FDA Let's talk legal theory. (Section 910, in particular)

[rico942]

Secondly, I'm sooooooo hoping that Judge Leon is still sitting on the bench in DC, as cases are typically heard there for challenges like this. Judge Leon seems to love to bat down the FDA every chance he gets, and watching him do it again would be extremely satisfying.

According to his Wiki page, he seems to be still on the bench at age 67 ...

We all know about this ruling ...

In January 2010, Judge Leon preliminarily enjoined the Food and Drug Administration from blocking the importation of electronic cigarettes

This one was a pleasant surprise ...

On November 7, 2011, Judge Leon issued a preliminary injunction against the U.S. Food and Drug Administration (FDA) for ordering graphic images on cigarette packs. On February 29, 2012, Judge Leon's final ruling held that the graphic images & statements violated the commercial right to free speech, citing the first amendment of the constitution.

 

[StormFinch]

According to his Wiki page, he seems to be still on the bench at age 67 ...

We all know about this ruling ...



This one was a pleasant surprise ...

Heh, and don't forget about his ruling on two of the FDA tobacco advisory council having ties to pharma.

Here's a good article summing up the whole Leon vs. FDA thing. Still not wholly accurate on the e-cig subject, but better than some.
Tobacco Industry Batting a Thousand With Federal Judge, While FDA Strikes Out - FairWarning

 

[AKs0n-]

I would just like to ask...
How do they get away with such blatant failures committed and admitted w/o anyone suing the living .... out of them as is? Are they really that above the Law? To me this is absolute insanity how many are living dependant on such medications and nobody has sued over such. This sort of addiction destroys families and lives and now this all out war on nicotine/ecigs/cigars blows my mind...

 

[KODIAK (TM)]

...are they really that above the Law?

Err... yes?

I don't mean to be flippant but law is quite "fluid" where the FDA is concerned. Like all government agencies tasked with looking out for the inherently stupid these bureaucracies evolve into their own fiefdoms immune from everyone except the proverbial "act of congress".

And here we are.

 

[AKs0n-]

Err... yes?

I don't mean to be flippant but law is quite "fluid" where the FDA is concerned. Like all government agencies tasked with looking out for the inherently stupid these bureaucracies evolve into their own fiefdoms immune from everyone except the proverbial "act of congress".

And here we are.

Would it be a waste of time & effort to sue on these grounds? Personaly Im extremely annoyed w/ this situation even more so than the ecig & cigar issue. Just due to how many American lives have been damaged from the FDA's actions.

 

[inter_ceptor00]

I have a few questions to throw out there, such as do these regulation only apply to interstate sales or is that just for certain parts of it?
Second, how can they regulate vapes and liquids as "ENDS" and the components/parts if we were to manufacture them without them being intended for use with the tobacco at all? How can a vape with only VG/PG liquid and flavoring be considered made from tobacco? Now you just have an Electronic VG/PG and Flavoring Delivery System, or an EVPFDG. If sold and marketed as such, wouldn't the intended use change?

 

[KODIAK (TM)]

how can they regulate vapes and liquids as "ENDS" and the components/parts if we were to manufacture them without them being intended for use with the tobacco at all?

They are simply trying to legislate "behavior". If you vape 100% VG just to watch the clouds it still looks like "smoke". And good citizens in 2016 know that anything remotely resembling the act of smoking is abhorrent, disgusting and sets the wrong example for the kiddies. It's really that simple.

Social Engineering. How far we've come, eh?

 

[Verb]

I have a few questions to throw out there, such as do these regulation only apply to interstate sales or is that just for certain parts of it?
Second, how can they regulate vapes and liquids as "ENDS" and the components/parts if we were to manufacture them without them being intended for use with the tobacco at all? How can a vape with only VG/PG liquid and flavoring be considered made from tobacco? Now you just have an Electronic VG/PG and Flavoring Delivery System, or an EVPFDG. If sold and marketed as such, wouldn't the intended use change?

If the manufacturer and retailer are not in anyway associated with nicotine containing products or products to be used with nicotine, they have a chance. They might still be raided and have their lives turned upside-down, but they should be clear of the regs. If a shop tries to sell both nicotine containing and nicotine free vapor products, the deeming regs indicate the FDA will conclude it is reasonable to believe the end user is going to add nicotine to the nicotine free product. Therefore, the nicotine free product is a component of a nicotine delivery system.

 

[skoony]

If the manufacturer and retailer are not in anyway associated with nicotine containing products or products to be used with nicotine, they have a chance.

Quite right if there products are used as advertised. It's what happens if there products are
not used as advertised and wind up non compliant under the deeming regs.
Regards
Mike

 

[Verb]

Quite right if there products are used as advertised. It's what happens if there products are
not used as advertised and wind up non compliant under the deeming regs.
Regards
Mike

They might still get raided...

It's in there for the future, but they need to make sure their grip is good and tight before playing that card. As is, air is a tobacco product. There aren't any damages till they go that route. They'll keep that part of the regs out of the courtroom for the time being.

If there are retailer(s) and manufacturer(s) independent of the curent industry and the future nicotine vape industry, and are very careful with their words, they are legal.

Note: I'm not a lawyer.

