Based on the best available scientific evidence, I have compiled a list of the identified, known carcinogens present at greater than trace quantities in electronic cigarettes compared to conventional cigarettes.
Below that list is a table listing a number of anti-smoking organizations and which of the two products they have stated or implied they would prefer that smokers smoke.
Table 1. List of Identified, Known Carcinogens in Electronic Cigarettes, Present at More than Trace Levels (defined as 1 nanogram per cigarette)
None
Table 2. List of Identified, Known Carcinogens in Tobacco Cigarettes, Present at More than Trace Levels (defined as 1 nanogram per cigarette)
Benz(a)anthracene
Benzo(b)fluoranthene
Benzo(j)fluoranthene
Benzo(k)fluoranthene
Benzo(a)pyrene
Dibenz(a,h)anthracene
Dibenzo(a,l)pyrene
Dibenzo(a,e)pyrene
Indeno(1,2,3-cd)pyrene
Quinolineb
Dibenz(a,j)acridine
Benzo(b)furan
Furan
N-Nitrosodimethylamine
N -Nitrosoethylmethylamine
N -Nitrosodiethylamine
N -Nitroso-di-n-butylamine
N -Nitrosopyrrolidine
N -Nitrosopiperidine
N -Nitrosodiethanolamine
N -Nitrosonornicotine
4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone
2-Toluidine
2,6-Dimethylaniline
2-Naphthylamine
4-Aminobiphenyl
AaC
PhIP
Formaldehyde
Acetaldehyde
1,3-Butadiene
Isoprene
Benzene
Styrene
Acetamide
Acrylamide
Acrylonitrile
Vinyl chloride
DDT
DDE
Catechol
Caffeic acid
1,1-Dimethylhydrazine
2-Nitropropane
Nitrobenzene
Ethyl carbamate
Ethylene oxide
Propylene oxide
Methyleugenol
Hydrazine
Arsenic
Nickel
Chromium
Cadmium
Lead
Polonium-210
Table 3. Type of Cigarette that Anti-Smoking Groups Have Stated or Implied They Would Rather Have Smokers Smoke
Campaign for Tobacco-Free Kids: Tobacco Cigarettes
American Lung Association: Tobacco Cigarettes
American Heart Association: Tobacco Cigarettes
American Cancer Society: Tobacco Cigarettes
Action on Smoking and Health: Tobacco Cigarettes
Americans for Nonsmokers' Rights: Tobacco Cigarettes
Association for the Treatment of Tobacco Use and Dependence: Tobacco Cigarettes
Dr. Michael Siegel: Electronic Cigarettes
The Rest of the Story
What kind of absurdity is this? The major anti-smoking groups would much rather that smokers smoke tobacco cigarettes than that they quit smoking and use electronic cigarettes, even though the tobacco cigarettes have been shown to contain at least 57 known carcinogens at significant levels while the electronic cigarettes have not been shown to contain any carcinogens at more than trace levels.
Are the anti-smoking groups actually telling smokers that they would be better off smoking a product which is known to expose them to 57 carcinogens than to smoke a product which exposes them to 0 identified carcinogens?
Actually, that's exactly what they are telling smokers.
The anti-smoking groups have thick ideological blinders on which are unfortunately precluding these groups from having any sense of public health perspective. They are living in a fantasy land in which they have convinced themselves that electronic cigarettes pose a greater threat to the public's health than conventional cigarettes.
The rest of the story is that electronic cigarettes are not what are killing people. It's the damn real ones.
And it's a tragedy that these anti-smoking groups would rather condemn smokers to the most toxic known consumer product, rather than tolerate the fact that the use of this much safer product involves a smoking-like behavior. It is that smoking-like behavior which is driving the anti-smoking groups nuts. They simply cannot tolerate that. No matter how many lives it might save.
...Providing the whole story behind tobacco and alcohol news.
Friday, July 31, 2009
Thursday, July 30, 2009
Comparison of Carcinogen Levels Shows that Electronic Cigarettes are Much Safer Than Conventional Ones
The FDA last week condemned electronic cigarettes on the basis that an FDA laboratory detected carcinogens (tobacco-specific nitrosamines) in the cartridges of several electronic cigarette manufacturers. The FDA held a press conference in which it attempted to scare electronic cigarette users into discontinuing e-cigarette use (and therefore a return to conventional cigarette smoking). In addition, a number of anti-smoking groups, including the Campaign for Tobacco-Free Kids and American Lung Association, have called for a ban on these products due to this carcinogen scare.
The FDA (and the anti-smoking groups), however, failed to do three important things:
First, they failed to disclose the levels of tobacco-specific nitrosamines that were detected in the electronic cigarette cartridges.
Second, they failed to test the control product (a nicotine inhaler) to determine the carcinogen level in that product.
Third, they failed to report the tobacco-specific nitrosamine levels in conventional tobacco products, including cigarettes.
The Rest of the Story
Because of the FDA's and the anti-smoking groups' omissions, there is a need to get the rest of the story out there to the public. And here it is, in this table:
As these data show, the level of tobacco-specific nitrosamines present in electronic cigarettes is at the trace level. It is measurable in parts per trillion (nanograms per gram). It is comparable to the nitrosamine levels in nicotine replacement products which are approved by the FDA.
In contrast, the level of tobacco-specific nitrosamines present in tobacco products are 300 to 1400 times higher. On a weight-for-weight basis, Marlboro has 1400 times higher the level of tobacco-specific nitrosamines than an electronic cigarette cartridge. And keep in mind that these represent the levels in the cartridges and cigarettes, not in the tobacco smoke or e-cigarette vapor which are directly inhaled. Because of the much higher temperatures generated in tobacco combustion compared to propylene glycol vaporization, the delivery of these carcinogens into the vapor is expected to be much lower than into the tobacco smoke.
Moreover, there are approximately 56 other carcinogens that have been identified to be present at high levels in tobacco smoke, while there are no other carcinogens that have been identified to be present in electronic cigarettes.
Based on these data, and upon knowledge that the conventional cigarette contains at least 10,000 other chemicals, including known toxins and carcinogens, while the electronic cigarette does not, there is exceedingly strong evidence that electronic cigarettes are much, much safer than conventional ones.
This does not mean that there are not issues that need to be addressed with electronic cigarettes. The diethylene glycol that was present in one cartridge tested suggests that more widespread and systematic testing should be done to identify the extent of this problem. Testing is also necessary to determine whether the diethylene glycol actually makes it into the e-cigarette vapor/mist. The problem should be able to be addressed easily, since high-grade propylene glycol - which is almost entirely free of diethylene glycol - is readily available.
Appropriate procedures also need to be in place, if they are not already, to ensure that electronic cigarettes are not available to minors.
However, what this calls for is the FDA working with the electronic cigarette manufacturers and distributors to study the product and address the identified problems. It does not call for the FDA to ban the product or pull it from the market.
This research is not the only work that has established that electronic cigarettes are much safer than conventional cigarettes. Research conducted by Dr. Murray Laugesen and Health New Zealand Ltd. reveals that the toxic emissions score for electronic cigarettes is much lower than that of conventional cigarettes. In fact, the toxic emissions score - which is a score based on the levels of 59 priority toxicants - was zero for electronic cigarettes. In contrast, it was 126 for Marlboro and it was no lower than 100 for any brand of conventional cigarette tested.
Note that the above study actually tested the electronic cigarette vapor. This is the most relevant test, because it determines what the user actually inhales. The study found no more than trace levels of any of the 59 priority toxicants.
The study concluded: "Ruyan® V8 nicotine e-cigarette users do not inhale smoke or smoke toxicants. The modest reductions recommended in 2008 by WHO’s Tobacco Regulation committee for 9 major toxicants in cigarette smoke, in line with Articles 9 and 10 of the FCTC (WHO Framework Convention Tobacco Control treaty), are already far exceeded by the Ruyan® e-cigarette, as it is free of all accompanying smoke toxicants. Absolute safety does not exist for any drug, but relative to lethal tobacco smoke emissions, Ruyan e-cigarette emissions appear to be several magnitudes safer. E-cigarettes are akin to a medicinal nicotine inhalator in safety, dose, and addiction potential. E-cigarettes are cigarette substitutes. If they can take nicotine market share from cigarettes, and that is the big question, they will improve smoker and population health. They may also have a secondary role as medicinal nicotine inhaler quitting aids. Further trials of acceptability, addiction potential, clinical safety, and quitting efficacy are needed."
It should also be noted that there is preliminary research which provides laboratory evidence that electronic cigarettes are as effective as nicotine replacement products for short-term smoking cessation (i.e., these products have been shown to provide relief of cigarette cravings at a level comparable to nicotine replacement products). This research found that electronic cigarettes are actually preferable to a nicotine inhaler in terms of helpfulness, pleasantness, and ratings of whether the smoker would use the product and recommend the product. Given the overwhelming anecdotal evidence of the effectiveness of e-cigarettes for smoking cessation, formally studying the longer-term effectiveness of these products is a research priority.
Electronic cigarettes have the potential to be a life-saving intervention for millions of smokers. The FDA and the anti-smoking groups need to embrace this product and support the appropriate testing, not remove it abruptly from the market and sentence over a million e-cigarette users to disease and even death by a return to conventional cigarettes.
The FDA (and the anti-smoking groups), however, failed to do three important things:
First, they failed to disclose the levels of tobacco-specific nitrosamines that were detected in the electronic cigarette cartridges.
Second, they failed to test the control product (a nicotine inhaler) to determine the carcinogen level in that product.
Third, they failed to report the tobacco-specific nitrosamine levels in conventional tobacco products, including cigarettes.
The Rest of the Story
Because of the FDA's and the anti-smoking groups' omissions, there is a need to get the rest of the story out there to the public. And here it is, in this table:
Maximum Tobacco-Specific Nitrosamine Levels in Various
Cigarettes and Nicotine-Delivery Products
(ng/g, except for nicotine gum and patch which are ng/patch or ng/gum piece)
| Product | NNN | NNK | NAT | NAB | Total |
| Electronic cigarettes (2) | 3.87 | 1.46 | 2.16 | 0.693 | 8.183 |
| Nicotine gum (1) | 2.00 | Not detected | Not detected | Not detected | 2.000 |
| Nicotine patch (1) | Not detected | 8.00 | Not detected | Not detected | 8.000 |
| Swedish snus (3) | | | | | 2400 |
| Winston (1) | 2200 | 580 | 560 | 25 | 3365 |
| | 1100 | 830 | 1900 | 55 | 3885 |
| Marlboro (3) | | | | | 6600 |
| Camel (1) | 3100 | 1400 | 2800 | 150 | 7450 |
| Skoal (1) | 4500 | 470 | 4100 | 220 | 9290 |
| Marlboro (1) | 4300 | 1800 | 4900 | 190 | 11,190 |
Sources:
- Stepanov I, Jensen J, Hatsukami D, Hecht SS. Tobacco-specific nitrosamines in new tobacco products. Nicotine & Tobacco Research 2006; 8:309-313. (Link)
- Laugesen M. Safety Report on the Ruyan e-cigarette Cartridge and Inhaled Aerosol.
