the warnings as ‘‘invisible’’ (Ref. 3), and comment number. The number assigned data and information consistent with found that they fail to communicate to each comment is purely for that in the NPRM regarding cigarette use relevant information in an effective way. organizational purposes and does not prevalence and initiation in the United The warnings currently in use in the signify the comment’s value or States (75 FR 69524 at 69526 through United States also fail to include any importance or the order in which it was 69527). Many of these comments also graphic component, despite the received. stated that smokers would be more

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likely to quit smoking and that socioeconomic status. For example, estimated $1 billion annually in health nonsmokers would be less likely to start prevalence data from 2009 for current care and lost productivity (Ref. 14). The smoking if cigarette advertisements and U.S. adult cigarette smokers indicate comment also referred to evidence packages display, visually and that, among racial/ethnic groups, adults suggesting the tobacco industry has graphically, the health effects of reporting multiple races had the highest targeted military members and fought cigarettes. Most of these comments smoking prevalence (29.5 percent), efforts to reduce tobacco product expressed a belief that the required followed by American Indians/Alaska consumption by military personnel, and warnings would help reduce the Natives (23.2 percent) (Ref. 4). We also indicated that the proposed rule is an existing and future use of cigarettes. agree that economically disadvantaged important step in protecting military Some comments that were supportive of populations have higher smoking members from the health harms of the proposed rule discussed the prevalence rates. For example, data from cigarette use and will likely decrease smoking prevalence and initiation rates 2009 indicate that the prevalence of cigarette use among military personnel. in the United States in particular current smoking was higher among U.S. (Response) We agree that members of populations. These comments, and adults living below the Federal poverty the U.S. military have higher smoking FDA’s responses, are summarized in the level (31.1 percent) than among those at prevalence rates than the general following paragraphs. or above this level (19.4 percent) (Id.). population; approximately 20.6 percent (Comment 1) Multiple comments We have selected required warnings that of the U.S. adult population smoke indicated that people with less will help effectively convey the negative cigarettes, while data from 2008 indicate education and lower incomes have health consequences of smoking to a that 31 percent of active duty military higher smoking prevalence rates in wide range of population groups, personnel smoke cigarettes (Ref. 15). We general. One comment from a health including different racial and ethnic agree that the required warnings will care association indicated that women groups and different socioeconomic help convey information about various of low educational background have groups, and that can help both to health risks of smoking to a wide range higher smoking prevalence rates and discourage nonsmokers from initiating of individuals, including members of that many of these women still are not cigarette use and to encourage current the U.S. military and veterans who aware of cigarettes’ impact on life smokers to consider quitting. For began smoking while in military service, expectancy, heart disease, and additional information regarding our and that the required warnings will pregnancy. selection of required warnings to reach encourage smoking cessation and (Response) We agree that adults with a broad range of population groups, see discourage smoking initiation in these low education levels have higher than section III of this document regarding individuals. average smoking prevalence rates. For our selection of the final images. 2. Health Consequences of Smoking example, as discussed in the NPRM (75 (Comment 3) Multiple comments FR 69524 at 69526), 49.1 percent of stated that tobacco use disparities exist Smoking is responsible for at least adults with a General Education among lesbian, gay, bisexual, and 443,000 premature deaths per year in Development certificate (GED) and 28.5 transgender individuals. One comment the United States, and each year percent of adults with less than a high from a community organization stated cigarettes are responsible for school diploma were current smokers in that lesbian, gay, bisexual, and approximately 5.1 million years of 2009, compared with 5.6 percent of transgender individuals smoke at rates potential life lost (Ref. 1). Annual direct adults with a graduate degree (Ref. 4). almost 50 percent to 200 percent higher health care expenses due to smoking We also agree that graphic health than the rest of the population and total approximately $96 billion, and warnings may be particularly important strongly supported the proposed rule. annual productivity losses due to communication tools for these smokers, (Response) We agree that evidence premature deaths alone from cigarette as there is evidence suggesting that suggests that gay, lesbian, bisexual, and smoking total approximately $96.8 countries with graphic health warnings transgender populations have higher billion (Id.). demonstrate fewer disparities in health smoking rates than their heterosexual The Agency received many comments knowledge across educational levels counterparts (Ref. 13). The required that were supportive of the proposed (Ref. 11 at p. 18 and Ref. 3 at p. 295). warnings will help convey information rule, some of which reiterated the health (Comment 2) Multiple comments about various health risks of smoking to risks of smoking described in the NPRM noted that smoking rates vary by race individuals from a wide range of (75 FR 69524 at 69527 through 69529) and ethnicity, with American Indians/ demographic groups and will help and stressed the need for measures, Alaska Natives having the highest rates. encourage smoking cessation and such as graphic health warnings, to curb One comment also noted that the health discourage smoking initiation. smoking in the United States in order to and economic costs of smoking vary by (Comment 4) One comment from a improve health and to reduce the race and ethnicity. For example, the nonprofit research organization massive health care costs attributable to comment stated that African-American indicated that members of the U.S. tobacco-related illnesses. Some of these smokers suffer disproportionately from military have rates of smoking that are comments cited data demonstrating that smoking-related diseases, including unacceptably high, particularly among smoking is the leading cause or most lung cancer, heart disease, and strokes younger members. The comment powerful risk factor for particular (citing Ref. 12), and called for measures detailed the negative outcomes of diseases, such as chronic obstructive to address these disparities. smoking to military personnel, pulmonary disease (COPD), bladder One comment from a State public including lower physical performance, cancer, and atherosclerosis. health agency indicated that racial an increased risk of injury during However, FDA also received multiple minority populations and economically physical tasks, a greater number of days comments disputing the health risks of disadvantaged populations have sick and unable to report for duty, smoking. These comments and FDA’s smoking prevalence rates that are two to poorer job performance, and a higher responses are summarized in the three times higher than the general likelihood of premature discharge from following paragraphs. population. active duty, and stated that smoking and (Comment 5) One comment from an (Response) We agree that smoking its negative effects among active duty individual expressed a belief that rates vary by race and ethnicity and personnel costs the military an addiction to nicotine is 99 percent

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psychological and only 1 percent sudden infant death syndrome (SIDS) believe that these risks apply to them, pharmacological, and that nicotine is no (Id. at pp. 569, 576, 587 and 601). they illustrate the need for health more addictive than caffeine. Children who smoke experience warnings that effectively communicate (Response) We disagree with the impaired lung growth and an early onset the negative health consequences of assertion that nicotine addiction does of lung function decline (Id. at pp. 508– smoking to consumers. For additional not have a substantial physiologic 509, 2004 SG). Smoking during information regarding consumers’ lack component. While we acknowledge that adulthood also leads to a premature of knowledge of smoking risks, see behavioral processes play a role in onset of accelerated age-related decline section II.C of this document. initiation and maintenance of nicotine in lung function (Id. at p. 509). Smoking (Comment 8) One comment stated addiction, nicotine is a powerful also results in poor asthma control and that cigarettes are a minor public health pharmacologic agent that acts in a causes a range of respiratory symptoms concern compared to obesity and variety of ways at different sites in the in children, adolescents, and adults, alcohol, and that cigarette use results in body. As stated in the NPRM, nicotine including coughing, phlegm, wheezing, less health care costs than medical causes physical dependence and shortness of breath (Id.). treatment for the obese. characterized by withdrawal symptoms Furthermore, cigarette smokers have (Response) As discussed in the that usually accompany nicotine poorer overall health status compared to NPRM, cigarette smoking is the leading abstinence (75 FR 69524 at 69528). nonsmokers, and an increased risk of cause of preventable death and disease Regarding the relative addictiveness of adverse surgical outcomes related to in the United States (Ref. 4). nicotine and caffeine, caffeine is distinct wound healing and respiratory Furthermore, cigarettes are responsible from nicotine in its abuse liability, complications compared to nonsmokers. for health care expenditures and which includes a consideration of Smokers are also at an increased risk for productivity losses resulting in a multiple factors, including the hip fractures, and smoking increases the combined economic burden of dependence potential of a substance and risk for periodontitis, cataract, and the approximately $193 billion per year the degree to which it produces adverse occurrence of peptic ulcer disease in (Ref. 1). The total costs of smoking to effects (see Ref. 16 at p. 304). Caffeine persons who are Heliobacter pylori society are much higher, as the estimate produces only minimal disruptive positive (Id. at pp. 717–719, 736, 777, for productivity losses does not include 780, and 813). costs associated with smoking-related physiological effects and, unlike In addition, exposure to secondhand disability, employee absenteeism, or nicotine from tobacco products, caffeine smoke has been shown to cause a costs associated with secondhand- is generally not used in ways that are variety of negative health effects in smoke attributable disease morbidity considered to be of significant adverse nonsmokers, including lung cancer, and mortality (Id.). health effect (see Id. at pp. 285 and 304). cardiovascular disease, and respiratory We disagree that cigarettes are a (Comment 6) One comment stated symptoms (see Ref. 17). minor public health concern, even as that nicotine withdrawal is the only (Comment 7) Some comments were compared to other public health issues, medical condition that is irrefutably submitted by individuals disputing the and also disagree with the implication caused by cigarettes. negative health consequences of that the public health issue of smoking (Response) We disagree with this smoking that are described in the should not be addressed because other comment. While nicotine addiction is graphic warnings. These comments public health issues exist. The required one negative health effect of cigarette generally indicated that the individuals warnings will have a significant, smoking, it is not the only medical submitting the comments were smokers, positive impact on public health (75 FR condition irrefutably caused by and that they and/or their family 69524 at 69526), and as a result will cigarettes. As detailed in the 2004 report members (who were exposed to help mitigate the single largest cause of of the Surgeon General, ‘‘The Health secondhand smoke) had not preventable death and disease in the Consequences of Smoking,’’ which experienced negative health effects from United States. summarizes thousands of peer-reviewed smoking. scientific studies and was itself peer- (Response) We disagree with these B. Inadequacy of Existing Warnings reviewed, cigarettes have been shown to comments. Cigarette smoking has been In the preamble to the proposed rule, cause an ever-expanding number of shown to cause a wide range of negative FDA explained how cigarette packages diseases and conditions, including lung health consequences, as detailed in the and advertisements can be effective cancer, laryngeal cancer, oral cavity and previous response. Furthermore, it can channels for communication of pharyngeal cancers, esophageal cancer, be years before some of the negative important health information, bladder cancer, pancreatic cancer, health consequences of smoking particularly given that pack-a-day kidney cancer, stomach cancer, cervical clinically manifest. Thus, the personal smokers are potentially exposed to cancer, acute myeloid leukemia, all the health status of the individuals warnings more than 7,000 times per major clinical cardiovascular diseases, submitting these comments could year (75 FR 69524 at 69529). However, COPD, and a range of acute respiratory change in the future. A scientific the existing warnings have suffered illnesses (Ref. 2). determination that a product causes a from three crucial problems: (1) They Maternal smoking during pregnancy particular negative health consequence have not changed in more than 25 years, causes a reduction in lung function in is based on data from large groups of (2) they often go unnoticed, and (3) they infants, and women who smoke during individuals, and the fact that an fail to convey relevant information in an pregnancy are more likely to experience individual product user has not effective manner. FDA also explained premature rupture of the membranes, experienced (or has not yet experienced) that larger, graphic warnings placenta previa, and placental abruption a particular negative health communicate the health risks of (Id. at pp. 508 and 576). Smoking also consequence does not mean the product smoking more effectively. The preamble increases rates of preterm delivery and does not cause that harm. to the proposed rule presented extensive shortened gestation, and women who Moreover, to the extent these evidence from other countries’ smoke are twice as likely as nonsmokers comments indicate that many smokers experiences with graphic warnings as to have low birth weight infants; do not fully understand the serious well as information from the 2007 IOM smoking also increases the risk of health risks of cigarettes or do not Report (75 FR 69524 at 69531). On the

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basis of the available scientific extent of the health risks associated current smokers did not agree that evidence, the IOM concluded that with smoking cigarettes (75 FR 69524 at smoking increases a person’s chances of larger, graphic warnings would promote 69530 through 69531). getting cancer ‘‘a lot’’ (Ref. 24). greater public knowledge of the health FDA received many comments Furthermore, one study, involving risks of using tobacco and would help regarding the level of consumers’ smokers’ perception of their personal reduce consumption (Ref. 3). knowledge regarding the health risks of risk, found that only 40 percent of We received numerous comments smoking. Several comments stated that current smokers believed they had a regarding the adequacy of the existing consumers are adequately informed higher-than-average risk of cancer and warnings that appear on cigarette about the risks of smoking or even only 29 percent believed they had a packages and advertisements. The large overestimate the risks of smoking, while higher-than-average risk of heart disease majority of these comments supported many other comments explained that (Ref. 25). Even among heavy smokers our analysis of the existing warnings, consumers lack knowledge about a wide (those who smoke at least 40 cigarettes but a few comments disagreed with this variety of smoking risks. A summary of per day), less than half believed they analysis. These comments, and our these comments, and our responses, is were at increased risk for these diseases responses, are summarized in the included in the following paragraphs. (Id.). In another demonstration of following paragraphs. (Comment 10) Several comments, underestimation of personal risk, a (Comment 9) A substantial number of including comments from tobacco study found that adolescent smokers comments, including those from health product manufacturers and individual underestimated their personal risk, even institutions, nonprofit organizations, consumers, objected to the new required if they had an accurate sense of the academics, and consumers, agreed with warnings, in part because they claimed statistical risk (Ref. 22). FDA’s conclusion that the existing that consumers already know the health A 2005 study of smokers in the warnings that appear on cigarette risks associated with smoking. The United States and three other countries packages and advertisements are submitters expressed the belief that the found that there were significant gaps in ineffective at conveying the health risks new warnings are unnecessary, because smokers’ knowledge about the risks of of smoking (75 FR 69524 at 69529 the new warnings provide information smoking and that smokers living in through 69531). that the public has been aware of for countries where health warnings However, one comment stated that the many years. referred to specific disease current warnings were ‘‘fine.’’ Two (Response) We disagree. Many consequences of smoking were much comments expressed the belief that the comments provided significant evidence more likely to be aware of those existing warnings have worked to support the notion that consumers, consequences (Ref. 26). The study successfully in the current information including those in communities with concluded that smokers are not fully environment. low literacy rates and military informed about the risks of smoking, (Response) We disagree with the personnel, actually lack knowledge or and that warnings that are graphic, comments stating that the existing underestimate the risks associated with larger, and more comprehensive in warnings that appear on cigarette smoking. As discussed in this content are more effective in packages and advertisements are document, this lack of knowledge may communicating the health risks of effective. As several other comments involve either an incomplete smoking (Id.). noted, the Surgeon General has long understanding of the statistical risks or Thus, even if consumers are aware of recognized that the cigarette warnings a failure to understand the personal (as certain negative health consequences of are deficient. For example, in its 1994 opposed to the statistical) risks (see also smoking, such as lung cancer and report the Surgeon General noted that section XI.B.2 of this document). There emphysema, and even if they are aware the warnings had become ineffective is also a possibility that the risks are not of certain statistical risks, many smokers due to their size, shape, and familiarity considered at the time of purchase, even underestimate their personal risks, and (Ref. 18). That same year, the IOM if they are understood—a special many Americans are under-informed concluded that the warnings were problem for those who are deciding about other health risks associated with ‘‘inadequate * * * and woefully whether to start to smoke. The smoking. For example, while nearly all deficient when evaluated in terms of requirements adopted here should help daily smokers in one study correctly proper public health criteria’’ (Ref. 19 at to counteract all of these problems. identified that smoking caused lung p. 237). Yet those same warnings are While most smokers understand that cancer (99 percent) and emphysema (97 still in use more than 16 years after the smoking poses certain statistical risks to percent), a lower percentage of Surgeon General’s report and 26 years their health, many fail to appreciate the respondents correctly identified after their inception. Accordingly, we severity and magnitude of those risks smoking as causing low birth weight conclude that the existing warnings for (Refs. 20 and 21), and there is evidence babies (88 percent), worsened asthma cigarettes do not adequately that even when smokers appreciate the (85 percent), miscarriages (76 percent), communicate the health risks of statistical risk, they underestimate the other cancers (69 percent), head and smoking. personal risk that they face (Ref. 22). A neck cancers (68 percent), cervical 2007 survey found that two in three cancer (48 percent), stomach ulcers (46 C. Consumers’ Lack of Knowledge of the smokers underestimate the chance of a percent), reproductive difficulties (44 Health Risks smoker developing lung cancer percent), osteoporosis (41 percent), and In the preamble to the proposed rule, compared to a nonsmoker (Ref. 23). The SIDS (40 percent) (Ref. 27). In fact, FDA described how the existing survey also found that up to a third of research indicates that most people warnings that currently appear on smokers erroneously believe that certain know only one or two of the many cigarette packages and advertisements activities, such as exercise and taking diseases causes by smoking. One survey have largely gone unnoticed by both vitamins, could ‘‘undo’’ most of the found that while a majority of people smokers and nonsmokers (75 FR 69524 effects of smoking (Id.). knew that smoking caused life- at 69530). FDA also provided clear Other research also highlights how threatening illnesses, more than half of evidence that the warnings have failed smokers underestimate the health the respondents were unable to name a to convey appropriately crucial effects of smoking. For example, in a smoking-related illness other than lung information such as the nature and 2008 survey, more than one-quarter of cancer (Ref. 28). Similarly, researchers

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found that when asked about health impact on children’s asthma (Ref. 38), that large graphic health warnings, such risks of smoking, 39 percent of and a 2009 study found that nearly one- as those being required in this rule, are respondents either answered incorrectly fifth of Americans do not believe that more likely than text-only warnings to or said they did not know (Ref. 29). secondhand smoke is dangerous to (1) get consumers’ attention, (2) Americans also lack adequate nonsmokers (Ref. 39). influence consumers’ awareness of understanding of the addictive nature of There is a final point. Even if many cigarette-related health risks, and (3) cigarettes. Although one comment people do have an accurate affect smoking intentions and behaviors. provided local surveys showing that understanding of the statistical risk, and FDA received many comments on the adults already know that cigarettes are even if, in the abstract, many smokers efficacy of large, graphic warnings, as addictive, there is also evidence that also have an accurate understanding of well as comments regarding the many adolescents do not appreciate the their personal risk, that understanding potential for any rebound effect from the addictive nature of cigarettes. The 2007 may be too abstract to be thought of at use of graphic warnings. Those IOM Report explained that ‘‘adolescents the time of purchase, especially (but not comments, and FDA’s responses, are misperceive the magnitude of smoking only) for those who are starting to summarized in the following harms and the addictive properties of smoke. Efforts to make the relevant risks paragraphs. tobacco and fail to appreciate the long- salient are justified and indeed required (Comment 12) A wide variety of term dangers of smoking, especially under the Tobacco Control Act. comments, including those from health when they apply the dangers to their (Comment 11) A few comments institutions, nonprofit organizations, own behavior’’ (Ref. 3 at p. 93). In claimed that adults actually and academics, agreed with FDA’s addition, one survey found that fewer overestimate the risks of smoking- findings in the NPRM that larger, than 5 percent of daily smokers in high related disease, and stated that this graphic warnings are effective. school think that they still will be further underscores the lack of a need However, several comments stated smoking at all in 5 years, yet more than for graphic health warnings. In that the changes in the format and 60 percent of high school smokers are particular, one comment referred to a placement of the warnings being regular daily smokers 7 to 9 years later Montana survey in which adults proposed, including the use of graphic (Ref. 30). Another survey found that believed that smoking caused colon images, will not result in reductions in only 7.4 percent of adult smokers and cancer. cigarette use given the experiences in 4.8 percent of young smokers expected (Response) We disagree with these other countries. For example, one to smoke longer than 5 years when they comments. While the Montana survey comment noted that Health Canada’s started, but 87 percent of these adults referred to in one of the comments own data found, among other things, and 76 percent of these youth reported indicates that some consumers are not that there was no statistically significant that they had been smoking for more aware of the precise relationship decline in smoking incidence than 5 years (Ref. 31). between smoking and certain diseases consumption for adolescents or adults There is also evidence that certain (for example, the 2004 Surgeon after the introduction of graphic demographic groups are even less aware General’s report notes that the evidence warnings. This comment expressed the of the negative health consequences of is suggestive but not sufficient to infer belief that Canada’s warnings have been smoking, which is particularly a causal relationship between smoking ineffective and that FDA’s graphic concerning in light of the evidence that and colorectal cancer (Ref. 2 at p. 26)), health warnings will be similarly these groups also have some of the we are aware of significant research ineffective. highest smoking prevalence rates (see indicating that many consumers are not (Response) For the reasons stated in section II.A.1 of this document). For sufficiently aware of the risks associated the NPRM, we conclude that larger, example, research shows that with smoking, as discussed in the graphic warnings are effective in knowledge of smoking risks is lower previous response. We find that the conveying the health risks of smoking, among people with lower incomes and weight of evidence clearly demonstrates influencing consumer awareness of fewer years of education (Refs. 32 33 that many consumers lack adequate these risks, and affecting smoking and 24). Smokers in the military also knowledge about the health risks of intentions. We disagree with comments underestimate the actual risk of serious smoking—especially the personal risks. stating that the change in format and disease and substantially underestimate In addition, the comments claiming that placement of the warnings will not be their own risks (a point that fits well adults overestimate smoking’s risks fail effective. The set of required warnings with the evidence of underestimation of to take into account consumers’ lack of we have selected will satisfy our personal risks) (Refs. 34 35 and 36). knowledge of other health risks due to primary goal, which is to effectively In addition to underestimating the smoking, like the dangers of convey the negative health risks smoking poses to their own health, secondhand smoke, reproductive consequences of smoking on cigarette Americans underestimate the health difficulties, and miscarriages, as packages and in advertisements, and effects of secondhand smoke on others. described in the previous response. this effective communication can help In the 2010 Report, ‘‘How Tobacco both to discourage nonsmokers, Smoke Causes Disease: The Biology and D. Larger, Graphic Warnings including minor children, from Behavioral Basis for Smoking- Communicate More Effectively initiating cigarette use and to encourage Attributable Disease,’’ the Surgeon Since Canada first introduced graphic current smokers to consider cessation to General concluded that ‘‘many of the health warnings for cigarettes in 2001, greatly reduce the serious risks that effects from active smoking can be an extensive evidence base has been smoking poses to their health. observed in persons involuntarily developed to examine the effects of The research literature clearly exposed to cigarette smoke’’ (Ref. 37). In graphic health warnings in Canada and indicates that larger, graphic warnings addition, individual studies have shown in the more than 30 other countries that are effective at communicating the that secondhand smoke triggers have adopted similar requirements for health risks associated with smoking, childhood asthma and is associated graphic health warnings on cigarettes. encouraging users to quit smoking, and with both heart disease and cancer (Ref. As FDA extensively discussed in the discouraging nonsmokers from 17). Yet, most parents believe that NPRM (75 FR 69524 at 69531 through beginning to smoke. We already smoke exposure has little or no negative 69533), the research literature indicates included significant research to

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substantiate this conclusion in the initiating cigarette use and to encourage working (Ref. 42 at p. 43). They also preamble to the proposed rule, and the current smokers to consider cessation to noted that some of the warning comments did not specifically dispute greatly reduce the serious risks that messages the comments referred to, this analysis (see 75 FR 69524 at 69531 smoking poses to their health’’ (75 FR including the referenced dental disease through 69532). In addition, as we noted 69524 at 69526). Therefore, the image, provoked a highly emotional in the NPRM, the available evidence warnings are intended to have an response in all the countries surveyed demonstrates that graphic health impact on nonsmokers as well as despite the comments from certain focus warnings are (1) more likely to be smokers, and the required warnings will group participants (Id. at p. 35). The noticed than text-only warnings, (2) effectively communicate the negative research literature suggests that images more effective for educating smokers health consequences of smoking to both that evoke emotional responses can about the health risks of smoking and of these important audiences. increase the likelihood smokers will for increasing the time smokers spend (Comment 14) Several comments, reduce their smoking, make an attempt thinking about the health risks, and (3) including comments from cigarette to quit, or quit altogether (Ref. 44). associated with increased motivation to manufacturers and individual While one comment said that the quit smoking (Id.). As several comments consumers, expressed concerns that the failure of fear-inducing messages based noted, evidence from countries with new required warnings on cigarette on health effects is ‘‘well-known in graphic health warnings also indicates packages and advertisements would areas outside of smoking prevention,’’ that such warnings are an important cause people not to look at packages or the comment did not provide sufficient information source for younger smokers, cause them to hold their cigarettes in evidence of such failure in the area of and that pictures are effective in decorative cases. The comments also smoking prevention. In fact, as some conveying messages to children (Ref. 40 indicated that some of the proposed comments discussed, there is scientific at pp. 3, 20, and 24–26). These images would induce youth to purchase evidence relating to cigarette graphic important effects of graphic warnings cigarettes rather than deter them from health warnings illustrating the success are sustained longer than any impact smoking, because the new images would of fear-inducing messages (see, e.g., Ref. from text-only warnings (Ref. 41). be striking to youth. These comments 44). For example, one comment referred Further, the data from Health Canada stated that this ‘‘rebound effect’’ would to research that found that smokers does not indicate that the warnings have undermine the intent of the warnings exposed to Canada’s graphic health been ineffective at conveying the health and decrease their effectiveness. warnings generally did not try to avoid risks of smoking and impacting smoking (Response) We disagree. Comments the fear-inducing messages, and that any intentions. We cited several studies in expressing concerns about a potential avoidance engaged in by smokers does the preamble (including data from rebound effect did not provide not appear to undermine quitting Health Canada) that illustrated the persuasive scientific evidence to intentions or attempts (citing Ref. 45). effectiveness of the Canadian graphic demonstrate such an effect is likely to Similarly, researchers analyzing data health warnings, which have been occur (or that it would have sufficient related to graphic warnings found that: found effective at providing youth and magnitude to be a significant concern). [T]here is no evidence that pictorial adult smokers with health information, The comments referenced older studies warnings lead to boomerang effects. An making consumers think about the that did not specifically address graphic analysis of data from the ITC Four Country health effects of smoking, and warnings on cigarette packages and Survey found that the Australian pictorial increasing smokers’ motivations to quit advertisements, and also referred to a warnings, introduced in 2005, led to greater smoking, among other things (see 75 FR qualitative study conducted on the avoidant behaviours (e.g. covering up the 69524 at 69532). For example, national European Union’s graphic warnings, in pack, keeping it out of sight, or avoiding which some focus group participants particular labels), compared to Canada, the surveys conducted on behalf of Health United Kingdom, and the USA. Importantly, Canada indicate that approximately 95 commented that some warnings were those smokers who engaged in avoidant percent of youth smokers and 75 humorous or that they were not behaviours were no less likely to intend to percent of adult smokers report that the persuasive in educating consumers quit or to attempt to quit replicating the Canadian pictorial warnings have been about dental diseases associated with findings of a study of the Canadian warnings. effective in providing them with smoking (Ref. 42). When weighing this Thus, although pictorial warnings can lead to important health information (Ref. 3 at qualitative information against the avoidance and defensive reactions, such p. 294). quantitative research available, reactions are actually indicators of positive (Comment 13) One comment including evidence from countries with impact. suggested that the new required graphic health warning requirements, as (Ref. 46, citing Refs. 20 and 44). To the warnings will have a greater impact on well as the findings of the expert panel extent that smokers engage in any nonsmokers who inadvertently view of the IOM in its 2007 report (see Ref. defensive avoidance with respect to the cigarette packages than on smokers and, 3), the information referenced in the new required warnings, we are adding therefore, will not be effective in comments is not persuasive. (While a reference to a cessation resource to achieving FDA’s goals. focus groups can provide useful give smokers an immediate way to act (Response) We are not aware of any information, it is well known that they upon this impulse and access cessation evidence to substantiate this comment. are not as reliable as real-world assistance. The research literature Further, our required warnings are evidence for drawing conclusions about suggests that such a reference is intended to have an impact on both causal relationships and generalizing effective in diminishing potential smokers and nonsmokers. As stated in results to the population as a whole avoidance effects in response to the preamble to the proposed rule, ‘‘the (Ref. 43).) messages that arouse fear (see Ref. 40 at new required warnings are designed to Furthermore, we note that in the pp. 39–41). See section V.B.6 of this clearly and effectively convey the European Union qualitative study document for additional information negative health consequences of referenced in the comments, the regarding our rationale and authority for smoking on cigarette packages and in researchers concluded that pictures including a reference to a cessation cigarette advertisements, which would have the potential to add a powerful resource in the required warnings. help both to discourage nonsmokers, element to health warning messages and (Comment 15) Several comments including minor children, from that the old text-only messages were not expressed concern about the potential

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effectiveness of the new required emotional response from viewers can Nevertheless, as stated in the NPRM, warnings, particularly those that are confer negative feelings about smoking we intend to monitor the effects of the fear-based, with certain portions of the and undermine the appeal and new required warnings once they are population. These comments expressed attractiveness of smoking (Ref. 45 and put into use. We will conduct research the following concerns: (1) Many youths Ref. 40 at pp. 37–38). In addition, and keep abreast of scientific and young adults are rebellious and will research has shown that younger developments regarding the efficacy of be attracted to what they perceive as the adolescents are more likely to notice various required warnings and the types ‘‘forbidden fruit;’’ (2) fear-based and think about health warnings that and elements of various warnings that warnings fail with groups that have low include graphic images (Ref. 47). improve efficacy. As stated in the self-esteem; (3) fear-based warnings fail The required warnings will effectively NPRM, we will use the results of our with adolescents, because they tend not communicate the negative health monitoring and such research to help to be influenced by health-based consequences of smoking, and we do determine whether any of the textual deterrents; and (4) the new required not agree that they will have unintended warning statements or accompanying warnings are ‘‘high fear messages’’ that negative effects among younger graphic images should be revised in a may actually inhibit reductions in population groups. future rulemaking (75 FR 69524 at smoking, because they decrease a (Comment 16) One comment 69534). This commitment to continued person’s perceived ability to quit expressed concern that the new graphic empirical testing is consistent with smoking. These comments expressed images on cigarette packages and Executive Order 13563, section 1, which the belief that the new required advertisements would actually make states that our regulatory system ‘‘must warnings would be ineffective. cigarette smokers sicker, as the images measure, and seek to improve, the (Response) While acknowledging the would increase smokers’ anxiety and actual results of regulatory concerns, we disagree. It is true that damage their self-esteem. requirements.’’ messages that induce fear, pointing to a (Response) We disagree. We are not FDA received numerous comments risk, may not be effective when people aware of any scientific evidence to regarding the need periodically to are unaware of how to reduce the risk, support this claim. In fact, as discussed refresh the warnings to minimize wear but in this case, the best way to reduce in the preamble to the proposed rule, out, which we have summarized and the risk is clear. We have chosen a the available evidence suggests that responded to in the following balanced set of images, including those graphic health warnings can benefit the paragraphs. that may arouse fear and those that may public health by increasing smokers’ (Comment 18) Many comments, generate other emotional responses in intentions to quit and reducing the including comments from health certain individuals in order to reach a likelihood of initiation by nonsmokers institutions, nonprofit organizations, diverse population of smokers and (75 FR 69524 at 69532). and academics, suggested that FDA nonsmokers, as well as youth, young (Comment 17) A few comments stated should refresh the graphic warnings on adults, and adults. Furthermore, as is that fear-based warnings fail to work a regular basis because consumers can explained in more detail in section III.B when the message being conveyed is become habituated to and ignore of this document, we conducted a already clearly understood and does not warnings. The comments referred to research study to quantitatively evaluate provide new information. These scientific research on the effectiveness the relative efficacy of the proposed comments expressed the view that, of graphic warnings for cigarette required warnings in communicating because consumers already understand packages and advertisements, which the health harms of smoking to adults the risks associated with smoking, the strongly recommends that warnings be (aged 25 or older), young adults (aged 18 new required warnings would not be periodically refreshed to maintain their to 24), and youth (aged 13 to 17). The effective in achieving FDA’s goals. effectiveness and impact on consumers nine selected required warnings showed (Response) We disagree. As explained (Refs. 18, 42, 44, and 26). The comments positive effects on important study in section II.C of this document, there is suggested a wide range of timeframes as measures in all study populations, substantial evidence demonstrating that to when FDA should refresh the graphic including youth, relative to the text-only the premise of these comments is not warnings. One comment suggested that control. In particular, as is discussed in correct and that many consumers do not FDA track the effectiveness of the more detail in section III of this adequately understand the personal required warnings on a quarterly basis document, the selected required risks associated with smoking. and that the results of any testing be made publicly available. One comment warnings showed strong impacts on the E. Need To Refresh Required Warnings salience measures in our research study, suggested that FDA establish a including emotional and cognitive As amended by the Tobacco Control conclusion that new graphic warnings measures. Act, FCLAA includes provisions that for cigarette packages and The research literature suggests that can help prevent or delay the wear out advertisements will be required at no these measures are likely to be related of the new required warnings. For more than a 2-year interval. A few to behavior change. For example, the example, section 4(c)(1) of FCLAA (15 comments also suggested that FDA literature suggests that risk information U.S.C. 1333(c)(1)) indicates that the establish a target schedule for is most readily communicated by required warnings on cigarette packages reconsideration and revision of the messages that arouse emotional must be randomly displayed in each 12- warnings, which would include ongoing reactions (see Ref. 45), and that smokers month period, in as equal a number of consumer research and re-examination who report greater negative emotional times as is possible on each brand of the of the effectiveness of the required reactions in response to cigarette product, and be randomly distributed warnings. warnings are significantly more likely to throughout the United States, in (Response) We agree that refreshing have read and thought about the accordance with a warning plan the required warnings on a periodic warnings and more likely to reduce the approved by FDA. Section 4(c)(2) of basis can help maintain their amount they smoke and to quit or make FCLAA requires the warnings to be effectiveness. Researchers have found an attempt to quit (Ref. 44). The rotated quarterly in cigarette that graphic images and text messages research literature also suggests that advertisements, also in accordance with are likely to have greater impact at the warnings that generate an immediate a warning plan approved by FDA. time they are introduced and that

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meaningful impact of the warnings may color graphic images FDA developed detailed description of the research decline with repeated exposure (Ref. and the nine textual warning statements study). 41). Rotating a variety of cigarette from the Tobacco Control Act. These 36 In addition, we considered the warnings and updating the warnings proposed required warnings were made substantive public comments received periodically is likely to minimize the available as electronic files in portable in the docket related to the 36 proposed negative effects of overexposure (Ref. 3). document format (.pdf) and displayed in required warnings (see section III.C of However, we are not aware of any the document entitled ‘‘Proposed this document for more information on research that warrants the selection of a Required Warning Images,’’ which was the comments received; the comments particular timeframe for future iterations included in the docket for the proposed relating to each image are summarized of required warnings. As stated by rule. The proposed required warnings and responded to in sections III.D and several comments, there is no definitive were also made available on FDA’s Web III.E of this document). We also rate at which the warnings will wear site. Consistent with section 4 of considered the comments received in out, as it depends on many factors FCLAA, 2 versions of each of the 36 the docket that suggested that we use including the variety of message proposed required warnings were other images in the required warnings, executions, exposure level, and the developed; one with the textual warning including images that have been used in appeal of the message. statement in black font on a white other countries’ graphic health We recognize the value of conducting background, and one with the textual warnings. However, as discussed in ongoing evaluation of the effects of the warning statement in white font on a more detail in the following comment required warnings after they enter the black background. summaries and in section III.B of this marketplace. We also intend to monitor As explained in the preamble to the document, we selected images for the and evaluate the effects of the required proposed rule (75 FR 69524 at 69534 nine required warnings from among the warnings, and to monitor the warnings through 69535), in considering and images we developed and proposed. for potential wear out. In addition, we developing appropriate color graphic Our research study, among other will keep abreast of scientific images to accompany the nine textual information, indicated these required developments regarding the efficacy of warning statements set forth in section warnings will effectively communicate various required warnings and the types 201 of the Tobacco Control Act, FDA the negative health consequences of and elements of various warnings that assessed the graphic warnings that other smoking to a wide range of population improve efficacy. As noted, this countries have required, and worked groups. As explained in the comment monitoring is consistent with Executive with various experts in the fields of responses throughout this section III, Order 13563, which recognizes the health communications, marketing the comments submitted to the docket importance of measuring ‘‘actual research, graphic design, and did not persuade us that other images, results’’ and of analyzing significant advertising to develop 36 proposed including images used in other rules after they are in effect to determine required warnings. Each of the proposed countries’ graphic health warnings, whether they should be ‘‘modified, color graphic images depicted the were more appropriate for use in the streamlined, expanded, or repealed so negative health consequences of required warnings than the images we as to make the agency’s regulatory smoking, and the themes and subjects selected. program more effective or less depicted in each image illustrated the Furthermore, we considered the burdensome in achieving the regulatory message conveyed by the accompanying relevant scientific literature in the objectives.’’ textual warning statement. docket, and in particular the extent to When we determine that changes to The NPRM explained that we planned which the literature supported or the required warnings are appropriate to select 9 final required warnings from refuted aspects of the images and the (including changes to the textual among the 36 proposed required extent to which the literature helped warning statements and/or the color warnings. We sought comments on what determine the appropriate weight to graphic images) because they would color graphic images to require in this give to other information (including the final rule, including comments on the appropriate weight to give to the various promote greater public understanding of 36 proposed color graphic images endpoints considered in our research the risks associated with smoking, we included with the NPRM. study). can exercise our authority to initiate a In addition, as is described in more We also considered the variety and new rulemaking to modify the required detail in section III.B of this document, diversity reflected in the images in warnings under section 202(b) of the we conducted research on the 36 making selection decisions in order to Tobacco Control Act (adding subsection 1 proposed required warnings to evaluate ensure that the final set of required (d) to section 4 of FCLAA). the relative effectiveness of the warnings effectively communicates risk III. FDA’s Selection of Color Graphic proposed color graphic images and their information to a diverse range of Images accompanying textual warning audiences, including audiences that statements at conveying information have been targeted by tobacco industry A. Methodology for Selecting Images about various health risks of smoking, marketing efforts. We took into account When we issued the NPRM, we and additionally, at encouraging the importance of selecting a set of proposed color graphic images to smoking cessation and discouraging required warnings that includes a accompany the nine textual warning smoking initiation. diversity of styles (e.g., photographic statements required by Congress in In order to determine which color versus illustrative), themes, and human section 201 of the Tobacco Control Act. graphic images to require in the final images (e.g., race, gender, age). This is In all, we proposed 36 potential rule, we considered a number of factors. consistent with the evidence base for required warnings, consisting of the First, we considered the relative graphic health warnings from countries effectiveness of the proposed required that have already implemented such 1 Section 202(b) of the Tobacco Control Act warnings based on the strength of effect warnings, which indicates that variety is amends section 4 of FCLAA (15 U.S.C. 1333) to add the different color graphic images had important in enhancing the noticeability a new subsection (d), ‘‘Change in Required Statements.’’ However, section 201 of the Tobacco on the various endpoints and across the and salience of warnings and Control Act also amends section 4 of FCLAA to add populations included in our study (see broadening their relevance for target a new subsection (d), ‘‘Graphic Label Statements.’’ section III.B of this document for a more groups (Ref. 40 at p. 46 and Ref. 48 at

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p. 9), and which suggests that warnings various required warnings and the types recommended the use of an image that include pictures of people should and elements of various warnings that depicting the amount of money smokers broadly represent the ethnic/racial improve efficacy. Given the significant spend to purchase cigarettes every year. profile of the relevant country (Ref. 11). changes being made to the text, format, (Response) We decline to select the We also considered whether to have and placement of the existing warnings images suggested in these comments. one image accompany each of the by this rule, it will be valuable to obtain Each of the required warnings selected textual warning statements set forth in relevant data on the effects of the by FDA was quantitatively tested to section 201 of the Tobacco Control Act. complete set of required warnings as assess its relative effectiveness in We received multiple comments soon as possible. If we were to expand communicating the negative health regarding our proposal to select 9 final the number of required warnings, it consequences of smoking. In selecting required warnings and our proposal to could delay an assessment of efficacy of the set of nine required warnings, we select them from among the 36 proposed the warnings under conditions of real- considered the results of our research color graphic images that were made world use. We intend to use the results study and a number of other factors and available with the NPRM. We have of our monitoring and of research have concluded that the nine selected summarized and responded to these conducted on the required warnings required warnings effectively comments in the following paragraphs once they are in public use to determine communicate the negative health (we also received a number of whether changes should be made to the consequences of smoking. In addition, comments on the proposed color required warnings in a future we are adopting the nine textual graphic images themselves; these rulemaking, including changes to add warning statements mandated by comments are summarized in sections new images or to modify the existing Congress in section 4(a)(1) of FCLAA. III.D and III.E of this document. In required warnings. Accordingly, at this The images selected were designed to addition, we received a number of time we decline to select more than nine correlate with those warning statements; comments regarding our research study, images. the available evidence base highlights which assessed the relative effectiveness (Comment 20) Multiple comments the value of the text and images in of the 36 proposed color graphic images; suggested that FDA use graphic warning graphic health warnings relating to one these comments are summarized in images that have been tested or used in another in a meaningful way (see Ref. 40 section III.C of this document). other countries instead of or in addition at p. 41). Including images inconsistent (Comment 19) Several comments to one or more of the images that FDA with the textual warning statements suggested that FDA select more than one proposed. Some of these comments could confuse consumers and detract graphic image for each new textual indicated that images that are in use in from the effectiveness of the warnings. warning statement. The comments other countries would be more effective Furthermore, some of our selected reasoned that by limiting the warnings and educational than some or all of images do show the negative cosmetic to one graphic image per textual FDA’s proposed images. effects that can occur as a result of the statement, the health warnings would (Response) We decline to follow this health consequences of smoking. effectively communicate to fewer suggestion. FDA’s research study Moreover, some of the images proposed segments of the smoking and evaluated the 36 proposed required for use in the comments, such as an nonsmoking populations. Some warnings. The results from this research image showing the amount of money comments also suggested that selecting study suggest that the nine selected smokers spend to purchase cigarettes, more than one image per warning required warnings will effectively would not be consistent with the statement would counteract wear out of communicate negative health statutory requirement that the required the required warnings. One comment consequences of smoking to a diverse warnings depict the negative health suggested that FDA develop multiple range of audiences. Moreover, if we consequences of smoking. series of images and require that each were to select images that were not series be used one at a time to delay evaluated in our study, it would be B. FDA’s Research Study wear out. difficult to objectively assess the relative As explained in the NPRM (75 FR (Response) We decline to select more efficacy of such images compared to the 69524 at 69535), we conducted research than one image for each warning 36 proposed images. Compared to the on the 36 proposed required warnings. statement as suggested in these information provided by our research Specifically, we conducted an Internet- comments. We believe that the set of study, the supporting information in the based consumer research study with nine required warnings we selected will comments did not convince us that the over 18,000 participants that be sufficient at this time to achieve our images suggested by those comments quantitatively examined the relative goal of effectively communicating the would more effectively communicate efficacy of the 36 proposed color negative health consequences of the negative health consequences of graphic images in communicating the smoking and to prevent wear out of the smoking than the images we have harms of smoking to 3 target groups: required warnings for several years. selected in this final rule. Adult smokers (age 25 or older), young Furthermore, the nine selected required (Comment 21) A number of comments adult smokers (aged 18 to 24), and youth warnings will appeal to a diverse range suggested that FDA use other images (aged 13 to 17) who currently smoke or of audiences, and, as discussed in than those published with the proposed who are susceptible to smoking. section III.D of this document, the rule. For example, some comments The purpose of the study was to: (1) images selected showed significant recommended that FDA use images that Measure consumer attitudes, beliefs, effects on important measures in our depict real people with real diseases and intended behaviors related to research study across the three study and not models. A few recommended cigarette smoking in response to the populations (adults, young adults, and that FDA include images that show proposed color graphic images and their youth). negative cosmetic effects of smoking, accompanying textual statements; (2) We intend to monitor the effects of such as stained fingers and bad breath, determine whether consumer responses these required warnings once they are in order to impact adolescents to the proposed color graphic images put into use. We will conduct research concerned about body image. One and their accompanying textual and keep abreast of scientific comment suggested that FDA portray a statements differed across various developments regarding the efficacy of picture of an obituary, while another groups based on age, smoking status, or

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other demographic variables; and (3) of cigarettes that included one of the Regression analyses were used to assess evaluate the relative effectiveness of the proposed required warnings, which the relative impact of treatment proposed color graphic images and their appeared on the upper 50 percent of the conditions on ratings as compared to the accompanying textual warnings pack, while the control group viewed a text-only control. statements at conveying information hypothetical pack of cigarettes with a • Recall—The study measured about various health risks of smoking, warning statement (but no warning participants’ recall of the nine warning and additionally, at encouraging image), which appeared on the side of statements after exposure to either one smoking cessation and discouraging the pack. Furthermore, among adults, an of the proposed required warnings or smoking initiation. additional treatment group viewed a the text-only control (baseline). We placed a report (Ref. 49; see also hypothetical advertisement that Participants were also re-contacted after Ref. 50 2) that described the research included one of the proposed required 1 week and asked about their recall of study and presented the results of the warnings, which encompassed the warning statement they had viewed analyses from the research study in the approximately 20 percent of the upper (1 week follow-up). The results were docket for the proposed rule and right area of the advertisement, while a analyzed to determine whether announced the report’s availability by a control group viewed a hypothetical exposure to the proposed required notice in the Federal Register on advertisement with a warning statement warnings elicited higher recall of the December 7, 2010 (see 75 FR 75936 at in the same location (but without a warning statements than exposure to the 75936 through 75937) so that the public warning image) that was presented text-only controls. In addition, in the had an opportunity to comment on the using the size and format currently treatment groups (i.e., participants who results. required by FCLAA. The study tested viewed one of the proposed required This section briefly describes the the relative efficacy of each proposed warnings), recall of the image was design of FDA’s research study and key required warning relative to the text- assessed at baseline and at 1-week endpoints examined in the research only control for that warning statement follow-up. Because the control group study; a full description of the study for the various outcomes measured. did not view an image, the impact of the and the several hundred pages of data Each respondent viewed either a proposed required warnings on image and data analyses are contained in the single cigarette package or recall was measured against one of the study report and accompanying advertisement that displayed one of the proposed required warnings for each appendices (Ref. 49) that was placed in proposed required warnings or a text- warning statement that had been the docket for the proposed rule. This only warning. Respondents answered selected to be the referent image and section also describes how the results questions about their immediate statistically assessing whether recall of reactions to the cigarette package or from this research study informed the the images associated with the other advertisement, related attitudes and selection of the final required warnings. proposed required warnings was higher beliefs about smoking, as well as FDA received numerous comments in or lower than recall of the referent intentions to quit or start smoking. At the docket related to the research study; image. this section also includes a summary of the end of the survey, subjects were • Influence on Beliefs—The study the substantive comments received asked to recall which warning statement assessed whether the proposed required about the research study and FDA’s and image they saw earlier in the survey warnings had a significant impact on responses to these comments. to assess the accuracy of recall. In addition, 1 week after completing the beliefs about the health risks of smoking 1. Study Design survey, subjects were re-contacted and to regular smokers relative to the text- FDA’s research study evaluated the asked to recall the warning statement only control, as well as whether they required warnings proposed for each of and image to which they were exposed. had a significant impact on beliefs about the nine warning statements against a Overall, the following key outcomes the health risks of secondhand smoke text-only control (which contained the were measured after exposure to one of exposure to nonsmokers relative to the warning statement without any the required warnings or the text-only text-only control. • accompanying color graphic image). control, and/or at 1 week follow-up: Behavioral Intentions—The study Study participants were randomly • Salience—The study examined assessed whether the proposed required assigned to be exposed to either one of emotional and cognitive responses to warnings may have a significant impact the 36 proposed required warnings the cigarette packages and on cessation, by assessing smokers’ (treatment groups) or one of the 9 advertisements that bore health intentions to quit smoking (i.e., asking textual warning statements (control warnings. Participants provided ratings participants how likely it is that they groups). Treatment groups for each of their responses to the packages and would try to quit smoking within the target population (adults, young adults, advertisements. The ratings were next 30 days). In youth, the study and youth) viewed a hypothetical pack aggregated to create two scales: (A) An assessed whether the proposed required emotional reaction scale, which warnings may have a significant impact 2 While the numerical results reported in the included ratings on how the warning on potential initiation, using a measure study report (Ref. 49) were correct, and while all of made the respondent feel, such as of how likely youth felt they were to be the results discussed in this rule are accurately ‘‘depressed,’’ ‘‘discouraged,’’ and smoking 1 year from now. described, some of the descriptors contained in the study report were in error. An errata sheet for the ‘‘afraid’’; and (B) a cognitive reaction As the study report (Ref. 49) explains, study report (Ref. 50), which lists all the errors and scale, which included ratings on what the outcomes examined were selected the corrections, has been prepared and is being the respondent thought about the based on established theories of message placed in the docket. These errors did not adversely warning, such as ‘‘believable,’’ processing and health-related behavior impact commenters’ ability to convey their 3 assessment of the images and the study results in ‘‘meaningful,’’ and ‘‘convincing’’. change, which suggest that immediate their comments. To the extent some comments emotional and cognitive reactions to included inaccurate statements about the study 3 Some additional cognitive measures, including messages, and recall of messages, are results in their significant comments as a result of the reaction item ‘‘the pack was difficult to look at’’ part of a process that eventually leads to the errors, we recognized the inaccuracy and were (or, for the adult sample viewing the print ad, ‘‘the able to discern the material points in the comment ad was difficult to look at’’) were also evaluated but and evaluate them appropriately, as is reflected in were not reported as part of the composite cognitive correlated with the other cognitive measures to the comment summaries and responses. reaction scale. These items were not sufficiently include in the composite measure.

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changes in beliefs and intentions and more eventual behavioral outcomes, surveillance to assess actual long-term ultimately to behavior change. were considered to be more meaningful effects. than the results on the beliefs and 2. Use of FDA’s Research Study Results (Response) We agree that the study intentions measures in discriminating in Selection of Images design does not permit us to reach firm between the images. conclusions about the long-term, real- As described in section III.A of this In addition, we gave greater weight to world effects of the proposed required document, in order to determine which outcomes on the salience measures than warnings on the measured outcomes. As color graphic images to require in the to outcomes on the statement recall noted previously, the purpose of the final rule, we considered a number of measures for several reasons. First, there study was not to assess actual effects but factors, including the results from our is evidence to suggest that, while recall to assess the relative effects of the research study. We carefully examined of associated warning message proposed required warnings on various the research results for the 36 proposed statements may be reduced in the short outcomes. Data on the relative effects of required warnings on all the different term by moderately or highly graphic the various proposed required warnings outcomes in determining which images pictorial warnings versus text-only provided a more objective and scientific to require in this final rule. However, controls or less graphic pictorial basis to help select which required the responses on the salience measures warnings, these warnings still increase warnings should be included in the served as a primary basis for intentions to quit through evoked final regulation. A cross-sectional distinguishing among the 36 proposed emotional responses (Ref. 52). Second, design with a single exposure under required warnings for a number of as described previously, participants in experimental conditions is appropriate reasons. the research study were exposed to a for assessing relative effects. For First, many of the proposed required single viewing of the proposed required absolute effects, the scientific literature warnings elicited significant impacts on warnings, which does not allow for presented in the preamble to the the salience measures (emotional and assessment of the effect that repetitive proposed rule provides a substantial cognitive measures), which the research basis for our conclusion that the literature suggests are likely to be viewing of the required warnings may required warnings will effectively related to behavior change (Ref. 51). For have on recall. Recall can be expected communicate the health risks of example, the literature suggests that risk to increase in real world settings where smoking, thereby encouraging smoking information is most readily consumers will be exposed to the communicated by messages that arouse warnings multiple times. Third, recall cessation and discouraging smoking emotional reactions (see Ref. 45), and was generally high for all the proposed initiation. that smokers who report greater negative required warnings, even where there However, we recognize the value of emotional reactions in response to was not a significant difference conducting an ongoing evaluation of the cigarette warnings are significantly more compared to the text-only control or effects of the required warnings after likely to have read and thought about where recall was significantly lower for they enter the marketplace, and we the warnings and more likely to reduce the proposed required warning than for intend to monitor and evaluate their the amount they smoke and to quit or the text-only control. For example, for ability to effectively communicate the make an attempt to quit (Ref. 44). The the nine required warnings that we negative health consequences of research literature also suggests that selected for use in this final rule, the smoking. This evaluation will provide warnings that generate an immediate research study shows that recall of both information regarding whether the emotional response from viewers can the textual warning statements and the required warnings effectively reach the result in viewers attaching a negative color graphic images was high at both appropriate target audiences, wear out affect to smoking (i.e., feel bad about baseline and at 1-week follow-up, of the required warnings, and whether smoking), thus undermining the appeal exceeding 50 percent on all measures, and what changes to the required and attractiveness of smoking (Ref. 45 and, in many cases, exceeding 80 warnings may be appropriate in any and Ref. 40 at pp. 37–38). percent. future rulemaking on this subject. In comparison to the salience 3. Comments on FDA’s Research Study (Comment 23) A comment from measures, fewer of the proposed tobacco product manufacturers stated required warnings elicited significant FDA received a number of comments that a longitudinal study demonstrating impacts on the beliefs measures in our related to its research study in the that the required warnings would have research study, and on the whole the docket for the proposed rule, which are actual effects on smoking prevalence proposed required warnings did not summarized and responded to in the was necessary to support the final elicit strong responses on the intentions following paragraphs. regulation. measures. Given the design of our a. Study design. Several comments (Response) We appreciate the value of research study, where participants had addressed the cross-sectional design of longitudinal studies but disagree that only a single exposure to one proposed the study. such a study is necessary to support the required warning, it is not surprising (Comment 22) Several comments, final regulation. As discussed that the proposed required warnings did including comments from cancer previously, our research study assessed not consistently show effects on these researchers, nonprofit organizations, the relative efficacy of the 36 proposed beliefs and intentions measures, which and academics noted that participants required warnings published with the are more eventual outcomes in the in the study were exposed to a proposed NPRM, and the cross-sectional study behavior change process than the required warning only once in a design was appropriate for that purpose. salience responses, which occur more controlled environment. These The scientific literature presented in the immediately. However, this does limit comments stated that the single preamble to the proposed rule provides the utility of these longer-term measures exposure study design makes it a substantial basis for our conclusion in discriminating across the proposed impossible to assess long term or actual that the required warnings will required warnings. Thus, given the effects of the proposed required effectively communicate the health risks design of the study, the results on the warnings. Two of these comments of smoking, thereby encouraging salience measures, which the research recommended that FDA conduct smoking cessation and discouraging literature indicates are predictors of longitudinal research or post-market smoking initiation.

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(Comment 24) Several comments (see 75 FR 69524 at 69531 through graphic health warnings that elicit discussed behavioral models similar to 69533). These comments provide strong emotional reactions, especially that described in FDA’s research study additional support for that conclusion. negative feelings, are more effective in (see Ref. 49) and explained how those b. Study results. Several comments communicating the negative health models provide a rationale for how discussed the results from FDA’s consequences of smoking and in health warnings can effectively research study. motivating healthier behaviors than communicate risk information about the (Comment 25) Several comments, warnings that do not elicit emotional harmful effects of tobacco use. For including comments from academics, reactions, and indicate that these effects example, one comment from a nonprofit organizations, and health are well established in the scientific researcher working on an international professional organizations, stated that literature. project to evaluate the impact of graphic FDA’s research study provides data For example, one comment stated that health warnings for tobacco products consistent with the overall literature the scientific literature shows that stated that the primary objectives of demonstrating the effectiveness of graphic depictions of the negative health warnings are to educate and graphic health warnings. For example, health effects of smoking arouse inform smokers and nonsmokers about one comment stated that in general the reasonable fears and are associated with the many negative health consequences study results are consistent with prior greater consideration of health risks, of smoking and to provide information findings that the addition of graphic increases in motivations to quit, and that can enhance their efficacy for images to health warnings is beneficial ultimately with attempts at cessation. quitting. The comment noted that in comparison to text-only warnings. Another comment stated that theoretical effective health warnings increase Another comment stated that, based models and studies in communications knowledge and thoughts about the upon the FDA study and the existing and social psychology suggest that harms of cigarettes, the extent to which scientific literature, it is possible to graphic health warnings can be effective the smoker could personally experience conclude that the proposed graphic because they elicit greater emotional a smoking-related disease, and as a warnings are likely to be effective. engagement with the information Other comments, including comments result, increase motivation to quit provided and it is that engagement that from tobacco product manufacturers, smoking. Another academic who also is drives behavior change. Another advertising industry associations, and a conducting research on graphic health comment from an academic researcher public policy organization, asserted that warnings commented that a wide stated that considerable psychological FDA’s research study fails to provide variety of research suggests that health research suggests that risk is more evidence of efficacy. These comments warnings with pictures are significantly readily communicated by information stated that the study did not show more likely to draw attention, result in that arouses emotional associations with evidence that the proposed required greater information processing, and the activity. Emotional reactions can be warnings would actually affect improve memory for warnings than text- readily accessed from memory by mere prevalence of smoking, and failed to only warnings. A comment from a presentation of the stimulus, and appear demonstrate sufficient evidence that the to be powerful predictors of smoking researcher with expertise in risk proposed required warnings would perceptions and decisionmaking stated behavior. Yet another comment stated significantly affect consumer knowledge that growing evidence from controlled that changes in smoking behavior based of the risks of smoking or actual on warning labels appear to require four experiments and survey research behavior change. indicates that, compared to text-only steps: (1) Immediate, negative affective (Response) We agree that the study is warnings, graphic health warnings reactions to the potential consequences generally consistent with the existing evoke stronger emotional responses and of smoking; (2) associations of these scientific evidence demonstrating that increase motivations to quit or not start emotional reactions to smoking cues; (3) graphic health warnings can effectively smoking. The comment indicated that increases in perceptions of the risks of communicate the negative consequences these studies are consistent with smoking, and finally (4) increases in of cigarette smoking, and by doing so, cognition and neuroscience research quit contemplation and reductions in can encourage smoking cessation and demonstrating that relative to linguistic smoking behaviors. discourage smoking initiation. We or text information, imagery-based (Response) We agree that the design of disagree that the study results do not information can be processed more our research study is consistent with support the efficacy of the warnings. We rapidly, evoke stronger emotional established social science models (in presented substantial research in the responses, induce greater cognitive psychology, economics, and related preamble to the proposed rule processing and attitude change and can fields) of risk communication and supporting the efficacy of graphic health be recalled more easily. health behavior change. The purpose of warnings (75 FR 69524 at 69531 through However, other comments stated that graphic health warnings is to effectively 69534), and the results of our research reliance on emotional measures for communicate the negative health study are consistent with that research. assessing graphic health warnings is consequences of cigarette use to c. Study outcome measures. inappropriate. A joint comment from smokers and nonsmokers, which is Numerous comments discussed the key tobacco product manufacturers stated critical given the seriousness of these outcomes measured in FDA’s research that the study measured only the effect consequences. Greater understanding of study. of eliciting strong emotional and those health effects will motivate some (Comment 26) FDA received a wide cognitive reactions, which confirms that smokers to stop smoking and prevent variety of comments concerning the use the warnings were intended not to some nonsmokers from starting to of emotional reactions to assess the inform consumers with purely factual smoke. The preamble to the proposed relative effectiveness of the proposed and uncontroversial information, but rule presented a detailed discussion of graphic warnings. A number of rather to shock consumers into adopting the scientific literature to substantiate comments, including those from the Government’s preferred course of our conclusion that graphic health academics, medical institutions, and conduct. Another tobacco product warnings can be an effective means of public health groups, supported the manufacturer commented that, to the communicating important health inclusion of emotional reaction extent FDA selected images based on information about the risks of smoking measures. These comments stated that emotional or cognitive reactions and not

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on ability to inform consumers about informed and healthier behaviors, such required warnings may be perceived as the health risks of smoking, the as trying to quit smoking or deciding not unrealistic because they did not vividly regulations would not pass to start. portray immediate health risks, which constitutional muster. A comment from (Comment 27) We also received two could lead some smokers to discount a public policy organization commented comments concerning the cognitive the warning. The comment recognized that emotional and cognitive responses measure used in the study. A comment that a believability measure was are irrelevant measures of effectiveness filed by tobacco product manufacturers included in the study as part of the if there is no behavior response. observed that ‘‘looks cool’’ was one of cognitive reaction scale, but stated that (Response) On the basis of our review the measured cognitive reactions. The specific results for believability were of the relevant scientific literature and comment stated that the study analysis not reported, and recommended that the feedback received in the docket, we omits responses on whether the FDA examine the mean scores of the conclude that our inclusion of warnings ‘‘looked cool,’’ and contended specific believability items in emotional reaction measures to evaluate that if a substantial number of conjunction with other important the relative effects of the 36 proposed participants viewed a warning as ‘‘looks measures included in the study. required warnings was appropriate and cool,’’ the warning would be unlikely to (Response) We agree with the is consistent with well-established have the intended effect. The comment comment that believability is a helpful principles in the scientific literature. As concluded that the ratings for the ‘‘looks measure for assessing the relative discussed in the study report that was cool’’ measure do not appear to have effectiveness of warning images. All of placed in the docket (Ref. 49) and in been neutral; the comment stated that the selected images scored significantly other comments summarized in regression results for the ‘‘looks cool’’ higher than the controls on the previously in this document, eliciting measure indicates that this measure cognition measures, which included strong emotional and cognitive reactions elicited one of the strongest estimated ratings on how meaningful the warning to graphic warnings enhances recall and effects of the study and the results go in was, whether it was informative, and information processing, which helps to the opposite direction of effectively whether it was believable. While the ensure that the warning is better communicating health risk information. results do not include mean scores for processed, understood, and (Response) We disagree that data believability and other individual remembered. Thus, these responses can concerning the ‘‘looks cool’’ outcome measures, the appendices include the enhance the effective communication of was omitted or that the results for this parameter estimates from regression the health warning message. These outcome go in the opposite direction of analyses on these individual measures. responses in turn influence short-term the intended effect of communicating The results show that, in most cases, the outcomes, such as later recall of the the negative health consequences of images selected for the nine required message and changes in knowledge, smoking. Although the ‘‘looks cool’’ warnings scored significantly better attitudes, and beliefs related to the outcome was not included in the than the control with respect to dangers of tobacco use and exposure to reported composite cognitive measure, believability. secondhand smoke. As attitudes and the study report (Ref. 49) includes the (Comment 29) One comment stated beliefs change, they eventually lead to results for this measure in its that the statement recall measure is less changes in intentions to quit or to start appendices. The measure was reverse important and less relevant to decisions smoking and then later can lead to coded, so that a higher value about smoking than negative affective lower likelihood of smoking initiation corresponded with the intended reactions because the warning and greater likelihood of successful directionality for other measures. Thus, statements are now believed by smokers cessation. a high value for ‘‘looks cool’’ and nonsmokers. We disagree that use of emotional corresponds to a response of ‘‘strongly (Response) Statement recall was reaction measurements demonstrates disagree’’ from the respondent. The data appropriately included as part of the the Agency’s intent to advocate a presented in the appendices assessment of the relative effectiveness preferred position or course of conduct. demonstrate that for each of the nine of the 36 proposed required warnings. Each of the nine graphic warnings selected required warnings, significantly As discussed in section II.C of this required by the final regulations more participants disagreed that the document, while both smokers and communicates negative health warning ‘‘looked cool’’ than participants nonsmokers have some understanding consequences of smoking that are well- who viewed the text-only control about some of the risks of smoking, established in the scientific literature. warning. Eight of the nine required there are significant gaps in their Consistent with the Tobacco Control warnings elicited significantly higher knowledge, including about the Act, the purpose of these required ratings than the text-only control magnitude and severity of the risks of warnings is to communicate effectively warning across all target audiences. smoking. We also note that, as and graphically the very real, Ratings for the ninth required warning, explained in section III.B.2 of this scientifically established adverse health which includes the textual statement document, although we carefully consequences of smoking. The overall ‘‘WARNING: Quitting smoking now examined the research results on all the body of scientific evidence indicates greatly reduces serious risks to your study measures for the 36 proposed that health warnings that evoke strong health,’’ show that significantly more required warnings, including recall, the emotional responses enhance an adults disagreed that the selected responses on the salience measures individual’s ability to process the required warning ‘‘looked cool.’’ served as a more important basis than warning information, leading to Responses for young adults and youth recall for distinguishing among the 36 increased knowledge and thoughts were in the appropriate direction, but proposed required warnings. about the harms of cigarettes and the the responses were not significantly (Comment 30) A joint comment extent to which the individual could different from the text-only control submitted by tobacco product personally experience a smoking-related warning. manufacturers asserted that the study disease. Increased knowledge and (Comment 28) We also received a fails to demonstrate that the published thoughts about the negative comment concerning the believability graphic warnings will have any consequences of smoking, in turn, are measure. This comment raised a discernible effects on smoking risk reasonably likely to result in more concern that some of the 36 proposed beliefs.

