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BRIEFING PAPER

Number 8114, 31 October 2017

The regulation of e-cigarettes

By Elizabeth Rough Sarah Barber

Contents: 1. Background 2. EU Tobacco Products Directive 3. National Regulations 4. Select Committee Inquiry

2 The regulation of e-cigarettes

Contents Summary 3

The use of e-cigarettes 3 Regulation of e-cigarettes 3 Tobacco Products Directive 3 National regulations 4 Select Committee Inquiry 4

1. Background 5 1.1 What are electronic cigarettes? 5 1.2 Prevalence of e-cigarette use in England and Great Britain 6 1.3 Current e-cigarette users by smoking status 6 1.4 Potential risks and benefits of e-cigarettes 7

Harm reduction 7 Nicotine 9 Gateway and renormalisation concerns 10 Health and safety of the product 12

1.5 Different approaches to e-cigarette regulation 12 A medicine or consumer product? 12 International approaches 13

2. EU Tobacco Products Directive 15 2.1 Overview 15 2.2 The TPD and e-cigarettes 15

Product requirements for e-cigarettes under the TPD and Tobacco Regulations 16 2.3 What is not covered by the TPD? 17 2.4 Support for the Tobacco Products Directive 18 2.5 Opposition to the Tobacco Products Directive 19

Challenge in the House of Lords 20

3. National Regulations 22 3.1 Age restrictions for e-cigarettes 22

England and Wales 22 Scotland 22 Northern Ireland 22

3.2 Use of e-cigarettes in public places 23 3.3 Tobacco Control Plan for England 24 3.4 E-cigarette advertising 25

4. Select Committee Inquiry 26

Cover page image copyright: E-cigarette by Vaping 360. Licenced under CC BY-2.0 / image cropped.

3 Commons Library Briefing, 31 October 2017

Summary The new European Union Tobacco Products Directive (TPD) entered into force on 19 May 2014. It introduced new regulatory controls on electronic cigarettes (e-cigarettes), as well as setting out requirements on tobacco products. The UK Tobacco and Related Products Regulations 2016 implemented the TPD in full. This Commons Library Briefing Paper outlines the new product requirements for e-cigarettes and identifies where national regulations have gone beyond what is in the TPD.

The use of e-cigarettes Unlike conventional cigarettes, e-cigarettes do not contain tobacco, do not involve burning and thus do not produce carbon monoxide, tar or smoke. They work by heating a solution of water, flavouring, propylene glycol, and, typically, nicotine to create a vapour that the user inhales. Using an e-cigarette is often described as ‘vaping’ rather than smoking. It was estimated in 2017 that 2.9 million people aged 18 and over in Great Britain were using e-cigarettes, up from 700,000 in 2012. Survey data indicates that consumers are increasingly turning to e-cigarettes as a means to cut back on smoking tobacco, or to quit tobacco completely.

Debates on the benefits and risks of e-cigarettes, particularly regarding their safety and health implications, are ongoing and will continue as more evidence gradually becomes available. A review of the evidence to date, commissioned by Public Health England, reported in 2015 that “best estimates show that e-cigarettes are 95% less harmful to your health than normal cigarettes” and that there was no current evidence to show that they were renormalising smoking, or increasing the uptake of tobacco cigarettes.

Regulation of e-cigarettes Different approaches to regulating e-cigarettes have been adopted internationally. Prior to the introduction of the Tobacco Products Directive (TPD), the UK initially regulated e-cigarettes as consumer products that were subject to existing product safety regulations. Some countries went further and banned the sale, distribution and importation of e-cigarettes, while others have no regulations in place. An alternative approach, considered by the UK Government, was to regulate all nicotine-containing e-cigarettes as medicines. While the UK Medicines and Healthcare products Regulatory Agency set out plans in 2013 to implement this approach, they were superseded by the introduction of the TPD.

Tobacco Products Directive The European Union Tobacco Products Directive entered into force on 19 May 2014, with the UK Tobacco and Related Products Regulations 2016 implementing the TPD in full across the UK. According to the European Commission, the TPD’s aim is to “improve the functioning of the internal market for tobacco and related products while ensuring a high level of health protection for European citizens”. Article 20 of the TPD introduces new regulatory controls for nicotine-containing e-cigarettes and refill containers, though it does not cover nicotine-containing products that are authorised as medicines. These controls aim to ensure:

• minimum standards for the safety and quality of all e-cigarettes and refill containers;

• that information is provided to consumers so that they can make informed choices;

• an environment that protects children from starting to use these products.

4 The regulation of e-cigarettes

National regulations The TPD does not seek to harmonise rules on:

• smoke-free environments;

• domestic advertising;

• domestic sales;

• age restrictions;

• nicotine–free cigarettes;

• flavourings of e-cigarettes.

These elements can all be regulated at a domestic level. England, Northern Ireland, Scotland and Wales have each introduced age restrictions on e-cigarettes that prohibit their sale to, and their purchase on behalf of, under 18s. In 2015/16 the Welsh Government attempted to go further and introduce controls on the use of e-cigarettes in public places, though the Bill was subsequently rejected by the Welsh Assembly. The Scottish Government has made provision, through the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016, to restrict the advertising of vapour products through secondary legislation, though this is not yet in place.

Select Committee Inquiry On 25 October 2017, the House of Commons Science and Technology Select Committee launched an Inquiry to look at the science behind e-cigarettes and the impact on health, the regulation of the products and financial implications.

The terms of reference of the inquiry have been published and the Committee is accepting written evidence until 8 December 2017.1

1 House of Commons Science and Technology Select Committee, E-cigarettes inquiry (accessed 31 October

2017)

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1. Background

1.1 What are electronic cigarettes? Electronic cigarettes (also known as e-cigarettes, electronic nicotine delivery system (ENDS), or vaporisers) work by heating a solution of water, flavouring, propylene glycol (or vegetable glycerine) and, typically, nicotine to create a vapour that the user inhales. The act of using an e-cigarette is often referred to as ‘vaping’. Devices tend to consist of a mouthpiece, a battery-powered heating element, a cartridge or refillable tank containing the liquid solution and an atomiser that vapourises the solution when heated.

Box 1: The components of an e-cigarette

Source: E-cigarettes: Frequently Asked Questions, Scottish Parliament Information Centre (SPICe), November 2014

Product innovation has been rapid. In 2014, it was estimated that there were over 460 brands of e-cigarette and 7,500 flavours of solution.2 The first generation of e-cigarettes, available from the mid 2000s onwards, tended to look like ‘traditional’ cigarettes and were often disposable. Second generation e-cigarettes, in contrast, were larger and not designed to resemble a cigarette. The Royal College of Physicians (RCP) note that they are “typically the size of a large fountain pen, and incorporate a more powerful battery linked to a permanent vaporiser, and a tank system that users can refill with nicotine solution”.3 More recently, a third generation of e-cigarettes has been developed. These are intended to be customised by the user to suit their preferences. Some, for example, have a more powerful battery, thereby allowing for variable voltage and adjustable air flow to alter the delivery of nicotine. Others may also include downloadable software to monitor usage and consumption via a mobile app.

