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FDA vote is a setback – but not a disaster – for iQOS

Yesterday was an important day for PMI’s iQOS device, and for the whole future of Heat not Burn in the USA. Following a long bureaucratic process an FDA advisory panel discussed, then voted on, PMI’s claim that iQOS is a Modified Risk Tobacco Product (MRTP), a decision that could decide whether or not it goes on sale in the United States. It went better than it might have done, but unfortunately the results were still disappointing.

PMI submitted their MRTP application in December 2016; the reason it’s taken so long to come to a vote is that the application came to over a million pages of data. Achieving MRTP status would be a significant advantage for iQOS; it would allow PMI to market the product as less harmful than cigarettes, and to alter the warning labels on packaging to make clear that it’s a safer alternative. The final decision on granting MRTP status will be made by senior FDA management, probably some time in the next few months – and, while they’re free to ignore the recommendations of the advisory panel, they rarely do.

What was decided?

Yesterday’s panel voted on three issues. Firstly, have PMI proven that switching to iQOS will cut the risk of developing a smoking related disease? Secondly, is using iQOS healthier than continuing to smoke? Finally, does switching to iQOS reduce exposure to harmful and potentially harmful chemicals? In a slightly confusing mixed decision the panel rejected the first two claims, but voted strongly in favour of the third.

On the first question, reducing the risk of smoking-related disease, eight of the panel’s nine members voted that PMI hadn’t provided evidence for this; the last member abstained. The main issue seems to be that most of PMI’s clinical testing was carried out on rats, and the panel want to see results from human tests. To be blunt about it, this is not very reasonable. iQOS is a relatively new product, so there hasn’t been time for long-term trials on humans.

However, when it comes to the chemicals involved in iQOS vapour, this isn’t exactly a leap into the scientific unknown. All the potentially harmful substances found in iQOS vapour are also found, at much higher levels, in cigarette smoke – and of course the most harmful ingredients of smoke, carbon monoxide and tar, aren’t found at all.

On its own the panel’s rejection of this claim isn’t too surprising, although it’s certainly not justifiable. The FDA has a huge institutional hostility to tobacco products; even Swedish snus, which appears to pose no health risks at all, hasn’t been able to make its way through the MRTP process yet. However, put the decision into context with the FDA’s finding that PMI are right about iQOS users being exposed to fewer, and less abundant, toxins and it makes no sense at all. After all, it’s exposure to these chemicals that causes smoking-related disease, so if the chemicals are reduced or eliminated the risk of disease will fall. That’s basic toxicology – “The dose makes the poison”. This isn’t exactly a radical idea either; it’s been universally accepted since Paracelsus wrote it in 1538.

Exactly the same applies to the panel’s decision that using iQOS hasn’t been proven healthier than continuing to smoke. If they accept that the vapour is far less toxic than cigarette smoke – and they did, by eight votes to one – then why not also accept that inhaling vapour is much less risky than inhaling smoke?

So what’s going on?

On the face of it the panel rejecting two of PMI’s claims, but accepting a third that backs up the first two, doesn’t make any sense. After all the reduction in harmful chemicals is the whole point of iQOS, and the reason behind it is to reduce risks.

It does start to make sense if you look at it from an ideological, rather than a scientific, perspective. The panel can’t really argue with the fact that iQOS vapour has a fraction of the problematic chemicals found in tobacco smoke; that’s hard data, collected by independent labs and published in peer-reviewed journals. It cannot be disputed. Denying it is equivalent to Flat Earthism, so it’s actually impressive that only one member of the panel went down that road.

On the other hand, the claims about reduced risks to health are tentative. They’re based on the best analysis of the data, but – hypothetically, at least – they could be wrong. They aren’t, of course; that would require what tobacco control expert Clive Bates called “a novel and implausible theory of the human body”. But, nevertheless, the panel seem to have seized the chance to show how much they hate the tobacco industry.

Now what?

As annoying as it is, the panel’s conclusions aren’t the end of the road for iQOS. When the FDA makes its final decision there are still two open questions. One is whether or not to grant MRTP status anyway, despite the vote. Recommendations from the advisory panel carry a lot of weight, but the agency can disregard them. It’s definitely possible that under director Scott Gottlieb, who at least on paper is committed to harm reduction, they’ll decide to grant it.

