In Sweden, the combination of snus and the emergence and uptake of pouches were likely key to its unparalleled achievement of smoke-free status, in November 2024. Despite these positive signs, regulators are circling, particularly in Europe, with bans either in force or planned in several member states. The panel will explore the science and evidence for pouches and discuss what steps need to be implemented to ensure proportionate and effective regulation.
Transcription:
00:11 - 06:32
[Martin Cullip]
Hello, everyone. It's just gone four o'clock, so I'm going to start, even though people are still coming in. I hope they can pick up what we've been talking about. Anyway, my name is Martin Cullip. I'm a former smoker. I'm a consumer advocate. I use nicotine products. I vape and I use nicotine pouches. And I'm currently a contractor with the Taxpayers Protection Alliance in Washington, D.C. So I'll be your host today. I just want to start off talking about something that happened. People who've come to this event might remember from 2017. Ethan Nadelmann delivered the Michael Russell oration back then. and he comes from a drugs background and he compared nicotine use with drug use back then and he said we're on easy street here because when you're talking about drugs it's completely different whereas you can just you know you can use nicotine openly millions of people do it and then we're not traumatized by that but what a difference we have now where nicotine is now being demonized more and more so just in the last seven or eight years the whole situation has changed um We're now seeing some countries like France, Netherlands, Belgium, talking about banning nicotine pouches, and they're attacking them. The UK government is now saying they're going to bring in regulations on pouches. And there's a different regulatory landscape around the world with the USA, obviously Australia, and other countries as well. So we're going to talk about pouches. I want to talk first about the fact that some countries are banning these products. Now, this seems to me to go against... The Harm Principle, which was exposed by J.S. Mill in 1859. And he says on restricting products which are only harmful to one person, that the only purpose for which power can be rightfully exercised over any member of a civilised community against his will is to prevent harm to others. His own good, either physical or moral, is not a sufficient warrant. And he talks specifically about restricting access to these products that is only suited to a state of society... in which the labouring classes are avowedly treated as children and savages. So we have these countries now banning products that are far less harmful, but it's important to realise that cigarettes are legally available in every single country in the world. There's not a single restriction anywhere. They do talk about how Pouches could be dangerous for children and that's definitely a concern. But it seems to me that using that is really blaming the products for the problems rather than the regulations on the products. We don't do that with other age-gated products. And I just want to leave you with a lesson I saw in April in the New Yorker because there's still this controversy about pouches in America. And it was from a guy called Robert Bailey, who's a clinical psychologist from Seattle, Washington State. And he said in this letter, smoking is still, in 2025, the leading cause of preventable mortality and morbidity in America. In a broader context, if you were to regularly drive a motor vehicle, walk on city sidewalks, or ride a bike, you would almost certainly be putting yourself at more risk than you would be by popping in a Zin pouch. Smokers would be wise to consider the switch safe. So a clinical psychologist said that, not me, but it was an interesting letter. So we're going to introduce the panel here. We've got some people who know about nicotine pouches more than me as a user. So I will introduce them to you. We'll start on my left here. We have Anna Franson, who holds an MSc in Pharmaceutical Biosciences and a PhD in Toxicology from Uppsala University, Sweden. With over 20 years experience in the pharmaceutical industry and regulatory environments such as the Swedish Medical Products Agency, Anna has developed a deep expertise in risk assessment, clinical research and regulatory strategies. She has also worked extensively in the industry academic collaborations, excuse me, supporting the development of innovative healthcare solutions. Anna joined EmpliCure in 2021 and leads the company's regulatory strategy. Passionate about innovation and safety, she is dedicated to advancing novel solutions for nicotine and drug delivery. So welcome, Anna. Mark Oates, on my far left, is the director of We Vape and the Snooze Users Association in the UK, which are both consumer groups standing up for the right of individuals to use safer nicotine products. He advocates for evidence-based harm reduction in a range of areas, from tobacco to drug policy, a subject he has written on for the Institute of Economic Affairs and the Adam Smith Institute, where he is a fellow. He's also provided consumer evidence in the 2018 ECJ case to overturn the ban of snus across the European Union when he was a parliamentary researcher to an MP. Cecilia Kinstrand is an editorial director... Sorry, has spent the last 15 years working for Swedish Match in Brussels, a company with tobacco harm reduction at the core of its business. She predominantly focused on EU regulatory matters, especially the TPD 2014-40, the legislation banning the proof of concept of tobacco harm reduction in 26 of the 27 member states. Since PMI's acquisition of Swedish Match, she now represents PMI. The focus of her work remains the same. And lastly, Barnaby Page, editorial director of Tamarind Intelligence, the publisher of e-cig intelligence, tobacco intelligence, and can intelligence. As a journalist, he has been covering the worldwide reduced-risk nicotine sector since 2014, with a particular focus on public health and regulatory issues. In his current role, he manages Tamarin's editorial and reporting teams, producing a wide range of nicotine-related content. He's been participating in the Global Forum on Nicotine since its inception. Before coming into this field, Barnaby spent 30 years as a reporter and editor for newspapers, magazines, and online services, specialising in technology and business, and is based near London. So welcome to everyone. I want to start with you, Barnaby, because you can maybe explain...
