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Outcome of MLX 364

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#1
ecigsoutlet

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fyi

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You may wish to be aware that the MHRA has today published on its website, the outcome of public consultation (MLX 364) on the regulation of nicotine containing products as medicines.

The responses to the consultation have been placed on the MHRA's website and can be accessed via the link below.

Kind regards

Amanda Bryan
Strategy & Business Manager
Vigilance & Risk Management of Medicines Division
MHRA

http://www.mhra.gov..../MLXs/CON065617

In a nutshell (as I read it) extended until Spring 2013

#2
doodlebug

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Yes, it's true! Here's ECITA's press release, which is also on the blog:

PRESS RELEASE

9th March 2011


ECITA Ltd was contacted this morning by Jeremy Mean at the Medicines and Healthcare Products Regulatory Agency (MHRA) to inform us of the outcome of their public consultation MLX364 concerning the regulation of nicotine containing products. He explained that he wanted to let ECITA know at the earliest opportunity, and did so just before the results went up on the MHRA website. They are now there and ECITA will provide further analysis in due course. The outcome of this consultation has been published today to coincide with the publication of the coalition government’s publication of its Tobacco Control Plan for England.

Mr Mean explained that the MHRA has decided to adopt option 3, do nothing, with a view to undertaking more research over the next 18 months. He asked for ECITA’s assistance in this regard, and we have pledged our support both to the MHRA and the wider Department of Health in sharing research resources, and more broadly engaging in the process of demonstrating the safety profile of electronic cigarettes, and how they can be used as part of the wider government Tobacco Control programme. Mr Mean indicated that he would like to meet with ECITA sooner rather than later to begin this process, and we have told him that we shall be very happy to meet with them at their convenience.

Mr Mean apologised for not having been able to provide us with this information any sooner, particularly since we had spoken only last week about this very issue. He explained that, due to the ongoing legal case in the UK (with Big Tobacco suing the UK government over the removal of vending machines from pubs, clubs, etc.), he had been unable to provide us with this information any sooner. He has, however, told us as soon as he was able to, and indeed, before the information was made available to the wider public.

ECITA would like to thank Mr Mean and the MHRA for the spirit of co-operation they have demonstrated. We look forward to working closely with them in the coming months, to assist them and the wider Department of Health, in making sensible and appropriate policy decisions concerning the regulation of electronic cigarettes, and indeed any help we may be able to offer concerning the wider issues of Tobacco Control to ensure true freedom of choice for nicotine users.




Very happy no smoking day, my vaping friends! :p

Edited by doodlebug, 09 March 2011 - 11:39 AM.

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#3
PinkVaper

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good news thanks to the OP for posting and to katherine for the info.....well done all the hard work has paid off....on a personal note if i can help over the next 18 months with anything my hands up to do so....

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#4
Jackie

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I'm smiling like the cheshire cat right about now. Soooo pleased!

A massive well done to everyone who worked so hard to obtain this outcome.

I think right about now is time for the victory dance, no? Happy days!

#5
PapaLazarou

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Great news :marchmellow:

#6
Toby

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I wonder if those people that wanted e-cigs only available in chemists in two exciting flavours, are going to feel proud of them selves now?

Great result! Well done Katherine! :)
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#7
dodderer

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The list of respondents is fascinating - 1 individual wanted Option 1 as did Imperial Tobacco.I would love to read their submission :mstickle:

#8
grizwald56

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A happy vaping day to one and all.

Makes you feel like breaking out the bubbly, or vaping it.

This is certainly good news for all vapers in the UK, let's hope things go as well for the US.

Brilliant work from ECITA and Katherine. Keep it up.

Edited by grizwald56, 10 March 2011 - 10:38 AM.

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#9
Kingtut

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Katherine ,what fantastic news and alot of that success ,can be put down to your`s and ECITA`s very hard work on the subject, well done girl!! :party2: :party2:

Edited by Kingtut, 09 March 2011 - 01:24 PM.

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#10
Bruce

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Fantastic, well done ECITA, and Katherine, sterling work indeed.
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#11
prof beard

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Great news - and thanks is due all those who contributed to the "effort"
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#12
westcoast2

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A good result. The (anti-smoking) PTB were stacked against us, yet the MHRA have (and good for them) recognised the need for more research (beaurocrateze for we lost!:)). It will be interesting to see how the anti-smoking groups react to this.

The vaping community has made a difference. There is now an opportunity to press the case over the next 18 months.

edited to correct a spelling mistake and add.....

Is this an endorsement of the view that e-cigs do not present an immediate Public Health Issue?

Edited by westcoast2, 09 March 2011 - 01:14 PM.

