Deeming Regulations have been released!!!!

Vandal

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I had pneumonia every year the last years I was smoking, each case worse than the last, and I'd had issues with bronchitis for decades. I seemed to be a bit more resistant to colds than some, but I still got them. Since I started vaping, not so much as a sniffle. I live with my sister (have for a few years), who is an ex-smoker (she quit long ago), who frequently gets colds. I have yet to catch one from her. I had thought I quit having respiratory illnesses due to quitting smoking, but now I can't even seem to catch a cold. So, it does have me wondering.
 

DC2

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Am I the only one around here who thinks it's wrong for government to restrict someone from stating an objectively true and provable fact about a product -- that this is indeed an abridgment of free speech?
Yes, you are the only one.
You seem to be some kind of dangerous rebel in my opinion.

I'm going to be keeping a close eye on you!
:laugh:
 

Slots

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Another thread was posted just this morning about no more colds since vaping came into their lives
Makes sense, since PG is a germicide

Making claims like that would be considered a "medical claim" and you would have to have reams of data to prove it in order to advertise it. FDA doesn't care about that as they know it would be virtually impossible to validate it.
That might not be so hard to "validate", since it's used in asthma inhalers with the FDA's blessing.

With regard to PG, if you were born in a hospital, the first breaths you drew on this earth were well laced with PG --
It's been in use in hospital ventilating systems for many decades because it's a germicide.
Because of the PG scum problem, it's mostly been replaced with micropore filters.
Also, many surgeons and OR nurses have spent 12 hours per day, five or six days per week in operating theaters for their whole careers, and operating theaters used to get really heavy doses of PG via the ventilation systems.
So did office buildings, and retirement homes to help prevent the spread of germs.
The FDA has called it "generally recognized as safe."
 

bigdancehawk

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Makes sense, since PG is a germicide


That might not be so hard to "validate", since it's used in asthma inhalers with the FDA's blessing.

With regard to PG, if you were born in a hospital, the first breaths you drew on this earth were well laced with PG --
It's been in use in hospital ventilating systems for many decades because it's a germicide.
Because of the PG scum problem, it's mostly been replaced with micropore filters.
Also, many surgeons and OR nurses have spent 12 hours per day, five or six days per week in operating theaters for their whole careers, and operating theaters used to get really heavy doses of PG via the ventilation systems.
So did office buildings, and retirement homes to help prevent the spread of germs.
The FDA has called it "generally recognized as safe."
The asthma inhaler claim is dubious. There is some evidence that PG is or was used in nebulizers and for lung transplant patients. And it was tested and used in hospitals as an aerosol anti-microbial agent. Bottom line is that it would be difficult to find anything safer to inhale than PG other than water vapor. And unlike water, PG does have a proven anti-microbial effect.
 

mattiem

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Maybe if the hospitals had continued using pg in the ventilation systems they wouldn't be having the rampant staph infections they are seeing today. I have heard horror stories about folks that survived the surgery just fine but the staph infection almost did 'em in. My nearest neighbor is almost over his latest one.
 

Eskie

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Look at it this way. If there is some sort of pandemic, we vapers may be the only ones left! THAT would be interesting!

In which case, our vapocalypse supplies will be even more valuable. Who would want to survive a pandemic without a vape?
 

Bob Chill

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Just saw this:

FDA E-Cig Regulations Harm Innovation, Public Health; Groups File in Support of Challenge to Deeming Rule

"Washington, D.C. - Today, TechFreedom and the National Center for Public Policy Research filed an amicus brief in support of the challenge to the FDA's new regulation of e-cigs being brought by Nicopure Labs, a manufacturer of e-cigarette liquid.

In May, the FDA finalized its Deeming Rule regulations, which would force e-cig manufacturers to undergo an expensive and time-consuming premarket tobacco application process unless their products were on the market -- or substantially equivalent to a product on the market -- prior to the predicate date of February 15, 2007, long before modern e-cigs were introduced. The high cost of the application process means most e-cig businesses will be forced to shut down, eliminating choices of dramatically safer alternatives to combustible cigarettes, which will leave smokers with fewer options to compete against the most harmful form of nicotine consumption, combustible tobacco.

