NHS e mail and my reply

[Deleted]

got to agree with hi fi on this one
you cant buy patches tablets or any other nrt's from any where except chemist's if you did you cant be sure of whats in them
and the same will be for cartos and ecigs unless you met a guy in a long mac saying ere mate wanna buy some ejuice
It happened with viagra and fake vodka and has some dire consequences
better we use and promote within rather than have it classified and restricted
for those it may benefit (the poor etc ) will find a way around giving up buy sticking with their black market suppliers
at least those of us that are a litlle informed can produce our own mods atties and juice if you can get hold of a legit source of nicotine mix, but most (me included) wont know therefore will continue with their habit and be none the wiser to a wonderful experience as vaping

[hifistud]

Apr 14, 2012 21:11:34 GMT Karma said:

Hifi, you seem to be very well informed about the situation. What is your contingency plan?

I already use pretty much exclusively Dekang juices in RY4, RY Hi5 and RY6 - so 10KG of each would be bought in and placed in the freezer, with regular stock-ups from sources abroad, were it needed. 3 litres does me a year, so that's ten years worth. Kantal wire and wick are no problem to source, and I'll be stocked up on rebuildables enough to manage.

But, you see, I'd much rather not have a contingency plan, or the need for one. In truth, I think the Intellicig MA is pretty much a done deal, and the same applies to the Nicoventures one, but I'm really, really hoping that Katherine Devlin and ECITA can work some magic in Europe to achieve a third way classification for e-cigs.

With that said, though, if Intellicig and Nicoventures are both successful in the time scales I'm aware of, then, basically, we're screwed. The MAs will be granted ahead of the consultation re-opening, by the looks of it, at which point any counter-arguments we as a group put forward can be countered right back at us - "you've got Intellicig and Nicoventures products to use, and in a year or two's time, there may be more" will be the reply. Until then, close the vendors down.

I think we may well be discussing this on VT Talk on Wednesday. All is not yet lost, although it's not looking good.

[Karma]

I would prefer not to have a contingency plan either

There have been similar threads before in my short time here and I always wonder why none of the vendors ever post in them?
I like vaping, it keeps me off the ciggies and I don't want government intervention. Our hard working, very helpful vendors could lose their business.

I would like to hear the vendor's views on this ?

[Queenie Bee]

Will be tuning hifi last weeks with the tv clips was informative but this will be a must watch for me I think the vaping community really needs clarification on this subject especially us newbies and further more what we can do and also what we will need to stock up on if the worst happens !
Karma really interesting point on the vendors I too would be interested on their opinion

[maccafan]

Apr 14, 2012 21:05:22 GMT hifistud said:

Read MLX 364 of the MHRA. Their preferred action is to license nicotine containing products and remove any unlicensed nicotine products from sale within 21 days.

I read that thanks to Chrissie's link. They are considering other options too and not just saying option1 is what they will do. They state that option 1 is their preferred option.

The law already states that only products with an MA from MHRA can be sold as medicinal use products. Without one, anything purporting to be a medicine (your "unofficial NRT") or generally understood to be medicinal (which is exactly how you describe e-cigs - "unofficial NRT") must not be sold, and must be removed from sale until it has achieved an MA - at a cost, I have to say, of hundreds of thousands of pounds.

Exactly my point. Who says that currently available e-juice is flogged as medicinal and can't be allowed to continue? That's what I meant by regulatory framework. If it comes to that I cannot see the Chinese manufacturers just stand by with millions invested in equipment and facilities and not get an approval.

The MHRA can refuse an MA at its own whim - it sets the standard, and, given what we know of Intellicig's route-map, and the fact that they deal with the MHRA every day, and have adopted a pharma-friendly packaging for the only "refills" that will be allowed, you can guarantee that e-juice will not be allowed an MA - and even Intellicig will not push for it, because prefilled carts are much more profitable for them.

I doubt that MHRA is going to ignore a product that's as successful as e-cigs to stop people smoking tobacco. It's also naive to even think that they are not going to seek to regulate it. Big business is going to look for opportunities to do what they have to do which is to make money.

