0:00 - Intro
0:40 - Mexico banned the sale of electronic cigarettes and other vaping devices
14:38 - FDA has ordered the vape company Juul to take its products off the market
17:07 - Brent Stafford of Regwatch interviews Paddy Costall
37:58 - Closing remarks
Hello and welcome, this is GFN News on GFN.TV. I’m your host Joanna Junak. In today’s news:
A ban on vaping devices in Mexico has been announced. We will hear reaction from Tomas O’Gorman and Roberto Sussman
In the United States, the FDA has ordered the vape company Juul to take its products off the market. We’ll be asking Will Godfrey for his thoughts.
And after the news, Brent Stafford of RegWatch interviews Paddy Costall, co-founder of the Global Forum on Nicotine.
At the end of May, Mexico banned the sale of electronic cigarettes and other vaping devices. In the last episode, Will Godfrey shared his thoughts.. Today, we’re speaking to two experts from Mexico about the situation there. Tomas O’Gorman is a lawyer, ex-smoker and vaper since 2016, as well as co-founder of "Pro-Vapeo Mexico" and a member of INNCO’s Board.
Joanna: Hi Tomas, can you tell us why the government decided to ban the marketing and sale of vaping products?
Tomas: I don't know. I guess the government is following the Union’s script like if it was a movie. If you remember, the Union issued some kind of positioning regarding safer alternatives in LMIC in 2020 called When Bans are Best, suggesting that all LMIC should ban these products and cancelling therefore the right of people to access harm reduction products. Why do I say this? Because in February of 2020 the government, our President, issued a decree banning or prohibiting the import of vaping products. This decree has been ratified in several decreases, around three more decrease after the first one. And now it has been introduced into the law that regulates the imports and export taxes. And now we find that on World No Tobacco Day, the President received some kind of award from WHO and curiously he produces, he signed the degree and now he has banned all forms of commercialization and transit of these products within the country, the whole country. Transit does not mean being in possession of making products. We can use them and we can have them in our possession, but we cannot buy them. Why? Because there are no sellers. At least that's what the decrease says. I think this reflects that this government has in some way cancelled any possibility to consider harm reduction as an option for smokers and for people who want for the reason they made him approve it. Consuming nicotine. It is a very authoritarian measure, I think, especially if you consider that in October of last year, like in October, the Supreme Court of justice of Mexico ruled that the existing ban of commercialization in our law, because, to be fair, commercialization of vaping products has been banned in Mexico since at least 2010. Not because it was an express prohibition, I mean, it was because in our law there was a provision very similar to the one in Western Australia. And the court ruled that the total prohibition of commercializing these products was unconstitutional. So it is amazing that considering that judicial precedent, the president with this decree is doing exactly what the court said. It wasn't constitutional, again by this decree, making this ban. Right.
Joanna: What are your personal thoughts regarding the ban?
Tomas: I think it is really sad. I was a two pack a day smoker six years ago and I quit, particularly in an accidental way, because I didn't want to quit smoking when I start vaping. And because of that, that's why I started trying to do some kind of advocacy for safer alternatives because I want Texas smokers to have the same opportunity I have. And this is becoming almost impossible. And it is sad to see how our rights are being denied, are being breached, are being cancelled, because it is not only the right to help and it is the right to autonomy, to decide to consume nicotine in a safer way with a safer alternative. And it's sad to see this kind of autocratic decisions cancelling almost all possibilities to make harm reductions right. And for smokers, they will continue smoking because they are not banning cigarettes. So it is absurd. Especially Mexico is an LMIC and I think that harm reduction and the access to safer alternatives would benefit the most in LMICs. Not only because most part of the smokers in the world are living in LMICs, but because smokers in these countries don't have access to other quitting methods, at least they are not easily provided by countries, by governments and our healthcare systems. They are not very good. And access to good healthcare assistance is not a reality. So it would be in the best interest of any government to lower the diseases related to smoking. And safer alternatives are one very good way to be able to end with all these diseases. Right.
Joanna: What will be the consequences of this change?
