October 2nd, 2013

Everyone is involved but no-one is responsible – amending the tobacco directive

envelope2Updated 3 Oct.  The amendment number 170 on e-cigarettes [here] is now published and ready for consideration by the European Parliament on 8 October. As this was circulating on Monday 30th Sept, I wrote with comments and advice to the MEPs negotiating the amendment.  Given they ignored most of it (!) that, these comments and the advice can now be read as concerns and criticisms.  The proposed amendment is good and bad.  Good mainly because it rejects medicines regulation.  Never-the-less, I consider it significant progress and a breakthrough overall for which vapers should be proud.

It is good because it looks likely to succeed and therefore the destruction that would be caused by mandatory medicines regulation may be averted.  If the Parliament did agree mandatory medicines regulation on 8 Oct then that would have aligned it with the Council and Commission – and this bit of the directive would be a done deal and over. So now we have an alternative, and on the face of it acceptance in the Parliament that medicines regulation is not appropriate. But it is bad because it has introduced some really counterproductive stuff to appease the regulatory obsessives in the European Parliament, in order to secure a majority for it. The amendment is overall good because it allows two paths to market – everything is still possible under medicines regulation that would have before, but if this is agreed there would be an additional option. Most importantly it would signal that the Parliament is not convinced, and understands that medicines regulation is not ‘light touch’, not a good fit for these products, is laden with unintended implicit support for the tobacco industry and probably not lawful.   So it is good for its ‘hang-on-a-minute’ intrusion into the sloppy negligent consensus of the Council and Commission.

Sadly, the idea of standing aside and letting beneficial commerce take its course unhindered by bureaucratic burdens isn’t really what the European Parliament does, so we are stuck with this and their unbearable itch to regulate.  Also remember this isn’t the final text – it has to be agreed by the Council next (see what next? below). This then opens the prospect of finding a better way forward through the negotiation with the Council (‘trilogue’), Council first reading in December, EP second reading etc. [see note on process] All the while, we would expect awareness of the costs, risks and unintended consequences to grow.

Here is my note to the MEPs from earlier in the week:

Dear Members

I am writing to you because it is likely you are or will be involved in negotiating amendments on the tobacco products directive related to e-cigarettes and ‘harm reduction’ more broadly.

I have seen some of the proposals for amendments circulating and I would like to offer some brief comments and advice with a view to securing the best public health outcome and avoiding unintended support for the cigarette market.

1. Clarify that medicines regulation only applies where the products in question meet the legal definition of a medicine – that is where there are presented as treating or preventing disease. The courts have repeatedly and rightly rejected other definitions, and would likely do so again. The aim should be to achieve proportionate, non-discriminatory legislation, recognising that e-cigarettes are promising alternatives to smoking.

2. Avoid thresholds in nicotine density such as 30mg/ml. These limits provide no meaningful protections, but they do mean more heavily addicted smokers have to work harder to get a satisfactory experience from an e-cigarette, thus making switching less attractive to one of the most at-risk groups. The result would be a black market in stronger liquids, more home mixing and more smoking.

3. Applying the directives on tobacco advertising 2003/33/EC and 2010/13/EU to e-cigarettes would be disproportionate and counterproductive. These directives are highly restrictive but justified as internal market measures on the basis of harm to health caused by smoking. No such harm is remotely plausible for e-cigarettes. In fact, the opposite is true – wider uptake of e-cigarettes will be highly beneficial to health by reducing smoking. Removing valuable options for advertising e-cigarettes simply protects the incumbent cigarette brands. Controls on advertising e-cigarettes are justified to prevent marketing to children or making misleading actual or implied claims (2006/114/EC)

4. Protect Internet sales. There is a case for limiting internet sales of tobacco products primarily based on excise duty fraud.  No equivalent case exists for e-cigarettes. The e-cigarette retail market has a strong on line presence and this allows small businesses to compete for large markets beyond their physical locality, and ensures diverse supply and good consumer choice available throughout Europe. Internet based suppliers should of course meet the same standards as any other supplier, and be governed by established rules of e-commerce (2000/31/EC) and distance selling (97/7/EC).

5. Be wary of technical terms like ‘Good Laboratory Practice’. These have very specific meaning and should be used appropriately, and only where they offer benefits proportionate to costs. The application of GxP standards would be better introduced through a review and proper impact assessment with adequate consultation. [note they didn’t use this]

6. Don’t ignore smokeless tobacco. Snus is banned, it should not be – the public health harm reduction case is overwhelming, and there is no scientific, ethical or legal case for preventing smokers having access to it. There are three options: (1) treat it like any other smokeless tobacco – the most obvious and proper course; (2) allow it to be authorised as a novel product under Article 17 (it is ‘novel’ in most markets as it has been banned for more than 20 years; (3) allow it to be sold in those member states where it has been used traditionally.

I hope you find these points useful as you finalise amendments over the next couple of days. I am sure the e-cigarette industry will have additional points to make regarding practicalities, but these are the issues that I think are most important from a public health perspective.

Please contact me if you would like to discuss or would welcome further clarification.Yours sincerely
Clive Bates
Frédérique Ries, the MEP negotiating this from the Liberal ‘ALDE’ group wrote to MEPs today explaining their hopes the amendment.

