Deeming Regulations have been released!!!!

zoiDman

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I'm not sure whether they're trying to couch some nefarious (to us) intent in that language or if they're just making good-sounding noise to placate the anti-vape crowd.

Given the FDA, and the current climate of e-Cigarettes, I would say a Little from Column "A", and a Little from Column "B".
 

440BB

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It might feel pretty good!
Two+Brothers+Pillar+of+Salt.jpg
 

MikeE3

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From the Link in this thread...

Spring Unified Agenda: FDA’s Anticipated Upcoming Regulatory Work

"..., we [the FDA] will be proposing a new regulation to establish product standards for electronic nicotine delivery systems or ENDS. The proposed standard will, among other things, address the levels of toxicants and impurities found in nicotine, propylene glycol, and vegetable glycerin e-liquid, as these toxicants and impurities can cause death or other adverse health effects.

..."

Spring Unified Agenda: FDA’s Anticipated Upcoming Regulatory Work | FDA Voice

Big Wheel Keeps on Turning
Proud Mary keeps on Burning
Roll'n
Roll'n
Roll'n Down the River

But they let all those 'medicinal' drugs advertised on TV with a "bajillion" side effects including death be marketed. I suppose it's Ok because the packaging isn't kid friendly.
 

englishmick

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I heard Trump talking about drugs yesterday. One of the items on his list is a regulation change allowing people with major medical problems to use drugs that haven't been approved yet (something that should have happened a long time ago IMO). Seems like they could apply the same logic to vaping. Maybe it hasn't been proved to be 100% safe yet, but it can save people from something that has a good chance of killing them.
 

MacTechVpr

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I heard Trump talking about drugs yesterday. One of the items on his list is a regulation change allowing people with major medical problems to use drugs that haven't been approved yet (something that should have happened a long time ago IMO). Seems like they could apply the same logic to vaping. Maybe it hasn't been proved to be 100% safe yet, but it can save people from something that has a good chance of killing them.

I don't know of anything at all that can be found categorically free of harm. We live in the physical universe. And I don't see the authority of the FDA or gov to interject themselves to legislate, regulate or control contracts in the realm of impracticability, i.e. acts of God. Natural nicotine, due to its presumptive harm, the pretext of all this madness, is not a man-made patentable anything which by the thinnest thread might give these fools some jurisdiction. They keep acting under the color of law and we keep buying into to the gross perversions of process by placating them. The goal is and has always been to gain a control over nicotine by the creative reclassification of it as a drug. Now, anything associated with it. They test us to see just how far this tenuous thread of dribble can be stretched.

I can't imagine anything more dangerous to us all than gov's assumption that it can own and control natural process or its constituents. Or worse still, that it can subordinate such authority to the unelected and unaccountable. This, the very real and actual threat to our health, welfare and security. The historical premise Trump should be talking about.

Good luck. :)
 
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stols001

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I have agreed with Trump's policy on medications since he rolled it out (well, the idea of more choice, not so sure he cares as much about "cost" as he trumpets.

With that said, I'd like to see it actually be applied (I know it takes time, etc.) and yes, although it will never happen, I'd like to see him fold ecigs into that. It's not going to happen, but it would be very nice.

Anna
 

Shawn Hoefer

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Yes. Let's turn the populace into lab rats by treating them with unproven drugs they can't afford to ameliorate symptoms they've only been told they have by commercials on the television or that were side-effects of the last drug they were prescribed.

The whole thing plays right into the pockets of Big Pharma.

Where does that leave vaping?

"Ask your doctor if the Novartis TC100 with prefilled 6mg Novarotine in fresh mint is right for you. Side-effects may include empty wallets and lack of choice."

Sent from my LG-H931 using Tapatalk
 

stols001

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To be honest, my preferred outcome (he said it at one point) was that medications tested overseas with decent results would be allowed in without an (almost impossibly) lengthy and expensive review.

