FDA Spokesperson Rita Chappelle Shoots Down Both the Device and The Nicotine For a Ban

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Legato525

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Mar 14, 2009
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Completely right about njoy. Though the fear in the BAN is valid, due to the fact that if njoy can afford testing and approval and become FDA approved, that does not mean the ban won't effect the products we want to buy. I can tell you right now, I hate njoy and if the ban were to go into effect and NJOY was the only game in town, I would go back to analogs. NJOY is too expensive and as much as I love my PV's, I cannot warrant spending that kind of money. The suppliers can follow NJOY's steps but that is not the cure all to our woes.
 

RjG

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Wow - as Lithium pointed out - "Miri Pharma, Inc. division of Canderm Pharma, Inc." owning a big chunk of Njoy now really puts a spin on things.

Lobbiests have a lot of power for big pharma industry. Enough to make idiot senators write letters... Now they are getting their hooks in to the e-cig market - ya, I can see why FDA gets involved all of a sudden. All about the $$$
Does Big Pharm Have Links to an Anti E-Cigarette Campaign? - Associated Content


Sick
 
Wow - as Lithium pointed out - "Miri Pharma, Inc. division of Canderm Pharma, Inc." owning a big chunk of Njoy now really puts a spin on things.

Lobbiests have a lot of power for big pharma industry. Enough to make idiot senators write letters... Now they are getting their hooks in to the e-cig market - ya, I can see why FDA gets involved all of a sudden. All about the $$$
Does Big Pharm Have Links to an Anti E-Cigarette Campaign? - Associated Content


Sick

Now THAT'S interesting - big pharm has a big chunk of NJoy?
Hmmmmm.
They've been testing the market.
PV's take off, time to kill off the competition, eh?


Now I REALLY dislike my NCig!
 

DisMan

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Sep 2, 2008
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How many times do we go through this in a day? It feels like this same discussion goes over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over....

Can't we just look at some nude chicks or something?
 

Letzin Hale

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Sorry, can't let this go:



Because that is not their job! They do not have authority over either tobacco or alcohol. They have authoritiy -- carefully spelled out in detailed law -- over food and drugs. E-smoking relies on a drug. That drug has never been approved as formulated.

It's NOT nicotine. Nicotine is usually 3% or less of the mix we vaporize and inhale. It's a drug mixture. And manufacturers didn't do their job, meet their responsibility, to get it approved before marketing it. We bought it. We became addicted to it (duh). We like it. It's not our fault we might lose it. Just don't think the FDA is doing something it doesn't have authority to do, or is overstepping its bounds, or isn't following prescribed procedure. It is doing exactly what it should be doing -- preparing to rule on a new drug.

It's a shame you have to keep repeating it for people to understand when, as you state, it's quite simple. One more good reason for the FDA's action is to avoid having the ... sued off them in future for failing to act if someone gets gallopingpoxflyswampfever from vaping some 'unclean' juice (have you seen where it is produced and in what conditions?!).
They might well be .... bureaucrats but they are doing a necessary job which should benefit us in the long run with more control over quality and cleanliness. The carts you put in your mouth, are they sterile?
Alan.
 

Lithium1330

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ECF Veteran
Nov 22, 2008
439
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See? keep digging and you will find A LOT of interesting info regarding how NJOY is doing bussines...

http://www.e-cigarette-forum.com/forum/e-cigarette-news/8264-fda-crackdown-looms-30.html#post129211

http://www.e-cigarette-forum.com/forum/e-cigarette-news/8264-fda-crackdown-looms-30.html#post129296

The key on this mess is just to go by the right ways and methods to keep the bussines going, EVERYTHING IS IN THE WORDING probably an "e-cigarette" is not allowed but a "nicotine inhaler" IS, probably "e-juice", "e-liquid" is not allowed but "diluted tobacco liquid" IS at least with customs.

The same aplies to the commercialization of the products, EVERYTHING IS IN THE WORDING the FDA takes into account the labels, indications and CLAIMS of the product to consider it a new drug or anything else, they don't base their desicion just in the technical aspect of the formulation.
 

Lithium1330

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ECF Veteran
Nov 22, 2008
439
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Mexico
Sorry for the double post, but this one is very interesting:

N045927
December 18, 2008
CLA-2-85:OT:RR:NC:N1:112
CATEGORY: Classification
TARIFF NO.: 8543.70.9650
Mr. Greg Pan, President Beijing Greenworld Technologies, Ltd.

