Why is it easier to launch a deadly new cigarette than a safer alternative? In this video, Harry Shapiro (Director of DrugWise UK) sits down with tobacco policy journalist Jacob Grier to untangle the chaotic, confusing, and highly politicized world of tobacco harm reduction.
From the historic roots of the FDA’s Tobacco Control Act to the massive influx of unregulated products, they break down why public health regulation is failing consumers, creating monopolies, and inadvertently fueling a massive illicit market.
Transcription:
00:03 - 00:29
[Harry Shapiro]
Hello. Good afternoon, good morning or good evening, depending where you are in the world. My name is Harry Shapiro. I'm the director of Drugwise, which is a UK drug information service. And I'm here to talk UK tobacco harm reduction policy and maybe other things as well with Jacob Greer, who's a writer and journalist on tobacco policy.
00:29 - 00:32
[Jacob Grier]
Thank you for having me on. Hello. It's great to see you again.
00:33 - 02:30
[Harry Shapiro]
So from a public health perspective, at the risk of being simplistic, life used to be quite simple from a regulatory point of view. Cigarettes were and are bad. They cause cancer and all sorts of other nasties. So you can have smoking bans and age restrictions and all the things associated with tobacco control. But it was really just focused on one product. You had a few leaves wrapped up in some paper, simple. But once you could decouple the nicotine from the cigarette, it was an existential disruption. You have multiple products and specifically with vapes you have different flavours and different nicotine strengths in different sized bottles. And then the whole won't somebody think about the kids comes back on the agenda once again. So generally it's a legislative and political upheaval or chaotic as some people might call it. And I think a microcosm of all of what's been going on, given that it's the biggest market in the world for safer nicotine products, is the USA, where you have states' rights, where they have constitutional rights over certain aspects of policy, including health. You have federal regulation. And sometimes the states are in conflict with what the federal regulation might be. But as we will discuss, there's also been conflict at a federal level as well between the White House and the Food and Drug Administration. So can you sort of... take us through that minefield as best you can, which must be incredibly confusing for manufacturers and consumers alike.
02:30 - 06:26
[Jacob Grier]
Yeah, manufacturers, consumers, media, it's confusing for everyone. The United States system for regulating tobacco products in general and nicotine products is not one I would recommend. as a model for other countries, to say the least. And I think to understand it, we should go back to actually how the Food and Drug Administration, the FDA, came to regulate tobacco in the first place. And it goes back to what you said at the beginning, which is that it used to be a very simple landscape. You were mostly concerned about cigarettes, a little bit of chewing tobacco, but the objective was fairly simple, which is how do we stop people from using less tobacco and suffering these health harms? And so starting around the turn of the century, around 2000, discussions began happening about how do we give the FDA authority over tobacco products. And as you would probably imagine, the initial coalition was that public health was in favor of this and tobacco companies would be opposed because they oppose regulation. But I think what happened is the tobacco companies realized that some regulation was going to be inevitable. And so their best bet was to make sure that whatever regulation came about was going to be as favorable to them as it could be. And so around the early 2000s, you actually see that what became the Tobacco Control Act, signed in 2009 but going back much older, was actually pushed by Philip Morris, which then eventually became Altria, which, if anyone doesn't know, is the largest manufacturer of cigarettes in the United States. And so we think of this as a public health law, but you have to understand that it's also equally an anti-competition law. So the largest tobacco company in the United States wanted to keep their market share. And so the law is designed to do two things really right up front, which is one, make it very hard to introduce new cigarettes. and to market new cigarettes. So the Philip Morris market share for Marlboro and for their menthol cigarettes was protected from competition. And then, too, to also make it much harder to introduce competitive products that we now think of as e-cigarettes or snus or nicotine pouches, which were very much in their infancy at the time. But I think the gamble, if you were Altria, is that you have the resources to get through a regulatory bottleneck better than smaller companies or just about anyone else. And so we end up in this system where it's very hard to introduce any new products, but it's easier to introduce a cigarette because the way the law is written, to introduce a cigarette, all you have to do is say that it's substantially equivalent to what came before. So in other words, the new cigarette we want to introduce is just like the ones that are killing millions of people every year. But if you want to bring out a safer product, an innovative product, you have to go through way more regulatory hoops to introduce it. And so that's been the biggest problem at the federal level in the United States. is that all this innovation has been happening in snus and e-cigarettes and nicotine patches, but the system we have set up to regulate them doesn't create any industry-wide guidance, really. It doesn't tell you, you know, if you meet these specifications, you can market your product. It requires every single product submit what they call a pre-market tobacco application to be authorized for sale. And if you haven't gone through that process, you are technically in violation of the law. This is very clear. And so in 2016 is when the FDA came out and said, we're deeming e-cigarettes to be part of our purview. They count as tobacco products now. By this time, the e-cigarette market was already growing. There were lots of vapes. And so this process was put in place. They initially received six and a half million applications for various vaping products to come in. Now, right off the bat, they decided two million of these are essentially spam. They cut those out, which I think they were probably right about. You still have four and a half million.
