EU E-cigarettes face new restrictions UK
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I'm not going to ask you how old you are, Ref. I will ask you to think about something, though. I'm 30 and I plan on living a long time now that I've given up cigarette smoking. I have absolutely no intention of giving up vaping. Can any of us really afford to buy enough supplies to last us the rest of our lives? Can we depend on those supplies to be working and/or useable in even 10 years time? Have we got enough space to store them?
JJ
I think with high quality mechanical mods and rebuildable atomizers and enough bits and bobs to repair them with, then yes it's possible. The kicker for some people will be the nicotine. I've drifted down to 0mg mostly and use 2mg for a kick here and there when I feel like it. So, I'm good. However, when we thought the FDA might take it away at any time I always entertained the notion of vaping DIY 0mg juice for the hand to mouth fix and wearing a patch for the nicotine. Don't know how well it would have worked, but that was the plan to keep me off the ciggies(if the government screwed vaping up) when I was still using nicotine.
A serious blow for us in the UK 
, no i do not intend to stock up for life, but i'm sorry i will not go back to analogues & my opinion is its against my human rights to not have that freedom of choice.
I do make my own juice & fortunately do have some quality equipment that will last.ie Provari.
Problem will be the the nic juice.Silly as it is, probably will be bought & sold on Black market like analogues are.
, no i do not intend to stock up for life, but i'm sorry i will not go back to analogues & my opinion is its against my human rights to not have that freedom of choice.I do make my own juice & fortunately do have some quality equipment that will last.ie Provari.
Problem will be the the nic juice.Silly as it is, probably will be bought & sold on Black market like analogues are.
It is mainly the nicotine aspect that concerns me. We shouldn't need to stockpile mesh, wicks and wire because those of have uses beyond the remit of vaping and will likely still be available. I would also want to collect some really high quality mechs, which would require a significant up-front investment.
With regard to nicotine: I'm at 12mg now. I suppose that gives me 3 years to wean myself down to 0mg. I'm a lot less dependent on nicotine than I used to be - it still surprises me how well I cope with long-haul flights these days. However, at this point in my life, using nicotine is a choice. The thought of having that choice taken away from me sends shivers down my spine.
JJ
This is a massive blow to us in the UK
The devices shouldn't be an issue to be honest, because they aren't necessarily exclusively used for vaping nicotine based products, the same way shops can sell bongs etc for smoking "tobacco".
The only thing they can forcefully regulate is the nicotine content within the juice, but i am sure straight up nicotine is already "licensed" it's just the mixture of the nicotine and flavors that becomes a target.
The devices shouldn't be an issue to be honest, because they aren't necessarily exclusively used for vaping nicotine based products, the same way shops can sell bongs etc for smoking "tobacco".
The only thing they can forcefully regulate is the nicotine content within the juice, but i am sure straight up nicotine is already "licensed" it's just the mixture of the nicotine and flavors that becomes a target.
This is a massive blow to us in the UK
The devices shouldn't be an issue to be honest, because they aren't necessarily exclusively used for vaping nicotine based products, the same way shops can sell bongs etc for smoking "tobacco".
The only thing they can forcefully regulate is the nicotine content within the juice, but i am sure straight up nicotine is already "licensed" it's just the mixture of the nicotine and flavors that becomes a target.
Unfortunately they see an ecig as a single unit or a two piece at most. I think loose juice would be extremely problematic to get a license for without specifying the delivery method. I fear while devices cant be regulated getting anything other than 0nic will mean importing. They wont care about that, if it discourages new users from switching, job done.
eedjits. I've emailed all my MEPs asking them not to take this as an example to follow. (Suggest everyone does the same!). Working on adapting my email to MP and MSPs (I'm in Scotland):
Dear [Mr/Ms]
I am writing to you again in light of the recent announcement that the UK MHRA will attempt to regulate e-cigarettes as medicinal products.
I am extremely dismayed by this decision, which is indefensible on any rational public-health grounds. I'm particularly concerned that this decision - irrespective of its actual merits - will be taken up as an argument to support of the similar Europe-wide measures in the amendment to the EU TPD. "The UK is treating e-cigarettes as medicines, so it must be a good idea"; a case of the blind leading the blind.
Courts in the Netherlands, German states (1) and Estonia (2) have already struck down attempts to classify e-cigarettes as medicines: the recent MHRA decision may also face a legal challenge at the national level. The e-cigarette measure in the TPD amendment would thus contradict and over-ride explicit legal decisions at the national level (rather than filling in a legal vacuum, as is often claimed); while this in itself doesn't mean the measure is wrong, it does put a strong onus on its proponents to explain and justify it.
As a user of e-cigarettes, who thanks to them gave up a 23 -year 20-25 cigarettes/day habit overnight a year ago, I'm very interested in this issue. I know I'm using a relatively new product, and I'm alert to any real evidence that e-cigarettes might be bad enough for my health to make them a worse choice than cigarettes.
I've read widely on both sides of the debate - but I haven't found one single argument in favour of this measure that holds water. Worse, the rhetoric used by pro-ban advocates is full of scare tactics, selective and distorted reporting of scientific studies, and outright lies. (Jean-François Etter, professor of public health at the University of Geneva, has put his disgust at the use of these tactics in a presentation to the European Parliament by the WHO on record (3)).
