Deeming Regulations have been released!!!!

[WorksForMe]

Another lawsuit filed. This one by e-liquid manufacturer Triton Distribution.

"Black-letter rules of administrative law prevent an agency from retroactively changing legal requirements and from doing so without accounting for reliance interests. FDA failed to satisfy these requirements when it executed an about-face on the evidence [required for PMTAs]."

"Triton has been irreparably harmed as a result and faces an imminent shutdown of its business in approximately two weeks. Thus, Triton respectfully requests that the Court enter an emergency stay of FDA’s MDO for Triton’s products by October 15, 2021, and order expedited merits briefing."

"Triton later learned, through FDA’s response to its [FOIA] request, that FDA’s 'scientific review' apparently consisted of only two 'check-the-box' forms—each of which was only three pages long."

.

 

[Katya]

Keep 'em coming!

 

[Vapeon4Life]

Keep 'em coming!

Now maybe I'm being overly optimistic - But this just occurred to me - Maybe, just maybe, the FDA and others agencies of government {like USPS} want just that? - They, at least some, don't really want to enforce unpopular rules and regulations that are agenda driven by people and groups that are trying to force them to do things they really don't want to do !
Like the USPS, and this partially because of lost revenue - Does not really want to stop vape sales through the mail. And you will notice the half-assed way the FDA justified its massive draconian denials - by admitting that vaping may be safer for adults and then saying but underage will still get there hands on it {flavored e juice}.
Duh?!?! By that justification they would have to outlaw all tobacco products and of course what about alcoholic drinks and of flavored alcohol products? - I don't think this will stand up in court - And like in the same way that the PMTA wasn't supposed to go into effect until 2022 but anti vape cartels forced it ahead of time by legal action - And are unhappy with the FDAs ruling, and should be because it almost seems to be designed to be overturned in court!
Am I being overly optimistic or is this possible ???

 

[CMD-Ky]

"It is an insult to the American public..."

Not at all. They are highly educated public health experts, who know what's best for the American public. Now quit or die, you dirty nicotine addict!

Sarcasm noted and wildly approved of. I have listened to and read a great deal of what our public health experts have said or written on many health issues. I have concluded that we have no public health experts.

 

[Rossum]

I have listened to and read a great deal of what our public health experts have said or written on many health issues. I have concluded that we have no public health experts.

Yeah, one might almost think that they are more interested in the financial health of their corporate patrons than the public health.

Corporate patrons? Yes. Here on Youtube is a 12-1/2 minute explanation of the problem by a guy (Russel Brand), who I don't often see eye-to-eye with. It doesn't directly address the predicament that the vaping industry currently finds itself in, but I think the parallels should be obvious.

 

[CMD-Ky]

Yeah, one might almost think that they are more interested in the financial health of their corporate patrons than the public health.

Corporate patrons? Yes. Here on Youtube is a 12-1/2 minute explanation of the problem by a guy (Russel Brand), who I don't often see eye-to-eye with. It doesn't directly address the predicament that the vaping industry currently finds itself in, but I think the parallels should be obvious.

I would love to see Lord Fachi's stock portfolio from the AZT days in the '80's through the vaccine's of '20-'21. Just an inquiring mind.

 

[Rossum]

I would love to see Lord Fachi's stock portfolio from the AZT days in the '80's through the vaccine's of '20-'21. Just an inquiring mind.

I imagine if he was in charge of tobacco control policies, Chantix would be the only approved quitting aid, and it might very well be mandatory to take it if a person hadn't quit by a particular date.

 

[Bronze]

I imagine if he was in charge of tobacco control policies, Chantix would be the only approved quitting aid, and it might very well be mandatory to take it if a person hadn't quit by a particular date.

And kids 5-11 years old would be on it.

 

[CMD-Ky]

And kids 5-11 years old would be on it.

Preventative care

 

[Vapeon4Life]

I imagine if he was in charge of tobacco control policies, Chantix would be the only approved quitting aid, and it might very well be mandatory to take it if a person hadn't quit by a particular date.

Chantix???......

Pfizer Recalls Anti-Smoking Drug Chantix Over Cancer Concerns: What to Know........

"Pfizer is recalling its anti-smoking drug Chantix after the Food and Drug Administration (FDA) reportedTrusted Source that long-term use of the medication can lead to an increased risk of cancer........."

Smoking Drug Chantix Recalled Over Cancer Concerns

Now that we know that one of their stop smoking drugs puts you at risk for cancer any sensible person might ask why don't they promote vaping? - The pharmaceutical industry has a lot more money than the vaping industry that's why!

Remember the old saying:
"Don't get angry - Sue the .......s" !

And so the vaping industry is doing just that.

 

[WorksForMe]

And the plot thickens...

Turning Point Brands' PMTAs Are Back Under FDA Review

"On Friday, Turning Point Brands, which late last month petitioned a federal court to review a marketing denial order for many of its vapor products, is withdrawing its appeal. The company is doing so because, on Thursday, the Food and Drug Administration informed TPB the products that had been denied are now back under review."


