Why is the PV not a quit-smoking device?

[thewomenfolk]

I don't quite understand why these PV's can't be advertized as a quit-smoking device. That's what it was for me, over-night, so to speak. No more tobacco, tar, arsenic, or even nicotine (well, mostly), for me. They advertize the patch or gum as quit-smoking devices, and they sure do contain a lot of Nicotine. But they're not outlawed. Somebody help me understand.

 

[Porphy]

It's all about wording and use. Right now there are nicotine replacement therapies (NRT's) and smoking alternatives, as far as I am aware there are no quit-smoking devices. These devices are labeled and marketed as smoking alternatives because they haven't been approved by the FDA as nicotine replacement therapies. To market a product as an NRT you need FDA approval. There has only been sporadic testing on the devices ability to wean people off of cigarettes and even less on its ability to be used as a nicotine cessation device.

No amount of anecdotal evidence will convince the FDA that these work. They need manufacturers/suppliers to submit the device and liquid for testing and pay for it out of pocket. For now we call them smoking alternatives because they have yet to be approved, by the FDA's standards and through the FDA's means, to be effective as such. You can see what happens when the FDA does their own testing instead of testing done by a neutral 3rd party.

For now they will remain marketed as smoking alternatives and we, as consumers, have the right to use them however we deem acceptable. If we choose to use them to sustain a healthier nicotine habit then that is our right. If, on the other hand, we use them to reduce our nicotine intake until we no longer need nicotine... that is our right as well.

 

[rjp44]

I don't think any of the resellers and manufacturers in the U.S. are big or rich enough to jump thru the FDA hoops. They approve Chantix which takes at least 30 seconds of listing side effects including suicidal thoughts in their commercials, but Pfizer has deep, deep pockets and it all boils down to money talks.

 

[Porphy]

Big Pharma can also use the power of lobbyist that our local small fry guys can't. The lobbyists put pressure or bribe the government officials who in turn put pressure on the FDA reps.

If you for one second believe that our government works on anything other than a monetary system then you're mistaken. History alone disproves the democratic theory, but everyday practice cements the fact that those few with the deepest pockets will have their interests served.

 

[catwoman19]

Big Pharma can also use the power of lobbyist that our local small fry guys can't. The lobbyists put pressure or bribe the government officials who in turn put pressure on the FDA reps.

If you for one second believe that our government works on anything other than a monetary system then you're mistaken. History alone disproves the democratic theory, but everyday practice cements the fact that those few with the deepest pockets will have their interests served.

OH MY GOSH, are you saying that the FDA is bought and paid for? Well, I never

 

[Angela]

Additionally, 'quit-smoking' aids (ie NRTs) are intended to be short-term use and you are supposed to wean yourself off the nicotine in that time. They are really 'quit nicotine' aids, which is not the intention for many people using the e-cig.

 

[thewomenfolk]

So do I understand that the FDA has tested and approved the nicotine patch and gum as NRT (nicotine replacement therapies). But when the FDA tested Njoy (Smoking Everwhere?) they claimed to have found substances they couldn't approve, so they denied the PV the NRT status? Is that correct?

 

[Angela]

Not quite: the FDA does not usually do the testing, but drugs do need to go through a testing period / clinical trials, which the manufacturers usually do. They then make application for FDA approval and submit the results of their testing / trials in support of that application.

As manufacturers argue that e-cigs / liquid are not a drug / drug delivery device, they did not do trials / testing and did not make application to the FDA.

The FDA tested some Njoy and SE carts to support their argument.

Patches, gum, etc have had testing / trials done, have gone through and received FDA approval as an NRT. E-cigs have not even attempted this (and, IMO, should not as they are not NRTs for the reasons stated in my previous post)

 

[logivap]

some people simply enjoy using them as an alternative. If they are an anti smoking device that would severely limit what companies could do.

Many people enjoy vaping and it's simply an added bonus to be healthier then analogs.

 

[HaploVoss]

Many people enjoy vaping and it's simply an added bonus to be healthier then analogs.

*raises hand*

Although I have entirely quit smoking *tobacco based* cigarettes. I thoroughly enjoy my electronig ciggies and don't have any plans to stop in the near future. 80% of my work is in front of my PC. I like to walk down to the river by my house with my wife. We both just enjoy the relaxing, tasty, pleasurable facets of vaping. Simple. Yeah the nicotine parts are cuz we got hooked on cigs back in the day, but we're adults now and it's our choice to smoke, so it ought to be our choice to vape IMHO. We LIKE it!

Take care,
- Hap

 

[thewomenfolk]

Thanks Angela, I'm beginning to understand, I think. But I don't see how the e-cig manufacturers can say their PV's are not drug delivery devices, unless nicotine is not considered a drug. (My PV is not a nicotine delivery device for me, but it's a choice, and with cigarettes there's no choice.)

 

[Angela]

It's to do with the definition of 'drug', and this is why it's all in the courts at the moment.

There are certain 'drugs' that are socially acceptable / used legally by millions: alcohol, cafeine, nicotine....... but 'drug' in the pharmaceutical sense is something that is used to treat a medical condition. NRTs are considered drugs because they 'treat' nicotine addiction. PVs (IMHO) do not treat this condition, they are merely a substitute for traditional cigarettes (and this view is borne out by the fact that polls on this site have shown that most PV users do not intend to 'give up' vaping).

