Nine years ago I walked through the streets of London towards the impressive Royal Society building to attend the inaugural E-Cigarette Summit. I went to a conference where the debate was split, where optimism based on basic science was confounded by a dearth of studies, and where it looked like the UK faced an imminent ban on vaping devices.
How things have changed. After ten years in which vaping has been banned or severely restricted in much of the world, the UK has become the beacon of hope for tobacco harm reduction in the form of vaping. Much of that is due to the E-Cigarette Summit, which brings leading researchers, policymakers and more to share the latest research and views.
The E-Cigarette Summit is the best way I know to rapidly update your knowledge of what’s happening with research and policy. In this post, my co-writer, Kayleigh Jenkins and I present a summary of what was said at the 10th Summit. As always, we can’t catch or report everything, we have to make our own judgements on what to include and any mistakes are our own.
Also see: E-Cigarette Summit 2023
- Science and Evidence
- Opening Keynote: Tobacco is a public health emergency
- Independent review on nicotine vaping in England: an overview of what we said and why
- Flavours in e-cigarettes: Public health issues and regulatory challenges
- The absolute and relative risks of electronic cigarettes in a wider public health context
- Cochrane review updates, Smoking vs nicotine use in late pregnancy
- Can e-cigarettes be recommended to pregnant smokers?
- Policy & Research
- The hopes and fears for the public health impact of e-cigarettes
- The causes and consequences of the rise in disposable vaping
- The impact of policy changes, that are designed to protect young people, on smokers and vapers
- Listening to young smokers and vapers talking about disposables
- Maximising existing opportunities to reduce health inequalities
- Illusions, delusions, and a few conclusions
- Industry, Regulation and Public Health
- PHE, OHID and Tobacco control in England
- Avoiding missteps in nicotine regulation: what can we learn from patterns of nicotine intake from cigarettes?
- The achievability of a UK medicinal licence
- Who would have thought we’d be talking about disposable e-cigarettes at the tenth edition of the London E-Cigarette Summit?
- E-cigarette legislation in Ireland. The good, the bad and the ugly
- THR, Nicotine & End Game
- A conceptual model for measuring and understanding the possible role of alternative nicotine products and policies for reducing smoking
- New Zealand’s tobacco endgame policies: Cause to celebrate, or harmful folly?
- The State of the harm reduction debate in the United States
- Nicotine and tobacco control in LMIC
- When the end game is not the end – the new battlelines in Norway
- The UK government’s approach to e-cigarettes
Science and Evidence
Opening Keynote: Tobacco is a public health emergency
Prof. Sanjay Agrawal, Professor of Respiratory Science, Institute of Lung Health
Prof Agrawal reviewed the history of the Royal College of Physicians (RCP) - from its formation (By King Henry VIII) in 1518 up to 1962 when the ‘Smoking and Health’ report was released.
This report was the first to link tobacco smoking to disease (at a time when 70% of men smoked) and suggested ways to tackle this. Despite pushback from the media, public and politicians it laid out the first pillars of Tobacco Control. This led to the formation of ASH (Action on Smoking and Health) in 1971 - which advocates for tobacco control in the UK and around the world.
In 2015, after reviewing the existing evidence, the RCP concluded that e-cigarettes should be used in tobacco harm reduction.
Now, 60 years after the Smoking and Health report, while smoking rates are falling amongst all age groups, the number of smokers and tobacco-related deaths is still high, with over 8 million tobacco-related deaths in 2019 and one in 7 people still smoking. This can be mainly attributed to a combination of addiction, profit and politics.
One of the pillars of tobacco control laid out in the 1962 report was treatment - and now we thankfully have e-cigarettes as one of the treatments available, and it has been embraced in the UK.
But there are still challenges and polarisation - with tobacco companies using new media forms to maintain uptake and use of their products.
"The key to success in tobacco harm reduction is collaboration - working together, sharing data, exploring, innovating, building trust and talking to each other.”
Independent review on nicotine vaping in England: an overview of what we said and why
Dr Debbie Robson RMN, PhD, Senior Lecturer in Tobacco Harm Reduction
Debbie started by stating that vaping is not risk free but carries a small fraction of the risk of smoking. (This does come with a proviso that we can be more confident about that in the short and medium term than the long term.)
Debbie looked in detail at biomarkers of exposure. These are a measure of how much of a substance or toxicant is present in the body.
The good news is that biomarkers are far lower for vaping than for smoking. However, we need to be aware that it is better to not vape or smoke, because some biomarkers are higher for vapers than for non-smokers.
However, some of these biomarkers are not statistically significant, and there are no major concerns about health impacts from vaping in the short and medium term.
Debbie also pointed out some of the confounding factors when looking at the impact of vaping on biomarkers. For example, someone in London is already exposed to many pollutants, which can affect their biomarkers. It’s different for someone who lives in leafy Surrey, who won’t be exposed to the same amount of pollution. It can be tricky to distinguish between factors such as air pollution and any impact from vaping.
