Section 201 also states that ``the Secretary [of Health and Human Services] shall issue regulations that require color graphics depicting the negative health consequences of smoking'' to accompany the nine new health warning statements.

Section 202(b) of the Tobacco Control Act amends section 4 of FCLAA (15 U.S.C. 1333) to add a new subsection \1\ that permits FDA to, after notice and an opportunity for the public to comment, adjust the format, type size, color graphics, and text of any health warning statement if such a change would promote greater public understanding of the risks associated with the use of tobacco products. Similarly, section 202(b) of the Tobacco Control Act permits FDA to adjust the format, type size, and text of any other disclosures required under the FD&C Act, using the same process and upon the same basis as for adjusting the health warning statements.\2\ Among the provisions of the FD&C Act that provide authority to require disclosures is section 906(d) (21 U.S.C. 387f(d)). This provision authorizes FDA to issue regulations restricting the sale or distribution of cigarettes and other tobacco products, including restrictions on the advertising and promotion of such products, if FDA determines the restriction is appropriate for protecting the public health.
\1\ Section 202(b) of the Tobacco Control Act amends section 4 of FCLAA (15 U.S.C. 1333) to add a new subsection (d), ``Change in Required Statements.'' However, section 201 of the Tobacco Control Act also amends section 4 of FCLAA to add a new subsection (d), ``Graphic Label Statements.''
\2\ Provisions regarding adjustments to the health warnings and other disclosures are also in sections 4(b)(4) and 4(d) of FCLAA, as amended by section 201 of the Tobacco Control Act.

These requirements are supplemented by the FD&C Act's misbranding provisions, which require that product advertising and labeling include proper warnings. For example, a tobacco product is deemed misbranded under section 903(a)(1) or (a)(7)(A) of the FD&C Act (21 U.S.C. 387c(a)(1) or (a)(7)(A)) if its labeling or advertising is false or misleading in any particular. Under section 201(n) of the FD&C Act (21 U.S.C. 321(n)), in determining whether labeling or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. Similarly, under section 903(a)(8)(B) of the FD&C Act (21 U.S.C. 387c(a)(8)(B)), a tobacco product is deemed misbranded unless the manufacturer, packer, or distributor includes in all advertisements and other descriptive printed matter a brief statement of, among other things, the relevant warnings. Moreover, a tobacco product is deemed misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. 387c(a)(7)(B)) if it is sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act. Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA has authority to issue regulations for the efficient enforcement of the FD&C Act.

Cigarette smoking kills an estimated 443,000 Americans each year, most of whom began smoking when they were under the age of 18 (Ref. 1). Tobacco use is the foremost preventable cause of premature death in America, and has been shown to cause cancer, heart disease, and other serious adverse health effects (Ref. 2). In enacting the Tobacco Control Act, Congress found that providing FDA with authority to regulate tobacco products, including the advertising and promotion of such products, would result in significant benefits to the American public in human and economic terms (section 2(12) of the Tobacco Control Act). The U.S. government has a substantial interest in reducing the number of Americans, particularly children and adolescents, who use cigarettes and other tobacco products in order to prevent the lifethreatening health consequences associated with tobacco use (section 2(31) of the Tobacco Control Act). Virtually all new users of tobacco products are minor children and a reduction in tobacco use by this population alone could significantly reduce tobaccorelated death and disease in the United States (Ref. 3 at pp. 56).

In 1964, the Surgeon General of the Public Health Service issued the landmark report titled ``Smoking and Health,'' which
comprehensively assessed the available scientific evidence relating to the health effects of cigarette smoking and concluded that cigarette smoking is a health hazard of sufficient importance in the United States to warrant appropriate remedial action. Subsequently, Congress passed the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 (Pub. L. 8992); this legislation required that a printed warning appear on cigarette packages to warn consumers of the potential hazards of cigarette smoking. This warning requirement was modified by later amendments to FCLAA, including the Comprehensive Smoking Education Act (CSEA) of 1984 (Pub. L. 98474), which extended the warning requirement to cigarette advertising. The current requirements for cigarette package and advertising warning statements are set forth in FCLAA.

Although FCLAA has required the inclusion of textual health warnings on cigarette packages and in cigarette advertisements for many years, there is considerable evidence that the current warnings are given little attention or consideration by viewers (Id. at p. 168). These warnings, which have not changed in over twentyfive years, have been described as ``invisible'' and fail to convey relevant information in an effective way (Ref. 4; Ref. 5 at p. 291). The current warnings also fail to include any graphic component. In proposing this current regulation, FDA examined the scientific literature and found substantial evidence indicating that prominent warnings including a graphic component would offer significant public health benefits over the current warnings used in the United States (see Section III). FDA also found evidence of a strong worldwide consensus that effective tobacco health warnings should be large and should include a graphic image component. For example, the World Health Organization's (WHO) Framework Convention on Tobacco Control (FCTC),\3\ an evidencebased treaty that provides a regulatory strategy for addressing the serious negative impacts of tobacco products, calls for warnings that are rotating, ``large, clear, visible and legible.'' The treaty recommends that the warnings occupy 50 percent or more of the principal display areas, and states that they may be in the form of or include pictures or pictograms. WHO FCTC art. 11.1(b). Worldwide, over 30 countries/ jurisdictions have implemented pictorial warnings on tobacco packages and requirements for pictorial warnings are pending in several other countries/jurisdictions.\4\
\3\ There are 168 signatories to the WHO's Framework Convention on Tobacco Control as of August 2010. At this time, the United States is a signatory but has not ratified this treaty.
\4\ Countries/jurisdictions that have implemented pictorial warning requirements for tobacco packaging include: Australia; Belgium; Brazil; Brunei; Canada; Chile; Colombia; Cook Islands; Djibouti; Egypt; Hong Kong; India; Iran; Jordan; Latvia; Malaysia; Mauritius; Mexico; Mongolia; New Zealand; Pakistan; Panama; Paraguay; Peru; Romania; Singapore; Switzerland; Taiwan; Thailand; Turkey; United Kingdom; Uruguay; and Venezuela. Countries/
jurisdictions with pending requirements include: France; Guernsey, Honduras; Malta; Norway; Philippines; and Spain.

