Deeming Regulations have been released!!!!

[CublalaLand]

Sometimes when the wind is just right, I can stand outside my home and smell the roadkill from here all the way to the next town. You can't express the inexpressible. Why demand it? So you can mock the futility of grandiosity? Why not listen to Rachmoninov? People are better than me at specific things, I am better than them overall. It's simple, really. If your reality in it's present condition as a human being is good enough for you and you are contented with it than I am automatically better than you are. I'm single-handedly doing everything I can think of to usurp, overthrow, or otherwise undermine you. I'm comfortable with my position as 'fully hostile', and so should you be. It was your conditions which defined me. Just think of me as a 'souper', 'super'.

 

[Bronze]

Anna suddenly makes total sense to me.

 

[puffon]

Sometimes when the wind is just right, I can stand outside my home and smell the roadkill from here all the way to the next town. You can't express the inexpressible. Why demand it? So you can mock the futility of grandiosity? Why not listen to Rachmoninov? People are better than me at specific things, I am better than them overall. It's simple, really. If your reality in it's present condition as a human being is good enough for you and you are contented with it than I am automatically better than you are. I'm single-handedly doing everything I can think of to usurp, overthrow, or otherwise undermine you. I'm comfortable with my position as 'fully hostile', and so should you be. It was your conditions which defined me. Just think of me as a 'souper', 'super'.

There is a forum for you:
https://www.e-cigarette-forum.com/forums/outside.49/

 

[CublalaLand]

There's not anything for me there. I'm not interested in politics. I've never done the wrong thing just so I could beg forgiveness, later. There's nothing in the human syndrome that interests me. I was born on bread and circuses, by people who seek nothing more than idle entertainment.

 

[classwife]

Enough of the derailing
Thank you

 

[CublalaLand]

We're on track, right here. The FDA ban is idle entertainment for us, vapers. Politicians reaching into people's lives to directly interfere in any way they possibly can, just to mess them up. It's all tied to the same thread.

It's bread and circus shows for people who want nothing more than idle entertainment.

 

[Hoggy]

So there's a 10 month window for filing PMTA's and another year after that for those who filed awaiting approval. Is my understanding correct?

I know, someone finally asks a question that's in absolute direct relation to the exact title of this thread - and they go unanswered!

I'd answer, but I have no clue.

 

[Buckeyevapen]

I know, someone finally asks a question that's in absolute direct relation to the exact title of this thread - and they go unanswered!

I'd answer, but I have no clue.

Definitely the 10 months. And the original deeming had language regarding the 1year while the PMTA is reviewed. However to put a PMTA together requires millions and millions of dollars for the company so in many ways 10 months is hard deadline.

 

[stols001]

I kind of look at that kid as verbal performance art; I am NOT asking it to cease, in fact I think he could get a book contract. I would read it.

As far as "other stuff" um, "other stuff" does not make SUDDENLY STOP craving nic, if anything it makes it worse.

Also, after encountering it as a more elderly person.... I become ENTIRELY non functional and by that I could burn the house down. I use it for pain control when I absolutely HAVE to but in no way is it a substitute for nicotine. Nicotine makes me a HELL of a lot sharper and snus makes me a HELL of a lot more CHILL.

Substitution for "other stuff" is not possible for some, and I am a part of that some.

The very idea is ludicrous-- I did not decide to give up on Suboxone but getting myself a nice little coke habit to beat it. That is NOT how it works. IF you REALLY think so give up your nic for a day and just vape the "other stuff" and if you haven't for a while, kindly don't drive.

Addiction== the right brain, meets the right drug. I do not plan to treat my nicotine addiction with the famous leaf. I'm sorry it would not work and when I say NONFUNCTIONAL I mean I need a keeper.

@Bronze, I'm so glad my wisdom has become clear to you now. Your wife? Is it? I think? Thanks you. God unless she's relentlessly capable and logical like you. That would be terrifying.

I figure the non impaired should do the impaired a favor and marry one of THEM. That's what the husband did.

While he has made several unkind statements from time to time he has never actually regretted it.


Anna

 

[Doffy]

So there's a 10 month window for filing PMTA's and another year after that for those who filed awaiting approval. Is my understanding correct?

i think so

but, some will be rejected during that one year. So no longer awaiting approval

maybe some accepted, hopefully

on a related note. I've heard figures thrown around for cost of a pmta ranging from "tens of thousands" to "millions and millions"
is this because something like eliquid might be a simple one, and other products orders of magnitude more?
or is it just that people use random high figures, with no actual clue?

 

[Rossum]

I know, someone finally asks a question that's in absolute direct relation to the exact title of this thread - and they go unanswered!

Sheesh, that was only about 90 minutes ago.

So there's a 10 month window for filing PMTA's and another year after that for those who filed awaiting approval. Is my understanding correct?

More like 9-1/2 months now. Any products for which no PMTA has been filed by May 12th (or thereabouts) will technically be illegal to sell or distribute.

Once a PMTA is filed, the FDA has stated it will allow another year on the market while it evaluates the PMTA. This doesn't make a whole lot of sense to me since statute law requires them to act on a PMTA within 180 days. Reality is the two PMTAs that have been approved so far (one for Snus, the other for IQOS) were under evaluation for several years. I guess nobody is willing to hold the FDA's feet to the fire via the courts about the 180 day statutory deadline since the likely result would be the FDA saying: "OK, if we have to decide now, we'll deny approval".

