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Policy and Regulation of e-cigarettes

Policy and Regulation of e-cigarettes

The formulation of rational policies and regulations on e-cigarettes is challenging due to the limited scientific evidence on their safety, and efficacy for cessation or harm reduction.

Ideally policies and regulations should be based on a balanced assessment of the benefits and risks at an individual and population level.

At the individual level, potential harms from e-cigarette use should be balanced against the abundant evidence of the serious harm caused by tobacco use, and the possibility that overly restrictive regulations may prevent access to a less harmful product and perpetuate continued use of tobacco cigarettes.

At the population level, the assessment should include consideration of the potential of e-cigarettes to reduce smoking prevalence and reduce second-hand smoke exposure, but should also take into account the potential to cause harm through progression to tobacco use, and relapse to tobacco use in previous smokers.

A wide range of perspectives on how best to proceed has been published (for example, see: Wollscheid & Kremzner, 2009; Caponnetto et al., 2012; O’Connor, 2012; Cobb & Abrams, 2011; Gartner et al., 2012; Wagener et al., 2012; Bauld, 2012; Cobb et al., 2012; Etter, 2012; Hajek, 2012; Hajek et al, 2013; Cobb & Cobb, 2013; Abrams, 2014).   

International agencies (for example WHO, 2012) are preparing recommendations and regulatory authorities in many countries are investigating, planning to or introducing restrictions on the quality, marketing, sale and use of e-cigarettes.

The evidence to date indicates that the use of e-cigarettes is considerably less harmful than the use of tobacco cigarettes and for those currently exposed to second-hand tobacco smoke. E-cigarettes also appear to be at least modestly effective or at least as effective as medicinal nicotine at assisting smokers to quit smoking.

On the basis of the current evidence, regulatory measures should be commensurate with the harms relative to tobacco cigarettes. Too heavy-handed a response based on hypothetical concerns could deprive smokers of an almost certainly less harmful substitute, and thus cause mass harm.

If e-cigarettes can be developed to become more reliable, satisfying, readily available and at least as affordable, and preferably more affordable to smokers as tobacco cigarettes, there will be little incentive for smokers to continue to smoke far more harmful cigarettes. Therefore, if regulation too tightly restricts access to e-cigarettes the risks posed by smoking tobacco will continue to be present for many people and the majority of smokers will be forced to continue smoking highly dangerous tobacco cigarettes (Etter, 2013; Hajek et al., 2013).

On the other hand, legitimization of the tobacco industry, with e-cigarettes the catalyst, might allow greater industry influence on other policies.

Wider public health considerations include the benefits or harms that might occur in population groups with higher levels of tobacco use, such as indigenous peoples or people with low incomes.

Consideration of potential harms should include the risks of accidental ingestion of e-liquid (although the degree of risk from ingesting e-cigarette liquids containing large amounts of nicotine is not supported by Mayer’s (2014) review), the risks to children (Durmowicz, 2014), or as yet unknown health risks from long-term e-cigarette use.

Regulatory measures could include the following:

Introducing quality standards and monitoring of devices, cartridges, bottles and contents: There is an urgent need for at least minimal interim standards for product quality, contents, emissions and labeling (eg. ban added carcinogens, heavy metals, and accurately label nicotine content and delivery). Leaking cartridges and faulty device construction have been reported.  Long-term exposure to contaminants in some e-cigarettes and e-cigarette fluid has potential to lead to adverse health effects. Recent analysis of the original evidence around the lethal dose of nicotine have suggested nicotine is not as toxic as once thought (Mayer, 2013), but it would be prudent nevertheless for refill bottles containing very high doses of nicotine to be banned or only allowed with effective child resistant packaging and containers designed to minimize inadvertent spilling, ingestion or other means of poisoning.

Other regulations that could be considered in this area are:

  • require evidence that good manufacturing practices have been followed
  • mandate reporting on the contents of e-cigarette fluids to regulators including nicotine content and typical delivery amounts
  • require labeling that provides accurate information on contents and the hazards associated with e-cigarette use.

