59 replies to this topic

[trog100]

Quote

Off course i will work with the MHRA to make sure any diseased person entering my sites are directed to nicorette or relevant NRT or quit smoking help lines..

"any diseased person entering my sites"... a poor choice of words sounds too much like foot and mouth restrictions... he he

use some nicer sounding ones that mean the same thing..

trog

[Jackie]

It definitely conjures that image doesn't it Trog. LOL

[ecigsoutlet]

Put it on my site with (very) slightly different wording and punctuation. Added a link to NHS smokefree (good idea ?)

Quote

WARNING: the electronic cigarette will not cure a smokers addiction to nicotine. The electronic cigarette serves the same purpose as a tobacco cigarette, it delivers its user nicotine. If you do suffer from Tobacco / Nicotine Dependence Syndrome and want to take steps to give up smoking or cut down the quantity of cigarettes you currently smoke we recommend you visit your health care provider to discuss NRT (Nicotine Replacement Therapy) or a nicotine harm reduction programme.
NHS Smokefree
Please Note: We are not a pharmaceutical company and we do not produce or sell medical products. Our products are for recreational purposes only.

I've looked through my kits and where there are references to quitting (not all kits) its only on one page. I'm going to cover the page with a "Recreational Use Only " sticker.

I wish I was as sure as Jason seems to be that this is going to work but I can see no harm.

I've always thought we were not supposed to market as NRT from the word go anyway, so I've not had to make drastic changes.

Lee

Edited by ecigsoutlet, 19 February 2010 - 07:57 PM.

[Kate]

If you're going to claim to deliver nicotine you'll need proof, Eissenberg's study will bring that into question without doubt.

[Crossbow]

Or you can claim it is intended to deliver nicotine, and be covered either way. I'm not convinced his study has much merit, tbh, it was a very artificial and non standard useage pattern.
Either way, it's a point thats still open to debate.

[Toby]

I know you keep on about the Dr Eissenberg study, but as I think you've said yourself, he does have contradictory findings; and it does appear that his studies are at least partial or total BS, presumably not carried out in a scientific enough way (maybe he just didn't get them to suck hard enough! ..lol..).

Yes, of course I know that e-cigs are no where near as effective at intake of nicotine as cigarettes. But why would you need to prove it, that at least some quantity of nicotine is being taken into the body? Assuming of course that there is nicotine in the liquid, and therefore the vapour.

[Kate]

Say what you want but if you have no proof you'll be acting against the guidelines of the Advertising Standards Authority.

Why make any claims? What's the point? It's obvious that if you really sell nicotine and people make vapour with it then they might be getting it delivered to their bloodstream.

I don't see why making a meal of it is so important, just don't make any unproven claims and you won't get into any arguments.

[Ralph]

It appears that 99.99% of the population of this planet suffer from DSRNRDS - drugs, sex rock&roll dependency syndrome. Possibly the term is not inclusive of all diseased dependencies such as the hyperventilation involved in a fast walk in the country.
Obviouslöy the diseased indivividuals who indulge in sexual intercourse purely for pleasure are addicts to endomorphs and anyone who enjoys a beer is self medicating.
We are obviously poor uneducated creatures who need to sacrifice our pleasures to the all knowing drug companies who will enevitably cure us of the worst disease - being alive. Life is, after all the sole common denominator to illness.

[pillbox38]

Ted>>.Im not adding tobacco dependence syndrome for nothing other than the correct reasons..

"tobacco dependence syndrome has been classified as a disease in the International classification of diseases (ICD)"

Pg 10 Eu orientation note Electronic cigarettes and EC Legislation Brussels 22-05-2008


Remember its the MHRA and i dont sell a medicine, MLX364 and the MHRA deal with disease,disease cures and medicines.. They like this terminology...

[Ochso Kube]

Im really sorry, it is, im sure, due to tiredness.

1. We are writing to consult you on whether to bring all nicotine containing products (NCPs) – with the exception of tobacco and tobacco products - within the medicines licensing regime, which would require all currently unlicensed NCPs on the market, such as electronic cigarettes containing nicotine and nicotine gels, to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a medicines marketing authorisation (MA).