We need to be really careful how we communicate information like this. Vaping is clearly significantly safer than smoking - but while we debate the safety of vaping, millions of people are dying from smoking.
Flavours in e-cigarettes: Public health issues and regulatory challenges
Prof. Maciej L. Goniewicz, Professor of Oncology, Department of Health Behavior, Division of Cancer Prevention and Population Studies
Goniewicz has been studying the effects of flavours in non-cigarette tobacco products. Flavoured tobacco is still popular in the US and, while flavours can increase toxicity, cigarettes are so toxic anyway the addition of one more chemical doesn’t really make much of a difference. However, flavours are very effective for marketing in the industry.
What about ENDS (Electronic Nicotine Delivery Systems)? Flavours can play a role in transitioning smokers and dual users to vaping, especially as first contact with the products and in sustaining their use.
Non-tobacco, particularly fruit, sweet and candy flavours, are most popular with both children and adults across many studies. Most of the flavours here are not traditional. Many come from the food or fragrance industry and are created by mixing chemicals.
[Note that in the EU and UK natural flavourings in e-liquids are banned. However, in contrast to the US, vape devices and e-liquid has to undergo emissions testing, and many EU-based e-liquid manufacturers have used this data to eliminate flavour compounds which could cause harm.]
Goniewicz studied several thousands of ENDS products, and found over 350 different flavouring chemicals. On average, 14 different flavouring chemicals were identified in ENDS products and most contained respiratory irritants. However, some of these may change when they are heated due to chemical reactions.
What’s the impact of using these flavours on ingestion and inhalation? Different flavours (and different concentrations of flavours) can cause different levels of respiratory inflammation. So the health effects of flavoured ENDS are likely to be different in different flavour groups.
Goniewicz sees the same when flavours are tested on cells. For example, different flavour groups lead to different inflammation in invitro cells.
What does this mean for public health and for regulators? It’s very challenging and complex to regulate flavours and requires a panel of experts. Enforcement is difficult too. It can be based on many things including flavourings, ingredients and product descriptors (labelling). However, where there have been flavour bans, they have had mixed results.
The absolute and relative risks of electronic cigarettes in a wider public health context,
Prof Alan Boobis, OBE, Emeritus Professor of Toxicology & Chair - UK Committee on Toxicity
The speed at which nicotine hits the bloodstream is what drives satisfaction, so it's super important. That’s why treatments such as nicotine gum are just not as satisfying as smoking. While early e-cigarettes were not very effective, modern third and fourth-generation devices seem to have a speed of delivery close to that of cigarettes. But are you jumping from the frying pan into the fire? Toxicology suggests this is not the case.
Vapour can look alarming, but it is important to remember that what you see is aerosol - not smoke. This aerosol is relatively non-toxic, although we can not be sure about the long-term effects.
It’s true that nicotine is addictive and a CNS stimulant, but this is important for switching - dropping the nicotine level would be counter effective as vapers would just switch back to smoking.
Cigarette smoke toxins are either not present in vapour, or are present in much lower levels. For example, TSNAs (Toxic Carcinogens in Cigarettes) are at vanishingly low concentrations in current e-cigarettes, with NNK (a tobacco-specific nitrosamine) in vapour being less than 0.3% of the level found in cigarette smoke.
It’s true that some toxins are at slightly higher levels in users than non-users - but it’s important to remember the background, as sometimes detected toxins can come from background air, not the device. Overall, exposure to more toxic chemicals is very low to negligible.
Boobis also discussed flavours. While there are many, there are only a handful that are prevalent. These flavourings are also used in food. (In a previous presentation, Boobis pointed out that these are also heated in ovens.) Once in the body, systemic effects are the same. Evidence to date has not indicated any particular concern in the lungs. Some are potential sensitisers, but Boobis can’t see any evidence that vapers are at an increased risk from this.
What about heating the product? Degradation at vaping temperatures is low, and adverse effects are not anticipated.
The conclusion is that e-cigarettes are substantially safer, although it is hard to put a number on this. They are not without any risk, so are not recommended as a life choice. However, they are very low risk to bystanders. Data has been accumulating for 10 years, the evidence gap is narrowing, and we are not seeing an epidemic of ill health amongst long-term vapers.
Boobis touched on youth use and argued that the answer to this is not banning vaping (as we have seen, this has backfired in countries like Australia) but in regulating them properly.
Cochrane review updates
Dr Jamie Hartmann-Boyce, Associate Professor and Editor Cochrane Tobacco Addiction Group
The Cochrane group conducts what is considered the gold standard in randomised control trials.
Their latest report update (Nov 2022) focuses on exploring the effects of giving e-cigarettes to smokers with the explicit purpose to help them quit smoking or transition to vaping.
- Nicotine e-cigarettes vs nicotine replacement therapy (NRT): More people successfully quit in 6 months or longer using e-cigs. Concluded with high certainty.
