Vapor Industry Fights Back

We all knew this day was coming.  The vapor industry was not going to sit back and let the FDA’s unreasonable regulations stand without a fight.  A number of industry groups have banded together and officially filed a lawsuit in the District of Columbia. The filing outlines eight counts pointing out where the FDA has […]

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Vaping: A Former Healthcare Worker’s View

The following is a guest post contributed by Helen.  All opinions are solely those of the author.   Using E-Cigarettes Could Save Your Life Smoking is one of the biggest global health threats of all time. Of the one billion people worldwide who smoke, half will die early as a result of their smoking unless they make […]

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Switching to Vaping Improves Health of Smokers with COPD

A new study by Dr. Riccardo Polosa and colleagues, published in the journal Respiratory Research, finds that smokers with chronic obstructive pulmonary disease (COPD) who switch to electronic cigarettes experience an improvement in their symptoms and have fewer COPD exacerbations.

(See: Polosa R, et al. Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respiratory Research. Published online on December 16, 2016. DOI: 10.1186/s12931-016-0481-x.)

An improvement in respiratory symptoms was observed both in smokers who switched completely to electronic cigarettes and in dual users, although those who switched completely experienced a more substantial improvement.

Although the sample size was small (24 patients in each group), the authors conclude that: “These findings suggest that ECs use may aid smokers with COPD reduce their cigarette consumption or remain abstinent, which results in marked improvements in annual exacerbation rate as well as subjective and objective COPD outcomes.”

The Rest of the Story

This study adds to the evidence that electronic cigarettes can play a significant role in achieving harm reduction among smokers who are unable to quit using traditional methods. Why anti-tobacco groups and many health agencies are discouraging smokers from using e-cigarettes to quit smoking is baffling. Ironically, the tobacco companies are encouraging smokers to quit using e-cigarettes, but the health groups apparently don’t want to see that happen. There is something very wrong in the modern practice of tobacco control.

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Swedish Match gets trapped in the FDA’s regulatory house of mirrors

For two and a half years, the FDA’s Center for Tobacco Products (CTP) has mulled over a Modified Risk Tobacco Product (MRTP) application submitted by snus maker Swedish Match. The 130,000-page application seeks to bring snus warning labels more in line with scientific reality. On December 14th, the agency finally issued a partial ruling in which one of the requests was denied and two others were deferred. Unfortunately, Swedish Match was laboring under the mistaken impression that a mountain of overwhelming scientific evidence would make a difference at the FDA.

Swedish Match requested to drop two versions of the required warning labels that have virtually zero epidemiological support: “This product can cause gum disease and tooth loss,” and “This product can cause mouth cancer.” They also requested to replace the misleading warning that, “This product is not a safe alternative to cigarettes,” with the more accurate, “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

Request to drop the gum disease and tooth loss warning: Denied

Anti-tobacco activists began making the claim that smokeless tobacco use led to tooth loss and gum disease in the 1980s. At that time, touting the risk of oral cancer wasn’t carrying enough water. Since then, the evidence supporting their claim has been weak or qualified as “suggestive.” That is, there may be an association between smokeless tobacco and poor dental health, but solid evidence hasn’t been found. In denying the request, the FDA stated that if they were to drop the tooth loss warning it would be tantamount to claiming that snus cannot cause gum disease and tooth loss, and Swedish Match failed to substantiate this claim. That’s right. Swedish Match was denied because they were unable to prove a negative. In science, this is known as a fallacy. At the FDA, it’s justification for keeping a warning label about something that might happen to someone, no matter how rare or unconvincing the evidence is for it.

Request to drop the oral cancer warning: Deferred

By opting to defer, the FDA is giving Swedish Match the opportunity to amend their application and resubmit. But, the FDA is asking for the impossible. On the question of oral cancer risk, just like the denial of the tooth loss warning, Swedish Match has to submit evidence supporting the claim that snus cannot cause oral cancer. It matters not that decades of epidemiological evidence has found no solid link between snus and oral cancer. Swedish Match has to beat the infinite bushes and produce evidence that it cannot ever happen. The FDA has turned the burden of proof concept on its head. The FDA does not have to show cause and present convincing evidence that the warning labels are truthful. Swedish Match, on the other hand, must show that the warning labels are 100% false and do it far more convincingly than the FDA.