Dear Colleague

The common amendment on e-cigs that I circulated last Friday on behalf of the ALDE group has now officially been co-signed  by EPP and ECR.  It is also gaining support by a lot of individual colleagues within the S&D delegations.

Our aim is to reduce smoking-related disease, and e-cigs can play a major role in helping smokers cut their use of tobacco.  We want e-cigs to be safe, and we want to ensure they are not promoted to young people as a gateway to tobacco.  But we do not agree that they should be classified as medicines because this will increase costs and, in many countries, severely restrict their availability.

It should not be made more difficult for smokers to buy e-cigs than tobacco cigarettes.

Most of the suggestions for changes received call for the requirements I propose on e-cigs manufacturers to be REDUCED.  It is argued, for example, that we should not restrict advertising if it encourages smokers to move away from tobacco.

However, if we are to secure a large majority in Parliament for an alternative to medicinal regulation we must address the issues which concern many MEPs, so I maintained the restrictions.

We vote in Strasbourg on the issue on October 8. We should not miss the opportunity to curb the world’s single-most-harmful addiction.

With regards

Frederique Ries,

Shadow of the ALDE group on the  Tobacco Products Directive

My personal view… is that this is huge progress on where we were in February – not just in terms of text, but particularly in terms of real awareness and support for e-cigarettes amongst legislators, and recognition that . Many allies in the Parliament – I’m thinking of Chris Davies, Rebecca Taylor and Martin Callanan have done a great job in pressing this case having listened to their constituents. However, I do not think this amendment is a great credit to the European Parliament overall. It is mainly good by virtue of not being terrible. It is the sort of policy-making that emerges when everyone is involved but no-one is responsible – and Ries’s note reflects that.   And that, I’m afraid, rather well describes the European Parliament and the EU more broadly.  It takes enormous efforts to penetrate the insular world of the Brussels hive with its lobbyists and interest groups, and even more to reach its monstrous outpost in Strasbourg.

What next? If this passes on 8 October, it’s not over… there has to be reconciliation with the Council.  This is done through a process called ‘trilogue’ (the third party being the Commission), which aims to find consensus between Parliament and Council in time for new amendments to be presented at the Council first reading (likely 10 December)..  Some member states who don’t support medicines regulation and have been hectored into it by others may feel emboldened and break cover and new interesting politics might yet emerge.  On October 9th, campaigning focus switches to the member state governments. This could set in train a process of actually doing what governments should do – working out how to regulate these things properly. On the other hand, there may be a effort to add in further restrictions and to make the Parliament’s alternative to medicines regulation unworkable. In that case, options will include moving to outright opposition to the directive with a view to stopping it and starting again with a new Commission, Parliament and Rapporteur, and of course legal action to protect the rights of people and economic actors harmed by capricious unlawful legislation.

Diary note: – on 8th October the debate starts and 09.00 and voting at 12.00, with a press conference at 14.00 – all Strasbourg time.

47 comments to Everyone is involved but no-one is responsible – amending the tobacco directive

  • mav

    “Avoid thresholds in nicotine density such as 30mg/ml. These limits provide no meaningful protections, but they do mean more heavily addicted smokers have to work harder to get a satisfactory experience from an e-cigarette, thus making switching less attractive to one of the most at-risk groups. The result would be a black market in stronger liquids, more home mixing and more smoking.”

    The problem with these legislators is that they seem not understand that nicotine is a self-limiting substance. Unlike other substances such as alcohol, it is not pleasurable to have too much nicotine in one’s system. Firstly, vaping at high nicotine concentrations produces an overwhelming throat sensation during inhale. Secondly, too much nicotine in the blood stream causes you to become very lethargic. Your thoughts become hazy, and not in a good way, but in a very confusing and annoying way. If the throat hit does not repel you, then the headache most certainly will.

    Legislators need to be educated on the simple concept that it is very difficult for a person to overdose on nicotine, unless their intent is actually to harm themselves.

    That being said, there is a need for limits on nicotine concentrations, however 30mg/mL is far too low. In addition, those concentrations above certain limits shouldn’t require a medical authorisation, they should require a poisons authorisation.

    I have never heard of any person vaping above 45mg/mL, and often those that vape at this concentration vape at very low voltages, such as on a 3.3V cigarette-lookalike (e.g NJOY) where the rate of nicotine being vapourised by the atomizer is very low.

    ECITA has been arguing for a 50mg/mL (5%) limit for as long as I’ve been following this. This is a reasonable limit and some might consider to be a compromise from the current UK limit of 75mg/mL.

    We need to begin treating nicotine with a little more respect. Nicotine at concentrations approaching and above 100mg/mL can be dangerous not only to the person handling the solution, but to others in the event of mishandling. Even as a DIY ejuice mixer, I strongly believe that there should be strict poisons licencing to regulate the purchase and handling of nicotine above 100mg/mL. Personally, I believe the retail sale of all nicotine liquids above 100mg/mL should be out right banned.

    For nicotine concentrations between 50mg/mL and 100mg/mL, I believe a low cost poison handling licence should be required, even for us DIY mixers. It shouldn’t be a complex or costly process to acquire such a licence, and it most definitely should never be considered medical. What we do need however is small road block in the purchasing of nicotine between 50mg/mL and 100mg/mL. A non-tedious stop-sign to say; “mate, before you purchase this nicotine, are you sure you know what you’re buying and how to handle it?”. This would be mostly to deter those people who are not serious about DIY vaping.

