Wednesday, August 24, 2016

Anti-Tobacco Researcher: Cardiovascular Effects of E-Cigarettes are Nearly as Big as Smoking

Dr. Stan Glantz has posted a commentary on his blog in which he asserts that the results of a paper published earlier this summer in the Journal of the American College of Cardiology demonstrate that "the [cardiovascular] effects of e-cigarette use are nearly as big as smoking."

Dr. Glantz nicely summarizes the major study results: "One of the many ways that smoking damages the cardiovascular system is by stiffening major blood vessels. How stiff the aorta (the big vessel leading directly out of the heart) is can be measured by how fast the pressure wave moves down the aorta, the pulse wave moving faster when the aorta is stiffer. Following use of an e-cigarette for just 5 minutes, the pulse wave velocity increased by about 40% as much as smoking a conventional cigarettes and about 80% after 30 minutes of use."

The Rest of the Story

I agree that the study reveals that vaping has acute adverse effects on the cardiovascular system. However, I would not describe the effects of vaping as being "nearly as big as smoking." After all, smoking causes heart disease and stroke. All this study demonstrates is that vaping causes acute arterial stiffness. The study does not demonstrate whether over time, this acute effect will actually translate into vascular disease.

The results of the study are not at all surprising, since we already knew that nicotine itself causes arterial stiffness. Thus, it would have been shocking if vaping was not found to increase arterial stiffness.

What Dr. Glantz failed to note was that the adverse effect of vaping on arterial stiffness disappeared within 30 minutes after discontinuation of vaping. In contrast, the adverse effect of smoking was sustained at the 60 minute mark. The effect is reversible, and therefore it cannot be assumed that vaping will cause sustained injury that over time will lead to cardiovascular disease. It would take decades of vaping before it is even plausible that vascular disease could occur. It is quite premature to conclude that the effects of vaping are "as bad as smoking."

There are some other important things that Dr. Glantz failed to note and which anti-vaping groups will not tell you. For one, drinking coffee also causes arterial stiffness. But coffee consumption is not known to be associated with the development of cardiovascular disease and no one would state that the cardiovascular effects of drinking coffee are "as bad as smoking," even though caffeine, like nicotine, causes changes in arterial compliance acutely that are similar to the acute arterial compliance changes seen with smoking.

Sadly for my students, taking an exam has also been shown to increase aortic stiffness, just like smoking. However no one would argue that the cardiovascular effects of taking an exam are as bad as smoking. Hopefully none of my students has read Dr. Glantz's post because I can just see them trying to get out of my next exam by claiming that it will cause aortic stiffness and their doctor has advised them against any exposures that have adverse cardiovascular effects.

Watching a suspense movie also increases aortic stiffness, but no one would argue that watching a movie has cardiovascular effects that are "as bad as smoking," and as far as I know, no one has claimed that watching scary movies is a risk factor for cardiovascular disease. I didn't see too many people keeling over with heart attacks when watching Anthropoid.

High intensity resistance training also increases aortic stiffness, but I don't see a sign in the gym warning people that this type of exercising has cardiovascular effects that are "as bad as smoking."

Listening to classical or rock music actually decreases aortic stiffness, although I find that listening to Justin Bieber increases my annoyance level to extremes and I'm sure my aorta is as stiff as a lead pipe under those conditions. But I'm aware of no evidence that Beliebers have increased rates of cardiovascular disease.

Tilting your head up also increases vascular resistance.

Watching World Cup soccer also increases vascular resistance but we don't tell soccer fans that they are engaging in a habit that has health effects that are as bad as smoking.

I am not trying to downplay the finding that vaping results in acute, adverse changes in vascular function that - if repeated and sustained over decades - could plausibly increase cardiovascular disease risk. However, it is premature to draw such a conclusion and disingenuous to tell the public that the cardiovascular effects of vaping as as bad as those of smoking.

Tuesday, August 23, 2016

Campaign for Tobacco-Free Kids is Apparently Indoctrinating Youth to Lie About E-Cigarettes and Downplay the Health Hazards of Smoking

According to an article in the Arizona Daily Star, a youth tobacco control advocate is going around telling other youth that vaping can kill you. He is quoted as stating:

“Many think it’s just water vapor when really there’s nicotine, and nicotine is known to be an addictive chemical — it’s a natural pesticide and if your body takes in enough of it, it can kill you.”

The Rest of the Story

The story of a random youth from Arizona spreading false information about the risks of vaping would not ordinarily make headlines at the Rest of the Story. But when I first started reading this article, something struck me as odd. It seemed unbelievable that an intelligent 16-year-old high school student would, on his own, come to the conclusion that vaping can be fatal because nicotine is a "pesticide" and inhaling too much nicotine could cause death. It seemed especially odd when I reasoned that this youth is not exactly seeing his peers drop dead left and right from too much vaping. Also, the line about e-cigarettes delivering more than just water vapor sounded a bit too familiar. Without reading any further in the article, I came to the immediate conclusion that this must be a youth who was indoctrinated by an anti-smoking group.

Sure enough, when I continued reading the article, the rest of the story became clear. Indeed, this youth was literally indoctrinated by the Campaign for Tobacco-Free Kids after attending a youth advocacy symposium:

"Duarte, a member of the Cochise County Youth Health Coalition, recently returned from a trip to Washington, D.C., where he was advocating for the need for action to protect kids from newer tobacco products like electronic cigarettes and flavored cigars, which also have become popular. He was one of 21 youths from across the country participating in the Campaign for Tobacco-Free Kids’ Youth Advocacy Symposium, where he met with Arizona Rep. Martha McSally and the staffs of Sens. Jeff Flake and John McCain."

Now it all makes sense. It appears that in fact this youth did not come to this conclusion himself but was taught this false information during his indoctrination by the Campaign for Tobacco-Free Kids. Now he is spouting their propaganda word-for-word.

It is sad to observe that the Campaign is using youth to spread its propaganda designed to demonize electronic cigarettes and obscure the public's appreciation of the severe hazards of smoking by equating its risks only with those of using a product which is "not just water vapor."

While I completely support youth advocacy, it is essential that we be honest with youth and tell them the complete story, not just partial truths, or in the case of the Campaign for Tobacco-Free Kids - complete lies.

Saturday, August 20, 2016

New Study Purports to Show that E-Cigs are a Gateway to Smoking, But Provides No Evidence to Support that Conclusion

A new study published yesterday in the journal Tobacco Control purports to show that e-cigarettes are a gateway to smoking. The study followed 1,136 nonsmoking youth in grades 9 to 11 in Hawaii for one year to determine which youth initiated smoking during this follow-up period. Baseline surveys were conducted in 2013, and follow-up surveys were conducted in 2014. Rates of smoking initiation were compared between youths who had used e-cigarettes at baseline and those who had not used e-cigarettes. The study found that youths who had used e-cigarettes were significantly more likely to initiate smoking and that this association was stronger for youth who had a lower propensity to start smoking. Based on that finding, it concluded that e-cigarettes are a gateway to smoking.

Propensity to smoking was assessed by measuring rebelliousness, parental support, and intentions to smoke.

The study concludes as follows: "This study provides evidence that ecigarettes are recruiting lower risk adolescents to smoking, which has public health implications."

The Rest of the Story

The rest of the story is that this study does not actually provide evidence that e-cigarettes are recruiting youths to smoking. What it shows is that experimentation with e-cigarettes is a much more sensitive marker of propensity to smoking than simply assessing rebelliousness or parental support or intentions to smoke.

The major problem with the study is that it does not examine whether or not youth who experiment with e-cigarettes become addicted to vaping and then progress to smoking, which would be indicative of a gateway effect. Instead, it compares youth who have simply tried e-cigarettes with youth who never even had a puff of an e-cigarette. The study does not document that any of the youth who experimented with e-cigarettes actually became regular vapers or that they were addicted to vaping before progressing to smoking.

In fact, the paper hides a critical piece of information: although 29% of the high school students in the sample had experimented with e-cigarettes, only 2% were using them more than once a week. Therefore, at least 98% of the e-cigarette experimenters were clearly not addicted to vaping and could not be considered regular vapers.

The key problem is that the study did not determine the trajectory of e-cigarette use prior to the initiation of smoking. It is entirely possible that many of the youth who had experimented with e-cigarettes actually failed to take up vaping and that because of this failure, they started smoking. Thus, the study results are entirely consistent with the conclusion that vaping is protective against smoking initiation.

