FDA Sued Over Electronic Cigarette Embargo

[Caesarea]

Obviously flavored nic liquids will be finished if the bill goes through.

The 'Zig'
contains the tobacco solution and aroma equivalent to one regular cigarette.
SFI offers a variety of aromas.
__________________

Smokefree Innotec offers a variety of aromas and strengths to the considerate smoker

The Components

Varieties



Note the words "tobacco solution".


So Iken, Walrus, it offers a variety of aromas and strengths to the considerate smoker

So it is back to the future with

Regular vs Light

Natural vs Menthol

but with the addition of Scented.

The future is strangely like the past.
Bland and scented like bathroom deodorant.

No fruits, no sweets, no chocolate, no coffee,

no food flavours at all.


Just bathroom cleanser flavours.

No food flavours = no temptation for little kiddies.

For the considerate smoker,
The future is strangely like the past.
Bland and scented like bathroom deodorant.
Why?

Because, see the website front page mission statements:-

"Breaking new ground and implementing new technology
are the defining motivations of our activities.
It all starts with an idea and ends with a product ready for the marketplace.
Center and focus of our thinking is the human being as a social issue:"





Ah yes, seen that before at Birkenau and Bergen Belsen.

C

 

[Rebel]

Interesting.

 

[esmok-e]

Just bathroom cleanser flavours....
Center and focus of our thinking is the human being as a social issue:"
Ah yes, seen that before at Birkenau and Bergen Belsen.

C

Instead of Zyklon-B, the FDA allows cigarettes to kill 1170 people a day. They should be "gassing" all enclosed spaces in Mexico (and planes, subways, buses, schools, etc.,) with 1 part PG to 2,000,000 parts of air instead of ramping up production and $upplies of Tamiflu!

 

[SanDeggo]

I don't want my DSE901 to even be considered in the same sentence as a cigarette. It is a personal vaporizer and as a group, we really need to stop using the words such as "e-cigarette" and "smoking". Because none of what we use our Personal Vaporizers for are EITHER of those. This is what is getting us in trouble in the first place with the FDA. I'm really not comfortable with Smoking Everywhere representing us, Sun Vapor should be.

I am curious to see results of the tests from the FDA. I of course have always been curious about the safety of the chemicals in the eJuice. I just hate how much that could limit us as eJuice users.

But non-the-less. I really don't know what this is going to do to our devices and juice. It seems as though the FDA is picking on a large supplier of the products we desire. And the only reason they are being sued is because it is tying up Smoking Everywhere's money. I hate that the FDA is being sued for that reason and that is what may determine the ultimate fate of our devices.

-Brian

 

[SanDeggo]

Instead of Zyklon-B, the FDA allows cigarettes to kill 1170 people a day. They should be "gassing" all enclosed spaces in Mexico (and planes, subways, buses, schools, etc.,) with 1 part PG to 2,000,000 parts of air instead of ramping up production and $upplies of Tamiflu!

The FDA has nothing to do with tobacco cigarettes. They are trying to get their hands on them, but the tobacco industry has always been overly protected by our government. So it's really not the FDA that lets 1170 people die a day, it's our government, from the top-down. There is no such thing as a FDA label on a pack of cigarettes.

 

[LaceyUnderall]

This is what is getting us in trouble in the first place with the FDA.

What is getting us into trouble are those suppliers who wish to market these as smoking cessation devices, healthier alternatives, etc. The FDA has clear jurisdiction over such claims, regardless of what the product has in it. If you bottled water and said that it was the "healthier" alternative to caffeine soda, you would have to have clinical tests proving it to be such.

 

[Iken]

The 'Zig'
contains the tobacco solution and aroma equivalent to one regular cigarette.
SFI offers a variety of aromas.
__________________

Smokefree Innotec offers a variety of aromas and strengths to the considerate smoker

The Components

Varieties



Note the words "tobacco solution".


So Iken, Walrus, it offers a variety of aromas and strengths to the considerate smoker

So it is back to the future with

Regular vs Light

Natural vs Menthol

but with the addition of Scented.