2 Zhu et al, Four hundred and sixty brands of e-cigarettes and counting: implications

for product regulation. Tobacco Control Vol 23, iii3–iii9. 2014 3 Royal College of Physicians, Nicotine without smoke. Tobacco harm reduction. A

report by the Tobacco Advisory Group of the Royal College of Physicians, 28 April 2016

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1.2 Prevalence of e-cigarette use in England and Great Britain

Figures produced by the Office for National Statistics (ONS) in 2017, based on 2015 data, show that 4.5% of over 16s in England currently use an e-cigarette (2.3 million people), compared to 3.7% in 2014.4 Use varies by age, with 6.5% of 35 to 49 year olds reporting current usage in 2015, compared to 2.6% of people aged 60 and over. Use is also slightly higher in men (4.7%) than women (4.4%). By way of comparison, 16.9% of adults in England smoked tobacco cigarettes in 2015.5 When asked about the main reason for using e-cigarettes, 49% of respondents said that they were an ‘aid to stop smoking’, while 22% stated that they perceived them to be ‘less harmful than cigarettes’.6

Figures for Great Britain have been produced by the ASH Smokefree GB Surveys. ASH – ‘Action on Smoking and Health’ – describes itself as “a campaigning public health charity that works to eliminate the harm caused by tobacco”. ASH estimates that in 2017 there were 2.9 million people aged 18 and over using e-cigarettes (5.8% of the population) compared to 2.6 million in 2015 and 700,000 in 2012. Of the 2.9 million, 1.5 million (52%) were ex-smokers, 1.3 million (45%) continued to use tobacco alongside e-cigarettes and 3% were ‘never smokers’.7

1.3 Current e-cigarette users by smoking status

Source: ASH, Use of e-cigarettes (vapourisers) among adults in Great Britain by smoking status, May 2017

Among current e-cigarette users who are also ex-smokers, the top three reasons for using e-cigarettes in 2017 were:

• To help me stop smoking entirely (61%);

4 Office for National Statistics, Adult smoking habits in the UK: 2015, March 2017 5 Office for National Statistics, Adult smoking habits in the UK: 2015, March 2017 6 Office for National Statistics, Adult smoking habits in the UK: 2015, March 2017 7 ASH, Use of e-cigarettes (vapourisers) among adults in Great Britain, May 2017

7 Commons Library Briefing, 31 October 2017

• To save money compared with smoking (40%);

• To help me keep off tobacco (39%).8

Initial data from the Northern Ireland Health Survey (2015/16) – based on a sample of 3,915 people aged 16 and over – show that 6% of respondents currently use an e-cigarette, while 17% of men, and 16% of women have tried using an e-cigarette.9

1.4 Potential risks and benefits of e-cigarettes

Debates on the risks and benefits of e-cigarettes have tended to focus on:

• the role of e-cigarettes in harm reduction and helping people to reduce, or stop, smoking;

• whether e-cigarettes ‘normalise’ smoking and act as a ‘gateway’ to conventional tobacco products, particularly among children and young people;

• the health and safety of the product.

Definitive answers to these questions are not yet available. The diversity of brands, models, product claims, nicotine strengths, flavours and ingredients, together with variations in use from person to person, have all made assessing the public health impact and safety of e-cigarettes challenging. Furthermore, the rapid development of e-cigarettes, combined with the fact that they are still a fairly novel device (particularly in comparison to tobacco cigarettes), has led to suggestions that conclusive evidence on the risks and benefits may be years, and possibly decades, away.10

Harm reduction Harm reduction refers to policies, programmes and practices that aim to reduce the detrimental effects associated with a behaviour in people unable or unwilling to stop. It has been a controversial issue in tobacco control, where smoking cessation and prevention have long been the focus of public health strategies.11 The Royal College of Physicians reported that “harm reduction, and in particular the role of e-cigarettes, has probably split global and, to some extent, national opinion on tobacco control more than any other issue”.12 The statistics cited in section 1.2, however, highlight that consumers are using e-cigarettes as

8 ASH, Use of e-cigarettes (vapourisers) among adults in Great Britain, May 2017 9 M Scarlett & J Denvir, Health Survey (NI): First Results 2015/16, Public Health

Information & Research Branch, Department of Health (NI) 10 Conference of the Parties to the WHO Framework Convention on Tobacco Control.

Electronic nicotine delivery systems. Report by WHO, September 2014, para 15 11 Z Cahn and M Siegel, Electronic cigarettes as a harm reduction strategy for tobacco

control: a step forward or a repeat of past mistakes? J Public Health Policy, Vol 32 (2011) pp 16-31

12 Royal College of Physicians, Nicotine without smoke. Tobacco harm reduction. A report by the Tobacco Advisory Group of the Royal College of Physicians, 28 April 2016, p3

8 The regulation of e-cigarettes

a means to stop smoking tobacco products and/or to stop smoking entirely.

In the UK, tobacco harm reduction strategies have been pursued alongside smoking cessation services, but with an emphasis on prescribing medicinally licensed products, such as nicotine replacement therapies.13 The National Institute for Health and Care Excellence (NICE) guidelines for tobacco harm reduction, for example, state that:

stop smoking services provide highly cost-effective interventions to help people stop smoking and any investment in the harm-reduction approaches covered by this guidance should not detract from their provision.14

Medicinally licensed e-cigarette products are not yet available in the UK.15 Claims relating to smoking cessation can only be made on products that have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) and have successfully evidenced those claims for that particular product.16

At present, there is a lack of good quality evidence on the efficacy of e-cigarettes as a means to help people quit, or reduce, smoking. The World Health Organization (WHO) reported in 2014 that the “evidence for the effectiveness of ENDS as a method for quitting tobacco smoking is limited and does not allow conclusions to be reached”.17 This briefing does not aim to provide a systematic review of the evidence that has been published to date on the effectiveness of e-cigarettes as a harm reduction tool. An overview, however, can be found in ‘E-cigarettes: an evidence update’, a report commissioned by Public Health England and published in 2015.18

In a summary of its findings, PHE stated that it was “not known whether current [e-cigarette] products are more or less effective than licensed stop-smoking medications” though it added that e-cigarettes were “much more popular, thereby providing an opportunity to expand the number of smokers stopping successfully”.19 The Government’s position has been that “the best thing a smoker can do is to quit and

13 C Rooke, Harm reduction and the medicalisation of tobacco use, Sociology of Health

& Illness, Vol 35 (2012) pp 361–376 14 NICE, 'Recommendations' in Smoking: harm reduction, Public health guideline

[PH45], June 2013; NICE is a Non Departmental Public Body providing national guidance and advice to improve health and social care.

