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Fda Very Bad News


Christopher

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Here are the warning letters sent - our goobermint hard at work.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/default.htm

Face it, right now they are desperate for money. Can't tax, the economy is crud they are desperate.

They are all Unapproved New Drug/Misbranded except for JC who has the distinction of Unapproved New Drug/Misbranded/CGMP for Finished Pharmaceuticals

http://www.ispe.org/cs/resource_library_section/gmp_section/what_is_gmp

Edited by FTJoe
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With all due respect, I would take what I make any day over the stuff from China. What is the lead content of the water in China or Mercury to name a few heavy metals.

I'm not recommending anyone to extract pure nicotine from tobacco. All e-liquid recipes are a home brew at some point when they start. I would not sell it or give out the process without having it tested by a lab and have it consistent. This is why I'm paying lawyers and working on having the testing done and it is not cheap.

Never once has lead been found in E Liquid. In fact the when the FDA tested E Liquid months back even THEY didn't even find lead. So why create a scare where no scare is needed?

Lead tainted products are usually found where paint is found. This is because years ago the United States exported all of their lead issued paint to China. At no point does paint ever come in contact with E Liquid. Not to mention you can pick up lead testing kits from Amazon for under 50 bucks for self assurance. (Although we don't advertise it we test all of our products for lead)

Throwing something out there like that just scares off, would be vapers.

You have to understand that most of this "American Made" E liquid is actually American MIXED. Suppliers purchase un flavored high level nic bottles from China and then mix in flavors into it here in the states. The irony behind it is classic. While not all suppliers do it this way, many do. (PS and JC created their own liquid from scratch)

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Just in. The FDA is starting to send cease and desist letters to suppliers informing them they are breaking federal law. This is an important article that needs to be read. This is what we've all been expecting. This is NOT good news.

http://online.wsj.com/article/BT-CO-20100909-711729.html

Also

From the Food and Drug Administrations website:

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm

I find it amazing that the FDA can approve loads of drugs that have been recalled, medical devices that are clearly dangerous & not recall medications they clearly should, yet when it comes to anything to do with natural medications (which used with knowledge of those products is FAR safer). the FDA seems to want to ban everything natural... Remember the vitamin raids in the late '80's? The tryptophan ban around 1988 b/c one single shipment from China was contaminated - no others were found to be contaminated, yet ALL of them were banned for a long time! The Ma Huang ban, which still exist, yet for those given corticosteroids with a bad reaction, this may be the only thing that can stop someone from developing life-long high BP, diabetes (insulin resistant), brain swelling, catabolism and many more devastating effects, yet they allow doctors to hand out these damaging injections & pills like they are candy, costing everyone - especially the victim of these drugs who can develop life-long disabilities, tons of money & heart ache.

If you google Medtronic lawsuit (re: their fault medical devices), you'll see tons of lawsuits filed, yet because those are "FDA approved medical devices", not one person who has had broken leads, been paralyzed, or in cases of death, their families cannot recover a single thing from the manufacturers because of a law passed by the Bush administration that exempts ANY "FDA-approved medical device" from recovery of ANY damages, and it's clear, these devices tanked in quality ever since that law was enacted.

The FDA needs to stop violating people's rights, they need to hold those medical device companies to standards & STOP infringing on people's rights to buy products that are natural (& some "not-so-natural"), including e-cigs, herbal liquids & other similar devices. This is like banning herbal remedies from the market, which have been proven time & time again to be safer than allopathic medicines prescribed or OTC for the same purposes!

The judge that stopped the FDA's seizure of e-cig products was right - the FDA over-stepped their boundaries!

So, I take a vitamin C... are they going to ban vitamins again or is my hand that puts it in my mouth going to be an FDA banned "drug delivery device" too?

I suppose we should just stop driving cars too, as they emit harmful hydrocarbons? Buses? HE** diesel fuel is even worse and we ALL have to breath those things! We have no escape & no choice!

Humidifiers? Guess those would have to go too... Breathing? Wait! If we breathe, we are taking in all sorts of harmful substances from smog, trees, etc.

