Deeming Regulations have been released!!!!

[YoursTruli]

Lawsuits in 5-4-3-2 ...........

The future is in popcorn.

I hope you are right because they changed the rules after all those PMTAs were submitted costing businesses, who stood no chance of approval, millions of dollars, hard to believe that would be legal. A big part of me is doubtful though as most of those companies are minor players. Maybe a class action.

 

[thanswr1]

The entire premise of the PMTA's was wrong. From proving they were not harmful to "moving the goal posts" proving e-cigs didn't cause a rise in teen smoking.

First off, where is the harm? There hasn't been one death or injury with juices bought from legitimate vendors and properly used equipment. What the hell is the point of FDA regulation? What the hell is the point of proving "no harm" when there hasn't been any harm?

Second, requiring an age limit of 21 to buy cigarettes seems to be enough for the FDA when it comes to the "cancer sticks". In other words, real harm producers get a pass, while those who cause no harm have to jump through hoops.

The PMTA process was a sham from the beginning. That someone thought it was a good idea to change standards AFTER millions were spent on PMTA's proves idiots are running the FDA.

I don't see how there won't be lawsuits. Especially if the FDA goes after heavy hitters like Aspire, Triton, etc.

This sorry excuse for FDA policy is far from over. I am almost certain of that.

 

[ShowMeTwice]

Progressive one hasn't replied. Wonder why. Initially I thought it was AOC using an alias.

 

[MacTechVpr]

I'm confused. What difference does it make? When the NEW DEAL is always the same as the OLD DEAL. They take, we lose. Same deal, different wrapper. I say, tang yu berry mush fandango. No deal.

Good luck.

The human race divides politically into those who want people to be controlled and those who have no such desire.
–Robert A Heinlein

 

[WorksForMe]

Progressive one hasn't replied. Wonder why. Initially I thought it was AOC using an alias.

She was just trolling. She joined the forum, made one post, and then logged off and didn't come back.

.

 

[JCinFLA]

@zoiDman - Are all of those MDOs for eliquids only...or for other products, too? Or does anyone even know the answer to that besides the FDA and those companies? I've never bought eliquids from any of them, but I've definitely made multiple purchases from all of these below.

Avail Vapor LLC,9/15
Central Vapors,9/10
DFW Vapor Holdings Inc.,9/8
Ecig Charleston LLC,9/15
Heartlandvapes LLC,9/17
Midwest Vape Supply,9/1
Mister-E-Liquid LLC,9/16
Mountain Oak Vapors, LLC,9/8
Nude Nicotine,9/7
Texas Select Ventures LLC dba Texas Select Vapor,9/14
Vape Hut Inc.,9/13

 

[zoiDman]

@zoiDman - Are all of those MDOs for eliquids only...or for other products, too? Or does anyone even know the answer to that besides the FDA and those companies? I've never bought eliquids from any of them, but I've definitely made multiple purchases from all of these below.

Avail Vapor LLC,9/15
Central Vapors,9/10
DFW Vapor Holdings Inc.,9/8
Ecig Charleston LLC,9/15
Heartlandvapes LLC,9/17
Midwest Vape Supply,9/1
Mister-E-Liquid LLC,9/16
Mountain Oak Vapors, LLC,9/8
Nude Nicotine,9/7
Texas Select Ventures LLC dba Texas Select Vapor,9/14
Vape Hut Inc.,9/13

As far as I understand it, that is a List of OEMs/Retailers who have received a MDO (Market Denial Order) from the FDA as of September 17th. That order could be for 1, or Multiple, or for All Products the OEM/Retailer is currently selling.

And that at this time, the FDA's Primary Focus is on Flavored e-liquids.

 

[zoiDman]

As far as I understand it, that is a List of OEMs/Retailers who have received a MDO (Market Denial Order) from the FDA as of September 17th. That order could be for 1, or Multiple, or for All Products the OEM/Retailer is currently selling.

And that at this time, the FDA's Primary Focus is on Flavored e-liquids.

BTW - Taking someone like Heartland Vapes...

They used to Sell a 1/2 Dozen or so Other Brand Names of Flavored e-liquids that contain Nicotine. As well as their House Brand.

So I could see a Scenario where the FDA issues a MDO to HLV for those Other Brands. While continuing to Evaluate Heartland Vapes PMTAs for their House brands.

This is all Conjecture on my part. But to give Legal Cover to the FDA, they really have to get their Paperwork in order before they MDO a Larger Company with a "viable" PMTA.

Whereas they can probably just Rubber Stamp smaller companies with MDO's who have filled (perhaps) Flakey or Not-Very-Serious PMTA's.

