FDA FDA response to lawsuits.

[bigdancehawk]

I'm not a Lawyer. But if the Plaintiffs motion for Summary Judgment is Fully Granted, didn't we Win?

Yes, we win at district court level. However, the case will then be appealed to and decided by the circuit court of appeals and, if the Supreme Court thinks it's worthy of consideration, it will then go there.

 

[bigdancehawk]

All I want to hear from the judge is, "Plantiffs request is granted, we will reconvene for opening arguments on..."

There will be no trial. Summary judgment eliminates the need for a trial. Most of these kinds of cases are disposed of on summary judgment and this one will be no exception.

 

[bigdancehawk]

I hadn't heard this before, that they aren't going to step on spare parts and coils and so forth. They may just be blowing smoke. I don't know where the definition of "finished tobacco products" comes from. Does battery just mean an 18650, or would it include a Spinner. Or a battery holder of whatever type. You can build an entire Kayfun from spare parts. The coil part could be a sliver of good news, if they aren't lying about it for the purpose of the court case. There are enough Nautilus tanks out there already to make it worth the while of the Chinese to make and sell coils for a long time.

They say "the FDA plans to enforce....". Is this plan written down somewhere? Presumably they could change their plan whenever they choose.

Moreover, there is reason to doubt Nicopure’s hyperbolic calculations about the effects of the rule on its own business, which are based on the faulty assumption that it will submit premarket applications for every item in its internal stockroom—including batteries, heating coils, and replacement parts—even though the FDA plans to enforce the premarket application requirement only with respect to “finished tobacco products,” such as “e-cigarettes, or e-liquids sold separately to consumers,” id. at 29,019.15

They are using weasel words like "internal stockroom," "such as" and their definition of "finished tobacco product." If it doesn't require further manufacturing before it's packaged and sold to consumers, it can be treated as a finished tobacco product, whether it contains nicotine or not, and it can't be legally sold without an approved PMTA. It's the height of arrogance for the FDA to make non-binding statements like, "We're not planning to do such-and-such right away, so you can't complain about it yet. After this wildly expensive litigation is concluded, we'll do what we want and if you don't like it you can start another wildly expensive lawsuit."

 

[bigdancehawk]

I believe it started with mandatory bicycle helmets.
But it may have started way before that.

At the state level, I think motorcycle helmets were earlier. I'm not sure what the first federal "you will do [or not do] such-and-such even though it has no effect on the health or safety of others" was.

 

[VapNMirrors]

Nicotine base sold to someone creating eliquid for sale?
Not a finished tobacco product.
PMTA rests on the shoulders of the eliquid seller.

So if I DIY juice for myself then I am a manufacturer but if I never release my product to market then there's no PMTA as there is no seller. Kapow FDA!

 

[bigdancehawk]

No, regulatory agencies are designed to avoid that whole silly mess.

It may even have been a good idea once upon a time, had it not become corrupt.
But then again, that is the nature of all governments, so it was inevitable that it become corrupt.

So yeah, no, it was never a good idea.

Separation of powers is a bedrock principle of this republic. Yet congress has routinely given administrative agencies the power to legislate and the agencies have been more than happy to do so. This deeming is a perfect example.

The notion that congress could or would delegate the power to legislate to unelected officials in the administrative branch of government was utterly abhorrent to the Founders. They took great pains to preclude it and they never thought it would happen under the constitution they wrote. But congress has done it anyway and both the administration and the courts have gone along.

 

[rwoodin]

Tobacco Helmets. It's gonna happen.

 

[DC2]

Separation of powers is a bedrock principle of this republic. Yet congress has routinely given administrative agencies the power to legislate and the agencies have been more than happy to do so. This deeming is a perfect example.

The notion that congress could or would delegate the power to legislate to unelected officials in the administrative branch of government was utterly abhorrent to the Founders. They took great pains to preclude it and they never thought it would happen under the constitution they wrote. But congress has done it anyway and both the administration and the courts have gone along.

This is really the entire crux of the matter.
And what so many people just don't understand, or care to understand.

It's the kind of thing that not only has to be stopped, it has to be REVERSED.
And it starts and ends with the Supreme Court.

 

[zoiDman]

Yes, we win at district court level. However, the case will then be appealed to and decided by the circuit court of appeals and, if the Supreme Court thinks it's worthy of consideration, it will then go there.

I can't imagine this Not going to the Appellate Court. My Hope though is that when it does, that we at Least have a Partial Judgment on Our Side.

 

[skoony]

They do acknowledge they apply pharmecutical standards to ecig products.

Bingo! You are the 1,333,582'thousand winner and new owner of the innerwebs.

I have said time and time again and, for the sake of argument I will say
it one more time.

At this time and from what we know there isn't any reason to make something as easy and safe to
make and, as easy and safe to use as e-liquid as any other consumer product and regulate it as a
pharmaceutical product.

