My Appearance on WIBW's "On the Other Hand"

Click here to listen to my appearance on a segment on the Kansas smoking ban on WIBW radio's (Topeka) "On the Other Hand" with Raubin and Megan. You have to scroll down to "Friday's Show 2nd Hour."

Americans for Nonsmokers' Rights Using New Research on Thirdhand Smoke to Claim that Secondhand Electronic Cigarette Vapor is Hazardous

ANR Also Encouraging Anti-Smoking Groups to Disseminate Alarmist Claims About Dangers of Thirdhand Smoke

ANR is Claiming That Nicotine Was Previously Not Thought to Be Toxic

In a communication sent to smoke-free advocates across the country, Americans for Nonsmokers' Rights (ANR) cites the recent study on thirdhand smoke as evidence of the health hazards of secondhand exposure to electronic cigarette vapor.

Referring to the laboratory study published in the Proceedings of the National Academy of Sciences, which demonstrated that residual nicotine can react with ambient nitrous acid to form tobacco-specific nitrosamines, ANR writes: "It [the study] also validates concerns about the potential for health hazards from the use of e-cigarette products in enclosed spaces."

ANR also has prepared a sound bite which it encourages local anti-smoking groups to use with the media and the public in order to scare them about the hazards of thirdhand smoke: "While nicotine was previously thought to be a non-toxic substance, new research shows that when residual nicotine sticks to ordinary surfaces, it reacts with naturally occurring nitrous acid in the air, releasing a toxic soup of cancer-causing agents."

The Rest of the Story

The main importance of this story is that it demonstrates how the scientific integrity of ANR has completely disintegrated. I used to serve on the Executive Board of ANR and made great efforts to try to ensure that the organization adhered to the highest standards of scientific integrity and accuracy. I resigned from the Board after I was told that the organization's political credibility was more important than my scientific integrity.

You can now see how much ANR's scientific integrity has deteriorated since that time.

First, the thirdhand smoke study provides no evidence regarding the potential hazards of secondhand electronic cigarette vapor. ANR is making a completely unsupported extrapolation. There is no evidence that exhaled electronic smoke vapor contains significant amounts of nicotine or that such nicotine is deposited to any significant degree on surfaces, or that the quantity of any deposited nicotine is sufficient to result in significant nitrosamine formation.

The same claim could be made about nicotine inhalers. Using the level of scientific integrity that ANR is displaying here, one could say that the new thirdhand smoke study validates claims that the use of nicotine inhalers indoors should be banned because the exhaled air from users contains nicotine that will deposit and combine with ambient nitrous acid to produce a toxic soup of carcinogens.

I hope you see my point that this isn't science; this is hysteria.

Now to be sure, I am not disagreeing in any way with ANR's support for smoke-free workplaces. As you know, no one is a stronger supporter of smoke-free workplace laws - including smoking bans in bars, restaurants, and casinos - than I am. In fact, I was very critical of ANR for supporting the New Jersey law which banned smoking in all workplaces except casinos.

But I believe that one must support policies with solid scientific evidence.

The second element of ANR's lack of scientific accuracy is in its suggested sound bite - that thirdhand smoke is a "toxic soup of cancer-causing agents." We don't even have evidence that thirdhand smoke results in significant exposure among nonsmokers, much less that it is sufficient to cause cancer. If you're willing to make a statement like that based on the limited evidence currently available, then why require scientific evidence at all before disseminating alarmist health claims to the public?

A third element of ANR's lack of scientific accuracy is its assertion that nicotine was previously thought to be a non-toxic substance. What a damaging statement that is. It completely flies in the face of the scientific evidence we have about nicotine. And it runs counter to the overwhelming consensus of physicians and scientists throughout the country who warn their patients and the public that nicotine products are not "safe."

The FDA would cringe if it heard that ANR was telling people that other than the risks posed by conversion of nicotine to nitrosamines, nicotine is non-toxic.

Think about this: what ANR is actually asserting in its statement is that nicotine poses no danger to smokers. If the only toxicity related to nicotine is that when it deposits on surfaces it may be converted to nitrosamines, then the nicotine inhaled by smokers poses no danger.

While it may be news to ANR, nicotine is a highly toxic substance. Ingesting even small amounts of nicotine can kill you.

According to the EPA, ingestion or absorption of nicotine results in: "blockade of autonomic ganglia and skeletal muscle neuromuscular junctions, and direct effects on the central nervous system. Paralysis and vascular collapse are prominent features of acute poisoning, but death is often due to respiratory paralysis, which may ensue promptly after the first symptoms of poisoning."

So according to ANR, nicotine was not thought to be toxic prior to last month's study about thirdhand smoke. But according to the EPA, nicotine is in fact known to be potentially fatal.

So much for ANR's scientific integrity.

To be honest, even the tobacco industry has never had the gall to claim that nicotine is non-toxic, or was thought to be non-toxic prior to last month's research.

The rest of the story is that in its rush to create hysteria about thirdhand smoke, ANR has lost sight of even the most basic of scientific facts: that nicotine is highly toxic and has been known to be toxic for decades.

How could ANR possibly issue a statement to hundreds of public health practitioners throughout the country telling them that nicotine is a non-toxic substance (other than its implication in thirdhand smoke)?

I call on ANR to immediately issue a retraction and apology for lying to its constituents about the toxicity of nicotine. And I hope that in the future, ANR will renounce its current policy of placing politics ahead of science.

Anti-Smoking Advocate Reportedly Claims that Electronic Cigarettes are More Dangerous than Real Ones

According to an article in the Spartan Daily, the wellness and health promotion coordinator at San Jose State University is claiming that electronic cigarettes are more hazardous than actual cigarettes.

According to the article: "Electronic cigarettes may be more harmful and life threatening for those who choose to smoke them compared to an actual pack of cigarettes, said the wellness and health promotion coordinator at the Health Center. 'Many students don't know how much nicotine are in these e-cigs, and students don't know how harmful that can be,' Jennifer Gacutan-Galang said. What many students also don't know about the e-cig is that it is not FDA approved, she said. ... 'What the e-cig companies don't tell you is the amount of nicotine in each e-cig,' Gacutan-Galang said. 'Even though the e-cig does not have the 4,000 plus chemicals, they contain nicotine, which is the chemical that makes cigarettes addictive.' Gacutan-Galang said a student brought in an e-cig starter kit he had purchased from Valley Fair Mall and nowhere on the box or the pamphlet of the $120 product was the amount of nicotine printed."

The Rest of the Story

This is not only inaccurate information, it is also damaging. It sounds like the wellness coordinator is advising students to stick with regular cigarettes rather than switch to electronic ones. Her main concern seems to be that it is not known how much nicotine is in the electronic cigarettes. What she fails to understand, apparently, is that while the nicotine makes cigarettes addictive, it is the thousands of other chemicals that make these products highly toxic. How could inhaling nicotine plus more than 4,000 other chemicals be safer than just inhaling nicotine, even if you don't know exactly how much nicotine is being delivered?

The truth is that the nicotine delivery from electronic cigarettes has been tested in several studies and has been found to be far less than with regular cigarettes. So the rest of the story is that the advice this health and wellness coordinator appears to be giving to students is not only misinformed and wrong, but it is damaging to their health.