06:33 - 11:52
[Barnaby Page]
market as it is for pouches at the moment before we get into the more technical matters sure yeah i'll try to give a quick overview well i think it um it may surprise a lot of people to know that nicotine pouches have been around um a lot longer than we generally think um xin in fact will be 10 years old next year um so it's much the same age as the global forum on nicotine which is which is slightly older than 10. um but of course it's only really in the last two three years that they have really rocketed into the public consciousness. You know, having been pretty much niche products for a long time, familiar to users, familiar to consumers, and familiar to some people in THR. But really, until a few years ago, completely off the radar of regulators and policy makers and the media as well. That is now changing, of course, very rapidly, and I think one of the things I will probably come back to in today's session is the question of whether we are now going to have a pouch moral panic as we did have a vape moral panic a decade or so ago. But just to give you a very quick idea of the pouch market and how it is regulated, I'm certainly not going to go country by country. Our estimates at Tamarind are that the market is currently worth about $7.5 billion annually. That's roughly, roughly speaking, a quarter of the size of the vape market or the heated tobacco market. So it's still pretty small in comparison with those. But the significant thing is it is growing very, very, very quickly. Barclays, in fact, in a recent report, forecast a quite astonishing 1,000% growth over the next 10 years. I don't know that we go quite that far, and they're actually starting from a slightly higher base than us. But we're certainly looking at that kind of escalation in market size that, again, parallels what we saw with vape in the early days. In terms of the market structure, a couple of things are worth noting. One is that, and much of this will be familiar to many people in this room, of course, one is that, unlike the vape sector, the pounce market is... pretty much dominated by the big tobacco players. Another one which perhaps is less obvious is that while the vape sector online purchasing, online shopping is a pretty important channel, pouch users interestingly are very, very much more enthusiastic about face-to-face purchases. So it's much more dominated by bricks and mortar retail stores. We can speculate as to the reason for that, but it's sort of interesting quirk of the market. And so then the question of regulation, well I think the one thing we can say with certainty about pouch regulation is that the story isn't over yet. It's in a state of flux right at the moment. In a lot of countries, I mean if you look at Europe for example, you have a big split with many countries currently regulating pouches basically as any other consumer product, while there's a sort of strip of countries in Central and Eastern Europe and also in the Nordic nations that regulate them as tobacco products. So once again, it's looking very like the vape market did, you know, perhaps 10 or a little less years ago. But we have a lot of moves afoot to change that. People will know about the bands that already exist in Belgium and the Netherlands, Lithuania as well. We have a proposal to ban pouches in France, as well as, I think, three counter proposals to regulate them. There are talks about reducing nicotine limits to effectively ban levels in Spain. And then looking further afield, of course, there are countries like Canada where pouches are classified as pharmaceutical products. Australia, ditto, although there it's a kind of notional classification because nobody actually has a license to produce them. And then you have countries without outright bans, as sort of mentioned, I think, Belgium, the Netherlands, Russia, Brazil, Argentina, for example. And finally, just as an example of the complexity of how this product could be regulated, you have the very old case in Germany where pouches are treated as foods, they're treated as novel foods under EU regulation, so you would need authorisation for them as a novel foodstuff to sell them legally. Needless to add, that hasn't been forthcoming. I won't talk about tax at length. I think it's just worth noting because it's probably a thing that has come up or will come up elsewhere in the conference. There's been, again, yet another recently leaked EU proposal for taxes on nicotine and tobacco products generally in the past couple of weeks, which would see a very heavy tax rate go on to pouches, about 40-50% of the retail price. So... I'm afraid I don't have a single takeaway from that, except that the situation is pretty mixed. The direction of travel is not necessarily an entirely positive one. People are more talking about prohibiting pouches than about liberalising the market. But certainly nothing is resolved yet. So I'm sure a great deal to talk about in that context. Anyway, I've probably spoken enough now.
11:53 - 12:11
[Martin Cullip]
I want to ask you one quick question, because you touched on a number of, jurisdictions there. What do you make of what's happening in America? Because it's almost become political in America, isn't it? And there's a big rise in products. We have the FDA has given MRTP or FDA orders to it. What's going on there?
12:11 - 14:09
[Barnaby Page]
That is an interesting question. In fact, thank you for reminding me, because I meant to mention the US in the excitement of talking about Germany's novel food. The biggest market in the world. Completely slipped my mind. Yes, I mean the US of course is a curious situation because we all know it has the PMTA system exactly the same as applies to e-cigarettes or indeed to combustibles. Also applies to pouches. We all know that system doesn't work terribly well. Its dysfunctionality is less obvious in the world of pouch simply because you don't have tens of millions of applications of pouch products. Now, the FDA has, of course, approved the Zin product for sale, so that's legally on sale. And there's now an application that's gone in for modified risk status for Zin, which, if granted, would allow essentially statements, formal statements on packaging, et cetera, that the product is less harmful than others. That would be quite a coup if it is granted. It was granted, of course, before the Swedish match snoozed. In fact, it's been granted to ICOS, the heated tobacco product. That seems to have been largely forgotten. So in a sense, the US market is actually a more officially tolerant one for pouts than many other markets are. What we do have in the US at the same time, I think we have signs... signs of the potential emergence of a nicotine-naive consumer market for pouches rather than simply a substitute, an off-ramp smoking, which is precisely the kind of thing that, of course, is going to get regulators and the public health establishment worried. So that's the downside in the U.S. So the bottom line there is U.S. less vehement in opposition at the moment, but I think the makings for future opposition and panic are certainly there.
14:09 - 14:20
[Martin Cullip]
14:21
14:11 - 19:45
[Anna Franzen]
Well, yes, so with a background as a toxicologist, I was asked to offer more of a risk management perspective of this. And I considered starting with letting you know the well-known that more than 8 million people die every year from tobacco use. The links to lung cancer, heart disease, and COPD, or or maybe just walk you through the toxicity profile of tobacco smoke with carbon monoxide, tar, and more than 50 known carcinogenes. But all of this you already know. And then I thought I would highlight Sweden, where the daily smoking rates has dropped below 5%. This is one of the lowest, if not the lowest, in the world. And according to the WHO, the definition of a non-smoking country. So that is really a remarkable published health achievement, with a Swedish snus being one of the parameters for that. But again, I think that is familiar territory for you. So because the risks and consequences of tobacco smoking, they are extremely well known. So what I think really matters now is how we manage these risks. And risk management, that is really the process of identifying, assessing, and prioritizing risks. And really taking actions to minimize harm and This is like the core framework in any assessment of the public health. And also I think it's a driving force for innovations from the safety belt to vaccines or even the innovation of the bioceramic nicotine pouches that I stand for. So the goal here is really not to eliminate all risk because that is rarely achievable, but to manage the risks well. for the greatest possible public health gains. So that, I think, I mean, we all can agree upon that is the goal. And in this case, we need to make an important distinction between nicotine in itself and the hundreds of toxicants that are included in tobacco smoke. So, and I sometimes hear this statement that we lack long-term studies on nicotine. I would say that this is a misunderstanding. In fact, nicotine has been available on the market as a medicinal drug for smoking cessation for more than 40 years. Nicotine replacement therapy has been, it is, approved by regulatory authorities. It is recommended by physicians. And it has been used safely for decades. So when nicotine is separated from tobacco and combustion, the risk profile dramatically decreases, both short-term and long-term. So, I mean, this we know. So for a risk-benefit assessment, it's also essential to consider the dose-response relationship and exposure. And that said, I think it's important that we need to ensure that the nicotine levels and the delivery profile in nicotine pouches, that they are appropriately balanced. So on one side, they need to drive the transition from tobacco smoking And on the other side, they shouldn't be so high as to increase any potential for unintended consequences. So I would say that with all the science and evidence knowledge that we have, along with new innovations within this category, we are very well positioned to support policymakers in making informed regulatory decisions. And I think that these regulatory strategies really should acknowledge the needs of the intended users while also, of course, safeguarding the underage use. And I also think it's important that if we only have a fraction of the 1.1 billion tobacco smokers worldwide, if they switch to nicotine alternatives, I mean, the public health gain would really be profound. and millions of lives extended and population health improved. And with that, the economic benefits would, of course, naturally follow as well, reducing, I just read, the estimated global cost attributed to tobacco smoking is about 1.4 trillion US dollars. So... So really from a toxicology and risk management perspective, nicotine pouches represents a highly effective intervention, eliminating the exposure to the most harmful aspects of tobacco use, which is combustion. So in that sense, I think the science is clear. So given the favorable risk benefit profile of nicotine purchase, these consumer products definitely have an important role in advancing the public health.
