Advice to the European Commission as Regards Type and Criteria for Comprehensive Studies to Be Requested From Manufacturers: The Opinion of the Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER).

The European Commission has established a priority list of 15 additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations. The European Union (EU) Tobacco Products Directive (TPD) prescribes that Member States shall require manufacturers and importers of tobacco products to carry out comprehensive studies on these additives to assess their contribution to any of the properties listed in Article 6 of the TPD: toxicity or addictiveness, characterizing flavor, inhalation facilitation, nicotine uptake, and carcinogenic, mutagenic, or toxic for reproduction. The Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) has provided guidance on the type and criteria for comprehensive studies, and on the most suitable methodologies to test these 15 tobacco additives as well as additives on future updated lists. The SCHEER proposes a stepwise strategy as the most pragmatic and efficient way to assess the effects of tobacco additives. In addition to proposing specific steps and tests to be considered by industry, some general criteria were also identified such as no comparative testing (testing cigarettes with and without the additive) and no animal studies. As tobacco additives have no benefits for health, but rather may promote use of and addiction to an extremely toxic product, a risk-benefit analysis is not the appropriate paradigm for assessing the additive. When comprehensive studies confirm that additives have any of the properties listed in Article 6 of the TPD, regulatory actions should be considered. If uncertainties cannot be solved by comprehensive studies, the SCHEER recommends that the assessors consider the worst-case evaluation. IMPLICATIONS: In this article, the SCHEER proposes a stepwise strategy to assess (1) the toxic and addictive effects, (2) the characterizing flavor, and (3) facilitating inhalation properties of tobacco additives. The proposed steps and tests provide guidance to (1) Member State on which comprehensive studies should be requested and (2) tobacco industry on which strategy of testing should be applied to address the request and to prepare reports to be sent to the relevant authorities for the evaluation of tobacco additives "safety" to comply with the Tobacco Products Directive 2014/40/EU.

Identification of Cigarette Brands by Soft Independent Modeling of Class Analogy of Volatile Substances.

INTRODUCTION: This study aimed to develop a method for discriminating cigarette brands based on the profiles of volatile components extracted from the tobacco fraction of the finished cigarettes to authenticate branded cigarettes of unknown origin. METHODS: An analytical method comprising direct thermal desorption coupled with gas chromatography-quadrupole time-of-flight mass spectrometry was developed for acquiring volatile profiles of cigarettes. About 290 samples of commercially available cigarettes were analyzed. Within this batch, 123 samples represented four popular cigarette brands. They were selected for in-depth characterization. Multivariate analysis was used to investigate the interrelations among volatile compounds of cigarettes and to identify characteristic markers for the cigarette discrimination. Supervised pattern recognition techniques were used for designing classification models. RESULTS: Principal component analysis covering all detected volatiles allowed the differentiation of cigarettes based on the brand. A number of 56 volatile components were identified as markers with high discrimination power. These compounds were used for establishing classification models. A method of soft independent modeling of class analogy developed for the four studied cigarette brands proved to be efficient in the classification of unknown cigarettes, with accuracy between 95.9% and 100%. CONCLUSIONS: The data evaluation by soft independent modeling of class analogy was highly accurate in classification of unknown cigarettes with a low rate of false positives and false negatives. The developed models can be used for discrimination of genuine from non-genuine products with high level of probability. IMPLICATIONS: Profiling of volatiles, which is commonly used for authentication of different food commodities, was applied for the characterization of cigarette tobacco for the purpose of authentication a cigarette brand. Volatile components with a high discrimination power were identified by means of multivariate statistical methods and used for establishing of a classification model. The classification model was able to discriminate genuine from non-genuine cigarettes with a high level of prediction accuracy. This model could be a powerful tool for tobacco control to judge the authenticity of cigarettes.

Associations Between Exposure and Receptivity to Branded Cigarette Advertising and Subsequent Brand Preference Among US Young Adults.

