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

[Khandurian]

Because the product uses strictly nicotine rather than a form of tobacco, approval rests on the FDA

RIGHT THERE! Right there says it all.

As TB & the FDA said, "It is classified as a new drug". Do you not think BT had a big push into getting the FDA to wake up and see this "new drug"? They are already calculating their losses for when the tax increase comes up and people quit smoking all together. Now, they have to worry about another huge loss because someone came up with a new way of delivering the chemical that were all addicted to.

BTs product has been tested, retested, and tested again through out the years, and continues to be tested ( I would guess monthly if not yearly ) and the reports keep coming out worse and worse. Their up to 4k+ worth of chemicals in their product. Of which 18(?) are known to cause cancer!

A new product comes along, the average consumer sees some initial test results and makes their own assumption that "Wow! 8(?) chemicals vs 4000! Gee, it has to be better considering 7 of those chemicals are food safe!"

Now, had these companies submitted this new "mixture" as I like to call it to the FDA and bid their time, I personally don't think we would be going through all this crap were going through now. Then these companies would be enjoying a MASS flood of revenue.

Looks to me like I just might invest in some tobacco seeds and grow my own. I may not feel as good as I do now, but atleast I will still be able to enjoy the pleasure of smoking and not have to worry about added chemicals.

 

[Ramblin]

Sorry, can't let this go:



Because that is not their job! They do not have authority over either tobacco or alcohol. They have authoritiy -- carefully spelled out in detailed law -- over food and drugs.

Yet
google
govtrack.us/congress/billtext.xpd?bill=h111-1256
or
Family Smoking Prevention and Tobacco Control Act

 

[WillPower]

I'll withhold comment on the various "strategies" to subvert the FDA's clear intention, but will say this: There is another agency yet to be heard from -- and it will almost surely be heard from. It's the agency that protects consumers from false claims. It's the FTC.

The FTC in the past has brought massive lawsuits against marketers who make false claims. If the FDA says these are not for quitting smoking and Brand XYZ claims they are on a Web site, get ready for the FTC to say "prove that claim. You advertised it." The FTC isn't sneaky; they just do screen grabs of Web sites and have their proof.

The damages they can demand are in the millions of dollars.

We've been lied to. And that's a fact. Multiple lies. Over and over. Anyone want to support lying to consumers? No? Then the FTC actions will be deserved and just.

Not trying to subvert anything. Two practical issues about implementation of their ban:

FDA needs to specify what they are banning. Any device has the potential to produce nicotine in a vapor form? My humidifer can do that. Looks like a cigarette? Device that does not look like a cig is not covered? It has to do with intended or marketed use.

People should keep in mind, that gum, patch, water were never banned. While NicLite was banned, chemical supply companies were still selling nicotine solution to the public without any restriction.

The FDA person was right.. Literally, device AND e-liquid are illegal. I think device alone or even e-liquid alone WITHOUT the intent, are unenforceable.

 

[Relentless]

From everything I'm reading, it appears that it needs to be tested. The FDA is charged with making sure the things we market as consumable are safe. I suspect they are rather serious about that. I also suspect they get a bit miffed when someone tries to slip past them. The easiest and best way past this is to comply with their demands and get these things tested.
The other thing to think about is it's not far off that Philip Morris or any of the others will see this as a huge opportunity that will allow them to continue in their chosen field while abandoning the bullet proof vests they've been made to wear for the last ten years...
You better bet your last drop that they are making their own models and juices right now.
I also suspect that we the humble folk will still be able to get our supplies from overseas as long as we aren't ordering in bulk and as long as the shipper has the brains to label the package discretely.
I can order prescription drugs of every manner from over seas and they get through customs because it is not labeled in neon what is in the package.
Everyone needs to calm down and follow the road laid out.
This is not the time to start a ruckus with the government... That time will be here soon enough.

 

[Sun Vaporer]

I think device alone or even e-liquid alone WITHOUT the intent, are unenforceable.

WillPower--I can not concur with this statment about e-liquid at all. The Plight of Nicotine Water clearly shows that Nicotine is a drug within the jurisdiction of FDA control. It is a poision that must meet any and all requiste standards and controls that the FDA places on it. Any argument that the FDA can not enforce a ban simply lacks merit ----Sun

See timeline on the plight of Nicotine Water Nicotine Water

 

[Ludo]

Everyone needs to calm down and follow the road laid out.

Exactly! There is no stopping this esmoking movement, it is a people's movement. We have been around for 3 years, you want me to dig up the numerous mails we have received of customers who have at least succeeded in cutting down significantly killer cigarettes? We have achieved so much and we don't even advertise it because we are not allowed!

 

[Sun Vaporer]

Exactly! There is no stopping this esmoking movement, it is a people's movement. We have been around for 3 years, you want me to dig up the numerous mails we have received of customers who have at least succeeded in cutting down significantly killer cigarettes? We have achieved so much and we don't even advertise it because we are not allowed!

There would be no need to have any "movement" if manufactures would have funded and conducted the requiste studies for FDA approval a couple of years ago!!! So tell us Ludo--does Janty plan on ponying up and funding studies or is it still have the "take the money and run" thinking??--No disrespect, but it is the maufactures who are suppose to fund these studies and do the necessary filings. Not consumers who do not have standing to do so for "your" product. So how about Janty and other manufacturers ponying up like they are suppose to rather then just talking the talk--IMO----Sun

 

[TropicalBob]

Ludo, good to see your post here. Actually, I don't want to see your email testimonials. I want the FDA to see what you have. If any makers can get through the hoops, it has to be Janty, Ruyan and NJoy.

