FDA TVECA post table of contents for Deeming Final Rule

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zoiDman

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A 1 liter bottle of 100mg concentrate costs $50 and will last me 3+ years. Three bottles would take up the same space as two family size frozen entrees, cost $150 and last me 10 years. Then it's how many TC mods and fasttech rda's would it take to go that distance? Stockpiling is NOT expensive. I'm more concerned about taxes than outright bans (I ain't payin no more damn smoking taxes). But taxing ecigs is problematic. A 1 liter, $50 bottle of nic takes the place of $9,000 worth of cigarettes. Am I going to need a refrigerated gun safe? Funny to think about.

I just Hope that 1 Year from Today that there will be a Similar Post about someone being Able to still buy 1L of Nicotine Base.
 

kbeam418

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Honestly, I think they are banking on us returning to smoking. Instead of taxing the heck out of vaping, they will demolish it, and assume they will get their already established money back from cigarettes. They are wrong about that for many of us.

Sad thing is that's exactley what will happen, I'll stockpile on nicotine that'll last me about 10 years. But how many people are going to that, hell will that even be legal?
 
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rhelton

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That's why, in addition to the dozen regulated mods I have stashed, I also got about 10 mechanical mods - with a dozen kicks for them. they're good up to 15W, which is perfect for me
Lets not forget you can get Raptor and OKR parts from any electronics parts house. They were designed for LED lighting.
 

Rossum

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I believe the Provision starting on line 240 is so a Manufacture/Broker/Distributor would Not be Subject to End User Regulations.
Well if we we enthusiasts can still buy nic base, and flavors intended for vaping, which are clearly not "finished ENDS products", then there's no reason for us to stock up, is there?

BTW - How Big of a Freezer do you have? Having Read your Posts over the Years, I Couldn't Imagine you would Skimp Out on a Freezer.:)
Based on the rating plate on the side, the stand-alone chest freezer appears to be 25.3 cubic feet. The problem is, it's not mine. You see my wife keeps it pretty dang full of silly, non-essential stuff like food, and she begrudges any space that my nic base takes up in there, as well as in the freezer section of the refrigerator. So the real solution is to get my own, preferably with with a nice hasp and padlock on it (purely for safety's sake, not to keep my wife from filling it with more food, of course). I would have done that a long time ago if I could figure out where to put it. Yes, yes, it's a first-world problem. :D
 

Cam775

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LOL, what? The president quit smoking like 6 years ago. The only thing you've seen is him chewing on nicotine gum...
He was just photo'd this year with a pack in hand. I will concede that he's hiding it from the media better than he was prior to 2011.

....BTW - Why are we so Sure that there will be a 2 Year "Grace Period" on e-Liquids?
I'm not sure if someone answered this question but the short version is that the regs state that manufactures have 6 months to submit ingredients & *I believe* their process and then must apply to the FDA for approval (which is what costs the $2-10mil PER PRODUCT) within 2 years. So basically they have 2 years to comply and convince the FDA to give them approval or shut down or go black market, lol.

First of all comparing what happens in WESTERN European democracies to the way things function in countries like Dubai....?...doesnt seem to make a very valid paralell IMO

The reason I brought it up is because the proposals brought up in the US and those about to come into effect in the EU are very similar and clearly going in the same direction !

;) BT, BP and their interests are GLOBAL and the motivation behind all this ($$$$$ for the gov and for their "allies" ie. these big companies) is too!


Here we "missed" the opportunity to do something about this regulation (the EURO TPD) while it was still possible....

....mainly due to complacency+ the lack of information of the "general" vaping public who didnt know what was being prepared (and/or didnt believe it could really happen in a "free",democratic country) and for all these various reasons FAILED TO ACT !

Result ? Ours have already been voted and, in some countries, sometimes even applied!

To sum it up,the motivation behind my post was to say :

WATCH OUT.... THIS CAN HAPPEN TO YOU TOO if you DONT ACT NOW !

and for that reason I feel it absolutely does have it's place in a US call to action thread!
Thank you for posting here and continuing to. I appreciate that you are helping to open our American eyes to the negative consequences we could easily be facing if we don't take this seriously and act now. Some people are so focused on following "those in the know" they miss the big picture.

