We call upon the ENVI Committee to maintain its integrity and authority and vote against the tabled Trilogue changes.

On Wednesday, in accordance with the European Parliament’s Rule 70.5, the single vote on the revised Tobacco Products Directive (TPD) will take place in the Parliament’s Environment, Public Health, and Food Safety (ENVI) committee.

This will be the first time MEPs have had an opportunity to express a formal opinion on the TPD since the historic vote on the 8th of October last year.

As Martin Callanan MEP so clearly set out on these pages recently, a simple majority of ENVI committee members is needed for the committee’s consent on the negotiated text.

If the report is adopted in the ENVI committee with less than one-tenth of members voting against, (7 MEPs), the TPD will go to vote in plenary under Rule 138.

This will mean that the TPD will be subject to a single vote.

However, this could change if, before the drawing up of the final draft agenda, political groups or individual MEPs who together constitute one-tenth of all MEPs, (76 in total), request in writing that the TPD be open to amendment, in which case the Parliament’s President shall set a deadline for the tabling of amendments.

As vapers and scientists made clear last week, and as manufacturers will make clear this week, the TPD in its current incarnation is deeply flawed.  Clive Bates has drawn our attention to just one of these flaws on his excellent blog, and this is just one example drawn from a very long list.  We have arrived at this situation primarily because the current version of the TPD, and in particular Article 18, was drafted on the hoof, behind closed doors, and without any consultation with those who will be impacted by this directive.

Like many others, Save E-cigs has come to the conclusion that if Article 18 cannot be significantly amended, then it should be removed from the TPD.  Not all MEPs will wish to amend the TPD; some who previously campaigned on our behalf now believe that they have done all they can, and those who have always been against us are unlikely to support us now.  That said, a number of MEPs do want to at least try to have Article 18 amended.  Like us they see it as unworkable.  They recognise that it could lead to a ban on refillables, and that with a ban on certain currently available nicotine strengths, they worry that e-cigarettes may cease to be as effective and therefore will be seen as a less attractive alternative to smoking tobacco cigarettes.

Those MEPs who seek reform are supported by industry, the independent scientific/public health community, and most importantly, upwards of 12 million vapers from every corner of the European Union.

If any credibility is to be salvaged from this whole process, it is vital that these views are allowed to be heard in the European Parliament, even if ultimately they are voted down.  We, the ones who will have to live with the consequences of Article 18 should be given our opportunity to have our say and to have our arguments articulated by our democratically elected supporters in the European Parliament.

MEPs on the ENVI committee therefore have a wider obligation not only in ensuring they do not deny or make it harder for their colleagues to table amendments to the TPD if they so wish, but more importantly a duty to a very fundamental matter.  In October a majority of their MEP colleagues from across the political spectrum voted in favour of amendment 170.  It is therefore  their basic duty as members on the ENVI committee  to ensure that the wishes of the majority are reflected in their vote.  The TPD amendment that is in front of the ENVI Committee is significantly different  from amendment 170, and therefore no matter what individual members may feel personally or politically, the ENVI Committee can only, if it is to maintain its integrity and authority vote against the tabled Trilogue changes.

The easiest way for this to happen is for all members of the ENVI committee to vote unanimously to reject the TPD.  In laying aside their personal views on the TPD, ENVI members will make it easier for amendments to be tabled ahead of the final vote in plenary in March and will therefore be doing their colleagues and vapers across the EU a great service.

We urge all readers to contact members of the ENVI committee ahead of Wednesday’s vote asking them to vote reject the TPD.

You can find a full list ENVI committee members and their contact details here.

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Open letter, sent to the EU, signed by 15 Scientists, outlining why the TPD is scientifically flawed

This is an open letter, sent to the EU, signed by 15 Scientists, outlining why the TPD is scientifically flawed. The original letter is on website: http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/149-tpd-errors
Details
Created on Friday, 17 January 2014 11:47

 

Scientific Errors in the Tobacco Products Directive

A letter sent by scientists to the European Union

 

The scientific community is dedicated to support the need for appropriate interpretation of research on e-cigarettes and continues its efforts to provide proper and reliable information concerning e-cigarette regulation. Key scientists in the field of tobacco and e-cigarettes have sent today a letter to Health Commissioner Mr Tonio Borg and MEPs concerning the issue of e-cigarette regulation,explaining in detail and with references to medical studies the problems of the currently proposed regulation.

This is the letter sent to the EU.

 

Scientific Errors in the Tobacco Products Directive
January 16, 2014

Madam, Sir,

We are among the key scientists in the field of tobacco and e-cigarettes whose research is cited by the EU Commission and other public bodies interested in tobacco control. We understand that the Commission and MEPs want to ensure that safe e-cigarettes are easily available for smokers who wish to switch from smoking tobacco. With e-cigarettes proving popular among smokers, there is an ethical and intellectual imperative to build policy on robust science. The stakes are high, as smoking kills 700’000 citizens in the EU each year. Several of the recitals and provisions of Article 18 of the Tobacco Products Directive (TPD) which concerns e-cigarettes lack or misrepresent the scientific understanding of the relevant issues. This letter is to help you understand research findings relevant to the current TPD text.

