‘Blood in the water’: Why the next 12 months is critical for vaping regulation

The Therapeutic Goods Administration (TGA) last month handed down an interim decision that nicotine-containing vaping products would be permitted in Australia on a streamlined prescription-only model for smoking cessation.
 
The move – in which doctors prescribe and pharmacists dispense – is aimed at stemming the flow of black market imported nicotine e-liquid, which pro-vaping group Legalise Vaping states is the main way users currently gain access.
 
‘Most users feel compelled to either import nicotine illegally without a prescription or purchase it from the unregulated black market,’ it states.
 
While e-cigarettes are legal in Australia, it is currently not possible to buy nicotine-containing e-liquid. As a result, many young people who vape have been importing the liquid from overseas – either through the TGA’s personal importation scheme, or illicitly.
 
Nicotine vaping is gaining popularity in Australia, with rates rising from 4.4% of people who smoke in 2016 to 9.7% in 2019. That rise came even as tobacco smoking rates fell to just 11% last year, down from 12.2% in 2016.
 
The recent TGA move came after staunch vaping sceptic, Federal Health Minister Greg Hunt, was forced to delay until January his proposed ban on importing nicotine for e-cigarettes after a backbencher revolt and pressure from the vaping lobby.
 
In his press release, Minister Hunt cited RACGP’s new smoking cessation guidelines as stipulating nicotine-containing e-cigarettes are ‘not first-line treatments for smoking cessation.’

A Department of Health spokesperson said that if the interim decision is finalised, it would ‘clarify that nicotine for all human use is a prescription-only medicine’.
 
‘If the interim decision is made final, a person would need a prescription for nicotine-containing e-cigarettes to be lawfully supplied to them. This would include when a person purchases the nicotine-containing e-cigarettes online from an international supplier under the personal importation scheme,’ the spokesperson said.
 
Under these changes, according to the spokesperson, Australian Customs would have ‘unequivocal powers to stop black market imports and impound and destroy them’.
 
Smoking cessation experts such as Professor Nicholas Zwar say making GPs the gatekeepers of nicotine-containing e-cigarettes may be a good compromise. But he warns the move may place new pressure on GPs, as would-be vapers would likely line up to ask for access – whether or not they are actually trying to quit traditional smoking.
 
Vaping sceptics, who believe smoking cessation is little more than a fig leaf covering an effective lobby effort to see vaping become a consumer – not medical – product, saw the TGA decision as good news. Pro-vaping advocates, meanwhile, saw the six-month delay as a win.
 
As the country grapples with the question of what to do about vaping, the opposing sides agree on only one thing:
 
The year ahead will be crucial in shaping how vaping unfolds in Australia.

A prize to be won?
  
Sceptics in public health and medicine believe the vaping industry views Australia, a linchpin of tobacco control, as a prize to be won. Emeritus Professor Simon Chapman told newsGP the vaping lobby would ‘love our scalp, so they can say even Australia is permitting it now’.
 
Doubters like Professor Chapman worry that vaping may be a stalking horse for the re-entry of tobacco companies in a more socially acceptable guise, coming after decades of successful public health work that have resulted in reduced smoking rates.  
 
Pro-vaping advocates like Dr Alex Wodak, however, say the Government’s cautious approach is preventing people who smoke from accessing a better alternative, and argue vaping is a harm-minimisation strategy given e-cigarettes are free of the tar and other cancer-causing agents in combustible tobacco.
 
So how did vaping get so politicised? What does the evidence base say? And what can Australia learn from nations where vaping has become a buzzy consumer product used by millions of teenagers as their first experience of nicotine? 


The use of e-cigarettes has become a ‘teen phenomenon’ in the US.

The RACGP earlier this year gave cautious approval to using vaping for smoking cessation, but only as a second line therapy after people who smoke had tried nicotine gum or other options to no avail.
 
That was seized on by pro-vaping advocates as approval, leading the RACGP to issue a public reproach, pointing out that the college considers it a reasonable intervention in ‘very limited circumstances’ given the long-term health consequences are unknown. 
 
‘It’s a delicate path to tread,’ Professor Zwar, who is Executive Dean of Health Sciences and Medicine at Bond University, told newsGP.
 
Professor Zwar, who still works as a GP, was the Chair of the RACGP’s Expert Advisory Group that produced the RACGP’s updated Supporting smoking cessation: A guide for health professionals, which acknowledges e-cigarettes as a potential second line therapy.
 
‘The view the expert advisory group took was that there was some evidence e-cigarettes had benefits over standard replacements supporting people to quit,’ he said.
 
