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Thread: The FDA in the US has started cracking down on vendors

  1. #1
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    The FDA in the US has started cracking down on vendors

    There might not be any official and direct regulation in place for vaping in the states yet, but there are some current laws and regulations that have apparently allowed this to occur.

    Johnson Creek Enterprises, LLC 9/8/10
    This is a warning letter to Johnson's Creek.

    Both the "drug" and "device" definitions in sections 201(g) and 201(h) of the Act (21 U.S.C. 321(g) and (h)) encompass products intended either to affect the structure or function of the body or to cure, mitigate, treat, or prevent disease. Based on our review of the Johnson Creek Smoke Juice products and their associated labeling and promotional materials, these products are drug-device combination products, with a drug primary mode of action. Statements in labeling and promotional materials, including your Internet website at Johnson Creek Smoke Juice - We Make Premium Smoke Juice for all electronic smoking devices! Johnson Creek Smoke Juice. that reflect these intended uses for the products you market include, but are not limited to, the following: (it then goes into comments lifted off the damned website left by customers)
    I dug this up on reddit, and had to swing by to see if people had seen it yet.

    Comment from a reddit user:

    This regulation has been around for a while, and applies to other things other than eCigs. It allows the FDA to ensure that companies are not making falsehood representation of a product without proper FDA approved studies behind it.
    Although we all know damn well that most people who switch from Analogs to eCigs we basically quit cigarettes, but the label "smoking deterrents" on a product has to be granted from the FDA themselves.
    The letter (I read most of it, before I started to fall asleep) quotes this from the Johnson Creek Enterprise website:
    Why E-Smoke? . .. Most people who smoke, do so because they enjoy the tactile, emotional and physical sensations. E-smoking provides pleasures similar to those commonly associated with traditional smoking ...
    The issue the FDA is clearly listed on the bottom:
    As described in 21 C.F.R. 310.544, any product that bears labeling claims that it "helps stop or reduce the cigarette urge," "helps stop or reduce smoking," or similar claims is a smoking deterrent drug product.7
    Which then in the next paragraph goes into this:
    The Johnson Creek Smoke Juice products marketed by your firm are also misbranded under section 502 of the Act (21 U.S.C. 352) because they are intended for use as smoking deterrents under 21 C.F.R. 310.544 but are not covered by an approved new drug application
    To be classified as a "smoking deterrent" device you have to be classified as a new drug, which has been tested for that application. As stupid as that sounds, that is technically the "law" by the FDA. The one thing that does really piss me off is that in the middle of the letter to Johnson Creek you see them quoting customer reviews. pineapplepineapplepineapplepineapple off FDA, seriously? Unless there is concrete proof that this is a fake review, then you should not be able to sensor your citizens in that fashion.
    There were a few more of these I have seen before (dating back to 2009/2010), but I cannot find them. If someone can find it that would be awesome.
    This is not a good thing to hear. I guess people are going to have to start being extra vigilant when talking about vaping. Remember: It's an alternative to smoking. Not a smoking cessation device.

    I have to get back to work now, but yeah... this kind of makes me grumpy JC is one of the more "powerful" companies in terms of who they are partnered with. It's worrying.
    Fatman, spud and avtek like this.
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  2. #2
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    rynxa that is huge! there is no way that johnston creek can comply with all their demands within 15 days - to do so they would have to have a whole department set up just for this

    full on! i think we are going to see a lot of juice manufacturers have closing down sales - interestingly i have seen nothing of this on other news feeds

    also using their definitions in the fda letter that u linked - hardware could also be hit as well
    Last edited by avtek; 09-11-13 at 07:30 PM.

  3. #3
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    That was three years ago.
    FDA didnt do shit.
    ckane, Fatman, Rynxa and 1 others like this.

  4. #4
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    oops didnt look at the date arth i thought it was like yesterday

  5. #5
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    Huh At the time JC (or more correctly their fans) were making a few smoking cessation claims etc and they got pulled up on it .. sorted and business as usual
    Rynxa and spud like this.
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  6. #6
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    Retarded me did not check the date. I even found a related post in my "vape pol/sci" bookmarks folder from yonks ago. Please squish this thread FM. It's old and kind of irrelevant. I should stick to work when I am working and ignore the internet, I don't fact check super hard when I am busy with other things
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  7. #7
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    Thread closed to preserve Rynxies 100% grade point average
    EPM V2-18490 (X2 ),GP Spheroid V2.5 and GP Piccolo V2.5 ,BBCB, Provari mini's, REO mini V2.1, 18490 REO , Jazz Carto Pipes ( fitted with GA tank and churchwarden stem Totally Evil!!! ), Meerschaum pipe ,e-holly35W,Phideas, AIOS,Taifun atties, PC Pipe mods.PC Squonker, Svapiamo squonker, GP Paps Heron combo.

    Vaping since 2007 totally smoke free since 2011


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