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Therefore, as directed by section 201 of the Tobacco Control Act, and in the interest of the public health, we are proposing to modify the required warnings that appear on cigarette packages and in cigarette advertisements to include color graphics depicting the negative health consequences of smoking. Specifically, we are proposing to add a new part 1141 to Title 21 of the Code of Federal Regulations, which would require new warnings on cigarette packages and in cigarette advertisements. These new required warnings would consist of the nine textual warning statements set forth in section 201 of the Tobacco Control Act accompanied by color graphics depicting the negative health consequences of smoking. As required by section 201 of the Tobacco Control Act, the new warnings would appear prominently on packages and in advertisements, occupying at least 50 percent of the area of the front and rear panels of cigarette packages and 20 percent of the area of advertisements. Under sections 201 and 202 of the Tobacco Control Act, FDA may adjust the type size, text, and format of the textual warning statements. For example, under section 4(d) of FCLAA (as amended by section 201 of the Tobacco Control Act), FDA may adjust the type size, text, and format as FDA determines appropriate so that both the textual warning statements and the accompanying graphics are clear, conspicuous, legible and appear within the specified area. Such adjustments, including adjustments to the text of some of the textual warning statements, are included for some of the new warnings FDA is proposing.

These proposed modifications to the warnings currently required in the United States would promote greater public knowledge of the health risks of using cigarettes and would help reduce the initiation of smoking and the prevalence of cigarette use among Americans, and thus help prevent the lifethreatening health risks posed by cigarettes. Specifically, the new required warnings are designed to clearly and effectively convey the negative health consequences of smoking on cigarette packages and in cigarette advertisements, which would help both to discourage nonsmokers, including minor children, from initiating cigarette use and to encourage current smokers to consider cessation to greatly reduce the serious risks that smoking poses to their health.
II. Cigarette Use in the United States and the Resulting Health Consequences

In the United States, cigarette smoking is the leading cause of preventable death and disease (Ref. 6), resulting in more deaths each year than AIDS, alcohol, illegal drug use, homicide, suicide, and motor vehicle crashes combined (Ref. 7). Each day, an estimated 6,600 Americans (nearly 4,000 of them under the age of 18) become new smokers (Ref. 8 at p. 59), and due to the highly addictive nature of cigarettes, many will find it difficult to quit smoking, despite the severe health risks associated with cigarette use. Most smokers begin smoking before they are 18 years old (Ref. 3 at p. 6)more than 80 percent of established adult smokers began smoking before age 18 (Ref. 9)and about half of adolescents who continue to regularly smoke will eventually die from smokingattributable disease (Ref. 10). Smoking causes at least 443,000 premature deaths annually in the United States, and each year cigarettes are responsible for approximately 5.1 million years of potential life lost, direct health care expenditures of approximately $96 billion, and at least $96.8 billion in annual productivity losses in the United States (Ref. 1). The public health benefits that would result from reducing the number of Americans who smoke, and thus preventing the lifethreatening consequences associated with cigarette use, are substantial.

A. Smoking Prevalence Among Adults and Children

Adults. A significant percentage of U.S. adults are cigarette smokers. For example, results from the 2009 National Health Interview Survey (NHIS) indicate that approximately 46.6 million U.S. adults (or 20.6 percent of the adult population) are cigarette smokers (Ref. 6). Among these adult smokers, the vast majority78.1 percent, or approximately 36.4 million peoplesmoke every day (Id.). There are also subsets of the adult population with smoking prevalence rates that are significantly higher than the overall average. For example, the highest prevalence rates have been observed in adults with low education levels. Data indicate that 49.1 percent of adults with a General Education Development certificate (GED) and 28.5 percent of adults with less than a high school diploma were current smokers in 2009, compared with 5.6 percent of adults with a graduate degree (Id.).

Children. Among children, data from the 2009 Youth Risk Behavior Survey (YRBS), a nationally representative survey of students in grades 912 in the United States, showed that almost half (46.3 percent) of U.S. high school students had tried cigarette smoking, and an estimated 19.5 percent of students were current cigarette smokers (Ref. 11 at p. 10). Of these current cigarette smokers, 7.8 percent reported that they had smoked more than 10 cigarettes per day on the days they smoked (Id. at p. 11). Overall, approximately 7.3 percent of high school students in 2009 were frequent cigarette users, and 11.2 percent of students under the age of 18 had been daily smokers at some point during their lifetime (Id. at pp. 1011). Furthermore, followup studies of youth smokers have indicated that a significant number of students who are light smokers (i.e., students who are not daily smokers or who smoke less than 10 cigarettes per day) in high school will become heavy smokers after leaving high school (Ref. 12).

Trends. During the period of 19982009, the proportion of U.S. adults who were current cigarette smokers declined from 24.1 percent to 20.6 percent. However, the proportion did not decline from 2008 to 2009 (20.6 percent in both years), and during the fiveyear period of 2005 to 2009, rates showed virtually no change (20.9 percent in 2005 and 20.6 percent in 2009) (Ref. 6).

For children, data from the YRBS show that smoking prevalence rates increased rapidly in the early 1990s, peaking around 1997. Prevalence then declined during the late 1990s, but the rate of decline slowed during 20032009 (Ref. 13). According to 2009 data from the University of Michigan's Monitoring the Future survey, cigarette smoking rates among 8th, 10th, and 12th grade U.S. students declined only slightly from 2007 to 2009, at a much slower pace than observed previously. Specifically, over the twoyear time period from 2007 to 2009, smoking prevalence fell by just 0.6, 0.9 and 1.5 percentage points among 8th, 10th, and 12th graders, respectively (Ref. 12). Data from this survey also indicate that the proportion of students who perceive a great risk associated with being a smoker has leveled off in the past several years (Id.).

B. Initiation of Smoking Among Adults and Children

As discussed in section II.A, roughly onefifth of Americans are current cigarette smokers. Although the cigarette industry regularly loses customers through user cessation and
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through deaths caused by smoking, each year millions of U.S. adults and children become new smokers.

