Deeming Regulations have been released!!!!

[440BB]

That clears it up. What specific technology came after 2016 are they gunning for?

Any product that had not yet been marketed and/or sold by 8/8/16, even if it was just a revised version of an existing device.

If a newer device can be proven to be substantially equivalent to an approved device, a much cheaper approval process will be available in the future.

That's dependent on devices getting PMTA approval, so the post 8/8/16 products may have quite a delay.

 

[mikepetro]

That clears it up. What specific technology came after 2016 are they gunning for?

Pods, kids, flavors, kids, Juul....

 

[mikepetro]

After 28,000+ posts and 1400+pages it's easy for the basic deeming dates and rules to get lost in the shuffle.

Perhaps many got lulled into complacency and forgot that that cool new shiny from last couple years is not among things that can get PMTA approval.

Depending on the when and how of enforcement, many vapers are in for a big surprise.

Funny thing, I visited about 6 vape stores yesterday, getting some items for research, and I asked each one of them what they plan to do after Sept. 9th. Only 1 of the 6 even knew what I was talking about, and the 1 said they werent doing anything different because they didnt believe it would happen.

 

[Territoo]

Pods, kids, flavors, kids, Juul....

No, Juul came into being in 2015. They've filed a PMTA, probably the first to do so, and will continue to be sold. They are more likely to be approved than a box mod with a sub ohm tank. They've got the lobby money to make it happen.

 

[f1vefour]

Closed systems have the leg up on being approved from my understanding.

 

[zoiDman]

No, Juul came into being in 2015. They've filed a PMTA, probably the first to do so, and will continue to be sold. They are more likely to be approved than a box mod with a sub ohm tank. They've got the lobby money to make it happen.

I Hope that JUUL is the 1st realistic PMTA to be Denied.

JUUL/Altria could be the ones to bring a meaningful (and perhaps Enjoined) Lawsuit against the FDA for a Denied PMTA application.

Based on the Lack of Any Statutory Standards or Clear Guidance by the FDA. And Capricious actions of the CTP.

And if one subscribes to that Enemy of My Enemy thing, JUUL/Altria could be Our Best Friend going Forward.

 

[Katya]

Funny thing, I visited about 6 vape stores yesterday, getting some items for research, and I asked each one of them what they plan to do after Sept. 9th. Only 1 of the 6 even knew what I was talking about, and the 1 said they werent doing anything different because they didnt believe it would happen.

I don't believe you.

 

[Katya]

I Hope that JUUL is the 1st realistic PMTA to be Denied.

JUUL/Altria could be the ones to bring a meaningful (and perhaps Enjoined) Lawsuit against the FDA for a Denied PMTA application.

Based on the Lack of Any Statutory Standards or Clear Guidance by the FDA. And Capricious actions of the CTP.

And if one subscribes to that Enemy of My Enemy thing, JUUL/Altria could be Our Best Friend going Forward.

And here we go again. Sottera Inc. vs FDA.

 

[Territoo]

I Hope that JUUL is the 1st realistic PMTA to be Denied.

JUUL/Altria could be the ones to bring a meaningful (and perhaps Enjoined) Lawsuit against the FDA for a Denied PMTA application.

Based on the Lack of Any Statutory Standards or Clear Guidance by the FDA. And Capricious actions of the CTP.

And if one subscribes to that Enemy of My Enemy thing, JUUL/Altria could be Our Best Friend going Forward.

This harkens back to the Smoking Everywhere/Njoy v FDA days. None of the vapers used these products, but obviously stood by them against the FDA. I doubt we'll see a replay of those days. Most likely Juul gets approved, and if not they'll get some liberal judge, not a Judge Leon.

 

[zoiDman]

And here we go again. Sottera Inc. vs FDA.

Yeah... But could you Imagine if we got an Injunction (and later a Bench Ruling) say'n that No PMTA could be Denied because the FDA Failed to provide Any Type of Regulatory Standards needed for PMTA Completion.

And the FDA Needs to go back and Fulfill the Regulatory Obligation of telling Stakeholders what Is and what Isn't an Approvalable PMTA.

The FDA is going to be Sued over a Denied PMTA(s).

I'd just like it to be Someone like JUUL/Altria who has the Best of the Best when it comes to Bottom Dwelling Lawyers.

