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Thread: UK regulation -- Discussion thread

  1. #21
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    I agree Chrissie,

    I have posted a link to rolygate's report on a few fora and facebook groups and very little response their either except on UKV and VN

  2. #22
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    @Chrissie
    There are two things that people can definitely help with:

    1. Nobody much in the UK has heard about ecigs - you will often meet people who don't have a clue what you're talking about. We need to change that. At first sight it looks hard for the individual to do much, but the internet has changed that. For example you can go to UK-based blogs and leave a comment somehow; write to the editor of your local paper; write a letter to the paper; go to major newspaper sites and leave a comment; write to your local TV network; or write your local radio station. Leave some publicity materials wherever you can; and write to and phone your MP. It's up to people to fight for their rights or they may be taken away. Get a T-shirt printed with a suitable message and wear it (we're working on this).

    2. Phone and write and email any supplier you see making any kind of health claim and point them to these threads. Don't let them get away with it. Tell them if they make health claims then ecigarettes may be classified as medicine and in effect banned. If you make health claims for a product it comes under medical licensing law.

    Don't you ever wonder why vitamin pills and so on never mention any kind of health effects they might have, now? They all used to, I remember that time... It's because if they do so now, they need a pharmaceutical license - real-world cost from £100k upward.

    So there are things you can do. Most of them involve some legwork. It's up to the individual how much they value their freedom.

    At ECF we're going to get various publicity materials organised, such as A4 flyers and so forth. But nothing is much use unless people fight for their rights.
    Last edited by rolygate; 06-08-2010 at 12:28 PM.

  3. #23
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    Quote Originally Posted by rolygate View Post

    “It is totally unacceptable that as things stand, children are able to legally purchase electronic cigarettes exposing them to high concentrations of nicotine.
    Unfortunately not the case. Hire someone who knows what they are talking about and/or stop giving important tasks to school leavers.
    As lovely as it would be if your riposte were accurate, sadly, it isn't. There is no UK law preventing minors from purchasing what the MHRA refers to as NCPs, and, because of advice from various bodies, the MHRA has altered the MA status of NRT itself now to include indications for use in "children" who "need" to be weaned off cigarettes.

    Quite what anyone means by "high concentrations" of nicotine is anyone's guess.

    And if I may, I feel, quite strongly, that the LACORS press release gaffe is a red herring. We should not let it divert our attention from the real threat, which is more to do with the MHRA (with EU complicity) using the second limb of qualification for bringing e-cigs under the umbrella of medicines.

    Asking retailers to avoid making any health claims, when Intellicig is doing precisely that and working towards an MA, is very much a case of bolting one half of the stable door when the horse has bolted. Trading Standards and other bodies already have documented instances of web sites making health claims, and one (which I believe came out in particular) with a phased withdrawal from nicotine plan - their quit packs.

    There is, I feel, a much greater prospect of success if we attack the second limb approach the MHRA has taken, for, in so doing, they absolutely must consider all nicotine containing products, with no exceptions, unless they can provide plasma level boundaries that define physiological or pharmacological effect.

    This has now become a political battle - the most important people to educate are the MPs, because it's through Parliament that we stand the best chance of getting the whole thing thrown out. The MHRA is empire building, but the new Health ministers have yet to set policy in full - and they will bend to pressure from their parliamentary colleagues.

    Yes, publicity and awareness campaigns are a superb tool, but simple awareness will not win the day, unless and until the number of UK e-cig users achieves critical mass, which, sadly, it has yet to do.

  4. #24
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    Quote Originally Posted by Chrissie View Post
    LOL Katherine, I so wish I did have front page access to the main newspapers

    At the moment, I'm concerned at how little response there is from other UK vapers to this thread (present company excepted )
    It does'nt concern or surprise me Chrissie. This is now a USA majority Forum so most posts concerning the UK are largely ignored as their is little or nothing US members can do to help us fight our particular battle (even though it is the same enemy). UK vapers have been designated their own little sub-forum (as have Australia, Canada and South Africa) where not many US members look as they have very little interest in them. In fact the UK forum holds very little interest for me and i live in the UK.