1. TPD’s Comparison of Nicotine Delivery From Tobacco and Electronic Cigarettes

TPD Text: Recital c) for Article 18 states: “Nicotine containing liquid should only be allowed under this Directive where the nicotine concentration does not exceed 20 mg/ml. This level of concentration is similar to the dose of nicotine derived from a standard cigarette during the same duration of smoking.”

The science: The Commission quotes (1) Dr. Farsalinos’ papers (2,3) to justify the claim that 20mg/ml of nicotine matches the average cigarette delivery. Dr. Farsalinos has written to the Commission stating that they have misinterpreted his findings. His research instead shows that 20 mg/ml e-liquid provides less than one-third of the nicotine delivered by one tobacco cigarette (4,5). 50mg/ml is needed to roughly match a tobacco cigarette. All other existing studies confirm this (6-9). Some 20 to 30% of electronic cigarette users use liquids above 20mg (8,10). Higher nicotine content liquids are typically used by the most dependent smokers, who have the highest risk of smoking-related damage, and who benefit most from switching to electronic cigarettes. Most such heavy smokers need more than 20mg/ml to switch from smoking to vaping.

2. TPD’s Assumption On Nicotine Toxicity

TPD Text: Recital f) for Article 18 states: “Given that nicotine is a toxic substance…” and the Commission asserts that “The acute lethal dose of nicotine in an adult human is estimated to be about 60 mg” (11)

The science: One justification for limiting nicotine levels in electronic cigarette liquid to 20mg/ml rests on the claim that higher levels would be dangerously toxic. This is not the case. People have ingested doses 60 times higher, which only led to nausea and vomiting and no other adverse effects (12). The Commission’s contention that 60mg of nicotine is lethal has been traced to dubious self-experiments recorded in a pharmacology textbook of 1856 and not confirmed since then (13). Poisoning from tobacco, nicotine replacement medications or e-cigarette liquid is extremely rare. There is also no risk of overdosing through inhalation. As with conventional cigarettes, excessive doses cause nausea, so inhalation is stopped long before any overdosing or health damage is possible (for review of evidence, see 14). Childproof caps are sufficient to protect young children from swallowing e-liquids.

3. TPD’s Requirement For Consistent Nicotine Delivery

TPD Text: Article 18.3 says Member States shall ensure that:… (f) electronic cigarettes deliver the nicotine doses consistently”

The science: The medicinal concept of “consistent delivery” is inappropriate for a consumer product used freely. Users of cigarettes, oral tobacco and e-cigarettes spontaneously determine their nicotine intake according to individual and momentary needs. Individual users of the same electronic cigarette differ in their nicotine intake 20-fold (4,5,15). Quality control of individual brands is needed to ensure consistency of nicotine content but ensuring consistent delivery makes little sense. No such demands have been placed on tobacco cigarettes or oral tobacco.

4. TPD Requirement On Electronic Cigarette Manufacturers To Provide Data On Nicotine Absorption From Each Product

TPD Text: Article 18.2 Requires manufacturers to notify 6 months before a product or substantial modification goes to market data including: “information on nicotine dosing and uptake “

The science: Bearing in mind the above comments on nicotine delivery, such data would be of no benefit to consumers, but would incur large unnecessary costs. No such data are required from cigarette or tobacco manufacturers, and this, along with other regulatory proposals, would create a market advantage for the much more dangerous tobacco cigarettes.

5. TPD Requirement To Limit Electronic Cigarette Refill Containers To 10ml And Tanks To 2ml

TPD Text Article 18.3 a): “nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, disposable electronic cigarettes or in single use cartridges. The cartridges or tanks shall not exceed a volume of 2 ml”

The science: This proposal seems motivated by the concern about e-liquid toxicity, which is misinformed (see above). Electronic cigarettes have an excellent safety record so far (16). Worldwide, only one electronic cigarette fatality has been reported caused by a small child drinking electronic cigarette liquid from an open container (17). The Commission’s proposal for smaller containers would generate more handling of refill bottles, so a higher choking risk for small children and higher cost to users. The alternative approach used with much more toxic household chemicals such as bleach is for the risk to be mitigated by common sense, warning labels and child-proof containers.

6. TPD Assumption That Electronic Cigarettes Are A Gateway To Smoking

TPD Text Recital h) of Article 18 states: “Electronic cigarettes can develop into a gateway to nicotine addiction and ultimatelytraditional tobacco consumption, as they mimic and normalize the action of smoking. For this reason, it is appropriate to adopt a restrictive approach to advertising.”

