Testing: What else is needed and how much will it cost?

[TropicalBob]

A few more thoughts on why we should take off the rose-colored glasses. This was a definition of e-smoking I posted last February, I believe it was:

"What we have today is an unregulated drug delivery device being sold at low cost to anyone over the Internet, a device that uses highly poisonous liquid sent by parcel post in leaky glass vials, a device made in China by companies that defraud customs with phony content invoices and value declarations, a device with a single purpose -- sustaining an addiction in the addicted or creating an addiction in the curious."

That definition still holds true.

And I think the ruling of the Food and Drug Administration on nicotine lollipops and lip balm in 2002 could apply to our carts, liquids and devices:

"Today FDA issued warning letters to three pharmacies that are selling "nicotine lollipops" and/or nicotine "lip balm" over the Internet. The letters inform the pharmacies that FDA has found their nicotine lollipops and lip balm to be illegal. Based on statements from the pharmacies' Internet sites, the products are promoted as aids for smoking cessation or to treat nicotine addiction.

"FDA is concerned about the health risk of these products because they appear to be compounded and dispensed without a doctor's prescription, contain a form of nicotine that is not used in FDA-approved smoking cessation products, and because these candy-like products present a risk of accidental use by children."

In further explanation of the ban, the FDA wrote:

"The claims on the websites include that the products help alleviate the "hand to mouth fixation" associated with smoking and are a "convenient, tasty way" to replace the cigarette habit. After investigating and carefully assessing these websites, FDA has determined that the pharmacies' nicotine lollipops and nicotine lip balm are intended for use as "drugs" and appear to be illegal for the following reasons:

"They are compounded and dispensed without a doctor's prescription.

"They are unapproved new drugs which need, but do not have, FDA approval.

"They are made from a drug substance, nicotine salicylate, which is not permitted for use by pharmacists in compounding drugs. The FDA-approved smoking cessation products are made from different forms of nicotine.

"They are misbranded because their labeling does not have adequate directions for the uses for which they are being offered and does not have adequate warnings against use by children.

"FDA is requesting a response from the pharmacies in writing within 15 days of receipt of the warning letters stating the action the firms will take to discontinue marketing of these drug products. Failure to do so may result in further regulatory action, potentially including a seizure or injunction action. FDA will take appropriate action to protect the public health."

And ... bam! ... these items became a footnote to smoking history. 15 days later they were no longer available.

Not one word from the FDA about making smokers healthier with a safer alternative. Not even a consideration. Bam! Banned.

See any sentences here that might be applied to our drug delivery devices and solutions? Sorry to say, I do.

[riddle80]

I want my glasses back TB!!!

I know these are all possibilities for worst case scenarios, but what is our best case? Looking at these lists it seems as if there is no hope for these wonderful inventions.

Keeping on doing what we're doing now obviously isn't going to work forever. At the least I'd imagine the liquid bottles need some serious upgrading (warning labels, exp. dates, better caps, ingredient lists). I read in one thread that in the future all liquid will be sealed in disposable cartridges (no bottles) so children and pets can't get into them (also to prevent od on nicotine).

Aside from being banned and safety, another big concern of mine is affordability. The price of e-smoking/vs regular smoking along with the benefits makes it perfectly poised to take over the tobacco market and save smokers money which in this economy is golden. From what I gather if the FDA sees it as a quit smoking device the price would go waaay up. I tried to quit w/Nicorette a few years ago and I remained addicted to the nicotine. The cost was so much more I had to go back to regular cigs.

What a sick and twisted system we have! Profit and greed are above human consideration and quality of life . I don't understand why cigarettes that kill so many each year can continue to be legal when "nicotine lip gloss" is banned. We've all taken the bait and became hooked on these cancer sticks, now why won't government accept and embrace safer affordable alternatives? Population control?? BS!! Even if e-cigs aren't perfect now, the idea and invention is amazing and modifications should be made to make them better. They might not be able to market these as a quit smoking device, but I've never found anything better to quit! I'm "replacing" my nicotine through a different source, but I've quit tobacco with ease. It's unbelievable how easy it's been! Both of my aunts have died from smoking. Both were unable to quit till it was too late. My aunt that passed away this year smoked until she had to be hooked up to life support because she couldn't breathe. My other aunt smoked one last cigarette the day she died even though she couldn't eat or drink. I've seen first hand what these things can do, and as much as I've wanted to quit I haven't been able to until now. My 50 year old mother who was smoking 2 packs a day has almost quit in less than a week with these. She was well on her way to be exactly where my aunts were. This could very well add many years to her life.

