Deeming Regulations have been released!!!!

[mikepetro]

Thank you!

And.... Regarding the Cost-benefit analysis ... I thought the FDA were required to do that?

My memory could be wrong..it was a long time ago.

It all hinged on the words "“appropriate and necessary” and "shall". The TCA used the word "shall".

See pages 59-61 of the ruling.

"The tobacco Control Act mandates that tobacco products “shall” be
regulated by the Secretary, and it requires that its provisions be applied not only to conventional
cigarettes, but also to “any other tobacco products that the Secretary by regulation deems to be
subject to this chapter.” 21 U.S.C. § 387a(b). The statute does not limit the Secretary’s authority
to deem to when he finds it “appropriate and necessary” to do so. Therefore, plaintiffs can point
to no source for a requirement that costs be taken into account when the deeming power is
exercised, and Michigan v EPA is distinguishable.28"


"Indeed, the Supreme Court observed that even when the words “appropriate and necessary”
do appear, “[t]here are undoubtedly settings in which the phrase . . . does not encompass cost,”
Michigan, 135 S. Ct. at 2711; there is nothing in the opinion that requires a cost-benefit analysis
when they do not appear."

 

[Robino1]

It all hinged on the words "“appropriate and necessary” and "shall". The TCA used the word "shall".

See pages 59-61 of the ruling.

"The Tobacco Control Act mandates that tobacco products “shall” be
regulated by the Secretary, and it requires that its provisions be applied not only to conventional
cigarettes, but also to “any other tobacco products that the Secretary by regulation deems to be
subject to this chapter.” 21 U.S.C. § 387a(b). The statute does not limit the Secretary’s authority
to deem to when he finds it “appropriate and necessary” to do so. Therefore, plaintiffs can point
to no source for a requirement that costs be taken into account when the deeming power is
exercised, and Michigan v EPA is distinguishable.28"


"Indeed, the Supreme Court observed that even when the words “appropriate and necessary”
do appear, “[t]here are undoubtedly settings in which the phrase . . . does not encompass cost,”
Michigan, 135 S. Ct. at 2711; there is nothing in the opinion that requires a cost-benefit analysis
when they do not appear."

So basically they can do whatever the hell they want.




Disgusting.

 

[mikepetro]

You're using the dark theme, not realizing that white text isn't going to show for those who don't use that theme.

You should leave the color code for white out, letting the software default the text to the default color for the theme.

It did some crazy stuff, embedding 5-6 layers of color codes. My first post had BBCode galore visible in plain text. When I edited out the BBCode I did format some text as white, I should have just edited in RTF and did it the hard way.

 

[retired1]

There's an easy way. Write it all out. Then highlight the text you want to change color and apply the color to the highlighted text.

 

[leftyandsparky]

It did some crazy stuff, embedding 5-6 layers of color codes. My first post had BBCode galore visible in plain text. When I edited out the BBCode I did format some text as white, I should have just edited in RTF and did it the hard way.

It's all good now!

 

[CMD-Ky]

So basically they can do whatever the hell they want.




Disgusting.

Brevity being the soul of wit, you got it. It took the judge 95 pages to say the same thing.

 

[mikepetro]

There's an easy way. Write it all out. Then highlight the text you want to change color and apply the color to the highlighted text.

I went back in and edited the original post, pulled out the errant BBCode, it should be ok now.

 

[Robino1]

I went back in and edited the original post, pulled out the errant BBCode, it should be ok now.

Yes, it is ok now Thanks!

 

[mikepetro]

So basically they can do whatever the hell they want.




Disgusting.

Want one of those coffee mugs?

 

[zoiDman]

...

The Court wishes to reassure the many worried vapers who followed these proceedings closely that this case is not about banning the manufacture or sale of the devices. That is not what the Deeming Rule does or what it was intended to accomplish. In the Deeming Rule, the FDA simply announced that electronic cigarettes, or electronic nicotine delivery systems (“ENDS”) would be subject to the same set of rules and regulations that Congress had already put in place for conventional cigarettes.​

...

I found this Statement to be Particularly Egregious if not Disingenuous.

If it was made by someone with Questionable Intellect or had had Little Knowledge of the Ramifications of the Deeming Rule Set, I could understand it. But Judge Jackson is Not such an Individual.

The Purpose of the FDA's Deeming was to Essentially freeze the Tobacco Market. Accomplished via Exorbitant Cost and Undefined Standards used to grant a PMTA, SE or MRTP market orders.

Pounding the Square Peg of a THR Product into the Round Hole Regulatory Framework of Cigarette guarantees that Almost None of these THR Products will ever reach a consumer. And Stifles current or future Innovations.

And Demonstrates the FDA's Inability to Modernize or even Keep Pace with Beneficial Changes that have occurred in THR.

 

[Robino1]

Want one of those coffee mugs?

Thinkin' 'bout it. Only if I can use it while in front of those up on capital hill........

 

[mikepetro]

I found this Statement to be Particularly Egregious if not Disingenuous.

If it was made by someone with Questionable Intellect or had had Little Knowledge of the Ramifications of the Deeming Rule Set, I could understand it. But Judge Jackson is Not such an Individual.

