Impacts of EU Tobacco Products Directive regulations on use of e-cigarettes in adolescents in Great Britain: a natural experiment evaluation

E-cigarettes and smoking cessation

Invented in China in 2003, e-cigarettes entered European Union (EU) markets around 200715 and began to gain significant traction as smoking-cessation aids around 2011, with rapid growth over the next couple of years. 16 The devices themselves are rapidly changing, with early products looking very much like cigarettes. More recent changes in product design have moved away from resemblance to cigarettes, with increased popularity of tank-based devices. Many people argue that public health communities should endorse e-cigarettes as a means of helping smokers to quit the more harmful behaviour of smoking. 17,18 Although long-term health effects are unlikely to be known for some time, some studies show important acute health benefits of switching to e-cigarettes. 19 Hence, e-cigarettes, where effective as cessation aids, may play an important role in reducing mortality and morbidity. 20

UK trials have found that e-cigarettes, accompanied with behavioural support, can be more effective than nicotine replacement therapy (NRT) in supporting cessation. 21 Nevertheless, in early 2020, the World Health Organization still described evidence for the effectiveness of e-cigarettes in cessation as inconclusive. 22 More recently, a Cochrane review concluded that there was moderate-certainty evidence that e-cigarettes are effective in helping smokers to quit and, indeed, appear to be more effective than NRT. 23 Public Health England’s recent evidence update argues that evidence is now increasingly strong that e-cigarettes make a significant positive contribution to public health via supporting cessation. 24 Indeed, reflecting this rapidly advancing evidence base, in 2021, regulators set out new guidance on how e-cigarettes might be offered on prescription as a smoking-cessation aid in England. 25

Although there is emerging consensus that e-cigarettes have a role to play in harm-reduction strategies,26 there is also consensus that e-cigarettes are not harmless. 27 Many people in the public health community continue to argue for caution until more is known about the potential harms of e-cigarettes. 28,29 However, although much has been written about a binary divide between ‘enthusiasts’ who wish to harness the potential of e-cigarettes for cessation and ‘opponents’ who see e-cigarettes as a threat to young people,30 in reality, positions are often more nuanced. Many people are both enthusiastic about the role of e-cigarettes in cessation, while taking seriously the need to prevent use by children and young people. 31 For people accepting a position that e-cigarettes have a role in supporting cessation, it remains important that use is restricted to smokers or ex-smokers as a means of quitting and preventing relapse back to smoking. 32

Young people’s use of e-cigarettes

Today’s young people have grown up in an environment of falling prevalence of tobacco use, among adults and peers. However, today’s young people are also the first generation to have grown up in a time when e-cigarettes have become a major presence in UK society. 33 The growing presence of e-cigarettes has led to some concerns that e-cigarettes might lead to a new generation of tobacco-naive young people addicted to nicotine. Some concerns were expressed early in the emergence of e-cigarettes that marketing for e-cigarettes used approaches that mirror those used by the tobacco industry, targeting young people as potential new consumers. 34 Indeed, as tobacco companies have bought e-cigarette companies or developed their own products, there is increasing overlap between actors responsible for these markets. 35 E-cigarettes commonly have features that many people argue might appeal to young people, such as their colourful and often sweetly flavoured nature. 36,37

Young people’s use of e-cigarettes did not begin to be measured in UK social surveys until around 2013. Early estimates from Wales indicated that ever use of e-cigarettes was approximately equal to ever use of tobacco cigarettes, as 12% of young people had tried vaping and 12% had also tried smoking. 38 However, the proportion of young people reporting more regular use was small. Over the next 2–3 years, data accumulated from surveys across UK nations (see Figure 1), reinforcing this picture of sharp increase in experimentation with e-cigarette use, but with regular use remaining low and concentrated among smokers. 24,39

FIGURE 1.

Percentages of young people who have ever used an e-cigarette or who use an e-cigarette at least weekly, by smoking status. Reproduced with permission from Bauld et al. 39 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original text.

Copyright © 2023 Moore et al.

Nevertheless, rapid growth of experimentation in the early years of the emergence of e-cigarettes in the UK signalled a need for careful ongoing monitoring. Concerns that e-cigarettes may become harmful for young people centred both on potential indirect harms, via their perceived potential role in reversing successes in reducing smoking uptake, but also direct harms of use by young people who would not otherwise be smoking.

Effects of e-cigarettes on young people’s smoking uptake

There are two major hypothesis surrounding potential mechanisms through which e-cigarettes may lead to increases in young people’s smoking uptake: (1) the gateway hypothesis and (2) the renormalisation hypothesis.

Use of e-cigarettes among young people as an emerging public health risk in its own right

Although links between e-cigarettes and smoking have dominated debates regarding potential harms of e-cigarettes to young people, e-cigarettes themselves are unlikely to be harmless. Hence, although switching from tobacco to e-cigarettes is likely to reduce harm, taking up e-cigarette use without prior smoking introduces new potential for, as yet, unknown harms. In one recent study,65 estimates of the extent to which risk-adjusted nicotine product days decreased over time as tobacco use fell but e-cigarette use grew were described as highly dependent on assumptions regarding risks of e-cigarettes relative to tobacco. Although commonly based on animal models and, therefore, with questionable transferability, common arguments for regulating e-cigarettes to prevent young people from using them have included potential impacts of nicotine on brain development among young people. 66

As described, few young people in the UK have historically used e-cigarettes regularly, unless they are also smokers. However, in the USA, the 2018 NYTS indicated that in the space of a year the percentage of high school students reporting past 30-day use of e-cigarettes doubled to almost one in five, with more than one in four young people reporting past 30-day vaping in 2019. 67 This growth was framed widely as an epidemic of young people’s vaping,68 triggering international calls for regulation. In 2019, Hammond et al. published an influential analysis of change in young people’s smoking and e-cigarette use from 2017 to 2018, finding increases in vaping in the USA and Canada, although no growth in England. In Canada, analyses indicated that this increase in vaping was accompanied by growth in smoking. 69 In 2020, the authors published an update in which data were calibrated with external data sources, with the consequence that the previously reported increase in smoking in Canada was attenuated. Hence, although revised analysis weakened common interpretations that e-cigarettes were acting as a pathway into smoking, the analysis did signal rapid growth in young people’s use of e-cigarettes as a potential problem in its own right. Newer data from the 2020 and 2021 NYTSs indicate that rapid growth in vaping from 2017 to 2019 did quickly begin to subside. 70,71

In the context of these rising international concerns about the growth of young people’s use of e-cigarettes, concerns regarding the safety of e-cigarettes, particularly for young people, were further raised by the EVALI (e-cigarette or vaping use-associated lung injury) outbreak. 67 This was an outbreak of vaping-related lung injury, which led to a number of deaths, predominantly in the USA in 2019, attributed to the specific chemicals tetrahydrocannabinol and vitamin E acetate,72 in unregulated devices. The outbreak received intense media coverage, and one study73 found the outbreak to be associated with increased risk perceptions for e-cigarettes among English adult smokers. Following this outbreak, debate regarding potential for an epidemic of young people’s smoking in the UK intensified. 74 One group of paediatric health-care professionals, for example, wrote that with 30% of high school children in America using e-cigarettes, most of whom had never smoked tobacco, similar rates were inevitable in the UK. 75 The claim that most use was occurring among tobacco-naive young people is not borne out by reanalysis of the NYTS data, which finds that most use, particularly regular use, occurred among young people who had smoked. 76 However, this reflected growing concerns that the US epidemic would cross the Atlantic and that e-cigarette use in itself might become a commonly adopted risk behaviour among young people who would not otherwise be smokers.

E-cigarette regulation in the UK

Divergence in positions on e-cigarettes among the public health community is reflected in international approaches to regulation,77 which have ranged from highly restrictive regulation in countries such as Australia78 to more liberal approaches in countries such as the UK, where no specific regulation existed prior to 2015. Age of sales regulations for e-cigarettes were implemented in England and Wales in late 2015 and in Scotland in early 2017. In Wales, the Welsh Government’s 2015 Public Health Bill attempted to introduce legislation that would have prohibited the use of e-cigarettes in any place where tobacco cigarettes are currently prohibited. 79 This failed to pass into law after a last-minute loss of cross-party support led to a minority Labour government losing at the final stage of the legislative process. The bill returned in 2017, re-introduced by a minority Labour Government, with provisions relating to e-cigarettes removed. 80 Key arguments against including e-cigarettes alongside bans on smoking in public places have included that this may undermine quit attempts by reducing relative advantage of e-cigarettes over tobacco. 81

In the meantime, in May 2016, Tobacco Products Directive (TPD) regulations were introduced in EU member states. The TPD regulations included a broad suite of regulations for tobacco, many of which reflected tobacco control actions already implemented in the UK, with exceptions including a ban on sales of smaller packs of tobacco cigarettes and (later) bans on sale of menthol-flavoured cigarettes. 82 Article 20 was specific to e-cigarettes, and represented the first major supra-national regulation of e-cigarettes. TPD regulations prohibited cross-border advertising of e-cigarettes, with immediate effect from May 2016. Recent market liberalisation in Canada has been associated with increased marketing exposure and use of e-cigarettes among young people, with comprehensive provincial restrictions associated with lower exposure and use. 83 Hence, it is plausible that marketing restriction within TPD may act to reduce young people’s exposure and use. TPD also included a suite of regulations on the products themselves, which were to be more gradually introduced, with full implementation to be achieved by May 2017. These regulations included a mandatory warning across 30% of the packet indicating that the products contain nicotine, which is a highly addictive substance. Manufacturers are mandated to notify the Medicines and Healthcare products Regulatory Agency of intention to launch new products 6 months in advance, including notification of all product ingredients. e-cigarettes and liquids are to be sold in tamper-proof containers to include an information leaflet listing all ingredients, with nicotine strength limited to 20 mg/ml. Device refills were restricted in size. TPD regulations aligned e-cigarettes with tobacco in so far as they involve regulation under the banner of a ‘Tobacco Products Directive’, but e-cigarettes themselves are not referred to as tobacco products. There is some limited evidence that first use of flavoured e-cigarettes is associated with more persistent use among young people. 84 Hence, some EU member states went beyond mandatory requirements of TPD regulations, through introduction of flavour regulations left within TPD for individual member states to determine,77 although the UK has not to date.

The regulations were a cause of concern for the vaping community and some scientists who argued, in particular, that a reduction in nicotine strength might inhibit the usefulness of e-cigarettes as cessation devices or cause users to relapse to smoking, as the lower strength may not satisfy cravings. 85 The warning focused on the addictiveness of nicotine was found in one study86 to likely put smokers off using e-cigarettes as cessation devices. However, surveys of adult smokers, ex-smokers and vapers indicate that, after implementation, the regulations went largely unnoticed by many, with most using compliant devices while unaware that these had changed. 87 E-cigarettes remain the most popular smoking-cessation devices used by smokers and recent ex-smokers in the UK. 16 Part of the rationale for introduction of these regulations include assumptions that e-cigarettes can develop into a gateway to nicotine addiction and tobacco consumption, and that e-cigarettes mimic and normalise the act of smoking. 82 To date, however, there has been limited evaluation in the UK of (1) the role of e-cigarettes in renormalising smoking and (2) the impacts of this regulation on children and young people’s use of e-cigarettes (and tobacco).