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#13
zebbydog

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View Postdodderer, on 09 March 2011 - 12:31 PM, said:

The list of respondents is fascinating - 1 individual wanted Option 1 as did Imperial Tobacco.I would love to read their submission :mstickle:

Its there to read, document 1016 all 12 pages of it. Be warned it the usual lies hypocrosy and bullshit and blowing their own trumpet sort of stuff.
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#14
acousticvillage

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Doodlebug...great news!! We also seem to have this coincided with the news that the Govt plan to ensure that cigarettes are sold "under the counter" in plain wrappers from 2012.

It used to be porn that was sold that way!! How times have changed. Perfectly acceptable for 10 year olds to see and buy magazines that totally sexualise children and trivialise the sexual act and yet adults have to engage in a load of winking and crafty nods in order to buy a packet of fags!!!

Now we have 18 months or so, I believe the whole vaping community - and certainly the good burghers of UKVapers (a right load of burghers at times) - would be willing to contribute to any information, research, questionnaire, data collection that you and ECITA might find helpful.

Just say the word! We could really develop a campaign and information base that would inform and influence decisions.

Jim
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#15
homerprr

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Great news - well done Katherine and ECITA and to everybody involved :whoohoo:

#16
doodlebug

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Prof's absolutely right. This was a team effort, and there were many, many peeps - across the vaping community, here and abroad, and across various other agencies, here and abroad, who all contributed to this outstanding result.

That said, I do believe that the formation and ongoing success of ECITA was a significant part of this victory, since it gave our industry the beginnings of the credibility it so desperately needed. We are now in the glorious position of having the ear of government, and the dialogue is open, established and ongoing.

Nevertheless, I certainly offer my sincere gratitude to EVERYONE who has worked so hard to make this happen.

Happy days, peeps ;)
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#17
prof beard

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Indeed - ECITA has been a big part of this success and you deserve praise heaped upon you. Consider yourself thoroughly hugged :)
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likewise gold and jewels,
but I would slave to learn the way
to sink your ship of fools

#18
westcoast2

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View Postzebbydog, on 09 March 2011 - 01:24 PM, said:

View Postdodderer, on 09 March 2011 - 12:31 PM, said:

The list of respondents is fascinating - 1 individual wanted Option 1 as did Imperial Tobacco.I would love to read their submission :mstickle:

Its there to read, document 1016 all 12 pages of it. Be warned it the usual lies hypocrosy and bullshit and blowing their own trumpet sort of stuff.

Yes it does and they seemed to miss the point somewhat. Some of the things they say are interesting....

Quote

...no government authority has yet adopted regulatory standards by which one cigarette (or tobacco product) could be regarded as safer than any other. It is our view that the relevant goverment auithorities should define the objective criteria and predictive tests by which products can be judged to have potentially reduced risks. It is only in this context that we can place such products on the market, in the knowledge that thier potential to reduce risk has been established in a framework of approved standards

This is a direct challenge to get a regulatory authority to establish standards. The mantra 'there is no safe cigarette' has prevailed and this means no criteria matters. This has tainted the e-cig as well as other products such as Snus. If the government is really embracing 'harm reduction' then they should be challenged on objective criteria. They will resist as it opens up a really big can of worms. The e-cig is actually a really big challenge in this area as the ingredients are so few, nicotine has not been shown to cause cancer and e-cigs have not been shown to be a public health hazzard (FDA unable to produce evidence at trial, despite having experts submitting oprions they hoped would be accepted as fact).

Also the Imp Tob addresses the complexity of 'Nicotine Addiction' and says it is not as simple as being addicted to nictoine. A view I have presented here and now accepted by the likes of Dr Siegel. Indeed e-cigs seem to suggest the opposite. If nictotine were as addictive as claimed many here would not have reduced their nic content to zero. The zero nic e-cig is certainly an interesting case.

Imperial Tobacco supported Option 1, though in these circumstances

Quote

Imperial Tobacco agree with Option 1 that marketting of unlicensed medicinal products should cease within 21 days


Many would agree with this and certainly 'unlicensed medicinal products' should be removed from the market unless their are other regulatory provsions. I think this is where Imp Tob show they really missed the point. They failed to think about the status of e-cigs. Most E-cigs are not medicinal. Indeed at the outset of the consultation it was pointed out that making a medicinal claim could have the product banned under current legislation and would certainly push to MHRA to regard them as medicinal (NRT).

Imp Tob should have followed through on what they said in the earlier quote and supported option 3 while still making the point about unlicensed medicinal products. This position (which we now have) does not only benefit e-cigs but also products such as Snus.
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#19
zebbydog

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Good post. We all know that there is only one thing that IMP are concerned with and what that thing is.
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#20
Dave

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ECITA would like to thank Mr Mean and the MHRA for the spirit of co-operation they have demonstrated

Yes indeed..

A great result .... well done to all concerned,

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