Experts are at odds with the Therapeutic Goods Administration’s new rules around the importation of vaping products.

My father looks older than he probably should for a man in his late 50s. His hair is grey. His hands are wrinkly and tough. His usual attire, as it has been since I can remember, consists of a wife beater and board shorts, unusual for someone with two degrees. But where there would usually be a cigarette cradled between his yellow-stained fingers is now, instead, a vaporiser resting in his palm.

Although he made the switch several years ago, the damage had already been done. Last year, he was told he had to have a small part of his tongue cut out due to a cancerous lump that formed as a result of years of smoking cigarettes.

After a successful operation my father is in good health and can continue vaping but come October later this year, a future free from cigarettes may be uncertain.

Changes to the Therapeutic Good Administration’s rules about the importation of nicotine e-cigarettes and liquid nicotine without a prescription could sway my father and other ex-smokers to take up cigarettes again.

Because vaporisers have been deemed a therapeutic good, vaporisers and their associated products are now under the remit of the TGA which can make regulatory decisions on products independently from the government.

Announced in December, the new regulations, which come into effect in October, ban the importation of vaporisers and the nicotine e-liquids used to refill the device without a doctor’s prescription Australia-wide. This brings the federal importation law, into line with state and territory laws about the sale of these devices and nicotine e-liquids within Australia.

A new hope ?

The modern e-cigarettes or vaporisers, as they are now more commonly known, first came on to the market in 2003. This first generation vaporisers were expensive, niche items, gimmicks.

Emeritus Professor Wayne Hall from the University of Queensland has studied vaporisers since their adoption in the early 2000s and has published papers on vaping in the International Journal of Drug Policy and the Nicotine & Tobacco Research journal among many others.

“E-cigarettes first appeared here in about 2006. But they didn’t really take off until much later. Local regulators pre-emptively banned them by classifying products that contain nicotine in fluid form as a poison,” he says.

The vaporiser, now in its fourth generation, has been much improved causing a surge in popularity. It is now recognised as a potentially better Nicotine Replacement Therapy than more traditional NRTs such as patches, sprays and gum.

Research led by Professor Neal Benowitz from the University of California published in Trends in Cardiovascular Medicine in 2016 found “cardiovascular risks of nicotine from e-cigarette use in people without CVD [cardiovascular disease] are quite low.” But CVD is only one smoking related health effect.

“We came to the view that there is some evidence, and it’s emerging and more studies are needed, that nicotine e-cigarettes may be as effective, or possibly more effective, than standard NRTs.”

Professor Nick Zwar

Professor Nick Zwar, Executive Dean of the Faculty of Health Sciences and Medicine at Bond University, doesn’t see the issue as black and white. A former GP and now Chair of the Royal Australian College of General Practitioners, Zwar is in the expert advisory group that writes the college’s smoking cessation guidelines.

“There weren’t a large number of studies and the quality of the studies varied. And the length of follow up varied. But there was some evidence that e-cigarettes containing nicotine were more effective than standard NRT’s in that meta-analysis,” he says.

During his research with the advisory group, he found some promising evidence of the efficacy of e-cigarettes as a Nicotine Replacement Therapy to help long term smokers break the habit of smoking without the sudden shock of nicotine withdrawal.

“We came to the view that there is some evidence and it’s emerging and more studies are needed, that nicotine e-cigarettes may be as effective or possibly more effective than standard NRTs.”

Another reason that ex-smokers like vaporisers is that with cigarette taxes continuing to rise, vaporisers have become a cheaper alternative to cigarettes.

According to the Australian Tobacco Harm Reduction Association an average pack a day smoker will spend $10,580 a year on cigarettes, while a comparatively aggressive vaper will spend just $1150 a year on e-liquid.

Australia has taken a cautious approach to supporting e-cigarette use while health departments from various countries around the world are encouraging the use of vaporisers as a smoking cessation device, most notably by the National Health Service in the United Kingdom.

“Here in Australia most people in the public health tobacco control community are very supportive of Australian policy,” Hall says.

Although the TGA regulations could potentially make it harder for vapers to access e-liquid, the fact that it has been categorised as a therapeutic good means that the TGA understands that people use vaporisers as a tool to quit smoking.

Zwar says Australia’s decision to make vaping products available to people with a prescription, even though they are not approved medicines, is unique around the world.