Data sources, collection and handling

We obtained data from routinely collected school-based surveys in each UK nation. Although some of these surveys go back to the 1980s, we made an a priori decision to restrict our analyses to data sets from 1998 to 2019 because published estimates indicate that smoking rates climbed up to this point, but have followed a prolonged period of decline ever since.

Data from Wales were obtained from the Welsh Health Behaviour in School-aged Children (HBSC) survey, conducted as part of an international World Health Organization collaboration every 2–4 years,92 and the biennial School Health Research Network (SHRN) survey. 93 The SHRN survey was introduced in 2015 and was modelled on the HBSC survey, and from 2017 the SHRN survey incorporated the smaller HBSC survey as a component of it. Hence, HBSC survey data were obtained from 1998 to 2013, with SHRN survey data from 2015 to 2019. Data for Wales before 2013 were provided by the Welsh Government. SHRN and HBSC data from 2013 onwards are held by the principal investigator’s research group.

Although HBSC surveys are also conducted in England and Scotland, neither country included measures of e-cigarette use prior to TPD implementation, and these surveys are conducted only once every 4 years. Hence, in Scotland and England, we used the larger and more frequent Scottish Schools Adolescent Lifestyle and Substance Use Survey (SALSUS)94 and Smoking, Drinking and Drug Use (SDDU) survey in England. 95 In Scotland, the SALSUS is a bi-ennial, school-based survey undertaken in local authority and independent schools. E-cigarette use questions were first incorporated into the SALSUS in 2013. The UK data service includes a time series data set that provides ready-pooled data through to 2013. Our original intention was to use the SALSUS planned for 2017 and 2019 as post-TPD data sets in Scotland; however, SALSUS 2017 was postponed to 2018,and no data were collected in 2019. Hence, we integrated measures from the 2015 and 2018 data sets into the time series data set, providing only one post-TPD survey for Scotland. In England, the SDDU survey was conducted annually until 2014, but then moved to a bi-ennial cycle. Measures of e-cigarette use were included in the SDDU survey from 2014. The SDDU survey shares substantial overlap with the SALSUS, including use of similar measures of smoking and e-cigarette use. Data sets from 1998 to 2018 were obtained via the UK data service. Data files were combined into a single data set and stored on a secured network at Cardiff University. The Cardiff University-owned Welsh data will be retained, and models updated with newer data following completion of this study. Terms of use for the third party-owned data sets require these data to be deleted following completion of the use period, currently the end of 2022.

Sample sizes and response rates

Table 1 provides sample sizes by country and survey year, overall and for the target age group. Survey response rates, where available, are presented in Appendix 1, Table 19. These data indicate a gradual decline in response rates over time in Scotland (from 70% in 1998 to 52% in 2018), and a much larger decline in England (from 70% to 22%). However, there was recent growth in response rates in Wales, with the 2019 SHRN survey achieving a response rate of 77%.

Study measures

Statistical analysis of survey data

Analyses were based on a statistical analysis plan agreed with our Study Steering Committee in advance of data sets being combined for analysis. Analyses completed at each stage of the study were presented to the committee prior to submission for publication. Although our primary aim was to evaluate impacts of TPD, analyses are described (and presented) in the order in which they were undertaken, in line with our overall evaluation and integration framework (see Figure 2), including analyses of:

1. trajectories in young people’s smoking before and after the emergence of e-cigarettes (but prior to TPD)

2. change in young people’s e-cigarette use following the implementation of TPD

3. change in trend for young people’s smoking following the 2016 suite of tobacco control legislation.

As described in our evaluation and integration framework in Figure 2, our analysis of trends in young people’s smoking prior to TPD is conceived as an element of our process evaluation, in that this provides an understanding of the epidemiological context into which intervention was introduced. This analysis is, however, described in this section to limit repetition due to methodological similarity with our primary statistical analysis.

Procedure for dealing with missing data

The main outcomes for each of our objectives were available for ≥95% of respondents. For our overall primary outcome (i.e. ever e-cigarette use), data were available for 95% of young people, whereas 97–98% of young people were included in the final analytical samples for tobacco use. Hence, no imputation was undertaken, and analyses are based on complete cases.

Weighting

There is inconsistency within surveys over time in whether or not weighting is used to ensure national representativeness. Weights were included in data sets from 2006 in Scotland, 2009 in Wales and 2010 in England. In Wales, following movement from a sample to a whole population survey, weights were no longer used after 2013. Weights are calculated on the basis of the composition of the samples as a whole; however, in England and Wales, our analyses focuses on subsets of available data to harmonise age groups across countries. In plots of smoking prevalence trends over time using weighted (where available) and unweighted data, differences between these were barely discernible. Hence, for tobacco use models, we ran analyses using unweighted data, re-running whole group models with weights applied where available, as a sensitivity analyses. Survey weights were available in Scotland and England (but not Wales) for all surveys since first measurement of e-cigarette use. Hence, whole group and subgroup analyses for e-cigarette use in England and Scotland are presented with and without weights.

Qualitative interviews with young people

Retailer audits and interviews with professional groups

Quantitative process indicators

For the 2017 SHRN survey, a number of questions were added in consultation with our patient and public involvement group to provide a snapshot of the prevalence of potential mechanisms through which TPD may impact pupil’s use of e-cigarettes, and were linked to research questions on young people’s perceptions of risks and norms for e-cigarette use and tobacco (see Table 2). In our protocol, in response to PHR programme feedback, we indicated that we would request to add questions on where young people obtained e-cigarettes from and whether or not e-cigarettes used by young people contained nicotine. In addition, we included measures of risk perceptions for e-cigarettes compare with tobacco, exposure to marketing and perceived parental attitudes, mapping onto themes arising from our qualitative analysis. Most items were repeated in 2019, allowing examination of post-legislation change over time. In both cases, owing to pressures on the survey, items were asked of a random subsample of participants, rather than all survey participants.

Analysis of process evaluation data

All qualitative interviews were recorded and transcribed verbatim, with identifiable details (e.g. names of individuals and organisations) removed during and following transcription. The transcribed data were subjected to thematic analyses using Braun and Clarke’s102 six-step approach, which included (1) data familiarisation, (2) generating initial codes, (3) searching for themes, (4) reviewing themes, (5) defining themes and (6) writing up the account. Data analysis and data collection were conducted in parallel. Philosophically, the analyses were conducted through an abductive critical realist lens, beginning with exploration of predefined themes derived from the intervention logic model, and pursuing themes that emerged inductively from earlier interviews in later ones. A first researcher developed draft coding frames, with a sample of interviews second coded by a second researcher. Inconsistencies and disagreements were resolved through discussion with other members of the process evaluation subteam where necessary. For pupil interviews, which included a longitudinal cohort of young people and a cross-sectional sample of pupils recruited at follow-up only, the longitudinal and cross-sectional data were analysed as separate data sets prior to synthesis of themes across data sets. For structured observations, percentage interobserver agreement is presented for each item. One observer was a priori assigned as the primary observer, with percentages of retailers selling TPD-compliant products at each wave presented by retailer type, according to the primary coder. For quantitative process indicators, simple descriptive statistics are presented graphically by year the questions were asked (i.e. 2017 and 2019). These statistics are presented alongside the themes from the qualitative analyses of pupil data to examine the extent to which views expressed in qualitative interviews concur with, or contradict, views expressed in the national surveys.

Combining data sources

Our sampling methods for qualitative process evaluation components were directed towards obtaining views from a diverse range of participants, rather than representativeness. By contrast, quantitative surveys aimed for representative of participants’ respective countries. This combination enables us to advance nuanced explanations for quantitative trends, and examine the extent to which views expressed within our qualitative interviews concur with, contradict or build on survey fundings. At each phase, quantitative and qualitative data analyses were conducted in parallel, but converged following analysis. Qualitative and quantitative analyses were undertaken by different subgroups, with integration of quantitative and qualitative data subsequently focused on areas in which data sources aligned, challenged one another’s conclusions or added further nuance and explanation. Study components were synthesised into a whole using an evaluation and integration framework based on MRC guidance for process evaluation90 (see Figure 2), with data sources organised and presented chronologically rather than by method. Although we considered a more traditional presentation by method, with effects data followed by process evaluation data, this would involve a potentially confusing rotation between a range of different time frames. Hence, the most coherent means of narrating the current study as a whole was to position the impact of TPD as the ending of the story. Hence, Chapter 3 presents data on the context into which TPD was introduced (i.e. pre-implementation trends in smoking and young people’s perceptions of vaping), Chapter 4 presents data from policy stakeholders, TSOs and retailers on implementation of legislation, before Chapter 5 presents data on mechanisms of change and post-legislation vaping and smoking outcomes.

Owing to significant policy interest in findings and the fast-moving nature of this evidence base, we chose to conduct analyses in a sequential manner and publish these as they were completed, rather than waiting for the final report. Our analyses of smoking trends during the emergence of e-cigarettes was, for example, one of the first of its type (and formed part of an evidence review on e-cigarettes and smoking uptake within National Institute for Health and Care Excellence guideline development immediately after publication);103 however, a number of similar analyses have since been published internationally, as described in Chapter 1. All findings have been published under Creative Commons Attribution licenses that allow adaptation and re-use of material for any purpose so long as the original work is properly cited. The original contribution of this report relates to the synthesis of previously published components, and additional unpublished data, to tell the story of the study as a whole. We indicate at the beginning of each chapter which elements draw on previously published sources, and which are new.

Cross-country integration

The quantitative elements of the study involve pooling of data sets collected at differing time points, using slightly different questions in each nation. The most robust analysis available to test the impact of TPD on vaping rates is the Welsh data, which (1) is available in a monthly format, therefore, providing multiple time points within the same survey year, and (2) includes data on ever e-cigarette use since 2013, enabling a segmented regression approach. However, this is supplemented by more crude before-and-after analyses of e-cigarette and tobacco use rates across all three countries, using an integrated three-country data set to examine the transferability or context specificity of findings relating to change in trend in our primary statistical analysis in Wales to other nations in Great Britain. Analyses of tobacco use draw on an integrated three-country data set, with adjustment for country. The process evaluation is conducted using harmonised methods across countries and was analysed as a single data set.

