Electronic/E-cigarettes. In summary

Transcription

1 Electronic/E-cigarettes In summary Although e-cigarettes are thought to be less harmful than cigarettes we cannot say they are harmless Public Health England (PHE) has recently estimated E- cigarettes to be around 95% safer than smoking cigarettes for users. While e-cigarettes have the potential to support tobacco harm reduction, any benefits or disadvantages to public health are not yet well established. At present; o These devices are unlicensed and therefore unregulated products meaning that their safety and effectiveness cannot be guaranteed in terms of nicotine content and other components including electrical o safety. There is no specific law prohibiting the use of an e-cigarette in an enclosed public place There are concerns regarding uptake of e-cigarettes by young people. Surveys (including some from America) indicate that regular electronic cigarette use among young people is relatively low and is largely among young people who smoke. The surveys do, however, show a higher level of experimentation with electronic cigarettes (young people who have tried products one or twice). New legislation commenced on 1 October 2015 including proxy sales of both tobacco and e-cigarettes and under 18s not being able to buy e-cigarettes. E-cigarettes will be regulated under one of two regulatory regimes by April 2016: 1. Opt-in medicines regulation, regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). 2. All other e-cigarettes will be regulated under the Tobacco Products Directive (TPD). Recommendations may be an interim measure based on current evidence, but may need to take in to consideration any new evidence/guidance produced in future. Overview Electronic Cigarettes (e-cigs) also known as vapourisers or electronic nicotine delivery systems (ENDS) or nicotine containing products (NCP s), are designed as an alternative to tobacco smoking. Some look and feel like conventional cigarettes; however more recent models bear less of a resemblance. In general an e-cig contains a battery, an atomiser and a cartridge. The cartridge contains a liquid or juice which is generally propylene glycol or glycerine, water and varying amounts of nicotine. The contents of these cartridges are generally toxic so it is advisable to keep devices away from children and animals who could accidentally ingest these. These liquids come in many flavours (e.g. tobacco, whisky, bubble-gum, fruit). When a user inhales via the mouthpiece, some of the liquid evaporates to allow intake to the lungs - this is often called vaping. E-cigs vary extensively in design and are made by many different companies, including tobacco companies As most harm from smoking comes from inhaling tobacco smoke rather than the nicotine, e-cigs are thought to be less harmful. However, nicotine is still an addictive drug which stimulates the nervous system, increasing the heart rate and blood pressure. Since they do not produce tobacco smoke, they have been marketed as less harmful alternatives to cigarettes and for use in places where smoking is not permitted

2 What is the issue? Safety Although E-cigarettes are thought to be less harmful than cigarettes we cannot say they are harmless. PHE has recently estimated E-cigs to carry only around 5% of the risk of smoking cigarettes for users, and exposure to vapour is similarly therefore likely to present less risk than that of secondhand smoke 1. The British Medical Association (BMA) advises that Health professionals should advise their patients to use NHS stop smoking services or a regulated and licensed product to help quit smoking. Where a patient is unable or unwilling to use these services, or to use an approved and tested nicotine replacement therapy, health professionals should help patients understand that e-cigarettes are currently unregulated and therefore their safety and efficacy cannot be assured. If asked, professionals should inform that they are likely to be a lower risk option than continuing to smoke 2 While e- cigarettes have the potential to support tobacco harm reduction, any benefits or disadvantages to public health are not yet well established. This reflects the lack of conclusive evidence of effectiveness as a smoking cessation aid, concerns regarding the variability of the components of e-cigarette vapour, and the absence of a significant health benefit associated with dual use of e-cigarettes and tobacco cigarettes. The increasing involvement of the tobacco industry in the e-cigarette market has the potential to undermine the progress made on tobacco control in the UK. At present these devices are unlicensed and therefore unregulated products meaning that their safety and effectiveness cannot be guaranteed in terms of nicotine content and other components including electrical safety There have been several recent dwelling fires attributed to e-cigarettes including a high profile one at a student flat in Nottingham city centre. These appear to be linked to electrical chargers which do not have a safety cut-off device. Use in enclosed public places At present there is no specific law prohibiting the use of an e-cigarette in an enclosed public place. The Health Act 2006 which prohibits smoking in enclosed public places refers specifically to tobacco smoke and lit products. In terms of health risks associated with use around non-e-cigarette users, the level of nicotine present in the vapour is about one tenth of that generated by a cigarette 3. Any health risks of secondhand exposure to propylene glycol vapour are not fully known but currently are thought to be limited to irritation of the throat. Under review as an aid to stopping smoking At this time these devices are not a licensed Nicotine Containing Product (NCP). Recent studies support the Cochrane Review findings that e-cigarettes can help people to quit smoking and reduce their cigarette consumption. There is also evidence that they can encourage quitting or cigarette consumption reduction even 1 PHE (2015) E-cigarettes: an evidence update: A report commissioned by Public Health England 2 BMA s Board of Science and Occupational Medicine Committee: BMA calls for stronger regulation of e-cigarettes, March 2012 (updated November 2014) 3 Czogala, J., Goniewicz, M. L., Fidelus, B., Zielinska-Danch, W., Travers, M. J., & Sobczak, A. (2013). Secondhand exposure to vapors from electronic cigarettes. Nicotine & Tobacco Research, ntt203.

