Heat not Burn could gain from new FDA strategy

There’s been a lot of excitement among American vapers about Friday’s announcement from the FDA. The big news was that the deadline for submitting paperwork under the Deeming Regulations, which was set to wipe out 99% of all vapour products next November, has now been delayed for four years. But there was a lot more to the FDA’s announcement than that, and some of it is also important for Heat not Burn.

In his speech on Friday morning, FDA commissioner Scott Gottlieb outlined a new anti-smoking strategy for his agency. For the first time the FDA has publicly admitted that there’s a spectrum of risk for nicotine products, with traditional cigarettes at one end, nicotine replacement therapy at the other, and a whole range of products like e-cigs and HnB in between (in reality, very close to the NRT end). This moves the agency away from seeing reduced-risk products as another kind of cigarettes to acknowledging them as a potential solution.

As well as pushing back the deadline for Pre Market Tobacco Authorization submissions, Gottlieb says he’s also planning to make it easier to submit them. Up to now the process has been a complete nightmare. According to the FDA an application takes about 500 hours to complete and costs around $300,000 per product. Those who’ve actually done it say it takes thousands of hours and costs well over a million. Worst of all, it’s hard to tell exactly what should be in it. The FDA guidance document is 500 pages of impenetrable legal guff that nobody can understand, so for most businesses filling out the paperwork is guesswork – and, after spending all that time and money, there’s no guarantee the application will be accepted.

Expensive rules, unclear outcomes

So far we only know of one PMTA application for an HnB product; in March, PMI submitted one for their popular iQOS. That’s now under review by the FDA, although it could take more than a year for it to be approved or declined. The industry will be watching closely; if iQOS is approved it opens the door for rivals like BAT’s Glo, although iQOS will have a useful head start.

The PMTA process has been worrying a lot of people, because it hasn’t been clear how strict the FDA were planning to be. Up to now they seem to have looked at new nicotine products as a menace that should be kept off the market, and that was obviously bad news for HnB. There was a real risk that they’d want to avoid the “mistake” they’d made by letting e-cigarettes get onto the market, and take a hard line from the beginning.

Gottlieb’s new direction could change that. The FDA now seems interested in having healthier options available, and encouraging smokers to switch to them. Although the companies making HnB products are being careful so far not to call them reduced risk, there’s no doubt that they are. If the FDA has been keeping up with the science, they know that too.

Bad science strikes again

It has to be said that the FDA’s strategy has a huge problem. From what Gottlieb said, it seems that they want to cut the amount of nicotine in cigarettes as a way to force smokers towards alternatives. However, it’s not so clear why this should work. After all, we have evidence from when something similar was tried before.

Tobacco controllers still love to rant about how the industry “lied” to smokers when they released light cigarettes in the 80s and 90s. What they don’t mention is that it was tobacco control who pressured the industry to do that. The result, of course, was that people simply smoked more and took deeper puffs; they ended up inhaling exactly the same amount of nicotine, but a lot more toxic smoke.

Now the FDA seem to think they can try the same trick again but get a different result, which just begs for comments about the definition of insanity. To be fair they might get a different result this time, because now there are real alternatives to smoking, but it’s more likely they’ll just create a massive black market in smuggled high-nicotine cigarettes.

What will decide that is how effective the alternatives are at delivering nicotine. If the FDA’s brave new cigarettes aren’t very satisfying, but neither are the safer choices, most people will just either smoke more or call their dealer and ask when the next batch of proper Marlboro are due in from Mexico. On the other hand, if cigarettes don’t give enough of a nicotine hit but other products do, then people are a lot more likely to switch.

Vape or heat?

So far that’s been the big problem with e-cigs; unless you have decent kit and know how to use it, the nicotine hit isn’t as satisfying as a proper cigarette. Experienced vapers can completely turn that around, but for a beginner – especially somewhere like the EU, with its stupid 20mg/ml cap on liquid strengths – it can be a struggle to get as much nicotine as you’re used to.

Now a leading tobacco harm reduction researcher has compared a HnB product – iQOS – against both cigarettes and e-cigs. The results are interesting, especially in the context of Gottlieb’s plan.

