Cigarette or Drug

[LaceyUnderall]

Originally Posted by TropicalBob

Halopunker is right. Quest was a step-down system to zero nic, provided by tobacco especially grown by the Amish (since Big Tobacco put the clamps on any other farming of such a product). It's a great story, BTW.

But a smoker gets all of the damaging tars and their carcinogens and none of the nicotine addiction satisfaction. I used all three Quest products and fell apart when the nicotine was removed or diminished. My case might be unique to me -- but it did NOT work. Neither will these silly cigs.

What's interesting is that they (the OP they) want to seek FDA approval for use of their cigarettes in conjunction with the current NRT's which I believe right now, is strongly warned against due to nicotine overdose complications. And, as you have noted, it has already been done before... Sheesh.

You are right. It is totally silly considering there is already a product on the market, the ecig, that does what all of these other companies are trying to do... re-enact the hand to mouth.

Either way, it is still combustion so I just don't see how a nicotine less cigarette that burns is going to be good for anything. I guess just another misunderstanding of basic smoking science 101 which is that it is the combustion that is truly harmful... not the nicotine.

[TheBoogieman]

<< But a smoker gets all of the damaging tars and their carcinogens and none of the nicotine addiction satisfaction.>>
So its the exact opposite of an ecig. Where do we sign up for that?

[IANAN]

Herbal cigarettes (Non-Tobacco) have been on the market for over a decade... They typically are treated as tobacco products (Taxed and regulated as such) ....

As I understand it these are GMO tobacco with ultra ultra ultra low Nicotine. Nevertheless it is funny that they are passing these off as NRTs.

[rothenbj]

Originally Posted by ckc

Now this is confusing, the next NRT up and coming is a cigarette?

22nd Century Continuing Development Of Its Smoking Cessation Aid

I'd honestly like to know how that will be remotely acceptable.

Okay, let me calm down a bit. I used to smoke Marlboro Reds a long time ago. Then I switched to Marlboro Ultra Lights believing BT's spin. Then the researchers and the FDA came out with the FACT that the Light and Ultra Light cigarettes were no better and PERHAPS WORSE that full flavored cigarettes since the smoker would smoke deeper and more (which probably had some merit).

Now a company comes along and tells me they're developing a cigarette with even less nicotine and it's going to be more successful than current NRT's in helping smokers quit? Am I freaking missing something here?

Point 1.

Point 2.

This Investigational New Drug Application (IND) investigation was led by Dr. Dorothy K. Hatsukami, Director of the Transdisciplinary Tobacco Use Research Center, University of Minnesota Cancer Center.

She happens to be the co-author of the report brought up yesterday under the heading Presence of the Carcinogen N'-Nitrosonornicotine in the Urine of Some Users of Oral Nicotine Replacement Therapy Products


Irina Stepanov, Steven G. Carmella, Anna Briggs, Louise Hertsgaard, Bruce Lindgren, Dorothy Hatsukami and Stephen S. Hecht


This is the report that nicotine from NRT therapies increased NNN levels in there control group, indicating that nicotine may increase risk.

It is strange to me that the report on nicotine came out on Oct 20th and this new cigarette gets reported October 28th. When did the FDA do their dog and pony show on e cigs, months after they got their report?

What's a person to believe?

[rothenbj]

Originally Posted by LaceyUnderall

Interesting. So these cigarettes as NRT's are still going to burn? Isn't it the burning that is harmful?

Wow. There are SO many implications to this and routes this could go... I kind of fear for the FDA "approving" this cigarette. It opens the door for many tobacco cigarettes being FDA approved.

22nd Century Ltd., LLC - Technology Here's more on the actual product idea from the company

A bit off topic, but a continuation of a point I was trying to make to Sun in another thread.

