With all due respect Mr Drakeford….

Dear Mr Drakeford,

We would like to thank you for taking the time to attend and listen to the debate on Welsh Government proposals for a ban on the use of e-cigarettes in enclosed public spaces, substantially enclosed public places, and places of work in Wales. In your response to the debate you raised a number of issues that cause us concern.

You stated e-cigarettes were renormalising smoking and undermining the ban on smoking in public places.

On both points you were unable to provide any evidence that e-cigarettes were either renormalising smoking or undermining the ban on smoking in public places. However, Professor Robert West, Professor of health psychology and director of tobacco studies at University College London’s department of epidemiology and public health, following his latest research concluded:“Despite claims that electronic cigarettes risk re-normalising smoking, we found no evidence to support this.”[1]

You stated e-cigarettes act as a gateway to smoking tobacco cigarettes and that this was a particular problem for children who are using e-cigarettes in growing numbers. You stated that many of these children were not currently or previous smokers of tobacco cigarettes and were attracted by flavoured e-liquid.

To justify this claim you cited a study produced by John Moores University entitled ‘Young People’s Perceptions and Experiences of Electronic Cigarettes’. You gave the impression that this report stated that as a direct result of targeted advertising by e-cigarette manufacturers, large numbers of children, who had not previously smoked tobacco cigarettes, were now using e-cigarettes and then going on to smoke tobacco cigarettes. What the report actually states is that ‘Overall seven out of eight young people had never accessed e-cigarettes’. The report goes on to say, ‘Despite widespread advertising of e-cigarette brands in print, visual and social media, the majority of participants reported that they had not seen any advertising for e-cigarettes and showed a lack of awareness of advertising and marketing strategies and approaches’.

What we do know from recent research produced by ASH is that e-cigarettes are not a gateway to smoking. Deborah Arnott, Chief Executive of ASH, said: “There is no evidence from our research that e-cigarettes are acting as a gateway into smoking.”[2] Furthermore, this same survey demonstrated that children are not using e-cigarettes. The survey found that regular use of e-cigarettes amongst children and young people is rare and is confined almost entirely to those who currently or have previously smoked[3]. Research by ASH[4] found that 96 per cent of 14 year olds had never used an e-cigarette, 90 per cent of 15 year olds had never used an e-cigarette, 90 per cent of 16 year olds had never used an e-cigarette, and 91 per cent of 17 year olds had never used an e-cigarette.

Research undertaken by Queen Mary University in London[5] found that a child trying a tobacco cigarette for the first time is 50 per cent likely to become a regular smoker. The same research found no evidence that a child trying an e-cigarette for the first time goes on to become a regular vaper.

Evidence produced by a variety of organisations including ASH and the American Cancer Society (ACS) clearly shows that flavours do not entice non-smokers to use e-cigarettes either. Researchers from the ACS[6] found that flavours did not increase the attractiveness of e-cigarettes to teenagers. Rather, “Even after controlling for other statistically significant correlates, the odds of a smoker being willing to try an e-cigarette were 10 times those of a non-smoker.” Tobacco cigarettes are the gateway to tobacco smoking, not e-cigarettes.

Finally, there is no evidence to support your claim that e-cigarettes are used in significant numbers by people who have never smoked. ASH concluded that, ‘E-cigarettes are used by both smokers and ex-smokers, but there is little evidence of use by those who have never smoked or by children.’[7] In fact, recent research showed that just 0.1 per cent of e-cigarette users had never smoked tobacco cigarettes previously[8].

You stated that nicotine is addictive and highly dangerous.

Yes nicotine is addictive but that does not mean it is dangerous. Caffeine is addictive, is that dangerous? The nicotine contained in e-cigarettes is the same pharmaceutical grade nicotine used in NRT products (some of which are inhaled). As Professor Robert West said: “E-cigarettes are about as safe as you can get. We know about the health risks of nicotine. Nicotine is not what kills you when you smoke tobacco. E-cigarettes are probably about as safe as drinking coffee.”[9]

Professor Peter Hajek, Director of the Tobacco Dependence Research Unit at Queen Mary University of London, said: “E-cigarettes are orders of magnitudes safer than cigarettes because they do not release smoke which contains toxins which are responsible for heart disease, lung disease, and cancer.”[10] The NHS has also concluded that e-cigarettes are 1,000 times safer than tobacco cigarettes[11]. You should also note that many vapers use an e-cigarette that does not contain any nicotine.

You stated e-cigarettes are no more effective than nicotine patches in helping people quit smoking.

