Deeming Regulations have been released!!!!
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Of course it is obvious. Do you always yell when you in disagreement?
[Comment]: One comment objected that our cost estimates for the various premarket review pathways come from “unknown ‘experts’ in FDA’s Center for tobacco Products” and that “no data, studies, reports or other reference materials are cited to justify these figures, nor are any substantiated equations or methodological notes provided.”
[Response]: FDA continues to believe that FDA’s experience with premarket submissions for currently regulated tobacco products provides the closest approximation to premarket submissions for newly deemed tobacco products. Furthermore, reviewers in the Center for Tobacco Products are among the most qualified individuals to estimate these costs. FDA welcomed comments on the topic of the cost of premarket submissions and responds elsewhere to specific points made in those comments.
"Reviewers in the Center for Tobacco Products are among the most qualified individuals to estimate these costs." Oh! Skippy got a promotion! I guess that counting logos thing paid off!
I'm very blunt. In text form it can give the wrong impression. I'll admit that.
But I don't appreciate the accusation. And I expect this is the last of that.
Now let's get back on topic.
K? Thx...
Tapatyped
The HOW...............was the appointment of Mitch Zeller to CTP
Well established Anti-Tobacco, ANTI Nicotine Zealot tied to FDA DRUG Regulation.
Obviously the Pharma Sector was never able to Secure Nicotine under their Control and it became the Tool to Battle BT..............and now Vaping.
If you cannot control it - Demonize it.
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Just seems that if e-Cigarettes are now "Deemed" to be a Tobacco Product, OK, so lets make All Comparisons to Tobacco Products. In specific: Cigarettes.
Because it is OK to Sell Cigarettes in this country. So shouldn't e-Cigarettes be Benchmarked to Cigarettes?
FDA 's thinking is shortsighted as well with their blatant sycophancy to BT and BP.
Unless USA becomes a failed state like Somalia et al or isn't converted into some gulag along the lines of North Korea, you'll be looking at something like MSA II in the future:
(Fast forward a decade or two)
Vaping's been nearly wiped out on the behest of FDA's 'overseers'.
Vapers switched back to smoking and died prematurely.
Now I wonder what's gonna happen in a place where a sip of spilt coffee is worth a few mill...
Zeller and Co. won't be around by then, but their successors are likely to curse their bones every day when faced with a lawsuit and subpoenas to cough up these 'backroom protocols'
And - thanks to vaping and not giving in - their will be enough hardcore vapers left from today to give testimony.
Unless USA becomes a failed state like Somalia et al or isn't converted into some gulag along the lines of North Korea, you'll be looking at something like MSA II in the future:
(Fast forward a decade or two)
Vaping's been nearly wiped out on the behest of FDA's 'overseers'.
Vapers switched back to smoking and died prematurely.
Now I wonder what's gonna happen in a place where a sip of spilt coffee is worth a few mill...
Zeller and Co. won't be around by then, but their successors are likely to curse their bones every day when faced with a lawsuit and subpoenas to cough up these 'backroom protocols'
And - thanks to vaping and not giving in - their will be enough hardcore vapers left from today to give testimony.
Well not surprising but I was just listening to a Vaping Militia radio show and my Senator Bill Nelson- FL is against the vape industry. I need to find out when he is up for reelection and who is running against him. i just hope someone is. He has been around for so long and people just love him. He will be a tough one to dethrone.
"In addition to conducting our own research to support regulatory science, CTP partners with other agencies such as National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC), as well as with FDA’s National Center for Toxicological Research."
Informing Tobacco Regulation through Research
Don't hold your vape...I emailed Marco Rubio three times
and the first email was ignored..the next two got canned form replies
indicating that his staff had no clue what I was referring to,
apparently they thought
I was talking about the cost of prescription meds.
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Please tell me you don't really believe that spin.
Guess you could call me a "researcher"..after all Google is my friend too
I'll admit I haven't looked into it closely, but I believe they are concurrent. You need the PMTA to sell your product, and the MRTP would theoretically allow you to tell the truth about how much less deadly it is.
Also, I believe the phrase is "assume the position."
The HOW...............was the appointment of Mitch Zeller to CTP
...
So Who is the one who holds Mr. Zeller's strings?
Then. And Now.
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