The government strikes back

The main reason for the new ban on importation of vaporisers and e-liquid comes after research from the US led by Richard Miech from the University of Michigan, published in The New England Journal of Medicine in 2019, concluded teens who have vaped are three times more likely to have smoked cigarettes.

But the claim that vaping is a gateway for youth smoking is debated. A report from the NHS found that teens who have already smoked cigarettes are the group most likely to vape, while teens who have never smoked are unlikely to pick up a vaporiser.

“If vaping was a major gateway into smoking, you’d expect to see a rising figure of smoking, following on from the increase in vaping and we just haven’t seen that so far.”

Professor Wayne Hall

Hall is skeptical of the conclusions drawn from the findings of the research from the US because, in his experience, young people experiment with a wide variety of substances and vaping nicotine just happens to be one of them.

“The other reason for being skeptical about the ‘gateway’ is that the prevalence of cigarette smoking amongst young people has continued to decline, both in the US and in the UK, despite the fact that there’s been quite a bit of uptake of vaping amongst young people in both countries,” he says.

“If vaping was a major gateway into smoking, you’d expect to see a rising figure of smoking, following on from the increase in vaping and we just haven’t seen that so far.”

Both Hall and Zwar both acknowledge although the research in support of e-cigarettes is promising, there is not enough of it to determine the long-term health effects of vaping.

“Now, in terms of nicotine vaping we do not know what the long-term harms of that are. Because they just haven’t been around long enough to know. The short-term evidence is reassuring in the studies that have been done, but the long-term data just isn’t there,” Zwar says.

Return of the cigarette?

Even though there is a consensus on the disastrous health consequences of cigarette smoking, there are still conflicting views on whether nicotine itself is carcinogenic.

“A very famous British tobacco researcher Michael Russell summed it up as ‘People smoke for nicotine but they die from the tar’,” Zwar says.

Similarly, other substances found in e-liquid, such as vitamin E acetate, can be extremely risky. The e-liquid containing vitamin E acetate was strongly linked to over 2800 hospitalisations and 68 deaths in the US in 2019.

“Vaping can be very dangerous, but it depends what you’re vaping,” Zwar says.

“In terms of nicotine vaping, we do not know what the long term harms of that are.”

Zwar says although nicotine isn’t considered carcinogenic in humans, there is evidence it is harmful in other ways.

“There’s some evidence in animals, that if you’ve got an existing tumor, that nicotine may increase the blood supply to that tumor. So there’s a theoretical concern that it may enhance carcinogenesis.”

This is supported by research led by Dr Pankaj Chaturvedi published by Indian Journal of Medical and Pediatric Oncology in 2015 that found nicotine “promotes tumorigenesis” and “adversely affects many organs.”

“Also if you take an overdose, it can cause death,” Zwar says.

“I don’t see it as an inevitability by any means that people if they can no longer get access to their vaping products that they’ll go back to smoking.”

Professor Nick Zwar

“One of the concerns with nicotine vaping products is making sure that a child can’t swallow the nicotine liquid, because that can be deadly and there have been instances of that.

“So it’s not certainly not harmless but it’s not the thing that that causes the the harm from from tobacco smoking in the sense of the cancers and the heart diseases.”

But cancer isn’t the only concern when it comes to nicotine.

Research led by Dr Tobore Onojighofia published by Journal of Adolescence in 2019 has shown that oxidative stress brought on by E-cigarette use could potentially play a role in developing negative social outcomes for teens including “poor learning and academic performance, increased aggressive and impulsive behaviour, poor sleep quality, attention deficits, impaired memory, and cognition, and increased depression and suicidal ideation.”

“Clearly, we wouldn’t be wanting these products to be promoted widely, particularly to young people who aren’t using cigarettes and aren’t using nicotine because clearly these products are potentially addictive,” Hall says.

The TGA states on its website the rule changes balance the need to restrict vaping products from teens while still allowing vapers to access vaping products for smoking cessation on their doctor’s advice, but Hall claims the TGA’s categorisation of vaporisers as a therapeutic good will make vaping products harder for ex-smokers to access.

“It should be regulated less stringently than a medical product because that effectively bans it. If you insist on the usual standard of proof of efficacy and safety that’s required to approve a pharmaceutical, then none of these products are going to get out,” he says. 

Zwar believes the availability of other NRTs will help any ex-smokers from returning to cigarettes.

“I don’t see it as an inevitability by any means that people if they can no longer get access to their vaping products that they’ll go back to smoking,” he says.