Alaska Health Department Airs First Pro-Smoking Television Ad Since 1970

Since 1970, the television airwaves have been clear of pro-smoking advertisements. That is, until recently, when the Alaska Department of Health and Social Services began running a television spot that undoubtedly promotes smoking by strongly discouraging smokers who might otherwise quit from using electronic cigarettes. The commercial will likely also cause ex-smokers who have quit via electronic cigarettes to return to cigarette smoking. Worst of all, the commercial lies to the public by attributing to electronic cigarette diseases for which there is no evidence of an association with vaping.

The text of the commercial reads as follows:

"What's in an e-cig cloud? ... Nicotine, just like the other cigarettes. Ultrafine particles that can lead to asthma. Embalming fluid. Ugh. Lead. Doesn't that cause brain damage? Nail polish remover. ... Don't let Big Tobacco cloud your judgment."

The Alaska state health department also provides a fact sheet which implies that electronic cigarettes are no safer than real cigarettes. The health department justifies this conclusion based on a single study, which tested the effect of electronic cigarette vapor on bronchial cells in cell culture.

The Rest of the Story

There is no doubt that this commercial is extremely misleading and that it contains false information. It is designed to scare people so much about the health effects of vaping that they essentially view these products as no different from tobacco cigarettes in terms of health risk. The ultimate effect of this campaign is that many smokers in Alaska who might otherwise have quit smoking or cut down substantially by switching to electronic cigarettes will be dissuaded from doing so. Moreover, many ex-smokers who successfully quit via the use of electronic cigarettes may well return to smoking, since it appears from the commercial that e-cigarettes are not better for your health than tobacco cigarettes.

Let's start with the information that is outright false. The commercial implies that electronic cigarettes can cause "asthma" and "brain damage." This is an outright lie. There is absolutely no evidence that electronic cigarettes cause asthma or brain damage. In fact, Dr. Riccardo Polosa and colleagues have shown that electronic cigarettes actually improve symptoms of asthma in smokers who either completely or even partially switch to these products. No study has ever shown that electronic cigarettes cause brain damage. What we do know is that switching to electronic cigarettes can substantially improve the health of smokers.

Now let's move to the information that is downright misleading. Telling the public that electronic cigarettes contain embalming fluid and nail polish remover is misleading because it belies the fact that e-cigarettes merely contain small amounts of the main components of those products. Someone who uses an electronic cigarette is not inhaling embalming fluid any more than someone who purchases a new sofa is inhaling embalming fluid.

To demonstrate how misleading and damaging this commercial is, consider the very same commercial applied to nicotine gum:

"What's in nicotine gum? ... Nicotine, just like cigarettes. And 4-(methylnitro-samino)-1-(3-pyridyl)-1-butanone, a powerful carcinogen that causes lung cancer. N-Nitrosonornicotine. Doesn't that cause esophageal cancer? Don't let Big Pharma cloud your judgment."

The above commercial text is just as scientifically valid as that provided by the Alaska health department. However, if the Department aired such a commercial, it is very clear that such a campaign would be terribly misleading. It would also be terribly damaging, because it would likely scare people who might otherwise quit using nicotine gum not to proceed with their quit attempt. And it might dissuade people who have already quit using nicotine gum from continuing the gum use, which could likely lead to their returning to smoking.

If the tobacco industry put out such an advertisement, there is no question that we in public health would be condemning the campaign and arguing that it is a pro-smoking campaign. Anti-smoking groups would likely try to have the commercial pulled off television on the grounds that it is pro-smoking and thus violates the intent of the 1970 ban on television advertising of cigarettes.

Now consider the very same commercial applied to the nicotine inhaler:

"What's in a nicotine inhaler? ... Nicotine, just like cigarettes. Nickel, a metal which has been shown to cause cancer, respiratory failure, and heart disorders. Lead. Doesn't that cause brain damage? Don't let Big Pharma cloud your judgment."

Once again, the commercial text is just as scientifically valid as that provided by the Alaska health department. However, if the Department aired such a commercial, it is very clear that such a campaign would be terribly misleading. It would also be terribly damaging, because it would likely scare people who might otherwise quit using a nicotine inhaler not to proceed with their quit attempt. And it might dissuade people who have already quit using the nicotine inhaler from continuing the inhaler use, which could likely lead to their returning to smoking.

And once again, if the tobacco industry put out such an advertisement, there is no question that we in public health would be condemning the campaign and arguing that it is a pro-smoking campaign. Anti-smoking groups would likely try to have the commercial pulled off television on the grounds that it is pro-smoking and thus violates the intent of the 1970 ban on television advertising of cigarettes.

We could even run a similar commercial about the nicotine patch:

"What's in a nicotine patch? ... Nicotine, just like cigarettes. 4-(methylnitro-samino)-1-(3-pyridyl)-1-butanone, a powerful carcinogen that causes lung cancer. And doesn't that also cause lung immunosuppression? Don't let Big Pharma cloud your judgment."

Another untruthful aspect of the campaign is its denial that smoking is any more hazardous than vaping. Can you imagine if the tobacco industry made such a claim on a web site? The anti-smoking movement would be up in arms. How dare the tobacco industry undermine years of education about the hazards of cigarette smoking by telling the public that smoking may be no more hazardous than using an electronic cigarette. But this is exactly what the Alaska health department is doing.

My colleague Stan Glantz has praised the campaign, urging all other states to air the same commercial. However, I can't possibly condone a campaign that lies to the public, significantly misleads its audience, undermines years of public education about the health hazards of smoking, and has the effect of promoting smoking by discouraging smokers who would otherwise have quit using e-cigarettes not to do so. 

Latest UK Data Suggests Substantial Benefits of Electronic Cigarettes for Smoking Cessation

According to an article in The Guardian, electronic cigarettes were the fastest growing item in terms of supermarket sales in the UK in 2014: "E-cigarettes were the fastest-growing product in British supermarkets last year as consumers shrugged off the controversy over vaping. Sales of electronic cigarettes – or vapourisers – across the largest grocers rose 49.5% in 2014, despite clamour from health groups to ban the devices."

Data from the Smoking Toolkit Study (STS) show that there was a dramatic rise in the use of electronic cigarettes among adults in England that began in 2012 and continued through 2014. Contemporaneous data from the STS show that the period 2012-2014 marked a sudden reversal in the trend of declining annual smoking cessation rates.

From 2007-2011, annual quit rates declined steadily from 6.7% to 4.6%. But suddenly in 2012, things turned around. The quit rate jumped to 6.2%, remained at 6.1% in 2013, and rose further to 7.5% in 2014.

Moreover, the same trend was observed in the proportion of smokers trying to quit each year.

And to top it off, the same trend was observed in the proportion of smokers trying to quit who reported success in their quit attempt.

Of course, these is merely an ecological analysis. However, the pattern of these trends seems far too striking to be explained alternatively. The working hypothesis, it seems, should be that electronic cigarettes have played a major role in enhancing smoking cessation in the England, both by stimulating quit attempts and improving success in those quit attempts.

The Rest of the Story

The irony of this story is that policy makers in the UK wanted a virtual ban on electronic cigarettes, and health groups and many anti-smoking advocates in the U.S. favor policies that would put a huge dent in the growth of the electronic cigarette market (at the expense, of course, of increased tobacco cigarette sales).

This is probably the most profound example in my career of public health groups supporting policies that are antithetical to the overall goals of public health. Therefore, it warrants a careful examination of the reasons why anti-smoking groups are promoting such policies. Our search for these answers will continue at The Rest of the Story over the next few months.

The rest of the story is that the existing evidence suggests that electronic cigarettes are producing substantial public health benefits but causing very little in the way of public health harms. Based on the data available at the present time, I think it is safe to conclude that electronic cigarettes are having a very large net positive impact on the public's health. Unfortunately, anti-smoking groups are doing everything they can to negate this public health success story.

2014 Anti-Smoking Myth of the Year Award Goes to CDC, Dr. Stan Glantz, and Dr. Michael Fiore

The Rest of the Story is pleased to announce the recipients of the 2014 Anti-Smoking Myth of the Year Award. This year's award goes to:

• The Centers for Disease Control and Prevention (CDC);
• Dr. Stan Glantz; and
• Dr. Michael Fiore

for publicly spreading the myths that electronic cigarettes have been found to be a gateway to smoking among youth and that electronic cigarette experimentation leads to a lifelong addition to nicotine.

The CDC was first to the punch, with its director misrepresenting cross-sectional CDC survey data as conclusive evidence that electronic cigarettes are a gateway to smoking. Specifically, CDC Director Dr. Thomas Frieden stated:

"What we are doing first is tracking, and we are seeing some very concerning trends. Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes."

In addition, Dr. Frieden was quoted as stating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

The Office on Smoking and Health (where I used to work) vigorously supported these statements and failed to offer any public corrections. Nor am I aware of any other CDC corrections or retractions of these claims.