Many vapers have tried numerous times to quit smoking using conventional nicotine replacement therapies, which have a 90 per cent failure rate, and have failed, however with e-cigarettes they have all cut down their smoking or stopped completely. Professor Robert West said: “We found that those using the e-cigarette were about 60 per cent more likely still not to be smoking than those using the licensed product or nothing at all.”[12] E-cigarettes are however not some form of more effective nicotine replacement therapy, they are totally different and need to be regulated accordingly.

A key reason for calling for a ban on the use of e-cigarettes in public places would be if there was a problem with passive vaping. We note that you did not raise this issue in your response. Could this be because there is no evidence that passive vaping is a problem? In fact a major scientific study undertaken by Dr Konstantinos Farsalinos and Professor Riccardo Polosa concluded that the “effects of e-cigarette use on by standers are minimal compared with conventional cigarettes.”[13]

You also failed to raise the issue of what support your proposal has amongst the public at large. A recent poll by the BBC[14] found that 75 per cent of the public would be happy if their friends or family switched from smoking tobacco cigarettes to using e-cigarettes, and 62 per cent of the public said that e-cigarettes should not be banned in public.

On the specific case of banning the use of e-cigarettes in the work place, you may like to know that a number of pubs that had previously introduced a ban have now gone on to reverse the ban as new evidence has emerged. You may also be interested to know that Cambridgeshire Police, following a review of “health fears”, will allow their officers to vape at work[15]. We are confident that as the evidence continues to mount, a growing number of businesses and organisations will reverse their current bans. Far from leading on this issue, it would seem that this Welsh Government proposal would actually be a backwards step if it were implemented.

Smoking tobacco cigarettes kills over 5,000 people in Wales every year. We know that nicotine replacement therapies with their 90 per cent failure rate do not work. We also know that e-cigarettes are a safer alternative to tobacco cigarettes and that they enjoy widespread popularity amongst the public at large. You must see that it is clearly better for some to use an e-cigarette rather than a tobacco cigarette. As Professor John Briton from the Royal College of Physicians said: “If all the smokers in Britain stopped smoking cigarettes and started using e-cigarettes we would save five million deaths in people who are alive today. It’s a massive potential public health prize.”[16]

The rise of e-cigarette sales is directly contributing to a decline in tobacco cigarettes sales. In the words of Professor Robert West: “What is the problem that requires further regulation?”[17] What public health gain does the Welsh Government hope to achieve by banning the use of e-cigarettes in public? You failed to answer this question in your response.

With a ban on the advertising and promotion of e-cigarettes soon to be introduced, following the passing of the Tobacco Products Directive, where are smokers to find out about e-cigarettes, particularly if they are banned in public places? Smokers need to see people using e-cigarettes in public, they need to be able to go up and speak to e-cigarette users so that they can find out further information and then hopefully make the switch to a safer alternative.

Quitting smoking or cutting down on smoking is one of the most difficult things an individual can do. If the Welsh Government succeeded in having e-cigarettes banned in public places they will be forcing vapers to vape alongside smokers. We are in contact with vapers on a daily basis and many have said such a ban will simply force them back to smoking, is this really what you want? Surely you would rather people used e-cigarettes rather than tobacco cigarettes? Professor Antoine Flahault, Dean of EHESP School of Public Health (Ecole des Hautes Etudes en Santé Publique), concluded: “It is better to have an addiction to a behavior that is not harmful than to have an addiction to a behavior that kills you.”[18]

Yes e-cigarettes are relatively new, but new research, including long term studies, is being produced on a regular basis. Much of the recent research has rendered the arguments behind the Tobacco Products Directive redundant and out of date, and caused some policy makers to call for a rethink.

In its approach the Welsh Government are going against the precautionary principle as it was originally intended, you are trying to mitigate for a risk that has yet to be proven and in doing so may do more harm than good. As Professor Robert West said: “We have such a massive opportunity here. It would be a shame if we let it slip away by being overly cautious.” Professor Gerry Stimson, London School of Hygiene and Tropical Medicine and the National Institute for Health and Clinical Excellence, concluded: “It would be an appalling paradox if regulators, in the name of safety, ended up tipping the balance back in favour of cigarettes.”[19]

In your comments yesterday you were unable to provide one single piece of evidence for any public health gain arising from the Welsh Government’s proposals. We know from the evidence we have laid out in this letter, the experts we have consulted, and the vapers that we are in daily contact with, that should you succeed in implementing this ban that fewer people will make the switch from tobacco cigarettes to e-cigarettes. We therefore hope that following the consultation you will conclude that for the good of harm reduction there is no need to implement a ban on the use of e-cigarettes in enclosed public spaces, substantially enclosed public places, and places of work in Wales.

