On Wednesday morning, The American Legacy Foundation presented a panel discussion on, “Are E-cigarettes a bridge product to smoking, abstinence or neither?”. Cheryl Heaton, DrPH, President and CEO of The American Legacy opened the session commenting that until July of this year, when the FDA conducted a small pilot program, there was no scientific evidence or research but plenty of anecdotal stories about how these products are being used. There is concern in the health care field that unlike tobacco products that are required to carry health warnings, e-cigarettes do not have health warning and they come in flavors such as chocolate that appeal to children. Flavored cigarettes were banned when the Family Smoking and Prevention Act was signed into law in June with a letter from the FDA going out last Monday to the tobacco companies regarding this.
Dr. Nathan Cobb said that the preferred name for this product is Electronic Nicotine Delivery System (ENDS) since they do not fit the definition of a cigarette, which is tobacco rolled in paper. While there are many different products, they share several of the same components: a battery, heating element, filter that contains nicotine, flavorings and propylene gycol. As the user inhales and the propylene gycol is heated to 40 to 65 degrees centigrade and is drawn through the device, it vaporizes and carries the nicotine along with it. Propylene gycol is found in many food products and is generally considered as safe, however, in high doses, it can cause kidney and liver damage. There has been no research whether is it safe to be inhaled through the lungs or if there are dangerous products that are released as it is absorbed in the lining of the lungs, especially when if it is used frequently throughout the day and for long periods of time. Another concern is that there is no quality control and some companies are using other substances in the nicotine cartridge. The cartridge can be refilled with nicotine liquid which is sold in small amounts of about 1 gram, about the amount that would fill a shot glass. Because the product is not sold in a taper proof container, it should be kept away from pets and children because this amount could be a toxic or legal dose. Children could be particularly at risk since propylene gycol has a sweet taste that children may like. One teaspoon of nicotine is enough to kill a child.
Manufacturers of e-cigarettes claim that their product contains less harmful substances than cigarettes and that their product is more like a cigarette and not a nicotine replacement product, so the FDA does not have the authority to regulate this product. Unfortunately, until recently the FDA was barred by the Supreme Court from conducting any regulation of cigarettes, so there is no framework to evaluate tobacco products and health claims. As a nicotine delivery system, safety and efficacious issues need to be addressed which is difficult, since there is no single standard for ENDS. Questions of quality control, are there unintended consequences from the use, safety issues and is it really an alternative to smoking are all questions that need scientific research.
The FDA conducted a small pilot study comparing Njoy, Smoking Everywhere and the Nicotine Inhaler, a medicinal product available by prescription only. The nicotine cartridges were analyzed specifically for nicotine, tobacco smoke alkaloids, TSNA’s, and Diethylene gycol (DEG). For the two ENDS, it was found that the product delivered less nicotine than was stated on the package (Smoking Everywhere, 16mg stated vs. 5.98mg found, Njoy, 18mg stated vs. 6.76mg found). One cartridge contained DEG which is not found in cigarettes and anabasine was detected in some cartridges, along with trace amounts ot TSNA’s, a cancer causing substance that is also found in tobacco products. Some 0 nicotine cartridges did contain nicotine. The FDA study had testing limitations, in there was limited chemical assessment, a machine was used to detect the amounts of nicotine inhaled which may be different than the way a human would inhale and it was not tested on humans to see if there were different biomarkers involved.
A report that is often quoted by manufacturers was funded by Runyan Ltd and was conducted by a private company, Health New Zealand. Their report has the same limitations as the one done by the FDA. Health New Zealand found that the cartridges contained TSNA’s, acetaldehyde, acetone, formaldehyde and polycyclic aromatic hydrocarbons (PAH’s) at lower levels than cigarettes but higher than nicotine replacement products that are FDA approved. Propylene gycol was declared virtually non-toxic but the effects of the electronic heating was not tested for long term toxicity. There are frameworks in place that where research could be done as to answer safety and quality control issues within a reasonable amount of time. If ENDS were to be found to be safe, there might still be risks that the users would need to be informed of but these can only be determined through adequate studies.
