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More than a billion adults globally smoke combustible cigarettes. The harm caused can be reduced if individuals switch completely to smoke-free products. Availability of a wide range of options can accelerate their switching journey. However, access to products is being restricted by either outright bans or flavour restrictions. Whilst aimed at preventing underage use, this overlooks the needs of adults who smoke. This session will focus on a rigorous, evidence-based evaluation of whether product/flavour bans achieve the objective of reducing youth use of smoke-free products, without undermining adult smokers’ access to effective switching options.


Transcription:

00:03 - 08:10


[Mohamadi Sarkar]


Good morning, everybody. Good morning. Morning, morning. Hope everybody's doing well. So thank you very much for joining us. I'm hoping that we can have a good conversation. Look, this is a panel discussion, but I'm also expecting that there's going to be some audience participation so we can, together, try to figure out how best to tackle this problem. So my name is Mohamadi, Mohamadi Sarkar. I'm the moderator. By the way, I'm not going to introduce all the speakers with their lengthy bios, because we're very fortunate to have such an elite group of participants. So look in your booklet, and their bios are in there. So my panelists are Evan, Evan ,, my colleague from Altria. and Marina Murphy from Hyup, and Ryan, and then of course, Jag, his name didn't appear in the slide. For some reason, I don't know what happened. I apologize, but his name in there. But he's a critical anchor to this panel because he brings to us real world, real life experience as a consumer, and he'll share some of his perspective on it. So let me just find the clicker, there it is. So I'm not going to give a presentation. I just wanted to do some level setting. But before I get started, make sure everybody knows that this is the panel on smoke-free product and flavor bands and do they work. So just for ground setting, we all probably are aware of the statistics, right, that smoking has been declining. Cigarette smoking has been declining all over the world. People have heard the statistics as well that there are close to a billion people across the globe that smoke and close to 8 million people die of premature death because of smoking. But the important thing to remember is that behind these charts are people, are individuals that are impacted in the day-to-day lives and What we hope we can deconstruct is the impact that some of the regulatory policies that are taking place across the world, and we have some examples of the US as well, that really makes a difference in the lives of these individuals. And one of the reasons that's often brought up is, well, what about the kids? And that has been the primary driver for many of the restrictive policies that have been implemented across the globe. And I don't have the statistics for the rest of the world, but I'll just show you an example of what's happening in the US. In the US, actually, if you look at the prevalence of tobacco product use in the US, it continues to decline. And at the top here is e-cigarettes and smoking. You all probably in this audience have heard and known that in the US, we have reached a historical low for smoking prevalence compared to what it was many years ago. And it's in the low. 1.5%. And then if you look at nicotine pouches, they hover around 1.7, 1.8. So tobacco product use, particularly the deadliest product, which is cigarettes, is at its lowest. And even if you look at e-vapor use, there has been close to a 70% decline since its peak in 2019. So overall, tobacco product use amongst kids continues to decline. So the question then is that why is it that there's been such an intense focus on taking away the products that actually make a meaningful impact on adults who are looking for alternatives? So if you just look behind the scenes, peel the layers, for e-vapor use, the vast majority of the e-vapor use in the U.S. amongst kids is actually of these illicit disposables. And just this statistics highlights the fact that amongst those middle and high school students in the U.S. who are using e-cigarettes, 66% are using disposable, and of those, about 60% are using the illicit disposables like Geek Bar and Breeze. So actually, a better way to tackle this problem would be to get rid of the illicit disposables. And these numbers would even be lower if there would not be such a rampant market of illicit disposable products. And the problem is that these illicit disposables come in a variety of flavors that are off the wall. typically targeted for bringing young kids into the fold, like bubble gum, cotton candy. I even saw a flavor which was called unicorn blood. And that just is tantalizing for these kids because these are the kids who are interested in risky behaviors. But nonetheless, I think if there's a way to address this problem, the better way would be to curtail these illicit disposables, not completely take away the choices that adults are seeking and are interested in using to make their lives better. So we will now just pivot to the discussion. I'm going to invite Evan to first share with us some of the findings that he has observed based on the analysis of different states, different regions in the US. And then Marina is going to share with us the findings for nicotine pouches because, you know, It's important to recognize that when we think about smoke-free products, it's not just evapor. There are other products as well. There isn't as much on HDP, but nicotine pouches have become quite popular recently. So there will be some discussion on that. And JAG is going to bring in kind of a real consumer perspective. He represents the country from India. where there's an outright ban on all smoke-free products. So cigarettes are still available, Lower risk alternatives are completely banned. So he's going to share his perspective. And then Ryan is going to kind of tie it all in together and share some of his analysis based on modeling as to what is the overall population impact. So that's kind of the roadmap for the panel discussion. And of course, I want to make sure that we leave enough time for audience participation and have a discussion on this issue. And let's figure out some solutions, as I said, And in my opinion, the best solution would be, rather than banning, to clean up the illicit marketplace. So Evan, why don't you get started? Here's a clicker. To this? OK, perfect.



08:13 - 24:59


[Evan Winiger]


