Receipt and Use of Tobacco Product Coupons among Adults Who Use Cigarettes, Cigars, and Smokeless Tobacco: Reasons for Use and Association with Subsequent Tobacco Product Purchases.

Beneficence or maleficence—big tobacco and smokeless products

Smokeless tobacco products: Unrecognised regulatory and policy opportunities

Tobacco industry direct mail receipt and coupon use among young adult smokers

FigureTobacco use is the leading preventable cause of disease and death in the United States, and nearly all tobacco use begins during youth and young adulthood.1,2 Among U.S. youths, cigarette smoking has declined in recent years; however, the use of some other tobacco products has increased,3 and nearly half of tobacco users use two or more tobacco products.4 CDC analyzed data from the 2013 National Youth Tobacco Survey to determine the prevalence of ever (at least once) and current (at least one day in the past 30 days) use of one or more of 10 tobacco products (cigarettes, cigars, hookahs, smokeless tobacco, electronic cigarettes, pipes, snus, bidis, kreteks, and dissolvable tobacco) among U.S. middle school (grades 6-8) and high school (grades 9-12) students. In 2013, 22.9 percent of high school students reported current use of any tobacco product, and 12.6 percent reported current use of two or more tobacco products; current use of combustible products (i.e., cigarettes, cigars, pipes, bidis, kreteks, and/or hookahs) was substantially greater (20.7%) than use of other types of tobacco. Also, 46.0 percent of high school students reported having ever tried a tobacco product, and 31.4 percent reported ever trying two or more tobacco products. Among middle school students, 3.1 percent reported current use of cigars, and 2.9 percent reported current use of cigarettes, with non-Hispanic black students more than twice as likely to report current use of cigars than cigarettes. Monitoring the prevalence of the use of all available tobacco products, including new and emerging products, is critical to support effective population-based interventions to prevent and reduce tobacco use among youths as part of comprehensive tobacco prevention and control programs. The National Youth Tobacco Survey is a cross-sectional, school-based, self-administered, pencil-and-paper questionnaire administered to U.S. middle school (grades 6-8) and high school (grades 9-12) students. Information is collected on tobacco control outcome indicators to monitor the impact of comprehensive tobacco control policies and programs5 and regulatory authorities of the Food and Drug Administration.6 A three-stage cluster sampling procedure was used to generate a nationally representative sample of students in grades 6-12. Of 250 schools selected for the 2013 National Youth Tobacco Survey, 187 (74.8%) participated, with a sample of 18,406 (90.7%) among 20,301 eligible students; the overall response rate was 67.8 percent. Participants were asked about ever and current use of cigarettes, cigars (defined as cigars, cigarillos, or little cigars), smokeless tobacco (defined as chewing tobacco, snuff, or dip), pipes, bidis, kreteks, hookah, snus, dissolvable tobacco, and e-cigarettes. Ever use was defined as ever trying a product, and current use was defined as using a product on one or more days during the past 30 days. For both ever use and current use, any tobacco use was defined as reporting the use of one or more tobacco products; use of two or more tobacco products was defined as reporting the use of two or more tobacco products in the specified time, current (in the past 30 days) or ever. Combustible tobacco was defined as cigarettes, cigars, pipes, bidis, kreteks, and/or hookahs. Noncombustible tobacco was defined as smokeless tobacco, snus, and/or dissolvable tobacco. A separate category was created for e-cigarette use. Data were adjusted for nonresponse and weighted to provide national prevalence estimates with 95 percent confidence intervals; statistically significant (p<0.05) differences between population subgroups were assessed using a t-test. Estimates for ever and current use are presented for each type of product, for any tobacco use, and for the use of two or more tobacco products by selected demographics for each school level (middle and high). In 2013, 22.9 percent of high school students reported current use of a tobacco product, including 12.6 percent who reported current use of two or more tobacco products. Among all high school students, cigarettes (12.7%) and cigars (11.9%) were the most commonly reported tobacco products currently used, followed by smokeless tobacco (5.7%), hookahs (5.2%), e-cigarettes (4.5%), pipes (4.1%), snus (1.8%), kreteks (0.8%), bidis (0.6%), and dissolvable tobacco (0.4%). Among high school students who identified as non-Hispanic white or Hispanic, cigarettes were the product most commonly used, whereas cigar use was more common for all other race/ethnicities. Cigar use among non-Hispanic black students was nearly 50 percent higher than cigarette use. Younger children are less likely to try tobacco than older children with the proportions of current any tobacco users and current users of two or more tobacco products being lower among middle school students (6.5% and 2.9%, respectively) than high school students (22.9% and 12.6%, respectively). Cigars (3.1%) and cigarettes (2.9%) were the most commonly reported tobacco products currently used by middle school students, followed by pipes (1.9%); smokeless tobacco (1.4%); e-cigarettes and hookahs (1.1%); and bidis, kreteks, and snus (0.4%). The proportions of ever users of any tobacco product and ever users of two or more tobacco products were higher among high school (46.0% and 31.4%, respectively) than middle school (17.7% and 9.4%, respectively) students. Combustible tobacco products were the most commonly used form of tobacco among both current and ever tobacco users. Among high school students, 20.7 percent currently used combustible products (13.5% combustible only; 3.4% combustible and noncombustible only; 2.7% combustible and e-cigarettes only; and 1.1% combustible, noncombustible, and e-cigarettes). Of all middle school students, 5.4 percent currently used combustible products (4.0% combustible only; 0.8% combustible and noncombustible only; 0.4% combustible and e-cigarettes only; and 0.2% combustible, noncombustible, and e-cigarettes). Current use of only e-cigarettes was 0.6 percent among high school students and 0.4 percent among middle school students. Continuing Efforts Needed In 2013, more than one in five high school students (22.9%) and more than one in 20 middle school students (6.5%) reported using a tobacco product on one or more days during the past 30 days. In addition, nearly half of high school students (46.0%) and almost one in five of middle school students (17.7%) had ever used tobacco. These findings indicate that continued efforts are needed to monitor and prevent the use of all forms of tobacco use among youths. Combustible tobacco use remains the most common type of tobacco use and causes most tobacco-related disease and death in the United States.1 Nine out of 10 high school current and ever tobacco users used a combustible tobacco product. There was lower use of only noncombustible tobacco products or only e-cigarettes among both current and ever tobacco users. However, noncombustible products also pose health risks.7 Smokeless tobacco is not a safe alternative to combustible tobacco because it causes cancer and nicotine addiction.7 In addition, although the long-term impact of e-cigarette use on public health overall remains uncertain, the 2014 Surgeon General's report found that nicotine use can have adverse effects on adolescent brain development; therefore, nicotine use by youths in any form (whether combustible, smokeless, or electronic) is unsafe.1 Most youths who currently use tobacco believe that they will be able to stop using tobacco in the near future; unfortunately, however, many continue use well into adulthood.2 Youths who report use of multiple tobacco products are at higher risk for developing nicotine dependence; about two thirds (62.9%) of youths who use more than one tobacco product report tobacco dependence symptoms, compared with 36.0 percent of those who use one tobacco product.8 Thus, youths who use multiple tobacco products might be more likely to continue using tobacco into adulthood. Comprehensive youth tobacco-prevention programs that prevent initiation of all types of tobacco products are critical to protect youths from tobacco use and nicotine dependence. Possible Limitations The findings in this report are subject to at least five limitations: First, data were collected only from youths who attended either public or private schools and might not be generalizable to all middle and high school-aged youths. Second, data were self-reported; thus, the findings are subject to recall and/or response bias. Third, current and ever tobacco use were estimated by including students who responded to using at least one of the 10 tobacco products included in the survey but might have had missing responses to any of the other nine tobacco products; missing responses were considered as nonuse, which might have resulted in conservative estimates. Fourth, nonresponse bias might have affected the results because the survey response rate was only 67.8 percent. Finally, estimates might differ from those derived from other nationally representative youth surveillance systems, in part because of differences in survey methods, survey type and topic, and age and setting of the target population. However, overall prevalence estimates are similar across the various youth surveys.2 Although substantial progress has been made in decreasing cigarette use among youths,2 overall tobacco use is still high, with one in five high school students currently using tobacco and nearly half reporting they have ever used a tobacco product. Ever using a tobacco product is a concern because even one-time use of tobacco is associated with increased long-term risks for becoming a regular user.2 In April 2014, FDA issued a proposed rule to extend its jurisdiction over the manufacture, marketing, and distribution of tobacco products not currently regulated by FDA, which includes cigars, e-cigarettes, pipes, and hookahs.9 FDA is reviewing the comments received on this proposed rule. Full implementation of comprehensive tobacco control programs at CDC-recommended funding levels would be expected to result in further reductions in tobacco use and changes in social norms regarding the acceptability of tobacco use among U.S. youths.1,2,10 Additionally, considering how trends in tobacco product use and tobacco marketing changes, rigorous surveillance of all available forms of tobacco use by youths, particularly emerging products such as e-cigarettes, is essential. Rigorous surveillance of the use of all types of tobacco will inform enhanced prevention efforts that could protect the estimated 5.6 million youths in the United States currently projected to die prematurely from a smoking-related disease.1 Reprinted (slightly adapted) from Morbidity and Mortality Weekly Report 2014;63;1021-1026.