19:47 - 20:34
[Martin Cullip]
I want to ask you a question which may be a bit frivolous, I suppose. I went to Sweden last year and I spoke to Swedish people because I'd never seen, I've heard about Sweden, I've written about it, but I was there for four days, I think. I saw one person smoking a cigarette. And you go into the bars. I think there was a football competition at the time. I don't know what it was. I'm not a football fan. And you just saw people sitting there. And you saw no cigarette packets. You just saw cans of pouches or snooze. And we know what happened to Sweden. But talking to Swedish people, they don't know that we talk about them. I said, we talk about Sweden all the time. And they said, we didn't know why. But what are we doing so different? They just don't know. So why does the rest of the world kind of ignore what Sweden's doing? And the results from Sweden, which seemed... undeniably good from public health?
20:34 - 21:29
[Anna Franzen]
Well, that's a hard question, but one reason might be that we are, the Swedes, hasn't been, I mean, we have forgotten that we are unique in this way, and we have forgotten that in Sweden we used to smoke. We have normalized that we don't smoke anymore. So I think that is one big reason, and I also think that, I mean, until just recently, the Swedish government hasn't talked about about this, but now they're starting to do that regarding both France and Spain, I think, and they are really telling the message that the use of both Swedish snus and nicotine pouches is one reason that we have so low smoking levels, but also a reason why we have so low prevalence of lung cancer, because the Swedish snus has been around for so long time, so we can do that kind of research.
21:30 - 21:35
[Martin Cullip]
It was about 200 years they've used snus in Sweden, something like that?
21:35 - 21:37
[Anna Franzen]
Perhaps, if you say so.
21:38 - 21:49
[Martin Cullip]
OK, thanks. Mark, you're a consumer like me, a very enthusiastic consumer, as I know. Do you want to give us a talk about what your experiences are with consumer use of snus?
21:49 - 21:49
[Mark Oates]
Yes.
21:49 - 21:51
[Martin Cullip]
And pouches, sorry.
21:51 - 26:06
[Mark Oates]
So I quit smoking through a combination of snus and vaping, but I was working in China smoking 50-pence-packed cigarettes at night. Flew home via Sweden and bought what I thought was chewing tobacco. Found out later it wasn't. It was pasteurized Swedish snus. And then on my return to the UK, couldn't get hold of any more snus because it was illegal to sell. So the British government and the European Union were complicit in keeping me smoking for a number of years because I could only so often get some snus. And I've looked at this, and anyone can try and find a different law, but I think the ban on Swedish snus in the European Union is the law that has killed the most people. I'll happily buy someone a meal if someone can find me a law that competes with it. But it's shocking, really, and there's a real risk that we do the same thing with nicotine pouches. Let's go big picture for a second. Nicotine pouches could be the 21st century invention that saves the most lives this century. That's really possible. You know, in the 20th century we had vaccines, but this century, potentially, nicotine pouches, if they're given the opportunity, could save millions of lives each year. Now, why nicotine pouches compared to vaping on that? Well, the real... point there is that nicotine pouches can be produced at a price competitive rate to cigarettes which when it comes to low and middle income countries are vitally important because vapes are more expensive to produce and so can't be sold to compete with 50 pence a a pack of cigarettes. We know the price point works. In the developed world, vaping has been successful because it's cheaper in most countries than smoking. But that's only because the developed world taxes cigarettes at such a high rate that it's cheaper. But that doesn't really exist in the lower middle income countries. It really frustrates me that when you Google nicotine pouches, you can find nothing but negative stories when there's this amazing story to be told. And I would just encourage any journalist to look at this and realize this is the story that should be being told about this product. And journalists are extremely powerful. They can have an effect on the number of people that use this product and therefore the number of people that die from smoking. I very much believe in hierarchy of preference. So I have a sort of preference list of what I choose when it comes to nicotine consumption. And, you know, right at the top is snus, actually. And second, probably vaping or nicotine pouches. And then fourth, probably smoking, okay? Now, my point with this is that if countries remove the top one from the list and the next one down for that consumer is smoking, they're going to go to smoking. And I see that a lot where you'll have someone that, say, would use heat, not burn products. and their second choice would be smoking, and third would be vaping. But that country potentially has banned heat, not burn. So politicians should leave the decision-making of what product the consumers want to choose to that consumer. I think policymakers and those in public health struggle with that philosophy. They're so used to prescribing the answer. They're so used to telling people what they should do with their lives and not realizing they should leave a smorgasbord of options to the consumer to make their own decision. So choice is vitally important. And on that matter of choice, there's demand. frankly, politicians can't control the demands of the public. They can shape them with regulations. They can shape them with allowing or disallowing advertising. But if there's a demand there for a product, implementing bans, like we're now doing in the UK, with bans on disposable vapes, potentially bans on flavours, taxes, it doesn't end demand. We know that from the world of drugs. All it does is remove legal supply. And like with me, I found my illegal supply of snus on the market. And if they go and ban nicotine pouches, I will therefore be forced to go to the back market, but I will, and nothing will stop me doing that.