The science The gateway effect is given as one of the reasons for a restrictive approach. Existing data however do not suggest that electronic cigarettes are having any such effects. Daily use of electronic cigarette in never-smokers was assessed in two studies, which found no such use (18, 19). In the US, 1-2% of children experimented with electronic cigarettes, with none shown to have become regular users (20). In contrast, 54% of 15-16 years old European adolescents have tried at least once smoking cigarettes, and 88% of adult smokers who smoke daily report that they started smoking by the age of 18 years (21, 22). The evidence is instead that the gateway effect is out of tobacco use, as at least some smokers of all ages reduce or end smoking when moving over to electronic cigarette. However, use in adolescent non-smokers should be closely monitored in the future.

In conclusion, electronic cigarettes have a very good safety profile and are likely to provide a gateway away from rather than into smoking. Users should be allowed to identify a product and dosage that suit them rather than have regulators decide what they must use. Evidence-based and proportionate regulation should be implemented, and all stakeholders should be involved in the regulatory process. If wisely regulated, electronic cigarettes have the potential to obsolete cigarettes and to save millions of lives worldwide. Excessive regulation, on the contrary, will contribute to maintain the existing levels of smoking-related disease, death and health care costs.

References

1) European Commission (2013) Fact sheet on E-Cigarettes http://ec.europa.eu/health/tobacco/docs/fs_ecigarettes_en.pdf

2) Farsalinos et al. Evaluation of Electronic Cigarette Use (Vaping) Topography and Estimation of Liquid Consumption. Int J Environ Res Public Health. 2013;10: 2500-14.

3) Farsalinos et al. Evaluating nicotine levels selection and patterns of electronic cigarette use in a group of ‘Vapers’ who had achieved complete substitution of smoking. Substance Abuse: Research and Treatment. 2013; 7:139-146.

4) Farsalinos K. et al. Nicotine absorption from electronic cigarette use: comparison between first and new generation devices. Presented to the FDA, December 19, 2013 (submitted for publication).

5) Farsalinos K. et al. Nicotine absorption from electronic cigarette use: comparison between experienced and naive users. Presented to the FDA, December 19, 2013.

6) Vansickel AR, Eissenberg T. Electronic Cigarettes: Effective Nicotine Delivery After Acute Administration. Nicotine & Tobacco Research 2012.

7) Hajek P, Goniewicz M, Phillips A, Myers-Smith K, West O, McRobbie H. Nicotine intake from electronic cigarettes and effect of practice: Report to the MHRA. London: Wolfson Institute of Preventive Medicine, Queen Mary University of London, 2013.

8) DawkinsL, CorcoranO. Acute electronic cigarette use: nicotine delivery and subjective effects in regular users. Psychopharmacology (Berl). 2014 Jan;231(2):401-7.

9) Nides MA, Leischow SJ, Bhatter M, Simmons M. Nicotine Blood Levels and Short-term Smoking Reduction with an Electronic Nicotine Delivery System. American Journal of Health Behavior 2014; 38(2): 265-74.

10) Etter, J. F. & Bullen, C. (2011) Electronic cigarette: users profile, utilization, sa tisfaction and perceived efficacy, Addiction, 106, 2017-28.

11) SCENIHR Scientific Committee, 2010 p 29 http://ec.europa.eu/health/scientific_committees/opinions_layman/tobacco/documents/addictiveness_and_attractiveness_of_tobacco_additives.pdf

12) Christensen LB, van’t Veen T, Bang J. Three cases of attempted suicide by ingestion of nicotine liquid used in e-cigarettes, Clinical Toxicology. 2013; 51: 290.Clinical Toxicology vol. 51 no. 4 2013

13) Mayer B. How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century. Arch Toxicol. 2014 Jan;88(1):5-7.

14) See the literature review on slides 10 and 11 at http://www.e-cigarette-forum.com/infozone/Dr-Jacques-Le-Houezec

15) Etter JF. Levels of saliva cotinine in electronic cigarette users, Addiction. 2014 Jan 8.

16) Polosa R, Rodu B, Caponnetto P, Maglia M, Raciti C. A fresh look at tobacco harm reduction: the case for the electronic cigarette. Harm Reduct J. 2013 Oct 4;10(1):19.

17) Winer S (2013). Police investigating toddler’s death from nicotine overdose, Times of Israel, May 29.

18) Douptcheva N, Gmel G, Studer J, Deline S, Etter JF. Use of electronic cigarettes among young Swiss men. J Epidemiol Community Health. 2013; 67: 1075-1076.

