FDA Spokesperson Says Tobacco Cigarettes are No More Dangerous than Electronic Cigarettes; The World is Believing It as Irrational Policies Spread

In an interview on NPR's Morning Edition last April, FDA spokeswoman Rita Chappelle stated about electronic cigarettes: "We're concerned about the potential for addiction to and abuse of these products. Some people may mistakenly perceive these products to be safer alternatives to conventional tobacco use."

The FDA more recently followed up its initial assertion that e-cigarettes are no safer than the real ones by holding a press conference at which it tried to scare electronic cigarette users into returning to real cigarettes by alarming them about the carcinogens detected in the product, but without telling them that the levels were no higher than in nicotine replacement products and that they are 1400 times lower than in Marlboros.

At the same time, the Congress, upon the urging of Philip Morris and the major anti-smoking groups, have put the FDA in the position of being forced to approve tobacco cigarettes for marketing and sale in the United States.

Thus, the message being sent to the world is that the anti-smoking groups and the federal government are perfectly comfortable with conventional cigarettes and are approving them, while the electronic ones, with which we are not familiar, represent a huge danger. They are as hazardous as regular cigarettes and smokers should stick with the real ones rather than quit by trying this innovative product.

The Rest of the Story

Several countries, including Saudi Arabia and Israel, have reacted to the FDA's announcements and actions by banning electronic cigarettes at the same time as they allow the real ones. These policies appear to be based, in part, on the misperception not only that electronic cigarettes are no safer than real ones, but that they are actually more hazardous.

For example, according to an article in The Peninsula: "Saudi Arabia is one of the leading countries that have banned the sale of e-cigarettes because of the harm the devices cause. ... Upon testing it was found that the e-cigarette harms human health far more than the normal cigarette...".

It is clear that the combination of the passage of the FDA tobacco legislation and the misleading information about electronic cigarettes have led to a situation in which we are sending the message that cigarette smoking is just not as bad as previously thought. A device which, as far as we know, delivers nicotine without any of the other 10,000 plus chemicals in tobacco smoke is apparently far more worrisome than cigarettes.

In other words, my predictions about the devastating effects of the FDA tobacco legislation on the public's understanding of the hazards of cigarette smoking are coming true, and the legislation has not even been implemented yet.

The anti-smoking groups can talk all they want about the legislation preventing the tobacco companies from telling the public that the FDA now approves cigarettes for sale in the United States, but the truth is that even without tobacco companies saying anything, the public - and literally, the world - is experiencing a complete undermining of years of public education and campaigning about the devastating hazards of cigarette smoking.

I truly believe that the anti-smoking groups have, as I predicted, undermined decades of education about the hazards of cigarette smoking.

Now, the message going out to the public is: the FDA now approves cigarettes, they are not as bad as we thought, they are no worse than electronic ones which don't even contain tobacco nor deliver tobacco smoke, they might even be safer than the electronic ones.

What the anti-smoking groups have done is provide a huge gift to Big Tobacco. They have done more to protect the sale of cigarettes in the U.S. and abroad than anything the tobacco companies have themselves done in response to the FDA legislation or the threat of electronic cigarettes.

The beauty of the FDA legislation, from Big Tobacco's perspective, is that the tobacco companies no longer need to conduct their own public relations to protect the image of their product. The anti-smoking groups are now doing all that work for Big Tobacco.

I need to make it clear that anti-smoking groups - and the FDA - have not just figuratively, but literally informed the public that cigarette smoking is no worse than inhaling relatively pure nicotine.

The FDA spokesperson clearly stated that electronic cigarettes are no safer than real ones. Which, of course, means that the real ones are no more dangerous than these electronic devices. This is not only false, but it is an extremely damaging communication to provide to the public, as it destroys years of education about the hazards of cigarette smoking.

Action on Smoking and Health, as I reported several days ago, told the public that other than the nicotine, there is nothing in cigarettes that causes cardiovascular disease. This, too, is an untruthful and damaging communication that completely undermines what I and many others have been doing for years to try to educate the public about the extreme hazards of cigarette smoking.

