Totally Wicked to challenge Article 20 of the TPD – a vaper’s view

In June 2013, when the UK MHRA announced that e-cigarettes would be regulated as medicines, the idea that anyone was going to destroy the very industry that had provided me, and millions of others, with an attractive and very much safer alternative to smoking, jarred me into action – and so I found myself in the increasingly frustrating world of consumer based vaping advocacy.

I had never been an advocate for or against anything much before and so found myself pretty much out of my depth most of the time. Public Health ‘science’ relies a lot on epidemiology and nebulous concepts such as gateway theory and the precautionary principle, and I quickly learnt that it is a field full of people who, not content with simply presenting the results of their studies, proffer political solutions to their perceived, and often contrived ‘problems’ as well. And more than that – there are those who, because of the letters behind their names, seem to be permanent invitees to comment on both press articles and TV and radio coverage, and who think nothing of using their twisted analyses of those studies to further their own political agenda. They never seem to consider the inherent risks to current vapers and smokers who may have switched in future in the event that their political aspirations were to be successful.

It was against this background that vapers in their thousands signed petitions and wrote to their MEPs in the latter part of last year. The European Commission, presumably at the behest of the governments which make up the Council (who in turn take their advice from the aforementioned Public Health lobbyists), had produced draft legislation which, if passed, would have required the Parties to regulate e-cigarettes as medicines (article 18 applied to e-cigarettes and later emerged as article 20). Article 18 was defeated in the European Parliament in December 2013, when MEPs, having listened to their constituents, voted for amendments which would allow most e-cigarettes to be regulated as consumer products. Unfortunately, during the ridiculously undemocratic (but leaky) process of ‘trialogue’ further amendments were agreed (now in article 20) which were basically a total compromise.

But compromise is rarely the right answer when you are talking about the health and right to chose of millions of people. What of those whose preferences are excluded by the arbitrary and restrictive measures of article 20 of the TPD? What about those businesses which will disappear, not because their products are sub standard or dangerous, but simply because they lack the resources to comply with the utterly disproportionate reporting requirements? What are they, just collateral damage? And if so, who are the beneficiaries of their loss? There is only one answer to the latter question – the tobacco industry, whose core product is not subject to anything like the same barriers to market and who as a result will welcome the return of many vapers to smoking with open arms.

The regulation of e-cigarettes could have been so much better. They are neither a medicine nor a tobacco product and framing them in the context of either was a mistake. Bespoke regulation could have had the effect of improving quality, raising awareness of the safer choice, providing a good level of information and confidence to the consumer and weeding out the cowboys whilst regulating marketing proportionately. Instead we have a mish mash of arbitrary limits and reporting requirements which will do no more than stifle innovation, limit consumer choice for no reason and ultimately inhibit the very appeal that has lead 2 million people in the UK alone to make the switch. The tobacco industry must have breathed a collective sigh of relief.

Consumers have been making these arguments for a very long time. So have the e-cigarette industry, however in the Public Health arena they are persona non grata. In the minds of some in the Public Health world it is simply not possible to be in business and at the same time care about the health and well being of your customers. Based on past performance this may be true of the tobacco industry, and it is true that that industry has recently bought in to the cigalike sector, however the TPD will barely affect their products. It will however decimate the refillable tank sector. Strange then, that that is the very sector that provides the products which most total switchers use and is comprised almost exclusively of companies independent of the tobacco industry.

Last week large independent e-cigarette company Totally Wicked leapt into the arena with the announcement of their legal challenge to article 20 of the TPD. Totally Wicked have long been a company that is not afraid of taking the bull by the horns, and certainly doesn’t shy from controversy, sometimes to their own detriment. Here is their press release: Totally Wicked Formally Challenges Tobacco Products Directive

This move has upped the anti to a very large extent. On the one hand, if they are successful it could be back to the drawing board for e-cigarette regulation in Europe; but on the other, if they fail, things could be made very much more difficult for any future challenges. If Totally Wicked succeed governments could take the opportunity to press for even more products to fall under medicinal regulation, but conversely the delay will allow time for more real science to emerge and many more vapers to join the fight. It’s certainly a gamble. As a vaper, and with only a passing grasp of the vagaries of EU law, I am both elated and terrified by the prospect of the challenge that they have taken on.

