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0:00 - Intro
1:18 - The Philippines has approved a key Vaporized Nicotine Product Bill
1:54 - What is the FDA doing regarding the regulation of vaping products in the USA?
4:44 - David Sweanor shares his thoughts on doctors and nicotine
6:32 - Study concludes vaping is aless effective quit method - but what are its limitations?
11:26 - Brent Stafford interviews prominent harm reductionist Mark Tyndall
35:18 - Closing remarks


Joanna: Hello, and welcome to the first edition of GFN News on GFN.TV. GFN.TV is brought to you by the Global Forum on Nicotine from our conference in Warsaw. Year round coverage of the issues that matter in tobacco harm reduction, GFN has got it covered. I'm your host, Joanna Junak. Today on GFN News, the government of the Philippines has approved a key vaporize nicotine product bill. What is FDA doing regarding the regulation of thousands of vaping products in the United States? David Sweanor of the University of OSUA shares his thoughts on doctors and nicotine. Is it true that vaping is a less effective method of quitting smoking than other nicotine replacement aids? And we bring you to the first of our interview series from RegWatch Brent Stafford and his guest GFN 22 keynote speaker, Dr. Mark Tyndall on vaping health and harm reduction. The Philippines is expected to make its evaporate nicotine products regulation below regulating the manufacturer's cells and use of ecigarettes and heated tobacco products. Experts say that it will promote cessation and save lives among the country's 70 million smokers. Yet the Department of Health has condemned what is called the bill blatant disregard to public health. If confirmed, the policy will be a welcome step towards harm reduction for a country that has for years conducted a brutal drug war under President Rodrigo Duterta. Meanwhile, in the United States, much uncertainty remains of the FDA role in regulating vaping products. Let's cross over to Will Godfrey from Filter magazine for an update. Hi, Will.

Will: Hi, Joanna. Great to be here. Yes, over here, all eyes remain on the FDA, as they have been for many months. As you recall, the agency had until September 2021 to determine, under its flexible premarket tobacco product application process, whether every bait product submitted was, quote, appropriate for the protection of public health and could therefore be legally sold. Missing that deadline, the agency has since approved exactly one tobacco flavored vape that very few people use. Together with a couple of cartridges, it remains silent on applications from companies with the largest market share.

Joanna: And what about with smaller companies?

Will: Well, the FDA has meanwhile issued denials for thousands of applications from small to mid sized companies, seemingly using a sweeping one size fits all approach rather than the promised case by case evaluations. As we await decisions on the biggest players, some of those denied companies have been fighting back in court. My Filter colleague Alex Norcia has been regularly covering these situations, so let's now switch to him for some updates.

Alex: One of the main cases to follow here in the United States, if not the main case, is Triton, which filed a lawsuit against the Food and Drug Administration in the Fifth Circuit Court of Appeals. As is the case with most of these denied bait manufacturers, the company's argument partly rests on an internal memo that circulated around the FDA's Center for Tobacco Products. This happened not long after politicians grilled acting commissioner Janet Woodcock about her agency's plans to regulate e-cigarettes and keep them out of the hands of minors. The memo revealed that the FDA, likely in a rush to get through an onslaught of PMTAs, adopted a checklist like method to get through as many applications as possible. The FDA essentially looked for vape manufacturers that make flavored baking products, many of which spent millions of dollars already and rejected their PMTAs. They had not completed scientific trials that many noted were not required only after the application deadline. Triton has dozens of others who filed similar lawsuits and different appeal scores throughout the US. Is arguing that the FDA acted arbitrarily and capriciously through this process. Some companies have been granted judicial stays, which allow them to continue selling their denied products if their cases work their way through the legal system. Oral arguments have begun in a few cases, and while some judges seem sympathetic to the plaintiffs, it's unclear what will happen next. Will Triton's application, for example, be remanded back to the FDA and the company be given time to complete these longterm studies? FDA slogan bureaucracy prevail. The decision ultimately reached the supreme court.

Joanna: Thank you, Alex. Let’s go over to the next topic. The lack of awareness that physicians have around tobacco harm reduction issues is a matter of deep concern to many in our field. Professor David Sweanor recently shared some thoughts about this problem in Canada. Let's listen to him.

David: Doctors are misinformed on our leading cause preventable death, a leading cause of preventable deaths where the solutions are actually not that complicated, but they're being held back because of that misinformation. How do we educate doctors? Simply making them aware that they're misinformed could be a very important first step.

Joanna: Does this only happen in Canada? Will?

