Lawsuits mount against FDA regs on e-cigarettes

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Racehorse

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..........."Even if the tobacco industry had no history of false and misleading statements about the relative health risk of their products........"

......."The need for review of modified risk tobacco products is illustrated by the tobacco industry’s long history of selling and distributing purportedly “reduced risk” tobacco products that have not, in fact, reduced risk—a history that threatens to repeat itself in the context of ecigarettes, which implicate many of the same actors and already have employed many of the same strategies........."

........."Although there are certainly many smaller manufacturers and independent vape shops in the e-cigarette market, it is dominated by the major tobacco companies........"

........."Altria Group, Inc. v. Goode, 555 U.S. 70, 90 n.14 (2008). And “[w]e now know that low-tar cigarettes not only did not provide a public health benefit, but they also may have contributed to an actual increase in death and disease among smokers.”

It's hard to develop trust when things like this have taken place. Burned once.........
There can still be positive outcome, as more and more research and knowledge come to light, it is just that there are hoops and hurdles that will present in the meantime.
Sort of like life.......eventually things get straightened out but sometimes it takes quite a lot of curly Q's before you get there......I DO see smoother sailing but at the present time, and into the more immediate future, I think things will be very tough for vaping.

Sometimes I even think that while we are waiting around, something else will be developed that is even more technological than vaping. You know with the genome project(s), it may eventually be something as simple as just "flipping a switch". (they have already watched inflammation and obesity genes turn on and turn off....they can actually SEE it happening .......)
 
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Racehorse

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if you just read the first 3 pages............

there are no words :-x:cry:

Yeah they are pretty mired in the "Congress gave the FDA" this task stuff.

But the tobacco companies did so much damage, so much.....there is no way to put that genie back into the bottle and henceforth, everything will be judged on the basis of just how much they lied, about everything and anything.

There is no way anybody is going to let that happen again.......so they will have to be convinced, little by little, with research, studies, and LOTS OF PROOF.
 
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Lessifer

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Yeah they are pretty mired in the "Congress gave the FDA" this task stuff.

But the tobacco companies did so much damage, so much.....there is no way to put that genie back into the bottle and henceforth, everything will be judged on the basis of just how much they lied, about everything and anything.

There is no way anybody is going to let that happen again.......so they will have to be convinced, little by little, with research, studies, and LOTS OF PROOF.
Except that e-cigarettes ARE NOT CIGARETTES and there really is no reason to assume they carry any similar risks. I honestly don't know if the courts would make that distinction, or if this is really just a matter of the law, but I'm afraid it's the latter and I don't know if there is a strong case under the law.
 

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That would worry me. There are SO many ill-informed people. I would hate to have them on a jury regarding vaping. Think of all those articles we read that said vaping is worse than combustibles. .

That's why there is jury selection.

This is all very well vetted ahead of time.
 

Racehorse

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Except that e-cigarettes ARE NOT CIGARETTES

It doesn't matter if they are or arent' cigarettes. You're missing the point. They could be moondrops or fountain of youth inhalers........my point was that the FDA is saying they already went thru all that "this is safe!" song and dance before, and it turned out very badly for everybody.

They are not going to make that mistake again.

IF you look at the Table of Authorities, Federal Cases, you can see where they are going.....
 
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Racehorse

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One of the money shots:

"The e-cigarette manufacturers in Sottera objected to the FDA’s attempt to regulate their products as “drugs” or “devices” under the FDCA, arguing that the products must instead be regulated under the Tobacco Control Act. The D.C. Circuit agreed........."

"There is no meaningful difference between the e-cigarettes at issue here and those in Sottera....."
 

Lessifer

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It doesn't matter if they are or arent' cigarettes. You're missing the point. They could be moondrops or fountain of youth inhalers........my point was that the FDA is saying they already went thru all that "this is safe!" song and dance before, and it turned out very badly for everybody.

They are not going to make that mistake again.

IF you look at the Table of Authorities, Federal Cases, you can see where they are going.....
IF they took that same approach with EVERY consumer good they were an authority over, that would make sense, but they don't. They have reason to be wary combustible products made from tobacco. Vapor products bear no resemblance to such products, though I know there is precedence.
 
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Racehorse

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IF they took that same approach with EVERY consumer good they were an authority over, that would make sense, but they don't.

Well they did on trans fats, (partially hydrogenated vegetable oils) and all the people here who eat that kind of stuff on a pretty regular basis were very "put out." And i mean VERY put out. [Personally I consider it poison for my arteries, because it is, and wouldn't touch it with a 10 foot pole. (thank god for food labels!) ]

Now the labelling I"ve seen on some peanut butter recently is "fractionated palm oil", which is really really bad for you. This is typical word tricks by the food industry.

I don't know if people are as unhealthy as the ones I see in arkansas, but I can't believe how big everybody is here. When I first moved here I found it very......startling......never having been around so much obesity. Then I lived here for 10 years and watched the eating patterns.......

look, trans fats kills people just as sure as cigarettes kill people.

