Deeming Regulations have been released!!!!
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No Donnie sychophant has a job now, and they won't, except for Dancing On The Stars, because other then a long history of bankruptcy and running up our debt too, the celebrity apprentice was nonsense. He was never a master mind, he was just good at conning people who wanted to hear what they wanted to hear.
Work for him if you can that will be the end of your career. I don't, won't and know better.
Work for him if you can that will be the end of your career. I don't, won't and know better.
Still confused, not uncommon in my life, especially lately.
The republicans controlled the senate, the house of reps, and the WH, were all controlled by republics for 8 years before Obama showed up, and then the April 2008 recession killed us. Obama was not in charge.
Trump hired Larry Kudlow, an economic genius who managed to completely tell us there will be no recession - fail, but he is a good T fan boy.
Then lets blame Obama for inheriting the mess, might as well blame the fire fighters for the fire too. It's their fault saw them there while the fire blazed. Yes it took 8 years to recover from that recession.
These are the facts and timelines, the real truth, and why I watch news orgs that point out these historical facts and why I don't watch Fox.
So complaints about mis-information about vaping from people who prefer mis-information? Really?
Trump hired Larry Kudlow, an economic genius who managed to completely tell us there will be no recession - fail, but he is a good T fan boy.
Then lets blame Obama for inheriting the mess, might as well blame the fire fighters for the fire too. It's their fault saw them there while the fire blazed. Yes it took 8 years to recover from that recession.
These are the facts and timelines, the real truth, and why I watch news orgs that point out these historical facts and why I don't watch Fox.
So complaints about mis-information about vaping from people who prefer mis-information? Really?
I have read the 339 pages, plus some of the additional docs being contemplated.
Am I wrong about any of the points below.
Essentially a PMTA is asking permission to bring a product to market
Nothing in the Deeming:
Nothing gives them authority for search and seizure of personal property.
Nothing gives them the authority to fine or tax property you already own.
Those who choose to stock their larders will have no legal issues whatsoever.
Those who dont will have to accept whatever the FDA approves, or go underground if they choose to continue to vape.
Am I wrong about any of the points below.
Essentially a PMTA is asking permission to bring a product to market
Nothing in the Deeming:
- Prohibits possession in any way
- Prohibits making hardware or juice for yourself.
- Prohibits vaping any style, flavor, or strength you like
Nothing gives them authority for search and seizure of personal property.
Nothing gives them the authority to fine or tax property you already own.
Those who choose to stock their larders will have no legal issues whatsoever.
Those who dont will have to accept whatever the FDA approves, or go underground if they choose to continue to vape.
The sad thing is look at the percentage of republicans who blame obama for hurricane katrina too, despite he was a senator for a state far away and wasn't president until 3 years later, but it's clear, republicans don't care about facts, history, they just want to trump worship, blame hillary and obama.
yes republicans really do blame Obama for Hurricane Katrina, really really, not the smartest people. The same post modernism make up reality snow flake truths, even worse at times.
yes republicans really do blame Obama for Hurricane Katrina, really really, not the smartest people. The same post modernism make up reality snow flake truths, even worse at times.
Somebody Needs a Timeout.
Or to Put the Bottle Down.
Or Both.
Or to Put the Bottle Down.
Or Both.
Thank you for reading all that, Mike.
This is the smartest thread on upcoming regs I know, so I will post it here.
It could be uncontrolled idiocy or pure genius, but I wonder if there is a way to turn vaping into a religion. I really kind of do.
Fight puritanism with a zany sort of religious spirit of joy, and like, our establishments would be tax free even.
I think like the true OWNERS of this country use tobacco in religious ceremonies and like, well to be FAIR, look what happened to them? But American Indians are legally allowed to smoke peyote for example (okay to be fair, they also have their own laws.)
I am thinking, in a sort of high tech way, we could go sort of um, in the honor of the inventor, well like, we could go from an Asian Religion angle.
I'm just sort of wondering what would be needed, like, legally. Obviously, there would have to be some dogmatic text, but that's easily written. Practical dogma like battery safety never goes amiss (the 10 commandments of Mooch for example.)
I mean, freedom of religion is why EVERYONE came here, is it not? I think in some ways a religious angle (in court) is one of the hardest to fight.
There are ZERO persons that can prove, or disprove that vaping helps strengthen your Qi.
But that's the whole thing, that's why religions WIN in court so many more times than not, how do you disprove FAITH? You really can't and freedom to worship at the altar of ones choice is at the VERY HEART of America, right? Hence the Separation of Church and state.