- Nicotine e-cigarettes vs non-nicotine e-cigarettes: More people quit using nicotine e-cigarettes at 6 months or longer. Concluded with moderate certainty.
- Nicotine e-cigarettes vs behavioural support/no support: Those using nicotine e-cigarettes showed higher quit rates. Concluded with very low certainty - due to risk of bias from subjects.
Another recent study with ASH and the Office of Health Improvement and Disparities concluded that just over 50% of smokers who were given e-cigarettes to help them quit smoking were still using them after 6 months or more, with the number who had completely quit smoking having a rate of over 75%.
A final, very recent study focussed on biomarkers of potential harm & risk amongst those who don’t quit smoking and are dual using (smoking and vaping). This showed consistent results, with dual use (both smoking and vaping) showing biomarkers of lower levels of potential harm and risk than exclusive tobacco smoking.
Can e-cigarettes be recommended to pregnant smokers?
Prof Peter Hajek, Director of the Health and Lifestyle Research Unit, Wolfson Institute of Population Health, Queen Mary University of London
Smoking restricts prenatal growth and leads to a lower birth weight. There are other factors such as high levels of stress and medication use amongst smokers, and this makes it harder to judge other negative outcomes of smoking.
Hajek led a study that compared NRT with electronic cigarettes in late pregnancy. More people continued using e-cigarettes than NRT, and more people quit with e-cigs than with NRT. Even non-quitters were more likely to reduce smoking with e-cigarettes than with NRT. Low birth weight was more common in the NRT arm - not because of the NRT, but because e-cigarette users were more likely to stop or reduce their smoking. Exclusive users also reduced nicotine limits, but dual users increased nicotine - but there is a bit of mystery here which needs further investigation.
Quitting smoking without nicotine is obviously the best option, but for smokers who can’t do this, we should recommend use of e-cigarettes.
Policy & Research
The hopes and fears for the public health impact of e-cigarettes
Professor Robert West, Professor Emeritus of Health Psychology
West compared the hopes and fears around vaping ten years ago to what is hapopening today. West himself had been an optimist - thinking that if you could deliver nicotine effectively you could make smoking obsolete.
In reality, neither all hopes nor fears were achieved.
Are e-cigarettes as safe as fresh air? Not quite. But the figure of 5% less harmful than smoking is often bandied around, and West thinks that the actual risk figure will be far lower than 5%.
Are they leading to new nicotine addiction? West is not worried about this. It’s actually quite difficult to get people addicted. High smoking prevalence took centuries to achieve and involved huge resources and a cultural change. If you look at animal studies, it’s actually quite hard to get animals addicted to pure nicotine, and usually requires combining nicotine with other elements such as sucrose. [As we have noted before, cigarette smoke also contains addictive elements above and beyond nicotine.]
Have people switched wholesale? Not, not really, but people who use e-cigarettes to quit smoking are significantly more likely to be successful.
It doesn’t seem to have reduced health inequalities, but at the same time, it hasn’t been a gateway to smoking at a population level - although it was always difficult to fathom the logic behind the gateway theory.
One of West’s biggest concerns is the toxicity in the vaping debate, which is now worse than it has ever been. People are contesting results based on their values system rather than the science, and are using double standards when they evaluate the evidence. We even have people moving the goal posts - for example, some have demanded randomised control trials, then said they are ‘rubbish’ when we have them.
West outlined his hopes for a scientific ecosystem which would advance knowledge and eliminate bias barriers to science. He also hopes vaping will be regulated in a way that maximises uptake and that countries will take their FCTC (Framework Convention on Tobacco Control) obligations seriously. [This refers to an obligation to use tobacco harm reduction to reduce the harms of smoking.]
The causes and consequences of the rise in disposable vaping
Harry Tattan-Birch, PhD student in Epidemiology and Public Health
Results discussed in this session are from the Smoking Toolkit study - a monthly study of adults in Great Britain.
The rise of disposables has been one of the biggest changes in UK vaping history.
It is most prevalent in younger vapers - with just 1% of 18-year-old vapers using them in Jan 2021, compared to 80% now. Disposables are now the most popular product amongst youth vapers.
However, nicotine use amongst 18yr olds has been stable in the last 2 years - disposables haven’t caused an increase in nicotine use.
There has been a rise in vaping overall - almost doubling in 18yr olds. [There appears to be a contradiction here which I don't fully understand.] Yet at the same time smoking has dropped more in 18yr olds than in any other age group, showing that they are using e-cigarettes instead of smoking.
Many more 18yr olds are now vaping/dual using than smoking, and cigarette use has dropped most rapidly amongst age groups where vaping is more popular.
There have been negative environmental concerns - with the waste and litter caused by disposable vape batteries leading to calls for regulation.
Why are disposables so popular?
- Cost: Younger people have less disposable income so prefer the lower price to a reusable (although in the long term this is more expensive).
