Monday, August 31, 2015

Anti-Smoking Groups' Campaign of Deception is Working: Inquisitr Article Copies 7 E-Cigarette Myths Almost Verbatim from E-Cigarette Opponents

An article published yesterday at Inquisitr purports to present seven reasons why e-cigarettes are "bad."

Here they are:

1. The effects of e-cigarettes are nowhere near as well-documented as cigarettes.
2. E-cigarettes contain plenty of cancerous chemicals. 
3. E-cigarettes are just as addictive as smoking tobacco. 
4. E-cigarettes have negative effects on lungs. 
5. E-cigarettes won’t help you quit.
6. E-cigarettes create the equivalent of secondhand smoke.
7. E-cigarettes are a gateway into tobacco products for youth. 
 
The Rest of the Story
 
The rest of the story is that most of these seven claims are false, all are misleading, all seven points actually demonstrate the public health value of e-cigarettes, and all seven arguments are taken almost verbatim from the propaganda being disseminated by colleagues of mine in the anti-smoking movement, demonstrating that their campaign of deception regarding e-cigarettes is working.
 
While the presence of this misleading information on one internet news site may not be terribly significant, the story is quite significant because it demonstrates that the false and deceptive information being disseminated by anti-smoking groups and health agencies which oppose e-cigarettes (including the CDC and the California Department of Public Health, as well as the American Lung Association) is being accepted at face value by the media and is therefore being spread to the public uncritically.
 
Here is the truth about each of the seven claims:
 
1. The effects of e-cigarettes are nowhere near as well-documented as cigarettes.
 
That's exactly the point! While cigarette smoke is known to contain more than 10,000 chemicals, including more than 60 known human carcinogens, and while smoking is known to kill hundreds of thousands of Americans each year from cancer, heart disease, emphysema, stroke, and numerous other diseases, electronic cigarette vapor has been documented to only produce a small number of chemicals, most at low levels, is not known to cause any major adverse health effects, and based on the existing studies, vaping is much safer than smoking, does not appear to cause any major acute problems, and at worst, may present mild risks if used regularly for many years. But those risks are certainly dwarfed by the risks of continuing to smoke. And, it is not yet clear whether vaping is a behavior that is likely to be maintained for decades, as we know smoking is. 
 
So this argument is quite misleading, since it actually supports the idea that vaping is much safer than smoking and therefore, that smokers who are able to quit smoking by switching to e-cigarettes are doing themselves a great favor by substantially improving their health and perhaps saving their lives. In fact, several studies (not mentioned in the article and never cited by the anti-smoking groups which oppose e-cigarettes) document that smokers who switch to e-cigarettes experience an immediate improvement in their respiratory symptoms and lung function, including a reduction in airways resistance.
 
2. E-cigarettes contain plenty of cancerous chemicals. 
 
So does city air. The issue is how the carcinogenic profile of e-cigarettes compares with that of tobacco cigarettes. We know conclusively that it is possible to produce e-cigarettes with no more than trace levels of any carcinogen, and several major brands of e-cigarettes (including those produced by the tobacco companies) have been documented not to contain no more than trace levels of any carcinogen. Even in e-cigarettes that have inadequate temperature regulation, there are only one or two carcinogens of concern (primarily formaldehyde), and it is not clear whether they confer any carcinogenic risk. Without a doubt, however, all of these products greatly lower a person's carcinogenic risk compared to smoking.
 
3. E-cigarettes are just as addictive as smoking tobacco. 
 
This is simply false. A number of studies have shown that e-cigarettes do not carry the same addictive power as tobacco cigarettes. The primary reason for this is that the nicotine delivery during vaping is much less effective than that during smoking.
 
4. E-cigarettes have negative effects on lungs. 
 
It is not clear whether these "negative" effects have any clinical meaning. While vaping does lead to a slight increase in airways resistance, the changes are transient, and it is not clear whether there is any long-term risk. What is clear, however, is that switching from real cigarettes to e-cigarettes has almost immediate positive effects on respiratory function and health.
 
5. E-cigarettes won’t help you quit.
This is also untrue. Electronic cigarettes have helped literally thousands of smokers in the U.S. quit successfully. Moreover, the long-term quit rates with electronic cigarettes - based on existing clinical trials - appear to be at least as high as with FDA-approved drugs.

6. E-cigarettes create the equivalent of secondhand smoke.
 
This is false. There is no smoke produced by e-cigarettes because there is no combustion. The "secondhand vapor" created by e-cigarettes (which is simply the exhaled air from the vaper) is much safer than secondhand smoke and it is not even clear that it poses any substantial health hazards to bystanders.
 
7. E-cigarettes are a gateway into tobacco products for youth.
 
This is also false. There is no evidence to support this claim, and all of the existing evidence points in the other direction, E-cigarettes are not a gateway into tobacco-containing products for youth and in fact, they appear to distract kids away from tobacco cigarette smoking by presenting a safer alternative. 

Public Health Implications
 
Unfortunately, the public health implications of the campaign of deception being waged by e-cigarette opponents are quite negative. The campaign is undermining years of public education about the severe negative health impact of smoking. It is deceiving people into thinking that smoking is no more dangerous than using a non-tobacco-containing product which is not combusted. It is discouraging smokers who might otherwise have quit from even trying to quit. And it is causing many ex-smokers to return to smoking, thinking that there is no benefit to vaping over smoking so what's the point of remaining off of cigarettes.

Wednesday, August 19, 2015

U.S. District Court Decision May Cast Doubt on Constitutionality of FDA's Upcoming E-Cigarette Regulations

A recent decision by a U.S. District Court (for the Southern District of New York) casts serious doubt on the constitutionality of the soon-to-be-released FDA deeming regulations for electronic cigarettes.

The ruling involved the question of whether drug companies may promote their products for off-label uses if such statements are factual and not misleading. The decision, explained in detail here, held that the FDA cannot prosecute a drug manufacturer for marketing a "misbranded" product based solely on the promotion of that drug for off-label purposes. The court ruled that such a prosecution would violate the First Amendment rights of the company, so long as it is making factual and non-misleading statements about the off-label uses.

Specifically, such a prosecution would not meet the third and fourth prongs of the Central Hudson test. First, it would not advance the government's interest in ensuring accurate communication to consumers because banning truthful, non-misleading statements does not advance such a purpose. Second, it violated the fourth prong of Central Hudson because the prohibition is far broader than necessary to advance the government's interest in ensuring that the information given to consumers about pharmaceutical products is accurate and non-misleading.

The Rest of the Story

This case has important potential implications for the e-cigarette deeming regulations that I expect the FDA to release shortly. Specifically, the case casts doubt on the constitutionality of what I expect will be the application of the modified risk provisions of the Family Smoking Prevention and Tobacco Control Act (section 911) to electronic cigarettes.

Should the FDA take such an action, it would mean that no electronic cigarette company could even mention to its customers that the product does not contain tobacco, or even that it does not produce smoke. Such statements would render the products to be "reduced exposure" products and would require pre-approval from the FDA. Section 911 clearly specifies that if a company suggests that its tobacco product does not produce a particular substance or is free of a substance contained in another tobacco product, then it is making a reduced exposure claim, which is not permissible without pre-approval.

Obtaining such approval would be impossible because the company would have to show that consumers do not infer that not containing tobacco or not producing smoke means that the product is likely safer than real tobacco cigarettes. Obviously, consumers are going to correctly infer that the absence of tobacco and combustion does indeed make e-cigarettes safer. Since these reduced exposure claims could never gain approval, the deeming regulations would essentially ban companies from making these truthful, non-misleading statements.

However, under the reasoning expounded in the New York district court decision, such a prohibition would likely be viewed as violating the free speech rights of the e-cigarette companies because it fails to satisfy the third and fourth prongs of Central Hudson. No government interest is advanced by forcing companies to essentially lie about the two most important features of their products: (1) the absence of tobacco; and (2) the absence of smoke (i.e., combustion). Prohibiting such truthful and non-misleading speech does nothing to advance the government's interest in ensuring that consumers receive accurate and non-misleading information about the safety or relative safety of different tobacco products.

In fact, such a prohibition would make it impossible for companies to truthfully and accurately communicate to consumers the relative safety of electronic cigarettes compared to tobacco cigarettes, which would essentially ensure that consumers are deeply misled about the relative safety of these two different types of "tobacco products." Thus, the prohibition not only fails to advance the government's purpose, but it directly contravenes that purpose. This would likely be viewed upon as a particularly unjustified intrusion into commercial free speech.

The rest of the story, then, is that I believe that the FDA's deeming regulations will be challenged successfully in court on the grounds that section 911, as applied to electronic cigarettes, infringes upon the free speech rights of electronic cigarette companies.

Tuesday, August 18, 2015

According to Campaign for Tobacco-Free Kids, New Study Suggests E-Cigs are a Gateway to Smoking

A new study published moments ago in JAMA reports the results of a one-year longitudinal follow-up study of 9th graders in Los Angeles schools who did not smoke cigarettes at baseline. Among the 9th grade students who had ever tried an electronic cigarette at baseline, the odds of progression to smoking initiation were 2.7 times higher than among students who had never tried an electronic cigarette. Importantly, the study defined smoking initiation as any cigarette use (even just a single puff).

(See: Leventhal AM, et al. Association of electronic cigarette use with initiation of combustible tobacco product smoking in early adolescence. JAMA. Published online ahead of print on August 18, 2015.)

Within hours of the release of the JAMA study, the Campaign for Tobacco-Free Kids issued a press release arguing that these data suggest e-cigarette use is "a gateway to use of other tobacco products, including regular cigarettes" and that "use of electronic cigarettes by youth who had not previously smoked could lead to use of cigarettes. ..." 

The press release closes by stating: "We cannot allow the tobacco industry to keep addicting kids and create another epidemic with a new generation of tobacco products."

The Rest of the Story

The rest of the story is that the Campaign for Tobacco-Free Kids is being too hasty in jumping on this study as providing evidence that e-cigarettes are a gateway to smoking. The study shows nothing of the sort, and the authors and commentators readily acknowledge that. Apparently, the Campaign is so anxious to demonize e-cigarettes and to support its pre-determined conclusions that it is willing to throw rigorous scientific analysis out the window when it sees an opportunity to pounce on a good headline.

There are three huge limitations of the study which make it essentially irrelevant to the question of whether e-cigarette use leads kids to start smoking. First, the study did not measure "e-cigarette use." It merely asked kids whether they had "ever" tried an e-cigarette. Kids who had ever tried an e-cigarette, even a puff, where compared with all kids who had never even puffed on an e-cigarette.

