Here is a reprint, with her permission, of a piece based on a comment by Kristin posted to an article by an online 'journalist' that was obviously unresearched and repeated much of the FDA spin. It is a model of factual presentation of the situation together with a reasoned explanation of the opposition to e-cigarettes by government agencies. It clearly presents:
- What the FDA actually found in an e-cigarette analysis
- How and why they distorted and misrepresented the facts
- Why a government agency would lie and distort
- Why a government agency will act directly against the interests of public health if there is a financial incentive to do so
- It counters the public perception that the FDA is a respectable agency defending the public
- It delicately introduces the concept that corruption is possible in government, without direct accusation
You may use this material as the basis for your own replies to the more and more common 'junk filler' articles seen online or elsewhere. There are far fewer properly-researched articles such as David Kesmodel's piece for the Wall Street Journal that was written after consultation with us - it's much easier to recycle the FDA's junk.
_________________________________________________________
If a journalist is going to write about a topic, wouldn't it be that professional's due diligence to know all of the facts?
A common question about e-cigarettes is, "If they are safe, why would the US Food and Drug Administration oppose it?".
When confronted with counter-intuitive behavior by the government or an industry, the first step is to follow the money. As an example, the media recently reported the story behind a promising cancer drug, dichloroacetate (DCA). While studies show that it has had great success in treating some cancers in lab rats, no pharmaceutical company is interested in financing human trials. It seems this drug is unpatentable, so drug companies cannot profit from it as a cancer treatment.
Follow the money - there is no profit in it as a patent-free drug, so monetary gain (or lack of it) trumps public health.
E-cigarettes are a threat to two major revenue streams - pharmaceutical company nicotine cessation product profits and government tobacco taxes. Consider that in the 3 years they have been available in the US (7 years on the world market), the FDA has reported no serious illness or injury linked to e-cigarette use. The FDA report announced in July 2009 didn't find toxic levels of any chemical or dangerous levels of possible carcinogens, yet they are making every effort to discourage the public from using the devices by misleading them to believe that they contain dangerous "anti-freeze" chemicals (diethylene glycol) and dangerous levels of carcinogens.
If they were being honest with the public, they would have told them that the levels of carcinogens they found are the same as those found in the FDA-approved nicotine patch. The FDA has issued no warnings that the levels of carcinogens in the patch are dangerous, so why the warning for those same levels in e-cigarettes? It's obvious that they don't contain anti-freeze or we'd have reports of DEG poisoning from the millions of e-cigarette users around the world. Levels of DEG found in one e-cigarette were way too low to be dangerous, and propylene glycol, a common ingredient - used to make anti-freeze less toxic - is FDA-approved for human consumption and is GRAS, Generally Regarded As Safe. It is of course the base for injectable and inhalable medicines fully approved by the FDA (and the 'fog' in disco fog machines, which is also fully approved as safe).
So, the evidence to date shows e-cigarettes to be non-toxic, to have extremely low levels of carcinogens, especially compared to cigarettes, and there have been no reports of serious illness or injury - despite what amounts to the largest-scale new product trial in history, with millions of users over many years, and which has shown precisely zero issues (which in itself is probably unheard of in any kind of medical trial) - yet the FDA calls them potentially dangerous and wants them off the market. Where is the logic? Where is the supporting evidence? Follow the money...
The only evidence of danger from e-cigarettes to date is the threat to pharmaceutical industry profits and government tax revenues.
Another common misconception is that e-cigarettes are to be used in the same manner as pharmaceutical treatments for nicotine addiction and that users are expected to eventually wean themselves off nicotine altogether. While this may be true for pharmaceutical nicotine reduction therapies (NRTs), this is not the case for e-cigarettes. For the majority of e-cigarettes users surveyed, the devices are used as intended - to continue to use nicotine - not to gradually reduce, then cease use.
