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FDA approves iQOS at last

FDA approves IQOS

If you’re a regular reader of this site – and you should be – you’re probably aware that if you live in the USA, and want access to the latest in effective Heat not Burn devices, you’re basically stuffed. Philip Morris submitted a Pre Market Tobacco Authorization for the iQOS in 2017, but for the last two years they’ve basically been sitting on it. Well, at last there’s some good news; the FDA approves IQOS and American smokers should finally be able to buy the world’s leading HnB system.

Why so slow?

You might wonder why it’s taken the USA so long to approve a device that even the notoriously risk-averse European Union pretty much waved through the regulatory process. The answer is depressingly simple – the USA has some of the world’s craziest opponents of tobacco harm reduction. See here, here and here for previous blog posts. That probably shouldn’t be a surprise, really. I like the USA and enjoy spending time there. I admire many things about its can-do, freedom-loving, independent culture. Many of my best friends are American. But wow, does the USA have a problem with recreational drugs or what?

Under political pressure, the US prison system regularly lets rapists and murderers out of jail early to free up cells for people who were caught with a couple of spliffs in their car. California has been a world leader in persecuting smokers for years – it’s not just illegal to smoke in bars there, like it is in most countries now; it’s illegal to smoke within 25 feet of a pub doorway! Worst of all, the USA is the only country outside the Persian Gulf that’s ever tried to completely ban alcohol. It gets crazier; in the 1920s the US government deliberately killed thousands of its own people by spiking industrial ethanol with poison, just in case someone made a cocktail with it. Despite that, and the rise of organised crime syndicates that made a fortune running whisky in from Canada, a significant percentage of the US population still actually believe that Prohibition was a good idea!

So if you’re selling any kind of recreational drug in the USA, even if it’s just a glass of beer or a bottle of e-liquid, you can expect to face a pretty spectacular level of self-righteous insanity from the Puritan mob. Selling a product that was actually developed specifically to improve public health by reducing smoking? It doesn’t matter; if it contains nicotine and it’s enjoyable to use, a lot of people are going to hate you for it.

Vapers are already depressingly familiar with the name Stanton Glantz. This bloated imbecile is a “professor or medicine” at the University of California, San Francisco, despite all his actual degrees being in aeronautical engineering. A fanatical anti-smoker, Glantz has also made a fool of himself by claiming that mobile phones cause brain damage. He absolutely hates e-cigs, of course. So can we guess what he thinks about HnB? Yes, of course we can. The FDA approves IQOS and he’s not happy about it at all.

Glantzing at the facts

In a hideously biased post on his UCSF blog, Glantz claimed that PMI are hiding data that proves iQOS is as dangerous as cigarettes “in plain sight”. The data is indeed in plain sight – even long-time critics of the tobacco industry admit that PMI are being very open about iQOS; it just doesn’t say what Glantz thinks it does.

The fat professor’s first mistake is to repeat claims he first made about e-cigarettes – that they release “ultrafine particles” which cause heart and lung disease. The problem is that the research he bases these claims on was about solid particles in cigarette smoke and diesel exhaust; it has no relevance to the liquid droplets in e-cig or iQOS vapour.

Not content with this display of ignorance, Glantz then performed an indecent act against the whole field of toxicology by claiming “ Fewer toxic chemicals… do not necessarily translate into lower harm.” Well yes Stan, that’s exactly what they translate into! The first principle of toxicology is “the dose makes the poison”. If you have fewer toxic chemicals at lower doses – and Glantz is tacitly admitting that’s what iQOS delivers – you get less harm. Basically, you have to be a fool not to recognise this.

Missing the point

Another perpetual anti-harm reduction pest is the Campaign for Tobacco-Free Kids, led by sub-Glantzian idiot Mitch Myers. CTFK has been a determined opponent of e-cigs for years even though they don’t actually contain any tobacco, and they don’t like Heat not Burn much either.

This is because, as their name suggests, they’re spectacularly missing the point. Tobacco isn’t a problem; tobacco smoke is a problem, but tobacco itself isn’t. Swedish snus, for example, is virtually pure tobacco and it’s about as healthy as quinoa. It’s true that some forms of chewing tobacco increase your risk of cancer, but that’s because of the way they’re processed; it’s not because they’re tobacco.

iQOS might be slightly less safe than Swedish snus, but it still eliminates the actual problem, which is inhaling the smoke produced by burning vegetable matter. Note, again, that this doesn’t have a lot to do with tobacco; inhaling the smoke from burning kale isn’t going to be any healthier than puffing on a Marlboro. It’s the fact you’re inhaling smoke that’s bad for you and iQOS doesn’t produce any smoke. Tobacco Free Kids don’t care – because Tobacco Free Kids are idiots.

Back on track

Anyway that was a nice little digression about some of my least favourite people, but actually it was pretty relevant. One reason the FDA have taken so long to evaluate iQOS is that they’ve been constantly pestered by Glantz, CTFK and a few other lunatics, and have had to spend time evaluating their outlandish claims. PMI knew this was going to happen, though, so they didn’t just send the FDA an iQOS and a few packs of HEETs; they sent them a ton of evidence as well. In fact they sent enough evidence that if you printed it out on A4 it would make a stack about 700 feet high – around two million pages of supporting documents.

Happily, it seems to have been enough; iQOS has now been granted a Pre Market Tobacco Authorization and can be legally sold in the USA. PMI are still waiting on a Modified Risk Tobacco Product endorsement, which will let them say in their advertising that iQOS is a safer alternative to smoking, but the PMTA was the big hurdle. So far the only reduced risk tobacco products to get one are a few snus flavours from Swedish Match. No e-cig maker has even tried, and the cost of preparing the FDA’s paperwork is so high only a few are even capable of it.

Anti-tobacco groups are already yelping about iQOS getting a PMTA; the Truth Initiative – which is directly funded by cigarette sales, by the way – is tweeting that the PMTA doesn’t mean that the FDA approves IQOS. Sorry; that’s exactly what it means. As we’ve seen over and over again with e-cigs, though, these fanatics won’t quit banging on about Heat not Burn.

Right now they’re behind the curve, though. The FDA approves IQOS for sale in the USA, and that isn’t just good news in its own right – it sets a precedent for other devices to get a PMTA as well. As long as they work similarly to iQOS the FDA now has an already—approved device to compare them to, so we can expect to see more HnB systems hitting the US market in the fairly near future. There’s a hard fight still ahead for Heat not Burn advocates, but we’ve won this battle.

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