There is an alternative explanation for why youth with a lower propensity to smoke who experimented with e-cigarettes were more likely to start smoking. Namely, what this shows is that e-cigarette experimentation is a much more sensitive marker of propensity to smoke than the measure used in the study, which relied on measures of rebelliousness, parental support, and future intentions to smoke.

In fact, if you look carefully at Figure 1, you'll see that among youth who used e-cigarettes at least 5 times at baseline, propensity to smoke failed to predict smoking initiation risk. Having experimented with e-cigarettes was a much better marker of propensity to smoke than the propensity measure actually used in the study.

Let me provide an analogy to help explain this. Suppose that you were interested in studying whether using marijuana is a gateway to smoking. You do a study showing that nonsmoking youth who experiment with marijuana a few times are more likely to have initiated smoking one year later. Does this provide evidence that marijuana is a gateway to smoking?

I would argue that it doesn't. There is another plausible explanation for the study results, which is that marijuana experimentation does not cause youth to smoke, but merely is a marker for a risk-taking personality trait that predisposes to smoking.

And if we were to find that the relationship between marijuana experimentation and smoking initiation were stronger among youth who had a lower propensity to smoke, would that demonstrate that the observed relationship is because marijuana use causes kids to smoke, rather than that it is a marker for an increased baseline propensity to smoke?  No, it would not. It could be that experimentation is just a much more sensitive marker of propensity to smoke because it shows whether or not a youth has actually taken up a drug-related risk-taking behavior.

If a youth has taken up a drug-related risk-taking behavior, how could it possibly be that this youth is not more likely to also take up another drug-related risk-taking behavior?

In other words, it would be absolutely shocking if we found that youth who try e-cigarettes are not more likely to initiate smoking. I would have predicted the results found in this new study before the study was even conducted, and I would have bet my professional reputation on the fact that the study would indeed find an increased risk of smoking among youth who had experimented with e-cigarettes and that this risk would be greater among youth with a lower propensity to start smoking as measured by less definitive indicators such as parental control and general level of rebelliousness, or even stated intention to smoke.

To be clear, the rest of the story is that this new study provides no evidence that e-cigarettes are a gateway to smoking. Instead, it confirms that actual drug-related risk-taking behavior is a much better predictor of other drug-related risk-taking behavior than simply asking a kid if he thinks he will try another drug in the future or asking a kid how rebellious he is or how much his parents support him.

What would it take to actually provide evidence that marijuana use is a gateway to smoking?

Two things.

First, one would have to examine the trajectory of marijuana use. If youth who experiment with a few joints then go on to become regular marijuana users, and then over time progress to "harder" drugs like cigarettes, that would provide some evidence of a gateway effect of marijuana. But the present study presents no evidence that e-cigarette experimenters go on to become regular vapers, and then over time progress to cigarettes.

Second, one would have to provide at least some evidence of a mechanism by which the use of marijuana creates changes that then causally lead to smoking.

In the case of marijuana, there is some evidence for such an effect. As explained by the National Institute on Drug Abuse: "Early exposure to cannabinoids in adolescent rodents decreases the reactivity of brain dopamine reward centers later in adulthood.46 To the extent that these findings generalize to humans, this could help explain the increased vulnerability for addiction to other substances of abuse later in life that most epidemiological studies have reported for people who begin marijuana use early in life.47 It is also consistent with animal experiments showing THC's ability to "prime" the brain for enhanced responses to other drugs.48 For example, rats previously administered THC show heightened behavioral response not only when further exposed to THC but also when exposed to other drugs such as morphine—a phenomenon called cross-sensitization.49"

In the case of e-cigarette experimentation, there is no evidence of a mechanism by which use of a highly flavored and sweet-tasting product would lead youth to be dissatisfied and craving for a harsher and less tolerable alternative. In fact, conceptually, there is evidence that regular vaping is likely to be protective against smoking initiation. The existing evidence suggests that most youth vapers are doing so because they enjoy the flavorings, rather than because they are deriving pleasure from any kind of nicotine hit or reward. The Monitoring the Future survey revealed that the majority of youth who use e-cigarettes report that they vape flavored e-liquids that do not contain nicotine. It appears, then, that nicotine is a minimal if not non-existent reason for youth e-cigarette experimentation. Thus, the hypothesis that youth use e-cigarettes, become addicted to the nicotine, are not satisfied enough with vaping and feel the need for something more hard-core, and therefore progress to cigarette smoking is dubious at best, and at worst, is a little on the ridiculous side.

At very least, it would necessary to demonstrate that a significant number of youth who experiment with e-cigarettes are in fact addicted to nicotine. So far, I'm not aware of a single study which has demonstrated that a single youth vaper is addicted to nicotine. We're not even sure that a substantial proportion of youth who vape are using nicotine-containing products in the first place. Nor is there any evidence that the delivery of nicotine from the products that youth are using is sufficient to create and sustain nicotine addiction. In fact, studies of nicotine delivery indicate that with most e-cigarettes, it is not conducive to creating addiction because there is no significant spike in blood nicotine levels such as to create a "hit" or a psychological reward that would lend itself to a propensity for addictive behavior.

There is a second problem with the study which deserves mention, although even without this second problem the study conclusion would be invalid.

This second problem is that smoking initiation was measured by any experimentation with cigarettes, even if just a puff. So many of the youth in the sample may have puffed on a single e-cigarette at baseline and then puffed on a single cigarette some time over the next year and that would be considered as providing evidence that e-cigarettes are a "gateway" to smoking. I provide this example only to show how flimsy the study conclusions are. In reality, I would actually expect to see higher rates of actual smoking initiation and sustained, regular smoking among youth who at baseline had experimented with e-cigarettes, and that would not provide evidence of a gateway effect. In fact, such a finding would be entirely consistent with the hypothesis that it is the failure of youth to become regular vapers that predisposes them to try smoking. It is still entirely possible that youth who become regular vapers are somewhat immune from smoking because it becomes very difficult to switch from a sweet, flavored product to a harsh, real cigarette like a Marlboro.

Although I disagree with the study conclusions, I do want to note that I agree with the overall study recommendations, which include providing education to youth about the potential health risks of both vaping and smoking, taking efforts to keep e-cigarettes out of the hands of youth, and restricting marketing of vaping products to youth. These actions should be taken regardless of whether e-cigarettes are a gateway to smoking or not.

Nonetheless, I'm afraid this study is going to do significant damage because anti-smoking groups are going to use this to convince the public and policy makers that e-cigarettes are a gateway to smoking, and this is going to lead to the continued promulgation of irrational policies that promote cigarette smoking by discouraging vaping. The media are already reporting this study as having proved that e-cigarettes are a gateway to smoking. It's almost impossible to get the cat back in the bag. Even if people now know "the rest of the story."

Thursday, August 18, 2016

Johns Hopkins Physician and Vaping Opponent Urges Parents to Lie to their Kids About the Hazards of Smoking

A physician with the Johns Hopkins All Children's Hospital, who is apparently a strong opponent of vaping, has advised parents to lie to their children about the hazards of smoking in order to dissuade them from using electronic cigarettes. Specifically, she urges parents to downplay the hazards of smoking so that kids will think that vaping is just as dangerous as smoking and will therefore avoid it at all cost.

According to a post on the hospital web site: "E-cigarettes may appear to be a safer way to smoke, but they are just as dangerous for children. ... Scientists are just beginning to see the dangerous effects of vaping, such as cancer. ... If parents use these products, they are strongly recommended to quit and keep all smoking accessories out of reach, especially for younger children. “Most importantly, parents should talk to their children about the dangers and harmful side effects of e-cigarettes and others drugs,” says Dr. Dawkins. “Parents should also consider vaping just as dangerous as smoking cigarettes when talking to their teens about the dangers of tobacco use and smoking.”"

The Rest of the Story

While I agree that children should be urged not to use electronic cigarettes, by no means do I agree that parents should lie to their children about the relative hazards of vaping vs. smoking in order to scare their kids away from these products. What this physician is suggesting is that parents should actually downplay the hazards of smoking by equating them with those of vaping, in the hope that this will scare kids away from e-cigarettes.