Ethics and consent

Ethics approval was provided by the Cardiff University School of Social Sciences Research Ethics Committee (reference SREC/2188). Surveys included in secondary analyses used opt-out parental consent approaches, in which parents are informed about the study and provided the opportunity to opt their child out of the research. Opt-out approaches are preferred in low-risk school-based research with adolescents, as requiring active parental consent tends to lead to exclusion of the voices of higher-risk groups from research. 104 The consent process for pupil interviews comprised the following three stages: (1) school-level consent for the young people to be invited, (2) letters for parents describing the study and (3) consent from selected young people. School staff identified groups of young people who were interested in taking part and gave students information and consent materials to discuss with their parents 2 weeks prior to interviews. A summary of the study information was provided to young people on the day of interviews and a consent form completed. At phase 2, schools were asked to remind parents of the study and young people were reminded that they were under no obligation to take part again if they did not wish to, and consent repeated. Our original intention, as reflected within the proposal approved by the PHR Funding Committee, was to use a more typical opt-out consent process for interviews, which has been used in other similar parallel interview research about e-cigarettes with children as young as 7 years. 62 However, our ethics committee initially asked us to use an opt-in method for our first round of interviews. Prior to 2018 interviews, this decision was appealed and reversed with the support of our Study Steering Committee and the National Institute for Health and Care Research (NIHR) Research Manager. Opt-out consent methods were, therefore, used for follow-up interviews, with the exception of one school within a local authority in Scotland, which required that parents provide written consent for their child to take part. For adult interviewees, information sheets were provided in advance of an interview taking place, and a consent form completed prior to the interview.

Patient and public involvement

DECIPHer’s (the Centre for Development, Evaluation, Complexity and Implementation in Public Health Improvement’s) young people’s advisory group ALPHA were consulted in the development of the original grant application. Subsequently, ALPHA advised on study materials for qualitative interviews, and the selection of quantitative process indicators included in the 2017 and 2019 SHRN surveys. ALPHA also contributed to the drafting of the lay summary for this report via group discussion of a draft and provision of comments. Via the SHRN, we also discussed the study with school staff and education stakeholders in several webinars. Research user perspectives at the level of policy and third-sector representation were included via our Study Steering Committee.

Study management

The outcomes and process evaluations were managed by separate individuals, with integration of study components led by the principal investigator. Rachel Brown managed the process evaluation and oversaw collection and analysis of primary data throughout the study. Britt Hallingberg managed the quantitative outcomes evaluation, including the development and implementation of the statistical analysis plan, with oversight and guidance from senior statistician Linsay Gray. Nicholas Page covered Britt Hallingberg’s role during a period of maternity leave in late 2018/early 2019, and implemented short-term effect analyses during this time. Britt Hallingberg moved from Cardiff University to Cardiff Metropolitan University in 2019, but was appointed on an Honorary contract with Cardiff University and continued to manage the secondary data analysis. Marcus Munafò led the Bristol subcontract and was responsible for delegation of responsibilities to research staff in the Bristol study arm, with Linda Bauld fulfilling this role in Stirling. Linda Bauld left the University of Stirling for a post in University of Edinburgh on completion of the primary research in late 2018, and responsibility for the Stirling arm was assumed by Jennifer McKell, supported by Anne-Marie Mackintosh. Monthly or bi-monthly Study Management Group meetings, including co-investigators and employed staff, were held throughout the study and were chaired by the principal investigator. Additional small group operational meetings were held during periods of data collection. The study had a planned pause period from April 2019 to October 2020 while longer-term data were awaited for quantitative analyses and during which no process data were collected. The Study Management Team met every 4–6 months during this break period.

The study had an independent Study Steering Committee whose members included Amanda Amos (University of Edinburgh), Matt Egan (London School of Hygiene & Tropical Medicine), Chris Roberts (Welsh Government), David Humphreys (Oxford University), Sheila Duffy (ASH Scotland) and Ashley Gould (Public Health Wales). Amanda Amos chaired the group initially. All members declared no conflicts of interest at the first meeting, and were asked to declare any new conflicts at the start of each meeting. As Linda Bauld moved to University of Edinburgh in 2018 and remained a co-investigator on the study, this meant that a co-investigator was now in the same department as the chairperson. This new conflict of interest was declared to NIHR, which advised that Amanda Amos no longer met the criteria for independence and was, hence, no longer eligible to chair the committee. Matt Egan took over as chairperson. Sharon Cox (University College London) joined the committee at this stage as an additional independent member. The committee met approximately 6-monthly during the live study periods. Analyses reported in each journal article were presented to the group prior to submission. Our primary statistical analyses of long-term change in e-cigarette use were presented to the Study Steering Committee at a final meeting in November 2020.

Deviations from protocol

Our original protocol included an examination of social media mentions of e-cigarettes, including sites such as Facebook (URL: www.facebook.com; Meta Platforms, Inc., Menlo Park, CA, USA) and Twitter (URL: www.twitter.com; Twitter, Inc., San Francisco, CA, USA). However, our qualitative data indicated that the kinds of media covered by our proposed methods were less relevant to young people than other forms of media, particularly video-sharing websites, such as YouTube (URL: www.youtube.com; YouTube, LLC, San Bruno, CA, USA), which would not be captured by our proposed methods. Following discussion with our Study Steering Committee, this small element of the process evaluation was removed from our protocol. Owing to a miscommunication within the process evaluation subteam, in one nation, two observers each observed different premises rather than two observers per premises. Hence, inter-rater reliability assessments are based on two rather than three countries. Remaining variations from protocol largely related to data availability changes. We originally aimed to use SALSUS data from 2017 and 2019, assuming a typical 2-year cycle. However, the 2017 survey was postponed to 2018 and the 2019 survey did not take place. Our updated protocol indicated that we would seek to use data from the Scottish Health and Wellbeing census planned for 2019 if access could be negotiated; however, this also did not take place, with its launch postponed to 2021. In England, at the time of writing the protocol, funding was confirmed for the 2016 and 2018 SDDU surveys; however, with SDDU moving from an annual cycle to a biennial cycle, funding was being sought for 2017 and 2019 surveys. This funding was not obtained and, hence, the additional surveys we said that we would use if they were conducted were not. There were significant delays in the 2018 SDDU data reaching the UK data service. We sought to present all analyses to our Study Steering Committee prior to submitting for publication. At our final meeting in November 2020, we presented all analyses other than those requiring this data set, and were advised to submit the report without these analyses. However, the editorial team at NIHR asked us to wait until these were analyses available. As this final data set became available in only November 2021, the analyses using these data were finalised immediately before report submission in December 2021. Some intended subgroup analyses could not be conducted because of changes in survey methods. In England, for example, SES was measured by asking young people if they were entitled to free school meals until 2014; however, from 2016, SES was measured via the FAS.

Trajectories of young people’s smoking prevalence from 1998 to 2015

The analytical sample for smoking prevalence from 1998 to 2015 included 242,855 and 243,111 young people for ever and regular smoking, respectively. Table 3 presents percentages (and 95% CIs) for each outcome from 1998 to 2015, overall and for each country. In all countries, there was a consistent downwards trend over time in both outcomes. In 1998, most young people (around three in five) aged 13–15 years had tried smoking. Over the course of the time series, this declined to become a minority behaviour, with approximately one in five young people reporting having tried smoking in 2015. In 1998, approximately one in five young people reported being regular smokers across countries. Regular smoking fell to between 4% and 6% in each country by the last measurement point. For both ever and regular smoking, there was some evidence of decline beyond the ‘intervention’ point (i.e. from 2011 to 2015 when e-cigarette use was becoming more prevalent in the UK).

Table 4 shows odds ratios (ORs) and 95% CIs from segmented regression analyses for ever and regular smoking (for the whole sample and for gender and year group subgroups). In our a priori-specified models, which assumed a linear decline in smoking from 1998 to 2010, there was evidence of negative change in both level and post-slope terms after the intervention point for ever smoking. This change was consistent with a conclusion that ever smoking declined faster during the period when e-cigarettes were increasing in prevalence in the UK than it had been up to that point. However, visual inspection provided some evidence of non-linearity during the baseline period. Addition of a quadratic term confirmed that non-linearity was significant. Accounting for non-linearity led to a changed conclusion of no significant change in trend for ever smoking. For regular smoking, there was no evidence of change in trend in linear models, which is consistent with a conclusion of continued decline at the same rate as the secular trend. However, after adjusting for non-linearity of the baseline trend, a marginally significant (p = 0.03) slowing in rate of decline for regular smoking after the ‘intervention’ point was found. In both cases, significant reduction in level at the intervention point is evident. In a range of sensitivity analyses, ORs for change in trend for ever tobacco smoking ranged from 0.98 to 1.04, and were mostly non-significant, hence, providing little evidence of change in trend for ever use. ORs for change in trend for ever smoking post 2010 ranged from 0.99 to 1.11, with most ORs supporting a conclusion of a significant positive change in trend (see Report Supplementary Material 1, Table 1).

In subgroup analyses, the slowing of decline for regular smoking was limited to groups for whom rates had declined most rapidly up to 2010 (i.e. girls and 13-year-olds). Additional subgroup analyses by free school meal entitlement (limited to Scotland and England) indicated a marginally significant increase in rate of decline of ever smoking for young people with a higher SES (high SES: OR 0.95, 95% CI 0.91 to 1.00, p = 0.043; low SES: OR 1.01, 95% CI 0.91 to 1.12, p = 0.919). For both groups, change in trend for regular smoking was similar to the whole sample, falling short of significance in both instances (high SES: OR 1.03, 95% CI 0.88 to 1.21, p = 0.0.561; low SES: OR 1.03, 95% CI 0.94 to 1.11, p = 0.734). Country-specific analyses according to differing measures of SES are presented in Report Supplementary Material 1 data, but should be treated with caution given the small number of data points available for individual countries other than England (for additional subgroup analyses see Report Supplementary Material 1, Tables 2–6).

Specificity of change in trend: trajectories in ever alcohol and cannabis

To evaluate whether or not changes in trend were specific to smoking, we examined time, level and post-slope terms for the same period for ever alcohol and cannabis use. Table 5 presents percentages (and 95% CIs) of young people who reported having tried alcohol and cannabis by year and country. At first measurement in 1998, most young people reported that they had tried alcohol, declining in each country to approximately half by the end of the time series. Approximately one-quarter of young people in Scotland and England, and one-third of young people in Wales, reported having tried cannabis in 1998, declining to around 1 in 10 by the end of the time series.

As indicated in Table 6, in models assuming a linear baseline trend, there was evidence of a slight acceleration of the decline in alcohol use and no change in trend for cannabis use. However, as for tobacco use, adjusting for non-linearity of the secular trend altered trend estimates. For both alcohol and cannabis use, there was a significant positive change in trend, with the decline in both slowing after the ‘intervention’ point. This was consistent across subgroups. Hence, the slight disruption in trend for regular smoking was reflected, to a larger extent, in other substances for which e-cigarettes would not be expected to cause a change in trend. Both were measures of ‘ever’ use, whose counterpart measure for tobacco did not show evidence of change in trend, hence, suggesting that any slowing in decline for smoking was lagging behind change in trend for other substances. In a range of sensitivity analyses, ORs for change in trend for alcohol ranged from 1.05 to 1.16 and for cannabis ORs ranged from 1.05 to 1.24. The ORs were significant in all analyses, consistently indicating a significant positive change in trend (i.e. slowing in decline) for ever alcohol and cannabis use (see Report Supplementary Material, Table 1).

