A Consultation on Electronic Cigarettes and Strengthening Tobacco Control in Scotland

E-cigarettes

Electronic cigarettes, e-cigarettes or ENDS (electronic nicotine delivery systems) are battery operated, vapour inhaler devices. They are used to vaporise and deliver a chemical mixture typically composed of propylene glycol, flavouring agents and nicotine; although non-nicotine options are also available. Some e-cigarettes are disposable and some are rechargeable^[5]. Throughout this document, we will refer to these products as e-cigarettes.

The e-cigarette was developed as an alternative to traditional tobacco products. While a traditional cigarette is lit (for example by a lighter or a match) an e-cigarette is generally heated via the battery although products are emerging which have no electronic features and are charged with compressed air instead. A traditional cigarette contains tobacco; the vast majority of e-cigarettes do not. However, the technology is developing rapidly and there are now some products on the market which are capable of containing tobacco as part of the mixture that is vaporised by the e-cigarette. While some initial e-cigarettes adopted the form and look of a traditional tobacco cigarette, as the market develops, there is an increasing range of shapes, sizes and colours of e-cigarettes available.

E-cigarettes are not considered the same as licensed Nicotine Replacement Therapy. However, some specific e-cigarette products could be licensed as nicotine-containing products in the future if they applied for, and were granted, a medicines licence. One product, which contains compressed air rather than a heating element, has recently been successful in applying for a medicines licence in the UK^[6]. Nicotine Replacement therapy is on the World Health Organisation's list of essential medicines^[7] and mainly comes in the form of patches, gum or inhalators. They have longstanding safety and effectiveness profiles and almost exclusively contain nicotine. Nicotine replacement therapy can be bought directly from shops or chemists or can be provided on prescription. In the UK, Nicotine Replacement Therapy products are granted a medicines licence from the Medicines and Healthcare Products Regulatory Agency after a rigorous testing process. If an e-cigarette manufacturer wanted their product to become a licensed nicotine-containing product, they would have to apply to the Medicines and Healthcare products Regulatory Agency. The options in the consultation paper are therefore concerned with regulating non-medicinal e-cigarettes only.

E-cigarettes have been on the market for less than a decade but there has been a significant increase in availability and take up of these products in recent years in Scotland^[8] as in other parts of the UK^[9]. In response to a need for regulation of these products across Europe, the recently revised European Tobacco Products Directive^[10] set a Framework for the regulation of e-cigarettes, which will be implemented across the UK by May 2016. Under the terms of the European Directive, e-cigarettes that do not voluntarily seek a medicines licence will continue to be regulated as consumer products but with a range of additional safeguards for consumers. These regulatory safeguards include:

• a limitation on the nicotine content;
• a requirement for manufacturers and importers to report on ingredients in and emissions resulting from the use of e-cigarettes and provide toxicological data;
• a requirement for the provision of information to consumers, including a health warning on packaging; and
• restrictions on advertising and promotion with a cross-border impact, including on TV, radio, the internet and events sponsorship.

There are a number of areas that the European Directive does not regulate. These include certain domestic advertising (such as billboards, leaflets and posters), whether to restrict flavours, whether to ban use in certain areas in line with smoke-free legislation and whether to implement a minimum age for sale or use.

Our Strategy, Creating a Tobacco-Free Generation, included a commitment to continue to respond to market developments, which may promote or normalise smoking behaviours. It also included a specific commitment to consider what further action on e-cigarettes might be required in Scotland to protect public health following the publication of the European Directive.

There is much debate amongst academics about the potential benefit and risk of e-cigarettes. The main points of the debate can be set out in three key themes: safety, usefulness as a quitting tool and impact on tobacco control efforts.

Safety

E-cigarettes are relatively new products and it will take some time before we can properly understand the impacts of their use on health (for individual users and for the wider population). Until the European Directive comes into force they are subject to very little regulation.

There are uncertainties about safety. It will take some time to monitor the long-term effects on people who use them and on bystanders exposed to second-hand vapour. Even with the safety regulations introduced by the European Directive, adverse health impacts may come to light over time. For example, we do not know what effects there might be from long-term inhalation of nicotine and the other permitted ingredients in e-cigarettes.

While there is widespread agreement that these products present much less risk for users and bystanders than traditional combustible tobacco products, it is not possible to say that they are risk free.

Role in stopping smoking and harm reduction

There is on-going debate over the potential value of e-cigarettes as aids to help people quit smoking. There is some evidence from former smokers that e-cigarettes have helped them quit and they may especially help smokers who have been unable to quit with traditional Nicotine Replacement Therapy. However, the evidence is limited and more research is needed which follows individuals over time to understand the role of e-cigarettes as quitting aids, and whether they help people to stop smoking over the long term. There is concern around dual use, for example, in terms of whether some people who smoke tobacco and use e-cigarettes may be less motivated to quit.

