EXPERT REACTION: Australia to ban import of e-cigs and nicotine refills
It is being reported this week that Australia is set to ban the import of e-cigarettes and nicotine refills from next month. The ban, which will be in place for 12 months while the Therapeutic Goods Administration considers the regulation of nicotine products, will see devices and refills only available via a doctor's prescription. Australian experts response.
Organisation/s: Macquarie University, The University of Melbourne, The University of Queensland, University of Technology Sydney (UTS), The University of Newcastle, Quit Victoria, Australian Council on Smoking and Health, University of South Australia, Telethon Kids Institute
These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.
The Australian Council on Smoking and Health strongly supports the recent decision by the TGA to ban importation of nicotine from 1 July, 2020.
This decision is based on the available evidence and is aimed at protecting public health in Australia.
The evidence that e-cigarettes help people quit smoking is very weak, and there is strong evidence from the US, Canada and elsewhere of an epidemic of e-cigarettes use by young people
This approach will certainly prevent access to e-cigarettes and refills via commercial channels within Australia. However, the legislation has not banned person use. Therefore, private trade by people having frequent overseas trips may boom. In addition, it creates a big hurdle for researchers to access such products for research purposes. Australia is currently leading the research on the physiological response to e-vaping. Such a ban can move research away from this field.
Professor Christine Paul is Head of Research SMPH and Acting Director of the Hunter Cancer Research Alliance, and is from the School of Medicine and Public Health at the University of Newcastle
As the UK National Health service states: 'E-cigarettes aren’t completely risk free but they carry a small fraction of the risk of cigarettes'.
We are still finding out about those risks – including how big that ‘small fraction’ is. We won’t know the full risks of e-cigarettes for decades. We also know there are some down-sides relating to youth vaping and smoking.
If we want to help smokers to quit, or reduce the level of smoking-related harm, these products need to be used the way we know they can be effective – that is, combined with expert face-to-face support. For these reasons, limiting e-cigarettes to prescription-only makes sense for now.
Dr Gary Chan is a NHMRC Emerging Leadership Fellow at the Centre for Youth Substance Abuse, in the Faculty of Health and Behavioural Sciences at the University of Queensland
The current scientific evidence has pointed out that an e-cigarette contains much less harmful chemicals than a combustible cigarette, thus is likely to confer substantially lower health risk than tobacco smoking. Our recent research has demonstrated that an e-cigarette is likely to be more effective than other nicotine replacement therapy products such as nicotine patches in helping smokers to quit smoking.
There are concerns about e-cigarette use among young people, but the evidence that e-cigarettes are causing young people to take up smoking is quite weak. Most modelling studies have shown that there are public health benefits to e-cigarette because smoking related diseases, such as lung cancer, are one of the top preventable causes of death in many developed countries, including Australia. A sensible policy would be to encourage smokers who have difficulty quitting tobacco to switch to nicotine e-cigarettes, and implement policies, such as taxation, age limit (e.g. 21+ years old) and an advertising ban, to discourage the uptake of e-cigarettes use among young people.
In short, from a public health perspective, it does not make sense to ban e-cigarettes but allow a more harmful product – the combustible cigarette – to be freely available.
My research is in oral cancers and smoking is a big risk factor. Any policy decision to reduce smoking or access to chemicals which are considered as carcinogens will have an effect on cancer rates. We just don’t have enough evidence that vaping is not a risk, long term clinical studies will be needed to determine if there are any detrimental effects to vaping. I think we are moving in the right decision. Also patients with oral cancers have very bad scarring due to invasive surgery. It makes more sense to ban the substances than treat a stage IV patient.
Vaping replicates the activity of smoking. i.e. the vaper inhales the vaporised mist into the lung just as a smoker inhales smoke into the lung. In the absence of nicotine, this repetitive behaviour conditions the brain normalising the hand to mouth activity. This should be of a huge concern to parents of adolescents who are often willing and eager to try new things.
All scientists would agree that vaping has risks. Vaping delivers a mist into the lung which then rapidly circulates in the body.
The risks are:
1. what is in the solution?
2. how was it made?
3. what effect does it have on different individuals?
