New CDC Data Suggest that Electronic Cigarettes are Strongly Associated with Quit Attempts

New CDC data released today on adult use of electronic cigarettes in 2014 suggest that vaping is strongly associated with quit attempts. Three of the main findings were:

1. "Current cigarette smokers who had tried to quit smoking in the past year were more likely than smokers who had not tried to quit to have ever tried an e-cigarette."

2. "Current cigarette smokers who had tried to quit in the past year (20.3%) were almost twice as likely as cigarette smokers who had not tried to quit (11.8%) to currently use e-cigarettes."

3. "Nearly one in four recent former cigarette smokers (22.0%) currently used e-cigarettes."

The Rest of the Story

These data suggest that electronic cigarettes are strongly associated with smokers making quit attempts. If you want to know whether a smoker has tried to quit smoking recently, ask him if he is using e-cigarettes and you'll have a good indication.

Moreover, since 22% of recent former smokers are current e-cigarette users, it appears that electronic cigarettes have played a major role in smoking cessation for nearly one-fourth of this population of recent quitters.

These population-based data are informative, as they provide one of the first investigations into the potential benefits of electronic cigarettes. And the initial indications are that electronic cigarettes are playing a substantial role in smoking cessation attempts and in actual quitting.

Coming Soon: Analysis of FDA Deeming Regulations for Electronic Cigarettes and Vaping Devices

The Tobacco Vapor Electronic Cigarette Association is releasing a copy of the FDA e-cigarette deeming regulations in sections (it is more than 600 pages). As soon as I digest the document, I will provide an analysis and commentary.

New Study Finds that Reducing Youth Access to E-Cigarettes May Increase Youth Smoking

A new study published online ahead of print in the Journal of Health Economics finds that state laws which reduce youth access to e-cigarettes by banning the sale of these products to minors were associated with higher youth smoking rates compared to states without these bans.

(See: Friedman AS. How does electronic cigarette access affect adolescent smoking? Journal of Health Economics. Published online on October 19, 2015. doi:10.1016/j.jhealeco.2015.10.003.)

The paper reports the results of an econometric analysis of trends in biennial rates of youth cigarette smoking from 2002-2013, comparing trends in states with an electronic cigarette sales ban to minors in effect as of January 1, 2013 to trends in states without such a ban. The analysis controls for each state's cigarette taxes, smoke-free air laws, and secular changes in youth smoking.

The paper finds the following: "This paper examines the causal impact of e-cigarette access on conventional cigarette use by adolescents. Regression analyses consider how state bans on e-cigarette sales to minors influence smoking rates among 12 to 17 year olds. Such bans yield a statistically significant 0.9 percentage point increase in recent smoking in this age group, relative to states without such bans. Results are robust to multiple specifications as well as several falsification and placebo checks. This effect is both consistent with e-cigarette access reducing smoking among minors, and large: banning electronic cigarette sales to minors counteracts 70 percent of the downward pre-trend in teen cigarette smoking in the states that implemented such bans."

The authors conclude that: "Across the board, this paper's analyses find that reducing e-cigarette access increases smoking among 12 to 17 year olds. .. banning e-cigarette access increased teen smoking rates."

The Rest of the Story

The chief limitation of this study is that it did not directly measure youth access to electronic cigarettes, nor did it measure actual rates of e-cigarette use to confirm that access was reduced in states with sales bans to minors. Thus, it is not clear whether this variable actually measures reduced access to and use of e-cigarettes or whether it represents some other factor that is related both to the nature of states that implemented a sales ban and to youth smoking.

However, it is not clear why states that enacted a sales ban would have characteristics making it more likely to see a reduced rate of decline in youth smoking in those states. In fact, baseline smoking rates were lower in the states which enacted an e-cigarette sales ban. According to anti-smoking advocates, the tremendous success of these states in reducing youth access is being undermined by youth e-cigarette use. The results of this study do not seem consistent with such a hypothesis. On the contrary, the results suggest that e-cigarette availability might actually be diverting some youths away from smoking.

It is of course necessary to wait until further research is conducted before drawing the conclusion that e-cigarette access reduces youth smoking. Much needed is a study that actually measures e-cigarette use among youth and compares smoking rates between populations with high and low use.

It is, however, quite plausible that e-cigarette use could reduce smoking rates. Insofar as electronic cigarettes represent a more attractive alternative to tobacco cigarettes, they may actually draw youth away from smoking and towards vaping. In particular, the attractive flavors available with e-cigarettes may be much more appealing than the harsh taste of real cigarettes. And it is difficult to imagine a youth wanting to smoke real cigarettes after getting used to a sweetly flavored e-cigarette. Furthermore, e-cigarettes could serve as an alternative for youth smokers who are looking to quit.

Even if it is true that e-cigarette use reduces youth smoking, I would not advocate promoting e-cigarette use among youth or easing the availability of these products to minors. However, I do think that such evidence would be important in assessing the balance of the risks and benefits of promoting e-cigarettes to adult smokers.

Democratic Senators Urge OMB to Decimate Electronic Cigarette Industry

In a letter sent last Wednesday to the Office on Management and Budget (OMB), 11 Democratic senators, led by Jeff Merkley (OR) and Richard Blumenthal (CT), urged the agency to expedite its review of the FDA's electronic cigarette deeming regulations and not to change the proposed grandfather date of February 15, 2007.

In the letter, Senators Markley, Blumenthal, and colleagues wrote: "We urge OMB to work quickly to finalize review of the final deeming rule, ensuring that the rule gives FDA authority over all tobacco products including e-cigarettes and cigars, explicitly bans the use of flavorings and marketing that appeals to children, and mandates child-proof packaging of e-liquids (liquid nicotine). We also implore that the final rule not move the “grandfather date” for new products (set at February 15, 2007). Altering this grandfather date would exempt a wide range of e-cigarettes and related products from any premarket review to determine whether they constitute threats to public health."

Other senators co-signing the letter were: Charles E. Schumer (D-NY), Patty Murray (D-WA), Barbara Boxer (D-CA), Edward J. Markey (D-MA), Sherrod Brown (D-OH), Dick Durbin (D-IL), Jack Reed (D-RI), Dianne Feinstein (D-CA), and Elizabeth Warren (D-MA).

The Rest of the Story

Far from protecting the public's health, establishing a grandfather date of February 15, 2007 would lead to the decimation of the electronic cigarette industry, forcing thousands of vapers back to tobacco cigarettes and preventing successful cessation among thousands of others, thus wreaking a terrible toll on the public in terms of disease and death.

Why? Because with a grandfather date in 2007, every electronic cigarette on the market will have to file a new tobacco product application with the FDA. New product applications require that the company demonstrate that the product is appropriate for the public's health. This means not only that the product must be shown to be safer than cigarettes for smokers who switch to the product, but also that the product benefits the public's health, taking into account nonusers of the product. Thus, in order to meet FDA approval, you would have to prove that the product improves health, both on an individual and a population level.

While I believe it would be quite straightforward to demonstrate the individual health benefits of electronic cigarettes over real ones, it is not so trivial to have to demonstrate the overall population-level benefits. To do this, one would have to estimate the proportion of smokers who would switch to electronic cigarettes and the proportion of nonsmokers who would start using the product. One would also have to know the percentage of nonsmokers who would progress to smoking. And finally, one would need to know the natural course of changes in smoking behavior over time when a cohort of smokers tries electronic cigarettes.

The studies required to obtain this information are substantial, and it is doubtful that most smaller companies have the resources to conduct these studies. It is not initially clear to me that any company would be able to meet this regulatory burden. However, if any companies are equipped to do so, it is the tobacco companies and perhaps the largest of the electronic cigarette companies.

The end result of this provision would likely be to contract the market, making fewer choices available to consumers.

But taking a step back, what sense does it make to require new product applications in the first place?

With cigarettes, I can see how new product applications make sense. The tobacco companies had a history of introducing products to the market that appeared safer, but were not. They also had a history of making product changes in order to make cigarettes more addictive. Therefore, it might make some sense to require new product applications for cigarettes.

However, for electronic cigarettes, it makes absolutely no sense. To be sure, the newer products are the safest and the most effective. It is the older products - the antiquated ones - that were much less effective and generally not as safe. With time, product quality has improved, more manufacturing standards have been put in place, better methods have been developed, and safer products have been produced.

Moreover, requiring new product applications for electronic cigarettes would greatly inhibit innovation and constrict the e-cigarette market, reducing the beneficial impact of electronic cigarettes in reducing combustible cigarette consumption.