This advice is inappropriate not only because we in public health and medicine should never encourage parents to lie to their children about health risks, but also because it undermines decades of public education about the severe health hazards of cigarette smoking. If cigarettes are no more hazardous than vaping products, then cigarettes aren't all that bad for you. After all, Vuse and Mark Ten e-cigarettes, along with several other brands, have been documented not to contain any detectable amounts of hazardous chemicals and appear to be associated with only minimal risks. Do we really want our next generation to believe that smoking is no worse than inhaling a few flavorings, devoid of any tobacco and not involving any combustion?

As much as we might want to dissuade youth from vaping, I don't believe we can justify asking parents to lie to their children in order to try to accomplish this. Moreover, I don't believe that we need to rely on lies. I think the truth is sufficient. I also think that telling kids the truth will be more effective than lying to them. In addition, parents risk losing their kids' trust if it becomes apparent that they are lying (as it certainly will to many kids who aren't going to be tricked into believing that inhaling from a tube that contains no tobacco is more dangerous than smoking).

To make matters worse, the hospital itself is lying to the public by stating that vaping causes cancer. There is no evidence to support this. Vaping has never been shown to be associated with cancer in any animal or in any clinical study. There is no more support for claiming that vaping causes cancer than there is for telling the public that furniture causes cancer or that eating peanut butter causes cancer.

It is difficult to understand this apparently extreme need among vaping opponents to lie. But perhaps this need becomes clearer when you consider how little vaping opponents have to support their position. About the worst thing they can truthfully tell the public is, as the Johns Hopkins All Children's Hospital says in its post, that e-cigarettes "are not harmless." That isn't a very strong indictment. You could say the same thing about drinking coffee, eating Vienna Fingers, or playing Pokemon Go.

Therefore, all vaping opponents can do if they want to scare people and to demonize vaping is to lie about it. I find it unfortunate that in the process, they are downplaying the hazards of smoking and undermining decades of public education and awareness. Most unfortunate, however, is the fact that they are risking losing the public's trust to accomplish their aims.

Tuesday, August 16, 2016

Vaping Opponents Continue to Just Make Up the "Facts"

In apparent desperation because the actual facts do not support their vigorous opposition to vaping, anti-vaping advocates continue to simply make up the "facts" as they go along.

Just last week, a professor at Eastern Tennessee State University was quoted in an article in the Johnson City Press as stating that the increase in youth e-cigarette use means that vaping is bringing in new smokers.

According to the article: "Dr. Hadii Mamudu, an East Tennessee State University assistant professor in the school’s College of Public Health, is a world-wide recognized expert on this topic. One of his biggest evidence-based concerns, which have been somewhat addressed in the new regulations, pertain to the unsettling trend that more youth are taking to e-cigarette use, whereas they might not have come into tobacco use otherwise. “A North Carolina survey suggests that youth use rates increased from 1.1 percent to about 8 percent between just 2011 and 2013,” Mamudu said. “It’s very, very quick. And that’s troubling that it’s bringing in new smokers.” ... It’s partly generational, Mamudu said, and it’s frustrating that when tobacco experts were making progress against tobacco use in recent decades, e-cigarettes came along to cut into their gains."

The Rest of the Story

I am aware of no evidence that vaping is bringing in new smokers. What it is doing is bringing in new vapers. But there is no evidence that vaping is easing the transition to becoming a smoker. If anything, the evidence suggests the opposite. While e-cigarette use skyrockets, youth smoking has plummeted to its lowest historical level.

It is not even conceptually reasonable to suggest that e-cigarette use brings in new smokers. The e-cigarettes that youth are using are heavily flavored products and after getting used to the sweet and tasty flavorings, it is difficult to imagine that a youth would then find a Marlboro attractive. The truth is that youth who really do take up vaping are likely going to find it much more difficult to transition to smoking.

But the lack of evidence - either empirical or conceptual - is not stopping vaping opponents from simply making up the facts as they go along. Apparently, the truth is not enough to support their vigorous opposition to vaping. When the truth is not on your side, your only resort is to manufacture, make up, or distort the facts to support your position.

There is another possibility as well. It is possible that when he says that e-cigarettes are bringing in new smokers, the professor means that vapers are smokers - in other words, that vaping is a form of smoking. But that is obviously false, as vaping involves no combustion, produces no smoke, and does not even involve the use of tobacco.

Either way, anti-vaping advocates continue to intentionally mislead and deceive the public. It is unfortunate that vapers cannot trust tobacco control and health groups to provide accurate information. They can't even trust national health agencies like the CDC and FDA. The only place they can turn for accurate information is to the vaping community itself.

Monday, August 15, 2016

FDA Bans Safety Improvements in E-Cigarettes and American Lung Association Supports this Unprecedented Regulatory Blunder

Last Monday, the U.S. Food and Drug Administration (FDA) committed one of the most bone-headed blunders I have ever witnessed in public health. The agency's Center for Tobacco Products (CTP) banned all safety improvements for electronic cigarettes and vaping products.

This means that e-cigarette and e-liquid manufacturers can make no further improvements in the safety of their products, even if they become aware of severe and potentially life-threatening product defects.

NOTE: This is not a parody, and you are not reading The Onion. This is the actual regulation that the FDA put into effect on August 8th.

In order to make a safety improvement, an e-cigarette manufacturer would have to complete a burdensome and extensive pre-market tobacco application (PMTA), a process that is expected to take two years and to cost at least $5 million. This is obviously not an expense that more than 4 or 5 of the companies could afford. And even if they could afford the capital expense, it would still be another 2 years that their known defective product is required to stay on the market.

For example, let's say that a company tests its e-liquid using a more sensitive mass spectrometer and finds that it contains diacetyl, a chemical that has been linked to "popcorn lung," a severe and possibly fatal lung disease. The FDA regulations prohibit the manufacturer from removing the diacetyl from the e-liquid. If the company changes the ingredients of the e-liquid, it would be considered a "new" tobacco product and would therefore require a PMTA. The FDA regulations essentially require the company to continue selling its product with this toxic chemical, rather than to remove it.

Similarly, suppose that a company finds that by switching to a dual coil system, it can lower the unit's heating level and eliminate the formation of formaldehyde, a known carcinogen. The FDA regulations prohibit the manufacturer from making this change. In essence, the FDA is forcing the company to continue selling its product with the carcinogen, rather than to take this simple design measure to eliminate the carcinogen.

You may be wondering: How can this possibly pass Constitutional muster? How can the FDA possibly justify a regulation that - on its face - harms the public health by preventing safety improvements in a consumer product?

The answer is that it cannot justify the regulation. There are only costs - and no benefits - of the prohibition on safety improvements. The FDA has clearly violated the Administrative Procedure Act  by failing to provide a cost-benefit analysis, and the regulation is arbitrary and capricious and serves no legitimate government purpose. But the legal challenges to this regulation will take months (if not years), and in the meantime, the regulation's prohibition on safety improvements remains in effect (unless a judge issues an injunction that prevents enforcement of the regulation while it the issue is being litigated). 

The Rest of the Story

To me, the most surprising aspect of this story is not so much that the FDA blundered by enacting a regulation that immediately and irreparably harms the public's health. The most surprising part of the story is that this move was supported by virtually every national, anti-tobacco organization, including the American Lung Association, which actually praised the ban on safety improvements in e-cigarettes.

How could a ban on safety improvements possibly be a good thing for public health?

The only thing that the American Lung Association is protecting is smoking and continued tobacco use. They lobbied for a policy that actually inhibits the transition away from tobacco products and helps to preserve cigarette sales and cigarette company profits.

Jacob Sullum succinctly summarized the problem in a column last week at  

"The Food and Drug Administration’s e-cigarette regulations, which took effect this week, immediately struck two blows against public health. As of Monday, companies that sell vaping equipment and the fluids that fill them are forbidden to share potentially lifesaving information about those products with their customers. They are also forbidden to make their products safer, more convenient, or more pleasant to use. The FDA’s censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA’s requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business and force those that remain to shrink their offerings, dramatically reducing competition and variety. All of this is unambiguously bad for consumers and bad for public health." 

The rest of the story is that e-cigarettes pose such a threat to the paradigm of tobacco control advocacy that national organizations like the American Lung Association have completely lost their judgment. The sheer fear of a non-tobacco-containing product that could provide satisfaction to smokers without killing them is too much to bear. Ironically, it is the efficacy and health advantages of e-cigarettes that represent the greatest perceived threat to the survival of the mantra of groups like the American Lung Association. And they are fighting to protect that mantra, even at the expense of abandoning the fight against tobacco-related disease and death.