Drinking water? I just read a study on chloramines & our water, regulated by the EPA, at the tap in municipal water systems is full of truly dangerous chloramines... Even wastewater engineers are concerned about it & eat shrimp? Not with the concentrations of Prozac in them from wastewater! THey can't get that stuff out of the water & the shrimp are full of it, and God only knows what else!

So, according to the FDA, it's not safe to breathe, drink or use municipal water (packing plants use this water too & there are even lawsuits going on about chloramines and their carcinogenic byproducts, including lead and copper it erodes from the pipes) contaminating food, even baby food), and not even safe to take a bath or shower, or eat seafood. Our beef & vegetables have also been contaminated and have made many people ill &s many have died, but that's OK by the FDA?

No one yet has proven to me a Big Mac is totally safe! (isn't that what that kid in Oregon ate & died?) And the lettuce & onion fiascos? The onions were destroyed by the grower, only tofind one of Taco Bell's supplier's warehouses was the source of contamination!

I have YET to hear of a single person becoming ill from use of an eCigarette, and with 20-30,000 people a DAY switching from smoking, or using 0 nic for those who just enjoy it & would rather not take up smoking or e-cigs with nicotine, the FDA should be thankful someone invented e-cigs!

Walmart & other stores carried pet food that was killing animals! Did they go after Walmart? Nope! They worked with the industry to find the source, which was a plant in Canada, did recalls like any sane response would be, had stores pull the deadly products and it was over!

Ecigs need to be treated like food! If a trend develops of people getting sick from a certain batch from a specific supplier, go to THAT supplier & recall the products, not the entire industry!

Would the FDA rather have us smoke cigarettes? Clearly not, or they wouldn't have spent the $Billions on making everyone paranoid about cigarettes & raised the taxes so darn high. They should have looked at the addition of carcinogenic chemicals to the cigarettes, not the tobacco itself! If ANYONE has EVER read a study on smoking that excluded cigarettes with chemical additives, PLEASE PM ME! I have yet to see a single one!

We eat foods every day that are mislabeled or are not labelled at all, so where is the FDA in those cases?

This FDA witch hunt of eCigs is just like the vitamin & supplement bans of the 1980's, which clearly stomp all over civil rights & my religious beliefs, as well as my health.

I've yet to see the FDA go after manufacturing companies who clearly pollute our air with toxins, the drug companies whose drugs were recently found in shrimp - yes! Prozac in shrimp! A full dose if you eat it for your evening portion of protein! I can only guess what higher food chain species are full of! Mercury certainly! Why haven't they gone after that source? That's been a serious problem affecting health for far more than 20 years!

It seems like the FDA's idea is we shouldn't have anything natural or naturally derived in our eCigs or in our food!

This is CLEARLY a civil rights issue, freedom of religion, and freedom of life & liberty... I guess those fighting cigarettes/tobacco & eCigs have never read the constitution!

The anti-supplement/anti-tobacco/ anti-eCig hysteria is foolish at best. I suppose htey'd have us all eating chemically-created food as well. Sounds like Soylent green isn't too far off.

A few quotes from Soylent Green, the 1973 Sci-Fi movie from imbd.com:

Det. Thorn: I know, Sol, you've told me a hundred times before. People were better, the world was better...

Sol: Ah, people were always lousy... But there was a world, once.

[Thorn chuckles]

Sol: I was there, I can prove it! When I was a kid, you could buy meat anywhere! Eggs they had, real butter! Not this... crap!

...

Sol: Why, in my day, you could buy meat anywhere! Eggs they had, real butter! Fresh lettuce in the stores.

Det. Thorn: I know, Sol, you told me before.

...

Det. Thorn: Would you believe bodyguards are buying strawberries for 150 D's a jar?

Yes, the FDA IS just that ridiculous! This is a slippery slope they are on!

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The root of the problem is finding a way to regulate and tax it.The Gov. needs to have it limited to a few manufacturers and suppliers so it can be tracked and taxed much the way they do liquor and tobacco.As it is now there is no way to keep track of how much is coming and going or being spent on it.I am pretty confident vaping is here to stay just not as it is now.