‘The evidence was not extensive and not good quality, due to a lack of follow-up studies. But, nonetheless, our evidence review gave us the view that it was reasonable to offer nicotine e-cigarettes as a second line treatment for people.
 
‘That’s been influential. It’s in the TGA decision.
 
‘If that’s confirmed, it would place the decision around nicotine-containing e-cigarettes in the context of a discussion between doctors and patients. GPs and their patients need to decide whether these are a reasonable option to support smoking cessation.
 
‘But they wouldn’t be a consumer product – they’d be an aid to cessation.’ 
 
To cope with this new role, education and support for prescribing doctors will be essential, according to Professor Zwar.
 
‘There will be instances where people might come to the doctor and want it prescribed but not necessarily have the intention of using it to quit,’ he said.
 
Professor Zwar wants Australia to avoid nicotine vaping becoming a popular consumer product, as it is in the US, given the lack of knowledge of long-term health risks.
 
‘The US is the outstanding example with extensive uptake by young people. It’s a legitimate concern that use would increase if we had an approach like that, where e-cigarettes are really a consumer product that can be promoted,’ he said.
 
Professor Zwar believes the harm-reduction case advanced by vaping advocates is questionable.
 
‘Harm-reduction arguments are based on the experience in some places, like the UK. But that’s certainly not been the experience everywhere,’ Professor Zwar said. ‘Other countries show once you make it available, it’s quite difficult to regain control.’
 
For Professor Zwar, a major concern is the fact no e-cigarette or e-liquid manufacturers have gone through the process to register their product as a therapeutic good.
 
‘That, to me, says they want it to be a consumer product with much greater flexibility in how it’s used and marketed,’ he said.
 
‘We know that tobacco companies are now the major manufacturers of vaping products in Europe; they overwhelmingly dominate the market now. If they can sell e-cigarettes in countries with strong tobacco control, and tobacco in places without it, such as Indonesia, India and across Africa, that’s a win for them.’
 
Professor Zwar believes Australia should be guided by the evidence, as it has been on combustible tobacco.
 
‘We have a very strong reputation in tobacco control. We will maintain that if we are guided by evidence as to what works and try to look at that in a rational and unemotional way,’ he said.
 
‘That’s what’s been lacking in some discussion around vaping, broadly. It has become polarised and strident at times.
 
‘Our reputation will be enhanced if we stick with the evidence, build the evidence base, and then use it.’
 
The scenario Professor Zwar wants to avoid is having the floodgates open to vaping as a consumer product, only to realise in a decade’s time that there are long-term consequences.
 
‘We could look back and think, what a huge mistake. We just don’t know,’ he said.
 
‘The figure that’s often quoted, that e-cigarettes are 95% safer than combusted tobacco? That’s a group of people sitting around and coming up with the figure. That’s not data.
 
‘Sure, they must be safer than tobacco, but how much safer? And what are the long-term harms?
 
‘You have to be cautious with something with this degree of uncertainty.’
 
Recent longitudinal studies in the US suggest e-cigarettes may be no more effective than other cessation aids in helping people quit smoking. In one study of 2535 people who smoke, 13% were successful in quitting tobacco using e-cigarettes, but that result was not significantly different to other aids.
 
Two-thirds of those who quit tobacco were still using e-cigarettes two years later. 
 
The authors conclude, that these results suggest e-cigarettes may not be an effective cessation aid for adult smokers and, instead, may contribute to continuing nicotine dependence.
 
Help or harm?
Dr Colin Mendelsohn is one of the most public advocates of nicotine e-cigarettes, and a director of the Australian Tobacco Harm Reduction Alliance (ATHRA). Although he has previously distanced himself from vaping industry donations, Dr Mendelsohn last year acknowledged ATHRA had received industry funding in its inception.  
 
Dr Mendelsohn believes a prescription-only model is a ‘de-facto ban and will not work’, agreeing that the next 12 months will be a critical period for vaping in Australia.
 
‘Vaping nicotine has the potential to disrupt the cigarette market and significantly reduce smoking rates in Australia,’ he said. ‘However, excessively harsh and restrictive regulation as proposed by the [Federal] Health Minister will reduce its potential impact and lead to more smoking-related deaths.
 
‘What we need is a balanced regulatory model that makes high-quality and safe vaping products available as consumer products for adult smokers while minimising access to young people.
 
‘No other western country requires vapers to have a prescription to obtain nicotine liquids. Low concentrations of nicotine liquid are not medicines. They are a safer consumer product used to replace an existing consumer product – lethal cigarettes.’
 