Dr Konstantinos Farsalinos, a cardiologist at the Onassis Cardiac Surgery Centre who’s well known for his research into the safety of vaping, compared the amount of nicotine delivered by a tobacco cigarette, several e-cigs ranging from cigalikes to an advanced mod, and the iQOS. What he found was that while the iQOS still isn’t as efficient as a cigarette, but it comes very close – and it’s well ahead of the sort of e-cig people usually try when they think about switching.

If Gottlieb does push ahead with trying to cut the nicotine in cigarettes, a lot of US smokers are going to be very unhappy. Some of them – those who live near Canada or Mexico, for example – will probably just nip over the border to do their shopping. But the rest might be tempted by a product that has a familiar cigarette company brand, is distributed through the same retailers and delivers almost as much nicotine as their cigarettes did. This could be just what it takes to help Heat not Burn become huge in the USA.

Heat not Burn takes off in South Korea

When someone mentions Korea most of us think of the mad regime in the North. That’s a pity, because South Korea is much nicer – and, if you’re a fan of Heat not Burn, it’s also a lot more interesting right now. South Korea is now an expanding market for the leading HnB products, so much so that a local company is planning to join in.

Unlike its bizarre Stalinist neighbour South Korea is an advanced industrial country, with a relatively low smoking rate of 19.9% – slightly lower than Germany, but slightly higher than Japan. It also has tough anti-smoking laws that make it illegal to light up in almost any public place. The government is pretty serious about persuading its citizens not to smoke.

Unfortunately it has a couple of serious problems. The first, and probably the biggest, is the army. The country has the world’s sixth-largest standing army and second-largest reserves; in total it can mobilise 3.7 million troops, and all South Korean men have to do an obligatory 21 months of military service. This is a great way to defend against insane, highly militarised neighbours, but not so good if you’re trying to stub out smoking.

Soldiers smoke, often because it gives you something to do while you wait for the army to decide what’s happening to you next, and lots of Koreans pick up the habit while they’re in uniform. That 19.9% smoking rate? It breaks down into around 5% of South Korean women, but about 40% of men.

At the same time, vaping hasn’t really taken off in Korea the way it has in the UK or USA. It is possible to buy e-cigarettes, and there are some local manufacturers, but it hasn’t made a big dent in the smoking figures. Now, major tobacco companies are wondering if Heat not Burn can do a better job.

Here comes iQOS

HnB products are very new to the South Korean market; Philip Morris released its popular iQOS device on 27 May, and now has two stores in Seoul (if you like Korean music you’ll be pleased to hear that one of them is in Gangnam). They’re also selling the iQOS through the CU convenience store chain, which has about 3,000 branches across the country.

Philip Morris say they don’t have any firm sales figures yet but are seeing “growing popularity”. That sounds about right; an employee at a CU store says, “They have been all sold out every day.” It wouldn’t be surprising if this is the case because iQOS continues to do very well in Japan; it took a 0.8% share of the cigarette market in the first quarter of 2016, but had climbed to 4.5% by the end of the year. PMI say it’s now at around 7%.

With the iQOS apparently doing well in South Korea, British American Tobacco are aiming to introduce their rival Glo device in August. Glo is a similar format to iQOS and BAT Korea say they’ll be selling it at a slightly lower price. If they can get the device and its NeoStiks into enough shops it’s likely to catch on too.

A home-grown rival?

The global tobacco companies can’t expect to have it all their own way, though. HnB devices are consumer electronics, and when it comes to developing and manufacturing these South Korea is one of the world’s giants. The country that’s home to companies like Samsung and LG isn’t likely to let imported electronics flood its home market, is it?

No, it’s not. Clearly impressed at the popularity of the new technology, one of South Korea’s own tobacco companies is already looking at moving into the market. KT&G (it stands for “Korea Tomorrow & Global”, but used to be “Korea Tobacco  Ginseng”) is the country’s largest tobacco manufacturer. It’s a major player locally, with 62% of South Korea’s cigarette market, and its Esse superslim brand is also popular in Russia and Eastern Europe.

Now KT&G want to release a HnB product to take on Glo and iQOS – and they’re not hanging around. According to the company they’ve been watching the heated tobacco trend since 2012 and want to have their own device on the market by the end of this year.

That’s quite an ambition. If they can pull it off, they’ll be in on the ground floor with PMI and BAT. The multinationals will have a bit of a head start, but not enough to let them build up real dominance, and that’s likely to be balanced by consumers’ familiarity with KT&G brands.

