Facts regarding the FDA Press Release - 7/22 (repost)

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TropicalBob

Vaping Master
ECF Veteran
Jan 13, 2008
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Prediction: It will not make news. Not like the FDA announcement did. Not even close. A pro e-cig test will not make NBC Nightly News, for instance. It might rate three paragraphs from the AP, if they even write about it.

The damage has been done.

And where was njoy, an American company, when tests were needed to get approval for their product? Can't say they didn't know how the system worked. They did. They just blew it. Tests courtesy of a maker now are too little, too late. I am very angry with them, as you might can tell ...
 

LaceyUnderall

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Dec 4, 2008
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And where was njoy, an American company, when tests were needed to get approval for their product?

Why on earth would they get approval of their product as an NRT when they do not have any intentions of providing it to the market as such?

This goes back to the argument of whether or not the FDA has the regulatory right to control a product that does not make any cessation claims or health claims? nJoy does not believe that their product is an NRT. They believe that their product is an alternative to tobacco cigarettes. Plain and simple. They have every right to argue that point based on the law that is currently in place.

You have every right to be mad. You see it one way and they see it another.
 

tikva

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May 3, 2009
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Posted in the Supplier's Forum from dekang:

"On 22 July 2009, FDA has issued an article concerning the safety of electronic cigarette cartridges and liquid. The most important issue raised was the presence of Diethylene Glycol, a toxic chemical used in anti-freeze.
http://latimesblogs.latimes.com/booster_shots/2009/07/fda-electronic-cigarettes-are-a-nono.html

We have so far received several emails concerning this issue from our customers, and we think it may be of concerns to other suppliers too.

Yunnan Changning Dekang Biotechnology here declares that our e-liquid does not contain Diethylene Glycol. E-liquid tested positive for this chemical by the US FDA is not produced by Dekang.


Dekang’s e-liquid and cartridges has been thoroughly tested and confirmed to be safe by SGS, Korean FDA and German TUV LFGB. In addition, the cartridges are made in the factory of our subsidy Boge Technology. The factory has received GMP, ISO9001[FONT=宋]:[/FONT]2008, ISO13485;2003 Canada CAMDCAS certificates.

Dekang will not hold responsibility for e-liquid that has been modified by traders/suppliers. All our original e-liquid comes in childproof bottles with YNDK logo imprinted on to the cap.

Certificates are available upon request. Please email frances@yndekang.com if you have questions regarding our liquid safety and certificates."




************************************************************************************************
 

lachesis

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Mar 30, 2009
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Jeez, this whole timing of e-cig bashing from antis, Waxman Bill, and now this lab result is forming a perfect storm. Not to be a conspiracy theorist, but it certainly is rather fishy.

Anyhow, I was rather surprised to see any carcinogens in e-liquid. It was exactly the reason I went for an e-cig.... and this thread has enlightned me that the level of carcinogens in e-liquid is not much higher / even less than NRT stuff.... It's good to know. :)
 

Computer Extreme

Unregistered Supplier
May 2, 2009
59
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esmoke4life.com
This is not a sales pitch, just something that I want to share.

I only smoke dekang juice. It costs a tiny bit more.

I have spoken with francis from Dekang at length.
She seems really like a great person.

She told me that they are working with the FDA to insure all is perfect.
Hence no more 36mg juice.
They are commited to being the most perfect e-juice company as they produce 90% of it for the world.

It surprises me that someone would change the juice they get from Dekang, because if you ask, they will make anything you want , any flavor!,so you dont have to deal with juice or fool with it at all.

So the 10% of the other e-juice out there is from?????
I havent been able to track that down.
I guess SE uses the latter?????

Who is the latter 10% and I want to know so as not to buy from them.

Tom
 
Thanks to grimmer255 and OutWest:

http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

This is the full report. It seems to be (upon preliminary examination) similar to the Health New Zealand study. I take it as actually encouraging (taking into account the amount of TSNAs in nicotine gum). A side-by-side analysis is probably needed here. Anyone up for it?

Worked on it all day.. and then realized I did not need scientific stats to write a news article cause the public is made up of mindless drones so I made it a sensationalitic piece (with references to make sure I had proof of my statements).

Some of the links I have are in this thread already.. will add any additional at bottom.

Re: age - if every supplier could do that, that would be fantastic!