Okay, so my name is Evan. I'm a regulatory scientist in the Population Science Department of Altaria Client Services, and we're going to talk about evaluating the impact of flavored tobacco bans in the United States. So let's start by setting the stage. This is the percent of state population covered by a flavored tobacco sales restriction. So you can see that some places have 100% coverage, which means there's a statewide ban. But others have smaller percentages, and that gets at different levels of cities or counties or areas that have them that aren't on a state level. But this all amounts to 27% of the population living in a flavored product ban area. As of right now, two states, Massachusetts and California, along with DC, which is the capital of the country, comprehensive flavor bans. And that means that the sale of flavored tobacco is illegal. That includes menthol cigarettes and flavored smoke-free products like vapor and nicotine pouches. Now, these policies are put in place to reduce harm and to improve public health. But a lot of research coming out calls into question if that's actually taking place. We have studies that show that they don't reduce smoking rates. And we have a lot of studies coming out that show the substitution effect, which has been talked about this week a lot. It's the idea that when you ban or take away flavored smoke-free products, people go back to smoking combustible cigarettes. But there's also research that shows illicit markets thrive. And so all of this together really beckons the question of, do these bans actually improve public policy and reduce harm? Because that should be the main goal of any tobacco policy. So we're going to walk through a roadmap for how I evaluate the impact of flavored tobacco bans. And it's got three pillars. The first is behavioral data. And we're going to use national and state level data to compare smoking rates and smoking metrics in areas with flavor bans to areas without flavor bans. And we're also going to look at menthol use. The second pillar is going to be the market response. And we're going to use discarded pack studies to look at illicit flavored and non-local products found in areas with flavor bans after flavor bans. And then the third pillar is the economic impacts. So using tax revenue, sales revenue to determine cross-border purchasing that circumvents bans. And these are the localities we're going to look at that have flavor bans. All three of these have comprehensive flavor bans. So it's illegal to sell menthol cigarettes and flavored smoke-free products. But we're going to look at California, a large state on the West Coast, Massachusetts, a smaller state on the East Coast, and then the District of Columbia, an even smaller area. And the first pillar is smoking behaviors in response to flavor bans. And again, we're gonna use representative national and state-level data to compare smoking rates in areas with flavor bans to areas without flavor bans. And we're gonna use several government-sponsored data sets to do this. The first one is BRFSS, or the Behavioral Risk Factor Survey Surveillance System. It's an 18-plus data set, and we're gonna look at that in Massachusetts, California, and the District of Columbia. And the second data set is the NSDUH, or the National Survey on Drug Use and Health. This is a broader data set that includes underage and measures of cessation, and we're gonna look at that in Massachusetts. But ultimately what we find in our behavioral data is that there's no meaningful reductions in cigarette smoking, nor are there increases in cessation for adults and underage individuals when we look at areas with flavor bans and areas without flavor bans. And we also see that menthol use remains prevalent. So we're going to start with Massachusetts. And I'm going to introduce the main analysis for this behavioral data. It's called a difference in difference analysis. And what it does is it allows you to compare the smoking rates of an area with a flavor ban, so Massachusetts, and compare those two areas without flavor bans, our comparison states or our control group. And what you can do is see if an inflection point, so the flavor ban here in June of 2020, you can see if that was associated with a change in smoking rates in the area with the flavor ban compared to the area without the flavor ban. And so we're going to look at that in BRFSS and Massachusetts for the 21 plus data. And our difference in difference is non-significant. And what that means is that the Massachusetts flavor ban did not reduce adult smoking compared to the areas without flavor bans. And this figure on the left does a really good job of illustrating that. So you can see Massachusetts smoking year over year, the comparison states without flavor bans year over year. And you can see when that flavor ban hit. Now, you can see how the Massachusetts smoking rates more or less parallel those comparison states without flavor bans. We know that about a third of adult smokers use menthol cigarettes. And so had that ban worked as intended, had taking away menthol cigarettes led to some kind of substantial decrease in smoking rates, we would have expected the smoking rate to go down closer to 7% several years after the ban. But again, we see smoking rates that in Massachusetts that parallel those comparison states that don't have flavor bans. On the right is BRFSS data for 18 plus individuals. It's a little bit more restricted, so we couldn't do a difference in difference, but this allows us to chart the menthol use. And you can see that 3.9% of 18 plus individuals were using menthol before the ban, and in 2023, several years after the ban, that's 3.6. There is not a change there. So people are still using these products, and that still amounts to about 22% of adult smokers using menthol cigarettes several years after the ban. So we're gonna stick to Massachusetts and look in that NSDUH data set. And we see that the effect of the flavor ban is negligible again. On the left is smoking cessation rates. This is a measure of established smokers who haven't smoked in the past 30 days. So that's why it's kind of high on this figure. But you can see that in Massachusetts, cessation rates don't drastically jump up following this ban. Instead, they more or less parallel those comparison states that don't have flavor bans. And on the right is a figure that shows the estimated smoking prevalence for adults 21 plus in Massachusetts and those areas without flavor bans, both before and after the ban. And we can see that the smoking rates hardly change from pre to post, and our difference in difference finds a clinically negligible effect. So the real takeaway here is that there's no substantial reduction in adult smoking following the flavor ban here. And we're going to be able to look at underage individuals in Massachusetts with this data set. And again, we see that the effect of the flavor ban is negligible. You can see on the left here that smoking cessation rates actually go down while under the comparison states that don't have flavor bans. And when you look at the estimated smoking prevalence pre and post ban, you can see that Massachusetts smoking rates for underage individuals actually goes up post ban. But the difference in difference, our main analysis here, finds a clinically negligible effect. And so ultimately, the takeaway is that underage smoking did not decline following that flavor ban. So we're going to switch states and go back to that BRFSS data set. And this is for California. Again, our difference in difference finds there is no effect of this ban on smoking rates in California. So it didn't reduce adult smoking rates compared to the areas with flavor bans. And you can see California here, the smoking rates year over year, along with those comparison states that don't have flavor bans, you can see that after the flavor ban, they more or less parallel that trend of those comparison states. We know that about a third of adults were using menthol cigarettes before the flavor ban. And so again, if that ban had worked as more intended, had banning those products actually had an impact on smoking prevalence, we would have expected it to go down to something like 5% several years after the ban. But we also did a difference in difference here for several smaller groups, including young adults and Hispanics. And we find that the flavor ban might have actually slowed smoking decline amongst these vulnerable groups. Our difference in difference was significant. And there's smaller declines in cigarette smoking amongst Hispanics by 19%. and adults aged 21 through 34 by 26%. And so what that means is that the flavor ban is slowing the smoking of decline. And one of the things that could be taking place is that substitution effect, that when you take away flavored smoke-free options, people actually go back to combustible cigarettes or switch to combustible cigarettes. So overall, this flavor ban in California didn't reduce adult smoking and might have actually hurt certain groups. And then our last behavioral data point is in DC. And again, we see that adult smoking rates did not change after the flavor ban in comparison to areas without flavor bans. Our difference in difference is non-significant. And you can see on the figure on the left, A lot of people use menthol in DC, about 2 thirds. And so had taking away those products had a substantial impact on smoking behavior, we would have expected it to go down much lower. But again, we see smoking rates year over year that more or less parallel those comparison states that don't have flavor bans. And so now we're going to switch to our second pillar. And this is banned tobacco products found in localities with flavor bans. And what we did was we conducted discarded pack studies where we actually send individuals out to different representative areas of a state or a locality to actually dig through trash and to look for the types of tobacco products being used. And for cigarettes, they're looking for if they're menthol or non-menthol as well as the tax stamp to see where the packs actually came from. And then with vapor, they're looking to see if they're flavored or not. And what we see is that localities with flavor bans have large amounts of flavored products. That includes menthol cigarettes and flavored e-cigarettes. But we also see large amounts of tobacco products come from outside of areas with flavor bans. That suggests cross-border activity that circumvents the ban. We'll be looking at two areas for this, California and the District of Columbia. This was our discarded pack study for DC. This took place about a year and a half after that flavor ban. On the left is DC menthol share of cigarettes. You can see that about two thirds of all packs found were menthol, so an illicit product. And before the ban, in sales channels, about two thirds of cigarettes sold were menthol. So this kind of speaks to the demand is still there after the ban, and people are still finding those products. When we look at the cigarette origin assessment, so the tax stamp on the cigarette to see where it came from, we can see that 62.3% were domestic or non-DC tax stamp, meaning they came from states within the country. And of those, 72% were menthol. So that gets at cross-border activity. And of those that were not in DC, most of them were from Virginia and Maryland. And then when we look at the flavor devapor prevalence, 99.6 were flavored. So almost all products were illicit in this area. And we're now gonna look at a similar study in California. On the left is menthol cigarette prevalence. You can see 7% were menthol workaround. These were certain products introduced by certain tobacco companies that were menthol kind of analogs or similar to menthol that have since been banned. But 14% were menthol cigarettes. So this speaks to the demand as well as the presence of these illicit products being found in these areas after the flavor ban. When we look at the tax determinable packs, we can see that a little less than half were not from California. 8.7 were domestic, non-California, which means they came from different states, with most of those coming from the neighboring state of Nevada. And 68% of those were menthol. which again gets at cross-border activity that circumvents the ban. And worth mentioning is 36.6 were non-domestic, so from outside of the country, either being duty-free or from a brand that came across the southern border of Mexico. And then when you look at flavor devapor prevalence, 97.9, nearly all of them, were flavored and illicit. So these discarded pack studies show that a lot of illicit product is being found after these flavor bans. and some suggestive evidence that they're coming from cross-border activity. And then the last pillar is tax revenue in response to flavor bans. Tax revenue reports allow for assessments of increases or decreases in tobacco tax income based on the locality. We're going to look at cigarette taxes here. The reason being that a lot of states group their taxes together to where you can't disentangle whether it's vapor, cigar, or other products. When we're looking at cigarettes here, it'll be implications more on the menthol aspect of the ban. But what we see is that localities with flavor bans experience decline in tax revenue, while adjacent areas see corresponding increases, and that alludes to cross-border activity. So we're going to start with Massachusetts, and this figure on the left is the total cigarette tax paid sales change from the year before to the year after the flavor ban. Massachusetts is in red, and you can see the surrounding areas. Now, Massachusetts lost 33.1 million tax patents. That's a 23.9% change, $116 million. And the surrounding states of New Hampshire, Rhode Island, and Vermont gained 29.9 million packs. So that's about 90% of what Massachusetts lost in just those three states. And that's highly indicative of cross-border activity. Now, this money that was lost that went to neighboring states, this actually goes to a fund that helps fund health care initiatives for the Massachusetts citizens. So this actually led to a loss of money for helping health care for the people that live in this state. And then our last bit of evidence here is for DC. On the left is the cigarette excise tax collections in Washington, DC over the last 10 or so years. And you can see two time points that were followed by pretty big decreases in tax revenue. The first one was a $2 a pack tax hike, and the second one is the flavor ban. And that flavor ban was followed by a 66% decrease in excise taxes in the years that followed. Now, D.C. is a small little area with expensive cigarettes surrounded by areas with cheaper cigarettes. So cross-border activity has been going on for a while here. But we're going to look at a certain sales data point to really show you how people reacted to this particular flavor ban. So that little red dot right there is Hanover County. It's about an hour and a half from D.C. And in the year after the ban, they had a 30% menthol sale increase of about 853 hundred thousand packs. Now DC sold about 937,000 menthol packs before the ban. And so this single county accounts for about 91% of DC's lost packs. So again, highly indicative of cross-border activity. So I hope that I've been able to provide case studies across different states, different localities, different data points that kind of shows some of the unintended outcomes or what happens with these slavery policies in the US. And it's kind of bulleted into three different points. We saw that overall adult smoking, cessation, menthol use was unaffected. We saw that in our behavioral data, but we saw that it might have actually hurt certain groups. We saw that underage smoking and cessation was unaffected. And we also saw that illicit and cross-border products flourish. So the ultimate takeaways are that flavor bans have not delivered clear reductions in smoking, and that illicit market and cross-border activity blunts policy impact. So thanks.