In Response: Dr. Mirvish raises several timely and controversial issues that continue to be the focus of many vigorous discussions in the tobacco control community, often under the rubric of “harm reduction.” In 2006, WHO adopted the theme for World No Tobacco Day: “Tobacco: deadly in any form or disguise,” which supports the principle that there is no safe cigarette or smokeless tobacco—snus or otherwise. Currently, a WHO expert group, of which Dr. Hecht is a member, is in the process of finalizing a scholarly report that provides recommendations for “upper limits” for nitrosamines in combusted tobacco products. This document will provide guidance for countries interested and able to pursue tobacco product regulation. Basically, such product regulation looks to limit the morbidity and mortality of persistent use of a tobacco product. Current recommendations for public health policy are intended to be based on scientific evidence (1). The proposed recommendations for such upper limits are based on the precautionary premise resulting from data that currently exist that less must be better. We should never forget, however, “first, do no harm.” It is not known whether a recommended individual level of any specific constituent will result in decreased morbidity or mortality. Thus, product regulation recommendations must be couched in terms exemplified by the precautionary principle.In addition, there is no assurance that the tobacco industry will voluntarily solely market low-nitrosamine smokeless (or combusted) tobacco products. Product regulation by the appropriate agency in every country, such as the pending legislative effort in the United States, is necessary to attempt to assess and control the claims that the tobacco industry will be pursuing with ostensibly “safer” tobacco products. As concluded by the Institute of Medicine, the risk of reduced-harm products must be evaluated also at the population level where their introduction could delay quitting, reduce cessation, and increase initiation (2).The suggestion that reduced nitrate fertilizer be used by tobacco farmers is scientifically reasonable, but perhaps difficult to implement. The majority of countries in the world grow tobacco, and many of the tobacco farmers are quite poor, with little concern about the nitrate content versus the cost of the fertilizer. Reducing the use of nitrate fertilizer will need to be a requirement by the tobacco industries or regulated within the evolving policies emanating from the Framework Convention for Tobacco Control.Bottom line: Rather than recommending low-nitrosamine tobacco products as the method to reduce harm as Dr. Mirvish suggests, users should quit smoking and the use of smokeless tobacco. We can apply the precautionary principle and regulate the levels of nitrosamines, but there are no data to support that this reduction will reduce harm—yet. Funding for a safer cigarette should come from the tobacco industry, with federal oversight, not from the limited resources available for tobacco control and cancer research. The scientific community and regulatory agencies will need to evaluate any new evidence presented by the tobacco industry in support of claims for any purported “reduced-harm” tobacco products.