As these data show, the level of tobacco-specific nitrosamines present in electronic cigarettes is at the trace level. It is measurable in parts per trillion (nanograms per gram). It is comparable to the nitrosamine levels in nicotine replacement products which are approved by the FDA.
In contrast, the level of tobacco-specific nitrosamines present in tobacco products are 300 to 1400 times higher. On a weight-for-weight basis, Marlboro has 1400 times higher the level of tobacco-specific nitrosamines than an electronic cigarette cartridge. And keep in mind that these represent the levels in the cartridges and cigarettes, not in the tobacco smoke or e-cigarette vapor which are directly inhaled. Because of the much higher temperatures generated in tobacco combustion compared to propylene glycol vaporization, the delivery of these carcinogens into the vapor is expected to be much lower than into the tobacco smoke.
Moreover, there are approximately 56 other carcinogens that have been identified to be present at high levels in tobacco smoke, while there are no other carcinogens that have been identified to be present in electronic cigarettes.
Based on these data, and upon knowledge that the conventional cigarette contains at least 10,000 other chemicals, including known toxins and carcinogens, while the electronic cigarette does not, there is exceedingly strong evidence that electronic cigarettes are much, much safer than conventional ones.
This does not mean that there are not issues that need to be addressed with electronic cigarettes. The diethylene glycol that was present in one cartridge tested suggests that more widespread and systematic testing should be done to identify the extent of this problem. Testing is also necessary to determine whether the diethylene glycol actually makes it into the e-cigarette vapor/mist. The problem should be able to be addressed easily, since high-grade propylene glycol - which is almost entirely free of diethylene glycol - is readily available.
Appropriate procedures also need to be in place, if they are not already, to ensure that electronic cigarettes are not available to minors.
However, what this calls for is the FDA working with the electronic cigarette manufacturers and distributors to study the product and address the identified problems. It does not call for the FDA to ban the product or pull it from the market.
This research is not the only work that has established that electronic cigarettes are much safer than conventional cigarettes. Research conducted by Dr. Murray Laugesen and Health New Zealand Ltd. reveals that the toxic emissions score for electronic cigarettes is much lower than that of conventional cigarettes. In fact, the toxic emissions score - which is a score based on the levels of 59 priority toxicants - was zero for electronic cigarettes. In contrast, it was 126 for Marlboro and it was no lower than 100 for any brand of conventional cigarette tested.
Note that the above study actually tested the electronic cigarette vapor. This is the most relevant test, because it determines what the user actually inhales. The study found no more than trace levels of any of the 59 priority toxicants.
The study concluded: "Ruyan® V8 nicotine e-cigarette users do not inhale smoke or smoke toxicants. The modest reductions recommended in 2008 by WHO’s Tobacco Regulation committee for 9 major toxicants in cigarette smoke, in line with Articles 9 and 10 of the FCTC (WHO Framework Convention Tobacco Control treaty), are already far exceeded by the Ruyan® e-cigarette, as it is free of all accompanying smoke toxicants. Absolute safety does not exist for any drug, but relative to lethal tobacco smoke emissions, Ruyan e-cigarette emissions appear to be several magnitudes safer. E-cigarettes are akin to a medicinal nicotine inhalator in safety, dose, and addiction potential. E-cigarettes are cigarette substitutes. If they can take nicotine market share from cigarettes, and that is the big question, they will improve smoker and population health. They may also have a secondary role as medicinal nicotine inhaler quitting aids. Further trials of acceptability, addiction potential, clinical safety, and quitting efficacy are needed."
It should also be noted that there is preliminary research which provides laboratory evidence that electronic cigarettes are as effective as nicotine replacement products for short-term smoking cessation (i.e., these products have been shown to provide relief of cigarette cravings at a level comparable to nicotine replacement products). This research found that electronic cigarettes are actually preferable to a nicotine inhaler in terms of helpfulness, pleasantness, and ratings of whether the smoker would use the product and recommend the product. Given the overwhelming anecdotal evidence of the effectiveness of e-cigarettes for smoking cessation, formally studying the longer-term effectiveness of these products is a research priority.
Electronic cigarettes have the potential to be a life-saving intervention for millions of smokers. The FDA and the anti-smoking groups need to embrace this product and support the appropriate testing, not remove it abruptly from the market and sentence over a million e-cigarette users to disease and even death by a return to conventional cigarettes.
Wednesday, July 29, 2009
Campaign for Tobacco-Free Kids, Other Anti-Smoking Groups Would Condemn a Million Ex-Smokers to Return to Cigarette Smoking, Causing Countless Deaths
The Campaign for Tobacco-Free Kids has joined a number of other anti-smoking groups in calling for a ban on electronic cigarettes and an immediate removal of these devices from the market. In a press release issued last week, the Campaign wrote: "The U.S. Food and Drug Administration has acted to protect public health from so-called electronic cigarettes by seeking to block importation of these products and, during a press briefing today, informing the public about the potential health risks of these products. ... We look forward to the FDA taking additional action to stop the marketing and sale of these unapproved products. ... Smokers concerned about their health should utilize approved smoking cessation medications and counseling rather than unapproved products. As the World Health Organization has concluded, until electronic cigarette manufacturers have conducted the necessary scientific studies and gone through the appropriate regulatory process, 'WHO does not consider it to be a legitimate therapy for smokers trying to quit.'"
The Rest of the Story
What the Campaign for Tobacco-Free Kids and other anti-smoking groups are saying is that they would rather have one million or more ex-smokers who have successfully quit using electronic cigarettes return to cigarette smoking than continue staying quit by using the e-cigarettes.
Ironically, the precise action that the Campaign and other groups are urging the FDA to take in the name of public health protection would condemn at least one million individuals to return to smoking conventional cigarettes. This would lead to increased morbidity and countless deaths among these individuals, many of whom have experienced a drastic improvement in their health since switching to electronic cigarettes.
For the life of me, I cannot understand why anti-smoking groups would want smokers to return to conventional cigarettes rather than to stay quit with the use of electronic ones, which deliver the nicotine without the more than 10,000 other toxins and high levels of carcinogens found in conventional cigarettes.
While the Campaign is urging electronic cigarette users to switch to nicotine replacement products or other approved drugs - like Chantix, which we know has potentially deadly adverse effects - the reality is that the overwhelming majority of these one million or more users will return to cigarette smoking, as they have found these other methods for smoking cessation to be unsuccessful. In fact, that is precisely the reason why they tried e-cigarettes in the first place.
While nicotine replacement products can address the pharmaceutical aspect of the smoking addiction, they do not address all the other behavioral aspects, such as the role that the act of smoking plays in providing the pleasurable response that smokers experience. The beauty of electronic cigarettes is that they simulate most aspects of the smoking experience. This is why many vapers have found electronic cigarettes to be far more effective than the "approved" smoking cessation drugs.
If electronic cigarettes had not yet been introduced to the U.S. market, it would not be unreasonable to ask that the products go through the regulatory channels required of drugs and devices before being placed on the market. But it's too late. The cat is out of the bag. And the reality is that there are well over one million electronic cigarette users, according to sources within the industry.
It is ludicrous to take the product off the market and force the million or more e-cigarette users to return to cigarette smoking.
In the past few days, I have received countless testimonials from e-cigarette users, thanking me for exposing the rest of the story regarding these products. Here are just a few of them, but they are typical of the many responses I have received. They demonstrate that these products, in the eyes of many users, are far superior to traditional, approved NRT and other smoking cessation products, that the use of these products has led to dramatic health improvements in users, and that forcing these people to return to regular cigarettes would be criminal:
"I just read your response to the recent FDA warning about electronic cigarettes, and I'm writing to express my heartfelt thanks to all of you for your continued efforts to keep these devices available. I smoked for more than 30 years and tried everything to quit (patch, gum, hypnosis, cold turkey). I failed every time. In 2005, I took care of my mother as she died of lung cancer from years of heavy smoking. I remember thinking, "If this doesn't make me quit, nothing will." Well...it didn't make me quit, and every time I lit up, I felt like a doomed failure."
"Five months ago I purchased an e-cigarette, and to my utter astonishment, completely quit tobacco cigarettes within the first week. I have no desire to resume smoking, and my health has improved immensely. I've weaned myself from high- to low-nicotine content and plan to eliminate it entirely over the next couple of months. As you all know, there are thousands of stories just like mine. And with the continued efforts of compassionate souls like you, I'm convinced that thousands can become hundreds of thousands. You are doing great, important work--and you have my sincere gratitude."
"Thank you so much for standing up on behalf of e-cig users like myself. I have been smoke-free for 51 days, thanks to e-cigarettes, after 40 years of being a smoker (2.5 packs per day for the past 10 years or so). Even in such short a time, I can laugh again without breaking into a coughing fit. I can make my bed and mow my lawn without running out of breath. I can wake up in the morning without spending the first hour hacking up crap from my lungs."
"Nevertheless, because of the recent FDA press conference, people who once congratulated me for turning to e-cigs (or who had never even heard of e-cigs prior to the announcement) are now telling me that they are likely to kill me. And they say as much just before stepping outside public arenas to light up a real cigarette."
"Why is the FDA doing this? Why does our government want to kill people? I don't understand."
Well I don't understand either. I certainly don't have an answer to that question.
It is clear from these responses that the FDA's recent action has scared many e-cigarette users and if the FDA takes the anti-smoking groups' advice and follows through with its own threatened actions, it will lead to perhaps more than one million e-cigarette users returning to conventional smoking. How in the world is that possibly an action that is in the interests of protecting the public's health? The only entity whose interests that serves is Big Tobacco, who loses money every time someone uses an e-cigarette.
By the way, for many more testimonials, click here and here.