I vividly remember the debate about the ban on smoking in public places in Scotland. I was relieved when the ban was finally adopted, even though I was a smoker at the time. Once the ban was enacted, I had to smoke outside; I would have preferred separate indoor smoking areas, but when a government decision finally closed the debate, I was relieved to no longer have to try to engage with the nonsense, scaremongering, "think of the children"-ism, distortions of scientific evidence and sheer shameless lying that was mobilised in favour of the ban.
In that debate some people argued that the ban should be resisted because it represented the thin end of the wedge: if smokers reasonably gave ground on this issue to the reasonable interests of non-smokers, this would only open the way to further, utterly unreasonable measures, such as a ban on smoking in private homes or vehicles.
At the time I thought these people were slightly paranoid. I now think they were right; because I'm seeing the same propaganda tactics being deployed, to justify restricting devices which are not even cigarettes, do not cause harm to bystanders, and are used by smokers to reduce or quit their smoking!
(Among the tactics are:
a. false claims about the effect on young people, marketing to young people, and use by young people;
b. spotlighting of "dangerous" substances present in e-cigarette vapour, obscuring the fact that these substances are present at harmless concentrations (4, 8);
c. scare stories about "passive vaping" without scientific basis (5);
d. Claims that "we don't know what is in e-cigarette vapour", when we do. (6);
e. one case of illness, with many other possible causes present, being used to suggest a risk of lipoid pneumonia from e-cigarettes (7)
)
I've tried to make sense of campaigns to restrict or ban e-cigarettes, as scientifically-based public-health campaigns, and I simply can't make sense of them on that basis. I've come to the conclusion that this is simply because they are not scientifically-based. Anti e-cigarette campaigners have simply decided, on no basis other than their association with cigarettes, that e-cigarettes must be stopped; the "science" comes later. I feel that the inability of anti-smoking campaigners to make much progress in banning actual, real cigarettes is being translated into misdirected efforts to ban an easier target.
Clive Bates, ex-director of ASH UK, has I think put his finger on something similar (9): his analysis suggests that the aim of some in the anti-tobacco lobby has become tobacco control as a good in itself, rather than the actual good outcomes that tobacco control is intended to produce. The logic would then be: if we ban e-cigarettes, we get a higher tobacco control activity score (10). The actual public-health effects - clearly negative, from banning e-cigarettes - are irrelevant. (E-cigarettes are not currently included on the Tobacco Control Scale: but the essential point is that, with regard to anything associated with cigarettes or tobacco, a mentality of "ban it and get brownie points" has taken hold).
Bates' "10 reasons not to regulate e-cigarettes as medicines" (11) clearly states what is wrong with the MHRA's decision.
I hope that you will take the time to scrutinise any evidence presented to you on this issue; the debate is plagued by attention-grabbing, "easy to digest" headlines, which usually bear no relation to the scientific foundation behind them. Shamefully, even supposedly reputable organisations are engaging in this kind of practice (12). This is why Prof. Michael Siegel, of Boston University School of Public Health, calls his blog (referenced below) "The rest of the story".
I urge you to vote against the amendment to the TPD in its current form, and to encourage a constructive attitude from the EU towards electronic cigarettes, which have enormous potential to improve public health, if understood properly and regulated appropriately.
yours faithfully
[me]
References
1. http://www.ecita.org.uk/response to proposed revision of tpd 160113.pdf
2. http://www.ecita.org.uk/kohtuotsus_e-sigaretid_zandera vs ravimiamet_ha-3-12-2345_07032013_en-us.pdf
3. Some truth about e-cigarette regulation and the appalling F-grade presentation of the WHO « The counterfactual
4. Why the WHO is not qualified to attempt to educate people about electronic cigarettes | ECITA Blog
5. Stanton Glantz is a liar (as if thats news) | Anti-THR Lies and related topics
6. http://tobaccoanalysis.blogspot.co.uk/2013/02/when-will-anti-smoking-researchers-stop.html
7. http://tobaccoanalysis.blogspot.co.uk/2013/06/german-cancer-research-center-corrects.html
8. Beware: e-cigarette vapor contains (gasp!) air. | Anti-THR Lies and related topics
9. Are you being manipulated? The wisdom of the WHO examined « The counterfactual
10. Association of European Cancer Leagues - Tobacco Control Scale 2010
11. 10 reasons not to regulate e-cigarettes as medicines « The counterfactual
12. The European Society of Cardiology presentation at ENVI workshop ignorance presented as evidence, or a deliberate attempt to deceive? | ECITA Blog
Dear [Mr/Ms]
I am writing to you again in light of the recent announcement that the UK MHRA will attempt to regulate e-cigarettes as medicinal products.
I am extremely dismayed by this decision, which is indefensible on any rational public-health grounds. I'm particularly concerned that this decision - irrespective of its actual merits - will be taken up as an argument to support of the similar Europe-wide measures in the amendment to the EU TPD. "The UK is treating e-cigarettes as medicines, so it must be a good idea"; a case of the blind leading the blind.
