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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


Hello and welcome to GFN News on GFN.TV. I’m your host, Joanna Junak.

In today’s news:

The US Food and Drug Administration receives new powers to regulate synthetic nicotine. We’ll hear more from Will Godfrey of Filter magazine

In Australia, the state of New South Wales has launched a Campaign to stop young people vaping. Dr Colin Mendelsohn shares his thoughts.

More tobacco harm reduction experts say that smoke-free products will help the Philippines reduce their smoking rate. We’ll hear more from one of them.

And after the news, Brent Stafford of RegWatch interviews Nancy Loucas, Executive Coordinator of CAPHRA and GFN22’s third keynote speaker.

On 15 March 2022 U.S. 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. 

Joanna: Let’s cross over to Will Godfrey from Filter magazine. Hi Will.

Will: Hi Joanna.

Joanna: Tell us, what does the signed bill mean for American consumers?

Will: Frankly, no one is sure at this point but it looks ominous. The new law is a result of increasing legislative focus on synthetic nicotine, which we’ve also seen with the introduction of state-level bills that would effectively ban it. Synthetic nicotine has previously been seen as a legal grey area, because the FDA’s remit only extended to tobacco-derived nicotine; that has allowed continued sale of the flavoured synthetic products that many former smokers rely on. Now, companies that sell these will have to submit Pre-market Tobacco Product Applications to the FDA just like other vape companies did - and it hasn’t gone well the first time around, with just one vape authorized and reams of marketing denial orders issued, many of which are being contested in court.  The new PMTAs will have to be submitted within 30 days after the new law takes effect in mid-April, which seems an impossible ask given the long-term studies required.  The FDA will have 60 further days to decide whether products with pending PMTAs can stay on the market.

Joanna: And what happens if the FDA does not make its decisions on time?

Will: It seems certain, based on past performance, that the FDA won’t issue authorizations in anything like that time-frame; even heavily resourced applications from the likes of Juul are still pending more than 6 months after the last deadline passed. It boils down to whether the FDA will issue loads of marketing denials right off the bat, or whether the agency will exercise its enforcement discretion to take products off the market while applications are pending. Either scenario means the rapid removal of options for former smokers.

Joanna: The last question, Will. Where do Puff Bar's products come into this?

Will: Puff Bar has become the latest bête noire 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 to regulate synthetic in general. Like many others, the company switched to synthetic, to continue operating after its initial PMTAs were denied. It will now have to submit new PMTAs like all the rest.

Joanna: Thank you, Will. See you next time. The Australian state of New South Wales (NSW) has launched a campaign “Do you know what you're vaping?” to persuade young people to stop vaping. The campaign is aimed at secondary school students. The campaign states that vaping is not safe and can have harmful, long-term effects on the physical health and brain development of young people. Minister for Health and Medical Research for New South Wales Brad Hazzard has said that research has proven that e-cigarettes 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.

More tobacco harm reduction advocates are in agreement that the 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 appealed to President Rodrigo Duterte to veto the 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 vaping bill would be so important for Filipinos." And what would happen if President Duterte did not sign the bill."

Dr Colin: 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 smoking related disease.

Joanna: Thank you, Colin for sharing your insights. And now, we go over to Brent Stafford and his guest, Executive Coordinator of CAPHRA, Nancy Loucas. In June, Nancy is set to deliver the third keynote speech at GFN22 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 Asia Pacific Advocates Fight for Safer Nicotine. Over to you, Brent. 

Brent: Hi, I'm Brent Stafford, and welcome to RegWatch 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 Loucas from The Coalition of Asia Pacific Tobacco Harm Reduction Advocates or CAPHRA. CAPHRA 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 RegWatch.

Nancy: Thanks for having me, Brent. Much obliged.

Brent: So first off, tell our viewers about Caffrey. How did it start, what regions does it operate and what's its purpose?

Nancy: Ok, Cafe is a coalition of voluntary coalition of consumer 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 cafe 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 contexts. 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.

Brent: So how does the battle the kind of fight affect each of the different countries and how do you work together?

Nancy: Well, again, there's 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, OK? 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 manufacture and production. So it's an interesting. Way of looking at things, let's put it that way that other people can't quite understand.

