255 replies to this topic

[prof beard]

Kate said:

As an adult UK citizen I believe I should have access to properly regulated nicotine liquid up to 7.5% (that's the limit set by the Poisons Act) without being labelled as a junkie or patient.

I don't have to have a prescription to buy and drink caffeine and the higher concentration of toxicity of nicotine simply means more careful regulation, not a ban or unreasonable restriction of my habit.

Vaping is a habit apart and we have got to sell it that way. The fact that it helps people quit smoking is secondary to the fact that they have simply swapped habits, not been cured.

In an ideal world I would agree with you but the evidence is overwhelming that the reason people have swapped habits is to stop smoking...

I agree it is NOT about being "cured" but to claim it is not about avoiding smoking is disingenuous and will be seen as such I think. I couldn't stand up in court and swear the reason I tried vaping was just to see what it was like...

[smokindeuce]

Ian said:

For me, that's not much more attractive than an outright ban. I'm pretty sure any regulation would likely put an end to loose juice and refilling our own carts. That on it's own puts ecigs not far off analogs in terms of cost. Add on taxation and you pretty much kill off any cost benefits, perhaps even make it a more expensive option. For some, the health benefits would be worth the premium but for many, especially those who have yet to dip their toes in the water, it would be a complete turn-off.

Yes you're right, but I still personally prefer this category to the Pharma route.... I mean at least there would still be a decent market competition to keep prices as low as possible.

[Ian]

Kate said:

There are monopoly issues here as well as improper regulation of a recreational substance. Why would a capitalist society want to cut out innovative product development, price competition and freedom from the harm of smoking for millions?

You could use that argument to question the current regulation of the entire pharmaceutical and healthcare industry. We live in the real capitalist world where self-interest and corruption rule unfortunately and protectionism trumps the common good every time.

[Jackie]

Kate said:

Vaping is a habit apart and we have got to sell it that way. The fact that it helps people quit smoking is secondary to the fact that they have simply swapped habits, not been cured.

I agree completely, however if we don't mention that it's helped us to quit also that's got to be telling a lie that would be easily uncovered as the Prof says.

I haven't figured out the right way to word a response yet, I'm just thinking out loud. :)

[Kate]

Yea, it's important that we've SWAPPED and are doing less harm but keep in mind the point is to control what we're allowed to do and we have got to have better arguments than cessation - that is just not enough and needs to be backed up with insistence that we are fully able to choose our own poison.

[Jackie]

I'm with you Kate. :)

So saying something like 'E-cigarettes have helped me to replace my smoking habit with a safer alternative - vaping' is telling the truth in my mind but also highlights that I haven't 'quit' smoking but am just using a better replacement?

[smokindeuce]

Jackie said:

I agree completely, however if we don't mention that it's helped us to quit also that's got to be telling a lie that would be easily uncovered as the Prof says.

I haven't figured out the right way to word a response yet, I'm just thinking out loud. :)

The route to using a PV can be seen as 'quitting cigarettes' or alternatively 'seeking another alternative.'.... depends whether you're glass is half full or 3/4 full. :)


DOOH: beaten to it lol

Edited by smokindeuce, 01 February 2010 - 11:16 PM.

[prof beard]

Kate - there is an important point there - vaping is EMPOWERING - hence my "responsible nicotine use" point. We can CHOOSE to continue to use nicotine (or not) and enjoy it (either way) without doing significant harm to ourselves or others. It's about the responsible exercising of freedom...

[Jackie]

Well, I shall sleep on this and try to consider carefully my response to the consultation.

We should probably also keep in mind that there are others vapers out there who are a) unaware so far, b) don't care (I've seen a few of those already) and c) think along entirely different lines. I mean, just because we (or the more vocal among us at least) don't want them to be classed as NRT or quit smoking devices doesn't mean that everybody else thinks the same. So I doubt not having the absolute correct wording will do masses of harm, not sending a response at all certainly will not help though.

That said, it helps to get things right from the start so all discussion is good in my book. :)

[prof beard]

I also think that the more individual each response is the better. We may want to have a generally shared view but variation is good and also real...

[smokindeuce]

I guess everyone will see this differently, but the main thing in moving forward is that we agree on the basics which I think have already been covered.

The ecig in it's current form will get nowhere if we make debatable cessation claims... all this will mean is someone, somewhere will have to get off their bureaucratic backside and look at the liquid/devices very closely (even take them off the market to perform trials), and then if/when approved for 'cessation', slap NRT across the packaging and make them prescription only. If they're not approved an outright ban.

Am I missing something or...?

[Kate]

prof beard said:

Kate - there is an important point there - vaping is EMPOWERING - hence my "responsible nicotine use" point. We can CHOOSE to continue to use nicotine (or not) and enjoy it (either way) without doing significant harm to ourselves or others. It's about the responsible exercising of freedom...

Yes, I think we're on the same page with that Prof. What's important is that we are allowed to choose, absolutely. Making informed choices is one of the bedrocks of democracy and any removal of choice should only be allowed under extreme circumstances when people are unable to make informed decisions for themselves. Liberty is eroded each time the state takes away a choice 'for the good of the children' or 'for our own good'. We're being infantilised.