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(Response) We disagree with this concerning intentions in FDA’s research longitudinal study on graphic health comment. Four of the nine selected study is an indication that the required warnings states that studies show that required warnings did show a warnings will not be effective. For graphic depictions of smoking’s adverse significant impact on beliefs about the example, a comment submitted by effects on the body are associated with health risks of smoking relative to the tobacco product manufacturers stated greater consideration of health risks, text-only control among at least one that the results of FDA’s research study increases in motivations to quit study population. In addition, there is show that graphic health warnings will smoking, and ultimately, attempts at substantial evidence in the scientific not result in a statistically significant cessation. A comment by a researcher literature showing that graphic health reduction in youth initiation or overall with expertise in risk perceptions and warnings effectively increase consumer prevalence of smoking, and thus, decisionmaking concludes that understanding of the health risks of confirms that the warnings will not be emotional associations to smoking smoking. In the preamble to the effective. appear to be powerful predictors of proposed rule (75 FR 69524 at 69531 (Response) We disagree that our study smoking behavior and may well be through 69533), we presented results indicate that the required causally implicated in efforts to either substantial research showing that warnings will not be effective. It is stop or start smoking. graphic health warnings significantly important to recognize that FDA’s (Comment 33) A comment from increase consumer thoughts about and research study was not designed or tobacco product manufacturers stated understanding of the health risks of intended to produce evidence that the responses to the ‘‘smoking smoking after they were introduced in demonstrating actual effects on urges’’ questions included in the study other countries. In addition, as behavior. Rather, the study was would provide a better measure for discussed previously in this document, designed to provide data concerning the assessing whether the proposed considerable scientific evidence shows relative effects of the graphic health required warnings affected smoking that health warnings that elicit strong warnings in order to provide a more behavior and, referring to the responses emotional and cognitive reactions are objective and scientific basis for our regarding these questions, the comment better processed and more effectively selection of the set of nine required asserts that, on balance, seeing the communicate information about the warnings in the final regulation. There proposed required warnings increased negative health consequences of is considerable evidence in the the desire to have a cigarette rather than smoking. Each of the nine required scientific literature demonstrating that decreased it. warnings elicited strong effects on the graphic health warnings effectively (Response) We disagree that our emotional and cognitive reaction scales, increase awareness of the health risks of research study shows that, on balance, which indicates that these warning will smoking, which is the principal purpose seeing the proposed required warnings effectively communication information of the warnings, and that this awareness increased the desire to have a cigarette. about the negative health consequences in turn can influence smoking The ‘‘smoking urges’’ measures were of smoking. intentions and behaviors. We included reverse coded, so that a higher value Based on the results of our research significant research to substantiate this corresponded with the intended study and the existing scientific conclusion in the preamble to the directionality for other measures in the literature, we conclude that graphic proposed rule (see 75 FR 69524 at 69531 study. Thus, a high value corresponds to health warnings, including the nine through 69533). For example, as a response of ‘‘strongly disagree’’ from selected required warnings, are likely to discussed in the proposed rule, a 2007 the respondent. The data presented in increase consumer knowledge and report from an expert IOM panel that the study report appendices (Ref. 49, understanding of the health risks of evaluated the existing scientific study report) show that, for three of the smoking. evidence on health warnings concludes nine selected required warnings, (Comment 31) A comment submitted that the available scientific evidence significantly more participants in at by tobacco product manufacturers indicates that larger, graphic health least one target group disagreed with the criticized the study’s use of intentions warnings would promote greater public statement that they wanted a cigarette to measure behavioral change and stated understanding of the health risks of than participants exposed to the text- that FDA should have presented data using tobacco and would help to reduce only control warning. For one of the showing actual effects on behavior. consumption (Ref. 3). selected required warnings, significantly (Response) We disagree that FDA’s research study cannot be more adult participants who viewed the intentions are an inappropriate variable viewed in isolation from the overall warning on a cigarette pack disagreed for assessing potential behavioral body of scientific evidence evaluating that they wanted a cigarette, but changes. While measures of intended the efficacy of graphic health warnings. significantly more adults who viewed behavioral outcomes do not perfectly While the research study itself did not the warning in a cigarette advertisement predict a future behavior outcome, it is provide evidence of strong effects on agreed. For one of the selected required a necessary precursor. The scientific intentions (which, as noted in section warnings, significantly more literature indicates that one’s intentions III.B.2 of this document, is not participants in one target audience to quit smoking must be increased surprising given the single-exposure agreed that they wanted a cigarette than before one makes the actual quit design of the study), the overall body of participants exposed to the text-only attempt. Thus, we conclude that it was scientific literature does provide control warning. Results for the appropriate in our research study to sufficient evidence that the required remaining selected required warnings assess quit intentions as a proxy for warnings, by increasing public and sample groups were not behavior change. In accordance with understanding of and thoughts about the significantly different from the text-only Executive Order 13563, after the rule is health risks of smoking, will be effective control warning. in effect we will be undertaking analysis in encouraging smoking cessation and Thus, on balance, the study does not to better understand the behavioral discouraging smoking initiation. show that exposure to the final set of effects of the warnings. A number of comments provide nine images increased the desire to (Comment 32) Several comments additional support for our conclusion. smoke a cigarette among study raised concerns that the lack of strong For example, a comment from a participants. As discussed in the statistically significant results researcher conducting an international previous response, the overall body of

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scientific literature provides ample (Response) We disagree that the study the potential for selection bias, we evidence that the required warnings, by results are invalid due to the disagree that this potential bias was increasing public understanding of and demographic composition of the likely to significantly affect the results thoughts about the health risks of sample. The research study was not of the study. Even if participants who smoking, are likely to encourage intended to be a survey of the national approve (or disapprove) of FDA were smoking cessation and discourage population, but rather a study using more likely to participate in the study, smoking initiation. Data from our random assignment to study conditions. one would expect that bias would affect research study regarding ‘‘smoking The study included individuals from all of the experimental conditions, urges’’ provide no basis for calling into certain target groups, particularly including the text-only control question that evidence. current smokers and youth who may be warnings. A bias of this sort would d. Study limitations and issues susceptible to initiation of smoking. affect the absolute effects of the regarding methodology. A number of Statistical methods were used to assess warnings in general, but not the pattern comments discussed a wide variety of the relative impact of each of the of relative effectiveness of individual issues concerning limitations of FDA’s proposed required warnings on various warnings. As a result, selection bias research study and raised various issues outcomes, rather than to assess the does not invalidate the results of the concerning the study methodology. absolute impact one would expect to study, which provides insight on the (Comment 34) Several comments, observe in the U.S. population as a relative effectiveness of the various including comments from health whole. warnings under consideration. institutions, nonprofit organizations, (Comment 36) One comment raised a (Comment 38) A comment from and academics, raised concerns that the concern that lack of adequate pretesting tobacco product manufacturers stated demographics of FDA’s research study of the proposed required warnings that FDA’s research study is seriously did not include adequate sample sizes evaluated in FDA’s research study could flawed because 32 percent of the for minority populations and persons of compromise the overall effectiveness of participants dropped out of the study lower income or lower education status. the pool of images tested. The comment before completing the questionnaire. These comments noted that the findings stated that it would have been more The comment stated that quitting the of the study therefore may not be helpful to conduct pilot testing with a survey was not likely to be a random relevant to populations with high very large group of images (at least 20 event and may have been a result of smoking prevalence and to those per textual warning statement) to ensure smokers who are not receptive to consumers who might be most impacted testing and selection of the most graphic health warnings dropping out. If by graphic health warnings. Some of the effective graphic warnings. so, the comment suggested that this comments recommended further testing (Response) We agree that more would have significantly overstated the in these populations. extensive pretesting may have been results of the study. (Response) We recognize the useful. However, we disagree with the (Response) We disagree that the drop- importance of reaching populations suggestion that the overall effectiveness out rate observed in the study with high smoking prevalence, of the required warnings could be undermines the validity of the results of including various racial/ethnic groups compromised by the inability to the study. Table 3–1 from the and persons of lower income or lower conduct additional pretesting prior to methodology report displays the total education status. The study report the research study. The results of the number of individuals entering the provides analyses of the relative effects research study as well as research study. However, these values represent of the images within various sub-groups, submitted by others during this the total number of individuals who separating samples by gender, race, and rulemaking proceeding indicate that the entered the study’s ‘‘landing page,’’ education. The analyses, for the most overall efficacy of the pool of proposed which is the site to which invitees link part, confirm that the relative effects of required warnings is quite strong. Based from the e-mail invitation. The the images are consistent across groups. on those data, as well as the overall invitation from e-Rewards, as well as As such, we have determined that the scientific literature, we conclude that the landing page, refers to the study as required warnings will help to the required warnings will effectively a ‘‘Study about Consumer Products.’’ effectively convey the negative health communicate the negative health There were no references to FDA, consequences of smoking to a wide consequences of smoking to smokers smoking, or tobacco in either the range of audiences, including different and nonsmokers. invitation or the landing page. Though racial and ethnic populations and (Comment 37) A comment submitted it is true that a number of invitees chose different socioeconomic groups. by tobacco product manufacturers not to continue after seeing the (Comment 35) A comment from asserted that selection bias is a serious invitation or the landing page, their tobacco product manufacturers methodological flaw of the study. The decision not to participate cannot be criticized the study methodology comment stated that participants were attributed to a bias for or against FDA because it did not include a nationally recruited from an Internet panel and or the implementation of graphic health representative sample of participants offered the opportunity to participate in warnings on cigarettes. and claimed that this failure biased the the research study, creating a selection In addition, the number of individuals study results. The comment stated that bias that was compounded by the fact identified as ‘‘Quits’’ in table 3–1 of the the study report (Ref. 49, study report) that the invitation to participate stated methodology report includes fails to disclose basic sampling that the study was funded by FDA. The individuals who quit after viewing the information and provides no indication comment noted that there is no landing page and those who quit after that those conducting the study adjusted indication that the study corrected for having been informed of FDA’s for the effect of choosing participants by the selection bias and opines that one involvement and that the survey soliciting volunteers. The comment would not expect the selection bias to concerned smoking or tobacco. Of those concluded that this failure was be neutral given the identification of individuals identified as ‘‘Quits’’, only a significant because the participants in FDA as the sponsor of the study. very small number were in the latter the study may not reflect the population (Response) We disagree that selection group (i.e., quit after being informed of of interest and may bias the statistical bias is a serious methodological flaw of FDA’s involvement and that the survey estimates. the study. Although we acknowledge concerned smoking or tobacco). For

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example, of the 13,673 respondents who the study report (Ref. 49, study report)), required warnings increased awareness entered the adult pack survey (the point most of the youth were sampled from a of the health effects of smoking. in time when they viewed the study’s separate youth panel, which was (Response) The lack of an assessment landing page), 2,179 chose at some point independent of the adult panel. Some of of baseline knowledge does not make to discontinue. Of these, only 148 the youth were sampled from the the study results less reliable or invalid. individuals, or about 1.1 percent of households of the adult panel. However, In a study such as FDA’s research study, those entering the study, chose to those in the latter group were sampled responses to the control conditions discontinue the survey after being independently and randomly from the serve as proxies for baseline knowledge, informed of FDA’s involvement and that adults that participated in the study. awareness, beliefs, and intentions. the survey concerned smoking or Although possible, it is unlikely that Comparing the treatment responses to tobacco. A similar pattern exists for all both a parent and child from a single those of the control allow for an of the study samples: In the adult pack household received an invitation for the assessment of the potential impact the follow-up sample 23 individuals, or 0.6 study and completed the study. treatment has on baseline measures. percent, chose to discontinue after being (Comment 41) A comment from C. Comments to the Docket informed; in the adult ad study sample tobacco product manufacturers objects 193 individuals, or 2.1 percent, chose to to the manner in which the study FDA received hundreds of comments discontinue after being informed; in the assessed emotional and cognitive on the 36 proposed required warnings; the comments relating to each proposed adult ad follow-up sample 26 reactions. The comment states that the required warning are discussed in individuals, or 0.7 percent, chose to study weighted the responses to sections III.D and III.E of this document. discontinue after being informed; in the multiple questions, but fails to disclose Some comments discussed the 36 young adult study sample 152 the weights used and the justification proposed required warnings generally or individuals, or 1.3 percent, chose to for those weights, and states that discussed different styles or themes discontinue after being informed; in the without information on the weighting used in the set of proposed required young adult follow-up sample 11 system, one cannot assess these warnings. These comments are individuals, or 0.3 percent, chose to measures for bias. discontinue after being informed; in the summarized and responded to in this (Response) We disagree with this section. youth study sample 104 individuals, or comment. Section 4.2 of the 0.3 percent, chose to discontinue after As explained in section III.A of this methodology report for our research document, we considered the comments being informed; and in the youth study (included in the docket as part of follow-up sample 13 individuals, or 0.5 submitted to the docket as we the study report (Ref. 49, study report)) determined which color graphic images percent, chose to discontinue after being indicates that a factor analysis was used informed. The drop-out rate, as to require to accompany the nine textual to determine the appropriate items to warning statements in the final rule. We calculated here, varies across the study include within each scale. A weighting samples but never exceeds 2.1 percent. did not simply count the number of scheme was not used. Rather, items comments received supporting or Therefore, we do not agree that the were combined using a simple drop-out rate invalidates the results of opposing the use of a particular image summative scale. Use of a simple as a way to measure the relative the study. summative scale is a widely-used (Comment 39) A comment from effectiveness of our proposed images or method of analyzing these data. tobacco product manufacturers stated of images recommended by comments, that the youth component of FDA’s (Comment 42) A comment from but rather evaluated the substantive research study is subject to a response tobacco product manufacturers states input contained in the comments to bias. The comment stated that the study that the study used an inappropriate help inform our decisions in selecting or failed to address the risk that the youth methodology by measuring risk not selecting a particular image and to participants might alter their responses awareness and smoking intentions on a obtain other relevant information due to a concern that their parents scale. The comment states that related to research on the images. Many might see the results. evaluating these measures on a scale is of the comments contained information (Response) We disagree that the youth inappropriate for testing awareness of a about the submitter’s personal opinions, sample is likely subject to a response fact and also resulted in the authors beliefs, and attitudes related to various bias. Youth participants were told at the making subjective and undisclosed images. While this information is outset of the study that their responses decisions about how to weight those helpful in understanding how people would be kept confidential. Once the values. might interpret various images and in study was complete, other household (Response) We disagree. It is raising issues for further exploration, members could not retrieve those appropriate to measure the impact of a this type of qualitative information is responses. Moreover, if youth warning on the strength of an not as useful as quantitative assessments participants were concerned about individual’s awareness, beliefs, and of the relative effectiveness of the 36 parental awareness of their intentions. To do this, one must use a proposed required warnings at participation, it would likely have scaled response, rather than a conveying information about the resulted in a decision not to participate dichotomous response, to each question. negative health consequences of rather than a decision to alter their In the research study, items were not smoking, such as the assessment responses. weighted within each scale. Rather, they provided in FDA’s research study. (Comment 40) A comment from were combined using a simple Furthermore, as described in more tobacco product manufacturers raised a summation of ratings. This is a widely- detail in the comment summaries and concern that the youth sample is subject used methodology for this type of study. responses in sections III.D and III.E of to a selection bias because participants (Comment 43) A report attached to the this document, some of the information were derived from families whose comment from tobacco product contained in comments that criticized or parents also participated in the study. manufacturers criticizes FDA’s research opposed the use of various proposed (Response) We disagree. As discussed study for failing to assess baseline images suggested that the images evoked in section 2.2.3 of the methodology knowledge among participants to negative emotional reactions in the report (included in the docket as part of determine whether the proposed viewer. The research literature,

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however, suggests that warnings that the textual warning statements required students, including smokers, evoke these reactions can increase the by the Tobacco Control Act. Each set nonsmokers, and ‘‘vulnerable’’ likelihood smokers will reduce their included each of the proposed required nonsmokers. The study assessed smoking, make an attempt to quit, or warnings published with the proposed emotional reactions, risk perceptions, quit altogether (Ref. 44). rule for use with the specific textual and smoking aversion. Participants were warning statement as well as at least one randomized into four conditions, with 1. Comments Submitting Research on alternative warning. Each participant each viewing 18 graphic warnings. Two FDA’s Proposed Required Warnings was randomly assigned to view and rate conditions viewed graphic warnings We received several comments, two sets of health warnings. being used in other countries, one including comments from academics, a Warnings within each set were first condition viewed 18 graphic warnings nonprofit organization, and a prevention rated individually on a scale of 1 to 10 published with the proposed rule, and specialist, that described the results of and then participants were asked to the fourth condition viewed the scientific investigations that the rank order the entire set for perceived proposed FDA graphic warnings plus submitters had conducted to examine effectiveness for discouraging smoking. three graphic warnings from other the potential effectiveness of FDA’s The comment presented the rating and jurisdictions. According to the proposed required warnings on various ranking scores for the health warnings. comment, warnings ‘‘that were outcomes. We address that research and The comment also presented perceived as more graphic, more our responses to these comments in the preliminary statistical analyses for the intense, less good, and more fearful comment summaries and responses in overall ranking scores; statistical data produced more thoughts about not this section. The information contained were not presented for individual wanting to smoke.’’ The comment in these comments about particular ratings for the individual measures concludes that, compared to the viewed proposed required warnings is also assessed. The comment concludes that warnings being used in other countries, discussed as applicable in sections III.D preliminary results from the study show the FDA proposed required warnings and III.E of this document. that warnings that were more explicit did not maximize thoughts of health As is discussed in the summaries in about the health risks of smoking were risk perceptions or smoking aversion, this section, the nine required warnings rated as being more effective among although the differences between the we have selected for use on cigarette both adults and youth. The academic warnings from other jurisdictions and packages and in cigarette who conducted the study similarly FDA’s proposed required warnings were advertisements generally performed concluded that health warnings that marginal. well in the studies discussed in these were more explicit and that elicited (Response) The nine required comments. These comments indicate greater emotional reactions were rated warnings that we have selected that the findings from our own research as being most effective, and the performed relatively well in this study. study are robust, as they have generally researcher recommended that FDA Many performed as well as the warnings been confirmed under the various select certain graphic warnings that from other jurisdictions and some different study designs utilized in the received high rating and ranking scores performed better. It is difficult to assess research discussed in these comments. in the study (including required the results of this study more However, in contrast to our own warnings proposed by FDA as well as specifically, however, without research study, we did not have access graphic warnings that have been used in additional information concerning the to the raw data or to all the statistical other countries). study protocol, methods, and statistical analyses for the studies discussed in (Response) The results of this study analyses. these comments. In addition, the design are generally consistent with the results (Comment 46) A study was submitted of some of these studies did not allow of the scientific literature and the study by a group of behavioral scientists for an assessment of the relative sponsored by FDA. This study shows whose research focuses on cognitive, effectiveness of FDA’s 36 proposed that the existing cigarette warnings are emotional, and imagery processes that required warnings. This limited the not salient among either adults or youth. influence how people respond to utility of the information provided in Among other responses, 50.3 percent of messages about health risks. Their the submissions. adults responded that they never or experimental study evaluated the 36 Thus, while we carefully considered rarely noticed the health warnings on proposed required warnings published the information provided in these cigarette packs, while 23.7 percent with the proposed rule. Participants submissions, the results of our own stated that they often or very often were young adults ages 18 to 25, and study were more helpful in making noticed the warnings. Among youth, included smokers and nonsmokers. research-based selection choices. 63.3 percent responded that they never Each participant viewed 18 of the 36 (Comment 44) One study was or rarely noticed the health warnings on proposed required warnings and was submitted by a group from a medical cigarette packs, while 12.9 percent asked to rate each on the following institution and by a collaborating stated that they often or very often measures: Perceived comprehension, academic who has conducted research noticed the warning. The graphic worry about the health risks of smoking, on graphic health warnings. Participants warnings selected for inclusion in the and the extent to which the warning were recruited from an Internet panel of final regulation generally performed discouraged the participant from adults, young adults, and youth. The relatively well in both this study and in wanting to smoke a cigarette. The report for the study states that it was FDA’s research study. It is difficult to comment states that the study provides intended to assess the potential assess the results of this study more strong support that most of the graphic effectiveness of FDA’s 36 proposed specifically without additional warnings proposed by FDA are required warnings. Among other things, information concerning the study perceived by young adult smokers as participants were asked to provide protocol, methods, and statistical easy to understand, as enhancing worry certain demographic information as well analyses. about the health risks of smoking, and as information concerning their smoking (Comment 45) A study was submitted as discouraging young adult smokers status and attitudes and beliefs about by a researcher with expertise in risk from wanting to smoke. The comment smoking. In addition, the study tested perceptions and decisionmaking. states that the results of the study are nine ‘‘sets’’ of warnings, one for each of Participants were young adult college consistent with the growing body of

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evidence showing that, compared to (Comment 48) An organization of high highlighted issues that applied to some text-only warnings, graphic warnings school students submitted the results of or all of the proposed required can evoke stronger emotional responses a study they conducted to assess the warnings. These comments are and reduce motivations to smoke. efficacy of the 36 proposed required summarized and responded to in the (Response) The nine required warnings published with the proposed following paragraphs. warnings that we have selected rule. Organization members recruited (Comment 50) Many comments stated performed relatively well in this study. participants from their high schools and that graphic health warnings that elicit It is difficult to assess the results of this communities. Each participant viewed strong emotional responses are most study more specifically without 18 of the proposed required warnings effective in communicating the negative additional information concerning the and was asked to rate each warning for health consequences of smoking and in study protocol, methods, and statistical perceived effectiveness in stopping encouraging smoking cessation and analyses. someone from smoking. Findings were discouraging smoking initiation. Most of (Comment 47) A study was submitted reported as arithmetic means and these comments recommended that FDA by two researchers at a university-based modes. The comment concludes that select the warnings that evoke the public policy center. The comment study respondents generally believed strongest emotional responses. Some of states that the study, of young adult and that the most effective images were the these comments cited graphic warnings adult smokers, was conducted to assess more graphic images. used in other countries or international limitations of the FDA study and to (Response) We note that the nine research showing that images that identify ways to increase the impact of required warnings we selected generally trigger emotional responses promote the warnings. The study used the same rated highly in this study. greater awareness and better (Comment 49) One comment online survey firm as that used in the recollection of the health risks of contained the results of a study FDA study, although respondents who smoking. Some of these comments also conducted by two individuals among participated in the FDA study were not stated that warnings that trigger these college students at a U.S. university. In eligible to participate in this study. The responses retain their effectiveness this study, 63 college students, longer. Some of these comments study was limited to four of the nine apparently including both smokers and recommended that FDA select graphic warning statements required by the nonsmokers, were shown the 36 warnings that portray graphically Tobacco Control Act. The graphic proposed required warnings and asked disturbing images or images that evoke warnings assessed for each of these four to rate them on a scale of 1 to 7 on their fear or disgust. statements included some of the perceived effectiveness in helping (Response) We agree that eliciting proposed FDA warnings, these same smokers’ intent to quit. According to the strong emotional responses helps proposed warnings with additional text comment, certain demographic communicate health information. The or color added, and some graphic information also was obtained from overall body of scientific literature warnings used in Canada. Graphic participants. The comment identifies indicates that health warnings that warnings were compared against a text- the five proposed required warnings evoke strong emotional reactions only control warning that appeared on that were ranked as being the most enhance an individual’s ability to the side of a cigarette pack. The study effective warnings and the five proposed process the warning information. This used two indices to assess efficacy. The required warnings that were ranked as leads to increased knowledge and first assessment was perceived being the least effective. According to thoughts about the health risks of effectiveness in discouraging someone the comment, demographic factors did smoking and the extent to which an from smoking. For the second not affect the rating scores. The only individual could personally experience assessment, participants were asked to factor identified as having an impact on a smoking-related disease, which can in imagine themselves smoking a cigarette rating was smoking status, with turn motivate positive behaviors. For and then to report how good or bad they participants who had a history of example, the literature suggests that risk would feel smoking a cigarette. The smoking more likely to rate the graphic information is most readily comment states that in three of the four warnings as being effective than subjects communicated by messages that arouse warning messages required by the who did not have any history of emotional reactions (see Ref. 45), and Tobacco Control Act, a single exposure smoking. that smokers who report greater negative to a large graphic warning was more In another comment, submitted by a emotional reactions in response to effective in creating immediate negative self-identified prevention specialist cigarette warnings are significantly more emotional associations with the act of from a U.S. public school district, 1,339 likely to have read and thought about smoking than exposure to the text-only high school students viewed the 36 the warnings and more likely to reduce warning. The comment states that the proposed required warnings and were the amount they smoke and to quit or study did not show that the single asked ‘‘which image would change your make an attempt to quit (Ref. 44). The exposure affected immediate plans to mind about smoking.’’ The comment research literature also suggests that quit smoking; the authors of the identified the ‘‘top three’’ proposed warnings that generate an immediate comment note that a brief test following required warnings. emotional response from viewers confer a single exposure is unlikely to detect (Response) We note that the proposed negative affect to smoking cues and this effect, and that they would expect required warnings chosen as ‘‘most undermine the appeal and attractiveness quit intentions to increase through effective’’ include some of the nine of smoking (Ref. 45 and Ref. 40 at pp. repeated exposures to the warnings. required warnings we selected. Neither 37–38). In FDA’s study, eight of the nine (Response) The proposed required of these comments included sufficient selected required warnings elicited warnings published by FDA and information or data with which to strong emotional reactions across all included in this study performed further assess the results or conclusions. target audiences. As is further discussed relatively well in this study. It is in section III.D of this document, the difficult to assess the results of this 2. Other Comments ninth selected required warning, which, study more specifically without FDA also received a number of other unlike the other eight required additional information concerning the comments that discussed the proposed warnings, contains a warning statement study and the statistical analyses. required warnings generally or that is framed in a positive manner, also

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showed significant effects on the were an effort to manipulate people to diminish the importance of the emotional reaction scale in one study stop smoking or not to start. warnings, with some asserting that this population. Given the manner in which (Response) We disagree. The set of style is contradictory to the serious this ninth warning is framed, it is not nine required warnings we selected messages being conveyed. One comment expected to arouse the same level of include a balanced set of images. Some believed that these warnings would response on the emotional reaction scale individuals may find certain images soften the message, while another used in FDA’s research study as the more visually disturbing than others. believed the graphic illustration other eight warning messages (see The images are not intended to shock or warnings were ‘‘harsh.’’ Some section III.D of this document). disturb, but rather to effectively educate comments stated that these warnings Some of the required warnings we and inform smokers and potential would negatively affect the believability selected include images that may be smokers about the serious health of the warnings and would not be taken more emotionally disturbing to certain consequences of smoking. Each of the seriously by youth. One comment individuals than others. As we nine graphic warnings communicates expressed concern that the graphic discussed in the preamble to the negative health consequences of illustration style images might resonate proposed rule, the use of health smoking that are well-documented in with youth, but would not be effective warnings with disturbing tonal qualities the scientific literature. By with young adults or adults. It was also appears to be effective (75 FR 69524 at appropriately conveying the serious noted in the comments that the images 69534). But research also indicates that health consequences in a truthful, presented in this style may other types of graphic images, including forthright manner, the images contain inadvertently suggest approval of some that individuals do not find information that may disturb some tobacco use to low-literacy populations frightening or disturbing, can also be viewers because the severe, life- that do not comprehend the effective in communicating the health threatening and sometimes disfiguring accompanying textual statement, and risks of smoking (Id.). The set of nine health effects of smoking are disturbing. that these images could allow smokers graphic warnings we selected includes a The overall body of scientific evidence to deny the health consequences that are balanced set of images in order to reach indicates that larger, graphic health presented. Another comment stated that the broadest target audience of smokers warnings will effectively communicate the research suggests ‘‘cartoon-style’’ and potential smokers. these risks. We do not agree that these images and overly conceptual images (Comment 51) Some comments raised warnings are disrespectful or degrading. are easily dismissed by smokers. concerns about the quality of the (Comment 53) A number of comments (Response) We disagree with the proposed required warnings published advocated for the selection of a set of contention that the use of graphic by FDA. Some believed that the images that could communicate with illustration style images is categorically proposed required warnings were the diverse U.S. population, and inappropriate. One of the required weaker than those used in other emphasized the importance of human warnings we selected is presented in countries, and thus, would be less diversity in the images, in part to help this style. As discussed in section III.B impactful than those in use in other ensure the images reach people of low of this document, our research study countries. A few comments said the socioeconomic status that are more shows that the selected required images were overdone and insulting, likely to be smokers and/or to have warnings, including the required and a few indicated that the submitters lower literacy. The comments stated warning that includes a graphic believed that the visuals were poorly that graphic health warnings are an illustration style image, showed strong crafted. especially important communication effects in terms of emotional reaction (Response) We disagree with these tool for these population groups. A few scale, cognitive reaction scale (including comments. We have chosen a balanced comments also raised concerns that not believability), and the ‘‘difficult to look set of images for use with the required enough of the 36 proposed required at’’ measure. Given these results, we warnings, and these warnings are warnings depicted younger people, and concluded that the graphic illustration generally consistent with the graphic indicated this could reduce their impact style can be an effective style for health warnings used in other countries. among youth. communicating the negative health risks The results from our research study and (Response) We agree that it is of smoking, including to a diverse range the overall body of scientific literature important to select a set of images that of viewers. In addition, it is important on graphic warnings provide a strong can communicate with the diverse U.S. to include a variety of different styles in basis for concluding that the nine population. As discussed in section the final set of warnings. As discussed selected required warnings will III.A of this document, we considered in the preamble to the proposed rule, a effectively communicate the negative the need for diversity when making varied set of warnings is consistent with health risks of smoking to smokers and image selections, and the images the scientific literature, facilitates better potential smokers. selected include a diversity of human targeting of specific groups whose (Comment 52) Some comments raised images (e.g., race, gender, age), as well interests may vary, and has been shown concerns that the proposed required as a diversity of styles (e.g., to be effective in delaying or warnings were too explicit and too photographic versus illustrative) and counteracting wear out of the warnings visually disturbing. Some of these themes. This is consistent with the (75 FR 69524 at 69534). comments raised concerns that the evidence base for graphic health (Comment 55) A number of comments images were too disturbing for children warnings from countries that have advocated that FDA select only required to see, and others indicated that already implemented such warnings warnings with photographic images. nonsmokers should not have to be (see Ref. 40 at p. 46 and Ref. 11). Some of these comments stated that the subjected to ‘‘gross’’ images when they (Comment 54) A number of comments use of photographic images was go into retail establishments. Two raised concerns that some of the important to realistically portray the comments raised concerns that images proposed graphic warnings included negative health consequences of that showed humans in distress or graphic illustration or ‘‘cartoon-style’’ smoking and to provide a real-life human remains were disrespectful and images. Some of these comments stated quality to the warnings. One comment degrading. One comment stated that the that these warnings might trivialize the stated that photographic images were proposed warnings crossed the line and serious health risks of smoking or needed to ensure that smokers and

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potential smokers understood that the smoking intentions. We disagree with warning messages, but rather to depicted health consequence could comments stating that required accompany textual warning statements. really happen and to provide a more warnings will not be effective. We have Although we disagree with the physical connection. One comment determined that the set of required contention in this comment that the stated that photographic images would warnings we have selected will images are only meaningful in be more engaging and remembered than effectively convey the negative health conjunction with the information in the images presented in other styles. One consequences of smoking, which will accompanying textual warning, the comment stated that warnings with help discourage nonsmokers, including images are required to be presented at abstract imagery that require individuals children and adolescents, from starting all times with this accompanying to ‘‘connect the dots’’ and draw to smoke cigarettes, and help encourage information. inferences present an unnecessary and current smokers to consider cessation to D. Selected Images counterproductive hurdle for viewers, greatly reduce the serious risks that and are unlikely to have an effect on smoking poses to their health. This section discusses the nine color smokers. (Comment 57) Several comments graphic images that we selected for use (Response) We agree that graphic stated that images that depict realistic with the textual warning statements set warnings with photographic images can suffering caused by tobacco use are forth in section 201 of the Tobacco effectively communicate the negative more effective in promoting cessation Control Act and the factors that health consequences of smoking, and than images that portray death. influenced each selection decision, most of the required warnings we (Response) We agree that graphic including the results from our research selected include photographic images. warnings that depict the realistic study, the substantive comments The existing scientific literature, the suffering caused by tobacco use can be received in the docket, the relevant experience of other countries, and the effective at communicating the negative scientific literature, and any other results of our research study show that health consequences of smoking, and considerations weighed, such as the graphic warnings using photographic some of the required warnings we diversity a particular image contributes images can effectively communicate the selected include such images. At the to the overall set of required warnings. negative health consequences of same time, we do not agree that such The document entitled ‘‘Proposed smoking. At the same time, we do not images are the only images capable of Required Warning Images’’ that was agree that photographic images are the effectively communicating the negative included in the docket for the proposed only style of imagery capable of health consequences of smoking. A rule displayed each of the 36 proposed effectively communicating these health balanced set of warnings with a variety required warnings (consisting of the risks. A balanced set of warnings with of image themes is most likely to proposed images and accompanying a variety of image styles is more likely maximize the effectiveness of the warning statements) on two consecutive to effectively reach a broad group of selected required warnings among a pages, with one display showing the target audiences, and we note that broad group of target audiences, and warning statement accompanying the graphic warnings used in many other notes that graphic warnings used in image in black text on a white countries include a mix of imagery, many other countries include a mix of background and one display showing it including photographic and other styles. imagery. As discussed in the preamble in white text on a black background. (Comment 56) Some comments stated to the proposed rule, the existing The images are referred to in this that graphic warnings will not be research indicates that the use of a section by the pages on which they effective in deterring smoking. One variety of health warnings broadens the appear in the ‘‘Proposed Required comment stated that smokers already reach of the warnings, and is effective Warning Images’’ document and by the know the health risks of smoking and in counteracting overexposure and descriptive names used for each image are very brand loyal, so graphic images delaying wear out of the warnings (75 in the study report (Ref. 49) will not affect their smoking decisions. FR 69524 at 69534). summarizing the results of our research Another comment stated that youth will (Comment 58) One comment stated study. not be deterred by pictures and the that most of the proposed images are In this section’s discussion of the graphic warnings could instead make illustrations rather than graphic results from our research study for each smoking more enticing to youth. One warnings, in that they are meaningful selected image, the endpoints that the comment stated that smokers are only to people who are already aware of images showed a statistically significant addicted to cigarettes and ‘‘flashy’’ the information in the accompanying effect on in one or more of the study pictures will not stop them from textual warning. populations (adult smokers aged 25 or smoking but instead will only encourage (Response) Consistent with the older, young adult smokers aged 18 to them to cover the pictures. On the other requirements of section 201 of the 24, and youth who currently smoke or hand, other comments concluded that Tobacco Control Act, we have who are susceptible to smoking aged 13 graphic health warnings are likely to developed color graphic images that to 17) are described. This discussion affect smoking decisions. One comment depict the negative health consequences also notes the level of significance of the stated that graphic warnings will deter of smoking to accompany the nine new effects by providing p-values: (p<0.05), initiation, and another stated that the warning statements provided by (p<0.01), and (p<0.001). The p-value is warnings will lead to a decrease in Congress in the Tobacco Control Act. reflective of the percent chance the cigarette sales. One comment stated that The graphic health warnings, referred to finding could have happened by graphic warnings will reach people who as ‘‘required warnings’’ in the NPRM coincidence. For example, for a finding otherwise would not read text-only and in this final rule, consist of the that is significant at 0.1 percent warnings. combination of each textual warning (p<0.001), there is less than one chance (Response) As previously discussed, statement and the accompanying color in a thousand that the finding happened we concluded that large graphic graphic image we selected for use with by coincidence. The full description of warnings are effective in conveying the each statement. The submitter of this our research study and the analyses are health risks of smoking, influencing comment seems to misunderstand how contained in the study report (Ref. 49, consumer awareness and knowledge of the images are to be used; they were not study report) that was placed in the those risks and having an impact on developed to serve as stand-alone docket for the proposed rule.

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The required warnings, consisting of summarized and responded to in the of comparative effectiveness of the 36 the nine color graphic images we following paragraphs. proposed required warnings at stopping selected and the textual warning (Comment 59) FDA received a large someone from smoking, and it received statements, are contained in a document number of comments supporting the use the highest overall rating of the images titled ‘‘Cigarette Required Warnings,’’ as of the image ‘‘hole in throat,’’ including examined for use with this statement in is further discussed in section V of this comments from individuals (including another submitter’s study of the document. former smokers), public health advocacy potential effectiveness of the images. groups, academics, State and local (Response) As discussed in section 1. ‘‘WARNING: Cigarettes are public health agencies, and health care III.C of this document, we carefully Addictive’’ professionals. Many comments stated considered the comments submitted to We selected the image which appears that this image is the best image for use the docket that described the results of on pages one and two of the document with this warning statement. Some studies conducted by the submitters on ‘‘Proposed Required Warning Images,’’ comments indicated that the image was our proposed required warnings. The referred to as ‘‘hole in throat,’’ for use appropriately compelling and results summarized in these comments with this warning statement. effectively communicates the risks of are generally supportive of our image In our research study, this image had smoking. Other comments stated that selection decisions. a significant effect (p<0.001) on all the image will be an effective deterrent (Comment 62) FDA also received salience measures (emotional reaction to smoking by making a smoker think some comments that opposed the use of scale, cognitive reaction scale, and twice before buying cigarettes and/or by the image ‘‘hole in throat.’’ One difficult to look at measure) in all three making children think twice before comment noted that the image was ‘‘too study populations (adults, young adults, starting to smoke. Several comments gross to be effective,’’ while another and youth). The image had the also indicated that the image concretely comment stated that it ‘‘offend[s] against numerically largest effects of the images conveys the health harms of smoking. human dignity.’’ In addition, one proposed for use with this warning (Response) We selected this image for comment stated that the image would statement on the emotional reaction use with this warning statement. only have a one-time shock value, and scale and the difficult to look at measure (Comment 60) One comment another comment indicated that the in all three study populations, as well supported use of this image in part image was too vague in nature. as on the cognitive reaction scale in because of the diversity reflected in the (Response) We disagree with these adults. As discussed in section III.B of image, and noted that it could be a comments. The image effectively and this document, these salience impacts Latino smoker or a man of color, which concretely communicates the negative are important, as the research literature could make it more relevant than other health consequences of smoking. The suggests that they are likely to be related proposed images with low image clearly portrays the addictive to behavior change. socioeconomic status smokers. Another nature of cigarettes, depicting a man The image also had a significant comment noted that the image targets a who is still smoking despite prior impact (p<0.05) on adult 4 beliefs about critical demographic group by evidence (a stoma in his neck) of the health risks of smoking for smokers, portraying an image of a man. surgery for cancer. As discussed, this and a significant impact (p<0.05) on (Response) We agree that it is image had a highly significant effect adult beliefs about the health risks of beneficial to have a diverse set of images (p<0.001) on all salience measures secondhand smoke exposure for that communicates with a wide range of (emotional reaction scale, cognitive nonsmokers, relative to the text-only audiences, including population reaction scale, and difficult to look at control. subgroups with higher smoking measure) in all three study populations However, young adults viewing the prevalence rates. In light of this, we (adults, young adults, and youth). The image had significantly lower statement selected a set of nine required warnings research literature indicates that images recall at one week follow-up than those (including the image ‘‘hole in throat,’’ that evoke emotional reactions can who viewed the text-only control (55.9 which portrays a man of color) that promote greater awareness and better percent versus 74.3 percent), as did includes a variety of human images that recollection of the health risks of adults viewing a hypothetical are broadly representative of the overall smoking, and can increase the advertisement containing the proposed population. likelihood smokers will reduce their required warning (64.1 percent versus (Comment 61) As mentioned in smoking, make an attempt to quit, or 87.7 percent). However, recall of the section III.C of this document, some quit altogether (Ref. 20, 44, and 45). statement was generally high for the comments submitted to the docket Furthermore, contrary to the assertion image (ranging from 55.9 percent to 86.3 described the results of scientific that the image will only have a one-time percent), even where it was significantly investigations that the submitters had shock value, the research literature lower than for the text-only control, and conducted to examine the potential suggests that more vivid warnings are we conclude that repetitive viewing of effectiveness of FDA’s proposed images more likely to retain their salience over the required warning is likely to on various outcomes. This image was time (Ref. 3 at p. C–4 and Ref. 41). increase recall. As explained in section discussed in some of these comments. III.C of this document, we gave greater For example, in one submitter’s study, 2. ‘‘WARNING: Tobacco Smoke Can weight to outcomes on the salience participants rated this image highly on Harm Your Children’’ measures than to outcomes on the recall its ease of comprehension. It also We selected the image which appears measures. induced relatively greater worry and on pages 9 and 10 of the document We received a number of comments feelings of discouragement from ‘‘Proposed Required Warning Images,’’ on this image, which we have wanting to smoke than a text-only referred to as ‘‘smoke approaching control. The submitter concluded that baby,’’ for use with this warning 4 Throughout this section, the results on this image was the most effective of the statement. individual study measures discussed for the adult images proposed for use with this In our research study, this image had study population are results from the adult sample a significant effect (p<0.001) on all the viewing the hypothetical cigarette package (as warning statement. Additionally, this opposed to the sample viewing the hypothetical image was one of two images deemed salience measures (emotional reaction advertisement), unless otherwise noted. effective in another submitter’s survey scale, cognitive reaction scale, and

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difficult to look at measure) in the adult research study, which exposed each with a wide range of audiences, and youth samples. In young adults, the participant to each image only once, and including a variety of population image also had a significant effect on all thus may not be able to accurately subgroups. In order to ensure that the the salience measures (emotional distinguish the relative effects of the final set of required warnings effectively reaction scale (p<0.01), cognitive images on more eventual outcomes, communicates risk information to a reaction scale (p<0.001), and difficult to such as changes in beliefs, as reliably as diverse range of audiences, we selected look at measure (p<0.05)). their effects on more immediate a set of nine required warnings, The image had a significant effect emotional and cognitive reactions. including the image ‘‘smoke (p<0.05) on recall of the warning However, the negative results observed approaching baby,’’ that includes a statement at baseline compared to the on the secondhand smoke beliefs variety of human images that are control for adults and youth. The image measure for the images ‘‘girl crying’’ and broadly representative of the overall also had a significant effect (p<0.05) on ‘‘girl in oxygen mask’’ were of concern, population. statement recall at 1 week follow-up in particularly given that the subject of the (Comment 65) As mentioned in young adults. The image also showed warning statement is the health risks of section III.C of this document, some some of the largest effect sizes for image secondhand smoke exposure for comments submitted to the docket recall (at baseline and at 1 week follow- children. Thus, ‘‘smoke approaching described the results of scientific up) in adults and young adults across baby’’ was considered a preferable investigations that the submitters had the images proposed for use with this alternative to these two images. conducted to examine the potential warning statement. Furthermore, ‘‘smoke approaching effectiveness of FDA’s proposed images The image had a statistically baby’’ was associated with youth on various outcomes. This image was significant effect (p<0.05) on youth reporting that they would be less likely discussed in some of these comments. intentions to not smoke in the next year, to be smoking 1 year from now. For example, it was rated highly on its with 71.6 percent of youth viewing the We received a number of comments ease of comprehension and induced image reporting that they would not be on this image, which we have relatively greater worry and feelings of likely to smoke in the next year summarized and responded to in the discouragement from wanting to smoke compared to 56.9 percent of youth following paragraphs. than a text-only control in one viewing the text-only control. (Comment 63) FDA received several submitter’s study. As is discussed in further detail in comments supporting the use of the (Response) As discussed in section section III.E of this document, three image ‘‘smoke approaching baby,’’ III.C of this document, we carefully other images proposed for use with this including comments from individuals, a considered the comments submitted to warning statement, ‘‘smoke at toddler,’’ public health advocacy group, and State the docket that described the results of ‘‘girl crying,’’ and ‘‘girl in oxygen and local public health agencies. Some studies conducted by the submitters on mask,’’ also had significant effects on all of these comments indicated that this our proposed required warnings. The the salience measures (emotional image is the best image of the ones results summarized in these comments reaction scale, cognitive reaction scale, proposed for use with this warning are generally supportive of our image and difficult to look at measure) in all statement. One comment stated that the selection decisions. three study populations (adults, young image will clearly inform parents that (Comment 66) FDA also received adults, and youth). While several of the when they smoke in the presence of some comments critical of the image images proposed for use with this their children, their children will also ‘‘smoke approaching baby.’’ These warning statement could effectively be inhaling toxins, and another comments suggested that the child does convey the negative health comment noted that the image not appear to be suffering harms to his consequences of tobacco smoke realistically shows secondhand smoke health and/or looks too healthy. One of exposure for nonsmokers (and in exposure and health effects. Some these comments also stated that the particular, children), we ultimately comments noted that the image will image was associated with youth considered ‘‘smoke approaching baby’’ deter smoking, with one comment reporting that they would be more likely to have the strongest overall research noting that the depiction of an innocent to be smoking 1 year from now, and results of the images proposed for use baby will resonate with parents and advised against its use. with this warning statement for multiple cause them to think about their (Response) We do not agree that the reasons. children’s health before smoking. image does not depict the health First, two of the images that also (Response) We selected this image for hazards of secondhand smoke. Graphic showed significant effects on all the use with this warning statement. depictions of the visible effects of salience measures across the study (Comment 64) FDA also received disease are not the only way of populations, ‘‘girl crying’’ and ‘‘girl in some comments expressing support for communicating the health risks of oxygen mask,’’ were negatively the diversity reflected in the image. One secondhand smoke for children (see Ref. associated with beliefs about the health comment stated that the image will 11), some of which (such as impaired risks of secondhand smoke exposure for appeal to different age and other lung growth), are not necessarily nonsmokers in the adult sample. In demographic groups, while another externally visible in a photograph of a other words, adults who viewed these comment noted that the child in the child exposed to secondhand smoke. images were less likely to believe that image could be African-American, Furthermore, it is important to keep in nonsmokers will suffer from negative Hispanic, Latino, Native American, and/ mind that the image is not used in health effects related to secondhand or Native Hawaiian or Pacific Islander, isolation, but accompanies the textual smoke exposure than adults who and suggested that the image could warning statement, which provides viewed the text-only control. resonate with a variety of important additional context for what is shown. As As described in section III.B of this population subgroups. The comment evidenced by the significant effects the document, we determined that the also noted that Latino parents say the image had on the salience measures salience results from our research study health of their children is a motivating compared to the text-only control across are the most meaningful basis for factor in their decision to quit smoking. the populations participating in FDA’s making distinctions among the images (Response) It is important to have a research study, the required warning given the design limitations of the diverse set of images that communicate depicts the health consequences of

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secondhand smoke exposure in a Several comments noted that, based comments expressed a belief that the manner that has an impact on both on FDA’s research results, this image is image of the diseased lung is ‘‘too gross’’ smokers and potential smokers. Thus, the clear choice among the four images and some expressed a belief that the we conclude that the required warning proposed by FDA for use with this image is too healthy in appearance, the effectively conveys the message that warning statement. Some comments image effectively evoked emotional and exposure to tobacco smoke is harmful noted that similar images have been cognitive reactions in viewers in FDA’s for children. used effectively in other countries that research study, which in turn suggests We also note that the comment stating require graphic health warnings on that the image has the potential to that the image was associated with cigarette packages. One comment noted promote greater awareness of the health youth reporting that they would be more that this image could reach a younger risks of smoking and motivate positive likely to be smoking 1 year from now is audience, and hopefully prevent them behavioral outcomes, including an incorrect. In fact, the image had a from starting to smoke. increased likelihood that smokers will statistically significant effect on (Response) We selected this image for reduce their smoking, make an attempt decreasing youth intentions to smoke use with this warning statement. to quit, or quit altogether (Refs. 20, 44, (see Ref. 49 at p. 4–4; see also Ref. 50). (Comment 68) As mentioned in and 45). As stated previously, 71.6 percent of section III.C of this document, some comments submitted to the docket 4. ‘‘WARNING: Cigarettes Cause youth viewing this image reported that Cancer’’ they would not be likely to smoke in the described the results of scientific next year, compared to 56.9 percent of investigations that the submitters had We selected the image which appears youth viewing the text-only control. conducted to examine the potential on pages 33 and 34 of the document effectiveness of FDA’s proposed images ‘‘Proposed Required Warning Images,’’ 3. ‘‘WARNING: Cigarettes Cause Fatal on various outcomes. This image was referred to as ‘‘cancerous lesion on lip,’’ Lung Disease’’ discussed in some of these comments. for use with this warning statement. In our research study, this image had We selected the image which appears For example, in one submitter’s study, a significant effect (p<0.001) on all the on pages 25 and 26 of the document participants rated this image highly on salience measures (emotional reaction ‘‘Proposed Required Warning Images,’’ its ease of comprehension. It also scale, cognitive reaction scale, and referred to as ‘‘healthy/diseased lungs,’’ induced relatively greater worry and difficult to look at measure) in all three for use with this warning statement. feelings of discouragement from wanting to smoke than a text-only study populations (adults, young adults, In our research study, this image had control. The submitter concluded that and youth). The image had the a significant effect (p<0.001) on all the this image was the most effective of the numerically largest effects of the images salience measures (emotional reaction images proposed for use with this proposed for use with this warning scale, cognitive reaction scale, and warning statement. Another comment statement on the emotional reaction difficult to look at measure) in all three also submitted research suggesting that scale and had the numerically largest study populations (adults, young adults, this image was the highest rated for effects on the cognitive reaction scale in and youth). The image had the potential effectiveness among the set of young adults and youth. As discussed in numerically largest effects of the images images proposed for use with this section III.B of this document, these proposed for use with this warning warning statement. Another submitter salience impacts are important, as the statement on the salience measures. As showed that, in a survey, respondents research literature suggests that they are discussed in section III.B of this rated this image as one of the most related to behavior change. document, these salience impacts are effective of the 36 proposed images for The image also had a significant important, as the research literature encouraging smokers to quit smoking. impact (p<0.05) on beliefs about the suggests that they are likely to be related The image was also identified in a health risks of smoking for smokers, and to behavior change. survey of high school students as one of a significant impact (p<0.01) on beliefs The image also showed some of the the ‘‘top three’’ proposed required about the health risks of secondhand largest effect sizes for image recall (at warnings (out of 36) in another smoke exposure for nonsmokers relative baseline and at 1 week follow-up) in submitter’s study. to the text-only control in the adult adults and youth across the images (Response) As discussed in section sample that viewed a hypothetical proposed for use with this warning III.C of this document, we carefully advertisement containing the proposed statement. considered the comments submitted to required warning. We received a number of comments the docket that described the results of The image also showed some of the on this image, which we have studies conducted by the submitters on largest effect sizes for image recall (at summarized and responded to in the our proposed required warnings. The baseline and 1 week follow-up) in following paragraphs. results summarized in these comments adults and youth across the images (Comment 67) FDA received a large are generally supportive of our image proposed for use with this warning number of comments supporting the use selection decisions. statement, though it showed lower of the image ‘‘healthy/diseased lungs,’’ (Comment 69) FDA also received correct recall of the warning statement including comments from individuals, some comments critical of the image compared to the control in adults at 1 public health advocacy groups, medical ‘‘healthy/diseased lungs.’’ One comment week follow-up (68.3 percent versus organizations, academics, State and noted that the image was ‘‘too gross to 85.1 percent). However, recall of the local public health agencies, and health be effective,’’ while several comments statement was generally high at 1 week care professionals. Many comments expressed the opposite belief, with some follow-up among study participants indicated that this image is the best suggesting that the diseased pair of who viewed this image (ranging from image for use with this warning lungs should be more damaged. 68.3 percent to 77 percent), and, based statement, with one stating that the (Response) The image ‘‘healthy/ on the scientific literature, we conclude image dramatically depicts a health diseased lungs’’ is an appropriate image that repetitive viewing of the required consequence of smoking, and another that effectively conveys the negative warning is likely to increase recall. As noting that it was appropriately gripping health consequences of smoking. While, explained in section III.C of this and compelling. as reflected in the above summary, some document, we gave greater weight to

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outcomes on the salience measures than Multiple comments also noted that, are generally supportive of our image to outcomes on the recall measures. based on FDA’s research results, this selection decisions. As is discussed in further detail in image was the best choice among the (Comment 73) FDA also received section III.E of this document, another four images proposed for use with this some comments critical of the image image proposed for use with this warning statement, significantly ‘‘cancerous lesion on lip.’’ Two warning statement, ‘‘deathly ill outperforming ‘‘white cigarette burning’’ comments indicated that the image was woman,’’ also had significant effects on and ‘‘red cigarette burning,’’ and slightly ‘‘too gross’’ to be effective, while all the salience measures (emotional outperforming ‘‘deathly ill woman.’’ another comment stated that it borders reaction scale, cognitive reaction scale, (Response) We selected this image for on the offensive. In contrast, some and difficult to look at measure) in all use with this warning statement. comments suggested that the image three samples (adults, young adults, and (Comment 71) Several comments should be more graphic. Another youth). While we agree that this image, noted that the image could be especially comment suggested that oral cancer was similar to the selected image of effective with younger audiences and an odd choice of cancers to depict in the ‘‘cancerous lesion on lip,’’ is a very could positively influence such graphic warning. strong image that effectively conveys the audiences by illustrating how the health (Response) We disagree with these negative health consequences of effects caused by smoking negatively comments. With respect to the smoking, we ultimately chose affect their physical appearance. The comments stating that the image was ‘‘cancerous lesion on lip’’ for use with comments indicated that adolescents ‘‘too gross’’ or that it was offensive, the this warning statement for several can relate to and will be susceptible to research literature indicates that images reasons. this message. that evoke strong emotional reactions (Response) We agree with these First, ‘‘cancerous lesion on lip’’ was can promote greater awareness and comments. It is important to include the only image among the images better recollection of the health risks of content in the required warnings that is smoking and can increase the likelihood proposed for use with this warning relevant to youth. The image ‘‘cancerous smokers will reduce their smoking, statement that had a positive impact on lesion on lip’’ has the potential to make an attempt to quit, or quit beliefs about the health risks of smoking positively impact youth behavior, in altogether (Refs. 20, 44, and 45). and secondhand smoke exposure in one addition to adult and young adult With respect to the suggestion that the of the study samples (adults viewing a behavior. image is not graphic enough, as hypothetical advertisement). (Comment 72) As mentioned in discussed previously, this image had a Furthermore, as is stated in several section III.C of this document, some highly significant effect (p<0.001) on all comments (see the following comments submitted to the docket the salience measures (emotional paragraphs), the selected image, described the results of scientific reaction scale, cognitive reaction scale, ‘‘cancerous lesion on lip,’’ is likely to investigations that the submitters had and difficult to look at measure) in all have particular relevance for youth. As conducted to examine the potential three study populations (adults, young explained in some of these comments, effectiveness of FDA’s proposed images adults, and youth), which in turn the research literature suggests that on various outcomes. This image was suggests that the image has the potential youth are likely to relate to and be discussed in some of these comments. to motivate positive behavior change susceptible to cigarette warnings For example, in one submitter’s study, (Id.). depicting the negative short-term participants rated this image highly on Furthermore, the choice of cancers impacts of smoking on their personal its ease of comprehension. It also depicted in the required warning is appearance, including their lips and induced relatively greater worry and appropriate, and will help inform the teeth (Ref. 53). feelings of discouragement from public that cigarettes cause oral cancers, We received a number of comments wanting to smoke than a text-only and thus increase public awareness of on this image, which we have control. The submitter concluded that the negative health consequences of summarized and responded to in the this image, along with ‘‘deathly ill smoking. following paragraphs. woman,’’ was one of the most effective (Comment 70) FDA received a large of the images proposed for use with this 5. ‘‘WARNING: Cigarettes Cause Strokes number of comments supporting the use warning statement. In addition, this and Heart Disease’’ of the image ‘‘cancerous lesion on lip,’’ image was rated as the most effective of We selected the image which appears including comments from individuals, the 36 proposed images in another on pages 39 and 40 of the document public health advocacy groups, a submitter’s survey of comparative ‘‘Proposed Required Warning Images,’’ medical organization, academics, State effectiveness of the images in helping referred to as ‘‘oxygen mask on man’s and local public health agencies, and smokers quit. It was also the highest face,’’ for use with this warning health care professionals. Several rated image among the set of images statement. comments suggested that FDA should proposed by FDA for use with this In our research study, this image had use this image because it has a very high warning statement in another a significant effect (p<0.001) on all the potential to reach consumers and submitter’s study of the potential salience measures (emotional reaction positively influence their behavior. effectiveness of the images, and was scale, cognitive reaction scale, and A few comments also specifically identified by high school students as difficult to look at measure) in all three addressed the benefits of using an image one of the ‘‘top three’’ proposed study populations (adults, young adults, that shows the public that cigarettes required warnings (out of 36) in another and youth). The image had the cause oral cancers, noting that public submitter’s study. numerically largest effects of the images awareness of this negative health (Response) As discussed in section proposed for use with this warning consequence is low, and that many III.C of this document, we carefully statement on the emotional reaction smokers and nonsmokers only relate considered the comments submitted to scale and the difficult to look at measure cigarettes to lung cancer (see also the docket that described the results of in all the study populations. These section II.C of this document regarding studies conducted by the submitters on impacts are important, as the research consumers’ lack of knowledge regarding our proposed required warnings. The literature suggests that graphic warnings the health risks of smoking). results summarized in these comments that evoke responses of this kind are

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likely to increase awareness of the (Response) As discussed in section ‘‘Proposed Required Warning Images,’’ health risks of smoking and increase the III.C of this document, we carefully referred to as ‘‘baby in incubator,’’ for likelihood that smokers will reduce considered the comments submitted to use with this warning statement. their smoking, make an attempt to quit, the docket that described the results of In our research study, this image had or quit altogether (Refs. 20, 44, and 45). studies conducted by the submitters on a significant effect (p<0.001) on all the The image also showed some of the our proposed required warnings. The salience measures (emotional reaction largest effect sizes for image recall (at results summarized in these comments scale, cognitive reaction scale, and baseline and 1 week follow-up) in are generally supportive of our image difficult to look at measure) in all three adults and youth across the images selection decisions. study populations (adults, young adults, proposed for use with this warning (Comment 76) FDA also received and youth). The image had the statement. some comments critical of the image numerically largest effects of the images We received a number of comments ‘‘oxygen mask on man’s face.’’ One proposed for use with this warning on this image, which we have comment noted that the image was ‘‘too statement on the salience measures. As summarized and responded to in the gross to be effective,’’ and one comment discussed in section III.B of this following paragraphs. stated that the image should feature a document, these salience impacts are (Comment 74) FDA received a large younger person to highlight the fact that important, as the research literature number of comments supporting the use heart attacks and stroke can occur in suggests that they are likely to be related of the image ‘‘oxygen mask on man’s young smokers as well as in older to behavior change. face,’’ including comments from smokers. The image had a significant effect individuals, medical organizations, (Response) The image ‘‘oxygen mask (p<0.01) on recall of the warning public health advocacy groups, health on man’s face’’ is an appropriate image statement at baseline compared to the care professionals, State public health that effectively conveys the negative text-only control in youth. The image agencies, and academics. Many of these health consequences of smoking. We do also had a significant effect (p<0.05) on comments indicated that this image is not agree with the statement that the statement recall at follow-up in young the best image for use with this warning image is ‘‘too gross to be effective;’’ the adults, and showed the largest effect statement, while some also noted that image effectively elicited emotional and sizes for image recall (at baseline and 1 the image will make smokers think cognitive reactions in viewers in our week follow-up) in adults and youth twice about continuing to smoke. Some research study, which in turn suggests across the images proposed for use with comments also noted that the image is that the image has the potential to this warning statement. beneficial in that it will inform the promote greater awareness of the health public of negative consequences of risks of smoking and motivate positive The image had a significant impact smoking aside from lung disease. behavioral outcomes, including an (p<0.05) on beliefs about the health Some comments also noted that, increased likelihood that smokers will risks of smoking for smokers in adults, based on FDA’s research results, this reduce their smoking, make an attempt although it had a negative significant image was the best choice for use with to quit, or quit altogether (Refs. 20, 44, impact (p<0.05) on beliefs about the this warning statement, noting that it and 45). health risks of smoking for smokers in elicited the highest scores on the While we agree with the statement in youth. Thus, the results on this beliefs emotional reaction scale of the images the comment that heart disease and measure were mixed for ‘‘baby in tested for use with this statement in strokes can occur in young smokers as incubator.’’ However, given the strength FDA’s research study. well as in older smokers, the selected of the effects observed for this image on (Response) We selected this image for required warning will effectively the salience measures, the required use with this warning statement. communicate with a range of audiences, warning that includes the ‘‘baby in (Comment 75) As described in section including consumers of different ages. incubator’’ image is likely to increase III.C of this document, some comments As described previously, ‘‘oxygen mask awareness of the health risks of smoking submitted to the docket described the on man’s face’’ had a significant effect and increase the likelihood that smokers results of scientific investigations that (p<0.001) on all the salience measures will reduce their smoking, make an the submitters had conducted to (emotion measures, cognition measures, attempt to quit, or quit altogether (Refs. examine the potential effectiveness of and difficult to look at measure) in all 20, 44, and 45). FDA’s proposed images on various three study populations (adults, young We received a number of comments outcomes. This image was discussed in adults, and youth). We considered the on this image, which we have some of these comments. For example, variety and diversity reflected in the summarized and responded to in the in one submitter’s study, participants images in making selection decisions, following paragraphs. rated this image highly on its ease of and took into account the importance of (Comment 77) FDA received a number comprehension. It also induced selecting a set of required warnings that of comments supporting the use of the relatively greater worry and feelings of includes a diversity of styles (e.g., image ‘‘baby in incubator,’’ including discouragement from wanting to smoke photographic versus illustrative), comments from individuals, a than a text-only control. The submitter themes, and human images (e.g., race, community organization, a public concluded that this image was the most gender, age). While the person shown in health advocacy group, health care effective of the images proposed for use this image is an older man, some of the professionals, a State public health with this warning statement. In another images show younger people. Overall, agency, and academics. Several of these submitter’s study, this image was the the nine selected required warnings will comments indicated that this image is highest-rated of the FDA-proposed effectively communicate to a wide range the best image for use with this warning images for use with this warning of consumers, including both young and statement, with some noting that the statement; however, this study also older smokers. image effectively shows how smoking evaluated two images used with similar during pregnancy can damage a baby’s warning statements in other countries 6. ‘‘WARNING: Smoking During health. One comment noted that the (one of open heart surgery, one of a Pregnancy Can Harm Your Baby’’ image could stimulate discussion about bloody brain), and noted that they rated We selected the image which appears how smoking affects pregnancy among higher than FDA’s proposed images. on pages 45 and 46 of the document youth.

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One comment also noted that the One comment stated that the image sizes for image recall among the images image ‘‘baby in incubator’’ bordered on the offensive. proposed for this warning statement at outperformed the other image proposed (Response) The image ‘‘baby in baseline in all study populations and at for use with this warning statement in incubator’’ is an appropriate image that 1 week follow-up in young adults and FDA’s research study on the key criteria effectively conveys the negative health youth. that have proven most meaningful. consequences of smoking. As discussed Young adults viewing the image had (Response) We selected this image for in section III.C of this document, we are significantly lower recall of the warning use with this warning statement. aware that many comments received in statement than those viewing the text- (Comment 78) As described in section the docket expressed concern about the only control at baseline (76.2 percent III.C of this document, some comments use of graphic illustration style images versus 92.3 percent) and 1 week follow- submitted to the docket described the and expressed a belief that this style up (78.9 percent versus 91.3 percent). results of scientific investigations that was not strong enough to elicit However, recall of the statement was the submitters had conducted to appropriate reactions. However, as generally high at baseline and follow-up examine the potential effectiveness of discussed in section III.C of this among study participants who viewed FDA’s proposed images on various document, we disagree with the this image (ranging from 76.2 percent to outcomes. This image was discussed in contention that the use of graphic 90.4 percent), and repetitive viewing of some of these comments. For example, illustration style images is categorically the required warning is likely to in one submitter’s study, participants inappropriate. As the results from our increase recall. As explained in section rated this image highly on its ease of research study demonstrate, the ‘‘baby III.C of this document, we gave greater comprehension. It also induced in incubator’’ image effectively elicited weight to outcomes on the salience relatively greater worry and feelings of emotional and cognitive reactions, measures than to outcomes on the recall discouragement from wanting to smoke showing a highly significant effect measures. than a text-only control. The submitter (p<0.001) on these measures in all study We received a number of comments on this image, which we have concluded that this image was the most populations, which in turn suggests that summarized and responded to in the effective of the images proposed for use the image has the potential to promote greater awareness of the health risks of following paragraphs. with this warning statement. However, (Comment 80) FDA received a large in another submitter’s study, this image smoking and motivate positive behavioral outcomes, including an number of comments supporting the use was evaluated against images used in of the image ‘‘man with chest staples,’’ other countries, one of which was very increased likelihood that smokers will reduce their smoking, make an attempt including comments from individuals similar in composition to ‘‘baby in (including former smokers), public incubator’’ but which was a photograph to quit, or quit altogether (Refs. 20, 44, and 45). health advocacy groups, medical rather than a graphic illustration. In that organizations, health care professionals, submitter’s study, the photographic In addition, based on the study results, we also do not agree that the State and local public health agencies, image was rated significantly higher and academics. Many of these than ‘‘baby in incubator.’’ image is inappropriately offensive or that our research results for this image comments indicated that this image is (Response) As discussed in section are not compelling. Based on the overall the best image for use with this warning III.C of this document, we carefully feedback received, we also disagree that statement, while some also noted that considered the comments submitted to the text in the proposed warning is the image is appropriately attention- the docket that described the results of difficult to read. grabbing or powerful and that it will studies conducted by the submitters on make smokers think twice about our proposed required warnings. The 7. ‘‘WARNING: Smoking Can Kill you’’ continuing to smoke, or help them results summarized in these comments We selected the image which appears smoke less. Some comments also noted are generally supportive of our image on pages 49 and 50 of the document that the image is an excellent way of selection decisions. ‘‘Proposed Required Warning Images,’’ driving home the message that smoking (Comment 79) FDA also received a referred to as ‘‘man with chest staples,’’ can kill you. One comment stated that number of comments critical of the for use with this warning statement. the image is a strong, solid concept that image ‘‘baby in incubator.’’ The majority In our research study, this image had has been used effectively in other of these comments objected to the a significant effect (p<0.001) on all the countries that require graphic health graphic illustration style used for the salience measures (emotional reaction warnings on cigarette packages. image, with some submitters approving scale, cognitive reaction scale, and Some comments stated that, based on of the concept but stating that a difficult to look at measure) in all three FDA’s research results, this image is the photograph would be more impactful, study populations (adults, young adults, best choice for use with this warning and some indicating that the style is and youth). The image had the statement, noting that it elicited the inappropriate, either because it numerically largest effects of the images highest scores on the emotional reaction downplays the seriousness of the risk proposed for use with this warning scale of the images tested for use with described in the required warning or statement on the salience measures. As this statement in FDA’s research study, because it would inappropriately appeal discussed in section III.B of this and had other positive results. to youth without discouraging them document, these salience impacts are (Response) We selected this image for from smoking. important, as the research literature use with this warning statement. Some comments indicated that the suggests that they are likely to be related (Comment 81) As described in section lettering style used in the image was to behavior change. III.C of this document, some comments difficult to read, and one comment The image was also associated with submitted to the docket described the stated that the results from FDA’s higher intentions to quit smoking results of scientific investigations that research study for this image, while compared to the text-only control the submitters had conducted to better than the results for the other (p<0.05) in adults. examine the potential effectiveness of image proposed for use with this The proposed required warning FDA’s proposed images on various warning statement (‘‘pacifier & featuring the ‘‘man with chest staples’’ outcomes. This image was discussed in ashtray’’), were not compelling. image showed some of the largest effect some of these comments. For example,

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in one submitter’s study, participants desirable ways. The figure shown is the best image of the ones proposed for rated this image highly on its ease of appropriate; although some of the use with this warning statement. One comprehension. It also induced negative health consequences of comment stated that the image stood out relatively greater worry and feelings of smoking may lead to the effects on as particularly effective among the discouragement from wanting to smoke appearance suggested in the comments proposed required warnings because it than a text-only control. In another (e.g., significant disease-related weight shows the devastating effects submitter’s study, it was noted that, loss), other consequences, such as heart secondhand smoke can have on people based on respondents’ rating and attacks, can kill smokers without first who have tried to protect themselves by ranking of this image’s effectiveness, the causing these effects. not smoking, and indicated that the image clearly stands out as the highest 8. ‘‘WARNING: Tobacco Smoke Causes image will remind smokers that they are rated of the images FDA proposed for Fatal Lung Disease in Nonsmokers’’ harming their loved ones and others use with this warning statement. around them as well as themselves. (Response) As discussed in section We selected the image which appears Others noted that the image sends a III.C of this document, we carefully on pages 57 and 58 of the document powerful message. considered the comments submitted to ‘‘Proposed Required Warning Images,’’ One comment indicated that the the docket that described the results of referred to as ‘‘woman crying,’’ for use image outperformed the other images studies conducted by the submitters on with this warning statement. proposed for use with this warning our proposed required warnings. The In our research study, this image had statement on the emotional reaction results summarized in these comments a significant effect (p<0.001) on the scale and the difficult to look at measure emotional reaction scale in all three are generally supportive of our image in FDA’s research, and noted that it study populations (adults, young adults, selection decisions. appears to be a cut above the other and youth). It also showed significant (Comment 82) FDA also received images. effects on the difficult to look at some comments critical of the image (Response) We selected this image for measure in all study populations (adults ‘‘man with chest staples.’’ One comment use with this warning statement. stated that the image was ‘‘too gross to (p<0.01), young adults (p<0.001), and (Comment 84) One comment be effective,’’ while another stated the youth (p<0.001)), and significant effects approved of the diversity reflected in image ‘‘offend[s] against human on the cognitive reaction scale in all the image (which shows an African- dignity.’’ A few comments suggested study populations (adults (p<0.05), American woman). that the person in the image should look young adults (p<0.001), and youth (Response) We agree that it is worse (e.g., paler, weaker, thinner, like (p<0.001)). This image was the only beneficial to have a diverse set of images he had suffered more), and some image proposed for use with this comments suggested the person’s death warning statement that showed that communicate with a wide range of should be more clearly tied to smoking significant effects on all the salience audiences, including a variety of by the image. One comment indicated measures in our research study. population subgroups. In order to that persons unfamiliar with an autopsy The image also had a significant ensure that the final set of required may not understand the image. impact (p<0.05) on beliefs about the warnings effectively communicates risk (Response) The image ‘‘man with health risks of smoking for smokers in information to a diverse range of chest staples’’ is an appropriate image young adults. audiences, we selected a set of nine that effectively conveys the negative The proposed required warning that required warnings, including the image health consequences of smoking. We do included this image also showed the ‘‘woman crying,’’ that includes a variety not agree that the image ‘‘is too gross to largest effect sizes for image recall (at of human images that are broadly be effective’’ or that it ‘‘offend[s] against baseline and 1 week follow-up) in representative of the overall population. human dignity;’’ the image shows a adults, young adults, and youth across (Comment 85) As described in section realistic outcome of the negative health the images proposed for this warning III.C of this document, some comments consequences caused by smoking, and statement. Youth viewing the image had submitted to the docket described the effectively elicited emotional and significantly lower recall of the warning results of scientific investigations that cognitive reactions in viewers in our statement than those viewing the text- the submitters had conducted to research study. This in turn suggests only control at baseline (52.4 percent examine the potential effectiveness of that the image has the potential to versus 68.9 percent). However, recall of FDA’s proposed images on various promote greater awareness of the health the statement was generally high among outcomes. This image was discussed in risks of smoking and motivate positive study participants who viewed this some of these comments. For example, behavioral outcomes, including an image, and repetitive viewing of the this image induced relatively greater increased likelihood that smokers will required warning is likely to increase worry and led to higher ratings of reduce their smoking, make an attempt recall. As explained in section III.C of feeling discouraged from wanting to to quit, or quit altogether (Refs. 20, 44, this document, we gave greater weight smoke than a text-only control in one and 45). to outcomes on the salience measures submitter’s study. Viewers will understand that the than to outcomes on the recall (Response) As discussed in section image shows someone who has died measures. III.C of this document, we carefully from a smoking-related cause. Although FDA received a number of comments considered the comments submitted to we agree that not all viewers will on this image, which the Agency has the docket that described the results of necessarily be familiar with an autopsy summarized and responded to in the studies conducted by the submitters on scar, it is important to keep in mind that following paragraphs. our proposed required warnings. The the image is not used in isolation, but (Comment 83) FDA received several results summarized in these comments accompanies the textual warning comments supporting the use of the are generally supportive of our image statement, which provides additional image ‘‘woman crying,’’ including selection decisions. context for what is shown. The results comments from individuals (including (Comment 86) FDA also received observed in our research study suggest former smokers) and public health some comments critical of the image that viewers from all age groups advocacy groups. Some of these ‘‘woman crying.’’ One comment understood and reacted to this image in comments indicated that this image is indicated that the image borders on the

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offensive, while another stated it is too In our research study, the image had received in the docket, which is sensational to be effective. a statistically significant effect on the discussed in the comment summaries in Other comments suggested that the emotional reaction scale in young adults the following paragraphs and in section image did not directly portray a health (p<0.05), and on the cognitive reaction III.E of this document. consequence of secondhand smoke, or scale in adults (p<0.05), young adults Furthermore, as noted in section III.A that the image is not clearly tied to (p<0.01), and youth (p<0.001). of this document, in order to ensure that secondhand smoke. One comment also The proposed required warning that the final set of required warnings suggested that the image should not be included this image also showed the effectively communicates risk used because it did not have an impact largest effect sizes for image recall (at information to a diverse range of on beliefs about the health harms of baseline and 1 week follow-up) in audiences, we selected a set of nine secondhand smoke or on quit intentions adults, young adults, and youth across required warnings, including the image in FDA’s research study. the images proposed for this warning ‘‘man I Quit t-shirt,’’ that includes a (Response) We disagree with these statement. variety of human images that are comments. The image ‘‘woman crying’’ Although this image, along with the broadly representative of the overall is an appropriate image that effectively other images proposed for use with this population. The image ‘‘man I Quit t- warning statement, did not elicit the conveys the negative health shirt’’ contributes to the variety seen in magnitude of reactions on the salience consequences of smoking. We do not the final set of images by picturing a measures (emotional reaction scale, agree that the image is offensive or too man who is younger than the men in the cognitive reaction scale, difficult to look sensational; the image is a realistic other required warning images. at measure) that some of the images portrayal of how the negative health Additionally, as reflected in the proposed for use with other warning consequences caused by exposure to comment summary, the man shown in statements did, this is likely a result of secondhand smoke can affect people. It the image is perceived by many viewers the information being conveyed in the as strong and ‘‘macho,’’ suggesting that effectively elicited emotional and warning statement, which emphasizes the image has the potential to reach and cognitive reactions in those who viewed the positive health benefits of quitting effectively communicate with a it in our research study, which in turn smoking. The content of this required demographic group that has been suggests that the image has the potential warning is not expected to arouse the heavily targeted by tobacco industry to promote greater awareness of the same level of response on some of the cigarette advertising (see Ref. 54 at p. health risks of smoking and motivate salience measures as the other messages. 151). The depiction of men as strong, positive behavioral outcomes, including However, the research literature powerful, macho, rugged, and an increased likelihood that smokers suggests that warnings that focus on the independent, and the association of will reduce their smoking, make an benefits of quitting are effective at these characteristics with cigarette attempt to quit, or quit altogether (Refs. encouraging cessation, and suggests that brands, has long been a prominent 20, 44, and 45). positive, self-efficacy messages can be theme in tobacco industry advertising We do not agree that the image does used effectively as one component of (Id. at p. 151), and targeted marketing not depict a health consequence of graphic health warnings to increase efforts by the tobacco industry have led secondhand smoke. Graphic depictions smokers’ motivations and confidence to greater smoking uptake and lower of the visible effects of disease are not about quitting (Ref. 40 at pp. 35, 39–41). cessation rates in targeted subgroups (Id. the only way of communicating the The research literature also highlights at p. 211). health risks of secondhand smoke the importance of including one or more We received a number of comments exposure (see Ref. 11). The negative warnings that provide solutions, such as on this image, which we have health consequences caused by the ‘‘man I Quit t-shirt’’ required summarized and responded to in the secondhand smoke exposure, including warning, in a set of warnings conveying following paragraphs. fatal lung disease, have many the negative health consequences of (Comment 87) FDA received a number dimensions, including emotional smoking. Specifically, the literature of comments supporting the use of the suffering. This image highlights that recommends that, in addition to image ‘‘man I Quit t-shirt,’’ including dimension. Furthermore, it is important communicating the health risks of comments from individuals, public to keep in mind that the image is not smoking, some warnings should also health advocacy groups, medical used in isolation, but accompanies the provide information on how to avoid organizations, and State and local textual warning statement, which these risks (i.e., by quitting), in order to public health agencies. Many of these provides additional context for what is optimize the effectiveness of the overall comments indicated that this image is shown. As evidenced by the image’s set of warning messages (see Ref. 48 and the best image of the ones proposed for significant impact on the salience Ref. 40 at p. 37). use with this warning statement. Several measures across the populations As is discussed in further detail in of the comments discussed specific participating in our research study, the section III.E of this document, another favorable aspects of the image or proposed required warning effectively image proposed for use with this potential effects of the image, including depicts the health consequences of warning statement, ‘‘cigarettes in toilet that the image models a positive secondhand smoke exposure, including bowl,’’ also had significant effects on behavior, is compelling, and that it will the suffering endured by those the emotional reaction scale in some encourage others to quit. Several experiencing these health consequences. study populations and on the cognitive comments believed that the image could reaction scale, as well as showing reach a critical demographic group by 9. ‘‘WARNING: Quitting Smoking Now positive effects on other study measures. showing a younger, ‘‘cool,’’ ‘‘macho’’ Greatly Reduces Serious Risks to Your While this image, similar to the selected man and suggesting that it is manly and/ Health’’ image (‘‘man I Quit t-shirt’’), could be or cool to quit smoking. Some We selected the image which appears effectively used with this warning comments also suggested that the image on pages 67 and 68 of the document statement, we ultimately selected ‘‘man is positive in that it shows that quitting ‘‘Proposed Required Warning Images,’’ I Quit t-shirt’’ for use with this warning is a heroic decision. referred to as ‘‘man I Quit t-shirt,’’ for statement based on a consideration of (Response) We selected this image for use with this warning statement. multiple factors, including the feedback use with this warning statement.