It is startling to me how electronic cigarette policy is being informed by so much misinformation. Why don't the health groups and authorities want to actually examine the extent of e-cigarette use and talk to a large number of users to assess their experience, before they pull these truly life-altering devices from the market?
Perhaps the best example of the kind of misinformation out there is a Huffington Post column by Karen Stabiner which supports a ban on electronic cigarettes on the basis that the tobacco industry - which manufactures and markets these products - cannot be trusted.
Stabiner asserts that: "the companies that push nicotine [the tobacco companies] make it so easy for me to vent; over 40 years after the first health warnings, they're still looking for ways to build their customer base, still dismissing the latest research, still pursuing my lovely, clean-breathing daughter, all of her friends, and all of their younger siblings. The latest gimmick is the electronic cigarette. Yes, the bipolar tobacco industry, which pretends it wants you to stop smoking even as it invents new ways to keep people hooked, has invented a plastic tube that looks like a cigarette, delivers nicotine like a cigarette, and runs on a battery--supposedly to keep the user from inhaling some less life-affirming ingredients. ... I have no sympathy for an industry that exists primarily because it's wealthy enough to take on and trounce all comers. ... Go make some good news for yourself; log on to the FDA site and tell them just how you feel about a business that kills not only its customers but unlucky second-handers who spend too much time with those customers."
The entire premise of the column is that electronic cigarettes are the newest ploy by Big Tobacco to get people hooked to its products. The truth, of course, is that electronic cigarettes are not produced or sold by tobacco companies and that they in fact represent a huge threat to Big Tobacco. As Emily Litella would say: "Never mind."
The reality is that electronic cigarettes have been on the market for about three years and we don not have reports of adverse effects (in contrast with Chantix, where we have reports of thousands of adverse effects, including hundreds of deaths, but the FDA still approves the product). As Jacob Sullum pointed out in a Hit & Run column, the FDA press conference last week urged people to call in with complaints about the adverse effects of e-cigarettes because the FDA doesn't have any after three years of widespread use of the product, but is desperate to generate some evidence to support its pre-determined decision to ban the product.
Sullum writes: "The statement closes by soliciting consumer complaints about "serious adverse events (side effects) or product quality problems with the use of e-cigarettes," possibly because the FDA does not have any yet and needs them to justify removing the product from the market. It seems clear that the FDA already has decided to ban e-cigarettes and is now seeking evidence to back up that decision. This approach, which replaces science and consumer protection with puritanism and bureaucratic pigheadedness, sacrifices the interests—and possibly the lives—of smokers who could dramatically reduce their disease risks by switching to e-cigarettes."
Anti-smoking groups, and the FDA itself, has displayed a complete lack of perspective in dealing with the issue of electronic cigarettes. They would have us believe that electronic cigarettes are the true threat to the public's health, when the overwhelming evidence demonstrates that e-cigarettes are not the threat, the real ones are.
An electronic cigarette user summed up the implications of the FDA report better than anything I have seen, as follows: "The problem with the FDA's statements are not that they contain untruths, but that they lack perspective on the truths they uncovered. The FDA didn't uncover danger; it found potentially dangerous substances. There's a big difference. Viewed in proper perspective, the FDA's findings do not show a health hazard in e-liquid any greater than any approved NRT product. That's the point we need to hammer home, as some have begun doing."
Perhaps Dr. Murray Laugesan said it best, as quoted in an article on a New Zealand television web site: "The carcinogens that we have found have been in very, very small quantity, just above the level of detection. ... They're not going to die from an e-cigarette. But they could die tomorrow from a heart attack due to their smoking."
That the Campaign for Tobacco-Free Kids and other supposed "health" groups would prefer that these individuals die from heart attacks due to smoking while we wait the 8 years or so that it takes to conduct the tests necessary to gain FDA approval for new devices than that they stay off the most toxic conventional cigarettes is a travesty.
The Rest of the Story
What the Campaign for Tobacco-Free Kids and other anti-smoking groups are saying is that they would rather have one million or more ex-smokers who have successfully quit using electronic cigarettes return to cigarette smoking than continue staying quit by using the e-cigarettes.
Ironically, the precise action that the Campaign and other groups are urging the FDA to take in the name of public health protection would condemn at least one million individuals to return to smoking conventional cigarettes. This would lead to increased morbidity and countless deaths among these individuals, many of whom have experienced a drastic improvement in their health since switching to electronic cigarettes.
For the life of me, I cannot understand why anti-smoking groups would want smokers to return to conventional cigarettes rather than to stay quit with the use of electronic ones, which deliver the nicotine without the more than 10,000 other toxins and high levels of carcinogens found in conventional cigarettes.
While the Campaign is urging electronic cigarette users to switch to nicotine replacement products or other approved drugs - like Chantix, which we know has potentially deadly adverse effects - the reality is that the overwhelming majority of these one million or more users will return to cigarette smoking, as they have found these other methods for smoking cessation to be unsuccessful. In fact, that is precisely the reason why they tried e-cigarettes in the first place.
While nicotine replacement products can address the pharmaceutical aspect of the smoking addiction, they do not address all the other behavioral aspects, such as the role that the act of smoking plays in providing the pleasurable response that smokers experience. The beauty of electronic cigarettes is that they simulate most aspects of the smoking experience. This is why many vapers have found electronic cigarettes to be far more effective than the "approved" smoking cessation drugs.
If electronic cigarettes had not yet been introduced to the U.S. market, it would not be unreasonable to ask that the products go through the regulatory channels required of drugs and devices before being placed on the market. But it's too late. The cat is out of the bag. And the reality is that there are well over one million electronic cigarette users, according to sources within the industry.
It is ludicrous to take the product off the market and force the million or more e-cigarette users to return to cigarette smoking.
In the past few days, I have received countless testimonials from e-cigarette users, thanking me for exposing the rest of the story regarding these products. Here are just a few of them, but they are typical of the many responses I have received. They demonstrate that these products, in the eyes of many users, are far superior to traditional, approved NRT and other smoking cessation products, that the use of these products has led to dramatic health improvements in users, and that forcing these people to return to regular cigarettes would be criminal:
"I just read your response to the recent FDA warning about electronic cigarettes, and I'm writing to express my heartfelt thanks to all of you for your continued efforts to keep these devices available. I smoked for more than 30 years and tried everything to quit (patch, gum, hypnosis, cold turkey). I failed every time. In 2005, I took care of my mother as she died of lung cancer from years of heavy smoking. I remember thinking, "If this doesn't make me quit, nothing will." Well...it didn't make me quit, and every time I lit up, I felt like a doomed failure."
"Five months ago I purchased an e-cigarette, and to my utter astonishment, completely quit tobacco cigarettes within the first week. I have no desire to resume smoking, and my health has improved immensely. I've weaned myself from high- to low-nicotine content and plan to eliminate it entirely over the next couple of months. As you all know, there are thousands of stories just like mine. And with the continued efforts of compassionate souls like you, I'm convinced that thousands can become hundreds of thousands. You are doing great, important work--and you have my sincere gratitude."
"Thank you so much for standing up on behalf of e-cig users like myself. I have been smoke-free for 51 days, thanks to e-cigarettes, after 40 years of being a smoker (2.5 packs per day for the past 10 years or so). Even in such short a time, I can laugh again without breaking into a coughing fit. I can make my bed and mow my lawn without running out of breath. I can wake up in the morning without spending the first hour hacking up crap from my lungs."
"Nevertheless, because of the recent FDA press conference, people who once congratulated me for turning to e-cigs (or who had never even heard of e-cigs prior to the announcement) are now telling me that they are likely to kill me. And they say as much just before stepping outside public arenas to light up a real cigarette."
"Why is the FDA doing this? Why does our government want to kill people? I don't understand."
Well I don't understand either. I certainly don't have an answer to that question.
It is clear from these responses that the FDA's recent action has scared many e-cigarette users and if the FDA takes the anti-smoking groups' advice and follows through with its own threatened actions, it will lead to perhaps more than one million e-cigarette users returning to conventional smoking. How in the world is that possibly an action that is in the interests of protecting the public's health? The only entity whose interests that serves is Big Tobacco, who loses money every time someone uses an e-cigarette.
By the way, for many more testimonials, click here and here.
It is startling to me how electronic cigarette policy is being informed by so much misinformation. Why don't the health groups and authorities want to actually examine the extent of e-cigarette use and talk to a large number of users to assess their experience, before they pull these truly life-altering devices from the market?
Perhaps the best example of the kind of misinformation out there is a Huffington Post column by Karen Stabiner which supports a ban on electronic cigarettes on the basis that the tobacco industry - which manufactures and markets these products - cannot be trusted.
Stabiner asserts that: "the companies that push nicotine [the tobacco companies] make it so easy for me to vent; over 40 years after the first health warnings, they're still looking for ways to build their customer base, still dismissing the latest research, still pursuing my lovely, clean-breathing daughter, all of her friends, and all of their younger siblings. The latest gimmick is the electronic cigarette. Yes, the bipolar tobacco industry, which pretends it wants you to stop smoking even as it invents new ways to keep people hooked, has invented a plastic tube that looks like a cigarette, delivers nicotine like a cigarette, and runs on a battery--supposedly to keep the user from inhaling some less life-affirming ingredients. ... I have no sympathy for an industry that exists primarily because it's wealthy enough to take on and trounce all comers. ... Go make some good news for yourself; log on to the FDA site and tell them just how you feel about a business that kills not only its customers but unlucky second-handers who spend too much time with those customers."
The entire premise of the column is that electronic cigarettes are the newest ploy by Big Tobacco to get people hooked to its products. The truth, of course, is that electronic cigarettes are not produced or sold by tobacco companies and that they in fact represent a huge threat to Big Tobacco. As Emily Litella would say: "Never mind."
The reality is that electronic cigarettes have been on the market for about three years and we don not have reports of adverse effects (in contrast with Chantix, where we have reports of thousands of adverse effects, including hundreds of deaths, but the FDA still approves the product). As Jacob Sullum pointed out in a Hit & Run column, the FDA press conference last week urged people to call in with complaints about the adverse effects of e-cigarettes because the FDA doesn't have any after three years of widespread use of the product, but is desperate to generate some evidence to support its pre-determined decision to ban the product.
Sullum writes: "The statement closes by soliciting consumer complaints about "serious adverse events (side effects) or product quality problems with the use of e-cigarettes," possibly because the FDA does not have any yet and needs them to justify removing the product from the market. It seems clear that the FDA already has decided to ban e-cigarettes and is now seeking evidence to back up that decision. This approach, which replaces science and consumer protection with puritanism and bureaucratic pigheadedness, sacrifices the interests—and possibly the lives—of smokers who could dramatically reduce their disease risks by switching to e-cigarettes."
