Deeming Regulations have been released!!!!
- Thread starter Oliver
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The feb 2007 date will preclude all regulated mods.
We still seem to be ignoring that....
The way it seems to me right now as the current rules stand pretty much only cigalikes will survive the PMTA process.
Federal laws and regulations always superceed state laws. The Constitution isnt worth the paper its written on. I know people want to believe in it, and freedom, but it has long been an illusion. We gave all that up long before the Patriot Act ever came along. Short of total revolution nothing is going to change it. Capitalism as the great american expiriment has failed into oligarchs and class separation. And yes, again, I am a republican.
On another note, the scourge of New York, Chuck Schumer went out to media outlets today saying that the FDA needs to investigate all the cases of "exploding ecigarettes" in New York because in most cases it is teens that get hurt.
I had links to articles but cant figure out how to break the links. Here is the 1st politican seeking press off the fda regs. Leave it to Schumer.
Please someone tell that P.O.S. to shut up. If I call his office Im liable to end up in jail. He jumps on every damn bandwagon he can and its absolutely disgusting.
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CRA! You obviously know more than most. Ironically, CRA requiements were a profit center because we sold them all to Fannie/Freddie within a week after they funded. The GSE's wanted those loans and marketed to us and for us for those originations.
The real similarity is the wild west aspect. I witnessed it up close and personal then and now. Both are poised to suffer the same fate. The only winners are big business and the losers are everone else. Both the small businesses and consumers get shafted once again. I'm having the sudden urge to start kicking random things in the house again...
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I agree. I posted something earlier about this but will mention again.....What I believe needs to be done is that ALL politicians need to be informed immediately of what the FDA and BT are up to. Why?
Guys, I (and I hope all of you) have been fighting hard for 3-4 years now at the State level NOT to tax our vaping products (and those of you who have, know that the suggested tax to ml ratio is absolutely horrifying).
States HAVE actively or WILL actively TAX vaping. The FDA and BT with their underhanded sneaky handshake, have effectively pulled employment, State sales tax AND the current or future sin tax rugs from right under the State representatives, is going to cause an uproar.
Maybe CASAA? - or we? - is/are need to ensure every senator and politician SHALL be made aware of this. I don't know.
The DOWN side: What ticks me off so bad, is the knowledge that we can see the "Yes! Let's tax us!" trap right under feet and yet have to deliberately fall in and actively warn the corrupt but ignorant nitwits at political levels, what the FDA is up to - just to be paid back with huge sin taxes ultimately. The best this will achieve is that the deeming will be through 2016 nd keep our current euipment and juices legal.
The DOWN side being that we will be taxed heavily on the products, and while all of you will make your own individual decisions in this regard, I personally am getting as big a stash of vaping supplies as I can afford pre-sin-tax, and nicotine for freezing right now. And then I can remain faithful to my most favorite juice vendors later, taxes included, because all this is going to boil down to ..... money.
I've thought about that also. Especially since from what I've read, cigalike sales have dropped dramatically.
Another thought is, with only cigalikes in the market, many people won't be able to quit with them, then the government will say, "See, they aren't an effective way to quit smoking."
The FDA is writing it's own law zero. The Pres and Congress gave 'em an etch-a-sketch. Court told 'em no mas but they keep stretchin' the screen. They're off the grid bakin' they're own birthday cake. So there's no real tellin' where we go from here. Don't think the politico's are much scared of signatures. But they hate interviews requiring answers. A million of 'em ought to do right about now. Me I'd send 'em home and shut down the party but there's a constitutional amendment in the way.
Good luck all.
No, of course not. I'm asking about the unconstitutionality of the regulations, especially because likely all states have laws on their books already prohibiting the sale of nicotine products to minors.
I've read the whole thing and all the references to earlier legislation. It took a while
I know the detail the of the three main 'tests' you had to do for a good bank examiner's grade and not to have Acorn or Rainbow outside your building protesting.Only after many banks protested and the 'gov't solution' was for Freddie and Fannie to take them off your plate, making it easier for you to make loans you wouldn't have normally made. :- )
No more on this here though.... PM if you wish....
It is no wonder why other countries laugh at America. [Other Stuff] is legalized in some states, life saving devices are given a death sentence, and the leaders in this country are in some serious need for adult supervision. This country is not what it was unfortunately, we were all thrown under the bus long ago. Makes me want to become a hermit......oh...wait, I think I may already be. crap.
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Have you asked this guy, what he thinks about the new regs ?
Corey Lewandowski (@CLewandowski_) | Twitter
I'm probably wrong, but how I'm reading it is the 2007 predicate date is for products to try for "substantial equivalency (SE)" or "SE Exemption." A PMTA is required for products manufactured after the predicate date. Covered products currently on the market must go through the PMTA process to remain on the market. New products may not be sold without FDA approval, but they can be created and approval applied for.
Ahh yes, sorry. I think you are correct. Thanks for keeping me straight.
I do wonder what their criteria is for approving a PMTA application.
Seems like with the 2007 date they are not very fond of newer stuff...
As I have said before these regs allow the FDA to drop the hammer on any or all products after 90 days. They can tie up anything they like whether or not you can prove it was in the market before the deadline. You have to meet their standards of proof (whatever those are and they can make up what they want) and they can make you wait forever and a day in the process. There are NO checks and balances.
Read it and weep
PMTA Guidance pdf
Edit: Of course this is just what they expect to be in a PMTA. No telling what their actual criteria are for an approval, I suspect they don't even have any. A simple NO solves that problem.
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A PMTA is required for products not marketed in the US by the predicate date (February 15, 2007). Manufatured by that date, isn't enough.
Oh hell, thats bad.... Really, really bad. If you havent filed for substancial equivalence by March 2011 you cannot even offer it for sale. Am I reading that right?
From page 129:
"FDA believes that this rule [I've lost track of which one] will not stifle innovation but could, instead, encourage it. The greater regulatory certainty created by the premarket review process may encourage companies to invest in creating potentially beneficial novel products, with greater confidence that improved products will not be competing against equally novel, but more dangerous, products.
"For example, a company may be more willing to invest the additional resources needed to ensure that its product is designed and manufactured with appropriate methods and controls. The PMTA pathway will incentivize development of tobacco products that pose less risk to human health by limiting market access by riskier competitor products."
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