Smoking Everwhere's new full page ad:

[ladyraj]

For those that just don't seem to get it....

Smoking everywhere is attempting to make the case that the e-cig is a essentially a tobacco product that is smoking alternative to conventional cigarettes. If the case can be made then e-cigs would be grandfathered in with their counterpart...cigarettes. Yet the ads that are popping up on the computer declare health benefits and cessation outcomes. The e-cig interests in the "adulterated" lawsuit are contending they have no desire to encourage people to stop using nicotine but rather, that individuals should have choice which cigarette to use.

Thus, the contention presented to the court is in stark contrast to the contention stated in the ads. This dichotomy of information is the equivalent to statements of cross purposes which is generally interpreted as lying, or at the very least deceptive marketing.

Truth is a relative thing...what is true to me may not be true to you. If a company is currently fighting in court to declare e-cigs a tobacco product that has no desire to encourage cessation of their product their ads should be congruent with their argument.

Or perhaps I misread the arguments in the smoking everywhere case...

Can anybody clarify?

 

[ladyraj]

"Isn't anyone else blown away by the fact that a company cannot make the claim that this is used for smoking cessation and/or is a healthier alternative to smoking even though it IS true without running afoul of "the law"? Does anyone else realize how utterly absurd this is?"

I for one am totally astounded by this fact, and was about to make an independent thread topic out of your statement content. When the FDA and the gov't knee jerk against something so amazing, while at the same time they allow and have subsidized tobacco, only leads me to believe that it's an insane system we live in. True should be true, and it should be stated out loud,,,the ducking on our parts, in itself, is a false admission that we think it is wrong. Let's say this more directly, "I went on e-cigs two months ago, after slipping off of a cold turkey system on tobacco cirarettes AGAIN. Since then I have vaped when I wanted the action of a cigarette, and have not slipped to a real cigarette, now vaping ZERO nicitene. HONESTLY, it's been the easiest system ever! Why deep-6 that feature? Politics maybe, but be careful because individual denials of truth telling is not good for the soul. How can out own government foster real cigarettes and deny the e-cigs, when the e-cigs immediately cut all tars and other numerous chemicals totally out, all ending in a wonderful result for so many people's health systems? This is loony-tunes and contradicting to "Protect and serve the American people!" Criminal is the best word I can surface. Scooter

If the e-cig states "truth" as you have articulated it then years of testing must be completed to demonstrate the harm reduction of the product. Curse politics if so inclined for the machinations required to keep our products on the market but always remember that it is merely ridding yourself of frustration and does nothing to help the cause.

 

[catwoman19]

A new method for drug delivery is what the FDA contends, not that nicotine is a new drug.

To call this a new drug delivery devise doesn't make it either. Doesn't the nicatrol devise do the same exact thing?

 

[jerrydon10]

I don't need studies to tell me that inhaling propylene glycol alone (or as the major carrier), a chemical that I had been inhaling in cigarettes for 40 + years; is better than inhaling it along with tar and 800 chemicals, many well known to be carcinogens.

Yes, PG is in analogs too. Common sense here, anyone?

Also, I will still be vaping long after the 120 day prognostication predicated in this thread is past.

How long has pot been illegal? How about moonshine? How much of either of those products do you want delivered to your door in the morning?

Besides, our modders have produced great ecigs that use off the shelf batteries. We know how to make our own juice and fill our cartridges. We now have two home-made attys that work!

I don't follow the law just because it's the law. what kind of brain-dead citizenry would that produce?

 

[ladyraj]

To call this a new drug delivery devise doesn't make it either. Doesn't the nicatrol devise do the same exact thing?

No, the inhalor actually submitted paperwork for pre-approval (and subsequent acceptance with the FDA) and demonstrated via actual studies how the inhalor was simular to existing NRT. Further, the Nicotrol Inhalor did not try to skirt the issue the device delivered a drug.

 

[ladyraj]

I don't need studies to tell me that inhaling propylene glycol alone (or as the major carrier), a chemical that I had been inhaling in cigarettes for 40 + years; is better than inhaling it along with tar and 800 chemicals, many well known to be carcinogens.

Yes, PG is in analogs too. Common sense here, anyone?

Also, I will still be vaping long after the 120 day prognostication predicated in this thread is past.

How long has pot been illegal? How about moonshine? How much of either of those products do you want delivered to your door in the morning?