The brief concludes:

The FDA's Deeming Rule fails to consider the scientific evidence readily available to the agency regarding the safety and the public health benefits of e-cigarettes. The Deeming Rule is improper under the APA not merely because it fails any manner of scientific analysis, and is therefore arbitrary and capricious, but also because it is in direct conflict with Congress's intent to prevent smoking and aid cessation through the [Family Smoking Prevention and Tobacco Control] Act.
"
 

Mazinny

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"Instead of developing science-based standards which would reduce harm, the FDA directly admitted it didn't understand or evaluate the potential benefits or harms of e-cigarettes," said Jeff Stier, Senior Fellow at the National Center for Public Policy Research. "Without that science, it relied on the 'precautionary principle' standard, in direct conflict with the evidence-based standard required by Congress."

That last sentence could have a substantial influence in proceedings, if true. By true i mean if Congress specifically required an evidence based standard for the regs and rules.
 

Eskie

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The FDA's Deeming Rule fails to consider the scientific evidence readily available to the agency regarding the safety and the public health benefits of e-cigarettes. The Deeming Rule is improper under the APA not merely because it fails any manner of scientific analysis, and is therefore arbitrary and capricious, but also because it is in direct conflict with Congress's intent to prevent smoking and aid cessation through the [Family Smoking Prevention and Tobacco Control] Act."

Yet they still were able to spin out 500 pages of regulation without any evidence based support for them.
 

mattiem

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I really hope cooler heads and lawsuits will prevail and this steaming pile of poo called deeming regulations is put through a shredder and is never allowed to rear its ugly, insane head again. Well, one can hope and if one is going to wish it may as well be a good one. :)
 

Bob Chill

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I really hope cooler heads and lawsuits will prevail and this steaming pile of poo called deeming regulations is put through a shredder and is never allowed to rear its ugly, insane head again. Well, one can hope and if one is going to wish it may as well be a good one. :)

Now that we are seeing specific details of the opposition to the regs, it makes you wonder how the FDA will successfully defend their stance. At least in its entirety anyways. Seems like they are banking 100% that they can simply jam ecigs into the guidelines set forth in the FSPTCA and call it a day. If things start to unravel for the FDA in court is could end up being another embarrassment. I'm not particularly optimistic but it's going to be a very interesting court battle to say the least.
 

Eskie

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I really hope cooler heads and lawsuits will prevail and this steaming pile of poo called deeming regulations is put through a shredder and is never allowed to rear its ugly, insane head again. Well, one can hope and if one is going to wish it may as well be a good one. :)

Cooler heads and lawsuits rarely go together. If they did, legal bills would be much lower.

At the end of all this, there will be regulation of vaping. But hopefully regulation based on evidence and real world experience, with reasonable expectations that manufacturers and vendors are offering products that have been properly prepared like juice, and safety tested for hardware. Products should do what they claim. Basic electrical safety should not be asking too much of manufacturers. Chances are the majority of larger manufacturers and vendors of juice already meet adequate standards. And small businesses should be able to demonstrate basic safety in preparation and be judged on a similar level to small vendors of cigars or pipe tobacco.
 

Lessifer

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I read all 499 pages, but probably only comprehended 10% of it.
I think part of the problem is, there are no objective standards throughout the entire document, or any of the guidance to the industry.

It's like the mixing in store, or building coils in store, there is actually a section that says that if you did that before 8/8 you can still do it, but you will be considered a manufacturer and would have to comply with manufacturing standards. I have yet to find what those standards are. Then of course there leaves the question, well, if I build the same coil is it the same product? That appears to depend on the level of enforcement.
 

Bob Chill

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I think part of the problem is, there are no objective standards throughout the entire document, or any of the guidance to the industry.

Yea, no kidding. It's not just part of the problem. It's pretty much the biggest problem. The total lack of specific rules/standards/procedures on a host of very important pieces of the package in conjunction with a short time frame of implementation is quite irresponsible and stupid. It's a multi-billion dollar industry that affects millions of people. And nobody know what the heck is going to happen and those who made the rules can't even answer questions. It's pretty much a disaster imho.
 

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