Yours sincerely

Save e cigs.

CC

All members of the Welsh Assembly

All Welsh members of the House of Commons

 

[1] http://metro.co.uk/2014/04/27/e-cigs-cleared-of-being-route-into-smoking-4710734/

[2] http://metro.co.uk/2014/04/27/e-cigs-cleared-of-being-route-into-smoking-4710734/

[3] http://www.ash.org.uk/files/documents/ASH_891.pdf

[4] http://www.ash.org.uk/files/documents/ASH_891.pdf

[5] Research undertaken by Professor Peter Hajek, Director of the Tobacco Dependence Research Unit at Queen Mary University of London

[6] http://www.jahonline.org/article/S1054-139X(12)00409-0/fulltext

[7] http://ash.org.uk/files/documents/ASH_715.pdf

[8] http://www.theguardian.com/society/2014/apr/28/e-cigarette-users-triple-ash-survey

[9] The Guardian Newspaper, 05 June 2013

[10] http://www.bbc.co.uk/news/health-27161965

[11] http://www.spectator.co.uk/features/9197731/vape-alarm/

[12] Study carried out on 5,000 smokers, by Professor Robert West looking at the success rate of different methods to stop smoking: nicotine gum, nicotine patches, nothing, or e-cigarettes. Reported on BBC Breakfast 28 April 2014

[13] Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review:

Konstantinos E. Farsalinos and Riccardo Polosa

published online 13 February 2014 Therapeutic Advances in Drug Safety

[14] http://www.bbc.co.uk/news/health-24909648

[15] http://www.cambridge-news.co.uk/Cambridge/Police-in-Cambridgeshire-can-smoke-e-cigarettes-after-health-review-but-they-are-banned-on-our-trains-20130821131920.htm

[16] The Independent Newspaper, 29 March 2013

[17] Professor Robert West speaking at the E-cigarette Summit, The Royal Society, London on the 12th of November 2013.

[18] http://www.youtube.com/watch?v=wTHGsTPklY4&list=UUAy2QbmqgmTUJ–CoK5J3xA

[19] Open letter to ENVI Committee members form Professor Gerry Stimson 22 April 2013

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Public Health Doctors and e-cigarettes – why this matters and what you can do

 

Guest post by Professor Gerry Stimson and Paddy Costal, Directors of Knowledge* Action* Change*

We struggle to understand why so many public health colleagues are anti-pathetic to electronic cigarettes.

The uptake of e-cigarettes has been a consumer-led public health revolution. At no cost to the NHS, and without government or public health support and promotion, thousands of people have found that e-cigarettes help them switch from smoking. Using e-cigarettes is a classic harm reduction approach – a safer product and delivery device for those who do not want to give up nicotine. It fits two public health principles – the first is to reduce harms to populations and the second is to engage and work with populations in their endeavour to lead healthier lives.

Many public health experts have in the past been strong supporters of harm reduction for illicit drugs. Indeed it was brave public health experts in a number of UK cities who took the reputational risk of promoting needle exchange and methadone treatment, in order to avert the spread of HIV infection. They took this courageous decision at a time when government was strongly “anti-drugs”. This pragmatic approach was met with some reluctance by the Thatcher government, but under the leadership of Norman Fowler – the then Minister for Health – harm reduction and “safer drug use” chimed with the other part of that AIDS response – safer sex. Odd then that some of those same public health leaders, and their successors, are not joining the ranks of those who support tobacco harm reduction.

Whenever the public health experts and organisations pronounce on e-cigarettes, we hear a recurrent refrain: e-cigarettes re-normalise smoking, they are a ‘gateway to nicotine addiction and smoking’, ‘the tobacco industry is involved’, ‘marketing of flavours is targeted at recruiting children’, and the promotion of e-cigarettes ‘glamorises nicotine’ in a way that smoking adverts glamorised smoking. This is accompanied by the reiteration of dubious claims – that ‘we do not know what is in them’, that ‘children are using them’, and uncertainties about their effectiveness as quitting devices. This is often accompanied by advice to patients and consumers to use the supposed effective treatments – ie NRT and varenicline.

