In this exclusive interview, we delve into the contentious world of nicotine vaping regulation in Australia. We discuss the issue with Dr. Colin Mendelsohn, a leading educator, author, and expert from Sydney General Clinic and the author of the book Stop Smoking, Start Vaping. With over two decades of clinical and research experience in tobacco control, Dr. Mendelsohn provides valuable insights and solutions in this conversation.
Together with his colleagues Alex Wodak and Wayne Hall, Dr. Mendelsohn discusses the current regulatory approach in Australia from a medical standpoint in their latest article published in the Drug and Alcohol Review journal. In “How Nicotine Vaping Should Be Regulated in Australia,” the authors argue that the current policy has inadvertently fueled a thriving black market, leaving children and adults exposed to the risks of unregulated vaping products. They propose a rigorously regulated consumption model that ensures age verification and aligns Australia with Western nations, demonstrating commendable practices and promising outcomes.
Amid growing concerns and contrary to its initial objectives, the medical prescription model for vaping adopted in Australia has left adult smokers in the dark. In our conversation, Dr. Mendelsohn addresses the need for a regulatory balance that meets exemplary international standards while protecting public health interests.
This revealing interview highlights the urgency of a paradigm shift in both mindset and political practice as governments worldwide grapple with the complex interplay of discourses and narratives around the risks and benefits of nicotine vaping. This is especially pertinent in a global context where smoking remains a formidable adversary, with a staggering 1.3 billion users and causing 8 million deaths annually.
Your recent study suggests that nicotine vaping products should be sold without prescription in Australia. Could you explain the key findings of your research that led you to this conclusion?
Australia is the only country in the world that requires vapers to have a medical prescription to possess and use nicotine. The regulations were intended to prevent vaping among youth and allow access for adult smokers as a quitting aid. However, after 18 months, they have clearly achieved neither of these objectives. Consumers and prescribing doctors themselves have rejected the prescription model. As anticipated, this has created a thriving black market selling illegal and unregulated vaping products to both youth and adults.
You mentioned that the current prescription model has been rejected by doctors and consumers, leading to a thriving illicit market. Can you provide examples or case studies that illustrate the extent of this issue in Australia?
It’s difficult to find a doctor who will prescribe nicotine in Australia. Less than 1% of general practitioners are publicly registered as nicotine prescribers. Additionally, doctors are skeptical about vaping. They are constantly exposed to negative advice from the government, health organizations, and mainstream media. Moreover, only a handful of Australian community and online pharmacies dispense nicotine liquids.
It’s no wonder that only 8% of vapers have a nicotine prescription. It’s much easier to buy deadly cigarettes. Most vapers purchase their devices on the black market, which sells unregulated products to both adults and children. The uptake by youth is generating significant concern in the community, fueled by sensationalist reports in the media.
In your opinion, what are the most significant challenges lawmakers face in trying to find an optimal balance between making vaporizers accessible to adult smokers and restricting access to minors?
Vaping should be readily accessible to adult smokers. Period. Nicotine vaping is a lifesaver for many smokers. Those who switch experience dramatic improvements in their health and quality of life. The main challenge for policymakers is restricting access to young non-smokers. Vaping products should only be sold in licensed retail establishments where reliable age verification is available, such as vape shops and outlets where tobacco is sold.
Vaping products should not be especially appealing to youth. Flavor names should have generic descriptions, e.g., “caramel.” Packaging should not include colors, images, and language targeted at children and appealing to youth. Public education should present vaping as a quitting tool targeted at adult smokers. A clear message should be conveyed that vaping is not for youth or non-smokers.
How do you envision the role of the Australian Competition and Consumer Commission (ACCC) and organized civil society in regulating nicotine vaping products as consumer goods?
In Australia, nicotine vaporizers are regulated as medicines by the Therapeutic Goods Administration, the drug regulatory agency. However, nicotine vaporizers are consumer products designed to replace another consumer product, deadly combustible cigarettes. It’s more appropriate for them to be regulated by the Australian Competition and Consumer Commission (ACCC), which regulates consumer goods and can provide good protection for users. The ACCC would be responsible for setting and enforcing comprehensive standards for vaping liquids, packaging, labeling, health warnings, and advertising. It would also establish a pre-market notification system for nicotine liquids and a post-market surveillance system to report adverse events and defective products.
Your study suggests that nicotine liquids should be sold in specialized vape shops, pharmacies, and general retail stores. How do you propose these retailers obtain licenses and be supervised to ensure compliance with regulations?
All retailers would need a license to sell nicotine liquids, just as is required for cigarettes. The state Health Departments would organize licensing. Strict age verification at the point of purchase would be required, with severe penalties and license revocation for sales to minors. Mandatory CCTV recording of sales could be considered as a condition for obtaining a sales license. Retailers would pay an annual license fee, submit annual reports, and be subject to compliance checks. Under this model, the black market would become less profitable, and illicit sales would decrease over time. A legal and regulated market would largely replace it, providing safety for consumers.