15 The MHRA granted a licence to 'Nicoventures', a company owned by British American Tobacco (BAT), for its ‘e-voke’ 10mg and 15mg electronic inhaler, in November 2015. This authorises the company to market the device as a smoking cessation aid. Reuters, however, reported in January 2017 that BAT had “quit plans to market a nicotine inhaler called Voke to focus on consumer items like e-cigarettes rather than health products” after manufacturing issues delayed the launch of Voke.

16 The MHRA regulates medicines, medical devices and blood components for transfusion in the UK.

17 Conference of the Parties to the WHO Framework Convention on Tobacco Control. Electronic nicotine delivery systems. Report by WHO, September 2014, para 19

18 McNeill A et al, E-cigarettes: an evidence update. A report commissioned by Public Health England, August 2015

19 McNeill A et al, E-cigarettes: an evidence update. A report commissioned by Public Health England, August 2015, p10

9 Commons Library Briefing, 31 October 2017

quit for good” but that for those “that are unable to quit, switching to e-cigarettes is less harmful than continuing to smoke”.20

Nicotine In addition to considering if e-cigarettes can be an effective smoking reduction and cessation aid, attention has also turned to their health implications. Unlike conventional cigarettes, no tobacco or combustion (burning) are involved in e-cigarettes and, as such, they do not produce carbon monoxide, tar, or smoke. The majority of e-cigarettes do contain nicotine – the primary addictive component of tobacco cigarettes. Concerns have been raised about the harms associated with nicotine consumption and whether the amount delivered via e-cigarettes is sufficient to cause health problems.

The prevailing body of evidence indicates that nicotine does present “some risks to health” but that “overall they are relatively minor”.21 The Royal College of Physicians reported that there was “sufficient evidence to conclude that any harm from long-term nicotine use will still be negligible compared with the harm of tobacco use”.22 Similarly, Public Health England has stated that:

Nicotine does not cause serious adverse health effects such as acute cardiac events, coronary heart disease or cerebrovascular disease and is not carcinogenic. The doses of nicotine delivered by electronic cigarettes are therefore extremely unlikely to cause significant short or long-term adverse events.23

The WHO, however, has highlighted that nicotine can have “adverse effects during pregnancy and may contribute to cardiovascular disease”. It also noted that while “nicotine itself is not a carcinogen, it may function as a “tumour promoter” on the grounds that it has been shown to alter “essential biological processes”. These include the formation of new blood vessels, as well as the growth, division and migration of “a wide variety of cells including fetal, embryonic and adult stem cells, adult tissues as well as cancer cells”.24

It went on to state that, for these reasons, “the evidence is sufficient to caution children and adolescents, pregnant women, and women of reproductive age about [electronic nicotine delivery systems] use because of the potential for fetal and adolescent nicotine exposure to have long-term consequences for brain development”. 25

While nicotine delivery from e-cigarettes is variable, an analysis conducted by researchers at the US Food and Drug Administration (FDA) found that:

20 PQ 48248 [on Electronic Cigarettes: Sales], 18 October 2016 21 ASH, Nicotine and addiction, January 2016 22 Royal College of Physicians, Nicotine without smoke. Tobacco harm reduction. A

report by the Tobacco Advisory Group of the Royal College of Physicians, 28 April 2016, p 63

23 J Britton and I Bogdanovica, Electronic cigarettes, A report commissioned by Public Health England, May 2014, p7

24 Conference of the Parties to the WHO Framework Convention on Tobacco Control. Electronic nicotine delivery systems. Report by WHO, September 2014, para 13

25 Conference of the Parties to the WHO Framework Convention on Tobacco Control. Electronic nicotine delivery systems. Report by WHO, September 2014, para 13

10 The regulation of e-cigarettes

Nicotine yields from automated smoking machines suggest that e-cigarettes deliver less nicotine per puff than traditional cigarettes, and clinical studies indicate that e-cigarettes deliver only modest nicotine concentrations to the inexperienced e-cigarette user.26

They cautioned, however, that more experienced e-cigarette users could “achieve systemic nicotine and/or cotinine concentrations similar to those produced from traditional cigarettes”. 27

In addition to harms arising from nicotine, the Royal College of Physicians noted that “some of the carcinogens, oxidants and other toxins present in tobacco smoke have also been detected in e-cigarette vapour”, thereby raising “the possibility that long-term use of e-cigarettes may increase the risks of lung cancer, COPD, cardiovascular and other smoking-related diseases”. It went on to state that “the magnitude of such risks is likely to be substantially lower than those of smoking, and extremely low in absolute terms”.28

A similar point about the magnitude of risk was made in the 2015 evidence review of e-cigarettes commissioned by PHE. It reported that “best estimates show e-cigarettes are 95% less harmful to your health than normal cigarettes” and that “when supported by a smoking cessation service [they] help most smokers to quit tobacco altogether”.29 A joint statement was subsequently published in 2016 by PHE with 12 other health charities and public health bodies. It explained that:

We all agree that e-cigarettes are significantly less harmful than smoking. One in two lifelong smokers dies from their addiction. All the evidence suggests that the health risks posed by e-cigarettes are relatively small by comparison but we must continue to study the long-term effects.30

In response to a written question in March 2017, the Government stated that PHE’s next updated evidence report on e-cigarettes was “expected to be published before the end of the 2017”.31

Gateway and renormalisation concerns PHE’s 2015 evidence review also questioned the idea that e-cigarettes act as a ‘gateway’ to traditional tobacco consumption among young people and non-smokers, stating that:

Cigarette smoking among youth and adults has continued to decline and there is no current evidence in England that [e-cigarettes] are renormalising smoking or increasing smoking uptake. Instead, the evidence reviewed in this report point in the

26 M Schroeder and A Hoffman, Electronic cigarettes and nicotine clinical

pharmacology, Tobacco Control Vol 23, (2014) pp ii30–ii35. 27 M Schroeder and A Hoffman, Electronic cigarettes and nicotine clinical

pharmacology, Tobacco Control Vol 23, (2014) pp ii30–ii35. 28 Royal College of Physicians, Nicotine without smoke. Tobacco harm reduction. A

report by the Tobacco Advisory Group of the Royal College of Physicians, 28 April 2016, p87

29 McNeill A et al, E-cigarettes: an evidence update. A report commissioned by Public Health England, August 2015, p5

30 Public Health England, E-cigarettes: a developing public health consensus. Joint statement on e-cigarettes by Public Health England and other UK public health organisations, July 2016.