54 Shunren Road, 2nd Building, 3rd Floor Shunyi District, Beijing 10130 China
RE: The tariff classification of various electronic cigarettes, pipes and cigars from China
Dear Mr. Pan:

In your letter received by this office on December 2, 2008, you requested a tariff classification ruling. The items subject to this ruling are various electronic cigarette, pipe and cigar products. The sample which you submitted is being retained by this office.

Each of the items concerned are electronic smoking devices in the shape of cigarettes, pipes and cigars. Each item is comprised of two primary components, a battery tube and an atomizer. The atomizer, which forms the mouth piece, is a device that contains an electronic triggering system that vaporizes nicotine-diluted or zero-nicotine liquids, which are safely sealed within the atomizer. The battery tube, which forms the body of the product, contains a microelectronic device with an integrated circuit, lithium battery, and a sensor, that collectively control the entire operating process. The first item subject to this ruling is the Senior Pack Starter Kit (Model # GT-G500-PP01). The kit contains a wooden sculptured electronic pipe bowl, 2 atomizers and a battery charger. The wooden sculpture pipe bowl incorporates the battery and electronic components. The atomizer forms the mouth piece. The combination of the electronic pipe bowl and the atomizer form the complete inhaler.
The second item subject to this ruling is the Nobel Pack Starter Kit (Model # GT-G300-IN01). The kit contains a cigarette holder, 2 cigarette battery tubes, 4 atomizers and 1 USB Cable. The cigarette battery tube forms the body of the electronic cigarette. The atomizer forms the mouth piece. The combination of the battery tube and the atomizer form the complete inhaler. The cigarette holder is also a battery charger.
The third item subject to this ruling is the Mini Pack Starter Kit (Model # GT-G300N-IN01). The kit contains 2 cigarette battery tubes, 4 atomizers and 1 charger. The cigarette battery tube forms the body of the electronic cigarette. The atomizer forms the mouth piece. The combination of the battery tube and the atomizer form the complete inhaler.
The fourth item subject to this ruling is the Standard Pack Starter Kit (Model # GT-G220-IN0-1). The kit includes two cigarette battery tubes, 4 atomizers, and one battery charger. The cigarette battery tube forms the body of the electronic cigarette. The atomizer forms the mouth piece. The combination of the battery tube and the atomizer form the complete inhaler.
The fifth item subject to this ruling is the Power Pack Starter Kit (Model # GT-G120-IN01). This kit contains one cigar shaped battery tube, 2 atomizers and 1 charger. The cigar shaped battery tube forms the body of the cigar. The atomizer forms the mouth piece. The combination of the battery tube and the atomizer form the complete inhaler.
In use, the act of inhaling initiates an atomization process which releases a simulated smoke. That smoke is actually a vapor mist which the user inhales. The remaining or secondary mist evaporates into the air within a few seconds without leaving harmful residuals. When the user inhales through the mouth piece, the electronic circuits start to work and the atomization process begins. When the user stops inhaling, the circuits stop working and the atomization process stops. The inhaler must be recharged when an indicator light on the inhaler does not turn red. The atomizers are available in 4 different nicotine levels, high, medium, low and zero.
The applicable subheading for each of the various electronic cigarettes, pipes and cigars (Senior Pack Starter Kit - Model # GT-G500-PPO-1, Nobel Pack Starter Kit - Model # GT-G300-IN01, Mini Pack Starter Kit - Model # GT-G300N-IN 01, Standard Pack Starter Kit Model # GT-G220-IN01 and Power Pack Starter Kit - Model #GT-G120-IN01) will be 8543.70.9650, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Electrical machines and apparatus…: Other machines and apparatus: Other: Other: Other: Other". The rate of duty will be 2.6%.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Steve Pollichino at (646) 733-3008.

Sincerely, Robert B. Swierupski Director National Commodity Specialist Division

Customs Rulings Online Search System (CROSS) Document Preview
 

Robb

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Mar 28, 2009
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Ya know, the Government in the USA makes a fortune from the taxing of cigarettes, alcohol, gasoline, etc., etc.

Part of the FDA's mission is safety........ but being able to regulate literally anything, amounts to Government dollars.

The Oil and Tobacco industry are well-known Huge lobbyists. So is the Pharmaceutical industry.

All provide massive dollars for the companys, and massive tax revenues for Government, from the Federal level all the way down to the City level.

Money's the main issue.

After all, Pharma still sells drugs that have been killing people taking them appropriately..... Cigarettes are a known killer....... Alternative fuels don't seem to be focusing as much on -not- using oil, just using more -USA- born oil instead of Middle Eastern oil.

Anyway, basically 'safety' is the so called "cover of the book" that is out there when you see the FDA. Once you open up the book, you see these: $$$$$$$$.