26:08 - 26:56
[Martin Cullip]
Let me bring up the subject of education, because you're talking about these products as if you have a perfectly educated population of these products. But I speak to people often, and they confuse pounces with other forms of smoking tobacco, like chewing tobacco or some of the stuff you get in Asian countries. And you'll regularly see... If there's an article about nicotine pouches, something below the line in Daily Mail or somewhere saying, oh, well, they're fine if you want a hole in your throat or something, where they're talking about a completely different product. So how do we get the public to understand what pouches are and what snus is? Because, I mean, snus is only recently talked about in the subject football is using, for example. I mean, how do we get the public to understand what the difference these products are? Because I didn't know myself, really, until I started using them.
26:57 - 29:07
[Mark Oates]
Well, it would be helpful if journalists were reporting more accurately. Not all journalists are inaccurate, but most in the UK press are. I know I work very hard to try and inform journalists of the facts. sector has a very strong role. So in our country, the National Health Service, the effect of Public Health England coming out and saying vaping is 95% safer, at least, in comparison to smoking. And this product's been around in the UK for a good six years, but yet it hasn't been jumped on by smoking cessation services, and it should do. And I think that would be a really big win if alongside vaping products there was also nicotine pouches. The biggest comparison is the COVID vaccine. The public perception of the COVID vaccine, a huge amount of money and effort was put in by governments across the world. But in Britain, we put hundreds of millions into informing the public of the facts. And the government just doesn't seem willing to do the same thing when it comes to smoking and safer nicotine products. Now, they don't actually have to. It can be left to industry, because they're the ones that are going to make the money out of the product, with a framework that they have to work to allow that message to get out to the public. I think in the UK, cigarette packets should have a little card in them that informs the smoker of the options and alternatives so that they know that there's heat not burn out there. Heat not burn suffers from a lack of marketing because of the fact it's got tobacco in. and there's so many smokers that have tried vaping, it's not for them, but if they knew about Heat Not Burn, they could make the switch. They could be informed on pouches, they could be informed on vaping products too. So if government's unwilling to put money in, then at least leave the opportunity for industry to have a clearly defined message, not a commercial message. I don't think that would be right, but a facts-based message. Perhaps a message from our chief medical officer. He was very keen to tell us all that the COVID vaccine was safe. It was a very successful campaign, quite rightly. We should do the same thing with safer nicotine products.
29:08 - 29:15
[Martin Cullip]
Okay, thanks. And lastly, we come to you, Cecilia. Do you want to give us your initial views?
29:15 - 39:33
[Cecilia Kindstrand-Isaksson]
Thank you. The theme of this panel was the real story regarding nicotine pouches, and as many others in the panel have been talking about snus, I think it's impossible to separate the development or the growth of snus in the Swedish and Norwegian market from what we see now with nicotine pouches. Snooze used to be a very clay-like, fairly not attractive product, but there was consumer demand, and according to the urban legend, there was a retirement home outside Gothenburg that went to the company that was the state company at the time and asked them to sort out the administration of snus because they felt that the staff shouldn't be able to bake the snus for the retired older gentlemen. So the company, the State Monopoly, went back and figured out that we'll just stick it in a tea bag. And this was done in the 1970s. That led to, it took some time, but it led to uptake of snus because it became an attractive product. It became more attractive to use. It became easier to use. And since that time, since 1970s, it has really grown in Sweden. As Anna pointed out, we are below 5%. And if you look at different age groups, if you look at the younger age groups, you have virtually no one in going into smoking. And you see the same pattern in Norway, that young people do not start. So it's almost like a vaccination. And this is according to public health data, public statistics. And then, of course, this all took place. Sweden was not a member of the European Union. UST started their factory in Scotland with moist stuff, Skål Bandits. Then the UK, thank you very much for that, decided to ban oral tobacco And that ban later was transferred into the European communities. And that happened before Sweden and Finland and Austria joined in 1995. And this is quite interesting, because we managed to get an exemption. We wouldn't have joined the European Union if we wouldn't have been allowed to keep snus on the market, because it became a... a matter of national pride. The Norwegians negotiated membership at the same time. They never joined, but that became their agreement with the European Union. Finland also initially had the same exemption, but they traded it towards the end of the negotiations for agriculture subsidies. So it was the last trade they did in the negotiations. So we joined with the possibility to to keep snus on the market. And the same was the case for Norway in their agreement with the EU. And that led to remarkable public health impact. I know other people, the other side is usually saying that, well, Swedish men don't smoke because they are very good at understanding public health information. There is one such quote in a commission article during the Court of Justice. The council representative said that the reason Swedish men don't smoke is because our paternity leave. There is so many different explanations from the public health side trying to explain why Swedish men don't smoke. but they will not entertain the idea that snus could have something to do with it, which is interesting if you consider the tobacco consumption pattern in Sweden. I don't want to talk to you about the enormous amount of data we have, public health data, on the impact of using pasteurized, low nitrosamine, smokeless tobacco. It's there. I joined the company Switch Match 15 years ago because we thought that it would be possible to remove the ban on snus. We have the data. Look at the statistics. Look at the data. But then it's not about logic. It's not about... This is about politics. It's not about logic. It's about deep... believes, and there are two sides. One side is whatever the industry is doing is absolutely madness. And our side is that we can actually, we have developed product that can actually help people away from smoking. This was the mission of our company. We divested our cigarette business in 1999, so we got rid of the combustibles. We had a bit of cigars on the side, but our aim was to catch that piece of the market, to get the consumers that are smoking. But we weren't allowed to do that because we were stopped. We could do it in Sweden, but we were stopped from our wider home market, which is the European Union. There are so, as I said, there's a lot of data, but it doesn't matter because the ban remained. It remained in 2001. It remained in 2014. And it still remains. And I've sometimes heard people saying that, well, we don't want snooze because people are not going to use it anyway, so why should we put a new product on the market? But if people wouldn't like it, it wouldn't be a problem. But if even two or five or ten or a thousand people would use it, that are spoken currently, that's a public health gain. So, going to pouches and what we're seeing, and I think this is not only about pouches, it's about the political debate that's coming in Europe, and I'm going to read you a couple of quotes from the almighty administration, the European Commission. quotes or paraphrasing. So there are no safe levels of nicotine, which is a response from the Commission on a parliamentary question. I think that the Commission's risk assessment management people would take offence. I guess you would take offence also if you're Norbergian. because I mean, there are safe levels of nicotine, but this is an illustration of where the debate is going. The popcorn lung, the sort of suggestion in a debate that well, we have all seen the, media on vaping and popcorn lungs. That's something we don't want to have. I mean, what is this? This is like the guardian representatives of the institution gardening the treaties, and with all principles in there, stating stuff which is far from true. Popcorn lungs and vapes. Vaping kills, another excellent statement from the commissioner for taxation. Vaping kills in relation to what? It's those kind of overall arching statements which doesn't put things in context. Politics and decision making is all about compromising. It's all about finding a good solution. You have to compromise. I think it's extraordinary how you see the narrative going from the commission, and it's underpinned by the type of tobacco control organizations. And I think it's a stupefying debate. Another one is that I read in a paper. Attraction of reduced risk products stems from the fact that they are perceived as less harmful. Perceived. I think we can, from a tox point of view, from a risk assessment point of view, I don't think it's a perception. I think it's a fact. Apparently, we are targeting children. Anyone who believes that we are targeting children, I can invite you to a compliance training with PMI. This is also an interesting one, which is, no study has shown that less harmful products are better for cessation than current available methods. I think we have an interesting case study in Sweden with what less harmful products results in. And yeah, it's a gateway. to smoking for young people, the gateway. The gateway has been around. I have not seen any interesting evidence that gateway from reduced risk to combustion exists, but maybe there is. What we have seen is that there is a gateway out of smoking. All in all, we should remember that It could have been much worse. Had the Commission gotten what they wanted in 2012 when they released the draft directive, and the Member States and Parliament had voted in favour, vaping would have been not a consumer product. Vaping wouldn't have been available. I think if you look at the narrative, they will go after, they want to equalize, is our sense. They want to equalize reduced risk products because they're equally bad. And that's what's coming. I will stop there.
