Fda approval!

[Mr.Darcy]

Originally Posted by 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...

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]

Originally Posted by 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.

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]

Originally Posted by TropicalBob

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 f'n 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

Originally Posted by 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.