Tomas: The consequences? Well, the government has been writing, making some sighting, merchants and closing stores in the last few days. What will happen? Stores will go into the dark, I guess they will still working. We will have thriving black market with all the bad consequences that arise from this kind of markets, problems with quality and safety of the products, maybe even things related to crime. Mexico has a very serious problem regarding drugs and drugs cartels. And maybe I'm being exaggerated, I hope not. But I fear that all these gangs and all these crime organizations will see vaping, a new way of earning money. Because there is a market for this product in Mexico. My best guess is that at least we have 1.5 million adults using these products, maybe two. So the black market will drive with all the bad consequences. It will be far more difficult for users to access alternatives. And on the other hand, we might be subject to some kind of stigma of using a product that the government is saying it's very dangerous, or more dangerous actually, like tobacco. Because two weeks before the decree, the government launched some kind of maximum sanitary alert warning the population that the use of these products was terrible and it was a health problem. If they don't do that with other products like alcohol and tobacco, the effect is that I guess people will think that vaping is far more dangerous than smoking, right? And the problem with that decree that it's absolutely anachronic because it is mostly based on the value considerations and the using of vitamin E as an ingredient of vaping products without distinguishing liquids with THC, which were the products that were deliberated in the States in 2019 and in 2022. The government of Mexico is using that problem that happened in the past, almost three years ago, as a way to inform people about the risk of the products and without differentiating THC vaping, if it can be called like that, and real vaping or conventional vaping, which is vaping as an alternative to tobacco.
Joanna: Thank you, Tomas. Let’s see what Roberto Sussman thinks about this ban. Roberto is the founder and Director of Pro-Vapeo Mexico, an association representing Mexican consumers of non-combustible nicotine products and is a member of INNCO. He is also actively advocating for an appropriate regulation of Tobacco Harm Reduction products in Mexico.
Roberto: It is a very counterproductive measure. It's a very authoritarian decree and very authoritarian policy. It was not consulted with anybody. It was imposed in a vertical way, and it is completely dismissive of the consequences because it is a measure that will trim in our lives more. It will trim in our lives even more. One and a half million users, people who use the devices either smokers who want to quit smoking or want to migrate to a lesser harm, deliver lesser harm, or people who just try it. It's a product, so there's going to be people who try it. And also it deprives 15 million smokers who are still smoking with the option, a legal option, together with information about these devices. Because once you buy it, then the only information is information given by the Health Ministry, which is based on lies. I'm not meaning words. It's lies for our health minister, the de facto Health Minister via crisis never ended. So he warns that the devices are legal, and his argument is based on the crisis. In fact, he mentioned specifically that the devices contain acetate of vitamin E, which was the cause of the crisis. But he doesn't mention that that crisis came because of a black market. And he's opening the door to the black market. And it is very worrying because there are already signals that criminal elements are entering to supply this market. Because we have seen lately a flood, really a flood. They are everywhere. Or very cheap disposable made in China, and they are very low quality. And this is a very extended distribution network. They're everywhere. They are being sold by street vendors. They are in commercial classes, they're in corners in street market. The informal, the traditional vendors acting in an informal market, they are not criminals. There are small merchants, small vendors, and they don't have the resources to put up such a large distribution. So who is doing that? We don't know. But it is a sign that criminal organized crime in possible association or tolerance by the government is doing this. So we do have what the Americans call the alliance between the Baptist and the bootlegger, right? So it's very disturbing.
Joanna: Let’s turn now to the United States, where the big news has been the FDA’s June 23 denial of Juul’s marketing applications under the PMTA process. Hi Will, can you tell us more?
Will: The decision has shocked most people I know in the THR community, Joanna. As we've previously discussed, the FDA has already rejected large numbers of applications from smaller companies to be authorized as appropriate for the protection of public health under the PMTA process. But a handful of vape products made by large companies with the resources to include reams of scientific information in their applications have been authorized. Many believe that Juul would join them. And Juul, of course, is quite simply the biggest name in US vaping. After coming on the market in 2015, it was embroiled in controversy for ads deemed to appeal to youth, inspiring sensationalized media coverage of a supposed youth vaping epidemic. Youth vaping has more recently declined, and most youth who do vape prefer other products. And Juul, which I should disclose, has contributed grants to my own organization, has in recent years demonstrated excessive caution pre-emptively pulling its slavers from the market in 2019, for example, before the law required it, the company no longer has the market dominance it once did, but has remained a huge player in providing harm reduction options. As Clive Bates put it, it was the most successful anti-smoking product ever seen, and the FDA's decision is to try to kill it.
Joanna: Why do you think this happened? And what happens next?
Will: Well, the FDA claimed that Juul’s applications lacked sufficient evidence regarding the toxicological profile of the products, which seems questionable when any such deficiencies could have been addressed earlier in the process. Many observers view it rather as political punishment for Juul's perceived past sins. Juul, for its part, has said that it respectfully disagrees with the decision and will seek a stay in the courts. A major legal case seems inevitable. Some smaller companies have had success with lawsuits against the FDA, and Juul should certainly have the resources to fight such a case. But as things stand, millions of people face losing their preferred alternative to cigarettes in a disaster for public health.
