Deeming Regulations have been released!!!!

[ENAUD]

Labor day sales are going to be huge this year...

 

[440BB]

Some relief through this lawsuit was what I was counting on. Things seem bleak right now.

 

[Shawn Hoefer]

There is still legislation in play... nothing is set in stone.

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[zoiDman]

November 2017 is when vendors have to have their products registered with the FDA, right?

I believe this is an up to date Calendar of Compliance Dates.

https://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM501016.pdf

 

[Eskie]

BTW - If anyone doesn't understand what the Chevron Doctrine is, or what concept of Judicial Deference implies, here is a Nice and Concise explanation...

"The origins of the [Cheveron] Doctrine aren’t especially political. The original opinion was written by Justice John Paul Stevens, then still a moderate Republican in the mode of Gerald Ford, who appointed him. (Stevens later became a liberal, one of the most outspoken on the Rehnquist court.

Stevens’s basic reasoning was that when Congress passed a law that did not have a clear meaning, the agency charged with applying the law should have the first crack at interpreting it. This made sense against the background of the now somewhat-old-fashioned idea that agencies are politically neutral experts whom Congress trusts to make wise decisions.

Given the agency’s expertise in the subject matter, Stevens reasoned, the agency should have the authority to choose among potentially conflicting policy choices. Provided the agency’s interpretation was reasonable, the court should defer to it.


The court’s job was then twofold. First, in what came to be called step one of the Chevron doctrine, the court must determine if the law was in fact ambiguous. If it was, then at step two, the court was supposed to decide if the agency interpretation was reasonable."

Supreme Court Fans, Brush Up on the Chevron Doctrine

Eh, you can always find grounds to appeal. Whether the appeals court accepts it is another matter. Even under the Chevorn Doctrine, that can only be invoked if the " when Congress passed a law that did not have a clear meaning, the agency charged with applying the law should have the first crack at interpreting it." So, first crack doesn't mean last crack.

And "the agency should have the authority to choose among potentially conflicting policy choices. Provided the agency’s interpretation was reasonable, the court should defer to it.". Reasonable interpretation is a biggie here, and open to interpretation, thus, appeal. Happens all the time especially with agencies like the EPA (and almost always ends up appealed).

Let's face it, when the TCA was enacted, ENDS didn't exist. To apply a law onto a product which didn't exist prior to the act's existence isn't merely a vague and ambiguous circumstance. The reason this whole thing started with "vaping is tobacco", which goes back to the "you can't regulate this as a drug" way back when, with the provision of the court (don't remember the judge or title on this lawsuit, but others with proper memory can likely provide it) was you can TRY and regulate it as tobacco. If that interpretation of that ruling is to provide them with the power to regulate it as tobacco is certainly subject to appeal as, to the best of my knowledge, not ordered that they HAD to treat it as tobacco.

If anything, it turns up the dial on legislative action as, in the eyes of legislators who care, unable to provide judicial relief. And I'm reasonably sure the plaintiff's lawyers are already working on that appeal, even over this weekend. Let's face it, billable hours are billable hours. And there are lots of hours to bill for on a case like this.

The real question in relation to an appeal is whether the plaintiff's have the funds and are willing to commit to an appeal is probably of greater concern than can it be appealed.

 

[zoiDman]

Eh, you can always find grounds to appeal. Whether the appeals court accepts it is another matter. Even under the Chevorn Doctrine, that can only be invoked if the " when Congress passed a law that did not have a clear meaning, the agency charged with applying the law should have the first crack at interpreting it." So, first crack doesn't mean last crack.

And "the agency should have the authority to choose among potentially conflicting policy choices. Provided the agency’s interpretation was reasonable, the court should defer to it.". Reasonable interpretation is a biggie here, and open to interpretation, thus, appeal. Happens all the time especially with agencies like the EPA (and almost always ends up appealed).

Let's face it, when the TCA was enacted, ENDS didn't exist. To apply a law onto a product which didn't exist prior to the act's existence isn't merely a vague and ambiguous circumstance. The reason this whole thing started with "vaping is tobacco", which goes back to the "you can't regulate this as a drug" way back when, with the provision of the court (don't remember the judge or title on this lawsuit, but others with proper memory can likely provide it) was you can TRY and regulate it as tobacco. If that interpretation of that ruling is to provide them with the power to regulate it as tobacco is certainly subject to appeal as, to the best of my knowledge, not ordered that they HAD to treat it as tobacco.

If anything, it turns up the dial on legislative action as, in the eyes of legislators who care, unable to provide judicial relief. And I'm reasonably sure the plaintiff's lawyers are already working on that appeal, even over this weekend. Let's face it, billable hours are billable hours. And there are lots of hours to bill for on a case like this.