    Another point i'd like to make is that i don't think it is a very good idea to post our plans to combat GKS (who fund both the MHRA and the FDA) as they are reading the words we type and therefore are always a step in front of us. This has been obvious in a couple of moves they have made.

    When it comes to Politicians unfortunately they all have their Snouts in the same Trough as the aformentioned Agencies and GSK pay better kickbacks than we Vapers can ever do.
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    Quote Originally Posted by hifistud View Post
    There is, I feel, a much greater prospect of success if we attack the second limb approach the MHRA has taken, for, in so doing, they absolutely must consider all nicotine containing products, with no exceptions, unless they can provide plasma level boundaries that define physiological or pharmacological effect.

    .
    That is the reality, the second limb holds the key and nothingelse. From virtually day one i recognised this but it appears nooneelse sees its validity,.

    Include cigarettes or scrap MLX 364.

    katie Welch told me everyone failed to pin the MHRA bods down on this, i was in the USA or i would have been like a Jack Russell with a rat between my teeth asking this question till i got a satisfactory reply. Ie what legal advice stated Tobacco can be classed as none nicotine containing??

    The MHRA have never answered this question... Reason they haven t?? Because there is no legal advice that says a cigarette is not an NCP.

    We should be going for a dual NCP policy IE NCPs recreational>> I sell these and NCPs medicinal>>>Nicorette sell these.


    I will fight my corner on this point so will both my companies.. Harm reduction, harm management,,.. not for TW or TECC.

    Ban all NCPs or scrap MLX364..

    End of story in my mind..
    Last edited by pillbox38; 06-08-2010 at 08:50 AM.

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    hifistud, Rolygate understands the legal position re. minors currently being able to purchase e-cigs. His criticism was regarding the "high concentrations" statement.

  7. #27
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    This document was requested by the numpties at the MHRA.. I then got stonewalled.

    Our barrister will be retained to press this policy in court if neccessary..

    See Below

    .................................................. .................................................. .....................

    Case Proposal for the Management of Electronic Cigarettes inside and outside of MHRA Regulation

    Executive Summary
    Whilst outside of the scope of MHRA Document MLX 364, there has been an oversight regarding the use of electronic cigarettes as a viable recreational alternative to conventional cigarettes.
    Due to the fact that the nicotine added to the liquid used in electronic cigarettes is derived from tobacco, this means that these products are within the scope of Article 1, item 1, of the EU Directive on tobacco containing products (2) and it is also possible that they could be regarded as such.
    By formally categorising electronic cigarettes as either a Recreational Nicotine Containing Product (NCP-R) or Therapeutic Nicotine Containing Product (NCP-T), where the latter will require a MHRA-issued Medicinal Product Licence, ambiguity as to the intended use of these products can be removed and controlled via a two-tier regulatory framework. How the products are categorised will simply be a matter of how the products are marketed and sold. Furthermore, in order to be provided with a medicinal product licence exemption certificate for all NCP-Rs, most electronic cigarette manufacturers, suppliers, and vendors (within, or supplying the UK), that chose to take this route would willingly be subject to an annual (or biannual) inspection by either the MHRA or Trading Standards in order to maintain their exemption status. Those companies that refuse to comply with these measures, or breach the exemption conditions proposed in this document, could then be easily dealt with appropriately by local enforcement agencies.