    I believe the reason why legislators want to medicalise high nicotine concentration liquids is because they are under the misconception that it is pleasurable to consume excessive amounts of nicotine.

    They need to educated on the fact that it is not pleasurable to consume excessive amounts of nicotine. However, nicotine at higher concentrations do represent a hazard for those not knowing how to handle it and those around them. Even as a DIY ejuice mixer who regularly uses 100mg/mL to mix eliquids, I have no problem with paying a small fee for a poisons handling licence to do purchase my high concentration nicotine liquids.

    tl:dr –

    nicotine liquids under 5% – no licence required.
    nicotine liquids between 5% and 10% – low cost poisons handling license
    nicotine liquids above 10% – retail sales should be banned
    no medical licencing should ever be required for nicotine.
    Educate legislators on the fact that no one consumes nicotine at very high concentrations, as it is not pleasurable to consume excessive amounts of nicotine.

  • […] parts to it. Most notably, the limit has been raised, but to 30mg/mL. Read Clive Bate's take on it here. Read the amendments here. So, if I was going to move to Europe and continue vaping, I would […]

  • Dodderer

    I know there are more important issues here but one anomaly is that we may end up with a TPD regulated 29mg/ml ecig sitting on a supermarket shelf next to a medicinally regulated one of 31 mg/ml.They could be identical and made by the same company

    The 29 mg/ml label says
    “This product is intended for use by existing smokers. It contains nicotine which is a highly addictive substance”

    and the 31mg/ml one says(adjust for specific NRT)

    “When you stop smoking, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine.
    When you apply a nicorette invisi patch to the skin, nicotine is released and passes into your body through the skin. The nicotine released is sufficient to relieve the unpleasant nicotine withdrawal symptoms. It will also help to stop your craving to smoke but will not give you the “buzz” you get from smoking a cigarette.
    The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine. ”

    The 29 mg/ml ecig is more highly addictive than the higher strength one?

    “E-cigarettes expose the artificial boundaries placed upon ‘good’ and ‘bad’ nicotine and their hostile reception needs to be understood in relation to this. They also challenge the equation between addiction and harm, suggesting the potential for nicotine addiction without the harms of smoking and many of its pleasures. By unabashedly foregrounding pleasure, these products contest its construction as the ‘enemy’ of public health and make explicit the moral underpinnings of contemporary notions of health, disease and addiction.”

    http://www.e-cigarette-forum.com/forum/m…ction.html

  • LVD

    The TPD is not about public health, it is about protecting and stimulating tax income from tobacco products. Governments have been noticing a serious fallback in the tax income of tobacco and this was not intended, surely not in times of financial crisis. Three main reasons for this: the black market, tax evasion trough the internet and people actually quitting smoking. So a track and trace system is put in place to tackle the black market, restrictions on cross border distance sales to deal with the tax evasion issue and banning everything that has a strong track record to make people quit smoking like snuss and the e-cig. Topped of by giving the commission unlimited power to change and tweak all this at will. This is already 90% of the TPD. The other 10% is pure make-belief that printing the message “SMOKING KILLS” in font size 56 instead of font size 48 will reduce the number of cigarettes smoked; and since known to be totally ineffective in that regard it will preserve tax income.

    The protest about the ban on e-cigs however is to strong so the commission went to the fall back position: introducing a quit-smoking-tax to make up for the loss in smoking taxes. In that regard it makes perfect sense to submit the e-cig to the same restrictions to tackle the future tax evasion through the internet; a rather strict limit on nicotine level should be introduced to avoid tax evasion by buying strong levels and mixing them down;… It all makes sense with the idea of a quit-smoking-tax in mind to punish people if they actually quit smoking and thus quit paying smoking-tax.

    Don’t forget the treaty of Madrid states the European parliament are the muppets of the Euro-commission who acts on behalf of the European council of governments. The amendments are good because they avoid total disaster. But it is obvious that the introduction of a quit-smoking-tax will not be in the interest of public health and will cost many lives. It is the task of the EU-parliament to protect the EU-citizens; also against governments and ministers who kill for money. On the latter the parliament failed miserably, indeed nothing to be proud off. But first a ban to use the e-cig in public places needs to be put in place to send out the message to the uninformed public ‘same danger = same tax’ is a fair concept. The cherry on top of such a ban would be this stigmatises those ex-smokers as bad as is does to smokers; so in the future those ex-smokers will shut up nicely instead of behaving like a annoying brutal lobby. Wrong again: it will not work to blame people they stopped and no longer are an excessive burden to the health care system as well as to their personal environment. We are vaponimous and the battle continues…

  • Dodderer

    This is the amendment(no. 68) to Article 16 approved by the ENVI committee in July

    “1. Member States shall prohibit retail outlets established on their territory from engaging in cross border distance sales.”

