Tobacco-Product Use by Adults and Youths in the United States in 2013 and 2014.

BACKGROUND: Noncigarette tobacco products are evolving rapidly, with increasing popularity in the United States. METHODS: We present prevalence estimates for 12 types of tobacco products, using data from 45,971 adult and youth participants (≥12 years of age) from Wave 1 (September 2013 through December 2014) of the Population Assessment of Tobacco and Health (PATH) Study, a large, nationally representative, longitudinal study of tobacco use and health in the United States. Participants were asked about their use of cigarettes, e-cigarettes, traditional cigars, cigarillos, filtered cigars, pipe tobacco, hookah, snus pouches, other smokeless tobacco, dissolvable tobacco, bidis, and kreteks. Estimates of the prevalence of use for each product were determined according to use category (e.g., current use or use in the previous 30 days) and demographic subgroup, and the prevalence of multiple-product use was explored. RESULTS: More than a quarter (27.6%) of adults were current users of at least one type of tobacco product in 2013 and 2014, although the prevalence varied depending on use category. A total of 8.9% of youths had used a tobacco product in the previous 30 days; 1.6% of youths were daily users. Approximately 40% of tobacco users, adults and youths alike, used multiple tobacco products; cigarettes plus e-cigarettes was the most common combination. Young adults (18 to 24 years of age), male adults and youths, members of racial minorities, and members of sexual minorities generally had higher use of tobacco than their counterparts. CONCLUSIONS: During this study, 28% of U.S. adults were current users of tobacco, and 9% of youths had used tobacco in the previous 30 days. Use of multiple products was common among tobacco users. These findings will serve as baseline data to examine between-person differences and within-person changes over time in the use of tobacco products. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration.).

Child-resistant and tamper-resistant packaging: A systematic review to inform tobacco packaging regulation.

OBJECTIVE: We aimed to investigate the effects of special packaging (child-resistant, adult-friendly) and tamper-resistant packaging on health and behavioral outcomes in order to identify research gaps and implications for packaging standards for tobacco products. METHODS: We searched seven databases for keywords related to special and tamper-resistant packaging, consulted experts, and reviewed citations of potentially relevant studies. 733 unique papers were identified. Two coders independently screened each title and abstract for eligibility. They then reviewed the full text of the remaining papers for a second round of eligibility screening. Included studies investigated a causal relationship between type of packaging or packaging regulation and behavioral or health outcomes and had a study population composed of consumers. Studies were excluded on the basis of publication type, if they were not peer-reviewed, and if they had low external validity. Two reviewers independently coded each paper for study and methodological characteristics and limitations. Discrepancies were discussed and resolved. RESULTS: The review included eight studies: four assessing people's ability to access the contents of different packaging types and four evaluating the impact of packaging requirements on health-related outcomes. Child-resistant packaging was generally more difficult to open than non-child-resistant packaging. Child-resistant packaging requirements have been associated with reductions in child mortality. CONCLUSIONS: Child-resistant packaging holds the expectation to reduce tobacco product poisonings among children under six.

Design and methods of the Population Assessment of Tobacco and Health (PATH) Study.

BACKGROUND: This paper describes the methods and conceptual framework for Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study data collection. The National Institutes of Health, through the National Institute on Drug Abuse, is partnering with the Food and Drug Administration's (FDA) Center for Tobacco Products to conduct the PATH Study under a contract with Westat. METHODS: The PATH Study is a nationally representative, longitudinal cohort study of 45 971 adults and youth in the USA, aged 12 years and older. Wave 1 was conducted from 12 September 2013 to 15 December 2014 using Audio Computer-Assisted Self-Interviewing to collect information on tobacco-use patterns, risk perceptions and attitudes towards current and newly emerging tobacco products, tobacco initiation, cessation, relapse behaviours and health outcomes. The PATH Study's design allows for the longitudinal assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse and transitions between products, as well as factors associated with use patterns. Additionally, the PATH Study collects biospecimens from consenting adults aged 18 years and older and measures biomarkers of exposure and potential harm related to tobacco use. CONCLUSIONS: The cumulative, population-based data generated over time by the PATH Study will contribute to the evidence base to inform FDA's regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation's burden of tobacco-related death and disease.

Tobacco use transitions in the United States: The National Longitudinal Study of Adolescent Health.