Back to the NRT argument - if we say we've quit or have been cured they will say we are using medical products and should only use the ones they approve. If we say we get our nicotine in less harmful ways and would prefer it to be done legally and as safely as possible we might have a better case. Maybe.

[smokindeuce]

Kate said:

If we say we get our nicotine in less harmful ways and would prefer it to be done legally and as safely as possible we might have a better case. Maybe.

Agreed.... :) and a big 'maybe'....fingers crossed!

[westcoast2]

Quote

In an ideal world I would agree with you but the evidence is overwhelming that the reason people have swapped habits is to stop smoking...

I agree it is NOT about being "cured" but to claim it is not about avoiding smoking is disingenuous and will be seen as such I think. I couldn't stand up in court and swear the reason I tried vaping was just to see what it was like...

This is where I am out of step. I could stand up in court and say just that. It is also an alternative to be used where tobacco smoking is not available.

As to being disingenuous, if some have quit then fine. This can be highlighted. Many have said they 'accidently quit' or wanted to quit cigarettes (not necessarily nicotine).

The question is, do you want it's primary purpose to be NRT or recreational. From what I have gathered, correct me if I am wrong, so far it is recreational. Quitting cigarattes and a medical treatment for quitting are different, There is a need to consider the distinction before choice disappears. Languaging is important here.
-----

[hifistud]

Jackie said:

I plan to personally respond as well. Maybe we could get more people doing that if we had some kind of 'form' letter(s) for people to use? In my experience the least effort required the more participation is likely. :)

I'm not the person to do it however, I'm fairly good with words but not brilliant where this kind of thing is concerned.

Emphatically not a form letter - they will be disregarded or lumped together as one response. Individually worded responses cannot be disregarded in such a cavalier fashion.

[hifistud]

Some pointers:

From the MHRA Consultation letter: "While the risks to health from smoking tobacco are well established, a body of evidence is emerging that suggests that nicotine, while addictive, is actually a very safe drug."

"There is a growing body of evidence that supports a harm reduction approach to nicotine addiction and for several years there has been a call for a process by which an individual limits, to the greatest extent possible, the risks to their health and the health of others by reducing or ideally eliminating exposure to tobacco smoke. The most recent (January 2009) is from the BMA Board of Science which has produced a policy position entitled ‘Harm reduction a tobacco free approach supporting those smokers struggling to quit’. They consider that, in terms of harm reduction, effective alternatives need to be considered that allow an individual to obtain nicotine without being subjected to the risks of smoked tobacco"

"We understand there are around 24 manufacturers that produce unlicensed NCPs that are distributed by around 80 distributors in the UK. We have estimated that there are around 100 unlicensed NCPs that are distributed in the UK and we have assumed that 50% of
22
manufacturers will go through the process of licensing their products, resulting in the licensing of about 50 products. We would therefore expect to receive 50 applications for MAs at an estimated one-off cost to industry of £1.439 million. This includes the manufacturer’s licence, which currently attracts a fee of £3027."

On this last one - aside from Trog and GD, I am not aware of anyone making hardware in the UK - it would seem, though, that juice manufacturers would be caught by this.

If this goes ahead - and it seems to me very likely that it will - there'll be 21 days after June 1st this year before just about every e-cig and juice has to be pulled. The third option - do nothing "warrants no further investigation as it is neither in the public health interest nor commercial interest to leave the current regulation of NCP/NRT untouched." - so any replies supporting it will be ignored. In effect, we're being limited to options 1 and 2.

The likelihood of regulation on e-cigs and e-liquid is close to 1, and it looks as though HMG has chosen MHRA to shoulder the responsibility. There is no scope in any of its consultative documents for a separate regulatory agency - neither is there any scope for a "do nothing" approach, although that should not preclude any of us from expresing a desire to see e-cigs left as a habit unregulated by MHRA. If that is to be at all, it will be with BP grade Glycerine or PG - it looks as though the hardware will nat necessarily fall under MHRA's regulatory guidelines, although anything resembling a "toy" cigarette will be caught by the policy document - as, indeed, anything resembling a cigarette (ie white battery and brown cart, red LED) will also be caught by both sets of documents, whereas large battery mods that do not resemble cigs might escape.

It's also interesting to note who HMG considers to be manufacturers in its distribution list, and what they actually manufacture.

But, it's late, and I need kip. There are troubling times ahead.

[Kate]

I'm going to be arguing for option 3 on the grounds that MHRA should do nothing because nicotine is not a medicine. If they do regulate then the chances are that my health will deteriorate.

This is a classic case of breaking something that doesn't need fixing and they're going to kill people by making this product as inaccessible as they can.

There'll be no incentive for innovation with nicotine products either if pharm and tobacco companies can corner the market and keep small businesses unable to afford a slice of the pie.

[S3AB1SCU1T]

Concupiscible said:

On second thoughts... what we really need is for Apple to make an e-cig. That way we'd have public support in the bag... they'll buy 'em in droves.

