Deeming Regulations have been released!!!!

[englishmick]

I may be wrong, but wasn't there a previous attempt to make vape a drug, and we (vapers of the time) actually fought that off, arguing that it shouldn't be a "drug"? If (a big "if") my memory serves me, that's how it came that vape got labeled as a tobacco product.

I'm not 100% on that, and I think it happened somewhere in the 2010-2012 (ish) range, but I think we (vapers as a whole) may have had a hand in the bullet that now resides in our collective foot. It's not something that's often discussed here, but for some reason I'm thinking it played out along similar lines (of my thought).

Any long-time vapers recall this, or have I just lost my mind (a distinct possibility)?

@Katdarling - recollections or hallucinations, I?

"What a terrible thing to have lost one's mind. Or not to have a mind at all..."

It really did happen. But if vaping had come under the drug regs they could have shut down vaping overnight as a drug delivery system. The tobacco designation saved us. Existing law meant they weren't allowed to shut down smoking through regulation, and we were included in that protection.

 

[DPLongo22]

That would be when Smoking Everywhere and NJoy sued the FDA and Judge Leon ruled that e-cigs are not drugs, but they might be able to regulate them as tobacco products.


.

That'd be the one, yes.

Grazie.

 

[rosesense]

I may be wrong, but wasn't there a previous attempt to make vape a drug, and we (vapers of the time) actually fought that off, arguing that it shouldn't be a "drug"? If (a big "if") my memory serves me, that's how it came that vape got labeled as a tobacco product.

I'm not 100% on that, and I think it happened somewhere in the 2010-2012 (ish) range, but I think we (vapers as a whole) may have had a hand in the bullet that now resides in our collective foot. It's not something that's often discussed here, but for some reason I'm thinking it played out along similar lines (of my thought).

Any long-time vapers recall this, or have I just lost my mind (a distinct possibility)?

@Katdarling - recollections or hallucinations, I?

"What a terrible thing to have lost one's mind. Or not to have a mind at all..."

That is about how I remember it but I don't think we had a clue what it meant if it went the other way like what we ended up with as a tobacco product.

 

[Rossum]

That would be when Smoking Everywhere and NJoy sued the FDA and Judge Leon ruled that e-cigs are not drugs, but they might be able to regulate them as tobacco products..

Exactly. Judge Leon ruled that the FDA could regulate vapor products as tobacco products, but they have never been under any statutory obligation to do so. That's what makes Judge Grimm's decision in this case seem wrong to me.

I've not been able to find a copy of the decision itself. In fact I haven't found the official name or docket number for the the case. Can you tell I'm not a lawyer?

What I have found is that Judge Grimm found that the FDA's delay is in violation of the Tobacco Control Act of 2009. Really? That act doesn't mention vapor products at all!

Government constantly finds ways to extend its powers beyond what the law actually gives it.

 

[zoiDman]

...

I've not been able to find a copy of the decision itself. In fact I haven't found the official name or docket number for the the case. Can you tell I'm not a lawyer?

https://dockets.justia.com/docket/maryland/mddce/8:2018cv00883/417298

 

[440BB]

Now we have to look to the FDA to fend this off. Ironic. Sad. Ridiculous.

 

[dreamvaper]

There was an alco black market, if they want an e-liquid one, they'll get it

 

[DPLongo22]

Government constantly finds ways to extend its powers beyond what the law actually gives it.

"...if you can keep it."

Evidently not.

 

[CMD-Ky]

@Rossum

For your convenience, here is the decision with a link to download the opinion. The pdf is far easier to read.

Am. Acad. of Pediatrics v. U.S. Food & Drug Admin, 330 F. Supp. 3d 657 | Casetext

 

[Rossum]

@Rossum
For your convenience, here is the decision with a link to download the opinion. The pdf is far easier to read.
Am. Acad. of Pediatrics v. U.S. Food & Drug Admin, 330 F. Supp. 3d 657 | Casetext

Thank you, sir. Will grab that when I'm on a real computer a bit later today.

 

[Eskie]

The argument feels like it should be overturned on appeal as there are no dates specified by Congress enacted as law to regulate e cigarettes. The arbitrary date was established based on the agency's discretion, which means it's free to alter it's rule making process based on the agency's judgement, like the (in)famous Chevron decision on discretion to the responsible regulatory agency best equipped to make and enforce rules. I'm not sure how the judge could miss that one or why the FDA didn't hammer it home, but I would expect if they are at all competent they will. They will appeal as if they leave the decision as is it will become precedent for future challenges completely unrelated to e cigs but applicable to other regulatory decisions.

