Doodlebug
Postman
- Joined
- Sep 6, 2012
- Messages
- 126
Last week, there was much discussion across the vaping community and well beyond about the reported ‘leaked’ draft of the European Commission’s revisions to the Tobacco Products Directive. For anyone who missed it, it started with this article in the Tobacco Journal International. Oh, but don’t get excited. It’s behind a paywall, so you can’t read it unless you subscribe.
Our colleague James Dunworth, of Ashtray Blog fame (notoriety?
), went to the extent of subscribing, but apparently has not been able to read the article even then.
The ‘leak’ appeared in the German press, which was followed by Chris Snowdon’s blog (amongst other reportings), and then Professor Michael Siegel appeared to confirm that the ‘leak’ was genuine.
I don’t know whether the reported leak is actually representative of the European Commission’s position or not. Frankly, it seems a little unlikely, since it would take them several (long!) steps away from the scope of the Impact Assessment portion of their consultation process, which is the stage they are currently concluding. So in an effort to track down something a little more factual than assorted reports – however credible – of a leak, I wrote to the Commission last week, as follows:
21st September 2012
Dear Dr Seychell,
Re: Revisions to the Tobacco Products Directive
It is with great alarm that we read reports of a ‘leak’ of your proposed revisions to the Tobacco Products Directive. It is being reported that the revised Directive will recommend a ban on all nicotine containing products unless ‘captured’ by tobacco regulations or medicinal regulations. It is reported that this will include electronic cigarettes.
I have explained before, but will reiterate again, that electronic cigarettes are not tobacco products, nor are they medicinal products. They have not been introduced to market by either the Tobacco Industry or the Pharmaceutical Industry, although both of these industries have been ‘buying in’ to the electronic cigarette industry.
Before leaving that point, it is necessary to stress once again that this need not change the product classification. The products from the electronic cigarette industry – whether brought to market by individual businesses from within that industry, or any other – are consumer products, robustly and well covered by existing consumer product regulations, full details of which we have already submitted for the Commission’s consideration.
It has been suggested that the Commission will recommend that electronic cigarette products should not be classified as tobacco products (a position we have already agreed with), but should be classified as medicinal products, and removed from the market until such time as they have a Marketing Authorisation from the relevant medicines regulator in each Member State.
Clearly, this would not be an appropriate suggestion (or Heaven forbid, Directive) from the Commission within the scope of the revisions to the Tobacco Products Directive, since it would need an entirely new consultation from the Commission to assess the question of whether or not electronic cigarettes should be classified as medicinal products.
Indeed, this question has been the subject of intense debate since electronic cigarettes first appeared in the global market in 2006/7. On several occasions now, this has been tested in various courts, and on every occasion, the rulings have indicated that the various legal definitions of a medicinal product in the different territories’ do not support the classification of electronic cigarettes as medicinal products, unless claims are made by the marketers that are deemed to be medicinal claims, such as ‘use this product to quit smoking’ and the like. (Indeed, when we met with the Commission, you agreed with us on this point.)
We stand ready to take the MHRA to court next Spring if they continue to try to misclassify electronic cigarettes as medicinal products, and we have every confidence that this would be successful. (We are working with other areas of the UK government, who seem to have a better understanding of the realities of this issue, and sincerely hope that Court action can be avoided.)
As we understand it, the Commission will now have completed the Impact Assessment for this consultation process. This will, no doubt, have indicated the significant economic growth of the electronic cigarette industry, and your own Eurobarometer survey clearly demonstrates how significant the positive impact on public health could be, if electronic cigarettes remain widely available to smokers. Equally, it is increasingly apparent that the risk of an explosive black market in electronic cigarette sales would be inevitable if their availability were to be restricted, which could only be utterly dangerous for the public. It is absolutely crucial that the proper regulatory standards are in place, but this cannot be achieved through medicinal regulation. The costs are too high, and the restrictions on the flexibility and appeal of the product are too great, so all the considerable public health benefit potential would be lost.
Yet there are so many millions of citizens who have successfully made the switch to using electronic cigarettes rather than smoking, and many of these citizens will want to continue to use these products even if they are illegal. Our concern in this regard is that this would remove the current quality and safety standards which are in place by virtue of the GPSR et al. These standards are essential in order to maximise the public health benefits. We do not want vapers to be forced into using potentially dangerous, unregulated products, of dubious origin.
Whilst we remain confident that the intentions of the Commission are genuinely concerned with achieving good public health outcomes, we would appreciate some assurance from you that the reported ‘leaked’ document has indeed been misrepresented. As more and more genuine research is carried out into the safety profile of electronic cigarettes (properly regulated under the GPSR et al), the more it becomes apparent that these products have the potential to dramatically influence public health outcomes positively.
It is our intention to publish this letter on our blog after 7 days have elapsed, unless there is a good reason for not doing so. This is so that the vaping community can be kept informed as to what ECITA is doing, since the reported ‘rumours’ and ‘leaks’ have been causing some distress, as I’m sure you can imagine.