More recently, Dr. Stan Glantz began disseminating the conclusion that e-cigarettes are a gateway to smoking. In an article published in USA Today, he stated definitively that electronic cigarettes are a gateway to smoking. He was quoted as stating: "There's no question that e-cigarettes are a gateway to smoking."

And even more recently, Dr. Michael Fiore rang in the new year with a public statement that electronic cigarettes can lead youth to a lifetime addiction to nicotine. He was quoted as stating: "One of the biggest concerns about e-cigarettes is that they will serve as a gateway drug to lifelong nicotine dependence and all of the harms we know result from cigarette smoking. We know that the adolescent brain is very sensitive to nicotine. Use of e-cigarettes, with its exposure to nicotine, puts these adolescents at risk of lifelong nicotine addiction."

The Rest of the Story

As I have repeatedly pointed out, there is absolutely no existing evidence that electronic cigarettes are a gateway to smoking among youth or that electronic cigarette experimentation is leading youth to a lifetime of addiction to nicotine. In fact, the only evidence to date suggests that among U.S. youth, electronic cigarettes are not a gateway to smoking and e-cigarette experimentation does not appear to lead to regular (greater than weekly) use, much less to a lifetime of addiction.

President John F. Kennedy once said: "The great enemy of truth is not the lie--deliberate, contrived, and dishonest--but the myth--persistent, persuasive, and unrealistic." Here indeed, the repeated statements of the CDC and a number of prominent anti-smoking researchers have effectively created a myth, one that has become persistent and persuasive, even though it lacks evidence. And as a result, the media and in turn, policymakers, are accepting this myth as truth and making poor policy decisions because of it.

Interestingly, what President Kennedy went on to say in that 1962 speech relates perfectly to the manner in which the anti-smoking movement is dealing with the scientific question of whether e-cigarettes are a gateway to smoking.

Kennedy went on to say: "Too often we hold fast to the cliches of our forebears. We subject all facts to a prefabricated set of interpretations. We enjoy the comfort of opinion without the discomfort of thought."

This is precisely what is occurring in the tobacco control movement. We are holding fast to the cliches of the fast (i.e., the knowledge that smokeless tobacco can act as a gateway to cigarette use). We are subjecting all evidence to a prefabricated set of interpretations. Even cross-sectional evidence is being interpreted as showing that youth are starting with e-cigarettes and then progressing to active smoking. The CDC and some anti-smoking researchers are enjoying the comfort of expressing their conclusions about the gateway hypothesis without having to actually "think" (i.e., to actually analyze and interpret the scientific evidence that bears directly on this question).

I will close as President Kennedy did: "The stereotypes I have been discussing distract our attention and divide our effort. These stereotypes do our Nation a disservice, not just because they are exhausted and irrelevant, but above all because they are misleading--because they stand in the way of the solution of hard and complicated facts. It is not new that past debates should obscure present realities. But the damage of such a false dialogue is greater today than ever before... ."

Senator Durbin Asks Attorneys General to Violate the Constitution and Misinterpret the Master Settlement Agreement to Reign in Electronic Cigarettes

I am all for regulating the marketing of electronic cigarettes so that it does not target youth. However, I submit that measures to accomplish this should represent legitimate (i.e., constitutionally valid) government actions.

Last Friday, Senator Dick Durbin (D-IL) and Representatives Henry Waxman (D-CA) and Frank Pallone (D-NJ) sent a letter to all the state Attorneys General requesting that they define electronic cigarettes as "tobacco products" under the Master Settlement Agreement (MSA) and thereby, they claim, make e-cigarettes subject to the advertising restrictions that the MSA poses on tobacco manufacturers.

The letter states: "we believe you could take a significant step in the battle against tobacco use by classifying e-cigarettes as cigarettes under the Master Settlement Agreement (MSA) with the tobacco companies. ... we are writing to urge you to consider using your authority under the MSA to take immediate actions against the efforts of e-cigarette companies to target youth."

The letter also states: "We believe e-cigarettes meet all the criteria for the definition of cigarette (and tobacco product) in the Master Settlement Agreement. .. They contain "tobacco, ... in any form" because their key ingredient is nicotine, which is produced from tobacco leaves."

The Rest of the Story

Stan Glantz has praised this action of these politicians. I, on the other hand, condemn it.

Why? Because, very simply, it is unconstitutional. It clearly violates the rights of electronic cigarette companies. Specifically, it makes the electronic cigarette companies parties to a contract that they didn't sign. The government cannot do that. No one can do that. A contract is an agreement that is approved by the participating parties. A contract between these parties cannot tell other parties what they may or may not do. The Master Settlement Agreement was signed by the Attorneys General and several participating manufacturers (mainly, the large tobacco companies). It cannot set rules for other companies that were not parties to the agreement.

Moreover, these politicians are completely misinterpreting the Master Settlement Agreement. They misinterpret the MSA in two ways.

First, e-cigarettes are clearly not "cigarettes" as defined by the MSA. In order to be classified as a cigarette under the MSA, a product must contain tobacco. However, e-cigarettes do not contain tobacco. The politicians try to get around this by arguing that because they contain nicotine, they contain tobacco, as nicotine is derived from tobacco. But this argument flies in the face of basic rules of statutory construction. If the intent of the MSA was to define all nicotine-containing products as tobacco products, then it would not have been necessary to include the additional clause specifying that tobacco products must not only contain nicotine, but also contain tobacco.

Second, even if the Attorneys General redefine electronic cigarettes as tobacco products, that does not make the e-cigarette companies subject to the marketing restrictions in the MSA. The marketing restrictions only apply to "participating manufacturers." Because e-cigarette companies are obviously not "participating manufacturers," they cannot be subject to the MSA's marketing restrictions, regardless of how "tobacco products" are defined.

The rest of the story is that e-cigarette opponents like Stan Glantz and these politicians are so zealous about demonizing electronic cigarettes that they are willing to violate constitutional principles and basic legal rights of companies in order to achieve their aims.  

Canadian Survey Suggests that Electronic Cigarettes are a Useful Smoking Cessation Tool

A national public opinion survey of 2,154 adult Canadians taken by the Forum Poll found that among smokers who used electronic cigarettes primarily as a smoking cessation tool, 24% had quit smoking.

The study concluded that: "many vapers are trying to quit smoking tobacco, and between a quarter and a third are successful at this. So, it appears e-cigarettes don't represent the trojan horse they are painted as, and may be a very useful smoking cessation aid."

The Rest of the Story

It seems fortunate that a large number of smokers in Canada have ignored Health Canada's advice not to use electronic cigarettes. The health agency had advised smokers "not to purchase or use electronic smoking products, as these products may pose health risks and have not been fully evaluated for safety, quality and efficacy by Health Canada." Had all smokers taken Health Canada's advice, it appears that as many as one quarter of them who otherwise would have quit would instead still be smoking. It is ironic and unfortunate that a national health agency put out advice which runs contrary to the best interests of the public's health.

Due to differences in the legal status of e-cigarettes in the U.S. and Canada, these results cannot be extrapolated to the U.S. In Canada, the sale of nicotine-containing e-liquids was banned, although use by individuals is still legal. Therefore, it is possible that smokers in Canada who use electronic cigarettes are particularly motivated to quit smoking. This could, in part, explain the high observed smoking cessation rate in the survey.

I doubt that anti-smoking advocates and groups who oppose e-cigarettes will pay any heed to the results of this survey, as they appear not to be concerned with the actual scientific evidence, but instead, appear to have already drawn their conclusions. Nevertheless, if enough evidence accumulates to show that e-cigarettes are helping many smokers to quit, eventually it will be impossible for public policy makers to deny that e-cigarettes are a bona fide smoking cessation tool, despite the propaganda being disseminated by the anti-smoking groups.

Of note, the survey found that among those who are unsuccessful in quitting using e-cigarettes, about half have reduced the amount that they smoke. Thus, e-cigarettes may be benefiting those who fail to quit by reducing the damage done to the lungs and by decreasing the level of their addiction to smoking.

Also of note, 70% of smokers surveyed who had used e-cigarettes to try to quit reported that these products were somewhat or very effective in helping them quit. Despite the pre-determined conclusions of many anti-smoking groups, consumers seem to be indicating that these products can work.

Although penetration of e-cigarettes is not that high now, those using them are the young, and this behaviour is bound to become more popular. It appears, contrary to authorities' fears, that vaping is not a gateway to tobacco smoking, and many people who never smoked enjoy e-cigs for the flavours, not the nicotine. On the other hand, many vapers are trying to quit smoking tobacco, and between a quarter and a third are successful at this. So, it appears e-cigarettes don't represent the trojan horse they are painted as, and may be a very useful smoking cessation aid

Read more at: http://poll.forumresearch.com/post/197/two-thirds-using-e-cigs-to-quit-one-quarter-to-one-third-are-successful/
Copyright ©Forum Research Inc.

