Link to Public Health Wales commitment and priorities for action: (please tick which commitment(s) is/are relevant) x

Transcription

1 Electronic Nicotine Delivery System (ENDS) Position Statement Author: Julie Bishop; Ashley Gould Date: 11 January 2017 Version: 1.0 Sponsoring Executive Director: Dr Chrissie Pickin Date of Board / Committee meeting: 26 January 2017 Committee/Groups that have received or considered this paper: Public Health Wales Executive Team Public Health Wales Board (Development Session) The Board / Committee are asked to: (please select one only) Approve the recommendation(s) proposed in the paper Discuss and scrutinise the paper and provide feedback and comments Receive the paper for information only X Link to Public Health Wales commitment and priorities for action: (please tick which commitment(s) is/are relevant) x Priorities for action include relevant priority for action(s) Date: 11 January 2017 Version: 1.0 Page: 1 of 7

2 1 Introduction This paper outlines a proposed revised position statement on Electronic Nicotine Delivery Systems (ENDS) and supporting Background Paper. The revised position statement takes account of changes in legislation and increasing research evidence in relation to the population health impact of ENDS and proposes a more complete position statement more appropriately tailored to different population groups. The proposed changes also incorporate the position adopted by Public Health Wales in responding to the Public Health Bill. 2 Background ENDS or E-cigarettes include a diverse group of devices that allow users to inhale an aerosol, which typically contains nicotine, flavourings, and other additives. E-cigarettes vary widely in design and appearance, but generally operate in a similar manner and are composed of similar components. They have evolved substantially in design since their emergence onto the market in Public Health Wales adopted its first Position Statement in 2013 on ENDS, at that time very little research information was available on which to base a view and a precautionary approach was adopted, drawing where possible on the existing evidence base in relation to Tobacco and other health harming behaviours. This position evolved during the drafting of responses to consultation by Welsh Government on the Public Health Wales Bill. 3 Description Electronic Nicotine Delivery Systems (ENDS) present both potential benefits and potential harms, so a balance of approaches is needed to help maximise the potential benefits to smokers who wish to quit, and those unwilling or unable to quit, and help minimise the risks to nonsmokers in the general population, and to children and young people. This approach also explicitly acknowledges that a compromise position is necessary to find the balance between protecting the health and wellbeing of children and young people and the need to reduce harm from the use of tobacco by existing smokers. Maximising the benefit for both groups is not possible. The revised statement makes specific recommendations relating to: Children and Young People Non-smokers/non-Vapers Date: 11 January 2017 Version: 1.0 Page: 2 of 7

3 Smokers who wish to quit Committed smokers who are unwilling or unable to quit now In revising the Position Statement the team has taken account of the available scientific evidence and the views of national and international public health bodies. The Public Health Wales Evidence Service has also undertaken two specific evidence reviews in areas where gaps were identified within the existing reviews. The Background Paper that accompanies the proposed Position Statement includes details on the population impact, national, international and legal contexts, views of other public health bodies and organisations, and relevant evidence before drawing conclusions on what the summary position should be. Appendix 1 to this paper summarises the changes between the current organisational Position Statement dated December Finally, the proposed revised Position Statement is attached for agreement. 4 Recommendation(s) The Board is asked to consider the attached Background Paper and Position Statement and to consider the proposed approach. Date: 11 January 2017 Version: 1.0 Page: 3 of 7

4 Appendix 1 Elements of Position Statement Scope of products Prevalence Benefits, harms and safety Regulatory controls Precautionary approach Existing Position Statement content December 2013 Most ENDS are shaped to look like their conventional (tobacco) counterparts (e.g. cigarettes, cigars, cigarillos, pipes, hookahs or shishas). They are also sometimes made to look like everyday items such as pens and USB memory sticks, for people who wish to use the product without other people noticing. There has been a rapid increase in the use, availability and promotion of e-cigs. While there is potential for ENDS to reduce the harm from smoking or help smokers to quit, their effectiveness or safety has not been demonstrated. The current position on regulation of ENDS is unclear. Precautionary approach is adopted until further information becomes available. Proposed new Position Statement November 2016 Unchanged scope, but not specified in the Position Statement. Prevalence data from the Welsh Health Survey 2015 is included. Reference to the commercial interests of tobacco transnational companies and their increasing share of the market, and their increasing advertising/promotion of ENDS. Largely unchanged, Position Statement notes potential benefit to smokers, and low grade of evidence of effectiveness as quit aid, but acknowledges reality that smokers are using ENDS in quit attempts. Significant change around safety with full implementation of Tobacco and Related Products Regulations likely to address many previous safety concerns. Clarity on regulation with enactment of Tobacco and Related Products Regulations, May Precautionary approach still advocated in relation to children and adolescents, pregnant women, and in relation to exposure to second hand aerosols from ENDS. Position statement clearer on potential benefits of ENDS use for committed smokers who are unwilling or unable to quit. The evidence suggests that the health risks posed by e-cigarettes are relatively small by comparison [to tobacco] but the long-term effects should be continued to be studied. Date: 11 January 2017 Version: 1.0 Page: 4 of 7

5 Elements of Position Statement Safety around nicotine Existing Position Statement content December 2013 Nicotine is a poison, scientific testing indicates that the products vary widely in the amount of nicotine and other chemicals they deliver and there is no way for consumers to find out what is actually delivered by the product they have purchased. Proposed new Position Statement November 2016 The Tobacco and Related Products Regulations are likely to address these safety concerns, as they require testing, submission of contents prior to sale, clearer labeling on contents, and restrictions on strength of nicotine in e- liquid. Use of ENDS in quit attempts Renormalisation Gateway effect Use of e-cigs may reduce the likelihood of smokers quitting by displacing scientifically proven methods to help people quit. ENDS mimic smoking a cigarette and could play a role in normalising smoking behaviour. Considerable strides have been made in denormalising smoking but there is much more to do. Anything which may reverse the progress made to de-normalise smoking would be a risk to population health. The presentation of e-cigs as a safe way to smoke may provide a route to nicotine addiction for children and young people; this may in turn lead to smoking tobacco. Addressed directly in relation to advice to smokers wishing to quit: If you smoke and would like to stop there are a range of medicines and other help available from NHS Wales. Research shows that if you get help to quit you are four times more likely to stop. If you prefer to go it alone then e-cigarettes may be helpful in your quit attempt. Independent and unbiased advice on different aids to quitting smoking is available from Stop Smoking Wales. ENDS are a consumer product tried by 15% of the population, and used by 6% (Welsh Health Survey 2015). The renormalisation risk is addressed indirectly in the proposed Position Statement through advice directed at different segments of the population, including the use of ENDS in enclosed public spaces should be restricted on a voluntary basis. Strengthened recommendation in proposed statement around perceptions of ENDS by children and young people, including ENDS should feature alongside other health-harming substances e.g. tobacco and alcohol, in all health education, and be presented as inherently not safe. Date: 11 January 2017 Version: 1.0 Page: 5 of 7

6 Elements of Position Statement Public Health Wales Advice - quitting Existing Position Statement content December 2013 Smokers who wish to quit or reduce their smoking, should be advised to access one of the free NHS services which provide scientifically proven support including a range of tested nicotine replacement products (Stop Smoking Wales ). Proposed new Position Statement November 2016 Advice unchanged. Public Health Wales Advice - advertising Public Health Wales Advice indoor spaces The promotion of e-cigs/ends should be strictly limited to smokers only. It should not promote the concept of safe smoking and should only be as a way to cut down and quit. Whether any marketing should be allowed at all requires urgent review. Their use should be prohibited in workplaces, educational and public places to ensure their use does not undermine smoking prevention and cessation by reinforcing and normalising smoking. The Tobacco and Related Products Regulations 2016 restrict ENDS advertising on television, radio, and in newspapers and magazines. Advertising in some media is permitted. Position Statement includes There should be restrictions on the advertising of ENDS in all media that would be regularly viewed by children and young people. Proposed position statement advocates Until a more definitive risk assessment can be completed, voluntary restrictions on the use of ENDS in enclosed public spaces should continue. This position relates more to risks around second hand aerosol than renormalisation. Public Health Wales Advice indoor spaces ENDS should not be available to those under 18. Anything that might increase their appeal to children should be avoided e.g. flavouring; packaging Not included in the proposed Position Statement, but: from October 2015 it became illegal to sell e-cigarettes or e- liquids to someone under 18, and for adults to buy (or try to buy) tobacco products or e-cigarettes for someone under 18. The proposed Position Statement advocates for a systematic enforcement programme of the above legislation. The proposed Position Statement advocates that Confectionary-like flavours of e-liquid should be banned. Date: 11 January 2017 Version: 1.0 Page: 6 of 7

7 Elements of Position Statement Public Health Wales Advice promotion Public Health Wales Advice research Existing Position Statement content December 2013 Promotion must not appeal to non-smokers, in particular children and young people. This could include product appearance and packaging being plain in order not to attract people into using it. There should be no flavoured products. Research is needed to increase our understanding of ENDS in particular the safety; effectiveness; role in normalising smoking behaviour and role as a gateway to nicotine addiction and smoking, particularly in children. Proposed new Position Statement November 2016 The Tobacco and Related Products Regulations require warnings on packages; restricts promotional claims that can be made; restricts ENDS advertising, and requires that all products are child and tamper proof. The proposed Position Statement advocates that Confectionary-like flavours of e-liquid should be banned. and There should be restrictions on the advertising of ENDS in all media that would be regularly viewed by children and young people. Safety concerns should be addressed by the Tobacco and Related Products Regulations. Research into effectiveness of ENDS in supporting quit attempts is ongoing. The proposed Position Statement acknowledges that the majority of smokers attempting to quit do so without specialist support, and ENDS may have a role here. Research into children s ability to differentiate between smoking and ENDS use (vaping) has being commissioned by Public Health Wales. Date: 11 January 2017 Version: 1.0 Page: 7 of 7

8 Position Statement: PRID/S/003 Date of Publication: 26 th January 2017 Date of Review: February 2018 E-CIGARETTES (ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS)) ENDS present both potential benefits and potential harms, so a balance of approaches is needed to help minimise the risks to children and young people and non-smokers in the general population and to maximise the potential benefits to committed smokers who are unwilling or unable to quit as well as those who wish to quit smoking. For children and young people: The use of nicotine by children and young people is unsafe, it can cause addiction and can harm the developing adolescent brain - there are no benefits to children and young people in using ENDS. There is concern that ENDS are seen as safe but this is not the case, while the health risks of ENDS are significantly lower than cigarettes they are not without risk. ENDS should feature alongside other health-harming substances e.g. tobacco and alcohol, in all health education for children and young people, and be presented as harmful to health. A systematic enforcement programme should be developed to minimise the sales of ENDS to those less than 18 years of age, including development of a register of retailers and systematic test-purchasing, prosecution and media activity. Confectionary-like flavours of e-liquid should not be permitted, in order to reduce the appeal of ENDS to children and young people. There should be restrictions on the use of ENDS in settings predominantly used by children e.g. in schools and school grounds and around the entrances to schools. There should be restrictions on the advertising of ENDS in all media that would be regularly viewed by children and young people. For the non-smoking general population: There is some evidence of the potential for ENDS use to have a negative impact on indoor air quality and therefore represent a risk to health. Currently, the available evidence is inconclusive on the level of potential harm and more work is required. Voluntary restrictions on the use of ENDS in many public spaces are already in place. VERSION 0.8 Public Health Wales Position on Electronic Nicotine Delivery Systems Page 1 of 6

