Deeming Regulations have been released!!!!

[Buckeyevapen]

I'm reading their response now. It's so challenging to read it not from the perspective of someone who knows that this product got me off of cigarettes but from a judges point of view. I keep asking myself: what would an impartial individual make of these arguments?

Where is bigdance? I can't wait to hear from those with a law back ground have to say about the FDAs retort.

 

[Buckeyevapen]

In my simplistic mind the FDA fails to address the central theme: just because you say something is made of tobacco doesn't make it true. Everything in their argument requires the assumption that my mod, the 18650s, the tank of steel and glass is made of tobacco. And THAT simply is not factual. There argument requires me to accept their authority to "deem" what something is and is not. As I have said before their stance is arrogant in its approach and assumptive in nature. Of course I am indeed a biased reader.

 

[Mazinny]

Vaping is paying for the sins of BT.

The FDA pretty much says this in their response :

Plaintiffs assert that there is “powerful evidence” that e-cigarettes are safer than cigarettes, but tobacco companies long made similar assertions regarding “low tar” cigarettes. See Philip Morris, 566 F.3d at 1107. Rather than accept piecemeal evidence of the kind Plaintiffs cite, Congress instructed the FDA to review products that purportedly reduce health risks to ensure that they “actually reduce such risks.” Legislative Finding 37.

 

[Mazinny]

In my simplistic mind the FDA fails to address the central theme: just because you say something is made of tobacco doesn't make it true. Everything in their argument requires the assumption that my mod, the 18650s, the tank of steel and glass is made of tobacco. And THAT simply is not factual. There argument requires me to accept their authority to "deem" what something is and is not. As I have said before their stance is arrogant in its approach and assumptive in nature. Of course I am indeed a biased reader.

Not to nitpick, but that is not what the FDA says. They use this provision of the TCA to claim congress has given them authority to regulate components, which they claim mods and tanks are ( 18650's will not be regulated under deeming ):

TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

[*101] Sec. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) Definition of Tobacco Products.--Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321) is amended by adding at the end the following:

"(rr) (1) The term 'tobacco product' means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).


Even if the Court were not constrained by Sottera, it should reject Plaintiffs’ claim that e
cigarettes with refillable tanks are exempt from regulation under the Tobacco Control Act. The
statute broadly defines “tobacco product” to include not only products “made or derived from
tobacco,” but also any “component, part, or accessory” thereof—whether or not made or derived
from tobacco. 21 U.S.C. § 321(rr)(1); Defs.’ Br. 25–33. Congress left the terms “component,
part, or accessory” undefined, and the FDA’s interpretation of them merits substantial deference
under Chevron—a case that Plaintiffs relegate to a footnote. Pls.’ Reply 6 n.2.

 

[seminolewind]

The FDA pretty much says this in their response :

Plaintiffs assert that there is “powerful evidence” that e-cigarettes are safer than cigarettes, but tobacco companies long made similar assertions regarding “low tar” cigarettes. See Philip Morris, 566 F.3d at 1107. Rather than accept piecemeal evidence of the kind Plaintiffs cite, Congress instructed the FDA to review products that purportedly reduce health risks to ensure that they “actually reduce such risks.” Legislative Finding 37.

Well, let's see. we have powerful evidence, but BT has been saying that for years with low tar cigarettes. What do BT's lies have to do with our evidence? comparing apples to oranges? We gave piecemeal evidence ? FDA avoided the important subjects with really stupid replies that contain more heresay and personal opinion rather than a factual reply.
Will a judge at least knock out their replies based on BT's lies? Or that they state facts when no study has been done? They did a bunch of nothing if they can sit their fat butts there and say there is no correlation between smoking cessation and the use of vaping products. Gee, every vaper I know is a former smoker.

I think our plaintiff might ask "prove it" to any of FDA's statements. Show us the study or polls. Show us any factual evidence to back up your position. They can't . The Only ALmost "factual "study done is actually BT studying how many people are giving up smoking to vape. Does that not speak volumes?

Our plaintiffs have had 10 years of being educated on vaping products just by being aware, interested, and starting a business based on lower harm, not to mention our studies and associations that do focus on education. How much education does the FDA have? None. I think their poor replies show that they were unprepared for a plaintiff who did have evidence. I think they thought that this suit would be a drop in the bucket to win. After all, those plaintiffs "vape" so they can't be much competition.

 

[bigdancehawk]

I'm reading their response now. It's so challenging to read it not from the perspective of someone who knows that this product got me off of cigarettes but from a judges point of view. I keep asking myself: what would an impartial individual make of these arguments?

Where is bigdance? I can't wait to hear from those with a law back ground have to say about the FDAs retort.

Ha! I'm here. Dissecting and tearing this abomination apart may take awhile--hours to do a proper job. I hope it will be possible to listen to oral argument.

Note that high ranking lawyers in the U.S. Attorney General's office are now lending a hand. Eight lawyers on this brief from two arms of the executive branch. Your taxpayer dollars are hard at work, saving the cheeldreen from the horrors of nicotine addiction and exposure to vast quantities of toxic substances. Can you possibly imagine a higher priority for our pubic officials?

I gotta get some sleep now and tend to paying business tomorrow. But it's been interesting to read the reactions of other forum members so far. Do you get the sense that people here are extremely PO'd to see what the executive branch of their government is up to? This is exactly what happens when your elected legislators cede legislative power to bureaucrats. The overall theme of the brief is: "This is what Congress has given us the unfettered discretion to do."

 

[bigdancehawk]

Color me a pessimist but I actually think the FDA's response is pretty solid.

