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THE regulation of vaping products that contain nicotine (nicotine vaping products [NVPs]), differs markedly between Australia and other similar countries (the United Kingdom, New Zealand, the United States, Canada), where NVPs are sold as consumer goods so people can buy them to use as a lower risk alternative to cigarettes or a smoking cessation aid.
In contrast, Australia currently regulates NVPs as a prescription medicine (Schedule 4) for therapeutic use, or a dangerous poison (Schedule 7) for non-therapeutic use. However, the TGA recently announced an interim decision to expand the Schedule 4 entry to include all human use (not just therapeutic use).
This scheduling decision clears up confusion about whether nicotine vaping products should be classed as dangerous poisons or as prescription medicines, and should lead to more consistent regulation of NVPs by state and territory health departments across Australia.
The proposed date for this scheduling change is 1 June 2021. However, the Delegate indicated that an earlier implementation date may be considered if professional standards and clinical guidelines concerning NVPs become available sooner.
The Royal Australian College of General Practitioners (RACGP) smoking cessation guidelines states that NVPs “may be a reasonable intervention to recommend” to “people who have tried to achieve smoking cessation with approved pharmacotherapies but failed, and who are still motivated to quit smoking and have brought up e-cigarette usage with their healthcare practitioner”.
The RACGP guidelines also list several provisos to the recommendation, namely:
- Long term health effects are unknown;
- no tested and approved e-cigarette products are currently available;
- possession of nicotine-containing e-liquid without a prescription is illegal;
- only short term use should be recommended; and,
- dual use (ie, with continued tobacco smoking) should be avoided.
As there are no NVPs listed on the Australian Register of Therapeutic Goods, Australians can only legally access NVPs via one of the exemption pathways for accessing unapproved therapeutic goods with a medical prescription. These are personal importation, the Special Access Scheme (SAS), the Authorised Prescriber Scheme (APS) and extemporaneous compounding.
On 19 June 2020, the Australian Government announced it would remove the personal importation option from 1 July 2020. After this date, all imports of nicotine vaping liquid would require a permit from the Office of Drug Control. The prohibition would be imposed for 12 months while there is public consultation on a proposal being considered by a Ministerial advisory committee to regulate all NVPs designed for human use (not just human therapeutic use) as a prescription medicine.
After backbench Members of Parliament objected to the proposed ban on personal importation, the federal Health Minister announced that its introduction would be delayed until 1 January 2021 in order to allow consumers and health professionals to prepare for the policy change and create a streamlined process for patients to obtain prescriptions through their GP.
If the proposed changes proceed, a reliable supply chain for NVPs will be needed. The supply of medicinal cannabis in Australia may provide such a model. As of August 2020, there were at least 32 authorised manufacturers and 29 authorised importers for medicinal cannabis products in Australia. Some of these companies facilitate supply by connecting patients to doctors and pharmacists via their websites. Similarly, licensed importers of NVPs could supply a network of pharmacies and medical practitioners via the SAS and APS pathways with products that meet an agreed standard. Alternatively, they could provide nicotine for extemporaneous compounding into liquid that can be used in a vaping device.
It is uncertain whether a reliable prescription and supply network will be in place before the proposed ban on personal importation commences. For example, it is unclear how many Australian medical practitioners are willing to (i) prescribe NVPs as an unapproved therapeutic good and (ii) organise supply via the SAS, APS and compounding pathways. Similarly, we do not know how many pharmacies are willing to compound NVPs or to supply imported NVPs via the SAS or APS pathways. Moreover, a standard for NVPs will need to be developed and approved along the lines of the standards developed for medicinal cannabis.
More broadly, it is unclear whether this approach will be acceptable to people who smoke or vape. It may not be acceptable to those people who reject a medical approach to smoking cessation because they do not believe that smoking is a “disease”. Removing the personal importation pathway will reduce consumer choice by restricting the range of products that are available. Furthermore, NVPs acquired via the SAS, APS or compounding routes may cost more than continuing to purchase cigarettes. If these legal pathways are not acceptable and affordable to potential consumers, they will either resort to illicit sources for NVPs or return to smoking cigarettes.
