Can someone sumarize this?

[Thornak]

I'm interested in the progress of the court case against the FDA, but because everyone posts on that thread, there are currently 518 pages to go through.

Could someone please summarize it all without all the extra posts from everyone.

 

[Thulium]

I can't guarantee the lack of extra posts, but I'll try to summarize:

FDA began seizing shipments from SmokingEverywhere based on the allegation that it is a new unregulated drug and device combination. SmokingEverywhere filed a suit against the FDA, njoy signed on as party to the plaintiff and asked for a preliminary injunction to stop the FDA from seizing their products. Finally, one month ago Judge Leon issued a ruling granting the primary injunction and agreeing that e-cigarettes should not be banned. The FDA has since filed an appeal to the preliminary injunction and the appeal's court has placed a stay on Judge Leon's decision pending a review by the appeal's court.

So where we are right now? Effectively nothing has been changed except that we do have a favorable ruling which means that--contrary to the attitudes shown by some people here, an overall favorable outcome is very much a possibility.

 

[Thornak]

I heard that a study needs to be done but the FDA says the manufacturers have to do it and it will cost a billion dollars. I thought the FDA was responsible for doing these kinds of studies? After all, if they say proof is needed to show its safe, would they also have to show some kind of proof to show its not safe before banning it?

I don't get it..

 

[ChipCurtis]

I heard that a study needs to be done but the FDA says the manufacturers have to do it and it will cost a billion dollars. I thought the FDA was responsible for doing these kinds of studies? After all, if they say proof is needed to show its safe, would they also have to show some kind of proof to show its not safe before banning it?

I don't get it..

No one has to "get it". It's politics.

They have us in a catch 22. Normal protocol is that the manufacturer is responsible for funding the tests. And this has already been done several times in several different countries. However, the problem with e-cigs is the controversy. We're not talking about getting tests done for toothpaste here. Too many institutions (anti-smoking groups, pharmaceutical and tobacco companies, and government tobacco taxation) are being rankled by this new invention, and they don't like it.

So the government has, in effect, the power to sharpen both ends of the blade. It will claim any self-funded tests (such as the New Zealand studies) to be biased, while then telling these same companies that they will have to pay out billions to the FDA or whatever government agency will conduct "unbiased" tests. Either way, government gets the money it wants by covering both ends of potential conflict-of-interest.

FDA has already conducted a test of their own last year, but they only released to the public the parts of the test that sounded off alarms that the e-cig is "dangerous". Their own tests actually prove this not to be the case. So what the FDA is really saying is: "Pay us off and we will skew our test results closer to your business interests".

 

[Thulium]

I heard that a study needs to be done but the FDA says the manufacturers have to do it and it will cost a billion dollars. I thought the FDA was responsible for doing these kinds of studies? After all, if they say proof is needed to show its safe, would they also have to show some kind of proof to show its not safe before banning it?

I don't get it..

There's nothing yet to get. It's overly simplistic to say "a study needs to be done"--a study on what??

Here's what's up: Right now e-cigs are a "gray market". Either they will fall completely into black market territory, or the FDA will be forced to regulate them by some measure (that they haven't determined yet, mind you). The tricky part is that the FDA isn't receiving 80% of their financing from e-cigarette businesses so they are likely to drag their feet and hide behind red herrings and force tiny home-based businesses to jump through very expensive hoops and wait for 8 year long safety studies, ad nauseum...

...Unless and until a major tobacco or pharmaceutical company that is in the FDA's pocket brings an electronic cigarette or similar product to market, the FDA will continue to drag their feet kicking and screaming about antifreeze and "what about the CHILDREN!?!" as long as they possibly can. This is the reason the SmokingEverywhere vs. FDA lawsuit is so very important: It's not a question of whether or not the FDA will be regulating e-cigs, it's a question of whether they'll be regulating them as a drug/device combination product (that they can ban until testing is completed) or if they should be regulating them like a harm reducing tobacco product that can remain on the market while testing is done.

 

[aubergine]

Having wound my weary way through a LOT of these threads, including arguments, tangents, rants, and etc., I do thank you for that succinct summary.

 

[River]

FDA to ecig industry "pay up like phillip morris, r.j. reynolds and pfizer or we shut you down" "NO CHECKS!!!"