9 Until a more definitive risk assessment can be completed, voluntary restrictions on the use of ENDS in enclosed public spaces should continue. For smokers who want to quit: NHS stop smoking services which provide behavioural support and access to licensed pharmacotherapy currently offer the greatest likelihood of stopping smoking. However, the majority of smokers who make a quit attempt do so without specialist support. For these smokers, ENDS may prove helpful in achieving a successful quit from tobacco although they are not currently licensed as a medicine for this purpose. If you smoke and would like to stop there are a range of medicines and other help available from NHS Wales. Research shows that if you get help to quit you are four times more likely to stop. If you prefer to go it alone then e-cigarettes may be helpful in your quit attempt. Independent and unbiased advice on different aids to quitting smoking is available from Stop Smoking Wales. Public Health Wales will include information on ENDS alongside other aids to stopping smoking in all information materials and in Stop Smoking Wales support services. Information on all products will be presented to support smokers in making an informed choice about the best way to quit for them. The use of ENDS by pregnant women is not recommended. Health and care professionals giving smoking cessation advice should be able to describe the relative quit rates of, and likelihood of success from, using different smoking cessation methods, including ENDS; to help smokers make an informed choice about the best route to quitting smoking for them. For committed smokers who are unwilling or unable to quit: For committed smokers who are unwilling or unable to quit there is a high degree of consensus that the benefits of using ENDS significantly outweigh the harms. The harms associated with the alternative, of continuing to use tobacco, are significant and well established. The exception to this advice would be for pregnant women, as the potential risks to the unborn child are unknown. If you are a smoker who is unwilling or unable to stop smoking now, switching completely from smoking tobacco to using e-cigarettes will significantly reduce the risks to your health. This advice does not apply to pregnant women who should consider using licensed nicotine replacement products. Health care workers working with those smokers who are unwilling or unable to quit now should advocate a complete switch to using e-cigarettes, as this will significantly reduce the risks to their patients health. This advice does not apply to pregnant women who should be encouraged to switch to licensed nicotine replacement products. VERSION 0.8 Public Health Wales Position on Electronic Nicotine Delivery Systems Page 2 of 6

10 BACKGROUND Electronic cigarettes, or e-cigarettes, including e-pens, e-pipes, e-hookah, and e- cigars are known collectively as ENDS electronic nicotine delivery systems. ENDS deliver nicotine within an inhalable aerosol by heating a solution that typically contains nicotine, propylene glycol and/or glycerol, plus flavours. This aerosol is commonly referred to as vapour and so the use of an ENDS is described as vaping. Unlike cigarettes, there is no direct combustion involved in ENDS so there is no smoke and no other harmful products of tobacco combustion, such as tar and carbon monoxide. While addiction to nicotine is not desirable, nicotine is not responsible for the vast majority of harm from smoking cigarettes and other tobacco products. Nicotine is an addictive substance and can be toxic when ingested in large doses. It may also contribute to cardiovascular disease, and have long-term consequences for foetal and adolescent brain development. The Welsh Health Survey 2015 noted 6% of adult respondents reported currently using ENDS and 15% having ever-tried them. This compares to 19% reporting they smoke, in the same national survey (Welsh Government, 2015). Public Health Wales and a range of other bodies, has previously identified a number of potential risks and benefits to population health from the rise in use of ENDS. These include: The potential role of widespread use of ENDS in re-normalising smoking, and there remains a gap in the current evidence base in this area and further research is needed. Use of e-cigs may reduce the likelihood of smokers quitting by displacing scientifically proven methods to help people quit. The use of ENDS will act as a gateway to tobacco use. The absence of longitudinal studies in this area means that it is very difficult to answer this question definitively, but evidence suggests that ENDS use is associated with tobacco use, with the relationship being poorly understood. ENDS, while presenting a lower health risk for existing smokers than tobacco use, are not safe. There is an international consensus that for non-smokers use of e-cigarettes represents a potential risk to health. VERSION 0.8 Public Health Wales Position on Electronic Nicotine Delivery Systems Page 3 of 6

11 Percentage 25 Welsh Health Survey 2015, Adults reporting e-cigarette usage, by age All aged Age Banding Currently use e-cigarettes Ever used e-cigarettes Figure 1 Adults reporting e-cigarette use, by age, WHS 2015 The best available current international evidence has been utilised in developing this position statement. The supporting technical background paper provides more information on the evidence considered. EVIDENCE ENDS aerosol contains nicotine, the addictive component of tobacco products. In addition to dependence, nicotine can have adverse effects on the development of the foetus during pregnancy and may contribute to cardiovascular disease. [...] Foetal and adolescent nicotine exposure may have long-term consequences for brain development, potentially leading to learning and anxiety disorders. The evidence is sufficient to warn children and adolescents, pregnant women, and women of reproductive age against ENDS use and nicotine. (WHO, 2016) The World Health Organisation have also identified fruit and confectionary flavours as appealing to children, younger never-smokers and young ENDS beginners and may therefore play a role in motivating experimentation among them. (WHO, 2016) Recent research has indicated the potential risk to non-smokers of passive exposure to second hand aerosols (SHA) from vaping (WHO, 2016). There is relatively little conclusive evidence on the risks relative to second hand smoke or ambient air, but some studies indicate levels of nickel and chromium higher in SHA from ENDS than in second hand smoke and background air. The magnitude of the associated risks to health remain unknown. A Cochrane systematic review published in September 2016 found evidence from two trials that ENDS were more likely to help smokers to quit in the long term, than placebo ENDS. However, the small number of trials, low event rates and wide confidence intervals around the estimates mean that confidence in the results is rated 'low'. (Hartmann-Boyce et al, 2016) VERSION 0.8 Public Health Wales Position on Electronic Nicotine Delivery Systems Page 4 of 6

12 ENDS are capable of providing of the nicotine that smokers are addicted to without the harmful components of tobacco smoke, and so can prevent most of the harm from smoking (RCP, 2016). The number and level of toxicants generated by using ENDS is on average lower or much lower than in cigarette smoke, and ENDS are less toxic than cigarette smoke. However, levels of toxicants can vary across brands and sometimes reach higher levels than in tobacco smoke. (WHO, 2016) The evidence suggests that the health risks posed by e-cigarettes are relatively small by comparison [to tobacco] but the long-term effects should be continued to be studied. (McNeill, 2015). EUROPEAN AND UK LEGISLATIVE CONTEXT Tobacco and Related Products Regulations 2016 will require that from 20 May 2017: All e-cigarette products to be child and tamper proof The contents of e-cigarette substances are declared on the label and are submitted to regulators prior to sale of the product. Health warnings about the addictiveness of nicotine must appear on e- cigarette packaging E-cigarette advertising on television, radio, and in newspapers and magazines is restricted. The strength of nicotine in e-liquid and the size of e-liquid containers are limited. Additional ingredients such as vitamins, minerals, caffeine and taurine are banned. INTERNATIONAL POLICY CONTEXT A number of national and international bodies have produced statements or reports on ENDS, this includes the World Health Organisation; the US Food and Drug Administration and US Surgeon General; Public Health England and the Royal College of Physicians. While there is some consistency between the views of these organisations there are also substantial differences and it is increasingly clear that the public is confused about the status of ENDS and their relative benefits and safety. In drafting this position statement Public Health Wales has sought to navigate a path through this controversy that recognises that there are both potential benefits and harms from the use of ENDS. The recent output from the US Food and Drug Administration below summarises the position well: VERSION 0.8 Public Health Wales Position on Electronic Nicotine Delivery Systems Page 5 of 6

13 The Food and Drug Administration believes that this new technology [ENDS] has both potential benefits and risks. If [...] e-cigarettes, have reduced toxicity compared to conventional cigarettes; encourage current smokers to switch completely; and/or are not widely used by youth, they may have the potential to reduce disease and death. But if [they] prompt young people to become addicted to nicotine, reduce a person s interest in quitting cigarettes, and/or lead to long-term usage with other tobacco products, the public health impact could be negative. (US Federal Drug Administration, 2016) The commercial interests of tobacco transnational companies (TTC) should not be under-estimated in relation to ENDS, and their increasing share of the market is noted by many as a major threat to tobacco control. The TTCs are making efforts to promote ENDS as a complement (not an alternative) to tobacco; promote smoking through ENDS advertising/promotion; and assert ENDS benefits to engage and influence policy and undermine tobacco control efforts. For more information, please contact: publichealth.policy@wales.nhs.uk REFERENCES 1. (FDA) U.S Food and Drug Administration, 2016 The Facts on the FDA s New Tobacco Rule Accessed at: Last accessed: 25/08/16 2. Hartmann-Boyce, J., et al, Electronic cigarettes for smoking cessation, Cochrane Database of Systematic Reviews. Accessed at: Last accessed: 14/10/16 3. McNeill A, Brose LS, Calder R, et al, E-cigarettes: an evidence update - A report commissioned by Public Health England. UK Centre for Tobacco & Alcohol Studies Accessed at: ettes_an_evidence_update_a_report_commissioned_by_public_health_england_final.pdf Last accessed: 28/07/16 4. (RCP) Royal College of Physicians, Nicotine without smoke: Tobacco harm reduction. London, UK: Royal College of Physicians. Accessed at: Last Accessed: 02/11/16 5. Welsh Government, Welsh Health Survey 2015 Current Release Accessed at: Last Accessed: 02/11/16 6. World Health Organisation, Electronic nicotine delivery systems and Electronic Non- Nicotine Delivery Systems (ENDS/ENNDS) Accessed at: Last accessed: 6/10/16 VERSION 0.8 Public Health Wales Position on Electronic Nicotine Delivery Systems Page 6 of 6