You can immediately see the problem here. Kids who would not even try an e-cigarette, despite their popularity, represent a different population than kids who would try a puff on an e-cig. Of course the subsequent smoking rates are going to be higher among the kids who were susceptible to trying the e-cigarette. There is really no news here. This is a phenomenon which has already been documented in the literature.

The second problem is that the study failed to document that any of these kids actually used e-cigarettes regularly and became addicted to them before proceeding to use real cigarettes. All the study documented is that these kids had tried e-cigarettes at least once. The study simply cannot infer that these students became regular users of e-cigarettes, that they became addicted to e-cigarettes, or even that they ever tried an e-cigarette again.

Third, the study defined smoking as any use of a cigarette, even a puff. Thus, even among the youth who supposedly initiated smoking, we don't know that they actually became smokers. They may simply have tried a puff on a cigarette and decided it was not for them. In fact, it is entirely possible that they tried a puff on a cigarette, decided that the e-cigarette was much better tasting, and that they chose to vape instead of smoke. In this way, e-cigarettes could have actually served as a deterrent to smoking among this population.

Ultimately, what this research demonstrates is that youth who experiment with electronic cigarettes represent a sub-population of youth which is at increased risk of tobacco product use. This is a natural finding that we expected to be true and which has been documented in other studies. The study does not show that e-cigarette use leads kids to start smoking or to become regular smokers. It does not demonstrate a gateway effect.

The study authors readily acknowledge this, with the lead author making it clear that: "we cannot conclude that e-cigarette use directly leads to smoking."

The accompanying editorial makes the same point, even more clearly: "Because the only outcome measure was any use of a tobacco product during the past 6 months, the analysis could not distinguish students who had just tried a few cigarettes from those who progressed to regular smoking during follow-up. The latter is the greater concern, and the current study cannot determine whether e-cigarette exposure was associated with that outcome."

Nevertheless, these cautions did not prevent the Campaign for Tobacco-Free Kids to draw its own conclusion - apparently a pre-determined one - that e-cigarettes are leading youth to try real cigarettes and to become addicted to them. Apparently, the Campaign for Tobacco-Free Kids doesn't need actual evidence to draw scientific conclusions; it just needs any potential headline that it can pounce on. That's exactly how I would describe the tobacco industry's behavior historically.

To make matters worse, the Campaign for Tobacco-Free Kids misleads the public by calling e-cigarettes "tobacco products," despite the fact that they contain no tobacco. And, it attacks the tobacco companies for addicting kids to e-cigarettes when it is not even clear whether or not any nonsmoking youth are addicted to e-cigarettes and if any are, it is not clear that any tobacco company e-cigarette brands are involved. After all, maybe it is the "gummy bear and cotton candy" brands (not manufactured by Big Tobacco) which are the ones implicated in the rapidly increasing rates of smoking that have been observed among America's youth contemporaneously with the dramatic rise in e-cigarette experimentation.

Check that. There are no rapidly increasing rates of smoking that have been observed among America's youth contemporaneously with the dramatic rise in e-cigarette experimentation. It is rapidly decreasing rates of smoking.

Monday, August 17, 2015

Indiana Health Official Spreads Massive Lie Among Public, While Another Study Refutes the Gateway Hypothesis

According to a public health official in Indiana, it is just as safe to smoke a cigarette as it is to vape an electronic cigarette.

According to an article in the South Bend Tribune, the executive director of the Indiana Prevention Resource Center stated: "What we can gather is that students have this misconception it’s somehow safer than smoking a cigarette. I think the tobacco industry is really intentionally marketing e-cigarettes that way to make them appear, kind of by implication, that they’re safer than smoking a cigarette."

The statement was made in the context of the release of a new survey, which showed that despite widespread use of electronic cigarettes among Indiana teenagers, fewer and fewer teens are smoking tobacco cigarettes.

According to the Indiana Youth Survey, as many as one-fourth of all high school seniors in Indiana were "current users" of electronic cigarettes in 2015, defined as having used electronic cigarettes at least once in the past 30 days. Despite this high prevalence of e-cigarette use, the proportion of high school seniors who reported smoking dropped from 17.6% in 2014 to 16.2% in 2015.

In fact, the rapid proliferation of electronic cigarette use among youth in Indiana, which occurred chiefly between 2011 and 2015, coincided with a dramatic decline in smoking during the same period. Smoking among high school seniors in Indiana, for example, declined from 24.6% in 2011 to 16.2% in 2015, about a 33% reduction. Prior to 2011, smoking had not declined at all during the previous four years.

The Rest of the Story

The Indiana Youth Survey adds to the evidence that e-cigarettes are not serving as any major gateway to cigarette smoking among youth. With experimentation rates as high as 25% among high school seniors, it is just not consistent with the gateway hypothesis that we would continue to see dramatically declining smoking prevalence in the face of this massive experimentation with e-cigarettes if e-cigarette experimentation were truly serving as a gateway to cigarette smoking.

But the real story here is not merely the release of these new data. The real story is that this is another example of public health officials lying to the public about the relative health effects of smoking compared to vaping. Here, the Indiana Prevention Resource Center is telling the public that smoking cigarettes is every bit as safe as experimenting with e-cigarettes. In fact, the Center actually bemoans the fact that fewer kids are smoking cigarettes than experimenting with e-cigarettes. It appears that the Center would have been more pleased had the smoking rate not dropped so much, but had there been very low rates of e-cigarette use.

Is this about public health anymore, or is there some other ideological goal that I was not told about during my masters in public health training? It appears, in fact, that we are now pursuing the isolated ideological goal of conquering nicotine addiction rather than the effort to try to save lives and improve the public's health. We've reached that point. When we actually want to see more kids smoking than using a relatively benign form of nicotine instead, then we know we're no longer in public health, but in the realm of pursuing ideology.

The worst part of the story, however, is the fact that we are apparently OK with lying to the public in order to pursue even this ideological and misguided goal. The truth no longer matters to us. Conveying accurate information to the public no longer matters.

Ironically, if the tobacco companies were making precisely the same claims as the Indiana Prevention Resource Center (i.e., that smoking is no more dangerous than vaping), you can be sure that anti-smoking groups around the country would be vigorously attacking Big Tobacco for lying to the public and undermining the public's appreciation of the hazards of smoking. But when it's us doing the lying, apparently it's acceptable, as long as our ultimate end is a good one (and in this case, it's not even a good end!).

Tuesday, July 28, 2015

Data from 2014 UK Youth Survey Show No Nonsmoking Youths Becoming Regular E-Cigarette Users

Newly released data from the Smoking, Drinking and Drug Use among Young People in England - 2014 survey show that although 22% of youth ages 11-15 have experimented with electronic cigarettes, only 3% are now regular vapers and none of these regular vapers are never smokers. In the survey, regular vaping was defined as using an e-cigarette at least once per week.

The Rest of the Story

While one cannot extrapolate from these data to the situation in the U.S., they do demonstrate that at least in England, e-cigarettes are not particularly addictive and they are not serving as a gateway to smoking among youth. Despite the high rate of e-cigarette experimentation, only a small proportion of these youth experimenters are going on to become regular vapers. And of these regular vapers, none are kids who never smoked cigarettes. Thus, there is little, if any, evidence that e-cigarette experimentation among youth in England is causing public health harm. If anything, e-cigarettes may be deterring some youth from continued smoking.

This hypothesis is further supported by the finding that youth smoking in England dropped to its lowest level since the survey began in 1982, despite the dramatic increase in e-cigarette experimentation in recent years.

Despite the definitive statements of CDC and other anti-smoking groups and advocates about e-cigarettes being a gateway to youth smoking, there remains no evidence to support that contention and a growing body of evidence refutes it.

Monday, July 27, 2015

American Chemical Society Grossly Misrepresents Scientific Study in Order to Demonize E-Cigarettes

The American Chemical Society (ACS) became yet the next organization to work a hatchet job on electronic cigarettes. This time, it was the ACS claiming publicly that based on a new study, e-cigarettes may be as addictive as traditional ones.

Last Wednesday, the ACS issued a press release to accompany the publication of a new article in its journal "Chemical Research in Toxicology." The press release headline warned that "E-cigarettes May Be As Addictive as Traditional Ones."

Responding to this press release, media outlets throughout the world published articles touting the extreme addictive dangers of e-cigarettes. For example, The Daily Mail article headline warned that "E-cigarettes are just as addictive as the real thing." The first sentence of the article read: "E-cigarettes are just as addictive as the real thing, researchers have found." The article goes on to cite the new study published in Chemical Research in Toxicology.

The Rest of the Story

After reading the press release and these articles and headlines, I fully expected to find in the actual study a comparison of the addictiveness of e-cigarettes and cigarettes. But the study did nothing of the sort. In fact, there was absolutely no study of cigarettes at all, and there was no comparison of nicotine levels produced from e-cigarettes compared to regular cigarettes.

In fact, all the study did was to demonstrate a new method for determining the fraction of nicotine in e-liquids and aerosols that is present in the free-base, rather than the protonated form. And it then used that method on several e-liquids and reported that most of the nicotine in these liquids and their aerosols was in the free-base form. This is important because the free-base form is the only form that is readily absorbed into the body.

That's it! That's all the study did. It did not make any comparisons with regular cigarettes. And most importantly, it did not compare the blood nicotine profile over time with e-cigarettes to that with tobacco cigarettes. So there is no way from this study that one can draw any conclusions about the relative addictiveness of e-cigarettes and regular cigarettes.

The truth is that multiple studies have compared the profile of blood nicotine levels over time between vaping and smoking. The result, unequivocally, has been that nicotine delivery is much more efficient with real cigarettes. Most important, real cigarettes, but not most e-cigarettes, deliver nicotine in such a fashion as to create a huge nicotine spike, resulting in what users experience as a "nicotine hit." E-cigarettes generally do not produce such an effect. Thus, the scientific evidence clearly shows that e-cigarettes are not nearly as addictive as tobacco cigarettes.

So how can the American Chemical Society conclude that based on this new study, e-cigarettes are just as addictive as tobacco cigarettes? The answer is: they can't. In other words, they are literally just making it up! And even worse, because the claim is not true, they are disseminating a blatant lie to the public.

This is how low the tactics of e-cigarette opponents have fallen. They now just make it up. They literally make up evidence to support their pre-determined conclusion that e-cigarettes are every bit as terrible as regular cigarettes. In the process, they lie.

I have long since realized that the reason for their need to make things up and tell lies to the public is that they just don't have any solid evidence to rely upon to support their anti-e-cigarette positions. All of the actual scientific evidence at present points to the tremendous benefits of e-cigarettes with only minimal harms. That's not convenient for advocates who have determined in advance to oppose e-cigarettes. So they have to start making things up and telling lies.