    Frédérique Ries has included this in her proposed NCP amendment

    (j) cross-border distance sales of nicotine containing products are regulated in accordance with Article 16;

    Clive – could you have a word with them, please

    • LVD

      Amendment 68 to article 16 is a ban on international (internet) trade. But where do you draw the line between cross border distance sale (internet) and cross border proximity sale (hopping on the ferry to buy on the mainland). This smells like discrimination and in my opinion will not hold up in court. Original article 16 is an elaborate way to impose a de facto ban on international trade. What’s the difference? At least the amended article 16 has the merit to be honest about it, and leaves no doubt about the true intentions. Consumers in the EU are not free to buy their goods where they want, they have to do this locally in the shop around the corner and fund the local tax-machine. The free economic market without a free consumer market, trying to bypass the first law of economics stating there is a direct relation between supply and demand. Everyone in human history who ever tried to bypass that economic law crashed and burned. “It’s the economy, stupid” (Bill Clinton).

    • Peter Stigaard

      I agree with “Dodderer” and “LVD” – the European market has definitely shrunk, with the introduction of Amendment 68 to article 16 – leaving no option to buy nicotine containing liquids from other countries than your own.
      It is also stated in the TPD, that any member state is allowed to put stricter regulation forward in their respective countries (this is particularly relevant in Denmark, since nicotine is already classified as medicine, and can’t be sold without a costly MA for each product placed on the market) – and that means that in the future we in Denmark can’t buy nicotine containing e-liquids from other European countries, as we can legally do at the present by import. The Danish health minister has already stated, that she can’t see any need for changing the Danish legislation regarding nicotine containing products – and with the last option of importing NCP’s from abroad – we’re left with zero-nic liquids in Denmark, the black market or reverting to smoking “the real thing” again.
      The labour/socialist government in Denmark has no reason to change anything – since the Danish smokers are funding the more and more empty coffers of the state.
      Amendment 170 is probably as “good as it gets” – but there is still room for improvement. The limitations on advertising, sponsorship, audiovisual commercial communication and product placement for tobacco products is another issue, that the ALDE/ECR/EPP-groups should consider. If Nicorette et al are allowed to advertise their product – why shouldn’t vaping be allowed to be promoted in the same way? In Denmark all the city buses, windows of pharmacies/supermarkets a.s.o. are covered in adverts for NRT’s – just to let people know, that they are the ONLY alternative to smoking in public in Denmark. Gums, lozenges, inhalers, band-aids and mist-sprays are been pushed and promoted like “the second coming of Christ” in Denmark. In every commercial break on TV there is at least one commercial for NRT’s – portraying the smokers as stupid/non-intelligent people that just hasn’t got a spine or the will-power to quit … and why should they quit? For some time there has been some debate about “who still smokes” – and the result of that debate was, that most smokers are un-educated, on welfare, simpleminded (they dare not use the word stupid) unintelligent and probably they have mental problems as well.
      Being a vaper, I’m confronted daily with “dumb-smart” remarks from those who pass by me saying: “It’s just as dangerous as regular cigarettes”, or: “You can’t smoke in here – go outside with the other smokers…”
      Those remarks makes it so much easier to just continue smoking regular cigarettes – at least smokers are not (at the moment) the focus of everybody’s attention. Being a smoker in Denmark has been made so much “easier” since the introduction of e-cigarettes, and the press/media isn’t helping a lot. Daily we can read, that nobody knows anything about whats in e-cigarettes, nobody knows the longterm effects of using e-cigarettes – but everybody is warning about using them… so why switch?
      The idea of “quit or die” is alive and kicking in Denmark. There is a media black-out at the moment on anything that has to do with the TPD, vaping, nicotine, the free choice of switching to a much less harmful product, and especially the contents of the TPD. It will come as a shock to most smokers come 2017, when they realise that menthols are no longer being sold – and that e-cigs/e-liquids are still only available without nicotine.
      So – in conclusion, the ALDE/ECR/EPP group might want to have a word with the Danish MEP’s – and find a solution for “the Danish problem”…

  • Jonathan Bagley

    I disagree with mav on the need for any further restriction on the purchase of nicotine solution and I’m surprised if ECITA is in fact in favour of a 5% limit. The UK Government long ago, before the invention of the ecig and before this became a political issue, decided that 7.5% was a safe limit. It is only because of nicotine’s association with smoking and the constant propaganda of the anti tobacco industry that we are drawn to to thinking we need new regulations. People have for decades survived with bleach in their cupboards, nail varnish remover on their dressing tables and weed killer in their garages.

    I think agreeing to a 30mg (3%) limit will make it more likely that eliquid is eventually only sold in sealed bottles. It effectively bans home mixing and will, I estimate, at least double, probably triple the cost of ecig use. I mix my own liquid from 5.4% solution and 20ml costs me around £2.50. After having had to pay extortionate tobacco tax for the last 35 years, I have no intention of paying more than I need to for eliquid and I, like many others, will soon be stockpiling three years’ supply of 7.2% nicotine solution.

    • mav

      “It is only because of nicotine’s association with smoking and the constant propaganda of the anti tobacco industry that we are drawn to to thinking we need new regulations.”

      While this may be true of the anti-tobacco groups, my reasons for wanting further regulations on nicotine solutions stems from my own views on the safety of nicotine handling.

