FDA FDA response to lawsuits.

[stauglocal]

We are well overdue for a revolution in this country. The federal government is (and has been) out of control, "we the people" have no say in anything anymore. All our politicians are bought and paid for before they even take office. I truly don't know what it will take for the average citizen to wake up and smell the tyranny.

 

[mostlyclassics]

Thanks, bigdancehawk.

Is there any point at which our side can introduce new evidence, etc., or is every step of the ladder on the appeals process just wrangling over what the FDA said in that 499-page deeming regulation?

 

[bigdancehawk]

nm, please delete.

 

[bigdancehawk]

But wasn't that the FDA's problem?

If e-Cigarettes were not "Deemed" to be in the same Category as e-Cigarettes, then they would Fall Outside of their Authority when not Marketed/Advertised as a Drug Delivery device.

I wouldn't exactly say it was their "problem," unless their problem was finding a way to regulate the hell out of every possible thing they could think of. If they had seen their problem as setting some reasonable, objective safety standards for vaping products, they could have gone to the appropriate committees and proposed legislation to give them that authority.

 

[bigdancehawk]

We are well overdue for a revolution in this country. The federal government is (and has been) out of control, "we the people" have no say in anything anymore. All our politicians are bought and paid for before they even take office. I truly don't know what it will take for the average citizen to wake up and smell the tyranny.

I don't believe all politicians are bought and paid for; just most of the ones we keep electing year after year. If you can't even muster enough people to vote for politicians who want to curtail the excesses of government, how are you going to muster enough people to launch a successful revolution? (By "you" I don't mean you personally--I mean people who are extremely unhappy with this mess)

 

[Buckeyevapen]

I don't know if it's Friday, but reply briefs/memoranda are typical and expected in summary judgment proceedings. After the reply memoranda are filed, there may or may not be oral argument. That's up to the judge. The judge will then take it under advisement for as long as she feels is necessary to decide the case and write her decision, and she will enter a written judgment. The judgment will almost certainly be explained in considerable detail ("findings of fact and conclusions of law"). And then there will be an appeal.

Bigdance,
Thank you for all of the clarifications. I really appreciate it and hopefully there are others who do as well.

 

[bigdancehawk]

Thanks, bigdancehawk.

Is there any point at which our side can introduce new evidence, etc., or is every step of the ladder on the appeals process just wrangling over what the FDA said in that 499-page deeming regulation?

It would be extremely unusual if any new evidence is allowed. The judge has already refused to let CASAA intervene in the case because they wanted to talk about stuff that wasn't in the administrative record and she wouldn't have any part of that. (She was correct). New evidence would probably be allowed to prove that the FDA officials were bribed or something like that. That would be sweet, but I don't see it happening.

So yes, the case is purely an attack on those 499 pages. The attack must be based only on evidence that was presented to the FDA, on legal precedent, on statutory language and on constitutional principles.

 

[Ed_C]

Make that, the politicians that can afford to run a winning campaign are bought and payed for.

 

[bigdancehawk]

Bigdance,
Thank you for all of the clarifications. I really appreciate it and hopefully there are others who do as well.

You're entirely welcome. It's an interesting topic. I guess I'm like a car mechanic who talks about cars on his days off, or a chef blabbering on about food between innings at the ball game.

 

[zoiDman]

I wouldn't exactly say it was their "problem," unless their problem was finding a way to regulate the hell out of every possible thing they could think of. If they had seen their problem as setting some reasonable, objective safety standards for vaping products, they could have gone to the appropriate committees and proposed legislation to give them that authority.

To me, one of the Biggest Problem the FDA saw was they were Not Content to just Regulate e-Liquids that contained Nicotine derived from Tobacco.

They Wanted/Want Complete Control over Every Aspect of e-Cigarettes. So they had to use Regulatory Over-Reach to include things like 0mg or Intended Use.

 

[Buckeyevapen]

It would be extremely unusual if any new evidence is allowed. The judge has already refused to let CASAA intervene in the case because they wanted to talk about stuff that wasn't in the administrative record and she wouldn't have any part of that. (She was correct). New evidence would probably be allowed to prove that the FDA officials were bribed or something like that. That would be sweet, but I don't see it happening.

So yes, the case is purely an attack on those 499 pages. The attack must be based only on evidence that was presented to the FDA, on legal precedent, on statutory language and on constitutional principles.

