In 2009, the Food and Drug Administration (FDA) was given the authority to regulate the manufacture, marketing, and distribution of tobacco products (1).Effective August 2016, this authority was extended to all tobacco products, including electronic cigarettes (e-cigarettes) (2).Section 704(a)(1) of the Food, Drug, and Cosmetic Act gives FDA authority to conduct investigations and inspections of manufacturers (i.e., any person who manufactures, fabricates, assembles, processes, or labels a tobacco product or imports a finished tobacco product for sale or distribution in the United States) to ensure compliance with applicable federal requirements (1,2).*In October and November 2016, unannounced inspections were conducted in 59 "vape shops" to learn about business and manufacturing practices, including whether establishments were retailers or manufacturers, and, among manufacturers, how the products sold were manufactured and whether the manufacturers were aware of FDA regulations regarding tobacco products.This report summarizes these first 59 inspections, which showed a lack of quality assurance programs, standard operating procedures, and full labeling of ingredients by the inspected manufacturers.Vape shops engage in activities that include selling electronic nicotine delivery systems (ENDS), ENDS replacement pieces, and ENDS premixed flavored "e-liquids" and mixing or preparing combinations of liquid nicotine, flavors, and other liquids for sale to consumers.Before an inspection was initiated, a notice of inspection was issued to the most senior staff member at the shop, who also received a summary of the findings once the inspection was closed.Sixty establishments in four states were selected; one smoking lounge that did not sell or manufacture products was excluded from subsequent analysis.The 59 inspected shops included 31 retailers that only sold finished products, 27 that were both manufacturers and retailers, and one manufacturer that did not sell to consumers.Personnel at all shops reported being aware of FDA tobacco product regulation.The remainder of this report focuses on the 28 manufacturers.Among the 28 manufacturers, 14 were small businesses employing approximately three persons each; the remaining 14 reported having a parent corporation, a subsidiary, or an * https://www.fda.gov/TobaccoProducts/Labeling/default.htm.

Tobacco use remains the leading cause of preventable disease and death in the United States (1). Despite declining cigarette smoking prevalence among U.S. adults, shifts in the tobacco product landscape have occurred in recent years (2,3). Previous estimates of tobacco product use among U.S. adults were obtained from the National Adult Tobacco Survey, which ended after the 2013-2014 cycle. This year, CDC and the Food and Drug Administration (FDA) assessed the most recent national estimates of tobacco product use among adults aged ≥18 years using, for the first time, data from the 2015 National Health Interview Survey (NHIS), an annual, nationally representative, in-person survey of the noninstitutionalized U.S. civilian population. The 2015 NHIS adult core questionnaire included 33,672 adults aged ≥18 years, reflecting a 55.2% response rate. Data were weighted to adjust for differences in selection probability and nonresponse, and to provide nationally representative estimates. In 2015, 20.1 % of U.S. adults currently (every day or some days) used any tobacco product, 17.6% used any combustible tobacco product, and 3.9% used ≥2 tobacco products. By product, 15.1% of adults used cigarettes; 3.5% used electronic cigarettes (e-cigarettes); 3.4% used cigars, cigarillos, or filtered little cigars; 2.3% used smokeless tobacco; and 1.2% used regular pipes, water pipes, or hookahs.* Current use of any tobacco product was higher among males; persons aged <65 years; non-Hispanic American Indian/Alaska natives (AI/AN), whites, blacks, and persons of multiple races; persons living in the Midwest; persons with a General Educational Development (GED) certificate; persons with annual household income of <$35,000; persons who were single, never married, or not living with a partner or divorced, separated, or widowed; persons who were insured through Medicaid or uninsured; persons with a disability; and persons who identified as lesbian, gay, or bisexual (LGB). Current use of any tobacco product was 47.2% among adults with serious psychological distress compared with 19.2% among those without serious psychological distress. Proven population-level interventions that focus on the diversity of tobacco product use are important to reducing tobacco-related disease and death in the United States (1).