Besides, our modders have produced great ecigs that use off the shelf batteries. We know how to make our own juice and fill our cartridges. We now have two home-made attys that work!

I don't follow the law just because it's the law. what kind of brain-dead citizenry would that produce?

True, I will probably skirt the law as well. I just don't see the plethora of suppliers risking everything for a few sales. Thus, the availability of resources will dry up and the users will go underground. Most of us are rebels at heart but there is a line in the sand that a lot of people may not be willing to cross. Breaking laws is one of them. I know I will not be brewing anything in my home, mixing flavors is one thing, extracting nicotine from plants I grew in my back yard is a tad inconvenient. By the time I have to work that hard for a fix of vapor...I'll give it up.

 

[jerrydon10]

By the time I have to work that hard for a fix of vapor...I'll give it up.

Not me. I'll always walk a mile for a Camel......

 

[premiume]

[FONT="]e-cigarette make because of lot of dathe of real cigarette. E-cig is specially made for those people who smoke more and more and this is for 18+ people. [/FONT]

 

[aditas]

It does not matter why and what it was made for. The e-cig producers make one undisputed claim. No smoke inhalation. A lot of people have managed to wean themselves off the nicotine as well. Others are happy with their addiction to nicotine. The problem is that a lot of people want validation from the FDA that the vapor is completely harmless, without realizing that such validation threatens the availability of current e-cigs.
There is no reason why these devices should be limited to current smokers. I believe that if a non smoker wants to take on this habit they should be free to do so. Just like I was when I took on the disgusting habit of cigarette smoking.

 

[Oliver]

Unfortunately they don't just make one undisputed claim - some of them make several (including the manufacturers). These include claims of safety and cessation. Neither claim is valid and shame on them for that.

The safety claims wouldn't be valid even if applied to recognised NRT products. Nicotine isn't safe for long-term consumption. It is likely implicated in a whole raft of medical problems such as thickening of the arterial walls, vasoconstriction , and issues within the central nervous system that modern neuroscience is probably only beginning to get a handle on.

The cessation claims, however, could be demonstrated with a longitudinal study involving several hundred people. But of course, even this type of study can be biased in the favour of the companies funding it - that is to say, nothing is proven with a clinical trial.

Respectfully, I have to disagree with Bob on the idea that clinical studies can prove the safety of a medicine. They cannot, and this is not a mere academic point.

Clinical studies operate by measuring objective outcomes (eg. the cessation of smoking) while also measuring side effects - both those that are expected, and thus the participant is prompted to report (so, perhaps, the irritation caused to the mucous membrane by PG), and those that are unexpected and spontaneously reported or observed in participants (eg.

There is a huge grey area in between predicted and spontaneous reporting of side effects during clinical trials which means that drugs have been allowed on the market, with side effects being reported only later on.

The most famous example of this is the sexual dysfunction caused by SSRIs. The effect was not observed in trials, principally because participants were not asked whether they were experiencing it. It is also believed that patients did not spontaneously report them because they were embarrassed, or did not make the link between their dysfunction and the drugs. Sexual dysfunction is now the primary reason for discontinuation of successful ssri treatment (although it's hard to define any treatment as "successful" that robs one of such a central component of human existence).

In the UK, Medicines and Healthcare Regulatory Authority runs the Yellow Card Scheme which encourages patients and doctors to report side effects they report while taking a drug.

So, what does this mean for e-cigarettes? Well, nothing actually. The fact is that the FDA is set up in such a way that once they declare a product to be under their jurisdiction, they have a series of procedures that the manufacturer must follow to have their product approved.

Is this right? I'm in two minds about this. On the one hand it would seem to provide patients and doctors with a relative level of confidence that medication they use has been evaluated to the best possible standard.

On the other hand, there are massive shortcomings with this system.

For one, the cost of bringing a new drug to market, coupled with patent laws means that vast swathes of generic drugs or un-patentable drugs with potential new-uses will never be brought to market, even though they are far superior to novel (ie patentable) drugs. The cost of trialling them is simply too great, and if the return of investment cannot be guaranteed, it just won't happen.

The system also locks out small, dynamic and inventive companies who cannot raise the resources needed to go through the process. Meaning that BP has an effective monopoly on drug research - and further that they decide on the diseases "worth" investing in.

