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Editorials

E-cigarettes should be regulated

Martin McKee, Mike Daube and Simon Chapman
Med J Aust 2016; 204 (9): 331.
doi:
10.5694/mja16.00024

They pose many risks for tobacco control and health, and any possible benefits are few and uncertain

As reported in this issue of the MJA,1 Australia, with the world’s lowest rates of smoking among adults2 and adolescents,3 is seeing nascent, modest growth in e-cigarette use, despite having some of the strongest restrictions on their marketing and sales. Manufacturers, now including all major tobacco corporations, have spent large sums publicising their brands, using tactics that have promoted cigarettes so successfully, but boosted by the added reach of the internet. They are ahead of the regulatory curve, adopting imagery, messages and tactics prohibited in cigarette promotions, such as the sponsorship of youth events.4 They have spiced their products with a bewildering array of flavourings that in many countries would be illegal in cigarettes, and have garnered vocal support from those who see any restriction on the use of e-cigarettes by governments as a threat to individual freedom. Some aspects of these developments are, however, surprising.

The first is that, despite intensive marketing, the use of e-cigarettes in some countries now seems to be plateauing,5 suggesting that their much vaunted appeal for smokers and the talk of mass migration to e-cigarettes has been exaggerated.

The second is the naive embrace of the e-cigarette and tobacco industries by some in tobacco control. Public Health England extensively promoted a message that e-cigarettes were “95% safer” than combustible cigarettes,6 a claim based not on empirical evidence but upon a single reference to a meeting7 that was attended by researchers who were mostly known supporters of e-cigarettes, and partially funded by an organisation with links to the tobacco industry.8,9

This is despite hundreds of articles documenting the malfeasance of the tobacco industry, as recognised in the World Health Organization Framework Convention on Tobacco Control, which explicitly advises against engagement with the industry. Some of those investigating e-cigarettes are even receiving funding from tobacco manufacturers, now seeking to represent themselves as “part of the solution”10 while continuing their concerted opposition to measures effective in tobacco control.

In Australia, anyone considering importing or supplying e-cigarettes as a cessation aid must submit an application to the Therapeutic Goods Administration (TGA) with evidence of their safety and efficacy.11 The TGA then considers the evidence before determining whether the product may be sold, and, if so, under what conditions. The TGA website notes that “no assessment of electronic cigarettes has been undertaken and, therefore, the quality and safety of electronic cigarettes is not known”. Further, nicotine is, appropriately, classified as a poison except when formulated in low doses in some smoking cessation products (or when supplied in tobacco, an historical anomaly common to all countries). Recent research has identified the role of nicotine in promoting angiogenesis and thus the spread of tumours,12 and the risks it poses to adolescent brain development.13 Further, there have been several reports about the use of e-cigarette liquids in suicide attempts.14,15

These and other concerns about safety were reviewed in detail by Pisinger and Døssing16 in an article that, remarkably, was not cited in the Public Health England review of the evidence about e-cigarettes, despite being published in a leading international journal. The authors concluded that there was no such thing as a standard e-cigarette, so that studies on one brand could not be extrapolated to others. They reported that many studies have found evidence that the inhaled products contained harmful substances, some of which do not occur in tobacco smoke, while the levels of substances common to both were found to vary wildly, and in some cases were higher than in tobacco smoke.

For a product promoted by some as a game-changer in quitting smoking, it has been remarkably difficult to obtain evidence that e-cigarettes are any more effective than unassisted cessation or conventional nicotine replacement therapy.17 A Cochrane review reported the evidence as being of “low/very low quality”,18 and a recent meta-analysis concluded that they, in fact, reduced the probability of quitting.19 In these circumstances, it seems prudent to adopt the precautionary principle and to carefully monitor emerging evidence on their safety and cessation efficacy, the uptake of vaping and smoking by young people, and any further relevant developments.20

E-cigarettes have at least two distinct roles. The first is as products that may assist in smoking cessation, with possible but as yet unproven benefits that surpass those of existing methods. Second, they are a means for the tobacco industry to circumvent restrictions on promoting both their image and their tobacco products. This dual role implies the need for parallel regulatory tracks. The first involves the application of existing provisions for the authorisation, marketing (eg, claims regarding effectiveness as quitting aids) and sales of therapeutic goods. The second involves applying existing controls on all promotions that may encourage smoking, including exposure of children and young people to advertising and other forms of promotion and to any other use of smoking or tobacco-related imagery.

This twin-track approach offers a means for evaluating and maximising any potential benefits while minimising risks of harm. In the meantime, Australian governments and health authorities should not be distracted from existing approaches to reducing smoking, which are bringing such encouraging results.