Anti-smoking groups, and the FDA itself, has displayed a complete lack of perspective in dealing with the issue of electronic cigarettes. They would have us believe that electronic cigarettes are the true threat to the public's health, when the overwhelming evidence demonstrates that e-cigarettes are not the threat, the real ones are.
An electronic cigarette user summed up the implications of the FDA report better than anything I have seen, as follows: "The problem with the FDA's statements are not that they contain untruths, but that they lack perspective on the truths they uncovered. The FDA didn't uncover danger; it found potentially dangerous substances. There's a big difference. Viewed in proper perspective, the FDA's findings do not show a health hazard in e-liquid any greater than any approved NRT product. That's the point we need to hammer home, as some have begun doing."
Perhaps Dr. Murray Laugesan said it best, as quoted in an article on a New Zealand television web site: "The carcinogens that we have found have been in very, very small quantity, just above the level of detection. ... They're not going to die from an e-cigarette. But they could die tomorrow from a heart attack due to their smoking."
That the Campaign for Tobacco-Free Kids and other supposed "health" groups would prefer that these individuals die from heart attacks due to smoking while we wait the 8 years or so that it takes to conduct the tests necessary to gain FDA approval for new devices than that they stay off the most toxic conventional cigarettes is a travesty.
Tuesday, July 28, 2009
Prominent Tobacco Researchers Expose Double Standard in FDA's Study of Electronic Cigarettes and Challenge FDA's Alarmist Attitude Toward the Devices
The press release can be found here.
I have copied it below, as well:
I have copied it below, as well:
| Prominent Public Health Physicians and Tobacco Researchers Expose Double Standard in the FDA's Recent Study of Electronic Cigarettes and Challenge the FDA's Alarmist Attitude Toward the Devices Contact: Thomas R. Kiklas, Director of Media, inLife LLC, 949-250-9600 ext 108, tkiklas@myinlife.com BOSTON, July 27 /Standard Newswire/ -- The FDA recently went public with misleading information about the safety of electronic cigarettes and the marketing of the devices, not only using its clout but recruiting other prominent organizations to demonize a product that has great public health benefit potential. A group of prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville, challenge the FDA to provide the full quantitative data of the study upon which the FDA has based its warning against electronic cigarettes. They are concerned that the FDA's disingenuous targeting of electronic cigarettes through a biased presentation of the scientific data has had significant negative impact upon the public perception of electronic cigarettes, when the best available evidence suggests that these have shown that the devices offer great potential to reduce serious health issues among traditional tobacco smokers. In a July 22 news release, the FDA cited the detectable presence of carcinogens and "toxic chemicals" in a "small sample" of electronic cigarette cartridges as reason for alarm, singling out nitrosamines as particularly toxic. What the FDA fails to inform the public is that detectable amounts of carcinogens are also present in nicotine replacement products such as NicoDerm CQ and Nicorette gum, both approved by the FDA, and nitrosamines that can be also found in food items such bacon and beer. This double standard and alarmist attitude has had the significant and unfortunate effect of inducing hysteria among the public, discouraging tobacco smokers from using a product which is thought to be a significantly safer alternative to traditional tobacco. Regrettably, the FDA has used biased reporting of this small and inconclusive study, the complete results of which have not been made public, to secure the vocal support of groups such as the American Academy of Pediatrics Tobacco Consortium, the Institute for Global Health, and the American Lung Association in their attack on electronic cigarettes. These researchers argue that it is absurd to consider taking electronic cigarettes off the market when it is the conventional ones which have been shown to be killing people. Further, the electronic cigarette community calls for accurate and fair reporting relative to the findings and statements of prominent medical professionals in favor of this new and important technology and challenges the media to tell the other side of the story. "The FDA's laboratory findings actually indicate that electronic cigarettes are much, much safer than conventional cigarettes," says Dr. Michael Siegel. "The traces of carcinogens present are also present in nicotine replacement products. The FDA and the anti-smoking groups have fallen into a huge analytical trap as they have failed to ask the appropriate question. The question they are asking is: 'Are electronic cigarettes safe?' That is not the right question. The right question is: 'Are electronic cigarettes much safer than traditional ones?'" Dr. Rodu states, "The FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and the methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years. These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes." Dr. Joel Nitzkin speaking as individual states, "The newly adopted FDA/Tobacco legislation will give full FDA approval to currently marketed conventional cigarettes. The new law encourages cigarette companies to produce new "reduced exposure" cigarettes to be marketed as reduced exposure products, with no scientific evidence that such reductions in exposure will reduce risk of future tobacco related illness and death. In the context of these provisions of the newly adopted FDA/Tobacco bill -- FDA should be encouraging, not maligning the manufacture and sale of electronic cigarettes, and working with manufacturers to assure the highest possible quality control." For more information and interviews, contact: Michael Siegel, MD, MPH Professor Department of Community Health Sciences Boston University School of Public Health 617-638-5167 Email: mbsiegel@bu.edu Joel L. Nitzkin, MD, MPH, DPA Chair AAPHP Tobacco Control Task Force Phone: 504 899 7893 or 800 598 2561 Fax: 504 899 7557 Brad Rodu Professor of Medicine Endowed Chair, Tobacco Harm Reduction Research University of Louisville Phone: 502-561-7273 Email: brad.rodu@louisville.edu Thomas R. Kiklas Director of Media inLife LLC Phone: 949-250-9600 x108 Email: tkiklas@myinlife.com |
Monday, July 27, 2009
Potent Carcinogens (Tobacco-Specific Nitrosamines) Found in Saliva of Nicotine Gum Users; When Will FDA Take Enforcement Action Against Nicorette?
An article in the journal Food and Chemical Toxicology has revealed that tobacco-specific nitrosamines are present in the saliva of nicotine gum users, indicating that actual exposure to carcinogens results from the use of Nicorette gum (see: Osterdahl BG. The migration of tobacco-specific nitrosamines into the saliva of chewers of nicotine-containing chewing gum. Food and Chemical Toxicology 1990; 28:619-622).
The article reported three major findings:
1. "All the saliva samples obtained during Nicorette chewing contained NNN and NAT/NAB at levels ranging from 0.42 to 19 ng/g and from 1.3 to 46 ng/g, respectively."
2. "All Nicorette samples contained NNN and NAT/NAB, at levels ranging from 38 to 180 ng/g
and from 29 to 260 ng/g, respectively, NNK was found in two samples at levels of up to 3.0 ng/g."
3. "The levels of TSNA found in the saliva of Nicorette chewers seem to be higher than the few values of TSNA reported in the saliva of smokers."
Thus, this study found that carcinogens were present in nicotine gum, that gum users are exposed to these carcinogens, that these carcinogens are present in the saliva of gum users, and that the level of these carcinogens in the saliva of Nicorette users is higher than in the saliva of cigarette smokers. The latter finding is not surprising since the gum is being chewed, while tobacco cigarette smoke is inhaled.
Where are the carcinogens coming from? The article hypothesized that "the presence of NAT/NAB could be due to contamination of the nicotine extracted from tobacco leaves."
The article concluded as follows: "The saliva of Nicorette chewers contains carcinogenic TSNA. It is not possible at present to estimate reliably the carcinogenic risk for man of exposure to such very small amounts of nitrosamines. It is, however, desirable to reduce the exposure to these compounds whenever possible. It should be possible to reduce the levels of TSNA in the nicotine-containing chewing gum to a minimum by using a more appropriate method to extract nicotine from tobacco leaves."
The Rest of the Story
This research demonstrates that a slanted presentation of laboratory data on the detection of carcinogens in nicotine delivering products can lead to completely erroneous public health conclusions.
In the case of nicotine gum, there are clearly detectable levels of carcinogens present in the product and users are exposed to these carcinogens, which are measurable in their saliva.
In the case of electronic cigarettes, there are also clearly detectable levels of carcinogens present in the product. Unlike with nicotine gum, it has yet to be determined the extent to which users are exposed to these carcinogens and whether they are detectable in body fluid samples of users.
The explanation for this finding of trace levels of carcinogens - in both cases - is that the nicotine is extracted from tobacco and there is contamination. It is difficult to extract the nicotine in a 100% pure form.
But unlike in this scientific article, the FDA failed to inform the public of exactly what was going on. The Agency withheld the truth from consumers. And it appears that this was done intentionally to try to scare electronic cigarette users into thinking that there are high levels of carcinogens in e-cigarettes and that they should therefore stop using them because of the high risk of cancer.
Of course, the FDA is not going to hold a similar press conference to announce that there are detectable levels of carcinogens in the saliva of nicotine gum users. Or that tobacco-specific nitrosamines have been identified in a wide variety of nicotine replacement products.
The Agency is apparently only going to present a slanted version of the facts when it fits its agenda.
If I really wanted to, I could scare nicotine gum users throughout the country by holding a press conference to announce that nicotine gum contains carcinogens, that we have detected these carcinogens in the saliva of gum users, and that the level of TSNA's in the saliva of nicotine gum users is higher than that in the saliva of cigarette smokers.
This would certainly scare many nicotine gum users, and many of them would probably be scared enough to lay off the gum and return to cigarette smoking.
If I did this, I would have to turn myself in for medical malpractice, because that's the label that I think fits. It would be criminal of me to use a misleading presentation of the scientific data to try to scare thousands of nicotine gum users into returning to cigarette smoking. Realistically, that is exactly what I would be doing.
Sadly, I believe that this is exactly what the FDA has done with respect to electronic cigarettes. I believe the Agency has used a misleading presentation of very similar scientific data to try to scare thousands of electronic cigarette users into returning to cigarette smoking.
And for the life of me, I just can't figure out why the FDA would want to do that. Why would they want perhaps hundreds of thousands of electronic cigarette users to return to cigarette smoking? It just baffles my mind and I can't figure out why they would want such a thing.
You can talk all day about how electronic cigarettes are a nicotine delivery device and they need to be regulated by the FDA and there's a risk that children might poison themselves and kids might be enticed to start smoking them, and on and on. But how does any of that justify taking the product off the market or scaring e-cigarette users into returning to conventional cigarette smoking?
It's not clear that tobacco control groups are capable of understanding a simple harm reduction argument. Or at least not when it comes to electronic cigarettes, a product that is not produced by either the tobacco or pharmaceutical industries.
