EU UK regulation -- Discussion thread

[rolygate]

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:

http://www.e-cigarette-forum.com/forum/e-cigarette-news/97220-uk-regulation-reports-updates.html




.

 

[rolygate]

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.

 

[Chrissie]

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! :-

" [FONT="]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"[/FONT]

 

[Rusty]

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.

Russell

 

[Dave_uk]

Thank you rolygate

Great report.

 

[rolygate]

@Chrissie
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]

[edit]
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.


.

 

[Oliver]

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.

 

[Rusty]

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.

 

[Chrissie]

@Chrissie
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.

It's the UK government folks, if you didn't think 'Yes, Minister' could possibly be true to life - you were wrong.

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?

Joe, I also agree & like Rusty, I'm trying to do (& have been doing so since buying my first e-cig in July 2008) to let as many people as possible know about the e-cig. I sadly lost a large audience due to eBay's ban on sales & any mention of e-cigs As well as my now defunct eBay e-cig group, I used to post about e-cigs on several of their community forums. Still risk it occasionally

 

[ckc]

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)

 

[rhoobarb]

great post as rusty said i think we all could do are bit just need working together and a plan i added a group on my facebook trying to get more people aware of ecigs wil the ban be the eliquid containing nicotine or ever think

 

[Mister]

Great report, thanks rolygate!

I'm impressed by the way the UK trade and community reps came together on this. Together you presented knowledge and a force to be reckoned with. Now we must hope that the MHRA will understand the reasoning and the consequences if they pursue this, and decide they'd do better spending their time elsewhere.

 

[rolygate]

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...

.

 

[rolygate]

Again, it needs to be emphasised that our main direction should be to avoid any and all connection with MHRA. This is because (a) ecigarettes are a general consumer product and not a medicine; and (b) if they are classified as a medicine, the industry as we know it would be shut down since medical licensing would apply.

Even if the MHRA prevail, there is some light at the end of the tunnel since in the long term, government is certain to be defeated on this issue - it always has been in the past and this time round it is even more likely. However, that process takes years of course, and during that time the entire business moves offshore.

It is vital that ecigarette suppliers do not make any kind of health claims, in order to strengthen our position. Those that do are simply cutting their own throats - and ours as well.

 

[rolygate]

CKC - 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.

Yes, that's interesting. They leave themselves open to civil action if they leave it up, though, because it is entirely wrong and defamatory. Luckily for them there is no working trade association at the moment.

It seems incredible that a government agency could make a mistake on this scale but truth is stranger than fiction. They claimed that a sample of 18mg / 1.8% nicotine strength eliquid was actually of 180mg / 18%, and also repeated that samples were of about 20% nicotine strength.

1. Samples would need to be sent to a laboratory for analysis - but that cannot be the case since no chemist would make a factor-10 error when analysing a sample. They are asking us to believe that a qualified chemist, who does this every day for a living, can make errors on this scale. This is not just unlikely, it is ridiculous.

What is far more likely is that an office junior was tasked with investigating the samples and simply read the ingredients off the pack. Being a school leaver or similar, they then misinterpreted the information, not knowing or understanding systems of defining chemical constituents. This resulted in them assuming the contents were of 20% nicotine, which is a dangerous level.

I have to assume it was an office junior or school leaver who made the error, it is frightening to imagine a regular or senior member of staff being so ignorant.

2. Having made one serious error they then compounded it by making another, possibly worse one: they immediately published the results without checking them. You would think that if an office junior detects dangerous substances on the high street then at least a senior staffer would need to check the issue.

3. They then refused to reply to communications on the issue, and instead of taking the wrong information down while checks were made, it was left online for an extended period of time.

I expect that there is a good case for damages there especially since this synchronised quite nicely with the MHRA's interest. [conspiracy theorists start here ] Luckily for them, there is no trade association that wants to take this up right now. That might change fairly soon though.

Here is a quote, on the page in question, from their Chair:
Councillor Geoffrey Theobald OBE, LACORS Chairman said,

“Councils are testing as many of these electronic cigarettes as possible and protecting people by dealing with the issues relating to incorrect packaging and labelling.

Wrong. The packaging and labelling is correct for their content. If, as your 'technicians' have asserted, it was as strong as rat poison, then you would be right.

“It is disturbing that while banned in Australia, these products are on sale here in the UK without a warning to people about the high nicotine content and the danger they present to children.

Lots of things are banned in Australia, such as websites that expose government corruption and incompetence. This site would most likely be banned in Australia, for publishing this post. And also your facts are about as accurate as government spending predictions...

“It is totally unacceptable that as things stand, children are able to legally purchase electronic cigarettes exposing them to high concentrations of nicotine.

Unfortunately not the case. Hire someone who knows what they are talking about and/or stop giving important tasks to school leavers.

“The government needs to introduce new laws that force manufacturers to restrict the sales to people over 18 years of age.”

