ECITA Blog

Destroying the appeal of a product to its current and potential users might as well be a ban….

by Tom Pruen and Katherine Devlin

As the debate on e-cigs has moved on, it is clear that Linda McAvan, MEP, Rapporteur on the TPD for the ENVI Committee, has recognised that medicines regulation is not the best approach, and her amendment reflects this. It does, however, still include a number of proposals which are problematic – both in terms of the products themselves, and the practicalities of implementation and enforcement.

Mrs McAvan proposes that:

1. Nicotine-containing products may only be placed on the market if they are authorised pursuant to:

(a) Directive 2001/83/EC, or

(b) The simplified procedure as set out in paragraph 2 and 3.

Off to a good start, (although an ‘either’ wouldn’t go amiss after ‘pursuant to’) but unfortunately, things go downhill in the simplified procedure:

2. Under the simplified procedure, Member States shall require manufacturers and importers of nicotine-containing products to submit an application for a marketing authorisation, which shall contain the following:

(a) Evidence that the product is manufactured in accordance with the principles and guidelines of Good Manufacturing Practice;

(b) A detailed description of the product in question, including all ingredients and quantities thereof, as well as information on emissions;

(c) A Risk-Management Plan, including a system for monitoring and recording any adverse reactions; Member States shall be entitled to charge a fee for processing the application. They may also require manufacturers or importers to carry out additional tests or submit additional information.

Each Member State shall take due account of authorisations previously granted by another Member State.

Evidence of the implementation of a form of good manufacturing practice makes sense – but not necessarily the GMP that is used for pharmaceuticals; neither food, drink nor indeed tobacco cigarettes are manufactured to such an exacting standard. Something that encourages suppliers to improve their standards and helps to improve standards at the point of manufacture (which, for the majority of hardware, is in China) would be useful, but a subset of medicines regulation is not the way to do it.

Disclosure of ingredients and testing for emissions are also a good idea – in principle. However, without a standard with which to compare them, how is it possible to make any judgement of what these should be? Research (particularly a study by Goniewicz et al[i]) strongly suggests that the emissions are more dependent on the liquid constituents than the hardware, and it is common for users to use different liquid than that supplied by the initial hardware vendor.  It is worth noting that the levels of toxicant emissions reported this study are low, with the most prevalent, formaldehyde, below the NOEL (No observable effect level) reported by Heath Canada[ii], except in one instance. Even then, the levels compared with those found in smoke are low, with Goniewicz et al reporting a level nine times lower in vapour than in smoke.

As a result of this, we need more research if we are to reduce emissions to even lower levels (although it is not immediately apparent why this is deemed necessary for most products) and following this research, a standard could be set against which to evaluate products. Without such research, any attempt to evaluate the emissions (except by comparison with tobacco smoke) is largely meaningless, and since there is no conceivable way in which emissions could be as high as cigarette smoke, there is little point in making such a comparison.

As far as I am aware, there is no requirement for tobacco products to have a Risk Management Plan – rather fortunately for the tobacco industry. It’s also unclear how someone would differentiate between risks from the hardware, and risks from the refill liquid.

Setting an open-ended requirement for additional testing or evidence would ensure a total lack of harmonisation across the Member States.  Member States would be able to set the level of evidence required at any level – including effectively requiring a full medicines application.

3. For products authorised under the simplified procedure, Member States shall ensure that the following conditions are fulfilled:

(a) the product is clearly labelled with the nicotine content, instructions for use, instructions for reporting adverse reactions, and details of the manufacturer;

(b) each unit packet and any outside packaging shall carry the following health warning: This product is intended for use by existing smokers aged 18 or over as an alternative to tobacco cigarettes. It contains nicotine which is a highly addictive substance. Consult your doctor if you are pregnant, breast feeding, allergic to nicotine or propylene glycol, or have high blood pressure.

The suggested warning falls far short of the information required under the current chemical labelling regulations – particularly the warnings to keep to products out of reach of children, and a requirement for child resistant packaging. Furthermore, it is already a legal requirement to label the nicotine content.

The warning statement also potentially contradicts the variable limit to match the age limit to that of the sale of tobacco products in different Member States.