The real question is what will the product be like? Unfortunately KT&G haven’t released any details yet, but if they think they can get in on the shelves by the end of the year – even as a trial product – then its design must already be fairly advanced. A HnB device isn’t something you can just throw together; PMI have invested more than $3 billion in iQOS so far, and BAT can’t have spent much less on Glo.
iQOS is the latest version of a basic concept first trialled in 1998, as Accord, then redeveloped in 2007 as Heatbar.

 

So will it happen?

If KT&G are going to have any chance at all of getting a product on the market by December, it would need to be pretty much ready to go into production by this point. That means it would need to have been tested already, and probably tried by a good number of consumers to get their feedback on it. If this has been done, it’s been done unusually discreetly – we can’t find any details or images of a KT&G device anywhere.

Of course, South Korean companies are very good at keeping innovations quiet until they’re ready to start marketing them, so it’s very possible that KT&G really do have a product ready to launch over the next few months. If they do, it will be interesting to see how it compares to
iQOS, Glo and other existing devices. Hopefully we’ll know more about it – and whether it will be marketed outside South Korea – soon.

E-cigs don’t work everywhere – Heat not Burn does

I’m a freelance writer, and I love e-cigarettes. Since I switched to vaping my desk isn’t cluttered with smelly ashtrays anymore, and I don’t have to brush ash off my keyboard twice a day. I spend most of the day at my PC, so I can keep a charger on the desk for my batteries and there’s a nice long USB cable for pass-through mods. The top shelf in one side of the desk holds an assortment of e-liquids; in my job, vaping works perfectly.

On the other hand, before I became a writer I spent years in the British Army. Like many soldiers I smoked, and I remember a lot of early mornings happily puffing away in some cold, wet forest. No matter how soaked, frozen and miserable you get, a cigarette is a reliable way to inject some very welcome morale into your life.

The thing about cigarettes, of course, is that they couldn’t be simpler. You take one out the pack, stick the brown bit in your mouth and set fire to the other end. Unless you’ve let them get soaked, or you’ve sat on the packet and squashed them (a waterproof tobacco tin will avoid both these issues) they’re guaranteed to work.

War is hell – for e-cigs

But how is an e-cig going to cope with the hardships of a soldier’s life? All the liquid is probably going to leak out, turning the contents of your pocket into a slippery mess. The tank’s probably going to get broken the first time you trip over a stump in the darkness and fall flat on your face. The ability of most box mods to survive being soaked with rainwater is pretty dubious. Worst of all, your batteries aren’t going to last forever and there won’t be any USB ports in the tree you’re living under. E-cigarettes are great as long as you’re surrounded by civilisation, but they’re not going to work out in the field.

It isn’t just soldiers, either. What if your workplace is the deck of a trawler? The first wave that knocks you down, and leaves you flailing around in a pool of seawater and fish guts, is going to destroy every electronic device in your pockets. Let’s not even start thinking about rebuilding a coil in a cramped cabin that’s rolling through sixty degrees.

So it’s pretty obvious that there are some people who e-cigarettes just aren’t going to work for. But does that mean they’re doomed to a lifetime of smoking? Not so fast. There’s probably a heat not burn product that’s going to work just fine.

What’s the solution?

Last month I visited Philip Morris International’s research facility at Neuchatel in Switzerland, where they’re making the Heets that feed their iQOS device as well as working on the next generation of HnB technology. It was a very interesting visit – I’ve already discussed their latest research on safety – and left me feeling very optimistic about the future of heated tobacco products. There were some lively discussions, too, and during one of these I explained that I’d been a soldier for a long time and, based on my experiences, I didn’t think iQOS was going to be much use in the field. The PMI rep didn’t even blink. “We know,” she said. “That’s why we’re working on three other products.”

One of those products is the Mesh e-cigarette, which is already on the market. I have one, and it’s pretty good; the Mesh is an extremely simple and fairly sturdy gadget, and its disposable cartridges are more compact and probably a lot tougher than cigarettes, but if you’re doing hard work outdoors in bad weather it has the same drawbacks as any other e-cig; it isn’t very waterproof, and it needs charged a couple of times a day. Then there’s a completely different product in the development pipeline that isn’t HnB, but isn’t an e-cig either; it uses a chemical reaction to create a nicotine-containing vapour. The interesting thing about this is that it doesn’t need any batteries, so it might be a good solution for people who don’t have regular access to a charger; that depends on how robust it is, and I can’t comment on that because I haven’t seen one yet.