I would agree that super-strength rat poison should only be sold to adults. Actually, not even to some adults, probably. But as all your facts are wrong it's a moot point.

--------
The poor man sounds as if he is apoplectic. He should be - mainly because of his staff's incompetence. Oh well - you just can't get the staff these days...


.

 

[freakindahouse]

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.

Hi, all,

It's enormously gratifying to know that my exposure of LACORS' inability to understand the rather crucial importance of the decimal point has finally resulted in some action! (Naturally, a public grovelling apology would have been better, but we can't have everything.)

Rolygate, congratulations on a frankly astonishingly accurate representation of Friday's meeting, from memory. Impressive application of the grey cells! Thank you for your kind words about me - unnecessary, but always gratefully received.

Many of us from the industry were disappointed to see the TOTAL lack of information about ecigs displayed so openly by the MHRA. It doesn't seem that it would be too much to expect for them to have at least googled the subject to gain a little insight into the products they have chosen to target, and indeed about the industry they are threatening. It wouldn't have been hard to find out all that they needed to know to assure them that these products fall squarely outside their remit to regulate, since these are not medicines. (Sorry, intellicig, but they're not!)

I have no criticism to offer of Rolygate's most excellent analysis and reporting, but I would just like to (hopefully succinctly!) clarify the difference between Harm Reduction and Harm Management. Very simply, Harm Reduction is about freedom of choice for autonomous individuals to choose safer/healthier ways to do things, i.e. seatbelts, parachutes, and indeed decaff coffee and low/non-alcoholic beers, and crucially, has NOTHING to do with medicines. Harm Management, on the other hand, is a 'control tool', whereby products designed to mitigate harm are appropriated by the Pharmaceutical Industry (and/or its regulators) to remove individual autonomy, and effectively force harm reduction upon people.

The key difference concerns autonomy, individual freedom and personal choice, Harm Reduction offering all three, and Harm Management offering none. As a responsible adult (usually!) I know which I would prefer. Others may make up their own minds... for as long as they are allowed to, that is.

Just for the record, the funniest moment of the whole MHRA meeting, IMHO, was when Jeremy Mean - when asked what nicotine actually treats - stated (quite brazenly) that nicotine treats tobacco addiction. What risible nonsense!

FYI, I have been on the phone this morning to June Raine's secretary, who persisted in referring to Friday's meeting as "The NRT Meeting". She refused to be corrected on this point, and repeated it several times. Perhaps this gives us further insight into the MHRA's thinking on this whole issue. This seems a sad indictment on our government's regulatory body, and is something that they cannot and must not be allowed to get away with.

Getting our industry together to fight the good fight as a unified body is absolutely essential if we are to make headway against these wombats. The alternative really doesn't bear contemplation.

Happy vaping one and all - and long may it continue!

Katherine

 

[freakindahouse]

1. Samples would need to be sent to a laboratory for analysis - but that cannot be the case since no chemist would make a factor-10 error when analysing a sample. They are asking us to believe that a qualified chemist, who does this every day for a living, can make errors on this scale. This is not just unlikely, it is ridiculous.

What is far more likely is that an office junior was tasked with investigating the samples and simply read the ingredients off the pack. Being a school leaver or similar, they then misinterpreted the information, not knowing or understanding systems of defining chemical constituents. This resulted in them assuming the contents were of 20% nicotine, which is a dangerous level.

I have to assume it was an office junior or school leaver who made the error, it is frightening to imagine a regular or senior member of staff being so ignorant.

.

Be afraid, be very afraid! I have seen the lab report, and it was indeed a lab which got it wrong. LACORS' error, as you rightly point out, was not to check this. Indeed their own wording in the press release was incorrect mathematically anyway, unless our industry were only producing ecigs fit for Action Man, since the cartridges would need to have contained a mere 0.1ml of eliquid, which would be a minuscule cartridge.

Ignorance is bliss - and these guys certainly seem blissfully ignorant! (Oddly reminiscent of the MHRA's knowledge base on the subject!)

Katherine

 

[Chrissie]

Katherine, Roly & all, thank you so much for all the information.

I'm not the brightest of sparks, so although I do understand what you are all saying, I'm finding it difficult to focus & respond with anything remotely helpful.

I fully understand the important message going out to suppliers but what is, in your opinions, the best action that individual vapers (like myself) should take to make the biggest impact to help fight the cause?

Once again, thank you so much to Katherine in particular.

 

[freakindahouse]

Awwww, shucks! You're gonna make me blush! LOL

I can't speak for everyone, obviously, but IMHO, the very best thing the vapers can do is to keep right on vaping! (Unless, of course, you have access to the front page of any or all of the main newspapers? LOL)

Take care, honey,

Katherine

 

[Chrissie]

LOL Katherine, I so wish I did have front page access to the main newspapers

At the moment, I'm concerned at how little response there is from other UK vapers to this thread (present company excepted )