FDA Zeller on E-Cigs: It's Complicated

[Kent C]

Almost 5 years of hard work to force the industry to either improve cartomizers or to get away from that burning filler...

http://www.e-cigarette-forum.com/fo...8-4081-etc-filler-type-cartos.html#post300790

.... to all there. Some gone but not forgotten.

 

[Katya]

.... to all there. Some gone but not forgotten.

Yeah...

Well, if the FDA has its way, we'll be back in business again. We know exactly what to do... Now where did I put my dremel and my exacto knives?

 

[Stosh]

Almost 5 years of hard work to force the industry to either improve cartomizers or to get away from that burning filler...

http://www.e-cigarette-forum.com/fo...8-4081-etc-filler-type-cartos.html#post300790

It got me to switch to CE2's and never looked back....

 

[aikanae1]

The problem is, there is always going to be experimenting - by teens and adults - they'll never get rid of that subset - a true subset that they're interpreting at the 'whole population level' (which it isn't) - yet they're staking everything on the idea that they can. They're willing to let the hardcore subset die, in order to try to save those they can't control.

This is a main 'lie' that we have to refute. Zeller is truly stuck on it. And again, it's the 'public good' argument. I know people don't like me conveying it, but he's the one who is saying it - I'm just pointing out what he said. Were it not for that, he seems more than willing to save the hardcore smokers. But for him, that trumps all.

I know it doesn't make sense to us, but I think this "public good" standard is significant and without substantial changes, no nicotine product will be approved for "recreational" use. Only as a treatment (medical) use. In 4 words, Zeller said "nicotine is a drug". But the misleading lies and fraud shoveled towards other gov't / public health officials and press is inexcuseable.

 

[Katya]

It got me to switch to CE2's and never looked back....

Here's a fine example of an SE product--e-puffer? smoke 51?

 

[Bobbilly]

Yeah, I saw you other 7 posts And heard it from the horse's .... mouth, at the hearing.

Yeah I'm a bit excited. I'm trying to spread the word. The UK seems to be all over ecigs in a positive way

 

[Katya]

I know it doesn't make sense to us, but I think this "public good" standard is significant and without substantial changes, no nicotine product will be approved for "recreational" use. Only as a treatment (medical) use. In 4 words, Zeller said "nicotine is a drug". But the misleading lies and fraud shoveled towards other gov't / public health officials and press is inexcuseable.

Yes, but that horse has already left the barn, or has it?

 

[Bobbilly]

I know it doesn't make sense to us, but I think this "public good" standard is significant and without substantial changes, no nicotine product will be approved for "recreational" use. Only as a treatment (medical) use. In 4 words, Zeller said "nicotine is a drug". But the misleading lies and fraud shoveled towards other gov't / public health officials and press is inexcuseable.

The same study from the UK addresses the fact that the numbers trying e cigs are mostly those who already smoke. And are consistent with those numbers of youth who take up smoking each year.

 

[aikanae1]

Not really. What makes a substance a controlled drug? I hate saying it, there has to be something else, but why don't they consider caffine a "drug" too - or do they but haven't taken it under control yet? Why not alcohol? Is tobacco a "drug" too? Where is that line drawn?

There isn't a clear cut relationship to "drug" and risk or harm.

 

[Katya]

Not really. What makes a substance a controlled drug? I hate saying it, there has to be something else, but why don't they consider caffine a "drug" too - or do they but haven't taken it under control yet? Why not alcohol? Where is that line drawn?

But what does it matter now? They are not going to challenge the Sottera ruling. They can't. It's been 4 years.

 

[Kent C]

Here's a fine example of an SE product--e-puffer? smoke 51?

And in 'comments' I may just say something along the lines, if you think cigalikes are the answer, take a look at this thread.... link

 

[Kent C]

But what does it matter now? They are not going to challenge the Sottera ruling. They can't. It's been 4 years.

And even if they did, then we're all addicts and they might have to provide SSI and something 'substantially equivalent' to methadone....something that reduces harm but continues the addiction. Let's see, say something like... electronic cigarettes! lol And health care will cover it. Oh wait... smokers are demonized and .... users are victimized. Damn.... that won't work. :-(

 

[Katya]

And in 'comments' I may just say something along the lines, if you think cigalikes are the answer, take a look at this thread.... link

I wouldn't just give them a link to the thread.