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I find it amazing that the FDA can approve loads of drugs that have been recalled, medical devices that are clearly dangerous & not recall medications they clearly should, yet when it comes to anything to do with natural medications (which used with knowledge of those products is FAR safer). the FDA seems to want to ban everything natural... Remember the vitamin raids in the late '80's? The tryptophan ban around 1988 b/c one single shipment from China was contaminated - no others were found to be contaminated, yet ALL of them were banned for a long time! The Ma Huang ban, which still exist, yet for those given corticosteroids with a bad reaction, this may be the only thing that can stop someone from developing life-long high BP, diabetes (insulin resistant), brain swelling, catabolism and many more devastating effects, yet they allow doctors to hand out these damaging injections & pills like they are candy, costing everyone - especially the victim of these drugs who can develop life-long disabilities, tons of money & heart ache.

If you google Medtronic lawsuit (re: their fault medical devices), you'll see tons of lawsuits filed, yet because those are "FDA approved medical devices", not one person who has had broken leads, been paralyzed, or in cases of death, their families cannot recover a single thing from the manufacturers because of a law passed by the Bush administration that exempts ANY "FDA-approved medical device" from recovery of ANY damages, and it's clear, these devices tanked in quality ever since that law was enacted.

The FDA needs to stop violating people's rights, they need to hold those medical device companies to standards & STOP infringing on people's rights to buy products that are natural (& some "not-so-natural"), including e-cigs, herbal liquids & other similar devices. This is like banning herbal remedies from the market, which have been proven time & time again to be safer than allopathic medicines prescribed or OTC for the same purposes!

The judge that stopped the FDA's seizure of e-cig products was right - the FDA over-stepped their boundaries!

So, I take a vitamin C... are they going to ban vitamins again or is my hand that puts it in my mouth going to be an FDA banned "drug delivery device" too?

I suppose we should just stop driving cars too, as they emit harmful hydrocarbons? Buses? HE** diesel fuel is even worse and we ALL have to breath those things! We have no escape & no choice!

Humidifiers? Guess those would have to go too... Breathing? Wait! If we breathe, we are taking in all sorts of harmful substances from smog, trees, etc.

Drinking water? I just read a study on chloramines & our water, regulated by the EPA, at the tap in municipal water systems is full of truly dangerous chloramines... Even wastewater engineers are concerned about it & eat shrimp? Not with the concentrations of Prozac in them from wastewater! THey can't get that stuff out of the water & the shrimp are full of it, and God only knows what else!

So, according to the FDA, it's not safe to breathe, drink or use municipal water (packing plants use this water too & there are even lawsuits going on about chloramines and their carcinogenic byproducts, including lead and copper it erodes from the pipes) contaminating food, even baby food), and not even safe to take a bath or shower, or eat seafood. Our beef & vegetables have also been contaminated and have made many people ill &s many have died, but that's OK by the FDA?

No one yet has proven to me a Big Mac is totally safe! (isn't that what that kid in Oregon ate & died?) And the lettuce & onion fiascos? The onions were destroyed by the grower, only tofind one of Taco Bell's supplier's warehouses was the source of contamination!

I have YET to hear of a single person becoming ill from use of an eCigarette, and with 20-30,000 people a DAY switching from smoking, or using 0 nic for those who just enjoy it & would rather not take up smoking or e-cigs with nicotine, the FDA should be thankful someone invented e-cigs!

Walmart & other stores carried pet food that was killing animals! Did they go after Walmart? Nope! They worked with the industry to find the source, which was a plant in Canada, did recalls like any sane response would be, had stores pull the deadly products and it was over!

Ecigs need to be treated like food! If a trend develops of people getting sick from a certain batch from a specific supplier, go to THAT supplier & recall the products, not the entire industry!

Would the FDA rather have us smoke cigarettes? Clearly not, or they wouldn't have spent the $Billions on making everyone paranoid about cigarettes & raised the taxes so darn high. They should have looked at the addition of carcinogenic chemicals to the cigarettes, not the tobacco itself! If ANYONE has EVER read a study on smoking that excluded cigarettes with chemical additives, PLEASE PM ME! I have yet to see a single one!

We eat foods every day that are mislabeled or are not labelled at all, so where is the FDA in those cases?