Re: the chart - Looks like those values are in micrograms. The Health New Zealand figures are in nanograms. 1 microgram = 1000 nanograms. I'm a little confused as to how you arrived at 0.7684 micrograms for electronic cigarettes. Did you mean 7.684 nanograms? That's more in league with HNZ's findings.

Good stuff either way!

[EDIT] Carlos, see the footnotes of the first post.

Age stats from online suppliers not relevant. Will only be criticized because confirmation of age is "they fill in the date of birth online", not any physical identification. We need age stats from kiosk owners who ACTUALLY check ID's.. good luck with that lol!

Check with the OP, but if I rem right.. 7.684 ng is correct on that. Will see if I can find original study and post link at bottom. (edit:ref link is in OP!)

What about the argument: "The electronic cigarette has nothing to do with children. This product is marketed to an adult consumer base. It is the goal to offer consumers of smoking age an alternative to known killers, not to introduce new smokers to a new product." Then we can include some real statistics regarding consumer base.

I know I can pull my statistics of average age customer: 45 is the average age. I also can pull that not one person has ever purchased from me under the age of 18, and those in their 20's make up a very very small percentage.

I could ask other suppliers to pull their statistics as well.
Once again.. no verified age... age was self presented anonymusly online.

The key point is that the juice is derived from tobacco. The results show that a very high level of purity is achieved. Separating the nicotine and flavors from the not so nice stuff is not 100% perfect (nothing ever is) and a tiny amount of other tobacco constituents remains.

The 'detected' toxins are no higher than 1 part in a million, at most.

This report actually demonstrates just how very safe the juice is.
True! SE carts showed ND (non detectable) levels for the majority of TSNA's with the exception of the tobacco flavors, because as you have pointed out... the refinement process may be REALLY good.. but trace amounts may remain.

It needs comparing to the chemicals in a tobacco cig and to the chemicals in the air you breath standing on a city street during the rush hour.....that might put a little bit more perspective on it all.
Working on the analog comparison... but the city street one is tougher. Hard to find studies on "air on city street".. but I found one about nitrosamines in car exhaust (study was on a mechanics garage to determine safe working conditions). Was done by OSHA and so is a good study.. but 26 windows open and comp crashed so I lost a bunch of the good studies and can't find them again!! Ahhhh!!!!!! (sorry... minor freak out). If someone can find this would help.. OSHA follows FDA max acceptable quantities and so those stats would help.

OK.. scouring this damnedable report to figure out what they're trying to say about TSNAs, I *think* that they tested for each one at varied detectable levels. For instance, N-nitrosoanabasine (NAB) was detectable at 21 ppb. They are essentially saying that the Njoy cartridges had at least 141 parts per billion TSNAs. Oddly, the control in the tests (the Nicotrol inhaler) shows no results at all. According to the key, this means that the sample was not available for testing. There doesn't seem to be any explanation given for its absence.

So, according to this report, Njoy's cartridges contained at least 141Ng TSNAs, while Health New Zealand found 8Ng in 16mg nicotine solution from Ruyan. That's a huge disparity, especially taking into account that the Smoking Everywhere cartridges were found to contain anywhere from 0Ng to 99+Ng TSNAs. It's pretty obvious that the liquid from each company is different.

However, to maintain perspective, 1230 ppb TSNAs in unburned cigarette tobacco.

LOQ = limit-of-quantitation and I think means the amount needed to qualify as "detectable" (someone correct if I am wrong?) which essentially means we have no idea how many ppb were found of each type in each cart.. only that is was more than the LOQ. That makes ya kind of wonder why the measurements were omitted. Oh.. I know why.. nevermind. Anyone read bullet#4 on page 2 of the "study"? It says to detect or not detect they "estimated by simulating use temperatures". See.. they ESTIMATED. So they have no fuc.. oh sorry... wrong forum lol! no FREAKING idea what the actual numbers are (or they know the trace amounts in the few detectable are pathetic and scientists will laugh at them).

nicotrol inhaler (see page 6 bullet #2).. the extraction method is absent because they prob didn't test it yet (this is just a "preliminary study" lol! They have nerve to even call it a study. This is pathetic!!!!!)

