Deeming Regulations have been released!!!!

[zoiDman]

And that is one of the many problems

Bottom line is this, I have been very sceptical and remain very sceptical that anything positive will happen. My belief is we're all going to get screwed, thus the need to establish a healthy and respectable stockpile.

I really think that things Will Get Better.

Because I think that the Overreach of "Intended Use" will be thrown out. And I am even Optimistic that the Predicate Date will be Pushed Up. Maybe not to 21 Months from Enactment of the Deeming, but Substantially Changed.

And I believe that the PMTA process will be Revised. Once again, how much? Dunno.

But there is One Thing that I do Not See changing. And that is the FDA's Authority to Regulate e-liquids that contain Nicotine derived from tobacco. I Think that is going to be with us for good.

 

[Bronze]

I really think that things Will Get Better.

Because I think that the Overreach of "Intended Use" will be thrown out. And I am even Optimistic that the Predicate Date will be Pushed Up. Maybe not to 21 Months from Enactment of the Deeming, but Substantially Changed.

And I believe that the PMTA process will be Revised. Once again, how much? Dunno.

But there is One Thing that I do Not See changing. And that is the FDA's Authority to Regulate e-Liquids that contain Nicotine derived from Tobacco. I Think that is going to be with us for good.

Agree with all. Will believe it when I see it but if I had to make a prediction I would go with yours.

 

[Lessifer]

And I believe that the PMTA process will be Revised. Once again, how much? Dunno.

This is the kicker, and is most of the basis for wanting vaping removed from tobacco regulation. There are others, like insurance surcharges.

Moving the predicate date would allow the industry to survive, somewhat, but it would still be stagnant. If the approval process can be redefined within the limits of tobacco control, to a point where it won't slowly choke the industry to death, good. I don't know how optimistic I am about that though, since no one with any power has ever mentioned it.

 

[zoiDman]

This is the kicker, and is most of the basis for wanting vaping removed from tobacco regulation. There are others, like insurance surcharges.

Moving the predicate date would allow the industry to survive, somewhat, but it would still be stagnant. If the approval process can be redefined within the limits of tobacco control, to a point where it won't slowly choke the industry to death, good. I don't know how optimistic I am about that though, since no one with any power has ever mentioned it.

A New HHS Secretary/FDA Commissionaire has a Tremendous Amount of Power to change the Landscape of e-Cigarettes/e-Liquids. And they Don't Need Congress or the Courts to do so.

Why couldn't a new FDA Commissionaire write a New PMTA process for e-Cigarettes/e-Liquids? One that Promoted Harm Reduction and Innovation verses Stifling it?

Moving the Predicate Date is Huge. But if a Reasonable PMTA process was in place, would Moving it be as Important?

 

[CMD-Ky]

And people still wonder why I consider myself a philsophical anarchist.

Now that is a wonder that never crossed my mind.

 

[beckdg]

Thus why it needs to go up the the Supreme Court if it has to.

I hope you have a lot of pennies.

I'm fittin' to fix me up a grand ole wishing well.

Tapatyped

 

[r055co]

I hope you have a lot of pennies.

I'm fittin' to fix me up a grand ole wishing well.

Tapatyped

Nope, I just have a large FDA Apocalypse Stockpile

 

[beckdg]

Nope, I just have a large FDA Apocalypse Stockpile

Tapatyped

 

[MacTechVpr]

This is the kicker, and is most of the basis for wanting vaping removed from tobacco regulation. There are others, like insurance surcharges.

Moving the predicate date would allow the industry to survive, somewhat, but it would still be stagnant. If the approval process can be redefined within the limits of tobacco control, to a point where it won't slowly choke the industry to death, good. I don't know how optimistic I am about that though, since no one with any power has ever mentioned it.

Don't go bettin' on that horse Less. Now you've gone and really changed the odds.

If this were a rational reconsideration of the legislation, we would all be discussing eradicating the underlying misconstructions in law. Not the mediation of resulting [harm brought by] present regulations or how plausible or impossible that might be to accomplish. The latter is one sad bet.

Good luck.

 

[Shawn Hoefer]

This is the kicker, and is most of the basis for wanting vaping removed from tobacco regulation. There are others, like insurance surcharges.

