I confess, I was surprised to get a reply from the MHRA so quickly. I think it's only fair to keep everyone in the loop on this, after all the topic affects millions.
First, the response from the DoH for the MHRA;
Our ref: DE00000951956 Dear Mr Summers, Thank you for your correspondence of 5 August about the Tobacco Products Directive (TPD). I have been asked to reply. I note your concerns about the implementation of Article 20 of the TPD. As you will know, the revised EU TPD was adopted in April 2014. It sets out the first regulatory framework for electronic cigarettes and refill liquid containing nicotine. From May 2016, the revised TPD will establish rules for the safety, quality, ingredients and presentation of these products. Electronic cigarettes will be subject to a dual approach to regulation. Electronic cigarettes licensed as medicines in the UK will be subject to the medicines regulatory regime, for which the Medicines and Healthcare products Regulatory Authority (MHRA) is responsible. Electronic cigarettes that are not licensed as medicines will be subject to general consumer product safety regulation, with additional safeguards relating to safety, quality, ingredients and presentation, as required by the TPD. Under the new regulations, products or liquids containing nicotine that make claims relating to health or smoking cessation cannot be marketed as consumer products and must be licensed as medicines. The Government considers that the MHRA is best placed to act as the competent authority for non-licensed electronic cigarettes. The MHRA has extensive experience in the licensing of medicines containing nicotine. An important aspect of its role will be to ensure a proportionate regulatory framework that is distinct from its function in relation to the licensing of medicines. The operation of this regulatory framework will be informed by engagement with stakeholders. The MHRA is an executive body of the Department of Health and it is subject to the same standards of transparency and impartiality as all government departments. I hope this reply is helpful.
Yours sincerely, David Segar Ministerial Correspondence and Public Enquiries Department of Health
This, sadly, reads very much as if they've missed the point by miles.
Thank you for your reply.
The TPD does not establish rules that will ensure safety, quality, ingredients or presentation for electronic cigarettes. What it does is set limitations on the quality and efficacy of electronic cigarettes whilst destroying any ability or drive to advocate, promote or improve them. It also pushes the devices into the clutches of the Tobacco/Pharmaceutical companies who would be among the only businesses sized to cope with the costs imposed by the TPD Article 20 amendments.
A point of clarity: Electronic cigarettes are already subject to general consumer product safety regulations. The TPD Art 20 amendments go far beyond those of general product regulations.
Another point of clarity: Vaping (electronic cigarette is such a loaded name and so passé) does not involve combustion, therefore by its nature is automatically a smoking cessation product if used to switch. The TPD is unclear and ambiguous on this, when actually the meaning would apply to a “nicotine cessation” product. This is a point of concern, as this makes the amendment unfair.
The government may consider the MHRA to be best placed to act as a competent authority, however I categorically disagree. The MHRA has no expertise whatsoever in the field of complex consumer devices especially this product, only as you have said in nicotine containing medicines. Surely any such planning should involve at least experts in the devices and their application, people such as Dr Konstantinos Farsalinos or organisations such as ECITA or the New Nicotine Alliance?
As separate products, medicinal and consumer, it does not sit well that both will be effectively regulated by the same body.
The annex describing the portal is disjointed from the reality of the user experience or expectations for the product, and only serves to assist the imposition of overheads on manufacturers large and small. This layer of difficulty is disproportionate when compared to say alcohol or caffeine products.
I would also argue that the MHRA should not, from the grounds of impartiality and transparency, be involved in anything that is not directly a medical product. I forgo discussing allegations that have been made publicly and in parliament around the lack of true impartiality within the MHRA.
I hope this helps and clarifies my position somewhat.
And I think that's really the message. The process is wrong, the definitions are wrong. Hell, the whole thing's wrong top to bottom because it's outmoded, based on invalid reports and evidence, biased towards big industry.
But worst of all, it's been crowbarred into a TOBACCO policy!
My advice remains, write to your MP & MEPs, support the Article 20 legal challenge and sign Dave Dorns petition at change.org here.