The future is strangely like the past.
Bland and scented like bathroom deodorant.

No fruits, no sweets, no chocolate, no coffee,

no food flavours at all.


Just bathroom cleanser flavours.

No food flavours = no temptation for little kiddies.

For the considerate smoker,
The future is strangely like the past.
Bland and scented like bathroom deodorant.
Why?

Because, see the website front page mission statements:-

"Breaking new ground and implementing new technology
are the defining motivations of our activities.
It all starts with an idea and ends with a product ready for the marketplace.
Center and focus of our thinking is the human being as a social issue:"





Ah yes, seen that before at Birkenau and Bergen Belsen.

C

Omg probally tastes like another component of a bathroom. Yes lets totally contaminate ourselves with this stuff to benefit the community with relaxing and soothing odors and the great thing is We won't be judged or discriminated against at all! We shall all be socially accepted lol
Uh Oh I see chinese writing on there! and it's not by PM!! No no no this will not due screams the FDA pocket. If I can direct your attention to flavorings if this is the case Eliquid Flavoring
pg and vg based no nicotine, Throat hit included
Wait, Caesarea You were being facetious right???

 

[skex]

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.

You do have a point on getting hopes up if no other reason that even if Obama had the political will and personal desire to line item veto the fact is that he doesn't have the power.

Also he's no where near the leftist that many on the right pretend. He's a very centrist democrat when it comes to actual policy. So his position on Gay Marriage which I view as mostly pragmatic cynicism, and his most likely position on the Waxman bill are not all that surprising.

Still you're are right that it doesn't serve our cause to turn this into an ideological argument.

My main thought is that from a practical standpoint we can pretty much count on Republican support for vaping just as their standard anti-democrat stance. However they do not have the power to actually stop the Waxman bill on their own as such it is not productive to demonize all Democrats when elected Democrats represent the best chance to snuff this legislation out.

Democrats are in general movable on issues and I think Waxman's intention with his bill is noble he's just ignoring some of the unintended consequences involved in this regulation further he's got in cahoots with some real monsters to get this deal through and seems to have forgotten a certain saying about laying with dogs.

The political reality on the ground is that to stop this mess we need elected democrats and to get them we need support from voting democrats and such people like myself are very suspicious of right wing rhetoric and framing.

Remember the Democratic party is not monolithic there is a reason why we had a long and contentious primary last year. The left wing of the party is trying to take it back from the Authoritarians. That's why we have President Obama instead of the DLC backed Clinton even though there is barely any daylight between them on most policy questions.

Anyway my point is that the political landscape is what it is and that's what we have to work with in. And rattling off right-wing rhetorical talking points (even if they're stolen talking points) and even if you really believe them (being a libertarian and all as you claim) is going to elicit certian emotional responses that shut down the recipeints openess towards your argument.

Liberals happen to think rather highly of individual rights as well. We value the constitution and the bill of rights just as much as anyone else.

Like I said the Democratic party is not monolithic at all. Will Rogers once said "Democrats don't agree on everything that's why they're Democrats if they agreed on everything they'd be Republicans" There is more than a little truth to that.

We don't have to swing many. Convince Bernie Sanders and a couple of the more leftist Democrats that this bill is a give away to Phillip Morris that will cause more harm than good and they join in opposition to the bill and it's effectively flatllined. Add to that a couple of centrist Dems from Tobacco states and you've got a nice diverse bipartisan resistence to that bill. Which will lead to either it's outright failure or ammendments to make it less horrible.

But you come arguing that Democrats don't value personal freedom and those people are going to tune you out.