My guess on how this will shake down is that for products that have decent PMTAs filed: The FDA will allow them to remain on the market for however long it takes them to "evaluate" the PMTAs, which will probably be longer than one year.

The big question is: What will the FDA do about all the products for which no PMTA is filed? They simply do no have the resources to go into every vape (and smoke/vape) shop in the country to check what's being sold there. How motivated are they to put a lot of effort into enforcement? My guess is that they are not terribly enthusiastic about it due to having the deadline forcibly pulled forward by a court.

 

[Rossum]

on a related note. I've heard figures thrown around for cost of a pmta ranging from "tens of thousands" to "millions and millions"
is this because something like eliquid might be a simple one, and other products orders of magnitude more?
or is it just that people use random high figures, with no actual clue?

Well the FDA itself estimated it that an acceptable PMTA would cost ~$330,000. I don't remember the exact figure by I'm confident that's within +/- 10%. Most people in the industry thought that estimate was low, perhaps by an order of magnitude. The two PMTAs that have been approved so far ran into the hundreds of thousands, if not a couple of million pages. So if you assume $1/page (which strikes me as low), well... Nope, I just don't see how "tens of thousands" is remotely plausible.

 

[Hoggy]

Sheesh, that was only about 90 minutes ago.

Well, I currently have pneumonia - so I have an EEEXXXcellent excuse(s) for being loopy and time-dilated.
So what is your excuse for waiting, like, 90 HOURS to reply then, huh?

 

[dreamvaper]

There isn't anything visibly mentally, or physically wrong with me.

what a coming out, dude
btw, that's what happens when you spend most of your time talking to your smart fridge!

 

[dreamvaper]

I currently have pneumonia

are you sure it's not the "popcorn lung" - the case they were looking for so long?

 

[ScottP]

Since Day 1, I have said that I Don't Think the FDA wants to Ban e-Cigarettes. I still hold that Belief.

And I have said Many Times that it Isn't the Banning of e-Cigarettes, It's the Banning of who is Allowed to Produce and Make Profits via the e-Cigarette Market.

The FDA/Government wants a handful of Players who control the Entire Market.

It Simplifies the Administrative Burden of Regulation.
It Centralizes the Distribution of Profits/Campaign Monies.
And it Maintains a Vehicle for Taxation. Both at the Federal and State Level.

There is going to be e-Cigarettes. They are just going to Look all like a Vuse or a Pod Mod.

And the Number of Companies that produce them will be able to be Counted on One Hand. Just like e-Liquids.

I agree but that is what really pisses me off. The government should NEVER be in the business of "picking winners and losers" in the private sector.

 

[ScottP]

The big question is: What will the FDA do about all the products for which no PMTA is filed? They simply do no have the resources to go into every vape (and smoke/vape) shop in the country to check what's being sold there. How motivated are they to put a lot of effort into enforcement? My guess is that they are not terribly enthusiastic about it due to having the deadline forcibly pulled forward by a court.

For most shops the mere threat of being shut down will be enough to get them to not sell those products. There will be some that wait until a couple of shops have been shut down to stop. Then there will be a very small minority that do manage to fly under the radar.

 

[Rossum]

For most shops the mere threat of being shut down will be enough to get them to not sell those products. There will be some that wait until a couple of shops have been shut down to stop. Then there will be a very small minority that do manage to fly under the radar.

I do not think that shops get "shut down" for the first violation. My impression is the first violation results in a warning letter, and the second in a relatively small fine. Are you aware of any stores that have been shut down due to selling tobacco products to minors?

 

[Eskie]

The FDA did leave in an option to review a given product at a later time to be decided on a case by case basis, as well as waiving withdrawl from the marketplace if say you expect to file one PMTA and a bunch of SEs based on an initial approval. I expect if you show good faith in attempting to complete a PMTA but don't have it all together by the cutoff date you might get an extension. They also set out more concrete guidelines on what they'll accept. This includes stuff like a UL listing for electrical safety.

Among the most important, the health data, which can run major figures if you have to do it yourself, can be satisfied with a review of the scientific and medical literature to submit in its place. This can mean running toxicity tests on vapor and then using already published work, including OSHA regulations on exposure to say formaldehyde, to support a marked decrease over combustible tobacco.

They also state that if you're making juice and use ingredients off the master ingredient list, no idea what's on it, you can use that to simplify the application as well as keep proprietary formulas private. None of it will necessarily be easy, but it's not as onerous as the vague and scary looking requirements announced back in 2016. Of course viewing what's approved and what's denied will be the real test to see how it shakes out.

I also believe if you get a PMTA on say a mod, so long as the electrical components like the board are used in a different box for design change ups an SE application would be sufficient. If a board like say a DNA board from Evolv, who already have put a lot of work into getting their components approved, you ma well be able to simply file an SE so long as you follow the rest of the specs for wiring it up. That too will decrease costs to the company.

Of course all these expenses will be passed along to use, the consumer, through higher prices on the approved products to make up for the expenditure in obtaining approval in one form or another.

 

[MyMagicMist]

So what is your excuse for waiting, like, 90 HOURS to reply then, huh?

@Rossum was busy looking for mason jars full of cash I've possibly hidden on his property. I'm hiding some there and on another friend's place. For some odd reasons spamers are paying me now and well I'm starting to sink in cash.

I could only wish.