The battle is already lost.

[Boston George]

So I will say, I am no fan of the FDA. I am a small government kinda guy. Recently, I googled "FDA banned " to see some other cases where the FDA has banned a product. I expected to find a collection of sketchy diet pills and other things that are clearly less than healthy.

The first gem I stumbled on was Stevia. A natural sweetener.

This is an article about a company that fought, and lost to the FDA.
Stevia Cookbooks Banned by FDA, The Stevia Story

Now clearly they are biased. So I went to Wikipedia to get a better understanding. Stevia - Wikipedia, the free encyclopedia

Some really great quotes:

Since the Japanese firm Morita Kagaku Kogyo Co., Ltd. produced the first commercial stevia sweetener in Japan in 1971,[13] the Japanese have been using stevia in food products, soft drinks (including Coca Cola),[14] and for table use. Japan currently consumes more stevia than any other country, with stevia accounting for 40% of the sweetener market.[15]

In 1991, at the request of an anonymous complaint, the United States Food and Drug Administration (FDA) labeled stevia as an "unsafe food additive" and restricted its import. The FDA's stated reason was "toxicological information on stevia is inadequate to demonstrate its safety."[53] This ruling was controversial, as stevia proponents pointed out that this designation violated the FDA's own guidelines under which any natural substance used prior to 1958 with no reported adverse effects should be generally recognized as safe (GRAS).

Arizona congressman Jon Kyl, for example, called the FDA action against stevia "a restraint of trade to benefit the artificial sweetener industry."

Stevia remained banned until after the 1994 Dietary Supplement Health and Education Act forced the FDA in 1995 to revise its stance to permit stevia to be used as a dietary supplement, although not as a food additive — a position that stevia proponents regard as contradictory because it simultaneously labels stevia as safe and unsafe, depending on how it is sold.[55]

And the icing on the cake

n December, 2008, the FDA gave a "no objection" approval for GRAS status to Truvia (developed by Cargill and The Coca-Cola Company) and PureVia (developed by PepsiCo and the Whole Earth Sweetener Company, a subsidiary of Merisant), both of which are wholly-derived from the Stevia plant. [56]

That coupled with the recent ruling by the supreme court that implies FDA approval does not mean safety.

"powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness."- Justice John Paul Stevens

Sighting that the "limited resources" for overseeing the more than 11,000 drugs on the market prevents the FDA from doing its job.

I am not going to say that the FDA is the most useless and corrupt agency in the government. Clearly, completely, under control of the major drug companies.

But I ask you,

-If they cant grantee our safety?
-If they clearly stifle free markets in favor of the bigger players?

What good are they?

 

[Vape]

If it benefits a supplier who's importing to the US or the consumers buying the product, yet threatens their "funding" sources, why the hell would the FDA allow such a thing! The funding from taxpayers is pretty much a gimmie, but the money from the drug companies is what lines their pockets.

 

[Vapor Pete]

Off topic:
vape... I love your avitar
My best,
-VP

 

[syntaxevasion]

yeah, that is a tight avatar...

 

[Lorddrek]

Sad to read but it really plots the course thru what many seem to feel are uncharted waters. To see the future one only needs to look at the past...

 

[deewal]

Just google Aspartame & Rumsfeld if you want to see how the FDA and The US government work.
If we were not seeing this happen with E-Cigs now you would dismiss it as an Internet Conspiracy Theory.

This is good as well.
http://www.vegsource.com/davis/sweeteners.htm

 

[Relentless]

Thus far I have yet to see the FDA do ANYTHING but ask for the exact same things they ask of every other consumable product wished to be marketed... then sold in the U.S.
All this whining and complaining about how they hate the product is the epitome of immaturity.
The manufacturers or resellers.. or ANY#$@@*&@^BODY needs to follow the rules no matter how valid we all know the product to be.
Hint:
Manufacturer/Reseller! Get a friggen lawyer and do what he/she tells you.
Make the appropriate submissions.. applications... pay for the testing and try your damndest to kill the test rats...
Submit results to the FDA and presto effin poof here you'll have either a yes or a no.

The only reason there is a supposed ban is because this has yet to happen.

And relax everyone, until this happens we'll still be able to order our wants from China as long as it is modest orders... Ordering a seventy-two tonne shipment of nicotine juice might catch an eye.. so keep the orders just under that.

 

[incineradma]

I know the FDA is messed up, but for one there is a slight positive side-effect to them being "funded" as it were, in that America retains its resources (money.. ).. which might be a good thing considering our economy right now. But still.

