BMA calls for strong regulation of e-cigarettes

BMA calls for strong regulation of e-cigarettes March 2012 (updated November 2014) A briefing from the BMA s Board of Science and Occupational Medicine Committee Summary E-cigarettes are increasingly being used by current and ex-smokers to help cut down and quit smoking, to the extent that they are the most popular single type of product used for this purpose. A small proportion of current smokers use e-cigarettes in order to comply with smokefree regulations. There is some evidence in other countries that e-cigarettes may be acting as a gateway to smoking. While data show regular use among non-smoking adults and children in the UK is rare, this needs to be monitored closely, particularly as the availability and promotion of e- cigarettes increases. While e-cigarettes have the potential to support tobacco harm reduction, any benefits or disadvantages to public health are not yet well established. This reflects the lack of conclusive evidence of effectiveness as a smoking cessation aid, concerns regarding the variability of the components of e-cigarette vapour, and the absence of a significant health benefit associated with dual use of e-cigarettes and tobacco cigarettes. The increasing involvement of the tobacco industry in the e-cigarette market has the potential to undermine the progress made on tobacco control in the UK. Doctors have expressed significant concern about the promotion of e-cigarettes in ways that are likely to appeal to children, young people and non-smokers. Other concerns relate to their accessibility on the high-street and online, as well as product safety and quality. To ensure the development and use of e-cigarettes contributes to public health objectives, there is a need for a strong regulatory framework. Regulating e-cigarettes as a licensed medicinal product best reflects their use for harm reduction, ensures their effectiveness, quality, and safety, and provides the necessary controls on their promotion and sale. Doctors believe that e-cigarette use should be prohibited in public places where smoking is prohibited. This is to protect others from being exposed to their vapours, and to ensure their use does not undermine smokefree restrictions or reinforce the normalcy of smoking behaviour. Health professionals should advise their patients to use NHS stop smoking services or a regulated and licensed product to help quit smoking. Where a patient is unable or unwilling to use these services, or to use an approved and tested nicotine replacement therapy, health professionals should help patients understand that e-cigarettes are currently unregulated and therefore their safety and efficacy cannot be assured. If asked, professionals should inform that they are likely to be a lower risk option than continuing to smoke. 1

1. Introduction Electronic cigarettes (e-cigarettes), or electronic nicotine delivery systems (ENDS), have become increasingly popular since the mid-2000s, with rapidly expanding marketing and sales. 1,2,3,4 Increasing numbers of smokers are using these unlicensed nicotine-containing products (NCPs), with some finding them helpful in cutting down or quitting cigarette use. 5,6 It is widely recognised that the health risks associated with e-cigarette use are likely to be significantly lower than the well-established risks associated with smoking tobacco. The BMA therefore recognises their potential for supporting tobacco harm reduction. There is, however, a lack of robust research and evidence in this area, and any public health benefit is not yet well established. This highlights the need for a strong regulatory framework for e-cigarettes to ensure that: all products on the market are effective in helping smokers cut down, with the aim being to quit their marketing and promotion does not appeal to children / young people and non-smokers, or make any claims of effectiveness as a smoking cessation aid unless approved for that purpose by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) their use does not undermine smoking cessation and prevention, or reinforce the normalcy of tobacco smoking behaviours. This briefing examines these issues in more detail by highlighting the emerging evidence on the use of e-cigarettes, and considering the case for a strong regulatory framework. What is an e-cigarette? E-cigarettes are battery-powered products designed to replicate smoking behaviour without the use of combustible tobacco some look like conventional cigarettes, while others appear more like an electronic device (see Appendix 1). 7,8 They consist of a cartridge containing liquid nicotine, an atomiser (heating element), a rechargeable battery, and electronics. 8,9 They turn nicotine, flavour and other chemicals into a vapour that is inhaled by the user. 7,8 The exhaled vapour is visible, and some products have a light emitting diode (LED) at the tip that lights up when the user inhales. 10 2. Emerging evidence on the use of e-cigarettes 2.1 Who uses e-cigarettes? A 2014 survey commissioned by Action on Smoking and Health (ASH) found that awareness of e- cigarettes among the British public is very high: approximately 95 per cent of smokers, and 90 per cent of non-smokers, had heard of e-cigarettes. 5 Another British study similarly found that 93 per cent of current and ex-smokers were aware of e-cigarettes. 11 2

