Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

Status
Not open for further replies.

Sun Vaporer

Moved On
ECF Veteran
Jan 2, 2009
10,146
27
Florida
If so, this means that the ECA is pursuing the "we are in the tobacco category" line as opposed to going after controlled drug approval? njoy drew a line in the sand (which I can understand as they did it in April), but that may not be in the best interest of the other suppliers. On the other hand, one could argue that as goes njoy goes the industry.

I just wish they would have taken a different approach from the get go (when they started manufacturing, not when they filed the suit).


Duckies--that is thinking and to tell you the truth, I am not sure NJOY or SE is or should be the "industry standard" by any means.

NJOY did indeed draw a line in the sand and the interests of many other suppiers are not being represented.

Sun
 

LoneRanger

Senior Member
ECF Veteran
Jul 18, 2009
227
0
Florida
I really do not know what you are referring to Lone--the case? The case could not resolve itself weeks ago as there is another hearing to be had. Judge Leon will not rule until after this hearing as there are two statutory schemes he has in which he could rule under.

Sun
And what would be that? no disprect intended.
 

Duckies

Super Member
ECF Veteran
Mar 20, 2009
565
7
Philly
Duckies--that is thinking and to tell you the truth, I am not sure NJOY or SE is or should be the "industry standard" by any means.

NJOY did indeed draw a line in the sand and the interests of many other suppiers are not being represented.

Sun
Yes, that is very frightening. So many of our good suppliers got off on the right foot by marketing these responsibly and now may have to pay the price for SE's nonsense claims after they made a fortune hawking them. I can appreciate nJ's involvement on the ECA, but it sounds to me like there is nothing of benefit to the little guys who took a different approach.
 

ravengrim

Full Member
ECF Veteran
Jul 23, 2009
54
4
52
Florida
I assume that Njoy did what they did because of something I was reading earlier today.
If I am wrong then I'm sorry,I don't usually post anything in here becuase this is only for the daily update.
Lawmakers want tobacco put under FDA control - Los Angeles Times
This is an old story,but please tell me if I understand what I'm reading.
Does this story say that the bill didn't let the F.D.A. ban tobacco or nicotine ?
 
Last edited:

TheIllustratedMan

Super Member
ECF Veteran
Jun 12, 2009
442
12
Upstate, NY
If so, this means that the ECA is pursuing the "we are in the tobacco category" line as opposed to going after controlled drug approval? nJoy drew a line in the sand (which I can understand as they did it in April), but that may not be in the best interest of the other suppliers. On the other hand, one could argue that as goes nJoy goes the industry.

I just wish they would have taken a different approach from the get go (when they started manufacturing, not when they filed the suit).

Whoa, hold the phone...

E-ciggies help 45% smokers quit: News24: SciTech: News

According to Matt Salmon, president of the Electronic Cigarette Association (Eca) in the USA, available data indicates that electronic cigarettes reduce the risk of illness and death to under 1% of the risk posed by tobacco cigarettes "which are responsible for 400 000 deaths per year in the US - more than Aids, drugs, homicides, fires and auto accidents combined".

Apparently the ECA's position is that they prevent disease. That makes them a drug, and subject to FDA regulation.
 

Sun Vaporer

Moved On
ECF Veteran
Jan 2, 2009
10,146
27
Florida
And what would be that? no disprect intended.


Lone--Judge Leon can rule under the present statutory scheme or the new legislation recently passed should he find merit in doing so. That is why another hearing was requested by Judge Leon.

And yes--there are many Suppliers here that did everything right and have no representation in this case. These Suppilers are taking a beating, many of them losing their life savings. So it is not out of line by any means to call out the fact that they are not being represented independantly outside the sphere of NJOY and SE.

Neither of these entites even bothers to participate on this Forum or any other for that matter. Nor does either of these 2 companies offer e-liquid or the ability to buy atomizers. A warranty on an atomizer that you have to wait for in the mail or the mandate to purchase prefilled cartridges does not represent the e-cig industy as a whole

Sun
 

LoneRanger

Senior Member
ECF Veteran
Jul 18, 2009
227
0
Florida
Duckies--that is thinking and to tell you the truth, I am not sure NJOY or SE is or should be the "industry standard" by any means.