INTRODUCTION: Exposure and receptivity to cigarette advertising are well-established predictors of cigarette use overall. However, less is known about whether exposure and receptivity to advertising for specific brands of cigarettes (ie, Marlboro, Camel, and Newport) are longitudinally associated with any subsequent cigarette use and subsequent use of those specific brands. METHODS: We analyzed data from a US sample of 7325 young adults aged 18-24 years who completed both Wave 1 and Wave 2 of the Population Assessment of Tobacco and Health study. Weighted logistic regression models were used to examine (1) among Wave 1 never-smokers, associations between Wave 1 exposure and receptivity to advertising for Marlboro, Camel, and Newport and subsequent overall and brand-specific smoking initiation at Wave 2, and (2) among Wave 1 ever-smokers, associations between Wave 1 exposure and receptivity to advertising for Marlboro, Camel, and Newport and subsequent preference of those brands at Wave 2. RESULTS: Among Wave 1 young-adult never-smokers, exposure to Camel advertising, but not Marlboro or Newport, was associated with smoking initiation with any brand of cigarettes at Wave 2. Among Wave 1 young-adult ever-smokers, receptivity to Marlboro, Camel, and Newport advertising was associated with subsequent preference for each brand, respectively, at Wave 2. CONCLUSIONS: This study found evidence for the association between receptivity to branded cigarette marketing and subsequent use of that brand. These findings provide evidence regarding the pathways through which cigarette marketing attracts young adults to use cigarettes and can inform tobacco prevention and counter-marketing efforts. IMPLICATIONS: This study extends prior work on the effects of cigarette advertising exposure and receptivity by illustrating the brand specificity of this advertising. These findings provide evidence that receptivity to branded cigarette advertising is longitudinally associated with preference for those specific cigarette brands.

Research on Youth and Young Adult Tobacco Use, 2013-2018, From the Food and Drug Administration-National Institutes of Health Tobacco Centers of Regulatory Science.

The Tobacco Regulatory Science Program is a collaborative research effort between the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). In 2013, the NIH funded 14 Tobacco Centers of Regulatory Science (TCORS), which serve as partners in establishing research, training, and professional development programs to guide FDA. Each of the fourteen TCORS, and two other NIH-funded research programs, the Center for the Evaluation of Nicotine in Cigarettes (CENIC) and the Consortium on Methods Evaluating Tobacco (COMET), pursued specific research themes relevant to FDA's priorities. A key mandate for FDA is to reduce tobacco use among young people. This article is a review of the peer-reviewed research, including published and in-press manuscripts, from the TCORS, CENIC, and COMET, which provides specific data or other findings on youth (ages 10-18 years) and/or young adults (ages 18-34 years), from 2013 to 2018. Citations of all TCORS, CENIC, and COMET articles from September 2013 to December 2017 were collected by the TCORS coordinating center, the Center for Evaluation and Coordination of Training and Research. Additional citations up to April 30, 2018 were requested from the principal investigators. A scoring rubric was developed and implemented to assess study type, primary theme, and FDA priority area addressed by each article. The major subareas and findings from each priority area are presented. There were 766 articles in total, with 258 (34%) focusing on youth and/or young adults. Findings relevant to FDA from this review concern impact analysis, toxicity, health effects, addiction, marketing influences, communications, and behavior. IMPLICATIONS: The Tobacco Centers of Regulatory Science, CENIC, and COMET have had a high output of scientific articles since 2013. These Centers are unique in that the FDA supports science specifically to guide future regulatory actions. The 258 articles that have focused on youth and/or young adults are providing data for regulatory actions by the FDA related to the key priority areas such as the addictiveness of non-cigarette products, the effects of exposure to electronic cigarette marketing on initiation and cessation, and the impact of flavored products on youth and young adult tobacco use. Future regulations to reduce tobacco use will be guided by the cumulative evidence. These Centers are one innovative mechanism to promote important outcomes to advance tobacco regulatory science.

Development and Piloting Testing of an Experimental Tobacco and Nicotine Product Marketplace.

