FDA Spokesperson Rita Chappelle Shoots Down Both the Device and The Nicotine For a Ban

[Faethe]

Unfortunately since there are no true US manufactures, only Chinese they probably never concerned themselves with the FDA.

In reality some of the larger companies like njoy are the ones that have the most at risk in the US and should have been on the ball as they are the ones marketing the products to the US without going through proper channels. You would think with the amount of money that was needed to start njoy they would have consulted with some attorneys. Maybe they did?

Who knows, but I just wish people would stop making these claims about being safe and healthy! Basically these suppliers are spitting on the FDA, when making claims like this and ruining it for everyone else.

I think that logically they may think politicizing e-cigarettes is a bit ridiculous given that analogs are legal.

 

[CandyGirl]

Who knows, but I just wish people would stop making these claims about being safe and healthy! Basically these suppliers are spitting on the FDA, when making claims like this and ruining it for everyone else.

exactly! then to have the gall to come in here and want us to hold the presses while their "healthy" websites remain unchanged?

 

[Legato525]

Why would anyone in their right minds use such a dangerous, untested device?8-o

Just because a product has not gone through safety testing does not mean it is not a safe device. Common sense can tell you whether or not a device is safe. And as an alternative to smoking cigarettes, can't get much more unsafe than that.

 

[markab]

BINGO!
This short term, get rich quick approach, that most, if not all e-cig manufacturers have taken, has seriously jeopardized the future of a potentially life saving smoking alternative.

Mark

$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

 

[KDMickey]

Legato-sama, (sorry, couldn't help it),

First, thank you for getting the ball rolling with contacting test labs, etc. etc. Please start a new thread about any info you find. I think that, by working together with suppliers, consumers and suppliers may find a way to get the pull we need to go legal. I know that funding is and will be the biggest challenge to getting e-cigs legal in the US.

Please feel free to dump a workload on me if you need to. I have already spent a lot of time researching things like mad.

Cheers,
-Mickey

 

[Sun Vaporer]

As consumers, we have just as much power as the suppliers. The blame game does not solve anything. Suppliers and consumers need to stand together to make sure the product we love does not go away. If all the suppliers start contacting the FDA for pending approval, we might be able to postpone the ban until testing can be done.

Lego--Unfortunalty we do not have any standing in an FDA application as a Consumer. Only the "Claimant" has standing to make an application. We as consumers can not step in for them. The claimant is the entity that actually makes the product and is the only one that can advance anything before the FDA in the approval process. We can donate money for studies to be done--but the actual manufacture has to have the studies done on their devices under very strict quality controls and mandates set forth by the FDA. I wish we could, but the way the system is set up, we, as consumers simply can make no filings. We, as conusmers can indeed have our own testing done to be used as "secondary evidence" in support of the Claimant, but it would not be binding on the FDA in their approval process--but then again it would not hurt. Bottom line is the manufactures now have to get on the right track and start the application process---------Sun

 

[Legato525]

Lego--Unfortunalty we do not have any standing in an FDA application as a Consumer. Only the "Claimant" has standing to make an application. We as consumers can not step in for them. The claimant is the entity that actually makes the product and is the only one that can advance anything before the FDA in the approval process. We can donate money for studies to be done--but the actual manufacture has to have the studies done on their devices under very strict quality controls and mandates set forth by the FDA. I wish we could, but the way the system is set up, we, as consumers simply can make no filings. We, as conusmers can indeed have our own testing done to be used as "secondary evidence" in support of the Claimant, but it would not be binding on the FDA in their approval process--but then again it would not hurt. Bottom line is the manufactures now have to get on the right track and start the application process---------Sun

I never hurts to stretch the truth a little bit to find the information you need. As far as the FDA knows I am a potential reseller who is looking to sell legally. And it might be possible that not of of that is a lie.

 

[Sun Vaporer]

I never hurts to stretch the truth a little bit to find the information you need. As far as the FDA knows I am a potential reseller who is looking to sell legally. And it might be possible that not of of that is a lie.

Lego--part of the FDA approval process is a full inspection and evaluation of the "Drug" and the actual facility where the 'Durg" is made---how can you get around that when you do not have a facility that is manufacturing "your drug".

