Fda Classifying Ecig As Drug Product

[Christopher]

If you have not already read this letter, take a look. It was sent to the ECA the day the FDA started sending out cease and desist letters. (The ECA is no longer operational last we heard due to financial reasons, I have a feeling the FDA is unaware)

http://www.fda.gov/downloads/Drugs/GuidanceCompianceRegulatoryInformation/UCM225263.pdf

Looks like they are classifying the electronic cigarette a drug delivery device even before the lawsuit is over. Hold on to your seats suppliers.

[JayH503]

So this means that suppliers can't sell E Cigs or anything relating to them, and we can't purchase E Cigs or anything related to them? Right?

[Brian]

Pretty clear about their intentions in this one.

[Christopher]

So this means that suppliers can't sell E Cigs or anything relating to them, and we can't purchase E Cigs or anything related to them? Right?

It doesn't mean you can't purchase electronic cigarettes, it means suppliers will have to start clinical trials in order to sell their product. Something many of us, don't have the money for. So inadvertently yes, there is a chance that suppliers will go under.

Some people have argued that the FDA has no right to do this as ecigs should not fall under the drug & cosmetic act. But let's be honest, most suppliers do not have the capital to jump in on a lawsuit. I'm quite surprised they are doing this before the current lawsuit is over. As Brain said, they are very clear in what their intentions are.

[nana]

[Mark]

If you have not already read this letter, take a look. It was sent to the ECA the day the FDA started sending out cease and desist letters. (The ECA is no longer operational last we heard due to financial reasons, I have a feeling the FDA is unaware)

http://www.fda.gov/downloads/Drugs/GuidanceCompianceRegulatoryInformation/UCM225263.pdf

Looks like they are classifying the electronic cigarette a drug delivery device even before the lawsuit is over. Hold on to your seats suppliers.

Could be a WILD ride.........

[StOmPeR]

The FDA is a unconstitutional Agency of the Federal Government - no where in the constitution does it give authority for such a agency to exist! The duty's assigned to the FDA should, and ought to be, given to the states! That alone would save the federal government billions a year!

[JayH503]

Christopher, At this rate, how long are we going to be able to purchase E Cigs and supplies before this goes into law? Sounds like everything's being passed and approved right through the system without any kind of legal protocol! You said the lawsuit isn't even decided on yet!

[Uma]

That's that letter I worried for in the other FDA thread... the ECA not being together anymore, yet they recieve a letter from the FDA instead of the active major groups out there like CASAA(?).

I can't read it, my laptop shows only black page without words.

What will Judge Leon think of this I wonder.

[girldragon]

Now, wait a minute-is the nicotine in the liquid extracted from tobaco plants or synthesized in a lab? If it is a natural extract than the laws that govern tobaco would be the laws that govern e-cigs. Anyone know? This may be a way around the "drug" vs. a natural extract-which btw as a maker of personal body products using all natural ingredients-they are desperately trying to control "natural" ingredients as well-but right now, they only have the right to dictate labeling. If it is extracted from a natural plant-then it is merely "liquid tobaco" and that is a gray area in which at this time they do not control.

Gel caps are not considered a drug delivery system for St. John's wart or Acai or any of the other "natrual" healing (or not) extracts. If you can extract the nicotine from the plant-it is an extract and not any more of a drug than a cigarette in which the Alcohol, Tobaco guys would be in charge (not necessarily better)

[Jkimbo]

A long time critic of the FDA, Ron Paul continues to fight against this evil unconstitutional div of organized crime.

http://www.lewrockwell.com/sardi/sardi72.html

He said it best here...

The FDA, like all federal agencies, ultimately uses its regulatory powers in political ways. Certain industries and companies are rewarded, and others are punished. No regulatory agency is immune from politics, which is why the FDA should not be trusted with power over our intimate health care decisions

Fock the FDA, their days are numbered too

Edited September 16, 2010 by Jkimbo

[Lily]

Very interesting letter. Clearly the FDA legal team is laying the groundwork for stiff regulation, but my sense is they're also thumbing their noses at the e-cigarette industry imo. I'm wondering though, could this (letter) backfire and/or could it be grounds for an appeal in the upcoming case? I would definitely have to do some research on this, but would soliciting the E-Cigarette Association be of any value now or down the road? The FDA appears deaf, but bringing this to ECA's attention and other interested parties, would that give us more of a voice?

The letter made me wonder as I was reading through it, how extensive was and is the FDA's testing of the known carcinogens (and yes, pharmaceuticals) in analog cigarettes as far as in "a manner consistent with protecting the public health". It's hypocritical beyond any words.

[Popsicle]

Very interesting letter. Clearly the FDA legal team is laying the groundwork for stiff regulation, but my sense is they're also thumbing their noses at the e-cigarette industry imo. I'm wondering though, could this (letter) backfire and/or could it be grounds for an appeal in the upcoming case? I would definitely have to do some research on this, but would soliciting the E-Cigarette Association be of any value now or down the road? The FDA appears deaf, but bringing this to ECA's attention and other interested parties, would that give us more of a voice?

