Deeming Regulations have been released!!!!

[Rickb119]

most of us wanted desperately to quit and found a method that works for us. It's really stupid that people and government can't see this for what it is.

They (BT, BP, and the Government) most certainly see this for what it is. They see that they are losing millions in revenue and think they have found a way to stop the bleeding. The fact that millions will die as a result of smoking related causes is inconsequential. In fact, from the government viewpoint, it's actually beneficial, i.e. less to pay out in medicare, medicaid, social security, etc.

 

[bigdancehawk]

Ha! Well, I guess having read all these briefs I'm in an excessively adversarial mode.
Now that I understand your question:
The briefing is almost over. There will probably be only one more brief.
The way motion practice works in federal court is this:
1. Somebody files a motion along with with a brief to support it.
2. The other side files its brief opposing the motion.
3. The party who filed the motion gets to reply to the points made in opposition to its motion.
In this case, both sides have filed motions: first, the plaintiffs (Nicopure, etc.) asked for summary judgment and filed their supporting brief. Then the FDA filed its own motion for summary judgment and a combination brief which both supports its motion and opposes the plaintiffs' motion. The plaintiffs have now filed a combination brief which opposes the FDA's motion and replies to the FDA's attack on the plaintiffs' motion. The only thing left is for the FDA to file a reply brief responding to the plaintiffs' attack on its (the FDA's) motion. The FDA has been ordered to do that by September 9, 2016.
In rare instances the court may allow for "sur-replies." A party may not file a sur-reply without the court's permission.
The case is scheduled for oral argument on October 19th. Sometimes following oral argument the judge will ask for further briefing to focus on what she thinks is a decisive issue or possibly something needing more clarification.

ETA: Why, you may ask, did the judge order a 40 day gap from the last brief until oral argument? Several possible reasons: the DC Circuit is one of the busiest courts in the country and dockets are filled up months in advance with trials and hearings. The judge has hundreds of pages to read and she'll probably want to read it all, do some research of her own (or give her law clerks time to do it) before the hearing. She may have a meeting, seminar or vacation scheduled during that time.
These are some of the reasons why state and federal trial court judges want to get appellate court appointments. Appellate work is conducted in a hushed, contemplative, academic-like atmosphere similar to what I imagine the Vatican library must be like. There are no emergency hearings, no contentious wranglings between loud, red-faced lawyers, no difficult, ornery witnesses. Just everybody on their best behavior and in no rush.

 

[salemgold]

Not sure if you guys have seen this yet.

vape APOCALYPSE – PHIL BUSARDO TALKS U.S. FDA MALICE, MISERY & MAYHEM POST 8/8 - REGWATCH
Trigger Warning: strong language used to discuss the FDA

https://www.facebook.com/RegulatorWa...4797073048180/
__________________

 

[zoiDman]

Ha! Well, I guess having read all these briefs I'm in an excessively adversarial mode.
Now that I understand your question:
The briefing is almost over. There will probably be only one more brief.
The way motion practice works in federal court is this:
1. Somebody files a motion along with with a brief to support it.
2. The other side files its brief opposing the motion.
3. The party who filed the motion gets to reply to the points made in opposition to its motion.
In this case, both sides have filed motions: first, the plaintiffs (Nicopure, etc.) asked for summary judgment and filed their supporting brief. Then the FDA filed its own motion for summary judgment and a combination brief which both supports its motion and opposes the plaintiffs' motion. The plaintiffs have now filed a combination brief which opposes the FDA's motion and replies to the FDA's attack on the plaintiffs' motion. The only thing left is for the FDA to file a reply brief responding to the plaintiffs' attack on its (the FDA's) motion. The FDA has been ordered to do that by September 9, 2016.
In rare instances the court may allow for "sur-replies." A party may not file a sur-reply without the court's permission.
The case is scheduled for oral argument on October 19th. Sometimes following oral argument the judge will ask for further briefing to focus on what she thinks is a decisive issue or possibly something needing more clarification.

Correct me if I'm Wrong.

But since Both Parties have filed a Motion for Summary Judgment, if the Judge Grants either Motion, then there would be No Oral arguments. And this Case would be Ruled on based on what each Moving Party has submitted.

 

[Eskie]

Deleted. Missed Lessiefer's post above stating essentially the same.

 

[classwife]

and even provide a self serve packing stuffing machine.

Weren't the tobacco shops required to take those out a couple of years ago ?

 

[classwife]

Weren't the tobacco shops required to take those out a couple of years ago ?

yes
Area smoke shops adjust to ban on roll-your-own machines
The $105 billion federal transportation bill approved June 29 included an amendment reclassifying businesses with the machines as tobacco manufacturers, requiring permits costing thousands of dollars, health warnings on packs and payment of taxes on the cigarettes made.

 

[bigdancehawk]

Correct me if I'm Wrong.

But since Both Parties have filed a Motion for Summary Judgment, if the Judge Grants either Motion, then there would be No Oral arguments. And this Case would be Ruled on based on what each Moving Party has submitted.