We heartily support the advice to consult a medical professional if a consumer has any concerns about using the product. Since nicotine is known to cross the placental barrier and into breast milk, pregnant women should be able to make an informed choice with the advice of their healthcare team. Although nicotine is potentially harmful to the foetus/baby, switching from smoking – with the significant harms that can cause – to a non-combustible nicotine source is likely to be an improvement for the majority of those who find themselves unable to stop using nicotine. This is why pregnant women who cannot quit may be offered NRT products.

It seems somewhat bizarre to suggest that a smoker may be aware that they are allergic to nicotine, and yet be able to continue to smoke! Rather than this rather quaint notion, it would be far more relevant and useful to include a nut allergy warning, since some tobacco-flavoured electronic cigarettes contain nut flavourings. (You will find such warnings on ECITA members’ products.)

But then again…

(c) flavourings shall not be allowed;

The proposed removal of all flavourings is clearly aimed at making the product less appealing as a means of initiating nicotine addiction. However, since a nicotine solution does not have a significant inherent flavour of its own, this would be a ban on all types of flavouring, including tobacco. It is not hard to see that this would reduce the appeal of the product to smokers – a rather problematic unintended consequence of an attempt to protect young people and/or non-smokers who, the evidence suggests, (i.e. studies recently conducted by ASH (UK), as well as in the US) have no interest in the product anyway.

It also creates a situation where users will be driven away from the flavourings they are currently using, which have a chemical composition intended to be safe to inhale supplied by specialist companies, to using food flavourings which can contain substances that are known inhalation risks. (Many food flavours are in an oil base, which should not be inhaled, and diacetyl and related diketones – common in food flavourings, and entirely safe for digestion, but not inhalation – are known to cause damage to the lungs).

(d) the sale of the product shall be restricted in line with the legal age for sale of tobacco products in the relevant Member State;

This contradicts the proposal to mandate a warning specifying 18 as the age limit. There are different age restrictions on the sale of tobacco products in different Member States.

(e) the products shall be available to be sold outside pharmacies;

What is the purpose of this proposal? Electronic cigarette products are currently sold in pharmacies, as well as in tobacconists, supermarkets, corner shops, concession stands, and in dedicated retail shops. (And yet it is still easier to find tobacco cigarettes to purchase than to find electronic cigarette products….) Only classification as a medicinal product could limit the sale of electronic cigarettes exclusively to pharmacies.

(f) advertising and promotion shall be appropriately regulated;

The statement that advertising and promotion shall be appropriately regulated is effectively meaningless; unless the products are a clearly-defined product type (e.g. medicine or consumer product) how is it possible to decide what regulations are appropriate? Under the current situation, with electronic cigarette products classified as consumer products, there is ample legislation in place to regulate their advertising and promotion – specifically to ensure that the act of smoking is not glamourised in any way. These, and all the other regulations already in place, merely need better enforcement across the Member States.

4. Member States shall monitor the development of the nicotine-containing products market, including any progress made in harm reduction, as well as any evidence of gateway use amongst young people. Based on the evidence, the Commission shall report back to the European Parliament and the Council 5 years after the transposition date of this Directive. The report shall assess whether amendments to this Directive are necessary.

This form of monitoring makes a great deal of sense, in theory. However since this proposal would result in significant differences in regulation across the Member States, (and simultaneously achieve an effective ban on the current range of products with the proposed restrictions on flavourings), the data gathered would not be of great value in making assessments about the situation in Europe as a whole.

As most of the users of these products are middle-aged smokers, it is also debateable whether five years is long enough for any significant epidemiological changes to be seen as a result of harm reduction.

Analysis from Tom Pruen

Although not presented at the Workshop for the ENVI Committee, the German Cancer Research Center, DKFZ, has compiled a large document on electronic cigarettes, and made a presentation to MEPs a few weeks ago. Unlike many of the presentations I have blogged about recently, they have actually looked at a fair selection of the available research, but unfortunately, I cannot agree with the majority of the conclusions they have drawn. A large proportion of the issues are the same as those identified in my recent blogs – the mere presence of something does not imply a significant risk. About the only genuinely new ‘risk’ identified by the DKFZ is a suggested link between the use of Glycerol and lipoid pneumonia, (apart from a concern over the dangers of children choking on 50ml bottles. This suggestion is so patently absurd that I’m forced to wonder if the authors have even the vaguest common sense, let alone scientific knowledge. To put this in perspective, this is a warning that children may choke on things that have an internal volume of 50 cubic centimetres – something significantly larger than a golf ball. If it is the internal contents that are of such concern, perhaps the DKFZ would also like to prohibit the sale of household chemicals in bottles – after all, bleach often comes in litre bottles. Of course, current legislation requires both bleach and e-liquid to be in child resistant containers – and be labelled to keep out of the reach of children, but why let facts get in the way of a good alarmist story?)

