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Welcome to the blog area of our site where we hope to keep you updated on the trends of the e-cigarette industry as well as product reviews.

Vape Shop Air Sampling by California State Health Department Suggests that Secondhand Vape Exposure is Minimal

As part of its investigation into the potential health effects of electronic cigarettes, the California Department of Public Health has been conducting air sampling and personal exposure monitoring in vape shops throughout the state. The results of sampling in one of these vape shops, obtained by The Rest of the Story, reveal that "secondhand vaping" appears to result in minimal exposure of bystanders to hazardous chemicals.

In this particular vape shop, sampling was conducted under quite adverse conditions. Many of the employees vaped throughout the sampling and 13 customers vaped while in the shop. There was no active ventilation system, and visible clouds of vapor were visible at times. So this seems to represent a high level of exposure compared to what one might expect in a public place outside a vape shop (e.g., a restaurant, bar, or office workplace).

Here are the major results of the air sampling:

Nicotine: Not detected
Glycidol: Not detected
Formaldehyde: 7.2 ppb
Diacetyl: Not detected using standard method
2,3-Pentanedione: Not detected using standard method
Acetyl butyryl: Not detected using standard method
Acetoin: Not detected using standard method
Acetone: Not detected
Ethyl benzene: Not detected
m,p-Xylene: Not detected
o-Xylene: Not detected
Toluene: Not detected
Acetaldehyde: Not detected
Acetonitrile: Not detected
alpha-pinene: Not detected
Benzene: Not detected
Chloroform: Not detected
d-Limonene: Not detected
Methylene chloride: Not detected
Methyl methacrylate: Not detected
n-Hexane: Not detected
Styrene: Not detected

The level of formaldehyde detected is consistent with normal indoor and outdoor air levels of formaldehyde under baseline conditions.

Other than the small concentration of formaldehyde, the only other chemicals that were quantified were ethanol (alcohol) and isopropyl alcohol.

The Rest of the Story

This study, although conducted under very high exposure conditions in a small, non-ventilated vape shop with many employees and customers vaping and clouds of vapor visible, did not document any dangerous levels of exposure to any hazardous chemical. Nicotine exposure was essentially non-existent. Formaldehyde exposure was no different than in many indoor and outdoor environments at baseline. Acetone, acetoin, other aldehydes, toluene, benzene, and xylene were not detected. Chemicals that have been associated with "popcorn lung" were also not detected by the standard method.

This study adds to the evidence that under real-life conditions, "secondhand vaping" does not appear to pose any significant health risks.

Despite the claims of many anti-vaping organizations, the documented health risks of "secondhand vaping" appear to be minimal. And this is in an environment with relatively extreme conditions -- there was a visible cloud of vapor at times.

Based on the current scientific evidence, I fail to see the justification for banning vaping in most public places. And remember, this is coming from a guy who has devoted virtually his entire career to banning smoking in bars, restaurants, casinos, and every other indoor workplace (and even outdoor seating areas of restaurants). So I'm certainly not one to minimize the health risks of preventable environmental exposures.

However, I believe that there must be reasonable evidence before the government intervenes to ban a behavior such as smoking or vaping. With regards to vaping, I just don't see any reasonable evidence at this time that it poses any significant health hazard to bystanders.

Original author: Michael Siegel
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Lying with literally true statements is the worst kind of lying

by Carl V Phillips

...
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A Major Embarrassment for the FDA: Congressman to Introduce E-Cigarette Regulatory Bill Tomorrow

According to multiple sources, Representative Duncan Hunter (R-CA) will introduce legislation tomorrow in the House of Representatives that will create a new regulatory framework for electronic cigarettes and vaping products. The bill is titled “The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017.”

