Evidence required on the safety and effectiveness of e-cigarettes

08 September 2013

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Sunday 8 September 2013 - Results from the first study into the effectiveness of e-cigarettes as a smoking cessation aid suggest that these devices could help people to quit smoking.1 While the Australian Self Medication Industry (ASMI) welcomes the findings, more research is required.

ASMI advocates for the control of these devices as registered therapeutic goods. At the moment, insufficient data exists to determine whether e-cigarettes can be considered safe, effective and reliable smoking cessation aids. This data would be required to classify e-cigarettes as therapeutic goods and allow them to be sold alongside proven nicotine replacement therapies (NRT).

The research from the National Institute for Health Innovation at the University of Auckland was published online today in The Lancet and presented at a meeting of the European Respiratory Society Annual Congress in Barcelona, Spain. The study investigators believe the results will inform international debate and policy on the regulation and availability of e-cigarettes.

The Australian Government has previously expressed concerns about the use of e-cigarettes, as the impact of wide scale use of these devices on tobacco use is unknown, and the outcome in the community could be harmful.2 The Therapeutic Goods Administration (TGA) indicates that use of e-cigarettes may be dangerous and that there has been no assessment of their effectiveness in helping smokers quit.2 Given their unclear safety profile, e-cigarettes are not currently approved for sale in Australia.
In comparison, NRT products (like the patch tested in the study) have been rigorously assessed for efficacy and safety and have been approved by the TGA for use as aids in withdrawal from smoking.2

NRT has been the subject of hundreds of clinical trials involving thousands of patients over more than three decades and has helped millions of people to overcome their addiction to tobacco.3

According to ASMI Regulatory & Scientific Affairs Director, Steve Scarff:
"Smoking is an astonishingly hard habit to break, and successful intervention requires an integrated, multi-disciplinary approach. The use of NRT, alongside strong public education campaigns and professional counselling and support programs, has been instrumental in reducing smoking cessation levels worldwide and here in Australia.
"While the researchers from the University of Auckland have certainly added to the body of knowledge about smoking cessation aids, the overall impact of e-cigarette use on public health remains uncertain.

"While the study has been well designed and the sample size of 657 people is reasonable, it is still only one study looking at one particular e-cigarette and cartridge combination. As the authors of the study acknowledge 'there is a large number and diversity of e-cigarette products on the market, with only limited evidence available on their performance and quality'. The study therefore is only relevant to the specific combination of e-cigarette and cartridge in the trial. Other combinations will have different concentrations, different vapour characteristics and different effects on smokers."

NRT remains a front-line treatment prescribed by GPs and recommended by pharmacists for smoking cessation, a position supported by the National Prescribing Service and endorsed by the World Health Organization.

In Australia, several NRT products are available from a pharmacist or doctor to assist with quitting. Consumers can also seek advice and support from Quitline, telephone 13 7848.
Media contact: Michelle Sollitt-Davis - ASMI PR Manager
Ph: 02 9923 9410 | M: 0422 084 951 | Email: michelle@asmi.com.au

About ASMI: The Australian Self Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI's mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy. www.asmi.com.au

1. Publication to become available online at The Lancet 8 September 2013.
2. Australian Government. Department of Health & Ageing, Therapeutic Goods Administration. Electronic cigarettes. 13 March 2013. Available at http://www.tga.gov.au/consumers/ecigarettes.htm.
3. Stead LF, Perera R, Bullen C,Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD000146. DOI:10.1002/14651858.CD000146.pub3.