Totally Wicked and their advisors will be well aware of the limited basis on which such challenges can be made, and of the fact that thousands of consumers, many of whom will be their own customers, will be watching their every move. Vapers will feel that Totally Wicked’s fight is their fight too, the interests of industry and consumers are well aligned, and both support and criticism are sure to follow in the months ahead. It will be an additional challenge for them to pursue these proceedings whilst at the same time ensuring that their customers remain informed and understand the nuances of the decisions which have to be made along the line. But the status quo is intolerable, so someone had to do it and I’m not in the least bit surprised or disappointed that it was them. I salute them and wholeheartedly support them in this challenge. One thing is for sure, exciting times are ahead.

 

Sarah Jakes, Vaper.

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Save E-cigs has written to Dr Glover asking what advice she gave in relation to e-cigarettes and the TPD.

Eurocrats twist the evidence…. Finally the EU Chief Scientific Adviser has spoken out.

We knew it went on – it was graphically illustrated when Dr Farsalinos wrote that famous letter of his which you can read here – he quite rightly points out that his work has been misrepresented.

Dr Lynn Dawkins wrote in a similar vein, but that too was ignored and the TPD when ahead – after drastic changes that were negotiated behind closed doors.

And then last week this article is published: http://www.breitbart.com/Breitbart-London/2014/05/30/Eurocrats-twist-scientific-evidence-to-suit-politcal-imperative.

Dr Anne Glover is the Chief Scientific Adviser to the EU, but it seems her advice is generally ignored. In the article she uses a fictitious example –“ “Let’s imagine a Commissioner over the weekend thinks, ‘Let’s ban the use of credit cards in the EU because credit cards lead to personal debt.’ So that commissioner will come in on Monday morning and say to his or her Director General, ‘Find me the evidence that demonstrates that this is the case.’”

The Commissioner’s staff might resist the idea but in the end, she said, “they will do exactly what they’re asked” and “find the evidence” to show that credit card use leads to personal debt, even though this may not be the case in reality.”

And even more telling is this line: “if people don’t like what’s being proposed, what they say is that there is something wrong with the evidence.”

And this is exactly what happened to e cigarettes during the Tobacco Products Directive journey. Time and again research was presented to the EU, the MEPs and those tasked with ensuring the TPD was achieved within a very tight time frame. Time and again we saw credible evidence refuted for mere hypotheses – a few ‘what if’s’ and completely unscientific scaremongering.

The article ends – to make the case succinctly “For example, the EU’s 2007 REACH policy (Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals) generated 36 different impact assessment studies, many from within the chemicals industry warning of the disastrous costs of the policy.

Yet, said Glover, “A final impact study ended up broadly confirming the Commission’s original assessment.”

One can only wonder at the information that passed the desk of the scientific advisers when it came to e cigarettes. Save E-cigs has written to Dr Glover asking what advice she gave in relation to e-cigarettes and the TPD, if and when we find out we will let you know. Watch this space.

 

Post TPD vote response.

Today MEPs had the opportunity to vote to take Article 18 out of the TPD without jeopardising the passage of the wider Directive.  This would have been the right thing to do.  It would have been in keeping with the publicly expressed views of scientists and public health experts.  It was what the overwhelming majority of responsible e-cigarette manufacturers were calling for, and most importantly of all it is what the EU’s 12 million vapers have been calling for for nearly a year.

However, when it came to the vote, MEPs voted by a whopping 478 votes to 130 votes in favour of Article 18 remaining in the TPD!  To the 130 MEPs, which included regular Save E-cigs blog contributors, Martin Callanan MEP, Nikki Sinclair MEP, and Rebecca Taylor MEP, who did the right thing, we simply say a huge thank you, not just for today, but for all your support over the last year or more.  To those 478 MEPs who vote for the retention of Article 18 as part of the TPD, we simply ask why?

Why would any right-minded politician vote for Article 18 when it is so flawed?

 

  • It is based on a misrepresentation of scientific evidence,
  • It subjects e-cigarettes to a stricter regulatory regime than tobacco cigarettes,
  • It bans e-liquid bottles exceeding 10ml in volume,
  • It bans tanks exceeding 2ml in volume,
  • It forces manufacturers to wait six months before putting new products on the market,
  • It poses restrictions on cross-border sales,
  • It bans all promotion of e-cigarettes, and
  • It bans e-cigarettes and e-liquids with nicotine concentrations above 20mg/ml.

The last point is perhaps the most important as independent research published this week by the respected economic consultancy, London Economics, demonstrated that the TPD’s ban on higher strength e-cigarettes, used by 2.5 million Europeans, will increase tobacco smoking by 9.6 million cigarettes a day and result in the deaths of an extra 105,000 people every year.

Where do we go from here?

As a campaign representing vapers, their friends, and their families, we will not give up.  We have a number of very exciting plans which we will be updating you about very soon.