Lastly (from me, anyway), it means that there is an atrophying effect within pharma reseach. I don't have the figures to hand, but the number of new pharmacologically active compounds discovered each year has steadily dropped since the 1950s. As a result older drugs have been re-patented in new forms, and marketed as superior - even though the medical evidence is lacking. In doing so, companies are able to register new patents to protect their market share for another 10 years or so (20 years total minus the 10 years it takes to bring a product to market).

For me, the question that Bob fails to address with his resolute allegiance to the law, is the philosophical one of harm reduction.

Presently, harm reduction is simply not acknowledged as a legitimate avenue of medical enquiry, by law. Now, if you believe it should be (as I do, strongly) - what should your course of action be? Or more to the point, what is your course of action?

The only course of action is to have the law changed, of course. And this is the only course of action that will see the e-cigarette lawfully for sale in the US. Unless the FDA chooses not to regulate.

Interestingly, I received an email from our trading standards forwarded by a UK supplier a little while back. They seem perfectly happy for e-cigs to be on the market, so long as the consumer is made aware of what they are buying and don't make any claims for safety/cessation.

 

[kristin]

It does not matter why and what it was made for. The e-cig producers make one undisputed claim. No smoke inhalation. A lot of people have managed to wean themselves off the nicotine as well. Others are happy with their addiction to nicotine. The problem is that a lot of people want validation from the FDA that the vapor is completely harmless, without realizing that such validation threatens the availability of current e-cigs.
There is no reason why these devices should be limited to current smokers. I believe that if a non smoker wants to take on this habit they should be free to do so. Just like I was when I took on the disgusting habit of cigarette smoking.

Aditas, you are preaching to the choir here. We all agree that we are adults and should be able to decide what we want to put into our bodies and that it seems no worse than regular cigarettes and people are quitting tobacco cigarettes, etc. People here agree with you - they are just trying to tell you that just because WE believe it doesn't mean that the FDA and government will leave us alone.

The problem is that none of us are government officials nor make FDA decisions. We have no control over what the FDA decides to tries to ban nor their reasoning behind it.

E-cigs haven't been officially classified as either a tobacco product or a non-tobacco product. They haven't been officially declared a drug delivery device or a recreational use device. The FDA has decided that these are nicotine delivery devices and they are the ones who regulate non-tobacco nicotine products. Companies like Smoking Everywhere and Njoy GOT the FDAs attention when they started claiming that e-cigs help you quit smoking. That makes them smoking cessation devices and those come under the jurisdiction of the FDA. If you're going to make claims without FDA approval, you better put a disclaimer on them saying "These claims have not been evaluated by the FDA." The FDA is arguing that they, therefore, have the right to regulate e-cigarettes. You can argue with them all you want, but it isn't going to change their stance - especially since Smoking Everywhere is STILL claiming that they help you stop smoking - without the required tests showing it to be true. The FDA doesn't accept just stories from people who have tried it. They want controlled tests in labs and written studies by scientists. WE are calling for that, but the FDA is IF you want tpo call them smoking cessation devices.

The only one who can tell the FDA to back off is a judge's ruling that they AREN'T drug delivery devices intended for smoking cessation and therefore the FDA has no control over their sale and use. But that won't happen if these companies continue to openly market them as smoking cessation devices without controlled, scientific testing.

The e-cig manufacturers would have been better off if they had just kept marketing them as ALTERNATIVES and made no claims that they help you stop smoking - even if they do. By doing that, they got the FDAs attention and caused all of the problems we are having now.

 

[kristin]

I agree that due process should take place, but only when needed. We have indisputable proof that tobacco products kill. PERIOD.
How bad can e-cigs be? Certainly not as bad as tobacco. I was born with a brain. I can figure that out for myself without having to wait for years of BS tests to prove what anyone with a brain knows already.

Lets face it. You and I both know that if the US was not a law suit society this wouldn't even be an issue. The concern is about money.

Listen to what you are trying to sell to non-smokers, though.

Try to see it from their side and understand why they take the stance they do.

You want them to blindly approve yet ANOTHER dangerous & addicting product to be marketed freely. Now people will have tobacco cigarettes AND e-cigs to be additcted to nicotine through. E-cigs may have less carcinogens and no smoke, but nictoine addiction is hardly "healthy."

It doesn't matter to non-smokers that they may be better than actual tobacco cigarettes. First off, that hasn't been proven in scientific studies. Secondly, nicotine isn't proven "safe." It has been shown to have adverse side effects.