Courts in the Netherlands, German states (1) and Estonia (2) have already struck down attempts to classify e-cigarettes as medicines: the recent MHRA decision may also face a legal challenge at the national level. The e-cigarette measure in the TPD amendment would thus contradict and over-ride explicit legal decisions at the national level (rather than filling in a legal vacuum, as is often claimed); while this in itself doesn't mean the measure is wrong, it does put a strong onus on its proponents to explain and justify it.
As a user of e-cigarettes, who thanks to them gave up a 23 -year 20-25 cigarettes/day habit overnight a year ago, I'm very interested in this issue. I know I'm using a relatively new product, and I'm alert to any real evidence that e-cigarettes might be bad enough for my health to make them a worse choice than cigarettes.
I've read widely on both sides of the debate - but I haven't found one single argument in favour of this measure that holds water. Worse, the rhetoric used by pro-ban advocates is full of scare tactics, selective and distorted reporting of scientific studies, and outright lies. (Jean-François Etter, professor of public health at the University of Geneva, has put his disgust at the use of these tactics in a presentation to the European Parliament by the WHO on record (3)).
I vividly remember the debate about the ban on smoking in public places in Scotland. I was relieved when the ban was finally adopted, even though I was a smoker at the time. Once the ban was enacted, I had to smoke outside; I would have preferred separate indoor smoking areas, but when a government decision finally closed the debate, I was relieved to no longer have to try to engage with the nonsense, scaremongering, "think of the children"-ism, distortions of scientific evidence and sheer shameless lying that was mobilised in favour of the ban.
In that debate some people argued that the ban should be resisted because it represented the thin end of the wedge: if smokers reasonably gave ground on this issue to the reasonable interests of non-smokers, this would only open the way to further, utterly unreasonable measures, such as a ban on smoking in private homes or vehicles.
At the time I thought these people were slightly paranoid. I now think they were right; because I'm seeing the same propaganda tactics being deployed, to justify restricting devices which are not even cigarettes, do not cause harm to bystanders, and are used by smokers to reduce or quit their smoking!
(Among the tactics are:
a. false claims about the effect on young people, marketing to young people, and use by young people;
b. spotlighting of "dangerous" substances present in e-cigarette vapour, obscuring the fact that these substances are present at harmless concentrations (4, 8);
c. scare stories about "passive vaping" without scientific basis (5);
d. Claims that "we don't know what is in e-cigarette vapour", when we do. (6);
e. one case of illness, with many other possible causes present, being used to suggest a risk of lipoid pneumonia from e-cigarettes (7)
)
I've tried to make sense of campaigns to restrict or ban e-cigarettes, as scientifically-based public-health campaigns, and I simply can't make sense of them on that basis. I've come to the conclusion that this is simply because they are not scientifically-based. Anti e-cigarette campaigners have simply decided, on no basis other than their association with cigarettes, that e-cigarettes must be stopped; the "science" comes later. I feel that the inability of anti-smoking campaigners to make much progress in banning actual, real cigarettes is being translated into misdirected efforts to ban an easier target.
Clive Bates, ex-director of ASH UK, has I think put his finger on something similar (9): his analysis suggests that the aim of some in the anti-tobacco lobby has become tobacco control as a good in itself, rather than the actual good outcomes that tobacco control is intended to produce. The logic would then be: if we ban e-cigarettes, we get a higher tobacco control activity score (10). The actual public-health effects - clearly negative, from banning e-cigarettes - are irrelevant. (E-cigarettes are not currently included on the Tobacco Control Scale: but the essential point is that, with regard to anything associated with cigarettes or tobacco, a mentality of "ban it and get brownie points" has taken hold).
Bates' "10 reasons not to regulate e-cigarettes as medicines" (11) clearly states what is wrong with the MHRA's decision.
I hope that you will take the time to scrutinise any evidence presented to you on this issue; the debate is plagued by attention-grabbing, "easy to digest" headlines, which usually bear no relation to the scientific foundation behind them. Shamefully, even supposedly reputable organisations are engaging in this kind of practice (12). This is why Prof. Michael Siegel, of Boston University School of Public Health, calls his blog (referenced below) "The rest of the story".
I urge you to vote against the amendment to the TPD in its current form, and to encourage a constructive attitude from the EU towards electronic cigarettes, which have enormous potential to improve public health, if understood properly and regulated appropriately.
yours faithfully
[me]
References
1. http://www.ecita.org.uk/response to proposed revision of tpd 160113.pdf
2. http://www.ecita.org.uk/kohtuotsus_e-sigaretid_zandera vs ravimiamet_ha-3-12-2345_07032013_en-us.pdf
3. Some truth about e-cigarette regulation and the appalling F-grade presentation of the WHO « The counterfactual
4. Why the WHO is not qualified to attempt to educate people about electronic cigarettes | ECITA Blog
5. Stanton Glantz is a liar (as if thats news) | Anti-THR Lies and related topics
6. http://tobaccoanalysis.blogspot.co.uk/2013/02/when-will-anti-smoking-researchers-stop.html
7. http://tobaccoanalysis.blogspot.co.uk/2013/06/german-cancer-research-center-corrects.html
8. Beware: e-cigarette vapor contains (gasp!) air. | Anti-THR Lies and related topics
9. Are you being manipulated? The wisdom of the WHO examined « The counterfactual
10. Association of European Cancer Leagues - Tobacco Control Scale 2010
11. 10 reasons not to regulate e-cigarettes as medicines « The counterfactual
12. The European Society of Cardiology presentation at ENVI workshop ignorance presented as evidence, or a deliberate attempt to deceive? | ECITA Blog
Thanks e-pipeman - I hope people find it useful in trying to get some sense into legislation!