Minority?? Hardly. All of the research that's been conducted says that folks switch because they don't want to quit.

And the market won't change - it will cease to exist.

What research..Pray tell? How many non-smokers have you seen who take up vaping because it's a recreational activity?

If the worst happens and the market disappears, it goes. I don't see any need to wind myself up about it. I'll just find ways around it and move on. I somehow don't see it happening and I am really tired of repeating myself..It cannot be practically enforced as products in e-juice cannot be banned except the sale of nicotine itself. So you think ecopure are going to stop the sale of their own product which they have been selling for some time now.I don't think so.

[hifistud]

Apr 14, 2012 22:02:43 GMT maccafan said:

I read that thanks to Chrissie's link. They are considering other options too and not just saying option1 is what they will do. They state that option 1 is their preferred option.

Are you aware of the history of MLX 364? Do you understand the criteria that the MHRA can and will press ion use in order to structure the market the way they want it? Read on...

Exactly my point. Who says that currently available e-juice is flogged as medicinal and can't be allowed to continue? That's what I meant by regulatory framework. If it comes to that I cannot see the Chinese manufacturers just stand by with millions invested in equipment and facilities and not get an approval.

Again, you miss the point. If e-cigs are medicinal, then every e-cig product is medicinal - and that perforce includes e-liquid whether nic-containing or not. The MHRA has strict rules about dosage and packaging - let me give you an example: Unless you are licensed as a dispensing chemist, you can only buy aspirin in packs of a low number. Same applies to paracetamol and a number of other potentially poisonous medicines. They are sold only in sub-lethal dose packages. Since 2ml of 45mg juice (the juice used in the new Intellicig 15mg carts) exceeds the LD50 by 50% , it will not be granted an MA - it's pre-filled carts or nothing.

Further, even if the MHRA is minded to allow an application for juice, each strength, flavour and diluent variety must have a separate MA - and an MA costs well in excess of £200,000 per product.

I doubt that MHRA is going to ignore a product that's as successful as e-cigs to stop people smoking tobacco. It's also naive to even think that they are not going to seek to regulate it. Big business is going to look for opportunities to do what they have to do which is to make money.

The MHRA is funded by... Big Pharma. So, your statements are correct - they're not ignoring e-cigs - they want them gone in their current market and under MHRA control as medicines - Option 1 - their preferred option. But they don't just take them in and grant licenses wholly-nilly - no - they ban the whole lot and make the industry seek MAs on them. China is not likely to seek UK MAs on juice - it's a small part of the market for them, and the MHRA, as I have said, is most unlikely to include e-juice in their licensing strategy.

What research..Pray tell? How many non-smokers have you seen who take up vaping because it's a recreational activity?

Research conducted on ECF and other forums long before you signed up here to establish why folks tok up e-cigs. Research conducted by a Swiss university, and done globally, to determine exactly the same thing.

If the worst happens and the market disappears, it goes. I don't see any need to wind myself up about it. I'll just find ways around it and move on. I somehow don't see it happening and I am really tired of repeating myself..It cannot be practically enforced as products in e-juice cannot be banned except the sale of nicotine itself. So you think ecopure are going to stop the sale of their own product which they have been selling for some time now.I don't think so.

Again, you obviously do not understand how the MHRA works. It simply brands all e-juice and e-cigs as medicinal devices/products and requires that they have an MA before they're sold, takes down all non MA carrying product within 21 days, and that's it. It's that simple - if they so decided, they could do it tomorrow.

As for Intellicig, who make Ecopure, they'll still be selling ecopure - in 0.3ml cartridges, packed five to a blister card at £5 a card into the NRT market and laughing all the way to the bank while all the other vendors go bust or group together to try to take it all to court. In terms of bottles of juice, they will have no choice - they'll be stopped.