Although penetration of e-cigarettes is not that high now, those using them are the young, and this behaviour is bound to become more popular. It appears, contrary to authorities' fears, that vaping is not a gateway to tobacco smoking, and many people who never smoked enjoy e-cigs for the flavours, not the nicotine. On the other hand, many vapers are trying to quit smoking tobacco, and between a quarter and a third are successful at this. So, it appears e-cigarettes don't represent the trojan horse they are painted as, and may be a very useful smoking cessation aid

Read more at: http://poll.forumresearch.com/post/197/two-thirds-using-e-cigs-to-quit-one-quarter-to-one-third-are-successful/
Copyright ©Forum Research Inc.

Although penetration of e-cigarettes is not that high now, those using them are the young, and this behaviour is bound to become more popular. It appears, contrary to authorities' fears, that vaping is not a gateway to tobacco smoking, and many people who never smoked enjoy e-cigs for the flavours, not the nicotine. On the other hand, many vapers are trying to quit smoking tobacco, and between a quarter and a third are successful at this. So, it appears e-cigarettes don't represent the trojan horse they are painted as, and may be a very useful smoking cessation aid

Read more at: http://poll.forumresearch.com/post/197/two-thirds-using-e-cigs-to-quit-one-quarter-to-one-third-are-successful/
Copyright ©Forum Research Inc.

New Study Refutes Claim that Electronic Cigarettes are a Gateway to Smoking

A new study published in the American Journal of Preventive Medicine refutes the claim that electronic cigarettes are a gateway to smoking.

(See: Meier EM, Tackett AP, Miller MB, Grant DM, Wagener TL. Which nicotine products are gateways to regular use? First-tried tobacco and current use in college students. American Journal of Preventive Medicine 2015; 48(S1):S86-S93.)

The paper reports the results of an online survey of 1,304 undergraduate students at a large university in Oklahoma. The mean age of respondents was 19.6 years. Students were asked to report:

(1) the first nicotine-containing product they used (cigarettes, smokeless tobacco, electronic cigarettes, hookah, or NRT); and

(2) all of the nicotine-containing products that they current use.

Thus, the study was able to ascertain the proportion of students who had initiated nicotine use with electronic cigarettes and went on to become smokers (and remained smokers at the time of the survey).

The two most important findings of the study were as follows:

(1) Of the 1,304 students, only 3 reported having first tried electronic cigarettes and currently being a smoker. There were 59 students who had initiated with electronic cigarettes, so the proportion of these students who progressed to smoking and were currently smoking was 5.1%. In contrast, 18.6% of students who initiated nicotine use with smokeless tobacco progressed to smoking and were currently smoking.

(2) Of the 59 students who initiated nicotine use with e-cigarettes, only 1 was currently using e-cigarettes, and this student reported only occasional use of these products.

The authors conclude that: "ETPs were the first product tried by some students (n=59), 78% of whom first tried e-cigarettes. Interestingly, only one of these students was still using an ETP at the time of the study, and this was reported as occasional use of e-cigarettes. This may suggest that the uptake potential of current ETPs is limited among youth. This finding is supported by the fact that all dissolvable tobacco products have been taken off of the market by tobacco companies owing to poor uptake of these products.²⁹ Moreover, given the timing of data collection, it is likely that students who first tried e-cigarettes tried a first-generation device, which anecdotally is considered to be much less effective in delivering nicotine than newer models.³⁰ In addition, only one student who initiated with an ETP (1.7%) was a daily user of any tobacco product (i.e., conventional cigarettes), compared to the 10% and 21% of current daily tobacco users who first tried conventional cigarettes and SLT, respectively. Though this finding should be interpreted with caution, it potentially indicates that current ETPs are not necessarily strong gateways to regular tobacco use."

The Rest of the Story

This is the first study designed to actually answer the question of whether electronic cigarettes are a gateway to smoking because it is the first one to assess whether e-cigarette use preceded or followed cigarette use. It is inexplicable why some tobacco control advocates (Stan Glantz) and public health agencies (the CDC) had already concluded that e-cigarettes are a gateway to smoking in the absence of a single study that actually examined this question.

This study found only three students, in a sample of 1,300, who had initiated nicotine use with e-cigarettes and progressed to smoking. Moreover, only one of the students who initiated nicotine use with e-cigarettes was still using e-cigarettes, and only occasionally.

These findings refute the claim that electronic cigarettes are a gateway to smoking. Moreover, they suggest that the addictive potential of electronic cigarettes is quite low. The results support my contention that the public health consequences of e-cigarette experimentation among youth are not as dire as is being claimed by anti-smoking groups and health agencies. The current evidence does not support the conclusion that e-cigarette experimentation is a significant cause of nicotine addiction and subsequent uptake of smoking among youth.

There is one major caveat with this research. The sample consisted of college students and at the time many of them were in high school, e-cigarette use was not as popular. Also, most of these students probably initiated with first generation e-cigarette products, which do not deliver nicotine as effectively as more recently introduced products. Thus, to definitively answer the gateway question, we need a similar study among younger youth.

Despite this limitation, the rest of the story is that based on the current available evidence, there is no basis for concluding that e-cigarettes are a gateway to smoking. The CDC should immediately retract its claim that these products are a gateway to smoking to ensure that public policy is formulated based on science, rather than ideology.

Cochrane Review Concludes that Electronic Cigarettes Appear to Be Effective for Smoking Cessation and Reduction, Although Further Research is Necessary

The first Cochrane review of the effectiveness of electronic cigarettes has concluded that there is enough evidence to declare that these products are effective for smoking cessation and reduction.

(See: McRobbie H, Bullen C, Hartmann-Boyce J, Hajek P. Electronic cigarettes for smoking cessation and reduction. The Cochrane Library. Published online on December 17, 2014. DOI: 10.1002/14651858.CD010216.pub2.)

The authors describe their study inclusion criteria as follows: "We included randomized controlled trials (RCTs) in which current smokers (motivated or unmotivated to quit) were randomized to EC or a control condition, and which measured abstinence rates or changes in cigarette consumption at six months or longer. As the field of EC research is new, we also included cohort follow-up studies with at least six months follow-up. We included randomized cross-over trials and cohort follow-up studies that included at least one week of EC use for assessment of adverse events."

The results of the study were as follows: "Participants using an EC were more likely to have abstained from smoking for at least six months compared with participants using placebo EC (RR 2.29, 95% CI 1.05 to 4.96; placebo 4% versus EC 9%; 2 studies; GRADE: low). The one study that compared EC to nicotine patch found no significant difference in six-month abstinence rates, but the confidence intervals do not rule out a clinically important difference (RR 1.26, 95% CI: 0.68 to 2.34; GRADE: very low). A higher number of people were able to reduce cigarette consumption by at least half with ECs compared with placebo ECs (RR 1.31, 95% CI 1.02 to 1.68, 2 studies; placebo: 27% versus EC: 36%; GRADE: low) and compared with patch (RR 1.41, 95% CI 1.20 to 1.67, 1 study; patch: 44% versus EC: 61%; GRADE: very low). Unlike smoking cessation outcomes, reduction results were not biochemically verified. None of the RCTs or cohort studies reported any serious adverse events (SAEs) that were considered to be plausibly related to EC use."

The authors conclude: "There is evidence from two trials that ECs help smokers to stop smoking long-term compared with placebo ECs. However, the small number of trials, low event rates and wide confidence intervals around the estimates mean that our confidence in the result is rated 'low' by GRADE standards. The lack of difference between the effect of ECs compared with nicotine patches found in one trial is uncertain for similar reasons. ECs appear to help smokers unable to stop smoking altogether to reduce their cigarette consumption when compared with placebo ECs and nicotine patches, but the above limitations also affect certainty in this finding. In addition, lack of biochemical assessment of the actual reduction in smoke intake further limits this evidence. No evidence emerged that short-term EC use is associated with health risk."

The Rest of the Story

There is clearly a need for further research in this area, and the authors make it clear that they have low confidence in their conclusions because of the limited evidence. However, it does appear that at the current time, there is evidence that electronic cigarettes can be useful for smoking cessation and reduction and that they are probably at least as effective as other FDA-approved therapies. In addition, there is no evidence that these products cause any serious adverse side effects, at least in terms of short-term use.

These conclusions refute the statements being made by a number of tobacco control researchers and advocates that electronic cigarettes actually inhibit smoking cessation. And they also refute statements by some health agencies that there is no evidence that electronic cigarettes have any usefulness for smoking cessation.

There is an urgent need for a high-quality clinical trial of electronic cigarettes in the United States, especially since more conclusive information is necessary to inform the FDA as it prepares and implements regulations. I developed a protocol for such a study, but was unable to secure funding from electronic cigarette companies to conduct the study. Hopefully, someone will be able to secure funding. I am happy to share my protocol with any researchers who are interested in potentially conducting such a study.

