Deeming Regulations have been released!!!!

[mcol]

It literally takes a couple minutes, if that, to sign up on twitter

Takes about 5 seconds to tweet to them, depending on how fast you can type.

 

[The Ocelot]

Speaking of, what we really need is John Oliver to do a segment on this. In fact, I'd say his show is the single best thing that could happen at this point. His show hits the exact demo that we need, and Washington takes notice when he does a segment. My two cents- I think everyone should put their efforts into trying to get one show/person to address it instead of spreading out the efforts.

But again- we need a leader. Waking up on day 5...I cannot fathom how there is not someone rallying everyone to a single action yet. I think we need to elect Phil Busardo as our president first, and go from there. That's my vote anyway. Let's get him out of his day job and put him to work full time on this. We need a leader who can inspire everyone, and I can't think of anyone better for the job.

I think John Oliver would be great too, but it appears his show has a long lead time.

 

[sparkky1]

Ok maybe I am being naive, but I was kinda sorta counting on CASAA and my marching orders, give or take a RAMdom emailing of local representitives.

We will be going to court, but it's going to cost, so my thoughts were to get the "stars" on board to possibly help

 

[drysprocket]

Ok maybe I am being naive, but I was kinda sorta counting on CASAA and my marching orders, give or take a RAMdom emailing of local representitives.

Yeah, you're right. And I'm not saying that we shouldn't wait for them. I'm just saying we also need a single person with reach to coordinate everything else. Waiting on an organization just doesn't seem like enough in my view. There are tons of things we can do aside from the official things that CASAA will likely direct us toward.

Just feels a bit like we're moving toward an Occupy Wallstreet model at the moment. That was a perfect example of what happens when a movement tries to form without a figurehead. In fact....I had to google the name of them just know. I somehow forgot the name of a once 'huge' movement. Despite all of their efforts, they are now a fart in the wind. We should try to learn from their mistakes.

 

[sparkky1]

Just to let you know, I don't do social media ( besides vapor ) at all.
Until last week !!!

 

[bobwho77]

this is bad but take just an average economic juice company like dr crimmys for instance or one of the others. or take a major juice company like g2 for years they have made boatloads of profits maybe even enough to afford the million dollar license. delivery systems regulation is what is gonna be the problem. but they will find ways around that given time. and if given license I see no problem with using fda approved flavorings or vg/pg and would actually prefeer lab standerds and inspection. I think many juice companys will survive and as for the hardware go out and buy some mech mods.

The regulations aren't providing a blanket license at a set price. They're requiring an application, and testing data for EVERY formulation of EACH flavor, at EVERY nic level.
Mt. Baker Vapor makes juices at 5 different VG/PG ratios, and 6 different nicotine levels. These regulations will require $30 million in testing, and application fees for EVERY flavor! How many flavors do they make?
Stop acting like the North end of a Southbound horse!

 

[DC2]

I do wonder what their criteria is for approving a PMTA application.

Well then, you might want to glance through here...
Premarket Tobacco Applications
Here's a fun nugget to get you started...

Premarket Tobacco Applications must provide scientific data to demonstrate that the new tobacco product is beneficial to the population as a whole including users and non-users. This demonstration shall take into account the increased or decreased likelihood that existing tobacco users will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using them.

 

[sparkky1]

The regulations aren't providing a blanket license at a set price. They're requiring an application, and testing data for EVERY formulation of EACH flavor, at EVERY nic level.
Mt. Baker Vapor makes juices at 5 different VG/PG ratios, and 6 different nicotine levels. These regulations will require $30 million in testing, and application fees for EVERY flavor! How many flavors do they make?
Stop acting like the North end of a Southbound horse!

Let me help spell it out, so we don't have to get any one else, anymore upset than they already are
The Rest of the Story: Tobacco News Analysis and Commentary: FDA Draft Guidance Confirms that Deeming Regulations Will Decimate the E-Cigarette Industry

 

[mudram99]

Yeah, you're right. And I'm not saying that we shouldn't wait for them. I'm just saying we also need a single person with reach to coordinate everything else. Waiting on an organization just doesn't seem like enough in my view. There are tons of things we can do aside from the official things that CASAA will likely direct us toward.