That’s three of PMI’s Smokefree nicotine products. The fourth one is a heat not burn product that uses the same concept as RJ Reynolds’s Revo. It’s a disposable item that contains a stick of processed tobacco and a charcoal pellet that provides the heat. All you have to do is light the pellet and puff away.

Revo isn’t really a new product; it’s basically a rebranded version of the 1990s Eclipse, which was a complete flop. Reynolds relaunched it under the new name because they decided the market had moved enough to make it viable this time around, but it’s still basically the same thing. I’m not very familiar with it but I do have some doubts about how effective it is.

So far, at least, those doubts don’t apply to the PMI product, which the company are currently calling Platform 2. It works on the same principle as the Revo, but it’s a completely new design. That gives PMI a chance to iron out any bugs, and hopefully come up with something that delivers a consistent vape with no risk of accidentally burning the tobacco.

Keeping it simple

The benefits of this sort of design are obvious. If you can manage to smoke, you can use a HnB product like Revo or Platform 2. It works exactly like a cigarette; you just have to take it out the pack, put it in your mouth and light it. There’s nothing fiddly to play with, it doesn’t need electricity and it’s no more vulnerable to the weather than a cigarette. In fact it’s probably less likely to get damaged by water; Revo has a metal foil tube to hold the tobacco, which is a lot more waterproof than cigarette paper.

A lot of smokers have switched to vaping – probably over ten million by now – but it’s not going to work for everyone. Improved technology will eventually increase battery life and make the hardware easier to use and more robust, but it’s not likely e-cigs will ever be as simple as a traditional cigarette. Heat not burn has the potential to solve that problem, because the basic principle – get some tobacco and heat it – is a lot more flexible. Inside a few years there will be HnB products that anyone can use, no matter how tough their job is.

 

Heat Not Burn Safety Update

Over the last year we’ve seen a lot of progress for heat not burn products, with the iQOS now available in several countries and a few new devices set to be released soon. The market looks like it could be on the brink of some serious growth, and within a few years HnB could have made as big a dent in smoking rates as e-cigarettes already have.

There’s one thing still missing, though. If heated tobacco products are really going to grab a sizable percentage of the cigarette market it’s important that their makers can show they’re safer than smoking. As we’ve mentioned before, common sense tells us they pretty much have to be a lot safer, because the tobacco isn’t being burned, but there’s a distinct lack of actual data. Isn’t anyone doing the research on this? It turns out the answer is yes.

Of course, you won’t see this research appearing in the medical journals just yet, because it’s actually being carried out on behalf of the tobacco industry. Philip Morris International have invested more time and money in HnB than anyone else, and a lot of that has gone towards looking into how much risk can be removed by switching from lit to heated tobacco. Some world-class laboratories have been asked to investigate how HnB is working and what that means in terms of health effects. Last week Heat not Burn UK got a chance to visit the Cube, PMI’s European research HQ at Neuchatel in Switzerland, to find out what’s going on.

How hot is too hot?

By now everybody knows that smoking-related diseases aren’t caused by tobacco; it’s the combustion process that creates the worst toxins and cancer-causing substances. Tobacco-free herbal cigarettes aren’t any better for you than Benson & Hedges, because you’re still inhaling burning plants. However, PMI have found out that making a safe HnB product isn’t as simple as not setting fire to the tobacco.

The tip of a lit cigarette, between puffs, is at between 600°C and 800°C; when you take a drag on it this rises to over 900°C. That’s the sort of temperature tobacco burns at. However, at much lower temperatures it goes through a process called pyrolysis, where it’s being broken down by heat but not actually burning. Pyrolysis starts at around 350°C, much lower than combustion temperatures – and pyrolyzing tobacco still gives off a lot of nasty chemicals. Not as much as burning it, of course, but probably still more than you really want to be inhaling.

So the trick to safe HnB is to heat the tobacco to just below the point where pyrolysis begins. If you were wondering why iQOS heats its sticks to 350°C when tobacco doesn’t start burning until hundreds of degrees above this temperature, now you know. PMI have opted for the highest safe temperature, where there’s little or no pyrolysis going on but the tobacco is still hot enough to generate a decent vapour. Because HnB products like iQOS, Glo and PAX 2 are electronically controlled it’s easy to get them to produce a constant temperature and avoid pyrolyzing or burning the tobacco.