Dollars for all. It exists. With Pharma. With Tobacco. With Alcohol. With Oil. All those "safe" things. Yeah, ok.

Funny. Those dollars don't exist for e-cigs. And that's what's getting banned.

It's money. And there's nothing anyone can do about it.

So just wait. See what happens. And hope.
 

klum

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Mar 26, 2009
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You're right about the money aspect. Though, there is another angle on the tobacco vs. ecigs. The Government can never ban tobacco because the states are making huge cash from the tobacco firms. Not just in taxes but in settlements. Check out www .ag.ca.gov/tobacco/resources/msasumm.htm for a summary of the settlement that the states have with the tobacco companies. All told it will total over $200 Billion until 2025. Tobacco will never have the problems that e-cigs have because many of the states would go into finacial hardship without the settlement monies. I doubt any congressman or senator will take the ban tobacco stance too far without running in to this issue. Ecigs are an easier target, unfortunately for all of us.

kevin

Ya know, the Government in the USA makes a fortune from the taxing of cigarettes, alcohol, gasoline, etc., etc.

Part of the FDA's mission is safety........ but being able to regulate literally anything, amounts to Government dollars.

The Oil and Tobacco industry are well-known Huge lobbyists. So is the Pharmaceutical industry.

All provide massive dollars for the companys, and massive tax revenues for Government, from the Federal level all the way down to the City level.

Money's the main issue.

After all, Pharma still sells drugs that have been killing people taking them appropriately..... Cigarettes are a known killer....... Alternative fuels don't seem to be focusing as much on -not- using oil, just using more -USA- born oil instead of Middle Eastern oil.

Anyway, basically 'safety' is the so called "cover of the book" that is out there when you see the FDA. Once you open up the book, you see these: $$$$$$$$.

Dollars for all. It exists. With Pharma. With Tobacco. With Alcohol. With Oil. All those "safe" things. Yeah, ok.

Funny. Those dollars don't exist for e-cigs. And that's what's getting banned.

It's money. And there's nothing anyone can do about it.

So just wait. See what happens. And hope.
 

Robb

Full Member
Mar 28, 2009
9
0
Ohio
You're right about the money aspect. Though, there is another angle on the tobacco vs. ecigs. The Government can never ban tobacco because the states are making huge cash from the tobacco firms. Not just in taxes but in settlements.

kevin

Right. And states are.............. Government.

That's not another angle' though. Your post is saying it's money too, in a different way that it's "dispersed".

It's money. Money. $$$$$. Greenbacks. Whatever ya call it.

Simple as that. Tobacco produces massive amounts of money for all levels of Government, regardless of -how- it produces it. E-cigs don't.

Done.
 

jamie

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Jun 3, 2008
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Mr. Greg Pan, President Beijing Greenworld Technologies, Ltd.

54 Shunren Road, 2nd Building, 3rd Floor Shunyi District, Beijing 10130 China
RE: The tariff classification of various electronic cigarettes, pipes and cigars from China
In addition to this and the Njoy cartridge letter, there is a similar Njoy device letter... N027755

N027755

May 30, 2008

CLA-2-85:OT:RR:E:NC:N1:112
CATEGORY: Classification
TARIFF NO.: 8543.70.9650

Mark H. Weiss, Chairman
Sottera, Inc. DBA Njoy
4204 N. Brown Avenue
Scottsdale, Arizona 85251

RE: The tariff classification of Njoy Electronic Cigarette and Njoy Electronic Cigar from China

Dear Mr. Weiss:

In your letter dated May 6, 2008, you requested a tariff classification ruling.

The first item concerned is the Njoy Electronic Cigar. The electronic cigar is comprised of a metallic, tube shaped, housing. It incorporates a mouth piece on one end and an LED indicator light on the opposite end. The housing of the cigar is brown in color. Inside the housing is a replaceable ingredient/nicotine cartridge, rechargeable battery and a vaporization chamber. In use, the user would unscrew the indicator light at the end of the device and insert a rechargeable battery. At the opposite end of the device, the user would insert their choice of high, medium or low density nicotine cartridge. The electronic cigar operates using a 3.7 volt rechargeable lithium battery.

The second item concerned is the Njoy Electronic Cigarette. The electronic cigarette is comprised of a metallic, tube shaped, housing. It incorporates a mouth piece on one end and an LED indicator light on the opposite end. The cigarette is available in either a black or burgundy color. Inside the tube is a replaceable ingredient/nicotine cartridge, rechargeable battery and a vaporization chamber. In use, the user would unscrew the indicator light at the end of the device and insert a rechargeable battery. At the opposite end of the device, the user would insert their choice of high, medium or low density nicotine cartridge. The electronic cigarette operates using a 3.6 volt rechargeable lithium battery.

