Why shouldn't the FDA interfere?

[TropicalBob]

I'm sorry to have flown off the handle in this discussion. Everywhere I look today, it seems doors are slamming shut. The economy. Newspapers dying. And my beloved e-cigs in imminent danger. It's damn depressing. I'm .. touchy right now! Sorry I took it out on you, Disman.

There may be outside influences that determine the outcome of e-smoking. If there are, we are not privvy to that knowledge. Trog is likely correct with his blunt assertion that if an agency wants to ban e-cigs, they will find a reason. If they don't, we're in.

But I think much hinges on the "what is an e-cig" question. It's an electronic device that looks like a tobacco cigarette and functions as a substitute for one, whether the objective is quitting or simply enjoying an alternative. It was designed to deliver nicotine to those wanting it. The patents say so. So the FDA -- in its own words -- says the e-cig is a drug device.

The drug is nicotine. The formulation used is unapproved, making it a "new drug". But nicotine is used in NRT to treat a medical condition called nicotine addiction. Thus any device that delivers nicotine to addicts is a "medical device" and thus requires testing, review and approval by the FDA.

Just as a company can't dump a new drug on users without following approval guidelines, a company also cannot just start marketing a new medical device.

So that's our problem. Yes, we can say a screwdriver can be used as an ice pick, but that's not its purpose. That's not in its definition. Marketers have done us wrong from the very beginning. They have sold e-cigs as cigarette-like devices to get us off tobacco by delivering us nicotine, sometimes even advocating WHO's step-down practice. The marketing has backfired.

Now let's have discussion on how we get the FDA to see e-cigs as anything other than drug delivery devices. Personal vaporizers? It's a start.

 

[Nuck]

There is NO chance the device itself will be banned. If the government had the power to do so, the endless supply of drug toys would be long gone.

The idea that anyone would be silly enough to sell it as a nicotine delivery device after a ban beggars the imagination.

I think the doom and gloom from all your other issues is clouding your judgment. A lifetime of watching the government grind it's teeth while we merrily flaunt our other electronic vaporizers is pretty telling.

Get juice...and lots of it then sit back and enjoy the show.

 

[TropicalBob]

I sure would like to share your optimism on the devices, Nuck. I keep coming back to the FDA's first paragraph in notices to suppliers:

Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action.

The words "medical device" have been used in discussions in other countries, as well. It all depends on how these are defined. Toys? Or medical devices? What should be argued?

 

[LaceyUnderall]

There is NO chance the device itself will be banned. If the government had the power to do so, the endless supply of drug toys would be long gone.

I agree with you 100%. And TB knows how I feel about the quoted statement from the form letter. Those devices that were stopped were also accompanied by written documentation that stated they were quit smoking devices OR they were labeled as medical devices like a lung apparatus or a nebulizer. If I were in customs, I would have stopped them too.

 

[Nuck]

My Volcano isn't sold as a weed vaporizer which is why I can legally buy it, they can legally advertise it and I can (not quite so legally) use it whenever I get a bit stressed.

The Volcano has one real use and that's to vaporizer an illegal drug. Far worse than nicotine in most governments eyes. They may not like it, but they can't ban based on an assumption of use.

The nic juice is the real issue but given how easy it is to produce bootleg, the government finds itself in a bit of a bind. They can try to prohibit it, but that will just create profit for those willing to bend the law. On the other hand, they could legalize it, regulate it and tax it.

I'm quite confident I know which way it ends up.

 

[Kate]

If liquid nicotine solution intended for inhaling became a controlled substance, what sort of restrictions and regulation would it face?

Regarding the debate about the ethics of bans, I agree that something should be available to an informed public unless and until found harmful.

BUT ... The World Health Organisation says this:

"... the burden is on product sponsors to satisfy regulatory agencies and to ensure public health institutions that their products are safe (and effective if such claims are made) - not on WHO or regulatory agencies to prove all aspects of potential harm when there is a plausible basis for harm."
*E-Cigtest, the ultimate electronic cigarettes review site* - Le site de la cigarette électronique - View Single Post - WHO - Marketers of electronic cigarettes should halt unproved therapy claims

Is there a 'plausible basis for harm'?