The real question in relation to an appeal is whether the plaintiff's have the funds and are willing to commit to an appeal is probably of greater concern than can it be appealed.

I don't think Raising Funds for an Appeal are going to be an insurmountable problem. As the Lawyer say'n goes, "It's Easier to Sell Lifeboats when passengers have just been thrown in the water than it is when they are Standing on the Deck."

I think what Our Biggest Enemy now is Time.

---

Just seems Ironic that Countries like England, Australia and New Zealand are coming around to the Idea of Embracing e-Cigarettes as THR based on Health/Science Data. While we in the USA are stuck with a Backward Thinking FDA who is intend on pounding the Square Peg of e-Cigarettes into the Round Hole of Combustible Tobacco Policy.

 

[zoiDman]

...

Let's face it, when the TCA was enacted, ENDS didn't exist. To apply a law onto a product which didn't exist prior to the act's existence isn't merely a vague and ambiguous circumstance. ...

And this is Why I Didn't think that a Federal Judge would apply so much Judicial Deference to the FDA in this lawsuit.

Especially seeing that the mission of the FDA is supposed to Protect/Increase Public Health. And Grandfathering about Every Cigarette ever made and Hammering e-Cigarettes a Reasonable Person would say does the Direct Opposite.

 

[stols001]

Well, I showed up here not too long ago, and it wasn't the FDA or Tobacco Control. I genuinely couldn't figure out my setup/juice and wound up with a mtl vape, which works well for me. And hung around for the interest. But, I think there were others vaping like me, and got the information they needed. Some do stay, some don't. But, it wasn't deeming regs that kept me here, though I do find them horrifying. And thanks to the courts for the Nicopure lawsuit. Sigh. Political items coming down the pike, of course they will be allowed to proceed. Sigh. I was pretty interested in deeming, but only so much as I can keep vaping, and figure out supplies that work.

I think it's unfair to demonize smokers who are still smoking.... They need to figure out to vape, and how to do it. It was years before I became desperate enough to vape, full-time, and even then I wasn't explained all things vape until I came here.

Hopefully ecf will be around for quite a while longer.

Anna

 

[Bronze]

Not to get too political, but why did we ever allow our elected representatives to hand over so much power and responsibility to non-elected persons? Not just these agencies but also appointed judges? Sorry, I'll stop now. I just get so disgusted.

There are some people who like telling others how to live their lives. Both elected and non-elected. They get off on it. They are the Gladys Kravitz of our society.

There is still legislation in play... nothing is set in stone.

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Agree. Dates get shoved back for a reason.

 

[jazzman10]

The government is happy to tell you how to live your life.

 

[Stubby]

And "the agency should have the authority to choose among potentially conflicting policy choices. Provided the agency’s interpretation was reasonable, the court should defer to it.". Reasonable interpretation is a biggie here, and open to interpretation, thus, appeal. Happens all the time especially with agencies like the EPA (and almost always ends up appealed).

Let's face it, when the TCA was enacted, ENDS didn't exist. To apply a law onto a product which didn't exist prior to the act's existence isn't merely a vague and ambiguous circumstance. The reason this whole thing started with "vaping is tobacco", which goes back to the "you can't regulate this as a drug" way back when, with the provision of the court (don't remember the judge or title on this lawsuit, but others with proper memory can likely provide it) was you can TRY and regulate it as tobacco. If that interpretation of that ruling is to provide them with the power to regulate it as tobacco is certainly subject to appeal as, to the best of my knowledge, not ordered that they HAD to treat it as tobacco.

If anything, it turns up the dial on legislative action as, in the eyes of legislators who care, unable to provide judicial relief. And I'm reasonably sure the plaintiff's lawyers are already working on that appeal, even over this weekend. Let's face it, billable hours are billable hours. And there are lots of hours to bill for on a case like this.

The real question in relation to an appeal is whether the plaintiff's have the funds and are willing to commit to an appeal is probably of greater concern than can it be appealed.

Vaping certainly did exist when TCA was passed (2009). Vaping may not have been the main target of the bill, but the intent of the law is clear, and that is that the FDA has authority to regulate any new tobacco product that comes on the market. The TCA gives the FDA a broad reach and vaping is well within that reach.

That lawsuit was weak because it claimed (okay, I'm not a lawyer, but from what I understand) the FDA did not specifically have authority over vaping, and the TCA was not specifically written with vaping in mind. But the TCA was written so that the FDA could deem new tobacco products that came on the market, which is exactly what the FDA did. The judges ruling is correct and any appeals are going to have a hard time of it.

The problem is not that the FDA overstepped its authority, the problem is that the TCA clearly gives the FDA the authority to do exactly what it did with vaping. The core problem is that the TCA is very likely one of the worst bills ever written. It has been called the Marlboro protection act by those in the know, because that is what it really does. It protects the statues que (of 2007). It freezes the market. The intention of the TCA was to stifle innovation.