IN MY VIEW: Why Hysteria Over Youth E-Cigarette Use is Overblown; And Why it May Not Normalize Smoking

In response to the release of the 2014 Monitoring the Future data, which show that more youth are experimenting with electronic cigarettes than smoking (in terms of past 30-day use), many anti-smoking groups have sounded the alarm. More specifically, these groups have told the public that these data demonstrate that e-cigarettes are normalizing smoking. As Sabrina Tavernese explains in her New York Times article: "Health advocates say the trend for e-cigarette use is dangerous because it is making smoking seem normal again." For example, the American Academy of Family Physicians argued that these data show that e-cigarette use is normalizing smoking.

I have already explained how anti-smoking groups are missing the most important finding from the Monitoring the Future study: that despite the dramatic increase in e-cigarette experimentation, youth smoking prevalence declined substantially and is at its lowest level in decades. This demonstrates that e-cigarettes are not a gateway to smoking, as has been claimed by the CDC and by some tobacco control advocates, led by Stan Glantz.

Thus, it turns out that the concern of anti-smoking groups that e-cigarettes will normalize smoking is misplaced. In fact, the evidence seems to suggest just the opposite. It may well be that e-cigarettes are de-normalizing smoking by actually diverting some youth who would otherwise have smoked to e-cigarettes, or by diverting some youth smokers to vaping. What e-cigarette use is normalizing is the use of electronic cigarettes, not the use of tobacco cigarettes. The anti-smoking groups fail to see this because they have drawn pre-determined conclusions based on their ideology, and they are not able to look objectively at the actual scientific evidence.

While the health groups got the story wrong, fortunately, Sabrina Tavernese got it right: "Health advocates say the trend for e-cigarette use is dangerous because it is making smoking seem normal again. They also worry it could lead to an increase in tobacco smoking, though the new data do not show that."

Today, I reveal another important finding of the recent surveys on electronic cigarette use that has been entirely ignored and which should lessen our concern about the public health implications of e-cigarette experimentation among youth.

The Rest of the Story

Another important finding of the recent surveys, which has been completely ignored, is the finding that despite the large number of youth who are experimenting with e-cigarettes, only a very small proportion are actually using these products regularly, in a way that could plausibly cause significant harm. Wills et al. found that although 29% of high school students had experimented with e-cigarettes, only 2% were using them more than once a week. This means that only 7% of all high school e-cigarette experimenters are vaping more than once a week, which should lessen concerns that these products are causing significant health harm.

The truth is that e-cigarettes pose little acute health harm. Almost all the potentially adverse health effects of e-cigarette use are related to long-term use (over a period of many years). The potential acute health effects are basically two-fold: (1) these products could potentially be a gateway to smoking; and (2) these products could addict kids to nicotine, causing prolonged use of e-cigarettes which could cause neurological damage.

As I discussed above, concern #1 does not appear to be a problem. And based on the Wills et al. data, it does not appear that #2 is currently a major problem either. The data suggests that despite the dramatic rise in e-cigarette experimentation, youth are not becoming addicted to these products. The pattern of e-cigarette use is almost entirely sporadic, with 93% of users vaping no more than once in an entire week. It is not clear that use of e-cigarettes at this level - only once a week - poses any significant health harms.

My point is that the public health significance of youth e-cigarette use may very well be positive, rather than negative. It is possible that these products have caused very little health harm, while at the same time, diverted many youth from smoking to vaping. We know that smoking experimentation quickly leads to addiction. But e-cigarette use does not appear to have the same level of addictiveness. Possibly because of the much lower and inconsistent nicotine delivery, these products do not appear to be creating e-cigarette addicts (among youth).

If it is true that e-cigarettes are diverting some youth away from smoking, then it is actually the case that e-cigarette use among youth is having a positive net effect on the public's health. Even if this is not the case, it appears that e-cigarette use among youth is having very little public health impact, thus meaning that the benefits of e-cigarettes for adults (smoking reduction and cessation) far outweigh the costs for youth.

Let me close by making one point very clear. I am not arguing that e-cigarette use among youth is not a concern, that youth e-cigarette use should be allowed or promoted, or that measures should not be taken to discourage e-cigarette use among youth. I support bans on the sale of e-cigarettes to minors, restrictions on advertising and marketing that is directed at youth, programs to educate youth about e-cigarettes, programs to discourage kids from using e-cigarettes, and most importantly, FDA regulations that require child-proof packaging on e-cigarettes and stronger warnings about the potential risks of nicotine (especially acute poisoning).

Nevertheless, it is critical that we get the science right. And as of today, the science suggests that: (1) e-cigarettes are not a gateway to smoking among youth; and (2) e-cigarettes may well be de-normalizing smoking rather than promoting it.

Glantz Tells Public There is No Question that E-Cigarettes are a Gateway to Smoking, But Today's Monitoring the Future Data Show the Opposite

In an article published yesterday in USA Today, Dr. Stanton Glantz states definitively that electronic cigarettes are a gateway to smoking. He was quoted as stating: "There's no question that e-cigarettes are a gateway to smoking."

The article highlights the findings of two new studies showing that rates of electronic cigarette use among youth continue to rise dramatically. According to the article: "About 25% of high school students in Connecticut and 29% of teens in Hawaii have used e-cigarettes, according to separate studies. About 18% of the Hawaii teens and 12% of the Connecticut high school students had used e-cigarettes in the past month. Both studies were done in 2013. Those rates are much higher than the latest data from the Centers for Disease Control and Prevention, which found 4.5% of high schoolers and 1.1% of middle schoolers had used e-cigarettes in the past 30 days in 2013. Authors of the Hawaii study, published online Monday in Pediatrics, note that e-cigarette use has grown exponentially among kids, doubling every year since 2009."

Today, the University of Michigan released data from the 2014 Monitoring the Future study which confirm that among a national sample of 8th, 10th, and 12th grade youth, rates of electronic cigarette use are between 9% and 17%. The prevalence of past 30-day use of electronic cigarettes was 8.7% among 8th graders, 16.2% among 10th graders, and 17.1% among 12th graders.

The Monitoring the Future study also found that the prevalence of cigarette smoking decreased substantially in all three groups. For 8th graders, the prevalence of past 30-day smoking dropped from 4.5% to 4.0%; for 10th graders, current smoking prevalence dropped from 9.1% to 7.2%, and among 12th graders, smoking prevalence dropped from 16.3% to 13.6%. In 2014, cigarette smoking was at its lowest level in decades.

The most dramatic declines in smoking occurred between 2011 and 2014. For 8th graders, smoking prevalence dropped from 6.1% to 4.0%; among 10th graders, smoking prevalence dropped from 11.8% to 7.2%; and among 12th graders, smoking prevalence dropped from 18.7% to 13.6%. However, the decline in smoking from 2013 to 2014 was by far the most substantial year-to-year decrease during this period.

The Rest of the Story

It is clear that experimentation with electronic cigarettes among youth has increased dramatically from 2011 to 2014. But despite this dramatic increase, the prevalence of current smoking among youth decreased dramatically. And the sharpest decline in smoking occurred concurrently with the largest increase in electronic cigarette use.

Dr. Glantz's conclusion - that electronic cigarettes are a gateway to smoking - just doesn't hold up in light of these data. If electronic cigarettes were serving as a major gateway to smoking, then we wouldn't expect to see such dramatic declines in smoking concurrent with dramatic increases in electronic cigarette experimentation. If anything, these national data suggest that electronic cigarettes may actually be serving as a deterrent to smoking by diverting kids who might otherwise try smoking over to a non-tobacco nicotine product. Even if it is the case that kids who might not have tried smoking are experimenting with e-cigarettes, this is very different from claiming that e-cigarettes are a gateway to smoking.

Furthermore, there simply are no studies to support the conclusion that e-cigarettes are a gateway to smoking. The only existing evidence suggests that e-cigarettes are not serving as a major gateway to smoking. Thus, Glantz has drawn a conclusion that is simply unsupported by any evidence.

Glantz now joins the CDC in disseminating the unsupported conclusion that e-cigarette experimentation is a gateway to smoking. One unfortunate consequence of public health agencies or researchers spreading this misinformation is that we risk losing our credibility, not just on the issue of electronic cigarettes, but on other issues as well. If we are not credible with respect to our opinions on electronic cigarettes, then why should the public trust us when we comment about tobacco cigarettes?

Sadly, this story simply adds to the long list of examples of the degradation in the rigor of science in the tobacco control movement.

CDC Makes Startling Proclamation: Electronic Cigarette Aerosol is Not as Safe as Clean Air

For the past two years, the Centers for Disease Control and Prevention (CDC) has been on a crusade to demonize electronic cigarettes. The agency has falsely claimed that its survey data demonstrate that electronic cigarettes are a gateway to cigarette smoking among youth. The agency has fabricated evidence that ex-smokers are in large numbers being driven back to smoking because of electronic cigarettes. The agency has scared the public by noting that rates of experimentation with electronic cigarettes doubled among youth, but failed to mention that almost all regular e-cigarette users were smokers or users of other forms of tobacco.