      As I mentioned, I use 100mg/mL nicotine solutions sourced from the US to mix my e-liquids. I, as I am sure you are, am very confident with handling and mixing nicotine liquids at such concentrations. However, the use of e-cigs and e-liquids is going to grow exponentially, and I don’t like the thought of millions of new and inexperienced vapers experimenting with a poison at such concentrations, completely unaware of the dangers it has, not only to themselves, but others around them.

      The market is still relatively small, and DIY e-liquid mixers such as yourself and I who are confident and knowledgeable about nicotine solutions, unfortunately, don’t represent the future of the vaping population.

      I think there is room for responsible and reasonable regulation on the purchasing of nicotine concentrations between 50mg/mL and 100mg/mL. I don’t think it is much to ask of us DIY e-liquid mixers if all that was required to purchase nicotine at those concentrations was a one-time £20 licence fee, especially if it deters those new vapers who are not fully aware of what they are purchasing.

      I think for public safety, new vapers should be encouraged to begin on premixed flavoured e-liquids. The amendments put forward by Frédérique Ries, Rebecca Taylor and Chris Davies will be be perfect for helping the majority of smokers to switch over to e-cigs in the coming years.

      Over time, those new vapers can decided if they wish to apply for a low-cost nicotine handling licence, and purchase e-liquids at much higher concentrations.

      I’ve seen smokers turned off by the very thought of mixing their liquids. So in the end, I think in the future, DIY e-liquid mixers will be a small minority of the vaping population. However, I completely support the availability of DIY nicotine concentrations (50mg/mL-100mg/mL). I just feel that a small road block is required to deter new and inexperienced vapers from straying away from premixed e-liquids too quickly. A low cost poisons handling licence would be ideal for this.

  • Sebt

    Thank you, both for your efforts in contributing to getting us this far, and for your informative analysis of where we stand now.

    My feeling is similar to yours: that there’s good and bad. The bad:

    “d) the unit packet of nicotine containing products includes a leaflet with
    instructions for use, including that the reference that the product is not
    recommended for use by non-smokers, contraindications, warnings for specific risk groups, reporting of adverse reactions, place of manufacture and
    contact details of the manufacturer or importer;”

    This I can see being a right pain. I buy e-liquid in quantities of e.g. 30ml per flavour at a time. Often the supplier delivers this as 3 10ml bottles, because that’s what they have in stock. Does every bottle really have to carry this giant folded tome? (Take a look at a 10ml bottle, and you’ll get the idea). I suspect that – as usual – the MEPs are uninformed, and imagine that e-cigs come in packs of 20, like cigarettes. So how about packaging the warning leaflet with the hardware? Nope, that won’t work either. I could buy a battery (reasonably bulky), and an atomiser (tiny) separately and make myself a PV. This is in fact what I do, as the parts wear out and need replacing. Should both these components carry a gigantic leaflet?

    My initial thought is that, in this very much web-based market, in 2013, the purpose of including full, unabridged information in printed form, on such small products, could be perfectly well covered by a direction to a website for information. The one class of products to which I wouldn’t apply this, because of their high-risk nature, would be of course prescribed medicinal drugs. Is this an attempt to try to “medicalise” e-liquid by association? Or could it be exploited in this way in debate? (in a wedge tactic – “well, we’re treating them as dangerous medicines…”)

    I have a feeling – a very familiar feeling by now – that MEPs are, again, uninformed (to be charitable: misinformed would be more appropriate). Someone needs to explain to them that e-cig products are not something that a vulnerable old lady – with no computer or Internet connection – is ORDERED to take on medical advice, e.g. to manage a serious health problem, and without knowing everything about possible side-effects: they are elective, consumer products, which people choose to use in an informed way.

    “(i) the limitations on advertising,sponsorship, audiovisual commercial
    communication and product placement for tobacco products as set out in
    Directive 2003/33/EC and Directive 2010/13/EC shall apply to nicotine
    containing products;”

    Again, not ideal, given the clear difference (in terms of public-health effects) between tobacco and e-cigarettes. I can’t claim familiarity with those directives: but might this e.g. prevent on-line retailers from effectively advertising their wares, even behind the usual “I am 18: ENTER/I am under 18: LEAVE) gateway?

    “(j) cross-border distance sales of nicotine containing products are regulated in accordance with Article 16;”

    Definitely not keen on this. Both because it blurs the distinction between cigarettes and e-cigarettes, which you (and all of us) are trying to get lawmakers to grasp; also from a practical standpoint. I haven’t researched it thoroughly, but a Hungarian friend told me that the Orbán government have gone ahead with their own prohibition of nicotine-containing e-liquid, ahead of any European measure; meanwhile, the best information I have is that cross-border purchases for personal use are likely to be tolerated there at present. This provision would change that. I know that Orbán, being Orbán, is not likely to pay much attention to anything from the EU – but this provision only needs to be effective in _other_ EU countries for vapers in Hungary to be unable to get hold of e-liquid. (Thank you, MVD, for the clarification on Article 16).

    As has already been pointed out, there is no sense in which the inclusion of e-cig products into article 16’s cross-border restrictions can make sense – unless with the intention of raising tax on them (on an individual member-state level) in the future.

    If I may ask a procedural question to Clive: what can we do? Is it worth trying to contact MEPs and push for amendments to make this amendment slightly better? Or has some kind of deadline passed, so that no further amendments are possible and the best course of action is simply to urge support for this – imperfect – amendment?