 

[Kate51]

There is a stop smoking "device" called Nicotrol. It is just what it says, they were first let out in prescription only, and you have so many "cartridges" to get yourself weaned from nicotine. Fine. They had the right idea, but the nicotine level was so low to begin with, the "smoker" started the whole program off with wildly fluctuating withdrawal symptoms that it was plain doomed to failure from day one. FDA approved. Same with patches, same with gum and suckers!
The e-cigs came out advertised as a stop smoking device as a "calling card" for people who wanted off cigarettes. My opinion, that's a valid sales point. Only problem, they don't specify any established "program" of stopping smoking, so right away the FDA gets on the band wagon, because now the user can use all the nicotine they want, and wants to call is something else, and nicotine delivery system. So Big Pharma jumps in and all the "WHO's" and ASHES came out and said Yeah, what's this, these things don't get people away from nicotine, these things are a lie, we have to stop them!!! They're ruining our business and interfering in our mandates!! We gotta make nicotine a drug. So they did it. Oh, yes, throw Big Tobacco in there too, made them look good!! We're gonna make cigarettes "safer".
So now it's too late for the ecig companies to go do it over, calling them anything else now is moot, the fight is on now between no nicotine and no cigarettes battlegrounds.
Words do mean something. That's why it's such a slippery slope now trying to keep them from being banned outright, which would be disaster for us. It would create another "underground" supply system, the same type of system that the Marijuana started. Had MJ been further tested I do believe that we'd be buying it over the counter today, just as we do tobacco cigarettes. But in the 60's it gathered too much unattractive "in your face" steam that was unacceptable to "normal" people. So the bad things about it and the abuse it inspired over-ruled any chance of finding the good things about it, potentially. We'll never know if it could cure cancers, for example. Some people say yes it can. But Big Pharma could never get a "handle" on the crops, it was out of their hands too fast. The aspirin avoided all that as a commercially available OTC pain reliever, because Big Pharma got ahold of the bark on that tree first. See what I mean? Because it's fed Big Pharma some nice big income for a lot of years now. Billions of dollars worth. The Little Bitty Aspirin wins!!!
Tobacco products, not so much. I do believe E-cgs and juice can prevail, because there's billions of dollars in sales to China involed here. Hmmmm...wonder if they can get this stuff "FDA" approved...stand by...

 

[Mac]

In order to claim cessation, you must prove that not only will a certain percentage of people who use your product stop smoking tobacco but will ultimately stop using your product as well. E-cigs exist so that we don't have to stop. They are intended for long term use. Thusly not eligible for cessation category.

 

[Kate51]

In order to claim cessation, you must prove that not only will a certain percentage of people who use your product stop smoking tobacco but will ultimately stop using your product as well. E-cigs exist so that we don't have to stop. They are intended for long term use. Thusly not eligible for cessation category.

Exactly right Mac, now it's a "drug delivery system"...whoo, I'm getting a headache! It really just depends on who wants what, and who does it first! Gosh, I hate politics. Don't forget, China does "practically" own us, so maybe.....well, like I said, stand by...

 

[ECS-Mike]

I don't quite understand why these PV's can't be advertized as a quit-smoking device. That's what it was for me, over-night, so to speak. No more tobacco, tar, arsenic, or even nicotine (well, mostly), for me. They advertize the patch or gum as quit-smoking devices, and they sure do contain a lot of Nicotine. But they're not outlawed. Somebody help me understand.

Without reading the other responses that may have already explained this..

From my take on this, they can't be advertised as a quit smoking device because there has been no testing as to whether or not they can actually help you stop smoking. That is what the FDA is using as part of their 'attack' on e-cigs.

However, to me it would seem logical that if gum with nicotine in it, and nicotine nasal spray are considered cessation devices because the replace the nic delivery method and allows the person to do this by 'stepping down', then there is no logical reason as to why an PV is in any way different. The only real legitimate issue I see is there is no regulation on standardization.

I have tried some PV devices that come with nicotine levels of 'high' that are weak at best, and i've also tried some 'mediums' that make you break out in a sweat with a noticeable spike in blood pressure with a small pull. Its hard to call them a device that allows you to step down and then quit a nicotine addiction when nicotine levels from product to product is a crap shoot.

Though what I dont understand is why they can't be just a smoking device. Not everyone is trying to quit smoking, some just want a variety and something easier on their lungs/throat..etc.

So my question is why can't they just be a smoking device? I can go down to the corner smoke shop and buy a 6' tall polished brass 'tobacco pipe' with 4 surgical oxygen masks hooked to air pumps to keep a constant stream of 'tobacco' coming to me and thats not considered a "medical device" by the FDA. So I dont get how the little battery operated PV's are considered more substantial than the shelves full of hand blown glass from artisians in other countries.

 

[freaknormal]

If PV's are advertised as a quit smoking device, that is considered making a health claim and then must be regulated by the Food and Drug administration. Since the FDA already has it out for us because this product could bring an end to the tax dollars brought along by tobacco sales, they will surely find a way to ban it by making bogus claims about how it is just as bad as cigarettes, or that it can't be regulated, or that it's marketed to children because of the flavors, etc. . . (all of these rediculous claims have been made buy the way). It is simply advertised as "smoking alternative", it does not make any claim to cure any disease or be a medical device in any way shape or form like patches and gum are. This leaves the public open to do the research themselves and make a determination on what they would rather do. (No Brainer)