E cigarettes do not need FDA Approval

[dc2k08]

Originally Posted by taleywhacker

Everyone on this forum needs to chill. The only reason that e-cigarettes would need approval from the FDA is to be able to legally market the product as healthier or as a cessation method...
...E-cigs are here to stay, and the FDA has no jurisdiction to do anything about it.

I would hope that your beliefs are valid but I can't be so sure. I came accross this piece recently: http://www.naturalnews.com/025606.html

The FDA has effectively banned a naturally-occurring form of vitamin B6 called pyridoxamine by declaring it to be a drug, reports the American Association for Health Freedom. Responding to a petition filed by a drug company, the FDA declared pyridoxamine to be "a new drug."

Now, any nutritional supplements containing pyridoxamine will be considered adulterated and illegal by the FDA, which may raid vitamin companies and seize such products. See the history of FDA raids on vitamin companies here: http://www.naturalnews.com/021791.html

Pyridoxamine occurs naturally in fish, chicken and other foods (http://en.wikipedia.org/wiki/Vitamin_B6), putting the FDA in the strange position of banning a substance from dietary supplements even though it is already present in the food supply.

It's not the first time the FDA has declared a natural molecule to be a "drug" while attacking nutritional supplements that contain the same molecule. A similar story unfolded with red yeast rice and the lovastatin molecules it contains that lower high cholesterol. The drug companies engaged in biopiracy, ripping off the molecule from red yeast rice to make their now-famous "statin drugs." Once the statin drugs were patented, Big Pharma and the FDA went after red yeast rice, claiming the supplement was "adulterated with pharmaceuticals."

Now on the the website that lists Refusal Actions by FDA as Recorded in OASIS - the reason given for the refusal for some consignments of electronic cigarettes is that they are both "unapproved" and "not listed".

Unapproved means that it is seen by the FDA as a 'new drug'. Do you think that this is because the box/manual of this devices, some of which were from the popular Joye manufacturer, had cessation device labels or made health claims? and that as long boxes are not marked as such then users in the US will be able to circumvent the FDA?

Judging not least by the letter federal scientists working at the FDA recently sent to Obama accusing the FDA of being corrupted, It seems that the FDA have largely been able to get away with whatever they have wanted in the past and the health and welfare of the citizens of the US is not always the key motive or a priority for their decisions and that the generous hand of Big Pharm has a presence in their ranks.

I fear If the FDA want these banned they'll find a reason to make it so and no amount of angry letters to .gov will change that course of action. Labelling them as cessation devices or making 'healthy' claims just spurs the process.

[Lithium1330]

Originally Posted by dc2k08

I would hope that your beliefs are valid but I can't be so sure. I came accross this piece recently: FDA Declares Form of Vitamin B6 a Drug, Effectively Banning Pyridoxamine from Dietary Supplements by Mike Adams the Health Ranger



Now on the the website that lists Refusal Actions by FDA as Recorded in OASIS - the reason given for the refusal for some consignments of electronic cigarettes is that they are both "unapproved" and "not listed".

Unapproved means that it is seen by the FDA as a 'new drug'. Do you think that this is because the box/manual of this devices, some of which were from the popular Joye manufacturer had that they were cessation devices or made health claims? and that as long boxes are not marked as such then users in the US will be able to circumvent the FDA?

Judging not least by the letter federal scientists working at the FDA recently sent to Obama accusing the FDA of being corrupted, It seems that the FDA have largely been able to get away with whatever they have wanted in the past and the health and welfare of the citizens of the US is not always the key motive or a priority for their decisions and that the generous hand of Big Pharm has a presence in their ranks.

I fear If the FDA want these banned they'll find a reason to make it so and no amount of angry letters to .gov will change that course of action. Labelling them as cessation devices or making 'healthy' claims just spurs the process.

You are SO right, if they want to ban it, they can ban it, as simple as that, as mentioned, two problems were founded in the seized packages: NOT LISTED and UNAPPROVED if the package is labeled as "Vaporizers" (which they are) the first problem is solved, because "Vaporizers" are listed, but as soon as FDA notice that some "Vaporizers" are used primary as a "new drug" delivery system, they can still claim that are UNAPPROVED, the liquid and cartridges with nicotine have no doubt to me that for them are a "new drug" and thus UNAPPROVED.