There is clearly something about the very idea of an electronic cigarette that bothers anti-smoking advocates. These products are very threatening to folks in the anti-smoking movement. My own opinion is that the main reason these products are so threatening is that anti-smoking advocates cannot accept the fact that going through the motions of a behavior that simulates smoking can possibly be condoned, much less recommended. The anti-smoking movement has completely lost sight of the best interests of the public's health and is instead blindly adhering to an ideology, without actually looking at the scientific evidence and without applying even the most basic of common sense.


(Thanks to VocalEK for the tip.)

My Appearance on the Jason Lewis Show

Click here to listen to my interview with Jason Lewis regarding the exaggerated and distorted scientific claims being made by the anti-smoking movement.

Please be patient - you need to listen to the commercial first, but then the show will begin. Also, he says my name wrong the first time but it is indeed me. Finally, I appear in the second half-hour of the show. The first issue discussed is the science of global warming. In my comments, I do make an analogy which ties together these two issues.

Harrassment of Smokers: Kimball Physics Will Not Allow a Smoker to Enter the Facility if They Fail the Sniff Test

Employees and visitors to Kimball Physics in Wilton, New Hampshire are greeted by a receptionist who administers the "sniff test." He or she smells you and if he or she can detect the smell of tobacco smoke - indicating that you have either smoked or been exposed to secondhand, thirdhand, or fourth-hand smoke, you are not allowed to enter the facility.

The official tobacco policy at Kimball Physics reads as follows: "Please note that Kimball Physics has some unusually strict tobacco policies. The policies were voted into existence by employee co-workers; and they apply to everyone."

"First: No tobacco use is allowed inside any Kimball Physics building or motor vehicle at any time. Further, no tobacco product is to be brought into any Kimball Physics building or motor vehicle at any time."

"Second: No tobacco use is allowed anywhere outside on Kimball Physics grounds (including entry areas, parking lots, picnic areas, grassed areas, fields, and hundreds of acres of woods). No tobacco use is allowed inside any motor vehicle, irrespective of ownership, while located on Kimball Physics grounds."

"Third: No tobacco-residuals emitting person, article of clothing, or other object is allowed inside any Kimball Physics building. This restriction also applies to anyone or anything emitting characteristic tobacco odors. Anyone who has used a tobacco product within the previous two hours is automatically to be turned away, unless measures have been taken such that residuals-sensitive persons are not exposed. The determining factor, regarding allowable residuals levels and/or exposure durations, is whether anyone is either significantly bothered, or even worse, made ill."

"Fourth: The policies apply to all. Policies are enforced by co-workers -- at the discretion of each individual co-worker. However, it is the responsibility of the controlling co-worker to minimize the exposure of residuals-sensitive persons. Tobacco policies are not enforced during emergency or crisis situations."

"BACKGROUND: What are tobacco residuals? Why do they matter? Tobacco combustion products do not suddenly disappear when a cigarette goes out. The chemical vapors and microscopic airborne particulates slowly dissipate, mostly by being blown away. However, fractions of these materials are trapped in a smoker's clothing, hair, lungs, etc., as well as on furniture, auto upholstery, and similar surfaces. Some of the vapors and particulates are then re-emitted over a period of hours (sometimes much longer). These re-emitted materials, plus any remaining not-yet-dissipated original smoke, are called tobacco residuals. The chemical composition of tobacco residuals is related to that of the original tobacco smoke, but at an intensity which is considerably reduced. Unfortunately, when a smoker (no longer smoking) moves to a new location, the tobacco residuals he emits are often of sufficient intensity to cause both health problems and annoyance to individuals at the new location. Conversely (as is widely accepted), if an individual enters an area formerly occupied by a smoker, a contaminated automobile for example, the same effects occur. This sensitivity, of course, explains the need for non-smoking hotel rooms, non-smoking rental cars, tobacco-free taxis, and the like. A surprisingly large fraction of the population is sensitive to tobacco residuals. Minor (and not so minor) illnesses which are caused by tobacco residuals include: headaches, stinging eyes, burning or constricting throats, chest congestion, hoarseness, coughing, nose bleeds, sinus problems, stomach pains, ear aches, asthma attacks, etc. The widely publicized tobacco-related major diseases like lung cancer presumably also occur at low exposure levels. However, they typically take decades to develop, affect only a minority of exposed persons, and have a causality which is hard to prove. The Kimball Physics policies are focused on lesser maladies, which occur in real time, where the cause-and-effect relationship is brutally clear, and where tobacco residuals are obviously the cause. Even if major illnesses were never encountered, it is simply not permissible to knowingly or carelessly make others sick, even mildly sick."

The Rest of the Story

This is getting ridiculous. It shows the kind of crazy policies that result from the anti-smoking movement's exaggeration of the science, especially with regard to the effects of what I am now calling fourth-hand smoke: the residuals that remain on the clothes, skin, and hair of a smoker.

While there are occasional individuals who are exquisitely sensitive and may experience a reaction to trace levels of certain chemicals - including tobacco smoke, perfume, or other chemicals - these can be easily dealt with on a case-by-case basis to ensure that they are protected. There is no need for such a blanket policy for the entire workplace.

Interestingly, this policy does not apply to perfume, which a small number of people are also sensitive to. In fact, the policy probably encourages smokers to use great quantities of perfume or other odor-hiding chemicals to make sure that they will be allowed entrance to the facility. Ironically, that could actually pose a risk to some very sensitive workers.

But the fact that perfume is not included should tell you that the real driving force behind this policy is not health protection, it is hatred of smokers.

Interestingly, a closer examination of the situation reveals that the policy was instituted by Dr. Charles Crawford, who was recognized for his efforts with the awarding of the 2007 American Lung Association/C. Everett Koop Unsung Hero Award. Dr. Crawford not only banned smoking inside the workplace, but anywhere on the grounds, including in the many acres of secluded woods on the property.

Apparently, that was to the liking of the American Lung Association; however, I fail to see how banning smoking in the many acres of secluded woods is necessary to protect nonsmokers from secondhand smoke exposure.

While I agree with Dr. Crawford's offering of financial incentives to smokers to quit smoking and with his creation of a smoke-free indoor workplace, I think the rest of his policies go too far.

Not surprisingly, it turns out that Dr. Crawford serves on the Board of Trustees of Action on Smoking and Health. So there is a direct connection between these draconian policies and the hysterical so-called "scientific" propaganda that is being spewed forth by ASH.

Action on Smoking and Health Promotes Hostility Toward Smokers, Calling Them Killers

In a press release issued in January 2009, Action on Smoking and Health (ASH) called smokers "killers" and promoted increasing hostility toward them.

The press release was entitled "Public growing increasingly hostile to smokers; no more privileges and toleration for polluters and killers, many say."

Among the "hostility" that ASH cites towards smokers are the refusal to hire smokers, firing smokers (even if they only smoke off the job), refusing to allow smokers to serve as adoptive parents (even if they agree to smoke only outside the home), and refusing to perform certain surgeries on smokers.

ASH states that smokers "kill thousands of their own children every year." The press release also equates smoking around children with "child abuse."

The Rest of the Story

This is just another piece of evidence that the anti-smoking movement has gone off the deep end and has shifted its battle from tobacco products and tobacco smoke to the smoker herself.