It is hard to see how the judge could have ruled any other way when she was dealing with the TCA. The FDA does have authority to be quite flexible in how it regulates tobacco products, but the FDA, in its current state choose to interpret vaping at the strictest level, but it didn't overstep its authority.

 

[Lessifer]

Vaping certainly did exist when TCA was passed (2009). Vaping may not have been the main target of the bill, but the intent of the law is clear, and that is that the FDA has authority to regulate any new tobacco product that comes on the market. The TCA gives the FDA a broad reach and vaping is well within that reach.

That lawsuit was weak because it claimed (okay, I'm not a lawyer, but from what I understand) the FDA did not specifically have authority over vaping, and the TCA was not specifically written with vaping in mind. But the TCA was written so that the FDA could deem new tobacco products that came on the market, which is exactly what the FDA did. The judges ruling is correct and any appeals are going to have a hard time of it.

The problem is not that the FDA overstepped its authority, the problem is that the TCA clearly gives the FDA the authority to do exactly what it did with vaping. The core problem is that the TCA is very likely one of the worst bills ever written. It has been called the Marlboro protection act by those in the know, because that is what it really does. It protects the statues que (of 2007). It freezes the market. The intention of the TCA was to stifle innovation.

It is hard to see how the judge could have ruled any other way when she was dealing with the TCA. The FDA does have authority to be quite flexible in how it regulates tobacco products, but the FDA, in its current state choose to interpret vaping at the strictest level, but it didn't overstep its authority.

I know you and I don't agree much, but I agree with you here.

For me it's always been about either changing the FSPTCA, since it is horrible legislation that actively discourages the development and promotion of low risk tobacco products.

Or

Explicitly remove vaping from the purview of the FSPTCA.

I know we disagree on which one of those is more likely to happen, both would be legislative solutions, either would be acceptable to me.

 

[stols001]

Lessifer, I agree with you too, actually. The deeming issue and handing vaping over to FDA/BT is not fair. They didn't develop those products. In FACT, they could have done vaping for ages, one of my pdocs in '99 (while soulfully staring at me sadly and recommending prescription nicotine device, I think one of the throat or nose sprays) after turning me down flat for Chantix, said this, "You know, back in the 60s, tobacco makers got together and investigated non-burning products due to the fact that so many smokers would be hearing negative data, could have easily-- and did investigate-- these products before turning them down thinking the market wouldn't want to deal with them. He told me bunches of suff, but this particular psychiatrist knew EVERYTHING it seemed like, so I tend to credit what he said.

So, BT, you could *own* the vaping market but you were more worried about people not smoking? I guess you lost, eh, you are behind the times and now these regs are causing YOU to have to take products off the market, as they are new? I'm talking to you, Camel crush, which was my son's go to cigarette when he was smoking/starting vaping. So, that stuck in your mind, I guess, as I found them so gross I was NOT going to smoke one. I deem these "Rehab cigarettes" due to the number I saw while visiting my little prince at rehab, there were so many packs of those Camels in there.... So, BT, whether you voluntarily chose to get rid of those few products, and picked them from a "random glass of smokes I'm willing to lose", don't forget that the FDA actually got rid of them. So maybe BT is feeling a bit nervous, it's possible. I don't know if this is a "preemptive deem," to remove the anger and annoyance for vapers just a little down the road. I hope not, I hope it was genuine.... But, I'm not holding my breath.

Anna

 

[zoiDman]

...

The problem is not that the FDA overstepped its authority, the problem is that the TCA clearly gives the FDA the authority to do exactly what it did with vaping. The core problem is that the TCA is very likely one of the worst bills ever written. It has been called the Marlboro protection act by those in the know, because that is what it really does. It protects the statues que (of 2007). It freezes the market. The intention of the TCA was to stifle innovation.

...

The TCA did Exactly what those who voted for it Wanted it to do. To Stop New Products from entering into Combustible Tobacco market. And to give the FDA Unified and Complete Control over it.

There might have been an Extremely Small e-Cigarette market in March 2009. But congressional knowledge of e-Cigarettes was Ziltch. It wasn't until after the TCA had passed, and the FDA got a Slap Down in Federal Court over e-Cigarettes, that Regulators realized that e-Cigarettes could be swept up into the TCA.

That, is where the Problem Started.

And the Problem was Compounded because Many of those who tried an e-Cigarettes found that they Actually Worked as a means to Quit Paying Cigarette Taxes. I mean Quit Smoking.

 

[stols001]

That's a depressing (if not new but plausable) set of theories.

