I wholeheartedly agree.That's my take also. How am I supposed to obey the law when I don't know what thelaw is?
Deeming Regulations have been released!!!!
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Yeah. And in Australia and New Zealand and EU and Russia. We're quickly becoming Singapore. No offense to Singapore. Even in Saudi Arabia vaping is allowed.
I'm sure that someone posted here, something from the fda advising shops to check wth the manufacturers of products to be sure they were allowed under deeming rules.
Or, I could be wrong.
Or, I could be wrong.
There is a Concept in Law called an "Implied Obligation".
The FDA is the Only Entity who can Verify that a PMTA has or has not been Submitted for a given "Tobacco Product". And what the Current Status of it is.
So if the FDA wants Compliance with the FSPTCA and the Deeming Rule Set while PMTA's are being evaluated, they have an Obligation to Inform Stakeholders just what Can and Cannot be Legally Sold.
Well not explicitly. But they did call us all manufacturers elsewhere if we import anything tobacco whether finished product or no. So let me get it straight, FDA regulates the manufacture, distribution and sale of tobacco. So Congress separately writes in a broad discretion for the FDA to instruct enforcement action including on individuals by CBP (Regulatory Procedures Manual, Dec 2017, Chap 9 Import Operations and Actions, 9-2). Nevermind that this generally applies to goods that have been restricted from importation and CBP has specific notice and advice. Yet somehow they will know the battery in my package is in violation because it is, after all, tobacco.
How in tarnation is that supposed to work? And for the same reasons as approved or not PMTA products. Customs does not know. However, FDA can easily solve the problem by narrowing PMTA approvals quickly to their subjective definition of desirable Stage 4 devices and that will make matters rather simple enough for the idjutz.
There's really not much more to add regarding this unlawful appropriation of the vaping industry by agency. We've all been criminalized in effect and will be treated accordingly for thinking differently. The only question remaining is, to what degree.
Good luck.
Meant as a bit of a joke, but....
Like in all departments of the US Gov't, there are regulations based on underlying laws. As almost everyone (here, at least) knows, the laws re: ecigs are Tobacco Control Act of 2009 (specifically sections 903(a)(1) and 903(a)(7)(A) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 387c).
And, like many laws, they are not formulated clearly so that unelected bureaucrats can interpret them to their own biases.
Looks like the NACS (National Association of Convenience Stores) wants a list also:
FDA to Make PMTA List Public
Retail Groups Urge FDA to Release List of PMTA Filers - Vapor Voice
Retailer Groups Ask FDA to Publish PMTA List for Vapor Products
https://www.convenience.org/Media/D...CS/Industry-Letter-re-PMTA-List-(8-25-20).pdf
FDA to Make PMTA List Public
Retail Groups Urge FDA to Release List of PMTA Filers - Vapor Voice
Retailer Groups Ask FDA to Publish PMTA List for Vapor Products
https://www.convenience.org/Media/D...CS/Industry-Letter-re-PMTA-List-(8-25-20).pdf
Oh, I know. I'm just so perturbed right now I want to throw a heavy object at somebody. The smoke filling the air and blocking the sun doesn't help.
"Zeller also noted that some deemed tobacco products may be eligible for “grandfathered status” because they were commercially marketed in the United States as of Feb. 15, 2007. These products aren’t “new tobacco products” and, therefore, do not need to submit premarket applications unless they were since modified, according to the FDA. Many cigar, hookah tobacco and pipe tobacco products fall into this category, he said."
Well, that's just peachy! I'll have a cigar.
I agree but I don't expect to see a list anytime soon.
in the meantime I do expect the FDA to will send out some warning letters to "show they mean business".
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And the SCOTUS can warrant them the laxity to do so.
Good luck.
Or not... in rare cases.
Hey Katya...WHAT HAPPENED??? Yesterday (in the eGo ONE thread)...you were calm/cool/collected...when you said..."Let's see what the next chapter brings. I'm forever hopeful."
.
