Australia’s Health minister Greg Hunt has deferred the introduction by six months of his decision to prohibit the personal importation of vapable nicotine and to make nicotine containing vape juice available in Australia only by doctor’s prescription. The original decision was announced on June 19 , 2020 and was to be implemented from July 1 – just 11 days later. This was always going to be far too soon to put in place the key mechanisms of the plan, and adequately advise vapers, GPs and pharmacists of the details of the scheme which are summarised here.
But Hunt’s plan has been very welcomed by everyone in public health I’ve discussed it with. Here’s why it’s a very smart and responsible move.
- Open access to tobacco has been one of the biggest disasters in public health history
When cigarette production moved from being individually hand-rolled to being made in factories by machines that today can produce some 20,000 cigarettes per minute, the price fell dramatically facilitating access by those on even the lowest of incomes. Smoking sky-rocketed in the early years of the twentieth century, pausing only in the great depression and during the two world wars because of scarcity.
As lung cancer rose to become (by far) the leading cause of cancer death (see graph below), controls on tobacco commenced. These began in the 1960s with early tepid health warnings and public awareness campaigns, from the 1970s by advertising restrictions and then bans, in the 1980s by smoke free public space legislation and tax policy, and in this century by graphic heath warnings, plain packaging and retail display bans.
But across all this time, tobacco and access to it has remained an entirely unregulated product. Unlike pharmaceuticals, food and drink which are regulated for safety and efficacy (in the case of pharmaceuticals), cigarettes and roll-you-own tobacco have always been unencumbered by any regulatory standards, for the obvious reason that they would instantly fail any imaginable test and never be allowed to be sold.
When post WWII smoking prevalence reached 60-70% of men and 30% of women, and the bad news about smoking and disease began pouring in from the 1950s, any thoughts of governments banning tobacco were entertained only by those in political cloud-cuckoo land. In a 45 year career in tobacco control, I have never until recently heard any serious person ever advocate a set date for a ban on the sale of tobacco. This essay is the most coherent and important expression of where debate on phasing out the sale of combustible tobacco sits today.
But why regulate nicotine?
2. Nicotine is regulated as a poison in Australia. It is not as “safe as coffee”
Vaping interests have long been engaged in a global effort to rehabilitate nicotine’s reputation. They are usually fine in agreeing that it is addictive, but bend over backwards to promote it as being all-but-benign – “as risky as coffee” is the usual trivialising comparison used. Many seem to regard it as having an almost vitamin-like status.
The late addiction specialist Michael Russell in 1976 that “People smoke for nicotine but they die from the tar”. This has become a talismanic mantra for vapers against nicotine regulation, rarely absent from any discussion. But in fact across the 44 years since Russell wrote those words, a large research literature has emerged on concerns about nicotine’s likely role as a cancer promoter (if you have a few hours, browse through lots of this research that I gathered together in this earlier blog), as a vasoconstrictor with major implications for cardiovascular disease , as a disruptor of cognitive development and as a possible cause of psychosis.
For these reasons, and because of nicotine’s in e-cigs strong addictive potential, Australia’s TGA continues to sensibly regulate nicotine as a poison or a therapeutic substance.
Vaping advocates are fond of arguing that because nicotine is freely available in tobacco products, it follows that nicotine for vaping should enjoy at least, if not more accessibility and be freely sold almost anywhere. This argument has all the integrity of a chocolate teapot. Cigarettes were given their unregulated commodity status at the beginning of last century, long before the evidence accumulated about two in three long term users dying from smoking. Vaping advocates insisting that e-cigs should share a regulatory playing field with cigarette accessibility seem happy to risk repeating the Sisyphean task we have faced with tobacco of trying to reduce the damage that 120 years of non-regulation has caused. It’s been 55 years since health warnings first appeared on tobacco packs and tobacco control commenced. The power of the tobacco industry has ensured that the legislative drag has nearly always been glacial.
3. We regulate and restrict access to many addictive drugs. Nicotine should not be exempted.
Every new therapeutic substance first available to consumers is regulated in all but politically chaotic nations where almost anything can be bought over the counter. Vaping advocates seem to believe their virtuous mission should exempt e-cigarettes and vapable nicotine from regulation, despite their every second sentence extolling the therapeutic virtues of vaping in cessation and harm reduction, thus catapulting it into the ambit of therapeutic regulation.
Vaping advocates messianically proclaim that vaping will save a billion lives (an estimated 1 billion smokers will die this century). This cavalier claim would require that all smokers quit or switch to e-cigs and that there are negligible health consequences of people pulling a cocktail of vapourised flavouring chemicals, nicotine and propylene glycol deep into their lungs an average of 172 times a day (62,823 times a year). Both are highly dubious propositions, to say the least.