19) Action On Smoking And Health (2013). ASH fact sheet on the use of e-cigarettes in Great Britain (London, ASH).http://www.ash.org.uk/information/facts-and-stats/ash-briefings

20) CDC (2013). Notes from the field: electronic cigarette use among middle and high school students – United States, 2011-2012,MMWR Morb Mortal Wkly Rep, 62, 729-30. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6235a6.htm

21) The 2011 ESPAD Report. Substance Use Among Students in 36 European Countries.
http://www.espad.org/Uploads/ESPAD_reports/2011/The_2011_ESPAD_Report_FULL_2012_10_29.pdf

22) U.S. Department of Health and Human Services. Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2012. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm

Signatories

Professor Jean-François Etter, PhD,

Associate Professor, Privat docent, Institut de santé globale, Faculté de médecine, Université de Genève, Switzerland.

Dr. Konstantinos Farsalinos, MD

Researcher, Onassis Cardiac Surgery Center, Athens, Greece
Researcher, University Hospital Gathuisberg, Leuven, Belgium.

Professor Peter Hajek, PhD

Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry Queen Mary University of London, London, UK.

Dr. Jacques Le Houezec, PhD

Consultant in Public Health, Tobacco dependence, Rennes, France
& Honorary Lecturer, UK Centre for Tobacco Control Studies, University of Nottingham, UK.

Dr. Hayden McRobbie, MB ChB PhD

Reader in Public Health Interventions, Wolfson Institute of Preventive Medicine, Queen Mary University of London, UK.

Professor Chris Bullen, MBChB, PhD

Director, The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.

Professor Lynn T. Kozlowski, PhD

Dean, School of Public Health and Health Professions, Professor of Community Health and Health Behavior, University at Buffalo, State University of New York, USA.

Dr. Mitchell Nides, PhD

President, Los Angeles Clinical Trials, Director, Picture Quitting, the Entertainment Industry’s, Quit Smoking Program, Burbank, CA 91505, USA.

Professor Dimitris Kouretas, MD

Professor and Deputy Rector University of Thessaly, Greece.

Professor Riccardo Polosa, MD, PhD

Director of the Institute for Internal Medicine and Clinical Immunology, University of Catania, Italy.

Dr. Karl Fagerström, PhD

President, Fagerström Consulting AB, Vaxholm, Sweden.

Professor Martin Jarvis, Dsc

Emeritus Professsor of Health  Psychology, Department of Epidemiology & Public Health, University College London, UK.

Dr. Lynne E. Dawkins, PhD

Senior Lecturer in Psychology, School of Psychology, University of East London,  Stratford, London, UK.

Dr. Pasquale Caponnetto, Assistant Professor, Researcher

Centro per la Prevenzione e Cura del Tabagismo, Azienda Ospedaliero-Universitaria “Policlinico-V. Emanuele”, Università di Catania, Catania, Italy.

Professor Jonathan Foulds PhD

Professor of Public Health Sciences & Psychiatry, Penn State University, College of Medicine, Cancer Institute, Cancer Control Program, Hershey, PA 17033-0850, USA.

 

A Deal On E-cigarettes – What next?

Guest post by Rebecca Taylor, Lib Dem MEP.   Rebecca Taylor

 

The final trialogue negotiations on e-cigarettes are now several weeks behind us.

Although the deal reached was far from perfect, we must recognise that remarkable progress has been made.

Just a few months ago it looked like e-cigarettes were well and truly doomed. The original Commission proposal would have effectively imposed pharmaceutical regulation across the whole of the EU on all but the least effective devices, and enjoyed majority support of Parliament’s public health committee (ENVI) and unanimous backing from all 28 national governments.

But a decisive victory was won for e-cig users in October when MEPs in Parliament adopted the Liberal-drafted amendment, which steered e-cigs away from over-burdensome medicinal licensing towards a more appropriate consumer product regulatory framework.

Several national governments then began to privately doubt whether the pharmaceutical regime was the best route for e-cigs, although none said so publicly. This did however lay the groundwork for the deal agreed in December, which whatever you think of it, represents a significant climb down from a position unanimously held by 28 national governments.

The package must now be signed off for a final time by a vote of the European Parliament, which is likely to take place in March.

There have been calls to table an amendment to article 18 ahead of the Parliament’s final vote. This is an infrequently used procedure which, if an amendment were to be adopted, would effectively break the deal reached by the Parliament and national governments on the entire Directive. If the amendment adopted by parliament was not accepted by national governments, the entire Tobacco Directive would then go into second reading.

I fear this could jeopardise the important work that has been done on the rest of the Directive upon which parliament and national governments were able to agree without too many problems. Although this would allow article 18 to be re-visited, it would also give tobacco companies another opportunity to chip away at the tobacco control measures.

In addition, it would provide those who have opposed sensible regulation of e-cigarettes with another opportunity to lump e-cigarette advocates together with the tobacco lobby, which in the worst case scenario could see an even more inappropriate article 18 emerge.

It would be untrue to say that I am happy with Article 18 as agreed in trialogues, but for the reasons stated above, I would not advocate that the Parliament reject the TPD in its entirety.