INTRODUCTION: We describe the development and pilot testing of the experimental tobacco and nicotine product marketplace (ETM)-a method for studying tobacco and nicotine product (TNP) choices and use behavior in a standardized way. AIMS AND METHODS: The ETM resembles an online store populated with TNPs. Surveillance activities and data from a US representative survey and consumer reports were used to determine the most popular TNPs for inclusion in the ETM. Standardized information and videos demonstrating how to use the TNPs were provided. To test the feasibility of using the ETM, smokers (n = 119) underwent monitoring of usual brand cigarette smoking and other TNP use (Baseline Phase) followed by access to the ETM (ETM Phase) that included their usual brand cigarettes, e-cigarettes, moist snuff, snus, and nicotine replacement therapy. During the ETM Phase, participants were provided points based on their baseline TNP consumption to exchange for TNPs in the ETM. Participants were advised to exchange points for enough TNPs to last until their next visit and to refrain from using TNPs not obtained in the ETM. A subset of the participants (n = 62) completed a survey on their experience with the ETM. RESULTS: The majority of the participants stated they were comfortable with navigating the ETM (97%), it was easy to determine product characteristics (89%), and they were satisfied with the products included in the marketplace (85%). CONCLUSIONS: The ETM was well received by the vast majority of the participants and can be utilized by researchers to investigate a variety of TNP policy and regulatory science research questions. IMPLICATIONS: Patterns of TNP use are complex due to greater availability, marketing, and promotion of a diverse array of TNPs. Innovative methods are needed to experimentally study TNP choices and patterns. Through describing the development of the ETM, we provide researchers with a tool that can be readily adapted to studying a variety of phenomena challenging public health.

Public Reactions to the Cigarette Control Regulation on a Chinese Microblogging Platform: Empirical Analysis.

BACKGROUND: On January 1, 2019, a new regulation on the control of smoking in public places was officially implemented in Hangzhou, China. On the day of the implementation, a large number of Chinese media reported the contents of the regulation on the microblog platform Weibo, causing a strong response from and heated discussion among netizens. OBJECTIVE: This study aimed to conduct a content and network analysis to examine topics and patterns in the social media response to the new regulation. METHODS: We analyzed all microblogs on Weibo that mentioned and explained the regulation in the first 8 days following the implementation. We conducted a content analysis on these microblogs and used social network visualization and descriptive statistics to identify key users and key microblogs. RESULTS: Of 7924 microblogs, 12.85% (1018/7924) were in support of the smoking control regulation, 84.12% (6666/7924) were neutral, and 1.31% (104/7924) were opposed to the smoking regulation control. For the negative posts, the public had doubts about the intentions of the policy, its implementation, and the regulations on electronic cigarettes. In addition, 1.72% (136/7924) were irrelevant to the smoking regulation control. Among the 1043 users who explicitly expressed their positive or negative attitude toward the policy, a large proportion of users showed supportive attitudes (956/1043, 91.66%). A total of 5 topics and 11 subtopics were identified. CONCLUSIONS: This study used a content and network analysis to examine topics and patterns in the social media response to the new smoking regulation. We found that the number of posts with a positive attitude toward the regulation was considerably higher than that of the posts with a negative attitude toward the regulation. Our findings may assist public health policy makers to better understand the policy's intentions, scope, and potential effects on public interest and support evidence-based public health regulations in the future.

Emissions of Free Radicals, Carbonyls, and Nicotine from the NIDA Standardized Research Electronic Cigarette and Comparison to Similar Commercial Devices.

E-cigarettes (e-cigs) are a diverse and continuously evolving group of products with four generations currently in the market. The National Institute on Drug Abuse (NIDA) standardized research e-cigarette (SREC) is intended to provide researchers with a consistent e-cig device with known characteristics. Thus, we conducted laboratory-based characterizations of oxidants and nicotine in aerosols produced from SREC and other closed-system, breath-activated, commercially available e-cigs (Blu and Vuse). We hypothesized that oxidant and nicotine production will be significantly affected in all devices by changes in puffing parameters. All e-cigs were machine vaped and the aerosols generated were examined for nicotine, carbonyls, and free-radicals while varying the puff-volumes and puff-durations to reflect typical human usage. The data were normalized on a per puff, per gram aerosol, and per milligram nicotine basis. We found that aerosol production generally increased with increasing puff-duration and puff-volume in all e-cigs tested. Increased puff-duration and puff-volume increased nicotine delivery for Blu and Vuse but not the SREC. We report, for the first time, reactive free-radicals in aerosols from all closed-system e-cigs tested, albeit at levels lower than cigarette smoke. Formaldehyde, acetaldehyde, acetone, and propionaldehyde were detected in the aerosols of all tested e-cigs. Carbonyl and free radical production is affected by puff-duration and puff volume. Overall, SREC was more efficient at aerosol and nicotine production than both Blu and Vuse. In terms of carbonyl and free radical levels, SREC delivered lower or similar levels to both other devices.