14 Background Paper Updated Position Statement on E-Cigarettes Background Paper Updated Position Statement on Electronic Nicotine Delivery Systems Author: Dr. Julie Bishop, Director of Health Improvement; Ashley Gould, Consultant in Public Health; Dr. Teri Knight, Consultant in Public Health; Sian Price, Head of Observatory Evidence Service; Adam Jones, Public Health Practitioner Policy; Kate Heneghan, Advanced Evidence Knowledge Analyst; Dr. Sumina Azam, Consultant in Public Health Date: 11 th January 2017 Version: 1.0 Publication/ Distribution: Public (Internet) NHS Wales (Intranet) Public Health Wales (Intranet) Review Date: Position statement to be subject to regular reviews, twelve months from publication or on emergence of significant new evidence. Purpose and Summary of Document: This document notes the current national and international position with respect to the public health role of ENDS (e-cigarettes). It summarises global developments in policy, evidence and legislation since development of the initial organisational Position Statement, and proposes content for a revised Position Statement. Work Plan reference: Strategic Priority 5 Position Statement PRID/S/003 Date: 11/01/2017 Version: 1.0 Page: 1 of 49

15 Glossary ASA ASH BCAP CAP DoH EC ENDs ENNDs EU FCTC FDA FPH MHRA NRT NVPs PHE RCP RSPH TPD Advertising Standard Authority Action on Smoking and Health Broadcast Committee of Advertising Practice Committee of Advertising Practice Department of Health European Commission Electronic Nicotine Delivery Systems Electronic Non-Nicotine Delivery Systems European Union WHO Framework Convention on Tobacco Control U.S Food and Drug Administration Faculty of Public Health Medicines and Healthcare products Regulatory Agency Nicotine Replacement Therapy Nicotine Vapour Products Public Health England Royal College of Physicians Royal Society for Public Health Tobacco Products Directive TRPR Tobacco and Related Products Regulations 2016 WHO WHO-E World Health Organization World Health Organization European Region Date: 11/01/17 Version: 1.0 Page: 2 of 49

16 Percentage Public Health Wales 1 Introduction Electronic cigarettes, or e-cigarettes, including e-pens, e-pipes, e-hookah, and e-cigars are known collectively as ENDS electronic nicotine delivery systems. ENDS deliver nicotine within an inhalable aerosol by heating a solution that typically contains nicotine, propylene glycol and/or glycerol, plus flavours. This aerosol is commonly referred to as vapour and so the use of an ENDS is described as vaping. Unlike cigarettes, there is no direct combustion involved in ENDS so there is no smoke and no other harmful products of tobacco combustion, such as tar and carbon monoxide. ENDS appeared in the UK around 2005 and growth in their use has been essentially consumer-driven. It is estimated that there are currently 2.8 million e-cigarette users in Britain [49]. The Welsh Health Survey, 2015 noted 6% of adult respondents reported currently using ENDS and 15% having ever-tried them. This compares to 19% reporting they smoke, in the same national survey. 25 Welsh Health Survey 2015, Adults reporting e-cigarette usage, by age All aged Age Banding Currently use e-cigarettes Ever used e-cigarettes Figure 1 Adults reporting e-cigarette use, by age, WHS Date: 11/01/17 Version: 1.0 Page: 3 of 49

17 Percentage Public Health Wales Welsh Health Survey 2015, Adults reporting e-cigarette usage, by Health Board BCUHB HDUHB PtHB ABMUHB CTUHB C&VUHB ABUHB Wales Health Board/Wales 15 Currently use e-cigarettes Ever used e-cigarettes Figure 2 Adults reporting e-cigarette use, by Health Board, WHS Figure 1 indicates the highest levels of experimentation are reported in the age band and current use of 8% in the bands covering 25 to 54 year olds. In terms of geographical distribution Figure 2 indicates slightly lower rates of ever-use in the predominantly rural Health Boards of Powys and Hywel Dda, with only 3% of Powys adults reporting current use, compared to 5% or 6% in each of the other Board areas. ENDS continue to be something of a public health controversy across the globe and evidence of harms and benefits and discourse around their use is rapidly evolving. Some jurisdictions, such as Canada and Australia prohibit the sale of ENDS not licensed as medicines. By contrast, England has a progressive stance with a harm reduction emphasis for existing tobacco smokers. Public Health Wales has adopted a balanced benefit-harm evidence-based but precautionary approach thus far. In terms of external output, Public Health Wales issued a Position Statement on ENDS in December 2013 (Appendix A), and offered written and oral evidence to the Welsh Assembly Health and Social Care Committee hearing on the Public Health (Wales) Bill in August 2015 (included in Appendix B). A more comprehensive chronology of key developments is included as Appendix B. The organisational position has evolved as outlined above with growing knowledge and evidence, but the initial formal position statement has not been updated. The rapid evolution of the ENDS market, cultural responses to the products and the rapid growth of literature around them necessitate a more formal review and revision of the formal organisational position. The UK E-Cigarette Research Forum (facilitated by Cancer Research UK and Public Health England) highlight an average of 30 new studies being published each month, so rather than dissecting the entire literature and Date: 11/01/17 Version: 1.0 Page: 4 of 49

18 duplicating the work of others, this Background Paper aims to synthesise review level material from other established public health organisations, legislative and regulatory controls, and local and global contexts, to inform a proposed revised Position Statement on ENDS for Public Health Wales. 1.1 Population level impact of ENDS As noted in the current organisational Position Statement ENDS present both potential benefits and potential harms, the fair distribution of these across the population is critical, and by necessity will involve some tradeoffs. To help maximise the potential benefits of ENDS to smokers and also to help minimise risks to non-smokers a systematic assessment of the benefits, harms both to individuals and at a population level has been undertaken. The assessment related to four distinct groups, building on those used in the current Position Statement (Appendix A) but disaggregating children and young people, from adults who do not smoke. This approach follows increasing evidence of the long-term consequences of nicotine exposure in children, and organisational positioning and the wellrehearsed and multi-faceted benefits flowing from efforts to protect and improve the health of children and young people specifically. The groups are: Children and young people who do not smoke Non-smoking general population Smokers who wish to quit Committed smokers unwilling or unable to quit 2 Views of other Public Health Organisations and bodies Public Health England (PHE) s first major commissioned report on E- Cigarettes was released in May 2014 [8], alongside a review of uptake and marketing of the products [9]. An evidence update was subsequently commissioned in August 2015 [10], supported by a short briefing paper on the foundations for evidence-based policy and practice [11]. This paper considered the findings of the evidence review, and advised that e- cigarettes had the potential to help smokers to quit whilst highlighting that they were also not risk free. In addition, the paper suggested that local stop smoking services should actively engage with smokers who want to quit with the help of e-cigarettes, though the conclusion also highlighted the fact that there was not a medicinally-regulated product available to the NHS. In July 2016, PHE issued a joint statement, authored in partnership with twelve other UK organisations [12]. In this statement, the organisations state their agreement that e-cigarettes are significantly less harmful than smoking, going on to say that All the evidence suggests that the health Date: 11/01/17 Version: 1.0 Page: 5 of 49

19 risks posed by e-cigarettes are relatively small by comparison but we must continue to study the long-term effects. On a similar note, the documents published in 2014 and 2015 consider factors such as device safety, nicotine addiction and ingredient composition within the e-liquids. Alongside this statement, PHE published a document providing advice on the use of e-cigarettes in public places and workplaces [13]. This document sets out 5 key principles to help organisations develop their own policies, which are: 1. Make clear the distinction between vaping and smoking; 2. Ensure policies are informed by the evidence on health risks to bystanders; 3. Identify and manage risks of uptake by children and young people; 4. Support smokers to stop smoking and stay smokefree; 5. Support compliance with smokefree law and policies. In Scotland, NHS Health Scotland published a position paper in November 2015 regarding e-cigarette use in NHS Scotland [14]. This followed an earlier position statement published in 2014, and related to the advice published by Scottish Directors of Public Health and Scottish Health Promotion Managers [15]. As with PHE s reports and statements, these Scottish position statements highlight the potential that e-cigarettes have for helping smokers to quit smoking, whilst also highlighting the fact that e- cigarettes are not risk free. In April 2016, the Royal College of Physicians (RCP) published a substantial report on tobacco harm reduction, which included extensive coverage of the emerging evidence related to e-cigarettes, alongside that of traditional nicotine replacement therapy (NRT) [1]. The report featured a substantial section on nicotine pharmacology and pathophysiology and in relation to toxicology the report asserts that Although nicotine is a toxic compound, overdosing on nicotine products used as directed is almost impossible, given the individual ability to titrate dose and the short half-life of nicotine. The report also notes that At commonly used dose levels, short-term nicotine use does not result in clinically significant harm. [and] Evidence about long-term nicotine or NRT use is relatively scarce. The report concludes that e-cigarettes are almost as effective in preventing harm as [if the smoker] switch[ed] to NRT [2]. Measures aimed at reducing the risk of accidental nicotine poisoning, in children and young people particularly, were contained in the Tobacco Products Directive, and enacted in the Tobacco and Related Products Regulations. Details on the provisions are outline in Section 3 below. Date: 11/01/17 Version: 1.0 Page: 6 of 49

20 Twelve UK public health organisations (Action on Smoking and Health (ASH), the Association of Directors of Public Health, British Lung Foundation, Cancer Research UK, Faculty of Public Health (FPH), Fresh North East, Healthier Futures, Public Health Action, Royal College of Physicians (RCP), Royal Society for Public Health (RSPH), UK Centre for Tobacco and Alcohol Studies and UK Health Forum) were co-signatories to the joint statement issued by Public Health England in July 2016 [12] (more detail of which is referred to in section 2.5 of this document) International Organisations The World Health Organization (WHO), through its Framework Convention on Tobacco Control (FCTC), published a report into ENDS in 2014, following a request made at the FCTC Conference of the Parties (COP) (which includes the UK as a signatory to the framework convention), in At the 2014 COP meeting, the requested report was presented [16]. It explored emerging evidence on the health impacts of ENDS, as well as identifying options for their prevention and control. For reporting purposes, the findings were categorised into three groups: the health risks to users and nonusers ; efficacy in helping smokers to quit smoking and ultimately nicotine dependence ; and interference with existing tobacco-control efforts and implementation of the WHO FCTC. The report looked into regulatory options, suggesting that ENDS products should be regulated for use within smoking cessation services, that ENDS users should not use ENDS indoors unless exhaled vapour is proven to be harmless to bystanders, and any advertising, promotion and sponsorship of ENDS should not appeal to children or non-smokers. In preparation for the next meeting in November 2016 the WHO recently published an update report on ENDS [3]. The report covers the potential role of ENDS in smoking cessation and their impact on tobacco control efforts. Headline messages from the report include: Recognition that ENDS are a diverse group [of products] with potentially significant differences in the production of toxicants and delivery of nicotine which clearly impacts their benefit/harm potential. These differences unpin the observation that coordinated use of chemical, in vitro, clinical and epidemiological methods are needed to improve the evidence around health effects. The majority of smokers unwilling/unable to quit switching to ENDS (and eventually stopping using ENDS) would represent a significant contemporary public health achievement as long as recruitment into the nicotine-dependant population is no higher than it is for smoking The number and level of toxicants generated by using ENDS is on average lower or much lower than in cigarette smoke, and they Date: 11/01/17 Version: 1.0 Page: 7 of 49

