Tobacco Products Directive Research Articles

Exclusive and dual use of electronic cigarettes among European youth in 32 countries with different regulatory landscapes

BackgroundThe Tobacco Products Directive (2014/40/EU) partially harmonised the regulation of electronic cigarettes (e-cigarettes) in Europe, but individual countries maintain jurisdiction over bans on use in public places, domestic advertising, taxation...

Method Development and Validation of an Aerosol Sampling Technique for the Analysis of Nicotine in Electronic Cigarette Aerosols.

Because of the increasing popularity of e-cigarettes, monitoring the e-cigarette market has become important for national health authorities to guarantee safety and quality. In the EU, the Tobacco Products Directive requires emission studies for e-cigarette products. The absence of industry guidelines for studying these emissions and the lack of proper validation in the literature led us to develop and validate a method using the total error approach for the determination of nicotine in e-cigarette aerosols. A commercial vaping device was used to generate aerosols, which were then collected on Cambridge filter pads and measured for nicotine concentration by UHPLC-DAD after extraction. The method was successfully validated by generating accuracy profiles, which show that the β-expectation tolerance intervals remained below the acceptance limits of ±20%. Within-run repeatability and intermediate precision were considered acceptable since the highest RSD value obtained was below 5%. The method was applied to 15 commercial e-liquids. A complete validation of a method for the analysis of e-cigarette emissions is presented, including several parameters that impact the accuracy and reproducibility. Similar systematic approaches for method development and validation could be used for other e-cigarette emission analysis methods to ensure the reliability of the measurements.

Smokers' support for the ban on sale of slim cigarettes in six European countries: findings from the EUREST-PLUS ITC Europe Surveys.

Background: Efforts to regulate tobacco products and reduce consumption in the European Union (EU) include the European Tobacco Products Directive (TPD), which went into force in May 2016. Despite the initial discussion to include a ban on sale of slim cigarettes, it was excluded in the final TPD. The main goal of this study was to examine support for a ban on slim cigarettes among smokers in six European Countries. Methods: Data from the 2018 (Wave 2) International Tobacco Control Policy Evaluation Project 6 European Country (ITC 6E) EUREST-PLUS project survey, a cross sectional study of adult smokers (n=5592) from Germany, Greece, Hungary, Poland, Romania, and Spain, was analysed. Descriptive statistics were used to estimate support for a ban on slim cigarettes by sociodemographic characteristics and smoking behaviors. Logistic regression analysis was used to examine factors associated with support for a ban on slim cigarettes and perceptions of harm. Results: Support for a ban on slims varied across countries, with highest support in Romania (33.8%), and lowest in Greece (18.0%). Female smokers (OR=0.78; 95%CI=0.67-0.91, daily smokers (OR=0.68; 95%CI=0.47-0.97), menthol smokers (OR=0.55; 95%CI=0.36-0.86), and smokers who did not have plans to quit within next six months (OR=0.45; 95%CI=0.36-0.56) had significantly lower odds of supporting a ban on slim cigarettes. Overall, 21% of smokers perceived slim cigarettes as less harmful than regular cigarettes. Conclusions: Support for a ban of slim cigarettes was relatively low among smokers, while misperceptions that slim cigarettes are less harmful is high, particularly among countries where slim cigarette use is more prevalent. Findings support a ban on slim cigarettes to reduce misperceptions around slim cigarettes being less harmful.