The American Cancer Society’s Great American Smokeout is an annual event that encourages smokers to make a plan to quit smoking (1). The 42nd annual Great American Smokeout will be held on November 16, 2017. In the more than 50 years since the Surgeon General’s first report on smoking and health, cigarette smoking among U.S. adults has been reduced by approximately half. Nonetheless, since 1964, the year of that first report, an estimated 20 million persons have died because of smoking. Smoking remains the leading preventable cause of disease, disability, and death in the United States (2). About two out of three adult smokers want to quit smoking cigarettes, and approximately half of smokers made a quit attempt in the preceding year (2). However, in 2016, more than one in seven U.S. adults were current cigarette smokers (3). Getting effective help through counseling and use of medications can increase the chances of quitting by as much as threefold (4). Information and support for quitting smoking is available by telephone at 800-QUIT-NOW (800–784–8669). CDC’s Tips From Former Smokers campaign offers additional quit resources at https://www.cdc.gov/tips.

烟草使用是美国可预防性疾病和死亡的首要原因. 如果维持目前的吸烟率,那么预计有560万现今小于18 岁的美国人将因吸烟相关的疾病而过早死亡. 大部分烟草使用和成瘾始于青少年期和青年期. 美国疾病预防控制中心( CDC )和食品药品管理局( FDA )通过分析2011—2015 年美国国家青少年烟草调查( National Youth Tobacco Surveys, NYTS)的数据,阐明美国初中生(6~8年级)和高中生(9~12年级)当前(即过去30 d)7种烟草产品类型[卷烟、雪茄、无烟烟草、电子烟、水烟(用于吸烟的水烟斗)、烟斗和比迪烟(用天度烟叶卷制的小型进口卷烟)]的使用现状和趋势.2015 年,电子烟是初中生( 5 .3%) 和高中生(16.0%)最常使用的烟草产品. 2011—2015 年,初中生和高中生电子烟和水烟的当前使用人数明显增加,而传统烟草产品(如卷烟和雪茄)的当前使用人数则减少,因而整体的烟草产品使用人数没有变化. 2014—2015 年,初中生电子烟的当前使用人数增加,高中生水烟的当前使用人数减少;相比之下,初中生水烟的使用人数,高中生电子烟的使用人数,或初中生和高中生卷烟、雪茄、无烟烟草、烟斗或比迪烟的使用人数没有变化.

Tobacco use is the leading cause of preventable disease and death in the United States; if current smoking rates continue, 5.6 million Americans aged <18 years who are alive today are projected to die prematurely from smoking-related disease. Tobacco use and addiction mostly begin during youth and young adulthood. CDC and the Food and Drug Administration (FDA) analyzed data from the 2011-2015 National Youth Tobacco Surveys (NYTS) to determine the prevalence and trends of current (past 30-day) use of seven tobacco product types (cigarettes, cigars, smokeless tobacco, electronic cigarettes [e-cigarettes], hookahs [water pipes used to smoke tobacco], pipe tobacco, and bidis [small imported cigarettes wrapped in a tendu leaf]) among U.S. middle (grades 6-8) and high (grades 9-12) school students. In 2015, e-cigarettes were the most commonly used tobacco product among middle (5.3%) and high (16.0%) school students. During 2011-2015, significant increases in current use of e-cigarettes and hookahs occurred among middle and high school students, whereas current use of conventional tobacco products, such as cigarettes and cigars decreased, resulting in no change in overall tobacco product use. During 2014-2015, current use of e-cigarettes increased among middle school students, whereas current use of hookahs decreased among high school students; in contrast, no change was observed in use of hookahs among middle school students, use of e-cigarettes among high school students, or use of cigarettes, cigars, smokeless tobacco, pipe tobacco, or bidis among middle and high school students. In 2015, an estimated 4.7 million middle and high school students were current tobacco product users, and, therefore, continue to be exposed to harmful tobacco product constituents, including nicotine. Nicotine exposure during adolescence, a critical period for brain development, can cause addiction, might harm brain development, and could lead to sustained tobacco product use among youths. Comprehensive and sustained strategies are warranted to prevent and reduce the use of all tobacco products among U.S. youths.