Further obstacles are created to discourage use. For example, Public Health Wales has advised that their use in public enclosed places be prohibited in the same way as tobacco cigarettes are http://www.bbc.co.uk/news/uk-wales-25342539 and http://www.wales.nhs.uk/sitesplus/888/news/30545. All public health directors in Scotland have pronounced that they should not be used on NHS premises. Local public health teams likewise argue for bans. Fiona Godlee, editor of the British Medical Journal, has applauded the Bloomberg’s ban on e-cigarettes in public enclosed spaces in New York (http://www.bmj.com/content/348/bmj.f7686)

This reticence to embrace e-cigarettes has a number of drivers. First there is the antipathy of many public health experts regarding working with any industry to achieve public health gains. Some public health experts embraced Andrew Lansley’s “responsibility deal” which attempted to bring together public health and food and beverage producers, to no avail. Second is the long-standing anti-tobacco and anti-smoker mentality of public health and tobacco control organisations: for so long driven by being ‘anti-‘ it’s hard for some to switch into a positive mode. Third is the reluctance of public health and tobacco control organisations to engage with smokers, which spins over to reluctance and inability to conceive of engagement with vapers. Fourth, we think there is a bit of suspicion and jealousy because the e-cigarette movement did not emanate from medicine or public health, hence public health never felt it had “ownership” of the initiative. Fifth, it is not that the public health experts are lazy, but they have a large number of health issues to deal with, hence the tendency to adopt “narratives” from public health thought leaders. How else to understand how the same untested and unchallenged phrases crop up in different pronouncements?

This matters because despite what happens with the Tobacco Products Directive in Brussels, public health directors help set the tone for local public health responses. They are the authorities to which local policy makers turn. Hence a public health voice against vaping in public places is likely to be picked up and acted upon by local authorities, particularly regarding premises for which they are responsible.

What can you do? In England public health directors are now employed by and responsible to local authorities. This means they are responsible to your local councillors. Why not help your local authority be the first to support vaping?

Each local authority in England has its own Health and Well-being Board, which determines policy and priorities at a local level, within the overall framework set by Public Health England. Contact details and information on policies can be found on the local authorities’ websites.

In England, overall guidance for public health directors is the responsibility of Public Health England. Public Health England has yet to pronounce on e-cigarettes. The Director of Health and Wellbeing is Dr Kevin Fenton https://www.gov.uk/government/people/kevin-fenton. He has tweeted concerns about e-cigarettes @ProfKevinFenton. Time to write to him before any guidance is issued.

In Scotland, the Chief Executive of NHS Health Scotland is Gerry McLaughlin and you can find the board members here: http://www.healthscotland.com/about/board/members.aspx. At a local level policy and priorities are the responsibility of public health directors within the local health boards. Details of these can be found at http://www.show.scot.nhs.uk/introduction.aspx

In Wales the lead and author of the policy document is Dr Julie Bishop julie.bishop4@wales.nhs.uk. Details of local health boards in Wales can be found at http://www.wales.nhs.uk/sitesplus/888/page/44948

Whatever happens in Brussels regarding ‘regulation’ of the industry, e-cigarette use will also be determined by locally determined ‘rules’: make sure that your local public health doctors don’t come up with anti-vaping advice.

 

Professor Gerry Stimson and Paddy Costall – Directors of KnowledgeŸActionŸChange (http://www.kachange.eu/) and coordinators of Nicotine Science and Policy (http://nicotinepolicy.net/)

 

Gerry Stimson is also Emeritus Professor, Imperial College London, and Visiting Professor, London School of Hygiene and Tropical Medicine

 

How would YOU re write article 18?

Martin Callanan wrote that at the moment, the odds of e cigs being removed from the TPD are incredibly slim, and that our best chance to still be able to vape more than a ‘cigie like’ beyond 2016 is an amended article 18 – (the latest version is below this post).

MEPs have told us what they think, and we are very thankful to those that have worked so hard on our behalf. We’ve heard from experts in the medical field, in the Public Health field, both for and against e cigs, and again many many thanks to all of them that have stood up for our cause, but what  if we vapers could re write article 18 of the TPD?  What would we write? What would YOU write? What would you amend, and what would you introduce?

Because are the experts right? Is the average e liquid strength 18mg/ml? Do most people only use  2nd generation eGos, and  buy from the local shop? What about flavours? And what about the power the Commission are trying to award themselves in all this?

For the full version of the entire latest draft TPD – click here – (this will help you understand what articles 16, 6, 12 etc are all about.)

Have your say in the comments section below, and lets come up with the vapers article 18 that reflects us – the vapers. If you would  like to send us a more detailed response, then please e mail us at campaign@saveecigs.com. We will be collating all the responses and sending them to MEPs.

