I'm not a Lawyer. But if the Plaintiffs motion for Summary Judgment is Fully Granted, didn't we Win?
FDA FDA response to lawsuits.
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I'm not a Lawyer. But if the Plaintiffs motion for Summary Judgment is Fully Granted, didn't we Win?
I can't get past the first 20 pages. Such utter garbage. My experience with e-cigarettes has been the complete opposite from FDA bizzaro world view. How did our country come to this lowly state of operation?! 
I can't get past the first 20 pages. Such utter garbage. My experience with e-cigarettes has been the complete opposite from FDA bizzaro world view. How did our country come to this lowly state of operation?!
Because there is Little Transparency and almost No Oversight when it comes to the FDA.
If you're the FDA, you can get a Lot Done when it is All Done in the Shadows. And about the Only Oversight is an Extremely Expensive Lawsuit(s) such as what we are seeing.
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You mean like the OMB/OIRA that Rubber Stamped the Deeming?
Or 5 U.S.C. § 801-808 (The Congressional Review Act) which Congress did Not Invoke?
Or a Senate Oversight Committee that the FDA can Blow Off if it wants to?
I hadn't heard this before, that they aren't going to step on spare parts and coils and so forth. They may just be blowing smoke. I don't know where the definition of "finished tobacco products" comes from. Does battery just mean an 18650, or would it include a Spinner. Or a battery holder of whatever type. You can build an entire Kayfun from spare parts. The coil part could be a sliver of good news, if they aren't lying about it for the purpose of the court case. There are enough Nautilus tanks out there already to make it worth the while of the Chinese to make and sell coils for a long time.
They say "the FDA plans to enforce....". Is this plan written down somewhere? Presumably they could change their plan whenever they choose.
Moreover, there is reason to doubt Nicopure’s hyperbolic calculations about the effects of the rule on its own business, which are based on the faulty assumption that it will submit premarket applications for every item in its internal stockroom—including batteries, heating coils, and replacement parts—even though the FDA plans to enforce the premarket application requirement only with respect to “finished tobacco products,” such as “e-cigarettes, or e-liquids sold separately to consumers,” id. at 29,019.15
They say "the FDA plans to enforce....". Is this plan written down somewhere? Presumably they could change their plan whenever they choose.
Moreover, there is reason to doubt Nicopure’s hyperbolic calculations about the effects of the rule on its own business, which are based on the faulty assumption that it will submit premarket applications for every item in its internal stockroom—including batteries, heating coils, and replacement parts—even though the FDA plans to enforce the premarket application requirement only with respect to “finished tobacco products,” such as “e-cigarettes, or e-liquids sold separately to consumers,” id. at 29,019.15
If I'm a judge, which I am not, but if I were, when the FDA states that there is no need to even look at the whole situation my first thought is: "I'm the judge here and I don't like being told what I should and shouldn't look at! In fact, I will be the judge of what I decide what is worth my time! Just because your the FDA and think you can just say things doesn't make it so." Again, if I were a judge.
http://www.tobacco-on-trial.com/wp-content/uploaded/2016/07/20-2.pdf
See line item #27
"... Even if Nicopure eliminated 80% of its products in response to the Deeming Rule, submitting PMTAs for the remaining 20% would take approximately 720,000 hours (equal to 30,000 days or 82.2 years) to complete. A dedicated team of 10 employees would take nearly a decade to complete that task if all 10 team members worked 24 hours a day, 7 days a week, 365 days a year—yet FDA has allotted only 2 years for compliance"
Taking this a step further; If Nicopure eliminated 90% of it's products (leaving only 240 SKU's of the original 2400 Nicopure currently offers) it would still take 5 years for the 'dedicated team' to complete the task with no guarantee a single one of them would pass FDA's muster.
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They don't have the legal authority to ban cigarettes. Congress grandfathered all tobacco products that were on the market as of Feb. of 2007.They did acknowledge that cigs are the most dangerous product ever brought to market, but don't mention why they are allowing them to stay on the market...
I believe it started with mandatory bicycle helmets.How did our country come to this lowly state of operation?!
But it may have started way before that.
No, regulatory agencies are designed to avoid that whole silly mess.
It may even have been a good idea once upon a time, had it not become corrupt.
But then again, that is the nature of all governments, so it was inevitable that it become corrupt.
So yeah, no, it was never a good idea.
My current understanding is that a "finished tobacco product" is one that is packaged and sold directly to the consumer. So any given product could be a "finished tobacco product" or not, depending on who it is sold to. Even if the seller and the product are the same in both cases.
Nicotine base sold directly to you?
Finished tobacco product.
PMTA rests on the shoulders of the seller of nicotine base.
Nicotine base sold to someone creating eliquid for sale?