Tuesday, August 02, 2016

FDA Tobacco Center Director to Ex-Smoking Vapers: You Don't Exist

According to an article in yesterday's Winston-Salem Journal, the head of the FDA's Center for Tobacco Products (CTP) told the hundreds of thousands of ex-smokers in the U.S. who successfully quit smoking by switching to vaping that: "there is no definitive support of e-cigs playing a cessation role."

In other words, Mr. Zeller--the CTP director--is telling vapers that they don't exist, that their experiences never happened.

This will come as news to the hundreds of thousands of vapers in the U.S. who did successfully quit smoking by switching to vaping. Survey data suggest that the actual number of ex-smokers who quit smoking by using e-cigarettes may be greater than a million, but even with the most conservative assumptions, no fewer than hundreds of thousands of ex-smokers quit thanks to vaping. But to the FDA, these people apparently do not exist. 

The Rest of the Story

I have already explained why the abundant "anecdotal" evidence that e-cigarettes have helped hundreds of thousands of smokers to quit does constitute definitive support of e-cigarettes playing a cessation role. To ignore this evidence is to ignore the experiences of vapers throughout the United States and to deny their existence.

What an insult! It's like slapping these ex-smokers in the face and telling them that they don't count. Imagine if you told your doctor that you took up swimming and as a result you lost 15 pounds, and then your doctor responded, not by congratulating you, but by telling you there is no definitive evidence that swimming can help people lose weight. But you are that evidence.

It would have been one thing if the FDA had stated that there is not sufficient evidence to quantify the proportion of smokers who successfully quit using e-cigarettes or that we don't yet have enough clinical trial information to definitively compare the efficacy of e-cigarettes with that of nicotine replacement therapy or other smoking cessation drugs. But that's not what the FDA said. They said that there's no evidence that e-cigarettes play a role in smoking cessation.

That is quite obviously wrong. We know that e-cigarettes can and do play a role in smoking cessation. The question now is how big of a role? We have some idea of the number of smokers who quit by using e-cigarettes. What we don't know is how many smokers tried to quit using these products. Therefore, we can't quantify the proportion of quit attempts with e-cigarettes that were successful.

Unlike the FDA, I congratulate and applaud the vapers throughout the country who have been able to quit smoking using these products, as well as the vapers who have been able to reduce their cigarette consumption through dual use of e-cigarettes and tobacco cigarettes. Dual use, for many, is a pathway to complete smoking cessation and it has health benefits in terms of reducing the risk of cancer and lung disease as well as in lowering the level of nicotine addiction and making it easier to subsequently get off tobacco cigarettes altogether. Also unlike the FDA, I do not deny your existence or your experience. Instead, I value it because it lights a path forward for literally millions of smokers who have been unsuccessful in quitting using "FDA-approved" cessation methods.

Monday, August 01, 2016

Hiding the Truth from the Public: American Lung Association is Undermining the Public's Knowledge of the Hazards of Smoking

Last month, the American Lung Association (ALA) issued a warning about "popcorn lung" (bronchiolitis obliterans), telling the public that electronic cigarettes can cause this severe disease because the aerosol contains diacetyl, a chemical that has been linked to the development of popcorn lung in highly exposed popcorn workers who were exposed to diacetyl present in the butter flavoring. The Lung Association's statement was entitled: "Popcorn Lung: A Dangerous Risk of Flavored E-Cigarettes."

According to the American Lung Association: "When inhaled, diacetyl causes bronchiolitis obliterans - more commonly referred to as "popcorn lung" - a scarring of the tiny air sacs in the lungs resulting in the thickening and narrowing of the airways. While the name "popcorn lung" may not sound like a threat, it's a serious lung disease that causes coughing, wheezing and shortness of breath, similar to the symptoms of chronic obstructive pulmonary disease (COPD). Even though we know that diacetyl causes popcorn lung, this chemical is found in many e-cigarette flavors. It is added to "e-juice" liquid by some e-cigarette companies to complement flavorings such as vanilla, maple, coconut and more. So while diacetyl was swiftly removed from popcorn products since it could cause this devastating disease among factory workers, e-cigarette users are now directly inhaling this harmful chemical into their lungs."

The Rest of the Story

It is important to consider not merely what the American Lung Association is telling you, but what they are not telling you.

While the ALA is warning the public that e-cigarette aerosol contains diacetyl and can cause popcorn lung, here is what they are not telling the public:

Cigarette smoke also contains diacetyl, but the average estimated daily exposure to diacetyl from smoking is  about 750 times higher than that from vaping.

So why isn't the American Lung Association also warning the public that smoking can cause popcorn lung? And why aren't they calling on the FDA to require cigarette manufacturers to remove the diacetyl from their products?

Why the cover-up?

And by the way, this cover-up is not unique to the American Lung Association. I was unable to find a single anti-tobacco organization or health agency that is warning the public about the risk of popcorn lung from smoking or even mentioning that cigarette smoke contains high levels of diacetyl.

Sadly, this cover-up is having devastating consequences. For one, it is causing many smokers who were thinking about quitting to continue smoking instead. These smokers were scared away from switching to electronic cigarettes because they were frightened by the possible risk of developing popcorn lung. Clearly, had they known that the cigarette smoke they are inhaling exposes them to 750 times the amount of diacetyl than vaping does, this would have actually enhanced, rather than demolished, their incentive to quit smoking.

In addition, the cover-up is causing ex-smokers to return to smoking. These former smokers, who quit using e-cigarettes, are returning to smoking because they are frightened by the risk of popcorn lung. Again, had they known that the cigarette smoke they are inhaling exposes them to 750 times the amount of diacetyl than vaping does, this would have enhanced, rather than demolished, their chances of quitting smoking.

It is not entirely clear whether smoking itself causes popcorn lung in the first place. Pierce et al., in a 2014 article, noted that "smoking has not been shown to be a risk factor for bronchiolitis obliterans." However, since the symptoms of popcorn lung are similar to those of COPD, it may be that smokers who develop popcorn lung are thought to have COPD, so the popcorn lung is not diagnosed. If that is the case, then the risk of developing popcorn lung from smoking is still going to be astronomically higher than the risk of developing popcorn lung from vaping because the diacetyl exposure is so much higher.

Apparently, the anti-tobacco groups are on a mission to demonize electronic cigarettes, even if that comes at the expense of promoting cigarette smoking.

Thursday, July 28, 2016

FDA Claims It Is Protecting Public Health by Keeping Slightly Altered Cigarettes Off the Market

Earlier this month, the FDA's Center for Tobacco Products (CTP) denied a substantially equivalent order for Maverick Menthol Silver Box 100s cigarettes. This means that this cigarette brand can no longer be marketed and sold in the U.S. By definition, a "not substantially equivalent" order means that the FDA has deemed that the product raises different questions of public health than cigarette brands already on the market in 2007.

Last year, CTP denied substantially equivalent orders for four Reynolds American brands: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes.

The director of FDA's CTP - Mitch Zeller - boasted that these orders will help protect the public's health by making sure that cigarette products meet "the public health bar set forth under law." These orders will "protect the public from the harms caused by tobacco use," he said:

"These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use. The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law."

The Rest of the Story

You can't be serious. This has to be some kind of nasty joke. How could the FDA possibly claim that by keeping these slightly altered brands off the market the agency is helping to protect the public from the harms caused by tobacco use? Is the FDA under the impression that the current cigarettes on the market are substantially healthier than these five slightly altered cigarettes, such that the new products don't reach "the public health bar," but the existing cigarettes do? How can the agency even suggest that one brand of combustible cigarette raises substantially different questions of public health than another? What the agency is saying is that some cigarettes on the market are safer than others.

What makes these rulings and statements even more ridiculous is that while the FDA apparently believes that slight variations in a cigarette may make that cigarette substantially healthier or more dangerous, the agency does not believe that completely eliminating the tobacco and completely eliminating the combustion process (i.e., an e-cigarette) makes a "cigarette" any safer. In fact, the agency has stated that it has not made a determination that e-cigarettes are any safer than combustible tobacco cigarettes which are killing more than 400,000 Americans each year.

This is an embarrassment. Our nation's leading medical and health regulatory agency believes that slight variations in a cigarette can make such a product substantially healthier, but the complete removal of the tobacco and elimination of the combustion may not have any effect on the safety of the product.