NJOY did indeed draw a line in the sand and the interests of many other suppiers are not being represented.

Sun
How can you say such against Njoy? they have been up front since the get go- in sales & marketing.
 

TheIllustratedMan

Super Member
ECF Veteran
Jun 12, 2009
442
12
Upstate, NY
TheIllustratedMan, That doesn't say anything about preventing -- it says "reduce risk". You can stay in the tobacco category with a "risk reduction" stance.

So at what point does "reduced risk" equal "disease prevention"? You're talking about a product that they swear up and down is only being marketed to long-term smokers. By claiming reduced harm, you are saying "If these people continue to smoke, there is a good chance that they will suffer from one or more smoking related diseases. By using the electronic cigarette instead, their chance of contracting one of those diseases is cut 100 times." That means that for 99 out of 100 people, you are preventing them from getting a disease they would have gotten had they continued their habit of smoking.
 

Sun Vaporer

Moved On
ECF Veteran
Jan 2, 2009
10,146
27
Florida
How can you say such against Njoy? they have been up front since the get go- in sales & marketing.

A cartridge is the equivelent of a pack of cigarettes? You are inhaling a water vapor?

I will repeat it here:

There are many Suppliers here that did everything right and have no representation in this case. These Suppilers are taking a beating, many of them losing their life savings. So it is not out of line by any means to call out the fact that they are not being represented independantly outside the sphere of NJOY and SE.

Neither of these entites even bothers to participate on this Forum or any other for that matter. Nor does either of these 2 companies offer e-liquid or the ability to buy atomizers. T. A warranty on an atomizer that you have to wait for in the mail or the mandate to purchase prefilled cartridges speaks volumes about these two companies. That is NJOY's and SE's right to do business. But other Suppliers employ different methods that may indeed be a more viable and accurate "representation" of the e-cig Suppilers.

Sun
 

Duckies

Super Member
ECF Veteran
Mar 20, 2009
565
7
Philly
So at what point does "reduced risk" equal "disease prevention"? You're talking about a product that they swear up and down is only being marketed to long-term smokers. By claiming reduced harm, you are saying "If these people continue to smoke, there is a good chance that they will suffer from one or more smoking related diseases. By using the electronic cigarette instead, their chance of contracting one of those diseases is cut 100 times." That means that for 99 out of 100 people, you are preventing them from getting a disease they would have gotten had they continued their habit of smoking.
I don't think anyone here has illusions about preventing diseases such as COPD or lung cancer by using PVs. The damage to long time smokers is already done.

Ever hear of the smokers paradox? That is the theory that posits ex-smokers are more likely to contract lung cancer within the first 5 years of quitting than at any other time. Two reasons given for this -- one is that the tar keeps the cancer from taking off and the other is that our lungs will eventually heal over time (I have heard 10 years to get to the state of a non-smoker's lungs).

If you smoke, you can't prevent these diseases. If you can't quit, a 'safer' alternative is an option, but that doesn't undo the damage.

If Sun is correct in his assumption that anything considered less risky is classified 'drug' as opposed to 'tobacco', then we have a mess because that is not what nJoy/SE and apparently the ECA are trying to make happen.
 

Sun Vaporer

Moved On
ECF Veteran
Jan 2, 2009
10,146
27
Florida
No! they do not claim they prevent disease. -Period-

Lone--they may not claim it, but that does not mean that this is not its "intended use" under the guise of the law. The "intended use" can and will be imputed by the Court if it is found that people use NJOY to quit smoking for a "healther" alternative.

One would be hard pressed to argue that that is not in fact what we all are doing.

Sun
 

TropicalBob

Vaping Master
ECF Veteran
Jan 13, 2008
5,623
65
Port Charlotte, FL USA
It absolutely is what we're doing. The FDA has written that the intended purpose of electronic cigarettes is to treat a medical condition called nicotine addiction. Not prevent. Not cure. Treat nicotine addiction by providing nicotine in a vaporized form.

