Deeming Regulations have been released!!!!
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That quote is actually in the final rule, and it means what it says, they are not a "Covered Tobacco Product" but they go on later to clarify that they would be considered a Tobacco Product Component and still subject to the rule.IF your reading that in the RedLine changes document it means zilch as in nada. It can be confusing. All that matters at this point is what is said in the Final Deeming published in the federal register on 5/10/16. Which of course is quite different that your quote.
I could never be a miner. Dirty, nasty job. But, I know safety precautions today versus your grandfather's day have changed quite a bit as they have across all industry.Continuous mining machines have done a pretty good job of that on their own, without her help. Personally, I wouldn't vape coal, based on what it did to both of my grandfathers.
Kent, take a look at the header that that section is under, the deadline is on the left:
It means that by August 8, 2018 you need to submit an application for anything that was on the market as of August 8, 2016. Anything that was not on the market as of August 8, 2016 would have needed an application to enter the market.
If you are saying that I Can't sell my Pre Aug 8th 2016 product Until I submit a PMTA, then I believe you are Looking at things Wrong.
Unless something changes, which it could, I can continue to Sell my Pre Aug 8th 2016 products up to Aug 7th 2018 without filling a PMTA. And then on August 8th, 2018 Submit my PMTA for consideration.
Which leaves a dilemma for the manufacturers.
If they submit an application and it's rejected I think I read they have to remove their products from the market immediately. With no opportunity to sell off whatever they have in stock. And right now it looks like rejection is almost guaranteed. And there is no indication of how long a rejection would take to come through.
If they choose not to file they have different decisions to make. At some point they have to decide it's time to sell off their stock and close the doors. Stop making new stuff, sell what they can, have a final clearance sale, whatever. And they have to look over their shoulders at their competitors. Don't want to leave it too late when the market might have been saturated by other clearance sales.
Even harder for resellers than manufacturers. They might have a room full of stuff that can't be sold any more because the manufacturer has an application rejected, through a process they had no control over. Would they want to buy stock from a manufacturer who had submitted an application?
Hard to see a graceful shut down of the vaping industry, if that's what has to happen. If it was me I think I might be looking to get out before the rush.
Yes, filing will buy you an additional year, til Aug 2019, for a total of three. How i read your response to Sky, was that filing for a PMTA gives you two years, the implication being that not filing means you must exit the market ( prior to Aug 2018 ). And then there was the sentence about the how far the FDA will look into vendors, to see if they have started their PMTA application. That had me totally confused.
This is what you wrote :
"It appears that the FDA enforcement teams are going to start on Aug. 9th 2016. Exactly how far they will go into seeing if vendors have either started or sent in PMTA's for their inventory is not certain. But the ones that have sent PMTA's can stay open for 2 years IF the FDA hasn't rejected their applications."
Yeah, i agree with you, although i don't think the number will be 95 %. My reading of Kents post had me confused tough. It seemed to me that he is implying only by filing PMTA, do you get the two years.
That's how I understand it. This is why everyone's talking about a 2 year window before things get real hairy.
Ok, you're right. Didn't read the left column.... I'm not going to edit.... lol.... I was basically urging sky to stock up now :- )
See Bill G's post here:
White House OMB scrapped FDA plan to ban flavors
"Even worse, the deeming rule bans the manufacturing of any new tobacco product after August 8, 2016. It appears that FDA is planning to begin banning vape shops from mixing (i.e. manufacturing) e-liquids containing nicotine and/or flavorings. "
and the pdf posted May 27 at fda:
Regulations.gov
I hope so. One of them ended up in a wheelchair and missing an eye. The other one was luckier, except for being hit by a coal truck which fractured several vertebrae (he drove himself to the hospital)
Both retired sometime in the late 1960/ early 1970s.
I figure that continuous mining machines and the modernization of the whole process helped safety a lot, but there's also a lot fewer miners to worry about when they can go in with those things - safety stats have to look a lot better if you just look at shear numbers. Made up example: 100 were injured daily in such and such date, only 1 daily now. Well, duh, there's only 10 working the mine versus 1000s then.
Once Again. There is NO Guarantee of this Extra Year. If your PMTA is Denied, your are SOL at the time of the Denial.
I'm not saying that the FDA could not Extend the Time for review of you PMTA. Or to Request Additional Information from you. Or that there Isn't going to be some amount of Time that the FDA will need to Round File, I mean Review, your PMTA.
But that 1 Extra Year thing is Kinda a Red Herring is many ways.
Yeah no guarantee according to my reading of the regs, but the VTA seemed to suggest there is a guarantee. Perhaps they think the FDA won't get to it in that year, and they'll just wait for the extra year to expire. And that is why any vendor who plans to file a PMTA will likely wait right until the deadline. No point at all to file a PMTA earlier than the deadline, even if you think you have a good one ( unlikey imo, unless you are filing for a closed system ).
The Percentage is Debatable. And you are probably Right. 95% is probably Too High.
Because a Certain Percentage of current Retailers are Not going to be willing or able to comply with all State/Fed Requirements to meet the Aug 8th 2016 Deadline.
So maybe 10 ~15% are Gone as of Aug 8th, 2016? Maybe More? Maybe Less.
Hard to say.
Yeah, I find it difficult to believe all these little vendors who are completely oblivious to the FDA regs, will be able to comply with all the other elements of the regs besides PMTA.
Very True.
As all this Evolves both with the FDA's Guidance and with Legal Challenges, it would seem to be a Very Poor Choice to be Locked into an Early PMTA.
It's not like you are going to want to New PMTA's if the Landscape changes.
Seems like it is by Design almost. Doesn't it?
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So the FDA brings Harm Reduction thru e-Cigarette to it's Knees. All the while Cigarette keep on Killing People.
Good Job FDA! Way to Promote Public Health.
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