255 replies to this topic

[Mr Darcy]

yeah i remember that Kate.

dry throats,PG allergies and the odd person vaping a higher mg than they needed.

thats about all i can think of.

[Alice]

A quick hopefully not dumb question. How does hookah tobacco come out under this legislation? It contains nicotine.

[Rusty]

Good question Conc!! Does it?? Or does it fall under the Tobacco Legislation?? What is the Tobacco Legislation re: none smoke producing tobacco??

[Kate]

I don't think anything is changing about tobacco products whether you intend to burn or vape them. Iolites are going to sell well I think.

[Rusty]

Well let's change tack then Kate. Eliquid containing nicotine is a tobacco product - isn't it??

[jigtg]

Concupiscible said:

A quick hopefully not dumb question. How does hookah tobacco come out under this legislation? It contains nicotine.

No, hookah molasses are considered tobacco products and are taxed as such. Since hookah molasses contain only small amount of tobacco that has driven driven prices after taxes so high that no one sells them.

[Kate]

Rusty said:

Well let's change tack then Kate. Eliquid containing nicotine is a tobacco product - isn't it??

We might have to resort to that argument Rusty if our nicotine is derived from tobacco. That's what they did in the States.

Personally I don't like the market being closed at all, I'd prefer non-tobacco and non-medical nicotine to be freely available.

[westcoast2]

Quote

I'd prefer non-tobacco and non-medical nicotine to be freely available.

you mean like Doctors say (apart from the patronizing 'in order to help' bit.)

Quote

Nicotine should be freely available in products that do not carry messages about cigarettes' health risks, in order to help smokers who find it difficult to quit, say doctors.

Quote from CRUK site --> http://info.cancerre...idely-available

If it is safe enough to be made freely available, without warnings, then why the need to regulate as a medicine or as 'help'?

(I know they then go on to talk about 'medicinal' nicotine)
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[Alice]

jigtg said:

No, hookah molasses are considered tobacco products and are taxed as such. Since hookah molasses contain only small amount of tobacco that has driven driven prices after taxes so high that no one sells them.

Actually I find them readily available.

[jigtg]

As I stated earlier, this proposal is a settlement between big pharma, anti-smoking groups and rest of the industry.
Anti-smoking groups can promote themselves for turning smokers to less dangerous alternatives while doing absolutelly nothing, rest of the industry that pays for the fees see a major boost in their sales as competitors go out of business(and because of sales from China will end) and big pharmas products become more competitive as competition goes down. In short, everyone wins.

[Crossbow]

There are 2 things that to me indicate how 'well' thought through this is...

Logically, a liquid flavoured with tobacco absolute (some of the VS stuff for example) would potentially be a tobacco product, and therefore unaffected (but presumably taxed instead)

And the big one...

Any zero nic liquid is not a NCP, and therefore unaffected, unregulated and ignored.

Or to put it another way - this has everything to do with control, and nothing to do with safety.

[Rusty]

It is Crossbow - I'm more worried when they go for the vaping = smoking thing - which will happen :(

[Kate]

If we can secure consumer regulated nicotine we'll be the first in the world and it will set a precedent. We have a chance because in practice that's what we've actually got at the moment and we just have to argue to keep the status quo. Regulation for safety is included under general consumer protection laws so it would be a non-medical, non-tobacco consumer product - just like caffeine and catnip.

[westcoast2]

The filing from SE/NJOY in SE/NJOY/FDA case is worth reading wrt safety. (at ECF)

The interesting part is 'C. FDA Has Demonstrated No Likelihood of Irreparable Harm to the Public' --> http://www.e-cigaret...ng-now-497.html (Sun Vaporer about half way down). A couple of quotes:

Quote

Although e-cigarettes have been sold since 2007, FDA has not identified a single instance, either in this Court or below, of an adverse health effect from ecigarettes.

Quote

Ultimately, FDA’s case for irreparable harm fails for lack of any evidence that harm is likely at all. If FDA truly feared an imminent and serious threat, it would not have waited more than a year before asserting regulatory jurisdiction

The FDA are due to reply on Monday.

Amongst other things, this restates the point I made earlier, if the MHRA had public health concerns why did they not act earlier?
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[westcoast2]

As well as the FDA reply, this post contains links to the Australin reasoning for their ban and the UK RCP view on nicotine addiction.

The FDA reply is here --> http://www.e-cigaret...tml#post1023951

The FDA seems to be all over the place. They do not seem to be sure if the e-cig is Drug or Tobacco. The safety issue is brought up and they try to dismiss the current testing. Are they admitting the e-cig is safe short term?

