AP: FDA Sending Warning Letters

[DC2]

Well if its as simple as changing marketing strategy, and advertising this product as being used for herbal and tobacco use. Whats the big problem?

If it were that simple, there would be no problem.

The current court case is Smoking Everywhere and njoy against the FDA.
The argument by Smoking Everywhere and njoy is that they do not claim their products are for smoking cessation.

The FDA is arguing that the fact that people use them to quit smoking (intended use) makes them smoking cessation products.
And being smoking cessation products, they are drug delivery devices.

Nothing in these letters shows any reversal of their stance that electronic cigarettes are drug delivery devices.
In fact, these letters not only reiterate their position, but also show they are taking further action than simply seizing shipments.

 

[cozzicon]

If it were that simple, there would be no problem.

The current court case is Smoking Everywhere and NJoy against the FDA.
The argument by Smoking Everywhere and NJoy is that they do not claim their products are for smoking cessation.

The FDA is arguing that the fact that people use them to quit smoking (intended use) makes them smoking cessation products.
And being smoking cessation products, they are drug delivery devices.

Nothing in these letters shows any reversal of their stance that electronic cigarettes are drug delivery devices.
In fact, these letters not only reiterate their position, but also show they are taking further action than simply seizing shipments.

Is it possible that because the FDA is taking steps like this they do not believe they have a good case in the NJoy case?

My bet is that the FDA never believed anyone would stand up to them in court. They got resistance... so they go another route.

That's my read of it.

 

[Poppa D]

DC2,

Again we the people who are consumers have few tools to curve this other than petitions and emails.

The businesses which are invested have a lot to lose, should be searching out greater tools than we have.

 

[KDK]

I think we all need to band together and sue the FDA for oversteping their authority. They haven't gotten any ruling yet , in fact they were already told they could not just declare PVs "drug delivery devices". They were told that they could regulate them as tobacco products. So what are they doing, and why are they getting away with it? Until and unless they are given the authority to declare them "drug delivery devices", how do they get to do anything about them, as they declined to regulate them as tobacco products? And even if they do get them classified as drug delivery devices, the drug delivered (nicotine) is not illegal, and is available everywhere. You can get caffiene in a cup of coffee or in a pill, and I don't hear any complaints about that. The FDA is no longer doing its job for the public, and needs to either change a great deal, or get gone.

 

[JerryRM]

The FDA needs a good cleaning out, a complete overhaul. The problem is, the people who can do that are too busy collecting their own "campaign contributions" and fighting with each other. We the people are at the complete mercy of this organization, known as the FDA.

 

[t9c]

BT>FDA<BP

People

 

[JerryRM]

BT>FDA<BP

People

Yup, no surprise there.

 

[piratecaptainbob]

"We are interested in finding out whether e-cigarettes can be proven safe and effective," FDA compliance lawyer Michael Levy said in a conference call."

i agree this looks good but after reading it a few times notice they dont say "we are hoping these can be proven safe and effective and if they are we will support them" they are "interested" which means if they are proven to be too effective then they will be regulated down to be just as ineffective as the patch and gum and lozenge etc. and if they are proven to be too safe then they will be regulated down to have additives added to the juice which yields multiple harmful side effects such as ........ and suicidal thoughts.

 

[DC2]

Is it possible that because the FDA is taking steps like this they do not believe they have a good case in the NJoy case?

My bet is that the FDA never believed anyone would stand up to them in court. They got resistance... so they go another route.

That's my read of it.

That is certainly one way to read it.
But it can be read exactly the opposite way as well.

History points to the FDA not giving up until someone clamps handcuffs on them.
And the court case, which is where those handcuffs reside, has not been settled yet.

So if there is any hope, it is that they got a read on how the appeal might go.
And hopefully, it is going to go against them.

But that is not how I read these developments.
But that's just me.

DC2,

Again we the people who are consumers have few tools to curve this other than petitions and emails.

The businesses which are invested have a lot to lose, should be searching out greater tools than we have.

We the people who have a lot to lose have been fighting for well over a year.

We have petitions, and Vapefests, and what not.
We formed a non-profit organization named CASAA to represent us.

And if you don't even know what CASAA is, you are not only late to the party, you aren't even attending yet.

A small handful have been diligent in commenting whenever a negative article comes out.
And an even smaller handfull have been showing up in person to help defeat statewide ban attempts.

There are a number of us doing whatever we can.
And there are far too many of us thinking everything is just gonna turn out peachy-keen.

I think we all need to band together and sue the FDA for oversteping their authority.

You can't sue the FDA.

 

[Poppa D]

We the people who have a lot to lose have been fighting for well over a year.

We have petitions, and Vapefests, and what not.
We formed a non-profit organization named CASAA to represent us.

A small handful have been diligent in commenting whenever a negative article comes out.
And an even smaller handfull have been showing up in person to help defeat statewide ban attempts.

There are a number of us doing whatever we can.
And there are far too many of us thinking everything is just gonna turn out peachy-keen.

I thank you for pointing that out DC2, and to all those who had the initiative and knowledge to organize so many.
I speak for my self alone when I say I hope that my one lone voice carrys further when joined by those whose passions are similar to mine.

 

[Mar]

I didn't see anyone else post this in the thread, I posted it in another thread but anyways this is a link to a copy of the letter for anyone who wants to read it.

Johnson Creek Enterprises, LLC 9/8/10

Edit: specifically the letter to Johnson Creek

 

[PoliticallyIncorrect]

My bet is that the FDA never believed anyone would stand up to them in court. They got resistance... so they go another route.

That's my read of it.

Perhaps I'm being optimistic--pollyannish, if you prefer--because I want to. I don't sleep well at night and I'm unhappy as a general matter when I'm ...... off. But there's one passage in the article I've not seen anywhere before:

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials."