Tracking the toxins

Obviously the big question is, what effect does HnB have on the levels of chemicals you’re inhaling? It’s unrealistic to insist on zero chemicals, because many of the toxins in cigarette smoke are very common substances. For example, smoke contains high levels of formaldehyde – but human bodies contain formaldehyde, too. Our metabolism produces it, and there are detectable levels of it in exhaled breath. What we’re looking for are levels that might not be zero, but are much lower than you’d get from a cigarette.

To test this, PMI analysed the smoke from a reference cigarette – this is a standardised cigarette used for lab testing – then compared it with the vapour from their two HnB products. One of these is iQOS; the other, known as Platform 2, hasn’t been released yet but works in a different way. What they found was that for every chemical they tested, levels were dramatically reduced in both HnB products. The highest levels were for ammonia, with iQOS having about half the level of a cigarette and Platform 2 around 40%. Is that enough to worry about? No; even cigarette smoke doesn’t have anywhere near enough ammonia to be an issue. For the other chemicals they tested levels were reduced by at least 80%, and in most cases 90 to 95%. Overall it looks like HnB eliminates more than 90% of the harmful chemicals found in cigarette smoke.

One impressive point about PMI’s research is that they’ve been extremely thorough. Different agencies have different lists of chemicals in smoke that concern them. For example the FDA have a list of 28 different substances; the International Agency for Research on Cancer’s list has fifteen. To be on the safe side, Philip Morris have simply combined everyone else’s lists; they test for fifty-eight different chemicals – far more than anyone else does.

Attention to detail

PMI aren’t just measuring what’s in the vapour; they’re also testing smokers who’ve switched to their HnB products to see how they compare with people who’ve either quit entirely or continued to smoke. What they’re doing here is looking to see if switchers’ blood chemistry is more like a smoker or a quitter. For every chemical they’ve tested – including carbon monoxide, benzene and acrolein – HnB users either have identical levels to smokers who’ve quit entirely or (for acrolein) the level is slightly higher than a quitter but much lower than a smoker.

At Heat not Burn UK we might not be scientists, but we do know how science is supposed to be done. The research that’s being carried out on the health effects of HnB is very good science. It’s extremely thorough and detailed. The actual analysis is being carried out by independent labs, which should deal with any accusations of bias. PMI are being completely open about the experimental methods, so anybody who has doubts can replicate the research themselves.

Why so modest?

That leaves one question: With all this research to back them up, why aren’t PMI shouting from the rooftops about how safe HnB really is? Most likely that’s down to an understandable wariness of being sued. If they say that iQOS is 90% safer than smoking, and then at some point in the future evidence shows it’s only 89.9% safer, how long is it going to be until swarms of Californian lawyers descend on them with a fistful of class action suits? Not long, probably.

So, for now, they’re playing a cautious game. The data is there, and steadily growing. Sooner or later it will be presented to some government agency, probably the FDA, and they’ll confirm that these products are much safer than smoking. That’s when the manufacturers will start publicising it. Until then we’re just going to have to rely on common sense.

iQos Review – How good is Heat not Burn anyway?

Heat not Burn products haven’t gone mainstream yet, but that moment is steadily approaching. Several products are now going through market trials and the most promising of these is Philip Morris’s iQOS system. We’ve looked at this before, but because it’s only on sale in a few countries it’s been surprisingly difficult to get hold of one to actually try it out. However Heat not Burn UK don’t give up easily, and at last month’s Global Forum on Nicotine in Warsaw the elusive iQOS was finally run to ground and given a thorough trial.

The iQOS is the latest incarnation of PMI’s “HeatStick” concept. The basic idea is that a special short cigarette is inserted into one end of a small electronic device. The device heats the tobacco enough to release vapour – it runs at about 350°C – and you then inhale it by simply taking a puff. Previous versions didn’t do very well in testing but the iQOS has been given a big boost by modern batteries and USB charging systems; the technology has finally caught up with PMI’s ambitions for the concept.