The Purpose of the FDA's Deeming was to Essentially freeze the Tobacco Market. Accomplished via Exorbitant Cost and Undefined Standards used to grant a PMTA, SE or MRTP market orders.

Pounding the Square Peg of a THR Product into the Round Hole Regulatory Framework of Cigarette guarantees that Almost None of these THR Products will ever reach a consumer. And Stifles current or future Innovations.

And Demonstrates the FDA's Inability to Modernize or even Keep Pace with Beneficial Changes that have occurred in THR.

Yeah, that rang hollow. She knows better.

 

[CMD-Ky]

I found this Statement to be Particularly Egregious if not Disingenuous.

If it was made by someone with Questionable Intellect or had had Little Knowledge of the Ramifications of the Deeming Rule Set, I could understand it. But Judge Jackson is Not such an Individual....

You are an exceedingly generous person, zoiDman.

 

[zoiDman]

Yeah, that rang hollow. She knows better.

Yes, Yes She Does.

But as another person mentioned regarding Her ruling writing, "She Leaves No Gaps".

Because the TCA Specifically States that No Tobacco Market Segment or Product Class can be Banned by the FDA.

 

[zoiDman]

You are an exceedingly generous person, zoiDman.

I believe it is Always a Good Practice to afford a Sitting Judge with a Level of Respect.

Even if I couldn't Disagree more with what they Say and or Do in a particular case.

 

[MacTechVpr]

At this point, I suspect the FDA feels they're caught between a rock and a hard place.

As other governments backtrack on e-cigarette usage and begin to endorse them as a safer alternative to smoking, the FDA is obviously feeling as if they were duped by the various agencies that have continuously lied to them prior to the release of the deeming regulations. To backtrack now would incur the wrath of the anti-vaping crowd along with the majority of politicians who fully believe the FUD that have been spewed by the clueless for years. And considering the FDAs track record on admitting they're wrong, I don't think we'll see any relief from that agency for quite some time.

I found this Statement to be Particularly Egregious if not Disingenuous.

If it was made by someone with Questionable Intellect or had had Little Knowledge of the Ramifications of the Deeming Rule Set, I could understand it. But Judge Jackson is Not such an Individual.

The Purpose of the FDA's Deeming was to Essentially freeze the Tobacco Market. Accomplished via Exorbitant Cost and Undefined Standards used to grant a PMTA, SE or MRTP market orders.

Pounding the Square Peg of a THR Product into the Round Hole Regulatory Framework of Cigarette guarantees that Almost None of these THR Products will ever reach a consumer. And Stifles current or future Innovations.

And Demonstrates the FDA's Inability to Modernize or even Keep Pace with Beneficial Changes that have occurred in THR.

When you empower "expert" bureaucrats as autocrats who can't tell the difference between a leaf and a molecule…what could possibly go wrong?

Good luck.

Thieves respect property; they merely wish the property to become their property that they may more perfectly respect it. -- G. K. Chesterton (The Man Who Was Thursday, 1908)

 

[Eskie]

Well, it does throw a clear and unambiguous (for the moment) answer that it is up to the FDA to establish and enforce regulation as they see fit under the TCA. Which throws this back into the lap of the FDA Commissioner Gottlieb, and indirectly the Secretary of HHS Price. As both have expressed concern about the over regulation of e cigarettes, they can certainly step up and alter the approval path and the enforcement actions without additional intervention. They essentially own it and have the ability to interpret and enforce as they choose.

Now, that's not a great thing if and when new management comes back in down the road and decides to go nuts over it, but it can provide time for legislation that actually accomplishes something in relation to those regulations to be passed.

I still think an appeal will be filed, but whether the appellate court agrees to accept it is unknown.

 

[mikepetro]

I believe it is Always a Good Practice to afford a Sitting Judge with a Level of Respect.

Even if I couldn't Disagree more with what they Say and or Do in a particular case.

I actually do respect her. That document was superb, both in content, and clarity. Her other cases have been also quite noteworthy.

And if I am being objective, she interpreted and followed the law, which is her job.

Its the "law" that we all have a beef with.

 

[zoiDman]

When you empower "expert" bureaucrats as autocrats who can't tell the difference between a leaf and a molecule…what could possibly go wrong?

Good luck.

Who said "they" Don't Know the Difference?

The FDA may appear to be Inept or Not Knowledgeable at times. But that Couldn't be Farther from the Truth.

The Previous FDA/HHS Knew Exactly what they were Doing. And Spent a Lot of Time and Manpower to achieve the outcome that we are currently Enjoying in the e-Cigarette Market.

 

[Robino1]

Who said "they" Don't Know the Difference?

The FDA may appear to be Inept or Not Knowledgeable at times. But that Couldn't be Farther from the Truth.

The Previous FDA/HHS Knew Exactly what they were Doing. And Spent a Lot of Time and Manpower to achieve the outcome that we are currently Enjoying in the e-Cigarette Market.

That ^^^ I have to agree with.

Previous FDA knew exactly what they were doing. They even had sit-downs with CASAA and others that are fighting for us yet still came up with that draconian deeming.

We inadvertently gave them the ammunition with which they proceeded to take aim at us.

They have forever broken our trust. I will Not forget.