Emerging evidence suggests that e-cigarettes are predominantly used together with conventional tobacco cigarettes (dual use) by current smokers, primarily for the purposes of cutting down or quitting smoking. 12 There are approximately 10 million adults in Britain who smoke cigarettes. 13 The 2014 ASH survey estimated that 2.1 million adults in Britain are current users of e-cigarettes, 5,10 and that the majority of e-cigarette users in Britain are current smokers between 60 and 80 per cent. 5,14 Among adults in England, approximately 17 per cent of current smokers, 2-4.7 per cent of exsmokers, and less than one per cent of non-smokers where found to have used these products. 5,14,15 More than half of all smokers (51%) had ever tried an e-cigarette in 2014, compared to 8.2 per cent in 2010. 5 Smokers in the UK have been found to be more likely to have ever used e-cigarettes, or used them as a smoking cessation aid, than the EU average. 16 Surveys have also found that, compared to users of licensed nicotine products, e-cigarette users are: more likely to have made a quit attempt in the past year 11 more likely to intend to quit smoking in the next six months 12 more likely to be younger and have higher socioeconomic status 10,11 more nicotine dependent than smokers who do not use e-cigarettes 6,12 more likely to be smoking 20 or more cigarettes a day. 11,17 2.2 Why do people use e-cigarettes? Data from the 2011 International Tobacco Control Four Country Survey (Australia, Canada, UK, US) found that study participants (current and ex-smokers) reported using e-cigarettes because they believed they were less harmful than cigarettes (79.8%), to reduce smoking (75.8%), and to help quit smoking (85.1%). 17 Other studies have cited smoking cessation, preventing relapse, and perceived health benefits associated with smoking abstinence (such as less coughing and improved physical fitness), as key reasons for using e-cigarettes. 10,18 In Britain, the most common reasons for use of e-cigarettes by current smokers have been found to be to reduce consumption of tobacco but not stop completely (48%), or to save money (37%) (see Section 3.3 for information on cost differentials). 15 For ex-smokers, the most common reason for use was to help quit (71%), while for others it was to prevent relapse to smoking (48%). 15 Another British survey found that the key motivations for using e-cigarettes were for health, cutting down and quitting. 11 The 2014 ASH survey found that a proportion of current smokers (15%) stated that they primarily use e-cigarettes for situations where smoking is not permitted, in order to circumvent smokefree regulations. 5 A 2010 European study found that 26 per cent of e-cigarette users used the product for this purpose. 10 3

2.3 How does e-cigarette use compare to use of other nicotine-containing products? Despite not being licensed as a nicotine replacement therapy (NRT), a e-cigarettes are now the most popular single type of NCP among current smokers and ex-smokers, ahead of licensed NRT, in particular prescription NRT. 14 The increasing use of e-cigarettes has led to an increase in total NCP use among smokers and recent ex-smokers. 14 2.4 Are e-cigarettes acting as a gateway to smoking? Concern has been expressed in relation to e-cigarettes being entry portals to nicotine use and addiction. Evidence suggests that this is very rare among adults. As noted in Section 2.1, less than one per cent of adult non-smokers in England have tried e-cigarettes, and only 0.1 per cent use them regularly. 5,19 For children and young people, while awareness of e-cigarettes among children in the UK is high (66% among 11-18 year olds, and 83% among 16-18 year olds), only two per cent of 11-18 year olds have been found to use e-cigarettes monthly or weekly, and seven per cent have tried them at least once. 5 Of these users, the vast majority are those who have already tried smoking among those who had never smoked a cigarette, 99 per cent report never having tried e-cigarettes, with one per cent reporting to having tried them once or twice. 5 Although levels of use are low in the UK, experiences in other countries (such as Italy, Korea and the US where e-cigarette use has rapidly increased over a similar time period as the UK) suggest the need to closely monitor use among children and young people. 20,21,22 For example, research based on the US national youth tobacco survey indicates that ever e-cigarette use doubled among high school students between 2011 (3.3%) and 2012 (6.8%). 23,24 Twenty per cent of US middle school students, and seven per cent of high school students, who had ever used e-cigarettes were found to have never tried a tobacco cigarette, amounting to an estimated 160,000 young people. 23 Various evaluations of the US national youth tobacco survey have suggested that adolescents using e- cigarettes are more likely to intend to use conventional cigarettes, more likely to be current or heavy smokers, and less likely to quit or attempt to quit smoking. 23,24,25 In addition to monitoring the uptake of e-cigarette use among children and young people, other factors to consider are the way these products are marketed and sold, so that they are not readily promoted or accessible to these age groups (see Sections 3.2, 3.3 and 4). a These are nicotine products (such as gums, patches, and inhalers) that have been granted a medicines licence by the MHRA. These products have been clinically demonstrated to be more effective in achieving smoking cessation than no support. A NRT can be accessed via prescription or over the counter. 4

