30 days was mentioned here, but upon reading it again, it sounds like that is highly unlikely.
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Freaked me out though.
Deeming Regulations have been released!!!!
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Freaked me out though.
And that would be 10 months to filing, followed by up to 12 months to continue sale pending approval provided an application is on file.
Wouldn't they have to pay the astronomical fee with the application? If so, I don't see many applications getting filed.
I have no idea what the application fee is. But in general it is an incredibly minor part of the expense of preparing and filing one.
The major cost for filing a PMTA is paying for all the studies that the FDA wants. Kai said that 369 vapor product PMTAs have already been rejected for not including them.
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I'm truly surprised that 369 applications were even filed given that more detailed guidance for an application was only published a few days ago. What studies were required that they were rejected for? And why would 369 applications be made when no one even knew what to include?
I think everyone needs to take a step back and wait for concrete, reliable information to become available. This lawsuit needs to he resolved, clarifications on the guidelines just published will be asked and answered, and a timeline for the process will be known. Conjecture creates fear and panic. We all knew this was coming, and we all assumed everything would be eliminated from the marketplace. That extent of devastation appears less likely, but being prepared is still appropriate and can be accomplished in the remaining months of not years so from a vaper's perspective nothing has really changed. It appears the market won't be eliminated, and we need to see just what it will look like over the next few years.
All I know is what Kai's blog said.
"To give you an idea of the kind of chaos that could ensue if the deadline required is too short, according to the FDA, as of April 30, 2019 a total of 401 applications had been submitted out of which 373 were for deemed products (vape products the FDA has "deemed" fall under the FDA's regulatory umbrella that previously only covered traditional tobacco products). Of those, 369 or 99% of the applications "were closed as insufficient to accept or file, largely for failure to include an environmental assessment." Only 4 products remained, however, none of them were for e-cigarettes as they covered "heat not burn" products like Phillip Morris's IQOS."
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The rules appear to be clear that if a product application is rejected the product has to be taken off the market immediately. Maybe being closed for insufficient supporting documentation doesn't count as a rejection.
I can see why producers might keep it quiet while an application was in play, and maybe afterwards if they had other applications in the pipeline.
I can see why producers might keep it quiet while an application was in play, and maybe afterwards if they had other applications in the pipeline.
Thank you on that clarification. Far different matter than vape gear. And another example of how facts can be taken out of context.
If those are the same guys with the whole 99% of rules of the FDA are "unconstitutional" I guess we know how to interpret their information on the status of regulation.
That makes sense. I have a fuzzy recollection that Bill Godshall stated on several occasions that none have ever been filed for any vapor product.
Yeah... What would be the Harm in slapping together some Rinky-Dink SE Application and sending it to the FDA.
Who knows? Maybe you could get a New Product into the Market for a mere 20 or 30 Thousand Dollar Roll of the Dice.
I could not agree more.
I don't think folks are panicking, just discussing like we have always done. I don't see anything wrong with the discussion. We aren't running into the streets screaming or anything. If we waited for cold, hard facts, this will all be over by then since not much in the way of info and concrete guidelines are being disseminated.
Having worked for the government for many years, I have a pretty good idea of how this will play out. Doesn't impact me as I am set for life with vape stuff. I have seen what happens to 'applications' for other things on a state level. As in saying "we sent you an email outlining things we needed and didn't hear from you in x # of days so we have canceled your application/registration. Didn't do any good to say the email was never received and they don't have to show any proof that it was sent. Big businesses were approved, no problem. Bottom line is they can do whatever they want and they know it. They are not concerned about lawsuits because AAG's are available and even if they ever lose money in a lawsuit, not their money, taxpayers foot the bill so they aren't concerned about it.
I am not being a doomsayer and always hope for the best. This will be an interesting ride to see how it plays out.
Having worked for the government for many years, I have a pretty good idea of how this will play out. Doesn't impact me as I am set for life with vape stuff. I have seen what happens to 'applications' for other things on a state level. As in saying "we sent you an email outlining things we needed and didn't hear from you in x # of days so we have canceled your application/registration. Didn't do any good to say the email was never received and they don't have to show any proof that it was sent. Big businesses were approved, no problem. Bottom line is they can do whatever they want and they know it. They are not concerned about lawsuits because AAG's are available and even if they ever lose money in a lawsuit, not their money, taxpayers foot the bill so they aren't concerned about it.