E-cigarettes are an alternative form of smoking, and not a treatment, since nicotine use, absent the smoke, is no more dangerous than caffeine use. That is why even smokeless tobacco has been scientifically shown to have 98-99% less risk than smoking cigarettes. That is why pharmaceutical companies are petitioning the FDA to allow them to increase the nicotine dosage and allow for long-term use of their gums and lozenges - products which receive direct competition from the lozenges and strips made by tobacco companies. That is why GlaxoSmithKline petitioned the FDA to have those smokeless tobacco products banned, while simultaneously asking to expand their own smokeless nicotine market.
Consider the recent CDC report that smoking quit rates have stagnated. Even with all of the efforts of anti-tobacco groups, people still smoke. Rather than expecting people to quit using nicotine, the smarter route is to use a harm reduction approach. Encouraging nicotine users to greatly reduce their exposure to toxins, rather than quit nicotine altogether, would have a significant impact on public health by reducing risks up to 99%.
Reduced harm is now firmly accepted both in consumer health decisions and in medical treatment - consider that low-fat products are encouraged, rather than expecting people to quit eating fat altogether. Consider that using seat belts is encouraged, rather than quitting driving altogether. Consider that condoms are encouraged, rather than quitting sex altogether. Consider that taking a cab or having a designated driver is encouraged, rather than quitting drinking altogether. This is not a new or complicated concept, and applies to both personal decisions and medical care.
A personal decision by a consumer to reduce risk is known as Harm Reduction, and medical management of treatment of this nature is known as Harm Management. These concepts are believed to be among the most important health advances of recent years by public health medical experts.
When you hear e-cigarette users talk of "quitting smoking" they are being quite literal - they quit smoking, but they did not quit nicotine use. According to surveys, most e-cigarette users have no intention of quitting nicotine and they shouldn't have to - anymore than people are expected to quit other low risk behaviors such as social drinking, sex, coffee, driving their cars or eating ice cream. E-cigarettes are overwhelmingly advertised as smoking alternatives - they are a reduced-risk form of smoking and do not treat a disease.
Consider drunk driving. Science has given us the IIS (Ignition Interlock System). This device stops alcoholics from one of the most dangerous behaviors associated with alcohol addiction - drunk driving - yet it does not treat alcoholism itself. E-cigarettes stop one of the most dangerous aspects of nicotine use - inhaling toxic smoke - but they are not intended to treat nicotine addiction. Just because some people use it that way - just as they could chew on toothpicks or suck on a straw to quit their nicotine use - that does not make it the product's primary, intended use.
Some opponents to e-cigarettes point to companies which add ingredients for weight loss or erectile dysfunction and claim this as a reason to close down e-cigarette companies. This amounts to tossing the baby out with the bathwater. Yes, there are some unethical e-cigarette companies out there and some of them make outrageous claims. These companies are why the FDA was created and there are many laws already in place to address them. However, the FDA is attempting to lump the small number bad apples in with all the ethical companies - probably less than 1% of the industry is associated with this unethical marketing, and the FDA has all the tools it needs to close them down.
If a company that sells bottled water started adding additional ingredients to the water and claimed that it cures cancer, would it be logical for the FDA to ban all bottled water, even from those companies which make no claims or additions? Yet, that is what they are doing to the e-cigarette industry.
Finally, some pharma-backed pressure groups claim that FDA-approved nicotine cessation products are a better choice and e-cigarette companies only care about profits. This is implying that the FDA and the pharmaceutical companies actually have our best interests as a priority. These groups (such as the ALA, ACS and AHA), which heavily promote pharmaceutical products, receive huge amounts of funding from pharmaceutical companies. They have become massive organizations themselves, with highly-paid executives. Are you sure they are still looking out for us? While the typical, low-level volunteer may be concerned about public health, they take their orders from executives whose income is directly linked to pharmaceutical companies. These groups have also actively opposed proposed legislation to ban e-cigarette sales to minors, in order to further their agenda to remove e-cigarettes from the market completely. If they are so concerned about these getting into the hands of minors, why would they turn down legislation addressing this concern?