The rest of the story is that this group of senators has it all wrong. They are doing the exact opposite of what they should be doing. Instead of urging that there be a requirement for new product applications for all the new and improved electronic cigarettes to stay on the market or to enter the market, these senators should be urging OMB to make sure that the FDA sets uniform safety standards for all electronic cigarettes. This would protect the public's health while allowing consumers to continue quitting smoking or cutting down substantially with a host of electronic cigarette brands and vaping products. 

The truth is that what these senators are demanding will harm the public's health rather than protect it. Or stated another way, their demands will result in more deaths than lives saved.

Nocera and Myers Hit Nail on the Head: FDA Should be "Pilloried" for Forcing E-Cigarette Companies to Hide the Truth from Consumers

New York Times columnist Joe Nocera and Campaign for Tobacco-Free Kids' director Matt Myers have hit the nail on the head. In an incisive Times commentary last Friday, Nocera insightfully digs down to expose the core problem regarding the government's and the anti-smoking movement's treatment of electronic cigarettes: The anti-smoking groups' have confused the public about the relatively safety of e-cigarettes compared to smoking, and the government (is poised to) prohibit the e-cigarette companies from correcting this fallacy. As a result, rather than promoting their products based on their main benefit (being much safer than cigarettes and not containing any tobacco), they are left to market their products in ways that might appeal to youth (as a sexy, cool, digital alternative tobacco product). And Myers adds that it is the FDA's fault for sitting by for six years and allowing this situation to get out of control.

Nocera writes: "Two weeks ago, I received an email from NJOY, a company that sells electronic cigarettes. Its purpose was to introduce the Daily, a new product that NJOY described as “a superior e-cigarette scientifically developed to deliver quick-and-strong nicotine satisfaction at levels close to an actual cigarette.”An e-cigarette that could truly replicate the experience of smoking would dramatically reduce — not eliminate, but reduce — the dangers of smoking. NJOY claims that the Daily comes closer to that experience than anything on the market." ...

"I thought to myself, “The tobacco-control community is going to hate this thing.” Most anti-tobacco advocates view replicating the feel and satisfaction of a cigarette as an effort to “renormalize smoking.” And though some believe that smokers should be encouraged to move to e-cigarettes, most refuse even to acknowledge the health benefits of “vaping” over smoking. Indeed, thanks to this vociferous opposition, an increasing number of Americans view vaping as no safer than smoking, which is absurd. And e-cigarette manufacturers like NJOY can’t set them straight: The law giving the Food and Drug Administration regulatory authority over tobacco products, which passed in 2009, prohibits e-cigarette companies from making reduced-harm claims unless they jump through some near-impossible hoops. Thus, NJOY has no way to convey to adult smokers the critical message that e-cigarettes could save their lives." ...

"One thing that particularly bothers Myers about e-cigarette companies is their advertising, which he believes employs the same tactics Big Tobacco once used to hook youths on cigarettes. But when I noted that NJOY can’t market the Daily as a reduced-risk product, thanks to the 2009 law — and thus had to find less straightforward ways to induce smokers to try the product — Myers told me that I should blame the F.D.A., which, six years in, has yet to impose a single regulation on e-cigarettes. “I think the F.D.A. deserves to be pilloried,” he said."

The Rest of the Story

This is a critical commentary, and I'm glad that it received prominent attention in the New York Times. It exposes what I think is the most serious problem regarding the treatment of e-cigarettes, by both the anti-tobacco movement and the government.

The anti-tobacco movement's treatment of e-cigarettes has been a public health disaster because the overwhelming majority of the movement has misled the public into believing that vaping is just as harmful as smoking. Most health groups have failed to acknowledge that e-cigarettes have helped thousands of smokers to quit and that these devices have improved the health of tens of thousands because they are so much safer than tobacco cigarettes. This campaign of deception has been successful: the public is completely confused about the relative safety of real and fake cigarettes. And the campaign has been damaging: the public's appreciation of the severe hazards of smoking has been undermined, and quitting has largely been discouraged.

The FDA's treatment of e-cigarettes has also been a public health disaster. By vowing to regulate e-cigarettes in the same way as tobacco cigarettes, the agency has effectively precluded e-cigarette companies from telling the public the truth about their products and thereby mitigating the lies coming out of the anti-tobacco community. There are three major problems:

First, by subjecting e-cigarettes to the modified risk provisions of the Tobacco Act, as the FDA seems poised to do, the agency would prohibit the e-cigarette companies from telling their consumers the truth: that e-cigarettes are much safer than tobacco cigarettes. Despite the lies coming out of many anti-tobacco groups, there is no dispute in the scientific community that this is factually accurate. Even Stan Glantz acknowledges this basic fact. But by subjecting e-cigarettes to section 911, the FDA would prohibit companies from telling the public this basic truth. 

Second, by subjecting e-cigarettes to the reduced exposure provisions of the Tobacco Act, as the FDA seems poised to do, the agency would prohibit the e-cigarette companies from telling their consumers the most important piece of consumer information about these products: that they do not contain any tobacco. Why? Because such a claim would be considered a reduced risk claim, which cannot be made without FDA authorization. And to get that authorization, an e-cigarette company would have to demonstrate that making the claim would not lead smokers to think that e-cigarettes are safer than tobacco cigarettes. But that is obviously impossible. Moreover, it would defeat the whole purpose of making the claim. Thus, it is a de facto ban on e-cigarette companies telling consumers that their product is free of tobacco. 

Third, by disallowing companies to market their products based on their real and intended benefits (their relative safety compared to smoking), the FDA has left the companies with no choice other than to promote these products based on features like sexiness, glamour, coolness, and popularity, which cause this marketing to appeal to young people. In contrast, if the e-cigarette companies could market these products as a crutch for smokers who cannot break their addiction without going through the actual motions of smoking, their marketing would be a whole lot less appealing to youth. After all, kids aren't exactly running out the door to purchase over-the-counter smoking cessation products which deliver plenty of nicotine.

Nocera and Myers are correct that it is the FDA's fault. By simply issuing a regulation or even an advisory that e-cigarettes will not be subject to section 911, this problem could have been averted. 

In fact, it is not too late. The only error in Nocera's column is the statement that the 2009 Tobacco Act prohibits the e-cigarette companies from making reduced risk claims. The 2009 law doesn't itself apply to e-cigarettes. However, as we know, the FDA will soon issue deeming regulations that will apply the 2009 law to e-cigarettes. And the proposed regulations made it clear that the agency's intent is to apply section 911 - the modified risk provisions - to e-cigarettes and vaping devices. 

But the FDA does not have to take this action. Instead, it could carve out a separate regulatory framework for e-cigarettes by releasing them from adherence to section 911. The FDA could decide that telling consumers the truth about e-cigarettes is to the great benefit of the public's health, and that applying section 911 to these products is therefore unwarranted. The FDA could also recognize that prohibiting e-cigarette companies from telling the truth about their products is likely a violation of the free speech rights of the companies and could likely be successfully challenged in court. 

It is now only a matter of weeks, or months, before we find out how the FDA decided to handle e-cigarettes. My hope, of course, is that it chose to exempt e-cigarettes from section 911. However, based on the proposed deeming regulations, it does not look like that is likely to be the case.

American Lung Association: Real Cigarettes are No More Hazardous than Fake Ones

In a lie of epic proportions, the American Lung Association of the Upper Midwest has publicly claimed that smoking real (tobacco) cigarettes may be no more harmful than using fake (electronic) cigarettes, which contain no tobacco and involve no combustion. This despite a multitude of evidence that e-cigarettes are much safer than tobacco cigarettes. A recent Public Health England report concluded definitively that e-cigarettes are much safer than real cigarettes, and even Dr. Stan Glantz - a notorious e-cigarette demonizer - admits that e-cigarettes are much safer than real ones.

According to an article in the Minnesota Daily:

"A new trend in switching traditional cigarettes for e-cigarettes and vaporizers has become prevalent among millennials despite a lack of evidence those devices are safer, said Regional Senior Director of the American Lung Association of the Upper Midwest Pat McKone. “We do not have enough information about e-cigarettes or vape-pens to determine whether they are a healthier alternative or if they have serious long-term effects that could be detrimental to health,” she said."

In the same article, an assistant professor of medicine at the University of Minnesota was cited as stating that e-cigarettes may be no safer than real cigarettes in terms of their respiratory health effects:

"Because cigarette smoke and particles are the most damaging effects of smoking, Begnaud said, she doesn’t think e-cigarettes or vaporizers — which also produce harmful vapors — are healthier for the lungs." 

