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

[Sun Vaporer]

Once again, FDA spokesperson Rita Challelle speaks and this time clarifies that the device and the Nicotine are in their sights as reported here:

"A seemingly safer smoking option, the "e-cigarette," is illegal to market and sell in the U.S., according to Rita Chappelle, USFDA spokesperson.
"Neither that device nor the vapor it produces has been approved by the Federal Drug Administration, Chappelle said.
"Such products must meet approval through the Federal Cigarette Labeling and Advertising Act, Comprehensive Smokeless tobacco Health Education Act or the FDA. Because the product uses strictly nicotine rather than a form of tobacco, approval rests on the FDA", Chappelle said.
None of the products have been submitted for inspection or approval, she said."
Whether the vapor can be classified as harmless has yet to be determined by the FDA, Chappelle said.

It appears the FDA, has in its sight the device as well as the nicotine. Only time will tell when the FDA will make its move and the scope of that maneuver------- Sun

See Electric cigarette not quite ready for retail | cigarette, nicotine, tobacco - Local News - Gaston Gazette

 

[TropicalBob]

Get ready for a plethora of "they can't ban the device" posts.

Yes, they can. It is designed, patented and advertised all over the Web as a "safer" way to deliver a drug, the nicotine cocktail. That puts it squarely in the FDA's sights as a medical device with one primary purpose.

The device, carts and liquids are all at stake when the ruling comes down.

 

[smokingclam]

Get ready for a plethora of "they can't ban the device" posts.

Yes, they can. It is designed, patented and advertised all over the Web as a "safer" way to deliver a drug, the nicotine cocktail. That puts it squarely in the FDA's sights as a medical device with one primary purpose.

The device, carts and liquids are all at stake when the ruling comes down.

Got to agree with that too. I think it coming real soon too. To much is changing day to day now.

 

[RjG]

Get ready for a plethora of "they can't ban the device" posts...

Oh, c'mon, that never happens ;-)


We have different opinions on the hardware matter - but that's ok, I respect your opinion, and hope that's a two way street...

Really, it makes little difference... if the 'juice gets banned, what will you put in it? That's the more serious bridge ahead.

 

[brandeeashlynn]

we are next. the ban is coming

 

[Storyspinr]

It sounds like "Rita" doesn't have the foggiest idea about the 'device', since her wording implies the device and the nicotine are inseparable rather than acknowledging the device is capable of performing without nicotine. Without the nicotine, how can it fall under their jurisdiction?

 

[Chevron07]

I agree storyspinr. All of the official statements in the last few days (US and Canada) it really sounds like they just saw the kiosks at the mall and really don't understand the product. Most of it uses "device" and "nicotine cartridge" interchangeably. I think they assume the cartridge is the working part of the device and also don't know about ejuice (other than what's inside the cartridge).

 

[Vicks Vap-oh-Yeah]

Suppliers are going to see another rush on juice and parts...

Stockpiling will get kicked up another notch

 

[Sun Vaporer]

It sounds like "Rita" doesn't have the foggiest idea about the 'device', since her wording implies the device and the nicotine are inseparable rather than acknowledging the device is capable of performing without nicotine. Without the nicotine, how can it fall under their jurisdiction?

People--you may say what you like--but please do not underestimate Rita Chappelle--As I have stated in the past, she is the Head spokesperson for the Drug division of the FDA and she gets paid to only talk when she wants to be quoted and she only states what she knows is factual.

She is the 'Voice' of the FDA and it is her, if and when a ban comes, who will make the press statement--Just goggle her name and look at what you find if you do not want to go and do some real research on Ms. Chappelle.

I do not want to see any ban, but at the same time, I am not going to close my eyes on what is going on either when I am reading statements released from the "voice' of the FDA----------Sun

 

[Storyspinr]

Trust me, Sun Vaporer, I never underestimate any anti embedded in the government. I just think legally they would have a hard time banning the device based on only one substance it is capable of vaporizing. Provided, of course, anybody has the money to challenge them legally.....

As has been said often and better by others on this forum, it is up to the manufacturers to get the studies done and get the cartridges/juice legally approved.

I should point out I got my first e cig this week (I tell people it's a "vaporette", lol) and have already about reduced my 2-pack a day habit to one pack, and that was using the zero nicotine carts. I will not give my e cig up without a fight, as pathetic as that fight may be......

 

[JazzFan]

The ban will be coming to any device claiming to be 'safer', 'healthier' or a way to quit smoking. Now we may all believe these things to be true, but the FDA requires 6 years of testing before they will approve any claim of that nature. The smart folks out there that are simply saying this is an alternative to smoking that allows you do do it indoors are in no immediate danger. There will soon be a barrage of false claims lawsuits against any company (*cough* Smoking Everywhere *) that makes these false claims.