06:26 - 06:33
[Harry Shapiro]
Let me interrupt you. It can't be four and a half million different vapes.
06:33 - 07:27
[Jacob Grier]
We have to assume there's lots of variants here. And I think a lot of companies were just trying to put everything they could think of into the system to get it there. And the way it's written too is every component has to be in there. The actual device, the flavor, the nicotine concentration, the cartridge, like every component is part of this. And so you don't actually, so like I said, the FDA takes over in 2016. I believe the first authorization of products maybe is 2019. But if we jump forward to today, 2026, a full decade after the FDA began regulating e-cigarettes, the grand total that have ever made it through this process is 45. So 45 out of 45 million, or 4.5 million, you can do the math. This is a very tiny percentage. And even that is misleading because like I said, that's the components of EG cigarettes. So it's less than 45.
07:27 - 07:29
[Harry Shapiro]
So it could be half a dozen products.
07:29 - 07:49
[Jacob Grier]
Exactly. And so there's very little that is actually authorized in the U.S. But as you know, we have a massive market. This is not representative of what people are actually buying. There are tens of thousands of vapes being sold throughout the United States and all kinds of flavors. And so at the federal level, that's basically the state of play. So why...
07:51 - 08:07
[Harry Shapiro]
Why? I mean, I couldn't give any other word, but why have the FDA taken this position on safer nicotine products? When, like you say, all you've got to do is produce a cigarette and you're off to the races.
08:07 - 08:50
[Jacob Grier]
And this is why I would not say anyone should emulate the United States, because the way the law is written, each product needs to be assessed individually, and it needs to be assessed not in comparison just to a cigarette. It's not just, is an individual user better off using this e-cigarette versus smoking a regular cigarette? It's what is the population level effects? And so in the United States, there's massive concern about youth taking a vaping. And I think the political sensitivity of the youth vaping issue has just made the FDA extremely cautious about doing anything in terms of, you know, they didn't want to be the ones who authorized Juul after all the paranoia about Juul in the early 2000s and the genuine things that Juul got wrong.
08:50 - 08:51
[Harry Shapiro]
Yeah, yeah.
08:51 - 09:03
[Jacob Grier]
And so, you know, we didn't get a non menthol flavoured vape authorised in the United States until last month. More than a decade into the process.
09:03 - 09:47
[Harry Shapiro]
Right. So now we have some products. I think another aspect of this is The flavour product that has been authorised is from a company called Glass, or Glass, however you pronounce it, who are not, you know, one of the big four, five, whatever. But up to now, all of the products that have been authorised have come from what you'd call big tobacco. Is that coincidental? Or is it just that they're the only ones up to now... who've been able to afford to put something through that process.
09:47 - 10:21
[Jacob Grier]
Yeah, I mean, you absolutely need the funding to do it and to do the research that's required. And I think it's also worth mentioning that they have the age-gating technology. So to make their e-cigarette functional, it has to be paired by Bluetooth with a phone, which has then been tied to a user through a government ID process. And so the idea is that, from the FDA's perspective, youth are unlikely to go through the steps to use this product, which I think is realistic if for no other reason that there are thousands of unregulated products on the market that they can use instead.
10:21 - 10:31
[Harry Shapiro]
So, I mean, they've authorized, I think, blueberry and mango, which seems a bit random, considering Glass have got about 30 flavors.
10:31 - 10:45
[Jacob Grier]
And even on this, we talk about what a modest step this is and how little it actually changes, but absolutely criticized across the board by public health groups and by a lot of politicians for even making this very minor change.
10:46 - 10:56
[Harry Shapiro]
But even then, apparently, as you've written about recently, the FDA was sort of dragged screaming to the table in order to even make this modest change.
10:56 - 10:57
[Jacob Grier]
That's true, yeah.
10:57 - 11:00
[Harry Shapiro]
There's a bit of a political background to this.
