Article: How will the FSPTCA Impact the Ecig Industry?

[PhiHalcyon]

This article is by an attorney from Duane Morris (one of the top 100 largest law firms in the world), and was originally published on the Food and Drug Law Institute's web page. It is perhaps the best synopsis of the ecig situation that I have come across. There is also an interesting ad on the last page.

http://www.duanemorris.com/articles/static/chowdhury_fdliupdate_0909.pdf

 

[Janetda]

Wow Phil, that is a really good read. Thanks. The article is a cogent summation of the situation. I think there are several personalities in the anti-tobacco and anti-ecig movements that spark suspicion regarding motives and because of that many of us start to think the world is against e-cigs for dark reasons. It's nice to see a well balanced article that lays out where we are legally and how we got there.

Thanks again.

 

[ddavelarsen]

Yes, that is a very objective view of the issue. It doesn't give me warm fuzzies though. I hope that some of the larger players in this industry (though not the mall ninja ripoff companies, who would likely ensure crap products are the norm) will step up to support our safer life. I am so happy for my vaping, so pleased that I no longer smoke, ecstatic that I have found a way past smoking -- that this whole legal turf war just makes me feel ill and unhappy. I wish -- I really wish! -- that I could swear in frustration right now. Grrrr! Do-gooder jerks need a life of their own.

But I sure appreciate Mr Chowdhury's calm and thorough description of the issue. Thank you very much for the link.

 

[rothenbj]

This article is by an attorney from Duane Morris (one of the top 100 largest law firms in the world), and was originally published on the Food and Drug Law Institute's web page. It is perhaps the best synopsis of the ecig situation that I have come across. There is also an interesting ad on the last page.

http://www.duanemorris.com/articles/static/chowdhury_fdliupdate_0909.pdf

Excellent article. Pretty well sums up the e cig environment.

Yes, those litigation lawyers have to get together and figure out where their next gravy train is coming from.

 

[Vicks Vap-oh-Yeah]

But, the article did leave out one important thing...the rumors (and yes, rumors are not fact, I realize that) that the FDA is giving any and all PV manufacturers and even Spikey's VI group some serious run-around in starting the application process and/or the necessary testing needed to prove their safety and efficacy.

It would be one thing if they were up-front about such things, but they insist on federally-approved studies and the drug-delivery device application, but they are NOT allowing the manufacturers the opportunity to go through their process. Their prejudice on the PV is made crystal clear in their actions.

 

[PhiHalcyon]

Janet, Dave, and Rothen: You're welcome, and I agree with each of your comments.

Vicks: It is possible that the prejudice perceived against the ecig/PV could be absolute. One left-wing blogger recently had this to say about the ecig:

"So what we have here is a novel unregulated drug delivery system involving inhaled propylene glycol that is manufactured in China, a nation famous for the quality and regulation of its regulated Heparin supply. It is perfectly designed for sale to children and to Darwin award wannabes.

The good news is that the GOP no longer controls the FDA. That doesn't mean we can go back to sleep. The GOP will be back, and with Palin and Bachman in control it will be worse than ever. This beast needs to be driven back into its cage." ( Gordon's Notes: Smart Smoker e-cigarette: From China without regulation ) (Emphasis mine.)

(If this statement is representative of the left-wing viewpoint, then the contents of that conference advertisment - on the last page of the OP article - should be perceived as alarming.)

On the other hand, there are other possible explanations for the rumored runaround you mentioned. Sun previously mentioned something about this with one or more parties getting the runaround in trying to seek a new, or modified risk, tobacco product approval; and if this is what you are referring to, then the problem is that the FDA cannot regulate the ecig as a tobacco product (in my opinion), and/or is not even remotely interested in doing so.

As for seeking an approval for a new device and drug product, I believe that this is a task reserved for those with patents - or at least patents pending. I know that Sottera(Njoy) has a patent pending (as do Ruyan, Phillip Morris, and possibly others). This, combined with CVS's curious willingness to carry the Njoy product, have given me a speck of hope that some measure of reason and compassion will prevail.

Time will tell whether the FDA's enforcement actions will be all-consuming, or leave a survivor or two (and whether Mr. Chowdhury's long-run optimism will have any short-run manifestations or promise), but, just in case, I have prepared myself for the worst.