Do we really want the public to believe that other than nicotine, there is no risk to cardiovascular health from cigarette smoking? Do we really want the public to believe that in terms of cardiovascular disease, there is no benefit in using a nicotine patch rather than smoking 2 packs of Marlboros a day? Do we really want the public to believe that if they quit smoking and switch over to a nicotine inhaler, they are doing nothing to reduce their risk of cardiovascular disease?

Unfortunately, this is exactly what ASH's communication indicated to the public.

Do we really want the public to believe that the inhalation of nicotine vapor is more dangerous than the inhalation of nicotine combined with more than 10,000 plus chemicals and 57 carcinogens? Do we even want the public to believe that the inhalation of nicotine vapor is equally dangerous to the inhalation of nicotine combined with those 10,000 plus chemicals and 57 carcinogens?

Unfortunately, this is exactly what the FDA's communication indicated to the public.

I feel that the FDA and anti-smoking groups owe it to the public to correct their misleading communications, and to state - unequivocally - to the public and the world that cigarette smoking is much more hazardous than using an electronic smoking device and that there is no existing evidence that the electronic cigarette poses anything close to the same level of risk as conventional cigarette smoking.

Anything less than that is doing a huge disservice to the public.

Unfortunately, the FDA tobacco legislation is already the law, so there is little to nothing that can be done to alter the public's perception that cigarettes are approved by the FDA. However, at very least, the anti-smoking groups and the FDA can get the message out there that despite their approval, they are still extraordinarily dangerous products and that the public should do anything it can to quit - even if that means using a device which is almost certainly much less dangerous, but in the absence of definitive evidence from clinical trials.

Washington Times Op-Ed: Why are Anti-Smoking Groups Promoting Cigarette Smoking over Quitting?

An op-ed by Dr. Elizabeth Whelan - president of the American Council on Science and Health - in today's Washington Times asks why anti-smoking groups are promoting cigarette smoking over quitting by urging electronic cigarette users to return to the real cigarettes. Somehow, Dr. Whelan notes, anti-smoking groups seem to feel more comfortable with the idea of smokers using a product that we are familiar with, even though the product is responsible for what Dr. Whelan states are more than 450,000 deaths per year in the U.S.

Dr. Whelan writes: "At a time when the government is ostensibly trying to cut health costs, why is it trying to ban something that might help people quit smoking tobacco, perhaps the most devastating health problem in the U.S.? The Food and Drug Administration (FDA) held a press conference late last month to scare Americans about the so-called "e-cigarette" -- claiming it was loaded with harmful "toxins" and "carcinogens." The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes -- better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S."

"In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk."

The Rest of the Story

On the heels of last night's NPR story on electronic cigarettes, I think we are making a definitive crack into the mainstream media in terms of getting the rational and science-based side of the story regarding electronic cigarettes out to the public.

NPR Story on Electronic Cigarettes

Click here for the NPR story on electronic cigarettes, which aired on All Things Considered earlier today.

According to the story: "There is a split in the public health community over this question similar to the abstinence-only debate in sex education: whether to advocate that smokers switch to less harmful products, even if they are not completely safe."

"Boston University School of Public Health professor Michael Siegel says the FDA's recent consumer warning was misleading because the agency found low levels of carcinogens in e-cigarettes."

"It is comparable to what is present in nicotine-replacement products, which are on the market, and, in fact, if you look at the actual levels of the carcinogens in electronic cigarettes, they're about 1,400 times lower than in Marlboros," he says."

The Rest of the Story

This is really the first major national media outlet to present both sides of the story, so this is really an accomplishment for those of us fighting to present an appropriate perspective on the issue to the public. Hopefully, it will be the first of many stories to come.

Independent Scientific Review Concludes that NJOY Electronic Cigarettes are Much Safer than Conventional Ones

Report Also Concludes that FDA Failed to Adequately Support Claims of Dangers of NJOY E-Cigarettes Compared to FDA-Approved Nicotine Replacement Products

A new scientific report - commissioned by NJOY and conducted by Exponent, Inc., a scientific consulting firm - reviewed the FDA report and other studies of electronic cigarettes and concluded that the FDA failed to provide evidence that NJOY products are more dangerous than any FDA-approved nicotine replacement products currently on the market. The report also concluded that the FDA report actually confirms that NJOY electronic cigarettes are much safer than conventional ones and should therefore be welcomed rather than cause for concern.