Briefly, here is what the bill would do, in order of importance:

1.     The FDA would be precluded from regulating electronic cigarettes under the same framework as tobacco cigarettes. Thus, the bill would put an end to the requirement for e-cigarette companies to submit pre-market tobacco applications and would not apply modified risk provisions to vaping products.
2.     The bill would set up a distinct regulatory framework for electronic cigarettes, under the jurisdiction of the FDA’s Center for Tobacco Products.
3.     The bill would establish safety standards for e-liquids and vaping devices that would go into effect one year after the enactment of the legislation. These standards include:
a.       Immediate adoption of the e-liquid standards developed by the American E-Liquid Manufacturing Standards Association (AEMSA);
b.       Subsequent adoption of the e-liquid standards being developed by the American National Standards Institute (ANSI) once they are established;
c.       Immediate adoption of battery safety standards set by the International Electrotechnical Commission;
d.       Immediate requirement for short-circuit protection for the heating element;
e.       Battery overcharge protection;
f.        Battery discharge protection; and
g.       Tracking of all devices by serial and lot numbers.
4.     The FDA would be required to review any subsequent e-liquid standards established by AEMSA or ANSI and adopt such standards if they are deemed to be appropriate for the protection of the public’s health.
5.     The FDA would be authorized to promulgate regulations to prevent marketing of vaping products to minors.
6.     The FDA would be required to conduct a health safety assessment comparing the risks of different tobacco products as well as vaping products and submit this report to Congress.
7.     The FDA’s Center for Tobacco Products would be renamed the “Center for Tobacco Products and Tobacco Harm Reduction.”

The Rest of the Story

This is critical and much-needed legislation that would put an end to the lunacy going on with the current regulation by the FDA of cigarettes and e-cigarettes. Right now, the FDA regulates e-cigarettes much more stringently than real cigarettes, putting an almost insurmountable obstacle in front of the development and marketing of electronic cigarettes – all to the advantage of the real, maximum harm, tobacco cigarettes. The current regulations will decimate the electronic cigarette industry, removing 99% of vaping products from the market and eliminating much of the competition faced by cigarettes for the nicotine market. This legislation would finally put an end to such nonsense.

It makes perfect sense to carve out a separate regulatory framework for electronic cigarettes that is separate from that for real cigarettes. This is something I have been calling for repeatedly during the past five years, and it is gratifying to see this potential approach finally seeing the light of day.

The most interesting aspect of this story is what an embarrassment it is for the FDA. While the FDA has had regulatory jurisdiction over electronic cigarettes for the past seven years, it has not established a single safety standard for these products. It has watched scores of people being injured by exploding batteries and done nothing. Even worse, the agency has actually prohibited companies from repairing this defective battery problem because any such change would render the product a “new tobacco product,” meaning that it could not be marketed without pre-approval – a process that would take years and is prohibitively expensive for all but the largest of companies.

Now, in one fell swoop, Representative Hunter and co-sponsors are stepping in establishing almost immediate safety standards (that go into effect in one year) that not only regulate battery safety, but also regulate all aspects of e-liquid manufacturing. This is something that the FDA could have and should have done years ago. But it has been too busy developing its prohibitory approach to e-cigarettes rather than actually working to protect the public’s health by assuring the maximum safety of e-cigarettes being used by millions of Americans.

This bill is not perfect, but it is a superb start and with a couple of amendments could be ideal. Here are the two major changes that I believe are necessary:
1.     The FDA should be given authority to set additional safety standards, beyond the e-liquid standards established by AEMSA and ANSI and the battery standards outlined in the bill. This is critical because we don’t know what safety features will be uncovered as research into e-cigarette safety continues and evolves. The FDA needs the flexibility to establish additional safety standards as they are warranted.
2.     The statute should explicitly address what claims are allowed and disallowed in e-cigarette marketing; in particular, what claims represent therapeutic claims and what claims are allowable without making a product subject to regulation as a drug or device. Specifically, I would like to see language that allows companies to truthfully inform their consumers that vaping is much safer than smoking and that it can be effective in helping many smokers to quit. Neither of these should be considered to be drug claims and should be allowed as long as they are accurate.

Please note that this commentary pertains to the merits of the legislation. I am not commenting on the political strategy, the wisdom of introducing this bill at the same time as the Cole-Bishop rider is considered, or other political concerns. I defer to others who know more about the political climate than I do.

But from purely a public health policy perspective, this legislation makes sense. It needs to be strengthened by allowing the FDA to set additional safety standards and by explicitly allowing reduced risk and smoking cessation claims. However, it is a great start to correcting the lunacy of today's federal regulation of electronic cigarettes.
Original author: Michael Siegel
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Smokeless Tobacco 101



Huffington Post has published a discussion Joel Nitzkin and I had with psychotherapist Robi Ludwig (here).  HuffPo was not able to use the large number of resource links we provided, so I am republishing the article with the full complement, below.