I am not being a doomsayer and always hope for the best. This will be an interesting ride to see how it plays out.
I guess I had a gullible moment. It's not the first time.
I've been following Pacific Legal Foundation's blog for a while. Technically, I think they're right about 98% of the FDA's rules being unconstitutional. The problem is that nobody will do anything about it, so it doesn't matter.
Investigation Finds Thousands of Regulations Issued By Career Bureaucrats In Violation of the Constitution
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I read that PFL blog. I was struck by the summary at the end.
"Perhaps more importantly, President Trump should act. He should remind these elite bureaucrats that the American people put him in charge and that the American people have the final sign-off on the rules that govern their lives. Going forward, the president should require that only Senate-confirmed officials sign-off on his administration’s rules.
With a pen-stroke, President Trump could take power from deep-state bureaucrats and give it back to the American people."
Not to be picky, but if 98% of regulations are unconstitutional, it's not up to the executive branch to create any new rules to correct that. The judicial branch would have made that finding long ago as they're the ones responsible for determining if an action, regulation, or law is unconstitutional. And they're already ruled in cases like Chevron that agencies are empowered to create such rules and regulations under the authority granted them by Congress. It's sorta settled law.
Claiming only politically-connected Senate confirmed officials can sign a regulation makes no sense, as the publication of any regulation already falls under their ultimate responsibility as it already is. When regulations are challenged in court, among the named officials isn't the guy in room 3042 down the hall who typed it, but the Commissioner of the agency who's being called to account before the court. So yes, the Senate approved official is ultimately responsible. But to expect that every regulation and rule needs specific comprehensive review and signature by the Commissioner or whoever heads every agency would mean nothing ever gets done (as attractive as tat may sound, it's really not such a great thing) and not alter their current liability in court which already exists.
"Perhaps more importantly, President Trump should act. He should remind these elite bureaucrats that the American people put him in charge and that the American people have the final sign-off on the rules that govern their lives. Going forward, the president should require that only Senate-confirmed officials sign-off on his administration’s rules.
With a pen-stroke, President Trump could take power from deep-state bureaucrats and give it back to the American people."
Not to be picky, but if 98% of regulations are unconstitutional, it's not up to the executive branch to create any new rules to correct that. The judicial branch would have made that finding long ago as they're the ones responsible for determining if an action, regulation, or law is unconstitutional. And they're already ruled in cases like Chevron that agencies are empowered to create such rules and regulations under the authority granted them by Congress. It's sorta settled law.
Claiming only politically-connected Senate confirmed officials can sign a regulation makes no sense, as the publication of any regulation already falls under their ultimate responsibility as it already is. When regulations are challenged in court, among the named officials isn't the guy in room 3042 down the hall who typed it, but the Commissioner of the agency who's being called to account before the court. So yes, the Senate approved official is ultimately responsible. But to expect that every regulation and rule needs specific comprehensive review and signature by the Commissioner or whoever heads every agency would mean nothing ever gets done (as attractive as tat may sound, it's really not such a great thing) and not alter their current liability in court which already exists.
Abolish all the unconstitutional federal agencies (and that's most of them) and the problem would be gone.
Yes, because history shows us time & time again that corporations are more concerned with the public good than with profits...
I know we're going a bit far afield, but what agencies exist that you believe are unconstitutional and why do you believe that? Just because you don't like the policies of any given agency doesn't make them unconstitutional.
Every federal agency was voted into existence under law by congress, is funded by congress, and all that is signed by the president. Besides, they are under the executive branch which means they all, in one way or another, answer to the chief executive. There are very few that are run independently but still require Senate confirmation for the officers like the Federal Reserve, and that was done with great reason.
If you eliminate every agency as "unconstitutional" just who is supposed to execute any law that's passed? Which means there is no rule of law as there's no one to enforce it. If anyone ever worries about judicial rule from the bench now, what would happen if you eliminated every federal agency?
Not agreeing or liking a policy is one thing, but suggesting that they're unconstitutional is unhelpful in attempting to influence a policy you disagree with. Like it if not, the IRS is legal, the FDA is legal, as are all the rest.
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