Can you discuss the possible negative consequences of well-intentioned but harsh measures to discourage vaping among youth, such as flavor bans and tax increases?
Poor policy formulation can have unintended and negative consequences in vaping regulations. For example, flavor bans aimed at reducing vaping among youth have often been counterproductive. We know that a ban on flavored tobacco and vaping products in San Francisco in 2020 resulted in more than a doubling in cigarette smoking among high school students. Among adults, vaping decreased, and tobacco smoking increased.
Raising taxes on vaping products has led to an increase in tobacco use among minors, young adults, and adults. Efforts to reduce youth vaping through legal age restrictions have paradoxically led to an increase in tobacco use among this age group. Bans and strict regulations push drugs into the black market and often cause greater harm. The prohibition of vaping in various jurisdictions has led to continued use, an increase in cigarette sales, and a shift towards illegal markets and more sales to youth.
You recommend updating Australia’s vaping standards to ensure only safe and high-quality products are available. What improvements would you like to see in the current TGO 110 standards?
The current TGO 110 standards are rudimentary and need to be updated. Other international standards, such as the European Union’s Tobacco Products Directive (TPD), are much more detailed and comprehensive.
Minimum standards for the manufacture and safety of vaping liquids and devices are required. These should include electrical, thermal, mechanical, and chemical safety, standardized testing regimes, purity standards for ingredients, a comprehensive list of prohibited ingredients, dose limits for problematic ingredients, laboratory testing, and possibly emissions testing. Reasonable limits for nicotine are 20 mg/ml for freebase nicotine and 50 mg/ml for nicotine salts (as in New Zealand).
In your proposal, you mention the importance of public communication and targeted advertising to communicate the relative risks of vaping. How would you ensure these messages are accurate, effective, and not appealing to minors?
Public messages should communicate the absolute and relative harms of nicotine vaping compared to smoking and present vaping as a less harmful alternative for adult smokers. Messages aimed at youth should emphasize that no nicotine-containing product is completely safe to use. They should inform young people that vaping can lead to addiction and that they should never start using any tobacco or nicotine products. All messages must be accurate and avoid exaggerating risks.
Restricted and responsible advertising with a “switch” message could be used to target smokers who cannot or do not wish to quit entirely. However, any advertising that could appeal to youth, such as lifestyle ads associating vaping with positive imagery and adventures, should be prohibited. Advertising should be placed and scheduled to minimize exposure to underage youth.
What kind of system would you propose for reporting adverse effects and withdrawing unsafe products in a regulated vaping market?
As with other consumer products, a post-market reporting system is needed to report any adverse effects after products enter the market. This would also allow for the withdrawal of unsafe products. The Australian Competition and Consumer Commission (ACCC) would be the most suitable agency.
Can you provide examples of similar regulatory models successfully implemented in other Western countries, such as the United Kingdom, New Zealand, the United States, and Canada?
The United Kingdom, New Zealand, the United States, and Canada have adult consumer models similar to what we recommend for Australia, but slight differences exist.
In the UK and Canada, the nicotine limit is 20 mg/ml, and currently, there is no maximum limit in the United States. In New Zealand, the limit is 20 mg/ml for freebase nicotine and 50 mg/ml for nicotine salts. The minimum sale age is 21 in the United States and 18 in the other countries. Advertising is not regulated in the United States but is restricted to varying degrees in other countries. The UK has a limit of 10 ml for nicotine liquids and 2 ml for tanks or cartridges. New Zealand has a maximum bottle size of 120 ml.
The tax rate is 15% in New Zealand, 20% in the UK, and around 30% in Canada. Taxes vary by state in the United States. New Zealand and the UK have a pre-market notification system. Manufacturers notify the regulator of compliance before marketing. The United States has a pre-market authorization system requiring regulatory approval of each product before marketing.
In the long term, how do you foresee a carefully regulated consumption model for vaping affecting tobacco-related death and disease in Australia?
Smoking is the leading preventable cause of death and disease in Australia. Many smokers cannot quit smoking despite repeated attempts. Two out of three continuous smokers will die prematurely due to smoking.
If smokers had better access to vaping devices, more people would quit smoking, with significant improvements in public health. A modeling study in Australia estimated substantial public health benefits if vaping were made more widely available.
How do you propose to address potential opposition or concerns from public health organizations and advocacy groups that might argue that more accessible vaping products could lead to an increase in nicotine addiction or dependency and potential health risks?
We must remember that vaping is not risk-free, but it is much safer and less addictive than smoking. For smokers who transition, there are substantial health improvements. Any risks associated with vaping must always be compared to the alternative, which is continuing to smoke. While evidence increasingly supports vaping, these counter-arguments are often raised to hide underlying political, ideological, or particular interests.
What measures would you recommend to ensure that nicotine vaping products do not disproportionately affect disadvantaged communities and vulnerable populations?