- Convenience: They are easier to use than reusable devices.
- Nic hit: Disposables deliver nicotine in a palatable way.
- Availability: Disposables are very available in all kinds of shops and seem to be getting cheaper. Also, youths find them easy to access underage.
- Advertising: Disposables are being advertised through traditional and organic marketing as well as sponsorships. They are very prevalent on social media.
These reasons are similar to those that caused the popularity of cigarettes.
While this data shows stable nicotine use in the UK, other data has shown a potential rise in youth nicotine use - however, this is usually alongside drops in smoking. This makes us wonder what we want to accept. Would we want lower smoking but higher nicotine use? Or higher smoking and lower nicotine use?
Disposables could potentially be catastrophic for public perceptions of vaping - because of their attractiveness to young people and their environmental impact.
As we’ve seen, things can change so quickly so it’s very important to keep tracking usage.
The impact of policy changes, that are designed to protect young people, on smokers and vapers
Dr Jasmine Khouja, Senior Research Associate
Jasmine started by looking at negative news stories, and some of the causes - lack of certainty over long-term harms, fears of a gateway to smoking e.t.c. This has led to calls for bans on flavours.
But we can see what has happened as this has happened elsewhere. In San Francisco, a ban on flavours led to an increase in smoking, while in Norway it led to a massive increase in black market sales of vaping products. Overall, the benefits of banning flavours seem to be outweighed by the negative consequences.
Jasmine asked a group of 12 smokers and 12 vapers what they would do if flavours were/had been banned. 33% said they would not be/have been successful in quitting, while 50% thought their quit attempt would have failed. Some felt they would have quit successfully, but then reverted back to smoking.
The same group also then tried unflavoured e-liquids, and shared their thoughts in interviews. Some vapers said they would not have quit, or that they might have quit but would go back to smoking. Indeed, some existing vapers also said they would revert to smoking.
The same group also suggested alternative policies to banning flavours. Ironically, many of these suggestions are already in place (e.g. enforcing age verification in shops and online) but are not strictly enforced, especially online.
There were also suggestions that are not already in place, such as implementing a minimum purchase price - but it would be important that these should not be too high, as cost was important to the interviewees. [I question the value of including these suggestions without also including thoughts on their consequences. For example, the minimum price suggestion would put black market sellers at an even bigger advantage, and would clearly disadvantage the poorest and most vulnerable smokers in society.]
In conclusion, Jasmine argued that policies must continue to help smokers and vapers. Policies should also discourage young people from using vaping devices, but we need to carefully consider their consequences.
Listening to young smokers and vapers talking about disposables
Dr Frances Thirlway, Research Fellow - Sociology Department, University of York
Dr Thirlway has spent 5 months speaking to smokers, vapers and vape shop workers across the UK - with 50 participants, 30 of whom were disposable users.
Key findings and discussions
- Most smokers/ex smokers had smoking parents.
- The average age of starting smoking was 14/15 years old, some started as young as 11 or 12.
- Most were smoking for 4 years, on average, before trying vaping.
- The subjects reported little problem buying either tobacco or vape devices at a young age.
- Flavour was the no 1 reason for using disposables as well as convenience.
- Many people are confused around what a 2% nic strength means - not realising this is a high amount.
- The 2% nicotine strength has caused a barrier to switching from disposables to reusables. When using a reusable device, many found a 2% freebase e-liquid was too harsh.
- Vape shop workers reported some interest in lower-nicotine options amongst casual users who wanted to use them socially.
- Only 2 of the 50 had never smoked. One 16y/o reported taking it up rather than start smoking.
- Disposables are not just for young people - only 2 of the participants used novelty disposables and they were in their 30’s.
- Some participants see disposables as a ‘trend’ and reported being influenced to use them by friends and social media posts.
- The cost of disposables is a big issue, particularly amongst these subjects - with 2 Elf Bars a day costing £70 per week. Many were keen to switch to reusable devices but had issues with them. Vape shop workers reported trying to get people to switch but many vapers felt disposables were just easier.
- One participant who was dual using felt that vaping may not be safer and that there wasn’t enough research on this. As a result, they were considering giving up vaping and sticking to just smoking.
Frances concluded that we need to shift misconceptions by giving people the information they need. People making decisions about their lives need to be given the best advice we can give them.
Maximising existing opportunities to reduce health inequalities
Dr Sharon Cox, Senior Research Fellow
Sharon Cox works with inclusion health, which means working with people in extremely vulnerable groups including the homeless, substance abusers and victims of modern slavery - although there is often an overlap between the groups.
Smoking rates are extremely high among these groups - rising to 90% with opioid users. These people have short, hard lives, with women, for example, 12 times more likely to die younger than the average. A third of deaths could have been prevented by access to timely health care.