31 PQ 67483 [on Electronic Cigarettes], 21 March 2017

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direction of an association between greater uptake of [e-cigarettes] and reduced smoking.32

A different picture was presented by the former US Surgeon General, Vivek H. Murthy, in his 2016 report on ‘E-Cigarettes Use Among Youth and Young Adults’ in the United States. According to the report, e-cigarette use has grown “900% among [US] high school students [between] 2011 [and] 2015”, to the point where they have become “the most commonly used tobacco product among youth in the United States”, surpassing “cigarettes, cigars, chewing tobacco, and hookahs”.33 The report also stated that e-cigarette use “among youth and young adults is associated with the use of other tobacco products, including conventional cigarettes”.34

PHE has previously questioned the reporting of similar findings, stating that most of the increase in use of e-cigarettes by young people in the United States “occurred as a result of use by people who already use some form of tobacco product”.35 In the UK, ONS data from 2014 showed that over a fifth (22%) of secondary school pupils (mostly aged 11-15) had used e-cigarettes at least once. This included most pupils who smoked cigarettes regularly (89%). E-cigarette use was lower among pupils who had never smoked (11%).36

More recently, a study reported that “surveys across the UK show a consistent pattern: most e-cigarette experimentation does not turn into regular use” adding that “regular use among 11–16 year olds remains very low, at 3% or less, and remains largely confined to regular smokers”. The study drew on five, large-scale surveys, conducted between 2015 and 2017 which, cumulatively, collected data from over 60,000 young people aged 11-16.37

A separate study, also published in 2017, stated that it was the first to report a “prospective relationships between ever use of e-cigarettes and initiation and escalation of cigarette use among UK adolescents”. It relied on data from 2836 people aged 13–14 years in 20 schools in England. The study authors, however, urged caution when interpreting the results. They noted that while:

a causal relationship may be plausible, we cannot confirm this based on our findings and the trends observed over the same time

32 McNeill A et al, E-cigarettes: an evidence update. A report commissioned by Public

Health England, August 2015, p 7 33 US Department of Health and Human Services, E-Cigarette Use Among Youth and

Young Adults. A Report of the Surgeon General, December 2016, p vii 34 US Department of Health and Human Services, E-Cigarette Use Among Youth and

Young Adults. A Report of the Surgeon General, December 2016, p v 35 J Britton and I Bogdanovica, Electronic cigarettes, A report commissioned by Public

Health England, May 2014, p8 36 Office for National Statistics, Smoking, Drinking and Drug Use Among Young People

in England - 2014, July 2015 37 A Bauld et al, Young People’s Use of E-Cigarettes across the United Kingdom:

Findings from Five Surveys 2015–2017, International Journal of Environmental Research and Public Health, 2017, 14, 973.

12 The regulation of e-cigarettes

period in the UK; rates of e-cigarette use have increased, but the rates of cigarette use have continued to decline.38

Health and safety of the product Other concerns associated with e-cigarettes have been linked to the quality and safety of the product, such as fires, battery explosions and the ingestion of the e-liquid/poisonings. The Royal Society for the Prevention of Accidents notes that “poorly made or counterfeit chargers for e-cigarettes have caused house fires” and therefore encourages users to “only buy e-cigarettes from reputable outlets, use the correct charger for the device, follow the manufacturer's instructions and don't leave an e-cigarette charging unattended or overnight”.39 PHE concluded that there was “a risk of fire from the electrical elements of [e-cigarettes] and a risk of poisoning from ingestion of e-liquids” and that these “risks appear to be comparable to similar electrical goods and potentially poisonous household substances”.40

1.5 Different approaches to e-cigarette regulation

A medicine or consumer product? The UK’s approach towards regulating e-cigarettes has evolved in recent years. E-cigarettes were initially regulated as consumer products and were subject to existing product safety legislation, enforced by Trading Standards. This covered matters such as the manufacture, marketing, labelling and sale of products, as well as the electrical safety of batteries and chargers. Industry bodies have supported the consumer product approach on the grounds that e-cigarettes are neither tobacco products nor medicinal products intended to cure nicotine addiction and should not, therefore, be regulated as such.41

In June 2013, the UK Government decided that “all nicotine-containing products (NCPs), such as electronic cigarettes” were to be “regulated as medicines in a move to make these products safer and more effective to reduce the harms of smoking”.42 This followed research commissioned by the Medicines and Healthcare products Regulatory Agency (MHRA) into the quality, safety, marketing, and use of the products as well as an impact analysis on the consequences of regulation. It found that “the quality of NCPs can vary considerably”43, with levels of nicotine differing “from what was listed on the label and from batch to batch” and that they “were often poorly manufactured, containing contaminants and

38 M Conner et al, Do electronic cigarettes increase cigarette smoking in UK

adolescents? Evidence from a 12-month prospective study. Tobacco Control Published Online First: 17 August 2017.

39 https://www.rospa.com/home-safety/advice/product/vaping/ 40 McNeill A et al, E-cigarettes: an evidence update. A report commissioned by Public

Health England, August 2015, p 84 41 Electronic Cigarette Industry Trade Association, Response to Welsh Public Health

White Paper, June 2014 42 MHRA, Press release: UK moves towards safe and effective electronic cigarettes and

other nicotine-containing products, 12 June 2013 43 MHRA, Press release: UK moves towards safe and effective electronic cigarettes and

other nicotine-containing products, 12 June 2013

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with leaks of nicotine from the cartridges”.44 The MHRA concluded that “licensing [NCPs] as medicines [would] allow people to have the confidence that they are safe, are of the right quality and work”.45

A similar approach was initially proposed by the European Council in a revision of the 2001 Tobacco Products Directive (Directive 2001/37/EC). Noting that Member States had “so far taken different regulatory approaches to address these products”, the Council proposed in 2012 that:

Nicotine containing products that either have a nicotine level exceeding 2 mg, a nicotine concentration exceeding 4 mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance.46

This was subsequently revised in 2013 when the European Commission proposed a more restrictive change whereby all e-cigarettes would have been subject to pharmaceutical regulation, regardless of their nicotine content; an approach later rejected by the European Parliament.47 The final version of the Tobacco Products Directive ((2014/40/EU) discussed in detail below) allows e-cigarettes to be marketed without a medicines licence if the nicotine concentration does not exceed 20mg/ml. This superseded the MHRA’s 2013 plans to regulate all e-cigarettes as medicines.