Doesnt that statement of intent mean all.?

also

Could nicotine be classed as a tobacco product? as it is produced from the tobacco leaf. - full circles spring to mind? regarding the FDA.

Im no doubt, hopefully, wrong.

[jigtg]

So NRT products are currently unlicensed in the UK?

Here are some comments on the text:
NRT products can be used to cure smokers addiction to nicotine(which is what they are intended to do) but can be used to become addicted to nicotine(which is what they are not intended to do). Electronic cigarettes can be used as alternative to cigarettes(which is what they are intended to do) but can also be used to cure smokers addiction to nicotine(which is what they are not intended to do).
Not all e-cigs deliver nic. Some e-cigs could be sold as NRT.
There are tobacco products that do not contain nicotine yet they are still tobacco products.
-->
"WARNING: the electronic cigarette product we sell are not intended to cure a smokers addiction to nicotine, such as different tobacco products can deliver different amounts of nicotine to its users, different electronic cigarettes can."

Can be cured without products as well.
What is "nicotine harm reduction programme" supposed to mean?
If you continue the intended reasoning...
-->
"If you do suffer from the disease of Tobacco/Nicotine Dependence Syndrome we recommend that you visit your health care provider to discuss about different methods and products, such as NRT(Nicotine Replacement Therapy), that are intended to cure this disease."

[trog100]

pillbox38 said:

Ted>>.Im not adding tobacco dependence syndrome for nothing other than the correct reasons..

"tobacco dependence syndrome has been classified as a disease in the International classification of diseases (ICD)"

Pg 10 Eu orientation note Electronic cigarettes and EC Legislation Brussels 22-05-2008


Remember its the MHRA and i dont sell a medicine, MLX364 and the MHRA deal with disease,disease cures and medicines.. They like this terminology...

its what happens when you read all the legal stuff jason.. the wording "diseased person" to the average reader does conjure up images an infectious plague carrier.. :)

it might be offensive to some.. its a wee bit like calling a disabled person a cripple or a spastic.. literally true but now considered offensive and insulting..

i am sure its possible to cover your tracks and write legal disclaimers more politely.. lets not forget what you have been reading is not aimed at normal human beings..

two examples of the same thing.. both mean exactly the same thing.. one sounds very offensive one dosnt..

example one... a diseased person..

example two.. a person suffering from an illness..

just my thoughts..

Ted

Edited by trog100, 20 February 2010 - 01:35 PM.

[Ian]

I'm not sure if this will confuse people more or help clarify some aspects of how medicines regulation traditionally works but here goes.......

A nicotine patch on its own is not NRT, nor is nicotine gum, lozenges or the inhalator. They are only a component part of it. They don't become a treatment until combined with the prescribed usage and when used to achieve a clearly specified medicinal response. The instructions you get on a box of patches or even a box of lemsip are a fundamental part of the overall treatment - the active ingredients are only one component of that overall treatment. When a company applies to the MHRA (or the FDA or pretty much any of their counterparts around the globe) they do not just say "we've got a compound we want to sell as medicine". They have to say exactly how the medicine will be used, exactly what conditions it is meant to treat, and to what extent it will help those conditions. Until all those aspects have been ironed out and agreed with the regulator they won't even get approval to start clinical trials.

The point is it is not purely the nicontine that makes the current NRT products medicinal products and the fact that they contain nicotine does not immediately make all other products that contain nicotine medicines. Nitroglycerine is used in some heart treatments, but that doesn't mean dynamite manufacturers need an MA from the MHRA.

The fact that the MHRA wish to think otherwise does not make them right. Unfortunately the fact that they are wrong doesn't mean they will lose.

[trog100]

i think too may words lose the meaning ian..

i see two factors one is nicotone.. the substance..

two is the intended or claimed use or purpose.. two being more important than one..

no one is going to claim dynamite is intended to cure something.. jason is just trying to put e cigs in the same camp.. sadly its part true part not true..

all sorts of e cig positives have to be gotten rid of.. life saving lives..

still a stance has to be taken..

trog

[Starlight]

trog100 said:

the wording "diseased person" to the average reader does conjure up images an infectious plague carrier..