The judge will not rule on the motions until after oral arguments. The oral arguments are merely an opportunity for the lawyers to state their positions one last time and, perhaps more importantly, to answer the judge's questions. There will be no witnesses and no evidence will be presented.

 

[skoony]

We were talking about warnings and you've now moved on to inquiries. Which is fine. I'm going to make Alexander Mundy happy and not reply further.

This is fine. Generally I make my points so others are not side tracked by misinformation.
There is a difference between a manufacturer and seller. There is a difference in whats
required to any inquiry by the FDA.

I think the FDA is Smiling right Now. Because they know that this Automatic becoming a Manufacture will not Stand Up to Judicial Review.

It's not automatic. The deeming regs spell out actions that would make you a manufacturer
and those that will not. Think of any retailer selling cigarettes right now(non vape shop) = seller. Basically doing anything more than ringing up the sales = manufacturer. It's not as cut and dried as this
but, basically it's what it is.

Look I am not trying to split hairs here. The FDA has deemed vaping products to be tobacco
products. Ergo we are being treated as tobacco products. No real surprise here.
Once one understands that to the FDA and the law we are all now tobacco users
(not vapers)everything they have done and or trying to do makes sense.
I am not saying it's right,wrong or,anything else.The FDA knows we are different,
so do we. The main concern we should be worried about is convincing the 80%
of the population that doesn't use any tobacco product that arbitrary and onerous
regulations like we have seen lay the ground work for future legislation that will
bite them in the .....

Regards
Mike

 

[Buckeyevapen]

The judge will not rule on the motions until after oral arguments. The oral arguments are merely an opportunity for the lawyers to state their positions one last time and, perhaps more importantly, to answer the judge's questions. There will be no witnesses and no evidence will be presented.

Thanks bigdance.

 

[zoiDman]

The judge will not rule on the motions until after oral arguments. The oral arguments are merely an opportunity for the lawyers to state their positions one last time and, perhaps more importantly, to answer the judge's questions. There will be no witnesses and no evidence will be presented.

Gotcha.

 

[seminolewind]

what exactly constitutes a tobacco related item? If it's nicotine, what happens if the e-liquid is nicotine from another source? In the past hundreds of years, not much has been investigated and researched about nicotine because it was part of "tobacco". I suppose e-liquid sellers going thru a lengthy expensive testing and filing, what if it fails? What would failing mean? Why did tobacco not fail? Why was it "grandfathered" in? Because it is known to fail? Then why is it legal?

PG/VG-has that been approved for human consumption? How about food flavoring? Is a prescription needed for purchasing nicotine? What if the 3/4 items are sold separately? Since marijuana is becoming legal, can the vaping devices be sold as marijuana related? What about all the paraphernalia that was always for sale related to marijuana? It was always available at gas stations.

One thing lawyers know is that researching out cases that are comparable to those cases that are similar, can have a big influence on outcome.

Is there really a source for nicotine that does not come from a tobacco leaf? If smokers have tobacco for nicotine delivery, what would constitute our nicotine delivered in a method that's legal since tobacco is the legal method of supplying nicotine?

Not that we would, it would defeat the purpose. But would it be legal to steep tobacco in fluid like water and vape it? That would be tobacco related, LOL

 

[Lessifer]

yes
Area smoke shops adjust to ban on roll-your-own machines
The $105 billion federal transportation bill approved June 29 included an amendment reclassifying businesses with the machines as tobacco manufacturers, requiring permits costing thousands of dollars, health warnings on packs and payment of taxes on the cigarettes made.

So, it's not a completely ridiculous idea that they would go after shops who are filling tanks for customers? I mean, these were people who bought the tubes and the tobacco, and the shops were just providing the service of stuffing the tubes for them. Heck, they may not have even done any of the work as far as loading the machine or pressing the button, but just provided the machines.

The point is, there is a line between retailer and manufacturer and crossing that line has consequences. Once you are a manufacturer, you are manufacturing a product, and that product must comply with regulations.

 

[bigdancehawk]

Thanks bigdance.

YW!
At the conclusion of oral argument, it's sweet music when the judge asks, "Mr. Bigdance, can you have your proposed findings of fact, conclusions of law and judgment to me within 7 days?" You say, "I certainly can, your honor." Opposing counsel says, "Judge, we'd like to submit ours also." And the judge says, "Of course. Do so if you wish, but that will not be necessary."

 

[zoiDman]

...

The point is, there is a line between retailer and manufacturer and crossing that line has consequences. Once you are a manufacturer, you are manufacturing a product, and that product must comply with regulations.

I don't think there is Any Dispute that there is a Line. It is where that Line lies and what causing someone to go Over the Line that is such a Topic of Debate.

 

[classwife]

what exactly constitutes a tobacco related item? If it's nicotine, what happens if the e-liquid is nicotine from another source? In the past hundreds of years, not much has been investigated and researched about nicotine because it was part of "tobacco". I suppose e-liquid sellers going thru a lengthy expensive testing and filing, what if it fails? What would failing mean? Why did tobacco not fail? Why was it "grandfathered" in? Because it is known to fail? Then why is it legal?