 

[Nuck]

The WHO has far more influence on poorer nations. Western nations tend to decide for themselves based on what is political expedient at the time. Most will use WHO statements to support whatever legislation they pass if the legislation happens to coincide with a WHO position.

During the SARS epidemic, the WHO were forced to backpedal on quite a few statements after political pressure was applied. It was from that point on that I concluded the WHO was about as credible as the WTO.

The cost benefit to every western nation with socialized medicine is enormous. There is a common misconception that cigarette taxes are a boon to these governments. A quick check on the cost of smoking vs. health and social costs (you can google your own governments websites, I know Canada publishes the data) shows there is a staggering deficit.

I strongly believe that governments, after collecting peer reviewed studies on the health risks involved with ecigs, will not only legalize it, they will actively promote it.

The nicotine juice will probably be blocked for a period of time while the government(s) works out the endless quality and safety issues involved so again, I recommend a really good supply of juice.

 

[Kate]

Politics aside, if that's the thinking at WHO it's not a big stretch of the imagination to think that some governments will take that view.

Will proof of safety be required by the FDA or will lack of evidence for harm be enough?

Is there a 'plausible basis for harm'?

If eliquid became a controlled substance what would that mean in regard to US law and availability?

 

[Nuck]

The WHO has a mandate and motives that are quite different from those of a western government. If a government did come to the same conclusion, then I suspect 'plausible basis for harm' would likely be used to support a position as opposed to a legal criteria for arriving at one.

The final decision will, in most countries, be based on the social and economic costs given all available data. All the discussions revolving around 'big tobacco and big pharm' lobby pressures doesn't really apply outside of the US.

As an intellectual point of discussion, I doubt we have the background or the current research to debate what constitutes a 'plausible basis for harm'.

 

[TropicalBob]

Yep, those are good questions but we do not have sufficient information, as Nuck says, to debate what's "plausible".

I do think "proof of safety" will be required in the States. All indications are the FDA already views these negatively, has indeed said they are illegal to sell or market, and will eventually halt selling of any e-smoking product without proof of safety.

I think the present group of happy e-smokers is as close as we can come today to proving e-smoking is harmless in the short term. Beyond that lies the unknown.

 

[b00stzx3]

My Volcano isn't sold as a weed vaporizer which is why I can legally buy it, they can legally advertise it and I can (not quite so legally) use it whenever I get a bit stressed.

The Volcano has one real use and that's to vaporizer an illegal drug. Far worse than nicotine in most governments eyes. They may not like it, but they can't ban based on an assumption of use.

The nic juice is the real issue but given how easy it is to produce bootleg, the government finds itself in a bit of a bind. They can try to prohibit it, but that will just create profit for those willing to bend the law. On the other hand, they could legalize it, regulate it and tax it.

I'm quite confident I know which way it ends up.

Maybe this is off-topic, but from what the local "tobacco" shop said here, Homeland Security had something to do with the ban on importing Volcanoes into US. Don't know how true it is, but the price went from 500 to 800 relativley quick

 

[tpboles]

drug-device combinations

I'm not sure if the ecig "device" would be a problem to the FDA. Seems like the problem was the ecig device coupled with nicotine cartridges.

Am I reading into that wrong T-bob?

 

[Nuck]

Maybe this is off-topic, but from what the local "tobacco" shop said here, Homeland Security had something to do with the ban on importing Volcanoes into US. Don't know how true it is, but the price went from 500 to 800 relativley quick

Just do a quick search on volcano vaporizer. It's all over the place.

 

[TropicalBob]

TP, I can't say. And I don't think anyone can say with assurance what the FDA position will ultimately be on this. Wish I knew -- I'd stock up on atomizers instead of just liquid.

Canada is supposed to issue some kind of statement this month, and if it goes beyond a judgment on liquid, then we'll have a clue on how the U.S. might view these. I do think the present liquid situation is untenable, indefensible. Devices? Another story.

 

[skex]

Here's the reality check.

Every regulation that exists that was not put in place at the request of industry to create barrier to competition (which frankly represent most) you know the things that the corporate lobbiests and the GOP are .....ing about when they talk about over regulation.

