I'm annoyed about this, and hoping it goes our way...
Here's the email I sent to all my MEPs yesterday:
Dear [MEP]
As the plenary debate on the TPD amendment approaches, I am writing to you again to express my concern about the effects of this amendment on the free availability of e-cigarettes as sensibly-regulated consumer devices within the EU.
I am a user of e-cigarettes who has now enjoyed 18 months without smoking (or even wanting to smoke), after a 23-year heavy smoking habit. I don't think I'll ever smoke again, as long as e-cigarettes remain freely available for me to use as it suits me. So I have been concerned for some time now about the proposed medicalisation of these devices (or of the nicotine-containing liquid, which would have the same effect) in the TPD amendment, which threatens to make these devices, and a wide choice of device, unavailable to me and the hundreds of thousands of other "vapers" in the EU.
I was heartened to read your response a few weeks ago promising to take into account the scientific evidence in deciding on your position.
As I'm unfamiliar with the ins and outs of the Parliament, Council and Commission, I relied on Clive Bates to point me to amendment 170 in his article here:
Everyone is involved but no-one is responsible – amending the tobacco directive « The counterfactual. I've read the amendment in full, and agree with his assessment that it's far better than the supposedly "light-touch" medicines regulation in amendment 71.
Still, I think 170 doesn't go far enough. In particular, the 30mg/ml limit on nicotine content is arbitrary in terms of any assessment of actual risks to users; I don't actually use liquid of this high strength myself, but one commenter who handles liquid up to and above 100mg/ml (10%) suggested that the actual hazards of nicotine solutions (e.g. through spillage on the skin, accidental ingestion) would justify, at most, a requirement for a low-level poisons license above 50mg/ml, and a ban on consumer sales above 100mg/ml. Many suppliers I use sell 64mg/ml liquid, which suggests that at least some users do find that this is the best option for them.
Other problems with this amendment are the restrictions on distance-selling, and the restrictions on advertising. These are sledgehammers to crack a nut. They represent the remnants of the attempt in the original TPD amendment - against all evidence - to try to regulate e-cigarettes in some ways as if they were cigarettes (the distance-selling measure is aimed at excise-duty fraud, which simply does not exist in the case of e-cigarettes), but simultaneously to restrict them more strictly than cigarettes by medicalising them. I expect their proponents to argue that the alternative is an unacceptable unregulated free-for-all: an utterly false dichotomy, which will continue to poison the debate as long as the terms of the original TPD amendment are allowed to frame it.
All "vaper" (e-cigarette user) groups and campaigners I've come across support a ban on sales to minors, a ban on advertising by means of "medical" claims, and the regulation of e-cigarettes and liquid under (generally existing) consumer safety regulations, and would welcome sensible laws that provided for this. It's only the extremism of those who want to see e-cigarettes classified as medicines that has allowed the impression to arise that the only alternatives are medicines regulation or no regulation.
So I'm in favour of amendment 170, and urge you to support it and oppose amendment 71. (Elsewhere, Clive Bates raises some very good points against Linda McAvan's recommendment of amendment 71:
The rapporteur’s case for regulating e-cigarettes – a line by line examination « The counterfactual)
But there's also something more important you can do in the Parliament and to your fellow MEPs, given that the debate will not end here. That is to re-iterate, again and again, the actual facts about e-cigarettes, in the hope that these facts might penetrate the debate, and perhaps redirect it from the unproductive question
Should e-cigarettes be regulated as medicines?
which is clearly nonsensical and should have reached a dead end long ago, onto the far better question:
What is the most appropriate way to regulate e-cigarettes, given what we currently know about them?
So the facts again:
1. E-cigarettes do not match any acceptable definition of "medicine". They are not presented, advertised or used to treat, relieve or manage disease. Unlike medicines, they don't make enormous promises about their effects to distressed people (such as those suffering from disease), and so shouldn't have to meet the same standards. They're more akin to other substances taken into or applied to the body, for different purposes; substances which could be harmful and should be subject to some safety measures: food, cosmetics and drinks.
2. In parallel with these "abstract" observations about definitions, the real world in the form of several courts in member states and the EP's own JURI committee have come to the same conclusion: that classifying e-cigs as medicines will not stand up legally.
3. Of course we don't yet know what the long-term health effects of e-cigarettes are. But the tiny number of (well-known and studied) substances contained in them, in comparison with cigarettes, makes it highly likely that any such effects that are discovered in the future will be minor in comparison with those from smoking.
a) IF they are attractive to smokers as an alternative to smoking (which is true), then even if there are undiscovered harmful effects, smokers are making a rational choice by switching to an alternative that carries an unknown, but low risk of causing some damage to their health (as opposed to smoking, which carries a known, high risk of seriously damaging their health) ; and any regulation should allow this choice or even encourage it.
b) IF they are being taken up by non-smokers, and in particular by young people who've never smoked (which is either not true or not established, a recent shockingly distorted reportage of a US study notwithstanding), then they still represent a lower-risk outcome for these people compared with taking up smoking. Perhaps a large uptake by these people would justify measures to prevent it or discourage it; but good regulation in this area would be contingent on:
i. Actually measuring and establishing this uptake, in a scientifically valid way;
ii. Finding out how many (if any) of these people would have taken up smoking instead, if e-cigs weren't available - these people still represent a public-health "win", because they're doing something lower-risk instead of smoking (credit to Carl Phillips for this observation); and
iii. Designing any regulatory response carefully to specifically target non-smoking users and young people, while avoiding making e-cigs less available to the people in
(a) - smokers and ex-smokers.
The supposed justifications for medicine regulation show no sign of this kind of careful assessment of risk. Instead, all possible risks, including unknown ones (future discoveries that e-cigs do harm health in some way) and invented ones ("gateway" effects from e-cigs to smoking, enormous uptake of e-cigs by minors, threats to the "social denormalisation" of smoking, when e-cigarettes are clearly distinguishable from cigarettes) are thrown, undiscounted, into a pot, and cooked up into a miasmic bubbling stew of fear. This is because medicines classification is
an utterly incoherent response to the challenge of e-cigarettes: it needs a hysterically inflated assessment of risk to help it pass critical muster.
4. Medicines regulation is not "light touch". The UK MHRA - which is probably more committed to "light-touch" than its equivalents in other member states - has already stated that none of the currently existing e-cigarette products would satisfy its requirements to be licensed. The costs would put most of the existing small businesses out of business.
5. There is also the matter of example. Even if the EU TPD on regulating e-cigs as medicines was proportionate, and truly "light-touch", it is simply wrong to set a high-profile, highly-publicised precedent by saying e-cigarettes are medicines, when they're clearly not - even if all kinds of more sensible qualifications exist in the small print. A Hungarian e-cig user told me of the effects of the recent ill-thought-out classification of nicotine as a pharmaceutical product in Hungary: nicotine (except, of course, perhaps, in cigarettes), now seems to fall under the ambit of a severe law against the adulteration or counterfeiting of medicines, which specifies penalties of up to 3 years' imprisonment merely for possession of more than a certain quantity of the substance. There medicinal classification has inappropriately made nicotine subject to a law that is really only justified to protect the public's trust in licensed pharmaceuticals for the treatment of disease - a truly perverse outcome.
I urge you to use your voice in the European Parliament and among your colleagues to raise these matters in debate, to help ensure a proportionate and rational legislative response to the challenge of e-cigarettes.
yours faithfully
[me]
Grrrrrrrrrrr.....
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