Wednesday, July 22, 2009

Finally! FDA Questions Safety, Quality of Electronic Cigarettes


As reported first in the WSJ Health Blog, the FDA is finally looking into electronic cigarettes, and they don't like what they see. Here is the FDA press release and here is the full report.


I have previously posted on my concerns about the safety of e-cigarettes. These posts are some of my more popular ones, with so many readers not understanding my concern. Their points are that e-cigarettes are at least better than tobacco cigarettes, and nicotine itself is safe, since it is sold over the counter. However, the FDA seems to validate my concerns. Here's what they found.



  • In testing 19 products from two manufacturers, investigators found that the majority tested positive for tobacco impurities thought to be harmful to humans.

  • In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans

  • Half of the samples appeared to contain known carcinogens

  • Some products testing positive for nicotine even though the label said no nicotine was present.

The FDA is also concerned about the appeal of e-cigarettes and the easy availability to children:


These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or
conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people

Thus, I stand by the statements in my previous posts. Electronic cigarettes are not safe and should not be used to replace tobacco products, nor as a substitute for smoking cessation agents.

12 comments:

BMI Measuring Obesity said...

They can't be any worse than regular cigarettes.

Doug said...

My brother has schizophrenia. He smokes. A lot. We have tried convincing him to stop smoking, but it is impossible. As noted in this review of the literature on schizophrenia and smoking (http://psychservices.psychiatryonline.org/cgi/content/full/50/10/1346) people with schizophrenia are more likely to smoke and less likely to quit, smoking relieves some of their symptoms, and when they run out "some may resort to stealing, begging, prostitution, intimidation, and similar behaviors to obtain more." There is also evidence that when smoking is outright banned in psychiatric wards, 20-25% of the patients experience major disruptions in their treatment.

My brother has delusions regarding smoking and cancer that I won't go into, but I can't reason with him that smoking is bad for him and is causing his coughing problems any more than I can convince him that any of his other delusions are not real--and this is when he is compliant with his meds, and not experiencing a more complete break with reality.

My brother is living at home and regularly takes his meds, but we are not able to convince him to stop smoking, even after trying prescription smoking cessation products, with his psychiatrist's supervision. His heavy smoking causes him respiratory problems, and will almost certainly cause him lung cancer and or emphysema, and eventually death.

So the question is, what is the better path between watching him continue to smoke, or giving him the choice of the e-cigarrettes, which might at least lessen the amount of carcinogens he smokes and alleviate his respiratory symptoms? It seems to me that even a product of unkown safety is better than a product known with 100% certainty to be deadly. Especially when deductive reasoning and anecdotal evidence (both of which are not 100% evidence, obviously, but are all we can rely on in the absence of formal studies) indicates an e-cigarrette is likely to be much less harmful than regular cigarrettes--even the study you cite here does not indicate that the trace carcinogens in e-cigaretes come anywhere close to the amount of carcinogens in regular cigarettes.

Anyway, I would be interested to hear your thoughts on this.

Doug said...

"majority tested positive for tobacco impurities thought to be harmful to humans."

As opposed to 100% of regular cigarettes that contain tobacco impurities known to be harmful to humans.

"In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans"

Again, one sample in one out of 19 products, compared to 100% of all regular cigarettes which have numerous toxic chemicals.

"Half of the samples appeared to contain known carcinogens"

As opposed to 100% of regular cigarettes which contain known carcinogens.

Doesn't this really show that e-cigarettes, while dangerous, are not nearly as dangerous as regular cigarettes?

I agree with you that you absolutely should not smoke, under any circumstances, ever. However, if a person is going to smoke regardless of the health impacts (and many people clearly are), wouldn't that person be clearly better off smoking e-cigarettes that regular cigarettes?

Dr. Matthew Mintz said...

My main points are 1)before these products are consumed by humans, they should be tested and proven safe. They are probably safer then tobacco cigarettes, but I would like the FDA to confirm this. 2) e-cigarettes may safer than cigarettes, but regular nicotine consumption is still not healthy. 3) these are being promoted as smoking cessation aids and they have not been proven to help people quit. In fact, they may make it harder.

Doug, your brother's situation is a tough one. It is almost impossible to get schizophrenics to quit. THere is clearly something about nicotine that helps with their disease. Drug companies are looking at nicotine as a potential therapy for schizophrenia. The e-cigarette might be a good option for him since it is extremely unlikely he will ever get off cigarettes, e-cigarettes are probably safer than tobacco cigarettes, and nicotine might be treating his disease.

Doug said...

Well, as to number 1, I would also like to see some formal studies done on these. Unfortunately, the way things are structured it seems like formal studies are almost never done unless there is a patentable drug that makes it worthwhile for a big drug company to pay for the study knowing that it can get monopoly pricing if the drug is approved. It seems like any potential drugs that aren't patentable (and I don't believe e-cigarettes would qualify for a patent since they are already widely known) just never get studied, no matter how much evidence there is that they might be useful.