The Rest of the Story

Given the multitude of evidence that e-cigarettes are not nearly as harmful as real cigarettes, how can the American Lung Association possibly tell the public that smoking may be no more hazardous than vaping?

And given research showing that e-cigarette use, unlike real cigarette use, does not impair respiratory function as measured by spirometry, along with research showing marked improvement in respiratory symptoms and lung function of smokers who switch to vaping, how can a professor of medicine possibly tell the public that e-cigarettes are not healthier for the lungs compared to real tobacco cigarettes?

These statements are not only lies but they are irresponsible lies. They are also damaging because they undermine the public's appreciation of the severe hazards of smoking.

It is baffling to me how anti-tobacco advocates and organizations are so threatened by electronic cigarettes that they have completely forgotten how harmful smoking is and how much disease and death is being caused by tobacco-containing, combustible cigarettes. They are so threatened by electronic cigarettes that they have resorted to lying in order to demonize these products.

The rest of the story is that anti-tobacco advocates and groups are so threatened by electronic cigarettes that they are actually promoting cigarette smoking as being no worse than using a non-tobacco-containing product. They have completely transformed the tobacco epidemic from a problem of tobacco use to a problem of nicotine use. The problem now is addiction itself, not disease and death.

In other words, the tobacco epidemic is no longer a public health issue, it is a moral one.

The tobacco control movement, then, is no longer a part of public health practice. It is now little more than a moral crusade, spewing hysterical, unsupported, and misleading claims and blatant lies that in the end are serving to promote and preserve the sales of the most hazardous consumer product on the market: real cigarettes.

CDC Continues to Mislead the Public by Classifying E-Cigarettes as Tobacco Products and Not Admitting that They Contain No Tobacco

The Centers for Disease Control and Prevention (CDC) continues to mislead the public by classifying electronic cigarettes as tobacco products and by failing to inform the public that electronic cigarettes contain no tobacco. In yet another MMWR article on "tobacco product" use, the CDC includes electronic cigarettes in the category of tobacco products, along with five other products which actually do contain tobacco: cigarettes, smokeless tobacco, hookah tobacco, cigars, and pipe tobacco. At the same time, the article fails to disclose the fact that electronic cigarettes, unlike any of these other five products, do not contain any tobacco.

The Rest of the Story

The CDC is misleading the public by failing to tell the truth about electronic cigarettes. These products do not contain tobacco and therefore should not be classified as tobacco products in epidemiologic studies such as the one reported above by the CDC. Moreover, the CDC should disclose the important fact that e-cigarettes contain no tobacco.

In fact, I can find no article anywhere on the CDC web site where the agency acknowledges that e-cigarettes contain no tobacco. Even it its fact sheet of vital information about e-cigarettes, the CDC omits the vital fact that these products do not contain tobacco.

It truly appears that the CDC is intentionally hiding from the public the important fact that e-cigarettes contain no tobacco. The apparent motive is to demonize electronic cigarettes by making them appear much more hazardous than they really are. Moreover, by equating e-cigarette use and smoking, the CDC is misleading the public into thinking that e-cigarettes really don't offer any health advantage over smoking. This is devastatingly damaging information, and it is irresponsible for the CDC to be engaging in such an unethical communication campaign.

New Article Demonstrates Severe Bias by Anti-Tobacco Researchers in the Communication of Scientific Results about E-Cigarettes

A paper published this week online ahead of print in the journal Current Environmental Health Reports concludes that "secondhand" exposure to exhaled e-cigarette aerosol is toxic because it contains particulate matter.

(See: Fernandez E, et al. Particulate Matter from Electronic Cigarettes and Conventional Cigarettes: a Systematic Review and Observational Study. Current Environmental Health Reports. October 9, 2015.)

The methodology of this study was very simple: "We measured PM_2.5 [fine particulate matter] in four different homes: one from a conventional cigarette smoker, one from an e-cigarette user, and two from non-smokers."

The purpose of the study was to compare the level of particulates generated by cigarettes and e-cigarettes to the baseline level of these particulates in the air of homes without any smokers or vapers.

Here are the results for the median PM2.5 levels (in micrograms per cubic meter):

Home with smoker: 572.52
Home with vaper: 9.88
Smoke-free, vape-free home: 9.53
Smoke-free, vape-free home: 9.36

In other words, the study found no difference in median levels of fine particulates in homes with vaping taking place compared to completely smoke-free and vape-free homes. However, the levels of fine particulates in secondhand tobacco smoke were about 60 times higher than in the homes with no smoking.

The study concludes that: "the observational study indicates that e-cigarettes used under real conditions emit toxicants, including PM_2.5."

The Rest of the Story

The actual finding of the study is that the air in homes where vaping is taking place is no more dangerous than that in homes with no smoking or vaping, at least in terms of fine particulate matter exposure.

However, instead of reporting this actual finding, the article concludes that exposure to exhaled e-cigarette aerosol is toxic because it contains fine particulate matter.

The truth is that exposure to the e-cigarette aerosol is no more "toxic" than baseline exposure in a completely smoke-free, vape-free home. In other words, in terms of fine particulate matter exposure, secondhand vaping appears to represent no risk.

But the average reader would not come to this actual conclusion because the paper hides it. It has the appearance that because the results didn't come out the way the authors wanted it to, they misreported the conclusion to conform with what was apparently their predetermined conclusions against e-cigarettes.

This is a fine example of severe bias by anti-tobacco researchers in the reporting of scientific results about e-cigarettes. Sadly, it is just one of many examples we have seen in recent years.

The rest of the story is that many anti-tobacco researchers, advocates, and groups have a strong bias against e-cigarettes, and this bias is being reflected in their misrepresentation of the evidence from scientific studies of these products.

Not only can't the public trust information they are hearing about e-cigarettes from anti-smoking and health groups, they cannot even trust the information being reported in the scientific literature itself!


(Thanks to Dr. Peter Hajek for the tip and idea.)

Anti-Smoking Researcher: Cutting Down on the Amount You Smoke Has Benefits if You Cut Down Using Low-Nicotine Cigarettes, But Not if You Use E-Cigarettes

In a Jekyll and Hyde fashion, Dr. Stan Glantz has taken two opposite positions on the issue of whether reducing cigarette consumption can convey health benefits. If you reduce cigarette consumption using e-cigarettes, it has no health benefits, Glantz says. But if you reduce cigarette consumption by switching to low-nicotine cigarettes, it does have health benefits, according to Glantz.

In his comments on the recent study of low-nicotine cigarettes, Dr. Glantz insinuates that reducing the amount you smoke does have health benefits, and he applauds low-nicotine cigarettes for what he suggests is the benefit of helping smokers reduce the amount that they smoke.

However, in commenting on electronic cigarettes, Dr. Glantz argued that cutting down substantially on the amount you smoke has no health benefit. Thus, according to Dr. Glantz, smoking two packs of cigarettes per day is no more harmful than smoking a half pack per day, for example.

Dr. Glantz's comments on the lack of health benefit in cutting down on one's smoking came in response to one of the reported benefits of electronic cigarettes: that they help many smokers to cut down substantially on the amount they smoke. Glantz wrote: "Dual users, who simultaneously use both products, are unlikely to see much, if any, health benefit because of the continued cigarette use, even if daily consumption drops." In other words, if you are still smoking, there are no benefits from cutting down on the amount you smoke thanks to e-cigarettes.

This is actually an important point because in published studies of the efficacy of electronic cigarettes, they reportedly helped more than half of smokers to either quit completely or cut down the amount they smoked by 50% or more. Thus, electronic cigarettes - even dual use - results in a substantial decline in cigarette consumption for the majority of users.

The Rest of the Story

This story illustrates the tremendous bias present among many anti-tobacco groups and advocates. I discussed this bias yesterday in revealing how anti-tobacco groups have embraced low-nicotine cigarettes as a smoking cessation strategy while shunning e-cigarettes, despite evidence that low-nicotine cigarettes have no effect on cessation or reducing cigarette consumption while e-cigarettes do.

Here, Dr. Glantz would have us believe that if you reduce your cigarette consumption using low-nicotine cigarettes, it will have a health benefit, but if you reduce your consumption using e-cigarettes, it will not have a health benefit. Of course, this is impossible because your body doesn't know how you cut down on the amount you smoke; it just responds to the amount of cigarette smoke that you are inhaling.

But it would not have been convenient for Dr. Glantz to argue that cutting consumption has health benefits in the context of e-cigarettes because he has apparently reached a pre-determined conclusion that e-cigarettes are evil and aims to demonize them every chance he gets. He clearly has a bias towards continued consumption of tobacco cigarettes, for a reason that makes no public health sense but will certainly aid cigarette company profits.