Plausibility of change occurring via renormalisation

Perceived similarities and differences between e-cigarettes and tobacco cigarettes

The term ‘e-cigarette’ was widely rejected by participants, with ‘vapes’ and ‘vaping’ generally preferred. Participants most commonly described ‘tank’- or ‘pen’-style devices as used by their age group, rather than ‘cig-a-like’ models. There was general awareness of how vapes functioned, including the need to charge them and the production of vapour rather than smoke. When asked why young people vaped, reasons included for fun with peer group, for flavours, and to show off to peers both in real life and online through posting tricks on social media. These, predominantly social, reasons contrasted with perceived reasons for adult use, described primarily as to stop smoking:

Like, you don’t see people our age going round with the ones that look like cigarettes ... Maybe adults would, the ones trying to get off smoking.

W2, 1, F

Several commonalities between vapes and tobacco cigarettes were described, such as potential addictiveness, nicotine content and potential to be harmful. Stated differences were more extensive, with non-nicotine e-liquid options and range of flavours most commonly referenced and vaping defined as different from smoking. Developments in technology, including styles of device and range of flavours, appeared to enhance differentiation from tobacco cigarettes.

In discussing perceived risks of vaping, there was much variation in responses within groups, with peers often disagreeing over risks or stating something that others were unfamiliar with leading to discussion over the validity of claims. Although smoking harms are taught in school from an early age, this was not the case for vaping, with no young people reporting that their school had covered e-cigarettes and frequent reference to getting information from social media. There was also notable variation in awareness of the legal age for vaping in the UK. Types of risks identified also often differed from risks of smoking, with health risks, such as cancers and respiratory conditions, less likely to be mentioned than for smoking. For vaping, risks commonly focused on anecdotes of operating or charging problems, such as devices ‘blowing up’, with young people frequently citing stories from social media and unknown toxicity of the chemicals in liquids. Although clearly viewed as less harmful than smoking by most young people, notions of ‘harming differently’ were evident:

Some people say they have even more ... they claim to be less harmful but actually they’re more harmful in fact, apparently.

W1, 4, F

Many young people expressed caution that harms may yet be discovered in the future, as had happened with smoking:

It’s just with e-cigarettes, you are not sure what’s bad about them. Like, you know some of them are nicotine. So it’s just, what health impacts? Smoking, you know that you can get lung cancer, but e-cigarettes there isn’t the same health issues.

S1, 2, F

Stakeholders’ views on tobacco control and the pros and cons of e-cigarettes

Interviews commenced with a discussion of tobacco control and direction of travel within the UK over recent decades, including drivers for sustained reductions in smoking and the emergence of e-cigarettes. There was consensus that success in reducing smoking was attributable to a wide-ranging package of measures, spanning pricing, advertising constraints and restrictions on locations where smoking is permitted. Many participants felt that these measures had facilitated a shift in cultural norms, with reduced exposure and access to tobacco among young people leading to stronger disapproval than in previous generations:

There’s been a shift in culture with regards to the acceptance of people who smoke and the acceptance of passive, being exposed to passive smoking. So we’ve had a huge shift in culture, which has led to the decrease, coupled with price increases, tax increases around cigarettes as well.

W2

However, impacts were frequently described as inequitable, and this led several stakeholders to suggest that future actions in smoking harms require more effective targeting of disadvantaged groups alongside general population measures:

We want to bring the rates down across the board, but we know we need to do more targeted action, where those rates are higher.

W1

In relation to the positioning of e-cigarettes, views were highly variable in terms of whether e-cigarettes constitute a positive or negative development for public health. All participants acknowledged limitations in the evidence on potential harms at the time of interview, with some participants suggesting that this impeded ability to provide clear guidance and communication to the public. Views of what this meant for practice, and the extent to which e-cigarettes should be accepted within public health, varied significantly. Many participants saw e-cigarettes as having a positive role in providing another smoking-cessation option with less harms than those known of for tobacco. It was suggested by some participants that the market-led provision of e-cigarettes was helpful in ease of access for smokers, for whom some current smoking-cessation options could be more difficult (e.g. where there was a requirement to engage with medical professionals). Concerns were expressed, however, that profit-driven provision meant that customers may not be getting clear and consistent advice on product use from retailers. Hence, some participants argued that it would be preferable for cessation advisors in statutory services to be trained to offer advice to those accessing their service. According to some participants, this would ensure positioning of e-cigarettes as a tool to transition away from nicotine rather than a long-term maintenance option:

Let’s get the right e cigarette with the right level of nicotine for the smoker. So that would mean training those vaping advisors, to make sure that people who are giving that, who are distributing this product, are aware of, if they smoke this, then they need to have this much nicotine, because getting the right amount of nicotine is so important in that smoking-cessation journey.

W2

There was greater caution observed from respondents in Wales in particular on whether or not e-cigarettes should be actively recommended by cessation services, perhaps reflecting wider national debates across the UK nations and historical caution in Wales at policy level. Many stakeholders noted this difference, with some stakeholders suggesting that Scotland and England were both more supportive of e-cigarettes within cessation services than Wales:

Int: How would you see that actually working in practise, should vaping be recommended [in smoking-cessation services]?

E5, res: So I think it’s a done deal in England I don’t think anybody would seriously doubt it and in Scotland as well. In Wales there’s a debate.

All interviewees expressed concerns over the potential harms of e-cigarettes for young people, with consensus that monitoring uptake by young people was a priority, although interviewees were aware that evidence at the time of interviews suggested that regular use by young people was rare. The concept of tobacco renormalisation was discussed as a potential result of the growth of e-cigarette use, and the views of interviewees were highly variable on how to address this. Although many interviewees suggested that there was little evidence of renormalisation to date, this was interpreted differently as either ‘evidence of absence’ or ‘absence of evidence’. Some interviewees argued that the evidence had shown that shifting norms of tobacco use among young people were unlikely to be reversed, whereas other interviewees stated that it may be too soon to know the full impacts of e-cigarette emergence on smoking norms. Despite these variations, policy measures aimed at restricting young people’s exposure to e-cigarettes, while facilitating availability to smokers, were widely supported:

I’m generally in favour of the regulatory approach that we’ve taken in the UK which does feel like a good attempt of getting that balance right between keeping them away from kids and having information around that they are not harmless but, making them available to try and have them deliver the potential they have.

S3

Barriers to and facilitators of implementation of the Tobacco Products Directive

The process of policy implementation was discussed, including the lead-in period to full compliance and the immediate communication and enforcement activities undertaken. Initial understanding of the new legislation and the changing requirements among retailers was described as limited in comparison with tobacco because of significantly more experience of tobacco as a restricted product. Several reasons were cited for this, including limited resourcing within public health bodies and local authorities to publicise the new regulations to all those selling e-cigarettes in their area. All TSOs discussed the impacts of funding cuts on their work, with some areas losing as many as 50% of their staff in recent years:

I’m the only officer in [this area]. I’ve got 700 premises to deal with approximately ... I think it is generally down to local authority budgets, more than anything. It unfortunately comes to money.

TS1, S

This was coupled with new and emerging threats, including illicit tobacco, modern slavery and criminal gang activity. For many respondents, the choice was between acting on these issues and the perceived lower risk activity of e-cigarette use. Despite funding constraints across all nations, TSOs were reported to have increased visits to retail premises in the period leading up to the implementation of TPD regulations and during the transitional phase. In Scotland, TSOs reported that ring-fenced funding had been made available from the Scottish Government to fund and increase visits to retail premises to observe and enforce the roll-out of TPD regulations; however, this differed in England and Wales, where money had been made available in some local authorities, but had been provided on a bespoke basis from local authority budgets. As TPD regulations came shortly after introduction of age of sale restrictions in England and Wales, pre-implementation checks often involved use of young people aged 18–20 years to check on retailer requests for proof of age (with this practice more common in recent years because of restrictions on the legal basis for test purchasing by under-age young people). Many TSOs favoured this approach as conducive to good relationships with retailers and were keen to stress that they did not see their role as ‘catching out’ those who may not yet have been fully aware of TPD requirements.

Across the nations, there was consensus that the funding provided during implementation was not sufficient for direct communication with the majority of retail outlets, partly because of the rapid growth of settings selling e-cigarettes in recent years. This meant that, where limited funding and staffing were a factor, what resources were available were used to communicate more with those involved in e-cigarette manufacturing and wholesale, as opposed to attempting to communicate with direct retailers. Views varied as to the effectiveness of this approach, with some respondents observing that under-resourcing of messaging and communication left many retailers reliant on trade bodies and suppliers to inform them of the changes they were required to make:

Unless there’s more detailed funding provided then we’re unlikely to do it really and I suppose you could say that work should be done by the manufacturers, because the responsibility is there anyhow isn’t it?

TS1, W

After the expiration of the 12-month implementation period, it was reported that e-cigarette sales compliance monitoring was incorporated into normal practice for TSOs, meaning that site inspections were generally initiated only in response to intelligence being received from the public on illicit activity. However, the rate of reported incidents for e-cigarettes was described as minimal in comparison with illicit sales of tobacco and alcohol, which were much more frequently reported by concerned parents, schools and other stakeholders:

... we do get under age sales for alcohol, there is more complaints about them. And in relation to e-cigarettes we have only had three complaints since 2016.

TS1, W

However, despite limited capacity to communicate and enforce the e-cigarette regulations, including TPD regulations, there was a general perception of retailer compliance as relatively high.

When discussing perceptions and reported incidents of non-compliance with regulations among retailers, in both policy and TSO stakeholder interviews, the nature of the retailers themselves was raised as a factor. Specialist e-cigarette retailers were felt to be more likely to be fully compliant because of the desire to maintain their businesses, better links with trade bodies and often larger scale of their parent companies. More issues were cited as associated with non-specialist, often smaller, retailers who may have had limited experience of selling age-restricted products. The absence of constraints on the types of retailers able to sell e-cigarettes, coupled with the speed of market growth, meant that some businesses with little or no experience of staff training on age restrictions or legal frameworks for sales were active in the e-cigarette market. In these premises, many interviewees felt that non-compliance was more frequent than among retailers who traditionally sold tobacco or alcohol:

You can get it in a shoe shop or you can get it in a boutique or a chemist. So they never had to bother about age restricted products before. A watch repairer, mobile phone shops. People who have never had to deal with age-restricted products are selling NVPs [nicotine vaping products] and it’s like, ‘I don’t ask anybody anything’.