Today's is just another example in a long string of similar stories. But now you know the rest of the story behind these hysterical headlines about the extreme health risks of e-cigarettes.

Wednesday, July 22, 2015

Australian Therapeutic Goods Administration Acknowledges that Chantix Causes Suicide But Allows it On Market, While Banning E-Cigarettes with No Known Adverse Effects

The Therapeutic Goods Administration (TGA) in Australia has publicly acknowledged that Chantix causes suicide, and that the family members of patients taking this drug must carefully watch their loved ones to make sure that they don't kill themselves. Nevertheless, the TGA apparently has no problem allowing Chantix to stay on the market. Moreover, the Administration has not even required that a black box warning be placed on the drug's packaging.

At the same time, the TGA has banned electronic cigarettes, another effective smoking cessation tool, despite the absence of any evidence that it causes substantial adverse side effects.

According to an article on the web site of ABC News Australia: "The FDA in the US first implemented its so-called "black box" warning on Champix packets in 2009, and recently strengthened it, after a huge class action involving 3,000 litigants was settled by pharmaceutical manufacturer Pfizer. But Australia's Therapeutic Goods Administration (TGA) does not require a "black box" warning and Champix currently does not contain consumer medical information inside the box either. "We've been very concerned about the drug because it has so many more adverse reactions that have been reported than pretty much any other drug," Dr Zuckerman said."

"But the response to Champix in Australia by health professionals and the TGA has been markedly different. "The TGA continually reviews the adverse events and we believe that Champix PMI and CMI contains the appropriate information to assist in its safe and effective use," a TGA spokeswoman said. "This includes appropriate warnings on neuropsychiatric-adverse events, such as self-harm and suicidal tendencies. People taking this medicine [and their family or carer] need to pay special attention to your mood, behaviour and thinking while you are taking Champix." Champix was first introduced to the Australian market in 2007 and by 2010, 900,000 prescriptions had been filled. In that time, the TGA had more than 200 reports of suicide-related events for Champix patients."

The Rest of the Story

This is perhaps the most absurd policy rationale I have ever heard. We have a smoking cessation product that is so dangerous that it can cause suicide, so alarming that we need to warn the families of patients taking the drug to watch their loved ones carefully to be sure that they don't kill themselves, yet we don't take it off the market. On the other hand, we have another smoking cessation product with no evidence of any significant clinical harms, yet we ban that product because of uncertainty over the possibility of potential adverse effects if people were to vape regularly for 20 or 30 years.

I am not necessarily arguing that Chantix should be taken off the market. The risks need to be weighed against the benefits. However, if it is justified for Chantix to remain on the market despite its known association with suicide, then it makes absolutely no sense to take electronic cigarettes off the market, despite the lack of any evidence that it causes significant adverse side effects.

Why does the TGA even need to wait for studies to see if e-cigarettes have serious side effects? The Administration has already admitted that Chantix has life-threatening side effects but allowed that drug to stay on the market without even a black box warning. Does this mean that the TGA will finally approve electronic cigarettes once they are shown to have a serious side effect, like possible sudden death? Apparently, unknown risks are of far greater concern to the Administration than known risks.

I find it rather comical (but really, sad) that the TGA believes that it is appropriate to allow a drug that it thinks causes suicide on the market, as long as you warn family members to look out for suicide attempts.

But the worst part of this story is the argument by Professor Renee Bittoun for why a black box warning should not be included on the Chantix labeling. According to the article: "Respiratory physiologist Renee Bittoun started one of the world's first "quit smoking" clinics in Sydney. "The risk you take by putting a big warning on [Champix] is that people will not take it and smokers die from it. From smoking," Associate Professor Bittoun said."

This is not a good justification for failing to require a black box warning. The fact that a black box warning might scare people away from taking a drug is no reason to not require such a warning if it is otherwise justified. After all, one could make the same argument about any drug, and so this argument is tantamount to saying that no black box warning should ever be placed on a drug because it would discourage many people from using the drug. So it's actually quite scary reasoning. The only reason to not require a black box warning is if the warning is not justified based on the scientific studies of the side effects of the drug.

The rest of the story is that Australia's TGA is taking a completely nonsensical approach to the regulation of smoking cessation products. Apparently, they would rather that smokers use products with known, serious risks than products that are probably quite safe, but whose risks are not definitively characterized. Unknown risks can't be tolerated, but serious, life-threatening risks are fine, as long as they are known.

Tuesday, July 21, 2015

Tobacco Control Journal Makes Fun of Vapers, Calling them Idiots

A cartoon appearing in this month's issue of Tobacco Control makes fun of vapers, calling them "idiots." The cartoon features a man vaping and a woman next to him. The man says: "With vaping, I get all the nicotine, none of the smoke and it makes me look cool." The woman responds: "You look like an idiot smoking a laser pointer."

The Rest of the Story

Why is Tobacco Control making fun of vapers and calling them idiots?

Imagine that the journal ran a similar cartoon about nicotine patch users. In it, the man says: With NRT, I get all the nicotine and none of the smoke." And the woman responds: "You look like an idiot putting a cream patch on your chest."

I think most readers could appreciate that a cartoon which makes fun of smokers who are using a nicotine patch to try to quit smoking, improve their health, and save their lives so that they are around longer to enjoy life and time with their families would be quite insensitive and inappropriate, especially coming from a journal that is supposed to be promoting health.

But there is no qualitative difference between such an NRT cartoon and the e-cigarette cartoon that is featured in the July issue of Tobacco Control. Both are making out smokers who are using various forms of nicotine to try to quit as looking like (and being) idiots.

Sadly, this is an accurate reflection of how so many tobacco control groups and advocates see vapers. While the nicotine patch is an acceptable way to quit smoking, the e-cigarette is not. Why? For one reason: it looks like smoking. And smoking is idiotic. And people who smoke are therefore idiots. Apparently, smokers who sincerely try to quit smoking using e-cigarettes are even worse idiots because they aren't even really smoking.

While that logic might sound stupid, it is precisely the thinking that characterizes the bulk of the "anti-smoking" movement today. That Tobacco Control saw fit to publish this cartoon demonstrates that they apparently see things in this way.

Now I recognize that a journal is not necessarily promoting the opinions expressed in a work that it publishes. For example, if a journal publishes an article which presents data suggesting that smoking in cars should be banned, the journal is not necessarily taking that position and promoting it. The journal is simply publishing an article that offers such a view. However, this is different because it is not a research article. The journal's purpose is not to provide cartoons. It made a deliberate choice to include this cartoon.

I also recognize that humor should be given a little more leeway than a scholarly piece. We all need to have a sense of humor in our work. However, dying from smoking is not a laughing matter. Neither is being addicted to cigarette smoking and being unable to quit. Nor is being fearful of dying prematurely because of an addiction that you cannot easily overcome. When smokers try to quit by switching to e-cigarettes, it is a very serious matter. It's about their health and their lives. I don't find it something to joke about. Nor do I think it is appropriate to call those people idiots because they are forced to go to such extremes to try to break the smoking addiction.

Should we call heroin addicts who try to overcome their addiction by switching to methadone idiots because they have to pop opiate pills everyday?

On the contrary, these are people who should be praised for taking control of their health and their lives and making a wise decision to switch from the most toxic form of nicotine to a much safer alternative form of nicotine. Vapers should be congratulated, not made fun of and called idiots. Does the journal prefer that these people continue smoking so as not to make fools of themselves?

It continues to baffle me why the tobacco control movement views vaping and vapers with such venomous disdain. If we had the same disdain for smokers who slop on patches or use nicotine inhalers or chewing gum, we would be writing ourselves out of the public health field. I'm afraid that's exactly what we're doing with our attitude about e-cigarettes and the people who are using these devices to try to improve their health and save their lives.

Monday, July 20, 2015

California State Senator is Fooling the Public About Hazards of Smoking Just Like the Tobacco Industry Used to Do Decades Ago

A California state Senator has accused the tobacco industry of fooling the public by asserting that electronic cigarettes are less harmful than tobacco cigarettes.

According to an article in the Daily Caller, state Senator Mark Leno stated:

"Decades ago, the tobacco industry tried to fool us into believing that filtered cigarettes were a healthier alternative to traditional cigarettes, and now they’re making the same claims about e-cigarettes."

The Rest of the Story

The only problem with this accusation is that it is not true. The tobacco industry is not fooling the public by suggesting that e-cigarettes are safer than tobacco cigarettes. Far from it. The tobacco industry is telling the truth. And so is the e-cigarette industry. Electronic cigarettes are far safer than tobacco cigarettes. There is simply no comparison. Smoking kills more than 400,000 Americans each year, while vaping is not known to have caused any deaths. In fact, unlike smoking, vaping appears to have no major acute risks.

The rest of the story is that it is actually Senator Leno who is trying to fool the public. He is trying to fool the public into believing that electronic cigarettes are no safer than the real ones. But that is equivalent to telling the public that smoking is no more hazardous than vaping.

Not only is Senator Leno lying to the public, but he is causing public health damage. First, he is undermining the public's appreciation of the hazards of smoking by telling us that smoking is only as hazardous as vaping. This truly minimizes the risks of smoking since electronic cigarettes do not contain any tobacco, do not involve combustion, and only expose users to a small number of chemicals of concern, most at very low levels.

Second, his statements are doing actual public health damage. By equating the health hazards of vaping with those of smoking, he is almost certainly discouraging many smokers from quitting (via e-cigarettes) and encouraging many former smokers (who quit via e-cigarettes) to return to smoking.

Before attacking the tobacco industry for lying about electronic cigarettes, Senator Leno should look in the mirror and check his facts. He would find that he is the one who is lying, trying to fool the public, falsely and irresponsibly minimizing the health hazards of smoking, and causing substantial public health damage by discouraging smoking cessation and encouraging many former smokers to return to smoking. 

Thursday, July 16, 2015

Study on Potential Toxicity of E-Cigarette Flavorings Produces Unwarranted Scare

A study published in the journal Tobacco Control this past April has produced an unwarranted scare about the potential toxicity of the flavorings in electronic cigarettes.

(See: Tierney PA, et al. Flavour chemicals in electronic cigarette fluids. Tobacco Control. Published online ahead of print on April 15, 2015. DOI: 0.1136/tobaccocontrol-2014-052175.)

The study used gas chromatography/mass spectrometry to analyze the chemical constituents in e-liquids of various flavors. It appears that 30 different e-liquid flavors were tested. Multiple flavors of two brands of disposable e-cigarettes (Blu and NJOY) were tested along with a convenience sample of e-liquids obtained from vape shops.