It is disgusting to compare sudden infant death syndrome with people "killing their own children." It is difficult for me to imagine how one could be less sensitive to people who have suffered such a tremendous tragedy.

The same goes with the comparison of smoking around children to child abuse.

I don't understand what is wrong with the anti-smoking movement. Not every group is saying these things, but very few groups are speaking out against them. In this case, silence is tantamount to condoning these statements. It is the silence of the movement that allows the extremist elements of the movement to take control. And frankly, I don't find too many anti-smoking groups that take issue with ASH's agenda and stance in the first place, although few are as vocal as ASH in expressing their views.

As someone who became involved in tobacco control specifically because I wanted to help smokers -- many of patients were smokers trying to quit -- I simply cannot understand or relate to a movement whose goal is now to punish, discriminate against, deny rights to, and promote hostility against smokers.

The movement is becoming so fanatical that it is now promoting policies that will actually do more harm than good.


(Thanks to Bill Gibson for the tip).

Action on Smoking and Health Cites Purported Hazards of Fourth-Hand Smoke to Promote Bans on Adoption of Children by Smokers

In a press release issued last Friday, Action on Smoking and Health (ASH) uses the purported effects of fourth-hand tobacco smoke to promote policies by which the adoption or fostering of children by smokers is not allowed, even if the prospective parents agree not to smoke inside the home.

To more accurately describe the important difference between two "new" types of tobacco smoke exposure, I am today introducing the term fourth-hand smoke to make an important distinction that has not heretofore been recognized.

Thirdhand smoke has been described as the off-gassing of residues that occurs after smoking has ceased in a room. In other words, if a smoker smokes inside a living room and then leaves for work, smoke residues that deposit on surfaces like the carpet and furniture in that living room can give rise to smoke chemicals via off-gassing. Nicotine residues and their chemical reaction products (such as tobacco-specific nitrosamines) can also be ingested by infants and young children. I will continue to refer to such exposures as thirdhand smoke.

However, "thirdhand" smoke has also been described in a different way. It has been described as also consisting of residues that smokers carry around with them and which can then give rise to chemical exposure even in rooms where smoking has never occurred. It is this exposure - which is one level removed from thirdhand smoke - which I will from now on refer to as "fourth-hand" smoke.

This distinction is a very important one. Thirdhand smoke only occurs in rooms where smoking occurs and is therefore of little to no consequence because nonsmokers will be exposed to the secondhand smoke in those rooms, which will dwarf any thirdhand smoke exposures. In contrast, fourth-hand smoke may occur in rooms or locations where smoking is never present, thus potentially resulting in meaningful exposure for nonsmokers.

The distinction is important, for example, in guiding parents as to whether smoking outside the home is enough to protect children. By smoking only outside the home, parents can ensure that there is no thirdhand smoke exposure. However, fourth-hand smoke exposure will still occur. This distinction is therefore important in evaluating policies that bar smokers from adopting or fostering children. If they agree not to smoke inside the home, there will be no thirdhand smoke exposure. But fourth-hand smoke exposure will still occur.

Nowhere is the distinction more important than in policy decisions about whether to allow smokers to take care of children, such as in schools and day care settings. If these smokers only smoke outside of the school or day care location, then there will be no thirdhand smoke. But fourth-hand smoke will still occur. So if fourth-hand smoke is a true and serious health hazard, then anti-smoking groups will have ammunition to promote policies that strip smokers of the right to teach in schools or work in day care facilities.

In its press release, ASH cites the effects of fourth-hand smoke in supporting policies that bar smokers from adopting children, stating that: "the invisible yet toxic brew of gases and particles clinging to smokers’ hair and clothing, has just been reported by researchers at Lawrence Berkeley Laboratory to combine with a common indoor air pollutant to form very potent cancer causing substances. This, the researchers say, places children at serious risk, even if parents smoke only outside the home, because they carry the residues inside with them."

"Dr. Lara Gundel, a co-author of this study just published in the Proceedings of the National Academy of Sciences warned: "Smoking outside is better than smoking indoors but nicotine residues will stick to a smoker's skin and clothing. Those residues follow a smoker back inside and get spread everywhere. The biggest risk is to young children. Dermal uptake of the nicotine through a child's skin is likely to occur when the smoker returns and if nitrous acid is in the air, which it usually is, then TSNAs [tobacco-specific nitrosamines] will be formed."

"Indeed, as another researcher has reported, thirdhand tobacco smoke is "much more toxic" than secondhand tobacco smoke because the aging of secondhand smoke absorbed on surfaces gives risk to new toxicants not present in fresh secondhand smoke."

"...a related study shows that the tobacco-residue chemicals in smokers’ breath were by themselves sufficient to cause or aggravate respiratory illnesses -- including asthma, coughs, and colds -- among children in smokers’ homes as compared with kids in homes with nonsmokers, even if the parents only smoked outside the home."

ASH goes on to state that smoking around children is "the most prevalent and dangerous form of child abuse."

The Rest of the Story

First of all, I find it disgusting to claim that smoking around children is the most "dangerous" form of child abuse. It is a disgraceful statement that completely undermines and salts the wounds of actual victims of child abuse.

To claim that smoking around children is child abuse is, in the first place, a disgraceful charge. To compare the intentional infliction of serious, immediate, and direct harm with what is in close to all cases not an intentional desire to harm anyone is disgusting and insensitive. It makes a mockery out of actual child abuse and I condemn the comparison in the strongest terms.

Second of all, there simply is no solid evidence that fourth-hand smoke exposure poses any substantial harm to the public, including children. There has yet to be a study in which significant exposure to toxic substances has been documented in a home that is known to be smoke-free. There is no evidence that the residues deposited on a smoker's clothing or hair or exhaled in their breath after smoking has ceased pose any significant danger.

In the absence of such evidence, it is untenable to support policies that prohibit smokers from adopting children, even if they agree to smoke only outside the home.

What ASH is essentially saying is that they would rather children remain in orphanages than be placed in a loving home if that loving home is being provided by a smoker, even if that smoker promises never to smoke in the home. Even if the smoker truly loves the child and would never cause harm to the child, ASH would rather the child remain in the orphanage. What if there is a shortage of adoptive parents (which there is in most places)? ASH would rather the children remain in the orphanage. This is a frighteningly disgusting policy that ASH is supporting. It is an anti-smoking policy that is truly going to cause substantial harm to children. And it is ironic that in the name of protecting children, ASH is supporting a policy that is going to cause severe harm to those very same children it claims to be trying to protect.

IN MY VIEW: Why Disseminating Unsupported Conclusions About Thirdhand Smoke Risks is So Irresponsible

Yesterday, I opined that it is inappropriate for researchers to disseminate unsupported conclusions about the risks that smokers pose to others in the household even if they only smoke outside the home. Today, I explain why I think spreading this undocumented information is irresponsible.

The Rest of the Story

Imagine, for a moment, that it were true that the mere presence of nicotine residue on the skin and clothing of a smoker posed a substantial health hazard to the people around them because of the formation of tobacco-specific nitrosamines to which nonsmokers could be exposed through dust inhalation (or in the case of infants - through dust ingestion and skin absorption). Suppose it were true that living with a smoker - even one who smokes only outside the home - posed a significant cancer risk. If this were the case, then the anti-smoking groups would have all the ammunition they need to push for policies to prohibit smokers from being day care providers or teachers. They would be able to argue that smokers should not be allowed in the workplace or public places because of the risks they pose to other people even if they are not actively smoking.