Not a finished tobacco product.
PMTA rests on the shoulders of the eliquid seller.
There are arguments here that can and should be used against them when attempting to enforce, for instance their take on 0-nic is very interesting. Also they state intent is determined by the seller...
I think you said "defendants" a couple of times when you meant plaintiffs.YT posted the PDF here yesterday:
Lawsuits mount against FDA regs on e-cigarettes
Actually, I'm going to disagree with you here. Usually, when I read a lawsuit it is refreshingly logical, as opposed to emotional. I've sat thru many court trials and have never found the law and it's proceedings to be "illogical". I think that is the beauty of the law.
While I may not LIKE the outcome, the requirement of legal proceedings is the ability to use logic. You don't get to say things like "but water can be dangerous too!" and stuff like that. Basically, as I briefly read the pdf it just seems like they are sticking with Soterra and the job Congress gave the FDA to regulate stuff..... both of which already have been legally established. The long history of the tobacco industry of lying is not something the FDA is willing to go thru again and either is anyone else, so the burden of proving anything after BT debacle just naturally became more difficult.
Burden of proof and all that, it sounded to me that the arguments/reasonings surrounding non nicotine products used in conjunction with vaping haven't been well explained (yet) by the defendants at least not in a compelling way. There is more work to do, and yes, it does require a long string of go-arounds. That is always true when you are trying to prove an unjustified regulatory burden.
As with any lawsuit, it's not one thing, it's a number of things that get to be examined and decided on.
I doubt any defendants in the lawsuit thought it was going to be lickety-split. Now they have more to go on, more insight about how the FDA is seeing things, and how we should proceed from there.
It's a PROCESS.
I remember when big land development corporations would put their bulldozers atop all those nice sand dunes (nature's protection of the land beyond the sea) and started levelling them to build billion dollar condo projects. The local municpalities with their bare-bones legal staff would be trying to stop the bulldozers from raping the land while the development corps would bring their armies of Philadelphia lawyers........of course the municipalities ran out of resources and money and now we have no sand dunes to speak of.
Anybody bringing a lawsuit knows this ahead of time........i.e. that it will be expensive and time-consuming.
More legal battles ahead. Hopefully all the vendors are kicking in some monies to the various defendants? The same problems exist in horse racing as vaping industry..........no centralization, instead each racing venue and each state in the US has their own little commissions and sets of rules.........I can only say that NOTHING has gotten accomplished that way and I've been watching it for 20 years.
That's why I said 4 years ago that the vaping industry needed to band together under ONE large trade organization.
That never happened.
Yes, the lack of a strong, unified voice for vaping similar to the NRA has been a big problem. Effective organization and good leadership go hand in hand.
The first few pages of discussion are full of inaccurate or false statements easy to find in bad journalism. But a couple of points. If nicotine is so addictive how can the FDA allow the gum and patches to be sold over the counter? May be cause they are liars. They know nic is not so addictive. The best news about ecigs are the kids prefer them to smoking. How can that be anything but good news?
It's interesting they are so interested in pre mix. The way I read it they are insanely jealous of the outrageously good markups and they aren't getting their cut. (I predict pre mix will end up as a small niche in the market. That will happen because most life long vapers will mix and new vapers will drift away from the activity because it's not so addictive and since they never smoked they don't need relapse protection.)
The FDA arguments about the risks of vaping are awful. They have no science because they don't acknowledge there is any science even though they commission it. They let the lawyers write the science stuff instead of researchers and it shows.
They do acknowledge they apply pharmecutical standards to ecig products. At most they should be applying food standards. I wonder how hard it would be to get pre market approval for brussel sprouts? They're reaction would be that they've been around for a while and aren't hurting anybody. Well you could make that argument for vaping too.
It's interesting they are so interested in pre mix. The way I read it they are insanely jealous of the outrageously good markups and they aren't getting their cut. (I predict pre mix will end up as a small niche in the market. That will happen because most life long vapers will mix and new vapers will drift away from the activity because it's not so addictive and since they never smoked they don't need relapse protection.)
The FDA arguments about the risks of vaping are awful. They have no science because they don't acknowledge there is any science even though they commission it. They let the lawyers write the science stuff instead of researchers and it shows.
They do acknowledge they apply pharmecutical standards to ecig products. At most they should be applying food standards. I wonder how hard it would be to get pre market approval for brussel sprouts? They're reaction would be that they've been around for a while and aren't hurting anybody. Well you could make that argument for vaping too.
You mean plaintiffs. The FDA has known for quite some time that nicotine alone isn't "highly addictive." Their in-house lawyers are simply lying.
Really weird. Compared with that, even the EU-Commission (TPD2) looks so much more unprejudiced..
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