The letter made me wonder as I was reading through it, how extensive was and is the FDA's testing of the known carcinogens (and yes, pharmaceuticals) in analog cigarettes as far as in "a manner consistent with protecting the public health". It's hypocritical beyond any words.

That's what I keep thinking. The FDA doesn't understand how bad they're going to look if they ban electronic cigarettes. They have been committing crimes against our health for a while now, but this one is going to be too obvious. They're trying to keep cigarettes, but ban electronic cigarettes. If they actually follow through, everyone will finally realize the scam that they are operating. It is going to be bad news for us, but REALLY bad news for the FDA.

[bobthesalesclerk]

Couldn't all the different suppliers pull there money together, get all the needed testing done, and split profits??? I mean you would take a profit hit but if you pull your money together there must be something you can do.

Maybe even start taking donations from customers or raise prices on everything by a buck or two and put all that money into product testing.

Edited September 16, 2010 by bobthesalesclerk

[AbbyNormal]

Couldn't all the different suppliers pull there money together, get all the needed testing done, and split profits??? I mean you would take a profit hit but if you pull your money together there must be something you can do.

Maybe even start taking donations from customers or raise prices on everything by a buck or two and put all that money into product testing.

I agree. If it's the price of testing that's a concern for suppliers, I think as consumers we should pitch in. If we want to keep getting the products we have to do what we can to keep suppliers in business. I can't speak for everyone but I'd take a price increase over nothing. I've just starting using e-cigs this past week and the second I starting vaping I quit smoking analogs. I know if I have access to e-cigs I'll never go back to smoking analogs. I'm also sure if I no longer had access to my e-cig I'd go right back to smoking analogs and destroying my health. It's really ridiculous to me how an organization that's meant to "protect" us is basically damning us. It's all bull**** and politics and it makes me sick.

[three_sixteen]

Listen, I really hate to sound like I'm defending the FDA here - but I didn't see anything in that letter that indicated they were going to treat ALL electronic cigarettes as drug devices. I'm not convinced yet that we need to start freaking out.

Its painfully obvious that they're referring to the five companies they sent letters to with particular focus on the marketers who are putting weight loss and erectile dysfunction drugs into the liquid they sell.

FDA has determined that the electronic cigarette

products addressed in the warning letters described above, and similar products, meet the

definitions of both a drug and device under the Act and the definition of a combination product

in 21 C.F.R. Part 3, with a drug primary mode of action.

[three_sixteen]

Now, wait a minute-is the nicotine in the liquid extracted from tobaco plants or synthesized in a lab? If it is a natural extract than the laws that govern tobaco would be the laws that govern e-cigs. Anyone know?

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

[owutaqt]

If you have not already read this letter, take a look. It was sent to the ECA the day the FDA started sending out cease and desist letters. (The ECA is no longer operational last we heard due to financial reasons, I have a feeling the FDA is unaware)

http://www.fda.gov/downloads/Drugs/GuidanceCompianceRegulatoryInformation/UCM225263.pdf

Looks like they are classifying the electronic cigarette a drug delivery device even before the lawsuit is over. Hold on to your seats suppliers.

Is this a new letter? If it was sent the 8th why is it just now coming about? I don't get it.

[QuiksilverPR]

This whole situation sucks !!!!

[Schizophretard]

Listen, I really hate to sound like I'm defending the FDA here - but I didn't see anything in that letter that indicated they were going to treat ALL electronic cigarettes as drug devices. I'm not convinced yet that we need to start freaking out.

Its painfully obvious that they're referring to the five companies they sent letters to with particular focus on the marketers who are putting weight loss and erectile dysfunction drugs into the liquid they sell.

But all electronic cigarettes become guilty until proven innocent because of guilt by association. If the FDA just says,"electronic cigarettes." it freaks me out because to the FDA those are dirty words.

[Christopher]

@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.

[owutaqt]

@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.

I know it does not much matter if they are going after 5 or 500 they are trying to gain ground and that sucks.

I am sorry for the suppliers and you especially because it hits home so hard. I think that the best we can do is keep on hoping for the best and expecting the worse.

I know a lot of ppl are worried about how they are going to keep vaping and I know you are worried how you are going to keep food on the table, I'm sorry.

I hope this whole thing settles down a bit after the hearing next week.

[BEERCITYVAPRZ]

Now, wait a minute-is the nicotine in the liquid extracted from tobaco plants or synthesized in a lab? If it is a natural extract than the laws that govern tobaco would be the laws that govern e-cigs. Anyone know? This may be a way around the "drug" vs. a natural extract-which btw as a maker of personal body products using all natural ingredients-they are desperately trying to control "natural" ingredients as well-but right now, they only have the right to dictate labeling. If it is extracted from a natural plant-then it is merely "liquid tobaco" and that is a gray area in which at this time they do not control.

Gel caps are not considered a drug delivery system for St. John's wart or Acai or any of the other "natrual" healing (or not) extracts. If you can extract the nicotine from the plant-it is an extract and not any more of a drug than a cigarette in which the Alcohol, Tobaco guys would be in charge (not necessarily better)

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.

[owutaqt]

One week from today is the hearing! One week!

[BEERCITYVAPRZ]

@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.

I feel your pain bro, hope it gets better and try to just do what you gotta do to make things work.