Actually, there’s a strong argument for targeting marginalized and disadvantaged groups with vaping. These populations have high smoking rates and low cessation rates with conventional treatments. There’s growing evidence that vaping could be particularly beneficial here and help reduce health and financial inequalities.
How would the proposed regulations on vaping products affect the tobacco and Nicotine Replacement Therapy (NRT) industries in Australia? Do you anticipate any resistance from these sectors, and how would you address it?
Vaping is a substitute for smoking. We’ve seen in other countries that as vaping rates increase, cigarette sales decrease. Similarly, vaping is the most popular method for quitting smoking in Western countries and has led to a decrease in sales of NRT products.
Big pharmaceutical companies oppose vaping because it poses a threat to the sale of their products. Big tobacco companies are slowly transitioning towards safer nicotine alternatives, such as vaping products, heated tobacco products, and nicotine pouches, which is a positive move.
In your study, you mention risk-proportional taxes, similar to those on nicotine gums and patches. How do you propose determining the appropriate tax levels for various vaping products to ensure they remain accessible to adult smokers looking to quit?
Tobacco taxes are high to discourage the use of deadly combustible cigarettes. However, vaping is a vital, tobacco-free, and combustion-free quitting tool, and its cost should be kept as low as possible. The Royal College of Physicians in the UK recommends a tax of 5% of the tobacco tax, that is, proportional to the relative risk of vaping compared to smoking.
Tobacco use is increasingly concentrated among disadvantaged and low-income populations, so lower prices could be a powerful incentive to switch to the safer alternative. The lower the price of vaping products, the more likely it is that more people will transition.
How can the government monitor and evaluate the effectiveness of these proposed regulations to reduce tobacco-related death and disease and minimize youth vaping over time?
The government should monitor compliance with age-of-sale laws and compliance with standards and regulations in vaping products. Regular surveys on smoking and vaping rates would monitor the success of the regulations. We would expect to see an increase in vaping rates as smoking decreases.
How would you address concerns that increasing access to vaping products might renormalize smoking behavior or create a perception that vaping is an alternative to tobacco for everyone, not just for smokers looking to quit?
The main indicator of renormalization would be the stabilization or increase in smoking rates. In fact, the opposite is happening. Smoking rates have decreased more rapidly in the UK, the US, and New Zealand since vaping became widely available.
According to Public Health England, I quote, “There is no evidence that e-cigarettes are undermining the long-term decline in cigarette consumption among adults and young people, and in fact, they may be contributing to it.”
Vaping is largely limited to smokers and ex-smokers. Use by adults who have never smoked is rare. Vaping must be positioned as a smoking cessation aid for adult smokers, I repeat. However, it can also play a role for non-smokers who might otherwise start smoking.
What strategies would you recommend for educating the public, especially minors, about the relative risks and harms of vaping without inadvertently promoting its use?
The key message here is that vaping is a smoking cessation aid for adult smokers and is not recommended for non-smokers, especially the youth. It should be emphasized that vaping is not risk-free and poses potential dangers to non-smokers. However, the message should be clear for smokers: it is a much, much safer alternative to smoking. Vaping users should only attempt to quit vaping when they are confident they will not relapse into smoking.
As vaping technology and products evolve, how do you imagine the regulatory landscape will adapt to these changes to ensure public health and safety are maintained?
I believe vaping products will become safer and more effective over time. Any harmful substances identified can be removed, and improvements in technology will result in more sophisticated and safer products. However, ongoing monitoring and research will be needed to identify potential health issues and minimize risks as much as possible. Standards must be updated regularly as new information becomes available and new risks emerge.
Considering all the challenges and considerations discussed, what would be your key recommendations for Australian lawmakers in the future to ensure effective regulation of nicotine vaping products? And, finally, what are your thoughts on the potential long-term impact of these proposed changes on public health, the vaping industry, and society in Australia?
Policymakers in Australia must find a balance between allowing easy access to nicotine vaping devices for adult smokers and restricting access to the youth. Concerns about vaping among the young are legitimate, and strict measures should be taken to minimize their use by them, especially non-smokers.
However, the risks of vaping among the youth are relatively minor compared to the enormous potential benefits for their parents and grandparents who have quit smoking through vaping. We should not let exaggerated concerns about youth vaping undermine the potential of vaping to help adult smokers quit. If we find the right balance, there are huge potential benefits for public health and society at large by finally eliminating the scourge of smoking.
Mendelsohn C, Wodak A, Hall W. How should nicotine vaping be regulated in Australia? Drug Alcohol Rev. 2023 Apr 18. doi: 10.1111/dar.13663. Epub ahead of print. PMID: 37071577.
More information about the book Stop Smoking Start Vaping at www.colinmendelsohn.com.au/book. The book and the eBook are available on Amazon and other online stores.
This interview was conducted in May 2023 and originally published in The Vaping Today.