This ‘link’ is based on a single case, reported in April 2012 in the publication Chest. The unfortunate patient had a number of underlying health conditions:

“Her past medical history also was significant for asthma, reported rheumatoid arthritis, fibromyalgia, schizoaffective disorder, and hypertension. Her medications included amlodipine, albuterol metered dose inhaler, lovastatin, lisinopril, multiple vitamins, cycloben, zaprine, citalopram, and multiple psychiatric medications.”

She had started vaping approximately 7 months before treatment, with the onset of respiratory symptoms coinciding with this. She was advised to stop using her electronic cigarette, and her condition improved.

At first blush, this would imply a causative link, but much remains unclear.

For those who are unfamiliar with lipoid pneumonia, here is a summary, drawn primarily from here:

Exogenous lipoid pneumonia is caused by the inhalation of lipids (fats and oils) from outside of the body. It’s most commonly seen in elderly patients (in their 60′s and 70′s), and is more likely in people with an impaired swallowing ability and “the consistent use of the various kinds of oils – mineral, animal, and less commonly, the vegetable oils found in laxatives, nasal drops, mouth spray, oral lubricants, insecticides or traditional folk remedies” (and perhaps not surprisingly, fire eaters, for whom it is an occupational hazard). It tends to be associated with long exposure to oils; one study had a mean of 9.5 years, but brief exposures of as little as a month have been known (with liquid paraffin).

Endogenous lipoid pneumonia is caused by a build-up of the body’s natural fats – it is also known as cholesterol pneumonitis – in the lung. It’s most commonly seen in people with chronic bronchial obstruction, often tumours or foreign bodies. In fact, it has a very large association with cancers of the lung (and to a lesser extent with Hodgkin’s lymphoma):

“In one research conducted, endogenous lipoid pneumonia was diagnosed in the resected lungs of 33 of 147 patients with lung cancer. It was found in 16 out of 89 (18%) of patients with adenocarcinoma and in 17 of 55 (31%) patients with squamous cell carcinoma. In 23 cases, it was observed that endogenous lipoid pneumonia was localized to lung parenchyma distal to the airway obstructed by the tumour, and of these 16 were patients with squamous cell carcinoma. Out of 5 patients with adenocarcinoma, 4 had endogenous lipoid pneumonia present distal to the tumour and having spread to isolated segments.”

Smoking (perhaps not surprisingly) also has an effect on levels of fat within lung tissue:

“When normal lung tissue is chemically analysed, it shows a total fat content of 8.63 per 100 g of dry tissue, of which 19% is cholesterol; although this percentage shows a marked increase in smokers. When the breakdown of these cells takes place, it results in the lipid gaining access to lung parenchyma and it is phagocytosed by the pulmonary macrophages”.

(For those without a medical dictionary to hand, lung parenchyma indicates the functional parts of the lung, and phagocytosed is the body’s attempt to remove dead cells and foreign bodies at the cellular level using white blood cells.)

Lipids are often based on glycerol, but glycerol itself is not a lipid, so there is no clear causative link, although this is something outside of my area of expertise, and I would welcome expert input. It does seem improbable, however, since glycerol is readily absorbed and metabolised by the body, and indeed the enzyme responsible for glycerol metabolism is found in lung tissue.

It’s possible that she may have inhaled nose drops based in oil, or have added oils to her electronic cigarette; (a lot of food flavourings are in a base of oil, making them unsuitable for use in electronic cigarettes – one of the reasons that specialist suppliers of ‘vape-friendly’ flavours have entered the market). She may even have been using paraffin as a laxative. (It sounds silly, but this is one of the most common causes of lipoid pneumonia.) It may have been a result of her pre-existing lung condition – asthma; her medication included a statin, suggesting that she may have had high cholesterol levels; or it may have been caused by incompatibility with one of her medications and vaping. Again, this is something I would welcome expert input on.

