Deeming Regulations have been released!!!!

[DavidOck]

From that:

defendants’ memorandum must explain to the Court: what is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule

I wonder if the FuDA even knows...

 

[Eskie]

Huh, so she still has questions after those oral arguments, with a pretty pointed issue regarding nicotine free liquids being regulated. Now if only the question included hardware to be used with, or intended to be used with a nicotine ejuice could also be considered a tobacco product. Making juice is no issue for me, but I'd like to still be able to obtain vape gear as well.

She didn't give them much time to prepare those filings, either. I guess both sides won't be enjoying Halloween this year.

 

[Robino1]

I guess both sides won't be enjoying Halloween this year.

Easy enough costumes, FDA and cronies go as witches, goblins and monsters.
Vapers go as cowboys in white hats, super heroes and general good guys.

 

[zoiDman]

From the Minute Order...

"Under those circumstances, defendants’ memorandum must explain to the Court: what is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule (which is in effect, and assuming it is not invalidated by the Court) at this time? How would the FDA undertake its case-by-case analysis to determine if a liquid is subject to the Deeming Rule as a “tobacco product” under the statute without the information to be supplied in the pre-market review application, and why would a manufacturer be legally required to submit the application if the liquid was not a “tobacco product” in the first place?"

I think the Bolded Part is something we would All like to know also.

 

[classwife]

boy no kidding !

 

[Eskie]

How would the FDA undertake its case-by-case analysis to determine if a liquid is subject to the Deeming Rule as a “tobacco product” under the statute without the information to be supplied in the pre-market review application

This is really the part I find interesting. The lack of specific guidance on what needs to actually be in the PMTA is a big issue here. I'm glad she picked up on that point, as it's central to understanding how any products will even be allowed on the market under the rules..

 

[zoiDman]

This is really the part I find interesting. The lack of specific guidance on what needs to actually be in the PMTA is a big issue here. I'm glad she picked up on that point, as it's central to understanding how any products will even be allowed on the market under the rules..

I agree.

The concept that the FDA sets a Bar that Applicants must Jump Over, but does not say how High the Bar is, or by what means a Applicant can use to jump over it, is a Ridiculous concept at best.

And it Defies Logic when used to be the Determinant of a Public Health Policy at the Federal Level.

 

[seminolewind]

From the Minute Order...

"Under those circumstances, defendants’ memorandum must explain to the Court: what is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule (which is in effect, and assuming it is not invalidated by the Court) at this time? How would the FDA undertake its case-by-case analysis to determine if a liquid is subject to the Deeming Rule as a “tobacco product” under the statute without the information to be supplied in the pre-market review application, and why would a manufacturer be legally required to submit the application if the liquid was not a “tobacco product” in the first place?"

I think the Bolded Part is something we would All like to know also.

Reading this is really comical. When you step back and take a look at it, this is why you have to settle it in court? It's not as much as the non-tobacco product being deemed as a tobacco product because of intent , it's stupidity on trial here. Spending thousands of dollars and court time to rule whether non nicotine liquid is a tobacco derived product. Case by case is another way to say they can pick and choose who the law applies to . I don't think so. It sounds like the FDA is making this up as they go.

 

[Verb]

Huh, so she still has questions after those oral arguments, with a pretty pointed issue regarding nicotine free liquids being regulated. Now if only the question included hardware to be used with, or intended to be used with a nicotine ejuice could also be considered a tobacco product. Making juice is no issue for me, but I'd like to still be able to obtain vape gear as well.

She didn't give them much time to prepare those filings, either. I guess both sides won't be enjoying Halloween this year.

I don't care about the hardware for nicotine containing liquids. If zero nic liquids are not tobacco products, the hardware I purchase will no longer be a tobacco product either.

 

[skoony]

@Verb I do not see this affecting hardware at all which is disappointing to say
the least. The fact that the nicotine alone may be the key factor seems logical
on the face of it but,the FDA has also stated they are equally concerned with
all the other chemicals and components used. To bad nicotine itself can not
be challenged as having anything to do with being a dependent causing agent
in the form of vaping. IMHO that is where this argument needs to go. I do
not think that this is in the purview of this case or the court system in general .