As a disabled person myself, I tend to agree with Trog... As a smoker, it was bad enough often being made to feel as if I was an outcast with leprosy. So for smokers to be referred to as "diseased" does seem to imply that not only is it an illness but a contagious one.

Regardless of whether the ICD wish to further stigmatise smokers by officially referring to them as "diseased", what if one phrased it as a "condition" one "has" rather than a "disease" one "suffers" from?

[hifistud]

Ochso Kube said:

Im really sorry, it is, im sure, due to tiredness.

1. We are writing to consult you on whether to bring all nicotine containing products (NCPs) – with the exception of tobacco and tobacco products - within the medicines licensing regime, which would require all currently unlicensed NCPs on the market, such as electronic cigarettes containing nicotine and nicotine gels, to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a medicines marketing authorisation (MA).

Doesnt that statement of intent mean all.?

also

Could nicotine be classed as a tobacco product? as it is produced from the tobacco leaf. - full circles spring to mind? regarding the FDA.

Im no doubt, hopefully, wrong.

No, I think you've probably hit the nail on the head. What the MHRA hasn't considered, though, is Nicotine pesticides - this thought has literally only just occurred to me. I'm pretty sure they still legal (with a max concentration of 4% nicotine).

The MHRA has used the change in WHO and DoH attitude towards Tobacco Harm Reduction to propose bringing under their aegis products which make no medicinal claims but can be used to lessen the smoking of tobacco products. Again, it has nothing to do with intent or claim, but function and delivery.

Unfortunately, unless all manufacturers adhere to the same labelling and statements of intent, one bad penny gets everyone tarred with the same brush, IMHO, so I'm less than 100% convinced that this new disclaimer will serve its purpose. I can see exactly what the theory is, and if we got 100% compliance from all UK vendors, it might just work, but with the one black sheep already bending over and waiting for insertion...

[Kate]

My understanding is that the Poisons Act 1972 covers nicotine products, including pesticides up to 7.5% without license. Presumably the MHRA will have to remove nicotine from the provisions of that act if they want full control of it ... maybe. ??

It's very easy with claims - do not make any unless you have uncontested proof. Even mentioning disease or illness in relation to a product you sell could be a problem.

Linking hardware with nicotine by name or claim might also prove to be a mistake, if nicotine goes down then the linked hardware goes with it.

[trog100]

i have big ethics problems here.. i use the product i sell because of health reasons.. the customers i care about have health problems.. they tell me so and thank me for helping them..

they tell me.. i dont tell them..

interestingly are we saying all these "diseased" people should tell lies to get their e cigs.. the only reason for long term smokers to be killing themselves with tobacco is because they are "diseased" people.. ether that or very stupid people

i dont take the view that simply because something is perceived to be healthier or safer than something else it has to be a medicine..

over eating is a "disease".. that dosnt make fat free food a bloody medicine..

we do live in a world of perceptions by the way.. there is no "truth" simply what we perceive.. if the police can talk about "perceived crime" i think we can use the same mendacity...

we are moving into the dangerous world of totalitarianism here.. when you are forced to tell lies to do something you should be able to freely do its wrong.. i am a diseased person.. by their definitions anyway..

how i handle my "disease" is my business and my business alone.. which is how it should be...

they have no valid reason to want to medicalise e cigs.. their premise is flawed.. we should fight them on that basis.. not wriggle to one side and try and pretend when they do it wont apply to us..

trog

[hifistud]

Quote

they have no valid reason to want to medicalise e cigs.. their premise is flawed.. we should fight them on that basis.. not wriggle to one side and try and pretend when they do it wont apply to us..

Quite.

[Kate]

Marketing claims are regulated, if you make any you'll be liable to prove what you say. If you're not selling you can say whatever you like. As soon as traders make health statements the MHRA is obliged to make sure they're correct and the related products are regulated properly. In theory if you don't make unproven, unregulated health statements then they can't touch you.

Edited by Kate, 21 February 2010 - 12:01 AM.