International approaches Regulation of e-cigarettes varies internationally. Some countries, including Brazil and Singapore, have adopted neither a medicine nor consumer product approach, instead issuing an outright ban on the sale, distribution and importation of e-cigarettes.48 In Australia, e-cigarette devices are legal but the sale and possession of the nicotine used in them is illegal.49 Other countries, including Malta, regulate e-cigarettes as tobacco products, meaning that they cannot be advertised, they cannot be used in enclosed public spaces, and they can only be used by adults over the age of 18.50 In 2015, however, the WHO

44 I Torjesen, E-cigarettes are to be regulated as medicines from 2016, BMJ

2013;346:f3859 45 MHRA, Press release: UK moves towards safe and effective electronic cigarettes and

other nicotine-containing products, 12 June 2013 46 European Commission, Proposal for a Directive Of The European Parliament And Of

The Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, December 2012

47 D Saitta et al, Achieving appropriate regulations for electronic cigarettes, Therapeutic Advances in Chronic Disease, (2014) Vol 5, pp50-61

48 World Health Organization, WHO Report on the Global Tobacco Epidemic, Country Profile: Brazil, 2015; World Health Organization, WHO Report on the Global Tobacco Epidemic, Country Profile: Singapore, 2015

49 'Ban on nicotine e-cigarettes to remain', SBS, 2 February 2017 50 R D Kennedy et al, Global approaches to regulating electronic cigarettes, Tobacco

Control, November 2017, 26 440-445

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reported that the majority of countries (over 90%) had no national legislation regulating e-cigarettes 51

51 World Health Organization, Report on the Global Tobacco Epidemic. Raising taxes

on tobacco, 2015

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2. EU Tobacco Products Directive

2.1 Overview The European Union Tobacco Products Directive (TPD) (2014/40/EU) entered into force on 19 May 2014. The TPD repeals and replaces Directive 2001/37/EC which did not cover e-cigarettes. Article 20 of the new regulations, however, sets out the requirements for e-cigarettes and refill containers for the first time. The UK Tobacco and Related Products Regulations 2016 (“the Tobacco Regulations”) implemented the TPD in the UK in full and came into force on 20 May 2016.52. Although the Tobacco Regulations apply throughout the UK, devolved nations may choose to apply greater restrictions and, in some instances, have done so. National regulations are discussed below (see section 3).

The Tobacco Regulations set out new requirements and administrative provisions on the manufacture, presentation and sale of tobacco and related products, including e-cigarettes. The European Commission explain that the aim of the TPD is to “improve the functioning of the internal market for tobacco and related products, while ensuring a high level of health protection for European citizens”.53 Key changes include:

• introducing larger and mandatory pictorial health warnings covering 65% of cigarette packaging;

• a ban on “characterising flavours”, such as menthol and vanilla, that conceal the smell and taste of tobacco;

• the introduction of EU-wide tracking and tracing from 2019 to combat the trade of illicit tobacco products and;

• a ban on selling cigarettes in packs of less than 20.

The Tobacco Regulations apply to all tobacco products manufactured from 20 May 2016; however under transitional arrangements, the UK and other Member States allowed manufacturers an additional 12 months to sell old stock. From 20 May 2017, however, all tobacco and related products covered by the Directive must be fully compliant.54

2.2 The TPD and e-cigarettes Article 20 of the TPD introduces new regulatory controls for nicotine-containing electronic cigarettes and refill containers. The TPD does not cover nicotine-containing products that are authorised as medicines. In its guidance on the TPD and e-cigarettes, the Government stated that the Tobacco Regulations aim to ensure:

52 The subject matter of the legislation is largely reserved and concerns harmonising of

trade. The Department of Health, therefore, has agreed to transpose the TPD on behalf of the Devolved Administrations in Scotland, Wales and Northern Ireland.

53 European Commission, Revision of the Tobacco Products Directive, May 2016 54 An additional transitional period does exist for some products. For example, the

prohibition of menthol flavour in cigarettes comes into effect on 20th May 2020.

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• minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids);

• that information is provided to consumers so that they can make informed choices;

• an environment that protects children from starting to use these products.55

Product requirements for e-cigarettes under the TPD and Tobacco Regulations The new requirements for e-cigarettes set out in the TPD, and implemented in the UK by the Tobacco Regulations, cover product standards and nicotine strength; safety; labelling and packaging, notification and vigilance; advertising and annual reporting. These are set out below:

a) Product standards and nicotine strength

• e-cigarette tanks are limited to a capacity of no more than 2ml;

• the maximum volume of e-liquid for sale in one refill container is restricted to 10ml;

• e-liquids are limited to a nicotine strength of no more than 20mg/ml;

• certain ingredients/additives including colourings, caffeine and taurine are banned;

• nicotine doses should be delivered by e-cigarettes at consistent levels under normal conditions of use.

b) Safety

• e-cigarettes and refill products must be:

─ child-resistant and tamper evident;

─ protected against breakage and leakage;

• e-cigarettes and refill products must have a mechanism that ensures refilling without leakage (unless it is a disposable e-cigarette);

• standards for ensuring refilling without leakage are set out in section 36 (10) of the Tobacco and Related Products Regulations 2016.

c) Labelling and packaging

• new labelling and warning requirements include:

─ stating all substances contained in the product, and information on the product’s nicotine strength, on the label;

─ displaying instructions for use, information on addictiveness, and toxicity on the packaging and accompanying information leaflet. This should include a reference that the product is not recommended for use by young people and

55 Medicines and Healthcare products Regulatory Agency, E-cigarettes: regulations for

consumer products, 29 February 2016

17 Commons Library Briefing, 31 October 2017

non-smokers, as well as warnings for specific risk groups and possible adverse effects;

─ a health warning covering 30% of the surfaces of the unit packet and any outside packaging stating “This product contains nicotine which is a highly addictive substance.”

d) Notification and vigilance

• all e-cigarettes and e-liquids are required to be notified to MHRA before they can be sold. Producers of new, or substantially modified, e-cigarette and refill container products must submit a notification to the MHRA six months before they intend to put their product on the UK market;

• a producer of electronic cigarettes or refill containers must establish and maintain a system for collecting information about all of the suspected adverse effects on human health of the product.

e) Advertising

• advertising or promotion (directly or indirectly) of e-cigarettes and refill containers in print media, on the radio and television is prohibited;

• promotional elements are not allowed on e-cigarette packaging and cross-border advertising and promotion of e-cigarettes is prohibited.

f) Annual reporting requirements

• Manufacturers and importers of electronic cigarettes and refill containers will have to submit, annually, to the Secretary of State:

─ comprehensive data on sales volumes, by brand name and type of the product;

─ information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users;

─ the mode of sale of the products; and

─ executive summaries of any market surveys carried out in respect of the above. 56

2.3 What is not covered by the TPD? The TPD does not harmonise rules on:

• smoke-free environments;

• domestic advertising (the situation on advertising is complex, however, and is discussed in further detail in section 3.4);

• domestic sales arrangements;

• age limits for electronic cigarettes or refill containers;

56 Medicines and Healthcare products Regulatory Agency, E-cigarettes: regulations for

consumer products, 29 February 2016 ; ASH, Countdown to 20th May 2016: Changes to tobacco regulations, May 2016; ASH, The impact of the EU Tobacco Products Directive on e-cigarette regulation in the UK, April 2016; Council Directive 2014/40/EU, OJ L 127, 3 April 2014

18 The regulation of e-cigarettes

• nicotine-free e-cigarettes;

• flavourings of e-cigarettes.