Brent: So top line for us, the battle in Asia, like 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 you know, assuming Vaping, you know, are they pro vaping generally in Asia? A. Vaping, how does that work?

Nancy: 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 the W.H.O.. However, that being said, a lot of the reason outside of the W.H.O. that there is very strong anti air sentiment is that there is a lot of meddling in public policy coming from foreign actors from overseas. It was very 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 worked in their favor because now they're looking towards having a legalized regulated market in the Philippines. So there's a 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.

Brent: So you have an excellent promo video that's on The Advocate's Voice, where you take on the W.H.O. and its recent report on e-cigarettes, let's just have a quick listen.

Brent: Now, that was excellent, isn't Texas, albeit editing? But here we go. That is an excellent video, what was the response?

Nancy: Well, people on the protein are side, but 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? I mean, it's not like they talked 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, You know, we need to get a little angry here. We need to kind of call them out and I'm like, OK, go for it. And that's what we got.

Brent: 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.

Nancy: It is, and it isn't. Yes, in many ways it is very similar, but in other ways because of the other aspects including, you know, 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 and different in different arenas. And we need to understand that there are slight differences across that. Yeah, but mainly, yeah, we're all fighting the same battle. Absolutely.

Brent: Some of the tried and true pieces of misinformation and tactics that have been used by A. Vaping opponents over time here in North America get retried like pulled rethreaded out in the other markets, such as the Asian market. Is that the case?

Nancy: 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 pro air tend to stay on the down low simply because of the way the governments 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 just 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.

Brent: How involved has Bloomberg and his advocacy organizations been in Asia?

Nancy: 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 merely 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.

Brent: So for our viewers, that might not be familiar with what happened in the Philippines. Walk us through that.

Nancy: Ok. In the Philippines, first of all, in the Philippines, President Duterte has always been very anti-smoking and anti-Vaping, you know, I mean, he is not somebody you want to mess with. Ok. And what happened was that the union, I believe it was the union, went in and supported 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, you know, 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 their 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.

Brent: 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 pre-packaged 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 is that they're pushing and peddling these pre-packaged regulations?

Nancy: Yes, and they're not just doing it in Asia Pacific, they're doing it in Latin America. They've done it and tried it in Mexico. They're trying it in Africa. It's LMICs, low and middle income countries. They're trying to infiltrate low and middle income countries to control the narrative and control policy.

Brent: And isn't part of their kind of pitch is 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.

Nancy: Yep, that's exactly what they're doing, but the problem with that, I mean, it is, you know, some of these countries look at and go, Wait, you know, they're going to write it for us, they're going to give us money. Great, you know, especially now in the post-COVID world, we're still in COVID, 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 here, you can't wholesale apply a policy across multiple countries without acknowledging the situation that's happening in the country.

Brent: Now, around this time last year, there was quite a push from people in the media and for instance, Michelle Minton from the Competitive Enterprise Institute came out with a column that kind of coined the phrase philanthropy colonialism…

Nancy: Yes.

Brent: What's Going on here? What do you think about that?

Nancy: She's spot on dead on. I mean, that is a perfect term for this, because a lot of people need to understand or remember, perhaps that, you know, in Asia, a lot of these countries were originally colonized or colonized is a good word. The Spanish, the Dutch, the English, even Americans. Ok, so that foreign colonization thread runs very strongly through Asia? Yes. So it's a perfect term.

Brent: So are these actions moral or is it part of the problem is that they are acting morally in their mind?

Nancy: I think that some 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.

Brent: Right. And I and that actually just makes too much common sense to actually be followed, to be honest.

Nancy: Yeah, but that's how it is, that's how it works. You know, we've had a discussion about Bloomberg and that originally, you know, his his force was on tobacco and you know, the thing that's interesting is we all kind of agree that, you know, 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?

Brent: You know, 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. You know, I'm in Canada, so, you know, I can't really say much on that topic anymore. But is there is there some truth to that when it comes to that area of the world?

Nancy: Yeah, there is some truth to that, but then, you know, I would counter that, you know, 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 let's sociology. 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.