The FDA's official, stated position on the relative safety of tobacco vs. tobacco-free cigarettes is as follows: "There may be a perception that electronic cigarettes...are safer alternatives to conventional tobacco products. ... However, FDA is not aware of any scientific data to support those perceptions."

But apparently the agency does believe that minor differences in combustible tobacco cigarettes make some substantially safer than others, so that they raise different questions of public health. 

If I didn't know this was true, I would absolutely think that I was reading an Onion article.

Wednesday, July 27, 2016

Study Demonstrates Low Health Risks Associated with "Secondhand Vapor" from E-Cigarettes

A study published in the journal Nicotine & Tobacco Research demonstrates that "secondhand vapor" from e-cigarettes poses very little risk to bystanders.

(See: Czogala J, et al. Secondhand exposure to vapors from electronic cigarettes. Nicotine & Tobacco Research 2014; 16(6):655-662.)

The study methods were as follows: "We measured selected airborne markers of secondhand exposure: nicotine, aerosol particles (PM(2.5)), carbon monoxide, and volatile organic compounds (VOCs) in an exposure chamber. We generated e-cigarette vapor from 3 various brands of e-cigarette using a smoking machine and controlled exposure conditions. We also compared secondhand exposure with e-cigarette vapor and tobacco smoke generated by 5 dual users."

The results were as follows: "The study showed that e-cigarettes are a source of secondhand exposure to nicotine but not to combustion toxicants. The air concentrations of nicotine emitted by various brands of e-cigarettes ranged from 0.82 to 6.23 µg/m(3). The verage concentration of nicotine resulting from smoking tobacco cigarettes was 10 times higher than from e-cigarettes (31.60±6.91 vs. 3.32±2.49 µg/m(3), respectively; p = .0081)."

The study demonstrated that both in an experimental chamber and with actual vaping taking place, there were low concentrations of nicotine, transient increases in fine particulate matter, no increase in carbon monoxide levels, and no exposure to volatile organic compounds. The authors conclude that although "secondhand vaping" is associated with low-level nicotine exposure, it does not result in exposure to toxic tobacco-specific combustion products.

The Rest of the Story

In spite of these findings, which demonstrate that secondhand vaping is not a significant health threat, Dr. Stan Glantz has nevertheless informed the public that the study provides evidence that "e-cigarettes pollute the air and expose bystanders."

According to Dr. Glantz, the study found that "e-cigarettes pollute the air with nicotine and fine particles." His argument that secondhand vapor is a health hazard is based on the finding that vaping results in exposure to nicotine and fine particles.

Here is why Stan's argument is faulty:

Nicotine exposure: First, let's quantify the exposure to nicotine for a bystander. Assuming the highest nicotine level detected (6.2 micrograms per cubic meter), a breathing rate of 600 liters/hour and exposure of a full work-day (8 hours), the nicotine exposure will be 4.8 times 6.2, or about 30 micrograms per day. This is the equivalent of 0.03 cigarettes per day. Even if you were exposed for 8 hours every day for a year, your total nicotine exposure would amount to the equivalent of only 11 cigarettes.

Obviously, this is an extremely low level of nicotine exposure, and it is not going to pose any significant health risk.

Fine particle exposure: The average particulate exposure from vaping (152 micrograms per cubic meter) was more than 5 times lower than particulate exposure from secondhand smoke (819 micrograms per cubic meter). But even more importantly, the exposure to particulate matter from vaping was only transient, as the vapor particles dissipated within minutes. In contrast, smoke lingers and so exposure to the particulate matter is constant. The overwhelming majority of time that a bystander is in the room with the vaper, the bystander is not being exposed to particulate matter. Thus, fine particle exposure from vaping is dramatically lower than with smoking, and is unlikely to pose significant health risks.

Why then, are anti-tobacco advocates presenting these results differently? I believe it's because the findings are not consistent with their pre-conceived conclusion that both vaping and secondhand vaping are substantial health hazards. The only way to preserve the pre-existing ideology is to twist the results to fit the ideology, rather than to change the ideology to fit the science.

Monday, July 25, 2016

FDA's Convoluted Response to a Simple Question Shows How Arbitrary, Capricious, and Inane the Deeming Regulations Are

Someone shared with me the actual reply they received from the FDA in response to a very simple question:

"Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations?  If so, will they also require pre-market approval like products that do contain nicotine?"

This seems like a simple and straightforward question that could and should be able to be answered with a simple "yes" or "no." After all, if e-cigarettes do not contain nicotine then there is no basis for the FDA to assert jurisdiction over them as tobacco products. Therefore, these nicotine-free e-liquids would not be subject to the pre-market approval requirements.

A simple answer of "no" would have and should have sufficed.

The Rest of the Story

Instead, here is the FDA's actual response:

Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, “Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act” (Deeming rule).  The information contained in this message is what is provided to vape shops to assist them with any questions about compliance.  We hope that you find this helpful.

FDA anticipates that newly regulated businesses may have many questions and compiled this e-mail as a resource to help you better understand the Deeming rule and the potential impact to your business.  We encourage you to review this information and keep checking our website for new information such as compliance training webinars and updates based on questions FDA receives.

It may be useful for you to know that the Deeming rule published in the Federal Register on May 10, 2016, and takes effect on August 8, 2016.  While FDA continues to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products, the Deeming rule extends FDA’s authority to “newly deemed” tobacco products such as electronic cigarettes, cigars, hookah, and pipe tobacco, as well as their components and parts, but not the accessories of newly deemed products. The Deeming rule also includes additional restrictions for “covered tobacco products.”  A “covered tobacco product” is any newly deemed tobacco product, but excludes any component or part that is not made or derived from tobacco.

The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product.  Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer. 

The rule will subject all manufacturers, importers and/or retailers of newly-regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated since 2009.  

These requirements include:
  • Register domestic manufacturing establishment(s) and submit product listings to FDA by December 31, 2016;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
Manufacturers of newly-regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

For products that were not on the market as of the effective date, a premarket authorization is required prior to marketing those products.  For products on the market as of the effective date, under staggered timelines, the FDA does not intend to enforce the premarket review requirements for up to three years while manufacturers submit – and the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise the product will be subject to enforcement.

FDA does not assess fees associated with the requirements identified above. The costs associated with compliance with these requirements may vary based on the type and complexity of the product, and, as a result, FDA is not able to provide an individualized estimate of costs that you may incur. However, FDA has included in the preamble to the Deeming rule its estimates of the quantified costs associated with the Rule over 20 years, as well as estimated hourly burdens on impacted entities (such as tobacco product manufacturers) for the requirements described above. Please see the links provided below for more information.

As it relates to e-liquids that contain zero nicotine, generally, if your zero-nicotine product is not made or derived from tobacco, it may still be a tobacco product subject to FDA regulation if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product; or intended or reasonably expected to alter the performance, composition, constituents, or characteristics of a tobacco product (with certain exceptions relating to controlling moisture or temperature for storage and initiating external heat source), your product is subject to FDA regulation.  These products will be evaluated on a case-by-case basis.  This applies to closed and open system devices that contain zero-nicotine.

As a tobacco product, your product will automatically be subject to all of the requirements in Chapter IX of the Federal Food, Drug, and Cosmetics Act and its implementing regulations relating to tobacco products when the deeming rule becomes effective on August 8, 2016.  However, for many provisions FDA is providing a compliance period with additional time during which FDA does not intend to enforce compliance with the requirements, as stated in the final rulemaking document.

In addition, if you’re solely a supplier and your zero-nicotine product is sold only to another company for further manufacture into a finished tobacco product, at this time, FDA does not intend to enforce certain automatic provisions of the law with respect to your product.  Therefore, for example, FDA does not intend to enforce the requirement that you register your manufacturing establishment and list your products, submit premarket applications, or submit ingredient listings or health documents.

There are additional requirements in the rule, such as minimum age, identification, and vending machine restrictions and health warning requirements that apply only to “covered tobacco products,” which does not include a component or part that is not made or derived from tobacco.  Accordingly, if your product is not made or derived from tobacco, it is not subject to such requirements.  Even if your product is not a covered tobacco product, however, FDA regulations prohibit you from distributing free samples of your newly-regulated product, including its components and parts, to anyone.
Regarding your fourth question, if the product does not contain nicotine and you have submitted a statement to FDA certifying so, according to the regulatory requirement, then you would not have to include the mandatory warning regarding the contents of nicotine in the product.
For More Information
To assist the newly-regulated tobacco industry in complying with the requirements, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

Final Rule and Accompanying Documents
Resources for Additional Information
FDA continues to update its Deeming webpage to provide information designed to help industry understand the Deeming rule.  We anticipate that many of your questions will be addressed by the resources available on this website.  We plan to soon add a chart that may help you determine which provisions apply to you and the timeframes for complying.  In addition, FDA plans to post Tobacco Compliance Webinars, including one specifically addressing requirements for vape shops, to our website and updates will be provided as additional webinars are available. 

