Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Sun Vaporer]

I understand the fda can regulate tobacco. That older finding states in the index that it doesn't matter what similar devices are on the market, how they are constructed, what users use it for , what lower employees say , but what is the manufacturers intent. I have syringes for injecting epoxy into fiber optic cable connectors that could be used by drug addicts though that is not the manufacturers intent. paraphrasing SE "we want them to use our product as long as they used cigarettes' Do you think we have a chance that they will be deemed some form of tobacco product ? Maybe wishful thinking.

TS--It is within the Judge's preview to decide what the intended use is that he is going to apply and what catagory he is going to place the e-cig in. Judge Leon really only has to conclude that the e-cig is in or not in the jusrisdiction of the FDA. That really is the issue here.


Sun

[cityboy]

TS--It is within the Judge's preview to decide what the intended use is that he is going to apply and what catagory he is going to place the e-cig in. Judge Leon really only has to conclude that the e-cig is in or not in the jusrisdiction of the FDA. That really is the issue here.


Sun

Did you mean "is not within .. " ?

[Sun Vaporer]

Did you mean "is not within .. " ?

City--either the FDA has jurisdiction or it does not---it is black or white.


Sun

[LoneRanger]

Did you mean "is not within .. " ?

I was going to ask the same
thought he left out the word- not-

Sun,Judge Leon can decide intended use and catagory to place e cig in?

[lotus14]

City--either the FDA has jurisdiction or it does not---it is black or white.
Sun

Sun--

Now I'm confused.

I thought SE/NJOY were arguing that their products are tobacco products. The new legislation specifically gives the FDA jurisdiction over these products.

The only issue I see that is left is whether the FDA can regulate e-cigs as drug device combos, or must follow the guidelines in the legislation for tobacco products.

Didn't congress give them jurisdiction either way? How can they not have jurisdiction?

[kristin]

Sun--

Now I'm confused.

I thought SE/NJOY were arguing that their products are tobacco products. The new legislation specifically gives the FDA jurisdiction over these products.

The only issue I see that is left is whether the FDA can regulate e-cigs as drug device combos, or must follow the guidelines in the legislation for tobacco products.

Didn't congress give them jurisdiction either way? How can they not have jurisdiction?

If my understanding is correct, if they are ruled a tobacco product, then the FDA cannot ban them outright, they can only regulate them. If it's ruled a medical device, the FDA has even more control.

[lotus14]

If my understanding is correct, if they are ruled a tobacco product, then the FDA cannot ban them outright, they can only regulate them. If it's ruled a medical device, the FDA has even more control.

Yes, that is my understanding also. Either way the FDA has jurisdiction, it's a matter of which guidelines they have to follow.

[Bryn]

If my understanding is correct, if they are ruled a tobacco product, then the FDA cannot ban them outright, they can only regulate them. If it's ruled a medical device, the FDA has even more control.

Yes, this is what I understand. I am wanting the Judge to rule it a tobacco product. Ruling it a medical device would be a very bad news for us. Big Pharma will have a huge celebration.

I think the Judge will do the correct thing. Fingers crossed.

[Tin Cup]

And now the crowd gathers for the 6 o'clock update......

[Sun Vaporer]

If my understanding is correct, if they are ruled a tobacco product, then the FDA cannot ban them outright, they can only regulate them. If it's ruled a medical device, the FDA has even more control.

Kristin--it goes to how intense the approval process would be. Remember that SE and NJOY came up with the "It's a tobacco product" BEFORE the legislature passed the new statute giving the FDA jurisdiction over tobacco products. In the pendency of this case that statute was passed. At that point in time, it was the best argument SE and NJOY had because of the holding in BROWN that held that the FDA has no jurisdiction over tobacco products.


So indeed there are different standards of approval for Drug and Drug devices and tobacco products.

Sun