3. The case for regulation The emergence and proliferation of e-cigarettes, as well as their popularity over licensed NRT, highlights the need to ensure their development and use supports public health objectives. This centres on consideration of their potential to reduce tobacco-related harm, how they are marketed and sold, and issues related to product quality and safety. 3.1 E-cigarettes and harm reduction While the benefits or disadvantages of e-cigarettes to public health are not yet clear, the BMA recognises their potential to contribute to tobacco harm reduction b provided they are proven to be safe and effective in helping users to cut down and quit smoking. It is therefore necessary to establish their efficacy for smoking cessation, as well as the health risks associated with their use compared to conventional tobacco cigarettes or to quitting altogether. There is also a need to establish whether the use of e-cigarettes may be a public health risk by: prolonging smoking and delaying some smokers from successfully quitting who might otherwise have done so; encouraging continued nicotine use in people who might otherwise have quit; undermining smokefree legislation and tobacco control policies, or reinforcing the normalcy of smoking behaviour; promoting tobacco smoking. 1,26,27,28,29,30,31 3.1.1 Effectiveness as a smoking cessation aid There is inconclusive evidence to demonstrate whether e-cigarettes are effective in helping smokers cut down and quit the use of tobacco cigarettes, or in preventing relapse (see Appendix 2). Research suggests that e-cigarettes are primarily effective in helping smokers cut down their consumption of tobacco cigarettes, but there is inconsistent evidence about whether they are more effective than licensed NRT in achieving smoking cessation. 12,26,32,33 Peer-reviewed studies have found that e-cigarettes may be more effective in decreasing cigarette consumption over a six to 12 month period in smokers, compared to NRT. 6,17,34,35,36 Some research suggests that e-cigarettes have comparable effectiveness to licensed NRT in helping smokers to successfully quit. 17,26,35,36 Other studies have found that e-cigarette use is not associated with successful quitting, 17,37 or that e-cigarette users were less likely to quit than non-users. 18,21,26 Dual use b The BMA supports the development of a tobacco-free harm reduction approach as a part of a structured programme leading to permanent smoking cessation, focusing on the use of licensed and regulated pure nicotine products. The National Institute for Health and Clinical Excellence (NICE) produced guidance on Tobacco: harm reduction approaches for smoking, and recommended that only licensed nicotine replacement therapy products should be recommended to patients by health professionals as an effective harm reduction measure. It noted that health professionals should make patients aware that the effectiveness of e-cigarettes in smoking cessation and cutting down has not been established, but they are likely to be less harmful than continuing to smoke cigarettes. 29 5