3 among those not intending to quit or rejecting other support. Currently it is not known whether current e-cigarette products are more or less effective than licensed stop-smoking medications, but they are much more popular. Around 1 in 20 adults use an e-cigarette and 2/3 of these adults are smokers 1. A potential gateway to smoking There are concerns that children smoking e-cigarettes (that are often flavoured and potentially more appealing than cigarettes) could, once addicted to nicotine, progress onto smoking tobacco products. In March 2015 Action on Smoking and Health (ASH) commissioned a survey of 2,291children aged 11 to The survey found: o 7% of year olds said they had not heard of electronic cigarettes o 13% of those surveyed had tried e-cigarettes at least once, this is up from 5% in 2013 o 2.4% of respondents said they used electronic cigarettes once a month or more, including 0.5% who used them weekly o The most popular form of electronic-cigarettes among children are those with a rechargeable tank (34%) (of those who had tried e-cigarettes once or twice). In 2014 questions on electronic cigarette use were added to surveys carried out in schools by Governments in Wales Scotland and England. The patterns of electronic cigarette use among all these surveys and the ASH Smokefree GB Youth survey are similar. The surveys taken together indicate that regular electronic cigarette use among young people is a relatively rare phenomenon and is largely among young people who smoke. The surveys do, however, show a higher level of experimentation with electronic cigarettes (young people who have tried products one or twice). In America a recent national survey of teen substance abuse shows significantly more teens reported recent use of e-cigarettes than traditional cigarettes in The governmentsponsored Monitoring the Future survey is the first national survey to show teen use of e- cigarettes surpassing use of regular cigarettes and the first to report tobacco use data for It follows the release in November of the CDC s 2013 National Youth Tobacco Survey, which found that e-cigarette use among high school students tripled between 2011 and 2013 (from 1.5 percent to 4.5 percent who reported using e-cigarettes in the past 30 days) 6. However, a recent pan-wales 7 study covering year old children and 75 schools compared findings from a to a 2014 study. The 2014 study found: 6% of children had used an e-cigarette, three times more than had tried tobacco (2%) Of children with 2 smoking parents, 14% had tried e-cigarettes, compared to 4% of those with non-smoking parents Anti-smoking intentions were weaker in those who had smoked an e-cigarette (15% might or will take up smoking in the next 2 years compared to 2% of never e-cigarette smokers) The researchers conclude that e-cigarettes are a new form of childhood experimentation with nicotine, which is more prevalent than tobacco in year olds. This may be viewed 4 ASH Factsheet: Use of Electronic Cigarettes in Great Britain, Johnston et al (2014). Monitoring the future. National Survey Results on Drug Use Volume 2 College Students and Adults Ages Centre for Disease Control and Prevention (2014). Morbidity and mortality weekly report: Tobacco Use Among Middle and High School Students United States, Vol 63. No Moore, GF et al (2014). Exposure to secondhand smoke in cars and e-cigarette use among year old children in Wales. Tobacco Control

4 in a positive light as what this study highlights, is that (not surprisingly) children who live with smokers or e-cigarette users are more likely to experiment with nicotine, and at this age, this is more likely to be with e cigarettes, rather than tobacco. A recent report by the Trading Standards Institute (TSI) on youth access to e- cigarettes found 8 : o Out of 574 visits, purchases were made on 227 occasions o The highest proportion of purchases to visits made was from market stalls (80%) followed by independent pharmacies (74%). o The majority of products sold (80%) carried warnings that these products were not for sale to under-18s. o This study has highlighted that trading standards has an important role to play in preparing businesses for the change in the law and to ensure that these products are not supplied to under 18s. Since publication of the report the law has recently changed (1 October 2015) to restrict the access of young people to these products. It is now an offence to sell e-cigarettes to children under 18 including proxy purchasing (purchasing or attempting to purchase products for someone under the age of 18). The re-normalisation of smoking De-normalisation of smoking is part of the Tobacco Control agenda, especially in order to dissuade young people from starting. If e-cigarettes are smoked in public places this could erode the message. Furthermore smoking e-cigarettes in the workplace could also undermine the smokefree aims and could give mixed messages to public and other staff about smoking. Progress to date The National Institute of Care Excellence (NICE) published its own guidance in June 2013 on Harm Reduction and suggested that unlicensed nicotine containing products (such as e-cigarettes) cannot be provided for support to stop smoking or as a harm reduction measure, although if individuals wish to use such products (which they purchase themselves) then this should not be discouraged Nottinghamshire County Council (and other local authorities) has amended its smokefree workplace policy to cover e-cigarettes colleagues and visitors are prohibited from using them in Council buildings. This is an interim position until further evidence is available. In Nottinghamshire County, Trading Standards colleagues raise awareness on the safety of these products and regularly test products to ensure they comply with the current legislation. They have produced a helpful leaflet which is available on request. Trading Standards have also been working with Nottinghamshire Fire and Rescue service to build up a picture and issues around the safety of electronic cigarettes. New legislation commenced on 1 October 2015 as part of the amendments to the Children and Families Bill, on 10 February The legislation bans smoking in cars when someone under 18 is present. 8 Trading Standards Institute: Youth Access to E cigarettes and associated products. July 2014