I may be nuts (okay I am nuts, and prepared to decrease the antipsychotics a bit for awhile here, if you want parts of the creed to sound TRULY authentic, I mean, I'd have to write psalms.
But lets face it, if vaping is the central and only way that we can worship at the Great Harm Reducer in the sky, we don't have to pay taxes even. Everyone's fighting law vs. stockpiling vs. everything else.
L. Ron Hubbard did it and while he sort of started smaller, what if any and all vapers were willing to sign a religious petition? Not only could we buy our vape supplies from the great makers of the East, the pioneers of our Spiritual and Religious movement, we could have Harm Reduction stores, tax free, with which to purchase our flavorful nicotinic personal like, incense swinging miters and well, associated whatever because we all know true believers practice their faith at home.
I just.... I'm getting so sick of fighting insanity with sanity.
If you ask me, if there is anything that would make our politicians BLANCH it would be THAT. The only think more sacred that the children in this country is religion.
IDK I wonder if anyone has even proposed this? I need smart advice on how it could actually WORK, what you have to do to declare yourself a religious entity and how long it takes to decide whether something can be "legal" or not based on a long standing and ever growing movement of people who are committed to something RELIGIOUSLY because it reduces harm.
Hmm. Need a good lawyer or two. Chime in. I could ask my sis, I guess, she works for a judge on the 9th circuit (he's republican, she's a democrat.)
Anna
It could be uncontrolled idiocy or pure genius, but I wonder if there is a way to turn vaping into a religion. I really kind of do.
Fight puritanism with a zany sort of religious spirit of joy, and like, our establishments would be tax free even.
I think like the true OWNERS of this country use tobacco in religious ceremonies and like, well to be FAIR, look what happened to them? But American Indians are legally allowed to smoke peyote for example (okay to be fair, they also have their own laws.)
I am thinking, in a sort of high tech way, we could go sort of um, in the honor of the inventor, well like, we could go from an Asian Religion angle.
I'm just sort of wondering what would be needed, like, legally. Obviously, there would have to be some dogmatic text, but that's easily written. Practical dogma like battery safety never goes amiss (the 10 commandments of Mooch for example.)
I mean, freedom of religion is why EVERYONE came here, is it not? I think in some ways a religious angle (in court) is one of the hardest to fight.
There are ZERO persons that can prove, or disprove that vaping helps strengthen your Qi.
But that's the whole thing, that's why religions WIN in court so many more times than not, how do you disprove FAITH? You really can't and freedom to worship at the altar of ones choice is at the VERY HEART of America, right? Hence the Separation of Church and state.
I may be nuts (okay I am nuts, and prepared to decrease the antipsychotics a bit for awhile here, if you want parts of the creed to sound TRULY authentic, I mean, I'd have to write psalms.
But lets face it, if vaping is the central and only way that we can worship at the Great Harm Reducer in the sky, we don't have to pay taxes even. Everyone's fighting law vs. stockpiling vs. everything else.
L. Ron Hubbard did it and while he sort of started smaller, what if any and all vapers were willing to sign a religious petition? Not only could we buy our vape supplies from the great makers of the East, the pioneers of our Spiritual and Religious movement, we could have Harm Reduction stores, tax free, with which to purchase our flavorful nicotinic personal like, incense swinging miters and well, associated whatever because we all know true believers practice their faith at home.
I just.... I'm getting so sick of fighting insanity with sanity.
If you ask me, if there is anything that would make our politicians BLANCH it would be THAT. The only think more sacred that the children in this country is religion.
IDK I wonder if anyone has even proposed this? I need smart advice on how it could actually WORK, what you have to do to declare yourself a religious entity and how long it takes to decide whether something can be "legal" or not based on a long standing and ever growing movement of people who are committed to something RELIGIOUSLY because it reduces harm.
Hmm. Need a good lawyer or two. Chime in. I could ask my sis, I guess, she works for a judge on the 9th circuit (he's republican, she's a democrat.)
Anna
I think that could work. The thing is that it would have to be classified as a religion, and not as a cult. To do that it would require a large number of people to proscribe to it's tenets. I'm not sure how many people would be willing to forsake Jesus, Allah, Yahweh, Shiva etc. just to vape legally. Some would for sure, but how many, and would it be enough? IDK, interesting possibility though. Maybe it could be like Buddhism, where you can be Christian and Buddhist at the same time? Nice thought Anna, let me know what you think.