For example, results from the 2008 National Survey on Drug Use and Health (NSDUH) indicate that the number of persons aged 12 or older who smoked cigarettes for the first time within the past 12 months was 2.4 million (Ref. 8 at p. 59). This estimate was similar to the 2007 estimate (2.2 million) but statistically significantly higher than the estimates for 2002 (1.9 million), 2003 (2.0 million) and 2004 (2.1 million) (Id.). This 2008 estimate averages out to approximately 6,600 new cigarette smokers every day (Id.). Most of these new cigarette smokers (nearly 4,000) were under the age of 18 (Id.). However, it is also notable that the number of people who began smoking at age 18 or older showed a significant increase over the last several years, jumping from approximately 600,000 in 2002 to 1 million in 2008 (Id. at p. 60).

In addition, data from the 2008 NSDUH indicate that almost 1 million Americans aged 12 or older had started smoking cigarettes daily within the past 12 months. Of these new daily smokers, 37.2 percent (350,000 persons) were younger than age 18 when they started smoking daily. In other words, each day in 2008 approximately 1,000 U.S. children became new daily smokers (Id.). This is particularly concerning from a public health perspective, as studies suggest that the age individuals begin smoking can greatly influence how much they smoke per day and how long they smoke, which will ultimately influence their risk of tobaccorelated disease and death (Refs. 14 through 16). Data from animal studies also suggest that nicotine can cause permanent brain changes in the adolescent brain that lead to addiction and that these changes are greater in adolescents than in adults (Ref. 17). Furthermore, data from human studies indicate that the younger smokers start, the more likely they are to become addicted (Id.).

C. Costs to Society and Health Effects of Cigarettes

Cigarettes are responsible for premature deaths from a variety of diseases, a substantial burden on the U.S. healthcare system, and significant economic losses to society (Ref. 1). Smoking is the primary causal factor for at least 30 percent of deaths from cancer, including 90 percent of deaths from lung cancer, almost 80 percent of deaths from chronic obstructive pulmonary disease (COPD), and nearly onefifth of all deaths from cardiovascular disease (Ref. 1 and Ref. 2 at pp. 39 and 43).

1. Costs of Smoking to Society

Data from the Centers for Disease Control and Prevention's (CDC) SmokingAttributable Mortality, Morbidity, and Economic Costs (SAMMEC) system for 20002004, the most recent years for which analyses are available, indicate that cigarette smoking and exposure to cigarette smoke are responsible for at least 443,000 premature deaths each year (Ref. 1). For every person who dies from smoking, approximately 20 more people (8.6 million persons) suffer from at least one serious smoking related illness, primarily heart disease and COPD (Ref. 18). The three leading causes of smokingattributable death for current and former smokers were lung cancer, ischemic heart disease, and COPD (Ref. 1). Cigarettes also have significant deleterious effects on nonsmokers. For example, maternal smoking during pregnancy resulted in an estimated 776 infant deaths annually during 20002004, and each year an estimated 49,400 lung cancer and heart disease deaths were attributable to exposure to secondhand smoke (Id.).

Overall, each year cigarettes are responsible for approximately 5.1 million years of potential life lost, direct health care expenditures of approximately $96 billion, and at least $96.8 billion in productivity losses due to premature deaths in the United States (Id.). The total costs of smoking to society are much higher, as this estimate of productivity losses does not include costs associated with smoking related disability, employee absenteeism, or costs associated with secondhandsmoke attributable disease morbidity and mortality (Id.). These health care expenditures and productivity losses result in a combined economic burden from cigarette smoking of approximately $193 billion per year (Id.). There are also costs to the smoker and his or her family. One study estimated that the total cost of smoking over a lifetime, including private costs to the smoker and costs imposed on society (e.g., second handsmoke and costs of Medicare, Medicaid, and Social Security) come to nearly $40 per pack of cigarettes smoked (Ref. 19 at p. 11).

2. Negative Health Effects of Cigarettes

The healthcare burdens, productivity losses, and deaths attributed to smoking are related to an array of diseases and health conditions caused by cigarettes. Beginning with the landmark 1964 report ``Smoking and Health,'' the U.S. Surgeon General has issued a series of reports addressing the health consequences of smoking and nicotine addiction. According to the most recent Surgeon General's Report, ``The Health Consequences of Smoking,'' which summarizes thousands of peerreviewed scientific studies and is itself peerreviewed, smoking remains the leading preventable cause of death in the United States, and cigarettes have been shown to cause an everexpanding number of diseases and health conditions (Ref. 2 at pp. 9 and 25). As stated in the 2004 Report, ``[s]moking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general * * * [and] [q]uitting smoking has immediate as well as longterm benefits, reducing risks for diseases caused by smoking and improving health in general'' (Id. at p. 25). The following discussion presents a summary of some of the diseases and conditions caused by cigarettes, and of the impact smoking cessation has on some of these conditions.

Cancer. Cigarette smoking has long been tied to a variety of cancers. For example, there is overwhelming evidence that smoking causes lung cancer, and that the worldwide epidemic of lung cancer is attributable largely to smoking (Id. at p. 43). Studies indicate that the risk for developing lung cancer can be 20 or more times higher for smokers compared to lifelong nonsmokers, and the risk of lung cancer increases in smokers with the duration of smoking and the number of cigarettes smoked (Id.). There are extensive data showing that quitting smoking decreases the risk of lung cancer, and that this risk continues to decline as the duration of not smoking increases in comparison to the risk among continuing smokers (Id. at p. 49). However, the risk does not decline to the level of risk for those who have never smoked, even after 15 to 20 years of not smoking (Id. at p. 43).

It also has been established for some time that cigarette smoking also causes a variety of other cancers, including laryngeal cancer, oral cavity and pharyngeal cancers, esophageal cancer, and bladder cancer (Id. at pp. 62, 67, 116, and 167). Furthermore, smoking has also been shown to cause pancreatic cancer, kidney cancer, stomach cancer, cervical cancer, and acute myeloid leukemia (Id. at p. 25).

For all of these cancers, increasing smoking prevention and cessation would cause a significant decrease in the risk (Id. at ch. 2). For example, smoking cessation halves the risk for cancers of the oral cavity and esophagus as soon as five years after cessation (Id. at p. 117).