Apologies for the length of this. Further reply to a reply from an MEP.
I find it incredibly difficult to explain succinctly why this whole MHRA/EU TPD decision is so wrong. I think it's because there's hardly a premise or argument in their position which bears the slightest relation to the facts.
Any feedback or pointing out of factual mistakes welcome.
Dear [MEP]
Thank you for your considered reply, which has provoked much thought.
I agree with you that the difficult challenge on this issue is to find the right balance.
My main concern is that rational policy-making, applying regulation in proportion to the actual risk of harm, and with recognition that no legislative measure (even medicinal licensing) can eliminate all risk (or misuse - e.g. by minors), will lose out in favour of gesture politics ("anything like smoking must be bad/not cracking down on it will 'give the wrong message'"), unexplored appeals to the emotive word "addiction" (a concept which medical science finds extremely difficult to pin down, let alone to definitely tie to harm), or simple misinformation.
With regard to the last, I think you must have been misinformed about the much higher nicotine content of e-cigarettes compared to cigarettes. The important figure, of course, is not the total content (much of which may end up "wasted", remaining in the device or residue), but the amount of nicotine delivered to the user. And on this measure, the MHRA's own research (1) shows precisely the opposite:
"Although EC can deliver nicotine in levels close to those provided by nicotine replacement treatments, none of the tested products delivered levels as high as conventional cigarettes".
(p.19)
"Given the low toxicity of nicotine at the doses observed and the fact that long before any dangerous levels of nicotine concentration could be reached, an over-enthusiastic user would be warned by nausea, there is little concern that e-cigarettes can harm their users by delivering toxic nicotine levels".
(p.20)
The MHRA's decision is thus very curious, because their overall assessment of the health risks (evaluating several existing studies) of e-cigarettes is also very favourable:
"Studies on EC users have identified little or none of the known toxins associated with tobacco smoking, and while [e-cigarettes] may not be entirely safe, no serious health risks have been identified".
(p.33)
I can only assume that the MHRA felt bound by the restricted range of options they proposed to themselves: licensing as a medical product, or "do nothing"; and, being unwilling to do nothing, chose the other option. (They were criticised by the Regulatory Policy Committee, back in 2010, for not considering other regulatory options). This is very unfortunate, because "boxing-in" the debate into the framework of medical product regulation distorts it and impedes an accurate understanding of the unique benefits (and possible risks) of e-cigarettes by all parties.
While there are a whole range of possible attitudes, from my harm-reduction atttitude ("99% less harmful than cigarettes, used overwhelmingly by smokers/ex-smokers to reduce tobacco use, so very little safety case to answer") to a more precautionary approach ("Not enough long-term research yet, so we should restrict use of e-cigarettes"), if we're forced to talk about e-cigarettes either as effective medicines on the one hand or as harmful "cigarette-alikes" (with all the passive smoking problems, for instance) on the other, then we're not talking about e-cigarettes as they actually are, and drafting regulations that actually match the reality of the situation will be impossible.
The EC's first draft of the TPD: a false start
So I think the EC hasn't been very helpful here in its initial draft of the TPD amendment. I think this initial draft should be viewed as a first, not very successful attempt to define possible regulation of these sui generis products, a draft to be discarded and replaced with something better. If it's allowed to frame the debate as a whole, then the debate will fail to capture what is distinctive about e-cigarettes.
1. Definition by nicotine content
Clearly, a product that could deliver a lethal or very harmful dose of nicotine in normal usage should not be allowed on the market. The levels of nicotine in e-cigarettes, and those discussed in the TPD, are far below these levels.
At these real-world levels, the nicotine content of a product is pretty meaningless. In front of me is a 30ml bottle of e-liquid. It happens to be of 6mg nicotine/ml concentration, because that's my preferred concentration. But many vapers use 24mg/ml liquid, so let's take that as a benchmark. This bottle would thus contain 720mg of nicotine.
This sounds like a lot of nicotine. But how would I, or anyone else, actually absorb this nicotine into my body? The bottle has a warning label, and a childproof cap (both of these safety measures are great ideas, but are already widely enforced by existing regulation - the EU could harmonise these measures). The liquid has an apple fragrance, which makes it pleasant to inhale when vapourised: but the taste of the unvapourised liquid is so vile that putting even a drop on my tongue makes me wash my mouth out (and causes me no ill effects).
My preferred vaping device has an unusually large capacity (3ml). The purpose of this (apart from making refilling less frequent) is to make room for a better-quality atomiser and wick, which produces a better flavour. But whatever the capacity of the device, it simply isn't possible (as the MHRA notes) to deliver a lethal or dangerous dose of nicotine, because the rate at which the liquid is vapourised is so slow. Going back to my actual 6mg/ml strength, I find that 3ml of liquid lasts me more than a day: even assuming 100% absorption, I'm getting less nicotine than the average 20-a-day smoker (18mg vs 28mg/day - see (2)).