For now, we will publish the full list of the 130 MEPs who voted to have Article 18 removed from the TPD and the full list of the 478 MEPs who voted to keep it in; vapers can then use it as a resource when deciding how to vote in the European Elections later this year.

 

Final vote on the TPD; what now for ecigs?

 

 

Guest Post from Rebecca Taylor MEP.

After several weeks of complicated discussions with colleagues, I was disappointed to hear yesterday that the Conference of Presidents (the leaders of the Parliament’s political groups) has not yet given the go-ahead to allow split or separate votes in next week’s final vote on the Tobacco Products Directive.

The current argument is about whether the split or separate votes should come before the single vote on the trilogue agreement or afterwards. If they come afterwards, they can only be voted in the unlikely event of the trilogue deal being rejected – so obviously they must come beforehand. I am of course working with colleagues to try to push for this. If there is the possibility to vote to remove certain parts of article 18 or reject the entire article, I will do that as will a number of ALDE colleagues.

So it is possible that on Wednesday MEPs may only have a single vote

(Yes/No/Abstain) on the entire TPD, with no opportunity to single out and remove specific parts of the text.

However, as I have already made clear numerous times, I will not vote against the Directive as a whole. Unlike some who have supported the case for sensible regulation of e-cigarettes, I also support the tobacco control measures in the directive (my voting record speaks for itself). I believe that tobacco control measures and e-cigarettes are two sides of the same coin; the tobacco control measures can discourage people from starting to smoke and sensible regulation of e-cigarettes can provide a way for smokers to quit their tobacco habit. I know that some e-cig users disagree with me about the tobacco control measures or consider them to be unimportant; there we can agree to disagree.

However, I believe that one of the key reasons that myself, Frédérique Ries and Chris Davies were able to get enough MEPs to vote in favour of the ALDE plenary amendment on e-cigarettes in the first place, is because none of us could be identified as MEPs who backed the tobacco industry line on the TPD.

This was against a backdrop of some opponents of e-cigarettes deliberately trying to blur smoking and vaping (and in fact some still are, which annoys me greatly).

So where does this leave e-cigarettes now?  Well, we must recognise that an awful lot of progress has been made compared to the initial Commission proposal, which would have seen across the board medicines regulation.

But the fact remains that there are parts of the agreed Article 18, which are far from satisfactory, and this is why the Liberal group negotiator

Frédérique Ries refused to sign up to the final deal. The problematic points include:

•   Continued option for Member States to regulate e-cigs as medicines “by function or presentation”

•    The arbitrary threshold of 20mg/ml of nicotine to be allowed in e-liquids;

•    The possibility for the European Commission to propose ban on a specific device in all Member States, if three or more countries remove it from their own markets.

This means that there is still work to do if the TPD is approved next week.

Implementation will be key and it is vital to ensure national governments take as flexible an approach to e-cigs as possible.

It is therefore necessary to keep up strong lobbying of national governments, so that ministers go for consumer product regulation of devices, which is set as a precedent by this Directive on a European level.

After reading clarifications of the technicalities involved in this

Directive provided by the Health Commissioner Tonio Borg (in response to questions from Chris Davies), I am optimistic that it would difficult for a

Member State to regulate a product under pharmaceutical rules, except where companies chose to opt for medicines regulation themselves. The wording of the article obliges governments to prove that an e-cig meets the definition of a medicinal product as set out in Directive 2001/83 EC – namely a substance must have properties for treating or preventing disease in human beings. Numerous courts across the EU have already rejected the application of this definition to e-cigs.

On the banning of devices across the EU, not only do three Member States have to prove that the devices have pose a ‘significant risk to human health’ (quite a high bar), but the Commission can only use this power through a procedure called ‘delegated acts’, which allows the Parliament to veto such a decision if enough MEPs disagree with it (and MEPs regularly reject delegated acts).

And finally, regarding the 20mg/ml threshold, this has been significantly raised from the original 4mg/ml suggested by the Commission, and the 2mg/ml put forward by national governments and, as we are told by a number of scientific experts that this will satisfy the majority of vapers, around 70% of whom use 20mg/ml or less. However, I accept that vapers who use a higher nicotine threshold may suffer unnecessarily because of this.

I understand and share consumers’ frustration and disappointment that the final text on e-cigarettes has enough caveats and loopholes to cause great concern. It is a massive improvement on the original proposal, but still not good enough.

Approx. 40,625 smokers are switching to e-cigarettes each month.