I do believe there is still a battle left to fight, and so I am currently looking carefully in to a number of options and discussing them with colleagues.

There are essentially three options open:

1)    Tabling an amendment which removes article 18 from the Tobacco Products Directive altogether and requires the Commission to come up with a new proposal

This should allow the development of a regulatory framework specifically designed for e-cigs, which could then go through the appropriate consultation procedures. However, if adopted, such an amendment would break the trialogue deal, but it doesn’t have to if national governments can accept moving forward with the rest of the TPD intact.

Potential advantages: the chance to develop a customised regulatory framework for e-cigs that would be workable for manufacturers and vapers and help encourage more switching. With more public health organisations and leading experts moving away from the medicines route, we can be reasonably optimistic that a better outcome can be achieved. This would also not touch the tobacco control measures as long as national governments could agree to move forward with the rest of the TPD.

Potential risks: e-cig opponents get better organised (they thought medicines regulation was in the bag until shortly before the October plenary vote and the hysteria of some anti e-cig messages helped secure amendment 170), and re-opening article 18 results in a worse outcome than the current trialogue deal. This is also linked to uncertainty about the shape of the post June 2014 Commission (Commissioners are appointed by national governments) and Parliament (more Eurosceptics who do not engage with legislation meaningfully?). This is a worst case scenario, which I think is rather unlikely, but not impossible.

2)    Tabling amendment which alters the text of article 18 as agreed in trialogues

Potential advantages: we get the right framework for e-cigs sooner rather than later.

Potential risks: As well as being very difficult to convince fellow MEPs to back this option, I am almost certain it would not be accepted by national governments, so it would break the trialogue deal and push the TPD into second reading. This could easily result in e-cigs advocates being held responsible for giving tobacco companies another crack at the whip.

Also worth noting: One of the arguments for removing article 18 and re-doing it, is on procedural grounds, namely that article 18 was inserted into the draft directive at the last minute and not subject to the same consultation as the rest of the proposal and that the final text that emerged in trialogue negotiations has had no input from stakeholders. This is in some ways a stronger argument than simply opposing the content of the trialogue deal on article 18, as the same could be argued about many other proposals, and it could be seen as merely sour grapes. If we were to push a new text that would, due to the nature of the procedures involved, be put forward without any proper consultation or significant time for MEPs to examine it, then we would be doing what we criticised others for doing.

3)    We accept the trialogue deal and focus our energies on ensuring the regulatory framework agreed is implemented in the most flexible and workable way possible.

Whatever happens, this needs to be done as with most legislation “the devil is in the details”, so getting things implemented in a workable way is vital.

In the UK, I continue to try and win over more Lib Dem colleagues at Westminster to ensure greater pressure is placed on the UK government not to push regulation towards the MHRA route, as has been advocated by Conservative Health Secretary Jeremy Hunt and Health Minister Jane Ellison. Already, Liberal Democrat MPs such as Norman Lamb (social care minister), Dan Rogerson, John Pugh and Lorely Burt have been fighting the corner for e-cig users.

Potential advantages: we know what we are getting and our engagement cannot make it worse.

Potential risks: losing the opportunity to get something better.

I would repeat my previous call for concerned individuals to contact their local MP to raise this issue (regardless of which way things go), so that a greater number of MPs including Labour and Conservatives, can also be won over.

Until then, as always, I welcome comments from e-cig users, who can rest assured that I and my Liberal Democrat colleagues are still very much on their side.

 

Lets face the truth, decisions in the area of tobacco products are always and exclusively made for financial and not health reasons.

dr-riccardo-polosa-italie+

Guest post by Dr Riccardo Polosa.

I was positively surprised when Members of European Parliament voted  against the pharmaceutical regulation of e-cigs proposed by the European Commission, during the first reading of Tobacco Products Directive (TPD), on 8th October 2013. It seemed as if they finally figured out the risks of over-regulating a product designed to reduce the health damage caused by tobacco smoking. Or so I thought.

 

Hurriedly, behind closed doors, and with restricted consultation, the EU legislators managed to introduced substantial modifications in the revised TPD, producing a profoundly mutated document that takes a completely different approach for e-cigs. The newly approved document is riddled with many arbitrary and disproportionate measures. And it could have been much worse thanks to the determination of a handful of brave MEPs who have fought hard to limit the damage.

 

In essence, this new document makes e-cigs much less attractive for those tobacco smokers contemplating to switch to a much reduced risk product. In particular, introduces the arbitrary limit of 20 mg/ml on the max strength of nicotine allowed in e-liquids, advertising bans as stringent as those currently in place for conventional cigarettes, plus several (yet, poorly defined) lab testing, reporting and compliance requirements.