 

[zoiDman]

BTW - Taking someone like Heartland Vapes...

They used to Sell a 1/2 Dozen or so Other Brand Names of Flavored e-liquids that contain Nicotine. As well as their House Brand.

So I could see a Scenario where the FDA issues a MDO to HLV for those Other Brands. While continuing to Evaluate Heartland Vapes PMTAs for their House brands.

This is all Conjecture on my part. But to give Legal Cover to the FDA, they really have to get their Paperwork in order before they MDO a Larger Company with a "viable" PMTA.

Whereas they can probably just Rubber Stamp smaller companies with MDO's who have filled (perhaps) Flakey or Not-Very-Serious PMTA's.

BTW2 - Here is a Situation that gave a Regulatory Lawyer I know a Mild Aneurysm.

Say Nude Nicotine submits a Half Azz, Boilerplate, PMTA for 18mg/ml 100% VG Unflavored Nicotine Base. The FDA reviews it and finds it lacking. So it is Denied. Right?

But at the Same, Heartland Vapes has submitted a 100,000 Page PMTA with in-depth Analysis, Full Blown Supporting Docs, etc., for the EXACT SAME PRODUCT in the EXACT SAME PACKAGING.

The Data Clearly show that HLV went Over and Beyond what was required. And that their submission meets All the Requirements for a Tobacco Product to be sold. So HLV should get approval. Right.

But here is where the Problem lies. Both NN and HLV are wanting to sell the Exact Same Product.

So can the FDA say that one is No Bueno, but the other is Fine?

 

[Katya]

I hope you are right because they changed the rules after all those PMTAs were submitted costing businesses, who stood no chance of approval, millions of dollars, hard to believe that would be legal. A big part of me is doubtful though as most of those companies are minor players. Maybe a class action.

Somehow, not matter what happens in our country, the lawyers always come up on top.

 

[Katya]

I watched a documentary last night on Juul that was interesting and the timeline went all the way from the two guys starting the company to September 9.

The inventors of the infamous Ploom--before Juul.

The Ploom is Here.

 

[hittman]

The inventors of the infamous Ploom--before Juul.

The Ploom is Here.

I remember Tropical Bob posting about the Ploom.

 

[Katya]

I remember Tropical Bob posting about the Ploom.

Right. I do too.

 

[DPLongo22]

Dead horses were made to be beaten.

View attachment 954713

 

[BillW50]

FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix)

 

[mikepetro]

FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix)

"The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline."

Gee, such convoluted logic! Almost like harm reduction logic in the FDAs eye.

 

[zoiDman]

"The Known benefits of stopping smoking [far] outweigh the potential risk from using an e-Cigarette."

...

IFTFY

 

[thanswr1]

Dear FDA

Keep going. You're doing fine. From acceptable levels of cancer risk in Chantix to "moving the PMTA goal posts" after millions had been spend and umpteenth had already been submitted, you're doing a helluva job.

Aww hell, looks like the FDA is writing the court case against them.

 

[englishmick]

I guess this isn't directly about Deeming regs but it touches on perception and where kids get their information, including on the subject of vaping.

I read an article this morning where they looked into what kids themselves thought about the fights going on among adults about school policies. Basically they had close to zero interest in the adult posturing over masks, teaching of race history, bathrooms, and all the rest of the political food fights. What they cared about was getting together with their friends and learning.

"This frustration with their elders — not necessarily those around them, but with the arguments they've watched unfold on the news and in TikTok comment sections — surfaced repeatedly."

"From Texas, Nadia concurred. "I feel like they should maybe stop arguing with each other and see what the younger generation has to say about it, since they're the ones who are being impacted the most."

Anyway the reason I'm posting it here was this comment.

Leah drew a parallel to health education. "My PE teacher showed us the video on why they originally created JUUL pods. The entire curriculum was, 'Don't JUUL. JUUL will kill you.' And he showed us this video that said they originally created it to help people ease off smoking addictions. And I was like, 'That's actually really cool.' It's horrible that they appeal to teens now, but it's really interesting that it started with this good purpose."

Quite likely that PE teacher got fired or blasted by parents.

A kid watched a video providing facts without propaganda and got it right away. Most of what they hear is political posturing and propaganda from all directions, but they are ready and eager to hear facts and draw their own conclusions. And they are smart enough not to trust anything we tell them, which is kind of reassuring.

As the culture war engulfs their schools, kids say adults aren't listening to them at all (msn.com)

 

[rosesense]

nm, already posted info.