US could easily manufacture these things, and make money. I don't think the FDA would be against that as they were against a product that was being imported. And aren't there already companies manufacturing these?

 

[bebop]

the US could maufacture these yes, but who will do it is the entity which has the most power, influence and money to break the FDA wall down. so this will be the tobacco companies, and the powerful tobacco lobby.

but the thing is that the e-cig is already manufactured in China, and that is where it would be manufactured if it was legal anyway because it's the cheapest in the world.

I agree with you that the jobs created from this new niche market should go to US citizens, but it won't if big tobacco gets ahold of it.

 

[bebop]

The thing is that e-smoking seems impossible to control. Too many places in the world can make good money off this invention, and it can be constructed DIY, and FYI the entire world is bankrupt so someone, somewhere will profit from manufacture. So I think if the FDA suceeds in prohibition of PV's they guarantee a black market, and also risk people doing greater harm by DIY nic extractions, and would be complicit in supporting an invisable money trail and resultant drug traffiking. Bearing in mind that cigarettes are leagal provided you aren't a minor, the banning of e-cigs seems groundless.

I just don't believe that the FDA has the resources to single handedly "shut it down"

 

[JustPuffin]

Manufacture in the US at this time is improbable. Bootlegging would be a more appropriate description. For years my wife and I were in the health food industry. When we decided to manufacture the FDA inspected the facility for cleanliness, the label had to meet the FDA requirements, product liability insurance had to be obtained, etc. To do this properly would be a herculean task. It can be done, but I don’t see it any time in the near future.

 

[dagit]

the US could maufacture these yes, but who will do it is the entity which has the most power, influence and money to break the FDA wall down. so this will be the tobacco companies, and the powerful tobacco lobby.

but the thing is that the e-cig is already manufactured in China, and that is where it would be manufactured if it was legal anyway because it's the cheapest in the world.

I agree with you that the jobs created from this new niche market should go to US citizens, but it won't if big tobacco gets ahold of it.

I'm glad to be able to contradict the notion that it's cheapest to manufacture these products in China!

After months of research, work, meetings, contemplations, etc. we received the designs for a vastly improved e-cig model this last week, and next week will start manufacturing the prototypes for testing. It'll still take a bit of testing with tweaks here and there, but this new model addresses many of the quality control and technical issues e-cig users have struggled with and best of all - can be manufactured locally (ie: Canada/USA) at a fraction of the manufacturing cost for what we've been getting out of China.

Over the next couple weeks we'll be finalizing the business structure and financial model, and then share what we're at with the rest of the community with the hope others will want to get involved too, but for now - the gist of it is that we intend to use this model to start jumping through the regulatory hoops needed to get the electronics approved as a "medical device" in Canada and the USA, while concurrently using it for clinical trials of the nicotine liquid.

Obviously there's a lot of work ahead and none of this is a short term solution to our needs or a guarantee on what the future holds, but it's a myth that e-cig users are exclusively reliant on overseas manufacturers for any reason.

It's not like the only thing North Americans can build are cars and wood-framed houses!

 

[TropicalBob]

Good for you. Look forward to more information as your venture progresses.

 

[esmok-e]

It's not like the only thing North Americans can build are cars and wood-framed houses!

Amen! This device, while ingenious and a 100% SAFER AND HEALTHIER CIGARETTE (there, I said it), is not rocket science to produce cheaply and of high quality - it's the regulatory hurdles that present the financial impediments. And that includes the patents from Mr. Lik and Tobacco companies - they are already in place. Legal fee$, legal fee$ and more legal fee$.

So if it does get out of the hangar and on to the taxi ramp it may never even see the runway. The missiles are pointed right at it (heat seeking for 350 degrees fahrenheit nicotine vaporization) and the Control Tower will call the shots. Watch your six Alpha-Bravo....

 

[Boston George]

Thus far I have yet to see the FDA do ANYTHING but ask for the exact same things they ask of every other consumable product wished to be marketed...

The point is that the sub components of the e-juice are all GRAS. If big pharma had said hey we want to sell this, the FDA would have given it a 'no contest' add to the GRAS list.

But now the FDA is taking the position that even without nicotine, its a drug. Hell, without nicotine its a fancy bubble blower.

 

[esmok-e]

Hell, without nicotine its a fancy bubble blower.

A fancy bubble blower with legs and wings....