Cardiovascular disease. Smoking is causally related to all of the major
[[Page 69528]]
clinical cardiovascular diseases, with higher levels of smoking and longer duration of smoking increasing the risk of disease (Id. at p. 397). Heart disease and stroke are the main types of cardiovascular disease caused by smoking and represent the first and third leading causes of death in the United States (Id. at p. 363). Studies have shown that smokers have a 70 percent greater death rate from coronary heart disease than nonsmokers, a twofold to fourfold greater incidence of coronary heart disease, and a twofold to fourfold greater risk of sudden death than nonsmokers (Ref. 20 at pp. 5859). The beneficial impact of smoking cessation on these risks has also been well established. For example, one year after quitting smoking, a former smoker's additional risk of heart disease compared to a person who has never smoked is reduced by about half and, after 15 years of abstinence, this risk is similar to that of a person who never smoked (Ref. 2 at p. 363).

Current smoking is also associated with a twofold to fourfold increase in the risk of stroke; smoking cessation steadily decreases this risk and, after 5 to 15 years of not smoking, the risk of stroke is indistinguishable from that for lifetime nonsmokers (Id. at p. 394).

Smoking has also been shown to cause abdominal aortic aneurysm. Studies have shown that the risk of death from abdominal aortic aneurysm was increased more than fourfold in current smokers and twofold in former smokers; smoking is one of the few avoidable causes of this frequently fatal condition (Id. at pp. 39697).

Respiratory diseases. Smoking has negative effects on the entire lungit impairs lung defenses against infection and causes the sustained lung injury that leads to COPD (Id. at p. 423). Cigarettes have been shown to cause a range of acute respiratory illnesses, including increased risk of pneumonia, and chronic respiratory diseases, which are leading causes of illness and death in the United States and worldwide (Id. at pp. 423, 508509).

For example, cigarette smoking is the leading cause of COPD in the United States, and this major public health problem could be almost completely prevented by smoking abstinence (Id. at p. 501). Although smoking cessation reduces the risk of COPD, the risk of COPD mortality among former smokers, even after 20 years or more of abstinence, remains elevated compared with the risk among people who have never smoked (Id.).

Maternal smoking during pregnancy causes a reduction in lung function in infants, and children who smoke experience impaired lung growth and an early onset of lung function decline (Id. at pp. 508 509). Smoking during adulthood also leads to a premature onset of accelerated agerelated decline in lung function, while smoking cessation can return the rate of lung function decline to that of persons who have never smoked (Id. at pp. 480 and 509). Results from several investigations suggest that the benefits of smoking cessation for FEV1 decline (a measure of the air capacity of the lungs) are greatest for persons who stop smoking at younger ages (Id. at p. 480).

Smoking also results in poor asthma control and it causes a range of respiratory symptoms in children, adolescents, and adults, including coughing, phlegm, wheezing, and shortness of breath (Id. at p. 509). Smoking cessation reduces the rates of these respiratory symptoms and of respiratory infections (Id. at p. 467).

Reproductive effects. Smoking has welldocumented negative effects on fertility, on pregnancies, and on infants and children born to women who smoke. For example, studies show that women who smoke have reduced fertility (Id. at p. 541). Women who smoke during pregnancy are more likely to experience premature rupture of the membranes, placenta previa, and placental abruption (Id. at p. 576). Smoking also increases rates of preterm delivery and shortened gestation, and studies have indicated that women who smoke are twice as likely to have low birth weight infants as women who do not smoke (Id. at pp. 576 and 569). Smoking also causes an increased risk of sudden infant death syndrome (SIDS) for infants whose mothers smoke during and after pregnancy (Id. at pp. 587 and 601).

Other effects. Smoking has been shown to have a variety of other negative health effects. For example, cigarette smokers have poorer overall health status compared to nonsmokers; this may manifest as increased absenteeism from work and increased use of medical care services (Id. at p. 818). Smokers have an increased risk of adverse surgical outcomes related to wound healing and respiratory complications compared to nonsmokers (Id.). In postmenopausal women who smoke, smoking is associated with low bone density (Id. at p. 716). Smokers are also at an increased risk for hip fractures, which account for a significant proportion of the morbidity and mortality associated with osteoporosis (Id. at pp. 717719). Smoking also increases the risk for periodontitis, cataract, and for the occurrence of peptic ulcer disease in persons who are Helicobacter pylori positive (Id. at pp. 736, 777, 780 and 813). Furthermore, smokers are at a greater risk of dying from peptic ulcer disease than nonsmokers (Id. at p. 807).

Addiction. Nicotine addiction is another negative effect of cigarette smoking. Nicotine is the primary chemical compound in tobacco that causes addiction, and the magnitude of public health harm caused by cigarettes is inextricably linked to the addictive nature of these products (Ref. 21 at p. 14; Ref. 5 at p. xi). Nicotine is psychoactive (mood altering) and can provide pleasurable effects; it also causes physical dependence characterized by withdrawal symptoms that usually accompany nicotine abstinence (Ref. 21 at p. 14). The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine (Id. at p. 9). Smokers develop tolerance to the effects of nicotine over time as well as a physical dependence on these effects, and as a result need greater amounts of nicotine over time to produce the same effects; thus smokers tend to smoke more over time to avoid withdrawal symptoms (Id. at pp. 50, 19798). Withdrawal symptoms are common among persons attempting to quit smokingin one study, 78 percent of subjects reported significant withdrawal symptoms (Id. at pp. 201202).

In addition to physical dependence, nicotine addiction also results in conditioned behavior in smokers in response to situations and environmental stimuli associated with cigarette use. Smokers typically use cigarettes in certain patternse.g., upon waking in the morning, after a meal, with a cup of coffee or an alcoholic beverageand this patterned behavior is strongly reinforced by the pleasurable effects of nicotine (Id. at pp. 306308; Ref. 17). Other stimuli associated with smoking itself, such as the smell of cigarette smoke or the sight of cigaretteassociated paraphernalia, also become part of the conditioning process by repeated association with the desired physiological effects of nicotine (Ref. 21 at p. 307; Ref. 17). As these processes repeat over time as a result of regular smoking, these situations and stimuli become a powerful cue to smoke due to their association with the rewarding effects of nicotine, and the desire to smoke triggered by these situations can persist long after withdrawal symptoms subside (Ref. 17).