I don't know if the FDA will enforce the ban on this, but IMO if they want to do it, they can do it, because for them this is a "new drug" an the devices are a "new drug" delivery system, whatever you call it.

Can happen that even selling the device apart from the nicotine they can ban it, because the primary use of the device is for a "new drug", until the "new drug" can be legally sold, they can ban the device too if they want.

I'm not saying they gonna enforce the ban, but IMHO if they want to do it, they can and also IMHO this devices are already banned in the US, but this ban it is not enforced.

Some of you may say that they are not banned, because vaporizers are not banned, but the problem is that maybe is to late for THIS vaporizers to pass as a valid vaporizer with another primary use than a "new drug" delivery system, some may say that are not banned just because they don't have problems with the FDA labeling the device as "Vaporizer" but for me this is just because "Vaporizer" don't call the eyes at customs and the ban is not havely enforced.

If at any time they enforce the ban, the only solution will be to regulate this "new drug", of course if a very large number of people use this devices, enforce a ban will be more dificult to do.

If I were you, I would start to think in a good plan B, just in case.

That said, I'm off too from this subject on this forum just to become a reader as TB does.

[LaceyUnderall]

Originally Posted by dc2k08

FDA Declares Form of Vitamin B6 a Drug, Effectively Banning Pyridoxamine from Dietary Supplements by Mike Adams the Health Ranger
[url="http://www.pharmamanufacturing.com/industrynews/2009/008.html"]

That was some interesting reading there. Thank you. What I find interesting is that FDA scientists are heading a revolt and that article was probably hard to find. With everything we are seeing with the peanut butter fiasco, the big pharm drugs that are really hurting people... it WILL be interesting to see how this big "snow globe" settles after the "big shake".

There is no doubt that the FDA has assumed so much power that they simply cannot keep up with themselves. And unfortunately, the US health system has become so profit driven, that health and safety has become a lost priority. It is very promising, to me at least, that Obama is putting together a commission to evaluate what has happened over at the FDA regarding the peanut butter issue we are having. I *cross my fingers* hope that the discovery of that is the FDA has too much control and that power needs to be dispersed. Wow! The next four years are going to be an interesting ride that's for sure.

Again thanks.

[TribbleTrouble]

Originally Posted by Lithium1330

You are SO right, if they want to ban it, they can ban it, as simple as that, as mentioned, two problems were founded in the seized packages: NOT LISTED and UNAPPROVED if the package is labeled as "Vaporizers" (which they are) the first problem is solved, because "Vaporizers" are listed, but as soon as FDA notice that some "Vaporizers" are used primary as a "new drug" delivery system, they can still claim that are UNAPPROVED, the liquid and cartridges with nicotine have no doubt to me that for them are a "new drug" and thus UNAPPROVED.

I don't know if the FDA will enforce the ban on this, but IMO if they want to do it, they can do it, because for them this is a "new drug" an the devices are a "new drug" delivery system, whatever you call it.

Can happen that even selling the device apart from the nicotine they can ban it, because the primary use of the device is for a "new drug", until the "new drug" can be legally sold, they can ban the device too if they want.

I understand that the government can basically do what it wants to do. All I know is that in the town I live in, there is a head shop on practically every corner downtown. They are all chock full of paraphernalia that everyone knows the use for, but yet they are perfectly legal to sell because of the ambiguous naming and marketing of them. If the FDA will not stop them, then the same approach can & will work for our Vaporizers. That is just my opinion, of course. I feel the FDA is more concerned about the liquid than the device. If manufacturers & suppliers insist on keeping the two together, they will get both banned. Separate them, and we get to keep our gear while the e-liquid companies hack through the FDA jungle. A better liquid will come from it, and all the while we keep our vapor paraphernalia.