of e-cigarettes and tobacco cigarettes may perpetuate nicotine addiction, decreasing the odds of successfully quitting. 12,26 A meta-analysis of peer-reviewed population studies investigating the effectiveness of e-cigarettes as smoking cessation aids found that e-cigarette use among smokers was associated with lower odds of quitting smoking. 12 It is worth noting that current evidence indicates that behavioural support and prescription medication provided by NHS stop smoking services still provides the greatest chance of successfully quitting smoking, with users of these services three times more likely to quit than those who use neither pharmacotherapy nor behavioural support. 6,38 This raises the issue of the need to ensure that the wider availability of e-cigarettes does not impact upon the provision or use of effective smoking cessation services. 39 There is evidence that the use of NHS stop smoking services has recently declined, with the number of people setting a quit date through NHS stop smoking services in 2013-14 reducing by 19 per cent compared to 2012-13. 40 This decline has been attributed to the use of e- cigarettes as smoking cessation aids. 41 It is clear that further research is required to understand the effectiveness of e-cigarettes as smoking cessation aids, relative to other approaches. This is especially important if they are used in place of currently licensed NRT or stop smoking services. 3.1.2 Health risks of e-cigarette use Substituting tobacco with e-cigarettes is likely to substantially reduce exposure to tobacco-specific toxins. 42 The potential health risks associated with exclusive e-cigarette use are therefore likely to be much lower than the risks of smoking tobacco cigarettes. 43 There is a need, however, to consider the risks associated with inhaling the components of e-cigarette vapours. These components include nicotine, as well as a range of other chemicals. 43,44 While the BMA supports the use of licensed NRT as a smoking cessation aid, it should be recognised that the consumption of nicotine is not entirely risk-free. Nicotine is a highly addictive substance and users can quickly become physically dependent. 45,46 Nicotine withdrawal is associated with craving, anxiety and stress. 47 Data suggest that nicotine may be an important mechanism by which tobacco promotes tumour development, progression, and resistance to cancer treatment. 48 The physiological effects of nicotine include increased blood pressure, increased heart rate, transient tachycardia and vasoconstriction. 47,49,50 Symptoms of nicotine toxic overdose include tremors, nausea, vomiting, convulsions, neuromuscular blockade, diarrhoea and gastrointestinal irritation. 49 Chronic exposure to nicotine is associated with an increased risk of stroke, hypertension, reproductive disorders, peptic ulcer disease and high total cholesterol. 49 Despite this there are some studies that indicate no adverse health effects of prolonged NRT use in individuals who have quit smoking. 50,51,52 6

In addition to nicotine, e-cigarettes contain propylene glycol and glycerine, which can cause eye and respiratory irritation. 10,12,16,27, 44,53 A number of studies have recorded toxic and carcinogenic components of e-cigarette liquid and aerosol vapour: diethylene glycol (a toxic chemical) in one cartridge at approximately one per cent 53,70 tobacco-specific nitrosamines (which are human carcinogens) in half of the samples, at levels comparable to those measured in licensed NRT 27,53 tobacco-specific impurities suspected of being harmful to humans (anabasine, myosmine, and ß-nicotyrine) in a majority of the samples 53 heavy metals such as tin, nickel, copper, lead, chromium (originating from the heating elements or batteries in e-cigarettes). 10,12,54 Other studies have reported acetaldehyde (a throat irritant) and other organic compounds, such as formaldehyde and acetaldehyde, and derivatives of benzene and benzodiazepine. 27,42,54 Chemicals used to flavour some e-cigarette liquid may have cytotoxic effects. 12,55 There are data to indicate that lung function is impaired immediately following e-cigarette use. 56 3.1.3 Health risks of dual use Consideration of the health risks of e-cigarette use needs to take account of the risks of using e- cigarettes concurrently with tobacco cigarettes (dual use). This reflects the fact that, even if overall tobacco consumption is reduced, dual use is likely to be much less beneficial than quitting smoking completely, or switching exclusively to e-cigarette use. 12,26 The basis for this is that, compared to the intensity of smoking, the duration of smoking has been found to have a greater impact on the health risks associated with smoking including lung, pancreatic, oesophageal and bladder cancers, cardiovascular disease and risk of premature death. 12,26,57 As noted previously, evidence suggests that e-cigarettes are primarily effective in helping smokers reduce the intensity of smoking (by cutting down), rather than the duration of smoking (by quitting). 12,26,33 The WHO Tobacco Free Initiative estimates that e-cigarettes are likely to have little or no effect on mortality risk, no effect on cardiovascular disease risk, and a small reduction in cancer risk in e-cigarette users who continue to smoke tobacco cigarettes. 26 3.1.4 Additional concerns With the development of a range of tobacco control policies, rates of tobacco use in the UK have declined. 58,59 There is concern that e-cigarette use may undermine this progress. 60 All of the major tobacco companies have invested in e-cigarettes and have launched or acquired e-cigarette brands. 26,60,61 In 2010, the US Surgeon General warned that it was common practice for the tobacco industry to use new tobacco products to undermine tobacco control policies, smoking cessation and smoking prevention in young people. 62 A key motivation for tobacco industry investment in the e- cigarette / harm reduction market is to increase their influence by opening up dialogue with governments, policy makers and the public health community 12,26,61 Other factors include: reducing 7