25:07 - 25:19


[Mohamadi Sarkar]


Are there any clarifying questions? If not, we'll just wait till the end of the presentations for a panel discussion. Questions? OK, Marina.



25:26 - 34:56


[Marina Murphy]


Hi, everybody. My name is Marina, and I work for a company called Hype Group, which is an e-commerce platform specializing in nicotine products. Am I doing the wrong thing? So I just wanted to start by talking about the framing of flavors, the framing that we're responding to. So basically, if you think of organizations like the WHO and regulators around the world and how they frame flavors in tobacco and nicotine products. So it's all about the idea of making products more attractive. But their view is we need to ban these flavors because we need to make them less attractive and less appealing. So then the question I think is, but less attractive and less appealing, then what exactly? Because if we're talking about helping smokers to quit, we should be thinking about making products at least not unappealing, or at least appealing enough for people to want to use them in place of a cigarette. So flavors, as we know, are not an invention of the tobacco industry, and they're a very important tool in pharmaceuticals, simply because they basically make things more palatable. So if you think about Pediatric antibiotics, for example. A lot of those will be flavored. Chewable tablets will be flavored, syrups are flavored. Not because you're trying to attract youth, but you're trying to make medicines more palatable and you're trying to ensure that those medicines get to where they need to be, because a medicine not taken is a medicine not working. And, of course, nicotine is medicine, as we know. And the WHO listed nicotine in the list of essential medicines in 2009. And according to the WHO, nicotine is a safe, effective medicine, and they are very explicit in their support for nicotine in nicotine replacement therapies in smoking cessation services. So we know a spoonful of sugar makes the medicine go down, so NRTs are not surprisingly mainly coming in different flavors. So you have a situation now where we have an organization that on the one hand understands nicotine to be an essential medicine, supports the use of flavors for patient compliance, and supports the use of NRTs in smoking cessation. And then on the other hand, the very same nicotine, if it's in a similar product made by somebody else, it's now considered to be toxic, dangerous to youth, and shouldn't come together with flavors. And you have to consider also that these NRTs, at least in the UK, are approved for use by people, anybody over 12. And you don't require a prescription. You can get it over the counter. So they're clearly not very worried about the toxic impacts of nicotine. So like I said, I work for Hype Group, and this is just an illustration of our business model. So we basically sell direct to consumer. So that means that we have loads of transactional data, but it also means that we have access to our consumers. We can talk to our consumers, we see what's in their shopping basket, so we know what they're buying. And we have data from several years, so we can look back over several years to see how things have changed or not, as the case may be. So this is our flavor wheel. So you can see that we sell lots and lots of flavors. We sell a variety of nicotine products, but mainly nicotine pouches. And so in the UK, where I'm based, we sell only nicotine pouches. And as you can see, there are lots of flavors. So we've got 72 flavors here. And I don't know if that's exhaustive because, of course, they'll be switching in and out. New flavors come, some flavors go. But the point is we sell lots of flavors because there are lots of consumers and everybody's different. And everybody has to go through the process, of course, of finding the flavor that works for them. So banning flavors is essentially just banning options. Banning options for people. So if we break it down, these are our three main markets. I mean, we have more than three markets. But in Sweden and the UK, you can see 50-55 flavors, and 29 in the US, which is not surprising given the regulation model you have in the US. It's not so easy to introduce new flavors. The mint category dominates, as you can see. And there are, of course, it says mint there, but that doesn't mean that this one flavor, there are several. There are several mint-type flavors, but that is the flavor that dominates across these markets. And I think what's interesting here is, as you can see, regardless of what age you are and what country you're in, whether you're 18 or 65, the same products dominate, which would suggest that there isn't a strong connection with age in terms of preference for flavors. Because as you can see, again, we know the mint flavors dominate, but we can also see that they're top of the list in terms of preference regardless of the age category. So like I said, we have access to our consumers in a large database. And we routinely ask them what they think about things. what we call a pouch report every year. So we asked across the board, would you oppose or support a ban on flavors in nicotine pouches? And you can see most people say they oppose. I find it actually quite surprising that there are as many people saying they support it as they do. But then, of course, that could be just, you know, people who are already using unflavored products and also people that don't really know what they're going to do, I think. And again, if a flavor ban on nicotine pouches was introduced, what would you do? Well, I think a lot of them are saying they're going to or they would switch to unflavored products or they don't know. Again, I think these kind of surveys are interesting, but they don't necessarily tell you what's going to happen. And then this is just, we ask them what's the top factor in picking a product flavor, not surprising. But this slide I think is important because I'm talking about the UK here and we don't have any flavor bans in the UK. So again, like I said, I think it's useful to ask people, what do you think you would do? But what we do have is a disposable ban. So the first year anniversary of the disposable ban was this week. It was Monday. And we also did a survey asking people what did they do? What did they actually do? And this mightn't be what they thought they would do if you asked them a year ago. So a third of those people are still buying disposable vapes, which means they're buying illicit product. And they come from a variety of places, but the main... The source of those products is still convenience stores. So you can walk around any high street in the UK and you can buy a banned disposable vape. And I think the most worrying statistic was when we talked to people about whether they quit or cut down, I think something like 8% of people said they quit and 61% of people said they cut down. And then you ask them, well, what did you do instead? Well, 41% of those people said that they are smoking. And I would warrant that if you asked them that question this time last year, I don't think 41% of those people would say, actually, I'm going to start smoking. So I think this is more indicative of what is likely to happen or would be likely to happen if you start to think about introducing flavor bans for nicotine pouches. Hopefully we won't have a flavor ban on nicotine pouches in the UK, but I don't know if everybody will be aware, but there is a new act been passed in Parliament in the UK, Tobacco and Vapes Act, And one of the things that that does is give the Secretary of State power to make rules around flavors. And I'm hoping that reason will prevail and that they will look at things like flavor descriptors and maybe make some rules about how things are described so that they're more sensibly or pragmatically described rather than going after the flavors themselves. But who can tell?