The results were reported as follows: "In many liquids, total flavour chemicals were found to be in the∼1–4% range (10–40 mg/mL); labelled levels of nicotine were in the range of 0.6–2.4% (6 to 24 mg/mL). A significant number of the flavour chemicals were aldehydes, a compound class recognised as 'primary irritants’ of mucosal tissue of the respiratory tract. Many of the products contained the same flavour chemicals: vanillin and/or ethyl vanillin was found in 17 of the liquids as one of the top three flavour chemicals, and/or at ≥ 0.5 mg/mL."

The study concludes as follows: "The concentrations of some flavour chemicals in e-cigarette fluids are sufficiently high for inhalation exposure by vaping to be of toxicological concern. Regulatory limits should be contemplated for levels of some of the more worrisome chemicals as well as for total flavour chemical levels. Ingredient labeling should also be required."

The reporting of the results of this study in the media has resulted in a health scare about the potential dangers of electronic cigarettes, with some policy makers calling for a complete ban on e-cigarette flavorings.

The Rest of the Story

Here are the chemicals that were found in the e-cigarettes:

Benzalkonium chloride: may cause rapid onset bronchoconstriction

Oleic acid: may cause respiratory irritation

Chlorofluorocarbons: destroys the ozone layer

Soya lecithin: may cause respiratory irritation

Sorbitan trioleate: may cause respiratory irritation

Sulfites: may cause life-threatening respiratory reactions

Methylparaben: possible link to breast cancer at high concentrations

Propylparaben: possible link to breast cancer at high concentrations

SORRY - that was a mistake. The above is NOT a list of the inactive chemical ingredients in e-liquids. It is a list of the inactive ingredients that have been detected in pharmaceutical inhalers, approved by the FDA.

Let's try again. Here are the chemicals that were found in the e-cigarettes:

Acetanisole, · Acetic Acid, · Acetoin, · Acetophenone, · 6-Acetoxydihydrotheaspirane, · 2-Acetyl-3- Ethylpyrazine, · 2-Acetyl-5-Methylfuran, · Acetylpyrazine, · 2-Acetylpyridine, · 3-Acetylpyridine, · 2-Acetylthiazole, · Aconitic Acid, · dl-Alanine, · Alfalfa Extract, · Allspice Extract, · Oleoresin, · And Oil, · Allyl Hexanoate, · Allyl Ionone, · Almond Bitter Oil, · Ambergris Tincture, · Ammonia, · Ammonium Bicarbonate, · Ammonium Hydroxide, · Ammonium Phosphate Dibasic, · Ammonium Sulfide, · Amyl Alcohol, · Amyl Butyrate, · Amyl Formate, · Amyl Octanoate, · alpha-Amylcinnamaldehyde, · Amyris Oil, · trans-Anethole, · Angelica Root Extract, Oil and Seed Oil, · Anise, · Anise Star, Extract and Oils, · Anisyl Acetate, · Anisyl Alcohol, · Anisyl Formate, · Anisyl Phenylacetate, · Apple Juice Concentrate, Extract, and Skins, · Apricot Extract and Juice Concentrate, · 1-Arginine, · Asafetida Fluid Extract And Oil, · Ascorbic Acid, · 1-Asparagine Monohydrate, · 1-Aspartic Acid, · Balsam Peru and Oil, · Basil Oil, · Bay Leaf, Oil and Sweet Oil, · Beeswax White, · Beet Juice Concentrate, · Benzaldehyde, · Benzaldehyde Glyceryl Acetal, · Benzoic Acid, Benzoin, · Benzoin Resin, · Benzophenone, · Benzyl Alcohol, · Benzyl Benzoate, · Benzyl Butyrate, · Benzyl Cinnamate, · Benzyl Propionate, · Benzyl Salicylate, · Bergamot Oil, · Bisabolene, · Black Currant Buds Absolute, · Borneol, · Bornyl Acetate, · Buchu Leaf Oil, · 1,3-Butanediol, · 2,3-Butanedione, · 1-Butanol, · 2-Butanone, · 4(2-Butenylidene)-3,5,5-Trimethyl-2-Cyclohexen-1-One, · Butter, Butter Esters, and Butter Oil, · Butyl Acetate, · Butyl Butyrate, · Butyl Butyryl Lactate, · Butyl Isovalerate, · Butyl Phenylacetate, · Butyl Undecylenate, · 3-Butylidenephthalide, · Butyric Acid, · Cadinene, · Caffeine, · Calcium Carbonate, · Camphene, · Cananga Oil, · Capsicum Oleoresin, · Caramel Color, · Caraway Oil, · Carbon Dioxide, · Cardamom Oleoresin, Extract, Seed Oil, and Powder, · Carob Bean and Extract, · beta-Carotene, · Carrot Oil, · Carvacrol, · 4-Carvomenthenol, · 1-Carvone, · beta-Caryophyllene, · beta-Caryophyllene Oxide, · Cascarilla Oil and Bark Extract, · Cassia Bark Oil, · Cassie Absolute and Oil, · Castoreum Extract, Tincture and Absolute, · Cedar Leaf Oil, · Cedarwood Oil Terpenes and Virginiana, · Cedrol, · Celery Seed Extract, Solid, Oil, And Oleoresin, · Cellulose Fiber, · Chamomile Flower Oil And Extract, · Chicory Extract, · Chocolate, · Cinnamaldehyde, · Cinnamic Acid, · Cinnamon Leaf Oil, Bark Oil, and Extract, · Cinnamyl Acetate, · Cinnamyl Alcohol, · Cinnamyl Cinnamate, · Cinnamyl Isovalerate, · Cinnamyl Propionate, · Citral, · Citric Acid, · Citronella Oil, · dl-Citronellol, · Citronellyl Butyrate, · Citronellyl Isobutyrate, · Civet Absolute, · Clary Oil, · Clover Tops, Red Solid Extract, · Cocoa, · Cocoa Shells, Extract, Distillate And Powder, · Coconut Oil, · Coffee, · Cognac White and Green Oil, · Copaiba Oil, · Coriander Extract and Oil, · Corn Oil, · Corn Silk, · Costus Root Oil, · Cubeb Oil, · Cuminaldehyde, · para-Cymene, · 1-Cysteine, · Dandelion Root Solid Extract, · Davana Oil, · 2-trans, 4-trans-Decadienal, · delta-Decalactone, · gamma-Decalactone, · Decanal, · Decanoic Acid, · 1-Decanol, · 2-Decenal, · Dehydromenthofurolactone, · Diethyl Malonate, · Diethyl Sebacate, · 2,3-Diethylpyrazine, · Dihydro Anethole, · 5,7-Dihydro-2-Methylthieno(3,4-D) Pyrimidine, · Dill Seed Oil and Extract, · meta-Dimethoxybenzene, · para-Dimethoxybenzene, · 2,6-Dimethoxyphenol, · Dimethyl Succinate, · 3,4-Dimethyl-1,2-Cyclopentanedione, · 3,5- Dimethyl-1,2-Cyclopentanedione, · 3,7-Dimethyl-1,3,6-Octatriene, · 4,5-Dimethyl-3-Hydroxy-2,5-Dihydrofuran-2-One, · 6,10-Dimethyl-5,9-Undecadien-2-One, · 3,7-Dimethyl-6-Octenoic Acid, · 2,4-Dimethylacetophenone, · alpha,para-Dimethylbenzyl Alcohol, · alpha,alpha-Dimethylphenethyl Acetate, · alpha,alpha Dimethylphenethyl Butyrate, · 2,3-Dimethylpyrazine, · 2,5-Dimethylpyrazine, · 2,6-Dimethylpyrazine, · Dimethyltetrahydrobenzofuranone, · delta-Dodecalactone, · gamma-Dodecalactone, · para-Ethoxybenzaldehyde, · Ethyl 10-Undecenoate, · Ethyl 2-Methylbutyrate, · Ethyl Acetate, · Ethyl Acetoacetate, · Ethyl Alcohol, · Ethyl Benzoate, · Ethyl Butyrate, · Ethyl Cinnamate, · Ethyl Decanoate, · Ethyl Fenchol, · Ethyl Furoate, · Ethyl Heptanoate, · Ethyl Hexanoate, · Ethyl Isovalerate, · Ethyl Lactate, · Ethyl Laurate, · Ethyl Levulinate, · Ethyl Maltol, · Ethyl Methyl Phenylglycidate, · Ethyl Myristate, · Ethyl Nonanoate, · Ethyl Octadecanoate, · Ethyl Octanoate, · Ethyl Oleate, · Ethyl Palmitate, · Ethyl Phenylacetate, · Ethyl Propionate, · Ethyl Salicylate, · Ethyl trans-2-Butenoate, · Ethyl Valerate, · Ethyl Vanillin, · 2-Ethyl (or Methyl)-(3,5 and 6)-Methoxypyrazine, · 2-Ethyl-1-Hexanol, 3-Ethyl -2 -Hydroxy-2-Cyclopenten-1-One, · 2-Ethyl-3, (5 or 6)-Dimethylpyrazine, · 5-Ethyl-3-Hydroxy-4-Methyl-2(5H)-Furanone, · 2-Ethyl-3-Methylpyrazine, · 4-Ethylbenzaldehyde, · 4-Ethylguaiacol, · para-Ethylphenol, · 3-Ethylpyridine, · Eucalyptol, · Farnesol, · D-Fenchone, · Fennel Sweet Oil, · Fenugreek, Extract, Resin, and Absolute, · Fig Juice Concentrate, · Food Starch Modified, · Furfuryl Mercaptan, · 4-(2-Furyl)-3-Buten-2-One, · Galbanum Oil, · Genet Absolute, · Gentian Root Extract, · Geraniol, · Geranium Rose Oil, · Geranyl Acetate, · Geranyl Butyrate, · Geranyl Formate, · Geranyl Isovalerate, · Geranyl Phenylacetate, · Ginger Oil and Oleoresin, · 1-Glutamic Acid, · 1-Glutamine, · Glycerol, · Glycyrrhizin Ammoniated, · Grape Juice Concentrate, · Guaiac Wood Oil, · Guaiacol, · Guar Gum, · 2,4-Heptadienal, · gamma-Heptalactone, · Heptanoic Acid, · 2-Heptanone, · 3-Hepten-2-One, · 2-Hepten-4-One, · 4-Heptenal, · trans -2-Heptenal, · Heptyl Acetate, · omega-6-Hexadecenlactone, · gamma-Hexalactone, · Hexanal, · Hexanoic Acid, · 2-Hexen-1-Ol, · 3-Hexen-1-Ol, · cis-3-Hexen-1-Yl Acetate, · 2-Hexenal, · 3-Hexenoic Acid, · trans-2-Hexenoic Acid, · cis-3-Hexenyl Formate, · Hexyl 2-Methylbutyrate, · Hexyl Acetate, · Hexyl Alcohol, · Hexyl Phenylacetate, · 1-Histidine, · Honey, · Hops Oil, · Hydrolyzed Milk Solids, · Hydrolyzed Plant Proteins, · 5-Hydroxy-2,4-Decadienoic Acid delta- Lactone, · 4-Hydroxy-2,5-Dimethyl-3(2H)-Furanone, · 2-Hydroxy-3,5,5-Trimethyl-2-Cyclohexen-1-One, · 4-Hydroxy -3-Pentenoic Acid Lactone, · 2-Hydroxy-4-Methylbenzaldehyde, · 4-Hydroxybutanoic Acid Lactone, · Hydroxycitronellal, · 6-Hydroxydihydrotheaspirane, · 4-(para-Hydroxyphenyl)-2-Butanone, · Hyssop Oil, · Immortelle Absolute and Extract, · alpha-Ionone, · beta-Ionone, · alpha-Irone, · Isoamyl Acetate, · Isoamyl Benzoate, · Isoamyl Butyrate, · Isoamyl Cinnamate, · Isoamyl Formate, Isoamyl Hexanoate, · Isoamyl Isovalerate, · Isoamyl Octanoate, · Isoamyl Phenylacetate, · Isobornyl Acetate, · Isobutyl Acetate, · Isobutyl Alcohol, · Isobutyl Cinnamate, · Isobutyl Phenylacetate, · Isobutyl Salicylate, · 2-Isobutyl-3-Methoxypyrazine, · alpha-Isobutylphenethyl Alcohol, · Isobutyraldehyde, · Isobutyric Acid, · d,l-Isoleucine, · alpha-Isomethylionone, · 2-Isopropylphenol, · Isovaleric Acid, · Jasmine Absolute, Concrete and Oil, · Kola Nut Extract, · Labdanum Absolute and Oleoresin, · Lactic Acid, · Lauric Acid, · Lauric Aldehyde, · Lavandin Oil, · Lavender Oil, · Lemon Oil and Extract, · Lemongrass Oil, · 1-Leucine, · Levulinic Acid, · Licorice Root, Fluid, Extract and Powder, · Lime Oil , · Linalool, · Linalool Oxide, · Linalyl Acetate, · Linden Flowers, · Lovage Oil And Extract, · 1-Lysine, · Mace Powder, Extract and Oil , · Magnesium Carbonate, · Malic Acid, · Malt and Malt Extract, · Maltodextrin, · Maltol, · Maltyl Isobutyrate, · Mandarin Oil, · Maple Syrup and Concentrate, · Mate Leaf, Absolute and Oil, · para-Mentha-8-Thiol-3-One, · Menthol, · Menthone, · Menthyl Acetate, · dl-Methionine, · Methoprene, · 2-Methoxy-4-Methylphenol, · 2-Methoxy-4-Vinylphenol, · para-Methoxybenzaldehyde, · 1-(para-Methoxyphenyl)-1-Penten-3-One, · 4-(para-Methoxyphenyl)-2-Butanone, · 1-(para-Methoxyphenyl)-2-Propanone, · Methoxypyrazine, · Methyl 2-Furoate, · Methyl 2-Octynoate, · Methyl 2-Pyrrolyl Ketone, · Methyl Anisate, · Methyl Anthranilate, · Methyl Benzoate, · Methyl Cinnamate, · Methyl Dihydrojasmonate, · Methyl Ester of Rosin, Partially Hydrogenated, · Methyl Isovalerate, · Methyl Linoleate (48%), · Methyl Linolenate (52%) Mixture, · Methyl Naphthyl Ketone, · Methyl Nicotinate, · Methyl Phenylacetate, · Methyl Salicylate, · Methyl Sulfide, · 3-Methyl-1-Cyclopentadecanone, · 4-Methyl-1-Phenyl-2-Pentanone, · 5-Methyl-2-Phenyl-2-Hexenal, · 5-Methyl-2-Thiophenecarboxaldehyde, · 6-Methyl-3,-5-Heptadien-2-One, · 2-Methyl-3-(para-Isopropylphenyl) Propionaldehyde, · 5-Methyl-3-Hexen-2-One, · 1-Methyl-3Methoxy-4-Isopropylbenzene, · 4-Methyl-3-Pentene-2-One, · 2-Methyl-4-Phenylbutyraldehyde, · 6-Methyl-5-Hepten-2-One, · 4-Methyl-5-Thiazoleethanol, · 4-Methyl-5-Vinylthiazole, · Methyl-alpha-Ionone, · Methyl-trans-2-Butenoic Acid, · 4-Methylacetophenone, · para-Methylanisole, · alpha-Methylbenzyl Acetate, · alpha-Methylbenzyl Alcohol, · 2-Methylbutyraldehyde, · 3-Methylbutyraldehyde, · 2-Methylbutyric Acid, · alpha-Methylcinnamaldehyde, · Methylcyclopentenolone, · 2-Methylheptanoic Acid, · 2-Methylhexanoic Acid, · 3-Methylpentanoic Acid, · 4-Methylpentanoic Acid, · 2-Methylpyrazine, · 5-Methylquinoxaline, · 2-Methyltetrahydrofuran-3-One * (Methylthio)Methylpyrazine (Mixture Of Isomers), · 3-Methylthiopropionaldehyde, · Methyl 3-Methylthiopropionate, · 2-Methylvaleric Acid, · Mimosa Absolute and Extract, · Molasses Extract and Tincture, · Mountain Maple Solid Extract, · Mullein Flowers, · Myristaldehyde, · Myristic Acid, · Myrrh Oil, · beta-Napthyl Ethyl Ether, · Nerol, · Neroli Bigarde Oil, · Nerolidol, · Nona-2-trans,6-cis-Dienal, · 2,6-Nonadien-1-Ol, · gamma-Nonalactone, · Nonanal, · Nonanoic Acid, · Nonanone, · trans-2-Nonen-1-Ol, · 