That's my take also. How am I supposed to obey the law when I don't know what the
The plan: ignorance of the law is not an excuse.
A list is not part of "the law". They would have to change the law every time they add or remove a product from the list, so that would never work.
So since the list is not written into the law, ignorance of the list that doesn't even exist isn't ignorance of the law.
So since the list is not written into the law, ignorance of the list that doesn't even exist isn't ignorance of the law.
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I agree but I don't expect to see a list anytime soon.
in the meantime I do expect the FDA to will send out some warning letters to "show they mean business".
It's just Hard to Say.
Because without a Publicized List, that seems like the FDA\CTP could be Opening Up a Pandora's Box for the Lawyers to jump out of. And the ensuing Maelstrom in the Media would make the CTP look like Rubes.
Zeller wants to Keep His Job if things change at the White House. So I think he will want to Avoid any Unnecessary Black Eyes if possible.
JMO...
But I think the CTP is going to Lay Low until the get a PMTA/Non-Market Order List together. Then they'll give things a week or so to make it looks like they have given Retailers ample warning. Then they'll start cranking up the Printers and start sending the Warning Letters.
But Hey, for a Agency that Fly's in the Face of Common Sense on Most Things. who knows?
One thing I have learned is there is no predicting what the FDA will do at any given moment.
Recall Seldane, the only medication that helps my cat allergy I even tried shots for years and they did not work. I was bitter. Seldane was going to enable me to become a vet although I am NOT a vet and I must say, GLAD not to be vets have more debt than medical school etc.
But some folks dropped dead due to Q-T rhythms. They could have recommended an EKG or these days a genetic test (you have the susceptibility or you don't. But like nooooo..... Even though NOTHING else works.
Then you have Clozapine-- probably one of the drugs most likely to kill you (seriously) you have to get weekly blood tests for a long time and a host of other things and expect to like gain 678 lbs also not to mention "other stuff" but it is still on the market "For schizophrenia that has responded to no other things."
Only-- Off label prescribing. No doc gets in trouble for that unless it's a controlled substance.
They just..., It's going to be like 52 card pickup. WHO KNOWS NO ONE DOES NOT EVEN THE FDA YET THEY WERE JUST LIKE EVEN WITH COVID WE CAN'T PUSH THIS OUT AGAIN OH HOW I WANT TO I HATE ECIGS AS MUCH OR MORE THAN ANY OTHER POLITICIAN.
Lay low. Seriously, take it easy for a while.
Or, go nuts until this is some how "determined."
No one in the FDA knows ANYTHING about ecigs except the dude that quit, and they don't understand clinical studies anymore either.
Anna
Recall Seldane, the only medication that helps my cat allergy I even tried shots for years and they did not work. I was bitter. Seldane was going to enable me to become a vet although I am NOT a vet and I must say, GLAD not to be vets have more debt than medical school etc.
But some folks dropped dead due to Q-T rhythms. They could have recommended an EKG or these days a genetic test (you have the susceptibility or you don't. But like nooooo..... Even though NOTHING else works.
Then you have Clozapine-- probably one of the drugs most likely to kill you (seriously) you have to get weekly blood tests for a long time and a host of other things and expect to like gain 678 lbs also not to mention "other stuff" but it is still on the market "For schizophrenia that has responded to no other things."
Only-- Off label prescribing. No doc gets in trouble for that unless it's a controlled substance.
They just..., It's going to be like 52 card pickup. WHO KNOWS NO ONE DOES NOT EVEN THE FDA YET THEY WERE JUST LIKE EVEN WITH COVID WE CAN'T PUSH THIS OUT AGAIN OH HOW I WANT TO I HATE ECIGS AS MUCH OR MORE THAN ANY OTHER POLITICIAN.
Lay low. Seriously, take it easy for a while.
Or, go nuts until this is some how "determined."
No one in the FDA knows ANYTHING about ecigs except the dude that quit, and they don't understand clinical studies anymore either.
Anna
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