The Importance of Estimating Causal Effects for Evaluating a Nicotine Standard for Cigarettes.

Recent evidence from randomized clinical trials (RCTs) of very low nicotine content (VLNC) cigarettes indicates that smokers randomized to VLNC cigarettes had significantly lower cigarette use, dependence, and biomarkers of exposure than smokers randomized to normal nicotine content control cigarettes. In these trials, a substantial number of participants did not adhere to their randomized treatment assignment, i.e., they used commercial cigarettes not provided by the trial in place of or in addition to the VLNC cigarettes provided by the trial. As with most RCTs, the analysis of these trials followed the intention-to-treat principle, where participants are analyzed according to their randomized treatment assignment regardless of adherence. Alternately, the analysis of an RCT could focus on the estimation and testing of the causal effect of the intervention, which is the treatment effect if all subjects were to adhere to their randomized treatment assignment. In this commentary, we compare these two approaches, highlighting the important role of causal estimation and inference for evaluating the regulatory effect of a nicotine standard for cigarettes. Additionally, we review the results of the secondary analyses of randomized trials of VLNC cigarettes using causal inference methodology to account for non-adherence to the assigned treatment and discuss the implications for a nicotine standard for cigarettes.

Research on Behavioral Discrimination of Nicotine May Inform FDA Policy on Setting a Maximum Nicotine Content in Cigarettes.

INTRODUCTION: The Food and Drug Administration may set a maximum nicotine content in cigarettes to minimize smoking's addictiveness. Our recent research may indirectly support setting levels applicable to the population of dependent smokers below 1 mg/g (mg nicotine/g of tobacco filler). METHODS: Using a within-subjects design in laboratory-based studies totaling 61 nontreatment seeking adult dependent smokers, Spectrum research cigarettes with nicotine contents ranging from 1.3 to 17 mg/g (just one per session) were compared with the lowest content available, 0.4 mg/g. Identified for each participant was the smallest difference in nicotine content, or "threshold," between cigarettes that still supported behavioral discrimination (ie, ability to objectively distinguish their difference). The next lower nicotine content cigarette, not discriminated (by definition), was labeled their "subthreshold." Subjective perceptions and choice behavior were also assessed. RESULTS: Thresholds varied widely among all 61 smokers but, importantly, fewer than 7% of smokers could discriminate the two lowest, 1.3 versus 0.4 mg/g nicotine, meaning more than 90% could not do so. Moreover, we found a consistent association between their nicotine discrimination threshold and their subjective perceptions and subsequent reinforcement behavior later in the session. Specifically, a participant's discrimination threshold cigarette was also more highly rated and preferred (ie, self-administered), whereas their subthreshold cigarette was rated similarly to the 0.4 mg/g and not preferred. CONCLUSIONS: Cigarette nicotine content below the threshold for perceiving nicotine's effects (ie, its discriminability) in nearly all smokers from a no nicotine comparison is likely below 1.0 mg/g, or less than or equal to 10% of that in typical commercial cigarettes. IMPLICATIONS: Cigarettes with nicotine contents able to be discriminated (threshold) are also reinforcing, and those unable to be discriminated are not reinforcing, as anticipated. Yet, research explicitly comparing cigarettes with contents below 1.0 mg/g versus no nicotine (ie, a "placebo") is needed with larger samples. Results may confirm what nicotine content lower than 1.0 mg/g is below the threshold for discrimination (and self-administration) in the vast majority (>95%) of adult dependent smokers as well as teens beginning to smoke. Identifying that content would strongly support the Food and Drug Administration policy to establish a maximum nicotine content in cigarettes that will not maintain dependence.