[maccafan]

Apr 14, 2012 23:36:44 GMT hifistud said:

Are you aware of the history of MLX 364? Do you understand the criteria that the MHRA can and will press ion use in order to structure the market the way they want it? Read on...

I haven't been involved with the vaping community very long but I do know that they tried to impose a ban on the grounds that it was an untested product with a potential to be dangerous a few years ago and then abandoned it. This consultation was reopened again about 18 months ago as far as I understand it.

What I do know is it is the very same MHRA that provides me with a level of reassurance that dangerous drugs do not get sold on the market and OTC medicines are relatively safe to take even if they err on the side of caution. That's the way a responsible regulatory body should work and nothing you or I do will change that. I am also aware that it is not a one man show and is accountable for it's actions at the highest levels of Govt. I don't think they act on a whim. If that were the case there would be no need for a consultation.

Again, you miss the point. If e-cigs are medicinal, then every e-cig product is medicinal - and that perforce includes e-liquid whether nic-containing or not.

I don't think I miss the point and think you are being presumptuous. I am reasonably aware of how the system works and what a regulation means.

My point is if e-cigs and e-juice is declared medicinal it will benefit a hell of a lot more smokers than it is currently doing where the word is spread by word of mouth and a lot of people haven't even heard about it despite being "popular" for 4 years now. So we can't be selfish just to keep our precious juice intact.

The MHRA has strict rules about dosage and packaging - let me give you an example: Unless you are licensed as a dispensing chemist, you can only buy aspirin in packs of a low number. Same applies to paracetamol and a number of other potentially poisonous medicines. They are sold only in sub-lethal dose packages. Since 2ml of 45mg juice (the juice used in the new Intellicig 15mg carts) exceeds the LD50 by 50% , it will not be granted an MA - it's pre-filled carts or nothing.

True. By the same coin batteries, PG, VG, water and food flavourings cannot be regulated by the MHRA. If someone chooses to pour water down his nostrils and drown himself that's his or her choice and MHRA will have no say in it.

No one can stop selling aforesaid products or a mix of aforesaid products by a different name and leave it to end users to obtain their own nicotine. MHRA is only seeking to only regulate those products that contain nicotine.

Further, even if the MHRA is minded to allow an application for juice, each strength, flavour and diluent variety must have a separate MA - and an MA costs well in excess of £200,000 per product.

I am not too sure on that so I'll take that statement on face value.

The MHRA is funded by... Big Pharma. So, your statements
are correct - they're not ignoring e-cigs - they want them gone in their current market and under MHRA control as medicines - Option 1 - their preferred option. But they don't just take them in and grant licenses wholly-nilly - no - they ban the whole lot and make the industry seek MAs on them.

MHRA is a regulatory body and exists to regulate products that exist in the market. So I don't see any reason why they would promote monopoly and not consider applications for similar products from other manufacturers. I don't think it is a dark conspiracy. The tobacco big boys had the foresight and the acumen to get in there first, that's all. They play for big money and that always attracts resentment.

China is not likely to seek UK MAs on juice - it's a small part of the market for them, and the MHRA, as I have said, is most unlikely to include e-juice in their licensing strategy.

Chinese business ain't blind or stupid. If they think they can double or treble their business by having a medically approved product, they'll jump in with both feet. If they see that their products are in danger of being declared illegal in big markets in Europe and US they will apply for approvals to protect their investment. A lot of the big Chinese e-juice manufacturers already have some amount of medical certification. You are right that the current UK market is small but if it is offered as a medical product at a cheaper price, the NHS and the Govt. will only be too keen to get that in the system. The Chinese business lobby is not without it's own political clout. We'll just have to agree to disagree.

Research conducted on ECF and other forums long before you signed up here to establish why folks tok up e-cigs. Research conducted by a Swiss university, and done globally, to determine exactly the same thing.

Have you got any links please to this research? The findings of this research presumably indicates that majority of people take up e-cigs as a recreation I take it.

Well I for one didn't. I took it up as a healthier alternative to smoking and I will speak for myself.

Again, you obviously do not understand how the MHRA works.