Exponent Inc. is a large engineering and scientific consulting firm with substantial expertise in the areas of toxicology and mechanistic biology, including chemical risk assessment. Exponent has extensive experience in the development of toxicity criteria and safety levels for chemicals. Its analyses have been incorporated into risk assessments conducted by OSHA and the EPA, and its scientists serve on a number of expert government panels.

The report made a number of important points, many of which I have been making over the past two weeks:

• "In the lots that were tested by the FDA, none of the key chemicals of concern in this study such as TSNAs and tobacco-associated impurities were able to be quantifiably measured in the liquid of NJOY’s cartridges because they were all below the limits of quantification (LOQ)."
• "All of the tobacco-associated impurities found in the NJOY products were “present but at less than the level of the Nicotrol® inhaler [manufacturer] specification” according to the FDA report."
• "The chemical content of similar nicotine-containing FDA-approved products was not completely described with respect to the presence of tobacco-specific nitrosamines (TSNAs) and other tobacco-associated impurities that have also been found in nicotine replacement therapy (NRT) devices at similar, if not higher, levels."
• "Data presented in the report does not adequately support the opinion that users of NJOY products would actually be exposed to TSNAs and tobacco-specific impurities in the vapor phase during normal device use; and if exposed, that those levels would be a health concern as compared to other FDA-approved products."
• "The FDA-approved Nicotrol® inhaler was presented as a “control” for their studies, but was only used for some of the experiments. The device was never tested for the presence of the same “carcinogens and toxic chemicals” that were found in some of the e-cigarette cartridges. When it was indicated that the Nicotrol® inhaler device did contain some levels of tobacco associated impurities, it was never discussed in the report or even mentioned in the results section. These tobacco-specific impurities in the Nicotrol® inhaler were also not discussed in comparison to the values obtained for NJOY’s or Smoke Everywhere’s products. With respect to the TSNAs, the report did not mention that these substances are found in nicotine gum, the patch, nasal spray, and lozenges in concentrations that are at the very least similar to, or higher than those found in the NJOY cartridges (Stepanov et al. 2006; Osterdahl et al. 2004)."
• "Key carcinogenic and toxic chemicals that were found in the liquid phase were not examined in the vapor phase. From a human health exposure perspective, it would have been beneficial to determine if the same chemical constituents found in the liquid phase analysis were also found in the vapor phase, especially considering that the vapor phase is the pathway of exposure to the e-cigarette user."

The report concludes as follows:

1. "In summary, the report “Evaluation of e-cigarettes” suffers from several limitations, that taken together result in it failing to adequately support the FDA claims of potential adverse health consequences from the use of NJOY e-cigarette products tested as compared to other FDA-approved nicotine containing products."

2. "The detection of trace and non-measurable levels of TSNAs and tobacco-associated impurities in the liquid, rather than the vapor phase of NJOY’s products, at levels that are many orders of magnitude below conventional cigarettes, and at or below FDA-approved nicotine containing products, should be considered as indicators of the regulatory acceptability of the NJOY products rather than reason for concern. When considering the relative potential health risks posed by these trace levels, it is worth noting that the approved NRTs, which have been shown to contain these substances, were not judged to contain levels sufficient to warrant toxicity information or reference to these substances in their own product literature."

The Rest of the Story

This independent scientific report by an expert consulting firm in the area of toxicology and risk assessment confirms many of the critical points I have been making in commentaries over the past two weeks.

First, the FDA's presentation of its own laboratory results was very misleading because the Agency failed to mention the levels of the carcinogens that were detected in electronic cigarette cartridges (which were at trace levels) and failed to mention that these same carcinogens are also present (at similar trace levels) in FDA-approved nicotine replacement products.

Second, the FDA inexplicably failed to test the nicotine inhaler - which was the control device in the study - for the presence of the same carcinogens as in the electronic cigarettes. Such testing would likely have revealed the same trace levels of carcinogens, and would have nullified the FDA's and the anti-smoking groups' major points at the press conference.

Third, the FDA failed to compare the carcinogen levels in electronic cigarettes with those in real cigarettes which the FDA now approves. Such a comparison would have revealed that the real ones are 1400 times more dangerous. Thus, the FDA lab testing actually supports a conclusion that electronic cigarettes are much safer than the FDA-approved tobacco cigarettes and that electronic cigarettes should be embraced in the regulatory environment, rather than banned (as anti-smoking groups are widely calling for).