competition between the e-cigarette and tobacco cigarette markets; promoting company corporate social responsibility profiles without committing to decreasing tobacco manufacturing and sales; promoting dual use of e-cigarettes and tobacco cigarettes; greater marketing freedom; and providing new smokers with a low cost, low risk entry product. 12,26,60,61 3.2 Marketing Concerns have been expressed by BMA members over the e-cigarette marketing methods used across a range of advertising media and locations that are likely to appeal to children, young people and non-smokers. These include point-of-sale displays; advertising via television, radio, in print media and online; on billboards near schools; at university freshers fairs; and the marketing of flavoured e- cigarettes. 63 The BMA is also concerned that e-cigarette marketing may have an adverse impact, reinforcing conventional cigarette smoking habits, as well as indirectly promoting tobacco smoking, and increasing the likelihood of young people starting to smoke. 1,29,64 The e-cigarette market in the UK increased by 340% in 2013, and is estimated to be worth 193 million. 65 There are now more than 450 brands of e-cigarette, and 7,700 unique flavours. 66 E-cigarette promotion ranges from being advertised as a healthier alternative to smoking traditional tobacco products, to evocative advertising with phrases such as love your lungs, vape with style, smoking is so last season and add flavour to your lifestyle. The advertising and promotion also frequently makes positive associations with recreational activities, sports and youth culture, and can incorporate celebrity endorsements. 1,26,64,67 Analysis of e-cigarette retail websites found that 95 per cent of the websites made direct or indirect claims about health benefits of e-cigarettes, including smoking cessation (64%) and lack of secondhand smoke (76%). 12 Eighty eight per cent stated that e-cigarettes could be used anywhere, or specifically to circumvent smokefree legislation (71%). 12 A US study found that exposure to e- cigarette advertising on television in youth (12-17 years) increased 256 per cent between 2011 and 2013, and by 321 per cent in young adults (18-24 years). 68 Another study found that e-cigarettes are heavily marketed via social media platforms such as Twitter, where 90 per cent of tweets on e- cigarettes were classified as commercial, and included links to websites selling or promoting products. 69 Ten per cent of tweets specifically mentioned smoking cessation. 69 Analysis of the growing market for e-cigarettes suggests that marketing targets two distinct audiences: current smokers who want to quit, and children / young people and non-smokers. 64,70 For children / young people and non-smokers, e-cigarettes are positioned as socially attractive, appealing and popular, using flavouring, promotional discounts, sports sponsorship and celebrity endorsement to attract new customers. 12,64 A review by the US Senate in 2014 concluded that e-cigarette companies are employing the same marketing tactics that the tobacco industry first pioneered to attract young customers to their product: sponsored sports and music events; free samples; television advertising during youth programming, sports events or daytime television; celebrity spokespeople 8

and endorsement; social media presence; and product flavouring. 67 The review noted the rapid increase in marketing spending by e-cigarette companies in the US, and the lack of regulation of sales to children under 18 years of age. 67 For smokers, e-cigarettes are marketed as healthier, safer, cheaper and a way for smokers to cut down or stop smoking. 12,64 In the UK media, e-cigarettes are frequently portrayed as a healthier and cheaper alternative to tobacco cigarettes, and encouraged for use to circumvent smokefree laws. 71 The UK Advertising Standards Authority (ASA) has previously ruled that certain e-cigarette advertisements were considered misleading and made unsubstantiated claims relating to health. 72 All advertisements in the UK are regulated by the ASA. In October 2014, the Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice (BCAP) jointly published new advertising rules for e-cigarettes. These new product specific rules came into force on 10 November 2014, and apply across media. Both Committees will monitor the effect of the rules and conduct a formal review after 12 months. The BMA has already expressed concern that these rules are not adequate for preventing the promotion of e-cigarettes to young people or non-smokers. 73 It should be noted that the European Tobacco Products Directive (2014/40/EU) also contains new legislative provisions around the promotion of e-cigarettes, but these will not come into effect until 2016 (see Appendix 3). 3.3 Sales There are no regulations c on the sale of e-cigarettes as age restricted products, including their sale to children. E-cigarette manufacturers do not recommend sale to under-18s, and some retailers impose their own age restrictions. A 2014 investigative report from the Trading Standards Institute found that a significant proportion (40%) of UK retailers disregarded the recommended age restriction for sale of e-cigarettes. 74 In terms of accessibility, e-cigarettes can be bought from a variety of high street outlets, ranging from newsagents, superstores, and pharmacies to pubs and specialist shops. E-cigarettes and liquid nicotine ( juice ) can also be purchased online, even in wholesale quantities. 75 It is worth noting that the cost of using e-cigarettes is comparatively lower than using tobacco cigarettes while the initial cost of the e-cigarette starter kits can be four or five times higher than a pack of 20 tobacco cigarettes, the ongoing costs (of cartridge refills and other components) is lower than that of purchasing tobacco cigarettes. This lower cost is commonly cited as a benefit to using e- cigarettes compared to smoking. 15 c In England and Wales, the Children and Families Act provides the powers to prohibit the sale of nicotine products to people under 18. Similar provisions are being considered in Scotland and Northern Ireland. 9

