FDA Sued Over Electronic Cigarette Embargo

[Sun Vaporer]

Fair enough...Counsel could very well want these letters to be sent...I would just want to be 100% certain...There are all kinds of unforeseen issues that letters could raise....(especially considering that many writers may be the same people who have publicly posted about the harm SE has done with their marketing claims)...

I was unaware that attorney's in the Federal District Courts could not solicit letters, do you have a cite for this? I am not disagreeing here, just want to educate myself a bit...

Chuck--Counsel can only submit to the Docket by way of pleadings--a letter from the public is not an admissible pleading. F.R.C.P. 11 (b)(3):

(3) the factual contentions have evidentiary support or, if specifically so identified, will likely have evidentiary support after a reasonable opportunity for further investigation or discovery.

Our submitions are not factual contentions that will ever lead to evidentiary support-----that is a given--------

Again people do as you see fit and do not reley on SE counsel to speak for you--Kate is right there. Judges and Clerks are people just like everyone else and can and do read between the lines. -----Sun

[Faethe]

I, for one, would not want my PV categorized as a tobacco product. Regardless of the type of product, anything associated with tobacco gets attacked relentlessly, especially with the 'think of the children' types. Cigarettes, chewing tobacco, snuff, snus, tobacco 'candies', you name it, all have been under fire at some point by various groups, and all have a stigma associated with them. Filing PV's as a tobacco product will doom it as 'guilt by association'.

Ivisi

Well, the other thing to consider is that if this gets categorized as tobacco, Phillip Morris will inevitably start manufacturing these. Then, of course, they will sell for $150 each, 30% of which will be tax. Then Phillip Morris will established guidelines concerning their manufacture and distribution which will neatly clip China right out of the whole equation.

So I don't know.

[J W in Texas]

What are the long term implications of being a tobacco product in the US?

Is the outlook attractive?

I think so many people are just so happy to see this fight get started that we are too quick to agree to let them be considered tobacco. I would like them to be considered 'other' but most of us are tired of them being classified as in a no-man's-land that can be easily picked off at customs on the whim of the fda who still doesn't have any authority.

As always, be careful what we wish for...

Also, I predict this will be the longest thread ever...

[TropicalBob]

Kate is asking all the right questions, folks. But, then, this might be the classic lose-lose proposition. If the ban is not lifted, our supply will dry up. If we're a tobacco product, get ready for all that that means -- all that we fled when we moved to e-cigs.

And the possibility remains of an FDA ban once that agency regulates tobacco products.

[jmoney]

There are a few things that are very important here:

1. The judge will more than likely entertain that hundreds of letters that come his way in the next couple days, but here is the problem. Just like SE's outrageous claims when individuals start making the claim that these are a smoking cessation device(saying you quit cigarettes is pretty much the same thing) then you are agreeing that these are a new drug and will need FDA approval just like every other cessation product. If and when individuals decide to start to write these letters make it clear that this is a smoking alternative that you feel is safer, not a device to quit smoking.
2. PVs are NOT tobacco products, this can be debated over and over again, but the plain and simnple fact is that a tobacco product is defined as a product containing the plant(tobacco) which PVs do not. The nicotine my be derived from the source, but the law currently does not have any provisions in it for this type of thing. (Nicowater and other products simply failed on the basis of their claims)
3. Do not appeal to the judge on the manner that these should be legal, that isn't his decision. As Kate said this will be an important case, as it will more than likely end up being the basis for what vaping is constituted as. What is important here is the fact that many legitimate AMERICAN business owners are being wrongfully punished. There is no law that these devices are illegal. Has the FDA even accepted an application for FDA approval from one of these business? My guess would be no, the prudent thing to do in this situation would be for the temporary release of all parcels currently being "illegally" held in customs then allow a time period for these devices to be tested.

these are just my thoughts let me know what you think.

[strayling]

But, then, this might be the classic lose-lose proposition.

Bah, you see everything as a lose-lose proposition. Change the record.

[Ivisi]

Well, the other thing to consider is that if this gets categorized as tobacco, Phillip Morris will inevitably start manufacturing these. Then, of course, they will sell for $150 each, 30% of which will be tax. Then Phillip Morris will established guidelines concerning their manufacture and distribution which will neatly clip China right out of the whole equation.

So I don't know.

Right, and one last thing to consider is that, if the PV is classified as a 'tobacco products', then it falls under the same usage bans that cigarettes currently fall under. So, the more I think about it, the more I agree that classification of the device as a 'tobacco product' does not serve our best interests.

However, now that I'm looking at some details, and not completely understanding legalese (the english language as translated by a lawyer), they could be arguing that they should be regulated 'like' tobacco products, but not 'as' tobacco products'.

I guess it depends on what your definition of 'is' is.

Ivisi

P.S. 10 brownie points to the first person who gets the reference in my last sentence.

[chuck7403]

Sun:

I understand that the letters will not become part of the record, but is there a rule that prevents SE's lawyers from asking the public to write letters?

From quickly skimming the complaint I see two issues: (1) the FDA did not follow the procedures as required by the Administrative Procedure Act (and or its organic act), and (2) whether a preliminary injunction/temporary restraining order should be issued.

It is my understanding that usually before issuing a rule an administrative agency must give public notice and an opportunity for public comment. It is this public comment phase where letters should be written...SE is arguing that the FDA did not follow these procedures...

I do not know whether an "import alert" on a new product requires public comment and notice...

I completely agree with you that the court should be fully aware of the importance of this product, I am not sure, however, that writing letters is the best method...

[Wildsky]

I'm pretty sure the lawyers for SE have thought over the whole "tobacco" thing.

Sun, why don't you email them and ask their stand on that?;

[jmoney]

Sun:

I understand that the letters will not become part of the record, but is there a rule that prevents SE's lawyers from asking the public to write letters?

From quickly skimming the complaint I see two issues: (1) the FDA did not follow the procedures as required by the Administrative Procedure Act (and or its organic act), and (2) whether a preliminary injunction/temporary restraining order should be issued.

It is my understanding that usually before issuing a rule an administrative agency must give public notice and an opportunity for public comment. It is this public comment phase where letters should be written...SE is arguing that the FDA did not follow these procedures...

I do not know whether an "import alert" on a new product requires public comment and notice...

I completely agree with you that the court should be fully aware of the importance of this product, I am not sure, however, that writing letters is the best method...

If the judge allows it they can be solicited.

Everything else...I believe you are correct.