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(Comment 88) As described in section positive manner, discussing the health Versions of both of these images have III.C of this document, some comments benefits of ceasing to smoke, and the been used in other contexts. For submitted to the docket described the image is consistent with this text. This example, the image of an exclamation results of scientific investigations that required warning, particularly as part of mark enclosed within a triangle is often the submitters had conducted to the overall set of required warnings, will used to draw attention to a warning of examine the potential effectiveness of help educate consumers about the danger or hazards that could result in FDA’s proposed images on various negative health consequences of personal injury or a threat to health (see, outcomes. This image was discussed in smoking and help encourage positive e.g., 16 CFR 1211.15, 16 CFR 1407.3; 16 some of these comments. In one behavior (see Ref. 40 at pp. 35 and 40). CFR 1500.19; and Ref. 56). The image of submitter’s study, the image ‘‘man I Based on the overall feedback a burning cigarette enclosed in a red Quit T-shirt’’ was the highest rated of received and the results from our circle with a red bar across it is the the images proposed by FDA for use research study, we also disagree that the international ‘‘No Smoking’’ symbol with this warning statement among text in the proposed warning is difficult (Ref. 56) and is often used on signs and adults. This study also tested a version to read or that the image is banal. placards to denote an area where of the required warning that had been smoking is prohibited (see, e.g., 14 CFR manipulated to add a quitline number; 10. Image for Advertisements With a 23.853, 49 CFR 374.201). this version was rated and ranked as the Small Surface Area In light of the other contexts in which most effective warning overall among In addition to proposing 36 required the two proposed images are used, we study participants. In another warnings for use on cigarette packages selected the image of the exclamation submitter’s study, this image was rated and in cigarette advertisements in the mark enclosed within a red equilateral highly on its ease of comprehension, but NPRM, we also proposed two other triangle, as we believe this image is led to lower worry relative to a text-only color graphics for use solely in more appropriate than the other control (but as the researcher noted, the advertisements with a small surface area proposed image for use in the required message in this warning is reassuring: of less than 12 square inches (75 FR warnings. As stated, this image is ‘‘Quitting smoking now greatly reduces 69524 at 69539). As we explained in the commonly used to draw attention to a serious risks to your health’’). NPRM, these two proposed color warning of danger which could result in (Response) As discussed in section graphics differ in their composition personal injury or a threat to health, III.C of this document, we carefully from the other proposed images in that which is consistent with its purpose in considered the comments submitted to the details of these two color graphics cigarette advertisements with a small the docket that described the results of should be clear, conspicuous, and surface area. Many consumers have studies conducted by the submitters on legible even when the image is reduced likely been exposed to similar symbols our proposed required warnings. The in size to occupy 20 percent of a surface in other contexts and, as a result, are results summarized in these comments with an area of less than 12 square likely to recognize and understand that are generally supportive of our image inches (75 FR 69524 at 69535). We the image is drawing attention to a selection decisions. proposed that whichever of these warning of a threat to health. (Comment 89) FDA also received some comments critical of the image options was selected would be used in E. Non-Selected Images ‘‘man I Quit t-shirt.’’ Some comments combination with one of the nine This section discusses the 27 color indicated that the image does not textual statements only in graphic images that we proposed but convey a health consequence of advertisements with a small surface area have not selected for use at this time, smoking, while one indicated that the (i.e., less than 12 square inches). and the factors that influenced the text was difficult to read. One comment However, as we noted in the NPRM, decision not to use each image, also noted that the image failed to show even an advertisement with a relatively including the research results for the an effect on some measures in FDA’s small surface area would need to be images, the comments received in the research study, and another indicated large enough so that the required docket, and the relevant scientific that the image is banal. graphic and accompanying textual literature. (Response) We disagree with these warning statement are clear, Consistent with the discussion of comments. The image ‘‘man I Quit t- conspicuous, and legible (75 FR 69524 selected images in section III.D of this shirt’’ is an appropriate image. at 69539). document, the images are referred to in Consumers can be educated about the We selected the image which appears this section by the pages on which they negative health consequences of on page 75 of the document entitled appear in the ‘‘Proposed Required smoking in a variety of ways. While the ‘‘Proposed Required Warning Images’’ Warning Images’’ document and by the other required warnings discuss and for use with the textual warning descriptive names used in the study portray the consequences of starting or statements solely in advertisements report (Ref. 49, study report) continuing to smoke (which has been with a small surface area (defined as summarizing the results of FDA’s shown to be one effective way to less than 12 square inches). This image research study. educate consumers), another method of depicts a black exclamation mark increasing awareness and knowledge enclosed within a red equilateral 1. ‘‘WARNING: Cigarettes Are about the negative consequences of a triangle. Addictive’’ behavior is to disseminate messages that As stated previously, FDA proposed As discussed in section III.D of this discuss the positive health benefits of two images for use solely with the document, we selected the image ‘‘hole refraining from a behavior (Ref. 55). textual warning statements in in throat’’ for use with the statement, Studies attest to the potential advertisements with a small surface ‘‘WARNING: Cigarettes are addictive.’’ effectiveness of warnings that adopt area; the selected image described in the We proposed three other images for use such an approach (Ref. 40 at p. 35). previous paragraph and an image of a with this statement: ‘‘cigarette Accordingly, the warning statement burning cigarette enclosed in a red injection,’’ which appears on pages 3 used in this required warning, ‘‘Quitting circle with a red bar across it. We did and 4 of the document ‘‘Proposed smoking now greatly reduces serious not receive any comments on either of Required Warning Images;’’ ‘‘red risks to your health,’’ is framed in a the proposed images. puppet,’’ which appears on pages 5 and

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6 of the document ‘‘Proposed Required that, although cigarettes are legal FDA received a number of comments Warning Images;’’ and ‘‘woman in rain,’’ products, they are just as addictive as on this image, which the Agency has which appears on pages 7 and 8 of the illegal drugs like heroin. One comment summarized and responded to in the document ‘‘Proposed Required Warning indicated that the image would be following paragraphs. Images.’’ particularly effective with underage (Comment 91) FDA received several Cigarette Injection. The image smokers. comments that supported the use of the ‘‘cigarette injection’’ had strong overall FDA also received several comments image ‘‘red puppet,’’ including research results in FDA’s research that opposed the use of the image comments from individuals, a public study, including significant effects on ‘‘cigarette injection.’’ Many of these health advocacy group, and from State the emotional and cognitive reaction comments objected to the graphic and local public health agencies. Some scales in all three study populations and illustration style used in the image, with of the comments stated that the image significant effects on the difficult to look some stating it would be ineffective or is likely to be effective, and one stated at measure in adults and young adults. less effective than a photographic image, that it would impact underage smokers. It also showed higher correct recall of and some indicating it would detract Another noted that it was a clever the warning statement compared to the from the seriousness of the message image. control in adults and young adults at being conveyed. Some comments also FDA also received several comments baseline, and was associated with expressed concern that the style would that opposed the use of the image ‘‘red higher intentions to quit compared to inappropriately appeal to youth without puppet.’’ Some of these comments the control for young adults. The image deterring them from smoking. stated that the image style was less also had a positive significant impact on A few comments also objected to the effective than a photographic image. adult beliefs about the health risks of comparison of legal cigarette products One comment expressed concern that smoking for smokers in adults viewing with illegal drugs, with one comment the style would inappropriately appeal the hypothetical cigarette package with indicating this downplayed the to youth without deterring them from the proposed required warning, seriousness of intravenous drug use, and smoking. another comment noting that the although it had a negative significant Several comments expressed concern analogy of cigarette use to heroin use impact on this same measure in adults that the image would not be understood could cause consumers to discount the viewing the hypothetical cigarette by some consumers, including youth message if they believe that cigarette advertisement featuring this proposed and some racial and ethnic minorities, and heroin use are not comparable. required warning. who might not understand and identify The image selected for use with this Some comments also stated that the with the picture of a marionette, or draw warning statement, ‘‘hole in throat,’’ had image could be misunderstood or was the analogy between the manipulation numerically larger effects than this too abstract, and one comment stated suggested by the image of the puppet image (‘‘cigarette injection’’) on the that the image does not illustrate and addiction. salience measures (emotional and adverse health effects. cognitive reaction scales, difficult to One comment noted that the proposed A few comments stated the image look at measure) in all three study required warning featuring the does not convey a health consequence populations. As discussed in section ‘‘cigarette injection’’ image was not of smoking, while one comment stated III.B of this document, the research rated highly on its ease of that the results from FDA’s research literature suggests that the salience comprehension in a research study the study for this image did not support its measures used in FDA’s study are likely submitter conducted on the 36 proposed selection from among the images to be related to behavior change. required warnings, though it did show proposed for use with this warning In addition, the selected image, ‘‘hole a significant effect on worry and feeling statement. in throat,’’ enhanced the diversity of the discouraged from wanting to smoke Three comments noted that the overall set of selected images by helping relative to a text-only control. proposed required warning featuring the ensure the human images broadly (Response) We are not selecting this ‘‘red puppet’’ image was not highly represent the U.S. population. Although image for use in a required warning and rated in research studies conducted by ‘‘cigarette injection’’ offered variety in instead have selected the image ‘‘hole in the submitters. One comment noted that terms of style in that it uses a graphic throat’’ for the reasons given in section the image did not increase worry illustration style as opposed to the III.D of this document. relative to a text-only label or photographic style used in most of the Red puppet. In FDA’s research study, discourage respondents from smoking selected images, this style is the image ‘‘red puppet’’ had significant relative to a text-only label in the incorporated in the final set of required effects on the emotional and cognitive submitter’s study, while two others warnings with the image used for the reaction scales in all three study noted that the image was ranked as one warning statement ‘‘Smoking during populations. It also showed higher of the least effective of the proposed pregnancy can harm your baby.’’ correct recall of the warning statement images by respondents in the FDA received a number of comments compared to the control in young adults submitters’ studies. on this image, which the Agency has at 1 week follow-up. (Response) We are not selecting this summarized and responded to in the However, the selected image, ‘‘hole in image for use in a required warning and following paragraphs. throat,’’ had numerically larger effects instead have selected the image ‘‘hole in (Comment 90) FDA received several than this image on the salience throat’’ for the reasons given in section comments that supported the use of the measures (emotional reaction scale, III.D of this document. image ‘‘cigarette injection,’’ including cognitive reaction scale, difficult to look Woman in rain. In FDA’s research comments from individuals, public at measure) in all three study study, the image ‘‘woman in rain’’ had health advocacy groups, and a State populations. In addition, looking across a significant effect on the difficult to public health agency. Some of the the different measures used in the look at measure in adults and young comments stated that the image would research study, both the image ‘‘hole in adults. The image also had a significant be an effective smoking deterrent. throat’’ and the image ‘‘cigarette impact on adult beliefs about the health Several of the comments noted that the injection’’ had stronger overall research risks of smoking for smokers compared image would help smokers understand results than this image. to the control.

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Looking across the different measures ‘‘smoke approaching baby’’ for use with FDA also received several comments used in FDA’s research study, this the statement, ‘‘WARNING: Tobacco that opposed use of the image ‘‘smoke image was relatively less effective than Smoke Can Harm Your Children.’’ FDA at toddler.’’ Multiple comments stated other images proposed for this warning proposed five other images for use with that the image would be perceived as statement, including the image selected this statement: ‘‘Smoke at toddler,’’ demeaning to smokers by suggesting for use in the required warnings ‘‘hole which appears on pages 11 and 12 of the they blow smoke directly at their in throat.’’ document ‘‘Proposed Required Warning children, and one comment cited the FDA received a number of comments Images;’’ ‘‘smoke at baby,’’ which image as an unreal portrayal. Another on this image, which the Agency has appears on pages 13 and 14 of the comment expressed concern that the summarized and responded to in the document ‘‘Proposed Required Warning image would prompt denial among following paragraphs. Images;’’ ‘‘girl crying,’’ which appears smokers, who would interpret the image (Comment 92) FDA received multiple on pages 15 and 16 of the document to mean that their children are not at comments that supported the use of the ‘‘Proposed Required Warning Images;’’ risk if they do not blow smoke directly image ‘‘woman in rain,’’ including ‘‘warning in child lettering,’’ which at them. One comment said the image comments from individuals, a appears on pages 17 and 18 of the does not depict a negative health community organization, and a State document ‘‘Proposed Required Warning consequence of smoking, while another public health agency. Some of the Images;’’ and ‘‘girl in oxygen mask,’’ comment stated the image was too comments stated that the image is likely which appears on pages 19 and 20 of the positive, in that the child looked too to be effective, and one stated that document ‘‘Proposed Required Warning happy. Finally, another comment stated smokers would be able to relate to the Images.’’ that other images tested in FDA’s image. Smoke at toddler. In FDA’s research research study for use with this warning FDA also received a number of study, the image ‘‘smoke at toddler’’ had statement elicited higher scores on the comments that opposed the use of the significant effects on all the salience emotional and cognitive reaction scales image ‘‘woman in rain.’’ Some of these measures (emotional reaction scale, than this image. comments stated that the image would cognitive reaction scale, difficult to look (Response) We are not selecting this not be effective and is not emotionally at measure) in all three study image for use in a required warning and arousing, while some stated that it populations (adults, young adults, and instead have selected the image ‘‘smoke shows a very weak harm (i.e., standing youth). approaching baby’’ for the reasons given in the rain). Another comment stated However, as discussed in section III.D in section III.D of this document. Smoke at baby. In FDA’s research that the image makes smoking seem like of this document, the selected image, study, the image ‘‘smoke at baby’’ had a normal behavior. ‘‘smoke approaching baby,’’ also had significant effects on the emotional and Several comments expressed concern significant impacts on all the salience that the image would not be understood cognitive reaction scales in all three measures in all three study populations, study populations (adults, young adults, by consumers, indicating it was too and also showed significant impacts on vague in nature and requires a high and youth) and significant effects on the recall and behavioral intentions in some difficult to look at measure in adults analytical ability to understand. populations. Several comments stated the image and youth. It also showed higher correct does not convey a health consequence FDA received a number of comments recall of the warning statement of smoking, while three comments on this image, which the Agency has compared to the control in adults and stated that the results from FDA’s summarized and responded to in the young adults at 1 week follow-up. research study for this image did not following paragraphs. However, as discussed in section III.D support its selection from among the (Comment 93) FDA received a number of this document, the selected image, images proposed for use with this of comments that supported the use of ‘‘smoke approaching baby,’’ had warning statement. the image ‘‘smoke at toddler,’’ including significant impacts on all the salience Two comments noted that the comments from individuals, a medical measures in all three study populations, proposed required warning featuring the organization, public health advocacy and also showed significant impacts on ‘‘woman in rain’’ image was not highly groups, academics, and State and local recall and behavioral intentions in some rated in research studies conducted by public health agencies. Some of these populations. the submitters. One comment noted that comments indicated that the image FDA received a number of comments the image was not rated highly on its would cause people to reconsider on this image, which the Agency has ease of comprehension and did not smoking due to the harm it can cause to summarized and responded to in the increase worry relative to a text-only others, especially a child or a baby. following paragraphs. label or discourage respondents from Three comments noted that the image (Comment 94) FDA received several smoking relative to a text-only label in showed positive impacts in research comments that supported the use of the the submitter’s study, while another studies conducted by the submitters. image ‘‘smoke at baby,’’ including noted that the image was ranked as one Specifically, in one submitter’s study comments from individuals, a of the least effective of the 36 proposed this image had the relatively greatest community organization, a medical images by respondents in the impact in discouraging respondents organization, academics, and a State submitter’s study. from wanting to smoke of the images public health agency. Some of these (Response) We did not select this proposed for use with this warning comments indicated that the image image for use in a required warning and statement. In another submitter’s study would cause people to reconsider instead have selected the image ‘‘hole in of the potential effectiveness of the smoking due to the harm it can cause to throat’’ for the reasons given in section images, this image received the highest children, and one comment noted that III.D of this document. overall rating of the images proposed for the image evokes a strong emotional use with this warning statement. In reaction, clearly communicating that it 2. ‘‘WARNING: Tobacco Smoke Can addition, it was one of the two highest is wrong to engage in the behavior Harm Your Children’’ rated images of the FDA images portrayed in the image. As discussed in section III.D of this proposed for use with this warning Two comments noted that the image document, we selected the image statement in another submitter’s study. showed positive impacts in research

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studies conducted by the submitters. adults. Youth who viewed the image approaching baby’’ for the reasons given Specifically, this image had a significant also reported that they would be in section III.D of this document. impact in discouraging respondents significantly less likely to be smoking 1 Warning in child lettering. In FDA’s from wanting to smoke in one year from now compared to youth who research study, the image ‘‘warning in submitter’s study, and it was one of the viewed the control. child lettering’’ had significant effects two highest-rated images of the FDA However, the image had a significant on the emotional and cognitive reaction images proposed for use with this negative impact on adult beliefs about scales in all three study populations warning statement in another the health risks of secondhand smoke (adults, young adults, and youth). It also submitter’s study. exposure for nonsmokers, i.e., adults showed higher correct recall of the FDA also received several comments who viewed the image were less likely warning statement compared to the that opposed the use of the image to believe that nonsmokers will suffer control in adults and young adults at ‘‘smoke at baby.’’ Many of these from negative health effects due to baseline, and higher correct recall of the comments objected to the graphic secondhand smoke exposure than adults warning statement at 1 week follow-up illustration style used in the image, with who viewed the text-only control. compared to the control for adults, some stating it would be ineffective or As discussed in section III.D of this young adults, and youth. However, less effective than a photographic image, document, the selected image, ‘‘smoke ‘‘warning in child lettering’’ showed and some indicating it would detract approaching baby,’’ had significant lower correct recall of the image at from the seriousness of the message impacts on all the salience measures in baseline and follow-up for adults, young being conveyed. Some comments also all three study populations, and also adults, and youth compared to the other expressed concern that the style would showed significant impacts on recall images. inappropriately appeal to youth without and behavioral intentions in some Looking across the different measures deterring them from smoking. populations. Thus, while ‘‘girl crying’’ used in FDA’s research study, this Multiple comments stated that the showed positive effects on several image was relatively less effective than other images proposed for use with this image would be perceived as demeaning important measures in FDA’s research to smokers by suggesting they blow warning statement, including the image study, the selected image was smoke directly at their children, and selected for use in the required considered to be a stronger choice, as it one comment cited the image as an warnings, ‘‘smoke approaching baby.’’ also showed positive effects on several unreal portrayal. Another comment FDA received a number of comments important measures and did not show expressed concern that the image would on this image, which the Agency has any negative effects. prompt denial among smokers, who summarized and responded to in the FDA received a number of comments would interpret the image to mean that following paragraphs. their children are not at risk if they do on this image, which the Agency has (Comment 96) FDA received several not blow smoke directly at them. summarized and responded to in the comments that supported the use of the A couple of comments stated that following paragraphs. image ‘‘warning in child lettering,’’ other images tested in FDA’s research (Comment 95) FDA received several including comments from individuals, a study for use with this warning comments that supported the use of the public health advocacy group, a medical statement outperformed this image, with image ‘‘girl crying,’’ including organization, and a State public health one noting that other images elicited comments from individuals and from a agency. Some comments felt the use of higher scores on the emotional reaction State public health agency. Some child’s handwriting in the image would scale and difficult to look at measure comments noted that the submitter be especially impactful with parents, than this image, and another noting that found this image to be the most effective and one comment noted that this image other images had higher scores on the of the images proposed for use with this would have wide appeal, resonating quit intentions and recall measures than warning statement, and others noted it with parents of any race or ethnicity. this image. would appropriately elicit negative FDA also received several comments One comment expressed concern that emotions in viewers. that opposed use of the image ‘‘warning the image could be perceived to mean FDA also received several comments in child lettering.’’ Multiple comments that mothers who smoke should not that opposed use of the image ‘‘girl objected to the image style, indicating breastfeed their children. Another crying.’’ Multiple comments stated that that a photographic depiction would be comment stated that the text used in the it was not clear why the girl was crying, more effective at deterring people from proposed required warning was difficult and one comment stated that the image smoking, with one comment noting that to read. does not depict a health consequence of the image style would be (Response) We are not selecting this secondhand smoke exposure. One inappropriately appealing to youth image for use in a required warning and comment indicated that the image was without discouraging them from instead have selected the image ‘‘smoke too sensational to be effective, and smoking. One comment indicated that approaching baby’’ for the reasons given another comment cited the image as an the image does not depict a negative in section III.D of this document. unreal portrayal, stating that young health consequence of smoking, and Girl crying. In FDA’s research study, children do not know they are being another indicated that the image was the image ‘‘girl crying’’ had significant harmed when they are exposed to not eye-catching. effects on all the salience measures smoke and thus would not cry as a Two comments noted that other (emotional reaction scale, cognitive result of such exposure, and noted that images proposed for use with this reaction scale, and difficult to look at this is what makes secondhand smoke warning statement had superior overall measure) in all three study populations exposure so insidious. One comment results compared to this image in FDA’s (adults, young adults, and youth). It also indicated that other images tested in research study and stated that FDA showed higher correct recall of the FDA’s research study for use with this should not select this image for use in warning statement compared to the warning statement had superior overall the required warning. In addition, two control in adults at baseline, and higher results to this image. comments noted that the image was not correct recall of the warning statement (Response) We are not selecting this highly rated in research studies at 1 week follow-up compared to the image for use in a required warning and conducted by the submitters. One text-only control for adults and young instead have selected the image ‘‘smoke comment noted that the image was

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ranked as the least effective of the 36 comments suggested that the image to higher ratings of feeling discouraged proposed images by respondents in the should show more severe disease or from wanting to smoke than a text-only submitter’s study, while another noted more clear association between the girl’s control in one submitter’s study. The that the image was ranked the lowest by illness and smoke exposure. image was also one of the five images a considerable margin of the images (Response) We are not selecting this rated most effective among the images proposed for use with this warning image for use in a required warning and used in FDA’s 36 proposed required statement in the submitter’s study. instead have selected the image ‘‘smoke warnings in another submitter’s study of (Response) We are not selecting this approaching baby’’ for the reasons given the potential effectiveness of the images. image for use in a required warning and in section III.D of this document. FDA also received several comments instead have selected the image ‘‘smoke 3. ‘‘WARNING: Cigarettes Cause Fatal that opposed use of the image ‘‘toe tag,’’ approaching baby’’ for the reasons given Lung Disease’’ with some submitters indicating that in section III.D of this document. consumers, and in particular minority Girl in oxygen mask. In FDA’s As discussed in section III.D of this populations, might not understand what research study, the image ‘‘girl in document, FDA selected the image the image of a toe tag signifies. Some oxygen mask’’ had significant effects on ‘‘healthy/diseased lungs’’ for use with comments stated that the image all the salience measures (emotional the statement, ‘‘WARNING: Cigarettes ‘‘offend[s] against human dignity’’ or is reaction scale, cognitive reaction scale, cause fatal lung disease.’’ FDA proposed ‘‘too sensational to be effective,’’ while and difficult to look at measure) in all three other images for use with this it was alternatively stated that the image three study populations (adults, young statement: ‘‘toe tag,’’ which appears on should be more graphic or show more adults, and youth). pages 21 and 22 of the document suffering. It was also noted in the However, the image had a significant ‘‘Proposed Required Warning Images;’’ comments that the image did not test as negative impact on adult beliefs about ‘‘lungs full of cigarettes,’’ which appears well as other images proposed for use the health risks of secondhand smoke on pages 23 and 24 of the document with this warning statement in FDA’s exposure for nonsmokers, i.e., adults ‘‘Proposed Required Warning Images;’’ research study. who viewed the image were less likely and ‘‘Dr. [doctor] with X-ray,’’ which (Response) We are not selecting this to believe that nonsmokers will suffer appears on pages 27 and 28 of the image for use in a required warning and from negative health effects due to document ‘‘Proposed Required Warning instead have selected the image secondhand smoke exposure than adults Images.’’ ‘‘healthy/diseased lungs’’ for the reasons who viewed the text-only control. Toe tag. In FDA’s research study, the given in section III.D of this document. As discussed in section III.D of this image ‘‘toe tag’’ had significant effects Lungs full of cigarettes. In FDA’s document, the selected image, ‘‘smoke on all the salience measures (emotional research study, the image ‘‘lungs full of approaching baby,’’ had significant reaction scale, cognitive reaction scale, cigarettes’’ had significant effects on all impacts on all the salience measures in and difficult to look at measure) in all the salience measures (emotional all three study populations, and also three study populations (adults, young reaction scale, cognitive reaction scale, showed significant impacts on recall adults, and youth). and behavioral intentions in some However, as discussed in section III.D and difficult to look at measure) in all populations. Thus, the selected image of this document, the selected image, three study populations (adults, young was considered to be a stronger choice ‘‘healthy/diseased lungs,’’ had the adults, and youth). than ‘‘girl in oxygen mask,’’ as it numerically largest effects of the images However, as discussed in section III.D showed positive effects on several proposed for use with this warning of this document, the selected image, important measures, but did not show statement on all the salience measures ‘‘healthy/diseased lungs,’’ had the any negative effects. in all three study populations. numerically largest effects of the images FDA received a number of comments The image ‘‘toe tag’’ prompted lower proposed for use with this warning on this image, which the Agency has correct recall of the warning statement statement on all the salience measures summarized and responded to in the than the text-only control at baseline in all three study populations. following paragraphs. among youth. Among young adults, the image (Comment 97) FDA received a number FDA received a number of comments ‘‘lungs full of cigarettes’’ prompted of comments that supported the use of on this image, which the Agency has higher correct recall of the warning the image ‘‘girl in oxygen mask,’’ summarized and responded to in the statement at baseline and at 1 week including comments from individuals, a following paragraphs. follow-up than the text-only control. public health advocacy group, a medical (Comment 98) FDA received a number The required warning featuring this organization, a health care professional, of comments that supported the use of image also prompted higher correct and a State public health agency, with the image ‘‘toe tag,’’ including recall of the image at baseline and some comments noting that the image comments from individuals, a medical follow-up among adults and youth than clearly conveys the message that smoke organization, public health advocacy some of the other images proposed for exposure can harm children, and groups, academics, and State and local use with this warning statement. powerfully shows the consequences of public health agencies. Some of these FDA received a number of comments smoking. comments indicated that the image is on this image, which the Agency has FDA also received several comments the best choice for use with this warning summarized and responded to in the that opposed use of the image ‘‘girl in statement. It was also noted that the following paragraphs. oxygen mask.’’ Some comments noted image effectively communicates the (Comment 99) FDA received some that it was unclear that the person risks of smoking and would effectively comments that supported the use of the portrayed in the image was a child, and deter smokers. image ‘‘lungs full of cigarettes,’’ suggested that the image would be more Some comments noted that the image including comments from individuals persuasive if the person shown were showed positive effects in research and State and local public health younger. One comment expressed studies conducted by the submitters. agencies. Some of these comments concern that persons of low Specifically, this image was rated highly indicated that the image is the best socioeconomic status would not on its ease of comprehension and choice for use with this warning understand the image, and a few induced relatively greater worry and led statement, while some also noted that

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the image is particularly appropriate for the text-only control, as well as higher effects on some measures in FDA’s use with the warning statement. correct recall of the warning statement research study, and that it showed As discussed in section III.C of this at follow-up among youth and the adult negative effects on the beliefs measure document, some comments submitted to sample that viewed a hypothetical among some of the study participants. the docket described the results of advertisement featuring this proposed (Response) We are not selecting this research conducted by the submitters to required warning. image for use in a required warning and examine the potential effectiveness of However, among young adults, as instead have selected the image FDA’s proposed images. This image was well as among the adult sample who ‘‘healthy/diseased lungs’’ for the reasons discussed in some of these comments. viewed a hypothetical advertisement given in section III.D of this document. Specifically, in one submitter’s study, featuring this image, ‘‘Dr. with X-ray’’ 4. ‘‘WARNING: Cigarettes Cause participants rated this image highly on was negatively associated with beliefs Cancer’’ its ease of comprehension. It also about the health risks of secondhand induced relatively greater worry and smoke exposure to nonsmokers (i.e., As discussed in section III.D of this feelings of discouragement from participants viewing this image were document, FDA selected the image wanting to smoke than a text-only less likely to believe that nonsmokers ‘‘cancerous lesion on lip’’ for use with control. However, the image was rated will suffer health consequences related the statement, ‘‘WARNING: Cigarettes as one of the least effective of the images to secondhand smoke exposure than cause cancer.’’ FDA proposed three proposed by FDA for use with this participants viewing the text-only other images for use with this statement: warning statement in another control). ‘‘Deathly ill woman,’’ which appears on submitter’s study of the potential FDA received a number of comments pages 29 and 30 of the document effectiveness of the images. on this image, which the Agency has ‘‘Proposed Required Warning Images;’’ FDA also received several comments summarized and responded to in the ‘‘white cigarette burning,’’ which that opposed use of the image ‘‘lungs following paragraphs. appears on pages 31 and 32 of the full of cigarettes,’’ with some submitters (Comment 100) FDA received some document ‘‘Proposed Required Warning indicating that consumers might not comments that supported the use of the Images;’’ and ‘‘red cigarette burning,’’ understand the image, and some image ‘‘Dr. with X-ray,’’ including which appears on pages 35 and 36 of the comments stating that the image should comments from individuals, a public document ‘‘Proposed Required Warning show the consequences of lung disease health advocacy group, a community Images.’’ on a real person or on real lungs and organization, and a State public health Deathly ill woman. The image suggesting that the proposed image did agency. These comments noted that the ‘‘deathly ill woman’’ had strong overall not depict health consequences in an ‘‘Dr. with X-ray’’ image is particularly research results in FDA’s research understandable, hard-hitting manner. appropriate for use with the warning study, including significant effects on One comment noted that the secondary statement, or expressed the view that all the salience measures (emotional message highlighted by the use of bold the image is the best choice for use with reaction scale, cognitive reaction scale, face emphasis in this proposed required this warning statement. and difficult to look at measure) in all warning (‘‘I cause disease’’), could be As discussed in section III.C of this three study populations (adults, young interpreted as blaming smokers for their document, some comments submitted to adults, and youth). addiction, and expressed concern that the docket described the results of However, overall the selected image, this could undermine the proposed research conducted by the submitters to ‘‘cancerous lesion on lip,’’ had slightly required warning’s ability to examine the potential effectiveness of higher numerical scores on the communicate effectively with smokers. FDA’s proposed required warnings. This emotional and cognitive reaction scales One comment also stated that the image image was discussed in some of these than this image. did not show desirable effects on some comments. Specifically, this image was Among adults, the image ‘‘deathly ill measures in FDA’s research study. rated highly on its ease of woman’’ prompted lower correct recall (Response) We are not selecting this comprehension in one submitter’s of the warning statement at baseline and image for use in a required warning and study, but failed to show an effect on at 1 week follow-up. However, the instead have selected the image other study measures (worry, image showed some of the largest effect ‘‘healthy/diseased lungs’’ for the reasons discouragement from smoking). The sizes for image recall (baseline and given in section III.D of this document. image was one of the five images rated follow-up) across the images proposed Dr. with X-ray. In FDA’s research least effective among the images used in for use with this warning statement. study, the image ‘‘Dr. [doctor] with X- FDA’s 36 proposed required warnings in FDA received a number of comments ray’’ had significant effects on the another submitter’s study of the on this image, which the Agency has emotional and cognitive reaction scales potential effectiveness of the images, summarized and responded to in the in all three study populations (adults, and it was also rated as the least following paragraphs. young adults, and youth). It also had effective of the images proposed by FDA (Comment 101) FDA received a large significant effects on the difficult to look for use with this warning statement in number of comments that supported the at measure in adults and youth. another submitter’s study of the use of the image ‘‘deathly ill woman,’’ As discussed in section III.D of this potential effectiveness of the images. including comments from individuals, document, the selected image, ‘‘healthy/ FDA also received several comments public health advocacy groups, medical diseased lungs,’’ had significant effects that opposed use of the image ‘‘Dr. with organizations, academics, and State and on all the salience measures in all study X-ray,’’ with some submitters indicating local public health agencies. Many of populations, and had the largest that the X-ray shown in the image is these comments indicated that this numerical effects of the images unclear and that the image would not be image is the best image for use with this proposed for use with this warning understood by consumers, and some warning statement, with some stating statement on the salience measures. indicating that it was too vague or that the image would communicate Among young adults, the image ‘‘Dr. clinical in nature and did not effectively effectively to women and other with X-ray’’ prompted higher correct convey the full impact of lung disease. comments approving of the image’s recall of the warning statement at It was also noted in the comments that accurate portrayal of the effects cancer baseline and at 1 week follow-up than the image failed to show desirable can have on personal appearance.

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Some comments noted that the image summarized and responded to in the reaction scale, cognitive reaction scale, showed positive impacts in research following paragraphs. and difficult to look at measure) in all studies conducted by the submitters. (Comment 102) FDA received some three study populations (adults, young Specifically, in one submitter’s study, comments that supported the use of the adults, and youth). participants rated this image highly on image ‘‘white cigarette burning,’’ However, the selected image, its ease of comprehension. It also including comments from individuals ‘‘cancerous lesion on lip,’’ generally had induced relatively greater worry and and from State and local public health numerically larger effects than this feelings of discouragement from agencies. These comments noted that image on the salience measures. wanting to smoke than a text-only the ‘‘white cigarette burning’’ image is Among adults, young adults, and control. The submitter concludes that particularly appropriate for use with the youth, the image ‘‘red cigarette burning’’ this image, along with ‘‘cancerous lesion warning statement, or expressed the prompted lower correct recall of the on lip,’’ was the most effective of the submitter’s preference that the image be warning statement at baseline and at 1 images proposed for use with this used with this warning statement. week follow-up. The proposed required warning statement. The image was also As discussed in section III.C of this warning featuring this image also one of the five images rated most document, some comments submitted to prompted relatively lower recall of the effective among the images used in the docket described the results of image at baseline and at 1 week follow- FDA’s 36 proposed required warnings in research conducted by the submitters to up among adults, young adults, and another submitter’s study of the examine the potential effectiveness of youth than ‘‘cancerous lesion on lip.’’ potential effectiveness of the images. It FDA’s proposed images. This image was Youth viewing the image ‘‘red was also one of two images rated discussed in some of these comments. cigarette burning’’ reported being more effective among FDA’s 36 proposed Specifically, this image was rated highly likely to be smoking 1 year from now color graphic in another submitter’s on its ease of comprehension in one than youth viewing the text-only study of the effectiveness of the images submitter’s study, but failed to show an control. at stopping someone from smoking, and effect on other study measures (worry, FDA received a number of comments it was identified by high school students discouragement from smoking). The on this image, which the Agency has as one of the ‘‘top three’’ proposed image was rated as the least effective of summarized and responded to in the required warnings in another the images proposed by FDA for use following paragraphs. submitter’s study. with this warning statement in another (Comment 103) FDA received some FDA also received comments that submitter’s study of the potential comments that supported the use of the opposed the use of the image ‘‘deathly effectiveness of the images. image ‘‘red cigarette burning,’’ including ill woman.’’ Some comments noted that FDA also received several comments comments from individuals, a public the image ‘‘offend[s] against human that opposed use of the image ‘‘white health advocacy group, and from State dignity,’’ while one stated it was ‘‘too cigarette burning,’’ with some and local public health agencies. These sensational to be effective.’’ Conversely, submitters indicating that the image comments noted that the ‘‘red cigarette some comments indicated that the does not depict the negative health burning’’ image is particularly image should show more obvious signs consequences of smoking or that the appropriate for use with the warning of illness. It was also noted in the image is not appropriately evocative of statement, or expressed the submitter’s comments that the image did not show cancer, and some noting that the image preference that the image be used with desirable effects on all the measures in is unclear and will not be understood by this warning statement. FDA’s research study. consumers. Some comments also As discussed in section III.C of this (Response) We are not selecting this criticized the design of the image, and document, some comments submitted to image for use in a required warning and one stated that the image is not the docket described the results of instead have selected the image presented in color as required by the research conducted by the submitters to ‘‘cancerous lesion on lip’’ for the Tobacco Control Act. Some comments examine the potential effectiveness of reasons given in section III.D of this also noted that this image of a burning FDA’s proposed images. This image was document. cigarette could trigger cravings in discussed in some of these comments. White cigarette burning. In FDA’s smokers. It was also noted in the Specifically, in one submitter’s study, research study, the image ‘‘white comments that the image failed to show participants rated this image highly on cigarette burning’’ had significant effects desirable effects on some measures in its ease of comprehension. It also on the emotional and cognitive reaction FDA’s research study. One comment induced relatively greater worry and scales in all three study populations noted that the secondary message feelings of discouragement from (adults, young adults, and youth). It also highlighted by the use of bold face wanting to smoke than a text-only had significant effects on the difficult to emphasis in this proposed required control. In another submitter’s study, look at measure in adults. warning (‘‘I cause cancer’’) could be particular aspects of the image were As discussed in section III.D of this interpreted as blaming smokers, and evaluated, and the submitter reported document, the selected image, expressed concern that this could that the use of the color red to ‘‘cancerous lesion on lip,’’ had undermine the proposed required accentuate the warning content in ‘‘red significant effects on all the salience warning’s ability to communicate cigarette burning’’ was effective. measures in all study populations, and effectively with smokers. However, the image was rated as one of showed some of the numerically largest (Response) We are not selecting this the least effective of the images effects on these measures of all the image for use in a required warning and proposed by FDA for use with this images proposed for use with this instead have selected the image warning statement in another warning statement. ‘‘cancerous lesion on lip’’ for the submitter’s study of the potential Among youth, the image ‘‘white reasons given in section III.D of this effectiveness of the images, and the cigarette burning’’ prompted higher document. image was rated as one of the five least correct recall of the warning statement Red cigarette burning. In FDA’s effective images used in FDA’s 36 at baseline than the text-only control. research study, the image ‘‘red cigarette proposed required warnings in another FDA received a number of comments burning’’ had significant effects on all submitter’s study of the potential on this image, which the Agency has the salience measures (emotional effectiveness of the images.

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FDA also received several comments FDA received a number of comments Among adults, young adults, and that opposed use of the image ‘‘red on this image, which the Agency has youth, the image ‘‘red lightning with cigarette burning,’’ with some summarized and responded to in the heart’’ prompted higher correct recall of submitters indicating that the image following paragraphs. the warning statement at 1 week follow- does not depict the negative health (Comment 104) FDA received some up than the text-only control. However, consequences of smoking or that the comments that supported the use of the the proposed required warning featuring image is not appropriately evocative of image ‘‘hand with oxygen mask,’’ this image prompted relatively lower cancer. Some comments also criticized including comments from individuals, a recall of the image at baseline and at 1 the design of the image, with one stating community organization, and State week follow-up among youth than the that it looked like an image from a public health agencies. These comments selected image, ‘‘oxygen mask on man’s cigarette advertisement. Some noted that the ‘‘hand with oxygen face.’’ comments also noted that this image of mask’’ image is the best image for use FDA received several comments on a burning cigarette could trigger with the warning statement or stated this image, which the Agency has cravings in smokers. It was also noted that the image was appropriate for use summarized and responded to in the in the comments that the image failed to with this warning statement. following paragraphs. show desirable effects on some As discussed in section III.C of this (Comment 105) FDA received a few measures in FDA’s research study and document, some comments submitted to comments that supported the use of the showed some undesirable effects. Some the docket described results of research image ‘‘red lightning with heart,’’ comments also suggested that other conducted by the submitters to examine including comments from State and cancers, including bladder cancer, the potential effectiveness of FDA’s local public health agencies, which should be added to the cancers listed in proposed images. This image was noted that this image is appropriate for the image. discussed in some of these comments. use with the warning statement. As discussed in section III.C of this (Response) We are not selecting this Specifically, this image was rated highly document, some comments submitted to image for use in a required warning and on its ease of comprehension and the docket described results of research instead have selected the image induced relatively greater worry and led conducted by the submitters to examine ‘‘cancerous lesion on lip’’ for the to higher ratings of feeling discouraged the potential effectiveness of FDA’s reasons given in section III.D of this from wanting to smoke than a text-only proposed images. This image was document. control in one submitter’s study. discussed in some of these comments. However, the image was rated as the 5. ‘‘WARNING: Cigarettes Cause Strokes Specifically, this image was rated highly least effective of the images proposed by and Heart Disease’’ on its ease of comprehension in one FDA for use with this warning statement submitter’s study, but failed to show an As discussed in section III.D of this in another submitter’s study of the effect on other study measures (worry, document, FDA selected the image potential effectiveness of the images. discouragement from smoking). The ‘‘oxygen mask on man’s face’’ for use FDA also received several comments image was rated as one of the least with the statement, ‘‘WARNING: that opposed use of the image ‘‘hand effective of the images proposed by FDA Cigarettes cause strokes and heart with oxygen mask,’’ with some for use with this warning statement in disease.’’ FDA proposed three other submitters indicating that the image is another submitter’s study of the images for use with this statement: hard to understand or not appropriately potential effectiveness of the images. ‘‘hand with oxygen mask,’’ which compelling. Some comments also stated FDA also received several comments appears on pages 37 and 38 of the that the image would be more that opposed use of the image ‘‘red document ‘‘Proposed Required Warning appropriate for use with a statement lightning with heart,’’ with some Images;’’ ‘‘red lightning with heart,’’ about lung-related health consequences submitters criticizing the design of the which appears on pages 41 and 42 of the (such as COPD). It was also noted in the image, which was characterized as too document ‘‘Proposed Required Warning comments that the image failed to show conceptual and not easily Images;’’ and ‘‘man in pain with hand desirable effects on some measures in understandable. Some comments also on chest,’’ which appears on pages 43 FDA’s research study and showed some criticized the illustration style, stating and 44 of the document ‘‘Proposed undesirable effects. that it does not have the impact a Required Warning Images.’’ (Response) We are not selecting this photograph would have, and would not Hand with oxygen mask. In FDA’s image for use in a required warning and compel or move viewers, and may research study, the image ‘‘hand with instead have selected the image ‘‘oxygen inappropriately appeal to youth without oxygen mask’’ had significant effects on mask on man’s face’’ for the reasons discouraging them from smoking. It was all the salience measures (emotional given in section III.D of this document. also noted in the comments that the reaction scale, cognitive reaction scale, Red lightning with heart. In FDA’s image failed to show desirable effects on and difficult to look at measure) in all research study, the image ‘‘red lightning some measures in FDA’s research study. three study populations (adults, young with heart’’ had significant effects on (Response) We are not selecting this adults, and youth). the emotional and cognitive reaction image for use in a required warning and However, the selected image, ‘‘oxygen scales in all three study populations instead have selected the image ‘‘oxygen mask on man’s face,’’ also had (adults, young adults, and youth). The mask on man’s face’’ for the reasons significant effects on all the salience image also had significant effects on the given in section III.D of this document. measures, and generally had difficult to look at measure in adults Man in pain with hand on chest. In numerically larger effects than this and young adults. FDA’s research study, the image ‘‘man image on the emotional reaction scale However, the selected image, ‘‘oxygen in pain with hand on chest’’ had and the difficult to look at measure. mask on man’s face,’’ had significant significant effects on the emotional Adults viewing the image ‘‘hand with effects on all the salience measures in reaction scale in all three study oxygen mask’’ reported being less likely all the study populations, and it populations (adults, young adults, and to quit smoking within the next month generally had numerically larger effects youth). The image also had significant than adults viewing the text-only than this image on the salience effects on the cognitive reaction scale in control. measures. young adults and youth, as well as in

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adults viewing a hypothetical as older smokers. One comment research conducted by the submitters to advertisement containing ‘‘man in pain suggested that the man shown in the examine the potential effectiveness of with hand on chest.’’ The image also image should be replaced with a man of FDA’s proposed images. This image was had significant effects on the difficult to color. It was also stated in the comments discussed in some of these comments. look at measure in adults and youth. that the image failed to show large Specifically, this image was rated highly However, the selected image, ‘‘oxygen effects on salience measures or to show on its ease of comprehension compared mask on man’s face,’’ had significant desirable effects on other measures in to a text-only control in one submitter’s effects on all the salience measures in FDA’s research study. study, but failed to show an effect on all the study populations, and had (Response) We are not selecting this other study measures (worry, numerically larger effects than this image for use in a required warning and discouragement from smoking). The image on the salience measures. instead have selected the image ‘‘oxygen image was also rated as the most Among youth, the image ‘‘man in pain mask on man’s face’’ for the reasons effective of the images proposed by FDA with hand on chest’’ prompted higher given in section III.D of this document. for use with this warning statement in correct recall of the warning statement another submitter’s study of the at 1 week follow-up than the text-only 6. ‘‘WARNING: Smoking During Pregnancy Can Harm Your Baby’’ potential effectiveness of the images, but control. However, the proposed required an image used in another country was warning featuring this image prompted As discussed in section III.D of this rated significantly higher than either of relatively lower recall of the image at document, FDA selected the image FDA’s proposed images in this study baseline among adults than ‘‘oxygen ‘‘baby in incubator’’ for use with the (however, as discussed in section III.A mask on man’s face.’’ statement, ‘‘WARNING: Smoking during of this document, at this time FDA does FDA received a number of comments pregnancy can harm your baby.’’ FDA not believe it is necessary or appropriate on this image, which the Agency has proposed one other image for use with to use graphic warnings used in other summarized and responded to in the this statement: ‘‘pacifier & ashtray,’’ countries in place of the images following paragraphs. which appears on pages 47 and 48 of the developed by FDA). (Comment 106) FDA received several document ‘‘Proposed Required Warning comments that supported the use of the FDA also received several comments Images.’’ that opposed use of the image ‘‘pacifier image ‘‘man in pain with hand on Pacifier & ashtray. In FDA’s research & ashtray,’’ with some submitters chest,’’ including comments from study, the image ‘‘pacifier & ashtray’’ criticizing the design of the image, individuals, public health advocacy had significant effects on the emotional which was characterized as too groups, a health care professional, and and cognitive reaction scales in all three symbolic and abstract to be understood, a State public health agency. Several of study populations (adults, young adults, and as lacking in emotional impact. these comments indicated that this and youth). The image also had Some comments stated that the image image is the best choice for use with this significant effects on the difficult to look does not show a health consequence of warning statement, with some at measure in adults and youth. comments noting that the image However, the selected image, ‘‘baby in smoking, and some indicated the image appropriately shows how painful heart incubator,’’ had significant effects on all is not graphic enough. A few comments attacks can be. the salience measures in all the study also noted that the image would be more As discussed in section III.C of this populations, and had numerically larger appropriate for a warning related to document, some comments submitted to effects than this image on all the post-partum secondhand smoke-related the docket described results of research salience measures. risks, rather than a pregnancy warning, conducted by the submitters to examine Among young adults, the image because pacifiers are used post- rather the potential effectiveness of FDA’s ‘‘pacifier & ashtray’’ prompted higher than pre-partum. One comment stated proposed images. This image was correct recall of the warning statement that the background used for the textual discussed in some of these comments. at baseline and at 1 week follow-up than warning statement in the image looks Specifically, in one submitter’s study, the text-only control. However, the unprofessional. It was also stated in the participants rated this image highly on proposed required warning featuring comments that the image failed to show its ease of comprehension. It also this image prompted relatively lower large effects on the salience measures or induced relatively greater worry and recall of the image at baseline and at 1 to show desirable effects on some other feelings of discouragement from week follow-up among adults, young measures in FDA’s research study. wanting to smoke than a text-only adults, and youth than the selected (Response) We are not selecting this control. However, the image was rated image, ‘‘baby in incubator.’’ image for use in a required warning and as less effective than the selected image, FDA received a number of comments instead have selected the image ‘‘baby ‘‘oxygen mask on man’s face,’’ in on this image, which the Agency has in incubator’’ for the reasons given in another submitter’s study of the summarized and responded to in the section III.D of this document. potential effectiveness of the images. following paragraphs. 7. ‘‘WARNING: Smoking Can Kill You’’ FDA also received several comments (Comment 107) FDA received several that opposed use of the image ‘‘man in comments that supported the use of the As discussed in section III.D of this pain with hand on chest.’’ Some image ‘‘pacifier & ashtray,’’ including document, FDA selected the image comments indicated that the image comments from individuals, public ‘‘man with chest staples’’ for use with looks like a man with a headache or health advocacy groups, and State and the statement, ‘‘WARNING: Smoking other ailment rather than a man local public health agencies. In general, can kill you.’’ FDA proposed three other suffering from heart disease or a stroke, these comments indicated that this images for use with this statement: ‘‘red and a few comments indicated the image is the best choice for use with this coffin with body,’’ which appears on man’s hand should be closer to his left warning statement, with some noting pages 51 and 52 of the document side (where his heart is). Some that the image is compelling and ‘‘Proposed Required Warning Images;’’ comments stated that the image should powerful. ‘‘man in casket,’’ which appears on feature a younger person to drive home As discussed in section III.C of this pages 53 and 54 of the document the message that heart disease and document, some comments submitted to ‘‘Proposed Required Warning Images;’’ strokes can affect young smokers as well the docket described the results of and ‘‘cigarettes = RIP,’’ which appears

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on pages 55 and 56 of the document with some indicating the image would feelings of discouragement from ‘‘Proposed Required Warning Images.’’ be more effective if it were a photograph wanting to smoke than a text-only Red coffin with body. In FDA’s of an actual person. It was also control. In another submitter’s study, research study, the image ‘‘red coffin suggested in the comments that the particular aspects of the image were with body’’ had significant effects on all image style may inappropriately appeal evaluated, and the proposed required the salience measures (emotional to youth without discouraging them warning containing the image ‘‘man in reaction scale, cognitive reaction scale, from smoking. Some comments noted casket’’ was found to be significantly and difficult to look at measure) in that the image failed to show desirable more effective at discouraging others adults and youth. It also had a effects on some measures in FDA’s from smoking than a text-only statement significant effect on the cognitive research study. on the side of a cigarette package. reaction scale in young adults. (Response) We are not selecting this However, the image was rated as less However, the selected image, ‘‘man image for use in a required warning and effective than the selected image, ‘‘man with chest staples,’’ had a significant instead have selected the image ‘‘man with chest staples,’’ in another effect on all the salience measures in all with chest staples’’ for the reasons given submitter’s study of the potential study populations, and had numerically in section III.D of this document. effectiveness of the images. larger effects than this image on these Man in casket. In FDA’s research FDA also received several comments measures. study, the image ‘‘man in casket’’ had that opposed use of the image ‘‘man in Among adults, the image ‘‘red coffin significant effects on all the salience casket.’’ Multiple comments stated the with body’’ prompted higher correct measures (emotional reaction scale, image looks staged because the man recall of the warning statement at cognitive reaction scale, and difficult to pictured does not look like he is dead baseline than the text-only control. look at measure) in adults and youth. It or like he suffered from smoking-related The image also had a significant also had a significant effect on the disease. It was also suggested in the impact on beliefs about the health risks cognitive reaction scale in young adults. comments that the image may not be of smoking for smokers relative to the However, the selected image, ‘‘man understood by all cultures. The image text-only control in the adult sample with chest staples,’’ had significant was also criticized as lacking a clear that viewed a hypothetical effects on all the salience measures, and association to smoking. It was also advertisement containing the proposed generally had numerically larger effects noted in the comments that the image required warning. than this image on these measures. failed to show desirable effects on some FDA received a number of comments Among youth, the image ‘‘man in measures in FDA’s research study. on this image, which the Agency has casket’’ prompted higher correct recall (Response) We are not selecting this summarized and responded to in the of the warning statement at baseline image for use in a required warning and following paragraphs. than the text-only control. However, instead have selected the image ‘‘man (Comment 108) FDA received several among young adults, the image ‘‘man in with chest staples’’ for the reasons given comments that supported the use of the casket’’ prompted lower correct recall of in section III.D of this document. image ‘‘red coffin with body,’’ including the warning statement at baseline than comments from individuals and a the text-only control. Cigarettes = RIP. In FDA’s research community organization. Several of The image also had a significant study, the image ‘‘cigarettes = RIP’’ had these comments indicated that this impact on beliefs about the health risks significant effects on all the salience image is the best choice for use with this of smoking for smokers relative to the measures (emotional reaction scale, warning statement, with some text-only control in the adult sample cognitive reaction scale, and difficult to approving of the colors used in the that viewed a hypothetical look at measure) in adults and youth. It image and some noting that the image advertisement containing the proposed also had a significant effect on the gets the message across in a required warning. emotional and cognitive reaction scales straightforward manner. FDA received a number of comments in young adults. As discussed in section III.C of this on this image, which the Agency has However, the selected image, ‘‘man document, some comments submitted to summarized and responded to in the with chest staples,’’ had significant the docket described the results of following paragraphs. effects on all the salience measures in research conducted by the submitters to (Comment 109) FDA received several all the study populations, and generally examine the potential effectiveness of comments that supported the use of the had numerically larger effects than this FDA’s proposed images. This image was image ‘‘man in casket,’’ including image on these measures. discussed in some of these comments. comments from individuals, a public Among adults, the image ‘‘cigarettes = Specifically, this image was rated highly health advocacy group, and a State RIP’’ prompted higher correct recall of on its ease of comprehension compared public health agency. Several of these the warning statement at baseline than to a text-only control in one submitter’s comments indicated that this image is the text-only control. However, the study, but failed to show an effect on the best choice for use with this warning proposed required warning featuring other study measures (worry, statement, with some noting that the this image prompted relatively lower discouragement from smoking). The image grabs viewers’ attention and recall of the image at baseline and at 1 image was rated as one of the least clearly depicts death. week follow-up than the selected image, effective of the images proposed by FDA As discussed in section III.C of this ‘‘man with chest staples.’’ for use with this warning statement in document, some comments submitted to The image had a significant impact on another submitter’s study of the the docket described the results of beliefs about the health risks of smoking potential effectiveness of the images. research conducted by the submitters to for smokers relative to the text-only FDA also received several comments examine the potential effectiveness of control in the adult sample that viewed that opposed use of the image ‘‘red FDA’s proposed images. This image was a hypothetical advertisement containing coffin with body,’’ with some submitters discussed in some of these comments. the proposed required warning. stating that the image is too conceptual Specifically, in one submitter’s study, FDA received a number of comments and not easily understandable. Several participants rated this image highly on on this image, which the Agency has comments stated that the image is not its ease of comprehension. It also summarized and responded to in the impactful and is unlikely to be effective, induced relatively greater worry and following paragraphs.

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(Comment 110) FDA received several proposed four other images for use with feelings of discouragement from comments that supported the use of the this statement: ‘‘graveyard,’’ which wanting to smoke than a text-only image ‘‘cigarettes = RIP,’’ including appears on pages 59 and 60 of the control. This image was also rated as the comments from individuals and a State document ‘‘Proposed Required Warning most effective of the images proposed by public health agency. Several of these Images;’’ ‘‘man smoke at woman,’’ FDA for use with this warning statement comments indicated that this image is which appears on pages 61 and 62 of the in another submitter’s study of the the best choice for use with this warning document ‘‘Proposed Required Warning potential effectiveness of the images, statement, with some noting that the Images;’’ ‘‘woman smoke at man,’’ although an image used in another image gets the message across in a which appears on pages 63 and 64 of the country was rated more highly than this straightforward manner, and one stating document ‘‘Proposed Required Warning image. that the image will get the attention of Images;’’ and ‘‘man hands up & smoke,’’ FDA also received several comments youth tobacco users. which appears on pages 65 and 66 of the that opposed use of the image As discussed in section III.C of this document ‘‘Proposed Required Warning ‘‘graveyard.’’ Some comments indicated document, some comments submitted to Images.’’ that the image would not be effective, the docket described the results of Graveyard. In FDA’s research study, noting that it is easy to disregard or, research conducted by the submitters to the image ‘‘graveyard’’ had significant alternatively, too sensational to be examine the potential effectiveness of effects on the emotional reaction scale effective. It was also stated in the FDA’s proposed images. This image was in all three study populations (adults, comments that the image did not show discussed in some of these comments. young adults, and youth). The image large impacts on the emotional reaction Specifically, this image was rated highly also had significant effects on the scale and failed to show desirable on its ease of comprehension compared cognitive reaction scale in young adults effects on some other measures in FDA’s to a text-only control in one submitter’s and youth, and on the difficult to look research study. study, but failed to show an effect on at measure in youth. (Response) We are not selecting this other study measures (worry, However, the selected image, ‘‘woman image for use in a required warning and discouragement from smoking). The crying,’’ had significant effects on the instead have selected the image image was rated as the least effective of salience measures in all study ‘‘woman crying’’ for the reasons given in populations, and it generally had the images proposed by FDA for use section III.D of this document. numerically larger effects than this with this warning statement in another Man smoke at woman. In FDA’s submitter’s study of the potential image on all the salience measures. Among adults and youth, the image research study, the image ‘‘man smoke effectiveness of the images. at woman’’ had significant effects on the FDA also received several comments ‘‘graveyard’’ prompted lower correct emotional and cognitive reaction scales that opposed use of the image recall of the warning statement at in adults, young adults, and youth. The ‘‘cigarettes = RIP,’’ with some submitters baseline than the text-only control. image also had significant effects on the stating that the image is too conceptual Among young adults, the image or indirect and lacks impact, and will prompted lower correct recall of the difficult to look at measure in youth. not be effective in deterring smoking. warning statement at 1 week follow-up However, the selected image, ‘‘woman Several comments expressed concern than the text-only control. crying,’’ had significant effects on the that consumers, including individuals The image ‘‘graveyard’’ had a salience measures in all study from various cultures with limited significant impact on beliefs about the populations, and had numerically larger English proficiency and children, might health risks of smoking for smokers in effects than this image on the emotional not understand what the shapes of the young adults. reaction scale and the difficult to look cigarette package and tombstone FDA received a number of comments at measure in all study populations. represent, or understand the on this image, which the Agency has The proposed required warning abbreviation (‘‘RIP’’) used in the image. summarized and responded to in the featuring this image prompted relatively Some comments criticized the style of following paragraphs. lower recall of the image at baseline and the image, with some characterizing it (Comment 111) FDA received several at 1 week follow-up than the selected as low quality and others objecting on comments that supported the use of the image, ‘‘woman crying.’’ the grounds that it downplays the image ‘‘graveyard,’’ including comments The image ‘‘man smoke at woman’’ seriousness of the risk being conveyed from individuals, a community had a significant impact on beliefs about and may inappropriately appeal to organization, and a State public health the health risks of smoking for smokers youth without discouraging them from agency. Several of these comments in young adults. smoking. It was also stated in the indicated that this image is the best FDA received a number of comments comments that the image failed to show choice for use with this warning on this image, which the Agency has large effects on the salience measures or statement, with some noting that the summarized and responded to in the to show desirable effects on some other image gets the message across in a following paragraphs. measures in FDA’s research study. straightforward manner, and some (Comment 112) FDA received several (Response) We are not selecting this noting the image could deter people comments that supported the use of the image for use in a required warning and from starting to smoke. image ‘‘man smoke at woman,’’ instead have selected the image ‘‘man As discussed in section III.C of this including comments from individuals with chest staples’’ for the reasons given document, some comments submitted to and State public health agencies. in section III.D of this document. the docket described the results of Several of these comments indicated research conducted by the submitters to that this image is the best choice for use 8. ‘‘WARNING: Tobacco Smoke Causes examine the potential effectiveness of with this warning statement, with some Fatal Lung Disease in Nonsmokers’’ FDA’s proposed images. This image was noting that the image would make As discussed in section III.D of this discussed in some of these comments. smokers think about how their habit document, FDA selected the image Specifically, in one submitter’s study, may cause others to avoid them. It was ‘‘woman crying’’ for use with the participants rated this image highly on also noted that the image effectively statement, ‘‘WARNING: Tobacco smoke its ease of comprehension. It also shows how innocent bystanders are causes fatal lung disease.’’ FDA induced relatively greater worry and affected by smokers.

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As discussed in section III.C of this required warning featuring this image up & smoke’’ had significant effects on document, some comments submitted to also prompted relatively lower recall of the emotional reaction scale in all study the docket described the results of the image at baseline and at 1 week populations (adults, young adults, and research conducted by the submitters to follow-up than the selected image, youth) and on the cognitive reaction examine the potential effectiveness of ‘‘woman crying.’’ scale in young adults and youth. FDA’s proposed images. This image was The image ‘‘woman smoke at man’’ However, the selected image, ‘‘woman discussed in some of these comments. had a significant impact on young crying,’’ had significant effects on all the Specifically, in one submitter’s study, adult’s intentions to quit smoking in the salience measures in all study participants rated this image highly on next month compared to the text-only populations, and it had numerically its ease of comprehension. It also control. larger effects than this image on all induced relatively greater worry and FDA received a number of comments these measures. feelings of discouragement from on this image, which the Agency has The proposed required warning wanting to smoke than a text-only summarized and responded to in the featuring the image ‘‘man hands up & control. The submitter also concluded following paragraphs. smoke’’ also prompted relatively lower that the image was the most effective of (Comment 113) FDA received several correct recall of the image at baseline the images proposed for use with this comments that supported the use of the and at 1 week follow-up than the warning statement. However, the image image ‘‘woman smoke at man,’’ selected image, ‘‘woman crying.’’ was rated as one of the less effective including comments from individuals, a FDA received several comments on images proposed by FDA for use with public health advocacy group, a medical this image, which the Agency has this warning statement in another organization, and State and local public summarized and responded to in the submitter’s study of the potential health agencies. Several of these following paragraphs. effectiveness of the images. comments indicated that this image is (Comment 114) FDA received some FDA also received several comments the best choice for use with this warning comments that supported the use of the that opposed use of the image ‘‘man statement, with some noting that the image ‘‘man hands up & smoke,’’ smoke at woman.’’ Some comments image will make smokers think about including comments from individuals indicated that the image is not realistic, how their actions negatively affect and a State public health agency. These stating that smokers do not blow smoke social situations. comments generally indicated that this at their friends. One comment indicated As discussed in section III.C of this image would be the best choice for use that the image failed to portray an document, some comments submitted to with this warning statement. obvious health consequence of the docket described the results of As discussed in section III.C of this secondhand smoke, and multiple research conducted by the submitters to document, some comments submitted to comments indicated that the image examine the potential effectiveness of the docket described the results of conveyed a bad message by showing the FDA’s proposed images. This image was research conducted by the submitters to nonsmoker covering her nose and discussed in some of these comments. examine the potential effectiveness of mouth, stating that these actions do not Specifically, this image was rated highly FDA’s proposed images. This image was protect you from secondhand smoke. It on its ease of comprehension compared discussed in some of these comments. was also noted in the comments that the to a text-only control in one submitter’s Specifically, this image was rated highly image failed to show desirable effects on study but failed to show an effect on on its ease of comprehension compared some measures in FDA’s research study. other study measures (worry, to a text-only control in one submitter’s (Response) We are not selecting this discouragement from smoking). The study, but it failed to show an effect on image for use in a required warning and image was rated as one of the least other study measures (worry, instead have selected the image effective of the images proposed by FDA discouragement from smoking). The ‘‘woman crying’’ for the reasons given in for use with this warning statement in image was rated as the least effective of section III.D of this document. another submitter’s study of the the images proposed by FDA for use Woman smoke at man. In FDA’s potential effectiveness of the images. with this warning statement in another research study, the image ‘‘woman FDA also received several comments submitter’s study of the potential smoke at man’’ had significant effects on that opposed use of the image ‘‘woman effectiveness of the images. the emotional reaction scale in adults, smoke at man.’’ Some comments FDA also received several comments young adults, and youth. The image also indicated that the image would not be that opposed use of the image ‘‘man had significant effects on the cognitive effective, suggesting that it is not hands up & smoke.’’ Some comments reaction scale in young adults and impactful and probably would not stop indicated that the image is unrealistic in youth, and on the difficult to look at people from smoking. One comment that it looks like the man is in fog or a measure in adults and youth. indicated that the image fails to portray house fire as opposed to being affected However, the selected image, ‘‘woman an obvious health consequence of by secondhand smoke. One comment crying,’’ had significant effects on the secondhand smoke, and another was indicated that the image does not salience measures in all study critical of the actions of the nonsmoker portray a health consequence of populations, and it had numerically in the image, noting that covering your secondhand smoke; it was also stated in larger effects than this image on the nose and mouth does not protect you the comments the image is ineffective emotional reaction scale and the from secondhand smoke. It was also and unintentionally humorous. One difficult to look at measure in all study stated in the comments that the image comment stated that the image failed to populations. failed to show desirable effects on some show large effects on salience measures Among adults, the image ‘‘woman measures in FDA’s research study. or to show desirable effects on other smoke at man’’ prompted higher correct (Response) We are not selecting this measures in FDA’s research study and recall of the warning statement at 1 image for use in a required warning and indicated it should not be selected. week follow-up than the text-only instead have selected the image (Response) We are not selecting this control. However, among young adults, ‘‘woman crying’’ for the reasons given in image for use in a required warning and the image prompted lower correct recall section III.D of this document. instead have selected the image of the warning statement at baseline Man hands up & smoke. In FDA’s ‘‘woman crying’’ for the reasons given in than the text-only control. The proposed research study, the image ‘‘man hands section III.D of this document.

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9. ‘‘WARNING: Quitting Smoking Now image was rated as less effective than examine the potential effectiveness of Greatly Reduces Serious Risks to Your the selected image, ‘‘man I Quit t-shirt,’’ FDA’s proposed images. This image was Health’’ in another submitter’s study of the discussed in some of these comments. As discussed in section III.D of this potential effectiveness of the images. Specifically, this image led to lower FDA also received several comments document, FDA selected the image levels of worry and lower reports of that opposed use of the image ‘‘man I Quit t-shirt’’ for use with the feeling discouraged from smoking ‘‘cigarettes in toilet bowl.’’ These statement, ‘‘WARNING: Quitting relative to a text-only control in one comments noted that the image is not smoking now greatly reduces serious submitter’s study. In addition, the image clear or does not convey a health was rated as the least effective of the risks to your health.’’ FDA proposed two consequence of smoking. It was also images proposed by FDA for use with other images for use with this statement: noted that the image is not easily this warning statement in another ‘‘cigarettes in toilet bowl,’’ which understood, or alternatively, that it is submitter’s study of the potential appears on pages 69 and 70 of the banal. Multiple comments expressed effectiveness of the images. document ‘‘Proposed Required Warning concern about what is shown in the FDA also received several comments Images;’’ and ‘‘woman blowing bubble,’’ image, stating that it recommends a bad that opposed use of the image ‘‘woman which appears on pages 71 and 72 of the or unhealthy action (i.e., flushing blowing bubble.’’ Multiple comments document ‘‘Proposed Required Warning cigarettes down a toilet, which the stated that the image is confusing and is Images.’’ comments stated could clog the toilet not appropriately compelling and would Cigarettes in toilet bowl. In FDA’s and pollute the environment). Some not be effective in encouraging smokers research study, the image ‘‘cigarettes in comments also stated that the statement to quit. Some comments indicated that toilet bowl’’ had significant effects on was difficult to read in the ‘‘cigarettes in the image does not effectively convey the emotional reaction scale in adults toilet bowl’’ image. It was also stated in the message contained in the warning and young adults and significant effect the comments that the image did not statement, and some noted that the on the cognitive reaction scale in all show large effects on the emotional and image is banal or, alternatively, too study populations (adults, young adults, cognitive reaction scales in FDA’s positive. Multiple comments also stated and youth). research study and failed to show the image is hard to understand, and Among youth, the image ‘‘cigarettes in desirable effects on other measures. that smokers may not comprehend the toilet bowl’’ prompted higher correct (Response) We are not selecting this association between the image and the recall of the warning statement at 1 image for use in a required warning and warning statement. It was also stated week follow-up than the text-only instead have selected the image ‘‘man I that the image would inappropriately control. However, the proposed required Quit t-shirt’’ for the reasons given in appeal to youth without discouraging warning featuring this image prompted section III.D of this document. them from smoking, and that the image relatively lower recall of the image at Woman blowing bubble. In FDA’s is inappropriate because it is sexually baseline and at 1 week follow-up than research study, the image ‘‘woman suggestive. It was also noted in the the selected image, ‘‘man I Quit t-shirt.’’ blowing bubble’’ had a significant effect comments that the image showed The image ‘‘cigarettes in toilet bowl’’ on the cognitive reaction scale in youth. negative results on some measures in had a significant impact on beliefs about The image ‘‘woman blowing bubble’’ FDA’s research study, and failed to the health risks of smoking for smokers had a negative impact on youth beliefs show desirable effects on other in young adults. about the health risks of smoking for measures. FDA received a number of comments smokers and for nonsmokers (i.e., youth (Response) We are not selecting this on this image, which the Agency has who viewed this image were less likely image for use in a required warning and summarized and responded to in the to believe that smokers will suffer have instead selected the image ‘‘man I following paragraphs. negative health consequences or that Quit t-shirt’’ for the reasons given in (Comment 115) FDA received some nonsmokers exposed to secondhand section III.D of this document. comments that supported the use of the smoke will suffer negative health image ‘‘cigarettes in toilet bowl,’’ consequences than youth who viewed 10. Image for Advertisements With a including comments from individuals, a the text-only control). Furthermore, the Small Surface Area community organization, and a local adult sample that viewed a hypothetical As discussed in section III.D of this public health agency. Some comments advertisement containing the proposed document, FDA selected the image noted that this image is the best choice required warning reported that they which appears on page 75 of the for use with this warning statement, and were less likely to quit smoking in the document entitled ‘‘Proposed Required it was also noted in the comments that next 30 days compared to adults who Warning Images’’ for use with the the image is effective because it creates viewed the text-only control. textual warning statements solely in an association between cigarettes and (Comment 116) FDA received some advertisements with a small surface area other undesirable things that belong in comments that supported the use of the (defined as less than 12 square inches). a toilet bowl. image ‘‘woman blowing bubble,’’ We also proposed one other image for As discussed in section III.C of this including comments from individuals, a use with this statement, which appears document, some comments submitted to public health advocacy group, and a on page 74 of the document entitled the docket described the results of State public health agency. Multiple ‘‘Proposed Required Warning Images.’’ research conducted by the submitters to comments noted that the image The proposed image on page 74 examine the potential effectiveness of appropriately shows how quitting depicts a burning cigarette enclosed by FDA’s proposed images. This image was smoking allows for a better lung a red circle with a red bar across the discussed in some of these comments. capacity or noted that it effectively image. We did not receive any Specifically, this image failed to show conveys the idea that there are comments on either of the proposed any significant effects in one submitter’s beneficial effects of quitting. images. study on measures of ease of As discussed in section III.C of this As explained in section III.D of this comprehension, worry, and feeling document, some comments submitted to document, we have selected the image discouraged from smoking compared to the docket described the results of of a black exclamation mark enclosed a text-only control. In addition, the research conducted by the submitters to within a red equilateral triangle for use

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in advertisements with a small surface made to the text of some of the warning HIGHLY addictive,’’ while another area because we have concluded that statements in the 36 proposed required comment suggested the statement read the common purpose of this image, to warnings, we received numerous ‘‘Cigarettes are addictive and shorten denote a warning of a threat to health comments requesting other changes to your life.’’ Similarly, a comment from a or of a hazard which could result in the textual statements for the new health care professional suggested the personal injury, makes it the most required warnings, including requests to warning should state ‘‘Cigarettes are appropriate for use in the required strengthen the text, to add additional addictive and deadly.’’ Another warning context. information to the text or to otherwise comment from a nonprofit foundation modify the text of the warnings suggested that the statement ‘‘Cigarettes IV. Comments Regarding Textual statements. We also received requests to cause strokes and heart disease’’ be Warning Statements substitute alternative warning modified to state ‘‘Cigarettes cause A. Changes to Textual Warning statements for some or all of the textual strokes, heart disease, and Statements statements and to expand the warning amputations.’’ statements by adding additional (Response) Section 202(b) of the As we explained in the proposed rule, statements regarding smoking-related Tobacco Control Act gives FDA the section 202(b) of the Tobacco Control risks. The comments, and our responses, authority to change the textual warning Act, amending section 4 of FCLAA (15 are summarized in the following statements if such a change would U.S.C. 1333), gives us the authority to paragraphs. We also received numerous promote greater public understanding of adjust the format, type size, color comments about our proposal to include the health risks associated with graphics, and text of any of the required a reference to a cessation resource in the smoking. However, at this point, we warning statements if such a change required warnings; these comments and decline to make the recommended ‘‘would promote greater public our responses are summarized in changes. We are adopting the nine understanding of the risks associated section V.B.6 of this document. textual statements mandated by with the use of tobacco products.’’ In (Comment 117) Several comments Congress in section 4(a)(1) of FCLAA. addition, under section 4(d) of FCLAA, suggested that some of the textual The nine new textual warning FDA may adjust the type size, text, and warning statements should be changed statements objectively communicate format of the warning statements as the to include language asserted to be some of the major health risks Agency determines appropriate ‘‘so that stronger and more direct. For example, associated with smoking in an effective both the graphics and the accompanying multiple comments suggested that the manner. The new textual statements label statements are clear, conspicuous, statement, ‘‘WARNING: Tobacco smoke represent a significant improvement legible and appear within the specified can harm your children,’’ should be over the current set of warnings in that area.’’ Such adjustments, including reworded to be more assertive, for they are specific, unambiguous, and adjustments to the text and format of example, to state ‘‘Tobacco smoke succinctly describe documented some of the warning statements, were harms your children.’’ One comment outcomes of cigarette use and exposure. included with some of the proposed referenced the conclusion from the 2010 We conclude that these nine new warnings (75 FR 69524 at 69534). We Surgeon General’s report that there is no statements will effectively convey the did not receive comments about these risk-free level of exposure to major health risks of smoking, which adjustments. Two of the warning secondhand smoke as support for this will help discourage nonsmokers from statements we have selected for this modification (Ref. 37). Similarly, initiating cigarette use, and encourage final rule are presented in all uppercase multiple comments recommended that current smokers to consider cessation, letters, as they were in the proposal. In FDA change the warning statement, particularly when combined with addition, one of the proposed required ‘‘WARNING: Smoking during pregnancy graphic images depicting the negative warnings, ‘‘baby in incubator,’’ was can harm your baby,’’ to be more health consequences of smoking. presented without the signal word strongly worded. For instance, However, we intend to monitor the ‘‘WARNING.’’ The research literature on comments suggested this statement effects of these required warnings once graphic health warnings indicates that could instead be worded as they are put into use. We will conduct signal words, such as ‘‘Warning,’’ have ‘‘WARNING: Smoking during pregnancy research and keep abreast of scientific been found to enhance the noticeability harms your baby’’ or ‘‘WARNING: developments regarding the efficacy of of safety warnings and convey the Smoking when pregnant harms your various required warnings and the types degree of risk (see Ref. 40 at p. 33). In baby’’ or ‘‘WARNING: Smoking harms and elements of various warnings that the final rule, we are thus not removing your baby’’ or ‘‘WARNING: Smoking improve efficacy. Such research will the word ‘‘WARNING’’ from this harms the fetus and babies.’’ Multiple help inform us regarding whether to required warning, such that the text in comments also suggested the warning propose changes to the textual warning this required warning is the same as the statement ‘‘WARNING: Smoking can kill statements, such as by using stronger or text presented in section 201 of the you’’ should not be worded in a more direct language, in a future Tobacco Control Act (‘‘WARNING: conditional manner. One comment rulemaking. Smoking during pregnancy can harm suggested that the text could instead (Comment 118) Many comments your baby’’). state ‘‘Smoking kills.’’ recommended that FDA include Moreover, section 906(d) of the FD&C Similarly, FDA received a number of additional textual information to give Act (21 U.S.C. 387f(d)) authorizes FDA comments suggesting other further context for the health warnings. to issue regulations restricting the sale modifications that individuals, public For example, comments requested that or distribution of cigarettes and other health advocacy groups, health care FDA add information such as research tobacco products. As is discussed in professionals, community organizations, statistics, factual testimonials, or other more detail in section V.B.6 of this and other groups believed would explanatory text to further enhance the document, a reference to a cessation augment the nine statements. For effectiveness of the new required resource has been included in the final example, one comment from a public warnings. Several of the comments required warnings. health advocacy group suggested that suggested specific text for particular Although we did not receive any the statement ‘‘Cigarettes are addictive’’ warning statements; for example, one comments about the adjustments we be modified to state ‘‘Cigarettes are comment suggested the warning