Innovations in Canada That May Inform the Next EU Tobacco Products Directive

Innovations in Canada That May Inform the Next EU Tobacco Products Directive

Thermodynamic behaviour of an e-cigarette: Investigation of nicotine delivery consistency using nicotine yield

In 2014, the Tobacco Product Directive imposed a regulatory framework to protect the users of vaping products. One of the items requires that vaping devices shall deliver nicotine doses at consistent levels. However, this item is not evident to grasp and results from a lack of understanding of the physical behaviour of a vaping device. This publication aims to provide a physical explanation of ”nicotine doses at a consistent levels”. Numerical and an experimental approaches are developed in parallel. The first is based on the Rayleigh distillation model to describe the vaporisation of a volume initially in liquid phase under vapour–liquid equilibrium conditions. The second generates emissions using in-lab or commercial e-liquids under standardised conditions (AFNOR XP-D90-300-3) and the Cubis atomiser with a 1Ω coil. The comparison is focused on the nicotine delivery efficiency obtained with these two approaches. Emissions are collected using a cold trap. The results show a mean nicotine recovery that is around 93% with a standard deviation of 12% over more 1000 tested e-liquids. A comparison of these results with simulation, allow assuming a complete vaporisation rather than a partial one. Therefore, the nicotine’s consistency postponed the problem of the consistency of the mass of e-the vaporised liquid. This consistency is verified under laboratory conditions (with a controlled and regulated power supply). In real life, the power units that are used in vaping products are discharging devices, and therefore the consistency will depend on the number of puffs expected, the power set-up and the battery’s characteristics.

Smokers’ support for the ban on sale of slim cigarettes in six European countries: findings from the EUREST-PLUS ITC Europe Surveys

Background: Efforts to regulate tobacco products and reduce consumption in the European Union (EU) include the European Tobacco Products Directive (TPD), which went into force in May 2016. Despite the initial discussion to include a ban on sale of slim cigarettes, it was excluded in the final TPD. The main goal of this study was to examine support for a ban on slim cigarettes among smokers in six European Countries. Methods: Data from the 2018 (Wave 2) International Tobacco Control Policy Evaluation Project 6 European Country (ITC 6E) EUREST-PLUS project survey, a cross sectional study of adult smokers (n=5592) from Germany, Greece, Hungary, Poland, Romania, and Spain, was analysed. Descriptive statistics were used to estimate support for a ban on slim cigarettes by sociodemographic characteristics and smoking behaviors. Logistic regression analysis was used to examine factors associated with support for a ban on slim cigarettes and perceptions of harm. Results: Support for a ban on slims varied across countries, with highest support in Romania (33.8%), and lowest in Greece (18.0%). Female smokers (OR=0.78; 95%CI=0.67-0.91, daily smokers (OR=0.68; 95%CI=0.47-0.97), menthol smokers (OR=0.55; 95%CI=0.36-0.86), and smokers who did not have plans to quit within next six months (OR=0.45; 95%CI=0.36-0.56) had significantly lower odds of supporting a ban on slim cigarettes. Overall, 21% of smokers perceived slim cigarettes as less harmful than regular cigarettes. Conclusions: Support for a ban of slim cigarettes was relatively low among smokers, while misperceptions that slim cigarettes are less harmful is high, particularly among countries where slim cigarette use is more prevalent. Findings support a ban on slim cigarettes to reduce misperceptions around slim cigarettes being less harmful.

Review of industry reports on EU priority tobacco additives part B: Methodological limitations.

The Tobacco Products Directive (TPD) defines enhanced reporting obligations applying to 15 priority additives added to cigarettes and roll-your-own tobacco. A consortium of 12 international tobacco companies submitted 14 reports that were reviewed by an independent scientific body within the Joint Action on Tobacco Control (JATC). The reports were evaluated in accordance with the TPD with regard to their comprehensiveness, methodology and conclusions. Here we present their significant identified methodological limitations.The toxicological and chemical evaluation in the industry reports was mainly based on comparative testing, which lacks discriminative power for products with high toxicity and variability, like cigarettes. The literature reviews were biased, the comparative chemical studies did not assess previously identified pyrolysis products, the toxicological evaluation did not include the assessment of inhalation toxicity, and pyrolysis products were not assessed in terms of toxicity, including their genotoxic and carcinogenic potential. For both chemistry and toxicity testing, the statistical approach applied to test the difference between test and additive-free control cigarettes resulted in a high chance of false negatives. The clinical study for inhalation facilitation and nicotine uptake had limitations concerning study design and statistical analysis, while addictiveness was not assessed. Finally, the methodology used to assess characterizing flavors was flawed.In conclusion, there are significant limitations in the methodology applied by the industry. Therefore, the provided reports are of insufficient quality and are clearly not suitable to decide whether a priority additive should be banned in tobacco products according to the TPD.