2-Nonenal, · Nonyl Acetate, · Nutmeg Powder and Oil, · Oak Chips Extract and Oil, · Oak Moss Absolute, · 9,12-Octadecadienoic Acid (48%) And 9,12,15-Octadecatrienoic Acid (52%), · delta-Octalactone, · gamma-Octalactone, · Octanal, · Octanoic Acid, · 1-Octanol, · 2-Octanone, · 3-Octen-2-One, · 1-Octen-3-Ol, · 1-Octen-3-Yl Acetate, · 2-Octenal, · Octyl Isobutyrate, · Oleic Acid , · Olibanum Oil, · Opoponax Oil And Gum, · Orange Blossoms Water, Absolute, and Leaf Absolute, · Orange Oil and Extract, · Origanum Oil, · Orris Concrete Oil and Root Extract, · Palmarosa Oil, · Palmitic Acid, · Parsley Seed Oil, · Patchouli Oil, · omega-Pentadecalactone, · 2,3-Pentanedione, · 2-Pentanone, · 4-Pentenoic Acid, · 2-Pentylpyridine, · Pepper Oil, Black And White, · Peppermint Oil, · Peruvian (Bois De Rose) Oil, · Petitgrain Absolute, Mandarin Oil and Terpeneless Oil, · alpha-Phellandrene, · 2-Phenenthyl Acetate, · Phenenthyl Alcohol, · Phenethyl Butyrate, · Phenethyl Cinnamate, · Phenethyl Isobutyrate, · Phenethyl Isovalerate, · Phenethyl Phenylacetate, · Phenethyl Salicylate, · 1-Phenyl-1-Propanol, · 3-Phenyl-1-Propanol, · 2-Phenyl-2-Butenal, · 4-Phenyl-3-Buten-2-Ol, · 4-Phenyl-3-Buten-2-One, · Phenylacetaldehyde, · Phenylacetic Acid, · 1-Phenylalanine, · 3-Phenylpropionaldehyde, · 3-Phenylpropionic Acid, · 3-Phenylpropyl Acetate, · 3-Phenylpropyl Cinnamate, · 2-(3-Phenylpropyl)Tetrahydrofuran, · Phosphoric Acid, · Pimenta Leaf Oil, · Pine Needle Oil, Pine Oil, Scotch, · Pineapple Juice Concentrate, · alpha-Pinene, beta-Pinene, · D-Piperitone, · Piperonal, · Pipsissewa Leaf Extract, · Plum Juice, · Potassium Sorbate, · 1-Proline, · Propenylguaethol, · Propionic Acid, · Propyl Acetate, · Propyl para-Hydroxybenzoate, · Propylene Glycol, · 3-Propylidenephthalide, · Prune Juice and Concentrate, · Pyridine, · Pyroligneous Acid And Extract, * * Pyrrole, * Pyruvic Acid, * Raisin Juice Concentrate, * Rhodinol, * Rose Absolute and Oil, * Rosemary Oil, * Rum, * Rum Ether, * Rye Extract, * Sage, Sage Oil, and Sage Oleoresin, * Salicylaldehyde, * Sandalwood Oil, Yellow, * Sclareolide, * Skatole, * Smoke Flavor, * Snakeroot Oil, * Sodium Acetate, * Sodium Benzoate, * Sodium Bicarbonate, * Sodium Carbonate, * Sodium Chloride, * Sodium Citrate, * Sodium Hydroxide, * Solanone, * Spearmint Oil, * Styrax Extract, Gum and Oil, * Sucrose Octaacetate, * Sugar Alcohols, * Sugars, * Tagetes Oil, * Tannic Acid, * Tartaric Acid, * Tea Leaf and Absolute, * alpha-Terpineol, * Terpinolene, * Terpinyl Acetate, * 5,6,7,8-Tetrahydroquinoxaline, * 1,5,5,9-Tetramethyl-13-Oxatricyclo(8.3.0.0(4,9))Tridecane, * 2,3,4,5, and 3,4,5,6-Tetramethylethyl-Cyclohexanone, * 2,3,5,6-Tetramethylpyrazine, * Thiamine Hydrochloride, * Thiazole, * 1-Threonine, * Thyme Oil, White and Red, * Thymol, * Tobacco Extracts, * Tochopherols (mixed), * Tolu Balsam Gum and Extract, * Tolualdehydes, * para-Tolyl 3-Methylbutyrate, * para-Tolyl Acetaldehyde, * para-Tolyl Acetate, * para-Tolyl Isobutyrate, * para-Tolyl Phenylacetate, * Triacetin, * 2-Tridecanone, * 2-Tridecenal, * Triethyl Citrate, * 3,5,5-Trimethyl -1-Hexanol, * para,alpha,alpha-Trimethylbenzyl Alcohol, * 4-(2,6,6-Trimethylcyclohex-1-Enyl)But-2-En-4-One, * 2,6,6-Trimethylcyclohex-2-Ene-1,4-Dione, * 2,6,6-Trimethylcyclohexa-1,3-Dienyl Methan, * 4-(2,6,6-Trimethylcyclohexa-1,3-Dienyl)But-2-En-4-One, * 2,2,6-Trimethylcyclohexanone, * 2,3,5-Trimethylpyrazine, * 1-Tyrosine, * delta-Undercalactone, * gamma-Undecalactone, * Undecanal, * 2-Undecanone, 1 * 0-Undecenal, * Urea, * Valencene, * Valeraldehyde, * Valerian Root Extract, Oil and Powder, * Valeric Acid, * gamma-Valerolactone, * Valine, * Vanilla Extract And Oleoresin, * Vanillin, * Veratraldehyde, * Vetiver Oil, * Vinegar, * Violet Leaf Absolute, * Walnut Hull Extract, * Water, * Wheat Extract And Flour, * Wild Cherry Bark Extract, * Wine and Wine Sherry, * Xanthan Gum, * 3,4-Xylenol, * Yeast Benzene 2-Napthylamine 4-Aminobiphenyl Nickel Polonium 210 (radioactive) Nitrogen oxides N-Nitrosodimethylamine N-Nitrosodiethylamine N-Nitrosopyrrolidine 1,3-Butadiene Analine Formaldehyde Hydrazine N-Nitrodiethanolamine Cadmium Benzo[a]pyrene Benz[a]anthracene Y-Butyrolactone Particulate matter N-Nitrosonornicotine NNK Carbon monoxide Carbon dioxide Carbonyl sulfide Toluene Acrolein Acetone Pyridine 3-Methylpyridine 3-Vinylpyridine Hydrogen cyanide Ammonia Methylamine Dimethylamine Nicotine Anatabine Phenol Catechol Hydorquinone Cholesterol Quinoline Harman Zinc Benzoic acid Lactic acid Glycolic acid Succinic acit PCDDs and PCDFs (Dioxins, Dibenzofurans) Formic acid Acetic acid Methyl chloride Dimethylnitrosamine Ethylmethylnitrosamine Nitrosopyrrolidine Hydrazine Vinyl Chloride Urethane Formaldehyde Carbon Monoxide Hydrogen Cyanide Acrolein Acetadehyde Nitrogen oxides Ammonia Pyridine Nitric acid Mathylamine Hydrogen cyanide Indole 3-hydroxypyridine 3-vinylpyridine Acetone Acetonitrile Acrolein 1,3-Butadiene, mg Nitrous acid isoquioline Isoamylamine 3-Cyanopyridine Carbonyls Formaldehyde, Acetaldehyde, Acetone, Acrolein, Propionaldehyde, Crotonaldehyde, Methyl-Ethyl-Ketone, Butyraldehyde Phenolics Hydroquinone, Resorcinol, Catechol, Phenol, Cresol (m+p and o) Benzo[a]pyrene BaP (HPLC) Aromatic Amines 3- and 4-aminobiphenyl, 1- and 2- aminonapthlene, o-toluidine, o-anisidine Oxides of Nitrogen NO, NOx Hydrogen Cyanide HCN (gas and particulate phases) Ammonia NH3 by ion chromatography Volatiles Benzene, Toluene, 1,3-butadiene, Isoprene, Acrylonitrile Semi-Volatiles Pyridine, Quinoline, Styrene Trace Metals Nickel (Ni) Cadmium (Cd) Lead (Pb) Chromium (Cr) Arsenic (As) Selenium (Se) Mercury Mercury (Hg) Smoke pH Integrated Puff Profile Tobacco Specific Nitrosamines N-Nitrosonornicotine (NNN) N-Nitrosoanabasine (NAB) N-Nitrosoanatabine (NAT) 4-(N-nitrosomethylamino)-1-(3-pyridyl)-1-butanone (NNK) Volatile Nitrosamines N,N-Nitrosodimethylamine (NDMA) N-Nitrosopyrrolidine (NPYR) N,N-Nitrosodiethylamine (NDEA) N,N-Nitrosoethylmethylamine (NEMA) N,N-Nitrosodipropylamine (NDPA) N,N-Nitrosodibuthylamine (NDBA) N-Nitrosopiperidine (NPIP) Polycyclic Aromatic Hydrocarbons Naphthalene 1-Methylnaphthalene 2-methylnaphthalene Acenaphthylene Acenaphthene Fluorene Phenanthrene Anthracene Fluoranthene Pyrene Benzo(a)anthracene Chrysene Benzo(b)fluoranthene Benzo(k)fluoranthene Benzo(j)fluoranthene Benzo(g,h,l)perylene Benzo(e)pyrene Benzo(a)pyrene Perylene Indeno(1,2,3,-cd)pyrene Dibenzo(a,h)anthracene Dibenz(a,j)acridine Dibenz(a,h)acridine Dibenz(a,e)pyrene Dibenz(a,h)pyrene Dibenz(a,i)pyrene Dibenz(a,l)pyrene 7H-Dibenzo(c,g)carbazole Heterocyclic Aromatic Amines 2-Amino-3-methylimidaszo(4,5-f)quinoline (IQ) 2-Amino-3,4-dimethylimidazo(4,5-f)quinoline (MeIQ) 2-Amino-3-methyl-9H-pyrido(2,3-b)indole (MeAaC) 2-Amino-9H-pyrido(2,3-b)indole (AaC) 1-Methyl-9H-pyridol(3,4-b)indole (Harman) 9H-Pyrido(3,4-b)indole (Norharman) Nitrogen 280-320 mg (56-64%b) Oxygen 50-70 mg (11-14%b) Carbon dioxide 45-65 mg (9-13%b) Carbon monoxide 14-23 mg (2.8-4.6%b) Water 7-12 mg (1.4-2.4%b) Argon 5mg (1.0%b) Hydrogen 0.5-1.0 mg Ammonia 10-130 μg Nitrogen oxides (NOx) 100-600 μg Hydrogen cyanide 400-500 μg Hydrogen sulfide 20-90 μg Methane 1.0-2.0 mg Other volatile alkanes (20) 1.0-.16 mgc Volatile alkenes (16) 0.4-0.5mg Isoprene 0.2-0.4mg Butadiene 25-40μg Acetylene 20-35μg Benzene 12-50μg Toluene 20-60μg Styrene 10μg Other volatile aromatic hydrocarbons (29) 15-30μg Formic acid 200-600 μg Acetic acid 300-1,700 μg Propionic acid 100-300 μg Methyl formate 20-30 μg Other volatile acids (6) 5-10 μgc Formaldehyde 20-100 μg Acetaldehyde 400-1,400 μg Acrolein 60-140 μg Other volatile aldehydes (6) Acetone Other volatile ketones (3) Methanol Other volatile alcohols (7) Acetonitrile Other volatile nitriles (I0) Furan Other volatile furans (4) Pyridine Picolines (3) 3-Vinylpyridine Other volatile pyridines (25) Pyrrole Pyrrolidine N-Methylpyrrolidine Volatile pyrazines (18) Methylamine Other aliphatic amines (32) Nornicotine Anatabine Anabasine Other tobacco alkaloids (17) Bipyridyls (4) n-Hentriacontane (n-C31H64) Total nonvolatile hydrocarbons (45)b Naphthalene Other naphthalenes (23) Phenanthrenes (7) Anthracenes (5) Fluorenes (7) Pyrenes (6) Fluoranthenes (5) Carcinogenic polynuclear aromatic hydrocarbons (11)c Phenol Other phenols (45)b Catechol Other catechols (4) Other dihydroxybenzenes (10) Scopoletin Other polyphenols (8)b Cyclotenes (10)b Quinones (7) Solanesol Neophytadienes (4) 200-350 Limonene 30-60 Other terpenes (200-250)b NA Palmitic acid 100-150 Stearic acid 50-75 Oleic acid 40-110 Linoleic acid 60-150 Linolenic acid 150-250 Lactic acid 60-80 Indole 10-15 Skatole 12-16 Other indoles (13) NA Quinolines (7) 2-4 Other N-heterocyclic hydrocarbons (55) NA Benzofurans (4) 200-300 Other O-heterocyclic hydrocarbons (42) NA Stigmasterol 40-70 Sitosterol 30-40 Campesterol 20-30 Cholesterol 10-20 Aniline 0.36 Toluidines 0.23 Other aromatic amines (12) 0.25 Tobacco-specific N-nitrosamines (4)c 0.34-2.7 Glycerol PAH Benz(a)anthracene Benzo(b)fluoranthene Benzo(j)fluoranthene Benzo(k)fluoranthene Benzo(a)pyrene Chrysene Dibenz(a,h)anthracene Dibenzo(a,1)pyrene Dibenzo(a,1)pyrene Indeno(1,2,3-c,d)pyrene 5-Methylchrysene Aza-arenes Quinoline Dibenz(a,h)acridine Dibenz(aj)acridine 7H-Dibenzo(c,g)carbazole N-Nitrosamines N-Nitrosodimethylamine N-Nitrosoethyl methylamine N-Nitrosodiethylamine N-Nitrosopyrrolidine N-Nitrosodiethanolamine N’-Nitrosonomicotine 4-(Methylnitrosamino)-1- (3-pyridyl)-1-butanone N’-Nitrosoanabasine N-Nitrosomorpholine 2-Toluidine 2-Naphthylamine 4-Aminobiphenyl Aldehydes Formaldehyde Acetaldehyde Crotonaldehyde Miscellaneous organic compounds Benzene Acrylonitrile 1,1-Dimethylhydrazine 2-Nitropropane Ethylcarbamate Vinylchloride Inorganic compounds Hydrazine Arsenic Nickel Chromium Cadmium Lead Polonium-210 Asbestos Plutonium