My 720 mg bottle of e-liquid (which lasts me about 2 weeks) is thus about as dangerous as the full bottle of whisky in the next room. The whisky bottle probably contains enough ethanol to kill me: but unless I'm suicidally deranged, it isn't possible for me to consume it fast enough to harm myself - my bodily reactions will become unbearably unpleasant long before I reach that level.
The MHRA's own research measured nicotine delivery mechanically from the vapour, rather than as a bodily effect in the bloodstream of a vaper: but their results are consistent with my points - the strongest product they tested delivered only 15mg of nicotine (to the vapour, not to the body) in 300 puffs. Assuming an unusual, unrealistic rate of 1 puff/minute, this would equate to 5 hours of continous vaping, with little time or attention left available to devote to normal daily tasks!
In trying to legislatively isolate and define e-cigarettes for the purposes of regulation by their nicotine content, the EC is missing the target, by failing to appreciate how e-cigarettes actually work. First of all, an absolute limit of 2mg of nicotine makes no sense (2mg per what?). Secondly, the concentration limit of 4mg/ml diverts attention onto the nigh non-existent risk of fast consumption in large quantities, taking no account of the actual, normal usage pattern (and technical limitations) of e-cigarettes, which (as the MHRA's own research shows) can only deliver nicotine relatively slowly, even when using high-strength liquid, and certainly cannot deliver a lethal or harmful dose.
Finally, their third attempt at quantification (a bodily effect of 4ng nicotine/ml plasma) is not supported as a level high enough to justify medical licensing. The figure of 4ng/ml is not related to actual researched harmful or toxic levels. Levels as high as 50ng/ml have been recorded in heavy smokers of cigarettes, who carry on living; and the well-known harmful long-term effects of smoking have never (as far as I know) been attributed to this factor.
The general effect of the EC's initial draft is thus to confuse, rather than enlighten the debate. An important unintended consequence is that the figures used may encourage the (false) beliefs that:
a. Any level of nicotine in plasma is dangerous (false - eating tomatoes or eggplant delivers nicotine to the bloodstream)
b. A plasma level above 4ng/ml is dangerous enough to warrant medical licensing (false or at best, extremely arguable and not supported by argument)
c. Substances with a concentration above 4mg nicotine/ml are inherently dangerous to handle (false)
d. A quantity of nicotine of 2mg or above is inherently dangerous, whatever its form (true only in pure form, or very high concentrations: 24mg/ml is only approximately 2.4%)
e. Regulation is urgently needed to protect consumers from harmful or toxic levels of nicotine, which they would otherwise be exposed to through e-cigarettes (false)
f. In the absence of strict regulation, consumers could all too easily inadvertently consume harmful amounts of nicotine from e-cigarettes (false - there is a clear and immediate bodily feedback mechanism limiting this).
2. Determination to medicalise e-cigarettes
The trouble is that e-cigarettes simply will not work as medicines; the EC's first draft goes wrong because it proposes to deal with legitimate uncertainty about the absolute, 100% safety of e-cigarettes, not by considering them as they are, but by attempting to turn them into something essentially different. An effective, productive debate is clearly impossible under this constraint.
The enormous vibrancy and success of the e-cigarette market in attracting smokers (which even the MHRA acknowledges in its Impact Assessment) can be attributed to the fact that it offers smokers enormous choice.
a. I can choose to try vaping, and find it works or give it up as not for me.
b. I can choose to vape exclusively, quitting cigarettes completely (as I've done); or to replace some cigarettes with vaping (as many others have).
c. I can choose from hundreds of different flavours of e-liquid. I haven't liked many of the liquids I've tried, but it's obvious from the volume of sales that other people do like these flavours.
d. I can choose the nicotine concentration that suits me. I started on 18mg/ml, but now use 6mg/ml. Others find that 24mg/ml or 36mg/ml suits them better.
e. I can choose from dozens of different devices, each of which offers a different combination of vapour production, flavour intensity and vapour temperature, to suit my preference.
f. Most importantly, I self-titrate my consumption of nicotine (adjust my own dosage), just as smokers do, by taking more or less puffs, or longer or shorter puffs.
All these factors contribute to making e-cigarettes so appealing as an alternative to smoking. And all of them make it impossible to treat e-cigarettes as medicine. The costs involved in medical licensing (for all these thousands of combinations of battery, atomiser, liquid flavour and liquid strength) would be prohibitive (3); the effect would be to destroy this wide product market and replace it with a few approved products, produced by an oligopoly of manufacturers wealthy enough to bear the licensing costs, and appealing only to a small fraction of the current vaping population. Many vapers might return to smoking as a result - a public-health disaster.
It's the last factor - self-titration - that makes e-cigarettes particularly unamenable to classification as a medicine. Medicines are designed to deliver a correct, standard dose to the vast majority of potential users, with the risk of an over- or under-dose in individual cases identified and assessed for its impact. They're licenced as safe on this basis. But it's impossible to apply this standard to devices which allow for (and rely on, for their effectiveness) widely different usage and dosage patterns from person to person. Moreover, the necessity for these strict standards in the case of medicines arises from the patient's vulnerability to consuming an incorrect dose without realising it. This danger does not arise from nicotine-inhalation devices, which provide near-immediate conscious feedback of the effect of the dose.