However, when it comes to nicotine replacment therapy, anti-smoking groups seem to understand exactly what harm reduction means. For example, when it was reported that nicotine replacement products might pose some cancer risk to users, the UK anti-smoking group Action on Smoking and Health urged NRT users not to abandon these products and under no circumstances to return to cigarette smoking, stating: "It is important to keep a sense of proportion. Taking off the nicotine patches is much more likely to kill you than keeping them on."
But when it comes to electronic cigarettes, it seems that the same harm reduction argument no longer applies: Dr. Jonathan Samet, director of the University of Southern California's Institute for Global Health, was quoted in a Fort-Worth Star-Telegram article as stating: "I think the bottom line here is simple. These are devices of delivering nicotine through unknown magnitude into the body with no proven benefit for cessation and some indication that there may be risks."
There is certainly some indication that there may be risks of using NRT products. But Dr. Samet and other anti-smoking researchers are not calling for these products to be taken off the market until we know for sure what those risks are. Harm reduction, I guess, only applies to products made by corporations that funnel huge amounts of money into anti-smoking coffers.
Ironically, two individuals showing the greatest understanding of the issue are not from the tobacco control movement, FDA, or any public health group. They are members of the public - presumably electronic cigarette users - who truly appreciate exactly what is at stake here. On an electronic cigarette discussion forum, one individual commented:
"Pisses me off to no end that the FDA is now changing people's minds about how safe it is for the vaporer and for those around them. Many potential analog quitters will now not be making the switch to e-cigs....How sad and frustrating...."
To which another individual responded: "You know, this is a very good point. FDA has incredible power to disseminate information to the media. If they present skewed findings it is not the same as when a manufacturer does it -- the general public views FDA as "neutral" and will take FDA comments to be the independent truth. If FDA statements turn analog smokers away from PVs [electronic cigarettes], the FDA would be in a very difficult spot when the truth comes out."
These are insightful comments, and they are exactly on the mark.
Well the truth has now come out and the FDA is indeed in a very difficult spot. How can the Agency possibly explain its desire to have perhaps hundreds of thousands of electronic cigarette users returning to the most highly toxic consumer product out there -- conventional cigarettes? How can that possibly be a good thing for the public's health?
The article reported three major findings:
1. "All the saliva samples obtained during Nicorette chewing contained NNN and NAT/NAB at levels ranging from 0.42 to 19 ng/g and from 1.3 to 46 ng/g, respectively."
2. "All Nicorette samples contained NNN and NAT/NAB, at levels ranging from 38 to 180 ng/g
and from 29 to 260 ng/g, respectively, NNK was found in two samples at levels of up to 3.0 ng/g."
3. "The levels of TSNA found in the saliva of Nicorette chewers seem to be higher than the few values of TSNA reported in the saliva of smokers."
Thus, this study found that carcinogens were present in nicotine gum, that gum users are exposed to these carcinogens, that these carcinogens are present in the saliva of gum users, and that the level of these carcinogens in the saliva of Nicorette users is higher than in the saliva of cigarette smokers. The latter finding is not surprising since the gum is being chewed, while tobacco cigarette smoke is inhaled.
Where are the carcinogens coming from? The article hypothesized that "the presence of NAT/NAB could be due to contamination of the nicotine extracted from tobacco leaves."
The article concluded as follows: "The saliva of Nicorette chewers contains carcinogenic TSNA. It is not possible at present to estimate reliably the carcinogenic risk for man of exposure to such very small amounts of nitrosamines. It is, however, desirable to reduce the exposure to these compounds whenever possible. It should be possible to reduce the levels of TSNA in the nicotine-containing chewing gum to a minimum by using a more appropriate method to extract nicotine from tobacco leaves."
The Rest of the Story
This research demonstrates that a slanted presentation of laboratory data on the detection of carcinogens in nicotine delivering products can lead to completely erroneous public health conclusions.
In the case of nicotine gum, there are clearly detectable levels of carcinogens present in the product and users are exposed to these carcinogens, which are measurable in their saliva.
In the case of electronic cigarettes, there are also clearly detectable levels of carcinogens present in the product. Unlike with nicotine gum, it has yet to be determined the extent to which users are exposed to these carcinogens and whether they are detectable in body fluid samples of users.
The explanation for this finding of trace levels of carcinogens - in both cases - is that the nicotine is extracted from tobacco and there is contamination. It is difficult to extract the nicotine in a 100% pure form.
But unlike in this scientific article, the FDA failed to inform the public of exactly what was going on. The Agency withheld the truth from consumers. And it appears that this was done intentionally to try to scare electronic cigarette users into thinking that there are high levels of carcinogens in e-cigarettes and that they should therefore stop using them because of the high risk of cancer.
Of course, the FDA is not going to hold a similar press conference to announce that there are detectable levels of carcinogens in the saliva of nicotine gum users. Or that tobacco-specific nitrosamines have been identified in a wide variety of nicotine replacement products.
The Agency is apparently only going to present a slanted version of the facts when it fits its agenda.
If I really wanted to, I could scare nicotine gum users throughout the country by holding a press conference to announce that nicotine gum contains carcinogens, that we have detected these carcinogens in the saliva of gum users, and that the level of TSNA's in the saliva of nicotine gum users is higher than that in the saliva of cigarette smokers.
This would certainly scare many nicotine gum users, and many of them would probably be scared enough to lay off the gum and return to cigarette smoking.
If I did this, I would have to turn myself in for medical malpractice, because that's the label that I think fits. It would be criminal of me to use a misleading presentation of the scientific data to try to scare thousands of nicotine gum users into returning to cigarette smoking. Realistically, that is exactly what I would be doing.
Sadly, I believe that this is exactly what the FDA has done with respect to electronic cigarettes. I believe the Agency has used a misleading presentation of very similar scientific data to try to scare thousands of electronic cigarette users into returning to cigarette smoking.
And for the life of me, I just can't figure out why the FDA would want to do that. Why would they want perhaps hundreds of thousands of electronic cigarette users to return to cigarette smoking? It just baffles my mind and I can't figure out why they would want such a thing.
You can talk all day about how electronic cigarettes are a nicotine delivery device and they need to be regulated by the FDA and there's a risk that children might poison themselves and kids might be enticed to start smoking them, and on and on. But how does any of that justify taking the product off the market or scaring e-cigarette users into returning to conventional cigarette smoking?
It's not clear that tobacco control groups are capable of understanding a simple harm reduction argument. Or at least not when it comes to electronic cigarettes, a product that is not produced by either the tobacco or pharmaceutical industries.
However, when it comes to nicotine replacment therapy, anti-smoking groups seem to understand exactly what harm reduction means. For example, when it was reported that nicotine replacement products might pose some cancer risk to users, the UK anti-smoking group Action on Smoking and Health urged NRT users not to abandon these products and under no circumstances to return to cigarette smoking, stating: "It is important to keep a sense of proportion. Taking off the nicotine patches is much more likely to kill you than keeping them on."
But when it comes to electronic cigarettes, it seems that the same harm reduction argument no longer applies: Dr. Jonathan Samet, director of the University of Southern California's Institute for Global Health, was quoted in a Fort-Worth Star-Telegram article as stating: "I think the bottom line here is simple. These are devices of delivering nicotine through unknown magnitude into the body with no proven benefit for cessation and some indication that there may be risks."
There is certainly some indication that there may be risks of using NRT products. But Dr. Samet and other anti-smoking researchers are not calling for these products to be taken off the market until we know for sure what those risks are. Harm reduction, I guess, only applies to products made by corporations that funnel huge amounts of money into anti-smoking coffers.
Ironically, two individuals showing the greatest understanding of the issue are not from the tobacco control movement, FDA, or any public health group. They are members of the public - presumably electronic cigarette users - who truly appreciate exactly what is at stake here. On an electronic cigarette discussion forum, one individual commented:
"Pisses me off to no end that the FDA is now changing people's minds about how safe it is for the vaporer and for those around them. Many potential analog quitters will now not be making the switch to e-cigs....How sad and frustrating...."
To which another individual responded: "You know, this is a very good point. FDA has incredible power to disseminate information to the media. If they present skewed findings it is not the same as when a manufacturer does it -- the general public views FDA as "neutral" and will take FDA comments to be the independent truth. If FDA statements turn analog smokers away from PVs [electronic cigarettes], the FDA would be in a very difficult spot when the truth comes out."
These are insightful comments, and they are exactly on the mark.
Well the truth has now come out and the FDA is indeed in a very difficult spot. How can the Agency possibly explain its desire to have perhaps hundreds of thousands of electronic cigarette users returning to the most highly toxic consumer product out there -- conventional cigarettes? How can that possibly be a good thing for the public's health?
Friday, July 24, 2009
Disingenuousness of the FDA's Press Conference is Concerning; FDA and Anti-Smoking Groups are Committing Medical Malpractice on a Massive Scale
To me, the most alarming concern regarding the FDA's press conference on electronic cigarettes was how unscientific and disingenuous the Agency was in its presentation of laboratory findings on electronic cigarettes. The Agency struck an alarmist tone, acting as if its finding of detectable levels of tobacco-specific nitrosamines in electronic cigarettes demonstrated that these products are toxic and unsuitable for use. The clear message to e-cigarette users was that they should stop using these toxic products and go back to regular cigarettes.
Clearly, the FDA's message came across loud and clear. Vapers (e-cigarette users) throughout the country were scared by the announcement -- so scared that they are seriously thinking that they should return to regular cigarettes. The FDA-created hysteria is typified by this comment from a vaper: "I've got all the people that I turned on to e-cigs calling me up scared out of their minds that they are inhaling worse chemicals than were in their cigarettes!"
And it's not just the vaping community which has lost its sense of perspective due to the FDA's hysterical and unscientific presentation of the facts. Physicians have also lost any sense of perspective. Take this pulmonologist who was quoted in the Los Angeles Times as urging vapers to go back to analog (regular) cigarettes immediately:
"'Electronic cigarettes should be absolutely avoided because they clearly have toxic elements,' said Dr. Jonathan Whiteson, a pulmonologist at New York University Langone Medical Center. 'It is proven now that electronic cigarettes contain toxic elements. Electronic cigarettes play no role in smoking cessation and don't add to a healthier lifestyle.'"