Even just focusing on the most vulnerable - infants and children - anti-smoking groups could make the argument that smokers should not be allowed to care for young children, either in day care settings or nursery school settings. They would also be able to argue that smokers should not be allowed to adopt or foster infants or young children, even if they only smoke outside of the home.

These are drastic measures that severely interfere with the freedom, autonomy, and rights of smokers. Surely, we would not want to impose such measures in the absence of definitive evidence that children are being substantially harmed by the tobacco-specific nitrosamines produced from nicotine residues resulting from deposition from the skin and clothing of smokers.

Unfortunately, the thirdhand smoke researchers have already disseminated - internationally - the conclusion that smokers pose a significant threat to infants and children even by their mere presence in the environment of these young people. Even if they do not smoke in their presence.

This is why it is so irresponsible to disseminate such conclusions without any evidence. The result is going to be actions that interfere with the freedom, autonomy, and rights of smokers, such as banning them from adopting or fostering children, prohibiting them from teaching or day care positions, or even barring them from the workplace entirely.

If you think I'm exaggerating, think twice. Anti-smoking groups are already supporting such policies and some of them have already been adopted. In fact, just this week a locality in Scotland prohibited smokers from adopting or fostering young children. Not only does this ill-advised policy unfairly trounce on the rights of smokers, but it also severely harms children by preventing or delaying their being placed with loving and supportive families. To do that on the basis of scientific evidence that is non-existent is criminal.

Action on Smoking and Health (ASH) is already pushing for policies that ban smokers from the workplace. ASH is already arguing that the exhaled breath of smokers is toxic and sufficient grounds to bar smokers from any workplace.

Already, there are newspaper headlines that read: "Third-hand Tobacco Smoke Causes Cancer." This is a hysterical claim, as even if we take the conclusions of the researchers as being true, it still doesn't prove that thirdhand smoke exposure causes cancer. Epidemiologic studies have not provided any evidence that childhood exposure to secondhand smoke exposure increases cancer risk. Nevertheless, these are the headlines that are spreading throughout the world because of the irresponsible and unsupported conclusions that are being disseminated by tobacco researchers.

The rest of the story is that it is irresponsible to disseminate conclusions that are not supported by any scientific evidence, especially if that information will be used to infringe upon the freedom, autonomy, and rights of individuals.

Researcher Warns that Smokers are a Danger to Their Children, Even if They Only Smoke Outdoors

As quoted in an article by the French news agency AFP, a co-author of the recent study regarding the risks of "thirdhand smoke" has warned that smokers represent a health threat to their children even if they only smoke outdoors because the residue on their skin and clothing is deposited in the home and leads to the formation of harmful levels of tobacco-specific nitrosamines, some of which are recognized as carcinogens.

Apparently, study investigators told the news agency that smoking outside the home does not mitigate the significant risk posed by thirdhand smoke. According to the article, Dr. Lara Gundel, a co-author of the thirdhand smoke study which was published in the Proceedings of the National Academy of Sciences stated: "Smoking outside is better than smoking indoors but nicotine residues will stick to a smoker's skin and clothing. Those residues follow a smoker back inside and get spread everywhere. The biggest risk is to young children. Dermal uptake of the nicotine through a child's skin is likely to occur when the smoker returns and if nitrous acid is in the air, which it usually is, then TSNAs will be formed."

The study itself was a laboratory study which found that residual nicotine from tobacco smoke that deposits on indoor surfaces can react with ambient nitrous acid to form carcinogenic tobacco-specific nitrosamines (see: Sleiman M, Gundel LA, Pankow JF, Jacob P, Singer BC, Destaillats H. Formation of carcinogens indoors by surface-mediated reactions of nicotine with nitrous acid, leading to potential thirdhand smoke hazards. Proceedings of the National Academy of Sciences 2010. Published online ahead of print).

The Rest of the Story

While the study documents that residual nicotine deposited on indoor surfaces is capable of reacting with ambient nitrous acid to form tobacco-specific nitrosamines that are carcinogenic, there is nothing in the study that allows one to conclude that substantial levels of nitrosamines are generated in the households of smokers who refrain from smoking inside the home.

The study cites evidence that nicotine surface concentrations ranging from 5 to 100 micrograms per square meter have been measured in cars and homes of smokers. The study itself documented the measurement of tobacco-specific nitrosamines in the truck of a driver who routinely smoked while commuting. However, the study does not cite evidence of nor measure the presence of tobacco-specific nitrosamines in environments that are documented to be smoke-free but which are frequented by smokers.

As I explained earlier, the key study - conducted by Matt et al. - failed to document the absence of smoking in households that were categorized as smoke-free by measuring ambient nicotine levels. Smokers are probably reluctant to admit that they smoke inside the home, so many of the reportedly smoke-free households were probably not actually smoke-free. Moreover, the study documented levels of nicotine that were not any higher than outdoor (background) levels in at least some households that were smoke-free, indicating that at least in some known cases, smokers who only smoke outdoors do not produce significant nicotine-laden residues in the home.

The study itself comes to a reasonable conclusion: that smokers should refrain from smoking inside the home in order to protect children in the home from exposure. However, the information provided by the co-investigator to the media is quite different. She is now suggesting that the study documents a risk to children even in smoke-free households if they live with a smoker. In other words, she is telling the public that if children live with a smoker, they are at risk from exposure to tobacco-specific nitrosamines even if that smoker smokes only outside of the household.

Moreover, she provides a detailed account of what she apparently knows to occur: "Those residues follow a smoker back inside and get spread everywhere. The biggest risk is to young children. Dermal uptake of the nicotine through a child's skin is likely to occur when the smoker returns and if nitrous acid is in the air, which it usually is, then TSNAs will be formed."

However, the study did not measure exposure to TSNAs among children at all. Nor did it measure the presence of nicotine in the households of smokers who only smoke outside of the home.

In other words, the study itself provides no evidence that "residues follow a smoker back inside and get spread everywhere" or that "dermal uptake of the nicotine" occurs in such situations or that "TSNAs will be formed."

The rest of the story, then, is that this researcher appears to be widely disseminating a conclusion that is not supported by any evidence. She appears to be misrepresenting the results of her own study to imply having demonstrated something that the study did not even measure.

If you are going to go to the extreme and tell the public that smoking outside the home still results in significant nicotine residues inside the home that then result in significant concentrations of TSNAs that are harmful to children, then you sure as heck better have some documentation that this is the case. At the very least, you ought to have evidence of substantial levels of nicotine on surfaces in homes where smoking has been clearly documented not to occur, but in which a smoker resides. Neither of these pieces of evidence have been provided in this case; thus, I view this investigator's apparent statements to the media to be not only unsupported by evidence, but also inappropriate and possibly damaging.