Two Doctors on A Mission to Set the Record Straight about Smokeless Tobacco and Its Impact on Public Safety


The historical roots of tobacco go way back to almost the beginning of time. Some date it as early as 1 B.C. when the American Indians used it for religious and medicinal practices. Given what we know about tobacco today it’s almost impossible to believe tobacco was ever thought of as a cure-all for everything from dressing wounds to the standard go-to painkiller.

By the 1600’s tobacco was so popular that it was even used almost as frequently as money. Some even referred to it “as good as gold”.

But some of the dangerous effects of smoking tobacco was starting to become apparent during this time, too. Sir Francis Bacon, the 1st Viscount St Alban, an English philosopher, statesman, scientist, jurist, orator, and author, who served both as Attorney General and as Lord Chancellor of England, admitted to having a very hard time quitting his tobacco use and found it to be an impossible “bad” habit to break.

When we fast forward historically to the 1960’s, this is when the Surgeon General reported the various dangers of smoking to our health. And by 1971 Commercial Ads for cigarettes were taken off the air in the United States as an attempt to curb this dangerous and growing habit.

Even today, with everything we know about the dangers of smoking, there are still some misperceptions out there about tobacco use, which could negatively impact up to 8 million adult American Smokers, but not if two prominent doctors have their way.

Now Dr. Rodu and Dr. Nitzkin are trying to influence the public about Tobacco use by setting the record straight. Dr. Brad Rodu, who has studied the science behind tobacco harm-reduction strategies and has been appointed the first holder of the endowed chair in tobacco harm reduction research at the University’s James Graham Brown Cancer Center and Dr. Joel Nitzkin, public health physician, who is board certified in preventive medicine and has been involved in tobacco control activities since the late 1970’s, have made it their professional mission to reduce tobacco-related illnesses.

Dr. Rodu and Dr. Nitzkin strongly believe that smokers who are unable or unwilling to quit cold turkey should be informed about much lower risk smokeless tobacco or e-cigarettes. I spoke with both doctors to find out how they believe adult smokers can potentially be spared from life-threatening smoking-related illnesses. Here’s more about what they both had to say on this topic.


Dr. Robi: What exactly is smokeless tobacco, why was it created?

Dr. Rodu and Dr. Nitzkin: Anthropologists and historians believe that tobacco has been used by humans for thousands of years.  The plant originated in the New World and was completely unknown outside the Americas until 1492, when Columbus first encountered native Americans using tobacco for ceremonial and medicinal purposes.  They smoked and chewed tobacco, the latter serving as the provenance of modern smokeless tobacco products.

Smokeless tobacco dominated the American market prior to the 20th Century, because a day’s supply could be carried and conveniently used in both industrial and agricultural work settings.  In contrast, smoking was uncommon because producing cigars, cigarettes and pipes was labor-intensive and expensive.  In addition, smoking was very inconvenient before a safe and portable source of fire was readily available, which didn’t happen until the widespread use of safety matches in the late 1800s.  


Dr. Robi: What are the different kinds of smokeless tobacco?

Dr. Rodu and Dr. Nitzkin: In the U.S. there are two main kinds of smokeless tobacco.  Loose leaf chewing tobacco (“chew”) consists of shredded tobacco leaves and stems packaged in foil pouches.  Chew is also heavily sweetened and flavored.  It is used in fairly large quantities, which produces the typical swollen cheek appearance and generates a lot of juice.

Moist snuff, also called dip tobacco, is the most popular smokeless product in the U.S.  It is manufactured from dark, fire-cured tobaccos grown in western Kentucky and Tennessee, fermented and ground to the consistency of finely chopped parsley.  Multiple flavors are available, but moist snuff does not contain sweeteners.  It is used in small amounts, generally as much as can be grasped between the thumb and forefinger in a “pinch.”  The tobacco is then placed inside the lower lip between the cheek and gum.

Moist snuff is hard to contain in one spot, so manufacturers have packaged pinch-sized portions in small tea-bag type paper pouches.  The pouches are no larger than a piece of chewing gum or a breath mint, making them virtually invisible to place and use.  They also don't disintegrate, which makes the tobacco easy to remove after use.

Since 2005 a Swedish version of moist snuff, called snus, has become more popular in the U.S.  Rather than fermented, the tobacco is treated by a pasteurization process that gives it a different flavor than American dip, and somewhat lower levels of unwanted contaminants.  Snus is also marketed in many flavors and small pouches.