You might also consider the logic of that argument: are youngsters going to pay $40 to $150 for a smoking product when the alternative is $7 or $8 - or free from a friend?
Pharmaceutical companies certainly aren't charities and logic dictates they must prioritize for profit; the example of the potentially life-saving cancer drug ignored as it has little potential profit shows that their motives are not altruistic, just in case there is any doubt. You could say that the FDA is there to keep them honest, but considering all of the news these days of FDA-approved drugs that are killing and severely injuring people and that the FDA only requires a little black box of warnings that no one ever reads, their competence in their given duties seems suspect. It should also be noted that the FDA have lost several court cases brought against them by doctors who believed that their actions were against the best interests of public health, and where judges clearly agreed.
People are starting to ask if perhaps the FDA is a little too closely aligned with the pharmaceutical industry. Since the interests of pharma and the public are directly opposed in many if not all cases, perhaps that would not be such a good idea. A pharmaceutical regulatory agency should be totally independent, and above all, always act in the public interest even when that is against the interest of the pharmaceutical industry. This is demonstrably not happening right now.
If the FDA is concerned about minors and regulation, all they would have to do is classify e-cigarettes as tobacco products, rather than continuing this fight to classify them as the drug treatments they aren't. E-cigarettes would immediately be subject to the same restrictions and regulation as other tobacco products - no sales to minors, limited advertising, etc. Yet the FDA continues toward its irrational goal of categorizing a product intended to safely sustain nicotine use, as a nicotine addiction treatment - which is as logical as regulating caffeine as a drug treatment for fatigue and requiring coffee distributors to meet the same production standards as pharmaceutical drugs.
There is no reason to mistrust the majority of e-cigarette companies. In fact, most are small business owners who discovered e-cigarettes as smokers, sincerely believe in them, and saw their potential. While they should be regulated - as far as reasonable production standards, product consistency and accurate labeling - they don't warrant any more distrust than any other company.
If you would like to know more of the facts, so you may make an informed opinion, please don't hesitate to contact CASAA or check out the informational website at:
www.casaa.org
It is our (unpaid) mission to inform the public of the truth about smokeless, reduced-harm alternatives.
________________________________________________________
- What the FDA actually found in an e-cigarette analysis
- How and why they distorted and misrepresented the facts
- Why a government agency would lie and distort
- Why a government agency will act directly against the interests of public health if there is a financial incentive to do so
- It counters the public perception that the FDA is a respectable agency defending the public
- It delicately introduces the concept that corruption is possible in government, without direct accusation
You may use this material as the basis for your own replies to the more and more common 'junk filler' articles seen online or elsewhere. There are far fewer properly-researched articles such as David Kesmodel's piece for the Wall Street Journal that was written after consultation with us - it's much easier to recycle the FDA's junk.
_________________________________________________________
If a journalist is going to write about a topic, wouldn't it be that professional's due diligence to know all of the facts?
A common question about e-cigarettes is, "If they are safe, why would the US Food and Drug Administration oppose it?".
When confronted with counter-intuitive behavior by the government or an industry, the first step is to follow the money. As an example, the media recently reported the story behind a promising cancer drug, dichloroacetate (DCA). While studies show that it has had great success in treating some cancers in lab rats, no pharmaceutical company is interested in financing human trials. It seems this drug is unpatentable, so drug companies cannot profit from it as a cancer treatment.
Follow the money - there is no profit in it as a patent-free drug, so monetary gain (or lack of it) trumps public health.
E-cigarettes are a threat to two major revenue streams - pharmaceutical company nicotine cessation product profits and government tobacco taxes. Consider that in the 3 years they have been available in the US (7 years on the world market), the FDA has reported no serious illness or injury linked to e-cigarette use. The FDA report announced in July 2009 didn't find toxic levels of any chemical or dangerous levels of possible carcinogens, yet they are making every effort to discourage the public from using the devices by misleading them to believe that they contain dangerous "anti-freeze" chemicals (diethylene glycol) and dangerous levels of carcinogens.
