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

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. 8-o (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 .... 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]

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 .... 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...

 

[Myk]

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.

This is not water. Water is a food, nicotine is not a food additive and they were marketing the nicotine water as NRT, and they were using a drug form of nicotine. That clearly puts it in the jurisdiction of the FDA.
As long as the nicotine in e-liquid is not a drug form and qualified for NRT (which is why it was turned down as NRT) it is not a drug. They would have to do like AU did and reclassify which would extend to other forms of nicotine like cigarettes.
The FDA has tried to get their hands on tobacco as a drug and they lost.
Nicotine water has been reformulated and is now marketed as a tobacco product.

I don't care if it's been rehashed a million times if those million times were wrong.

I know what went on with ephedra. I know what went on with the FDA and tobacco. I know what went on with the FDA and nicotine water. I know what the most recent refusal by the FDA over e-liquid was about.

 

[Rockbassray]

Ok here is a thought... has ANYONE ever really tested that there juice or cartridge has nicotine in it? where is the proof that nicotine is in our juice? just cause you say you feel it doesnt mean it is in there.. could be a placebo effect.

 

[TropicalBob]

Did you read the rejection of E-Cig's petition to the FDA? It's a "new drug", the FDA said in rejecting it. If it's a new drug, it will be rejected. If it's an existing drug, it will be medicinal and both liquids and delivery devices will be subject to regulation as medicines are. That's what Gabby was concluding.

And she's right. It's lose-lose.

 

[nqhqhz]

A correction to my post above; that is EU law, not Irish law. The Irish law is exactly the same, however.

Ok here is a thought... has ANYONE ever really tested that there juice or cartridge has nicotine in it? where is the proof that nicotine is in our juice? just cause you say you feel it doesnt mean it is in there.. could be a placebo effect.

Nicotine has been shown to have a demonstrable effect compared to placebo. the Ruyan paper from Health New Zealand also shows that there is nicotine in the cartridges, as has the assay of Totally Wicked E-Juice.

They would have to do like AU did and reclassify which would extend to other forms of nicotine like cigarettes.

I'm interested to know what you mean by this. Do you mean that if legislation regulated nicotine, such a regulation would have to extend to tobacco?

 

[Myk]

Did you read the rejection of E-Cig's petition to the FDA? It's a "new drug", the FDA said in rejecting it. If it's a new drug, it will be rejected. If it's an existing drug, it will be medicinal and both liquids and delivery devices will be subject to regulation as medicines are. That's what Gabby was concluding.

And she's right. It's lose-lose.

Geez, it's a new drug because it was put to them as NRT but doesn't contain old drugs approved as NRT.
If it's not put to them as NRT they have no real jurisdiction, although I'm sure they will try.
If it's kept as a tobacco product and a smoking alternative they have no jurisdiction other than to try and claim it's not a tobacco product in order to get jurisdiction.
The easy answer is for everyone in this country to stop claiming it's NRT and simply say it's a safer way to use tobacco.

Maybe you'll find this FDA link educational,

On March 21, 2000, the U.S. Supreme Court ruled that the U.S. Food and Drug Administration lacks the authority to regulate tobacco. Therefore, FDA no longer maintains its Children and Tobacco Website.

Tobacco Redirect Information

 

[Myk]

I'm interested to know what you mean by this. Do you mean that if legislation regulated nicotine, such a regulation would have to extend to tobacco?

As far as I can tell the nicotine in e-liquid is taken from plants, there are other "essences" from tobacco.
That is not drug form nicotine, it is a form of tobacco. The FDA cannot regulate tobacco without getting the law changed.

China's problem is they claim it is NRT in their country and ship that around with their product. They also tried to get it approved here as NRT.
I imagine that claim will have to stop.

 

[Kate]

How about this, Johnson Creek have FDA approval - nicotine liquid is ok -

Kate - update: I just received confirmation from the President of JC that the FDA approval is for both the facility and the product.

http://www.e-cigarette-forum.com/forum/general-discussion/5064-our-numbers-growing-3.html#post81426

True or false ... would Johnson Creek lie?

 

[GabbyD]

Registered is not the same as having approval. I've seen it discussed here but I'll be damned if I can locate it in quick time. I'm betting TB knows.

 

[TropicalBob]

Here's some more bad news: Congress this term will vote on legislation to give the FDA specific authority it now lacks over tobacco. The bills are virtually assured of passage, with overwhelming support.

Read;

Congress should end this special protection for Big Tobacco by passing legislation to give the FDA authority to regulate tobacco products. The public health community strongly supports bipartisan bills that have been introduced in Congress:

S. 625 sponsored by Senators Edward Kennedy (D-MA) and John Cornyn (R-TX).

H.R. 1108 sponsored by Representatives Henry Waxman (D-CA) and Tom Davis (R-VA).

This legislation would:

Crack down on tobacco marketing and sales to kids.

Require larger, more effective health warnings on tobacco products.

Require tobacco companies to disclose the contents of tobacco products, changes to their products and research about the health effects of the products.

Grant the FDA authority to require changes in tobacco products, such as the removal or reduction of harmful ingredients.

Ban candy-flavored cigarettes.

Prohibit terms such as "light", "mild" and "low-tar" that mislead consumers into believing that certain cigarettes are safer.

Prohibit health claims about so-called “reduced risk” products that are not scientifically proven or that would discourage current tobacco users from quitting or encourage new users to start.

This legislation has been co-sponsored by a majority of both the House and the Senate. It has been endorsed by more than 680 public health, faith and other organizations across the country. And it is supported by 70 percent of American voters.

The big deal is not just FDA taking jurisdiction from the old ATF agency, but the fact that the FDA is likely to impose heavy restriction on how much "addictive" nicotine will be allowed per cigarette. Makers would be required to market only non-addictive smokes. Lotta pleasure there, eh?

I suppose the real horror here is the number supporting this transfer of power. The efforts to pass this began after a court said the FDA did not have authority over tobacco.

It soon will!

 

[Myk]

Here's some more bad news: Congress this term will vote on legislation to give the FDA specific authority it now lacks over tobacco. The bills are virtually assured of passage, with overwhelming support.

Read;



The big deal is not just FDA taking jurisdiction from the old ATF agency, but the fact that the FDA is likely to impose heavy restriction on how much "addictive" nicotine will be allowed per cigarette. Makers would be required to market only non-addictive smokes. Lotta pleasure there, eh?

I suppose the real horror here is the number supporting this transfer of power. The efforts to pass this began after a court said the FDA did not have authority over tobacco.

It soon will!

That could be a problem. It was a Republican Congress who told the FDA no before the Supreme Court decision and now we're back to Democrats.

I assume the SCOTUS decision was about internal laws and not Constitutional since there is no FDA, BATFE or tobacco in the Constitution.

But that was a previous session. It was rushed through the House and seems to have died in the Senate.
No more actions taken after August, they probably were trying to keep their jobs and taking away people's addictions close to an election is not a good way to do that.
So they act like they are for something to get the anti's on their side and then don't follow through to keep the pro's with them.