21 conclude that ENDS are less toxic than cigarette smoke. However, it is noted that levels of toxicants can vary across brands and sometimes reach higher levels than in tobacco smoke For specific high risk groups such as children and adolescents, pregnant women, and women of reproductive age the WHO conclude that the evidence is sufficient to warn [...] against ENDS use The report references an unpublished WHO-Commissioned review into exposure to exhaled aerosol from ENDS, concluding that second hand aerosol (SHA) is a new air contamination source for particulate matter [...] some VOCs [and] some heavy metals... The report notes that levels of nickel and chromium are higher in SHA from ENDS than in second hand smoke and certainly background air, but the magnitude of the associated risks to health are unknown. No definitive conclusion is reached on the utility of ENDS in helping smokers quit because of the low quality of current scientific evidence. In relation to prevalence of ENDS use in people under 20 years of age, the report references the only available probability sample surveys from USA, Poland and Italy. From this it proposes two groups of countries one where use is low and not increasing significantly (Italy, and the report suggests England too), and another where prevalence is rapidly increasingly (Poland and USA). The report identifies fruit and confectionary flavours as appealing to children, younger never-smokers and young ENDS beginners and may therefore play a role in motivating experimentation among them. However it also notes the role flavours play in helping migration away from tobacco. The commercial interests of tobacco transnational companies (TTC) is highlighted, and their increasing share of the marketed is noted as a major threat to tobacco control as the TTCs make efforts to promote ENDS as a complement (not an alternative) to tobacco; promote smoking through ENDS advertising/promotion; and assert ENDS benefits to engage and influence policy and undermine tobacco control efforts. It is worth noting here that the tobacco industry has been consolidating the ENDS market and all the large tobacco multinationals are now active in this sector [9]. The WHO report suggests that increased regulation will force further market concentration and so allow tobacco multinationals to increase their market dominance. Date: 11/01/17 Version: 1.0 Page: 8 of 49

22 2.2 Other relevant evidence New Regulations for E-Cigarettes U.S. Food and Drug Administration [39] In August 2016 the US Food and Drug Administration (US FDA) adopted new regulatory controls that extended their authority to include electronic nicotine delivery systems, in the purview of regulations previously only applied to tobacco. The Regulations include nicotine warning statements to feature on packages, and in advertisements; and restrictions focused on improved safety in the manufacture, processing, import and sale of ENDS. In summary: The FDA believes that this new technology [ENDS] has both potential benefits and risks. If [...] e-cigarettes, have reduced toxicity compared to conventional cigarettes; encourage current smokers to switch completely; and/or are not widely used by youth, they may have the potential to reduce disease and death. But if [they] prompt young people to become addicted to nicotine, reduce a person s interest in quitting cigarettes, and/or lead to long-term usage with other tobacco products, the public health impact could be negative. [39] E-Cigarette Use Among Youth and Young Adults: A Report of the Surgeon General [50] In light of a 900% increase in ENDS use among high school students from 2011 to 2015, and the vulnerability of the brain of youth/young adults to the negative consequences of nicotine exposure, this report details current U.S. Department of Health and Human Services knowledge around ENDS. It acknowledges the gaps in scientific evidence, and that the products and patterns of use continue to change quickly. The Surgeon General, in his Foreword concludes To prevent and reduce the use of e-cigarettes by youth and young adults, we must [...] implement proven prevention and education strategies. The report also details the Departments current understanding around the health effects of inhaling vapour from ENDS concluding that this is not harmless water vapour [sic], although it generally contains fewer toxicants than combustible tobacco products., and suggests the need for further measurement/study of second-hand, and third-hand (deposited constituents of) ENDS aerosol. The report includes a call to action and offers a list of goals and evidence-based strategies designed to reduce the public health threat posed by e-cigarette use among youth and young adults. These goals are: Goal 1. First, Do No Harm Strategy 1A. Implement a comprehensive strategy to address e- cigarettes that will avoid adverse consequences and give careful consideration to the risks for youth and young adults. This can be done by Date: 11/01/17 Version: 1.0 Page: 9 of 49

23 including e-cigarettes in policies and programs related to conventional cigarette smoking at the national, state, local, tribal, and territorial levels. Strategy 1B. Provide consistent and evidence-based messages about the health risks of e-cigarette use and exposure to second hand aerosol from e-cigarettes. Goal 2. Provide Information About the Dangers of E-Cigarette Use Among Youth and Young Adults Strategy 2A. Educate parents, teachers, coaches, and other influencers of youth about the risks of e-cigarette use among youth and young adults. Strategy 2B. Educate health professionals about the risks of e- cigarette use among youth and young adults. Goal 3. Continue to Regulate E-Cigarettes at the Federal Level to Protect Public Health Strategy 3A. Implement FDA regulatory authority over the manufacturing, marketing, and distribution of e-cigarettes. Strategy 3B. Reinforce other federal agencies as they implement programs and policies to address e-cigarettes. Goal 4. Promote Programs and Policies at the State and Local Levels to Prevent E-Cigarette Use Among Youth and Young Adults Strategy 4A. State, local, tribal, and territorial governments should implement population-level strategies to reduce e-cigarette use among youth and young adults, such as including e-cigarettes in smoke free indoor air policies, restricting youth access to e-cigarettes in retail settings, licensing retailers, and establishing specific package requirements. Strategy 4B. Coordinate, evaluate, and share best practices from state and local entities that have implemented programs and policies to address e-cigarette use among youth and young adults. Goal 5. Curb Advertising and Marketing that Encourages Youth and Young Adults to Use E-Cigarettes Strategy 5A. Curb e-cigarette advertising and marketing that are likely to attract youth and young adults. Strategy 5B. Urge the e-cigarette companies to stop advertising and marketing that encourages and glamorizes e-cigarette use among youth and young adults. Date: 11/01/17 Version: 1.0 Page: 10 of 49

24 Goal 6. Expand Surveillance, Research, and Evaluation Related to E- Cigarettes Strategy 6A. Improve the quality, timeliness, and scope of e- cigarette surveillance, research, and evaluation. Strategy 6B. Address surveillance, research, and evaluation gaps related to e-cigarettes. 3 Legislative and Regulatory Context Note: This section of the document refers to the current legislative framework, with the UK as a member of the European Union (EU), and therefore party to relevant European regulations and legislation. As the UK has voted to leave the EU, this section will be revised as soon as any new arrangements are clarified. 3.1 Tobacco Products Directive 2014/14/EU (TPD) The Tobacco Products Directive 2014/14/EU (TPD) [17], which came into force on 20 th May 2016, introduces new rules for nicotine-containing e- cigarettes and refill containers (Article 20). The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for implementing the majority of provisions under Article 20 throughout the UK, and has issued details guidance on this [18]. The TPD introduces new rules, to ensure: minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids); that information will be provided to consumers so that they can make informed choices; Development of an environment that protects children from starting to use these products. The TPD covers products which contain less than 20 mg/ml of nicotine and have not opted into medicinal licensing. These will be regulated as consumer products and be subject to the following restrictions: Products must be child and tamper-proof; Health warnings, instructions for use, information on addictiveness and toxicity must appear on the packaging and accompanying information leaflet; There can be no promotional elements on packaging; All ingredients and the nicotine content must be listed; Existing rules for the cross-border marketing of tobacco products will apply to electronic cigarettes, in effect banning any advertising which Date: 11/01/17 Version: 1.0 Page: 11 of 49

25 has a cross-border effect. The TPD leaves it to Member States to decide whether to regulate domestic advertising; Manufacturers must inform Member States before placing a product on the market and must report annually to Member States; and There will be new size limits on products: 10ml for e-liquids for dedicated refill containers and 2ml for electronic cigarette cartridges and tanks. The TPD does not harmonise rules within EU Member States over the following aspects: nicotine-containing products that are authorised as medicines; nicotine-free products such as disposable e-cigarettes containing nicotine-free liquids, or cartridges that contain nicotine-free liquids; smoke-free environments; domestic sales arrangements; domestic advertising; flavourings; Age restrictions Restrictions on Sale and Marketing New regulations were introduced on the 1 st October 2015 preventing the sale of e-cigarettes to under 18s and proxy purchasing (the purchase by adults for those under 18) (13). Following the introduction of the TPD (as enacted by UK regulations), retailers have until 20 May 2017 to sell through stock of products that do not comply with the labelling and product composition requirements. Article 20(5) of the TPD relates to restrictions on the advertising of e- cigarettes. The TPD restricts any forms of marketing which may have a cross-border effect within the EU, but leaves it to EU Member States to decide whether to regulate domestic advertising - in the UK, these rules have been implemented in the Communications Act 2003 [19], amendments to the UK Code of Broadcast Advertising (the BCAP Code) and Broadcast Code [20], and in the Tobacco and Related Products Regulations 2016 [21]. According to the DoH, which is orchestrating the UK-wide response to the TPD, the rules within Article 20(5) mean that e-cigarettes and refill containers cannot be advertised or promoted, directly or indirectly, on TV or on-demand TV, radio, internet advertising, commercial or in certain printed publications, including newspapers and magazines. Article 20(5) also prohibits the sponsorship of television and radio programmes which promote e-cigarettes and product placement of e-cigarettes [22]. Whilst these restrictions may seem extensive, they are not as stringent as marketing restrictions on traditional cigarettes, which are party to a total ban on advertising and sponsorship in all mediums. For example, advertising of Date: 11/01/17 Version: 1.0 Page: 12 of 49

26 ENDS in cinema, via fax, outdoor posters, posters on sides of buses, leaflets, and direct hard copy mail are still permitted. The DoH states quite clearly that it has taken a minimal approach to the implementation of Article 20(5) and has provided a summary table of restrictions and permissions in relation to e-cigarette marketing [22], which is also replicated within Appendix C of this document. The Committee of Advertising Practice (CAP) has recently consulted on amendments to their Code, in light of both the TPD and the UK Parliament s Tobacco and Related Products Regulations 2016 [23] Enforcement of Advertising and Marketing Regulations The chapter on The Tobacco and Related Products Regulations 2016 explains this in more detail, but, in short, OFCOM will enforce the rules for broadcast media and trading standards will enforce the non-broadcast media rules with the Advertising Standard Authority (ASA) undertaking a first line self-regulatory check on the industry. OFCOM have published a statement [24] which outlines the amendments made to the Broadcast Committee of Advertising Practice (BCAP) Code, changes which came into effect on 20 th May 2016, alongside a separate statement which outlines the approach to regulating e-cigarette product placement and sponsorship on broadcast television and on-demand catch-up services [25]. The CAP Consultation on changes to the regulation of e-cigarette advertising [23] aims to explore how they will reflect the law in their guidance Scotland The Scottish Parliament has introduced new legislation [26] which expands upon the minimum restrictions introduced by the UK Government. The scope of legislation covers both nicotine and non-nicotine vapour products, which is an expansion on the nicotine-only restrictions introduced via the DoH, which are the minimum required by the TPD. The Health (Tobacco, Nicotine, etc. and Care) (Scotland) Act 2016 enables Scottish Ministers (via the development of further regulations) to prohibiting or restricting activities relates to nicotine vapour product advertising and brandsharing Safety of E-Cigarettes Following the introduction of the TPD, the MHRA has been designated as the competent authority for the notification scheme for e-cigarettes and refill containers in the UK. One of the new rules that the TPD introduces relates to minimum standards for the safety and quality of all e-cigarettes and refill containers (e-liquids). This regulation refers to producers of these products Date: 11/01/17 Version: 1.0 Page: 13 of 49