As a result of nicotine addiction, only a minority of smokers can achieve permanent abstinence in an initial quit
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attempt. There are data suggesting that more than 70 percent of smokers in the United States report that they want to quit, and approximately 44 percent report that they try to quit each year (Ref. 19 at p. 15). This estimate is likely a significant underestimate of the actual number of quit attempts because unsuccessful quit attempts, particularly if shortlived or in the past, are often not reported in surveys. One study reported that at three months, 90.1 percent of quit attempts lasting less than one day, 63.7 percent of those lasting between a day and one week, and 38.9 percent of those lasting between one week and one month failed to be reported to researchers conducting surveys (Ref. 22). Many of the quit attempts that are reported are unsuccessful. For example, among the 19 million adults who reported attempting to quit in 2005, epidemiologic data suggest that only 4 to 7 percent were successful (Ref. 19 at p. 15). Similarly, the Institute of Medicine (IOM), considering data for 2004, found that although approximately 40.5 percent of adult smokers reported attempting to quit in that year, only between 3 and 5 percent were successful (Ref. 5 at p. 82). Furthermore, adults with education levels at or below the equivalent of a high school diploma have the highest smoking prevalence levels but the lowest quit ratios (i.e., the ratio of persons who have smoked at least 100 cigarettes during their lifetime but do not currently smoke to persons who report smoking at least 100 cigarettes during their lifetime) (Ref. 23).

Adolescents also experience low success rates when attempting to quit. Most Americans who use tobacco products begin using when they are under the age of 18 and become addicted before reaching the age of 18 (Refs. 3 and 7). Although many adolescents believe ``they can quit [smoking] at any time and therefore avoid addiction,'' nicotine dependence can be rapidly established (Ref. 5 at p. 89; see also Ref. 19 at p. 158). Research has shown that some adolescents report symptoms of withdrawal and craving within days or weeks of beginning to smoke (Ref. 24). As a result, many adolescents are nicotine dependent despite their relatively short smoking histories (Ref. 25). An analysis of data from the 2007 YRBS found that 60.9 percent of high school students who ever smoked cigarettes daily tried to quit smoking, but only 12.2 percent were successful (Id.). Research among adolescents also highlights their poor understanding of the difficulty of quitting smokingfor example, one study found that only 3 percent of 12th grade daily smokers estimated that they would still be smoking in 5 years, while in reality 63 percent of this population is still smoking daily 7 to 9 years later (Ref. 5 at p. 91).

Benefits of reduced prevalence. Dramatic declines in the deaths caused by the conditions discussed above can be achieved by further reducing smoking prevalence rates. Smoking cessation has major and immediate health benefits for men and women of all ages, regardless of health status (Ref. 26 at p. i). Smoking cessation decreases the risk of the health consequences of smoking, and former smokers live longer than continuing smokers. For example, persons who quit smoking before age 50 have onehalf the risk of dying in the next 15 years compared with continuing smokers (Id. at p. v).

More importantly, preventing nonsmokers, particularly children, from starting smoking in the first instance would allow them to avoid nicotine addiction and the severe adverse health consequences of smoking. Preventing initiation would result in enormous public health benefits. As Congress found when enacting the Tobacco Control Act, ``reducing the use of tobacco by minors by 50 percent would prevent well over 10,000,000 of today's children from becoming regular, daily smokers, saving over 3,000,000 of them from premature death due to tobaccoinduced disease. Such a reduction in youth smoking would also result in approximately $75,000,000,000 in savings attributable to reduced health care costs'' (section 2(14) of the Tobacco Control Act). III. Data Concerning Health Warnings
A. Current Warnings on Cigarette Packages and Advertisements Are Inadequate

Section 201 of the Tobacco Control Act requires FDA to issue regulations mandating the use of color graphics depicting the negative health consequences of smoking to accompany the nine warning statements that are specified in section 4(a)(1) of FCLAA (15 U.S.C. 1333(a)(1)). The warning statements must be randomly displayed (i.e., in each 12 month period, all of the different warnings must appear in as equal a number of times as is possible on each brand of the product and be randomly distributed in all areas of the United States in which the product is marketed) on cigarette packages and rotated quarterly in alternating sequence in cigarette advertisements, as provided by sections 4(c)(1) and 4(c)(2) of FCLAA (15 U.S.C. 1333(c)(1), (2)), as amended by the Tobacco Control Act. Congress directed that stronger and larger warning statements, accompanied by graphics, would replace the current textonly requirements. Data from studies indicate the current warnings on cigarette packages and advertisements are ineffective at communicating health risk information to consumers.

Cigarette packages and advertisements can be effective channels for communication of important health information. The warning on a cigarette package can provide a clear, visible vehicle to communicate risk at the most crucial time for smokers and potential smokers. Pack aday smokers are potentially exposed to warnings more than 7,000 times per year (Refs. 2729). When utilized effectively, cigarette packages and advertisements can serve as an important channel for communicating health information to broad national audiences that include both smokers and nonsmokers.

The inclusion of strong health warnings on packages and in advertisements can thus provide a critical opportunity to educate consumers about the health risks of cigarettes, support intentions among current smokers who want to quit or decrease cigarette consumption, and discourage nonsmokers, particularly youth, from initiating cigarette use. Prominent displays of warnings increase their effectiveness; larger warnings, with pictures, are more likely to be noticed by consumers, communicate information about health risks to consumers, and reinforce intentions among tobacco users who want to quit (Ref. 30).

