Analysis from ECITA’s Chief Scientific Officer, Tom Pruen
The World Health Organisation recently gave a presentation at the EU parliament, at a workshop intended to educate MEPs about electronic cigarettes. Sadly, the WHO demonstrated that they themselves are woefully ill-informed on this subject – not a good position from which to attempt to educate others.
Here is part of their ‘presentation’ – and what is wrong with it. (Please note that there are quite a few slides before this – but they are pretty much devoid of information; slides are skipped throughout this blog where either I have no comment, or there is no content worth reading. The original can be found here, if you want the full version.)
And so it starts: a mixture of common knowledge, misinformation and outright speculation. Since e-cigs are available with or without nicotine, and in a variety of flavours, they don’t always contain anything derived from tobacco. The idea of flavours appealing to adolescents is often raised as a scary prospect, but not only is there little more than speculation to support such scaremongering, there is research which flatly contradicts it – including some conducted in the UK by Action on Smoking and Health.
Proof (which came as a bit of a surprise to me) that the WHO actually knows what an electronic cigarette is (more or less). Having demonstrated their ability to Google “electronic cigarette” and find a pretty picture, as well as establish that there is no smoke, why, later in the presentation, does the WHO bleat about electronic cigarettes being used to “defy smoke-free ordinances“. Where is the defiance in using a smoke-free product in a smoke-free area?
Ah, yes: carcinogens… at trace levels which are unlikely to have an effect, and similar to those found in medicinal, licensed nicotine products; and, of course, DEG – notoriously found in one single sample tested in 2009 by the FDA. Less well-known is that it has never been found in any of the hundreds of samples ECITA members have tested.
As for the alleged danger of PG, if the “potentially toxic” nature of propylene glycol is a cause for concern, why is it an approved EU food additive (E1520), Generally Regarded As Safe (GRAS) by the US FDA, and used in a wide range of everyday consumer and pharmaceutical products? ‘Tobacco-specific nitrosamines’ (TSNAs) are the same ‘known carcinogens’ alluded to in the first bullet point; naming them doesn’t make them any more dangerous. (Mind you, if we refer to water as Dihydrogen Monoxide, we can make it sound a whole lot more dangerous.)
Considering the list of red alert “toxins” being released into the air, and “averaging around 20% of what the conventional cigarette produces”: either this is a deliberate lie, or the author is unable to perform basic mathematical calculations. Ignoring the rather laughable ‘average’ in favour of some direct comparisons, and using the data from the study referenced:
- Acetic acid (most commonly found as vinegar) was present at an average of 13 micrograms per meter cubed (µg/m3) for e-cig vapour, against 68µg/m3 for tobacco smoke;
- Isoprene (which is a naturally occurring by-product of human metabolism) was found in e-cig vapour at an average level of 8µg/m3, against 135µg/m3 for tobacco smoke; (to demonstrate the utter absurdity of suggesting this is a dangerous or frightening level, the blank sample also contained 8µg/m3);
- Formaldehyde (which is produced in small amounts by most living organisms as part of normal metabolism; according to Health Canada: “No effects were found in children exposed to 10-29µg/m3 and 30 to 49µg/m3 formaldehyde” and: “The risk of cancer associated with formaldehyde levels sufficiently low to prevent irritation and inflammatory responses appears therefore to be negligible”) was found in e-cig vapour at 12µg/m3 against 86µg/m3 for tobacco smoke;
- Acetaldehyde (which “occurs naturally in certain foods, such as ripe fruits and coffee, and in cigarette smoke. Green plants produce acetaldehyde as they break down food”, according to the Environmental Protection Agency) was 2µg/m3 in e-cig vapour against 119µg/m3 in tobacco smoke.
Most of the toxicants found at significant levels in smoke were at less than 1 microgram in e-cig vapour, making it difficult to see how it is possible to arrive at a 20% average, even allowing for an incentivised interpretation of the facts.
The FDA has been told – in no uncertain terms, on more than one occasion – by the US courts that electronic cigarettes cannot “meet the definition of a combination drug-device product”, making this either terrible research or a lie. (It is true that this was the way the FDA was thinking in 2009, but rather a lot has changed in the intervening four years.)
Quality control is required – of that there is no doubt, and it forms an important part of the ECITA standard. It is, however, nonsense to suggest that users of electronic cigarettes are likely to poison themselves; there has been no evidence of this happening in the last 4 years. In fact, users of electronic cigarettes are no more likely to poison themselves than smokers. The ability of nicotine users to self-titrate their nicotine levels is well acknowledged. As such, a big scary table of nicotine overdose symptoms is of little value, except possibly to try and engender fear.
Let’s look at these bullet points in order:
As non-medicinal products, clinical studies proving efficacy are rather less relevant than their appeal to smokers – something which consumer engagement in the TPD process would seem to demonstrate very well.
If the consumers of these products don’t believe these products are capable of “cigarette mimicking sensory characteristics”, why are they so upset by the idea of a de facto ban? Why is there so much growth in the market if this isn’t the case?
Given that this presentation has already referenced studies demonstrating the “emissions of ENDS”, and others that they neglected to mention also exist, this is simply a lie.
