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Our Member, Frubbish to give ABC TV News Interview on E-Cigs Tomorrow - Let’s Wish Frubbish Luck!!

Discussion in 'Media and General News' started by Sun Vaporer, Mar 19, 2009.

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  1. RjG

    RjG Super Member Verified Member ECF Veteran

    Oct 16, 2008
    Edmonton AB Canada
    Well, here's your FDA laws, for your evening reading...

    Section 510
    and SEC. 513. [21 USC 360c ] Classification of devices intended for human use.
    FD&C Act Chapter V, Sections 513-523
    are good reading, if you intend on keeping the "e-cigarette" as a nicotine delivery device, or as a NRT device

    new drugs is here: FDA > CDRH > CFR Title 21 Database Search

    All of this stuff is 100% dependent on the device being used for nicotine, because nicotine IS a drug.

    like a broken record - market our P.V.'s as a "herb vaporizer" device with a herb and water cart in the box, and none of the above applies.


    And yes Kate, as long as it is marketed as an e-cigarette, then it is still is a nicotine drug delivery device whether the cart has nicotine in it or not.
     
  2. bizzyb0t

    bizzyb0t Super Member ECF Veteran

    Mar 13, 2009
    Denver CO, USA
    Exactly... but good luck getting the Chinese and the distributors to change their marketing, wording on the site, and literature. Some sites will have to abandon their domain name entirely...
     
  3. Kate

    Kate Moved On

    Jun 26, 2008
    UK
    So the only way for traders to sell devices legally is to not sell them as cigarettes or with nicotine.

    Eliquid presumably is illegal to sell at all. I wonder where that stands for personal possession and use.
     
  4. RjG

    RjG Super Member Verified Member ECF Veteran

    Oct 16, 2008
    Edmonton AB Canada

    Well this makes sense, in a twisted way.... I've read the form letter before, but didn't quite get why a device was being labelled "new drug", that's odd.

    BUT - if you read this part of that section:
    FDA > CDRH > CFR Title 21 Database Search

    you will see it is referencing NRT's as a device containing nicotine, under "new drug". So now the quote makes sense. The above quote from the FDA specifically targets the manufacturers throwing around the "quit smoking" phrase. ( Which was stupid to begin with, we can all agree.)

    none of which changes - label/promote/document it differently, same device, no legal issues.
     
  5. Kate

    Kate Moved On

    Jun 26, 2008
    UK
    What do you think is the status of eliquid RjG, have you found much about how that will be regulated or enforced?
     
  6. RjG

    RjG Super Member Verified Member ECF Veteran

    Oct 16, 2008
    Edmonton AB Canada

    I would have thought illegal on all counts, it is a drug AND an extremely potent poison after all.... but our law is based on the Queen's, and you lucky U.K. folk appear to have gotten away with adding warning labels, and childproof containers :) So I am hopeful Canada wil follow that...
     
  7. Kate

    Kate Moved On

    Jun 26, 2008
    UK
    We've been lucky in the UK. Eliquid slipped through the requirements for poisons law and is being ignored by medical/health product regulators. All they've said is to take down the NRT and health claims.

    Fingers crossed for Canada.
     
  8. DisMan

    DisMan Super Member ECF Veteran

    Sep 2, 2008
    Jesus Christ people....we have TB coming in with "the FDA says it's illegal so it's illegal", then the news report says "Because they contain nicotine, the FDA says they are illegal". So we have all this confusion...WHY ARE THEY ILLEGAL? In the end, the FDA is calling it a new drug...if nicotine is why these are illegal, where the "new" part of "new drug" coming into play?

    The FDA then quotes a section of law in official statements. Let's look at that section of the law, shall we?

    (p) The term ``new drug'' means--
    (1) Any drug (except a new animal drug or an animal feed bearing
    or containing a new animal drug) the composition of which is such
    that such drug is not generally recognized, among experts qualified
    by scientific training and experience to evaluate the safety and
    effectiveness of drugs
    , as safe and effective for use under the
    conditions prescribed, recommended, or suggested in the labeling
    thereof, except that such a drug not so recognized shall not be
    deemed to be a ``new drug'' if at any time prior to June 25, 1938,
    it was subject to the Food and Drugs Act of June 30, 1906, as
    amended, and if at such time its labeling contained the same
    representations concerning the conditions of its use; or
    (2) Any drug (except a new animal drug or an animal feed bearing
    or containing a new animal drug) the composition of which is such
    that such drug, as a result of investigations to determine its
    safety and effectiveness for use under such conditions
    , has become
    so recognized, but which has not, otherwise than in such
    investigations, been used to a material extent or for a material
    time under such conditions.

    So, my argument is simple...where is the statement and investigations required to call these items "new drugs"? I haven't seen them yet. Anybody else seen them? Who are the experts? Where is their report? If the FDA is making such a statement, then I (as a citizen of the USA) would like to see the published findings.

    Until then, I don't see where the FDA has any jurisdiction at this time.
     
  9. Nuck

    Nuck Ultra Member ECF Veteran

    Feb 14, 2009
    Ontario, Canada
    That report was excellent. The net result will be a lot of new smokers wanting to get their hands on an ecig. Good job guys.
     
  10. RjG

    RjG Super Member Verified Member ECF Veteran

    Oct 16, 2008
    Edmonton AB Canada
    Disman - go read the relevant sections, I posted them just a few posts back.

    FDA is attempting to call an E-CIG an NRT device, classified as a "drug-device combination". And under that premise, everything posted there applies, since the e-cig is part of the whole NRT.

    remove the nicotine part, and the literature and markings related to nicotine, and that whole premise is toast. OK??
     