A better approach to e-cigarettes as a possible subject of regulation
This approach would start by:
1. Recognising (as the MHRA's own research does) that no significant health risks from e-cigarette use have yet been found.
2. Recognising that, given the enormous public-health benefits of providing smokers with an easily-available, cheap, enjoyable alternative to smoking (even one which only works for some of them), the low risk that adverse health effects will be discovered is an acceptable risk.
3. Recognising that in practice e-cigarettes are used almost exclusively by smokers and ex-smokers: the harm-reduction argument thus applies.
4. Rejecting the unsupported myth that e-cigarettes are being marketed to children (4); harmonising the currently practised ban on sales to under-18s.
5. Rejecting the equally mythical belief that second-hand vapour poses a health risk to bystanders, thus acknowledging that including e-cigarettes in smoking bans (e.g. in the workplace) has no basis in health science.
5. Recognising that the availability of a wide range of flavours are a necessary part of the appeal of e-cigarettes to a wide range of smokers.
6. Recognising that the wide variety of products is a valuable feature of the e-cigarette market, and that requiring individual per-product medical certification would be unrealistic.
7. Formulating a generic definition of e-cigarettes that captures the wide variety of products currently available, as well as (as far as possible) possible future, improved products.
8. Soberly evaluating the actual risks to health of nicotine (distinct from those from smoking), and working out a suitable warning message to be applied to nicotine products, thus ensuring that consumers have informed freedom of choice.
9. Granting generic approval to these products as consumer products for use by adults, subject to certain safety standards.
10. Drawing up these safety standards on the basis of an assessment of the actual health risks, consideration of the dosage, and a comparison with actual, everyday levels of exposure to airborne chemicals. For example, some minor variations in nicotine concentrations (e.g. 6ml/mg liquid varying from 5-7mg/ml) would be acceptable, whereas some extreme variations (6ml/mg labelled liquid actually containing 20mg/ml) would not. As another example: some organic compounds, toxic at high concentrations, might be detected in vapour. But if the actual exposure is comparable to the exposure from household furnishings, or from sitting in a car, then this should not be treated as an urgent risk factor.
Going back to drawing-board in this way will be much harder work than simply accepting the EC's original draft, or tweaking it with amendments. But this is only because, in my opinion and that of many public-health experts, the original draft is fundamentally flawed.
yours faihfully
[me]
References
1. http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286844.pdf
2. How much nicotine is absorbed following electronic cigarette use? | ECITA Blog
3. MHRA Cost Analysis of Creating a Medicinal E-Cig
4. We need to talk about the children – the gateway effect examined « The counterfactual
I find it incredibly difficult to explain succinctly why this whole MHRA/EU TPD decision is so wrong. I think it's because there's hardly a premise or argument in their position which bears the slightest relation to the facts.
Any feedback or pointing out of factual mistakes welcome.
Dear [MEP]
Thank you for your considered reply, which has provoked much thought.
I agree with you that the difficult challenge on this issue is to find the right balance.
My main concern is that rational policy-making, applying regulation in proportion to the actual risk of harm, and with recognition that no legislative measure (even medicinal licensing) can eliminate all risk (or misuse - e.g. by minors), will lose out in favour of gesture politics ("anything like smoking must be bad/not cracking down on it will 'give the wrong message'"), unexplored appeals to the emotive word "addiction" (a concept which medical science finds extremely difficult to pin down, let alone to definitely tie to harm), or simple misinformation.
With regard to the last, I think you must have been misinformed about the much higher nicotine content of e-cigarettes compared to cigarettes. The important figure, of course, is not the total content (much of which may end up "wasted", remaining in the device or residue), but the amount of nicotine delivered to the user. And on this measure, the MHRA's own research (1) shows precisely the opposite:
"Although EC can deliver nicotine in levels close to those provided by nicotine replacement treatments, none of the tested products delivered levels as high as conventional cigarettes".
(p.19)
"Given the low toxicity of nicotine at the doses observed and the fact that long before any dangerous levels of nicotine concentration could be reached, an over-enthusiastic user would be warned by nausea, there is little concern that e-cigarettes can harm their users by delivering toxic nicotine levels".
(p.20)
The MHRA's decision is thus very curious, because their overall assessment of the health risks (evaluating several existing studies) of e-cigarettes is also very favourable:
"Studies on EC users have identified little or none of the known toxins associated with tobacco smoking, and while [e-cigarettes] may not be entirely safe, no serious health risks have been identified".
(p.33)
I can only assume that the MHRA felt bound by the restricted range of options they proposed to themselves: licensing as a medical product, or "do nothing"; and, being unwilling to do nothing, chose the other option. (They were criticised by the Regulatory Policy Committee, back in 2010, for not considering other regulatory options). This is very unfortunate, because "boxing-in" the debate into the framework of medical product regulation distorts it and impedes an accurate understanding of the unique benefits (and possible risks) of e-cigarettes by all parties.