The public should not trust information they receive from anti-smoking groups any longer. We are no longer a credible source for scientific or public health information. You're better off going with the tobacco companies, or Wikipedia!

Bias in Anti-Tobacco Movement is Laid Bare: If You Don't Quit the Way We Want You to Quit, Then Don't Bother

After last week's publication of a new study which found that smokers switching to very low-nicotine cigarettes did not compensate by smoking more, anti-tobacco groups jumped on the bandwagon, telling the public that these products helped smokers cut down and quit and should therefore be an integral part of a national smoking cessation strategy.

For example, as I revealed on Monday, three anti-tobacco groups - the Campaign for Tobacco-Free Kids, the American Legacy Foundation, and the Center for Tobacco Control Research & Education - have embraced low-nicotine cigarettes as an effective smoking cessation tool.

At the same time, each of these groups (as well as most anti-tobacco groups) has rejected electronic cigarettes as a legitimate smoking cessation strategy.

But let's look at the actual evidence regarding the effect of switching to either low-nicotine cigarettes or electronic cigarettes among smokers who have no desire to quit smoking. The Donny et al. study, published last week in the New England Journal of Medicine, provides data on changes in cigarette consumption among smokers with no desire to quit who were assigned to smoke very low-nicotine cigarettes. Similarly, an earlier study by Caponnetto et al. provides data on changes in cigarette consumption among smokers with no desire to quit who were assigned to use electronic cigarettes.

In the low-nicotine cigarette study, smokers provided with low-nicotine cigarettes failed to reduce their cigarette consumption significantly over a six-week period, and their quit rate was not significantly different than the control group of usual brand smokers.

In the electronic cigarette study, 13% of smokers assigned to a high nicotine e-cigarette quit smoking at one year, and an additional 10% of smokers reduced their cigarette consumption by more than 50%. 

These results are not exactly comparable because the low-nicotine cigarette study only followed subjects for six weeks. At six weeks, 9% of the electronic cigarette users had quit smoking, and an additional 24% had reduced their cigarette consumption by at least 50%.

The Rest of the Story 

Despite the findings that low-nicotine cigarettes failed to result in a significant increase in quitting or in any reduction in cigarette consumption, while the electronic cigarettes resulted in a substantial proportion of smokers who quit or greatly reduced their cigarette consumption, anti-tobacco groups have concluded that low-nicotine cigarettes help smokers quit and cut down, while electronic cigarettes do not. The conclusion of the anti-tobacco groups is exactly the opposite of what the data show.

This reveals a huge bias in the anti-tobacco movement. But it is a strange bias because it actually favors deadly tobacco cigarettes over much safer electronic ones. Why is it that anti-tobacco groups are completely misrepresenting the scientific evidence, lying to the public, and embracing a strategy in which combustible tobacco products remain the mainstay of nicotine use instead of one in which combustible tobacco products could become obsolete?

I believe the explanation is that "we" thought of the idea of nicotine reduction, but not the idea of electronic cigarettes. Thus, we don't really want to see e-cigarettes work, while we'd love to see low-nicotine cigarettes work. The end goal, you see, is not to save lives by getting smokers to quit. Instead, the end goal is to be able to claim victory by getting smokers to quit in the way we want them to quit. And if such a strategy results in far few smokers quitting, it doesn't matter. The movement is now concerned more with money and prestige than with reducing morbidity and mortality. (See my earlier commentary for a more detailed synthesis of this point.)

As I wrote earlier: "I firmly believe that if the idea of an electronic cigarette was conceived by individuals, researchers, or groups within the tobacco control movement, our reaction to these products would be completely different. It would not represent a threat to our status and prestige because we could claim credit for the "victory," for the accomplishment, for the transformation of the tobacco industry, for the unprecedented magnitude of the saving of lives."

But e-cigarettes are not our baby. Instead, we're casting our lot with a strategy for which there is no evidence. But it doesn't matter because it's our strategy. And it doesn't matter if the strategy is not as effective as e-cigarettes because it's not the saving of lives that matters most. It's retaining our ideology and our prestige.

Anti-Tobacco Groups Publicly Lie About the Effects of Low-Nicotine Cigarettes; Our Honesty is as Bad as the Tobacco Industry of Old

One of the core principles of public health is honesty. Our ethical code requires that we tell the truth to the public about potential health hazards. The ethical code goes even further by invoking the principle of transparency. Not only must we tell the truth, but we must tell the whole truth, so as not to mislead the public.

One thing that used to distinguish the anti-tobacco movement from the tobacco industry is that we always told the truth while the industry often lied. Unfortunately, and ironically, the tables have now turned.

Sadly (but not surprisingly to me at this point), several anti-tobacco groups are lying to the public by informing them that a new study, published last week in the New England Journal of Medicine, showed that low-nicotine cigarettes helped smokers quit.

The groups lying to the public are:

• the Campaign for Tobacco-Free Kids;
• the American Legacy Foundation; and
• the Center for Tobacco Control Research & Education at UCSF.

According to the Campaign for Tobacco-Free Kids: "This study indicates that by significantly reducing the nicotine content of cigarettes, it is possible to reduce the addictiveness of cigarettes to help more smokers quit."

According to the American Legacy Foundation, this new study shows that: "low nicotine products can reduce addictiveness and lead to quitting. ..."

According to Dr. Stan Glantz of the Center for Tobacco Control Research & Education at UCSF, the new study "shows smokers smoke less and quit more after big cuts in nicotine in cigarettes."

The Rest of the Story

The rest of the story, quite simply, is that all three of these groups are lying to you.

Let's look at the actual data from the study:

The study measured the likelihood of subjects continuing to smoke at 30-day follow-up for each of the assigned study groups. By comparing the differences in the likelihood of quitting, the study was able to determine whether subjects in the low-nicotine group were more or less likely to quit smoking compared to the high nicotine groups (see Table S-10).

According to the table, in adjusted logistic regression models, compared to smokers who were assigned to smoke their usual brand of cigarettes, smokers in the low-nicotine (0.4 mg) group were equally likely to have quit at 30-day follow-up. Specifically, there was no statistically significant difference in the proportion of quitters between the low-nicotine cigarette smokers and the usual brand smokers.

Thus, these data do not indicate that smokers in the low-nicotine group were more likely to have quit smoking than those continued to smoke their brand as usual. In other words, this study failed to find that low-nicotine cigarettes had any significant effect in terms of helping smokers to quit.

Thus, by claiming that the study found that low nicotine cigarettes led to more quitting, all three of the above anti-tobacco groups are misrepresenting the study findings and lying to the public about the true reported results of the study.

Furthermore, as I discussed last week, the study did not even find that the smokers of low-nicotine cigarettes cut down on the amount they smoked. In fact, there was no change in cigarette consumption among the low-nicotine smokers from baseline to six-week follow-up. Thus, the conclusion that smokers who switched to low nicotine cigarettes reduced their consumption is also unsupported.

Finally, the study found no significant improvement in self-reported respiratory health among low nicotine smokers (see Tables S-40 to S-44) and no significant improvement in overall self-reported health (Table S-45).

The bottom line is that this study produced no evidence that low-nicotine cigarettes had any significant positive effects in terms of reducing cigarette consumption, quitting smoking, or improving health.

Even the reported finding in the paper that smokers of the low nicotine cigarettes were twice as likely to attempt to quit is highly misleading. The quit attempt proportions are only significantly different if you compare the low-nicotine group to the 15.8 mg group. But if you compare the low-nicotine group to the usual brand group (which, to me, is the most appropriate comparison), there was no significant difference in the proportion of subjects who attempted to quit smoking (Table S-12). This is an important finding which all three of the anti-tobacco groups fail to disclose to the public.

What the anti-tobacco groups are doing is really no different than what tobacco companies used to do in their public communications. Lying is lying, and it isn't justified when anti-tobacco groups are doing it but unjustified when tobacco companies are doing it. For a movement which has spent so much time and effort criticizing the tobacco industry for lying to the public, it seems wholly unacceptable that we are now doing the same thing.

While I am not comparing the damage done by the tobacco industry's lies in the past to the damage being done by the anti-tobacco movement's lies, it is important to point out that there is still damage being done. If the lies being disseminated about low nicotine cigarettes end up affecting public policy, they could do real damage by promoting a policy that could end up being ineffective.