Tobacco companies continue to reach youth through direct-to-consumer marketing, which has been associated with overall tobacco use. We examine how exposure to these marketing activities influences product-specific use behaviors. We analyzed data from 10 081 youth (aged 12-18 years) who participated in Waves 1 and 2 (2013-2015) of the Population Assessment of Tobacco and Health (PATH) Study. Participants reported past 6-month tobacco coupon receipt and online tobacco marketing engagement, and susceptibility to ever and current use of cigarette, e-cigarettes, cigars, smokeless tobacco, and hookah. Weighted multivariable logistic regression examined Wave 1 predictors of coupon receipt at Wave 2, and associations between coupon receipt, online engagement, and past 30-day use of different tobacco products. Youth received tobacco coupons at one (9.7%) or both waves (1.2%) and 11.1% engaged with online tobacco marketing. Coupon receipt and online marketing engagement at Wave 1 predicted Wave 2 coupon receipt among susceptible-never, ever-but-not-current, and current tobacco users (p < .05). Coupon receipt and online engagement at Wave 1 was positively associated with past 30-day use of cigarettes, e-cigarettes, cigars, smokeless tobacco, and hookah at Wave 2 (p < .05). The relationships were stronger for those who received coupons at both waves or engaged with more sources of online marketing. Tobacco direct-to-consumer marketing is reaching youth. Repeated exposure to these marketing activities within and across media is associated with use of different tobacco products. New policies and strong enforcement of existing regulations prohibiting these illegal marketing tactics are critical to protect youth from future tobacco use. Tobacco companies utilize coupons and online engagement activities to increase brand awareness, knowledge, and sales of their products. These kinds of marketing activities can be influential among youth at a time when they may develop tobacco use behaviors. Our findings suggest that tobacco companies may be targeting at-risk youth through cross-media marketing activities. The findings also indicate that exposure to these marketing activities predicts subsequent use of different tobacco products, with suggestive dose-response relationships. Increased regulations are needed to protect youth from these marketing activities.

