Open letter to Martin Schulz, President of the European Parliament.

Dear President,

We write on behalf of e-cigarette users (vapers), their friends, and their family from across the EU, in support of the ECR Group’s request to have the Tobacco Products Directive (TPD), agreed in trilogue and approved by the ENVI committee, opened up for split and separate votes.

As vapers, public health experts, and electronic cigarette manufacturers, from across the EU, have all made clear, the TPD in its current incarnation is deeply flawed.  As an example, the current version of the TPD would ban the labelling of e-cigarette and e-liquid flavouring.  How will producers of flavoured e-cigarettes and refill containers label their products?  How will users know what they are buying, storing and using?

This is just one example drawn from a very long list that not only makes the TPD undesirable in parts, but also genuinely unworkable.  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.

If any credibility is to be salvaged from this whole process, it is vital that these genuine concerns are heard in the European Parliament.  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.

In October a majority of MEPs from across the political spectrum voted in favour of amendment 170.  The TPD that MEPs will vote on in March is significantly different to what a majority of MEPs previously supported, and therefore no matter what you or individual members may feel personally or politically, the European Parliament can only, if it is to maintain its integrity and authority support the ECR Group’s request.

Save e-cigs.

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UK Gov bans e cig sales to under 18, so why did they support in Council an amended TPD that did not contain such an age restriction?

Today, the Government announced, via a press release  that they would be banning the sale of e-cigarettes to under 18 year olds.  This is welcome news.  Save E-cigs have been calling for this for months and responsible vendors have been doing this for years despite the lack of legislation.  E-cigarettes should not be sold to minors or non-smokers and we are delighted that the Government now agrees.

If however, this is the Government’s long held view, why did they support in Council an amended TPD that did not contain such an age restriction?

Despite welcoming the Government’s announcement, we seriously question the manner in which it was made.  Once again, the Government used this opportunity to peddle their standard misinformation regarding e-cigarettes.  We were told that this policy was being introduced to prevent children buying potentially “toxic” e-cigarettes.  That it was a response to “concerns that growing numbers of children are taking up e-cigarettes, before becoming addicted to nicotine and moving on to regular smoking.”  Most worrying of all, we were told that ministers had been moved to act following “anecdotal” evidence that e-cigarettes were gaining in popularity, with some reports of children smoking them in class.

Now we support this announcement, we called for such restrictions when the Government was not supportive, but legislation based on “anecdotal” evidence is very worrying.  Now let’s look at those government statements in a little more detail.

Research, including a recent survey commissioned by ASH[1], has shown time and time again that e-cigarettes are not attractive to young people, and are therefore not used as a gateway to smoking tobacco cigarettes.  Although awareness of e-cigarettes was widespread amongst young people aged 11 to 18, the ASH survey found no evidence that young people either used or perceived e-cigarettes as being a gateway to smoking.

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, especially the young, as they have no interest in the product.

Researchers from the ACS[2] looked specifically into the enticement of flavours.  They 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.

As for the claim that e-cigarettes are potentially “toxic” and that we do not know what is in them, well again this is just not true.  We do know what is in them, PG, VG, nicotine, and flavourings.  Again many responsible manufacturers test their e liquid so they and we know exactly what is in them.  Only two weeks ago a group of vapers set up a crowd funding website to raise money to fund further independent testing.  We know that responsible manufacturers have also contributed.

These facts are readily available to anyone who cares to look, and Save E-cigs and countless others have been making policy makers aware of them for months.  Why then do the Government continue to peddle this misinformation and why do journalists publish them unquestioningly?  After all, the Government provide no evidence to support their claims; in fact they admit their evidence is “anecdotal”.

All this government misinformation and sloppy journalism does is scare people and encourage them to continue smoking tobacco cigarettes rather than switching to the safer e-cigarette.

So we welcome the fact that the Government has finally agreed to introduce age restrictions for the sale of e-cigarettes, but can government please, please, please stop making policy based on anecdotal evidence and instead start basing it on readily available independent factual evidence.  Is that really too much to ask?

 

[1] ASH surveyed 12,597 adults in 2010 – the questions focused on e-cigarette use and awareness in Great Britain. The preliminary survey was followed up by an additional study of adult smokers and non-smokers in February 2012 and more recently in 2013. ASH also surveyed children and young people aged 11 to 18 in March 2013.

Open letter to MEPs from the American trade association SAFTA

January 21, 2014

Dear MEP,

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

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

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

A. Ban extension on refillable products

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

B. Consistent Dosing Requirement

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

C. Limits on Nicotine Levels

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

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

E. Cross Border Sales Ban

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

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

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

Kind regards, Cynthia CabreraExecutive Director, SFATA

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

 

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.

 

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.

TPD timeline, what happens next and what we vapers can do…guest post by Martin Callanan MEP.

martin-callanan

As with most trilogue meetings between the Parliament and the Council (in this case represented by the Lithuanians in the rotating chair), the tobacco talks started in the evening and concluded in the early hours. What came out of them was perhaps better for vapers than we first feared, but it is still far too prescriptive and restrictive for me to be able to support it.

The infamous Article 18 is now so long it is practically a directive in itself. In many cases it will allow national governments to maintain the status quo and classify e-cigs as medicinal products, and potentially even ban flavourings.

Refillables will be hardest hit. An EU ‘elf and safety review will take place in 2016. But it probably won’t be needed as the legislation allows the Commission to extend a ban across the EU if just three Member States apply a ban. This dagger hanging over the industry’s head is unacceptable.

Products will also be limited to a nicotine strength of 20 mg/ml. For someone moving off of a serious habit, such a small dose risks just sending people back on to hard cigarettes. We would want to see at least the 30mg limit set out in parliament’s vote in 2013.

Ok, so that’s what we don’t like. Unfortunately this agreement was agreed by representatives of national governments a few days after our meeting. Personally, I was disappointed to see the LibDem MEPs – who had fought alongside us to date – claim that this deal was a good one for e-cigs. It’s not too late to change their minds. And with elections coming you may be able to sway others too. But it will need the vapers of Europe to really step up their pressure on MEPs. The timeline is as follows (although it isalways likely to change):

1) In accordance with the Parliament’s Rule 70.5, the single vote on this compromise agreement will be scheduled in the environment and public health (ENVI) committee on 22 January 2014. A simple majority of MEPs is needed for the committee’s consent on the negotiated text.

2) Following the vote in the ENVI committee, the agreed text must then undergo a further legal-linguistic verification, which can take several weeks before the recast TPD is translated into the 24 official and working languages of the European Union.

3) The compromise text is then expected to go the plenary in Strasbourg inMarch 2014.

4) If the report is adopted in the ENVI committee with fewer than one-tenth of MEPs voting against, the report will go under Rule 138 at plenary. This means that the report shall then be subject to a single vote unless, before the drawing up of the final draft agenda, political groups or individual Members who together constitute one-tenth of the MEPs have requested in writing that the item be open to amendment, in which case the Parliament’s President shall set a deadline for tabling amendments.

So we do have options open to us. As it’s unlikely we will get sufficient votes to reject the whole directive outright in committee, the best course of action, in my view, would be to collect enough signatures (76) to enable amendments to be tabled at plenary, and then to reopen Article 18 with amendments to make it more sensible. Getting these amendments passed would require a Herculean effort from vapers right across Europe. You’ll be fighting against enormous and powerful lobbies from big tobacco to national governments. Conservative MEPs and the ECR Group will be on your side and we will keep working to bring other support behind your campaign. But we can’tdo this alone. This battle is not yet lost.