Deeming Regulations have been released!!!!

[zoiDman]

I actually do respect her. That document was superb, both in content, and clarity. Her other cases have been also quite noteworthy.

And if I am being objective, she interpreted and followed the law, which is her job.

Its the "law" that we all have a beef with.

I sent Judge Jackson's Ruling to an associate of mine who is a Lawyer who has knowledge of Regulatory Lawsuits.

She said that it was one of the Most "Air Tight" Rulings she had read in a Long Time. And something Clearly written with an Big Dollar/High Profile Appeal in mind.

My Issue with it was that the TCA Clearly States that the FDA should be Promoting and Encouraging Less Harmful tobacco Products. When the FDA chucked e-Cigarettes in with Combustible tobacco, this Violated the Intent of Congress under the TCA.

And since the FDA says that it's Mission is to Protect and to Promote Public Health, it is Hard for me to make the Judicial Deference Argument that the previous FDA's Deeming (with regards to e-Cigarettes and other THR Products) is following the Intent of the TCA for THR Products or is aligned with the FDA's Public Health mission.

 

[zoiDman]

That ^^^ I have to agree with.

Previous FDA knew exactly what they were doing. They even had sit-downs with CASAA and others that are fighting for us yet still came up with that draconian deeming.

We inadvertently gave them the ammunition with which they proceeded to take aim at us.

They have forever broken our trust. I will Not forget.

I think one thing that has become Clear by all who have Followed this is that there really Isn't a "FDA".

There is this Administration's FDA or there that Administration's FDA. But there is No FDA where Science, Fact and Public Health outweighs Agenda, Political Grandstanding and Money in all it's dubious forms. ie: Taxes, Corporate Profits, Campaign Contributions/Dark Money.

I believe there was a Time when this was so. And the FDA, for the Most Part, did Much Good Work. But the FDA has slowly Rotted Away from the Top Down. Just as Many/Most/All government agencies have.

 

[mikepetro]

To my knowledge the TCA does not directly address nicotine, only "tobacco".

Synthetic nic has not been ruled on yet. If I were a betting man I would bet that when it does wind up in court, that synthetic gets classified as a drug, and associated ENDS as a "drug" delivery device.

If they didnt classify it as a drug the whole "component" thing would fall apart. Attys could just be marketed for "synthetic nic only".

I keep wondering why they havent regulated nic itself yet? Nic could easily be made into the bottleneck of the whole distribution system.

 

[Eskie]

I keep wondering why they havent regulated nic itself yet? Nic could easily be made into the bottleneck of the whole distribution system.

That's what I keep wondering and worrying about. Shut that down and no one can go anywhere. Another possibility would limit the concentration of nicotine solution that could be sold to a retail customer, and require a license/registration to purchase higher content solution (maybe 60 mg and up). Those licenses would be issued only to those who hold an approval to manufacture a juice, or for use in non-vaping settings (got me on who else uses the stuff outside of BP for their NRT products).

 

[DC2]

And since the FDA says that it's Mission is to Protect and to Promote Public Health, it is Hard for me to make the Judicial Deference Argument that the previous FDA's Deeming (with regards to e-Cigarettes and other THR Products) is following the Intent of the TCA for THR Products or is aligned with the FDA's Public Health mission.

But, but... but... there's a modified risk category now!!
Easy peasy lemon squeezy.

 

[mikepetro]

 

[mikepetro]

But, but... but... there's a modified risk category now!!
Easy peasy lemon squeezy.

Yeah, I wonder what the burden of proof will be to get one of those through.

 

[zoiDman]

...

I keep wondering why they havent regulated nic itself yet? Nic could easily be made into the bottleneck of the whole distribution system.

You Can't really pull the rug out of the e-Cigarette Market all at once. Because that would cause Revolt and an Expedited Black Market.

Better to do things Slow and Methodical. That way there are No Mass Petitions or Letter Drives or People in the Streets Holding Signs.