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statement related to addiction be ‘‘cigarette smoke’’ to apply more health risks of smoking. Furthermore, accompanied by the following directly to the target audience. we disagree with the suggestion that explanatory text: ‘‘Studies have shown (Response) We disagree that this there should be fewer warnings about that tobacco can be harder to quit than change is warranted. The statements in the health risks of smoking during heroin or cocaine.’’ Other comments section 4(a)(1) of FCLAA, including pregnancy and of secondhand smoke to suggested that the statement those that reference ‘‘tobacco smoke,’’ children. These warnings comprise two ‘‘WARNING: Cigarettes cause cancer’’ be are scientifically accurate, and we do of the nine warning statements, and we modified to add explanatory text about not believe that consumers will fail to agree with the comments indicating that specific cancers caused by cigarettes, understand that the warning statements these warnings communicate including cancers of the mouth, throat, referencing ‘‘tobacco smoke’’ apply to information about important health esophagus, lungs, kidney, bladder, the products on which they appear (i.e., issues and will help smokers pancreas, stomach, cervix, and bone cigarettes), which are tobacco products. understand some of the significant marrow. Another comment suggested (Comment 120) FDA received a health harms caused by cigarettes. In that the statement ‘‘Cigarettes cause number of comments suggesting that addition, while these warnings may be strokes and heart disease’’ be some of the negative health effects that especially impactful with parents and accompanied by explanatory text stating are the subject of individual warning expectant parents, using a variety of ‘‘Cigarette smoking doubles your statements be replaced with other messages, including messages that may chances of strokes and can cause heart warnings. For example, one comment particularly impact certain audiences, attacks’’ and that the statement from a medical organization suggested will strengthen the overall impact of the ‘‘Cigarettes cause fatal lung disease’’ be that the statement ‘‘WARNING: Tobacco required warnings (Ref. 40 at pp. 7–8). accompanied by explanatory text stating smoke causes fatal lung disease in Similarly, we disagree with the that ‘‘Every cigarette you smoke nonsmokers’’ should instead focus on suggestion that the warning about increases your chances of dying from heart attacks, stating that the magnitude addiction should be replaced by a lung disease.’’ In addition, the comment of fatal heart disease caused by warning about other health hazards. As suggested that the statement ‘‘Tobacco secondhand smoke exposure is greater discussed in the preamble to the smoke causes fatal lung disease in than the magnitude of fatal lung disease proposed rule (75 FR 69524 at 69528 nonsmokers’’ be accompanied by caused by secondhand smoke exposure. through 69529), the magnitude of public explanatory text stating ‘‘You’re not the One comment from an individual health harm caused by cigarettes is only one smoking cigarettes. The smoke suggested that FDA use other warnings inextricably linked to the addictive is not just inhaled by smokers, it about the health harms of smoking nature of these products (Ref. 16 at p. 14 becomes second-hand smoke, which instead of the warning about addiction. and Ref. 3 at p. xi), and many people, contains more than 50 cancer agents.’’ Another comment suggested that particularly adolescents, have a poor Another comment suggested adding there should be fewer warnings understanding of how difficult it is to information to the required warnings regarding the health risks of secondhand quit smoking due to the addictive nature that state alternatives to smoking, such smoke to babies and children and more of cigarettes (Ref. 3 at p. 91). Thus, we as exercise and healthy eating. warnings directed at young teens and conclude this is an important and (Response) We decline to make such pre-teens. One comment stated that the appropriate health warning. changes at this time. As stated warnings about smoking during (Comment 121) One comment previously, the nine new textual pregnancy and about the harms of suggested that graphic health warnings warning statements mandated by tobacco smoke to children are only on cigarette packages and Congress in section 4(a)(1) of FCLAA relevant to those who are pregnant or advertisements should have one broad objectively communicate some of the who have children and suggested that warning that states: ‘‘Cigarette smoking major health risks associated with these warnings are thus less impactful may cause cancer, death, and other smoking in an effective manner. In than the other warning statements. serious life-threatening health hazards.’’ addition, research has shown that However, other comments stated that Another comment suggested one broad warning statements that are short and to the warnings about the risks of smoking warning that states: ‘‘Smoking Can Kill the point and that are presented in during pregnancy and about the health You.’’ larger fonts sizes are likely to be more risks of secondhand smoke to children (Response) We disagree. We are not effective (Ref. 40 at p. 33). If the address important health issues, will aware of any scientific evidence that additional requested information were help make smokers aware that they are one broad warning statement would be added to the required warnings, the harming innocent people around them, more effective in communicating the resulting warning statements would be and will help smokers appreciate the multitude of health risks to smokers and longer, and the font size of the warning severity and magnitude of some of the nonsmokers in all age categories than statements would likely decrease in lesser-known risks of smoking. One the nine specific textual warnings order for the information to fit within comment from an individual noted that specified in section 4(a) of FCLAA. the specified area. This could undercut secondhand smoke kills an estimated As noted in the proposed rule, the effectiveness of the warnings (see, 45,000 nonsmokers who live with evidence shows that warnings about e.g., Ref. 57). If research later indicates smokers from heart disease each year, as specific health risks, such as cancer, that adding such information to the new well as increasing the risk of SIDS, acute heart disease, and stroke, are more required warnings will promote a respiratory infections, ear problems, and effective than general warnings (75 FR greater understanding of the risks severe asthma in children, and causing 69524 at 69533 through 69534). associated with smoking, we will respiratory symptoms and slowing lung Utilizing a single broad statement like consider making these changes using growth in children. the ones proposed in the comments our authority under section 202(b) of the (Response) We decline to amend the would also fail to communicate Tobacco Control Act. warning statements as suggested by the important information about the (Comment 119) One comment comments. As stated previously, the detrimental effects associated with suggested that the warning statements nine textual statements provided by secondhand smoke—and messages that reference ‘‘tobacco smoke’’ should Congress in section 4(a)(1) of FCLAA about secondhand smoke have been be modified to instead reference appropriately communicate important effective in moving smokers to consider

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the health risks associating with results of our monitoring and such pack size and shape, which would help smoking (75 FR 69524 at 69534). For research to determine whether changes to ensure the readability of warnings. example, the new set of warnings should be made to the nine textual (Response) We do not believe it is includes the following statement: statements in a future rulemaking. We necessary to adopt a standard pack size ‘‘WARNING: Tobacco smoke causes recognize that cigarettes cause negative and shape. We have taken steps to fatal lung disease in nonsmokers.’’ This health consequences in both smokers ensure that the required warnings will important warning would be lost if we and nonsmokers beyond those be conspicuous and legible on cigarette chose to use just one of the suggested addressed in the nine warning packages and in advertisements. broad warning statements. In addition, statements provided by Congress, and B. Attribution to the Surgeon General one of the new required warnings will take this into account in making clearly notifies smokers that if they quit future determinations as to whether the Section 4(a)(1) of FCLAA contains the smoking, they can greatly reduce serious textual statements should be revised by nine new textual warning statements risks to their health. Again, that rulemaking. that, when combined with a graphic important message would be lost if we (Comment 124) A few comments also image, comprise the required warning. were to use just one of the suggested suggested that when FDA initiates a Congress did not include an attribution broad statements. new rulemaking to establish its next set to the Surgeon General in the new (Comment 122) One comment stated of graphic warnings, the Agency should textual warning statements, as it has that the ninth warning statement consider adding health warnings that done in past laws on cigarette health provided by Congress in the Tobacco refer to other smoking-related diseases warnings. Accordingly, when we issued Control Act, ‘‘WARNING: Quitting that are not specifically mentioned in our proposed rule and released the 36 smoking now greatly reduces serious this first set of required warnings. proposed required warnings, the textual risks to your health,’’ should appear on (Response) We intend to periodically warning statements did not include a all packages after one of the other eight review the required warnings to assess reference to the Surgeon General. A warning statements. their effectiveness and determine number of comments, including those (Response) We disagree that such a whether the warnings are suffering from from former Surgeons General and change is warranted. As discussed in wear out. During this review, we intend Commissioned Public Health Service section V.B.6 of this document, we have to examine the scientific literature and Officers, questioned why the new health included a reference to a cessation possibly conduct our own research to warnings no longer contain any resource in the required warnings, determine if additional textual warnings attribution to the ‘‘Surgeon General.’’ A which we conclude is more appropriate about the scientifically documented summary of the comments and our than including the ninth warning negative health consequences of response regarding this issue is statement in all the required warnings. smoking are appropriate. included in the following paragraphs. (Comment 123) Many comments (Comment 125) One comment (Comment 127) The comments noted suggested that FDA add additional suggested that FDA utilize different that, since Surgeon General Luther warning statements to state that warnings with featured messages Terry’s 1964 report highlighting the cigarette smoking may increase the risk targeted to specific audiences based on adverse health effects of tobacco use, the of other diseases such as bladder cancer, their different attitudes and beliefs. As Office of the Surgeon General has been impotence, blindness, or COPD. One an example, this comment pointed to inextricably linked to smoking comment stated that medical studies the Canadian health warning directed at prevention and that the reduction in have shown that women who smoke a young males, which stresses that smoking rates since the initial report pack of cigarettes a day double the risk tobacco can make the smoker impotent and the advent of the first Surgeon of orofacial cleft birth defects in their (Ref. 55). General’s warning is due to the public children, and suggested that a warning (Response) We conclude that the nine confidence associated with the Surgeon be added to include this risk and textual statements required by Congress General’s recommendations. In pictures of children with this birth in section 4(a)(1) of FCLAA are addition, they claimed that the new defect (citing, e.g., Ref. 58). One appropriate. In addition, we have warnings would be less effective comment also suggested that the selected color graphics to accompany without the Surgeon General attribution. required warnings indicate that smoking the new warning statements that use a Two other comments also suggested that may increase the risk of breast cancer. variety of different fonts, typography, FDA include ‘‘the federal government Another comment suggested including and layouts; depict a variety of human logo’’ on the health warnings to messages about short-term effects of subjects; and use a variety of styles, communicate that the Department of smoking, such as nutritional including photographic and graphic Health and Human Services (HHS) deficiencies. illustrations. The required warnings will endorses the health message. Another (Response) We decline to add reach a wide variety of audiences comment from a public health advocacy additional warning statements, as including youth, young adult, and adult group suggested that the warning suggested in these comments. At this smokers and nonsmokers. For statements add a reference to FDA and/ point, we have determined the nine information on FDA’s selection of or the U.S. Government to legitimize the textual statements mandated by images, see section III of this document. warnings. In contrast, one comment Congress in section 4(a)(1) of FCLAA As previously stated, we intend to stated that it did not support continued appropriately communicate major monitor the effects of these required use of the Surgeon General attribution, health risks of smoking. As stated warnings once they are put into use. If but if FDA decides to include the previously, we intend to monitor the our monitoring finds that the messages attribution, it should be placed on the effects of these required warnings once are not reaching an appropriately broad side of the package where it does not they are put into use. We will conduct population and that targeted messages detract from the new health warnings. research and keep abreast of scientific would be more effective, we will (Response) We agree with comments developments regarding the efficacy of consider revising the textual statements highlighting the benefits of the Surgeon various required warnings and the types in a future rulemaking. General’s work in the area of smoking and elements of various warnings that (Comment 126) One comment prevention, but we decline to add the improve efficacy. We intend to use the suggested that FDA require a standard ‘‘Surgeon General’’ attribution to the

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required warnings at this time. Congress length and font size of the existing portion of the required warnings is did not include an attribution to the warnings contribute to their translated accurately so that the message Surgeon General as it has done in the ineffectiveness, and larger font sizes is appropriately communicated to past. In addition, there is inconsistency enhance the noticeability of cigarette foreign language speakers. As indicated among the limited scientific literature as warnings (75 FR 69524 at 69530 and in the NPRM, we included Spanish to whether the attribution of health 69534; Ref. 40 at 30–31). Therefore, language translations in recognition of warnings to government sources given the inconsistency in the available the fact that Spanish is the foreign enhances their credibility (see, e.g., research and the potential tradeoffs language most commonly used for Refs. 42, 36, 57, and 59). Attribution to associated with including a government cigarette advertisements in the United a government resource may increase source attribution in the required States (75 FR 69524 at 69537 through believability of the information; warnings, we conclude that there is 69538). We also will work with any however, if the government is generally insufficient evidence to support advertiser who plans to advertise disliked or mistrusted, a government addition of an attribution at this time. cigarettes in any non-English language source attribution may result in We will continue to work in publication, or who plans to utilize a rejection of the health warning (Ref. 11). partnership with other components non-English advertisement in an One 1997 study found that the within HHS to educate consumers about English-language publication in attribution to a government source, the risks of smoking. FDA and others accordance with § 1141.10(b)(2)(ii). including the U.S. Surgeon General, did also will continue to conduct research Specifically, upon request, we will increase the credibility and viewers’ regarding the efficacy of required assist advertisers in generating a true intentions to comply with the warnings warnings. If such research indicates that and accurate translation of the textual for cigarettes (Ref. 57). Similarly, in a adding the Surgeon General attribution statements for the nine new required study conducted prior to Israel’s to the cigarette required warnings will warnings for use in advertisements that decision to require new cigarette improve their efficacy, we will consider are subject to § 1141.10(b)(2). warnings on packages, researchers adding a government attribution as part (Comment 129) One comment found that consumers preferred of a future rulemaking to update the expressed concerns that foreign warnings with attribution to a warnings. language translations sometimes can be government source or medical research ‘‘too literal’’ and could inappropriately C. Foreign Language Translations rather than warnings without attribution impact the meaning of the warning (Ref. 59). As we explained in the preamble to statement. However, in a developmental study the proposed rule, consistent with (Response) We are sensitive to this assessing appropriate attributes for new section 4(b) of FCLAA, proposed concern, and the final rule requires that cigarette warnings in Australia, § 1141.10(b)(2) would mandate that the any translation of the required warning researchers found that the mention of textual component of the required statements results in a true and accurate ‘‘government’’ in an attribution warning appear in the English language foreign language version of the warning reminded smokers that the government in cigarette advertisements with two statements. As stated in the previous collects tax revenue from cigarettes and exceptions. First, per proposed response, we will assist any advertiser led smokers to challenge the sincerity of § 1141.10(b)(2)(i), if an advertisement who plans to advertise cigarettes with a the government in issuing cigarette appears in a non-English language foreign language translation of the health warnings (Ref. 48). Similarly, publication, the textual portion of the required warnings. researchers for the European required warning would need to appear (Comment 130) One comment stated Commission in the European Union in the predominant language of the that all cigarette advertisements in looked at respondents’ reactions to three publication. Second, per proposed predominantly Spanish speaking areas, potential attributions for cigarette § 1141.10(b)(2)(ii), if an advertisement is such as Puerto Rico, and in Spanish warnings: (1) Government/regulatory in an English language publication but language publications should include bodies; (2) health authorities/cancer the advertisement itself is presented in warnings in Spanish. Another comment charities; and (3) tobacco industry (Ref. a language other than English, the recommended that the required 42). They found smokers did not textual portion of the required warning warnings in advertisements be in the respond well to regulatory bodies as a would need to be presented in the same language of the publication or potential source for cigarette warning foreign language principally used in the advertisement. messages, believing that government advertisement. To accommodate the (Response) We agree in certain bodies did not care about their smoking potential need for Spanish language circumstances. As stated in the behavior or were motivated by self- translations of the textual warning proposed rule and required in interest (Id.). statements, we included Spanish § 1141.10(b)(2), any advertisement that Moreover, even though the 1997 study translations with the proposed rule. We appears in a Spanish language did find benefits associated with received several comments regarding publication must present the textual government source attribution, foreign language translations in portion of the required warning in researchers also noted the potential advertisements and one comment Spanish (see § 1141.10(b)(2)(i)). In trade-offs associated with government requesting the use of foreign language addition, for advertisements in English attribution (Ref. 57). They noted the translations on packages. We have language publications, if the surface area restrictions associated with summarized and responded to these advertisement itself is presented in warnings and that the amount of comments in the following paragraphs. Spanish, the required warning in the information that one can give without (Comment 128) One comment advertisement also must be in Spanish losing readers is limited (Id.). They also indicated that the submitter was pleased (see § 1141.10(b)(2)(ii)). However, if an noted that the addition of attribution to see Spanish translations of the English language publication that information may require the use of warnings, but asked that FDA continue includes English language smaller font size, which may impact to work with as many languages as advertisements is sold in predominantly legibility and noticeability of the possible. Spanish speaking areas, the textual warning (Id.). In fact, as we noted in the (Response) We understand the component of the required warnings preamble to the proposed rule, the importance of ensuring that the textual will still be required to appear in

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English, as specified by section 4 of and the addition of information States, including all exported cigarette FCLAA. regarding a cessation resource, are packages. The comment said that it We conclude that these requirements included for the required warnings in would be unconscionable for FDA to will appropriately ensure that the target this final rule. In addition, we are protect residents in the United States audience of any advertisement is able to requiring a reference to 1–800–QUIT– and not the rest of the world when they read and understand both the NOW as part of the required warnings are smoking U.S.-made products. promotional content of the in accordance with section 906(d) of the According to this comment, cigarettes advertisement and the important FD&C Act as appropriate for the that are being exported are essentially warning information. protection of the public health. bought in the United States and these (Comment 131) One comment products are under the FDA’s B. Description of Final Regulations and requested that the required warnings on jurisdiction. all cigarette packages exported to Puerto Responses to Comments (Response) We disagree that it is Rico and Latin America be in Spanish. 1. Section 1141.1—Scope appropriate to impose a requirement (Response) We decline to adopt this In the proposed rule, proposed that cigarettes that are manufactured in request. Section 4(b)(2) of FCLAA and § 1141.1 set forth the scope of the the United States for export bear a § 1141.10(b)(2) require translation of proposed regulations. In particular, required warning. Section 4(a) of required warnings for certain proposed § 1141.1(b) limited the FCLAA applies to cigarettes packages advertisements only. Neither FCLAA applicability of the proposed that are ‘‘for sale or distribution within nor the Tobacco Control Act requires requirements by clarifying that they the United States.’’ Section 12 of foreign language warnings on cigarette would not apply to manufacturers or FCLAA provides: packages sold or distributed within the distributors of cigarettes that do not Packages of cigarettes manufactured, United States, including within the manufacture, package, or import imported, or packaged (1) for export from the Commonwealth of Puerto Rico. cigarettes for sale or distribution in the Unites States or (2) for delivery to a vessel Furthermore, with limited exceptions, or aircraft, as supplies, for consumption United States. Proposed § 1141(c) FCLAA does not apply to packages of beyond the jurisdiction of the internal described situations where a cigarette cigarettes for export from the United revenue laws of the Untied States shall be retailer would not be in violation of the States. exempt from the requirements of this Act, but proposed rule for displaying or selling such exemptions shall not apply to cigarettes V. Description of the Final Rule cigarette packages that do not comply manufactured, imported, or packaged for sale with the rule, so long as certain or distribution to members or units of the A. Overview of the Final Rule conditions were met (75 FR 69524 at Armed Forces of the United States located This final rule adds new part 1141 to 69535). We received several comments outside of the United States. Title 21 of the Code of Federal regarding the scope of the regulation, (15 U.S.C. 1340). In addition, many Regulations, requiring new warnings on which we have summarized and other countries impose their own cigarette packages and in cigarette responded to in the following warning requirements on cigarette advertisements. These new required paragraphs. packages sold in those countries. warnings consist of the nine textual (Comment 132) One comment (Comment 134) One comment warning statements set forth in section requested that all imported cigarettes requested that FDA exercise 201 of the Tobacco Control Act and tobacco products have required enforcement discretion for retailers and accompanied by color graphic images warnings to come into U.S. ports and be distributors selling cigarettes that do not depicting the negative health sold in the United States and its bear a specified warning label because consequences of smoking. We have territories, including Puerto Rico. retailers do not control the labeling of selected nine images, such that each (Response) We agree that imported the products supplied by manufacturers. required warning consists of one of the cigarette packages must bear a required The comment claimed that if a product nine textual warning statements and an warning in accordance with section 4 of is provided by a licensed supplier, and accompanying color graphic. FCLAA and part 1141. Section 1141.10 not altered by the distributor, the As required by section 201 of the provides that it is unlawful for any distributor should likewise be relieved Tobacco Control Act, the rule requires person to import for sale or distribution of liability. the new warnings to appear within the United States any cigarettes (Response) FCLAA provides a very prominently on cigarette packages and the package of which fails to bear one limited exemption for retailers and we in advertisements, occupying at least 50 of the required warnings on both the do not agree that it is appropriate to percent of the area of the front and rear front and rear panels. Section 1141.3 broaden the exemption to distributors. panels of cigarette packages and the top defines United States to include Nor do we agree that it is appropriate to 20 percent of the area of advertisements. specified U.S. territories, including adopt a broad enforcement discretion We also have exercised our authority Puerto Rico. In addition, as explained in policy for retailers and distributors. By under sections 201 and 202 of the section V.B.2 of this document, we are choosing to distribute and sell Tobacco Control Act, which allow FDA revising the definition of importer to cigarettes, distributors are under an to adjust the type size, text, and format clarify that the term importer includes obligation to make sure that the of the textual warning statements. For any person who imports any cigarette, products they receive from example, under section 4(d) of FCLAA regardless of where it was manufacturers, importers, and other (as amended by section 201 of the manufactured. With respect to whether distributors and subsequently distribute Tobacco Control Act), FDA may adjust other tobacco products should have or sell comply with the law, including the type size, text, and format as we required warnings, we have determined checking to see whether the packages determine appropriate so that both the that issue is outside the scope of this include a required warning on the front textual warning statements and the rulemaking. and rear panel. Retailers, however, are accompanying graphics are clear, (Comment 133) One comment not in violation if they display or sell a conspicuous, legible, and appear within supported the imposition of the cigarette package that includes a health the specified area. Such adjustments, required warnings on all cigarette warning, even if it is not one of the nine including adjustments to the type size packages manufactured in the United required warnings, as long as other

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statutory requirements are met (see 15 distributors for labeling or advertising in As explained in the preamble to the U.S.C. 1333(a)(4)). The preamble to the specific situations. This comment proposed rule, proposed § 1141.3 proposed rule made clear that contended that the Tobacco Control Act defined ‘‘importer,’’ for purposes of part manufacturers, importers, and provides specific situations in which 1141, as any person who introduces into distributors have the primary retailers should not be held liable for commerce any cigarette that: (1) Was not responsibility for ensuring that the labeling or advertising and those manufactured in the United States and required warnings on cigarette packages situations are not recognized in the (2) is intended for sale or distribution to comply with all the provisions of part reissued 1996 rule. consumers in the United States. 1141. (Response) Section 201 of the Tobacco Proposed § 1141.3 defined ‘‘retailer’’ as (Comment 135) One comment Control Act, amending section 4 of any person who sells cigarettes to expressed concern regarding the FCLAA to require graphic warnings, individuals for personal consumption, exemption of retailers from an does contain a specific exemption for or who operates a facility where obligation to ensure packages depict retailers in certain circumstances, and vending machines or self-service required warnings. This comment proposed § 1141.1(c) and (d) recognized displays of cigarettes are permitted (75 claimed that the exemption hampers this exemption. Section 102 of the FR 69524 at 69536). enforcement, because an inspector Tobacco Control Act required FDA to (Comment 138) One comment asked needs to be able to seize noncompliant reissue the 1996 Regulations Restricting that FDA expand the definition of packaging at retail. the Sale and Distribution of Cigarettes importer to include persons who (Response) We decline to revise the and Smokeless Tobacco to Protect introduce into commerce cigarettes language of proposed § 1141.1(c). As we Children and Adolescents (61 FR 44396, manufactured in the United States, explained in the preamble to the August 28, 1996) with certain specified exported from the United States, and proposed rule, the limited retailer exceptions. We have complied with this subsequently imported. According to exemption is in accordance with section requirement (75 FR 13225). However, this comment, legislation in 2000 4(a)(4) of FCLAA. The exemption for section 102 of the Tobacco Control Act substantially curtailed this practice, but retailers is limited to situations where did not specify that the reissued 1996 it is still possible. the cigarette package contains a health rule contain an exemption for retailers (Response) We agree that any person warning, is supplied to the retailer by a or distributors. Consequently, this who introduces into commerce license- or permit-holding tobacco graphic warning rulemaking did not cigarettes that were imported into the product manufacturer, importer, or propose any revisions to the reissued United States, regardless of where those distributor, and is not altered by the 1996 rule (currently codified at 21 CFR cigarettes were manufactured, should be retailer in a way that is material to the part 1140). considered an importer. We are revising requirements of section 4(a) of FCLAA. (Comment 137) Multiple comments the definition of importer to clarify this We note, however, that § 1141.1(c) advocated for the placement of graphic point. describes situations where a retailer is warnings on all tobacco products, (Comment 139) With respect to the not considered in violation of part 1141; including smokeless tobacco products. definition of retailer, one comment this exemption does not apply to (Response) We decline to require requested that FDA revise the definition manufacturers, importers, or warnings on other tobacco products in to clarify that Internet sellers are distributors that provide retailers with this rulemaking. In section 4(d) of included in this definition. The noncompliant cigarette packages. Thus, FCLAA, Congress directed FDA to issue comment noted that it appears the although a retailer would not be held regulations to require color graphic retailer definition is broad enough to liable for selling or offering for sale a images to accompany the warnings cover Internet sellers, but clarification cigarette package that is not in full statements required by section 4(a)(1) of would avoid any arguments to the compliance with the requirements of FCLAA. This section of FCLAA requires contrary. part 1141, so long as the retailer fits that the statements be included on (Response) We have determined that within the exemption set forth in cigarette advertisements and cigarette revisions to the definition of retailer are § 1141.1(c), the manufacturer, importer, packages. While we may be able to not needed. The definition is clear that or distributor that provided the require warnings on other tobacco any person, including an Internet seller, noncompliant packages would be liable products under other authority, such who sells cigarettes to individuals for for violating FCLAA and these action is outside the scope of this personal consumption is a retailer. The regulations. Furthermore, the rulemaking. comment provided no examples of misbranding provisions in § 1141.14 2. Section 1141.3—Definitions possible arguments for why an Internet apply to the cigarettes themselves. seller would not meet the definition of Therefore, if we discover misbranded Proposed § 1141.3 included retailer and provided no alternate cigarette packages in a retail definitions for the following terms: language for the definition. It may be • establishment, but the retailer fits Cigarette possible that an Internet seller would • Commerce within the exemption set forth in • not be considered a retailer because it is § 1141.1(c), we could still initiate a Distributor • Front panel and rear panel not selling cigarettes to individuals for seizure action under section 304 of the • Importer personal consumption. In that case, FD&C Act (21 U.S.C. 334). • Manufacturer however, the Internet seller would (Comment 136) One comment • Package likely meet the definition of distributor requested that FDA revise its 2010 • Person and, if so, would be responsible for Regulations Restricting the Sale and • Required warning complying with all responsibilities of Distribution of Cigarettes and Smokeless • Retailer distributors under part 1141 and section Tobacco to Protect Children and • United States 4 of FCLAA. Adolescents (75 FR 13225, March 19, We received only a few comments 2010) (‘‘reissued 1996 rule’’) to ensure regarding definitions described in the 3. Section 1141.10—Required Warnings that the Agency does not exceed the proposed rule. In light of these The Tobacco Control Act directs FDA scope of the Tobacco Control Act by comments, we are revising the to require that color graphic images imposing liability on retailers and definition of ‘‘importer.’’ depicting the negative health

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consequences of smoking accompany Spanish’’ and ‘‘Cigarette Required NPRM (75 FR 69524 at 69538), proposed each of the textual warning statements Warnings—Other Foreign Language § 1141.10(b)(4) would have required that must be randomly displayed on Advertisements’’). regulated entities to obtain color cigarette packages (i.e., in each 12- Section 1141.10(a) sets forth the graphics for foreign language required month period, all of the different requirement specific to cigarette warnings, other than Spanish language warnings must appear in as equal a packages, explaining that the new warnings, from the electronic files number of times as is possible on each required warning must comprise at least contained in ‘‘Cigarette Required brand of the product and be randomly the top 50 percent of the front and rear Warnings—Other Foreign Language distributed in all areas of the United panels of the package, except for cartons Advertisements,’’ and regulated entities States in which the product is marketed) where the warnings shall comprise 50 would have to insert a true and accurate and rotated quarterly in cigarette percent of the left side of the front and foreign language translation of the advertisements under FCLAA. rear panels. This regulation implements textual warning required by FCLAA into Accordingly, in proposed § 1141.10, we section 4(a)(2) of FCLAA and is in line the electronic file to generate the proposed that cigarette packages and with the provisions of the Framework required warning (as explained advertisements contain such a Convention on Tobacco Control (FCTC) previously, these electronic files are combination graphic-textual warning. (Ref. 60). Section 1141.10(a)(3) now contained in the document entitled Proposed § 1141.10 provided that the specifically provides that the ‘‘required ‘‘Cigarette Required Warnings’’). While warnings required by this section be warning shall appear directly on the the electronic file obtained from obtained from two documents entitled package and shall be clearly visible ‘‘Cigarette Required Warnings’’ contains ‘‘Cigarette Required Warnings—English underneath the cellophane or other some of the elements required by and Spanish’’ and ‘‘Cigarette Required clear wrapping.’’ Section 1141.10(b) sets FCLAA (e.g., a rectangular border to Warnings—Other Foreign Language forth the requirements for enclose the required warnings and the Advertisements.’’ ‘‘Cigarette Required advertisements, including the color graphic to accompany the label Warnings—English and Spanish’’ was requirement that the warnings comprise statement), the textual warning proposed to contain the required at least 20 percent of the area of the statement that regulated entities insert warnings that must be included on all advertisements. Section 1141.10(c) into the electronic file in accordance cigarette packages, and in cigarette provides that the required warnings with § 1141.10(b)(4) must comply with advertisements in which the text of the shall be indelibly printed on or the requirements of section 4(b)(2) of required warning must be set forth in permanently affixed to the package or FCLAA. This section provides, among the English language or the Spanish advertisement. For the final rule, we other things, format specifications language. ‘‘Cigarette Required have deleted the language from related to the textual warning Warnings—Other Foreign Language § 1141.10(a)(2) and (b)(3) that specified statements in cigarette advertising, Advertisements’’ was proposed to that the electronic images must be including required type sizes and color contain the electronic files that were to adapted as necessary to meet the specifications (i.e., the text of the label be used to generate the required requirements of section 4 of FCLAA and statement shall be black if the warnings for advertisements in which part 1141. As explained in the NPRM background is white and white if the the text of the required warning must be (75 FR 69524 at 69536 through 69538), background is black), and requires that set forth in a foreign language (other this language was used to indicate that the statements appear in conspicuous than Spanish). regulated entities should modify the and legible type. The material that was proposed to be size of the required warnings to ensure contained in the two documents entitled they are the required size and occupy In addition, we wish to clarify our ‘‘Cigarette Required Warnings—English the required area of the cigarette intent regarding whether the same and Spanish’’ and ‘‘Cigarette Required package or advertisement. However, warning statement must appear on both Warnings—Other Foreign Language § 1141.10(a)(4) and (b)(5) set forth the the front and rear panels of an Advertisements’’ is now contained in a size and placement requirements for individual cigarette package. We believe single document entitled ‘‘Cigarette required warnings on packages and that section 4(a)(1) of FCLAA is Required Warnings.’’ We have provided advertisements, so this language in ambiguous as to whether it mandates this information in a single document proposed § 1141.10(a)(2) and (b)(3) was the use of the same required warning on because each of the electronic files for not necessary. In addition, both the front and rear panels of an use in advertisements contained in § 1141.10(a)(1) and (b)(1) make clear individual cigarette package or allows ‘‘Cigarette Required Warnings’’ allows that the required warnings on cigarette two different required warnings to be users to select an English or Spanish packages and in cigarette used, one on the front panel and the textual warning statement or to remove advertisements must be ‘‘in accordance other on the rear panel. We believe that the textual warning statement and insert with section 4 of the Federal Cigarette the latter interpretation is reasonable. It a true and accurate foreign language Labeling and Advertising Act.’’ is consistent with Congress’ intent that (other than Spanish) translation of the We also have made minimal changes all of the required warnings, each of warning statement into the file. It is thus to § 1141.10(b)(4), which used similar which conveys somewhat different unnecessary to provide separate language. Specifically, proposed health information, are required to be documents with electronic files for § 1141.10(b)(4) indicated that the displayed in the marketplace at the English and Spanish language required warnings for foreign language same time (see section 4(c)(1) and (c)(3) advertisements and for advertisements advertisements (other than Spanish) of FCLAA). While it is possible that two in which the text of the required must be adapted as necessary to meet copies of the same statement on a single warning must be set forth in a foreign the requirements of section 4 of FCLAA package might increase the likelihood of language (other than Spanish). Section and part 1141. For clarity, we have the warning being noticed and 1141.10 has been updated to reference modified this language to indicate that remembered, we also note that different this single document, ‘‘Cigarette the textual warning statement that is statements on a single package could Required Warnings,’’ rather than the inserted into the electronic images must lead to greater consumer exposure as two proposed documents (‘‘Cigarette comply with the requirements of section well as delay the wear out of the Required Warnings—English and 4(b)(2) of FCLAA. As explained in the required warnings. Proposed

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§ 1141.10(a)(1), along with the requirement without committee misunderstand or underestimate the description of this provision in the testimony or other fact-finding as to health risks of smoking. The new size preamble to the proposed rule (75 FR whether a smaller-sized warning would and placement requirements are needed 69524 at 69536), however, implied that be effective. The comments asserted that to increase the salience of cigarette the same required warning must appear the current size and placement of the health warnings, which are now on both the front and the back of the warnings on cigarette packages and considered ‘‘invisible,’’ in order to package. Therefore, we are revising advertising have contributed to educate the public about the health risks § 1141.10(a)(1) to state, ‘‘It shall be ‘‘complete awareness levels of the of smoking, which in turn, can unlawful for any person to manufacture, dangers of cigarettes.’’ positively impact smoking intentions package, sell, offer to sell, distribute, or (Response) We disagree. As we stated and behaviors (Ref. 3 at p. 291). import * * * any cigarettes the package in the preamble to the proposed rule, (Comment 142) Some comments of which fails to bear * * * one of the our assessment of the literature and our suggested that the regulation include a required warnings on the front and the experience as a public health agency font size requirement. rear panels.’’ supports the requirement that the new (Response) We note that the proposal We received comments regarding the warnings comprise the top 50 percent of included a requirement related to font format of required warnings on packages the area of each of the front and rear size and this is retained in the final rule. and advertisements, the applicability of panels of cigarette packages and the top The final rule mandates that the the requirements to cigarette cartons, 20 percent of the area of cigarette required warnings be accurately and the need for the warnings to remain advertisements in the United States (75 reproduced from the document clearly visible and permanently affixed FR 69524 at 69533). For example, incorporated by reference entitled to packages. A summary of these researchers have found that larger ‘‘Cigarette Required Warnings.’’ The comments and our responses is graphic warnings are likely to have the required font style and font size already provided in the following paragraphs. greatest impact and that ‘‘larger (label) will be included in the options within (Comment 140) Many comments, size means higher visibility and better the downloadable files that allow the including those from health institutions, ability to compete with other package user to select English and Spanish nonprofit organizations, academics, and elements’’ (Ref. 40 at p. 30). Smokers are language warning statements. consumers, agreed that the significant more likely to recall larger warnings, For advertisements in foreign enhancements to the cigarette health and have been found to correlate the languages other than Spanish, warnings required by § 1141.10 will size of the warning with the seriousness companies must comply with the font make them considerably more of the risk (Ref. 61). One Canadian study size requirements in section 4(b)(2) of noticeable and memorable than found that smokers judged warnings FCLAA and any format requirements warnings that currently appear on that covered 80 percent of the package included in the document incorporated cigarette packages and in cigarette to be most effective (Ref. 11). In a New by reference (see section V.B.4 of this advertisements. However, many Zealand study gauging responses to document). In all situations, the textual comments also noted that the FCTC different sized graphic health warnings statements must be conspicuous and Article 11 Guidelines urge parties to (one sized 50 percent of the front of the legible as required by section 4 of cover as much of the principal display pack, and another sized 30 percent of FCLAA. areas as possible and that evidence the front of the pack), participants (Comment 143) One comment from an suggests that warnings larger than 50 strongly preferred the larger sized industry group took issue with FDA’s percent of the principal display areas warning (Ref. 40 at p. 31). Participants authority to require the new graphic may be even more effective (citing Ref. felt that the larger sized warning was warnings on cigarette cartons, claiming 41). The comments noted that more prominent, more likely to stand that Congress’ intent was to require the researchers also have found that out from product branding, and that new graphic warnings on individual smokers correlate the size of the some of the messages on the front of the cigarette packs only, not cartons. The warning label to the importance of the pack remained visible when the pack submitter recommended that FDA message—the larger the message, the was open (Id. at p. 30). The 50 percent expressly exempt cartons from this greater magnitude of the risk (citing Ref. requirement also is consistent with the requirement. 61). Accordingly, these comments FCTC (i.e., the required warnings (Response) We disagree with this requested that FDA consider increasing should occupy 50 percent or more of the comment. FCLAA defines the term the size of the graphic warnings such principal display areas of packages), ‘‘package’’ to mean a ‘‘pack, box, carton, that they occupy more than 50 percent which was among the substantial or container of any kind in which of the front and rear panels of cigarette evidence considered by Congress when cigarettes are offered for sale, sold, or packages. enacting the Tobacco Control Act (FCTC otherwise distributed to consumers.’’ (Response) We decline to revise the art. 11.1(b)). ‘‘Congress also informed its (section 3(4) of FCLAA (15 U.S.C. 50 percent area requirement at this time. warning requirements by looking at the 1332(4)) (emphasis added)). Similarly, We have currently determined that this use of a nearly identical warning section 900(13) of the FD&C Act defines requirement is sufficient to achieve our requirement in Canada.’’ the term ‘‘package’’ to mean a ‘‘pack, goals, and this requirement is consistent Commonwealth Brands v. United States, box, carton, or container of any kind or, with the specification set forth by 678 F. Supp. 2d 512, 531 (W.D. Ky. if no other container, any wrapping Congress in section 4(a)(2) of FCLAA. 2010), appeal pending sub nom., (including cellophane), in which a (Comment 141) A few comments Discount Tobacco City & Lottery, Inc. v. tobacco product is offered for sale, sold, expressed the belief that there was no United States, Nos. 10–5234 & 10–5235 or otherwise distributed to consumers.’’ adequate justification for the amount of (6th Cir.). (21 U.S.C. 387(13) (emphasis added)). space mandated for the new required In addition, as described more fully in Given these definitions, it is clear that warnings (i.e., 50 percent of the front section II.C of this document, the when Congress decided to require and back panels of packages and the top existing warnings have not been graphic warnings that occupy 50 20 percent of the area of effective in communicating the health percent of the front and back panels of advertisements). One comment noted risks of smoking, resulting in significant cigarette ‘‘packages,’’ it intended for this that Congress enacted the 50 percent portions of the population that requirement to apply to both individual

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packs and cartons. Therefore, (Comment 146) Proposed warnings on papers or filters under § 1141.10(a)(4) continues to mandate § 1141.10(a)(5) provided that the other authority, that is outside the scope that the required warnings must ‘‘required warning shall be positioned of this rulemaking. constitute 50 percent of the left side of such that the text of the required (Comment 149) One comment the front and rear panels of cigarette warning and the other information on suggested that FDA amend the cartons. that panel of the package have the same regulation to prohibit distributors from (Comment 144) One comment orientation.’’ One comment expressed obscuring any portion of the warning recommended that FDA require the nine concern that this provision could be label with revenue stamps. new textual warning statements, problematic if a manufacturer places the (Response) As written, the proposed included in section 4(a) of FCLAA, to be brand name and other information rule would prohibit distributors from displayed in the same manner as the vertically on the front and/or back of the obscuring any portion of the required display of the existing warnings, cigarette package. The comment warning with revenue stamps. Cigarette because that format has contributed to believed that this provision would packages must comply with the the public being fully informed about require the warning, or the text of the requirement in § 1141.10(a)(3) that the the health risks of smoking. warning, to appear sideways on the new required warnings be clearly (Response) We disagree. First, as cigarette package. visible. Moreover, in order for the explained in section II.C of this (Response) The intent of this required warnings to appear document, the public is not adequately provision is to ensure that the textual conspicuously and legibly as mandated informed about the health risks of statement in the required warning and by section 4 of FCLAA, the warnings smoking and frequently underestimates other information on the front and rear must not be obscured. Thus, if the those risks. Second, Congress mandated panels of the package have the same placement of revenue stamps by a that the format of the new health orientation. As explained in the NPRM, distributor causes the required warnings warnings change from the small this will in turn ensure that the to not be clearly visible or legible, the distributor would be in violation of warning on the side panel of the pack, warnings are noticed and read by these regulations. Therefore, we do not covering only 4 percent of the pack, to consumers that are reading the other agree that any revisions to § 1141.10 are health warnings that ‘‘comprise the top information found on the package (75 FR 69524 at 69537). Therefore, in the necessary. 50 percent of the front and rear panels (Comment 150) One comment of the package’’ and ‘‘at least 20 percent unusual circumstance where a manufacturer chooses to place its brand suggested that FDA require the use of of the area of the advertisement.’’ (15 onserts affixed to cigarette packages in U.S.C. 1333(a)(2) and (b)(2)). This is name or other information such that viewers do not read along the horizontal addition to the new required warnings, consistent with the FCTC (FCTC art. axis (i.e., from left to right) to read this stating that they would enhance the 11.1(b)). Therefore, we decline to information, the manufacturer must effectiveness of the new health change the format of the required place the required warning in the same warnings. Similarly, another comment warnings from that included in the orientation. stated that, in addition to the new proposed rule. (Comment 147) Two comments required warnings, FDA should require (Comment 145) One comment suggested that the FDA require health that cigarette packages contain inserts suggested that the required warnings on warnings on 100 percent of only the with animated warnings containing cigarette advertisements cover at least front or the rear panel of the cigarette supplementary or distinct warning 50 percent of the advertisement’s package. messages to enhance the overall principal surface and match the (Response) We disagree. First, section warning impression and further engage advertisement’s primary language. 4(a)(2) of FCLAA specifically requires individuals. (Response) As stated in the preamble that the cigarette health warnings (Response) A requirement to add to the proposed rule and as required by ‘‘comprise the top 50 percent of the onserts or inserts is beyond the scope of section 4 of FCLAA, § 1141.10(b)(5) front and rear panels of the package.’’ this rulemaking and, therefore, we mandates that the required warnings Second, Article 11 of the FCTC states decline to require them here. comprise at least the top 20 percent of that the health warnings ‘‘should be (Comment 151) One comment stated the area of the advertisement. Section 4 50% or more of the principal display that there is no empirical basis for of FCLAA also requires that the warning areas but shall be no less than 30% of concluding that the nine warning statement appear in conspicuous and the principal display areas’’ (Ref. 60). statements required under section 4 of legible type. At this time, we conclude FDA’s new warnings implement FCLAA should be written in large text these requirements are sufficient to Congress’ directive and are consistent on the front and back panels of packages ensure that the required warnings are with the FCTC. in order to convey the health risk appropriately clear, conspicuous, and (Comment 148) A few comments information. legible by consumers. suggested that FDA require health (Response) We disagree with this Moreover, as stated in the preamble to warning statements on cigarette papers comment and conclude that there is a the proposed rule and as indicated in and/or filters. sufficient empirical basis for concluding section IV.C of this document, while the (Response) We decline to require that the warning statements should be textual portion of the required warning warnings on cigarette papers and/or in large text that is conspicuous and in a cigarette advertisement must filters. In section 4(d) of FCLAA, legible. Research has shown that generally be in English, if an Congress directed FDA to issue increasing the salience of warnings advertisement is presented in a language regulations to require color graphic increases the likelihood of consumers other than English, the textual portion images to accompany the warnings reading warnings and that the salience of the required warning must be statements required by section 4(a)(1) of of a visual warning can be enhanced by presented in the language principally FCLAA. FCLAA requires that the using large, bold print (Ref. 62). In used in the advertisement (see statements be included on addition, after Australia changed their § 1141.10(b)(2)(ii)). Therefore, we have advertisements and cigarette packages, health warnings to six rotated textual determined that modifications to the not individual cigarette papers or filters. warnings with a cessation resource and codified text are not necessary. While we may be able to require additional explanatory text in 1995,

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researchers found that the increased text individual cigarette packs. This color of the warnings. In addition, size was the most salient feature (Ref. comment claimed that the publication Congress provided specific font size 63). Furthermore, the IOM Report, of health warning messages in multiple requirements for the cigarette warnings which provides a summary of the media will not foster awareness of the (while also affording FDA the authority available research on the efficacy of information (because it is already to initiate a rulemaking proceeding to graphic warnings, found that larger, known) or belief in it (because it is adjust the format, type sizes, and certain graphic health warnings (including large already believed). other aspects of the health warnings text and a large graphic) would promote (Response) We disagree. As explained under sections 4(b)(4) and (d) of FCLAA greater public knowledge of the health in section II.D of this document, despite and section 202(b) of the Tobacco risks and would help reduce existing warning requirements on Control Act. In contrast, Congress’ consumption of tobacco products (Ref. packages and in advertisements, health warning requirements for 3). The placement of the large text and consumers lack knowledge of the health alcoholic beverages, published at 27 graphic image on the front and back risks and underestimate the health risks U.S.C. 215, do not set forth area, panels of cigarette packages is of smoking. It is critical that the location, and color requirements with as consistent with the FCTC, i.e., that negative health consequences of much specificity. health warnings should occupy 50 cigarette smoking, which is the leading (Comment 155) One comment from an percent or more of the principal display cause of preventable death and disease individual consumer expressed areas of packages (FCTC art. 11.1(b)). in the United States, be clearly, concerns that manufacturers may alter (Comment 152) One comment accurately, and effectively conveyed in their packaging to subvert § 1141.10(c), claimed that the format of the new all advertisements and on all cigarette which mandates that the required required warnings is inconsistent with packages sold or distributed in the warnings on packages and FDA’s drug warning label regime. For United States. advertisements must be irremovable or example, the comment stated that even This is consistent with the permanent. for very severe risks, the drug requirements of FCLAA. As explained (Response) The regulation, as drafted, regulations do not require warning more fully in response to Comment 143, should address the comment’s concern. information to appear in large text or to FCLAA’s requirements apply to Section 1141.10(c) of the final rule, occupy a large portion of the packaging. cigarette packages (including cartons), which is unchanged from what The comment also noted that, in drug and to advertisements generally. appeared in the proposed rule, states advertising, the FDA requires important Further, with its passage of the that the ‘‘required warnings shall be risk information to be included in a Tobacco Control Act, Congress noted indelibly printed on or permanently section of the advertisement entitled the pervasiveness of tobacco advertising affixed to the package or ‘‘Brief Summary.’’ and how it impacts use, especially advertisement.’’ Therefore, regardless of (Response) We have acknowledged promotions directed to attract youths to the type of packaging used by that the warning requirements for tobacco products, and found that manufacturers, all cigarette packages cigarettes are, and should be, different comprehensive advertising restrictions must contain required warnings that are than the warnings for other FDA- will have a positive effect on the irremovable or permanently affixed to regulated products. As we explained in smoking rates of young people (section the cigarette packages. the preamble to the proposed rule, ‘‘(1) 2(15) and 2(25) of the Tobacco Control 4. Section 1141.12—Incorporation by The warning information for cigarettes Act). Therefore, the requirement that the Reference of Required Warnings is different in its applicability than the warnings appear in all advertisements, warning information for other products, regardless of the medium used for the Proposed § 1141.12 proposed that two (2) the disclosure requirements for other advertisement, is also consistent with documents, ‘‘Cigarette Required products have a different purpose than Congress’ intent. Warnings—English and Spanish’’ and the cigarette warnings, and (3) the (Comment 154) One comment noted ‘‘Cigarette Required Warnings—Other mechanisms for exposure to warning that the Federal government warnings Foreign Language Advertisements,’’ be information are different for tobacco on alcoholic beverages are mandated on incorporated by reference in accordance products than for other products FDA packages only, presented in small font, with 5 U.S.C. 552(a) and 1 CFR part 51. regulates’’ (75 FR 69524 at 69539). In and not required on the prominent faces Draft versions of both documents were contrast to medical products regulated of containers or packaging. According to made available in the docket with the by FDA, there is no population that the comment, this suggests that NPRM. cigarettes are medically appropriate for, Congress believes a configuration like We did not receive comments and there is no safe method of using the one for alcoholic beverages also regarding the use of the incorporated by cigarettes; the required warnings for would be sufficient for cigarette reference mechanism provided in 5 these products thus have an inherently warnings, particularly given the more U.S.C. 552(a) and 1 CFR part 51 and the different purpose than medical product widespread use of alcoholic beverages proposed codified language, or warning information. The different in this country. regarding the two draft documents warning schemes that apply to tobacco (Response) We disagree. Congress proposed for incorporation by reference. products versus medical products are clearly intended for the warnings for However, as explained in section V.B.3 necessary to most effectively cigarettes and alcoholic beverages to be of this document, the material that was communicate the health risks for different, as evidenced by the different proposed to be contained in the two tobacco products and for other FDA- statutory schemes that govern the documents entitled ‘‘Cigarette Required regulated products. warning requirements for cigarettes and Warnings—English and Spanish’’ and (Comment 153) One comment alcohol products. For cigarettes, ‘‘Cigarette Required Warnings—Other claimed that FDA did not provide an Congress clearly set out the location of Foreign Language Advertisements’’ is adequate justification for requiring the the health warnings for cigarette now contained in a single document same health warning messages in packages and advertisements, the area of entitled ‘‘Cigarette Required Warnings.’’ multiple media, including print the package or advertisement that must As a result, we have made advertisements, point-of-sale displays, be covered by the warnings and the nonsubstantive changes to the language cartons, and the front and back of requirements for text and background used in § 1141.12 to indicate that we are

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incorporating ‘‘Cigarette Required deemed misbranded if its labeling or 903 of the FD&C Act, ‘‘Misbranded Warnings’’ by reference (rather than advertising is false or misleading in any Tobacco Products,’’ provides other ways ‘‘Cigarette Required Warnings—English particular. Under section 201(n) of the that tobacco products can be and Spanish’’ and ‘‘Cigarette Required FD&C Act (21 U.S.C. 321(n)), in misbranded that extend to tobacco Warnings—Other Foreign Language determining whether something is product labeling as well as package Advertisements’’). In addition, we also misleading, it: ‘‘Shall be taken into labels and advertising. Therefore, in have updated the incorporation by account * * * not only representations addition to complying with the reference document to include the final made or suggested * * * but also the requirements of FCLAA and this rule, electronic files 5 for the required extent to which the labeling or regulated entities must comply with the warnings and to add additional formats advertising fails to reveal facts * * * requirements of section 903 of the FD&C and instructions for regulated entities to material with respect to consequences Act to avoid misbranding their tobacco use to place the required warnings on which may result from the use of the products. various sizes of cigarette packages article to which the labeling or (Comment 157) One comment from a (including cartons) and in different sizes advertising relates * * * under such public health advocacy group stated that and shapes of advertisements, as is conditions of use as are customary or clarifying changes should be made to discussed in more detail in section VI of usual.’’ As explained in the NPRM (75 the language in § 1141.14 to ensure the this document. FR 69524 at 69539), the required regulation accomplishes its intended ‘‘Cigarette Required Warnings,’’ warnings are clearly material with purpose. Specifically, the comment including the electronic files for all of respect to consequences that may result stated that cigarettes can be deemed the required warnings and the from the use of cigarettes. misbranded under the FD&C Act unless instructions for their use, is available Proposed § 1141.14(b) provided that a they meet a number of criteria, and that from a variety of sources. For example, cigarette advertisement or package will not all of the criteria relate to health this material is available on a Web site be deemed to include a brief statement warning requirements. Thus, a regulated located at http://www.fda.gov/ of relevant warnings for the purposes of entity could comply with the warning cigarettewarningfiles. In addition, section 903(a)(8) of the FD&C Act if it requirements, but its cigarette product regulated entities can request a copy of bears one of the required warnings. It could still be deemed misbranded under ‘‘Cigarette Required Warnings’’ by also proposed that a cigarette the FD&C Act if it failed to meet other submitting a request to FDA at the distributed or offered for sale in any criteria in section 903 of the FD&C Act. following e-mail address— State shall be deemed to be misbranded The comment suggested the language in [email protected]—or under section 903(a)(8) of the FD&C Act section § 1141.14 should clarify this by contacting the Center for Tobacco unless the manufacturer, packer, or point. (Response) We agree that cigarettes Products, Food and Drug distributor includes in all can be deemed misbranded under the Administration, Office of Health advertisements and packages issued or FD&C Act for a number of reasons. We Communication and Education, ATTN: caused to be issued by the also agree that, although compliance Cigarette Warning File Requests, 9200 manufacturer, packer, or distributor with the requirements of part 1141 is Corporate Blvd., Rockville, MD 20850, with respect to the cigarette one of the necessary to comply with certain 1–877–CTP–1373. required warnings. We received two comments on the issue, which we have provisions of section 903 of the FD&C 5. Section 1141.14—Misbranding of summarized and responded to in the Act, this does not guarantee that a Cigarettes following paragraphs. cigarette product satisfies all the Proposed § 1141.14(a) provided that a (Comment 156) One comment from a provisions of section 903 of the FD&C tobacco product manufacturer stated Act. However, we do not agree that cigarette shall be deemed to be that FDA should replace the word changes to the codified text at § 1141.14 misbranded unless its labeling and ‘‘labeling’’ with the word ‘‘packages’’ in are necessary, as the text does not advertising bear one of the required § 1141.14(a). The comment indicated indicate that cigarettes will not be warnings. Under section 903(a)(1) and that FDA should avoid using the word deemed misbranded for any reason if (a)(7)(A) of the FD&C Act (21 U.S.C. ‘‘labeling’’ because that term has a they include required warnings, but 387c(a)(1) and (a)(7)(A)), a tobacco broader meaning under the FD&C Act rather that cigarettes will be deemed product, including a cigarette, is than it does under FCLAA, and misbranded if they fail to include therefore its use in the regulation could 5 As described in section VI.A of this document, required warnings. create unnecessary ambiguity. The the final electronic files for the required warnings 6. Section 1141.16—Disclosures are built as Encapsulated PostScript (.eps) files, comment also stated that FCLAA only Regarding Cessation which is a format that is commonly used by requires warnings on cigarette packages professional printers. Because members of the and advertisements. Section 1141.16 of the NPRM public may not have software that can easily view these files, we are placing in the docket Ref. 64, (Response) We agree that the proposed that one or more of the which is composed of .pdf versions of each of the requirements for inclusion of health required warnings include specified formats for each of the English and Spanish warnings set forth in FCLAA apply to information about an appropriate language required warnings, as well as the each package (i.e., pack, box, carton, or smoking cessation resource. As instructions contained in ‘‘Cigarette Required Warnings.’’ We note, however, that these .pdf files container of any kind in which explained in the NPRM, the goal is to do not have the same functionality as the .eps files. cigarettes are offered for sale, sold, or provide a place where smokers and Unlike .pdf files, .eps files have separate layers for otherwise distributed to consumers) and other members of the public can obtain text and images and the use of these layers can be each advertisement of cigarettes. The smoking cessation information from manipulated by users. In addition, .pdf files are not included for foreign language advertisement package warnings required by FCLAA staff trained specifically to help smokers warnings (other than Spanish) because regulated are one part of a product’s ‘‘labeling,’’ as quit by delivering current, unbiased, entities are responsible for generating a true and the term ‘‘labeling’’ encompasses the and evidence-based information, advice, accurate translation of the textual warning package label. We have revised and support. The NPRM identified a statement in the required language for such warnings, and thus the final versions of such § 1141.14(a) to replace the word number of possible alternatives for a warnings are not contained in ‘‘Cigarette Required ‘‘labeling’’ with the word ‘‘packages’’ for cessation resource, including use of an Warnings.’’ clarity. We note, however, that section existing or new quitline or Web site.

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Although we did not include a specific CDC working with the State quitline to a cessation resource would be consistent cessation resource on the proposed ensure staff are adequately trained. If with Article 14 and Article 12 of the images published with the NPRM, we warranted, it could also include more FCTC. In addition, numerous comments proposed that the final rule would serious measures such as CDC working cited evidence from other countries, include one or more required warnings with NCI to re-route calls to another particularly Australia, New Zealand, the containing a cessation resource. We resource. Because the record indicates Netherlands, Brazil, Singapore, and the proposed that the resource must meet that quitlines that are members of the United Kingdom, where adding a specific criteria designed to ensure that Network generally comply with the smoking cessation quitline number to the cessation information, advice, and criteria already, we anticipate that any cigarette warnings significantly support provided are unbiased and measures to bring quitlines into increased calls to the quitline (citing, evidence-based. compliance will be rare. e.g., Refs. 67, 68, 69, 70, 71, 72, and 73). As explained more fully in the a. Rationale and authority for As one comment noted, these results following paragraphs, we have decided, requiring inclusion of a cessation show, consistent with behavior change based on our authority in section 906(d) resource. The NPRM explained that theory, that providing a quitline number of the FD&C Act, to require that all nine reducing the number of Americans who may be a critical component of the required warnings refer to a cessation smoke by increasing the likelihood that required warning that facilitates resource, and we have included this smokers will quit smoking would behavioral action. According to one resource in the nine graphic warnings in provide substantial public health comment from an academic institution, ‘‘Cigarette Required Warnings,’’ which benefits by reducing the life-threatening an evaluation of the impact of including is incorporated by reference (IBR consequences associated with continued a supportive cessation message document) as described in section V.B.4 cigarette use. The NPRM also cited accompanied by quitline numbers and of this document. This final rule studies finding that health warnings are Web-based cessation information in specifies the criteria that will be more effective if they are combined with seven European countries (Denmark, required of any responsible entity cessation-related information. France, Iceland, The Netherlands, providing services through the chosen Consequently, FDA proposed requiring Norway, Poland, and Sweden) found a cessation resource. The resource we information about an appropriate significant increase in quitline call have selected is the existing National smoking cessation resource under volume in all countries except Norway. Network of Tobacco Cessation Quitlines section 906(d) of the FD&C Act as One comment from a submitter (Network), which uses the telephone appropriate for the protection of the representing quitlines stated that it is portal 1–800–QUIT–NOW. This public health (75 FR 69524 at 69540 feasible for the cigarette industry to telephone portal, provided by the through 69541). We received a number include a cessation resource on every National Cancer Institute (NCI), routes of comments regarding our rationale and package of cigarettes, noting that calls to the appropriate State quitline, authority to require a cessation resource approximately 20 nations currently based on the area code of the caller. The on the graphic health warnings, which require a quitline number on their Network includes a designated quitline we summarized and responded to in the tobacco packages and advertisements. run by or on behalf of each of the 50 following paragraphs. Many comments cited statistics that states as well as the District of (Comment 158) A large majority of smokers who use evidence-based Columbia, Puerto Rico, and Guam comments that addressed the issue services of telephone quitlines have a (hereinafter referred to as ‘‘State strongly supported inclusion of a two to three times higher rate of success quitlines’’ or ‘‘State-run quitlines’’).6 We cessation resource on all the required in quitting than smokers making conclude that this resource will provide warnings. These include comments unassisted quit attempts (citing, e.g., the broadest access for smokers from public health advocacy groups, Ref. 66). One comment from a local throughout the United States to medical organizations, academics, State public health agency asserted that unbiased, evidence-based cessation and local public health agencies, and media campaigns and educational information, advice, and support. The representatives of quitlines. The efforts, while effective, still do not reach Centers for Disease Control and comments provided a variety of reasons all smokers. According to this comment, supporting inclusion of a cessation Prevention (CDC) already provides after extensive outreach, about 25 resource on the required warnings. significant support and oversight to percent of smokers in that city had Many comments asserted that a majority these State-run quitlines. Beginning never heard of the quitline being of smokers want to quit, and referring with the effective date of this rule, promoted and 25 percent of smokers smokers to a smoking cessation resource CDC’s cooperative agreements with reported that it is not easy for a person will help them to quit. Some comments State health departments will specify interested in quitting smoking to obtain cited statistics regarding the number of that the State quitlines must meet the information about ways to quit. smokers who actually attempt to quit— Several comments noted that the criteria described in § 1141.16(b) to about 40 percent of smokers try to quit purpose of graphic warnings is to qualify for cessation funding under the in a calendar year—and the very low inform smokers about the risks of cooperative agreement. HHS will percentage of smokers who are smoking and motivate smokers to want monitor the quitlines for compliance successful—95 percent of those who try to quit, but this message will be more with the criteria, and if it determines to quit on their own relapse (citing, e.g., effective if there is information in the that a State quitline does not meet the Ref. 65 and Ref. 66). One comment from graphic warnings on how smokers can criteria, it will take appropriate steps to a State public health agency asserted obtain help quitting. Some comments bring the State quitline into compliance. that smokers contemplating quitting are argued that health warnings should not What is appropriate will depend on the motivated by smoking cessation just inform smokers about the dangers of circumstances of the particular messages to call a State tobacco quitline. tobacco use, but also provide assurance situation. For example, it might involve Many comments argued that that quitting is possible and assistance including a cessation resource is is available. One comment cited 6 Calls to 1–800–QUIT–NOW from U.S. territories that do not currently have a quitline (e.g., the U.S. consistent with the guidelines for research that shocking, fear-arousing Virgin Islands or American Samoa) are routed to a implementing Article 11 of the FCTC. images can be more effective when quitline that is run by NCI. One comment also stated that including combined with encouragement or

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empowering messages (citing, e.g., Ref. smokers will become aware of the the number of calls to the quitlines 74). Another comment from an cessation resource and, consequently, following their appearance on cigarette academic institution claimed that when the increased likelihood that existing packages. For example, in the people perceive that there is a strategy smokers who want to quit will be Netherlands, the number of callers to for them to take positive action to successful. It is also due to the the quitline increased more than reduce the threat in a fear message, fear likelihood that the reference to a threefold after a smoking cessation appeals successfully changed health- smoking cessation resource will message (‘‘Ask for help with smoking related attitudes and behaviors (citing, enhance the effectiveness of the cessation’’) and the national quitline e.g., Refs. 75, 76, 77, and 78). However, warnings required under FCLAA at number were included on cigarette if people do not believe they have an conveying information about the risks to packages (Ref. 72). Similarly, in effective means of avoiding a threat, health from smoking. Australia, the number of calls to the they may suppress thoughts about the As stated in the comments, the quitline nearly doubled, compared with risk, and, as a result, not process the majority of smokers want to quit and the previous 2 years, following the threat information (citing, e.g., Refs. 79, about 40 percent of smokers attempt to introduction of new color graphic 80, and 81). As one comment from an quit each year. In addition, the warnings warnings with a prominent quitline academic institution explained, under required under FCLAA and this number. The increase in call volume fear appraisal theory, a fear regulation convey information and persisted in the following year, although communication message will cause promote greater understanding about it was about 40 percent lower than in aversive anxiety, which individuals will the significant health risks associated the year in which the graphic warnings try to ameliorate through behaviors that with smoking, which will likely lead were first introduced. Although there reduce the perceived threat. This additional smokers to decide that they was a series of mass media campaign comment asserted that the positive want to quit smoking to address these activities that accompanied the new effects of a fear message depend upon risks. Also, as discussed in the graphic warnings, one study concluded the existence of an available coping comments, the vast majority of those it was very unlikely that the mass media option that is perceived to be potentially attempts are unsuccessful. By including campaign alone explained the observed effective at reducing the threat. In a cessation resource on required increase in calls because the addition, comments cited research that warnings, the many smokers who want introduction of the graphic warnings smokers may be more likely to attempt to quit will receive information about a had an independent effect (Ref. 67). In to quit when they know a quitline is resource that has been demonstrated to New Zealand, after the introduction of available (Ref. 82). be effective in helping smokers to quit pictorial warnings with a supportive One comment from a submitter (see section V.B.6.c of this document). cessation message and quitline representing a State quitline claimed Media campaigns are helpful in information, the average number of new that health care providers are more reaching some smokers who want to monthly calls increased and the likely to address tobacco use in their quit, and can be used in conjunction percentage of first-time callers who patients when they know of an effective with the inclusion of a cessation reported obtaining the quitline number program to which they can refer their resource on the required warnings. It is from tobacco product packaging patients, and that adding a cessation important to ensure that this doubled (Ref. 83). In Brazil, there was a resource to the required warnings will information reaches a broad number of progressive increase in calls to a dramatically increase awareness of this smokers. Inclusion of a cessation quitline in the 6 months following the resource. Several comments from resource on the required warnings is requirement for graphic warnings and submitters representing State quitlines likely to have a broader reach than the inclusion of a quitline number on noted that they receive referrals from media campaigns alone. The evidence cigarette packages. Interviews with clinicians via fax referral services. from one comment is that, even after an people who called the quitline showed One comment from an academic extensive media campaign, that over 92 percent knew about the researcher submitted results from a approximately one quarter of smokers quitline number because it appeared on study that tested one of the proposed surveyed were not aware of the cigarette packs (Ref. 73). We also note required warnings included in the existence of the quitline or that help that Canada has recently proposed proposed rule with and without a was available to obtain information including a quitline number on the cessation resource. This study found about ways to quit. The cessation graphic warnings that will appear on its that when youth and adult participants information will be there each time a packages. were asked to rank order six images consumer looks at a package of Although we are not aware of any tested for use with one of the warning cigarettes or a cigarette advertisement; a studies regarding the inclusion of statements, based on which image pack-a-day smoker potentially would be cessation information on graphic would be most effective for discouraging exposed to the cessation information warnings in cigarette advertisements, it smoking, the image with the cessation more than 7,000 times per year. This seems likely that adding a reference to resource was ranked as the most evidence highlights that cigarette a cessation resource to cigarette effective by more study participants packages are useful communication advertisements would have a similar than any other image. tools for ensuring that smokers are effect as including the reference on (Response) We agree with comments aware of cessation resources. cigarette packages. that there is strong support for including Based on experience in other Inclusion of a cessation resource on a smoking cessation resource on the countries, we anticipate that including a the required warnings is also consistent required warnings. As required by reference to a cessation resource as part with the advice of the FCTC. Although section 906(d) of the FD&C Act, we find of the required warnings will increase the United States has not yet ratified the that addition of a cessation resource is the utilization of that resource. Many FCTC and therefore is not bound by the appropriate for the protection of the foreign countries have included treaty, the United States is a signatory public health because of the benefits, cessation resources on cigarette package and the Guidelines for implementation and lack of risks, to the population as warnings. As described in the of the Treaty provide further support for a whole. This is due, in part, to the comments, these countries have the inclusion of a cessation resource. increased likelihood that existing generally experienced a large increase in The Guidelines for implementation of

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Article 11 of the FCTC (Packaging and did not provide adequate notice for Conference, Inc. v. CAB, 618 F.2d 819, labeling of tobacco products) explain requiring inclusion of a cessation 834 (DC Cir. 1980)) (internal quotations that the provision of advice on cessation resource, and that FDA should not omitted)). and specific sources for cessation help require a cessation resource without Our choice of a specific smoking on tobacco packaging, such as a Web providing an additional opportunity to cessation resource, 1–800–QUIT–NOW site address or a toll-free telephone comment on specific proposed cessation and the State quitlines to which it links, number, can be important in helping resources. is a logical outgrowth of the proposed tobacco users to change their behavior, (Response) We disagree. The rule. We received many comments that and is expected to increase demand for Administrative Procedure Act requires discussed whether FDA should use a cessation-related services. that a notice of proposed rulemaking toll-free telephone number and/or a In addition to providing information include ‘‘either the terms or substance Web site. We also received a comment to increase the likelihood that smokers of the proposed rule or a description of advocating that the Agency include will become aware of the cessation the subjects and issues involved’’ (5 information about contacting a resource and use it to successfully quit, U.S.C. 553(b)(3)). Consistent with this physician for help quitting (see including a cessation resource will also requirement, the NPRM provided Comment 170). Numerous comments help to make the required warnings adequate notice that FDA was identified an existing resource more effective at conveying information considering the inclusion of a cessation (primarily 1–800–QUIT–NOW) as the about the health risks of smoking. As resource in the required warnings and preferred cessation resource for the required warnings. As discussed in noted in the NPRM, studies have found the factors it would consider in that health warnings are more effective section V.B.6.b of this document, many choosing a specific smoking cessation when they are combined with cessation- comments addressed the specific resource. Proposed § 1141.16 related information (75 FR 69524 at criteria proposed for the cessation specifically stated that one or more of 69541). Risk communication research resource and several comments the required warnings ‘‘shall include a indicates that messages that arouse fear provided reasons why 1–800–QUIT– reference to a smoking cessation about the health risks of smoking should NOW meets the criteria identified in the assistance resource’’ (75 FR 69524 at be combined with information on NPRM. In addition to comments 69564). The preamble to the proposed concrete steps that can be taken to received about whether to include a rule explained the goal ‘‘would be to reduce those risks (Ref. 81 (Messages resource and, if so, what resource, as provide a place where smokers and that arouse fear ‘‘appear to be effective discussed in section V.B.6.d of this when they depict a significant and other members of the public can obtain document, the proposed rule was relevant threat * * * and when they smoking cessation information from sufficiently detailed for comments to outline effective responses that appear staff trained specifically to help smokers raise issues regarding implementation easy to accomplish * * *.’’); see also quit by delivering unbiased and details, such as the words surrounding Ref. 55 (explaining the importance of evidence-based information, advice, and the cessation resource. giving smokers who are motivated to support’’ (75 FR 69524 at 69540). The We are generally adopting the criteria quit smoking upon seeing a graphic preamble also explained the range of identified in the NPRM, including the health warning an immediate way to act alternatives available, including use of criteria specific to a toll-free number. on this impulse and access cessation an existing or new quitline or Web site Our changes to the criteria are minor assistance)). In addition, the results (75 FR 69524 at 69540; see Small clarifications that were informed by from one study conducted by an Refiner Lead Phase-Down Task Force v. comments. Thus, the requirement that academic researcher and submitted to EPA, 705 F.2d 506, 549 (DC Cir. 1983) the graphic warnings include a the docket also suggest that adding a (‘‘Agency notice must describe the range reference to a cessation resource is a cessation resource to the required of alternatives being considered with logical outgrowth of the proposed rule warnings is beneficial. When youth and reasonable specificity.’’)). In addition, and further notice and opportunity for adult participants were asked to rank proposed § 1141.16(b) identified comment is not necessary (Air order six images (including one image specific criteria that any referenced Transport Ass’n of America, 732 F.2d at with and without a cessation resource) cessation resource would need to meet 224 (‘‘An Agency adopting final rules tested for use with one of the warning as well as two additional criteria that that differ from its proposed rules is statements, based on which image the resource would need to meet if the required to renotice when the changes would be most effective for discouraging resource was a toll-free telephone are so major that the original notice did smoking, the image with the cessation number (proposed § 1141.16(d)) and two not adequately frame the subjects for resource was ranked as the most additional, but different, criteria that the discussion. * * * The agency need not effective by more study participants resource would need to meet if it was renotice changes that follow logically than any other image. a Web site (proposed § 1141.16(c)). The from or that reasonably develop the (Comment 159) Several tobacco NPRM further explained that the rules it proposed originally’’) (quoting industry comments claimed that it was reference to a smoking cessation Connecticut Light and Power Co. v. difficult to comment on the issue of a resource was proposed to ‘‘be included NRC, 673 F.2d 525, 533 (DC Cir. 1982))). cessation resource, because the as part of one or more of the required An agency is permitted to add specific proposed rule did not identify the warnings and therefore would not details to a rule in response to resource FDA proposed to reference or appear outside of the areas specified for comments even if the proposed rule suggest alternative resources from the required warning’’ (75 FR 69524 at described the requirement in a more among which FDA would choose. 69541). Thus, the ‘‘notice was general manner (Chemical Tobacco industry comments also sufficiently descriptive of the subjects Manufacturers Ass’n v. EPA, 870 F.2d claimed that the NPRM did not indicate and issues involved so that interested 177, 202 (5th Cir. 1989) (finding that how FDA proposed to reference the parties [could] offer informed criticism EPA provided adequate notice for final resource or integrate it into the and comments’’ (Air Transport Ass’n of rule appendices, one of which proposed warning images. For these America v. Civil Aeronautics Bd., 732 established limits for the discharge of reasons, some tobacco industry F.2d 219, 224 (DC Cir. 1980) (quoting certain metals, even though the comments contended that the NPRM National Small Shipments Traffic appendices were not included in the