Widespread Belief That Organic and Additive-Free Tobacco Products are Less Harmful Than Regular Tobacco Products: Results From the 2017 US Health Information National Trends Survey.

SIGNIFICANCE: US smokers of Natural American Spirit, a brand marketed as "organic" and "additive-free," are more likely than other cigarette smokers to believe that their brand might be less harmful than other brands. This article (1) describes the prevalence of belief that "organic" and "additive-free" tobacco is less harmful than regular tobacco products in the US population and (2) describes the sociodemographic characteristics of adults who believe tobacco products with these descriptors are less harmful. METHODS: Data were drawn from the 2017 Health Information National Trends Survey (HINTS), a nationally representative survey of US adults. Logistic regression models were used to examine correlates of the belief that "organic" or "additive-free" tobacco products are less harmful than regular tobacco products. RESULTS: Overall, 26.7% of US adults and 45.3% of adult smokers believe that "organic" tobacco products are less harmful than regular tobacco products. Similarly, 35.2% of US adults and 47.1% of smokers believe that "additive-free" tobacco products are less harmful. When examining gender, age, education, race/ethnicity, sexual orientation, and smoking status, only age (adjusted odds ratio [aOR] ~0.98, 95% confidence interval [CI]: 0.97, 0.99 for both outcomes) and smoking status (current vs. never smokers, aOR ~1.78, 95% CI 1.03, 3.07 for both outcomes) were correlates of believing that "organic" or "additive-free" tobacco is less harmful than regular tobacco products. CONCLUSIONS: Belief that "organic" and "additive-free" tobacco products are less harmful than other products is widespread. Younger adults and current smokers are most likely to be misinformed by "organic" or "additive-free" tobacco product descriptors. IMPLICATIONS: Belief that "organic" and "additive-free" tobacco products are less harmful than other products is widespread among US adults and most prevalent among smokers. Removal of terms that incorrectly imply reduced harm may correct current and future consumers' misperceptions about the brand.

Advancing Tobacco Product Warning Labels Research Methods and Theory: A Summary of a Grantee Meeting Held by the US National Cancer Institute.

BACKGROUND: The World Health Organization's Framework Convention on Tobacco Control recommends prominent pictorial health warnings on tobacco products. To advance research methods, theory and understanding of how tobacco product warning labels (TPWLs) work, the US National Cancer Institute convened a grantee meeting. Our article describes the key insights that emerged from the meeting, situated within the context of the scientific literature. RESULTS & RECOMMENDATIONS: First, presentations confirmed that large, pictorial TPWLs motivate people to try to quit and encourage smoking cessation. Second, pictorial TPWLs increase attention, knowledge, negative affect, and thinking about the warning. Third, TPWL studies have primarily used brief-exposure laboratory studies and observational studies of sustained exposure through national policy implementation, with a few randomized trials involving several weeks of exposure-with generally consistent results found across study designs. Fourth, novel assessment methods include brain imaging, eye tracking and "best-worst" discrete choice experiments. To make TPWL even more effective, research is needed to confirm the mechanisms of their influence, their impact across vulnerable populations, and their effect on social media posts about tobacco products. Research is also needed on the effect of trial design choices, the predictive validity of new measurement approaches, and warning labels for non-cigarette tobacco products. IMPLICATIONS: To improve scientific understanding of TPWL effects, this grantee meeting summary describes emerging research methods, theory and study results. Directions for future research include examination of the mechanisms of how warning labels work across diverse tobacco products and across different populations and contexts.

Evidence From Qualitative Studies of Youth About the Impacts of Tobacco Control Policy on Young People in Europe: A Systematic Review.