Smokers’ support for the ban on sale of slim cigarettes in six European countries: findings from the EUREST-PLUS ITC Europe Surveys

Background: Efforts to regulate tobacco products and reduce consumption in the European Union (EU) include the European Tobacco Products Directive (TPD), which went into force in May 2016. Despite the initial discussion to include a ban on sale of slim cigarettes, it was excluded in the final TPD. The main goal of this study was to examine support for a ban on slim cigarettes among smokers in six European Countries. Methods: Data from the 2018 (Wave 2) International Tobacco Control Policy Evaluation Project 6 European Country (ITC 6E) EUREST-PLUS project survey, a cross sectional study of adult smokers (n=5592) from Germany, Greece, Hungary, Poland, Romania, and Spain, was analysed. Descriptive statistics were used to estimate support for a ban on slim cigarettes by sociodemographic characteristics and smoking behaviors. Logistic regression analysis was used to examine factors associated with support for a ban on slim cigarettes and perceptions of harm. Results: Support for a ban on slims varied across countries, with highest support in Romania (33.8%), and lowest in Greece (18.0%). Female smokers (OR=0.78; 95%CI=0.67-0.91, daily smokers (OR=0.68; 95%CI=0.47-0.97), menthol smokers (OR=0.55; 95%CI=0.36-0.86), and smokers who did not have plans to quit within next six months (OR=0.45; 95%CI=0.36-0.56) had significantly lower odds of supporting a ban on slim cigarettes. Overall, 21% of smokers perceived slim cigarettes as less harmful than regular cigarettes. Conclusions: Support for a ban of slim cigarettes was relatively low among smokers, while misperceptions that slim cigarettes are less harmful is high, particularly among countries where slim cigarette use is more prevalent. Findings support a ban on slim cigarettes to reduce misperceptions around slim cigarettes being less harmful.

Review of industry reports on EU priority tobacco additives part A: Main outcomes and conclusions.

The European Union Tobacco Products Directive (EU TPD) mandates enhanced reporting obligations for tobacco manufacturers regarding 15 priority additives. Within the Joint Action on Tobacco Control (JATC), a review panel of independent experts was appointed for the scientific evaluation of the additive reports submitted by a consortium of 12 tobacco manufacturers. As required by the TPD, the reports were evaluated based on their comprehensiveness, methodology and conclusions. In addition, we evaluated the chemical, toxicological, addictive, inhalation facilitating and flavoring properties of the priority additives based on the submitted reports, supplemented by the panel’s expert knowledge and some independent literature. The industry concluded that none of the additives is associated with concern. Due to significant methodological limitations, we question the scientific validity of these conclusions and conclude that they are not warranted. Our review demonstrates that many issues regarding toxicity, addictiveness and attractiveness of the additives have not been sufficiently addressed, and therefore concerns remain. For example, menthol facilitates inhalation by activation of the cooling receptor TRPM8. The addition of sorbitol and guar gum leads to a significant increase of aldehydes that may contribute to toxicity and addictiveness. Titanium dioxide particles (aerodynamic diameter <10 µm) are legally classified as carcinogenic when inhaled. For diacetyl no report was provided. Overall, the industry reports were not comprehensive, and the information presented provides an insufficient basis for the regulation of most additives. We, therefore, advise MS to consider alternative approaches such as the precautionary principle.

Work Package 6 of the Joint Action on Tobacco Control 2: Enforcement of the Tobacco Products Directive through the establishment of a knowledge sharing hub network

Work Package 6 of the Joint Action on Tobacco Control 2: Enforcement of the Tobacco Products Directive through the establishment of a knowledge sharing hub network

An analysis of cigarette sales during Poland's menthol cigarette sales ban: small effects with large policy implications.