Tobacco control and renormalisation of smoking behaviours

Protecting young people has always been at the core of Scottish Government tobacco policies and will continue to guide us through our considerations for policy options on e-cigarettes. While the Scottish Government remains open-minded on the potential benefits of these products to current smokers, we need to ensure that they are regulated in a way which limits their attractiveness and accessibility to non-smokers, and in particular, to young people.

A great deal has been achieved through efforts to reduce exposure to tobacco products and smoking behaviours such as legislation to ban the advertising and display of tobacco, the ban on smoking in enclosed public spaces and campaigns to raise awareness about the dangers of smoking.

There is real concern that a possible modelling of smoking behaviours can occur as the use of e-cigarettes mimics the use of tobacco and may undermine tobacco control efforts. Some fear that an unintended consequence of the use of e-cigarettes (and particularly consequent nicotine addiction) could lead to tobacco use amongst non-smokers, particularly young people. Indeed the Parliament and Council of Europe set out in the Tobacco Products Directive that 'electronic cigarettes can develop into a gateway to nicotine addiction and ultimately traditional tobacco consumption, as they mimic and normalise the action of smoking'^[11]. Given the addictive nature of nicotine and the clear and well established health harms of tobacco, this is a risk that the Scottish Government must carefully consider.

Age restriction for e-cigarettes

There is currently no restriction on the age that a young person can purchase an e-cigarette in Scotland. We know that nicotine is extremely addictive and evidence for tobacco has shown that the younger an individual starts to smoke, the more likely they are to be an adult smoker, the heavier they are likely to smoke during adulthood and the more likely they are to fall ill and die early as a result of smoking.^[12]

As nicotine is the addictive component of tobacco, it is reasonable to assume that the younger an individual becomes addicted to nicotine through e-cigarette use, the longer the addiction could last.

There has been co-operation across retailers and manufacturers to implement a voluntary age-restriction on the sale of e-cigarettes to adults aged 18 and over. Earlier this year the Electronic Cigarette Industry Trade Association welcomed the UK Government's announcement that it would introduce an age restriction^[13]. However, there is evidence that the voluntary trade practice is not preventing young people from obtaining e-cigarettes.

Evidence about rates of use and access by young people is limited but improving. In Scotland, we will have the first robust data on under-18 e-cigarette use in November 2014.^[14] A number of surveys already show that a small proportion of young people have tried or use e-cigarettes, typically regular tobacco smokers. ^[15]

An e-cigarette test-purchasing exercise in England also found that of 574 visits made by young people in March 2014, successful purchases were made by a child on 227 occasions (40%), despite 80% of the products purchased carrying an age-restriction warning^[16]. While we recognise that the evidence base for e-cigarette use continues to develop, there is a clear indication that young people are accessing e-cigarettes which have either been purchased by themselves or provided by someone else.

Due to the addictive nature of nicotine and the risk of promoting smoking behaviours, the Scottish Government believes it is appropriate to introduce legislation that will restrict children and young people's access to e-cigarettes and refills. This would bring the sale of e-cigarettes into line with other age-restricted products such as alcohol, tobacco and solvents. Similar action is being progressed in England, Wales and Northern Ireland.

Limited exemptions may apply to e-cigarette devices which become licensed as a medicinal product. Age restrictions for these products would be a matter for the Medicines and Healthcare products Regulatory Agency.

If an age restriction were introduced, proof of age requirements would be consistent with those for other age-restricted goods in Scotland. These include a passport, a photocard driving licence or a photographic identity card bearing the National Proof of Age Standards Scheme hologram such as the Young Scot National Entitlement Card^[17].

In line with tobacco sales legislation, we propose that all sales of e-cigarettes and e-cigarette refills from self-service vending machines should be banned. This is because proof of age cannot be verified.

We propose that enforcement of this measure would be consistent with other non-licensed age-restricted consumer products. This would be an extension to the role of Local Authority Trading Standards Officers.

We propose that an offence for selling an e-cigarette to a child or young person under the age of 18 would be liable on summary conviction to a fine not exceeding level 4 on the standard scale, the same as that for sales of tobacco to those under the age of 18. If an offence is also applied to the child or young person purchasing an e-cigarette, we propose that it is liable on summary conviction to a fine not exceeding level 1 on the standard scale, the same as that for sales of tobacco.

1. Should the minimum age of sale for e-cigarette devices, refills (e-liquids) be set at 18?

2. Should age of sale regulations apply to:
a.only e-cigarette devices / refills (e-liquids) that contain nicotine or are capable of containing nicotine, or
b.all devices / refills (e-liquids) regardless of whether they contain or are capable of containing nicotine?

