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If we fail to act now – as a matter of urgency – to enforce the regulation designed to support prescription access to e-cigarettes, we will fail to protect the health of current and future generations of Australians
IN June 2022 , the National Health and Medical Research Council (NHMRC) published an updated review of evidence that concluded people who do not smoke but use e-cigarettes are more likely to initiate smoking compared with people who neither smoke nor vape. An evidence review by the Australian National University, commissioned by the Australian Government and published in April 2022, reached the same conclusion.
The risk to health presented by e-cigarettes is not solely an increased propensity to initiate smoking. The NHMRC evidence review found e-cigarette aerosols contain dozens of chemicals known or suspected to be harmful if inhaled, causing irreversible lung damage (eg, diacetyl, acetoin and acetyl propionyl) and damage to organs with prolonged exposure (eg, manganese and nickel). Twenty chemicals, including acrolein, formaldehyde, mercury, benzene, toluene and cadmium, were detected that are harmful if inhaled and have the potential to be lethal.
Another very recent review, which did not attract the media spotlight in Australia, was conducted by the American Heart Association and assessed cardiopulmonary risks for adolescents specifically. The authors concluded that adolescents who vape, just like adolescents who smoke, are likely to have lower lung function and be particularly vulnerable to any additional lung insult, such as asthma or pneumonia. Similarly, the authors concluded that it is highly likely that adolescents who vape, just like those who smoke, will have an increased risk of cardiovascular disease in later years as a result of damage to endovascular and myocardial cells.
From October 2021, Australia adopted a prescription model for e-cigarettes containing nicotine. The approach intended to limit uptake of e-cigarettes by children and to provide a pathway for adults, with the guidance of a health professional, to use e-cigarettes as part of a structured smoking cessation attempt. The 2021 update of the Royal Australian College of General Practitioner’s smoking cessation guidelines recommend e-cigarettes containing nicotine as a “second-line therapy” for use when all other pharmacotherapies approved by the Therapeutic Goods Administration (TGA) have failed.
However, an investigation by the ABC program Four Corners (Vape Haze, which aired on 27 June 2022) showed the extent to which importers and retailers of e-cigarettes are breaking the law. In essence, e-cigarettes containing nicotine are highly accessible because individual entrepreneurs and businesses can import them with ease and retailers feel able to stock and sell them with impunity. Combine high accessibility with attractive flavours plus online marketing targeted at children, and it is little wonder children (and young adults) are getting hooked on e-cigarettes containing nicotine.
In theory, the prescription model in Australia should work like this: liquid nicotine is a schedule 4 medicine and thus e-cigarettes containing nicotine, or electronic nicotine delivery systems (ENDS), should only be imported, or sold by a domestic pharmacy, with a valid prescription. ENDS should not be available as part of a consumer market.
Fundamentally, however, the prescription model is not being enforced. The Australian Border Force is failing to stop the import of hundreds of thousands of ENDS, particularly cheap disposable devices, which are ending up in schoolyards. Retail enforcement is complicated because both jurisdictional drugs and poisons laws, which manage enforcement of schedule 4 medicines, and tobacco legislation, which manages advertising and sales of tobacco products but not schedule 4 medicines, apply to ENDS. Not all states and territories have a clear path to enforce the illegal sale of ENDS in convenience stores, petrol stations and tobacconists.
E-cigarettes that do not contain nicotine, or electronic non-nicotine delivery systems (ENNDS), confound all enforcement efforts. ENNDS are legal as a consumer product but cannot be sold to children in all states except Western Australia, where they are banned outright because they resemble a tobacco product. Because ENNDS and ENDS are identical in appearance, importers and retailers can simply claim that their products are legal ENNDS (coupled with deliberate mislabelling of the devices), not illegal ENDS, and – short of seizing and destroying the goods to test for nicotine in a laboratory – there is no way for authorities to disprove this claim.
There are multiple consequences for failing to enforce the prescription model. By far the most substantial is the increasing uptake of vaping by children and the public health tragedy that presages. Other consequences relate to minimising the known harms of e-cigarette use and maximising the potential benefits for smoking cessation.