35:05 - 36:00


[Mohamadi Sarkar]


Once again, clarifying questions. If not, I thought it was fascinating that both Evan and Marina showed that a sizable proportion go back to smoking. And while we don't have any empirical evidence towards that, but it's possible that these flavor bands have an additional unintended consequence of perpetuating misperceptions. Because a consumer, when they see that the government is banning a product, then the natural place that they may end up is that, oh, that means that the government thinks that this is bad for me. So might as well go back to smoking. So that needs to be further understood. Jag, do you want to share your thoughts on what you've heard from Marina and Evan and just your experiences in India?



36:04 - 40:52


[Jagannath Sarangapani]


It's true. I mean, when you look at the data, and you do see the extent. I mean, I saw the circular wheel of the kind of flavors that are floating around, and the tobacco flavored was 1.9% thereabouts. And that makes sense. I mean, I quit smoking 11 years ago. The first year and a half of my vaping experience was looking for the right atomizer and the right flavor. that would compare with my Marlboro Lights, something which I always spout. I couldn't find it. And to tell you something, unicorn milk actually tastes great. It's an amazing strawberry milk flavored vape. It's beautiful. So it's not just you. I'm 58 and I enjoyed that one while it was available. But that being said, I mean, India, we don't have anything, right? I mean, everything is banned. And yet, they are freely available. Has the industry been growing? Dramatically so. We have more number of vapors today than we had before the ban that was about seven years ago. Estimates from the market are they've probably grown eight, nine x times from before the ban. And they are all disposables. You do have some kits that are coming up, but they are all sold in as WhatsApp groups and informal groups. And we keep getting these lists of products that are available for us to pick and choose from. 99 out of 100 are flavors. And that's what works. Now, the fact that since it's floating around in a social media platform for sales, there is no regulation. And so, of course, you're going to have the spillover to the youth and so on. But then the youth is a situation that we are always going to have. whether it was cigarettes, whether it's alcohol or anything, now the compulsion for youth to try exists. And I'm not saying we gotta ignore that one, but to say that the vast majority of adults who need alternatives to quit need something which is, what would be the right word? something that you would find attractive enough to move away from a harmful to a less harmful product, I think you definitely need to have these flavors available. And taking them away is not going to solve the problem. Evidence suggests that. Evidence shows that. I mean, evidence also has shown that unintended consequences. It did not drop the way it should have. It just started coming from elsewhere, exactly what's happening in India. We've had a ban, everything is banned, and yet things still come in because the users who want to use will continue to use. You can't force them to have a non-flavored vape. So that's the problem that exists, and it's there everywhere. That's one of the observations that I've particularly had. I mean, I think Henry Ford had said, I will sell you a car of any color as long as it's black. Did it work? So that's reality. People like variations. People like flavors. What helped me quit? It was a fruit flavor. And if it's a nicotine pouch, I like citrus. I don't think I'm going to enjoy an unflavored nicotine pouch. And I certainly am not going to enjoy an unflavored vape. I know a couple of my friends do, but that's a rarity. You can't take exceptions and make that the rule. I think that is something that we all need to remember as we move forward in this. Bands don't work. They're not working in India. They're not working anywhere. History has to show you're just pushing the problem away from something which is regulatory to something which is a policing issue. That's all you're doing with bans. And that's exactly what's happening everywhere where there's talk of regulating, banning, flavors, and so on. That's the problem that we have. We're not addressing it right. That's the thing that the policymakers should be aware of and should focus on.



41:10 - 59:19


[Ryan Seltzer]


