Deeming Regulations have been released!!!!

[Endor]

I have not read the entire document but after reading and skimming 200+ pages or so it seems the FDA indeed has deaf ears when it comes to our cause. Every point CASAA made has been violently rebutted or totally ignored. New rules were added. It does not feel like the document was written in the spirit of okay, maybe we can compromise on a few things.

It is worse than a DA overcharging a case to settle and plea out for lesser charges. It reads like extreme overkill. One poster said we have been bombed back to the stone age. I tend to agree. Keeping the faith is one thing. Reality is another. I am not giving up. None of should but this is a really bad day for vaping. Black Thursday.

This has been my take as well. The spirit of this deeming is certainly draconian, and does not appear to be any level of compromise. In fact, in certain cases (like the fact that zero nicotine is in scope) it is actually worse than we originally supposed.

Short of a lawsuit, which I'm struggling to see the grounds for (the FDA is operating well within the law, and under the "suggestion" of Judge Leon in the Sottera case that these are tobacco products and not medical devices), the main hope we have at this point is the Cole amendment or HR 2058 to move the grandfather date forward.

There are people a lot smarter than me in the law, and I'm sure CASAA has a small team of lawyers going over this with a fine-tooth comb. I hope I'm wrong. But, you are right, this deeming document is damn nasty.

Somebody in a previous post mentioned the NRA and gun lobby. Advocates, like Dimitri, have been pushing vendors to pay for a formal lobbyist for the past several years. Crickets.

 

[Marina2]

<snip> All Congress did was give the FDA authority over tobacco.</snip>

And that's all they should have authority over, tobacco. Instead, they've taken it upon themselves to deem nicotine base, vg, pg, flavors, empty bottles, batteries, components of all kinds, anything that is "reasonably intended" (lol, as if they're reasonably minded) to be used for vaping as "tobacco products" which fall under their authority. They've run amuck with the power that Congress granted them and they need to be stopped. What's next? The nail clippers I trim my coils with? These regulations allow them to be regulated as tobacco products if intended for vaping. I can see it now... Oh, that set of nail clippers was found along with wire and cotton... BUSTED for vaping paraphernalia!!

They know what they're doing, smoke and mirrors... Save the children. Today, we have taken a huge step to protect our children by implementing age restrictions, blah, blah blah. And, they get huge applause from the public for their efforts. All the while, they're underhandedly wiping out an entire industry that threatens the special interests that line their pockets. (yes, FDA, We the People are actually reading the entire 499 page script and calling you out!)

This is a most horrendous example of government abuse of power, one that threatens the lives of millions for generations. We need a court ruling to clarify the intent of Congress when tobacco regulation was handed over to the FDA. Surely it wasn't that they be allowed to regulate batteries to the BENEFIT of big tobacco. It had to do with that brown, leafy material, didn't it? I should be able to buy cotton and wire at the same time without fear of government seizure. Go back and do your work regulating CIGARETTES like you're supposed to be doing, FDA!

Oh, and don't even get me started on the fact that the 500 hours the FDA originally estimated to complete a PMTA was changed twice and now sits at 1700 hours. What happened? Did someone clue them in that many manufacturers can handle the expense of 500 hours? Likely. 1700 hours for each and every device, liquid, flavor, strength, ratio, tested in every device on the market, each component, every type of wicking, every type of wire... 1700 hours apiece! Realistically, that would take an eternity even if the money was available. They don't intend to approve anything. Oh wait, per the FDA, the ones most successful at getting approved are the all-in-one, tamper-proof devices, i.e. Vuse, Blue etc. It goes on and on and on. In other words, "Dont. Even. Try.... sucks to be you and not BT, BP today!"

TL;DR:
I'm so mad I could spit nails. Disgusting entity, the FDA.

 

[WharfRat1976]

Food for thought from the Rule:

One self-selected comparison reported that across several Japanese brands, under some use
conditions, ENDS released 1/50thof the level of formaldehyde released by cigarettes (Ref.
135).The highest level detected was six times lower than the level in cigarette smoke (id.).
But other research, published as a letter to the editor of the New England Journal of Medicine, reported that ENDS operated at 5 volts delivered a mean of 390+/-90 μg per 10 puff sample which is greater than 150 μg, the estimated average delivery of formaldehyde than conventional cigarettes(Ref.128). No formaldehyde-releasing agents were detected when ENDS were operated at 3.3volts (Ref.128).

 

[Mowgli]

year 2018 - overheard a vaper asking at a headshop "can I vape nicotine in that thing?"

 

[JohnnyDill]

I am a self sufficient vaper that makes his own vaporizers, makes his own juice, and has a lifetime supply of nicotine. So none of this FDA regulation will hit me. But it is simply AWFUL for all of the local vape shops. There is no way they will be able to continue doing business. Big Tobacco is to blame for all of this. I am at a loss of words........

 

[7sixtwo]

Write Dr. Ben Carson to vent your frustrations. If Trump wins Dr. Carson will probably be appointed to Health and Human Services where the FDA reports. Dr. Carson is a reasonable man and would see the benefits to vaping and likely would dilute the regulations. If Hillary wins, forget it. She'll etch the regs in stone because she knows what is best for you.

