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Chapters:

0:00 - Intro

0:58 - The US Food and Drug Administration receives new powers to regulate synthetic nicotine

4:14 - In Australia, the state of New South Wales has launched a Campaign to stop young people vaping

6:25 - More tobacco harm reduction experts say that smoke-free products will help the Philippines reduce their smoking rate

8:53 - Brent Stafford of RegWatch interviews Nancy Loucas

30:58 - Closing remarks


Transcription:

00:13

Hello and welcome to GFN news on GFN TV. I'm your host, Joanna UNAC. In today's news, the US Food and drug administration receives new powers to regulate synthetic. We will hear more from walgartfield of realtime magazine in Australia, the state of new south Wales has launched a campaign to stop young people vaping. Dr. Connie mendelsohn shared his thoughts. More to borrowham reduction experts say that smokefree products will help the Philippines reduce their smoking rate. We will hear more from one of them. And after the news, brent Stafford of record interviews nancy Lucas, executive coordinator of kafka and GFN. Fred Kenad, speaker. On 15 March 2022, us. President Joe biden signed into law a spending bill that gives the food and drug administration authority over synthetic nicotine. The bill amends the definition of the term tobacco product as any product made or derived from tobacco or containing nicotine from any source that is intended for human consumption. The law will go into effect in 30 days. Let's cross over to will godfield from filter magazine. Hi, will. Hi, Joanna. Tell us, what does the same bill mean for american consumers? Frankly, no one is sure at this point, though it looks ominous. The new law is a result of increasing political focus on things synthetic nicotine, which we've also seen with the introduction of state level bills that would effectively ban it. Synthetic nicotine has been seen as a legal gray area because the FDA's remit only covered tobacco derived nicotine, and that has allowed continued sale of the flavored synthetic products on which many former smokers rely. But I suppose it was inevitable that this unregulated environment wouldn't last. Now, companies that sell synthetic products will have to submit premarket tobacco product applications to the FDA, just like other baked companies did. And it hasn't gone well the first time around. So far, there have been a couple of belated authorizations of some little used tobacco flavored products made by tobacco companies, most recently japan tobacco's logic brand. Meanwhile, reams of marketing denial orders have been issued for flavored products and those made by smaller companies. Some of those are now being contested in court. The new PMTAs for synthetic products will have to be submitted within 30 days after the law takes effect in mid April, and that seems an impossible ask, given the longterm studies required. The FDA will have 60 further days to decide whether products with pending PMTAs can stay on the market. And what happens if the FDA does not make its decision on time? Based on past performance, it seems certain that the FDA won't issue authorizations in anything like that time frame. As we speak, even heavily resourced applications from the likes of juul are still pending more than six months after the last deadline passed. It boils down to whether the FDA will issue loads more marketing denials right off the bat, or whether the agency will exercise its enforcement discretion to take synthetic products off the market while applications are pending. Either scenario would mean the rapid removal of options for former smokers. The last question was where do Puff bar products come into this? Well, puff bar has become the latest bet noir for the anti vaping lobby. Its disposables seem to have grown in popularity among youth in the context of an overall steep decline in youth vaping, and that has been used to ramp up the pressure on synthetic in general. Like many others, the company switched to synthetic originally in order to continue operating after its initial PMTAs were denied to stay in the business. It'll now have to submit new PMTAs like all the rest. Thank you, Will. See you next time. The Australian state of New South Wales has lamped a campaign. Do you know what you're vaping? To persuade young people to stop vaping. The campaign is aimed at secondary school students and states that vaping is not safe and can have harmful longterm effects of the physical, health and brain development of young people. Minister for Health and Medical Research for New South Wales Brad Hazard has said that research has proven that ecigarettes are just as addictive and harmful as regular cigarettes. Dr. Colin Mendelsohn is a tobacco treatment clinician, founding chairman of the Australian Tobacco Harm Reduction Association and author of a new book, stop Smoking, start Vaping. We asked him why he feels the campaign is providing Australians with many misleading and inaccurate messages. The New South Wales state government has recently launched a campaign to reduce used vaping. Unfortunately, it's full of alarmist and misleading information and is bound to be a flop. The campaign material claims that vaping is linked to serious lung disease, and we know that's not true. It makes false claims about nicotine and exaggerates the risk of the low doses of chemicals in vapor youth. Vaping in Australia has been turbocharged by the de facto ban on nicotine, which has led to a thriving black market which sells unregulated and mislabelled products freely to youth. And providing emotional and alarmist information to young people