39:35 - 40:02
[Martin Cullip]
Okay, well, considering you ended there talking about the EU, I have got a question about the EU. I mean, I've seen the plans that the EU's got. Will there be a credible opposition from MEPs at the EU level? And I was involved in protesting against some of the wild things they were going to do at the 2012 TPD2, wasn't it? Is there going to be some opposition at EU level, do you think, to these plans that the EU has?
40:06 - 43:11
[Cecilia Kindstrand-Isaksson]
I think there are people in the European Parliament who see the potential with the pragmatic regulation around reduced risk products. It's not like it should be free for all and we should have whatever, 50 milligrams nicotine. And this comes back to the importance of a proper risk assessment and a proper assessment of the products. Because you want to balance, from a regulatory perspective, you want to balance the availability two of the products for the smokers that wants to to continue using nicotine so they can switch but there's also public health elements so you need regulation to product protect kids groups that shouldn't use nicotine etc etc so there are people being pragmatic what i'm afraid of is that you will have this sort of increasing moral panic on kids and adolescent brain. And it's so easy that that sticks. In Denmark, there was a moral panic because apparently Danish dogs consumes nicotine pouches, which is not the case with Swedish dogs. And if you're a policymaker, you want to have a rational approach. So I do believe that there are people in the European Parliament. And we will see. But you remember from last TPD as well, it was pragmatism versus... Because on the member states' side, it's quite clear that we have some member states that have already regulated it, because they... They want to protect public health, but they also feel that these products should be available. Sweden is such an example. But there are a couple of other member states that have pragmatic regulation. And then you have the countries going for a ban. The Spanish ban. The French draft ban is interesting. Apparently, it will be banned to possess and use nicotine pouches. And good luck enforcing that when you have thousands and thousands of Swedes going to the Alps every year for skiing. Luxembourg has put this, they are regulating, they're proposing to regulate the product as a tobacco product, which is good, I mean, because then you get the advertising and you get some measures. And then they're putting this limit of 0.048 milligrams for a pouch, and that's like nothing. And that's based on a risk assessment from 2009 that the European Food Agency did, to establish how much nicotine you should be allowed as a pesticide residue in mushrooms. But we're not talking about the fact that people smoke like there's no tomorrow in Luxembourg. That kind of nicotine we don't talk about, but they choose to go for this one. And as Anna said, if you look at the toxic profile, it's just ridiculous. Why don't they ban cigarettes?
43:13 - 43:40
[Martin Cullip]
Okay, thanks. I want to ask a question because it's something that was mentioned. Policymakers and politicians will all talk about these products, vaping, heated tobacco, poultry snus, and they'll talk about the fact they're addictive. So I think you, Mark, do you want to explain that? How do you counter those messages from government that, yeah, okay, these are less harmful, but they're addictive?
43:40 - 46:19
[Mark Oates]
Well, the purest way of doing it, and how many people I know here have spoken about it, is that dependence and addiction are two different things. And dependence is continuous use, a requirement to use it, but it doesn't come with harm, which is what we're really looking at with these products. And addiction is the dependence with the harm. Now, when I say that, I think, is that too complicated for politicians to understand? Perhaps, but we've got to try. And when I speak to politicians and I speak to the public, getting that point around what the aim is here is to reduce the harm caused, not a dependence on a product. The dependence issue is really you're going to use a product for a long period of your life. A product that I personally feel brings me a lot My wife loves her coffee, and I know you've spoken about this, Martin. She probably has a dependence on caffeine. But I don't do a huge amount of caffeine. I spend my time consuming nicotine, and I find my concentrations better. There are benefits to it, working. I mean, we know that nicotine can give a... performance enhancing improvement when it comes to cardiovascular performance. So on the World Anti-Doping Agency list, nicotine's there because it can give about 10.4% increase in cardiovascular performance. We know that athletes are consuming it. That's not a problem. They're consuming caffeine and other products to improve performance. So I think trying to get the message home to politicians that it's the harm that matters, not continuous use of a product. Because where do we go? If they focus on continuous use and dependence, then the next step is dependence on caffeine. That would be Starbucks ban. That would be plain packaging on that. Alcohol is a slightly different subject. Because dependence and addiction for that drug is in itself harming. And it's harming for the body as well as it is for being in a continuous state of drunkenness. Each drug in itself is different, and nicotine is not something that you consume which is going to make you dangerous in any way. In fact, it's quite the opposite. You're going to see improved performance. So a lot of this comes, let's not forget, a lot of this comes from the newspapers who are driven by a certain billionaire, and it seems to get the attention of readers having that word addiction in.