You're right. It's better than I expected.

 

[bigdancehawk]

The correct term is Mumbo Jumbo.

For a legal brief, it's not bad. There are a number of head scratchers, but that's not because of legal jargon. It's because they are garbage arguments designed to confuse the issue and mislead the court. Hardly unusual. For the most part, however, it's a decent piece of legal writing. I'd give it A- or B+.

 

[bigdancehawk]

Thanks for this.

Any chance you can find out what is going on with the other lawsuits. I tried but couldn't find any court documents.

Lost Art Liquids, LLC v. FDA, Case No. 2:16-cv-3468 (C.D. Cal. 2016)

Cyclops Vapor 2 LLC, et al v. FDA, et al, Case No. 2:16-cv-00556 U.S. District Court for the Middle District of Alabama.

Larry W. Faircloth v. FDA, Case No. 2:16-cv-5267 (S.D. W.V. 2016)

Yeah, I can do that. But with a PACER account you can get access too. I think it's ten cents per page up to a max of $3 per document.

 

[Sugar_and_Spice]

Do you get the sense that people here are extremely PO'd to see what the executive branch of their government is up to? This is exactly what happens when your elected legislators cede legislative power to bureaucrats. The overall theme of the brief is: "This is what Congress has given us the unfettered discretion to do."

Yep, that would be me. Passing on their responsibility in favor of their holidays, perks and pensions.

 

[Bea-FL]

Yep, that would be me. Passing on their responsibility in favor of their holidays, perks and pensions.

And lets not forget voting in raises for themselves.

When I was an office manager, my new employees had to go through a 90 day review after hire and annual reviews after that. And if their performance was unsatisfactory we had provisions for termination if there was no improvement in job performance. Raises were based on merit…so why dont our elected officials have to go through something like that too? After all we basically hire them to do a job for us…they work for us!

If you ever want to see a good movie watch "Dave" with Kevin Kline. It should be mandatory for every elected official to watch it.

 

[retired1]

And lets not forget voting in raises for themselves.

Raises are automatic. This is so they can say they didn't vote for a raise each year. To stop the raise from kicking in on a given year, Congress has to vote to prevent it from happening.

 

[Bea-FL]

Raises are automatic. This is so they can say they didn't vote for a raise each year. To stop the raise from kicking in on a given year, Congress has to vote to prevent it from happening.

Well then there should be a system whereby they get reviewed and get raises based on merit or not. The rest of us do.

In case you couldnt tell this is one of my biggest governmental pet peeves. No reviews and merit raises means "business as usual". No incentive to do better.

 

[KODIAK (TM)]

While the FDA's authority comes from the Tobacco Control Act, their arrogance/confidence in this authority seems to hinge on this:

1. The FDA’s Interpretation of the Tobacco Control Act Is Entitled to Chevron Deference

In interpreting a statute that the FDA is entrusted to administer, the Court follows “the familiar two-step framework of Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842–43 (1984).” Sherley v. Sebelius, 644 F.3d 388, 393 (D.C. Cir. 2011). Under Chevron step one, if Congress has “‘directly spoken to the precise question at issue,’” then the Court must “‘give effect to [its] unambiguously expressed intent.’” Id. (quoting Chevron, 467 U.S. at 843). If instead the “‘statute is silent or ambiguous with respect to the specific issue,’” then, under Chevron step two, the Court must “defer to the administering agency’s interpretation as long as it reflects ‘a permissible construction of the statute.’” Id. (quoting Chevron, 467 U.S. at 843).

This Chevron Deference is basically a process for the courts to determine if the FDA used a constructive interpretation of the statute - meaning, the FDA must show how it connected the "dots" that aren't in the original writing itself; even if those dots lead to a wrong (unscientific in this case) conclusion. (i.e., it's not the court's job to tell Congress they are dumb-asses).

This Chevron Deference sprinkled with a lot of "Sottera" references in that brief tell me the Judge has an easy way out if she so choses.

 

[salemgold]

I was just reading this post and article posted by
A Billion Lives and thought I would share.

The events we do all over the world...have a global impact.

This doctor changed her mind during our European Premiere! Now she's writing articles. What will happen if we can get #ABillionLives to your city...to your doctor?

Get ready.


A chance to breathe - Drink and Drugs News

 

[Bea-FL]

A chance to breathe - Drink and Drugs News

Great article. Too bad the powers to be who are making the rules wont care and wont listen.

Now if the judge would see the film and read that article there might be a chance. How can that be accomplished?

One question though: Are judges allowed to accept perks from anyone? Because if they are you can bet BT and BP have done that and we're screwed.

 

[Sugar_and_Spice]

Great article. Too bad the powers to be who are making the rules wont care and wont listen.

Now if the judge would see the film and read that article there might be a chance. How can that be accomplished?

One question though: Are judges allowed to accept perks from anyone? Because if they are you can bet BT and BP have done that and we're screwed.

As a general rule of thumb no they are not.

 

[Bea-FL]

As a general rule of thumb no they are not.

Did anyone request for the judge to watch this film, and read the positive articles, the report from the Royal physicians, etc?

 

[retired1]

Did anyone request for the judge to watch this film, and read the positive articles, the report from the Royal physicians, etc?

The judge should be ignoring everything coming in that's not associated directly with the parties in the case.

 

[Bea-FL]

The judge should be ignoring everything coming in that's not associated directly with the parties in the case.

But why? This whole case has put vaping on trial. How csn she make an informed decision without bring informed about what vaping is and what it does?