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Fda Very Bad News


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#61 OFFLINE   Compenstine

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Posted 09 September 2010 - 03:20 PM

View Postgirldragon, on 09 September 2010 - 03:15 PM, said:

Do you get nicotine liquid in your home town? If so where-I am not giving up getting my fix lol! it's going to skyrocket in price after regulation and I want to stock up!

Yes it will go up in price that is true, and yes, I can make Nic liquid with bulk tobaccos. ;)

#62 OFFLINE   LoriHNC

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Posted 09 September 2010 - 03:24 PM

View PostCompenstine, on 09 September 2010 - 03:20 PM, said:

Yes it will go up in price that is true, and yes, I can make Nic liquid with bulk tobaccos. ;)

Wow, I'd be interested in knowing how that is done. Very cool.

#63 OFFLINE   FTJoe

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Posted 09 September 2010 - 03:31 PM

View PostCompenstine, on 09 September 2010 - 02:53 PM, said:

I think we all saw some regulation coming down the pipe.I think the statement above shows they (the FDA) are not trying to outlaw them permanently. Yes it is not news that is all good but, I think it shows that E-Cigs have a future. It shows the FDA is trying to set standards for safety. I for one have been making my own fluids now from products that I can get in my home town. I think the statement above is a call for those that want to supply the E cig market with high quality products to do so in time legally with FDA approval. I can assure you that even Nicotine patches and gum needed to be cleared through FDA regulations.
I believe they are going to kill this with a two prong approach.  Fluids fall under the food jurisdiction, they said to have found two suppliers that are tainting the juice.  That's the Food part of the agency.  Fine.  But now if you want to add a substance called nicotine, that falls under the D part of FDA.  They will claim, rightfully so, that absorption rates are unknown, the other chemicals being brought in with the nicotine are unknown, side effects are unknown, etc.  And they will be right, this is actually their job.  It sucks and I'm 0 nic so I can actually make out.  But how long do you think the hardware will be around if the juice goes away?  I have to go clean out one tainter of juice, Johnson Creek before they get shut down.  Maybe its all lies, but I saw vids off their site of clean rooms etc. that made me proud of them.  You know half the stuf you get is bathtub gin (not VT of course, I'm talking the mixers out there).

BTW - schizo had plans to buy something to extract nicotine, maybe he will chime in.  If not I will PM him.

#64 OFFLINE   Christopher

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Posted 09 September 2010 - 03:35 PM

The last thing we need is home brewed nicotine. I'd take liquid from China any day over someone mixing it in their kitchen. This is exactly why the FDA wants regulation. The ecig industry is all over the place.

#65 OFFLINE   LoriHNC

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Posted 09 September 2010 - 03:43 PM

View PostChristopher, on 09 September 2010 - 03:35 PM, said:

The last thing we need is home brewed nicotine. I'd take liquid from China any day over someone mixing it in their kitchen. This is exactly why the FDA wants regulation. The ecig industry is all over the place.

So you think we could possibly still get nic liquid and parts from out of the country if theres a US ban? Isn't customs stopping it from coming in?

#66 OFFLINE   Compenstine

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Posted 09 September 2010 - 03:50 PM

View PostLoriHNC, on 09 September 2010 - 03:24 PM, said:

Wow, I'd be interested in knowing how that is done. Very cool.

It is not really hard to do and stumbled on it quite by accident. That is all I want to say because, I have been working on selling it, the lawyers I have been working with are not cheap. Now it looks like I will have to jump through more hoops. :(

#67 OFFLINE   Compenstine

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Posted 09 September 2010 - 04:05 PM

View PostChristopher, on 09 September 2010 - 03:35 PM, said:

The last thing we need is home brewed nicotine. I'd take liquid from China any day over someone mixing it in their kitchen. This is exactly why the FDA wants regulation. The ecig industry is all over the place.

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.

Edited by Compenstine, 09 September 2010 - 04:53 PM.


#68 OFFLINE   Brian

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Posted 09 September 2010 - 04:08 PM

View PostLoriHNC, on 09 September 2010 - 03:43 PM, said:

So you think we could possibly still get nic liquid and parts from out of the country if theres a US ban? Isn't customs stopping it from coming in?
I think China will continue to ship anything we want to buy, but yes, some will get seized.  But how much time is going to be spent looking for packages sent to individuals?  My guess is with the volume of shipments coming in, they won't get many, but I could totally be wrong.

Not the news I wanted to hear today.

#69 OFFLINE   ecigg

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Posted 09 September 2010 - 04:25 PM

While this is a concern, I hope that we will be okay.  I can't believe that some of these companies put that crap in their e-juice.   I am about to write an email to ecig.com and say what the heck were u thinking!!