I find that presumptuous and arrogant.

It simply brands all e-juice and e-cigs as medicinal devices/products and requires that they have an MA before they're sold, takes down all non MA carrying product within 21 days, and that's it. It's that simple - if they so decided, they could do it tomorrow.

As for Intellicig, who make Ecopure, they'll still be selling ecopure - in 0.3ml cartridges, packed five to a blister card at £5 a card into the NRT market and laughing all the way to the bank while all the other vendors go bust or group together to try to take it all to court. In terms of bottles of juice, they will have no choice - they'll be stopped.

The battery part of the e-cig will not be subject to MHRA regs as I understand it..The definition in that document can only be interpreted to be the e-juice ie., the nicotine containing product. See, I can read too.

They may make it hard or impossible to obtain nicotine containing products and may do all the things that you said. Only time will tell.

It is inevitable that MHRA approval is going to be granted. I'll cross that bridge about how to carry on the way I am when I get there instead of agonising about it.

All I can say is this. Whatever regulation they bring in, they'll find it damn hard to impose it. The constituents of e-cig batteries and e-juice are too general and too commonplace for them to do bugger all about it when it comes to enforcement.

Speeding is illegal too. Yet it goes on so much and criminalizes so much of the population it becomes inane. Like you said earlier, nicotine is banned in Australia. And yet they do carry on. I think that's what will happen here too. Time will tell.

[alvoram]

Apr 14, 2012 21:42:26 GMT @colliwobbles said:

got to agree with hi fi on this one
you cant buy patches tablets or any other nrt's from any where except chemist's if you did you cant be sure of whats in them
and the same will be for cartos and ecigs unless you met a guy in a long mac saying ere mate wanna buy some ejuice
It happened with viagra and fake vodka and has some dire consequences
better we use and promote within rather than have it classified and restricted
for those it may benefit (the poor etc ) will find a way around giving up buy sticking with their black market suppliers
at least those of us that are a litlle informed can produce our own mods atties and juice if you can get hold of a legit source of nicotine mix, but most (me included) wont know therefore will continue with their habit and be none the wiser to a wonderful experience as vaping

Not trying to get involved in this again, because I've decided I want to study more, until I can honestly say I understand the implications fully, but I have to say, you are wrong there, NRT can be bought from the pound shop mate I bought a shed load of nicorette gum on a previous quit attempt, then realised it tasted like.... well you get the point. And savers were doing boxes containing enough patches, and gum for 1 week. Home bargains also sell most types of NRT.

[Perpetua]

Apr 14, 2012 22:00:01 GMT Karma said:

I would like to hear the vendor's views on this ?

I doubt very much that you'll hear many/any Vendor's honest thoughts on this to be truthful Karma . . . I don't say that as a criticism of them.

It must be concerning times . . . and I'd think the responsible ones are working very hard to try and ensure the future of their business, so won't want to commit their views or add comment to the discussion on forums.

That's my personal thought anyway.

[Karma]

Apr 15, 2012 6:06:35 GMT Perpetua said:

Apr 14, 2012 22:00:01 GMT Karma said:

I would like to hear the vendor's views on this ?

I doubt very much that you'll hear many/any Vendor's honest thoughts on this to be truthful Karma . . . I don't say that as a criticism of them.

It must be concerning times . . . and I'd think the responsible ones are working very hard to try and ensure the future of their business, so won't want to commit their views or add comment to the discussion on forums.

That's my personal thought anyway.

Bit cryptic for me Perps

I understand they must be worried, just interested to hear their take on this

As one of the most committed vapers I know, Perps What's your contingency plan?

[maccafan]

Those who are interested to read up on the entire consultation process and what people and professional bodies wrote during this process can visit the links below:
To understand the options:

The Consultation

The responses. Free up some time but it's worth reading.


Clicky

[VE Jason]

Apr 15, 2012 10:29:11 GMT Karma said:

Apr 15, 2012 6:06:35 GMT Perpetua said:

I doubt very much that you'll hear many/any Vendor's honest thoughts on this to be truthful Karma . . . I don't say that as a criticism of them.