I imagine the american landscape, when it comes to health, looks rather schizophrenic from the outside looking in. :lol: What would a space alien see? On the one hand, citizens BEGGING the FDA to "allow them to be healthy" by approving an alternative to smoking....but on the other hand, and equal amount of citizens kicking and screaming when anybody even suggests advice that may just bring them their wish? (taking hydrogenated vegetable oil out of foods is actually good for everybody).

It's all very strange........

then, you have the added perplexity and complexity of figuring out who is in who's back pocket.
.
 
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bobwho77

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bigdancehawk

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Actually, there are plenty of words, but the moderators won't let me write them here.
I guess I don't see why this would be upsetting. This is an adversarial proceeding and FDA lawyers aren't going to wag their tails and roll over like Golden Retrievers.

My favorite part of the brief is their claim (in effect) that it's not arbitrary or an abuse of discretion for them them to rip an industry apart without doing a serious cost/benefit analysis.
 

seminolewind

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At least there are people out there challenging the FDA on the most important question. What does tobacco related mean and how are vapers (ecig needs a new name) a tobacco product without tobacco? Inhaling steam? Such as Vick's Vaporrub? Coffee? Inhaling steam is tobacco related?

That does need to be thrown out. Anyone with half an IQ can see that there isn't any tobacco in a vaper.
 
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Racehorse

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I guess I don't see why this would be upsetting. This is an adversarial proceeding and FDA lawyers aren't going to wag their tails and roll over like Golden Retrievers.

Exactly. I for one never thought they would just say "okay, you win".

Which is why just responding to all this with "this sucks" doesn't really accomplish anything. A thoughtful analysis of some of the phrases they have used, and where they are wrong (as well as where the DEFENDANTS need to strengthen their case and get some ducks in a row because it can always be done better) seems like it would be useful. ??

I'm sure the defendant lawyers will learn something from reading the decision and tweak their approach accordingly for future battles.

Legal initiatives are, again, a PROCESS. It takes time and sometimes many years. And lots of money.

Again if the vaping industry had centralized early on, and pooled resources, and had a very clear leadership, I think there would have been a lot more $$ in a pot somewhere, not to mention a lot more input, resource-sharing, education, and better "brain trust huddling". In a way many were just riding on a high of selling, while the getting was good, and didn't really have much thought for the future. (some who thought that way will be out of business shortly of course.......which isn't the end of the world for them, since they appear to be the get in get out type of businesses anyway).

The ones that are in it for the long haul....Big Vaping......will have to continue to bring lawsuits, put forward studies, etc.

I have never been one to get "bogged down" in process. When you do that life becomes pretty unmanageable in general.

Maybe people have lost their ABILITY for long haul. I know couples who work on problems and there were many nights they stayed up all night, until they really were able to keep communicating and solving things......and that is sometimes an on-going process.

People who just get emotionally angry, and throw up hands..... there is no longevity to that approach. Most problems in life are not solved with FINGER SNAPPING speed. :)

I guess I'm older so used to waiting it out........sort of like camping and it rains for the first 2 days straight........you keep on keepin on...........
 

Racehorse

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The other thing is that legal process is like politics in the sense that you have to be very astute and have the right words because it is very difficult to just change the opposition's mind(s).

I got a lot of insight into the process by reading and listening to audio tapes by Gerry Spence. There is a reason why he is in the Trial Lawyers Hall of Fame. "Spence has never lost a criminal case either as a prosecutor or a defense attorney. He has not lost a civil case since 1969...."

When you read about the way he thinks and responds you start to understand how to win. It's not about foot stomping and anger

There are other equally brilliant attorneys, but all of them have certain things in common, and that is that they really understand PEOPLE.

One of the audio books I had was How to Argue & Win Every Time: At Home, At Work, In Court, Everywhere, Everyday

Many politicians who huff and puff, as well as advocates for any cause, should read it. Beause huffing and puffing doesn't get the job done.....all it does is alienate. It takes actual compassion to understand other people and how they think and feel.....not hate and anger.
 

bobwho77

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Exactly. I for one never thought they would just say "okay, you win".

Which is why just responding to all this with "this sucks" doesn't really accomplish anything. A thoughtful analysis of some of the phrases they have used, and where they are wrong (as well as where the DEFENDANTS need to strengthen their case and get some ducks in a row because it can always be done better) seems like it would be useful. ??

I'm sure the defendant lawyers will learn something from reading the decision and tweak their approach accordingly for future battles.

Legal initiatives are, again, a PROCESS. It takes time and sometimes many years. And lots of money.

Again if the vaping industry had centralized early on, and pooled resources, and had a very clear leadership, I think there would have been a lot more $$ in a pot somewhere, not to mention a lot more input, resource-sharing, education, and better "brain trust huddling". In a way many were just riding on a high of selling, while the getting was good, and didn't really have much thought for the future. (some who thought that way will be out of business shortly of course.......which isn't the end of the world for them, since they appear to be the get in get out type of businesses anyway).