While there are a whole range of possible attitudes, from my harm-reduction atttitude ("99% less harmful than cigarettes, used overwhelmingly by smokers/ex-smokers to reduce tobacco use, so very little safety case to answer") to a more precautionary approach ("Not enough long-term research yet, so we should restrict use of e-cigarettes"), if we're forced to talk about e-cigarettes either as effective medicines on the one hand or as harmful "cigarette-alikes" (with all the passive smoking problems, for instance) on the other, then we're not talking about e-cigarettes as they actually are, and drafting regulations that actually match the reality of the situation will be impossible.
The EC's first draft of the TPD: a false start
So I think the EC hasn't been very helpful here in its initial draft of the TPD amendment. I think this initial draft should be viewed as a first, not very successful attempt to define possible regulation of these sui generis products, a draft to be discarded and replaced with something better. If it's allowed to frame the debate as a whole, then the debate will fail to capture what is distinctive about e-cigarettes.
1. Definition by nicotine content
Clearly, a product that could deliver a lethal or very harmful dose of nicotine in normal usage should not be allowed on the market. The levels of nicotine in e-cigarettes, and those discussed in the TPD, are far below these levels.
At these real-world levels, the nicotine content of a product is pretty meaningless. In front of me is a 30ml bottle of e-liquid. It happens to be of 6mg nicotine/ml concentration, because that's my preferred concentration. But many vapers use 24mg/ml liquid, so let's take that as a benchmark. This bottle would thus contain 720mg of nicotine.
This sounds like a lot of nicotine. But how would I, or anyone else, actually absorb this nicotine into my body? The bottle has a warning label, and a childproof cap (both of these safety measures are great ideas, but are already widely enforced by existing regulation - the EU could harmonise these measures). The liquid has an apple fragrance, which makes it pleasant to inhale when vapourised: but the taste of the unvapourised liquid is so vile that putting even a drop on my tongue makes me wash my mouth out (and causes me no ill effects).
My preferred vaping device has an unusually large capacity (3ml). The purpose of this (apart from making refilling less frequent) is to make room for a better-quality atomiser and wick, which produces a better flavour. But whatever the capacity of the device, it simply isn't possible (as the MHRA notes) to deliver a lethal or dangerous dose of nicotine, because the rate at which the liquid is vapourised is so slow. Going back to my actual 6mg/ml strength, I find that 3ml of liquid lasts me more than a day: even assuming 100% absorption, I'm getting less nicotine than the average 20-a-day smoker (18mg vs 28mg/day - see (2)).
My 720 mg bottle of e-liquid (which lasts me about 2 weeks) is thus about as dangerous as the full bottle of whisky in the next room. The whisky bottle probably contains enough ethanol to kill me: but unless I'm suicidally deranged, it isn't possible for me to consume it fast enough to harm myself - my bodily reactions will become unbearably unpleasant long before I reach that level.
The MHRA's own research measured nicotine delivery mechanically from the vapour, rather than as a bodily effect in the bloodstream of a vaper: but their results are consistent with my points - the strongest product they tested delivered only 15mg of nicotine (to the vapour, not to the body) in 300 puffs. Assuming an unusual, unrealistic rate of 1 puff/minute, this would equate to 5 hours of continous vaping, with little time or attention left available to devote to normal daily tasks!
In trying to legislatively isolate and define e-cigarettes for the purposes of regulation by their nicotine content, the EC is missing the target, by failing to appreciate how e-cigarettes actually work. First of all, an absolute limit of 2mg of nicotine makes no sense (2mg per what?). Secondly, the concentration limit of 4mg/ml diverts attention onto the nigh non-existent risk of fast consumption in large quantities, taking no account of the actual, normal usage pattern (and technical limitations) of e-cigarettes, which (as the MHRA's own research shows) can only deliver nicotine relatively slowly, even when using high-strength liquid, and certainly cannot deliver a lethal or harmful dose.
Finally, their third attempt at quantification (a bodily effect of 4ng nicotine/ml plasma) is not supported as a level high enough to justify medical licensing. The figure of 4ng/ml is not related to actual researched harmful or toxic levels. Levels as high as 50ng/ml have been recorded in heavy smokers of cigarettes, who carry on living; and the well-known harmful long-term effects of smoking have never (as far as I know) been attributed to this factor.
The general effect of the EC's initial draft is thus to confuse, rather than enlighten the debate. An important unintended consequence is that the figures used may encourage the (false) beliefs that:
a. Any level of nicotine in plasma is dangerous (false - eating tomatoes or eggplant delivers nicotine to the bloodstream)
b. A plasma level above 4ng/ml is dangerous enough to warrant medical licensing (false or at best, extremely arguable and not supported by argument)
c. Substances with a concentration above 4mg nicotine/ml are inherently dangerous to handle (false)
d. A quantity of nicotine of 2mg or above is inherently dangerous, whatever its form (true only in pure form, or very high concentrations: 24mg/ml is only approximately 2.4%)
e. Regulation is urgently needed to protect consumers from harmful or toxic levels of nicotine, which they would otherwise be exposed to through e-cigarettes (false)
f. In the absence of strict regulation, consumers could all too easily inadvertently consume harmful amounts of nicotine from e-cigarettes (false - there is a clear and immediate bodily feedback mechanism limiting this).