OBJECTIVES: The purpose of this study is to evaluate and describe transitions in cigarette and smokeless tobacco (ST) use, including dual use, prospectively from adolescence into young adulthood. METHODS: The current study utilizes four waves of the National Longitudinal Study of Adolescent Health (Add Health) to examine patterns of cigarette and ST use (within 30 days of survey) over time among a cohort in the United States beginning in 7th-12th grade (1995) into young adulthood (2008-2009). Transition probabilities were estimated using Markov modeling. RESULTS: Among the cohort (N=20,774), 48.7% reported using cigarettes, 12.8% reported using ST, and 7.2% reported dual use (cigarettes and ST in the same wave) in at least one wave. In general, the risk for transitioning between cigarettes and ST was higher for males and those who were older. Dual users exhibited a high probability (81%) of continuing dual use over time. CONCLUSIONS: Findings suggest that adolescents who use multiple tobacco products are likely to continue such use as they move into young adulthood. When addressing tobacco use among adolescents and young adults, multiple forms of tobacco use should be considered.

Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products.

The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation.

Converging research needs across framework convention on tobacco control articles: making research relevant to global tobacco control practice and policy.

Much of the research used to support the ratification of the WHO Framework Convention on Tobacco Control (FCTC) was conducted in high-income countries or in highly controlled environments. Therefore, for the global tobacco control community to make informed decisions that will continue to effectively inform policy implementation, it is critical that the tobacco control community, policy makers, and funders have updated information on the state of the science as it pertains to provisions of the FCTC. Following the National Cancer Institute's process model used in identifying the research needs of the U.S. Food and Drug Administration's relatively new tobacco law, a core team of scientists from the Society for Research on Nicotine and Tobacco identified and commissioned internationally recognized scientific experts on the topics covered within the FCTC. These experts analyzed the relevant sections of the FCTC and identified critical gaps in research that is needed to inform policy and practice requirements of the FCTC. This paper summarizes the process and the common themes from the experts' recommendations about the research and related infrastructural needs. Research priorities in common across Articles include improving surveillance, fostering research communication/collaboration across organizations and across countries, and tracking tobacco industry activities. In addition, expanding research relevant to low- and middle-income countries (LMIC), was also identified as a priority, including identification of what existing research findings are transferable, what new country-specific data are needed, and the infrastructure needed to implement and disseminate research so as to inform policy in LMIC.

Portrayal of smokeless tobacco in YouTube videos.

OBJECTIVES: Videos of smokeless tobacco (ST) on YouTube are abundant and easily accessible, yet no studies have examined the content of ST videos. This study assesses the overall portrayal, genre, and messages of ST YouTube videos. METHODS: In August 2010, researchers identified the top 20 search results on YouTube by "relevance" and "view count" for the following search terms: "ST," "chewing tobacco," "snus," and "Skoal." After eliminating videos that were not about ST (n = 26), non-English (n = 14), or duplicate (n = 42), a final sample of 78 unique videos was coded for overall portrayal, genre, and various content measures. RESULTS: Among the 78 unique videos, 15.4% were anti-ST, while 74.4% were pro-ST. Researchers were unable to determine the portrayal of ST in the remaining 10.3% of videos because they involved excessive or "sensationalized" use of the ST, which could be interpreted either positively or negatively, depending on the viewer. The most common ST genre was positive video diaries (or "vlogs"), which made up almost one third of the videos (29.5%), followed by promotional advertisements (20.5%) and anti-ST public service announcements (12.8%). While YouTube is intended for user-generated content, 23.1% of the videos were created by professional organizations. CONCLUSIONS: These results demonstrate that ST videos on YouTube are overwhelmingly pro-ST. More research is needed to determine who is viewing these ST YouTube videos and how they may affect people's knowledge, attitudes, and behaviors regarding ST use.

Research priorities and infrastructure needs of the Family Smoking Prevention and Tobacco Control Act: science to inform FDA policy.

INTRODUCTION: A new law in the United States gives the Food and Drug Administration (FDA) wide latitude to regulate tobacco products for the first time. Given the need for science to serve as a foundation for FDA actions, it is critical that a scientific review of the literature relevant to the proposed legislation be undertaken by experts in the field of nicotine and tobacco research in order to develop research priorities. METHODS: This paper describes an initiative that was implemented to identify research opportunities under "The Family Smoking Prevention and Tobacco Control Act" and summarizes the conclusions and future directions derived from that initiative. RESULTS: Multiple research and surveillance needs were identified, such as characterization of biomarkers and increased analysis of risk perception. It was also recognized that science will play a critical role in policy determinations such as what constitutes "substantial equivalence" and that there will be considerable infrastructure needs (e.g., laboratories for product testing). CONCLUSIONS: Science must drive FDA's decision making regarding tobacco regulation. This article provides a summary of research opportunities identified through literature reviews related to various provisions of the new law. However, the science required by the law requires a transdisciplinary approach because of its complexity, so one of the challenges facing the FDA will be to connect the silos of research in recognition that the "system" of tobacco regulation is greater than the sum of its parts.