We could go round and round with this, but all I can say is I am truly disappointed that it has to come down to this looming ban and that there is not much in the short term that we can do about it. There is no stretching of the truth when it comes to filing documents under the pains and penalties of perjury with a Federal Agency. No one is getting very far with that. You are dealing with the appoval of a drug--make no doubt about it--it is serious busniess that takes a lot of time and money----Sun

 

[skidamarink]

I was going to try to get my father to start on e-cigs but with a ban circling over this new market it seems that i should wait. I just started e-cigs a few days ago and i'm having a hard time just trying to get liquid because everyone seems to be out of stock.

 

[Legato525]

I Understand your point. But to clear the air, I am not looking for approval of a "drug", which I know the device itself can be a drug. I am looking for approval of a product that is considered a novelty item that makes no health claims that would make it a drug under FDA standards. Nicotine is not a problem, because it is legal to sell to the public, if you have proper certification. An example of a novelty VS. drug is, Absinthe contains wormwood, which contains a chemical known as thujone. Thujone is illegal and banned under federal law based on the FDA. Now I order Absinthe all the time from vendors who sell to me in the U.S. Working with these vendors, I have discovered that banned chemicals (Not including type 1,2 and 3 illegal narcotics) can be sold as imports under U.S. statues, as long as the item is for novelty use only. If you import an item with a banned chemical for consumption, customs will seize it under FDA, BUT if the item is a novelty item, it can bypass FDA standards. I know you are well versed on the subject, I would like your opinion on this idea.

 

[Sun Vaporer]

I Understand your point. But to clear the air, I am not looking for approval of a "drug", which I know the device itself can be a drug. I am looking for approval of a product that is considered a novelty item that makes no health claims that would make it a drug under FDA standards. Nicotine is not a problem, because it is legal to sell to the public, if you have proper certification. An example of a novelty VS. drug is, Absinthe contains wormwood, which contains a chemical known as thujone. Thujone is illegal and banned under federal law based on the FDA. Now I order Absinthe all the time from vendors who sell to me in the U.S. Working with these vendors, I have discovered that banned chemicals (Not including type 1,2 and 3 illegal narcotics) can be sold as imports under U.S. statues, as long as the item is for novelty use only. If you import an item with a banned chemical for consumption, customs will seize it under FDA, BUT if the item is a novelty item, it can bypass FDA standards. I know you are well versed on the subject, I would like your opinion on this idea.

Legato--I understand what you are saying and that is one thing as a novelty for personal consumption--you run afowal with the law when it comes to resale and leave the sphere of yourself. Anytime you put a product into commerce----you better be on the up and up------Sun

 

[Ramblin]

Just because a product has not gone through safety testing does not mean it is not a safe device. Common sense can tell you whether or not a device is safe. And as an alternative to smoking cigarettes, can't get much more unsafe than that.

I left off my sarcasm tag.

To bad the deficit for common sense is so severe in our nanny state government.

 

[Legato525]

Legato--I understand what you are saying and that is one thing as a novelty for personal consumption--you run afowal with the law when it comes to resale and leave the sphere of yourself. Anytime you put a product into commerce----you better be on the up and up------Sun

Absolutely right. I guess I used a poor example. I know were on the same page, just different paragraphs.

 

[TropicalBob]

So, "common sense" is to let any manufacturer of a new drug and drug-delivery device enter the U.S. and sell whatever it pleases? No oversight. No testing. No regulation. No side effects knowledge. No labeling. No warnings. Unknowns galore.

That's your idea of common sense?

 

[Ramblin]

So, "common sense" is to let any manufacturer of a new drug and drug-delivery device enter the U.S. and sell whatever it pleases? No oversight. No testing. No regulation. No side effects knowledge. No labeling. No warnings. Unknowns galore.

That's your idea of common sense?

You yourself talked about turning a lady on to ecigs in a local tobacco store. What was your motivation for doing so?

Stories abound about people turning on friends and co workers. What was their motivation for doing so? To save them money? To save their health?

If it was to save them money, how dare you deprive the government and big tobacco of their money. How dare you push untested devices on complete strangers accosting them in stores.