Americans place moist snuff in the lower lip, where it generates juice and spitting.  In contrast, Swedes don’t have to spit when they use snus, mainly because they place it inside the upper lip.

Nicotine is absorbed from all smokeless tobacco products through the lining of the mouth, giving the user a “buzz” very similar to, but with a slower onset than that achieved by smoking a cigarette.  Nicotine is not the major cause of any disease; it is no more harmful than caffeine, which is also addictive but safely consumed in coffee, tea and cola drinks.   


Dr. Robi: Are different kinds of smokeless tobacco better for you than others?

Dr. Rodu and Dr. Nitzkin: No tobacco product is absolutely safe.  All contain traces of unwanted contaminants in addition to nicotine.  But it’s been known for two decades that, by avoiding smoke, chewers, dippers and snusers eliminate about 98% of the health risks associated with smoking.  The risks are so small that even large epidemiologic studies with hundreds of thousands of users cannot provide indisputable evidence that smokeless tobacco causes any disease. 

With risks that small, it is not possible to prove that one kind of dip, chew or snus is safer than the other.


Dr. Robi: Why is there so much confusion about smokeless tobacco and if this is a healthy alternative to regular cigarettes?

Dr. Rodu and Dr. Nitzkin: Decades of scientific studies document that smokeless tobacco use is vastly safer than smoking with respect to cancer, heart attacks and strokes and many other diseases.  There is no confusion about smokeless tobacco among tobacco research and policy experts.  In 2002 a report by the British Royal College of Physicians, one of the world’s oldest and most prestigious medical societies, stated “As a way of using nicotine, the consumption of non-combustible [smokeless] tobacco is on the order of 10-1,000 times less hazardous than smoking, depending on the product.”  The Royal College issued another report in 2007 concluding “…that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.  In 2008 the American Association of Public Health Physicians became the first medical organization in the U.S. to formally adopt a policy of “…encouraging and enabling smokers to reduce their risk of tobacco-related illness and death by switching to less hazardous smokeless tobacco products.”   

Cigarettes are so popular that tobacco controllers incorrectly use the terms “smoking” and “tobacco use” as if they were synonyms, and they have become obsessed with the notion of a tobacco-free society.  They have transformed a legitimate war on smoking into a moral crusade against all tobacco products, a mistake that was tragically made with alcohol almost 100 years ago.

When a federal survey asked in 2015 if smokeless tobacco products are less hazardous than cigarettes, only 11% correctly answered “yes”; 67% responded “no” and 22% didn’t know.  In other words, 89% of Americans have no clue that dipping, chewing and snusing are 98% safer than smoking.  They are confused because they have been misinformed for decades by government agencies and medical organizations that all tobacco products are equally harmful. 

Misinformation from public health officials should no longer be tolerated.  Recently, two internationally renowned tobacco policy experts, Lynn Kozlowski, professor at the University of Buffalo School of Public Health and Health Professions, and David Sweanor, adjunct professor of law at the University of Ottawa, urged the FDA to end a $36 million campaign against smokeless tobacco “that fails to directly warn about the much greater harms from smoked tobacco (predominantly cigarettes).”  They concluded that “Public health agencies have an obligation to correct the current dramatic level of consumer misinformation on relative risks that they have fostered.” 


Dr. Robi: Why do you think the FDA has not informed the public about the whole truth about smokeless tobacco?

Dr. Rodu and Dr. Nitzkin: Obsessed with the notion of a tobacco-free society, the FDA so far has taken a hard line, falsely claiming that “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.”  In other words, no tobacco product is absolutely safe.  The agency is defying a key element of its stated mission – “to provide the American public with factual and accurate information about tobacco products.”  And Congress in 2009 prohibited tobacco companies from any communication with smokers regarding safer smokeless alternatives without the express approval of the FDA. 

The FDA has refused to acknowledge that its smokeless warnings are inaccurate.  Even worse, some of its regulations threaten to remove large numbers of smokeless and vapor products from the market.  In some cases the regulations require companies to conduct dozens of unnecessary studies on minute product details and human effects, which could take a decade or more.

This is regulatory fundamentalism, a bureaucratic maze that condemns smokeless tobacco products and e-cigarettes, and therefore tobacco harm reduction, to purgatory. With this delay, cigarettes will continue to dominate the American tobacco market, and 440,000 Americans will die from smoking-related disease every year.