You can write whomever you want, but letters to Ben Carson are very unlikely to achieve anything.

Trump will not win, and even if he did, he's no conservative. Hillary and Trump are two sides of the same authoritarian coin.

 

[Sloth Tonight]

You can write whomever you want, but letters to Ben Carson are very unlikely to achieve anything.

Trump will not win, and even if he did, he's no conservative. Hillary and Trump are two sides of the same authoritarian coin.

Consider this post liked 100 times over.

 

[dansus]

Feel sorry for you guys, you just got royally f*cked. At least you have 2 years to battle it, heres hoping sense will prevail.

 

[Sloth Tonight]

Can I ask the community for an important clarification, my head is so heavy as all of ours are...

Does anyone know if these regs will basically criminalize possession of devices that do not meet the grandfather clause or what have you? Or is it all about future purchases etc?

 

[Andyhrn]

This is Dekang juice from Fasttech. They've been putting "FDA" on labels for a few years already.
$4.76 Dekang E-liquid for Electronic Cigarettes (50ml) - Marl-bo-ro flavor / high nicotine at FastTech - Worldwide Free Shipping

Another question is would I commit crime by buying the juice in bulk (one big bottle) from FDA approved vendor(s) and transfer it to a few smaller unmarked bottles ?

 

[WharfRat1976]

Can I ask the community for an important clarification, my head is so heavy as all of ours are...

Does anyone know if these regs will basically criminalize possession of devices that do not meet the grandfather clause or what have you? Or is it all about future purchases etc?

The Rule enables the FDA for rights of "seizure and inunction." It will be a Federal crime if the laws are not adhered to.

I am not sure as to current possession of ENDS and liquids now. That's a great question. Maybe they will make us turn in all of our gear[emoji12] at vape gear drop off centers. When prohibition took place, any alcohol you already owned was not grandfathered[emoji15]

In layman's terms they can come to your home or place of business or your automobile or your person and take all your stuff and freeze your assets and your life.

The IRS and Homeland Security have those rights as well.

I am sure they will refine their remedies but rest assured they will be enabled to use the full force of Federal law to crush your very soul.

 

[mostlyclassics]

(WharfRat1976 and I must have been pounding our keyboards at the same time.)

A bunch of folks here have tried to invoke the Constitution with regard to various features of the deeming regulation and enforcement of same.

Laws, per se, are laws, and they have to meet Constitutional muster, like not being ex post facto, guaranteeing rights of the accused, etc.

Regulations, on the other hand, have no such strictures. For example, the government doesn't have to prove that you were going to use flavors, PG, VG, etc., in making eliquid. All the FDA gnome has to do is suspect it, and you're SOL.

It's like with the IRS: in their eyes, you're guilty until you prove you're innocent.

Sorry, folks. There's no way to get around some of the more odious features of the deeming regulation.

 

[Endor]

year 2018 - overheard a vaper asking at a headshop "can I vape nicotine in that thing?"

Year 2018, overheard in a state prison:

Prisoner A: "Psst, what are you in for?"

Prisoner B: "Child molestation and murder. You?"

Prisoner A: "Constructive possession of a rebuildable atomizer."

 

[WharfRat1976]

Year 2018, overheard in a state prison:

Prisoner A: "Psst, what are you in for?"

Prisoner B: "Child molestation and murder. You?"

Prisoner A: "Constructive possession of a rebuildable atomizer."

BAWAHAHAHAHAHAHAHAH...that's funny.

 

[WharfRat1976]

(WharfRat1976 and I must have been pounding our keyboards at the same time.)

A bunch of folks here have tried to invoke the Constitution with regard to various features of the deeming regulation and enforcement of same.

Laws, per se, are laws, and they have to meet Constitutional muster, like not being ex post facto, guaranteeing rights of the accused, etc.

Regulations, on the other hand, have no such strictures. For example, the government doesn't have to prove that you were going to use flavors, PG, VG, etc., in making eliquid. All the FDA gnome has to do is suspect it, and you're SOL.

It's like with the IRS: in their eyes, you're guilty until you prove you're innocent.

Sorry, folks. There's no way to get around some of the more odious features of the deeming regulation.

Great post and thanks for the differentiation. Whenever constitutional rights screamers start spouting I go deaf anyway. Their arguments are always such a non sequitor.

 

[Bob Chill]

I don't believe there will be any seizures or requirements to turn in your non grandfathered legally bought gear. It would be pretty dumb and nobody would comply. I'm sure the premise would be that things would just slowly fade with time. Just like old cars with no emission controls.

The scarier part is not allowing open systems. Then there is nothing to put in a tank so the hardware becomes irrelevant by default.

 

[Katmar]

I'm sorry, but I have to agree with @WharfRat1976. This is OVER.

It's obvious that the FDA has determined to kill vaping in the USA. They have been very thorough in effectively eliminating any and all avenues where vaping is concerned.

