Fda Classifying Ecig As Drug Product

[BEERCITYVAPRZ]

One week from today is the hearing! One week!

I know Im ordeing 300 to 400ml on monday and using it to get off of nic all together. Hope you are stocking up to QT.

[xandalis]

Okay people, just dug this up during preliminary research. I haven't read much of it yet, as it's 54 pages long, but I hope someone who's got more legal knowledge/training/education than I have (mine is based only on the basics you learn of CYOA in the military) will take the time to read it over.

FDA Enforcement and the Constitution: The Validity of FDA Seizures under the Due Process and Just Compensation Clauses

by Andrew L. Shane

Harvard Law School

April 30, 2002

supervised by

Peter Barton Hutt

Bear in mind, this is a student paper.

[NeRo9k]

"While I have discussed this in previous commentaries, it is worth repeating here. A major ground upon which the FDA is asserting jurisdiction over electronic cigarettes is that these products are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent." This ground may have been a legitimate one to regulate electronic cigarettes prior to passage of the Tobacco Act, but it no longer holds water given the regulatory framework that was established, quite clearly, by the Tobacco Act and its amendments to FDCA."

"Under the Tobacco Act, electronic cigarettes are also defined as being tobacco products because they are derived from tobacco.

Because electronic cigarettes have as one component nicotine that is derived from tobacco, they constitute a tobacco product under section (rr)(1) of the Tobacco Act."

I've been reading this blog for the last week or two and it's really a great way to follow what's going on and hear about the counter points from someone well informed on the law side of things. http://tobaccoanalysis.blogspot.com/ The last post from today is about smoking in New York, read the posts from earlier in the week.

[ecigg]

@QT I just found out about the letter. I didn't see it listed on the FDA's site the day it was released.

Also another member pointed out that the FDA is only going after 5 electronic cigarettes companies...for now. Do you really think this is it? You have to remember it was only Johnson Creek that had a generic version of Cialis in their E Liquid. It also wasn't "hidden" or just randomly placed into e Liquid. It was actually part of their health line of E Liquid. Which of course has since been removed.

The problem here is the fact that the FDA is going to classify the electronic cigarette as a drug device. That means suppliers may have to start clinical trials in order to continue selling electronic cigarettes. No supplier currently has the cash flow to perform such an operation.

Other members have asked, well why don't all suppliers band together? Well the problem is getting the factories in China to jump on board. It also means we have to continuously monitor the factories in China. Something that could cost thousands of dollars. Right now most suppliers don't have the cash to pony up. If we where selling E Liquid at 20 a pop per 10ml and 150 a pop for starter kits, we might be able to do it. But at discount prices and low volume this just isn't currently an option.

What I'm getting out of this is that most small suppliers will close shop. (The guys that started it all) Vapor Talk included. The electronic cigarette will stay but at the hands of a much larger corporation. It may go under for a short time while clinical studies are done, but will most likely be released at a later date. How it will be released remains a mystery. Will the ecig be an alternative tobacco product? Will it be sold as an over the counter NRT? Will it be prescription based? Time will only tell.

We used to argue that selling it as an alternative rather than an NRT would solve this issue as we'd no longer be making health claims. (Something Vapor Talk has never done anyway) But judging by the letter, the FDA doesn't care how it's being marketed, they want studies done. Period. Is this legal? Do they have the right? Personally I don't think they do, but a lawsuit stretched out over 2 years can bankrupt a small company. It doesn't matter if it's legal or not, small suppliers don't have the money to challenge the fact.

I tell you guys, I have a daughter a wife and health insurance I have to pay out of pocket as I just recently lost my job, and I can tell you right now, because of the FDA we may lose everything. I hope these guys all burn in hell. You try to do good, you try to benefit the economy and you try to pay your taxes which the government desperately needs. In the end uncle sam still screws you. They FDA could easily work with the 3 major ecig companies in China. But wait, that isn't in their interest. Land of the free? More like land of the free to whomever as enough money to buy a lawyer.

I hope things change for the better, but honestly, I don't have much faith.

Hey Chris,

I am sorry to hear about your job loss. I am in the exact same situation as you. 2 months ago I lost my job and I have no health insurance, because I can't afford to pay it. I have a house no wife or kids and student loans and a mortgage to pay.

--If the FDA goes through with this I too will have to belly up and go under. I don't know what I would do either at this point. After reading the letter I am going crazy applying for jobs, but the market sucks right now. The way the government is run I have little to no faith anything will go in our favor.

[NeRo9k]

It's best to stay positive even though it seems destruction is ahead.

[girldragon]

The nicotine in liquid is derived from tobacco, and it's this that grants the FDA governance over e-cigs.