Finally! A valid concern! There is indeed a potential risk of poisoning from the refill liquid. That is why the EU has such robust legislation for the sale, labelling and packaging of potentially dangerous chemical products. The success of this existing regulation can be seen in the lack of poisonings observed in the 4+ years that electronic cigarettes have been widely available.
Also – nice plug for Njoy! It must be nice to see your brand displayed so prominently by the WHO.
And again, let’s examine this drivel in order:
If the use of e-cigs among smokers becomes normalised, it can only serve to further demonstrate the negative effects of continuing to smoke, and emphasise the need to reduce the harm caused by smoking. Who is going to want to go outside with their cancer stick, when they can stay indoors and vape?
The long term ‘success’ rate of NRT, as established by several meta-analyses, is well under 10%, so why is this only a concern for a non-medicinal product that makes no claim to prevent relapse or cure nicotine addiction?
While the use of electronic cigarettes in places where smoking is banned could be considered impolite, given that they do not generate the second hand smoke which smoking bans are intended to prevent, that is all it could be – impolite. Since, as has already been said, several studies have looked at the emissions of electronic cigarettes for precisely this reason, there is knowledge on this subject, and based on that knowledge the levels of carcinogens are not significant.
This slide is a blend of prejudice and stupidity (or at least an inability to research that is indistinguishable from stupidity). The number of smokers abandoning tobacco cigarettes in favour of e-cigs has indeed grown, and a great many of them are very thankful for it. This is a good thing!
Since e-cigs or ‘ENDS’ are not tobacco products and are demonstrably less harmful than smoking, it is hard to see why this would be an issue. If a less harmful alternative to tobacco cigarettes can be promoted to smokers while the far more harmful tobacco cannot, the gains to public health should be significant.
“Australia – ENDS avoid plain packaging laws”; the plain packaging laws introduced for tobacco products; the ones introduced to try to persuade smokers to stop inhaling smoke? So electronic cigarettes avoiding these restrictions on products in an entirely different classification is a problem because …? As for attempting to relate electronic cigarettes to the significant problems in the past of cigarette advertising glamourising smoking, the WHO appears to have missed the very real and visible effect – all over the globe – of NOT smoking being glamourised, as more and more people switch away from harmful smoking, and switch to vaping.
The statement about the regulation in the UK is complete and total rubbish. Nicotine solutions of up to 7.5% may be supplied in the UK, and e-cigs are regulated by Trading Standards under the GPSD et al. Medicines regulation applies if a medicinal claim is made, but this is true in all Member State jurisdictions, since this is enshrined in EU law.
The characteristics of cigarettes are very well understood, and the use of them has continued despite the best efforts of national and EU bodies. Providing smokers with a less harmful alternative can only be a good thing.
Placing a high regulatory threshold on the sale of electronic cigarettes will favour bigger businesses, and tobacco companies – with their multi-billion-Euro budgets – are more likely to survive heavy-handed and expensive regulation than the current SMEs in the e-cig market. This is presumably why the only UK company which is voluntarily seeking medicines licensing for one of its products was bought out by a tobacco company.
Electronic cigarettes are not tobacco products, so it is only sensible and logical that they are not covered by the Framework Convention on Tobacco Control.
As already stated, they are not tobacco products, and since they do not generate second hand (or indeed first hand) smoke, it is unclear why this should be a problem. And with regards to taxation: the point of high taxes on tobacco is an attempt to force people to stop inhaling smoke. Isn’t switching to a safer nicotine source doing exactly that?
The suggestion that e-cigs should be regulated as both tobacco and medical products is simply bizarre – on many levels: if a product can be considered as both a tobacco product and a medicine, is this not inviting the tobacco companies to meddle in the medicines market? Does anyone – especially the WHO – want tobacco companies in the smoking cessation market?
How – and indeed, why – is a product that does not contain tobacco to be classified as a tobacco product? If the presence of tobacco-derived nicotine is sufficient grounds for tobacco classification, will this affect NRT products? Would this mean that synthetic nicotine would be exempt?
Would it be possible to make medicinal claims for tobacco products? This type of dual regulation seems certain to cause more problems than it solves – and presents significant legal problems as well.
‘ENDS’ contain toxic chemicals; there’s no denying it. However, so does almost everything. Ambient air in high traffic density areas is a great (or terrible) example. Formaldehyde is present in exhaled breath; nitrosamines are found in bacon; and heavy metals are present in tap-water. It is the levels that cause potential concerns, not the mere presence.
Does increasing use demonstrate that heavy-handed, burdensome new regulation is needed, or does increasing use without evidence of epidemiological risk indicate that introducing stricter regulation is unnecessary – and may even be actively harmful?
Claims that the product is for smoking cessation already require medicines licensing, so that is already covered. Given that it is already well-established that the emissions from electronic cigarettes are much less toxic than those of cigarettes, the reduced harm of electronic cigarettes is already proven.
The extent to which a product requires a heavy burden of regulation should relate to the proven risks, or risks that are logically supported by the composition of the product – not an assertion that because we don’t know everything about a product we should assume we know nothing about it, and pro-actively apply heavy-handed regulation on the basis of risks that are entirely theoretical.
World Health Organisation or World Harm Organisation? You decide.