Ban on nicotine e-cigarettes will cost thousands of lives

Posted by DrMendelsohn on 4 February, 2017

The medicines regulator, Therapeutic Goods Administration (TGA) rejected a golden opportunity this week to save the lives of hundreds of thousands of Australian smokers by failing to remove the ban on nicotine for use in electronic cigarettes. Australian smokers are being denied access to a life-saving technology which has helped millions of smokers to quit overseas.

The TGA blocked an application for low concentrations of nicotine to be used in e-cigarettes as a safer alternative to smoking. For those who are unable to quit smoking, switching to an e-cigarette is a much less harmful and cheaper substitute.

The decision leaves Australia out of step with the United Kingdom, European Union, United States, Canada and New Zealand where e-cigarettes are legal and available or are in the process of being legalised.

How has the TGA got it so wrong?

The TGA’s decision is based on several premises which are not supported by evidence.

Firstly, there is the concern that e-cigarettes may increase the uptake of smoking by young people (the ‘gateway effect’). However, 10 years of experience in the UK, US and Europe suggests that the opposite is true — that e-cigarettes may be diverting adolescents away from smoking.

A recent comprehensive review from Canada concluded that ‘fears of a gateway effect are unjustified and overblown’ and that ‘vaping is replacing—rather than encouraging—the smoking of tobacco cigarettes among young people.’ Independent reviews from the UK agree with this finding (here and here). It is obviously better for young people not to use e-cigarettes, but vaping is preferable to smoking and is at least 95 per cent safer.

The clear evidence from international experience is that most e-cigarette use by young people is experimental and short-lived and regular use by non-smoking adolescents is rare. Progression to smoking is even rarer. In fact, many young smokers use e-cigarettes to help them quit and the great majority do not use nicotine.

It is therefore no surprise that smoking rates in young people are falling rapidly in countries where e-cigarettes are available. In the US for example, the rate of decline in smoking over the last 4 years is the fastest on record.

Secondly, the TGA highlights the fear that e-cigarettes will ‘renormalise’ smoking and undermine the success of tobacco control, leading to higher smoking rates. In fact, overseas evidence suggests quite the opposite. According to Public Health England, ‘There is no evidence that e-cigarettes are undermining the long-term decline in cigarette smoking among adults and youth, and may in fact be contributing to it.’

Thirdly, concerns are raised about the long-term safety of nicotine and of poisoning risks from nicotine liquid. Although it is the main addictive chemical in tobacco, long-term use of nicotine is regarded as low risk (except in pregnancy), based on over 50 years of snus use (moist, oral tobacco used in Sweden) and over 30 years of nicotine replacement therapy, such as nicotine patches. Nicotine is not the harmful ingredient in tobacco. It does not cause cancer or lung disease and has only minor effects on the cardiovascular system.

According to Public Health England, the risk of poisoning from ingestion of nicotine e-liquids is similar to other potentially poisonous household substances. Even in overdose, the risk of harm from nicotine e-liquids is small. Most cases result in prompt vomiting and serious outcomes are rare.

What is the overall risk from nicotine?

Any risk assessment is meaningless unless it considers the benefits as well. The TGA appears to have overlooked the huge public health gains from vaping. Cigarettes are the most lethal consumer product ever invented and kill two out of three Australian smokers. It seems reasonable to tolerate a small amount of risk and uncertainty when such devastating harm can be prevented. In the European Union alone it is estimated that over 6 million smokers had quit smoking using e-cigarettes by 2014.

E-cigarettes are not harmless. Nothing is. However, as regular e-cigarette use is almost exclusively confined to smokers, the risks from e-cigarettes should only be assessed in comparison with the risks of smoking. Even the most ardent opponents of vaping admit that e-cigarettes are substantially safer.

The TGA is locked in a time warp and its report is based on fear and misinformation rather than the available science. It focusses on small but exaggerated risks and ignores the huge public health opportunity.

By denying smokers access to a much safer product, its decision supports the tobacco industry. Australian smokers will pay the price for this misguided analysis.

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