.

 

[zoiDman]

And the plot thickens...

Turning Point Brands' PMTAs Are Back Under FDA Review

"On Friday, Turning Point Brands, which late last month petitioned a federal court to review a marketing denial order for many of its vapor products, is withdrawing its appeal. The company is doing so because, on Thursday, the Food and Drug Administration informed TPB the products that had been denied are now back under review."


.

Oh FFS. Wax On Wax Off.

The FDA is a (Scientific) Joke. And one of the Few agencies that can make the WHO look like a Professional Organization.

So Only the People who can Afford to Sue can be Considered? Surprised that the FDA didn't require last years Schedule C to be included with each PMTA.

 

[WorksForMe]

So Only the People who can Afford to Sue can be Considered?

Maybe only companies that sue and included the studies that the FDA wanted will be included. The FDA doesn't want to regulate anymore companies than they absolutely have to.

From FDA's letter to TPB:
“Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”

 

[zoiDman]

Maybe only companies that sue and included the studies that the FDA wanted will be included. The FDA doesn't want to regulate anymore companies than they absolutely have to.

From FDA's letter to TPB:
“Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”

Hard to say what will Satisfy the FDA? They seem to have No Problem pulling New "Standards" out of their hats and Higher Bars to Jump Over at the 11th Hour. They Also would Not have Caved so quickly unless they knew that they were going to get Smack Down in Federal Court.

But you are Right. The FDA wants to have the Number of US e-Cigarette OEM's countable on One Hand.

BTW - Somewhere Dick Durbin (as well as a Few others) is having a Hissy Fit.

 

[Rossum]

"On Friday, Turning Point Brands, which late last month petitioned a federal court to review a marketing denial order for many of its vapor products, is withdrawing its appeal. The company is doing so because, on Thursday, the Food and Drug Administration informed TPB the products that had been denied are now back under review."

Oh FFS. Wax On Wax Off.

What you see here is not an uncommon tactic when a government or agency thereof engages in overreach and someone with the means to challenge them in court does so. When this happens, the government will change its tune in that particular case in order to avoid being found in the wrong and having a legal precedent set that invalidates their position entirely.

 

[Katya]

What you see here is not an uncommon tactic when a government or agency thereof engages in overreach and someone with the means to challenge them in court does so. When this happens, the government will change its tune in that particular case in order to avoid being found in the wrong and having a legal precedent set that invalidates their position entirely.

"The only thing necessary for the triumph of evil is that good men should do nothing."

We've been playing this cat and mouse game with FDA for 11 years now. The problem is, we're dealing with the most political FDA in history--or so it seems.

 

[DaveOno]

I think I have a case.

I recently purchased a box of Aspire Nautilus coils. It has a very conspicuous label saying
"This product contains nicotine which is a highly addictive substance."

I looked and looked, but I didn't get any nicotine. Just some metal, the kanthal coil, a few rubber seals, and the cotton or rayon, but it is dry.

Where's the promised nicotine? Can they say it does, when everyone knows it doesn't?

Do I file suit against Aspire? Or the agency that mandated this false label?



(btw, my "Duck Sauce doesn't have any duck" lawsuit isn't going too good...)

 

[Vapeon4Life]

I think I have a case.

I recently purchased a box of Aspire Nautilus coils. It has a very conspicuous label saying
"This product contains nicotine which is a highly addictive substance."

I looked and looked, but I didn't get any nicotine. Just some metal, the kanthal coil, a few rubber seals, and the cotton or rayon, but it is dry.

Where's the promised nicotine? Can they say it does, when everyone knows it doesn't?

Do I file suit against Aspire? Or the agency that mandated this false label?



(btw, my "Duck Sauce doesn't have any duck" lawsuit isn't going too good...)

No one knows exactly how all this is going to play out - But if the FDA has regulations that are requiring companies to lie by saying hardware contains nicotine when of course it doesn't and vaping hardware can be, and often is used to vape products that have no nicotine - Any smart lawyer can make the FDA look disingenuous, if nothing else.
Also, can a bunch of challenging lawsuits by manufacturers tie up the vapopaclyplse for at least a few more years, if not stopping it completely ???

 

[UncLeJunkLe]

Do I file suit against Aspire? Or the agency that mandated this false label?

Both. It's false advertising by aspire, forced by the mafia known as the FDA.

 

[DaveOno]

Thanks for all your likes (or funny's).

But I'm sorta wondering. Can't there be a class action case against the FDA for the intentional mislabeling? There's no case against the manufacturer, as they are forced to place the label.

So, what is my standing? Upset because I didn't get any nicotine? Can the suit stand just because I (or we) was (or were) intentionally mislead?

Or will this lead to labels on Red Bull and Mt. Dew saying "This product contains caffeine which is a highly addictive substance." Then going to all soft drinks, even the caffeine-free ones?

And then will they raid my house, inspecting every mattress and pillow that I removed the label that says "Do not remove this label?"

And if I misspoke, would their counter-suit be label libel?