Throwing in a small possibly irrelevant factoid: There's one of those "Injury Board" posts up today about this FDA release.
E-cigarette Anyone? | InjuryBoard West Palm Beach

Behind a link that appears as "e-cigarettes are available online and companies market those cigarettes to the young consumer" is a photo featuring Howard Stern, Danny Bonaduce and... someone else, apparently pulled from SmokingEverywhere's site though I don't see it there:
http://www.smokingeverywhere.com/images/Howard_stern.jpg
I honestly do not know if a lot of under-18s or under-21s listen to Stern and Bonaduce's shows.

And the usual arguments we make about children are (a) cost and (b) flavorings are present in alcohol but no one's talking about banning flavored alcohol because we must think of the children. Related to cost would be the impossibility of keeping all the related supplies/chargers/etc. hidden from parents; it is far easier to buy and conceal a pack of cigarettes.
Avg Stern demographic is also in 40's

We usually use the "hard to hide" with legislators also because it makes most sense and is least disputable. Also we explain we support age restriction on purchase and use of the device. Saying that right away means half as much work to argue our point.


Lol nitrosamines are also found in beer, meat, cheese, etc. :p
yup... but tobacco specific ones are not always comparable.

I need this asap. Please contact me if you have access to lab test results on Nicotine Gum and/or the Nicotine Transdermal Patch.
Go to Michael Siegels Blog. Read the comments. I asked him for a link to his ref's. He posted a link to one article that had the other ones on NicCQ and the gum listed as references at the bottom of the article. That was how I got that info.. but lost the articles when the comp crashed.

One more thing..

Why doesn't the ECA take all of the donated funds and use the money for an independent laboratory pitting the njoy ecig against a pack of Marlboros?

Why doesn't the FDA test Johnson Creek smoke juice? Aren't they in line to be FDA approved anyway? It's about the truth isn't it? I'm also beginning to suspect that the sudden changes in Johnson Creek smoke juice may have something to do with the quest for FDA approval and that perhaps they (Johnson Creek) found something they didn't like? Just guessing on this one, but the timing sure seems right enough to make it plausible?

Robbie

Ummm.. yeah... why don't they? Problem is ECA is composed of people with vested interest in the product. That makes any study they pay for just as unreliable as Ruyan's or the FDA's. Bias will always be present.

The JC issue occurred to me today in the midst of reading studies. What if their VG was from China and was really PEG and ended up having signif quantity of DEG? Hmmm... I smell somethin! Not FDA approval.. but dangerous situation being corrected maybe. I don't know.. I am on NO sleep.


Here's another table showing levels of Nitrosamines in new tobacco products:

http://www.starscientific.com/404/stepanov tsna in.pdf

All of the measurements are in micrograms, so multiply by 1000 to get nanograms (the standard we seem to be dealing with).

According to this study:

Nicoderm - 8 nanograms total
Nicorette - 2 nanograms total
Marb Red - 6300 nanograms total

I'm sure you can find others that vary in specifics, but show the same trend.

Oh! This may be the study that the snus chart came from? No.. nevermind.. I remember which one this is now.

Interesting point... all levels shown above here are based upon one "dose". One piece of gum, patch, cigarette. The levels in FDA study were based on a "cartridge" which we all KNOW is equal to about TWENTY cigarettes so that amount has to be divided by 20! (ok.. maybe by 5 or 6.. but still that changes the stats quite a bit!).

It is on it's way.

I can share this: The lab that did the testing is VERY reputable!

God I hope so. It really does not cost that much to do the kind of study the FDA did. Some schools (medical schools w/good chemlabs) can be convinced to do it for free with proper publicity!

I'm angry also.
last nights broadcast did more harm than good.
No it did not... Has anyone checked the number of new members here and at Vapers Forum since the story was made public? EVERY new vaper and ALL publicity.. helps our cause.. even bad. Now many of the news stations will try to make it a "controversy" by showing our side... we just have to put it out there. Show the deception.. but don't forget people... the HUMAN aspect (my mom died of lung cancer, my kid has asthma, my sister has bronchitis, my kids say I smell good now and are happy I won't die!) is where it's at! That sh** sells better than any amount of stats! (sorry... keep forgetting where I am).

Jeez, this whole timing of e-cig bashing from antis, Waxman Bill, and now this lab result is forming a perfect storm. Not to be a conspiracy theorist, but it certainly is rather fishy.