Dr Mendelsohn said that although nicotine-containing e-liquid is not regulated as a medicine, consumer products are regulated by the Australian Competition and Consumer Commission, which ‘can provide strong protection to the public under consumer law’.
 
‘It should be easier to access vaping products than deadly cigarettes. It makes no sense for people to go to a doctor and a pharmacist to get nicotine liquid, when cigarettes are easily accessible,’ he said.
 
ATHRA recently surveyed 6500 Australians who vape, finding 37% would prefer to return to cigarettes or to the black market for illicit supplies.


The TGA recently decided that nicotine-containing vaping products would be permitted in Australia on a streamlined prescription-only model for smoking cessation.

On the issue of safety, Dr Mendelsohn said the key question is the relative risk of vaping versus smoking.
 
‘It is beyond reasonable doubt that the risks from vaping nicotine are much less than those of smoking, which kills up to two in three long-term users,’ he said.
 
‘Like all new products, the precise long-term health effects of vaping nicotine have yet to be established.  The [UK] Royal College of Physicians estimates the long-term risk is likely to be no more than 5% of the risk of smoking.’
 
Dr Mendelsohn argues that vaping is a ‘huge disruptive threat to the tobacco industry and is a direct competitor with tobacco sales’. He argues the slow rate of decline in smoking over the last decade – 0.3% a year since 2013 – indicates new options are needed.
 
‘The tobacco industry did not invent vaping and currently controls no more than 20% of the global vapour market,’ he said. ‘The tobacco industry began investing in vaping in 2012 in response to its own potential Kodak moment and has been trying to catch up ever since.
 
‘The primary focus should be on the improvement of public health. Safer alternatives to smoking will save lives, regardless of who manufactures them.’
 
In line with this view, a recent updated Cochrane review suggests vaping is more effective than existing nicotine-replacement therapy, with 10 out of every 100 people who smoke able to stop smoking for at least six months using nicotine e-cigarettes, compared to six per 100 using nicotine-replacement therapy.
 
‘Current smoking cessation options have very modest long-term success rates, ranging from 2–15%,’ Dr Mendelsohn said.
 
Blood in the water
By contrast, Professor Chapman, a veteran tobacco control advocate, told newsGP the recent TGA decision is a sane regulatory approach.
 
‘There’s almost unanimity around the country, with the exception of the vaping organisations,’ he told newsGP.
 
‘Does it help smokers get off smoking? The evidence is very poor for that.
 
‘If you take proper cohort studies and follow thousands of smokers, yes, some people get off it, but many more stay smoking.
 
‘Far more stay on and relapse than give up.’
 
Professor Chapman is concerned vaping – if commercialised – may prove a method to actually keep people addicted to nicotine. He is also concerned about the impact on young people, citing the example of the laissez-faire approach in the US.
 
‘When these products are available virtually over the counter, kids use these things quit a lot,’ he said.
 
Professor Chapman believes nicotine vaping will have long-term health consequences.
 
‘The average vaper pulls on one of these 200 times a day. Just follow someone around – they go at it like a steam train. It’s obviously highly addictive,’ he said.
 
‘So 200 times a day, 365 days a year for 10 years – what will the consequences be of that lung basting?’
 
‘Yes, it’s probably less dangerous than tobacco. But at the beginning of last century, 10 years after cigarettes were widely available, people said, we’re seeing no disease, so it’s okay.
 
‘We know from history what happened next. Thirty years later came emphysema, lung disease, cancer. So anyone who says we’re not seeing anyone dying, not seeing any lung cancer, it is really far, far too early to tell.’

Professor Matthew Peters is head of respiratory medicine at Concord Hospital in Sydney. He told newsGP there are ‘clear commercial interests’ currently in play around vaping.
 
‘It would be unique if a policy change to the benefit of tobacco companies was also to the benefit of public health,’ he said.
 
‘We need to be clear, Australia does not need any e-cigarettes to continue the good work in reducing smoking rates. It has been forced on us by commercial interests.
 
‘I see blood in the water over the next 12 months … to counter a strong commercial push. I hope we can achieve consensus that there is a very limited role for e-cigarettes for short-term use in a genuine cessation attempt.’
 
Professor Peters said the recent TGA decision ‘effectively repudiated’ arguments from ATHRA and other vaping advocates that nicotine-containing e-cigarettes should be a consumer product.  
 
He argues Australia should follow the European model of capping nicotine concentration at 20 mg per 1 ml in order to reduce addictiveness to new users. By contrast, the popular ‘smoking alternative’ product Juul contains 50 mg of nicotine per 1 ml.
 