MEPs need to stay focussed on the bigger picture

In the UK each year 114,000 people die from tobacco related illnesses according to figures produced by the NHS[1].  Policy makers need to focus on reducing this number.  Conventional nicotine replacement therapies are not tackling this in any significant number, but e-cigarettes could.  Already 1.3 million smokers have switched to e-cigarettes[2].

1  

There are 10 million adult cigarette smokers in Great Britain[3] at present.  The above graph[4] depicts the percentage of tobacco cigarette smokers currently using e-cigarettes.  The graph shows an increase in e-cigarette use from two per cent to 16 per cent in 28 months.  That is a 14 per cent increase in just over two years.  Basing that figure we see that there is a 14 per cent increase over 28 months which works out as an average monthly increase of 0.5 per cent.  This means that at present 40,625 smokers are switching to e-cigarettes each month[5].

2  

Linear Trendline

The above graph (Linear Trendline) depicts the growth in e-cigarettes use on a linear trendline from the present until May 2017 when the revised Tobacco Products Directive (TPD) will come into force in the UK.  A linear trendline is a consistent average of the figures provided, a simple and best way to forecast on present results.  The graph shows an expected increase in e-cigarette use of 35 per cent by 2017.  The number of vapers will rise from 1,300,000 to 2,843,750; more than double the present number.  This means that of the 10,000,000 current smokers, 30 per cent will be using e-cigarettes by 2017 based on these projections, an increase of 1,543,750 vapers.

3  

 Polynomial Trendline

The above graph (Polynominal Trendline) depicts the growth in e-cigarette use on a polynomial trendline from the present until May 2017.  A polynomial trendline is the best for fluctuating figures with hills present in the graph data and usually based over a large figure set and an increasing growth rate.  Best represents increased growth from the data figures.  The graph shows an expected increase in e-cigarette use of 80 per cent by 2017.  That would mean there would be 6,500,000 vapers in 2017.  A staggering 65 per cent of current smokers would then be vaping.

In a worst case scenario there would be a 35 per cent increase in vapers and in the best case scenario an increase of 80 per cent.  In reality, the actual rise in e-cigarette use is likely to be about half way between these two figures – an increase of 57.5 per cent.  This would mean that in May 2017 there would be 4,671,875 individual vapers.  By contrast the European Commission predicts that at best tobacco control measures contained within the revised TPD would only reduce the 10 million figure by two per cent![6]

MEPs need to stay focussed on this at all costs as this is the real public health prize – a real and significant cut in the number of smokers.  In everything MEPs do relating to the regulation of e-cigarettes they should remain focussed on this bigger picture and not allow themselves to become bogged down in the minutia of regulation.

Article 18 of the TPD, as it currently stands, genuinely puts at risk the positive future outlined above.  We therefore urge all MEPs to support our call, to the President of the European Parliament, to have this file opened up for split and separate votes, so as to allow proper consideration of Article 18 without jeopardising the passage of the wider TPD.

Open letter to MEPs from the American trade association SAFTA

January 21, 2014

Dear MEP,

As the largest trade association dedicated to promoting education and information of personal electronic vapour (PEV) products such as electronic cigarettes, we at the Smoke-Free Alternatives Trade Association (SFATA) write to you today to express our concerns over Tobacco Products Directive and ask that you consider the facts and information we provide before rendering your decision.

SFATA represents seventy members, comprising a wide cross section of the “smoke-free” industry including distributors, manufacturers and retailers who will be hurt in different but equally damaging ways in the absence of appropriate and proportional regulation which meets the objectives of governments and public health regulators.

SFATA respectfully submits that changes made in trilogue to Article 18 render it an entirely new directive, deserving a fresh start and full review and point to the following issues in the current version of grave concern to our members:

A. Ban extension on refillable products

Depriving countless adult users of these products across the E.U. in the event that a block of any three member states eventually elects to ban them individually, would unfairly and disproportionally disenfranchise the voices, needs and contributions of businesses and consumers across the E.U. who deserve and support continued access to these technologies.

B. Consistent Dosing Requirement

Requiring that these products all deliver identical puffs would stifle the ongoing innovation that continues to drive superior and diverse products in the industry, which are designed to accommodate the customization and individuality desired by of adult consumers.