The use of tobacco products during adolescence increases the risk for adverse health effects and lifelong nicotine addiction. In 2014, an estimated 4.6 million middle and high school students were current users of any tobacco product, of whom an estimated 2.2 million were current users of two or more types of tobacco products. Symptoms of nicotine dependence are increased for multiple tobacco product users compared with single-product users. CDC and the Food and Drug Administration (FDA) analyzed data from the 2014 National Youth Tobacco Survey (NYTS) to determine how frequently (the number of days in the preceding 30 days) U.S. middle school (grades 6–8) and high school (grades 9–12) students used cigarettes, e-cigarettes, cigars, and smokeless tobacco products. Among current users (≥1 day during the preceding 30 days) in high school, frequent use (≥20 days during the preceding 30 days) was most prevalent among smokeless tobacco users (42.0%), followed by cigarette smokers (31.6%), e-cigarette users (15.5%), and cigar smokers (13.1%); a similar pattern was observed for those who used during all 30 days. Among current users in middle school, frequent use was greatest among smokeless tobacco users (29.2%), followed by cigarette smokers (20.0%), cigar smokers (13.2%) and e-cigarette users (11.8%). Current use of two or more types of tobacco products was common, even among students who used tobacco products 1–5 days during the preceding 30 days: 77.3% for cigar smokers, 76.9% for cigarette smokers, 63.4% for smokeless tobacco users, and 54.8% for e-cigarettes users. Preventing youths from initiating the use of any tobacco product is important to tobacco use prevention and control strategies in the United States. Monitoring the frequency and patterns of tobacco use among youths, including the use of two or more tobacco products, is important to inform evidence-based interventions to prevent and reduce all forms of tobacco use among youths.

Tobacco use and addiction most often begin during youth and young adulthood. Youth use of tobacco in any form is unsafe. To determine the prevalence and trends of current (past 30-day) use of nine tobacco products (cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, tobacco pipes, snus, dissolvable tobacco, and bidis) among U.S. middle (grades 6-8) and high school (grades 9-12) students, CDC and the Food and Drug Administration (FDA) analyzed data from the 2011-2014 National Youth Tobacco Surveys (NYTS). In 2014, e-cigarettes were the most commonly used tobacco product among middle (3.9%) and high (13.4%) school students. Between 2011 and 2014, statistically significant increases were observed among these students for current use of both e-cigarettes and hookahs (p<0.05), while decreases were observed for current use of more traditional products, such as cigarettes and cigars, resulting in no change in overall tobacco use. Consequently, 4.6 million middle and high school students continue to be exposed to harmful tobacco product constituents, including nicotine. Nicotine exposure during adolescence, a critical window for brain development, might have lasting adverse consequences for brain development, causes addiction, and might lead to sustained tobacco use. For this reason, comprehensive and sustained strategies are needed to prevent and reduce the use of all tobacco products among youths in the United States.

We present a model of behavioral dynamics that combines a social network-based opinion dynamics model with behavioral mapping. The behavioral component is discrete and history-dependent to represent situations in which an individual’s behavior is initially driven by opinion and later constrained by physiological or psychological conditions that serve to maintain the behavior. Individuals are modeled as nodes in a social network connected by directed edges. Parameter sweeps illustrate model behavior and the effects of individual parameters and parameter interactions on model results. Mapping a continuous opinion variable into a discrete behavioral space induces clustering on directed networks. Clusters provide targets of opportunity for influencing the network state; however, the smaller the network the greater the stochasticity and potential variability in outcomes. This has implications both for behaviors that are influenced by close relationships verses those influenced by societal norms and for the effectiveness of strategies for influencing those behaviors.