SORRY - that was also a mistake. The above is NOT a list of the inactive chemical ingredients in e-liquids. It is a list of the inactive ingredients that have been detected in the smoke from cigarettes, also approved for sale, marketing, and inhalation by the FDA.

Here is the actual list of chemicals in the flavoring components found in e-liquids, which have not yet been approved for sale by the FDA:

Vanillin, maltol, ethyl maltol, ethyl vanillin, benzaldehyde, p-tolualdehyde, benzyl alcohol, limonene, ethyl butyrate, ethyl acetate, gamma-undecalactone, menthol, eugenol, 2-methylbutyl acetate, cinnemaldehyde, ethyl hexanoate, menthone, piperanal,  carvone, methyl anthranilate, ethyl isovalerate, hexyl acetate, hexenol.

My point is four-fold:

1. The chemicals in electronic cigarettes - the "inactive" ingredients if you will - are not dissimilar to inactive ingredients in many pharmaceutical inhalers that are approved by the FDA. The chemicals in those inhalers are known to cause respiratory irritation. Yes, it is true that some of the chemicals in the e-liquids, especially the aldehydes, could cause some mild respiratory irritation. However, there is no reason to believe at present that the degree of respiratory irritation is substantially different than what occurs with the inhalation of approved FDA drugs.

2. The chemicals detected in e-cigarette flavorings present an extremely low level of risk when compared to the chemicals in tobacco smoke. The difference is essentially between a behavior that results in destruction of the lungs and a behavior that may cause, at the worst, mild respiratory irritation. Let's keep a sense of perspective here. Most of the individuals who are regular users of e-cigarettes are former smokers who have quit or current smokers. In either case, switching to vaping is the most important thing they can do to protect their health, assuming they are unable to quit nicotine use completely, which is probably the case for most vapers (that is why they tried vaping in the first place; had they been able to quit cold turkey, they would have).

3. One cannot necessarily draw conclusions about human health risks based solely on looking at a list of ingredients. The dose of exposure is critical. We do not know enough at this point for anyone to conclude that the flavorings in electronic cigarettes pose a significant risk of substantial adverse health effects. Moreover, there has been enough short-term use of these products for us to feel somewhat confident that we are not observing acute toxicity due to these products. Any potential risks would likely be very long-term. And we don't even know yet whether it is possible to sustain vaping for the 20 or 30 years that would be necessary before any respiratory irritant effect would translate into clinical lung disease, or if anyone would want to do that.

4. Remember that e-cigarettes are recreational products, not pharmaceutical products. The critical concern is not their absolute level of safety, but their relative level of safety compared to real cigarettes. The analysis presented in this paper is actually reassuring, because it provides irrefutable evidence that e-cigarettes are much, much safer than real ones.

Before closing, let me make three important points.

First, although I don't think a health scare over the flavorings in e-cigarettes is warranted, I do support reasonable regulations and safety standards to minimize any health risks from e-cigarettes. And I do support full disclosure of ingredients. So I actually agree with the article's ultimate recommendation that the ingredients of e-cigarettes should be listed for the consumer and that the FDA exercise some reasonable degree of regulation over the flavorings. But clearly, a ban on e-cigarette flavorings is completely unwarranted.

Second, there may be a few select flavorings that absolutely should not be used in e-cigarettes. Dr. Farasalinos has made a compelling case that diacetyl should not be used as a flavoring because of its known potential for severe respiratory effects. It would not be unreasonable for the FDA to promulgate a list of a few select flavorings that should not be used in these products, nor would it be unreasonable to restrict the total percentage of flavorings to some reasonable proportion of the overall e-liquid.

Third, it is worth noting that two of the authors of this paper are co-authors on the paper which concluded that vaping is more hazardous than smoking based on high levels of formaldehyde, levels that resulting from the severe overheating of the e-liquid producing dry puff conditions under which no vaper would continue vaping. The apparent bias of these researchers against e-cigarettes should be considered in interpreting the results of the study.

Wednesday, July 15, 2015

New Study Finds that E-Cigarettes Have No Adverse Effect on Respiratory Epithelial Cells, While Tobacco Smoke Kills the Cells

A new study conducted by British American Tobacco and published in the journal Toxicology in Vitro reports that e-cigarette aerosol from two conventional products had no adverse effect on human respiratory epithelial cells (in cell culture), while tobacco smoke caused almost complete cell death.

The methods and results are summarized as follows: "EpiAirway™ tissues [in vitro respiratory epithelial cells in culture] were exposed to cigarette smoke and aerosol generated from two commercial e-cigarettes for up to 6 h. Cigarette smoke reduced cell viability in a time dependent manner to 12% at 6 h. E-cigarette aerosol showed no such decrease in cell viability and displayed similar results to that of the untreated air controls. Applicability of the EpiAirway™ model and exposure system was demonstrated, showing little cytotoxicity from e-cigarette aerosol and different aerosol formulations when compared directly with reference cigarette smoke, over the same exposure time."

According to a British American Tobacco press release: "Until now, there have been no aerosol studies of potential adverse effects of e-cigarette vapour on in vitro models that so closely mimic the structure, function and exposure of normal human airway tissue. The researchers combined a commercially available 3D model of respiratory epithelial tissue and the popular VITROCELL smoking robot, an aerosol exposure system, to assess the irritant potential of e-cigarette vapour from two commercially available e-cigarettes on human airway tissue. The results show that, despite hours of aggressive and continuous exposure, the impact of the e-cigarette vapour on the airway tissue is similar to that of air."

The overall conclusion of the study was as follows: "Further studies will need to be conducted to compare between different commercially available products, formats,and formulations, but our data suggest that e-cigarette aerosols have significantly less impact than cigarette smoke over the duration of a 6 h exposure in vitro using organotypic tissue constructs."

The two products tested were NJOY Bold and NJOY Menthol.

The Rest of the Story

While one cannot necessarily extrapolate from this study to all e-cigarette products, at least we now know that one major brand of electronic cigarettes appears to have relatively benign effects on the cells lining the respiratory tract, in contrast to cigarette smoke which exhibits very high levels of cytotoxicity. This finding is consistent with earlier studies showing that the aerosol produced by NJOY e-cigarettes did not contain measurable quantities of most of the chemicals of concern that have been detected in the aerosol produced by some e-cigarette brands.

A major contribution of this research is that it sets out a procedure that could be used to test the cytotoxicity of various brands of electronic cigarettes, providing some assessment of the potential for respiratory irritation or inflammation that could be associated with these products. It could also help the FDA identify manufacturing procedures and/or quality control measures that prevent the formation of the unwanted chemicals in e-cigarette vapor, which could aid the agency in crafting quality standards to ensure that e-cigarettes on the market are as safe as they can be.

Despite the limitations of the research, it adds additional evidence to support the contention that vaping is a lot safer than smoking. Moreover, it suggests that it is possible to produce an e-cigarette that has little cytotoxicity to respiratory epithelial cells.

I am by no means an expert on e-cigarette design, but I can't help but think that the careful voltage and temperature regulation that the tobacco companies and the large independent e-cigarette companies have built into their products have a great deal to do with the fact that the aerosol produced by these products appears to present few concerns about the chemicals present or about the aerosol's cytotoxicity. Overheating is likely a major reason why some products have been found to produce an aerosol that does contain a number of toxins, such as various aldehydes.

This research adds to the evidence suggesting that with proper regulation, the FDA could maximize the potential benefits of e-cigarettes while minimizing their potential harms. If embraced by the agency, e-cigarettes have the potential to transform the nicotine market and produce a dramatic shift away from combustible tobacco products (i.e., cigarettes) and toward non-combusted, non-tobacco-containing e-cigarettes. Such a phenomenon would result in the greatest public health miracle of our lifetimes.

Unfortunately, I do not believe that the anti-tobacco groups or major health agencies, including the CDC or the FDA, are aiming to try to transform the nicotine market and achieve this huge public health victory. Instead, they are taking a zero-risk, zero-addiction approach that is ideal in a fantasy world, but destructive to the public's health in the real world.

Tuesday, July 14, 2015

Minneapolis City Council Supports Continued Addiction of Kids to Flavored Tobacco Products

In a move of striking hypocrisy and cowardice, the Minneapolis City Council has decided to continue supporting the addiction of its kids to flavored tobacco products. What makes the move hypocritical, however, is that the Council has claimed to ban the sale of flavored tobacco products in the city, with the only exception being specialty tobacco shops limited to adults, citing the urgent need to protect the health of future generations by preventing youth from becoming addicted to nicotine.

According to an article in the Southwest Journal: "The City Council has unanimously voted to approve new restrictions on the sale of flavored tobacco products — a policy change designed to prevent young people from smoking. The sale of flavored tobacco products will be limited to specialty tobacco shops, which are required to restrict people under age 18 from entering. ... “We heard loud and clear from Minneapolis youth that flavored tobacco products are what most kids use when they start smoking,” said Gordon, chair of the Health, Environment and Community Engagement Committee. “We believe that limiting access to these products will help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations.”"

The Rest of the Story

What policy makers in Minneapolis are not telling the public is that the new law exempts the one flavor that is most popular among kids in their jurisdiction and which most contributes to youth addiction to tobacco products: menthol.

In fact, about 50% of youth smokers in middle school prefer menthol flavored cigarettes. And about 81% of African American middle school smokers prefer menthol flavored cigarettes. There are 1.3 million youth menthol smokers in the U.S., making menthol the single and overwhelmingly most popular flavored tobacco product among our nation's youth, including those in Minneapolis.

So while politicians in Minneapolis can boast that youth in that city will not have access to chocolate, vanilla, honey, and cocoa tobacco products, the ordinance does nothing to actually address the most popular flavored tobacco product that Minneapolis youth are actually using: menthol cigarettes. 

One might ask why it is that if policy makers in Minneapolis aimed to "help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations," they chose to exempt the primary flavored tobacco products that youth are actually using.

The answer is quite simple: the true aim was not to "help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations," but to score a political victory without having to actually put a dent in tobacco sales and thus alienate tobacco companies or engender any serious political opposition.

The rest of the story is that the primary aim of these policy makers appears to be protecting the sales of the most popular and important flavored tobacco products among youth tobacco users, so as not to threaten the profits of cigarette companies.

It is difficult to find a sincere desire to "help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations" when one reads the fine print of the ordinance and considers the rest of the story.  

Rather than close the loophole which exempted menthol cigarettes from the FDA's flavored cigarette "ban," the Minneapolis City Council chose to look the other way, while distracting attention from its decision to ignore the problem by praising itself for eliminating youth access to chocolate cigars and cigarillos. 

The rest of the story is that the Council's claim to want to "help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations" is complete crap. If it were truly sincere, the Council would not have exempted menthol cigarettes, which is overwhelmingly the most popular flavored tobacco product among youth in Minneapolis and which contributes most to harming the health of future generations.

Monday, July 13, 2015

Congressional Democrats Protect Cigarette Company Profits, then Attack Republicans for Aiding Tobacco Industry

In an ironic and hypocritical action, Congressional Democrats last week attempted to aid cigarette companies by protecting them from competition and then proceeded to attack Republicans for siding with the tobacco industry.

Congressional Republicans, concerned that the soon to be released FDA deeming regulations for electronic cigarettes would devastate the electronic cigarette industry and force hundreds of e-cigarette products off the market, putting many e-cigarette shops and small companies out of business, inserted language in an appropriations bill that would prevent the FDA from requiring new product applications for e-cigarettes already on the market as of the effective date of the deeming regulations. In the proposed regulations, only products already on the market in February 2007 would be relieved from the need to file a new product application. According to an article in the Washington Post, Congressional Democrats tried to strip that language from the bill, at the same time attacking Republicans for siding with the tobacco industry on this issue.