"Research studies demonstrate that very low nicotine ("VLN") cigarettes, also referred to as "nicotine-free" and "denicotinized," are an effective tool in smoking cessation because they (a) relieve cravings for and withdrawal symptoms from conventional cigarettes and (b) extinguish the reinforcing value of smoking by breaking the association of sensory and behavioral cues of cigarette use with the rapid delivery of nicotine (Gross et al. 1997; Rose 2006; Donny et al. 2007)."

This product was developed in 1997 and at some point between then and 2006 they started doing studies. It's 2009 and they've just gotten to the FDA IND stage. How long will it take to bring this product to market (if it ever clears)?

How long would it take E cigs in some form?

[IANAN]

Originally Posted by rothenbj

A bit off topic, but a continuation of a point I was trying to make to Sun in another thread.

"Research studies demonstrate that very low nicotine ("VLN") cigarettes, also referred to as "nicotine-free" and "denicotinized," are an effective tool in smoking cessation because they (a) relieve cravings for and withdrawal symptoms from conventional cigarettes and (b) extinguish the reinforcing value of smoking by breaking the association of sensory and behavioral cues of cigarette use with the rapid delivery of nicotine (Gross et al. 1997; Rose 2006; Donny et al. 2007)."

This product was developed in 1997 and at some point between then and 2006 they started doing studies. It's 2009 and they've just gotten to the FDA IND stage. How long will it take to bring this product to market (if it ever clears)?

How long would it take E cigs in some form?

It takes 7-10 years to get a new drug through the FDA approval process, unless fast tracked, if I recall.

[LaceyUnderall]

Originally Posted by rothenbj

How long would it take E cigs in some form?

IANAN's right.

And it all depends on how the FDA decides to handle it, in and if they do, which they will to some capacity. Many health professionals on our side tend to think that it would only take a year at the minimum to do clinical trials... if we get lucky and the FDA works with us. The reality of that is that is just the trial, not the analyzation of the data. The goal would be, if they are working with us, to allow the ecig to stay on the market for the two years it would take to trial, analyze and then approve.

That said, there is NO guarantee that the FDA would not have us go through the clinical trials and then approve it. (which I think clinical trial testing is BS anyways since we would be doing trials to get this approved as a cessation product NOT as an alternative to tobacco)...

[rothenbj]

Originally Posted by LaceyUnderall

IANAN's right.

And it all depends on how the FDA decides to handle it, in and if they do, which they will to some capacity. Many health professionals on our side tend to think that it would only take a year at the minimum to do clinical trials... if we get lucky and the FDA works with us. The reality of that is that is just the trial, not the analyzation of the data. The goal would be, if they are working with us, to allow the ecig to stay on the market for the two years it would take to trial, analyze and then approve.

That said, there is NO guarantee that the FDA would not have us go through the clinical trials and then approve it. (which I think clinical trial testing is BS anyways since we would be doing trials to get this approved as a cessation product NOT as an alternative to tobacco)...

I knew the answer. That was a rhetorical question to Sun. It could easily take more than 10 years in my experience and that is coming from a Pharma background. There are many more issues that would need to be addressed in any application to the FDA- type of E Cig (all these varieties would be looked upon as different delivery systems), E liquid type and certainly nic content, etc. Unless the FDA drops their stance that the E Cig is an NRT product rather than an alternative to smoking, I see no future. IMHO

[SKing]

Yes, that is correct. It will probably take over 10 years. But wait. The FDA passes the H1N1 in 10 minutes. We need to start an epidemic of some kind.

[LaceyUnderall]

Originally Posted by rothenbj

I knew the answer. That was a rhetorical question to Sun. It could easily take more than 10 years in my experience and that is coming from a Pharma background. There are many more issues that would need to be addressed in any application to the FDA- type of E Cig (all these varieties would be looked upon as different delivery systems), E liquid type and certainly nic content, etc. Unless the FDA drops their stance that the E Cig is an NRT product rather than an alternative to smoking, I see no future. IMHO

My apologies... from your posts... I should have known this was rhetorical...

Too much candy this weekend caused a little brain rot! LOL