Yet there is a perception that these people won’t change their behaviour, and therefore there is little effort to help them quit smoking - just 3% of people in these groups had been offered access to smoking cessation programs. Yet it is among these groups where the problem is concentrated the most and the help is most needed. These people also engage in risky behaviour around smoking, such as picking up fag ends, stealing or exchanging sexual acts for cigarettes.
Sharon discussed a study which introduced vaping to smokers at a homeless centre. This ran into a lot of opposition. Opponents feared people wouldn’t stick with programs, would sell their devices, and would use illicit substances. None of this came to pass.
Sharon is particularly interested in some of the less talked about benefits of using vaping in these groups. For example, people at an alcohol and drug centre who were introduced to vaping dramatically reduced the amount of cigarettes they smoked, but were also less likely to engage in risky behaviours around smoking such as picking up fag ends or sharing cigarettes.
Illusions, delusions, and a few conclusions
Clive Bates, Director - Counterfactual Consulting Ltd
People like nicotine (SHOCK!)
Clive recounts some findings on the benefits of nicotine: It produces rewarding psychoactive effects, stimulation, & pleasure, reduces stress and anxiety and is valuable for mood control in some people. It helps with cognitive performance, enhances memory, and could be beneficial for those with ADHD or schizophrenia.
So some people find nicotine beneficial, even if it turns into dependence.
The disappearing deterrent
Tobacco Control has spent years warning people of the harms of smoking - harm is the currency of tobacco control and plays a major role in suppressing demand and use of tobacco. We know that smoke-free products are much less harmful - but what does this mean for the deterrent? Where is the deterrent to using nicotine if there’s such a small risk?
Harm is playing a major role in suppressing the demand for nicotine - because it’s in the form of cigarettes. Policies controlling the use of products are predicated on harm - justified by and based on the burden of disease.
Clive thinks that the suppression of nicotine use by the costs and burdens of harm will be lifted, and we may see more nicotine use in society over time.
There is a harm story in most definitions of addiction. The official definition states that addiction is: “…where the behaviour results in risk or occurrence of serious harm.” The reason we stress harm is to limit a class of things that merit treatment and public health response. We should take care when using stigmatising labels.
Clive believes nicotine should join other socially acceptable psychoactive substances (caffeine, moderate alcohol etc). There is no compelling objection to the use of nicotine as long as it is not physically, psychologically or socially harmful.
Nicotine and adolescents
To better understand moral panic around youth vaping we can split it into infrequent and frequent vapers.
Infrequent vaping is much lower - those who do it because its ‘a laugh’, a fad or because celebrities are doing it etc. Frequent vaping is probably more beneficial because it's displacing smoking.
So although there’s panic around youth vaping, the uses are either inconsequential (infrequent vaping) or beneficial (frequent vaping).
Is nicotine only for former smokers?
Clive points out negative quotes about never-smokers taking up vaping, but questions whether these people would rather them smoke first? Children have always done as adults do. Instead of being worried about youth vaping, should we not just pocket the win from the declining smoking rates?
Vaping is way down the list of things that are troubling young people.
“We need to come to terms with nicotine as a recreational drug in society, irrespective of smoking - as a socially acceptable stimulant that people like to use.”
Industry, Regulation and Public Health
PHE, OHID and Tobacco control in England
Rosanna O’Connor, Director, Addictions & Inclusion, Office for Health Improvement & Disparities, Department of Health and Social Care
Rosanna takes us through what the Office for Health Improvement & Disparities (OHID) has achieved in their first year. She notes this is against the backdrop of the lowest-ever smoking rates in England, with the challenge of trying to maintain interest in tobacco control against these stats.
OHID has 2 main objectives for vaping:
- Maximising switching opportunities:
- Preventing non smokers and youth from smoking:
NCSCT Guidance published in November 2021:
NICE (National Institute for Health and Care Excellence) & OHID held different positions at first but OHID has been able to support NICE in putting together and publishing this guidance. This is very important in giving clear advice, having first-line treatment and working with the ‘doubters’ in public health. An example of clear guidance is that provided by the NCSCT (National Centre for Smoking Cessation and Training).
The Khan review, published June 2022
OHID contacted Javid Khan. He originally knew nothing about the evidence or Stop Smoking Services, and was not a smoker, but became a champion of e-cigarettes and how they can help, particularly in high-smoking populations.
Khan encouraged the release of accurate information, including a Vaping Facts website similar to that in New Zealand, and pushed for the NHS to supply e-cigarettes.
Nicotine Vaping in England report: September 2022.
Rosanna briefly touched on the Nicotine Vaping in England report, a large, evidence based report that has been years in the making.
What’s next for OHID?
The organisation has very ambitious plans. Only small numbers of SSS (Stop Smoking Services) are using vapes and OHID is hoping to turn this around.
Avoiding missteps in nicotine regulation: what can we learn from patterns of nicotine intake from cigarettes?