27 a producer is defined as is anyone who manufactures or imports these products or who re-brands any product as their own [18]. Producers must submit information about their products to MHRA. In light of the new regulations, producers of new e-cigarette and refill container products will need to submit a notification to MHRA 6 months before they intend to put their product on the UK market. Draft guidance for producers on product types, submissions, emissions testing, nicotine dose and UK ingredients has been published on the MHRA webpage [18]. The TPD obliges emissions testing from all notified products to be carried out, with a particular requirement for acetaldehyde, acrolein and formaldehyde emissions to be submitted in all cases [27]. In relation to nicotine dosage, EU member states are obliged to ensure that the dose of nicotine delivered by an e-cigarette is delivered at a consistent level. However, full clinical testing will not be required an example of measurement of the weight of nicotine in...e-cigarette vapour is described as adequate in the draft guidance [28]. A report from the European Commission (EC) in May 2016 [29] found that the provisions around safety present within the TPD, and the associated secondary legislation introduced within national legislatures, provides an adequate and proportion framework to mitigate risks related to refill cartridges. (See Section 6.2 for further commentary related to this report). 3.2 The Tobacco and Related Products Regulations 2016 The Tobacco and Related Products Regulations 2016 (TRPR) became law in the UK on Friday 20 May These regulations relate to domestic advertising restrictions, in light of the TPD. The Explanatory Memorandum for the TRPR [30] explains that the Regulations implement the majority of provisions outlined within the TPD. In the context of e-cigarettes, the TRPR regulates electronic cigarettes and associated refill cartridges (notification of placing on the market, adverse event monitoring, product standards, labelling and advertising) [30] and, in relation to enforcement, explains that: The rules for advertising electronic cigarettes will be enforced by the agencies which currently enforce the rules on tobacco advertising. OFCOM will enforce the rules for broadcast media and trading standards will enforce the non-broadcast media rules with the Advertising Standard Authority undertaking a first line self-regulatory check on the industry. (UK Parliament. Explanatory Memorandum to The Tobacco and Related Products Regulations 2016, para 4.9, p3.) Date: 11/01/17 Version: 1.0 Page: 14 of 49

28 In relation to the regulations related to labelling and consumer protection, these will be enforced by Trading Standards Officers (or Environmental Health Officers in Northern Ireland). The Committee of Advertising Practice (CAP) has recently consulted on amendments to their Code, in light of the UK Government s Tobacco and Related Products Regulations [25] 4 Other UK Legislation 4.1 Health (Tobacco, Nicotine, etc. and Care) (Scotland) Act 2016 The Health (Tobacco, Nicotine, etc. and Care) (Scotland) Act referred to for the rest of this section as the Act is the first legislative act relating to nicotine vapour products (NVPs) in Scotland. The Policy Memorandum accompanying the Bill [31] on its introduction to the Scottish Parliament outlines the rationale for the, at the time, proposed legislation: The Scottish Government is legislating for the first time on NVPs, which pose both potential challenges and opportunities for public health, internationally and within Scotland. NVPs can come in two forms: those which deliver nicotine to the user and those which do not. The Scottish Government s approach to NVPs is in part precautionary, in that it aims to limit the likelihood of potential future negative impacts on the health of individuals, for population health and for tobacco control. (Scottish Government. Health (Tobacco, Nicotine Etc. and Care) (Scotland) Bill - Policy Memorandum, 4 June 2015, page 2) Following a Scottish Government consultation [32] to garner stakeholder opinions on enhancing the restrictions proposed within the TPD, the final Act includes the introduction of age restrictions for purchasing e-cigarettes (18yrs old+), powers to prohibit proxy purchasing for under 18s, a new power to prohibit sale from vending machines, and a register of retailers who will also need to operate an age verification policy at the point of sale. Further provisions within the Act seek to control the advertising and promotion of NVPs, which aims to restrict marketing, but could also go as far as to prohibit domestic advertising and promotions. The Explanatory Notes accompanying the Act provide further detail of the new powers introduced into law. Regarding Section 17(1) of the Act, the Notes explain that this section contains a wide power for the Scottish Ministers to make regulations to prohibit or restrict advertising and brandsharing of NVPs. ([33], page 10). Date: 11/01/17 Version: 1.0 Page: 15 of 49

29 4.2 Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 and the Proxy Purchasing of Tobacco, Nicotine Products etc. (Fixed Penalty Amount) Regulations 2015 Under the above Regulations, from 1st October 2015, it became illegal to sell e-cigarettes or e-liquids to children under the age of 18 and the proxy purchase of both tobacco and e-cigarette products also became illegal, authorised medicinal products are exempted. Retailers will need to check that a person is over the age of 18 before selling them e-cigarettes or associated products, such as refill cartridges and batteries, or they could receive an on the spot fine of 50. Proxy purchasing the process of an adult buying an age restricted product on behalf of someone who is underage of tobacco and e-cigarettes will incur fines in line with those already in place for alcohol. The fines in place for the proxy purchase of an age restricted product include a fixed penalty of 90 and up to 2,500 on conviction. 5 Horizon Scan of Future Developments A WHO Review of the data on the prevalence and trends of ENDS use among people of 20 years of age or less is due to be published later this year. This review has looked into 27 studies using probability sampling, and will show that from , the use among non-smokers is around 2% [30, cited in 3]. Regulatory options for countries who have ratified the WHO s FCTC are considered in the latest report to be presented at COP7 [3]. Alongside existing regulations in operation within the UK (e.g. banning sale and distribution to minors; restricting advertising, promotion and sponsorship), the report suggests consideration of other options, including taxation of products to make them unaffordable to minors, and banning or restricting the use of flavours that appeal to minors [3, p6]. The report also states an objective to minimise as far as possible any potential health risks to users of e-cigarettes, and protect non-users from exposure. Regulatory options proposed for this are largely in line with the restrictions present within the TPD, including regulating electrical and fire safety standards of ENDS devices, regulating labelling of devices and e- liquids Date: 11/01/17 Version: 1.0 Page: 16 of 49

30 6 Government Reports and Strategies 6.1 Europe The European Commission published a report in 2015 on the attitudes of Europeans towards tobacco and electronic cigarettes [35]. The survey behind this report, conducted in 2014, found that 12% of Europeans had tried e-cigarettes, with this number increasing from 7% in Other findings include: Flavour (39%) and price (38%) were the main reasons for choosing a particular e-cigarette; followed by the amount of nicotine it contained (27%). Two-thirds of respondents to the survey (67%) started using e- cigarettes in order to reduce their tobacco use, or to stop smoking. 44% of respondents smoke e-cigarettes where tobacco smoking is restricted, and 24% claimed to smoke e-cigarettes because they are seen as attractive, cool or fashionable. Only 14% of respondents stated that using e-cigarettes helped them to quit smoking completely; 21% reduced their tobacco consumption but didn t quit, and 13% said that e-cigarettes had helped them to quit, only for them to resume smoking later. 52% of respondents thought that e-cigarettes were harmful; this is an increase on the 27% who thought this in the 2012 survey. 63% of Europeans surveyed believed that e-cigarettes should be banned in places where smoking is prohibited. A May 2016 report from the European Commission looked into the potential risks to public health associated with refillable e-cigarettes and their containers [29]. This short report does not look into the wider public health impact of e-cigarettes in general. It lists four main risks related to the use of this type of e-cigarette, namely: Poisoning from ingesting e-liquids containing nicotine (especially for young children); Skin reactions related to dermal contact with e-liquids containing nicotine and other skin irritants; Risks associated with home blending; and Risks due to using untested combinations of e-liquid and device or hardware customisation. Ideas on how to mitigate these four risks are also provided within the report. The authors conclude that the measures introduced within the TPD, and the associated secondary legislation introduced within national legislatures, provides an adequate and proportion framework to mitigate risks related to refill cartridges. Nevertheless, they also call for further studies into product Date: 11/01/17 Version: 1.0 Page: 17 of 49

31 safety, emissions testing and safety of flavours, along with awarenessraising amongst citizens of the toxicity of e-liquids. 7 Global Perspectives by country The Institute for Global Tobacco Control [36] hosts a database [37] of the policy levers, legislation and regulations in place around the world. The database highlights national laws regarding the regulation of sale, use, advertising, promotion, taxation and/or the classification of ENDS. Similarly, Tobacco Control Laws[38], established by a US charity Tobacco Free Kids, hosts extensive detail of legislation around the world on all aspects of tobacco control, as well as details of litigation by/against the tobacco industry. In this section, key legislative and regulatory developments are highlighted in three countries which featured prominently in the evidence review. 7.1 United States of America The United States has yet to ratify the WHO Framework Convention on Tobacco Control, so is therefore not party to it. A recent development in the US is the introduction of a new regulation, effective from 8 August 2016 throughout the United States, which extends the statutory definition of tobacco product to include ENDs (of which the wide definition includes, for the purposes of this document, e-cigarettes). The U.S Food and Drug Administration (FDA) have summarised this new ruling [39]. The new rule requires health warnings on tobacco products, bans the distribution of free samples and manufacturers of all regulated tobacco products will have to show that their products meet a public health standard. Appendix B presents a breakdown of sub-national laws regulating e- cigarettes within the U.S, as at September 2015 (in additional to subnational laws in China, India, Canada and Australia). The table is taken from a policy scan of sub-national laws [40]. In the U.S context, this shows distinct regulatory approaches to e-cigarette legislation within the nation. For example, the scan highlights age restrictions as a regulatory domain for these states, with, at the time, Arkansas and Indiana having a minimum age of 18 for the legal use of e-cigarettes, whereas New York and Hawaii had minimum age restrictions of 21 years old. Another example of different regulatory approaches within the United States is with taxation. In Minnesota, there is a state tobacco tax, which is 95% of the wholesale cost of a tobacco product (e-cigarettes and nicotinecontaining cartridges/e-liquids fall into this category), whereas Kansas has, Date: 11/01/17 Version: 1.0 Page: 18 of 49