Besides the safety and quality control issues, there are behavioral issues that raise concerns. Is this a product that will wean smokers off cigarettes or will it be a bridge product that is used instead of cigarettes and prevents quit attempts? Will it entice former smokers to resume smoking? Will it serve as a gateway for new smokers?
The take away message from the panel is that currently it is impossible for a consumer to make an informed decision about ENDS and that the product should be banned until safety and efficacy studies are properly conducted.
Comments
So the takeaway message is "just keep smoking." Unless some huge whoppers have been told to us about the dangers of cigarette smoking, a product would have to have to be mighty harmful to do as much damange as smoking tobacco. We still have 45 million smokers in this country who have already tried the so-called "effective" treatments and have not been able to stop smoking. It is estimated that 200,000 of these have managed to transfer over to e-cigarettes and now find tobacco cigarettes distasteful. So the take away message is "We want to ban these because they MIGHT be harmful, and meanwhile you should go back to smoking tobacco cigarettes that we KNOW are harmful."
VocalEK, Of course they want us to keep smoking cigarettes. How else are they going to be able to charge us an arm and a leg in taxes? Not to mention that most of the more vocal detractors such as ASH, ALA, and others derive a lot of their funding from Big Pharma (makers of the ineffective and even deadly smoking cessation aids, Chantix anyone?), who just happen to be the companies with the most to lose if e-cigs aren't banned.
It amazes me that our wonderful government agencies would rather we continue to kill ourselves with tobacco rather than use a much safer alternative.
Who is the American legacy foundation and why would I care about their panel's findings? I wonder if they have their own agenda:
tobaccoanalysis.blogspot.com/2005/05/american-legacy-foundation-tactics-to.html
Thanks for your recommendation that I either continue to smoke cigarretes or try and quit with $$$FDA approved pharmaceutical sources of Nicotine that don't even work.
I have been smoke free for over seven months using my personal vaporizor(e-cig) and my doctor and I both agree that my body is in a lot better shape than it was while I was smoking.
While I agree that we don't know everything about the long term effects of these devices, we do know the about the long term effects of cigarettes: There are none because they kill you.
I've made my uninformed decision and will let you know about the long term effects of e-smoking when I get there.
I find it extremely interesting that there was a report done in response to the "FDA conducted a small pilot program" by Exponent, one of the US's leading research labs, noting the issues with the FDA report.
Just a few snipits:
* The report failed to present standard protocols for proper study design with regards to the testing of the referenced control device, documenting the number of samples tested
either within or across tests, or presenting statistical analyses when quantifiable results were obtained.
* All of the tobacco-associated impurities found in the NJOY products were “present but at less than the level of the Nicotrol® inhaler [manufacturer] specification” according to the FDA report.
* The report does not reflect the actual dose of nicotine delivered to the user from the “control” Nicotrol® inhaler device when used as recommended by the manufacturer (6–16 cartridges/day or 24–64 mg of nicotine, 50 mcg/100 mL puff).
Why is THIS report being ignored?
Yes, that is what I am--dumb founded over the dumbness of this. How could anyone in their right mind tell an ENDS user to stay on tobacco OR GO BACK TO SMOKING IT.
As for the name ENDS, until this article I've never heard it called that but this could be fitting since it could bring an END to humans inhaling something that is burning. And ask anyone, inhaling smoke is the real danger here.
This article also left out the fact that most of the stuff found in the liquid was also found in FDA approved stop smoking products.
Makes me wonder who financially supports this so called group.
The posts prior to mine are very good and informative however something the article mentions that always gets to me is the belief that having differnet flavors is just to get kids into smoking or using e-cigs. I completely disagree, I'm 38 years old and the 3 flavors I'm currently using in my e-cig are chocolate mint, strawberry and vanilla ice cream. Recently some of my co-workers brought some grape flavored and raspberry flavored cigarillos to work and I liked them as well. Just because there is a candy or fruit flavor does NOT mean it's for kids. The APPROVED nicotine replacement gum comes in fruit flavor....does that mean they are trying to get kids to buy nicorette gum which contains nicotine?