3. Whom should the offence apply to:
a.the retailer selling the e-cigarette;
b.the young person attempting to purchase the e-cigarette; or
c.both?

4. Should sales of e-cigarette devices and refills (e-liquids) from self-service vending machines be banned?

5. Should a restriction be in place for other e-cigarette accessories?

6. If you answered 'yes', to question 5, which products should have restrictions applied to them?

Proxy purchase for e-cigarettes

If an age restriction were implemented to prevent children and young people under the age of 18 from purchasing e-cigarettes and refill products, it would still be possible for someone aged 18 and over to purchase an e-cigarette and supply it to a young person under the age of 18. This is known as 'proxy purchasing'. We propose introducing legislation to make it an offence for an adult to purchase a e-cigarette and supply it to a child or young person under the age of 18.

It is already an offence to proxy purchase tobacco. We propose that the e-cigarette proxy purchase offence is liable on summary conviction to a fine not exceeding level 5 on the standard scale. This is in line with proxy purchase of tobacco products.

7. Should the Scottish Government introduce legislation to make it an offence to proxy purchase e-cigarettes?

Domestic advertising and promotion of e-cigarettes

The role of advertising and promotion has long been understood as contributing to the take up of tobacco use. A well-established evidence base has underpinned a range of legislative measures to protect young people from exposure to tobacco advertising. These include the 2002 tobacco advertising ban^[18], recent legislation to ban tobacco displays in shops^[19] and the current development of regulations on standardised packaging of tobacco products^[20].

Most recently, the independent review of the evidence^[21] for standardised packaging of tobacco products reiterated that pro-smoking imagery and role modelling contributes to smoking normalisation. This is relevant to our considerations for e-cigarettes because their use mimics smoking behaviour. There is also concern that the marketing of e-cigarettes can suggest that people should only quit tobacco use, inferring that nicotine addiction in itself is of no concern.

Formal analysis of the content of websites, adverts and promotional materials (including a study in the UK commissioned by Cancer Research UK)^[22], provides evidence that some e-cigarette advertising is specifically aimed at a young audience.

The European Tobacco Products Directive^[23] recognises the need for action here. By May 2016, certain advertising and promotion of e-cigarettes will be banned. This includes:

• Telecommunications (communication over a distance by cable, telegraph, telephone, or broadcasting)
• Radio
• Internet
• Most publications (e.g. newspapers)
• Events marketing with a cross-border effect (such as televised sporting events)

While the Tobacco Products Directive does not cover purely domestic forms of advertising, it does encourage Member States to consider regulation within their own jurisdiction.

This could include:

• Bill boards;
• Leafleting;
• Brand-stretching (the process of using an existing brand name for new products or services that may not seem related);
• Free distribution (marketing a product by giving it away free);
• Nominal pricing (marketing a product by selling it at a low price);
• Point of sale advertising (advertising for products and services at the places where they are bought); and
• Events sponsorship within a purely domestic setting.

Although public health experts remain divided on many of the issues that relate to e-cigarettes, there appears to be broad consensus that advertising and marketing of these products should not be aimed at young people^{[24] [25]} . However, some have argued that it is unworkable to distinguish between advertising aimed at young people and adults or between smokers and non-smokers. Others have argued that a total ban on the advertising and promotion of e-cigarettes would restrict the availability of information about, and the accessibility of e-cigarettes for, current smokers which could then reduce the likelihood that they will use e-cigarettes as a cessation tool or reducing their tobacco use.

In line with our policy aim of protecting people, but in particular young people, from the promotion of e-cigarettes and smoking behaviours, the Scottish Government would like to invite views on what forms of domestic advertising and promotion, if any, should be regulated in Scotland.

8.Should young people and adult non-smokers be protected from any form of advertising and promotion of e-cigarettes?

9.In addition to the regulations that will be introduced by the Tobacco Products Directive do you believe that the Scottish Government should take further steps to regulate domestic advertising and promotion of e-cigarettes?

10.If you believe that regulations are required, what types of domestic advertising and promotion should be regulated?
a.Bill boards;
b.Leafleting;
c.Brand-stretching (the process of using an existing brand name for new products or services that may not seem related);
d.Free distribution (marketing a product by giving it away free);
e.Nominal pricing (marketing a product by selling at a low price);
f.Point of sale advertising (advertising for products and services at the places where they are bought); or
g.Events sponsorship within a domestic setting?

11.If you believe that domestic advertising and promotion should be regulated, what, if any, exemptions should apply?

12.Are you aware of any information or evidence that you think the Scottish Government should consider in relation to regulating domestic adverting in relation to impacts on children and adults (including smokers and non-smokers)?