It is becoming clear to me that the public can no longer rely on anti-tobacco organizations to receive accurate scientific information about tobacco products. Ironically, they are presently getting more reliable information from the tobacco companies. This is a sad, but true state of affairs.

Contrary to the Way Results Were Reported, New Study Did Not Find a Reduction in Cigarettes Smoked with Low-Nicotine Cigarettes

New research published in the New England Journal of Medicine is widely being reported by anti-smoking groups and advocates as having found that subjects who received low-nicotine cigarettes significantly decreased their cigarette consumption. For example, the Campaign for Tobacco-Free Kids claimed that: "After six weeks, smokers given cigarettes with 2.4 mg of nicotine or less smoked significantly fewer cigarettes per day... ." Dr. Stan Glantz claimed that "smokers smoke less" after big cuts in nicotine in cigarettes. And the study itself concluded that "these data suggest that if nicotine content is adequately reduced, smokers may benefit by smoking fewer cigarettes... ."

The Rest of the Story

Once again, these anti-smoking groups and advocates are deceiving the public. The truth is that the study found no significant change in cigarette consumption (the number of cigarettes smoked per day) among smokers assigned to the very low-nicotine cigarettes. Subjects assigned to smoke the very low-nicotine cigarettes smoked an average of about 15 cigarettes per day at baseline and an average of about 15 cigarettes per day at follow-up. Thus, there was essentially no change in their cigarette consumption. Moreover, the exhaled carbon monoxide levels did not change significantly among the very low-nicotine group, indicating no significant reduction in tobacco smoke exposure.

The study did find a significant difference in the number of cigarettes smoked at follow-up between the very low-nicotine and higher nicotine groups. The mean difference in cigarette consumption between the groups was significant. This is because cigarette consumption among the higher nicotine groups actually increased.

These data do not support the conclusion that very low-nicotine cigarettes result in a significant reduction in the number of cigarettes smoked per day among smokers switching to such products. In fact, there was no observed reduction in cigarette consumption at six weeks, so such a conclusion cannot be supported by these data. But at very least, the reports that smokers smoke less after cuts in nicotine or that smokers given low-nicotine cigarettes smoked fewer cigarettes afterwards are incorrect.

It is difficult for me to see how a study which found no significant change in cigarette consumption among smokers who switched to very low-nicotine cigarettes can possibly support the conclusion that regulating nicotine levels in cigarettes would result in a significant reduction in cigarette consumption among smokers. Such a conclusion appears to reflect a bias in the interpretation of the study results that favors a nicotine regulation policy.

In contrast, there is strong evidence that switching to electronic cigarettes results in a substantial reduction in cigarette consumption. The majority of smokers in a similar clinical trial of e-cigarettes cut their actual cigarette consumption by more than 50%.

So why is it that anti-smoking groups and advocates are jumping on top of the idea of very low-nicotine cigarettes but completely shunning the idea of e-cigarettes?

The answer is simple: ideological bias.

NEJM Commentary Written by Anti-Tobacco Researchers Hides Conflicts of Interest with Big Pharma

An article published today in the New England Journal of Medicine discusses the results of a clinical trial of low-nicotine cigarettes for reducing smoking. The article recommends that low-nicotine cigarettes should be a part of a national strategy to reduce tobacco use. However, it fails to recommend that electronic cigarettes be considered as a part of this strategy, even though e-cigarettes are much more effective in getting smokers to cut down on the amount they quit, much more effective in getting smokers to quit completely, and much safer. But e-cigarettes are a threat to pharmaceutical companies that manufacture smoking cessation drugs. Therefore, readers may naturally be curious whether the authors of this commentary have any history of financial conflicts of interest with pharmaceutical companies.

Fortunately, readers can be rest assured that there were no relevant conflicts to disclose. Both of the co-authors - Dr. Michael Fiore and Dr. Timothy Baker - completed disclosure forms indicating that they have nothing to disclose, which implies that there is no relevant history of financial relationships of any of these authors with pharmaceutical companies.

Specifically, in completing section 5 of the form, each of the authors proclaimed that there were: "No other relationships/conditions/circumstances that present a potential conflict of interest." This section refers to financial interests that were not disclosed earlier in the form. The disclosures earlier in the form relate to financial interests present during the past 36 months. Importantly, however, the additional disclosures in section 5 do not have any stated time frame. The directions indicate that authors must "use this section to report other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what you wrote in the submitted work."

Since both authors indicated in section 5 that there are no other relationships or activities that readers could perceive to have influenced their work, we are led to believe that neither of these authors has any significant history of financial relationships with Big Pharma.

The Rest of the Story

The rest of the story is that both authors are hiding relevant financial conflicts of interest with Big Pharma that I believe should have been disclosed in the paper.

Dr. Fiore

The truth is that Dr. Fiore actually has a long history of significant financial relationships with pharmaceutical companies that manufacture smoking cessation drugs, none of which are acknowledged in his disclosure. Here is what is being hidden from readers:

1. According to his own 2008 JAMA article: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

2. According to his own sworn testimony, at the time of his chairing in 2008 of an expert NIH panel to make recommendations about the recommended clinical strategies for promoting smoking cessation, Dr. Fiore received up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

3. In 2006, Dr. Fiore acknowledged that "I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

4. In 1998, the University of Wisconsin appointed him to a named chair, made possible by an unrestricted gift to the University from GlaxoWellcome.

5. In the past, "Dr. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."

6. Dr. Fiore directs a tobacco research center that received nearly $1 million in funding from makers of quit-smoking medicine in 2004 and $400,000 in 2005.

7. In a recent set of two articles on treatment for smoking cessation published in the Annals of Behavioral Medicine in April 2011 (article 1; article 2), the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Michael C. Fiore served as an investigator on research studies at the University of Wisconsin that were funded by Nabi Biopharmaceuticals."

8. In a December 2010 article on treatment for smoking cessation published in the Wisconsin Medical Journal, the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Dr Fiore has served as an investigator in research studies at the University of Wisconsin that were funded by Pfizer and Nabi Biopharmaceuticals."

Amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma. I imagine that most readers would be shocked to find out about this intense and long history of financial conflict with Big Pharma, given that Dr. Fiore reported no conflicts of interest.

Dr. Baker

The truth is that Dr. Baker also has a long and significant history of financial relationships with pharmaceutical companies that manufacture smoking cessation drugs. Here is what is being hidden from readers:

1. In 2008, Dr. Baker reported that: "he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

2. In 2000, Dr. Baker disclosed as follows: "Timothy Baker has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, and Lederle."

3. As recently as 2012, Dr. Baker disclosed in an article that his research involved financial support from GlaxoSmithKline in the form of free medication provided to study participants.

4. In another 2012 paper, Dr. Baker also acknowledged that GlaxoSmithKline provided financial support in the form of free study medication. The same disclosure was made in another 2012 paper. And in another paper as well.

5. According to a 2011 paper: "Timothy B. Baker has served as a consultant, given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline, Nabi Biopharmaceuticals, Pfizer, and Sanofi-Synthelabo."

6. In a 2010 paper, Dr. Baker acknowledged "research grants from Pfizer, GlaxoSmithKline, Nabi Biopharmaceuticals, and Sanofi."That paper itself involved research with financial support from GlaxoSmithKline in the form of free study medication.

Again, amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma.

Summary

For years, we in tobacco control have attacked tobacco industry-funded scientists or researchers who consulted for tobacco companies for not disclosing their conflicts of interest. It is therefore quite unfortunate, and ironic, that tobacco control researchers do not appear to take their own conflicts of interest seriously and that they, too, are hiding these conflicts from the public.

As I previously articulated, the hiding of these conflicts of interest damages public health in four ways:

1. It violates public health ethics and could be damaging to the entire field of tobacco control;
2. It degrades the research integrity of tobacco control;
3. It makes us hypocrites when we criticize failed tobacco industry disclosures; and
4. It hides the influence of Big Pharma money on the field of tobacco control and hinders smoking cessation efforts.

New Study Violates Research Ethics by Assigning Subjects to Smoke, Instructing Them to Smoke, and Failing to Provide Mandated Care

A study published today in the New England Journal of Medicine describes the results of a clinical trial in which adult smokers who expressed no intent to quit at baseline were randomly assigned to smoke their regular brand of cigarettes or reduced nicotine cigarettes at varying levels of nicotine.

(See: Donny EC, et al. Randomized trial of reduced-nicotine standards for cigarettes. New England Journal of Medicine. Published online ahead of print on October 1, 2015. DOI: 10.1056/NEJMsa1502403.)

According to the study: "Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6."