I won't argue with number 2 or 3. These probably aren't helpful for those who are trying to quit, but are at best an somewhat less harmful substitute for those who can't or won't quit no matter what.

Dr.Agasi said...

Puffing away at the cigarette is always a pleasurable experience for all smoking addicts and the feeling of well-being provided by nicotine makes the users of cigarettes and other tobacco containing substances consistently addicted to the habit of smoking. But as the ill-effects of smoking show off slowly and gradually and a smoker becomes a victim to atherosclerosis, Buerger's Disease and a whole range of other smoking induced ailments, he fins no way out other than opting for the antismoking medicine Chantix. For more details on chantix, log in to the site http://www.chantixhome.com..

Vocal EK said...

Dr. Mintz: It's time for an update. The University of Alberta has completed a survey of electronic cigarette users and found that 79% have been able to give up all tobacco smoking. You can read the preliminary report: http://www.tobaccoharmreduction.org/wpapers/011v1.pdf

An ongoing poll with over 1400 responses on our user forum shows that 81.79% have replaced all their tobacco cigarettes, and another 17.57% have reduced the number smoked (http://www.e-cigarette-forum.com/forum/polls/6470-e-cig-success-rate.html).

Thousands of people have now been using an electronic cigarette for well over six months (longer than many clinical trials go) and there have been no serious health problems reported. There have been many, many reports of being able to breathe better, disappearance of wheezing and coughing, reduced need for asthma medication, lower blood pressure, and lower cholesterol -- the same beneficial effects you see for folks who have stopped smoking tobacco using some other method.

So there is evidence that indicates the electronic cigarette is effective for those who want to use it as a healthier replacement for tobacco smoking.

I disagree with the assertion that it is healthier to stop using nicotine. That is not true for everyone.

Dr. Mintz, please learn all you can about the effects of nicotine on cognitive and emotional health. Even as I write this, there is a company conducting clinical trails on drugs they developed that are based on nicotine for treatment of Attention Deficit Disorder, Alzheimer's Disease, Parkingson's Disease, anxiety, and depression. Nicotine can treat these diseases! Why you you think so many smokers who try to give up nicotine become anxious and depressed, can't concentrate, can't remember, can't function? More importantly, why--for many people--do these problems persist for months or years and only resolve when smoking (or some other source of nicotine) is resumed?

In addition to surveys and tens of thousands of cases of anecdotal evidence, we have common sense. Tobacco cigarettes deliver nicotine, tar, carbon monixide, and thousands of toxins. Electronic cigarettes deliver nicotine and a tiny fraction of the toxins found in smoke. Which sounds better?

In conclusion, I must disagree with you tha--if they can't quit-- smokers should just continue to inhale tobacco smoke until we have absolute proof that electronic cigarettes are safer. Clinical trials take years to accomplish. Think of the lung disease, the heart attacks, the strokes, and the cases of cancer that will occur during those years while smokers wait for the confirmation that electronic cigarettes are a safer way of obtaining nicotine than smoking.

We have no time to waste here. The sooner we can switch continuing smokers to inhaling vapor, the more lives we will save. There is a tremendous amount of suffering that can be avoided.

Dr. John M. Hester said...

And yet Chantix is safe? You have to be kidding! That stuff should be black boxed, or better yet, taken of the market!
That aside, Dr. Mintz, I would like to invite you to go to www.vaportalk.com and check out our community of e-smokers who feel better, are healther, and have kicked the tobacco habit because of our personal vaporizers.
I have no financial interest in this issue at all. But I do believe we have the potential to provide smokers with a safer alternative to traditional cigarettes.
So please visit our forum. Lurk if you wish, join if you like, but I feel you might see a different side of this issue.
Dr. John M. Hester

PC - said...

truth about e-cig's
They are 90x Safer then conventional cigarette's.

Why do I say this?
cigarettes have over 4000 different carcinogens in them.
E-cig well if you consider nicotine a carcinogen pg or glycol a carcinogen then think about it.

Whether or not a type of liquid is used to make anti-freeze.

How come nobody talks about what chemicals are used to dry out tobacco leaves? And all the other chemicals sprayed on them.

Im sure none of you understand the concept of any of it.

The worst thing with a e-cig is the nicotine. I will admit it.

Cigarette smokers are addicted to nicotine & other carcinogens preventing them to stop smoking & to alter there mind.

I am almost a 2 pack a day Marlboro smoker. And Hoping I could get the stink of cigarettes away and the loss of energy back when I fully start with a e-cig.

First steps will be to start cleaning everything to get rid of the residue of cigarettes all over walls fans carpet etc.

Second step Concentrate on the e-cig to be my main smoke instead of a Smelly tobacco product that is killing me.

I have taken the e-cig into many stores & restaurants. Many people look at me funny and ask me what it is that I have.
I tell them Im trying to stop smoking. And patches and gum does not work for me. doesn't even help.

