Enigma, I totally agree with you on desperation. Unfortunately, they have our tax dollars working for them.
FDA acts against electronic cigarette distributors
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I'm surprised BP and BT, what ever large corporation capable of meeting the FDA requirements hasn't picked up the scent of a new market in e-cigarettes. If one has noticed, it would boost the research and development process to a new degree. These corporate giants could swallow the whole e-juice business in a very short time.
There are a lot of ejuice distributors, but not one facility that all of them could use if necessary to understand and comply with FDA regulations? Couldn't one facility provide the resource to all or any e-juice start- up, or established businesses? I'm not involved in investing in opportunity and there seems to be a vacuum here, presently no one is leading the way. Are there such "knowledgeable groups" available, and would that work? There must be some businesses that capitalize on helping businesses meet FDA regulations.
There are a lot of ejuice distributors, but not one facility that all of them could use if necessary to understand and comply with FDA regulations? Couldn't one facility provide the resource to all or any e-juice start- up, or established businesses? I'm not involved in investing in opportunity and there seems to be a vacuum here, presently no one is leading the way. Are there such "knowledgeable groups" available, and would that work? There must be some businesses that capitalize on helping businesses meet FDA regulations.
My mother works for a small family-owned natural food store. I've heard so many stories of the stupid things the FDA pulls it's insane. Most recently a Kombucha drink, which since fermented contains alcohol...and may contain more than the .5% allowed because some bottles were found to continue to ferment and raise the alcohol level. So it's been pulled.
The craziest one was ear candles... If you havent heard of them, they're basically a strip of cloth, coated in wax and rolled into a long cone. Theory is that you insert the pointed end in your ear, light the other end like a candle of sorts, and the vacuum created inside will pull any toxins or whatnot out of the ear. Some swear by them, others say they don't do a thing. Regardless, the FDA have banned them. The stores had to pull all ear candles from the shelves and are no longer allowed to sell them. Seems the former ear candle manufacturers now sell a very interestingly designed "incense holder" now, that is made from wax coated strips of fabric rolled into a long cone.
Stevia, a natural sweetener just recently allowed to be sold as such, went back and forth with the FDA for some time. They had to sell it as a dietary supplement, and could not be labeled as a sweetener until they received approval from the FDA. I believe at one time it was dangerously close to being banned. I had purchased several bottles of flavored liquid stevia and asked my mom why in the world was it labeled a supplement, as I thought it was just a sweetener, and her answer was it is all because of the FDA's rules, there is so dietary supplement value, it just makes things sweet....but they couldnt say that.
It's totally insane. If anything else happens with this whole FDA thing and ecigs, I sure hope I can still get 'laser pointers', 'incense vaporizers' and 'pesticide juice' <wink wink>
The craziest one was ear candles... If you havent heard of them, they're basically a strip of cloth, coated in wax and rolled into a long cone. Theory is that you insert the pointed end in your ear, light the other end like a candle of sorts, and the vacuum created inside will pull any toxins or whatnot out of the ear. Some swear by them, others say they don't do a thing. Regardless, the FDA have banned them. The stores had to pull all ear candles from the shelves and are no longer allowed to sell them. Seems the former ear candle manufacturers now sell a very interestingly designed "incense holder" now, that is made from wax coated strips of fabric rolled into a long cone.
Stevia, a natural sweetener just recently allowed to be sold as such, went back and forth with the FDA for some time. They had to sell it as a dietary supplement, and could not be labeled as a sweetener until they received approval from the FDA. I believe at one time it was dangerously close to being banned. I had purchased several bottles of flavored liquid stevia and asked my mom why in the world was it labeled a supplement, as I thought it was just a sweetener, and her answer was it is all because of the FDA's rules, there is so dietary supplement value, it just makes things sweet....but they couldnt say that.
It's totally insane. If anything else happens with this whole FDA thing and ecigs, I sure hope I can still get 'laser pointers', 'incense vaporizers' and 'pesticide juice' <wink wink>
Chucklehead, where did you get that? It is so so wrong, but it made me chuckle. Somewhere in that comment, is repetition.
What makes you think that BP or BT aren't actively running studies and trials to test the effectiveness of the PV? If I were either of them, though, I wouldn't announce my activities - might set my competition to developing the same tech and a race to market-share would ensue.
Just because no news of development has come to the consumer's ears doesn't mean it's not happening.
Now, I SUSPECT (and yes, this may sound like conspiracy theory here!!!) that BP is working on developing a PV of their own - simply by putting various puzzle pieces together and stitching a story out of the holey cloth. Look....