Prohibiting e-cigarette use in places where tobacco cigarettes are prohibited: To date there has been no study confirming concerns that the use of e-cigarettes in smoke-free areas might undermine smoke-free laws. Nevertheless, to mitigate this risk it might be reasonable to require that e-cigarettes are not used in smoke-free areas. This would also address the undesirable exposure of non-smokers to additional contaminants in ambient air, even if in low concentrations. It could also be mandated that they have features to make it very obvious they are not real cigarettes (such as a LED tip that is not red or orange, or no LED tip) (Gartner et al., 2012).

Restricting the marketing and availability of e-cigarettes:  Progressive denormalization of tobacco smoking and exposure of the tobacco industry’s dishonesty and aggressive marketing tactics in many societies should help prevent adolescent uptake of both tobacco and e-cigarettes. As Etter (2013) has pointed out, if e-cigarettes protect adult smokers from smoking they will probably also protect adolescents.

It is prudent to prohibit the marketing of e-cigarettes to children and young people, as for tobacco cigarettes, and to institute controls on marketing to non-smokers (Grana, 2013). This is because questions have not yet been answered about the potential of e-cigarettes to induce dependence on e-cigarettes or act as gateway products to tobacco use in non-smokers or never-users of other tobacco products.

Abrams DB. Promise and peril of e-cigarettes: can disruptive technology make cigarettes obsolete? JAMA. 2014 Jan 8;311(2):135-6.

Andrade M, Hastings G. The marketing of e-cigarettes: a UK snapshot. BMJ Blog.

Bauld L. Commentary on Wagener et al. (2012): E-cigarettes: room for cautious optimism. Addiction. 2012 Sep;107(9):1549-50.

Caponnetto P, Campagna D, Papale G, Russo C, Polosa R. The emerging phenomenon of electronic cigarettes. Expert Rev Respir Med. 2012 Feb;6(1):63-74.

Cobb NK, Abrams DB. Commentary on Wagener et al. (2012): laissez-faire regulation: turning back the clock on the Food and Drug Administration and public health. Addiction. 2012 Sep;107(9):1552-4.

Cobb NK, Abrams DB. E-cigarette or drug-delivery device? Regulating novel nicotine products. N Engl J Med. 2011 Jul 21;365(3):193-5.

Cobb NK, Cobb CO. Regulatory challenges for refined nicotine products. Lancet Respir Med. 2013 Aug;1(6):431-3. doi: 10.1016/S2213-2600(13)70160-7.

Durmowicz EL. The impact of electronic cigarettes on the paediatric population. Tob Control. 2014 May;23 Suppl 2:ii41-ii46.

Etter JF. Commentary on Wagener et al. (2012): electronic cigarettes – the Holy Grail of nicotine replacement? Addiction. 2012 Sep;107(9):1550-2.

Etter JF. Should electronic cigarettes be as freely available as tobacco? Yes. BMJ. 2013 Jun 14;346:f3845.

Gartner CE, Hall WD, Borland R. How should we regulate smokeless tobacco products and e-cigarettes? Med J Aust. 2012 Dec 10;197(11):611-2.

Hajek P. Commentary on Wagener et al. (2012): E-cigarettes: a vulnerable promise. Addiction. 2012 Sep;107(9):1549.

Hajek P, Foulds J, Le Houezec J, Sweanor D, Yach D. Should e-cigarettes be regulated as a medicinal device? Lancet Respir Med. 2013 Aug;1(6):429-31.

Mayer B. How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century. Arch Toxicol. 2014 Jan;88(1):5-7.

O'Connor RJ. Non-cigarette tobacco products: what have we learnt and where are we headed? Tob Control. 2012 Mar;21(2):181-90.

Wagener TL, Siegel M, Borrelli B
. Electronic cigarettes: achieving a balanced perspective. Addiction. 2012 Sep;107(9):1545-8.

WHO study group on tobacco product regulation: Report on the Scientific Basis of Tobacco Product Regulation: Third Report of a WHO Study Group. In WHO Technical Report Series, no.955, Geneva: World Health Organization, 2010.

Wollscheid KA, Kremzner ME
. Electronic cigarettes: safety concerns and regulatory issues. Am J Health Syst Pharm. 2009 Oct 1;66(19):1740-2. logo