However, cigarette warnings in the United States have not been changed or improved in more than 25 years. The unchanging nature of these warnings, as well as their relatively small size and lack of a graphic image component, severely impairs their ability to effectively communicate to consumers. Research has repeatedly illustrated that the current warnings used in the United States frequently go unnoticed or fail to convey relevant information regarding health risks. 1. Current Warnings Have Not Changed in More Than TwentyFive Years

In response to the Surgeon General's first major report on smoking and health in 1964, Congress passed FCLAA to require warning labels on all cigarette packages. The warning, which was required to be conspicuous and legible, was written in small print and located on one of the side panels of each cigarette package. It stated ``CAUTION: Cigarette Smoking May Be Hazardous to
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Your Health.'' This language appeared on all cigarette packs sold from January 1, 1966, through October 31, 1970. In 1969, Congress passed the Public Health Cigarette Smoking Act (Public Law 91222), which slightly modified the warning statement on cigarette packages, but did not yet require any warnings on cigarette advertisements. The new warning language, ``Warning: The Surgeon General Has Determined That Cigarette Smoking Is Dangerous to Health,'' appeared on cigarette packages sold in the United States from November 1, 1970, through October 11, 1985. In 1972, the Federal Trade Commission (FTC) issued consent orders requiring six major cigarette manufacturers and distributors to include in all their cigarette advertisements a clear and conspicuous disclosure of the warning required to be on packages (Ref. 31 at 460 65).

In 1981, the FTC issued a report to Congress that concluded that the thencurrent health warning labels had little effect on public awareness and attitudes toward smoking. The FTC stated that the existing warning likely was ineffective because it ``(1) is overexposed and worn out, (2) lacks novelty, (3) is too abstract, and (4) lacks personal relevance'' (Ref. 32 at pp. 716).

Subsequently, Congress again modified cigarette warnings by passing the CSEA, which required the following four rotational health warnings on packages and advertisements \5\:
\5\ Slightly different health warnings were required on outdoor billboard advertisements.

In addition, the law established the location and format for these warning statements and mandated that the warnings be rotated quarterly, which helped keep them from becoming stale. Despite a FTC
recommendation to change the size and shape of warnings, Congress retained the size and rectangular format of previous warnings.

More than twentyfive years have passed since these last changes, and there is a substantial body of evidence that these warnings do not effectively communicate information about the adverse health effects of smoking to the American public, as discussed in more detail below. Given the extreme hazards cigarettes pose to the public health, the revised warnings required under section 4 of FCLAA (15 U.S.C. 1333) and provided in this proposed rule are critical to the effective communication of the health risks of smoking, and should encourage current smokers to consider cessation and discourage nonsmokers from initiating use of cigarettes.

2. Current Warnings Often Go Unnoticed

The CSEA requires the current warnings to be ``conspicuous and legible'' with the same package location and font size required on the date of enactment (i.e., October 12, 1984). However, researchers have found that these health warnings go largely unnoticed and unconsidered by both smokers and nonsmokers. For example, a major study into tobacco policy in the United States by the IOM in 2007 concluded that U.S. package warnings are both ``unnoticed and stale'' (Ref. 5 at p. 291). The Chair of the IOM's Committee on Reducing Tobacco Use has described the warnings on cigarette packs as ``invisible'' (Ref. 4).

Research regarding warning statements in cigarette advertisements has shown similar results. For example, one study of the recall and eyetracking of adolescents viewing tobacco advertisements found: 43.6 percent of adolescents did not even look at the warning statement included in the advertisement; just 36.7 percent looked at the warning long enough to read any of its words; and the average viewing of the warning only accounted for 8 percent of the total viewing time (Ref. 33). Researchers in this study also determined that adolescents are unable to recall the content of the current cigarette warnings or to correctly recognize the warnings from a list, indicating that the current warnings are likely to be ineffective among younger consumers (Id.).

Another study of adolescents also found that they are not seeing, reading, and remembering health warnings on cigarette packages and advertisements (Ref. 34). In this study of ninthgrade students, only 32 percent of regular smokers recalled seeing one of the current warnings which states: ``Quitting Smoking Now Greatly Reduces Serious Risks To Your Health'' (Id.). In addition, almost 20 percent incorrectly reported having seen a simulated health warning that is not among one of the four current required warnings (Id.).

Data from a 1989 study indicate that consumers also fail to notice or read health warnings on outdoor billboards and taxicab cigarette advertisements (though these advertising media are no longer in common use). According to this study, which was published in the Journal of the American Medical Association, drivers only read the entire warning message on 5 percent of highway billboard advertisements and were only able to fully read the health warning on 18 of the 39 street advertisements used in this study (Ref. 35). Participants were unable to read, even partially, the Surgeon General's warnings in any of the 47 taxicab advertisements used in this study (Id.). Yet, those same consumers were able to identify the brand name and imagery on 100 percent of the highway billboards (Id.). Likewise, these participants were able to identify the brand name in 100 percent and the imagery in 95 percent of the taxicab advertisements (Id.). These results indicate that the current warnings are not appropriately conspicuous in advertisements compared to the rest of the advertising message, as discussed in more detail below.
3. Current Warnings Fail To Convey Relevant Information in an Effective Manner

Even when consumers notice and contemplate the current health warnings on cigarette packages and in advertisements, there is clear evidence that these warnings fail to appropriately convey crucial information such as the nature and extent of the health risks associated with smoking cigarettes. The current small, wordy textbased messages are ambiguous, providing less health information than is provided regarding many other consumer goods that have significantly less harmful impact on people's health (Ref. 36).

In its 2007 Report, the IOM concluded that the current U.S. warnings fail to convey relevant health information in an effective way (Ref. 5 at p. 291). The IOM cited an International Tobacco Control Policy Evaluation Study, which found that 85 percent of Canadian respondents cited packages (which, in Canada, contain prominent text and graphic health warnings) as a source of health information, while only 47 percent of U.S. smokers cited packages as a health information source (Id. at 294, citing Ref. 37).

Studies also have shown that the current warnings do not motivate consumers to look at them long enough to consider the concept being communicated. For example, researchers have found that the warning [[Page 69531]]
statements fail to attract attention or to make the consumer appropriately aware of the health risks of smoking (Ref. 38). In a study of U.S. and Canadian smokers and nonsmokers, researchers found that participants voluntarily examined warnings on Canadian packages, which include prominent text and graphics, for longer durations than U.S. package warnings, because the current textonly messages used in the United States are not memorable for consumers (Id.). The mere textual presentation of vague hazard information in the current U.S. warnings is not sufficient to motivate perceptions of risk (Id.).