-ANY approved NRT's are owned by BP
-The Alphabet Anti's get a TON of their funding from BP - and they're screaming for PV's to be removed 'until approved by the FDA'
-The FDA is HEAVILY influenced by BP, many of their advisors have ties to Pharma
-There was a study done by HNZ for a Dr. Rose (who has Pharma ties...can't remember which house) for a vapor-spewing device that will deliver nicotinated pyruvic acid deep in the lungs, using a similiar tech as the present PV - just none of that 'dangerous' antifreeze
-Everyone's INSISTANCE that these be labeled a drug-delivery device..
-Pharma's intent to lock nicotine into medicalization status in the UK
IMO, this latest press release is dual - 1) to respond to the favorable press the PV has been getting (WSJ, AP, etc...) and 2) the oral argument is coming up in the ongoing NJoy vs. FDA case. They like to drop their little bombshell press releases JUST as they need them to grease public opinion to their side of things.
Example of what should be put as a disclaimer:
Safety Information
E-cigarettes are not a medical device. It is a smoking alternative. Results will vary from user to user.
No claim is made for the cure of any disease or ailment.
No guarantee or other assurance is made covering the results of use through mentioned product.
Some people get excellent help for their symptoms, reporting instant benefits. Some people do not notice nor get any results.
Vaping is not an exact procedure, with results that cannot be predicted.
Do not use e-cigarettes as a substitute for professional medical treatment.
Use caution, and common sense with this product.
Safety Information
E-cigarettes are not a medical device. It is a smoking alternative. Results will vary from user to user.
No claim is made for the cure of any disease or ailment.
No guarantee or other assurance is made covering the results of use through mentioned product.
Some people get excellent help for their symptoms, reporting instant benefits. Some people do not notice nor get any results.
Vaping is not an exact procedure, with results that cannot be predicted.
Do not use e-cigarettes as a substitute for professional medical treatment.
Use caution, and common sense with this product.
Philip Morris was in negotiations with Ruyan last year OfficialWire: Philip Morris In Negotiations With Original E-Cigarette Company
They also have a 1991 patent on a similar device http://www.e-cigarette-forum.com/forum/e-cigarette-news/89143-bt-patents-e-cigarettes-1991-a.html
Big Tobacco isn't asleep at the wheel or stupid. Far from it.
As for Big Pharma...well if it gets regulated as a drug-delivery device and is subject to trials etc., that's who may very well run the market.
When ecig suppliers market PVs as stop smoking aids, they are treading on dangerously thin ice. Suppliers are not in the business of treating nicotine addiction or providing materials specifically designed for smoking cessation. While some of us may have used PVs to gradually taper off of nicotine, we have done so independentlyin the same way that a smoker might monitor and titrate their cigarettes during the day in order to try to cut down. But a supplier who markets and sells a program for doing this (eg, Ecigarette Direct) is clearly playing directly into the FDAs hands.
Some of the issues raised in the letters seem legitimate. I don't think anyone would argue, for example, that it's important to have good quality control, accurate expiration dates on juice, etc. On the other hand, some of the violations and references cited by the FDA are contradictory and confounding.
An E-cig is a device that appeals to current smokers. It shouldnt be used by anyone else! It makes sense, from a suppliers standpoint, to market the product by helping smokers understand how it is similar or different from traditional cigarettes. If all of this language is cut out (including the testimonials of satisfied customers who are understandably delighted to have shed the expense, ill health effects, and social ostracism associated with smoking) then the FDA (and others) will no doubt come back with concerns that PVs are being marketed to non smokers (and children).
If you focus on PVs as a alternative, you play into the notion that ecigs are being sold (implicitly or otherwise) as a way to quit or cut down on smoking tobacco. But if you focus on the pleasure of vaping by itself (the durability of the PV model, the flavor of the juice, the thickness of the vapor, the lack of lingering odor in the air or on your clothing, etc) dont you set yourself up for a different kind of headache?
Easy to use! Tastes great! Clouds of thick tasty vapor! Comes in 15 different flavors! Sound familiar? The save-the-children fanatics will have a field day because now youre just trying to hook non smokers by selling them on a shiny, tasty, economical, and highly addictive product.
This is a no win situation and smells an awful lot like a set up. I agree with a
previous poster who wondered why the FDA is flexing its muscles when the drug delivery issue is still in litigation. Is there any substance to their threat to shut down the companies who dont address and "correct these violations" within 15 days?
Some of the issues raised in the letters seem legitimate. I don't think anyone would argue, for example, that it's important to have good quality control, accurate expiration dates on juice, etc. On the other hand, some of the violations and references cited by the FDA are contradictory and confounding.
An E-cig is a device that appeals to current smokers. It shouldnt be used by anyone else! It makes sense, from a suppliers standpoint, to market the product by helping smokers understand how it is similar or different from traditional cigarettes. If all of this language is cut out (including the testimonials of satisfied customers who are understandably delighted to have shed the expense, ill health effects, and social ostracism associated with smoking) then the FDA (and others) will no doubt come back with concerns that PVs are being marketed to non smokers (and children).