C. Limits on Nicotine Levels

Addiction to nicotine is both physical and behavioural; the proposed mandate requiring minimal amounts of nicotine ignores documented evidence that more than 20mg/ml of nicotine content is required for current smokers to successfully maintain the switch to vapour products like electronic cigarettes and is therefore inappropriate. See, Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Voudris V. “Evaluation of Electronic Cigarette Use (Vaping) Topography and Estimation of Liquid Consumption: Implications for Research Protocol Standards Definition and for Public Health Authorities’ Regulation.” International Journal of Environmental Research and Public Health. 2013; 10(6):2500-2514. http://www.mdpi.com/1660-4601/10/6/2500

D. Bans on Advertising The proposed ban on advertising censors communications so as to prevent the industry from raising awareness about vaporizers and truthfully communicating with consumers about how vaporizers such as ecigs may serve as an alternative to tobacco products. We believe such censorship would create a severe disservice to adult consumers looking for accurate, truthful and helpful information about ecigs and how they may serve as an alternative to tobacco products.

E. Cross Border Sales Ban

Vaporizer technology products are neither medicinal nor pharmaceutical products and should not be treated as such. As you know, the EU Parliament recently voted against Amendment 71 of the TPD which would have seen ecigs legislated as medical products under restricted sale. The current proposed languages attempts to similarly and inappropriately misclassify vapour products like e-cigs as medicinal products and such language should not be adopted.

SFATA remains committed to ongoing communications and constructive engagement with the European Commission and Parliament so that appropriate regulations can be created which more acutely address the unique benefits, issues and concerns raised by vaporizing technologies.

SFATA believes that the concerns and issues raised can be directly addressed by the creation and implementation of Good Manufacturing Practices and Standards which are drafted in joint effort and collaboration between members of the industry and government.

Kind regards, Cynthia CabreraExecutive Director, SFATA

When it comes to the TPD TVECA has no authority.

Yesterday, TVECA rocked the e-cig world when they wrote in a letter to MEPs, that they and their members support the current draft TPD in relation to electronic cigarettes and that although they had a few reservations, it was ultimately, “well done EU, we are fully behind you.”

This is the complete opposite to what the rest of the vaping community and industry are saying.

In their letter TVECA wrote that the “biggest share of the European electronic cigarettes industry” supports their position.  This is a bold statement, and if true, rather worrying.

However, if you look at the TVECA website this bold statement begins to unravel.  TVECA list only 16 individual member businesses, some very small, across the whole of the EU, and guess what?  11 of these 16 businesses are based in the Netherlands!  For the overwhelming majority of EU Member States TVECA has no member.

TVECA may argue that this is not a problem as their position and letter is also supported by a number of national trade associations from across the EU.  Again, if true this is very worrying.  One of the trade associations listed is CACE, the national trade association for the electronic cigarette industry in France.  Do CACE support the TVECA letter?  Not one bit of it.  It transpires that TVECA added CACE as a supporter without even showing them the letter; we can only assume that the same applies to all the other national trade associations cited in the TVECA letter.

Today CACE issued a statement that said:

“CACE disagrees with recent pronouncements TVECA, considering in particular Article 18 of the draft Directive tobacco as a preferred solution to the regulation of the market of electronic cigarettes in Europe. CACE here wants to assert its independence from the TVECA, whose orientations differ legitimate interests vapoteurs and French professional electronic cigarette.  In addition, the CACE is not a member of TVECA even if our association dialogue at European level, with all the actors involved in the draft Directive.”

CACE are an Industry organisation that on their website claims to represent 61 members (manufacturers and distributors), 58 commercial websites, nearly 241 specialty shops, 12,800 outlets representing more than 2,000 jobs and 1.5 million consumers.

TVECA is an American organization that allegedly fell out with another organization in the USA, namely SFATA, and so decamped to Europe.  Further inspection of their members sites show that the majority of their members are either flavour houses, or they sell nothing bigger than a basic eGo, (much like the tobacco companies that have joined the e-cig market), so the TPD is pretty much fine for them.  Having it amended to deal with the legitimate concerns of the majority of this industry and consumers would only increase their competition.  Far better to support a poor piece of legislation that will negatively impact their commercial rivals.

In the last week scientists and vapers from across the EU have made it clear that they cannot support the TPD in its current form.  We also understand that a letter signed by individual electronic cigarette companies stating their opposition to the TPD will be published this week.

In sending this letter TVECA have made a power grab for their own benefit, not the benefit of the majority of vapers who they clearly hold in contempt.  It is clear that TVECA want to be the only guys round the table negotiating the implementation of the TPD.

TVECA really do not speak on behalf of the “biggest share” of the electronic cigarette industry in Europe, they certainly do not speak for the public health community or the millions of vapers and their families.  MEPs have now got to decide whose side they will be on.

We hope that MEPs will see through TVECA and continue to stand up for public health and the rights of upwards of 12 million vapers throughout the EU.