The damage is significant: smokers who believe that their smoking poses a risk to their children even if they smoke outside the home are much less likely to take the effort required to smoke outside the home. If I am a smoker and I find out that my efforts to protect my child from tobacco smoke are futile because I'm exposing them anyway by the nicotine that I'm dragging with me on my skin and clothing, then why bother going through the effort to refrain from smoking inside the home? And if I'm not able to quit (which 97% of smokers are not) and I decide to smoke inside the home, then the public's health is going to be harmed by this unsupported statement.

What's most problematic to me, however, is the fact that a conclusion would be drawn and disseminated to the public without any evidence and that the study is being misrepresented as having provided evidence for something that it did not even assess.

That is the real harm being done here. It is harm to science itself.

I think it sets a poor example to misrepresent research as having provided evidence for something that is not even assessed by that research. Why bother doing the research? If you are going to disseminate conclusions that were not tested in the research, then why not just disseminate those conclusions and save the expense of conducting the research?

If these researchers are interested in telling the public that smoking outside only does not mitigate the risks posed by TSNA exposure from thirdhand smoke, then do a study to determine whether or not when smokers smoke only outside the home, their homes are still contaminated with significant levels of nicotine residue.

If you're going to disseminate the conclusions without having even done the study, then what's the point of doing the research in the first place?

Kansas Senate Smoking Ban Bill Reeks of Hypocritical Double Standard

The Kansas Senate has passed legislation that would ban smoking in all Kansas workplaces, including bars and restaurants. However, the bill exempts casinos.

The Rest of the Story

The exemption is hardly a coincidence. The state now owns a casino and more are planned, as a 2007 law allows state-owned casinos.

Apparently, state policy makers think that secondhand smoke is a substantial public health hazard and no workers should be forced to be exposed to tobacco smoke, unless of course they are working in a casino which is bringing in profits for the state.

This double standard did not escape the attention of the editorial board of the Hutchinson newspaper, which exposed the hypocrisy of Kansas lawmakers.

Kansas now becomes an early front-runner for the 2010 Anti-Smoking Hypocrisy Award.

Action on Smoking and Heath Claims that Thirdhand Smoke is as Harmful As Active Smoking

In a press release issued last week, Action on Smoking and Health (ASH) claimed that thirdhand smoke - vapor released from cigarette smoke residue deposited during smoking but occurring after smoking has ceased - is as harmful as active smoking.

According to the ASH's statement: "Interestingly, another very recent study shows that nicotine exhaled into the air is converted by other common indoor air pollutants into cancer-causing chemicals which can linger on clothing, furniture, draperies, etc. -- a new risk being termed "thirdhand smoke" (www.pr-inside.com/rd-hand-smoke-study-has-legal-r1713633.htm). The risk could be comparable to that of smoking."

The Rest of the Story

Action on Smoking and Health's claim that thirdhand smoke is as dangerous as active smoking is a hysterical one, and it is unsupported by any scientific evidence.

But the problem is not simply that the claim is false. By claiming that thirdhand smoke is as dangerous as active smoking, ASH is also asserting that active smoking is no worse than minute exposure to the carcinogens present in thirdhand smoke. This statement completely undermines the public's appreciation of the hazards of active smoking. By equating the risks of active smoking to those of being in a room long after a smoker has been smoking, ASH is essentially telling smokers that the risks of their smoking have been greatly exaggerated.

Worse yet, ASH is destroying the scientific credibility of the anti-smoking movement and putting the movement at risk of losing the public's trust. The public is eventually going to view the anti-smoking groups as fanatics who have lost touch with reality and they are going to start rejecting everything that the anti-smoking movement claims - even those claims which are demonstrably true and important for the public to understand.

The anti-smoking groups are thus falling into the same trap that the public health groups fell into when spreading widespread hysteria about the swine flu pandemic. It's not that the pandemic is not a serious one (it has killed 12,000 people in the United States). It's that the hysteria spread by health authorities was so exaggerated that when the pandemic turned out not to be nearly as bad as predicted, the public lost confidence in the health authorities and rejected even the well-supported advice that swine flu is a serious problem and that everyone at risk should be vaccinated.

Vaccination rates for the swine flu are at unacceptably low levels specifically because the public lost confidence in the credibility of the health authorities. And those authorities lost their credibility specifically because they engaged in widespread, hysterical, over-exaggeration of the likely risks of the swine flu pandemic.

By going beyond the solid scientific evidence and by engaging in hysteria, the health authorities ended up making the pandemic worse than it would have been, because far fewer people were vaccinated than should have been. Had the health authorities simply spoken honestly about the very real and serious risks of swine flu, then people would not have experienced a disconnect between the health warnings and reality, and they would have continued to take the health groups' advice seriously.

I fear this is exactly what is going to happen with the anti-smoking movement. By engaging in hysterical claims that go far beyond the scientific evidence, the anti-smoking groups are going to lose the public's confidence. And when that happens, the public will stop believing anything that these groups have to say, even when those statements are valid and important for the public to understand.

Behavioral Pharmacology Laboratory Study of Electronic Cigarettes Finds Little Nicotine Delivery, But Some Suppression of Craving for Cigarettes

The first published study of the effectiveness of electronic cigarettes was released yesterday by Tobacco Control. The study, funded by the National Cancer Institute, was conducted by Dr. Thomas Eissenberg of the Virginia Commonwealth University Behavioral Pharmacology Laboratory.

In the study, 16 smokers abstained from smoking for at least 12 hours and then smoked either their own cigarette, a sham cigarette, or one of two brands of electronic cigarettes in a laboratory setting. Subjects were instructed to take 10 puffs on their cigarette and then their plasma nicotine levels and subjective measures of their craving for a cigarette were assessed for one hour. The experiment was then repeated with 10 more puffs on the cigarette.

There were two major findings.

First, both brands of electronic cigarette delivered little to no nicotine. The plasma nicotine levels among electronic cigarette smokers were hardly distinguishable from those of sham cigarette smokers. Mean plasma nicotine levels with the electronic cigarettes never exceeded 3.5 ng/mL, while mean nicotine levels with the sham cigarette were as high as 2.0 ng/mL and mean nicotine levels with regular cigarettes reached as high as 20.0 ng/mL.

Second, the electronic cigarettes were less effective than regular cigarettes in reducing cigarette cravings. One of the electronic cigarette brands failed to produce any significant reduction in craving. However, the second electronic cigarette brand appears to have reduced cigarette craving, an effect which was statistically significant in one of the two trials (the second one).

The paper concludes: "Relative to a tobacco cigarette, 10 puffs from either of these electronic nicotine delivery devices (E-cigarettes) with a 16 mg nicotine cartridge delivered little to no nicotine an suppressed craving less effectively."

Importantly, the paper notes that the number of puffs taken by the e-cigarette users was limited and thus may not simulate real vaping conditions, where vapers may take more puffs with greater intensity (i.e., puff volume).

As Dr. Eissenberg notes: "Importantly, these results were from two specific products tested under acute conditions in which puff number was controlled. Variability in product design may influence vapour content and chronic use and/or more intensive puffing (i.e., more puffs, greater puff volume) may influence nicotine delivery. Given these and other factors, there is an ongoing need to evaluate electronic nicotine delivery devices (E-cigarettes)."

The Rest of the Story

To me, the most remarkable finding of this study is that in at least one trial of one of the e-cigarette brands, there was a significant suppression of the craving for cigarettes despite the lack of any evidence of significant nicotine delivery.

