UK MLX 364 Proposal

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Vocalek

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Here is the link to the MHRA documents.
MLXs: Medicines consultation letters : MHRA

Download the first PDF document listed.

If you don't want to do that, at least write and tell them how using e-cigarettes has affected your tobacco smoking and your health.

You can email your comments to
Amanda.bryan@mhra.gsi.gov.uk

Use this as the Subject line: CONSULTATION LETTER MLX 364
 

Territoo

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  • Jul 17, 2009
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    Just wondering why the UK proposal of MLX 364 is not being discussed here or even mentioned on the CASAA website?

    I thought CASSA was meant to be a global organisation?

    Poor show guys

    I'm gonna borrow Kristin's soapbox for a moment and remind all that every member of CASAA is CASAA and there is no need to wait for the Board to act. If you feel an issue needs to be discussed, then by all means, start a discussion. Don't wait for someone else to do something.

    Here's your soapbox back, Kristin. BTW, check out some of Vocalek's posts on the main thread pertaining to this subject, then say that CASAA isn't doing anything.
     

    womblebat

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    Vocalek

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    Sorry, just now saw your response, so my last one above was not intended to be a response to yours (#3). I just wanted to save folks some time from popping all over to gather up the required information to take action.

    In response to #3, right now, the CASAA web site doesn't have a designated spot for information such as this. One of the features that we plan to add to the CASAA site is a "Call to Action" that stays visible on all pages -- probably another Tab where the News and Events are located. This will take time to implement, as it requires a programmer. We're doing the best we can with an all-volunteer organization.

    As far as discussions go, why rely on the Board of Directors to begin discussions? All members of ECF are free to post in this sub-forum, and anyone can join the CASAA forum boards and post there. Welcome to CASAA - Consumer Advocates for Smoke-Free Alternatives Association

    This is your organization too.
    ---
    Ooops, looks like Terri and I were on the same wavelength.
     

    womblebat

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    I'm gonna borrow Kristin's soapbox for a moment and remind all that every member of CASAA is CASAA and there is no need to wait for the Board to act. If you feel an issue needs to be discussed, then by all means, start a discussion. Don't wait for someone else to do something.

    Here's your soapbox back, Kristin. BTW, check out some of Vocalek's posts on the main thread pertaining to this subject, then say that CASAA isn't doing anything.

    You have completely missed the point Territoo, CASAA is the place people come for information on legalities and new proposals, be it here or their website, that's the whole reason for them being here, the fact that members are chipping in on scattered threads is all well and good but it should have been announced on their subforum and website.

    Learn how to use a soapbox before you step on it ;)
     

    Webby

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    I have to agree with Womble. People in the UK already have this information, what we would like is a response from CASAA, Kate has asked this many times. This would be a good time to proove to us that CASAA is a global community and not just one dealing with American issues.

    It was brought up early on whether or not CASAA would be a US or “truly international” organization.

    International laws differ widely from country to country, and before we try eating that global elephant in one bite (and subsequently shooting ourselves and any established credibility down the drain) we opted to fight the issue of Judge Leon’s pending decision and the FDA embargo, first.


    Lest our friends (and members) across the pond feel CASAA has left them out, I offer you this:

    Understand that CASAA is a group made up of primarily U.S. members. I personally, have no reason NOT to send clear disapproval message but without some semblance of representation (official or otherwise) we are clearly at a disadvantage on several fronts. If a thread needs to be started here (and I agree it does) I do feel it needs to be started by someone in the UK (oh hey – look you did!)AND I would expect the burden of educating CASAA’s members to be that of those of you who can enlighten the rest of us as to where we can help.

    If CASAA is truly to be a representative of our membership (global or otherwise) it is the responsibility of everyone in the vaping community to share in the communication. Our phone and email lines are steadily contacted by curious new members wanting answers and anti-smoking groups looking to find a ..... in the armor to discredit us. I’ve been amazed by the frankness of several of our contemporaries on the other side of the fence who were surprised to find we DO NOT hide behind pseudonyms and proxy servers. If you want to talk to me or any of CASAA’s Board, we are easy to find.