32 since July 2016, a tax specifically for e-cigarettes, set at $0.20 per millilitre of consumable material and a proportionate tax on components. 7.2 New Zealand New Zealand has similar provisions in place as the UK, for an e-cigarette promoted as a therapeutic product to be classified as a medicine, which would then remove restrictions on their sale, advertising and distribution. It is illegal to make a claim for therapeutic benefit without the e-cigarette product being licensed as a medicine. At the time of writing, no e-cigarettes have been approved as a medicine or smoking cessation aid under the provisions outlined in the Medicines Act 1981 [41]. The Smoke-Free Environments Act 1990 [42] regulates e-cigarettes as tobacco products, which places prohibition on sale. This Act also bans the use of e-cigarettes in public places where the use of traditional tobacco products are banned. In addition, products that look like tobacco products (such as toy tobacco products), that could simulate smoking, are banned from sale to persons under 18 years of age. 7.3 Mexico In Mexico, their Ley General Para El Control Del Tabaco 2008 [43] (General Law on Tobacco Control 2008) prohibits the sale, distribution, promotion and manufacture of an object that could be seen to imitate a tobacco product. Nevertheless, it has been reported [44] that Mexico s Supreme Court of Justice endorsed the free sale of e-cigarettes in September 2015, to protect a person who was fined under the regulations that the above law imposes. (An unofficial translation of this legislation has been provided to the tobaccocontrollaws.org website by a Mexican Health Ministry official [45]) 8 Global Perspectives by policy/legislative/regulatory domains As with Section 7, the websites of the Institute for Global Tobacco Control [37] and Tobacco Control Laws [38] have been searched for links to examples of global approaches to restricting and regulating e-cigarette use by specific domains. This section highlights examples by each domain relevant to this policy background paper. Date: 11/01/17 Version: 1.0 Page: 19 of 49

33 8.1 Age Restrictions In the United States, a national minimum age for use of e-cigarettes is set at 18 years old; however individual states have increased the minimum age for their use. For example, Hawaii and New York both have their minimum age set at 21 years old. Other nations to have a minimum age for sales of e-cigarettes set at 18 years old include France, Italy, New Zealand and Spain. Minimum age for purchase is set at 19 years old in South Korea, and 21 years old in Honduras. 8.2 Advertising, Promotion and Sponsorship A total of 33 countries prohibit or restrict the advertising, promotion or sponsorship of e-cigarettes. These include Australia, Canada, France, and Japan. Argentina and Australia link these restrictions to bans on sale. 8.3 Taxation Togo taxes e-cigarettes to a maximum of 45 percent, whilst South Korea applies a special health tax to e-cigarettes. proportional to USD 1.65 per ml nicotine liquid. 8.4 Restrictions on use in public places (incl. smokefree areas) Enclosed Public Spaces In addition to New Zealand (see 8.2), the use of e-cigarettes in public spaces (including bars, restaurant and workplaces) is banned in fifteen countries, including Belgium, Colombia and South Korea Public Transportation Nineteen countries have banned the use of e-cigarettes on public transport, including Belgium, Spain and South Korea. Three countries only restrict e-cigarettes on certain public transport vehicles, or allow non-nicotine e- cigarettes to be used. 8.5 Product Classification There is a wide range of different classification categories for e-cigarettes and their derivatives. Countries where an e-cigarette is able to be classed as a medicine if it contains nicotine include Canada, Japan and New Zealand. In Australia, e-cigarettes that are not classified as a medicine Date: 11/01/17 Version: 1.0 Page: 20 of 49

34 are considered a restricted poison. Israel considers e-cigarettes as consumer products, whereas EU-region countries, following the introduction of the TPD, classify them as consumer products if they do not make smoking cessation claims. 8.6 Restriction on Sale Twenty-six countries have banned the sale of e-cigarettes, including Brazil, Turkey and Thailand. Restrictions on sale are present in EU countries, as well as countries such as Australia, Canada and Japan. 8.7 Summary of global perspectives Section 7 and 8 on global perspectives confirm the complexity (and controversy) surrounding ENDS in terms of the range of products, of potential benefits, of potential harms, and of the emerging approaches to maximising the former and minimising the latter. The available evidence on these factors suggests that the debate is far from over and questions remain about ENDS benefits and harms. This equipoise dictates that the precautionary principle should apply, but alongside this the potential contribution ENDS can have to reducing tobacco related harm today cannot be passed-up, and as the World Health Organisation identify, ENDS use by smokers could represent a significant contemporary public health achievement. [3] The international policy position points towards an approach to ENDS based on segmentation of the population in Wales starting with smokers and non-smokers, and then further disaggregating to groups, based on the available evidence. This approach can form the foundation for development of policy and action to maximise potential benefits and minimise potential harms of ENDS, to deliver improved population health. 9 Evidence Review A pragmatic approach has been adopted to the review of evidence for this background paper. The dynamic and rapidly evolving landscape of ENDS use is reflected in the volume of literature being published on ENDS (including that relevant to patterns of use, developments in devices, perceptions, emissions, constituents, use in harm minimisation, use in smoking cessation, around the effects of vapour on cells, second-hand effects, third-hand effects, through to that around ENDS policy). This output is significant and the task of reviewing this extensive body of literature at a single point in time would be overwhelming and rapidly out of date. Key existing review material, from credible sources, was identified and has been used for this report. Date: 11/01/17 Version: 1.0 Page: 21 of 49

35 In mapping the potential benefits and harms from e-cigarettes within the four key population groups identified in section 1.1; two key evidence gaps were identified. The first of these relates to children and young people who are not currently tobacco smokers. On a theoretical basis, the potential impact of widespread e-cigarette use on re-normalising smoking would be dependent in part on how children and young people view vaping is it seen as a behaviour related to smoking or something quite separate. The second relates to the potential impact of restrictions on e-cigarette use in indoor public spaces and the extent to which this might deter committed smokers from switching to an e-cigarette for harm reduction purposes. The Evidence Service has conducted evidence reviews in each of these areas and detailed reports are available. The search methodology relating to the above outstanding research areas included search terms, resources searched, and limits imposed. The searches were undertaken in two steps; firstly, resources were searched for systematic reviews, guidance and other high-level evidence only. Secondly, as numbers of high level evidence found were low the search was broadened to include all primary research studies, poster presentations, protocols, conference abstracts and other types of grey literature such as reports published on organisational websites. In relation to the first question only one study was identified. This was a small qualitative study undertaken in New Zealand. As a result of the lack of evidence in this area the Head of Research and the Director of Health Improvement secured funding through the Public Health Wales Pump Priming and Strategic Initiatives Fund, and issued a research proposal. This research contract has recently been let. In relation to the second question, two primary studies were found which were considered relevant. One modelled demand for e-cigarettes following a ban in public places, based on a survey of adult smokers. The second study modelled willingness-to-pay for e-cigarettes as an indication of demand based on whether they could be used indoors. Although of some relevance to the question the review concluded that there is a gap in the current evidence. 10 Conclusion and Recommendations Sections 2 to 8 above confirm, and attempt to summarise, the volume of legislative and evidence based policy development at national and international levels that have emerged since the original Position Statement was produced. This information has been synthesised in order to provide a summary statement of the potential benefits and potential harms for each of the four Date: 11/01/17 Version: 1.0 Page: 22 of 49

36 population groups identified. In each case a concluding statement is presented and followed by a proposed position statement arising from this conclusion Children and young people Public Health Wales has previously identified three potential risks to the health of children and young people who do not smoke. The first of these relates to the renormalisation of smoking. There remains a gap in the current evidence base in this area and further research is needed. The second is that use of ENDS will act as a gateway to tobacco use. The absence of longitudinal studies in this area means that it is very difficult to answer this question definitively. The available evidence suggests that ENDS use is associated with tobacco use. However, the relationship between the two is poorly understood. Restrictions on advertising of ENDS introduced by the Tobacco and Related Products Regulations will help minimise risk in this area, but there remain some media where advertising is still permitted. The third concern is that ENDS while presenting a lower health risk for existing smokers than tobacco use, are not safe. There is an international consensus that for non-smokers use of e-cigarettes represents a potential risk to health [3]. Unpublished and published surveys in Wales suggest that experimentation with ENDS is rising rapidly with the most recent surveys suggesting over 18% of young people have used ENDS. Regular use although low is increasing and there is growing evidence of use among non and never smokers (Moore G; personal communication). The WHO 2016 report notes that The evidence is sufficient to warn children and adolescents [...] against ENDS use and nicotine [3] The availability and popularity of flavoured e-cigarettes/liquids remains a concern insofar as availability of confectionary-type flavours particularly could facilitate nicotine addiction in youth. The US Surgeon General has recently referenced studies indicating that young adults who have ever used e-cigarettes begin their use with sweet flavours rather than tobacco flavours [50]. The report references a study of around 14,000 American youths (mean age 14 years) that reported 81.5% of current youth e-cigarette users said they used e-cigarettes because they come in flavors I like [50]. In conclusion, the use of nicotine by children and young people is unsafe, it can cause addiction and can harm the developing adolescent brain - there are no benefits to children and young people in using ENDS. There is concern that ENDS are seen as safe but this is not the case, while the Date: 11/01/17 Version: 1.0 Page: 23 of 49

37 health risks of ENDS are significantly lower than cigarettes they are not without risk. Proposed Position ENDS should feature alongside other health-harming substances e.g. tobacco and alcohol, in all health education for children and young people, and be presented as harmful to health. A systematic enforcement programme should be developed to minimise the sales of ENDS to those less than 18 years of age, including development of a register of retailers and systematic testpurchasing, prosecution and media activity. Confectionary-like flavours of e-liquid should not be permitted, in order to reduce the appeal of ENDS to children and young people. There should be restrictions on the use of ENDS in settings predominantly used by children e.g. in schools and school grounds and around the entrances to schools. There should be restrictions on the advertising of ENDS in all media that would be regularly viewed by children and young people Non-smoking general population Earlier work had suggested that the risk to non-smokers of passive exposure to second hand aerosols from vaping was negligible. However, more recent research has indicated that this may not be the case. There is relatively little conclusive evidence on the risks associated with second-hand aerosols (SHA) relative to second hand smoke or ambient air, but the WHO conclusion is that SHA is likely to pose an increased risk for the health of all bystanders [3]. The WHO report notes that levels of nickel and chromium are higher in SHA from ENDS than in second hand smoke and certainly background air, but the magnitude of the associated risks to health are unknown. The US Surgeon General s report [50] notes that E-cigarettes represent another [in addition to cigarette smoke] potential source of exposure to toxicants for nonusers, via second-hand or third-hand exposure to aerosol., whilst acknowledging the concentration of the e-liquid, strength of the heating device, and method of use are amongst factors that determine the level of exposure. Concern has been expressed on the potential impact of e-cigarette use on enforcement of the restrictions on smoking in public spaces or in vehicles carrying children. Research evidence in this area was not identified. In conclusion, there is some evidence of the potential for ENDS use to have a negative impact on indoor air quality and represent a risk to health. Currently, the available evidence is inconclusive on the risk. Voluntary Date: 11/01/17 Version: 1.0 Page: 24 of 49