The Exponent report also notes that all of the NJOY electronic cigarette cartridges tested were negative for diethylene glycol. This suggests that propylene glycol cartridges that are derived from pharmaceutical grade propylene glycol are not a problem, and that the source of the problem with one electronic cigarette brand that contained diethylene glycol at a level of 1% is most likely the failure to use pharmaceutical grade propylene glycol, a problem that could (and should) be easily corrected.

The rest of the story is that an independent scientific expert report has now confirmed that - at least in the case of NJOY electronic cigarettes - there is no evidence that these products pose any increased health risks compared to FDA-approved nicotine replacement products and that they pose much less health risk than FDA-approved tobacco cigarettes.

Is it not inappropriate that while the FDA has had jurisdiction over both electronic cigarettes and tobacco cigarettes for the past several months, it has already held an alarmist press conference about the electronic ones, but has yet to put forward any warning to the public about the deadly real ones?

Inane Public Policy: Ban Electronic Cigarettes, and Approve the Real Ones

I have written extensively about the scientific and policy issues regarding electronic cigarettes in the past two weeks. But what it all really comes down to is this: it would be absurd for the FDA to ban electronic cigarettes at the same time that it approves the real ones.

Jacob Sullum, in a post yesterday on Reason Online's Hit & Run blog, points out the absurdity of what the anti-smoking groups are asking the FDA to do. He notes that these are supposed to be anti-smoking groups, yet they are asking the FDA to approve real cigarettes and ban the much safer electronic ones.

Sullum writes: "Last week Oregon Attorney General John Kroger bragged about successfully pressuring two travel store chains, Pilot Travel Centers and Travel Centers of America, to stop selling electronic cigarettes at their locations in the state. Action on Smoking and Health wants every attorney general to follow suit. "Until the FDA acts," says ASH Executive Director John Banzhaf, "it is appropriate for attorneys general to act to protect their health of their citizens." ... Deputy Attorney General Mary Williams explains the rationale for pulling e-cigarettes from stores: "When products threaten the health and safety of Oregonians, we will take action."...

"As Michael Siegel notes on his tobacco policy blog, however, Kroger's action does nothing about conventional cigarettes, products that "threaten the health and safety of Oregonians" much more than their smokeless competitors do. Tobacco cigarettes, after all, are now approved by the FDA, so they must be OK. It's a bit odd for an attorney general who claims to care about consumers' health (not to mention an anti-smoking group that is usually perceived as, you know, anti-smoking) to promote cigarette consumption by impeding access to an alternative that is far less hazardous. Like the FDA's threats to ban e-cigarettes, such policies reveal that "public health" often means pharmacological puritanism and regulation for its own sake, as opposed to health promotion."

The Rest of the Story

The irony of this story is that ASH, the Campaign for Tobacco-Free Kids, the American Heart Association, the American Lung Association, the American Cancer Society, and Americans for Nonsmokers' Rights are all promoting cigarette use by attempting to force electronic cigarette users to return to conventional tobacco cigarettes.

Have these groups not even considered the fact that:

(1) If electronic cigarettes are pulled from the market, hundreds of thousands of people will return to cigarette smoking; and

(2) By unduly scaring electronic cigarette users into thinking that these devices are as dangerous as cigarettes, they have already caused many vapers to return to smoking?

The combination of the passage of the FDA tobacco legislation and the anti-smoking groups' position on electronic cigarettes has led to an ironic and absurd situation where these anti-smoking groups have become promoters of Big Tobacco products. They are encouraging people to stay with, or return to, Marlboros, Camels, and Newports, rather than use a much safer alternative product that delivers nicotine without the 10,000 plus chemicals, toxins, and carcinogens.

Sadly, Sullum is right on the mark when he suggests that the anti-smoking groups are demonstrating "pharmacological puritanism and regulation for its own sake, as opposed to health promotion."

Oregon Attorney General Bans Electronic Cigarettes Because They Threaten the Health and Safety of Oregonians

Action on Smoking and Health Urges 49 Other Attorneys General to Follow Suit

The Oregon Department of Justice moved Thursday to ban the sale of electronic cigarettes in Oregon. The Department filed two settlements which prevent two travel store chains from selling electronic cigarettes.