Joanna: Thank you, Will. And now, we go over to Brent Stafford and his guest, Paddy Costall, co-founder of the Global Forum on Nicotine. In today’s interview, Paddy shares his views about the future of tobacco harm reduction, which was the subject of the ninth Global Forum on Nicotine this year in June in Warsaw. Over to you, Brent.
Brent: Hi, I'm Brent Stafford and welcome to another edition of RegWatch on GFN TV. We're here in Warsaw, Poland for the Global Forum on Nicotine FM 22, and I'm sitting here with a Pentecostal, the conference director.
Brent: Now, you've obviously been a part of this since day one. Why nicotine? Why is there this the ninth year of a conference that's all about nicotine?
Paddy: I think everybody involved in the early days and everybody's still involved from the from our team most came from a drugs. Background working with drug users, working with people who problem drinkers, whatever, people who don't fit within the norms of society. And I think one of the things that people fail to recognize is that we expand an awful lot of effort, time and effort in mitigating the harms caused by different drugs. But the one elephant in the room that people were not addressing was smoking. And there were far more of the people that we worked with who were going to die from a smoking related disease than we're ever going to die from overdose or any other drug related disease. And to actually try and assist people through difficulties and not attempt to deal with one of the most dangerous the dangerous behaviours that they would exhibit, just seem to me and others to be a bit nonsensical. We started to talk a little bit about harm reduction with alcohol, for example. How do you make drinking spaces safer? People being trained to know the signs when there's a problem. The playbook was well established in terms of tobacco harm reduction for drugs, and largely that came about as a result of the response to the AIDS pandemic, where, you know, there were measures that were taken which would be wholly unacceptable 20, 30 years ago, which was giving people clean needles, giving people substitute, prescribing that various other things. But tobacco had never, never really been tackled. And then, you know, 15 years ago, the emergence of these new single out products and people taking nicotine and a cleaner and safer way. And in parallel to that and in tandem with it, you have the growing body of evidence and research that was emerging saying these could be effective ways of helping people quit. And the language that we were using them was the language of tobacco control, which was quitting, stopping, smoking, all of all of the kind of negative reinforcement. And then what we started to do was change that slightly, changed the lexicon slightly. And we started talking about switching. Now, there is some people might say that's semantics, but it's not because stopping is you or you set yourself a date and you're going to quit doing something completely. But people say, I enjoy smoking. Most people who say that say it because they enjoy nicotine. I don't necessarily think they enjoy the feeling of smoking. So some people say, well, I don't want to stop using nicotine, but I don't want to smoke. So tobacco harm reduction is a strategy which basically enables people to have a way out, but to continue to enjoy what they've enjoyed for years. The other thing that's become a bone of contention has been regulation, and regulation has been used as a blunt instrument by tobacco control and by W.H.O. and others to stop people doing things. It's kind of if we tack. It, or if we make it impossible to use or we make it illegal to use in a particular place that will stop people doing it. Well, I'm sorry news for you here and that this is not going to work.
Brent: In the ten years, almost ten years since you started this, did you think that the state of the acceptance of nicotine and delivery devices like e-cigarettes and then their snus and know products and so forth, could you have imagined that things would be this dire?
Paddy: Myself and my colleagues, particularly Gerry Stimson, whose history in the field of drug use, etc., the drug and HIV eminent international research and public health scientist. Naively, we thought the people would embrace this and welcome it with open arms. Oh, my God. This is something that we can really get into. And we've been gradually, as over the years, we've been ostracized. He has particularly. And the one the one group of people that is absent from the conference and who need to be in the room to have the discussion properly, are the are the scientists, the public health scientists? And the reason for that is that they are, in many cases, fearful of being seen to be too cosy and too close to people who were considered to be an extension, a shill of the tobacco industry. I found that quite offensive, to be honest. What we have always said is that the Global Forum is the only place where science and policy can meet. And we don't exclude anybody. We do not practice any kind of prohibition on people coming.
Brent: Now there's certainly been a growing movement. It's not receding, it's growing. And that's kind of an academic apartheid, if you can put it.