When nicotine replacement therapy (NRT) first became available the 1980s in gum form, it was scheduled as a prescription-only drug. No one thought this was anything other than sensible and normal for a new drug. When nicotine patches, lozenges and inhaler sprays later appeared, they too were prescription-only. Over the years, as use of NRT proliferated and some ex-smokers used it for many years with only minor apparent adverse effects, NRT access was liberalized through rescheduling. The maximum doses however, have remained small through concerns about toxicity.
Drug scheduling can work the other way too. The very useful opiate, low dose codeine was available across-the-counter in Australia in a variety of pain-relieving medications until February 2018. Following accumulating evidence of abuse, it was then rescheduled to prescription-only access.
Dr Alex Wodak, an unswerving advocate for open access to nicotine vaping juice, argued recently that “Vaping is to smoking what methadone is to street heroin.” Correct. But curiously Wodak failed to note that methadone is only available via special prescription authority, dispensed at some pharmacies and clinics. In 2011, 46,446 patients were being prescribed methadone by 1,444 doctors across Australia. Greg Hunt’s plan will make nicotine vape juice available in the same way.
I’ve not aware of Wodak advocating that methadone should be available to whoever wants to buy it from any retailer wanting to sell it, in just the way that cigarettes can be sold. But if he does hold such views, good luck in selling that argument.
4. Prescribed access will greatly reduce teenage access to e-cigarettes
Smoking rates in Australian teenagers have never been lower, a phenomenon also seen in other nations like the USA, Canada and the UK which like Australia, also have had comprehensive tobacco control policies for decades. Like the tobacco industry, the business model for the vape industry (which includes all major tobacco companies) is not just about promoting its products to current adult smokers. Just as any car company which ignored young first car buyers would need its head examined, all tobacco and vaping companies are well aware of the critical role that new (read “young”) nicotine addicts have in their long term commercial prospects. 45% of US vaping retailers and 39% of English shops sell to underage customers.
Vaping advocates are usually sensitive to the reception that any expressed complacency about teenage vaping will cause, and so concentrate talk about their mission on helping smokers switch. But as the evidence about youth vaping uptake has accumulated and become undeniable, they fall back to “well, isn’t it better that they vape than smoke?”
The wider-than-Sydney-harbour-heads problem here is that many totally nicotine naïve youth are now regularly – not just experimentally – vaping. In the USA “The significant rise in e-cigarette use among both student populations has resulted in overall tobacco product use increases of 38 percent among high school students and 29 percent among middle school students between 2017 and 2018, negating declines seen in the previous few years.”
In Canada where e-cigarettes are openly accessible, there is now rising alarm at not only the rapid growth in regular vaping by young people, but in smoking rates having risen in this group for the first time in 30 years.
Longitudinal studies of e-cigarette use by teenagers have found strong evidence that, compared with those who have never vaped, later cigarette uptake is much higher in those who have (see studies from Taiwan, Italy, Scotland and USA here, here & here and a meta -analysis of 17 studies “There was strong evidence for an association between e-cigarette use among non-smokers and later smoking (OR: 4.59, 95% CI: 3.60 to 5.85)”).
These studies are routinely dismissed by vaping advocates with shallow slogans like “kids who try stuff, will try stuff” dignified by arguments about “common liability theory” or “propensity to use nicotine”. I’ve previously critiqued these often shallow arguments here and here.
With future access to vapable nicotine tied to prescription, shopping around by Medicare number traceable triggering alerts for multiple prescriptions being possibly used for on-selling to kids, and retail vape shops not allowed to sell nicotine under threat of major fines, it’s highly likely that teenage access will greatly diminish. Which is what the “official” vape industry message will of course wildly applaud …. Oh wait…
5. Banning personal imports will greatly reduce access to sub-pharmaceutical standard e-juice
When vapers or retailers import nicotine from overseas, they run risks of purchasing preparations manufactured in conditions that are far from the standards set for pharmaceutical grade drugs. This US study found bacterial and fungal endotoxins in vape juice. This study of German sourced e-juice found ethylene glycol as the dominant compound in five products. Ethylene glycol is associated with markedly enhanced toxicological hazards. The kitchen sink and bathtub amateur “labs” cooking up juice to supply the personal import trade are understandably highly anxious about Hunt’s plan.
6. The evidence of likely significant harms from vaping is mounting
The respiratory, cardiovascular and cancer harms caused by smoking rarely manifest clinically in the short term. Instead they take years to first appear as symptoms because of lagged effects. This is why they these diseases are called chronic rather than acute health problems. However, rarely a week passes when new studies or reviews of early markers for these diseases are published.
At the foot of this blog is a small selection of such recent papers in my files. You’re unlikely to find mention of these in the highlights of vaping blogs and chat rooms.
With such uncertainty about the diseases that e-cigs might reap, continuing to treat nicotine e-juice as a hands-off, unregulated commodity is recklessly irresponsible.