3.4 Safety and product quality In the UK, e-cigarettes are subject to regulation under the General Product Safety Regulations 2005, the Chemicals (Hazard Information & Packaging for Supply) Regulations 2009, and by trading standards. 76 There is no requirement for manufacturers of e-cigarettes to list the nicotine content of their products, include childproof safety features, or take measures to protect against accidental overdose. 31 Concerns have been raised about the quality and safety of e-cigarettes and liquid nicotine, including from e-cigarette users. 10,34,35,36 Of particular concern is that e-cigarettes are often imported from countries which have less stringent product control regulations. 39 As noted in Section 3.1.2, nicotine can have toxic effects. 49 There is evidence that nicotine delivery by e-cigarette products is highly variable, as it is influenced by the concentration of nicotine in the e- cigarette liquid, the product design and vapourising technology of e-cigarette brands, and user puffing behaviour. 9,12,42,77 Laboratory analysis of e-cigarettes indicates that labelling of nicotine levels in e- cigarette liquid may be inconsistent and misleading. 53 In experienced users of e-cigarettes, plasma nicotine levels after e-cigarette use can be comparable to smoking a conventional tobacco cigarette. 12,78,79 Other research indicates that plasma nicotine levels are approximately one third to one quarter of that observed with tobacco cigarettes after five minutes of inhaling. 80 The Trading Standards Institute and others have stated that safety concerns have come to light around some brands of e-cigarettes, including electrical safety, the need for proper labelling, and the provision of child resistant packaging. 76,81 The Chief Fire Officers Association has also highlighted the fire risks associated with e-cigarettes, including the risks of using e-cigarettes in the presence of home oxygen cylinders. 82 One particular area of concern is accidental exposure to liquid nicotine, which can be ingested or absorbed via skin contact. Evidence suggests this is becoming an increasing problem, with a rise in the number of reports related to nicotine exposure from e-cigarettes by health professionals to the National Poisons Information Service. 83 Between 2006 and 2011, 36 calls were reported, increasing to 29 calls in 2012, and 139 in 2013. 83 These related to children aged four and under in 36.5 per cent of cases, children aged 5-18 in 7.5 per cent of cases, and adults over the age of 18 in 56 per cent of cases. 83 Reported symptoms included nausea, vomiting, abdominal pain, and dizziness. 83 Admissions to accident and emergency (A&E) units after exposure to liquid nicotine have also been reported. 75 A similar trend has been reported by the US Centres for Disease Control and Prevention. 84 10

