Tobacco, Standardised Packaging and E-Cigarettes – England

September 2013

Note: This paper is intended as background information for the media. It is not intended as a comprehensive BMA policy paper

What are the key issues?

Although smoking is becoming less widespread, one in five adults still smoke and it continues to be a leading cause of preventable death, disease and hospital admissions.

NHS costs in the UK are estimated at £2.7 billion each year, with costs to the wider UK economy of around £2.5 billion in sick leave and lost productivity.

Recent statistics suggest1:

England

Approximately 21% of adults smoke, with this slightly more common in men than women.
Over 81,400 deaths in those aged 35 years and over are caused by smoking each year – that’s 18% of deaths in the age group.
An estimated 461,700 hospital admissions were estimated to be attributable to smoking in people aged 35 years and older.

Northern Ireland

Around 24% of people smoke.
Estimates suggest that more than 2,300 people a year die from tobacco-related illness.
Nearly 16,700 people are believed to be admitted to hospital for smoking-related illnesses each year.

Scotland

Around 24% of people smoke.
Around 13,500 deaths – some 24% of all deaths in Scotland – are caused by smoking each year.
Smoking-associated diseases cost the Scottish healthcare system an estimated £271m each year, according to calculations by the charity Action on Smoking on Health in Scotland.

Wales

Around 23% of people smoke.
Approximately 5600 premature deaths and nearly 27,700 hospital admissions a year are caused by smoking.
Estimated smoking costs for NHS Wales are more than £380 million a year, accounting for seven per cent of healthcare expenditure.

Standardised packaging

The BMA is urging the government to introduce standardised packaging, (no product branding, a uniform colour and standard typography), to reduce the appeal of smoking, particularly for young people. Most smokers start by the age of 18 and there is evidence that the design of cigarette packets appeals to young people. Children who recognise brand images are far more likely to start smoking and become part of the tragic statistics of tobacco harm. Generic packaging would help eradicate the marketing power for tobacco companies, and research suggests it would increase the impact of health warnings.

In April 2012, the government launched a UK-wide consultation on whether to introduce standardised tobacco packaging. Of nearly 2,500 detailed responses, 53% supported standardised packaging and 43% were in favour of doing nothing. The remaining 4% were neutral or opted for a different packaging option to improve public health.

Despite this, in July 2013 the Department of Health announced that they would delay the introduction of standardised packaging. In a ministerial statement, the Health Secretary, Jeremy Hunt said:

“Having carefully considered these differing views, the government has decided to wait until the emerging impact of the decision in Australia can be measured before we make a final decision on this policy in England.”

In response to the government’s decision, Dr Vivienne Nathanson, Director of Professional Activities at the British Medical Association, said:

“It is deeply disappointing that the Government has given in to the pressure from the tobacco industry and rather than pressing ahead with standard packaging it has instead kicked the policy into the long grass.

“Evidence shows that packaging is a key marketing tool for the tobacco industry and an influence on younger people who start smoking. As doctors we see firsthand the devastating effects of tobacco addiction and therefore we urge the Government to reconsider and introduce legislation forcing the industry to adopt standard packaging and help put an end to a life-long addiction that kills and destroys health.”

Evidence soon began to emerge from Australia that standardised packaging is associated with lower smoking appeal, more support for the police, and more urgency to quit among adult smokers.

In November 2013 the government announced a u-turn, launching an independent review of cigarette packaging in England.

Public Health Minister Jane Ellison said:

“We will introduce standardised tobacco packaging if, following the review and consideration of the wider issues raised we are satisfied there are sufficient ground to proceed.”

Responding to this announcement, Professor Sheila Hollins, Chair of the BMA’s Board of Science, said:

“It is welcome news that the government is set to overturn its decision from July and look again at the evidence around the benefits that introducing standardised packaging will bring about. The BMA has long campaigned for the Government to introduce standardised packaging as a way of helping smokers quit and to help non-smokers, especially children who are heavily influenced by tobacco marketing, to never start.

“As doctors we see first-hand the devastating effects of tobacco addiction and we call on the Government to make a decision quickly and to introduce this at the earliest possible opportunity in order to help put an end to a life-long addiction that kills and destroys health.”

The BMA’s progress so far

November 2013: UK government announces an independent review of cigarette packaging in England.
July 2013: Scottish Government announces its intention to introduce legislation on standardised packaging to Scottish Parliament
April 2013: Tobacco displays in large stores and cigarette vending machines banned in Scotland
March 2013: Scotland sets out a five year action plan to tackle smoking, including many BMA-backed measures
April 2012: UK-wide consultation on the use of plain packaging for tobacco products
April 2012: Tobacco displays in large stores banned in England
March 2012: Cigarette vending machines banned in Northern Ireland
February 2012: Cigarette vending machines banned in Wales
October 2011: Cigarette vending machines banned in England

The ban on smoking in public places took places in Scotland in 2006 and in England, Wales and Northern Ireland in 2007.