 

[dagit]

Amen! This device, while ingenious and a 100% SAFER AND HEALTHIER CIGARETTE (there, I said it), is not rocket science to produce cheaply and of high quality - it's the regulatory hurdles that present the financial impediments. And that includes the patents from Mr. Lik and Tobacco companies - they are already in place. Legal fee$, legal fee$ and more legal fee$.

So if it does get out of the hangar and on to the taxi ramp it may never even see the runway. The missiles are pointed right at it (heat seeking for 350 degrees fahrenheit nicotine vaporization) and the Control Tower will call the shots. Watch your six Alpha-Bravo....

Admittedly, it's been the image of those missiles pointing at my head that's given me the most pause over the last few months. For my part, personally, anyway - the rest of our small group aren't such wusses. I had to really dig into things before I was willing to be a target for the next few years!

Regulatory hurdles to get approvals in place will be the key part. Legal fees are only a piece of that too - the average cost per subject of a stage III clinical trial is $26,000 here in Canada, multiply that by the few thousand+ subjects required, and ouch!

Good ol' Mr. Lik isn't a worry though - neither he nor the Chinese manufacturers as a whole have swallowed up the talent pool of innovation. What our engineers have designed is not only vastly superior to the e-cigs we've come to know and (mostly) love, but also represent a vastly different technology. For example, imagine your current e-cig without any wires connecting the components and the refillable carts that don't rely on "cotton-type" substances to soak up the liquid.

Anyhow, none of this represents a solution to the short term problem we're facing and none of this is guaranteed for the long term either. It's not only a risk, it's a big risk. There isn't just one challenge or one hurdle, or one "force" that will push back. There's many of them, large and small, from gov't agencies and existing policies, to wanna-be "rescuers of man" who call themselves civil servants and spent their lives coming up with new policies to legislate our collective behaviour, to the non-profits that need smokers as a target for their campaigns, to uneducated smokers and non-smokers alike who just can't get over the fact what they "know" is really just an opinion not supported by common-sense, to tobacco companies, to... well, we all know this already.

So, do we give up now, accept the fact we're "bad" smokers, and go back to the holes we've allowed our non-smoking peers to dig for us, or do we try to push back, collectively, and fight for our basic human right to do everything possible, access every resource possible, to pursue and preserve our health?

 

[esmok-e]

Put me on your resellers list.

 

[dagit]

Put me on your resellers list.

Actually, what we really need are some bodyguards.... 8-o

 

[LaceyUnderall]

dagit - great idea and definitely keep us all posted on your progress.

But back to George's initial topic: There are two differences here in comparison to Stevia and those are the users and the tobacco industry. First, users. The ecig is gaining enough traction that an all out ban will cause some serious backlash. I for one will not go gently into the night (and not because I am a supplier). The ecig has saved me from a lifetime of tobacco additive addiction. So, I plan on being vocal if said day ever comes.

Second: The tobacco industry. The tobacco industry has had pretty much unadulterated control over nicotine delivery and been able to deliver nicotine in any way they see fit. The delivery system they have perfected is extremely dirty and they have in turn, demonized not only smoking, but nicotine to some. They have created a very bad public persona and if we align our ecigs as a comparison to them, then we are in the winning light. Only those who have stripped the additives out and gone the other route, pharmaceutical, have been allowed to play ball. Those days, need to be over and I think it is very possible that the FDA could look at it from a tobacco harm reduction perspective.

If they are given control over tobacco, it is reasonable to lobby to have alternative nicotine delivery systems regulated differently than they have thus far. Make the requirements and standards for public health for cleanliness and safety, but don't require clinical trials and provide some time for these products to be used by the public. The users are either going to smoke tobacco or this. Let them smoke this. And anyone who fights against this, is purely in it for money or control and not health and can FINALLY be called out for what they are!

There is absolutely no doubt that the ecig is a cleaner delivery for nicotine than tobacco. It doesn't take a clinical trial to prove that and the FDA needs to release their pharmaceutical regulations on alternative nicotine delivery.

And as far as each of the ingredients in our stuff being FDA approved, you are right. I openly dare the FDA to tell me I cannot smoke legal substances. I also, stand from the side that the FDA cannot tell me how I should medicate myself. The government certainly doesn't help me with my health insurance and if I believe 1/16th of what I hear, I am on my own in late age so if I choose to self medicate with a little nicotine instead of taking a pharmaceutical that will help contain my PMS, then that's my business, not theirs.