Paddy: And we I mean, we have sessions in this conference where people are going to tell those stories about how they have been progressively marginalized by their colleagues, people who are eminent and well regarded, international researchers in a very, very new and exciting field. But they've gone off message and they've started to say, Hey, there's something in this. We've got to talk to these guys. And I think that that's a sad, sad situation. I don't know how we can resolve that, but all I can say to anybody in tobacco research, tobacco control is the door is open. No one's going to stop you walking through it. Nobody's going to be nasty to you. What we want to do is have the discussion talk. Let's explore where the differences lie and let's explore where the similarities lie. Because as somebody pointed out to me a long time ago, tobacco harm reduction is part of tobacco control because you have to you have to use, again, all the tools at your disposal. Nobody disputes the tobacco burning. Tobacco smoking is a very, very deadly habit. It's a deadly it's a deadly behaviour. And nobody disputes that. It would be a great idea if we could end that, but we can't end up by just getting rid of tobacco. It's there. Many, many economies in the world depend on tobacco. There's a lot more it's a lot more complex argument than a simple, you know, if tobacco companies were serious about changing into new products, they'd stop selling cigarettes tomorrow. I don't think you could do that.
Brent: And in many places in the West, to put a point on it, there's often messaging that comes out that actually says that say vaping is as dangerous as smoking. Certainly the public believes that. And that's a huge change in just the last five years. And that that's coming from public health.
Paddy: It's a lie. It's as simple as that. It's wrong, manifestly wrong. And what we've what we've actually moved away from is scientific analysis. And we've moved into ideology and sloganeering. And it suits a large section of the media, because the media likes simple messages and it likes to be able to portray things simply. You do not get the kind of editorial content in mainstream media that you used to get. You don't get both sides of the argument being put. You get much more of a sort of visceral or emotional response.
Paddy: people who use nicotine may be dependent, but they're not going to go out burgling people's houses to get their nicotine. They're not you know, it's not crack cocaine. It's kind of it needs to be viewed as something that in the same way as some people are dependent on caffeine, you know, oh, I can't start the day without my first cup of coffee. That's exactly the same thing. But none of those people would actually call themselves addicts. None of those people would want to be described as an out there because an addict is a certain construct. It's a shabby, dishevelled person sitting in the gutter, either drinking from a bottle or injecting themselves with other substances. And I think that's another thing. It's because it's one of the things that's used by the ants. When they one day attack, they say, oh, nicotine people get addicted. Well, they don't. People, as I say, can become dependent. I think dependence is a very much more benign concept than addiction. I mean, worked in the field of drug use and drug abuse and alcohol and various other things. I can honestly say that I've never I've never been able to see any of those characteristics in people who either smoke or vape or use snus or use patches, gums, whatever it is they do.
Brent: So you use the term ants. What exactly is that?
Paddy: People who are anti-Tobacco Harm Reduction, there are people who increasingly, as the science mounts up on our side of the argument that tobacco harm reduction is, is has efficacy and it's actually something that benefits a lot of people and keeps people alive. They get increasingly desperate and they are launching attacks on people for all sorts of reasons. And I mean, to use the football analogy, they're playing the man, not the ball. You know, they've given up on trying to attack the science and discredit the science because the science is coming out strongly saying that nicotine is manifestly less harmful than smoking. They're using vaping products or using heat, not burn products. I mean, everybody now is familiar. I think with the cliff of risk, the tobacco problem is you have something that you set fire to and then you have things in descending order. But rather than descending in a gentle curve, they descend like that. And then they then they decrease more rapidly as or less rapidly as you look along the spectrum of what people use. So I think that we need we need to have an honest debate and an honest and an honest discussion. And that's what this event is about.
Paddy: There's the other myth that, you know, people are getting hooked on vaping. And then switching to cigarettes. Marginal minor? No. No real evidence of it at all. Personal view. I'm not a scientist, but kids experiment and some kids will stay using these things. And most kids will say, what's next? What's my what's mine? What's my next experimentation? And even if even if young people dare I say it, and I know it's heresy to some people to say, but that I say that if they continue survive, it really isn't that big a problem. Parents should be much more concerned about other things that are much more dangerous, like smoking. And I'm not saying that we should encourage people to be able to use other forms of nicotine, but I think we should accept it as a reality and not get to emotive and to panicked by the whole thing.
Brent: And certainly, I mean, there's the what is it, the common liability theory, which says that some of these kids who may have tried in e-cigarette first, who may have then gone on to smoke, would have more likely have been trying smoking anyhow.
