Fda approval!

[TropicalBob]

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

See further thoughts on this on page two of this thread. GreenCig has registered, not been given any kind of FDA approval. Go deep into that FDA date listing and you'll see that no approvals have been given and GreenCig claims exemption from approvals. We shall see.

 

[karenwest1961]

Good job, Bob!

 

[Mr.Darcy]

wow!THAT came out of the blue...well done greencig,and well done Bob!

 

[Evil Santa]

Party! Time!

 

[CaSHMeRe]

TIME TO PAAARRRTTAAAAYYY !!!! Thanks for posting TB, this is great news!

 

[dc2k08]

and still not one review of their products. they appear to be building a solid base before launching.

 

[CaSHMeRe]

and still not one review of their products. they appear to be building a solid base before launching.

They can't ship as they are based in Beijing. Both their manufacturing plant and distribution centers are and any large quantity based order with batteries/liquid will get stopped immediately until after the olympics. Smaller/Personal orders get shipped fine, Distributor orders, not so much!

 

[dnakr]

I may be the only skeptic here - but I don't think it is going to be that easy. Lets hope I am wrong...

 

[dc2k08]

They can't ship as they are based in Beijing. Both their manufacturing plant and distribution centers are and any large quantity based order with batteries/liquid will get stopped immediately until after the olympics. Smaller/Personal orders get shipped fine, Distributor orders, not so much!

hmm..so do you think that the orders smokster, pillbox and meltrex make are small enough to ship, cause they seem to be ordering their stuff out of china just fine at the moment or am i wrong? also green-cig could ship their small orders from china if they wanted..no?

 

[ned Zeppelin]

Today people have seemed to be quite unsure regarding green cig and who they are but I can reassure people that they are all kosher and legit.
As I have personally been having business telephone conversations with them in the last few days.
Their aim is to try and bring green cig into the UK but mainly in the mainstream of things rather than Internet but there will be a Internet site.
It will be aimed more at the retail market. Shops/ stores/ businesses etc.
More like as you would see the top brands websites where you only see janty. N joy. Sedansa etc only for sale on their own sites not mixed up with suppliers selling all sorts . Whether that will change I don't know. As I think they want to have a more prestige look.
They are a US invested company with a manufacturing plant in China.


So this is all good for us as for spreading the word into the mainstream. I feel this must go this way as it is at present to Internet-based which that is all right but it needs to get out there for people to accept and get used to because at the moment it's only people like ourselves that showing a man on the street what we have.

 

[Mr.Darcy]

I may be the only skeptic here - but I don't think it is going to be that easy. Lets hope I am wrong...

well at least its a positive start Rachel...we have so few positives and so many negatives to cope with...so no harm in a little moment of optimism...

 

[dnakr]

its not a matter of shipping it from China, its a matter of shipping it out of Beijing itself. most chinese manufacturers don't ship from Beijing, they ship from different parts of China, or so my sources tell me

 

[ned Zeppelin]

Why are people rattling about getting it in and out of Beijing for.
When for all they know stock might be already in Europe
When a company does a company launch normally they will have sufficient amount of stocks ready to go.

 

[dc2k08]

i'll be keen to see their disposable model. these cigs are very much priced in the upper tier though. i hope they can go better than loongs batteries prices.

 

[CaSHMeRe]

Why are people rattling about getting it in and out of Beijing for.
When for all they know stock might be already in Europe
When a company does a company launch normally they will have sufficient amount of stocks ready to go.

Trust me for what this is worth. GreenCig has the stock, they just can't move it Speaking of Beijing China Distribution ofcourse. Not sure whats going on in Europe.

 

[TropicalBob]

Rachel is right to be cautious. The closer you read the "fine print" the more you realize that this is a registration. In no way is it "certification" (what GreenCig calls it) or "approval." All companies selling stuff like this are required to register with the FDA, in case a bad item needs to be tracked back to the manufacturer. That's what GreenCig has done. It registered.

Surely we have an e-cig smoking lawyer in our ranks! I'm blurry-eyed from reading legal crap on the FDA site. The bottom line seems to be that the FDA has given nothing to GreenCig -- no green light, no certification, no approval. The FDA could turn around tomorrow and decide to hold full hearings on these devices.

It is, after all, GreenCig that registered this as a nasal inhaler exempt from further FDA requirements. The FDA didn't select that category for an electronic cigarette. Remember that Nicowater was being sold in American airports six years ago as a "dietary supplement." It was registered and the company was advertising. Then the FDA decided that wasn't the reality. The product was banned after a hearing.

Initial enthusiasm thus dampened, I'm stuffing my fireworks back in the boxes.

 

[karenwest1961]

Initial enthusiasm thus dampened, I'm stuffing my fireworks back in the boxes.

Aww damn Rach! Now look whatcha did. He picked up his toys and went home.

All kidding aside, in order not to misrepresent (thus ... with the federal government), will GreenCig be required to name it and market it as an inhaler?

Proprietary Name: GreenWorld Inhaler; Xintian Inhaler
Classification Name: INHALER, NASAL

I mean, the name GreenCig will NOT cut the mustard with Uncle Sam with "cig" in the name. That'll send a red flag up right away.

 

[dnakr]

After re-reading all the material that drew my attention to this "not flying" decision - I see that this device will have to go through PMA (Premarket Approval) therefore, the red flags will waive and it will not pass.

GreenCig registered this under a generic category. The guidelines clearly state "Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when...

FDA > CDRH > CFR Title 21 Database Search

This will then be re-classified and held until approved through the proper channels.

 

[CaSHMeRe]

nice research Rach! thanks for clearing this up

 

[markab]

Gee TB, First you've got me whistling dixie.... Now I'm on my fanny!
Well, none the less, It will be interesting to see how things unfold.

Mark

Rachel is right to be cautious. The closer you read the "fine print" the more you realize that this is a registration. In no way is it "certification" (what GreenCig calls it) or "approval." All companies selling stuff like this are required to register with the FDA, in case a bad item needs to be tracked back to the manufacturer. That's what GreenCig has done. It registered.

Surely we have an e-cig smoking lawyer in our ranks! I'm blurry-eyed from reading legal crap on the FDA site. The bottom line seems to be that the FDA has given nothing to GreenCig -- no green light, no certification, no approval. The FDA could turn around tomorrow and decide to hold full hearings on these devices.

It is, after all, GreenCig that registered this as a nasal inhaler exempt from further FDA requirements. The FDA didn't select that category for an electronic cigarette. Remember that Nicowater was being sold in American airports six years ago as a "dietary supplement." It was registered and the company was advertising. Then the FDA decided that wasn't the reality. The product was banned after a hearing.

Initial enthusiasm thus dampened, I'm stuffing my fireworks back in the boxes.