Just feels a bit like we're moving toward an Occupy Wallstreet model at the moment. That was a perfect example of what happens when a movement tries to form without a figurehead. In fact....I had to google the name of them just know. I somehow forgot the name of a once 'huge' movement. Despite all of their efforts, they are now a fart in the wind. We should try to learn from their mistakes.

I feel your frustration! And am doing what little my feeble nic induced mind is offering me as opportunities, so far some great suggestions have come from right here. At least until we are ordered to lock N load!

 

[Pamawoman]

Below is the response I received from my state senator this morning -


May 9, 2016



Dear Ms. XXXXXXX,

Thank you for sharing your concerns with me about the Federal Drug Administration's (FDA's) newly proposed "grandfather date" regulation for tobacco products. Your letter contained language very similar to many other letters and emails, which might have even been generated from an advocacy group on your behalf. Every letter from an Oklahoman is important to me, and I am happy to know the opinion of so many Oklahomans.

As you may know, on April 24, 2014, the FDA released "deeming" regulations to use a February 15, 2007 "grandfather date" to include cigars, electronic cigarettes, and other tobacco products under FDA authority. Before February 15, 2007, many tobacco products, including cigars, were not available for regulation. Electronic cigarettes were not considered tobacco products until 2011. Many critics of the FDA's rule argue that applying FDA regulations to cigars and electronic cigarettes under the February 15, 2007 rule would be devastating to private businesses and would ban a significant number of electronic cigarette products that millions of consumers use to remain smoke-free. On May 5, 2016, the FDA announced its finalized rule to the deeming regulations, which you can read more about here.

As an advocate for limited government, I support the right of private businesses to limit tobacco use in and reasonably around their premises. States and localities should also have the full authority to restrict smoking and tobacco use within their borders. I also support policies that remove federal regulatory barriers in our free-market economy and give citizens as much control of their own lives and the lives of their families as possible. This retroactive regulation of tobacco products by the FDA, including the selection of a date for some products that precede their invention, is unfair and unacceptable.

On April 28, 2015, Rep. Tom Cole (OK) introduced H.R. 2058, the FDA Deeming Authority Clarification Act. If enacted, H.R. 2058 would amend the Federal Food, Drug, and Cosmetic Act to change the grandfather date of newly deemed tobacco products to the date when the FDA's "grandfather date" regulation is finalized. This would mean that hundreds of electronic tobacco brands and the dozens of private businesses that sell these products would be able to stay on the market with very minimal changes and at a significantly lower cost. H.R. 2058 has been referred to the House Committee on Energy and Commerce, where it awaits further action. Currently, no Senate companion bill to H.R. 2058 has been offered. I will keep your thoughts in mind, if legislation about this regulation comes to the Senate floor for a vote.

Please feel free to contact me again via email at www.lankford.senate.gov for more information about my work in the United States Senate for all of us.



In God We Trust,

James Lankford
United States Senator

Wow. You have a senator with a brain! I wish I did. I just get back noncommittal emails.

 

[The Ocelot]

Yeah, you're right. And I'm not saying that we shouldn't wait for them. I'm just saying we also need a single person with reach to coordinate everything else. Waiting on an organization just doesn't seem like enough in my view. There are tons of things we can do aside from the official things that CASAA will likely direct us toward.

Just feels a bit like we're moving toward an Occupy Wallstreet model at the moment. That was a perfect example of what happens when a movement tries to form without a figurehead. In fact....I had to google the name of them just know. I somehow forgot the name of a once 'huge' movement. Despite all of their efforts, they are now a fart in the wind. We should try to learn from their mistakes.

I think a natural leader will become apparent. Phil's a great guy, but we need someone with more credibility than a youtube reviewer.

Another person I'm surprised I haven't seen in the media is John Cameron. He's kind of a snake, but he had that IMPROOF thing going on for awhile.

 

[WillyZee]

NJOY coming out with that Artist Collection line of juice, is starting to make sense now.

It might end up being one of the only juice lines not owned by BT.



Sent via iPhone

 

[skoony]

The live active link to this thread has been removed.
I found a working link in this post.
never mind thats gone too.
mike

 

[ZeroedIn]

Unfortunately I don't think her story is that unusual. There have to be thousands who are simply oblivious to what is happening.