Prof Martin Jarvis, Emeritus Professor of Health Psychology, Department of Behavioural Science & Health, University College London
It is the users, not the products, that determine the dose. This is a key issue, one that is misunderstood and leads regulators in to dead ends. Cigarettes are elastic nicotine devices, able to satisfy different kinds of users, such as those who smoke for pleasure and those who smoke to maintain nicotine levels in their blood and avoid withdrawal symptoms.
Evidence has shown that people using different nicotine types (cigarettes, snus and snuff) obtain almost exactly the same amount of nicotine. People using different nicotine strength cigarettes get the same amount of nicotine. It’s even the case that people who smoke fewer cigarettes e.g. 10 instead of 20, get the same amount of nicotine. This is because smokers self titrate (i.e. they control the amount of nicotine they get from each cigarette).
With tobacco forming the vast part of the market, we have a mountain to climb if we are to eliminate smoking (i.e. achieve less than 5% prevalence). That’s particularly the case as history has shown that products with insufficient nicotine will fail.
That means there is scope for poor outcomes if policymakers constrain the amount of nicotine that can be obtained from non-combustible e-cigarettes. For example, 76% of people who failed to switch to vaping said it was because the experience was not satisfying. [Note that in the EU and UK the nicotine level is constrained to a maximum of 2mg per ml.]
"The imposition of limits on nicotine by regulators could mark a fresh chapter in the long history of own goals in tobacco control.”
The achievability of a UK medicinal licence
David Graham, Chief Impact Officer, NJOY
David’s company is pursuing a medicinal application for their vaping product in the UK.
There is long-standing governmental and non-governmental support for a medicinal licence for e-cigarettes. It will help reduce smoking rates, assist with 2030 Smoke Free targets and improve public health. But it’s not really about either of these things - it’s about improving choice and access.
Some people (including vapers) think smokers don’t need treatment. But not all people who smoke are alike, people are different and one approach doesn’t fit all. The opportunity is not to switch vapers from one product to another but to offer a broader choice and range of options.
“There is no point in having a highly effective product that no one uses or a product that people use that is completely ineffective.”
Expanding choice (with both medicinal and consumer products) would give greater reach and impact. There is also a need for greater confidence and trust in information, such as from healthcare professionals and Stop Smoking Services. We need to engage healthcare professionals who are on the fence - this can help with misinformation.
Is a medicinal license achievable? The medicinal regulatory framework is like a walled garden - only accessible to a privileged few who have the key. The wall has been high for a long time and it’s unclear how to get over it. Some want to keep the wall up, some want to bring it down. However, there has been some progress, for example with updated MHRA guidance and new Committee of Toxicology findings.
‘Threading the needle’
We need to take impact into account and also make sure that the products are approvable - safe, efficient and high quality. We must find the balance between an approvable product that also has an impact.
Who would have thought we’d be talking about disposable e-cigarettes at the tenth edition of the London E-Cigarette Summit?
Liam Humberstone, Technical Director at Totally Wicked, IBVTA
Liam started by covering the difficulties the vaping industry has undergone, starting with EVALI and Covid (which meant all vape shops were closed for months). These were disastrous for the sector, and for the first time in years, the number of vapers declined.
However, the convenience sector grew, and this got some people thinking. These people developed a device that was fundamentally the same as original disposable devices but with a much more concentrated flavour, improved battery capacity and increased e-liquid capacity. These took off - which makes sense. Previously, we’d been trying to sell smokers devices which were difficult to use and difficult to maintain - and just didn’t work for many smokers.
This came with aggressive social media marketing, as the marketers were from outside the UK and not constrained by our laws - but the consumer demand it met was real, and the products would not have worked if they had not been good. The growth was huge - disposable sales rose from 10 million GBP in 2020 to 650 million GBP in 2022.
Is this a youth issue? Age verification data from Liam’s websites show that the average age of a disposable vaper is in the 40s. Disposables are most popular with the 31 - 35 group. Flavours are popular in older groups too - for example, over 75s really like Blue Razz Lemonade and Cotton Candy Ice.
What does this mean for smoking? Tobacco is dying a death in most groups. And this means that people are grabbing a disposable instead of a 20 pack of Lambert and Butler when they go out clubbing.Liam concluded with a plea not to ban disposables. The IBVTA (Independent British Vape Trade Association) is providing intelligence to Trading standards, Liam is working on new devices which will help switch vapers away from disposables - but the most important thing to remember is that priority is to stop smoking. After all, “you don’t clean your kitchen while your house is on fire.”
E-cigarette legislation in Ireland. The good, the bad and the ugly
Dr Garrett McGovern, GP and Medical Director, Priority Medical Clinic
Countries that embrace vaping are doing better at reducing smoking rates. Garrett pointed to Australia as an example of a country where a war on vaping is being waged and stop-smoking progress has halted. Ireland has made some progress, but this has been slow (in fact smoking prevalence actually increased last year) and the 'smoke free' year keeps being moved back as a result - it’s now set to 2037.