All right, yeah, we're gonna talk about population modeling today and its impact on flavors and on harm reduction in terms of viewing the, analyzing the impact that some of these flavors have at the population level. Disclosures, my company Safety in Numbers provides statistical analysis methodology and database management services for research on nicotine-based products. OK, so we're going to talk about population modeling. So the question is why, before we even get into what it is. And really, I want to take a step back and look at this central question, which is the cost benefit of these alternative nicotine products. And so I think the benefits are pretty well documented on harm reduction. So just some examples are we have toxicological risk. We see that the cancer and the non-cancer risks are dramatically lower. with these alternative nicotine products compared with combustible cigarettes. And then we look at switching studies. We see that in a lot of research that's been done that it really does help smokers quit and much better than a lot of the nicotine replacement therapies. And as Jack was saying, a lot of these products are just more appealing and more useful to people as they're trying to make the switch from combustible cigarettes. So there are a number of examples here. I just listed two. And then there's also the other side of the cost situation is the risk of youth and young adult initiation. And so we get this information from TPPI studies, from initiation, rates, vaping counterfactuals, where there's the idea that we can estimate that says, oh, these vapers would not have smoked cigarettes at all. So the introduction of vaping is just you're not benefiting. There's no benefit of getting them away from cigarettes because they wouldn't have smoked cigarettes at all. something that's been proposed as well as the gateway hypotheses and different variants of that that would lead to smoking cigarettes. So that's sort of the risk aspect of this cost benefit. analysis. And so what we really want to do, and to answer some of these questions, is to gauge the cost benefits of each of these different scenarios that we have, or the research elements of that. But we want to be able to integrate it all, essentially, because it's not terribly valuable from a population level to be able to say, yes, look at how much better vaping products are at reducing the risk of cancer, and then ignore everything else, or just looking at one thing and not really considering that there may be risks for youth initiation, that sort of thing. So we do want to be able to gauge each of these different scenarios, like the switching and the toxicology, but we also want to integrate everything into a larger scale assessment. And this is sort of aligning with what the FDA wants to do with the idea of appropriate for the protection of public health. So overall for the public, are these products better or are they worse? So when we look at the population level of tobacco harm reduction, basically what we're looking at is, again, it's APPH focused. And what we want to do is compile what is known and project this to the whole population. Because again, we know that these products are beneficial for this person or for this subgroup. But we want to know, what are the overall effects for the entire population? Does this have a much larger scale benefit? And this is where population modeling is designed to really do, is to assess the public health costs and benefits for everybody and not just a select group. Okay, so how do we do it? So we're looking at all these different areas and we're gonna integrate the multiple domains of the product research to estimate these public health outcomes. So we have switching studies, cessation rates, TPPI, QRA, quantitative risk assessment, that's the toxicology piece, initiation, all of these different areas are we're gonna integrate them and use that, use all of these in composite to make an APPH evaluation. And that's really what we're doing with population modeling. And as Mohamadi said, you know, that's why, you know, we're talking about all these different pieces and then we're going to pull everything together using this approach. And so what's really cool about this approach is that we're going to use product-specific inputs from all of these different studies. So the population models, it takes these inputs or the findings from each of these studies, and it can run simulation to then estimate the population level outcomes. And it's these inputs where we can get the evaluation of flavors and how that can get specified. So we're talking about, you know, prohibition, you know, flavors, all these things that are going on, we're able to make very specific estimates of these types of prohibition activities at the population level. And this is why I think it's a really powerful method to work on, because as the figure's showing, many different areas are able to contribute to this one overall conclusion. So we're balancing the costs and benefits. So yeah, in the current regulation landscape, there's an interest in estimating public health outcomes for specific products. So when we're trying to get products authorized, it has to be done at the product level, not at a category level. So we really want to say, OK, what is the population effect of this particular flavor produced by this particular manufacturer at this particular strength? And so one of these options is the smoking and vaping model. And this is a validated simulator for population modeling. And you could just see, this is just an example screenshot of what it looks like, but you may recognize the top. I mean, this is an Excel, it's in an Excel document, which is really cool because it's very accessible. And then, let's see, is this a laser pointer? I don't want to... Okay, yeah, so over here... Yeah. So, you know, they're just different inputs. You can input the relative risk of your specific product, the switching rates for your specific products. And then, you know, once you click on these, it takes you to just, you know, different tables where you can enter. And everything's entered by age and by... by gender, so you can get a lot of precision in the different rates. So it's not just one switching rate, it's here are the switching rates for this product from 21 to 25 and from 26 to 30, that sort of thing. So this is an example of a population model, but there are many other different population models that exist, and a lot of times they work on different outcomes and different scenarios, so it's a really great tool that has become very flexible. And I'm just gonna give an example of this SAVM model. But that's sort of what this specific is, is based on the SAVM. But most of them, what they do is they take this similar approach, which is comparing a base case scenario where you have only cigarettes available against something where you have additional products available. And so this is an example of the base case where it's a very similar transition structure. We have never smokers. They initiate, become current smokers, and then they quit smoking and then they become former smokers. But in this alternative modified case, it can become really complex and this is just an initial one based on Levy's initial paper for the smoking and vaping model, but you can see you start out as never, now you're able to move to current smokers or you can be a current nicotine vaping user. You can completely switch to NVPs. You can become a former smoker, you can become a former NVP user. There are just all these different types of transitions that you can make. And again, this can become as complex as you want. And again, there are many models that are much more complex and it really depends on what it is that you're studying at the point and what sort of outcomes that you want. But the standard outcomes really are, again, you're comparing against the base model with an availability where you have alternative nicotine products. And so you're looking at deaths averted, life years gained, and often smoking prevalence. So again, these are the differences. You'll calculate the number of deaths in the base model, the number of deaths in this alternative modified case model, and then you end up saying, with the presence of vaping products, this is how many deaths averted. You got this how many life years gained. We were able to reduce the smoking prevalence that sort of thing. So this is really great for tobacco harm reduction models because it really does show the potential benefit of whatever product you want to do. So you can make it general product or a specific product as well. So it's a really useful tool to integrate everything. OK, so how does it work? So the first step pretty much is to combine these research as inputs into the model. So this is sort of what I was talking about earlier. You have these base case inputs. So you've got the population size death rates, prevalence of use. Everything is going to be sex and age specific. in the input, so you're gonna input all this information, which a lot of times will come from the literature, and then you have this modified case for your specific product, and this is gonna be the scenario that you're comparing the base case against, and you will look at probabilities of smoking and initiation cessation. Sometimes they're not product specific, they don't have to be, and you can obtain it from the literature. But there are options for product-specific switching rates. So you may have done an RCT about switching. So a lot of these are standard things when you're submitting a PMTA application. You want to have an RCT. You want to have a TPPI, a quantitative risk assessment. So all of the information that you're gathering as part of research into a product you're able to use as inputs. So again, switching rates, well now you'll have switching rates for a particular variant, a particular flavor, and again by age and sex, so you're able to add that into the model. Initiation and cessation multipliers, again these come from TPI studies and RCTs, and then you'll want to enter the relative mortality risk, and again, these come from the risk assessment. So you have a lot of the stuff that is gonna be used as inputs into the model. So what happens is, once you put these into the model, like that SAV model that I showed, you will get the outcomes that you're looking for, but they're not necessarily gonna be the product-specific outcomes that you want, and the reason being is that It's going to be for the whole population of users. So a lot of these models initially, early on, were used to say, what is the effect of having ends on the market? And they weren't really designed specifically for a product. So when you run this model just using the inputs, you would basically get, here are the outcomes if every product had the same profile as what you had just entered. So if everybody used this product, this is what it would be. And so that's not necessarily the case, because you don't have 100% market share. So you might say, all right, for this particular product, let's say we have about a 5% market share. So let's add a multiplier on top of that. on top of those outcomes, and so we'll just take, so let's say there was like five million deaths averted, let's just multiply that by 5% and that will be for our product. The only issue with that is, so let's say you have a 5% market share, that's great, but maybe 1% of that is from youth initiation. So you don't want that counting towards your deaths averted and your life years gained because that's the potential cost of getting youth involvement. And you want to sort of subtract that out and not to actually have that included or added to the life years gained. So what Nate Holt et al had done was created an adoption ratio where basically they're simultaneously accounting for the benefits to smokers with the risks of initiation. And you're just basically dividing it. Here are the people who are intending to use the product to quit smoking divided by the people who are intending to use the product who have never used the product before and usually a young adult. What you can do with the SAV model is sort of have a modified adoption ratio, which calculates it the same way. And so you're multiplying the outcomes by that. So if you have a 5% market share, you're not necessarily multiplying the outcomes by 5%. You may be multiplying it by 3.7% or something, because you want to make sure that you're treating youth initiation as a negative and not a positive. So again, the key here is using both inputs to generate the model and then multipliers to the outcomes of the model to get product-specific numbers. So here's just a general example of what these things look like. I'll be presenting product-specific numbers at a different conference in the fall. But you tend to get outcomes that look something like this. So again, cumulative smoking attributable deaths over time. So this is maybe the year. where you start, where the products are not available, then 2050, 2075, 2100. And so, you know, by the time you get to 2100, you can see, wow, there are, you know, over 1.6 million deaths that have been averted by having this specific product on the market. And again, it can be a product, it can be a flavor, whatever it is that you want, you just want to tailor it to how you're working with it. And then life years gained as well. So almost 25 million life years gained by the year 2100. So it's good you get to see it going up every year. So for conclusions. Again, you're using product-specific inputs to simulate outcomes at the population level. And both of the inputs and the outputs are incorporating the benefits to adult cessation and the risks of youth initiation. there is a potential net benefit. They hold under a range of sensitivity models that varied input parameters to very conservative variants. So this idea of sensitivity analysis is very important because we're talking about population level. There's very little to get a, this is not like doing a randomized control trial where you have these people get the placebo drug and these people get the treatment drug. We're talking about populations. you know, thousands, you know, hundreds of thousands of different variables that can affect all these things. So we don't know exactly, you know, it would, we couldn't say having this product in the market saves this exact number of deaths averted. We're just sort of getting it, you know, kind of close. And so we run this research to get a lot of the inputs like switching studies, but we don't know, you know, we get like an 8.7% switching rate. Okay, well, maybe it's not exactly 8.7%, over the next 100 years, maybe it'll change a bit. So we do sensitivity analysis where we run the models using different inputs. So we're gonna say, okay, let's assume our risk analysis, our analysis for the toxicology says that the cancer risk is 1% of cigarettes. But let's just run it again as if it were 5% of the risk of cigarettes. And then for the switching, we say that it's a 9% switching rate for this age group. Let's just say that it's low. Let's say it's like 5% switching rate. So you're really trying to gauge all the different ranges of plausible and even hyper-conservative numbers there so you really have a sense of, in the worst case scenario, would this still be a benefit? So sensitivity models are very important and they really are at the heart of of population modeling. And then finally, the conclusions, they're based on outcomes that relate to the appropriateness for the protection of public health. Again, the purpose of this is to really gather all different areas of evidence, and then to make one sort of overall statement that says, overall at the population level, this is what we're likely to see. So acknowledgements for people that helped me out, and thank you very much. for listening, and we'll take any questions.