Instead, Member States are free to regulate such matters within the remit of their own jurisdiction and are encouraged to do so in the Directive.57 The Government indicated that it was not seeking to go above and beyond what was already in the TPD.58 For example, in October 2016 the Government stated that it had “no further plans to ban or restrict the sale of flavoured e-cigarettes in England”59 and similarly that it had “no current plans to extend smoke-free legislation to e-cigarettes or smokeless tobacco products”.60 Totally Wicked, a supplier of e-cigarettes and e-liquid, commented in January 2016 that “the UK often gold plate EU legislation, but with this one [the TPD], they seem to be bending over backwards not to”.61

2.4 Support for the Tobacco Products Directive

Health organisations and professionals have broadly supported the TPD. Commenting after the text of the TPD was agreed in December 2013, ASH described it as a:

a tremendously important day for public health. ASH congratulates all those who have worked so hard to ensure the Directive stayed on track to get the best possible health outcomes. This is a triumph of public health over the vested interests of the tobacco industry which tried but failed to derail the Directive.62

The Royal College of Nursing stated that it supported “the final text of the Tobacco Products Directive” and called on “the UK Government to transpose the legislation into national law as soon as possible”63, while Cancer Research UK emphasised that the TPD would set “standards on tobacco which will bring real benefits for people's health in the UK and across Europe”.64

Some health organisations wanted the TPD to go further. The Government's response to its consultation on the implementation of the revised Tobacco Products Directive highlighted that:

Many health respondents were encouraging of further, tougher action on tobacco products – urging for more stringent

57 Council Directive 2014/40/EU, OJ L 127, 3 April 2014 58 Department of Health et al, Government response to the consultation on

implementation of the revised Tobacco Products Directive (2014/40/EU), January 2016

59 PQ 48248 [on Electronic Cigarettes: Sales], 18 October 2016 60 PQ 48250 [on Electronic Cigarettes], 18 October 2016 61 'The TPD Consultation and room to wriggle', Vaped by Totally Wicked, 20 January

2016 62 ASH, EU Tobacco Products Directive: agreement reached, 18 December 2013 63 Royal College of Nursing, Tobacco Products Directive (2014/40/EU) RCN Briefing,

May 2014 64 ‘Tough EU smoking rules approved’, BBC News Online, 26 February 2014

19 Commons Library Briefing, 31 October 2017

legislation, recouping of costs from the industry and bringing in legislation as soon as possible.65

2.5 Opposition to the Tobacco Products Directive

There has been a number of legal challenges to the EU Tobacco Products Directive. Of particular relevance to this briefing is a case brought by Pillbox 38 (UK) Limited (which trades under the name ‘Totally Wicked’) relating to the new rules on electronic cigarettes contained in Article 20 of the Directive. The case was initially heard by the High Court of Justice (England and Wales) before being referred to the Court of Justice of the European Union (CJEU) for a preliminary ruling.66 Totally Wicked explained that its challenge was based on its view that:

Article 20 of the TPD represents a disproportionate impediment to the free movement of goods and the free provision of services, places electronic cigarettes at an unjustified competitive disadvantage to tobacco products, fails to comply with the general EU principle of equality, and breaches the fundamental rights of electronic cigarette manufacturers.67

It added that the Directive sought to bring:

e-cigarettes and e-liquid within its [the TPDs] regulatory scope as “tobacco related products” – despite not containing tobacco – and subject e-cigarettes to more stringent regulation than some conventional tobacco products.68

Cases were also brought by Philip Morris International (PMI) and British American Tobacco (BAT), and by the Republic of Poland. PMI and BAT questioned whether a number of provisions in the TPD – including the standardisation of the labelling and packaging of tobacco products – were valid, while Poland opposed the prohibition of menthol cigarettes.69

The Opinion of the Advocate General, Juliane Kokott, was delivered in December 2015 and addressed all of the TPD cases. She concluded that the new EU Tobacco Directive was lawfully adopted. In relation to e-cigarettes, Advocate General Kokott stated that the rules in Article 20 “differ appreciably in several respects from the rules for conventional tobacco products”, were “relatively moderate, both in comparison with the rules for conventional tobacco products and by international

65 Department of Health et al, Government response to the consultation on

implementation of the revised Tobacco Products Directive (2014/40/EU), January 2016, p15

66 A national court can ask the CJEU for ‘preliminary rulings’ when it is in doubt about the interpretation or validity of an EU law and is seeking clarification. Case-law of the Court of Justice of the European Union, Case C‑477/14 Pillbox 38 (UK) Ltd, 4 May 2016

67 ‘European Court rules in totally wicked legal challenge to Article 20 of the Tobacco Products Directive’, Vaped by Totally Wicked, 4 May 2016

68 ‘European Court rules in totally wicked legal challenge to Article 20 of the Tobacco Products Directive’, Vaped by Totally Wicked, 4 May 2016

69 Case-law of the Court of Justice of the European Union, C-547/14 - Philip Morris Brands and Others, 4 May 2016; Case-law of the Court of Justice of the European Union, Case C‑358/14 Republic of Poland, 4 May 2016

20 The regulation of e-cigarettes

standards” and were “ultimately not disproportionate”.70 Though an Advocate General’s Opinion is not binding, the CJEUs final judgment, delivered on 4 May 2016, concurred with the Opinion. The Directive as a whole was judged to be lawful by the Court, including the provisions in Article 20.71

Challenge in the House of Lords Six days after the CJEU’s judgement, the House of Lords debated in Grand Committee a ‘motion to take note’ of the Tobacco and Related Products Regulations 2016, moved by Viscount Ridley. He stressed from the outset that he had “no problem with most of the regulations—just the parts relating to e-cigarettes and vaping”.72 Viscount Ridley described vaping as “a public health triumph that the Department of Health [had], to its extreme shame, done its utmost to block”. He went on to encourage the Government to “have a quick rethink and try to alter the implementation of the directive”, adding that there was a “statutory instrument before us, about a third of which is devoted to stifling an exciting innovation that is saving lives”.73 The focus on e-cigarettes, rather than other aspects of the Regulations, continued throughout the debate.74