I did notice the laundry list of precedents listed by the FDAs response.
In terms of statutory language I would presume that even the original act drawn up by congress would be included as it is sited in the seeming. And such documents might be a fulcrum for an argument that vapor products could not have been included in the intent of that act as no vapor products existed or the definition which congress its self used to define what a tobacco product is.

Sounds like both sides have to have very clean and well thought out arguments ready for the judge once something gets to this level.

Thank you again and please keep the insights coming they are very helpful for my/our understanding.

 

[mostlyclassics]

So yes, the case is purely an attack on those 499 pages. The attack must be based only on evidence that was presented to the FDA, on legal precedent, on statutory language and on constitutional principles.

Thanks for the clarification, bigdancehawk.

Sigh.

 

[bigdancehawk]

To me, one of the Biggest Problem the FDA saw was they were Not Content to just Regulate e-Liquids that contained Nicotine derived from Tobacco.

They Wanted/Want Complete Control over Every Aspect of e-Cigarettes. So they had to use Regulatory Over-Reach to include things like 0mg or Intended Use.

Exactly. There seems to be no such thing as moderation when it comes to regulation. Yes, they could have set some objective, easily understood purity standards for the liquids and forbidden certain ingredients. But they can't just start out with a little regulating, see how it works, and then adjust, adding or subtracting incrementally as needed. Oh, no! The cheeldreen must be saved! So they swoop down with mighty sledgehammers, swinging wildly and smashing up everything. When is the last time that sort of approach to regulation was successful?

 

[mostlyclassics]

bigdancehawk, let's say for the moment that the FDA prevails against these lawsuits.

Does such a victory then set them up legally to start fining vapers and/or confiscating their vaping gear and supplies? Or would such a move be beyond their reach?

Can they actually criminalize vaping, all by their lonesome, via regulations?

 

[WorksForMe]

So yes, the case is purely an attack on those 499 pages. The attack must be based only on evidence that was presented to the FDA, on legal precedent, on statutory language and on constitutional principles.

I guess this is why @Bill Godshall put in that really, really long comment to the FDA when they first proposed the Demon regs. He included lots of studies and other evidence. He said he wanted to have it all on the record before this went to court. Very few of us really understood that at the time.

ETA: Comments by Bill Godshall and Smokefree Pennsylvania urge FDA to reject Deeming Regulation, correct fear mongering claims about e-cigs

 

[Buckeyevapen]

I guess this is why Bill G. put in that really, really long comment to the FDA when they first proposed the Demon regs. He included lots of studies and other evidence. He said he wanted to have it all on the record before this went to court. Very few of us really understood that at the time.

ETA: Comments by Bill Godshall and Smokefree Pennsylvania urge FDA to reject Deeming Regulation, correct fear mongering claims about e-cigs

Indeed!

 

[bigdancehawk]

Exactly. There seems to be no such thing as moderation when it comes to regulation. Yes, they could have set some objective, easily understood purity standards for the liquids and forbidden certain ingredients. But they can't just start out with a little regulating, see how it works, and then adjust, adding or subtracting incrementally as needed. Oh, no! The cheeldreen must be saved! So they swoop down with mighty sledgehammers, swinging wildly and smashing up everything. When is the last time that sort of approach to regulation was successful?

ETA: I saw an interview of a young FDA official in their tobacco control group. She seemed like a nice young lady, but all full of herself with idealism, an ambition to to great things, and a burning need to make everything right, save the cheeldreen, and all of that.

 

[Kent C]

ETA: I saw an interview of a young FDA official in their tobacco control group. She seemed like a nice young lady, but all full of herself with idealism, an ambition to to great things, and a burning need to make everything right, save the cheeldreen, and all of that.

Their last resort in the face of all their failed programs is: 'we cared', yet they promoted the programs with the same words before their failures. At some point, people may get that the 'well intended' just don't know how to get their intended results. OR that they never really intended that in the first place. That they really wanted people dependent on them and their politics.

 

[Semiretired]

When is the last time that sort of approach to regulation was successful?

Personally - I am hoping that that is their downfall. They just took it to an extreme and any judge should be able to see that.

My one question - does the judge read the entire deeming reg or do they get foot notes???

 

[Ed_C]

My one question - does the judge read the entire deeming reg or do they get foot notes???

They had better read the whole freaking thing or I don't know what we are paying them for!