 

[ChipCurtis]

It is possible that the prejudice perceived against the ecig/PV could be absolute. One left-wing blogger recently had this to say about the ecig:

"So what we have here is a novel unregulated drug delivery system involving inhaled propylene glycol that is manufactured in China, a nation famous for the quality and regulation of its regulated Heparin supply. It is perfectly designed for sale to children and to Darwin award wannabes.

The good news is that the GOP no longer controls the FDA. That doesn't mean we can go back to sleep. The GOP will be back, and with Palin and Bachman in control it will be worse than ever. This beast needs to be driven back into its cage."

You are correct in your lead-off statement to this blogger's quote. This is NOT a liberal vs conservative, or Democrat vs Republican issue. When it comes to the issue of smoking (or anything that looks like it), the lawmakers of either party are in lockstep. There is too much money at stake here, too many Phillip Morris payoffs to politicians are at stake. If you think the GOP is going to save you on this, you are sadly and tragically mistaken. A GOP backlash will not save your ..., it will only make things WORSE.

Many smart GOP politicians are salivating at the idea of hordes of clueless Glenn Beck-like angry citizens 'coming back to the GOP' to save them over these kind of 'control and government issues'. Don't hold your breath, don't waste your time. The Democrats are basically "GOP-lite", just be glad it's them who are doing this lawmaking and not the GOP. The Democrats who are currently holding power are doing this lawmking to placate the GOP, not oppose them. This e-cig issue has the potential to be the single most important issue that puts the GOP back in power, and when that happens, things will only get more and more draconian. Look at what happened to America under GW Bush, do you think there sill be a GOP savior that will put all this stuff right? Don't count on it.

Just let the dems do what they gotta do to hold off the GOP hordes at the gates. Stock up on atty's and e-juice while the lawyers and politicians wrestle one another in the statehouses and courtrooms over semantic word games in the coming months. It will take a while for all this legal wrangling to get ironed out. In the meantime do whatever it takes to ensure that you won't be tarring up your lungs anymore and won't be putting $$$ into Phillip Morris' (and hence into these anti-smoking politicians') coffers.

 

[PhiHalcyon]

Chip,

Since most of us understand how the ecig threatens certain special interests from both sides of the aisle, your near brush with the cerebral self-combustion of party-think was a danger you could have avoided.

 

[jj2]

I wish -- I really wish! -- that I could swear in frustration right now.

And that is how the swearing is done.

Well, I feel better.

 

[PlanetScribbles]

The GOP is the whole reason America is the country it has become today. They live for big business, capitalism is their wet dream. Thank goodness for the current term of relief.

 

[ChipCurtis]

Chip,

Since most of us understand how the ecig threatens certain special interests from both sides of the aisle, your near brush with the cerebral self-combustion of party-think was a danger you could have avoided.

When I implied that "True Balls-To-The-Wall GOP Politics" is worse than "GOP-Lite Disguised as Democrat" I wasn't taking one party side over the other, they're both corrupt as hell. I was just trying to inform how this current system works, but I guess you all know that already. Okay, sorry for ranting then. I don't have any "party-think" allegiances to burden myself with. I just think we all need to do what's best for us, because I've seen this political cycle happen too many times to get f***ed by it over and over again. One has to take reasoned and intelligent measures to protect oneself from the ignorant, if that's all one can really do.

 

[ddavelarsen]

The original article seems to have disappeared. Anyone save the pdf? I thought I had but it's gone and now I can't find it online again. Any help appreciated!

 

[Janetda]

Here ya go, I think this is it.

 

[shopgirl284]

It doesn't matter who is in office. It is all about the money. The best options for the continuation of PVs are:

That enough large companies with great lawyers and lobbyist are able to make enough profit off of PVs to make it worth their time to defend it.

OR

Through taxation, the government finds the continued production and resulting taxable income of PVs to be worthy of their support.

Hey, it has worked for alcohol and caffeine.

The only other option is that it creates so little income that noone feels it is worth wasting time the government could spend on issues that do create income for them or their large supporter's companies. Except it would allow the activist to scream loudly and unanswered about protecting us from ourselves.

It does make you wonder where are all those "activist" to protect us from ourselves when it comes to the horrible affects of alcohol and caffeine?