PG/VG-has that been approved for human consumption? How about food flavoring? Is a prescription needed for purchasing nicotine? What if the 3/4 items are sold separately? Since ......... is becoming legal, can the vaping devices be sold as ......... related? What about all the paraphernalia that was always for sale related to .........? It was always available at gas stations.

One thing lawyers know is that researching out cases that are comparable to those cases that are similar, can have a big influence on outcome.

Is there really a source for nicotine that does not come from a tobacco leaf? If smokers have tobacco for nicotine delivery, what would constitute our nicotine delivered in a method that's legal since tobacco is the legal method of supplying nicotine?

Not that we would, it would defeat the purpose. But would it be legal to steep tobacco in fluid like water and vape it? That would be tobacco related, LOL

With 0 nic vaping included in the mess I believe it's not going to matter where the nicotine comes from

 

[zoiDman]

With 0 nic vaping included in the mess I believe it's not going to matter where the nicotine comes from

And that is what Lawsuits are for.

 

[bigdancehawk]

what exactly constitutes a tobacco related item? If it's nicotine, what happens if the e-liquid is nicotine from another source? In the past hundreds of years, not much has been investigated and researched about nicotine because it was part of "tobacco". I suppose e-liquid sellers going thru a lengthy expensive testing and filing, what if it fails? What would failing mean? Why did tobacco not fail? Why was it "grandfathered" in? Because it is known to fail? Then why is it legal?

PG/VG-has that been approved for human consumption? How about food flavoring? Is a prescription needed for purchasing nicotine? What if the 3/4 items are sold separately? Since ......... is becoming legal, can the vaping devices be sold as ......... related? What about all the paraphernalia that was always for sale related to .........? It was always available at gas stations.

One thing lawyers know is that researching out cases that are comparable to those cases that are similar, can have a big influence on outcome.

Is there really a source for nicotine that does not come from a tobacco leaf? If smokers have tobacco for nicotine delivery, what would constitute our nicotine delivered in a method that's legal since tobacco is the legal method of supplying nicotine?

Not that we would, it would defeat the purpose. But would it be legal to steep tobacco in fluid like water and vape it? That would be tobacco related, LOL

I count thirteen questions. That may well be a new ECF record.

 

[bigdancehawk]

So, it's not a completely ridiculous idea that they would go after shops who are filling tanks for customers? I mean, these were people who bought the tubes and the tobacco, and the shops were just providing the service of stuffing the tubes for them. Heck, they may not have even done any of the work as far as loading the machine or pressing the button, but just provided the machines.

The point is, there is a line between retailer and manufacturer and crossing that line has consequences. Once you are a manufacturer, you are manufacturing a product, and that product must comply with regulations.

Not ridiculous at all. But the cigarette making machine prohibition comes directly from an unambiguous statute. Here we have a regulation that's ambiguous and it's based, in turn, on a dubious interpretation of the enabling statute which was never intended to cover what the regulation purports to cover.

 

[seminolewind]

This is fine. Generally I make my points so others are not side tracked by misinformation.
There is a difference between a manufacturer and seller. There is a difference in whats
required to any inquiry by the FDA.


It's not automatic. The deeming regs spell out actions that would make you a manufacturer
and those that will not. Think of any retailer selling cigarettes right now(non vape shop) = seller. Basically doing anything more than ringing up the sales = manufacturer. It's not as cut and dried as this
but, basically it's what it is.

Look I am not trying to split hairs here. The FDA has deemed vaping products to be tobacco
products. Ergo we are being treated as tobacco products. No real surprise here.
Once one understands that to the FDA and the law we are all now tobacco users
(not vapers)everything they have done and or trying to do makes sense.
I am not saying it's right,wrong or,anything else.The FDA knows we are different,
so do we. The main concern we should be worried about is convincing the 80%
of the population that doesn't use any tobacco product that arbitrary and onerous
regulations like we have seen lay the ground work for future legislation that will
bite them in the .....

Regards
Mike

I don't think it's splitting hairs to argue that the ruling of vaping products are tobacco related is not true. It's an inaccurate statement/category, an error. If anything it requires a category of it's own, or labeled ANTI tobacco related. There's a lot of proof that e-liquid is not tobacco related anymore than tomatoes are. That I believe it is the first wrong that needs to be righted. IMO I hate wasting time accepting e-liquid as tobacco related. And it was done without any valid research. I don't think they had enough of anything informative and unbiased and not hearsay. They (FDA) are not being fair to American people to erroneously push vaping under the wrong category and make regulations based on an error. We are American (mostly) people aren't we? We deserve fair treatment under the law. It's biased to shove vaping under tobacco related, including non-nicotine e-liquid.

I think that we have to argue one point at a time starting with vaping mistakenly put in the wrong category of tobacco related products.

A well to do newspaper stated that if the FDA forces us to go black market, they will lose the opportunity to tax us or provide us with fair safety regulations. They will lose their control of everything that is related to vaping. So their laws will not be making us safer. It will be risking our lives with black market untested material. Is that what they want?