FigureSmokeless tobacco causes cancers of the oral cavity, esophagus, and pancreas.1 CDC analyzed National Health Interview Survey (NHIS) data to estimate the proportion of U.S. working adults who used smokeless tobacco in 2005 and 2010, by industry and occupation. This report describes the results of that analysis, which showed no statistically significant change in the prevalence of smokeless tobacco use among workers from 2005 (2.7%) to 2010 (3.0%). In 2010, smokeless tobacco use was highest among adults age 25 to 44 (3.9%), males (5.6%), non-Hispanic whites (4.0%), those with no more than a high school education (3.9%), and those living in the South (3.9%). By industry, the prevalence of smokeless tobacco use ranged from 1.5 percent in education services to 18.8 percent in mining industries, and by occupation from 1.3 percent in office and administrative support to 10.8 percent in construction and extraction. These findings highlight opportunities for reducing the health and economic burdens of tobacco use among U.S. workers, especially those in certain industries and occupations where use of smokeless tobacco is especially common. CDC recommends best practices for comprehensive tobacco-control programs, including effective employer interventions, such as providing employee health insurance coverage for proven cessation treatments, offering easily accessible help for those who want to quit, and establishing and enforcing tobacco-free workplace policies.2 NHIS is an annual, nationally representative, in-person survey of the noninstitutionalized U.S. civilian population. Questions about cigarette smoking are directed to one randomly selected adult in each surveyed family. In 2005 and 2010, data on cigarette smoking were collected from 31,428 and 27,157 persons, respectively. The same participants responded to a supplemental questionnaire that contained questions regarding the use of smokeless tobacco (i.e., chewing tobacco and snuff). The survey response rates for the adult core and supplemental questionnaire combined were 69.0 percent in 2005 and 60.8 percent in 2010. Survey participants were considered currently working if, when asked about their employment status during the week before their interview, they responded, “working at a job or business,” “with a job or business but not at work,” or “working, but not for pay, at a family-owned job or business.” (A total of 19,445 and 15,649 survey respondents were classified as currently working in 2005 and 2010, respectively.) Information on participants' current industry and occupation was coded by trained coders and grouped into 21 industry groups and 23 occupation groups. Current cigarette smokers were defined as respondents who reported having smoked at least 100 cigarettes during their lifetime and who reported currently smoking every day or some days. Current smokeless tobacco users were defined as those who reported using chewing tobacco or snuff at least 20 times in their lifetime and who reported currently using chewing tobacco or snuff every day or some days. Dual users were persons who were both current cigarette smokers and smokeless tobacco users. Sample weights were used to account for the complex sample design. Estimates with a relative standard error of 30 percent or more are not reported. Two-tailed t-tests were used to determine statistically significant differences between point estimates. The estimated number of adults age 18 and over who were working during the week before the interview was 141 million in 2005 and 139 million in 2010. Current smokeless tobacco use prevalence among working adults did not significantly differ from 2005 (2.7%) to 2010 (3.0%). The prevalence of smokeless tobacco use among working adults was highest among those 18 to 24 (3.6%) in 2005 and those 25 to 44 (3.9%) in 2010, and among males (4.9% and 5.6%, in 2005 and 2010, respectively), non-Hispanic whites (3.5% and 4.0%), those with no more than a high school education (3.6% and 3.9%), and those living in the Midwest (3.8% and 3.3%) or South (3.1% and 3.9%). Current cigarette smoking prevalence among working adults age 18 and over was 22.2 percent in 2005 and 19.1 percent in 2010. Among working adults who currently smoke cigarettes, the proportion who currently used smokeless tobacco (i.e., dual users) was 4.1 percent in 2005 and 4.2 percent in 2010. In 2010, dual use was greatest among the following subgroups of working adult smokers: those aged 18 to 24 (6.3%), males (7.3%), non-Hispanic whites (3.9%), those with no more than a high school education (4.5%), those with an annual household income of at least $75,000 (4.8%), and those living in the Midwest (5.3%). Among adult workers, the average number of cigarettes smoked per day was significantly higher among dual users (15.5) compared with those who used cigarettes only (12.1). 10 Industry Groups, 8 Occupation Groups Reliable 2010 estimates of smokeless tobacco use were available for workers in 10 industry groups. The prevalence of smokeless tobacco use in 2010 was highest among workers in the mining (18.8%), wholesale trade (8.9%), and construction (7.9%) industries. Reliable estimates of dual use among smoking workers were available only for construction (10.2%) and manufacturing (7.1%). Reliable 2010 estimates of smokeless tobacco use were available for workers in eight occupation groups. The prevalence of smokeless tobacco use in 2010 was highest among workers in construction and extraction (10.8%) and installation, maintenance, and repair (9.0%) occupations. No respondents in health care support occupations reported smokeless tobacco use. Reliable estimates of dual use among smoking workers were available only for construction and extraction (14.5%) and production (5.7%) occupations. In 2010, the prevalence of smokeless tobacco use among working adults (3.0%) exceeded the Healthy People 2020 target of no more than 0.3 percent for all U.S. adults, as did nearly all demographic and industry and occupation subgroups for which results are presented in this report. Although current cigarette smoking prevalence among working adults was significantly lower in 2010 (19.1%) than in 2005 (22.2%), the prevalence of smokeless tobacco use did not significantly differ from 2005 (2.7%) to 2010 (3.0%). The lack of reduction in smokeless tobacco use might be attributable to the introduction of novel smokeless tobacco products into the U.S. marketplace (e.g., snus and dissolvable tobacco), as well as increased expenditures on smokeless tobacco marketing in recent years.3,4 Tobacco industry advertising encourages cigarette smokers to use smokeless tobacco as an alternative in locations where smoking is not permitted.5,6 Additionally, research indicates that cigarette smokers might switch to smokeless tobacco for the purposes of harm reduction or smoking cessation.7 However, smokeless tobacco is not a safe alternative to combustible tobacco, and no conclusive scientific evidence currently exists showing that switching to smokeless tobacco promotes long-term cigarette smoking cessation.8 Because persons who concurrently use smokeless tobacco and cigarettes are less likely to report planning to quit than adults who smoke cigarettes exclusively,9 evidence-based interventions to reduce all forms of tobacco use are warranted. High-impact antitobacco media messages, comprehensive smoke-free policies, increased tobacco prices, and other interventions that prevent initiation and encourage cessation of tobacco products, in concert with sustained, comprehensive state tobacco control programs funded at CDC-recommended levels, are critical to decreasing tobacco use and reducing the health burden and economic impact of tobacco-related diseases in the United States.2 Limitations The findings in this report are subject to at least four limitations: First, because tobacco use information was self-reported and was not validated by biochemical tests, the extent of underreporting or overreporting of tobacco use could not be determined. Self-reported current cigarette smoking status has been shown to have a high validity,10 but the validity of self-reported smokeless tobacco use has not been established. Second, a limited sample size prevented the presentation of reliable estimates for some subpopulations. Third, the NHIS response rates of 69.0 and 60.8 percent might have resulted in nonresponse bias. Finally, the prevalence of smokeless tobacco use might be underestimated because certain smokeless tobacco products (e.g., snus) were not included in the NHIS questionnaire. Summary Health professionals can play an important role in assessing smokeless tobacco use and advising users to quit. Results from this report identify industry and occupation groups with a high prevalence of smokeless tobacco use where evidence-based cessation interventions could be effective in reducing tobacco use. Employers can help reduce tobacco use among employees by making their workplaces tobacco-free—which allow no use of any tobacco products (including cigarettes, cigars, pipes, smokeless tobacco products, or of electronic cigarettes—by anyone at any time. providing employees with information on the health risks of tobacco use and the benefits of quitting, and sponsoring workplace-based tobacco cessation services, including employer-sponsored health insurance that covers proven treatments for tobacco use and dependence.2 Such efforts can help to achieve the Healthy People 2020 objective to reduce smokeless tobacco use by adults to no more than 0.3 percent by 2020. Reprinted (slightly adapted) from Morbidity and Mortality Weekly Report 2014; 63;477-482.