It makes me mad to think just because big tobacco/big pharmaceutical co. has a strong competitor these could be flushed down the drain, or that government would shut it down to keep the population in check/make money off taxes. Where are the morals? Sorry to rant, but this is very upsetting to me.

Great posts and information everyone!

[spyderuk]

What a sick and twisted system we have! Profit and greed are above human consideration and quality of life . I don't understand why cigarettes that kill so many each year can continue to be legal when "nicotine lip gloss" is banned.

Quite simply put, it's due to the amount of tax the goverment is raking in from it. But hey everyone knows that.

Lip gloss and lollipops is pushing it a bit though imho.

As E-smoking becomes more mainstream it will be brown trouser time for the big tobacco companies as well as the goverment. Would it be easier for them to ban e-cig's, liquid etc or to control and tax it?

Profit and Greed for the fat goverment cats every time.

I remember reading an article many years ago regarding smokers and the NHS. They were complaining that smokers with smoking related illnesses are a strain on the NHS system and why should they get treatment? Considering the extra taxes they have paid through their addiction, why shouldn't they be treated?

[TropicalBob]

I worry too, Riddle80. The real hope rests with clinical trials that show these are safe personal vaporizers. Not e-cigs. Not cigarettes at all. Personal use vaporizers.

As for our industrial foes: Big Pharma can offer liquids that contain nicotine but also IMPROVE health. Big Tobacco can demand only American nicotine from American-grown tobacco be used. That might remove both as opponents. China can be shut out for all but the devices (the UK and US can't compete with their labor). Government can, and likely will, tax each product we use.

Don't compare e-smoking to tobacco smoking. Tobacco has a glorious history, from the very first journey of Columbus to the Americas. Tobacco products are grandfathered into laws. If a cigarette were new today, it wouldn't stand any chance of approval -- tax or no tax. It would be banned in a flash. Because of its history, that's not an option.

What we e-smokers are advocating is recreational use of an addictive drug labeled a "toxin" by the FDA. That's it in a nutshell. It's a tall order. Nicotine is otherwise used legally for three things: regulated and approved methods to help smokers quit, not sustain, addiction; special medical concerns addressed only by doctors; and insecticide, which is off the market in the U.S. We are not NRT and can't afford the process to be NRT. And we aren't for bug killing, although if a roach soaks up our e-liquid, it'll be four-legs-up in a few minutes. We hope the same doesn't happen to us down the road.

[Kate]

I can see restrictions/controls/bans on liquid nicotine, that isn't a stretch of the imagination. I don't think there is a case to ban or control the hardware though, so we could still satisfy the habit part of smoking with flavoured zero nic eliquid and get nic from another source such as snus, NRT or something else.

[deewal]

Surely we in the West must now have all of the different parts of an e-cig and must know how to make one ? Likewise with the Liquid. Somebody must have figured out by now how it's made?
If we can do that then we can carry on using them whether it's illegal or not.
There are more illegal cigarettes in Scotland than there are legal ones.
Likewise Whisky. The Stills in the Glens have never been busier.
FREEeeeeeeeeeeeeeeeDom.

It's only following the Government's example. (Illegal War's etc)
I could give you a list with more than Ten illegal things our Government are doing.
I have no respect for our Government or Laws. I hold them both in Contempt.

[jackie_UK]

This is a brilliant thread that deserves to be read by every forum member in order to make sure that we all understand ALL the issues relating to the use of e-cigs (which, in the light of posts, might better be referred to as e-vaps !).

I would personally like to especially thank TropicalBob for taking the time to itemise his 10 points as requested. Fascinating reading and spot on. Being in the UK, I have to translate references to FDA to the UK equivalent, but the issues remain the same. Thanks also to those of you who have added to TB's list.

When the '..... hits the fan' we need to get someone (or persons) in a position of authority (who might be able to influence future government/medical/commercial actions) to read this thread and realise what the implications of e-smoking are - they probably would not be able to anticipate all the issues we are faced with anywhere else. This could be an important step towards starting to overcome all the objections. Knowledge (and understanding) is strength. Do such persons exist ? It might be easier for an 'e-vaper' to go into politics. Er...TropicalBob, do you fancy a change of direction ? Anyone else ?

Until then, I for one will vape away and wish I understood electronics to enable me to make my own gadget(s)...lucky those of you who can !