4. The need for a strong regulatory framework The concerns highlighted in the preceding sections highlight the need for strong regulation in order to: establish that e-cigarettes are safe and effective in helping people cut down or with the aim being to quit smoking; guarantee standards of product safety and quality; ensure that e-cigarette use does not undermine smoking cessation attempts. There is also significant concern about the marketing of e-cigarettes, including: the widespread promotion of e-cigarette in ways that are likely to appeal to non-smokers and children / young people; the misleading or unsubstantiated claims relating to health that are being made in some advertising; and the absence of age restrictions on the sale of e-cigarettes. Appendix 3 provides an overview of the existing regulatory framework. Medical licensing and marketing restrictions Regulating e-cigarettes as a licensed medicinal product would best reflect their use for harm reduction, bring them in line with existing NRT products, and ensure their effectiveness, quality, and safety. This form of regulation would also provide the necessary controls on their marketing and promotion. Rules on the marketing and promotion of e-cigarettes should be in line with the following principles: the marketing of e-cigarettes should not appeal to children / young people and non-smokers marketing of e-cigarettes should not make or imply any claims of effectiveness as a smoking cessation aid, unless the product has obtained a medicines license from the MHRA marketing of e-cigarettes should not include any misleading information that implies a health benefit of e-cigarettes marketing of e-cigarettes should not promote the re-normalisation of conventional tobacco cigarette smoking. Restrictions on the age of sale Prohibiting the sale of e-cigarettes to under-18s would help reduce the likelihood of children and young people accessing these products and becoming addicted to nicotine, as well as limiting the potential for e-cigarettes to be a gateway to future tobacco use. It would also complement existing age restrictions for the sale of tobacco products. 5. E-cigarettes in workplaces and enclosed public places Restrictions on where e-cigarettes can be used are limited and variable in the UK they are prohibited in some but not all workplaces, as well as in places such as restaurants, pubs, public 11

transport and airlines. While there are differing views among the public health community on this aspect, the BMA believes that stronger controls are needed on where e-cigarettes can be used in order to: protect others from being exposed to e-cigarette vapours. Studies have indicated that bystanders can be exposed to vapour emitted from e-cigarette use, 26,85,86,87 and the WHO has warned of the potential adverse health effects of exposure to toxicants and particles contained within e-cigarette vapour 88 ensure their use does not undermine existing restrictions on smokefree public places and workplaces by leading people to believe it is acceptable to smoke. Of particular concern to BMA members is their use by patients, visitors and staff in hospitals and other healthcare settings, and their use may become a source of conflict between staff and patients. Similar concerns exist in other settings, such as the use of e-cigarettes on airplanes ensure their use does not undermine the success of conventional tobacco control measures by reinforcing the normalcy of smoking behaviour in a way that other nicotine containing products do not. 60 This specifically relates to the way some of these devices commonly resemble tobacco cigarettes in terms of appearance, nomenclature and the way they are used. In light of these concerns, the BMA believes that e-cigarette use should be prohibited in public places where smoking is prohibited. This approach is supported by the WHO, the American Heart Association and the Forum of International Respiratory Societies. 50,88,89 As an interim measure, we also encourage employers to incorporate prohibiting the use of e-cigarettes in their workplaces as part of organisation-wide smokefree workplace policies, and supporting staff to use smoking cessation services. 6. Advice for health professionals In light of the lack of robust scientific evidence about the efficacy and safety of e-cigarettes, coupled with the absence of a strong regulatory framework in the UK, health professionals should encourage their patients to use NHS stop smoking services or a regulated and licensed NRT to help quit smoking. This is in agreement with NICE guidelines on the use of nicotine replacement therapy for harm reduction. 29 Current evidence still supports the use of NHS stop smoking services, as giving individuals the greatest chance of quitting. 6,38 Where a patient is unable or unwilling to use these services, or to use an approved and tested nicotine replacement therapy, health professionals may advise patients that while e-cigarettes are currently unregulated and therefore their safety and efficacy cannot be assured, they are likely to be a lower risk option than continuing to smoke. 12