I think your right. a big coperation with a hell of a lot of money to back em up because at the end of the day thats what talks.
and it also gives me an excuse to pull this old chestnut out too :lol:
http://ukvapers.com/...d=1&pictureid=3

[Kate]

[ame][/ame]

[hifistud]

I've drafted this up to answer some specific points raised in the consultation document. Obviously, this is only a draft, and I have every intention of revisiting it a few times before I finally reply to the consultation.

Quote

Regulation by function:

If the function of providing nicotine as a drug is considered, then, by definition, this must include the smoking of tobacco.Topical and oral delivery vary greatly from the use of electronic cigarettes, but in all cases, users will self titrate - that is, once their plasma nicotine levels are "satisfactory" they will cease administration, and will use whichever delivery system again when levels drop below their personal threshold. This speaks to the sub-heading of "Efficacy".

Many users of electronic cigarettes do not consider themselves to be self-medicating, nor using electronic cigarettes in a therapeutic manner, but simply to have switched to a habit similar to smoking, but many times safer, not only for themselves, but also for those around them. Many are people who would not consider currently licensed NRT, as they have no desire to quit smoking, but, at the same time, wish to rid themselves of the major risks of smoking tobacco - risks presented not by nicotine, but by everything else that burned tobacco contains.


Safety

In assessing the safety of, specifically, electronic cigarettes, the MHRA's own documentation, together with the government's policy document, the phrase "a body of evidence is emerging that suggests that nicotine, while addictive, is actually a very safe drug" is used. I have no argument with that statement. Electronic cigarettes have been available worldwide for some three to four years now, and thus far there are no documented cases of anyone suffering any ill effects from them.

As an alternative to smoking tobacco, Dr. Murray Laugesen has completed research that shows that the safety level of electronic cigarettes is "several orders of magnitude (100 to 1000 times) less dangerous than smoking tobacco cigarettes"

Electronic cigarettes produce no secondhand smoke - there is no passive smoking with them, so public safety is also several orders of magnitude better than with traditional tobacco smoking.

To, once more, quote Dr. Laugesen "E-cigarettes are cigarette substitutes. If they can take nicotine market share from cigarettes, and that is the big question, they will improve smoker and population health. "

Withdrawal from the market under process of MA stands every chance of reversing the trend towards electronic cigarettes taking the nicotine market share from cigarettes. For this reason, Option 1 should not be considered and Option 2 is highly questionable.



Quality

Over 75% of the supply of the liquid used in electronic cigarettes is manufactured in China by Dekang (also known as Boge and Ecis), and is rebranded by distributors and resellers, or sold under the Dekang brand. It is also the liquid tested recently in the USA and found to be free of the carcinogenic TSNs and the liquid used in the Ruyan V8 which Dr Laugesen used for his testing.

In over three years of availability for electronic cigarettes, there have been no recorded cases of ill-effects from any nicotine liquids. Smokers choosing to switch to electronic cigarettes, therefore, are choosing to move to a much safer, and, one could propose, better quality alternative to smoking tobacco. Surely this should be encouraged, not discouraged by subjecting this acceptable alternative to regulation as a medicinal product.


Efficacy

Since tolerance to and dependence on nicotine both vary from person to person, judging the efficacy of any nicotine delivery method on a release rate on a per second or minute basis bears no relation to the reality of usage. Smokers and users of currently licensed NRT as well as NCPs (and particularly electronic cigarettes) self titrate. It has been demonstrated, for instance, that smokers who switched to low nicotine yield cigarettes simply smoked more of them in order to bring their blood nicotine levels to their "satisfactory" value. A user of nicotine lozenges, when presented with a lozenge of half the dosage that s/he is used to will, quite simply, use twice as many (unless a quit effort is being undertaken).

Thus, the efficacy of current unlicensed NCPs is almost entirely dependent upon the individual - for instance, a lower concentration of nicotine in an electronic cigarette cartridge will simply accelerate the next usage, while a higher concentration cartridge will be used for a shorter length of time.

Impact Assessment.

I am unclear as to which UK manufacturers of electronic cigarettes and their associated liquids the IA section of the document refers. However, aside from only two hardware manufacturers, I know of only two UK based liquid manufacturers, both of whom, I believe, have their liquids prepared in laboratories already producing licensed NRT. The current market is small, and a fee of over £28,000 for obtaining approval would, it seems to me, to be only the tip of the iceberg. These products are demonstrably very much safer than smoking tobacco, are generally not used medicinally, and indeed, could be compared to caffeine bearing products like coffee, soft drinks and so on rather than medicines.

It seems inappropriate to subject them to regulation as medicines when they are primarily used as an alternative to smoking tobacco, and not as a therapy to aid a quit attempt. As such, they serve the very useful purpose of contributing towards a Smoke-Free Britain, but removal from the market pending approvals would, in effect, condemn users to returning to smoked tobacco, as the vast majority would not consider currently licensed NRT, bearing in mind they have chosen to switch, not to quit. That many have ceased smoked tobacco usage is an accidental by-product of their electronic cigarette usage.

Edited by SubVap, 02 February 2010 - 02:15 PM.