We also encourage you to subscribe to FDA’s “This Week in CTP.”  By subscribing, you’ll receive updates about regulatory activities, retailer notices, upcoming events, and public education campaigns.

Should you have further questions after reviewing this information, you may contact CTP using the following communication methods:

Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD  20993

Center for Tobacco Products
Food and Drug Administration
CTP Call Center: 1-877-CTP-1373

What Does This All Mean?

Despite having 11 years of post-secondary school education and a great deal of experience reading and interpreting legislation and regulations, I have no clue what the heck the FDA is talking about. I can't even imagine a scenario where a nicotine-free e-liquid would be incorporated into a "tobacco product," but if it were, it would only be a tobacco product if it was mixed with nicotine-containing e-liquid, in which case the manufacturer or retailer is not selling a nicotine-free e-liquid. Of course that would be considered a tobacco product.

The question here was much simpler. If I produce a finished e-liquid that is nicotine-free, is my product regulated and if so, do I have to submit a pre-market application? The answer appears to be no. But the FDA hides this answer in such a stream of incomprehensible jibberish that the poor small business owner (or even the large business owner) is more confused after having asked the question than they were before.

The time and resources necessary to even understand what is regulated and what is not regulated are prohibiting for most small business owners in the vaping market. And that's before even getting to the issue of what would be required in a pre-market application if the product is regulated.

This is quite obviously a nonsensical and non-workable regulatory approach and for that reason alone, it is not going to protect the public's health. Quite the opposite, it will harm the public's health by decimating the e-cigarette market, forcing thousands of owners of small entities out of business, and protecting real cigarettes from competition, thus increasing smoking-related disease and death.

In my opinion, this response from the FDA could be used by the plaintiffs in litigation against the agency in order to demonstrate the arbitrariness and capriciousness of the regulations, as well as their undue complexity and burden on small business owners.

So in response to the FDA's expressed hope to the inquiring business owner that "We hope that you find this helpful," I say: "Yes. Very helpful indeed."

Friday, July 22, 2016

Great Article on Vaping

This is one of the best articles on vaping that I've read. It makes a difference to have a young person's perspective because they are in the best position to have insight into the nature of smoking and vaping behavior among their peers.

Thursday, July 21, 2016

CDC Bemoans Failure to Decrease Overall Alcohol Product Use among Teens, Despite Large Decline in Current Drinking

According to data from the Centers for Disease Control and Prevention (CDC), the prevalence of current drinking among high school students has declined dramatically in the past decade and a half, dropping from 50.0% in 1999 to 34.9% in 2013. One would think that would be cause for celebration. However, the CDC is telling the public that despite this decline in drinking among youth, overall use of alcohol products has stayed the same.

The Office on Alcohol and Health issued a statement yesterday, arguing that the recent declines in youth drinking have been undermined and offset by an increase in the use of new and emerging types of alcohol product use. These products, which look just like traditional alcohol drinks and are consumed in a similar way, threaten the public's health according to CDC because they look like traditional alcohol drinks and are therefore re-normalizing drinking and serving as a gateway to traditional alcohol use.

However, an investigation by The Rest of the Story has revealed that the drinks which CDC is now classifying as "alcohol products" do not actually contain alcohol. In fact, our investigation revealed that these products were created with the specific intention of providing youth with beverages that look like alcohol products and are consumed the same way, but which are much safer because they don't actually contain alcohol.

By submitting a Freedom of Information Act (FOIA) request, we were able to determine that the CDC has rigged the numbers for the past five years by starting to classify alcohol-free beverages as "alcohol products." For example, the CDC now considers Shirley Temples to be alcohol products. Other beverages that the CDC now classifies as alcohol products include alcohol-free spritzers, alcohol-free Sangria, sparkling (non-alcoholic) limeade, and non-alcoholic watermelon/strawberry coolers.

Anti-alcohol groups throughout the U.S. have uniformly condemned Shirley Temples. In fact, one group released a report just yesterday entitled "Shirley Temples are Destroying America's Youth."

The Rest of the Story conducted an exclusive interview with the CDC about their new classification system. Here are excerpts from the interview:

Rest of the Story: Aren't you pleased with the recent declines in youth drinking? Wouldn't you say that is a public health accomplishment?

CDC: Unfortunately, the dramatic decline in youth drinking of traditional alcoholic beverages has been offset by an increase in youth use of novel alcohol products, such as Shirley Temples and non-alcohol spritzers. Drinking among high school students dropped to the lowest levels since the National Youth Risk Behavior Survey (YRBS) began in 1991, but the use of other alcohol products,  including Shirley Temples, among students poses new challenges.

Rest of the Story: But I don't understand. How can you classify Shirley Temples and other non-alcoholic beverages as "alcohol products" when they don't actually contain alcohol? Isn't that being dishonest, or at least, disingenuous?

CDC: Current drinking is at an all-time low, which is great news. However, it’s troubling to see that students are engaging in new risk behaviors, such as drinking Shirley Temples and alcohol-free sangria. We must continue to invest in programs that help reduce all forms of alcohol use, including Shirley Temples, among youth.

Rest of the Story: But what is the problem with youth drinking alcohol-free beverages? In fact, wouldn't we rather that youth drink alcohol-free beverages than drinks that actually contain alcohol?

CDC: There are concerns that Shirley Temples contribute to normalizing drinking as a social norm and may be a gateway to youth drinking.

Rest of the Story: But isn't the goal to prevent youth drinking of alcohol?

CDC: During 2011–2015, there was no change in current use of any alcohol product among middle and high school students, and in 2015, an estimated 4.7 million U.S. middle and high school students currently used any alcohol product. As in 2014, Shirley Temples were the most used alcohol product among U.S. middle and high school students in 2015. During 2011–2015, substantial increases in Shirley Temple use among middle and high school students were reported, resulting in an estimated total of 3.0 million middle school and high school Shirley Temple users in 2015. Although youth drinking declined during 2011–2015, there was no change in use of alcohol products during this time period. Because of increases in the use of Shirley Temples, no decline occurred in alcohol use overall during 2011–2015.

Rest of the Story: Isn't there evidence that drinking Shirley Temples is much safer than drinking alcohol-containing beverages?

CDC: Youth use of alcohol in any form is unsafe. For this reason, comprehensive and sustained strategies are needed to prevent and reduce the use of all alcohol products among youths in the United States.

Rest of the Story: Is there actual clinical evidence that drinking Shirley Temples is unsafe?

CDC: Despite what many people believe, Shirley Temples are not just pure water. Furthermore, youth consumption of Shirley Temples will re-normalize drinking behavior. Policies to denormalize alcohol use in society and historic reductions in alcohol consumption may be undermined by this new 'gateway' product.

Rest of the Story: But how can consumption of alcohol-free beverages normalize the drinking of alcohol? Wouldn't that in fact de-normalize alcohol consumption?

CDC: Youth should not use any alcohol product. Moreover, there are other problems with Shirley Temple use. For example, these products may cause former drinkers to relapse to alcohol use. They also may delay the achievement of sobriety among current drinkers. It would be devastating if alcoholics were to substitute Shirley Temples for their drinking instead of quitting alcohol use entirely.

Rest of the Story: Is there anything else you would like to emphasize to the public?

CDC: Yes. Shirley Temples are not just harmless water, as the alcohol industry has been advertising.

Rest of the Story: Thank you for your time.

Recently, the Food and Drug Administration (FDA) promulgated regulations which "deem" alcohol-free beverages like Shirley Temples to be "alcohol products." Restaurants which serve Shirley Temples will now be considered alcohol manufacturers. In addition, other component parts of these beverages will also be regulated as alcohol products, including the glasses they are served in. After consultation with multiple legal experts, The Rest of the Story has confirmed that the cherries that are served with Shirley Temples are also regulated under these alcohol product rules.