Well, I am not very knowledgable in this area, but the FDA doesn't have control over regular cigarettes do they??

[girldragon]

Great point, Me and a few others were talking about this on video chat the day they sent the letters out, and using regular vaporizers on tobacco you can eliminate the extra chemicals but its not as fun as e cigs, I knew this was coming, stock up time and then ween off lowering your nic level, probably have to order supplies before that court date at the end of this month and thats a few weeks...damn the ECA left alot of people hanging thats bs! oh well just keep rolling with the punches.

When you say regualr vaporizers do you mean humidifiers (like I put in my children's rooms when they are sick?) Also when you say other chemicals what do you mean? PG and VG??

Can you grow tobacco and boil it down and get the nicotine out of it-or do you need alcohol like a tincture to extract it from the plant?? I need to do some research:O)

[ecigg]

Well, I am not very knowledgable in this area, but the FDA doesn't have control over regular cigarettes do they??

Absolutely they do. Plus the FDA loves "Big Tobacco" aka Philip Morris. All the tax money they receive from cigarettes is unreal. The government could care less about our health. There are over 40 Million Americans that still smoke so that's a ton of tax money right in the government's pocket.

[LoriHNC]

The government could care less about our health. There are over 40 Million Americans that still smoke so that's a ton of tax money right in the government's pocket.

Thats just plain sad that the people in charge of making our country a better place for us, is this greedy and uncaring. It's really disheartening.

[ecigg]

Thats just plain sad that the people in charge of making our country a better place for us, is this greedy and uncaring. It's really disheartening.

I completely agree with you. It's extremely sad to see something like this happen. I mean the government says healthcare is costing them billions each year, so I would think they would try their best to promote anything which can lead to a healthier lifestyle. Now I am not saying e-cigs are a "healthier choice", but they certainly would prevent a lot of lung cancer related deaths. And they are certainly a better option then an analog!

[Christopher]

Well, I am not very knowledgable in this area, but the FDA doesn't have control over regular cigarettes do they??

Not originally no. Historically Alcohol Tobacco and Firearms (ATF) used to regulate cigarettes. However Obama passed a law that gave the FDA regulatory power over cigarettes.

[girldragon]

Not originally no. Historically Alcohol Tobacco and Firearms (ATF) used to regulate cigarettes. However Obama passed a law that gave the FDA regulatory power over cigarettes.

Yes-thank you the ATF-holy crap I didn't know that. Lord almighty I can't stand that dumb SOB (hope I don't offend anyone, but i can't stand him)

[Christopher]

To me about it. I think if ATF still had control we might not face some of the issues we are facing now. Hard to say really.

[three_sixteen]

Also another member pointed out that the FDA is only going after 5 electronic cigarettes companies...for now. Do you really think this is it? You have to remember it was only Johnson Creek that had a generic version of Cialis in their E Liquid. It also wasn't "hidden" or just randomly placed into e Liquid. It was actually part of their health line of E Liquid. Which of course has since been removed.

The problem here is the fact that the FDA is going to classify the electronic cigarette as a drug device. That means suppliers may have to start clinical trials in order to continue selling electronic cigarettes. No supplier currently has the cash flow to perform such an operation.

Why was Johnson Creek putting a generic version of Cialis in their liquid? That makes their e-cig a drug delivery device, which is exactly what the FDA is complaining about.

Like I said in another thread, once the FDA starts sending cease and desist letters to people who aren't selling their products as smoking cessation devices or putting pharmaceuticals in their products we can start to safely worry.

[BEERCITYVAPRZ]

When you say regualr vaporizers do you mean humidifiers (like I put in my children's rooms when they are sick?) Also when you say other chemicals what do you mean? PG and VG??

Can you grow tobacco and boil it down and get the nicotine out of it-or do you need alcohol like a tincture to extract it from the plant?? I need to do some research:O)

No I mean personal vaporizers for actual tobacco and herbal blends that can be vaporized thus purifying the smoke making it just nicotine, google the word lolite and you will see what im talking about, good luck.

[BEERCITYVAPRZ]

Yes-thank you the ATF-holy crap I didn't know that. Lord almighty I can't stand that dumb SOB (hope I don't offend anyone, but i can't stand him)

Im sure you didnt offend anyone, I'll admit too, he sucks! This whole banning of e cigs is going to turn a lot of people into libertarians, RON PAUL FOR PRESIDENT IN 2012! now this guy is standing up for something real!

[thephoenix]

the fact that they're doing this with the legal process still in effect is quite troublesome...

either they have no regard for the law or know something we don't...

i can't see how they can classify it as a drug-delivery as the liquid is derived from tobacco. clearly a tobacco product. let's hope the judges are wise & agree...