MHRA confirms e-cigarettes are not medicinal products – but they still face ban

| September 9, 2013 | 0 Comments

TotallyWickedE-cigarettes manufacturer 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.

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.

Totally Wicked Chief Executive Officer Fraser Cropper 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.”


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