11:00 - 11:23
[Jacob Grier]
Yes, and so even now it does appear that there were certain people in the FDA who wanted to approve these products but it was very much a top-down command from the reporting that we've seen on it from the President Donald Trump coming in and saying like we need to authorize these and we need to have the enforcement discretion to leave others on the market right and from a political point of view
11:25 - 11:35
[Harry Shapiro]
whether it's a Republican thing, I don't really know, but there was political pressure. And so where is the political divide on this? Generally in America.
11:36 - 12:54
[Jacob Grier]
In America, we've always had Democrats being more anti-tobacco and Republicans being more pro-tobacco, at least in recent decades. When Democrats had more political power in tobacco-growing states, it was a little bit different. But it's become identified with the right throughout a fairly long period. uh and i think that is part of the problem in the u.s uh and this gets really deep into our own unique political pathologies that we're dealing with right now yeah sure but it it is very frustrating to me because i live in a very liberal democratic part of the united states in portland oregon which is a place where we were one of the first to legalize cannabis yeah we have a very liberal culture towards alcohol we've legalized psychedelic therapies We recently decriminalized all drugs across the board in the entire state of Oregon. We did actually backtrack on that a little bit. But at the same time, when I talk to people in Portland, they're extremely anti-vaping in anything related to nicotine. And it's a very strange divide where you can have a fairly liberal approach to almost any other drug in states like mine, and yet extreme hostility to any use of tobacco or nicotine.
12:54 - 12:58
[Harry Shapiro]
Right. So they'd be quite happy to see vapes banned or something.
12:58 - 13:06
[Jacob Grier]
Absolutely. And where I live in Portland, you can buy candy-flavored cannabis, but flavored vapes are illegal to sell.
13:07 - 13:26
[Harry Shapiro]
And of course, I mean, the American, it's interesting because I'm assuming that are all the states American states roughly aligned, or just subtle differences between the legislation in different states, or are there big differences?
13:26 - 14:55
[Jacob Grier]
Yeah, and that's the other challenge in the United States. We talk so much about the FDA and the federal situation, but the state situation is they can do what they want. They have a lot of power. So we have five states in the United States that have banned the sale of all flavored vapes. And we have a sixth that has banned all but menthol. So we can have all these conversations about how to improve the FDA process to make sure that some other flavored e-cigarettes get through. But the bottom line is that any state could, and many have, made them illegal anyway. And it's big states. California is the biggest state in the United States. New York is fourth. And in both of those, you know, all flavored e-cigarettes are illegal, regardless of what the FDA does. And that applies at a city-wide level as well. Like, you know, my county in Oregon has banned them, and so have many other places. And this is where I think the question of political divides gets really complicated as well, is I am worried that having people like Trump or our health secretary, Robert Kennedy Jr., have some very fringe ideas about public health, becoming the face of tobacco harm reduction and of flavored vapes is going to polarize other places against it. And so when they see someone like Trump or Kennedy advocating vapes and they see headlines about how tobacco companies donated $5 million to Trump's super PAC, his political advocacy group, the week before these changes come through, a lot of them are quite rationally going to think, Hello. This is not good, and my state should regulate it away.
14:55 - 15:05
[Harry Shapiro]
But, I mean, that said, I think we would both agree that tobacco harm reduction hasn't exactly got a marvellous press at the moment. You sort of feel, how bad can it get?
15:06 - 15:17
[Jacob Grier]
Right. We're in a tough situation where you want every ally you can find, but you do have to worry about if you have... allies who have no credibility that could make it worse for you in the long term.
15:17 - 16:23
[Harry Shapiro]
But I mean, it's interesting because you've got the Argentinian president, Mille, I think is the name, if I pronounced that correctly, who, and they've just liberalized their vaping policy. He's been quoted as saying he's up for freedom of choice on drug policies, actually in favor of legalization. on a continent that is fairly anti-tobacco harm reduction, maybe with the exception of Chile. It does sort of feel that the far right populists are getting on the bandwagon of vaping. I'm sure it's got nothing to do with public health. Much more to do with vote catching and proving their... Because he's had this thing about, you know, tackling the bureaucratic elite, which is exactly what goes on in America and the populist view that we want minimal government and stuff like that. So I suppose this is all part of a thing, isn't it, really?
16:23 - 16:56
[Jacob Grier]
It is, and we talk about these changes, but the things that have happened in the U.S. are still pretty minor when you look at what's happening on the ground. We come into this conference and we can say there's been some very big symbolic changes. We've authorized flavored vapes for the first time. The FDA has said there are going to be lacks on enforcement about ones that haven't made it through the process. But really, this is just recognizing the reality on the ground. Yeah. Whether states have banned it or not, whether they're authorized by the FDA, almost all of the vapes sold in the U.S. are illegal. And they're very accessible.