Steps are also being taken across the four UK nations to curtail tobacco displays and remove advertising from packaging.

In 2010, the Department of Health launched a new tobacco control strategy, aiming to halve the number of UK smokers by 2020.

What the BMA is calling for:

The UK to be tobacco free by 2035.
Introduce standardised packaging for all tobacco products.
Introduce minimum price levels for the sale of tobacco products.
Initiate a positive licensing scheme to reduce the number of tobacco outlets.
Continue to reduce marketing opportunities for tobacco companies.
Limit pro-smoking imagery in entertainment media.
Tough action on the illicit trade of tobacco products.
Adequately resourced smoking cessation services targeted at high risk groups.

E-Cigarettes

What is an e-cigarette?

Electronic cigarettes (e-cigarettes) are battery-operated products designed to replicate smoking behaviour without the use of tobacco. Some look like conventional cigarettes, while others appear more like an electronic device. Each e-cigarette consists of a cartridge of liquid nicotine, the atomizer (or heating element), a rechargeable battery, and electronics. They turn nicotine, flavour and other chemicals into a vapour that is inhaled by the user.

Regulation of e-cigarettes:

Electronic cigarettes have become increasingly popular since the mid-2000’s with their own advocacy groups, marketing and increasing online interest. ²^,³^,⁴ The legal status of e-cigarettes varies between countries. In some countries (eg. Denmark, Canada, Israel, Singapore, Australia and Uruguay) the sale, import, and marketing of e-cigarettes is either banned, regulated in various ways, or the subject of health advisories by government health organisations.⁵^,⁶ In other countries (eg. New Zealand), certain e-cigarettes are regulated as medicines and can only be purchased in pharmacies.^xi

In the UK, e-cigarettes are subject to regulation under the General Product Safety Regulations 2005, the Chemicals (Hazard Information & Packaging for Supply) Regulations 2009, and by Trading Standards.^11,⁷ There are no regulations on the sale of e-cigarettes as age restricted products, including their sale to children. ^xiii

However, in June 2013 the Medicine and Healthcare products Regulatory Agency (MHRA) announced that they will be regulating all nicotine-containing products, including e-cigarettes, but details of this regulation are still being decided (September 2013).

After the announcement, Dr. Vivienne Nathanson said...

“It is very good news that the MHRA has decided to regulate all nicotine-containing products, including e-cigarettes. We can now build on this and press for good research which looks at the efficacy and health implications of e-cigarettes. It’s really important that we find out if the hand to mouth use of e-cigarettes either breaks or reinforces smoking behaviours. We needs to know if e-cigarettes actually help smokers quit.”

What are the key issues?

There is emerging evidence that e-cigarettes are being used by some smokers to help cut down or quit; yet, they are subject to limited regulation, are not licensed as a medicine in the UK, and there is no peer-reviewed evidence that they are safe or effective for this purpose.
While e-cigarettes have the potential to reduce tobacco-related harm (by helping smokers to cut down and quit), a strong regulatory framework is required for the sale and use of e-cigarettes to:

Ensure they are safe, quality assured and effective at helping smokers to cut down or quit.

Restrict their marketing, sale and promotion so that it is only targeted at smokers as a way of cutting down and quitting, and does not appeal to non-smokers, in particular children and young people.
Prohibit their use in the workplaces and public places to limit secondhand exposure to the vapour exhaled by the user, and to ensure their use does not undermine smoking prevention and cessation by reinforcing the normalcy of cigarette use.

Health professionals should not recommend the use of e-cigarettes as smoking cessation aid or a lower risk option than continuing to smoke due to a lack of evidence of their safety and efficacy.

What the BMA is calling for:

E-cigarettes should be included in the ban on smoking in public places.
Stronger regulation in the UK.

Who uses e-cigarettes?

Emerging evidence suggests that e-cigarettes are mainly used in attempts to quit smoking.⁸^,⁹^,¹⁰^,¹¹ A 2012 Action on Smoking and Health (ASH) online survey of 10,000 adults (aged 18+) in England found that:

One fifth of smokers had tried e-cigarettes, but only a third of those who had tried them were still using them.
One out of five users of e-cigarettes has quit smoking altogether.
Four out of five e-cigarette users continues smoking, and use e-cigarettes primarily as a substitute where smoking is not allowed, and to help them quit and cut down.
Less than 1% of people who’d never smoked had tried them.