Over the past half century, tobacco control arguably has been America's greatest public health success story. Antismoking campaign–induced decisions to quit smoking or not to start in the first place have translated into the avoidance of more than 5 million premature smoking-related deaths. On average, each of the affected individuals has gained 15 to 20 years of life expectancy as a consequence (1). This is a truly remarkable public health achievement.The glass-half-empty side of the story is that tobacco consumption, primarily in the form of cigarette smoking, remains by far the nation's leading behavior-related cause of death, illness, and disability. Four hundred and thirty thousand Americans lose their lives annually to smoking, active or passive, constituting a sixth of all deaths; another 9 million are ill or disabled as a result of smoking (2), and many observers worry that the steady decline in the prevalence of smoking over the past four decades might be slowing significantly, with a fifth of all adults remaining smokers (3). Evidence points to a more addicted population of continuing smokers. Compared with previous generations of smokers, they are less educated and more likely to work in blue collar occupations than in the past. Importantly, a substantial proportion of smokers suffer from a mental illness or substance abuse comorbidity (4). And yet, as in the past, a sizable majority reports that they would like to quit smoking cigarettes if they could.11http://www.gallup.com/video/109033/most-smokers-us-want-quit.aspxAlthough researchers in and outside of pharmaceutical companies seek more effective methods of helping smokers to quit, the tobacco industry, including both mainstream companies and a new cottage industry of innovators, has adopted a different approach: they are developing novel tobacco and nicotine-based products that, they hope, health-concerned smokers might adopt instead of smoking conventional cigarettes. The products range from cigarettes modified to reduce yields of specific toxins to low-nitrosamine forms of smokeless tobacco, from dissolvable tobacco lozenges to new electronic cigarettes (5, 6). Unlike the pharmaceuticals, these products have been brought to the market at the whim of their producers, subject to absolutely no regulation regarding their safety or efficacy as substitutes for conventional cigarettes.Until now, that is. In 2009, Congress passed and President Obama signed legislation giving the U.S. Food and Drug Administration (FDA) the responsibility for regulating aspects of the sale and marketing of cigarettes, smokeless tobacco, and related products.22http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1256enr.txt.pdf The agency's regulatory authority with regard to this product category differs dramatically from its responsibilities in its more traditional domains of pharmaceuticals, medical technologies, cosmetics, and food products, in which agency attention focuses narrowly on product efficacy and/or safety. Tobacco products are inherently unsafe, so the herculean task confronting the FDA will be to address issues of relative harm and population consequences of the introduction of novel products. Still, the critical fact is that companies wishing to bring novel tobacco and nicotine-related products to market will no longer be able to do so without regulatory approval. The FDA now also has the ability to impose performance standards for all tobacco products, including conventional ones. These performance standards would also be implemented in the context of relative harm.Just as the tobacco control story itself represents only half a victory, the multi-year battle to secure FDA regulation must be considered only a partial win for public health. We the people now have at least partial authority to regulate the marketing of what has historically been the world's most toxic category of legal products. However, we don't have complete authority, nor do we yet possess the wherewithal to do the job assigned to the FDA. At the core of effective regulation in all of FDA's domains lies a base of scientific knowledge, both the methods to assess the safety, efficacy, and toxicities of products and the results of years of research to develop a foundation of data upon which subsequent studies, and regulatory decisions, can rely. For the task of assessing the relative toxicity of myriad novel tobacco and nicotine-related products, the essential need to achieve sound regulation, the cupboard is nearly bare.Although the paucity of existent research represents a problem, it also constitutes a challenge and an opportunity. More precisely, it constitutes a challenge that is an opportunity, an opportunity to bring objective evaluation to a class of products that heretofore has wreaked havoc with the public's health, and thereby to reduce the morbidity and mortality associated with the core product, the cigarette. Although the interest in tackling this challenge in the United States is driven by the new FDA legislation, the opportunity it affords extends to all the world, for the toll of tobacco knows no geographic boundaries.Consider a subset of the new issues facing the FDA:The FDA will not face these challenges alone. Canada and the European Union have a decade of experience with product reporting requirements. The Conference of the Parties to the Framework Convention on Tobacco Control33http://www.who.int/fctc/cop/en/ will also begin to wrestle with these issues as protocols and implementation guidelines are developed under Articles 9 and 10 of that treaty, which deal with tobacco product regulations. The WHO's Study Group on Tobacco Product Regulation has produced two monographs (13, 14) and outlined proposals for maximal limits on toxicants (15) in a attempt to address major regulatory questions. However, much work remains to be done, particularly given the emergence of novel products around the world.To describe the resolution of scientific problems such as these merely as “challenges” risks grossly understating the difficulty and importance of resolving the problems. The scientific community must find the most effective ways to evaluate product-produced exposures and assess their effect on risks to health. They—we—must develop an effective surveillance system to monitor novel product usage and potential adverse health effects, and we have to develop means of ensuring that the tobacco companies do not subvert the process in practice or intent, a phenomenon for which they have shown substantial aptitude over the past many decades.Assessment of tobacco products includes each of the following:This CEBP focus section on tobacco research has nine core articles, all of which provide extensive critical reviews of their subject matter, focusing on research methodology. The articles range in their foci from studying tobacco products in the laboratory to evaluating their implications in the population. They provide a detailed review of the literature and of tobacco company citations. These articles should be useful for readers with questions on what we know about studying tobacco and the best methods for approaching what we do not know. The articles identify specific research gaps and make recommendations about how to address them. They do not, however, attempt to report what we know about tobacco use and harm per se. Rather, they report what we know about how to study them (and what we don't know) and how to move the field forward. They also serve as a model for studying other toxic exposures and human disease risk. Because they are not intended to summarize what we have learned about tobacco research to date, the reader will not discover lessons learned or a bottom line conclusion that could affect public health.Given our limited methodologies to address many of today's research questions about tobacco harm and harm reduction, two clichés come to mind: (a) “first things first” and (b) “garbage in, garbage out.” These articles are novel because they assess the methodologies that we have relied on so heavily in the past. In some cases, they have evolved from “folklore,” in others, they reflect limited science, and in still others, they derive from sound science. The articles in this section identify which are which.The articles do not cover everything that would-be tobacco regulators need to know. In part because they are covered in other excellent articles, biomarkers are not discussed in this section (16). Also missing is consideration of smoke chemistry studies, an area in which research methods are well-defined and reported, at least by using conventional smoking machine studies (17). A review of both methods and applications to tobacco product modifications and innovations is needed. The section also lacks a comprehensive review of the role of nicotine in product use and how nicotine delivery, in new products and old, affects product use and compensation. Finally, no article in this section addresses the final piece of the puzzle: how to integrate data across the various study types, while appropriately weighing the relative importance of each, to be followed by a risk assessment process considering risks to smokers. To begin, we need a conceptual framework for a comprehensive evaluation.These omissions notwithstanding, the articles included herein should serve as an important resource to the research community, to research funders, such as the NIH, and to the ultimate arbiters of what manufacturers can—and cannot—do with their new or modified products, the FDA and similar regulatory agencies around the world.As we venture into this new era of tobacco product innovation and regulation, it is imperative that we not lose sight of a scientific truth learned decades ago: the only certain way to reduce the harms associated with tobacco products is to avoid using them altogether. The new and essential search for means of evaluating novel products must not deflect the attention of the scientific community from the quest to prevent the initiation of tobacco use or the search to find effective means of quitting. However, the two objectives need not compete with each other for scarce tobacco control resources. This is not a zero sum game. With the advent of new regulatory authority, one hopes and indeed expects that the entire field of tobacco control research will be a vibrant—and more importantly, successful—growth industry.K.E. Warner: Consultant/Advisory Board, Pfizer.