However, if glycerol were likely to cause lipoid pneumonia, given the millions of users of electronic cigarettes, we would expect some more significant epidemiological indication of this. It seems more likely to have been caused by other, unreported factors, most probably over the course of several years.

If there were a likely metabolic pathway between inhalation of glycerol and lipoid pneumonia, I would also assume that this would have been raised by the European Respiratory Society, rather than the DKFZ.

In the unlikely event that glycerol does turn out to have inhalation risks, it is of course entirely possible for the electronic cigarette industry to stop using it.

Analysis from ECITA’s Tom Pruen

As before, slides are skipped when content or comment free.

Hmm…. The European Society of Cardiology’s (ESC) website says:

Unless Dr Pisinger is an unpaid volunteer, representing an organisation which receives funding from every major manufacturer of medical nicotine products surely constitutes a conflict of interest?

This is basically a lie. We have a number of analytical studies of the ingredients, both before and after vapourisation, and from this, a good idea of the levels of potential toxins the user is exposed to. We have also benefited from 100 years of advances in medical and scientific knowledge generally, so the risks can be better evaluated.

One hundred years ago, chemical analysis was much more qualitative than quantitative, and the theory of causation for cancers left much to be desired. We know far more about e-cigs than we do about tobacco cigarettes even today, since tobacco is a natural product, subject to wide variation, and the pyrolysis of its components gives rise to a huge array of chemicals.

What does this graph even purport to show, other than an apparently scary correlation? If you want to provide information, labelling the axis of your graph is vital.

Where is the data to support this graph? Is there any evidence whatsoever to substantiate this correlation? Certainly, no research I am aware of supports it, and since it is not referenced, I can only assume it is entirely fabricated.

I’m fairly sure that the irony of using a crystal ball to draw a scary-looking graph before moving onto this slide escaped Ms Pisinger.

We have hundreds of thousands of users (if not millions, worldwide), so the information will become available – provided, of course that the products continue to be widely available, and provided that the effect of electronic cigarette use is big enough to measure.

Nicotine containing products containing nicotine is a rather odd thing to find alarming. Traces of toxins, indeed; at similar levels to those found in medicinal products – which are clearly already ‘safe’, otherwise there couldn’t be any alleged need to reclassify e-cigs as medicines.

As for “changes in the lung” – the particle size and composition of a vapour is likely to be altered by most changes of environment (unlike smoke particulates, which being primarily solids are hard to affect), but there is no reason to suppose that this poses any increased risk.

This last point is possibly more irritating to me than to most people, but why is ‘The Chemical Change’ headed with a radiation trefoil?  I can only assume this use of alarmist imagery is purely for the purposes of scaremongering. These idiots are supposed to be scientists, yet apparently the difference between chemistry and radiation physics eludes them.

The products, and the level of understanding of those studying them, have both evolved significantly in a short space of time, so comparing new and old data is meaningless.

Since the products have been available for a number of years, and no acute effects have been identified by increased patient hospital admissions, other medical interventions, or in the worst scenario, deaths, the acute risks are clearly not a cause for huge concern.

This has been the case historically, in less scrupulous quarters of the industry, and does highlight a need for better quality control in some sections of the market – and indeed better enforcement. However, having incorrectly labelled contents is already covered by product description legislation.

Why is there a picture of a tin of Marlboro and a pack of soup? Of what conceivable relevance is this, other than to find an excuse to put a big tobacco brand on the page?

There are over 30,000 Adverse Events (AEs) for medicinal nicotine products – in fact, it’s safe to say that the number of AEs is related to the number of users. To give a real world idea of relative risk, let’s compare e-cigs with an approved smoking cessation treatment – Champix:

It’s easy to say that there is a causal relationship – but this seems unlikely for most of the events reported. Since congestive heart failure is a disease developed over an extensive period and, as has been noted already, e-cigs are new products, a causal link seems unlikely. More probable is that the unfortunate heart attack victim was a smoker for many years, and switched to e-cigs too late.