According to the findings of the Smoking Study Toolkit, in 2012, e-cigarettes were the most popular single type of nicotine product, with 7% of cigarette smokers in England also using e-cigarettes (as of October 2012). The study also found that

E-cigarette use has substituted for use of licensed nicotine products rather than growing the market.
Compared to users of licensed nicotine product users, e-cigarette users are slightly less motivated to stop smoking and less likely to have tried to stop; more likely to be male, older and to be ‘white collar’; and less cigarette dependent.

Smoking cessation, harm reduction and safety

Safety and efficacy

Advertising for e-cigarettes focuses on these products being cigarette substitutes, and survey evidence suggests that they are mainly used in attempts to quit smoking.¹² However, there has been little research on the efficacy of e-cigarettes as aids to stop smoking. In 2008, the World Health Organisation (WHO) stated that ‘the electronic cigarette is not a proven nicotine replacement therapy’. ^xi The WHO does not exclude the possibility that the e-cigarette could be useful as a smoking cessation aid, but as far as the WHO is aware, no rigorous, peer-reviewed studies have been conducted showing that the e-cigarette is a safe and effective nicotine replacement therapy.^xi There is evidence that e-cigarette products are highly variable in the efficacy of their vaporisation of nicotine,¹³ and that the labelling of nicotine levels may be inconsistent and misleading.¹⁴

The proposed benefit of e-cigarettes is to deliver nicotine without the concentrations of toxic compounds found in cigarette smoke. However, e-cigarettes have been found to contain harmful substances, and concerns have been raised about their safety.¹⁵ In 2009, the US Food and Drug Agency released results of an analysis of certain electronic cigarettes.^xviii The analysis found that e-cigarette cartridges contained carcinogens and toxic chemicals.

Analysis of two leading brands revealed:

diethylene glycol (a toxic chemical) in one cartridge at approximately 1 per cent.
tobacco-specific nitrosamines (which are human carcinogens) in half of the samples.
tobacco-specific impurities suspected of being harmful to humans (anabasine, mysomine and B-nicotyrine) in a majority of samples.^xviii

The test also suggested that quality control was inconsistent or non-existent:

cartridges labelled as nicotine-free had low levels of nicotine in all cartridges, except one.
cartridges with the same label emitted a markedly different amount of nicotine with each puff.
That one high-nicotine cartridge delivered twice the amount of nicotine compared to a nicotine inhalation product approved by the FDA.^xviii

Promotion and sales:

With the exception of statements about the product needing to be substantiated, the promotion of e-cigarettes – which includes point of-sale displays, and advertising via television, radio, print media and online – is not specifically controlled.^xii Their promotion ranges from being advertised as ‘cigarette substitutes’ and ‘a healthier alternative to smoking traditional tobacco products’, to evocative advertising with phrases such as ‘an exceptional alternative smoking experience’, ‘vape with style’ and ‘add flavour to your lifestyle’. The advertising also frequently makes positive associations with recreational activities and can incorporate celebrity endorsements. It is worth noting that the provisions of the 2002 Tobacco Advertising and Promotion Act (TAPA) prohibit any brand-sharing or connections with tobacco products.

E-cigarettes are sold online and can be bought from a variety of high street outlets, ranging from pubs, chemists and newsagents. The cost of using e-cigarettes is comparatively lower than using tobacco cigarettes – while the initial cost of the e-cigarette starter kits can be four or five times higher than a pack of 20 tobacco cigarettes, the ongoing costs (of cartridge refills and other components) is lower than that or purchasing tobacco cigarettes. This lower cost is commonly highlighted as a benefit to using e-cigarettes compared to smoking.

Strengthening the regulatory framework:

It is clear that the existing regulatory framework is inadequate in ensuring that e-cigarettes are safe and effective as a nicotine replacement therapy. This may in turn undermine cessation attempts. To be used as part of a harm reduction approach, there is a need to strengthen the regulation of e-cigarettes to ensure they are safe, quality assured and effective at helping smokers to cut down or quit. This includes the requirement for clear, unambiguous labelling and packaging that details the contents of the cartridges and the conditions for its safe use. There is also a need to restrict the marketing, sale and promotion of e-cigarettes so that it is only targeted at smokers as a way of cutting down and quitting, and does not appeal to non-smokers, in particular children and young people. Until this regulatory framework is in place, e-cigarettes should not be considered as a smoking cessation aid or a lower risk option than continuing to smoke.

Second hand vapour:

E-cigarettes produce emissions that can be seen and smelled, and presumably contain nicotine, carcinogens and other substances; however, there has been no systematic study of emissions.^viii Although e-cigarette users report that e-cigarettes produce fewer odours than regular cigarettes, they are so similar in appearance that they may lead others to believe it is acceptable to smoke.