Appendix 1 Examples of types of e-cigarettes 13

Appendix 2 Summary of published research investigating the effectiveness of e-cigarettes as a smoking cessation aid Author, date and country Adkison et al, 2013 UK, USA, Canada, Australia Type of study Longitudinal survey (International Tobacco Control study) Study participants (n) Current and former smokers (n=5939) Key findings: smoking cessation E-cigarette users not more likely to have quit smoking than non-users E-cigarette users reduced daily cigarette consumption more than non-users Brown et al, 2014 England Representative cross-sectional survey of English adults (Smoking Toolkit study) Adult smokers who had smoked within the previous 12 months and made at least one quit attempt (n=5863) Adjusted odds of non-smoking in e- cigarette users: 1.63 times higher than users of over the counter NRT 1.61 times higher than those using no aid Bullen et al, 2013 New Zealand Caponetto et al, 2013 Italy Randomised controlled clinical trial Smokers assigned to nicotine e- cigarette, nonnicotine e- cigarette or NRT patch 6 month follow up Randomised controlled clinical trial Smokers assigned to high-, low-, or nonnicotine e- cigarettes 12 month follow up Adult smokers motivated to quit (n=657) Smokers 18 to 70 years old who were not intending to quit (n=300) No significant difference in 6 month quit rates among treatment groups 57% of nicotine e-cigarette users decreased tobacco cigarette consumption by more than half No significant difference in 6 or 12 month quit rates among e-cigarette treatment groups A quarter of successful quitters continued to use e-cigarettes at 12 months Choi et al, 2014 USA Longitudinal survey 12 month follow up Cohort of young adults (smokers and nonsmokers) Smokers using e-cigarettes were less likely to have quit smoking after 12 months than smokers who did not use e-cigarettes Etter and Bullen, 2014 Longitudinal survey 12 month follow up Smokers motivated to quit, recruited online (n=367) No significant difference in daily cigarette consumption between e- cigarette users and non-users. 46% of dual use participants had quit smoking tobacco cigarettes at 12 month follow up No significant difference in daily tobacco cigarette consumption in 14

dual use participants who had not quit smoking at 12 month follow up 6 per cent of ex-smokers using e- cigarettes had relapsed to smoking tobacco cigarettes at 12 month follow up. Grana et al 2014 USA (JAMA) Polosa et al, 2010 Italy Longitudinal survey 12 month follow up Clinical trial Smokers offered e-cigarettes 6 month follow up National sample of smokers (n=949) Smokers 18 to 60 years old who were not intending to quit (n=40) E-cigarette use did not predict successful quitting at 12 month follow up 48.5% of smokers were using e- cigarettes and tobacco cigarettes (dual use) at follow up 33% of smokers had stopped using tobacco cigarettes at follow up Cigarette consumption decreased by 50% in dual use users Polosa et al, 2013 Italy Clinical trial Smokers offered e-cigarettes 18 and 24 month follow up Smokers 18 to 60 years old who were not intending to quit (n=23) 78% of smokers were using e- cigarettes and tobacco cigarettes (dual use) at follow up 48% of dual use participants decreased tobacco cigarette consumption by more than half 22% of e-cigarette users had quit smoking tobacco cigarettes at 24 months Popova et al, 2013 USA Vickerman et al, 2013 USA Cross-sectional survey Longitudinal 7 month follow up National cross sectional sample of current and recent exsmokers (n=1836) Stop smoking quit-line callers (n=2758) Smokers who had ever used e- cigarettes were less likely to have quit smoking than smokers who had not used e-cigarettes, including among smokers intending to quit E-cigarette users were less likely to have quit at 7 month follow up than non-users 15

Appendix 3 Overview of existing regulatory framework for e-cigarettes in the UK E-cigarettes are currently regulated as general consumer products. In light of revisions to the European Tobacco Products Directive (TPD), from May 2016, e-cigarettes containing up to 20mg/ml of nicotine will be regulated by the provisions of the TPD. Where products contain above 20mg/ml of nicotine, or if manufacturers and importers decide to opt into medicines regulation, their sale will require licensing by the MHRA. The following table provides an overview of the characteristics of regulation under the TPD and MHRA. TPD provisions for e-cigarette regulation Products not available on prescription MHRA provisions for regulating products containing nicotine (including e-cigarettes) Products available on prescription 20 per cent VAT 5 per cent VAT Cross border advertising banned by 2016, with Member States to decide on domestic advertising Products widely available Advertising allowed in accordance with existing rules for over-the-counter medications Products available on general sale Health claims prohibited Health claims permitted Upper limits for nicotine content will be set and likely to be in force by 2017 Health warnings about nicotine required on front and back of packs (30%) Member States retain powers on flavouring No upper limits on nicotine content No health warnings on packaging Flavours require a marketing authorisation In England and Wales, the Children and Families Act provides the powers to prohibit the sale of nicotine products to people under 18. Similar provisions are being considered in Scotland and Northern Ireland Sale prohibited to under 12 years of age, but can be varied by product Adapted from: Department of Health position paper on electronic cigarettes Department of Health / JM / ECIGS100614. 16

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