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Sweden’s success with snus and now nicotine pouches proves tobacco harm reduction is a model for helping millions quit smoking. But there’s a secret behind this success. Shot on location at GFN 2025 in Warsaw, Poland, we speak with Anna Franzén and Tomas Hammargren of Emplicure about the big questions surrounding nicotine policy and the realities of recreational use.


Transcription:

00:10 - 00:49


[Brent Stafford]


Hi everybody, I'm Brent Stafford and welcome to another edition of RegWatch on GFN.TV. We're here in Warsaw, Poland for the 12th edition of the Global Forum on Nicotine, the annual conference on safer nicotine products and tobacco harm reduction. In this episode, we're going to be talking about nicotine pouches and the critical role they play in harm reduction. Joining us will be Anna Franzen and Thomas Hammergren from Emplicure, which is a Sweden-based company that's innovating in the nicotine space. So let me ask you first, Anna, you're a toxicologist, toxicology background. How is that connected with Emplicure?



00:50 - 01:26


[Anna Franzén]


So I would say that overall it's from a risk benefit assessment side. So it's important to understand what nicotine is and how it can help and reduce harm and what's the maybe adverse things with nicotine and do a proper risk benefit. And I have worked a long time within the pharma and within regulatory authorities within medicines to to do these kinds of risk benefit assessments. So that I think is maybe the single most important thing that I bring to the company.



01:27 - 01:32


[Brent Stafford]


And this is nicotine, right? Yeah, it's nicotine. So what are the risk benefits of nicotine?



01:32 - 01:50


[Tomas Hammargren]


It's very much in the delivery, how it's delivered. I mean, if you smoke for nicotine, it's really bad for you. A pouch with nicotine, that looks very different in the risk assessment. So what is Emplicure?



01:50 - 02:30


[Anna Franzén]


Well, Emplicure is... Do you want to start? Yeah, I can start and you can fill in. So Emplicure is a bioceramic startup company. So it's a biotechnology company from the beginning. It was founded by Professor Håkan Enqvist, who is a professor at Uppsala University within the material science. And it started actually as a pharma company and we have tested this bioceramic material for different active pharmaceutical ingredients. And nicotine is one of those ingredients that they found worked very, very well together with this material.



02:31 - 03:00


[Tomas Hammargren]


And maybe we can say that in the first five years of the company, it was really focused on pain relief substances. And then there started to be an interest five, six years ago to look at other components and nicotine was one of them. And it turned out that nicotine and this bioceramic material we have works really well together. So what is bioceramic?



03:01 - 03:42


[Anna Franzén]


So it's a biocompatible material. So it has been used for many, many years within the dental, for dental implants or for bone implants. So it's a very, very common material. And it's also been used within the pharma industry and also as a food additive. So it's really, I mean, according to FDA, it's a substance that is generally recognized as safe. So I think the new thing is the technology here and how we produce it and how we use it, how we incorporate the nicotine within the material.



03:43 - 04:16


[Tomas Hammargren]


So it's the type we are using now. They are proprietary. I think it's very porous material. You can say in the production we can choose size of the pores and how much we fill the pores with nicotine that will create different type of release profiles. So that's the technology that we have done during the latest five years intensively been working on how to make the best possible nicotine pouch.



04:16 - 04:27


[Brent Stafford]


And that's what I was just going to say. We're talking about a pouch. Yeah. Correct. Yeah. So we're very popular. You're from Sweden. The company is from Sweden. Yep. Right. So you've got all of that background from the snus.



04:27 - 04:27


[Anna Franzén]


Yeah.



04:28 - 04:35


[Brent Stafford]


Right. So how is this different than, say, a nicotine pouch, you know, non-tobacco based nicotine pouch?



04:35 - 05:35


[Tomas Hammargren]


Basically all nicotine pouches today are cellulose based and when you work with cellulose it has some drawbacks. One is the type of nicotine release, how much nicotine it actually releases. So if you fill it with 100 maybe it just releases 40-50. And also the speed of release. We saw some room for improvement and that we've been able to show now. So even we're a small company, it's not very common that a small company does a so-called PK, pharmacokinetic study, actually look at the blood and blood analysis on nicotine uptake. We have been able to show that we have a faster onset of nicotine and a very clear indication that our bioceramic material delivers more nicotine. So the conclusion can be that we can do more with less.



05:36 - 06:19


[Brent Stafford]


I always think back to the Royal College of Physicians, Dr. John Britton, back in 2016, when they just came out with their big study on tobacco harm reduction and vaping. Nicotine, or was it nicotine without smoke, I think is what that was. And he would describe, and I was a little, it was a bit incredulous at the time about how important it was for the nicotine to get to the brain as fast as possible. And I'm listening to a doctor telling me this and I'm going, wow, I'm kind of shocked. And all we hear about now, you know, in the save the children kind of a world is that, you know, nicotine, faster nicotine has somehow been designed to hook kids quicker.