The ones that are in it for the long haul....Big Vaping......will have to continue to bring lawsuits, put forward studies, etc.

I have never been one to get "bogged down" in process. When you do that life becomes pretty unmanageable in general.

Maybe people have lost their ABILITY for long haul. I know couples who work on problems and there were many nights they stayed up all night, until they really were able to keep communicating and solving things......and that is sometimes an on-going process.

People who just get emotionally angry, and throw up hands..... there is no longevity to that approach. Most problems in life are not solved with FINGER SNAPPING speed. :)

I guess I'm older so used to waiting it out........sort of like camping and it rains for the first 2 days straight........you keep on keepin on...........
I understand your points, but what (at this point in the process) can I do? I'm not going to be involved in the court proceedings, so all I can do is watch.
If you read the FDA filing, and didn't say to yourself on some level "Jeez! What a load of BS!" before you went on to a more scholarly analysis, then I might have doubts that you're actually human. (or you're a lawyer, which is even worse) /s/
 

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It doesn't matter if they are or arent' cigarettes. You're missing the point. They could be moondrops or fountain of youth inhalers........my point was that the FDA is saying they already went thru all that "this is safe!" song and dance before, and it turned out very badly for everybody.

They are not going to make that mistake again.

IF you look at the Table of Authorities, Federal Cases, you can see where they are going.....

Section 918 of the FD&C act required the FDA to submit a report and examine how the FDA could regulate, promote and encourage development of innovative products which assist 1) total abstinence from tobacco products 2) reduction in consumption of tobacco and 3) reduction in harm from tobacco use.

Congress wanted the FDA not to hinder innovation and a market which went toward any of the above goals, but rather, create an environment where innovation was encouraged.

This is what and where vaping lies. (Specifically category 3) The FDA is not taking this directive seriously, and instead seeking to hinder innovation and market which goes toward those stated goals.

If the FDA is going this route, at best we are looking at 30 years of nearly a dead stop to this line of innovative products while they do enough studies to make them happy.

It shouldn't matter what happened in the past, what should matter is the spirit of the directive from Congress. I understand wanting some regulation, what I don't understand is literally trying to kill innovation dead, in light of what congress was asking the FDA to do.
 

navigator2011

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The other thing is that legal process is like politics in the sense that you have to be very astute and have the right words because it is very difficult to just change the opposition's mind(s).

I got a lot of insight into the process by reading and listening to audio tapes by Gerry Spence. There is a reason why he is in the Trial Lawyers Hall of Fame. "Spence has never lost a criminal case either as a prosecutor or a defense attorney. He has not lost a civil case since 1969...."

When you read about the way he thinks and responds you start to understand how to win. It's not about foot stomping and anger

There are other equally brilliant attorneys, but all of them have certain things in common, and that is that they really understand PEOPLE.

One of the audio books I had was How to Argue & Win Every Time: At Home, At Work, In Court, Everywhere, Everyday

Many politicians who huff and puff, as well as advocates for any cause, should read it. Beause huffing and puffing doesn't get the job done.....all it does is alienate. It takes actual compassion to understand other people and how they think and feel.....not hate and anger.

^^^^^^^^^
"Like" x 1,000!!!

Because one "Like" is not enough. :D
 

choochoogranny

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What I would like to know IS how is a rogue regulatory agency reigned in? How does one get 40 some agencies to follow the original intent of their founding? How do we get our Congress to do their job instead of foisting their duties off to these agencies?

At this point in time I do feel those in the Fed. Gov. are working for themselves and not for the Republic.
 

Hightech Redneck

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Haven't researched it yet but several youtube reviewers are reporting a small step in the right direction.
Apparently a federal judge is reported to have said the fda cannot make a manufacturer submit for juice approval multiple times or for label changes.
Basically it was originally understood if you sold a juice in 30, 60 and 120 bottles you would have to submit to have each size approved.
If reported correctly the judge said nope it's the same stuff in a different size bottle so only needs one approval.
I'm hopeful this trend will continue and these regs will be picked apart piece by piece.
As I mentioned it has been stated several places but I have not been able to confirm it yet.
 

squee

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Haven't researched it yet but several youtube reviewers are reporting a small step in the right direction.
Apparently a federal judge is reported to have said the fda cannot make a manufacturer submit for juice approval multiple times or for label changes.
Basically it was originally understood if you sold a juice in 30, 60 and 120 bottles you would have to submit to have each size approved.
If reported correctly the judge said nope it's the same stuff in a different size bottle so only needs one approval.
I'm hopeful this trend will continue and these regs will be picked apart piece by piece.
As I mentioned it has been stated several places but I have not been able to confirm it yet.
No, it applies to label changes only - not to product size differences

Federal judge rules label change does not make for new tobacco product
 

Lessifer

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