isn't going to help. So the solution is to comprehensively regulate nicotine vapes so they're safe and available for adult smokers who can't quit from licensed outlets and to enforce restricted access to young people. And that's something we should be able to do. And if we do it properly, the black market should diminish and the sales for kids will also decline. More tobacco harm reduction advocates are in agreement that Philippines should provide smokers with less harmful alternatives to cigarettes. They argue that different studies confirm that vaping is much less dangerous than smoking. Meanwhile, the Department of Education appeared to President Roberto Duterte to visit a vape bill, saying that if passed into law, the bill allows young people to legally get the harmful products. Let's hear again from Dr. Colin Mendelsohn as he explains why signing the bill would be so important for Filipinos and what would happen if President Duterta did not sign the bill. The bill to legalize the sale of less harmful alternatives to smoking in the Philippines is a huge opportunity to improve the health of the 16 million Filipino smokers. Smokers should try to quit if they can. But if they can't, switching to safer nicotine alternatives can dramatically reduce their exposure to the toxins in smoke and lead to substantial health improvements. These products include vaping and heated tobacco products, which can provide the nicotine that smokers need, as well as the smoking ritual which will take and replace. Most of the harm from smoking comes from burning tobacco, and none of these products actually burn tobacco. There's no combustion and no smoke, although they contain nicotine. We know nicotine is relatively harmless, although it is addictive. And in countries where they're being legalized and they're readily available, we've seen dramatic reductions in smoking rates such as in the UK, New Zealand and the US. And the national smoking rates have fallen. The fall has been accelerated in the national smoking rates in those countries. Now, these products are not risk free and they're not for young people or non smokers. But for smokers, they can lead to dramatic health improvements. And when the President signs the bill for this legislation to bring it into law, it will prevent many deaths in the Philippines and a considerable amount of smokingrelated disease. Thank you, Colin, for sharing your insights. And now we go over to Brent Stafford and his guest, executive coordinator of Kathryn, Nancy Lucas. In June, Nancy is set to deliver the Fred keynote speed at GFN 22 in Warsaw. Nancy's Talk is titled Community Regional Networks in Consumer Tobacco Harm Reduction Advocacy. In today's interview, however, Nancy will share her thoughts on how Azure Pacific advocates fight for safer nicotine over to your brand. Hi, I'm Brent Stafford, and welcome to Reg Watch on GFN TV. This segment is our contribution to the worldwide discussion about tobacco harm reduction and safer nicotine products. Joining us today to discuss THR advocacy in Asia is Nancy Lucas from the Coalition of Asia Pacific Tobacco Harm Reduction Advocates, or Capra Advocates on behalf of adult safer nicotine consumers for the right to access and use tobacco harm reduction products in their region. Nancy, thanks for joining us today on Red Lodge. Thanks for having me, Brent. Much obliged. So first off, tell our viewers about Kafka. How did it start, what regions does it operate and what's its purpose? Okay, Kafra is a coalition, a voluntary coalition of consumer THR advocacy organizations in the Asia Pacific region. So it includes Asia as well as Oceania, including Australia and New Zealand. That being said, we advocate for the entire area, the entire region, whether we have a consumer group or not. The purpose of Casa is support and collaboration. Everything that goes on in the region is interconnected. There is a lot of influences across borders with terms of policy, cultural context. So that is the main reason we do what we do because we were finding that a lot of things that were happening outside of the region didn't translate very well into policy in the region. So how does the battle, the kind of fight, affect each of the different countries and how do you work together? Even though we are under a similar framework, we all have individual differences within our countries. Asia is interesting because Asia is home to the majority of the smokers in the world. Okay? The global, we've got it, it's not a prize, but we are the ones that have the majority of the smokers. We are also the region that has the majority of government interests in tobacco. So as I'm sure you can imagine, it creates quite a bit of dissension and a little bit of cognitive dissonance when it comes to public health policy because our governments are heavily invested in working with the who, and yet at the same time, a lot of them are very heavily invested in tobacco manufacturing production. So it's an interesting way of looking at things, let's put it that way that other people can't quite understand. Top line for us, the battle in Asia historically, and we speak a lot about vaping products and nicotine vaping products, and I know that there's a lot more than just that. But assuming vaping are they proving generally in Asia, anti vaping, how does that work? Because of the influence of the government and tobacco and the manufacturing and development, they tend to be very anti vaping as well as their involvement with who. However, that being said, a lot of the reason outside of the WH that there is very strong anti THR sentiment is that there is a lot of meddling in public