[TropicalBob]

I'm far too blunt to be a politician, Jackie. What I have tried to do is influence some researchers and manufacturers, so e-smoking is not derailed during its startup run. I believe these things have incredible potential if allowed to evolve.

Even forums like this have influence. Someone in Big Pharma and Big Tobacco reads Google references to our topic! These people don't contribute to forums, but they take from them. So, Big Pharma, you already sell devices containing approved nicotine. Would a liquid product for a personal vaporizer be difficult to create and sell? Hardly. And, frankly, I'd trust YOU far more than any Chinese manufacturer.

And I note that Nicorette gum now "whitens your teeth" as you chew. Good move. Snus companies in Sweden are adding teeth whitening material to their products. Several snus products now contain caffeine and other energy boosters (think of a Red Bull of snus!). You could add approved medicines and let doctors prescribe individually targeted nicotine/medicine liquid for smoking patients who could benefit from this inhalation therapy treatment. This could be a boom market beyond the $14.9-billion you expect to make on existing NRT products in the next five years.

And Big Tobacco needs to expand products that smokers will flee to as the no-smoking noose tightens. E-smoking devices are one option. Big Tobacco is already into chew and snus and dissolvables. Vaporizing devices are not a stretch; Big Tobacco, in years past, has tried the Eclipse, Premier and Heatbar. None worked well. Try a Janty Kissbox! That one works!

There is light at the end of this tunnel. There are also dead-ends that fraudulent advertising and unregulated products will lead to. Long, long ago, I suggested we never reward irresponsible companies with our monies. I hold that to be truer today than ever. Read this forum and you'll learn the White Hats among the quick-buck Black Hats. Buy from the White Hats as if your future depended on it. It does. Black Hats provide all the ammunition the anti's need to ban us. Shun those sellers like the plague they are.

[Lithium1330]

I can see restrictions/controls/bans on liquid nicotine, that isn't a stretch of the imagination. I don't think there is a case to ban or control the hardware though, so we could still satisfy the habit part of smoking with flavoured zero nic eliquid and get nic from another source such as snus, NRT or something else.

Initially they can ban anything, even the hardware, the goverment of my country (Mexico) did it in a blink! they can use any kind of argument to ban the hardware if they want to.

While i was reading the thread some questions pops into my mind, why the FDA hasnt ban the e-cigs yet like in the case of the lollypops? this is weird, maybe they are in their way to ban this.

The only real options i can think about are that the big pharma companies or the big tobacco companies creates their own devices for vaping and their nic-liquid to feed those devices, this could be a good thing since we gonna use a well regulated safer drug than we do now, but the prices gonna be higher.

But we have another option, LEARN, yeah, this gonna sound crazy but if we as a community learn how to setup our own devices, and learn how to produce safer liquid for it, even without the nicotine element, we gonna be far away from any regulation, law, ban, greed or any monetary interest, lets think about it as a GNU, open source, creative commons, etc project, i can see madog discovering the easiest way to make an atomizer and attach to this a big fat battery pack, i can see him selling the parts, manuals and tools for a DIY vaporizing device, I can see kate selling her recipes for a good flavoured liquid with a big production of vapor, and I can see TBob selling manuals and intruments for a save way to extrac some nicotine directly from tobacco.

How could this happen? with KNOWLEDGE, a study could be spensive, we can think that these studies most be done by the principal persons and companies involved and making money from this invention, but we can create our own invention and run our own studies for every aspect of it (with the help of some university or some institution like that), not for a FDA aprove, but for our own use of this knowledge.

If we just stand out and wait for the future, its very probable that this things gonna get banned in a lot of countries or the big pharma/tobacco companies will take charge of the bussiness, so lets do something, lets start our own development team, lets make the foundation of our own open source project.

Maybe we could even save some lifes, the smoke adiction is a really big killer, but there is more involved than nicotine or tobacco in this adiction, maybe we can start this without using nicotine of any kind and from any source.

So, Who is interested? who could contribute to this project? anything is helpful, and perhaps we are NOT sending rockets to the moon, how hard could it be? lets start small and see what happens.

[TropicalBob]

Let me say that I read the French position on e-smoking only about an hour ago, and it surely answers Kate's question. What French authorities say is: If the device contains nicotine, it must be classified as a medical device -- requiring lengthy study and an approval process. If it doesn't contain nicotine but is for quitting smoking, it is still a medical device with the same restrictions. If it's not for quitting and contains no nicotine, it's okay.

And that's how our devices can be banned.

An e-cig would be useless to me without nicotine.