Deeming Regulations have been released!!!!

[Bob Chill]

I took a break from posting to try and get anger out of my head and think more rationally. It's not working. I've scrolled through a bunch the comments and responses on the FDA facebook page and a lot of other discussions over the last day or so.

The responses I see from most elected officials who are anti-vaping and the FDA can all be summed up with a simple expression. They don't even need to write 1 page letters or canned responses. They are all just doing this:

"These regulations will completely destroy the industry and hand it over to big tobacco."

Response: ¯\_(ツ)_/¯

"It makes absolutely no sense to require a bottle of e-liquid containing zero nicotine to be labeled contains tobacco."

Response: ¯\_(ツ)_/¯

"The regulations will actually increase harm to citizens and not decrease it."

Response: ¯\_(ツ)_/¯

"The PMTA requirements are not a viable pathway for over 90% of all e-liquid and hardware manufacturers. This will result in 10's of thousands of jobs that will be lost."

Response: ¯\_(ツ)_/¯


That's all we get from our elected officials and regulatory bodies. A big bag of ¯\_(ツ)_/¯

Thankfully we have a select few on our side who may save us from disaster. But we'll never get the market back as we know it.

 

[rosesense]

Bill G with the ">99% of all products won't exist" and huge majority of posters that either agreed with him or re-quoted him?? Frankly anyone who took the time to read the original draft in 2014 (with the 'known exceptions' - Tom Baker, et al), had a pretty good grasp of what was going to happen.

For myself, I was optimistic that we had enough power to get this to something more realistic. I knew we would be regulated and taxed but never thought they could go so far as they have.I couldn't wrap my head around this actually passing due to what was going on in my state and certain legalization which no one ever thought would happen here, yet it did.

 

[Kent C]

Exactly! I'm only aware of exactly one PMTA that has ever been approved which reinforces the "... no guarantee..." point you make. That's 100K pages from Swedish Match. Mike covered this issue in 2015.

I admire the candor of the ProVape Blog post. Direct quotes from one of the owners. It should help some folks understand the gravity of these issues. And yes, my 2.5 is still running perfectly after almost 3 years. Please stock up!

/sigh
/sad

Stay Strong! Fight!

Thank you and 1000+ likes And Bill G has told us time again how many applications have been turned down or just 'pocket vetoed' - no action, no response, no communication from the FDA. The odds, if they stay that way, are not good for any business big or small.

 

[mgmrick]

How we vote may have a big impact on vaping...facts are facts. I know how I am voting

 

[Kent C]

I think what the Member who mentioned toning down the Partisan Blame Rhetoric was saying is at This Point, we should be Concentrating More on Trying to Do Something about the Hole we are in. Verses making who Dug the Hole the Main Emphasis of this Thread.

Your House is On Fire Right Now. Maybe it would be a Good Time to think about Ways to Put it Out? Or at Least, Minimize the Damage that the Fire is Causing?

Bull. It's about who is still digging the hole and who is starting more fires - and that should be pointed out. If we don't address that, then it just continues as is. IF you were against the wars in Iraq and Afghanistan and didn't point out who it was who was pushing for them, it isn't partisan bickering. Whether or not you were for or against the wars - it was just fact.

 

[mcol]

Fact is they manage to turn every single issue of importance to people into
a political issue, and have been doing this for awhile. I guess it's so the lines
can be drawn and we all pick a side, thereby decreasing our army.
I know how I'm voting too.

Edit: Oops by 'they' I mean politicians.

 

[Kent C]

For myself, I was optimistic that we had enough power to get this to something more realistic. I knew we would be regulated and taxed but never thought they could go so far as they have.I couldn't wrap my head around this actually passing due to what was going on in my state and certain legalization which no one ever thought would happen here, yet it did.

That last battle took about 40 years, although the 'industry' wasn't shut down :- ) It's a good example of how 'white' a 'black market' could be - not that at the 'dealer level' there weren't turf problems, etc. but at the consumer level - not so much.

 

[zoiDman]

Bull. It's about who is still digging the hole and who is starting more fires - and that should be pointed out. If we don't address that, then it just continues as is. IF you were against the wars in Iraq and Afghanistan and didn't point out who it was who was pushing for them, it isn't partisan bickering. Whether or not you were for or against the wars - it was just fact.

Oh Sure Kent. Lets now Debate whether we should be Debating.

All the While the Sand is Slowly running out of the Hourglass.

 

[nineironman]

For myself, I was optimistic that we had enough power to get this to something more realistic. I knew we would be regulated and taxed but never thought they could go so far as they have.I couldn't wrap my head around this actually passing due to what was going on in my state and certain legalization which no one ever thought would happen here, yet it did.

Rosesense, I too am here and the D's whom have run our state for decades have turned it into the biggest " nanny state of all" I may have to rethink my position with regards to my my political affiliations.

 

[Kent C]

Oh Sure Kent. Lets now Debate whether we should be Debating.

All the While the Sand is Slowly running out of the Hourglass.

