No, they will become the products that establish what new products will have to be substantially equivalent to.Will they still have to go through the SE process?
No, they will become the products that establish what new products will have to be substantially equivalent to.Will they still have to go through the SE process?
No, they will become the products that establish what new products will have to be substantially equivalent to.
That's what I thought, but after the Final Rule is in place, there has to be a way for the FDA to know which products are grandfathered and which ones are new. For example, there has be a way for the FDA to document that Avail Vaper makes Strawberry juice, but Pioneer Vapes does not. With all the vapor products on the market right now, it's going to be a paperwork nightmare for somebody.
Done:
Dear Rep. Long,
I write today to ask you to support H.R.2058 - FDA Deeming Authority Clarification Act of 2015 dealing with the "grandfather date" that is hard coded into the FSPTCA. This date, February 15, 2007, is the date the FSPTCA was enacted into law by Congress. The date is important since it is the date which beyond no new tobacco product could be marketed without going through extremely expensive (on the order of a million dollars per very specific product) new product approval or substantial equivalence. (This does not guarantee a product approval, it is the research and fees to submit for approval)
H.R. 2058 would make the "grandfather" date for any newly deemed tobacco products (deeming puts a product under FDA authority to regulate) the date the deeming becomes final, just as the hard coded date did with cigarettes. The FDA is in the process of deeming ecigarettes as a tobacco product. As it stands this hard coded date would make all ecigaretee products not on the market before the date subject to the expensive approval.
Congresses intent was to leave products on the market before the date of deeming available, however the hard coded date has (unforeseen at the time) dire impact on the ecigarette market. If the hard coded date is kept, then greater than 99% of all existing e-cigarette products will be effectively banned and the whole industry will be turned over to big tobacco since they are the only ones that can afford to put their products through the process.
Further exacerbating the issue is that big tobacco "cigalikes" are less effective at keeping people off cigarettes than the products that will be effectively banned. I myself smoked cigarettes for over 20 years and although I tried gums, lozenges, cold turkey, hypnosis, and Chantix (which I wouldn't wish on my worst enemy) I was unable to stop. I had resigned myself to smoking for whatever lifespan I had left. One day I tried a big tobacco "cigalike" but over the course of several weeks was back to smoking. I ran across someone using what is referred to as a "mod" which is a second generation ecigarette that has no resemblance to a cigarette and he conveyed to me that he had tried cigalikes with similar results but the mod had worked for him. I ordered one (there were no brick and mortar shops in Springfield at the time) and have not touched a cigarette in over over 2 years and have no urge to. I feel better, can breath better, taste food, and no longer smell like an ashtray. Am I less likely to die from the effects of ecigarettes than from combustible cigarettes? Research is pointing that direction, but that is not what this bill is concerned with. It is concerned with my personal liberty to choose to use second and third generation ecigarettes (which will be effectively banned) instead of smoking combustible cigarettes.
Please consider supporting H.R. 2058 and even co-sponsoring it. Do not let big tobacco win and take over the industry with their inferior cigalikes.
This is a fantastic bill but I fear it has no chance of passing. If it does pass house and senate does the president need to sign it? I don't think he would if that is the case. Either way I filled out the CASAA form and it has been sent.
That's what I thought, but after the Final Rule is in place, there has to be a way for the FDA to know which products are grandfathered and which ones are new. For example, there has be a way for the FDA to document that Avail Vaper makes Strawberry juice, but Pioneer Vapes does not. With all the vapor products on the market right now, it's going to be a paperwork nightmare for somebody.
Think "enforcement discretion"
Sounds like the politically correct translation for "protection racket".
And "selective enforcement", an age old tool.Sounds like the politically correct translation for "protection racket".
WOW! Thanks. Grover Norquist and the Gang! I could be fuzzy on this but isn't the ATR a pledge/document that Rs have to sign and support otherwise Grover insures they are toast as in Grover finds an opponent, throws a ton of money behind them, and insures that his candidate gets elected? If I have my ducks in a row ?? /lol this could turn out to be a huge huge huge battle with perhaps the Rs tying up the final rule which must hit Congress for years and years. Not to mention all the noise and delays the Rs can create in the Confirmation hearings for the next Commisioner of the FDA aka Desk Killers. I could certainly be wrong and I might be overstating Commander Grover's power?
Any political wonks want to set me straight or help explain this?
WOW! Thanks. Grover Norquist and the Gang! I could be fuzzy on this but isn't the ATR a pledge/document that Rs have to sign and support otherwise Grover insures they are toast as in Grover finds an opponent, throws a ton of money behind them, and insures that his candidate gets elected? If I have my ducks in a row ?? /lol this could turn out to be a huge huge huge battle with perhaps the Rs tying up the final rule which must hit Congress for years and years. Not to mention all the noise and delays the Rs can create in the Confirmation hearings for the next Commisioner of the FDA aka Desk Killers. I could certainly be wrong and I might be overstating Commander Grover's power?
Any political wonks want to set me straight or help explain this?
It used to be that no Republican would dare not sign and adhere to the Pledge. He had a real grip on the party, because the backlash from defying him would be huge. In recent years, some Republicans have been more willing to break from the rigidity.About the Taxpayer Protection Pledge | Americans for Tax Reform
It's a pledge to a candidate's constituency:
ONE, oppose any and all efforts to increase the marginal income tax rates for individuals and/or businesses; and
TWO, oppose any net reduction or elimination of deductions and credits, unless matched dollar for dollar by further reducing tax rates.
Grover can't really 'insure' they are toast if they go back on the pledge. However, he may help organize any campaign against the candidate/office holder. This really is no different than the DNC, RNC, Emily's list (fem Pac), Club for Growth Pac, Sierra Club, NRA, NEA, etc. etc. etc. They will put up primary fights against those who don't follow their pledges, goals, purposes, ideologies.
The reason guys like Grover or Stephen Moore (CFG), Wayne LaPierre, etc. make the news as sometimes ogres, is they're mainly Republicans. You won't either know or hear about the head of Sierra, NEA or Emily's list since the media likes all those guys So they're heroes/heroines but the others are villains. Got it now? lol
It used to be that no Republican would dare not sign and adhere to the Pledge. He had a real grip on the party, because the backlash from defying him would be huge. In recent years, some Republicans have been more willing to break from the rigidity.