How about an Application?

**Sun Vaporer** · 03-13-2009, 08:12 AM

Originally Posted by markab

Hi Brian,
As optimistic as I am about e-cigs there has been no long term studies on its safety. With TCs (traditional cigarettes) I suspect there wasn't anyone who got lung cancer after smoking them for only a few years. We need e-cig manufacturers to act now and get more health studies started. It's a little late, but better late than never.

Mark

Mark, you are right on point--I do not see these manufactures ponying up here and getting the Clinical Trials and Studies needed to be ready to make an application with the FDA if that becomes necessary. Maybe they have enough consumers right in China and really do not care--What a shame as they have the profit margin to do as many studies as they would like to fund if they wanted them done--makes no sense---Sun

**Kamanjah** · 03-13-2009, 08:59 AM

Originally Posted by MonkeyMonk

stpeters thank you so very much for the link and the information about vitamin B6. I hope everyone takes the time to fill out the petition to prevent Big Pharma from patenting naturally occurring substances. B6 saves diabetics from kidney failure. How could the FDA do this??? And now they might take away the other naturally occurring formulation of B6. So, pleas if you read this go to this link and take the time to fill out this petiton to stop it.
https://secure3.convio.net/aahf/site...rAction&id=245

Thank you!!!

Is Big Pharma going to patent Nicotine next?

Thanks for posting the petition/letter link. I said my piece in addition to their letter, pointing out that people will have to see a doctor, insurance companies or Medicare will have to pay, as will the patient! Then they'll get a prescription, and again, insurance companies or Medicare will pay their part, and patients will pay more too. Same with weight loss supplements. Declaring weight loss claims as disease claims will send just send more people to doctors. This will just raise costs for everyone. This can't possibly be the right thing for health care in this country!

Just one more way to screw things up! Nic patches used to be prescription only and the insurance companies didn't want to pay, so it became an OTC item. Now the FDA wants to reverse OTC items and send people back to docs and prescriptions?

The insurance companies will fight that!

I think Ms. Chappelle voiced a personal opinion because when asked a specific question about whether the FDA was cracking down on the sale of our devices, she basically said it was an open case and she could make no further comment. In other words, she mouthed off and then played CYA!

And, as far as customs is concerned, our devices are classified within existing codes and will be passed if properly coded and subject to a 2.6% duty. That's pretty darn clear IMO!

Hopefully this is much ado about nothing!

**MikeMac** · 03-13-2009, 09:25 AM

JC is still sending supplies. I would bet that they will be one of the first to receive any actions. Hopefully they will post here to let us all know.

I just placed an order with them today for 3 bottles and they have already shipped out. So far so good.

I plan to dilute (ala Kate's methods) the high down to med, low and finally zero. Then I will hopefully get along just fine without the nic content. PG, VG, flavor and water. No harm in that!

The government will save you from all potential pitfalls in life. Cradle to grave = control. Too sad.

Those Who Sacrifice Liberty For Security Deserve Neither. ~ Benjamin Franklin

**Sun Vaporer** · 03-13-2009, 06:33 PM

Originally Posted by Kamanjah

I think Ms. Chappelle voiced a personal opinion because when asked a specific question about whether the FDA was cracking down on the sale of our devices, she basically said it was an open case and she could make no further comment. In other words, she mouthed off and then played CYA!

And, as far as customs is concerned, our devices are classified within existing codes

Ms. Chappelle is head of Media Relations for the Drug Division of the FDA. She was called by the Reporter and specifically asked to do her job--release and clairfy information on the FDA's position. Her comments where on the record and very clear. She does not get paid to give her personal opinion and if you read any of the numerous links posted on this thread, you would see that she is a "heavy hitter" that makes very calculated statements on the record. Her statement that:

"It is illegal to sell or market them, and the FDA is looking into this,'' said Rita Chappelle, an agency spokeswoman.
Asked if that meant the FDA would crack down on the dozens of mall kiosks nationwide where the product is being sold like perfume and cellphone covers, Chappelle said: "This is an open case. Beyond that I can not comment.''

