Smoking gun

The size of the e-cigarette market is already estimated to be $1.4bn, according to Wells Fargo senior analyst Bonnie Herzog, who believes consumption of e-cigarettes and other vapour products will surpass consumption of combustible cigarettes in the next decade.

E-cigarettes typically comprise a rechargeable battery, an atomizer and a reservoir or replaceable cartridge filled with liquid nicotine, commonly suspended in propylene glycol or glycerin, and flavourings, such as tobacco, coffee or bubblegum. When the user inhales, a battery-powered electrical element heats the liquid into a vapour, most of which is absorbed through the mouth, the rest evaporating. There is a huge variety of e-cigarettes, some of which resemble conventional cigarettes, while others look like pipes, pens and USB memory sticks.

It is a common misconception that nicotine is the cause of serious harm from smoking. Although nicotine is a highly addictive alkaloid that acts on the central nervous system, it is relatively harmless in the doses used in cigarettes – about as hazardous as caffeine. Most of the diseases associated with smoking, such as heart disease and cancer, are actually caused by inhaling the smoke formed from the combustion of tobacco; cigarette smoke contains thousands of toxic chemicals, including 69 known carcinogens, and is responsible for 100,000 deaths each year in the UK alone. Because e-cigarettes are tobacco-free, they deliver nicotine without the toxicants generated by conventional cigarettes – considerably safer for both smokers and bystanders.

Nevertheless, in April 2014, the US Food and Drug Administration (FDA) proposed controversial new rules that would regulate e-cigarettes as tobacco products, imposing costly demands on producers that are likely to scuttle growth of the industry. By bringing e-cigarettes under the 2009 Family Smoking Prevention and Tobacco Control Act, agency approval would be required for new and existing products, with any health claims supported by sound science. Their sale would be banned to under-18s, and producers would have to disclose manufacturing processes and ingredients and add health warning labels about nicotine content. ‘This proposed rule is the latest step in our efforts to make the next generation tobacco-free,’ said US Health and Human Services Secretary, Kathleen Sebelius.

The FDA proposals follow a review by the agency’s Center for Tobacco Products scientists of the available literature on the risks and benefits of e-cigarettes. Among the aspects they looked at were the design, chemistry and toxicology of e-cigarettes, as well as their effects on human health, children and the environment. Overall, the FDA scientists found wide variations in the way e-cigarettes are engineered and manufactured, the chemicals they contain, the nicotine they deliver, the way they are used, and a lack of robust scientific data and standardised tests (doi:10.1136/tobaccocontrol-2013-051504).

However, the quality and significance of the FDA’s findings were questioned within the wider community. Carl Phillips, scientific director of Consumer Advocates for Smoke-free Alternatives Association, for example, heavily criticised the review for being incomplete, out of date and focusing on the negative (http://antithrlies.com/2014/04/15/fda-reveals-its-views-on-ecigs-in-new-publication/). This sentiment was echoed by Clive Bates, former head of Action on Smoking and Health (ASH), who said of the review in a Tweet: ‘One-sided mass bleat exaggerates dangers, ignores benefits, has no credible analytical framework for risk.’

Meanwhile, in the UK, e-cigarettes currently are not regulated under smoke free law and users are free to use them in public places. They are subject to general consumer protection law and it is the responsibility of Trading Standards to rule on their safety. From 2016, however, e-cigarettes will be regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) as medicinal products if their manufacturers want to claim that they help with smoking cessation. If not, e-cigarettes will continue to be marketed as consumer products, but subject to restrictions set out in the EU Tobacco Products Directive.

‘Frankly, it is an utter mess,’ says Bates. ‘The use of pharmaceutical regulation is excessively burdensome, highly restrictive and very costly — it will mean most companies involved will exit, the range of products on the market will shrink dramatically and the pace of innovation will slow right down. The Tobacco Products Directive is little better: with arbitrary and pointless limits on nicotine concentration; an unjustified ban on advertising; excessive warning labels and arbitrary limits on container size for liquids.’

In the absence of thorough clinical evaluation and long-term population level surveillance, the absolute safety of e-cigarettes cannot be guaranteed. An FDA study, for example, has raised some concerns over the presence of toxins, released in low concentrations, from the vapourisation process of certain chemicals. The agency also says it is not clear how much nicotine or other potentially harmful chemicals are being inhaled.

Stanton Glantz, American Legacy Foundation Distinguished Professor of Tobacco Control, points out that acetaldehyde, cadmium, formaldehyde, isoprene, lead, nickel, nicotine, N-nitrosonornicotine and toluene – chemicals known to cause cancer or birth defects – have already been identified in mainstream or secondhand e-cigarette vapour. ‘There is no question that e-cigarettes pollute the air and that bystanders absorb nicotine from secondhand exposure,’ he says.