These issues are all currently under worldwide investigation.
While these investigations are occurring, Australia has approached the issue very cautiously. As a result, we are not seeing the increases in vaping evident in some other countries or many of the associated serious health consequences that continue to emerge.
What of the vaping shops. Should we not also require a script for a vaping device? And should we also consider these devices as medical equipment?
The debate is yet to occur. The TGA will collate the evidence and deliver an informed verdict.
I welcome the Government’s recent announcement of a 12-month ban on the importation of e-liquids containing nicotine. This presents a positive step towards regulating a harmful drug of addiction, although it is important that the ban is actually enforced.
If enforced properly, this ban will be highly beneficial in preventing adolescents and other vulnerable populations from buying nicotine-containing e-liquids, and hence stop them becoming addicted to e-cigarettes. Users of nicotine-containing e-cigarettes will still be able to approach their GP for a prescription to import liquid nicotine.
This means that current e-cigarette users who have used them to assist in quitting tobacco should not be disadvantaged, nor should they have to return to smoking tobacco. With a range of studies, including one published by Telethon Kids Institute researchers, showing that e-liquids often contain potentially dangerous chemicals, in addition to illegal nicotine, this ban should have significant benefits for public health in Australia.
Limiting e-cigarettes to prescription only whilst allowing the widespread sale of cigarettes is not good public health policy. E-cigarettes should be easier to access, especially for heavy smokers, many of whom have tried many times to quit. Not all smokers find NRT effective. A range of NRT options should be available to people. I am afraid not all GPs will be confident to prescribe and pharmacists to dispense nicotine liquid in a short time frame. This action will cause a lot of anxiety among people trying to quit smoking with e-cigarettes.
Nicotine containing liquid has already been restricted for e-cigarette use in Australia and available only if prescribed by a doctor, so this is not a new change. The dose and availability of nicotine used via e-cigarettes is highly variable and unregulated.
Those who switch to e-cigarettes are more likely to continue their use of nicotine long term than those using nicotine replacement therapy. E-cigarette use in pregnancy may be of concern due to the potential effects of nicotine and solvents on the unborn baby. In contrast, using nicotine replacement therapy is safe, effective and well researched, but tends to be under-utilised by most smokers as a quit strategy. Improving access to higher doses of conventional nicotine replacement therapy through subsidised use of combined patches and oral forms is warranted. NRT is more effective when used with supportive counselling from the GP and/or the Quitline.
Epidemiological studies show e-cigarettes have helped reduce the smoking rates and consider them effective in smoking cessation. Rationally, receiving only nicotine through these devices may be less harmful than smoking tobacco.
However, physiological studies have also shown that e-cigarette use is associated with increased oxidative stress in human bronchial and lung epithelial cells which can result in inflammation and cytotoxicity. Oxidative stress leads to cancer, cardiopulmonary pathogenesis, and neurodegenerative disorders. There are also reports of reduced lung function among e-cigarette users.
Currently, there is data on both positive and negative effects of e-cigarettes on human health. At present there are no data regarding the long-term effects (e.g. cancer risk) associated with e-cigarette use and in my opinion the use should be limited until there’s enough information on harm or benefit of these devices to human health.
The importation ban that prohibits people from importing nicotine directly from an overseas supplier is eminently sensible. Robust evidence on the effectiveness of e-cigarettes for smoking cessation is still quite limited. And while there are vocal e-cigarette enthusiasts who have quit smoking, there are also multiple surveys and studies showing there are more people who try and then discontinue e-cigarettes (and keep smoking) or who try e-cigarettes and end up using both.
Like the tobacco industry, the e-cigarette industry needs new clients for profit and growth; I would suggest that this importation ban is passing the industry “scream test”.
GPs can still, albeit under more controlled processes, provide a nicotine prescription for people who have not succeeded in quitting with TGA-approved pharmacotherapies. A pharmacist can still dispense or compound nicotine for use in an e-cigarette by a named patient holding a valid prescription. This measure does, quite appropriately, curtail “self-prescription” (and “for-profit prescription”) and the burgeoning recreational use of e-cigarettes.