It’s very clear that PMI have put a lot of thought into the design of the iQOS. The device itself is a very sleek piece of gear; smaller and lighter than an eGo-style e-cig, and pleasantly free of things that need to be adjusted, fiddled with and pressed. The vaping industry is working hard to open a gap between itself and tobacco; you could never mistake a modern e-cig for a traditional cigarette, and the user experience is very different too. That’s definitely not the case with the iQOS. This product is aimed squarely at smokers, and it seems that the number one priority was to keep it as close as possible to using an actual cigarette. There’s just one button to turn it on, and an LED to let you know when it’s warmed up. It also feels like a very high quality unit. The body is solid, and has a soft, comfortable rubberised finish.

HeatSticks – like a cigarette, but different

The real heart of the iQOS is the HeatSticks it’s fed with. These look like short cigarettes, complete with filter, and come in packs of 20. If you’re used to buying a pack of cigs every day you won’t notice much difference with HeatSticks, apart from them being a bit cheaper. Handling one, it feels exactly like a cigarette – so much that you’re tempted to just stick it in your mouth and light it. Don’t do this; it’s kind of missing the point, and they won’t burn properly anyway.

Instead, what you do is insert the HeatStick into the hole at one end of the iQOS. This looks like it could be quite fiddly, but it turned out to be simple. Once in it’s held snugly in place, so you don’t have to worry about it falling out into your lap either. Then you just turn the device on and wait for it to heat up to operating temperature. This takes under a minute and you don’t have to guess when it’s ready. As soon as you press the button to turn it on a green LED starts blinking; when the device is ready to go it stops flashing and glows steadily. After that, all you have to do is puff away.

Does it work?

So the big question is, what’s it like to use? Can the iQOS really replace traditional cigarettes? That boils down to whether the vapour it produces has enough flavour, throat hit and nicotine, as well as the quantity of the vapour itself. The answer, you’ll be glad to hear, is yes – it works.

It does need to be said that the test conditions weren’t perfect. So far there are four HeatStick options available. You can choose from either traditional tobacco or menthol, and they both come in either strong or mild. I never liked menthol cigarettes and preferred lethal, high-tar blends like West or Marlboro Red, so of course the only HeatSticks available to try were mild menthols. Obviously the experience of vaping the iQOS didn’t match up to the lung-blackening pollution belched out by my old favourites, but then with these sticks it was never going to. What I can say is that I smoked mild menthol cigarettes more than a few times when there was nothing else available, and the iQOS did match that experience very well indeed. Swap the minty milds for strong regular tobacco sticks and I think you’d get a suitably satisfying inhale from it. The vapour is rich and warm, but doesn’t leave a lingering tobacco smell.

Each HeatStick is good for about a dozen puffs or slightly more, so it’s roughly equivalent to a normal cigarette. You could probably take a few puffs and power the device down, then finish it later, but I’m not sure what effect that would have on the flavour. I found that, unlike an e-cig, it worked fine when used just like cigarettes; load a stick, fire it up and vape the whole thing.

What also deserves a mention is how familiar the experience is. Yes, you need to load the stick and wait for it to warm up, and the device is larger and heavier than a traditional cigarette. It’s not that much larger and heavier though – compared to any of my current e-cigs it’s a real featherweight. You can hold it just like a cigarette with no problems at all. The filter is also exactly the same as you’re used to, so there’s no need to adjust to a metal or hard plastic drip tip; that took me a while to get used to when I started vaping and it’s an issue with some HnB products, like the otherwise very popular Pax 2.

iQOS has another advantage over the Pax 2 as well. There’s no need to scrape cooked tobacco out of it when you reload; just pull the used HeatStick out and drop it in the ashtray. There’s no ash or mess; everything stays self-contained.

Everything about the iQOS feels well put together. The device itself comes in a neat little charging case, so you can keep its internal battery topped up while you’re on the go. The case itself can be recharged with the usual micro USB cable.

So what’s the verdict? I have to say I was very impressed with this. It’s the closest thing I’ve ever found to the experience of actually smoking, so if you’ve tried e-cigarettes and found they didn’t really work for you this could be just what you’ve been waiting for. It’s simple, efficient and pretty much fool proof. Right now the iQOS is only available in Japan, Switzerland and Italy, but when it rolls out globally it deserves to win a lot of converts.

If you’re not in one of those countries Amazon has an excellent selection of iQos products for sale.