Perhaps the FDA will throw us this bone. Though it may seem like a major concession
it will be a moot point if the hardware is not exempted.
Mike

 

[seminolewind]

@Verb I do not see this affecting hardware at all which is disappointing to say
the least. The fact that the nicotine alone may be the key factor seems logical
on the face of it but,the FDA has also stated they are equally concerned with
all the other chemicals and components used. To bad nicotine itself can not
be challenged as having anything to do with being a dependent causing agent
in the form of vaping. IMHO that is where this argument needs to go. I do
not think that this is in the purview of this case or the court system in general .

Perhaps the FDA will throw us this bone. Though it may seem like a major concession
it will be a moot point if the hardware is not exempted.
Mike

And what really bites is that all the chemicals in vape liquid have been used for inhalation or eating. Including nicotine . So why all the testing and bs over ingredients that have already been deemed safe years ago. Is there any rule that says how recent the studies have to be? FDA/BP is another swamp that needs to be drained!

 

[seminolewind]

I'm not talking politics here. But I have to laugh at someone running around saying the whole system is rigged and all of Washington dc is rigged and he will be draining that swamp.

But it seems that we all laughed at him, but we are all seeing how true it is. It's like a spider web built on favors and getting to where you need to call them all in. If someone has spent 30 years doing big favors for other people in important positions, it looks to me like it's time for all to return the favor. And that's a super big web of people.

I never bothered with politics until around 2009 when the FDA started messing with us. And it really didn't matter to them that we could see what they were up to. Now I do pay attention to politics more because we all know that the FDA/BP are all a bunch of snakes willing to let millions of people smoke and die for the sake of their money flow. How on earth can you compare a cigarette to a fluid that consists of a few safe items from Walmart? (And nicotine). And those Pennsylvanians threatened with paying a tax per ml- just get the ingredients at the supermarket. And baking goods like flavoring are perfectly legal. Sooner or later what goes around comes around. And they will all hang. Eventually.
They too are in that swamp that needs to be drained.

 

[seminolewind]

deleted............

 

[DragonSG]

Will a vote for Trump trump improve the chances of removing such darning regulations?

 

[bussdriver]

Trump is the only candidate who openly says that excessive regulations need to go. I may agree with other candidates on an issue or two, but on the whole what we need is this removal of regulations.

 

[Eskie]

Will a vote for Trump trump improve the chances of removing such darning regulations?

When the nuclear winter descends after taking office, I'm sure just about all the regulations will be out the window. Fortunately, those of us already prepared for the vapocalypse will be in good shape

 

[Alexander Mundy]

Trump is the only candidate who openly says that excessive regulations need to go. I may agree with other candidates on an issue or two, but on the whole what we need is this removal of regulations.

“In the first debate, voters listened to two candidates dance around the American economy. What you’ll never hear from those candidates is how the economy is being killed by excessive regulation. Vaping, a new industry offering products as a healthier alternative to smoking, is about to be regulated out of existence. That just doesn’t make any sense.
The vaping industry currently counts about nine million customers, producing about $4 billion a year in annual sales. With the excessive regulations recently introduced by the FDA, as many as 12,000 vaping businesses will be put out of business. As Gov. Gary Johnson has said, the free market and entrepreneurial spirit should be encouraged, not destroyed. Nowhere is this more obvious that the vaping industry.”
Jim Wallace, National Director of the Johnson-Weld 2016 campaign

Presidential nominee Gary Johnson calls FDA deeming regs 'excessive'

 

[salemgold]

When the nuclear winter descends after taking office, I'm sure just about all the regulations will be out the window. Fortunately, those of us already prepared for the vapocalypse will be in good shape

This ^^^^^^ Exactly.

 

[salemgold]

I brought some interesting reading with me.
FDA Found Manipulating The Media In Favor Of Big Pharma
UK scientists to WHO: your vape report is junk - Vaping360

 

[Shawn Hoefer]

Will a vote for Trump trump improve the chances of removing such darning regulations?

To get an idea of Trump's stance on vaping (although I do not believe he's ever actually spoken one way or another), one needs only look as far as his running mate, Mike "I shafted Indiana vapers" Pence.

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