16:56 - 19:38
[Harry Shapiro]
It's a very similar situation in the U.K., actually. The U.K. has always been one of the poster countries for acceptance of tobacco harm reduction as an idea and product availability and all the rest of it. But we're still swamped. With illegal drugs. I mean, we've got a tobacco and vape bill. The tobacco bit is about the smoke-free generation stuff, which clearly has its critics. The vape side of it... aims to sort of go much further than the European tobacco products directive, to which we've already, we're still signed up to, even though the UK is not in the EU anymore, it still goes by. But that's fairly modest compared to what could happen under the vape bill, you know, banning this and clamping down on that and all the things that make... But I was looking at this the other day, that there are... something like 80,000 potential retail outlets in the UK that sell vapes against probably no more than 1,500 local authority trading standards offices who deal with everything from fireworks to alcohol to tobacco. So vapes is a tiny bit of what they have to do. And there's also lots of stories in the UK about vape shops being controlled by organised crime and all the rest of it, which I suspect almost certainly happens in Australia and other places where they've got... What's your sort of, I suppose, what's your kind of take on the fact that, you know, what you might call Pandora's box, you've got this explosion, mainly vapes, less so pouches and less, and heated tobacco products, which are obviously a lot more expensive. But the illegal products in the States and elsewhere, they're not necessarily illegal because they're dangerous or they're badly made or whatever. They're simply skirted round, you know, border control or all the rest of it. So in what way does the American authorities, whoever it might be, I mean, are they anywhere close to trying to, you know, a kind of political... expression of clamping down on things, you know, politicians like to clamp down.
19:38 - 19:46
[Jacob Grier]
Yeah, I mean, they definitely like to make the effort and make a show of it. Yeah. And we've seen this even with the current administration, you know, which is seen as being pro-vaping.
19:46 - 19:46
[Harry Shapiro]
Right.
19:46 - 20:07
[Jacob Grier]
But the reality is, you know, Kennedy has been giving press conferences at seizures of Chinese vapes, and so it's actually portrayed in a very different way. Yeah. As being, like, anti-China, where, like, we're... Right. Like so many other things. Yes, we want to make American vapes and have those on the market. And it has nothing, very little to do with the actual quality or risk of the product.
20:08 - 20:27
[Harry Shapiro]
No, no. But it's interesting about Chinese, because everyone sort of, you know, I mean, Reynolds Interestingly, you know, I've got 30 flavors that they can't sell in the state. They can't get authorization in the state. So maybe their donation was a push in the direction of getting more flavors.
20:27 - 20:53
[Jacob Grier]
And that gets back to the anti-competitive effects of the law, too, because you have companies like Reynolds and Altria who have major assets in the U.S. who are very legible companies. And they have to obey the law because if they don't, they can get in big trouble. And so you do understand their perspective of basically seeing the market being taken over by very shady companies with no real presence. But it's also not good for public health to be monopolizing vapes and cracking down on all these illicit products.
20:53 - 21:12
[Harry Shapiro]
I always get the sense that given the companies that have authorization, this is maybe completely simplistic and silly, but I get the feeling that the officials at the FDA like to deal with people who are like them. They turn up with suits and ties and smart suitcases.
21:12 - 21:17
[Jacob Grier]
Sometimes they leave the FDA to go work for tobacco companies. Yes, they're called the revolving door. Yeah, exactly.
21:17 - 23:16
[Harry Shapiro]
Rather than dealing with some aged hippie wearing a Jimi Hendrix T-shirt, they're supposed to run a vape shop. This is just about running out of time. I've got the man in my ear telling me that, you know, but it's interesting because this chaos is really multiple. I mean, we talked about America as being a microcosm, of what happens all over the world in one way, shape or form that, you know, these products are everywhere. There's something like 200 million now consumers globally of all these different products. So it ain't going away. It's just unfortunate that organisations like the FDA and medical and public health organisations all over the world seem to be doing whatever they possibly can to stop people accessing safer products. And I'm sure there's a conversation we may have later on, or I may have later on with another interviewee, about the sort of moral outrage and exactly what prohibition is all about. Because this isn't really prohibition, because there are products everywhere and we know it doesn't work. So I'm going to wrap this up. I'm going to say thank you very much for your time. And thank you all out there for watching and listening. And I'll be back again tomorrow morning to talk about... to talk about nicotine addiction and how we understand that. And I'll be talking to Ariella Saylor, who's a behaviourist scientist, about the whole business of nicotine addiction and dependency. So I'll leave you now and thank you very much and goodbye.