    Thanks again!

    PS: to MAV – excellent, clear comment BTW:

    “nicotine liquids under 5% – no licence required.
    nicotine liquids between 5% and 10% – low cost poisons handling license
    nicotine liquids above 10% – retail sales should be banned
    no medical licencing should ever be required for nicotine.”

    Since we’re dealing with a group of not well-informed people, who are having sixteen flavours of nonsense blown into their ears (at a concentration of 1000mg/ml) by lobbyists, it might be better to express this in terms of mg/ml. You and I know that 5% = 50mg/ml, 10% = 100mg/ml. They might not. Let’s not open the goal to some moron shrieking “OMG! Vapers vape 50% NICOTINE legally!” when it’s actually 50mg/ml.

  • Dear Friends!

    This amendment gives hope for thousands of vapers and 2,5 million smokers in our country, where a seriously sick government serve political power for Big Pharma and Big Tobacco. Please do not forget that HUNGARY is not free! Thanks for all people working on an acceptable e-cig regulation in EP!

    István Zentai

    • Sebt

      Hi István

      Do you have details on what the current (or soon to be current) law is in Hungary regarding e-cigarettes and nicotine-containing e-liquid? I haven’t managed to find the exact facts (and my Hungarian is not good enough to search for and read the actual legislation).

      thanks

      Seb

      • Dear Seb,

        The main concept of Hungarian authorities to DEFINE e-liquid as a medicine. Someone listed “nicotine” in Hungarian Book of Phermaceutical Components.

        However, Hungarian code of medicine is just the same as say in Germany, yet, governmential asserts that ANY PRODUCT counts as medicine which is containing nicotine, AND other law do not say anirging else.

        THIS IS HUNGARY: ANITHING IS FORBIDDEN WHAT IS NOT ALLOWED.

        After this, selling, manufacturing or producing nicotine e-liquids is drug counterfeiting. It is ridiculous, of course.

        Hungarian Criminal Code (valid from 1st of July 2013):

        186. § (1) Aki

        a) egészségügyi terméket meghamisít, vagy hamis egészségügyi terméket készít,

        b) hamis, meghamisított vagy Magyarországon nem engedélyezett egészségügyi terméket kínál, átad, forgalomba hoz, vagy azzal kereskedik,

        c) hamis vagy meghamisított egészségügyi terméket az ország területére behoz, onnan kivisz, azon átszállít, vagy indokolatlan mennyiségben megszerez, tart,

        d) Magyarországon nem engedélyezett egészségügyi terméket indokolatlan mennyiségben megszerez, tart, az ország területére behoz, onnan kivisz, azon átszállít,

        e) egészségügyi termékhez kapcsolódó eredeti dokumentumot kereskedelmi céllal rendeltetésétől eltérően felhasznál,

        bűntett miatt három évig terjedő szabadságvesztéssel büntetendő.

        (2) A büntetés az (1) bekezdés a) és b) pontjaiban meghatározott esetekben

        a) egy évtől öt évig terjedő szabadságvesztés, ha a bűncselekmény maradandó fogyatékosságot vagy súlyos egészségromlást,

        b) két évtől nyolc évig terjedő szabadságvesztés, ha a bűncselekmény halált

        okoz.

        (3) Aki az (1) bekezdésben meghatározott bűncselekményt

        a) egészségügyi dolgozóként,

        b) gyártásra, nagykereskedelemre, közvetlen lakossági ellátás végzésére engedéllyel rendelkező szervezet alkalmazottjaként, vagy

        c) bűnszövetségben

        követi el, egy évtől öt évig terjedő szabadságvesztéssel büntetendő.

        (4) A (3) bekezdés szerint büntetendő, ha a hamis, meghamisított vagy Magyarországon nem engedélyezett egészségügyi termék a felhasználók számára széles körben válik hozzáférhetővé.

        (5) E § alkalmazásában

        a) egészségügyi termék: a gyógyszer, az állatgyógyászati készítmény, az orvostechnikai eszköz, az in vitro diagnosztikai orvostechnikai eszköz és a vizsgálati készítmény;

        b) indokolatlan mennyiség alatt olyan mennyiséget kell érteni, amelyről megállapítható, hogy nem valamely meghatározott személy személyes szükségleteinek kielégítését célozza;

        c) Magyarországon nem engedélyezett egészségügyi termék alatt érteni kell a megfelelőség értékelési eljárás lefolytatása nélkül forgalomba hozott orvostechnikai eszközt is, továbbá azt a terméket is, amelyben gyógyszerhatóanyagot az adott termék összetételére vonatkozó jogszabályi előírások megsértésével használnak fel. Engedélyezett egészségügyi terméknek kell tekinteni azt a magyarországi forgalombahozatali engedéllyel nem rendelkező gyógyszert is, amelyre nézve olyan az (1) bekezdés b) vagy d) pontjában meghatározott magatartást fejtenek ki, amely jogszabályban előírt hatósági engedély birtokában vagy bejelentést követően jogszerűen végezhető.

      • Sebt

        Hi István

        Thank you for the information. My head hurts from trying to translate it – I need a vape! Please correct me if I’ve mistranslated anything – I am certainly not skilled in legal Hungarian.