7. Fines for non-licensed importing are appropriate
Finally, there’s been much hysteria and melodrama about the $222,000 fines available for convictions for the illegal importation of nicotine. The fine has undoubtedly been set at that level to deter criminals from bringing in commercial quantities of nicotine. No one without an agenda seriously believes that anything but a very small fraction of that would be leveled at individuals chancing their luck by importing personal quantities. Fining importers of commercial quantities a few hundred or thousand dollars would be treated with contempt – just a small impost on the costs of doing business. Major fine possiblities will be critical in deterrence.
8. But will Australian doctors be willing to prescribe nicotine?
The elephant in the room with this scheme is the possibility that only few doctors will be interested in prescribing access to nicotine juice. At present, less than 10 doctors out of over 122,000 registered medical practitioners have apparently been doing this, with an unknown number of prescriptions being issued as a result of their actions. This hugely underwhelming participation rate may be explained by the current ability of vapers and others to easily import nicotine juice, making going to a doctor to get an authority to buy nicotine from a compounding chemist uncompetitive. When this importing ability stops in 2021, more Australian doctors may be willing to prescribe. But is possible that with nicotine continuing to have what the TGA calls “unregistered status” as a drug, that many doctors will remain uninterested. Challenging legal issues may arise in the event of an adverse reaction or health problems arising from vaping nicotine. It is conceivable that such patients may seek redress from doctors who issued the authorities for them to use such an unregistered substance.
Recent studies on harms from e-cigarettes
ECIG aerosols are harmful to living cells in vitro and in vivo.
Chung S, Baumlin N, Dennis JS, et al. Electronic cigarette vapor with nicotine causes airway mucociliary dysfunction preferentially via TRPA1 receptors. Am J Respir Crit Care Med 2019. doi: 10.1164/rccm.201811-2087OC.
Ganapathy V, Manyanga J, Brame L, et al. Electronic cigarette aerosols suppress cellular antioxidant defenses and induce significant oxidative DNA damage. PLoS One 2017;12(5):e0177780. doi: 10.1371/journal.pone.0177780.
Madison MC, Landers CT, Gu B, et a. Electronic cigarettes disrupt lung lipid homeostasis and innate immunity independent of nicotine. J Clin Invest 2019; doi: 10.1172/JCI128531. Epub 2019 Sep 4.
Raez-Villanueva S, Ma C, Kleiboer S, Holloway AC. The effects of electronic cigarette vapor on placental trophoblast cell function. Reprod Toxicol 2018;81:115-121. doi: 10.1016/j.reprotox.2018.07.084.
Shaito A, Saliba J, Husari A, et al. Electronic cigarette smoke impairs normal mesenchymal stem cell differentiation. Sci Rep 2017;7(1):14281. doi: 10.1038/s41598-017-14634-z.
Zahedi A, Phandthong R, Chaili A, Leung S, Omaiye E, Talbot P. Mitochondrial stress response in neural stem cells exposed to electronic cigarettes. iScience. 2019;16:250-269. doi: 10.1016/j.isci.2019.05.034.
Evidence for ECIG harm to users.
Antoniewicz L, Brynedal A, Hedman L, Lundbäck M, Bosson JA. Acute effects of electronic cigarette inhalation on the vasculature and the conducting airways. Cardiovasc Toxicol 2019. doi: 10.1007/s12012-019-09516-x.
Carnevale R, Sciarretta S, Violi F, et al. Acute impact of tobacco vs electronic cigarette smoking on oxidative stress and vascular function. Chest 2016;150:606-12. doi: 10.1016/j.chest.2016.04.012.
Ghosh A, Coakley RC, Mascenik T, et al. Chronic e-cigarette exposure alters the human bronchial epithelial proteome. Am J Respir Crit Care Med 2018;198(1):67-76. doi: 10.1164/rccm.201710-2033OC.
King JL, Reboussin BA, Wiseman KD, et al. Adverse symptoms users attribute to e-cigarettes: Results from a national survey of US adults. Drug Alcohol Depend 2019;196:9-13. doi: 10.1016/j.drugalcdep.2018.11.030.
Li D, Sundar IK, McIntosh S, et al. Association of smoking and electronic cigarette use with wheezing and related respiratory symptoms in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. Tob Control 2019. doi: 10.1136/tobaccocontrol-2018-054694.
Moheimani RS, Bhetraratana M, Peters KM, et al. Sympathomimetic effects of acute e-cigarette use: role of nicotine and non-nicotine constituents. J Am Heart Assoc 2017;6. doi: 10.1161/JAHA.117.006579.
Reidel B, Radicioni G, Clapp PW, et al. E-cigarette use causes a unique innate immune response in the lung, involving increased neutrophilic activation and altered mucin secretion. Am J Respir Crit Care Med 2018;197:492-501. doi: 10.1164/rccm.201708-1590OC.