The Rest of the Story
The rest of the story is that there was nothing new or unexpected about the FDA's major findings, we have known for a long time that e-cigarettes contain traces of nitrosamines, and it would in fact be shockingly newsworthy if nitrosamines were not detected in e-cigarette cartridges. The FDA - acting like an advocacy group rather than a scientific government agency - conveniently failed to mention to the media and the public that nicotine replacement products - such as gums, inhalers, and patches, also contain traces of tobacco-specific nitrosamines (i.e., carcinogens). The nicotine is derived from tobacco, so even "pure" and "clean" nicotine formulations contain traces of carcinogens. The analytic methods used to detect the nitrosamines are so sensitive that they pick up these traces of carcinogens retained in the nicotine formulations.
Had the FDA acted in an objective manner - it would have had to also urge the public not to use nicotine replacement products, since they have carcinogens in them. The American Lung Association - which called for e-cigarettes to be banned since they have carcinogens in them - should also have called for the immediate removal of nicotine replacement products from the market.
Clearly, the FDA was presenting a very biased, distorted, and incomplete version of the facts. The laboratory data on nitrosamines was essentially meaningless. In other words, the entire press conference was really more of a public relations stunt than a meaningful release of important scientific information that changes the way in which consumer products should be used. This is why I argue that the FDA acted more like an advocacy group than a scientific federal agency.
But that's just the first half of the rest of the story.
The Rest of the Story
The rest of the story is that not only did the FDA act like an advocacy group, but they and the anti-smoking groups actually acted like pro-smoking advocacy groups. They did the work of Big Tobacco on Thursday, and the beauty of it all is that the tobacco companies didn't have to say a word.
There is no bigger favor that anti-smoking groups or the FDA could do for Big Tobacco than to urge consumers not to use electronic cigarettes. These products represent perhaps the greatest threat to domestic cigarette profits. There are well over 100,000 users of e-cigarettes and most of these users represent former cigarette smokers. Most of the rest are individuals who have greatly cut down on the amount that they smoke. So dollars spent on e-cigarettes are essentially dollars not spent on cigarettes. The higher electronic cigarette consumption is, the lower analog cigarette consumption is.
What the FDA and the anti-smoking groups seemingly fail to realize is that by urging e-cigarette users to stop vaping, they are essentially instructing these individuals to return to cigarette smoking.
For the FDA officials and anti-smoking groups reading this, let me highlight this point: What the FDA and the anti-smoking groups seemingly fail to realize is that by urging e-cigarette users to stop vaping, they are essentially instructing these individuals to return to cigarette smoking.
Why would the FDA and anti-smoking groups want to create an additional 100,000-plus smokers overnight? How is it possibly beneficial for the public's health to have well over 100,000 people who were managing miraculously to keep off of cigarettes to return to cigarette smoking?
There are thousands of testimonials from vapers who had previously been smoking two, there, four packs of cigarettes a day. Many of these smokers had tried NRT to no avail. Many were smokers who had smoked for 20 to 30 years and been unable to quit. Suddenly, they have found a product that enables them to keep off of cigarettes. Or at least to substantially cut down on the amount that they smoke. Many of these vapers testify that their health has improved considerably. Their doctors have expressed amazement at how clear their lungs sound.
Now they have to go back to their doctors and tell them: "Sorry, doc. I had to return to smoking. The FDA and the anti-smoking groups don't want me to be using a relatively clean nicotine-delivery product that has successfully removed most, if not all, of the toxic chemicals and carcinogens that are present in conventional cigarettes. On the FDA's advice, I'm back to my Marlboros."
That's the absurdity of this entire situation: The FDA and the anti-smoking groups would rather that these 100,000 plus individuals smoke Marlboro than use the demonstrably much safer electronic cigarette.
And what is the supposed rationale for harming the health of so many thousands of people by forcing them to go back to the most toxic cigarettes?
Merely that we don't know for sure the definitive safety profile of e-cigarettes.
To which I say: So what? Anyone with a basic familiarity with even high school science realizes that electronic cigarettes are much, much safer than analog ones. A product that delivers nicotine, traces of carcinogens, and even diethylene glycol is obviously much safer than a product which delivers nicotine, huge levels of carcinogens, diethylene glycol, forty other carcinogens, and 10,000 other chemicals and toxins.
Any prudent vaper would draw the logical conclusion that despite a lack of long-term studies on e-cigarettes, it is wiser - from a health perspective - to vape than it is to smoke.
Let's look at it this way: if it was my own family member who we were talking about, I would much rather that the person use electronic cigarettes than return to conventional smoking. For me to instruct the person to go back to regular smoking would be - in my mind - medical malpractice.
Essentially, then, what the FDA and anti-smoking groups are doing is committing medical malpractice on a massive scale: on a population basis.
They are essentially condemning 100,000-plus consumers to a return to the most deadly known consumer product. So many of these individuals have reported a tremendous improvement in their health since switching to electronic cigarettes.
If you are going to undermine this substantial type of health improvement, you had better have a darn good reason. The FDA's carefully staged theatrical production about how e-cigarette cartridges contain traces of carcinogens doesn't cut it. Neither does the hysteria about how kids are going to start vaping left and right, how kids are going to be poisoned by drinking the nicotine cartridges, and how everyone is going to start smoking analog cigarettes because they see the electronic ones.
You see, the FDA and the anti-smoking groups have fallen into a huge analytical trap: they have failed to ask the appropriate question. The question they are asking is: "Are electronic cigarettes safe?" That is not the right question. The right question is: "Are electronic cigarettes much safer than analog ones?"
The FDA and anti-smoking groups are comparing electronic cigarettes to a solution of spring-fresh Maine mountain stream water. What they need to compare electronic cigarettes to is something known as a Marlboro cigarette.
You see, the real threat to our children's health is not electronic cigarettes. It's the damn real ones.
What kids are smoking are not NJoys, InLifes, and Blu's. Kids are smoking Marlboros, Newports, and Camels.
The FDA and the anti-smoking groups damn well better start looking at the actual world around them rather than the ideological fantasy world in which they are living. People are dying and this is no joke. They can joke all they want about the traces of carcinogens in e-cigarettes. But those aren't what are killling 400,000 people a year. I'll say it again: it's the damn real ones.
Clearly, the FDA's message came across loud and clear. Vapers (e-cigarette users) throughout the country were scared by the announcement -- so scared that they are seriously thinking that they should return to regular cigarettes. The FDA-created hysteria is typified by this comment from a vaper: "I've got all the people that I turned on to e-cigs calling me up scared out of their minds that they are inhaling worse chemicals than were in their cigarettes!"
And it's not just the vaping community which has lost its sense of perspective due to the FDA's hysterical and unscientific presentation of the facts. Physicians have also lost any sense of perspective. Take this pulmonologist who was quoted in the Los Angeles Times as urging vapers to go back to analog (regular) cigarettes immediately:
"'Electronic cigarettes should be absolutely avoided because they clearly have toxic elements,' said Dr. Jonathan Whiteson, a pulmonologist at New York University Langone Medical Center. 'It is proven now that electronic cigarettes contain toxic elements. Electronic cigarettes play no role in smoking cessation and don't add to a healthier lifestyle.'"
The Rest of the Story
The rest of the story is that there was nothing new or unexpected about the FDA's major findings, we have known for a long time that e-cigarettes contain traces of nitrosamines, and it would in fact be shockingly newsworthy if nitrosamines were not detected in e-cigarette cartridges. The FDA - acting like an advocacy group rather than a scientific government agency - conveniently failed to mention to the media and the public that nicotine replacement products - such as gums, inhalers, and patches, also contain traces of tobacco-specific nitrosamines (i.e., carcinogens). The nicotine is derived from tobacco, so even "pure" and "clean" nicotine formulations contain traces of carcinogens. The analytic methods used to detect the nitrosamines are so sensitive that they pick up these traces of carcinogens retained in the nicotine formulations.
Had the FDA acted in an objective manner - it would have had to also urge the public not to use nicotine replacement products, since they have carcinogens in them. The American Lung Association - which called for e-cigarettes to be banned since they have carcinogens in them - should also have called for the immediate removal of nicotine replacement products from the market.
Clearly, the FDA was presenting a very biased, distorted, and incomplete version of the facts. The laboratory data on nitrosamines was essentially meaningless. In other words, the entire press conference was really more of a public relations stunt than a meaningful release of important scientific information that changes the way in which consumer products should be used. This is why I argue that the FDA acted more like an advocacy group than a scientific federal agency.
But that's just the first half of the rest of the story.
The Rest of the Story
The rest of the story is that not only did the FDA act like an advocacy group, but they and the anti-smoking groups actually acted like pro-smoking advocacy groups. They did the work of Big Tobacco on Thursday, and the beauty of it all is that the tobacco companies didn't have to say a word.
There is no bigger favor that anti-smoking groups or the FDA could do for Big Tobacco than to urge consumers not to use electronic cigarettes. These products represent perhaps the greatest threat to domestic cigarette profits. There are well over 100,000 users of e-cigarettes and most of these users represent former cigarette smokers. Most of the rest are individuals who have greatly cut down on the amount that they smoke. So dollars spent on e-cigarettes are essentially dollars not spent on cigarettes. The higher electronic cigarette consumption is, the lower analog cigarette consumption is.
What the FDA and the anti-smoking groups seemingly fail to realize is that by urging e-cigarette users to stop vaping, they are essentially instructing these individuals to return to cigarette smoking.
For the FDA officials and anti-smoking groups reading this, let me highlight this point: What the FDA and the anti-smoking groups seemingly fail to realize is that by urging e-cigarette users to stop vaping, they are essentially instructing these individuals to return to cigarette smoking.
Why would the FDA and anti-smoking groups want to create an additional 100,000-plus smokers overnight? How is it possibly beneficial for the public's health to have well over 100,000 people who were managing miraculously to keep off of cigarettes to return to cigarette smoking?
There are thousands of testimonials from vapers who had previously been smoking two, there, four packs of cigarettes a day. Many of these smokers had tried NRT to no avail. Many were smokers who had smoked for 20 to 30 years and been unable to quit. Suddenly, they have found a product that enables them to keep off of cigarettes. Or at least to substantially cut down on the amount that they smoke. Many of these vapers testify that their health has improved considerably. Their doctors have expressed amazement at how clear their lungs sound.
Now they have to go back to their doctors and tell them: "Sorry, doc. I had to return to smoking. The FDA and the anti-smoking groups don't want me to be using a relatively clean nicotine-delivery product that has successfully removed most, if not all, of the toxic chemicals and carcinogens that are present in conventional cigarettes. On the FDA's advice, I'm back to my Marlboros."