  11. DisMan

    DisMan Super Member ECF Veteran

    Sep 2, 2008
    No sh*t. That's what I was saying. It's only a new drug because it contains nicotine. That's the bottom line. So, sell zero nicotine cartridges with the device and the problem is solved.
     
  12. fjames

    fjames Senior Member ECF Veteran

    Mar 3, 2009
    Bluegrass USA
    I've just been poking around the FDA site, mostly to find out info on Rita, who so seems to scare everyone here. Couldn't find anything, so I'm going with my instinct and saying she's just another PR person, which whether corporate of government, means basically nothing. She's a mouthpiece with no authority and people should stop quoting her IMNSHO.

    What I did find was a listing of stopped e-cig shipments. Commonalties of all were they seemed to be labeled as e-cigs or e-cig parts, and the shipper in all cases was either UPS or Fed-Ex. On the same list were deodorant, skin cream and other apparently irrelevant stuff.

    The US government is process oriented, not performance oriented. It's all about filling out the right forms in the right way. This leads to massive corruption (our Medicare system is forever being ripped off by doctors in poor areas with phony patients because they've figured out all they have to do is fill out some forms to get a bunch of gov. money,) huge expenditures that achieve nothing, or even worse have a negative impact (pollution laws that don't define the levels of allowable pollution but instead simply define a "process" for the company to follow and assume all is well as long as, wait for it ... the forms are properly done) and all sorts of modern evils of our industrialized world.

    It's just the US gov. doing its thing, while we and our suppliers do ours. May the best dog win.
     
  13. taukimada

    taukimada Ultra Member ECF Veteran

    Jan 23, 2009
    Tullahoma, Tn
    just as a note... i have no intention of doing more research on this.. i'm quite sure you know how to google and can conclude on your own :)

    i really don't care what the FDA says unless they ACT on it... personally i think they are doing alot of foot stomping but something/someone is tying their hands... but this little ditty may explain the foot stomping in the first place...

    source is Court and Congress to Press FDA to Regulate Nicotine,

     
  14. TropicalBob

    TropicalBob Vaping Master ECF Veteran

    Jan 13, 2008
    Port Charlotte, FL USA
    I think this issue was resolved by the Supreme Court, which said the FDA could not regulate tobacco products without a new law from Congress. That new law is in the works, but not completed. Note the 1995 date on your ASH comments. Lord help us if ASH ever gets it way on anything!
     
  15. LaceyUnderall

    LaceyUnderall Ultra Member ECF Veteran

    Dec 4, 2008
    USA and Canada
    As always, I thank everyone for their efforts for more links to help me prepare a pretty strong argument for the electronic cigarette, a style of personal vaporizer.

    For those who agree with my stance, you confirm that I am not reading something that is not there and for those in my opposition, you help me see what lies ahead before I actually hit that bump, helping me prepare an even stronger argument for all of us.

    Either way, back on topic of this thread... this was a fairly done report, our boys did well... and we can only hope for more reports that are fair and objective. These reports will create more users and more voices and in the end, that's what we really need - happy and satisfied users who are willing to stand up for their alternative smoking devices.
     
  16. taukimada

    taukimada Ultra Member ECF Veteran

    Jan 23, 2009
    Tullahoma, Tn

    sadly ASH did get it's way on that item... which is why we don't have nicotine lollipops and lip balm.. when i found that link i also spotted the more recent nicotine water but chose that one because it was a legal mandate given to the FDA to DO something about a nicotine product instead of SAY.. the point basically being.. they had been legally mandated to take action.. and had chosen to not act.. thus the courts were decided they were in violation.. ie see previous "foot stamping" statement
     
  17. ruggz

    ruggz Senior Member ECF Veteran

    Feb 26, 2009
    saint paul, MN
    I was just watching the news and they are advertising a story on e-cigs for monday night @ 10pm channel 5 kstp.
     
  18. taukimada

    taukimada Ultra Member ECF Veteran

    Jan 23, 2009
    Tullahoma, Tn
    i just reminded myself of something...

    i honestly have no clue of people's opinions of my statements... and in a way.. i don't care.. with one small exception.. i dont want anybody getting the idea that i THINK im overly knowledgable about ANY of these issues...

    i really am just another idiot american consumer hoping for the best and realizing that my hopes are most likely to be dashed upon the rocks of bureaucracy yet again...

    i do my research sporadically.. but i don't STUDY anything.. if i happen to see something i'm curious about i tend to run a google and browse points... so feel free to correct me if you see an actual mistake... as long as you point it out simply i have no problem verifying one way or the other.. or choosing to be lazy and not..

    thank you for your time... and yet again... good job Frub and Bizz
     
  19. TheEmperorOfIceCream

    TheEmperorOfIceCream Ultra Member ECF Veteran

    Jun 1, 2008
    London, UK
    Great job guys, I think you came over very well. And I don't think we've seen as balanced a piece of reporting as this before now (certainly not a video piece). Props all round, to our guys and the reporters.

    Emp
     
  20. NicoNut

    NicoNut Senior Member ECF Veteran

    Jan 5, 2009
    Atlanta, Georgia USA
    Frubbish and Bizzy...thanks so much for stepping up for us all, you both did a stand up job! :thumb: I thought the clip was fair, one of the best ones I've seen so far, and a good advertisement for e-cigs.

    :confused: Still confused as to why anyone was jumping on the reporter or Kate? Hopefully everyone calmed down after the actual clip came out...hey, we're all on the same side!:cool:
     
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