It must be concerning times . . . and I'd think the responsible ones are working very hard to try and ensure the future of their business, so won't want to commit their views or add comment to the discussion on forums.

That's my personal thought anyway.

Bit cryptic for me Perps

I understand they must be worried, just interested to hear their take on this

As one of the most committed vapers I know, Perps What's your contingency plan?

Perpy has pretty much hit the nail on the head Karma

There's plenty going on in the background and I'm sure there are several vendors who are making plans at the moment.

We have been in talks with various bodies for a while now and will be doing all we can, but at the end of the day each business does need to look after it's own interests primarily.

The saying "you snooze...you lose" is pretty much appropriate for the current scenario and anyone who just sit's back and waits will not be trading in the not too distant future.

[Karma]

Good luck with it Jason

[hifistud]

The battery part of the e-cig will not be subject to MHRA regs as I understand it..The definition in that document can only be interpreted to be the e-juice ie., the nicotine containing product. See, I can read too.

Then you nee to read the bits in the supporting documentation that tell you that if a piece of hardware is necessary for the use of - in this case - e-liquid, then it, too can be considered to be a medical device for the purpose of the MHRA. It's a combination drug and drug delivery device, if they so wish it - and they have the legislation and evidence so to do.

They may make it hard or impossible to obtain nicotine containing products and may do all the things that you said. Only time will tell.

Here's a question for you... why do you think that Totally Wicked has offices and warehousing off-shore? Why do you think a number of vendors are making plans to move off-shore, to places like, say Spain??

Y'know, I really want to be wrong about all of this - I do, but experience of two other regulatory consultations tells me that I'm not far from the mark here... The MHRA will get what it wants - the question is one of time, and we really need to stop equating e-cigs with quitting. Remember, evidence needs to be contemporaneous, and if the general perception of e-cigs is that they're simply a way to carry on smoking with a much lower risk profile, then that's one skirmish won.

If you're on Skype, Maccafan, I'd like to invite you onto VT Talk on Wedesday to discuss this further - choice is yours.

[maccafan]

Apr 15, 2012 11:38:47 GMT hifistud said:

Then you nee to read the bits in the supporting documentation that tell you that if a piece of hardware is necessary for the use of - in this case - e-liquid, then it, too can be considered to be a medical device for the purpose of the MHRA. It's a combination drug and drug delivery device, if they so wish it - and they have the legislation and evidence so to do.

Possibly but I doubt the MHRA have batteries in their sights...A pre-filled cart yes, but a battery no.

Regardless it's unenforceable..

Here's a question for you... why do you think that Totally Wicked has offices and warehousing off-shore? Why do you think a number of vendors are making plans to move off-shore, to places like, say Spain??

Y'know, I really want to be wrong about all of this - I do, but experience of two other regulatory consultations tells me that I'm not far from the mark here... The MHRA will get what it wants - the question is one of time, and we really need to stop equating e-cigs with quitting. Remember, evidence needs to be contemporaneous, and if the general perception of e-cigs is that they're simply a way to carry on smoking with a much lower risk profile, then that's one skirmish won.

If you're on Skype, Alvoram, I'd like to invite you onto VT Talk on Wedesday to discuss this further - choice is yours.

Well every business seeks to protect itself and if they think its more economical for them to move to Spain given the current climate that's what they will do. Just like Amazon are doing to dodge the tax bill and the previously exploited Guernsey loophole in tax laws.

Almost every single email by individuals that was sent to the MHRA in response to the consultation talks about how much they used to smoke and how they gave up using e-cigs. So it's a moot point under which guise you are planning to categorize them now.

What's currently stopping a 12 year old from freely buying e-juice in the UK today?

Anyway, like I said before, bringing in a regulatory framework is one thing..Enforcing it is quite another..You cannot make aspirin or aciclovir at home touching on something you said a few posts earlier.. E-juice is a different matter.