That's the absurdity of this entire situation: The FDA and the anti-smoking groups would rather that these 100,000 plus individuals smoke Marlboro than use the demonstrably much safer electronic cigarette.
And what is the supposed rationale for harming the health of so many thousands of people by forcing them to go back to the most toxic cigarettes?
Merely that we don't know for sure the definitive safety profile of e-cigarettes.
To which I say: So what? Anyone with a basic familiarity with even high school science realizes that electronic cigarettes are much, much safer than analog ones. A product that delivers nicotine, traces of carcinogens, and even diethylene glycol is obviously much safer than a product which delivers nicotine, huge levels of carcinogens, diethylene glycol, forty other carcinogens, and 10,000 other chemicals and toxins.
Any prudent vaper would draw the logical conclusion that despite a lack of long-term studies on e-cigarettes, it is wiser - from a health perspective - to vape than it is to smoke.
Let's look at it this way: if it was my own family member who we were talking about, I would much rather that the person use electronic cigarettes than return to conventional smoking. For me to instruct the person to go back to regular smoking would be - in my mind - medical malpractice.
Essentially, then, what the FDA and anti-smoking groups are doing is committing medical malpractice on a massive scale: on a population basis.
They are essentially condemning 100,000-plus consumers to a return to the most deadly known consumer product. So many of these individuals have reported a tremendous improvement in their health since switching to electronic cigarettes.
If you are going to undermine this substantial type of health improvement, you had better have a darn good reason. The FDA's carefully staged theatrical production about how e-cigarette cartridges contain traces of carcinogens doesn't cut it. Neither does the hysteria about how kids are going to start vaping left and right, how kids are going to be poisoned by drinking the nicotine cartridges, and how everyone is going to start smoking analog cigarettes because they see the electronic ones.
You see, the FDA and the anti-smoking groups have fallen into a huge analytical trap: they have failed to ask the appropriate question. The question they are asking is: "Are electronic cigarettes safe?" That is not the right question. The right question is: "Are electronic cigarettes much safer than analog ones?"
The FDA and anti-smoking groups are comparing electronic cigarettes to a solution of spring-fresh Maine mountain stream water. What they need to compare electronic cigarettes to is something known as a Marlboro cigarette.
You see, the real threat to our children's health is not electronic cigarettes. It's the damn real ones.
What kids are smoking are not NJoys, InLifes, and Blu's. Kids are smoking Marlboros, Newports, and Camels.
The FDA and the anti-smoking groups damn well better start looking at the actual world around them rather than the ideological fantasy world in which they are living. People are dying and this is no joke. They can joke all they want about the traces of carcinogens in e-cigarettes. But those aren't what are killling 400,000 people a year. I'll say it again: it's the damn real ones.
Thursday, July 23, 2009
FDA Lunacy: Product We Know Will Kill 400,000 People This Year - APPROVED; Product that May Well Help Prevent Many of Those People from Dying: BANNED
Yesterday, the FDA held a major press conference to announce that there are traces of tobacco-specific nitrosamines in electronic cigarette cartridges and that diethylene glycol was detected in one cartridge. Based on those findings, the FDA expressed grave concern over the safety of the product - which is being used by thousands of smokers, literally hundreds of whom have testified that it is more effective than NRT in helping them to stay off cigarettes - and essentially banned the marketing of the product, even threatening criminal action against those who market or sell e-cigarettes.
At the same time that the FDA made a big hullabaloo over the finding of traces of carcinogens in electronic cigarette cartridges, the FDA hid from the public the fact that it would be nearly impossible not to have detected these carcinogens in the cartridges because the nicotine is derived from tobacco and there are residual traces of carcinogens even in nicotine replacement products.
Moreover, the FDA also hid from the public the fact that conventional cigarettes contain and result in human exposure to diethylene glycol, not to mention the fact that they also deliver extremely high exposure to more than 40 different carcinogens, just a few of which are tobacco-specific nitrosamines.
While there is a theoretical risk posed by the diethylene glycol (DEG), it is not clear how high the level of DEG is in the vapor produced by the electronic cigarette and thus the dose delivered to the user is unclear. It is also not clear whether the DEG is present in just this one cartridge or whether the problem is more widespread. Thus, there is no clear evidence that e-cigarettes pose any harm.
What is clear, however, from the FDA testing, is that electronic cigarettes are essentially confirmed as being far, far safer than conventional cigarettes.
Thus, the FDA's decision to ban the much safer electronic cigarettes while approving the deadly conventional ones, is nonsensical.
I prepared the following table to illustrate the FDA's inconsistent treatment of various types of nicotine-delivering products:
At the same time that the FDA made a big hullabaloo over the finding of traces of carcinogens in electronic cigarette cartridges, the FDA hid from the public the fact that it would be nearly impossible not to have detected these carcinogens in the cartridges because the nicotine is derived from tobacco and there are residual traces of carcinogens even in nicotine replacement products.
Moreover, the FDA also hid from the public the fact that conventional cigarettes contain and result in human exposure to diethylene glycol, not to mention the fact that they also deliver extremely high exposure to more than 40 different carcinogens, just a few of which are tobacco-specific nitrosamines.
While there is a theoretical risk posed by the diethylene glycol (DEG), it is not clear how high the level of DEG is in the vapor produced by the electronic cigarette and thus the dose delivered to the user is unclear. It is also not clear whether the DEG is present in just this one cartridge or whether the problem is more widespread. Thus, there is no clear evidence that e-cigarettes pose any harm.
What is clear, however, from the FDA testing, is that electronic cigarettes are essentially confirmed as being far, far safer than conventional cigarettes.
Thus, the FDA's decision to ban the much safer electronic cigarettes while approving the deadly conventional ones, is nonsensical.
I prepared the following table to illustrate the FDA's inconsistent treatment of various types of nicotine-delivering products:
| Nicotine-Delivering Product | Known Serious Health Risks | Known Serious Adverse Effects | Effectiveness for smoking cessation | FDA Position |
| Electronic cigarettes | None | None | No proof, but anecdotal evidence suggests they are more effective than NRT | BANNED |
| NRT | None | None | No evidence they are more effective than cold turkey quitting | APPROVED |
| Chantix | None | Suicide | No evidence they are more effective than cold turkey quitting | APPROVED |
| Cigarettes | Will kill more than 400,000 people this year | Will kill more than 400,000 people this year | None | APPROVED |
You can easily see the insanity here. The product that we know will kill more than 400,000 people this year is APPROVED. The product which has no known serious health risks (although there remains some concern about DEG in some varieties) is BANNED.
The product which delivers nicotine, DEG, and 10,000 other chemicals (including toxins and carcinogens) is APPROVED. But the product which delivers nicotine, DEG, and none (or only traces) of the other 10,000 chemicals, toxins, and carcinogens is BANNED.
Even the FDA's position on Chantix is inconsistent with its position on electronic cigarettes. E-cigarettes are not known to be killing anyone, but they are BANNED. Chantix has been documented to have death as a serious side effect, and it is APPROVED.
Once again, I'm not calling for the removal of Chantix from the market or for the stricter regulation of NRT products (despite what I see as a lack of evidence of their effectiveness). However, I am calling for a more sensical treatment of electronic cigarettes.
While the FDA framed its findings yesterday as demonstrating that electronic cigarettes are dangerous products and that smokers should not use them, I see the results differently. I see the results as confirming the earlier testing of Ruyan e-cigarettes, and as demonstrating that these products almost certainly (beyond any reasonable doubt) present far fewer risks than conventional cigarettes.
Thus, I think that smokers should be encouraged to consider using electronic cigarettes in an effort to quit if they are unable to quit on their own and without nicotine replacement. Smokers who have failed to quit using NRT should also be encouraged to try these products, since there are hundreds of testimonials from smokers who assert that while NRT was inefffective for them, electronic cigarettes have been very effective.
It's clear that the FDA and anti-smoking groups don't realize it, but electronic cigarettes are exactly the kind of safer nicotine-delivery product that we desperately need. The problem with NRT products is that while they effectively deliver nicotine, they do not simulate all the other aspects of smoking, and thus they are ineffective in keeping smokers off of cigarettes.
The beauty of e-cigarettes is that they not only deliver the nicotine, but they almost completely simulate the act of smoking. This is what vapers (e-cigarette users) consistently cite as being the reason why they are far more effective than NRT products.
You see, addiction to smoking is about far more than just addiction to nicotine. The entire act of smoking - all aspects of the behavior - are part of the addiction and enticement of the act. You can replace the nicotine, but you are still not replacing all the various aspects of the behavior. Electronic cigarettes come as close as is yet possible to doing this, and for that reason, they appear to be more effective than any other smoking cessation medicine/device.
In fact, the factor that makes the electronic cigarette so apparently effective is the precise factor which makes it so distasteful to anti-smoking groups. These groups just cannot tolerate the idea that a smoker would continue to go through the act of smoking. The issue of whether or not the behavior is orders of magnitude safer is not relevant in the anti-smoking mindset (or in the FDA's mindset, apparently). All that matters is that the smoker achieve abstinence. And it is not abstinence from nicotine they are talking about. It is abstinence from the act of smoking.
The CDC argued during yesterday's press conference that electronic cigarettes are going to encourage youths to smoke because it looks like someone is smoking. In other words, the CDC readily admitted that what is troublesome is the fact that these products simulate smoking, not that they are actually going to be more harmful to smokers. Other anti-smoking advocates predicted that these devices or going to attract youths, largely because the nicotine comes in flavored varieties.
But how genuine are these concerns? The FDA just approved cinnamon and cherry-flavored nicotine lozenges, and the anti-smoking groups expressed no concern over those products.
I don't think there's any question that the lozenges pose a far greater danger of youth abuse than e-cigarettes. Why? Because they are readily available and relatively inexpensive, while the electronic cigarettes require a youth to shell out 100 bucks, and that doesn't even get them the cartridges.
This doesn't mean that there aren't problems with e-cigarettes that need to be addressed. This doesn't mean that e-cigarette manufacturers shouldn't be asked to make certain changes, such as instituting tighter quality control procedures and making sure that the propylene glycol is devoid of diethylene glycol. This doesn't mean that there shouldn't be restrictions on the sale of these devices to minors. But it does mean that it is lunacy to ban the product, especially in light of how the very same FDA is now approving the well-known to be deadly Marlboros, Winstons, Kools, Newports, Camels, and others.