Anyhow, I was rather surprised to see any carcinogens in e-liquid. It was exactly the reason I went for an e-cig.... and this thread has enlightned me that the level of carcinogens in e-liquid is not much higher / even less than NRT stuff.... It's good to know. :)

yup.. I smell something...

We are having an article contest at VF and hope others will submit their articles to win prizes. It can be published online or in print, but must be somewhere other than a blog. Rules are in the thread. Wil edit this to add info as soon as I go pee :)

Too tired to go thru these... here's a few...

http://ntr.oxfordjournals.org/cgi/content/abstract/7/3/443

http://carcin.oxfordjournals.org/cg...d75db2f79ecb545ec18fd506&keytype2=tf_ipsecsha

http://cebp.aacrjournals.org/cgi/content/full/16/10/2170

http://www.ncbi.nlm.nih.gov/pubmed/8277523?dopt=Abstract

http://legacy.library.ucsf.edu/tid/ipc32e00/pdf;jsessionid=EBA5370255F3F38F7E2287B674D7452F
 
Last edited:

Krakkan

Unregistered Supplier
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Feb 22, 2009
855
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www.truesmoker.com
Worked on it all day.. and then realized I did not need scientific stats to write a news article cause the public is made up of mindless drones so I made it a sensationalitic piece (with references to make sure I had proof of my statements).

Some of the links I have are in this thread already.. will add any additional at bottom.



Age stats from online suppliers not relevant. Will only be criticized because confirmation of age is "they fill in the date of birth online", not any physical identification. We need age stats from kiosk owners who ACTUALLY check ID's.. good luck with that lol!

Check with the OP, but if I rem right.. 7.684 ng is correct on that. Will see if I can find original study and post link at bottom. (edit:ref link is in OP!)


Once again.. no verified age... age was self presented anonymusly online.


True! SE carts showed ND (non detectable) levels for the majority of TSNA's with the exception of the tobacco flavors, because as you have pointed out... the refinement process may be REALLY good.. but trace amounts may remain.


Working on the analog comparison... but the city street one is tougher. Hard to find studies on "air on city street".. but I found one about nitrosamines in car exhaust (study was on a mechanics garage to determine safe working conditions). Was done by OSHA and so is a good study.. but 26 windows open and comp crashed so I lost a bunch of the good studies and can't find them again!! Ahhhh!!!!!! (sorry... minor freak out). If someone can find this would help.. OSHA follows FDA max acceptable quantities and so those stats would help.



LOQ = limit-of-quantitation and I think means the amount needed to qualify as "detectable" (someone correct if I am wrong?) which essentially means we have no idea how many ppb were found of each type in each cart.. only that is was more than the LOQ. That makes ya kind of wonder why the measurements were omitted. Oh.. I know why.. nevermind. Anyone read bullet#4 on page 2 of the "study"? It says to detect or not detect they "estimated by simulating use temperatures". See.. they ESTIMATED. So they have no fuc.. oh sorry... wrong forum lol! no FREAKING idea what the actual numbers are (or they know the trace amounts in the few detectable are pathetic and scientists will laugh at them).

nicotrol inhaler (see page 6 bullet #2).. the extraction method is absent because they prob didn't test it yet (this is just a "preliminary study" lol! They have nerve to even call it a study. This is pathetic!!!!!)


Avg Stern demographic is also in 40's

We usually use the "hard to hide" with legislators also because it makes most sense and is least disputable. Also we explain we support age restriction on purchase and use of the device. Saying that right away means half as much work to argue our point.



yup... but tobacco specific ones are not always comparable.


Go to Michael Siegels Blog. Read the comments. I asked him for a link to his ref's. He posted a link to one article that had the other ones on NicCQ and the gum listed as references at the bottom of the article. That was how I got that info.. but lost the articles when the comp crashed.



Ummm.. yeah... why don't they? Problem is ECA is composed of people with vested interest in the product. That makes any study they pay for just as unreliable as Ruyan's or the FDA's. Bias will always be present.

The JC issue occurred to me today in the midst of reading studies. What if their VG was from China and was really PEG and ended up having signif quantity of DEG? Hmmm... I smell somethin! Not FDA approval.. but dangerous situation being corrected maybe. I don't know.. I am on NO sleep.




Oh! This may be the study that the snus chart came from? No.. nevermind.. I remember which one this is now.