46:20 - 47:09
[Martin Cullip]
Yeah, I admit, as a vaper, it does irritate me when they'll conflate the two. They'll say, you know, people say that vapes are much less harmful than smoking, but they're still addictive. And addiction and harm are two separate things. Yeah, but don't talk to me about coffee. I went to the Philippines a couple of years ago, and every breakfast, someone was trying to give me coffee. And I don't drink teal coffee. And on about the third day, the guy crept up behind me to put the coffee on the table because he felt I should be drinking coffee. It's fine for him to force that on me, but if I had one of the vape, he probably would have reacted like I'd set off a hand grenade or something. So we're talking about harm. So can I ask you, we know about the continuum of risk of different nicotine products. So we say they're less harmful, perhaps they're less harmful. How much less harmful would you say?
47:10 - 48:21
[Anna Franzen]
Do you want a number? Just try and explain as best you can. So as Mark also pointed out, if you take away the chemicals that are causing the COPD, that are causing the cardiovascular effect, that are causing the cancer, then you won't have any harm in that sense, left. And that's what we have in nicotine pouches. So what is left is nicotine. And if we compare to nicotine replacement therapy that I was talking about before, there has been long-term studies done, of course, because it's been around for so long time. And none of these studies could show any statistically significant effects on cardiovascular. So... So on this continuum of risk, I would say that nicotine pouches and NRT are exactly the same.
48:25 - 48:45
[Cecilia Kindstrand-Isaksson]
Actually, there is a paper that I recommend, Back at All, where we compare... smokeless tobacco, our nicotine pouches and NRT, and it's actually that our nicotine pouches slightly less, contain slightly fewer toxicants than gum, nicotine gum.
48:46 - 49:08
[Martin Cullip]
Right, okay. I want to ask you, Barnaby, because we're talking about these products, we talked about addiction, we talked about they're less harmful. What about popularity? As we spoke about USA, there's a massive growth. Is that going to be a problem in the future, or is that something we should be pleased with? Well, I suppose we should be pleased with, but is it going to be a problem in the long run?
49:08 - 52:59
[Barnaby Page]
Well, yeah, I think that's quite right. It's a double-edged sword in many ways. It's something we should be pleased by. There's some you know, this take up of a new or newly significant form of tobacco harm reduction. At the same time, it poses a problem because it clearly will bring nicotine pouches much more to the attention of people who are opposed to THR for one reason or another. Now, I mean, and this kind of ties in very much with the points that have been made about addiction and dependency. So, you know, if we look at it logically, dependency is only a problem if you have large numbers of nicotine naive users coming in, and if you then have a gateway to combustibles. And as far as we can see, we have neither. I mean, for example, we did a survey of pouch users in the United States. We found about half were coming to pouch straight from smoking. Only 5%, one in 20, were nicotine naive. The rest were coming from various combinations of smoking, vaping, other oral products, and so on. However, that is not necessarily the perception. I think the perception of power very much is driven by its online presence, particularly its presence among influencers, the so-called influencers are very big here. And of course, there is also the issue of big tobacco involvement, again, It's a sector that is relatively dominated by the big tobacco companies. So those are, if you like, issues that we may have to confront with Pouch. We're also seeing some signs of... of concern about pouch usage among minors. There was a University of Southern California study recently suggesting that high school usage had doubled over the year 23 to 24. Now, this was only doubling to about 4%, far less than vape. And, of course, most people in this room will know that's against the background of a massive reduction in high school smoking over recent years. So, you know, we might say nothing to be concerned about. But these kind of numbers are very much the numbers that will be, you know, that can and will be used against pouch. I think set against that on the positive side, in the US, for example, you know, there is the precedent set by FDA approval and then potentially, you know, the FDA modified risk authorization coming up. In Europe, you know, there's certainly, although there are certainly countries where there's a strong anti-pouch sentiment. There are others where there is a, you know, there is much stronger pro, and of course we have the, you know, if you like the classic success story right on our doorstep in the form of Sweden, as alluded to. I think if I can just go back to the question of addiction for one second as well. I think, I mean, just one other point to make there is, you know, quite appropriate to mention this at a harm reduction conference, because I know a lot of people at this conference over the years have come from the drug harm reduction background. there is an antipathy toward addiction in general. I mean, when I was growing up in the 1970s, and I'm sure many people in this room will recognize this, to say, oh, you know, if you do that, if you don't brush your teeth or whatever, my son, you'll grow up to be a drug addict. You know, that was pretty much the worst fate imaginable. You know, much better you should be a serial killer or something like that. And so, you know, those sort of perceptions of addiction in itself being an absolute terrible disaster that we must at all costs protect society from, you know, is still, I think, very dominant in a lot of public health thinking. Now, there is some validity to that, to be sure, but it can certainly overshadow any perception of the benefits, and I think that's, you know, one of the issues we have coming up here with the issues about addiction and dependency that you talked about.
53:01 - 53:44
[Martin Cullip]
Okay, that's great. Yeah, that's a great answer. Thanks very much. I want to talk finally about, we'll come to the audience soon, and that includes people, because this is being live streamed, so I think there's a facility you can put your questions at home as well. But I want to talk about regulatory things to do with the World Health Organization. I mean, they've recently come out and said that all flavors of every nicotine product should be banned. They're They say that pouches should be banned worldwide. Will we ever be able to persuade the WHO to come out with more sympathetic policies, do you think? What threats are we going to see maybe in November at the next WHO COP meeting?
53:45 - 55:03
[Cecilia Kindstrand-Isaksson]
Do you want to start on that one? I don't know, to be honest. And I'm not following WHO that closely. I believe that if we can demonstrate, if people are actually switching from combustibles to reduced risk products, whether it's pouches or snus or whatever, then those products have a role to play in public health. We have good examples from Sweden and Norway with snus. I think UK is a good example when it comes to vapes. Had the UK government at that point been successful in persuading the medicine, in other words, to take over vapes, we wouldn't have had the 3 million plus egg smokers that we have today. So for me, this is a bit of power to the people. I think if I look at the European Commission, the WHO, Europe, and sort of their... Thinking at the moment, I think it's going to be tough. But if smokers are going for less harmful products because they want to take control, then we will be successful as an industry. If they don't, we will not.
55:04 - 55:19
[Martin Cullip]
There's a question here from people at home on that subject. Why does the harm reduction clause in WHO FCTC get ignored, especially when the WHO and UN recognise harm reduction in other drug use? Does someone want to take that one?