Responding for the Government, Lord Prior, then the Parliamentary Under-Secretary of State in the Department of Health, emphasised that the Government was “in favour of [vaping] as a means for people to come off smoking cigarettes” and that the question, therefore, was not about “whether we are in favour of vaping or not” but rather was “about what kind of regulation should be around it”. Lord Prior subsequently clarified that:

The intention of the regulations is to make vaping safer and less variable than it currently is. The intention of the directive is to make it a better product and to cause more people to use it. If it does indeed result in smokers not giving up smoking, then it will have achieved the reverse of what the Government wish to do. The Government’s view is clear: we wish people to quit altogether but if, as a way of quitting, they can give up smoking and take up vaping, that is something that we wish to encourage.75

Following the debate, on 19 May 2016, Lord Callanan moved a prayer motion to annul the Regulations on the grounds that some of the proposed restrictions on e-cigarettes ran counter to advice from the Royal College of Physicians and could “force vapers back to smoking”.76

70 Court of Justice of the European Union, PRESS RELEASE No 154/15: “Advocate

General Kokott considers the new EU tobacco directive of 2014 to be valid”, 23 December 2015; Opinion Of Advocate General Kokott delivered on 23 December 2015, Case C‑477/14 Pillbox 38 (UK) Limited v The Secretary of State for Health

71 Case-law of the Court of Justice of the European Union, Union, Case C‑477/14 Pillbox 38 (UK) Ltd, 4 May 2016

72 HL Deb, 10 May 2016 c61GC 73 HL Deb, 10 May 2016, c64GC 74 HL Deb, 10 May 2016 75 HL Deb, 10 May 2016 c77GC 76 House of Lords Business, Motions relating to Delegated Legislation, Lord Callanan,

19 May 2016

21 Commons Library Briefing, 31 October 2017

Reflecting on what led him to table a prayer for annulment, Lord Callanan explained that:

Everyone who spoke in [Viscount Ridley’s] debate—including, to his enormous credit, the Minister—expressed considerable concern about these regulations. Since it was self-evident that neither the Government nor the Opposition thought this was a helpful package of measures, I put down a Motion for a Prayer for annulment. No one likes these rules, so why implement them?77

He added that he “quickly realised” that he “was straying into controversial constitutional territory” 78; unless it was withdrawn, there would be a debate and a vote on the motion. If agreed to, the statutory instrument implementing the TPD would have fallen. On the 8th June 2016, however, Lord Callanan amended his motion to one of regret, rather than annulment.79

A debate followed on 4 July 2016. Responding for the Government, Lord Prior reiterated his earlier point that there was “no doubt that vaping is far better for you than smoking”. He went on to make three further points. First that restrictions on advertising e-cigarettes formed part of “a precautionary approach to managing any risk that e-cigarettes renormalise smoking behaviours”. Second, that the “regulations provide minimum product standards and reporting of ingredients and emissions” which, in turn, “should reassure smokers who are looking to quit that e-cigarettes are safe and high quality”. Third, that the “UK’s approach to the regulation of e-cigarettes has, and will remain, pragmatic and evidence-based”. After over 90 minutes of discussion, the motion was subsequently withdrawn by Lord Callanan.80

In the House of Commons, Anne Main MP applied to the Speaker on 8 June 2016 for an emergency debate on the Tobacco and Related Products Regulations on the grounds that:

The tobacco regulations will have a huge impact on the vaping and harm-reduction products industry if these regulations pass beyond their praying date of 15 June, yet the House will not have had an opportunity to debate this important matter.81

The Speaker stated that he had “listened carefully to the hon. Lady’s application” but that he was “not persuaded that this matter is proper to be discussed under Standing Order No. 24” and an emergency debate was not held in the Commons. 82

77 HL Deb, 4 July 2016, c1807 78 HL Deb, 4 July 2016, c1807 79 House of Lords Business, Motions relating to Delegated Legislation, Lord Callanan, 8

June 2016 80 HL Deb, 4 July 2016, c1831 81 HC Deb 8 June 2016 c1205 82 HC Deb 8 June 2016 c1206

22 The regulation of e-cigarettes

3. National Regulations In addition to the provisions introduced by the UK Tobacco and Related Products Regulations 2016, the devolved nations have taken steps to address the sale of e-cigarettes to under 18s. An attempt was also made by the Welsh Government to extend smokefree legislation to nicotine products, while some organisations and businesses have already introduced restrictions about the use of e-cigarettes on their premises.

3.1 Age restrictions for e-cigarettes England and Wales Age restrictions on the purchase of tobacco products have been in place since the early 1930s. Under the Children and Young Persons Act 1933, it was an offence to sell tobacco to a person who appeared to be under the age of 16. The Children and Young Persons (Sale of Tobacco etc.) Order 2007 amended the 1933 Act and increased the minimum age of sale of tobacco from 16 to 18 years. Seven years later, Section 91(1) of the Children and Families Act 2014 also made it an offence for an adult to buy tobacco on behalf of someone under the age of 18 (known as ‘proxy purchasing’).

The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 extended these provisions to apply to nicotine products, like e-cigarettes. Regulation 2 makes the proxy purchasing of nicotine products an offence, while Regulation 3 prohibits the sale of nicotine inhaling products to persons under the age of 18. The Regulations include exemptions, however, for both prescription-only, and authorised, medicinal products and devices that are indicated for the treatment of a person under 18. A statutory review of the regulations is due by 2020.

Scotland Restrictions on e-cigarettes in Scotland were introduced under the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016, which came into force on 1 April 2017. The Act brings Scotland in line with England and Wales by making it an offence to sell “a nicotine vapour product to a person under the age of 18” and to “knowingly [buy or attempt] to buy a nicotine vapour product on behalf of a person under the age of 18”.

Northern Ireland The Health (Miscellaneous Provisions) Act (Northern Ireland) 2016 makes provision for the Department of Health in Northern Ireland to make regulations that would prohibit the sale of nicotine products to those aged under 18 years. It also allows for Article 4A of the Health and Personal Social Services (Northern Ireland) Order 1978 (purchase of tobacco on behalf of persons under 18) to be amended so that it applies (with or without modifications) in relation to nicotine products.