Standing on the threshold of change.

Tobacco use remains the nation's leading cause of preventable premature mortality. Lung cancer, one of the many cancers caused by tobacco use, is both the leading cause of cancer death in the United States and the leading cause of male cancer death globally. This special issue of Risk Analysis features the work of the National Cancer Institute's Cancer Intervention and Surveillance Modeling Network (CISNET), which finds that changes in Americans' smoking behaviors that began in the mid 1950s averted nearly 800,000 U.S. lung cancer deaths in the period 1975-2000 alone. However, this figure represents only about 30% of the lung cancer deaths that could potentially have been averted during this period. Despite dramatic declines in smoking prevalence since the mid 1960s, tobacco use is still far too common; today about one in five American adults smokes cigarettes. The tobacco industry's role in promoting tobacco use is now well documented and, as noted by the President's Cancer Panel, "can no more be ignored in seeking solutions to the tobacco problem than mosquitoes can be ignored in seeking to eradicate malaria." Recent developments, including the passage of legislation granting the Food and Drug Administration broad authority to regulate tobacco products, and the entry into force of the Framework Convention on Tobacco Control, an evidence-based treaty developed by the World Health Organization, hold great promise to more swiftly end the epidemic of lung cancer and other tobacco-caused diseases that exacts such a heavy toll in human suffering in the United States and around the world.

YouTube as a source of quitting smoking information.

OBJECTIVE: To conduct analyses to determine the extent to which YouTube videos posted specific to smoking cessation were actually about quitting smoking and if so, whether or not they portrayed evidence-based practices (EBPs). METHODS: In August 2008, researchers identified YouTube videos by search strategies, 'relevance' and 'view count' using the following three search terms: 'stop smoking', 'quit smoking' and 'smoking cessation (n=296 for full sample and n=191 for unique videos). RESULTS: Overall, almost 60% of videos contained a message about quitting smoking. Differences were found across search terms for videos about quitting smoking, with 'stop smoking' yielding the highest percentage (80.8%) of videos about quitting smoking. Almost half of the videos (48.9%) contained EBPs for cessation strategies; however, a significant portion contained either non--EBPs (28.4%) or both EBPs and non-EBPs (22.7%). The number of views per an individual video across the six categories ranged from a low of 8 in the 'relevance' strategy and 'smoking cessation' search term to a high of 1,247,540 in the 'view count' strategy and 'stop smoking' search term. Of the top three most viewed videos by strategy and search term, 66.7% included a specific mention of quitting smoking and, of these, the majority included EBPs. CONCLUSION: Results highlight the need to develop and upload videos containing EBPs both to increase the overall proportion of EBP videos in all categories, particularly in 'quit smoking' and 'stop smoking.' Research is needed to study whether YouTube videos influence knowledge, attitudes and behaviours regarding quitting smoking.

Nicotine reduction revisited: science and future directions.

Regulation of nicotine levels in cigarettes and other tobacco products is now possible with the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009, giving the US Food and Drug Administration (FDA) authority to regulate tobacco products, and with Articles 9-11 of the WHO Framework Convention on Tobacco Control. Both regulatory approaches allow establishing product standards for tobacco constituents, including nicotine. The FSPTCA does not allow nicotine levels to be decreased to zero, although the FDA has the authority to reduce nicotine yields to very low, presumably non-addicting levels. The proposal to reduce levels of nicotine to a level that is non-addicting was originally suggested in 1994. Reduction of nicotine in tobacco products could potentially have a profound impact on reducing tobacco-related morbidity and mortality. To examine this issue, two meetings were convened in the US with non-tobacco-industry scientists of varied disciplines, tobacco control policymakers and representatives of government agencies. This article provides an overview of the current science in the area of reduced nicotine content cigarettes and key conclusions and recommendations for research and policy that emerged from the deliberations of the meeting members.

Using the National Health Interview Survey to understand and address the impact of tobacco in the United States: past perspectives and future considerations.