INTRODUCTION: A range of tobacco control policies endeavor to prevent smoking uptake in young people, yet relatively little is known about how such interventions impact young people's engagement with smoking. We reviewed existing qualitative evidence on young people and smoking in Europe to assess whether, in what ways and why young people comply with, adapt to, resist, or circumvent tobacco control policies in their respective countries. METHODS: We undertook a systematic review of academic literature presenting qualitative research from Europe on smoking and young people (11-18 years), published from 2000 to 2015. Bibliographic searches (PubMed, PsycInfo, SSCI) produced 1357 records, from which 43 relevant articles were assessed for quality and 39 included in the review. RESULTS: Most studies were from the United Kingdom (27), with a small number (one or two each) from other European countries (Denmark, Sweden, Switzerland, Belgium, Cyprus, Greece, Hungary, Ireland, and Spain). Only 16 articles (11 from United Kingdom) provided any evidence about the impacts of tobacco control policies on young people's smoking. These focused on smoke-free legislation (four), age of sale laws (four), plain packaging (three), and black market tobacco (one). CONCLUSIONS: There is very little qualitative evidence exploring the impacts of tobacco control on youth smoking in Europe. To develop more effective smoking prevention policies that take account of local political, social, and cultural contexts, more qualitative research from a wider range of European countries is needed to understand how tobacco control impacts on young people's social worlds and smoking behaviors. IMPLICATIONS: Smoking is the leading cause of premature mortality in Europe. However, there is little qualitative evidence exploring the impact of tobacco control policies on young people in Europe. Most comes from the United Kingdom and focuses on a narrow range of policies. Thus, we have a limited understanding of how and in what ways tobacco control policies reach young people, their engagement with these, and how local context affects their impact. More qualitative research is needed, from a wider range of countries and on a broader range of tobacco control policies, to strengthen the evidence-base for reducing youth smoking.

"Organic," "Natural," and "Additive-Free" Cigarettes: Comparing the Effects of Advertising Claims and Disclaimers on Perceptions of Harm.

INTRODUCTION: The US Tobacco Control Act restricts advertising or labeling that suggests one tobacco product is less harmful than another. We sought to examine how "organic," "natural," and "additive-free" advertising claims and corresponding disclaimers affect perceptions of cigarettes' harm. METHODS: Participants were a national probability sample of adults in the United States (n = 1114, including 344 smokers). We conducted a 5 (claim) × 2 (disclaimer) between-subjects factorial experiment. Participants viewed a Natural American Spirit cigarettes ad claiming they were "organic," "natural," "additive-free," "light," or "regular;" and with or without a corresponding disclaimer. The outcome was perceived harm of the advertised cigarettes. Among smokers, we also assessed interest in switching within their current brand to cigarettes with this characteristic (eg, "additive-free"). RESULTS: Claims in the ad had a large effect on perceived harm (Cohen's d = 0.87, 95% CI = 0.47 to 1.29). Claims of cigarettes being "organic," "natural," or "additive-free" reduced perceived harm from the advertised cigarettes, as compared with "regular" and "light" claims. Disclaimers had a small effect, increasing perceived harm (d = 0.25, 95% CI = 0.08 to 0.41). The problematic claims also increased smokers' interest in switching. Disclaimers had no effect on smokers' interest in switching. CONCLUSIONS: "Organic," "natural," and "additive-free" claims may mislead people into thinking that the advertised cigarettes are less harmful than other cigarettes. Disclaimers did not offset misperceptions of harm created by false claims. The US Food and Drug Administration should restrict the use of these misleading claims in tobacco advertising. IMPLICATIONS: "Organic," "natural," and "additive-free" cigarette advertising claims decrease perceptions of harm among the public and increase interest in switching to such cigarettes among smokers. Disclaimers do not counteract the reduced perceptions of harm or increased interest in switching to these cigarettes. The US Food and Drug Administration should restrict the use of "organic," "natural," and "additive-free" claims in tobacco marketing.

Consumer Perceptions of Cigarette Design in France: A Comparison of Regular, Slim, Pink and Plain Cigarettes.