 

[CMD-Ky]

Thank you, sir. Will grab that when I'm on a real computer a bit later today.

If you don't want to deaden your mind, I offer the world renowned:
CMD Synopsis: Get at it, regulatory state, do your "studies", post those scary pictures, you are letting a good crisis go to waste.

Quote from the opinion:

C. Remedy

The remaining question is the proper time frame for the agency to act. The court orders that, no later than September 26, 2018, the FDA shall provide to this court an expedited schedule for the completion of outstanding studies, the publication of the proposed graphic warnings rule for public comment, review of public comments, and issuance of a final graphic warnings rule in accordance with the Tobacco Control Act. Plaintiffs may submit a response to the proposed schedule no later than 14 days after the FDA files its expedited schedule. The court intends to direct further action, as necessary, following review of the expedited schedule.

IT IS SO ORDERED.

 

[DaveP]

The clarifications are getting muddier as the market attempts to redirect the sources of nicotine from tobacco to other synthetic sources, such as tomatoes. The article is from 2017.

FDA ‘clarifies’ stance on synthetic nicotine as a tobacco product

“Q: The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?”
“A: The definition of "tobacco product" includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities.
However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”
The second paragraph is the most important. It appears as if the FDA’s current opinion on synthetic nicotine is that it should not be regulated by the FDA. But is this reason enough for the vaping industry to jump for joy in celebration?

 

[Rossum]

The second paragraph is the most important. It appears as if the FDA’s current opinion on synthetic nicotine is that it should not be regulated by the FDA.

This strikes me as wishful thinking.

"would not be regulated by the FDA as a tobacco product" is not at all the same as "won't be regulated at all". Remember the Sottera decision? It prevented the FDA from banning vapor products as "unapproved drug delivery devices" because the nicotine in them was made from tobacco. The FDA could easily revert to that stance and simply ban any vapor product that contains "non-tobacco" nicotine.

I think it would be a big mistake to pin our hopes on non-tobacco nicotine.

 

[CMD-Ky]

There is a historical basis for your thoughts in that there is a hostility to other synthetics. It's a small jump from one horribly addicting synthetic substance to another horribly addicting synthetic substance.

This strikes me as wishful thinking.

"would not be regulated by the FDA as a tobacco product" is not at all the same as "won't be regulated at all". Remember the Sottera decision? It prevented the FDA from banning vapor products as "unapproved drug delivery devices" because the nicotine in them was made from tobacco. The FDA could easily revert to that stance and simply ban any vapor product that contains "non-tobacco" nicotine.

I think it would be a big mistake to pin our hopes on non-tobacco nicotine.

 

[MacTechVpr]

In my estimation it's always been FDA's wet dream to regulate nicotine, in all its derivations. All organics for that matter and inferentially, nutritrionals.

You are what you eat; and, they own it.

Good luck.

 

[zoiDman]

@Rossum

For your convenience, here is the decision with a link to download the opinion. The pdf is far easier to read.

Am. Acad. of Pediatrics v. U.S. Food & Drug Admin, 330 F. Supp. 3d 657 | Casetext

This was the Lawsuit involving Graphical Warnings, correct?

Court Directs FDA to Issue Final Graphic Cigarette Warning Rule by March 2020

 

[Bronze]

In my estimation it's always been FDA's wet dream to regulate nicotine, in all its derivations. All organics for that matter and inferentially, nutritrionals.

You are what you eat; and, they own it.

Good luck.

Allow me to expand. In my estimation it has always been the federal government's wet dream to control all aspects of our lives. A few renegades in the late 18th century tried putting an end to that. Hence, the second amendment. The trend lately has not been good.

 

[CMD-Ky]

This was the Lawsuit involving Graphical Warnings, correct?

Court Directs FDA to Issue Final Graphic Cigarette Warning Rule by March 2020

Yes, that is correct, the pediatricians want to enforce the requirement that the FDA produce some scary pictures to enhance the effectiveness of the textual warnings then they want some data about how effective the scare campaign was.

 

[MacTechVpr]

Yes, that is correct, the pediatricians want to enforce the requirement that the FDA produce some scary pictures to enhance the effectiveness of the textual warnings then they want some data about how effective the scare campaign was.

Yes, for the children's sake…and we're "It".

Good luck.