Fda approval!

[TropicalBob]

Yeh, well GreenCig let the world know it had been "certified" by the FDA. And they provided a link to the form to confirm it. Trouble is, certified isn't the right word.

I went from excitement to oh-no in about two hours. Sorry to cut short any whistled version of "Dixie".

[markab]

Hi TB,
Hehe, no problem. Thanks for the info. I live in Canada, but I'm sure that our government will be interested in what the FDA has to say regarding any e-smoke product.
For now I'll just keep my fingers crossed.

Regards,
Mark

Originally Posted by TropicalBob

Yeh, well GreenCig let the world know it had been "certified" by the FDA. And they provided a link to the form to confirm it. Trouble is, certified isn't the right word.

I went from excitement to oh-no in about two hours. Sorry to cut short any whistled version of "Dixie".

[Tee Cee Trade Nld]

yeah, greencig prices are still kinda high..... but the taste is not bad at all... wow, I really would be very happy when any company good be approved.. but not like a medicine right!

[Texas]

Interesting find...
fda.gov/bbs/topics/ANSWERS/2002/ANS01144.html

Also found this while doing searches... Seems like this company got disapproved because the article appears to be a new drug without an approved new drug application. (so is there something else in them?)

fda.gov/ora/oasis/11/ora_oasis_i_66.html
Manufacturer FEI: 3006805905
Manufacturer Name: Cixi Ecig Technology
Manufacturer address line 1: No 145 Danshan
Manufacturer address line 2:
Manufacturer's City: Zhejiang
Manufacturer Province/state:
Manufacturer Country: China
Product code: 66BAY44
Importers product description: E-CIGAR, E-CIGARILLO, E-CIGARETTE, E-PIPE, E-MINICIG, E-PACK
Refusal date: 21-NOV-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: FS2-1085481-6/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
NOT LISTED


Manufacturer FEI: 3006805905
Manufacturer Name: Cixi Ecig Technology
Manufacturer address line 1: No 145 Danshan
Manufacturer address line 2:
Manufacturer's City: Zhejiang
Manufacturer Province/state:
Manufacturer Country: China
Product code: 66BAL44
Importers product description: E-CARTRIDGE, E-LIQUID
Refusal date: 21-NOV-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: FS2-1085481-6/3/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
NOT LISTED

[TropicalBob]

Excellent find. I personally haven't been keeping up with the FDA. The reason for "unapproved" is ominous:

Reason: UNAPPROVED
Section: 505(a), 801(a)(3); UNAPPROVED NEW DRUG
Charge: The article appears to be a new drug without an
approved new drug application.

These are E-Cig applications, BTW.

And this is a very recent rejection!

[GabbyD]

What exactly is the nicotine we're using in e-liquid? I've seen some here say it's synthetic. Does anyone know for sure? Does it have a name? I've been poking around on the FDA site and see them banning things because they use a form of nicotine already FDA approved as a drug, therefore the product is a drug being compounded and distributed in an illegal way. The flip side is a different form of nicotine that has not been approved for use as a drug, and in that case it would be banned for being a "new drug" that hasn't been FDA approved. Screwed either way, as far as I can tell.

[TropicalBob]

Gabby ... interesting that you ask. In earlier threads (many months ago), we all tried to find out the TYPE of nicotine in e-liquids. No manufacturer or supplier tells us. Yet the FDA has said only one specific type will be allowed for consumption -- the kind used by Big Pharma for all NRT products.

It was the TYPE that initially killed the nicotine water and lip balm applications. Without any other consideration, the FDA said the type was illegal.

P.S. You are correct with your final conclusion.

[Myk]

The way I read it the FDA says only one kind is allowed for consumption in an NRT device.
Not that only one kind is allowed for consumption.

Only one kind allowed for any consumption would allow them to get into regulating herbals which they haven't been able to manage although they've tried.
The closest they've came is because of meth labs.

[TropicalBob]

This has all been rehashed (pun intended) in the past on this forum. Read the FDA papers on Nicowater. One kind is allowed. Gabby is correct in her summation.

[nqhqhz]

Originally Posted by Myk

The way I read it the FDA says only one kind is allowed for consumption in an NRT device.
Not that only one kind is allowed for consumption.

Only one kind allowed for any consumption would allow them to get into regulating herbals which they haven't been able to manage although they've tried.
The closest they've came is because of meth labs.

You're quite right, in the vast majority of western countries the laws prohibiting molecules generally don't apply to the plants containing them unless they are prepared for consumption or extracted.

As tobacco is one of the few narcotic plants to be tolerated, it is noteworthy that the same thing applies the other way round, thus:

Tobacco is legal regulated and exempt, however, its active constituent, nicotine, is not. It is considered a poison, which must be considered distinct from controlled drugs and medicines. (though some can be considered both of the latter, for instance, Marinol)

Nicotine sulphate, on the other hand, is a medicine used in NRT. In my opinion, the fact that it is a different salt probably makes little difference. It was pointed out that the lollipops were not nicotine sulfate (it was as likely to be the same kind of nicotine we are using) but even if they were, they need to go through various trials to prove that it's of medical use. Even if e-cigarettes were using nicotine sulphate, it wouldn't be much help, someone would need to run clinical trials to see if they were useful as NRT.

The only body I can think of that deals with legal recreational drugs, which is what this is to us surely, is ATF in the US (and this product is neither alcohol nor tobacco in the US). This is because of the policy of prohibition.

Interestingly, in Irish law, a tobacco product is defined thus:

For the purposes of this Directive, the following definitions shall apply:


(a) ‘tobacco products’ means all products intended to be smoked, sniffed, sucked or chewed inasmuch as they are made, even partly, of tobacco;

I wonder is an e-cigarette included in that definition, since it is partly made of tobacco (tobacco nicotine, tobacco flavouring oils, propylene glycol are all in cigarettes) and it is sucked, but not perhaps sucked in the manner proscribed by the law?

Worth considering... especially since tobacco products are taxed by weight, and 20ml of e-liquid weighs about two cigarettes...