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proposed rule, because there was resource. Instead, this comment QUIT–NOW as the cessation resource adequate notice that the agency was proposed that FDA rely on the most expressed concern that State quitlines considering establishing limitations recent version of the Public Health would be subject to two sets of ‘‘and this was all the APA demands’’); Service Guideline on Treating Tobacco potentially inconsistent requirements Trans-Pacific Freight Conference of Use and Dependence (2008 PHS because the CDC already maintains Japan/Korea v. Federal Maritime Guideline) (Ref. 66). The rationale for standards for these quitlines. These Comm’n, 650 F.2d 1235, 1248–49 (DC this suggestion was that this guideline is comments proposed that FDA specify Cir. 1980) (finding that the final rule regularly updated to reflect new that quitlines authorized by CDC for merely enumerates more specifically the effective treatments for tobacco connection to the 1–800–QUIT–NOW type of information which the dependence and, therefore, the criteria network are qualified to be the cessation Commission sought, but parties were on would not become out-of-date. In resource included on the required notice that a requirement of more addition, the comment asserted that the warnings. detailed reports was under 2008 PHS Guideline is the gold standard (Response) We believe that it is consideration)). for tobacco cessation in the United important to establish criteria for the b. Criteria for cessation resource. The States, because it is produced by leading cessation resource as part of this rule to NPRM included three paragraphs in cessation experts, updated on a regular ensure that the standards reflected in proposed § 1141.16 detailing criteria basis, and published by HHS. these criteria will be followed for as that would apply, on an ongoing basis, (Response) We agree with the long as the rule is in effect. We do not to any cessation resource chosen in the comment that the 2008 PHS Guideline believe there will be any conflict final rule. The purpose of these is a valuable resource for evidence- between these criteria and CDC’s proposed criteria was to ensure that the based smoking cessation treatments. requirements for State quitlines that are cessation information, advice, and However, the purpose of FDA’s criteria associated with our chosen resource (1– support provided by the cessation is not to reference particular treatment 800–QUIT–NOW). We have worked resource are unbiased and evidence strategies. Rather, these criteria are closely with CDC regarding the choice based (75 FR 69524 at 69540). Proposed designed to ensure that the resource’s of the cessation resource and the criteria § 1141.16(b) described 10 criteria that information, advice, and support are that will be required. Moreover, CDC would be applied to any cessation unbiased and evidence-based. By setting will include the criteria in this rule in resource chosen. Proposed § 1141.16(c) forth a requirement that the cessation its State grantee funding requirements, described two additional criteria that resource provide evidence-based and will work with leading quitline would apply if the cessation resource treatment strategies, the resource will be experts to review, and where necessary, chosen were a Web site, and proposed able to employ newer strategies as more update existing scripting such as to § 1141.16(d) described two additional research is done on the most effective accurately reflect current FDA-approved criteria that would apply if the cessation approaches to smoking cessation cessation medications. resource chosen were a toll-free treatments. (Comment 163) Many comments from telephone number. In addition, the (Comment 161) Comments public health advocacy groups and preamble to the proposed rule provided representing tobacco product representatives of quitlines expressed examples and additional explanation to manufacturers claimed that the criteria concern about the criterion in proposed help clarify the proposed criteria (75 FR set forth in proposed § 1141.16 are § 1141.16(b)(7) regarding providing 69524 at 69540). unspecific or that this section uses information, advice, and support that is As discussed more fully in section vague terminology. One comment evidence-based, unbiased, and relevant V.B.6.c of this document, we have argued that the terminology is subject to to tobacco cessation. In particular, decided that the appropriate cessation conflicting interpretations. comments were concerned about the resource is a toll-free telephone number (Response) We disagree. The criteria sentence in the preamble to the (1–800–QUIT–NOW). Therefore, our in the proposed rule, and generally proposed rule that states that a cessation final rule does not include the criteria adopted in this final rule, are extensive resource cannot include derogatory proposed for a cessation resource that is and detailed. In addition, the notice and statements regarding cigarette a Web site. We have incorporated the comment process gave the public an manufacturers, importers, distributors, two criteria proposed for a cessation opportunity to raise questions about our or retailers, or advocate public policy resource that is a toll-free telephone use and interpretation of specific terms. changes (75 FR 69524 at 69540). These number into § 1141.16(b) as paragraphs The proposed rule provided adequate comments asserted that the term 11 and 12, deleted the proposed criteria detail for a number of comments to ‘‘derogatory statements’’ is vague and for a Web site, and added a paragraph request revisions and clarifications. We could lead to challenges from industry. clarifying an issue raised in the have responded to the significant issues The comments asserted that the tobacco comments. raised in the comments. As explained industry has made similar challenges in In the following paragraphs, we more fully in response to Comments 163 the context of interpreting the Master summarize and respond to comments and 164, in the final rule, we revised the Settlement Agreement of 1998. regarding our general criteria for a criteria to clarify that quitlines may (Response) We disagree that the term cessation resource, as well as criteria tailor their services to meet the needs of ‘‘derogatory statements’’ is vague. relating to a cessation resource that is a individual callers and added more Moreover, neither the proposed nor the telephone quitline. However, because explanation and examples to the final version of § 1141.16(b) or (c) we are not choosing a Web site as the preamble to further clarify issues raised includes that term. Instead, cessation resource, we do not respond to by comments. The criteria we are § 1141.16(b)(7) states a cessation specific suggestions regarding the adopting will ensure that smokers using resource must ‘‘[p]rovide information, criteria in proposed § 1141.16(c) and the referenced cessation resource advice, and support that is evidence- other comments about criteria for a receive unbiased and evidence-based based, unbiased (including with respect cessation resource that is a Web site. services suited to their individual to products, services, persons, and other (Comment 160) One comment needs. entities), and relevant to tobacco suggested that the rule does not need to (Comment 162) Several comments cessation.’’ The focus of the cessation specify criteria for the cessation that supported the choice of 1–800– resource should be about changing a

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smoker’s behavior by providing factual introductory language to clarify that a ensuring that the resource does not information and evidence-based advice quitline may tailor individual calls as provide opinions, advice, or support and support about tobacco cessation. appropriate to meet the smoking that are biased or not supported by Our purpose in adding to the preamble cessation needs of individual callers. appropriate evidence. the example about derogatory Thus, for example, if a caller says that (Comment 165) One comment statements was to emphasize that our he or she has attempted to quit many representing quitlines suggested that chosen cessation resource must not times and knows what to expect, the FDA either delete the criterion provide biased information about, for quitline does not need to provide factual described in proposed § 1141.16(b)(10) example, tobacco companies. The information about what smokers can that prohibits the cessation resource preamble to the proposed rule expect when trying to quit. Instead, the from encouraging ‘‘the use of any non- contrasted derogatory statements as well quitline might focus the counseling on evidence-based smoking cessation as statements advocating public policy practical advice about how to deal with practices,’’ or replace the word changes with factual information common issues faced by users trying to ‘‘practices’’ with ‘‘treatment.’’ This relevant to tobacco cessation. We quit or evidence-based information comment explained that practices such conclude that this distinction should be about effective relapse prevention as coping strategies for dealing with retained in the final rule. Nonetheless, strategies. In addition, we changed cravings have not been as rigorously as discussed in the response to ‘‘users’’ to ‘‘smokers’’ in § 1141.16(b)(3) tested as medications and may not be Comment 164, the final rule clarifies the for consistent terminology with the rest considered evidence-based. This distinction between providing factual of the paragraph. comment asserted that the criterion in proposed § 1141.16(b)(3), requiring a information, advice, and support and The final rule also contains a cessation resource to provide practical providing biased opinions or advice. paragraph (c) in § 1141.16 that addresses (Comment 164) One comment advice about how to deal with common general requirements for the cessation representing quitlines expressed issues faced by users trying to quit, resource, rather than the types of concern that many of the cessation adequately addresses this issue. information to be provided to resource criteria described in proposed (Response) We understand the consumers seeking information or § 1141.16(b) and the preamble to the concerns expressed by this comment assistance. Section 1141.16(c) is proposed rule may interfere with the and agree that a cessation resource primarily composed of the criteria in ability of counselors at a telephone should be permitted to discuss coping proposed § 1141.16(b)(8) through (b)(10) quitline to tailor information to a strategies for dealing with cravings (e.g., specific caller. Specifically, this and (d). Except for the requirements chewing gum) that may not have been comment requested that FDA delete regarding staff training and the rigorously tested in a scientific manner. many of the criteria or clarify that they maintenance of appropriate controls, However, because the distinction refer to the capacity of the quitline this paragraph lists prohibitions for the between treatment and practices is overall, and not to each interaction with cessation resource. For example, the unclear, we conclude that a broad term a caller. Also, this comment requested cessation resource must not provide or such as ‘‘practices’’ is appropriate in that FDA either delete the term otherwise encourage the use of any drug order to ensure that evidence-based ‘‘unbiased’’ in proposed § 1141.16(b)(7), or other medical product that FDA has research is being used to provide callers or define that term to include the not approved for tobacco cessation. As with effective services. Using the concept of tailoring a call to the needs described more fully in the response to broader term ‘‘practices’’ also avoids the of an individual caller. In addition, this Comment 166, we have clarified that the possibility that definitional questions comment asked that FDA remove the cessation resource may tailor about whether something is a treatment word ‘‘unbiased’’ from proposed information about cessation products to will interfere with the ability of the § 1141.16(d)(1) regarding staff training meet the particularized needs of an cessation resource to provide effective for a telephone quitline. individual caller and may provide cessation services to smokers. Deleting (Response) We agree that this issue particular FDA-approved cessation proposed § 1141.16(b)(10) completely, needs to be clarified. It was not our products to callers, based on availability or replacing the word ‘‘practices’’ with intent that the criteria described in of those products to the resource. With ‘‘treatment,’’ may result in cessation proposed § 1141.16 would limit the respect to the comment expressing resources encouraging non-evidence- ability of the cessation resource to tailor concern about the use of the term based practices even though evidence- an interaction to the needs of the ‘‘unbiased’’ in the staff training criterion based practices are available. Section individual smoker seeking help. In fact, precluding the ability to tailor 1141.16(b)(3) permits the cessation as discussed below, we believe that one information, the revisions to paragraph resource to provide practical advice, of the many benefits of choosing a (b) address concerns about the ability of and the practices described in the telephone quitline as the cessation cessation resource staff to tailor comment would be considered resource is the ability of the resource to information to the needs of an ‘‘practical advice’’ rather than ‘‘non- tailor counseling sessions to individual individual caller. The criterion in evidence-based practices.’’ In addition, callers. Although we do not agree that paragraph (c) about staff training, when as discussed in the comment, a it is appropriate to delete any of the read in conjunction with paragraph (b), cessation resource is permitted to tailor general criteria or the word ‘‘unbiased’’ does not preclude tailoring of each counseling session to the needs of from § 1141.16(b)(7), we have revised information during individual calls. the individual caller. the rule to reorganize the criteria Therefore, it is unnecessary to delete the (Comment 166) FDA received several described in proposed § 1141.16(b) and term ‘‘unbiased’’ from § 1141.16(c)(8) to comments relating to the cessation (d). The final rule includes a paragraph address this concern. We conclude that resource providing or discussing (b) describing the types of services that the revised criteria in paragraphs (b) and particular smoking cessation drug a cessation resource must provide (c) of § 1141.16 will ensure that the products. One comment representing a generally. The criteria in § 1141.16(b)(1) cessation resource has the flexibility to manufacturer of smoking cessation drug through (b)(7) were previously provide counseling about smoking products suggested that the Agency described in proposed § 1141.16(b)(1) cessation that is appropriate to the permit the resource to provide one or through (b)(7), however, we revised the needs of an individual caller while still more FDA-approved over-the-counter

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cessation products, but not include not believe that it is appropriate for the and support that are unbiased and language in the rule that prohibits the cessation resource that we include in a evidence-based. cessation resource from ‘‘advertising or required warning to promote any (Comment 168) One comment promoting a particular product.’’ This particular product. recommended that an additional role of comment claimed that there is evidence (Comment 167) Several comments a cessation resource should be to direct that recognizable brands of smoking proposed that additional criteria be smokers (who request it) to local cessation products can be important added to the criteria proposed in the specialist face-to-face treatment services tools to promote cessation (Ref. 84). NPRM. One comment suggested adding and to provide accessible information Comments representing telephone an additional criterion that the cessation on Medicaid, Medicare, and other large quitlines and a public health advocacy resource must provide evidence-based insurers’ coverage for tobacco group requested that FDA clarify that advice regarding the protection of dependence treatment. simply mentioning a particular children and other nonsmokers from (Response) Our primary objective in cessation product does not constitute secondhand smoke. This comment requiring that referenced cessation advertising or promoting a particular reasoned that two of the warning resources comply with the criteria is to product, so long as the resource makes statements address the dangers of ensure that the cessation resource clear it does not recommend the use of secondhand smoke and the cessation chosen provides evidence-based one cessation product or brand over resource should be prepared to counsel counseling to help smokers quit. Our another. smokers who seek assistance after criteria are designed to ensure that the cessation resource will continue to meet (Response) The final rule has been seeing these messages. Another certain minimum standards. While not revised to clarify that a cessation comment recommended adding a criterion to prohibit the cessation required by the criteria in this resource may tailor a discussion of regulation, a referenced cessation resource from promoting a tobacco cessation medications for an individual resource is not precluded from industry cessation program. This caller. As noted in the preamble to the providing additional relevant factual comment claimed that research has proposed rule, under the criteria the information, such as information about demonstrated that tobacco industry cessation resource may provide one or reimbursement for tobacco dependence sponsored cessation resources either more FDA-approved over-the-counter treatments. cessation products, provided that it does have no effect on smoking prevalence or c. Choice of cessation resource. The so in a manner that does not advertise actually cause increased smoking (Refs. NPRM did not specify a particular or promote a particular product (75 FR 85 and 86). One comment from a cessation resource. Rather, it noted that 69524 at 69540). We agree that, in the submitter representing quitlines there are a number of possible context of individual counseling, one recommended the addition of a new alternatives, including use of an existing medication may be suggested over criterion that would require the or new quitline or Web site, where another, based on an individual cessation resource to provide proactive, smokers and other members of the smoker’s health needs and prior multi-call counseling services. The public can obtain current unbiased, experience with cessation medications. comment claimed that there is evidence factual smoking cessation information For example, a quitline counselor may these types of services are effective. (75 FR 69524 at 69540). Based on the take into account warnings, precautions, (Response) We recognize that there information before the Agency, and contraindications identified in the could be additional criteria for a including the information provided in labeling of a specific drug product in cessation resource that would require the comments, we have chosen the relation to an individual caller. Also, a the resource to provide broader services. Network, which uses the toll-free quitline counselor may suggest a However, we have designed the criteria telephone number 1–800–QUIT–NOW particular medication based on the in this final rule to focus on the (1–800–784–8669), as the cessation caller’s prior experience with cessation minimum services that must be resource to include on all nine required medications (e.g., not recommend a provided by an effective cessation warnings. The Network is the single medication that previously caused resource and the minimum standards point of access to reach State-based significant side effects or did not work; the resource must meet. We are mindful quitlines in all 50 states, the District of recommend a medication that worked that existing cessation resources have Columbia, Puerto Rico, and Guam. well in the past). In addition, a cessation varied budgets and do not want to Since 2005, CDC and NCI have resource may provide one or more FDA- require additional standards that, while partnered with States to create the approved over-the-counter cessation possibly beneficial, would disqualify Network. NCI manages the 1–800– products, based on availability of the some effective treatment programs that QUIT–NOW telephone number, along product(s) to the resource. A cessation do not have the resources to provide with appropriate telecommunications resource may also mention the these services. We note, however, that and routing infrastructure, to ensure availability of free medication, provided the criteria described in § 1141.16 (b) that calls are transferred to the it does so in a manner that does not and (c) do not preclude any cessation appropriate State or territory quitline advertise or promote a particular resource from providing additional based on the area code of the caller. product. However, the resource must unbiased, evidence-based cessation Calls from U.S. territories that do not not advocate or promote a cessation information, advice, and support. With have a quitline are routed to an NCI-run product, such as by recommending the respect to prohibiting the promotion of quitline. CDC and individual States or use of particular cessation products or a tobacco industry cessation program on territories provide the funding for the brands over others to callers generally. the basis that they are not effective, we quitlines. CDC provides funding All products that have been approved conclude that the addition of a separate through cooperative agreements as part with smoking cessation claims have criterion is unnecessary. The cessation of the National Tobacco Control been found by FDA to be safe and resource that will appear in the required Program. effective for the approved indication. warnings—1–800–QUIT–NOW—is run As discussed more fully in the context Even if there might be benefits by government entities, and the criteria of comments and responses in the associated with brand recognition for a are designed to ensure that the resource following paragraphs, we find that this smoking cessation drug product, we do provides cessation information, advice, cessation resource, which was strongly

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favored in many comments, will QUIT–NOW to the required warnings quitlines significantly increase provide people in the United States holds unprecedented potential to close abstinence rates compared to minimal with access to unbiased, evidence-based the gaps and disparities in treatment or no counseling interventions. The smoking cessation information, advice, awareness and use. One comment 2008 PHS Guideline also found that use and support. We have determined that representing a State quitline argued that of quitline counseling in conjunction including this cessation resource as part quitlines can help address racial or with cessation medication significantly of the required warnings will increase ethnic disparities in access to effective improves abstinence rates compared to the likelihood that smokers will quit tobacco treatment. For example, the use of medication with minimal or smoking and thereby provide African-Americans have been no counseling (Ref. 66 at pp. 91–92; see substantial public health benefits by significantly overrepresented among also Ref. 88). Consequently, quitlines reducing the life-threatening quitline callers in California, relative to are an important part of the HHS consequences associated with continued the proportion of African-American Tobacco Control Strategic Action Plan cigarette use. Therefore, we conclude tobacco users in that State. Several (Ref. 89). that including a reference to 1–800– comments stated that quitlines provide In addition, there is evidence that QUIT–NOW as part of all the required services in languages other than English, knowing about the availability of a warnings is appropriate for the particularly Spanish, and provide quitline increases quit attempts and protection of the public health. materials to important population successful cessation even among (Comment 169) Comments favoring groups (e.g., youth, pregnant women, smokers who do not call the quitline inclusion of a cessation resource racial/ethnic populations). One (Ref. 88 (finding ‘‘[t]elephone quitlines generally preferred the use of a comment representing a State quitline provide an important route of access to telephone quitline. In particular, most of asserted that quitlines can help address support for smokers, and call-back these comments advocated the use of 1– disparities related to socioeconomic counselling enhances their 800–QUIT–NOW. The comments status. In California, utilization of usefulness’’)). For example, one study of pointed to a robust body of evidence quitline service is highest among low the effect of a smokers’ hotline as an showing that proactive telephone socioeconomic status tobacco users. adjunct to self-help manuals found ‘‘it is counseling is effective in helping This comment also claimed that the unlikely that higher abstinence rates smokers to quit successfully. Several attractiveness of quitlines to tobacco among users [of the hotline] accounted comments cited statistics from users with low socioeconomic status is for the total differences in outcome individual State quitlines about the related to the fact that services are between hotline and manual only types of services provided and success provided without a charge and are counties. It is possible that simply rates. In addition, several comments accessible by telephone, eliminating the knowing that telephone help was there asserted that quitlines associated with need to arrange for transportation or if needed enhanced abstinence even 1–800–QUIT–NOW generally meet the child care. According to this comment, among nonusers’’ (Ref. 82). A CDC criteria for a cessation resource these factors can be significant barriers report hypothesized that a possible specified in the NPRM. for individuals with modest resources. explanation is that ‘‘knowledge of Many comments discussed the Another quitline provider stated that cessation services, engendered through advantages of choosing 1–800–QUIT– quitlines are disproportionately used by promotion, increases tobacco users’ NOW. In support of the choice of a the chronically ill and those who are belief in the normalcy of quitting, which telephone quitline over a Web-based socially and economically stressed. This may lead to increased quit attempts cessation resource, several comments comment claimed that, arguably, these among people who have access to the noted the broad penetration of groups have the greatest need for services, even those who do not use telephone access, including among low support because they have a higher them’’ (Ref. 90). income and minority populations. prevalence of smoking and are Another factor that we considered in These comments noted that Internet disproportionately affected by tobacco- choosing a telephone quitline is that access has much lower penetration related health concerns. telephone access within the United among the American public, One comment representing a public States is nearly universal. According to particularly in many groups with high health advocacy group pointed out that a 2010 Federal Communications rates of smoking (e.g., low income, low designation of a single quitline number Commission statistical report, level of education). Many comments would avoid the difficulty of household telephone subscribership in that advocated the use of 1–800–QUIT– manufacturers having to print different the United States was 96 percent in NOW noted that it has an existing dialing information depending on where March 2010. This report shows that, infrastructure that is available in all 50 the cigarette package will be sold. even among households with annual states, the District of Columbia, Puerto (Response) We agree with comments incomes as low as $25,000, telephone Rico, and Guam. One comment stated that a telephone quitline is the most penetration was over 90 percent in that all quitlines associated with 1–800– effective means of ensuring that all 2009, including among African- QUIT–NOW are at least several years Americans have access to unbiased, Americans and Hispanics (Ref. 91). old. evidence-based smoking cessation Currently, Internet use and broadband Several comments argued that information, advice, and support. We penetration is much lower than inclusion of 1–800–QUIT–NOW on have decided to use the Network as the telephone penetration in the United cigarette packages could address issues cessation resource and its portal States, particularly among low income relating to poorer smoking cessation number, 1–800–QUIT–NOW, will be groups, certain racial and ethnic outcomes among racial and ethnic included as part of electronic files for minorities, and households with low minorities, as well as populations with the required warnings that are available education levels (Ref. 92). low income and/or low education. One in the IBR document described in Beyond their wide accessibility, academic noted that smokers in these section V.B.4 of this document. quitlines are also successful in helping groups try to quit as often as other A key factor in our decision is that the certain high risk populations and other smokers but are less likely to use evidence regarding the effectiveness of important demographic groups. One effective treatments (citing Ref. 87). The telephone quitlines is well documented. comment asserted that low income and comment claimed that adding 1–800– The 2008 PHS Guideline found that uninsured smokers, those with the

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lowest levels of formal education, and health benefits of quitting) to smokers Australian and European Union graphic those in racial/ethnic populations with who are not ready to quit but who want warnings recognize the role that the highest smoking rates try to quit as additional information. physicians play in assisting patients’ often as other smokers, but are far less With respect to our choice of the cessation efforts. likely to use effective treatments. For Network and its telephone number, 1– (Response) We agree that physicians, example, smokers in several racial and 800–QUIT–NOW, for the quitline particularly primary care physicians, ethnic groups attempt to quit as often as cessation resource, we have determined and other health care providers are a or more often than nonminority smokers that this resource will fulfill the goal to very helpful resource for encouraging but use effective treatments less often provide a place where smokers and smokers to quit (Ref. 66 at p. 35). and have lower success rates (Ref. 66 at other members of the public can obtain However, we decline to include p. 156). Similarly, low socioeconomic smoking cessation information from language on the required warnings status smokers or those with limited staffed trained specifically to help encouraging smokers to see their doctor. education express significant interest in smokers quit by delivering current, Many Americans do not have an quitting and appear to benefit from unbiased, and evidence-based ongoing relationship with a physician. treatment. However, these smokers are information, advice, and support. The Recent evidence indicates that the less likely to receive cessation quitlines that compose the Network, the United States may be suffering from a assistance (Id. at p. 151). One study telecommunications infrastructure shortage of primary care physicians, concluded that non-Hispanic black and supporting the Network, and the making it less likely that they would be Hispanic smokers who attempted to quit telephone number, 1–800–QUIT–NOW, available to provide cessation smoking were significantly less likely to are already well established and provide information to smokers (see Ref. 95 for use cessation aids, and that this has smoking cessation services to people statistics on decreasing numbers of U.S. implications for successful quitting throughout the United States. medical school graduates selecting a among minority smokers (Ref. 87). Comments that advocated the use of a family medicine career). In addition, Several comments, however, explained specific quitline referred to 1–800– unlike the selected quitline, we would that at least some quitlines receive a QUIT–NOW as the preferred cessation not have a practical means to monitor disproportionate numbers of calls from resource. By using an existing resource, health care provider compliance with certain minority or disadvantaged infrastructure, and telephone number, the criteria the Agency is establishing in populations (see, e.g., Ref. 93). In light we can leverage the Network’s § 1141.16(b). Studies indicate that rates of the overall low rates of calls to established structure and experience of physician adherence to similar quitlines (approximately 1 percent of providing cessation services. This practice guidelines for smoking smokers call quitlines, although this choice also avoids the costs associated cessation advice vary widely (see Ref. 96). For these reasons, it is preferable to percentage varies by State and how with establishing a new quitline. In addition, we agree with comments include a reference to 1–800–QUIT– much the State promotes its quitline), that the individual State and territory NOW on the required warnings. We even a disproportionately high volume quitlines that are associated with 1– note, however, that quitlines frequently of calls from important demographic 800–QUIT–NOW generally meet the refer people to their primary care groups is not enough to alter the overall criteria specified in § 1141.16(b). We physicians (e.g., if a caller has further quit rates for these groups. However, as understand, however, that these questions about the use of medications). discussed in section V.B.6.a of this quitlines have some differences in In addition, there is limited space document, there is strong evidence that funding resources and consequently available for including information there will be an increase in call volume provide differing levels of service. For about a cessation resource. The size of to quitlines after the required warnings example, some State quitlines provide the required warnings is relatively small appear on cigarette packages and in longer hours of service than others. and the textual warning statement and cigarette advertising. This increase in Based on the statistics provided in some color graphic image included in each use of quitlines could have an important comments, it is possible that not all of warning must be clear, conspicuous, impact on high risk and other important the individual State and territory and legible as required by section 4 of demographic groups if they continue to quitlines associated with 1–800–QUIT– FCLAA. In light of the limited space constitute a significant percentage of NOW meet all of the criteria we are available, we have determined that calls to quitlines. adopting in § 1141.16(b). To assure that including an additional message In addition, a telephone quitline these criteria are met, CDC will include encouraging smokers to contact their provides an excellent opportunity to these criteria beginning with its 2013 physician or health care provider is not tailor counseling sessions and provide National Tobacco Control Program appropriate at this time. additional materials for specific funding opportunity announcement and (Comment 171) Some comments populations. The 2008 PHS Guideline HHS will monitor the quitlines for urged FDA to include a Web site as a also found that individually tailoring compliance with the criteria on an cessation resource. Generally these materials to address smoker-specific ongoing basis and will take appropriate comments suggested that a Web site variables (e.g., support sources steps to address any noncompliance. would be a useful cessation resource in available, time lapse since quitting, (Comment 170) One medical addition to a telephone quitline. For concerns about quitting) has been organization suggested that the example, one public health advocacy shown to be effective and have broad reference to the smoking cessation group noted that there are advantages to reach (Ref. 66 at p. 92). Several resource in the required warnings utilizing both quitlines and Internet comments noted that virtually all State should also include a message resources. According to this comment, quitlines associated with 1–800–QUIT– encouraging smokers to contact their while quitlines provide individualized NOW provide specialized materials to physician or health care provider. This telephone counseling, a Web site special populations, including pregnant comment cited studies to support the provides support 24 hours per day. One women, racial and ethnic populations, proposition that physician advice is comment from a public health advocacy and youth. Quitlines can also provide effective in encouraging smoking group claimed that about 10 million information (e.g., about the negative cessation (citing, e.g., Ref. 94). This smokers search online for smoking health consequences of smoking or the comment also noted that both cessation assistance every year, and it is

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particularly important for the required There is stronger scientific support that the cessation resource, 1–800–QUIT– warnings to include Web-based telephone quitlines are effective, they NOW. We disagree with the request that resources because there are a large are more widely available to a broader we provide a variety of options for number of Internet sites that ostensibly cross section of Americans, particularly cessation resources and include those offer quitting assistance but do not offer groups with higher rates of smoking and options in the electronic files for the evidence-based cessation help. Several lower access to cessation services, and required warnings. Such an approach comments acknowledged that the 2008 there is a strong national quitline could be confusing to consumers, PHS Guideline did not find enough infrastructure in place. In light of the because the required warnings would evidence to recommend computer-based limited space available on the required appear with a different cessation interventions, but noted that the 2008 warnings and the need to ensure that resource on different packages of PHS Guideline also concluded that the graphic images and textual warning cigarettes and in different these interventions remain promising. statements are clear, conspicuous, and advertisements. Also, it would be Some comments also noted that Internet legible, we do not think it is appropriate difficult to monitor many cessation use is low in many groups with high at this time to include both a telephone resources to ensure that each one meets rates of smoking (e.g., low income, quitline and a Web site address on all the criteria established in § 1141.16(b) racial and ethnic minority groups). required warnings. We intend to and (c). By choosing one, existing toll- However, several comments advocating evaluate this possibility in the future free telephone number that is under the inclusion of a Web site resource noted when we are designing and testing control of NCI, provides access to that many cessation services, including revised versions of the required consumers throughout the country, and many quitlines and health plans, are warnings. includes State quitlines that have utilizing the Internet to provide d. Implementation issues. Proposed cooperative agreements with CDC, we combined telephone counseling and § 1141.16(a) stated that a required have assurances that our cessation Web-based cessation treatment. One warning must include a reference to a resource criteria will be followed. comment suggested that as American smoking cessation assistance resource as (Comment 173) Several comments culture adopts different forms of specified in the IBR document. The mentioned that an increase in the communication, it will be important to preamble to the proposed rule explained volume of calls to State quitlines may assess the effectiveness of using new that the smoking cessation information increase funding needs. These technologies and approaches. This would be included as part of the comments suggested that additional comment encouraged FDA to fund required warning and would not appear resources should be provided to State research to learn which approaches will outside of the areas specified for the quitlines. encourage the most people to quit required warning. In other words, the (Response) We expect that inclusion smoking. cessation resource would be within the of 1–800–QUIT–NOW on the required One comment from the tobacco top 50 percent of the front and rear warnings will increase the volume of industry claimed that reference to a panels of cigarette packages and within calls to State quitlines. While some smoking cessation Web site may raise the 20 percent of the area of quitlines may currently have some additional implementation issues and advertisements occupied by the additional capacity, there will likely be requested an opportunity to comment in required warning (75 FR 69524 at need for additional resources. In the advance of such a requirement. This 69541). We received several comments fiscal year 2012 President’s Budget, comment did not identify any specific regarding how a cessation resource there is $25 million from the Prevention issues associated with reference to a should appear in the required warning and Public Health Fund allocated for smoking cessation Web site. and other implementation issues CDC to spend on the National Network (Response) We recognize that Web relating to inclusion of a cessation of Tobacco Cessation Quitlines. sites are another important source of resource in the required warning. These Additionally, the Centers for Medicare smoking cessation information and comments and our responses are and Medicaid Services is working with interventions. Although the 2008 PHS summarized in the following the State Medicaid Directors to permit Guideline did not recommend the use of paragraphs. tobacco quitlines as an allowable Web-based interventions, it concluded (Comment 172) A comment Medicaid administrative activity. that ‘‘[g]iven the potential reach and low representing small tobacco product (Comment 174) One comment costs of such interventions * * * they manufacturers expressed confusion encouraged FDA to require that the remain a highly promising delivery about whether FDA would add the cessation resource be displayed as a system for [treating] tobacco reference to a cessation resource to the telephone number (1–800–784–8669) in dependence’’ (Ref. 66 at p. 94). We also required warnings or whether a addition to 1–800–QUIT–NOW because recognize that Internet use is highest manufacturer would have to select the some wireless phones do not have among younger populations, and thus cessation resource and incorporate it letters on the keypad. However, another might be a useful tool to intervene with into the required warning. The comment comment representing a quitline young smokers, given that maximum noted a preference that FDA provide the expressed the view that it is important cessation benefits are gained by quitting specific language for the cessation to use the letters in 1–800–QUIT–NOW at a younger age. Furthermore, Web sites resource. However, one small tobacco rather than the telephone number can provide information to smokers who product manufacturer asked that FDA because it is itself a cogent cessation are not ready to quit but who are provide a variety of options for message. seeking additional information about cessation resources and include those (Response) We agree there would be cessation. options in the electronic files for the benefits to identifying the cessation However, we have decided not to required warnings provided by the resource using 1–800–QUIT–NOW as include a Web site as the cessation Agency. well as the telephone number 1–800– resource incorporated in the required (Response) We have selected 1–800– 784–8669. However, as explained warnings. For the reasons explained QUIT–NOW as the cessation resource previously, there is very limited space more fully above, we find that a that must appear on the required for identifying the cessation resource. telephone quitline is a better overall warnings. The required warnings in the The use of 1–800–QUIT–NOW is a way cessation resource than a Web site. IBR document include the reference to to provide the number for people to call

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while in the same space providing information, advice, and support companies to adapt the electronic files information about what the number is regarding smoking cessation. provided in the IBR document. To help for. Using less space for the cessation (Comment 176) One comment from an prevent distortion of the image and text resource helps ensure the required academic institution encouraged FDA to and to minimize the need for warning remains clear, conspicuous, require, in addition to a quitline adaptation, we are providing electronic and legible and appears within the number, clear encouragement of action files in different formats designed to fit specified area. Moreover, the use of steps for quitting. This comment packaging of various sizes and shapes. letters is likely to be easier for people to recognized that space on the required We are adding language to the IBR remember. The Agency also believes warnings is limited and suggested that document that provides instructions as most telephones in use still include package inserts and onserts are one way to when each of the formats must be letters on keypads and that toll-free of accomplishing this without used. The instructions are based on the telephone numbers are frequently compromising the visual impact of the aspect ratio of the display area where identified using these letters. As stated graphic warnings. the required warning must appear. This previously, we will also conduct (Response) A requirement to add language also describes the research and keep abreast of scientific onserts or inserts is beyond the scope of requirements companies must follow developments regarding the efficacy of this rulemaking and, therefore, we when adapting the electronic files various required warnings and the types decline to require them here. provided in the IBR document. For and elements of various warnings that example, the requirements state that improve efficacy, including elements VI. Comments Regarding each of the different elements of the related to identifying cessation Implementation Issues warning (i.e., the image, the textual resources. A. Technical Issues Regarding warning statement and reference to the (Comment 175) Several comments Compliance cessation resource) must, to the extent addressed the words that would signal possible, maintain the relative scale and Section 1141.12 refers to ‘‘Cigarette the appearance of a cessation resource. proportions of the elements as displayed Required Warnings,’’ which is These comments described experience in the relevant electronic file, and the incorporated by reference (IBR) in from New Zealand that showed positions of each of these elements must increases in both quitline number accordance with 5 U.S.C. 552(a) and be maintained relative to each other. recognition and the number of callers 1 CFR part 51. The IBR document (Comment 178) Two comments from reporting cigarette packages as the includes electronic files of images that cigarette manufacturers requested source for learning the quitline number must be included on all cigarette clarification concerning how companies after the introduction of new graphic packages, and in all cigarette should incorporate the required warnings with a redesigned reference to advertisements. warnings on packages with hinged lids. a cessation resource (i.e., ‘‘You CAN In response to the proposed rule, These comments stated that the content quit smoking. Call Quitline 0800 778 some comments, including comments of warnings printed on the hinged lids 778, or talk to a quit smoking from cigarette manufacturers and can shift up or down by about 1 mm at provider’’). The prior warning said ‘‘For tobacco industry trade associations, the point where the lid meets the front more information call’’ next to a raised issues relating to the electronic of the pack due to normal variations in telephone number. According to one files and the implementation of the production of the packaging. These study, there was a 24 percent increase graphic warnings on cigarette packages comments recommended that FDA in reported recognition of the quitline and in cigarette advertisements. Those design the warnings with all text located number after this change (Ref. 69). Also, comments, and FDA’s responses, are either above or below the hinged lid, or in the first full year after the discussed in the following paragraphs. allow for minor variations in how the introduction of the new graphic (Comment 177) Comments from two graphic warnings appear on cigarette warnings, the volume of calls to the tobacco product manufacturers stated packs due to this manufacturing quitline increased significantly and 26 that they would need to make certain variability. percent of callers reported cigarette technical adjustments to the single sized (Response) We agree that the integrity packages as the source of the number graphic warnings published with the of the warning must be maintained on (compared to 7.5 percent the prior year) proposed rule in order to ensure that the packages to ensure that the warning is (Id., Wilson 10/10). One academic warning fits packaging of varying sizes clear and legible. To clarify the researcher suggested a short, direct ‘‘call and shapes. According to the comments, requirements that companies must to action’’ phrase to motivate cessation if FDA provided only the single warning follow when they adapt the electronic behavior. Similarly, another comment format published with the proposed files for hinged lid packages, we have from an academic institution suggested rule, the company would need to adjust added language to the IBR document that the warnings provide the smoker the height-to-width ratio (i.e., aspect that permits companies to separate two with avenues to take in order to quit and ratio) of that warning in order to cover lines of text within the textual warning simultaneously instill confidence in the 50 percent of the front and rear panels statement so that the line at the location user that he or she can take action. of various package configurations. where the lid is to open cuts across the (Response) As stated previously, there However, adjusting the aspect ratio, background space between two lines is limited space for the cessation such as by elongating or compressing rather than through a line of text. This resource on the required warnings. the warning, could distort the graphic provision will allow companies to adapt Therefore, we have determined that the image and/or textual warning statement. the electronic files provided in the IBR cessation resource will be identified These comments recommended that document to ensure that the textual solely by the telephone number 1–800– FDA ensure that manufacturers are able warning statement is not severed when QUIT–NOW. In the limited space to adapt the graphic warnings to fit the package is opened and is clear, available, we have determined that this cigarette packages of varying sizes and conspicuous, and legible in accordance telephone number and its context shapes and provide guidance about how with section 4 of FCLAA. According to provide sufficient information such that to adapt the warnings. this language in the IBR document, viewers will understand that a call to (Response) We agree that the size and companies are specifically prohibited the telephone number will provide shape of certain packages might require from severing any word in the textual

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statement and are required to ensure to move the upper boundary of the packaging. The other comment that the integrity of the warning will be display area of the warning so that it recommended that FDA permit the use restored when the package is closed. We runs along a line that is parallel to and of tear tapes and that the Agency use note that product packages with hinged not more than 0.375 inches from the top enforcement discretion to allow lids are widely prevalent in countries edge of the package. The companies companies to potentially obstruct the that already require graphic warnings compress the vertical size of the image required warning before the package is and, based on that experience, we and then shift it down (so that it stays opened for the first time. conclude that this new provision should within the top 50 percent of the (Response) We have determined that provide companies with the flexibility package). This language also requires companies can use cellophane tear that they need for displaying the companies who do this to ensure that, tapes, and the final regulation does not warnings on packages with hinged lids. to the extent the file must be adapted to prohibit such use on cigarette (Comment 179) Two comments, from fit the dimensions of the warning area packaging. We further have determined a cigarette manufacturer and a tobacco below the closure, the proportions of the that it is technologically feasible to use company trade association, raised a required warning must be maintained. clear tear tape in a manner that does not concern about incorporating the In addition, the instructions in the IBR obstruct the required warning before the required warnings on ‘‘soft pack’’ style document specify that the closure and cigarette package is opened for the first packaging. These comments stated that the portion of the packaging that time, and note that clear tear tape is ‘‘soft pack’’ style packaging is appears between the top edge of the widely used on product packaging in manufactured through a process in package and the upper boundary of the other countries that require graphic which the top of the package is folded display area of the required warning warnings. We are not aware that this has down after cigarettes are inserted and must be either solid black or solid created any substantial technical held together by a small overwrap white. This will allow companies to difficulty in the production of cigarette closure, or ‘‘stamp.’’ Historically, the continue to produce ‘‘soft pack’’ style packages, nor are we aware that clear closure is made of opaque paper and packaging with closures at the top tear tape has led to any significant applied with glue to hold the package in center of the pack without obstructing obstruction of the graphic warnings. If a place. According to these comments, the the required warning. However, if we company has a unique problem with closure hangs down approximately determine that it would be regard to its packaging, it should raise 0.375 inches over the top center of the technologically feasible to incorporate this issue with us, and the difficulty can front and back panels of the package. the required warnings on ‘‘soft pack’’ be addressed on an individual basis. We The closure would obstruct any text or style packaging without the need to decline to change the final regulation to image appearing under it. According to adapt the warning as set out in the allow the required warnings to appear these comments, it is not technically electronic files provided in the IBR on the bottom 50 percent of the feasible to make a clear or transparent document, we plan to notify the packaging. We have determined that closure that will adhere to the package. regulated companies and the public of requiring that the warnings appear in One comment recommended that FDA this conclusion and give regulated the upper portion of the package, as amend the proposed rule to permit that companies a reasonable amount of time specified by the Tobacco Control Act, graphic warnings for soft packs appear to modify their packaging before any will result in warnings that are more at the bottom of the individual pack, or regulatory action is taken under this prominent, more salient, and more effective than warnings appearing at the to specifically allow the closures at the rule. We decline to change the final top center of the pack. The other bottom of the package. regulation to permit graphic warnings comment recommended that FDA use (Comment 181) Comments from two on ‘‘soft pack’’ style packaging to appear enforcement discretion to permit the companies raised concerns about their at the bottom 50 percent of the closure on soft packs until a ability to incorporate the required packaging. We have determined that technologically feasible solution is warnings in advertisements of varying requiring that the warnings appear in developed. sizes and shapes. These comments (Response) We recognize the the upper portion of the package, as noted that the proposed FDA rule technological difficulty of incorporating specified by the Tobacco Control Act, requires that companies maintain the the required warnings on ‘‘soft pack’’ will result in warnings that are more aspect ratio of the warnings as set forth style packaging. Given the paramount prominent, more salient, and more in the electronic files. The comments need to incorporate the warning without effective than warnings appearing at the stated that it would not be possible to obstructing any of the discrete elements bottom of the package. maintain the clarity of the warning in of the warning (i.e., the image and the (Comment 180) Two comments, from certain advertisements if companies are textual warning statement) or the a cigarette manufacturer and a tobacco required to use the 4:3 aspect ratio set reference to a cessation resource, the company trade association, noted that out in the advertisement format final rule permits companies to adapt cigarette packages are typically wrapped published with the proposed rule. One the warnings on ‘‘soft pack’’ style in clear cellophane with a tear tape company recommended that FDA packaging by moving the warning below located in the upper 50 percent of the provide warnings with different aspect the closure in accordance with the package. The tear tape permits an ratios (1:1, 1.5:1, 1:2, 2:1, and 2.5:1) to requirements included in the IBR individual to open the package, and address this concern. The other document. The IBR document states that usually is removed once the package is company recommended that FDA either this is only permitted when it is not opened for the first time. One comment eliminate the requirement that technologically feasible to incorporate stated that the cellophane tear tape will companies maintain the aspect ratios set the required warnings on ‘‘soft pack’’ obstruct the required warning when the out in the electronic files or allow style packaging without the need to cigarette package has not yet been companies to adjust the layout of the adapt the warning as set out in the opened for the first time, and warnings so long as the manufacturer electronic files provided in the IBR recommended that FDA expressly includes both the image and the textual document. The requirements included permit the use of tear tapes and require warning statement. in the IBR document allow companies that warnings for ‘‘soft pack’’ style (Response) We have revised the using ‘‘soft pack’’ style packaging only packaging appear at the bottom of the proposed IBR document and the

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electronic files provided in the final IBR within the specified areas, especially believe it is necessary to provide document include warnings designed given the variety of font styles included ‘‘printers proofs’’ for the warnings. with a variety of different aspect ratios. in the nine selected warnings. (Comment 188) One comment Specifically, the files are designed with (Comment 184) Several comments requested that FDA adopt required aspect ratios of 1:1, 1.5:1, 1:2, 2:1, and requested that FDA provide fonts for the warnings with consistent dimensions to 2.5:1. As provided in § 1141.10, the textual warning statements in each of allow for accurate incorporation into required warnings must be accurately the required warnings. manufacturers’ packages and reproduced in advertisements. (Response) For English and Spanish advertisements. Therefore, companies should choose an language warnings, the font size and (Response) We decline to adopt this aspect ratio that is appropriate for the font style is built into the electronic files recommendation. As discussed dimensions of their advertisement such provided in the IBR document. For previously, our selection of the nine that the required warning can be advertisements in foreign languages final required warnings was based in reproduced accurately once it is sized other than Spanish, companies must part on our desire for a diverse set of (i.e., expanded or compressed) to comply with the font size requirements warnings in a variety of different styles occupy the required area of the in section 4(b)(2) of FCLAA and any (e.g., photographic and illustrative, advertisement. These files will permit format requirements included in the IBR different fonts and font sizes) and companies to incorporate the required document. In all situations, it is the diversity of human images (e.g., race, warnings into their advertisements advertiser’s responsibility to ensure that gender, age) in order to reach the without significant distortion or loss of the textual statements appear in broadest range of target audiences. We clarity. conspicuous and legible type and that have determined that this variety will (Comment 182) One comment from a the required warning complies with the enhance the effectiveness of the tobacco product manufacturer format specifications set forth in section warnings and help to delay potential recommended that FDA provide 5.5 4 of FCLAA. wear out of the warnings. Because of the inch wide and 27 inch wide formats for (Comment 185) One comment diversity of styles and images, some advertisements. The comment stated requested that FDA provide instructions warnings have slightly different that expanding a required warning more on how companies should combine and dimensions than others. than 150 percent or compressing it display the images developed for use in (Comment 189) One comment down to less than 30 percent of the small advertisements less than 12 recommended that FDA provide layered original image will result in a loss of square inches with the required textual high resolution .tif or .eps files, with image clarity. The comment stated that warning statements. text supplied as a separate layer. providing required warnings in the 5.5 (Response) We recognize that the Another comment recommended that inch and 27 inch sizes will allow it to small size of these advertisements FDA provide images as .jpeg files. incorporate the warnings into the range presents additional challenges. We are (Response) The electronic files of advertisements it uses without any providing an electronic file of the included in the IBR document are built loss of clarity. graphic that must be used for warnings as .eps files, with separate layers for text (Response) The electronic files appearing in advertisements that are and images. Companies will be able to provided in the IBR document include less than 12 square inches. Companies convert the files into .jpeg files if formats for advertisements in 5.5 inch may combine the graphic and the needed. wide and 27 inch wide sizes. textual warning statement or otherwise B. Textual Statement Color Formats (Comment 183) One comment from a adjust the layout of the warning so long tobacco product manufacturer noted as each warning includes the specified In the document entitled ‘‘Proposed that FCLAA requires advertising graphic and an appropriate textual Required Warning Images’’ included in warnings to have a rectangular border warning statement. It is the advertiser’s the docket for the NPRM, FDA provided that is the width of the first down stroke responsibility to ensure that the textual two formats for each proposed required of the capital ‘‘W’’ of the word warning statement appears in warning; one with the warning ‘‘WARNING’’ in the textual warning conspicuous and legible type and that statement in white text on a black statements. The comment went on to the combined warning complies with background and one with the warning state that FDA’s various proposed the format specifications set out in statement in black text on a white required warnings have different-sized section 4 of FCLAA. background, under section 4(a)(2) and ‘‘W’s’’ in the word ‘‘WARNING,’’ and (Comment 186) Several comments (b)(2) of FCLAA. Several comments requested that FDA permit recommended that FDA require that offered suggestions regarding the use of manufacturers to apply a uniform companies reproduce the color graphics the color combinations, which we have border width across the nine required in the industry standard four-color summarized and responded to in the warnings for consistency. (CMYK) printing process. following paragraphs. (Response) The electronic files (Response) The electronic files (Comment 190) A few comments provided in the IBR document have a provided in the IBR document were suggested that FDA specify that the uniform border built into the formats for built with CMYK printing standards. required warnings on cigarette packages required warnings to be used in The directions in the IBR document and advertisements contain required advertisements. We have exercised our specify the use of CMYK printing warnings in either the white text on authority under section 201 of the standards. black background format or the black Tobacco Control Act to adjust the (Comment 187) One comment text on white background format, statutory requirement that the border of requested that FDA make available whichever the Agency chooses to most the warning be the width of the first ‘‘printers proofs’’ for each of the effectively communicate the warnings. down stroke of the letter ‘‘W’’ in the required warnings in order to ensure (Response) We disagree. Section word ‘‘WARNING’’ in the textual optimal clarity. 4(a)(2) of FCLAA states that for cigarette warning statement. A uniform border (Response) We have determined that packages, the ‘‘text shall be black on a requirement for all advertisements will the electronic files provided in the IBR white background, or white on a black ensure that the warnings are clear, document will be adequate to ensure background.’’ Similarly, for conspicuous, and legible, and appear necessary clarity. Thus, we do not advertisements, section 4(b)(2) of

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FCLAA states that the text of the rotate the required warnings for each warnings randomly and in statement in the required warning ‘‘shall brand they sell in stores. approximately equal numbers. The be black if the background is white and (Response) We decline to address this comment recommended that, for ‘‘soft white if the background is black.’’ We issue here, as it is beyond the scope of pack’’ style packages, FDA apply a interpret these statutory requirements to the current rulemaking. policy of enforcement discretion that mean that companies can use either of (Comment 194) Several comments relieves companies of the obligation to these two text/background color recommended that FDA rotate the display the nine required warnings combinations on the package or in the graphic warnings to prevent randomly and equally as long as advertisement. overexposure. The comments also noted companies have taken reasonable steps (Comment 191) One comment that different warnings will have to distribute the warnings as randomly recommended that the word ‘‘CANCER’’ different impacts on the various and equally as possible. Another always appear in red as part of the segments of the population, further comment expressed general concerns health warnings on cigarette packages emphasizing the need to rotate the about a manufacturer’s ability to comply and advertisements. warnings. with the requirement that the warnings (Response) It is unclear whether these (Response) We disagree. As stated be randomly displayed in as equal a comments were referring to the previously, section 4(a)(2) and (b)(2) of number of times as possible. quarterly rotation of the required FCLAA prescribe the colors for the Several comments requested warnings in advertisements or the need textual statements on packages and additional guidance on the filing of to refresh the warnings on a regular advertisements (e.g., white text on black warning plans, including how to hold basis. We agree that rotation of the background or black text on white parties responsible for meeting FCLAA warnings is important to delay wear out background). FDA has the authority to and the Tobacco Control Act’s rotation and to ensure that all population change the format of the textual and random display requirements. segments are exposed to the different In addition, one comment asked that statements if such a change would warnings in as equal a number of times FDA adopt a formal process for approval promote greater understanding of the as is possible. In accordance with of required warnings on packages and health risks associated with cigarette section 4(c)(2) of FCLAA, the required warning plans. Some comments from smoking. If we determine at a later date, warnings must be rotated quarterly in manufacturers suggested that, to add that requiring the word ‘‘CANCER’’ to cigarette advertisements. See section II.E predictability for companies on the appear in red font will promote a greater of this document for additional transition to the new warnings, FDA understanding of smoking’s risks, we information regarding FDA’s efforts to should consider adopting a procedure to may propose new iterations of the delay or prevent wear out. allow pre-approval or pre-submission required warnings in future (Comment 195) One comment review of cigarette packaging and advise rulemakings. recommended that FDA monitor the manufacturers of any deficiencies so the C. Random Display and Rotation of rotation of required warnings in manufacturer can remedy them before Warnings cigarette advertisements to ensure production. One comment requested compliance by all manufacturers, that FDA use Federal Trade Commission The proposed rule did not specifically distributors, importers, and retailers. (FTC) procedures for pre-approval address the statutory requirements for (Response) We agree with this review of packaging. the warnings on cigarette packages to be comment. We will monitor rotation and (Response) We have opted not to randomly displayed in each 12-month ensure compliance, which will include address these issues as part of this period and for quarterly rotation of the review and approval of warning rulemaking proceeding. Under section warnings in advertisements, under plans submitted to the Agency in 4(c) of FCLAA, warning plans must be section 4 of FCLAA. However, FDA accordance with section 4(c) of FCLAA. submitted to FDA for approval. As received several comments on this (Comment 196) One comment noted in the NPRM, we intend to issue. These comments, and FDA’s suggested that manufacturers be given separately address the requirements of responses, are included in the following broad discretion in complying with the section 4(c) of FCLAA related to the paragraphs. requirements that they include the submission of plans regarding the (Comment 192) One comment required warnings on all cigarette random display of warnings on expressed concern that cigarette packages such that in each 12-month packages and rotation in advertisements manufacturers may only use some of the period all of the different warnings (75 FR 69524 at 69538). This is still our nine new required warnings on their appear in as equal a number of times as plan, and we believe the issues raised in cigarette packages and requested that is possible on each brand of the product these comments would be better FDA require companies to use all the (see 15 U.S.C. 1333(c)). The comment addressed in that context. required warnings in equal numbers. stated that its printing machines, and in (Comment 197) One comment (Response) We agree that all cigarette particular the print cylinders, used to suggested that FDA provide sample pre- manufacturers must use all of the nine produce ‘‘soft pack’’ style packaging approved layouts for required warnings required warnings on their cigarette only allows the company to print five on cigarette packages. packages. Section 4(c)(1) and (c)(3)(B) of images per roll and does not allow for (Response) By providing the FCLAA expressly requires that the nine warnings to be die cut and collated. electronic files of the required warnings, required warnings must be randomly Because ‘‘soft pack’’ style packaging we are providing formats that the displayed in as equal a number of times only accounts for about 10 percent of all companies must use for their packages. as possible on each brand of cigarette packages distributed and sold, this style The final rule includes a document product and be randomly distributed in of packaging frequently is printed in incorporated by reference, entitled all areas of the United States so that all small batches and for some, is printed ‘‘Cigarette Required Warnings,’’ which of the required warnings appear in the only once per year. The comment stated contains the final images to be required marketplace at the same time. that in light of these production on cigarette packages. Cigarette (Comment 193) One comment constraints, it would be impossible to manufacturers also should refer to recommended that retailers be apply and distribute ‘‘soft pack’’ style § 1141.10(a), which mandates that the exempted from any requirement to packages displaying the nine required required warnings be on the top 50

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percent of both the front and back of the 201 of the Tobacco Control Act modifies summarized and responded to in the cigarette packages. section 4 of FCLAA to require that nine following paragraphs. (Comment 198) One comment new health warning statements appear (Comment 199) Several comments requested that FDA issue a tobacco on cigarette packages and in cigarette from the tobacco industry, advertising product advertising guide for industry. advertisements and to require that ‘‘the industry associations, and private This comment noted that while product Secretary [of Health and Human citizens expressed concern that the labeling and advertising present some Services] shall issue regulations that graphic warning requirements proposed similar issues, there are specific issues require color graphics depicting the by FDA violate the First Amendment of that relate solely to advertising negative health consequences of the United States Constitution. communications with consumers. smoking’’ to accompany the nine new Specifically, comments alleged that the Another comment suggested that FDA health warning statements. proposed required warnings are should issue separate advertising Under section 4(d) of FCLAA (as unconstitutional because, rather than guidance for industry that includes amended by section 201(a) of the conveying factual information to recommendations for display of Tobacco Control Act), FDA may adjust consumers, they contain ‘‘disturbing,’’ required warnings in each common the type size, text, and format of the ‘‘lurid’’ images that are designed to advertising form. required warnings as FDA determines elicit emotions, such as ‘‘loathing, One comment stated that FDA should appropriate so that both the textual disgust, and repulsion.’’ Thus, the require that cigarettes displayed at the warning statements and the comments state, they force tobacco point of sale should be required to be accompanying graphics are clear, companies to ‘‘stigmatize their own displayed in a manner so that the conspicuous, and legible and appear products’’ and compel them to convey graphic warnings are visible. within the specified area. Furthermore, the government’s ‘‘ideological message’’ One comment submitted on behalf of section 202(b) of the Tobacco Control that ‘‘the risks associated with smoking several nonprofit organizations Act amends section 4 of FCLAA to cigarettes outweigh the pleasure that suggested that FDA modify proposed permit FDA to, after notice and an smokers derive from them’’ and that no § 1141.10 to include two paragraphs opportunity for the public to comment, one should use these lawful products. regarding the use of images of cigarette adjust the format, type size, color The comments also asserted that the packs in advertisements and in other graphics, and text of any health warning warning requirements are unjustified communications. They requested that statement if such a change would because the health risks of smoking are FDA add one paragraph to state that any promote greater public understanding of already well known, and that they are image of a cigarette pack in an the risks associated with the use of unduly burdensome because the size advertisement must include a required tobacco products. and positioning requirements for the warnings on packages and warning on the cigarette pack image. In In addition, provisions of the FD&C advertisements would effectively rule addition, they requested that FDA add Act provide authority to require out the companies own attempts to a paragraph to state that no disclosures. For example, section 906(d) convey information about their manufacturer, importer, distributor, or of the FD&C Act (21 U.S.C. 387f(d)) retailer may alter any image used to products. For these reasons, the authorizes FDA to issue regulations comments asserted that the graphic depict cigarette packs as legally restricting the sale or distribution of distributed or sold to consumers in any warning requirements constitute cigarettes and other tobacco products, compelled speech regulation that is public communication (including, but including restrictions on the advertising not limited to, movies, Web sites, and content-based and presumptively and promotion of such products, if FDA invalid and that the requirements can television programs) so that the required determines the restriction is appropriate warning on the cigarette pack image is only be upheld if they satisfy strict for protecting the public health. scrutiny, i.e., if they further a removed or obscured in any way. These requirements are supplemented (Response) We recognize that the compelling government interest by the by the FD&C Act’s misbranding least restrictive means available. The range of advertising materials covered provisions, which require that product by the new graphic warning rules may comments stated that the graphic advertising and labeling include proper warning requirements cannot satisfy create additional complexities. As stated warnings (see 21 U.S.C. 321(n); previously, we intend to issue separate this standard because they will have no 387c(a)(1), (a)(7)(A), (a)(7)(B), and material impact on consumers’ beliefs regulatory documents to provide (a)(8)(B)). In addition, under section information on compliance with the about the health risks of smoking or on 701(a) of the FD&C Act (21 U.S.C. smoking behavior and because the random display and rotation 371(a)), FDA has authority to issue requirements. We will consider whether government bypassed less speech- regulations for the efficient enforcement restrictive alternatives in favor of the any other actions that are within the of the FD&C Act. scope of our authority under the requirements. While we did not receive comments The comments from the tobacco Tobacco Control Act may be warranted, regarding our authority to issue these industry also stated that the warning such as addressing requests for regulations under the provisions requirements violate the First additional guidance regarding referenced in the previous paragraphs, Amendment because they restrict advertising or suggested regulatory we did receive comments regarding the tobacco companies’ speech. They stated changes. constitutionality of the warning that requiring the warnings to occupy VII. Legal Authority and Responses to requirements, which are summarized the top 50 percent of the front and back Comments and responded to in sections VII.B and display panels of cigarette packages and VII.C of this document. the top 20 percent of cigarette A. FDA’s Legal Authority advertisements impairs the B. First Amendment Commercial As set forth in the preamble to the communication value of the tobacco Speech Issues proposed rule (75 FR 69524 at 69524 product manufacturers’ trademarks and through 69525), the Tobacco Control FDA received several comments trade dress and narrows their avenues of Act provided FDA with the authority to related to First Amendment commercial communications with adult smokers, regulate tobacco products, and section speech issues. These comments are which are already limited because of the

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Master Settlement Agreement and the advertising, and other channels. In requirements are subject to ‘‘less other requirements of the Tobacco addition, the comment stated that the exacting scrutiny’’ than affirmative Control Act. Indeed, one of the warning requirements do not offend limitations on speech)). ‘‘Commercial comments argued that relegating manufacturers’ First Amendment rights disclosure requirements are treated tobacco companies’ message to the because the required warnings are differently from restrictions on bottom half of cigarette packages would factual disclosures that accurately commercial speech because mandated render their speech on packaging depict the real consequences of smoking disclosure of accurate, factual, ‘‘wholly ineffective’’ and that the cigarettes and the benefits and commercial information does not offend collective requirements with respect to importance of quitting. The comment the core First Amendment values of packaging and advertisements would asserted that the warning requirements promoting efficient exchange of ‘‘effectively rule out’’ the companies’ support the public interest by providing information or protecting individual attempts to convey information about consumers with truthful information liberty interests’’ (Nat’l Electric their products to consumers. The that is helpful in making informed Manufacturers Ass’n v. Sorrell, 272 F.3d comments asserted that the warning purchasing decisions. The comment 104, 113–14 (2d Cir. 2001), cert. denied, requirements do not satisfy the test also stated that the government 536 U.S. 905 (2002)). Instead, such governing restrictions on commercial constitutionally regulates the disclosure advances ‘‘the First speech articulated by the Supreme advertising and labeling for a wide Amendment goal of the discovery of Court in Central Hudson Gas & Electric variety of industries in the interest of truth and contributes to the efficiency of Corp. v. Public Service Commission, 447 providing consumers with accurate the ‘marketplace of ideas’ ’’ (Id. at 114). U.S. 557 (1980), which requires that information about products that affect ‘‘Protection of the robust and free flow government restrictions on commercial their health and that no product affects of accurate information is the principal speech directly advance a substantial consumers’ health more than cigarettes. First Amendment justification for government interest and be no more Finally, one comment stated that protecting commercial speech’’ (Id.). extensive than necessary to serve that requiring warnings for cigarettes is well The nine new health warning interest. Similar to their assertions with established legally and that the addition statements and the accompanying respect to compelled speech, the of graphic images to the warnings graphic images selected by FDA convey comments asserted that, to the extent represents a difference in form that will information that is factual and that the warning requirements restrict not change the fundamental message uncontroversial. Therefore, the warning speech, they do not pass muster under content of the warnings. As a result, the requirements are subject to the the First Amendment because they will comment concluded that there is no ‘‘reasonable relationship’’ test in have no material impact on consumers’ constitutional basis to delay the Zauderer, rather than strict scrutiny as beliefs about, or understanding of, the implementation of the warning suggested by some of the comments. The comments do not dispute that the health risks of smoking or on smoking requirements. warning statements are true. Indeed, as behavior, and because the government (Response) We have carefully detailed in the NPRM and in section bypassed less speech-restrictive considered these comments and we II.A.2 of this final rule, there is alternatives in favor of the requirements. disagree that the warning requirements violate the First Amendment under substantial scientific evidence to Other comments, including comments either of the theories set forth in the support the information conveyed in the from a law firm, a public health comments. To the extent that the new required warnings. The NPRM advocacy group, and a private citizen, warning requirements compel summarizes a large body of scientific disagreed that the warning requirements commercial speech, they are permissible evidence showing that cigarettes cause a violate the First Amendment. under Zauderer v. Office of Disciplinary wide range of negative health Specifically, two comments noted that Counsel of Supreme Court of Ohio, 471 consequences, including various types the warning requirements have been U.S. 626 (1985), and to the extent that of cancer; all the major cardiovascular upheld by a Federal court in they restrict commercial speech, they diseases, including heart disease and Commonwealth Brands v. United States, satisfy the Central Hudson stroke; COPD and other respiratory 678 F. Supp. 2d 512, 529–32 (W.D. Ky. requirements. diseases; and a variety of negative 2010), appeal pending sub nom., The Warning Requirements health effects in infants born to women Discount Tobacco City & Lottery, Inc. v. Permissibly Compel Disclosure of who smoke and in nonsmokers exposed United States, Nos. 10–5234 & 10–5235 Factual Information. The comments do to secondhand smoke (75 FR 69524 at (6th Cir.). One comment noted that the not dispute that required warnings and 69527 through 69529). The NPRM also court rejected an argument that the new other disclosure requirements ‘‘trench sets forth scientific evidence describing warnings required under the Tobacco much more narrowly on an advertiser’s the negative effects of nicotine addiction Control Act are too large and too interests than do flat prohibitions on and the major and immediate health prominent and stated that Congress has speech’’ and may appropriately be benefits of smoking cessation (75 FR made findings with respect to the required ‘‘in order to dissipate the 69524 at 69528 through 69529). As the required size of the warnings, their possibility of consumer confusion or court in Commonwealth Brands placement on packages and deception’’ (Zauderer, 471 U.S. at 651 correctly observed, the content of the advertisements, and the text of the (citation omitted)). Accordingly, warnings ‘‘is objective and has not been warnings based on a substantial record. regulations that compel ‘‘purely factual controversial for many decades’’ The comment also stated that Congress’ and uncontroversial’’ commercial (Commonwealth Brands, 678 F. Supp. findings are supported by the speech are subject to more lenient 2d at 531). voluminous authority cited in FDA’s review than regulations that restrict The images we have selected to NPRM. Another comment stated that, accurate commercial speech and will be accompany the nine warning statements although tobacco companies will have sustained if they are ‘‘reasonably also convey information that is factual to redesign their packages as a result of related’’ to the government’s asserted and uncontroversial regarding the the warning requirements, they will still interest (Id.; see also Milavetz, Gallop & negative health consequences of be able to communicate with their Milavetz, P.A. v. United States, 130 S. smoking. These images are consistent customers through packaging, Ct. 1324, 1339 (2010) (disclosure with the information conveyed in the

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accompanying textual warning accompanies the warning statement, consequences of smoking, the effects statements; each image depicts themes ‘‘Smoking during pregnancy can harm shown in the photographs are, in fact, and subjects that provide visual context your baby.’’ As set forth in the NPRM, accurate depictions of the effects of for the textual warning statements. The there is ample evidence to show that sickness and disease caused by images also play a crucial role in the smoking during pregnancy has negative smoking, and the comments did not communication of the textual warning effects, including increasing rates of dispute this fact. information; as discussed extensively in preterm delivery and shortened As one of the comments noted, the the NPRM, the addition of graphic gestation and increasing the likelihood addition of graphics to warnings for images to health warning messages of low birth weight infants, among other cigarettes is a difference in form only causes consumers to notice and attend things (75 FR 69524 at 69528). Thus, the and does not change the fundamental to the warning information in the first image ‘‘baby in incubator’’ accurately content of the messages, which convey instance, and increases recall of the depicts the health consequences factual information about the health warning message and the depth of smoking during pregnancy can have for consequences of smoking. The court in cognitive processing of the message (75 infants born to mothers who smoke. The Commonwealth Brands was correct FR 69524 at 69531). style of the depiction—here, a graphic when it stated that it ‘‘does not believe The comments did not dispute that illustration—does not make it less that the addition of a graphic image will the images proposed to accompany the factual. The style is just a means to alter the substance of such [warning] warning statements accurately depict convey the information. messages, at least as a general rule’’ the negative health consequences of The remaining images we have (Commonwealth Brands, 678 F. Supp. smoking. Rather, they faulted our selected also factually depict the 2d at 532). Rather, these images alter the proposed images for being ‘‘disturbing’’ negative health consequences of effectiveness of the warnings by or eliciting emotions. For example, one smoking when viewed in context with enhancing their ability to communicate of the comments cited as disturbing their accompanying warning statements. factual information to consumers. several of the images selected by FDA in As explained in section III of this Despite the factual nature of the this rule, including the images entitled document, the image ‘‘smoke messages conveyed by the required ‘‘hole in throat,’’ depicting a man approaching baby’’ accompanying the warnings as described previously, some smoking through a tracheostomy statement ‘‘WARNING: Tobacco smoke comments asserted that the opening; ‘‘healthy/diseased lungs,’’ can harm your children’’ effectively government’s goal is to force cigarette depicting healthy lungs juxtaposed with conveys the factual message that companies to stigmatize their products lungs damaged by smoking; ‘‘cancerous exposure to tobacco smoke is harmful by including the government’s lesion on lip,’’ depicting a lesion for children by realistically showing a ideological, antismoking message on consistent with that caused by oral baby being exposed to secondhand their packages and advertisements. cancer; and ‘‘man with chest staples,’’ smoke. The image ‘‘oxygen mask on These comments claimed that the size of depicting a man with an autopsy scar. man’s face,’’ which accompanies the the warnings and the FDA study The comment did not assert, however, statement ‘‘WARNING: Cigarettes cause endpoints assessing consumers’ that the effects shown in the images are strokes and heart disease,’’ accurately emotional and cognitive reactions to the false, i.e., that they are not depicts a typical intervention for a required warnings and whether the manifestations of negative health patient suffering acute cardiac distress warnings were ‘‘difficult to look at,’’ consequences of smoking, such as or stroke. The image ‘‘woman crying,’’ belie any suggestion that they are purely throat, lung, and oral cancer, and death. which is paired with the statement factual. The fact that the images are disturbing ‘‘WARNING: Tobacco smoke causes We disagree with these comments. or evoke emotion does not mean that fatal lung disease in nonsmokers,’’ is a The size of the warnings and their they are not factual representations of realistic portrayal of the emotional ability to evoke cognitive and emotional the effects of smoking. In fact, the suffering experienced as a result of responses are consistent with the severe, life-threatening and sometimes disease caused by secondhand smoke government’s interest in ensuring that disfiguring health effects of smoking exposure. Finally, the image ‘‘man I the required warnings effectively conveyed in the required warnings are Quit t-shirt,’’ which is paired with the communicate factual information about disturbing and the images we have statement ‘‘WARNING: Quitting the negative health consequences of selected appropriately reflect this fact. smoking now greatly reduces serious smoking to consumers. The NPRM (75 As such, it is not surprising that the risks to your health,’’ realistically FR 69524 at 69531 through 69534) and warnings regarding the negative health portrays an image of a man that is section II.D of this final rule summarize consequences of smoking would evoke consistent with and supportive of this the significant research literature emotions such as fear of being stricken factual warning statement, although, supporting FDA’s conclusion that larger, with life-threatening cancer or disgust at unlike the other required warnings, this graphic warnings more effectively what it might be like to have that warning is framed in a positive manner communicate health risks to consumers happen. If the required warnings failed (i.e., it conveys factual information than the existing smaller, text-only to elicit emotional reactions, they would about the negative health consequences warnings on cigarette packages and in also fail to communicate the described of smoking by educating consumers advertisements. negative health consequences of about the positive health consequences Likewise, our decision to use images smoking in a truthful, forthright of refraining from smoking). that elicit strong cognitive and manner. The comments also asserted that some emotional responses is consistent with Some comments also stated that ‘‘non- of the proposed images, including some established models of risk factual cartoon images’’ proposed by now selected by FDA in this final rule, communication. Our research study FDA remove any doubt that the appear to use technologically-enhanced included three measures to assess the proposed warnings convey an photographs to emphasize the effects of salience (i.e., noticeability and ideological message. For this final rule, sickness and disease. While we readability) of the proposed required one of the images we have selected is, acknowledge that some of the warnings: Emotional reactions, indeed, a graphic illustration. That photographs were technologically cognitive reactions, and whether the image shows a ‘‘baby in incubator’’ and modified to depict the negative health warning was difficult to look at. Use of

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these measures is well-established in Both the research literature and FDA’s they cite Ibanez v. Florida Department the scientific literature. As discussed in study of the proposed required warnings of Business and Professional Regulation, the study report (Ref. 49, study report) indicate that the required warnings are 512 U.S. 136 (1994), and International and in comments discussed in section effective at communicating the health Dairy Foods Ass’n v. Boggs, 622 F.3d III of this document, risk information is consequences of smoking to consumers. 628 (6th Cir. 2010), for the proposition most readily conveyed by warnings that We have cited extensive literature in the that courts have found disclosure elicit strong responses on these NPRM and in section II.D of this final requirements to be unjustified where the measures—eliciting strong emotional rule discussing the greater effectiveness possibility that disclosure will prevent and cognitive reactions to graphic of larger, graphic warnings over the consumer confusion is only speculative. warnings enhances recall and current warnings at getting consumers’ We disagree with these comments. As information processing, which helps to attention (see 75 FR 69524 at 69531 discussed in section II.C of this ensure that the warnings are better through 69532). For example, in one document, there is significant evidence understood and remembered. These study in which students were shown to show that consumers lack knowledge responses in turn influence short-term images of the Canadian graphic about or underestimate the health risks outcomes, such as later recall of the warnings and the current warnings in of smoking. Examples of such evidence message and changes in knowledge, use in the United States, the Canadian include: A 2007 survey that found that attitudes, and beliefs related to the graphic warnings significantly increased two in three smokers underestimate the dangers of tobacco use and exposure to aided recall of the warnings, increased chance of developing lung cancer; secondhand smoke, and eventually lead depth of message processing, and several studies in which only a minority to long-term changes in behavior. Thus, increased the perceived strength of the of smokers surveyed believed that they contrary to the comments discussed message (75 FR 69524 at 69531, citing were at increased risk for cancer and previously, our use of these reaction Ref. 97). In addition, as discussed in heart disease; various studies indicating measurements does not demonstrate the section III of this document, FDA’s that Americans who are aware of certain Agency’s intent to stigmatize tobacco study report (Ref. 49) demonstrates that risks, such as cancer, are unaware of the products. Rather, these measures are eight of the nine required warnings many other health risks associated with appropriate indicators of how selected for the final rule showed highly smoking; surveys showing that young effectively health warning messages are significant effects relative to the text- adults do not appreciate the addictive communicated, and were used in FDA’s only control on all the salience nature of cigarettes; studies showing research study to provide valuable measures (emotional reaction scale, that knowledge of smoking risks is even information regarding the relative cognitive reaction scale, and difficult to lower among certain demographic ability of the 36 proposed required look at measure) across all of the target groups, such as people with lower warnings to effectively convey the very audiences (youth, young adults, and incomes and fewer years of education; real adverse health consequences of adults). The ninth warning, which and research demonstrating that smoking to the public. communicates the message that Americans grossly underestimate the Indeed, the court in Commonwealth ‘‘Quitting smoking now greatly reduces effects of secondhand smoke on Brands rejected an argument that the serious risks to your health,’’ also nonsmokers (see section II.C of this purpose of the new, larger warnings showed strong effects relative to the document for more extensive discussion with their graphic image component is text-only control, with significant effects of this research). to ‘‘browbeat potential tobacco in at least some audiences on the In addition, we included in the NPRM consumers’’ with the government’s emotional and cognitive reaction scales. an extensive discussion of how the antismoking message. The court stated Again, these results with respect to the current cigarette warnings have gone that ‘‘the government’s goal is not to salience measures are important because unnoticed and fail to appropriately stigmatize the use of tobacco products they have been shown to enhance recall convey crucial information to on the industry’s dime; it is to ensure and information processing, which consumers about the health risks of that the health risk message is actually helps to ensure that warnings are better smoking (75 FR 69524 at 69525 and seen by consumers in the first instance’’ understood and remembered. 69529 through 69531). For example, in (Commonwealth Brands, 678 F. Supp. As set forth previously, to the extent 1994, the Surgeon General reported that 2d at 530 (emphasis in original)). We that the warning requirements compel the current warnings, which have been agree with these findings of the district speech, they are permissible under required on cigarette packages and in court. Zauderer because they require cigarette advertisements for many years, Because the warning requirements disclosure of factual information and are are given little attention or compel the disclosure of information reasonably related to FDA’s goal of consideration by viewers (75 FR 69524 that is purely factual and effectively communicating the health at 69525). The same report found that noncontroversial, they are permissible consequences of smoking to consumers. warnings on billboard advertisements under Zauderer if they are reasonably Accordingly, it is not necessary to were so small that passing motorists related to the government’s asserted address the strict scrutiny analyses set could read them only with ‘‘great interest. As stated repeatedly in the forth in the comments. difficulty’’ (see also the discussion of NPRM and this rule (see, e.g., section We are not persuaded to the contrary billboard advertisements at 75 FR 69524 II.D of this document), the Agency’s by the comments’ assertions that the at 69525). Likewise, as noted in section primary interest is to effectively convey warning requirements are unjustified I.A of this document, a major study into the negative health consequences of and unduly burdensome. The industry tobacco policy in the United States by smoking on cigarette packages and in comments discussed previously the IOM in 2007 concluded that U.S. advertisements, a necessary part of contended that the warnings are package warnings are both ‘‘unnoticed which, as the court in Commonwealth unjustified because the health risks of and stale’’ and found that they fail to Brands recognized, is ‘‘to ensure that the smoking are already universally known communicate relevant information in an health risk message is actually seen by and overestimated and the FDA study effective way (Ref. 3 at 291). The Chair consumers in the first instance.’’ The results show that the required warnings of the IOM’s Committee on Reducing warning requirements are clearly will have no impact on smoking beliefs Tobacco Use described the warnings on reasonably related to this interest. or behavior. To support their argument, cigarette packs as ‘‘invisible’’ in