        According to my attempt at translation, paragraphs 1-4 seem quite sensible, IF applied to potentially dangerous medicines. The craziness is the classification of nicotine as a pharmaceutical, making it a “healthcare product” under 5(a).

        This, in turn, makes producing it, importing it, or even buying or possessing it in an “unauthorised quantity” a crime under severe legislation which is aimed at the serious crimes of adulterating or counterfeiting pharmaceutical drugs. The maximum punishment, if I understand correctly, is 3 years in prison, rising to 5 years if the crime makes the (“adulterated, counterfeit or unlicensed”) product “widely available to end-users”. (4. “a felhasználók számára széles körben válik hozzáférhetővé”).

        Of course this seems reasonable if the product in question is a counterfeit or adulteration of a powerful, potentially harmful medicinal drug: but the craziness, again, is in bringing nicotine under this regime.

        As far as I can see there’s nothing about nicotine in what you quoted: the connection must be in a different place (the listing in the Pharmaceutical Book of Components, that you mentioned) which defines nicotine as “gyógyszer” – medicine or pharmaceutical – and thus brings it under this law through 5(a).

        What incredibly bad legal practice! It makes me wonder how cigarettes can still be legal in Hungary: because they’re not licensed medical products, but they contain nicotine! It’s especially ironic that paragraph (2) specifies harsher penalties (up to 8 years) if the crime causes actual severe damage to health, or death – but that nicotine is subject to this law, even though it does neither of these things.

        I think this demonstrates something I’m always afraid of with regard to legislation and headline-grabbing propaganda: bad propaganda, lies in debate and bad legislation in one place (e.g. the EU or the WHO) trickle out and down, causing even worse propaganda, lies and bad legislation elsewhere.

        Strangely, there is an exemption applying only to acquiring or possessing the product in question, which is the “unauthorised quantity”. I’m not sure what the precise definition of this is ( 5b: “amelyről megállapítható, hogy nem valamely meghatározott személy személyes szükségleteinek kielégítését célozza”), but it seems to amount to something about enough to meet your personal needs – though it’s very unclear who decides this…

        If I’ve understood this last part correctly, it’s (slightly) good news for vapers visiting Hungary (when I entered Hungary from Ukraine, Customs were only interested in cigarettes). But the law is a disaster for vapers in Hungary, who need to supply themselves.

  • LVD

    The best thing we can do is to support this amendment for the sake of all EU-citizens but clearly state we do not agree with all the ‘guilt by association’ arguments in it, which only make sense if a future quit-smoking-tax will be put in place. And we should refer to this as the “quit-smoking-tax”, not much more arguments are needed to convince of the cheer madness of it. However this battle will be fought on a national level, and we will see which EU-governments are so addicted to taxation that they even tax people for quitting smoking and to make up the loss of smoking-tax, this to be the public shame to the rest of the member states and to the rest of the world.

  • TheInvisibleHand

    My question is simple: If nicotine is to be classified as a medicine, is it legal to deny people the right to “Take their medicine” where ever they need to?

    • LVD

      It is only safe to vape in public above 30mg/ml nicotine; below that treshhold there is as much danger to second hand vape as there is to second hand smoke; so the same public bans and same sin-tax should apply. Then again two people vaping simultaniously at 18mg/ml equals one person vaping at 36mg/ml and can do so in public and are expempt from tax (ROFL). Do not try to find any logic in the tax addition of politicians.

  • Rotax

    The problems with amendment 170 are the 30mg/ml nicotine concentration limit which is too low for DIY mixing and the ban of cross-board sales. I am from Finland where nicotine is classified as medicine and therefore all Finnish e-cig users import their nicotine containing liquids from EEA. Banning that possibility to buy liquids will implement also effective ban for users. Personally I like more of the amendment 135, which does not contain those restrictions, than this one. 135 is supported by ALDE and ECR.

    • LVD

      Of course we like 135 better; 135 was well though of, consistent, intelligent, in short… Ries-like. It only needed to brush up in some unfortunate choices of 2 or 3 words. In my opinion all the added nonsense to it in order to transform it into 170 is after informal consultation with either the commission or the council. They want to push this TPD trough in first reading before the Greek presidency of the EU.

  • Roger Hall

    I find the 30mg/ml limit frustrating. Either e-cigarettes with nicotine are or are not a medicine? The fact that the nicotine level is going to determine if an e-cig may or may not be classified as a medicine defies logic as if a 29mg/ml isn’t medicinal and won’t require a MA what changes with a 31mg/ml strength? It’s akin to saying that half an aspirin tablet isn’t a medicine but a full tablet is. How can nicotine therefore be a medicine? I’m wary of the precedent that this sets by inferring that the definition of a medicine and if a MA is required will be determined by the level of nicotine and a relatively low one at that.

    Advertising has to be allowed as all the evidence points to e-cigs being quantifiable safer than tobacco cigarettes and this should be allowed to be told to EU citizens, as otherwise how are they going to be educated?

    Finally cross border internet sales are a crucial aspect of EU free trade. The clause just allows a potential back door sovereign state taxation to be placed on e-cigs that could make them unattractive to smokers, who could then revert to tobacco for fiscal reasons. One of the appeals of e-cigarettes is the fact that it is cheaper than tobacco cigarettes in most EU countries.

