FDA Sued Over Electronic Cigarette Embargo

[calligal]

Posted by Bill Godshall over at http://www.e-cigarette-forum.com/forum/campaigning/13151-now-time-act-i-am-serious-updated-28.html

The following e-mail was inadvertantly sent to at least several members of Congress. Looks like the FDA has been planning this for awhile, and next Tuesday could bring very bad news to e-cigarette marketers and users in the US. But the US Senate can still trump the FDA by amending the Waxman/Kennedy legislation to allow e-cigarettes on the market.


From: Zawalick, Heather (CBER) [mailto:Heather.Zawalick@fda.hhs.gov]
Sent: Wednesday, April 29, 2009 4:08 PM
To: Zawalick, Heather (CBER)
Subject: [LIKELY_SPAM]FDA Outreach: FDA Takes Enforcement Action on Electronic Smoking Products, Entering Clearance

Subject/Headline: FDA Takes Enforcement Action on Electronic Smoking Products

Planned Release Date: May 5

Driving Event: Compliance action

Rollout Plan: Extensive rollout planned including press conference at HHS, press release, fact sheet, video for upload to YouTube, podcast, consumer article, consumer Q &A, key message points, internal media Q & A, Op-Ed, photos of products for posting on Internet.

Other background, hidden factors: Action involves three largest distributors. One of the distributors has just sued FDA seeking a restraining order to prevent us from holding their product at the border. There is keen interest in this subject. E-cigarette kiosks are all over town, including Montgomery Mall. They're being advertised as a safer alternative to cigarettes. Our concern is that this might introduce nonusers to nicotine use. This is a drug delivery device. The content of the products have not been analyzed by FDA. To be sold, they would have to be approved by the agency.

Spokespersons: Janet Woodcock and Deborah Autor

Heather Zawalick
FDA/OC/Office of Legislation
301-827-0090
Heather.Zawalick@fda.hhs.gov

 

[esmok-e]

She sent this to herself!!!!!!! Look at the header!

Yeh, yeh, I edited the rest... but the header on the original shows she sent it to herself! I'd like to see the headers from at least one other recipient. Give it up whoever this originated from.

From: Zapthenic, Heather (CBER) [mailto:Heather.Zawalick@fda.hhs.gov]
Sent: Wednesday, April 29, 2009 4:08 PM
To: Zapthenic, Heather (CBER)
Subject: [LIKELY_SPAM]FDA Outreach: FDA Takes Enforcement Action on Electronic Smoking Products, Entering Clearance

Subject/Headline: FDA Takes Illegal Action on Electronic Smoking Products

Planned Release Date: May 5

Driving Event: Compliance with Big tobacco & Big Pharma Directives

Rollout Plan: Extensive rollout planned including press conference at Altria, press release, fact sheet, video for upload to YouTube, podcast, consumer article, consumer Q &A, key message points, internal media Q & A, Op-Ed, photos of these evil products for posting on Internet.

Other background, hidden factors: Action involves three largest distributors. One of the distributors has just sued us seeking a restraining order to prevent us from holding their product at the border. We'll show them! There is keen interest in this subject. E-cigarette kiosks are all over town, including Montgomery Mall. They're popping up like cockroaches. Weto snuff them out before the people learn the truth. They're being advertised as a safer alternative to cigarettes. OMG, the sheer chutzpah! Our concern is that this might introduce smokers to a safer nicotine use. Come on guys, this is a drug delivery device, right? We could make this work. We could get away with this. I want to be a politician and get bonuses for this. The content of the products have not been analyzed by FDA so we don't know what the f*** we're doing. So let's do this and force them to be sold, only AFTER approved by the agency, just like we did with Vioxx.

Spokespersons: Janet Woodencock and Deborah Autistic

Heather Zapthenic
FDA/OC/Office of Legislation
301-827-0090
Heather.Zawalick@fda.hhs.gov

 

[esmok-e]

Me know worry from FDA. Me make stock-market go up and down. We IPO at 1 cent and go high to 25 cents. We move 189,500 shares up and down. We have short and long (and I don't mean batteries). No worries we have 87,790,000 shares to buy and sell and make money both ways. We no even have to sell one Chinese e-cig (which we invented and patented, haha). We burn e-cig from both ends. We set up distribution in Benelux and Greece (we have villas and Swiss bank accounts). FDA no worries, don't worry.

 

[esmok-e]

 

[OutWest]

regarding sending to herself - that's pretty common if all the recipients were BCC'd (usually done when one wants to hide the various email addys from each party that email was sent to).

 

[esmok-e]

regarding sending to herself - that's pretty common if all the recipients were BCC'd (usually done when one wants to hide the various email addys from each party that email was sent to).

Right. Prolly BCC'd. Speaks volumes... maybe it was also "inadvertently" CC'd somewhere. Maybe it was never meant to go out....