Tobacco use and addiction most often begin during youth and young adulthood.1,2 Youth use of tobacco in any form is unsafe.1 To determine the prevalence and trends of current (past 30-day) use of nine tobacco products (cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, tobacco pipes, snus, dissolvable tobacco, and bidis) among U.S. middle (grades 6-8) and high school (grades 9-12) students, CDC and the Food and Drug Administration analyzed data from the 2011-2014 National Youth Tobacco Surveys (NYTS). In 2014, e-cigarettes were the most commonly used tobacco product among middle (3.9%) and high (13.4%) school students. Between 2011 and 2014, statistically significant increases were observed among these students for current use of both e-cigarettes and hookahs, while decreases were observed for current use of more traditional products, such as cigarettes and cigars, resulting in no change in overall tobacco use. Consequently, 4.6 million middle and high school students continue to be exposed to harmful tobacco product constituents, including nicotine. Nicotine exposure during adolescence, a critical window for brain development, might have lasting adverse consequences for brain development,1 causes addiction,3 and might lead to sustained tobacco use. For this reason, comprehensive and sustained strategies are needed to prevent and reduce the use of all tobacco products among youths in the United States. NYTS is a cross-sectional, schoolbased, self-administered, pencil-andpaper questionnaire administered to U.S. middle and high school students. Information is collected on tobacco control outcome indicators to monitor the impact of comprehensive tobacco control policies and strategies4 and inform FDA’s regulatory actions.5 A three-stage cluster sampling procedure was used to generate a nationally representative sample of U.S. students who attend public and private schools in grades 6 to 12. This report includes data from four years of NYTS (2011-2014), using an updated definition of current tobacco

Background: Among U.S. youth overall, cigars are the most commonly used tobacco product after cigarettes. However, youth who identify their products by brand names, not general terms like "cigar," may underreport use.Purpose: To examine changes in reported cigar (cigar, cigarillo, or little cigar) smoking among students following inclusion of cigar brand examples on the National Youth Tobacco Survey (NYTS).Methods: Data from the 2011 and 2012 NYTS and National Survey on Drug Use and Health (NSDUH) were analyzed in 2013 to estimate ever and current cigar smoking, overall and by race/ ethnicity. The 2012 NYTS included cigar brand examples (Black and Mild, Swisher Sweets, Dutch Masters, White Owl, Phillies Blunt) in the survey instructions and ever use question, but the 2011 NYTS and 2011 and 2012 NSDUH did not.Results: NYTS ever cigar smoking was higher in 2012 (27.8%) than 2011 (19.5%) among black students overall. Current cigar smoking was 60%-70% higher among black females and students aged >= 17 years, in 2012 than 2011. For black females, current cigar smoking (11.5%) was two times greater than that of white females (4.3%) in 2012, whereas the prevalence among these subgroups was comparable in 2011. Similar changes were not observed among these subgroups in the 20112012 NSDUH.Conclusions: This study highlights the high burden of cigar use among U.S. youth and suggests that NYTS ascertainment of cigar smoking may have improved by including brands. Disparities in cigar smoking need to be addressed to prevent and reduce all youth tobacco use. Published by Elsevier Inc. on behalf of American Journal of Preventive Medicine

Despite significant declines in cigarette smoking among U.S. adults over the past five decades, progress has slowed in recent years, and the prevalence of use of other tobacco products such as cigars and smokeless tobacco has not changed. Additionally, the prevalence of use of emerging products, including electronic cigarettes (e-cigarettes), has rapidly increased. This report provides the most recent national estimates of tobacco use among adults aged ≥18 years, using data from the 2012-2013 National Adult Tobacco Survey (NATS). The findings indicate that 21.3% of U.S. adults used a tobacco product every day or some days, and 25.2% used a tobacco product every day, some days, or rarely. Population-level interventions focused on the diversity of tobacco product use, including tobacco price increases, high-impact antitobacco mass media campaigns, comprehensive smoke-free laws, and enhanced access to help quitting, in conjunction with Food and Drug Administration (FDA) regulation of tobacco products, are critical to reducing tobacco-related diseases and deaths in the United States.