38 restrictions on the use of ENDS in many public spaces are already in place. Further work should be undertaken by Public Health Wales Environmental Public Health Team to make a more detailed risk assessment based on the available evidence. Proposed Position Until a more definitive risk assessment can be completed, voluntary restrictions on the use of ENDS in enclosed public spaces should continue Smokers that are ready to quit now ENDS are becoming increasingly cited as a chosen method to help smokers to quit, particularly those who do so without any advice or help. The vast majority of smokers that are motivated to quit currently attempt to quit without specialist support, and this includes via using ENDS. This relatively new, consumer-driven product presents another option for motivated smokers to initiate and pursue a quit attempt. A Cochrane systematic review published in September 2016 found evidence from two trials that ENDS were more likely to help smokers to quit in the long term, than placebo ENDS. However, the small number of trials, low event rates and wide confidence intervals around the estimates mean that confidence in the results is rated 'low' [48]. When compared with existing pharmacological aids to stopping smoking the evidence currently for the benefit of e-cigarettes is limited. The Royal College of Physicians [1] note that ENDS are not currently made to medicines standards and are probably more hazardous than nicotine replacement therapy. The introduction of the tobacco products directive may have an impact on product safety, and mitigate some of these concerns, once fully implemented. In conclusion, NHS stop smoking services which provide behavioural support and access to licensed pharmacotherapy currently offer the greatest likelihood of stopping smoking. However, the majority of smokers who make a quit attempt do so without specialist support. For these smokers, ENDS may prove helpful in achieving a successful quit from tobacco although they are not currently licensed as a medicine for this purpose. Proposed Position If you smoke and would like to stop there are a range of medicines and other help available from NHS Wales. Research shows that if you get help to quit you are four times more likely to stop. If you prefer Date: 11/01/17 Version: 1.0 Page: 25 of 49

39 to go it alone then e-cigarettes may be helpful in your quit attempt, although they are not currently licensed as a medicine for this purpose. Independent and unbiased advice on different aids to quitting smoking is available from Stop Smoking Wales. Public Health Wales will include information on ENDS alongside other aids to stopping smoking in all information materials and in Stop Smoking Wales support services. Information on all products will be presented to support smokers in making an informed choice about the best way to quit for them. The use of ENDS by pregnant women is not recommended. Health and care professionals giving smoking cessation advice should be able to describe the relative quit rates of, and likelihood of success from, using different smoking cessation methods, including ENDS; to help smokers make an informed choice about the best route to quitting smoking for them Committed smokers who are unwilling or unable to quit ENDS are capable of providing the nicotine that smokers are addicted to without many of the other harmful components of tobacco smoke, and so can prevent most of the harm from smoking.[1] The Public Health England Report [10] included a current expert estimate that using EC [ENDS] is around 95% safer than smoking. Although quantifying the difference in this way has recently been challenged by the WHO, they are clear that ENDS are less toxic than tobacco smoke [3]. The benefits of switching to ENDS, and away from tobacco, for this cohort are undeniable. ENDS are unlikely to be harmless but WHO notes the number and level of known toxicants generated [by using] ENDS is on average lower or much lower than in cigarette smoke, so for this cohort, relative to continuing to smoke, the harms are not significant [3]. There may be some (as yet unknown) harms from long-term use, but it appears unlikely these would outweigh the long-terms harms from tobacco use, so from this perspective again on balance the harms for this cohort of smokers are essentially not significant. In conclusion, for committed smokers who are unwilling or unable to quit there is a high degree of consensus that the benefits of using ENDS significantly outweigh the harms. The harms associated with the alternative, of continuing to use tobacco, are significant and well Date: 11/01/17 Version: 1.0 Page: 26 of 49

40 established. The exception to this advice would be for pregnant women, as the potential risks to the unborn child are unknown. Proposed Position If you are a smoker who is unwilling or unable to stop smoking now, switching completely from smoking tobacco to using e-cigarettes will significantly reduce the risks to your health. This advice does not apply to pregnant women who should consider using licensed nicotine replacement products. Health care workers working with those smokers who are unwilling or unable to quit now should advocate a complete switch to using e- cigarettes, as this will significantly reduce the risks to their patients health. This advice does not apply to pregnant women who should be encouraged to switch to licensed nicotine replacement products. Date: 11/01/17 Version: 1.0 Page: 27 of 49

41 APPENDIX A Public Health Wales Position Statement 11 December 2013 E Cigarettes or electronic nicotine delivery systems (ENDS). This position statement represents the views of Public Health Wales based on the best available evidence at the time or writing. It does not represent Welsh Government Policy. It has been produced to enable Public Health Wales employees to provide consistent professional advice to the public, our partners and our service users. Please check to see if a more recent version of this advice is available. What are e-cigarettes? Electronic cigarettes, e-cigs or ENDS (electronic nicotine delivery systems) are devices whose function is to vaporize and deliver to the lungs of the user a chemical mixture typically composed of nicotine, propylene glycol and other chemicals, although some products claim to contain no nicotine. A number of ENDS are offered in flavours that can be particularly attractive to adolescents. Electronic cigarettes (e-cigs) are the most common prototype of ENDS. (1) Most ENDS are shaped to look like their conventional (tobacco) counterparts (e.g. cigarettes, cigars, cigarillos, pipes, hookahs or shishas). They are also sometimes made to look like everyday items such as pens and USB memory sticks, for people who wish to use the product without other people noticing (1). Why is there concern about e-cigarettes? There has been a rapid increase in the use, availability and promotion of e-cigs. While there is potential for ENDS to reduce the harm from smoking or help smokers to quit, their effectiveness or safety has not been demonstrated. The current position on regulation of ENDS is unclear. The MHRA had previously announced that the government intended to regulate electronic cigarettes and other nicotine containing products (NCPs) as medicines (2). However, the outcome of the European Parliament vote in October 2013 on a revision to the Tobacco Products Directive (3) did not support this approach to regulation. Public Health Wales, in line with a number of national and international bodies (4) (1) (5) (6) has identified the following potential risks to health and proposes that a precautionary approach is adopted until further information becomes available. Nicotine is a poison, scientific testing indicates that the products vary widely in the amount of nicotine and other chemicals they deliver and Date: 11/01/17 Version: 1.0 Page: 28 of 49

42 there is no way for consumers to find out what is actually delivered by the product they have purchased. Use of e-cigs may reduce the likelihood of smokers quitting by displacing scientifically proven methods to help people quit. ENDS mimic smoking a cigarette and could play a role in normalising smoking behaviour. Considerable strides have been made in denormalising smoking but there is much more to do. Anything which may reverse the progress made to de-normalise smoking would be a risk to population health. The presentation of e-cigs as a safe way to smoke may provide a route to nicotine addiction for children and young people; this may in turn lead to smoking tobacco. Public Health Wales advises that: Smokers who wish to quit or reduce their smoking, should be advised to access one of the free NHS services which provide scientifically proven support including a range of tested nicotine replacement products (Stop Smoking Wales ). The promotion of e-cigs/ends should be strictly limited to smokers only. It should not promote the concept of safe smoking and should only be as a way to cut down and quit. Whether any marketing should be allowed at all requires urgent review Their use should be prohibited in workplaces, educational and public places to ensure their use does not undermine smoking prevention and cessation by reinforcing and normalising smoking. ENDS should not be available to those under 18. Anything that might increase their appeal to children should be avoided e.g. flavouring; packaging. Promotion must not appeal to non-smokers, in particular children and young people. This could include product appearance and packaging being plain in order not to attract people into using it. There should be no flavoured products. Research is needed to increase our understanding of ENDS in particular the safety; effectiveness; role in normalising smoking behaviour and role as a gateway to nicotine addiction and smoking, particularly in children. Date: 11/01/17 Version: 1.0 Page: 29 of 49

43 Background Paper Updated Position Statement on E-Cigarettes 1. World Health Organisation. Tobacco Free Initiative. World Health Organisation. [Online] 9 July [Cited: 8 October 2013.] /en/. 2. Medicines and Healthcare Products Regulatory Agency. Nicotine Containing Products. MHRA. [Online] 31 July [Cited: 8 October 2013.] ce/product-specificinformationandadvice/productspecificinformationandadvice M T/NicotineContainingProducts/index.htm. 3. European Commission. Tobacco - Revision of the tobacco products directive. European Commission. [Online] [Cited: 8 October 2013.] 4. US Food and Drug Administration. Electronic Cigarettes. FDA. [Online] 25 April [Cited: 8 October 2013.] 5. BMA. Tobacco E Cigarettes. BMA. [Online] January [Cited: 8 October 2013.] 6. ASH. ASH Briefing Electronic Cigarettes. ASH. [Online] June [Cited: 8 October 2013.] Date: 11/01/2017 Version: 1.0 Page: 30 of 49

44 Background Paper Updated Position Statement on E-Cigarettes APPENDIX B Chronology of key aspects of the current state Date Product/Output Summary December 2012 (13 th ) June 2015 (30 th ) Public Health Wales Position Statement on ENDS Public Health Wales submission to the Health and Social Care Committee, evidence session on the Public Health (Wales) Bill. ales/documents/s42220/hsc %20paper%202.pdf Appendix A Public Health Wales acknowledged potential role of ENDS in helping those smokers who wish to quit smoking or particularly those who, while not able to quit at the current time, wish to reduce the harm from using tobacco. Highlighted no evidence that the introduction of measures to restrict the use of ENDS in enclosed public places would undermine the potential benefits of harm reduction. Further, no evidence that this would deter people from switching to a less harmful product. Smokers of tobacco currently are unable to smoke when and where they please and are well used to restrictions, if they switch to ENDS then they will still gain in health terms. Noted importance that the focus on e-cigarettes as a potential means to quit smoking does not overshadow other evidence based approaches and that smokers who wish to quit receive accurate information about the quit options. Current evidence suggesting that use of ENDS is broadly in line with the use of nicotine replacement therapy bought over the counter. PHW belief was that the proposals strike the appropriate balance between meeting the needs of smokers who wish to quit and avoidance of potential Date: 11/01/2017 Version: 1.0 Page: 31 of 49