For months, I've heard people cry "I'll just DIY!" Well, the FDA was listening. Not only have they covered nicotine, but they targeted flavors and the vials they come in. No, I don't think "but this is for food use" will work. They have also covered all supplies that can even be remotely associated with vaping, down to batteries, cotton, and wire. "But this is for my flashlight" isn't going to cut it either. Do you think the manufacturers of cheap flashlights will pave the way? No, they will integrate batteries into their devices that allows them to be plugged in to charge because they don't want to get involved in the .... storm that is going to surround the vaping community.

And yes, I'm sorry, negativity DOES have a place here. For years we have all dutifully signed all the petitions, called and emailed our representatives and done whatever has been asked of us to thwart this regulation from coming to pass. Did any of this have even the slightest effect on the FDA regulations? No.

Not one thing was changed in the FDA policies. Not one. In fact, it could be argued that it got even worse than originally imagined. Is it realistic to believe that even 100,000 signatures will make a damn bit of difference against the slick lobbying machine that Big Tobacco has running right now? That machine has been vastly effective in attaching a stigma to vapers, perpetuated by our own fools within this community who insist on blowing massive clouds, labeling their juices in the most cartoonish ways imaginable, and stupidly building crappy mods that catch fire. Every story like that is pumped up by the media so now the majority of the world believes that vaping is not safe at all.

Believe me, that's the next step - strengthen that stigma until we as vapors are as ostracized as the cigarette smoking public. Remember, to the average person we ARE smoking. We are sucking on a device and smoke is coming out of our lungs. It doesn't matter how much we cry "it's only vapor!" or "it's not harmful!" - we are smoking in their eyes.

Make no mistake - we are dead meat in the very near future. Sheer optimism and high hopes will do nothing to save us. We don't have the bankroll, and we don't have a snowball's chance in Hell with congress. Can you find more than 5 or 6 congressmen who support vaping and focus on the health benefits? Do you honestly believe a good percentage of hopeful candidates will stand up and voice their support for us when the majority of the voting public has been swayed by the anti-hype or is plain apathetic?

I apologize for this War & Peace length post, I just needed to rant. I'm sickened as well, and I will stock up on my own DIY supplies and devices and hunker down in my bunker. But that's all any of us will be able to do.

The FDA has changed it's mind in the past. We don't know that they won't this time. We are all sickened by this, but now is the time to fight even HARDER. Reaching out to ALL in the vaping community. Hit up ALL the vaping forums you know of. Your friends, family. Get as many people involved as you can. It is NOT over. Read what CASAA had to say today. Other Vaping organizations are saying the same thing. They are certainly NOT ready to give up. NOT even CLOSE. If you want to feel this way, that's on you. I want you to stay and fight with us, even if you ARE discouraged. Thank you for reading this....

 

[7sixtwo]

A bunch of folks here have tried to invoke the Constitution with regard to various features of the deeming regulation and enforcement of same.

Laws, per se, are laws, and they have to meet Constitutional muster, like not being ex post facto, guaranteeing rights of the accused, etc.

Regulations, on the other hand, have no such strictures. For example, the government doesn't have to prove that you were going to use flavors, PG, VG, etc., in making eliquid. All the FDA gnome has to do is suspect it, and you're SOL.

It's like with the IRS: in their eyes, you're guilty until you prove you're innocent.

Sorry, folks. There's no way to get around some of the more odious features of the deeming regulation.

Which leaves you in the position of having to prove a negative. Good luck with that.

Make no mistake folks, the only reason the FDA delayed the release of this horse manure from 2014 until today was to gather information on the specific details of all materials even tangentially related to e-cigs; so they could make their tyranny as comprehensive and inclusive as possible. Their goal is not to protect anyone's health.. their goal is to crush vaping. To hell with facts, to hell with actual science. They are the kings of the ANTZ and this was always their intention.

 

[7sixtwo]

The FDA has changed it's mind in the past. We don't know that they won't this time. We are all sickened by this, but now is the time to fight even HARDER. Reaching out to ALL in the vaping community. Hit up ALL the vaping forums you know of. Your friends, family. Get as many people involved as you can. It is NOT over. Read what CASAA had to say today. Other Vaping organizations are saying the same thing. They are certainly NOT ready to give up. NOT even CLOSE. If you want to feel this way, that's on you. I want you to stay and fight with us, even if you ARE discouraged. Thank you for reading this....

Polite advocacy has accomplished precisely jack squat. We needed organized activism, (like the NRA, etc), and we needed to start years ago.

To be fair, we didn't have much time. The FDA, (no doubt prodded by Big Pharma and Big Tobacco), moved pretty quickly to destroy vaping in its infancy.

 

[skoony]

This is Dekang juice from Fasttech. They've been putting "FDA" on labels for a few years already.
$4.76 Dekang E-liquid for Electronic Cigarettes (50ml) - Marl-bo-ro flavor / high nicotine at FastTech - Worldwide Free Shipping

Another question is would I commit crime by buying the juice in bulk (one big bottle) from FDA approved vendor(s) and transfer it to a few smaller unmarked bottles ?

correct me if i am wrong but,this is already a no,no. One can't even say
it's made in a FDA approved lab. Even if your lab is up too ISO standards.
Seeing the FDA hasn't certified anyone yet to make e-juice is a bit if a problem
also i believe.
Mike