Their viewpoint is, sure, we already have liquor and tobacco and fatty foods - why add yet another unsafe recreational way to use nicotine? If people want to get away from the harmful effects of smoke, they should use nicotine cessation devices. And if you want to claim e-cigs as successful smoking cessation devices, you better prove to us through approved methods that they actually do what they claim.

The FDA doesn't compare the safety of one drug over another when they make approvals - they base it on the product in and of itself standing alone. Just because e-cigs MAY be less poisonous than tobacco cigarettes isn't in and of itself a reason to approve them.

Look at it this way. Say someone invented a drink that gets you drunk, but doesn't cause liver disease like alcohol. Manufactureres start calling it a way for alcoholics and drunk drivers to "quit drinking" and have a "safer" alternative to beer. Do you think MADD will care that it safer for the alcoholic's liver, when it's still getting them drunk? Even if millions of alcoholics quit alcohol, their still addicted to something that gets them drunk - do you think the FDA will stand for the companies to say it's a cure for alcoholism, because it's not actually alcohol getting them drunk?

THAT is how the FDA and non-smokers look at e-cigs.

Now, PROVE that e-cigs help you quit smoking or PROVE that there aren't any harmful chemicals other than nicotine and it's a whole other story. But no tests (other than New Zealand) have shown that they aren't harmful. And New Zealand requires a prescription for them!

 

[dragonpuff]

Once again, very well put kristin!!

 

[aditas]

You want them to blindly approve yet ANOTHER dangerous & addicting product to be marketed freely. Now people will have tobacco cigarettes AND e-cigs to be additcted to nicotine through. E-cigs may have less carcinogens and no smoke, but nictoine addiction is hardly "healthy."

Yes why not? I highlighted the word freely. If you believe that nicotine addiction is hardly healthy and commissioned an organization like the FDA to check for "healthiness" I have no problem if you can make them mandate the use of labels warning of such dangers. What I object to is their power to ban the sale of the product.

 

[Oliver]

You want them to blindly approve yet ANOTHER dangerous & addicting product to be marketed freely. Now people will have tobacco cigarettes AND e-cigs to be additcted to nicotine through. E-cigs may have less carcinogens and no smoke, but nictoine addiction is hardly "healthy."

And further - it is currently completely unregulated, unlike tobacco. No provisions exist to prevent its sale minors - other than the prohibitive price.

 

[kristin]

Yes why not? I highlighted the word freely. If you believe that nicotine addiction is hardly healthy and commissioned an organization like the FDA to check for "healthiness" I have no problem if you can make them mandate the use of labels warning of such dangers. What I object to is their power to ban the sale of the product.

Object all you want - we all do - but it's a fact we can't change unless the judge rules against the FDA.

Like I said - you're preaching to the choir here.

How about you re-direct your energy to writing your legislators, newspaper editors and the FDA itself?

 

[PlanetScribbles]

I realise that you are right kristin. It just annoys the hell outta me and I sometimes vent it all at once. Like Yellowstone lol
The guns of the navarone and all that
Why do we need rules and regs? We got on fine without them for a few thousand years.

 

[kristin]

I realise that you are right kristin. It just annoys the hell outta me and I sometimes vent it all at once. Like Yellowstone lol
The guns of the navarone and all that
Why do we need rules and regs? We got on fine without them for a few thousand years.

Yeah, we all get that way on occasion.

Not true though, as soon as there were communities, we needed rules and regs. Without them, 7 year olds would still be working factories 16 hours a day and cars wouldn't have seatbelts and Coke would still contain .......! 8-o

So, some rules and regs are good!!

 

[aditas]

How about you re-direct your energy to writing your legislators, newspaper editors and the FDA itself?

I do kristin, I just don't get the feedback that I get here.

 

[PlanetScribbles]

Yeah, we all get that way on occasion.

Not true though, as soon as there were communities, we needed rules and regs. Without them, 7 year olds would still be working factories 16 hours a day and cars wouldn't have seatbelts and Coke would still contain .......! 8-o

So, some rules and regs are good!!

True, but it is taken to ridiculous extremes now. Back in the day, if it walked like a duck, quacked like a duck and swam like a duck, it was assumed that it was a duck.
Now it would have to be fully tested under strict laboratory conditions to make sure it was a duck