Australia should only undertake small changes that can be easily reversed as new evidence comes in, Professor Peters argues.
 
‘After the explosion of tobacco use in the 1910s, it took 40–50 years before the major side effects were agreed upon,’ he said.
 
‘Do we want to make that mistake again? I don’t think so, and not for the sake of American or UK companies making a motza.’
 
Professor Peters believes the small potential benefit of nicotine-containing e-cigarettes for people trying to quit must be weighed against the risks of having a new generation get hooked on nicotine products, as the US is seeing with the teen phenomenon of Juul use.
 
‘Juul is not hard for Australian kids to get. It has high nicotine delivery, it’s easy to use and it’s easy to conceal,’ he said. ‘It’s very clear that a lot of young people have started using it in the US, which is a concerning pattern.’
 
The major area of concern for Professor Matthews is the potential for long-term health damage.
 
Vaping of cannabis oil and vitamin E acetate have led to 68 deaths and thousands of hospitalisations in the US, leading the Centers for Disease Control and Prevention (CDC) to warn about the issue.
 
‘All industries survive on new customers. If you have a high churn rate – and in smoking, that’s when people die – then you’ve got to create new users with fashionable and preferably addictive products,’ Professor Matthews said.
 
‘e-Cigarettes have become fashionable, and they are addictive. They can cause neuropsychological harms to the developing brain.’  
 
Professor Matthews argues that existing nicotine-replacement therapies have proven safety and efficacy profiles, which raises the question of why vaping is necessary.
 
‘If manufacturers of novel nicotine delivery systems believe the community benefits from the use of these products, they can put their money where their mouths are and go through the standard process [of registering as a therapeutic good],’ he said. 

Even among retailers, there is debate over whether vaping is worth fighting for.

Paul Zahra of the Australian Retailers Association moved to dissolve a spin-off organisation – the Australian Retail Vaping Association – as one of his first decisions as CEO in the middle of this year.

‘We no longer feel that is our role or an appropriate use of member resources,’ he told newsGP.

‘The vaping product line is an area that is requiring legal changes and advocating for a specific product class is not in our members’ best interest.’

Meanwhile, a different representative body, the National Retailers Association, has called the emerging pharmacy monopoly on selling vaping products ‘unfair,’ with CEO Dominique Lamb arguing the TGA decision would lock out small convenience retailers who ‘currently rely on tobacco sales for a large proportion of their income’.
 
Specific cohorts
Dr Hester Wilson, Chair of the RACGP’s Specific Interests Addiction Medicine network, told newsGP that e-cigarettes may have a role, but only for some people.
 
In her practice, Dr Wilson works with many people who are highly dependent on nicotine and at high risk of harm from tobacco.
 
‘Australia has done really well in getting smoking rates down to around 11%. They used to be 35–40%,’ she said. ‘But amongst particular groups – like those with enduring mental health issues or substance abuse – their use is anywhere from 56 to 90%. It’s very, very high prevalence.’
 
Dr Wilson sees a small role for nicotine e-cigarettes for this specific cohort.
 
‘My patients have health issues from smoking and have found it really difficult to give it up,’ she said. ‘There are complex health issues going on. There is the potential that e-cigarettes can decrease these harms.
 
‘For individuals who are highly dependent, I would assist them. But I would want that overall goal that we are using this to get to point where they can stop it long term.’
 
But that is not guaranteed.
 
‘Anecdotally, what I am seeing is that my patients who are highly dependent try e-cigarettes and end up doing a combination of both,’ Dr Wilson said.
 
Like many other health professionals, Dr Wilson is concerned about vested commercial interests wanting to sell the ‘next big thing’.   She sees a generation ‘shifting from tobacco to vaping’ in nations like the US – and sees worrying signs Australian schoolyards.
 
‘My kids already talk about the 14-year-olds vaping behind the shed,’ she said. ‘In the UK, they’ve made the product look fun, edgy and out there – I can see the same story unfolding as for cigarettes.
 
‘We just don’t know whether this is any better for a group of people. We saw this happen with smoking; the companies that marketed tobacco did their research and knew how to make people addicted.
 
‘My concern is that big business is pushing this – and succeeding.’
 
For Dr Wilson, the question boils down to this: Can she – and other GPs – decrease harms from tobacco without causing unintended harms?
 
She sees an unexpected benefit in the TGA decision to make it prescription-only.
 
‘Kids are already out there, accessing nicotine vaping. It’s something naughty, edgy, illegal,’ she said.
 
‘But what if it was boring and on-prescription? What if it was something older people did?
 
‘Would younger people still want to be part of it, if we change its reputation?’
 
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