 

Unfortunately, no consideration was given to setting up useful agreed purity standards for e-liquids or operating standards for devices. A simple regulatory framework that ensures consumer protection and product quality and that may work for these products already exists.

For example, e-liquids may be marketed as dietary supplements or cosmetics, whereas marketing and safety of e-cigarettes’ electronics, batteries, and spare parts are already regulated by the existing directives about electronic products design.

 

The minor or implausible health concerns that have constituted the main obsessive focus of EU legislators in the e-cig debate may sound like stupid excuses, when in fact they are not stupid at all. To tell the truth, they are clever excuses. So clever that they succeeded in their purpose of dictating rules in line with the precautionary principle. Hence, the fact that the new document makes e-cigs much less appealing for new smokers is deliberate…

 

Lets face the truth, decisions in the area of tobacco products are always and exclusively made for financial and not health  reasons. After weeks and weeks of fierce debate with the EU “legislators” I came to the conclusion that this has very little to do with a medical issue or science, it is a political and financial one. I briefly addressed this point in the concluding paragraph of my opinion letter

in the Lancet:

http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70175-9/fu

lltext

 

Similar conclusion can be drawn from the current situation in Italy.

From 1st January 2014 e-cigs will be regulated as tobacco products. Measures will include: excise taxes, lengthy bureaucratic process to obtain marketing permission from the national tobacco authority, vaping bans in public places, and advertising bans. No scientific debate was allowed, no input from vapers and their families was taken into consideration, the political agenda being “destroy e-cigs as soon as possible”. These draconian measures are already driving the prosperous and active national e-cig industry outside Italian borders, thousands of vape shops are closing, and current vapers will either have to turn into black market to stay off tobacco smoking or return to their own tobacco brand. Italy is well known for its lengthy legislative processes. For the e-cigs this was completed in less than 6 months ! A word to the wise is enough….

 

Clearly, the rapidly expanding popularity of e-cigs represents a threat to the interests of many, including national governments – because of the fat revenues generated by tobacco excise taxes. Only if these obstacles can be overcome, a truly sensible and rational regulation of e-cigs will be agreed upon, and millions of lives saved.

 

 

Making sense of the proposed new e-cigarette regulations

Making sense of the proposed new e-cigarette regulations
Guest post by Clive Bates.

Half full or half empty?
Half full or half empty?
 
