Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Sun Vaporer]

Today, SE filed a supplemental brief in support of not rendering their case moot due to the newly signed legislation.

We will now await a reply from the FDA


-------------Sun

[Sun Vaporer]

Today, Judge Leon granted SE's Request to file their Supplemental Motion and Brief in Support thereof and further ordered the FDA to file any Reply by July 6, 2009.


---------Sun

[Bones]

Anytime new legislation is passed or new case law comes down during the pendency of a case, the parties are mandated to apprise the Court. This new legistlation was brought up repeatedly during the May 15th hearing and I am sure Judge Leon expected a Supplemental filing by the parties if the legislation passed----so it really is just the case taking its normal path and can not be viewed as any reflection of how the Court will ultimately rule------------Sun

OK well in honor of my 200th post - I'll just be mostly optimistic - I see a lot of wording that I really like in there -

I'll just go happily work in my garden for a while now and let the dark clouds roll in and rain on me later -
At which time I'll just dust off my trusty umbrella

[Vicks Vap-oh-Yeah]

Anytime new legislation is passed or new case law comes down during the pendency of a case, the parties are mandated to apprise the Court. This new legistlation was brought up repeatedly during the May 15th hearing and I am sure Judge Leon expected a Supplemental filing by the parties if the legislation passed----so it really is just the case taking its normal path and can not be viewed as any reflection of how the Court will ultimately rule------------Sun

What I think you're saying, here, Sun - is this is simply a rehash of what the court case is about, given additional thought to how the new legislation affects this particular case.

This is not a ruling... the case goes on...new deadlines have been established.

We wait longer.

[webtaxman]

go look at section 9.11 of the act, which addresses "reduced risk" products. The regulatory authority granted in this area is far more lax than even the soft authority granted to the FDA in the case of traditional tobacco products.

Thanks SM--that is the section I was trying to remember whereby e-cigs could continue to still be manufactured, but studies must begin on the safety of the product--BUT while still allowing manufacturing of the product. Thus, no outright ban. SE's law firm did address this issue, but it clearly is not their main argument. The FDA are attacking e-cigs as a drug, a new drug, a new nicotine delivery device. SE's attorneys say "Can't do that." And that makes the assertion even stronger with their interpretation of the new Act- as they just argued.

I agree Sun as this was really a formality. SE's "Instanter" brief (never even heard of "instanter" before now) was well drafted, but it was generally not very persuasive--more like playing the name game which we all know as semantics.

Sun: Do you mind telling us your legal background? You seem to have a firm grasp of all things legal including proper interpretations.

I merely went through a paralegal program offered by the community college several years ago. I never practiced law--except my own filings pertaining to only me. In CA, paralegals must be supervised by an attorney to even call oneself a paralegal. And even then, offering legal advise is considered Unlawful Practice of Law (UPL). Paralegals were taking business away from CA attorneys. CA attorneys said no more legal advice for paralegals. Same thing is going on in Florida right now. Paralegal shops at every corner.

For yvilla: Me thinks I was wrong! As I said, happens a lot.

[yvilla]

For yvilla: Me thinks I was wrong! As I said, happens a lot.

Mike, we can all be wrong at times - no worries there.

But yes, now that we see the whole of SE's supplemental brief, it is crystal clear that they are explicitly claiming "tobacco product" status for ecigs as I thought, and claiming that the new legislation supports their original argument that ecigs should not be regulated as "drug-devices" or as a "drug". The heart of that argument is this paragraph from their brief:

"While the electronic cigarette falls within the definition of a "tobacco product" under the new authority provided by 21 U.S.C. § 321(rr) and the new Section 901, as noted above, the Act explicitly specifies that a "tobacco product," such as the electronic cigarette, cannot be treated by the FDA as a drug, a device, or a combination product. Accordingly, the FDA's decision to classify E-cigarettes as a drug-device combination—a decision made without public notice or opportunity for comment—and to ban the importation of E-cigarettes as an unapproved drug simply lacks any prior statutory basis and directly contradicts the plain language of the new Act."