The content and format of the current warnings have failed to successfully draw and hold consumers' attention, especially when placed in competition with the other text, images, and graphics that cigarette companies have used on packaging and in advertising, which have been thoroughly tested, regularly updated, and artfully crafted by tobacco companies. According to the most recent data from the FTC, tobacco companies spent approximately $12.49 billion on advertising and promotion in 2006 (Ref. 39 at p. 1). Tobacco companies frequently have employed marketing and advertising experts to craft campaigns with messages targeted to certain demographics (Ref. 40 at p. 7). The messages developed by companies in cigarette advertisements cover 96 percent of the space, are continuously updated to incorporate current trends, and are targeted based on market research. In contrast, the current health warnings cover only 4 percent of advertising space, are solely textual, are not targeted to any population group, and consist of only four rotating messages that have not been updated for more than two and a half decades. On cigarette packages, these warnings appear only on one side panel. As a result, the important health messages frequently are functionally invisible in comparison to the rest of the advertisement and package (Ref. 33 at p. 88).

Moreover, even if consumers notice the current warnings, those with less education may not be able to adequately comprehend the textonly messages. In its 2007 Report, the IOM expressed concern about the ability of consumers with less education to recall the information included in textbased messages (Ref. 5 at p. 295). The IOM cited a study of Canadian smokers' knowledge about the country's prior warning requirements, which, like the current U.S. health warnings, only contained four textual warning statements. In that study, researchers noted that comparatively few women with lower educational attainment were aware of messages warning of the impacts of smoking on life expectancy, heart disease, or pregnancy (Ref. 41). Because the current U.S. smoking population has various levels of education (including a high percentage of people with low educational attainment) and includes teenagers (who have yet to complete their education), the current text only warnings are inadequate.
B. Larger, Graphic Warnings Communicate More Effectively: International Experience

In 2001, Canada introduced graphic health warnings depicting the adverse health consequences of smoking on the upper 50 percent of the two primary panels of cigarette packages. Those warnings, like the warnings proposed here, include a photograph or other image, a marker word ``WARNING,'' and a warning statement. By mid2009, 28 countries also required graphic warnings and more countries are planning to do so.

In its 2007 Report, the IOM concludes that the available scientific evidence indicates that larger, graphic health warnings would promote greater public knowledge of the health risks of using tobacco and would help reduce consumption (Ref. 5 at p. 295). Similarly, an article published by WHO concludes that, taken as a whole, the research on graphic health warnings show that they are (1) more likely to be noticed than textonly warnings, (2) more effective for educating smokers about the health risks of smoking and for increasing the time smokers spend thinking about the health risks, and (3) associated with increased motivation to quit smoking (Ref. 42).

1. Getting Consumers' Attention

Several design features are associated with greater salience (i.e., noticeability and readability) of health warnings, including the size and position of warnings on the cigarette package. Smokers are more likely to recall larger warnings, as well as warnings that appear on the front of packages (Ref. 5 at p. C3). Warnings that include pictures or graphics likewise are more noticeable and more likely to be recalled than textonly warnings (Id. at p. C4).

In Canada, awareness of warnings on cigarette packages was almost universal among smokers and very high even among nonsmokers after that country required cigarette packages to display large, graphic warnings on the front and rear panels. In a 2001 crosssectional survey sponsored by the Canadian Cancer Society, 90 percent of Canadian smokers and 49 percent of nonsmokers noticed changes to the Canadian health warnings after the introduction of pictorial warnings (Ref. 43). Similarly, a survey of youth sponsored by Health Canada showed that 73 percent of those who have never smoked, 86 percent of ``puffers'' (i.e., those who had tried smoking but never smoked a whole cigarette), and 90 percent of those who have smoked beyond puffing reported seeing health warnings on cigarette packages in 2002, a year after the introduction of graphic warnings in Canada (Ref. 44). In a study of young adults, 98.5 percent of smokers, 88.9 percent of occasional smokers, and 67.5 percent of those who have never smoked reported that they were aware of the Canadian graphic health warnings (Ref. 45).

Survey evidence also shows that awareness of health warnings on cigarette packages increased significantly after Australia required large, graphic warnings in 2006. In one study, smokers were more likely to report that over the past month they noticed the enhanced warnings and read or looked closely at them compared to the old warnings (Ref. 46). Among students in year levels 8 to 12 in Melbourne, cognitive processing of cigarette warnings (i.e., reading, attending to, thinking and talking about the warnings) increased in the year that Australia adopted graphic warnings (Ref. 47). Developmental focus group research conducted for Australia as it considered whether to require graphic warnings similarly reported that graphic warnings on cigarette packs were potentially more likely to help people remember the health effects and warnings (Ref. 48).

Experimental studies also indicate that requiring large, graphic warnings would significantly increase the salience of health warnings on cigarette packages. In one experimental study, U.S. college students were shown images of the Canadian cigarette warnings and the current warnings appearing on cigarette packs sold in the United States. Compared to the U.S. warnings, the Canadian graphic warnings significantly increased aided recall of the warnings, increased depth of message processing, and increased the perceived strength of the message (Ref. 49). Similarly, in focus group research conducted among young adults in the United States, participants reported that the Canadian warnings were more visible and more informative than the warnings appearing on cigarette packages in the United States (Ref. 50).
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2. Influencing Consumers' Awareness of CigaretteRelated Health Risks

Large, pictorial warnings graphically convey the harm and danger that tobacco use causes, eliciting an immediate impact. Effective communication of the health risks associated with cigarette use is critical from a public health perspective, as smokers who perceive a greater health risk from smoking are more likely to want to quit and to be successful in their quit attempts (Ref. 37). National surveys conducted on behalf of Health Canada indicate that approximately 95 percent of youth smokers and 75 percent of adult smokers report that the Canadian pictorial warnings have been effective in providing them with important health information (Ref. 5 at p. 294). The 2001 survey conducted by the Canadian Cancer Society found that the country's pictorial warnings, which had recently been introduced, resulted in 58 percent of smokers reporting that they thought about the health effects of smoking more frequently than previously (Ref. 43). Among Canadian adult smokers in Ontario, 51 percent of study participants reported that the pictorial warnings made them think about the health effects of smoking (Ref. 51). Canadian smokers were more likely to report cigarette packages as a source of information about the health risks of smoking than smokers in the United States and other countries with textonly warnings (Ref. 37).