The results of the study, which were accompanied by an editorial, have been widely reported in the media. However, I have not seen any discussion of the ethics of this study.

The Rest of the Story

A basic principle of human subjects research is that of non-maleficence, or doing no harm. Also critical is the principle of harm minimization. You cannot knowingly put human subjects in harm's way when there is an alternative that is safer and will still answer the research question at hand. In particular, subjects being treated in a medical setting must, at a minimum, receive the standard level of care for the disease, condition, or behavior being studied.

This issue arises because most clinical trials involve randomization of subjects to receive an investigational treatment or no treatment. However, when someone has a medical condition, it is obviously not ethical to provide them with no treatment. Therefore, it is well recognized that subjects must, at a minimum, be offered the standard or usual treatment for that disease, condition, or behavior.

For example, suppose you want to investigate the effectiveness of a potential new treatment for severe hypertension (high blood pressure). The treatment involves a new drug. You cannot randomize patients to receive either the new drug or a placebo because it would be unethical to deprive subjects who have severe hypertension of any treatment. At a minimum, you would have to provide the control group with the minimum standard of care, which would almost certainly involve treatment with a standard drug usually used to treat high blood pressure.

In fact, the failure to provide standard care is one of the main problems in the tragic Tuskegee study, which is what in many ways led to the promulgation of ethical standards in research with human subjects. In that study, subjects with syphilis were randomized to receive antibiotic treatment or no treatment. It was unconscionable that subjects were left untreated when there was a known treatment available.

Believe it or not, this same failure occurred in the present study, although obviously not as blatantly or with as tragic the consequences. Nevertheless, the violation of basic research ethics was similar.

In the present study, smokers were assigned to either smoke their usual brand of cigarettes or to smoke a low-nicotine cigarette (at varying levels of nicotine). They were instructed to smoke the assigned cigarettes for six weeks. Although the subjects were free to quit smoking, they were not encouraged to quit unless they informed study staff that they had tried or intended to make a quit attempt.

According to the study protocol: " Participants will be instructed to use the research cigarettes for 6 weeks, at which point they are to discontinue product use." In other words, study subjects were instructed not to quit smoking for at least six weeks!

Moreover, the study protocol did not call for encouraging research participants to quit smoking, nor did it call for providing all subjects the usual standard treatment for smokers, which consists - at very least - of advising patients to quit. In a non-research setting, it would probably represent medical malpractice for a physician to instruct a patient to continue smoking for six weeks. At very least, there is an obligation - under standard medical principles - to advise the patient to quit smoking. Even less acceptable would be to make no recommendation regarding smoking. But to actively instruct the patient to continue smoking would be unethical.

The problem is compounded by the fact that study subjects were provided with a free 14-day supply of cigarettes. Not only does this make it more difficult for them to quit smoking, but it encourages them to continue smoking and sends the implicit message that if they don't continue to smoke, they are violating study protocol. It appears that the subjects were not explicitly told that quitting smoking is encouraged and will not violate the protocol or endanger their receiving compensation in any way.

Furthermore, offering smokers treatment with a smoking cessation medication and/or referral to a smoking cessation clinic or program is not only usual care, but it is actually mandated under the hospital accreditation standards.

The ethical breach becomes even more serious when one examines the informed consent form used in the study. The form states as follows:

"You will smoke your assigned cigarette for the remainder of the study. We will give you more than enough cigarettes to replace the amount that you usually smoke each week. We will ask you to try to smoke only the cigarettes we give you. We will work with you to achieve this goal as it is very important for the study."

Here, subjects are being told that they will smoke their assigned cigarette for the entire six weeks of the study. Moreover, they are informed that their continuously smoking their assigned cigarette brand for six weeks is a goal of the study and is very important. The implication, of course, is that if a subject quits smoking, he or she is not following the protocol and is compromising the study.

Although subjects are later informed that they may quit if they want, nowhere are they encouraged to quit smoking.

Finally, nowhere in the consent form are subjects told that one of the risks of the study is that by continuing to smoke for six weeks rather than quitting, they are subjecting themselves to the risk of health damage from continued smoking. The form does not acknowledge that one of the risks of participation in the study is that it could impede quitting, at least for six weeks.

To me, what puts the nail in the coffin of the ethical breach in this study is that there is an alternative approach that would have yielded the same information, but without violating ethical principles. An alternative approach would have been to encourage all subjects to quit smoking, refer them to smoking cessation clinics or programs, and offer to provide them with nicotine replacement therapy or other treatment. Because the smoking cessation rate with "FDA-approved" or "hospital-mandated" treatment is so low, such a procedure would not have interfered significantly with the ability of the study to answer the research question at hand. If anything, it would have added to the importance of the research by examining the critical question of whether low-nicotine cigarettes can actually enhance smoking cessation.

The rest of the story is that this study violated basic principles of ethical research conduct by failing to provide standard of care treatment for smokers being seen and treated in a medical setting. Even worse, smokers were in fact assigned to smoke, instructed to smoke, and led to believe that the protocol called for them to continue to smoke for the entire study period (which it did). In addition, subjects were not adequately informed of the study risks.

As Youth Smoking Rates Continue to Plummet, Anti-Smoking Advocates Continue to Claim E-Cigarettes are a Gateway to Youth Smoking

New data from the Florida Department of Health show that in 2015, smoking among Florida youth dropped to its lowest all-time level, with only 6.9% of high school students reporting past 30-day use of cigarettes. The sharp decline in youth smoking occurred contemporaneously with the tripling of e-cigarette use among Florida youth during the past two years.

Nevertheless, health officials continue to claim that e-cigarettes are a gateway to youth smoking and that e-cigarettes are normalizing smoking. According to an article in the Gainesville Sun:

"After decades of aggressive work to try to keep teens from picking up the deadly habit, health officials worry that e-cigs will undo that progress. ... the increase in e-cig use has the potential to normalize smoking again after decades of work to stigmatize it, the health department's Community Health Promotion Division Director Shannon Hughes said in a press release."

The Rest of the Story

The rest of the story is that the claims of anti-smoking advocates are simply not supported by the available data. If e-cigarette experimentation were a significant gateway to youth smoking, or if vaping normalized smoking, we would not expect to see youth smoking plummeting in the past two years, dropping to its lowest historic levels, at the same time as e-cigarette use among youth has tripled.

The truth is that the advent of e-cigarettes has made smoking even less attractive because there is a safer, cleaner, tastier alternative. Vaping is unquestionably contributing to a further denormalization of smoking. The truth is the exact opposite of what many anti-smoking groups are claiming.

It is time for anti-smoking advocates to recognize that the only thing vaping is normalizing is vaping. Although short-term use of electronic cigarettes does not appear to pose any significant health risk (other than to pregnant women), the spread of e-cigarette use among youth is still concerning. But it is not concerning because it is leading to smoking. It is concerning because many youth are now vaping. Ultimately, we don't want to see youth using nicotine at all. But the problem needs to be defined accurately.

What is contributing to the renormalization of smoking are the actions of anti-smoking groups, who have misled the public into believing that smoking is no more hazardous than using a non-tobacco-containing, non-combusted product. This has completely undermined the public's appreciation of the severe hazards of smoking. In fact, surveys have shown that a substantial proportion of the public actually believes that vaping is no safer than smoking. This is an untenable situation that normalizes smoking by demonizing electronic cigarettes and protecting cigarette sales. 

Health groups that continue to advise against the use of e-cigarettes in smoking cessation attempts, such as the American Academy of Family Physicians (AAFP), which recently issued a recommendation that physicians counsel against the use of e-cigarettes, are also contributing to the renormalization of smoking by helping to maintain cigarette use. The AAFP's recommendation, if followed by physicians, will lead to many smokers failing to quit and many ex-smokers returning to smoking because their doctors do not condone e-cigarette use.

Electronic cigarettes truly have the potential to be a game-changer in tobacco control. They could contribute to a massive transformation of the nicotine market in which combustible tobacco products eventually become obsolete. This is in fact the value proposition for all of the independent e-cigarette companies. But this transformation is being blocked by the unlikeliest of entities: the tobacco control movement itself.

FDA Completely Misinterprets Food, Drug, and Cosmetic Act in Warning Letters to E-Cigarette Company

My examination of the warning letter written by the FDA to Johnson Creek reveals that the agency is completely misinterpreting the Food, Drug, and Cosmetic Act's (FDCA) definition of what is considered a "therapeutic claim." This warning letter, issued in 2010 to Johnson Creek - an e-liquid manufacturer - asserted that certain claims being made by this company were therapeutic claims, and therefore, the products made by the company were considered drugs and had to be pulled from the market as they were not approved by the FDA as drugs.

