TPD Art 20 Response from Clare Moody MEP and my reply.

Evening all,

firstly my apologies for being AWOL. Starting the new job has taken a bit of getting used to, especially the two 12 hour night shifts each week. And the help I've been giving Bristol Stop Smoking Service. Sleepy IT is tricky ;-)

A while back I wrote to my MEPs, MP, members of the House of Lords. I had some great and quite rapid replies, especially from +Richard Graham and Baroness Hayter.

So I was surprised ( and eventually disappointed) to get a reply today from +Clare Moody MEP . It was pretty typical "cut and paste" fare which did little to explain or justify. Hopefully it and my reply reinforce why the Article 20 Legal Challenge is so important and why Sarah Knapton (Telegraph Science Correspondent) shouldn't really be surprised that we're a little grumpy :-)


18 September 2015                                                              Our Ref: CM/KW/SUMM01007/01150934
Dear John

Thank you for your email and I apologise for my delayed response. I am pleased to read that your health has improved since cutting down smoking with the aid of e-cigarettes.

I have discussed this issue with my colleagues who sit on the relevant European Parliament committee. The new EU directive on tobacco and related products will regulate e-cigarettes across the European Union for the first time. This regulation is both flexible and robust, and will ensure that consumers can be assured of the safety and quality of these products.

E-cigarette manufacturers have the option of having their products treated like tobacco products, meaning they can be sold freely as long as they meet certain safeguards. Alternatively, e-cigarette manufacturers who wish to do so can still apply for a licence (medicines route) and would be able to advertise, have their products available in pharmacies and on prescription by doctors, and sell stronger strength products. Two major e-cigarette companies in the UK have announced that they will seek a license in this way.

Throughout the process of deciding this new law, my colleagues were aware of the potential benefits of e-cigarettes for regular smokers who want to cut down or quit smoking. But we were also mindful that there are safety issues with e-cigarettes which need addressing.  We therefore steered a path avoiding over-regulation, keeping e-cigarettes on the market but within a reasonable regulatory framework which responsible manufacturers can accept. The final outcome reflects a compromise between the European Parliament and the Member States and ensures that safety and quality controls for consumers are treated as a high priority. I believe this is an outcome that the vast majority of European citizens can support.

It is worth noting that most member states wanted e-cigarettes to require a medicines license in all circumstances. The UK was arguing for stricter legislation at the Council of Ministers, so if the EU hadn't legislated on e-cigarettes it would have been up to the individual member states and many, including the UK, would probably have gone further than the Directive.However, it is still open for member states to go further than the Directive in certain areas so you may want to write to your MP to ask about the way that the UK plans to implement this legislation.In summary and I hope to reassure you, there is no ban on e-cigarettes contained in the EU legislation. Further, to clarify, the TPD criteria is a maximum concentration for nicotine liquid of 20mg/ml (this is comparable to the dose delivered by a standard cigarette and much higher than the 2mg/ml that the member states wanted) and the maximum size of a cartridge or tank would be 2ml.Finally, Labour MEPs were not motivated by tobacco/pharmaceutical industry lobbying but by concern for public health. We recognise the health benefit of products that can help people quit smoking, but consumers rightly assume that if a product is freely available on the market, then it is safe; we wanted the regulation of e-cigarettes to ensure this is true. We also wanted to ensure that these products were not being used as a gateway to nicotine addiction and smoking by young people.I hope that you have found this information helpful.

With best wishes

Clare Moody
Labour MEP for the South West and Gibraltar
www.claremoodymep.comTwitter @ClareMoodyMEP Facebook: ClareMoodyMEP

Thank you for your reply. 
I believe you misunderstood my previous statement. I have not "cut down" on smoking, I actually stopped smoking 5 years ago. Vaping (I dislike the term e-cigarettes as they are nothing like cigarettes) involves no combustion and none of the carcinogens or other "harmfuls" present in tobacco smoke. Nicotine is not the issue. 
I wholeheartedly disagree with the points you present. 
The TPD Article 20 amendments (hereafter referred to as TPD) are not, and were never intended to be, flexible or robust. They were created to appease the Tobacco industry, anti-nicotine zealots and others. Indeed Martin Seychell and others are on record as having said that they were intended to create a level playing field between NRT and ecigarettes. The amendments also came about during a period when, as we now know, the EU and Tobacco companies were involved in secret discussions around the TTIP.
The TPD does not ensure product safety. That responsibility falls to existing legislation around consumer products, electrical devices and chemicals/labelling. Nothing within the TPD deals with any specific issues of safety other than setting arbitrary limits on Nicotine levels. The only other concession I would make is the ban on sale to U18s, something which every responsible seller I know of already adheres to and sadly will do nothing to prevent irresponsible sellers (as with tobacco). The TPD is intended to effectively ban the sale of the most efficacious vaping products.
Vaping users and the manufacturers themselves have been instrumental in crafting the proposed BSi standards for vaping product safety. Not the EU, not the TPD.
Your colleagues were not acting as persons aware of the benefits would, in fact the TPD group as a whole discounted large amounts of evidence (scientific, social and medical) that indicated the level of regulation was unwarranted and unhelpful. Electronic cigarette manufacturers (and users) are artificially pushed into "Tobacco" and "Medicine" groupings when the product is neither. And in all cases the costs of testing and compliance are prohibitively high for all but the most well funded makers, principally Tobacco (and potentially Pharmaceutical) companies. I'm not aware of any electronic cigarette manufacturers that are intending to go down the medicinal route, can you tell us who they are? And as for the concepts of consultation and citizen acceptance, they are in this case laughable. There was no effective consultation.
What "safety issues" were being considered specifically? I'm not aware of any reasonable ones, only those raised in thoroughly debunked "research".
The regulatory framework is not reasonable, it calls for things such as the "spill proof, leak free filling mechanism" which doesn't exist. It bans discussions around vaping, especially across borders. It places artificial limits on tank sizes etc. And it introduces a cumbersome and unwieldy "pre-registration" with bodies that do not understand the products or users.
Regarding medicinal licensing, it had already become quite apparent in the UK and other member states that this was not going to be an effective or reasonable route, and was (independently of the TPD discussions) already being dropped.
The concept that the population assume items legally on sale to be safe is utterly disingenuous. There are obvious cases where cleaning chemicals, tools, plants, alcohol, medicines etc are on sale but not regarded as safe. Please do myself and the population at large the courtesy of not treating us as mindless.
Finally "gateway to addiction" and child usage. Firstly, nicotine separate from tobacco is less addictive (some studies place it as no more addictive than caffeine". And in both the adult and child cases there has repeatedly been shown to be no gateway effect.
I would strongly suggest that you and your colleagues take the time to thoroughly read the Public Health England report and consider why the Public Health bodies who have given their backing to it have done so. Even the Faculty of Public Health have turned against two of their senior members (who were vehemently opposed to vaping for purely ideological reasons) and given their support to the PHE position. 
I would strongly urge you and your colleagues to consider carefully the path that we've been forced down and why this has been allowed to happen. You are my MEP, yet you are acting against the best interests of myself, my family and others. If this is allowed to proceed we will not forget or forgive. 
At the end of September and beginning of October this year the TPD amendments face strong legal challenges from several EU member nations. I hope it is stricken down for the malicious, ill conceived and corrupt contrivance it is. 
Please excuse my obvious lack of appreciation. Rhetoric, party line and ideology are not information in my book, I study science and facts, not politics and commerce. 
John Summers

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