Deeming Regulations have been released!!!!

[Vapeon4Life]

From the Motion to Stay...

C The Order Contradicts FDA’s Stated Reasoning

The Order Contradicts FDA’s Stated Reasoning
FDA’s Order also violates the cardinal APA rule that the agency’s
rationale must actually support its decision. Motor Vehicle Mfrs. ...’n of U.S.,

---

Seems like if you look up a the Arbitrary-or-Capricious Test for the Administrative Procedure Act (APA) in a Law Dictionary, the above text could be used as a Classic Example.

https://www.foreffectivegov.org/node/2625

What I ask is why have a PMTA process when in fact there was no intention of approving. In fact can it be proven that the FDA was in the process of making 90%, if not more, of the vaping industry illegal - and that the PMTA proces was a smoke screen to hide the agenda of doing the bidding of certain special interest groups with a prohibitionist agenda that could care less about 'harm reduction' especially when it comes to vaping products ???

 

[thanswr1]

What I ask is why have a PMTA process when in fact there was no intention of approving. In fact can it be proven that the FDA was in the process of making 90%, if not more, of the vaping industry illegal - and that the PMTA proces was a smoke screen to hide the agenda of doing the bidding of certain special interest groups with a prohibitionist agenda that could care less about 'harm reduction' especially when it comes to vaping products ???

I think the FDA's actions speak for themselves. They couldn't prove harm because there wasn't any. Then the goal post moved to "prove teenagers weren't attracted to vaping". The CDC shot that one out of the saddle.

So what does the FDA have left? Apparently, all they're left with is the appearance they had no idea what they were getting into. They just did it.

Courts are a crap shoot on the best of days. But this will be interesting.

A word of advice: Go long on popcorn futures.

 

[CMD-Ky]

Well there certainly seems there's not enough people in government with this attitude to help us vapers but I got a positive reply from my senator when I wrote asking him to oppose the tobacco tax.

This sentence from his reply really stood out to me.

" In addition, this tax would disproportionately affect nicotine products that have no tobacco content, such as e-cigarettes and nicotine pouches"

Toomey or Casey?

 

[zoiDman]

What I ask is why have a PMTA process when in fact there was no intention of approving[?]

Hello?

That was/is the Purpose of the FSTCA. It was to Keep New Tobacco Products Out of the Market. Because Tobacco Products were seen as a Major Cause of Preventable Deaths in the USA. So why do we Need More?

Unfortunately, e-Cigarettes got Swept Up into the FSTCA because the FDA wanted to Ban them as Drug Delivery Devices. So we argued that e-Cigarettes was the "Recreational Use of Nicotine". And Judge Leon agreed. And told the FDA to Off.

But Judge Leon also told the FDA that they could Regulate them. That is, if they "Deemed" them to be a "Tobacco Product".

So the FDA did. And Now here we are Today watching the FDA decides Who Wins and Who Looses based on God Knows what? But it sure Isn't Science. And Using the FSTCA act as authority to do so.

Something the FSTCA was Never Intended to do.

 

[Vapeon4Life]

So what does the FDA have left? Apparently, all they're left with is the appearance they had no idea what they were getting into. They just did it.

Courts are a crap shoot on the best of days. But this will be interesting.

A word of advice: Go long on popcorn futures.

And they hesitated - Remember, if it wasn't because of the lawsuits by the anti-vape cartels, they weren't going to rule until next year.

Now that some companies are in fact fighting back with their own lawsuits - The question is will this prevent actual enforcement {ie. legal acitons such as confiscations of inventory and/or financial assets} while the various legal actions play out in court ???

 

[SlowTalker]

The thing that stands out to me in all this mess is that vape products are required to be labeled as containing nicotine, even if they don't, and that nicotine is an addictive substance. Compare that to the Surgeon Generals warning on tobacco products. The same level of health warnings aren't made for nicotine because they haven't been established. Scare tactics as a basis for making law? Hopefully these lawsuits will result in the right questions being asked.