Request to drop the “not a safe alternative” warning: Deferred

On the question whether snus poses substantially less risk than smoking, the FDA adopts a standard that is as ill-defined as it is convoluted (See page 10 of 115 here). Swedish Match has to show “that the modified risk information would be comprehended by the public in the context of total health and in relation to all tobacco-related diseases, particularly in the context of a warning.”  If you know what this means, you’re probably one up on the FDA.  Apparently, the basic and truthful statement “substantially lower risks to health than cigarettes” is potentially misleading without putting the statement into the context of “total health” and “in relation to all tobacco-related diseases.” The job of Swedish Match is to provide evidence showing that the public will comprehend the proposed warning in precisely this way. If, as a researcher, you fail to see how you could possibly demonstrate this with a single declarative statement, then welcome to the deliberately vague requirements of the MRTP application process. Swedish Match must feel like Doyle Lonnegan at the end of “The Sting” when he realizes he’s been conned out of half a million dollars.

Without relitigating Swedish Match’s request, it should suffice to say that each of the label changes is indeed backed by decades of research–both in Sweden and the United States. The data clearly shows that exclusive snus users do not experience health problems (including oral cancer, gum disease, and tooth loss) in significantly greater numbers than non-users. (Professor Brad Rodu discusses this in more detail here.) By way of contrast, similar research undeniably shows that cigarette smokers are prone to a litany of health problems compared to non-smokers. These two basic findings are all one needs to confidently conclude that snus “presents substantially lower risk” than smoking.  It’s as close as it gets to a no-brainer in science.

The FDA’s prohibitionist agenda: Confirmed

Harm reduction experts have long given up trying to figure out how the FDA might rule when it comes to tobacco products. It’s often not clear that the FDA itself knows what it’s thinking. But, the FDA CTP’s public statements, tweets, and advertising campaigns make one thing abundantly clear: they are fervently anti-tobacco in all the flavors and styles this form of extremism can take.

The FDA is on a mission to convince the public that all use of tobacco, regardless of form, is destructive and has no redeeming value; they don’t want anyone to use it; everything that can be done to dissuade people from using it must be done; and, most certainly, no one should get the impression that it might be acceptable to use tobacco–even though tobacco use clearly has benefits for many people. For decades, people in tobacco control and public health–the same people who now control the FDA’s CTP–have been hammering into the American psyche that all forms of tobacco are equally bad and should be avoided at all costs. This is the simple, handy, consistent fiction at the core of their messaging. They themselves may actually believe it’s true having repeated it so often over the years.

The FDA has very little motivation to revisit justifications for the oral cancer warning. After all, nothing scares people more than the specter of cancer. If they lose this warning they’ll have one less cudgel to use on smokeless tobacco users in the effort to convince them to quit. Never mind that it isn’t true. The goal of the prohibitionist mindset at the FDA is to coerce people into not using tobacco and nicotine. The availability of other forms of tobacco that deliver nicotine with very little risk, a risk people are free to assume because they enjoy it and the benefits it provides, simply doesn’t matter.

The warning label proposed by Swedish Match, that snus is significantly less risky than smoking, aims directly at the house-of-cards foundation of the tobacco control endgame (read: prohibition). If the obviously truthful warning that snus is less harmful than smoking is approved and sees the light of day, then their plan for a tobacco-free world begins to crumble:

  • First, for decades, a public-health article of faith claims that smokeless tobacco is just as risky to health as smoking.  Approving the proposed label is an admission that this dogma is embarrassingly wrong.
  • Second, learning that some forms of tobacco pose much less health risk will encourage more people to try these products. The FDA wants fewer people using tobacco products, not more.
  • Third, smokers may not quit all tobacco products, as they’ve been instructed. Instead, they might switch to snus, be happy with it, and feel no need to quit tobacco use at all.
  • Fourth, youth considering experimenting with tobacco, but who may be deterred by the risk claims, might see the new snus warning as a green light.  

According to the FDA’s public health worldview, any one of these outcomes would be a disaster. It’s no wonder the FDA is pretending to straddle the fence on the Swedish Match application. There’s too much at stake for their credibility, their ability to manipulate people into correct behavior, and serve their blinkered goal of eventually having no one use tobacco.

Somewhere in America today, there are smokers who are concerned about their health and may be contemplating switching to snus. They might make a serious effort to switch if it weren’t for the FDA and others cultivating the lie that they are merely trading lung cancer for oral cancer. However, if they saw the new, more accurate warning they might be persuaded to give it a try. Instead, they don’t buy that tin of snus and maintain their status quo by purchasing a pack of cigarettes. When you attempt to trick people into healthier behavior by allowing false and misleading warning labels to stand, you’re not protecting them. No. You are pushing them toward a poor, uninformed decision that leads to an early grave: To continue smoking instead of switching to far less risky snus.

Dr. Brian Carter

CASAA Director of Scientific Communications

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Finalists Announced for 2016 Lie of the Year Award

Today, I am announcing the finalists for the 2016 Lie of the Year Award. This award will be given to the health agency or organization which has lied most egregiously to the public about smoking and/or vaping in 2016. Feel free to cast your ballot in the comment section. Readers’ votes will be taken into consideration in making the final determination. The award consists of a $100 donation to the American Vaping Association and Consumer Advocates for Smoke-Free Alternatives Association ($50 each) made in the name of the winning organization.