According to the article: "This week, Democrats accused Republicans of “tucking a special interest giveaway to the tobacco industry” in an agriculture appropriations bill. The White House scolded them that spending bills should be “free of ideological provisions.” Public health groups warned they’re putting children at risk. But Republicans stood fast Wednesday to vote down a Democratic amendment to strip out language exempting tobacco products, like e-cigarettes, which are already on the market, from a retroactive review by the federal government."

The Rest of the Story

Things are not always as they appear, and that's why there is a need to tell the rest of the story. In this case, things are actually the opposite of how the Democrats are trying to make them look.

The deeming regulations, if unchanged from the FDA's initial proposal, would not protect the public's health in any way. The major effect of the regulations would be to protect cigarettes from competition from electronic cigarettes which are much, much safer. By requiring expensive and resource-intensive new product applications for every electronic cigarette product on the market, the FDA's proposed regulations would put virtually every small e-cigarette and vaping company or store out of business, leaving the entire vapor product market to the tobacco companies and a small number of independent electronic cigarette companies. A vape shop that carries 100 flavors, for example, would have to submit 100 separate applications, and each one would have to demonstrate that the particular flavored product described in the application is beneficial to the public's health, considering not only the impact on product users, but also the potential for youth and adult nonsmokers to start using the product. The FDA itself acknowledged that each application would cost about $300,000 in human resources and laboratory and clinical research, a sum that would put virtually every vape shop out of business even if it only had to submit only a single application.

By removing most flavored electronic cigarette products from the market, the regulations would do a huge favor to cigarette companies by protecting cigarettes from competition from the much safer electronic ones. While some brands of electronic cigarettes would remain on the market, there would be a loss of many flavored products that thousands of vapers are already using, forcing many of them - realistically - to return to cigarette smoking. Innovation in the industry would also be stifled. In short, market growth would be halted and the prediction that e-cigarette consumption will surpass cigarette consumption within a decade would be brought to a screeching halt.

This means that the major impact of the regulations would be to greatly increase cigarette consumption, leading to a higher incidence of disease, disability, and death. Such an action would protect cigarette sales at the expense of the public's health.

Congressional Republicans tried to undo this favor to cigarette companies by removing the requirement for all e-cigarette products to have to submit these expensive new product applications. Ironically, Congressional Democrats, by trying to strip out this provision, are acting to protect cigarette companies at the expense of the public's health.

Yet the Democrats had the gall to attack the Republicans for aiding the tobacco industry.

It is not even clear that the tobacco companies support the rider. To the best of my knowledge, they have not taken any definitive position on the issue, and it would clearly be in their best interests to let the rider pass since it would make it much more difficult for a multitude of third-generation vapor products to compete with them for the vaping market.

Contrary to the claims of those who oppose the appropriations rider, it would not affect the FDA's ability to protect children from the potential harms of electronic cigarettes, nor would it exempt any product from FDA regulatory control. The agency could still ban the sale of e-cigarettes to minors, regulate e-cigarette marketing directed at minors, and apply an unlimited set of safety standards to all electronic cigarettes (including a ban on all flavorings if the agency wanted to do that).

In fact, the rider would speed up the protection of the public's health by saving the agency from having to spend the next five or six years tied up with the tens of thousands of new product applications that could be submitted. Instead, the agency could actually step up to protect the public's health immediately by simply promulgating a set of safety and manufacturing standards for electronic cigarette devices and e-liquids.

While I don't generally find myself siding with Congressional Republicans, it is important to analyze every individual issue thoroughly from a public health perspective and not jump to conclusions solely on a political partisan basis. In this case, it is the Republicans who are acting to protect the public's health by allowing a much safer product to seriously compete with the most toxic consumer product on the market (real cigarettes), a market dynamic that could potentially cut cigarette sales in half and save millions of lives. Ironically, it is the Congressional Democrats whose actions would protect the cigarette companies and threaten the health and lives of millions of Americans.

Friday, July 10, 2015

Another Youth E-Cigarette Survey Fails to Ask the Right Questions and Compromises Study Conclusions

An article just published in the journal Addictive Behaviors presented data from the 2014 Texas Youth Tobacco Survey. It reported that 14% of middle and high school students in Texas used electronic cigarettes in the past 30 days. The prevalence of past 30-day e-cigarette use among nonsmokers who had never used any type of tobacco product was 7.3%.

(See: Cooper M, Case KR, Loukas A. E-cigarette use among Texas youth: Results from the 2014 Texas Youth Tobacco Survey. Addictive Behaviors 2015; 50:173-177.)

Despite putting out alarming conclusions about the high rate of electronic cigarette use among youth and bemoaning the fact that the prevalence of past 30-day e-cigarette use (14.0%) was higher than that for smoking (11.7%), the paper fails to mention two very important facts: (1) that electronic cigarettes are much safer than regular cigarettes; and (2) that electronic cigarettes do not contain any tobacco. In fact, the study classifies e-cigarettes as tobacco products. Moreover, in the survey instrument itself, e-cigarettes are referred to as tobacco products, thus suggesting to youth that these products contain tobacco and are therefore probably just as hazardous as real cigarettes.

The Rest of the Story

This is yet another example of how current tobacco control research is failing to ask the proper questions regarding e-cigarette use. Instead of merely asking about past 30-day e-cigarette use, these types of surveys should ascertain the number of days in the past 30 that the subject used e-cigarettes. It is possible that many of the respondents were only experimenting with e-cigarettes and that they only used these products once or twice in the past month. Some may have just tried an e-cigarette once and not used it again. Moreover, previous data suggest that although e-cigarette experimentation among nonsmokers is significant, very few of these nonsmokers are becoming regular vapers. They tend to try or use e-cigarettes in social situations but not to progress beyond that. Without asking the key question, the Texas Youth Tobacco Survey is unable to provide any sense of whether e-cigarette use among nonsmoking youth is really a problem or not.

Furthermore, by omitting from the paper the facts that e-cigarettes are much safer than real cigarettes and that they contain no tobacco and involve no combustion, the article suggests that e-cigarette experimentation among smokers is a much larger problem than it actually is.

Given that most anti-tobacco organizations are obsessed with making sure that e-cigarettes are treated no differently than cigarettes, it is surprising that they are consistently treating these products differently in terms of the questions asked in surveys. These surveys only inquire about past 30-day use of e-cigarettes, but they ask about the actual frequency of use within the past 30 days for real cigarettes.

Why the discrepancy? I believe it is because they don't want to compare daily and weekly use of e-cigarettes to daily and weekly use of e-cigarettes. They know this will destroy the story they want to tell, and it will reveal that e-cigarettes are much less addictive than the real ones. This truth is simply not a part of the story line.

Thursday, July 09, 2015

Wall Street Journal Article Predicts that FDA Deeming Regulations Could Decimate the E-Cigarette Industry

According to an article by Tripp Mickle which appeared in Tuesday's Wall Street Journal, the FDA deeming regulations, which are expected to be released later this summer, could decimate the e-cigarette industry by forcing thousands of small companies and shops out of business.

According to the article: "Within the next two months, the Food and Drug Administration is expected to complete rules that would require federal approval for nearly all flavored liquid nicotine juices and e-cig devices sold in vape shops ... The approval process could cost anywhere from $2 million to $10 million to collect data and put forward an application for each item, according to the regulatory consulting company SciLucent LLC. ... After the FDA finalizes its rule, the association [Smoke-Free Alternatives Trade Association] estimates that 99% of the industry will go out of business."

The Rest of the Story

While I think the estimated cost of application development may be exaggerated, even if the cost is closer to $400,000, that is enough to put most small e-cigarette vendors out of business. If promulgated as initially proposed last year, the regulations would require every e-cigarette product on the market (including devices and liquids) to file a new product application. An application would be required for every flavor. Thus, a vape shop might have to file hundreds of applications if it carries hundreds of flavors. Even if the cost is not prohibitive, the resource requirement will be.

These applications are not just a matter of filling out a bunch of forms and providing information. Instead, the company must demonstrate that the product in question will benefit the public's health, while taking into account not only benefits to the user, but also the possibility that nonsmokers (including youth) will start using the product. The applications need to demonstrate that the benefits of the product outweigh the risks.

Clearly, to meet the statutory requirements for new product approval, the applications will need to provide data showing that the product is effective in helping smokers quit or greatly cut down on their tobacco consumption, that the product is much safer than tobacco cigarettes, and that any costs associated with the uptake of vaping the product among youth and nonsmoking adults will not outweigh the benefits.

This is not straightforward research. It would require some rigorous studies, including clinical trials, for example, just to answer the question of how effective the product is in helping smokers quit. It seems that some sort of survey, perhaps even a longitudinal study, would be required to estimate the potential costs related to uptake of the product among youth. And it is unlikely that the FDA will accept simple chemical analysis studies to demonstrate the relative safety of e-cigarettes over real cigarettes, because the agency has stated that based on such studies that have already been conducted, it is not convinced that smoking is any more hazardous than vaping.

Moreover, separate safety studies would be required for every flavor, since the flavorings could potentially have health effects.

As I have argued before, this is not an appropriate way to regulate e-cigarettes, and I hope that the FDA regulations have not gone in this direction. Instead of creating this huge bureaucracy that will decimate the industry while doing nothing to protect the public's health, the FDA should instead simply promulgate a set of safety standards for e-cigarettes that all products must meet. Then, the companies would have to simply submit information to verify that they are in compliance with these standards. It would be a much simpler, less expensive, and reasonable process that would actually serve to protect the public's health by minimizing the costs of the product while maximizing its benefits.

There is at least some hope for a resolution of this problem even if the FDA promulgates a rule that relies on the new product application approach. Congress is considering legislation that would automatically remove any requirement for a new product application for all products already on the market at the time of the rule's effective date.

Unfortunately, this is not enough because new products introduced after the effective date of the regulations would have to submit new product applications. This would completely stifle the market, discouraging innovation that would otherwise result in safer and more effective products. It would significantly impede progress in protecting and promoting the public's health.

Congress may need to force the FDA to scrap the pre-approval requirements entirely, requiring the agency to simply promulgate a set of uniform safety standards.

Hopefully, there will not be a need for this legislation. However, based on the approach that the FDA has initially proposed, I am not hopeful that the agency is going to take the path that I recommend. It seems that the FDA is headed towards treating e-cigarettes similarly to real cigarettes. Instead, I think that the agency needs to carve out a separate and distinct regulatory framework for electronic cigarettes.