Similarly, a study conducted for officials in Australia found that graphic warnings increased participants' knowledge and awareness of the health risks of smoking, especially among current smokers and recent quitters (Ref. 52). A street intercept study in Australia suggests that graphic warnings may also increase smokers' perceptions of their personal risks of smoking. In that study, 51 percent of participants stated that the graphic warnings on cigarette packs increased their perceived risk of dying from smoking (Ref. 53).

Graphic warnings appear to influence risk perceptions among youth as well as adults. In a crosssectional survey of middle and high school students in Greece, participants were shown several graphic warnings prepared by the European Union as well as textonly warnings. Study participants consistently selected the graphic warnings as more effective in making them think about the effects of smoking on health (Ref. 54). Similarly, in a youth survey conducted by Health Canada, approximately twothirds of youth nonsmokers reported looking at the pictorial warnings at least once a week and, as indicated above, 95 percent agreed that the warnings had been effective in providing them with important information about the health effects of smoking (Ref. 5 at p. C5).

In an Internetbased study of current and former young adult smokers in the United States, the Canadian graphic warnings were rated as significantly more effective than the current U.S. warnings on cigarette packs for conveying concerns about the health risks of smoking (Ref. 55).

3. Impacting Smoking Intentions and Behaviors

In addition to increasing consumer awareness of the health risks of smoking, the proposed graphic warnings also seek to impact changes in smoking behavior. There are some studies indicating that large, graphic warnings increase smokers' intentions to quit smoking or motivate them to quit smoking.

The 2001 survey sponsored by the Canadian Cancer Society shows that 44 percent of adult smokers stated that the Canadian graphic health warnings increased their motivation to quit smoking (Ref. 43). In another study of Canadian young adults (ages 20 to 24), 37 percent of male participants and 48 percent of female participants reported that the warnings on cigarette packs led them to think about quitting smoking (Ref. 45). In this same study, 36 percent of male participants and 34 percent of female participants also indicated that the cigarette warnings might make young people less likely to start smoking. Some studies indicate that exposure to graphic warnings increases quit intentions among youth smokers as well. A study of Australian adolescents shows that experimental and established youth smokers thought more about quitting after the introduction of graphic warnings in Australia (Ref. 47).

There is also evidence suggesting that graphic warnings may be more effective at preventing youth initiation than textonly warnings. For example, in a crosssectional survey of middle and high school students in Greece where participants were shown several graphic warnings prepared by the European Union as well as textonly warnings, the adolescents rated the graphic warning labels as more effective in preventing them from smoking (Ref. 54).

A few studies also indicate that large graphic health warnings may increase quit attempts. In Canada, smokers who quit smoking after the introduction of graphic warnings were 2.78 times more likely to identify health warnings as a motivation for their quitting than former smokers who quit during the two years before graphic warnings appeared on Canadian cigarette packages (Ref. 29). In one Australian study, participants reported increased attempts to quit smoking after cigarette packs displayed graphic warnings, although there was no association with shortterm quit success (Ref. 46).

Some studies also indicate that large, graphic warnings may induce individual smokers to reduce consumption. The Canadian Cancer Society survey indicated that 21 percent of smokers reported that on one or more occasions they chose not to smoke a cigarette due to the warnings on cigarette packages (Ref. 43). The survey also indicated that 27 percent of participants reported that the thennew graphic warnings motivated them to smoke less inside their homes (Id.). In another study involving young adults in Canada, 22.6 percent of current male smokers and 26.6 percent of current female smokers reported that in the past month, noticing the warning on cigarette packages led them to decide not to have a cigarette (Ref. 45). In a study of Australian youth smoking behavior, adolescents who were experimenting with smoking or were established smokers indicated that they thought more about forgoing cigarettes after graphic warnings appeared on cigarette packages in 2006 (Ref. 47).

One study suggests that graphic warnings may help persons who have quit smoking remain abstinent from smoking. In that study, 26 percent of former smokers in Canada reported that the thennew graphic warnings on cigarette packages helped them remain abstinent (Ref. 29).

Canadian national survey data also suggest that graphic warnings may reduce smoking rates. Smoking prevalence among Canadians aged 15 or older dropped from 24 percent in 2000 (before the graphic warnings were introduced) to 22 percent in 2001 and 21 percent in 2002 (Ref. 56). It is not possible to draw a direct causal connection between the graphic warnings and these data because other smoking control initiatives, including an increase in the cigarette tax and new restrictions on public smoking also occurred during the same period. At the same time, however, these data are suggestive that large graphic warnings may reduce smoking consumption.

After considering the available scientific evidence, the IOM concluded in its 2007 Report that ``[o]n the basis of the evidence accumulated thus far, [larger,] graphic warnings of the kind required in Canada, Brazil and Thailand `would promote greater public understanding of the risks' of using
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tobacco and would help reduce consumption'' in the United States (Ref. 5 at p. 295).

C. Benefits of FDA's Proposed Required Warnings

FDA has carefully assessed the scientific literature studying the impact of graphic images on the salience (i.e., noticeability and readability) of warnings, on the effective communication of the health risks of smoking, and on changes to smoking behavior. Although much of the available research involved comparisons of warnings that differ in more than one aspect (i.e., text size, use of graphics, and number of images), the overall body of available research has illustrated that the use of large text, color graphics, and multiple rotating health statements will significantly improve the communication of the health risks of smoking to the general public in the United States and delay wearout of these important health messages.

Our assessment of the literature and our experience as a public health agency provide su

FOR FURTHER INFORMATION CONTACT

Gerie Voss or Kristin Davis, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 208503229, 8772871373, gerie.voss@fda.hhs.gov or kristin.davis@fda.hhs.gov.