Provenance: 
Commissioned; externally peer reviewed.
Martin McKee, MD, DSc1
Mike Daube, BA(Hons), HonDSci2,3
Simon Chapman, PhD, FASSA, HonFFPH3
1 ECOHOST, London School of Hygiene and Tropical Medicine, London, United Kingdom
2 Curtin University, Perth, WA
3 University of Sydney, Sydney, NSW
Correspondence: 
Competing interests: 
No relevant disclosures.
Reference Text: 
Dunlop S, Lyons C, Dessaix A, Currow D. How are smokers using e-cigarettes? Patterns of use, reasons for use and places of purchase among adult smokers and recent quitters in New South Wales. Med J Aust 2016; 204: 355-355.e7.
Reference Order: 
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Australian Institute of Health and Welfare. Tobacco smoking (NDSHS 2013 key findings) [website]. http://www.aihw.gov.au/alcohol-and-other-drugs/ndshs/2013/tobacco/ (accessed Feb 2016).
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White V, Williams T. Australian secondary school students’ use of tobacco in 2014. Melbourne: Victoria Cancer Council, 2015. http://www.nationaldrugstrategy.gov.au/internet/drugstrategy/Publishing.nsf/content/BCBF6B2C638E1202CA257ACD0020E35C/$File/Tobacco%20Report%202014.PDF (accessed Feb 2016).
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Stanford School of Medicine. Stanford Research into the impact of tobacco advertising: electronic cigarettes [website]. http://tobacco.stanford.edu/tobacco_main/main_ecigs.php (accessed Feb 2016).
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West R, Beard E, Brown J. Trends in electronic cigarette use in England [Powerpoint]. Jan 2016. http://www.smokinginengland.info/downloadfile/?type=latest-stats&src=11 (accessed Feb 2016).
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McNeill A, Brose L, Calder R, et al. E-cigarettes: an evidence update. A report commissioned by Public Health England. London: Public Health England, 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_Public_Health_England_FINAL.pdf (accessed Feb 2016).
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Nutt DJ, Phillips LD, Balfour D, et al. Estimating the harms of nicotine-containing products using the MCDA approach. Eur Addict Res 2014; 20: 218-225.
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McKee M, Capewell S. Evidence about electronic cigarettes: a foundation built on rock or sand? BMJ 2015; 351: h4863.
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Gornall J. Public Health England’s troubled trail. BMJ 2015; 351: h5826.
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World Health Organization. Tobacco industry interference with tobacco control. Geneva: WHO, 2008. http://apps.who.int/iris/bitstream/10665/83128/1/9789241597340_eng.pdf (accessed Feb 2016).
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10
Reference Text: 
Therapeutic Goods Administration. Electronic cigarettes [website]. 9 Sept 2015. https://www.tga.gov.au/community-qa/electronic-cigarettes (accessed Feb 2016).
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11
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Schaal C, Chellappan SP. Nicotine-mediated cell proliferation and tumor progression in smoking-related cancers. Mol Cancer Res 2014; 12: 14-23.
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Smith RF, McDonald CG, Bergstrom HC, et al. Adolescent nicotine induces persisting changes in development of neural connectivity. Neurosci Biobehav Rev 2015; 55: 432-443.
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Schipper EM, de Graaff LC, Koch BC, et al. A new challenge: suicide attempt using nicotine fillings for electronic cigarettes. Br J Clin Pharmacol 2014; 78: 1469-1471.
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Eberlein CK, Frieling H, Kohnlein T, et al. Suicide attempt by poisoning using nicotine liquid for use in electronic cigarettes. Am J Psychiatry 2014; 171: 891.
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Pisinger C, Døssing M. A systematic review of health effects of electronic cigarettes. Prev Med 2014; 69: 248-260.
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Brose LS, Hitchman SC, Brown J, et al. Is the use of electronic cigarettes while smoking associated with smoking cessation attempts, cessation and reduced cigarette consumption? A survey with a 1-year follow-up. Addiction 2015; 110: 1160-1168.
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McRobbie H, Bullen C, Hartmann-Boyce J, Hajek P. Electronic cigarettes for smoking cessation and reduction. Cochrane Database Syst Rev 2014; 12: CD010216.
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Kalkhoran S, Glantz SA. E-cigarettes and smoking cessation in real-world and clinical settings: a systematic review and meta-analysis. Lancet Respir Med 2016; 4: 116-128.
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Raffensperger C, Tickner J, editors. Protecting public health and the environment: implementing the precautionary principle. Washington, DC: Island Press, 1999.
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20

Re: E-cigarettes should be regulated

Add new comment (maximum 250 words)

