E-cigarettes latest: users on the up but rules tighten

What’s the latest market intelligence on e-cigarettes?

Only one company was making e-cigarettes in 2005, but today there are 466 brands in a market estimated to be worth £1.8bn (€2.3bn; $3bn).1 Many early, small scale companies making e-cigarettes have been swallowed up by tobacco manufacturers. In January 2014 there were 7764 unique flavours on the market, including menthol, fruits, candies, alcoholic drinks, and snacks.2

Around 2.1 million people in the United Kingdom reported regularly using e-cigarettes in 2014, up from 700 000 in 2012.3 In 2010 just 8% of current or former smokers had tried e-cigarettes, but now more than half (52%) have.

It has been estimated that in the European Union 23 million smokers, 3.9 million former smokers, and 2.3 million non-smokers had used e-cigarettes in 2012.4

What’s the latest evidence on whether e-cigarettes help people quit smoking?

Proponents of e-cigarettes argue that they are a safe alternative to cigarettes and are often used by smokers who are trying to wean themselves from tobacco smoking. A recent, widely quoted study showed that smoking e-cigarettes could help some people quit but that they were no more effective than other forms of nicotine replacement.5 Most people who quit smoking do so without any help.

Is there any evidence that e-cigarettes are a gateway to tobacco products?

Many public health officials are concerned that e-cigarettes encourage tobacco use by addicting users to nicotine and by making smoking more socially acceptable. Some commentators have said that children are especially vulnerable, as they are at risk of getting hooked on nicotine and then turn to conventional cigarettes, thus increasing the prevalence of smoking. E-cigarettes may also sustain smoking among smokers who might otherwise have quit or may cause former smokers to begin smoking again.

Most of the evidence indicating that children are increasingly turning to e-cigarettes comes from the United States. One report found that in 2012 6.8% of 11-18 year olds in the US had used e-cigarettes, up from 3.3% in 2011 (P<0.05).6 Nearly a 10th of those who had tried an e-cigarette said they had never smoked conventional cigarettes. The study also showed that current use (use on one or more days in the past month) rose from 1.1% to 2.1% (P<0.05) over the same period in this age group.

In March this year a study in JAMA Paediatrics found a similar increase in e-cigarette use among US teenagers.7 It also found that adolescents who used e-cigarettes were more likely to have smoked or currently smoke conventional cigarettes and less likely to quit smoking. The researchers labelled e-cigarettes “gateway devices” that aggravated rather than ameliorated “the tobacco epidemic among youth.”

In August 2014 a study by the US Centers for Disease Control and Prevention found that 263 000 non-smoking students tried e-cigarettes in 2013, compared with just 79 000 in 2011.8 The researchers also found that non-smoking students who had tried e-cigarettes were twice as likely to say that they intended to smoke conventional cigarettes within the next year as were those who had never used e-cigarettes (44% v 22%).

The UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) found that most vapers were current or former smokers and that there was little evidence of use of e-cigarettes by children who weren’t already smokers.9 So while e-cigarettes are gaining popularity and might sustain smoking in current smokers, whether they encourage non-smokers to take up tobacco is unclear.

How are e-cigarettes currently regulated?

In the UK e-cigarettes are regulated as medicines only if they claim to be an aid to reducing or stopping smoking. One such device—known as a nicotine inhaler rather than an e-cigarette—was granted a medicine licence in September 2014 and is awaiting approval of the delivery component. All other e-cigarette devices are seen as consumer products that anyone can buy.

In 2013 the MHRA announced that it would regulate e-cigarettes as medicines from 2016 to ensure their safety and quality.9 If regulated as medicines e-cigarettes cannot be promoted to people aged under 16 and their packaging and flavouring cannot be designed to attract young smokers. But that was before the European parliament passed the European Tobacco Products Directive in February.10 This states that only products containing >2 mg/mL nicotine need to be approved as a medicine, and the UK will adopt the directive as it stands. Most e-cigarettes contain less nicotine than this and will continue to be regulated as consumer products.

But the directive stipulates certain quality and safety standards that consumer devices must meet, such as delivering the same dose with each inhalation. Member states are also required to monitor the market for evidence of nicotine addiction and the effect on consumption of traditional cigarettes. Manufacturers of e-cigarettes must notify authorities when they are launching a new product and report their sales every year after the directive comes into force in May 2016.

The Department of Health for England has said that it plans to consult shortly on whether the government should ban the sale of e-cigarettes to under 18s.

What about advertising of e-cigarettes?

A key complaint from health campaigners is that e-cigarettes are “re-normalising” and glamorising vaping by using images that were previously used to promote smoking. E-cigarette advertising is currently without special regulations, but new rules will come into force in the UK on 10 November.11 These say that advertisements for e-cigarettes should not target under 18s, be associated with youth culture, or feature anyone who is, or seems to be, under 25. But celebrity endorsement is allowed, as are advertisements on television showing the devices, which have not been allowed previously. Doctors have criticised the fact that celebrities can endorse e-cigarettes and that free samples can be handed out to the public.

The European Tobacco Products Directive bans cross border advertising, so television, radio, the internet, and newspapers will not be able to carry advertisements for e-cigarettes from May 2016. Countries can decide whether to ban local advertising, such as on billboards and buses. The Department of Health for England said it will consult next spring on whether further rules on advertising e-cigarettes are needed.

What do the experts think?

There are two camps. The World Health Organization and the BMA have warned that the safety of e-cigarettes is unproved and that their role in helping people quit lacks evidence. Some public health experts have said that e-cigarettes release several toxic substances that could harm health, including ultrafine particles, propylene glycol, tobacco specific nitrosamines, nicotine, and volatile organic compounds, as well as carcinogens and reproductive toxins including benzene, lead, and nickel. They said that nicotine itself is not without harms, which is why other nicotine replacement therapies are regulated as medicines.12

There are also concerns that the quality and safety of the devices are not guaranteed because they are regulated as consumer products. An investigation by the MHRA earlier this year found that levels of nicotine often did not match those listed on the label and varied from batch to batch. Devices were often poorly manufactured or contained contaminants, and some leaked.8

In July WHO called for countries to tighten rules on the use of e-cigarettes, which included minimising their potential health risks, prohibiting unproved health claims, banning their use indoors, and preventing their sale to minors.1

In the other camp, some smoking cessation specialists have hit out at WHO, arguing that e-cigarettes are much safer than conventional cigarettes and that they are rarely used by non-smokers. The evidence on their effectiveness and their effect on other areas of tobacco control is still being gathered, they said, and over-regulation would stifle innovation, make it harder to bring new products to market, and maintain the monopoly of tobacco in the nicotine market.13

What they’ve said

Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine, said, “Many well respected public health professionals have advocated e-cigarettes as a form of harm reduction, as they are obviously much safer than smoking real cigarettes. But this may be missing the point. There are many other ways for people who cannot shake off their addiction to get their nicotine fix, none of which have the enormous downside of glamorising smoking again.”14

Ann McNeill, of the UK Centre for Tobacco and Alcohol Studies at King’s College London, said, “E-cigarettes are new, and we certainly don’t have all the answers as to their long term health impact, but what we do know is that they are much safer than cigarettes, which kill over six million people a year worldwide.”13

Linda McAvan, the Labour member of the European Parliament for Yorkshire and Humber and lead negotiator on the directive, said, “We know that it is children, not adults, who start smoking. And despite the downward trend in most member states of adult smokers, the World Health Organization figures show worrying upward trends in a number of our member states of young smokers. We need to stop tobacco companies targeting young people with an array of gimmicky products.”15