06:19 - 06:33


[Tomas Hammargren]


I think you have to put it in perspective because the very rapid thing is what happens when you smoke and a bit closer as well when you vape because the lung uptake is very fast.



06:33 - 06:51


[Anna Franzén]


And the goal here is that to decrease the cravings that you have from these tobacco combustion from cigarettes and these things. And that we believe that with our technology that has a faster release could help that in a better way.



06:51 - 06:58


[Brent Stafford]


So inside a regular nicotine pouch, as you said, it's what kind of fibers or something like that?



06:58 - 07:03


[Tomas Hammargren]


Yeah, fibers. Most of them type of cellulose-based fibers.



07:03 - 07:11


[Brent Stafford]


Right. And so this one is bioceramic. Yep. So it's the thing that holds the nicotine and then releases the nicotine.



07:11 - 07:52


[Tomas Hammargren]


Yes. So we integrate the nicotine in the manufacturing process into this porous bioceramic material. It's very interesting. And then there's another positive effect that with our material, we can make our pouches really small. And we believe strongly that that will help in countries that are not used to oral tobacco or oral nicotine. So if you go to southern part of Europe, I mean to Italy or Spain or Japan, a small pouch would be more attractive.



07:52 - 07:59


[Brent Stafford]


Well, on that then, just in general, how open are countries in Europe to nicotine pouches?



08:00 - 08:33


[Tomas Hammargren]


It's a mixed box. I've been in this space 20 years now in tobacco harm reduction, so I'm probably used to it, the ongoing thing. What we see is it's a mix of countries actually introducing regulation, which is good, very good. And then you have other countries banning it. More type of a knee-jerk reaction, oh, this is growing, we have to protect children, the best way to protect them is to ban it.



08:35 - 08:38


[Brent Stafford]


Is that save the children attitude, has that always been around?



08:39 - 09:03


[Tomas Hammargren]


Yeah. Yes. I mean, we know it very well from tobacco or even snus, Swedish snus. And that was one of the main reasons why snus was initially banned in the UK, which was not because of the Swedish snus, an American version. Then UK brought this ban into the European Union, where Sweden was not a member.



09:05 - 09:09


[Brent Stafford]


But obviously the product made a big difference in Sweden, didn't it?



09:09 - 09:29


[Anna Franzén]


Yes, it has. I mean, now we have under 5% smokers in Sweden. And that is, according to WHO, also the number for a non-smoking country. So that is... great public health achievements. So I think that we really have to remember that.



09:30 - 09:36


[Tomas Hammargren]


I think the average in the EU is somewhere plus 20, between 20 and 24%.



09:36 - 09:46


[Anna Franzén]


Yes, and with that, we have also seen that the incidence of lung cancer in Sweden is much lower compared to other countries as well.



09:47 - 09:50


[Tomas Hammargren]


COPD, cardiovascular diseases.



09:51 - 09:53


[Anna Franzén]


So there is a relation here.



09:53 - 10:21


[Tomas Hammargren]


The Swedish model. The Swedish model, yes. And it would be great to see more examples. I mean, recently we've seen quite a big shift in Norway. In other countries, let's see what happens in the US now where pouches are getting very popular. It will take some time for the cancer data to come out. The cardiovascular data we'll probably see in a couple of years.



10:21 - 10:30


[Brent Stafford]


Is it not true, though, that we've seen the ATOs, the anti-tobacco organizations, turn up the heat on nicotine pouches?



10:31 - 10:57


[Tomas Hammargren]


Yes. I mean, I think there's been a shift also from FCTC, WHO. Earlier it was kind of anti-tobacco stance. Now it's more like anti-nicotine, partly anti-industry. Is there a war on nicotine going on? A regulatory one, yes. Absolutely.



10:57 - 11:19


[Anna Franzén]


I think it's too different. It's one part that believes in tobacco harm reduction as a good strategy to end tobacco smoking. And the other part thinks that banning is the way to go forward. So it's two different sides here. It's a lot of opinions.



11:19 - 11:21


[Tomas Hammargren]


It's a lot of opinions.



11:21 - 11:30


[Anna Franzén]


So I think that the evidence-based and science-based research for this could kind of solve this problem and we need to discuss.



11:30 - 11:32


[Tomas Hammargren]


At least help. Yes, not solve.



11:32 - 11:37


[Anna Franzén]


That's too much, but help. And the two parts need to discuss it more.