This FDA witch hunt of eCigs is just like the vitamin & supplement bans of the 1980's, which clearly stomp all over civil rights & my religious beliefs, as well as my health.

I've yet to see the FDA go after manufacturing companies who clearly pollute our air with toxins, the drug companies whose drugs were recently found in shrimp - yes! Prozac in shrimp! A full dose if you eat it for your evening portion of protein! I can only guess what higher food chain species are full of! Mercury certainly! Why haven't they gone after that source? That's been a serious problem affecting health for far more than 20 years!

It seems like the FDA's idea is we shouldn't have anything natural or naturally derived in our eCigs or in our food!

This is CLEARLY a civil rights issue, freedom of religion, and freedom of life & liberty... I guess those fighting cigarettes/tobacco & eCigs have never read the constitution!

The anti-supplement/anti-tobacco/ anti-eCig hysteria is foolish at best. I suppose htey'd have us all eating chemically-created food as well. Sounds like Soylent green isn't too far off.

A few quotes from Soylent Green, the 1973 Sci-Fi movie from imbd.com:

Det. Thorn: I know, Sol, you've told me a hundred times before. People were better, the world was better...

Sol: Ah, people were always lousy... But there was a world, once.

[Thorn chuckles]

Sol: I was there, I can prove it! When I was a kid, you could buy meat anywhere! Eggs they had, real butter! Not this... crap!

...

Sol: Why, in my day, you could buy meat anywhere! Eggs they had, real butter! Fresh lettuce in the stores.

Det. Thorn: I know, Sol, you told me before.

...

Det. Thorn: Would you believe bodyguards are buying strawberries for 150 D's a jar?

Yes, the FDA IS just that ridiculous! This is a slippery slope they are on!

Very well said. This should be sent to state and federal representatives. There are links in this thread to write them.

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Never once has lead been found in E Liquid. In fact the when the FDA tested E Liquid months back even THEY didn't even find lead. So why create a scare where no scare is needed?

Lead tainted products are usually found where paint is found. This is because years ago the United States exported all of their lead issued paint to China. At no point does paint ever come in contact with E Liquid. Not to mention you can pick up lead testing kits from Amazon for under 50 bucks for self assurance. (Although we don't advertise it we test all of our products for lead)

Throwing something out there like that just scares off, would be vapers.

You have to understand that most of this "American Made" E liquid is actually American MIXED. Suppliers purchase un flavored high level nic bottles from China and then mix in flavors into it here in the states. The irony behind it is classic. While not all suppliers do it this way, many do. (PS and JC created their own liquid from scratch)

I didn't say this to scare off would be vapor users and I apologize if that is how I came off. E-cigs have (in my opinion) saved my life. I agree that testing is needed for anything we put into our bodies. My point is you don't know for sure unless it is tested.

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Sorry didn't mean to come off hard :) I agree E Liquid does need to be tested. The problem is when it comes down to individual supplier testing. (Some tests can run upwards of 70k a batch) It would be nice to see the FDA work with the major E Liquid factories in China. This could solve the problem right off the bat. I've spoken to representatives from the factories in China who would be willing to work with the FDA if they'd be willing to work with them. However I don't see that happening any time soon.

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Sorry didn't mean to come off hard :) I agree E Liquid does need to be tested. The problem is when it comes down to individual supplier testing. (Some tests can run upwards of 70k a batch) It would be nice to see the FDA work with the major E Liquid factories in China. This could solve the problem right off the bat. I've spoken to representatives from the factories in China who would be willing to work with the FDA if they'd be willing to work with them. However I don't see that happening any time soon.

No worries Chris we all are passionate about about this subject. :D

Yes it would be nice if the FDA would work with Chinese suppliers it would help put to rest a lot of worries and help make vaping as safe as it can be. It would weed out those that are just out for the profit.

In addition I would like to see the FDA start doing case studies on the use of an e-cig to study long term effects good or bad. I would sign up in a heart beat.

This is the company I was looking into to do testing my liquid http://www.alliancetechgroup.com/index.html and it is not for the average Jo's pocket book.

