Thursday, 19 December 2013

Hoodwinked ! Article 18 is medical regulation in disguise (guest post)

Guest Post by 'Evaporate' - UKV member

This is a guest post by Evaporate, a member of the UK Vapers Forum, who explains why Article 18 is the same as medical regulation of e-cigs - a defeat, as if amendment 170 never happened.

 Don't be fooled, article 18 of the Tobacco Products Directive, which can be read on Clive Bate's website is the same as medicinal regulation for electronic cigarettes.

Vendors must inform the competent authority within 6 months of marketing
  -  The competent authority is the MHRA.

The information required is toxicity, emissions on heating, inhaled health effects and inter alia (meaning amongst other things) addictive effects, Also required is nicotine dosing and uptake under foreseeable conditions. 
  -  This data can only be obtained from lab experiments and clinical trials.

This is effectively market authorisation data.

This data plus manufacturing process data, also required, is normally provided on a product dossier for each product.

If the MHRA find fault, they could say the data is inadequate and does not comply with the directive, stopping marketing or removing from sale.

Section 8 requires market surveillance data and adverse reaction reporting, this is called pharmacovigilance in medicinal regulations.
Section 9 gives (Medical) authorities power to ban a device
Section 5 limits free speech

Unless MEPs realise that these are medicinal regulation they will not see they are being fooled.



  1. But...
    It isn't an authorisation procedure - it is a notification regime
    It doesn't require pharma Good Manufacturing Practice (extremely expensive and disruptive)
    It doesn't limit sales to only where pharma can be sold
    How do you know the MHRA is the competent authority? Even if it is, what matters is the regulation it has to apply and powers it has
    Some of the data requirements are the same for cosmetics
    Some of the data requirements are reasonable
    Using power to ban a device has to be justified and proportionate
    There is a lot of arguing over detail still to be done.

    None of this is to argue:
    1. That the directive is any good - it is a mess
    2. That it won't have negative consequences overall - it will
    3. That it was made in an acceptable way - it is shocking how it was done

    See my take on it here: Making sense of the proposed new e-cigarette regulations.

  2. Good points, Clive, but it is pretty plain to see that even this is not what the EU wanted.
    They want rid of ecigs.

    The forces within the EU have demonstrated that couldn't give a fig about democracy on this issue, nor do they pay attention to logic. They have an agenda.

    The other thing they have demonstrated is that things will only get worse. They will not put these rules in place and then relax them as time goes on. They will tighten them

    It isn't an authorisation procedure (yet) - agreed - but they have lost all trust in their ability to create good legislation on this issue, and this is widely suspected to be due to an agenda that they are working towards.

    I agree with Evaporate - this is not anything to be pleased about and it is everything to oppose for all the same reasons that medical regs should be opposed.

    If this is how it starts off - it will be full blown medical regs by the time it has worked it's way down to national implementation.

  3. If anyone is in any doubt, read article 18 and ask yourself :

    Does look like consumer regs or first stage of pharma regs ?

  4. Posted as Rotax@UKV

    Take a closer look what the 'refill container' means. It is the same e-liquid in a bottele which has been tested with the device described in the section 2. So this directive will remove quite a lot e-liquids from the market since there is no rules to certify e-liquids only. So this is the way they will ban e-cigs. It is just hidden into the directive

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