Gah, politicans are the master of taxation, that is for sure.

Anna

 

[zoiDman]

The TCA did Exactly what those who voted for it Wanted it to do. To Stop New Products from entering into Combustible Tobacco market. And to give the FDA Unified and Complete Control over it.

There might have been an Extremely Small e-Cigarette market in March 2009. But congressional knowledge of e-Cigarettes was Ziltch. It wasn't until after the TCA had passed, and the FDA got a Slap Down in Federal Court over e-Cigarettes, that Regulators realized that e-Cigarettes could be swept up into the TCA.

That, is where the Problem Started.

And the Problem was Compounded because Many of those who tried an e-Cigarettes found that they Actually Worked as a means to Quit Paying Cigarette Taxes. I mean Quit Smoking.

BTW - What was the Original date of the Introduction of the Family Smoking and Tobacco Control Act?

Spoiler: Hint

What is the Predicate Date?

 

[stols001]

So June 22, 2009? Oh obama. I kind of liked that dude (and as a speaker he was almost hypnotic, which is a good trait if you want the youth vote, and enjoyed some of his policies, even. I MOST enjoyed him crumbling in office with Obamacare, I mean what he GOT was certainly not what he wanted, I could see his face, "Are we, as Americans, this dumb?" and his increasingly agitated speeches, LOL.

That said, he's a bit to socialistic for me, even. There was no need for this legislation, OBAMA you SMOKE yourself. Are you trying to get yourself to quit? There were some other ones that I just felt were freaking passive aggressive. Like the bathroom thing. Lets all face it, the only time that would be safe would be after middle school, and transgender kid will get HARRIED to the point that.... Well, let me just say that I know a bunch of "the alphabet people" the nicknames just get too hard to pick up with.... Depending on their "gender" and if they are "transgendring" and think they can pass, they go to the bathroom of their choice. If they can't, it's just going to lead to satan's little minion downstairs, and being allocated a slot there.

My favorite transgender chick is clearly male, she dresses like a man but makes up her face and wears earrings sometimes. I will call her Sarah, but my favorite thing about her EVER is she comes to my AA homegroup. She merely introduces herself as Sarah, but *will not speak of her being transgender," even if you asked, but you wouldn't because she is so natural in her being, it's not even necessary. She's like, "I'm here for AA."

She isn't on estragen though, that makes the difference. Some of the more obnoxious transgender, I have run into are usually on transitioning, and that makes for the insanity. All the hormones. Just my opinion, but everyone can do what they want.

That last one I spoke about was an executive order, so Obama is entirely to blame. And he knew what he was doing.

I like many things about Obama, but his intense pressure for globalization, handling of health care, then becoming passive agressive on purpose isn't' one of them. I should see who authored it, though the admin was fully in place, then. Obama had his hand in the tip jar, though, I'm certain. He was like, "Those peons of SMOKERS, of whom I am one, must be TAXED." I don't understand the logic.... Well, I mean, I do, but huh?

Anna

 

[Stubby]

The TCA did Exactly what those who voted for it Wanted it to do. To Stop New Products from entering into Combustible Tobacco market. And to give the FDA Unified and Complete Control over it.

There might have been an Extremely Small e-Cigarette market in March 2009. But congressional knowledge of e-Cigarettes was Ziltch. It wasn't until after the TCA had passed, and the FDA got a Slap Down in Federal Court over e-Cigarettes, that Regulators realized that e-Cigarettes could be swept up into the TCA.

That, is where the Problem Started.

And the Problem was Compounded because Many of those who tried an e-Cigarettes found that they Actually Worked as a means to Quit Paying Cigarette Taxes. I mean Quit Smoking.

It wasn't just the combustable market that got regulated, it was all tobacco products, including smokeless tobacco.

From a judicial prospective it doesn't matter if the law was not specifically written with vaping in mind. If you interpret the law as written it has very broad reach and the FDA has clear authority to deem vaping.

 

[Eskie]

And thanks to a Friday release, there will be no official reaction from either side until next week. That's when things will get interesting.

 

[Shawn Hoefer]

It wasn't just the combustable market that got regulated, it was all tobacco products, including smokeless tobacco.

From a judicial prospective it doesn't matter if the law was not specifically written with vaping in mind. If you interpret the law as written it has very broad reach and the FDA has clear authority to deem vaping.

Whereas I do not dispute that under the relevant rules, laws, and regs the FDA had the right to regulate vaping, I still feel that there was a considerable overreach. They have given themselves an incredible amount of lattitude by using theword intent, but never defining it in this context. Are tampons tobacco products? Yes...

The other issue is the predicate date. No agency should have to power to arbitrarily set an entire industry back a decade because they, as an agency, were slow catching on.

Further, enforcement will be a nightmare...

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