Deeming Regulations have been released!!!!

[zoiDman]

It wasn't just the combustable market that got regulated, it was all tobacco products, including smokeless tobacco.

From a judicial prospective it doesn't matter if the law was not specifically written with vaping in mind. If you interpret the law as written it has very broad reach and the FDA has clear authority to deem vaping.

Everything got Swept into the TCA. That is one of the Reasons than some did Not Vote for the FSTCA.

The authority of the FDA to Deem e-Cigarettes wasn't being Questioned. It was the Judicial Deference that the FDA's Regulation of e-Cigarettes were "Reasonable" that some may question.

Is it Reasonable to set a Predicate Date before e-Cigarettes were marketed in the USA?
Is the PMTA Process Reasonable?
Is the Cost of a PMTA Reasonable?
Are the Standards that are Needed to be Achieved (the FDA Hasn't Stated Any) a successful PMTA Reasonable?
Were the Scientific Studies used to Evaluate e-Cigarettes/e-Liquids Reasonable?
Is "Intended Use" (based on... well... Nothing in Writing) Reasonable?
.
.
.
etc.

The Key Word here is "Reasonable". And that is what the Chevron Doctrine relies on.

 

[CMD-Ky]

"Ex post facto" laws are impermissible unless children, tax revenue or congressional contributions are involved.

Whereas I do not dispute that under the relevant rules, laws, and regs the FDA had the right to regulate vaping, I still feel that there was a considerable overreach. They have given themselves an incredible amount of lattitude by using theword intent, but never defining it in this context. Are tampons tobacco products? Yes...

The other issue is the predicate date. No agency should have to power to arbitrarily set an entire industry back a decade because they, as an agency, were slow catching on.

Further, enforcement will be a nightmare...

Sent from my SAMSUNG-SM-N910A using Tapatalk

 

[MacTechVpr]

None dare call it Reason.

Good luck all.

 

[Stubby]

Everything got Swept into the TCA. That is one of the Reasons than some did Not Vote for the FSTCA.

The authority of the FDA to Deem e-Cigarettes wasn't being Questioned. It was the Judicial Deference that the FDA's Regulation of e-Cigarettes were "Reasonable" that some may question.

Is it Reasonable to set a Predicate Date before e-Cigarettes were marketed in the USA?
Is the PMTA Process Reasonable?
Is the Cost of a PMTA Reasonable?
Are the Standards that are Needed to be Achieved (the FDA Hasn't Stated Any) a successful PMTA Reasonable?
Were the Scientific Studies used to Evaluate e-Cigarettes/e-Liquids Reasonable?
Is "Intended Use" (based on... well... Nothing in Writing) Reasonable?
.
.
.
etc.

The Key Word here is "Reasonable". And that is what the Chevron Doctrine relies on.

Well..... reasonable all depends on what the goal is. If the goal is the end game of a tobacco/nicotine free world (pretty much where the FDA is at with there anti-THR agenda) then anything that makes it more difficult for new tobacco products to come on the market is entirely reasonable. Everything the FDA has done has been anti-THR. To those of us who support THR (and believe that the end game of a tobacco/nicotine free world is a utopian fantasy) it is not at all reasonable.

The TCA was not written to be reasonable, in fact goes out of its way to not be, but that is the law as it stands.

 

[Lessifer]

Everything got Swept into the TCA. That is one of the Reasons than some did Not Vote for the FSTCA.

The authority of the FDA to Deem e-Cigarettes wasn't being Questioned. It was the Judicial Deference that the FDA's Regulation of e-Cigarettes were "Reasonable" that some may question.

Is it Reasonable to set a Predicate Date before e-Cigarettes were marketed in the USA?
Is the PMTA Process Reasonable?
Is the Cost of a PMTA Reasonable?
Are the Standards that are Needed to be Achieved (the FDA Hasn't Stated Any) a successful PMTA Reasonable?
Were the Scientific Studies used to Evaluate e-Cigarettes/e-Liquids Reasonable?
Is "Intended Use" (based on... well... Nothing in Writing) Reasonable?
.
.
.
etc.