Quote

The distribution of these nicotine-delivery devices — which are offered in candy flavors, DET 28 (Docket Entry 15)— thus presents a serious risk of addicting new users, including children. Woodcock Decl. ¶ 5.

Plaintiffs’ paid consultant does "not believe that the results of the [FDA] study demonstrate any significant risk to consumers of e-cigarettes from nicotine poisoning, or exposure to" the other toxins identified in the sampled cartridges. Thomas Decl. ¶ 17.

But the purpose of the sample analysis was not to determine whether plaintiffs’ products are safe. That is the purpose of the scientific studies required to support an application to market a new drug. See 21 U.S.C. § 355. Nor could a court discount the health risks associated with "electronic cigarettes" even if the FDA had identified not a "single instance" of "an adverse health effect" from "electronic cigarettes," (Opp. 17)– although, in fact, short-term side effects including racing pulse, dizziness, slurred speech, mouth ulcers, heartburn, coughing, diarrhea, and sore throat have been reported, see Woodcock Decl. 14.

The long-term health consequences are unknown precisely because "electronic cigarettes" have been subject to so little testing and analysis.

The FDA are concerned that the flavours will be attractive to children, They are also concerned that these 'devices' could addict non-smokers or again children.

This theme of addicting non-users is part of the reasoning Australia used for banning nicotine containing e-cigarettes (see pages 126-143 National Drugs and Posisons Schedule --> http://www.tga.gov.a...rd/rr200810.pdf

Safety didn't count for much in Australia either. Part of their argument is that allowing consumer regulated nicotine on the market is incompatible with the Australin tobacco control policy.

Nicotine dependancy itself is seen as non-benign. This view is expressed by the Royal College of Physicians in "Is Nicotine a drug addiction? --> http://www.rcplondon...4-addiction.htm

Although reading through the RCP document, they seem to equate tobacco use and nicotine use at times.
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Edited by westcoast2, 08 February 2010 - 07:33 PM.

[Ian]

What a load of contrived bull.

On the point of children being attracted to flavours, irrelevant nonsense. I was 9 years old when I started smoking and 12 or 13 when I tried alcohol. There were no flavours to attract me yet I still gave it a try as did many of my mates. Peer pressure, rebellion, doing something reserved for adults - those were the major motivators and still are for kids. As a parent I'd be far happier if my children took up vaping than smoking.

Safety is another red herring, certainly as far as the UK initiative is concerned and based on the US judgement I'm pretty sure their laws in that regard are not much different to ours. The MHRA's remit is to regulate medicines and medical devices. Unless a substance/device is being marketed or represented as medicine, or a near identical product/compound has already been approved, they are on shaky ground at best.

The Dept of Health has authority to act where there is a risk to public health and it can delegate responsibility to the MHRA. However, such risk has to be reasonably proven. Further, in addition to assessing the risk of not taking action they also need to consider the risk of taking action. In the case of vaping, there is no significant quantifiable risk associate with the current market offerings and that is supported by the US judgement. There is, however, easily identified risk associated with the implementing the proposal. Namely, it will force many of those who have adopted vaping in place of cigarettes (the dangers of which are well understood) to return to tobacco in order to satisfy their desire to consume nicotine. There is no way anyone can get an e-cig system approved and into the supply chain in the timescales associated with the preferred option 1. The attempt at risk assessment as covered by the proposal document is a joke.

[prof beard]

Ian said:

The MHRA's remit is to regulate medicines and medical devices. Unless a substance/device is being marketed or represented as medicine, or a near identical product/compound has already been approved, they are on shaky ground at best.

The Dept of Health has authority to act where there is a risk to public health and it can delegate responsibility to the MHRA. However, such risk has to be reasonably proven. Further, in addition to assessing the risk of not taking action they also need to consider the risk of taking action. In the case of vaping, there is no significant quantifiable risk associate with the current market offerings and that is supported by the US judgement. There is, however, easily identified risk associated with the implementing the proposal. Namely, it will force many of those who have adopted vaping in place of cigarettes (the dangers of which are well understood) to return to tobacco in order to satisfy their desire to consume nicotine. There is no way anyone can get an e-cig system approved and into the supply chain in the timescales associated with the preferred option 1. The attempt at risk assessment as covered by the proposal document is a joke.

Very well put - my own response focuses very much on these aspects and is being carefully crafted and presented from my professional (researcher and senior manager who works in a - unrelated - field that involves dealing with innovations) viewpoint.

[Ian]

I just found this articleregarding the FDA appealing the earlier district court ruling. I particularly like the mention of the FDA having approved nicotine lollipops as legitmate NRT. How does that fit with their concerns about making nicotine attractive to kids?