By contrast, tobacco cigarettes will continue to be regulated as a consumer product that is readily available for purchase from a wide range of outlets, such as supermarkets, convenience stores and petrol stations. The greater barriers to accessing NVPs than cigarettes are a strong disincentive to switching from cigarettes to NVPs.
The restrictions on access to NVPs should raise serious questions about why Australia minimally regulates sales of tobacco cigarettes, which contribute to the premature deaths of 21 000 Australians each year. The elimination of cigarette smoking will require a planned approach that comprehensively regulates all tobacco and nicotine products with consideration of the spectrum of harmfulness of nicotine delivery systems.
Research is urgently needed on more restrictive models of access to tobacco cigarettes and on the optimal way to enable people who may benefit from access to NVPs and avoids the promotion of NVPs to young people who do not smoke tobacco.
Associate Professor Coral Gartner, University of Queensland, Faculty of Medicine, School of Public Health.
Professor Wayne Hall, University of Queensland, Faculty of Health and Behavioural Sciences, National Centre for Youth Substance Use Research.
Associate Professor Kathryn Steadman, University of Queensland, Faculty of Health and Behavioural Sciences, School of Pharmacy.
The statements or opinions expressed in this article reflect the views of the authors and do not represent the official policy of the AMA, the MJA or InSight+ unless so stated.
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We all need to commend the Australian governments’ timelyand sensible initiative. Recently, the FDA commissioner recommended banning e-cigarettesuntil we find a vaccine to fight the deadly SARS-CoV-2. Meanwhile, the AmericanFamily Medicine Association, and the Canadian Pediatric Association also appealed for the same. Short term and long-term,direct health risks caused by using e-cigarettes are apparent and also we needto understand that nicotine is highly addictive. Moreover, of greatconcern, recent findings have suggested that e-cigarette exposure increases riskof getting SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). Moreover,the dual users, (those who regularly use vaping and smoking combustiblecigarettes together) in the last 30 days are nearly seven times more likelythan non-users to be diagnosed with SARS-CoV-2, and almost five times morelikely to experience symptoms. This study also clearly shows vapers are posinghigh stress on SARS-CoV-2 testing resources (1). Therefore, if we couldpotentially reduce the number of vapers, we will reduce the unnecessary stresswe are putting on our testing system. Clinicians should support the cessationof e-cigarette use, considering the current SARS-CoV-2 pandemic.
REFERENCE:(1). Gaiha SM, Cheng J, Halpern-Felsher B. AssociationBetween Youth Smoking, Electronic Cigarette Use, and COVID-19. J AdolescHealth. 2020 Oct;67(4):519-523. doi: 10.1016/j.jadohealth.2020.07.002. Epub2020 Aug 11. PMID: 32798097; PMCID: PMC7417895.
With the only potential for serious harm coming from the flavourings there is little need for anything other than light touch regulation. Set against this is the massive damage caused by combustible tobacco use. It is a no brainer.
End off.
Vaping is one form of nicotine addiction harm reduction. Heated tobacco is another form of nicotine harm reduction. What do readers think of this method of consuming nicotine? Should it be under the same level of restrictions and availability is vaping?I look forward to colleagues’ responses.
In the end you either support tobacco harm reduction to save lives or lobby against it making it harder to access than more deadly delivery systems (combustible tobacco) and kill smokers.
Sensible Legislation and Regulation is essential, no question. However vaping has been around now for well over a decade and the majority of the science carried out shows that it is far less harmful than combustible tobacco products. Yes it is more harmful than fresh air, but for existing smokers it is a god send for giving up smoking and weaning off nicotine.
No one is suggesting that it should be available to minors and the vast majority of vapers that I have spoken to would strongly advise non-smokers (never smokers) to steer clear and not take up vaping. I admin a Facebook vaping page with one thousand members. One thousand success stories.
I smoked for over forty years and tried ALL of the traditional products and methods to give up. Multiple times. Nothing worked. Someone put a vape in my hand and I gave up OVERNIGHT. I have now been cigarette free for over three and a half years and have gone. From 12mg nicotine down to 3mg. I will be nicotine free by the New Year.
My doctor is so impressed with my health improvement that he is now recommending it to other patients of his that are long term smokers.
Vaping works. Vaping saves lives.