11:38 - 11:49


[Brent Stafford]


So neither of those things, it seems to be tobacco control wants to let the science in and they also don't want to talk about it. Or am I incorrect there?



11:49 - 11:50


[Tomas Hammargren]


No, no, you're right.



11:51 - 11:56


[Brent Stafford]


So that's on purpose then? Yes.



11:56 - 12:56


[Tomas Hammargren]


Yeah, that's my perspective. It is. But again, we at least have some hope in more and more of the recognized scientists actually taking a stance here and they see the benefits and you have a scale of different products and we believe that nicotine pouches are most likely the less risky of all of them. And actually we had some talks about NRTs, medicinal nicotine, that are considered safe and effective in 140 countries around the world. Sweden was the first country that actually had a nicotine pouch before 2011, I think it was.



12:56 - 12:57


[Brent Stafford]


I didn't even know those existed.



12:58 - 13:06


[Tomas Hammargren]


Three years before consumer products came onto the market. And that product is identical to what we work with today.



13:07 - 13:17


[Brent Stafford]


So let me ask you then about the technology and what you guys are doing. Are you trying to get your technology into other people's products or do you have your own as well?



13:18 - 13:20


[Anna Franzén]


Yeah, both.



13:21 - 13:42


[Tomas Hammargren]


Yeah, both. But what we're focusing on now is to build our own brand. So we're since January this year on the market in Sweden. It's our home country, very extremely competitive. And in the UK, we are exploring new markets. What's the name of the brand? Klar.



13:42 - 13:46


[Anna Franzén]


Clare. I actually have it on my t-shirt.



13:46 - 13:51


[Brent Stafford]


Clare. There we go. Do you got anything in 50 meg?



13:51 - 13:55


[Tomas Hammargren]


No, we're not going that high.



13:55 - 13:57


[Brent Stafford]


That's way too high.



13:57 - 14:18


[Anna Franzén]


It's no reason to go that high. And that also, I think that we need to have a balanced and sensible regulation in this because we don't need those products. And especially with new innovations like ours, where we can see that we can have a faster release and we can lower the nicotine levels even more. So we can push that down.



14:19 - 14:28


[Brent Stafford]


You better get that to Canada because Canada's got some pretty low levels for their nicotine pouches. Not quite enough for somebody who's trying to quit. No, it's true.



14:28 - 14:49


[Tomas Hammargren]


And that's most likely one of the reasons why medicinal products have had so much or so low impact. They've been on the market for 50 years and they contain too little nicotine to actually really help smokers long term.



14:51 - 15:14


[Anna Franzén]


And they are targeting the group that wants to quit with nicotine. But we also have a group that wants to continue with nicotine, but wants to quick all the harmful toxicants that's in it. So in that sense... In smoking, not in nicotine.



15:14 - 15:15


[Tomas Hammargren]


Yes, in smoking.



15:15 - 15:24


[Anna Franzén]


I said nicotine. Yes, smoking. So I think that is also important because we need to address those that want to switch and those that want to quit.



15:25 - 16:00


[Brent Stafford]


So you just Anna said something that is so rarely said on our show. There's people out there that want to quit smoking, but not quit nicotine. And they're so often left out of the conversation. Yup. Right. Yes. Well, look at the US. You have 20.5 million people who have switched to safer nicotine products. And what are they going to do if FDA shuts down the entire industry? It's like nobody ever discusses the people who have quit smoking but want to keep using nicotine.



16:00 - 16:47


[Tomas Hammargren]


No, it isn't. Good to hear. I mean, some of the major scientists in the US, like Neil Benowitz, talking about nicotine and actually looking at nicotine from another perspective, that actually, if you get your nicotine with much lower degree of harm, it might actually be sometimes good for you. When you look at concentration, focus, activities, there's some medical indication, Alzheimer, rheumatoid arthritis. And people have not been ready to talk about it because there's still such a strong link between nicotine and cigarettes and smoking.



16:47 - 17:01


[Brent Stafford]


So let's talk about that for a second as we keep getting data out that you know, major Western countries, doctors believe that nicotine causes cancer. How is that possible?



17:01 - 17:13


[Anna Franzén]


Because we talk about tobacco and nicotine in the same sentence, like it's the same thing. We say tobacco, nicotine, or nicotine, tobacco. But it's really, it's so important to distinguish between them.



17:14 - 17:26


[Tomas Hammargren]


And I think adding to that historically, I mean, some 30 years ago, there was massive campaigns in the UK and US with the evil nicotine.



17:27 - 17:29


[Brent Stafford]


Right. They had characters, cartoon characters.



17:29 - 17:38


[Tomas Hammargren]


Exactly. So it's been many years where nicotine has actually been the bad guy.



