Everything wrong with the TGA interim decision on nicotine regulation
On the 2nd of February, 2017, The Therapeutic Goods Administration ruled that the current scheduling of nicotine remains appropriate, effectively keeping nicotine solutions with a 3.6 mg concentration on Schedule 7 of the Australian Poisons Standard - rendering them illegal for sale in Australia.
It is worth noting that the TGA received 71 public submission on nicotine reform with 76% of the submissions supporting the need for reform. Of the submissions making up the 76%, 35% were from consumers, 6% were from business owners or manufacturers, 2% were from peak bodies, 3% from advocacy groups, 7% from medical professionals and 1% from a consultant.
The TGA’s stance is a harmful one. In their own report, they acknowledged the immense harm reduction potential of switching from conventional carcinogenic cigarettes to e-cigarette vaping of nicotine solutions. The sale, possession and/or use of nicotine electronic cigarettes ‘is unlawful in every jurisdiction in Australia’. There are many reasons why this needs to change, covered previously by the ATA and who have jointly stated that the TGA has not acted in the interests of public health and safety by denying consumers access to life-saving vaping technology. The ATA and MyChoice have further noted how absurd it is that more harmful nicotine consumption through the carcinogenic and toxic combustion of tobacco in traditional cigarettes is legal and widely practiced even though the effects of Electronic Nicotine Delivery Systems (ENDS) are far less detrimental to the health of smokers. This claim has been backed by the Royal College of Physicians of London who have comprehensively outlined the benefits of ENDS in a 200-page report which debunked several myths used by the TGA to justify their decision to maintain the (essentially illegal) status of vaping:
E-cigarettes are not a gateway to smoking – in the UK, use of e-cigarettes is limited almost entirely to those who are already using, or have used, tobacco.
E-cigarettes do not result in the normalisation of smoking – there is no evidence that either nicotine replacement therapy (NRT) or e-cigarette use has resulted in renormalisation of smoking. None of these products has to date attracted significant use among adult never-smokers, or demonstrated evidence of any significant ‘gateway’ progression into smoking amongst young people.
E-cigarettes help smokers to quit smoking – E-cigarette smoking is likely to foster attempts to quit traditional cigarette smoking which would not otherwise have happened, a proportion of which would lead to smokers successfully quitting their habit. In this way, e-cigarettes actually act as a gateway FROM smoking.
E-cigarette vaping significantly reduces long term harm to smokers- Though there is some uncertainty about potential negative effects from long-term inhalation of the non-nicotine ingredients of e-cigarette solutions, this is likely to be very small, and substantially smaller than the ill effects of tobacco smoking. With appropriate product standards and testing to minimise exposure to the other ingredients, any health risks can be mitigated even further and this can be fostered where vape solution producers are able to sell their products off the black market and can accumulate the financial resources needed to implement improved testing and production facilities. Available data suggests that the long-term ill effects of nicotine vaping are unlikely to exceed ‘5% of those associated with smoked tobacco products and may well be substantially lower than this figure.’
The TGA should give credence to the Royal College of the Physicians by following their advice and acknowledging that whilst some regulation of ENDS is necessary to promote public safety, over-regulation encourages despondency amongst those already smoking conventional cigarettes and encourages those determined to vape to seek out black or grey market nicotine solutions, some of which contain harmful and concerning concentrations exceeding 99%. It is evident that the ‘vigorous pursuit of conventional tobacco control policies encourages more smokers to quit smoking’.
Clearly, the TGA’s decision is a prime example of the often disastrous combo of stringent bureaucracy and public health intertwining to work against sufferers of smoking addiction. Given the TGA’s record of sloppy health reform, misinformation and carelessness regarding pharmacy medicines (see their failure to address the availability of homeopathic, and in some cases toxic, teething gels for babies), their report is hard to take seriously. The TGA should have a serious rethink about their interim decision on the current scheduling of nicotine as a schedule 7 drug as well as the demonstrated benefits of obtaining ENDS for smoking cessation purposes in Australia.
For a concise summary of the 200-page report presented by the Royal College of Physicians of London, click here.
For the full text of the TGA’s decision to maintain the schedule 7 category for nicotine products of 3.6mg or more, click here.
The ATA’s report on the use of vaping technology to save lives can be downloaded from this site.
Marija Polic is a Research Associate at the Australian Taxpayers’ Alliance.