BackgroundIn May 2020, the European Union Tobacco Products Directive mandated that EU member states, including Poland, ban the sale of menthol cigarettes. With menthol making up 28% of cigarette sales before the ban, Poland is the country with likely the largest menthol cigarette sales share in the world to ban their sale. We analyze how this ban changed the Polish tobacco market.MethodsWe use monthly NielsenIQ data (May 2018–April 2021) on sales of cigarettes and roll-your-own tobacco by menthol and standard flavor in eight regions of Poland. We set up a bite-style regression model controlling for pre-ban menthol share, climate, border opening status, and Apple movement data to estimate the effect of the May 2020 menthol ban.ResultsWe find menthol cigarette sales fell at least 97% after the menthol cigarette ban across Poland and standard cigarette sales replaced them. Regression modeling indicates that total cigarette sales fell, after the ban, an average of 2.2 sticks per capita per month, equal to a 2.9% decline, however, results were not significant (P = 0.199). The bite component of our model reveals total cigarette sales did decline significantly in the regions with the highest pre-ban menthol sales shares. Roll-your-own tobacco sales increased by a statistically insignificant 0.03 stick-equivalents after the ban (P = 0.798). Product prices also fell in the wake of the menthol ban.ConclusionsIn Poland, the EU state with the one of the largest pre-ban menthol shares, we find mixed evidence that the ban is working as intended.

Tobacco products in the European Union Common Entry Gate (EU-CEG): A tool for monitoring the EU tobacco products directive.

INTRODUCTIONUnder the European Union (EU) Tobacco Products Directive (2014/40/EU) (TPD), manufacturers and importers of tobacco products are required to report information to the European Commission (EC) and Member States (MS) on products intended to be placed on the market. We describe the distribution of notifications to the EU Common Entry Gate (EU-CEG) and identify key fields for improvement on reporting cigarettes or roll-your-own (RYO) tobacco.METHODSA cross-sectional analysis of secondary data reported in the EU-CEG was conducted for tobacco products notified within EU-CEG between June 2016 and October 2019 for 12 EU MS. Analysis of compliance to specific regulations for priority additives that refer to cigarettes and RYO was conducted for 10 EU countries.RESULTSOverall, 39170 tobacco products were notified. This included 16762 (42.8%) notifications of cigars, followed by cigarettes 11242 (28.7 %), waterpipes 3291 (8.4%), cigarillos (n=1783), pipe (n=1715), RYO (n=1635), chewing tobacco (n=1021), novel tobacco products (n=839), herbal products for smoking (n=535), other (n=258), nasal (n=74) and oral tobacco (n=15). In cigarettes and RYO tobacco products, the proportion of ingredients notified in all countries that contained an unknown Chemical Services (CAS) number was 3.8% and 2.1%, respectively. The proportion of underreporting flagging of priority additives ranged from 15.9% in Malta to 41.3% in Lithuania, the mean proportion of underreporting of the variable ‘priority additive’ for the 10 countries together was 24.7%.CONCLUSIONSIn the EU-CEG data base, for the period of analysis, a significant number of product notifications took place while large variations in the number of types of tobacco products notified across EU countries was noted. The timely monitoring of these data is needed so that products non-compliant within the EU-CEG system are assessed.

Correlates of e-cigarette use before and after comprehensive regulatory changes and e-liquid flavour ban among general population.