Everyone of those came about because private companies didn't behave responsibly in the first place and some tragedy took place that caught the public ire. Congress wasn't jsut sitting around bored one day and say "gee I think we should pass a law saying that companies have to have fire exits that are able to be opened so their workers can keep from burning to death" No a bunch of ****ing workers burned to death (in this case a bunch of women seamstresses who were working in a factory where management had chained the exits so they couldn't sneak out of work) which resulted in a ...... off populus and a bunch of elected officials getting up on their soap boxes and bloviating about some feel good measures.

The best hope for e-smoking is for it to fly under the radar long enough that it becomes a fait acompli from a regulatory standpoint. Meaning that it's been around long enough that the politicians will catch enough heat for baning it to stay the regulatory hand.

Right now it's pretty much doing that. The press it's gotten so far has been relatively positive. Most people are sympathetic to smokers at this point particularly after all the bans have gone through and are getting a bit tired of the Anti's nonsense.

Also government usually moves at the speed of a glacier there is limited funding and frankly as long as there isn't some great public outcry about E-smoking it will most likely be left alone for some time.

However the first time some kid chugs a bottle of 24mg cherry E-juice that's all going to change. You can bet the anti's are going to be over that incident like fly's on ****. They have the media connections and funding to get the story out. Suddenly the coverage will shift from "Safer alternative to smoking?" to "Puffing Poison".

Now the best way to deal with this is for we consumers to demand better quality control and best safety practices from our supliers. If the industry self regulates effectively the government won't step in because they have bigger fish to fry.

So from this day forward I'll only be getting my liquids from suppliers who provide proper packaging. I suggest we all do the same.

Suppliers need to understand that a small additional investment today (the cost of which they can frankly pass on to us) may save their livelyhoods in the future.

 

[Sun Vaporer]

TP, I can't say. And I don't think anyone can say with assurance what the FDA position will ultimately be on this. Wish I knew -- I'd stock up on atomizers instead of just liquid.

Canada is supposed to issue some kind of statement this month, and if it goes beyond a judgment on liquid, then we'll have a clue on how the U.S. might view these. I do think the present liquid situation is untenable, indefensible. Devices? Another story.

TB-- I concur. The present liquid situation is in fact "untenable" indeed. You have, what is and will be perceived by anti-groups as, "poision in a bottle" with little if any information on dosing. Will the FDA mandate regulations like any other OTC such as Tylenol? Just take a look at a bottle of Tylenol or any other OTC drug--Warning lables containing dosing, interactions, contratictions, phone numbers for questions, etc. All the requiste infromation--some of it common sense, others pertinent. The point being that any argument against regulation of some type for a substance like nicotine liquid is a tough one at best.

Over the last 60+ days we have scene manufactures like Johnson Creek, Totally Wicked, etc step up their efforts by labeling their ingrediants and giving prudent warnings, including empoying childproof bottles--Is this enough for the FDA? Is the FDA going to want to see testing, quality control, and regulated mandates of nicotine content limits? To think that the FDA is going to look the other way on a substance like nicotine is a little too naive, as we witnessed with Nicotine Water.

As for the device itself, again that is a hard sell, but maybe--and that is a big maybe, that the FDA might allow that to slide. If Suppliers would stop the false claims as many of them have, their might be a slight chance there--but I think that is wishful thinking on my part--I try to look though the prism and see the many arguments on both sides, and from my vantage point I contend that thinking that there will be no regulation of our devices, is at best a blinding view. Agencys like the FDA always prevail on any argument where saftey is the issue. It is very plausable that the FDA will in fact call our devices "medical drug delivery systems" and mandate regulations for them as well--I hope not.

When and what the overall scope that the FDA will mandate is really the only questions left--big questions indeed for people like us looking to stay away from a known killer like cigarettes---Sun

 

[b00stzx3]

Can't we market it as something else? Don't people use those VCR cleaners to get high? Especially gay dudes? Label it nicotine incense or somethign along those lines.

 

[taukimada]

Can't we market it as something else? Don't people use those VCR cleaners to get high? Especially gay dudes? Label it nicotine incense or somethign along those lines.

that comment prolly just brought you a flaming

 

[Kate]

.....

 

[Nuck]

Sun, I understand you are pessimistic, but what exactly do you base it on. I can't for the life of me think of a single time when hardware has been banned, even the hardware that is obviously used for illegal activities FAR worse than nicotine.

Call it a personal vaporizer and detach it from the nicotine and it's untouchable. I guess I just don't see what precedence your grim outlook is based on.