According to an article on the KTVZ web site: "The Oregon Department of Justice filed two settlements Thursday that prevent two national travel store chains from selling "electronic cigarettes" in Oregon. The action is the first of its kind in the country and prevents Oregonians from buying potentially dangerous products that the U.S. Food and Drug Administration has yet to approve. "When products threaten the health and safety of Oregonians, we will take action," said Mary Williams, deputy attorney general. "If companies want to sell electronic cigarettes to consumers, they have to be able to prove they are safe." The affected travel store chains, Pilot Travel Centers, which has seven centers in Oregon, and TA Operating, which has four centers in Oregon, both sell "NJOY" brand electronic cigarettes. ... The settlement announced Thursday prohibits the sale of electronic cigarettes in Oregon until they are approved by FDA, or until a court rules the FDA does not have the authority to regulate electronic cigarettes."

The national anti-smoking group Action on Smoking and Health (ASH) issued a press release urging all 49 other Attorneys General to follow suit by also banning the sale of electronic cigarettes in their states. ASH warned the public about "the known dangers of electronic cigarettes."

According to the press release: "ASH, which in the past successfully urged state attorney generals to crack down on the illegal sale of cigarettes over the Internet, and to take action against the use of cartoon characters in cigarette ads, is providing the attorneys general with background information about the known dangers of e-cigarettes...".

ASH put forward a scientific argument that any reduced health risks resulting from the elimination of the toxins in tobacco smoke would only apply to cancer, not heart disease.

Specifically, ASH wrote: "Current smokers at elevated risk for cardiovascular problems may switch to e-cigarettes, thinking that they are far safer. But actually any decrease in health risk relates to cancer (since e-cigarettes reportedly contain far fewer carcinogens), and not to cardiovascular problems (as to which nicotine is the main culprit)."

The Rest of the Story

The rest of the story is that the Oregon Department of Justice is full of crap. They boasted to the public that "When products threaten the health and safety of Oregonians, we will take action." However, they announced no action last Thursday to protect the health and safety of Oregonians from the threat posed by tobacco cigarettes.

If the Oregon Department of Justice were honest in stating that whenever products threaten the health of Oregonians, they will take action, then they would certainly have taken action against the leading cause of preventable death in Oregon: tobacco cigarettes, which have been documented to kill more than 5,000 Oregonians each year.

Instead of having the courage, integrity, and honesty to tackle a proven health threat in the state of Oregon, the Department of Justice has chosen to ban a product which has not been documented to pose any substantial health risk to Oregonians, and which most likely is helping to avert significant disease and mortality in the state by keeping many of its residents off of cigarettes.

What the Oregon Department of Justice is saying is that they would rather have Oregonians smoke cigarettes -- with their more than 10,000 chemicals and 57 carcinogens -- than inhale electronic cigarette vapor, which has not been shown to deliver any of those 10,000 chemicals or 57 carcinogens in anything more than trace quantities.

From a public health perspective, this is the most absurd, non-science-based, and potentially damaging policy decision by a state government that I have witnessed in a long time.

ASH's petition to the other 49 states is equally absurd and non-science-based. However, what makes ASH's action even worse is that they are being dishonest in their presentation of the scientific facts. It is one thing to state its policy preference. But to present the Attorneys General with a serious misrepresentation of scientific facts - a severe factual inaccuracy in its assertion of the science - is unacceptable.

Specifically, ASH is being dishonest in its assertion that removing the tobacco-related chemicals from electronic cigarettes will only reduce cancer risk, not the risk of cardiovascular disease.

ASH asserts that nicotine is the main culprit of cardiovascular disease and that inhaling the nicotine without the 10,000 or more other chemicals will not reduce the risk of cardiovascular disease. This is demonstrably false. While nicotine is one chemical in tobacco smoke that is thought to contribute to the atherogenic properties of cigarette smoking, it is not the only one. Carbon monoxide, for example, is thought to contribute to cardiovascular disease. In addition, the particulate components of tobacco smoke almost certainly lead to an increase in cardiovascular disease risk. Moreover, smoking causes changes in cholesterol which increase heart disease risk but are almost certainly not attributable to the presence of nicotine.