59:31 - 61:15


[Mohamadi Sarkar]


OK. So let's start our discussion. Any questions, first of all? Any clarifying questions or any follow-up? This is a rather quiet audience, I must say, so I'm going to prompt some questions for the audience. I know that we have some questions for the panelists to provide an additional viewpoint, but they've been talking all this time. So let me ask you a question. How many people in this room know of or have somebody who was either a smoker or is a smoker and was a smoker and has moved to a less harmful product. That's amazing, isn't it? So you can all kind of relate to this experience. And I'll put you on the spot, for those of you who don't know her. She is Jag's wife. And I would like to hear your perspective. Because look, when you think about somebody who has actually been through this, you know, shared experience of looking at somebody who's smoking, and if it's a loved one, and you really want them to quit, change that habit, and not only because you want for their health and benefit, and not only for that, but for your own health and benefit, because, you know, somebody smoking, the premature death is inevitable, and if we can get them to switch, that just prolongs a healthier life. So tell us your experience.



61:16 - 62:27


[Munira Jagannath]


Hi, I'm Munira. I'm Jaggi's wife. And Jaggi has been a smoker for a long time, reached a point where he was smoking almost 40 cigarettes a day. And he was really, really very unhealthy at that time. He could barely even run a kilometer. He was that unhealthy. So switching from 40 cigarettes to vaping for Jaggi has been absolutely transformative. He now is the fittest he has ever been. He takes part in competitions like High Rocks and all, which he could never do before. And genuinely speaking, his x-rays used to have spots on his lungs. Today, they are completely free, so I am really, really happy. Would I prefer it if he was completely nicotine-free? Yes, why not? But as an improvement from heavy smoking to vaping, definitely, yes, I'm very happy that Jaggi is now doing this. As regard to this flavor band, well... Would Jaggi have given up smoking and taken up vaping if only tobacco flavored was available? Maybe he would have tried it in the beginning. But for him, the flavor was very important. Finding the right flavor has helped him to stick to this. Otherwise, he may have given up. So I am quite happy today with what has happened in Jaggi's life. Yes.



62:29 - 62:44


[Mohamadi Sarkar]


Thank you. Thank you. Any comments, any reactions from the audience? Yeah. Let me give you the mic. Introduce yourself.



62:44 - 63:37


[Pritika Kumar]


Hi, I'm Pritika Kumar. I'm with PMI US. But I'm mostly asking this question to Jagannath for, as somebody from India originally, I have several family members who still smoke. My brother recently transitioned thanks to ICOS, but that ICOS was confiscated in customs when he was traveling domestically in India. So what does the enforcement look like Because I also know that, you know, corruption is still pretty rampant, despite what Prime Minister Modi claims. And people are still able to get their, you know, things that have been not by customs out of the customs and get them back even. So what does enforcement look like? And what do institutions like Public Health Foundation of India, what is their, you know, take on all of this?



63:38 - 67:14


[Jagannath Sarangapani]


Well, what these bands have really done is just shifted everything that was available over the counter to under the counter. So now everything is available. You can get your ICOS. You can get all your refills. You can get just about anything you want. The only thing that you find it a little difficult is to, for example, get your wires for your own atomizers and so on and so forth. But then you just, I'm here, I'll buy a few coils and I'll be fine for a long time to come. So that's one side of it. Now, what's enforcement like? Enforcement, this has just become a tool today. So what you have done by creating this policy The minister was very clear when he announced this that personal possession was not a crime. But that's a grey area of interpretation. If I have more than one, was it for trade or was it for personal use? And that's the kind of grey area that we have. And so all this has become a tool for... the beat cop to harass a user if caught with a vape on the street for a few thousand rupees. That's the only thing that's happening. It gets caught in the airport. You have to fling it away. I've carried a couple of them by mistake. I had to get rid of them. I have found ways to work around it. I used to carry it with my electric toothbrush and so on for some time. But then the AIs have started getting smarter, the X-rays. So they've started detecting them. And so we just find ways to circumvent. So that's where we are. Enforcement is only to, it's just another tool for the cop to make money at our end. What are the agencies doing about it? You'll typically find them all waking up and shouting and screaming on World No Tobacco Day. And just around that time, that's when they all wake up and they talk about the youth vaping scenario and so on and so forth. And then it all just goes away. You will hear this once in a while that a consignment of 500,000 vapes were confiscated. And they come up with numbers that are not close to reality because we see the numbers that are floating around. There isn't a corner in India where you can go or walk into a bar where you don't find people using vapes. And so that's very, very, very consistent. And availability goes by word of mouth. So I find a vaper. I'll ask him where you get it from. You're a little nervous if you don't know the person. You don't know who he is. But then you normally find connects and groups. And these are available. And that's available across the board with all NRTs, whether it is NIC pouches, whether it's ICARs, HTTPS, vapes. You get them all. Absolutely get them all. You still have brewers who are still making their juices and also selling it to them. So you still have these people doing that stuff. So it's not gone at all. It's all available. That's where we are.