Leaving aside the scientific validity of using Google searches of online forums as a data-gathering tool, there still remain several questions – particularly relating to the severity of the symptoms, and their duration. If the ESC had actually engaged with the users of electronic cigarettes, they would have discovered that this research does not reflect the experience of users, and that for the majority, the negative effects are of short duration, and comparatively mild.

Given that the “‘light’ catastrophe” was caused by manipulating machine yields of smoke constituents, there is every reason to conclude that a method that removes the smoke completely WILL yield significant health benefits.

If the question is “do we want to save lives?” then yes, harm reduction is good enough. If the question is “do we want to eliminate the tobacco industry, regardless of who else is driven out of business or killed in the process?”, then the answer is clearly no.

Quitting smoke is much more important than quitting nicotine – and this distinction is what makes saving lives through e-cigs such a huge public health opportunity.

If 75% of smokers wish to quit, why are they still smoking?

A combination of factors:

• more say they want to quit than are actually willing to try;

• most attempts fail (regardless of pharmaceutical intervention).

Is it not, therefore, better to try something else to help save the lives of this 75% (and indeed some of the other 25%)?

Several meta-analysis have shown that the long-term success rate for NRT interventions is under 10%.

Why is it considered acceptable for a ‘medicine’ to have a 90% failure rate?

As a consumer product, people will only buy e-cigs if they work for them.  Market forces will remove any products that do not satisfy consumers and NRT products will remain an option for those wanting to quit nicotine entirely – except that failing to quit e-cigs does not usually involve returning to smoking.

This seems to be rather lacking in internal logical consistency: if kids are fast learners, they will see the difference.

I think it is an insult to children to suggest that they are unable to discern the difference between smoke (which smells awful, lingers, and stains surfaces) and vapour which does none of the above.

Similarly, any child with a functioning brain will be able to identify the difference between a product that is burnt during use, such as a cigarette, and one that remains unchanged throughout. It is also highly probable that adults will educate their children in the dangers of smoking in a much less hypocritical (and therefore more likely to succeed) way if they have switched to a reduced harm product.

Examining these rather disturbing proposals in order:

In an attempt to not repeat the errors of the past, is it better to knowingly and deliberately kill people now than run the risk of maybe potentially causing deaths in the future?

Despite the exaggeration of unknowns, alarmist descriptions of risks, and the dismissal of much of the existing evidence, there remains NO EVIDENCE that there ARE significant long-term harms from e-cigs, nor that there are likely to be. Therefore, what legal, moral or ethical justification is there to regulate them in a proscriptive way that reduces availability or requires changes to the product that will make them less appealing to smokers?

(This leaves aside the madness of dual regulation, which is covered in a previous post.)

‘Efficacy’ is a medical term. E-cigs do not need to be ‘efficacious’; e-cigs need to appeal to smokers as an attractive alternative to tobacco cigarettes. They do.

So is this ignorance presented as evidence, or a deliberate attempt to mislead, deceive and create unwarranted fear? You decide.

More analysis from Tom Pruen, Chief Scientific Officer of ECITA

As in previous presentation commentary, slides are skipped where comment is not needed or content is lacking. The full version can be found here.

The irony of a public health advocate quoting a US defence secretary who resigned after accusations that “he has shown himself incompetent strategically, operationally and tactically, and is far more than anyone else responsible for what has happened to our important mission” lends an air of tragedy to this presumably well-intentioned but terribly-executed presentation.

That didn’t take long – the first error: those of us who actually have knowledge about e-cigs, know they also usually contain Glycerol.

Taking this in order:

We know that almost all users report an improvement in breathing, but the long terms effects are little known – mainly as the products have not been on the market for that long. This extends to anecdotal reports from COPD sufferers reporting measurable increases in lung function; (anecdotal evidence of far lesser provenance was entered into the record by the WHO representative).

We know that the majority of users find them a satisfying alternative to tobacco cigarettes – thereby enabling them to avoid the proven dangers of inhaling smoke.

A number of studies (Schripp et al, Goniewicz et al) have demonstrated that the emissions from e-cigs, while not completely safe, are of very low risk – especially compared with tobacco cigarettes.