THIS ^^^^^^^^^^^^ is what "they" are counting on.

 

[Spazmelda]

Let me help spell it out, so we don't have to get any one else, anymore upset than they already are
The Rest of the Story: Tobacco News Analysis and Commentary: FDA Draft Guidance Confirms that Deeming Regulations Will Decimate the E-Cigarette Industry

That puts it in perspective. These regulations are totally impossible. Is there any other product/industry held to such a standard? My husband is in OTC drugs, and I don't think their regulations are even this insane. Then, suppose you do your best to jump through these hoops and the FDA either sits on your submission indefinitely or just says, "nope". Litigation is the only way through this. Total insanity.

 

[sparkky1]

I think a natural leader will become apparent. Phil's a great guy, but we need someone with more credibility than a youtube reviewer.

Another person I'm surprised I have seen in the media is John Cameron. He's kind of a snake, but he had that IMPROOF thing going on for awhile.

Well what do they say, to catch a snake, you have to ?
Only in America can you run for presidency and be in court for RICCO act on the same day ..............

 

[Bronze]

Pefect
Stick with zeller then ..............

I guess you never learned in life that most things are not either/or. Might be beneficial for you to have mom and dad re-teach you some life basics.

 

[drysprocket]

I think a natural leader will become apparent. Phil's a great guy, but we need someone with more credibility than a youtube reviewer.

Another person I'm surprised I have seen in the media is John Cameron. He's kind of a snake, but he had that IMPROOF thing going on for awhile.

I hear ya, a youtubber by definition wouldn't be my first go-to. But Phil has reach with his viewers, is well connected with companies, is inspiring/persusaive, and is respected by the community. I can't think of anyone else who checks all the boxes. Just saying...he's sorta perfect

 

[mcol]

Not sure if this was posted, too many things going on.
But there's a webinar on this right now, started a half hour
ago. With Dr. Siegel.
Welcome! You are invited to join a webinar: E-Cigs DeMISTified: FDA Deeming Regulations Update. After registering, you will receive a confirmation email about joining the event.

 

[bigdancehawk]

The documentary project "A Billion Li(v)es" was not publicly funded, and the production company does not have the capital for self promotion and distribution. In order to reach the general public, they need to get the film promoted where the general public can and will hear about it and view its content. Film festivals are the first step in this process to get the promoters interested in the project. Once the promoters are interested, they work with the production company to line up distribution and get the movie theater companies interested in showing the film.

If this production company were to give up on this process and just release the film (at a financial loss to themselves), it might be a great feel-good moment for them, but it would not reach general audiences around the world. The only people viewing this documentary (on streaming services) would be people who already have an interest in the topic, so they would essentially be "preaching to the choir". If this documentary does not receive at least minimal distribution through normal channels, it will have been a complete waste of time and money, and accomplish absolutely nothing.

This is the producer/director's first attempt at this sort of thing. LINK

I know a little bit about independent film making. My best friend, who is also a client, has been making documentaries for decades. His films have been on nationwide PBS multiple times and he's produced and directed signature films for Detroit and Kansas City. He's been nominated for a couple of Emmys. He currently has a feature length IMAX documentary that's in distribution nationwide.

My son-in-law has a masters degree in film directing from CalArts, one of the top schools. He is currently a full time filmmaking professor. He's made a number of short films and a feature theatrical production, none of which have made any money.

With virtually no exceptions, independent film producers don't make any money, especially on their first attempt. So they try to get their films into festivals, not because festivals are profitable (they aren't) or result in distribution contracts (they don't), but rather because they hope to get the attention of people who might be convinced that they have the requisite talent and motivation and who might be willing to finance future film ventures.

Almost 10,000 short films are submitted to Sundance every year. Only about 65 are selected. Very, very few of those will actually produce significant revenue. It's not at all unusual for a film to be shown at dozens of festivals all over the world and never make a dime. In fact, this is what typically occurs.

So, regarding A Billion Lives, don't hold your breath. IMO, while this is a hot topic, they should put it on YouTube and hope somebody with money to invest will see it and back their next project.