Jeebus. Having just read the "Guidance" for PMTAs for ENDS that OmniVape posted yesterday, I can only conclude that:
  • The above-board retail vape industry as we know it will be wiped out when they start enforcing that. Sure, there will be a few BT and BV products available from companies that have the resources to file the required applications, but the rest of what we've come to know and enjoy, particularly the wide variety of products... Gone, because they are incapable of jumping through hoops held that high.

  • The statement (starting at line 240) that: "an e-liquid that is sold or distributed for further manufacturing into a finished ENDS product is not itself a finished tobacco product and, at this time, FDA does not intend to enforce against such such e-liquids.." is rather puzzling. That does seem to leave the door wide open for DIY, as well as entrepreneurs willing to engage in, let's just say, "counter-economics". I could speculate why they are doing this, but I'll refrain for the time being.

  • I need a bigger freezer.
THIS!!!!!!!! THIS!!!!! IS BEAUTIFUL!!! If I'm reading this correctly ejuice manufacturers could sell a mixture of their concentrates, similar to Mom & Pops. It wouldn't be an end product because you'll still need to mix pg/vg to be able to vape it.

This is very confusing though because earlier in this thread it appeared that some of the language used left the regs open ended for the FDA to use their discretion to regulate ANY PART of anything that goes into the end product if they choose to. Am I confused or missing something or is it just typical obfuscating, contradictory, bureaucratic :censored: jargon?
 
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Jaguar G

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I applaud the effort to call and write elected officials, but I detiest the fact this is becoming our team vs. their team.

I am a grown man, former service member, tax payer, hard working, honest and educated free American citizen. I have no use for regulators who would deny my quiet enjoyment of my method of nicotine delivery.

It is no one's concern but mine and my friends and family how I enjoy my nicotine. As a soverign man I refuse to play this game of theirs. My freezer is full and I can make or purchase on a black market anything else I need. I will openly defy all their rules, I will resist this tyranny.
 
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zoiDman

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Well if we we enthusiasts can still buy nic base, and flavors intended for vaping, which are clearly not "finished ENDS products", then there's no reason for us to stock up, is there?


Based on the rating plate on the side, the stand-alone chest freezer appears to be 25.3 cubic feet. The problem is, it's not mine. You see my wife keeps it pretty dang full of silly, non-essential stuff like food, and she begrudges any space that my nic base takes up in there, as well as in the freezer section of the refrigerator. So the real solution is to get my own, preferably with with a nice hasp and padlock on it (purely for safety's sake, not to keep my wife from filling it with more food, of course). I would have done that a long time ago if I could figure out where to put it. Yes, yes, it's a first-world problem. :D

Like I said, I believe the Distinction will be to End Users.

Right now someone like Wizard Labs will sell to an Individual. But after Post Deeming, what would happen if you Could Only buy from them if you had a Business Account to be Regulation Free? And you know what can be Entailed to have a Business Account. Business ID Number(s), Business Bank Accounts, etc.

---

You could Buy your Own Freezer. And then put a Hasp and Lock on it. Or you could just put a Hasp and Lock on the One you have. And then Not give your Wife the Key.

Probably the 1st Option would be Better though.

;)
 

zoiDman

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...

I'm not sure if someone answered this question but the short version is that the regs state that manufactures have 6 months to submit ingredients & *I believe* their process and then must apply to the FDA for approval (which is what costs the $2-10mil PER PRODUCT) within 2 years. So basically they have 2 years to comply and convince the FDA to give them approval or shut down or go black market, lol.

...

If you come across where you Saw this, Please do post it.

Because I've been Reading the PMTA Guidance that TVECA released, and I'm not getting that Same impression.
 

collinsmcrae

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Perhaps if you have followed what the FDA has published about "Intended Use" you would have a Different Opinion.

