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]

Originally Posted by 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.

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.