I look forward to hearing from you at your earliest convenience.
Yours sincerely,
Katherine Devlin
President
ECITA (EU) Ltd
cc Dominik Schnichels
I am yet to receive a response, but will keep you informed if/when I do.
More...
Our colleague James Dunworth, of Ashtray Blog fame (notoriety?
The ‘leak’ appeared in the German press, which was followed by Chris Snowdon’s blog (amongst other reportings), and then Professor Michael Siegel appeared to confirm that the ‘leak’ was genuine.
I don’t know whether the reported leak is actually representative of the European Commission’s position or not. Frankly, it seems a little unlikely, since it would take them several (long!) steps away from the scope of the Impact Assessment portion of their consultation process, which is the stage they are currently concluding. So in an effort to track down something a little more factual than assorted reports – however credible – of a leak, I wrote to the Commission last week, as follows:
21st September 2012
Dear Dr Seychell,
Re: Revisions to the Tobacco Products Directive
It is with great alarm that we read reports of a ‘leak’ of your proposed revisions to the Tobacco Products Directive. It is being reported that the revised Directive will recommend a ban on all nicotine containing products unless ‘captured’ by tobacco regulations or medicinal regulations. It is reported that this will include electronic cigarettes.
I have explained before, but will reiterate again, that electronic cigarettes are not tobacco products, nor are they medicinal products. They have not been introduced to market by either the Tobacco Industry or the Pharmaceutical Industry, although both of these industries have been ‘buying in’ to the electronic cigarette industry.
Before leaving that point, it is necessary to stress once again that this need not change the product classification. The products from the electronic cigarette industry – whether brought to market by individual businesses from within that industry, or any other – are consumer products, robustly and well covered by existing consumer product regulations, full details of which we have already submitted for the Commission’s consideration.
It has been suggested that the Commission will recommend that electronic cigarette products should not be classified as tobacco products (a position we have already agreed with), but should be classified as medicinal products, and removed from the market until such time as they have a Marketing Authorisation from the relevant medicines regulator in each Member State.
Clearly, this would not be an appropriate suggestion (or Heaven forbid, Directive) from the Commission within the scope of the revisions to the Tobacco Products Directive, since it would need an entirely new consultation from the Commission to assess the question of whether or not electronic cigarettes should be classified as medicinal products.
Indeed, this question has been the subject of intense debate since electronic cigarettes first appeared in the global market in 2006/7. On several occasions now, this has been tested in various courts, and on every occasion, the rulings have indicated that the various legal definitions of a medicinal product in the different territories’ do not support the classification of electronic cigarettes as medicinal products, unless claims are made by the marketers that are deemed to be medicinal claims, such as ‘use this product to quit smoking’ and the like. (Indeed, when we met with the Commission, you agreed with us on this point.)
We stand ready to take the MHRA to court next Spring if they continue to try to misclassify electronic cigarettes as medicinal products, and we have every confidence that this would be successful. (We are working with other areas of the UK government, who seem to have a better understanding of the realities of this issue, and sincerely hope that Court action can be avoided.)
As we understand it, the Commission will now have completed the Impact Assessment for this consultation process. This will, no doubt, have indicated the significant economic growth of the electronic cigarette industry, and your own Eurobarometer survey clearly demonstrates how significant the positive impact on public health could be, if electronic cigarettes remain widely available to smokers. Equally, it is increasingly apparent that the risk of an explosive black market in electronic cigarette sales would be inevitable if their availability were to be restricted, which could only be utterly dangerous for the public. It is absolutely crucial that the proper regulatory standards are in place, but this cannot be achieved through medicinal regulation. The costs are too high, and the restrictions on the flexibility and appeal of the product are too great, so all the considerable public health benefit potential would be lost.
Yet there are so many millions of citizens who have successfully made the switch to using electronic cigarettes rather than smoking, and many of these citizens will want to continue to use these products even if they are illegal. Our concern in this regard is that this would remove the current quality and safety standards which are in place by virtue of the GPSR et al. These standards are essential in order to maximise the public health benefits. We do not want vapers to be forced into using potentially dangerous, unregulated products, of dubious origin.
Whilst we remain confident that the intentions of the Commission are genuinely concerned with achieving good public health outcomes, we would appreciate some assurance from you that the reported ‘leaked’ document has indeed been misrepresented. As more and more genuine research is carried out into the safety profile of electronic cigarettes (properly regulated under the GPSR et al), the more it becomes apparent that these products have the potential to dramatically influence public health outcomes positively.
It is our intention to publish this letter on our blog after 7 days have elapsed, unless there is a good reason for not doing so. This is so that the vaping community can be kept informed as to what ECITA is doing, since the reported ‘rumours’ and ‘leaks’ have been causing some distress, as I’m sure you can imagine.
I look forward to hearing from you at your earliest convenience.
Yours sincerely,
Katherine Devlin
President
ECITA (EU) Ltd
cc Dominik Schnichels
I am yet to receive a response, but will keep you informed if/when I do.
More...