67:21 - 67:48


[Jeannie Cameron]


Thank you. My question's for Marina. Working for a company that you do that supplies to the countries that you mentioned, Sweden, US and UK primarily, you went quite quickly through the slides. So I was wondering if you could highlight any sort of differences, either commercially or flavour choices or things between the three different countries and what you see as patterns emerging from what you see in the company.



67:53 - 71:53


[Marina Murphy]


Well, I'd have to go back and look at the slide. Well, you could see that the figures were similar for Sweden and the UK, 50, 55 different flavors. And of course, those flavors won't be the same flavors all the time because the markets are, you know, those markets are very dynamic. So there's this one. Is this the one you're interested in? Yeah. Well, yeah, I mean, there's obvious differences. I mean, Sweden, of course, is the home of nicotine pouches and snus. So there's a very supportive environment there. And of course, it's a very well-established market. And the US is a huge market, the biggest market in the world. And the UK is growing. Like I said, we only sell nicotine pouches in the UK and we only sell online. And actually... The online actually represents a very small part of the UK market at the moment. Maybe 10% and 90% is offline. But that's growing really quickly. So the online channel is growing a lot faster than the offline channel in the UK. In the US... As we know, it's a fairly restrictive environment where you're required to get a PMT, AMRTP, etc., which is why you don't see as much variation. But there is, of course, a huge illicit market problem. But we have seen some movement there, and it does look like things will loosen up a bit, so we could start to see a lot more movement quicker there on the nicotine pouches. Yeah, so they are very different. And I think the thing with Sweden and the US is they're pretty well established markets. And when you look at the studies coming out, looking at who exactly is using nicotine pouches, you see similar patterns regardless of the market. that they tend to be used by people who aren't nicotine naive but have used something else. And I showed our presentation yesterday in the science lab where we actually looked specifically at the Norwegian and the Swedish markets and looked at our own data on sales So comparing snus sales and nicotine pouch sales. So since 2018, between 2018 and 2025, and you can see this exact same pattern in both markets where you see the snus, and this is just from our e-commerce websites, but it was a big data set. It was 19 million anonymized transactions. So if you look at the snus sales, you can see it's gradually going down, down, down, down, down. and the nicotine pouches are going up. And it just so happened that when we were looking at this last year, the lines had just crossed in that, at least on our websites, nicotine pouches is now overtaken or displacing. the snus, and it was similar in both markets. And what was quite interesting is when we looked at the gender differences, that's been driven mainly by women. Whereas if you remember years ago when we were looking at cigarettes, and we're looking at cigarettes going down, down, down, you know, in Sweden and snus going up, that change was mainly driven by men. So I thought that was quite interesting. So we're going to have a look again at those stats towards the end of this year or the beginning of next year and drill down a bit more into the different groups.



71:57 - 71:59


[Mohamadi Sarkar]


Any other comments from the audience? Martin.



72:05 - 72:23


[Martin Cullip]


I just want to ask the panel, it's great you've showed us these flavor bands don't work. And we know from science that's done by Abigail Friedman, Michael Pesco, that these don't work. And surely regulators will read those scientific things and know that these flavor bands don't work. Why do they still do them?



72:32 - 73:19


[Evan Winiger]


Any thoughts, reactions? That is an interesting one. I know that I work with some government affairs people. And in Massachusetts, they acknowledge that these are failures, that they haven't worked. They acknowledge that they haven't worked. They acknowledge that the unintended consequences are there. So I think for some of them, in terms of at least the government aspect, it's just like party lines and pride, unfortunately. But I mean, like you said, the evidence is very clear on the substitution effect. We see that both in the US and internationally. So there's really no excuse for it at this point.



73:24 - 73:25


[Mohamadi Sarkar]


Martin, do you have a perspective?



73:32 - 74:02


[Martin Cullip]


Well, it seems to me that their goal is to reduce youth use. They're worried about youth use of vaping. But they know that the flavor bans increase smoking amongst youth. So I just understand why they're doing it. I mean, do they really think, have they really convinced themselves that they've got to get youth vaping down so much and hang the consequences if kids take up smoking instead, which is far more harmful? I mean, they should know that as well.



74:05 - 75:05


[Marina Murphy]


I was going to just say something. The issue of youth initiation, of course, is top of mind, I think, for most politicians when they're talking about these kind of products. And I always think that, I was going to say funny, but it's not funny, that I think it's strange that when they're talking about these kind of issues, their go-to is to regulate the product more as opposed to regulating around enforcement or regulating around access because the products are for adults so it shouldn't actually technically make any difference what color the product is what flavor the product is if the access issue has been resolved but the go-to for governments seems to be to go after the product to start restricting the product rather than properly restricting the access to the product



75:09 - 76:05


[Mohamadi Sarkar]


Yeah, I think that some of it could be just ideological, and perhaps the view being that we want to create a nicotine-free society, where if you kind of, smoking rates are declining at a rapid rate, at least in the US, and people are alarmed that instead of completely eliminating all tobacco products, now there is proliferation of safe for nicotine products, but nicotine is bad for you, so let's get rid of everything, and this is kind of just a blunt policy that supposedly is to curb any and every nicotine use. I don't know, but, and oftentimes, you know, it's frustrating, right, because Policies should be based on science, but it's the other way around. Go ahead.



76:06 - 77:21


[Ryan Seltzer]


Just one other point about that. I think, in a sense, it's also just a human thing. And from a science perspective, there have been attempts. It's very clear that people get attached to what they're trying to prove. And in the early 1900s, there's this phrase called the paternalistic affection for your hypothesis, and that people will defend their hypothesis even in the face of conflicting evidence. And so from a philosophy of science perspective, one of the approaches was, well, a way to do this is start and have multiple hypotheses. So you're not all in on just this one thing. So a lot of times, good research would say, have five different hypotheses that you're working with. And so if one of them is not supported, then you're not completely gone. But what that does, I think, mentally is it takes the pressure off of having to, you know, your career is not dependent on this one thing. So I think, you know, you just see this a lot with science. And I mean, really, again, I think it's a human thing that people just get attached to things. And, you know, it can be a little difficult to just 100% look at the evidence and then walk away if it's at all different.



77:24 - 77:55


[Mohamadi Sarkar]


But one question I had, perhaps for the panel, but directing to Evan. So you showed statewide data and there's cross-border proliferation. If I am playing devil's advocate, I would say, oh, that's great because that calls for a nationwide ban? We've seen some of the examples in the UK, but what do you think a nationwide ban would result in? Because at least you get rid of these cross-border.