If they were being honest with the public, they would have told them that the levels of carcinogens they found are the same as those found in the FDA-approved nicotine patch. The FDA has issued no warnings that the levels of carcinogens in the patch are dangerous, so why the warning for those same levels in e-cigarettes? It's obvious that they don't contain anti-freeze or we'd have reports of DEG poisoning from the millions of e-cigarette users around the world. Levels of DEG found in one e-cigarette were way too low to be dangerous, and propylene glycol, a common ingredient - used to make anti-freeze less toxic - is FDA-approved for human consumption and is GRAS, Generally Regarded As Safe. It is of course the base for injectable and inhalable medicines fully approved by the FDA (and the 'fog' in disco fog machines, which is also fully approved as safe).
So, the evidence to date shows e-cigarettes to be non-toxic, to have extremely low levels of carcinogens, especially compared to cigarettes, and there have been no reports of serious illness or injury - despite what amounts to the largest-scale new product trial in history, with millions of users over many years, and which has shown precisely zero issues (which in itself is probably unheard of in any kind of medical trial) - yet the FDA calls them potentially dangerous and wants them off the market. Where is the logic? Where is the supporting evidence? Follow the money...
The only evidence of danger from e-cigarettes to date is the threat to pharmaceutical industry profits and government tax revenues.
Another common misconception is that e-cigarettes are to be used in the same manner as pharmaceutical treatments for nicotine addiction and that users are expected to eventually wean themselves off nicotine altogether. While this may be true for pharmaceutical nicotine reduction therapies (NRTs), this is not the case for e-cigarettes. For the majority of e-cigarettes users surveyed, the devices are used as intended - to continue to use nicotine - not to gradually reduce, then cease use.
E-cigarettes are an alternative form of smoking, and not a treatment, since nicotine use, absent the smoke, is no more dangerous than caffeine use. That is why even smokeless tobacco has been scientifically shown to have 98-99% less risk than smoking cigarettes. That is why pharmaceutical companies are petitioning the FDA to allow them to increase the nicotine dosage and allow for long-term use of their gums and lozenges - products which receive direct competition from the lozenges and strips made by tobacco companies. That is why GlaxoSmithKline petitioned the FDA to have those smokeless tobacco products banned, while simultaneously asking to expand their own smokeless nicotine market.
Consider the recent CDC report that smoking quit rates have stagnated. Even with all of the efforts of anti-tobacco groups, people still smoke. Rather than expecting people to quit using nicotine, the smarter route is to use a harm reduction approach. Encouraging nicotine users to greatly reduce their exposure to toxins, rather than quit nicotine altogether, would have a significant impact on public health by reducing risks up to 99%.
Reduced harm is now firmly accepted both in consumer health decisions and in medical treatment - consider that low-fat products are encouraged, rather than expecting people to quit eating fat altogether. Consider that using seat belts is encouraged, rather than quitting driving altogether. Consider that condoms are encouraged, rather than quitting sex altogether. Consider that taking a cab or having a designated driver is encouraged, rather than quitting drinking altogether. This is not a new or complicated concept, and applies to both personal decisions and medical care.
A personal decision by a consumer to reduce risk is known as Harm Reduction, and medical management of treatment of this nature is known as Harm Management. These concepts are believed to be among the most important health advances of recent years by public health medical experts.
When you hear e-cigarette users talk of "quitting smoking" they are being quite literal - they quit smoking, but they did not quit nicotine use. According to surveys, most e-cigarette users have no intention of quitting nicotine and they shouldn't have to - anymore than people are expected to quit other low risk behaviors such as social drinking, sex, coffee, driving their cars or eating ice cream. E-cigarettes are overwhelmingly advertised as smoking alternatives - they are a reduced-risk form of smoking and do not treat a disease.