Here is a Good Thread you might consider Reading...

https://www.e-cigarette-forum.com/forum/threads/big-news-coming-out-of-fda.703013/
The language in these proposals must be comprehensive, for sure. You can't submit some half assed document to the White House. However, this doesn't really show that they understand this technology, or the advanced vaping industry really. And they can enact all of the open ended, and overreaching policies that they want, but that is not going to stop us from coming at them from all angles. Have the online piracy acts slowed down Internet piracy? Why not? Because the people behind it all are smarter than them. Also, online piracy And personal vaporizers are similar in that much about them is abstract. Abstract concepts are difficult to control, or to even get a handle on. It's easy to say a cigarette is a cigarette, and it's really hard to make a case that a pack of smokes is intended for any other use. But a variable wattage power supply? Anyway, I don't want to continue arguing with a fellow vaper who just doesn't want to see this industry get crushed. We both agree on the important matter, which is that this whole situation is a ....ed ... abuse of power. I've sent out my email and made my call, as most of us here have, and I guess we'll just have to see. If these things do go through unhindered, I hope that I am right in my belief that they won't actually be able to stop the advanced vaping market, but I also know that I could be wrong. Time will tell.
 

zoiDman

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The language in these proposals must be comprehensive, for sure. You can't submit some half assed document to the White House. However, this doesn't really show that they understand this technology, or the advanced vaping industry really. And they can enact all of the open ended, and overreaching policies that they want, but that is not going to stop us from coming at them from all angles. Have the online piracy acts slowed down Internet piracy? Why not? Because the people behind it all are smarter than them. Also, online piracy And personal vaporizers are similar in that much about them is abstract. Abstract concepts are difficult to control, or to even get a handle on. It's easy to say a cigarette is a cigarette, and it's really hard to make a case that a pack of smokes is intended for any other use. But a variable wattage power supply? Anyway, I don't want to continue arguing with a fellow vaper who just doesn't want to see this industry get crushed. We both agree on the important matter, which is that this whole situation is a ....ed ... abuse of power. I've sent out my email and made my call, as most of us here have, and I guess we'll just have to see. If these things do go through unhindered, I hope that I am right in my belief that they won't actually be able to stop the advanced vaping market, but I also know that I could be wrong. Time will tell.

Very well put collinsmcrae.

:thumb:
 
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Cam775

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If you come across where you Saw this, Please do post it.

Because I've been Reading the PMTA Guidance that TVECA released, and I'm not getting that Same impression.

This is it...am I confused?
Screen shot - haven't checked if it differs from the deeming doc we know. But the part where it says 'The term is not limited to...." I don't recall that wording from before. And the "whether they are sold to consumers for use in ENDS...." IOW, like 'closing the loophole' for eliquid unlike on RYO where cig tobacco was labeled 'pipe tobacco'.

161708521.XILcIk5M.ScreenShot023.jpg
 

zoiDman

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This is it...am I confused?

Are you Confused? I dunno... Probably a Little.

Because I think we are ALL Confused by what is going on by all this to Some Degree. I know I am.

What I would Really like to see is some Analysis of what TVECA says is what the OIRA is Reviewing by someone like SFATA or by CASAA.
 

Cam775

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Totally agreed!!!

I'm reading just the Background, section II and combined with what was quoted in my reply above it seems pretty open ended to me. The FDA can pick and choose any product they feel relates to vaping, tobacco (which should read nic, and my *hope* is that alone will send them back to the drawing board as others have also stated) in it or not, i.e. batteries/flavor concentrate and make the manufacturer get approval.

Someone previously did make a point that nic base has been around prior to 2007. I know flavoring has been around prior to 2007 but base? And if it has and they can't force it for approval, is there anything saying that only manufacturers or those with a wholesale license would be able to buy it? I'm not seeing anything to that effect at all. ETA: The first e-cig developed in 2000 used nicotine diluted with pg. So it has been around before 2007.

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zoiDman

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Totally agreed!!!

I'm reading just the Background, section II and combined with what was quoted in my reply above it seems pretty open ended to me. The FDA can pick and choose any product they feel relates to vaping, tobacco (which should read nic, and my *hope* is that alone will send them back to the drawing board as others have also stated) in it or not, i.e. batteries/flavor concentrate and make the manufacturer get approval.

Someone previously did make a point that nic base has been around prior to 2007. I know flavoring has been around prior to 2007 but base? And if it has and they can't force it for approval, is there anything saying that only manufacturers or those with a wholesale license would be able to buy it? I'm not seeing anything to that effect at all.