77:56 - 78:55


[Evan Winiger]


I think when you look at the science, the nationwide ban would really result in a lot of the stuff that I showed, which is illicit markets, substitution effects, and a lack of real behavioral change. There was that study in the Netherlands that was referenced yesterday that showed that banning flavored e-cigarettes led to 10% of users switching to combustibles and 6% initiating, but still about half of the products used were flavored products. And then when you look at menthol bans in countries that have done it, you see a... a lot of self-mentholation and menthol additives, and you see some studies that show that it didn't reduce any menthol use and that it didn't also have an impact on quit attempts or anything like that. So I think nationwide bans, from what we know and what the science tells us, would really show a lot of the same type of unintended consequences.



78:58 - 79:43


[Jagannath Sarangapani]


I mean, we have nationwide ban in India. You don't see it working. It just comes from across the border. And like in the case of California, one of the statistics was that a lot of it came from the southern part from Mexico, right? You're going to find exactly that happening in the rest of the country. The US has humongous borders. And you can't police all of them. And so I don't think a nationwide ban is going to ever support a hypothesis of numbers going down. It has shifted. The tax brackets have shifted. The other states are picking up the revenue. Now it'll just be outside the country who are earning it. And that's about it, really.



79:48 - 80:16


[Mohamadi Sarkar]


Ryan, in the model that you showed, You mentioned about this sensitivity analysis. Is there a way to tease out the risk benefit analysis where you could essentially do a computational assessment of if hypothetically the risk of youth initiation continues to creep up, at what point would we reach kind of a tipping point?



80:17 - 81:03


[Ryan Seltzer]


Yeah, that's really great, because in these models, there are inputs for changing the rate of change. So let's say that, well, actually, you see this a lot with new technologies, with age gating and that sort of thing, is that right now, if the age gating is not in place, you could say, OK, for the years 2026 to 2027, 2028, we're gonna keep the youth initiation here, but now we're gonna drop it quite a bit, knowing that an age-gating product is gonna start coming in to be available in 2028 and on. So you can really change how the trajectory of different types of cessation and initiation, that sort of thing, based on how the model is devised.



81:04 - 81:34


[Mohamadi Sarkar]


So you bring up a great point, and I'm gonna turn to the audience. Can age-gating work in lieu of banning flavors if the concern is youth use of products? Do we think that age gating would be a potential solution that still would allow adults to use flavors, but at least prevent youth from accessing any type of tobacco, right? Be it flavored or unflavored. If not, why?



81:39 - 82:21


[Martin Cullip]


AgeGate, and what you can see in America with the FDA, their recent authorizations of those glass products, and there was this AgeGate, and you have to download an app, and you have to sync the device with the app and everything else. There's people, older people especially, who just won't do that. They just don't know how to do it. I know people who don't even know how to use their mobile phones, who are older people. Young people will do it fine. They'll have no problem with it at all, but older people won't. So it goes against older people using those devices. I don't think age gating is something we should go towards. But then that's from a consumer perspective. I'm not talking from a regulator's perspective.



82:27 - 82:45


[Attendee]


I do. I mean, we already know it doesn't work if you look at other products. Like taking the US as an example, alcohol and cannabis are still used at much higher numbers by youth than e-cigarettes and nicotine pouches. So I mean, it's a nice thought, but I think we already know the answer.



82:47 - 83:17


[Marina Murphy]


I think age verification is very important. And that's what I mean by properly regulating access rather than trying to restrict the product. But I think age gating products, I would agree with Martin, I think that's a step too far. Because it does, it just has thrown up barriers for people who are trying to use it or learn how to use it or switch. But I think age verification or age gating at the point of sale is what you want to happen. And for it to happen consistently.



83:19 - 83:43


[Evan Winiger]


Yeah, I would agree with that. And we see that with other products, like states in the US that have strict cannabis legalization actually have youth rates go down and not change as a result of that. So definitely, age verification aspects are very important for keeping these out of the hands of underage individuals.



83:46 - 83:53


[Mohamadi Sarkar]


Besides, you would be able to do educating on things Age dating of nicotine pouch cans is a technological change.



83:53 - 84:00


[Marina Murphy]


Well, I'm sure they could come up with a way that you have to use your biometrics to open your can or something. I'm sure if they really wanted to.



84:02 - 84:28


[Mohamadi Sarkar]


So in closing, if there are any normal comments, maybe we should give the panelists just one last few seconds to share the perspective. And the question is that if you were to meet a policymaker and want to convince them that this is a fatal flaw in their thinking, what would you say?



84:32 - 84:54


[Evan Winiger]


I would show them the vast amount of research that shows that these bans don't work. I would show them a lot of the substitution effect, primarily for the underage individuals with the research that's published on that. And then I would focus on, you know, having proper underage prevention efforts in place, if that's the main issue that regulators are worried about.



84:58 - 86:17


[Marina Murphy]


In the UK specifically, we haven't a flavour ban, and hopefully we won't, but like I said, we do have the disposable vape ban. And, you know, we did a survey, but we weren't the only ones who did a survey. And all the surveys had similar results, that there was high numbers of people who either started smoking or went back to smoking. But the other thing, unrelated to that ban... but related to vaping and to the sort of scare stories that we've seen proliferating in the last couple of years. There was also, not too long ago in the UK, a sudden spike in teenagers smoking. because of the massive focus on vaping, on teenagers vaping, and the media storm around vaping and how harmful it was. And, you know, it had the opposite impact. People were so focused down on vaping that they'd almost forgotten about smoking. And then, unbelievably, after years and years, you see a spike of teenagers smoking.



86:22 - 87:29


[Jagannath Sarangapani]


Well, in my case, it's obvious that the ban hasn't worked. And so I would advise them to show some courage and get into basic regulation. Start with something easy, which can be controlled and monitored, and rather than making it a criminal offense. Because right now, you're overburdening it into a law and order thing. If you take it into regulation, I think that would become much easier. And you start with something small. That will make it easier for you to control the youth getting access to such products and so on and so forth, which is something that we had. We had no regulation, but we had self-regulation as the sellers prior to the ban. So we had this kind of practice that was going on. And I think it's time that the government should show a little bit of courage to admit they're wrong when they're wrong. I know it's tough, but I think that would be a start, really.



87:31 - 89:00


[Ryan Seltzer]


Yeah, and I think there's a lot of room to just be precise in how some of these things get enacted. And there's so much research that's been done. We can really say under what circumstances, what populations, that these things are going to happen. So if you're concerned about young adult initiation, if you're concerned about this, we really understand, I think, the circumstance that that happens. And so to be able to... be able to use that strategically. And I don't remember the details of this example, but I just think it's good. At one point, I guess, Albert Einstein was looking for some celestial object. And rather than just saying, to support the hypothesis, rather than just saying it exists or it doesn't, he had said, it's going to be in this specific place at this specific time for these specific reasons. And then that's how he was able to show, yes, this thing actually does exist. Because the precision that he gave for the reasoning behind it, there was really no doubt that that's really what it was. And I think that we're gathering the information of who switches, when they switch, under what circumstances, that if we were really to try to defend these things to a regulator, instead of just saying, hey, this is a lot healthier than smoking cigarettes, and say, OK, here's a strategy. Here's why it's going to work. Here are the reasons why. And then here are the circumstances to using it. I think that we have that ability now because the research is so precise.



89:03 - 89:05


[Mohamadi Sarkar]


On that note, a round of applause.