TITLE III – NON TOBACCO PRODUCTS

Article 18

Nicotine-containing products

Electronic cigarettes

(Presidency’s proposal)

(Text as submitted to Coreper on 13 December 2013 in doc. 17506/13 ADD2 with latest modifications indicated by strikethrough for deletions and bold underlined for additions)

1.         The Member States shall ensure that electronic cigarettes and refill containers are only placed on the market if they comply with the relevant provisions of this Directive and with all other relevant Union legislation.

This Directive does not apply to products that are subjet to an authorisation requirement under Directive 2001/83/EC or to the requirements set out in Directive 93/42/EEC.

 

2.         Manufacturers and importers of electronic cigarettes and refill containers  shall notify the products with the competent authorities of the Member States in which the product is intended to be placed on the market. The notification shall be submitted in electronic form 6 months before the intended placing on the market. For products already placed on the market on the date referred to in paragraph 1 of Article 25, the notification shall be submitted within 6 months of that date. A new notification shall be submitted for each substantial modification of the product.

The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:

  1. name and contact details of the manufacturer,  a responsible legal or natural person within the European Union, and, if applicable, the importer into the European Union;
  1. list of all ingredients contained in and emissions resulting from the use of the product, by brand name and type, including quantities thereof;
    1. toxicological data regarding these ingredients and their emissions, including when heated, referring in particular to their effects on health of consumers when inhaled and taking into account, inter alia, any addictive effect;
  1. information on nicotine dosing and delivery to blood streamand uptake when used under normal or reasonably foreseeable conditions;
  1. description of the components of the electronic cigarette; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;
  1. f.               description of the production process including series production and declaration that the production process ensures conformity with the requirements in this article;

 

  1. g.              declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.

Where Member States consider that data are incomplete, they are entitled to request the completion of such data.

Proportionate fees may be charged by Member States for receiving, storing, handling and analysing the information submitted to them.

3. Member States shall ensure that:

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;  to be used in rechargeable electronic cigarettes or in disposable electronic cigarettes

 

b)     the liquid does not contain nicotine in excess of 20 mg/ml;

c)      the liquid does not contain additives listed in paragraph 4 of Article 6;

d)     only ingredients of high purity and free from contaminants are used in the manufacture of the liquid; substances other than the ingredients referred to in paragraph 2(b) are only present in trace levels, if they are technically unavoidable during manufacture;

e)      only ingredients are used in the liquid that are not toxic hazardous to human health in heated or unheated form, with the exception of nicotine;

f)       electronic cigarettes deliver the nicotine doses consistently;

g)      electronic cigarettes and refill containers are child- and tamperproof;

 

h)     electronic cigarettes and the refill containers are protected against breakage and leakage and have a mechanism ensuring leakage free refilling.

 

4. Member States shall require manufacturers and importers to ensure that:

(a)   unit packets of electronic cigarettes and refill containers include a leaflet with information instructions for use and storage, including a reference that the product is not recommended for use by young people and non-smokers, contra-indications, warnings for specific risk groups, information on possible adverse effects, on addictiveness and toxicity, and contact details of the manufacturer or importer and a legal or natural contact person within the European Union;

(b)  unit packets and any outside packaging of electronic cigarettes and refill containers:

  1.                     i.       include a list of all ingredients contained in the product in descending order, and an indication of nicotine content and delivery per dose, the batch number  and a recommendation to keep out of reach of children;
  2.                   ii.       do not include elements or features referred to in Article 12, with the exception of paragraph 1(a) of Article 12 concerning the nicotine content;
  3.                  iii.       carry one of the following health warnings:

This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers.

 

or

 

“This product contains nicotine which is a highly addictive substance.”

Member States shall determine which of these health warnings are used.

 

(c)  the health warnings shall comply with the provisions in paragraph 2 of Article 11.

 

5. Member States shall ensure that:

a)      commercial communications with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited in information society services as defined in Article 1(2) of Directive 98/48/EC, in the press and other printed publications, with the exception of publications that are intended exclusively for professionals in the trade of the products and for publications which are printed and published in third countries, where those publications are not principally intended for the European Union market;

b)     commercial communications with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited in the radio;

c)      any form of public or private contribution to radio programmes with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers is prohibited;

d)     any form of public or private contribution to any event, activity or individual with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers and involving or taking place in several Member States or otherwise having cross-border effects is prohibited;

e)      audiovisual commercial communications falling under Directive 2010/13/EU are prohibited for electronic cigarettes and refill containers;

f)       cross-border distance sales of electronic cigarettes and refill containers are regulated in accordance with Article 16.

 

6.      Member States shall require manufacturers and importers of electronic cigarettes and refill containers to submit to competent authorities on an annual basis comprehensive data on sales volumes, by brand name and type, as well as information on preferences of various consumer groups, including young people, non-smokers and main types of current users, as well as the mode of sale of the products. They shall also submit executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.