In 2016, the Finnish Tobacco Act was revised to harmonise e-cigarette regulations with the EU Tobacco Products Directive. Unlike before, the sale of nicotine-containing e-liquids was allowed while additional national regulations included, for example, a ban for other than unflavoured and tobacco-flavoured e-liquids. This study examines the correlates of e-cigarette use before and after the comprehensive regulatory change, and characteristics and correlates of flavoured e-cigarette use after the flavour ban in the general Finnish population. Repeated cross-sectional population-based drug surveys for 15-69-year-olds in 2014 (n=3485; 50% response rate) and in 2018 (n=3229; 46%). Correlates of e-cigarette use were studied with logistic regression models. Current e-cigarette use remained infrequent (approximately 2%) and the correlates of e-cigarette use varied only slightly between the study years. In 2018, of past-year e-cigarette users (n=316), 43% used unflavoured e-liquids, 24% used tobacco and 43% used other flavours, fruits being the most common. In univariate models, demographic variables, smoking and e-cigarette use-related factors were associated with flavoured e-cigarette use. In multivariable models, those who used e-cigarettes to experiment used unflavoured e-cigarettes more likely than other than tobacco flavours (odds ratio 3.00, 95% confidence interval 1.15-7.82). In Finland, the regulated entry of nicotine-containing e-liquids to retail sales has not led to increased e-cigarette use in the general population. After the flavour ban, other than tobacco-flavoured e-cigarette use still occurs. The use of flavoured e-cigarettes is associated with reasons for e-cigarette use. Flavoured e-cigarette use and its correlates warrant further monitoring.

E-Liquids from Seven European Countries-Warnings Analysis and Freebase Nicotine Content.

Electronic cigarettes are available in a variety of devices with e-liquids also available in many flavors, and nicotine concentrations, albeit less than 20 mg/mL in Europe. Given the dynamics of these products, it is important to evaluate product content, including labeling, nicotine content versus labeled claim, nicotine form, and other aspects that may help policy decisions and align with the Tobacco Product Directive (TPD). Herein, we performed a study on 86 e-liquids from seven European countries (Croatia, Czech Republic, France, Germany, Italy, Poland, and the United Kingdom) with 34 different liquid brands and 57 different flavors. Nicotine content versus labeled claim, labeling, volume, pH, and nicotine form (i.e., freebase nicotine) were evaluated. From all tested products, eight of them from Germany, Poland, and UK (from 3 to 18 mg/mL), met the ±2% criteria. The ±10% criteria was fulfilled by 50 (58.1%) liquids from all countries. Among 71 liquids which contained nicotine, (one e-liquid labeled as 6 mg/mL had no nicotine level quantified), the amount of freebase nicotine differed from 0 to 97.8%, with a mean value 56.5 ± 35.7. None of the tested liquids had nicotine salt listed in the ingredients. Therefore, a low level of freebase nicotine in some liquids was most likely achieved by added flavorings. All tested liquids presented in this study met the basic requirements of the TPD. There were differences in the scope of information about harmfulness, type of warnings on packaging, attaching leaflets, placing graphic symbols, and discrepancies between the declared and quantified nicotine concentrations.

Changes in electronic cigarette use and label awareness among smokers before and after the European Tobacco Products Directive implementation in six European countries: Findings from the EUREST-PLUS ITC Europe Surveys

Changes in electronic cigarette use and label awareness among smokers before and after the European Tobacco Products Directive implementation in six European countries: Findings from the EUREST-PLUS ITC Europe Surveys

Development and testing of relative risk-based health messages for electronic cigarette products

BackgroundHealth messages on e-cigarette packs emphasise nicotine addiction or harms using similar wording to warnings on cigarette packs. These may not be appropriate for e-cigarettes which constitute a reduced risk alternative for smokers. This research aimed to (1) develop and test a selection of relative risk messages for e-cigarette products; (2) compare these to the two current EU Tobacco Products Directive (TPD) nicotine addiction messages; and (3) explore differences between smokers, non-smokers and dual users.MethodTwenty-six messages focusing on either harm-reduction or cessation were developed and rated by multidisciplinary experts for accuracy, persuasiveness and clarity. The eight highest ranking messages were compared alongside the TPD messages in a sample of 983 European residents (316 smokers, 327 non-smokers, 340 dual users) on understandability, believability and convincingness.ResultsOn all three constructs combined, the two TPD messages rated the highest, closely followed by four relative risk messages “Completely switching to e-cigarettes lowers your risk of smoking related diseases”, “Use of this product is much less harmful than smoking”, “Completely switching to e-cigarettes is a healthier alternative to smoking”, and “This product presents substantially lower risks to health than cigarettes” which did not differ statistically from the TPD messages. Non-smokers rated TPD1 significantly higher overall than dual users. Dual users rated “This product is a safer alternative to smoking” significantly higher than non-smokers. Messages did not differ on understandability.ConclusionsThese alternative messages provide a useful resource for future research and for policy makers considering updating e-cigarette product labelling.