    What we’d like to hear from are people like you. Personally, the only times in my life I’ve ever gotten in real trouble is when I acted like I knew something I didn’t. CASAA proves daily that we aren’t afraid to speak up on local, municipal, state or federal levels in the U.S. Taking the fight to help our European allies isn’t something we’re afraid to do, but no one is about to go off half cocked or carry a knife to a gun fight.

    How would you recommend CASAA help our members in the UK. ?

    Trust me. We’re listening.
     

    kristin

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    Folks, please keep in mind that we are not omnipresent. There's just a few volunteer board members. We can't be heading off every situation on our own. We need our members to tell us what they need and we'll do what we can as soon as possible. Ask and ye shall receive!

    The only reason we seem to be more on top of U.S. stuff is because that is where the board is headquartered & what we are familiar with. But we are well aware that the status of vaping across the globe affects each and every vaper everywhere. We rely on our members in each country to let us know what, when and where they need support. So, if you don't see anything on your situation - just tell us and we'll do everything we can to gather CASAA member support!
     

    deewal

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    So, if you don't see anything on your situation - just tell us and we'll do everything we can to gather CASAA member support!

    Thanks kristin. We could really do with your writing talents on this one as this is an opportunity too good to miss. I've posted here.
    http://www.e-cigarette-forum.com/fo...arette-delay-costing-lives-2.html#post1016812

    Could you possibly give it a read. I think the title of the thread has been making people ignore it but you will see what i mean about opportunity.
    I'm not a Writer ( allthough i do write and have written songs in the 70's and even now that are Commercially Published and Recorded ) so we really need your help if possible.
    Thank you very much.
     

    womblebat

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    Thanks to Vocalek, Webby and Kristen, all i was after was acknowledgement on this issue as it has been going on for day's now with limited support, links and stickies are gratefully received.

    Just to mention that a lot of our American and European vaping friends have been signing the petition link below, check it out, it all helps :)

    UK regulation of electronic cigarettes Petition
     

    kristin

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    Thanks kristin. We could really do with your writing talents on this one as this is an opportunity too good to miss. I've posted here.
    http://www.e-cigarette-forum.com/fo...arette-delay-costing-lives-2.html#post1016812

    Could you possibly give it a read. I think the title of the thread has been making people ignore it but you will see what i mean about opportunity.
    I'm not a Writer ( allthough i do write and have written songs in the 70's and even now that are Commercially Published and Recorded ) so we really need your help if possible.
    Thank you very much.

    We are working on getting an official statement together to submit to the MHRA consultation. We are asking all CASAA members - especially those familiar with the situation - to participate HERE. After that, we can see about contacting Deborah Arnott, as the letter to MHRA may double as a letter to UK ASH.
     
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    westcoast2

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    . After that, we can see about contacting Deborah Arnott, as the letter to MHRA may double as a letter to UK ASH.
    D Arnott was part of the NICE citizens consultation and heavily promoted NRT. NICE are on the MHRA consultation cc list, ASH(UK) are not (odd?). The MHRA options need to be read together with the NICE citizens council report to get an all around view.

    As I said to Deewal on the other thread, ASH (UK) are likely to support option 1, which makes ejuice a medicine, as this supports their position and that of the RCP. This effectively also supports the FDA position in the US. (as does option 2). ASH (UK) support a 'harm reduction' strategy that involves medicinal nicotine, this is not where many want the e-cig positioned. For instance, if the US vaping community want e-cigs as a medicine why the concern in the FDA case, where the FDA want just that?

    From the comments around, it seems a number of people may have been mislead on the consequnces of option 1 and 2 in the MHRA consultation. They think this is simple regulation. It is not. Medicinal regulation is complex and the end result to Vaping as we know it is very uncertain.

    Part of the problem is the misleading wording of MHRA option 3. MHRA option 3 suggests that e-cigs (juice) are unregulated. This is not true. There are a number of regulations in place for ensuring the quality and safety of e-cig products.

    If anything other than option 3 is supported then e-cig (juice) will become a medicne with all that that entails.
    ----
     

    deewal

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    D Arnott was part of the NICE citizens consultation and heavily promoted NRT. NICE are on the MHRA consultation cc list, ASH(UK) are not (odd?). The MHRA options need to be read together with the NICE citizens council report to get an all around view.

