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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 Administration9s (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 Study9s 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 FDA9s regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation9s burden of tobacco-related death and disease.

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.

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.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.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.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.

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.

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.

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.

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.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.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.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.

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 9stop 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.

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.

A variety of methods is used to classify research conducted or funded by the National Institutes of Health (NIH). We undertook this analysis to delineate research funded by the National Cancer Institute (NCI) that specifically addresses a tobacco-related research question. Intramural projects, extramural grants, and contracts were coded according to eight categories based on information in the abstracts. One category, "research area," classified projects by the primary study outcome. A total of 318 projects met our inclusion criterion of addressing a tobacco-related research question. As a result, our estimate of about US$107 million in tobacco research during the 2003 fiscal year is different from what is officially reported by NCI. The greatest proportion of tobacco research dollars was devoted to policy research (20%, n = 47) and research on the determinants of tobacco use (19%, n = 36). The greatest number of studies focused on investigating the consequences of tobacco use (32%, n = 105). A substantial number of projects addressed a tobacco-related question specifically about women (n = 45) or a racial/ethnic group (n = 99) and used cigarettes as the primary tobacco product (n = 277). These findings elucidate key areas for future tobacco control research and may help to determine future funding priorities at NCI and in the research community at large. Although tobacco causes nearly 30% of all cancer deaths, NCI spent 2.3% of its total fiscal year 2003 budget on tobacco-related research funding.

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.

Most tobacco control programs focus on prevention for children or cessation for adults. Little is known about cigarette smoking among young adults. This study examined sociodemographic variables associated with current, daily, heavy, and light smoking among young adults in the United States. Data from the 1998-1999 Tobacco Use Supplement to the Current Population Survey (TUS-CPS) were used to examine cigarette smoking patterns and correlates of smoking among 15,371 young adults aged 18-24 years. We found that 26% of young adults were current smokers, 20% were daily smokers, and 8% were former smokers. Current smoking rates were higher among American Indians/Alaska Natives (33%) and Whites (31%) than among other racial/ethnic groups. Compared with white-collar workers, blue-collar and service workers were more likely to report current and daily smoking. Blue-collar workers also were more likely to report heavy smoking (OR = 1.97). The unemployed (those in the labor force but not currently working) and those reporting an annual household income of less than US$20,000 were more likely to report current, daily, and heavy smoking, compared with those not in the labor force and those reporting an annual household income of $20,000 or more, respectively. Young adults not currently enrolled in school were more than twice as likely to report current (OR = 2.36) and daily (OR = 2.90) smoking, compared with those currently enrolled in school. Differential cigarette smoking patterns by race/ethnicity, occupation, employment status, household income, and school enrollment status should be considered when developing interventions to reduce smoking among young adults.

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.

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.

Background: This research analyzed needlestick injuries sustained by employees working in the home health environment to determine to what extent existing infection control policies and procedures in home health care are effective in reducing the risk of transmission of blood-borne infections. Methods: In June and July 1992, a random sample of 600 directors of home health care agencies in the United States were sent questionnaires concerning written blood-borne infection control policies and procedures of home health care agencies. Agency characteristics were also identified. Results: A 46% response rate ( n = 278) was obtained. Of the 226 agencies that reported needlestick injury rates, 102 agencies reported no needlestick injuries to home health care agency employees in the "last year" and 124 agencies reported from one to 134 needlestick injuries, for a cumulative total of 475. Statistical analyses revealed that agencies with "safer" sharps containers, "safer" hypodermics, or "safer" access to intravenous administration lines did not have statistically significantly rates of lower needlestick injury than agencies without these "safer" products. Conclusions: This study should be considered exploratory; causal relationships cannot be established. Although written blood-borne infection control policies and procedures do not appear to provide protection to home health care workers from the risk of needlestick injury, limitations in the data exist. Consequently, results should be viewed with caution and additional research is needed.

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.

People often seek and receive cancer information from mass media (including television, radio, print media, and the Internet), and marketing strategies often inform cancer information needs assessment, message development, and channel selection. In this article, we present the discussion of a 2-hour working group convened for a cancer communications workshop held at the 2008 Society of Behavioral Medicine meeting in San Diego, CA. During the session, an interdisciplinary group of investigators discussed the current state of the science for mass media and marketing communication promoting primary and secondary cancer prevention. We discussed current research, new research areas, methodologies and theories needed to move the field forward, and critical areas and disciplines for future research.