I have been using the E-cig/END for over a year and I am a grown woman, and I guess my taste buds are about 10 years old. Why as a adult will I have to give up all those flavors, I so love. I addressed this Issue because the others LaceyUnderall,AngusATAT, Dumb founded, NoLongerASmoker,VocalEK all address the other issues. One other thing, I did not start out to give up those killer cigarettes, the flavors helped me make the transition. My doctors are really pleased with my health improvement. I have spend more time researching all the stuff in/about E-cigs than the person that wrote this article. Cigarette will kill me for sure, tar and other stuff in cigarettes cause permanent damage. I will take my educated risk with E-cigarette over lungs full of tar from burning cigarettes.
It's interesting to me that people keep claiming that no studies have been done on inhaling Propylene Glycol, when in fact it has been studied for over 60 years. It was studied by the medical field and is used as the suspension liquid for asthma inhalers and nebulizers. It has been studied by OSHA for use in fog machines due to so many stage workers being exposed to it at plays and concerts. It has been studied by the military for use as a vaporized anti-microbial, and they found it safe but went with another method that was less expensive. It is used in a vaporized form to clean hospitals, food prep areas, and hotels. If you are going to write an article like this it might be worthwhile to do as much research as I was able to do from home with no training in research or journalism.
Also, after smoking for 23 years I have switched to PVs (e-cigs) for the past 3 months. The taste of a cigarette now repulses me even though I loved it for 23 years. I am healthier and happier.
I find it very difficult to heed the advice from any panel that bases its decision partially on the merits of its own short 2-page "fact" sheet which merely contains assumption, opinion and what appears to be one-sided fact.
*The American Legacy Foundation's "Electronic Cigarette Fact Sheet" can be found in .pdf format on their website.
Who is the American legacy foundation and why would I care about their panel's findings? I wonder if they have their own agenda:
tobaccoanalysis.blogspot.com/2005/05/american-legacy-foundation-tactics-to.html
Thanks for your recommendation that I either continue to smoke cigarretes or try and quit with $$$FDA approved pharmaceutical sources of Nicotine that don't even work.
I have been smoke free for over seven months using my personal vaporizor(e-cig) and my doctor and I both agree that my body is in a lot better shape than it was while I was smoking.
While I agree that we don't know everything about the long term effects of these devices, we do know the about the long term effects of cigarettes: There are none because they kill you.
I've made my uninformed decision and will let you know about the long term effects of e-smoking when I get there.
On my 50th birthday, a friend gave me an electronic cigarette as a gift so I wouldn't "have to go outside to smoke when visiting". As incredible as it sounds, after 35 years of smoking 1.5 to 2 packs of cigarettes a day, I haven't smoked a tobacco one since that day, over two months ago! The first couple of weeks I used the e-cig quite frequently, but currently I'm using zero nicotine liquid (menthol) and I'm down to using it three or four times a day for maybe ten vapes at a time. I regained my sense of smell after about a week and, as of this writing, my breathing capacity (as measured by a peak flow meter) has improved by almost thirty percent. Based on my own experience, I believe that the electronic cigarette addresses the behavioral aspects (handling, inhalation, ritual) of smoking that are lacking in NRT products, and that they're definitely an aid in smoking cessation. I feel great, and I smell pretty darn good too. Go after big tobacco with your ban; leave these alone!
I am disappointed that the American Legacy Foundation seems to have adopted the "quit or die" philosophy. While some people have been able to quit cigarettes with government-approved NRTs, the success rates are pitifully small. In fact, I was unable to quit using the patch, inhaler, nicotine gum, Zyban, or Chantix. And with Chantix, I had the added "bonus" of developing severe depression, something I had never experienced before in my life.
With e-cigarettes, though, I have been tobacco-free for 7 months with absolutely no desire for cigarettes. For someone who smoked 2+ packs a day for 30 years, that's nothing short of a miracle. Certainly, testing should continue, but to ban e-cigs in the interim seems to me to be nothing short of a crime.
As for the fact that some flavors may appeal to kids, well, I guess we ought to ban fruity alcohol drinks as well as Nicorette fruit chill flavor, to name just a few.
Sometimes a little common sense goes a long way.
Wow, just wow.