 

[Iken]

Extracting nicotine from tobacco is not something you can do in the kitchen. Some friends and I were talking about it the other night and one's a phd chemist. He said to get usable nicotine you either have to have a really big setup that's running tons per hour, or use a complicated process with solvents and acid and alkaline and know what your doing just to get a little bit out of the plant.

If all this info is true and making our own nic is a very complicated process and If the liquid is banned and theres no other way for us to obtain some (which personally I believe we would be able to find a way somehow anyway) and Pm does go ahead with the vaporizer's. Atleast our devices will still be available to us.

Obviously flavored nic liquids will be finished if the bill goes through. A supplier I spoke with was saying if worst comes to worst and and nic liquid does get banned, best thing to do is just stick with selling flavored pg and vg which he does sell. Maybe its time for us to bite the bullet and drop the nicotine.

I been an avid cigarette smoker for almost 15 years. If I didnt get chance to smoke a cigarette for atleast 2 hours, I'd go mad (seriously). I been vaping since January. Twice I completely forgot my liquid when going grocery shopping (the most critical of time lol) but I was fine, no irratebly , no anger, surprisingly nothing of any withdraw symptom.
The bottom line is, that people should give a shot to vaping no nic atleast for 2 days and see how it pans out for them or just start diluting your liquid and use flavors to replace the loss and ween yourself off of nic by halves so you would have nothing to be dependent on. Take the time you have now and see if the chains that bind you, are really not that solid.

 

[LaceyUnderall]

If all this info is true and making our own nic is a very complicated process and If the liquid is banned and theres no other way for us to obtain some (which personally I believe we would be able to find a way somehow anyway) and Pm does go ahead with the vaporizer's. Atleast our devices will still be available to us.

iken - it's been awhile... hello there bud!

in response... this is sad though. from all that i have learned over the past few weeks... this is so sad from an American perspective that one company can come in, manipulate the legislative system, effectively put about 250 small businesses out of business and then do exactly the same thing those small businesses were doing.

yes... at least we will still have our pv's, but at what cost?

and isn't it ironic that many of us felt as if we were being held hostage by tobacco and then we find something that liberates us... only to be taken hostage by them again and just accept it? do you think the next generation of eSmokers are going to feel as liberated as we all have? heck no. do you think PM's eliquids are going to contain as few ingredients as ours do? i think not. OR... do you think they will even let us know what is in the liquid? Definitely not.

they had their chance to do right.

 

[Di]

I agree with Iken,
try to get off the nic liquids

use 2 PV's =
1 with nic liquid as low as you can
the 2nd one qith flavoured 0 nic liquid
alternate the two all thye time,
and every 3 or 4 days, lower the strength of the nic liquid.

you will be surprised how little you miss the nic,
I find, as long as I get good smoke coming out,
I am happy.....

I am down to alternating,
8mg and 0 with mine,
I started a month ago with 12 and 0
so I am doing OK.

try it,

Di .......

 

[OutWest]

^ it makes sense because a big part of the addiction is simply the motions. I've vaped when I really didnt want any more nicotine, simply because of the need for the motions thing and I used to do the same with cigarettes, smoking way more than I wanted. Heck, I've even chain smoked light cigarettes to the point of being ill from too much nicotine.

 

[LaceyUnderall]

I agree with Iken,
try to get off the nic liquids

Sun gave me this idea a month or so back and I am now on 0 nic all day... with a cigs worth of nicotine at nite up until this week... I am right there with you Di... it's the smoke for me... the hand to mouth.

Just further proof that the nicotine is not the main part of the addiction for some. It is the action (and the smoke!). At least for me.

 

[dijohn76]

Even if the Waxman bill passes the senate as written, it still has to be signed by Obama, who can line item veto & is a casual smoker.
Cheer up people- the draconian bush/era is over!

Considering the fact that he is the one that signed the latest cigarette tax increase into law, I don't think I would count to much on him

 

[Russ_and_Mia2112]

Considering the fact that he is the one that signed the latest cigarette tax increase into law, I don't think I would count to much on him

Huge misconception on the part of those that believe Dems/and or liberals are actually concerned with the rights of the people to ingest and partake in things they deem enjoyable. Just look around - you will find a huge number of Democrats in favor of draconian laws against business and citizens who should have the right to smoke, eat and drink what they want.

Not to mention that the line-item veto was ruled unconstitutional years and years ago. I'm definitely not putting any faith into the political class who is under the thumb of the tobacco industry and the pharmaceutical industry - luckily, there are always going to be ways around them, and that is what I am counting on to continue my enjoyment of these products.

 

[esmok-e]

Should the FDA crack down on electronic cigarette vendors? | MercuryNews.com Forums



Vote Now!