Moving the predicate date would allow the industry to survive, somewhat, but it would still be stagnant. If the approval process can be redefined within the limits of tobacco control, to a point where it won't slowly choke the industry to death, good. I don't know how optimistic I am about that though, since no one with any power has ever mentioned it.

Ah.... but moving the predicate date would allow for a lot of devices to be pushed through using the much easier Significant Equivalencies application. The market would not stagnate, but would move at, perhaps, a saner pace...

Sent from my SAMSUNG-SM-N910A using Tapatalk

 

[Max-83]

A New HHS Secretary/FDA Commissionaire has a Tremendous Amount of Power to change the Landscape of e-Cigarettes/e-Liquids. And they Don't Need Congress or the Courts to do so.

Why couldn't a new FDA Commissionaire write a New PMTA process for e-Cigarettes/e-Liquids? One that Promoted Harm Reduction and Innovation verses Stifling it?

Not sure that would be a permanent solution Zoid. A re-interpretation or new ruling from a new FDA commissionaire is pretty much like an executive order. It can be reversed by another incoming commissionaire.

The permanent solution is probably first, un-reversible decision from the court (would need to be supreme court?). Or, legislation from congress (which can be reversed anytime by another piece of legislation, tho unlikely).

 

[Lessifer]

Ah.... but moving the predicate date would allow for a lot of devices to be pushed through using the much easier Significant Equivalencies application. The market would not stagnate, but would move at, perhaps, a saner pace...

Sent from my SAMSUNG-SM-N910A using Tapatalk

From everything I've read, substantial equivalence is not easy, and it doesn't allow for improvement. That's the point. Substantially EQUIVALENT, meaning only minor changes that do not effect the product or the experience of the product.

It would make more sense if the TCA weren't written with the express intention of keeping new products off the market. They're supposed to allow for improvements that make products safer, but the standard of proof for that designation is, so far, unreachable.

@zoiDman Here is the problem, and I'm not sure I'm right, but it's the way I see it. The TCA is more about smoking/tobacco use prevention/discouragement, than it is about making tobacco products safer. As long as vapor products are considered tobacco products, even getting every smoker to switch would not be an improvement in the eyes of the ideologues, as they would all still be tobacco users.

 

[Shawn Hoefer]

From everything I've read, substantial equivalence is not easy, and it doesn't allow for improvement. That's the point. Substantially EQUIVALENT, meaning only minor changes that do not effect the product or the experience of the product.

It would make more sense if the TCA weren't written with the express intention of keeping new products off the market. They're supposed to allow for improvements that make products safer, but the standard of proof for that designation is, so far, unreachable.

@zoiDman Here is the problem, and I'm not sure I'm right, but it's the way I see it. The TCA is more about smoking/tobacco use prevention/discouragement, than it is about making tobacco products safer. As long as vapor products are considered tobacco products, even getting every smoker to switch would not be an improvement in the eyes of the ideologues, as they would all still be tobacco users.

Easier than a PMTA... just sayin'

Sent from my SAMSUNG-SM-N910A using Tapatalk

 

[Katya]

From everything I've read, substantial equivalence is not easy, and it doesn't allow for improvement. That's the point. Substantially EQUIVALENT, meaning only minor changes that do not effect the product or the experience of the product.

Right, but, at least on paper, it would be much easier to argue that a fillerless tank is SE to another fillerless tank than to submit a brand new and extremely costly and complex PMTA for every single item that is has been on the market since 2007...

 

[zoiDman]

...

The permanent solution is probably first, un-reversible decision from the court (would need to be supreme court?). Or, legislation from congress (which can be reversed anytime by another piece of legislation, tho unlikely).

A Court Ruling would be Great. Just No Guarantee that we will get one. And Appeals can take a Long Time. With, again, No Guarantees.

And as you mentioned, another piece of Legislation overturning previous Legislation might be Unlikely. That thought Applies to the Legislation you suggest as the Solution... Right?

I think our chances of Successes is Maximized the More Fronts we approach on this.

Push for the Cole-Bishop Legislation. And Push for a Revamping of FDA Policy via the HHS Sec/FDA Commissionaire. Because that is what is in front of us Know.

 

[zoiDman]

...