First, the illegal consumer market undermines therapeutic use by people who might benefit from them. Second, there is no commercial incentive for an ENDS manufacturer to submit their product for approval by the TGA, which would reduce a key medico-legal concern for GPs and pharmacists. Third, none of the e-cigarettes being sold illegally meet the very minimal safety standards set out in the TGA’s therapeutic goods order (TGO 110) for prescribed “nicotine vaping products” available for sale in Australian pharmacies. The absence of child-resistant packaging combined with deliberately mislabelled ENDS is of particular concern given the risk of nicotine poisoning to children.
There is one other significant consequence of failing to enforce the prescription model as a matter of critical urgency. The longer we wait to take strong measures to prevent the sale of illegal e-cigarette products, the harder it will be for governments to resist ongoing efforts by those with commercial interests to undo the creation of healthy public policy.
All signs point to the creation and use of a “regulation impacts small business” strategy being employed deliberately (yet again) by Big Tobacco. Multiple retail associations and advocacy groups are already being funded by the tobacco industry to lobby politicians. These groups are now calling cynically for “regulation to protect children” but their idea of “regulation” is to scrap the prescription model and make ENDS available as a consumer product.
We made that mistake with cigarettes in the 1920s; we have surely learned enough to not make that mistake again in the 2020s. If we fail to act now – as a matter of urgency – to enforce the regulation designed to support prescription access to e-cigarettes, we will fail to protect the health of current and future generations of Australians.
Three steps that would simplify and strengthen enforcement to support Australia’s prescription model:
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Dr Sandro Demaio is the CEO of VicHealth. He is a medical doctor and a globally-renowned public health expert and advocate. Previously the CEO of the EAT Foundation, the science-based global platform for food systems transformation, Dr Demaio has also held the role of Medical Officer for non-communicable conditions and nutrition at the World Health Organization.
Todd Harper is the CEO of Cancer Council Victoria. Todd is a Board member and Past President of the NCD Alliance based in Geneva.
Dr Sarah White is the Director of Quit Victoria. She had been the director of communications and fundraising at the Royal Women’s Hospital in Melbourne. Prior to that, Dr White spent seven years heading communications at the Ludwig Institute for Cancer Research, an international research institute based in New York.
The statements or opinions expressed in this article reflect the views of the authors and do not necessarily represent the official policy of the AMA, the MJA or InSight+ unless so stated.
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I am 53 years old..I have been a smoker since 16 years of age. The heaviness of my smoking varied from 4-10 cigarettes per day, but could easily smoke 20 in one night having drinks.
I gave up cold Turkey at about 35 years old and then picked up the habit again at 40 because I was going through some horrible stuff.
I knew I didn’t have the will power again to stop. I’m not the person I was when I gave up last time.
Firstly when you cease smoking your metabolism slows and an average weight gain can be around 4-5 kilos but some people a lot more.
Secondly I am menopausal and the average woman going through menopause can put on around 5 kilos but some more.
Thirdly I have suffered from chronic intermittent attacks of Urtacaria for many years. Sometimes an episode will last for a few days but in the last 10 years they have been lasting for a year or more (daily). I might get a 2 or 3 month break in-between. My immunologist and GP have me on regular medications but will also put me on cortisone that Indeed whacks the weight on.
So it puts a person off knowing that certain things put on weight. I cant cease the medications because I could end up needing to use my epi pen. I cant fight mother nature and ask her to skip my menopause. Therefore smoking was staying.
I did a lot of research as I wanted a vape that had nicotine, looked like a cigarette and tasted similar. I found a company that are based in New Zealand but have a place here that supplies their products in Australia. The product needs a prescription and a Doctor contacts you once you enquire and conducts a very thorough medical history as well as obtaining information about your smoking habits. They also ask you what other measures have you used to assist in quitting. They will then make a decision on whether you are a suitable candidate for nicotine vape products. If the agree then a script is sent to you which can be used for 12 months only. After this you would need to have a review with the doctor but can contact them if you want it done earlier.