Dr. Robi: How many adult smokers use smokeless tobacco as a way to quit smoking altogether?

Dr. Rodu and Dr. Nitzkin: Federal surveys are usually used to count current, former and never tobacco users.  The surveys generally don’t ask former smokers if they switched, but there was one exception.  In 2000, the National Health Interview Survey asked former smokers if they had quit by switching to smokeless; some 260,000 men said yes, providing the first population-level evidence that smokeless is a viable cigarette substitute. 

The 2015 NHIS documented that there were 5.1 million current smokeless tobacco users that year.  Unfortunately, the survey didn’t ask former smokers specifically about switching, but about 1.6 million smokeless users were former smokers, meaning they had switched to safer products like dip, chew or snus.  Almost 1.4 million smokeless users were current smokers; if they were made aware that smokeless was 98% safer, they might have fully switched.


Dr. Robi: How many smokers die every year from smoking cigarettes? How about from smokeless tobacco?

Dr. Rodu and Dr. Nitzkin: According to the CDC, the annual death toll among smokers is 440,000.  Despite the fact that smoking rates have been plummeting for three decades, the CDC death toll hasn’t changed for nearly 20 years.  In 2013, an FDA scientist concluded that the CDC estimate is too high.

One might assume that the CDC tracks smoking deaths throughout the year, but that’s not the case.  Instead, they estimate the number of smokers in the U.S., then they apply secret mathematical formulas based on comparisons between current, former and never smokers.  A reporter years ago tried unsuccessfully to crack the black-box formulas.  Here is her summary: “The computer is fed raw data and... employs various complex  mathematical  formulas  to  determine  how  many people in various age groups, locations, and heaven knows what other categories are likely to get sick or die from what diseases and how many of these can be assumed to be smoking related.”

The CDC provides death counts among smokers with single-digit precision (the current number is 439,033), but when it comes to deaths from smokeless use, the agency claims it can’t be done.  In fact, the CDC has the necessary data; its disinclination is likely due to the very low number that would result.  British researchers are not so inhibited; they reported in 2015 that there were no cancer deaths due to smokeless tobacco in the U.S. and Canada.  Last year, U.S. government-sponsored research revealed that the number of mouth cancer deaths among men who use dip or chew is zero.        


Dr. Robi: What is the “Swedish Experience” and how does it connect to tobacco harm reduction?

Dr. Rodu and Dr. Nitzkin: In virtually all developed countries, cigarette smoking has been the dominant form of tobacco consumption for over 100 years.  Sweden is a remarkable exception.  Smoking rates among men in Sweden have always been lower than in any other developed country, resulting in the lowest rates of lung cancer – indeed, of all smoking-related deaths.  The reason is that, instead of smoking, Swedes enjoy nicotine and tobacco by using snus, a 200-year old smokeless product.

A study published in the Scandinavian Journal of Public Health examined lung cancer – the sentinel disease of smoking – among men and women in all European Union countries.  It concluded “that snus use is inversely correlated with cigarette consumption among men in Sweden, resulting in the lowest [lung cancer mortality rates] in Europe for most of the past 50 years.” 

Numerous published studies have documented that male smokers in Sweden have used snus as a gateway to a smoke-free life, but that is only part of the story.  Snus use has also played a valuable role in steering tobacco initiators away from cigarettes.  Any tobacco use among children should be discouraged, but Swedish boys who experiment with tobacco choose snus, the product their fathers use.  This fact is well-received by tobacco research and policy experts who focus on eliminating deaths from smoking, not on eliminating tobacco.

With respect to tobacco, Sweden is unique in the 28-country EU, which bans snus everywhere else.  The effect of this prohibition is profound.  If men in all EU countries had the smoking rate of Swedish men, nearly 300,000 deaths from smoking could be avoided each year.    

The Swedish experience also has implications for its neighbors Norway and Finland.  In 1995, when Sweden and Finland joined the EU, Sweden applied for and received a waiver on the EU’s existing snus prohibition, thereby allowing Swedes to continue producing and selling within the country.  Finland adopted the ban, and since Norway never joined the EU, snus remained available there.

Norwegian tobacco research experts have documented that snus suppressed smoking rates there.  In Finland, the decline in smoking levelled off after the 1995 snus ban, while the decline in Sweden continued.