This means that the behavioral stimuli alone (i.e., simulation of the act of cigarette smoking) were sufficient to reduce the craving for cigarettes, even without any significant level of nicotine being delivered.

As I discussed yesterday, there is previous research (also conducted by Dr. Eissenberg) which demonstrates the suppression of some smoking abstinence symptoms (most notably, the urge to smoke) by denicotinized cigarettes. Thus, it may be that the simulation of the act of smoking, which electronic cigarettes provide, can - in some situations - help suppress the urge to smoke. This might be an explanation for the anecdotal observation that many vapers have found electronic cigarettes to be helpful in allowing them to quit smoking and stay off cigarettes for long periods of time.

Of course, it is important to note that this study was conducted under laboratory conditions in which subjects were instructed to take 10 puffs. It is not clear what results might have occurred if smokers were permitted to smoke freely and as intensively as they desired. It is also possible that it takes some "practice" for vapers to be able to effectively obtain nicotine from electronic cigarettes.

For these reasons, the results of this study should be interpreted cautiously and this provocative research should stimulate further studies to help clarify the answers to these outstanding questions.

In summary, I believe that based on these research results, electronic cigarettes remain a very promising innovation that could potentially play an important role in promoting smoking cessation, especially in the absence of any effective alternatives. If it is true that these devices might even suppress the urge to smoke without delivering nicotine, then the possibility for a safe alternative to cigarette smoking may truly exist. Even if some delivery of nicotine is necessary, these devices could well present a safer alternative to smoking.

Further research on electronic cigarettes should now be a public health priority. Instead of banning these devices and relegating them to history, the FDA should embrace the possibility that these devices could make a miraculous contribution to smoking cessation and should actively help, and work with manufacturers and distributors to gather the evidence necessary to determine whether these devices can have an important role in the nation's smoking cessation strategy.

Research: Nicotine Alone is Not Enough to Treat Smoking Addiction; Behavioral Components Must Also Be Treated

Research Explains Why Electronic Cigarettes May Be So Effective in Promoting Smoking Cessation

According to research published in the 2005 issue of the journal Addiction, nicotine replacement alone is not enough to suppress all the symptoms of smoking abstinence; smoking-related stimuli may also be needed to successfully suppress the complete range of smoking withdrawal symptoms (see: Buchhalter AR, Acosta MC, Evans SE, Breland AB, Eissenberg T. Tobacco abstinence symptom suppression: the role played by the smoking-related stimuli that are delivered by denicotinized cigarettes. Addiction 2005; 100(4):550-559).

In the study, smokers were given either nicotinized cigarettes, de-nicotinized cigarettes, or no cigarettes and were monitored over a five-day period for a range of withdrawal symptoms. The key finding was that even in the absence of nicotine delivery, the smoking-related (behavioral) stimuli associated with the de-nicotinized cigarette were sufficient to suppress a number of the important symptoms of smoking abstinence, such as the urge to smoke.

The article summarizes the results and conclusion as follows: "Smoking-related stimuli are sufficient for suppressing some symptoms of tobacco abstinence over a 5-day period [i.e. Questionnaire of Smoking Urges (QSU) factor 1, 'Desire for sweets', 'Hunger' and 'Urges to smoke'], while in this study a combination of nicotine and smoking-related stimuli suppressed other symptoms (i.e. 'Difficulty concentrating', 'Increased eating', 'Restlessness' and 'Impatient'). These results indicate that, while some tobacco abstinence symptoms may be suppressed with nicotine, suppressing others may also require strategies that address the absence of smoking-related stimuli."

The article describes the implications of this research as follows: "Much research has been based on the assumption that nicotine dependence is responsible for all tobacco abstinence symptoms. The validity of this assumption is challenged by the fact that smoking-related stimuli alone—without nicotine—can suppress tobacco abstinence symptoms, at least for a 24-hour period. To the extent that non-nicotine, smoking-related stimuli alone can suppress tobacco abstinence symptoms indefinitely, the role of nicotine in treating these symptoms is uncertain."

The article notes that for specifically treating the urge to smoke that arises during abstinence from smoking, nicotine replacement therapy may be less effective than behavioral treatment: "When they [smokers trying to quit] complain of urge to smoke or increased hunger, behavioral techniques may be more helpful in symptom suppression than higher NRT doses."

The Rest of the Story

This research may help to explain the observation that electronic cigarettes seem to be effective in helping smokers achieve smoking cessation, even though results of a clinical trial using these products appear to find that at least some of these products may deliver very little nicotine.

The reaction of many anti-smoking advocates and researchers to the news yesterday that electronic cigarettes "don't deliver nicotine" was that these products are therefore not effective in treating smoking addiction and helping smokers quit. However, it may be that these researchers and advocates are overemphasizing the role of nicotine in suppressing the urge to smoke during smoking cessation attempts.

This research demonstrates that behavioral stimuli are not only important in suppressing smoking abstinence symptoms, but that for some symptoms - such as the urge to smoke - smoking-related stimuli may play a critical role. In other words, this research provides a strong theoretical foundation for the use of electronic cigarettes in smoking cessation, because it shows that the behavioral aspects of smoking alone - even in the absence of nicotine - can help to relieve the urge to smoke during smoking cessation.

The overemphasis on nicotine replacement therapy for treatment of "nicotine" dependence is no coincidence. I believe that the strong influence that Big Pharma money has had on the tobacco control movement has contributed to this apparent distortion of the role of nicotine compared to behavioral factors in maintaining smoking addiction. Not only are pharmaceutical companies funding many researchers in the anti-smoking movement, but the major tobacco control conferences - both national and international - are now sponsored by pharmaceutical companies. Moreover, the expert panel which recommended that nicotine replacement therapy be the mainstay of smoking addiction treatment was chaired by an individual who had a severe conflict of interest with Big Pharma, and at least seven of the expert panel members had conflicts of interest related to making money from pharmaceutical companies.

The rest of the story is that there is scientific research documenting that behavioral stimuli play a large role in the smoking addiction process. There is a theoretical rationale for why nicotine replacement alone would not be expected to fully suppress smoking abstinence symptoms. This research explains why electronic cigarettes represent such an important innovation in the treatment of smoking addiction. And the research might explain why electronic cigarettes appear to be so effective in helping smokers quit even though the devices may not actually deliver much nicotine.


(Thanks to Dr. Tom Eissenberg, the senior author of this study, for calling it to my attention.)

Reported Results of First Clinical Trial on Electronic Cigarettes Suggest that These Devices are Much Safer than Previously Thought

According to an article on the CNN web site, the results of the first clinical trial of electronic cigarettes are now available and the chief finding is apparently that the electronic cigarettes tested delivered almost no nicotine to users.

According to the article: "'Electronic cigarettes' that vaporize nicotine juice to inhale instead of smoke from burning tobacco do not deliver as promised, according to research at Virginia Commonwealth University. 'They are as effective at nicotine delivery as puffing on an unlit cigarette,' said Dr. Thomas Eissenberg, at the school's Institute for Drug and Alcohol Studies. His study, funded by the federal National Cancer Institute, is the first by U.S. doctors to check the function of so-called 'no-smoke tobacco' devices, which are unregulated in the United States for sale or use." ...