Will: No way. Besides being a chronic issue, this is also almost ubiquitous. For example, I recall a 2020 study on which we reported a filter showing that around 80% of US. Physicians held basic misconceptions about nicotine's purported harms, including the belief that it directly causes cancer or heart disease. And colleagues in countries from Nigeria to India have told me of similar misconceptions. As David expressed it's as shocking as it is familiar, and it's a reflection, I think, of how deprioritized nicotine and tobacco are in healthcare, as well as of swirling misinformation in general. I suppose responses to this problem fall into two main baskets: reaching out to physicians and health authorities to educate them on these topics or bypassing them altogether by providing alternative information and resources, such as drop incentives. Colleagues in the UK, for example, and several other countries have told me about current projects to achieve both of these goals.

Joanna: Thank you, well, for your contribution to this episode. See you next time.

Will: Thanks, Joanna. See you again soon.

Joanna: A recent study from the university of California suggests that vapes are less helpful in quitting smoking than traditional smoking cessation AIDS. The research analyzed between 2017 and 2018 found that nearly 60% of recent former smokers who are vaping daddy had resumed smoking by 2019. We spoke to Senior Director of Quality and Science at the American Society of Addiction Medicine, Annie Kleykamp. She thinks the findings may need a second look.

Annie: Yeah, so my reaction to this study is there are several limitations of the findings. A lot of people have talked about the experts that understand population level data. I'm more of a laboratory based researcher, but I would say three primary things that made me question the findings and want to make sure that they're shared with this information with the public. One, the study is a population level study. So you've got data collected through a survey. It's path study. It's very different than a controlled trial. That's important because we have controlled trials showing the e cigarettes can promote cessation, including a Cochrane review, which is collapsing data across trials. And so the fact that that cocker interview, those trials represented in it show the east of promote cessation or are associated with it statistically, and that this study does not show that. That should be something we keep in mind. Why is that? And that sort of goes to the methodology. So there could be many reasons that someone might use an e cigarette, and then you find that they may not be able to stop with it. Maybe they are not using that e cigarette in a way that delivers the nicotine that they need to replace smoking. And we know that a lot of the device types used in this particular sample were older. They weren't the newer generation that might be delivering nicotine more on par with smoking. So, for example, juuls and that's important, that's delivering nicotine in a way that better models smoking is the way nicotine replacement was developed, and you need to be able to deliver that nicotine so a person doesn't go into withdrawal and wants to smoke. Other reasons could be variables or variants that it's just difficult to control for in a population level study. So that's just an inherent challenge to any study where you're surveying people. There may be particular considerations that even statistically, you'll never be able to control for, I would say. The other thing I wanted to point out about this study, my reaction to it is it's very focused on cessation. So the main outcome is, was there any puff from a cigarette in the last twelve months? Any puff? To me, that is an important data point. But for me, I'm also interested, were you able to reduce your smoking at all? Were you able to reduce any of the harm carbon monoxide levels from smoking, maybe because you didn't do a full switch, and maybe you occasionally popped on a cigarette at a party, but compared to the year before, maybe you reduced your smoking by 50%. I think that to me is more important because my understanding of any type of drug that you are trying to replace with another behavior, reducing that dangerous behavior. Smoking in any way is going to improve your health. And so I think that messaging is important. I'm worried the way the study has been shared in the popular press, CNN, it's really been shared as a definitive conclusion to Esaggress are not able to support Cessation and they're no better than placebo. But the same study found that evidencebased, quote unquote, treatments that have been approved by the FDA and other regulatory agencies, like nicotine replacement therapy for a clean, were also not very effective. And this really makes you question what was going on in the study. So if these participants were trying to stop smoking, they used nicotine replacement, something that we recommend all over the world, and they still weren't able to smoke. Most of them, I think it was above 80%. We're not talking about that in the coverage in CNN. And I think this is a really big problem because if you're a smoker and you're reading that study, you may be less inclined to try e-cigarettes. And we know, as shown by the Cochrane Review, among other data, that there are a lot of people that have stopped or reduced their smoking because of ecigarettes. And that's a really important message that's lost in the coverage of this article.

Joanna: Thank you, Annie, for sharing your insights. And now we are pleased to introduce the first of our regular interview series of GFN TV. In partnership with RegWatch. Today, Brent Stafford interviews leading Canadian harm reductionist, Dr. Mark Tyndall, who is set to deliver a keynote speech at GFN 22 in Warsaw. Over to you, Brent.

Brent: Hi, I'm Brent Stafford, and welcome to Reg Watch on GFN.TV. This is the first segment of what will be an ongoing contribution to the important discussion around tobacco harm reduction at global scale. Joining us today is one of our favorite guests, Dr Mark Tyndall, a public health and infectious disease physician who was formerly the director of the BC Center for Disease Control in the province of British Columbia, Canada. And he's been working in the field of harm reduction and drug policy for over 25 years. Dr. Tyndall, thanks for coming back on the show.