Even if they don’t award MRTP, the FDA can decide to let iQOS go on sale anyway. In that scenario the packaging would have to carry standard health warnings and PMI wouldn’t be able to market it as a safer option, but word would get round anyway and we could expect to see a lot of smokers make the switch. iQOS is demolishing the cigarette market in Japan at an impressive rate and there’s no reason why it couldn’t do the same in the USA; it would be hard for even the USA to object to that.

The worst case scenario is that Gottlieb decides not to allow iQOS to be sold in the USA. That seems unlikely, but if it does happen the result is likely to be disastrous for HnB in America. PMI have spent a vast amount of money preparing this application, and if it’s rejected on openly ideological grounds it’s hard to see other companies lining up to apply. There’s a lot of lives hanging on the FA’s decision, so let’s hope that unlike their advisory panel they get it right.

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iBuddy i1 Unboxing Video

iBuddy

Here at Heat Not Burn UK as we have said before we are very interested in all kinds of heat not burn products from all around the world. Well we have managed to find a heated tobacco product from China that is called the iBuddy i1, and it is an interesting bit of kit.

It is supposed to come with some “iBuddy sticks” that are specially designed for the unit but so far we haven’t been able to find any! Now as luck would have it the tobacco sticks from the iQOS actually fit into the iBuddy. What are the odds of that happening? In truth we have a sneaking feeling that it was designed for the HEETS that go with the PMI iQOS, we would like to be proved wrong so if any of our readers have actually seen any then please let us know.

Our effervescent staff member Fergus has managed to do a excellent unboxing video where we will show you what the iBuddy i1 is all about and what exactly comes with the kit. How will it measure up to the iQOS? Wait and see in our next video in a couple of weeks time.

Video not showing? Watch it directly on our Youtube Channel.

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PMI want to give up cigarettes – but not everyone’s happy

In the last post we talked about New Year resolutions and how switching to heated tobacco might be one of yours. That turned out to be quite prophetic, because somebody else made a resolution that features HnB products, and they didn’t exactly keep it quiet either. That somebody was Philip Morris, the world’s largest and most successful tobacco company, and they announced their resolution with a series of full-page ads in major newspapers.

On the 2nd of January, a large PMI advert appeared in three of the UK’s best-selling papers, The Times, The Sun and The Daily Mirror. To say it was attention-grabbing doesn’t really do it justice. The banner headline read:

OUR NEW YEAR’S RESOLUTION

WE’RE TRYING TO GIVE UP CIGARETTES

Just to make sure everyone got the message there was a big, bold PMI logo at the bottom of the ad, which certainly must have piqued a lot of people’s interest. After all, PMI are pretty much famous for one thing, and that thing is selling cigarettes. So why on Earth would they want to give them up?

If you read on, you’ll find out. The next line says “Philip Morris is known for cigarettes. Every year, many smokers give them up. Now it’s our turn.” That doesn’t leave a lot of room for doubt – PMI are saying, very clearly, that they want to stop selling cigarettes.

Predictably, this has sparked a lot of comments. Many people are very supportive – we at Heat not Burn UK are, for example. So are most libertarians, many vaping advocates and at least one major tobacco control group, the Foundation for a Smoke-Free World.

Equally predictably, not everyone is so happy. A whole alphabet of agencies, pressure groups and nanny state advocates are jumping up and down, squeaking in outrage. How very dare Philip Morris say they’re going to stop selling cigarettes! Isn’t it awful that they’re allowed to say such horrible things?

Well, maybe not. Let’s look at exactly what PMI are proposing, seeing as they helpfully listed it all in their adverts:

  • Launch a new website, with an associated marketing campaign, to give smokers information on how to quit and what safer alternatives are available.
  • Offer support to smoking cessation services in areas where smoking rates are highest.
  • Put a card with information on how to quit or switch to a safer product in packs of cigarettes.
  • Make more safe alternatives available to British smokers.

Of course PMI have already spent more than £2.5 billion on the last of these, and the first products are on sale in the UK right now – iQOS and the Mesh e-cigarette. Over the next year or two more will follow, including at least one more heated tobacco product and a completely different one that uses chemical reactions to create a nicotine mist.