Nah I heard the MJ folks tried it and failed. And they don't even have/had the MENACING specter of BIG HEMP to fight. It's sad, but true.
Anna
Anna
I haven't. I admit.
But I think you're right. What I'm still not clear about:1. Grandfather date. I know that the FDA said a long time ago that they can't change the date (only Congress can do it). So if the February 15, 2007 date still stands, will all hardware not in existence at that date (no predicate) be removed from the market? That's pretty much 100% of everything we're using today.
2. Flavored eliquids? They were being imported in 2007, I'm pretty sure of that. Do they have to be grandfathered? If so, which ones? What's the predicate?
I haven't. I admit.
1. Grandfather date. I know that the FDA said a long time ago that they can't change the date (only Congress can do it). So if the February 15, 2007 date still stands, will all hardware not in existence at that date (no predicate) be removed from the market? That's pretty much 100% of everything we're using today.
2. Flavored eliquids? They were being imported in 2007, I'm pretty sure of that. Do they have to be grandfathered? If so, which ones? What's the predicate?
I dont see anything that changes that predicate date, which pretty much eliminates the "substantially equivalent to a predicate tobacco product" pathway for most vape stuff. A few Chinese companies might be able to show "substantially equivalence" like perhaps DeKang eliquid, if they kept good enough records.
Nothing says that you cant submit a PMTA for a "NEW Tobacco Product" though.
"The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act)
provides FDA with the authority to regulate tobacco products under the FD&C Act. The FD&C
Act, as amended by the Tobacco Control Act, generally requires that before a new tobacco
product may be introduced or delivered for introduction into interstate commerce, it must
undergo premarket review by FDA. Section 910(a)(1) of the FD&C Act defines a “new tobacco
product” as: (1) any tobacco product (including those products in test markets) that was not
commercially marketed in the United States as of February 15, 2007; or (2) any modification
(including a change in design, any component, any part, or any constituent, including a smoke
constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of
a tobacco product where the modified product was commercially marketed in the United States
after February 15, 2007"
"If finalized, the proposed
rule would interpret and set forth requirements related to the PMTA premarket pathway and
outline the information needed for FDA to determine whether it will issue a marketing order
under the pathway."
Most of the 339 pages defines the scope of what would required to submit a PMTA for NEW tobacco product. About 2/3 of the document is directly related to vaping, and about 1/3 for all other types of tobacco products.
They do allow "bundled PMTAs, which are single submissions containing PMTAs for a number of similar or related tobacco products". This could be used for introducing something like 6 mods that were all alike except for color or shape, as long as the aerosol profile (and abuse potential) was identical for all of them.
As I mentioned before, this scope of requirements represents Millions of $$ worth of work if you want to stand a prayer of getting approved. The FDA states that "FDA developed Form FDA 4057 for use when submitting PMTA single and bundled submissions. FDA estimates that 24 respondents will submit PMTA bundles using this form" of which they estimate only 25% will be approved.
They also allow "bridging" of data.
"If an applicant lacks data on the product from one or more of the types
of studies listed in this section, the applicant could bridge data regarding another product, or an
earlier version of the product where appropriate. For example, “X-flavor” e-liquids with nicotine
concentrations ranging from 1 milligram per milliliter (mg/mL) to 24 mg/mL may be able to
show the health risks of each of the e-liquids without having to conduct a unique study for each
nicotine concentration of the “X-flavor” product if data from a subset of nicotine concentrations
(e.g., low, middle, high) of “X-flavor” products may be bridged to other nicotine concentrations
of “X-flavor” products."
This means they could do the studies on one strength of a particular flavor and extrapolate the data to cover an assortment of strengths. However "FDA recommends that the application contain the rationale and justification to support the use of bridging studies."
Okay so on topic then...
My family was OMG vaping kills people, saw it on the news, so it must be true! Just more head banging. I tried to explain vaping had nothing to do with the recent run of illness, but nope, fail. They saw a report on vaping and teens and that is that, so getting into PG, VG, nicotine, vs THC and oil was pointless.
So I am going to try to send a message to my reps again, but this time less about facts, and more of an emotional appeal. Facts can be counter productive.
My family was OMG vaping kills people, saw it on the news, so it must be true! Just more head banging. I tried to explain vaping had nothing to do with the recent run of illness, but nope, fail. They saw a report on vaping and teens and that is that, so getting into PG, VG, nicotine, vs THC and oil was pointless.
So I am going to try to send a message to my reps again, but this time less about facts, and more of an emotional appeal. Facts can be counter productive.
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