OBJECTIVE: The National Health Interview Survey (NHIS) is a continuous, nationwide, household interview survey of the civilian noninstitutionalized population of the United States. This annual survey is conducted by the National Center for Health Statistics, part of the Centers for Disease Control and Prevention. Since 1965, the survey and its supplements have provided data on issues related to the use of cigarettes and other tobacco products. This paper describes the survey, provides an overview of peer-reviewed and government-issued research that uses tobacco-related data from the NHIS, and suggests additional areas for exploration and directions for future research. DATA SOURCES: We performed literature searches using the PubMed database, selecting articles from 1966 to 2008. Study selection. Inclusion criteria were relevancy to tobacco research and primary use of NHIS data; 117 articles met these criteria. Data extraction and synthesis. Tobacco-related data from the NHIS have been used to analyze smoking prevalence and trends; attitudes, knowledge, and beliefs; initiation; cessation and advice to quit; health care practices; health consequences; secondhand smoke exposure; and use of smokeless tobacco. To date, use of these data has had broad application; however, great potential still exists for additional use. CONCLUSION: NHIS data provide information that can be useful to both practitioners and researchers. It is important to explore new and creative ways to best use these data and to address the full range of salient tobacco-related topics. Doing so will better inform future tobacco control research and programs.

Use of other tobacco products among U.S. adult cigarette smokers: prevalence, trends and correlates.

This paper examines the trends in concurrent use of cigarettes and other tobacco and sociodemographic variables associated with concurrent use among adult cigarette smokers in the United States. Data from the 1995/96, 1998, 2000, and 2001/02 Tobacco Use Supplements to the Current Population Survey were used to estimate concurrent use of tobacco among cigarette smokers among adults ages 18 years and older (n for all 4 survey groups=552,804). Concurrent use of tobacco fluctuated over the survey periods for current smokers and ranged from 3.7% in 1995/96 to 7.9% in 1998. Results from the multivariate logistic regression indicate that male current, daily, and intermittent smokers had substantially higher odds of concurrent use (OR=12.9, 11.7, 17.2, respectively) than their female counterparts. Age, race/ethnicity, geographic region, income, and survey years were significantly associated with concurrent use among current and daily smokers; for intermittent smokers, these variables and occupation were significantly associated with concurrent use. The strongest correlates for multiple tobacco use among cigarettes smokers were being male and Non-Hispanic White. These factors should be considered when planning tobacco prevention and control efforts. In addition, surveillance efforts should continue to monitor changes in concurrent use and further investigate the increased risk of cancer among smokers who also use other forms of tobacco.

The future of tobacco-control research.

Recent epidemiologic data on the stabilization of adult and youth smoking rates underscore the need for vigorous research across the cancer control spectrum on tobacco use interventions. The steady decline in adult rates of smoking has stalled for the first time in 8 years, and certain race, ethnic, and population groups are disproportionately at risk to tobacco-related cancers because of disparities in tobacco use or access to effective interventions. Although substantial progress has been made across levels of basic through applied research, tobacco-control research across the discovery and delivery continuum must be accelerated to further reduce the cancer burden. Following a brief review of the prevalence and trends affecting tobacco use initiation and cessation, we identify and describe four domains of extraordinary research opportunities: genetics and gene-environment interactions, bioinformatics and health informatics, disparities and disproportionate risk, and prevention and treatment. Evolutionary scientific changes, like rapidly advancing technology and emphasis on the paradigm of team science research approaches, provide both a challenge as well as unparalleled opportunities for scientific advancement and public health progress.

Quit attempts and intention to quit cigarette smoking among young adults in the United States.

OBJECTIVES: We investigated variables associated with quitting behaviors among current, daily, and nondaily young adult smokers in the United States. METHODS: Data from the national 2003 Tobacco Use Special Cessation Supplement to the Current Population Survey were analyzed to identify factors associated with quit attempts and serious intention to quit among young adult smokers aged 18 to 30 years (n=7912). RESULTS: Daily smokers who smoked 20 or more cigarettes per day, had their first cigarette within 30 minutes of waking, and smoked no usual type were less likely than were their comparison groups to have 1 more or quit attempts. Nondaily smokers who were male, Hispanic, and smoked no usual type of cigarette were also less likely than were their comparison groups to report 1 or more quit attempts. Although unemployed nondaily smokers were more likely than were the employed to report intention to quit, nondaily smokers with an annual family income of $25,000 to $49,000 were less likely than were higher-income families to report intention to quit. CONCLUSIONS: Nicotine dependence measures were significantly associated with quitting and intention to quit among daily smokers, but sociodemographics were associated with quitting and intention to quit among nondaily smokers.