TS2, S

Future policy direction and potential review

The departure of the UK from the EU means that the TPD regulations can be reviewed by the UK Government, with initial commitment to do so in 2021 at the time of interview. Respondents were asked to consider what this may mean for future work in tobacco and e-cigarette regulations and most respondents felt that the direction of UK policy would remain largely unchanged, with little expectation of divergence in major areas, from either the EU or within the UK. Several respondents suggested that the UK had often been the leader in driving regulatory changes on tobacco and that this was unlikely to be reversed in the future:

We’ve gone further than the EU on most things so our advertising, tobacco advertising directive we go further than that in what we prohibit in terms of advertising, promotion and sponsorship. So we don’t just prohibit cross border advertising, promotional sponsorship we prohibit all advertising promotions and sponsorship. So there’s no reason why leaving the EU would change because that’s all translated into UK regulation.

E2

It was noted, however, that the opportunity to review those elements of the TPD regulations with less supporting evidence could be a positive outcome, specifically in relation to restrictions on e-liquid sizes, message content on warning labels and tank sizes:

And actually we’ve got our doubts about whether or not implementation of [tank size restrictions] that is generally a good idea. So you know, going forward, that’s the kind of thing where we might say actually is it good evidence around that. And if not, then that might be something that we want to change.

E4

Furthermore, the capacity to develop and adapt legislation quickly in response to new and emerging products adaptations, such as additions to tanks and ‘short-fills’, was also cited as a potential option for the UK operating outside the EU. Overall, there was little concern about the direction of policy after Brexit and little indication that major divergence across the UK nations was occurring, or was likely to occur in the future.

Perceptions of the role of e-cigarette retailers

Many vaping specialists argued strongly that their role was to provide advice and guidance on vaping to help the public quit smoking. Many vaping specialists identified as former smokers who wanted to help others quit like they had. Some specialists argued that all retailers selling vaping products should have knowledge of the area and should be able to give advice regarding use and cessation, with some vaping specialists arguing that vapes should be sold only by specialists with knowledge and training:

I don’t agree that e-cigarettes should be sold in petrol stations, they shouldn’t be sold in supermarkets, obviously we’re dealing with lithium ion batteries, we are dealing with a toxic substance ... I do believe that they should only be sold somewhere where the person selling it has some sort of idea what they’re selling, some sort of training for the staff.

EVS4

Alongside emphasising their role in helping smokers to quit, retailers also emphasised a perceived responsibility to discourage non-smokers from taking up vaping:

... we will get the occasional, especially among younger people we’ll get people come in looking to vape and they don’t necessarily smoke. I mean we try to recommend that they don’t, it’s pointless taking up a habit if they haven’t got an addiction to nicotine already.

EVS4

In discussions of attitudes and policies towards under-age sales, all respondents stated that they would not sell vaping products to individuals aged <18 years. Retailers described being accustomed to asking for identification to verify age if they suspected that a customer was aged <18 years. Many retailers specified that they followed the challenge 25 policy, where if a customer looks under 25 years of age then they will be asked to prove they are aged >18 years:

You get the occasional ones that come in and go I’m eighteen, and I’ll be like well I’m sorry but you have to prove it to me, oh well, and away to storm out the shop, so you are not 18 then, and you are not getting back in, and they don’t come back because they know that they are not going to get served you know.

SVS4

Retailers reported mixed experience of minors showing interest in vaping products or attempting to buy from their stores. For some retailers it was a regular occurrence, but for others it was unusual or rare. Specialist retailers were more likely than non-specialists to mention interest in vaping products from minors:

Obviously you have to ID them first of all anyway, young people are not interested in vaping products, not at the moment.

SNVS4

Yes, we often get kids coming in just asking about the products and you know that they’re not old enough so we basically just have to kick them out and ask them to leave ... I mean sometimes there’s no point even asking for ID because you know they’re about 12 so we just ask them to leave.

EVS7

Some retailers described incidents of parents attempting to buy vaping products for their (underage) child and described it as their role to regulate this:

It’s more common we’ll get the parents come in with their child and try to buy it themselves for the child but even then if someone comes in with someone who we believe it’s being bought just for we’ll still ID them and if they can’t provide ID we don’t serve the parent even if one of them is of age.

EVS4

Several Scottish and Welsh retailers said that they used a refusals log to record attempts to buy products by those suspected to be aged <18 years. For one retailer, this included recording when a customer had been asked for ID and were able to verify that they were aged ≥18 years:

Yeah we, in both our shops we keep a log book, anybody which actually tries to purchase anything under 18, we give them the benefit of the doubt, ask for ID, if they haven’t got ID and the ones which are 18 and three-quarters, look 16, they’ve got their ID, yes that’s fine, but we write it in the book. So we keep a log of all the refusals and acceptance on that there.

WVS3

Views on the Tobacco Products Directive and the principle of regulating e-cigarettes

Views on the TPD varied extensively between specialist and non-specialist retailers. Non-specialist retailers were often broadly supportive or simply unaware of its existence. Specialist retailers were often critical of the TPD and its regulations on vaping, although many recognised the importance of certain regulations, and identified aspects they saw as important:

You know we reach our peak and then they knocked us back down again. So I don’t agree with any of it, I would like to keep hold of ... like I said child lock and stuff like that. I don’t think we should eradicate small bottles completely, because some people do want the small bottles you know. I just want the TPD to go away.

WVS2

Many specialist retailers acknowledged the importance of vaping being regulated, but called for vaping to have bespoke regulations, rather than regulation being aligned with tobacco:

They should be regulated one hundred per cent, all for that there, but it’s not a tobacco product, there’s actually not tobacco in it, so it’s not tobacco product, so they can’t be related to it. A hundred per cent got to be regulated, the Laws ... some are good and some are absolutely ridiculous.

WVS3

Many retailers challenged the logic of e-cigarettes being included within the TPD, as although the process of vaping mimicked the process of smoking, e-cigarettes were seen as different products with completely different purposes, with some retailers highlighting a popular movement away from the use of the word ‘cigarette’ within their description:

They should be dealt with as a separate entity. They should be, they are completely different. A lot of people are moving away from using the word electronic cigarette as well.

EVS2

Many retailers also expressed concern about a perceived risk that if regulated in similar ways, then vaping would be seen within public perceptions as the same as smoking, rather than as a less harmful tool for smoking cessation. Specialist retailers were often keen to avoid being labelled as tobacconists, describing their role as operating in opposition to tobacco, and distancing themselves from the stigma of smoking:

I think there needs to be separate regulations for it because I think it sort of almost wants to steamroller into it that it’s like smoking. It’s like we had directory services call us up and say would you be happy for us to put you down as a tobacconist and I was like well I’m not really comfortable with that because we don’t sell tobacco you know we don’t have the use of cigarettes or smoking and that so we don’t what that sort of stigma to be attached because that’s not what we’re about. We want people to be healthier by quitting smoking and using this as a replacement for the nicotine.

EVS5

However, some non-vaping specialist retailers thought that vaping and smoking should be regulated together, with one retailer commenting that smoking and vaping were essentially the same thing:

At the end of the day you are talking, some of the lines have got nicotine in them and you are weaning yourself down on it, we all know that. But it’s exactly the same thing, it is basically six and one, and half a dozen of the other isn’t it?

WNVS3

Specialist retailers expressed concern that future changes in the regulations on vaping may lead to significant negative impacts, with some anxieties appearing not to be about the TPD specifically, but whether or not the TPD would act as a beginning of an escalation of regulations:

I don’t know they haven’t thought it through, I think there’s going to be more regulations soon and it’s going to mess everything up.

EVS7

Say the TPD decided to change their minds tomorrow and say well double battery mods are now banned. I’m automatically breaking the law just by having this. I’ll have to get rid of loads of stock, the suppliers will have to take a massive hit. So changing rules willy nilly like that is kind of annoying ... Keep it away from kids and get people off cigarettes, it’s as simple as that.

WVS4

Some specialists, although initially unhappy with the TPD, were keen to see no further changes to juices, tanks or bottles now that the regulations had been implemented. Achieving compliance was described as causing a financial burden, which would be wasted if this was reversed, particularly for smaller companies that were described as having struggled to bear additional costs of complying with regulations:

The annoying thing about it is, this regulation came from the EU, we are coming out of the EU but are they going to back track? No, and I hope they don’t because the industry has spent millions of pounds regulating all of these because each flavour has to be put through a process, so say one supplier, one brand has 10 flavours right, each flavour has to get put through this TPD process, minimum of 3000 pounds per flavour, so a lot of wee guys were wiped out.

SVS4

Specialist retailers commonly expressed strong suspicion regarding the motivations that drove the inclusion of vaping in TPD. Some specialist retailers argued that there was a perception among the vaping industry that tobacco companies had a prominent role in influencing the legislation regarding vaping and that it was an attempt to sabotage the industry:

I think it’s, it seems like a lot of people thought it was like big tobacco companies influencing government to stop, well at least cutting the amount of, because in the first year, I hit like a brick and managed to get loads of people onboard, and I noticed everyone was vaping where I was living, no one was smoking anymore, and then the second all these regulations came in and made it a lot harder for people to do stuff, it died out a little bit and people went back to smoking. Now I thought it was to do with the tobacco, the reason why the rules came in...

EVS1

Specialist retailers also described how, initially, tobacco companies had been opposed to vaping and influenced negative media campaigns and lobbied governments. However, this was believed to have altered over time, with tobacco companies investing in vaping products:

Tobacco companies were very against vaping to begin with. There was a lot of scaremongering that was released in the press about vaping and that was mainly from tobacco companies and stuff like that. But now some of them are on board because they realise there’s a market for them.

WVS2

Some specialist retailers were also suspicious of UK and European governments and regulators and what was described by some retailers as attempts to derail the vaping industry:

In terms of regulators, I suspect there was a misunderstanding of the science, possibly some deliberate. I’m sure there’s some influence from pharmaceutical industry. I think there were some memos released which talked about the need to put regulation on a product which is a competitor to nicotine ... and really not giving many of the scientists involved in the EU who will be researching electronic cigarettes the opportunity to speak up I think. Derail the vaping industry.

WVS5

Obtaining information and support for implementation of the new regulations

Knowledge of the new regulations around e-cigarettes and vaping devices in the TPD was variable between specialist and non-specialist retailers. Specialist retailers generally possessed a more comprehensive knowledge of the regulations, whereas non-specialist retailers demonstrated a much more limited understanding. In some cases, this was highlighted by the lack of distinction retailers made between regulations around tobacco control and regulations relating to vaping devices:

I appreciate that writing the TPD at the time was probably quite a tough task because, you know, they were ... they were trying to write a set of rules on an industry that was moving so quickly. By the time that it actually came to fruition, came to become statute, it ... it was so outdated it was quite hard to sort of perceive.