I am a Nurse and I found the process quite professional
I received my script with a nicotine mg amount that matched my cigarette smoking, sent off for my starter kit and that was in march. I have reordered refills once since then. Basically after the initial layout, its costing me around 3 dollars a day as opposed to the on average 25 dollars a day as a cigarette smoker. I still get my nicotine fix if I need it but am now smoking the vape less and less. I still feel like a real cigarette sometimes but 2 or 3 puffs on the vape and the urge goes.
Honestly I think the script is a great idea as it’s monitored by a professional and if pharmacies do get a green light then that’s great because it will be dispensed by a professional.
I am breathing better, I smell better and I don’t feel guilty or feel like an outcast anymore. I never took cigarettes to work with me anyway and are continuing the same with vapes. Strictly home or if on a night out.
Yes vapes can be harmful but no where near as much as a normal cigarette.
If it helps individuals to get off cigarettes then that’s a start. But completely agree with it being regulated and monitored efficiently
If one were to take Simon Chapman seriously, one might conclude that science had stopped advancing sometime around 1930. On the contrary science is much more advanced today than it was when cigarettes first became popular. We know much more about toxicology and have much greater insight into occupational and environmental health exposures. Using this knowledge it is perfectly possible to examine the known data around vaping (toxicology, biomarkers studies) and extrapolate the likely risks This is the basis of climate science. Scientists examine the the known data and extrapolate the likely risks of warming. If one were to argue that we should wait for definitive evidence before acting to mitigate the dangers of climate change one would be called a science denier and banished from respectable society. Unfortunately in Tobacco Control the opposite appears to be the case.
Somehow we are supposed to wait until we have definitive evidence, all the while having definitive evidence that the alternative (smoking), freely available in every supermarket around the country, kills. And will continue to kill as long as people smoke.
Somehow the argument goes, mistakes were made in the past, therefore we must not make the same mistakes. Such an argument implicitly relies on the assumption that the situation today is the same as it was in the past. It is not. But making such implicit assumptions allows those in Tobacco Control to avoid addressing or even acknowledging that the decisions made today may well have as disastrous effects (more death and disease) as the decisions made in the past.
Chapman also somehow believes that by refuting the claim that what we have now is prohibition, it therefore follows that the current restrictions that directly led to a growing problem of the black market are correct.
The black market is servicing a young adult population that are not sick and have little interest in jumping through hoops for a prescription. Further cracking down on this sets the stage (if it hasn’t already been set) for a new drug war. But apparently this is okay as long as those in Tobacco Control can claim it is not prohibition?
Dr Alex Wodak: loved his reply, and it was great to read some common sense regarding vaping. I have been vaping for almost 9 years after being a chronic smoker for many more. Tablets did not help me, therapy even less so. I am a mature woman and vaping saved my life. The problem is because it is becoming more and more difficult in Australia to obtain, seasoned cigarette smokers are looking for something to replace the poisonous ‘normal’ cigarettes’, and everyone that can manufacture a vape object wants to get on the band wagon as that is where the money is. So “smokers” don’t do their research and buy off the street or nearest street vendor and herein lies the problem as one is not aware of what they are breathing in.!
Find a reputable vaper seller, they will let you know what their product contains and issue you with a safety certificate. Do research and you will find a safe and useable vaping product that will do all it needs to do and that is supply you with a nicotine safe way to not return back to the normal cigarettes sold at vendors. This I did and I can now breathe better, have more energy than I know what to do with and I am a vaper through and through. I will never feel the need to smoke a cigarette EVER again. My lungs cleared up, I don’t cough anymore or smell really smoky, so please to those that wish to make this harder for me… stop. You have no idea what you are doing – unless you are a smoker or were before you posted your replies. If you claim children are starting to vape, then perhaps as a parent, you should slap yourself for not sitting them down and discussing options as they are taught that by their friends and misguided in making wrong choices. Cigarettes kill, vaping is saving lives.
Simon
“Nicotine vapes are of course not prohibited, any more than any prescribed drug is prohibited….”