The operative phrase in my delusion is "work with." Unless it's blather--that's certainly possible--it could indicate a recognition by the FDA of the diminishing returns to be expected for ever greater resources expended in attempting an outright ban. Perhaps, just perhaps, they've lowered their sights.

 

[cozzicon]

I didn't see anyone else post this in the thread, I posted it in another thread but anyways this is a link to a copy of the letter for anyone who wants to read it.

Johnson Creek Enterprises, LLC 9/8/10

Edit: specifically the letter to Johnson Creek

Exactly what I surmised about the gist of the letter. The testimonials are illegal (apparently). And there is one section actually made by JC which might be construed as questionable.

However, someone should sue based on freedom of speech, considering most statements while published by JC were not *made* by JC.

 

[535cheetah]

ya here is msn's article on the subject they just posted online....

FDA Sends Warning to E-Cigarette Distributors - MSN Health & Fitness - Addiction|Quit Smoking

what a buncha crap!

 

[KDK]

I don't know why we can't sue the FDA- everone is sueing everbody for everything! But if we can't, there has to be something that can be done. This is OUR government, and therefor, OUR government agency! They are doing a horrible job, and as taxpayers, we should have some right, and some way to hold them accountable. If not, why are we expected to pay taxes? Well, if they try to make vaping illegal, they are going to drive it onto the black market and won't be collecting any tax for it anyway I guess. But it shouldn't be like this. Sorry, I guess I'm just an idealist.

 

[iamjn]

I didn't see anyone else post this in the thread, I posted it in another thread but anyways this is a link to a copy of the letter for anyone who wants to read it.

Johnson Creek Enterprises, LLC 9/8/10

Edit: specifically the letter to Johnson Creek

Thanks for the link. The rest of the letters can be found here: Electronic Cigarettes

In reading through the FDA letter to Johnson Creek, in my non-legal, not so humble opinion, they are really reaching here. Most of their points of reference are to comments that users have left on their site, which I'm sure that JCE has a disclaimer about not being responsible for the contents of. The few JCE direct quotes that the FDA points out are still stretches to say they violate the laws that are cited. No place that I could find in the examples given does JCE make claims. They simply state opinions, reports by users, and reports on actual experience. IF JCE was saying "use c-cigs to quit smoking" or "nicotine is not dangerous", then the FDA would have ground to stand on. As it is, I don't think they do (not that my opinion matters much to them, JCE, or any judge).

The other thing I picked out was that the FDA is complaining that JCE doesn't have clear directions on the intended use of their e-liquid. I'm riding the fence kinda on that one. It would be easy enough for JCE to put up a statement that the liquid is used for vaping in e-cigarettes only (maybe they already do-I'm not actually a JCE customer, and didn't check). On the other hand, why should they have to do so until the FDA gets a ruling that e-cigs are a drug delivery device? Coke and Pepsi don't have to put disclaimers on their cans that soda is intended for consumption only and not for loosening rusty bolts, so JCE shouldn't have to put an intended use on their stuff either.

The upside here is that they are mostly sticking with their original argument that they are going to court about in a few weeks. The downside is that based on the fda.gov front page and list of recent articles about e-cigs from them, they are gearing up to dig their heels in and put up a fight. Which is another reason that people need to speak up to whoever (both in power and civilians) will listen.

 

[cozzicon]

Perhaps I'm being optimistic--pollyannish, if you prefer--because I want to. I don't sleep well at night and I'm unhappy as a general matter when I'm ...... off. But there's one passage in the article I've not seen anywhere before:

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials."

The operative phrase in my delusion is "work with." Unless it's blather--that's certainly possible--it could indicate a recognition by the FDA of the diminishing returns to be expected for ever greater resources expended in attempting an outright ban. Perhaps, just perhaps, they've lowered their sights.

Well, my take on it comes from a little experience in business.

It's going to be a negotiation, in and out of court. Pressure will need to be applied in the courts, in the press, and at the grass roots.

Somehow the FDA will be involved. Hopefully it is in areas that are helpful to the consumer- quality control. More than that is undesirable.

We have to see what the court does. The "medical claims" as put forth in the letter do seem to at least be reasonable- in that they could be construed in that manner.

But the genie is already out of the bottle. It's going to be hard to put it back in. No one wants two million angry ex smokers in the USA. That's a voting block.

Lots of variables... but outright ban? No loopholes? No access? Ain't gonna happen.

 

[DC2]

But there's one passage in the article I've not seen anywhere before:

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials."

The operative phrase in my delusion is "work with." Unless it's blather--that's certainly possible--it could indicate a recognition by the FDA of the diminishing returns to be expected for ever greater resources expended in attempting an outright ban. Perhaps, just perhaps, they've lowered their sights.

That is something one would like to hang their hat on for sure.

But the FDA has unlimited resources, paid for by you and me.
And they love spending resources, and don't care about using more resources (money) to get what they want.

Paid for by you and me.

But yeah, it could very well be that there is a limitation to their resources.
And if so, then they might be backing off a bit.
That is certainly something to hope for.

But if you read the words, it says "to help people quit smoking cigarettes" and that is the crux of the problem here.
That means they are drug delivery devices.

And therein do we lose.
And everyone really needs to understand this.

 

[PoliticallyIncorrect]

...but outright ban? No loopholes? No access? Ain't gonna happen.

I agree. If only because the word prohibition carries the taint of phrases like McCarthyism, or New Formula Coke. What is possible--or what I fear is possible--is what, frankly, got me here to begin with: the de facto prohibition on cigarettes by means of prohibitive taxation.

 

[5cardstud]

No wonder I get so horny when I vape.