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testimony in 2007 on a precursor to Equally unavailing is the assertion for that end, lest [a court] infringe on what was enacted as the Tobacco that the warning requirements are traditional legislative authority to make Control Act (75 FR 69524 at 69530). unduly burdensome because the predictive judgments when enacting Research regarding warning statements required size and positioning of nationwide regulatory policy’’ (Id. at in cigarette advertisements has shown warnings on packages and in 196). Thus, ‘‘the question is not whether similar results (Id., and studies cited advertisements effectively rule out Congress, as an objective matter, was therein). As discussed in the NPRM, the tobacco companies’ own attempts to correct’’ in its determinations (Id. at IOM expressed concern about the ability convey information. Because this part of 211). ‘‘Rather, the question is whether of consumers with less education to the compelled speech argument the legislative conclusion was recall the information included in text- overlaps with the assertion that the reasonable and supported by substantial based messages. The IOM further warning requirements restrict speech in evidence in the record before Congress’’ explained that smokers are more likely violation of the First Amendment, it is (Id.). to recall larger warnings as well as addressed in the following paragraphs. Comments from tobacco product warnings that appear on the front of The Warning Requirements Are manufacturers argued that the warning packages instead of the side, as is the Permissible Under Central Hudson. To requirements restrict tobacco case for the current warnings (75 FR the extent that the challenged companies’ speech because the 69524 at 69531). As the court in provisions restrict commercial speech, warnings must occupy the top 50 Commonwealth Brands likewise the restrictions are analyzed under the percent of the front and back display concluded, the evidence before framework established in Central panels of cigarette packages and 20 Congress clearly demonstrates that the Hudson Gas & Electric Corp. v. Public percent of the area of cigarette new warning requirements are justified Service Commission, 447 U.S. 557 advertisements. They stated that these (678 F. Supp. 2d at 530–31). (1980). ‘‘The First Amendment’s size and positioning requirements are Substantial evidence showing concern for commercial speech is based unduly burdensome and will consumer ignorance regarding the on the informational function of significantly impair their ability to health risks of smoking and the advertising’’ (Id. at 563). Consequently, convey information about their products ineffectiveness of the current warnings there is no protection for ‘‘commercial to adult consumers. In essence, their at communicating such risks clearly messages that do not accurately inform argument is that the new warnings are supports the need for the required the public about lawful activity’’ or that too large and too prominent, which, as warnings. The results of our research are ‘‘related to illegal activity’’ (Id. at recognized by some of the comments study showing significant effects on 563–64). If the communication is discussed previously, has already been salience measures for all of the required neither misleading nor related to rejected by the court in Commonwealth warnings, along with the substantial unlawful activity, the government may Brands (see Commonwealth Brands, 678 international evidence showing that impose restrictions that directly F. Supp. 2d at 531). larger, graphic warnings effectively advance a substantial government It is important to note that the communicate health risks, demonstrate interest and are not more extensive than comments did not identify any specific that, unlike the disclosures in the cases is necessary to serve that interest (Id. at statements that will be restricted by the cited in the comments, the required 566). That standard does not require the warning requirements. Nonetheless, we warnings will have more than a legislature to employ ‘‘the least will assume for the purpose of argument speculative effect on consumer restrictive means’’ of regulation or to that any speech that possibly could be 7 restricted as a result of this rule would confusion about the risks of smoking. achieve a perfect fit between means and be nonmisleading and relate to lawful ends (Board of Trustees v. Fox, 492 U.S. 7 In Zauderer, the asserted government interest activity and, thus, would be commercial 469, 480 (1989)). It is sufficient that the was preventing consumers from being misled by a speech protected by the First legal advertisement, and thus, the Court noted that legislature achieve a ‘‘reasonable’’ fit by warnings or disclaimers could be appropriately Amendment. adopting regulations ‘‘‘in proportion to The comments did not dispute that required ‘‘in order to dissipate the possibility of the interest served’’’ (Id., quoting In re consumer confusion or deception’’ (Zauderer, 471 the government has a substantial U.S. at 651 (citations omitted)). In articulating the R.M.J., 455 U.S. 191, 203 (1982); accord interest in effectively communicating applicable level of First Amendment scrutiny for Pagan v. Fruchey, 492 F.3d 766, 771 the health risks of smoking to the public disclosure requirements, the Court stated that such (6th Cir. 2007) (en banc)). or, as the court in Commonwealth requirements must be ‘‘reasonably related to the The Supreme Court has emphasized State’s interest in preventing deception of Brands characterized it, in ‘‘ensur[ing] consumers’’ (Id.). However, appellate courts have that ‘‘[t]he Constitution gives to that the health risk message is actually held that Zauderer’s holding was not limited to Congress the role of weighing disclosure requirements that addressed potentially seen by consumers in the first instance’’ conflicting evidence in the legislative (Id. at 530). This substantial interest deceptive advertising, but rather applied to process’’ (Turner Broadcasting System, disclosures aimed at better informing consumers satisfies the first step of the Central about the products that they purchase (see Sorrell, Inc. v. FCC, 520 U.S. 180, 199 (1997)). Hudson analysis. 272 F.3d at 115 (applying the Zauderer standard ‘‘Even in the realm of First Amendment With respect to the second step, we and upholding a disclosure statute aimed at questions where Congress must base its increasing consumer awareness of the presence of have repeatedly discussed in the NPRM mercury in various products because the statute’s conclusions upon substantial evidence, and this final rule evidence goal was consistent with the policies underlying deference must be accorded to its demonstrating that the required First Amendment protection of commercial speech findings as to the harm to be avoided warnings will directly advance that and the distinction between compelled and and to the remedial measures adopted restricted commercial speech); see also New York interest. Such evidence includes the State Restaurant Assoc. v. New York City Board of FDA study results showing significant Health, 556 F.3d 114, 133–36 (2d Cir. 2009) Thus, even if there were no consumer confusion effects on salience measures for all of (upholding under Zauderer a requirement that regarding the health risks of smoking that needed restaurants disclose calorie content on menus to be addressed by the required warnings, the the nine required warnings (see section because it was reasonably related to the city’s goal government would still have an interest in updating III of this document) and the of reducing obesity); Pharm. Care Mgmt. Ass’n v. the warnings and better informing consumers about international experience demonstrating Rowe, 429 F. 3d 294, 310 n. 8 (1st Cir. 2005) (stating the effects of the products that they purchase— the enhanced communication value of that the court did not find any cases limiting particularly products such as cigarettes, which have Zauderer to ‘‘potentially deceptive advertising such a significant impact on health. Accordingly, larger, graphic warnings (see 75 FR directed at consumers’’)). the Zauderer standard would still apply. 69524 at 69531 through 69533). It also

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includes studies showing the improved of larger, graphic health warnings on of the larger warnings, even though they effectiveness of Canada’s larger, graphic smoking beliefs and behavior, which we have complied with similar warnings at communicating health risks. summarized in the NPRM (75 FR 69524 requirements in other countries for For example, national surveys at 69531 through 69534). years. The tobacco companies retain conducted on behalf of Health Canada Finally, the comments stated that the more than half of their cigarette indicate that approximately 95 percent warning requirements do not satisfy the packaging and 80 percent of their of youth smokers and 75 percent of third step of the Central Hudson test advertisements for their own adult smokers report that the Canadian because the mandated size and commercial speech. pictorial warnings have been effective in positioning of the warnings on packages Moreover, extensive disclosure providing them with important health and advertisements will effectively rule requirements are by no means unique to information (see Ref. 3 at p. 294). In out tobacco companies’ ability to cigarettes. For example, for products another study of adult smokers, more convey information about their such as pain relievers, certain allergy than half of the study participants products. They stated that the medications, and products to treat a reported that the pictorial warnings requirements are more extensive than variety of cold symptoms, the required made them think about the health risks necessary to achieve the government’s warnings together with other FDA- of smoking (Ref. 44). A study comparing interests and suggested that less-speech required information typically Canadian and United States warnings restrictive alternatives, including encompass more than 50 percent of the found that while ‘‘83 percent of alternatives to the warning size and product packaging.8 Canadian students mentioned health positioning requirements included by For these reasons, ‘‘the warning warnings in a recall test of cigarette Congress in the Tobacco Control Act, requirement is sufficiently tailored to packages,’’ only ‘‘7 percent of U.S. would be equally as effective. advance the government’s substantial students’’ did the same (see Ref. 3 at C– The comments provided no basis for interest under Central Hudson’’ (Id. at 3 to C–4). setting aside Congress’ judgment as to 532). The comments that argued that the the appropriate specifications. As the The reliance by two comments on the warning requirements are court in Commonwealth Brands Seventh Circuit’s decision in unconstitutionally restrictive ignored explained, Congress considered Entertainment Software Association v. this evidence. Instead, they suggested extensive evidence, starting with the Blagojevich, 469 F.3d 641 (7th Cir. that, to satisfy this step, FDA’s research 1994 Surgeon General’s Report and 2006), does not persuade us to the study would have to have shown a ending with the 2007 IOM Report, contrary. In that case, the court material impact on consumers’ beliefs which is discussed in the NPRM (75 FR invalidated a State law requiring video- about, or understanding of, the health 69524 at 69530), demonstrating that the game retailers to place a four-square- risks of smoking or smoking behavior. existing warnings are ‘‘unnoticed’’ and inch label with the numerals ‘‘18’’ on We disagree. The evidence showing ‘‘stale’’ and decided that the content and any ‘‘sexually explicit’’ video game. that the required warnings will directly format of the warnings needed to be Unlike here, the court concluded that advance the government’s primary goal revised (Commonwealth Brands, 678 F. the sticker ‘‘communicates a subjective of effectively communicating the Supp. 2d at 530–31). In so doing, and highly controversial message—that negative health consequences of Congress chose specifications for the the game’s content is sexually explicit,’’ smoking by first ensuring that the warnings that accord with FCTC, which a term capable of multiple definitions, warnings will be seen and processed by calls for warnings that ‘‘shall be and expressly rejected the comparison consumers is sufficient to satisfy the rotating,’’ ‘‘shall be large, clear, visible to the ‘‘surgeon general’s warning of the second step of Central Hudson. A and legible,’’ ‘‘should be 50% or more carcinogenic properties of cigarettes, the showing with respect to other goals, of the principal display areas but shall analogy the State attempts to draw’’ (Id. such as impacts on consumer beliefs or be no less than 30% of the principal at 652). ‘‘Applying strict scrutiny,’’ the display areas,’’ and ‘‘may be in the form smoking behavior, is not necessary for court noted that ‘‘[t]he State has failed purpose of this analysis. However, we of or include pictures or pictograms’’ to even explain why a smaller sticker note that there is significant evidence (FCTC art. 11.1(b)). The FCTC has been would not suffice’’ (Id.). Here, by that these goals will also be advanced by signed by the United States and ratified contrast, Congress has required accurate the warning requirements. by 167 countries. As the Commonwealth and objective warnings in a format that The comments repeatedly cited to Brands court correctly found, ‘‘Congress accords with the provisions of the FDA’s study report to support the also informed its warning requirements FCTC, to which the United States is a proposition that the required warnings by looking at the use of a nearly signatory, and whose effectiveness has will have no effect on consumer beliefs identical warning requirement in been demonstrated by international or behavior. However, such an assertion Canada’’ (Commonwealth Brands, 678 experience, after concluding existing, fails to take into account the study F. Supp. 2d at 531). Like the required design and the extensive evidence in the warnings, the Canadian warnings yet smaller, warnings were ineffective at literature indicating that the required occupy the top half of the two main conveying important health warnings will positively impact beliefs panels of cigarette packages. information. and behavior. As we note in section III Thus, Congress based its legislative We also disagree with the assertion in of this document, it is not surprising decision to revise the warnings in the the comments that the warning that the proposed required warnings, as first instance and to mandate certain requirements fail to meet the third step a whole, did not elicit strong responses size and placement specifications for of Central Hudson because the on the beliefs and intentions measures the warnings on substantial evidence in government failed to consider numerous because study participants had only a the record. At this time, we do not less speech-restrictive alternatives. One single exposure to one warning; the intend to change those specifications. of the comments suggested that the study was not designed to show long- Although comments from tobacco government disseminate information term effects on behavior. However, the companies asserted that the larger size 8 See 21 CFR 201.66; see also http:// study cannot be viewed in isolation leaves inadequate room for their own www.accessdata.fda.gov/drugsatfda_docs/label/ from the overall body of scientific commercial messages, they identified no 2009/022032s003lbl.pdf (example of packaging for evidence regarding the positive effects information that is suppressed by virtue OTC heartburn medication).

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about health risks as one alternative for comprehensive regulation of the tobacco Instead of advocating a subjective communicating health risks to industry. That decision seems eminently policy message as suggested by the consumers. However, government reasonable, too, since every other tool in the comment, including a cessation dissemination of the message already government’s arsenal is made less effective resource on required warnings will and more costly by Plaintiffs’ use of occurs—for example, HHS currently has advertising ‘‘to stimulate underage demand.’’ provide factual information for the several hundred tobacco-related Web (Government’s Response, p. 40). Accordingly, many smokers who have already sites, which provide informative the Court rejects Plaintiffs’ contention that developed a desire to quit, either prior messages regarding, for example, the the existence of ‘‘numerous obvious non- to or after viewing the health risk harmful effects of tobacco use (Ref. 89), speech-restrictive alternatives’’ renders the information in the required warnings. and CDC’s Office on Smoking and Act’s speech restrictions unconstitutional for The reference is designed to inform Health funds health departments in all lack of tailoring. (678 F. Supp. 2d at 538). such smokers and others that a resource 50 states, the District of Columbia, and For all of the reasons set forth in the exists that can help smokers to quit and seven U.S. territories for comprehensive previous paragraphs, we conclude that to inform them how they can access that tobacco prevention and control and the warning requirements do not violate resource. The factual nature of this provides access to tobacco control the First Amendment. information is underscored by our (Comment 200) One tobacco industry advertising material for use in this explanation in the NPRM that the comment also claimed that requiring a comprehensive effort (see Ref. 98). Agency’s goal is ‘‘to provide a place reference to a cessation resource in the However, as discussed in section II.C of where smokers and other members of required warnings would violate the this document, evidence shows that the the public can obtain smoking cessation First Amendment because it is health risks are still misunderstood or information from staff trained compelled speech that does not convey underestimated by consumers. specifically to help smokers quit by factual information about the product Moreover, government advertising delivering unbiased and evidence-based that is being sold. This comment cannot take the place of displaying information, advice, and support’’ (75 claimed that requiring a cessation effective warnings on product FR 69524 at 69540 (emphasis added)). resource communicates a subjective packaging, which ‘‘can provide a clear, In addition, our adoption of detailed policy message that consumers should visible vehicle to communicate risk at criteria designed to ensure that the not buy or use the product. the most crucial time for smokers and resource’s information, advice, and (Response) We disagree. As explained support are unbiased and evidence- potential smokers’’—the very instant previously, the requirement in this rule that they are deciding whether to based further emphasizes that the for graphic warnings on cigarette required reference to a cessation purchase or consume a cigarette (75 FR packages and advertisements is 69524 at 69529). Indeed, ‘‘[p]ack-a-day resource is factual in nature. consistent with the First Amendment. We disagree that a reference to a smokers are potentially exposed to Contrary to the comment, the reference warnings more than 7,000 times per cessation resource does not convey to a cessation resource, when information about the product being year’’ (Id.; Refs. 11, 99, and 100). considered in context with the rest of To the extent that the comments sold. The reference must be considered the required warnings, conveys factual discussed other suggested alternatives in context with the rest of the required information to consumers and is (e.g., increased enforcement of sales to warnings, which consist of textual permissible under the Zauderer minors, increased funding for tobacco statements and accompanying graphic standard for compelled disclosures control programs, increased taxes) in the images conveying to consumers factual because it is reasonably related to our context of their ability to reduce youth information regarding the negative interest in increasing the likelihood that smoking, the suggestions provided are health consequences of smoking and the existing smokers will become aware of misplaced in an analysis of benefits of quitting. The reference to a the cessation resource and, requirements whose primary purpose is smoking cessation resource naturally consequently, increasing the likelihood effective communication of health risks. complements this information; instead that those who want to quit will be These suggested alternatives were not of leaving consumers who are motivated successful. It is also reasonably related aimed at communicating health risks to quit by the health risk information to our interest in effectively and were not effective at doing so. In unassisted, it provides them with a communicating the health risks of any event, all of these alternatives have concrete step to take action on this smoking to consumers. been implemented by the government in information. As discussed in detail in section V.B.6 Because the reference to a smoking one form or another and have been of this document, the rule requires each cessation resource conveys factual insufficient. This is reflected in the required warning to include a reference information, it is permissible under findings of the Commonwealth Brands to the existing National Network of Zauderer if it is reasonably related to court: Tobacco Cessation Quitlines (Network), the government’s asserted interest. Here, Plaintiffs’ argument is premised on the which uses the telephone portal 1–800– the reference is reasonably related to idea that ‘‘[b]efore a government may resort QUIT–NOW. This rule will require that FDA’s interest in increasing the to suppressing speech to address a policy the cessation resource be displayed on likelihood that existing smokers will problem, it must show that regulating conduct has not done the trick or that as a the required warning images: ‘‘1–800– become aware of the cessation resource matter of common sense it could not do the QUIT–NOW’’. and, consequently, increasing the trick.’’ (Plaintiffs’ Brief, p. 26) (quoting The NPRM cited evidence that more likelihood that they will successfully BellSouth, 542 F.3d at 508); see also Western than 70 percent of smokers in the quit smoking. As set forth in the States, 535 U.S. at 373. However, that is United States report that they want to discussion of the comments in section precisely what Congress has done here. quit, and approximately 44 percent V.B.6 of this document, foreign Contrary to Plaintiffs’ contention, this is not report that they try to quit each year (75 countries that have included cessation a case where Congress went ‘‘straight to FR 69524 at 69529; Ref. 66 at p. 15). resources on cigarette package warnings [their] speech.’’ (Plaintiffs’ Brief, p. 19). This is a case where Congress, after decades of However, as a result of nicotine have generally experienced large implementing various measures that did not addiction, only a very small percentage increases in volume of calls to quitlines affect Plaintiffs’ speech, decided to add label of these smokers achieve success (75 FR following their appearance on cigarette and advertising restrictions to its 69524 at 69528 through 69529). packages. In addition, as also discussed

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in section V.B.6 of this document, the as well as a regulatory taking of their companies have failed to identify the effectiveness of telephone quitlines is property interests in their trademarks. sort of property right the destruction of well documented; there is evidence that (Response) We disagree that the rule which would result in a per se taking. significant numbers of smokers are effects a taking under either theory. The Furthermore, as the Supreme Court unaware of such assistance, even after Takings Clause provides that ‘‘private has explained, the Takings Clause exists extensive media campaigns; and there is property [shall not] be taken for public ‘‘to bar Government from forcing some evidence that knowing about the use, without just compensation.’’ A people alone to bear public burdens availability of a quitline increases quit takings analysis begins with a threshold which, in all fairness and justice, should attempts and successful cessation even determination of what interest a person be borne by the public as a whole’’ among smokers who do not call the has in the thing that is allegedly taken (Armstrong v. United States, 364 U.S. quitline. (see Ruckelshaus v. Monsanto Co., 467 40, 49 (1960); see Monongahela Nav. Co. Moreover, requiring a smoking U.S. 986, 1001 (1984)). In order to assert v. United States, 148 U.S. 312, 325 cessation resource is also reasonably a taking, a person must first identify a (1893)). The tobacco companies’ related to FDA’s interest in effectively specific, concrete property interest that argument amounts to an assertion that communicating the health risks of has been invaded or destroyed by the they must be compensated because they smoking to consumers. As noted in the government (Penn Central Transp. Co. have been required to allow health NPRM (75 FR 69524 at 69541) and in v. New York City, 438 U.S. 104, 124–25 warnings on their property. The point of section V.B.6 of this final rule, there is (1978)). Once a concrete property the warnings is to protect the public evidence to show that including a interest is identified, it is necessary to health by informing consumers about reference to a smoking cessation determine whether the government’s the many harmful effects of the resource in graphic warnings can action constitutes a taking of that companies’ products, which kill an enhance the effectiveness of graphic interest. estimated 443,000 Americans every warnings at conveying health risk The graphic warning requirements do year. Therefore, the proposition that the information to the public. We have not effect a per se taking. To conclude public must pay for the cost of the determined that it is also important to that a categorical, or per se, taking has warnings on tobacco products is simply inform smokers about a specific tool occurred when the government directly not compatible with how ‘‘the burden of they can use to help them to quit appropriates or physically invades common citizenship’’ is proportioned in smoking at the time they are looking at property is another way of saying that our system of modern government (see the warnings and thinking about the the government action so onerously Keystone Bituminous Coal Ass’n v. health consequences of smoking and the burdens an important property right that DeBenedictis, 480 U.S. 470, 488–91 positive health benefits of quitting. Risk the inquiry ends there. As the Supreme (1987); Pennsylvania Coal Co. v. Mahon, communication research indicates that Court has explained: ‘‘A permanent 260 U.S. 393, 413 (1922) (‘‘Government messages that arouse fear about the physical invasion, however minimal the hardly could go on if to some extent health risks of smoking should be economic cost it entails, eviscerates the values incident to property could not be combined with information on concrete owner’s right to exclude others from diminished without paying for every steps that can be taken to reduce those entering and using her property— such change in the general law.’’)). risks (Ref. 81 (Messages that arouse fear perhaps the most fundamental of all In addition, the graphic warning ‘‘appear to be effective when they depict property interests’’ (Lingle v. Chevron requirements do not effect a regulatory a significant and relevant threat * * * U.S.A. Inc., 544 U.S. 528, 539 (2005); taking. The tobacco companies also and when they outline effective see also Loretto v. Teleprompter argue that the warnings constitute a responses that appear easy to Manhattan CATV Corp., 458 U.S. 419, regulatory taking because they have a accomplish * * *.’’)). As one comment 433 (1982) (citation omitted) (‘‘[T]he reasonable expectation that their stated, providing information about how land-owner’s right to exclude [is] ‘one of property rights will be protected based to reduce a risk that arouses fear helps the most essential sticks in the bundle on statutory and common law to prevent consumers from suppressing of rights that are commonly protections provided to trademarks and thoughts about such risks, and thereby, characterized as property.’ ’’)). trade dress. The tobacco companies do failing to process the risk information. Viewed in this light, a requirement not identify the specific statutory or For this reason, too, we do not agree that that tobacco companies display graphic common law protections that led to the requirement to refer to a smoking health warnings as part of the package their expectation that their property cessation resource on cigarette packages label on their products cannot be would be protected. Also lacking is an and advertisements violates the First equivalent to the ‘‘physical invasion’’ of explanation of how the rule would Amendment. real property in the cases that the interfere with such expectations. In any comment cites to support its per se C. Takings Under the Fifth Amendment event, we do not agree that the rule takings argument (see Loretto, 458 U.S. effects a regulatory taking of the tobacco We received a comment related to the at 441 (‘‘Our holding today is very Takings Clause of the Fifth Amendment. companies’ property. narrow.’’)). The warnings involve The Supreme Court has declined to That comment is summarized and personal property of a type that is responded to in the following prescribe a ‘‘set formula’’ for identifying already subject to extensive government takings and instead has characterized a paragraphs. regulation. Indeed, given the ubiquitous (Comment 201) One comment takings analysis as an ‘‘essentially ad nature of government-mandated hoc, factual’’ inquiry (Penn Central, 438 submitted by several tobacco companies warnings on all kinds of consumer argued that the new health warning U.S. at 124). Nonetheless, the Court has products, manufacturers of inherently identified three factors for consideration requirements unconstitutionally deprive dangerous products such as cigarettes them of their property rights in violation in assessing whether a regulatory taking cannot be said to have a categorical right has occurred: (1) The character of the of the Takings Clause of the Fifth to exclude health warnings from their Amendment. The tobacco companies 9 products’ labels. Therefore, the tobacco variety of cold symptoms, the required warnings asserted that the new required warnings together with other FDA-required information constitute a per se physical taking of 9 For example, for products such as pain relievers, typically encompass more than 50 percent of the their packaging and advertising space, certain allergy medications, and products to treat a product packaging (see 21 CFR 201.66).

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governmental action; (2) the regulation’s second factor of the analysis also VIII. Implementation Date economic impact; and (3) the extent to supports the conclusion that no taking In the preamble to the proposed rule, which the regulation interferes with will occur as a result of the rule. FDA stated that the final rule would The vague suggestion that the rule reasonable investment-backed become effective 15 months after the interferes with tobacco companies’ expectations (Ruckelshaus, 467 U.S. at date the final rule publishes in the ‘‘reasonable investment-backed 1005). The force of any one of these Federal Register. This time period is expectations’’ is similarly unpersuasive. factors may be ‘‘so overwhelming * * * consistent with section 201(b) of the To be reasonable, expectations must that it disposes of the taking question’’ Tobacco Control Act, which specifies take into account the power of the State (Id.). that the requirements for health With respect to the first Penn Central to regulate in the public interest (Pace warnings on cigarette packages and in factor, the character of the government Resources, Inc. v. Shrewsbury advertisements are effective 15 months action, the government is ‘‘given the Township, 808 F.2d 1023, 1033 (3d after the issuance of the regulations that greatest leeway to act without the need Cir.), cert. denied, 482 U.S. 906 (1987)). to compensate those affected by their The nature of the property, and whether FDA issues in this rulemaking. In particular, we proposed that as of actions’’ when the government has acted it has historically been, or potentially the effective date, no manufacturer, for ‘‘the protection of health and safety’’ could be, subject to regulation also aids importer, distributor, or retailer of (Rose Acre Farms, Inc. v. United States, in determining whether any expectation 559 F.3d 1260, 1281 (Fed. Cir. 2009)). in remaining free from regulation is cigarettes may advertise or cause to be Indeed, the Supreme Court has rejected reasonable. ‘‘[I]n the case of personal advertised within the United States any takings claims arising out of health and property, by reason of the State’s cigarette product unless the advertising safety legislation even where a property traditionally high degree of control over complies with the final rule. With interest has been destroyed (see Penn commercial dealings, [the property respect to cigarette packages, we Central, 438 U.S. at 125–27 (citing owner] ought to be aware of the explained that cigarettes must not be cases)). Thus, as explained previously, possibility that new regulation might manufactured after the effective date this factor of the analysis weighs even render his property economically unless their packages comply with the strongly in favor of finding that no worthless * * *.’’ (Lucas v. South regulation. If any packaged cigarette taking will occur as a result of this rule. Carolina Coastal Council, 505 U.S. product was manufactured prior to the The second factor to consider is the 1003, 1027–28 (1992)). This is effective date and does not comply with economic impact of the government particularly true with respect to the final rule, a manufacturer may action. The analysis involves looking cigarettes, which are lethal and continue to introduce that package into not just at what has been lost, but at the addictive—features the industry masked commerce in the United States for an nature and extent of the interference for decades while stimulating underage additional 30 days after the effective with rights in the property as a whole demand (see United States v. Philip date of the final rule. After 30 days (see Penn Central, 438 U.S. at 130–31). Morris USA, Inc., 566 F.3d 1095, 1124 following the effective date, a Thus, it is necessary to assess the (DC Cir. 2009); United States v. Philip manufacturer may not introduce into impact of the rule on tobacco Morris USA, Inc., 449 F. Supp. 2d 1, 580 domestic commerce any cigarette the companies’ trademarks, packages, and (Finding 2717) (D.D.C. 2006); Ref. 54 at package of which does not meet the advertisements as a whole. In assessing p. 211). Commerce in tobacco products requirements of the final rule (75 FR whether a regulation effects a taking, the has been regulated for decades, subject 69524 at 69541). We noted that this Supreme Court has considered whether to increasingly more restrictive Federal, limitation applied only to the regulation denies an owner the State, and local measures over time. manufacturers and requested comments ‘‘economically viable’’ use of its Indeed, Congress has mandated regarding mechanisms for enforcing this property. Mere denial of the most warnings on cigarette packs since 1965 rule and its effective date, including profitable or beneficial use of property (see Federal Cigarette Labeling and ways to differentiate cigarette packages does not require a finding that a taking Advertising Act of 1965 (FCLAA), Pub. sold from inventory manufactured prior has occurred (see, e.g., Keystone, 480 L. 89–92, 79 Stat. 282). Congress later to the effective date rather than from U.S. at 498–99). Here, tobacco amended FCLAA to update the text of inventory manufactured after the companies have not shown how the rule the cigarette warnings and mandate effective date. deprives them of the use of their them in cigarette advertisements as well We received several comments about intellectual property or packaging to (see Comprehensive Smoking Education the effective date, particularly such a severe extent to effect a taking Act of 1984, Pub. L. 98–474, 98 Stat. requesting clarification regarding its (see Village of Euclid v. Ambler Realty 2200). In light of this long history of application to manufacturers, Co., 272 U.S. 365, 384 (1926) (75 regulation, companies that package and distributors, and retailers after the 30- percent diminution in value insufficient advertise cigarettes lack a reasonable day period in which manufacturers may to prove taking); Hadacheck v. investment-backed expectation that they continue to sell noncompliant packages. Sebastian, 239 U.S. 394, 405 (1915) will be able to continue to use their Based on the comments and our review (92.5 percent diminution insufficient to property without modification of the of the language in section 201(b) of the prove taking)). Manufacturers, regulatory requirements that protect the Tobacco Control Act, we find: importers, distributors, and retailers public health. Any expectation that the • The effective date should be 15 will still be able to use packages and industry would escape comprehensive months after the date of publication in advertisements to sell cigarettes. Indeed, regulation, such as the Tobacco Control the Federal Register of this final rule; manufacturers still have use of 50 Act, was eminently unreasonable. • No manufacturer, importer, percent of the front and rear panels of For these reasons, the third factor of distributor, or retailer may advertise any cigarette packages, as well as the side the takings analysis, like the first two cigarette product after the effective date panels and the top and bottom panels, factors, compels the conclusion that the if the advertisement does not comply to use their trademarks and otherwise rule does not amount to a regulatory with this rule; promote their products. Eighty percent taking of property that requires • After the effective date, no person of the area of each advertisement will compensation under the Fifth may manufacture for sale or distribution likewise be available. Accordingly, the Amendment. within the United States any cigarette

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the package of which does not comply (Response) As in the proposed rule, means out of the manufacturer’s with this rule; the implementation date in the final possession. The comment raised this • Beginning 30 days after the effective rule is the same for all manufacturers, question in the context of expressing date of this rule, a manufacturer may regardless of size. concern that distributors and retailers not introduce into domestic commerce (Comment 204) One comment might want to return product to a any cigarette, irrespective of the date of requested that FDA delay manufacturer if there is doubt about a manufacture, if its package does not implementation of the rule until distributor or retailer being permitted to comply with the requirements of this Constitutional issues raised in the sell cigarette packages that do not have rule; comment are resolved either a required warning, but were introduced • After the effective date, an importer, administratively or through litigation. intro domestic commerce by the distributor, or retailer may not sell, offer (Response) We disagree that the manufacturer during the 30-day sell to sell, distribute, or import for sale or effective date of this rule should be through period for manufacturers. distribution within the United States delayed beyond the 15 months proposed (Response) We agree with this any cigarette the package of which does in the NPRM. As explained in section comment that when a cigarette package not comply with this regulation, unless VII of this document, we disagree that has been sold by the manufacturer and the cigarette was manufactured prior to there are any Constitutional deficiencies is in the possession of a distributor or the effective date; and associated with this rule and, therefore, retailer, the product would be • After the effective date, however, a there is no need to revise the rule or considered introduced into domestic retailer may sell cigarettes the packages issue a new proposed rule to address commerce. However, we do not agree of which do not have a required these alleged deficiencies. Furthermore, that a definition of ‘‘introduce into warning if the retailer demonstrates it section 201(b) of the Tobacco Control domestic commerce’’ is needed at this falls outside the scope of this rule as Act specifies that the requirements for time. The comment recognized that described in § 1141.1(c). health warnings on cigarette packages there was similar language in the and in advertisements for cigarettes are In the following paragraphs, we describe context of a statutory prohibition on the effective 15 months after the issuance of the individual comments concerning the use of ‘‘light,’’ ‘‘low,’’ and ‘‘mild’’ effective date and respond to these this final rule. (Comment 205) Several comments descriptors and related FDA guidance comments. for industry, however, that guidance did (Comment 202) Several comments addressed the 30-day period for not define the phrase ‘‘introduce into expressed the view that 15 months is an manufacturers to sell noncompliant domestic commerce.’’ We are not aware excessive amount of time to allow the packages that were manufactured prior of confusion regarding this phrase in the tobacco industry before it must comply to the effective date. One comment with the new requirements of this asserted that it is unnecessary to permit context of ‘‘light,’’ ‘‘low,’’ and ‘‘mild’’ rulemaking. For example, some this 30-day sell-off period if there is descriptors and decline to define that comments contended that tobacco adequate time for manufacturers to phrase here. companies have employed marketing make necessary changes to cigarette (Comment 207) Public health and advertising experts and are packages prior to the effective date. The advocacy groups expressed concern that continuously changing cigarette comment cited the United Kingdom as manufacturers will seek to sell a packaging and advertisements. These an example of a jurisdiction where disproportionate number of comments also noted that the tobacco tobacco product manufacturers had noncompliant cigarette packages industry has known that they will need adequate lead time (1 year to implement immediately prior to the expiration of to update packaging and advertising to changes to cigarette packages and 2 the 30-day sell-off period and, therefore, comply with this regulation since the years to introduce picture warnings on FDA should take steps to ensure that all passage of the Tobacco Control Act. other tobacco products) to meet these sales are fully documented. The Some comments estimated the number implementation deadlines so that only comment recommended that FDA of Americans that will become new compliant packages were sold after the impose certain requirements for selling smokers or die due to smoking during compliance deadline. Other comments noncompliant cigarette packages, such the 15 months prior to the effective date. recognized that the statute grants as a requirement to mark these packages Other comments recognized that the manufacturers 30 days to sell with a statement that the product was statute specifies a 15-month effective noncompliant cigarette packages; manufactured prior to September 22, date, but requested that FDA make clear however, these comments emphasized 2012, or with a readily identifiable that cigarette packages manufactured that FDA does not have the discretion symbol. This comment also after the effective date must comply to lengthen the 30-day period. recommended that each manufacturer with the requirements of the regulation. Comments also stressed that any be required to certify that all cigarettes (Response) The Tobacco Control Act additional delay of implementation so marked were manufactured before specifies a 15-month implementation would needlessly delay the important that date and submit an accounting of period for cigarette manufacturers to public health benefits of the rule. the number of packages on hand as of include required warnings on their (Response) As explained previously, the effective date, the number of packages and for all cigarette section 201(b) of the Tobacco Control cigarette packages introduced into advertisements to comply with this rule. Act specifies that manufacturers have an commerce during the 30-day period, We agree this is an appropriate amount additional 30 days to sell cigarette and the number of packages on hand as of time for implementation of the rule. packages that do not meet the of the expiration of the 30-day period. (Comment 203) One tobacco product requirements of the regulation if those This comment also suggested that FDA manufacturer indicated in its comment packages were manufactured prior to not permit manufacturers to introduce that all manufacturers should be the effective date. into commerce in any calendar month a required to implement the same (Comment 206) A small tobacco number of noncomplying cigarette warning requirements within the same product manufacturer requested that packages that exceeds 10 percent of the time periods, and that there should not FDA specify the meaning of the term average total number of cigarette be a separate implementation period for ‘‘introduce into domestic commerce.’’ packages introduced per month during small manufacturers. The comment asked whether the term the preceding year.

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(Response) We disagree that such of FCLAA and any warning plan any cigarette the package of which does specific requirements are necessary to approved by the FTC. not comply with this regulation, unless address a one-time sell-off period of 30 (Comment 210) Many comments the cigarette was manufactured prior to days. We recognize that some requested clarification regarding the effective date. After the effective manufacturers may try to increase their whether there is any limitation on the date, however, retailers may sell sales of cigarette packages prior to the period during which distributors and cigarettes the packages of which do not effective date and prior to the expiration retailers may sell cigarettes that were have a required warning if they of the sell-off period. However, there manufactured prior to the effective date demonstrate they meet the provisions of will be some limit to the demand for that are not compliant with the rule. § 1141.1(c) and are exempt from the these cigarette packages. Manufacturers Several comments submitted by requirements of 21 CFR part 1141 that may increase manufacturing prior to the organizations representing apply to the display of health warnings effective date at their own risk. After the manufacturers and retailers asked that on cigarette packages. 30-day sell-off period, a manufacturer FDA clarify that distributors and IX. Federalism may not sell noncompliant cigarette retailers have an unlimited period to packages and would need to repackage sell cigarette packages that do not FDA has analyzed this final rule in or destroy any noncompliant cigarettes comply with the regulation as long as accordance with the principles set forth packages intended to be sold in the the cigarettes were manufactured prior in Executive Order 13132. Section 4(a) United States. to the effective date. Several comments of the Executive order requires agencies (Comment 208) One comment noted that this approach would be to ‘‘construe * * * a Federal statute to requested that importers be required to consistent with FDA’s treatment of preempt State law only where the comply with all requirements applicable cigarettes with the descriptors ‘‘light,’’ statute contains an express preemption to manufacturers. According to this ‘‘low,’’ and ‘‘mild.’’ One manufacturer provision or there is some other clear comment, importers should be commented that any restraint on the evidence that the Congress intended prohibited from introducing ability of distributors or retailers to sell preemption of State law, or where the noncomplying cigarettes imported after through their lawfully acquired product exercise of State authority conflicts with the effective date and should be would unfairly deprive them of the the exercise of Federal authority under required to meet the same requirements benefit of their investment. Small the Federal statute.’’ This rule is being as manufacturers with respect to tobacco product manufacturers noted issued under section 4 of FCLAA, as cigarettes manufactured prior to the that small manufacturers cannot afford amended by the Tobacco Control Act, effective date and sold after the effective to have distributors and retailers and sections 701(a), 903, and 906 of the date. returning product based on a potential FD&C Act (21 U.S.C. 371(a), 387c, and (Response) This comment did not labeling concern. Retailer comments 387f), as amended by the Tobacco provide a statutory interpretation that contended that limiting a sell-off period Control Act. Federal law includes an would justify this approach. Section may cause a severe financial burden on express preemption provision that 201(b) of the Tobacco Control Act states small retailers because manufacturers preempts any requirement, except under the effective date ‘‘shall be with respect generally do not allow cigarettes to be the Tobacco Control Act, for a to the date of manufacture’’ and that 30 returned. Retailers also claimed that ‘‘statement relating to smoking and days after the effective date, a cigarettes do not have an indefinite shelf health, other than the statement manufacturer is precluded from life and both distributors and retailers required by section 4 of [FCLAA], * * * introducing into domestic commerce generally turn over their cigarette on any cigarette package.’’ (section 5(a) any product that is not in conformance inventory in a timely manner. One of FCLAA (15 U.S.C. 1334(a))). It also with section 4 of FCLAA. No similar comment suggested that retailers should includes an express preemption statutory provision applies to importers be allowed to sell noncompliant provision that preempts any or distributors. cigarette packages at least through their ‘‘requirement or prohibition based on (Comment 209) Public health ‘‘sell by’’ date, as indicated on the smoking and health * * * imposed advocacy groups requested that FDA cigarette package by the manufacturer. under State law with respect to the clarify that manufacturers are not On the other hand, one comment advertising or promotion of any prohibited from introducing into claimed it is essential that there be a cigarettes the packages of which are commerce cigarette packages that fixed implementation deadline at the labeled in conformity with the comply with the regulation prior to the retail level or old stock can be expected provisions of [FCLAA],’’ which includes effective date. to remain on retail store shelves for 6 section 4 of FCLAA (section 5(b) of (Response) We agree that months and more after the effective FCLAA). However, section 5(b) of manufacturers are not precluded from date. FCLAA does not preempt any State or introducing into commerce cigarette (Response) As explained in the local statutes and regulations ‘‘based on packages that contain required warnings NPRM, section 201(b) of the Tobacco smoking and health, that take effect after in accordance with the regulation prior Control Act describes no limitation on [June 22, 2009], imposing specific bans to the effective date. We also note that the period during which distributors or restrictions on the time, place, and a cigarette manufacturer, importer, or and retailers may sell cigarette packages manner, but not content, of the retailer may include a required warning that were manufactured prior to the advertising or promotion of any in an advertisement prior to the effective date of this rule. In addition, cigarettes’’ (section 5(c) of FCLAA). effective date. However, because the there is no requirement that In addition, section 916(a)(2) of the health warning requirements in FCLAA manufacturers include a ‘‘sell by’’ date FD&C Act (21 U.S.C. 387p) expressly do not change until the effective date of on all cigarette packages. We note, preempts any State or local requirement this rule, any manufacturer, importer, or however, that distributors, importers, ‘‘which is different from, or in addition retailer that, prior to the effective date, and retailers are responsible for to, any requirement under [Chapter IX includes a new required warning on a complying with this rule. After the of the FD&C Act] relating to,’’ among cigarette package or advertisement must rule’s effective date, they may not sell, other things, misbranding and labeling. also comply with the warning offer to sell, distribute, or import for sale This express preemption provision, requirements under the current version or distribution within the United States however, ‘‘does not apply to

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requirements relating to’’ among other 40 CFR 1508.4). However, FDA will and safety, and other advantages; things ‘‘the sale, distribution, * * * require at least an EA for any specific distributive impacts; and equity). This access to, [or] the advertising and action that ordinarily would be rule is an economically significant promotion of * * * tobacco products.’’ excluded if extraordinary circumstances regulatory action under Executive Order indicate that ‘‘the specific proposed 12866. X. Environmental Impact action may significantly affect the The Regulatory Flexibility Act FDA has determined under § 25.30(k) quality of the human environment’’ (see requires agencies to analyze regulatory (21 CFR 25.30(k)) that this action is of 21 CFR 25.21; 40 CFR 1508.4). options that would minimize any a type that does not individually or A regulation to modify labeling significant impact of a rule on small cumulatively have an impact on the regulations constitutes a major Federal entities. This rule will have a significant human environment. Therefore, neither action under NEPA (see 40 CFR economic impact on a substantial an environmental assessment (EA) nor 1508.18), and typically requires at least number of small entities. an environmental impact statement an EA under 21 CFR 25.20(f). However, Section 202(a) of the Unfunded (EIS) is required. We received one regulations establishing labeling Mandates Reform Act of 1995 requires comment on this issue, which we have requirements for marketed articles are that agencies prepare a written summarized and responded to in the categorically excluded, if the action will statement, which includes an following paragraphs. not result in (1) increases in the existing assessment of anticipated costs and (Comment 211) One comment levels of use of the article or (2) changes benefits, before proposing ‘‘any rule that expressed concern regarding FDA’s in the intended use of the article includes any Federal mandate that may statement in the proposed rule that this (§ 25.30(k)). Therefore, FDA would not result in the expenditure by State, local, action does not individually or be required to file an EA if it meets and Tribal governments, in the cumulatively have an impact on the these requirements. aggregate, or by the private sector, of human environment. The comment We have determined that this $100,000,000 or more (adjusted stated that there is an impact on the regulation meets the requirements for a annually for inflation) in any one year.’’ environment due to the fact that a categorical exclusion. First, this The current threshold after adjustment reduction in the number of cigarettes regulation is clearly not expected to for inflation is $136 million, using the consumed will result in a reduction of increase cigarette usage. In fact, this most current (2010) Implicit Price cigarette-related waste. The comment regulation is expected to cause a Deflator for the Gross Domestic Product. explained that cigarette butts pose a reduction in overall smoking rates and This rule will result in a 1-year greater health hazard than most other initiation, and we estimate that this rule expenditure that meets or exceeds this litter, because they contain toxins that will reduce the number of smokers by amount. can be leached into water systems. The 213,000 in 2013, with smaller additional Conducting an impact analysis under comment requested that this be reductions through 2031. Second, the Executive Order 12866, Executive Order included in FDA’s analysis to rule will not affect the way in which 13563, the Regulatory Flexibility Act, understand the large positive impact the and the Unfunded Mandates Reform Act cigarettes are used among smokers and required warnings will have on the involves assembling any available it does not change the intended use of human environment. information that is relevant to the (Response) We have considered this cigarettes. In addition, we have determined that assessment of a regulation’s benefits and comment, but have concluded that there is no potential for serious harm to costs. It is not uncommon in scientific neither an EA nor an EIS is required pursuits for there to be a lack of the environment resulting from the final under § 25.30(k). We have determined definitive information on some aspects rule that would otherwise constitute an that a categorical exclusion applies in of the question under investigation, and extraordinary circumstance (see 21 CFR this instance, because (1) the action the impact analysis of this final rule is 25.21). Our action to regulate cigarette meets the criteria of the exclusion, i.e., no exception. In light of this situation, labeling does not lead to an increase in there are no increases in existing levels we identify and present a range of the level of use of these articles or a of use or changes in intended use, and possible benefits and costs. (2) there are no extraordinary change in the intended use of these The benefits, costs, and distributional circumstances. articles or their substitutes. The primary effects of the final rule are summarized According to the National effect of this regulation will be to reduce in table 1a of this document. As the Environmental Policy Act of 1969 smoking initiation and increase table shows, the midpoint of the (NEPA) and the Agency’s corresponding cessation efforts. Accordingly, there is estimates for benefits annualized over regulations, FDA must prepare an EIS no extraordinary circumstance that 20 years is approximately $630.5 for major Federal actions ‘‘significantly requires the filing of an EA. million at a 3-percent discount rate and affecting the quality of the human XI. Analysis of Impacts $221.5 million at a 7-percent discount environment’’ (see 40 CFR 1501.4; 21 rate. The midpoint for costs annualized CFR 25.22). If the action ‘‘may’’ have A. Introduction and Summary over 20 years is approximately $29.1 such a significant environmental effect, FDA has examined the impacts of the million at a 3-percent discount and $37 an agency must prepare an EA to final rule under Executive Order 12866, million at a 7-percent discount rate. provide sufficient evidence and analysis Executive Order 13563, the Regulatory The total benefits and costs of the for the agency to determine whether to Flexibility Act (5 U.S.C. 601–612) and final rule can also be expressed as prepare an EIS or a finding of no the Unfunded Mandates Reform Act of present values. The midpoint of the significant impact (FONSI) (see 40 CFR 1995 (Pub. L. 104–4). Executive Orders estimates for the present value of 1501.3; 21 CFR 25.20). Agencies can 12866 and 13563 direct agencies to benefits over 20 years is approximately establish categorical exclusions for assess all costs and benefits of available $9.4 billion at a 3-percent discount rate categories of actions that do not regulatory alternatives and, when and $2.3 billion at a 7-percent discount individually or cumulatively have a regulation is necessary, to select rate. The midpoint of the estimates for significant effect on the human regulatory approaches that maximize the present value of costs over 20 years environment and for which, therefore, net benefits (including potential is approximately $434 million at a 3- neither an EA nor an EIS is required (see economic, environmental, public health percent discount rate and $392 million

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at a 7-percent discount rate. With both Order 13563, section 1(b), requires that, justify its costs.’’ The regulation is discount rates, our midpoint estimates to the extent permitted by law, agencies consistent with this requirement. indicate that the benefits of the rule proceed with a regulation ‘‘only upon a BILLING CODE 4160–01–P greatly exceed the costs. Executive reasoned determination that its benefits

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BILLING CODE 4160–01–P As shown in table 1b of this document, saved, annualized at a 3-percent Our primary estimate of annualized these net benefits are associated with discount rate, or 19,687 smoking net benefits equals $601.4 million, with 16,544 smoking preventions and 5,802 preventions and 1,749 QALYs saved, a 3-percent discount rate, or $184.5 quality-adjusted life-years (QALYs) annualized at a 7-percent discount rate. million, with a 7-percent discount rate.

FDA’s estimate of the benefits of the to isolate the effect of graphic warnings certain financial outlays, such as life rule is determined by the predicted on smoking rates from the effects of insurance premiums that are not reduction in the number of U.S. smokers other interventions to reduce smoking actuarially fair,10 that implicitly and the consequent reduction in the in Canada and the United States. This subsidize smoking. Individuals who are number of people who will ultimately comparison yields an estimate of how dissuaded from smoking by the rule become ill or die from diseases caused the graphic warnings required by this receive benefits equal to the value of by smoking. In the first step of our rule will reduce smoking rates in the cessation or avoided initiation. We use analysis, we conclude that graphic United States. FDA estimates that this two methods of estimating this value, warnings on cigarette packages will rule will reduce the number of smokers one that extrapolates from the price of reduce smoking rates (both by by 213,000 in 2013, with smaller actual cessation programs and one that encouraging smokers to quit and by additional reductions through 2031. measures the excess value of health deterring nonsmokers from starting). This estimated drop in the smoking improvements, over and above what This conclusion is based on an analysis rate in turn allows us to estimate smokers give up by not engaging in the of the experience of Canada, which benefits that will accrue to dissuaded activity of smoking. Our estimates of introduced graphic warnings on smokers and to other members of health improvements include the cigarette packages in December 2000. By society. Some individuals whose monetized value of life extensions, the comparing smoking rates in the United smoking status is not affected by the monetized benefits from improved States with those in Canada and required graphic warning labels will accounting for other relevant differences receive benefits from the rule-induced 10 The term ‘‘actuarially fair’’ refers to insurance between the two countries, we are able reductions in smoking-related fires and premiums that are exactly equal to expected losses.

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health status (avoided nonfatal health multiple estimation methods. Table 2 of mothers smoking during pregnancy. consequences or morbidity from this document shows the benefits These benefits are likely to be smoking), and reductions in medical broken down into the value of gained significant, but FDA has been unable to costs. We do not have direct estimates life-years, improved health status, obtain reliable data with which to for the value smokers attach to the medical cost reductions, other financial quantify them with greater precision activity of smoking, which adds some effects, and reduced fire-related losses. than an order-of-magnitude uncertainty to the second benefits Most of the public health benefits from approximation which will be discussed estimation method. We therefore the rule will be realized in the future, in the ‘‘Benefits’’ section of this present several benefits estimates for perhaps several decades after the rule Analysis of Impacts. In particular, we which there is some justification in the takes effect. were not able to project future levels of literature or in comments on the The estimated totals may understate exposure to secondhand smoke (passive proposed rule. For each discount rate the full public health benefits of the rule smoking) from historical trends. We and value of a statistical life-year because they fail to quantify reductions (VSLY), our primary benefits result is in external effects attributable to passive were also unable to quantify reductions the midpoint between the lower and smoking and the reduction in infant and in the cost of excess cleaning and upper bound values generated by the child morbidity and mortality caused by maintenance costs caused by smoking.

The total estimated costs of administrative and recordkeeping costs experience costs for short-term implementing cigarette graphic warning to manufacturers of ensuring equal and dislocations of current business labels include $319.5 million to $518.4 random display of the nine different activities, but the costs will be mitigated million in one-time costs and $6.6 to warning labels over time, the costs to for those businesses that anticipate the $7.1 million in annual recurring costs. large manufacturers of market-testing industry’s adjustments to the final rule. Annualized over 20 years, the total costs new cigarette package labels, and the In addition to the costs described range from $27.4 million to $40.8 costs to manufacturers and retailers of previously, the rule will lead to private million with a 3-percent discount rate removing point-of-sale advertising that costs in the form of reduced revenues and from $34.7 million to $52.7 million does not comply with the rule. There for many firms in the affected sectors. with a 7-percent discount rate, as shown are also costs to the Government of These sector-specific revenue in table 3 of this document. These totals administering and enforcing the rule. reductions are for the most part include the costs to manufacturers of FDA could not quantify every regulatory distributional effects and cannot be changing cigarette labels, the cost. Some commercial sectors will counted as social costs.

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As tobacco industry revenues decline, 2. Need for the Rule the United States, United Kingdom, or State and Federal tobacco tax revenues In the preliminary impact analysis of Australia—countries that required only will also fall. If excise tax rates on the graphic warning label rule, FDA text warnings at the time of the survey— tobacco products remain at current cited our statutory mandate as the to know that smoking causes heart levels, annual State tax revenues will primary need for the regulation. We disease, stroke, and impotence and that fall by approximately $25.1 million and received a comment stating that we had cigarettes contain such chemicals as annual Federal tax revenues by $19.3 failed to discuss the economic rationale carbon monoxide and cyanide. The U.S. Census indicates that nearly million. for the rule. 11 million respondents in the year 2000 In the following section, FDA (Comment 214) One comment stated did not speak English well or very well responds to comments on the economic that FDA, in the preliminary Analysis of (Ref. 102); the non-English-speaking analysis of the proposed rule. The full Impacts, failed to identify the market population has likely increased in the economic analysis of the final rule failure that the regulation is addressing. intervening years. Moreover, the begins in section XI.C of this document. The comment went on to state that Department of Education reports that, in warning labels are a means of B. Comments on the Preliminary 2003, 30 million American adults, aged disseminating information, and if Regulatory Impact Analysis 16 and over, possessed ‘‘below basic’’ consumers are already fully informed prose literacy skills (Ref. 113). Images of 1. General about a particular product, there can be smoking’s consequences and translation In the Preliminary Regulatory Impact no increase in consumer welfare due to of warnings into Spanish and other Analysis (PRIA), FDA estimated various the addition or revision of a warning languages can provide health benefits, costs and transfers brought label. information to consumers who lack (Response) An absence of adequate about by the graphic warning label rule. English literacy. We received comments on the PRIA information is a well-established market FDA also notes that the economics from approximately seven tobacco failure, one which provides a rationale and psychology literatures suggest manufacturers or industry groups, one for disclosure requirements. There is several rationales, other than advertising industry group, four evidence that smokers may not be fully incomplete or imperfect information, for nonprofit organizations, a group of informed of the risks associated with policy intervention in the realm of researchers and an individual researcher cigarette smoking and that large graphic smoking. The growing literature on affiliated with a medical school, two warning labels can be more effective at myopia, self-control, and time- economists submitting on behalf of the providing information than small, text- inconsistency examines situations in tobacco industry, one additional only warnings. There is also evidence which consumers may overvalue economist, and several private citizens. that those who have an accurate (relatively modest) short-term benefits Two comments related to the scope of understanding of the statistical risks and undervalue (relatively large) mid- the effects that should have been may underestimate their personal risks; term or long-term harms. The theoretical estimated in the PRIA and to a and even where consumers have an and empirical evidence suggests the parameter choice that affected several accurate understanding, the risk might possibility that through their decisions portions of the analysis. not be considered at the time of at early stages, smokers may impose purchase (Ref. 183). (Comment 212) One comment stated significant costs on their future selves, Evidence on some of these points is producing net losses in terms of welfare; that FDA’s use of a 7-percent discount provided by O’Hegarty et al. (Ref. 111), rate is not appropriate. if so, these costs might legitimately be who find that young American taken into account for purposes of (Response) The use of both 3-percent consumers are aware of some health policy. Helping to inaugurate the and 7-percent discount rates is standard consequences of smoking, such as the modern literature, Thomas Schelling practice in regulatory impact analysis increased probability of lung cancer, but suggests in a series of papers that and is required by OMB Circular A–4 not of others, such as the increased smoking and similar behaviors (Ref. 103). probability of stroke. Other evidence on characterized by attempts to quit and (Comment 213) One comment stated this question comes from Khwaja et al. relapses can be interpreted as a contest that FDA should measure the scope of (Ref. 112), who find that smokers aged between two selves: One self trying to the following potentially rule-induced 50 to 65, unlike their nonsmoking stop smoking for health reasons and the phenomena: Increases in the purchase counterparts, underestimate their other self wanting to continue to smoke. of illicit cigarettes (counterfeits, personal probability of dying within the These alternating preferences violate the contraband, cheap whites, etc.), next 10 years. Borland and Hill (Ref. 63, assumption of stable preferences and increases in the presence of Borland 1997) find that Australia’s can provide a rationale for policy nondomestic products (duty-free, etc.), requirement of larger warning labels interventions (Refs. 106, 107, and 108). and decreases in the presence of legal increased tobacco consumers’ Discussing another potential rationale domestic products. knowledge that smoking causes cancer, for policy intervention, Gruber and (Response) FDA has performed a heart and circulatory illnesses, and Ko¨szegi (2001) (Ref. 104) state: ‘‘While quantitative analysis of the regulation’s pregnancy-related problems. O’Hegarty the rational addiction model implies effect on domestic cigarette et al. (Ref. 111) report that American that the optimal tax on addictive bads consumption (sections XI.D.1 and focus group members anticipate that should depend only on the externalities Technical Appendix X6) and a Canadian-style large, graphic warning that their use imposes on society, the qualitative analysis of the international labels would be more effective at time inconsistent alternative suggests a effects of the regulation (section XI.H of communicating health information than much higher tax that depends also on this document). FDA agrees that it the labels currently required in the the ‘internalities’ that use imposes on would be useful to include the effect of United States. Evidence from the consumers.’’ With the graphic warning the rule on illicit cigarette trading in the International Tobacco Four-Country label rule, FDA is undertaking a policy regulatory impact analysis. However, Survey (Ref. 26, Hammond 2006) option that, like a tax, can induce lower due to data limitations, FDA has been supports this conclusion, with Canadian cigarette consumption, and we reach a unable to quantify this effect. smokers more likely than smokers from conclusion similar to that of Gruber and

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Ko¨szegi; we find that individuals who smoking rate at any particular moment it would imply that there would be are dissuaded from smoking are made is a function of all past initiation, more than 3 million dissuaded better off (i.e., they receive a net benefit) cessation, birth, death, and migration of American smokers. as a result of government policy smokers and nonsmokers across (Comment 219) One comment stated intervention. (We note that Gruber and national borders. Therefore, our that the required label change would Mullainathan (Ref. 182), using approach includes the effect of the rule have very little impact on smoking rates subjective well-being data, find that one on initiation. because minors, who form the bulk of regulatory tool—excise taxation—has a (Comment 216) One comment stated new smokers, obtain their cigarettes positive effect on the happiness of those that FDA’s preliminary estimate, that from parents rather than from retail with a propensity to smoke, a result only 82,000 individuals would be establishments. consistent with the results we present in dissuaded from smoking between 2014 (Response) Due to lack of data, FDA’s this analysis.) and 2031, was too low. estimates of the amount of smoking Bernheim and Rangel (Ref. 105) find (Response) FDA’s estimate that the cessation or avoided initiation brought that the benefits of smoking (realized by rule-induced reduction in U.S. smoking about by the rule include only adults smokers themselves) are less than the population will occur mostly during the aged 18 and above, or young persons realized health costs, but chemical first year after implementation of who reach age 18 by the year 2031. The reactions in the brain cause the graphic warning labels is a product of number of minors dissuaded from consumer to mistakenly forecast more the simplicity of our empirical model. smoking by the rule may be substantial. benefits when making consumption We agree that a time trend of the effect Whether they obtain cigarettes from choices than he or she actually realizes of the rule is to be preferred over a friends, through theft, or by purchasing from consuming the addictive product. single average effect. However, our them from retail establishments These authors suggest that this attempts to estimate linear or quadratic operating in violation of youth access overestimation occurs through a flawed time trends have produced highly laws, young people will be exposed to hedonic forecasting mechanism in implausible results, especially for new graphic warning labels because the which particular environmental cues projections furthest into the future. We labels are printed directly on cigarette lead a smoker to move into a ‘‘hot’’ state are then left with a best estimate of how packages. in which he or she overestimates the the rule would decrease the U.S. (Comment 220) One comment stated pleasure from smoking. This analysis smoking rate in which the number of that FDA’s preliminary estimate of the suggests that graphic warning labels dissuaded smokers is smaller for any rule-induced smoking rate reduction may be able to serve as counter-cues year from 2014 to 2031 than for 2013. was too high, in that it did not address that prevent movement into the hot state This estimated change is not a decrease potential competitive responses of the and allow the addict to continue to from year to year (e.g., 2013 to 2014), cigarette companies to the proposed exercise self-control. but a net decrease for a given year in the rule. The comment went on to state that, Laux (Ref. 109) identifies other presence of the rule compared with the under the proposed rule, graphic reasons that smokers may not fully same year in the absence of the rule. warning labels would take up a internalize the costs of their addictive (Comment 217) Two comments stated substantial portion of the area in behavior, including teen addiction as an that FDA’s preliminary estimate of packaging and advertising where firms intrapersonal (two selves) externality, smoking rate reduction was too low, in establish brand recognition, thus partially myopic adult behavior, and that it ignored the fact that someone reducing consumers’ ability to peer effects. who is dissuaded from smoking in 1 distinguish premium from discount According to the model developed by year will likely remain a nonsmoker in brands. This would cause premiums for Gul and Pesendorfer (Ref. 110), if future years. branded cigarettes to decrease and price graphic warning labels reduce the (Response) FDA notes that the competition to intensify, which in turn temptation associated with the addictive likelihood that an individual dissuaded would likely lead to an increase in product, they will reduce smoking and from smoking in a particular year will cigarette usage. increase social welfare. likely continue to be a nonsmoker in (Response) FDA believes that, even if subsequent years was accounted for by well-known brands only have half a 3. Benefits our preliminary estimate, which had the package with which to advertise In the preliminary impact analysis, U.S. smoking rate continuing to be themselves, they still have name FDA estimated a variety of welfare- lower than it otherwise would have recognition. We expect that consumers enhancing effects of the graphic warning been in years 2014 through 2031, not will continue to be able to find their label rule; these included reductions in just in 2013. The same characterization preferred brands; as a result, any change smoking-related mortality, morbidity, holds for the estimate in FDA’s Final in prices due to competitive pressures is medical expenditures, and fire damage. Regulatory Impact Analysis. likely to be small. We received many comments on the (Comment 218) One comment stated The cigarette producers’ strategic methods, assumptions, choice of that ‘‘Canada has used graphic warnings responses suggested by the comment sources, and results that were reported for years, and in the last decade their should have occurred in Canada when in the benefits analysis. smokers dropped from 23% to 22% of that country implemented graphic (Comment 215) One comment stated the population.’’ warning labels. Because FDA’s estimate that FDA’s preliminary estimate of the (Response) Canada’s smoking rate has of the effect of graphic warning labels is rule-induced smoking rate reduction decreased by around seven percentage based on the Canadian experience, we was too low, in that it ignored the rule’s points, not one, since the implicitly account for any decrease in effect on initiation, in favor of a implementation of graphic warning the price of cigarettes caused by cessation-only analysis. labels in late 2000. Even if the one competition between premium and (Response) For both the proposed rule percentage point statistic was correct, a discount brands. Our point estimate and the final rule, FDA has analyzed the one percentage point decrease in the indicates that the net effect of graphic national adult smoking rate (i.e., the smoking rate would not be a small warning labels is a decrease in the nation’s smoking population divided by change when applied to the large national smoking rate in spite of this the nation’s total population). The population of the United States; in fact, possible offsetting effect.