Maybe someday some day true journalism will poke it's head into the picture and intercede on behalf of reason and logic and truth. Until that time comes, let me just say that electronic cigarettes are a Godsend, and have elinimated my tobacco burning habit. And anyone that opposes them really appears to have an agenda, because there is no logical reason to do so.
If someone could just supply one logical reason not to use electronic cigarettes to save their lives, I will be happy to listen. But I already know from my months of research that no such reasons will be forthcoming, so I will continue to recommend these products to all I know, and all smokers I see on the streets of my world, and I will fight for the right of all smokers to have this option to save their very lives.
Yeah, maybe a bit dramatic, but oh so true.
The non-tobacco flavors are what got me, a 42 year old woman and 20+ year smoker, to stop craving tobacco cigarettes. Thank GOD for those great ADULT flavors!
My 16 & 18 year old sons have said the flavors are absolutely NOT any incentive to try them.
Why do people find the concept of "harm reduction" so difficult to understand?
Using a parachute is not 100% safe. But it is MUCH safer than jumping out of a plane without one.
These devices are not proven "safe," but they are MUCH safer than the alternative - smoking tobacco. The FDA's own tests have PROVED this. TRACE AMOUNTS compared to tobacco cigarettes.
CORRECTION: Cigarettes DO contain DEG. Propylene glycol HAS been tested safe for inhalation. MANY liquids use child safety caps. Nicotine poisoning w/ child = 1 tsp is for PURE nicotine, not mixed with PG.
IF YOU TAKE AWAY THESE DEVICES, PEOPLE WILL NOT QUIT SMOKING - THEY WILL RETURN TO SMOKING TOBACCO CIGARETTES.
Is that REALLY what you want?
"The take away message from the panel is that currently it is impossible for a consumer to make an informed decision about ENDS and that the product should be banned until safety and efficacy studies are properly conducted."
The above statement is so shockingly stupid. We know for a fact that cigarettes are not safe and according to the Foundation you are not sure about the saftey of the e-cig. So therefore, I should not use the e-cig and continue to smoke my Marlboro Lights. Do you know how assanine this sounds?
I know for a fact that e-cigs are much safer than regular cigarettes. Tell me how could they be any worse? Really!!
First let me suggest that the "device" is NOT an END. This is a concocted new acronym for an E-Cig or Personal Vaporizer which I'm sure the FDA would like to change these into.
Second, the E-Cig or PV should not be what we are talking about here. If something should come under the jurisdiction of the FDA, since they now have jurisdiction over tobacco, it should be the E-juice. They are two separate things and that should not be confused. The PV does not HAVE to be used to deliver nicotine. Many now vape nicotine free because they enjoy the flavors and, I'm sure, the habit of smoking. Those things that are almost as addicting as nicotine. Having the hand to mouth movement for many is so ingrained at this time that it is difficult to do without. That may sound strange to a non-smoker, but all of us that have done this for many years full well know from where I speak.
If a BAN is tried, it will be met with resistance- just like alcohol and marijuana. This is too big an issu
Do you know how many people died because they didn't know that aspirin could prevent lethal heart attacks?
The FDA knew, but they wouldn't allow the manufacturers to mention that little fact.
Since it went on for years, no one is really sure how many thousands of people were allowed to die prematurely due to the short-sighted draconian rules of the FDA. There's a long list of similar situations that have occurred and are occurring today.
It's pretty obvious that we are looking at a similar situation with e-cigarettes.
The cure for smoking is too simple for the so-called experts to comprehend. Replace the smoke with something more benign. It's not hard because few things can match smoke in the harm department.
Looks like the ALF panel of experts slept through biology?
I've always wondered what it takes to be an uninformed lemming. So I thought i'd pop in to take a look. Now I know.
All you have to do is follow the lead of other uninformed lemmings. Luckily, I am one of the informed few who made an informed decision to quit smoking using a personal vaporizer. My life is now a lot better without the bronchitis and various other chest infections caused solely by smoking cancer inducing tobacco cigarettes.
Apparently you people don't get it. The only thing that is safe is to not smoke at all!!! I am a laryngectomee and if you don't know what that is I have lost my vocal chords to smoking in the past. I quit 14 years ago. Keep on smoking. You, too , can be a
laryngectomee!!!
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