Chrissie - Roly, there is also the other side of the coin if I'm reading the statement right. If they have no idea of the maximum amount of nicotine the patches deliver, how can the MHRA license them as safe products?
There is no specification for NRTs' real-world performance - no standard for efficacy (minimum nicotine level) or toxicity (maximum nicotine level). However, clinical trials must show them to be safe*, which is one of the main reasons for the trials. The mechanics of how they actually work are not measured. A clinical trial would not need to prove they work, just that they are safe (a clinical trial of NRTs would not be able to show that they 'work' in any case, as that can only be measured by long-term success in quitting smoking, if that is the designed objective).
* This is defined where medicines are concerned as 'acceptably safe', which is a realistic way of looking at things, since there is no such thing as absolutely safe.
As far as I am concerned, criticism of whether NRTs work or not is a matter for another arena, it doesn't really concern us. We simply wanted to know what we had to measure up to - which turns out to be: actually, nothing.
In addition, since ecigarettes are not an NRT and are not sold as an NRT, and are not designed to treat a disease or sold for that purpose, in the end this is not a concern for us. It's just that while we were there, we thought we'd try and get some tech specs, but as stated, there are none. The basis of NRT classification seems mainly to be on the marketing claims, and apparently it's OK to market a device as an NRT if it may or may not operate efficiently. Our main concern, actually, is that if a device - specifically, an ecigarette - is not marketed as an NRT, does that exclude it from NRT classification? This is still a point of debate. There are several nicotine-containing products that are not licensed by MHRA since those products do not make any health claims in their marketing.
This is the main reason it is
imperative that ecigarette suppliers do not make any health claims. As soon as you make some sort of health claims, you come under the remit of MHRA and you
really don't want to be there...
Any product that makes substantive health claims, in the UK, needs a pharmaceutical licence. This is a broad statement that is not entirely true in all cases, but is the basic guide. A pharmaceutical license, aka an MA (marketing authorisation), costs hundreds of thousands of pounds - for each product. The license cost is £28,000 but getting there costs a whole lot more. In effect it would put 99.9% of suppliers out of business. You can't operate in the UK if your products are classed as illegal medicines, and that would certainly apply to all forms of eliquid that contained nicotine. Other eliquids are a grey area, they are inhaled but might be seen as exempt (ie zero-nic liquids). The hardware is another matter and at this point an unknown quantity. However, it will be impossible at some stage to sell ecigs of any kind (including mods) without a CE mark. To a certain extent, that issue is separate from the MHRA one - it's probably a LACORS / Trading Standards issue.
CKC - Was at any point the so-called affect on Metabolism discussed?
In a roundabout way; Katherine Devlin took the minutes for the trade side and I think she noted some instances. I could include those but the end result of discussion was of no consequence - from a practical point of view, MHRA does not really address this since they don't have any specifications or measurements for doing so. They would not be interested in measuring ecig levels or whatever because they have no mechanism for doing so.
I have been a little critical of their technical knowledge and procedures (being an engineer) but, in truth, they are a government body concerned with broad licensing issues and not specifics. I believe they act correctly given their remit. If something is dangerous, they need to know, but apart from that - how things work, or if they work, is not really their concern I suppose. And also we should consider that many of their customers are mega-million pharmaceutical companies and those people don't want to get involved with how their products work.
By the way, it needs to be said that Katherine Devlin (FreeGenieEcigs), who was agreed as our legal / technical legislative advisor / spokesperson, did a superb job. She was extremely well prepared and has done a first-class job of steering us in the right direction. We are lucky to have her on board.
Rusty - Large scale promotion will inevitably cost money as well - where will that come from?
ECF will provide fundraising resources for a UK trade association and/or publicity - US or UK of course. We are very keen to get started on this but up to now, the projects we've been approached with weren't good value for money; they tend to be for 'general' fundraising, or for research projects that are extremely expensive and don't look good value.
What we want to see is
specific projects so that people know
exactly what the money is for. The project needs to be precisely targeted and good value for money. When this sort of project is presented, we'll go for it. We don't want to be associated with anything that fails badly, and that is also a key consideration. As yet we haven't done anything like this on a large scale so it is a little intimidating to be asked to fundraise for a research project @ $80,000 since there is a possibility of failure. A project that comes in under $10k looks far more promising, and maybe even $25k is achievable. It may well be that a lot more is achievable but we don't want to start out by trying to raise £100k...
.