13.Are you aware of any information or evidence that you think the Scottish Government should consider in relation to regulating domestic adverting in relation to impacts on business, including retailers, distributers and manufacturers?

Inclusion of electronic cigarettes on the Scottish Tobacco Retailer Register

The Scottish Tobacco Retailers Register was introduced by the Tobacco and Primary Medical Services (Scotland) Act 2010^[26]. The Register was introduced because international experience had shown that age restrictions on the sale of tobacco products were more difficult to enforce effectively without licensing^[27]. The Register allows retailers to be clearly identified without the introduction of a full licensing scheme. It also enables Trading Standards officers and others to offer advice and support to them to avoid illegal sales.

Retailers who sell e-cigarettes and refills, in addition to tobacco products, are already required by law to register because they sell tobacco. However, there is no way of knowing which retailers on the Tobacco Register also sell e-cigarettes. There is an increasing number of independent shops, pop-up kiosks, pharmacies and other outlets which sell e-cigarettes but not tobacco.

If an age restriction for e-cigarettes is introduced, it will be necessary to enforce this measure in a higher number and diverse range of available outlets than is currently the case for tobacco products. Including e-cigarettes and e-cigarette refills on the Register would assist with advice, support and enforcement of measures, such as the introduction of an e-cigarette age restriction. Recognising that the name of the register may need to change, this would mean that retailers who are already registered to sell tobacco products would be required to update their registration, if they also sell e-cigarettes. Any other e-cigarette retailers would be required to register their premises.

We anticipate that the offence of selling e-cigarettes without registration, or an updated registration, will be liable on summary conviction to a fine not exceeding £20,000, or imprisonment for a term not exceeding 6 months, or both. This is in line with the offence for selling tobacco products without being registered.

14.Do you agree that retailers selling e-cigarettes and refills should be required to register on the Scottish Tobacco Retailers Register?

15.Do you agree that the offences and penalties should reflect those already in place for the Scottish Tobacco Retailers Register?

16.If you answered 'no' to question 15, what offences and penalties should be applied?

E-cigarettes - use in enclosed public spaces

Smoking in public places is banned under the Smoking, Health and Social Care (Scotland) Act 2005^[28]. E-cigarettes are not covered by this legislation; however, a number of public and private sector organisations including work places, public transport, hotels, universities and others have introduced voluntary bans on e-cigarettes to bring their policies into line with legislation on tobacco.

The Scottish Government are aware that there are many views on whether to legislate for where e-cigarettes may be used^{[29] [30]} . Public Health experts around the world are divided on the long-term health impacts of e-cigarettes and whether there is a risk to others from second-hand vapour.

There is concern amongst some experts that e-cigarettes may re-normalise smoking-like behaviours which have been made socially unacceptable and that they could undermine existing smoke-free legislation implemented in Scotland in 2006. This concern could increase as e-cigarette products come on the market that vaporise tobacco. Environmental Health officers have responsibility for enforcing current smoke-free legislation. The Royal Environmental Health Institute for Scotland (REHIS) and the British Medical Association have recently called on the Scottish Government to ban the use of e-cigarettes in enclosed public places.

The Scottish Government recognise that there is not yet sufficient evidence to fully understand: the potential impact of e-cigarettes on existing smoke-free legislation; whether or not second-hand vapour may be harmful to bystanders; or the long-term health impacts for users. We also acknowledge that individual organisations and service providers can already act to include e-cigarettes in their own HR policies or apply rules on their use on the premises, such as pubs, clubs and public transport.

The Scottish Government remains open-minded about what, if any, intervention is necessary on the use of e-cigarettes in indoor spaces. While we are clear that there are no plans to legislate at this time, we would like to invite views, suggestions and evidence that you think should be considered for longer term policy development. These could include:

• No action;
• Scottish Government actively supports and encourages individual organisations to agree their own policies on the restriction of e-cigarettes;
• Scottish Government consults with organisations to develop national guidance;
• Consider amending current smoke-free legislation to include e-cigarettes, which would mean they could not be used in any significantly enclosed public area;
• Consider legislation to ban e-cigarette use in designated public spaces (for example, those frequented most by children and families); or
• Consider a ban on use of certain e-cigarette products in enclosed public spaces (for example, those which include tobacco or look most like and behave most like traditional tobacco products).

17.Do you believe that the Scottish Government should take action on the use of e-cigarettes in enclosed public spaces?

18.If you answered 'yes' to Question 17, what action do you think the Scottish Government should take and what are your reasons for this?

19.If you answered, 'no' to Question 17, please give reasons for your answer.

20.Are you aware of any evidence, relevant to the used of e-cigarettes in enclosed spaces, that you think the Scottish Government should consider?