 

[nomore stinkies]

I always felt that we should go after the "medical" aspect of ecigarettes when I first joined ECF. I had a bad feeling about the TCA and our beloved ecigs. I kept saying they will get us. The proof that they actually are a quit aid was also doomed because of the amount of time research takes and the rhetoric from the antz people. It's amazing to me that we use the same FDA approved nicotine as BP does but because we use a different "route" we are categorized in the leaf tobacco section. What happens if they are eventually proven (to the non believers) to aid in the cessation of smoking (which yes I know they are- I am living proof)? Then what? I just want to shake some sense into them. We are not inhaling smoke from burnt tobacco leaves for gods sake. Oh I just want to ....................

 

[skoony]

If there are retailer(s) and manufacturer(s) independent of the curent industry and the future nicotine vape industry, and are very careful with their words, they are legal.

Intended use includes actual use now. The company would have to prove to the FDA
they didn't know their products were being used in non-compliant products. The FDA
is the sole arbitrator of that decision.

The actual use doctrine if used successfully by the FDA will become the template
for other government agencies to use. Legal precedent is a important mechanism.
If successful it means that sometime in the not to distant future all that glassware
labeled for tobacco use only (,,nudge,nudge) will be history. The legal protection
they now have to be on the market will be voided by the legal precedent created by
the Intended use/actual use doctrine. Careful words or not manufacturers will be
walking a fine line in the future.

IMHO one must also look at the big picture not just at the vaper/FDA room.
Things that happen in one room can and do affect what happens in the rest of the house.
What's good for the goose is good for the gander.

Regards
Mike

 

[nicnik]

EDIT: Never mind. Already mentioned in the thread.

 

[SmokeFree]

And good citizens in 2016 know that anything remotely resembling the act of smoking is abhorrent, disgusting and sets the wrong example for the kiddies. It's really that simple.

Except for Hollywood, who loves and advertises smoking in movies, that all kids see. Ironic that CA hates smoking.

Also ironic that the FDA loves smoking.

 

[bigdancehawk]

Seriously though, legal professionals weigh in on this here:

1.) Has the FDA made any press releases on how hardware is distinct from a pipe and justifiably treatable like a cigarette filter or paper? What is their argument?

2.) Is there anything in FSPTCA justifying the grandfather date? If they don't specify in the law itself why that date is there or what it's significance is, correct me if I'm wrong but no judge is going to uphold something that arbitrary in the first place.

3.) Has section 910 been challenged by any tobacco companies thusfar regarding cigarettes and smokeless tobacco? If so, what is the case name and bluebook citation?

The FDA has taken the position that pipes are components of tobacco products and are therefore going to be regulated as tobacco products.

 

[bigdancehawk]

First off, I'd say I'm glad that between CASAA, SFATA, AVA, et al. we have more lawyers involved than we can shake a stick at, some who used to work for the FDA so they know how they think.

Secondly, I'm sooooooo hoping that Judge Leon is still sitting on the bench in DC, as cases are typically heard there for challenges like this. Judge Leon seems to love to bat down the FDA every chance he gets, and watching him do it again would be extremely satisfying.

There are 15 judges in that District. I believe cases are assigned on a rotating basis. So we have a 1 in 15 chance of drawing judge Leon.

 

[zoiDman]

There are 15 judges in that District. I believe cases are assigned on a rotating basis. So we have a 1 in 15 chance of drawing judge Leon.

Judges, at all levels, tend to have Areas of expertise. And so, as a General Rule, will be given cases to Hear based on the type of Litigation that is being sought.

Of course, this isn't a Hard-n-Fast rule. And case load and sometimes Judge Shopping can play a role in Who hears What.

 

[bigdancehawk]

Judges, at all levels, tend to have Areas of expertise. And so, as a General Rule, will be given cases to Hear based on the type of Litigation that is being sought.

Of course, this isn't a Hard-n-Fast rule. And case load and sometimes Judge Shopping can play a role in Who hears What.

You've inspired me to dig a little deeper. According to D.C. District Court Rule 40.3, cases are assigned on a random basis.

 

[zoiDman]

You've inspired me to dig a little deeper. According to D.C. District Court Rule 40.3, cases are assigned on a random basis.

Oh I'm sure that there is something that says that it is supposed to be a Random Process.

And that this ...

Tobacco Industry Batting a Thousand With Federal Judge, While FDA Strikes Out - FairWarning

is merely the outcome of a Stochastic Process.

 

[bigdancehawk]

Oh I'm sure that there is something that says that it is supposed to be a Random Process.

And that this ...

Tobacco Industry Batting a Thousand With Federal Judge, While FDA Strikes Out - FairWarning

is merely the outcome of a Stochastic Process.

Procedures vary from district to district and also some have changed over time. There was a period of time in the D.C. district when not all cases were assigned randomly. Instead, the chief judge or a committee of judges would assign unusually complex or difficult cases based on experience and expertise in particular areas of law. (E.g., patent law isn't something most lawyers/judges know much about.) But most districts didn't follow that practice. Based on the current rule, it appears that the D.C. district has reverted to random assignments. I tend to be mistrustful and skeptical, but I seriously doubt there's any funny business going on.