"The latest clinical evidence suggests users are not getting the addictive substance they get from smoking tobacco. 'These e-cigs do not deliver nicotine,' Eissenberg said of the findings he expects to publish in an upcoming issue of Tobacco Control, a product of the British Medical Journal Group. This past summer, Eissenberg recruited smokers without prior experience using e-cigarettes to volunteer to use two popular brands of the devices for a set period. The 16 subjects were regularly measured in a clinical setting for the presence of nicotine in their bodies, their reported craving for conventional cigarettes, and certain physiological effects such as a change in heart rate. 'Ten puffs from either of these electronic cigarettes with a 16 mg nicotine cartridge delivered little to no nicotine,' the study found."

The clinical trial is described here.

The Rest of the Story

If the findings of this study are accurate (and generalizable to other e-cigarette brands), then the major implication of this research is that electronic cigarettes are probably far safer than has previously been thought.

The major health concern related to electronic cigarettes is that they deliver nicotine, which is thought to contribute to cardiovascular disease, especially with long-term exposure. In addition, nicotine is highly addictive and its continued use leads to dependence, which is itself associated with negative consequences.

However, if this new research is accurate, then the main health concern associated with electronic cigarettes is actually much less of a concern than previously thought. If electronic cigarettes do not deliver much nicotine, then the problems associated with long-term exposure to, and dependence to, nicotine are ameliorated and no longer of concern.

In other words, if this research is accurate (and generalizable), then electronic cigarettes may not only be a safer alternative to smoking, they might actually be a safe alternative.

While I think this research demonstrates that at least two brands of electronic cigarettes do not appear to deliver much nicotine, these results conflict with some other laboratory findings, such as the finding that nicotine is present as 1.5% of the components in the vapor of inLife's Regal electronic cigarettes.

Thus, I do not think it is appropriate to conclude that all electronic cigarettes fail to deliver any nicotine.

But even if this research is only partially generalizable, the implications are enormous. Because what this work demonstrates is that it takes very little - if any - nicotine to satisfy the addiction to nicotine of smokers when they are provided with a mechanism that simulates all the other aspects of the smoking behavior.

In other words, if true, this research suggests that electronic cigarettes are really a miraculous innovation: a device that can simulate the smoking experience and get smokers off cigarettes, helping them overcome their nicotine addiction, without actually delivering much nicotine.

It appears that the role of nicotine in addiction to smoking has been exaggerated and that there are behavioral aspects to the addiction that play a very important role. It also appears that there is a very strong placebo effect and that even in the absence of nicotine, if smokers believe they are getting nicotine, it may go a long way towards satisfying their craving and ameliorating their withdrawal symptoms.

This has implications for research into the effectiveness of nicotine replacement products because it suggests that previous research is substantially marred by the failure to blind participants to their status. Subjects receiving placebo likely knew that they were not receiving nicotine; thus, they may easily have been discouraged and gone back to smoking. Even the marginal results of nicotine replacement therapy studies are now thrown into serious question.

Another important implication of this research is that - if generalizable to all e-cigarettes - it essentially eliminates any substantial concern about the health effects of these products on bystanders. With very little nicotine being delivered to the vaper, it is undeniable that there will simply be no significant exposure to nicotine among bystanders. Thus, the assertion of some anti-smoking groups that electronic cigarettes pose a threat to bystanders does not appear to be substantiated.

While we need to await the actual publication of these findings in a peer-reviewed journal, the preliminary indication is that electronic cigarettes are an incredible innovation: they are devices which appear to have great success in getting smokers off of cigarettes, yet they amazingly are able to do so without delivering much nicotine.

It may well be that electronic cigarettes are not dependent upon nicotine for their success. If so, this would mean that vapers could use glycerin or pure propylene glycol cartridges without any nicotine and still have success in overcoming their addiction to cigarettes. This would be truly a remarkable phenomenon, and it would represent an innovation with potentially immense public health benefits.

It would mean that a device which simulates smoking and delivers nothing but vaporized glycerin or propylene glycol could be effective as a smoking cessation aid. It would mean that, for the first time, we have a truly safe and potentially effective alternative to smoking.

Results of Electronic Cigarette Clinical Trial Announced

Check back later today for a commentary on the results of the first clinical trial of electronic cigarettes, the results of which were announced today. Full report to follow soon.

Utah's Proposed Action on E-Cigarettes Shows the Absurdity of the Anti-Smoking Movement's Entire Approach to Tobacco Policy

A bill approved Tuesday by a Utah state legislative subcommittee would ban electronic cigarettes and candy-flavored tobacco products. The only exception would be cigarettes or other tobacco products that are approved by the United States Food and Drug Administration (FDA).

According to an article on St. Lake City's ABC4 website: "Smoking is still legal in our state. But if you want to smoke e-cigarettes time could be running out. Today a House sub-committee approved a bill that would ban e-cigarettes, or electronic cigarettes, and any other flavored tobacco products including those that look like candy. The only exceptions would be products approved by the U.S. Food and Drug Administration."

The bill that was approved is the second substitute of Senate Bill 71, sponsored by Rep. Paul Ray (R-Clearfield). The bill now moves on to consideration by the full House.

The Rest of the Story

By "products that are approved by the U.S. Food and Drug Administration," what Utah legislators actually mean is the most irredeemably toxic products -- such as Marlboros, Camels, and Newports -- which we know are causing hundreds of thousands of deaths each year in the United States.

Ironically, it is now the case that the FDA has officially approved Marlboro, Camel, Newport, Winston, Salem, Virginia Slims and a host of other highly toxic cigarette products, while officially disapproving undeniably safer products, like electronic cigarettes, which deliver vaporized nicotine from a solution made up almost entirely of propylene glycol and nicotine.

What Utah is basically saying is: "We don't mind if you smoke, as long as you smoke the most deadly products available. The most highly toxic cigarettes are fine by us, but the clearly safer ones are not allowed in our state."

And the sad thing is - this is exactly what the anti-smoking movement is saying. The most deadly products - such as Marlboro, Camel, and Newport - are now FDA-approved and officially sanctioned by the FDA and the anti-smoking groups. But the products which are being used by smokers trying to quit their Marlboros, Camels, and Newports - namely, electronic cigarettes - are not recommended by the FDA and anti-smoking groups.

In other words, it is now the official policy of the government and the anti-smoking movement that they would prefer people continue to smoke the most highly toxic consumer products on the market, rather than make serious attempts to quit smoking by switching to a clearly much safer alternative that contains no tobacco and for many brands, has been demonstrated not to deliver any tobacco-specific nitrosamines.

In other words, the anti-smoking movement wants smokers to smoke cigarettes with documented high levels of proven, potent carcinogens like NNN (N-nitrosonornicotine) and NNK (nitrosamine 4-(methylnitro-samino)-1-(3-pyridyl)-1-butanone), rather than switch to a product which has helped thousands of people quit smoking and has been demonstrated not to contain anything more than trace levels of carcinogens, including no detectable NNN or NNK in at least several brands.

The basic policy of the anti-smoking movement, then, is exactly the opposite of what it should be. Rather than encouraging smokers who have already quit smoking by using a much safer alternative - a non-tobacco product, the movement wants them to be forced to return to inhaling high concentrations of NNN and NNK.