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  • Rotax

    This amendment 170 sounds like tailor made for Big T’s products. No internet sales but sales in B&M shops is allowed. Only Big T can provide products in that quantity and small vendors who sell their products on internet vanishes.

  • Andy Morrison

    Excuse my ignorance in these matters, but i’m sure there are many in my position who just want to know what is really going to happen if amendment 170 to the nth directive of the tobacco article 18 section c subsection 4b which references article 31 of the you’re not allowed to do that rule.

    From what I can see, I will no longer be able to buy the flavourless 54mg nic base that i used to buy, but i can buy a 30mg equivalent – ok, I can live with that, even though it’s daft and will cause difficulty with DIY.

    What about buying stuff on the internet? Can someone explain? Will I still be able to order online from UK, USA and/or China?

    What about the devices themselves? Will I still be able to buy them online?

    All in all it looks like a cop-out to me, but if its the best we can get, then go for it.

    Sorry to be a pain in the butt if it is clear to everyone else bar me.

    • Dodderer

      Anything above 30mg/ml will need a medicines licence – unlikely any supplier will go down that route given what the MHRA have proposed re licensing liquids.

      The Commission’s proposal for cross-border etc sales was just registration of details – the ENVI report included an amendment to ban all cross border sales.

      I don’t think Amt 170 intended this so I hope there will be some adjustments made.

      I think the devices are untouched – whether that’s the intention, I don’t know. I don’t think they understand that all ecigs are not one-piece lookalikes – let’s keep it secret!

  • LVD

    Amendment 135 was a genuine good piece of legislation in the making, but has been reduced to amendment 170 by outrageous greed and a total lack of care for people which are much more the trademark of people like commissioner Borg than the MEP’s we have learned to appreciate over time. It is a real shame to see legislation having to steep to such a low level in order to stand a chance of getting EU approval. Surely not the EU I would like to see more of it; less would be better. Sincerely disappointed, but then again not, I really didn’t expect any better coming from whom it came from.

  • Karl Nørgaard

    If it’s right amendment 170 prohibits cross border sales on internet, it would be very bad for many european citizens as it gives each country an easy opportunity to stop the spread of e-cigs. Not by arguments about health, or by classifying it as a medicine, something we could at least go to court with,but by simply putting a tax on nicotine juice and make it more expensive than smoking.

  • toni

    Im afraid 170 will be as good as a straightup ban here in Finland. Sales across borders must not be prohibited, its against everything that EU is supposed to stand for.

    • Clive Bates

      Don’t forget it isn’t the end of the story… it is like taking territory in a battle. If we get this we move to a new phase on 9 Oct. If not, we are dead and it is medicines regulation.

  • LVD

    I don’t thing the Chinese are going to be bothered by this and keep on sending little yellow envelopes labeled “Gift from uncle Chang, value 10$”.

  • mattdidius

    Under the logic of the TCD airbags should be restricted because they encourage drivers to speed

  • LVD

    Preservatives should not be used to prevent Aids since total abstinence from sexual relations works better. The editer of “60 million de consomateurs” in France is still proud he did contribute to this idea, and now he’s even more proud to do the same with e-cigs. There’s strange creatures walking this planet.

  • LVD

    That was his defence towards Aiduce: back in time 60mc did publish preservatives were permeable and were not effective to protect against Aids, this was also reveived with a lot of protest by Aids campaigners. But thanks to 60mc to warn us about this preservatives changed and became impermeable in the meantime, so we should be thankfull to them….

    Just like e-cigs will become less dangerous in some distant future probably by that same miracle worker who changed the physical properties of latex…(ROFL)

    Strange creatures indeed.

  • Margaret Hermon

    Totally agree with Clive Bates. Let’s get rid of the medicalisation idiocy – anything else would, presumably, be open to negotiation, horse-trading, whatever. Those of us who have been involved since before last Christmas are so aware of how far we have come, and how much effort has been involved – even a few weeks ago this amendment would have seemed a bit of a pipe-dream (sorry!)
    It isn’t perfect, few things in life are, but it’s do-able and a good spring-board. It’s useless to put forward a proposal or an amendment if it is obvious that support for it would fall short of the mark.

  • [email protected]

    Where did the 30 mg/ml number come from? It seems (surprisingly) high ti me.

    Thanks!

  • mav

    I’m surprised BAT and NJOY have not complained about this.

    BAT’s Intellicig and Vype’s Full strength range is 45mg/mL ecig. NJOY’s Bold range also exceeds the 30mg/mL limit at 45mg/mL. Without the high nicotine content to compensate for the low voltages that their ecigs run at, they’ll lose a significant share of their European customers.

  • […] Clive Bates has very eloquently put forward reasoned debate on the matter and he raises some excellent points on why e-cigs should be regulated as recreational consumer products and nothing else. […]

  • […] (but can be improved upon) while there are threats in the UK from the big pharm dominated MHRA. Clive Bates, former director of Action on Smoking and Health, has argued that the amendment that was passed […]

  • […] Frédérique Ries (supportive in ALDE but in favour of heavy restrictions); […]

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