That's no surprise given the whirlwind tour Matt took us on of social media, media and government reaction. The government has no ban on selling vapes to children but thinks vapes should be restricted for everyone because of the gateway fear. (1% of non-smoking youths in Ireland vape). They were even considering a ban on flavours before putting a youth smoking ban in place.
Doctors have told smokers there is no point in using e-cigarettes, and the Irish National Health Service does not recommend them as an option for smokers. It was all rather depressing.
THR, Nicotine & End Game
A conceptual model for measuring and understanding the possible role of alternative nicotine products and policies for reducing smoking
Prof Geoffrey T. Fong, OC, Ph.D., FRSC, FCAHS, Founder and Chief Principal Investigator of the International Tobacco Control Policy Evaluation Project, Professor of Psychology and Public Health and Health Systems, University of Waterloo
Unfortunately, I missed the start of this presentation, and then Professor Fong went through his slides so fast I didn’t have time to screenshot all of them. I joined as Fong talked about price elasticity, and how the price of one product affects demand for another product. Fong then extrapolated this to policies. Restrictive policies can reduce demand or switch it to another product. Ben concluded that restrictive policies have helped to reduce cigarette consumption, but there are not enough examples of enabling policies to know if the opposite works for e-cigarettes.
Fong then went on to laud the WHO FCTC attempt to reduce smoking. The initial treaty led to restrictive policies on smoking, but not enough - with many countries failing to implement policies. A new attempt is now underway to encourage more countries to enforce FTCT policies such as high taxes and warnings on cigarette packs.
He also pointed out that a menthol ban had reduced the menthol smoking rate in Canada by 7%. If this was extrapolated to the US, this would lead to 1.3 million smokers quitting. “How many smokers would have to take up vaping to achieve the same gain?” he asked. [I assume the answer would be 1.3 million! According to Gallup, 8% of Americans have vaped in the past week, which would be around 26 million, albeit this does not mean regular usage.}
New Zealand’s tobacco endgame polices: Cause to celebrate, or harmful folly?
Ben Youdan, Director, Youdan Consulting - New Zealand
Ben Youdan started off by talking about how the e-cig summit, and his visit several years ago, and how it had fed into knowledge and actions in New Zealand. New Zealand has a history of aggressive tobacco control, but also of interest and research into harm reduction, with some of the first research into vaping taking place in the country,
New Zealand has an interesting policy on vaping. They have restricted advertising but have been open about the relative harms. Only closed devices and limited flavours are allowed in most shops, while vape shops can sell a variety of devices and flavours. It’s working. Vaping is rising and is mirrored by a dramatic fall in smoking rates, especially amongst the Mauri.
But harm reduction is about to be married to a draconian tobacco endgame policy which includes removing nicotine from cigarettes and cutting the number of shops that can sell cigarettes from around 6000 to 600.
What’s wrong with this? First, the policy is not needed. New Zealand is already on track to reach its goal - even slightly ahead. Youth smoking is almost non-existent. Yet in the future, when other countries look to why New Zealand is successful, the danger is that they will point to the non-vape policies. In fact, this is already happening in Australia, which is pointing to New Zealand's success and seeing demands to follow it. Yet the steps they want to take ignore vaping and focus on steps such as relaunching plain packaging.
We also need to think about the people who still smoke. A huge proportion of these are Mauri. The Mauri population already face disproportionate criminal charges over cannabis use - not because they use it more, but because of systemic racism. Introducing new criminal charges around smoking is likely to further penalise Mauri people.
The state of the harm reduction debate in the United States
Mitch Zeller, J.D Director (Retired) Center for Tobacco Products (CTP) - The Food & Drug Administration (FDA)
Mitch sums up the Tobacco Harm Reduction (THR) debate in the US: “Not good!”
E-cigarettes provide nicotine without tobacco and combustion - and are driving the Harm Reduction debate in the US. They are forcing policy makers to acknowledge there is a continuum of risk, and that there are more harmful and less harmful ways to deliver nicotine.
A smoker who switches will absolutely reduce risk. Smokers smoke for the nicotine but die from the tar. There is a public health opportunity to move smokers to less harmful products.
However, the debate is incredibly divisive in both Tobacco Control & Public Health circles. Most would keep the debate black and white with the pros and cons of e-cigarettes, which is causing anger and a stalemate.
The strategic dialogue on THR:
26 thought leaders in the US (including Mitch), with diverse viewpoints (pro, anti and middle) met 4 times from 2005 - 2007 to discuss THR. In 2009 they produced a consensus paper acknowledging the continuum of risk was real and provided principles and recommendations to drive research, policy and communication.
They concluded that if there comes a time when no one is smoking there has to be an alternative, less harmful product available.
Premarket review: A congress review of new markets and new claims was imposed. The standards were set that the marketing must be appropriate for the protection of public health and be on a case-by-case study of individual products. The review states that any benefits to adults should outweigh risks to youth.
