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From the Totally Wicked FB Page

Discussion in 'Health and Legal Information' started by VapeMeStoopid, Sep 3, 2013.

  1. MHRA confirms e-cigarettes are not medicinal products – but they still face a ban!


    Totally Wicked has obtained written confirmation from the Medicines and Healthcare Products Regulatory Agency (MHRA) that none of its current product range is a medicine or a medicinal device, and that it does not need to obtain medicines marketing authorisations for its products. Notwithstanding that, the MHRA has stated that if MEPs vote for the EU's draft Tobacco Products Directive (TPD) in its current form on the 10th of September, it will require Totally Wicked from 2016 to market the same products as medicines and obtain such authorisations. In other words, it would have to seek medicines licences for products the MHRA has confirmed are not medicines. This is the clearest statement yet that currently available e-cigarette products will be banned from 2016 if the TPD passes into law.


    Asking for clarity on the intentions of the MHRA, as stated by them on the 12th of June 2013 to regulate ‘nicotine containing products’ in line with the proposed EU TPD, Totally Wicked’s lawyers this week received a reply to a litigation letter of claim.


    Confident of the fact that its products are not medicinal, Totally Wicked has been proven right and the MHRA has confirmed that currently, under the Human Medicine Regulation 2012, and the Medicinal Products Directive 2001/83/EC, none of the products sold by Totally Wicked as of the 22nd of August 2013 are considered medicinal, nor are they considered medical devices under the Medical Devices Directive 1993 (Directive 93/42/EEC).


    As a result of this confirmation, Totally Wicked is not required to seek marketing authorisations or any other form of license for its products. However, in their reply, the MHRA stated that if the draft TPD passes into law in its current form, Totally Wicked, in order to legally sell its current product range, would be required to seek marketing authorisation from the MHRA under the Medicinal Products Directive.


    Having established that none of Totally Wicked’s product range qualifies as a medicinal product, it would be impossible for Totally Wicked to obtain authorisations and as a result it would be prohibited in law from selling any of its existing products.


    As Totally Wicked’s product range is broadly similar to that distributed by other electronic cigarette vendors in the UK, the logical conclusion to draw from the above is that if the draft TPD passes as proposed, there will be a shutdown of the general sale of currently available electronic cigarette products from 2016 throughout the UK.


    Perversely, the MHRA also confirmed in its reply, that it accepted that conventional tobacco cigarettes are “capable” of being regulated as medicinal products, but that it does not intend to include these nicotine containing products within the proposed new regime. Accordingly, conventional tobacco cigarettes, which are responsible for the deaths of 700,000 people across the EU each year, will not be subject to the same de facto marketing ban faced by electronic cigarettes


    Should the TPD be passed as proposed, Totally Wicked will mount a legal challenge, domestically and at EU level as a result of the perversity of being forced to make a medicinal claim for a confirmed non-medicinal product, while tobacco companies continue to sell their own nicotine containing products unimpeded by the medicinal regulatory regime.


    Fraser Cropper, Chief Executive of Totally Wicked said,


    “Since the commencement of the MHRA’s consultation in 2010 our company and our customers have made it very clear that our products were not and could not be legally or ethically classed as medicinal products. Electronic cigarettes are transforming smokers’ habits by the thousands each week. That our government and its regulators are knowingly attempting to destroy this product’s utility, whilst continuing to endorse the on-going endemic of tobacco availability, is one of the most incredible and concerning matters of our time.”


    MEPs will vote on these proposals on the 10th of September 2013.
     
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  3. Tubbyengineer

    Tubbyengineer Legend

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    Now we know why their products cost more, legal bill's must be awful. But that said I'm glad TW are prepared to go the distance on this, even if it is to ensure they still have a market for their products...
     
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  4. 6027david

    6027david Postman

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    It's not fair minded and neither does it make sense. Welcome to the ' Common Market'. Erm! does anyone on the forum remember voting to be in that? Very, very many years ago it was supposed to be a trading policy to help farmers.
     
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  6. 6027david

    6027david Postman

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    The 'Totally [email protected] site helped me to get into vaping and off the stinkies. Yes, they are a bit pricey, but they do have regular sales, which makes their stuff competitive. I will support them while ever they are actively promoting the freedom of choice we, as responsible individuals, are entitled to as a basic 'Human Right'.
     
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  7. Fleabag

    Fleabag Achiever

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    We need some big players in the field to be able to legally challenge. Though it acknowledges that the products we currently use won't be able to be licensed, it does also make the idiocy of this law all the more obvious.
     
  8. Tubbyengineer

    Tubbyengineer Legend

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    Yep, me too, I started with a TW Tornado T, then bought an TW Odyssey, now I have an SVD on which I'm vaping TW's Raspberry Menthol and am giving the Tornado to a friend so he can start vaping too. BTW, I've been vaping for the mind numbingly long time of 3 weeks...:rofl:
     
  9. Purplefowler

    Purplefowler Administrator Staff Member

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    I too started with TW products :) now I'm going to say something that, after "certain" things that have happened historically, I never thought I'd ever say but.......go TW! If anyone knows how to manipulate the law to its benefit (and every vaper out there) it's TW! It will be very interesting to see where this one goes, definately one to keep a close eye on.
     
  10. Tim

    Tim Postman

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    I started Vaping (propper) through TW aswell, and still use their fluids and concentrates to make my juice.
    What I think they excel at is providing a one stop shop for new vapers, and excellent customer service I am speaking from experience here in that I had a couple of items that weren't up to the standard I thought, an ego battery, and some cartos on both occasions these items were replaced over the phone at no cost. I own an odyssey and am very happy happy with it.
    That said once you start to look for somthing a bit different then the range does become a wee bit limited, but that's just the nature of things JC very successfully tapped into the market when it was in its infancy, and weather you love hate or an indifferent to the man, you have to give him credit for that and his passion for the brand ( I know he does very well off it but at starting point he had not a lot). Historically I agree some stuff has occurred that isn't great, but not knowing all of it I'd not like to comment.
    In regard to TW today?... Well it seems that new management is expanding the range, the sales and yoyo are still making their prices competitive and as far as I can see customer service is still good, I've no complaints and will continue to support them, not least because they are actively battling Europe and ecigs becoming medical products.

    i hope it's not to ranty, its not meant to be, rather just my perspective on things
     
  11. Mark

    Mark Legend

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    Perversely it can pay to befriend a bully...they have the wad to fund the fight so I'm prepared to stand behind them and say..yeah! EU! What he said!


    For now..
     
  12. Reevo

    Reevo Achiever

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    "now I'm going to say something that, after "certain" things that have happened historically, I never thought I'd ever say but.......go TW! If anyone knows how to manipulate the law to its benefit (and every vaper out there) it's TW!"
    Oh yes I remember the Jacqui days well! Lets hope their legal team win this one for the right reasons this time!
     

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