Now, the CDC is trying to dissuade the public from believing that vaping is safer than smoking. However, the worst thing the agency is able to say about the hazards of electronic cigarettes is that they are not as safe as "clean air."

In a December 12 MMWR article on electronic cigarettes, the CDC writes that some "contend that ENDS [electronic cigarettes] emit fewer toxins than combustible tobacco... . However, ENDS aerosol is not as safe as clean air."

The Rest of the Story

There are two striking things about these CDC statements.

First, it is extremely misleading to write that some groups "contend" that electronic cigarettes emit fewer toxins than combustible tobacco. By framing it in this way, the CDC is giving the impression that it does not agree with this contention, or at least, that the evidence is not clear.

However, there is abundant evidence that what these groups "contend" is the documented scientific truth. There is abudant evidence that electronic cigarettes emit fewer toxins than combustible tobacco, and no reputable scientist would argue otherwise. But by framing this as merely a contention, the CDC is insinuating that we don't actually know that electronic cigarettes emit fewer toxins.

Why would the CDC want to suggest to the public that we don't actually know that electronic cigarettes deliver fewer toxins that tobacco cigarettes? To me, this indicates a desire to demonize these products. Otherwise, why should the CDC be scared to tell the public the truth: that electronic cigarettes are much safer than tobacco cigarettes? And this isn't even going that far. It's merely acknowledging that e-cigarettes deliver fewer toxins than tobacco cigarettes.

Frankly, the CDC is using what we previously would have referred to as "tobacco speak." This is the way that the tobacco companies historically would frame their statements about the health effects of smoking. They would say things like: "Some public health officials contend that smoking causes ... ." Why is CDC now stooping to this level?

The second striking thing about the statement is that apparently, the worst thing the CDC can say about the adverse health effects of electronic cigarettes is that these products are not as safe as inhaling "clean air."

If that's the worst thing the CDC can say, then electronic cigarettes are apparently not that hazardous, or at least there is not currently any evidence to support the contention that they pose major hazards. Besides, you could say the same thing about any airborne exposure, including exposure to FDA-approved products. For example, you could correctly state that "aerosol from nicotine inhalers is not as safe as clean air."

Actually, it depends on how you define clean air. If you define it as simply being outdoor air, then it may not even be true that electronic cigarette aerosol is not as safe as "clean air." After all, in many urban areas, there are high levels of pollution in outdoor air. This air pollution has been associated with adverse cardiac and respiratory effects. So it is entirely possible that for some urban dwellers, their "clear air" is actually more hazardous than inhaling e-cigarette aerosol.

The rest of the story is that the CDC continues to misrepresent scientific evidence in order to demonize electronic cigarettes. If you didn't know any better, you might think that the agency has been paid by Big Tobacco to undermine the public's appreciation of the severe hazards associated with cigarette smoking and that it is trying to preserve, rather than decimate, the combustible tobacco market.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

First Meta-Analysis of Existing Studies Concludes that Electronic Cigarettes are Effective for Smoking Cessation

A meta-analysis of the existing studies which examined the effectiveness of electronic cigarettes for smoking cessation has concluded that these products are indeed effective. The study abstract, which was published on the Circulation website, was presented at an American Heart Association conference.

The study concluded as follows: "Six studies were selected, including two randomised controlled trials, two cohort studies and two cross-sectional studies, and included 7,551 participants. Meta-analyses included 1,242 participants on whom complete smoking cessation data was available. Of these, 224 (18%) reported smoking cessation after using nicotine-enriched e-cigarettes for a minimum period of six months. Use of such e-cigarettes was positively associated with smoking cessation with a pooled Effect Size of 0.20 (95% CI 0.11-0.28). Nicotine filled e-cigarettes were more effective in achieving cessation compared to those without nicotine (pooled Risk Ratio 2.29, 95% CI 1.05-4.97). Use of e-cigarettes was also effective in reducing smokers’ daily cigarette consumption."

The Rest of the Story

This meta-analysis reports, as its primary outcome variable, the proportion of smokers using e-cigarettes who quit successfully at six months (or longer). The authors found that 18% of all the smokers using e-cigarettes in the combined studies had quit after six months. This provides preliminary evidence that e-cigarettes do appear to be modestly effective for smoking cessation and that they certainly compare equally or favorably to existing FDA-approved drugs.

In contrast, a previously published meta-analysis of the effectiveness of FDA-approved smoking cessation drugs focuses on the pooled odds ratios. In fact, the study does not even report the absolute cessation rates. Thus, the fact that the study was funded by Pfizer unfortunately appears to be creating a bias in result reporting, as the authors are hiding the key piece of information that readers need to understand whether these drugs are really effective, or whether they are just better than placebo, which has a dismal cessation rate. (None of the authors of the e-cigarette meta-analysis reported any conflicts of interest.)

Remember that a drug can produce an odds ratio of 2, yet represent an 8% cessation rate compared to a 4% cessation rate. Moreover, in these clinical trials, the subjects who received placebo were likely to have known that their medication was inactive and may have suffered a huge initial disappointment which would have resulted in very dismal success rates.

Because this is just an abstract and has not yet been peer-reviewed, its results should be viewed as preliminary. Nevertheless, the conclusion of the study casts doubt on the many anti-smoking groups and advocates who continue to argue that there is no evidence that electronic cigarettes have efficacy in smoking cessation.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Required Reading: Michael Marlow's Commentary on the FDA's Proposed Deeming Regulations

Everyone involved in the debate over electronic cigarettes must read Dr. Michael Marlow's commentary on the FDA's proposed deeming regulations. According to his Mercatus Center biography, Dr. Marlow is "an affiliated senior scholar at the Mercatus Center at George Mason University and professor of economics and distinguished scholar at California Polytechnic State University, San Luis Obispo."

(See: Marlow ML. Regulating a less unhealthy cigarette: The FDA's treatment of e-cigarettes jeopardizes public health. Regulation. Fall 2014.)

In his commentary, Dr. Marlow argues that in its proposed deeming regulations, the FDA has completely skewed its cost-benefit analysis by failing to recognize the dramatic negative effect its burdensome regulatory requirements for electronic cigarettes will have on the public's health by virtue of the suppression of the e-cigarette market that these regulations will cause.

Dr. Marlow writes: "This article argues that the FDA jeopardizes public health by not developing an appropriate benefit-cost analysis of the proposed rule. The FDA “anticipates,” without quantifying, substantial benefits from reducing harm by regulating e-cigarettes and non-cigarette tobacco products. The FDA also does not adequately assess costs that appear likely from its suppression of the e-cigarette market. The evolving literature on e-cigarettes strongly suggests they help smokers to quit smoking. The proposed rule endangers public health by pushing e-cigarette manufacturers to focus efforts toward developing attributes unrelated to improved public health, thereby promoting combustible tobacco use and reducing the number of smokers who would use e-cigarettes to quit or reduce cigarette consumption. Public health would worsen because e-cigarettes are a safer alternative to tobacco cigarettes."

Dr. Marlow carefully articulates the adverse consequences to the public's health that would occur if the FDA's proposed deeming regulations are adopted. These regulations, he argues, would result in the suppression of the e-cigarette market, a stifling of product innovation, a contraction of the overall e-cigarette market with limitation of consumer choices and increased product costs, and an increase in youth e-cigarette use due to the prohibition of honest claims that e-cigarettes are safer than combustible tobacco products.

Dr. Marlow concludes that: "The FDA needs to develop a regulatory strategy that fully considers the potential benefits that smokers receive from e-cigarettes and the many unintended adverse effects on public health associated with how this proposed regulation slows the evolution of a promising harm reduction tool."

The Rest of the Story

This commentary very nicely summarizes many of the major points that I have tried to make here at the Rest of the Story over the past months. Like Dr. Marlow, I have argued that the proposed deeming regulations would suppress the e-cigarette market, stifle innovation, and contract the overall market by reducing the number of players as well as consumer choices. The burdensome requirement for a new product application for virtually every e-cigarette product on the market will almost certainly drive most e-cigarette companies and shops out of business. The net effect of this disruption of the industry will be a reduction in the rate at which smokers switch from combustible cigarettes to the much safer electronic ones. Thus, the net effect of the proposed regulations would be a strongly negative impact on public health.

In addition, Dr. Marlow nicely articulates the argument I have previously made that by disallowing companies from truthfully informing their customers that these products are safer than tobacco cigarettes and may be helpful in smoking cessation, the result will be that companies have no option other than marketing these products as having benefits unrelated to health, such as looking cool and sexy and allowing smokers to inhale nicotine in places where smoking is not allowed. The net effect of this suppression of the truth will be an increase in youth e-cigarette use, as honest marketing of e-cigarettes based on their health benefits would have far less appeal to youth.