TSNAs have been found in some products, as have metals – in minuscule amounts, with little evidence of risk.

We know, without any doubt WHATSOEVER, that the use of these products is safer than smoking; all that is open to debate is by how much. On the basis of the growing body of currently available evidence, the risks are extremely low.

Once again, taking this hyper-cautious prattling in order:

As has already been stated, the current level of evidence allows us to conclude that there is no conceivable means through which the use of e-cigs could be as dangerous as smoking.

Grounds for concern? Concern for what, exactly? Tobacco industry profits? Funding for health NGOs?

Since all available evidence (and indeed simple logic) clearly indicates that e-cigs cause less harm than smoking, concerns about public health are simply not an issue here.

The biggest potential risk is driving people back to a product that kills half of its users. Risk cannot be completely avoided since everything has some level of risk associated with it – we do not prohibit crossing the road, or insist that people only cross at approved crossing points.

Since we know that e-cigs are much safer than smoking, the precautionary principle should dictate that nothing should be done which will reduce the availability of these products; after all, first do no harm.

Finally! Not one, not two, but three things we can agree with!

We would love to see independent clinical trials (provided they are actually independent of bias from their funding, framing, or the way they are conducted and reported);

We completely agree that regulation should be based on science, and be robustly supported by evidence – which is why alarmist fear-mongering is not helpful. However, since e-cigs are NOT a tobacco product, and indeed directly compete with tobacco products for market share, what relevance does the FCTC have?

The ERS may well be experts in respiratory medicine, but clearly, they are rank amateurs when it comes to electronic cigarette science.

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.

… and offers the hope of saving millions of lives across the EU.

Just for a change, I don’t want to say too much on this subject, but I was driven to share with you the almost poetic beauty of the wording of the JURI Opinion on the Tobacco Products Directive, specifically with regard to electronic cigarettes. Here’s what they had to say:

“For those who already consume tobacco products, the promotion and development of less harmful products and products for smoking cessation is essential. […]

Some provisions in the Commission’s proposal also raise serious doubts as to their conformity with fundamental rights such as the right to property, the right to freedom of expression and information and the freedom to conduct business. These rights are enshrined in the Charter of Fundamental Rights of the European Union (“the Charter”) and may only be limited pursuant to Article 52(1) of the Charter if the limitation is necessary, genuinely meets objectives of general interest and is proportional. […]

Article 18 of the proposal prohibits nicotine-containing products (NCP) such as e-cigarettes containing a certain nicotine level if they are not authorised pursuant to Directive 2001/83/EC (the Medicinal Products Directive). It is, however, quite unclear if these products (which are much less harmful than tobacco products) even fall under the scope of the Medicinal Products Directive.¹ For products which do not fall under the Directive, this would effectively constitute a ban. Banning products which are less harmful than tobacco products and which can be a means of smoking cessation is certainly not in line with the public health aims of the proposal.²

¹ Relying on the strict jurisprudence of the CJEU, several national courts have already held that e-cigarettes cannot be qualified as a medicinal product by function under the Medicinal Products Directive, see e.g. Oberverwaltungsgericht Nordrhein-Westfalen, 24 April 2012, 16 L 2043/11.

² Article 18 also lacks a valid legal base as it is in no way aimed at improving the conditions for the establishment and functioning of the internal market. Pursuant to the Commission, the provision will allow NCP to move freely across borders as they would benefit from the mutual recognition procedure under the Medicinal Products Directive (Impact Assessment, page 8). However, this is already the case without Article 18, as any NCP which qualifies as a medicinal product is already now subject to the Medicinal Products Directive. The only effect Article 18 has is that it prohibits the placing on the market of NCP that are not authorised pursuant to the Medicinal Products Directive.

[…]

The Committee on Legal Affairs calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:”

… and deletes every reference to nicotine-containing products from the proposed revised Tobacco Products Directive, with the justification:

“The requirement of authorisation of nicotine containing products pursuant to Directive 2001/83/EC could seriously restrict access to products which are less harmful than tobacco products and which can help tobacco consumers to quit. Additionally, the measures proposed cannot be based on Article 114(1) TFEU and therefore lack any legal base.”