The Key Word here is "Reasonable". And that is what the Chevron Doctrine relies on.

It is "reasonable" since the purpose of the TCA was to prevent new tobacco products from coming to market without FDA review and approval. If the approval process weren't so onerous and lopsided, I bet many wouldn't have an issue with it, I still would.

 

[Eskie]

Well..... reasonable all depends on what the goal is. If the goal is the end game of a tobacco/nicotine free world (pretty much where the FDA is at with there anti-THR agenda) then anything that makes it more difficult for new tobacco products to come on the market is entirely reasonable. Everything the FDA has done has been anti-THR. To those of us who support THR (and believe that the end game of a tobacco/nicotine free world is a utopian fantasy) it is not at all reasonable.

The TCA was not written to be reasonable, in fact goes out of its way to not be, but that is the law as it stands.

Certainly one of the goals in ENDS regulation is to eliminate any harm reduction claims in the absence of an NDA as that is a drug claim. And if that's what they want, I don't see any particular issue with it, and most manufacturers of vape stuff could live with it. I happen to agree with the whole first amendment as not applicable in a case like this, and we discussed this several hundred and thousands of posts earlier (no, I'm not searching for it, it's 7 am on a Sunday, and beyond my skill set at the moment).

As to the THR crowd, which are certainly stridently vocal, there needs to be some resolution as to what harm they are screeching about. Right now, I have a bunch of nicotine. Several years from now all my mods are auto firing, my tank glass is all broken, and I ran out of organic cotton. There is nothing that will prevent me from mixing up a dash of nicotine in my coffee or soda and sipping on it through the day. I can absorb nic orally, just a low concentration to avoid any side effects. Sure, not as nice as vaping, but I really need my nic and that's a way to get it.

Now, trying to follow the illogical and unreasonable nature of the current interpretation of the TCA, if I mixed up a drink and stood on the corner with my lemonade nicotine energy stand, is that a tobacco product? There's no combustion, no heating, no harm reduction claim, and no appearance of smoking associated with it. Granted, in a paper bag it might be mistaken for Thunderbird, but not much I can do about that. If that is classified as a tobacco product then the TCA has nothing to do with tobacco, just nicotine. And that's a tough sell for me, as I don't recall anything in the TCA talking about nicotine (if there is, well, there goes that argument).

The problem as I see it is we ever should have called these things e-cigarettes in the first place. That phrase sets up triggers for folks to automatically lop them in with cigarettes and tobacco.

 

[mcclintock]

^^-- It's not just the e-cig name, it's the history, however while much of the early history refers to cigarettes, not all of it refers to nicotine. In particular, while Gilbert's 1965 patent is for a "Smokeless non-tobacco cigarette" and mentions medication, it does not mention nicotine at all. It states "The size and shape of the device according to this invention may approximate the size and shape of a cigarette; therefore its use will not call undue attention to the user." Haha, times have changed. Of course, the incorporation of nicotine has been important in gaining popularity.

Still, nicotine is not an inherent part of a vaping device, it is an additive or refinement. And even if it was considered essential by the eventual inventors of modern ecigs, it is well known that inventors often do not fully predict the impact and final direction of their inventions. Did Hon Lik realize that devices and liquids would become a form of art, or vaping would include a social movement? Or possibly the final straw for politics as usual?

 

[MacTechVpr]

We fail miserably fighting regulation when its genesis and authority is legislation without principle or lawful authority.

Witness the history and progression of 2nd Amendment erosion in this country.

Extract vaping from tobacco legislation. Or forever be mired in the fight to cure government's addiction to tobacco taxes.

Good luck.

 

[MacTechVpr]

^^-- It's not just the e-cig name, it's the history, however while much of the early history refers to cigarettes, not all of it refers to nicotine. In particular, while Gilbert's 1965 patent is for a "Smokeless non-tobacco cigarette" and mentions medication, it does not mention nicotine at all. It states "The size and shape of the device according to this invention may approximate the size and shape of a cigarette; therefore its use will not call undue attention to the user." Haha, times have changed. Of course, the incorporation of nicotine has been important in gaining popularity.

