SE VS FDA Question

[ashdaburned]

With SE claiming that the e-cig is in essence a tobacco product, if they win will that mean that there is to be no more vaping in no smoking areas? If so, isn't there a way to get the liquid without getting it from tobacco, which would then make it a non-tobacco product?

 

[TheIllustratedMan]

See, the thing is that SE and NJOY are claiming that their products are tobacco products, not that electronic cigarettes are. As far as I understand it, this isn't going to be a blanket issue, it's going to be on a case-by-case basis. So let's say that SE wins the case and the judge allows them to sell their product without FDA approval, that doesn't necessarily give Ruyan (for instance) carte blanche to go ahead and sell theirs.
I could be wrong about this, but I think that it's like coming out with a new Tylenol. Let's say that I wanted to start making acetomenophen tablets and selling them in drugstores. I'm pretty sure that, even though the exact same product is already in stores, I would need FDA approval for my specific product. That process would probably be a lot simpler than for some whole new molecule, but I would still have to go through it.
Can someone confirm my understanding?

 

[Sun Vaporer]

See, the thing is that SE and NJOY are claiming that their products are tobacco products, not that electronic cigarettes are. As far as I understand it, this isn't going to be a blanket issue, it's going to be on a case-by-case basis. So let's say that SE wins the case and the judge allows them to sell their product without FDA approval, that doesn't necessarily give Ruyan (for instance) carte blanche to go ahead and sell theirs.
I could be wrong about this, but I think that it's like coming out with a new Tylenol. Let's say that I wanted to start making acetomenophen tablets and selling them in drugstores. I'm pretty sure that, even though the exact same product is already in stores, I would need FDA approval for my specific product. That process would probably be a lot simpler than for some whole new molecule, but I would still have to go through it.
Can someone confirm my understanding?

Let me try to explain this for you. The SE v. FDA case is not about wheather the e-cig is a tobacco product nor is it just about SE or NJOY per se. The issue at bar is whether or not the FDA has excercised its authority granted to them by Congress properly by imposing embargo actions on e-cigs and that the FDA has exceeding its authority in mandating that e-cigs go though the proper application and approval process. What comes out of this case will be binding on any further actions by the FDA---so do not look at SE or NJOY, rather look to what the Court rules with regards to the FDA.

As set forth in the FDA's pleadings, it makes no difference to the FDA whether the e-cig is a "tobacco" product and the FDA further contends that the new legislation passed for tobacco in no way effects the FDA's power to regulate the e-cig.

So this case is not about a "tobacco" product and it is not about any particular Supplier, rather it is about the FDA and it's excercise of its powers.

Sun

 

[TheIllustratedMan]

Correct, but I was under the impression that there's no way it's going to be a blanket thing. It would have to be on a case by case basis, since each brand and model is a different device. So the judge is only ruling on the particular instance of the FDA blocking SE's imports.
Yes, it will set a precedent either way, but even if the judge rules in favor of SE, the FDA can still claim that another company's device is a separate product and block them. This case could pave the way, but it still won't totally open the market.
Is that wrong?

 

[Sun Vaporer]

Correct, but I was under the impression that there's no way it's going to be a blanket thing. It would have to be on a case by case basis, since each brand and model is a different device. So the judge is only ruling on the particular instance of the FDA blocking SE's imports.
Yes, it will set a precedent either way, but even if the judge rules in favor of SE, the FDA can still claim that another company's device is a separate product and block them. This case could pave the way, but it still won't totally open the market.
Is that wrong?

It makes no difference whether there are different makes or models of the e-cig--The Court is going to rule wheather or not the FDA has the authority to make e-cigs in general go though their application and approval process and actually approved before the e-cig can be imported, sold, and marketed. So this case will totally open or close the market due to the fact that the Court will find one way or the other whether or not the FDA exceeded it authorty.

Sun

 

[TheIllustratedMan]

So they ARE lumping all of the devices into one boat. I got some conflicting information on that, leading to my view. Thanks for clearing that up for me.

 

[Vicks Vap-oh-Yeah]

Additionally - I can see this case lumping the liquid and the devise together as 1 unit - inseparable in the eyes of the law.

There will be no allowing sales on the gizmo, and stopping the liquid (or vice/versa) - if the ruling goes to the FDA....they will be listed as an unapproved drug/delivery device combination with the PV's having an "adulterated use," as that drug delivery device - irregardless of it being simply a heating coil and a battery.

But, this thing could also be tied up in the courts for years - when the ruling comes - the entity on the losing side can always appeal the decision, and further muddy the waters..... A perfect example: how long did BT fight for their right to market "light" cigarettes in court? That packaging is just NOW being forced to change its verbiage - that ruling was fought for over a decade, if I recall correctly.

 

[Pieceman]

But, this thing could also be tied up in the courts for years - when the ruling comes - the entity on the losing side can always appeal the decision, and further muddy the waters..... A perfect example: how long did BT fight for their right to market "light" cigarettes in court? That packaging is just NOW being forced to change its verbiage - that ruling was fought for over a decade, if I recall correctly.

You are correct, however, the cigarette companies had millions upon millions of dollars to pump into court and lawyer fees thus delaying the inevitable ruling. The E-Cig companies don't have that kind of money right now to sustain those kind of costs.

 

[ashdaburned]

The way i read the argument from SE is that they are saying that the FDA did not follow procedure set forth by the APA i think it was, and therefore they should not be allowed to keep the product. Much the same way i'm guessing a police officer who does not have a proper warrant confiscating something.

 

[Sun Vaporer]

The way i read the argument from SE is that they are saying that the FDA did not follow procedure set forth by the APA i think it was, and therefore they should not be allowed to keep the product. Much the same way i'm guessing a police officer who does not have a proper warrant confiscating something.

That is the secondary argument to get SE's product back. The main argument advanced is that the FDA does not have jurisdiction over regulating the e-cig. The FDA simply argues that the e-cig needs to go though the formal application and approval process just like any other product within its jurisdiction. See this thread for a full discussion.

http://www.e-cigarette-forum.com/fo...erywhere-v-fda-daily-docket-sheet-update.html

Sun