We asked the FDA whether this means that companies which sell cherries must submit pre-market alcohol applications (PMAAs) to the agency before they market their cherries. We were referred to the FDA draft guidance, which indicates that cherries will only be regulated if they are part of a "finished alcohol product." This means that companies which sell cherries to restaurants and bars will not have to submit PMAAs. However, if a restaurant incorporates those cherries into a finished alcohol product (e.g., a Shirley Temple), then the restaurant is considered an alcohol manufacturer and will have to comply with the regulations, including the requirement to submit a PMAA.

Despite the concerns of highball glass manufacturers throughout the country, we have confirmed that these companies will not have to submit PMAAs unless they are selling finished alcohol products, meaning a complete Shirley Temple. However, restaurants that prepare their own Shirley Temples will have to conduct safety testing on their highball glasses. In addition, companies that sell pre-made Shirley Temples will be regulated as alcohol manufacturers. Restaurants and bars that sell pre-made Shirley Temple cocktails will not have to comply with the regulations, but those which self-mix the Shirley Temples themselves will have to comply.

Making the PMAA even more burdensome is the FDA's requirement that any variation in the contents of a Shirley Temple require a separate application. This means that restaurants and bars will need separate FDA approval for every different ratio of 7-Up to grenadine that they use in their drinks. Moreover, a separate application will be required for every combination of 7-Up/grenadine ratio and type of glass. Different varieties of cherries will also require separate applications and a separate determination that the Shirley Temple with that particular cherry variety is beneficial for the public's health. That determination must take into account not only the impact of Shirley Temples on individuals who already drink alcohol, but on non-alcohol users who might start drinking Shirley Temples.

One restaurant has filed suit against FDA, arguing that the agency grossly underestimated the number of PMAA submissions that will be required under the regulations. While the FDA estimates there will be only 750 applications, the owner of this restaurant told us that he alone will have to submit 96 separate applications, as they use four different ratios of 7-Up to grenadine, three different types of glasses, four varieties of cherries, and two types of toothpicks.

According to many restaurant owners, the most troubling aspect of the FDA deeming regulations is that they will not be allowed to inform patrons that Shirley Temples are free of alcohol, are safer than real alcoholic beverages, or to even use the term "alcohol-free." For example, restaurants can no longer list Shirley Temples under a menu category of "non-alcoholic beverages." Instead, Shirley Temples will now be lumped in under a general category of "alcoholic beverages," so this menu item will be mixed in with each restaurant's selection of bourbon, fine scotch, rum cocktails, and schnapps.

Tuesday, July 19, 2016

Groundbreaking Research Finds that Products which are Cool and New Appeal to Youths

Anti-Vaping Advocate Says this Finding Adds to Evidence that E-Cigs are a Gateway to Youth Use of Tobacco Products

A groundbreaking study published yesterday in the Canadian Medical Association Journal presents the shocking finding that youth are drawn to products that are new and cool and that this is why they find electronic cigarettes appealing.

The study, which involved a survey asking Ontario youth why they find e-cigarettes appealing, reported the startling finding that a major reason for youth e-cigarette experimentation is that they like "engaging in seemingly exciting new behaviours." The paper's final conclusion was that: "Adolescents in this population appear to be motivated by the appeal of trying something new."

In an accompanying editorial, Dr. Matthew Stanbrook argues that this study adds to evidence that e-cigarettes are a "gateway" to youth tobacco product use, stating that the findings "add to mounting evidence associating use of e-cigarettes with tobacco use." He also cited a recent study involving US youth which "found that never-smokers in grades 11–12 who used e-cigarettes had sixfold higher odds of becoming cigarette smokers a year and a half later when they reached the legal age to purchase tobacco."

The Rest of the Story

The international reaction to these remarkable and shocking new findings has been intense. Marketers throughout the world have expressed their surprise at these findings and are already looking to change their tactics to take advantage of this new knowledge.

For example, Apple CEO Tim Cook told The Rest of the Story that: "This is truly a game changer. We had no idea that cool, exciting, new products would appeal to youth. We've been hammering away at young people for years with the same old Apple 1's, thinking that they are totally into old-fashioned, traditional products. Cook said that the findings of the study instantly gave him the idea of launching a series of what he called "i" products, such as multi-functional cell phones, with new versions coming out each year to attract young people to innovative, new, and exciting features.

Sony CEO Kazuo Hirai was also surprised by the study findings. "No wonder our Betamax video recorders haven't been selling well among the young people. It never occurred to us that to attract youth, you have to come up with something new and exciting. This is going to change the way we do business."

The Rest of the Story also interviewed Nintendo CEO Tatsumi Kimishima, who told us that the findings of this study sparked a novel idea: "Instead of just providing kids with the old, kind of boring video games where you catch Pokemon while sitting on your couch, we're going to integrate the Pokemon game with high-tech GPS and state-of-the-art mapping technology. This will create the novelty of young people having to get off their couches and venture into the real world to catch Pokemon in real-life settings. According to this new research, the novelty and excitement of this activity should really catch on quickly." While Kimishima has not officially decided on a name for the product, he told us that he was preliminarily calling it "Pokemon on the Go."

The Rest of the Story also interviewed several tobacco control experts, asking them what aspect of the new study shed light on the gateway hypothesis. One researcher kept us on hold for four hours, while frantically searching the paper in a seemingly hopeless attempt to find anything in the study which was relevant to the question of whether e-cigarettes are a gateway to youth use of tobacco products.

Another researcher told us that he couldn't find anything, but was having the article translated into three other languages to see if perhaps he was missing something.

A third researcher declined our request for comment, explaining that it would take him six hours to download the article on his Apple 1. When asked why he is still using such an antiquated computer, he told us that he "doesn't like new, cool things. That's why I still write my papers with an Olivetti Lettera 32 manual typewriter, watch my favorite programs on a GE 17-inch TV set, and listen to music on my Victrola 3-speed turntable."

Physician Recommends Against Quitting Smoking for Smokers Who Do Not Want to Use NRT or Cessation Drugs; Hides Conflict of Interest

An article in the Annals of Family Medicine argues that smokers who do not wish to use nicotine replacement therapy (NRT), varenicline, or other drugs should be counseled by their physicians not to quit smoking. Specifically, these patients should not be encouraged to try to quit using e-cigarettes. Moreover, the article scares physicians into thinking that if they do encourage smoking cessation via e-cigarettes, they are putting themselves into legal danger.

According to the lead author - Dr. Adam Goldstein of the University of North Carolina - e-cigarettes are dangerous and have not shown to be helpful in smoking cessation and should therefore not be recommended to patients. If they are recommended, he argues, physicians face legal risks:

"the ethical duty of medicine is to do no harm. Jumping from the 10th floor of a burning building rather than the 15th floor offers no real benefit. If a clinician recommends penicillin for a resistant infection in the face of more effective therapy, they would face an uncertain defense in front of their colleagues or courts. For clinicians that do recommend ENDS, do they document such in the medical record? Given the rise in medical lawsuits related to ENDS side effects or injuries, until such time that medical evidence supports ENDS safety and effectiveness, and robust regulatory frameworks exist, clinicians who recommend ENDS to patients in favor of more effective and safe products may face medico-legal risks."

The authors also argue that e-cigarettes should not be recommended to subgroups of smokers: "Some clinicians may be tempted to recommend ENDS for certain subgroups of smokers, but this approach is problematic."

They specifically advise physicians to recommend that asthmatic smokers keep on smoking rather than attempt to quit using e-cigarettes: "It is problematic to recommend ENDS for asthmatic tobacco users, as immediate reduction in lung function is observed when using ENDS."

The Rest of the Story

By advising physicians not to recommend e-cigarettes for smoking cessation, this article is actually advising them to recommend that smokers who don't want to quit using FDA-approved methods should continue smoking, rather than trying to quit by switching to vaping.

This is a dangerous and misguided recommendation that is completely non-evidence-based and which is destructive to the health of patients by discouraging them from quitting smoking unless the quit using a particular method favored by the physician.

I cannot emphasize strongly enough that if a patient is not interested in quitting using NRT or another drug, he or she should be advised to find some other method of quitting, including e-cigarettes. That patient should not be thrown under the bus, as is being recommended in this article. Better that the patient attempt to quit using e-cigarettes than not try to quit at all. Moreover, if the patient expresses particular interest in e-cigarettes and a disdain for or previous failure with FDA-approved therapies, he or she should be strongly advised to go for it. Millions of ex-smokers have successfully quit using vaping products and there is no justification for promoting continued smoking over a quit attempt with e-cigarettes.