WVS6

Int: In terms of the warnings displayed on the e-cigarette packaging, what do you think about that?

WNVS2: It’s good because it lets people know that you are still buying a tobacco product. So that takes that, it’s trendy away, there is not pictures of dragons and stuff, there are pictures of people that are ill because of tobacco.

Despite absence of a detailed knowledge, most non-specialist retailers described access to support from other knowledgeable sources where advice was needed. Retailers who worked for companies involving multiple stores described relying on guidance from within their wider organisation, whereas other retailers described having been advised about regulations by sales representatives, sometimes described as linked to tobacco companies:

There are so many regulations ... I just depend on the advice that comes in from the reps and that’s it really.

SNVS4

Specialist vaping retailers generally reported that they had received no official advice or support to help them implement the TPD regulations, but that they or others they worked with had actively sought information on the regulations, with a variety of sources mentioned. Some retailers said that they had obtained information from discussions within the vaping community, via online forums or events, or had spoken with other vaping retailers or suppliers:

We just knew it was coming in and the reason why we were updated was because we would attend [event] which obviously, vapers from all over the world and stuff like that and that is the only way we got informed. Because the next show was going to be TPD, so everyone was freaking out and we didn’t know what was what so we went around and got a source and we found out from other people what they had been told.

WVS2

Other retailers noted that their main source of information was from within their company, with guidance handed down to stores that operated as a part of a chain. In some cases, knowledge of the regulations had been gathered from company owners who reported participating in processes related to the development of the regulations:

We’ve been involved in consultations, we’ve been to some of the parliamentary groups, we’ve read through the regulations, we discuss it in the industry and in institute groups, so it’s a multiple, gathering from multiple sources.

WVS5

Some retailers mentioned that they sought information and support from government sources, including official information online and local trading standards teams. Views on the value of these information sources, where provided, were generally negative. One specialist retailer suggested that some of the language used on government websites was confusing, and had increased anxieties by making changes within the TPD regulations appear more challenging than they were in reality:

I think everybody saw it coming in as this big black cloud and little bits off the government website, reviewers and stuff like that, they were talking about it, where until it came into play, it sounded bad, it sounded like you could potentially kill the industry off completely. And then the further and further we got into it, it sort of, you go, well it wasn’t, it’s not that bad, or as you were reading something on the government website, you think about it, and you go, it didn’t actually mean what it looks like it means ... they word it so awkwardly that it confuses you after six letters into a word, it’s yeah, it was, it was panic stations...

WVS7

Specialist retailers who sought information from local trading standards departments perceived that officials sometimes lacked the necessary knowledge themselves to be able to provide advice:

I thought someone would come around and tell us about it but actually the cigarettes [e-cigarettes] themselves, they were constantly changing so you just had to learn about it yourself ... they [trading standards officials] were asking us questions, ... originally I phoned trading standards in [Scottish local authority], she came out and obviously she wasn’t sure.

SVS2

Perhaps as a consequence of these limited communications, retailers argued that a great deal of uncertainty remained in the period before TPD implementation:

When the TPD first came round I was going through legislation and finding things that we were never told, like the sort of things we could sell and couldn’t sell which we had on the shelves like 2 days prior that we intended to keep selling so. No one ever really came round and went look this is what you’ve got to adhere to and so it was a bit of a mess to be honest.

EVS4

Uncertainties also appeared to persist for some specialist retailers in relation to what advertising and marketing of vaping products was permissible under the TPD:

Yeah, this is what you can do, so like there’s so many different rules and regulations like I can’t, it used to be but I’m not sure now, but I couldn’t display prices outside the store or on products on the shelf. I can display it on a separate sheet. I’d have to triple check that but it used to be something like that, that I couldn’t display prices outside that’s with stuff that contains nicotine. Now I think that possibly might have changed again.

EVS2

Compliance and enforcement

Perceived unintended consequences of the Tobacco Products Directive

Perceived impacts on smokers and young people

The TPD regulations and the possibility of future tighter restrictions were considered by many specialist retailers to reduce cessation opportunities and were likely to lead to people going back to smoking:

Well if they can make it really awkward and inconvenient for vapers to vape, we will go back to smoking cigarettes again, so if they take away all the flavours which they wanted to originally, taking away the bigger tanks that they keep talking about, they’ve taken away the stronger nicotine...

WVS3

There was a perception among some retailers that there was a particular problem with compliance on the internet. The regulation of traditional sales and young people’s growing reliance on social media were seen as potentially interacting to displace sales of vaping products to minors onto the internet, where devices were likely to be cheaper but unregulated:

Young people generally access most things through social media, so as soon as they’re part of these groups it’s bang, it’s in their face all the time ... So, the availability of products through social media ... that are (a) unregulated products, and (b) become even cheaper through that is an issue, definitely. The problem that that has is there are certain parts of the ... certain parts of the market, the products could be quite dangerous if they’re not used properly.

WVS6

Changes in perceived prevalence and norms for e-cigarette use

In 2017, a large majority of young people across all groups had stated that e-cigarette use had recently risen rapidly among their age group and was now perceived as more common than tobacco smoking. Experimental use of e-cigarettes was widely viewed as unproblematic. Trying an e-cigarette was driven by various factors, including sharing with peers, fun and the appeal of flavours:

Yeah and you can get them like scented and stuff like that and so it entices young people.

W1(2)F

I just liked the different flavours. ’Cos my friend had jam donut, another friend had gummy bear flavour and Heisenberg which is a minty flavour which is quite nice.

S1(1)M

However, regular e-cigarette use was judged negatively. When asked to consider who regular users were among their school cohort, some young people felt that regular users came from the same groups as smokers, characterised as ‘outsiders’ or disengaged young people. Although experimentation with e-cigarettes was very evident, it was also a discussion point in many groups that this behaviour was a trend that seemed to have peaked and was likely to decrease among their cohort going forward:

Like the fidget spinners, and then I think as soon as fidget spinners die it’s going to be the same kind of, ‘Oh why are you still using them?’ kind of approach, the same as vaping.

E1(1)M

To explore this perceived peak in use, perceptions of prevalence were discussed in repeat interviews with young people in 2018. The repeat interviews appeared to confirm initial indications of e-cigarettes as a ‘fad’ that had peaked, with young people losing interest over time:

... you’ll see things of it occasionally but I don’t see anyone doing it just to show off now, any more.

W1(2)M

E-cigarettes were now described as being more commonly used by young adults who were using them to quit smoking. However, some interviewees argued that young people younger than themselves were still attracted by flavours and features that had drawn interviewees to try them previously. In 2018, approval of e-cigarette use was more variable than in 2017, with increased likelihood of peer censure associated with e-cigarettes being seen as an outdated fad:

They just go – [mocking tone] I’ve got a vape, I’m sick, look at me!

E4(3)F

I know some of the kids in our year they’re like, oh they just made jokes about it, oh you’re vaping, and think it’s a bit chavvy, and some, they think it’s cool.

W4(1)F

When initially discussing reasons for e-cigarette use in 2017, very few interviewees cited quitting smoking as a driver for young people’s e-cigarette use. However, in the 2018 follow-up interviews, cessation was often cited as a reason for young people using e-cigarettes. Regular use of e-cigarettes as a cessation aid was largely approved of, as opposed to regular use of e-cigarettes in non-smokers:

I think that if it’s used to actually try and give up smoking then I see a huge advantage to it, but obviously if you’re videoing yourself doing tricks and stuff that’s not trying to give it up [smoking], is it?

W3(2)F

Perceived family and peer reactions to e-cigarette use

At both time points, most participants reported that their parents would strongly disapprove of them using e-cigarettes or tobacco, with almost all participants suggesting that they would anticipate a worse parental reaction to tobacco. Some interpreted this as parental fear of tobacco being more clearly associated with moving on to other substances such as cannabis, while others suggested it being due to harms of smoking being better known than for vaping:

My parents would not be happy. Because they know the damage it does to your body ... My mum’s a nurse and she knows all about it, and it wouldn’t be very approved of in my family.

W3(2)F

In 2017, young people described some expectation of negative peer reaction to both smoking and e-cigarette use, but at lower levels than that expected from parents. Most young people suggested that peers would be more likely to censure smoking than use of e-cigarettes. In 2018, some young people expressed a general decrease in disapproval of ‘social’ smoking relative to their previous year in school, associated with maturation, although disapproval of regular smoking remained strong:

I think it is more socially accepted like, now, like in our year to smoke than it was last year. Like you see a lot more people smoking than before especially at parties.

E1(1)M

Survey data from Wales in 2017 and 2019 concurred with perceptions of high perceived parental disapproval of tobacco and e-cigarettes, with stronger disapproval of tobacco than e-cigarettes. Among young people who did not report current use of tobacco or e-cigarettes, a clear majority said that if they were to start, then their parents would try to stop them. At both time points, young people were more likely to report that their parents would try to stop them smoking than try to stop them using e-cigarettes, with a larger proportion of young people saying that their parents would try and persuade them to stop using e-cigarettes (see Figure 3).

FIGURE 3.

Percentage of non-smoking/non-vaping 13- to 15-year-olds reporting that were they to take up smoking/vaping then their parents would try to stop them or persuade them to stop. The question was asked of a random subsample of young people in the 2017/19 SHRN surveys (2017, n = 11,442; 2019, n = 11,197; smoking, n = 8535; vaping, n = 8329).

Among young people who reported current use of tobacco or e-cigarettes, half reported that their parents did not know. Among young people whose parents did know about their smoking or vaping, most reported that their parents’ either tried to stop them or tried to persuade them to stop (see Figure 4).

FIGURE 4.

Percentage of current users of e-cigarettes and tobacco reporting parental responses to their use. The question was asked of of a random subsample of current users in the 2017/19 SHRN surveys (2017, n = 989/993; 2019, n = 744/706, repectively).

Risk perception

In 2017, increased visibility of e-cigarettes in recent years had been widely cited as instrumental in increasing acceptability of e-cigarettes and reducing risk perceptions. Nevertheless, young people frequently cited mechanical risks (e.g. malfunctioning devices), potentially dangerous ingredients in liquids and, most commonly, as-yet unidentified harms:

Because they know what’s in the cigarette, like in tobacco cigarettes but they don’t know what’s fully in the e-cigarettes or the vapes.

W2(3)M

In both rounds of qualitative interviews, mechanical risks and unknown harms were commonly referenced. In 2017, addiction to nicotine was also mentioned in around two-thirds of groups as a risk of e-cigarette use. However, in 2018, addiction was less frequently mentioned. Many young people who had used e-cigarettes said that they were unsure if it had contained nicotine or not, with use driven by flavour rather than nicotine.