policy coming from foreign actors from overseas. It was made very clear with what happened in the Philippines with the FDA there accepting funding from a Bloomberg funded organization, which of course works in their favor because now they're looking towards having a legalized regulated market in the Philippines. So, like I said, it's not as simple as everyone thinks it is because there are many different bad actors that are involved that we're up against. So you have an excellent promo video that's on the Advocates Voice, where you take on the who and it's recent report on Ecigarettes. Let's just have a quick listen. Hello everyone and congratulations to who on the new Empower report. The who released their report on the global tobacco epidemic. New products like flavored Ecigarettes pose major threats, especially to young people. Tobacco companies are promoting them as safe alternatives to cigarettes and other tobacco products. It's another dangerous chapter in the industry's history of deception. A report based on biased evidence and bad science to evoke a moral panic. Exposure to nicotine from e cigarette vapor does in fact cause lung cancer and end up on life support because of it. Research also shows that kids who are vaping are four times more likely to then turn to combustible cigarettes. The organization that is charged with looking after our health continues to ramp up its efforts to destroy the one version of harm reduction that has potential to reduce illness and save lives. They are condemning millions of smokers to certain death by denying them the right to safer alternatives. That is an excellent video. What was the response? Well, people on the pro THR side thought it was rather confronting that we'd actually address it, but it needed to be addressed. There was no response from the other side that I'm aware of, but who knows? It's not like they talk to us on the regular and let us know what they're thinking. But, yeah, it went over pretty well. We needed to do it. It was the brainchild, actually, of the video editor that we work with who also happens to be my partner. He's like, we need to get a little angry here, and we need to kind of call them out. I'm like, okay, go for it. And that's what we got. It seems to me, Nancy, that the kind of battle that you're fighting there in Asia is exactly the same battle that's being fought over here. It is and it isn't. Yes, in many ways it is very similar, but in other ways, because of the other aspects, including the government tobacco interests, including cultural considerations, for example. I think all of us around the world are fighting the same battle, but we're doing it on different fields in different arenas. Okay. And we need to understand that there are slight differences across that. But mainly, yeah, we're all fighting at the same battle. Absolutely. Some of the tried and true pieces of misinformation and tactics that have been used by anti vaping opponents over time here in North America get retried retreaded out in the other markets, such as the Asia market. Is that the case? Yes, absolutely. And there's a reason for that. One of the bigger reasons for that is that there aren't as many experts, tobacco harm reduction experts in Asia. There are a few, and also the ones that are prothr tend to stay on the down low simply because of the way the government's operate here. If you work for the government, you can't speak out against the government, so you can't publicly come out and say, hey, listen, this is a good thing. It won't work. So, yes, they do listen to overseas experts and also some and most, I would say now, of the public health experts in Asia were trained overseas. So therefore that's their point of reference. How involved has Bloomberg and advocacy organizations been in Asia? Quite. I think the FDA situation in the Philippines was just the tip of the iceberg. We know that there have been infiltrations, let's just say, into Pakistan, into Thailand, and into Malaysia, but not as much. But the Philippines was nearly the tip of the iceberg. And again, these people operate on the down low. So I'm sure there's plenty of stuff going on that we don't know about. So for our viewers that might not be familiar with what happened in the Philippines, walk us through that. Okay, first of all, in the Philippines, president Duterte has always been very anti smoking and anti vaping. He is not somebody you want to mess with. Okay? And what happened was that the union, I believe it was the union went in and courted their FDA, which is the same as the one in the states, it's the FDA and courted them and provided them with funding and assistance to write the regulations on nicotine and vaping products. And obviously, that was going to be very restrictive and requesting bans and so on and so forth. However, a few senators there in the Philippines were made aware of the fact that they had received funding from the union, bloomberg, whatever, and they brought it up. They had a congressional hearing about it because they said, wait a minute, you've got foreign actors coming in here trying to write policy for our people without understanding what is going on with our people and what's going on. They took it very badly. They took it as, again, you've got an invader or a colonizer coming in here and trying to tell us what to do. During this hearing, it came out, and the FDA admitted that they had received funding. That was the watershed moment for regulation in the Philippines. That was why the vape bill that came through their Congress and the House of Representatives and is now going to be presented to the President, was able to get as