The purpose of the Njoy Electronic Cigar and Njoy Electronic Cigarette is to act as a nicotine inhaler. Both products heat and atomize the diluted tobacco liquid so that its flavor/vapor can be inhaled through the mouth piece.

You state that these two items will be marketed and packaged as follows:

1. The electronic cigar with two rechargeable 3.7 volt batteries and two refill cartridges.

2. The electronic cigarette with two rechargeable 3.6 volt batteries and a five pack of refill cartridges.

The applicable subheadings for the Njoy Electronic Cigarette and the Njoy Electronic Cigar will be 8543.70.9650, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Electrical…apparatus, having individual functions, not specified or included elsewhere…: Other…apparatus: Other: Other: Other: Other”. The rate of duty will be 2.6%.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Steve Pollichino at 646-733-3008.


Sincerely,

Robert B. Swierupski
Director,
National Commodity
Specialist Division
 

klum

Senior Member
ECF Veteran
Mar 26, 2009
112
0
Northern California
The other angle is it's not tax money, it's settlement money. Money that they get as long as Tobacco is around and is not dependent on how much tobacco is sold, it the same regardless of whether there's a billion packs sold or a thousand. Maybe not a wide angle but a different stream of money to the gov.

But yes, it's all still money.

kevin

Right. And states are.............. Government.

That's not another angle' though. Your post is saying it's money too, in a different way that it's "dispersed".

It's money. Money. $$$$$. Greenbacks. Whatever ya call it.

Simple as that. Tobacco produces massive amounts of money for all levels of Government, regardless of -how- it produces it. E-cigs don't.

Done.
 

redryder13

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Mar 29, 2009
0
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Florida
  • Deleted by Oliver

KDMickey

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ECF Veteran
Mar 10, 2009
112
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Denver, CO, USA
Ya know, the Government in the USA makes a fortune from the taxing of cigarettes, alcohol, gasoline, etc., etc.

Part of the FDA's mission is safety........ but being able to regulate literally anything, amounts to Government dollars.

The Oil and Tobacco industry are well-known Huge lobbyists. So is the Pharmaceutical industry.

All provide massive dollars for the companys, and massive tax revenues for Government, from the Federal level all the way down to the City level.

Money's the main issue.

After all, Pharma still sells drugs that have been killing people taking them appropriately..... Cigarettes are a known killer....... Alternative fuels don't seem to be focusing as much on -not- using oil, just using more -USA- born oil instead of Middle Eastern oil.

Anyway, basically 'safety' is the so called "cover of the book" that is out there when you see the FDA. Once you open up the book, you see these: $$$$$$$$.

Dollars for all. It exists. With Pharma. With Tobacco. With Alcohol. With Oil. All those "safe" things. Yeah, ok.

Funny. Those dollars don't exist for e-cigs. And that's what's getting banned.

It's money. And there's nothing anyone can do about it.

So just wait. See what happens. And hope.

Obviously, you're right. It always has been this way and always will be this way. Those who pay get their say.

BUT the only exceptions to this rule occur when people decide that there was something they could do about it. Only by dropping the "there's nothing anyone can do about it" attitude can we even hope to have our position heard.

Those of you that believe that nothing can be done by anyone, please go shove your heads in the sand. Those of us that believe things can be done, and that our efforts will matter, will continue to work, write, and advocate for our right to vape.

Cheers,
-Mickey
 

Taelon

Senior Member
ECF Veteran
Dec 20, 2008
212
1
DE-Germany
"Neither that device nor the vapor it produces has been approved by the Federal Drug Administration, Chappelle said.

The "e-cigarette" device (delivered without liquid) does not need FDA approval, it's simply a general purpose liquid vaporizer device which does not imply the use of nicotine/PG liquid or inhaling even if marketed so, so suppliers have Your lawyers ready and prepare to fight back, TropicalBob is not a lawyer.
 
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{snip} Only by dropping the "there's nothing anyone can do about it" attitude can we even hope to have our position heard.

Those of you that believe that nothing can be done by anyone, please go shove your heads in the sand. Those of us that believe things can be done, and that our efforts will matter, will continue to work, write, and advocate for our right to vape.

Cheers,
-Mickey

Work, write, advocate!!! Ostriches don't vape, so let's not be ostriches!

I can't stress this enough! Contact your representatives. Tell your personal story. Things like "I just noticed today that the crepey skin thing is gone!" - simply my personal revelation for the day....and after only 10 weeks of no tobacco!

Harm Reduction is key.

Also, contact your suppliers and get them involved if they aren't already.
 
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