NOBODY is putting the mineral oil they cleaned their paint brush's with into the juice.
For crying out loud not one reported case of harm from so called juice that "someone"
put any old thing in there and caused harm.Not one.(do not mention where some have added their
preferred crap after the fact)
The real reason for all of this is before everyhting is said and done is this one interesting factoid.
When I smoked 2 packs a day at $15.00 a day and quit and now consume about
$0.40 of juice at the local retail cost is evidently making a lot of people mad.
Do the math.

It's not rocket science regards,
Mike

 

[bigdancehawk]

This is really the entire crux of the matter.
And what so many people just don't understand, or care to understand.

It's the kind of thing that not only has to be stopped, it has to be REVERSED.
And it starts and ends with the Supreme Court.

Well, people had better start paying attention. It may be too late. We are already largely a nation governed by unelected bureaucrats. The courts have traditionally "deferred" to their decisions by rationalizing that they are "experts." This is, of course, nonsense. Mitch Zeller is a lawyer with no scientific or medical credentials.

‘‘The accumulation of all powers, legislative, executive, and judiciary, in the same hands, whether of one, a few, or many, and whether hereditary, self-appointed, or elective, may justly be pronounced the very definition of tyranny.’’ James Madison

 

[TheMike21]

I can't imagine this Not going to the Appellate Court. My Hope though is that when it does, that we at Least have a Partial Judgment on Our Side.

What ever the outcome is it will be appealed.

 

[zoiDman]

Well, people had better start paying attention. It may be too late. We are already largely a nation governed by unelected bureaucrats. The courts have traditionally "deferred" to their decisions by rationalizing that they are "experts." This is, of course, nonsense. Mitch Zeller is a lawyer with no scientific or medical credentials.

...

I agree that People need to pay More Attention. But I Also think that their scrutiny of what is Going On needs to be aimed Higher.

Did Mitch Zeller have the Final say as to what the FDA's Deeming of e-Cigarettes looked like?
If Not, who at the FDA is Ultimately Responsible for FDA Policies.
And does the FDA answer Directly to any Other Government Agency?

I see Mr. Zeller's name in media a Lot when it comes to e-Cigarettes. But the name Califf is seldom mentioned. And the name Burwell is virtually Non-Existent.

 

[zoiDman]

What ever the outcome is it will be appealed.

Yeah... That is Kinda how our System works.

 

[kross8]

I'm just incredulous over the fact that on the very first page they instruct the court not to bother looking through the scientific evidence because they (the FDA) are the experts.

and now we know the mindset of the FDA,, wanna bet they released drugs to kill us via cancers/conditions etc

 

[mostlyclassics]

I'm no lawyer, but I look at the FDA Deeming Regulations as but one more horror perpetrated by the Administrative Procedures Act (1946), which ended separation of powers between the Legislative and Executive branches in this country. In effect, Congress delegated the making of laws to the alphabet-soup agencies of the Executive branch. We are not the only group to get gored on its horns, not by any means.

And now, 70 years later, administrative law is so firmly entrenched in our system of government that I doubt it will ever be repealed. Besides, a lazy and all-too-politicized Congress likes it too much: "Here's a rough outline, alphabet-soup agency. Figure out what we mean and make laws."

Sickening. The Founding Fathers are twirling in their graves.

 

[Racehorse]

How did our country come to this lowly state of operation?!

I already gave my opinion on that but I will give it again.

It's because the tobacco industry lied to everybody for decades, and now there is extraordinary oversight and caution because nobody wants to be "taken" again.

You can't bring a new product or technology to market now and just give word "assurance" that "our stuff is totally safe!" ...... because that's not how things have turned out (not only with cigs but with supplements, drugs, etc.)

(Don't even get me started on "assurances" from corporations and oil companies like BP and the The Deepwater Horizon disaster.......I have a friend who's family member died that day......it still will cost BP less than the cost of providing proper and regular maintenance ..... a life lost is cheaper than actually doing the right and honest thing........)

 

[Racehorse]

and now we know the mindset of the FDA,, wanna bet they released drugs to kill us via cancers/conditions etc

No, I think you have it wrong.

The ones doing that are Dow chemical, Big Tobacco, Big Food Industry, Monsanto, Big Oil, etc.

 

[kross8]

No, I think you have it wrong.

The ones doing that are Dow chemical, Big Tobacco, Big Food Industry, Monsanto, Big Oil, etc.

i agree BT,BP, and all of the others you listed are willing to kill us with whatever,,,, i believe the fda is no different and a party to those killings knowingly.

 

[seminolewind]

The only thing reasonably related to tobacco is nicotine. Isn't nicotine grandfathered in? So aside from nicotine, how can anything else be deemed illegal? Is inhaling vick's vaporrub illegal?

Follow the money