 

[Territoo]

Yeah... But could you Imagine if we got an Injunction (and later a Bench Ruling) say'n that No PMTA could be Denied because the FDA Failed to provide Any Type of Regulatory Standards needed for PMTA Completion.

And the FDA Needs to go back and Fulfill the Regulatory Obligation of telling Stakeholders what Is and what Isn't an Approvalable PMTA.

The FDA is going to be Sued over a Denied PMTA(s).

I'd just like it to be Someone like JUUL/Altria who has the Best of the Best when it comes to Bottom Dwelling Lawyers.

Call me pessimistic, but it's going to happen to some small company that took out a second mortgage on their home to file the PMTA.

 

[zoiDman]

This harkens back to the Smoking Everywhere/Njoy v FDA days. None of the vapers used these products, but obviously stood by them against the FDA. I doubt we'll see a replay of those days. Most likely Juul gets approved, and if not they'll get some liberal judge, not a Judge Leon.

It's Hard to Say. A Lot depends on Who is going to be running HHS and the FDA?

But No Matter Who is in charge, JUUL has got a Very Uphill Battle in front of them.

I mean, How Many other Companies have a Catch Phrase for Teen Vaping named after them?

 

[zoiDman]

Call me pessimistic, but it's going to happen to some small company that took out a second mortgage on their home to file the PMTA.

Not Pessimistic at all.

Because if you Bet your House on a PMTA, and expect the FDA to do what is Fair and Right, you will Probably get just what you Deserve.

 

[Katya]

Not Pessimistic at all.

Because if you Bet your House on a PMTA, and expect the FDA to do what is Fair and Right, you will Probably get just what you Deserve.

That's cold, Z.

Look at our state. First the adult signature on delivery, and now full-fledged flavor ban. How many good, hard-working people will lose their jobs and thus their ability to feed their family and pay their rent? In the middle of a global pandemic. Why?

 

[zoiDman]

That's cold, Z.

Look at our state. First the adult signature on delivery, and now full-fledged flavor ban. How many good, hard-working people will lose their jobs and thus their ability to feed their family and pay their rent? In the middle of global pandemic. Why?

Just say'n that the current FDA Couldn't Care Less if 30,000 or 40,000 People loose their Jobs over all this. Or that they Really think 400K People Dying from Smoking really Matters.

And I Don't think it is going to get better (Understatement of the Year) if the person sitting in the Oval Office changes.

You gotta remember, the FSTCA and the entire PMTA process was NEVER about helping New Tobacco Products to enter the Market. It was About Keeping New Tobacco Products Out of the Market.

If the FDA had Real Thoughts about THR, they would have formed an Division for the Evaluation of e-Cigarettes. Instead of just Smashing the Square Peg in the Round Hole of Zeller's CTP

 

[mikepetro]

This harkens back to the Smoking Everywhere/Njoy v FDA days. None of the vapers used these products, but obviously stood by them against the FDA. I doubt we'll see a replay of those days. Most likely Juul gets approved, and if not they'll get some liberal judge, not a Judge Leon.

Dont underestimate the "save the children" factor to influence politics.

 

[BillW50]

No, Juul came into being in 2015. They've filed a PMTA, probably the first to do so, and will continue to be sold. They are more likely to be approved than a box mod with a sub ohm tank. They've got the lobby money to make it happen.

I couldn't believe it since I thought it was much later. Then I searched and found PAX Labs/JUUL as early as 2017. But then I did a WayBackMachine search for JUUL.com and nothing but a blogger owned juul.com back then. But then I stumbled on juulvapor.com captured by the WayBackMachine on June 19, 2015.

https://web.archive.org/web/20150619055948/https://www.juulvapor.com/

 

[Territoo]

Dont underestimate the "save the children" factor to influence politics.

True, but don't under estimate the dollar factor either.

 

[Katya]

I couldn't believe it since I thought it was much later. Then I searched and found PAX Labs/JUUL as early as 2017. But then I did a WayBackMachine search for JUUL.com and nothing but a blogger owned juul.com back then. But then I stumbled on juulvapor.com captured by the WayBackMachine on June 19, 2015.

Introducing JUUL - Smoking Evolved

Introducing the Juul

 

[zoiDman]

Introducing the Juul

Is there Anything e-Cig-wise that the ECF doesn't have.