 

[Caesarea]

Omg probally tastes like another component of a bathroom. Yes lets totally contaminate ourselves with this stuff to benefit the community with relaxing and soothing odors and the great thing is We won't be judged or discriminated against at all! We shall all be socially accepted

Can imagine the boardroom blue sky thinking -
Big Boss: "Wonderful, Jekyll, so we can make the smokers smell any way we want?? They can inhale and expel any aroma at all???"
Dr: "Yep, I reckon so..."
Big Boss: "If they inhaled Shake and Vac, we could make the cleaning lady redundant and save on air fresheners. Hey neat! "
Dr:"And anyway, sir, the aroma will mask any ongoing body odours caused by the PG affecting the individual Human Social Issue.In that way, no-one will be inconvenienced by working alongside the HSI units."
Big Boss: "Good thinking Doc!"
Dr: "With only a slight modification, we could also do without purchasing Harpic and Toilet Duck..."
Big Boss: "Make it so, Jekyll, make it so...."
Dr:"We have had enquiries also from paint-spraying and crop-spraying firms. Public Health are keen to know about informal fumigation of international airport lounges via HSI deployment..."
Big Boss: " Green shoots Jekyll. Excellent! Isn't it wonderful how much a few social issues can end up contributing to a better, cleaner society, Jekyll?"
C.

 

[gr8dane]

Tried posting this comment earlier, but got kicked out...so if it double posts, sorry.

As has been mentioned by several others, it would simplify things greatly if the manufacturers would quit including prefilled carts in the startup kits. That would completely decouple the hardware from the liquid, putting them in 2 separate categories to be 'controlled' (or not) independently. I'm not naive enough to think that this will necessarily fix the problem, but it should strengthen legal arguments to migrate the hardware out of FDA's radar range. So, the question is, how do we strongly suggest to the manufacturers that they modify their kit contents? It should be an easy sell. It will slightly drop their cost, and if they replace the prefills with blanks, they don't even have to change their packaging. So the transition could occur basically overnite.

BTW, if this were to take place, SE's battle becomes their own...if they want to continue handling prefilled kits, that makes their thing an entirely different hybrid beast from the 2 'mainstream' categories (hardware and liquid)...probably falling into the liquid control methodology, so they'd have to tackle that demon themselves. JMO
-Kathy

 

[Vicks Vap-oh-Yeah]

As has been mentioned by several others, it would simplify things greatly if the manufacturers would quit including prefilled carts in the startup kits. That would completely decouple the hardware from the liquid, putting them in 2 separate categories to be 'controlled' (or not) independently. I'm not naive enough to think that this will necessarily fix the problem, but it should strengthen legal arguments to migrate the hardware out of FDA's radar range. So, the question is, how do we strongly suggest to the manufacturers that they modify their kit contents? It should be an easy sell. It will slightly drop their cost, and if they replace the prefills with blanks, they don't even have to change their packaging. So the transition could occur basically overnite.

Great idea - and one that should have been implemented a long time ago....Unfortunately, the time for that idea has come and gone....

The FDA has the ECig on their radar in totality - the unit AND the liquid....in their eyes, they are NOT separatable - they are drug delivery devices and have NOT been evaluated, now pacify us with (insert $$ amt here)

With SE pushing their case to release the embargo, they're making it worse.....they're continuing to put the gizmo and the liquid together, thus cementing the two together in the FDA's eyes.

SE's going to either be the death of us all, or the proxy that gets thrown to the wolves to "set an example."

 

[TropicalBob]

Vicks is right that the time for corrective action has passed. Decisions have already been made. The FDA will hold its press conference next Tuesday, publicly answering the New Jersey senator's request to ban e-cigs. No rebranding, repackaging or repurposing will work now.

After that enforcement announcement and future policy, the suit must be adjudicated and the Waxman bill must make its way through the Senate. Then we can know End Game has been reached. It ain't over yet, but the Fat Lady is walking to the microphone right now ...

 

[Jim Davis]

Vicks is right that the time for corrective action has passed. Decisions have already been made. The FDA will hold its press conference next Tuesday, publicly answering the New Jersey senator's request to ban e-cigs. No rebranding, repackaging or repurposing will work now.

After that enforcement announcement and future policy, the suit must be adjudicated and the Waxman bill must make its way through the Senate. Then we can know End Game has been reached. It ain't over yet, but the Fat Lady is walking to the microphone right now ...

Do you know who will be covering this. I'll be of of town, and I want to see what is said.

 

[westcoast2]

Can the Judge order a "Finding of Facts" hearing?

 

[Caesarea]

Can the Judge order a "Finding of Facts" hearing?