Member States shall monitor the development of the electronic cigarette market as well as the market for refill containers, including any evidence of gateway use among young people and non-smokers.

7.      Member States shall ensure the dissemination of information received pursuant to paragraph 2 on a website with due regard to the protection of trade secrets.

Member States shall make available, upon request, all information received pursuant to this Article to the Commission and other Member States. Member States and the Commission shall ensure that trade secrets and other confidential information are treated in a confidential manner.

8.       Member States shall require that manufacturers, importers or distributers establish and maintain a system to collect information about all suspected adverse effects. If any of these operators considers or has reason to believe that electronic cigarettes or refill containers, which are in its possession and are intended to be placed on the market, are not of good safety or quality or is otherwise not in conformity with this Directive, the operator shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, as appropriate. In such a case the operator shall also be required to immediately inform the market surveillance authorities of the Member States in which the product is made available, giving details, in particular, of the risk to health and safety and of any corrective action taken, and of the results of such corrective action. Member States may also request additional information from the operator, for example on safety and quality aspects or any adverse effects.

9.      The Commission shall report on the potential risks to public health associated with the use of refillable electronic cigarettes at the latest on the date referred to in Article 25(1) and whenever needed thereafter.

 

In the case of products meeting the requirements of this Article, where a competent authority ascertains or has reasonable grounds for concerns that a given  electronic cigarette or a refill container, or a type of electronic cigarettes or refill containers, could present a serious risk to human health, it shall may take all appropriate measures and shall immediately communicate to the Commission and the competent authorities of other Member States the measures taken and any supporting data. The Commission shall determine, as soon as possible, whether the provisional measure is justified [following whenever possible appropriate consultations]. The Commission shall inform the Member State concerned, which will ensure appropriate follow-up.

Where, in the application of the first subparagraph of this paragraph, a given type of electronic cigarette or refill container, or a type of electronic cigarettes or refill containers has been banned on justified ground by at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to extend such a ban to all Member States, if that measure is justified and proportionate.

10.    The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the wording of the health warning in paragraph 4(j). When adapting that health warning, the Commission shall ensure that it is factual.

 

11.    The Commission shall adopt by means of implementing acts a common notification format pursuant to paragraph 2 and the technical standards of the refill mechanism.

         These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.

1.      The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:

(a)    products with a nicotine level equal to or exceeding 1 2 mg per unit, or

(b)   products with a nicotine concentration equal to or exceeding 2  4 mg per ml. or

(c)    products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.

2.      The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to update the nicotine quantities set out in paragraph 1 taking into account where this is necessary based on scientific developments and marketing authorisations granted to nicotine- containing products pursuant to Directive 2001/83/EC.

3.      Each unit packet and any outside packaging of nicotine-containing products below the thresholds set out in paragraph 1 shall carry the following health warning:

This product contains nicotine which is an addictive substance and can damage your health.

4.      The health warning referred to in paragraph 3 shall comply with the requirements specified in Article 10 8(4). In addition, it shall:


(a)    be printed on the two largest surfaces of the unit packet and any outside packaging;

(b)   cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion size shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.

5.      The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the wording of the health warning requirements in paragraphs 3 and taking into account based on  scientific and market developments and to adopt and adapt the position, format, layout, designand rotation of the health warnings.

5a.   The provisions of of paragraphs (3) to (5) of this article shall be without prejudice to the application of Directive 2001/83/EC.

6.      Nicotine-containing products referred to in Article 18(1) and which are placed on the market before [entry into force + 24 months], may continue to be marketed until  [entry into force + 36 months].]

Now you have read it – have your say in the comment section.

Musings from a vaping Scottish MSP

 

Guest post from Mike Mackenzie, MSP.

I like smokers. They are honest. They aren’t hypocritical. They aren’t afraid to admit they have faults. They don’t pretend to be perfect. Having at least this one very public fault, they are often understanding and tolerant of the faults of others.

I used to be one. Not a part time smoker, not an occasional smoker, but a hard bitten, life long, full blown smoker. I smoked roll ups. I didn’t use filters. I smoked an ounce of tobacco every day for over thirty years. I enjoyed every lungful.

Tobacco was my best friend. It was with me in the best of times and the worst of times. I never had a cup of coffee without a cigarette. I never had a glass of whisky without one. In triumph or disaster a cigarette was called for or came to the rescue, reassuring and consoling. Every problem had a solution when a cigarette was at hand.