Interesting point... all levels shown above here are based upon one "dose". One piece of gum, patch, cigarette. The levels in FDA study were based on a "cartridge" which we all KNOW is equal to about TWENTY cigarettes so that amount has to be divided by 20! (ok.. maybe by 5 or 6.. but still that changes the stats quite a bit!).



God I hope so. It really does not cost that much to do the kind of study the FDA did. Some schools (medical schools w/good chemlabs) can be convinced to do it for free with proper publicity!


No it did not... Has anyone checked the number of new members here and at Vapers Forum since the story was made public? EVERY new vaper and ALL publicity.. helps our cause.. even bad. Now many of the news stations will try to make it a "controversy" by showing our side... we just have to put it out there. Show the deception.. but don't forget people... the HUMAN aspect (my mom died of lung cancer, my kid has asthma, my sister has bronchitis, my kids say I smell good now and are happy I won't die!) is where it's at! That sh** sells better than any amount of stats! (sorry... keep forgetting where I am).



yup.. I smell something...

We are having an article contest at VF and hope others will submit their articles to win prizes. It can be published online or in print, but must be somewhere other than a blog. Rules are in the thread. Wil edit this to add info as soon as I go pee :)

Spikey I will put up a Dragon kit for the contest as well --- common writers we need some stuff so we can shoot out our own press releases to every media station --- A confernce call with the MEDIA like the FDA did would be incredible if we could gather people like Siegel/godshall etc and present our findings / facts :)
 
Spikey I will put up a Dragon kit for the contest as well --- common writers we need some stuff so we can shoot out our own press releases to every media station --- A confernce call with the MEDIA like the FDA did would be incredible if we could gather people like Siegel/godshall etc and present our findings / facts :)
Thanks Krakkan! You rock!
 

AnglVapin

Super Member
ECF Veteran
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Mar 16, 2009
739
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Article for tomorrows online newsday local section... please proofread and offer suggestions (before morning!)

Is the FDA Really Willing to Kill Millions of Americans?
Collaboration by: Long Island Vapers Club
Long Island, New York - Vapers Club


Is it possible the FDA is really willing to risk the lives of millions of American citizens to protect Big Tobacco interests in America? Approximately 400,000 Americans die every year from illnesses related to smoking tobacco. These are illnesses that can be avoided by many if they have access to tools that would be effective in reducing or eliminating cigarettes from their lives.

One alternative to combustible tobacco cigarettes is a device known as an electronic cigarette. Despite the possibility that this device may save thousands of American lives, the FDA has initiated a logic defying campaign, which could block e-cigarettes from being sold in the United States. The most recent missile launched by the FDA is a 'preliminary report' evaluating electronic cigarettes. In this report, they warn that they have discovered carcinogens and toxins in the liquid contained in two brands of electronic cigarettes. The liquid is the consumable portion of the electronic cigarette. What they fail to provide is any specific information regarding quantity of the potentially hazardous substances they have found.

Simply stating that they found detectable amounts is not significant. There are trace amounts of carcinogens in plenty of foods we eat every day. Are the carcinogens they found in the vapor from e-cigarettes trace elements or a legitimate hazard based on previous standards set by the FDA? They even freely admit that the detection of these carcinogens was “estimated by simulating use temperatures”. They used a device to simulate the actual use of the vaporizer rather than testing on a human subject even though there are tens of thousands of individuals in the US voluntarily utilizing the product. Two of the three carcinogens found in electronic cigarettes are also shown to be present in FDA approved smoking cessation products that are currently on the market. (Can you actually name those products? Why not shock the crap out of the users AND MAKERS of those products and get them ticked at the FDA as well? I think it would rasie the eyebrows of many to see the names of the products that the FDA is not being totally honest about. JMO ) The levels of these carcinogens were conveniently omitted from the 'preliminary report'.