45 Date: 11/01/17 Version: 1.0 Page: 32 of 49 harm through normalisation of smoking behaviour. On normalisation: It was noted that the UK and International Tobacco Control Policy has included a number of core, inter-related approaches. One of the key elements has been efforts to de-normalise smoking as a behaviour. The underpinning rationale of this approach has been twofold: To create an environment in which young children were not routinely exposed to smoking as a normal behaviour of adults To support those smokers who are attempting to quit by providing environments which reduce cues to smoking behaviour or reduce the opportunity to smoke. The widespread use of e-cigarettes in public places is likely to undermine these attempts. Noted that the presentation of e-cigarettes as a safe way to smoke may provide a route to nicotine addiction for children and young people. They may be preferable to smoking tobacco but their use is not something to be encouraged regardless of whether this leads to use of other nicotine products. In addition it is possible that, once established, nicotine addiction could lead to tobacco use. Noted however, it would be some time before reliable evidence is available that either supports or refutes those concerns. There is very little information available on the use of e-cigarettes among young people. Given that the product is still relatively new to the market and the rapid growth in their use has been within the last two to three years, it is almost certainly too soon to draw conclusions. The most recent published information from Wales, the CHETS 2 study1, confirms findings of other studies internationally, that e-cigarette experimentation is widespread but that regular use among previous non

46 July 2015 (9 th ) Directors of Public Health (on behalf of the Local Health Boards) submission to the Health and Social Care Committee, evidence session on the Public Health (Wales) Bill Evidence ales/documents/s42221/hsc %20paper%203.pdf tobacco users is rare. Confirmed by data from WHS 2015, Figure 1 & 2 above. Group supportive of restriction of nicotine inhaling devices in enclosed public and work places, bringing the use of these devices into line with existing provisions on smoking. Noted the concentrations of potentially harmful inhalants in e-cigarette vapour may be lower than that of cigarettes, however, they are still present and can still impact on involuntary bystanders, exposing them to greater than normal levels. Levels also remain higher than found in nicotine inhalers and some brands have been shown to contain levels of cancercausing agents, such as formaldehyde and acrolein, as high as that found in cigarette smoke. Observation that many devices had not been tested by independent scientists but, where testing had taken place, wide variations in toxicity have been found. Noted that there may also be indirect risk from such devices and their refills which are not child protection packaged, if the device/refill is left unattended, dropped or discarded. The Group considered that allowing use of e-cigarettes in places where smoking is banned would undermine and make more difficult enforcement of the smoking ban. The use of these devices is also highly likely to normalise smoking behaviour and undermine the public health progress made so far. The burden of smoking on the NHS in Wales, means it is imperative that clear messages on the unacceptability of smoking on health site grounds are not compromised and made unenforceable. Use of ENDS can both create and maintain nicotine addiction, may act as a gateway for young people, with some evidence of use by young people who have never previously used tobacco. Date: 11/01/17 Version: 1.0 Page: 33 of 49

47 In existing smokers these devices are likely to result in the reduction of cigarette use rather than in quitting, with dual use of e-cigarettes and cigarettes. Group strongly advocated the precautionary principle where there is a sound theoretical argument to support a risk to public health. It is important not to wait for confirmation of harm before taking action. August 2015 (19 th ) E-Cigarettes: an evidence update, Public Health England Report nt/publications/e-cigarettes-anevidence-update 1. Smokers who have tried other methods of quitting without success could be encouraged to try e-cigarettes (EC) to stop smoking and stop smoking services should support smokers using EC to quit by offering them behavioural support. 2. Encouraging smokers who cannot or do not want to stop smoking to switch to EC could help reduce smoking related disease, death and health inequalities. 3. There is no evidence that EC are undermining the long-term decline in cigarette smoking among adults and youth, and may in fact be contributing to it. Despite some experimentation with EC among never smokers, EC are attracting very few people who have never smoked into regular EC use. 4. Recent studies support the Cochrane Review findings that EC can help people to quit smoking and reduce their cigarette consumption. There is also evidence that EC can encourage quitting or cigarette consumption reduction even among those not intending to quit or rejecting other support. More research is needed in this area. Date: 11/01/17 Version: 1.0 Page: 34 of 49

48 November 2015 (16 th ) MHRA granted Nicoventures Trading Limited market authorisation for the medicinal product e-voke 5. When used as intended, EC pose no risk of nicotine poisoning to users, but e-liquids should be in childproof' packaging. The accuracy of nicotine content labelling currently raises no major concerns. 6. There has been an overall shift towards the inaccurate perception of EC being as harmful as cigarettes over the last year in contrast to the current expert estimate that using EC is around 95% safer than smoking. 7. Whilst protecting non-smoking children and ensuring the products on the market are as safe and effective as possible are clearly important goals, new regulations currently planned should also maximise the public health opportunities of EC. 8. Continued vigilance and research in this area are needed. e-voke is (now) a General Sales List (GSL) medicine - so can only be sold by retail, offered or exposed for sale by retail, or supplied in circumstances corresponding to retail sale at registered pharmacies. License covers: Adults aged 18 years and over including pregnant women making a quit attempt. To relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. To aid smokers wishing to quit/reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. The company will be applying to the MHRA for an additional licence for a modified product to allow full-scale commercialisation and automated Date: 11/01/17 Version: 1.0 Page: 35 of 49

49 April 2016 (28 th ) Nicotine without smoke: Tobacco harm reduction Royal College of Physicians Report rojects/outputs/nicotinewithout-smoke-tobacco-harmreduction-0 manufacture and this is likely to take some months. Reminder that smoking is the biggest avoidable cause of death and disability, and social inequality in health, in the UK People smoke because they are addicted to nicotine, but are harmed by other constituents of tobacco smoke. Provision of the nicotine that smokers are addicted to without the harmful components of tobacco smoke can prevent most of the harm from smoking. Until recently, nicotine products have been marketed as medicines to help people to quit. NRT is most effective in helping people to stop smoking when used together with health professional input and support, but much less so when used on its own. E-cigarettes are marketed as consumer products and are proving much more popular than NRT as a substitute and competitor for tobacco cigarettes. E-cigarettes appear to be effective when used by smokers as an aid to quitting smoking. E-cigarettes are not currently made to medicines standards and are probably more hazardous than NRT. However, the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco. Technological developments and improved production standards could reduce the long-term hazard of e-cigarettes. There are concerns that e-cigarettes will increase tobacco smoking by renormalising the act of smoking, acting as a gateway to smoking in young people, and being used for temporary, not permanent, abstinence from smoking. To date, there is no evidence that any of these processes is occurring to any significant degree in the UK. Date: 11/01/17 Version: 1.0 Page: 36 of 49

50 Rather, the available evidence to date indicates that e-cigarettes are being used almost exclusively as safer alternatives to smoked tobacco, by confirmed smokers who are trying to reduce harm to themselves or others from smoking, or to quit smoking completely. There is a need for regulation to reduce direct and indirect adverse effects of e-cigarette use, but this regulation should not be allowed significantly to inhibit the development and use of harm-reduction products by smokers. A regulatory strategy should, therefore, take a balanced approach in seeking to ensure product safety, enable and encourage smokers to use the product instead of tobacco, and detect and prevent effects that counter the overall goals of tobacco control policy. The tobacco industry has become involved in the e-cigarette market and can be expected to try to exploit these products to market tobacco cigarettes, and to undermine wider tobacco control work. However, in the interests of public health it is important to promote the use of e-cigarettes, NRT and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK. April 2016 (21 st ) May 2016 (20 th ) Stop Smoking Wales (Public Health Wales) Practice Note on ENDS use Tobacco and Related Products Regulations Appendix B Require e-cigarette products to be child and tamper proof Ensure the contents of e-cigarette substances are declared on the label and are submitted to regulators prior to sale of the product. Manufacturers will be required to submit data on product sales annually Health warnings about the addictiveness of nicotine must also appear Date: 11/01/17 Version: 1.0 Page: 37 of 49

51 on e-cigarette packaging E-cigarette advertising on television, radio, and in newspapers and magazines will be restricted. Limiting the strength of nicotine in e-cigarette liquid (e-liquid) to 20mg/ml (2%), and the size of e-liquid containers to 10ml, with individual tanks restricted to 2ml Banning additional ingredients such as vitamins, minerals, caffeine and taurine. Manufacturers to set up a system whereby consumers can notify them of suspected adverse events. All products sold must be compliant by 20 May 2017, with the regulations being enforced by local trading standards officers. The Regulations also featured significant restrictions on combustible tobacco. Date: 11/01/17 Version: 1.0 Page: 38 of 49

52 Background Paper Updated Position Statement on E-Cigarettes Appendix C Summary Table of Marketing of E-Cigarettes following implementation of TPD Media type Legislative position Implementing measure Broadcast TV advertising and sponsorship Prohibited Implemented through the BCAP Code and Broadcast Code Broadcast TV product placement Prohibited Communications Act 2003 as amended by the Tobacco and Related Products Regulations 2016 Radio advertising and sponsorship Prohibited Implemented through BCAP Code and the Broadcast Code On-demand television advertising, sponsorship and product placement Newspapers, magazines and periodicals except trade publications and third country publications Internet display advertising, and text message advertising - except trade publications and third country publications Sponsorship of activity/individuals involving or taking place in several Member States or otherwise having cross-border effects Company s own websites, and other non-paid-for online space under their control Prohibited Prohibited Prohibited Prohibited No advertising or promotion but factual information about products, factual how to videos permitted Communications Act 2003 as amended by the Tobacco and Related Products Regulations 2016 Tobacco and Related Products Regulations 2016 Tobacco and Related Products Regulations 2016 UK Tobacco and Related Product Regulations 2016 UK Tobacco and Related Product Regulations 2016 Retailer sites No advertising or promotion but UK Tobacco and Related Product Date: 11/01/2017 Version: 1.0 Page: 39 of 49

53 Blogs/tweets/independently compiled, non paid for reviews E-cigarette trade press and trade to trade communication Cinema, fax, outdoor posters, posters on sides of buses (not travelling outside of the UK), leaflets, and direct hard copy mail factual information about products, factual how to videos and sales lists permitted Permitted Permitted Permitted Regulations 2016 Date: 11/01/17 Version: 1.0 Page: 40 of 49

54 Appendix D Table highlighting types of legislation and regulations enacted, by country USA Mexico New Zealand Scotland Wales England UK Child Safety X Restrictions on sale to children & young people X X 1 Advertising and Marketing Restrictions X 2 X X 3 Import Restrictions X Applied taxation X 4 Health warning labelling X Manufacturing Restrictions X Included within smoke-free restrictions X - non-devolved area; see UK column 1 minimum 18 years old 2 prohibit or restrict the advertising, promotion or sponsorship of e-cigarettes 3 restrictions linked to minimum age of purchase 4 In certain states as of 01/01/2016, taxation present within Minnesota, Kansas, Louisiana, North Carolina and the districts of Montgomery County, Maryland and Chicago and Cook County, Illinois. See [47] for related infographic. Date: 11/01/17 Version: 1.0 Page: 41 of 49

55 Background Paper Updated Position Statement on E-Cigarettes Appendix E Table 1 from Sub national Laws Regulating E- cigarettes Date: 11/01/2017 Version: 1.0 Page: 42 of 49