55:22 - 55:56
[Cecilia Kindstrand-Isaksson]
I think it's the fact that harm reduction is a rational policy, but I think the issue here is the industry. Being an industry representative myself, I think it's fascinating that people tend to not want to engage on substance. They are like, oh, we don't want to talk to industry because they are like the most evil thing you can think of. But no one ever addresses the substance. And I think that's the problem.
55:56 - 56:25
[Martin Cullip]
I should explain, people will probably know this, but Article 1D of the preamble to the FCTC Treaty does talk about harm reduction being one of the methods that you can use to help reduce people smoking tobacco. And it seems to be routinely ignored, unfortunately. I think we've got 15 minutes left. Have we got any questions from the audience? Yes, one from Richard down there.
56:28 - 56:43
[Attendee]
Yes, so in the UK we are seeing some, I think, positive moves in terms of legislation around nicotine pouches, particularly the 18-plus age gate that will hopefully shortly be introduced. Is there any other positive news from around the world to contrast some of the doom and gloom we've unfortunately had?
56:45 - 56:53
[Martin Cullip]
You're probably the best person to answer this, Barnaby. By the way, that's Richard Crosby from Considerate Pouches. I should have said, when people stand up and ask questions, they say who they are.
56:56 - 58:50
[Barnaby Page]
Yeah, I don't think there's a great avalanche of positive news in the sense of lots of countries rushing to reverse bans on nicotine pouches, let's put it that way. There are still a lot of opportunities of positive news, I think. France, for example, would be a very good example where, as I think I mentioned earlier, there's an official proposal to ban pouches, there are three counter proposals to regulate them in various ways. I think within the within the EU and the next incarnation of the Tobacco Products Directive and the Tobacco Excess Directive and so on, there is still quite a lot to play for. I think there's been an assumption that the position will be very, very negative on pouch. However, as we saw in the past with vape in the TPD, there is a certain pattern that the Commission proposes very stringent regulation, the Parliament then moderates that. Elsewhere in the world, I mean, you know, we have countries where bans are quite entrenched. You know, Brazil would be an example. I don't necessarily see anything like that being reversed very soon. But the position in the United States is the other good news. Yes, it is a country where pouch is certainly vulnerable to public health criticism. It's a country where I think we could see municipal or state-level action against pouches, as we did with vape. But on a federal level, pouches, if anything, so far probably more accepted than vape. And, you know, insofar as you can argue the Trump administration has any position at all on specific nicotine products, it's probably quite pro-pouch. So, yeah, there are glimmers of good or at least not bad news, but I wouldn't say there's anything to... throw a party about just yet.
58:50 - 58:54
[Martin Cullip]
Okay, thanks. There's a gentleman over there, if you could have a microphone.
58:56 - 60:24
[George Cassels-Smith]
George Castlesmith, Tobacco Technology, United States of America. Barnaby, in the beginning, and first of all, I love e-cigarette intelligence. It's great data. You were starting in your preamble, and you said the rise of the naïve in the market of nicotine pouches in the United States. And I think words matter. And right now we see approximately 65% of the global consumption of nicotine pouches occurring in the United States. And we see a precipitous drop in the conversion of cigarette smokers to these safer nicotine products. How naive is the US consumer and how is this rise occurring Because I would say that we've already lumped globally the consumption of guca and palm macella, which is a very deadly cocktail, into the oral category to make it seem as if it's more dangerous than it really is in the moist snuff and the snooze categories. But these consumers are changing because the government tells them that this is just as deadly and as deadly a form of nicotine as any other. But they're not naive. They know this. They know that's not true. And that's where they're growing. They might be younger, but how naive are they?
60:27 - 61:59
[Barnaby Page]
Thanks. Well, yeah. Just to put some numbers on it, I mean, when we did our U.S. survey, for example, recently, we found that In fact, only to address one form of naivety, which is nicotine naivety, people have not used nicotine before. We found that only 5% of pouch users, as I said, were nicotine naive. All others had used nicotine in other forms. What's kind of interesting, though, in that context as well, I think, is the reasons that people adopted pouch use. And health was generally not a big reason there. It was around 20% of users had been driven to Pouch primarily for health reasons. Now, that doesn't mean the other 80% were unaware of the health factors. They may well have been there in their mind. But social influence and curiosity, social influence no doubt tying in with social media as well, were really the dominant reasons that people moved to Pouch. So, yeah, I think it's probably safe to say that the movement toward pout is perhaps a little more trend-led, a little more media-led than a health-led move toward vape would be. However, that's not to say that this is dominant by any means. And in a sense, if the risk profile is sufficiently low, as long as you're not bringing in large numbers of nicotine-naive users, you might say, well, who cares why they start The good thing is that they do start.
62:00 - 62:55
[Martin Cullip]
Okay, thank you. We can have one from Jeannie here, but I'll answer one of the questions on the Q&A from home from Kurt Yeo, who is a consumer advocate from South Africa. He says, if the WHO FCTC is politically driven, why have we not seen the likes of Sweden, UK and New Zealand insist on more robust conversations on tobacco harm reduction? And I can actually answer this one, because Clive Bates mentioned this recently in something he spoke about, where he said that these treaties tend to be countries go along and they have a red line. And as long as someone doesn't cross that red line and start infringing on their own policies, they're not going to say anything. They're not going to stand up and say, we love harm reduction. So I think that's why these things don't happen. Those international treaties, the UK especially, will just sit there and defend its own policies. And so it's not going to actually come out and push itself out and make a fuss. So I think that's the answer to that question. Jeannie, have you got a microphone? Yeah.
63:00 - 63:45
[Jeannie Cameron]
Thank you. I think my question was very similar to that last question. I was going to say, given that Sweden is the only country the WHO deems to be smoke-free, and the position of the Swedish government, what more can be done for the Swedish government to actually stand up and talk about its position maybe at COP11? Or, you know, what's... holding the Swedish government back from doing that. I know for many years it has not said anything. And given the derogation that it has in the EU and why it fought for that at that time, is it not willing to share its experience more broadly and bring other countries along at something like the COP?