The Swedish experience wasn’t launched as a government program or anti-tobacco campaign.  It arose organically as tobacco users in Sweden made rational choices to use snus instead of cigarettes. 


Dr. Robi: If you had to state a clear message to the public about smokeless tobacco, what would it be?

Dr. Rodu and Dr. Nitzkin: The Swedish experience exemplifies harm reduction: consumers making rational choices to use smokeless instead of cigarettes, based on accurate perceptions and preferences.  The 40-50 million Americans who consume tobacco deserve truthful information from government and health organizations about vastly safer smokeless tobacco, e-cigarettes and vapor.  Millions of them could make the switch from combustible to smoke-free and lead longer and healthier lives.  How Swede it could be.   





Original author: Brad Rodu
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New Article on Graphic Warning Labels is Wrong on the Law: Why Strict Scrutiny is the Proper Standard for Proposed FDA Warnings

In 2011, the Food and Drug Administration (FDA) issued regulations that required graphic warning labels on cigarette packages. The FDA chose nine graphic images, such as a picture of a man with a chest scar from cardiac surgery, along with a telephone number for smokers to call for help with smoking cessation (1-800-QUIT-NOW). The tobacco companies subsequently challenged the rule, arguing that it violated their First Amendment rights by compelling them to commercial speech which is against their economic interests (i.e., speech which strongly encourages consumers to stop using the product). The D.C. district court overturned the regulations on this basis, a decision that was affirmed by the appellate court.

One of the issues in the case was whether the required warning labels represent merely factual and uncontroversial information or whether they are intended to elicit an emotional response that goes beyond merely the provision of factual information. In an apparent attempt to defend the regulations, new research published in the journal Tobacco Control reports the results of a study showing that graphic images can be informative and textual messages can evoke emotion, thus (supposedly) invalidating the court's reasoning in rejecting the rule.

(See: Popova L, et al. Factual text and emotional pictures: overcoming a false dichotomy of cigarette warning labels. Tobacco Control 2017; http://dx.doi.org/10.1136/tobaccocontrol-2016-053563.)

The article concludes: "Our findings contradict courts’ conclusions that pictorial messages are emotional and not factual. Pictorial labels are rated as informative and factual, textual labels evoke emotion, and emotionality and informativeness are strongly correlated. These findings serve as evidence for the Food and Drug Administration (FDA) to counteract the claim that pictorial warning labels, by definition, are not ‘purely factual and uncontroversial’."

The Rest of the Story

There are a number of reasons why this analysis is wrong on the law, but the first is that it ignores the word "purely." What this paper shows is that graphic images can not only invoke emotion, but also provide information. If the criterion for applying a low level of scrutiny (i.e., using the Zauderer standard) was that a compelled statement must have factual content, then this research might be relevant. However, the issue at hand is whether the compelled statement is "purely" factual. With the FDA's proposed graphic warning labels, this was clearly not the case. The graphic images were specifically chosen to evoke high levels of emotion and therefore to accomplish the government's purpose of persuading smokers to quit. That this was the real purpose of the required labels is evidenced by the fact that the FDA included the 1-800-QUIT-NOW hotline number on the packages.

In order to apply the Zauderer standard, the intended purpose of the compelled speech must be to prevent the dissemination of misleading, deceptive, or false information. Compelling a manufacturer to include a warning message that persuades the consumer not to purchase the product has never been the type of commercial speech to which Zauderer has been applied, even if such a message conveys some factual information.

For example, the government can certainly require an alcohol manufacturer to include a warning on a bottle informing consumers that alcohol consumption is linked to adverse pregnancy outcomes, liver disease, or cancer. However, requiring the bottle to include the message "PLEASE DO NOT PURCHASE THIS PRODUCT. PLEASE STOP DRINKING IMMEDIATELY AND COMPLETELY" would obviously not fall under the Zauderer standard.

The bottom line is that the government cannot compel a company to provide warning labels that essentially hijack the packaging and use it as an anti-smoking billboard. The government is free to convey anti-smoking messages through its own advertisements. But it cannot hijack the companies' packaging and advertisements and compel speech that is specifically urging consumers not to purchase the product. Even if some factual information is conveyed, this does not fall under the Zauderer standard for a low level of scrutiny.
Original author: Michael Siegel
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Is the Campaign for Tobacco-Free Kids Even Capable of Being Honest?