Mark: Thanks for asking me, Brent.

Brent: So our conversations here on GFN.TV are intended to reach a global audience and therefore some of our viewers today may not be familiar with you from your past appearances here on RegWatch. Please share a bit about who you are, your work, and why tobacco harm reduction is a special interest.

Mark: Sure. I mean, I kind of fell into this through my other work in harm reduction. And at the time I first got interested, I was working in Ottawa, which was about eight years ago. And my job there was to try and prevent people from getting HIV and hepatitis C who are using injection drugs. And it became clear to me that with the treatments that we had for these infections that I'd spent my career working on, they weren't killing people, it was smoking that was killing people. So the prospective course I was working in, the leading cause of death by far was cigarette smoking. And so I got with the lessons I'd learned from harm reduction, I started getting interested in alternative ways to get nicotine. And vaping was emerging at that time. And I've just been following this and trying to promote this idea now for eight years, probably.

Brent: So you're a doctor, doctor, as we kind of say here on RegWatch, you have patients you treat?

Mark: Yeah, well, that's been my career, mostly infectious diseases, but I'm also researcher. I have a doctoral degree in epidemiology, and so I've done my fair share of research over the years.

Brent: So let me ask you, when it comes to safer nicotine products, specifically nicotine vapes, what's your position?

Mark: Well, everybody should be using them. I mean, I'm very frustrated when I see the lack of movement on this. I think, like many of us, I believe this is the biggest contribution we could make to public health and improving the global health statistics if we could get people off cigarettes. And so I'm an ardent sort of antitobacco person, but I'm also very realistic that this is not going to be solved by banning cigarettes. People use these substances like they use other substances. We have to accept that that abstinence is not an effective way to get people off cigarettes, for the most part. And so people deserve alternatives. And we could make a huge impact if we got people to write information out there and transition people off cigarettes.

Brent: So the big question amazing that I still have to ask it, but are nicotine vape safe?

Mark: Well, the biggest lesson you learn in epidemiology is relative risk. So, I mean, we're stuck with this ridiculous argument that, well, they're not safe, so therefore we shouldn't be promoting them. Well, that just makes absolutely no sense. Relative to cigarettes, they're very safe. And the same kind of ridiculous argument goes that we really don't know how safe they are because we haven't seen them. We don't have the research. Where's the evidence? And man, again, we do have quite a bit of evidence, because tobacco has been so vilified, there's no external evaluation of any of this stuff. All we can measure is how toxic cigarettes are, but there's no money involved in actually doing the proper long term research. But it's just so clear. And again, just try to be practical. We know right down to the molecule what's killing people with cigarettes and all the toxins in a cigarette or combustible tobacco. And to tell me that you take all those chemicals out and it doesn't make any difference, it must be just as dangerous. It just ludicrous to me. It makes absolutely no sense. So really sticking points are that the public has not been told the truth about how relatively safe these products are, and we haven't incentivised people to try it and we're stuck this far down the road. The attitude toward vaping among people who smoke cigarettes is just wrong. Like most people just don't want to hear that they're safer. And that's been a huge misstep in the way we've tried to promote these things.

Brent: Now, obviously are people becoming ill or dying because of this misinformation?

Mark: Yeah, well, there's just so much misopportunity. I mean, because cigarettes and illnesses to do tobacco have been around for so long, we just got so used to it. And any incremental improvement is when we see in Canada that the smoking rates are going down a percentage a year or something, somehow that status quo is accepted as being okay. And it's just not. I mean, we've just got so used to the massive health impact of cigarettes that were just so complacent and how we can still fully support abstinence-based programs, that the only thing we know about them is how ineffective they are, and we need to offer people alternatives and to give them the truth. So I think there's been just a lot of really bad coverage about this and people have not been given the truth. Again, we've been so preoccupied with youth vaping and this whole conspiracy theory that big tobacco is going to try and poison our youth with addictive nicotine products and they're all going to go on to smoking and we're going to start all over again. That just doesn't make any sense at all. It's just so farfetched that I can't believe this has kind of been allowed to be the narrative.

Brent: Why is it that so many within public health believe vaping products are dangerous?

Mark: I don't know. If they do, most people avoid the issue. If you say vaping eliminates all these toxins. I mean, it's pretty much impossible to make a mechanistic argument that vaping causes cardiovascular disease. How it doesn't. But people don't really fixate on that. And I think you've mentioned this in many of your shows. They've kept changing the goal posts that people can't really defend the fact that they are as dangerous, but they now focus on nicotine, and nicotine must be the dangerous thing. And we need to protect our youth and from addicted to nicotine. So that's changing the kind of goalpost of things.