Still, nicotine is not an inherent part of a vaping device, it is an additive or refinement. And even if it was considered essential by the eventual inventors of modern ecigs, it is well known that inventors often do not fully predict the impact and final direction of their inventions. Did Hon Lik realize that devices and liquids would become a form of art, or vaping would include a social movement? Or possibly the final straw for politics as usual?

I'm sure the FDA would love to "regulate" nic like a drug along with every other organic molecule we consume. Makes life simple and their purposes assured.

Good luck.

 

[stols001]

Well, the FDA isn't regulating supplements, they won't touch them with a 10-foot-pole. I guess it's a large market, but if you have that many products with almost nothing known about them other than theorizing, really, the FDA should be looking at that problem, not e-cigs, but do they want to? Nope. That would be a lot of work for little payout on their part. The supplement issue has always bugged me in a way. I mean, I use well known brands but have no way of knowing (exactly) what's in them. Far more under the FDA's purview than e-cigarettes.... Anna

 

[Eskie]

Well, the FDA isn't regulating supplements, they won't touch them with a 10-foot-pole. I guess it's a large market, but if you have that many products with almost nothing known about them other than theorizing, really, the FDA should be looking at that problem, not e-cigs, but do they want to? Nope. That would be a lot of work for little payout on their part. The supplement issue has always bugged me in a way. I mean, I use well known brands but have no way of knowing (exactly) what's in them. Far more under the FDA's purview than e-cigarettes.... Anna

Senator Orrin Hatch got that done for his state. He got legislation through to protect supplements, which happen to be big business for his state of Utah. It has stood the test of time, although misbranding and varying compositions of contents has come under scrutiny more in the last several years. But you can thank Sen. Hatch for that snow job.

 

[stols001]

Thank you Orin Hatch, the work you do is so appreciated. Thank you also, for being on the women's contraceptive/wellness committee, I'm sure you'll do a bang up job with that, since it will eventaully evolve into a court case in the Supreme court about no abortions, ever. If that day ever comes, I MAY be willing to wear a Ms. Piggy hat, that's just how we're devolving at this point. Sigh. We need to get the vape shops that are closing into Hatch's district so he can save us from the FDA, apparently. It's not a bad idea, though at times loathsome, Hatch can Get Stuff Done when needed Oy.

Anna

 

[dobroeutro]

The United States District Court for the District of Columbia has ruled with the FDA...

Nicopure Labs, Right To Be Smoke-Free Coalition, et al court decision

 

[Verb]

Certainly one of the goals in ENDS regulation is to eliminate any harm reduction claims in the absence of an NDA as that is a drug claim. And if that's what they want, I don't see any particular issue with it, and most manufacturers of vape stuff could live with it. I happen to agree with the whole first amendment as not applicable in a case like this, and we discussed this several hundred and thousands of posts earlier (no, I'm not searching for it, it's 7 am on a Sunday, and beyond my skill set at the moment).

As to the THR crowd, which are certainly stridently vocal, there needs to be some resolution as to what harm they are screeching about. Right now, I have a bunch of nicotine. Several years from now all my mods are auto firing, my tank glass is all broken, and I ran out of organic cotton. There is nothing that will prevent me from mixing up a dash of nicotine in my coffee or soda and sipping on it through the day. I can absorb nic orally, just a low concentration to avoid any side effects. Sure, not as nice as vaping, but I really need my nic and that's a way to get it.

Now, trying to follow the illogical and unreasonable nature of the current interpretation of the TCA, if I mixed up a drink and stood on the corner with my lemonade nicotine energy stand, is that a tobacco product? There's no combustion, no heating, no harm reduction claim, and no appearance of smoking associated with it. Granted, in a paper bag it might be mistaken for Thunderbird, but not much I can do about that. If that is classified as a tobacco product then the TCA has nothing to do with tobacco, just nicotine. And that's a tough sell for me, as I don't recall anything in the TCA talking about nicotine (if there is, well, there goes that argument).