However, upon examination, I found that this letter misinterpreted the meaning of "therapeutic claim" and used as evidence to support its assertion statements that do not actually represent therapeutic claims at all.

Below, I review many examples from the warning letter of the agency's misinterpretation.

The Rest of the Story

Examples of Purported Therapeutic Claims From the Letter to Johnson Creek

"If i had to wait two weeks, most likely I would have been back on smoke within a few days and I don't ever want to go there again, with as good as I feel right now. Daniel L. ... 

I have been off tobacco cigarettes for a week. I have been using an NJOY. I just received my first of many orders from your company. Norman S."

These two comments from customers simply express their experiences with electronic cigarettes. In both cases, these customers were able to switch completely from cigarettes to e-cigarettes. The company is not making any therapeutic claims, but is merely sharing the experience of customers who were able to switch from cigarettes to e-cigarettes. There is nothing in these comments which suggests that Johnson Creek e-liquids are intended either to prevent or treat any disease or to affect the function or structure of the body. Nothing in the comments expresses anything about improved health. They simply convey the fact that these individuals have switched from tobacco cigarettes to electronic cigarettes.

To see misguided the FDA is on this point, consider the following claim that is currently being made by GNC in the same context (a testimonial from a customer):

"GNC is the supplement industry leader in providing the highest quality supplements at an affordable price. I would like to thank GNC for making me a better athlete and a healthier person through the GNC supplements that I include in my daily nutrition."

Here, GNC is directly claiming that using its products will improve your health. This certainly seems like a therapeutic claim. After all, improving your health implies prevention of lack of health (i.e., disease or a harmful condition). This appears to run afoul of federal law, which prohibits nutritional supplements from making "disease" claims. The manufacturers of these products are not allowed to make any claim which states or implies that their products are intended to or can prevent a disease or adverse health condition. Apparently, the FDA does not view this as a health claim, since it allows claims like this to be made daily by GNC and similar companies. Also, the manufacturers are required to notify the FDA of the claims they are making, so presumably the agency is aware of this claim but has not taken any action against GNC, even though they are hounding Johnson Creek for making what is in comparison an innocuous claim.

Consider also the following claims which are being made by Faith & Family Nutrition, another nutrition supplement seller:

"J. Randsdorp on real pain relief without drugs or surgery
Dear Doctor, I saw you on TBN-TV ... I then ordered the vitamins for joint integrity, and I cannot believe I have my life back. I am a Christian, but everyday I had started my day with pain. After taking the vitamins, I painted a room! And now everyday when my feet hit the floor, it is without pain. I can't believe it but it’s true. I thank God for you. My right leg is completely pain free and there’s just a small amount in my left leg. — D.H., Monroe, La.
...He truly is doing better! His sense of humor has returned. He is already remembering words, not stammering over them. His 'pleasant' personality is being restored. His driving, which we could not get him to stop, is much better." (on Alzheimer's supplement recommendation plan) — R.D., Ortonville, Mich.

My husband has been taking the supplements for Alzheimer's for two months and is doing quite well. His long-term and short-term memory is starting to return. I took him out of the nursing home to give him the supplements, and the nurses at the nursing home are amazed at his improvement and want to know what he has been given. (on Alzheimer's supplement recommendation plan) — M.H. Huron, S.D.

My father was having epileptic seizures. Those stopped with the Relief Pills. He has trouble with short- and long-term memory and is doing much better. He is even seeing better: He can see colors now. Before he only had peripheral vision." (on Brain Food, Seizure Relief and other various supplements)
— C.S, Molalla, Ore.

I had a bad case of insomnia. I'm sleeping great now due to 5-HTP. And my husband's hair is growing thicker since taking IGF Growth Factor. — P.M., Nashville, Tenn.
I had a torn rotator cuff in my shoulder, and Natural Joint Integrity took away the pain. (The doctor said my shoulder was messed up pretty bad.) It also has helped my back. I used to get acupuncture, but haven't had to in a long time since taking Natural Joint Integrity. — D.W., Sullivan, Mo."
 
Here, the nutritional supplement company is making claims - presumably reviewed by the FDA and not judged to be disease claims - which directly assert that its products will relieve pain, treat the symptoms of Alzheimer's disease, prevent seizures in patients with epilepsy, treat insomnia, and relieve pain from a rotator cuff injury.

Yet the FDA does not consider these to be disease claims! Instead, it is writing threatening letters to companies whose testimonials do not even mention any disease or condition.

Other examples from the warning letter to Johnson Creek:

"E-Smoking vs. Cigarette Smoking ... To many who take up e-smoking, it completely takes over for regular cigarette smoking. In fact many report never picking up a cigarette again after starting to e-smoke ... 

Why E-Smoke? . .. Most people who smoke, do so because they enjoy the tactile, emotional and physical sensations. E-smoking provides pleasures similar to those commonly associated with traditional smoking ..."

The first claim simply notes that many customers were successful in switching from tobacco cigarettes to e-cigarettes. It doesn't mention or imply the prevention or treatment of any disease.

The second claim actually is an "anti-drug" claim. In other words, it makes it exquisitely clear that this product is meant to replace the physical and emotional stimuli associated with smoking, rather than to treat nicotine addiction. How does this statement possibly represent a therapeutic claim, especially in light of the "non-disease claims" being made by nutritional supplement companies?

In contrast, some of the claims being made by E-Cigarette Direct, another company to which FDA sent a warning letter, are therapeutic claims.

For example:

"Wean yourself off of nicotine and quit smoking for good! . . . Our new program is designed to naturally and slowly wean your body off of the nicotine cravings by slowly decreasing them. . . . The Nicotine Withdrawal System consists of everything you need to decrease your nicotine cravings over a period of 3-6 months, depending on how quickly you'd like to accomplish your goal. . . .

E-cigarettes Reducing 400,000 American Deaths per year to 10,000. 

Experience better health without the toxins, tar and other poisons traditional cigarettes contain. Your body will notice the relief of cutting out all of those added poisons. Our customers tell us that they feel better, their skin is better looking and they breathe better.

The Electronic Cigarette or e-cigarette, is a patented sophisticated electronic device that atomizes purified liquid nicotine and produces a vapor that, when inhaled, satisfies a smoker's craving for nicotine . . . .

When using the E-cigarette, drawing on it produces the physiological effect that a smoker seeks . . . ."

These are perfect examples of what are therapeutic claims. Here, the company is claiming that the product will treat nicotine dependence, wean smokers off nicotine (i.e., treat nicotine addiction), reduce deaths, satisfy the physiologic need for nicotine, and affect the physiological function of the body. Both structure/function and disease claims are being made here.

This warning letter, therefore, is legitimate and is a proper interpretation of the FDCA. The question is: Why isn't the agency consistent in its interpretation of the Act? Why is it lumping together claims that are therapeutic claims with those which are not because they represent neither structure/function nor disease claims?

The rest of the story is that it is not clear to me that the FDA is using a consistent and proper interpretation of the FDCA definition of therapeutic claims with respect to statements being made by electronic cigarette companies. And as I discussed yesterday, the FDA now wants to codify this misinterpretation into a formal rule.

FDA's Proposed Rule on Allowable E-Cigarette Claims Runs Afoul of Both the Constitution and the Law

Last week, the FDA gave notice of its intent to promulgate a rule that clarifies the classification of e-cigarettes as either drugs or recreational tobacco products based on certain claims made by the seller. The rule also explains the type of claims that would deem an electronic cigarette brand to be a modified risk tobacco product.

Based on my analysis of the proposed rule, I believe that it runs afoul of both the Constitution and federal law. Moreover, promulgation of this rule would increase the popularity of electronic cigarettes among youth and make it harder to promote these products for harm reduction purposes that would substantially improve the public's health. Thus, I believe that the proposed regulation is not only unlawful, but that it is not in the best interests of the public's health.

The Rest of the Story

Let's start with the aspect of the proposed rule that I believe is unconstitutional, since that is simpler than the aspect which I believe runs afoul of federal law, which is more complicated.

Why the Proposed Rule Violates the Constitutional Rights of the E-Cigarette Companies

The proposed rule violates the free speech (First Amendment) rights of electronic cigarette companies by prohibiting them from making factual claims about their products that provide critical information needed by consumers and in a way that advances no legitimate government interest. Specifically, by applying the modified risk tobacco product provisions of the Family Smoking Prevention and Tobacco Control Act to electronic cigarettes, the FDA would thereby be prohibiting e-cigarette sellers from truthfully informing their consumers that electronic cigarettes:

1. contain no tobacco; and
2. are safer than cigarettes.

