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

[Sun Vaporer]

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.

SDaniles--the issue in the US is that noone but the actual manufacturer has standing to make application to the FDA along with the requiste studies and clinical trials on saftey. We, as consumers lack standing to take these actions on behalf of the manufactures to make application for them.-----Sun

 

[WillPower]

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

Yes. FDA has jurisdiction over nicotine except tabacco. I was referring to what their "ban" means, not subverting, but interpreting their exact FDA intent that must be within the specific legistrative intent of the Congress.

Take the case of nicotine water. While they were banned. People could buy nicotine suspended in pharmaceutical grade water in low concentration from chemical suppliers. Take gold or lead. If you put gold or lead powder into water and drink it, you get heavy-metal poisoning. Gold or lead is not "banned."

Also, what "control" means is another issue. Rat poison is a poison, but it is sold over the counter--just need clear label, etc.

So, the question is: is FDA banning e-cig or personal vaporizer? The real answer will come from the specific language used in the FDA "ban," if there is going to be one.

But, I see some vendors are moving toward describing their products as personal vaporizer.. Very smart move, I think. There are a number of other devices in the "personal vaporizer" or nebulizer category that have rarely or never been used to inhale nicotine.

 

[markab]

Hi Ludo,
In all fairness it's rather hard to believe that you thought that there were no rules governing the manufacture and distribution of new products (which includes e-cigarettes). It seems pretty clear to me -and I'm no business major, that if I wanted to manufacture and sell a new product that vaporizes a chemical solution that is designed to be inhaled and absorbed through the lungs that governing bodies may have a thing or two to say about it.

Three years ago did you contact the FDA or Health Canada and say "Hey, we've developed this great new product. Here is how it works, here is what it contains. What do we need to do to market it to people in your country?" If you had, undoubtedly you would have been told what testing procedures were required.

Now I'm not singling you out here as other manufacturers/suppliers are also guilty of not playing by the rules, but frankly, your among them.

Mark

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

 

[Sun Vaporer]

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

Ludo--these are not peer reviewed clinical trials that the FDA mandates for a new drug classifcation and approval---we can not do them and the FDA mandates them--so is your company going to do them because that is where we are headed and these studies are very time conusming and costly---Sun

 

[TropicalBob]

That's great work, Legato. A year ago, the FDA did not know what an electronic cigarette was. It's hard to qualify a device they don't even know about. I called them a year ago for comment on a story I wrote for SmokeShop magazine. They didn't know what I was talking about!

Now they know. Do things right this time and you might be among the first to get a specific approval. And, yes, approvals must be made for each maker and each liquid producer. There won't be blanket approval -- but there can be a blanket ban.

Keep up the good work. And thanks for your posts, Ludo.

 

[Ludo]

Yes we did Mark and we got no answer back! So we did tests in Italy and in Germany and we checked Ruan's tests and all came out safe and as everyone knows there are no issues.

 

[Ludo]

Sun Vaporer, you are a specialist? let us know!

K, going to bed now, haven't slept for the past 3 days.

 

[Sun Vaporer]

Hi Ludo,
In all fairness it's rather hard to believe that you thought that there were no rules governing the manufacture and distribution of new products (which includes e-cigarettes). It seems pretty clear to me -and I'm no business major, that if I wanted to manufacture and sell a new product that vaporizes a chemical solution that is designed to be inhaled and absorbed through the lungs that governing bodies may have a thing or two to say about it.

Three years ago did you contact the FDA or Health Canada and say "Hey, we've developed this great new product. Here is how it works, here is what it contains. What do we need to do to market it to people in your country?" If you had, undoubtedly you would have been told what testing procedures were required.

Now I'm not singling you out here as other manufacturers/suppliers are also guilty of not playing by the rules, but frankly, your among them.