 

[DC2]

Yeah, I wonder what the burden of proof will be to get one of those through.

I'm assuming that is a rhetorical question.
If not, I can go find a link to how that process works.
(lemon squeezy!!)

 

[mikepetro]

You Can't really pull the rug out of the e-Cigarette Market all at once. Because that would cause Revolt and an Expedited Black Market.

Better to do things Slow and Methodical. That way there are No Mass Petitions or Letter Drives or People in the Streets Holding Signs.

Just freezers full of nic....... (or so I have heard)

 

[zoiDman]

But, but... but... there's a modified risk category now!!
Easy peasy lemon squeezy.

Oh Yeah... Shouldn't be any Problems going down that road.

Modified Risk Tobacco Products

Probably as Easy to get a MRTP order as it is to get a SE with a February 15, 2007 predicate Date.

 

[leftyandsparky]

So when do y'all think 100mg of nicotine will be off the market by?

 

[zoiDman]

Just freezers full of nic....... (or so I have heard)

Of the Entire amount of US Vapers, I wonder how many have a Freezer Full of Nicotine?

30% ?
10% ?
5% ?
Less than 5% ?

 

[leftyandsparky]

I say 5% or less

 

[zoiDman]

So when do y'all think 100mg of nicotine will be off the market by?

Not sure?

I thought that 100mg/ml+ Nicotine Base would have Restricted to Face-2-Face sales Only by now.

 

[mikepetro]

Of the Entire amount of US Vapers, I wonder how many have a Freezer Full of Nicotine?

30% ?
10% ?
5% ?
Less than 5% ?

The vast majority of US Vapers are clueless, and will be caught like deer in headlights.

I would say easily 30% of the members here.
I would also say less than 5% of total vapers participate in any vape related forums or social media.
Somewhere I saw a figure of 30 million vapers, whats the membership on forums like this?

 

[leftyandsparky]

Not sure?

I thought that 100mg/ml+ Nicotine Base would have Restricted to Face-2-Face sales Only by now.

Me too! I guess we will continue to stock up until the website closes down.

 

[mikepetro]

Not sure?

I thought that 100mg/ml+ Nicotine Base would have Restricted to Face-2-Face sales Only by now.

I have been monitoring the price of 1000mg nic for a year now, and it hasnt increased a bit. So there is no supply/demand effect yet.

 

[mikepetro]

MRTP for SNUS


"The FDA’s review of the available scientific evidence concluded that the General snus products, as used by consumers in Sweden and Norway, may pose substantially lower health risks to individual smokers who switch completely to these products for some health outcomes, such as lung cancer or chronic obstructive pulmonary disease. However, the scientific evidence is insufficient to support that substantial reductions would be observed across the full range of risks posed by tobacco products (e.g., negative effects during pregnancy), as would be implied by a generalized statement about health risks as compared to smoking."

OK, based on the current level of bonafide scientific studies, hold vaping up to the above benchmark.

 

[stols001]

I think it's got to be less than 5% if that. Not sure if suppliers want to be instructing their vapers to stock up on nicotine. I mean, it's risky if anything happens to someone if they recommend DIY juices, they'll get blamed. Also, I'm sure that some suppliers want to be seen as cooperating with the FDA and educating consumers past a "This is CASA," flyer, which most people will ignore. I mean, that's what people do. So, it's unsurprising to find most of the market shifts yet, though a few suppliers are closing their doors. I have found if anything, a slight dip in the price of raw nicotine, though it was around/right after July 4th, and whatnot. I like Nicotine River and they sent me what seemed to be an obscene amount of product for the price...

I think if there is any squalking generally, it's going to either happen right before, or right after. There will be plenty of complaint, as most people tend to react to, (usually too late) rather than Plan for something like this. There will be general FDA talk a bit, followed by thinking it won't be so bad, doing nothing, then BAD bad bad. Sigh.

Anna