63:47 - 65:24
[Cecilia Kindstrand-Isaksson]
Thank you. It's of course political, as always, and every country in the European Union wants to be... I mean, we're a team playing, and we respect international law, and I think what we've seen so far, having worked on the last TPD, The Swedish government looked at this ban on snus from a trade perspective because there were discussions within the government and my sense was that the public health, they didn't want to push the public health agenda. And I think that's also because the country is committed to the WHO generally. They're committed to the framework agreement for good reasons because smoking is a massive problem. But I think what has shifted with the Swedish detailed opinions to Spain and to France is that besides the trade augmentation, they're actually engaging substantially on health, where they're actually making the point that the fact that there has been an alternative product on the Swedish market has resulted in public health gains and that's something new i guess this might be addressed when the eu negotiates its mandate for the next cop but then there's also as i'm sure you're aware that the the health the health part of the government has one view whereas and then you might have a conflicting view from other parts of the government so that's also in play there
65:28 - 65:29
[Martin Cullip]
John in the third row.
65:36 - 66:02
[Jon Fell]
Hi, it's Jon Fell from London. Question for the panel. In this phase where pouches, or regulation of pouches, is still undeveloped, it's a bit of a wild west, do you think industry, and I mean that in a broad sense, big, small retailers as well, is industry doing enough to shape pouches being perceived positively by the wider public and shape regulation? Is there a role for self-regulation?
66:04 - 66:05
[Martin Cullip]
Do you want to tackle that one?
66:06 - 67:54
[Mark Oates]
I mean, there's very little opportunities, I think, for industry because of the lack of the ability to get engaged with politics. But the modified risk point over in America, I mean, what can go on there is fantastic. And obviously, Zinn is going for that. And they've done it with Heat Not Burn as well. So that should be the target, I think, trying to get the FDA, modified risk. We don't have, as far as I'm aware, a system like that in Europe or the UK. But yeah, strangely, you know, America has been such a success culturally. You know, Zin has become part of the lexicon and it's taken a political position. And so there's an irony in that you could spend all your time thinking very strategically and thinking very scientifically and about public health. But sometimes something just sets off in a country and it becomes a subculture. And I've really noticed that in the UK. Nicotine pouch is a bit of a subculture. I used to go to the pub. pull out my nicotine pouches about five, six, seven years ago or snooze. And my friends would be saying, why have you brought your hair gel to the pub? But now everyone knows what they are. And the military is a really fascinating small subculture. And America is massive. And I know of British Army units that have gone out to train in America. And there's a high smoking rate in the military. People don't really think about their existence in 35, 40 years' time. And those smokers have come back using nicotine pouches. And it's really taken off in the British military because of those links. So you could say NATO's done more for harm reduction than the World Health Organization. Yeah.
67:57 - 68:00
[Martin Cullip]
I knew you'd get NATO in there somewhere. I really do.
68:00 - 68:20
[Anna Franzen]
No, I just wanted to add that I think that what we are seeing now with new startups, new small companies, new innovations, that that is important to drive this even further and making this category more credible. And I think that's important.
68:21 - 69:37
[Cecilia Kindstrand-Isaksson]
Can I just on what the industry has done something in there is a technical specification in Sweden and there is a standard in the UK and those were developed in anticipation of regulation and it looks like it looks at maximum nicotine like quality stuff that you need to think through during manufacturing limits or bans on unwanted substances There is also a discussion within ISO, because all the industry colleagues I'm speaking to, we all recognize that the lawmakers are running behind. But if you look at European countries, there are quite a number which have pragmatic regulations. So you have the Scandinavian countries, you have Finland, Romania, Greece, Czech Republic, Slovakia. So I think you have a hand for quite a lot of countries. And then there are still a number of countries which regulate it or they view it as a consumer product. And that is a problem because then you don't get the age gating. Then you don't get the marketing restriction, et cetera, et cetera. So we can do more, but we have done something at least.
69:39 - 69:49
[Martin Cullip]
I'll just quickly ask the last question. Skip Murray there from America. She's asking, are there any studies following individuals who use NRTs for an extended period?
69:52 - 70:21
[Anna Franzen]
Yes. So there are a lot of studies on NRT. they haven't shown any connection specifically to, I mean, because the cardiovascular effects has been the talk about nicotine, but those long-term studies hasn't shown anything, any effects on the cardiovascular system. So that I think is very important to state.
70:24 - 70:36
[Martin Cullip]
Okay, we're just coming to the end, so I'm just going to ask one last question of the panel. I wouldn't like you all to answer in about a minute or less, if you could. So I'll ask everyone, are nicotine pouches here to stay?
70:39 - 70:39
[Cecilia Kindstrand-Isaksson]
Yes.
70:43 - 70:58
[Martin Cullip]
A real mic drop moment, that one. Absolutely, yeah. I don't know. Yeah, with all these attacks on regulatory bans that we're seeing, are these things here to stay long-term?
70:58 - 71:16
[Anna Franzen]
Yes, yes, of course. I mean, I don't think that we... I mean, if you're looking at the harm reduction, the risk management, the toxicology, the science, we don't have a choice. I mean, why should we ban nicotine pouches and not cigarettes? I don't know.
71:16 - 71:19
[Martin Cullip]
That's the question, isn't it? Barnaby?
71:20 - 71:47
[Barnaby Page]
At the risk of being predictable, I'd also say yes. And I point for comparison to the vape market. Terrific regulatory headwinds against vape. Terrific level of negative opinion that hasn't actually stopped the market itself and the use of vape from just going up and up and up. Unless some completely unexpected development comes out of left field, I see no reason that shouldn't happen with pouch as well.
71:52 - 72:31
[Mark Oates]
Nicotine pouches are going to save a lot of lives globally. The question is, how many? And that really is the gift of politicians on how they regulate it. And I'm hopeful. And this comes a little bit back to the World Health Organization, FCTC question. Politicians love legacy. If you do any work with a politician, they're thinking about legacy. And it just takes a politician to realize their legacy could be saving millions of lives globally. And maybe attend the COP process. They do it with the environment. If one politician really realized how much impact they can have globally on this subject, it could do an enormous good.
72:32 - 72:59
[Martin Cullip]
I think you said before, haven't you, that someone from the UK should invite COP to London and get the Minister of Health to talk about harm reduction, which would be a wonderful thing, wouldn't it, talking during Jeannie's panel about how it would take one country to do that. But that's something I suppose we can only dream of. But we're just coming to the end here. We've got seconds left. So could everyone just please thank my team, the panel, Cecilia, Anna, Barnaby and Mark for some great responses. And thanks very much for coming. Thank you.