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(Comment 221) One comment stated for differences in cigarette prices over initiatives have been active in the that FDA’s preliminary estimate of the time in the United States and Canada. United States in the past decade. For rule-induced smoking rate reduction (Response) For the analysis of the example, the ‘‘Truth’’ Campaign, a was too high, in that it failed to final rule, FDA has incorporated nationwide advertising effort aimed at recognize or control for other regulatory changes in Canadian and United States discouraging youth smoking, launched changes (such as smoking bans) tax rates into its estimates. in the United States in 2000 and affecting cigarette consumption at the This comment suggests elsewhere that continued into the 2000s. State, provincial, or municipal levels. graphic warning labels will cause prices (Comment 226) One comment stated (Response) FDA acknowledges that to decrease. FDA agrees that this is a that FDA’s preliminary estimate of the our model does not explicitly allow for possibility. Thus, for the non-tax rule-induced smoking rate reduction many potential confounding factors, but portion of cigarette prices, we are faced was too high, in that it failed to account we note that our estimates of the effect with what economists call an for the fact that individuals over age 65 of graphic warning labels could as easily endogeneity problem; it is difficult to are less likely to be smokers than be underestimates as overestimates. determine, in an empirical analysis in younger individuals and Canada’s More specifically, our model will which price is used directly as a control population is aging more rapidly than produce an overestimate if: Smoking- variable, the direction and magnitude of that of the United States. Specifically, reducing phenomena (other than causality. However, if the changes in the during the period 2001 through 2009, graphic warning labels) were growing in non-tax portion of prices in the United Canada’s over-65 population grew by 21 prevalence or effectiveness at a faster States and Canada follow the same percent while the U.S. over-65 rate in Canada after 2000 than before pattern post-2000 as they did pre-2001, population grew by only 12 percent. 2001, smoking-reducing phenomena and if the relationship between smoking Canada’s over-65 population (other than graphic warning labels) were status and cigarette prices was also represented 13.9 percent of its total more prevalent or effective in Canada relatively constant between the two time population in 2009, up from 12.9 than in the United States after 2000, or periods, then our smoking rate trends percent in 2001. This compares to the smoking-reducing phenomena (other successfully control for the effect of U.S. over-65 population which than graphic warning labels) were less non-tax price changes on smoking rates. increased to 12.9 percent in 2009, up (Comment 224) One comment stated prevalent or effective in Canada than in from 12.4 percent in 2001. that FDA’s preliminary estimate of the (Response) FDA notes that the the United States before 2001. In the rule-induced smoking rate reduction comment’s finding (that individuals opposite cases, our model will produce was too high, in that it did not account over age 65 have a lower probability of an underestimate. In the absence of for the fact that Canada’s Tobacco Act’s being smokers than individuals aged 65 extensive high-quality data, we assume prohibitions on advertising and and below) does not necessarily imply that trends in smoking-reducing promotion came into full effect after the that aging causes individuals to cease phenomena (other than graphic warning introduction of the graphic cigarette smoking. Smoking rates are much lower labels) were about the same before and labels. The comment went on to state in the over-65 age category than in the after the year 2000 and about the same that other local regulations (such as 65-and-under category because smokers in Canada and the United States. restrictions on the retail display of are less likely than nonsmokers to (Comment 222) One comment stated tobacco products and advertisements) survive to and live past the age of 65. that FDA’s preliminary estimate of the that came into effect in Canada after the Possible reasons for the aging of a rule-induced smoking rate reduction year 2000 also may have had an effect nation’s population include: A decrease was too high, in that it did not account on smoking rates in Canada, and thereby in the birth rate, net emigration of for potential differences in responder would have inflated FDA’s estimate of relatively young people, net bias between United States and the expected rule-induced reduction in immigration of relatively old people, a Canadian surveys created by different smoking rates. decrease in the death rate of relatively levels of stigma associated with smoking (Response) From 2001 to 2008, at least old people, or an increase in the death in the two countries. 41 states, plus the District of Columbia, rate of relatively young people. If the (Response) FDA generates its estimate enacted or substantially updated changes in these population phenomena not only by comparing Canada with the legislation regarding tobacco advertising in the United States and Canada follow United States but also by comparing and promotion, youth access or the same pattern post-2000 as they did each country with itself. Specifically, sampling and distribution (Ref. 114). pre-2001, and if the relationship we find the difference between each FDA concludes, therefore, that the U.S. between smoking status and the country’s actual 1994 through 2009 experience provides a reasonably good population phenomena was also smoking rates with rates predicted by a control for the effect of local and relatively constant between the two time pre-2000 trend (which accounts for regional policy changes on national periods, then our smoking rate trends changes in cigarette taxes), and then smoking rates. successfully control for the effect of calculate how the average difference for (Comment 225) One comment stated population changes on smoking rates. 2001 through 2009 compares with the that FDA’s preliminary estimate of the (Of course, there is a correlation average difference for 1994 through rule-induced smoking rate reduction between smoking rates and death rates, 2000. The trend at least partially was too high, in that it failed to account but it operates with sufficient lag so as controls for any steady change over time for the fact that, in April 2001, the not to confound our results to a in responder bias within a given survey, Government of Canada launched a meaningful degree.) and the within-country comparison of Federal public education, outreach, and (Comment 227) Several comments pre-2001 and post-2000 rates controls mass media campaign that had a goal of suggested that the lack of statistical for any difference in responder bias reducing tobacco-related death and significance of FDA’s estimate of the between the two countries. disease among Canadians. effect of graphic warning labels on (Comment 223) One comment stated (Response) The U.S. experience Canada’s smoking rate implies that there that FDA’s preliminary estimate of the provides a reasonably good control for is no sound basis for concluding that the rule-induced smoking rate reduction the effect of media campaigns on proposed (and now final) rule’s benefits was too high, in that it did not account smoking rates because antismoking exceed costs and that this creates a

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violation of Executive Order 12866, how much cancer reduction will be higher estimates that appear in the which requires government agencies to effected by the graphic warning label scholarly literature. show the quantitative benefits exceed that depicts a baby being exposed to (Response) The comments making the quantitative cost from a regulation. secondhand smoke? this point have confused the life-years One comment further noted that FDA (Response) The research study lost for a lifetime smoker (compared did not, in the preliminary analysis, commissioned by FDA and included in with a nonsmoker or quitter) with the report whether its secondary the docket analyzes the reactions of measure that FDA needs for its analysis: methodology (in the Uncertainty consumers to each image. We cannot yet the adjusted life expectancy changes Analysis) produced an estimate that was know the effectiveness of each image on that make up the incremental effects of statistically significant. improving health outcomes (such as reduced smoking rates induced by the (Response) Executive Order 12866 avoidance of cancer) because the images final rule. states that: ‘‘Each agency shall assess have not yet appeared on cigarette Regarding life-years lost for a lifetime both the costs and the benefits of the packages or advertisements. Our best smoker (compared with a nonsmoker or intended regulation and, recognizing estimate of the images’ collective effect quitter), Sloan and coauthors’ estimates that some costs and benefits are difficult comes from Canada’s experience with a (Ref. 116) do not differ much from those to quantify, propose or adopt a collection of graphic warning labels. reported in other studies. Specifically, regulation only upon a reasoned (Comment 229) One comment stated Sloan et al. use results from the Taylor determination that the benefits of the that FDA should use worldwide data if et al. (Ref. 117) study, which reports intended regulation justify its costs.’’ its model of smoking reduction cannot that men who quit smoking at age 35 The point estimates indicate that the achieve statistical significance using gain 8.5 years of life expectancy and benefits of the rule justify the costs. only Canadian data. male never-smokers gain 10.5 years. In Although our analysis concludes, on (Response) FDA disagrees because, comparison, Doll et al. (Ref. 118) find this basis, that graphic warning labels culturally and geographically, Canada that if an individual avoids smoking will be effective at reducing smoking, provides a closer comparison for the entirely or quits at age 30, he increases we recognize there is large uncertainty United States than any other country. his life expectancy by 10 years. about the size of the effect. The lack of Moreover, in most countries, graphic Strandberg et al. (Ref. 119) find that statistical significance in FDA’s smoking warning labels have been implemented smoking shortens life expectancy for rate estimate reflects this uncertainty, as for only a few years, so any males by 7 to 10 years. well as the noisiness of data derived international additions to our data set Sloan et al. adjust the Taylor et al. from surveys and the small number of would likely contribute only a small results to account for the probability observations. number of data points while that an individual who smokes at a The use of a point estimate (which simultaneously necessitating the given age will quit sometime later in his indicates that graphic warning labels addition of extra variables (for example, or her life and for confounding factors, have decreased the smoking rate in geographic and time fixed effects) into such as differences in demographic Canada) is appropriate for the main the model, thus producing only a small characteristics and behaviors between portion of our analysis as long as we overall increase in degrees of freedom average smokers and nonsmokers. state clearly the lack of statistical and introducing potential errors due to Unlike Sloan et al., the studies cited in significance. Moreover, in the final more omitted variables. comments estimate the longevity gains analysis, we report the results of Monte (Comment 230) One comment stated to an individual from not smoking or Carlo simulations to better show the that FDA should use data from New from quitting at a given age but do not uncertainty. In doing so, we follow the York City’s experience with a graphic incorporate the probabilities of quitting advice of Vining and Weimer (Ref. 115): image media campaign, which reduced at each age or isolate the effect of ‘‘In view of the large number of smoking prevalence in that State by 1.4 cigarette consumption from other risk uncertain effects and shadow prices percentage points between 2005 and factors that tend to be correlated with involved in applying BCA [benefit-cost 2006. smoking. These studies are therefore analysis] to social policies, analysts (Response) FDA prefers the Canada- inappropriate for a regulatory impact must take special care in dealing with United States empirical model over a analysis estimating the incremental uncertainty. Rather than setting potential New York model both because effects of warning labels on lifetime estimates of effects equal to zero when Canada’s graphic warning policy is mortality consequences related to their estimates are statistically much more similar to the present rule smoking at a particular age. insignificant, a more appropriate than is New York’s television-based (Comment 232) Two comments approach is to take account of the campaign and because Canada’s policy expressed concern that Sloan and his uncertainty of these effects in Monte has been in place for a longer period of coauthors’ analysis is outdated. One of Carlo simulations.’’ time than New York’s, thus providing the comments went on to state that In addition to reporting Monte Carlo more data points. Furthermore, we note Sloan et al.’s literature review contains results, FDA has added additional that the New York experience would some studies that have been funded by discussion which will allow the likely yield a much lower (than 1.4 the tobacco industry and their ‘‘defense interested reader to examine our percentage points) estimate of the effect of rational addiction’’ may be empirical approaches in greater detail. of graphic images if only the excess undermining FDA’s effort to ‘‘ensure (Comment 228) One comment stated smoking rate changes, beyond New that its economic analysis is based on that FDA has no explicit measures York’s own trend and the changes empirical evidence, not theoretical linking each graphic warning label with experienced simultaneously in predictions from the rational addiction expected reductions in the risks of comparable cities or States, were model.’’ cigarette smoking. An example of such included. (Response) The Sloan et al. results linking would include answering the (Comment 231) Several comments that FDA uses are empirical, not following questions: What percentage of stated that Sloan and coauthors’ theoretical. In producing these smoking mothers blow smoke into their estimates of the number of life-years lost empirical results, Sloan and coauthors children’s faces, what is the probability by smokers are too low and use data from the 1990s; while this is that such behavior leads to cancer, and recommended that FDA use other, somewhat out-of-date, no analysis as

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detailed as that of Sloan et al. has been for 24-year-olds, these tables include provided only a very high-level and released more recently. The comment survival probability differences for cursory description of how it arrived at critiques some of the literature reviewed smokers and nonsmokers as early as the its estimate of reduced fire costs. by Sloan and coauthors but not the 25th birthday. (Response) For the final analysis, FDA methods Sloan et al. use to produce (Comment 238) One comment stated has expanded the discussion of how fire their life tables and other results. FDA that FDA’s assumptions regarding the loss reductions were calculated. has thus continued to use these results distribution of benefits over dissuaded (Comment 242) One comment stated in its Final Regulatory Impact Analysis. smokers’ lifetimes were incorrect. that FDA’s assumption that the (Comment 233) One comment stated (Response) In many cases, FDA’s introduction of self-extinguishing that the FDA provided in its preliminary sources reported smoking-related effects cigarettes would reduce the incidence of Analysis of Impacts virtually no details only as present values calculated with a smoking-related fires, with or without on its calculation of the benefit of single discount rate and for a particular the proposed rule, by 50 percent was expected life-years saved. age group. In order to expand our results arbitrary. (Response) FDA has added a more to other age groups or discount rates, it (Response) FDA agrees that the 50 detailed explanation to the final was necessary that we make percent assumption lacked empirical Analysis of Impacts. assumptions about the timing of support. For the final analysis, we use (Comment 234) One comment stated benefits. The absence of data prevents a data-driven estimate of the that, in its estimate of rule-induced FDA from confirming the degree of effectiveness of self-extinguishing emphysema reductions, FDA did not inaccuracy of our assumptions. For the cigarettes at preventing accidental fires. provide any documentation supporting final analysis, we have expanded our (Comment 243) Two comments stated its calculations. discussion of the likely direction of that FDA’s preliminary benefits analysis (Response) FDA has replaced its estimation error that may be caused by inappropriately excluded effects of the analysis of rule-induced emphysema our assumptions and, in one case, have rule on employee productivity. reductions with an analysis of general accounted for uncertainty related to (Response) FDA estimates morbidity health effects. Simultaneous with this assumption-making in our Monte Carlo and mortality effects using a change has been an expansion of our analysis. willingness-to-pay approach, estimated explanation of methodology. (Comment 239) One comment stated using the QALY metric as the base. (Comment 235) Several comments that Sloan et al.’s estimates of smoking- Willingness-to-pay to avoid morbidity, stated that morbidity effects other than attributable medical cost ($3,757 per as we use it in this analysis, includes emphysema were inappropriately female and $2,617 per male) are too low. the subjective value of avoiding an excluded from FDA’s preliminary The comment went on to recommend illness that affects mobility, self-care, analysis. the use of Thomas Hodgson’s estimate usual activities (including work), pain (Response) FDA has expanded its (Ref. 120) that this cost, in 2009 dollars or discomfort, and anxiety or morbidity estimates for the final and discounted at a 3 percent rate, is depression. These elements encompass Analysis of Impacts. Instead of $18,967. the value of market and nonmarket analyzing individual diseases, we have (Response) FDA believes that Sloan et productivity, and much else. Therefore, calculated rule-induced changes in al.’s estimates are to be preferred over in general, the value to smoking general health status (categorized as Hodgson’s because Hodgson does not employees of productivity effects is poor, fair, good, very good, or excellent). adjust for confounding effects (by implicitly included in both morbidity (Comment 236) Several comments analyzing ‘‘nonsmoking smokers,’’ a and mortality benefits; adding stated that benefits due to reductions in theoretical comparison group Sloan et productivity effects separately would secondhand smoke exposure and al. used to account for the effects of almost certainly lead to double counting mothers smoking during pregnancy other risky behaviors) and Sloan et al.’s of some of the benefits that accrue to were inappropriately excluded from data sets are more recent (from the dissuaded smokers. Economic theory FDA’s preliminary analysis. 1990s, rather than 1978 through 1988). predicts that, for employers, rule- (Response) FDA did not exclude The comment calculates the present- induced productivity effects generate no discussion of these effects from the dollar value of Hodgson’s medical cost long-term net benefit or cost because preliminary Analysis of Impacts, but we estimates using the medical component greater firm output will be offset by the were not able to quantify them due to of the consumer price index (CPI). For greater wages commanded by the more the difficulty of projecting future the Final Regulatory Impact Analysis, productive employees. secondhand smoke exposure levels from FDA will do the same because medical (Comment 244) One comment stated historical trends. Similarly, we were not costs have risen at a very different rate that ‘‘FDA’s analysis could benefit from able to project future reductions in than overall price levels and thus the a more fulsome explanation of the maternal smoking during pregnancy. In measure of inflation we used in the concept of QALY.’’ the Final Regulatory Impact Analysis, PRIA—the gross domestic product (Response) FDA has edited the final FDA has again been unable to quantify (GDP) deflator—is not the best available analysis accordingly. these benefits. option for updating medical costs. (Comment 245) FDA received several (Comment 237) One comment stated (Comment 240) One comment stated comments in regard to its downward that FDA’s analysis includes only health that FDA’s medical cost results were not adjustment of benefits estimates to benefits that accrue in the distant future, adjusted for inflation in the preliminary account for consumer surplus loss. One not immediate benefits of cessation or Analysis of Impacts. comment stated that such an adjustment avoided initiation. (Response) FDA’s medical cost should not be performed at all because (Response) FDA’s preliminary and estimates were adjusted for inflation in doing so requires an inaccurate final estimates of morbidity and the analysis of the proposed rule; assumption that smokers enjoy smoking. mortality effects include discounted however, our language on this issue was Three comments suggested that, if an totals of all future effects, both short- unclear and has been revised for the adjustment is performed, it should not term and long-term. For example, we analysis of the final rule. be 50 percent of gross health benefits, as obtained our life expectancy estimates (Comment 241) One comment stated suggested in FDA’s cited reference, from Sloan et al.’s life tables. Calculated that, in the preliminary analysis, FDA because that analysis assumes perfect

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rationality on the part of smokers. the comments, as already detailed in our analysis. We note, however, that the Another comment objected to the model response to comments on market failure. cost to taxpayers of Social Security are in the cited reference because it is very FDA agrees that the model we used in exactly offset by payments to Social simplified and stylized, with a linear the PRIA to explain changes in Security recipients or users of any other demand curve for smoking. One of the consumer surplus is not detailed government programs and services comments suggested FDA should enough to fully explain the assumptions funded with Social Security instead consider modern economic about consumer behavior underlying contributions, so this effect does not analyses of addiction that account for our estimates. In the revised analysis, generate a substantial net social cost or time inconsistencies in preferences, we have made some important changes benefit, with the exception of a probably including the work of Fritz Laux (Ref. in the presentation and the model used small deadweight loss. 109) or Jonathan Gruber and Botond to adjust our estimates and account for (Comment 249) One comment stated Ko¨szegi (Ref. 104). Another of the uncertainty. The key assumption made that the FDA’s preliminary analysis did comments suggested past regulatory explicit in the new model is that, on not, as required by the Office of changes and their effect on smoking be average, smokers are informed of, and Management and Budget, provide a used to measure demand and the lost able to internalize, some but not all year-by-year schedule of undiscounted surplus associated with those changes to health and life expectancy effects of cash flows that displays the timing of get a more empirically relevant measure their smoking. Full graphical and estimated rule-induced benefits. of the effect of the proposed rule. algebraic analyses have been added to (Response) FDA has added stream-of- (Response) The concept of consumer the final analysis, as has a discussion of benefits and -costs tables as appendices surplus is a basic tool of welfare the implications of Gruber and Ko¨szegi’s to the final analysis. work in the context of the new model. economics. If consumers respond to 4. Costs price, information, or other market Moreover, we have supplemented our In the analysis of the proposed rule, changes, there will be a change in benefits analysis with another approach, FDA focused on three main costs to consumer surplus. Although some in which we replace the steps of industry: The cost of changing cigarette economists describe consumer surplus summing all health effects and then package labels, the cost of conducting as a measure of the pleasure, subtracting lost consumer surplus with market testing for redesigned packages, satisfaction, or usefulness that a product a direct estimation of the value to and the cost of removing noncompliant provides to consumers, others simply smokers and potential smokers of point-of-sale advertising. FDA received say that whatever generates a demand cessation and avoided initiation, as several comments about costs, which for the product generates consumer shown by their willingness-to-pay for are summarized and responded to in the surplus. Moreover, how we qualitatively cessation programs. following paragraphs. describe consumer surplus does not (Comment 246) One comment stated that FDA’s preliminary benefits analysis (Comment 250) One comment took affect how it is measured—the issue with FDA’s characterization of the measurement is independent of the inappropriately excluded the effects of the rule on employer and government up-front costs associated with a major description. In an analysis of benefits label change as ‘‘large’’ by pointing out: based on willingness-to-pay, we cannot cleaning and maintenance costs. (Response) Reductions in the cost of ‘‘In the context of tobacco marketing, reject this tool and still fulfill our cleaning and maintenance were not with the companies spending $12.5 obligation to conduct a full and an included in the analysis because we did billion on marketing and promotion in objective economic analysis under not find reliable data. 2006, the amounts of money being Executive Orders 12866 and 13563. (Comment 247) One comment stated described are not ‘large.’’’ Although it does not affect our use of that FDA should conduct its uncertainty (Response) FDA has removed the term consumer surplus, we note that virtually analysis by performing a Monte Carlo ‘‘large.’’ all studies of the economics of smoking simulation. (Comment 251) One comment and addiction assume that smoking is (Response) FDA agrees and has asserted that the cost section was pleasurable to smokers. In their 2001 conducted a Monte Carlo simulation for systematically biased, and that all costs paper in The Quarterly Journal of the Final Regulatory Impact Analysis. were upper bound estimates as opposed Economics, Gruber and Ko¨szegi state (Comment 248) Two comments stated to ‘‘best’’ point estimates. that ‘‘smoking is a short-term pleasure’’ that FDA’s preliminary analysis (Response) FDA did not rely on upper (emphasis added) (Ref. 104). Economists inappropriately excluded the effects of bound estimates of any costs. The label Warner and Mendez state: ‘‘Many the rule on government-funded health change costs (the largest single cost members of the tobacco control care and Social Security expenditures. component FDA estimated) and the community dismiss the notion that (Response) In our analysis of the market testing costs have low, medium, smoking can be pleasurable. But those proposed rule, FDA did not exclude and high estimates. For the other cost people were never smokers or, if they government health care costs. In section components, we use our best estimates. were, have selective memory. For some VIII.C.6 of the PRIA, FDA reported (Comment 252) One comment argued smokers, the relief of withdrawal estimates of reductions in smoking- that because tobacco manufacturers symptoms might suffice as a ‘pleasure.’ related medical expenditures, paid for spend large amounts of money on But smokers derive much more from both by smokers themselves and by marketing activities, changing labels is their cigarettes, including everything nonsmokers via insurance premiums or, just an ordinary cost of business to from ‘mouth feel’ to the nicotine drug notably, taxes used to fund government them, and one that they can ‘‘write off.’’ rush, from relaxation to self-image health care. For the Distributional Furthermore, the comment argued that (think Marlboro Man), and from Effects portion of the Final Regulatory manufacturers can, to some extent, pass enhanced ability to concentrate to Impact Analysis, we have expanded the the costs on to consumers. The companionship’’ (Ref. 121). discussion of this effect of the rule to comment ends by stating: ‘‘It is not FDA’s approach to the economics of include greater detail. appropriate for the FDA to fear that its smoking treats it as an addiction and We have also added a discussion of regulatory efforts on this industry might draws on many economic theories of Social Security payments to the impose costs on them, and to use these addiction, including the studies cited in Distributional Effects section of the final costs as a reason not to proceed with its

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regulations. The agency is supposed to be taken away from other activities. (Response) The comment appears to act in the public interest, not the However, because this rule requires a misunderstand which cost elements are interest of a particular industry to set of 9 plates for the 9 different graphic affected by the need for nine labels. The protect it from protecting the public in labels, we manually adjust the model to term ‘‘Design costs,’’ as used in the the first place.’’ add back the 8 extra plates. labeling cost model, could refer to all (Response) The baseline expenditures (Comment 254) A comment asserted per-UPC costs associated with a labeling of the tobacco industry are irrelevant. that although there are 3,324 different change or specifically to graphic design There is a cost to society when its scarce UPCs, each UPC would not have to be labor costs. FDA inflated some, but not resources are expended to comply with redesigned because product varieties all, per-UPC labeling change costs by a this rule. The costs the comment refers within a brand family share essential factor of nine. to are economic or opportunity costs. trade dress and package design features. For graphic design labor costs, FDA Cost estimation is concerned with the The comment asserted that using a agrees that the part of the package value of the resources used to carry out number equal to 10 percent of the design that is under the control of the some activity, not their incidence (i.e., number of UPCs, 332, would still result manufacturer will probably be the same who ultimately pays), which is a in an overestimate of costs. regardless of which of the nine warning separate question. As acknowledged in (Response) Although products within labels is used. Therefore, the work of the proposed rule (section VIII.D, Costs), a brand family share certain package designing the new package label only although cigarette manufacturers are design features, the packages for has to be done once for each UPC; in the legally responsible for complying with different UPCs still contain unique cost estimates, graphic design labor this rule, the costs may be borne at least features. Thus, every individual UPC costs were not inflated by a factor of in part by tobacco consumers. The represents a separate design job. nine. potential for ‘‘passing costs on’’ to Furthermore, the labeling cost model Likewise, FDA assumed that the need consumers is a matter of economic presents an average cost per UPC of to incorporate nine different warnings on every package would have a incidence but does not negate the fact similar types within a product category, negligible impact on administrative that there are costs, nor does it change not the cost of changing one UPC. The labor costs, prepress labor costs, and those costs. model therefore accounts for the In the cost-benefit analysis we recordkeeping labor costs. These costs existence of brand families with similar estimate costs and benefits that accrue therefore were not inflated by a factor of label designs. to citizens and residents of the United nine. (Comment 255) A comment asserted States (Ref. 103) regardless of who we It was only for materials costs, which think may bear them. The ‘‘interest of a that FDA overestimates production and specifically includes prepress materials particular industry’’ is a subject we printing costs by ‘‘not accounting for the and printing plate costs, that FDA rightly leave to the ‘‘Distributional realities of how such work is actually assumed costs increased by a factor of Effects’’ section of our analysis. done.’’ The comment provided the nine due to the need to incorporate nine (Comment 253) A comment stated following quote from an unknown large separate warning labels. We employed that FDA should estimate ‘‘the marginal job printer: ‘‘In looking at the costs this assumption because nine times as cost of changing the warning labels that associated with each label, this might be many printing plates will be needed the cigarette companies would incur fairly accurate for 1 label, but they don’t upfront. accounting for ongoing expenses take into account the economies of (Comment 257) A comment argued associated with producing cigarette scale. After the first one, the second and that some of the costs attributed to the packages and assuming that the subsequent package costs will go down label change would be incurred on an companies implemented the new labels exponentially. The only costs that might ongoing basis. The example provided is using economical strategies.’’ remain static would be the costs of that printing plates wear out after a few (Response) The labeling cost model’s printing plates, which depending on million impressions and have to be baseline already accounts for ongoing how they print them, could be reduced replaced at regular intervals. The expenses associated with producing if they gang run several different comment argued our cost estimates need cigarette packages. Manufacturers packages of similar production runs to be adjusted to account for this. An change product labels at regular together on the same sheet. All the non- analysis follows which claims to intervals without regulatory changes in production costs would be amortized demonstrate that the average cigarette labeling requirements. Based on both over the whole.’’ label printing plate has to be replaced product type and compliance period, (Response) The labeling cost model every 3 weeks. the model provides an estimate of the does not measure the cost of changing (Response) The calculation provided percent of UPCs that can be coordinated one label, but the average cost when a in the comment contains errors. Once with a previously scheduled labeling large number of labels are changed at those errors are fixed, the calculation no change. For those UPCs, the only costs once. Due to resource constraints, the longer supports the assertion that assumed by the model are a small economic cost could be higher when a printing cylinders are being constantly fraction of the administrative labor cost large number of labels are changed at replaced, as discussed in the following and recordkeeping costs. once. The comment did not provide paragraphs. Furthermore, the model If anything, this approach taken by either alternate cost estimates for FDA accounts for possible coordination with the model quite possibly understates the to consider, or potential sources for previously scheduled labeling changes, labeling costs for so-called coordinated such data. which provides the most likely UPCs. For example, even though a (Comment 256) A comment asserted opportunity for cigarette manufacturers graphic designer can redesign a label to that design costs should not be inflated to avoid some of the incremental cost satisfy both regulatory and due to the requirement to use nine from new printing plates (cylinders). nonregulatory goals at once, such a different warnings because all warnings New cylinders must be engraved when redesign would plausibly take longer would occupy the same portion of each a nonregulatory labeling change takes than a redesign to satisfy only package, so the redesign would only place. Given the expense of the printing nonregulatory requirements, and time have to be done once regardless of cylinders, manufacturers would avoid devoted to regulatory compliance must which warning would be used. engraving new cylinders right before a

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nonregulatory labeling change. In other The new labeling cost model assumes market testing as a direct result of this words, we would expect some constant rush charges equal to 40 rule, the costs are attributable to this coordination between cylinder wear out percent for compliance periods of 3 to rule. Resources devoted to this market and nonregulatory changes. 15 months. In reality, rush charges are testing have an opportunity cost, so Rotogravure plates are the longest likely to decline continuously as the there is a social cost. We have been lasting, good for making millions of compliance period increases. The rush unable to obtain reliable data with labels. The comment assumed a life of charges under a 3-month compliance which to quantify potential costs only 3 million labels and did not justify period could exceed 40 percent, and the incurred to challenge the rule in this point estimate. For rotogravure, this rush charges for a 15-month compliance litigation. Lobbying costs associated estimate is too low. period are likely to be far less. FDA has with the repeal of the statute do not In attempting to determine weekly therefore retained the original represent incremental costs of this rule sales per UPC, the comment divided assumption of 10 percent rush charges and therefore are appropriately weekly cigarette sales (in packs) by their for a 15-month compliance period. excluded from the analysis. estimate of the number of brands, not by (Comment 259) One comment stated (Comment 261) A comment stated the number of UPCs. Dividing by the that FDA has underestimated costs that cigarette manufacturers and number of UPCs, even under the because of technical implementation retailers change advertisements and assumption that plates wear out after 3 difficulties associated with providing labels frequently and only the million labels, yields a life of 29 weeks for equal, random, simultaneous display incremental cost of replacements that for the average brand. Updating this of nine different images. would not have otherwise been made analysis for the revised number of (Response) FDA does not agree that should be attributed to this rule. The cigarette UPCs yields a life of 38 weeks there is a technical infeasibility. Similar comment asserted that this incremental for the average brand. requirements have been successfully cost is negligible. Additional calculations can be implemented in other countries. The (Response) FDA only looked at the performed for the ‘‘average’’ brand, but cost analysis for the label change cost of removing point-of-sale it is important to keep in mind that most includes administrative labor and advertisements. Other forms of cigarette brands are not average. A few products recordkeeping costs, part of which advertisements are now relatively rare. will have high volume. A large number would be associated with devising and The comment assumes that some or all of lesser-known products will have low implementing a method for ensuring manufacturers and retailers could volume. equal random display. However, FDA is perform the removal of noncompliant Because manufacturers will have to now persuaded that there will be some point-of-sale advertising at zero cost by buy nine plates up front for each UPC, ongoing cost associated with equal, coordinating it with the usual those nine plates would have a life of random display. In other words, once a replacement schedule for point-of-sale 346 weeks, or 6.6 years, based on the system for compliance is designed and advertising. Manufacturers and retailers comment’s assumptions about the life of implemented, it will require some work would only remove noncompliant a rotogravure plate and the updated to ensure continuing compliance with advertising early if the benefit from UPC count. Manufacturers of the equal, random display. Therefore, in the keeping them longer did not justify the average product would not wear out all Final Regulatory Impact Analysis FDA modest cost (between $12 and $198 per these plates before they changed labels has added recordkeeping costs and establishment) of removing the again for nonregulatory reasons. administrative costs as ongoing costs in (Comment 258) Multiple comments years 2 through 20 after the final rule advertising at the deadline. FDA expects argued that FDA should not include 10 takes effect. that the most likely response will be for percent rush charges in calculating the (Comment 260) Comments argued that most establishments to continue cost of changing labels in 15 months. In market testing costs undertaken by the displaying noncompliant particular, the argument was made that tobacco industry should not be counted. advertisements up until the enforcement cigarette manufacturers have known this Various arguments were presented: deadline and resources will therefore be was coming before publication of the Such costs would be beyond the expended to achieve compliance at the final rule. minimal cost required to implement the deadline. (Response) Although it is true that law ‘‘effectively and in good faith.’’ (Comment 262) One comment stated manufacturers have known this rule was Such costs would be incurred in order that the cost analysis needs to include coming, in some form, since the passage to ‘‘undermine the effect of reduced government revenue from lost of the Tobacco Control Act, it is only Congressionally-mandated warning taxes due to lowered cigarette sales. with the publication of the final rule labels.’’ Such costs would not be (Response) FDA notes that, leaving that they will know its exact form, i.e., societal costs at all, but distributional aside potential deadweight loss, there what the images will be. Tobacco effects because the cost to the tobacco are two principal effects of tax companies will need to see the final companies would be a benefit to reductions: Gains to former payers and images and the exact provisions of the employees or contractors paid to do the losses to former recipients. Because final rule before the bulk of the work for work. If FDA includes market testing these effects exactly offset each other, a labeling change can be undertaken. costs, it should also include legal fees there is no net social cost or benefit In evaluating the need for rush for potential challenges to this rule and associated with the reduction in excise charges, it is important to keep in mind lobbying fees to get the statute repealed. tax collections induced by the rule. As that the labeling model is designed to (Response) We do not simply estimate such, we discuss rule-induced changes measure the cost of changing a large the cost of minimal compliance. In in tax collections in the Distributional number of labels at once. Resources are benefit-cost analyses of regulations, we Effects section of our analysis (section scarce and a large number of labeling assume agents react to a new regulation XI.G.5 of this document). changes cannot be simultaneously by changing behavior in many ways. (Comment 263) One comment stated rushed without increasing costs. The analysis itself then compares the that the disturbing nature of the graphic The previous labeling cost model expected outcomes with and without warning labels will cause adverse assumed 10 percent rush charges for the rule. Regardless of whether the rule mental reactions in those who view compliance periods shorter than 2 years. requires it, if manufacturers conduct them, especially cashiers at cigarette-

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selling retail establishments because that could result from the proposed rule this permanence, FDA did not account they must handle these products daily. would reduce tax revenues beyond what for any job losses in the retail sector. (Response) FDA is not aware of any FDA reports in its analysis. The comment went on to state that scientific evidence that mental or (Response) At present, all State and convenience stores are highly emotional costs would be incurred by Federal cigarette taxes are applied per dependent on tobacco sales, both in the general public as a result of this unit, not ad valorem; therefore, changes terms of cigarette sales’ portion of profit regulation, and the comment did not in the pre-tax price of cigarettes will not margins and as a generator of customer provide any. change the total excise tax collection traffic to spur the sale of ancillary separately from changes caused by 5. Distributional Effects products. Even the small reductions in decreases in the quantity sold. Sales revenue caused by the graphic warning In the analysis of the proposed rule, taxes, on the other hand, are applied to label rule could cause retailers to reduce FDA estimated a variety of effects that cigarettes on the basis of price. FDA has employment, with some stores possibly are experienced as transfers away from not quantified the effect of the rule on going out of business entirely. some segments of society and as roughly sales tax collections, but we expect it to (Response) The portion of dissuaded equal transfers to other segments of be small, both because sales taxes make smokers’ budgets that would, in the society. FDA received several comments up a very small portion of total absence of the rule, have been spent on about these distributional effects. cigarette-related tax collections and cigarettes will, in the presence of the (Comment 264) One comment stated because any rule-induced change in rule, be spent on other goods and that FDA’s preliminary analysis of the cigarette prices is also likely to be small. services, thus creating jobs in other rule’s effect on tax collections ignored (Comment 267) One comment stated segments of the economy. Only the offsetting effects due to increased sales that, in its preliminary analysis, FDA difference between losses borne by of other taxable goods and services even failed to note that research indicates individuals losing cigarette-related jobs though the Joint Committee on Taxation that U.S. employment will increase if and gains realized by individuals estimates this offset at 25 percent of a smoking decreases. obtaining employment in other sectors policy’s direct effect. (Response) In the PRIA represents a net social cost. FDA (Response) FDA agrees with the (sectionVIII.F.2), FDA stated that believes this difference to be small and comment and has adjusted its analysis decreases in smoking may cause possibly negative (that is, the losses are of rule-induced changes in tax increases in national employment, less than the gains), as found by Warner collections accordingly. citing (Ref. 122) the same paper to et al. (Ref. 122). (Comment 265) One comment stated which the comment refers. (Comment 270) One comment stated that, in its preliminary analysis of the (Comment 268) One comment stated that, in its preliminary analysis, FDA rule’s impact on tax collection, FDA that FDA, in its preliminary analysis, incorrectly concluded that there would suggested that inelastic demand for estimated that the proposed rule would be no rule-induced losses experienced cigarettes means that some or all lost tax result in 500 to 600 displaced jobs by tobacco growers. The comment went revenue could be offset through higher among manufacturers, warehouses and on to state that FDA’s assumption that tax rates. The comment went on to note wholesalers but failed to note that these acreage taken out of tobacco production that FDA undertook no analysis of lost jobs probably would occur during a could be easily shifted to other crops, whether State and local governments period of high unemployment, when the with no net loss, is not consistent with could or would increase excise taxes on displaced individuals would likely have economic theory because economic cigarettes in response to the graphic difficulty obtaining new jobs with theory indicates that land currently warning label rule and that the political similar remuneration. The comment planted in tobacco is being used in its environment, as demonstrated by recent went on to state that the average highest-valued use. Another comment elections, may not be amenable to tax unemployment duration in November suggested that FDA work with the increases. 2010 was 34.5 weeks and that one Department of Agriculture on estimating (Response) FDA did not claim any could, by multiplying the average wage the impact of the rule on tobacco increases in State or Federal cigarette by the average duration of farmers. taxes are likely to occur. Instead, we unemployment, obtain a rough estimate (Response) FDA agrees that a merely pointed out that cigarette of lost wages. transition from tobacco cultivation to demand has been shown to be inelastic; (Response) The wages lost are not the the next-best option entails some loss therefore, an increase in tax levels will appropriate cost to attribute to the rule; for farmers, but only the difference increase revenue. For the final analysis, instead, we must include the difference between first- and second-best uses of we have removed some of our more between wages lost from tobacco-related land represents a net social cost in terms confusing language on this issue. We jobs and the value of next-best options. of reduced efficiency. continue to assume that tax rates will FDA is unable to quantify this (Comment 271) One comment stated rise at the rate of inflation because, difference. For instance, average that the requirement that cigarette without such an assumption, we need a unemployment tenure from late 2010 manufacturers print half of their reliable forecast of inflation in order to would likely give a skewed estimate of packaging with images supplied by the express the stream of future tax revenue length of rule-induced unemployment government would be a burden to all changes in current dollars. However, we because compliance with the rule is not cigarette companies, the costs of which have added discussion of alternative required until 2012. Unemployment would ultimately be paid by consumers. approaches, including the possible may change substantially between now (Response) FDA has estimated the forecasting of inflation using the and then, especially because the United cost to cigarette producers of adding difference between interest rates for States is currently in the early stages of graphic warning labels; however, we Treasury Inflation-Protected Securities recovery from a recession. have not assessed whether cigarette (TIPS) and standard Treasury bills. (Comment 269) One comment stated consumers or shareholders of cigarette- (Comment 266) One comment stated that manufacturing, warehouse, and producing firms will bear the burden of that, to the extent that State and local wholesaler jobs displaced by the rule the cost. We expect that the costs will excise taxes are based on the price of would be permanent losses to the be shared by consumers and producers cigarettes, increased price competition economy. In addition to failing to note but we are unable to estimate the

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portions borne by each group. In the 6. Impact on Small Entities labeling cost model, with which the cigarette market, increases in variable In the initial regulatory flexibility comment disagrees. FDA agrees that small tobacco costs are borne almost entirely by analysis, FDA considered the potential product manufacturers are more likely consumers. In the case of the addition effects on small cigarette manufactures to hire outside contractors for tasks of graphic warning labels, however, of having to change all cigarette labels required to comply with this rule. most of the cost does not vary with the in accordance with this rule. FDA also However, from a societal point of view, quantity of cigarettes produced. We considered the potential impact on it makes no difference to costs whether therefore expect that producers will be small retailers of having to remove a manufacturer conducts the functions unable to pass all of the cost on to noncompliant point-of-sale advertising. required for compliance in-house or consumers through increased prices. FDA received comments from industry Consumer prices could, however, be contracts them out. pertaining to these matters, which are (Comment 275) A comment argued affected in the long run. For example, summarized in the following that small manufacturers do not carry a one possibility is that some cigarette paragraphs. small inventory of supplies, but must product lines will be discontinued and (Comment 274) A comment stated buy materials in bulk to be cost effective this decrease in supply would lead to that FDA ‘‘grossly underestimates’’ (often as much as 6-months worth). The increased prices paid by consumers. costs, referring specifically to the comment stated therefore that it is FDA lacks the detailed market data that estimates of the label change costs and untrue that all label inventories will be would be necessary for predicting their impact on small manufacturers. exhausted during the 15-month which of these or other possible The comment argued that the necessary compliance period. Small outcomes would likely be realized. changes will cost at least $500,000 to $1 manufacturers will have to discard large (Comment 272) One comment argued million, including such factors as amounts of advertising and labeling that retailers must lose profit when package redesign, dye cuts, and the material. Another similar comment reallocating space away from cigarettes number of colors needed for the argued that small manufacturers artwork. Further, ‘‘these changes to other products because it was purchase long-term quantities of represent global changes for the suboptimal to make such an allocation ‘‘advertising pieces such as pole signs manufacturers’ products, and that in the absence of the rule. and shelf talkers,’’ in order to get better change will have a far greater effect on prices. FDA should take this into (Response) This comment ignores the the small manufacturer as opposed to account and give small manufacturers fact that the final rule will reduce larger entities.’’ Many aspects of time to use up existing inventories of demand for cigarettes and increase compliance will require the work of printed materials. The comment demand for other products. While it is outside contractors. suggested that manufacturers could clear by observation that allocating shelf (Response) It is not clear whether the provide FDA with inventory counts and space away from cigarettes to other comment intends to argue that the cost usage rates. products in the absence of this rule is on average $500,000 to $1 million per (Response) FDA believes the first would be suboptimal, this need not UPC, when many UPC labels are being comment combines two separate issues: imply that retailers’ profits will be lower changed at once, or that the total cost Label inventory assumptions (the matter after they optimally respond to changes would be at least this much per firm, at hand in the quote from the in the demand for cigarettes and the among some subset of small preliminary analysis) and advertising demand for other products. manufacturers. FDA does not agree that inventory assumptions. (Comment 273) Some comments the average cost per UPC could be FDA stands by its conclusion that the argued that retailers (including small nearly this high. Although FDA costs of discarded label inventory will retailers such as convenience stores) estimates much higher total costs for the be small under a 15-month compliance may not be able to simply shift shelf average small manufacturer, $500,000 to period. With modern just-in-time space to other goods. $1 million could describe the total costs inventory control methods, firms keep for a subset of especially small far less inventory on hand than in (Response) FDA argued in the manufacturers. decades past. However, rather than distributional effects section of the The cost estimate with which the assume that there is zero cost for proposed rule, section VIII.F.3, that the comment takes issue was based on a discarded inventory, FDA will accept retail sector (as a whole) will shift shelf combination of the old FDA labeling the new labeling cost model’s default space to other products to take cost model and early estimates of some assumptions regarding discarded advantage of the increase in demand for values from the new FDA labeling cost inventory. This assumption results in a noncigarette products. FDA model. Costs have been updated in the low inventory cost being attributed to acknowledges that this substitution may analysis for the final rule to more fully this final rule, as very little inventory is not take place wholly within each retail reflect the estimates of the new model. expected to remain after a 15-month establishment. If cigarette-reliant Interviews with manufacturers and compliance period. While it may be the retailers have some (but less than trade associations were conducted in case that some small manufacturers complete) success shifting shelf space to the process of building the new model. keep large amounts of inventory on take advantage of the increase in FDA believes the model provides the hand, the evidence used to construct the demand for noncigarette products, they best estimate of the average cost of labeling cost model implies that most will suffer an overall loss in revenue changing a product label. FDA inflates manufacturers would not have much (if that is less than their loss of cigarette materials costs by a factor of nine to any) label inventory remaining after 15 sales revenue. Other parts of the retail account for the requirement to use nine months and the output of the labeling sector would gain sales. This would be separate warnings. model accurately represents the average a purely distributional effect within the The comment also argued that FDA inventory cost. retail sector. Such an effect would be has underestimated the costs to small While it is possible that some small because this rule is only projected businesses but is not specific enough manufacturers will have some point-of- to reduce cigarette consumption by less about whether there are additional sale advertising materials in inventory than one quarter of a percent. factors, beyond the results of the that will be discarded as a result of this

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rule, FDA doubts that this inventory sales and loss of revenue from ancillary we do not attempt to choose among the cost is substantial. Manufacturers will products, and that this effect of the rule many models of smoking and addiction have 15 months to use up existing on small entities needs to be reflected in that potentially cause market failure, but inventory. Cigarette manufacturers are the analysis. Beyond the effect on the the models have similar policy known to be sophisticated advertisers, retailers themselves, closure of implications. and effective advertising changes to convenience stores would result in loss D. Benefits reflect the times. Therefore, the value of of convenience to nearby customers and existing advertisements would decline could also adversely affect suppliers. We estimate the benefits of the final over time as they become more dated (Response) Although in the small rule by comparing expected life-cycle and less effective. Additionally, the entity analysis we are only able to events of smokers with those of comments themselves do not provide quantify the cost of removing nonsmokers. Nonsmokers tend to live data with which to estimate any effect noncompliant advertising, we longer and develop fewer cancers, that may exist. acknowledge that small retailers selling cardiovascular, pulmonary, and other (Comment 276) One comment cigarettes could also lose some net sales diseases, so the benefits in our analysis estimated that the label change cost revenue (to other retailers), to the extent include the discounted value of life- would be between $2.1 million and $5.5 that shifting shelf space to other goods years gained, health status million per average small tobacco less than fully offsets the reduction in improvements and medical services product manufacturer, based on an revenue from cigarettes. We expect any freed for other uses. We also include an average number of UPCs per firm of 44. such loss of revenue to be modest estimate of the monetary value of the The comment asserted that small because the expected reduction in property and lives saved as a result of manufacturers cannot absorb the cost of cigarette consumption is modest to the rule-induced reduction in the changing all their cigarette labels and begin with. Convenience store closures number of accidental fires caused by many will leave the cigarette as a result of this final rule are therefore smoking. There are other benefits, such manufacturing business. Two relief unlikely. as reductions in nonsmokers’ morbidity options were suggested: Phasing in the (Comment 278) One comment and mortality associated with both rotational warnings over a longer period recommended that FDA reconsider passive smoking and mothers smoking of time or running the warnings exempting small cigarette producers. during pregnancy, that are likely sequentially rather than simultaneously. (Response) The initial regulatory generated by the final rule, but FDA has (Response) According to this flexibility analysis considered been unable to obtain reliable data with comment, small tobacco product exempting small manufacturers from the which to quantify them. In particular, manufacturers have fewer UPCs each label change requirements as a relief we were not able to project future levels than FDA originally estimated. If the option. Exempting small manufacturers of exposure to secondhand smoke from UPC estimate from the comment holds, from all or part of this regulation would historical trends, nor predict future the compliance costs for small firms cause a significant proportion of decreases in maternal smoking during would be lower than FDA originally consumers to be exposed to cigarette pregnancy. estimated. FDA has retained the original packages or advertising lacking the new 1. Reduced Cigarette Smoking Rates method for estimating the number of graphic warnings. In 2008, the UPCs for small firms so as to take care combined market share of all but the The changes outlined in this rule are not to understate the burden on them. four largest firms was 10.3 percent (Ref. projected to decrease smoking initiation FDA acknowledges that this rule may 123). This situation would be and increase smoking cessation. For put some small manufacturers at risk of inconsistent with the public health each of the first 20 years of the rule’s going out of business. However, we do objective of the rule as well as FDA’s implementation (2012 through 2031),12 not have the information necessary to statutory mandate. FDA calculates the predicted decrease estimate this risk. In the initial in the number of U.S. smokers by regulatory flexibility analysis, FDA C. Need for the Rule multiplying together the following: considered the relief that would be Written with the goal of ameliorating (a) The estimated effect (percentage provided by allowing small (or all) the large toll on public health that is point change) of cigarette warning labels tobacco product manufacturers directly attributable to the consumption on the national cigarette smoking rate additional time to comply with the rule, of tobacco, the Tobacco Control Act and even though this not in keeping with the mandates the publication of this rule. (b) The population in a particular year statutory mandate. Running nine Section 201 of the Tobacco Control Act in the absence of the regulation (as warnings sequentially rather than in modifies section 4 of FCLAA to require projected by the U.S. Census Bureau). parallel is a complicated alternative for that nine new health warning To obtain estimates of the effect of which it is difficult to estimate the statements, along with color graphics cigarette warning labels on smoking amount of relief provided. A very large depicting the negative health rates (item (a) in the list above), we look reduction in costs would only consequences of smoking, appear on to the experience of Canada, which has materialize if the warnings were only cigarette packages and in cigarette required the use of graphic warning changed as often as the usual frequency advertisements. As discussed in detail labels since December 2000 (Ref. 124). of nonregulatory label changes (every in FDA’s response to comments in The advantage of this approach lies in couple of years). However, FDA has section XI.B.2 of this document, the our ability to observe actual consumer now included an analysis of the economics literature suggests several behavior—in the form of smoking potential impact of a related relief sources of market failure 11 that the new rates—before and after a graphic option, that of letting small graphic warning labels will address; warning label requirement went into manufacturers randomly assign one these include myopia, lack of salience, label to each distinct UPC. time inconsistency, and incomplete 12 The effects of antismoking policies occur over (Comment 277) Some comments a long period of time, so we want to include at least information. In the following analysis, one full generation in our analysis. Using a 20-year argued that some small retailers, such as time horizon allows us to do this while still convenience stores, may go out of 11 A situation in which a market left to itself does avoiding the extreme uncertainty regarding effects business as a result of reduced cigarette not allocate resources efficiently. occurring in the more distant future.

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effect. The warning labels to be required Health Interview Survey (Ref. 128) and pre-2001 smoking rate trends for both in the final rule are generally similar to from ‘‘Health, United States, 2005,’’ the United States and Canada. Because those developed by Health Canada and published by the National Center for tax-induced changes in the price of authorities in other foreign countries. As Health Statistics (Ref. 129). We used the cigarettes have been shown to in Canada, the labels required by the results from these two reports to substantially reduce smoking, in each rule will occupy at least half the front calculate the United States-Canada trend estimation we include the effects and rear display panels of a cigarette smoking rate difference for individual of Federal and State or provincial package. Moreover, under the rule, there years. As shown in table 4 of this cigarette tax changes on national will be a mix of warning statements and document, the smoking rate in Canada smoking rates. (After decreasing images that depict the negative was, as of the most recent survey substantially in the early 1990s, consequences of smoking. Although the estimates, more than three percentage Canada’s real average cigarette excise rule will follow much the same points lower than the rate in the United tax level grew by 9 percent between approach as the Canadian warning label States and approximately seven 1995 and 2000 and by 123 percent requirements, it will differ in some percentage points lower than Canada’s between 2001 and 2009. Real average ways: Canada has 16 labels in rotation, own smoking rate in the year before cigarette tax levels in the United States rather than 9; warning statements graphic warning labels were grew by 29 percent between 1995 and appear in English on one side of a implemented in that country. It would 2000 and by 117 percent between 2001 Canadian package and in French on the be unjustified, however, to conclude and 2009.) Using the estimated trends, other; and health and cessation that the introduction of graphic warning we predict smoking rates for the United information is included on leaflets labels in the United States will cause within Canadian cigarette packages (Ref. the U.S. smoking rate to fall by seven, States and Canada, and the difference 125). These details, combined with or even the three percentage points between them, for years up to and general differences in legal and social needed to reach the Canadian rate. including 2009. We then subtract the trends, indicate that Canada’s Many factors, such as tobacco predicted United States-Canada experience with warning labels can give advertising restrictions, youth access smoking rate differences from the actual only a general idea of the changes in restrictions, educational campaigns differences observed in the data. smoking rates to be expected as a result regarding the health effects of smoking, Implicit in this method is the of the rule. In addition, other smoking restrictions on smoking in indoor public assumption that these otherwise- control initiatives, including new places, and taxes on tobacco products unexplained differences may be restrictions on smoking in indoor public have influenced smoking rates in the attributed solely to the presence in places, also occurred in both the United two countries. In order to estimate the Canada of graphic warning labels. We States and Canada during the period of incremental effect of the present rule, do not account for potential our analysis. These and other we need to isolate the impact of graphic confounding variables or for possible confounding factors make our estimate warning labels on the Canadian smoking substitution by consumers from of the effect of new graphic warning rate. cigarettes to other products (such as labels highly uncertain. In order to accomplish this, as little cigars) that may produce similar Health Canada (Refs. 126 and 127) discussed in detail in Technical health effects; our method is therefore a reports Canadian smoking rates for ages Appendix X1, we begin by using data rudimentary approach to estimating the 15 and above for years from 1994 from Health Canada (Refs. 126 and 127), smoking reduction that will be effected through 2009. FDA obtained smoking the National Center for Health Statistics by the new graphic warning labels and rates for adults, aged 18 and above, in (Ref. 129), and the National Health may be producing results that are off by the United States from the National Interview Survey (Ref. 128) to estimate one or more orders of magnitude.

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Using this rudimentary approach, participation-related probability of the particular year’s newly exposed FDA estimates that the average success. Warner et al. (Ref. 131) report cohort (consisting of 18-year-olds and unexplained difference between United that the choke price, or the price at new immigrants). This results in a States and Canadian national smoking which no smokers would participate in present value of net intrapersonal rates is 0.088 percentage points higher cessation programs, may be around $350 benefits of $370.3 million, calculated for the 2001 through 2009 period than (in 2000 dollars), while a maximum of with a 3-percent discount rate, or $322.4 for 1994 through 2000. Applying this 10 percent of the smoking population million, calculated with a 7-percent estimate to population projections (Ref. would participate in cessation programs discount rate. 130 provides annual projections only even if those programs had a money While these values can provide rough through 2030, so we assume cohort price of zero. With a linear demand estimates of the benefits of the final populations will remain the same from curve, these parameters produce an rule, there are several reasons to believe 2030 to 2031); summing over all age average willingness-to-pay among they are only approximations and groups yields an estimate that the rule potential cessation program participants probably reflect lower bounds. First, we will reduce (either through cessation or of $175. Warner and coauthors report are implicitly assuming that the value of avoided initiation) the United States’ that approximately 15 percent of avoided smoking initiation is equal to smoking population by approximately smoking cessation program participants the value of cessation and that the value 213,000 in 2013, with the total decrease successfully quit without eventual of cessation is equal across the entire rising to approximately 246,000 in 2031 relapse. These parameters indicate that smoking population. In fact, we have due to the predicted smoking rate the average value of cessation is $175/ willingness-to-pay data only from those decrease being applied to a growing 0.15 = $1,167, or $1,444 when updated smokers who are potential participants population. FDA has not quantified for inflation (using Ref. 132). in cessation programs. The value of rule-induced decreases in cigarette We estimate in section XI.D.1 of this avoided initiation is likely much higher consumption among smokers who do document that the final graphic warning than the value of cessation, which not quit entirely, although such label rule would reduce the U.S. adult would tend to make the present decreases have the potential to improve smoking population by 213,000 in 2013. estimates of rule-induced benefits too health outcomes for affected In the absence of the rule, the baseline low. A second reason willingness-to-pay individuals. 2013 smoking population would be for cessation programs represents a 2. Quantifying Benefits That Accrue to approximately 49.5 million, so a lower bound on the rule’s benefits is Dissuaded Smokers decrease of 213,000 represents a 0.43 because it captures only the percent effectiveness of graphic warning misinformation and time-inconsistent a. Smokers’ willingness-to-pay for labels. The value to an individual preferences that smokers themselves cessation programs. One method for smoker of graphic warning labels equals recognize and act upon via participation estimating dissuaded smokers’ net their effectiveness multiplied by the in cessation programs. internal benefits involves using the value of cessation, or 0.0043*$1,444 = b. Gross and net health benefits. We amount smokers are willing to pay to $6.22. Multiplying by the predicted now turn to the literature on time participate in cessation programs. This 2013 smoking population yields an inconsistency, which is one of the willingness-to-pay will equal the value aggregate value of the rule of $6.22*49.5 principal forms of market failure of cessation (i.e., the value of health and million = $307.9 million. For each year relevant to tobacco, to develop an other benefits of cessation minus any from 2014 to 2031, we perform an alternative approach to estimating rule- value that smokers attribute to the analogous calculation, but we replace induced benefits that accrue to activity of smoking) multiplied by the the entire smoking population with only dissuaded smokers. The papers we will

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discuss use the term ‘‘optimal The applicability of any of the year-old typical and nonsmoking internality tax,’’ but the key point is that suggested net-to-gross internal benefits smokers, life expectancy increases from taxes and cessation programs are both ratios requires an estimate of the gross 49.8 to 54.2 years, producing a gain of tools that cause a reduction in smoking, benefits realized by individuals who are 4.4 undiscounted years. The gap and the dollar prices of those tools dissuaded from smoking. Gruber and between male and female life represent estimates of the amounts that Ko¨szegi admit that their $30.45 per pack expectancy results may be due to smokers would be willing to pay to gain estimate is not exhaustive, so we now different physiological responses to the net intrapersonal benefits associated turn to quantifying morbidity, mortality, equal amounts of smoking, different with smoking reduction. and other effects of smoking cessation lifetime cessation patterns, or different Gruber and Ko¨szegi (Ref. 104) and avoided initiation. smoking intensities. Taylor et al. (Ref. estimate the tax rate that would allow i. Expected life-years saved. The 117), for instance, find that male time-inconsistent smokers to consume largest health consequence of smoking smokers are more likely than female the quantity that would be optimal is the increased rate of mortality from smokers to consume more than a pack under perfect rationality and in the pulmonary and cardiovascular disease, a day. Sloan et al. do not report how absence of other forms of market failure. cancer, and certain other illnesses. As a much of the male-female difference in They first estimate an internal health result, the largest benefits of this rule their estimated life expectancy effects cost of $30.45 per pack. From this cost, stem from the increased life may be attributed to each possible they calculate an internality tax that expectancies for those individuals who, mechanism. In spite of this limitation, ranges from $0.98 to $2.89 (depending in the absence of the rule, would be FDA considers Sloan et al.’s on technical parameters of their model), smokers and thus susceptible to methodology to be the most suitable in with an average of $2.17. Because the premature mortality from one of these the literature for purposes of the present demand for smoking is downward- often-fatal diseases. We calculate the analysis due to other studies’ omissions sloping, a decrease in the smoking rate number of life-years saved using of a nonsmoking smoker adjustment, a will decrease the optimal internality tax. differences in the probabilities of lifetime cessation probability In Technical Appendix X5, we account survival for smokers and nonsmokers. adjustment, or both. for this complication. Because we find Sloan et al. (Ref. 116) construct life We assume that each person who that Gruber and Ko¨szegi’s results imply tables for various categories of reaches ages 18 to 24 during the 20 that net internal benefits of the rule individuals, including ‘‘nonsmoking years (2012 to 2031) of our analysis and is dissuaded from smoking extends his equal roughly 7 (=100¥93) percent of smokers’’ and typical 24-year-old or her life by the gender-specific amount the gross internal (health) benefits, the smokers. A nonsmoking smoker is Sloan and coauthors report. For older average optimal tax over the relevant someone who does not use cigarettes individuals, whose post-smoking portion of the demand curve is but otherwise exhibits the lifestyle and cessation survival probabilities cannot 0.07*$30.45 = $2.05 per pack. personal characteristics of the average be plausibly assumed to equal those of Multiplying this optimal tax by the smoker.13 A typical 24-year-old smoker individuals who were nonsmokers at predicted rule-induced reduction in does not necessarily smoke for his or age 24, we predict life extensions using cigarette consumption would yield an her entire life, but instead faces former smoker life tables that we estimate of benefits that accrue to cessation probabilities that are in line construct using Sloan et al.’s results and dissuaded smokers. with values observed for all ages in the cessation probabilities from the 1998 In other writings, Gruber (Ref. 133) National Health Interview Survey; the life expectancy effects of cessation at National Health Interview Survey (Ref. suggests that, because his work with 128). The details of these adjustments Ko¨szegi considered only a limited older ages are netted out of life expectancy effects of avoiding smoking appear in Technical Appendix X2. degree of time inconsistency, the ii. Benefits of reduced premature at age 24 (results reported below). Sloan optimal internality tax on cigarettes mortality. OMB Circular A–4 (Ref. 103) et al.’s life tables allow us to calculate could be much higher than the level advises that the best means of valuing how many additional deaths, per estimated with Ko¨szegi, perhaps benefits of reduced fatalities is to 100,000 population, may be expected between 5 and 10 dollars per pack. measure the affected group’s among typical smokers than among (Even this amount does not, however, willingness-to-pay to avoid fatal risks. nonsmoking smokers between the 24th account for other forms of market failure Three life-year values (also known as that might be relevant to tobacco use.) and 25th birthdays, the 25th and 26th, values of a statistical life-year, or VSLY) The midpoint of the 5 to 10 dollar range, and so on until the 100th birthday. used frequently in the literature and in $7.50, yields a net internal benefits (FDA assumes that differences in yearly previous analyses are $100,000, result equal to roughly 24 percent of survival probabilities for smokers and $200,000, and $300,000 (Refs. 134 and rule-induced internal health benefits. nonsmokers are negligible below age 24 135; 74 FR 33030, July 9, 2009), which Other models of addiction and smoking and above age 100.) we update to $106,308, $212,615, and Overall, Sloan et al. find that an would imply different net internal $318,923 in 2009 prices. These values benefits, depending on the implied average (or what Sloan et al. call constitute our estimates of willingness- severity of the market failure. One ‘‘typical’’) 24-year-old female smoker to-pay for a year of life preserved in the comment on the proposed rule, from a can expect to live another 55.5 years, present. The economic assessment of a scholar who has done a great deal of while a comparable nonsmoker can future life-year requires discounting its professional research on the economics expect another 57.8 years of life, value to make it commensurate with the of smoking, suggested that smokers producing an overall regulation-induced value of present events. As required by would assess the value of quitting gain of 2.4 undiscounted life-years per OMB Circular A–4, we use 3-percent smoking as 90 percent of the value of individual who is prevented from and 7-percent discount rates to calculate health gained from smoking. Although starting to smoke. Comparing male 24- the present value of the life-years we this and other public comments predict will be saved. 13 In their multivariate regression analysis, Sloan suggested high ratios of net to gross et al. control for alcohol intake, body mass index, For each dissuaded smoker, we health benefits, none provided evidence financial planning horizon, race, education, and multiply a VSLY by the relevant age- supporting their suggestions. marital status. and gender-specific life extension and

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then discount appropriately to arrive at smoking avoidance) to $363,333 (for a smokers and discounting the results a per-person value of reduced mortality. male applying a VSLY of $318,923 and back to year 2011 yields estimates of For 24-year-olds, this value ranges from a 3-percent discount rate to his 4.4 life- rule-induced mortality benefits that $9,280 (for a female applying a VSLY of years gained due to smoking avoidance). range from $1.45 to $22.56 billion. $106,308 and a 7-percent discount rate Multiplying the per-person values by to her 2.4 life-years gained due to the predicted number of dissuaded

These totals may understate the full individuals to the harmful effects of cardiovascular disease, and other value of rule-induced reductions in cigarettes, and (3) the effect of cigarette smoking-caused illnesses. Cigarette mortality because they do not account exposure on nonsmokers’ mortality. The smoking also imposes costs on smokers for increasing trends in life expectancy. ever-changing level of nonsmoker in the form of pain, distress, and Sloan et al.’s results, from which our cigarette exposure means that a simple impaired function even before these mortality estimates are derived, are extrapolation from the recent past illnesses cause fatalities. As with based on data from the late 1990s. Arias provides a much less reliable prediction premature death, individuals are (Ref. 136) reports that between 1999 to of the near future for element (2) than assumed to be willing to give up 2001 and 2006 (the most recent year for for other pieces of this analysis. Any valuable resources in order to avoid which life tables have been developed), estimation of (2) would therefore be reductions in quality of life associated life expectancy at age 25 increased from highly data-intensive and subject to an with smoking-related illnesses. 50.54 to 51.5 years, or 1.90 percent, for unacceptable level of potential error. In Sloan et al. (Ref. 116) examine survey males and from 55.41 to 56.1 years, or general, FDA has been unable to obtain respondents’ self-reported health status 1.25 percent, for females. If these data with which to solve this problem; (which can be categorized as poor, fair, percentage changes are approximately it is for this reason that we do not good, very good, or excellent) and correct for the typical smoker and quantify health benefits that will accrue estimate that a 24-year-old smoker can nonsmoking smoker populations, then to individuals other than smokers expect, on average, an extra 1.086 our estimates of smoking-related life themselves. discounted years (using a discount rate expectancy effects would need to be We do, however, note that the Robert of 3 percent and averaging over Sloan’s adjusted upward accordingly (or Wood Johnson Foundation (Ref. 137) estimates for males and females) or perhaps by different percentages reports that the percentage of the U.S. 0.521 discounted years (using a because life expectancy has continued population living in homes where discount rate of 7 percent and again to change since 2006). smoking was permitted decreased from averaging over males and females) of A further reason to believe the values 56.9 percent in 1992 to 1993 to 20.9 fair or poor health over his or her in table 5 of this document may be percent in 2006 to 2007. This may lifetime, as compared with a underestimates is their lack of indicate that the ratio of spouse and nonsmoking smoker. quantification of any reduction in either infant mortality effects (related to In order to quantify the value of rule- the external effects attributable to passive smoking) to smoker mortality induced reductions in years spent in fair passive smoking or the infant and child effects is now approximately 36.7 (= or poor health, we scale our estimates of fatalities caused by mothers smoking 20.9/56.9) percent as large as the 26.3 the VSLY ($106,308, $212,615, and during pregnancy. Sloan et al. (Ref. 116) percent ratio derived from Sloan et al.’s $318,923, as discussed in the previous indicate that, historically, the inclusion results (which were calculated using section of this document) by a ratio of spouse and infant deaths from data from the 1990s). Using this very representing the trade-off individuals exposure to secondhand smoke or rough approximation yields a present are willing to make between time spent mothers smoking while pregnant value of spouse and infant mortality in best-possible and lesser levels of increased estimates of smoking’s benefits ranging from $140.3 million (= health. Nyman et al. (Ref. 138) estimate mortality effects by approximately 26.3 0.263*0.367*$1.45 billion) to $2.18 this trade-off by matching survey percent. We do not incorporate this billion (= 0.263*0.367*$22.56 billion). respondents’ self-reported subjective adjustment into our analysis, however, Although there are serious weaknesses health statuses with their EuroQol–5D because recent restrictions on indoor with this estimation approach that make (EQ–5D) health index scores. The EQ– public smoking and educational it inappropriate to include in our overall 5D survey responses—to questions campaigns have significantly reduced, benefits analysis, the results may give a about five areas of health, including though not eliminated, nonsmokers’ sense of the magnitude of mortality mobility, self-care, pain, anxiety, and exposure to secondhand smoke. In other benefits generated by the rule via ability to perform usual activities—are words, an analysis of the rule’s impact reductions in spousal and fetal smoking mapped so that a score of one represents on health benefits that accrue to exposure. best measurable health, a score of zero individuals other than smokers iii. Improved health status (or represents death, and fractional values themselves requires three pieces of reduced morbidity). In the previous represent intermediate levels of health. estimation: (1) The rule-induced change section, we estimated the benefits that Nyman et al.’s analysis indicates that, in the number of U.S. smokers, (2) the will accrue as a result of the rule- relative to the health index score of an relationship between the number of induced reduction in premature deaths individual with excellent health, a very smokers and exposure of nonsmoking from cancer, pulmonary and good health score will be lower by 0.03,

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a good health score will be lower by very good, or excellent to fair or poor is females and 2.33 million males in 2031. 0.078, a fair health score will be lower equal, on average, to the harm FDA’s estimate of a 0.088 percentage by 0.194 and a poor health score will be experienced by an individual in the best point reduction in the U.S. smoking rate lower by 0.392. Weighting by Nyman et possible health whose death is hastened thus translates to a decrease of 3,906 24- al.’s reported percentages of by 0.208 years. Thus, the welfare effect year-old smokers in 2013, with the respondents in each health category, of smoking-related health status changes decrease rising to approximately 4,154 FDA finds that the health index score may be found by multiplying a plausible in 2037. Multiplying these estimates of for the average individual in good, very life-year value (such as $106,308, the rule-induced reduction in the good, or excellent health is lower than $212,615, or $318,923) by 0.208; this number of smokers by Sloan et al.’s the index for excellent health by 0.036 multiplication yields estimates of predictions of discounted reduced and the health index score for the $21,800, $43,600, and $65,400 for the health-years per smoker and the quality- average individual in fair or poor health amounts individuals are willing to pay of-life loss per year of fair or poor health is lower than the index for excellent to avoid a year of reduced health status. health by 0.244; the difference between The U.S. Census Bureau (Ref. 130) derived from Nyman et al., and these averages is 0.208. This result may predicts that the nation’s 24-year-old discounting appropriately, yields a rule- be interpreted as follows: The harm cohort will be 2.17 million females and induced welfare gain of $0.5 to $4.7 experienced by an individual whose 2.25 million males in 2013 and rise billion. Detailed results appear in table health changes, for 1 year, from good, steadily to approximately 2.25 million 6 of this document.

Sloan and coauthors do not report the the benefits experienced by individuals the most recent medical care CPI (Ref. effect of smoking on fair or poor health who quit at age 24 and below or who 140). years for dissuaded smokers of ages avoid smoking initiation altogether. Sloan and coauthors do not report other than 24; in the absence of a Third, in a study conducted with a expected medical costs for former reliable estimate of the morbidity effect methodology very different from the one smokers, so estimating benefits for of smoking cessation for individuals used in this regulatory impact analysis, individuals aged 25 and above who aged 25 and above, FDA takes the Stewart et al. (Ref. 139) estimate that cease smoking as a result of the rule conservative approach of estimating smoking avoidance can increase requires some assumptions. For this benefits only for adults who are at or discounted life expectancy by 1.73 years analysis, we assume that smoking- below that age sometime during the first and quality-adjusted life expectancy by related annual excess medical costs are 20 years of the rule’s implementation. 2.17 years; this implies that, in the the same whether smokers are compared Smoking cessation brought about by this realm of smoking avoidance, the with never-smokers or former smokers rule will improve health status, in some magnitude of morbidity benefits is and that the payments, reported by cases substantially, for many around 25 percent of the magnitude of Sloan et al. as present values for 24- individuals who are over age 24 at the mortality benefits. Compared with this year-olds, are distributed equally from time of the rule’s implementation. Our independent evidence, FDA’s morbidity ages 24 to 100 (in other words, we omission of these benefits to older results, which are 15.3 percent annualize Sloan et al.’s estimated individuals produces an underestimate (undiscounted), 21.0 percent present value over the 77 years between of the rule’s morbidity benefits (which (discounted at a 3-percent rate) or 34.5 ages 24 and 100). With these is why we describe our estimate as percent (discounted at a 7-percent rate) assumptions, given FDA’s projected 20- conservative) but there are several as large as mortality effects, appear to be year reductions in smoking prevalence, reasons to believe the magnitude of the only moderate underestimates. we anticipate that the regulation will underestimate may not be iv. Medical services. Sloan et al. (Ref. cause smoking-related medical overwhelmingly large. First, although 116) estimate that smokers use more expenditures to fall by $859.9 million, individuals aged 24 and below make up medical services over their life cycles of which $458.2 million will be realized a fairly small portion of the smokers we than do comparable nonsmokers, with a as savings by smokers themselves and estimate will be dissuaded from specific net cost of $3,757 per female $401.7 million by nonsmokers. With a smoking in 2013, they make up the vast 24-year-old smoker and $2,617 per male 7-percent discount rate, the total majority of smokers newly dissuaded in 24-year-old smoker (in 2000 dollars and decrease in expenditure becomes $491.3 years 2014 to 2031 because it is young with a 3-percent discount rate). Of the million, with $261.2 million of those people and a few immigrants who will female smoker’s net cost, $2,031 will be savings accruing to smokers and $230.1 be exposed to graphic warning labels for borne by the smoker herself and the million to nonsmokers. Further details the first time in those later years. remainder by nonsmokers in the form of about the nonsmoker portion of Overall, then, our morbidity results increases in private insurance premiums expenditures appear in the include effects for 98,355, or 33.8 or taxes used to fund government health Distributional Effects portion of this percent, of our estimated 291,103 programs such as Medicaid. Of the male analysis. (undiscounted) smoking dissuasions. smoker’s net cost, $1,372 will be borne In the absence of the rule, some Second, the reduction in health risk by the smoker himself and the portion of smoking-related medical experienced by smokers who quit at remainder by nonsmokers. We adjust expenditures accrues to health service ages 25 and above will be smaller than these cost estimates for inflation using providers as economic rent (also known

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as producer surplus 14). Any reduction must be considered in light of the case, the total value of the subsidy, or of this portion will not contribute to the optimal internality tax estimation 100 percent of the values in table 23, social benefit of the rule but will instead approach and the related need to would need to be added to our net be a transfer of resources from health estimate gross internal benefits and benefits estimate. Because morbidity service providers to consumers, public costs of dissuaded smoking. The and mortality are the primary but not and private insurers, and others. A mixture of positive and negative values the only ways in which smoking affects further complication in the analysis of in table 23 shows that societal transfers Social Security, income tax, pension, the market for health is generated can take the form of both subsidies and and life insurance payments and because nonsmokers’ payments take the additional costs of smoking; when receipts, we do not know the extent to form of a subsidy for smoking-related summed together, the positive and which our morbidity and mortality medical services and thus some portion negative effects in table 23 show a net willingness-to-pay measures capture of their expenditure in the absence of smoking subsidy, which individuals smokers’ experience of these transfers. the rule is greater than smokers’ own relinquish when they avoid initiating or We will assume that 50 percent of the willingness-to-pay for those medical quit smoking. midpoint values in table 23 are included services. Both for this reason and due to There is a difficulty in quantifying the the existence of economic rent, the effect of the types of transfers appearing in our morbidity and mortality avoidance of at least some portion of in table 23 of this document on internal estimates; with this assumption, our nonsmokers’ smoking-related spending benefits. Smokers’ experience of these estimated net benefits will change in will transfer value from one portion of transfers may already be included in the two opposing directions: They will society to another but not contribute to section XI.D.2.b.ii and XI.D.2.b.iii of this increase by 100 percent of the midpoint an overall social benefit of the rule. We document estimates of gross health values in table 23 (representing the do not know the size of this portion benefits because the willingness-to-pay reduced subsidy payment from the relative to nonsmokers’ overall rule- measure on which we base our general public), but will decrease by an induced expenditure change, so we morbidity and mortality calculations amount equal to 50 percent of the table assume that 50 percent of nonsmokers’ includes all the effects a person will 23 midpoint values times the net-to- smoking-related spending accrues as a likely experience as a result of gross benefits ratio (representing the net social benefit of the rule. This improving his or her health and effects on dissuaded smokers that are produces an overall estimate of rule- extending his or her life. These effects not included in the morbidity and induced reductions in medical include increased opportunities to mortality estimates). collect Social Security and defined expenditures of $659.0 million, Summing our estimates of rule- benefit pension payments, a decreased calculated with a 3-percent discount induced life-year extensions, health rate, or $376.3 million, calculated with chance of leaving survivors enough life status improvements, medical cost a 7-percent discount rate. insurance to make up for the amount v. Other financial effects of smoking paid in premiums, and increases in reductions, and financial effects, we cessation. In section XI.F.6 of this pension and income tax payments (due find that the present value of health- document, we will discuss in detail the to working longer and receiving higher related and financial benefits accruing effects of the rule on Social Security, wages in compensation for higher to dissuaded smokers totals $9.29 to income taxes, private pensions, and life productivity). If the results in section $27.50 billion (with a 3-percent insurance. Summaries of these effects XI.D.2.b.ii and XI.D.2.b.iii of this discount rate) or $2.10 to $6.01 billion will appear in table 23 of this document. document already reflect these (with a 7-percent discount rate). As For the most part, we will characterize phenomena, what is missing from our shown in table 7 of this document, the the values appearing in table 23 as analysis is not the intrapersonal effect present value of financial benefits transfers, having equal and offsetting associated with smokers’ experience of accruing to the general public totals effects on various members of society. table 23 transfers but the direct benefit $733.1 million (with a 3-percent There are, however, some additional to the general public of no longer discount rate) or $330.3 million (with a consequences of these transfers that providing a net smoking subsidy; in this 7-percent discount rate).

vi. Summary of benefits accruing to document presents benefits estimates ratios, ranging, as discussed in dissuaded smokers. Table 8 of this that reflect a variety of net-to-gross Technical Appendix X5, from the 7

14 The difference between what a supplier is paid for a good or service and the marginal cost of supplying that good or service.

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percent derived from the work of Gruber benefits to dissuaded smokers, we information; instead, our results are and Ko¨szegi to the 90 percent suggested follow the recommendation of OMB qualitatively consistent with policy in a public comment. Also presented are Circular A–4 and use the midpoints for implications of economic models in the net internal benefits results derived our primary calculations in the which consumers are characterized by from Warner et al.’s work on the value remainder of this analysis. The resulting hyperbolic discounting, incorrect to smokers of cessation programs. For midpoints range from $4.37 to $12.56 forecasting, temptation utility or self- each discount rate and VSLY, we also billion (with a 3-percent discount rate) control problems (in addition to Gruber report the midpoint between the lower or $1.02 to $2.86 billion (with a 7- and Ko¨szegi (Ref. 104), see Bernheim and upper bound benefits estimates, percent discount rate). We emphasize and Rangel (Ref. 105) and Gul and where the upper bound is yielded by the that all the net benefits appearing in Pesendorfer (Ref. 110)) and with Gruber 90 percent net-to-gross benefits ratio table 8 are intrapersonal and thus could and Mullainathan’s (Ref. 182) and the lower bound by the 7-percent not be positive if all tobacco consumers examination of the effect of cigarette ratio in some cases and by the cessation were time-consistent, fully rational, self- excise taxes on the happiness of value approach in others. Given the controlled, able to resist temptation, and individuals with a high propensity to great variation in estimates of net in possession of perfect and complete smoke.

3. Reduced Fire Costs appropriate discounted lifetime present-day annual total as a result of Each year, fires started by lighted cigarette consumption (in packs) per the final rule. tobacco products kill and injure people smoker. FDA calculates average The rule-induced percentage and destroy structures and other consumption for 18- to 23-year-olds reduction in fires may not equal the percentage reduction in cigarette property. In the United States in 2007, using the May 2006, August 2006, and consumption, however, because all 50 civilian deaths caused by smoking- January 2007 Tobacco Use Supplements States have passed legislation that related fires totaled 720, with direct to the Current Population Survey (Ref. requires cigarettes to be self- property damage of $530 million (Ref. 142). Sloan et al. (Ref. 116) report extinguishing or fire-safe (Ref. 144). 141). A reduction in the number of lifetime discounted consumption for FDA acknowledges some uncertainty in smokers, and the coinciding number of typical 24-year-old smokers. Comparing the effectiveness rate of fire-safe cigarettes smoked, will reduce the against total consumption in 2006 (the cigarettes; 15 for this analysis, we number of future fires. most recent year for which the FTC (Ref. FDA estimates the rule-induced 143) reports cigarette sales), we find that 15 One of the first States to enact these laws, New decrease in cigarettes smoked by discounted lifetime cigarette York, requires cigarettes to self-extinguish 75 multiplying together the percentage consumption will decrease by an percent of the time (Ref. 145). Data from New York change in smoking whose calculation amount equivalent to 3.9 percent (using show a reduction in smoking-caused fires of about was described in section XI.D.1 of this 10.6 percent from the average of the 4 years (2000 a 3-percent discount rate) or 2.1 percent to 2003) prior to passage of the fire-safe cigarette document, the projected population in a (using a 7-percent discount rate) of a law to the first 2 years (2006 to 2007) after given year (Ref. 130) and age- implementation was complete (Ref. 146).

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estimate that 10.6 percent of apparently total rule-induced fire-cost savings of 4. Summary of Benefits rule-induced future fire reductions $106.0 to $262.5 million (at a 3-percent would have been avoided even without discount rate) or $34.1 to $76.5 million The discussion above demonstrates this final rule due to fire-safe cigarette (at a 7-percent discount rate); of these the considerable magnitude of the design. totals, $12.9 (7-percent discount rate) or economic benefits available from The National Fire Protection $27.7 million (3-percent discount rate) smoking reduction efforts. As shown in Association (Ref. 147) reports the consists of averted property damage, table 9a of this document, our midpoint percentages of fire fatalities by age with the remainder being the value of benefits estimates range from $5.21 to category; along with the CDC’s estimate life-years saved. These estimated $13.55 billion (with a 3-percent of average American life expectancy savings may significantly underestimate discount rate) or $1.38 to $3.27 billion (Ref. 136), these data allow FDA to the final rule’s fire-related benefits (with a 7-percent discount rate). calculate that the average number of because they exclude noncivilian Estimates are presented as annualized life-years lost by fire victims is mortality and the value of reduction in values in table 9b of this document, approximately 37.3; we project that total fire-caused nonfatal injuries. There will, reported over time in Appendix X3, and discounted life-years saved as a result of however, be some double counting subjected to Uncertainty Analysis in the rule will be 317.4 (at a 7-percent between the estimated fire-related Technical Appendix X6. Nonquantified discount rate) or 1,198.5 (at a 3-percent mortality benefits and the mortality benefits include reductions in discount rate). Using—as in sections benefits estimated in section XI.D.2.b.ii nonsmoker morbidity and mortality XI.D.2.b.ii and XI.D.2.b.iii of this of this document to the extent that it is associated with passive smoking and document—VSLY ranging from smokers themselves who are killed in $106,308 to $318,923, FDA estimates cigarette-caused fires. mothers smoking during pregnancy.

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E. Costs sectors will experience lost sales and retailers. We use detailed data from the Implementation of this final rule, and employment, but these revenue transfers 2002 Economic Census report on the statutory requirements directly will be offset by gains to other sectors, product line sales for establishments linked to it, will create new burdens for as discussed in the ‘‘Distributional with payroll to estimate the percentage cigarette manufacturers. In particular, Effects’’ section of this document. of various types of retail establishments manufacturers will incur the upfront 1. Number of Affected Entities that sell tobacco products. Searching by costs associated with a major labeling the Economic Census product line change.16 There will be additional Labeling and advertising requirements 20150 (cigars, cigarettes, tobacco, & ongoing costs associated with equal and will affect domestic cigarette smokers’ accessories), we find random display of the warnings manufacturers and importers of foreign- accommodation and food service required in this rule, as mandated by the made cigarettes. Statistics of U.S. establishments (NAICS 72) and retail Tobacco Control Act. Cigarette Businesses data show that there were 24 trade establishments (NAICS 44–45) that manufacturers and retailers will be cigarette manufacturing firms in the report tobacco sales (Refs. 149 and 150). responsible for the removal of United States in 2007 (Ref. 148). An Although some establishments in other noncompliant point-of-sale advertising. undetermined number of importers will industries may have unreported sales of Consumers are likely to ultimately bear also be affected. tobacco products, the product line sales a share of these costs in the form of Noncompliant point-of-sale data provide a reasonable basis to increased prices. In addition, the advertising will be removed by determine which establishments will be tobacco industry and possibly other manufacturers (or importers) and affected by the rule.