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I'm all for regulating the product, ensuring it's quality, but I have to agree with others who protest the "ban" of certain places instead of pulling their juice from the shelves. Pull their juice, make them adhere to strict guidelines, go get em tiger! But to ban them? Totally insane.

I thought Supplements were kind of neutral territory. Isn't that why they're so lax with all the false claims by the diet and energy world? If so, would it be plausible to consider ejuice a supplement (even though it really does work and we're not supposed to claim that claim)... what a twisted world. grrrr

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Unfortunately, I do not have a Wall Street Journal subscription and therefore don't have access to the article beyond the first couple of sentences. Would someone please be so kind as to copy the article in its entirety and email it to me? Please contact me directly for my email. Thank you so much! We have been expecting this....

Just in. The FDA is starting to send cease and desist letters to suppliers informing them they are breaking federal law. This is an important article that needs to be read. This is what we've all been expecting. This is NOT good news.

http://online.wsj.co...909-711729.html

Also

From the Food and Drug Administrations website:

http://www.fda.gov/N...s/ucm172906.htm

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I'm all for regulating the product, ensuring it's quality, but I have to agree with others who protest the "ban" of certain places instead of pulling their juice from the shelves. Pull their juice, make them adhere to strict guidelines, go get em tiger! But to ban them? Totally insane.

I thought Supplements were kind of neutral territory. Isn't that why they're so lax with all the false claims by the diet and energy world? If so, would it be plausible to consider ejuice a supplement (even though it really does work and we're not supposed to claim that claim)... what a twisted world. grrrr

That's funny you mention supplements. I was just going over this with my partner and supplements are not FDA approved. Look at all the crap in those things!! Those energy/fat loss products have extremely high amounts off herbal crap and caffeine and tons of stuff that nobody has a clue about.

You can still buy ephedrine for crying out loud! ephedrine has caused heart attacks and one a pitcher from the Orioles died!

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That's funny you mention supplements. I was just going over this with my partner and supplements are not FDA approved. Look at all the crap in those things!! Those energy/fat loss products have extremely high amounts off herbal crap and caffeine and tons of stuff that nobody has a clue about.

You can still buy ephedrine for crying out loud! ephedrine has caused heart attacks and one a pitcher from the Orioles died!

Scarey isn't it.

But, it might be a route to take... and then the industry can regulate it's own. Licensing, testing, test kits that vapors can buy so they can test all bottles that arrive, ... I don't know. But there must be a way to self govern, self regulate, and be safe for all involved.

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I have a question. It seems to me that getting all the components for a good e-juice -- except NICOTINE -- is easy and cheap sourcing here in the US. What would be so bad about selling juice without the nic? It tastes great, you can make it with a fine throat hit and vapor, so why the question about Chinese-sourced ingredients? I think that is an issue we can get around. As for the rest of it: the drug-delivery issue of the hardware, etc.; -- this juice issue should be straight forward. Unless it's not. Let us not focus on the things we cannot control and that are problematic. Perhaps there's a middle way. Nicotine is not, I think, the categorical imperative. We need to focus on the sustenance if our businesses. We are NOT in the nicotine delivery business. Some may disagree. I would like to hear your thoughts.

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http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm

^^^ THATS THE LINK TO SEND THE FDA A COMMENT ABOUT HOW E-CIGS ARE HELPING NOT HURTING!!!^^^

Thanks for the link I just sent my comment

Comment:

I just want to express my experience with the E-Cig. I'm 48 and had been smoking cigarettes since I was 12 years old. I had been trying to quit for the last 10 years without success.I tried the patches, gum,Ziban and still smoked 2 packs a day. It took 1 week on an e-cigarette to kick smoking for good. I have been using my e-cig now for 1 year and have my taste back. I have this summer started riding a bike and climb stairs without a second thought. I no longer cough every 5 minutes. I no longer have chest pain. My family is no longer in danger of second hand smoke. Please don't kill me and my family by taking my only working option away.

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Scarey isn't it.

But, it might be a route to take... and then the industry can regulate it's own. Licensing, testing, test kits that vapors can buy so they can test all bottles that arrive, ... I don't know. But there must be a way to self govern, self regulate, and be safe for all involved.