Background: A growing body of evidence suggests that tobacco dependence symptoms can occur soon after smoking onset and with low levels of use. However, limited data are available nationally and among non-cigarette tobacco users.Purpose: To examine the prevalence and determinants of tobacco dependence symptoms among adolescent tobacco users in the 2012 National Youth Tobacco Survey, a nationally representative, school-based survey of U.S. middle and high school students.Methods: Multivariate logistic regression was used to identify independent predictors of dependence symptoms among current users (i.e., past 30-day use) of cigarettes, cigars, or smokeless tobacco. Analyses were conducted in 2013 using SAS-callable SUDAAN, version 11 to account for the complex survey design.Results: Prevalence of tobacco dependence symptoms ranged from 20.8% (95% CI=18.6, 23.1) of current tobacco users reporting wanting to use tobacco within 30 minutes of waking to 41.9% (95% CI=39.3, 44.5) reporting recent strong cravings. Reporting of dependence symptoms was most consistently associated with polytobacco use, higher frequency of use, earlier initiation age, and female gender. A 2-4-fold increase in the odds of symptom reporting was found in adolescents using tobacco products on as few as 3-5 days compared to those who only used it for 1-2 of the past 30 days.Conclusions: A substantial proportion of U.S. adolescent tobacco users, including those with low levels of use, report symptoms of tobacco dependence. These findings demonstrate the need for full implementation of evidence-based strategies to prevent both experimentation and progression to regular tobacco use among youth. Published by Elsevier Inc. on behalf of American Journal of Preventive Medicine

The burden of death and disease from tobacco use in the United States has been caused overwhelmingly by cigarettes and other smoked tobacco products. In the United States, cigarette consumption declined during 2000-2011; however, consumption of cigars more than doubled during the same period. The cigar market includes diverse product types manufactured with a variety of shapes and sizes, filters, tips, flavors, and prices. Although national estimates of cigar consumption have been reported previously, data characterizing who smokes different cigar types are limited. A recent analysis from the 2012-2013 National Adult Tobacco Survey (NATS) found that more than one in 20 U.S. adults smoke cigars "every day," "someday," or "rarely". This report expands upon those findings, using data from the 2012-2013 NATS to further characterize cigar smokers by the usual type of cigar smoked using the following categories: little filtered cigars (LFCs), cigarillos/other mass market cigars (cigarillos/MMCs), and premium cigars. The findings indicate that among U.S. adults who smoke cigars, 61.8% usually smoke cigarillos/MMCs, 19.9% usually smoke premium cigars, and the remainder, 18.4%, usually smoke LFCs. These data can help to inform public health interventions to reduce the burden of adverse health effects caused by cigar smoking in the United States, including regulation.

Electronic cigarettes (e-cigarettes) have recently gained significant attention in the marketplace and in the media. However, limited information is available about the worldwide impact of e-cigarettes; most public health officials are calling for more data so they can more fully understand the potential risks and benefits of e-cigarettes in order to inform regulatory action. In the USA, e-cigarettes that are marketed as tobacco products are not currently regulated by the Food and Drug Administration (FDA). However, having a continuum of nicotine-containing products that cross jurisdictional lines within the FDA in the future would create the potential (and the need) for a comprehensive nicotine strategy at the FDA. As part of developing the most appropriate approach to e-cigarette regulation, FDA Center for Tobacco Products scientists have been reviewing the available literature to determine the state of e-cigarette knowledge and have identified research areas that could be addressed. This supplement provides a summary of the current knowledge and research gaps pertaining to e-cigarettes with regards to product design, chemistry and toxicology of e-liquid and aerosol constituents, human factor-based risk factors, abuse liability, clinical pharmacology and human health effects, paediatric issues, and environmental issues.