As the final negotiation over e-cigarettes in the tobacco products directive drew to a close. a nameless ‘senior diplomat involved in the negotiations’ was quoted in The Guardian. They were talking about e-cigarettes: It’s inhaled. It’s direct inhalation of nicotine into the lungs. That creates an addiction very fast… It encourages a switch to real cigarettes.” 
This is wrong in every respect – and not one scintilla of evidence justifies it, but plenty confounds it. So how come someone so ignorant is meddling in legislation to regulate products that are in fact amazingly positive alternatives to smoking? Why did the Guardian feel obliged to conceal the identity of this person?  So that a public official could remain unaccountable for their rogue opinions or propaganda statements?  People look at that sort of thing and rightly ask: “what do they know? And why are they in the room deciding on something important to me, when I’m shut out and no-one is listening to me and my experience?”.  I agree completely with this view – the e-cigarettes parts of the directive have been negotiated in secret, in insular meetings, where any old nonsense is treated as fact, and where evidence is brought in to support political decisions, not to inform policy.  Above all, they do not seem aware of the astonishing arrogance of agreeing something like this without consulting the millions of users and thousands of businesses affected or the dozens specialists who do the science and know the evidence?  For me, poor policy-making process is the reason why we end up with poor policy.  I’ve argued on my own blog that ‘embarrassingly poor policy-making‘ is the primary problem – poor legislation is the result of that. The right thing to do would have been to take out the e-cig proposals and do the job properly. But politicians and civil servants see themselves as heroic actors and don’t easily recognise the shortcomings of the processes in which they are playing a central role.
So what have they some up with?   
The e-cigs text, like the rest of the directive is a sprawling mess, with many arbitrary and disproportionate measures fiddling around with product design and commercial freedoms.  As a public health measure it is poor.  As a consumer protection measure it is poor.  As an EU internal market measure it is poor.  The main defence for the text as it stands is that it could have been much worse – and this is true.  We do owe thanks to MEPs like Chris Davies, Rebecca Taylor and Martin Callanan who have fought the good fight for vapers…  I only wish they’d succeeded in pulling it out and getting a new directive.
The main problem in general has been the obsessive focus on minor or implausible risks at the expense of the potential huge gains to smokers if the e-cigarettes can be made attractive enough to encourage switching.  Instead they have tried to make e-cigs deliberately unattractive, supposedly to protect non-smokers – but this is a serious public health miscalculation, given the minimal risks to the latter and huge benefits to the former. The public health establishment has done much to encourage that and has shown it has not learnt any lessons from its 21 year lethal error in supporting a ban on snus.
Compared to the darkest days of the worst proposals, the final text is not all bad and some of the most ridiculous ideas have been seen off in the negotiations.  In the end it has came down to frantic late night negotiation over rather weird things:
  • Maximum nicotine density for e-liquids now at 20mg/ml.  Completely counterproductive – limiting e-cig appeal to heavier smokers, preventing more compact energy efficient devices, and blocking future innovations.  And cuts through the ranges of the major manufacturers.  But significantly lower thresholds were under discussion at one point – the Germans wanted 5mg/ml!
  • Maximum nicotine quantity per single use cartridge – at one point an unfeasible 10mg – now specified as 2ml (therefore up to 40mg if the liquid is 20mg/ml) in a single use cartridge. There was no need to limit this quantity at all as safety concerns are addressed through packaging standards.
  • Maximum refillable container size of 10ml has been agreed.  Stupid and pointless, but not fatal as I think quite a common refill size.  We would normally control risks from hazardous liquids by packaging and labelling – not by reducing the size. Imagine if we took that approach to bleach or drain cleaner.
  • No EU ban on refillable (2nd and 3rd generation) devices.  This was in prospect but has been successfully thwarted – though with some strings. The Commission will have powers to ban them if three members states do and they can justify it on proportionality grounds – though this is more likely to apply to a specific dodgy product than the entire refillable category.
  • No EU flavour bans. Regulations are to be left to the members states. At one point they wanted to allow only flavours approved for use in NRT, which would have been absurdly limiting.  But now we will probably end up with lots of arbitrary rules based on the wrong assumption that adolescents want to use flavours that are childish.  I reckon if there was anthrax flavour it would be more popular with them than strawberry sherbet or. whatever…
  • Many forms of advertising, sponsorship, promotion, product placement – TV, radio, cross-border – are banned.  This is ridiculous and disproportionate – and will cause all sorts of damage (eg. to sponsored forums).  The products are much less dangerous than alcohol and could be regulated with a code – as the UK is planning to do.
  • Cross border distance sales – these can be banned by member states, but are not automatically banned.
  • Lots of testing, reporting and compliance requirements – but no pre-market authorisation regime, which would have created major political and administrative barriers
  • Age limits. Not included as these are a matter for member states.
  • Medicines regulation – they seem to want the flexibility to regulate e-cigs as medicines at national level.  Heads in the sand on this, given they keep losing in court. 
  • Timing.  Looks like intent is to bring in the measures 24 months after entry into force (likely May 2016) with possible additional 12 months for non-compliant products already on the market – this is one area that is unclear in the drafting.
  • A number a strange statements are made in the recitals to justify the measures,  for example about a gateway effect – something there is no evidence for at all.
Missing things
They don’t seem to have set up a proper basis for setting agreed purity standards or operating standards for devices.   That might have been useful. 
They don’t seem to have given any thought to unintended consequences – black or grey market, DIY, non-nicotine products, internet trade etc
 
An end to free speech?
Many people have picked out what sounds like a draconian curtailment of free speech in paragraph 5 of Article 18  “any form of public or private contribution to [media] with the aim or direct or indirect effect of promoting electronic cigarettes is prohibited“.  It isn’t actually – the key word is ‘contribution’, which means ‘paid for’ with the aim of promoting a product.  Brussels speak for advertising, sponsorship and promotion – as already used in the directives that ban tobacco advertising.
Legal challenges?
i mention the EU internal market above, because that is the legal base for this measure – it is supposed to support the free movement of goods around the EU, albeit with a high level of health protection.  But departures from free movement principle on health grounds do need to be based on evidence and be proportionate and non-discriminatory – and many of these are not.  It remains to be seen if anyone has both the intent and muscle to challenge any of it in court.
What happens next? 
It’s not law until both the full European Parliament and European Council (member states) agree the text.  The EP is likely to vote on it at its January or February plenaries (w/c 13 Jan, 4 Feb, or 24 Feb) but a date is not yet set. If EP agrees it goes back to the European Council for final rubber stamping – then becomes law. If the EP amends or votes it down, then it goes to a second reading or the Council can accept the EP amendment.  The UK government will also have to go into the Westminster parliament and defend its approach before it can sign up to the text at the European Council.
E-cig industry
Industry attention will turn to what many of the more vaguely expressed measures actually mean in practice….
– What will the definition of “consistent dosing” be? Will there be a standard deviation? What will this be and do current product lines respect it?
– How will manufacturers be asked to report nicotine uptake? Does this require a PK study? Are there other ways it can be done?
– How will the technical standards of the refill mechanism foreseen for bottles be drawn up?
– What kind of toxicity data will be required?
– What kind of emissions data will be required?
 
