Eu commission proposal for the regulation of e-cigarettes

Below is a copy of the email newsletter that we sent out yesterday evening, concerning the latest state of play regarding the EU Commission and e cigarettes.

Dear ezSmoke Customer,

First off I apologise for «flooding» your Inbox, but after sending out an email offer this weekend, I did not expect to be sending another email so soon after. But this email is much more important, than any email offer that I may send. Rather than restate what is happening at EU level at the moment, I think if you read letter below that I sent to some Irish MEP’s, you will get a very good idea of what is happening.

I strongly urge you to contact / write to your local MEP, and let them know how the new proposals outlined below, will affect you. Find your local MEP here

Dear (MEP),
As you are aware on October 8 of this year, the EU Parliament voted to NOT make ecigarettes a medicinal product. The Key Points were

  • Maximum of 30mg/ml of nicotine in eliquid
  • Products should carry health warnings
  • Products should not be sold to anyone under 18 years old
  • Manufacturers and importers would also have to supply the competent authorities with a list of all the ingredients that they contain
  • E cigarettes would be subject to the same advertising restrictions as tobacco products

As an electronic cigarette user and vendor, I broadly welcomed this sensible decision by the EU, and truly believe that many 100,000&#8242 s if not millions of lives throughout the EU will be vastly improved and lengthened by proper implementation of this legislation. However, today I have learned of a new document (link ) which is to be used as the basis for discussion for ecigarette policy in the TPD.

From my understanding this is in fact a «Confidential» document, but I am extremely concerned with the contents of same. As ex director of ASH UK, Clive Bates states on his blog «Make no mistake, if implemented this proposal bans every product on the market today and would severely limit options for future products

The main worrying points of this new document are (with my brief objections in brackets)

  • Allows only single use cartridges. No refillable units will be permitted. (This is the system that vast majority of my customers use.)
  • Allows only flavours already approved for use in NRT. (The wide variety of flavours is what encourages many smokers to make the change to vaping.)
  • Limits nicotine density to 20mg/ml (I could handle this, but many customers would not be happy)
  • Limits nicotine content of any container to just 10mg/unit (This would only make eLiquids / Refills more expensive does not make any sense from a health perspective)
  • Allows only devices that deliver nicotine doses consistently and uniformly (This is practically unworkable)
  • Bans all advertising in press or printed publications (except trade), on radio, TV and other audiovisual services and the internet through information society services (You can’t ban the Internet or what people say online!)
  • Asserts that e cigarettes simulate smoking behaviour and are increasingly used and marketed to young people and non smokers . (Evidence to date suggests that this is patently not true.)

There are other proposals, that I would also have issue with, but above are the main ones. Although the EU Commission voted NOT to regulate e cigarettes as medicines, many of the proposals in the document seem to be doing the exact opposite, whilst at the same time adding the MOST RESTRICTIVE commercial restrictions that are already in place for tobacco, eventhough electronic cigarettes are of a magnitude safer than tobacco.

If these proposals go through, millions of smokers and vapers throughout Europe will be consigned to an early grave. I understand that there is great pressure on the EU Parliament to proceed with the Tobacco Products Directive, and as mentioned in previous correspondence, I don’t have any great issue with the main parts of this directive. But, if such stringent rules and in some cases nonsensical rules are applied to e cigarettes in the directive, then the Directive as a whole will be the greatest Public Health failure in the history of the European Parliament.

I urge you to contact your fellow MEP’s and persuade them of the enormous benefits of the original decision on October 8, and to remove the contentious points in the new proposal. If this is not possible, then I would advise that e cigarettes are completely removed from the TPD, and that new legislation specifically for Electronic Cigarettes is pursued, as e cigarettes do not fit in well with either Tobacco or Medicines regulation, as they are a completely new and unique product.

Yours Sincerely,

Declan Connolly.


Cartron Road,
Kinvara
Co. Galway
Ireland

T 091 637500 / 087 7972811
E sales
W

Will eu bureaucrats kill artificial cigarettes off?

Government plans on licensing electronic cigarettes have been delayed even further amid fears for the future of the embryonic industry in Britain. Worryingly the European Union is also proposing a regulation requiring devices containing more than 4mg of nicotine to be regulated as a medicinal product.

By Pat Harrington

MEPs are expected to vote on it in September. Katherine Devlin, president of the Electronic Cigarette Industry Trade Association (ECITA), claims that supporters of reclassification have a vested interest in rival pharmaceutical products. She is lobbying MEPs to reject the EU proposals. «The plans would effectively kill the industry,» she said.

In a position paper prepared for the European Parliament, ECITA states

1. The Electronic Cigarette Industry was created and developed entirely separately from the Tobacco and/or Pharmaceutical Industries. It is made up of consumer driven SMEs, not giant multi national corporations, and provides local employment, economic growth and tax revenues. The proposals as currently drafted would give a significant boost to the Tobacco Industry, by driving our millions of customers back to smoking.

2. Reclassifying these consumer products as medicinal products would have a negative impact on public health, because it would require a change in the operation and performance of the products, and would reduce their appeal and effectiveness for consumers. It is also illegal, as demonstrated very clearly by 4 specific case precedents, and several others from other sectors, across the EU.

Ecigs are designed to operate as a like for like replacement for smoking. This makes them a poor fit for medicines regulation which is largely concerned with controlled dosage and specific means of administration. Just as people don t smoke in the same patterns, so ecigs are used in an individual manner. Making them more like a medicine would make them less like smoking, thereby reducing their appeal and effectiveness.

3. One UK company has tried to get a Marketing Authorisation (MA) for its product, specifically wanting to make the medicinal claims about quitting. Their experience has made both the industry and the consumers very worried about this approach. This company has been engaged in the process for over 3 years now they declared last year that they had spent 2m so far and they still have not received a MA.

«If the revised TPD were adopted concerning ecigs, the products would have to be removed from the market until the MA is granted. Consumers and distributors are worried, therefore, that medicinal regulation will restrict availability. Indeed, the vast majority of EU consumers view medicinal regulation as tantamount to a ban on the products

Nick Griffin, MEP, commented «The proposal is likely to effectively ban a useful product. I am very much opposed to this measure and support the industry in opposing it. It is another unwarranted attempt by the EU to fix something which is not broken


5 комментариев to “Eu commission proposal for the regulation of e-cigarettes”

  1. BRUSSELS Should electronic cigarettes be regulated as tobacco pro

    • the sales compliance rate at licensed retailers is very, very high already we just don t think that s the right approach, Mr. Sutton said. As for the ban on discounts, Mr. Bloomberg, who is accustomed to setting an example for other municipalities in public health initiatives, from smoking bans to c

    • educe smoking related deaths even though long term effects are unknown. In the journal Addiction, researchers suggest e cigarettes should face less stringent regulations than tobacco. But experts warn encouraging their use without robust evidence is "reckless". Instead of inhaling tobacco smoke, e c

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