Glad that’s clear then, but what now of the workshop to emphatically make the case for medicinal reclassification?

Shame it’s not legally viable, eh?

Another very interesting week in Politicoville…

While the ENVI Committee has arranged its workshop for 7^th May with a distinctly biased panel of ‘experts’, neatly lined up to make a case for the reclassification of electronic cigarettes as medicinal products, effectively banning them and removing them from the millions of EU citizens who are already vaping instead of smoking (not to mention the many more millions who would not have the option to even try them), the JURI Committee – the Legal Affairs team – has published its Draft Opinion. And guess what?

There is no legal basis for reclassifying electronic cigarettes as medicinal products, and no legal or moral justification for restricting access to products demonstrably far less harmful than smoking tobacco.

The workshop agenda reads like a who’s who (WHO?) of zealous ANTZ whose single-minded aim is the utter destruction of the tobacco industry, to be achieved by denormalising (and dehumanising) smokers. Heaven forbid that smokers should be offered products that are a demonstrably attractive, appealing and far, far less dangerous alternative. No, say the ANTZ. They will still look like they’re smoking, and they’ll be enjoying themselves, and that doesn’t fit with our plans at all!

Following an intro by the ENVI Rapporteur, Linda McAvan MEP, and a position statement from the European Commission, the line-up includes:

Roberto Bertollini, Chief Scientist and WHO Representative to the European Union – allocated 15 minutes to speak.

“Biography

Dr Roberto Bertollini holds a degree in medicine and a postgraduate degree in paediatrics, as well as a master’s degree in public health from the Johns Hopkins University, United States of America. In addition to his position as WHO Representative to the European Union, Dr Bertollini is Chief Scientist with the specific task of supporting the Regional Director’s Office with the scientific evidence that underpins WHO health policies and strategies.

From 2007 to 2010, he was coordinator of evidence and policy for the environment and health at WHO headquarters, from 2000 to 2007 he was a technical director at WHO/Europe, and from 1993 to 2000, he was the founding director of the WHO European Centre for Environment and Health in Rome, Italy.

His main professional interests concern the environmental influences on health, with special reference to the effects of emerging threats such as climate change as well as the use of epidemiology for public health policy development and the evaluation of public health programmes and practices.”

I am sure that Dr Bertollini is a dedicated professional, with the very best of intentions, but since his job is to deliver the WHO’s position, his contribution to this workshop is unlikely to be helpful concerning electronic cigarettes. (The WHO’s position was set out in no uncertain terms here.)

This will be followed by 40 minutes from various medicines regulators. Yes, that’s right: medicines regulators… for 40 minutes. I wonder if anyone can guess what their perspective on this issue is likely to be?

Well, the first of these is Jeremy Mean from the MHRA. (I don’t think he likes me very much.) In February 2010, the MHRA’s position was that electronic cigarettes are dangerous (wrong) unregulated (untrue) products which ought to be removed from the market immediately (within 21 days), or be given one year to get a marketing authorisation (impossible), or left alone (but this last option was worded in such a way as to be a ‘non-option’).

(The MHRA Public Consultation MLX364 can be found here.)

The Regulatory Policy Committee gave MLX364 a resounding thumbs down in June 2010.

The MHRA’s report of the outcome of this public consultation included the following detail on work it would be carrying out:

“The programme of research will include a work stream on investigation of the levels of nicotine which have a significant pharmacological effect, the actual use of existing nicotine products in the marketplace, their effect on smoking cessation and modelling of the potential impact of bringing these products into medicines regulation on public health outcomes. We envisage the programme of research will take about 18 months to complete and that a final decision on the regulation of nicotine containing products will be made in Spring 2013.”

Well Spring has sprung, the grass is riz, I wonder where the evidence is? Perhaps we shall find out on Tuesday….

The other medicines regulators are from Germany – where two court cases have been fought and lost by Health Ministries in two of the Bundesländer, and Finland, whose National Institute for Health and Welfare had this to say in February last year:

“‘According to the reliable research available, electronic cigarettes contain the same components that endanger health as conventional cigarettes, some that even cause cancer,’ says the Director General of THL, Pekka Puska. The long-term effects on the functioning of the respiratory organs are not well known. Research has also shown that the quality of the liquids used in electronic cigarettes varies greatly, and that the product descriptions do not always match the real contents.