Brent: So does an individual focus work as an argument here in North America and other Western

countries? There's a predilection to be using, you know, a rights argument, a liberty argument. Do those arguments work on behalf of air in Asia-Pacific?

Nancy: Yes, but on a on a bigger and 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 their E-Liquid, both nicotine and non-nicotine. I think it's the equivalent of four U.S. cents per millilitre. Now there are people that are up in arms in the West about this. Oh my God, a tax. People in Malaysia are OK 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 OK 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.

Brent: So it's a collective focus, I guess, that.

Nancy: Yes, it's a collective focus, absolutely.

Brent: 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?

Nancy: Not in Thailand yet, but in Malaysia, yes, in Malaysia as of twenty thirty six. Anyone who is born after twenty five, I believe, will never be able to purchase tobacco or Vaping products.

Brent: Legally.

Nancy: Legally.

Brent: Now that's I mean, how is that going over?

Nancy: The consumer advocates and the people who are vapers in Malaysia are OK with that because they advocate for adults to have safer choices.

Brent: So you could not choose then to be a recreational nicotine consumer if you were born after a certain date.

Nancy: I'm sure you could choose it, but you're not going be able to do it legally.

Brent: about that, then, what is the potential for, you know, explosion of the black market?

Nancy: It already exists, I mean, let's be honest, the black market exists, and it's very vigorous in Asia, and, you know, regulation is not necessarily going to do much to stem that tide. However, regulation the point of the regulation is to give adult smokers the options that they need to get off of the tobacco.

Brent: 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 ban?

Nancy: Yes. Yes, they did, some did. You know, 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 it when New Zealand proposed, but they were up in arms about Malaysia proposing it. Interesting.

Brent: I can understand that a certain reaction to that it seems unequal like, I mean, if they're safe, if they're safe products and they're OK for people to use and why. You know, just set an age ban on it. And that's it. But the date of birth ban seems, you know, prohibitive.

Nancy: It does. I can see, you know, 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, a little about 15, 16 now. But if these kids cannot access tobacco, they're not going to need Vape and conceivably by twenty thirty six, who knows what the law is going to be? Well, it's still be in place. Or will it not? But the point, the ultimate point, the the ultimate endgame here for this is choice and access for adults.

Brent: Now you say twenty thirty six, is that when it kicks into effect?

Nancy: In Malaysia, yes.

Brent: Well, I can understand that a compromise is a compromise, it feels like a settlement.

Nancy: Mmhmm. Yeah, it does, but again, the collective, the greater good.

Ok, 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.

Brent: Yeah, that is definitely the concern, you know, in terms of hardware and everything else that comes out of China, it's indispensable for the global market.

Nancy: Yes, but the manufacturers are independent and the Chinese government is not going to want to lose all that revenue.

Brent: So when you take a look at everything that's going on in in Asia Pacific, right, and you have

Nancy: Hmm.

Brent: To rate where the Vaping battle stands, how do you rate it in terms of things are going well, things are not going well.

Nancy: 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.

Brent: What do you think was the single biggest denominator for why things changed around?

Nancy: 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. Hmm. 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 hardworking, 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.

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

Nancy: 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. I mean, and also, you know, it's reinvigorating. It gives you your mojo back, you know, it gets dragged down, you know, and 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 [00:25:00] on community how the Asia-Pacific region came to be kafala and what we do and how it works and why it works, as well as it does for the members of the collaboration.

Brent: And how could advocates outside of Asia help in the fight?

Nancy: You know, 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 [00:25:30] 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.

Brent: So is this fight over done and dusted?

Nancy: No, no, this fight will never be over done and dusted because they will always be changes of

government and changes of mentality, and there will be the ho coming down with something else ridiculous coming in. You know, it's it's an ongoing battle, it's a marathon, not a dash, and it requires vigilance and it requires engagement. 

Joanna: Thank you Brent and Nancy – we look forward to seeing you both in Warsaw this summer. That’s all for today. Thanks for watching and see you next time, for more tobacco harm reduction updates and Brent’s forthcoming interview with Chimwemwe Ngoma, a leading tobacco harm reduction advocate from Malawi. Goodbye for now!