The first piece of information (e-cigarettes contain no tobacco) would be prohibited (without prior FDA approval) because the proposed rule defines as a modified risk claim one which states or implies that: "the tobacco product or its smoke does not contain or is free of a substance." Thus, any implication that e-cigarettes are free of tobacco (which is obviously a substance) would constitute a modified risk claim under the proposed rule. (Note: companies could inform consumers that e-cigarettes do not produce smoke because of an exception under section 911(b)(2)(C) of the Act.)

The second piece of information (e-cigarettes are safer than cigarettes) would be prohibited (without pre-approval from FDA) because the proposed rule defines as a modified risk claim one which states or implies that: "The tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products." Thus, any implication that e-cigarettes are safer than tobacco cigarettes would constitute a modified risk claim under the proposed rule.

In general, the courts have looked negatively upon attempts by the government to prevent corporate speech that provides purely factual information and is not misleading. In such situations, the courts are almost certain to apply the Central Hudson standards, which require that the regulation advances a significant government interest.

To be sure, the claims that e-cigarettes contain no tobacco and are safer than cigarettes are truthful. Moreover, they are not at all misleading. If anything, failing to inform consumers that electronic cigarettes are not "tobacco" products and that they are safer than cigarettes is extremely misleading to the public. We know this for sure because in the absence of such claims, an extraordinarily high proportion of the public believes that cigarette smoking is no more dangerous than vaping. This has created a dangerous situation that is undermining the protection of the public's health.

There is no substantial government interest in preventing companies from hiding from consumers truthful information that does not mislead and which is absolutely critical to their understanding of the comparative benefits of the product. Prohibiting cigarette companies from falsely implying, through the use of terms such as "light" or "mild," that certain cigarette brands are safer than others does advance a legitimate government interest because it prevents the public from being misled into thinking - incorrectly - that light cigarettes are safer than non-lights. Such a prohibition would certainly pass constitutional muster under the four prongs of the Central Hudson test.

In contrast, because electronic cigarettes truly are much safer than cigarettes and because they truly do not contain tobacco (which explains why they are much safer), prohibiting electronic cigarette companies from making such claims cannot possibly be intended or necessary to prevent misleading consumers in any way. The proposed prohibition serves no legitimate public health purpose and clearly would not get by even the second prong of Central Hudson.

The FDA's application of section 911 of the Tobacco Act to e-cigarettes would almost certainly be challenged by the e-cigarette industry, and I don't see any way in which those provisions, as applied to e-cigarettes, have any chance of passing the Central Hudson test. This would be a clear violation of the free speech rights of the e-cigarette companies.

In effect, this regulation would force companies to hide critical information from their customers, which is essentially forcing them to lie to their customers for no legitimate reason. Moreover, it would result in damaging public confusion about the relative safety of smoking compared to the use of a non-combusted, non-tobacco-containing product. This does not advance a public health purpose; it actually impedes the protection of the public's health.

Why the Proposed Rule Runs Afoul of Federal Law

The proposed rule would prohibit e-cigarette companies from informing consumers that e-cigarettes may be effective in helping smokers quit. According to the rule, smoking cessation claims imply a therapeutic effect of a product and thus result in the product being classified as a drug or device (or drug-device combination) rather than as a tobacco product. This would, of course, force such an e-cigarette off the market, as it would be prohibitively costly and time-consuming for a company to fund and conduct all the clinical trials necessary to get an e-cigarette approved as a drug.

However, I believe that the FDA is misinterpreting the Food, Drug, and Cosmetic Act (FDCA) because under FDCA, to be a drug claim a communication must either: (1) claim (or imply an intention) to prevent, cure, mitigate, or treat a disease; or (2) claim (or imply an intention) to affect the structure or function of the body.

Smoking is not a disease. It is simply a behavior. Nicotine dependence, in contrast, is classified as a "disease" (under the DSM manual). A claim that a product will change one's behavior is therefore not a drug claim, unless it states or implies that such a change will prevent, cure, mitigate, or treat a disease or states or implies that it will treat nicotine dependence (i.e., wean someone off nicotine by preventing nicotine withdrawal symptoms). Thus, the pure claim that e-cigarettes may help smokers quit - in the absence of any assertion that this will prevent disease or treat nicotine dependence - cannot be properly interpreted as a drug claim under the FDCA. (For a detailed treatment of this argument, see my previous commentary).

The reason why nicotine replacement products are properly classified as drugs is that they are intended specifically to treat nicotine dependence. They deliver nicotine with the sole purpose of preventing nicotine withdrawal symptoms and thus, helping a smoker get off of nicotine. There is no long-term intention for the smoker to continue using the nicotine replacement product beyond the act of quitting smoking. In fact, the FDA does not approve the use of these drugs as alternatives to cigarettes.

In contrast, electronic cigarettes are not intended purely for use in quitting smoking. The clear intention of these products is to replace smoking. In other words, the manufacturer truly desires that the customers will replace cigarettes with e-cigarettes, not that they will quit smoking and then immediately stop using e-cigarettes as well. In fact, the clear economic incentive is for these companies to get smokers to switch to e-cigarettes and then stay on e-cigarettes long-term. It is not in their interests for smokers to quit smoking via e-cigarettes and then stop using the e-cigarettes as well. Thus, there is no inherent intention to treat nicotine dependence. In fact, the entire strategy is the opposite. A person switches to e-cigarettes, which amounts to quitting smoking, but they remain dependent on nicotine.

So far as I am aware, no electronic cigarette company advises consumers to stop using e-cigarettes after a certain amount of time. The clear intention is to replace smoking. In other words, e-cigarettes are not properly considered drugs. Instead, they are recreational alternatives to smoking. They are an alternative form of nicotine delivery. The effect they have on quitting smoking is simply an inherent consequence of completely substituting e-cigarettes for cigarettes.

The FDA misinterprets the law because it automatically deems a smoking cessation claim to imply therapeutic intent. The FDA writes:

"Products made or derived from tobacco have historically been regulated as medical products when they are marketed for intended uses that fall within the disease prong. For example, FDA has approved a number of drug products made or derived from tobacco as nicotine replacement therapies with indications to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. Accordingly, FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction and its symptoms to be within FDA’s “disease prong” jurisdiction." ...

"As discussed previously, claims related to smoking cessation have long been recognized as claims conferring drug or device jurisdiction. Smoking cessation claims have also long been associated with curing or treating nicotine addiction and its symptoms. For example, the approved labeling for nicotine replacement therapies includes the following statements: “Purpose: Stop smoking aid; Use: reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.” Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of therapeutic benefit to the user that generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose."

In writing that "claims related to smoking cessation have long been recognized as claims conferring drug or device jurisdiction," the FDA fails to explain that the reason why such claims have generally been recognized as conferring drug jurisdiction is that they state or imply an intent or effect of treating nicotine dependence by reducing nicotine withdrawal symptoms. As the FDA admits within the same paragraph, the approved labeling for NRT specifically states that the product is intended to "reduce withdrawal symptoms."

But the FDA misspeaks when it then states that smoking cessation claims have also long been associated with curing or treating nicotine addiction and its symptoms. No, cessation claims have not also been associated with treating addiction, they are drug claims because they are associated with treating addiction.

In contrast, as anti-smoking advocates are quick to acknowledge, electronic cigarettes do not treat addiction. They actually maintain addiction. Or at least that is their primary intent. They maintain addiction by providing an alternative to smoking. This is not a therapeutic intention, absent a specific claim or expressed intent to treat nicotine dependence or addiction or to prevent disease.

The effect of this rule would be to force e-cigarette companies to promote their products based on benefits that do not correspond to the primary intended use of the product. This completely contravenes the legislative intent of the Food, Drug, and Cosmetic Act. The purpose of the Act is to make sure that drugs are safe and effective, not to require that drug manufacturers hide the primary intended use of their products.

Moreover, by preventing companies from being truthful about the primary intended use of e-cigarettes, this rule would encourage (and serve as a de facto requirement) that companies promote their products in other ways, such as advertising them as being sexy, youthful, or glamorous or as being primarily intended for use in places where smoking is not allowed. This would have a negative effect on the public's health because it would make e-cigarettes more attractive to youth. In contrast, if e-cigarette companies were allowed to be truthful about the purpose of their products, the resulting advertising would lose its youth appeal (especially to nonsmokers).

Therefore, both of these proposed rules are not only without legal merit, but both are detrimental to the public's health.