Impact of national ABC promotion on 1-800-QUIT-NOW.

PURPOSE: ABC's World News Tonight (WNT) promotion of 800-QUIT-NOW allowed for a nationwide introduction of the QUIT-NOW number; this study examined the impact on call volume. DESIGN: Pre-postassessment. SETTING: National health promotion campaign. SUBJECTS: U.S. population (smokers). MEASURES: Monthly call attempts to the quitline at national and state levels. INTERVENTION: During November 2005 ABC's WNT highlighted the National Network of Tobacco Cessation Quitlines' toll-free number, 800-QUIT-NOW, during the month-long series, "Quit to Live: Fighting Lung Cancer." ANALYSIS: We compared changes in call volume prepromotion, during promotion, and postpromotion by percent and regional differences, range, and average number of calls. RESULTS: Overall call volume in the United States (49 states and the District of Columbia) increased markedly in November; 37,049 calls compared with 16,145 in October. Although there was large variability across states, there was an average of 317 calls prepromotion, 726 calls during the promotion, and 397 calls postpromotion. CONCLUSION: The promotion highlighted the need for capacity building in terms of both sustained promotion and ability of quitlines to provide service as the number of calls increased, as well as the importance of coordinating efforts so adjustments to individual state quitlines can be made. The series served as the first national promotion and drew attention to the potential impact on the National Network of Tobacco Cessation Quitlines.

The FDA "Deeming Rule" and Tobacco Regulatory Research.

In May 2016, the Food and Drug Administration extended its tobacco regulatory authorities to other products meeting the definition of a tobacco product (Deeming Rule). This authority now includes, but is not limited to, electronic nicotine delivery systems (ENDS), such as electronic cigarettes, as well as all cigars, pipes, and hookahs (waterpipes). The FDA's Center for Tobacco Products has been able to fund research projects addressing these newly deemed tobacco products through a variety of mechanisms, including partnership with the Tobacco Regulatory Science Program, National Institutes of Health. In building the evidence base to inform the regulation of and communications about new and emerging tobacco products, it is important for investigators to be mindful of the goals of tobacco regulatory science, ie, scientific inquiry specifically to inform potential regulatory decisions and actions to protect the public's health. Having solid scientific evidence will allow the FDA to make the most appropriate regulatory decisions regarding newly deemed products.

Better practices for youth tobacco cessation: evidence of review panel.

OBJECTIVES: To offer programmers, policy makers, and researchers a scientific basis for developing and selecting smoking cessation treatments for adolescents. METHODS: An evidence review panel systematically rated published and unpublished reports of cessation treatments for youth to make recommendations on theoretical foundations, delivery settings, types of intervention, and provider type. RESULTS: Twenty studies had sufficient validity to inform the recommendations. The 9 studies that reported treatments that increased cessation were based on social cognitive theory. CONCLUSIONS: Cognitive-behavioral interventions are a promising approach for helping young smokers quit smoking. Evidence is insufficient to draw other conclusions at this time.

Recommendations and guidance for practice in youth tobacco cessation.

OBJECTIVE: To summarize recommendations from Youth Tobacco Cessation: A Guide for Making Informed Decisions for careful consideration, selection, implementation, and evaluation of youth cessation interventions. METHODS: Recommendations were developed from an evidence review and consensus from a multidisciplinary advisory panel. RESULTS: Identified essential elements for selecting, planning, delivering, and evaluating youth cessation interventions. CONCLUSIONS: Until there is more evidence for effectiveness of youth specific cessation interventions, clinicians and practitoners should adopt treatments that use cognitive-behavioral approaches for youth cessation interventions that require careful planning and rigorous evaluation.

Improving the future of youth smoking cessation.

OBJECTIVES: To provide recommendations that will build a better foundation for research on youth smoking cessation. METHODS: The Youth Tobacco Collaborative Cessation panel evaluated youth tobacco cessation literature and convened meetings to reach consensus. RESULTS: Methodological issues include design, recruitment and retention, follow-up, measurement, and youth vernacular. Research gaps include youth characteristics, theoretical approaches, delivery settings, and type of provider. Thirteen key research components for reporting are addressed. CONCLUSIONS: Given the dearth of studies on youth smoking cessation, scientifically rigorous studies need to be conducted with attention to methodological issues, research gaps, and reporting of key research components.