Instead of the burdensome requirements that the FDA is proposing, I believe that the agency should take a different approach which recognizes the vast difference in risk between tobacco and electronic cigarettes, which embraces the harm reduction potential of e-cigarettes, and which enhances the progression of the nicotine market away from combustible products.

Specifically, the FDA should:

1. Scrap the requirement that e-cigarette products must submit new product applications.
2. Instead, simply promulgate uniform safety standards that all products must meet.
3. These standards should include:

• child-proof packaging;
• quality assurance of nicotine levels;
• battery and charging safety;
• voltage and/or temperature regulation to avoid the formation of carbonyl compounds like formaldehyde;
• manufacturing standards such as those set out by AEMSA;
• banning the use of diacetyl as a flavoring; and
• soldering restrictions to prevent the presence of metals in e-liquid.

       4. Explicitly allow companies to truthfully inform their customers that these products are intended to aid   in smoking cessation and that these products are much safer than tobacco cigarettes.

The last thing we need is the creation of a monstrous bureaucracy in which the FDA will have to review literally thousands of new product applications, including hundreds of applications - in some cases - from a single company. The FDA has not demonstrated how such a process, which is unduly burdensome, which actually benefit the public's health. Instead, the agency should simply mandate the safety standards that all companies must follow. This minimizes the bureuacracy, limits the economic and time burden on small companies, allows the market to continue to expand rather than contract, encourages innovation, and directly regulates the factors that will most affect product safety.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Anti-Smoking Groups Succeed in Undermining the Public's Appreciation of the Hazards of Smoking

New data reported by Clive Bates and presented in Joe Nocera's New York Times column about electronic cigarettes reveal that there has been a major change in the public's appreciation of the severe hazards of smoking in the past three years:

According to these sources, in 2010, 80% of the public believed that smoking was more hazardous than using non-tobacco-containing, non-combustible electronic cigarettes.

However, in 2013, only 60% of the public believed that smoking was more hazardous than using non-tobacco-containing, non-combustible electronic cigarettes.

This is bad news for public health, as it indicates that within three years, the public's appreciation of the severe hazards of smoking has been undermined. Twenty percent of the public has been convinced that smoking is no more hazardous than inhaling aerosol from a device which involves no combustion and contains no tobacco.

The Rest of the Story

Who is responsible for this undermining of the public's appreciation of the health hazards of smoking?

Historically, it was the tobacco industry which used public relations activities to undermine the public's appreciation of smoking's health hazards.

Sadly, it was not the tobacco industry which is responsible for today's bad news. Instead, I believe that it is clearly the result of a strong propaganda campaign by the anti-smoking groups.

For the past three years, the mainstream anti-smoking groups, as well as federal agencies including the FDA and the CDC, have been disseminating the message that electronic cigarette use is harmful and they have largely hidden from the public the fact that vaping is much safer than smoking. In addition, a number of anti-smoking groups and advocates have actually been spreading misinformation about the health hazards of vaping and the relative hazards of smoking compared to vaping.

As a result of these information campaigns, it is now clear that the public's appreciation of the health hazards of smoking has been undermined, as there has been a substantial decline in the proportion of the public which correctly believes that smoking is more hazardous than vaping.

This is not just a friendly debate about the potential role of electronic cigarettes as a tobacco control strategy. This is now a situation where the mainstream anti-smoking groups are actually doing tangible and demonstrable public health harm by completely distorting the relative risks of smoking compared to vaping and as a result, undermining the public's appreciation of the hazards of smoking.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

U.S. House Members Urge FDA to Change Grandfather Date in Proposed Deeming Regulations

Speaker of the House John Boehner, along with the House Majority Leader Kevin McCarthy and Chair of the Energy and Commerce Committee Fred Upton, have sent a letter to the FDA and Center for Tobacco Products urging that the proposed deeming regulations be changed. Specifically, they have requested that the FDA change the grandfather date of February 15, 2007 to either April 25, 2014 (the date the deeming regulation was published) or to the effective date of the final deeming regulation.

The representatives' concern is that with the proposed grandfather date, it will be virtually impossible for current electronic cigarette products to claim substantial equivalence to a predicate product. Therefore, virtually every electronic cigarette company will need to file a new product application, which is a burdensome and expensive undertaking. The net result could be the removal of thousands of electronic cigarette products from the market.

The letter asks the FDA to change the grandfather date "to ensure that these innovative products are not snuffed out by overly burdensome regulations."

According to the letter: "As a practical matter, many newly deemed products could be removed from the market. ... [T]he cost and barriers surrounding a new product submission would largely prevent new entries, posing an unwarranted regulatory barrier to innovation. ... This is a critical issue, and we request that manufacturers of newly deemed tobacco products have the same market entry opportunities as manufacturers of cigarettes and other currently regulated tobacco products. ... Any final provision on this issue should ensure equity among all regulated tobacco products and encourage innovation while achieving the purpose of the law."

The Rest of the Story

I agree with the request that is being made in this letter. However, I would go further and recommend that the FDA not require new product applications for any products. Doing so stifles innovation and makes it difficult if not impossible for newer products that may be safer and more effective to enter the market.

These comments are similar to those expressed by Altria Client Services, Lorillard, and the American E-Liquid Manufacturing Standards Association.

They also echo my initial comments about the proposed deeming regulations, when I wrote:

"The regulations require pre-approval (or substantial equivalence determinations) for all new electronic cigarette products."

"This provision is going to present a huge obstacle to innovation in this category. The newer products tend to be safer and more effective, so it makes no sense to allow the older products to remain on the market while requiring pre-approval for the newer and better products. The implications of this regulation is going to depend on the evidence that the agency requires to approve these applications. A stringent interpretation of the regulations will put a huge dent in electronic cigarette innovation and could limit the expansion of the market. In addition, this provision is going to place an undue burden on smaller companies and give a huge advantage to larger companies, including the tobacco companies that have entered the e-cigarette market."

"The regulations require pre-approval or substantial equivalence determinations of almost all existing electronic cigarette products."

"This provision is going to wreak havoc with the industry. The agency is determined that it cannot extend the grandfather date beyond 2007. This means that any product not on the market as of 2007 (which includes almost all electronic cigarette products) must either obtain a new product approval or a substantial equivalence determination. Given the snail's pace at which the FDA has processed cigarette substantial equivalence determinations, this could result in a literal quagmire of pending applications for the more than 250 brands of e-cigarettes currently on the market."

(Thanks to Greg Conley for the tip.)

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Boulder City Council Considering Legislation to Ban Vaping in Wide-Open Outdoor Areas

The Boulder (Colorado) City Council is considering legislation that would extend the city's smoking ban to include parks and open spaces and ban vaping in all the places where smoking is banned. Thus, the ordinance would ban vaping in all parks and open spaces. Specifically, vaping would be banned in the following outdoor areas:

• the downtown business improvement district;
• all parks and parkland;
• all open spaces and mountain parks property; and
• on any trail or multi-use path.

What is the city's justification for considering a ban on vaping in these wide-open outdoor areas? What is the evidence the city presents to justify such a draconian measure?

If you read the city's fact sheet on electronic cigarettes, you'll find out that the city does not name a single health problem that has been shown to be caused by exposure to "secondhand vapor." Instead, the worst thing that the city health department can say about secondhand vaping is this:

"ENDS [electronic cigarettes] aerosol has consistently been demonstrated to contain more than water."

The Rest of the Story

When the worst thing that can be said about the potential public health hazard of exposure to exhaled e-cigarette aerosol is that the aerosol has been shown to contain more than water, you know that you are dealing with a flimsy justification for this proposed policy.

This is truly a draconian policy. There is no scientific justification for banning smoking in wide-open outdoor spaces; there is absolutely no scientific justification for banning vaping in these places. It isn't even clear whether vaping indoors poses any significant hazards to the public. Certainly, vaping outdoors poses no substantial public health risks.

Beyond the lack of any public health justification for this vaping ban, the policy is flawed because it would likely discourage many smokers from quitting smoking via electronic cigarettes. It might even encourage some vapers to return to cigarette smoking. It is possible, then, that this policy could have negative net public health benefits.

Hopefully, the Boulder City Council will choose not to include vaping in this expanded smoking ordinance.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Proof of Concept Study Shows Great Promise for Second Generation Electronic Cigarettes

Riccardo Polosa and colleagues have just published a six month pilot study, in which 50 smokers who were not interested in quitting were provided with a second generation electronic cigarette (personal vaporizer). The specific product was the EGO/CE4 model. Participants were also provided with chargers and e-liquids throughout the study period.

At six months, a sustained 50% or greater reduction in cigarette consumption was observed in 15 subjects (30%), with mean consumption dropping from 25 cigarettes per day to 6 cigarettes per day. Of these 15 subjects, 7 (14% of the total sample) experienced a sustained reduction of 80% or more in their cigarette consumption, with their mean consumption dropping to just 3 cigarettes per day.