[Ian]

prof beard said:

Very well put - my own response focuses very much on these aspects and is being carefully crafted and presented from my professional (researcher and senior manager who works in a - unrelated - field that involves dealing with innovations) viewpoint.

I don't know if you caught it, but I posted a link a few days ago to a government policy document that lays out the behavioral responsibilities of regulating agencies generally. You might find it helpful.

[BigSpenda]

Ian said:

Where do we stand with understanding the legal aspects of this? The more I think about it the more I begin to wonder if legal challenge is the only effective way to fight this. Let's be realistic, the powers that be have made up their mind and the chances of us forcing them to change it purely through democratic lobbying is remote. However, there is the question of whether they have the legal right to do this. Somewhere there must be statute that clearly defines the scope and remit of the MHRA and reading the MHRA's own website it would clearly suggest that their remit does not extend to vaping any more than it does to cigarettes. The only reason they have jurisdiction over NRT is because that is clearly marketed as a treatment. So, what gives them the right to overstep their bounds? A request from the department of health is all they have at the moment as far as I can tell. Speaking purely as a layman admittedly, I don't believe that is enough to count as a statutory instrument or enhancement to existing legislation. The question is, who is going to challenge them under the law?

THANK YOU IAN!

Apparently, nobody could be arsed to plough through the post I wrote this morn, which covers 9/10ths of what has been said here. :frown:

I completely agree Ian. There are grounds for a class-action suit -- possibly more than one. I can see anti-trust litigation, on the part of vendors, against the monopolisation of the nicotine-products industry. I can also see civil-liberties litigation, on the part of consumers, who are adults, and are free to make our own choices, without excessive interference. I am not well versed in the law, let alone UK civil law, but breaking monopolies down has been the trend, since Thatcher. (There are a few things that should be government owned monopolies, and aren't any more...) I should think the time has come, for the team of barristers and solicitors to be assembled.

In the post (which is not even all that long), which nobody seems to have read, I made a specific request of all the Vendors, to provide me with some info, so I can write up something by way of a letter/press release/counter-proposal/argument, in which I create a 'third way' of looking at personal vapour inhalation devices, which is neither 'smoking', nor 'medical'. That has been my position all along, and I keep seeing it peek through, particularly Kate and Westcoast have got the idea, and then we're back on the subject of 'smoking alternatives'. I refuse to give up on changing the whole perception of vaping, away from and unrelated to smoking, and not a medical product. Vaping overlaps in some ways with both, but it is a NEW leisure activity, and does not fall into any pre-existing category. I've been working on this document for much of today. I need some info from vendors, to make it substantive, and not just my point of view.

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Bravo WestCoast, Language DOES matter! Can we come up with a noun for the hardware? Something which contains neither the word 'cigarette' nor the word 'nicotine' would be ideal. I've submitted my idea. It's in the thread where Andy asked for one-sentence statements about vaping. It's an idea. It's a ball to toss around. One word, or two, at most, would be good. Personal vapouriser isn't bad, but it isn't clear, and it isn't 'catchy'.

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I must say, it's rather discouraging to read all these pages of you lots' posts, and know I just said the same bloody thing, in another thread, only a few hours earlier. If I thanked you in this thread, chances are, unless you're Professor Beard, I mean 'I said that, too, how nice that we agree'. Maybe I should keep my posts short and punchy, for people with the attention-spans of Yanks?

Yes, I am grumpy. I am not at all well, and stressed the fxxk out. I've just discoverd, by trying to read something there, that I've been banned from the TW Forum. I reckon Pillock38 took issue with some things I said about him in places where he is not in control. I find that mighty high-handed, but he'll get his, one of these days, no doubt. In any case, if somebody would care to fill me in on what exactly was said there, that so depressed people, I would appreciate it.

I'll post this and keep on reading. I owe several of you a serious smack, and I'm just saying so now. I have no intention of flaming. I am personally very hurt, upset, and angered by an attitude, about which I have already complained once. That's for after. If I can keep awake long enough to read this whole thread, that is...

Tired, running a temp of 41, not happy with the headless chickening I'm seeing. This needs to be an Organised Movement. I know how to do that, but I don't know the Major Players. It is frustrating as hell to be a leader type, who can't lead, because everyone is too busy trailing off in different directions, and every so often Kate shouts 'we're all in this together', and everyone agrees, until six posts later... It's like herding cats. I think Kate said that, and now I see what she meant. Good one Kate!

Very crossly, and you ain't heard nothing yet...:mumbles:

Uma