Additionally, according to the WHO, most electronic nicotine delivery systems contain large concentrations of propylene glycol, which is a known irritant when inhaled. And British Medical Association members have agreed that e-cigarettes should be included in the ban on smoking in public places.

Others, however, insist the risk from primary and secondhand vapour is negligible. ‘If anything, the harm seems limited to low levels of nicotine and particulate matter,’ says David Abrams, executive director at The Schroeder Institute for Tobacco Research and Policy Studies, and professor at The Johns Hopkins Bloomberg School of Public Health in the US. Abrams says the studies he has seen show the second hand vapour may be at such low levels as to be virtually undetectable in bystanders — except for nicotine at about 1/10th the level of a conventional cigarette. ‘Basically I think some in the tobacco control community are doing everything they can to downplay the benefits of e-cigarettes, mislead with fear mongering and are demonising them without good data to support their fears,’ he adds. ‘There is overwhelming evidence that any risk to bystanders is completely trivial.’

Indeed, a study published in Tobacco Control shows that the levels of toxicants in e-cigarette vapour is 9–450 times lower than in cigarette smoke and are, in many cases, comparable with trace amounts found in the reference product (doi:10.1136/tobaccocontrol-2012-050859).

While there can be contaminants or heat-related breakdown products of the ingredients of liquids, so far these have been shown to be few and at low concentrations for normal device operating temperatures, adds Bates. ‘Because the vapour itself largely comprises benign substances, there is little basis for concern about secondhand vaping beyond its nuisance effect, which is much less than for cigarette smoke.’

‘It would not be appropriate to regulate e-cigarettes exactly the same as tobacco products,’ says Robert West, professor of health psychology and director of tobacco studies at University College London, UK, and one of the scientists who has appealed to the WHO. ‘There are definitely some chemical engineering regulations that would be good for consumers, particularly including ingredient disclosure, GMP [good manufacturing practice], and perhaps batch testing for contamination,’ he says, referring to the fact that the manufacturing methods and performance of e-cigarettes currently wildly differ; chemical ingredients are often not disclosed; and few types of e-cigarette are properly tested. However, he contends that the regulations proposed by FDA, MHRA, and others ‘would be a de facto near-ban, which would be terrible for consumers and a public health disaster’.

While many believe that e-cigarettes are safer than tobacco cigarettes, the concern by agencies such as the FDA is that they could perpetuate the deaths from conventional cigarettes, if they are used as a bridge to maintain a tobacco cigarette habit (dual use) or if they act as a gateway to tobacco cigarettes for young people. ‘Evidence available at this time, although limited, points to high levels of dual use of e-cigarettes with conventional cigarettes; no proven cessation benefits; and rapidly increasing youth initiation with e-cigarettes,’ asserts Glantz (doi: 10.1161/circulationaha.114.007667).

However, there is mounting evidence that e-cigarettes are useful in helping smokers quit. A recent study in the UK has found that smokers trying to quit are much more likely to succeed if they use electronic cigarettes than OTC therapies such as nicotine patches or gum (Addiction, doi: 10.1111/add.12623).

Moreover, the number of people using e-cigarettes in the UK has tripled over the past two years to 2.1m, almost entirely made of current (two thirds) and former (one third) smokers, according to Action on Smoking and Health (ASH).

A YouGov survey of more than 12,000 smokers, commissioned by ASH and published in April 2014, shows that 71% of ex-smokers said they used e-cigarettes to help them give up smoking. ‘The dramatic rise in use of e-cigarettes over the past four years suggests that smokers are increasingly turning to these devices to help them cut down or quit smoking. Significantly, usage among non-smokers remains negligible,’ said Deborah Arnott, chief executive of ASH.

If the best strategy for public health is to increase the sales of e-cigarettes and to displace conventional cigarette sales, tobacco regulation seems highly unsuitable. ‘We need to evolve a more sophisticated approach to the risks and benefits,’ says Bates. ‘The danger is that obsessive focus on minor or theoretical risks will lead to measures that end up so restrictive that they deny us the very large potential health benefits, and in effect protect the cigarette industry from competition from better products.’

What is needed, agrees West, is bespoke regulation in which there are reasonable standards of quality control and labeling, restrictions on the way e-cigarettes can be marketed, and bans on sale to minors.

A more comprehensive nicotine regulation policy is needed that encourages complete switching away from tobacco products rather than dual use and discourages young people from progressing to more lethal combustion cigarettes, says Abrams. For instance, combusted products could be made less accessible via taxes, and less appealing by reduced nicotine and the ban of flavourings. And, so as to promote rather than stifle innovation and competition, less harmful e-cigarettes could be made as safe and accessible as possible and relatively inexpensive. Says Abrams: ‘I am cautiously optimistic that e-cigarettes will do more good than harm if prudently managed and regulated.’