2. Determination to medicalise e-cigarettes
The trouble is that e-cigarettes simply will not work as medicines; the EC's first draft goes wrong because it proposes to deal with legitimate uncertainty about the absolute, 100% safety of e-cigarettes, not by considering them as they are, but by attempting to turn them into something essentially different. An effective, productive debate is clearly impossible under this constraint.
The enormous vibrancy and success of the e-cigarette market in attracting smokers (which even the MHRA acknowledges in its Impact Assessment) can be attributed to the fact that it offers smokers enormous choice.
a. I can choose to try vaping, and find it works or give it up as not for me.
b. I can choose to vape exclusively, quitting cigarettes completely (as I've done); or to replace some cigarettes with vaping (as many others have).
c. I can choose from hundreds of different flavours of e-liquid. I haven't liked many of the liquids I've tried, but it's obvious from the volume of sales that other people do like these flavours.
d. I can choose the nicotine concentration that suits me. I started on 18mg/ml, but now use 6mg/ml. Others find that 24mg/ml or 36mg/ml suits them better.
e. I can choose from dozens of different devices, each of which offers a different combination of vapour production, flavour intensity and vapour temperature, to suit my preference.
f. Most importantly, I self-titrate my consumption of nicotine (adjust my own dosage), just as smokers do, by taking more or less puffs, or longer or shorter puffs.
All these factors contribute to making e-cigarettes so appealing as an alternative to smoking. And all of them make it impossible to treat e-cigarettes as medicine. The costs involved in medical licensing (for all these thousands of combinations of battery, atomiser, liquid flavour and liquid strength) would be prohibitive (3); the effect would be to destroy this wide product market and replace it with a few approved products, produced by an oligopoly of manufacturers wealthy enough to bear the licensing costs, and appealing only to a small fraction of the current vaping population. Many vapers might return to smoking as a result - a public-health disaster.
It's the last factor - self-titration - that makes e-cigarettes particularly unamenable to classification as a medicine. Medicines are designed to deliver a correct, standard dose to the vast majority of potential users, with the risk of an over- or under-dose in individual cases identified and assessed for its impact. They're licenced as safe on this basis. But it's impossible to apply this standard to devices which allow for (and rely on, for their effectiveness) widely different usage and dosage patterns from person to person. Moreover, the necessity for these strict standards in the case of medicines arises from the patient's vulnerability to consuming an incorrect dose without realising it. This danger does not arise from nicotine-inhalation devices, which provide near-immediate conscious feedback of the effect of the dose.
A better approach to e-cigarettes as a possible subject of regulation
This approach would start by:
1. Recognising (as the MHRA's own research does) that no significant health risks from e-cigarette use have yet been found.
2. Recognising that, given the enormous public-health benefits of providing smokers with an easily-available, cheap, enjoyable alternative to smoking (even one which only works for some of them), the low risk that adverse health effects will be discovered is an acceptable risk.
3. Recognising that in practice e-cigarettes are used almost exclusively by smokers and ex-smokers: the harm-reduction argument thus applies.
4. Rejecting the unsupported myth that e-cigarettes are being marketed to children (4); harmonising the currently practised ban on sales to under-18s.
5. Rejecting the equally mythical belief that second-hand vapour poses a health risk to bystanders, thus acknowledging that including e-cigarettes in smoking bans (e.g. in the workplace) has no basis in health science.
5. Recognising that the availability of a wide range of flavours are a necessary part of the appeal of e-cigarettes to a wide range of smokers.
6. Recognising that the wide variety of products is a valuable feature of the e-cigarette market, and that requiring individual per-product medical certification would be unrealistic.
7. Formulating a generic definition of e-cigarettes that captures the wide variety of products currently available, as well as (as far as possible) possible future, improved products.
8. Soberly evaluating the actual risks to health of nicotine (distinct from those from smoking), and working out a suitable warning message to be applied to nicotine products, thus ensuring that consumers have informed freedom of choice.
9. Granting generic approval to these products as consumer products for use by adults, subject to certain safety standards.
10. Drawing up these safety standards on the basis of an assessment of the actual health risks, consideration of the dosage, and a comparison with actual, everyday levels of exposure to airborne chemicals. For example, some minor variations in nicotine concentrations (e.g. 6ml/mg liquid varying from 5-7mg/ml) would be acceptable, whereas some extreme variations (6ml/mg labelled liquid actually containing 20mg/ml) would not. As another example: some organic compounds, toxic at high concentrations, might be detected in vapour. But if the actual exposure is comparable to the exposure from household furnishings, or from sitting in a car, then this should not be treated as an urgent risk factor.
Going back to drawing-board in this way will be much harder work than simply accepting the EC's original draft, or tweaking it with amendments. But this is only because, in my opinion and that of many public-health experts, the original draft is fundamentally flawed.
yours faihfully
[me]
References
1. http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286844.pdf
2. How much nicotine is absorbed following electronic cigarette use? | ECITA Blog
3. MHRA Cost Analysis of Creating a Medicinal E-Cig
4. We need to talk about the children – the gateway effect examined « The counterfactual
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