Smokeless tobacco has been actively promoted by tobacco companies using endorsements by major sport figures, and research indicates that tobacco advertising can lead to youth initiation of tobacco use (1,2). Television and radio advertisements for cigarettes and smokeless tobacco have been prohibited since 1969,* and the 1998 Master Settlement Agreement(†) further prohibited tobacco companies from targeting youths with tobacco product advertisements in specified areas. In 2010, the Food and Drug Administration (FDA), under authority of the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), prohibited tobacco-brand sponsorship (i.e., sponsorship of sports and entertainment events or other social or cultural events using the tobacco brand name or anything identifiable with any brand of cigarettes or smokeless tobacco).(§) However, corporate-name tobacco sponsorship (i.e., sponsorship using the name of the corporation that manufactures regulated tobacco products) is still permitted under certain conditions.(¶) To monitor tobacco advertising and promotional activities in sports in the United States, CDC analyzed trends in sports-related marketing expenditures for cigarettes and smokeless tobacco during 1992-2013 using data from the Federal Trade Commission (FTC). During 1992-2013, sports-related marketing expenditures, adjusted by the consumer price index to constant 2013 dollars, decreased significantly for both cigarettes (from $136 million in 1992 to $0 in 2013) and smokeless tobacco (from $34.8 million in 1992 to $2.1 million in 2013). During 2010-2013, after the prohibition of tobacco-brand sponsorship in sports under the FSPTCA, cigarette manufacturers reported no spending (i.e., $0) on sports-related advertising and promotional activities; in contrast, smokeless tobacco manufacturers reported expenditures of $16.3 million on advertising and promoting smokeless tobacco in sports during 2010-2013. These findings indicate that despite prohibitions on brand sponsorship, smokeless tobacco products continue to be marketed in sports in the United States, potentially through other indirect channels such as corporate-name sponsorship. Enhanced measures are warranted to restrict youth-oriented tobacco marketing and promotional activities that could lead to tobacco initiation and use among children and adolescents (2). Reducing tobacco industry promotion through sponsorship of public and private events is an evidence-based strategy for preventing youth initiation of tobacco use (3). In addition, other proven interventions (e.g., tobacco price increases, anti-tobacco mass media campaigns, tobacco-free policies inclusive of smokeless tobacco, and barrier-free access to cessation services), could help reduce smokeless tobacco use in the United States (1).