 

[Kendra]

So, "common sense" is to let any manufacturer of a new drug and drug-delivery device enter the U.S. and sell whatever it pleases? No oversight. No testing. No regulation. No side effects knowledge. No labeling. No warnings. Unknowns galore.

That's your idea of common sense?

Actually, it's kind of my idea of common sense, even though I am sympathetic to your viewpoint. As adults, we should be able to regulate what we use in our bodies and do our own research. Yes, I'm aware that some will not do their own research, but they don't do their own research now.

I'm a libertarian (if you haven't guessed) and I'm entirely tired of the government coming down to regulate us and tax us and protect us from ourselves.

There are many things that are legal and dangerous and many things that are illegal and available on the street. If this gets banned, it is also likely that there will be more people trying to make their own nicotine juice to save money and then you might see the accidents/deaths happen anyways. Although I think this hasn't caught on enough yet for this to happen in any large numbers, any time something is made illegal there is another way to get it and often it's more dangerous.

I'm not trying to start an argument with you, but I really don't hire my government to protect me from buying nicotine juice and to protect me from my own adult choices. I prefer them to stay the hell out of my life. They have a duty to protect us from foreign (and domestic) enemies, but not from buying nicotine liquid and choosing to inhale its vapor.

Slap on a child-proof cap. Right now, diluted nicotine (e-liquid) is not any more dangerous than any drug or other chemical product that is all ready readily available at Walgreens or CVS.

 

[Legato525]

So, "common sense" is to let any manufacturer of a new drug and drug-delivery device enter the U.S. and sell whatever it pleases? No oversight. No testing. No regulation. No side effects knowledge. No labeling. No warnings. Unknowns galore.

That's your idea of common sense?

No, no, you missed mt point. My point is that if you want to use a product that that has no, or pending safety testing, you can use common sense to make a personal decision on whether or not you feel the product "could" be safe. Obviously if a new drug appeared on the market to make me look like Brad Pitt, but it contained unknown untested chemicals, common sense would tell me not to use it. But in the case of PV's I think I know all the chemicals used (I say I think because I am taking the suppliers word on it.) Then my common sense tells me its probably not more unsafe than cigarettes.

 

[strayling]

So, "common sense" is to let any manufacturer of a new drug and drug-delivery device enter the U.S. and sell whatever it pleases? No oversight. No testing. No regulation. No side effects knowledge. No labeling. No warnings. Unknowns galore.

That's your idea of common sense?

Common sense is recognising when something is being called a "new drug" purely for bureaucratic reasons. Common sense is knowing that if you remove a bunch of known poisons then what's left is likely to be less harmful than the original. Common sense is understanding that in this situation the burden of proof should be on people saying that PVs are more dangerous than the sum of their parts.

I see what you're doing and understand why you want to sound a note of caution, but you're playing a semantic game using legalistic definitions which often have very little to do with common sense. Yes, we have to deal with the legalities, but let's not pretend that a lot of them are any more than a jumping-through-hoops exercise.

 

[Legato525]

Slap on a child-proof cap. Right now, diluted nicotine (e-liquid) is not any more dangerous than any drug or other chemical product that is all ready readily available at Walgreens or CVS.

I agree. Alcohol in its pure form is a poison. OTC Sleeping pills can kill you in high dosages. There are a million government approved products that can kill.

 

[Lithium1330]

Everybody concerned about this FDA issue MUST keep an eye on NJOY, NJOY from the begining of this e-cigarette "revolution" has been making the right steps in every issue, they have been talking with all regulatory agencies involved in their bussines, they have a TSA letter regarding electronic cigarettes, they have importation permissions and since last Jan. Miri Pharma have ivestments in Sottera as pointed out by dc2k08 in this thread: http://www.e-cigarette-forum.com/forum/law-e-cigarette/5708-njoy-walgreens-2.html#post89341 nobody at that time puted much attention on dc2k08 post, but the day when you see NJOY out of bussines you can start to worry about a ban, right now BP has a friend playing this game already, lets wait for BT to make a good friend in the market or release their own products, this technology has a very big potential revenue to just let it die into a ban.

Houlihan Smith Arranges Non-Control Equity Investment Into Sottera, Inc., dba NJOY,... | Reuters