The problem as I see it is we ever should have called these things e-cigarettes in the first place. That phrase sets up triggers for folks to automatically lop them in with cigarettes and tobacco.

The TCA states that it covers anything made or derived from tobacco.

The deeming did included your nicotine lemonade in the "novel" tobacco products section. It was mainly concerned with lolly-pops and lozengers, but drinks containing nicotine were on the radar. The novel products sections covered products not yet on the market or even thought of yet.

 

[HBcorpse]

The TCA states that it covers anything made or derived from tobacco.

The deeming did included your nicotine lemonade in the "novel" tobacco products section. It was mainly concerned with lolly-pops and lozengers, but drinks containing nicotine were on the radar. The novel products sections covered products not yet on the market or even thought of yet.

Fuel to the fire:

Does the TCA cover synthetic nicotine?

Also, is synthetic nicotine derived from tobacco?

What about nicotine derived from tomatoes?

 

[Fozzy71]

Countdown Until FDA Kills Vaping

 

[Rickb119]

Countdown Until FDA Kills Vaping

Time to re-check and re-calculate my supply, of EVERYTHING vape related!

 

[stols001]

Heh, I got it figured out, the juice.... there's no way I could run out of nic salts in the near future, if anything I overdid it... That being said, I also have a bunch of coils and cotton and waiting on my last surplus/goodies. I won't be making coils this weekend, I don't think. I still feel run over and like a wet rag and I overdid it yesterday, but I am on the mend. Sure hope husband and I can come to terms re: my vacopolypse closet. It's getting clear I'll have supplies until purgatory if that's where I end up. Which is okay, I'd have to vape, I have feeling purgatory is *really boring* I kind of view it as the worst Church camp imagineable. That's just me, though.

Anna

 

[zoiDman]

Well..... reasonable all depends on what the goal is. If the goal is the end game of a tobacco/nicotine free world (pretty much where the FDA is at with there anti-THR agenda) then anything that makes it more difficult for new tobacco products to come on the market is entirely reasonable. Everything the FDA has done has been anti-THR. To those of us who support THR (and believe that the end game of a tobacco/nicotine free world is a utopian fantasy) it is not at all reasonable.

The TCA was not written to be reasonable, in fact goes out of its way to not be, but that is the law as it stands.

I think a Very Important Question should be asked. And that is Who's Goal?

Because the Goal of Congress is the one that Matters. Not the Goal of a FDA (or the OPOTUS) if there Goal runs counter to the Intent of Congress.

---

What the FSTCA did to Cigarettes many saw as moving in the Right Direction. Because the argument is made that Limiting the Cigarette Market is Reasonable.

But when the FSTCA was used by the FDA to include the Same Limitations on Less Harmful "Tobacco Products" or to Stifle all New THR Products, the Goal/Intent of the FSTCA was being Subverted.

And this was what the Nicopure et al Lawsuit was arguing. Not that the FDA didn't have Authority to e-Liquids that contain Nicotine derived from Tobacco. But that the Regulations to e-Cigarettes/e-Liquids that the FDA Imposed were Not Reasonable or even Intended under the FSTCA.

 

[zoiDman]

It is "reasonable" since the purpose of the TCA was to prevent new tobacco products from coming to market without FDA review and approval. If the approval process weren't so onerous and lopsided, I bet many wouldn't have an issue with it, I still would.

Congress saw a Need to grant Authority to the FDA over "Tobacco Products" after the Supreme Court ruled against the FDA in FDA v. Brown & Williamson Tobacco Corp.

That is Reasonable. But what the FDA did with this Granted Authority is where the Problem lies.

For a Judge to Defer to the FDA Completely on e-cigarettes and All Manors of "Intended Use" is Spurious. Because the Deeming of e-Cigarettes runs counter to what the Congressional Goal of the FSTCA was. And runs counter to what the Claimed mission of the FDA is. To Protect/Improve Public Health.