INTRODUCTION: The cigarette, like the cigarette pack, is used by tobacco companies as a promotional tool. We explore how the cigarette could potentially be used as a dissuasive tool. METHODS: An online survey was conducted with 15-30-year-old smokers and nonsmokers (N = 998) in France to explore their perceptions of a plain cigarette (gray with no brand name) and three branded cigarettes (regular, slim, pink). Participants were randomly assigned to view the plain cigarette and either the regular, slim, or pink cigarette. They were asked to rate the cigarettes by Appeal (tastiest, highest quality, and most expensive), Harm (most dangerous and most effective for motivating people to talk about tobacco dangers), and Perceived behavioral impact (most effective to convince teenagers not to start and to motivate smokers to reduce consumption and quit). RESULTS: In comparison to the gray cigarette, each of the branded cigarettes were considered more appealing, less harmful, and more likely to motivate teenagers to start and less likely to motivate smokers to reduce consumption or quit. CONCLUSIONS: The study suggests that altering the appearance of the cigarette may reduce cigarette appeal, increase harm perceptions, and deter both young people and smokers. IMPLICATIONS: Very little research has focused on dissuasive cigarettes whereas the cigarette stick has become very important for tobacco companies for communication purposes. This is the first study to compare the effect of various branded cigarettes (regular, slim, and pink) with a plain gray cigarette on young adult smokers and nonsmokers. The findings suggest that a plain gray cigarette can reduce cigarette appeal, increase perceptions of harm, and may deter use among both smokers and nonsmokers.

Introduction of Standardized Tobacco Packaging During a 12-Month Transition Period: Findings From Small Retailers in the United Kingdom.

INTRODUCTION: Factory-made cigarettes (FMC) and roll-your-own (RYO) tobacco have had to be produced in standardized packaging since May 20, 2016 in the United Kingdom, with a minimum pack size of 20 sticks for FMC and 30 g for RYO. Manufacturers and retailers were given a 12-month transition period. METHODS: An observational study was conducted using monthly Electronic Point of Sale data from 500 small retailers in England, Scotland, and Wales, between May 2016 and May 2017. The 20 top selling tobacco products (15 FMC, 5 RYO) were monitored to observe when standardized packs were first introduced, the proportion of retailers selling each fully branded and standardized product, and the average number of monitored fully branded and standardized products sold by each retailer. The number of unique tobacco-related product codes sold by each retailer was also recorded each month. RESULTS: Eighteen of the fully branded products continued to be sold throughout the transition period and no standardized variants were sold in the first 5 months. It was not until month eleven that the average number of standardized products sold by retailers exceeded the fully branded products. The average number of unique tobacco-related product codes sold by each retailer decreased by a third over the transition period. CONCLUSIONS: Tobacco companies used the transition period to delay the removal of fully branded products and gradually introduce standardized variants. This staggered introduction may have mitigated some of the immediate intended effects of the legislation by desensitizing consumers to new pack designs. IMPLICATIONS: Evaluation research from countries which have introduced standardized packaging for tobacco products is key to help inform future implementation. This is the first study to monitor the transition from fully branded to standardized products using real-time retail data. The findings demonstrate that tobacco companies delayed the introduction of standardized products and removal of fully branded packaging. Countries seeking to introduce standardized packaging should consider what length of transition is allowed, as the protracted 12-month period in the United Kingdom appeared longer than needed to transition stockholding and may have mitigated immediate intended effects by desensitizing consumers to new pack designs.

The price elasticity of quantity, and of quality, for tobacco products.

We use household survey data to estimate the price elasticity of quantity, and of quality, for tobacco products. In our data, commonly used estimation methods suggest an own-price elasticity of demand of about -1. These methods add together responses on the quantity margin and the quality margin. Just one third of the response to price is from quantity and two thirds is from quality. The simulated effect of higher excise taxes is to reduce overall quantity by just one third of what is predicted if the quality response is ignored. Higher taxes also shift demand to lower quality tobacco products.

Association of flavoured cigar regulations with wholesale tobacco volumes in Canada: an interrupted time series analysis.