"E-cigarettes have at least two distinct roles. The first is as products that may assist in smoking cessation, [...] Second, they are a means for the tobacco industry to circumvent restrictions on promoting both their image and their tobacco products."
These are two roles that may apply to public health officials, but less so to the public. What about the role of e-cigs for those who use them? One of their roles is certainly enjoyment and stress relief without the danger and guilt of tobacco cigarettes.
It would be nice to have access to pleasurable stress relievers like fine wine and quality food. To come home from a job that is secure, in a position that affords respect, to a comfortable home you can afford, would be great. However this is not the case for a large percentage of everyday people for whom life is an endless struggle to keep your head above water.
For the rest of us it's a beer and a cigarette in your back yard, while trying not to think about the fact that you won't have enough to pay the bills this week, your boss is a tyrant and your work is back breakingly dull. Your kid is autistic but you don't have the money for a private school with extra support. You try not to worry about what will become of him and all the things that could go wrong, and you light another cigarette because there are so few moments of pleasure in your life. In this moment at least, there is some relief.
What if your 14 year old gets caught smoking at school? Not only do you fear they will end up as addicted as you are but on top of that is the crushing guilt that you caused it by setting a bad example. Then an overwhelming feeling of powerlessness in the face of the inevitability of it all.
The stresses on low income people are many. For working class people their jobs are unsatisfying and low paid. The pleasures available to them are few and of low quality, and yet the need for them is greater due to the pressure of more complex stressors. The fear of possible health problems at some point in the future pale against the fears of today, and every day.
This is my world and I don’t feel the people who wrote this article understand me at all. They don’t speak for me, and in the case of e-cigarettes they certainly don’t appear to have my best interests in mind. As the quote above suggests, what they seem most concerned with is a war with tobacco companies and a preoccupation with making my few pleasures a medical matter.
What public health could do to help me, the public, is to give accurate information about the potential risks and benefits of e-cigarettes, especially compared to tobacco cigarettes. To allow myself, and my teenage kids, the option of a safer alternative. Despite my lack of academic credentials, I am actually capable of assessing risk and making informed choices. They may not be the choices you would make for me, but you don’t have to live my life.
Competing Interests: 
I was a smoker and am now a vaper. I work with disadvantaged people, the vast majority of whom smoke. I am a board member of the New Nicotine Alliance Au, although these are purely my own thoughts and opinions.
Jenny Stone Support Worker - Homelessness
Ruah Community Services
In the sometimes peculiar world of e-cigarette discourse, it often seems that those who recommend caution regarding their use and de-regulation are required to provide volumes of evidence that disprove their value and safety. Proponents, on the other hand, are required only to make unsubstantiated claims for the efficacy of e-cigarettes in smoking-cessation and harm reduction. As pointed out in this editorial for example, Public Health England’s widely-reported claims regarding e-cigarettes are based on extremely limited 'evidence'.

A key catchphrase of e-cigarette proponents is that people smoke for the nicotine but die from the smoke. But as noted above, there is growing evidence that suggests nicotine promotes tumours, is genotoxic, and linked to a range of cancers [1].

Ongoing uncertainty regarding the effectiveness of e-cigarettes, and their potential harm, coupled with the tobacco industry’s growing acquisition of new addictive products, provides a powerful argument against de-regulation in Australia pending further analysis.

1. Grando A. Connections of nicotine to cancer. Nature Reviews Cancer 2014; 14:419-429.
Competing Interests: 
No relevant disclosures
Ross MacKenzie PhD
Macquarie University
The primary ingredient of concern to those who wish to see e-cigarettes banned is the propylene glycol vapor, which has been studied for over 70 years.

I recently came across a document titled, “Reregistration Eligibility Decision For Propylene Glycol and Dipropylene Glycol“, which was created by the United State Environmental Protection Agency (EPA).

This quote caught my eye:

Propylene glycol and dipropylene glycol were first registered in 1950 and 1959, respectively, by the FDA for use in hospitals as air disinfectants. (page 4, paragraph 1).

I had shared the summary of research that had been done in 1942 by Dr. Robertson regarding the antibacterial properties of vaporized propylene glycol, but I had never heard that the FDA wound up approving it for the purpose of an air disinfectant in hospitals.

Indoor Non-Food: Propylene glycol is used on the following use sites: air treatment (eating establishments, hospital, commercial, institutional, household, bathroom, transportational facilities); medical premises and equipment, commercial, institutional and industrial premises and equipment; (page 6, paragraph 2)

Method and Rates of Application


Air Sanitizer

Read the directions included with the automatic dispenser for proper installation of unit and refill. Remove cap from aerosol can and place in a sequential aerosol dispenser which automatically releases a metered amount every 15 minutes. One unit should treat 6000 ft of closed air space… For regular, non-metered applications, spray room until a light fog forms. To sanitize the air, spray 6 to 8 seconds in an average size room (10'x10'). (page 6, paragraph 6)

My point here is we were all born in a hospital that uses basically ecig juice to disinfect the atmosphere and everywhere else we've been since birth! Why the attacks.

On Second hand smoke;

The Chemistry of Secondary Smoke About 94% of secondary smoke is composed of water vapor and ordinary air with a slight excess of carbon dioxide. Another 3 % is carbon monoxide. The last 3 % contains the rest of the 4,000 or so chemicals supposedly to be found in smoke… but found, obviously, in very small quantities if at all.This is because most of the assumed chemicals have never actually been found in secondhand smoke. (1989 Report of the Surgeon General p. 80). Most of these chemicals can only be found in quantities measured in nanograms, picograms and femtograms. Many cannot even be detected in these amounts: their presence is simply theorized rather than measured.

Competing Interests: 
No relevant disclosures
Daniel Hammond research assistant
Boston Medical