    As I said to Deewal on the other thread, ASH (UK) are likely to support option 1, which makes ejuice a medicine, as this supports their position and that of the RCP. This effectively also supports the FDA position in the US. (as does option 2). ASH (UK) support a 'harm reduction' strategy that involves medicinal nicotine, this is not where many want the e-cig positioned.
    ----
    With all due respect westcoast2, Deborah Arnott was backing Fire-Safe Cigarettes and was quoted by the BBC thus
    "Deborah Arnott, of anti-smoking group Ash, said the cigarettes would mean a "significant decline" in fire deaths."
    More than 100 people die in the UK every year from fires caused by cigarettes which are dropped or discarded without being extinguished.


    I was not/am not aware that Fire- Safe Cigarettes are sold as or Marketed as a "Medicinal Nicotine" but as a "Harm Reduction Strategy" which is quite different. ASH UK have already stated in Document ASH_715.pdf available on their website.......
    ASH’s position on e-cigarettes​
    ASH supports a harm reduction approach to tobacco, that is, we recognise that whilst
    efforts to help people stop smoking should remain a priority, many people either do not wish
    to stop smoking or​
    fi nd it very hard to do so. For this group, we believe that products should
    be made available that deliver nicotine in a safe way, without the harmful components found
    in tobacco. Most of the diseases associated with smoking are caused by inhaling smoke
    which contains thousands of toxic chemicals. By contrast, nicotine is relatively safe.
    Therefore, e-cigarettes, which deliver nicotine without the harmful toxins found in tobacco
    smoke, are likely to be a safer alternative to smoking. In addition, e-cigarettes reduce secondhand
    smoke exposure since they do not produce smoke.
    There are, however, a number of problems with e-cigarettes.
    1. Most deliver a low dose of nicotine which may not give a typical smoker a suf
    fi cient
    ‘hit’ to satisfy cravings, discouraging smokers from continuing to use them.
    2. Because the products are unregulated there are some concerns about their safety
    since few manufacturers disclose the ingredients of their products.
    3. So far, there have been no clinical trials to prove that they can help people to stop
    smoking. In the absence of such evidence, ASH therefore recommends that people who
    want to quit smoking should use nicotine replacement therapy or other proven
    pharmacological aids such as Champix (varenicline) or Zyban (bupropion).

    Regulation​
    The UK’s Medicines and Healthcare Regulatory Authority (MHRA) has ruled that certain
    brands of e-cigarettes cannot be classi
    fi ed as medicinal products and therefore do not fall
    under the remit of the MHRA. Although rulings are made on a case by case basis, it is likely
    that the same ruling would apply to similar products. Currently, e-cigarettes are subject to
    general consumer protection Iaws and it is the responsibility of trading standards of
    fi cers to

    rule on their safety.

    Now the MHRA have changed their stance but as far as i am aware ASH UK has not Published an Addendum or Update to this Document.

    By now we all know that Johnson and Johnson who are owned by GlaxoSmithKline who produce Nicorette have applied for a Licence for their "New Improved etc, etc" and had it granted by the MHRA who now wish to crush the opposition. ASH UK must be aware of this and are keeping their heads down as GlaxoSmithKline also just happen to own a large stake of The Phillip Morris Company who manufacture the Product which ASH was formed to fight against.
     
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    Vocalek

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    From the comments around, it seems a number of people may have been mislead on the consequnces of option 1 and 2 in the MHRA consultation. They think this is simple regulation. It is not. Medicinal regulation is complex and the end result to Vaping as we know it is very uncertain.

    Part of the problem is the misleading wording of MHRA option 3. MHRA option 3 suggests that e-cigs (juice) are unregulated. This is not true. There are a number of regulations in place for ensuring the quality and safety of e-cig products.

    If anything other than option 3 is supported then e-cig (juice) will become a medicne with all that that entails.
    ----

    Would you elaborate a little on the regulations that are already in place for quality / safety of e-cig products, please?
     
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