should be talken at face value. The only issue now is how broad the scope of the FDA action will be---Sun

**Brian** · 03-13-2009, 08:52 PM

Still scratching my head.....
Last night I was reading some old excerpts from the tobacco laws. From what my feeble mind could gather, BT is permitted to continue selling cigarettes with tight restrictions, but the law prevents any new competiters from emerging, and to prevent anyone from developing and marketing a "safer cigarette." Anybody attempting to make that claim will be immediatly stopped and open a slaughter of investigations and further selling will be deemed illegal. (basicaly keeping anybody from competing with BT and the drug companies) Which brings us to our current issue.... however may not be as dramatic as we think....I think she is techinally right for saying it is illegal (for the rocket scientist and the company for selling them as a stop smoking aid) but for everyone else promoting e-cigs as a smoking alternative has nothing to worry about... or am i wrong in this assumption?

**Sun Vaporer** · 03-13-2009, 08:58 PM

Originally Posted by Brian

Still scratching my head.....
Last night I was reading some old excerpts from the tobacco laws. From what my feeble mind could gather, BT is permitted to continue selling cigarettes with tight restrictions, but the law prevents any new competiters from emerging, and to prevent anyone from developing and marketing a "safer cigarette." Anybody attempting to make that claim will be immediatly stopped and open a slaughter of investigations and further selling will be deemed illegal. (basicaly keeping anybody from competing with BT and the drug companies) Which brings us to our current issue.... however may not be as dramatic as we think....I think she is techinally right for saying it is illegal (for the rocket scientist and the company for selling them as a stop smoking aid) but for everyone else promoting e-cigs as a smoking alternative has nothing to worry about... or am i wrong in this assumption?

Brian --good post. The nicotine is the issue and constitues a drug just as it did in the plight of Nicotine Water. Will the actual e-cig itself be considered a delivery system for this new "drug"? Does the "drug" need to make formal application with the FDA and provide the requisite studies?--these are questions that are going to get answered in the near future---Sun

See http://www.nicotinewater.com/

**Kamanjah** · 03-13-2009, 09:08 PM

Just my opinion, but if it was actually illegal to sell and market them, why would the case still be open and she can't comment further? Why would customs be allowing properly labeled shipments that are obviously for resale into the country?

**Brian** · 03-13-2009, 09:11 PM

I never knew nic water was ever offered... that is really neat... heathy, fit and toked up all in one healthy shot... LOL... if only there was a way an every day joe could have a device that could vaporize.... oh nevermind (laughing)
but I can see why the FDA has kinda been avoiding the whole prospect of regualtion in the first place...I think it scares the crap out of them as much as it does us

**Sun Vaporer** · 03-13-2009, 09:17 PM

Originally Posted by Kamanjah

Just my opinion, but if it was actually illegal to sell and market them, why would the case still be open and she can't comment further? Why would customs be allowing properly labeled shipments that are obviously for resale into the country?

The FDA has not acted yet--hence customs has no guidence. Once the FDA acts by way of a mandate, then Customs will have a clear directive as to what to do ---Sun

**poeticwomyn** · 03-13-2009, 09:28 PM

Well as I posted on another thread (and MHO remains unchanged which is more than we can say for the flip-flopping of over politicians )IMHO, seems to me that e-cigs are something that "sneaked in the back door" while the government wasn't looking. So now there is going to be a lot of media hype and scare tactics put through the media until some control legislation is passed. Because, good grief, no way can a full grown adult human make their own choices about what is good for them with out some govenmental legislation over it. I am new to e-smoking but absolutely love it as an alternative to cigarettes. But I do believe that if it doesn't get very popular very quickly we (as e-smokers) will not have a collectively loud enough voice to stop legislation that will, at best, dictate where and when I can buy and use my supplies or, at worst, ban it all together. The other thought this brings to mind is the fact that they are not getting tobacco taxation money on this product. Also with being in a medical related field for over 30 years, I don't believe any of the government agencies will be happy unless there is a total cessation of tobacco use. Humbly voicing an opinion, Kat