    Rationale for the proposal
    The following proposal is being put forward for consideration by the Department of Health and the MHRA; with a view to assisting in safeguarding their best interests and those of:
    • The Pharmaceutical companies selling products for the treatment of Nicotine Dependence Syndrome

    • Electronic cigarette manufacturers, suppliers, and vendors, who advertise their products for the sole purpose of them being used recreationally, as a direct-replacement alternative to cigarettes

    • And, most importantly, the general public and those that use nicotine recreationally but no longer wish to smoke conventional cigarettes

    Benefits of the Electronic Cigarette when compared with the Conventional (Combustible) Cigarette
    Whilst the concerns regarding electronic cigarettes for use as a medicinal NRT product have already been cited in MHRA Document MLX 364, the advantages of electronic cigarettes when compared directly with conventional (combustible) cigarettes are the following:
    • Electronic cigarettes do not produce by-products of combustion and they do not produce offensive acrid smells or second-hand smoke

    • Electronic cigarettes have been categorically proven by the Food and Drugs Administration to contain, in magnitudes of order, far fewer carcinogens and toxins (in both quantity and type) than conventional cigarettes (3)

    • Electronic cigarettes are not devices that require combustion in order to deliver nicotine, so these products can reduce some of the fire risks that have been attributed to / associated with the careless use of conventional cigarettes

    • Start-up costs of using electronic cigarettes are expensive, when compared with conventional cigarettes, and could potentially deter younger people from experimenting with them

    • Electronic Cigarettes are a positive step forward with regards to EC Directive EC/2001/37, Article 11
    The majority of Electronic Cigarette manufacturers and distributors in the UK are law-abiding businesses that have acted upon, without formal governmental assistance, on the measures available to them to safeguard both their customer’s and the general public’s health and safety. A few examples of the steps that have already been undertaken are as follows:
    1. Nicotine-containing electronic cigarette liquid is treated as “toxic” and the packing it is supplied in (by the majority of vendors) is compliant with the CHIP4 regulations and the emerging CLP regulations. In addition to childproof caps, CoSHH hazard warning signs are present on the labelling to alert individuals to the possible dangers present, and safety warning triangles are also affixed to alert the blind, and the partially-sighted, as to the inherent dangers of the contents of these bottles and cartridges

    2. Explicit warnings are advertised on the majority of legitimately run websites advising potential customers that electronic cigarettes are not smoking cessation devices, that they are not suitable for use by (or available to) anyone under the age of 18, those that are pregnant, or any individual predisposed to any problem associated with the use of nicotine

    IE the Current warning displayed on all Totally Wicked and TECC (The Electronic Cigarette Companies) Websites.

    WARNING: the electronic cigarette will not cure a smoker’s addiction to nicotine, the electronic cigarette serves the same purpose as a tobacco cigarette- it delivers its user nicotine. If you do suffer from the disease of 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.

    Please Note: We are not a pharmaceutical company and we do not produce medical products.

    3. The majority of vendors only permit transactions to be undertaken with a credit card or Paypal®, to ensure that the eligible customer is above the age of 18 before they can make a purchase

    4. In order to minimise product quality risks to consumers, a number of manufacturers in Europe now only use pharmaceutical-grade BP/USP/EP monographed raw materials in the manufacture of recreational nicotine-containing products

    Differentiating between Electronic Cigarettes for Therapeutic Use and Electronic Cigarettes for Recreational Use
    It is not disputed that manufacturers and distributors of electronic cigarettes who choose to make positive health or smoking cessation claims should not be subject to MHRA regulation and their products licensed. However, for those companies that wish to sell electronic cigarettes for recreational purposes only, the participants (representing the electronic cigarette industry) named in this document propose the following:
    1. Any customer making a first-time access to any website promoting these devices will be taken through a Nicotine Dependency Syndrome questionnaire devised by the Department of Health (Note 1). These series of questions will seek to ascertain if the intended customer is seeking treatment for Nicotine Dependency Syndrome, or if they intend to use the advertised products as an aid to stop smoking permanently.