Chill is the last thing I think we should do as countries slam regulations on our practice. Like everyone, I want my e-cigs now and tomorrow. And I don't want to buy my supplies under street lights in bad neighborhoods. I want to know how we users can work with you manufacturers to get this approved. Your posts could help us, help you.

I strongly disagree that this can't be stopped by determined government efforts. We don't want to go there.

 

[Ludo]

conducted the requiste studies for FDA approval a couple of years ago!!!

There are no rules!!! We have been asking for rules for 3 years!!! Are you suggesting JANTY is a take the money and run company???? Go read all our posts here and on other forums before stating such a terrible accusation

 

[Ludo]

Bob, you are right!

 

[Faethe]

OK. This is suddenly just major bull****.

 

[Faethe]

Exactly! There is no stopping this esmoking movement, it is a people's movement. We have been around for 3 years, you want me to dig up the numerous mails we have received of customers who have at least succeeded in cutting down significantly killer cigarettes? We have achieved so much and we don't even advertise it because we are not allowed!

I have maybe one or two analogs a week. This is because my pilot doesn't operate reliably in the car (vibration makes the battery do weird things, etc). I smoked for 30 years. I mean, for all intents and purposes, I have quit smoking which i was never able to do before. More than that - vaping is *preferable* to smoking. It's just a much nicer experience. So even if for some reason you want to smoke analogs, it's a diminished experience.

Hey you - My Janty person - get more stuff in stock! I just got a Dura C (JOYE 510) and need some manual batteries. For the car, you know, because ^ about pilot.

And please see if you can sell juice in bigger bottles!!

//end rant

 

[Sun Vaporer]

There are no rules!!! We have been asking for rules for 3 years!!! Are you suggesting JANTY is a take the money and run company???? Go read all our posts here and on other forums before stating such a terrible accusation

Ludo--only the manufactures have standing to make application for the devices and the nicotine cartridges to the FDA for appoval--that is not an accusation--it is a fact. Just like the Nicotine Water case--it is your company that needs make available the requiste studies and submit them to the FDA for approval---that is not an accusation my friend--that is a fact and if the manufactures had started the ball rolling funding the studies a couple of years ago with their profits, we would have something to fight with today. Only Ruyan has stepped up and actually invested in some studies---so no accusations my friend--only facts as we have really do not have much to present that will stand unrefuted when it comes to making an argument that our practice has been proven safe----Sun

 

[Ludo]

We have been through this before... for 3 years we have been asking for regulations but there was no interest from the governments. Finally we got a deal to sell 6mg carts in Italy, 0mg carts in Estland, 16 mg carts in the rest of Europe.

I don't see why the USA would be any different. There will be regulations and that is a good thing I just wish more people would understand that.

@ sun vaporer: pls check the facts: WE HAVE SUBMITTED TESTS!

 

[TropicalBob]

If shown the way and the light, you have some of the most willing followers on earth, your e-smokers, of which I'm one. Passion is present; direction is what we are lacking.

Grass root efforts are being undertaken by some, but most posters here simply vent anger at a situation not of their making. I think fear is understandable, particularly in light of Health Canada's statement yesterday and a pending answer to Sen. Lautenberg's request for an all-out ban on e-smoking. We need to channel that fear or concern into a productive effort.

Any ideas will surely be appreciated.

 

[Sun Vaporer]

We have been through this before... for 3 years we have been asking for regulations but there was no interest from the governments. Finally we got a deal to sell 6mg carts in Italy, 0mg carts in Estland, 16 mg carts in the rest of Europe.

I don't see why the USA would be any different. There will be regulations and that is a good thing I just wish more people would understand that.

@ sun vaporer: pls check the facts: WE HAVE SUBMITTED TESTS!

Ludo--I do check the facts--backwards and fowards. Where are these tests? Why have they not been used to refute claims that the e-cig is not safe? We would like the cite to your studies and tests--is there a link to them or will you post them as I have not seen them and as a matter of fact the only tests that we have scene are the New Zeland Study and the Ruyan Studies by Pony Testing --so how about a cite so we can see these tests. As for thinking the USA would be the same as other Countries---that kind of thinking is just bad management practices if that was the case---------Sun

 

[sdaniels]

I constantly read through out this thread that "Manufactures and Suppliers should pay for the proper FDA studies and supply the proper paperwork and product"... Why?

Who paid for the Marijuana study? Who paid for the ....... study? Even better yet, who paid for the RAPTIVA study? Oh yeah, that's no longer approved because is causes brain damage, but wait... didn't it get approved? Yes, oh wait the study to approve it passed but when people started dropping like flies an independent study found the progressive multifocal leukoencephalopathy (PML) which of course the FDA took credit for.

 

[Ludo]

http://jantyusa.com/LIQ1.jpg

http://jantyusa.com/LIQ2.jpg

http://jantyusa.com/LIQ3.jpg

http://jantyusa.com/LIQ4.jpg

USA/EUROPE?
You still believe in the old "order"? The world is a village and we are it's citizens.

 

[Legato525]

I have posted on another thread regarding some of my efforts. I have multiple calls in to the FDA right now trying to get the proper paperwork for approval. In addition, I have many emails out to different consumer product testing agencies throughout the U.S. I am working on pricing for testing and making sure I get the proper testing done for the FDA application. I am also working on finding government grants to fund the testing. I realized that fighting the FDA does nothing, working with them is how to win the battle. I also received a letter from my congressman that I will post soon. He states that he will help support us, BUT according to the code of federal regulations, the device does qualify as a medical device due to the way the vaporizer operates.

 

[Ludo]

Tx Legato, that is very helpfull