FDA SFATA submits cogent comments to FDA opposing deeming regulation

[Bill Godshall]

SFATA submits cogent comments to FDA opposing deeming regulation
http://sfata.org/wp-content/uploads/2014/08/FDA_2014_N_0189_SFATA_Comments.pdf


Looks like SFATA is preparing to sue the FDA if/when the deeming regulation is approved.

 

[Kent C]

Site is down right now.....for me.... I'd like to see the Institute for Justice get involved in the law suit, if/when it comes to that.


edit: back up now! read later.....

 

[dragonpuff]

This comment is superb thank you digging this up Bill!

 

[ClippinWings]

THAT is a fantastic comment. Best I've read.

 

[Jman8]

Best comment IMO as well.

 

[nomore stinkies]

SFATA submits cogent comments to FDA opposing deeming regulation
http://sfata.org/wp-content/uploads/2014/08/FDA_2014_N_0189_SFATA_Comments.pdf


Looks like SFATA is preparing to sue the FDA if/when the deeming regulation is approved.

I can't believe I didn't see this thread earlier. This is what I have been waiting for!!! Finally something in a more positive light. AND I finally received an answer to my question: Why are they considered a "tobacco product". Page 3.They are not. Cogent...very cogent!!!!! Made my day. I'm going to see if I can become a member. (I tried to subscribe and I couldn't get through it without an error popping up- so I sent them an inquiry).

SFATA.org open Issues at a glance and select FDA comments.

This one opens easily

 

[SeniorBoy]

FYI: The letter includes signatures of two attorneys (Counsel of record) for SFATA. These partner attorneys work for Venable LLP, one of the most highly regarded law firms in the nation. With over 600 attorneys, a century of existence, and an expertise in this very issue of regulatory authority and overreach. In a nut shell, these are very high powered attorneys who specialize in law suits against regulatory authorities.

Venable LLP | About Venable

 

[NorthOfAtlanta]

FYI: The letter includes signatures of two attorneys (Counsel of record) for SFATA. These partner attorneys work for Venable LLP, one of the most highly regarded law firms in the nation. With over 600 attorneys, a century of existence, and an expertise in this very issue of regulatory authority and overreach. In a nut shell, these are very high powered attorneys who specialize in law suits against regulatory authorities.

Venable LLP | About Venable

Nice, a not so veiled threat with teeth, I like that.

 

[Endor]

FYI: The letter includes signatures of two attorneys (Counsel of record) for SFATA. These partner attorneys work for Venable LLP, one of the most highly regarded law firms in the nation. With over 600 attorneys, a century of existence, and an expertise in this very issue of regulatory authority and overreach. In a nut shell, these are very high powered attorneys who specialize in law suits against regulatory authorities.

Venable LLP | About Venable

Very good news indeed... it was obvious to me within the first few pages that it was written by attorneys, and clearly aimed at setting up for the inevitable court battle should the FDA continue to regulation. That, alone, provided me a lot of hope, as the courts have not been quick to side with the FDA previously regarding e-cigarettes.

 

[Gato del Jugo]

I see they dedicated 2 full pages to zero-nic, early on in their submission..

 

[Bill Godshall]

As any good lawfirm does, Venable attorneys cited several dozen different potential legal arguments that could be cited/argued if/when the FDA imposes the deeming regulation on vapor products.

I suspect any litigation against FDA would be filed in the DC Federal Court District, and that the case(s) would be assigned to Judge Richard Leon (who struck down FDA's 2009 e-cig ban as unlawful).

Don't know if lawsuit(s) against FDA would be filed before and/or after the FDA issues cease-and-desist letters, as it may be difficult for potential plaintiff(s) to gain "legal standing" in court (to sue the FDA) before the FDA actually bans their products (which probably won't occur until two years after FDA issues the Final Rule for its proposed deeming regulation).

But since Leon's 2010 ruling stated that FDA could regulate e-cigs as "tobacco products" (since they met the FSPTCA's definition of "tobacco product"), I'd be surprised if Leon (or other federal judges) would subsequently rule that e-cigs don't meet the FSPTCA's definition of "tobacco products" (except for non nicotine vapor products).

I suspect that one or more of the following will be the winning legal argument(s) in court (to strike down FDA's deeming regulation):
- FDA grossly misrepresented the scientific evidence about e-cigs,
- FDA failed to consider the enormous economic benefits e-cigs provide consumers and public health,
- FDA failed to consider the huge economic costs imposed by the deeming regs (on e-cig companies, consumers and public health),
- FDA failed to consider the black market impact of the deeming regulation (which is required by the FSPTCA).

Its possible that the courts could strike down this version of FDA's proposed deeming regulation as unlawful, but let the FDA propose a another deeming regulation for e-cigs (similar to how Judge Leon struck down FDA's regulation for graphic warnings on cigarette packs, but not the FSPTCA's statutory requirement, which resulted in two, three or four year delay before FDA proposes new regs).

I also suspect that at least one cigar, hookah and/or pipe tobacco company may sue the FDA if/when the deeming regulation is approved and imposed (although it is uncertain if/how the FDA will regulate large premium cigars).

 

[Nate760]

I suspect that one or more of the following will be the winning legal argument(s) in court (to strike down FDA's deeming regulation):
- FDA grossly misrepresented the scientific evidence about e-cigs,
- FDA failed to consider the enormous economic benefits e-cigs provide consumers and public health,
- FDA failed to consider the huge economic costs imposed by the deeming regs (on e-cig companies, consumers and public health),
- FDA failed to consider the black market impact of the deeming regulation (which is required by the FSPTCA).

While it's quite obvious that each of these arguments is correct, none of them actually cuts to the heart of the issue:

1) That the US government and the Big 3 tobacco companies have been running an illegal protection racket since 1998, wherein the latter pays massive annual bribes to the former in exchange for being safely insulated from free-market competition.

2) That since that time, the tobacco policy decisions made by the government's public health agencies have been motivated solely by a concern for maintaining the racket and keeping the bribe money flowing.

3) That those same public health agencies have, since that time, pursued policies whose cumulative results have been more people smoking, fewer people quitting, and more people dying needlessly from smoking-related disease.

4) That those agencies have consciously, willfully, and systematically deceived the congress, the public, and various state and local governments.

 

[Jman8]

Like what Nate is contributing to the discussion, but it would seem to come back to Bill's comments with data that cuts even more to the issue. Though, this is my spin, and stuff I'm fairly certain Bill would vehemently disagree with.

- FDA (and other entities) grossly misrepresented the scientific evidence about combustibles
- nearly everyone that bought into this gross misrepresentation failed to consider the enormous economic benefits anti-smoking programs provide those that orchestrated this campaign and/or currently choose to participate in it
- nearly everyone failed to consider the huge economic costs imposed by excessive/zealous tobacco regulations
- nearly everyone failed to recognize the black market that has sprout up within the combustible market (which is still legal) but is due to ongoing gross misrepresentation of scientific data and those who seek economic benefits (or even entire income) from reparations

All these failures and gross misrepresentations make the eCig issue seem like a cake walk to the zealots amongst us.