What can vapers do…? 
1. At every opportunity write to MPs, MEPs and ministers and keep making the case relentlessly. Watch forums for tactical advice on when and who to contact and on what theme.
2. Consider political strategy for the directive  – come out fighting or move with the punch…?
Come out fighting? Should we try to get this rejected at the European Parliament plenary? One approach would be a simple ‘delete’ amendment, replace with “The Commission shall consult and publish a review the risks, benefits and regulatory arrangements for e-cigarettes within 12 months and bring forward legislative proposals as appropriate”.  The value of this depends on the prospect of securing a majority in the European Parliament – that is still hard to gauge at present.  It would be necessary to show some fairly blatant unintended consequences or harms to convince MEPs to go out on a limb for this.
Move with the punch? Focus on making the implementation work and pressing for flexibility where there are obviously errors. Working out what it means in practice and focussing on implementing regulations.   We would need some key flash points to tackle with this,
3. Recognise that product regulation is one battle of many.  There is still huge work to be done on many fronts: vaping in public places: the attitude of NHS, Directors of Public Health and local authorities; keeping the MHRA in its box; and generally winning a propaganda war in which supposedly respectable organisations are playing dirty and elements of the media are taking every opportunity to have a go.
Clive Bates

Twitter: Clive_Bates

Why Article 18 now needs to be removed from the TPD. An open letter to MEPs

Dear Member of the European Parliament,

 

E-cigarettes and Trilogue

 

On the 8th of October e-cigarette users (vapers) welcomed the vote in the European Parliament, believing it to have been a sensible compromise.  MEPs had listened to the genuine concerns of vapers throughout the EU and a cross party majority supported amendment 170.

 

Now the Tobacco Products Directive (TPD) is in trilogue and vapers are being kept in the dark.  Vapers do not know what is being discussed and what regulatory proposals are gaining support.  Many vapers feel frustrated and isolated.  They hear rumours and read about leaked proposals, yet they feel totally impotent.  They cannot influence proceedings even when they fear the wrong decisions may be being taken.

 

From the leaked documents we have seen, it is clear that the new proposals being put forward by the Council and Commission are more than simple amendments to aid the trilogue process; they amount to entirely new proposals for the regulation of e-cigarettes.  As the EU protocol on the Application of the Principles of Subsidiarity and Proportionality makes clear, new proposals like these need to be forwarded to national parliaments for comment, with eight weeks for the national parliament to respond.  The new proposals that we are aware of are also about as far removed from amendment 170 as is possible.

 

In a desire to conclude the TPD before Christmas, due process, legitimate concerns, and legal opinions are being ignored by many of those involved in the trilogue process.  This is not how good legislation is made.

 

If trilogue and/or Parliament cannot deliver a regulatory regime for e-cigarettes that protects flavours and refillable tanks, and allows for the continued use of effective strengths of nicotine, then reluctantly we would have to come to the conclusion that Article 18 should be removed from the TPD and that the Commission should instead bring forward a new legislative proposal for the regulation of e-cigarettes.  We believe that this will allow the TPD to be drawn to a rapid and satisfactory conclusion before Christmas.

 

In the interim the TPD should be used to send a strong signal to Member States that they should more forcefully apply and enforce existing regulations relating to e-cigarettes, as we believe that when correctly adhered to, they are robust and proportionate.

 

As a campaign representing vapers and their families, we endorse the Electronic Cigarette Industry Trade Association Industry of Excellence Audit Programme and commend it to the e-cigarette industry and to policy makers.  We would also like to see vendors doing more to keep their customers informed and up to date with proposed changes to the regulation surrounding e-cigarettes.

 

The Commission should use this interim period to consult with all those who have a genuine interest in the sale, manufacture, and, most importantly, use of e-cigarettes.  They will then be in a good position to bring forward new legislative proposals (informed by the European Parliament’s position) with proper evidence based justification, impact assessment, consultation, and scrutiny.

 

Finally, may we take this opportunity to wish you and your family a Merry Christmas and a Happy New Year.

 

Yours sincerely

 

Save E-cigs

www.saveecigs.com

 

 

 

 

 

Day 70 in the House of Commons and still no debate. However now the MPs have noticed!

 On the 4th of September the European Scrutiny Committee formally recommended that the draft TPD be debated in full by European Committee C.  Last week we raised the question of why this debate has not taken place yet.  Well it is now 70 days since the initial recommendation and still no debate! However, it does seem that we are being listened too.  Today we received the following statement from the European Scrutiny Committee Chairman:

 “In our Report of 4 September, we recommended a debate on the Directive in European Committee.  We asked that, prior to the debate, the Minister write to the Committee with the key changes sought by the European Parliament and the Government’s views on them. Today’s Report scrutinises the Minister’s response, notes that trilogue negotiations may be concluded by the end of the year and presses the Government to hold the debate as soon as possible.

 We hear that a number of MPs will also be asking questions in Parliament about this lack of formal debate.  As soon as we hear more we will let you all know.