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

[Sun Vaporer]

True, which is ridiculous. If these things are safe, then what's the issue? They don't have an argument against e smoking. They can only link e smoking to real smoking for so long.

Besides, if they really gave a sh.it, they would be behind e smoking.

Giantfan--You just made the FDA's Case when you wrote above "If these thinks are safe . . ." We think they are safe and they more then likely are, but until some real studies are done besides the New Zeland, that are down within the four corners of the FDA, we really do not have a very strong argument to cite to against the FDA's positon.


Sun

[Our House]

Giantfan--You just made the FDA's Case when you wrote above "If these thinks are safe . . ." We think they are safe and they more then likely are, but until some real studies are done besides the New Zeland, that are down within the four corners of the FDA, we really do not have a very strong argument to cite to against the FDA's positon.


Sun

Meh.

The face of the FDA is saying "show us the studies." But the real FDA is doing something different. The REAL FDA has already taken the standpoint that these things cannot meet the approval process no matter what. LegalOne has shown that in the FDA emails SE received. It's also evident in the FDA's actions everywhere you go. The FDA has declared "all in" in this case, is unwilling to compromise, and has already publicly announced that it will appeal an unfavorable decision.

Other ecig companies who have submitted applications for approval "are getting the run-around" as you posted earlier in this thread. And of course, the FDA has its own study which was doctored up and press-released to condemn the safety of ecigs to eternal damnation, but held back for months for some reason in spite of the "dangers these products pose."

Now, I have to ask: If you were an ecig manufacturer with $200,000 worth of studies on the safety of your product, would YOU release them to the FDA before you were told what license you were applying for and if you could even get it?

[Sun Vaporer]

Meh.

The face of the FDA is saying "show us the studies." But the real FDA is doing something different. The REAL FDA has already taken the standpoint that these things cannot meet the approval process no matter what. LegalOne has shown that in the FDA emails SE received. It's also evident in the FDA's actions everywhere you go. The FDA has declared "all in" in this case, is unwilling to compromise, and has already publicly announced that it will appeal an unfavorable decision.

Other ecig companies who have submitted applications for approval "are getting the run-around" as you posted earlier in this thread. And of course, the FDA has its own study which was doctored up and press-released to condemn the safety of ecigs to eternal damnation, but held back for months for some reason in spite of the "dangers these products pose."

Now, I have to ask: If you were an ecig manufacturer with $200,000 worth of studies on the safety of your product, would YOU release them to the FDA before you were told what license you were applying for and if you could even get it?

Our House--I do not really care about the FDA--what I would look at is a very strong case against the FDA if the studies were done and could not be refuted, thereby allowing Counsel to show the Court that the FDA is acting arbitrarily and capriciously and obtain a ruling overturning the FDA's abuse of discretion. Spending $200,000 for many large corporations on projects that may never come to fruition is done all the time and is really a drop in the bucket.

Sun

[Our House]

what I would look at is a very strong case against the FDA if the studies were done and could not be refuted, thereby allowing Counsel to show the Court that the FDA is acting arbitrarily and capriciously and obtain a ruling overturning the FDA's abuse of discretion.

Wait, I just realized something.

Are you saying that there's an aspect to the heath/safety of ecigs that could actually have some bearing on this case? Because I was under the impression that this case had absolutely nothing to do with the health/safety aspect of ecigs.

[Giantfan]

Giantfan--You just made the FDA's Case when you wrote above "If these thinks are safe . . ." We think they are safe and they more then likely are, but until some real studies are done besides the New Zeland, that are down within the four corners of the FDA, we really do not have a very strong argument to cite to against the FDA's positon.


Sun

This doesn't appear to be as a big of a problem as you are making, even though convincing studies would help right now.

Of course, the e cig world should have prepared for this, but they didn't, however they might be preparing or could prepare. Then there might be an interesting question: what if there are legitimate studies done that show e smoking is indeed safe?

What will the FDA do? They could try the same tactics they've used so far, but how long could that last before the truth us exposed to everyone?

Will they back off then?

If e cigarettes are safe, and the evidence comes out, the FDA, with pressure, will have to back off.

Just because we don't have the answer to our question right now, doesn't mean the whole thing is screwed.

You know damn well that even if e cigs are determined to be safe, the FDA will still be against. But, they can only go so far if that is the case, I would hope.

[Sun Vaporer]

Wait, I just realized something.

Are you saying that there's an aspect to the heath/safety of ecigs that could actually have some bearing on this case? Because I was under the impression that this case had absolutely nothing to do with the health/safety aspect of ecigs.

Although this case is indeed on of Jurisdiction, If health and safety are not mentioned in the ruling, I would be shocked.


Sun

[Sun Vaporer]

Sun

[Sun Vaporer]

Well, it looks like the FDA does in fact regulate tampons---toothbrushes I did not find.


See Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)


Sun

[Sun Vaporer]

Well --they the FDA does appear to be calling the Electric Toothbrush a medical device but I do not see where it requires approval--apprear the FDA only reports on recalls.

See Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills


Sun

[JerryRM]

Did the FDA overstep when they blocked imports? Yes. Do their pleadings suggest an inflexibility and intolerance of the public health benefits of e-cigs? Yes. Should the judge restrict their actions to those now compelled by the new tobacco control act? Yes. But, again, I assert- this is now about turf . . . and health and safety are secondary.

So, instead of doing their job of protecting "we the people", they are acting more like a street gang, protecting their territory and we are caught in the middle of the battle!