Deeming Regulations have been released!!!!
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That's not the one I was thinking of. It might have been Rolygate. Seem to remember it wasn't in a regular thread but some pinned thread maybe. I know I've looked for it several times without success.
Bill Godshall, perhaps? Doesn't really ring a bell. Sorry.
Speaking of Bill Godshall, haven't seen him post or heard anything about him. Where has he been?
I think Mr. G pushed himself too hard sometimes but in between those times he wrote some brilliant stuff. I miss his link lists.
Crossing my fingers... (Sorry if this has been posted, I haven't seen it here)
https://www.khlaw.com/Files/44066_FDA petition re COVID PMTA Extension final.pdf
Regulations.gov Beta
https://www.khlaw.com/Files/44066_FDA petition re COVID PMTA Extension final.pdf
Regulations.gov Beta
Oops. caught a typo. The document says they want to request and extension to March 8, 2020. Should be 2021
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I saw that too, he addressed it on twitter and corrected the typo before submitting it.Oops. caught a type. The document says they want to request and extension to March 8, 2020. Should be 2021
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Good old Azim! Godspeed, Azim!
A strong letter to follow.
And maybe another lawsuit!!!!
All around the mulberry bush
The monkey chased the weasel...
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World 
Please leave a comment. @kristin --do we need a new CTA?
Azim Chowdhury
@ECIGattorney
·
13h
Our Citizen Petition has been docketed under FDA-2020-P-1797. Go to http://regulations.gov and leave a comment:
https://beta.regulations.gov/document/FDA-2020-P-1797-0001…
Quote Tweet
Received today from Mig Vapor:
TO OUR CUSTOMERS IN THE UNITED STATES
We Are Here To Stay
Many of you have been calling and asking after the September 9th FDA deadline, will we still be here in business?
The short answer is yes. We have been working for 3 years slowly paying as we could, to advance into the FDA submission requirements.
I am happy to inform you all, our submission will be sent before September 1st 2020
Yes it is costing more than we can afford, however we have been doing all we can. We will absolutely survive to help and continue to support all the Miggies out there.
-Team Mig Vapor
We will do what ever it takes, so as to survive and support you our customers. We are not Big tobacco. We are America, and American small business, and by God I will fight to the last breath to help and continue to serve you.
- Wallace Moorman CEO
It's the 1st they've released anything about it. Let's hope other small players have been doing the same -- quietly doing what they need to do to survive... At least until the FDA rejects their products.
TO OUR CUSTOMERS IN THE UNITED STATES
We Are Here To Stay
Many of you have been calling and asking after the September 9th FDA deadline, will we still be here in business?
The short answer is yes. We have been working for 3 years slowly paying as we could, to advance into the FDA submission requirements.
I am happy to inform you all, our submission will be sent before September 1st 2020
Yes it is costing more than we can afford, however we have been doing all we can. We will absolutely survive to help and continue to support all the Miggies out there.
-Team Mig Vapor
We will do what ever it takes, so as to survive and support you our customers. We are not Big tobacco. We are America, and American small business, and by God I will fight to the last breath to help and continue to serve you.
- Wallace Moorman CEO
It's the 1st they've released anything about it. Let's hope other small players have been doing the same -- quietly doing what they need to do to survive... At least until the FDA rejects their products.
From Mitch Zeller:
Although we do not know how many applications will be submitted by the September deadline, we do know that there are over 400 million deemed products listed with FDA. Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced.
......
Consistent with the court order that set the Sept. 9, 2020 application deadline, for products with timely applications, FDA may continue to defer enforcement of the premarket requirements for up to one year through Sept. 9, 2021 (unless a negative action is issued by the FDA on an application during that time). Examples of negative actions include Refusal to Accept (RTA), Refusal to File (RTF), and a No Marketing Order (NMO).
......
Although CTP has greatly expanded its reviewing capacity and is developing well-defined, consistent and transparent review processes for all phases of premarket review, there are limits to these resources considering we may receive applications for several millions of products.
.....
Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.
.....
we plan to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline, were on the market as of Aug. 8, 2016, and for which a premarket application is submitted by Sept. 9, 2020. However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed.
....
Although we do not know how many applications will be submitted by the September deadline, we do know that there are over 400 million deemed products listed with FDA. Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced.
......
Consistent with the court order that set the Sept. 9, 2020 application deadline, for products with timely applications, FDA may continue to defer enforcement of the premarket requirements for up to one year through Sept. 9, 2021 (unless a negative action is issued by the FDA on an application during that time). Examples of negative actions include Refusal to Accept (RTA), Refusal to File (RTF), and a No Marketing Order (NMO).
......
Although CTP has greatly expanded its reviewing capacity and is developing well-defined, consistent and transparent review processes for all phases of premarket review, there are limits to these resources considering we may receive applications for several millions of products.
.....
Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.
.....
we plan to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline, were on the market as of Aug. 8, 2016, and for which a premarket application is submitted by Sept. 9, 2020. However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed.
....
That is one of the Best Things I have ever heard Mitch Zeller say.
BTW - Do you have a Link to the source?
Well knowing how much Big Tobacco and the Government hates vaping, I fully expect the FDA will be mailing millions of Refusal to Accept (RTA) letters on Monday, September 10. My understanding is the FDA doesn't have to state the reason for the refusal. Of course there will be lawsuits, but the Government will get the taxpayers to pay for it all anyway. And then drag it out until the e-cig community is bankrupted.
Then we enter into the new post September 10th era.
Then we enter into the new post September 10th era.
It seems the "on the market" date is still in force for PMTA applications, so those products that came on the market after 8/8/16 don't qualify for PMTA or any extensions, right? Only "substantial equivalence" to approved products at some future date would apply if I recall correctly.
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