 

[Iken]

iken - it's been awhile... hello there bud!

in response... this is sad though. from all that i have learned over the past few weeks... this is so sad from an American perspective that one company can come in, manipulate the legislative system, effectively put about 250 small businesses out of business and then do exactly the same thing those small businesses were doing.

yes... at least we will still have our pv's, but at what cost?

and isn't it ironic that many of us felt as if we were being held hostage by tobacco and then we find something that liberates us... only to be taken hostage by them again and just accept it? do you think the next generation of eSmokers are going to feel as liberated as we all have? heck no. do you think PM's eliquids are going to contain as few ingredients as ours do? i think not. OR... do you think they will even let us know what is in the liquid? Definitely not.

they had their chance to do right.

Hi Lacey Always here and there, Congrats on the 0 nic
Your right,Your absolutely right. Someone a while back asked me how I feel about politics and my beliefs, I couldn't answer that. Because whats going on here with our generation e-smoking is completely wrapped in it. We sought freedom in the land that claims to be free. Just to be shot back down by politics. Where One single solitary company has sway and control of everything related to which it stands.
And mindless drones will give full credit to this corp for "discovering and condoning a safer way to smoke" Meanwhile behind the scenes they butchered everyone else to prime capitalism. Every one of you guys who busted your asse$ for your businesses to succeed. And not only are they killing everyone here, you know they're going to add the classic recipe of addicting drugs including side effects of death to the world. Ugh Politics, Money, Marketing. Its funny how the system portrays Freedom fighters as ruthless evil savages. Ode to America

I agree with Iken,
try to get off the nic liquids

use 2 PV's =
1 with nic liquid as low as you can
the 2nd one qith flavoured 0 nic liquid
alternate the two all thye time,
and every 3 or 4 days, lower the strength of the nic liquid.

you will be surprised how little you miss the nic,
I find, as long as I get good smoke coming out,
I am happy.....

I am down to alternating,
8mg and 0 with mine,
I started a month ago with 12 and 0
so I am doing OK.

try it,

Di .......

I'm so happy for you bunny love!!! Congratulations, What a Great Idea! Thank you I hope everyone else tries this method. Because this subject is inevitable to happen.

 

[skex]

Huge misconception on the part of those that believe Dems/and or liberals are actually concerned with the rights of the people to ingest and partake in things they deem enjoyable. Just look around - you will find a huge number of Democrats in favor of draconian laws against business and citizens who should have the right to smoke, eat and drink what they want.

Not to mention that the line-item veto was ruled unconstitutional years and years ago. I'm definitely not putting any faith into the political class who is under the thumb of the tobacco industry and the pharmaceutical industry - luckily, there are always going to be ways around them, and that is what I am counting on to continue my enjoyment of these products.

Yeah and conservatives have been such leaders on personal freedom wanting to shrink government just to the size to fit in our bedrooms and tell us who how and when to have sex.

Seems to me that "just say no" came from that conservative icon Ronald Reagan's wife and I've not heard any prominent elected republican suggesting that we should decriminalize Cannibis.

Oh and then there is that whole gay marriage thing guess that's not a personal enough freedom to qualify.

Sure there are more than a few democrats who go too far in trying to protect people from their own irresponsible actions and generally I and not a small number of other liberals oppose them.

But to pretend for one second that the Republicans have ever been the champions of personal freedom is utter nonsense.

I am reminded of what Gore Vidal once said about American politics "We have one political party in America with 2 right wings"

Leftists have never been in power in the United States it's always been conservatives.

Now as a practical consideration in this case the Republican's in congress may be our temporary allies due mainly to the fact that their current political ideology seems to consist of nothing more than opposing anything the democrats propose. But this is no indication of their valueing personal freedom. The only freedom that elected Republicans have ever shown any support for has been the freedom for rich .......s and corporations to abuse us peons.

Both parties like big government the Democrats are just more honest about their intentions. Yet the fact remains that the largest growths in government in my lifetime took place under Republican Administraions.

 

[ZambucaLu]

Vote Now!

Heh, I voted. Did you see the comments? I had to get out of there

Hey though....81% to 19%. Woohoo!

Lu

 

[Russ_and_Mia2112]

Yeah and conservatives have been such leaders on personal freedom wanting to shrink government just to the size to fit in our bedrooms and tell us who how and when to have sex.

Seems to me that "just say no" came from that conservative icon Ronald Reagan's wife and I've not heard any prominent elected republican suggesting that we should decriminalize Cannibis.

Oh and then there is that whole gay marriage thing guess that's not a personal enough freedom to qualify.

Sure there are more than a few democrats who go too far in trying to protect people from their own irresponsible actions and generally I and not a small number of other liberals oppose them.

But to pretend for one second that the Republicans have ever been the champions of personal freedom is utter nonsense.

I am reminded of what Gore Vidal once said about American politics "We have one political party in America with 2 right wings"

Leftists have never been in power in the United States it's always been conservatives.

