255 replies to this topic

[prof beard]

Excellent bit of work Dave - some good points made in there

[Crossbow]

Well written, and it makes a lot of sense :)


I realise it's just a draft, but I did notice one slight error in the impact assesment that is spell check proof

Quote

The current market is mall

[hifistud]

Yup - spotted it as well... after I posted, naturally! Now edited.

BTW, just got off the phone from our local MP's offices. He'll be ringing me Friday to chat some of this stuff through. I'll let folks know what the SP is when I've spoken to him.

[Jackie]

Good stuff Dave, well done. :)

[Kate]

I've just sent this to a load of people:


Hi

1st February was a big day in the UK for the future of smoking alternatives. It was announced that only tobacco companies will be able to sell recreational nicotine. This will take the very effective electronic cigarettes out of the hands of citizens and onto shelves until pharmaceutical companies bother to reinvent something that works for a change. Since their interests lie in keeping people addicted - their dependent and now captive market, that seems unlikely - or at least not before many many lives are destroyed first.

Another public health disaster for the government. They have not learned from the mistake of banning Swedish snus - the least harmful tobacco product that is banned in the EU but not in Sweden - where they have the lowest harm rate from smoking in the world. It's possible that banning snus has stopped 50% of people from finding an acceptable smoking alternative (compare with the failure rate of 95% for NRT).

... Currently, snus is banned in all EU countries except Sweden. While it cannot be proven that the availability of snus would reduce smoking prevalence in other EU countries, our study shows that snus use has had a profound effect on smoking among Swedish men. It also reveals that 274,000 smoking-attributable deaths would be avoided if all men in all EU countries had the smoking prevalence of men in Sweden.

In 2008, an article in the prestigious medical journal Lancet argued that “…the absence of effective harm reduction options for smokers is perverse, unjust, and acts against the rights and best interests of smokers and the public health.” Our study clearly shows that, snus has the potential to help the EU avoid 274,000 smoking-related deaths every year...

http://rodutobaccotr...w-swede-it.html

The UK Department of Health, NICE and MHRA announced that nicotine is to be allowed only from tobacco or medical products.
http://www.dh.gov.uk...t/dh_111748.pdf
http://www.nice.org....onToComment.jsp
http://www.mhra.gov..../MLXs/CON065617



[ame][/ame]

... If [electronic cigarettes] are so good, why aren't governments and anti-smoking groups supporting them?

We do not know for sure. There does not seem to be a concerted effort to block these products in most countries, though that remains a possibility. Regulatory agencies have a legitimate responsibility to help make sure the products are pure and contain what they say. This creates a challenge in the current environment. Groups that are truly anti-smoking should embrace any alternative, but those that are more interested in making life difficult for smokers or nicotine users do not like these products because they could make nicotine users more comfortable.

Whenever government regulatory agencies are confronted with a new product, they need to find the proper category to put it into, and then make sure it complies with the standards associated with that category. In this case, even though nicotine is widely available in many forms, it is still important to make sure the products do not contain any hidden toxins, that they function properly (e.g., cannot accidentally deliver an overdose), and so forth. In this case, the waters have been muddied by the claims that it helps people quit smoking. Whether or not it does is not the concern of the agency, but when such a claim is made, the claim needs to be proven (and that means more than anecdotes).

In some sense, the situation is absurd because someone could introduce another harmful product that was part of an already established category. Governments typically worry more about hypothetical new risks than clear old risks.

Some commentators have suggested that governments are so used to tax revenues that if electronic cigarettes became more popular they could threaten this income. This is not an absurd concern, given the current economic conditions and given that governments have been raising tobacco taxes to make up shortfalls in other areas. We can only hope that if that is the plan, that they keep the taxes lower than on tobacco products because the last thing you want to do is make people choose traditional cigarettes because they are cheaper.

However you do hear official spokespersons from both government, NGOs and anti-tobacco agencies making statements that either betray ignorance of where the harm in smoking comes from, or statements that are ideological rather than concerned with health.

You might hear that e-cigarettes are dangerous because they deliver nicotine which they say is a poison. See our nicotine FAQ for why this has little basis. You also hear people say that these just keep people smoking. That may sound like a health statement but it is simply expressing an opinion that no one should smoke, not even if it is entirely safe. This statement ignores the public health harm reduction principle that we should do all we can to protect the health of those who choose to smoke, and part of that protection involves educating people about the comparative risks of these products and in promoting the safer options. Or you might hear that this will lead people to smoking. This makes little sense since it is much easier to obtain traditional cigarettes, and what you hear most from people who enjoy these, is that apart from being able to smoke inside again, they feel they are making a healthier choice.

We like to think that those against will realize that e-cigarettes (and smokeless tobacco) remove all that second hand smoke they are so worried about, and also remove the health risks associated with nicotine use. How can you argue with that?