If you focus on PVs as a alternative, you play into the notion that ecigs are being sold (implicitly or otherwise) as a way to quit or cut down on smoking tobacco. But if you focus on the pleasure of vaping by itself (the durability of the PV model, the flavor of the juice, the thickness of the vapor, the lack of lingering odor in the air or on your clothing, etc) dont you set yourself up for a different kind of headache?
Easy to use! Tastes great! Clouds of thick tasty vapor! Comes in 15 different flavors! Sound familiar? The save-the-children fanatics will have a field day because now youre just trying to hook non smokers by selling them on a shiny, tasty, economical, and highly addictive product.
This is a no win situation and smells an awful lot like a set up. I agree with a
previous poster who wondered why the FDA is flexing its muscles when the drug delivery issue is still in litigation. Is there any substance to their threat to shut down the companies who dont address and "correct these violations" within 15 days?
It would be best to follow the guidelines that Judge Leon so conveniently provided in his opinon document SE vs. FDA. He outlined all the things that SE did say and did not say in their advertisement and said that as presented, their product is not a drug-delivery device. I quoted from (and provided link to) that document in this post:
http://www.e-cigarette-forum.com/fo...tters-read-them-dont-panic-2.html#post1868248
NOTE: You will need to scroll down past my explanation of where we are in the Federal court case.
Is it because the nicotine is part of the tobacco and is released by burning?
The days when the cigarette companies could claim, with a straight face, that cigarettes werent addictive (or harmful) are long past. Without question, the use of tobacco cigarettes affect the structure or function of the body. Without question, regular use of tobacco cigarettes can lead to craving, tolerance, and other symptoms associated with physical addiction.
While there are certainly occasional smokers and there are smokers who actually enjoy the experience of smoking tobacco, there are also smokers (like me) who continued to smokewithout much enjoymentdespite the ostracism and hassles associated with smoking bans, and despite the additional costs incurred by ever-increasing federal, state, and local tobacco taxes. We kept smoking because we were addicted and because, if we'd attempted to quit in the past, our efforts proved unsuccessful.
In that sense, cigarettes can also be viewed as a method for treating drug withdrawal because as long as you continue to ingest the drug, the withdrawal symptoms abate. PVs are a drug delivery device? If so, then shouldn't tobacco companies be subject to the same regulations?
The days when the cigarette companies could claim, with a straight face, that cigarettes werent addictive (or harmful) are long past. Without question, the use of tobacco cigarettes affect
While there are certainly occasional smokers and there are smokers who actually enjoy the experience of smoking tobacco, there are also smokers (like me) who continued to smokewithout much enjoymentdespite the ostracism and hassles associated with smoking bans, and despite the additional costs incurred by ever-increasing federal, state, and local tobacco taxes. We kept smoking because we were addicted and because, if we'd attempted to quit in the past, our efforts proved unsuccessful.
In that sense, cigarettes can also be viewed as a method for treating drug withdrawal because as long as you continue to ingest the drug, the withdrawal symptoms abate. PVs are a drug delivery device? If so, then shouldn't tobacco companies be subject to the same regulations?
The problem is, based on the comments from the FDA, they want BATCH testing, not random or periodic samples. For batch testing to be remotely feasible and economically doable, they would have to make HUGE batches of each different flavor and nicotine% liquid. For most, this would necessitate decreasing flavor choices, nicotine% selections, and totally eliminate mix-to-order custom blends. And that would still probably amount to more than a 5-10% cost increase.
And for many, this would necessitate going out of business. Hopefully, batch testing is only considered a requirement for products the FDA considers drugs, and in the future if/when they officially consider some products reduced-harm tobacco products, random sample testing would be sufficient.
Yeah, I agree, but I was only pointing out that it wasn't just about user comments.
Have you seen this recent thread? It does appear BT has picked up the scent.
http://www.e-cigarette-forum.com/fo...20551-attention-richmond-virginia-vapors.html
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The FDA has entirely too much time on thier hands. We need to vote for smaller, less in-your-face government. Let's slash the FDA budget by half, get back to fiscal responsibility, get gov off our backs, and get back to being the land of the free. I'm a registered life-long dem, but I'm voting republican next time. The FDA is big gov at it's worst.
Quick history lesson: The FDA did try to regulate cigarettes as drug-delivery devices. The case was Brown & Williamson v. FDA. B&W won. The court found that there was no law giving the FDA the power to regulate a tobacco product as if it was a drug, intended to treat, prevent, or mitigate a disease. The court said if that were true, the only action FDA could take would be to toally remove them from the market, and Congress was not in favor of that.