‘FIOH urges workplaces to treat the smoking of electronic cigarettes in the same way as that of real cigarettes. A non-smoking workplace is the most advisable solution,’ says Harri Vainio, Director General of FIOH.”

(How they have the audacity to describe what fed into this position as ‘reliable research’ is beyond me!)

So it is unlikely – at best – that any of these presenters will have anything useful to contribute to this workshop, which is supposed to be providing information for MEPs so that they can make informed decisions in the legislative process.

Part 3 of the bill of fare for this workshop is entitled “Scientific information: clinical and research findings”, and who is topping the list? Oh dear, oh dear – the European Respiratory Society. Many of you will remember the outrageous behaviour of Professor Christina Gratziou in dramatically misrepresenting her research findings to the press, leading to dangerously misleading headlines in the papers such as “Electronic cigarettes ‘could damage your lungs’ as they cause less oxygen to be absorbed by the blood” – not even remotely borne out by the (as yet unpublished) study referred to. (For more on this, see our blog post here.)

This has severely damaged the European Respiratory Society’s credibility, particularly with regard to electronic cigarettes! Mercifully, it is not Professor Gratziou who will be presenting, but Professor Francesco Blasi.

Does Professor Blasi take a more enlightened, public-health-focussed approach? Judge for yourselves:

“‘at present, we have no certain figures to say if e-cigs are good or bad for your health’, although they can ‘have an incidence on young people’, giving rise to a new lifestyle and vicious circle of emulation and addiction.”

So that’s a ‘no’ then.

Next up is Dr Charlotta Pisinger, Senior research fellow at Research Centre for Prevention and Health, Copenhagen. Surely she will want to promote harm reduction strategies for smokers?

“There is no control of the e cigarette and some of them have been found contamination with very harmful / toxic substances. In addition, you have no idea what effect inhaling fumes all day, for perhaps years, has on the lungs. With e-cigarette consumed in everyday life, will be smoking again normalized, which affects the social norm. One can assume that it will thus inspire children to start smoking or smoke vapor cigarettes. And it’s really a bad thing, she says.”

So that’s another ‘no’, then.

The final speaker in this section of the workshop is Jean-François Etter, whose presentation is entitled ‘Understanding nicotine addiction’.

Many of you will have read Dr Etter’s book (as have I), The Electronic Cigarette: an Alternative to Tobacco? (If you haven’t done so yet, I can highly recommend it.) On the whole, Dr Etter has spoken a great deal of good sense on the subject of electronic cigarettes. Furthermore, he has made a significant and very useful contribution to the scientific evidence base with two published papers (here and here).

However, there is a possibly unavoidable bias in favour of some kind of light touch medicinal regulation for electronic cigarettes. It often feels as if these eminent professionals are incapable of recognising any value to any kind of regulation unless it is medicines regulation – despite the well-publicised and frequent failings. (See Chantix, Seroxat, MHRA dereliction of duty, Avandia, Device regulation scandal, etc.)

As it stands, Dr Etter is the only one in the current line up from whom there is even the slightest chance of hearing anything positive about electronic cigarettes, but the context is still likely to be with reclassification as a medicinal product. Where is Professor Gerry Stimson, the father of Harm Reduction? Where is Clive Bates, former Director of ASH UK? Where is Dr Konstaninos Farsalinos, who is tirelessly providing the very studies policy-makers keep asking for? Where is Professor Peter Hajek? Dr Jacques Le Houezec? Dr Carl Phillips? Paul Bergen? Anyone with something useful to contribute???

None of these renowned experts has been invited to provide the benefit of their considerable knowledge and expertise in this field. Not one.

Finally, a grand total of five minutes – yes, five minutes – will be given to the German ecig consumer group, IG-ED. Five minutes to rebut these professors, scientists, doctors, and experienced political players. Five minutes to describe the vital importance of keeping electronic cigarettes in the hands of the millions of former smokers who have already made the switch. Five minutes to make the case for ensuring that current and future smokers who have not yet made the switch are given that opportunity. Five minutes to beg for their lives – and yours, and mine.

Nice to see that there will be a balanced position, isn’t it?