far as it has gotten was because of the meddling in local policy and people getting very angry about it. So, Nancy, on the union's website, and I'll throw it up on screen here, when I put this into editing, is a whole series of prepackaged regulations that they've got that's designed to basically be handed to a country much like the ones in Asia. Is that what you found, is that they're pushing and pedaling these prepackaged regulations? Yes. And they're not just doing it in Asia Pacific, they're doing it in Latin America. They've done it, tried it in Mexico, they're trying it in Africa. It's LMIC's low and middle income countries. They're trying to infiltrate low and middle income countries to control the narrative control policy, and isn't part of their kind of pitch as saying, look, you don't have the resources or the bandwidth in order to properly regulate these products, and so here, take our legislation and our advice and our money and just go ahead and ban the products altogether. Yes, that's exactly what they're doing. But the problem with that, some of these countries looking to go, wait, they're going to write it for us, they're going to give us money. Great. Especially now in the post covered world, we're still in coveted, but you know what I mean. But the problem is that those regulations do not take into consideration the things that are happening on the ground and the people that are clued up are like, wait a minute, there's something wrong with you. You can't wholesale apply a policy across multiple countries without acknowledging the situation that's happening in the country. Now, around this time last year, there was quite a push from people in the media and for instance, Michelle Menton from the Competitive Enterprise Institute came out with a column that kind of coined the phrase philanthropolonialism as what's going on here? What do you think about that? She's spot on, dead on. I mean, that is the perfect term for this because a lot of people need to understand or remember perhaps that in Asia a lot of these countries were originally colonized or yes, colonized is a good word. The Spanish, the Dutch, the English, even Americans. Okay, so that foreign colonization thread runs very strongly through Asia. Yes. So it's a perfect term. So are these actions moral or is it part of the problem is that they are acting morally in their mind. I think originally people felt it was a moral imperative to help lower and middle income countries. I think that they don't have the resources, they don't have the knowledge, they don't have the expertise. Let's help them. But when you're trying to help someone without actually working with them, you're not helping them. And that actually just makes too much common sense to actually be honest. Yeah, but that's how it is. That's how it works. We've had a discussion about Bloomberg and that originally his force was on tobacco. And the thing that's interesting is we all kind of agree that tobacco kills people. We do all agree with that and we do all agree we need to give people options. But once he switched it to nicotine and vaping, it was like, wait a minute, what happened here? There's a kind of a feeling in the west that many countries in Asia are a bit more autocratic and maybe totalitarian in some manner or another. I think it's just an impression that we have. I'm in Canada, so I can't really say much on that topic anymore. But is there some truth to that when it comes to that area of the world? Yeah, there is some truth to that. But then I would counter that some countries give the premise or the look on the outside of being democratic when really it's not as democratic as it seems. So the difference, of course, in Asia is that I'm going to give you a little sociology lesson. In the Western world it tends to be a very individual society, the benefit of the individual, the rights of the individual. Whereas in Asia Pacific it's more about the collective, it's about who you know, it's about connections, it's about networks. If you have that, you can get things done. Does an individual focus work as an argument here in North America and other Western countries, there's a predilection to be using a rights argument, a liberty argument. Do those arguments work on behalf of THR in Asia Pacific? Yes, but on a bigger scale. For example, I'll give you a classic example. There have been rumblings from the west about some of the policies that are being proposed here in Asia. For example, Malaysia and their Vape tax. They're going to put a tax on the eliquid, both nicotine and non nicotine. I think it's the equivalent of four US cents per milliliter. Now, there are people that are up in arms in the west about this. Oh, my God. A tax. People in Malaysia are okay with it. I mean, they'd rather not have it, of course, but if they need to make the compromise in order to have a legal and regulated market, they're okay with that. And that's something that I don't think a lot of people in developed or Western countries can understand the concept of compromise. Because it's not about your individual. Right. It's about the greater good. So it's a more collective focus, I guess, then. Yes, it's a collective focus. Absolutely. So, talking specifically about Malaysia, and I think maybe Thailand might also be the case. But is there not a date of birth ban that's been put in place? Not in Thailand yet. But in Malaysia? Yes, in Malaysia, as of 2036, anyone who is born after 2005, I believe, will never be able to purchase tobacco or Vaping products legally. Legally? How is that going over? The consumer advocates and the people who are vapors in Malaysia are okay with