One of the meds that worked best for me was a drug manufactured in France, but they French were like, "merde" to you, and did not do FDA studies. It is a novel drug with an absolutely stunning and different mechanism of action compared to any antidepressants here. The only side effect of note was that if you had asthma, it might improve your condition. I imported it for several years but the cost was truly prohibitive, and I could only ever get to partial dosage strength, due to the cost, and also importing (while one of those grey areas) really became too difficult. That med also helped various siblings, and they all agreed that compared to the SSRIs, it was phenomenal.

It's now off patent, so no one is going to bother to "scoop it up" in FDA studies.

I would use a new drug rushed through the approval process if I had AIDS, or some terminal cancer. I'd have nothing to lose at that point.

I don't care, necessarily, for big pharma, and use generics every chance I get (mainly because the long term side effects are known and studied-- FDA studies are TWELVE weeks long.

With that also said, as someone who has literally been REQUIRED to deal with "big pharma" (and it certainly wasn't pleasant, but better than my alternatives) and medications, I don't see more choice as a bad thing, and many overseas meds have been tested MORE thoroughly than the FDA requires.

Just offering a real world example. Sometimes, things get tough. At that point in my life, had I not chosen to import (and pay for) a "non-available" med... .Things would have been a lot harder.

And, I will say, I have become more and MORE of a researcher, the longer I have to deal with "Big Pharma." Usually , that can help me avoid many of the major headaches.

But taking meds is JUST one big headache. I'm so happy to be on a stable regimen.

Just thought I'd provide the "other" perspective, and as usual, just my opinion as always.

NONE of it is going to impact vaping however. NONE.

Anna
 

CMD-Ky

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Winner on older generics, far better idea what you are in for and can make a much more informed choice. The final FDA clinical trial is the release of a drug to the public.

To be honest, my preferred outcome (he said it at one point) was that medications tested overseas with decent results would be allowed in without an (almost impossibly) lengthy and expensive review.

One of the meds that worked best for me was a drug manufactured in France, but they French were like, "merde" to you, and did not do FDA studies. It is a novel drug with an absolutely stunning and different mechanism of action compared to any antidepressants here. The only side effect of note was that if you had asthma, it might improve your condition. I imported it for several years but the cost was truly prohibitive, and I could only ever get to partial dosage strength, due to the cost, and also importing (while one of those grey areas) really became too difficult. That med also helped various siblings, and they all agreed that compared to the SSRIs, it was phenomenal.

It's now off patent, so no one is going to bother to "scoop it up" in FDA studies.

I would use a new drug rushed through the approval process if I had AIDS, or some terminal cancer. I'd have nothing to lose at that point.

I don't care, necessarily, for big pharma, and use generics every chance I get (mainly because the long term side effects are known and studied-- FDA studies are TWELVE weeks long.

With that also said, as someone who has literally been REQUIRED to deal with "big pharma" (and it certainly wasn't pleasant, but better than my alternatives) and medications, I don't see more choice as a bad thing, and many overseas meds have been tested MORE thoroughly than the FDA requires.

Just offering a real world example. Sometimes, things get tough. At that point in my life, had I not chosen to import (and pay for) a "non-available" med... .Things would have been a lot harder.

And, I will say, I have become more and MORE of a researcher, the longer I have to deal with "Big Pharma." Usually , that can help me avoid many of the major headaches.

But taking meds is JUST one big headache. I'm so happy to be on a stable regimen.

Just thought I'd provide the "other" perspective, and as usual, just my opinion as always.

NONE of it is going to impact vaping however. NONE.

Anna
 

englishmick

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The goal is and has always been to gain a control over nicotine by the creative reclassification of it as a drug. :)

I've been wondering about this for while. It's been talked about here but it doesn't seem to be happening, which doesn't make much sense. They have a lot to lose in terms of their patches and lozenges.