 

[Rossum]

The thing that stands out to me in all this mess is that vape products are required to be labeled as containing nicotine, even if they don't

War is Peace.
Freedom is Slavery.
Ignorance is Strenth.
This product contains Nicotine.

Seriously, I have often wondered (sometimes out loud) how a regulation that requires a vendor to make a patently false statement can possibly be upheld as valid.

Sorry, that atty does not contain any nicotine in its pristine, as-sold condition.

 

[Vapeon4Life]

War is Peace.
Freedom is Slavery.
Ignorance is Strenth.
This product contains Nicotine.

Seriously, I have often wondered (sometimes out loud) how a regulation can require a vendor to make a patently false statement can possibly be upheld as valid.

Sorry, that atty does not contain any nicotine in its pristine, as-sold condition.

Yes, welcome to the "1984" world of:
Doublethink - "George Orwell coined the term doublethink (as part of the fictional language of Newspeak) in his 1949 dystopian novel Nineteen Eighty-Four......."

Seems to me the PMTA process was the first shot in their campaign to bankrupt and/or otherwise destroy the vaping industry - It had little, if anything to do with protecting public health. And was agenda driven by bought and paid for special interests to deny and outlaw most vaping
products.

I'm busy binge watching an interesting TV series "SUITS" about big time lawyers in NYC.
Makes me wish I was a lawyer - It would be my pleasure to take on the FDA {et al} pro bono !!!

 

[BillW50]

You can't say your oranges cures scurvy either. Even though it has been well known for centuries. To be lawful, you must lie!

 

[Vapeon4Life]

"“The Philippine Senate will be on the right side of the people when it approves the most progressive vaping legislation in Asia Pacific,” says Nancy Loucas, Executive Coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).

Her comments follow the release of a survey conducted by ACORN Marketing & Research Consultants. ‘A Survey of Attitudes Among Adult Tobacco & Nicotine Users in the Philippines’ was commissioned by consumer advocacy group, Vapers PH.

Results confirm wide public support for a Tobacco Harm Reduction (THR) approach, using less harmful alternatives to combustible cigarettes such as e-cigarettes, HTPs and other smoke-free products.

The survey revealed a staggering 94% of respondents agree that the Government should enact policies to encourage adult smokers to switch to less harmful alternatives to cigarettes..........."

Philippine Survey Confirms Huge Support For Vaping | Scoop News

 

[thanswr1]

The thing that stands out to me in all this mess is that vape products are required to be labeled as containing nicotine, even if they don't, and that nicotine is an addictive substance. Compare that to the Surgeon Generals warning on tobacco products. The same level of health warnings aren't made for nicotine because they haven't been established. Scare tactics as a basis for making law? Hopefully these lawsuits will result in the right questions being asked.

You buy a coil or tank or mod and what do you see. You see a label a saying "this product contains nicotine".

Ahhh, no. They usually contain metal, or cotton, but no nicotine.

The entire FDA requirements didn't get anymore ridiculous than that.

This is why I believe this game hasn't even started to be played out.

 

[englishmick]

"“The Philippine Senate will be on the right side of the people when it approves the most progressive vaping legislation in Asia Pacific,” says Nancy Loucas, Executive Coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).

Her comments follow the release of a survey conducted by ACORN Marketing & Research Consultants. ‘A Survey of Attitudes Among Adult Tobacco & Nicotine Users in the Philippines’ was commissioned by consumer advocacy group, Vapers PH.

Results confirm wide public support for a Tobacco Harm Reduction (THR) approach, using less harmful alternatives to combustible cigarettes such as e-cigarettes, HTPs and other smoke-free products.

The survey revealed a staggering 94% of respondents agree that the Government should enact policies to encourage adult smokers to switch to less harmful alternatives to cigarettes..........."