#70 OFFLINE   ThaHodgehound

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Posted 09 September 2010 - 04:25 PM

View PostBrian, on 09 September 2010 - 04:08 PM, said:

I think China will continue to ship anything we want to buy, but yes, some will get seized.  But how much time is going to be spent looking for packages sent to individuals?  My guess is with the volume of shipments coming in, they won't get many, but I could totally be wrong.

Not the news I wanted to hear today.

I agree with Brian on this......hit and miss AT BEST with individual, small orders.

#71 OFFLINE   ecigg

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Posted 09 September 2010 - 04:28 PM

View PostThaHodgehound, on 09 September 2010 - 04:25 PM, said:

I agree with Brian on this......hit and miss AT BEST with individual, small orders.

The people at some of these companies are from China themselves.  IE e-cig.com.  Yes their "office" is in Las Vegas, but they are technically based out of China.  It's companies like them they are ruining this for the rest of the good suppliers.

#72 OFFLINE   FTJoe

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Posted 09 September 2010 - 04:33 PM

I completely agree.  In a perfect world, I would want regulation.  In this world I have no idea how we get it without giving something up.  But they will force many into doing "odd" things in order to do what they KNOW is healthier for them, vape.  

FYI - got my JC order in, I noticed this on their site, as I suspected, because they are an American company making juice, they kind of put themselves out there...stupid stupid stupid, they did the right thing, they registered with the FDA.

https://www.johnsonc...om/category/fda

I'm looking for the clean room video.  Look what I found while searching, the complaint against JC, its about the drug part of it all, nicotine, replacement, they even submitted reviews as evidence.  Christopher, heads up on this, the forums could be as well.  

http://www.fda.gov/I...s/ucm225206.htm

"As presently labeled and promoted, these Johnson Creek Smoke Juice products violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, Johnson Creek Smoke Juice products are unapproved new drugs marketed in the United States in violation of section 505 of the Act (21 U.S.C. § 355) and are misbranded under section 502 of the Act (21 U.S.C. § 352).

Both the "drug" and "device" definitions in sections 201(g) and 201(h) of the Act (21 U.S.C. §§ 321(g) and (h)) encompass products intended either to affect the structure or function of the body or to cure, mitigate, treat, or prevent disease. Based on our review of the Johnson Creek Smoke Juice products and their associated labeling and promotional materials, these products are drug-device combination products, with a drug primary mode of action. Statements in labeling and promotional materials, including your Internet website at www.johnsoncreeksmokejuice.com. that reflect these intended uses for the products you market include, but are not limited to, the following:"

Edited by FTJoe, 09 September 2010 - 04:37 PM.


#73 OFFLINE   BEERCITYVAPRZ

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Posted 09 September 2010 - 04:45 PM

View PostChristopher, on 09 September 2010 - 12:26 PM, said:

I just want to make it clear to everyone that I'm all for regulation and improved safety of electronic cigarettes (of course) My worry is about a ban or handing over the technology to the same people that have been killing us for years.

Judging by the articles here it sounds like the FDA may be changing their stance on things, but the lawsuit isn't over and my products are still getting seized at the boarder. So while they may appear to only be going after suppliers making false health claims and adding ED drugs into their liquid that isn't the case. We don't make any health claims in our store, in fact we where one of the FIRST American suppliers to add warning labels, yet monthly our products are taken by the FDA. Last time I checked my hardware didn't contain any E Liquid.
I totally agree with this Chris. the hardware shouldn't be siezed at all especially batteries.

#74 OFFLINE   FTJoe

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Posted 09 September 2010 - 04:55 PM

Me too.  If you read the FDA complaint against Johnson Creek I just posted (I'll be happy when my juice ships) they are complaining about drugs in the juice (nic).  They are complaining about drugs which means drug delivery is not far behind.  Am I over-reacting?  I hope so.  But I have 180 ml of my JC juice on the way!!!!

#75 OFFLINE   mcquinn

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Posted 09 September 2010 - 05:02 PM

It looks from the letter they sent Johnson Creek that if you just list your products and leave out all the other stuff you would not be in violation.As the complaint was they were making claims based on customer testimonials.The other stuff could be in a forum seperate from the store site.

#76 OFFLINE   FTJoe

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Posted 09 September 2010 - 05:17 PM

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

http://www.fda.gov/I...010/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/...ion/what_is_gmp

Edited by FTJoe, 09 September 2010 - 05:19 PM.


#77 OFFLINE   Christopher

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Posted 09 September 2010 - 05:20 PM

View PostCompenstine, on 09 September 2010 - 04:05 PM, said:

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)

#78 OFFLINE   Altmed

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Posted 09 September 2010 - 05:37 PM

View PostChristopher, on 09 September 2010 - 11:05 AM, said:

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

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!

#79 OFFLINE   mcquinn

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Posted 09 September 2010 - 05:45 PM

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.

#80 OFFLINE   LoriHNC

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Posted 09 September 2010 - 05:52 PM

View PostAltmed, on 09 September 2010 - 05:37 PM, said:

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.