Also at six months, smoking abstinence was reported by 18 subjects (36% of the sample).

Therefore, in total, 33 subjects, or 66%, were either able to quit smoking or cut down on the amount they smoke by at least 50%.

The Rest of the Story

This is a small pilot study and there is no control group or randomization of subjects, so it must be interpreted cautiously. Nevertheless, considering that these were smokers who expressed no interest in quitting, the finding that two-thirds either quit or cut down by more than 50% is encouraging.

This study also demonstrates some of the complexities of studying the effectiveness of electronic cigarettes. There are a wide range of products on the market with different abilities to effectively deliver nicotine and to produce a full vapor that delivers a sufficient throat hit to satisfy many smokers. It may be that the effectiveness of these products could improve over time, as inefficient products are replaced with ones that are better able to satisfy the needs of smokers.

This is why the FDA's proposed deeming regulations make no sense. They would prohibit the introduction of new products into the market, keeping the older and antiquated products going and stifling innovation. The process to get a new product approved is complex and involves showing that the product is beneficial to the public's health. I interpret this as meaning that a new product would have to conduct a clinical trial that shows the effectiveness of the particular product whose approval is being sought. This barrier is a huge one.

This would be unfortunate because the quality and effectiveness of electronic cigarettes appear to be increasing over time. Why would the FDA want to stifle innovation and essentially force the market to be stuck with the less effective products? This is not a recipe designed to maximize the number of smokers who successfully quit smoking. If anything, it is a recipe designed to protect traditional cigarette sales.

Hopefully, the FDA will reconsider this provision of the deeming regulations and will remove it from the final regulation. Innovation in this industry should be encouraged and promoted, not stifled.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

New CDC Study Reveals that Youth Smoking has Declined Despite Tripling of Electronic Cigarette Use Among High Schoolers

A new study released today by the CDC reports that although electronic cigarette use has doubled among middle-school students and tripled among high school students, there was a marked reduction in cigarette smoking in both groups from 2011/12 to 2013.

During this time period, current e-cigarette use among middle-school students increased from 0.6% to 1.1%. At the same time, current cigarette smoking declined from 4.3% to 2.9%.

Among high school students, current e-cigarette use increased from 1.5% to 4.5%. Concurrently, current cigarette smoking dropped from 15.8% to 12.7%.

The study also reported that there were very few never smokers who were currently using electronic cigarettes.

The Rest of the Story

The finding that despite a tripling of current e-cigarette use among high school students, the smoking prevalence among this group dropped substantially suggests that electronic cigarettes are not serving as a major gateway to cigarette smoking among youth.

Although the CDC has been disseminating to the public its contention that electronic cigarettes are a gateway to youth smoking, it has yet to produce a shred of evidence that this is the case. In fact, it has not identified a single youth who started with electronic cigarettes and then progressed to cigarette smoking.

Nevertheless, the CDC director stated last year that: "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes."

Given the absence of evidence that e-cigarette use is a gateway to smoking and the lack of any documentation that kids are starting out with e-cigarettes and then progressing to cigarette smoking, it seems that the CDC should correct its earlier statement and apologize for letting it sit out there in the media for more than a year.

It is doing damage because policy makers are accepting this unsupported statement as the truth, and are using it as the basis for stringent regulations of electronic cigarettes which may end up causing more public health harm than good. The benefits of electronic cigarettes in terms of helping smokers to quit or cut down needs to be weighed against the harms in terms of potentially recruiting new smokers or e-cigarette addicts. However, so far there is no evidence that either of these phenomena are occurring.

Certainly, we need to continue to carefully monitor the situation and to conduct research to clearly identify the trajectory and time course of electronic cigarette and tobacco cigarette use among youth. But as a start, we need our public health agencies to be honest with us about the facts. Distorting the science to create more compelling stories or to fulfill predetermined conclusions is not appropriate.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

New State Study Shows Dramatic Reduction in Youth Smoking Despite Sharp Rise in E-Cigarette Use

New data out of Minnesota shows that despite a marked increase in e-cigarette use among Minnesota teenagers, there was a corresponding dramatic decline in tobacco cigarette smoking.

According to the report: "The 2014 Minnesota Youth Tobacco Survey found that the percent of high school students who smoked cigarettes in the past 30 days dropped from 18.1 percent in 2011 to 10.6 percent in 2014."

At the same time: "12.9 percent of high school students used or tried an electronic cigarette in the past 30 days. The survey found that 28 percent of high school students reported ever having tried an e-cigarette."

The Rest of the Story

These findings add further evidence that electronic cigarettes are not currently serving as any kind of major gateway to cigarette smoking. Despite massive levels of experimentation with electronic cigarettes, youth smoking rates are falling dramatically. This pretty much rules out the hypothesis that e-cigarettes are a major gateway to smoking.

Stan Glantz has reviewed additional evidence which documents rather dramatic increases in electronic cigarette use in the past few years, some of which is occurring among nonsmokers. However, these data actually add to the evidence that e-cigarettes are not a major gateway to smoking because they demonstrate that this experimentation, even among nonsmokers, is occurring at a time when smoking rates among youth have fallen to historic low levels.

Bottom line: There is no evidence at the current time that electronic cigarettes are serving as a gateway to smoking among youth.

Unfortunately, the lack of evidence did not stop the CDC director from proclaiming publicly that e-cigarettes are a gateway to youth smoking. And sadly, I am not aware that the director has made any sort of retraction, correction, or apology.

Meanwhile, the bogus conclusion that youth electronic cigarette use is a major risk for increased youth smoking continues to deceive policy makers throughout the country and risks the formation of inappropriate and unsupported state and federal policies regarding electronic cigarettes.

Despite all the attention to the hypothetical risks of electronic cigarettes, which so far have not been shown to pose any substantial risk to young people, the policy makers remain silent about menthol cigarettes, which - according to the Minnesota report - are currently smoked by 44% of youth smokers. This is not a hypothetical risk. This is not a slight chance of progression to smoking. These are kids who are already smoking and most likely already addicted to smoking. And half of these kids who continue to smoke over a lifetime will die prematurely of this addiction.

But nobody in the anti-smoking movement seems to care. It appears that we just can't stand hypothetical or unknown risks. But known epidemics of disease and death are just fine.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

New Study Suggests that Menthol Cigarettes May Be Worse for Lung Health; Policy Makers Respond by Calling for Ban on Flavored Electronic Cigarettes

I'm not much kidding in making that connection. If there is any flavor in tobacco products that is contributing toward youth addiction and ultimately, disease, it is menthol. Menthol cigarettes are preferred by nearly 50% of youth smokers. And menthol is the one flavoring that was exempt from prohibition under the Family Smoking Prevention and Tobacco Control Act.

Who was responsible for that exemption? Ironically, the policy makers who are currently calling for a ban on flavorings in electronic cigarettes.

Despite the lack of evidence that electronic cigarettes are leading to any tobacco use among youth, and despite the strength of the evidence that menthol cigarettes make up about 50% of the tobacco cigarettes that youth do smoke, it makes absolutely no sense for policy makers to call for a ban on flavorings in electronic cigarettes, but not to demand a similar policy for the menthol in cigarettes.

Unfortunately, this is exactly the state of affairs among the leading politicians who supported the Family Smoking Prevention and Tobacco Control Act and who are now switching their attention over to electronic cigarettes, which they are treating like a far greater scourge on the health of our nation's children.

The new study found that menthol smokers had higher rates of hospitalization for chronic lung disease. Beware, however. There were major differences between the populations of menthol and non-menthol smokers in this study, and I do not personally feel that the study controlled adequately enough for these differences to be able to attribute the observed health differences specifically to the presence of menthol.

Similarly, I have long argued that a policy which aims to ban menthol because menthol cigarettes pose a greater health risk than non-menthol cigarettes is flawed from the start, because the scientific evidence doesn't support such a judgment.

In fact, the reason for the flavorings ban in the Tobacco Control Act is not that flavored cigarettes are any more hazardous, but that - hypothetically - youth would be more attracted to such products. But on that basis, not only should menthol cigarettes have been banned, but all flavorings that are added to cigarettes should have been banned as well. In other words, the policy made little sense and was internally and externally inconsistent from day one.

Now is the time for the politicians to put up or shut up. Either back up your supposed concern for kids' health by sponsoring legislation to ban menthol and all flavorings in cigarettes, or cut the crap about the need to ban the flavorings from e-cigarettes in order to end the scourge that these flavors are having on our nation's children.

Anti-Smoking Groups and Politicians are Way Off the Mark in Accusing Altria and Reynolds American of Targeting Children with their E-Cigarettes

In recent months, a host of anti-smoking groups as well as several leading politicians in Congress and at the state level have attacked the Big Tobacco companies - including Reynolds American and Altria - for targeting their electronic cigarette products to children.