INTRODUCTION: This study examines the association of Federal Canadian regulations passed in 2009 addressing flavours (excluding menthol) in small cigars with changes in cigar sales. METHODS: Quarterly wholesale unit data as reported to Health Canada from 2001 through 2016 were analysed using interrupted time series analysis. Changes in sales of cigars with and without flavour descriptors were estimated. Analyses were seasonally adjusted. Changes in the flavour types were assessed over time. RESULTS: The Federal flavour regulations were associated with a reduction in the sales of flavoured cigars by 59 million units (95% CI -86.0 to -32.4). Increases in sales of cigars with descriptors other than flavours (eg, colour or other ambiguous terms) were observed (9.6 million increase (95% CI -1.3 to 20.5), but the overall level (decline of 49.6 million units (95% CI -73.5 to -25.8) and trend of sales of cigars (6.9 million units per quarter (95% CI -8.1 to -5.7)) declined following the ban. Sensitivity analysis showed that there was no substantial difference in effect over time comparing Ontario and British Columbia, suggesting that other provincial tobacco control legislation was not associated with the changes in levels. Analyses suggested that the level change was sensitive to the specification of the date. CONCLUSION: This study demonstrates that flavour regulations have the potential to substantially impact tobacco sales. However, exemptions for certain flavours and product types may have reduced the effectiveness of the ban, indicating the need for comprehensive, well-designed regulations.

Innovations in counterfeiting tax stamps: a study of ultraviolet watermarks in a sample of discarded New York City packs.

OBJECTIVE: Document the use of ultraviolet watermark in counterfeit joint New York City/New York State cigarette tax stamps to assess the scale at which distributors of illegal cigarettes adapt to measures protecting the integrity of the system of tobacco tax collection. METHODS: In 2016, we collected 2357 empty discarded cigarette packs along a stratified random sample of block groups in New York City (n=114) and analysed 449 joint New York City/New York State tax stamps using long wave ultraviolet irradiation, light microscopy and taggant testers developed by the tax stamp manufacturer, Meyercord Revenue, to determine whether the tax stamps were counterfeit and how they differed from their genuine equivalent. FINDINGS: 23% (n=102) of the joint NYC/NYS tax stamps examined were counterfeit. Subsequent investigation revealed that almost two-thirds (n=58) of the counterfeit sample bore ultraviolet watermark that closely resembled genuine tax stamps in terms of fluorescence, watermark colour and wording. However, microscopic findings revealed that counterfeit tax stamps mismatched the genuine ultraviolet watermark in regards to font style and word orientation. CONCLUSION: Counterfeiters are using ultraviolet watermarks which makes it difficult to differentiate counterfeit joint New York City/New York State tax stamps from their genuine equivalent when UV irradiation is used as the sole screening tool. Innovations in counterfeiting technology may be the result of fluorescent ink being available for purchase in the mainstream market. Independent monitoring of trends in the illicit market for tobacco products is advised to keep apace of counterfeiting methods.

Difference between recommended retail price and sales price for tobacco products in independent and convenience (small) retailers before and after the introduction of standardised tobacco packaging in the UK.

AIM: Recommended retail price (RRP) is a marketing strategy used by tobacco companies to maintain competitiveness, communicate product positioning and drive sales. We explored small retailer adherence to RRP before and after the introduction of the Standardised Packaging of Tobacco Products Regulations in the UK (fully implemented on 20 May 2017) which mandated standardised packaging of cigarettes and rolling tobacco, set minimum pack/pouch sizes and prohibited price-marking. METHOD: Monthly electronic point of sale data from 500 small retailers in England, Scotland and Wales were analysed. From May 2016 to October 2017, we monitored 20 of the best-selling fully branded tobacco products (15 factory-made cigarettes, 5 rolling tobacco) and their standardised equivalents. Adherence to RRP was measured as the average difference (%) between monthly RRPs and sales prices by pack type (fully branded vs standardised), price-marking on packaging and price segment. RESULTS: The average difference between RRP and sales price increased from +0.36% above RRP (SD=0.72) in May 2016, when only fully branded packs were sold, to +1.37% in October 2017 (SD=0.30), when standardised packs were mandatory. Increases above RRP for fully branded packs increased as they were phased out, with deviation greater for non-price-marked packs and premium products. DISCUSSION: Despite tobacco companies emphasising the importance of RRP, small retailers implemented small increases above RRP as standardised packaging was introduced. Consequently, any intended price changes by tobacco companies in response to the legislation (ie, to increase affordability or brand positioning) may be confounded by retailer behaviour, and such deviation may increase consumer price sensitivity.