At the very least, we hope that anyone who has doubts about these products will realize that the elimination of second hand smoke and a likely reduction in health risk will mean that governments will eventually come to approve them. Anti-nicotine extremists, on the other hand, might stay with their goal of trying to punish smokers rather than offer them good alternatives...

http://www.tobaccoha...g/faq/ecigs.htm

There is now no point in innovation and development of effective smoking alternatives, they won't be allowed on the market for anyone but the big pharm and tobacco monopolies who would be acting against their vested interests if they actually helped people to be less dependent on them.

This petition illustrates the value and effectiveness of keeping affordable and attractive harm reduced alternatives on the open market, please support our request to be allowed to keep the liberty to choose our own habits - http://www.petitiono...g/petition.html

Kate B.

[Raff67]

Hi Kate, just a question about the part about snus...you write it's banned in all eu countries except Sweden ? I'm under the impression that it is only portion snus that is banned but loose snus is still available to buy, it certainly is in Denmark where I am right now.

[Starlight]

Kate, I just want to thank you for all the continued efforts, hard work and commitment you put into all this for so long now, for all of our sakes.

Like with so many, you were the first to welcome and help me along my way when I first joined forums about a year ago. I always looked to your posts then and I continue to do so now, especially during this moment of total uncertainty about our vaping future.

Thanks again, and thanks to the others here too who are also trying what they can. I wish I could help in some way but I'm afraid I don't have the ability...

[Kate]

Hi Raff. I'm sorry but I know very little about snus except that they're better than NRT, I was quoting Dr Rodu but I've heard others say that snus are banned. It might just be certain types as you say.
http://rodutobaccotr...w-swede-it.html


Thanks Starlight. Don't worry about being able to participate, we can all just do whatever we can. We're up against the pharm and tobacco companies as well as control freaks so this is going to be a long fight, might as well get a cup of tea, put your feet up and have a laugh at their expense if you can.

[westcoast2]

Well written Dave.

The consultation continues until 4th May 2010 and seems to have been sent out to all and sundry. It will be interesting to get other supplier povs.

They are asking for comments on the options and the impact accessment. The options are stark with options 1/2 essentially the same except for timescale as Dave noted.

There concerns as Dave's note shows are quality, safety and efficacy.
They also want comments on the impact assesment.
They do not seem to have been very thorough on the impacts, having done no specific impact tests (see page 26)
They also claim these measures will have no impact on competition. (Page 19).

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It maybe worth addressing the efficacy (Therapeutic benefit) issue in their terms.

Quote

The indication in full is:
“Nicorette inhalator relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.
Nicorette inhalator is indicated in pregnant and lactating women making a quit attempt.
Nicorette inhalator should preferably be used in conjunction with a behavioural support programme”.

There are a couple of issues here. The e-cig fits the first part, not sure on the second and I'm pretty sure the third part wouldn't go down well.

It is clear that the intent is to regulate NCPs including the e-cig as a medicinal product. It may be possible to introduce another option as the e-cig clearly doesn't fit the complete medicinal profile. In the US it falls on the tobacco product side (for the time being), yet still this is not the correct place. It maybe worth argueing catgorisation/regulation (Option4) while showing that the e-cig could fit mainly into the medicinal category wrt quality, safety and efficacy with the exception of the quit issue. A regulated NCP without the medicinal tag. There is a problem with this arguement in respect of other products that may fall within its scope,

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The Impact assessment is worth reading. Its main argument seems to be that unlicensed products could put people off licensed NRT and thus quitting. Due to this effect (which seems to have no supporting evidence) people will continue to smoke causing smoking illness and second hand smoke illness leading to increased costs to the NHS. (pages 23-24)

They also argue that if unlicensed products are removed, people will choose licensed NRT which will lead to more people quitting and therefore lower costs.

This argument clearly makes no sense when e-cigs are factored in.
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They do refer to the FDA report and suggest efficacy and quality issues due to the variable nicotine dosage and safety issues bassed on the TSNAs and DEG.

Since the FDA report, NJoy have released a report showing that their catridges do not contain TSNAs (I think the FDA report showed this too)
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Perhaps if people addressed parts of the IA and gave the page# a general picture will emerge of how this consultation can be addressed. Firing off any old rant will probably be ignored.

We can build on Dave's draft, then customise/individualise it with other points we discover. Thus there is a core theme with individuals presenting additional thoughts. This way it will be possible for points to be raised that they will need to address, without each person rewriting war and peace.

(And perhaps it is time for that documentary?)

just some thoughts
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Edited by westcoast2, 02 February 2010 - 08:20 PM.

[hifistud]

Their impact assessment fields are barren because, as yet, they have no figures to work from - they simply do not know the extent of the market at all, as evidenced by their assumption that there are 24 manufacturers of NCPs in the UK. Clearly, there's nowhere near that number of e-cig or e-juice manufacturers in the UK, and probably not in China, come to that!