While it may sound like a great sound bite, it fits the mantra of tobacco control, and it may be consistent with historical practices of these tobacco companies in marketing cigarettes to youth, there is much more here than meets the eye. As much as the anti-smoking groups might like, things are not that simple.

Specifically, this claim by anti-smoking groups and politicians is demonstrably false. And by continuing to make this false accusation, it detracts from the anti-smoking groups' legitimate complaints against a small number of e-cigarette companies that do appear to be crossing the line.

The Rest of the Story

In their complaints, the anti-smoking groups and politicians have specified the ways in which e-cigarette companies are targeting kids. First, according to these groups, the use of candy and fruit-flavored products is a sure sign of youth targeting. Second, selling their products over the internet is an attempt to recruit youth customers, since it is much easier for underage customers to purchase over the internet than to purchase in face-to-face sales in brick-and-mortar facilities. Third, electronic cigarette companies are targeting kids by offering disposable products at cheap prices.

Let's now examine Reynolds American's e-cigarette product (Vuse) and Altria's product (Nu Mark) to see how they fare on each of these youth targeting criteria:

VUSE
Candy and fruit flavors: None. Only tobacco and menthol.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

NU MARK
Candy and fruit flavors: None. Only tobacco and menthol.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

Not only is there a lack of evidence that Vuse and Nu Mark are not targeting youth, but there is very strong evidence that these products are not targeting youth. 

Nevertheless, I am not aware of any mainstream tobacco control group which has so much as acknowledged that Vuse and Nu Mark are indeed being responsibly marketed toward adult smokers. 

My readers know that I can certainly dish out criticism when it is warranted. But at the same time, I feel it is important to be discriminating, and to withhold criticism unless it is warranted and backed up by adequate evidence. 

Unfortunately, the anti-smoking groups and politicians seems incapable of such discrimination. Everything is black and white, and there is no need to actually examine the scientific evidence. 

Except that the rest of the story is that for Vuse and Nu Mark, it isn't black and white. It's exclusively classic tobacco and menthol.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Study Suggests that Telling Smokers the Truth About Electronic Cigarettes Could Enhance Smoking Cessation

Last week, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research, which reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation. The study found that intensive electronic cigarettes users at baseline were six times more likely to quit smoking after a two-year follow-up period compared to intermittent or non-users.

One additional important finding of this study deserves mention.

The study found a difference in the reasons for starting e-cigarette use between triers (those who only vaped one or two times), intermittent users, and intensive users (those who vaped daily for at least one month).

Among the intensive users, the overwhelming majority (87.6%) reported that they were vaping because of health concerns: they were concerned about their own health and/or wanted to quit smoking or cut down on the amount that they smoked.

Among the intermittent users, this percentage was only 53.6%, and among the triers, it was only 55.2%. Other major reasons given among the triers and intermittent users were vaping where smoking is not allowed and avoiding exposing others to tobacco smoke.

Overall, then, the most intensive users -- who were also more likely to quit successfully -- tended to be smokers who were using electronic cigarettes specifically with a health purpose in mind (usually, quitting smoking). There were fewer "ancillary" reasons for use among these intense users.

As the authors concluded: "those who did not progress to extended daily use of e-cigarettes were using them for reasons other than the desire to quit smoking."

The Rest of the Story

This highlights one of the major problems with the proposed regulation of e-cigarettes, as well as the way many anti-smoking groups are treating these products.

First, in terms of proposed regulation, the FDA's proposed deeming regulations would prohibit companies from telling the truth about their products. Companies could not point out that electronic cigarettes produce no smoke, nor could they truthfully make the point that these products are much safer than cigarettes. Beware of making a therapeutic claim, they could not point out that the primary purpose of these products is for smoking cessation. In short, the proposed regulations would prohibit companies from marketing these products truthfully: the companies would have to pretend that improving health has nothing to do with why these products exist or why one would want to use an e-cigarette instead of a real one.

This is absurd, and it needs to be changed in the final regulations. First, companies should be explicitly allowed to point out that these products contain no tobacco smoke. Second, companies should be allowed to truthfully inform consumers that vaping is much safer than smoking. Third, companies should be allowed to make a certain set of claims regarding smoking cessation. They should not be allowed to market these products as nicotine delivery devices or with the purpose of treating nicotine dependence or addiction (since these are diseases/conditions). But instead, they should be allowed to truthfully note that the primary intention of these products is to get smokers off of cigarettes. They should also be allowed to inform consumers that many smokers have successfully quit smoking using e-cigarettes. The FDA should allow this subset of claims to be made without running afoul of the Food, Drug, and Cosmetic Act (i.e., without having to reclassify their products as drugs and therefore pull them off the market while submitting a new drug application).

Second, in terms of the statements of anti-smoking groups, they should stop criticizing electronic cigarette companies for making truthful claims, such as that these products have helped many people quit smoking or that these products are much safer than tobacco cigarettes. By discouraging these types of truthful claims, the anti-smoking groups have in fact backed the e-cigarette companies into a corner: all they can do without arousing the ire of the anti-smoking groups is to market e-cigarettes as a glamorous or sexy form of tobacco use, or as a product that can be used where smoking is not allowed. This is exactly how we don't want these products to be marketed.

The rest of the story is that it isn't as simple as condemning electronic cigarette companies for using marketing that seems to appeal to young people, or which casts vaping as being glamorous or sexy. The companies have been boxed into a corner. And the ones boxing them into that corner are us! By us, I mean public health groups and agencies.

It is time to not only allow, but to encourage the truthful marketing of electronic cigarettes. Based on the current research, such an approach would actually aid the public's health by encouraging more serious vapers who would have a higher likelihood of making the complete switch from tobacco cigarettes to the much safer electronic ones.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Unlike Data from U.S., Data on Youth Electronic Cigarette Use in Poland is Concerning

A new set of cross-sectional surveys of e-cigarette use among Polish students ages 15-19 was just published in the Journal of Adolescent Health.

(See: Goniewicz ML, et al. Rise in electronic cigarette use among adolescents in Poland. Journal of Adolescent Health 2014; 55:713-715.)

Like its U.S. counterpart (the National Youth Tobacco Survey), the survey from Poland found a dramatic increase in experimentation with electronic cigarettes during the period 2010/11 - 2013/14. Experimentation increased from 16.8% to 62.1%.

Different from the U.S. study, however, the Poland study found very high rates of current use of electronic cigarettes, which rose from 5.5% to 29.9%.

Most alarming, and completely different from results observed in the U.S., the prevalence of cigarette smoking during the study period increased substantially, rising from 23.9% to 38.0%.

The Rest of the Story

In and of itself, the increase in electronic cigarette experimentation in Poland is to be expected. However, there are two aspects of the data which are alarming.

First, not only did experimentation rise, but the rates of current use of electronic cigarettes are substantially higher than they are in the U.S. This suggests that not only are Polish youth trying these products, but the products seem to have more of a "stick" factor than they do in the U.S.

Second, and more alarming, is the finding that the dramatic increase in electronic cigarette use is occurring in the presence of a substantial increase in cigarette smoking. This is completely unlike the situation in the U.S., where the dramatic rise in experimentation with electronic cigarettes has been associated with a decline in youth smoking to its lowest level in recent history.

As the authors point, out the combination of the dramatic increase in e-cigarette experimentation, the high prevalence of current e-cigarette use, and both in the setting of a substantial increase in smoking prevalence do not appear to be consistent with the hypothesis that the use of electronic cigarettes among youth in Poland is displacing tobacco cigarettes.

Of course, this is only a cross-sectional study so it is premature to conclude that it is the electronic cigarette use that caused the observed increase in smoking. There are many other factors which could be at play. Nevertheless, these are the type of data which would cause me concern should they appear in U.S. surveys.

There are three major takeaways from this story.

First, having seen what concerning data about e-cigarette and cigarette use among youth would look like, this should be reassuring to public health advocates in the United States, where the data look very different and do not support the conclusion that e-cigarettes are serving as any sort of gateway to cigarette smoking.

Second, it may be that country-specific policies are necessary to regulate e-cigarettes, as the products being used and the use and popularity of the products may differ from country to country. A one size fits all approach may not make sense for such a complex phenomenon with an incredible diversity of types of products.

Third, comparing how different anti-smoking groups present the results of these findings along with those of the U.S. findings should be instructive in terms of identifying potential biases.

Those who report both the U.S. findings and Poland findings as demonstrating the gateway effect of youth moving from e-cigarettes to smoking (i.e., Glantz, Dutra, etc.) are clearly biased towards presenting the negative effects of e-cigarettes, rather than the truth.

Those who report both the U.S. findings and Poland findings as great news that should spare us concerns about the use of electronic cigarettes among youth are clearly biased towards electronic cigarettes and downplaying potential risks.

Those who report the U.S. findings and Poland findings differently (with the Poland findings showing reason for concern and the U.S. findings not ringing alarm bells about any significant gateway effects) are probably presenting a much more balanced and nuanced (and less biased) picture of the scientific data.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.