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.

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.

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.

Symptoms of tobacco dependence among middle and high school tobacco users: results from the 2012 National Youth Tobacco Survey.

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.

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.

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.

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.

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.

National patterns and correlates of mentholated cigarette use in the United States.

AIM: To examine the patterns and correlates of mentholated cigarette smoking among adult smokers in the United States. DESIGN: Cross-sectional data on adult current smokers (n = 63,193) were pooled from the 2003 and 2006/07 Tobacco Use Supplements to the Current Population Survey. MEASUREMENTS: The associations between socio-demographic and smoking variables were examined with gender- and race/ethnicity-stratified multivariate logistic regression models predicting current use of mentholated cigarettes. FINDINGS: Multivariate logistic regression analyses demonstrated that black smokers were 10-11 times more likely to smoke mentholated cigarettes than white smokers men: odds ratio (OR): 11.59, 99% confidence interval (CI): 9.79-13.72; women: OR: 10.12, 99% CI: 8.45-12.11). With the exception of American Indian/Aleut/Eskimo smokers, non-white smokers were significantly more likely to smoke mentholated cigarettes than were white smokers. Additional significant factors associated with mentholated cigarette smoking included being unmarried (never married: OR: 1.21, 99% CI: 1.09-1.34; divorced/separated: OR: 1.13, 99% CI: 1.03-1.23), being born in a US territory (OR: 2.01, 99% CI: 1.35-3.01), living in a non-metropolitan area (OR: 0.87, 99% CI: 0.80-0.96), being unemployed (OR: 1.24, 99% CI: 1.06-1.44) and lower levels of education. Race/ethnicity-stratified analyses showed that women were more likely than men to smoke mentholated cigarettes. Among black smokers, young adults (aged 18-24 years) were four times more likely to smoke mentholated cigarettes compared with individuals aged 65+. CONCLUSIONS: Race/ethnicity, gender and age are significant correlates of mentholated cigarette smoking among current smokers. Given the importance of menthol in the cigarette market and the potential untoward health effects of this additive, continued surveillance of the prevalence and correlates of mentholated cigarette use among diverse socio-demographic groups is warranted to inform appropriate interventions.

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.

Translational medication development for nicotine addiction.

OBJECTIVE: To review the current state of the science in medication development for nicotine dependence and to identify important areas for future research. METHODS: The National Cancer Institute and the National Institute on Drug Abuse convened a conference focused on translational approaches to the development, evaluation, and delivery of medications for the treatment of tobacco dependence. RESULTS: Future research directions include investigations of the efficacy of novel compounds and new applications for existing medications; pharmacogenetic trials of nicotine dependence treatments; and studies of the molecular, neural, and behavioral mechanisms of action of efficacious medications. CONCLUSIONS: Medication development for the treatment of tobacco dependence remains a scientific and public health priority.