This paper examines factors associated with high levels of recruitment and retention of youth into smoking cessation interventions. Fifty-five articles published from 1976 to June 2004 reported cessation outcomes were analyzed to examine the associations between selected variables and recruitment and retention rates. Studies with participants who smokedor =5 cigarettes per day (cpd) were more likely to have recruitment ratesor =85%. Yet, studies with participants who smokedor =6 cpd were more likely to have high retention rates. Studies that did not use incentives were more likely to have retention rates at end of interventionor =85%. Findings indicate a lack of information reported about recruitment and retention procedures in adolescent tobacco cessation studies. Additional analyses and research need to be conducted to identify successful methods.

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.

OBJECTIVES To describe the formation of the Youth Tobacco Cessation Collaborative (YTCC), a voluntary collaborative of leading funders of youth tobacco cessation research and services. METHODS The long-term goal and specific short-term (2-year) goals, strategies, and accomplishments are briefly described with reference to its guiding action plan: National Blueprint for Action: Youth and Young Adult Tobacco-Use Cessation. RESULTS Aiming to accelerate the pace of discovery and application, YTCC efforts have created a strategic vision for making progress toward filling key knowledge and intervention gaps. CONCLUSIONS Lessons learned about effective partnership are reviewed, and future directions are described.

The National Tobacco Cessation Collaborative identified six core strategies as part of its Consumer Demand Roundtable with the overarching goal of increasing the demand, reach, and use of evidence-based cessation treatments.1 Two of the six core strategies are especially relevant to the paper by Abroms and her colleagues2 in this issue of the American Journal of Preventive Medicine: (1) redesigning evidence-based products and services to better meet consumers’ needs and wants, and (2) marketing and promoting cessation products and services in ways that reach smokers. Emerging technologies such as smart phones may offer a resourceful means to achieve these strategies by providing smoking cessation services via a mobile platform that allows engagement of smokers in real time wherever smokers are.

OBJECTIVE To examine how science is advancing in order to address adolescent tobacco use cessation. METHODS Review of the published scientific literature from 1995 to September 2000 and National Cancer Institute youth tobacco cessation research portfolio. RESULTS Because of methodological limitations, results of behavioral interventions are inconclusive. Two studies have been published evaluating the nicotine patch for adolescent smoking cessation, though neither employed a randomized, placebo-control design. Both of these studies found the nicotine patch to be ineffective. CONCLUSIONS Although much is known about youth tobacco use, additional research is needed to find answers to best help youth to quit smoking.

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 U.S. Food and Drug Administration authority to regulate tobacco products, and with Articles 9-11 of the World Health Organization Framework Convention on Tobacco Control.[1-2] 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 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.[3] 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 United States with non-tobacco-industry scientists of varied disciplines, tobacco control policy-makers 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.

To summarise the evidence on adolescent and young adult prevention and cessation, and provide future directions for research.Data were collected from published literature. Searches for adolescent prevention were conducted using PubMed, PsycInfo, and ERIC; and for cessation, PubMed, and two major reviews that span January 1978 to May 2002. PubMed, PsychInfo, and SCCI were searched for young adults from January 1990 to May 2002.Data included smoking prevention studies published from January 1990 to May 2002 and conducted in the USA; all identified smoking cessation studies for adolescents. Young adult data were limited to initiation and cessation studies.Extraction of data was by consensus of the authors.Results of the review are qualitative in nature using a consensus approach of the authors.School based curricula alone have been generally ineffective in the long term in preventing adolescents from initiating tobacco use but are effective when combined with other approaches such as media and smoke-free policies. Prevention research should consider multiple approaches and the social conditions that influence the development of youth problem behaviours including tobacco use. Because youth smoking cessation has been understudied to date, scientifically rigorous adolescent smoking cessation studies need to be conducted with attention to high risk smokers and less than daily smokers. Tobacco prevention and cessation for young adults needs focused attention. Prevention and cessation programmes need to address other tobacco products in addition to cigarettes.

Although cigarette smoking has declined for the U.S. adult population overall in the last 20 years, the use of smokeless tobacco products has been increasing at an alarming rate, especially among male adolescents and certain special population groups. It is estimated that there are currently more than 12 million users of smokeless tobacco in the United States (about 6 million people use smokeless tobacco weekly or more often), with 3 million of these users under 21 years of age. The evidence of health-related effects from the use of smokeless products is strongest for oral cancer. The excess risk of cancer of the cheek and gum may reach nearly 50-fold among certain groups of long-term users.