The SHRN survey data indicated that in both 2017 and 2019 a minority of young people who had tried e-cigarettes reported that the last e-cigarettes they used contained nicotine (see Figure 5). At both time points, around one in seven young reported not knowing what was in the last e-cigarette they used (14% in 2017 vs. 13% in 2019). Survey data also indicated changing views on relative harms of tobacco and e-cigarettes during this time. In 2017, approximately one in three young people reported that e-cigarettes were as harmful to health as tobacco, whereas almost half reported that tobacco cigarettes were worse (of the remaining young people, 3% reported that e-cigarettes were worse and 14% said that they did not know). In 2019, almost half of young people reported that e-cigarettes were as harmful to health as tobacco cigarettes, whereas approximately one-third reported that tobacco cigarettes were worse (of the remaining young people, 5% reported that e-cigarettes were worse and 13% said that they did not know).

FIGURE 5.

Percentage of current e-cigarette users’ (n = 8887/2880) reporting whether or not their last e-cigarette contained nicotine, and all young people’s (n = 12,824/9481) perceived relative harmfulness of tobacco and e-cigarettes in Wales in 2017 and 2019, respectively.

Availability of e-cigarettes

In 2017, most young people agreed that they would find it easier to obtain e-cigarettes than tobacco cigarettes, with few young people suggesting that both were equally obtainable:

But, like, e-cigarettes, it seems to be that you can get hold of one quite easily. But cigarettes – you have to like, know somebody who’s old enough to go buy you some.

S1(2)F

For most interviewees who had tried an e-cigarette, this had been through an informal supply route (e.g. a friend at a social event), although some interviewees reported awareness of someone at school who had bulk bought online with the intention to sell them on:

I was also one of the people who were making profit from them, people would ask me could you order one for me, and I was like OK well I’ll order them. I’d order 10 at once.

E1(1)M

Few interviewees stated that e-cigarettes were available through retailers. Qualitative data indicated that when purchased face to face, this was through shops known locally to be willing to sell illicit products, rather than via specialist vape shops:

Like I’ve seen down in X market, they sell to someone who was 9.

W2(3)M

Discussions a year later suggested that the landscape of obtaining e-cigarettes had changed. Many young people still felt that they could obtain e-cigarettes if desired, mostly through older peers or online purchase, but it was seen as more challenging to buy through school supply chains. This was associated with a perception of decreased use, which meant that fewer people were now selling e-cigarettes:

Int: Do you think it’s got easier or harder to get hold of vapes?

W1(1)M: I think it’s a bit harder because you don’t really see that many people do it anymore.

Int: ... people selling them, would that go on in school or after school?

W1(1)M: I don’t think it’s much in school. I know some people used to do it [sell vapes], but I don’t know anyone now who does it.

In 2018, tobacco was viewed as being as easy to obtain as e-cigarettes. This was attributed to factors such as increased age, which meant greater likelihood of having older peers or appearing old enough to self-purchase in shops, and also to increased smoking prevalence in the year group and, hence, a larger number of people to obtain tobacco from if desired. A significant number of young people were aware of someone at school who sold individual cigarettes, making cigarettes an affordable option:

I know in school obviously a lot of people do it in the corner, but some people sell them individually for 50 pence or maybe a £1 or something, and people do pay that money for them individually.

W3(2)F

Quantitative data from Wales (items included in only the 2017 survey) concurred with the view that most young people who used e-cigarettes obtained the e-cigarettes via means other than a retailer, with the most commonly reported supply route used being peers (see Figure 6). Approximately one-third of young people reported buying e-cigarettes from, or being given e-cigarettes by, peers. The next most commonly selected option was ‘some other way’, not captured by our response options, followed by obtaining e-cigarettes via adults. Fewer than one in six young people reported purchasing e-cigarettes from shops, with approximately 7% reporting buying e-cigarettes via the internet. Among young people who reported online purchase, approximately one in three (n = 29, 35.0%) reported that they had changed where they purchased e-cigarettes from in the past 6 months.

FIGURE 6.

The percentage of current e-cigarette-using young people reporting obtaining e-cigarettes via each supply route. The question was asked of a random sample of young people who reported having used an e-cigarette more than once: 2017 SHRN survey only (n = 3313).

Exposure to warning information and e-cigarette marketing

The TPD introduced a mandated warning, stating ‘this product contains nicotine, which is a highly addictive substance’. In 2017, recognition of this warning among interviewees was low. In 2018, recognition slightly increased, although remained limited, with young people continuing to indicate limited exposure to e-cigarettes within their packaging:

Int: Have you seen any warnings on vape packets?

E4(1)F: No. Can you even get vape packets?

When asked to discuss the current warning, a large majority of young people suggested that it would likely be ineffective at discouraging e-cigarette use among their age group. Young people commonly assessed the warning in relation to more graphic and more well-known visuals present on tobacco packaging, deeming e-cigarette warnings mild by comparison:

Like if I was vaping and like I was like ‘oh it’s fine because look at how bad cigarettes were, like I’m fine’, because there’s no health warnings on any of the [e-cigarette] packets.

S2(2)F

Brand awareness among young people was very low across both rounds of interviews. The most commonly reported avenue for seeing adverts in 2017 was vape shops, followed by online sources (i.e. streamed videos of e-cigarette users performing tricks). Exposure to advertising in public spaces, such as billboards, was seen as relatively common. In the 2018 interviews, however, few young people reported seeing any e-cigarette advertising.

Contrasting with these reports, approximately two-thirds of young people in SHRN surveys in Wales in both 2017 and 2019 reported exposure to at least one form of e-cigarette advertising in the past month. The most common location in which young people reported seeing advertising for e-cigarettes was in shops, followed by exposure to advertising on the internet. However, consistent with qualitative data on of reduced online engagement with e-cigarette-related material, the percentage of young people reporting internet-based advertising exposure declined from 39% to 34% by 2019. There were small increases in exposure to advertising on buses or in bus shelters (see Figure 7).

FIGURE 7.

Percentage of young people reporting having seen adverts in each location in the past month in 2017 and 2019. The question was asked of a random sample of participants in the SHRN surveys (n = 13,503/10,109).

Descriptive cross country comparison of changes in young people’s use of e-cigarettes

Figure 8 provides a descriptive overview of the percentage of ever and regular users of e-cigarettes over time, by country, between 2013 and 2019. The black line indicates the beginning of the intervention period (i.e. TPD implementation).

FIGURE 8.

Percentage of 13- to 15-year-olds reporting ever and regular use of e-cigarettes by year and country from 1998 to 2019. The black bars represent the beginning of one ‘intervention’ period (i.e. the introduction of TPD).

In Wales and Scotland, a near doubling in prevalence of ever use of e-cigarettes is evident in pre-TPD surveys from 2013 to 2015, with growth from 16% to 30% in Wales and from 12% to 23% in Scotland. In Wales, where post-TPD data are available from both the 2017 and 2019 surveys, a smaller continued growth was observed from 2015 to 2017, with ever use reaching 35% by 2017, followed by a marginal decline from 2017 to 2019 to 32%. In Scotland, where only one post-TPD survey was available, a slight increase in prevalence of ever use of e-cigarettes was observed in 2018 (25%) relative to 2015. In England, the first measurement was in 2014, at which point 27% of young people reported having tried an e-cigarette, and this rose to 33% by the 2016 survey (conducted marginally after the implementation of TPD), with no further growth after this time point. Hence, in all nations, there was evidence of rapid growth in ever use in the years leading up to the TPD regulations, with plateauing or marginal decline after the intervention point. Similarly, for the percentage of young people reporting regular use (i.e. at least weekly use) of e-cigarettes, all data sets provided evidence of some growth in the period prior to the TPD regulations, but with plateauing or marginal decline between the two most recent survey periods.

Change in e-cigarette use by country

Section 1: group guidelines

Because this is a group discussion I’d like to go over how this can work best. You’re not expected to all have the same opinions so feel free to disagree (politely!), there are no right or wrong answers during the discussion. Don’t feel like you have to answer directly to me all the time, you can answer each other’s points as well. My role is to ask the questions and to try to make sure that everyone can join in. If you don’t want to answer a question that’s OK.

To make it a clear recording and a better discussion, I’ll ask you to speak one at a time and allow whoever is speaking to finish their point. If you want to respond to someone else’s point, either to agree, disagree or add something else, please feel free to do this once they’ve finished. I might also write notes while we’re talking to remember things that I want to follow up on.

Ice breaker task?

Now, I’d like you to name all the words you use for these devices so that we can make sure we’re all clear on different language we might hear (brief group shout out of terminology). (Show images of cigarette-style and vaping devices and read out definitions. Include shisha devices.)

What word would you prefer to use to include all of these? In what ways do you think e-cigarettes (or chosen wording) are similar to tobacco cigarettes? How are they different? (Do they contain nicotine?)

Section 1: research theme – social norms of e-cigarette use in relation to tobacco and as a standalone product

1. How common is it for you to see people using e-cigarettes around the place now?

2. How many adults in your area do you think use e-cigarettes? (Prompt for estimate. ) Do you think this is more or less than the number who use tobacco cigarettes? Compared to when you started secondary school, do you think the number of adults using e-cigarettes has gone up or down? How about tobacco cigarettes?

3. How many people your age in your area do you think use e-cigarettes? (Prompt for estimate. ) Do you think this is more or less than the number who use tobacco cigarettes? Compared to when you started secondary school, do you think the number of young people using e-cigarettes is going up or down? How about tobacco cigarettes?

4. Why do you think young people might use e-cigs instead of smoking? (Prompt: using to quit, social reasons?)

5. What types of young people do you think use e-cigs? Are they the same kinds of young people that smoke tobacco? (Prompt: how are they similar? How are they different?)

6. Why do you think young people who smoke might carry on doing this rather than vaping?

7. Do you think you’ll use e-cigs when you’re older? Reasons either way.

8. What do you think your friends would say or do if you starting using e-cigs?

9. What do you think your parents would say or do if you were using e-cigs? (Prompts: be angry, try to stop you, be OK?) Why?

10. What about if you were smoking tobacco? (Prompt: as above on parents and peers views. )

Section 2: research theme – interaction with, and awareness of, e-cigarette marketing

1. Do you know the law on who can buy e-cigarettes?

2. Can you get hold of e-cigarettes if you want them? Where have you seen them on sale? (If yes, prompt on whether this means buying them or obtaining from someone else. )

3. Do you think you’d find it easier to get hold of (a) e-cigarettes or (b) tobacco?

4. Have you seen any adverts for e-cigarettes? Where? (Prompt: on public spaces, social online spaces, mainstream media, event sponsorship?) Do you remember the brands?

5. Who do you think the adverts were aimed at? (Prompt: adults, young people, current users/non-users?)

6. What do you think it is about them that would make them appeal to that group?

Section 3: research theme – perceived risk of e-cigarettes and interpretation of health warnings

1. (If positive in response to section 1, questions 1 and 3.) You said earlier that you thought more people your age were using e-cigarettes now than before. Do you think this might have any effect on the way e-cigarettes are seen by:

   1. young people your age?