Sounds like the French Examining Magistrate's role - do you have that in the US?

C.

 

[ericg772]

I called Sen Lautenbergs office and told his telephone representative I can not get my deliveries from china sitting in the Port of Miami even though calls to FDA and Customs offices told me they had never heard of E Cigs. Then with one phone call I found supply I could order overnight from NJ, Sen Lautenbergs own state. So suppliers in Sen Lautenbergs state are getting their deliveries and other states cant. The phone representative told me Sen Lautenberg doesnt represent me and to take it up with my Florida Senators and hung up on me. Doesnt every US Senate Senator represent all Americans? Only State senate Senators can say that. If Sen Lautenberg doesnt represent me as an American Citizen and Disabled US Paratrooper veteran (BS, PH) why can he stop my delivery from China??? Anybody have any suggestions on what we can do?

 

[techtravis]

Emails are commonly sent to the sender to bounce off to the other recipients to hide who they are. That way all replies go to her and no one else.

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

 

[delhameattree]

I think it's necessary to "pull" away from certain aspects of the "e-cig" as such. As a 2+/day-a-pack smoker for 20 years, I feel I have enough experience to say this and stand by my words. I refuse to accept ANY judgement by the FDA. They can't act their way out of a moldy bag of peanuts or a salmonella-laced bag of pet food from China, why would any reasonable person (i.e. federal judge) allow this to continue in light of that and a little device the FDA already approved called the Nicatrol Inhalor? Anyone remember that? I was forced to use it during a hospital stay, on top of a nicotine patch. It totally sucked. If I'm not mistaken, the FDA already has all the footwork it needs in place to not only approve e-cigs, but also make them safe. It would seem to me that based on the Nicatrol device, the pharmacological evidence is in place as a presc
ident and the SE suit is irrelevant other than freeing up shipments in FDA-lock down. I kid you not, the Nicatrol Inhalor was very much the same except there wasn't a battery. Anyone have any input??? I had thought of this a while back and yesterday I received my first e-cig. Right away the taste and feel of the draw was the same as the NI, until I got the hang of it and then it was totally different - like smoking a real cigarette. The NI sucked. It was very astringent feeling; my throat tightened and I actually recall feeling worse as far as coughing, scratchy throat, etc., plus it didn't address ANY psychological part of my cigarette addiction. Look, I know for a fact based on taste and throat hit, that the Nicatrol Inhalor was the prototype and the "e-cig" is the new and improved version. The FDA doesn't need to do didley to approve these. They maybe want to check out what the carts are made of, then again, maybe they should have checked what cigarette filters are made out of some 60 or 70 years ago. 4000 chemicals and how many years later, and now they are worried about e-cigs? Seriously?? The FDA SHOULD HAVE been worried about tabacco cigarettes a long, long time ago. They missed the boat, and therefore I think the argument can rightly be made that they are SOL.

 

[delhameattree]

BTW. by "pull away", I mean only that I refuse to publically refer to this as anything other than a Nicotine Replacement Device. In less than 24 hours out of the box, I'm down to 1 pack vs. 2 - 2 1/2, tha't friggen' impressive, if you ask me. In fact that is the most impressive result I've ever had in regards to any smoking cessation program EVER. I truely believe we must not support SE. Their lawsuit is about money and liquidating the assessts the FDA are currently holding and is of no real benefit, period.

Also, if I'd like to add that any comments of the "cutesy" kind - like popping your "vape cherry" or pot/drug references are hurting, not helping the cause. I've been to 40+ Dead shows, so I'm not being judgmental, I'm merely just sayin'......

 

[TropicalBob]

Del, please read around the forum before posting comments made many, many times before -- and refuted the same number of times. Suffice it to say the FDA does not and never has had power over tobacco products. The FDA has power to approve and regulate drugs. Your Nicotrol inhaler underwent clinical trials and was approved by the FDA. No e-cig has trials complete and no approval has been given for this new cocktail of drugs you and we are all inhaling. Those are the issues. The only issues.

I assume you mean well, but your points are not well-taken. And denigrating the FDA will get all of us nowhere.