@zoiDman Here is the problem, and I'm not sure I'm right, but it's the way I see it. The TCA is more about smoking/tobacco use prevention/discouragement, than it is about making tobacco products safer. As long as vapor products are considered tobacco products, even getting every smoker to switch would not be an improvement in the eyes of the ideologues, as they would all still be tobacco users.

Don't want to sound like a Debbie Downer. But e-Liquids that contain Nicotine derived from Tobacco may Always be considered a Tobacco Product in the US regulatory scheme.

But that isn't to Say that they need to go down the Same Regulatory Road as Combustible Tobacco. Times can Change when the People making the Policies Change.

And Good or Bad, this Administration is doing one thing. Making Changes.

 

[Lessifer]

Don't want to sound like a Debbie Downer. But e-Liquids that contain Nicotine derived from Tobacco may Always be considered a Tobacco Product in the US regulatory scheme.

But that isn't to Say that they need to go down the Same Regulatory Road as Combustible Tobacco. Times can Change when the People making the Policies Change.

And Good or Bad, this Administration is doing one thing. Making Changes.

They MAY always be considered a Tobacco Product, or maybe someday they'll have a classification that exempts them similar to the way NRT is exempted from the TCA, since it is part of a separate regulatory scheme. Not that I think we should go down the drug/drug device path, just pointing out that there can be exemptions if a class of products belongs under different regulations, even though all of the nicotine comes from tobacco.

 

[Eskie]

They MAY always be considered a Tobacco Product, or maybe someday they'll have a classification that exempts them similar to the way NRT is exempted from the TCA, since it is part of a separate regulatory scheme. Not that I think we should go down the drug/drug device path, just pointing out that there can be exemptions if a class of products belongs under different regulations, even though all of the nicotine comes from tobacco.

There is a bit of wiggle room in the TCA for a rational regulation of these things as a modified risk tobacco product as more objective studies are released indicating the long term safety in comparison to cigarettes and reduction in overall smoking rates. This is easier than a drug approval for an NRT, and allow evidence based findings across product classes. If a 12 mg juice is approved, a 6 or 3 mg juice should not require any additional work other than using the same approved substances and complying with the same GMP as the initial product. Mods, or batteries depending how you want to refer to them, should also be able to rely on circuit designs that provide equivalent power already approved. Maybe we can even finally get a standardized 510 out of it (I know, I'm dreaming rainbows now).

All that is possible within the rule making powers already granted to the FDA. In a perfect world filled with rational people making informed decisions, there would be no need for additional legislation or lawsuits. Unfortunately, this is not a perfect world, and the folks in position for drafting and enforcing these rules have no interest in making rational informed decisions that improve the public health of this country.

 

[Lessifer]

There is a bit of wiggle room in the TCA for a rational regulation of these things as a modified risk tobacco product as more objective studies are released indicating the long term safety in comparison to cigarettes and reduction in overall smoking rates. This is easier than a drug approval for an NRT, and allow evidence based findings across product classes. If a 12 mg juice is approved, a 6 or 3 mg juice should not require any additional work other than using the same approved substances and complying with the same GMP as the initial product. Mods, or batteries depending how you want to refer to them, should also be able to rely on circuit designs that provide equivalent power already approved. Maybe we can even finally get a standardized 510 out of it (I know, I'm dreaming rainbows now).

All that is possible within the rule making powers already granted to the FDA. In a perfect world filled with rational people making informed decisions, there would be no need for additional legislation or lawsuits. Unfortunately, this is not a perfect world, and the folks in position for drafting and enforcing these rules have no interest in making rational informed decisions that improve the public health of this country.

You're right, if the FDA took a wildly different interpretation of MRTP than they have in the past, it could be possible within the current regulations.

 

[Eskie]

You're right, if the FDA took a wildly different interpretation of MRTP than they have in the past, it could be possible within the current regulations.

Now it should be about the reasonable interpretation of the legislation they were given. And the legislation does recognize a benefit from a MRTP that decrease cigarette use and improves public health. Whether they can be compelled to reconsider the current interpretation remains to be seen. It's a mater of how motivated the head of the Tobacco Institute and the Commissioner of the FDA are to doing what's appropriate to the mission given by the TCA, decreasing harm from tobacco.