Why is it the losing side always complains about 'partisan bickering' It's not about 'debating about debating' - it's about pointing out the facts and dealing with them - as I'd point out - which is what, if we can rely on what we both have said, we, are doing and have done - CTAs and over and above that. I'm sending 4 figures to seviausa/khlaw, this week. That's not debating about debate.

 

[YoursTruli]

Why is it the losing side always complains about 'partisan bickering' It's not about 'debating about debating' - it's about pointing out the facts and dealing with them - as I'd point out - which is what, if we can rely on what we both have said, we, are doing and have done - CTAs and over and above that. I'm sending 4 figures to seviausa/khlaw, this week. That's not debating about debate.

I tend to think we vapers are ALL on the losing side of this and beating each other up with haha comments like this makes it better somehow? Yeah... it is not hard to imagine why we never in all the years of being aware of the federal and states legislation could pull together to save something we all really believe in and do not want to lose.

 

[SeniorBoy]

So...Girls and Boys

I kept wondering what the FDA application fee is for a PMTA. After slogging through part of a webinar by the desk killers it turns out that IF you want to play ball with the FDA you pay a "User Fee" on a quarterly basis. Naturally it's laden with tons of bureaucracy, calculations that give me a migraine, and paper work to calculate your invoice. I think I found some documents which should give all of us a pretty good idea (though not exact) of exactly how much money the FDA collects for the privilege of submitting a PMTA etc. Fasten your hard drives and grip your mouse:

First you submit so they can calculate:

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM405202.pdf

The actual money you pay via their own ball park calculations:

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM462190.pdf

Even the cheapest privilege cost 400K+ per year just to play ball with the FDA. YIKES!

EDIT: It's worth noting that this is NOT a one time "User Fee". As long as you play in the FDAs sandbox you pay this fee which gets tweaked/changed every year.

 

[Bronze]

So...Girls and Boys

I kept wondering what the FDA application fee is for a PMTA. After slogging through part of a webinar by the desk killers it turns out that IF you want to play ball with the FDA you pay a "User Fee" on a quarterly basis. Naturally it's laden with tons of bureaucracy, calculations that give me a migraine, and paper work to calculate your invoice. I think I found some documents which should give all of us a pretty good idea (though not exact) of exactly how much money the FDA collects for the privilege of submitting a PMTA etc. Fasten your hard drives and grip your mouse:

First you submit so they can calculate:

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM405202.pdf

The actual money you pay via their own ball park calculations:

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM462190.pdf

Even the cheapest privilege cost 400K+ per year just to play ball with the FDA. YIKES!

This is their way around the"constitutionality" of their regs. They can say they are not prohibiting anything. They just make it so damn expensive that in effect they do.

 

[zoiDman]

Why is it the losing side always complains about 'partisan bickering' It's not about 'debating about debating' - it's about pointing out the facts and dealing with them - as I'd point out - which is what, if we can rely on what we both have said, we, are doing and have done - CTAs and over and above that. I'm sending 4 figures to seviausa/khlaw, this week. That's not debating about debate.

Hello?

There are No Winning or Losing "Sides" here. Only Vapers. And we are ALL Losing BIG TIME.

Being a Lifetime Republican Voter like myself Doesn't somehow make it Any Better for Me. Or make it Any Worse for a Lifelong Democratic Voter. We are all in the SAME Boat.

And I would Rather Work on trying to Find a Solution(s). Than to keep "Point Out" what has Been Pointed Out Ad infinitum for the Last 2 Years.

We Get it.

 

[mgmrick]

This is a political issue..facts are facts someone posted a few posts back how the r's..and the d's..voted.

 

[rosesense]

Slightly ot but I have been liking a lot of posts in this thread and I just got a pop up from ecf asking me if I am sure I want to like the post. What is that about? Never had that happen before, weird.

 

[YoursTruli]

That is weird @rosesense I have never had that happen

 

[Lessifer]

This will be a somewhat off topic post, so skip it if you like. Also, I will likely be afk for a few hours so I won't really be debating it.

I am socially liberal. Most of the major issues that I care about, and know that republicans are usually against, are fairly well settled or protected for the time being(although a change in the SC could upset that).

For that reason, at this time, I will likely be a single issue voter for the upcoming elections and vaping is that issue. Maybe not for POTUS, but we'll see, depends on how the candidates respond.

I'm not urging anyone else to act the same, but I am making this known to every representative that I will have the opportunity to vote for.

 

[Kent C]

Hello?

That's arrogant and disrespectful.

There are No Winning or Losing "Sides" here. Only Vapers. And we are ALL Losing BIG TIME.

Here's where the "Hello?" belongs.

What is being pointed out, is new to some here by their posts. Perhaps you should just skip over what I have to say for a while. I'll do the same. Deal?

 

[zoiDman]

... Perhaps you should just skip over what I have to say for a while. I'll do the same. Deal?

Sounds like Good Idea Kent.

Deal.