23 Commons Library Briefing, 31 October 2017

3.2 Use of e-cigarettes in public places There is currently no national legislation restricting the use of e-cigarettes in public places. Smoke-free legislation, introduced under the Health Act 2006 and enacted through a series of regulations across the devolved nations83, prohibits smoking in enclosed public places and workplaces, on public transport, and in vehicles used for work. Further details can be found in the House of Commons Library Briefing Paper on ‘Smoking in public places’. Under Section 1(2)(a) of the Health Act 2006 “smoking” refers to “smoking tobacco or anything which contains tobacco, or smoking any other substance”. E-cigarettes do not burn tobacco and do not produce smoke. The use of e-cigarettes therefore falls outside of the scope of current smoke-free legislation.

Attempts to introduce controls on the use of e-cigarettes in public places were made by the Welsh Government in 2015/16. Part 2 of the Public Health (Wales) Bill proposed restricting the use of nicotine inhaling devices in enclosed and substantially enclosed public and work places, thereby bringing the use of these devices in line with existing provisions on smoking. The Bill was ultimately rejected: a vote by the Assembly to pass the final text of the Bill in March 2016 was tied at 26-26. The Presiding Officer then exercised her casting vote and voted against the motion.84 A new Public Health (Wales) Bill 2016 was introduced in November 2016, though earlier proposals to restrict the use of e-cigarettes in public places were not included.

Employers can choose whether or not to allow employees to use e-cigarettes at work.85 Some organisations – including councils, hospitals and schools – and businesses – such as train companies and restaurants – have also prohibited the use of e-cigarettes on their premises.

Guidance on developing policies on the use of e-cigarettes in public places and workplaces has been produced by both ASH and PHE. PHE aimed to make its guide “non-prescriptive” on the grounds that “no one-size-fits-all answer exists to the issue of e-cigarette use in public places and workplaces” and instead sets out 5 key principles to consider:

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 86

83 These include Smoke Free Premises etc. (Wales) Regulations 2007, Prohibition of

Smoking in Certain Premises (Scotland) Regulations 2006 and The Smoking (Northern Ireland) Order 2006.

84 Welsh Assembly, Stage 4 of the Public Health (Wales) Bill, "Decisions", 16 March 2016

85 ASH, Will you permit or prohibit electronic cigarette use on your premises?, October 2015

86 Public Health England, Use of e-cigarettes in public places and workplaces Advice to inform evidence-based policy making, July 2016

24 The regulation of e-cigarettes

Similarly, ASH has the following ‘tips’ when formulating a workplace policy on nicotine containing products:

• Be clear about what you are trying to achieve, especially on how you are intending to improve the situation.

• Be clear about precisely what you are prohibiting –electronic cigarettes, things that could be confused with cigarettes, or both.

• Make sure your policy is good for health, by helping and not hindering smokers to reduce the harm caused by smoking to themselves and others.

• Consider the part that your policy can play in ‘renormalising’ or ‘denormalising’ the smokefree environment and promoting the right role models to children.87

3.3 Tobacco Control Plan for England A new Tobacco Control Plan for England, updating the 2011-15 Plan, was expected during the 2015-2017 Parliament but was subject to a number of delays. Early in 2017, over 1000 doctors signed an open letter to the Prime Minister, calling on her to put “her weight behind the publication of a new Tobacco Control Plan without further delay”.88 The Plan was subsequently published after the General Election on 17 July 2017.

There is no move in the new Tobacco Control Plan for e-cigarettes to be covered by the smokefree legislation. Instead, the Plan states that PHE will “support local areas looking to implement local smokefree policies differentiating the levels of harm caused by existing tobacco products including e-cigarettes and other novel products”.

The overall vision set out in the Plan is "to create a smokefree generation" which, it states, will have been achieved when "smoking prevalence is at 5% or below". Regarding e-cigarettes, the Plan reiterates that the Government is "committed to evidence-based policy making" and thus aims to:

• Help people to quit smoking by permitting innovative technologies that minimise the risk of harm.

• Maximise the availability of safer alternatives to smoking.

The Plan commits Public Health England (PHE) to updating its “evidence report on e-cigarettes and other novel nicotine delivery systems annually until the end of the Parliament in 2022”. PHE is also tasked with continuing to provide “smokers and the public with clear, evidence based and accurate information on the relative harm of nicotine, e-cigarettes, other nicotine delivery systems and smoked tobacco, to enable informed decision-making”.

87 ASH, Will you permit or prohibit electronic cigarette use on your premises?, October

2015 88 N S Hopkinson et al, The need for a new Tobacco Control Plan: an issue of justice.

Open Letter To The Prime Minister/Secretary Of State For Health, BMJ 3 January 2017

25 Commons Library Briefing, 31 October 2017

The Department of Health is identified as responsible for “monitoring the impact of regulation and policy on e-cigarettes […] in England, including evidence on safety, uptake, health impact and effectiveness of these products as smoking cessation aids”.

3.4 E-cigarette advertising Under the TPD, cross-border advertising of e-cigarettes through a number of media channels, including radio, television and print media, is prohibited. The TPD, however, does not cover domestic advertising, such as billboards. Scotland is currently considering whether to go further than both the TPD and the Tobacco and Related Products Regulations 2016. The Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 provides powers for Scottish Ministers to prohibit and restrict the advertising of vapour products (regardless of whether or not they contain nicotine) through secondary legislation, although this is not yet in place.

For more information on the advertising of e-cigarettes, please see the June 2017 Commons library briefing paper, Advertising of e-cigarette products.

26 The regulation of e-cigarettes

4. Select Committee Inquiry On 25 October 2017, the House of Commons Science and Technology Select Committee launched an Inquiry to look at the science behind e-cigarettes and the impact on health, the regulation of the products and financial implications.89 It will also look at novel tobacco products, such as ‘heat not burn.’

On the day of the launch of the inquiry, the Chair of the Committee, Norman Lamb said that whilst e-cigarettes are widely used, gaps in the research guiding sale and regulation remains:

Almost 3 million people in the UK now use e-cigarettes, but there are still significant gaps in the research guiding their regulation and sale. They are seen by some as valuable tools that will reduce the number of people smoking ‘conventional’ cigarettes, and seen by others as ‘re-normalising’ smoking for the younger generation.

We want to understand where the gaps are in the evidence base, the impact of the regulations, and the implications of this growing industry on NHS costs and the UK's public finances.90

The terms of reference of the inquiry have been published and the Committee is accepting written evidence until 8 December 2017.91

89 House of Commons Science and Technology Select Committee, E-cigarettes inquiry

launched, 25 October 2017 90 Ibid. 91 House of Commons Science and Technology Select Committee, E-cigarettes inquiry

(accessed 31 October 2017)

BRIEFING PAPER Number 8114 31 October 2017

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