Was the implementation of standardised tobacco packaging legislation in England associated with changes in smoking prevalence? A segmented regression analysis between 2006 and 2019

Background and aimIn 2016, England initiated the implementation of standardised tobacco packaging, introduced in conjunction with minimum pack sizes and other measures included in the 2014 European Tobacco Products Directive,...

Development of a “Freeze-Pour” Sample Preparation Method for the GC Analysis of Semivolatile Flavouring Chemicals Present in E-cigarette Refill Liquids

During the past decade, e-cigarettes have become increasingly popular. To guarantee their safe use and to comply with the notification requirements of the EU Tobacco Product Directive, the EU member state regulatory authorities need information about the exact composition of the e-liquids and their emissions. However, one of the challenges encountered during the analysis of e-liquids is the presence of the highly abundant e-liquid matrix components propylene glycol and glycerol. In this study, headspace gas chromatography (HS-GC) analysis is presented as an excellent method for the analysis of high volatile components in e-liquids. For the analysis of semivolatile ingredients, an additional sample preparation step is proposed based on a liquid–liquid extraction (LLE) followed by a freeze-out of the matrix components. The developed method was successfully validated in accordance with the validation requirements of ICH guidelines for the quantification of four flavourings with a potential health concern for e-cigarette users.

The Tobacco Endgame-Eradicating a Worsening Epidemic: A Joint Opinion From the American Heart Association, World Heart Federation, American College of Cardiology, and the European Society of Cardiology.

The Tobacco Endgame-Eradicating a Worsening Epidemic: A Joint Opinion From the American Heart Association, World Heart Federation, American College of Cardiology, and the European Society of Cardiology.

Implementation of e-cigarette regulation through the EU Tobacco Products Directive (2016) in Wales, Scotland and England from the perspectives of stakeholders involved in policy introduction and enforcement.

INTRODUCTIONFrom May 2016, the European Union introduced the Tobacco Products Directive (TPD) regulations, which included restrictions to advertising and new safety and labeling standards for e-cigarette products. This represented the first supranational policy regulating e-cigarette sales and marketing. This study explores perceptions of TPD and its implementation in Wales, Scotland and England, from perspectives of stakeholders involved in tobacco and e-cigarette policy and implementation in each nation.METHODSSemi-structured qualitative interviews were completed with 12 stakeholders from government and third sector organizations in the UK involved in tobacco control policy-making processes, and Trading Standards Officers from 13 UK local authorities. Data were analyzed thematically and a sub-sample double-coded.RESULTSStakeholders held varying views of e-cigarettes, recognizing potential benefits and harms of both the products and the new policy actions. Nevertheless, most perceived TPD to be a positive step in introducing regulation for e-cigarettes. Compliance was perceived as high across nations, although stakeholders highlighted product adaptations to circumvent restrictions, and absence of controls on non-nicotine products. Budgetary and staffing limitations also meant that capacity to communicate new measures, and enforce change, was limited. This led to a gap occupied by industry representatives, who played a substantial role in preparing retailers for adoption of new measures.CONCLUSIONSTPD policy roll-out was largely perceived positively and as having been effectively implemented. However, contribution of industry to communication of new measures and absence of resourcing for effective communication perhaps introduced widespread innovations within regulations. While largely viewed positively, some refinements to device regulations were proposed.