The 2016 finalists are:

1. American Thoracic Society

Claim: E-cigarettes are not safer than conventional cigarettes.

The Truth: E-cigarettes are much safer than conventional cigarettes.

Details: In a press release issued in April 2016, the American Thoracic Society stated as follows:

“Frank Leone, MD, chair of the ATS Tobacco Action Committee, believes the misconception that e-cigarettes are safer than traditional cigarettes is driving the trend to increased use, which puts children and other first-time users at risk for significant health problems.”
2. University of Louisville

Claim: E-cigarettes are not safer than conventional cigarettes.

The Truth: E-cigarettes are much safer than conventional cigarettes.

Details: In a July 2016 paper published in the journal Current Cardiovascular Risk Reports, Dr. Aruni Bhatnagar of the University of Louisville concluded that:

“The dose-response relationship between smoking and cardiovascular mortality is non-linear, suggesting that reduction in HPHC concentrations in e-cigarette aerosols may not result in proportional harm reduction and decreased HPHC exposure may be offset by increased use by individuals who believe that e-cigarettes are safer than conventional cigarettes. Thus, taken together, current evidence does not entirely support the notion that e-cigarettes are reduced harm products… .”

3. Johns Hopkins All Children’s Hospital

Claim: Vaping is just as dangerous as smoking.

The Truth: Vaping is much safer than smoking.

Details: In an August 2016 web site article, Dr. Rachel Dawkins of the Johns Hopkins All Children’s Hospital was quoted as stating:

“Most importantly, parents should talk to their children about the dangers and harmful side effects of e-cigarettes and others drugs. Parents should also consider vaping just as dangerous as smoking cigarettes when talking to their teens about the dangers of tobacco use and smoking.”

4. Arizona Department of Health Services

Claim: Vaping is as dangerous as smoking.

The Truth: Vaping is much safer than smoking.

Details: On its web site in October 2016, the director of the Arizona Department of Health Services stated:

“We did research this year with several youth focus groups around the state and found there is a misconception that using a vape pen is not as dangerous as a regular cigarette. The truth is there are many of the same dangerous chemicals in a vape pen that are in a cigarette, including nicotine which is a highly addictive chemical.” 

5. Surgeon General of the United States

Claim: Vaping is a form of tobacco use.

The Truth: Vaping is not a form of tobacco use. Electronic cigarettes do not contain any tobacco.

Details: In his 2016 report, the Surgeon General stated:

“These products [e-cigarettes] are now the most commonly used form of tobacco among youth in the United States, surpassing conventional tobacco products, including cigarettes, cigars, chewing tobacco, and hookahs.” 

6. Campaign for Tobacco-Free Kids

Claim: Tobacco companies are marketing gummy bear and cotton candy e-cigarettes.

The Truth: None of the tobacco companies markets gummy bear or cotton candy e-cigarettes.
Details: In a solicitation for donations, the Campaign for Tobacco-Free Kids stated:

“These are just a few of the [tobacco] industry’s latest tricks: … Using slick ads, celebrity spokespeople, and sweet flavors like gummy bear and cotton candy to push e-cigarettes.”

7. Alaska Department of Health and Human Services

Claim: Using e-cigarettes is riskier than smoking.

The Truth: Vaping is much safer than smoking.

Details: According to a KTUU News article in January 2016, Dr. Jay Butler – the state’s chief medical officer – stated: 

“We do see more kids using e-cigarettes now than smoking, so e-cigarettes right now are the neatest, shiniest thing and they’re kind of cool so in that sense they do provide a riskier alternative to cigarettes.”

8. Centers for Disease Control and Prevention (CDC)

Claim: There was no decline in youth tobacco use between 2011 and 2015.

The Truth: There was a substantial decline in youth tobacco use between 2011 and 2015. Vaping is not a form of tobacco use, so it should not be included in the figure reported by CDC.

Details: In April 2016, the CDC issued a press release stating that there was: 

“No decline in overall youth tobacco use since 2011.”

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The Pasadena Health Department is using a $1.5 million…

The Pasadena Health Department is using a $1.5 million anti-tobacco grant from the CDC to call vapers ‘stupid sheep.’

In this video, Pasadena-area vapers, as well as Stefan Didak (NOTBlowingSmoke) and Father Jack Kearney (Board Member, California Association for Drug & Alcohol Education), explain why the campaign should never have been approved.

Dr. Michael Siegel, Professor at the Boston University School of Public Health, has called for the campaign to be pulled and for the Health Department to apologize –…

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Arizona Health Department: Vaping is as Dangerous as Smoking; When Will the Lies Stop?