And for the prescriptions they have so many side effects they can kill you.

True Story is 1 of my Friends of 25years. her husband Tried to kill her while he was sleeping.
he was having a nightmare Had her pinned She was barely breathing by the time he was woke up.
She couldn't do anything. he immediately stopped taking those pills. And has never had any issues since.

Why? Cause the pills to help you stop smoking have severe side affects that most people getting prescribed do not know.

Could you imagine a prescription a dr tells you is safe.. Takes and almost causes you life in prison?


I could go off and tell you exactly Why all this is happening & other things but How many truly wish to research for themself?

75% of us that smoke e-cigs have researched every ingredient Side effects and other things related to it.

Has any of the dr's that are not for it Doing that?
NO they are not. They are just doing basics and trying to find bad reasons for it.

The only bad thing about a e-cig is The nicotine.. You Can make your own Juices in your own home. LEGALLY YES LEGALLY..

And yes the FDA Has approved The Ingredients But they have not approved them when combined.

Nictine inhalers, Patches all use Nicotine.

Other ingredients are or can be used in Making your shampoo lotions food products And also diesel fuel anti freeze and lots more.

I can goto walmart, rite aid, safeway, walgreens & Lots more and buy 1 of the ingredients in the beauty isle & in the medical section.

other ingredient is flavoring Non Toxic & Safe.

Another ingredient is distilled water.

Come on people think before you judge.

America's number 1 problem is judging before you have the facts & know the truth...

Research before you open your mouth & Judge.

Most health food stores carry all the Ingredients for nicotine free liquid.

And yes 1 of the ingredients is used in making toxic things.
And it is very pure at the least.

and is used in medical over the counter drugs use it prescription drugs use it.

Just wish everyone would understand and know the truth about everything before they take and judge a book by its cover.



I just wish everyone would have common sence.

Kuya said...

Chantix is not a stop smoking cure..
It may help 50%
& may kill 20%
Or else it may Cause you to goto prison for killing someone.

Read all the stories that has been happening to people taking chantix.
and other drugs..

Look at all the side effects.

including the 70-80yr old lady who took it and was having sexual dreams and in no way wanted off the pill.

or how about the attempted murders or suicides due to the pill?

E-Cig is much safer.

yes We know there trying to regulate us.
and control us more and more.

Prescriptions are safe for us..
Cigarettes are safe for us.

And a little vapor machine is not safe.. the little e-cig vaporizer is no worse the a fog machine.
Drip a little juice on the element
Take a puff..
The smoke enters your mouth. But the liquid does not.

Yes nicotine is unsafe. But used in many many things.
Also used around your house. in some fertalizers and lots more.
also used to kill things..

Oh ya what about how they prescribe strict 9 Yes rat poison to be a blood thinner...

electronic cigarette said...

very interesting topic thanks for the post.

Vocal EK said...

It has now been over a year that I have been smoke-free because I switched to inhaling vaporized nicotine from an electronic cigarette. Despite the fact that well over a million units have been sold in the U.S. during the past 2 years, there are zero reports of serious adverse effects caused by electronic cigarettes. That's not so surprising when you know the whole truth.

We now know that the FDA purposely misled the public when they made their announcement last summer, by putting a major "spin job" on the lab results. Do you want to make people think that electronic cigarettes are more toxic than tobacco cigarettes? Just leave out the fact that one potentially toxic chemical was present in such a miniscule amount that a consumer would need to vaporize thousands of cartridges in a day to reach toxic levels. And it is very strange that dozens of labs have tested numerous brands of cartridges and liquid and not one has duplicated the FDA findings. Let me repeat that: No other lab has ever found any DEG in an electronic cigarette cartridge.

FDA wanted the public to believe that electronic cigarettes would cause cancer even faster than tobacco cigarettes. Thus, FDA announced gleefully that its testing "detected" carcinogens, without providing a clue about the quantity present. Health New Zealand determined that the quantity of Tobacco-Specific Nitrosamines (TSNAs) in the 16 mg. cartridge is 8 nanograms. Health New Zealand put this quantity into perspective by noting that 8 nanograms is also the amount found in a "medicinal nicotine patch". In contrast, a Marlboro contains 11,180 nanograms of TSNAs.

But wait, there's more: Electronic cigarette users do not drink the liquid--they vaporize it. NJOY hired an outside laboratory to test the TSNAs in both the liquid and the vapor. That lab found that only one type of TSNA makes it into the vapor, and that particular TSNA is not carcinogenic. You can access a collection of lab reports at http://www.casaa.org/resources/lab.asp

In summary, yes, electronic cigarette liquid, just like your drinking water, does contain minute amounts of toxins and carcinogens, but not in sufficient quantity to endanger consumers.

I can't believe that FDA scientists were too dim to comprehend this. I do believe that Josh Scharfstein masterminded the spin job that endangered the lives of every smoker who read the news reports and decided, as a result, to continue inhaling smoke instead of switching to vapor.