Understanding which tobacco products adolescents use first can lead to insights for tobacco prevention interventions and policies. We used cross-sectional data from high school students who reported ever using a tobacco product from the 2017 North Carolina Youth Tobacco Survey (n = 1,053). In multivariable regressions, we examined how demographic and psychosocial factors were associated with adolescents’ first product tried and how first product tried was associated with current tobacco use (i.e., no use, use of a single product, use of multiple products) and frequency of tobacco use. Cigarettes (34.8%) and e-cigarettes (33.7%) were the most frequently reported first products tried, followed by cigars (15.6%), smokeless tobacco (10.7%), waterpipe (4.0%), and other tobacco products (i.e., pipe tobacco or some other tobacco product) (1.2%). Demographic differences in adolescents’ first product tried existed, with Black adolescents having higher odds of initiating tobacco use via cigars (aOR: 6.17, 95% CI: 3.75, 10.14). Adolescents who initiated tobacco use via cigars (aOR: 2.33, 95% CI: 1.31, 4.13) or smokeless tobacco (aOR: 2.45, 95% CI: 1.18, 5.04) had higher odds of being a multiple current tobacco product user, whereas adolescents who initiated tobacco use via e-cigarettes (aOR: 0.57, 95% CI: 0.34, 0.93) had lower odds of being a multiple current tobacco product user. Additionally, adolescents who initiated tobacco use via smokeless tobacco had higher odds of currently using at least one tobacco product frequently (aOR: 1.90, 95% CI: 1.04, 3.48), while adolescents who initiated tobacco use via e-cigarettes had lower odds of currently using at least one tobacco product frequently (aOR: 0.40, 95% CI: 0.23, 0.70). These findings suggest that most adolescents reported initiating tobacco use via cigarettes or e-cigarettes and that trying certain products first (e.g., cigars, smokeless tobacco) was associated with higher odds of multiple current tobacco product use.

Teen tobacco use: research and regulatory gaps.