Smokers often have this reflective quality. They don’t panic or lose the plot in the face of problems. They light up. They inhale. They think. They are philosophical in the face of all the ups and downs of life and all of its uncertainties.

My addiction as you may have gathered was by no means only physical. I started smoking at 12 years old; just an occasional secret fag shared with friends. Until I left school I was a weekend smoker only, but I got going in earnest when I went to University. I rolled cigarettes without conscious thought or effort. I could roll them in the dark or riding a bike. I could roll them with one hand if a party trick was called for.

Newly elected in 2011, perhaps because of the stresses of a new job, perhaps because of the amount of driving I was now doing, I found I was smoking more and getting less exercise. I began to think about cutting down my smoking. As a lifelong fitness fanatic friends were often confounded at the apparent anachronism I presented. I would breakfast on two cups of coffee and four cigarettes and then head off to the gym or go for a run. I kidded myself that somehow being fit would protect me against the worst effects of tobacco.

Perhaps it did but when I turned fifty I began to notice these effects. I couldn’t run as fast or as far. I couldn’t yet feel his hot breath on my neck but I began to sense the grim reaper gaining ground on me. Still I didn’t want to stop smoking. I didn’t want to abandon my lifelong friend. It was merely as an aid to cutting down that I thought I would give e-cigarettes a try.

Within two days and without really wanting to I had stopped smoking altogether. Eighteen months on I feel ten years younger. I get less exercise than I used to but I feel fitter. I have more energy, I sleep less and my powers of concentration have increased. Friends say I look younger.

Nicotine, as drugs go, is benign. It may even have some beneficial properties. How else do you explain our five hundred year habit of smoking? It was always the delivery system that was at fault, but even wrapped up in the cancerous cocktail of tobacco, for many people the pros still outweighed the cons. They chose to smoke knowing the risks. Life, after all, is not merely a competition to see who can live the longest.

Still the health costs of smoking tobacco are high, far too high and the technological solution, the e-cigarette, is one of those triumphs of the ingenuity of humanity. It gives me hope that we will solve many of our other problems.

The debate surrounding the regulation of e-cigarettes, is perhaps inevitable, but it has some unfortunate undertones. Those with little understanding seek to ban them or regulate them out of existence. Often these are the same people who have campaigned so avidly against tobacco. The logical inconsistency of holding these two antipathies seems lost on them. There is risk that the baby will be thrown out with the bathwater.

Proponents of e-cigarettes should see regulation as an opportunity. Proportionate and reasonable regulation will put many of the fears to bed. For responsible manufacturers it will provide a quality hallmark and for consumers, confidence that their health is not put before profit. It is not regulation itself which is bad but bad regulation and care should be taken on both sides of this argument that such regulation that emerges is as good as it can be.

European Union regulating e-cigarettes based on ideology and theories, but not science

Guest post by Dr Farsalinos

It is unfortunate for a scientist to see how politics work and how decisions are made. For public health issues, especially for the very sensitive issue of smoking, one would expect that common sense and scientific facts would prevail. Instead, we are seeing decisions made on the basis of theoretical concerns, fear-mongering tactics and intimidation.

The pending regulation for electronic cigarettes seems to be a characteristic example of applying theory on top of real evidence. There has been an astonishing effort to mis-present science, misinform regulators and the society by distorting the results of scientific studies and eventually kill a product which will probably revolutionize tobacco harm reduction. Recently, we are overwhelmed by stories demonizing nicotine. Suddenly, after so many years of research and hard evidence coming from population studies, we are seeing the news media discussing about nicotine causing cancer and heart disease. We are seeing journalists trying to interpret cell studies, while in reality I doubt if they understand a single word of what they read. Obviously, they should not be the only ones blamed; it is scientists who give the information to the news media and they push for publicity. The result is a complete distortion of truth. It is shocking to see someone support that a cell study is good enough to discard all hard evidence from population studies showing that nicotine does not cause heart disease or cancer.

However, there are other questions raised by such tactics. First of all, why is every study on nicotine targeting e-cigarettes? Don’t NRTs also have nicotine? Why don’t we hear anyone discussing about nicotine in NRTs? Well, probably because e-cigarettes are a hot topic. However, few years ago, studies showing nicotine to be harmful were strongly opposed by scientific groups (such as Cancer Research UK), stating that: “The interpretation is highly speculative and contradicted by evidence that many millions of people have been using nicotine replacement therapy with no increased risk of oral or any other cancer. If reports like this stop people using what for many would be a life-saving medication it would be very unfortunate.” They are absolutely correct, but the same statement should be done today for e-cigarettes.