This affected the debate when e-cigarettes came to prominence. Nicotine doesn’t have to cause cancer and disease associated with tobacco. Of course, there are still concerns around addiction, youth vaping, flavours etc that make the debate more complicated.
There are inconvenient truths for both sides of the debate. While there are those against vaping products - there are smokeless, heated e-cigarettes that have met the APPH standard and gained marketing authorisation. On the other side there are flavoured products that have failed to pass the APPH test - as the case for benefits was not made.
Reframing the debate: Is there a common policy ground that can be reached? Can we create a world where combustibles no longer create or sustain addiction? The FDA has the statutory authority to do this and the science supports this.
The modelling projections show that over 33 million Americans who would have become smokers wouldn’t - resulting in an adult smoking rate of just 1.5% and 8 million deaths tobacco-related deaths could be avoided. But there are still 30 million current smokers in the US who will seek nicotine and need a way to access them.
Is the US Tobacco Control field ready to ask tough questions?
“What is the endgame? - A tobacco-free or tobacco and nicotine-free world?”
Mitch ends by stating that he is envious of the state of the UK’s harm reduction environment and the alignment between the regulator and advocacy community. He tries to remain optimistic for the US, which does not have this - although he hopes this can change.
Nicotine and tobacco control in LMIC
Associate Prof Sivakumar Thurairajasingam, Associate Professor in Psychiatry, Head of the Clinical School Johor Bahru, Monash University Malaysia
Smoking is huge in LMIC (Low and Middle Income Countries), which contain 80% of the world’s one billion smokers. It is particularly high amongst boys, where smoking rates can reach 46%, and is mostly found amongst less educated, lower-income people.
What about WHO FTC policies? There’s actually been an inverse relationship between introducing FTC policies and smoking cessation. This may be because of poor policy implementation. But it’s also because the government has failed to embrace tobacco harm reduction. A combination of bans on safer nicotine products, misinformation and sensational media coverage have all contributed to reduced use of tobacco harm reduction products.
Electronic cigarette usage may be low in Malaysia, but it’s encouraging that people are using it for the right reasons - to quit smoking.
Will things change? A majority of the population support a tobacco harm reduction policy - but the problem is with the policymakers. However, if and when there is a policy, this needs to take into account each country’s unique circumstances - blindly copying other countries' policies will not work.
When the end game is not the end – the new battle lines in Norway
Dr Karl E. Lund, Senior Researcher, Norwegian Institute of Public Health
For most of the world, the debate on smoking is how to get to the end game (less than 5% smoking prevalence rates). Norway is fortunate enough to have pretty much achieved this, with tobacco smoking approaching 5% and likely to be eradicated in the next one to two decades.
Why? The tobacco control community will tell you it is because of tobacco control. But policies such as high taxes started in the 70’s and the decline in smoking didn’t start until the 90s - which was the same time Snus (a reduced risk oral tobacco product) entered the market. The impact can be seen in Sweden too, where tobacco related deaths are now half those in other EU countries.
Unfortunately, it’s difficult for the tobacco control community to accept that the regulations they have spent their lives fighting for are not what is responsible for reducing smoking rates.
What next? Now the authorities are considering going after other reduced nicotine products, because they don’t see the point of them once smoking has been defeated and to pursue the ultimate goal of a nicotine free society.
Carl covers both sides of the debate, which is perhaps best summarised by his slides:
Karl concluded that with smoking eliminated, risk reduction arguments in favour of Snus will not succeed. But arguments in favour of consumer rights just might legitimise the future of the product.
The UK government’s approach to e-cigarettes
Deborah Arnott, Chief Executive, Action on Smoking and Health
Deborah started off by reminding people about the threat of the tobacco industry. We can’t let the tobacco industry off the hook or ignore the risks of industry interference. The interests of the tobacco industry have always continued to affect policy.
Yes, it’s not just Big Tobacco that can’t be trusted. But it’s a matter of scale - smoking killed almost 10 million between 2009-2019, a figure only matched by the fossil fuel industry.
Deborah touched on the first e-cigarette summit, when some, including her, thought the only route was medicalisation. This wasn’t the right policy solution, and policymakers understand this now. However, it doesn’t mean there isn’t room for a medical e-cigarette device.
E-cigarettes work. We know this both from RCTs and from a population level. However, it doesn’t work in all countries e.g. Italy, Switzerland, and Greece. These are all countries that have yet to implement best practice tobacco control. [Note also, though, that Italy and Greece have both implemented as taxes on vaping.]
E_Cigarettes may work, but they are not a magic bullet - just another tool. At the same time, there are real issues which can’t be ignored. Youth vaping is on the rise, as is long-term vaping. There are lots of questions that need answering, such as what are the long-term risks of vaping? Telling vapers we don’t know is not good enough.
Deborah finished off by thanking Amanda for fostering respectful debate - at a time when it is needed more than ever.