I’m sure if you placed other dependency-forming substances like caffeine, sugar and alcohol under a prescription-only model most people would perceive this as a de-facto prohibition (and they would be correct). Nicotine in the form of NRT is sold everywhere from chemists to cancer charity donating supermarkets in a variety of kid-friendly flavours and that’s just fine.
“BakerB believes that we should not learn from that history of failed regulation”
Simon believes we should not learn from that history of failed prohibition and seemingly believes that the current booming black market has nothing whatsoever to do with the current de-facto prohibition.
“While I expect there are some who believe methadone should be sold in the way BakerB wants vapes to be sold”
Comparing tobacco harm reduction to Class A drug harm reduction is a totally dishonest straw man rhetoric. Heroine use can destroy lives and many that OD do so because of the side-effects of prohibition (varying dosages/strengths). Many THR advocates just want sensible regulations whereby the nic consumer doesn’t have to be turned into a ‘patient’ via the prescription-only model. Its no wonder the black market is swooping in to provide a ready supply as many could not be bothered making an appointment with one of the painfully few doctors that will prescribe in Australia. I’m sure that many of us would even be happy to have vaping only available through registered vaping stores. We wouldn’t have to have it available at servos, corner shops or large cancer charity donating supermarket chains either. If we wanted to be authoritarian about it we could even make it compulsory to sell THR products along side tobacco ones in tobacco shops as an incentive to switch. (an extreme idea eh?)
“There is therefore a strong argument for saying that the most common outcome of vaping is to hold people in smoking, not tip them out of it. So to hold up a mirror to BakerB’s argument, those who promote vaping are complicit in the deaths that follow.”
This is a hilarious statement that implies that vaping indirectly kills. See Cochrane review https://www.cebm.ox.ac.uk/research/electronic-cigarettes-for-smoking-cessation-cochrane-living-systematic-review-1
Its turning into Clownworld in Australia where the usual well-funded marionettes are now calling for a ban of all vaping nic or no nic.. Hardware too, because the current strict regulation isn’t enough. If this goes through the black market will be overjoyed and business will continue as usual.
I’ve been into a variety of ‘smoking areas’ in pubs and RSL happy to see many a middle-aged person vaping. Its already happening, its out there and people are using it reduce harm to themselves and I bet most of them aren’t relying on the naïve prescription-only model . This is a good thing. They are not smoking and that’s the whole point.
“we are in the infancy of knowing what the long term consequences of daily vaping will be”
This tired argument is used as a mechanism to spread fear and doubt. Nothing can come close to the chemical compounds produced from burning plant material. There’s no hope of knowing this from Australian ‘research’ as they are too hung up on ridiculous gateway, seizure, popcorn lung and EVALI claims which hold no water in the real world. If they can’t get a few simple things right how can they be trusted to present any useful information to the smoking population.
The tobacco epidemic was facilitated by historical ignorance of the health consequences of long term use of a highly addictive product. Definitive evidence of the risks of smoking was not the subject of major national reports until the early 1960s, by which time many hundreds of millions were addicted, tobacco ensconced as an ordinary item of commerce, sold alongside confectionery, bread and milk. With tobacco the product being still unregulated today in almost all nations, we are reaping the consequences of that early ignorance and the massive task of forcing the world’s most quintessential defective product to face the regulation it deserves.
“BakerB” believes that we should not learn from that history of failed regulation, and instead wave vapes through like we did with tobacco, when we are in the infancy of knowing what the long term consequences of daily vaping will be.
Nicotine vapes are of course not prohibited, any more than any prescribed drug is prohibited. Nearly every Australian uses prescribed drug(s) every year, often daily. All new drugs are scheduled and regulated, often strongly at first and then more liberally when years of monitoring of safety and effectiveness suggest this is sensible. The harm reduction drug methadone is prescribed each years to over 50,000 Australians with narcotic dependency.
While I expect there are some who believe methadone should be sold in the way BakerB wants vapes to be sold, that is an extreme position. Most think that dangerous and addictive drugs should be regulated.
