FDA TVECA post table of contents for Deeming Final Rule

[roxynoodle]

They would Contract a Firm to Conduct one for them.

They would have to to have any chance of it being acceptable. Roxy's Perception Study wouldn't cut it, I'm afraid.

 

[Katya]

They would Contract a Firm to Conduct one for them.

Right.

Or they could conduct an "Internet-based" study like Prue Talbot does. Hey, even the NYT quotes her all the time.

Study (Abstract and Conclusion): 100% of ECF users have a very good perception of vaping. They all think it's cool. End of study!

 

[zoiDman]

What makes you think they actually WANT them to? That's the point, that's why this leads to decimation.

It's not just about the cost of doing these things, it's about having the ability to do them. The tobacco companies have been doing PMTA for a long time, they have specialists on staff. Your local B&M, or your favorite online vendor, or mod maker, is totally outmatched.

And I think this is Why we are Seeing such Apathy from B&M and Online Retailers when it comes to Advocacy. Or to Informing their Customer Base of what is going on.

 

[Katya]

What makes you think they actually WANT them to?

Nothing. They obviously don't because it's clearly impossible for a small business owner to meet their requirements.

That's the point, that's why this leads to decimation.

Not decimation. Decimation means "removal of a tenth." Decimation would be very nice.

What they want is annihilation of vaping.

 

[Lessifer]

Right.

Or they could conduct an "Internet-based" study like Prue Talbot does. Hey, even the NYT quotes her all the time.

Study (Abstract and Conclusion): 100% of ECF users have a very good perception of vaping. They all think it's cool. End of study!

That wouldn't be good. That would show that vapor products are likely to entice someone to switch to them from smoking, and continue using them after they stop smoking, out of a perception that vapor products are less harmful than smoking. All of that would lead to a rejection of the PMTA since the purpose of the FSPTCA is to get people to stop using tobacco products.

 

[roxynoodle]

Right.

Or they could conduct an "Internet-based" study like Prue Talbot does. Hey, even the NYT quotes her all the time.

Study (Abstract and Conclusion): 100% of ECF users have a very good perception of vaping. They all think it's cool. End of study!

Exactly what I was thinking. Ask only those whose answers I expect to be favorable

 

[zoiDman]

They would have to to have any chance of it being acceptable. Roxy's Perception Study wouldn't cut it, I'm afraid.

Right.

Or they could conduct an "Internet-based" study like Prue Talbot does. Hey, even the NYT quotes her all the time.

Study (abstract and Conclusion): 100% of ECF users have a very good perception of vaping. They all think it's cool. End of study!

Yeah... If you have Never seen some of the Regulatory Hoops that have to be Jumped Thru, it can be Hard to Believe.

I'm involved with a Company that has a Product Line of CRP Containers. You would think that something as Simple as the Color of the Plastic used Wouldn't be and Issue.

But it Is.

And Kids are Brought in by Independent Testing Firms to see what Colors they Like for a given Container. And those are the Colors that you Don't Want to use.

 

[Katya]

That wouldn't be good. That would show that vapor products are likely to entice someone to switch to them from smoking, and continue using them after they stop smoking, out of a perception that vapor products are less harmful than smoking. All of that would lead to a rejection of the PMTA since the purpose of the FSPTCA is to get people to stop using tobacco products.

 

[roxynoodle]

Seriously? I'm so sorry, Roxy...

Thank you, but its not an issue . I don't really care what he thinks of my thoughts or plans. And I don't need to participate in the thread. I bought the spare parts I wouldn't have been able to track down, so I'm good as long as the other parts that aren't replaceable hold up.

 

[zoiDman]

Nothing. They obviously don't because it's clearly impossible for a small business owner to meet their requirements.

...

One thing that I thought would happen was that Small e-Liquid Businesses would Band Together to share the Expense of PMTA by taking advantage of "Bridging" and Data Sharing.

And when AMESA formed, I thought they would be a Model for Other Trade Orgs.

 

[Lessifer]

Well, remember, this is a Pre Market Tobacco product Application. You have to prove that your product is not likely to cause someone to start or continue using a tobacco product, including yours. It's pretty insane.

The only ones I see being able to pass this test would be the crappy cigalikes made by BT, because they definitely don't make you want to continue using them.

 

[Katya]

Well, remember, this is a Pre Market Tobacco product Application. You have to prove that your product is not likely to cause someone to start or continue using a tobacco product, including yours. It's pretty insane.