Now as a practical consideration in this case the Republican's in congress may be our temporary allies due mainly to the fact that their current political ideology seems to consist of nothing more than opposing anything the democrats propose. But this is no indication of their valueing personal freedom. The only freedom that elected Republicans have ever shown any support for has been the freedom for rich .......s and corporations to abuse us peons.

Both parties like big government the Democrats are just more honest about their intentions. Yet the fact remains that the largest growths in government in my lifetime took place under Republican Administraions.

Hey, I'm not going to argue about which party offers the greatest opportunity for individual freedom and liberty - I'm a Libertarian, the scourge of both of them. Sure, Republicans are just as bad...My point was that just because there is a Democrat in office - don't get your f'ing hopes up - because the precedent of intrusive, individual rights being squashed by the Democratic party is just as bad, perhaps even worse.

Speaking of gay marriage, interestingly enough - the current president, who is a current member of the Democratic party, along with his Vice-President - both are against gay marriage...You know that, right?

Regardless, I didn't mean to start a political diatribe. They are both scoundrels, they both encroach individual freedom and liberty at every opportunity that they can get away with, and neither party cares about the interest of e-smokers/vapers...Until we have a lobby as large and as powerful as the tobacco industry, the Insurance industry and the Pharmaceutical industry - who practically write the legislation that both Democrats and Republicans ultimately endorse.

 

[Vicks Vap-oh-Yeah]

Will this thread degenerate into a political mud-slinging vent? Take the rant outside...and I don't care WHO started it!

ON topic - Please!

 

[RacoonSpirit]

Isn't this going to be a hard arguement to win stated like this? I mean, take a good look at your PV - it's not made out of tobacco.....it's made out of steel, electronics, plastic, paint......no tobacco in their mfg at all.....only miniscule amts in the liquid.

I can understand the second part of the quote as clarifying the first, but still.....this could very well lump the device together with the liquid, instead of separating them.....

I would still like to see that happen - a definition for the gizmo (Chinese novelty item), and a definition for the liquid...

Hey Vicks, I think you hit a strong point here. When folks ask me about my e-cig, I refer to it as my personal vaporizer which has replaced my smoking habit. I steer away from associating it with analog cigarettes to avoid the negative connotation being associated with my device. I use the analogy of a miniature version of table top vaporizers like sold in Sears (or many other stores) just shrunk down to a more portable version. I make a clear distinction between the device (PV) and the juice, advising the juice comes in various levels of nicotine content, including 0 level, and that one can create there own 0 level juice by purchasing a gallon of propelyne glycol at Wal Mart for 25 dollars, and use any non-oil based and non-sugar based candy flavoring to flavor the juice.

The devise itself, IMHO, should be classified for what it is, a truly portable personal vaporizer. The nicotine in the juice, if anything, should be the only factor of controversy. I have only been vaping for about 2 months, but have weaned myself down to almost the lowest level of nicotine, often vaping a 0 level for many hours of the day. For me, the act of vaping has replaced the act of smoking. Nicotine is not so much the craving for me as is the psychological habit of puffing, inhaling, and exhaling a "cloud". Soon I will be using only 0 level juice and will not stop vaping - I enjoy the habit too much.

In my humble opinion, FDA should have no say in the legality of the device itself as it has no say in other personal vaporizers/humidifiers. It should be classified for what it is. The nicotine juice should also be left alone, since nicotine in tobacco is not considered a drug, why should the juice? As stated previously in this thread, many vegetable plants contain nicotine - why are they not controlled? And I do not believe the tobacco industry should be involved at all - this is NOT tobacco and should not be associated with all the negativity surrounding the use of tobacco.

I personally will be writing the involved parties and my local law makers explaining my experience and position. This device has allowed me to replace a 2 pack a day smoking habit with a habit that is hurting no one and I feel much healthier. I can taste food much better and run and play with my grandchildren much longer before getting winded (at that is improving daily). I personally enjoy the many flavors more than I ever did the tobacco.

I live in a land that is suppose to support personal freedom. I should be free to choose vaping over smoking - even if it does turn out to be more harmful than I believe it to be, common sense tells me it is much safer than analogs and it certainly is not posing any danger to those around me. A recent experience at work confirmed this to me. A colleague was around my for over 20 minutes and finally asked me what I was sucking on (a DSE901, black with blue LED). They were extrememly curios since it was glowing blue and producing no odor. Once I explained my PV, they eagerly asked me where they could get one. I advised them of the FDA fiasco and advised they visit this forum and get more information before purchasing. To classify these as illegal would be a crime against humanity! I would like to find an attorney that is looking to make a name for him/herself that would take a case like this pro bono - it certainly is an issue that is for the common good of the people.

Happy vaping to all and let us pray our Creator sees fit for these to remain in the hands of those that could use them most to save their lives!