Another interesting coincidence is that the FDA is being sued, by the companies whose products were tested in the "preliminary study", for unjust confiscation of hundreds of these devices because the plaintiffs claimed that the FDA lacked jurisdiction over this product. The FDA, just a few days ago, finished arguing in court that electronic cigarettes are absolutely not tobacco products and only a couple days after the court stopped accepting evidence in the case, on July 22nd, they released this “preliminary report” (which was completed in May 2009) stating they found “tobacco” specific carcinogens (TSNA’s) in electronic cigarettes.The FDA is playing both sides of the argument. Until recently, the FDA had no jurisdiction over tobacco and they claimed electronic cigarettes were not tobacco products and that gave them the right to oversee these “drug delivery” devices. Now, mere weeks after they gained jurisdiction over tobacco, they declare these devices contain carcinogens specific to tobacco (which they knew in May as they argued that these were not tobacco products) and therefore they should be given control over these products.

Many anti-smoking doctors and tobacco harm-reduction specialists stand by and support the use of electronic cigarettes as a viable alternative to smoking tobacco, however none of these doctors were invited to speak at the FDA conference regarding these devices. A previous study on electronic cigarette vapor, which showed evidence of insignificant levels of TSNA’s, was not referenced in the FDA study. There are already many studies on the significant reduction in the number of TSNA's in any form of tobacco where combustion does not occur. None of these studies were cited either.

The FDA expresses concern for the children who may be able to afford to spend $100 on the personal vaporizer and the upkeep on this device. They feel these children could be enticed to try the devices by the cherry and fruit flavors; yet the FDA approved nicotine gum used to quit smoking, which comes in both of these flavors. Recently the FDA approved nicotine lozenges (sucking candy), which are available in cinnamon and cherry. Wouldn’t gum and candy be more appealing to children than a $100 temperamental device that would be exceptionally difficult to hide from a parent? Most of these devices are purchased online and in order to make a purchase online, one must use a credit card, and thus be 18 years old. Regardless of any of these facts, no one is arguing that there shouldn’t be an age restriction put on those permitted to purchase this device.

In the mean time, the fate of millions of American smokers is held hostage. No matter what the FDA wants to claim, the reality is that cigarettes are proven killers. While electronic cigarettes were found to contain what might be trace amounts of 3 carcinogens, which are already found in cigarettes, smokeless tobacco and some Nicotine Replacement Therapies, tobacco cigarettes contain dozens of known carcinogens and toxins proven to kill hundreds of thousands of smokers each year. No one is arguing that this is a 100% proven safe alternative, only that it is quite obviously a safer alternative to smoking. There has not been one single statement by the FDA which would dispute that these devices are less dangerous than smoking traditional tobacco cigarettes, yet those remain freely available to anyone of legal age to purchase them while the FDA wants to ban electronic cigarettes. It makes you wonder who the FDA is really protecting… doesn’t it?

Excellent!
 

Sar

Super Member
ECF Veteran
Mar 27, 2009
534
7
New York, NY
Article for tomorrows online newsday local section... please proofread and offer suggestions (before morning!)

Is the FDA Really Willing to Kill Millions of Americans?
Collaboration by: Long Island Vapers Club
Long Island, New York - Vapers Club

Is it possible the FDA is really willing to risk the lives of millions of American citizens to protect Big Tobacco interests in America? Approximately 400,000 Americans die every year from illnesses related to smoking tobacco. These are illnesses that can be avoided by many if they have access to tools that would be effective in reducing or eliminating cigarettes from their lives.
...

This is beautiful!!!

Should be actually posted on ECA homepage.
 
Uh oh...we better watch out! Our e-cigarette cartridges filled with less than a gram of liquid contain a barely detectable amount of a chemical that is 8 times more poisonous than water! Somebody who drinks just 2.5 Liters of e-juice has a 50% chance of death!

No wonder the FDA wants to regulate these things! What with all the people that are dying every day from drinking 2500ml of e-juice....wait a tic!...aren't they dying from heart attacks from injesting thousands of mg of nicotine long before they approach the LD50?? Well, at least the FDA approved NRT's are only slightly more toxic than e-cigarettes.

/sarcasm
 

bitey

Super Member
ECF Veteran
Verified Member
Mar 18, 2009
509
483
Central Ohio
Do you think that using product names could get me in trouble? Maybe if I quite the study and put a reference it woud not be as bad?

You wouldn't be in legal trouble per se because you aren't saying anything that is factually incorrect, although you could still be sued and have to spend thousands defending yourself. However, I think the use of the names would get the makers mad at us, not the FDA. Pharmaceutical makers in the US have been in bed with the FDA for years. After all, there are billions of dollars to be made every year. The same is true now for Phillip Morris and the FDA.
 
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