Paddy: Yes. Yes. Yeah, I think that's true. And I think that I was talking to somebody yesterday and disturbing thing she was saying is that her child goes to school and teachers in the school are telling them, given the public health message about the dangers of vaping, you know, it's how really, really bad and how dangerous it is. And she said it was she was quite proud of her son because he stood up and said, that's wrong. And, you know, my mom is a vapor and she works as a researcher. And the teacher had no answer and it was just sit down and be quiet. But they are being I don't envy teachers position because they're being given the task of moulding people's beliefs and one thing and another. And that is the kind of messaging that's coming out. And this is coming from groups of parents and others who were being co-opted into this whole kind of nicotine is evil and it's a big plot by the tobacco industry to get all our kids hooked. It's not
Brent: It always seems to be about control, and when it comes to the kids, it seems to me that maybe nicotine has gotten in their way of a grand plan to re-engineer kids to be better people.
Paddy: I personally I mean, I don't have children, but my view is that parents need the best information possible for them to make decisions about what they do with their child, because their responsibility is to ensure that our child is safe, well and able to function in society and can grow. And I think that if people have an aversion to people vaping, smoking or whatever, they're quite within their rights to hold those views and to do whatever they see as fit. But they should be doing that from a position of knowledge, not prejudice. And what we've got now is we've got we've got a campaign that is relentless in trying to frighten people into the belief that they need to be very wary of something which the evidence doesn't suggests merits that. And I think that that's a very, very dangerous trend. You know, it's a slippery slope.
Paddy: As I say, all we want to have is a sensible, open and honest conversation and, you know, no hidden agendas. But we can't have that because they won't sit in the room with us.
Brent: The motto for this year is tobacco harm reduction here for good? What does that mean to you?
Paddy: It means two things. It's here because it's good and it's not going away any time soon. So interpret in whichever way you wish. But what we're doing, I think, is we're putting a marker down and saying we're moving into the next stage of the game. Now, where we proved I mean, you know, all of the sort of, you know, all of the strap lines from the various conferences that we've had. And we moved in the direction of we're building we're building the evidence, we're building the case for tobacco harm reduction. And now what we're saying is we're not going away. You know, we're not going to say, well, that's the job done. Let's move on and start looking at something else, because we're not what we're trying to do is we're trying to build alliances and establish working relationships with people in fields where the vast majority of the clientele are smokers and the obvious ones being drug use, alcohol use, mental health issues where, you know, the stats don't lie. And in total, 80, 90% of the people are smokers. And how can we work together to help them to determine a strategy that's going to it's going to change that.
Brent: Let me ask you this, Paddy. We've been covering on RegWatch over the last well, I'd really say the last year, but it's been very noticeable in 2022 that there really is an uptick on the amount of research that's been coming out that has been positive towards vaping evidence based. There's a real movement that seems to be happening within tobacco control research on those that are or that are doing it. Am I seeing something there that's not there?
Paddy: No, I think I mean, it was one of the things one of the highlights in our first global state report, global state of Tobacco Harm Reduction report, when Harry Shapiro was researching for that, one of the things he looked. It was like and I think it was 2005, there was something like 17 or 18 publications that he could find that were directly related to kind of nicotine and tobacco harm reduction. And by the time the first report was issued, which was 2018, there was something over seven and a half thousand papers had been produced. So it's an area of growth and it's a massive area of growth. The problem is, of course, that research is commissioned by people with an agenda, I would say, and that's unfortunate because it's kind of, well, how much will it cost you to find this for me? I need it. I need this outcome. How much is it? You know what research you need to do to find out rather than what you think will happen if we do this. And that's what we want. We want open minded researchers who will employ their talents and their skills to actually not support one side or the other of the argument. And that's what's necessary.
Brent: In the US come July 15th, the you know, the new regulations on synthetic nicotine hit pretty much every product that's on the market except for a couple of these products that have received FDA approval. But pretty much the entire business goes into gray market, black market. What's going to happen to the millions of people who use the products?
Paddy: I think there will be a slide back into people start smoking again because availability and accessibility are two of the big the key issues. I think the regulators regularly shoot themselves in the foot because regulations should be about safety and basically making sure people aren't getting ripped off. It should not be about, let's put the price up, let's make them inaccessible, because what you create there is you create the black market. I think it's a shocking situation and a lot of people will suffer. But the other thing I know from knowing lots of consumers [00:34:00] from all around the world and here today, the 60 or 70 from probably 30 or 40 countries, they're resilient. They will find a way because what they found is they found a life affirming and life changing product that helps them get through the day and doesn't harm them. So they're not going to give it up.
Joanna: Thank you Brent. That’s all for today. Thanks for watching and see you next time, for more tobacco harm reduction updates and Brent’s forthcoming interviews with more Global Forum on Nicotine panellists. Thank you and goodbye.