UK regulation -- Discussion thread
This thread is for discussion of UK regulation, and comment on posts in the Reports and Updates thread (which is closed and just for the reports). Link:
Last edited by rolygate; 06-08-2010 at 05:42 PM.
Just thought I'd post a comment on the MHRA meeting report.
What this is all about is that a department of government is trying to classify ecigarettes as a medicine (an NRT). This means suppliers would need to apply for an MA, which is a pharmaceutical license. The cost of this, for various reasons, would range from an estimated minimum of £100,000 to a more realistic £350,000 (the licence cost is in the region of £30,000 but to get to the point of being able to apply for a licence costs many times more than that).
An ecigarette not covered by an MA would be deemed an unlicensed medicine. Anyone selling them in the UK would be prosecuted.
The obvious implication is that 99.9% of suppliers would go out of business immediately. The second result is that supply would then move offshore and continue exactly as before. As you may know, using 'unlicensed medicines' is not illegal so users could not be prosecuted. In addition, postal supplies of small, consumer-quantity unlicensed medicines are not prohibited (small packets are not intercepted or blocked - it is not illegal to use unlicensed medicines). Even if the regulations were adjusted in order to stop the resulting massive ecigarette postal influx, supply via other imports would continue - the only result would be that the price would go up. Customs & Excise have never succeeded in stopping the importation of products that consumers want, and they wouldn't succeed this time either. They failed with 'illegal radio transmitters' in the 70s and government was defeated on the issue, they are assured of failure this time round.
Therefore supply would continue as before although many things would be different. The first and most important thing is that there would then be no regulation or quality controls on ecigarettes. They are already under BIS (the new name for the DTI) and regulated by LACORS through the Trading Standards authorities. All UK brick and mortar ecigarette outlets, and all UK-based Internet outlets, are visited, inspected, and materials tested & analysed by TSA at present. If the business moves offshore, all such controls will disappear.
It bears repeating since some factions are trying to deny or obfuscate the fact: e-cigarettes in the UK are already regulated efficiently by Trading Standards authorities.
If business goes offshore all that ends. In addition, banning ecigs (as pharmaceutical classification is equivalent to) will create a massive fashion trend, since users cannot be prosecuted. Can you imagine how much that will amplify the profile of ecigarettes? Currently, hardly anyone in the UK has heard of them. Banning them will certainly fix that...
So there you go: MHRA action would remove all regulation and controls from UK ecigarette sales, create a monster fashion trend, fail to stop supply in any way, kill off hundreds of jobs, take a lot of tax revenue out of the system, and create an untenable situation for the government. Defeat is assured under those circumstances - we know this because it's happened before and the result is always the same: a painful and humiliating defeat for government. At least we would have the satisfaction of seeing a lot of the blame being attached to those responsible at the MHRA.
Our efforts must be concentrated on raising the profile of ecigs in the UK because at the moment, nobody has heard of them. In that sort of climate, assorted government departments can cowboy their way around the industry as they like, because there is no story in it. We have to change that.
Last edited by rolygate; 06-06-2010 at 01:25 PM.
Thanks Roly, I found the MHRA meeting report you posted on the reports thread very interesting.
This statement was a bit of an eye-opener to say the least! :-
" It was then revealed that there was in fact no requirement for an NRT to have any nicotine nor indeed any effect. MHRA stated clearly, openly, and repeatedly that it is not necessary for an NRT to supply any nicotine whatsoever, and that an NRT, even nicotine patches, could be - and indeed currently are - licensed by MHRA even if they do not supply any nicotine to the user, since this is neither measured nor is there any minimum or maximum standard for such devices nor is there any requirement for them to function in this way"
Thank you so much for posting this rolygate. The MHRA obviously have no idea what they are talking about and have not thought through the consequences of their actions.
I agree that part of their ignorance stems from the general public's lack of awareness of the products available and what they can offer the smoker.
The major UK vendors (most of whom can be found on ECF) should work together to get the message of e-cigs/PVs out there as an alternative to smoking. Let's promote the products that work, and advertise them in a realistic way to the smokers out there.
They should work together to counteract the other companies out there that mis-lead smokers into buying inferior products with false claims. Those companies do spend the money on advertising in the UKs papers, magazines, radio and in shopping malls and they cause more harm than good to the smokers who ditch their poor products after a few days and return to smoking tobacco.
Vaping should also be promoted to all the Pubs out there. Traditionally they were places where smokers would 'come into their own' - until the Smoking Ban in 2007.
Let's promote vaping. It is a legal activity, it is legal to do in public places and it is a lot healthier than the burning tobacco alternative.
Thank you rolygate
Yes... When repeatedly asked what the minimum or maximum nicotine levels in the blood are for NRTs (such as nicotine patches), as we wanted to know what we would need to comply with, the answer revealed why we hadn't been given any information of this sort: there is no specification or measurement. In other words, they don't need to work, they just need to be sold as such.
[facetious remark deleted]
On re-consideration I would like to amend this post.
When you think about it, it is not the job of a regulator to define how products work (or decide on whether they work or not). A regulator cannot become involved in exactly how a product works, or specifying the working mechanisms, because this simply isn't their job. If it were, they would need to specify exactly how all medicines work - and this is just not possible or even desirable.
It might be possible to specify how an aspirin pill works but there must be medicines where this isn't even known, never mind definable. Therefore the exact way a manufacturer's product works is not a job for the regulator, whose task is simply to see that it is acceptably safe, and that products that are not safe are excluded.
This is a more realistic aim and achievable; defining the working mechanisms of pharmaceuticals and then testing every single one on the market - regularly - is not.
My apologies for the previous facetious remark - which I did edit out.
Last edited by rolygate; 06-09-2010 at 12:22 PM.
Rusty, I'll just add that I think the major effort over the next few months needs to be one of raising public awareness - the number one obstacle against us, that I can see, is public ignorance of e-cigarettes and what their potential is.
I agree Joe, but we ALL need to work together, pool our resources and speak with a common tongue. I think that getting that agreement by interested parties would be an almost impossible task - unfortunately.
Large scale promotion will inevitably cost money as well - where will that come from?
Who will make the decisions of how to promote vaping to the general public?
I'm willing to do my little bit and so will many other people but it does need to be co-ordinated and orchestrated properly.
Last edited by Chrissie; 06-06-2010 at 09:04 PM.
Thankyou for the post Roly. Was at any point the so-called affect on Metabolism discussed?
I was pretty shocked reading some of that,to think that they told a Focus group that they weren't regulated!
Not sure if this means anything but Lacors have taken down the 30/3/2009 press release(though still available on cache).Possibly because of the fact they got their maths wrong.
(waves to Chrissie,i'm coming up to 12 months because of that ebay group x)
Last edited by ckc; 06-06-2010 at 09:52 PM.
Enjoy the Ride