It will certainly be interesting to see if Judge Leon agrees with them or not. And of course, even if he does and they win this skirmish with the FDA, the battle would be far from over. Next up would be the proper interpretation of the new Act, and how ecigs get treated under that.

[brandeeashlynn]

Well now we have to wait for the FDA response. The FDA I am sure has their best lawyers working on this just as hard as SE does. They will take the SE statements and twist them around to the FDA s benefit. Hopefully the judge will not fall for it but with they way politics are these days I can see him ruling for the FDA. The FDA has alot of influence whether SE likes it or not so we have to play the wait and see game. I hope it goes in SE favor but only time will tell.

[Sun Vaporer]

Today, SE filed it Brief supplementing the legal authority it cited in its original pleadings to the Court in light of the passage of the new Tobacco Control Act.



The FDA has until July 6, 2009 to respond. I would expect NJOY to also file supplements. After that the Court will issue a ruling.


Sun

[TropicalBob]

I agree that it belongs in a new category -- not drug, not tobacco. It's a novelty. A toy. The problem for us is that too many sellers advertised false claims for too long, drawing regulatory attention and initiating that letter from Sen. Lautenberg to the FDA demanding a full ban. It is probably too late now to change the stripes on this skunk.

The only real issue I think this suit contains is whether the FDA followed protocol before and at seizure of shipments. And it's hard to think they'd make a mistake. This was not a precipitous action, after all. It had been considered for many months; emails were carefully worded after the law was studied, etc. The FDA knew exactly what it was doing.

I believe Sun has hinted that the lack of a quick decision for injunctive relief means the judge knows his ruling will have a major impact on this new industry. His judgment will become e-smoking law. I'm glad he's taking his time. I hope he offers clear guidelines on what is and is not allowed into the country.

[yvilla]

Basically, they seem to be arguing that no matter the new law, e-cigs are still a tobacco product. Because they use a constituent of tobacco. Nicotine.

That also makes the lozenge, gum, nasal spray, et all, tobacco products, too, by the same logic. And they aren't. They are drugs, because nicotine is a drug being used to treat the medical condition known as nicotine dependence.

How is the e-cig different in the abstract from NRT drug products? It delivers the same drug, by use of a device. Keep in mind that lawyers can, and will, argue anything. Anything! But surely it's evident here that e-cig=tobacco cig is stretching reality a bit. And do we really want all the restrictions and taxes we'd get from such a decision?

Eagerly awaiting the verdict here so we can move on -- one direction or the other. After losing in Congress, this the bottom of the ninth for us.

TBob, you ask how is the ecig different from NRT drug products. The answer to that is their intended use. The pharmaceutical nicotine lozenge, gum, nasal spray products are all specifically designed, formulated and intended for use solely for smoking cessation purposes. They are all packaged with instructions to that effect, and are recommended only for short term use.

Of course someone could and people do use them for longer than intended, but that is not the issue. It is the intended use that makes them drug products, not the unintended uses.

The ecig, on the other hand, is intended to be used as a smoking alternative - for long term use and enjoyment. Harm reduction, yes for sure, but smoking cessation no. Again, some people may decide to use them only as a short term aid to total smoking cessation, but that is not their primary intended use.

This is in fact the same difference between your Stonewall dissolvables and the pharmaceutical lozenge - the Stonewall is a tobacco product, intended as a smoking alternative, and the lozenge is an NRT drug product, intended for smoking cessation.

As for the fact that there is no actual tobacco in ecigs, and they use only the liquid nicotine extracted form tobacco, how is that any different from the fact that there is no coffee bean or plant material in a cup of coffee, which uses solely the liquid extracted from the bean? Liquid coffee is most definitely still a "coffee product".

And those who have experimented with making their own eliquid from rolling tobacco, or from cigars or snus, you included, are they not using a "tobacco product" with their ecigs? The majority using commericially extracted nicotine liquid are not automagically using a "drug" just because they buy it already extracted rather than going DIY.