Mark

Quite true Mark--and the FDA has no concern about learning about a new product that someone wants to market. If a manufacture wants to peddle a product on the up and up --it is their burden to make an application to the FDA and go through the requisite approval process conducting peer group clinic trails and saftey studies. So do not try to shift the burden that the FDA did not know about the product--that is not what their function is. It is up the the manufacture do apprise and take the necessary steps---So do not put a twist on it. We, as consumers are in this position today becasue of the lack of responiblitly of the manufactures plain and simple---Sun

 

[Legato525]

See the trick is to read all of the comments released by the FDA. I spent a couple hours the other night and I noticed a pattern. The FDA is not trying to ban them to be malicious. they are doing it because this business boomed in the U.S. without the proper channels being notified. The next thing I noticed is that they are not against PV's, their against the way they are being marketed. In my calls to them I have requested what kind of documentation is needed to market, if I did not market them as "Healthy", "Safe",Smoking Cessation product", or a "Nicotine Replacement product" These are the terms that they are upset about. They are upset because the suppliers are marketing them by making statements that "DO" require an FDA seal of approval. If from the start PV's were marketed as nothing more than a novelty item. We might not be where we are today. But hindsight is 20/20. All we can do now is start the responsible path. By the way, I am not a supplier or manufacturer. I am just a passionate consumer who will do what ever it takes for me to continue my hobby. I am going to represent a specific brand in my research, but I will make it all known when I find out so that other suppliers will know what to do.

 

[TropicalBob]

Here's the first thing a company intending to market a product as potentially controversial as e-cigarettes should do: Hire a lawyer.

That's just common sense. Hire a lawyer to investigate the legalities and pitfalls involving your product. The lawyer would have found and spelled out the steps a company introducing a new drug to America must take. This one is truly a no-brainer.

Why would any company willy-nilly put an inhalation drug-device product on sale before testing and approvals?

 

[CandyGirl]

Why would any company willy-nilly put an inhalation drug-device product on sale before testing and approvals?

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

 

[TropicalBob]

Got that right!

But "novelty" item is the way I think the future of e-smoking must go. It was stupid to make unsupported health claims. It was stupid to call these e-cigarettes. It was stupid to produce them to look exactly like a cigarette, cigar or pipe. Water over the dam. Mistakes made. Time to shift gears.

I want my e-cocktail to sit beside my laptop, and I want it now!

 

[Faethe]

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, can you let us see them or do they contain trade secrets?

 

[Faethe]

Yes we did Mark and we got no answer back! So we did tests in Italy and in Germany and we checked Ruan's tests and all came out safe and as everyone knows there are no issues.

Again, Mr. Ludo - if you post the results here, we can all help you shift them around as we have with the Ruyan study.

Besides, everyone likes your product better than Ruyan

Have a good sleep

 

[VapeAllDay]

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.

 

[TropicalBob]

The future?

 

[Sun Vaporer]

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

Exactly Candy--instead of investing in this product, the manufactures choice to take the "greed" route here and pocket the money and run instead of doing the responisble think of spending money, like TB stated---hire Counsel, make application, and do the studies. The backward approch that the manufactures choose to take has left all of us as conusmers up a creek with out a paddle. This is not an issue that Conusmers or Suppiers can address as only the manufacturer even has the right to make a filing with the FDA.

Now we are stuck in a jam and there is not much we can do but to load up while we can. That IMO is a bad position to be put a conusmer in----Sun

 

[Legato525]

Got that right!

But "novelty" item is the way I think the future of e-smoking must go. It was stupid to make unsupported health claims. It was stupid to call these e-cigarettes. It was stupid to produce them to look exactly like a cigarette, cigar or pipe. Water over the dam. Mistakes made. Time to shift gears.

I want my e-cocktail to sit beside my laptop, and I want it now!

LOL, so true. I understand from a sales person point of view that marketing them as healthy can make huge profit potential. The weird thing, is why has NJOY or Smoking Everywhere not funded any type of testing. They are huge nation wide resellers. You would think that such big companies would have started research already.

 

[Ramblin]

Why would any company willy-nilly put an inhalation drug-device product on sale before testing and approvals?

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

 

[Legato525]

Now we are stuck in a jam and there is not much we can do but to load up while we can. That IMO is a bad position to be put a conusmer in----Sun

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.