that because they advocate for adults to have safer choices. You could not choose them to be a recreational nicotine consumer. If you were born after a certain date, I'm sure you could choose it, but you're not going to be able to do it legally. So about that, then. What is the potential for explosion of the black market? It already exists. I mean, let's be honest. The black market exists, and it's very vigorous in Asia. And regulation is not necessarily going to do much to stem that tide. However, the point of the regulation is to give adult smokers the options that they need to get off of the tobacco. You mentioned that some of the Western advocates were kind of in a kerfuffle over the tax. Did they have the same kind of reaction to the date of birth then? Yes, they did. Some did. And it's interesting to me because here I am sitting in New Zealand, and they're proposing the same thing here in New Zealand. And no one was up in arms about when New Zealand proposed it, but they were up in arms about Malaysia proposing it. Interesting. Yeah. I mean, I can understand that a certain reaction to that. It seems unequal. If they're safe products and they're okay for people to use, then why just set an age band on it and that's it? But the date of birth ban seems prohibitive. It does. I can see both sides of this. It does. However, and I brought that up to one of the Malaysian advocates, and he said, Nancy, listen. He goes, if these kids because they're kids now, they're all about 1516 now, but if these kids cannot access tobacco, they're not going to need vape and conceivably by 2036. Who knows what the law is going to be? Will it still be in place or will it not? But the point, the ultimate end game here for this is choice and access for adults. Now, you say 2036. Is that when it kicks into effect in Malaysia? Yes. Well, I can understand that a compromise is a compromise. It feels like a settlement. Yes, it does. But again, the collective the greater good when we're talking about China, and this is also relating to the global vape issues with China and the new regulations, one must understand that it was never legal to vape anywhere in China or in their territories. So Hong Kong has already gone ahead and banned. Taiwan will probably go ahead and ban as well, and China will institute very strong restrictions for anybody using any of these products within the country. However, I do want to make the point that it should not, according to experts, affect the global vape market. Yeah, that is definitely the concern in terms of hardware and everything else that comes out of China. It's indispensable for the global market. Yes. But the manufacturers are independent, and the Chinese government is not going to want to lose all that revenue. So when you take a look at everything that's going on in Asia Pacific right, and you have to rate where the vaping battle stands, how do you rate it in terms of things are going well? Things are not going well. I think things are going much better at this point in time than they were at this point in time a year ago. I think we're seeing a sea change. I think we're seeing a movement towards people, adults in Asia Pacific, having access and choice, and that's a good thing. What do you think was the single biggest determinator for why things changed around? I think part of it had to do with what went on in the Philippines. I think that really kind of kicked off other countries going, hey, wait a minute. I also think a lot of it has to do with the work of the advocates. The advocates in Asia Pacific are probably the most hard working, dedicated people I have ever met. And they work well, so well together. It's just amazing to see. It's a beautiful thing to see. Nancy, I know you'll be speaking at the Global Forum on Nicotine at the conference in Warsaw, Poland, this June 16 or 18th. Why is a conference like GFN important. And what might your message be? GFN is important because GFN gives advocates the ability to network with other advocates because this can be a very lonely gig. It also gives them the tools and the information that they need to be able to go back out there and know what they're talking about. And also it's reinvigorating. It gives you your mojo back. It gets dragged down when you go in there and you're hanging out with people that you know, that understand what you're doing and you leave there and you feel reinvigorated and ready to go to battle. I am going to be giving a presentation on community, how the Asia Pacific region came to be Caffre and what we do and how it works and why it works as well as it does for the members of the collaboration. And how can advocates outside of Asia helping you fight? I think a lot of times we need to understand that we're all fighting the same battle, but we're on different theaters of war and we need to support one another in such a way that we don't step on each other's toes, but that the support that we're giving is actually helping and not harming. So is this fight over? Done and dusted? No, this fight will never be overdone and dusted because there will always be changes of government and changes of mentality and there will be the who coming down with something else ridiculous coming in. It's an ongoing battle. It's a marathon, not a dash, and it requires vigilance and it requires engagement. Thank you, Brent and Nancy. We look forward to seeing you both in wars of this summer. That's all for today. Thanks for watching and see you next time for more tobacco harm reduction updates and brands for coming into interview with Jim Merlin, goma Elizabeth, tobacco harm reduction advocate from Malawi. Goodbye for now.