Too many... frivolous posts...

 

[aikanae1]

But what does it matter now? They are not going to challenge the Sottera ruling. They can't. It's been 4 years.

Maybe it's too late for this. I thought the Sottera ruling said 'as long as there were no theraputic claims' well, alternative to smoking isn't a theraputic claim It just seems like the FDA is still trying to apply a medical standard to a non-medical, tobacco, non-theraputic product.

The reality is this isn't going to be a popular arguement anyway. I think that's ultimatley what's going to win or loose.

 

[aikanae1]

Aren't ecig's considered medical devices in the UK? If so, then they don't have this same, stupid "public good" standard that the FDA is attempting to apply. "Public good" means the product has to prove things like not getting in the way of someone attempting abstence, or kids experimenting. It's an impossible standard.

 

[Katya]

I have a feeling that we're heading back to court, eventually. Let's just hope we'll get somebody like Judge Leon again. Or a really sharp lawyer. Preferably both.

E-cigarette is a tobacco product now. Zeller may resent the ruling, but the ruling stands. So he just wants to deem. But it's still going to be a tobacco product--and as long as cigarettes and cigars and chewing tobacco are legal, I don't see how they can make e-cigarettes illegal. The rest is fine print and years of expensive litigation.

 

[Bobbilly]

Well I believe he's going to be on the wrong side of history on this one. I could understand it when it first came out. But now they are doubling down.

 

[Katya]

Aren't ecig's considered medical devices in the UK? If so, then they don't have this same, stupid "public good" standard that the FDA is attempting to apply. "Public good" means the product has to prove things like not getting in the way of someone attempting abstence, or kids experimenting. It's an impossible standard.

Electronic Cigarettes

No therapeutic claims are permitted since this implies a medicinal function and an MA would be required (a pharmaceutical license). Therefore, if e-cigarettes are marketed as a smoking cessation aid, they must be licensed as a medicine by the MHRA, Medicines and Healthcare Products Regulatory Agency, a regulatory agency within the Dept. of Health (this functionality is considered medicinal). The MHRA has served enforcement on rogue traders who marketed their products as a smoking cessation aid.

As a smoking alternative, however, e-cigarettes are a consumer product and unrestricted by medical and tobacco control legislation.

 

[nclobo]

Translation: "The research doesn't say what we want it to, therefore it doesn't exist."

It may not exist today, but the FDA is willing to spend quite a sum of money to get those results it's looking for.

DURHAM: Triangle research will help guide new e-cigarette regulations | Local/State | NewsObserver.com

The science that’s expected to eventually add muscle to the bones of the e-cigarette regulations has become nothing short of a small industry here financed by more than $80 million in grants and contracts...

Dr. Adam Goldstein, Director of the UNC School of Medicine’s Tobacco Prevention and Evaluation Program is also involved:

“It looks like they are really being comprehensive, and they are basing it on science but also that they understand this is not a simple process,” Goldstein said. “So, at least from a public health framework, there’s a lot to like here.”

The needed research on things like flavorings, he said, is clearly on the way.

Goldstein, is very pro-Pharma so I would not expect a very favorable outcome for e-cigs in his research. You can read more about his views on e-cigs here:

Doctor: E-cigarettes don't help smokers kick habit :: WRAL.com

The FDA's chosen researchers is worrisome to me.

 

[2coils]

I know it doesn't make sense to us, but I think this "public good" standard is significant and without substantial changes, no nicotine product will be approved for "recreational" use. Only as a treatment (medical) use. In 4 words, Zeller said "nicotine is a drug". But the misleading lies and fraud shoveled towards other gov't / public health officials and press is inexcuseable.

You are right! That is the sticking point. E-cigs don't fit in. The FDA and BP DO NOT want an alternative product. In their mind, the consequence is less people "quitting". Less people using approved methods. This is ALL resistance due to philosophy rather than substance. Those who have switched have not quit (in their mind). It is still the quit or die mentality as far as I'm concerned. E-cigs keep us on nicotine, they don't want that. The perfect storm is already in place! smoke,, then NRT, smoke then NRT.........with e-cigs involved, its NO smoke and NO NRT. They will lie and cheat to defend this!