More than 520 thousand Australians now vape and are actively reducing the statistics of more than 20 thousand Australians that die of tobacco related disease each and every year.
Rest assured that we have done our research (exhaustively) and KNOW that vaping has given us a way out and saved our lives.
Unfortunately the Government still values the $18bn in tobacco tax revenue it collects each year more than Australian lives.
It makes no sense to regulate Vaping any tighter than cigarettes. Vaping is 95% safer and provides a real alternative for those wanting to quit smoking.
In the 1970s UK Professor Michael Russell noted that “people smoke for the nicotine but die from the tar”. So now half a century later we have technology that can provide nicotine without the dangerous toxicants of tobacco combustion. Comparison of chemicals in vaping aerosol vs cigarette smoke and biomarkers in bodily fluids of vapers vs smokers shows far fewer chemicals, fewer dangerous chemicals and at much lower concentration associated with vaping rather than smoking. Smokers who have switched to vaping often report that their symptoms have decreased or disappeared while physiological tests also generally improve. Australia’s Poisons Standard includes nicotine for vaping but explicitly excludes nicotine in cigarettes although 21,000 Australians die each year of a smoking related condition. Australia is the only western democracy to treat vaping in this hostile manner. Consequently cigarettes, which will result in the death of up to two out of every three long term smokers, are readily available from 20,000 outlets in Australia while vaping is highly restricted and the Health Minister plans to make vaping even more restricted. Initiation of smoking among Australian teenagers is already at very low levels. Our problem is that too few older smokers are quitting. Australia’s smoking rat since 2013 has only been dropping at 0.3% per annum compared to 1.0% per annum in the US and 0.8% in the UK. The decline in smoking rates accelerated in the US and UK accelerated after vaping became more popular. Unfortunately Australia fiercely resists this relatively new form of drug harm reduction just as methadone treatment, needle syringe programs, drug consumption rooms and other new forms of drug harm reduction were also vigorously opposed for some years after their introduction. But the public opposition of 28 government backbenchers to the proposed new restrictions on nicotine for vaping suggests that political change is on the way. Hunt’s proposed policy is wrong and unworkable.
We know a lot more about the long term health improvement potential of vaping, thanks to prior science learnings and modern computer modeling. than the so called experts would have you believe. 17 years of main stream use of ex-smoking, Pharmacist/electronics enthusiast Hon Lik’s Invention, has also shown no serious health issues in humans, which is greatly more research than any product released has ever had. 50 million current users world wide, with little government help and practically zero public funding, have researched and happily embraced vaping with 2.5 times the success rate for quitting cigarettes compared to traditional NRT, despite the lack of support and encouragement from government and NGO organizations, with the exception of the UK and now NZ which actively promote vaping as tobacco harm reduction, with sensible non prescription regulation, helping to successfully dissuade young people taking up vaping. Alcohol and Tobacco and other adult products, voting, marriage, military service are all successfully regulated with 18+ years regulation, which has been missing from vape products to date, except in locations such as UK & EU which haven’t had the minimal and statistically misrepresented underage use problems as seen in the until recently under regulated USA. Vaping should be as widely available as cigarettes to encourage smokers to switch. Smoking decline rates have flatlined in Australia over recent years, whilst legal vaping has shown much faster smoking declines in the rest of the world (youth & adult). 21,000 Australians a year loose 10 to 15 life years or more to smoking, if we wait another 40 years for research to show the minimal health effects of vaping which has be predicted from current data, another million of our family and mates will suffer and die unnecessarily. (1 Billion people this Century in the world). The interests of tax revenue(150% of countries total Medicare bill from 15% smoking population $12Bn/$18Bn), public health funding from tobacco taxes, reduced pension spending, pharmaceutical NRT profits and health charity dependence on funding from such, health industry profits from sick smokers and billionaire philanthropist’s self interests in removing the existing small business which pioneered this sector (so their big tobacco / big vape can replace them) must not be the deciding factors in a responsible outcome for smoking tobacco harm reduction.
It’s a myth to claim that there’s growing evidence of youth vaping. Looking at the latest data’s in the USA smoking and vaping is at it lowest <1% and Professor Aranda is talking about an epidemic, what epidemic? The epidemic never existed except in some anti-vaping heads not in the USA not even elsewhere, purely mythical illusion. No data’s support these claims.