In a press release issued last Friday, the Campaign for Tobacco-Free Kids once again accused the tobacco companies of marketing cotton candy e-cigarettes to youth.

The press release states: "This bill would make it much harder for the FDA to limit the sale or marketing of these products and, by making current products the industry standard, much easier for tobacco companies to continue marketing products in kid-friendly flavors like cotton candy and cherry crush."

The Rest of the Story

After an extensive internet search, I am unable to find a single tobacco company that markets cotton candy e-cigarettes.

It is now clear that the Campaign for Tobacco-Free Kids' repeated false statements are not merely a careless mistake. They are intentionally lying to the public in order to create a story that fits their pre-conceived model.

In my view, this behavior violates the public health code of ethics. Two key principles in this code are "truth telling" and "transparency" (i.e., not concealing information).

Not only is the Campaign failing to tell the truth regarding cotton candy e-cigarettes but it is also concealing information about the actual effect of the Cole-Bishop rider on the FDA's ability to restrict the marketing of e-cigarettes to youth. This amendment would not curtail the FDA's ability to regulate the marketing of e-cigarettes at all. The FDA remains free to promulgate any regulations it wants to restrict marketing of these products to youth. All the amendment does is to make it more difficult to market deadly tobacco cigarettes by ensuring that competition from much safer tobacco-free vapor products can continue. But the FDA is free to subject those products to any marketing restrictions that it deems advisable.

Honesty is critical in public health not only because it is essential to ethical conduct, but also because without it we risk losing the public's trust. The actions of the Campaign are therefore quite selfish: they are risking the credibility of the entire tobacco control movement just so that they can tell a more damning story about the tobacco industry to potential donors.
Original author: Michael Siegel
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CDC: E-Cigarettes More Popular Than FDA-Approved Quitting Aids




Cigarette smokers prefer e-cigarettes to FDA-approved quit methods, according to a research brief authored by the CDC Office on Smoking and Health, RTI International and the University of North Carolina (here).

Using a nationally representative online survey of 15,943 adult smokers who tried to quit during the past three months, they found that 75% used one or more methods to quit, and 25% used only one method, as shown below.







.nobr br { display: none } td { text-align: center}
Weighted Prevalence (%) of Methods Used By 15,943 Adult Smokers Who Attempted to Quit in Past 3 Months
Quit MethodOne Method OnlyMultiple Methods



Gave up cigarettes all at once14.7%65%
Gradually cut back6.662
Partially substituted e-cigarettes1.135
Switched completely to e-cigarettes1.125
Used nicotine gum or patch0.825
Used Zyban or Chantix0.412
Switched to “mild” cigarettes0.320
Sought help – health professional0.215
Sought help – websiteless than 0.17
Sought help – telephone quitlineless than 0.17


All methods25.375

E-cigarettes were far more popular single quit aids for partial or complete substitution (2.2%), compared with nicotine patches/gum (0.8%) or other prescription medicines (0.4%).  They were also more popular when more than one aid was used.

Of note, telephone quitlines were rarely used.  The government has poured millions of dollars into this mini-industry, yet quitlines were used by a mere 0.02% (unweighted, n=3) of smokers as single quit aids in this study.

Participants here were current smokers.  A similar analysis performed on former smokers will show even more impressive effects from vaping.

Despite the current study’s evidence of vaping’s popularity among smokers, the authors’ summation was understated: “Given that our data show that e-cigarettes are more commonly used for quit attempts than FDA-approved medications, further research is warranted on the safety and effectiveness of using e-cigarettes to quit smoking.”

The fact is that the CDC has documented with real-world data that e-cigarettes are preferred smoking cessation aids, negating the argument that evidence is merely “anecdotal” (here). 

Our government should adopt the UK Royal College of Physicians’ position that “the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.” (here).  In Britain e-cigs have been the leading quit-smoking aid since 2013 (here, page 46).




Original author: Brad Rodu
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What is peer review really? (part 9 — it is really a crapshoot)

by Carl V Phillips

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Age Restrictions on Smoking, Drinking and Driving



State legislatures have been lobbied in a coordinated effort, called Tobacco 21 (here), to raise the minimum age for tobacco sales from 18 to 21 years.  Hawaii, California and the District of Columbia have adopted the higher age limit, but numerous city and county ordinances have been passed.