    2. Using a “weighting system”, agreed by both the Department of Health and all participating electronic cigarette manufacturers and/or suppliers, if an individual is considered to be seeking help for the aforementioned condition the following steps will be taken:
    a. The customer will be refused sales service and will then be automatically directed to either the NHS Quit-Line, and / or, any other government approved smoking cessation initiative.
    b. The customer will be advised of the alternatives that can be used to stop smoking and be directed to the websites that sell MHRA-licensed smoking cessation products, such as J&J’s Inhalator, etc.
    Manufacturers, suppliers, and vendors, will agree to an annual (or biannual inspection) that grants them a product licence exemption certificate once they have satisfied the regulators (or Trading Standards) that:
    1. Procedures are in place to direct customer traffic to the appropriate help-lines and licensed medicinal products if they are seeking treatment for Nicotine Dependence Syndrome

    2. The electronic cigarette products being advertised are not making any positive health claims, either blatantly or covertly, that could in any way mislead, entice, or suggest, to the potential customer that these devices will assist them to stop smoking

    3. Procedures are in place to prevent access to such devices and products by anyone under the age of 18, and that the websites (and/or any advertising) is not targeted toward minors or those that do not already routinely use cigarettes
    Note 1. If a customer contacts a sales office by telephone for the first time, the exact same procedure (to determine if the sale is for the treatment of Nicotine Dependency Syndrome, or not) will apply.

    Benefits of the Alternative Proposal
    Implementation of such an option, as outlined in this document, will assist in providing the following benefits:
    1. For those individuals seeking treatment for Nicotine Dependence Syndrome, they will be directed to the appropriate healthcare channels to be dealt with by those qualified to do so in such matters. Furthermore, these individuals can then be advised of the therapeutic products available which will best suit their needs, were they not already aware. This form of “free advertising” will also assist in the unbiased promotion of all medicinally licensed products and help prevent electronic cigarettes diverting sales away from legitimate smoking cessation aids; thus ensuring that the pharmaceutical companies maintain control of their stake in NRT products

    2. The illusion that electronic cigarettes are a Nicotine Replacement Therapy, or a legitimate aid to prevent, treat, or cure, nicotine addiction, will be removed unless it has a product licence for such treatment

    3. The electronic cigarette industry will become legitimised by a regulatory framework, which is at present non-existent, and this can then be managed through a series of requirements that are punishable by confiscations, fines, or imprisonment, for any breaches

    4. In order to be provided with a product licence exemption certificate, electronic cigarette suppliers, vendors and manufacturers will have to comply with routine announced (or unannounced, where it is deemed necessary) inspections by either the MHRA or Trading Standards, in order to maintain their product licence exemption certification.

    Conclusion
    The following proposal is a fair and balanced alternative to an outright ban, or restrictive product licence requirement, where the current MLX 364 document does not take into account those individuals who simply do not wish to be treated for Nicotine Dependence Syndrome but do, however, want an alternative to conventional cigarettes; whether this choice is due to simple user-preference, or for personal hygiene reasons.
    An outright ban (or the insistence on a time-constrained product licence submission) at this juncture is only likely to drive the market underground (as did prohibition of alcohol in the United States during the 1930s) and encourage the purchase of these products from countries where the MHRA has no jurisdiction or control. Another factor to be taken into consideration will be the difficulties that are likely to be encountered in enforcing and policing a ban. Considering the number of people now using these products, it is highly unlikely that Revenue and Customs will be able to seize all shipments of electronic cigarettes and nicotine containing liquid imported into the UK should an “effective” ban be put in place. Furthermore, with regard to product safety, whilst participants in the European markets are taking pro-active positive steps to improve product quality standards by employing the use of pharmaceutical grade raw materials in their products, these expectations cannot be guaranteed by the markets outside of Europe.
    By creating two distinct categories of electronic cigarettes, those that wish to make health claims will have to go through the appropriate MHRA channels; and those that wish to sell them as a recreational product will have to satisfy the regulators or trading standards that they are exempt and be issued with a fee-payable product license exemption certificate. By employing a two-tier approach, both routes can be subject to a degree of regulation and appropriately controlled without destroying the electronic cigarette business entirely within the UK.




