Fda crackdown looms

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skex

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Lacey, that video is great, but that quote is not accurate and the FDA will shoot it down in a hurry. Those who choose to quit cigarettes have a plethora of FDA-approved nicotine delivery systems at their disposal, some over-the-counter, some prescription-only. I know, I know, they're not very effective, but we have NO STATS on how effective e-smoking is.

Did they have stats on Nocorette when it came out? How effective was it shown in clinical trials? What was tested? Because as a stop smoking aid these drugs are utter failures and if they are the yardstick against which the E-Cig is measured well it's hard to perform worse than abject failure.

The real question that the FDA has to answer is this. Nicotine is a known chemical that is already sold over the counter in a number of forms marketed both as a drug and as a recreational stimulant in a number of forms including inhaled. So on what grounds are they asserting authority?

They can of course assert anything they want but the legal question remains outstanding and will be determined in a court of law.

I suspect based on the judge hearing the SE case that they will be smacked down.

Honestly these devices have been around for what 3 years now in use world wide and to the best of my knowledge there has not been a single death attributed to their use. That's a pretty compelling stat for them to argue against.

See the thing to understand in science is that science doesn't prove anything ever. What it does is disproves things.

In the case of the E-Cig the theory is that it is safe for human use. This is supported by the fact that there are no documented cases of any health problems being caused and until such time as that theory is falsified by factual data.

This is not a cigarette-versus-ecig matter. It will not be framed that way by the only authority that counts, the FDA. It is about the e-cig only, and whatever evidence or lack of exists for its safety and efficacy.

The video plays well with common sense. If only we had facts to back up our assertions.

Of course the FDA isn't going to frame it any other way the trick is to beat them to the punch on framing the issue. To concentrate on facts like the lack of any documented deaths or health problems attributed to electronic cigarettes.

I think most judges are going to take a dim view on the FDA attempting to assert authority in this manner regarding this matter. Where is the compelling justification for a ban? Medical device? Seriously can anyone demonstrate where such a device is used anywhere for medicinal purposes?

Honestly the push back needs to be on those grounds. We have companies selling contaminated peanut butter to elementary schools , daycares and retirement centers resulting in real sickness and death because of insufficient oversite and the FDA is wasting time and energy trying to assert authority over a device that has shown zero evidence of presenting a health threat?

The only reason they've been as successful as they have been so far is that no one has been pushing back. Now with the SE lawsuit and the ECA getting off the ground the game has changed.

By the way the first rule of framing is never repeat the oppositions frame. These devices are simply a new way of imbibing an existing legal recreational stimulant and the FDA is overstepping its authority to try and ban them in the absense of any compelling health threat associated with their use.
 

silverfox

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maybe we should use the "green" argument...switching to e-cigs is kinda like switching to battery powered cars, less emissions...lol...

maybe we should come up with a hand-crank charger to further save on energy..lol...

in my opinion the FDA is on shaky ground already for stopping shipments without there being a ban in place beforehand...i hope the lawsuit against them is successfull because they are definitely guilty of causing monetary damages to small buisnesses in the U.S. already without the real (approved) authority to do it..
 

GratefulNerd

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The FDA is likely to site the one, single, solitary study that claims nicotine may be linked with cancer.

FOXM1 Upregulation Is an Early Event in Human Squamous Cell Carcinoma and it Is Enhanced by Nicotine during Malignant Transformation
I can't post links yet:
dx.plos.org/10.1371/journal.pone.0004849

Also here's a link with a more balanced view on the matter.
Does nicotine cause cancer?
healthline.com/blogs/smoking_cessation/2009/04/does-nicotine-cause-cancer.html

Also don't forget that violation/penalty fines serve as an unlimited source of revenue. (motive established)
 

Vicks Vap-oh-Yeah

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LaceyUnderall

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But - the link to cancer in these studies is if you HAVE cancer, this MIGHT accelerate the growth, yes? Nicotine doesn't cause cancer, it might help it along - but sugars do the same thing.

Exactly.

And the same issues arise with long term testing of the ecig. How many of us ex-tobacco smokers are positively sure that we do not have any cancer?

The only real test you could do to achieve real results is to test non-smokers... and that would mean converting non-smokers to smokers...

OR wait for a new generation of smokers who smoke only the ecig and are willing to attest to the fact that that is all they are going to ever smoke.

Studies are just studies and can be proven wrong... proven right... come out with a different outcome... they are the best evidence we have, but they are not 100% faultless.

As far as I am concerned, with all of the reading I have done, nicotine is no worse than caffeine and as it has been noted by the ECA, "Nicotine is guilty by association". Nicotine is not good for you, but neither is caffeine and both offer the same side effects. (One is sold to children and the other is not).
 

jcoppers

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If I may quote a couple of points in that article..."Screening putative carcinogens in human oral keratinocytes surprisingly showed that nicotine, which is not perceived to be a human carcinogen, directly induced FOXM1 mRNA, protein stabilisation and transcriptional activity at concentrations relevant to tobacco chewers." Also the following statement "We hypothesise"

Facts have not been stated yet, these are hypothesis at the time of this writing.
 

LaceyUnderall

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OH! And before I forget... there is a study going on currently in Cali regarding a nicotine lotion that diabetics can apply to rashes that could possibly lead to gangrene and then amputation. The idea is that nicotine would help boost cell growth.