I honestly never dreamed of seeing this day. An absolutely shocking turn of events in tobacco control. We are now promoting disease and death and trying to inhibit people - or to outright prevent them - from taking action to protect their health and possibly save their lives.

And it's all because the anti-smoking groups can't stand the idea that a person might actually go through the motions of what appears to be cigarette smoking.

It's no longer about the science or even about the public's health. It's purely about the promotion of a narrow-minded ideology.

FDA Appeals District Court Decision to Issue Injunction Against Regulating Electronic Cigarettes as Drugs/Devices

The Food and Drug Administration (FDA) has appealed a district court decision that I reported here in which Judge Richard J. Leon issued a preliminary injunction blocking the Agency from enforcing its asserted regulatory authority over electronic cigarettes as drugs/devices under the Federal Food, Drug, and Cosmetic Act.

According to an article in the Wall Street Journal: "The Food and Drug Administration is appealing a federal judge's ruling that the agency doesn't have the authority to regulate electronic cigarettes. The FDA on Monday night asked a federal appeals court in Washington to immediately stay an order that prevented the agency from blocking electronic cigarettes from entering the country. The FDA said it does have the authority to regulate some products containing nicotine as though they are drugs and devices, such as nicotine patches and nicotine lollipops. The agency said the judge was 'quite wrong to believe that no injury would result from the use of these harmful and addictive products.'"

The Rest of the Story

Readers should first of all understand that success for the FDA in this particular appeals case would not necessarily mean that the Agency has the authority to regulate electronic cigarettes as drugs/devices. The Appeals Court could overturn the preliminary injunction on two grounds: (1) finding that there is not a high likelihood of success of the legal challenge against FDA regulatory authority over electronic cigarettes under the Food, Drug, and Cosmetic Act; or (2) finding that an injunction against the FDA's ability to take e-cigarettes off the market would cause severe public health injury that outweighs the immediate economic harm that would be suffered by e-cigarette companies.

The issue of whether the FDA has the authority to regulate electronic cigarettes as drugs/devices, given the language of the recently enacted Family Smoking Prevention and Tobacco Control Act - which defines tobacco products as any products "derived from" tobacco - is a complex one and it will be interesting to see how the appeals court rules on that issue. That aspect of the ruling will provide a relatively good sense of how the issue will ultimately be disposed.

The issue of whether taking e-cigarettes off the market is necessary to prevent severe public health harm, however, is not one that is in any way unclear. I strongly disagree with the FDA's assertion that removing e-cigarettes from the market will protect the public's health. To the contrary, I believe that removing e-cigarettes from the market will cause severe and irreparable public health harm.

Why? Because a huge number of e-cigarette users are ex-smokers who have quit smoking successfully using these products. To deprive them of the choice to continue vaping an instead, force them to return to smoking, would severely harm their health. I simply do not see the public health protection resulting from a policy of forcing thousands of vapers to return to cigarette smoking.

While it remains to be seen whether the FDA has a valid legal argument on the first issue, I am sorry to say that on the second issue, the FDA has an invalid scientific argument.

Boston University School of Public Health Symposium on Tobacco Regulation and the FDA Now Available for Viewing

Is there such thing as a "safer" cigarette? What are the public health implications of the FDA's new regulatory authority over tobacco products? Should electronic cigarettes be banned or promoted?

These are just a few of the questions that were addressed at the 2009 William J. Bicknell Lectureship in Public Health held at Boston University School of Public Health on Friday, Oct. 23, 2009.

The keynote speaker of the event was Dr. Gregory Connolly, Professor of the Practice of Public Health at the Harvard School of Public Health. Dr. Connolly is a world-renowned expert on the control of tobacco products - including both cigarettes and smokeless tobacco - and was awarded the Surgeon General's Medallion by Dr. C. Everett Koop for his work in passing the Comprehensive Smokeless Tobacco Health Education Act. Before coming to Harvard, he served for many years as the director of the Massachusetts Tobacco Control Program, during a time in which the Commonwealth experienced a precipitous drop in cigarette consumption, both among adults and youths.

The panelist speakers at the event included myself, Patrick Basham (the founding director of the Democracy Institute and author of a book published recently, entitled "Butt Out! How Philip Morris Burned Ted Kennedy, the FDA & the Anti-Tobacco Movement") and Dr. Cheryl Healton (the founding president and chief executive officer of the American Legacy Foundation).

To watch the video of the event, click here.

Philip Morris Has Also Publicly Disclosed Its Brand-Specific Ingredients; FDA Tobacco Law Adds Nothing

I reported last week that R.J. Reynolds has publicly released its full list of cigarette ingredients by brand, along with the maximum quantities of each ingredient present in its cigarettes. Today, I report that Philip Morris has also released a brand-by-brand account of its cigarette ingredients and maximum quantities present.

For example, we now know that the ingredients of Marlboro 100's are:

• Tobacco
• Water
• Sugars (Sucrose and/or Invert Sugar and/or High Fructose Corn Syrup)
• Propylene Glycol
• Glycerol
• Licorice Extract
• Diammonium Phosphate
• Ammonium Hydroxide
• Cocoa and Cocoa Products
• Carob Bean and Extract
• Natural and Artificial Flavors

The Rest of the Story

Contrary to the public propaganda statements of the Campaign for Tobacco-Free Kids and other health groups, the FDA tobacco law adds virtually nothing that we don't already know about the ingredients of cigarettes. Both R.J. Reynolds and Philip Morris have already revealed their brand-by-brand ingredient lists, along with the maximum concentration of each ingredient present. The complete list of known tobacco smoke constituents has also been published. Thus, the FDA tobacco law adds nothing new.

More importantly, what use is having this ingredient list? It's not like we don't already know why cigarettes are dangerous. Looking at the ingredient list of Marlboro 100's, is there any doubt as to why this product is deadly? I suspect it's not the water, natural or artificial flavors, sugars, propylene glycol, glycerol, licorice, cocoa or carob bean. While the ammonia alters the pH of the product to enhance the nicotine delivery, taking it out is not going to make Marlboro 100's any safer. My best guess is that what makes Marlboro 100's so deadly is the first listed ingredient: the tobacco.

Do we really need bureaucrats at the FDA poring through lists of all these cigarette ingredients, wasting taxpayer dollars only to conclude that cigarettes are toxic because they contain tobacco?

And even if some of the added ingredients make cigarettes more addictive by enhancing nicotine delivery, no one in their right mind would contend that eliminating all of these ingredients, and allowing the tobacco companies to provide their customers with pure tobacco (as Winston and American Spirit already do) is going to make cigarettes safer.

If the Campaign for Tobacco-Free Kids really maintains that eliminating certain cigarette ingredients is going to make cigarettes safer and benefit the public's health, then the Campaign must also argue that Winston and American Spirit cigarettes are safer and confer public health benefits to the population. I doubt that the Campaign is willing to make such an assertion.

Once again, the Family Smoking Prevention and Tobacco Control Act, is largely a piece of political propaganda, designed to allow policy makers and health groups to boast that they have taken on the tobacco companies when in fact, they have done nothing substantive to address the problem of tobacco use.


(Thanks to EinsteinSmoked for the tip).