A fact is spreading no data based claims and making irresponsible claims about vaping that is more than 20 times safer than smoking.
Saying we know almost nothing about the long term impact is absurd and closing eyes and ears to science. If there is no lethal from the beginning, why should there suddenly appear a deadly outcome. Nicotine vaping should be used for what it is invented for, namely quitting smoking tobacco cigarettes that are extremely dangerous to health.
Nobody from the harm reduction side has and never will claim “safety and harmlessness” only anti vaping ppl do that!
A regulation is by actual laws not necessary and it’s intended solely for adults anyway. The approach to take is to show and explain to every Australian smoker that vaping is a worldwide proven product to reduce harm. If Australia wants fewer smokers than promote nicotine vaping and the success rate will be unique and measurable.
I simply do not understand the whole attention that vaping has in Australia?
It has been around for over 10 years now.
All the negativity comes from the US and only from the US ( ask yourself why) with paid studies ,debunked and retracted researches.
The media likes the scare mongering because it sells.
In the rest of the developed world has become a part of everyday Life, the goverments tax it accordingly , people make the switch, vaping saves lifes
This status quo suits only the tobacco industry in Australia and the governments 17..5 bil. $ a year in tax revenue.
As a smoker of 35 years and vaper of 6, vaping saved me.
Implement the NZ, Canada or UK model give the vape shops licences and certificates to sell nicotine juice, and keep everything else as it is.
There really is no need to convert Chemists into Vape shops.
People seem to think that vaping nicotine is as unhealthy as smoking tobacco. From my own experience, it is not. We should be pushing smokers to nicotine vaping to help reduce the harm that tobacco smoking does. I can personally attest that nicotine via vaping is not as addictive as nicotine via tobacco – I went through moderate withdrawal symptoms as I quit smoking and started vaping nicotine and I still even after 3 years have the occasional urge to have a smoke (I don’t have a smoke though).
I know this might be a unpopular opinion but nicotine by its self is not the villain here, it even has positive therapeutic value once it is separated from tobacco (google “Parkinson’s Disease nicotine” for starters). It appears to be no more dangerous to you than caffeine is – they are both a stimulant at lower doses and poisonous at higher doses. The real issue is how you get the nicotine, burning/burnt biological matter is not good for you at all and that doesn’t even consider the extra additives that tobacco companies add to make nicotine more addictive to make you not want to stop inhaling all that burnt biological matter.
Is a vaporised mixture of propyl glycol and glycerine bad for you in the long run (remember that vaping does not involve combustion)? We don’t know either way but we do know that in the short and medium term it is a heck of a lot safer than inhaling burnt tobacco.
On the face of it, the argument makes sense. However, the cane toad analogy is instructive. The cane toad was brought in to eat a specific beetle to save sugar plantations. The cane toad went on to be far more problematic than the beetle! Why introduce something that could be problematic in the future, when we’re succeeding in getting smoking down without them.
The availability of combustible cigarettes is a legacy of the long delay between their availability and knowledge about their lethal impact. Given we know almost nothing about the long term impact of novel nicotine delivery systems and the rapid evolution of the products – compounds and devices – making the generation of science difficult. We also have clear and concerning early warning signs that claims of safety and harmlessness are unfounded thus I am fully supportive of the need for regulation. Harm minimisation might be true for heavy addicted smokers but it is not true for our youth and Australia must avoid the growing epidemic of youth vaping (nicotine and beyond) being seen in other countries.
The answer to the above question depends on the regulations relating to cigarette smoking.
If there was prohibition or strict regulation on availability of cigarettes, then I would agree that similar prohibitions be applied to both cigarettes and NVPs. In this event it would make no sense to have different regulations relating to the availability of NVP’s and cigarettes.
But as the minimal restrictions on the supply of cigarettes results in 21,000 premature deaths every year, and many more thousands with chronic ill-health, then it does make sense to apply restrictions as soon as possible to this new product, the NVPs. Though at the same time working strenuously to apply similar restrictions (or preferably total prohibition) as soon as possible to cigarette smoking.