So calling prescribed access to nicotine vapes “prohibition” is a totally dishonest straw man rhetoric. The most common outcomes from smokers starting to vape are that they continue to smoke and vape for many years, followed by those who abandon vaping but keep smoking. Those who completely and permanently switch to vaping are a much smaller minority. There is therefore a strong argument for saying that the most common outcome of vaping is to hold people in smoking, not tip them out of it. So to hold up a mirror to BakerB’s argument, those who promote vaping are complicit in the deaths that follow.
Evidence for the above is in chapter 5 (16,000w) of my new book Quit Smoking Methods of Mass Distraction (Sydney University Press) obtainable here https://simonchapman6.com/2022/06/22/selected-quotes-from-quit-smoking-weapons-of-mass-distraction/
The UK and Australian governments and their respective medical establishments have adopted virtually diametrically opposite appraisals and approaches to the role of vapes in the treatment and prevention of combustible tobacco addiction.
One of us must be making a catastrophic error.
1 If people who do not smoke but vape nicotine are more likely to initiate smoking compared with people who neither smoke nor vape, as these authors claim, then smoking rates would decline slower in countries with higher rates of vaping nicotine. But smoking rates are falling about 3 times faster in the UK & US, where vaping rates are higher than in Australia, where smoking rates have only been falling by 0.3% per year since 2013.
2 The toxic ingredients in cigarette smoke are far more numerous and present at much higher concentrations than in vaping aerosol. It is unscientific to simply state, as these authors have, that vaping aerosol contains toxic substances without indicating the relative risk posed by toxic substances in cigarette smoke vs vaping aerosol. The overwhelming majority of people who vape nicotine started smoking before they started vaping. The faster smoking rates decline, the faster smoking related cancers, heart and lung diseases decline. Vaping is in reality just another form of nicotine replacement therapy, albeit far more attractive to smokers and therefore far more effective. The explanation for the effectiveness of vaping in accelerating the decline in smoking rates is the combination of high uptake with high effectiveness as a quit smoking aid.
3 The prescription model for nicotine for vaping was introduced in Australia on 1 October 2021. Australia is the only western democracy to require a prescription for nicotine for vaping. Smokers are not interested. Few doctors are interested in writing prescriptions. Consequently the black market, which was already strong, has become more vigorous. Black markets have nasty adverse effects. The characteristics of the black market now were thoroughly predictable and arise directly from the unrealistic policy of trying to control a commodity for which there is strong and growing demand, with law enforcement measures which were never going to be effective. The responsibility for this failure should be accepted by advocates of this futile policy.
4 Please explain why cigarettes, responsible for the deaths of 21,000 Australians per year, are exempt from the Poison’s Standard and treated as a consumer product, while vaping, far less harmful and rarely a cause of death, is included in the Poison’s Standard? Over 80 million people now vape with vaping present in dozens of countries. Vaping started in 2006. Where are all the deaths and diseases from vaping? Smoking kills 8 million people per year worldwide.
5 Thank you for succinctly describing the very factors which made it so easy to be confident that attempted control by prescription would be futile.
6 I have followed the debate about drug policy very closely for over 35 years. My predictions may not have been popular at the time but my assessments and predictions have unfortunately been generally borne out. In spades. It is therefore sad for me to see exactly the same mistakes being made yet again but now with vaping. It is insanity to highly restrict the much safer option of vaping when deadly cigarettes are readily available for Australian adults. I was accused then of accepted funding from nefarious sources just as my colleagues and I are accused baselessly of accepting funding from tobacco companies. It is understandable that vaping adversaries would resort to smearing their opponents when their arguments are so weak.
7 Australia’s policy on vaping will be reversed just as other drug harm reduction interventions were initially opposed but eventually accepted and ultimately appreciated for the huge benefits they provide. This policy will be reversed partly because this is what happens eventually with novel drug harm reduction interventions. But also because vaping, like electric vehicles, fossil fuels, streaming, smartphones etc, is a disruptive innovation.
This is out of control!