Philippine Survey Confirms Huge Support For Vaping | Scoop News

Well that is interesting. Interesting that a country which has a somewhat shaky record of democracy would listen to what their citizens think about the issue, rather than what benefits the government's bank balance. It's also interesting that the population thinks that way. I suspect the same survey in the US would come up with a very different result. People in the US, as well as a lot of other countries, have been fed propaganda about the evils of vaping by corporate/political players and swallowed it whole. Why are we so ready to accept the nonsense we are fed, on this as well as so many other issues?

 

[Vapeon4Life]

Well that is interesting. Interesting that a country which has a somewhat shaky record of democracy would listen to what their citizens think about the issue, rather than what benefits the government's bank balance. It's also interesting that the population thinks that way. I suspect the same survey in the US would come up with a very different result. People in the US, as well as a lot of other countries, have been fed propaganda about the evils of vaping by corporate/political players and swallowed it whole. Why are we so ready to accept the nonsense we are fed, on this as well as so many other issues?

I've been following the Philippine situation for months - First they openly fingered Blumborg {sic} and his so called philanthropies attempts to illegally interfere with their politics to further his anti vape agenda.
Apparently people {especially politicians} in this country {USA} are so bought and paid for by blumborg's {sic} money that it is either going under the radar or being buried. [I've been making this point on another major vaping forum and received very high plus feedback accordingly - Next thing you know I was blocked from posting there!!!] - blumborg's corrupting money at work!!!.

In the '90s we were able to block the FDA and bought and paid for politicians from regulating vitamins and supplements out of the free market by a massive petition drive that caused congress to pass legislation guaranteeing our right to purchase most vitamins and supplements freely on the open market - But maybe 50% or more of the country was using some form of dietary supplement - With vaping we don't have enough numbers. So I keep harping on the corrupt nature of the special interests that are trying to deny a harm reduction product to tobacco users - And keep praying that the rest of the country will realize that it will never stop with just tobacco products {blumborg {sic} was trying to limit the size of soft drinks, but was overturned by court action} - Hopefully, and accordingly court action will also stop the vape prohibitionists!

 

[MikeE3]

Toomey or Casey?

Toomey ... you had to ask? Casey is worthless.

 

[WorksForMe]

Well, this could get interesting.

More Vape Manufacturers Challenge PMTA Denials

"On Sept. 29, Florida-based Bidi Vapor, which makes prefilled disposable vape devices, petitioned the 11th U.S. Circuit Court of Appeals to review the FDA’s MDO for 11 flavors of its BIDI Stick product. In a press release, the company says it submitted more than 285,000 pages of material supporting its Premarket Tobacco Applications (PMTAs).
Bidi Vapor is asking the court to vacate the FDA marketing denial because it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law, as well as contrary to constitutional right and in excess of statutory jurisdiction, authority, or limitations, or short of statutory right.”

"Buffalo, NY-based Magellan Technology, which sells the pod-based Juno device and also owns major vaping product distributor DemandVape, has appealed its MDO for multiple prefilled pods sold under the Juno brand. Magellan’s PMTA was handled by AVAIL Vapor subsidiary Blackbriar Regulatory Services.
Among other arguments, the Magellan petition, filed Sept. 24 in the 2nd Circuit Court of Appeals, claims the newly asserted FDA demand for a different and higher standard of evidence in PMTAs for flavored products than for tobacco- and menthol-flavored products amounts to the illegal creation of a new product standard. The FDA announced the new de facto standard on Aug. 26, along with the first MDOs issued to manufacturers of flavored vaping products."

.

 

[Katya]

Well, this could get interesting.

All we need now is another Judge Leon.

 

[englishmick]

At the least (hopefully) they will be forced to explain their reasons for the rejections, and how they were based on the Deeming regs. And do it in a public forum. If their explanation is shaky enough maybe there will be some pushback from the judge.

 

[WorksForMe]

Well, this could get interesting.

One sentence I forgot to quote from the vaping360 article.

"Several more companies are expected to file their own lawsuits soon."

.

 

[WorksForMe]

 

[Rossum]

"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!