MHRA publishes its decision: option 3 do nothing!

[freakindahouse]

Very happy no smoking day, my vaping friends!

The MHRA has indeed published its decision at long last! Here is ECITA's press release:

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.

[FONT="][/FONT] 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.

 

[rolygate]

Fabulous news.

The result has been avoided in every possible way by the MHRA and even their PDF announcing it tries to squirm out of discussing it properly.

To be honest I'm amazed that logic and common decency has prevailed both here and in the US courts, I had been far more cynical about the outcomes due to the amount of money at stake. Essentially we have a reprieve in both the US and UK now. How long that will last is debatable

The UK situation looks good since the regulatory push has been defeated. Two things can overturn that: the return of the socialists to government, and a negative decision by the EU, which could not be ignored in the UK. It looks as if the 'research project' ending in Q2 2013 won't have regulatory authority; but any EU decision would probably overrule whatever is decided - good or bad - in any case.

I think the positive UK result has been influenced by many things: principally the change of government of course, but also the US courts' decisions, since that provides a wealth of legal basis for the avoidance of classification of electronic cigarettes as drugs; the new strength of the RPC; and pressure from the community and others.

 

[CES]

That's fantastic! I'm so glad that reason and common sense has prevailed for now. Goes to show that a strong suppliers coalition can work- hope the US suppliers take note.

 

[Vocalek]

Wonderful news. Now can you come over to the colonies and straighten out our muddle-headed government?

 

[rolygate]

I believe the FDA US defeat helped in the UK, Elaine. The main factor is that the new UK government is against increased regulation, and enforced their view.

Now the fight will be on to avoid the FDA strangling e-cigarettes by overbearing minor regulations as tobacco products. That will be another battle - or series of battles.

 

[DaveP]

I'd like to know how much of the pressure is being created by Pharma and Big Tobacco. There are huge profits to be lost on each side and they have to be lobbying heavily to protect profits.

You'd think that the health of the public should be the prime motivator here. This is apparently not so.

 

[freakindahouse]

Wonderful news. Now can you come over to the colonies and straighten out our muddle-headed government?

I shall be starting that work soon, Elaine, and hope to work closely with you as well as with Julie, Treece and our US vendor(s)!

What a glorious day! Finally, we have a demonstration of the inability of government agencies to be able to deny their own laws. (I almost feel sorry for them all... honest )

 

[freakindahouse]

I'd like to know how much of the pressure is being created by Pharma and Big Tobacco. There are huge profits to be lost on each side and they have to be lobbying heavily to protect profits.

You'd think that the health of the public should be the prime motivator here. This is apparently not so.

The thing is, that no matter how much Big Pharmacco attempt to lobby for their own agendas, policy makers cannot afford to be seen to have any other prime motivator THAN the health of the public, which paints them into a corner.

And thank god for that!

 

[pianoguy]

That is most encouraging news!!

 

[Papa Lazarou]

Great news

I like the fact that you can see all of the submissions on the MHRA website - even the idiotic ones in one or two of the e-mails.... Some of them make interesting reading, for example it surprised me that ASH did not want the products to be immediately withdrawn from the market.

 

[Oliver]

Papa Lazarou - ASH UK took quite a different line on the whole business to ASH US. It surprised me too when they first stated that they didn't want them removed from the market.

I suspect that, freed of the dominating influence of Banzhaf, they're able to think more clearly about what actually matters for the wellbeing of smokers.

 

[rolygate]

I'd like to know how much of the pressure is being created by Pharma and Big Tobacco. There are huge profits to be lost on each side and they have to be lobbying heavily to protect profits.

You'd think that the health of the public should be the prime motivator here. This is apparently not so.

As far as we can see the pressure originates, now, exclusively from the pharma industry, who stand to lose most, when NRTs become obsolete. The tobacco industry seems to have come around to a pragmatic stance: it is impossible to halt ecigarettes as once the genie is out of the bottle, you can't put it back - and no legislation of any kind will prevent the public from obtaining something they want; and as pressure from all sides increases on tobacco sales, alternative income streams will be welcome, and that means smokeless tobacco products (see their trade journals for confirmation).