First of all, if only Vape stores were allowed to sell ENNDS, then there wouldn’t be a massive issue around this subject- the service stations, tobacconists and little convenience stores pumping them out who are doing the damage here. As someone who relies on a vape store for employment and as an income for my family, I can assure you that it is time-consuming sourcing quality nicotine-free products, and it is infuriating that these idiots are simply whacking on a 0% label and getting away with it- when our stores dedicate a huge amount of time ordering and then waiting for shipments of actual 0% products to arrive, clear customs then be delivered to our stores. It’s so frustrating this industry gets such a bad image when we have had restrictions after restrictions imposed, and we comply entirely. Only Vape Shops Should Sell Vape Products!
Online retailers are frequently accessible to underage youth
Flavoured e-cig products are often strategically sold using flavours that appear harmless such as bubble gum or chocolate. Furthermore, these flavours can make it challenging for adolescents to comprehend the true detrimental effects of these products (1). Recently, Friedman and Warner proposed restricting the sale of flavored tobacco products to adult-only retail outlets (2). However, before policies are formulated it is important to understand how adolescents frequently access e-cig.
The rapid uptake of e-cigs in the youth population is likely attributable to ease of access to vaping products by underage youth despite existing regulatory policies and purchasing e-cigs changed markedly before and after the COVID-19 pandemic, with approximately 20% of youth e-cig users switching from retail stores to online sources (3, 4). This is consistent with emerging qualitative evidence that online retailers are frequently accessible to underage youth and that even when age verification is in place, it is often easily circumvented (4, 5). The shift toward online purchasing highlights a critical need to prohibit online sales to underage youth.
References:
(1). Huang LL, Baker HM, Meernik C, Ranney LM, Richardson A, Goldstein AO. Impact of non-menthol flavours in tobacco products on perceptions and use among youth, young adults and adults: a systematic review. Tob Control. 2017 Nov;26(6):709-719. doi: 10.1136/tobaccocontrol-2016-053196.
(2). Friedman AS, Warner KE. The E-Cigarette Flavor Debate – Promoting Adolescent and Adult Welfare. N Engl J Med. 2022 Apr 28;386(17):1581-1583. doi: 10.1056/NEJMp2119107.
(3). Gaiha SM, Lempert LK, Halpern-Felsher B. Underage youth and young adult e-cigarette use and access before and during the coronavirus disease 2019 pandemic. JAMA Netw Open. 2020;3(12):e2027572. doi:10.1001/jamanetworkopen.2020.27572
(4). Stokes AC. Declines in Electronic Cigarette Use Among US Youth in the Era of COVID-19-A Critical Opportunity to Stop Youth Vaping in Its Tracks. JAMA Netw Open. 2020;3(12):e2028221. doi:10.1001/jamanetworkopen.2020.28221
(5). Schiff SJ, Kechter A, Simpson KA, Ceasar RC, Braymiller JL, Barrington-Trimis JL. Accessing vaping products when underage: a qualitative study of young adults in Southern California. Nicotine Tob Res. 2020;ntaa221. doi:10.1093/ntr/ntaa221
It’s almost like enforceable regulation is not the same as cementing a black market through the de-facto ban (prescription model), which the respective authors lobbied for. Undermining smoking cessation did at no point require throwing teenagers under the bus.
Deterring non-smokers is as trivial as purpose disclosure / communicative medicalization (“Warning: Nicotine can be addictive. Product only meant for quitting smoking. Else waste of time & money”). But the popcorn lung and crack nicotine experts seemingly prefer less efficacious fibs, plus the gateway drug hypothesis to substitute for realistic harms.
Which begs the question, was the goal just prevention, or sustaining a call center business?
Prohibition creates a black market (what we have now) allowing dodgy vendors to sell to teens. Prohibition of life saving vaping effectively makes deadly smoking easier to access. Widespread misinformation on tobacco harm reduction puts smokers of trying it. Prohibition kills and all that support it are complicit in those deaths.
Support proper regulation (not medicalisation) of tobacco harm reduction or support smoker death. Make your choice.