Consider drunk driving. Science has given us the IIS (Ignition Interlock System). This device stops alcoholics from one of the most dangerous behaviors associated with alcohol addiction - drunk driving - yet it does not treat alcoholism itself. E-cigarettes stop one of the most dangerous aspects of nicotine use - inhaling toxic smoke - but they are not intended to treat nicotine addiction. Just because some people use it that way - just as they could chew on toothpicks or suck on a straw to quit their nicotine use - that does not make it the product's primary, intended use.
Some opponents to e-cigarettes point to companies which add ingredients for weight loss or erectile dysfunction and claim this as a reason to close down e-cigarette companies. This amounts to tossing the baby out with the bathwater. Yes, there are some unethical e-cigarette companies out there and some of them make outrageous claims. These companies are why the FDA was created and there are many laws already in place to address them. However, the FDA is attempting to lump the small number bad apples in with all the ethical companies - probably less than 1% of the industry is associated with this unethical marketing, and the FDA has all the tools it needs to close them down.
If a company that sells bottled water started adding additional ingredients to the water and claimed that it cures cancer, would it be logical for the FDA to ban all bottled water, even from those companies which make no claims or additions? Yet, that is what they are doing to the e-cigarette industry.
Finally, some pharma-backed pressure groups claim that FDA-approved nicotine cessation products are a better choice and e-cigarette companies only care about profits. This is implying that the FDA and the pharmaceutical companies actually have our best interests as a priority. These groups (such as the ALA, ACS and AHA), which heavily promote pharmaceutical products, receive huge amounts of funding from pharmaceutical companies. They have become massive organizations themselves, with highly-paid executives. Are you sure they are still looking out for us? While the typical, low-level volunteer may be concerned about public health, they take their orders from executives whose income is directly linked to pharmaceutical companies. These groups have also actively opposed proposed legislation to ban e-cigarette sales to minors, in order to further their agenda to remove e-cigarettes from the market completely. If they are so concerned about these getting into the hands of minors, why would they turn down legislation addressing this concern?
You might also consider the logic of that argument: are youngsters going to pay $40 to $150 for a smoking product when the alternative is $7 or $8 - or free from a friend?
Pharmaceutical companies certainly aren't charities and logic dictates they must prioritize for profit; the example of the potentially life-saving cancer drug ignored as it has little potential profit shows that their motives are not altruistic, just in case there is any doubt. You could say that the FDA is there to keep them honest, but considering all of the news these days of FDA-approved drugs that are killing and severely injuring people and that the FDA only requires a little black box of warnings that no one ever reads, their competence in their given duties seems suspect. It should also be noted that the FDA have lost several court cases brought against them by doctors who believed that their actions were against the best interests of public health, and where judges clearly agreed.
People are starting to ask if perhaps the FDA is a little too closely aligned with the pharmaceutical industry. Since the interests of pharma and the public are directly opposed in many if not all cases, perhaps that would not be such a good idea. A pharmaceutical regulatory agency should be totally independent, and above all, always act in the public interest even when that is against the interest of the pharmaceutical industry. This is demonstrably not happening right now.
If the FDA is concerned about minors and regulation, all they would have to do is classify e-cigarettes as tobacco products, rather than continuing this fight to classify them as the drug treatments they aren't. E-cigarettes would immediately be subject to the same restrictions and regulation as other tobacco products - no sales to minors, limited advertising, etc. Yet the FDA continues toward its irrational goal of categorizing a product intended to safely sustain nicotine use, as a nicotine addiction treatment - which is as logical as regulating caffeine as a drug treatment for fatigue and requiring coffee distributors to meet the same production standards as pharmaceutical drugs.
There is no reason to mistrust the majority of e-cigarette companies. In fact, most are small business owners who discovered e-cigarettes as smokers, sincerely believe in them, and saw their potential. While they should be regulated - as far as reasonable production standards, product consistency and accurate labeling - they don't warrant any more distrust than any other company.
If you would like to know more of the facts, so you may make an informed opinion, please don't hesitate to contact CASAA or check out the informational website at:
www.casaa.org
It is our (unpaid) mission to inform the public of the truth about smokeless, reduced-harm alternatives.
________________________________________________________
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