16 All of the upfront costs of this rule are assumed undiscounted calculations of these one-time costs. costs are discounted 1 year back to the present to occur in the first period of the time horizon of For summary tables requiring a present value, these (2011). this rule (2012). The cost tables present raw

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Because the 2007 Census data on is unchanged (since 2002) within each establishments in 2007 as for product line sales for retail category. Likewise, we lack 2007 Census establishments with payroll in the 2002 establishments with employees are not data on product line sales for Census. As shown in table 11 of this yet available, we update the number of nonemployer establishments. Without document, we estimate that about various types of retail establishments additional information, we assume that, 249,000 retail establishments with using 2007 Statistics of U.S. Businesses within a NAICS category, the share of payroll and 126,000 nonemployer data but assume the share of establishments selling tobacco products establishments sell tobacco products. establishments selling tobacco products will be the same for nonemployer

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2. Costs of Changing Cigarette Labels (incurred on a per-formulation basis). coordinated with previously scheduled, We have updated our analysis of the Because the model has a greater focus nonregulatory labeling changes. cost of changing cigarette labels based on analytic testing (e.g., measuring fat Coordination of a regulatory change on the availability of improved grams in a candy bar) than on market with a nonregulatory change reduces the estimates generated by the new FDA testing (which is the aspect of testing incremental burden of the regulatory labeling cost model. Unless stated applicable to cigarettes), we perform change. otherwise, our estimates in this analysis several modifications to the model’s As discussed in the responses to come from the new model. testing cost estimation. First, we comments, FDA follows its previous The front and back of every cigarette calculate costs on a per-brand, rather labeling cost model (Ref. 152) in package must be redesigned to than per-formulation, basis and, second, assuming 10-percent rush charges under incorporate graphic warnings that will we restrict the calculation of market a 15-month compliance period. Using occupy the entire top half, and the testing costs to the largest firms. The the labeling model cost estimates for current warning will be eliminated. This large cigarette manufacturers can uncoordinated changes and is classified by the labeling model as a plausibly be expected to conduct incorporating 10-percent rush charges, major change. (Any change that affects quantitative studies and focus group we estimate that labor costs for label more than one color or changes the testing for each of their brands to gauge design, including administrative labor layout enough to require a redesign is the effect of the new graphic warnings costs as well as graphic design and major.) In addition, the requirement to and to study how they might best be prepress labor costs, are $4,147 to incorporate nine different warnings will able to mitigate their effects. By $10,890. Materials costs are estimated to increase costs beyond what the labeling contrast, small manufacturers with be $6,644 to $10,934; included in this model estimates. FDA accounted for the lower sales revenues are highly unlikely total are both prepress materials and additional warnings by first calculating to conduct expensive market testing in printing plate costs.17 Recordkeeping the standard cost of a major change for response to the new requirements. costs are estimated to be $55 to $99. cigarette labels and then inflating Further details of our estimation Summing labor, materials, and specific cost components expected to approach will be discussed in section recordkeeping costs yields a per-UPC increase as a direct result of the XI.E.4 of this document. label design cost of $10,846 to $21,923. requirement for nine warnings. The labeling model estimates that a The model estimates that for The FDA labeling cost model total of 4,312 cigarette UPCs (3,789 coordinated labeling changes, there is a incorporates three potential cost branded and 523 private label) will be per-UPC cost of $340 to $840. This cost components of a labeling change: Label affected by this rule. However, it is is nonzero because there will still be design costs (incurred on a per-UPC estimated that label changes for 335 basis), inventory costs (incurred on a UPCs (8 percent of branded and 6 17 Rotogravure, the most expensive printing per-unit basis), and testing costs percent of private label) can be method, is used for cigarette package labels.

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some administrative labor and end of the compliance period and thus inventory-replacement cost of this recordkeeping associated with have to print new labels instead of using labeling change would then be $21,000 coordinating a regulatory change with a that inventory. (There is also a small to $30,000. Table 12 of this document previously scheduled, nonregulatory cost associated with disposal.) The summarizes the total cost of a standard change. Total label design costs of this labeling model estimates that 767,016 major labeling change (one warning per change are thus estimated to be $43 to labels will be discarded at the end of the UPC), which is estimated to be $43 to $87 million. 15-month compliance period, each $88 million. Manufacturers incur costs if they having a cost of $0.028 to $0.039. The discard unused label inventory at the

We expect materials costs for printing incremental materials cost of a document shows the total costs of the plates and prepress activities to be coordinated label change will be eight cigarette labeling change, making the approximately nine times as large as times the uncoordinated materials costs, adjustment for the nine-warning previously calculated for uncoordinated because eight extra printing plates will requirement. The labeling cost range UPCs because of the requirement for be needed. We assume that this increases to $273 million to $465 nine separate warnings. Each UPC will adjustment accounts for all the one-time million. require nine printing plates, one for costs that arise from the requirement to each warning label. Additionally, the use nine warnings.18 Table 13 of this

18 Some of the subcomponents of other cost between those cost categories and the number of paired with all nine labels. Likewise, the amount categories might increase due to the nine-warning warnings. For example, the part of the label that is of unused inventory discarded is unaffected by the requirement, but there is far less reason to believe under the manufacturer’s control only has to be number of warnings used under the new there will be a direct, proportional relationship designed once because the same design will be requirements.

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The cost of changing cigarette labels warning images required by this rule. the (non-rush) administrative labor cost is largely driven by materials costs. The Although the initial design and of an uncoordinated labeling change, distribution for the estimate of materials implementation of a system for equal and the yearly recordkeeping cost will costs is extremely skewed to the right, and random display will be part of the be equal to 50 percent of the (non-rush) as evidenced by the fact that the low upfront label change, continued recordkeeping cost of an uncoordinated and medium estimate are much closer operation of such a system in labeling change. As shown in table 14 than the medium and high estimates. subsequent years will have incremental of this document, FDA estimates that, We report the 90th percentile range but ongoing administrative and under these assumptions, ongoing note that the high value appears to be recordkeeping costs. Such a system will annual administrative and driven by a few extremely high values. be more burdensome than the current recordkeeping costs equal $375,000 to 3. Ongoing Costs of Equal and Random system of quarterly rotation of four $876,000. Display warnings. FDA assumes that the The Tobacco Control Act calls for ongoing yearly administrative labor cost equal and random display of the graphic per UPC will be equal to 10 percent of

4. Market Testing Costs Associated With (Refs. 153 through 158). If we assume study is estimated to range from $14,000 Changing Cigarette Package Labels (as in the labeling model) that 8 percent to $105,000 per brand. Assuming both As stated previously, FDA expects of changes for these brands are types of testing are conducted for 69 that only the large manufacturers will coordinated, then changes for the brands yields a total cost estimate conduct market tests for their brands. remaining 69 brands are not ranging from $1.5 to $8.2 million with Using several State directories of coordinated. Including rush charges, the a medium estimate of $2.1 million, as certified tobacco products, FDA cost of focus group testing is estimated shown in table 15 of this document. We estimates that 75 brands are marketed to range from $8,000 to $14,000 per assume that the requirement to use nine by the 4 largest domestic manufacturers brand, and the cost of a quantitative

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different color graphic-text pairs does not affect these costs.

5. Advertising Restrictions: Removal of used average removal costs for seven point-of-sale advertising from physical Noncompliant Point-of-Sale Advertising types of retail establishments, calculated retail locations, we do not include using in-store surveys conducted by nonstore establishments. Table 17 of The principal effect of the restrictions A.T. Kearney, Inc. (61 FR 44396 at this document shows that, in current on advertising in the rule stem from the 44580). We retain our assumptions from dollars, one-time per-establishment requirement that retailers and 1996 about the level of effort required to costs range from about $12 for ‘‘other manufacturers of cigarettes remove any remove point-of-sale advertising. We establishments’’ to about $198 for point-of-sale advertising for cigarettes acknowledge, however, that this convenience stores. To estimate the total that fails to conform to the approach may overstate or understate costs to comply with the restriction on requirements. In this analysis, we the costs for a particular action or type point-of-sale advertising, we apply the estimate the social resource costs for the of business. removal. In the analysis of FDA’s 1996 Table 16 of this document regroups updated per-establishment costs from final tobacco rule, we based much of our the information from table 11 of this table 17 to affected establishments. As estimate of the cost of removing document according to the categories shown in table 18 of this document, the noncompliant point-of-sale advertising studied by A.T. Kearney. Because our one-time costs to remove point-of-sale on a report from the Barents Group that analysis considers only the removal of materials will total $45.4 million.

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6. Government Administration and An additional cost of the final rule, and annualized value of costs. The Enforcement Costs borne by government but not necessarily tables in Technical Appendix X4 show FDA, arises due to the required the undiscounted stream of costs. The FDA’s estimated internal costs for reference to the cessation resource. The range of total costs presented in table 20 administering and enforcing this rule requires the final graphic warning of this document is an approximate 90 regulation are uncertain. As a best labels to refer to an already-existing percent confidence interval and, as estimate, however, FDA projects that 25 cessation resource. Therefore, only costs such, corresponds to the uncertainty full-time equivalent employees (FTEs) associated with additional traffic to that range of benefits presented in table 51 will be needed to implement the rule. resource are attributable to this final of this document. The distributions of Fully loaded employee costs vary with rule. FDA has not quantified these costs. costs and benefits, however, are not the type of employee (e.g., field 7. Summary of Costs correlated; in other words, it may be the inspectors versus administrative), but an Table 19 of this document case that the actual effects of the rule average of $247,049 per FTE places the fall in the high end of the cost range and dollar cost at approximately $6.2 summarizes the cost estimates from the preceding sections and table 20 of this the low end of the benefits range, or vice million per year. document displays the present value versa.

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F. Cost-Effectiveness Analysis and health improvement benefits discounted smoking preventions or estimates calculated in section XI.D.2.b cessations. Similarly, we find that We measure the effectiveness of the of this document); this yields overall 18,534 to 86,326 discounted QALYs will final rule as the sum of saved life-years costs of $1.46 to $3.70 billion (using a be saved (this includes both fractional and QALYs. In order to assess the cost- 7-percent discount rate) or $5.33 to life-years associated with reduced effectiveness of the rule, we must adjust $15.55 billion (using a 3-percent morbidity and full life-years associated the costs to account for effects that are discount rate). In order to focus on the with reduced premature mortality—both not captured by life-years or QALYs. As costs associated with extensions of for smokers themselves and for others shown in detail in the previous section, quality-adjusted life (see Ref. 103 at pp. caught in the path of cigarette-related we calculated the first 20 years’ costs 11–12), we then subtract both medical fires). This yields a cost per smoking attributable to the rule and found cost reductions and the value of prevention of $4,530 to $59,287, and a present values of $367.6 to $558.4 property savings due to reductions in million (using a 7-percent discount rate) accidental fires and arrive at a net cost cost per QALY saved of $50,746 to or $407.3 to $607.4 million (using a 3- of $0.94 to $3.19 billion (using a 7- $172,082. Braithwaite et al. (Ref. 159) percent discount rate). We add to each percent discount rate) or $4.38 to $14.59 find that preferences in the United total the estimated monetary value of billion (using a 3-percent discount rate). States are such that the threshold for lost consumer surplus (as discussed in Discounting over the same 20-year cost-effective interventions is detail in Technical Appendix X5, this time period, we calculate that this rule somewhere in the range of $109,000 to was implicitly netted out of life-years will lead to 208,535 to 246,137 $297,000 per QALY saved.

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G. Distributional Effects their acreage from growing tobacco to conduct less advertising. On the other This final rule will lead to losses to producing other agricultural products. hand, advertising industry revenue may increase due to cigarette sellers’ need to some segments of U.S. society that will 2. National and Regional Employment redesign advertisements to most likely be offset by equal gains to Patterns some other segments of society; as such, accommodate new warning labels and Several studies estimate the to devise new promotional strategies. In these effects do not constitute net social contribution of tobacco to the U.S. costs or benefits and have not yet been either case, few net social costs or economy or, alternatively, the losses to benefits will be generated. Moreover, discussed in detail in this Analysis of the U.S. economy that will follow a the effect on advertising revenue will Impacts. In general, sectors affiliated decline in tobacco-related consumption. likely be relatively small because with tobacco and tobacco products will Economists have shown both spending on cigarette advertising has lose sales revenues as a result of this theoretically and empirically that, for declined substantially in recent years final rule. Simultaneously, nontobacco- the nation as a whole, employment and is now quite small compared with related industries will gain sales, gains from spending on other products the 1980s and 1990s (Ref. 143). By 2006, because dollars not spent for tobacco will offset any employment losses from expenditures on magazine advertising products will be spent on other reduced spending on tobacco products had fallen to about $50 million and commodities. (Ref. 162). The major tobacco-growing outdoor advertising to under $1 million. 1. Tobacco Manufacturers, Distributors, states, however, will experience some Most of the remaining affected and Growers adverse economic effects. An economic advertising expenditures were point-of- simulation of the regional impacts of FDA estimates that implementation of sale promotions, which totaled $240 spending on tobacco products carried million (Ref. 143). the regulation may reduce the annual out in 1994 found that after 8 years, a cigarette consumption of U.S. smokers 2-percent per year fall in tobacco 5. Excise Tax Revenues by 30.8 million packs (in 2013) to 40.5 consumption (which substantially In 2009, Federal tobacco tax revenues million packs (in 2031). Meanwhile, the exceeds the FDA forecast for the effects totaled $16.3 billion, while State and FTC (Ref. 143) reports that, in 2006, 17.5 of this final rule) would cause the loss local tobacco tax revenues totaled $16.5 billion cigarette packs were of 36,600 jobs for the Southeast Tobacco billion (Ref. 163). This rule will manufactured and distributed to region of the United States (0.2 percent decrease government tobacco tax consumers. These numbers imply that of regional employment), whereas the revenues as fewer Americans consume tobacco manufacturer revenues will be nontobacco regions of the United States cigarettes. Sales tax revenues generated 0.176 percent lower in the rule’s first would gain 56,300 jobs (Ref. 122). That through tobacco sales will also fall as a year, and 0.231 percent lower in 2031, study, if carried out today, would find result of the rule, but those changes will than they were in 2006. The U.S. Census a much smaller net effect because total be much smaller than the changes in Bureau (Ref. 160) reports that tobacco employment in tobacco-related excise tax collections and have not been manufacturers’ revenues totaled $41.6 industries has fallen. Overall, FDA finds quantified by FDA. billion in 2006; hence, the rule-induced that the income and employment effects FDA estimates this change in excise decrease in annual tobacco sales will associated with the estimated reduction tax revenues by multiplying together the range from approximately $73.1 to $96.2 in tobacco consumption will be small. percentage change in smoking rate, million. These estimates would rise whose calculation was described in somewhat higher if we were accounting 3. Retail Sector section XI.D.1 of this document; the for the decrease in price that As will tobacco growers, distributors, projected population in a given year accompanies the decrease in demand for and manufacturers, tobacco retailers (Ref. 130); age-appropriate discounted a good (in this case, cigarettes). will be affected by any decrease in lifetime cigarette consumption (in Experimental evidence from Mexico cigarette sales. Retailers will, however, packs) per smoker; and current Federal (Ref. 101) indicates that graphic warning be in a position to shift shelf space and and average State tax rates (Refs. 164 labels may decrease smokers’ promotional activities to nontobacco and 165). FDA calculates average willingness-to-pay for cigarettes by 17 products, in order to take advantage of consumption for 18- to 23-year-olds percent; however, without supply the increase in demand for other using the May 2006, August 2006, and elasticity data, we cannot determine products that will be expected to January 2007 Tobacco Use Supplements how much this decline in willingness- accompany the decrease in spending on to the Current Population Survey (Ref. to-pay will change cigarettes’ market cigarettes. It is possible that some 142). Sloan et al. (Ref. 116) report price. retailers who rely heavily on cigarette lifetime discounted consumption for We estimate that the tobacco sales may not be able to fully offset their typical 24-year-old smokers. manufacturing, warehousing, and reduction in cigarette sales with sales of FDA estimates that average direct wholesale trade sectors employ about other products. Other retailers would annual rule-induced decreases in excise 74,000 full-time workers (Ref. 148). then experience some of the gain in tax collections will be approximately Under the assumption of constant sales associated with an increase in $33.4 million for State governments and production-to-employment ratio, we demand for other products. This would $25.7 million for the Federal project that a 0.176 to 0.231 percent be a distributional effect within the government. Approximately 25 percent reduction in sales will result in the retail sector. of this reduction may be offset by displacement of 130 to 171 jobs among increased sales of other taxable goods manufacturers, warehousers, and 4. Advertising Industry and services (Ref. 166); thus, the annual wholesalers. The overall impact of the rule on the reductions in tax collections will be Effects of the rule will also be advertising industry is uncertain. $25.1 million for State governments and observed in the agricultural sector. Advertiser revenue may decrease $19.3 million for the Federal According to USDA’s 2007 Census of because advertisements with graphic government. Assuming that excise taxes Agriculture (Ref. 161), there are 16,234 warning labels are less desirable from a rise, on average, at the rate of inflation tobacco farms. Upon implementation of cigarette seller’s standpoint and thus allows us to sum these values over the the rule, these farms may shift some of tobacco manufacturers will choose to time horizon of our analysis, yielding an

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overall revenue loss to State inflation forecast of 2.33 percent per net costs are $3,757 per female 24-year- governments of $454.9 million (present year. At this rate of inflation, the overall old smoker and $2,617 per male 24- value with a 7-percent discount rate) to rule-induced tax revenue loss to State year-old smoker. Smokers bear a portion $977.5 million (present value with a 3- governments will be $327.8 to $590.0 of these net costs themselves, but a percent discount rate) and to the Federal million and to the Federal government portion equaling $1,726 per female government of $348.1 million (present will be $250.6 to $451.9 million. FDA smoker or $1,245 per male smoker is value with a 7-percent discount rate) to emphasizes that these estimates would borne by nonsmokers through increased $749.8 million (present value with a 3- be altered, possibly a great deal, either private insurance premiums or taxes percent discount rate). by future changes in tax rates or used to fund government health care inaccuracy in the inflation forecast. Because we cannot know if nominal programs; hence, a reduction in the U.S. We note that, leaving aside potential smoking population will transfer value cigarette excise taxes actually will deadweight loss, there are two principal increase at the rate of inflation, we also from smokers (who receive medical effects of tax reductions: Gains to former services paid partially by the general calculate these discounted present payers and losses to former recipients. public) to nonsmokers. If nonsmokers’ values for the case in which tax rates Because these transfers exactly offset payment portions are adjusted for remain at their current nominal levels. each other, there is no net social cost or inflation and distributed over ages 24 to In this case, the real tax rate will fall at benefit associated with the reduction in the rate of inflation, which we forecast excise tax collections induced by the 100 as described in section XI.D.2.b.iv using the difference between interest rule. of this document (‘‘Medical Services’’), rates for standard and inflation- given FDA’s projected 20-year protected long-term Treasury bills. The 6. Government-Funded Medical reductions in smoking prevalence, this U.S. Department of the Treasury (Ref. Services, Insurance Premiums, and transfer totals $401.7 million. With a 7- 167) reports that, as of February 11, Social Security percent discount rate, the total becomes 2011, the composite rate for long-term Sloan et al. (Ref. 116) estimate that $230.1 million. Sloan et al. indicate that standard bills was 4.33 percent, while smokers use more medical services over this reduction will be distributed the composite rate for long-term their life cycles than do comparable unequally across Medicare, Medicaid, inflation-protected bills was 2.00 nonsmokers; in 2000 dollars and and other insurance types. Details percent; the difference yields an discounted at a 3-percent rate, specific appear in table 22 of this document.

Sloan et al. (Ref. 116, at p. 255) the individuals who are dissuaded from smokers aged 25 and above as they are estimate the effect of smoking, per male smoking by the regulation. A transfer in for 24-year-olds. In converting Sloan et and female smoker, on net Social the opposite direction—from al.’s present values, calculated with a 3- Security, private pension, and life individuals dissuaded from smoking by percent discount rate, to present values insurance outlays, as well as on income the regulation to the general public— calculated with a 7-percent discount tax payments. In the cases of Social will occur in the realms of life insurance rate, further assumptions are necessary. Security and private pension outlays, programs and income taxes. We calculate the ratios of 7-percent smoking-related premature mortality Because Sloan et al. only report present values to 3-percent present causes smokers to collect less from the effects for 24-year-olds, we can only values for all gross benefits categories programs than they contribute during directly calculate these transfer effects (life-years, health status, medical cost their lifetimes. Therefore, any rule- for cohorts who are no older than 24 reductions, and fire loss reductions) and induced reduction in the U.S. smoking during the period from 2012 to 2031. use the lowest and highest ratios for the population will shift value from The sum of these effects appears in the lower and upper bounds in table 23. members of the general public who pay lower bound columns of table 23 of this Finally, we note that we update Sloan Social Security taxes and who document. For the upper bounds, we et al.’s estimates using the most recent contribute to private pension plans to assume that effects are the same for annual GDP deflator (Ref. 132).

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H. International Effects I. Regulatory Alternatives label design and market testing costs are Of the $87.9 billion worth of tobacco We compare the rule to two eliminated, and discarded inventory products consumed in the United States hypothetical alternatives: An otherwise costs are eliminated. in 2009 (Ref. 168), only $156 million identical rule with a 24-month Table 24 of this document shows that consisted of imported cigarettes, with compliance period and an otherwise extending the compliance period to 24 another $897 million imported as identical rule with a 6-month months would reduce the upfront label tobacco in a less-processed state (Refs. compliance period. Even though we change cost by $30 to $53 million, to a 169 and 170). As in the United States, estimate costs and benefits for these total of $242 to $411 million. Table 25 foreign manufacturers, distributors, and alternatives, they do not provide viable of this document shows that market growers of tobacco and tobacco products regulatory options, as they are testing costs would be reduced by $0.3 will lose revenue as a result of the rule, inconsistent with FDA’s statutory to $1.8 million to a total of $1.2 to $6.4 though their loss will be a small fraction mandate. We also describe alternatives million.19 Extending the compliance of the overall revenue loss. As associated with different graphical period to 24 months would also delay consumers who would have been warnings. smokers purchase other products, there all costs by about 9 months. We account could be a shift in patterns of 1. 24-Month Compliance Period for this by discounting the present value international trade, depending on where Extension of the compliance period to of costs an extra 9 months in the the preferred substitute products are 24 months reduces the one-time costs of summary of alternatives table at the end made. this rule through three avenues: The of this section. The rule does not apply to cigarettes number of UPCs that can be coordinated manufactured for export, whose value with a previously scheduled labeling totaled $417 million in 2009 (Ref. 169). change is increased, rush charges for the

19 The increase in the proportion of UPCs that can be coordinated is also expected to affect the number of brands that are market tested.

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Extending the compliance period to of this delay may be found by this document, FDA finds that a 24- 24 months would delay the accrual of discounting, at 3- and 7-percent month compliance period would health and fire reduction benefits by 9 discount rates, the previously calculated decrease the present value of benefits by months. An approximation of the effect total benefits. As shown in table 26 of between $65.4 and $294.6 million.

2. 6-Month Compliance Period assumption of 40 percent rush charges, solution. Therefore, with a 6-month rather than assuming 10-percent rush compliance period, the cost of discarded With a 6-month compliance period, charges as we did with a 15-month inventory is the same as under a 12- the labeling cost model assumes that compliance period. The labeling model month compliance period, but there is there is not enough time for any of the further assumes that 12 months is the an additional cost for applying labeling changes to be coordinated with shortest compliance period that can be appropriate stickers to cover the old previously scheduled changes. Also, met without resorting to covering up the package label design. FDA accepts the labeling model’s old labels with stickers as a temporary

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The model, based on current sales the compliance period to 6 months compliance period to 6 months would data, estimates the number of units sold would then increase label change costs move all costs up by about 9 months. annually to be about 8 billion. by $258 to $1,430 million to a total of We account for this by compounding Therefore, 4 billion units would be $531 to $1,895 million. It would also the present value of costs 9 months in relabeled with stickers. The per-unit increase the market testing costs by $0.6 the summary of alternatives table at the cost for the sticker and application is to $3 million to a total of $2 to $11 end of this section. between $0.045 and $0.323. Reducing million. Finally, shortening the

Reducing the compliance period to 6 of this change in timing may be found this document, FDA finds that a 6- months would hasten the accrual of by compounding, at 3- and 7-percent month compliance period would health and fire reduction benefits by 9 discount rates, the previously calculated increase benefits by between $68.8 and months. An approximation of the effect total benefits. As shown in table 29 of $301.2 million.

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3. Alternative Graphic Images warnings. We cannot assess the effect of 4. Summary of Regulatory Alternatives A legally available alternative to this additional images on the benefits of the Table 30 of this document rule would be to select a different set of rule but more images would increase summarizes the regulatory alternatives graphic images. Although we are unable costs. Although not all costs rise in related to the compliance period by to quantify the effects of different proportion to the number of graphic displaying ranges for the present values graphic images, we note that some images, the materials cost, which is the of the total benefits and total costs. images may have a larger impact on largest cost component, would rise in Estimated ranges for the cost ratios (per smoking rates than other images. proportion to the number of images. smoking prevention and per life-year Another alternative suggested would saved) of the rule and its regulatory be to use more than nine graphic images alternatives appear in table 31 of this to accompany the nine statutory document.

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J. Impact on Small Entities required under the Regulatory business size standard of $750,000 Flexibility Act. (Refs. 161 and 171). The Regulatory Flexibility Act Table 32 of this document shows the 1. Description and Number of Affected requires agencies to prepare a final breakdown of domestic cigarette Small Entities regulatory flexibility analysis if a final manufacturers by employment size. rule will have a significant effect on a The final rule will affect small entities Census data indicate that most cigarette substantial number of small entities. We in several industries, from tobacco manufacturing firms are small expect this rule to have a significant farming to the retail industry. Most of businesses, with only 4 of 24 firms effect on a substantial number of small the Nation’s 16,234 tobacco farms are employing more than 500 employees, entities. Consequently, this analysis, small; between 90.7 and 95.8 percent while the small business size standard together with other relevant sections of (between 14,732 and 15,555) of the established by the SBA for this industry this document, serves as the Final farms growing tobacco in 2007 had total is 1,000 employees, so 20 small cigarette Regulatory Flexibility Analysis, as farm sales under the U.S. Small manufacturers will be affected (Refs. Business Administration (SBA) small 148 and 171).

Statistics of U.S. Businesses data 92 percent of them will be affected size categories used by the U.S. Census. show that 1,067 of 1,159 tobacco small businesses. Table 33 of this document shows the wholesale trade firms (92 percent) Also likely to be affected by the 2002 Census size categories that most employ fewer than the 100-employee regulation are small retail and service closely match the SBA size standards. In threshold that constitutes a small entities that sell cigarettes. Retail all cases, the closest Census size business according to the SBA (Refs. establishments bear shared category is smaller than the SBA size 148 and 171). If the size distribution of responsibility with manufacturers for standard. As a consequence, any cigarette importers is similar to that of the cost of removing noncompliant estimate based on the Census size advertising. SBA size standards for the all tobacco wholesale trade firms, then categories may underestimate the retail trade and the accommodations number of affected small entities. and food services industries differ from

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The Census reports establishment counting the number of firms that fall the category of business, the percentage numbers for business by product line, below the Census size standard shown of small firms ranges from 41 percent for and establishment and firm size by type in table 33 of this document, including Discount Department, Warehouse Clubs of business, but provides no size data by only firms in NAICS categories with and Superstores to almost 100 percent type of business and product line. To tobacco product line sales. Next, we for Convenience Stores. estimate the number of affected entities calculate the percentage of small firms that SBA classifies as small, we begin by in each NAICS category. Depending on

Finally, we apply the percentages in establishments are similar whether or affected by the rule. This number table 34 of this document to our current not they sell tobacco products. In represents about 98 percent of the estimate of the number of affected addition, we classify all nonemployer estimated 361,000 establishments establishments with payroll (table 16 of establishments as small. In total, we selling tobacco products. this document). This approach estimate that about 355,000 small retail implicitly assumes that small and service establishments will be

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2. Description of the Potential Impacts through 158). Because the costs of label million and ongoing costs of $9,000 to of the Final Rule on Small Entities changes are roughly proportional to the $21,000 per firm. Table 36 of this number of UPCs, FDA then attributes 49 document compares these estimated a. Effect on manufacturers. In order to percent of the total label design and compliance costs to average annual estimate how much of the label change inventory costs to the four firms receipts in order to gauge the potential and rotation costs will be incurred by employing at least 500 people. FDA impact of labeling change requirements small domestic cigarette manufacturers, attributes an additional 3 percent of the on small cigarette manufacturing firms. FDA subtracts from the total costs those label change costs to foreign Because the number of UPCs is probably costs estimated to be incurred by large 20 manufacturers. These adjustments larger for larger firms, costs are likely domestic manufacturers and foreign leave 48 percent of costs, or $131 to greater for larger firms than for smaller manufacturers. Scanner data from AC $223 million in upfront costs and firms; if so, this method overstates the Nielsen indicate that approximately 49 $180,000 to $420,000 in ongoing costs, impact on the smallest firms and percent of UPCs can be readily to be incurred by the 20 small identified as belonging to a brand manufacturers. Assuming costs are understates the impact on the largest marketed by one of the four largest distributed equally among these firms firms (within the category of firms cigarette firms by volume (Refs. 153 implies one-time costs of $6.5 to $11.2 employing fewer than 500 people).

b. Effect on retailers. As shown in About 90 percent of tobacco product Convenience stores (with gasoline table 37 of this document, retail trade line sales occur at gasoline stations, stations and stand-alone convenience businesses account for almost all sales food and beverage stores, general stores) account for about half of all of tobacco products (Refs. 149 and 150). merchandise stores, or tobacco stores. tobacco product line sales.

20 In 2008, 9.9 billion out of 345.3 billion FDA assumes the same proportion holds for UPCs. These UPCs should not overlap with those individual cigarettes sold were imported (Ref. 123). produced by the four largest domestic producers.

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To illustrate the effects of the rule on illustrated in table 37 of this document, revenue for these stores, composing over a typical small retail store, we look at sales of tobacco products in these stores 12 percent of total sales (as shown in one-time costs for a convenience store account for about 50 percent of all table 38 of this document). and a convenience store with gasoline. tobacco sales. In addition, tobacco We select these businesses because, as products are an important part of overall

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For both types of convenience stores, entities is uncertain, this example retailers who experience it. FDA has not table 39 of this document shows that for suggests that the rule will be unlikely to quantified this additional potential the smallest firms with less than create a significant direct burden on effect, but believes that it is minor $250,000 in annual sales, the one-time small retail stores or service because the overall reduction in costs of the rule will equal less than 2 establishments. cigarette consumption is predicted to be percent of annual average sales of If individual small retailers are unable less than one half of a percent, the tobacco products. Furthermore, one- to fully offset reduced cigarette sales demand for other goods is expected to time costs total less than 0.1 percent of with increased sales of other items, their increase, and retailers can be expected annual average sales of tobacco products sales revenue may fall. Although this to shift shelf space to the other goods for for stores with $1 million or more in decline would not be a social cost (as which demand increases. average annual sales. Although the discussed in the distributional effects impact on other small retail and service section) it would be a cost to the

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3. Alternatives To Minimize the Burden and increase the number of UPCs for potential impact of this regulatory on Small Entities which the addition of graphic warning alternative on cigarette manufacturing labels could be coordinated with firms employing fewer than 500 people. a. Increase the compliance period to previously scheduled label changes. As a comparison with table 36 of this 24 months for small manufacturers or Under a 24-month compliance period, document shows, this option would all manufacturers. Allowing all the one-time label change costs would provide some relief, but the burden manufacturers, or only small fall by an average of $0.7 to $1.3 million would remain significant. It would also manufacturers, 24 months to comply per small firm. Table 40 of this delay the public health benefits of the with the label changes would eliminate document compares the reduced rule and be inconsistent with FDA’s overtime and rush charges, eliminate estimated compliance costs to average statutory mandate. costs for replacing discarded inventory, annual receipts in order to gauge the

b. Allow small manufacturers to use randomly selected warning and graphic The costs to small businesses of one warning per UPC. Allowing small image per UPC would reduce their implementing this option can be cigarette manufacturers to use only one upfront label change cost substantially. approximated by assuming that the 20

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smallest firms bear 48 percent of the $9,000 to $21,000 per firm would be document shows, this alternative would cost of a standard (one warning) eliminated. Table 41 of this document provide significant relief. However, it is cigarette label change. The average cost compares the reduced estimated inconsistent with FDA’s statutory per small manufacturer would be compliance costs to average annual mandate. Smokers who use only one reduced by $5.5 to $9 million per firm. receipts in order to gauge the potential specific product would not be exposed Additionally, there would be some impact of this regulatory alternative on to all the warnings, which would likely small cost at the beginning to ensure cigarette manufacturing firms hinder the effectiveness of this rule. random selection of the warnings, but employing fewer than 500 people. As a the ongoing annual rotation cost of comparison with table 36 of this

c. Exempt small manufacturers from inconsistent with the public health Reports/2007/Ending-the-Tobacco- the labeling change requirements. objective of the rule as well as FDA’s Problem-A–Blueprint-for-the- Exempting small manufacturers from statutory mandate. Nation.aspx. the label change requirements would 4. Centers for Disease Control and XII. Paperwork Reduction Act of 1995 Prevention, ‘‘Vital Signs: Current eliminate their label change costs and Cigarette Smoking Among Adults Aged > ongoing rotation costs (an average The required warning disclosures are 18 Years—United States, 2009,’’ reduction of $6.5 to $11.2 million in the ‘‘public disclosure of information Morbidity and Mortality Weekly Report, upfront costs and $9,000 to $21,000 in originally supplied by the Federal 59(35), 1135–40, Sept. 10, 2010, ongoing costs), thus providing government to the recipient for th[at] available at http://www.cdc.gov/mmwr/ maximum relief. The combined market purpose,’’ and are, therefore, not within preview/mmwrhtml/mm5935a3.htm. share of the four largest manufacturers the scope of the Paperwork Reduction 5. Centers for Disease Control and was 89.7 percent in 2008 (Ref. 123). The Act (see 5 CFR 1320.3(c)(2)). Prevention, ‘‘Youth Risk Behavior Surveillance—United States, 2009,’’ immediate impact of exempting small XIII. References Morbidity and Mortality Weekly Report manufacturers would therefore be to The following references have been 2010, 59 (No. SS–5); June 4, 2010, allow 10.3 percent of cigarettes to be available at http://www.cdc.gov/mmwr/ marketed without graphic warning placed on display in the Division of pdf/ss/ss5905.pdf. labels. This proportion would grow over Dockets Management (see ADDRESSES) 6. Centers for Disease Control and time, however, as some consumers and may be seen by interested persons Prevention, ‘‘Tobacco Use Among would be expected to switch to brands between 9 a.m. and 4 p.m. Monday Middle and High School Students— marketed without graphic warnings. through Friday. (FDA has verified Web United States, 2000–2009,’’ Morbidity site addresses, but FDA is not and Mortality Weekly Report, 59(33); This approach would be inconsistent 1063–68, Aug. 27, 2010, available at with both FDA’s statutory mandate and responsible for any subsequent changes to the Web sites after this document http://www.cdc.gov/mmwr/preview/ the public health objectives of this rule. mmwrhtml/mm5933a2.htm. publishes in the Federal Register.) d. Exempt small cigarette retailers 7. Substance Abuse and Mental Health from the point-of-sale advertising 1. Centers for Disease Control and Services Administration, ‘‘Results from requirements. Exempting small cigarette Prevention, ‘‘Smoking-Attributable the 2008 National Survey on Drug Use retailers from the point-of-sale Mortality, Years of Potential Life Lost, and Health: National Findings,’’ and Productivity Losses—United States, Rockville, MD: 2009, available at http:// advertising requirements would 2000–2004,’’ Morbidity and Mortality www.oas.samhsa.gov/nsduh/2k8nsduh/ eliminate their need to remove Weekly Report, 57(45); 1226–1228, Nov. 2k8Results.pdf. noncompliant advertising, reducing 14, 2008, available at http:// 8. Taioli, E., and Wynder, E.L., ‘‘Effect of the their direct costs to zero. However, table www.cdc.gov/mmwr/preview/ Age at Which Smoking Begins on 35 of this document shows that the mmwrhtml/mm5745a3.htm. Frequency of Smoking in Adulthood,’’ overwhelming majority of retail 2. U.S. Department of Health and Human The New England Journal of Medicine, establishments selling cigarettes are Services, ‘‘The Health Consequences of 325(13); 968–69, 1991. small. Although the few establishments Smoking,’’ A Report of the Surgeon 9. Chen, J., and Millar, W, ‘‘Age of smoking operated by large firms might be General; 2004, available at http:// initiation: implications for quitting,’’ www.surgeongeneral.gov/library/ Health Reports (Statistics Canada, expected to have higher volume, a smokingconsequences/index.html. Catalogue 82–003–XPB), 9(4); 39–46, significant proportion of consumers 3. Institute of Medicine of the National 1998. would continue to be exposed to Academies, ‘‘Ending the Tobacco 10. Breslau, N., and Peterson, E., ‘‘Smoking advertising lacking the new graphic Problem: A Blueprint for the Nation,’’ Cessation in Young Adults: Age at warnings. This situation would be 2007, available at http://www.iom.edu/ Initiation of Cigarette Smoking and Other

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EST2009–01), December 2009, available manufacture, package, or import Kingman Reef, or Johnston Island and at http://www.census.gov/popest/states/ cigarettes for sale or distribution within any place outside thereof; tables/NST–EST2009–01.xls (accessed the United States. (2) Commerce between points in any February 7, 2011). State, the District of Columbia, the 181. Weimer, D.L., Vining, A.R., and Thomas, (c) A cigarette retailer shall not be R.K., ‘‘Cost-Benefit Analysis Involving considered in violation of this part as it Commonwealth of Puerto Rico, Guam, Addictive Goods: Contingent Valuation applies to the display of health the U.S. Virgin Islands, American to Estimate Willingness-to-Pay for warnings on a cigarette package if the Samoa, Wake Island, Midway Islands, Smoking Cessation,’’ Health Economics, package: Kingman Reef, or Johnston Island, but 18; 181–202, 2009. (1) Contains a health warning; through any place outside thereof; or 182. Gruber, J.H. and Mullainathan, S., ‘‘Do (2) Is supplied to the retailer by a (3) Commerce wholly within the Cigarette Taxes Make Smokers Happier?’’ license- or permit-holding tobacco District of Columbia, Guam, the U.S. Advances in Economic Analysis & Virgin Islands, American Samoa, Wake Policy, 5(1); Article 4, 2005. product manufacturer, importer, or 183. Smith, V.K., Taylor, D.H., Jr., Sloan, distributor; and Island, Midway Island, Kingman Reef, F.A., et al., ‘‘Do Smokers Respond to (3) Is not altered by the retailer in a or Johnston Island. Health Shocks?,’’ The Review of way that is material to the requirements Distributor means any person who Economics and Statistics, 83(4); 675–87, of section 4(a) of the Federal Cigarette furthers the distribution of cigarettes at November 2001. Labeling and Advertising Act (15 U.S.C. any point from the original place of manufacture to the person who sells or List of Subjects in 21 CFR Part 1141 1333(a)) or this part, including by obscuring the warning, by reducing its distributes the product to individuals Advertising, Incorporation by size, by severing it in whole or in part, for personal consumption. Common reference, Labeling, Packaging and or by otherwise changing it in a material carriers are not considered distributors containers, Tobacco, and Smoking. way. for the purposes of this part. Therefore, under the Federal Cigarette (d) A cigarette retailer shall not be Front panel and rear panel mean the Labeling and Advertising Act, the two largest sides or surfaces of the Federal Food, Drug, and Cosmetic Act, considered in violation of this part as it applies to the display of health package. and under authority delegated to the Importer means any person who Commissioner of Food and Drugs, warnings in an advertisement for cigarettes if the advertisement is not imports any cigarette that is intended chapter I of title 21 of the Code of for sale or distribution to consumers in Federal Regulations is amended by created by or on behalf of the retailer and the retailer is not otherwise the United States. adding part 1141 to subchapter K to Manufacturer means any person, read as follows: responsible for the inclusion of the required warnings. This paragraph shall including any repacker or relabeler, who not relieve a retailer of liability if the manufactures, fabricates, assembles, PART 1141—CIGARETTE PACKAGE retailer displays, in a location open to processes, or labels a finished cigarette AND ADVERTISING WARNINGS the public, an advertisement that does product. Package means a pack, box, carton, or not contain a health warning or that container of any kind in which Subpart A—General Provisions contains a warning that has been altered cigarettes are offered for sale, sold, or Sec. by the retailer in a way that is material otherwise distributed to consumers. 1141.1 Scope. to the requirements of section 4(b) of the Person means an individual, 1141.3 Definitions. Federal Cigarette Labeling and partnership, corporation, or any other Subpart B—Cigarette Package and Advertising Act (15 U.S.C. 1333(b)), this business or legal entity. Advertising Warnings part, or section 4(c) of the Federal Required warning means the Cigarette Labeling and Advertising Act 1141.10 Required warnings. combination of one of the textual 1141.12 Incorporation by reference of (15 U.S.C. 1333(c)), including by warning statements and its required warnings. obscuring the warning, by reducing its accompanying color graphic, which are 1141.14 Misbranding of cigarettes. size, by severing it in whole or in part, set forth in ‘‘Cigarette Required or by otherwise changing it in a material Subpart C—Additional Disclosure Warnings,’’ which is incorporated by Requirements for Cigarette Packages and way. Advertising reference at § 1141.12. § 1141.3 Definitions. Retailer means any person who sells 1141.16 Disclosures regarding cessation. For the purposes of this part, cigarettes to individuals for personal Authority: 15 U.S.C. 1333; 21 U.S.C. 371, Cigarette means: consumption, or who operates a facility where vending machines or self-service 387c, 387f; Secs. 201 and 202, Pub. L. 111– (1) Any roll of tobacco wrapped in displays of cigarettes are permitted. 31, 123 Stat. 1776. paper or in any substance not United States, when used in a containing tobacco; and Subpart A—General Provisions geographical sense, includes the several (2) Any roll of tobacco wrapped in States, the District of Columbia, the § 1141.1 Scope. any substance containing tobacco Commonwealth of Puerto Rico, Guam, which, because of its appearance, the (a) This part sets forth the the U.S. Virgin Islands, American type of tobacco used in the filler, or its requirements for the display of health Samoa, Wake Island, Midway Islands, packaging and labeling, is likely to be warnings on cigarette packages and in Kingman Reef, and Johnston Island. The offered to, or purchased by, consumers advertisements for cigarettes. FDA may term ‘‘State’’ includes any political as a cigarette described in paragraph (1) require additional statements to be division of any State. displayed on packages and in of this definition. advertisements under the Federal Food, Commerce means: Subpart B—Cigarette Package and Drug, and Cosmetic Act or other (1) Commerce between any State, the Advertising Warnings authorities. District of Columbia, the (b) The requirements of this part do Commonwealth of Puerto Rico, Guam, § 1141.10 Required warnings. not apply to manufacturers or the U.S. Virgin Islands, American (a) Packages—(1) It shall be unlawful distributors of cigarettes that do not Samoa, Wake Island, Midway Islands, for any person to manufacture, package,

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sell, offer to sell, distribute, or import (4) For foreign-language warnings, § 1141.14 Misbranding of cigarettes. for sale or distribution within the except for Spanish-language warnings, (a) A cigarette shall be deemed to be United States any cigarettes the package each required warning shall be obtained misbranded under section 903(a)(1) of of which fails to bear, in accordance from the electronic images contained in the Federal Food, Drug, and Cosmetic with section 4 of the Federal Cigarette ‘‘Cigarette Required Warnings,’’ which Act if its package does not bear one of Labeling and Advertising Act (15 U.S.C. is incorporated by reference at the required warnings in accordance 1333) and this part, one of the required § 1141.12, and accurately reproduced as with section 4 of the Federal Cigarette warnings on the front and the rear specified in ‘‘Cigarette Required Labeling and Advertising Act (15 U.S.C. panels. Warnings,’’ including the insertion of a 1333) and this part. A cigarette shall be (2) The required warning shall be true and accurate translation of the deemed to be misbranded under section obtained from the electronic images textual warning. The inserted textual 903(a)(7)(A) of the Federal Food, Drug, contained in ‘‘Cigarette Required warning must comply with the and Cosmetic Act if its advertising does Warnings,’’ which is incorporated by requirements of section 4(b)(2) of the not bear one of the required warnings in reference at § 1141.12, and accurately Federal Cigarette Labeling and accordance with section 4 of the Federal reproduced as specified in ‘‘Cigarette Advertising Act (15 U.S.C. 1333(b)(2)). Cigarette Labeling and Advertising Act Required Warnings.’’ (15 U.S.C. 1333) and this part. (3) The required warning shall appear (5) The required warning shall occupy (b) A cigarette advertisement or directly on the package and shall be at least 20 percent of the area of each package will be deemed to include a clearly visible underneath the advertisement, and shall be placed in brief statement of relevant warnings for cellophane or other clear wrapping. accordance with the requirements in the (4) The required warning shall be the purposes of section 903(a)(8) of the Federal Cigarette Labeling and Federal Food, Drug, and Cosmetic Act if located in the upper portion of the front Advertising Act. and rear panels of the package and shall it bears one of the required warnings in (c) Irremovable or permanent comprise at least the top 50 percent of accordance with section 4 of the Federal warnings. The required warnings shall these panels; Provided, however, that on Cigarette Labeling and Advertising Act cigarette cartons, the required warning be indelibly printed on or permanently (15 U.S.C. 1333) and this part. A shall be located on the left side of the affixed to the package or advertisement. cigarette distributed or offered for sale front and rear panels of the carton and Such warnings, for example, must not in any State shall be deemed to be shall comprise at least the left 50 be printed or placed on a label affixed misbranded under section 903(a)(8) of percent of these panels. to a clear outer wrapper that is likely to the Federal Food, Drug, and Cosmetic (5) The required warning shall be be removed to access the product within Act unless the manufacturer, packer, or positioned such that the text of the the package. distributor includes in all required warning and the other advertisements and packages issued or § 1141.12 Incorporation by reference of caused to be issued by the information on that panel of the package required warnings. have the same orientation. manufacturer, packer, or distributor (b) Advertisements—(1) It shall be ‘‘Cigarette Required Warnings’’ with respect to the cigarette one of the unlawful for any manufacturer, Edition 1.0 (June 2011), consisting of required warnings in accordance with importer, distributor, or retailer of electronic files, U.S. Food and Drug section 4 of the Federal Cigarette cigarettes to advertise or cause to be Administration, referred to at § 1141.3, Labeling and Advertising Act (15 U.S.C. advertised within the United States any § 1141.10(a) and (b), and § 1141.16(a), is 1333) and this part. cigarette unless its advertising bears, in incorporated by reference into this Subpart C—Additional Disclosure accordance with section 4 of the Federal section with the approval of the Director Requirements for Cigarette Packages Cigarette Labeling and Advertising Act of the Federal Register under 5 U.S.C. and Advertising (15 U.S.C. 1333) and this part, one of the 552(a) and 1 CFR part 51. To enforce required warnings. any edition other than that specified in § 1141.16 Disclosures regarding (2) The text in each required warning this section, FDA must publish notice of cessation. shall be in the English language, except change in the Federal Register and the (a) The required warning shall that: material must be available to the public. include a reference to a smoking (i) In the case of an advertisement that All approved material is available for cessation assistance resource in appears in a non-English publication, inspection at the National Archives and accordance with, and as specified in, the text in the required warning shall Records Administration (NARA). For ‘‘Cigarette Required Warnings’’ appear in the predominant language of information on the availability of this (incorporated by reference at § 1141.12). the publication whether or not the material at NARA, call 202–741–6030 or advertisement is in English; and (b) In meeting the smoking cessation go to http://www.archives.gov/ needs of an individual caller, the (ii) In the case of an advertisement _ that appears in an English language federal register/ smoking cessation assistance resource _ _ _ publication but that is not in English, code of federal regulations/ required to be referenced by paragraph _ the text in the required warning shall ibr locations.html. Also, you may (a) of this section must, as appropriate: appear in the same language as that obtain a copy of the material by (1) Provide factual information about principally used in the advertisement. contacting the Center for Tobacco the harms to health associated with (3) For English-language and Spanish- Products, Food and Drug cigarette smoking and the health language warnings, each required Administration, Office of Health benefits of quitting smoking; warning shall be obtained from the Communication and Education, ATTN: (2) Provide factual information about electronic images contained in Cigarette Warning File Requests, 9200 what smokers can expect when trying to ‘‘Cigarette Required Warnings,’’ which Corporate Blvd., Rockville, MD 20850, quit; is incorporated by reference at 1–877–CTP–1373, or (3) Provide practical advice (problem § 1141.12, and accurately reproduced as [email protected]. You solving/skills training) about how to specified in ‘‘Cigarette Required may also obtain the material at http:// deal with common issues faced by Warnings.’’ www.fda.gov/cigarettewarningfiles. smokers trying to quit;

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(4) Provide evidence-based advice (6) Maintain appropriate controls to that country’s introduction, in about how to formulate a plan to quit ensure the criteria described in December 2000, of graphic warning smoking; paragraphs (b) and (c) of this section are labels both involve several steps. In both (5) Provide evidence-based met. methods, the first step is to estimate the information about effective relapse (d) If the Secretary of the Department smoking rate trend for Canada in the prevention strategies; of Health and Human Services years from 1991 up to and including (6) Provide factual information on (Secretary) determines that a part of the 2000. (We perform a similar analysis for smoking cessation treatments, including smoking cessation assistance resource the United States, but this will be used FDA-approved cessation medications; referenced by paragraph (a) of this only in the primary method.) and section does not meet the criteria (7) Provide information, advice, and described in paragraphs (b) and (c) of In response to comments on the support that is evidence-based, this section, the Secretary shall take Preliminary Regulatory Impact Analysis unbiased (including with respect to appropriate steps to address the of the proposed rule, we refine our products, services, persons, and other noncompliance. estimate of the Canadian smoking rate entities), and relevant to tobacco Dated: June 9, 2011. trend by accounting for tax changes at cessation. the Federal and provincial levels. The (c) The smoking cessation resource Margaret A. Hamburg, Commissioner of Food and Drugs. Ontario Flue-Cured Tobacco Growers’ must: Marketing Board (Ref. 174) reports time (1) Other than as described in this Dated: June 9, 2011. series of cigarette taxes for Canadian section, not advertise or promote any Kathleen Sebelius, provinces and territories. (Because these particular product or service; Secretary of Health and Human Services. (2) Except to meet the particularized time series only extend back to 1991, we needs of an individual caller as Note: The following Appendices will not have had to estimate a shorter time determined in the context of individual appear in the Code of Federal Regulations. trend than the one used in the analysis of the proposed rule.) We find average counseling, not selectively present Appendices information about a subset of FDA- tax levels for all of Canada by weighting approved cessation products or product I. Technical Appendix X1: Smoking Rates by provincial and territorial populations categories while failing to mention other II. Technical Appendix X2: Life-Years (using Ref. 175). We then adjust FDA-approved cessation products or III. Technical Appendix X3: Timing of nominal cigarette taxes for general product categories; Benefits inflation using the broad Canadian CPI (3) Not provide or otherwise IV. Technical Appendix X4: Timing of Costs (Ref. 176). (Canada has estimated a GDP V. Technical Appendix X5: Additional encourage the use of any drug or other deflator only since 2002, so we use the medical product that FDA has not Diagrams on Benefits VI. Technical Appendix X6: Uncertainty Canadian CPI, even though consumer approved for tobacco cessation; Analysis price indices tend to be characterized by (4) Not encourage the use of any non- A. Alternative Estimation of Smoking Rate slight upward biases in their estimates evidence-based smoking cessation Reduction of inflation.) Our results, along with practices; B. Monte Carlo Simulation (5) Ensure that staff providing results from an analogous estimation for smoking cessation information, advice, I. Technical Appendix X1: Smoking the United States, are reported in Table and support are trained specifically to Rates 42. help smokers quit by delivering FDA’s primary and secondary unbiased and evidence-based methods for estimating the reduction in information, advice, and support; and smoking rates realized in Canada due to

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Using the estimated time trend, we forecast and the actual Canadian smoking rate between 1994–2000 and forecast the Canadian smoking rate that smoking rate yields the portion of the 2001–09 yields the estimate of the effect would have been realized post-2000 had smoking rate that is unexplained apart of graphic warning labels, 0.574 graphic warning labels not been from the introduction of graphic percentage points, that appears in part introduced in that country. The warning labels. Calculating the (a) of Technical Appendix X6. difference between the smoking rate difference in the average unexplained

In our preferred estimation method Control and Prevention (Ref. 177) and United States and Canada. Finally, we (see section XI.D.1, above), we use the Jamison et al. (Ref. 178), population data again subtract the average for 1994–2000 U.S. experience as an additional control. from the U.S. Census Bureau (Refs. 179 from the average for 2001–09; this We find the unexplained smoking rate and 180), and inflation data from the produces the estimate that graphic in the United States using calculations U.S. Bureau of Economic Analysis (Ref. warning labels decrease the national analogous to those used for Canada and 132). We then calculate the difference in smoking rate by 0.088 percentage tax data from the Centers for Disease unexplained smoking rates between the points. Details appear in Table 44.

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II. Technical Appendix X2: Life-Years age of 24. Thus, it is necessary to specific former smoker survival ¥ In calculating expected life-years develop age-specific survival probability is 1 (2/3,399) = 0.99937. saved per dissuaded smoker, FDA relies probabilities for former smokers. (This technique for estimating former There are four possible events that a heavily on the life tables developed by smoker survival probability does not 24-year-old smoker can experience Sloan et al. (Ref. 116). The life tables are distinguish between recent quitters and between any two birthdays: staying calculated from the perspective of 24- those who quit many years ago. Not alive and remaining a smoker, staying year-olds, so the calculation of rule- making this distinction, which becomes alive and becoming a former smoker, induced effects on males and females increasingly important the further dying in the state of being a smoker, or who turn 24 sometime after the rule beyond age 25 we consider, will result dying in the state of being a former takes effect is relatively straightforward. in our estimates of cessation-related life smoker. The percentage of former expectancy benefits being too great for In the following example, we will show smokers who do not experience the last those who quit at an advanced age and the calculation of expected rule-induced of these events is the former smoker too low for those who quit at an early effects for 24-year-old females, under survival probability that we seek to age.) the assumption of a 3 percent discount calculate. We will illustrate this To find the expected number of life- rate; the calculations for males or for a calculation for 25-year-old females, years gained for a female who quits 7 percent discount rate would be under the assumption of a 3 percent smoking at age 25, we subtract from analogous. discount rate; the calculation for males 0.99937 the survival probability for a The life tables show that, of one or other discount rates or age categories smoker of the same age (calculated from hundred thousand females who smoke would be analogous. Sloan et al.’s typical smoker life table), at their 24th birthdays, 99,939 will We again consider one hundred then multiply by the discounted number survive to their 25th birthdays and thousand female smokers at their 24th of life-years lost if death occurs at age 99,876 to their 26th birthdays. Of one birthdays. According to the National 25 (previously found to be 29.8), and hundred thousand 24-year-old female Health Interview Survey (Ref. 128), 3.4 finally add the expected value of life- nonsmoking smokers, 99,946 will percent of them will become former years gained by quitting at age 26, survive to their 25th birthdays and smokers by their 25th birthdays. discounted 1 year. Because there is no 99,889 to their 26th birthdays. These Following Sloan et al., we use the 1998 extension of life brought about by numbers imply that, for every one NHIS and define former smokers as quitting at age 100, this addition is hundred thousand females who smoke individuals who quit at least 5 years in feasible for age 99, and then for age 98, at their 24th birthdays, smoking will the past. Sloan et al.’s life tables and so on back to age 25. The final cause seven deaths between birthdays indicate that another 61 of the original result for females who quit smoking at 24 and 25 and six deaths between one hundred thousand will die before age 25 is 0.081 discounted life-years birthdays 25 and 26. The tables their 25th birthdays; all 61 die in the saved. continue to show number of survivors state of being smokers (because no time For the year 2013, we multiply our in each category (and thus the smoking- has elapsed since they were smokers at estimated age-specific expected related excess probability of dying) for the definitional age of 24). This leaves discounted life-years saved by the every birthday up to age 100; the 96,540 who are alive and still smoking cohort sizes (for ages 18 and above) discontinuation of the tables at this and 3,399 who are living former projected by the U.S. Census Bureau point requires us to assume no survival smokers at the 25th birthday. (Ref. 130). For years 2014–31, we in either category to the one-hundred- Sloan et al.’s typical smoker life table multiply our estimated age-specific and-first birthday. indicates that 63 of these 25-year-old expected discounted life-years saved by Someone who dies at the age of 24 survivors will die before their 26th the cohorts that would not have been loses all the life-years up to and birthdays; we must calculate how many included in our 2013 calculation, including age 100. Without discounting, of them die in the state of being smokers specifically new 24-year-olds and older this would be a total of 77 years; with and how many in the state of being individuals whose cohorts grow from a 3 percent discount rate, however, the former smokers. To find death one year to another (for example, if the total is 29.9 years. Similarly, someone probabilities for those individuals who projected number of 35-year-olds in who dies at age 25 loses 76 are still smoking at age 25, we look to 2014 is greater than the projected undiscounted or 29.8 discounted life- Sloan et al.’s life table for lifetime number of 34-year-olds in 2013, the years. By multiplying together the age- smokers. Whereas the typical smoker difference is included in the 2014 specific discounted life-year loss and life table shows survival patterns for calculation). Finally, we estimate effects the age-specific smoking-related excess individuals who smoke at age 24 and for individuals who are 18–23 in the probability of dying, then summing over may quit sometime later in life, the year 2031 by discounting the present all ages, we arrive at the overall lifetime smoker life table isolates value of benefits accruing to 24-year- expected number of life-years saved per survival patterns for individuals who olds by the number of years until each dissuaded female smoker. Using a smoke at age 24 and continue to a cohort reaches that age threshold. discount rate of 3 percent, this result is specific age. The lifetime smoker life Results are further multiplied by FDA’s (7/100,000)*29.9 + (6/100,000)*29.8 + table will begin to diverge from the estimate of the rule-induced reduction … = 0.524. typical life table at later ages, but for in the U.S. smoking rate to yield our For individuals who are older than 24 birthdays 25 and 26, the results are once final estimate of the number of life-years at the time of the rule’s implementation, again 99,939 and 99,876 survivors; saved by the regulation. we want to perform a similar therefore, the percentage of 25-year-old calculation; however, direct application female smokers who survive to birthday III. Technical Appendix X3: Timing of of the nonsmoking smoker life tables is 26 is 99,876/99,939. Multiplying this Benefits inappropriate because the life percentage by the 96,540 smokers alive FDA’s estimated benefits appear as expectancy effect of smoking cessation at birthday 25 yields 61 deaths. undiscounted streams in Table 45, Parts at a particular age is almost certainly Therefore, two (=63¥61) deaths of 1 through 12. Benefits are realized as different than the effect of having former smokers are expected between late as 2113 because we calculate effects refrained from smoking since at least the birthdays 25 and 26, and the age- over lifetimes extending to age 100 for

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cohorts aged 18 and above during the assumptions would change the results have reported at the 7 percent discount first 20 years (2012 to 2031) of the final appearing in Table 45. Similarly, rate (an important exception being the rule’s implementation. because many of our sources report present value of reduced mortality for Because many of our sources report present values calculated only with a 24-year-olds because Sloan et al.’s life only present values of smoking-related discount rate of 3 percent, changing our tables allow us to know the timing of effects, estimating the timing of those assumptions about the timing of effects those benefits). effects requires us to make various would change the present values we BILLING CODE 4160–01–P assumptions. Changing those

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IV. Technical Appendix X4: Timing of Costs

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BILLING CODE 4160–01–C XI.D.2.b.v) of reduced smoking because percent consumer surplus reduction, V. Technical Appendix X5: Additional they include only the increased welfare based on a model created by Cutler (Ref. Diagrams on Benefits from improved health and expected 134). Several comments on the proposed longevity (and decreased welfare due to rule expressed concern about the Consumer Surplus Model. The subsidy loss) and do not account for any appropriateness of Cutler’s assumptions, benefits estimated in sections lost consumer surplus 21 associated with so FDA has revised the model to make XI.D.2.b.ii, XI.D.2.b.iii, XI.D.2.b.iv and the activity of smoking. In the it more applicable to the present XI.D.2.b.v overstate, all else held equal, Preliminary Regulatory Impact Analysis analysis. Our revised model is the net internal (i.e., intrapersonal) (see page 75 FR 69524 at 69544), FDA illustrated in Figure E1. benefits (or costs, in the case of section adjusted benefits estimates with a 50

21 The difference between what a consumer would be willing to pay for a good or service and what that consumer actually has to pay.

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We begin with a downward-sloping associated with smoking are not known between DCSfull and DCSmoney. We have demand for typical lifetime smoking. A or, if known, cannot be ‘‘internalized’’ drawn this as line DCSabsence. Our negative relationship between price and and incorporated into consumption finding that the graphic warning label consumption of cigarettes has been decisions. The current widespread regulation will reduce smoking rates is demonstrated empirically many times awareness that smoking poses health represented by an upward shift of this over (Chaloupka and Warner (Ref. 162) risks and the significant decline in line to DCSrule. (This may seem less review this literature). smoking rates over the past 50 years intuitive to some readers than shifting The height of line DCSfull marks the make it highly implausible that actual the demand curve—which is the full cost, including the cost of adverse consumption is near that hypothetical approach taken by Weimer et al. (Ref. health and life expectancy effects, of level. The intersection of the Demand 181)—but the two analytic methods will typical lifetime smoking (thus, the line and DCSfull represents the other produce equivalent results, as we ‘‘Discounted Cost of Smoking’’ or DCS), extreme. At that hypothetical level, illustrate below.) The intersections of while the height of line DCSmoney marks consumers are fully aware of all known DCSabsence and DCSrule with the demand only the after-tax price of cigarettes. The risks and have internalized all health curve show the number of smokers, height difference between these two costs and incorporated them into Qabsence and Qrule, in the absence and in lines is the sum of the per-person effects consumption decisions. The economic the presence of the final rule. we calculated in sections XI.D.2.b.ii, models and empirical studies of XI.D.2.b.iii and XI.D.2.b.iv. Also addiction, self–control, and time In the absence of the final rule, total cost, including health costs, for smokers belonging in DCSfull are the effects inconsistency (which we discuss in calculated in section XI.D.2.b.v because detail in our response to comments on is shown by the sum of areas B through the concept of the full cost of smoking, the preliminary analysis) strongly K. We reiterate that, even though as used in the model, is defined from suggest that health costs are not fully consumers do not internalize all costs the private perspective of the smoker internalized; the behaviors that lead to upfront, they do ultimately incur them. (and thus it is irrelevant whether or not less-than-full internalization appear to The gross value smokers place on there is someone else in society who be common. In surveys, many smokers cigarette consumption (known as experiences an effect that offsets the express a desire to quit and report that willingness-to-pay) is the area under the cost or benefit experienced by the they have tried to stop smoking. The demand curve as far right as Qabsence, or smoker—which is what distinguishes demand for various aids to smoking A+B+E+F+H+I+J+K. The net value to the entries in Tables 22 and 23 from the cessation provides further evidence of smokers of cigarette consumption is thus (A+B+E+F+H+I+J+K)¥ effects in sections XI.D.2.b.ii, XI.D.2.b.iii less-than-full internalization. Moreover, ¥ and XI.D.2.b.iv). While the elements in the immature judgments, short time (B+C+D+E+F+G+H+I+J+K) = A Tables 22 and 23 do contribute to horizons and lack of self-control of most (C+D+G). DCSfull, we posit that they should not be children and adolescents—who make In the presence of the final rule, total thought of as included in DCSmoney up the vast majority of new smokers— expenditure, including health costs, by because they are intricately related to suggest that policy interventions that smokers is B+C+E+H+J. Smokers’ the mortality and morbidity effects of prevent initiation and encourage willingness-to-pay is the area under the smoking that, unlike the after-tax price cessation can increase social welfare. demand curve as far right as Qrule, or of cigarettes, are likely characterized by For these reasons, we find it A+B+E+H+J. The net value to smokers time inconsistency, incomplete implausible that actual consumption is of cigarette consumption is thus information or other sources of market at the intersection of Demand and (A+B+E+H+J)¥(B+C+E+H+J) = A¥C. failure. DCSfull. The number of current smokers As a result, the effect of the rule is to Society will be at the intersection of is therefore found at the intersection of increase net value by Demand and DCSmoney if the health costs Demand with a line falling somewhere (A¥C)¥[A¥(C+D+G)] = D+G.

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The calculations appearing in sections DCSmoney, to be $5.78. FDA’s analysis in indicates that consumer surplus loss XI.D.2.b.ii, XI.D.2.b.iii, XI.D.2.b.iv and section XI.D.2.b of the benefits of offsets roughly 93 percent of rule- XI.D.2.b.v each consist of multiplying smoking reduction has produced an induced internal health benefits. An (Qabsence ¥ Qrule) by some portion of estimate of discounted internal health analogous calculation using the $7.50 (DCSfull ¥ DCSmoney); therefore, and financial effects (reduced mortality, per pack tax suggested by Gruber (Ref. summing the results of D2b.ii, D2b.iii, morbidity, medical costs and implicit 133) indicates that consumer surplus D2b.iv and D2b.v produces an estimate smoking subsidy) that ranges from $2.10 loss offsets roughly 76 percent of rule- of (D+F+G+I). Because we have already billion to $27.80 billion in total, or from induced internal health benefits. established that the benefit of the rule $4.56 to $27.69 per pack; this range Figures E2 and E3 illustrate the is (D+G), reporting the unadjusted sum indicates the range of potential height underlying model for the benefits of results from sections XI.D.2.b.ii, differences between DCSfull and analysis and the uncertainty associated XI.D.2.b.iii, XI.D.2.b.iv and XI.D.2.b.v DCSmoney. We can derive the heights of with the changes in consumer surplus would cause us to overestimate the the remaining DCS curves from a resulting from the final rule and other benefits of the final rule by an amount simulation conducted by Gruber and tobacco control policies. The diagrams equal to (D+F+G+I)¥(D+G) = (F+I). As Ko¨szegi (Ref. 104), in which they are elaborations on Figure E1, and lines drawn in Figure E1, (F+I) is estimate the tax rate that would allow and areas should be interpreted as approximately 50 percent of the time-inconsistent smokers to consume discussed in the explanation of that unadjusted estimate, (D+F+G+I). FDA the quantity that would be optimal figure. (Full internalization in Figure E2 does not claim that 50 percent is the under perfect rationality. Because this corresponds to DCSfull in Figure E1; no correct ratio; the correct ratio of (F+I) to quantity is found at the intersection of internalization in Figure E2 corresponds (D+F+G+I) is determined by the shape of the demand curve and DCSfull, Gruber to DCSmoney in Figure E1.) Both of the the demand curve as it divides areas F and Ko¨szegi’s tax result provides an diagrams below show the effects on and G and, more pertinently, by the estimate of DCSfull ¥ DCSabsence. Gruber lifetime smoking of differing degrees of relative height differences between and Ko¨szegi first estimate an internal average internalization of the full costs DCSfull and DCSrule and between health cost of $30.45 per pack. From of smoking. Figure E2 shows a rise in DCSabsence and DCSmoney. this, they calculate an internality tax the full price (equal to the money price (DCSfull¥DCSrule) may be much greater that ranges from $0.98 to $2.89 plus the internalized cost), while Figure than (DCSabsence¥DCSmoney) or it may be (depending on technical parameters of E3 shows a downward shift in demand much less, yielding a ratio that may be their model), with an average of $2.17. equal to the level where all costs are near zero or may be near 100 percent, FDA’s internal health and financial cost internalized; both diagrams illustrate depending on the starting height of estimates differ from Gruber and how the market evolves as it moves DCSabsence and the size of the policy- Ko¨szegi’s in a number of respects, leftward from the no-internalization induced reduction in smoking. including discount rate and use of a equilibrium to the full-internalization We now parameterize this model VSLY rather than value of a statistical equilibrium. We note that the net using the literature on the economics of life approach. We therefore scale the internal benefits to smokers of smoking habits and addiction. (We note, $2.17 internality tax estimate according reductions, shown as shaded triangles however, that rigorous quantitative to the ratio between our internal health or trapezoids above the full- welfare analyses of tobacco control and financial cost estimates and the internalization demand curve, are the interventions are rare in published, $30.45 result found by Gruber and same size in each diagram. Moreover, peer-reviewed literature, so the Ko¨szegi; this produces internality tax the area representing benefits decreases estimates generated below should not be estimates ranging from $0.33 to $1.98. in size as the size of the smoking viewed as definitive.) First, the Robert Subtracting these values from our population decreases. We assume that Wood Johnson Foundation (Ref. 137) estimates of DCSfull yields estimates of the market is currently at some reports that, as of 2009, State and DCSabsence ranging from $10.01 to intermediate point given by the Federal taxes made up 40.4 percent of $31.49. Knowing DCSabsence and Qabsence, intersection of one of the dashed (partial the total retail price of cigarettes. With we can use a Gruber and Ko¨szegi internalization) price lines with the the Federal cigarette excise tax being elasticity estimate, ¥0.803, to find the solid demand curve or the intersection $1.01 per pack (Ref. 164) and the height of DCSrule. This calculation yields of one of the dashed (partial population-weighted average State tax estimates of the difference between internalization) demand curves with the being $1.33 per pack (Ref. 165, with DCSrule and DCSfull that range from $0.27 solid money price line, but we are not population weights from Ref. 130), we to $1.81. If we assume a linear demand able to definitively estimate where that estimate the average after-tax price of a curve (in which case F will be 50 point is today or where it will be after pack of cigarettes, or the height of percent of the sum of F and G), this this final rule takes effect.

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VI. Technical Appendix X6: preceding sections, which only reflect A. Alternative Estimation of Smoking Uncertainty Analysis different estimates of the VSLY and Rate Reduction different discount rates. In this section, Estimation of the effectiveness of the we show the uncertainty associated Our primary estimate, that the U.S. rule (on reducing the future U.S. with our estimate of the effectiveness of smoking rate will decrease by 0.088 smoking rate) is subject to a large the rule. percentage points, was calculated in the uncertainty that is not fully reflected in following steps. First, we found the the benefits estimates appearing in the decrease in Canadian smoking rates

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since 1994 over and above what would that this proxy is inappropriate. To $1,681.0 million with a 3 percent have been expected using the pre-2001 account for this possibility, we calculate discount rate and $517.5 million with a trend and accounting for the effect of the unexplained difference in Canadian 7 percent discount rate (see Table 9b) to excise tax changes. We then subtracted smoking rates before and after graphic $10,916.6 and $3,360.7 million. We use the analogous unexplained decrease in warning labels were introduced, this these last two numbers as global upper the U.S. smoking rate over the same time omitting any U.S. adjustments. We bounds in Table 1. period. This second step was driven by assume that antismoking policies and Although both of the estimation the idea that the U.S. experience could programs other than the graphic proxy for recent social or policy changes warning labels are incorporated in the methods discussed thus far lead to the (such as public smoking restrictions) pre-2001 trend, with no additional conclusion that graphic warning labels that may have had effects on Canada’s effects of these variables occurring after will reduce smoking rates, FDA has had smoking rate and thus needed to be the introduction of graphic warning access to very small data sets, so our subtracted in order to isolate the effect labels. This approach indicates that effectiveness estimates are in general of graphic warning labels. The last step graphic warning labels may have been not statistically distinguishable from was to calculate the difference between responsible for a 0.574 percentage point zero; we therefore cannot reject, in a United States and Canadian decrease in the Canadian smoking rate. statistical sense, the possibility that the unexplained decreases in smoking If the rule were to achieve this rule will not change the U.S. smoking before and after graphic warning labels effectiveness level in the United States, rate. Therefore, the appropriate lower were introduced in Canada. We benefits would be approximately six bound on benefits is zero. Ranges of attributed the remaining unexplained times larger than those reported earlier benefits, representing the zero-effect difference to graphic warning labels. in this analysis. For example, our case and the Canada-only modeling However, the U.S. social and policy benefits estimates calculated with a approach, appear in Table 49. The wide climate may have been so different from VSLY of $318,923 and a net-to-gross ranges shown in the table highlight the Canada’s during the years 1994–2009 benefits ratio of 90 percent rise from uncertainty inherent in our approach.

B. Monte Carlo Simulation XI.D.2, we use two methods and several reduction in the national smoking rate, net-to-gross benefits ratios to produce a estimates of benefits accruing to the In addition to the uncertainty range of value estimates. For every general public (including fire loss and surrounding the effectiveness of graphic percentage point reduction in the financial effects) range from $6.1 to warning labels at reducing smoking national smoking rate, these estimates $14.7 billion (with a 3 percent discount rates, the other principal uncertainty in become $4.2 to $281.6 billion (with a 3 rate) or $4.3 to $11.6 billion (with a 7 our benefits analysis is the value to percent discount rate) or $1.3 to $61.1 percent discount rate). Details appear in smokers of cessation or avoided billion (with a 7 percent discount rate). Table 50. initiation. As discussed in section Similarly, for every percentage point

We estimate the 90th percentile range draw from discrete uniform pre-graphic warning label period. To for the present and annualized values of distributions an individual year’s account for uncertainty in the value to total benefits with a Monte Carlo United States-Canada adjusted smoking dissuaded smokers of cessation or simulation. We model the distribution rate difference from the graphic warning avoided initiation, we use for each of the decline in smoking rates with a label period (in Canada) and an discount rate and VSLY a uniform non-parametric bootstrap, in which we individual year’s difference from the distribution running from the lower

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bound estimate to the upper bound and some paired-year differences show when it has actually decreased, or vice estimate, as shown in Table 50. Benefits them increasing the smoking rate. (The versa. Because we expect this survey accruing to the general public are second finding is almost certainly due noise to overestimate the smoking rate modeled analogously, with a uniform to survey noise. More specifically, change in some years and underestimate distribution bounded below and above ordinary sampling variation will cause it in others, in our primary estimate, we by the values appearing in the table. We the percentage of smokers contained in take an average over all the years for run 100,000 iterations for each a survey sample to change from one year which we have data in order to estimate simulation and report our results in or country to the next; this is separate as reliably as possible the true Table 51. Both positive and negative from any underlying change in the true underlying change.) The wide results appear in the table because some smoking rate. Depending on the sizes differences in benefits shown in the paired-year United States-Canada and directions of the relative changes, a table highlight the uncertainty inherent differences show graphic warning labels comparison of country-year pairs can in our analysis. decreasing the Canadian smoking rate show the smoking rate increasing even

[FR Doc. 2011–15337 Filed 6–21–11; 8:45 am] BILLING CODE 4160–01–P

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