There is also concern that e-cigarettes may undermine smoking prevention and cessation, as their use is likely to reinforce the normalcy of smoking behaviour. Of particular concern is how these devices closely resemble cigarettes, in terms of appearance, flavouring and styling, and are potentially highly attractive to children.

E-cigarettes in workplaces and enclosed public places:

Restrictions on where e-cigarettes can be used are limited and variable in the UK – ranging from being prohibited in some restaurants and workplaces, to restrictions in controlled environments.

Stronger controls are needed on where e-cigarettes can be used in order to:

Protect others from being exposed to e-cigarette vapours. While the concentrations of the constituents of these vapours (propylene glycol, glycerine, flavouring substances, and nicotine) are lower than with smoked cigarettes, ‘passive vaping’ has been found to occur with the use of e-cigarettes. ¹⁶,¹⁷,¹⁸
Ensure their use does not undermine existing restrictions on smoke-free public places and workplaces, by leading people to believe it is acceptable to smoke. Of particular concern to BMA members is their use by patients, visitors and staff in hospitals and other healthcare settings. Exposure to nicotine from e-cigarettes (either directly through their use by an individual of indirectly from the vapours they produce) may adversely impact on patients, such as those with heart or circulatory conditions, and their use may also become a source of conflict between staff and patients. Similar concerns exist in other settings, such as the use of e-cigarettes on airplanes.
Ensure their use does not undermine the success of conventional tobacco control measures by reinforcing the normalcy of smoking behaviour in a way that other nicotine containing products do not. This specifically relates to the way these devices commonly resemble tobacco cigarettes in terms of appearance, flavouring and styling that are potentially highly attractive to children. ¹⁹

¹ http://bma.org.uk/working-for-change/improving-and-protecting-health/tobacco/smoking-statistics

² Henningfield JE & Zaatari GS (2010) Electronic nicotine delivery systems: emerging science foundation for policy. Tobacco Control 19: 89-90

³ Yamin CK, Bitton A & Bates DW (2010) E-cigarettes: a rapidly growing internet phenomenon. Annals of Internal Medicine 153: 607-9

⁴ Ayer JW, Ribisl KM & Brownstein JS (2011) Tracking the rise in popularity of electronic nicotine delivery systems (electronic cigarettes) using search query surveillance. American Journal of Preventative Medicine 40: 448-53

⁵ World Health Organization (2009) Report on the scientific basis of tobacco product regulation: third report of a WHO study group. Geneva, Switzerland: World Health Organization

⁶ Arutz Sheva (29.7.09) Health Ministry bans electronic cigarettes.

⁷ Trading Standards Institute (2010) Response of the Trading Standards Institute to MHRA consultation on the regulation of nicotine containing products. Basildon, Essex: Trading Standards Institute.

⁸ Etter JF (2010) Electronic cigarettes as a method of tobacco control. British Medical Journal 343: 1238.

⁹ YouGov Survey. Sample size 10,000 adults. Fieldwork conducted between 27^th February and 16^th March 2012.

¹⁰ West R & Beard E (2012) Tobacco harm reduction: what smokers in England are doing. Proceedings of Action on Smoking and Health / Smokefree Action Coalition meeting on NICE Tobacco Harm Reduction Guidance Consultation, 25 October London

¹¹ www.smokinginengland.info (assessed 4 December 2012)

¹² Westenberger BJ (2009) US Food and Drug Administration: evaluation of e-cigarettes. St. Louis, MO: US Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis.

¹³ Goniewicz ML, Kuma T, Gawron M et al (2013) Nicotine levels in electronic cigarettes. Nicotine & Tobacco Research 15: 158-66.

¹⁴ Westenberger BJ (2009) US Food and Drug Administration: evaluation of e-cigarettes. St Louis, MO: US Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis.

¹⁵ Associated Press (16.2.12) Electronic cigarette explodes in Fla man’s mouth.

¹⁶ Schripp T, Markewitz D, Uhde E et al (2012) Does e-cigarette consumption cause passive vaping? Indoor Air Jun 2. Doi:10.111/j.1600-0668.2012.00792.x.{Epub ahead of print}

¹⁷ Pellegrino RM, Tinghino B, Mangiaracina G et al (2012) Electronic cigarettes: an evaluation of exposure to chemicals and fine particulate matter (PM). Annali di Igiene: Medicina Preventiva e di Comunita 24: 279-88.

¹⁸ McAuley TR, Hopke PK, Zhao J et al (2012) Comparison of the effects of e-cigarette vapo and cigarette smoke on indoor air quality. Inhalation Toxicology 24: 850-7

¹⁹ Hastings G, de Andrade M & Moodie C (2012) Tobacco harm reduction: the devil is in the deployment. British Medical Journal 345: e8412.