Brent: You mentioned Nicotine, doctor Tyndall, one of the things obviously, that's going on is the gateway. That particular issue never seems to go away. It is Whack Mole. There's no doubt. 1 minute it's teen epidemic, the next minute it's evolved some mysterious vaping related lung illness. When does it end?

Mark: Yeah, no, I mean the gateway thing, I think, has been disproven so many times in Canada at least, we vilified cigarettes so much that it's just not an attractive thing for youth to want to do. And so to think that people would start using nicotine vape and then all of a sudden think that cigarettes would be a good idea. It's preposterous, it would not happen. And unless we try to prohibit access to any vaping products. So that's the downside. But prohibition never works. And the whole Valley story, which set vaping back quite a bit, is basically a story of prohibition. And so we've allowed people started making this stuff up and there was huge consequences to that. So we need a regulated, truthful way to get people access to this. Obviously, they should not be advertised as a lifestyle thing and that we're not there to promote vaping to young people, but we can really should be promoting it heavily to people who smoke cigarettes. And the other irony of all this with our prohibition is that sure, youth will try nicotine. I mean, they'll try a lot of substances and that's kind of why cigarettes have continued. The biggest thing, if we're really interested in youth smoking and youth vaping, then we try to work very hard on adult smokers to switch. Because the biggest reason that youth will take up smoking is because they have their parents or aunts and uncles or other acquaintances who smoke. That's the biggest. So if you really want to help the next generation, you would want to encourage parents who smoke to switch from get off cigarettes. That would be the best way to discourage the next generation of cigarette smokers, for sure. I think that people should have awareness that if they start vaping or start using nicotine because they enjoy the nicotine, there's a price to pay. And that means you're probably going to continue to use that nicotine. I think that it doesn't pose long term danger if you're using nicotine every day. But that's something people have to should be approaching with the eyes wide open. But most smokers I know actually enjoy smoking and they enjoy the nicotine. So I don't know, I think that the irony is when the people that I deal with mostly day to day are people using harder drugs, I don't know where they'd be without nicotine. It's way better to get up in the morning and smoke a cigarette or use a vape than probably to run out and shoot heroin. I think this is all it's a type of harm reduction for a lot of people. And if they weren't smoking, I don't know what else they'd be doing anyways. I'm a hard and fast anti cigarette person. I mean, I really think that cigarettes cause a lot of damage and really unnecessary damage when we have alternatives ways for people to get nicotine. And so there's really no reason that we want to burn burn leaves. I mean, we really need to think of this way more sophisticated, except that people will use substances like they like coffee and coke and alcohol and all the things in our society. This is part of it. Nicotine is one of them. And we want to offer people a regulated, safe way to get it.

Brent: Have you ever been in a position where other public health colleagues that you've been working with have been very pro harm reduction for drugs like heroin? In fact, indeed, in Canada, we are actually giving that out now as a part of the harm Reduction for Drugs program. But yet they're adamant that nicotine harm reduction is not a valid use of the theory.

Mark: My colleagues in public health, definitely I'm still on the outside looking in as far as my attitudes and my promotion of tobacco harm reduction. And these same people will be very supportive of supervised injection sites and other harm reduction things that I've been involved in. And I mean, they've come along like there has been a movement. I think harm reduction 25 or 30 years ago was still in its infancy and there was a lot of concerns about enabling people and encouraging more people to be doing these things if we gave out needles and allowed people to inject in safety and things. But I think that's evolved over time. But my experience is there's still a hard stop with cigarettes because people feel that you should just stop. We all know people who have stopped. Why don't you? Like that's kind of the thinking that we don't need alternatives for people. They should just stop and leave it at that. And I think that's still the attitude. Whereas people who are using heroin and cocaine and these other notorious drugs, people feel, well, maybe they can't stop. Maybe we have to give them a little bit of a road way into stopping. But for tobacco, it's just hard and fast. Like if you smoke cigarettes, you're killing yourself, this stuff. And so I think that's the huge roadblock that people don't really see that for the millions of people who that clearly is not true. They don't really look at it that way. People don't need an alternative. Why would we offer people a nicotine alternative? Like they just don't need nicotine? Well, actually, talk to 5 million Canadians. They differ. They do think they need nicotine.

Brent: So let's talk a minute then about Canada and what's specifically going on in that country. Currently, nicotine vaping is legal in Canada. And of course, Canada has been a world leader in the fight against combustible tobacco. Yet Health Canada is in the process right now of potentially banning flavors. What's your assessment of what Health Canada is doing?