Now, the FDA does have the power to regulate tobacco cigarettes, but not under the Food, Drug, and Cosmetics Act (FDCA). Congress passed a new law last year, the Family Smoking Prevention and Tobacco Control Act (Tobacco Act.) This was passed shortly after Smoking Everywhere filed its suit, and Judge Leon decided (rightfully, since it is now the law) to include it in the case. Smoking Everywhere & NJOY (now just NJOY, because SE has dropped out due to financial difficulties) argued that their products are recreational products used as an alternative to smoking. FDA argued that they are drug-delivery device combinations that they can regulate under FDCA. Judge Leon granted an injunction against FDA product seizures. His opinion document stated that since the nicotine in e-cigarettes is extracted from tobacco, the products meet the definition of "tobacco product" under the Tobacco Act (any product made from or derived from tobacco). Therefore FDA should feel free to regulate them, but not under FDCA, but rather under the Tobacco Act.
The FDA's recent actions constitute an attempt to make an end run around the court system. They are behaving as if they have won the case, when the case is years away from coming to trial.
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No theraputic claims? Quit Smoking Naturally | Stop Smoking Naturally with Nicoban by Healthy Choice Naturals
Hidden in the source code, but not visible on screen:
It is time we all went to court and take the fight to them before we are all screwed over!
The FDA's opinion is a drug delivery device.
The other side it is a tobacco product!
either way the FDA will get regulatory authority!
I say it's neither!
If we don't take our freedom of choice fight Straight to them soon we are gonna loose either way the outcome of the current case.
My ecig is a mini theatrical prop to mimic smoking.
Now let's argue intended use! (nobody can win)
The FDA opinion of a drug delivery device is absurd
(soda)can containing liquid which delivers caffeine when you pour into your mouth. (drug delivery device?)
It is time we ALL collectively sue the FDA !
They are attempting to force there opinion (its a drug delivery device!) on us.
I SAY NO !
NO NO NO
We need to put the analog Vs. ecig argument on the legal table!
and force a judge to attempt to violate my freedom of choice!
if the current case ends on the tobacco product side (the e-liquid)
Then we should not stand for some new insane TAX either!!
It is time to stand up
No taxation without representation!
No violating my Freedom of choice!
let's go a Step further !
I say "BAN THE FDA" out of my personal life !
WARNING! this product has not and will NEVER will be approved by the Monstrous, Out of Control, Government Taxing Mechanism of Big tobacco or Big Pharma Known as the FDA !
Dear American vapers
greetings and words of support from Polish vapers. We're watching the situation in the US closely. Here in Poland PVs are still on the market, but who knows for how long. Thanks for your important posts, Vocalek et all. We had similar fight earlier this year in our Parliament. There was a proposition of banning the e-cigs totally, but after some pro-PV campaign, 2/3rd of the Parliament voted nay.
We're keeping our fingers crossed. Although it seems to be a kind of David-Goliath confrontation, we must remember who was the final winner in the Bible. I hope the history will repeat.
greetings and words of support from Polish vapers. We're watching the situation in the US closely. Here in Poland PVs are still on the market, but who knows for how long. Thanks for your important posts, Vocalek et all. We had similar fight earlier this year in our Parliament. There was a proposition of banning the e-cigs totally, but after some pro-PV campaign, 2/3rd of the Parliament voted nay.
We're keeping our fingers crossed. Although it seems to be a kind of David-Goliath confrontation, we must remember who was the final winner in the Bible. I hope the history will repeat.
I have wondered why Jelly Belly has not swarmed in to the e-juice market. They are the kings of flavor mixing. Do they get FDA approval for every single flavor they have?
We don't have to worry if FDA takes our PVs off the market. There is a cure for smoking that has a money-back guarantee!
Nicodyne: Herbal Quit Smoking Solution
Glad to see that there were absolutely no unsubstantiated health claims made for this product.
There was no price listed on the landing page. I had to fill out a form giving my name, address, and telephone number before being taken to the ordering page. Naturally I entered totally truthful information. (555 Oz St., Emerald City, KS)
They were offering a 15-day free trial!
Subscription? $80 per month? Sucha Bahghen!
Nicodyne: Herbal Quit Smoking Solution
Glad to see that there were absolutely no unsubstantiated health claims made for this product.
There was no price listed on the landing page. I had to fill out a form giving my name, address, and telephone number before being taken to the ordering page. Naturally I entered totally truthful information. (555 Oz St., Emerald City, KS)
They were offering a 15-day free trial!
Subscription? $80 per month? Sucha Bahghen!
Someone posted a call for participants in an Altria study of e cigs. They are offering paid participation for residents of Richmond VA who are e cig users. To think that BT is asleep at the wheel on this one is just naive.
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