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Fda approval!
It appears that GreenCig has become the first electronic cigarette to obtain certification from the U.S. Food & Drug Administration.
Its cigarette is officially a "nasal inhaler" by FDA definitions. To be one, the device must deliver a drug through nose, mouth or throat. Certainly an e-cigarette takes that route to deliver its nicotine.
GreenCig makes disposable and non-disposable cigarettes and is readying a disposable cigar for sale in the U.S. The company, GreenWorld, is American invested but manufactures in China.
This certification is astounding news and means that, unless the e-cigarette is challenged by a Congressman, it likely will be legal to sell these devices in this country without hearings, demands for clinical trials and proof of efficacy.
You can read the brief certification statement and follow links to definitions at FDA > CDRH > Registration & Listing Database Search
Its cigarette is officially a "nasal inhaler" by FDA definitions. To be one, the device must deliver a drug through nose, mouth or throat. Certainly an e-cigarette takes that route to deliver its nicotine.
GreenCig makes disposable and non-disposable cigarettes and is readying a disposable cigar for sale in the U.S. The company, GreenWorld, is American invested but manufactures in China.
This certification is astounding news and means that, unless the e-cigarette is challenged by a Congressman, it likely will be legal to sell these devices in this country without hearings, demands for clinical trials and proof of efficacy.
You can read the brief certification statement and follow links to definitions at FDA > CDRH > Registration & Listing Database Search
via: E-Cigarette Forum
Tags: The Law Discussion
5 comments for “Fda approval!”
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I hate to break it to you but GreenCig does not have FDA approval but not for an e-cigarette device. If you take a look at this post on the e-cigarette forum you will see what Im talking about.
http://www.e-cigarette-forum.com/forum/law-e-cigarette/1652-regulating-tobacco.html
It looks like they are trying to pull the wool over everyones eyes… I was suckered in by the same claims and was discussing doing business with these guys but after a bit more investigation I have decided that I dont want to do business with someone who makes claims of this nature that are not true. I even went so far as to defend them at one point. I have learned my lesson.
Phil
http://www.e-smokeytreats.com
Damn it!
I got all excited when I read the “fda approval” headline. Something like this would be a huge step forward for the E Cigarette industry but as it stands I’m beginning to think E Cigs will never live up to their early promise. We really need some sort of official approval if the E Cigarette is to gain the general public’s acceptance.
I would like to know how to buy an e cigarette.
Gloria, if you would like to buy an eCig, you can start here:
http://esmokersmag.com/topic/buy-ecigarettes/
Make sure to do your research, a good starting point for that would be here:
http://esmokersmag.com/electronic-cigarette-buyers-guide/
The bill specifically states that the F.D.A.’s new powers would stop short of the ability to order the elimination of nicotine from tobacco products or place an outright ban on all tobacco products.
But the agency could reduce nicotine to non addictive levels if it determined that doing so would benefit public health. The F.D.A. could also require changes in tobacco products, like the reduction or elimination of other harmful ingredients.
I agree that it looks like the E. Cigs are not FDA approved. Getting the FDA approval for the E. Cig as an inhaler medical device; is an interesting angle. When it comes to delivering various strengths of nicotine; this is where the problem is for approval. This said, the E. Cig is not a tobacco product. If you read the quote above; where would products like the nicotine patch or nicotine gum fall with this law?