Mark: It makes no sense. I mean, the idea that all the focus is on youth and somehow only youth want flavors, which is totally against everything we know about the vaping industry in Canada, where flavors are a critical component to people trying it and continuing it. And why not? It's just so punitive to me that it should be people's, right? If they have a flavor, like it shouldn't make any difference. But I do fear that it's been kind of quiet the last few months. It's unclear what the final decision, but everything I've heard that probably they'll be a flavor ban or at least leave it open to provinces to make flavor bans and provinces love it. I'm really fearful that that could happen in Canada and it's very damaging to people who are trying to transition. And again, the irony is that Health Canada might say that, well, why don't we give them tobacco? That's what their tobacco flavor? Well, actually one of the ways to get off your cigarettes is to get rid of that tobacco flavor. I mean, we need to give people an alternative to that. So I think it's really be a serious misstep if that happens in Canada. But I think the people that are getting the most attention still are anti youth vaping advocates who still hold to this contention that the only reason that youth are using these vaping is because they like the flavor and it's just not true. But unfortunately, that's the narrative that's persisted.

Brent: I know you'll be speaking at the Global Forum on Nicotine conference in Warsaw, Poland this June 16 to 18. Why is a conference like GFN 22 important? And what might your message be?

Mark: To be honest, Brent, my academic and medical career has not really been in the tobacco area. So this is somewhat new to me. I know of tobacco conferences that are currently held in Canada and some globally that are basically abstinence based. They are out there actively undermining safer nicotine. So that is a forum that most tobacco people have. And I know for a fact I've been disinvited to public health conferences because of my stance on vaping. So a there's very closed door. The Forum, I think, is the only place that I know of that invites the range of opinions and has a wide tent for people to discuss this. But it's hard to find any kind of global or at least Canadian or North American tobacco conferences where you can openly talk about alternatives. It's a very closed shop that the most prominent people in this field have been added for a while. They're abstinence based and they're not even open to discussing this. And instead of seeing alternatives as a way to improve people's health or give people other options, they look at it as a side door for more nicotine addiction and more tobacco use and are totally dismissive of any benefits that people can gain from vaping.

Brent: Last issue, Doctor Tyndall, are there any potential allies in this battle that we should be thinking about and working with?

Mark: If we're serious about making a massive transition and actually eliminating cigarette smoking in some kind of time frame, we need to get on board with companies who make cigarettes and are very open, I think, to coming up with alternatives. So they probably do want to salvage their money. They're a company that probably aren't interested in just shutting down cigarettes, but they are probably very interested in coming up with safer alternatives. And so I think we need to help guide the tobacco companies who are still manufacturing cigarettes. If you go to the website of Philip Morris International, I mean, they make it quite a statement that they want to get out of the cigarette business by 2035. I think it's much like we do with climate change and trying to get into the oil and gas industry and help them transition. And they probably are open to it. But if we're just nothing but hostility and we just set ourselves up as cigarettes are bad, the companies that produce them are bad, we want to wipe them out, it's going to be a long, long haul. It's just not going to happen anytime soon. And it's just so unnecessary because the companies themselves will do all the heavy lifting. It wouldn't even be a big expense for governments. They don't need to recreate this thing. The technology exists. The companies will transition. They need to be incentivized to transition, for sure. But I think that's the only way that we're going to see in the next decade, cigarettes go away in Canada if we embrace kind of the new technology that can be offered through existing companies who make cigarettes. So I think that's the only practical way forward.

Brent: Allowing safer nicotine products to be a path of redemption for big tobacco.

Mark: Yeah, well, I think they can they're motivated by money, but the problem is, unless they're incentivized some of these big advocacy pieces like flavors and taxes and things, as long as they have a steady stream of cigarette sales, their motivation to really go after these policies are a bit stunted. If it happens, it happens. If it doesn't, then we're selling a lot of cigarettes and we're making a lot of money. So I do think that they really need to be pushed and guided and incentivized and cajoled. And so I think they can be moved in that direction. But it's going to be a slow process if all they get is a backlash from governments and government policies, and they're not going to go way out on the limb and jeopardize their cigarette sales. So they're going to try and play by the rules. And so we really need still strong advocacy to get them pushing harder, basically to make these changes.

Joanna: Thank you, Brent and Mark, for a great discussion. We look forward to seeing you both in Warsaw this summer. Thanks for watching and see you next time for more tobacco harm reduction updates and Brent for coming interview with Dr. John Oyston. Book your place for GFN in June in Warsaw and find out how to submit a GFN Five at our website, That brings us to the end of the first edition of GFN, goodbye for now.