The sustained anti-tobacco campaign initiated in response to the mounting evidence against tobacco smoking has driven tobacco companies and smokers to look for alternative choices, such as smokeless tobacco (SLT) products. If this strategy advances, it could undermine several gains made by the campaign over the years. Our objective was to examine the trends in the prevalence of different tobacco types in three countries (Bangladesh, India, and Nepal) of South-East Asia. Data from national surveys were used to estimate the trends of weighted and age-standardized prevalence (along with 95% CI) of different tobacco products. The share of each tobacco type was then calculated as a percentage of total tobacco use for each time point and country. In all the three countries, smoking prevalence declined (by 6% in Bangladesh, 3% in India, and 7% in Nepal) but SLT use increased (by 3% in Bangladesh, 6% in India, and 4% in Nepal) over the study period. SLT use increased irrespective of whether the total tobacco use increased or decreased. The share of SLT as a percentage of total tobacco use increased from 15% to 19% among Bangladeshi men, from 46% to 61% in India, and from 29% to 41% in Nepal. In South-East Asia, a clear shift in the product preference from smoking to SLT was noted. Misleading advertising by tobacco companies may be responsible for the increase in the SLT prevalence, which is as harmful as smoking. Countries should strengthen policies to restrict SLT usage and prevent the rise of its use. It has been documented that the smoking prevalence has been declining in most countries of the South-East Asia region where effective anti-tobacco laws have been implemented. But, due to a number of factors, the prevalence of smokeless tobacco has been increasing steadily, making the entire anti-tobacco movement less effective in terms of reducing the tobacco-attributable disease burden. In this context, this study has provided a detailed comparative analysis of the prevalence of smokeless tobacco use and smoking in three countries of the SEAR where such data were available. It can be clearly seen that the preference for smoking has shifted towards the smokeless tobacco in all the three study countries. This study recommends that tobacco control interventions should be aligned with the changing dynamics of the tobacco epidemic, and the need of the hour is placing restrictions of smokeless tobacco use so as to drive forward the gains of the anti-tobacco movement.

Health risk perceptions and reasons for use of tobacco products among clients in addictions treatment

Cancer survivors experience treatment-related complications that can be exacerbated by tobacco use. This study reports the prevalence of smokeless and dual tobacco use, compares these rates to the U.S. population, and examines tobacco risk factors among males surviving childhood cancer. Data from the Childhood Cancer Survivor Study (CCSS) 2007 survey were used (N = 3378). Standardized incidence ratios (SIR) were obtained by comparing CCSS data with the National Survey on Drug Use and Health. Logistic regression was used to evaluate associations between risk factors and tobacco use. Among male survivors, 8.3% and 2.3% were current smokeless tobacco and dual tobacco users, respectively. Survivors were less likely than population males to report smokeless tobacco [SIR = 0.64; 95% confidence interval (CI), 0.57-0.72) or dual tobacco (SIR = 0.37; CI, 0.29-0.46) use; however, non-White survivors aged 35 to 49 years were more likely to use smokeless tobacco (SIR = 2.32; CI, 1.27-3.90). Smokeless tobacco use was associated (P < 0.05) with younger age at diagnosis, lower education, being married or divorced/separated, and not living in the Northeastern United State, whereas history of cardiovascular- and/or pulmonary-toxic treatment was protective. Dual tobacco use was associated with younger age at diagnosis, lower education, divorce/separation, and high psychologic distress. Having active heart or circulatory conditions was protective. Although smokeless tobacco/dual tobacco use is generally low among childhood cancer survivors, these findings suggest that tobacco use screening should be expanded to include smokeless tobacco use, and that smokeless tobacco-specific education and cessation interventions should be provided to users. Screening and intervening for smokeless tobacco/dual tobacco use in childhood cancer survivors will reduce tobacco-related morbidity and mortality.

To assess the prevalence and correlates of use of conventional and novel smokeless tobacco products among a national sample of US middle and high school students. Data from the 2011 National Youth Tobacco Survey were analyzed to determine national estimates of current use of conventional ("chewing tobacco", "snuff," or "dip"), novel ("snus" and "dissolvable tobacco products"), and any smokeless tobacco products (novel and/or conventional products) within the past 30 days. The overall prevalence of current use of any smokeless tobacco product was 5.6% (n = 960). Among all students, 5.0% used chewing tobacco, snuff, or dip; 1.9% used snus; and 0.3% used dissolvable tobacco products. Among users of any smokeless tobacco, 64.0% used only conventional products, 26.8% were concurrent users of novel plus conventional products, whereas 9.2% exclusively used novel products. Approximately 72.1% of current any smokeless tobacco users concurrently smoked combustible tobacco products, and only 40.1% expressed an intention to quit all tobacco use. Regression analyses indicated that peer (adjusted odds ratio [aOR]: 9.56; 95% confidence interval [CI]: 7.14-12.80) and household (aOR: 3.32; 95% CI: 2.23-4.95) smokeless tobacco use were associated with smokeless tobacco use, whereas believing that all forms of tobacco are harmful was protective (aOR: 0.55; 95% CI: 0.38-0.79). Conventional smokeless tobacco products remain the predominant form of smokeless tobacco use. Most users of novel smokeless tobacco products also concurrently smoked combustible tobacco products. Smokeless tobacco use was associated with lower perception of harm from all tobacco products and protobacco social influences, indicating the need to change youth perceptions about the use of all tobacco products and to engage pediatricians in tobacco use prevention and cessation interventions.