This is not to say that removing the 10,000 or more chemicals in tobacco smoke - other than the nicotine - makes electronic cigarettes risk-free in terms of cardiovascular disease. But it does mean that electronic cigarettes do reduce the risk of heart disease compared with conventional ones. ASH's scientific claim in this case is baseless.

The fact that a baseless scientific claim is being used to support a policy action is much more problematic than if ASH were simply supporting a policy based on a strong theoretical argument that could be true. In this case, the argument is demonstrably untrue.

ASH's other major claim - that electronic cigarettes represent a known danger - is unsupported by scientific evidence. The only two pieces of information that have been put forward to support the claim that electronic cigarettes are a known hazard are: (1) the presence of carcinogens in e-cigarette cartridges; and (2) the presence of diethylene glycol in one cartridge.

However, the carcinogens are present in trace levels, lower than those allowed by the FDA in nicotine replacement products and 1400 times lower than the level in a Marlboro cigarette. There is no known danger of cancer at this low level of exposure.

The diethylene glycol has not been shown to actually be inhaled by the vaper. Thus, it remains to be seen whether this represents a known danger or not. More importantly, this contaminant was only found in one cartridge and there is no evidence that it is present in potentially dangerous quantities in the majority of cigarette brands. Diethylene glycol was not present in the cartridges of the e-cigarette brand which the Oregon Department of Justice removed from the market.

If ASH wants to talk about the potential dangers of electronic cigarette use, that's fair game; but to talk about the "known" dangers is disingenuous, if not an outright false representation of the science.

The only "known" danger of electronic cigarettes would be the possible risk of heart disease with long-term use. However, ASH and the Oregon Attorney General seem to have forgotten that these products are being marketed to cigarette smokers. So "known" dangers need to be interpreted in comparison to the "known" dangers of cigarette smoking. It simply cannot be contested that e-cigarettes are a much, much safer alternative compared to tobacco cigarettes. Even from the perspective of nicotine itself, which is delivered in much more potent doses in the conventional cigarette.

In President Obama’s inauguration speech, he promised to “restore science to its rightful place.” He was clearly making a promise that policy would be science-based, not driven by purely ideological tenets or political concerns. Through its action of banning electronic cigarettes but allowing the real ones to remain unscathed on the market, the Oregon Department of Justice is institutionalizing, rather than ending, the triumph of politics over science in policy making. This is not the way to restore science to its rightful place.

I'll close with the words of an electronic cigarette user in Oregon who summarizes the rest of the story better than I possibly can: "I live in Oregon. I use e-cigarettes, personal vaporizers. After smoking tobacco for over 35 years, I haven't had more than 10 tobacco cigarettes in the last 4 months. Now 'my' Attorney General wants to protect me by preventing me from using a device that allows me to use nicotine and nicotine only. He would rather I use tobacco and all its 4000+ carcinogens. I could do without that kind of protection."

To which I would respond: It's not health protection. It's politics.

List of Identified, Known Carcinogens in Electronic Cigarettes vs. Conventional Cigarettes, and Which Anti-Smoking Groups are Telling Smokers to Smoke

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.

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:

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
Newport (1)	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:

1. Stepanov I, Jensen J, Hatsukami D, Hecht SS. Tobacco-specific nitrosamines in new tobacco products. Nicotine & Tobacco Research 2006; 8:309-313. (Link)
   
2. Laugesen M. Safety Report on the Ruyan e-cigarette Cartridge and Inhaled Aerosol. Christchurch, New Zealand: Health New Zealand Ltd, 2008. (Link)
   
3. Wahlberg I. Tobacco-specific Nitrosamines in Unburnt New Zealand Tobaccos. Report to Health New Zealand Ltd. Swedish Match, 2004. (Link)
   

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.

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.

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:

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 jln-md@mindspring.com www.aaphp.org Brad Rodu Professor of Medicine Endowed Chair, Tobacco Harm Reduction Research University of Louisville Phone: 502-561-7273 Email: brad.rodu@louisville.edu http://rodutobaccotruth.blogspot.com Thomas R. Kiklas Director of Media inLife LLC Phone: 949-250-9600 x108 Email: tkiklas@myinlife.com

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?