Not only is the medical recommendation in the article misguided and damaging, but the evidence presented to support it is highly biased and incomplete. The paper cites research which identified potential risks of vaping but fails to cite any of the many articles which have documented the significant benefits associated with switching to e-cigarettes.

For example, the paper cites two articles which found sub-clinical increases in airways resistance among e-cigarette users, but failed to cite two other articles which documented significant improvement in lung function among asthmatic smokers. The recommendation against asthmatic smokers trying to quit using e-cigarettes ignores solid evidence that asthmatic smokers experience dramatic improvement in their respiratory symptoms and clinical lung function if they are able to switch to e-cigarettes.

The paper also fails to cite the most important study of all: the one and only clinical trial conducted on e-cigarettes, which happened to find that these products are just as effective as the nicotine patch for smoking cessation.

Unfortunately, the bias apparent in the paper has the appearance of being related to an unreported conflict of interest. Specifically, the lead author - Dr. Goldstein - failed to disclose that he has received funding from Big Pharma; in particular, funding from a company that makes Chantix, for which e-cigarettes are a major market competitor. It is imperative that a physician who publishes a medical recommendation like this disclose any relevant conflicts of interest, especially prior funding from a company that stands to benefit tremendously from the recommendation being made.

By his own acknowledgment, Dr. Goldstein has received research funding from Pfizer, the maker of Chantix. Pfizer certainly stands to gain financially from the recommendation that physicians discourage patients from using e-cigarettes to quit. So this conflict should have been disclosed. It appears that Dr. Goldstein received a $500,000 grant from Pfizer from 2010-2012. I think that a half million dollar grant from a corporation which stands to gain financially from the medical recommendation made in the article is something that readers deserve being made aware of.

Elsewhere, Dr. Goldstein acknowledges that he has served on advisory boards for Pfizer and for Boehringer Pharmaceuticals. In addition, the UNC Nicotine Dependence Program, of which Dr. Goldstein is listed as a member, has received funding from Pfizer.

Monday, July 18, 2016

Altria Urges Changes in FDA E-Cigarette Regulations that Would Decrease Its Share of Vaping Market and Help Save Many Smaller Manufacturers

In a move that casts serious doubt on anti-tobacco groups' maligning of the motives of the tobacco companies in marketing vaping products, Altria Client Services, on behalf of Nu Mark (the maker of Mark Ten e-cigarettes), has submitted comments to the FDA that blast its pre-market tobacco application (PMTA) requirements for e-cigarettes, arguing that these requirements are unduly burdensome, unnecessary, and beyond the scope of the agency's jurisdiction under the Tobacco Control Act.

In the comments, Altria Client Services expresses particular concern that the burdensome PMTA requirements will force many manufacturers out of business, undermining the Tobacco Control Act's public health goals.

Altria writes: "The Draft Guidance is not aligned to the FSPTCA's goal of promoting public health because the complexity of information recommended for the application process and the short compliance period for FDA to complete PMTA reviews may result in some existing ENDS products being forced off the market."

Altria also notes that FDA itself acknowledged that a large number of e-cigarette companies would go out of business, yet failed to account for this in its regulatory impact analysis.

To remedy the situation, Altria suggests an approach similar to what I have been advocating: the agency should "establish baseline performance standards for ENDS products that, when met, would serve as the basis for an abbreviated or alternative marketing authorization pathway to satisfy the statutory PMTA requirements."

Two of Altria's main goals, as stated in the comments, are to:

1) "support manufacturers' efforts to develop and bring to market innovative products that may advance the public health."

2) "allow industry participants to engage and compete in a dynamic market."

The Rest of the Story

For tobacco control advocates and groups which continue to argue that the tobacco companies have failed to change their behavior, they need to check their calendars and realize that we're now in 2016, not in the pre-Engle time period. Things have changed substantially, and nowhere is this seen more noticeably than with the tobacco industry's embrace of true harm reduction products, especially e-cigarettes and vaping products.

Many of my colleagues continue to argue that Altria and Reynolds American are insincere in wanting to promote vaping, that they are merely trying to promote smoking by encouraging vaping as a mechanism to avoid smoking cessation, and that their main purpose is to try to recruit new smoking customers by getting youth addicted to e-cigarettes and then encouraging them to proceed on to tobacco cigarette smoking. Many of the anti-tobacco groups continue to accuse Altria and Reynolds American of marketing their products to youth and using slick advertising and youth-oriented flavorings like gummy bear and cotton candy to appeal to kids.

The truth is that these are not your father's cigarettes. What Altria and Reynolds American are doing with vaping products is nothing like what they used to do with the marketing of tobacco cigarettes.

In fact, Altria and Reynolds American are not offering youth-friendly flavors like bubble gum, cotton candy, and gummy bear. Their marketing is not targeted at youth, either in its advertising placement or content. Their sales practices for Vuse and Mark Ten are not directed at facilitating the youth purchase of these products.

Candy and fruit flavors: None prior to 2015. Only tobacco and menthol. Last year, introduced four new flavors: Mint, Chai, Berry, and Crema.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

Candy and fruit flavors: None before last year. Only tobacco and menthol. Last year, introduced two new flavors: Fusion and Mint.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

If these companies were truly going after kids, why would they be actively avoiding youth-friendly flavorings? Why would they refrain from selling disposable products, which are much less expensive and are most likely the type that youth purchase?

To be sure, there are a small number of "bad actors" in the e-cigarette industry. But Altria and Reynolds American are not among them.

Please note that I am not arguing here that companies which are selling e-cigarettes via the internet, marketing disposable products, or selling multiple flavors are targeting kids or that they have any desire for youth to use their products. Quite the opposite: these aspects of the market are essential to reach adult smokers and curtailing any of them would decimate the market, leading tens of thousands of ex-smokers to return to smoking and discouraging smokers from switching to vaping products in the future. I am simply pointing out that Altria and Reynolds American are clearly not targeting youth and using these points to demonstrate how inaccurate the anti-tobacco groups are in characterizing the behavior of these companies.

If there were any remaining doubt about the sincerity of the two major domestic cigarette companies in marketing vaping products, it should disappear after reviewing Altria's comments to the FDA. (First of all, recognize that these comments are not a publicity ploy because the company is not publicizing them -- I was unable to even find them online.) In these comments, Altria supports policy changes that are not in its best financial interests in the sense that the current burdensome regulations are in Altria's favor and without changes to make them less burdensome, these regulations would essentially hand the entire vaping market to Altria and Reynolds American. Virtually no other companies have the financial resources to develop the required PMTAs. So Altria could easily just sit by quietly and then enjoy an oligopoly in the vaping market.

But this is not what Altria is doing. The company is actually trying to save at least some vitality in the e-cigarette and vaping market by urging the FDA to weaken the burdensome requirements so that many more manufacturers have an opportunity to stay on the market. And these two tobacco companies are also strongly behind the Bishop-Cole amendment which would grandfather existing vaping products, thus preventing the decimation of the e-cigarette market and the creation of a Big Tobacco oligopoly.

Anti-tobacco advocates are going to have to come to terms with the apparently threatening reality that our long-term mantra is no longer valid. Their entry into the vaping market is not merely a ploy to get youth hooked on nicotine so that they can get new smoking customers. They are legitimately interested in creating a new and robust market for harm reduction products.

Now I am not arguing that financial incentives do not play a role. Of course they do. The companies see an eventual decline in the use of combustible tobacco products in the United States, and they want to be able to derive some economic benefit even as smokers move away from these combustibles. By entering the vaping product market, the companies have an alternative source of revenues to help sustain them. And they can use price increases with their traditional cigarettes to help lessen the financial blow, by protecting revenue even as sales decline. And while their market share will not be nearly as high in a robust, thriving vaping market, the overall market will likely be much greater if there are a large variety of alternative choices for smokers who want to quit but do not feel able to do so without the aid of a vaping device.

But instead of denying that this could possibly be happening, we need to open our eyes and see that this is one example where there is a confluence of public health goals and economic incentives for the vaping industry. Profits from the sale of vaping products increase as the sale of traditional cigarettes fall.

At some point, we need to figure out what our goal is. Is the goal to save lives and improve the public's health by decreasing the tremendous burden of smoking-related morbidity and mortality. Or is the goal simply to continue an unrelenting attack on the cigarette companies, which creates nice publicity for our organizations' membership and helps to attract larger donations?