17:38 - 18:20


[Brent Stafford]


So let me ask you about tobacco control for a second. You know, this amorphous blob of public health bureaucrats that are, you know, there's a lot of good people in tobacco control, but there are a lot that take the control part a little bit too far, right? But for the addictive nature of nicotine and but for secondhand smoke, they wouldn't have anywhere near the control that they've got right now on those two issues. And so people quit smoking. Well, the secondhand smoke is not really there anymore. And so all they have left to hold on to is the addictive nature of nicotine. So should we be looking at recreational nicotine?



18:22 - 18:27


[Tomas Hammargren]


Aren't we already? I mean, Sweden for sure.



18:28 - 18:48


[Brent Stafford]


Well, I would say pretty much anywhere in the world where a cigarette is legal, then nicotine is legal as a recreational substance. Very true. Right. So it's weird. I know you bring up recreational nicotine and some people are like, oh, don't talk about that. Well, a cigarette is recreational nicotine. Yes, of course. Yeah. And it's killing people.



18:48 - 18:48


[Anna Franzén]


Yeah.



18:49 - 19:07


[Brent Stafford]


Oh, it's crazy. NRT is one of those things that has lost, I think, its ability to make an argument, right? Like if nicotine was bad for you, how come then NRT isn't bad for you?



19:07 - 19:13


[Tomas Hammargren]


I think that should be more frequent actually.



19:13 - 19:40


[Anna Franzén]


And we were talking about just before that because with this nicotine as a consumer product we are not allowed to say that it helps you quit smoking. But for the medicinal drugs we are allowed to do that. So that's a marketing thing, a regulatory marketing thing that is important because if we were allowed to say that nicotine alternatives help you quit smoke.



19:41 - 19:41


[Brent Stafford]


Can help you.



19:41 - 19:45


[Anna Franzén]


Can help you quit. That would be very, very good.



19:45 - 19:52


[Brent Stafford]


So how is it that in every country that that's the case? Is that part of the FCTC? Is that like a World Health Organization thing?



19:52 - 20:14


[Tomas Hammargren]


Because... I think it's the definition of the pharma products. If you have pharma, it's been that way a long time, also for other products. You're allowed to make claims. in a so-called pharmaceutical place. And you're not allowed to do that if you only have a consumer product.



20:14 - 20:51


[Brent Stafford]


It seems to me that everything is boxed in. You can't say, you can't Why can't a cigarette company send their cigarettes out with a little message in there that says, hey, try our vaping product. It's safer for you. Can't do that. Can't go do a 30-second ad or a billboard because of all the advertising restrictions. So meanwhile, what happens is that tobacco control just pushes out the misinformation. I mean, you have WHO saying it causes cancer, vaping kills, right on their Twitter account.



20:51 - 21:08


[Tomas Hammargren]


And many of those groups are really skillful in communicating their messages and kind of mixing science. Right. What products are they actually talking about and how do they group them together? We've seen that over the years.



21:09 - 21:33


[Brent Stafford]


Yeah. So if a lay person in the public goes, well, you know, how come I haven't heard this before that, you know, there's such value to vaping products? Well, it's because nobody is allowed to take out an ad to tell you. And we have to rely on the goodwill of people in mainstream media to like, and they're not going to do that. They're not doing that. So it's a real box.



21:33 - 21:57


[Tomas Hammargren]


It's really interesting space to be in, challenging, very. But I still believe in a road forward building on science, more science, more real market data. And one step going that way will be balanced regulation.



21:58 - 22:18


[Brent Stafford]


what's going on in europe with regard to these bands like i've heard spain is yeah banning or they put in nicotine limits so so yeah 0.99 milligrams nothing right so it's it's still some in there but technically it's no



22:18 - 22:50


[Anna Franzén]


No, it's not going to help for the tobacco harm reduction goal. And also, I think this is interesting because I mean, those low levels of nicotine can actually introduce even more youth into the category because it's so low. So you can't, I mean, you can't feel You don't get sick of it. The initial side effects will be much less. Yes, it's a way to initiate the use as well. So it's not black and white here. It's not so easy.



22:52 - 23:23


[Tomas Hammargren]


But the good thing is that lately, the latest year at least, we've seen the Swedish government starting to take a position, being a bit more proud of what has been achieved in Sweden, which was not the case earlier. So that's really positive, especially in advance of the next revision of the European tobacco products directive, expected maybe next year or in two years.



23:24 - 23:29


[Brent Stafford]


Right, so they're going to stand up hopefully for the great work that has happened.



23:29 - 23:36


[Tomas Hammargren]


Yeah, be proud of it. I mean, it's amazing. Sweden is, in principle, a smoke-free country. Yeah.