And wouldn't you know I can't find the link in my bookmarks! Crap. I will find it and edit.
 

mmmvaping

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Interesting, If nicotine causes cancer to excell then tabacco which contains nicotine is in the same catigory as the e-cigarette. Those who chew get more nicotine at least twice as much. Because there is no cumbustion to lower the nicotine level. ONE cigarette before smoked contains at least 10mg of nicotine after cumbustion it may contain as much as 2mg deoending on how you smoke it. The FDA has no real ground evidence or a solid foundation to ban cigarettes. But they can still win. a few years ago the FDA were given the right over nicotine rights. But not over cigarettes. that makes absalutly no since....Cigarettes contain nicotine. So why dont they have the right over cigarettes? And why aren't they ban when they are known to kill. But the FDA argue that e-cigarettes may not be safe. But they have not one shed of proof. Makes no since. Is this what I pay taxes for.
 

yvilla

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And don't forget that that new hypothesis that nicotine may encourage growth of existing cancers applies equally to the many already FDA approved NRT products on the market.

One of the reports even has the researcher pointing out that he didn't advise people to stop using NRT products (on the basis of his new "findings"), on the grounds that they are clearly still better for people than smoking cigarettes!
 

TropicalBob

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Good points. Yvilla, if the FDA doesn't act, it won't be because of cold feet but cold facts. You've been an attorney. If you were advising the FDA, wouldn't you say:

"Ladies and gentlemen, you should not make statements about electronic cigarettes in the court of public opinion when you are now facing action in a court of law. Do not provide the cameras and scribblers of the press with arguments you will present later to a judge. Do not prejudice your case. Do not tip your hand. Do not attempt to influence opinion before the case against you is heard. There is no compelling reason to speak now, or to take action now. Say nothing more to anyone until you have the opportunity to make your case in court."

My hope here is that SE wins on the request for a temporary injunction, since the FDA action really does put them essentially out of business before their product has been ruled illegal. Then the court can move forward to define what e-smoking is and how, of even if, it should be regulated, and by what agency.
 
What I would really ultimately like to see is a compromise. There are some obvious reasons the FDA needs to get involved with e-cigs. However if there intentions are to ban it out right that would be devestating on so many levels. Basically people need to stop claims, in my mind it is not a product to help you quit nicotine (either is the gum or patch if you ask me though). Its an "alternative". Maybe we should leave the suppliers advertisement at that (tobacco smoking alternative) and let the doctors do the talking about about how much of a healthier alternative it is and not the suppliers (and yes, it is in my mind a SO MUCH healthier than puffing smoke but there are issues with saying that in the USA without FDA consent). A few things could be improved for overall safety such as a strength limit to juice. Right now if someone wants to they could make 64mg juice, that could do some damage both to our cause and to the person inhailing it. Also the bottles should have some warning (do not swallow, nicotine is addictive, etc). Probably they should all arrive in child proof jars with the option of purchasing dropper jars to transfer the liquid to. A few basic guidlines, could actually be better in the long run. If the FDA would just set some general guidlines to e-cigs and not step in and totally ban them than it could actually be better for us in the long run. I would love to go down to my local corner store and buy some e-juice and a new atomizer at a moments notice. However in all reality this probably will not happen (but lets keep our fingers crossed). To me though, it would be the most logical solution.
 
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hey guys im from the UK, so im not too educate don the whole FDA issue, but from what i gather, the FDA were supposed to give their results TODAY?!?! so is the product now banned or not?

no doubt that whatever the results are that Britain will follow suit, and ban the products. the only problem that the british authorities have is that the nictine liquid itself is toxic if ingested. but other then that i think the authorities have no problem with it.

im kind of nervous because i am in the process of launching my own ecig company in the UK, so if anybody has got any info on the FDA issue then please post :) ps great product and great forum. thanks :)
 

SavePaperVapor

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This is ridiculous. I've been eying e-cigs at my local smoke shop for weeks now. I really want to purchase one but whats the point if they will be banned any day now. So instead I'm dumping cancer into my body. And yes, they are still on the shelves today. I read in another thread that petro was pulling theirs today but every place in my town still has theirs available.
 
Hey SavePaperVapor,

Don't let that stop you from buying an e-cig. I just got mind yesterday and feel the same as you (just finding out about this, now there might be ban, etc). All I can say is if you buy an e-cig and maybe two bottles of 30ml liquid it will pay for itself in a month because you wont be smoking as much (or any) analogs. Worse case scenario you just get to at least expirence the e-cig for awhile, a better scenarrio is that you will still be able to buy liquid/parts for months or years. $6 a pack a day is $180 a month. A kit for $50 a couple of spare parts and e-liquid will introduce you to e-smoking for well over a month for much less a cost. Even if its only a month it does not hurt. If you buy cigs you are already throwing tons of money away!

As a side note, this whole discussion always makes me think of that movie "Who Killed The Electric Car".
 

Sun Vaporer

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Christmas has came and gone. Once again showing that the FDA will play this game their way.

The rumor mills on this forum are working in over drive. I am all for free expression but if I hear one more thing about company X pulling product :mad:


Vape on. Lets hope this stay of execution lasts.

Boston George--I am with you on this as I am a little skeptical about that e-mail but it did say the 6th if I am not mistaken so lets wait another day and see what the deal is. Either way I imagine the FDA will make its move---maybe the SE lawsuit took out their timetable till after they see if they defeat the requested TRO--so we will see--Sun
 

Vicks Vap-oh-Yeah

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Boston George--I am with you on this as I am a little skeptical about that e-mail but it did say the 6th if I am not mistaken so lets wait another day and see what the deal is. Either way I imagine the FDA will make its move---maybe the SE lawsuit took out their timetable till after they see if they defeat the requested TRO--so we will see--Sun


No, Sun, the original EM had a release date of the 5th.


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

Planned Release Date: May 5

Driving Event: Compliance action
 
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