That makes the liquid that creates the vapor a drug; that makes the e-cig a drug delivery device.

Stammer all you want but regulatory authorities will care only about a product's intended use, potential for misuse, side effects to users, and any threat to non-users (especially children) from any new drug product.
 

LoneRanger

Senior Member
ECF Veteran
Jul 18, 2009
227
0
Florida
Lone--Judge Leon can rule under the present statutory scheme or the new legislation recently passed should he find merit in doing so. That is why another hearing was requested by Judge Leon.

Sun
If other suppliers did not join in it's there fault. Why didn't they join in? As far as the mail
hand delivered?NEVER had a problem with fresh cartridges from Njoy. Why should they participate in forum? (maybe silence is golden?)

Lone
 

Sun Vaporer

Moved On
ECF Veteran
Jan 2, 2009
10,146
27
Florida
If other suppliers did not join in it's there fault. Why didn't they join in? As far as the mail
hand delivered?NEVER had a problem with fresh cartridges from Njoy. Why should they participate in forum? (maybe silence is golden?)

Lone


Lone--It is not what NJOY is doing, we all know that---rather it is what the ECA is NOT doing. The ECA is not representing the interests of vast majority of suppliers in any negotiations for a possible fast track regulatory scheme. If, in fact one is worked out, it will be on the terms and conditions that are advantaous to NJOY and SE---not all the other Suppliers.

What I am trying to say if that I find it suspect that the ECA did not implead themselfs into this case, if in fact they are representing the 'core values' of the industry. I do not think you will find to many people on this Fourm or anywhere for that matter that see NJOY and SE as a true representation of the e-cig industry. The voices of most Suppliers has been muted by this inaction of the ECA in my opinion.

There is a chance that the FDA would work with the industry on a fast track system for regulation that all concerned could live with--but that should not mean just NJOY and SE.

Sun
 

LaceyUnderall

Ultra Member
ECF Veteran
Dec 4, 2008
2,568
5
USA and Canada
TheIllustratedMan, That doesn't say anything about preventing -- it says "reduce risk". You can stay in the tobacco category with a "risk reduction" stance.

This is true. Look at all of the "reduce risk" products currently in the tobacco category, including a product that doesn't include tobacco at all: Tobacco Free Snuff I think it is. It contains absolutely no tobacco, no TSNA's and is a tobacco product. Now how is that? It is that way because a tobacco company put it onto the market.

The original quote from Matt was also based off of scientific data as presented by Dr. Nitzkin.

There appears to be some confusion in writing styles and quoting as the ECA's message is that the electronic cigarette is a Reduced Risk Product and should be warranted the same rights as the Reduced Risk Products put out by Big Tobacco. The issue here is that there are only two thought processes: Tobacco or Pharmaceutical and according to the ATF way back when, they did not want the risk reduced products UNLESS they are produced by Tobacco companies, of which manufacturers/suppliers of Ecigs are not.

In order to fall into the Pharmaceutical group, claims would have to be made in order to fall into FDA jurisdiction. The FDA is arguing (rightfully so) that the electronic cigarette sold by Smoking Everywhere is in fact under their jurisdiction due to the marketing claims. nJoy is arguing that electronic cigarettes fall into the tobacco category more so than the pharm category if claims are not being made.

This all comes down to claims and unfortunately, the FDA made the assumption that the electronic cigarette is offered by one company and unfortunately, the company that made the biggest impression was a company that was making claims.
 

LoneRanger

Senior Member
ECF Veteran
Jul 18, 2009
227
0
Florida
Lone--they may not claim it, but that does not mean that this is not its "intended use" under the guise of the law. The "intended use" can and will be imputed by the Court if it is found that people use NJOY to quit smoking for a "healther" alternative.

One would be hard pressed to argue that that is not in fact what we all are doing.

Sun
If it says on the box & in manual committed smoker Does that mean Ill stop? I don't think so.
 
Status
Not open for further replies.

Users who are viewing this thread