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FDA approved ecig??? in Archive; Originally Posted by ramblingrose correspondence with ElectrikBlue: How do you justify your claims? All you have is FDA registration as ...
  1. #41
    TnA
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    Quote Originally Posted by ramblingrose View Post
    correspondence with ElectrikBlue:
    How do you justify your claims? All you have is FDA registration as an ENT inhaler, and its not legitimate as related to your claims. I'll be filing a complaint with the FDA. You're giving the industry a bad name at a time when it can do permanent damage.

    Elektric Blue reply: Hence why we say medical device and not the cartridge. We are just trying to sell a product to help people stop smoking. This product will be regulated in the near future at no fault to me or you, just like nicotine water, gum, patch, etc… If you feel you must try to harm one of us out there, then I guess do what you need to do. That really isn’t a positive or nice thing to do as I would never wish ill will on anyone. It isn’t our company that is giving the industry a bad name. It is Lobbyists from the Tobacco Industry. This will be a regulated industry because of the nicotine in the cartridges, as we do have an application in for the nicotine cartridge also and expect an approval in less than a year.

    My reply: It's one thing to sell a device that may help smokers quit, but another to make claims that haven't (at least not yet!) been proven. This is a very sensitive issue for legislators, lobbyists and the FDA. The sad truth is manufacturers and suppliers making these claims without controlled studies are feeding into the prevailing 'anti' attitude, which may make approvals more difficult to obtain. Use of these unproven claims is one of the FDA's complaints with the e-cig industry. We have enough to deal with in a society with strong anti-anything-that-resembles-a-cigarette sentiment, compounded by Big Tobacco and Big Pharmaceutical lobbyists. We shouldn't also have to contend with manufacturers and suppliers amplifying the problem.

    I don't wish you ill will, and hope you get your approval. But I believe that how you and others in the business handle yourselves at this point in time is critical to the industry's survival.
    Nice job ramblingrose. Well written/worded!

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    Don't get me wrong I am not defending this guy in anyway. But I read a post awhile ago that that somebody could not wait till the day they could go to the local corner store and pick up an atomizer some batteries and liquid. Would we not have to go through the process of having many vendors with different products then (anologs have different brands). I picked up a pack of anologs a week ago and made a comment to the clerk of how bad smoking is and her response was it can't be that bad everyone does it? Once again I am not defending him so please don't jump on me.

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    Got a responce similar to TnA got

    I would rather not get into a heated discussion with you as it is counter productive for both of us. We do not have false allegations on our website, as we have spoken to the FDA on numerous occasions. Hence why we say medical device and not the cartridge. We are just trying to sell a product to help people stop smoking. This product will be regulated in the near future at no fault to me, you, smoking everywhere - just like nicotine water, gum, patch, etc… If you feel you must try to harm one of us out there, then I guess do what you need to do. That really isn’t a positive or nice thing to do as I would never wish ill will on anyone. It isn’t our company that is giving the industry a bad name. It is Lobbyists from the Tobacco Industry. This will be a regulated industry because of the nicotine in the cartridges, as we do have an application in for the nicotine cartridge also and expect an approval in less than a year. And Trust me we are not a fly by night company. This is only one division of my companies investment firm. We are here to stay.
    I'll respond back later, but the blatent lie of being FDA approved will really come back and bite us in the butt eventually.

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    they are only FDA registered, which means nothing...

    Establishment Registration & Device Listing
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    Quote Originally Posted by LaceyUnderall View Post
    With more and more suppliers showing up, making claims that are obviously not on the up and up... my concern too grows for how this looks on the industry and what can be done regarding suppliers making such claims who are not ECA members.
    While I am very new to E-cigs and this forum it really isn't hard to see that this truly is a problem , not just for suppliers but for PV users in general.
    In my opinion the only thing that can really deal with companies that make such claims would be to play 'hard ball' with them.

    Notify them of what they are doing wrong, as I have seen done here already.
    Educate them on the requested course of action to rectify the issue. So far while I have seen several instances of people saying "You are not FDA approved, only registered." I have not seen a specific shot of, "Our only issue with your company is the statement you make on your page that you are FDA approved, if you remove (insert false information here) from your site, then you would be helping the cause." or whatever.
    If they continue to refuse, then start reporting them to any and every agency that is able to take direct action against them.
    Basically, do what you can to shut them down before they do more harm.

    Honestly, even though I am saying it, I do not like the last step of trying to have someones company or website shut down. However, being that the PV community is basically walking on eggshells (my interpretation) whatever we are capable of, and is necessary to ensure the survival of PVs should be done.

    This being said, I do have concerns about my own ideas. If we take these websites and/or companies and report them to the FDA I feel it can be taken/interpreted in two ways.
    The first (though not most likely IMHO) is the FDA will see we are actually TRYING to police our own community to ensure that no false claims are made that would be seen as violating FDA standards.
    The second, (IMHO most likely) option is the FDA will collect these reports of violating websites/companies and use them as ammunition to say, "Look at how many sellers are claiming this is a medical device to aid in the cessation of smoking! This MUST be stopped for the safety of our children!"

    Either way, I think the community as a whole, or majority should decide what we will do about such things. Maybe an issue to deal with when CASAA is up and running?

    Just my 20 cents, and my apologies if this is worded in a confusing manner.
    Last edited by Jodans; 10-22-2009 at 10:42 PM. Reason: Helping make extremely bad grammar into merely poor grammar.

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    Quote Originally Posted by LaceyUnderall View Post
    I just wanted to stop in and let everyone know that nycsublime girl has commented (not regarding the ECA's position, but Bloogs) and being on the board, she is aware, but I also have forwarded this thread onto the ECA for review.

    With more and more suppliers showing up, making claims that are obviously not on the up and up... my concern too grows for how this looks on the industry and what can be done regarding suppliers making such claims who are not ECA members.
    Lacey,

    I'd be very interested in hearing what Matt's take is on this and what ECA finds out. Maybe they will be more forthcoming with the ECA.
    Michal "Webby" Douglas - Proud User|Supplier|Advocate
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    Did anyone hear any more on this?

    Lu

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    Quote Originally Posted by Eric in AK View Post
    Look at this information on their "News" page:

    "Smoking has a wide variety of negative health effects and can affect nearly every organ in the body. But the organs that are most adversely influenced are your lungs. Of course, as everybody knows, your lungs help you breathe."

    I always wondered where the air went when I inhaled, and now I think I know.....the lungs....who would have guessed?

    See? Who needs TV or newspapers when you can get that kind of news on the internet?!?
    LMAO! Oh man what an idiot! Shut 'em down I say!!
    Until one has loved an animal, a part of one's soul remains unawakened.

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    Super Member ECF Veteran Snarkyone's Avatar
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    Like I said earlier we should all spam his phone number and let him know that claims like the ones he is making do more harm than good here in the US with the anti crowd, they will eat him alive if he tried those claims. It's what got us in the mess in the first place.

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