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Here is the Problem that I see.

Yes. Nicotine Base has been around prior to 2007. So Nicotine Base or Unflavored could go down the Significant Equivalent (SE) Path. Which would be Vastly Easier to Less Expensive to be Approved.

But for a Flavored e-Liquid to go down the SE Path, it would have to the same Ingredients in the same Proportions as an e-liquid that was sold Prior to 2007. And that might be Very Hard to find an e-liquid that Matches this Criteria.

So probably almost All e-liquids will have to go down the PMTA Route.

But here is the Big One. That 2 Year Period that everyone seems to keep Mentioning, when I read that for the 1st Time in an FDA Guidance, it was Talking about Hardware. And it Didn't make many References to e-Liquids. So I'm just Not Sure if it can be said what will Apply to Hardware will Apply the Same Way to e-Liquids.

And from the People I talk with, they seem to feel the Same Way. That the FDA is Focused on the Part that Goes into your Lungs. Not so much the Part that Screws onto a Mod.

It could be that the FDA will allow something like Diketones in Flavorings to continue for 2 Years while someone prepares some Paperwork to be Submitted. But I just don't see it.

And that is why I would like to see some of the Groups, that have the Lawyers, like SFATA or CASAA or TVECA come forth Explain what they think is going to Happen.
 

Alexander Mundy

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The 2 year thing: IIRC in the draft deeming doesn't an SE or a PMTA have to be filed within a short period of time (Maybe 60 or 90 days) to continue selling for that 2 year or FDA approval or denial whichever happens first. In that case no mom and pop or anyone that doesn't reasonably think they have a shot at passing is going to sink the money and time into an application. Anything short of a full blown application would be denied very quickly by prescreeners then on to the next. Come to think of it, if that 90 day or whatever maybe 120 is the case, you had better already have a year or 2 of prep for the application already.

Edit: maybe you just had to file with the FDA that you were going to submit within the 2 year time frame.

Either way say goodby to the small vendor section here on ECF.
 

StormFinch

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There was a lot of work done in many states, and here, fashioning local and regional bans. When fashioning his ban the gov of AR specifically referred to ejuice as a tobacco product and brought them under that title so that they could be taxed........

and that tax vote was specifically put off sometime into the future at least 2 years from now.

Why do you think that is? :) Because at the time there was no FDA rule yet, but the ducks are being put in a row to have that tax $$ coming in.

Actually, the reason Hutchinson knew they couldn't tax it now was because the legislative year was about to end. They barely got the bill they passed in under the wire, and the one that was submitted for taxing juice was a mess written by someone who didn't know bill writing from a set of chinese desk building instructions. The next legislative calendar starts in (now somewhat less than) two years.

Edit: sorry, the new format is still... uhm, new to me. ;)
 

Rossum

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Given everything the FDA wants in PMTA, it seems to me that it would take a year or more to prepare one, and the FDA's own estimate is that 5000 man hours are needed. So a two year "grace" period is probably the lowest they think is likely to withstand a court challenge.
 

inspects

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Totally agreed!!!

I'm reading just the Background, section II and combined with what was quoted in my reply above it seems pretty open ended to me. The FDA can pick and choose any product they feel relates to vaping, tobacco (which should read nic, and my *hope* is that alone will send them back to the drawing board as others have also stated) in it or not, i.e. batteries/flavor concentrate and make the manufacturer get approval.

Someone previously did make a point that nic base has been around prior to 2007. I know flavoring has been around prior to 2007 but base? And if it has and they can't force it for approval, is there anything saying that only manufacturers or those with a wholesale license would be able to buy it? I'm not seeing anything to that effect at all. ETA: The first e-cig developed in 2000 used nicotine diluted with pg. So it has been around before 2007.

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Many of the general public are much smarter than those supposedly serving us. I would bet within the next year the vaping industry will make unheard of leaps and gains like they have in the previous twelve months.

I've only been tobacco free for eleven months, I'm stunned at the innovation which has transformed in this VERY short period of time. I expect the technology to continue evolve at a radical rate.
 
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