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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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Will iQOS get FDA approval in the United States?

This could be absolutely massive if Philip Morris’ iQOS is granted FDA approval as a modified risk tobacco product later this year, or early next year when it is announced.

So what are your thoughts on this? Vote now in our poll!

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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.