   2. younger children?

2. What about the way tobacco cigarettes are seen by:

   1. people your age?

   2. younger children?

3. Are e-cigarettes safe? (Prompt here on perceived risk relative to tobacco: more or less safe?)

4. Do you think e-cigarettes have any risks to health? How and why? (Prompt here on nicotine content, ingredients, addictiveness?)

5. Have you seen any warnings on packaging for e-cigs? What do you remember?

6. (Use visual examples of types of warnings now on e-cigarette packets. ) What impact do you think health warnings like this might have on people your age? (Prompt: smokers and non-smokers?)

7. (Next show examples of warnings on tobacco packets and explore the same thing. ) Do you think e-cigarette products should have more warnings? Why or why not? What should they be about?

Closure

That’s all the questions I have. We’ve covered a lot of issues and I appreciate your patience, but is there anything else you would like to add? Do you have any questions about the interview or the research as a whole? Please feel free to contact me by e-mail if you have any queries at a later date. I’ll be in touch again in the next school year so that we can talk again.

Thanks again for your time and your contribution to the project.

Section 1: job role

1. First, could you tell me about your job role? (Involvement in tobacco control. )

2. How long have you been in this role?

3. How would you like it defined in the research?

Section 2: approaches to tobacco control

I’d like to start by discussing tobacco control more broadly and then moving on specifically to TPD a bit later. First:

1. What do you think have been the key influences on reductions in adult smoking over recent years?

2. What about for young people? Have the same factors been important or are there differences?

3. Do you think policy actions on youth smoking have had varied impact by demographic groups? And why?

4. Tobacco control policy has been increasingly devolved across the nations: positive or negative? Why?

Section 3: e-cigarettes

E-cigarette use has grown rapidly in recent years. Overall, do you think e-cigarettes have made a positive or negative contribution to public health, or do you think it’s not made any difference?

1. Why is that?

2. We know opinions are split on whether e-cigarettes should be recommended as a stop smoking tool. What do you think? (Why?)

3. What should regulation on e-cigarettes aim to do? Any additional measures you’d like to see in place on e-cigarettes?

4. E-cigarette regulation varies a lot internationally. Do you think the balance of e-cigarette regulation overall is about right? Too liberal? Too restrictive? Why?

5. Many policy concerns centre around young people and potential for nicotine addiction. What are your views on that?

6. Other concerns are that e-cigarette use mimics smoking behaviour and so will lead young people to see smoking as ‘normal’ again. What do you think?

Section 3a: Tobacco Products Directive theory

I’d like to talk more specifically now about the Tobacco Products Directive (TPD) legislation.

1. What do you think is good or bad about the changes introduced by TPD? (Prompt on why for each point made. )

2. How do you think these fit with the wider tobacco control agendas that we discussed earlier?

3. Looking down the line, how will we know if TPD has been effective?

4. Do you think there might be any unintended harms from TPD? What?

Section 3b: Tobacco Products Directive implementation

1. How was TPD communicated to the public? Has this been effective?

2. What do you think has already changed since TPD came in?

   1. What do you think of the warnings displayed on e-cigarette packaging as a result of TPD?

   2. Do you think these are expressed the right way? Why?

   3. Do you think these warnings might change the way people see e-cigarettes? In what ways?

Section 4: future directions

1. What do you think the next few years hold for e-cigarette regulation here?

2. And what about for tobacco control policy over the next few years?

3. We mentioned devolution earlier, do you expect any more policy divergence across the UK nations in the next few years?

   1. TPD is EU regulation. Going forward, do you think Brexit might present any challenges (or opportunities) in relation to:

   2. tobacco policy

   3. e-cigarette policy.

Section 1: introduction and context

I’d like to start by explaining the aims of the project. This research looks at the impact of regulation of e-cigarettes via the Tobacco Products Directive, introduced in May 2016. We’re talking to young people and policy stakeholders about this as well. Your job role means that you can make a valuable contribution to understanding on this topic.

1. First, how long have you been in this role?

2. What are your main duties?

3. What area do you work across?

4. Do you work with any other organisations as part of your role? Who?

Section 2: approaches to tobacco control

Smoking rates have been in decline for some years now in the UK and there have been major changes to tobacco control policy over the years. I’d like to discuss your views on this.

1. What kinds of changes have you seen in people’s smoking in recent years?

   1. Have you noticed any changes among adults in particular?

   2. What about young people?

   3. How has this impacted your role? (Prompts: changes to required enforcement, focus on different age groups or problems like illegal tobacco. )

2. What do you think have been the key influences on reductions in adult smoking over recent years?

   1. What about influences on reductions in youth smoking?

3. How do you think tobacco control policies have contributed to this?

   1. And how has policy change led to any changes in your role?

4. What other social changes do you think have contributed?

Section 3: e-cigarettes

1. Since the emergence of e-cigarettes, use has grown rapidly in recent years. What has that meant for your role, if anything?

2. To what extent do you think e-cigarettes should be regulated (a) in line with tobacco cigarettes and (b) as a distinct product? Why? What should regulation on e-cigarettes aim to do? (Prompt on: restricting availability of devices and/or liquids; providing health information; stopping youth uptake. )

3. E-cigarette regulation varies a lot internationally. Do you think the balance of e-cigarette regulation overall in Wales/Scotland/England is about right? Too liberal? Too restrictive? Why?

4. Overall, do you think e-cigarettes have made a positive or negative contribution to public health, or do you think it’s not made any difference?

5. Why is that?

Section 4: I’d like to talk more specifically now about the Tobacco Products Directive legislation

1. What do you think is good or bad about the changes introduced by TPD? (Prompt on why for each point made. )

2. TPD was introduced in May 2016 with a transitional 12-month period:

   1. What actions were taken in preparation prior to May 2016? (Prompt on: communication, enforcement, planning. )

   2. What type of information/support did you receive about TPD?

   3. What actions were you taking during the transitional period?

   4. And what happened after May 2017 (end of transitional period)? How did your actions change?

3. And thinking about now, are there any actions still going on that are related to TPD?

4. How has TPD been communicated to the public? Has this been effective?

5. What were your observations from visits to retailers? OR What did your staff report from visits to retailers? (Dependent on interviewee role. )

   1. Did compliance vary by type of retailer?

   2. What type of actions were taken/can be taken for non-compliance?

   3. What do you think the challenges are for retailers in being complaint?

   4. What do you think the challenges are for Trading Standards in enforcing TPD?

6. How do you think TPD fits with the wider tobacco control agendas that we discussed earlier?

7. How will we know if TPD has been effective? What would change? (Prompt here on both youth and adult behaviour. )

8. Do you think there might be any unintended harms from TPD? What might they be?

Section 1: introduction and retail context

I’d like to start by explaining the aims of the project. This research looks at the impact of regulation of e-cigarettes via the Tobacco Products Directive, introduced in May 2016. We’re talking to young people and policy stakeholders about this as well. Your job role means that you can make a valuable contribution to understanding on this topic.

1. First, could you tell me about the business and your job here?

2. How long have you been in this role?

3. Is the store(s) you work in part of bigger chain or independent?

4. Customer base: who buys e-cigarettes in this store?

   1. What kind of age group comes here most?

   2. Do you think most people who just vape are ex-smokers?

   3. Do many of your customers just vape now?

5. What do you think is appealing about e-cigarettes for your customers? (Prompt for function, flavours, branding, design, etc., and whether more or less appealing for younger and older customers?)

   1. Do you have any experience dealing with minors trying to buy e-cigarettes in your shop?

6. What are the regulations on this?

   1. Are there specific store policies for this?

Section 2: approaches to tobacco control

Smoking rates have been in decline for some years now in the UK and there have been major changes to tobacco control policy over the years. I’d like to discuss your views on this.

1. What kinds of changes have you seen in people’s smoking in recent years?

   1. Have you noticed any changes among adults in particular?

   2. What about young people?

2. What do you think have been the key influences on reductions in adult smoking over recent years?

   1. What about influences on reductions in youth smoking?

3. How do you think tobacco control policies have contributed to this? What other social changes do you think have contributed to these?

Section 3: e-cigarettes

1. E-cigarette use has grown rapidly in recent years. Overall, do you think e-cigarettes have made a positive or negative contribution to public health, or do you think it’s not made any difference?

   1. Why is that?

2. Some people believe that e-cigarettes should be used to help people stop smoking, for example by being recommended by health services, while others do not. What do you think? Why?

3. To what extent do you think e-cigarettes should be regulated (a) in line with tobacco cigarettes and (b) as a distinct product? Why? What should regulation on e-cigarettes aim to do? (Prompt on: restricting availability of devices and/or liquids; providing health information; stopping youth uptake. )

4. E-cigarette regulation varies a lot internationally. Do you think the balance of e-cigarette regulation overall in Wales/Scotland/England is about right? Too liberal? Too restrictive? Why?

   1. What impacts do you think e-cigarettes have had for young people? Or what kind of effects might they have in the future?

   2. Some people say that e-cigarettes are likely to lead to nicotine addiction in young people. What are your views on that?

   3. Some people say that e-cigarette use mimics smoking behaviour and so will lead people to see smoking as ‘normal’ again. What are your views on that?

Section 3a: Tobacco Products Directive theory

I’d like to talk more specifically now about the TPD legislation.

1. Are you familiar with the Tobacco Products Directive? Where do/have you information about this from? What type of information/support have you received?

2. What do you think is good or bad about the changes introduced by TPD? (Prompt on why for each point made. )

3. How do you think these fit with the wider tobacco control agendas that we discussed earlier?

4. Who do you think the changes introduced by the TPD are aimed at and why? (Prompt on consumers, producers, retailers. )

5. How will we know if TPD has been effective? What would change? (Prompt here on both youth and adult behaviour.)

6. Do you think there might be any unintended harms from TPD? What?

Section 3b: now I’d like to talk more about Tobacco Products Directive implementation and impacts on your business

1. TPD was introduced in May 2016. What do you think has changed? (Prompt on users, retailers, norms. )

   1. What do you think of the warnings displayed on e-cigarette packaging as a result of TPD? (Use visuals if needed. )

   2. Do you think these are expressed the right way? Why?

   3. Do you think these warnings might change the way people see e-cigarettes? In what ways?

   4. Have any of your customers commented on/discussed the warnings with you?

   5. How has TPD been communicated to the public? Has this been effective?

   6. Were you aware of any local campaigns designed to raise awareness of the new regulations?

   7. Has there been any local monitoring and enforcement activity? Is that ongoing?

2. What impact (if any) has TPD had on your business? Why? (Any changes in local competition/prevalence of retailers?)

3. Have you made any changes to the way you market your products? In store/online?

4. What impact (if any) has TPD had on your customers purchasing decisions/willingness to try e-cigs? Why?