5 Two other major changes in the law relating to smoking in England and Wales have also come into effect: o Proxy sales of both tobacco and e-cigarettes, meaning it will be an offence for an adult to buy (or attempt to buy) tobacco or e-cigarettes for under 18s o Under 18s will not be able to buy e-cigarettes, people caught selling these products could face a fine of up to 2,500 The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced in June 2013 that all e-cigarettes would be licensed as a medicine by Since this time there have been changes to the European Union (EU) Tobacco Products Directive (TDP), which means that only products meeting certain criteria (please refer to EU TDP below) will be regulated as medicines and all other products will be covered by TDP regulations. Implications of the European Union (EU) Tobacco Products Directive (TDP) o A revision to the 2001 EU TDP was passed by parliament on 26 February The Directive came into effect on 19 May 2014; however individual member states have 2 years until 2016 to implement the law. o The new law includes specific regulations relating to e-cigarettes NOT licensed as a medicine. o E cigarettes will therefore be regulated under one of two regulatory regimes: 1. Opt-in medicines regulation, regulated by the MHRA. Products regulated under this regime will be able to advertise in line with the products rational use, will have to comply with safety and quality standards set out by the MHRA, will be able to make health claims and will attract a lower rate of VAT. We expect products licensed as medicines to start coming on to the market soon. It also means products can be made available on prescription. 2. All other e-cigarettes will be regulated under the TPD. Regulations include: restricting advertising (no cross-border), requiring safety fastenings on liquids to prevent children from accessing them, manufacturers will have to provide detailed information about their products and take responsibility for quality and safety. They will also have warnings about nicotine content. Any product over 20mg/ml will have to be licensed as a medicine. o For manufacturers of electronic cigarettes, option 1, licensing the product as a medicine is arguably more attractive given the lower levels of taxation, increased ability to advertise and make health claims about the product. o Products that do not contain nicotine are not covered by the Directive. o Measures in the TPD have to be in place by 2016, therefore until this time caution should be taken when using an electronic cigarette, unless the product is regulated as a medicine, in which case people opting to use products licensed as a medicine, can therefore do so with "the confidence that they are safe, of the right quality and work 9. The Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice (BCAP), which creates the rules for advertising and marketing in the UK, suggested that new rules were required to address growing public concern about the now widespread advertising of e-cigarettes. 9 Press Release: UK Moves towards safe and effective electronic cigarettes and other nicotine-containing products, MHRA, 12 June 2013

6 Following a public consultation, new rules came into force on 10 November 2014 Key measures include: o Ads must not be likely to appeal to people under 18 o People shown using e-cigarettes must neither be, nor seem to be under 25 o Ads must not be directed at people under 18 through the selection of media or the context in which they appear o Ads must not encourage non-smokers or non-nicotine users to use electronic o o cigarettes Ads must make clear that the product is an e-cigarette and not a tobacco product. These rules are intended to cover the interim period ahead of the UK implementation of the measures in the EU Tobacco Products Directive. The rules do not include the prohibition of celebrity endorsement and free samples, which is of concern. The inclusion of these measures were suggested by Action on Smoking and Health (ASH) as part of the consultation and supported by the Nottinghamshire Strategic Tobacco Alliance Group. Since the new rules have come into force 3 television adverts have been banned for glamourising the smoking of tobacco products and encouraging ex-smokers to use e- cigarettes. CAP will monitor the effect of the rules and conduct a review after 12 months. Public Health England has recently developed a report on the evidence to date regarding E-cigarettes. Report can be accessed here: Key messages and findings: o The current best estimate by PHE is that e-cigarettes are thought to be 95% less harmful than smoking o Nearly half the population (44.8%) don t realise e-cigarettes are much less harmful than smoking o There is no evidence so far that e-cigarettes are acting as a route into smoking for children or non-smokers in the UK. Recommendations/Opportunities Locally we want as many people to stop smoking as possible and to reduce the harm tobacco use has on families and communities. Our local stop smoking services are e- cigarette friendly and although they cannot supply the e-cigarettes, they can provide that vital behavioural support and free or subsided licensed nicotine replacement products that can make the all-important difference in helping people to stop smoking Currently, the use of e-cigarettes in Nottinghamshire and Nottingham City (this includes in workplaces, clinical settings, educational settings) is not recommended due to the products being unlicensed and uncertainties as listed above. Recommended licensed nicotine containing products (e.g. patches) should continue to be promoted to people wishing to stop smoking or for harm reduction. Continue to work with local councils and partners to review smokefree policies for workplaces and update guidance to include the use of e-cigarettes. It should be noted that the recommendations above are an interim measure based on current evidence and this is on-going work which will take into consideration any new evidence/guidance produced in future.

7 Weblinks for further information: ettes_an_evidence_update_a_report_commissioned_by_public_health_england_final.pdf