If nic really has potential for treating something of serious magnitude like Alzheimer's then the model BP is likely to want is super expensive prescription use, and vaping would get in the way of that.

So maybe the next fight a few years down the road will be BP bringing the hammer down. And they really are the big guy on the block. BP and their allies in the medical industry have enough money and politicians to squash vaping like a bug. Perhaps they are standing back now hoping that vaping gets diminished to the point where it will be easy to finish off later.
 

englishmick

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Yes. Let's turn the populace into lab rats by treating them with unproven drugs they can't afford to ameliorate symptoms they've only been told they have by commercials on the television or that were side-effects of the last drug they were prescribed.

Right. If BP weren't the most vile industry on the planet we might not need so many regulations.
 

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Myk

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But they let all those 'medicinal' drugs advertised on TV with a "bajillion" side effects including death be marketed. I suppose it's Ok because the packaging isn't kid friendly.

Exactly. Medical researcher I know says how low the odds of getting cancer are with a drug (that I'm on). Uhh, you do realize that's higher than the risk of getting cancer from smoking, right?
That was the risk of relapse that was higher but the risk of 1st cancer wasn't that much lower.
Knowing the risks is good. Not letting people make their own decisions about risks is bad.


Yes. Let's turn the populace into lab rats by treating them with unproven drugs they can't afford to ameliorate symptoms they've only been told they have by commercials on the television or that were side-effects of the last drug they were prescribed.

We already are. How many drugs get black box warnings added or completely pulled from market after they've been released to the general public?
You simply can not test for every possible situation in a RCT and RCT does not reflect the real world.
That is why ecigs being in the real world for so long without a problem holds more scientific value than any lab even if the scientists studying them were honest.


I don't care, necessarily, for big pharma, and use generics every chance I get (mainly because the long term side effects are known and studied-- FDA studies are TWELVE weeks long.

They allowed generics for biologics before the patent is up, biosimilars. They're not identical because that would be impossible so that is how it's not patent infringement. The thought was the prices would come way down. They didn't, the generic makers are just profiting a ton.
Plus the $36,000 for the infusion isn't for the drug, the drugs cost in the $6000 range across the board, the highly variable and vastly increasing rest of the money is the hospital. When I started the drug at the end of 2015 the cash price was $24,000, in 2 years it was increased to $36,000 (I haven't looked lately). Insurance still pays about the same $15,000 it always has, it's only those who pay cash without the negotiating ability that get screwed.

The fear is people get forced onto the biosimilar and the biosimilar isn't saving that much money but the generic company doesn't have an assistance plan.
Which assistance plans can't be used with Medicare/Medicaid, they're considered a kickback. Yet how many elected officials have Big Pharma donating to their campaigns and that's not a kickback.
It's one big corrupt, greedy protectionist racket.
 
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CMD-Ky

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One thing about rich businesspeople. They are misers when it comes to operating costs. It runs in their blood. It's a part of the game of success to them even tho it is chump change to them.

Overhead is the difference between a profit and a loss.
 

stols001

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Well, for those on Medicare (I currently am, it was a HUGE adjustment) do keep in mind that if you qualify, financially, you can get big pharma assistance.

One of my meds had a $487 per month copay. There is NO similar drug or generic. So, I applied directly for financial assistance, met criteria, and quite frankly their "assistance program" is less hassle, and far better, than trying to "fill" any medicine through my insurance.

The big pharma folks aren't ALL bad. It was one of the easier and more stress-free applications I've done in my life. Sometimes, folks don't realize that yes, big pharma wants to make a profit when it can, but if you truly cannot afford a non-generic medication, you have options.

Unfortunately, I know all this stuff since I was a SW, but I ALSO had to do it myself.

I had no insurance when I arrived in Tucson so got to "enjoy" public mental health through Medicaid. It was one of the worst "provisions of care" I ever got. I also WORKED in public mental health, and it's a mess.

You gotta know each and every step of the labyrinth. Etc.

Anna
 

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