I've been surprised by the way both US and UK decisions have gone our way, taking the huge sums of money involved into account. Health is hardly an issue here, there are other concerns - for example in the UK, the e-cigarette regulations proposed would have been among the worst-framed that have been presented recently, with zero facts and ludicrous numbers quoted to justify the proposals - and the RPC will have been working in the background to nullify the proposals since otherwise they would be seen as ineffective and inconsequential (they are the body that now regulates the regulators, and wonder of wonders, appear to have some teeth).

However it remains to be seen what will happen when the tax shortfalls start to hurt. When 25% of smokers have converted, the revenue loss will be painful, so expect tax to be placed on ecigs in some way. After all if they are tobacco products then they can be taxed as such.

I was also surprised to see the RCP's (Royal College of Physicians, the doctors' governing body) response to the MHRA given that they appear to support harm reduction initiatives now. They voted for Option 1 regulation, although that would in effect mean the removal of 99.9% of products from the market and the removal of ecigarettes as a consumer option - in effect a ban. Perhaps they didn't realise the effect. Or perhaps as medical people they think they are the only ones with any right to decide on consumer purchases for the individual if that affects health. A position which directly prevents any significant improvement in public health, as day-to-day decisions are far more important than medical solutions. After all, any GP will tell you that 80% of patients in their surgeries are there because of lifestyle decisions, not genuine and unavoidable disease. It's far too late when the medics get involved.

By that time you could be CTD, GPO or in the Departure Lounge.

 

[rothenbj]

This news brought me to a one word thoght, Perfectionist! Congrats!

Dang phone word exchanger

 

[BenP]

Fantastic news!

 

[Placebo Effect]

British Heart Association has a whole lot more sense than the American Heart Association.

Requiring all unlicensed NCPs to be removed from the market within 21 days could protect the public. But for people who may be in the process of attempting to quit using these products, or using them to reduce the harm from tobacco, the sudden removal of these products could push people back towards cigarettes. This would undermine the harm reduction strategy adopted by the Department of Health. The impact assessment assumes that 50% of existing products would become licensed - it is important therefore that these products be given sufficient time to apply for an MA.

 

[Placebo Effect]

Great news

I like the fact that you can see all of the submissions on the MHRA website - even the idiotic ones in one or two of the e-mails....

There are plenty of warm, thoughtful, and intelligent letters that I've read so far. And then there's ...

My comments on the proposal:

Don't you bleedin' well dare. You appear to wish only harm on the public by restricting the only safe alternative to tobacco products, by supporting this all youare going to do is prove to the vaping community that you are in the pockets of Big Tobacco.

Had you actually done a study, instead of sitting on your fat arses taking bribes from people like Phillip Morris and his Tobacco pals, you might actually realise that vapourised nicotine is far safer than cigarettes. Unless, of course, you're a smoker yourself, in which case, hope you get lung cancer soon.

 

[e-pipeman]

Very, very good news!

 

[Papa Lazarou]

There are plenty of warm, thoughtful, and intelligent letters that I've read so far. And then there's ...

Yes that is one that I was thinking of

 

[Bill Godshall]

Congratulations to ECITA, the ECF and others for convincing MHRA to do nothing, and to continue studying e-cigarettes.

The situation in the US is looking very promising, as we've defeated efforts by the FDA and legislators in five states to ban the sale of e-cigarettes. When the FDA proposed regulating e-cigarettes as tobacco products, I'm confident that we'll have another major one or two year battle, as I suspect that the FDA will propose dozens of unwarranted regulations that are intended to deny adult consumers of affordable e-cigarettes (and perhaps to deny adult consumers of legal access to some/many e-cigarette products).

 

[ckc]

NICOTINE CONTAINING PRODUCTS

Question and answers from the MHRA.