[taleywhacker]

I felt pretty good when I posted this now I am all worried again. I wont read this post anymore. Everyone is a no it all, and no one has any kind of a background to say for sure what the truth is(including myself). Just like people should not use this forum for medical advice, people should not use this forum for legal advice. That being said I have enlisted the help of an attorney who specializes in dealing with the FDA. All this back and forth does no one any good. I am sorry for creating this thread.

[TribbleTrouble]

Originally Posted by taleywhacker

I felt pretty good when I posted this now I am all worried again. I wont read this post anymore. Everyone is a no it all, and no one has any kind of a background to say for sure what the truth is(including myself). Just like people should not use this forum for medical advice, people should not use this forum for legal advice. That being said I have enlisted the help of an attorney who specializes in dealing with the FDA. All this back and forth does no one any good. I am sorry for creating this thread.

That is a wierd response. All I can say to that is "If you are scared of the heat, you better not play around in the Kitchen"! It is a brave new world of vapor, people. We need to talk about & discuss subjects like this if we want to keep the luxury of "Personal Vaporizers". Don't get scared, get active!!! I wish someone from the FDA was actually a member of this forum so that they might straighten us out on this subject.

[ZambucaLu]

Originally Posted by TribbleTrouble

I understand that the government can basically do what it wants to do. All I know is that in the town I live in, there is a head shop on practically every corner downtown. They are all chock full of paraphernalia that everyone knows the use for, but yet they are perfectly legal to sell because of the ambiguous naming and marketing of them. If the FDA will not stop them, then the same approach can & will work for our Vaporizers. That is just my opinion, of course. I feel the FDA is more concerned about the liquid than the device. If manufacturers & suppliers insist on keeping the two together, they will get both banned. Separate them, and we get to keep our gear while the e-liquid companies hack through the FDA jungle. A better liquid will come from it, and all the while we keep our vapor paraphernalia.

I have said this myself TT. If a pothead can walk into a shop and buy a device known to be specifically used for an illegal substance, I don't see how, in the end, ecig "paraphernalia" will be outlawed either.

If the FDA (or whoever) ultimately decides the eliquid is illegal, then that is another issue to contend with....but I choose not to worry about that until the time comes....and even then I won't worry....I'll just do what I got to do.

Too many "negative Nancys" (as my son says) speculating and focusing on the negative side here.

As I always say....true, a glass can be half empty or half full; that is reality. But whatever you choose to call it determines if you are an optimist or pessimist. Think about it! Anyhoo, I know the (possible) reality, but I choose to be an optimist about it....as Lacey and some others here as well.

I think Lacey was on the right track with the herbal stuff though. I mean, don't they say something like "these statements have not been approved by the FDA"....or something like that? Then we wouldn't have to worry about marketing and all that. On the other hand, who would regulate what we are inhaling, say? God knows what it could end up containing....lol

Ah well, I vape and hope for the best. Seems like that's all we can do until all this gets straightened around.

Lu

[taleywhacker]

I am not scared, I am very confident that e-cigs are here to stay. The forum is full of speculation and little actual facts. I am finished speculating. I want the facts and I will find them. I wont bother posting them here, because some no it all will pick every word apart. If someone is interested in the facts, PM me, and I would be happy to discuss it (give me some time to get the facts though). I don't want anyone to misinterpret the tone of my posts. I am not upset or anything like that. I love this forum, without it I would not be doing what I am today. But there are two things that this forum should not be used for, medical advice and legal advice. That being said, I made a mistake starting this thread, as there are people out there that will read it and think that the information contained is correct. The bottom line is, that until one of us actually gets shut down by the FDA, we can only speculate.

Sam, I am a "glass is half full" kind of guy.

[LaceyUnderall]

If anyone is interested... Lithium has started a thread on RTV. Over there, we are going to discuss the actual wording of the form letter.

If you don't have empirical data or a court ruling to back up what you have to stay, then please, only read. Don't post. (Hope you don't mind Lith that I want to keep that thread real). Legal interpretation of the FDA letter

Taley... I do hope you will join us. I have a "half full" cup here that I would like to add to your "half full" cup.

[ZambucaLu]

This was just referred to by OutWest in another thread. Pretty interesting:

OASIS REFUSALS INDUSTRY 66

Lu