All this intimidating publicity has only one result: it harms the health of smokers by discouraging them from using a less harmful alternative like e-cigarettes and it harms the health of vapers some of whom have relapsed to smoking after hearing all this misinformation.

Coming back to regulatory decisions, it is unprecedented that a product is regulated based on theoretical concerns, especially when such concerns are completely contrary to any available evidence. It is a big “victory” of the antismoking advocates (who in fact have become anti-smokers) that the agenda is not evidence but theories; theories about normalization, theories about use by youngsters, theories about health effects. Every scientific study shows the exact opposite from what they support, but none cares. Theory is more important that evidence. We have come up to a point when a professor is supporting that “We are witnessing the beginning of a new phase of the nicotine epidemic and a new route to nicotine addiction for kids” while at the same time his own study mentions that “Students who had smoked every day in the past 30 days had the highest rate of current e-cigarette use (50.8%), compared with .6% among those who not currently smoking cigarettes (p < .001).” (emphasis added).

How should this be called? Science? It is really sad that scientists are so disrespectful of smokers and their need to find a getaway from smoking. They believe they should be punished for initiating smoking and for medicine’s inability to develop an effective smoking-cessation medication. It is a dangerous path that should be condemned.

Regulators should stay away from propaganda tactics. They should be properly informed and base their decisions on facts, not on theories. Regulating based on anything besides evidence is like opening the floodgates; it will have severe consequences and will definitely harm public health.

 

Swedish Administrative Court rules e cigs are not medicinal!

A new ruling by the Swedish Administrative Court  this week stated that electronic cigarettes are  NOT  a medicine, and so do not need to be regulated as such.

That takes the total  to eight courts in Europe that have ruled e cigarettes are not medicinal.

Last spring the Swedish Heath Regulatory Agency/ Authority called the MPA stated that any electronic cigarettes that contained nicotine needed to be approved as a medicine and be licensed accordingly.

However, one company in Malmo decided to ignore this and sold e-cigs until the MPA threatened  them with a 700,000 SEK fine, and shutting down their business.

Not one to be outdone by proposed ridiculous laws made up by agencies , the e cig company in question appealed to the Administrative  Court.  The Court had a look at the facts, as the law must – and hey presto – The facts cleary show that  electronic cigarettes are not  a medicine, and therefore do not need to be approved as such.

Let’s hope that those in Trilogue at present within the EU, especially the Council and Commission and Lind McAvan the rapportuer, are aware of this new ruling, plus the other 7 court rulings that clearly state that e cigarettes are NOT a medicine. We hope this is at the forefront of their minds  while they negotiate the TPD and amendment 170.

Meet the Team

Meet the team

Having been up and running for a couple of weeks now, I thought it would be an idea to introduce some of the people supporting this campaign, what we are doing, and why.

At the moment we are a merry band of three – Katie, Sue, and Johnny.  I (Katie) am a freelance writer and former midwife, Sue is mum to three gorgeous kids, and Johnny is a small independent retailer of e-cigs.  We are also supported by Richard who is kindly giving us some advice and support with the campaign.

Why this campaign?

Either as e-cigarette users or because we see the benefits e-cigarettes bring to our friends and family, and by association us, we felt it was important to put together a campaign that would hopefully unite e-cigarette users, their friends, and their families under the one banner – for all our sakes, save e-cigs.

How have we managed to fund all of this?  To be honest, we haven’t had to spend any money to date.  What we have done is nag, cajole, and blag from friends, colleagues, family, and people who support the campaign.  As a result we have this website and we have our campaign letter translated into a number of languages.  Now if your countries language has not been translated (blatant ask coming up…) please do feel free to translate for us and send it to us.  The more letters we have translated the more likely we are to succeed.

As I mentioned, we have some support on the campaign side from Richard.  This has turned out to be invaluable, though e-mailing all the MEPs has been a complete labour of love – (I should probably include the play list here that kept me going – but suffice to say Queen ´We are the Champions ´was one of them.)

We are a group of people who care deeply about e-cigarettes and the way they are transforming people’s lives for the better.  We can see very clearly that medical regulation is the wrong path to journey down!

How can you help?

We need as much help and support as we can get.  Please follow us on Twitter, like us on Facebook, and sign our letter.  Once you have done this please, please, please, share this with your friends, colleagues, and family.  Please encourage them to all support this campaign.

Time is not on our side as we are delivering our letter to MEPs in Brussels next week, is it really that soon?!  Alongside the delivery we will be organising a few other things so watch this space for further details.

Again, please help, please sign, and please, please share!