At this meeting on Friday, I want to find out exactly how they intend on applying the system of approval applications. Thus far, for current licensed NRT, it looks as though each individual product has been subject to approval. So, not just "gum" but Mint Gum 2mg, Black Cherry Gum 2mg, Mint Gum 4mg, Cow Pat gum 4mg etc etc etc... at £28,000 a pop, there's no manufacturer in the UK at present that could afford to get approval for each of their juices.

Even so, my argument is that all that is necessary is Type Approval, such as there already exists for caffeinated carbonated drinks - that is to say that a maximum level of, say, 70mg/ml of BP grade nicotine, and liquids subject to random testing by a designated government agency at its own expense with deviation from the rules attracting a fine for the manufacturer or UK distributor.

[Jackie]

Everyone, I'd just like to say thanks for all your contributions to this thread. I've been quiet on the subject today but my mind has been working overtime (it's not often it manages that lately, lol).

I've jotted down some very rough notes for a letter but I'm going to take a few days to make sure I get it right. Maybe also wait for more of the suppliers to chime in and get their points of view, and of course the outcome of Dave's phone call with his MP on Friday.

[hifistud]

Well, one outcome is already assured, and that is that my MP will table a question of the relevant minister. Quite when that will happen is anyone's guess, but I've been assured it will happen. His office is also very aware of what they called "acute time scale". So far, I'm slightly optimistic. Only slightly (as in a value approaching 0.001), but there seems to be a small, faint glimmering ray of hope...

[Kate]

That's great Dave, good work.

I've written to a lot of politicians, gubment departments, traders, harm reduction experts and the media. One angle is about closing down the nicotine market to competition and how that's promoting tobacco and pharm companies interests.

Every little helps and more points of view give a better picture.

[hifistud]

There's another compelling argument, and it goes as follows - and this is one I'm seeking to pursue with Kemp...

Currently, UK.GOV has timetabled a massive move towards a SmokeFree Britain, aiming to cut the number of tobacco smokers to around 10% of the adult population by 2020. This is mostly a health issue, and is brought about by the acknowledged harm that smoking tobacco can, and does do, not only to the smoker, but those inhaling and being exposed to second hand tobacco smoke. The figures are unarguable, and there is no need to inflate them. Smoking Tobacco does massively increase the risk of premature death from painful illness.

So, legislation has been brought forward that is specifically aimed at the carcinogenicity of tobacco smoke. The legislation is not aimed at Nicotine, which is, by the DH and UK.GOV's own admission, "a very safe drug".

In Electronic Cigarettes, what we donot have are the very things that legislation is designed to protect UK citizens from - the Carcinogens, Carbon Monoxide and other harmful by-products of burning tobacco. What we do have is the one thing that the legislation has no need to protect us from - the Nicotine. One would almost have thought that Electronic Cigarettes were designed to allow people to "smoke" without causing harm to either themselves or others, to allow people the freedom of choice to use a "very safe" drug in the same class as Caffeine, and to give UK.GOV the opportunity, by promoting their usage to tobacco smokers, of saving many, many more lives - and co-incidentally, money.

A sensible and caring regime would not only welcome such devices, but would actively encourage their use as an alternative to smoking tobacco. To take the stance that, because Electronic Cigarettes mimic the nicotine delivery of traditional tobacco cigarettes, they must therefore be drug delivery devices, and therefore subject to exactly the same sort of clinical trials and approval procedures that extremely dangerous drugs like, for example, Chemotherapy agents must go through is hardly a sensible response.

[prof beard]

It looks like things are about as bad it is can get.

Have a look at Jason's posts from today on:

http://forum.totally...299.0;topicseen

[Jackie]

This is so depressing. :(

[Sky]

It is depressing and not good at all :mumbles:

[Jackie]

Over on the TW forum Jason is calling for testimonials, would that help all retailers? I'm sure as customers many of us would be quite happy to provide them to our favourite retailers. Or would it not serve much purpose?

I think we could probably do with a stickied post containing details of all this so that people can see the info at a glance.

I'm so bloody angry....I'm lost for words, I really am.

[prof beard]

The important thing is that as many people as possible a) respond to the consultation b) write to their MP c) sign Kate's petition.

As a Prof (although not in a medical discipline) I shall be making a response which is critical of their research/methodology at arriving at this proposal and also at the apparent complete lack of IMPACT ANALYSIS - ie what will be the effect of regulation? Who will be affected? How many? What sort of people? etc etc

[Kate]

It would be good if you would consider mentioning that the more they interfere the more damage they do. They've killed millions so far and are just getting more and more fundamentalist in the restrictions they introduce to attack smoking and smokers.