This crackdown on the illegal importation of e-cigarettes and nicotine is welcome news. It will ensure that the only way these harmful devices can enter Australia is via a TGA-approved pathway. This will minimise the risk of the devices getting into the hands of vulnerable populations, especially adolescents (among whom e-cigarette use has tripled in recent years).
Individuals wanting to use e-cigarettes will need to visit their GP for a prescription and thus prove they are using the devices for smoking cessation, not recreational, purposes.
Many will argue that visiting a GP to obtain a prescription is onerous but behavioural support for smoking cessation improves quitting success, making these consultations important to therapeutic outcomes.
There is evidence from clinical trials and observational studies that nicotine vaping can help smokers quit smoking.
Australia already has some of the world’s most restrictive laws for use of nicotine vaping products. The ban on personal importation will make it even more difficult for smokers to access this option.
The government appears to be keeping some access options open, but it is unclear how these will operate in practice and how difficult it will be for doctors and pharmacists to obtain authorisation to import and supply nicotine vaping liquid on prescription to people who smoke.
Regular tobacco cigarettes represent the greater threat to public health, and should be the focus of greater regulation. When compared to this extreme regulation of vaping products, it is quite astounding that tobacco cigarettes, which are much more harmful than vaping, are still able to be sold from convenience stores and supermarkets.
The proposed policy threatens adult smokers who use e-cigarettes without a medical prescription with draconian fines. It moves Australian policy further away from the policies adopted towards e-cigarettes in Canada, New Zealand and the UK, all of which allow smokers to access e-cigarettes to help quit smoking or to use as a lower risk product than smoking cigarettes. The Australian policy intensifies the existing de facto prohibition of e-cigarettes because very few doctors will prescribe e-cigarettes now and fewer will be prepared to do so under this punitive policy.
The proposed ban on adult use of these e-cigarettes is justified on the basis of protecting youth from using e-cigarettes and going on to smoke cigarettes. By this logic, a more effective way of preventing youth cigarette smoking would be to prohibit the sale of cigarettes.
I support effective policies that would minimise youth uptake of both conventional and e-cigarettes. But these do not include treating nicotine solutions like illicit drugs while allowing the free and largely unregulated sale of much more dangerous tobacco cigarettes. The proposed policy is a recipe for increasing the size of the illicit market in e-cigarettes.
A much better policy would be one that allowed the sale of e-cigarettes that meet consumer safety standards as consumer products to adults. These could be sold via a restricted range of outlets that youth are less able to access, such as tobacconists or adult stores, and sales from these outlets could be closely monitored.
Compared to tobacco smoking, e-cigarette use is associated with a large reduction in the quantity of inhaled toxins. However, e-cigarette users still inhale numerous toxins, some of which are unique to e-cigarettes, such as flavour additives. Similarly, the lack of oversight of the manufacture of e-cigarettes means that many products contain higher levels of nicotine than advertised. Since it is unknown whether the reduction in toxins with e-cigarette use is sufficient to lead to long-term health benefits, the TGA has proposed to ban the importation of nicotine containing e-cigarettes.
The TGA’s position still allows nicotine-containing e-cigarettes to be imported with a valid prescription from a medical practitioner. In doing so the TGA acknowledges that some research suggests that e-cigarettes may be a more effective method for quitting smoking for a small percentage of smokers. Continued research will hopefully provide medical practitioners with the necessary understanding to identify those smokers who are likely to achieve complete cessation after a short-term e-cigarette use rather than becoming life-time e-cigarette users or dual tobacco and e-cigarette users.
I welcome the Government’s initial actions that became necessary because the existing regulations were widely flouted. Bringing permissions for importation of nicotine containing e-cigarettes under the TGA through a special access scheme is a sensible interim step.
This should be through a named patient provision with genuine declarations of indication for use and the absence of an approved alternative treatment. Highly addictive e-cigarette products such as JUUL that represent a hazard for youth in particular should not be approved and periods of approved use should be consistent with recommendations of RACGP and others that the marginal role of e-cigarettes is only for short-term use in smoking cessation.
Adding an authorised prescriber model would only be necessary if the named patient provisions were inadequate. Based on recent events, there is significant risk that this process would be abused.
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