We've talked extensively to the FDA... in fact, a rep from the FDA actually wrote the wording that we put on our package for us.

 

[brandeeashlynn]

what is your website jazzfan?

 

[kinabaloo]

I guess it is possible that rather than banning anything they will pursue those who make 'false claims'.

 

[Klausse]

Hey Storyspinr, I call em vaporettes at times too. The FDA though not approved, has allowed at least one US company to register an E-juice , (Johnson Creek Original Smoke Juice)

Could be a president to start off on. Though "THEY" will be looking for something to rally against fast to take the light off the peanut butter, pharma-caused illnesses and other recent issues.

Worst case scenario, we'll have buy the E-cigs in pieces and mix our own juice for awhile. Prohibition didn't stop the booze, just their share of the take.

Realistically they'll probably test it, hide the results, regulate it and then tax it. I don't think they'd pass up another possible revenue stream. Hell maybe Big Tobacco gets to market it and recoup some of their growing losses!

 

[Vicks Vap-oh-Yeah]

The question I can't help but have screaming through my head is:

Will the ban encompass ALL PV vendors? Will it be across the board? Or, will the manufacturers and distributors who have been VERY careful in their wording, packaging, and marketing be ok?

I can't help but think of Ruyan, who has applied for patents in the USA - will their products be banned?

NJoy, who's marketing is carefully worded to avoid any mention of NRT, cessation, etc....

Janty, who seems to be one of the largest, with a presence around the globe?

Will these survive to sell their products in the US while the FDA works at regulation? What I've seen here seems to suggest that might be possible. But the other side of the coin is equally bright and shiny: many distributors out there are selling these with outragous claims....NRT, smoking cessation, help you quit, diet aids to name just a few.

The unscrupulous vendors out there who make the health claims should be spanked down by the FDA, THAT is part of the FDA's authority and their duty to the public. I would fully support that.

Yes, our suppliers have let us down, by not preparing for the FDA. Even I, with my cracked crystal ball, could see that the dragon would awake, and shake off the dirt of indifference eventually. They were not ready, and we will suffer if a total ban takes place.

We do have some - small - support in Washington. We need more. The people on this forum have put some Hurculean effort this last week in contacting their representitives. But what are our vendors doing??? TW is the only one I've heard of that is trying to stay ahead of the storm in analsys and testing of their products. But the tornado is moving faster then even them, I fear, and they are our best example of aquiesence to regulation.

I've been tobacco free for 2 weeks (I know, a pittance compared to others out here) but have zero cravings for analogs - I've always been more addicted to the hand/mouth habit than the nic. I fear going back to analogs! I urge the suppliers to ramp up their efforts to comply with what the FDA is eventually going to demand - product complacency, honest advertising, and stringent safety measures.

Sorry for the wall of text - I'm done whimpering now....

 

[Sun Vaporer]

The ban will be coming to any device claiming to be 'safer', 'healthier' or a way to quit smoking. Now we may all believe these things to be true, but the FDA requires 6 years of testing before they will approve any claim of that nature. The smart folks out there that are simply saying this is an alternative to smoking that allows you do do it indoors are in no immediate danger. There will soon be a barrage of false claims lawsuits against any company (*cough* Smoking Everywhere *) that makes these false claims.

We've talked extensively to the FDA... in fact, a rep from the FDA actually wrote the wording that we put on our package for us.

Jazz --i wish I could agree, but that is simply false--the FDA has stated on the record that these devices are illegal and consitute a new drug--it is the same as the plight of Nicotine Water. The argument that it goes to how it is marketed simply does not hold water anymore. Chappelle cam out swinging stating that these devices are illegal to sell from a saftey standpoint in another interview--Sun

 

[Sprocket]

Just because they ban it doesnt mean you wont be able to get it. Juice and hardware will be just as easy to get as it is now. Might have to wait longer for shipping, but if you want it you will be able to get it.

 

[Sun Vaporer]

Just because they ban it doesnt mean you wont be able to get it. Juice and hardware will be just as easy to get as it is now. Might have to wait longer for shipping, but if you want it you will be able to get it.

Sprocket--Let us know how you deal with Customs once they get their marching orders from the FDA--you can not mislabel them--so what is your plan here as I am missing something?---Sun

 

[brandeeashlynn]

We all might have to accept the fact that a ban might take place. I know we have a few allies on our side but they are not the big boys that the fda wants. We will not be able to order form overseas that will proably be included in the ban. i dont mean to be dismal but that proof is in the pudding. the more i keep hearing these statmments it seems to me the ban is already starting

 

[Sprocket]

Sprocket--Let us know how you deal with Customs once they get their marching orders from the FDA--you can not mislabel them--so what is your plan here as I am missing something?---Sun

They already mislabel them when shipping from China.