The rest of the story is that the FDA and anti-smoking groups have apparently lost sight of the actual objective of public health regulation: to improve the overall population's health. The combination of FDA approval of conventional cigarettes and FDA banning of the much safer electronic ones is ludicrous, will have detrimental population health effects, and sends exactly the wrong message to the public.
Wednesday, July 22, 2009
Tobacco-Specific Carcinogens Found in Nicotine Replacement Products; Will Anti-Smoking Groups Call for Removal of these Products from the Market?
Despite Laboratory Finding of Carcinogens in Nicotine Replacement Medications, FDA Fails to Hold Press Conference to Express Concern About Potential Dangers of Nicotine Replacement Products
The FDA today expressed concern about the safety of electronic cigarettes, due mainly to the detection of tobacco-specific nitrosamines (a carcinogen) in these products.
The FDA wrote: "The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed."
Based on the laboratory finding reported today by the FDA that electronic cigarette cartridges have detectable levels of tobacco-specific nitrosamines, the American Lung Association (ALA) has called for the removal of electronic cigarettes from the market.
In a press release entitled "American Lung Association Supports Food and Drug Administration Finding that E-Cigarettes are Harmful and Contain Carcinogens; Lung Association Urges FDA to Immediately Halt the Sale of Unapproved Products," the ALA wrote that: "FDA’s preliminary findings show e-cigarettes contain carcinogens and toxic chemicals, including ingredients found in antifreeze. ... For too long, e-cigarette manufacturers have sold these nicotine delivery devices – absent FDA review and approval. ... In light of these initial findings, the American Lung Association urges the FDA to act immediately to halt the sale and distribution of all e-cigarettes unless the products have been reviewed and approved for sale by the FDA."
At a press conference earlier today, the FDA released the results of laboratory testing of 18 types of electronic cigarette cartridges and reported that tobacco-specific nitrosamines (a carcinogen) were detected in five of the cartridges. Diethylene glycol was detected in one of 18 cartridges tested.
The FDA expressed concern over the safety of electronic cigarettes and announced that it may take enforcement action against the product. However, the FDA stopped short of declaring that it will pull electronic cigarettes off the market.
The Rest of the Story
What the FDA did not tell the media or the public, and what the American Lung Association failed to express alarm over, is the fact that nicotine replacement products themselves have been found to have detectable levels of tobacco-specific nitrosamines, including 4-(methylnirosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN). Both of these chemicals are consistently carcinogenic in laboratory animals and are widely recognized as carcinogens present in tobacco products.
The carcinogen NNK [4-(methylnirosamino)-1-(3-pyridyl)-1-butanone] was found to be present at a concentration of 0.008 micrograms per patch in NicoDerm CQ and NNN [N'-nitrosonornicotine] was found to be present at a concentration of 0.002 micrograms per piece in Nicorette.
Given the finding that nicotine replacement products and electronic cigarettes both contain carcinogens, why is it that the American Lung Association is only calling for the recall of electronic cigarettes, not other nicotine replacement products? Shouldn't the ALA also express concern about nicotine replacement medications due to the fact that they create documented exposure to carcinogens and that there is therefore no safe level of exposure to nicotine replacement products?
Also, shouldn't the FDA hold a similar press conference tomorrow to express concern over the safety of nicotine replacement medications, since these products expose consumers to known tobacco-specific carcinogens?
The FDA and several anti-smoking speakers also expressed concern over the potential use of electronic cigarettes by youths, due to the marketing of flavored versions of these products.
But the same FDA just gave approval to a pharmaceutical company to market cinnamon and cherry flavored nicotine lozenges. Don't these products also present a concern about the potential for youths to try them and be poisoned by the nicotine? Why are the anti-smoking groups silent about the marketing of cinnamon and cherry-flavored lozenges? Can you get any closer than that to a candy product?
Another concern of the FDA and the anti-smoking groups was that we don't have evidence that electronic cigarettes are effective for smoking cessation. Well, one can make the same argument about nicotine replacement products. And one can also argue that we know that Chantix is not safe. It has purportedly resulted in hundreds if not thousands of severe adverse effects including suicides.
My point is that the actions of the anti-smoking groups are hypocritical. How can they argue that electronic cigarettes - which have been found to have detectable level of carcinogens - should be removed from the market, while nicotine replacement products - which also have detectable levels of carcinogens - should be allowed to remain? Furthermore, why should Chantix, which is thought to have resulted in a number of actual deaths, be allowed to remain on the market? And, most important of all, why would the same anti-smoking groups that want e-cigs pulled off the market because we are not absolutely sure if they are safe support the FDA approval of all conventional cigarettes, despite their documented high levels of carcinogens?
I find it to be a joke that the FDA is making a huge deal out of the finding that there may be some small risk associated with electronic cigarettes at the same time it is poised to start approving a product that we know is going to kill more than 400,000 people over the next year. There wasn't any FDA press conference today about the health risks of cigarettes, smokeless tobacco products, or any of the tobacco products over which the FDA now has jurisdiction. How does that make any sense? And why is the FDA allowing Chantix to remain on the market when we know that it has already killed perhaps hundreds of people?
Remember, the valid question is not whether or not electronic cigarettes are safe. The question is whether or not electronic cigarettes are much safer than conventional ones. If they are, and if they help keep people off of the known highly toxic cigarette variety, then they could be a huge benefit to the public's health. We surely wouldn't want to pull them from the market, forcing vapers to return to the highly toxic conventional cigarettes, when these products may actually be saving their lives.
If you look at the laboratory data provided by the FDA, you'll see that what is conspicuously missing is the results of the same exact testing of nicotine replacement products. While a nicotine inhaler was used as a control specimen for the nicotine testing, it was not subjected to testing for carcinogens?
Why not? Why would the FDA lab use the nicotine inhaler as a control specimen, but refuse to test it for carcinogens, just as electronic cigarettes were tested for carcinogens?
That, my friends, is inexcusable. It is deliberately trying to hide something from the public.
The report states that: "Nicotrol inhaler was used as a control for some test methods." Why only some test methods? If we are about to ban electronic cigarettes but keep NRT products, based on the finding that e-cigs have detectable levels of carcinogens, wouldn't we first want to demonstrate that e-cigs, unlike NRT products, have detectable levels of carcinogens?
For everyone's information, the finding that electronic cigarettes contain detectable levels of carcinogens is not new. We've known that for a long time. It's absolutely expected. Because the nicotine is derived from tobacco, it's close to impossible to isolate nicotine without retaining at least traces of the other tobacco constituents. That's the reason why pharmaceutical nicotine products also contain detectable levels of carcinogens.
The other thing that the FDA lab did not report is the level of the carcinogens in the electronic cigarette cartridges. One reason why the carcinogen levels in NRT products is not of tremendous concern is that the levels are orders of magnitude lower than in cigarettes (about two orders of magnitude at minimum, as I showed above). Before drawing any conclusions from the FDA lab results, we need to know the absolute level of the carcinogens, not just whether they were detectable. If the FDA has reviewed the literature (which it obviously has), it would know that nicotine replacement products themselves contain detectable levels of carcinogens. So the finding of detectable levels of carcinogens in e-cigs is not significant. What matters is the level of those carcinogens, and that is not something that the FDA has (yet) reported.
The detection of diethylene glycol (DEG) in one of the 18 cartridges is concerning and it may be that better techniques are necessary for preparing the propylene glycol solution. The level of DEG in that sample was significant. What is not clear is the dose of DEG that would be delivered through inhalation of the vaporized mixture. Most cases of antifreeze poisoning I am aware of have occured through ingestion, not inhalation of vapors. This is clearly an area of legitimate concern, but in and of itself, it doesn't mean that it would be prudent to recall the product from the market.
The decision about how to handle electronic cigarettes requires a careful consideration of the overall public health implications of the use of the product. One needs to weigh the clear benefits that this product appears to be having - the potential for a massive saving of lives from what could possibly be a breakthrough in smoking cessation technology - with the possible risks as well as the costs of forcing vapers to go back to conventional cigarette smoking (something which may have substantial public health costs).
The American Lung Association's simplistic view of this issue - there are carcinogens detected in e-cigs so they must be pulled from the market - is inappropriate, and could do far more harm than good.
To be sure, this is a challenging and complicated public health issue. But what it requires is not simplistic, ideological-based thinking. It requires taking a broad view and making a broad assessment of overall public health implications. It also requires objective and meaningful science, not just whether or not carcinogens are detectable in the product (something which we knew long before the FDA studied the product and something which is hardly relevant, since NRT products themselves contain detectable levels of carcinogens). It also requires consistency and rationality, and not blind adherence to any particular legal or policy ideology.
Most imporantly, it requires balanced, meaningful, and honest communication with the media and with the public. How meaningful is it to tell the media that e-cigarettes contain carcinogens and not to tell those same reporters that nicotine replacement products also contain carcinogens. A reporter walking away from that press conference is going to get the wrong impression. Perhaps that's by design, but I think it's unfortunate.
Just to make it clear, if one wanted to present a scare about NRT, one could easily do it by performing a lab analysis and holding a press conference to announce that there are detectable levels of several known human carcinogens in these products. This is the type of presentation that could easily be used to advocate for the removal of NRT from the market.
To be sure, there's plenty of reason for concern about electronic cigarettes. There's plenty of reason to take actions to ensure the product remains out of the hands of kids, to be sure that the labeling and advertising claims are accurate and supported, and to study the product for both safety and efficacy in smoking cessation. But the knee-jerk response of banning the product is not necessarily in the best interests of protecting the public's health. Most importantly, the evidence used to take such an action must be solid - the simple finding of detectable levels of carcinogens in the product or potential risk of harm from the product is not sufficient. By those grounds, the FDA should also be pulling nicotine replacement products from the market, and it should have pulled Chantix from the market months ago.I think this is a perfect demonstration of why there's a need for the "rest of the story."
REFERENCES
1. For the study which documents detectable levels of carcinogens in pharmaceutical nicotine replacement products, see: Stepanov I, Jensen J, Hatsukami D, Hecht SS. Tobacco-specific nitrosamines in new tobacco products. Nicotine and Tobacco Research 2006; 8:309-313.
2. For the previous laboratory report which had already documented trace levels of carcinogens in electronic cigarettes, see: Laugesen M. Safety report on the Ruyan e-cigarette cartridge and inhaled aerosol. Christchurch, New Zealand: Health New Zealand Ltd, 2008.