According to the Arizona Department of Health Services, vaping is just as dangerous as smoking. The state health department has initiated a campaign entitled “Vape is a Lie” to teach kids about the dangers of vaping and nicotine use. The director of the state agency describes the primary purpose of the campaign as follows:

“We did research this year with several youth focus groups around the state and found there is a misconception that using a vape pen is not as dangerous as a regular cigarette. The truth is there are many of the same dangerous chemicals in a vape pen that are in a cigarette, including nicotine which is a highly addictive chemical.”

According to the Department: “Our goal with this new campaign is to give youth the truth about the potential dangers of using e-cigarettes.”

The Rest of the Story

Ironically, the rest of the story is that it is the Arizona Department of Health Services which is telling the greatest lie about vaping. It is simply not true that using a vape pen is as dangerous as smoking a real cigarette. In fact, vaping is much safer than smoking. There is abundant research which demonstrates this. But it is also common sense, as electronic cigarettes contain no tobacco and do not involve combustion. How could they be as dangerous as tobacco cigarettes, which we know kill more than 400,000 Americans each year? There is no legitimate scientific dispute over the fact that vaping is much safer than smoking.

If the goal of the new campaign is “to give youth the truth,” then it is failing miserably. Rather than providing youth with the truth, the campaign is blatantly lying to kids. Not only is it giving them false information about the relative risks of vaping vs. smoking, but it is undermining decades of public education about the severe hazards of smoking.

Why is there a need for the Arizona Department of Health Services to lie? Why isn’t the truth enough? Not only does this campaign run afoul of the public health code of conduct, of which honesty is a key principle, but the campaign also insults the intelligence of youth. It assumes that kids are so stupid that you have to lie to them. What kind of message does this send, especially to parents? Apparently, the Arizona Department of Health Services thinks that parents should lie to their kids about the hazards of vaping. This runs counter to the basic principles of public health and to the principles of risk communication.

Tim Mechling of Mt Baker Vapor breaks down the dishonesty of the Vape is a Lie campaign in a post aptly entitled “‘Vape is a Lie’ is a Lie.”

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D.C. District Court Should Issue an Immediate Injunction Against Enforcement of FDA Deeming Regulations

According to an ABC News story, a Connecticut man was injured when an electronic cigarette exploded in his mouth. The problem, according to the local Deputy Fire Marshal, is that “cheaply made aftermarket batteries can short circuit in milliseconds.” The article reports that there have been at least 92 other documented explosions.

There seems to be a simple solution to the problem. The company that manufactured the defective e-cigarette used by this Connecticut man should find a different source of batteries, instead of using the cheap aftermarket batteries that can short circuit in milliseconds.

However, there is just one problem. The FDA deeming regulations do not allow that e-cigarette company, or any of the multiple others whose batteries have exploded, to replace the cheap aftermarket batteries with safer ones. If they did so, it would constitute a new “tobacco product,” and could not be placed on the market until the company applied for and received a marketing authorization from the FDA, a process that would take years and millions of dollars. So effectively, the FDA has banned safety improvements such as replacing defective batteries.

Because of this, the FDA deeming regulations represent a clear and present danger to the health of the public. Accordingly, the D.C. District Court should issue an immediate injunction against the enforcement of the new tobacco product application provisions of the regulations, thus allowing companies to make critical safety improvements necessary to protect the health and lives of consumers.

The FDA justifies its regulations based on pure speculation about the hazards of vaping products, yet is taking no action to remedy the one documented adverse health effect of these products: the potential for exploding batteries. Not only is the FDA failing to take action about this problem, but it has made the problem much worse by prohibiting companies from fixing the problem.

In all my years in public health, I cannot think of another public health regulatory action that is so acutely threatening to the public’s health.

An alternative to a federal court injunction would be an executive action by the new president directing the FDA to immediately halt enforcement of the pre-market tobacco application requirements of the deeming regulations.

The Rest of the Story

Regardless of how anti-tobacco groups feel about the use of e-cigarettes for harm reduction in tobacco control, all should agree that sensible regulations would not block critical safety improvements to these products. The deeming regulations are nonsensical, and they need to be voided and replaced. This is something I and many others will be working on in the new year.

Ironically, the approach being advocated by anti-tobacco groups to providing safeguards against potential hazards of electronic cigarettes is doing the exact opposite. In contrast, my recommended approach – trashing the new product application process and directly promulgating safety standards – would have taken care of the exploding battery problem years ago.

The rest of the story is that the desire to just get rid of these products has overshadowed the desire to actually regulate the safety of the products and to protect public health and safety. In other words, in the tobacco control movement, ideology has overtaken science.

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