The only ones I see being able to pass this test would be the crappy cigalikes made by BT, because they definitely don't make you want to continue using them.

Which is why we need to either (1) convince the OMB/OIRA to send the regs back to the FDA or (2) convince Congress to pass one of the two bills that change the grandfather date.

Otherwise, we're screwed.

 

[Lessifer]

Which is why we need to either (1) convince the OMB/OIRA to send the regs back to the FDA or (2) convince Congress to pass one of the two bills that change the grandfather date.

Other than that, we're screwed.

Well, those are in the general tobacco regulations, not just vape specific. In reality, if you consider vapor products to be tobacco products, the OMB/OIRA would be remiss in its duties if it did not ensure that those regulations applied to all tobacco products, vapor products included.

So either vapor products need to avoid the classification of "tobacco product" or the FSPTCA needs to be amended so that there is a different standard for non-combustible tobacco products, which would include vapor products.

Or at least that's my interpretation.

 

[Katya]

Well, those are in the general tobacco regulations, not just vape specific. In reality, if you consider vapor products to be tobacco products, the OMB/OIRA would be remiss in its duties if it did not ensure that those regulations applied to all tobacco products, vapor products included.

That's not how I see it. The OMB/OIRA could simply reject the proposed deeming regs as too restrictive and harmful to small businesses and send them back to the FDA for a revision. If they did, that would be the end, at least for a long while. This administration is coming to an end, even Zeller may be gone. Who knows who will win the elections? Things may change dramatically. If we can stop this administration from passing the deeming regs as proposed, at the very least we will have bought some much needed time to rethink everything, regroup, redefine, reclassify, whatever.

Time is on our side. The longer the e-cigs are on the market, the harder it will be for anyone to squash them.

 

[zoiDman]

That's not how I see it. The OMB/OIRA could simply reject the proposed deeming regs as too restrictive and harmful to small businesses and send them back to the FDA for a revision. ...

This ^^^ is Right on the Money.

And what EVERY Business Owner that Sells e-Cigarettes/e-Liquids should be Doing.

Now!

 

[navigator2011]

... could simply reject the proposed deeming regs as too restrictive and harmful to small businesses ...

And, this is the crux right here. I doubt that the Democratic party wants to be seen as destroying an entire industry, killing small businesses, causing an increase in unemployment, and sending potentially greater than 9 million vapers toward smoking cigarettes. And, now, the data suggests that destroying vaping will cause adolescent vapers to take up smoking cigarettes, so add that to the list, too.

So, while they really, really want to kill off vaping, I'm positive they will weigh the downside. And, during a campaign year! Can you imagine the fodder the Republicans would have? I'll bet all of the political optics are being considered very carefully. If anything, it is the "optics" that will work in our favor. So, the more beneficial articles that are published, the better off we are. At the end of the day, Obama doesn't want to appear as a villain.

 

[Kent C]

If we were talking a new brand of cigarette those who sold
directly to end users bare the burden of regulation.
What am I getting wrong?

The part where the tobacco companies wouldn't have to submit applications - everyone would.

I know you said 'if this were about cigarettes' (which it is not) is where the analogy breaks down. Tobacco companies make them, gas stations sell them. Now if you only meant 'new cigarettes' - yeah, that would be closer.

 

[Kent C]

Having a celebratory cigar, perhaps?

But not one of those premium cigars that are on the chopping block

My guess is that they'll say - be sure to veto (or amend) HR 2058 and HR 3049. sigh....

 

[zoiDman]

But not one of those premium cigars that are on the chopping block

My guess is that they'll say - be sure to veto (or amend) HR 2058 and HR 3049. sigh....

My Magic 8-Ball says that there Will Be and Exemption for "Premium" Cigars.

Now, what a "Premium" Cigar is... No One Actually Knows.

But in the Immortal words of Harkin... "I don't Exactly know what one is. But I Know it When I See It."

 

[Kent C]

And, this is the crux right here. I doubt that the Democratic party wants to be seen as destroying an entire industry, killing small businesses, causing an increase in unemployment, and sending potentially greater than 9 million vapers toward smoking cigarettes.

One - They won't be 'seen' as doing that because the mainstream media would never portray it in that manner.

Two - they've destroyed other industries, products, jobs, and have harmed many people with regulations either directly by not allowing alternatives or indirectly by forcing them to the black market. I see no reason why this would bother them.

Three - even if they were to admit it, they did it because they 'care about children'. And know what's best for you as well.