Deeming Regulations have been released!!!!

zoiDman

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Evolv only has to do it if they sell a "finished retail" device, they do not have do it for boards that other people use in their devices.

I could see a Scenario where Evol might want to Share some of the Financial Burden of doing a PMTA.

Doesn't Evol Hold some Patent(s) on some of the Technology that goes into their Boards.
 
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mikepetro

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I could see a Scenario where Evol might want to Share some of the Financial Burden of doing a PMTA.

Doesn't Hold some Patent(s) on some of the Technology that goes into their Boards.
They dont need a PMTA to sell the boards, since a PCB with a few chips is not "a finished tobacco product". They can sell all the boards they want to. It is up to whoever assembles them into a Mod and offers them to commerce to do the PMTA.
 

mikepetro

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I just read about synthetic nic, is that a possible alternative if nic ends up taxed or deemed out? I know it is expensive but maybe the price will come down.
Nicotine, even if synthetic, was deemed a tobacco product and subject to the Deeming.
 

f1vefour

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I'm Not Trying to Debate you.

I just Can't Figure Out what these Numbers are you keep Posting.
FDA estimated $300,000 -
$500,000 total cost per SKU for entire PMTA in its
Regulatory Impact Analysis

Additional PMTA Costs
● Literature review
● Clinical Trials
● Other Toxicology Testing
● Behavioral Studies or Surveys on Consumer Perceptions
● Label Comprehension
 

mikepetro

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FDA estimated $300,000 -
$500,000 total cost per SKU for entire PMTA in its
Regulatory Impact Analysis

Additional PMTA Costs
● Literature review
● Clinical Trials
● Other Toxicology Testing
● Behavioral Studies or Surveys on Consumer Perceptions
● Label Comprehension


The FDA has revised those figures, this snippet is from a FDA document:

upload_2020-8-22_8-10-57-png.903057


Link: https://www.fda.gov/media/130833/download
 

zoiDman

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They dont need a PMTA to sell the boards, since a PCB with a few chips is not "a finished tobacco product". They can sell all the boards they want to. It is up to whoever assembles them into a Mod and offers them to commerce to do the PMTA.

I'm not say'n that Evol needs a PMTA to sell a Board. As you Mentioned, it wouldn't be Considered as a "Finished Tobacco Product".

But if the Name of the Game is to Make Money, Evol may see a Better Business Model of them paying for the Bulk of Technical Testing that goes into a PMTA. And then letting a "Mod" maker go the Last Mile with the Cosmetic and Youth Appeal side of things.

And once a "Mod" with a Specific Evol Board got a PMTA, all the Work that was put into the Technical Side for the Board could be used as "Bridged Data" (at virtually No Extra Cost) on another PMTA using the same Board.

And Evol would "Own" the Bridge Data.
 
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f1vefour

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zoiDman

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FDA estimated $300,000 -
$500,000 total cost per SKU for entire PMTA in its
Regulatory Impact Analysis

Additional PMTA Costs
● Literature review
● Clinical Trials
● Other Toxicology Testing
● Behavioral Studies or Surveys on Consumer Perceptions
● Label Comprehension

Gotcha. Thank you.

JMO. I question whether or Not ECBlend spent more that $500,000 or $600,00 for the Entire 101 Submissions.

And that Vast Majority of what the Spent went to 3 or at Best 4 Individual Flavors. 2 Tobacco Flavors, 1 Mint/Menthol Flavor, and perhaps 1 Fruit Flavor.
 
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zoiDman

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Thank you, that is certainly more reasonable.

@zoiDman If you knew these figures which I'm relatively sure you did why didn't you simply state them instead of questioning me?

Because I didn't know if you Meant the $550,000 was per PMTA? Or the Total Amount Spent on All the PMTA's? Or if that was a Sales Figure? Or maybe something else?
 

stols001

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Squabblers and nigglers should knock it off and there is no reason not to ask a legitimate question about a figurer. This is kind of exactly what this thread does not need.

I personally don't think asking where a figure came from is "passive aggressive" things change and people like, have different info all the time.

We need to get MORE people to this thread from other threads frankly although at this point... I almost don't want to scare someone off with too much information at THIS POINT although there is STILL time so maybe it's worth it.

I am so grateful I read this WHOLE thread digressions and all when I was new. I learned a TON and started planning. Quitting was so hard there was NO WAY I would be without vape. NOPE.

I hope some nic companies manage a PTMA but I am doubtful (I know Heartlands was going for it?)

Also, there will be far less variety and less flavors. Costs are going to rise. This is the bottom line.

I know I can survive deeming but I don't know about everything else. Sometimes I think vapers and vaape shops are the least educated popel eon the planet. Sigh.

This is our LAST CHANCE TO SAY STOCK UP. and that does not mean buy a gallon bottle of premade eliquid. It just doesn't. Nic, DIY it's... you have to.

In any case, I will point folks to this thread, but I will say like, vapers are a bit like cancer patients starting chemo without their knowledge or consent. It will be ugly HELL I KNOW I WOULD relapse personally.

READ THE FINE PRINT!!

@mikepetro I kind of agree with you but I think there may be MORE lying by the tobacco folks on their position than by the WHO and CDC about COVID. But, it is going to be CLOSE mark my words.

Anna
 

f1vefour

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Anyone know where I can find a timeline of when the various Ruyan e-cigarette were released to the market? I'm specifically interested in knowing when then Ruyan V8 was released and in which countries, but a full timeline of the Ruyan models would be great. I can't find much on google.
There is a review on RY8 from early as 2012
 

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