    Jason Cropper
    Managing Director

    Totally Wicked E-Liquid
    Electronic Cigarette e-liquid / Totally Wicked e-Liquid / electronic cigarette eliquid nicotine fluid products
    Electronic Cigarettes and eLiquid / Totally Wicked eLiquid / electronic cigarette eliquid nicotine fluid products

    The Electronic Cigarette Company
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  8. #28
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    Chrissie, please do not mistake a lack of posting for a lack of interest. Of course UK vapers care, it's just many, like me, find the political world hard enough to understand, let alone comment upon.

    But that doesnt mean, we have done nothing.

    When 30 or so Vapers met in York, we did discuss the threat over our head, and what further actions we may have to take, and prior to that, a lot of us did contact our MP's etc., and continue to keep them informed, and several of us, tried hard, to get UK members of ECF to participate, sadly with little effect.

    We also tried to form a Guild or Association amongst Suppliers, who of course want to do all they can to keep their businesses running, but it's not a straight forward thing to do, as it really needs one of them to run things.

    I have to agree 100% with hifistud, this is a political battle.

    As for awareness amongst vapers, I think most are aware, however, as the greater percentage never go near a forum, its not easy to get the word out. Newspapers are not interested, as to them vapers are a very small minority, its the same with local radio stations, they all want to appeal to the masses.

    However, having said that, we did get a small piece put into the local newspaper when we held our Minifest in York, so, maybe the formation of local vaping groups, would help, and then do as Rusy is doing, go around the pubs and breweries.

    Everything I have written here is why many dont post a response to this post. We were not at the meeting, and although Rolygate has done a superb job in relaying all that happened, we dont know what to do to help, except to come up with ideas on a level where we can help, just as I have done above.

    My point is, tell me what you want done..
    Tell me why it would help
    Tell me what the outcome may be
    Show me all are in agreement
    And then I will do it...


  9. #29
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    Petbe, as a first port of call I would suggest going to see your MP at his/her constituency surgery and taking along:

    • Your e-cigarette(s)
    • Some documentation explaining what the e-cigarette is, what it isn't, what the issues are regarding proposed legislation and why they are misplaced.
    • Your personal story


    As Rolygate said above, e-cigarettes are completely unheard of by the majority of people. Many of those who have heard of them think they are a gimmick, or dangerous, or both.

    The further issue is that most people believe (erroniously) that nicotine itself is the harmful constituent of cigarettes. I've found people are incredulous when it is explained that nicotine itself is relatively harmless, and that it's the products of combustion that cause the damage to health.

    When the facts are explained, almost everyone I've spoken to has expressed surprise, but accepts the logic. I believe that public education on this matter is essential. Whether it's possible to get the message out to enough people to make a difference is another question, but ensuring that all MPs are educated is, to my mind, the number 1 priority.

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    Jason, it seems you posted at the same time as me, so I didnt get a chance to read your post prior to posting my own.

    I agree with you, I choose to use an electronic cigarette, not to give up smoking, that was never my aim.

    All arguments I have read are based on one thing, giving up smoking. But what about the many who vape and smoke? What about those who simply use it as an alternative form of smoking?

    Im one of those people who are doomed to failure, why? because I'm always saying the magic words, Diet, Giving Up...

    When those words are changed, to Healthy Eating, Substituting, miracles do and can occur, so I never ever said, I'm going to buy an electronic cigarette and GIVE UP...

    I choose it because I DO enjoy using it,
    I enjoy the variety of tastes it allows me.
    I enjoy the fact that I dont stink of smoke,
    I enjoy the fact that my home remains cleaner.

    And, I enjoy being in control of all these things, and I am sure all vapers would agree, it's a choice, and one I want to retain.

    I have NOT used it to give up smoking, if I want a cigarette, I will have one, its my choice.


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