Very scary, indeed! It certainly would be a route to take, but the way the government is going I don't see them allowing anyone to self govern anything. It is one thing after another with the government today. If vaping helps people quit smoking why not allow it! We have such a problem with this country in regards to healthcare. Anything to help that I think is a step in the right direction. Smokers usually love to smoke and the e-cig gave them that ability without the 2000 + chemicals.

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I don't want regulation. I've said it before, and I'll say it again; do we want our liquid regulated by the people who approve cigarettes? The FDA has no problem with them, and they... you know... KILL PEOPLE. If they get their hands on it, our liquid will contain chemicals that serve no purpose other than to kill us slowly. If we're going to inhale something full of deadly chemicals, why not go down to the gas station and buy a pack of cigarettes? Much easier to maintain than an electronic one, with the same delicious and deadly additives.

If they want to regulate it and keep it clean, AWESOME! :thumbsup:

But, who here HONESTLY thinks that they would?

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Very scary, indeed! It certainly would be a route to take, but the way the government is going I don't see them allowing anyone to self govern anything. It is one thing after another with the government today. If vaping helps people quit smoking why not allow it! We have such a problem with this country in regards to healthcare. Anything to help that I think is a step in the right direction. Smokers usually love to smoke and the e-cig gave them that ability without the 2000 + chemicals.

Sad and true about the gov. But it was a fun brainstorm while it lasted. :)

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I don't want regulation. I've said it before, and I'll say it again; do we want our liquid regulated by the people who approve cigarettes? The FDA has no problem with them, and they... you know... KILL PEOPLE. If they get their hands on it, our liquid will contain chemicals that serve no purpose other than to kill us slowly. If we're going to inhale something full of deadly chemicals, why not go down to the gas station and buy a pack of cigarettes? Much easier to maintain than an electronic one, with the same delicious and deadly additives.

If they want to regulate it and keep it clean, AWESOME! :thumbsup:

But, who here HONESTLY thinks that they would?

Excellent points as well.

But they're OUR invention.. the guy, Hun, invented them for us, the smoker, so that we would not die a horrible death like his father did. PM is the anti-us, they have no rights to our wrights right?

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I just wrote out a long lengthy e-mail to one of my representatives here in Maryland, Senator Barbara Mikulski. It was probably too long and winded but it was a start. And wouldn't you know it? As soon as I had finished and hit the send button up pops a page that the website is having trouble and my whole e-mail disappears and I'm directed to another page with nothing about sending e-mails to reps.

This whole thing has me in such a fit that I'd like to get a hold of those a-holes at the FDA and well I won't say it.

Drug delivery device...unsafe ingredients...unknown long term health risks. Just a lot of crap for the FDA to use to get their way and cash in on the money. They are not a federal agency, and shouldn't be allowed to regulate a pack of gum much less something they have know idea what they are talking about. What there job should be is to test and evaluate and then contact those involved as to their findings. Then work with said companies to make the products safe. They should not be given the powers of omnipotence to choose who shall live and who shall die. And by forcing us to go back to analogs that's exactly what they are doing. We all have our own stories about e-cigs and our thoughts about how they haven't killed or injured any body that we know of. No one has burned down their house or killed their family from falling asleep with one. No one has committed suicide from vaping. You never hear of someone taking a 2000lb auto and running down a person or killing someone. Yet every day in the news you hear about such things being done by people using "approved" drugs and alcohol. I'm not for the FDA regulating my life and the government is already doing more than enough to me with their laws. I read a quote somewhere that said "The government that governs least, governs best" It's about time ours started listening.

DAmn I'm pissed....sorry

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No worries Chris we all are passionate about about this subject. :D

Yes it would be nice if the FDA would work with Chinese suppliers it would help put to rest a lot of worries and help make vaping as safe as it can be. It would weed out those that are just out for the profit.

In addition I would like to see the FDA start doing case studies on the use of an e-cig to study long term effects good or bad. I would sign up in a heart beat.

This is the company I was looking into to do testing my liquid http://www.alliancetechgroup.com/index.html and it is not for the average Jo's pocket book.

Interesting. Thanks for the link. Any ball park quotes?

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