So what’s the problem? Why are people like Deborah Arnott, the perpetually outraged CEO of Action on Smoking and Health, so angry that PMI are willing to spend a lot of money helping smokers to quit? Well, that’s where it gets complicated. There seem to be two main themes at work here, so let’s look at those.

PMI don’t mean it!

The first objection is that Philip Morris don’t really mean it. After all, if they want to stop selling cigarettes they could just stop, couldn’t they? In fact tobacco control come out with this argument every time a tobacco company does anything related to harm reduction or alternative products – “Why don’t you just stop making cigarettes, then?”

Well, mostly because it’s not that simple. Last Tuesday, when the PMI advert appeared, the BBC asked a company spokesman the same question, and it got an obvious answer: Basically, “Because if we stopped selling cigarettes tomorrow, smokers would just buy them from someone else.”

I suppose you could argue that if all the tobacco companies stopped selling cigarettes there would be nobody else to buy them from, but let’s be realistic here: There’s a large, organised criminal industry making counterfeit cigarettes already, despite the tobacco companies selling over five trillion real ones every year.

Just imagine what would happen if the legitimate supply dried up. Does anyone seriously think all of the world’s one billion smokers would just quit? Not a chance; most of them would start buying on the black market. The people who run that black market would become, overnight, the richest and most powerful criminals in the history of the world. Cocaine, heroin, even America’s Prohibition-era bootleggers would pale into insignificance.

There’s another point, too. Tobacco companies have a legal duty to their shareholders to make a profit, so if they all trashed their businesses tomorrow they’d go to jail. Meanwhile the pension funds who are the biggest owners of tobacco shares would collapse, leaving millions of pensioners in poverty. The economic damage alone could trigger another global recession.

So, for a couple of reasons, PMI can’t just stop making cigarettes. It’s only going to work once the majority of smokers have either quit or switched to reduced risk products, like Heat not Burn or e-cigarettes. Philip Morris have already spent a lot of time and money encouraging that, and now they’re offering to spend more.

 

It’s against the rules!

Arnott also claims that PMI’s second proposal – offering support to stop smoking services – is illegal. The basis for this claim is that under Article 5.3 of the WHO’s tobacco control treaty, governments aren’t allowed to accept donations from the tobacco industry. This obviously looks like a problem, except for one tiny detail: Somebody is lying here, and it isn’t PMI.

Article 5.3 says no such thing, and Deborah Arnott knows that. All the article actually says is that any interaction between government and the tobacco industry must be transparent, so as long as PMI are supporting stop-smoking services openly there’s no problem. I’ve met Arnott more than once and it would be safe to say she is not my favourite person (I’m not hers, either), but it’s still unpleasant to have to state that she is being completely dishonest here.

Arnott says that, instead of donating to stop smoking services, tobacco companies should be forced to give the government more of their profits. It’s not hard to guess why: ASH has lost a significant amount of its government funding in the last year, and its response has been to push for a Tobacco Levy. This would be an extra tax on the industry, with a big chunk of the proceeds going to – you guessed it! – ASH.

Back to reality

The truth is, it’s not hard to understand why PMI are serious about moving to safer products. Why wouldn’t they be? There’s obviously a demand for safer ways to use nicotine – just look at the way vaping has taken off in the UK, and how fast iQOS is growing in Japan. If PMI don’t sell those products they’ll lose out to companies that do, and if they are selling them, why not work to steer customers towards them and away from the more dangerous ones?

What it comes down to is that smoking isn’t good for you, and everyone knows that. The tobacco companies know it, although they denied it once – but that was decades ago and the people who did it are all long gone. Arnott knows it; after all, she’s made a lot of money telling people. You know it, too; that’s why you’re on this site reading about safer products.

Heated tobacco, and other reduced-risk products like e-cigarettes, have turned the world of tobacco control upside down. Now we have Philip Morris offering to spend their own money to help people quit smoking, while the old guard like Deborah Arnott shout abuse from the sidelines because it’s not all about them anymore. At Heat not Burn UK we’re just interested in safer alternatives to smoking, and we’re on the side of anyone that makes them available. So well done on your New Year’s resolution, PMI – we’re sure you’ll do all you can to make it happen.