As an advocate of tobacco harm reduction, I strongly oppose any tobacco use by teenagers.  However, I am unconvinced that implementing a smoking ban for those under 21 is an effective strategy.

One of the arguments for Tobacco 21 is that the same age limit has reduced teenage drinking.  The National Minimum Drinking Age Act was passed in 1984.  By 1988, all states prohibited alcohol purchase by those under 21.  The impact on underage drinking is debatable.  It has been on the decline for many years, but rates remain disturbingly high (here). 

The chart above shows past-month (i.e., current) cigarette smoking, marijuana use, alcohol consumption and binge drinking (5 or more drinks on one occasion) among 16-17, 18-20 and 21-25 year olds in the 2014 National Survey on Drug Use and Health.  Despite almost 30 years of Alcohol 21 across the county, nearly a quarter of 16-17 year-olds and 44% of 18-20 year-olds were currently drinking, compared with 11% and 24% who were smoking.  In addition, a majority of drinkers were binging.  In 2014, recreational marijuana wasn’t legal for anyone, yet 15% of 16-17 year-olds and 21% of 18-20 year-olds were using that drug. 

We can also compare these figures with those from 10 years earlier.  Here are the changes in current use from 2004:

.nobr br { display: none } td { text-align: center}
Percentage Change From 2004 to 2014 in Prevalence of Youth and Young Adults Who Currently Smoke, Toke, Drink or Binge Drink





Age (yrs)SmokeToke(%)DrinkBinge Drink





16-17-51+6-28-41
18-20-36+17-14-23
21-25-25+25+4-1

With Alcohol 21 in force for almost 30 years, drinking and binge drinking declined moderately among 16-17 year olds.  But smoking saw the steepest declines in all age groups, even in the absence of a ban for 18-20 year-olds.

Alcohol 21 and Tobacco 21 laws are promoted to save lives.  In the case of smoking, the lives saved are far in the future, as smoking generally takes a toll in advanced age.  With alcohol, the lives saved are primarily from traffic accidents.  With or without alcohol, traffic accidents are the number one killer of youth and young adults (age 16-24 years), with about 7,000 deaths each year (here).  Legislators seeking immediate life-saving impact should consider further age-restricted driving licenses. 



Original author: Brad Rodu
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Excellent VICE News Segment on Electronic Cigarettes

You can view the segment here.
Original author: Michael Siegel
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Real implications of the RSPH “sting” of ecig vendors

by Carl V Phillips

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In cheap publicity stunt Royal Society of Public Health sounds a fake alarm about a non-problem

Today the Royal Society of Public Health is pitching its ‘undercover investigation’ into vape shops selling stuff to adults who don’t smoke. Naturally, the primary purpose of this exercise has little to do with public health but is a publicity stunt for an ailing organisation in a declining field that offers ever less to the public or to health.

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The Human Toll of Anti-Tobacco Extremism



This is a tale of two tobacco users and the very different medical advice they received.

In 2005, two physicians and a dentist published a report in the American Journal of Psychiatry(reference here):

“Ms. A, a 52-year-old woman with schizoaffective disorder, bipolar type, started smoking shortly after her first psychotic episode at age 19 and, on average, smoked about 1½ packs per day for 33 years. She had attempted to quit using pharmacotherapy, nicotine gum, or patches in combination with cessation classes. Both gum and patch treatments were ineffective since they did not control her craving for cigarettes.

“Her motivation to quit was strong because of the sequelae of smoking: bronchitis, isolation from others, and destabilization of her psychiatric illness from frequently awakening to smoke. Her brother with a bipolar disorder had experienced severe burns over most of his body and died secondary to a fire caused by his smoking. For her, smoking had become a constant reminder of his suffering, which led to nightmares and further isolation. She was afraid to jeopardize the health and safety of others.

“One year ago, she was cross-titrated over a 1-week period to oral pouches. Since that time, she has not resumed smoking, and her psychiatric and medical symptoms have stabilized. Before her cessation of smoking, she lived an isolated existence. Now she resides with and cares for her parents. For Ms. A, ceasing to smoke was a life-changing event.” 

A disabled veteran with post-traumatic stress disorder sent me this email:

“My doctor has been pounding me regarding mouth cancer and me dipping. I have good oral hygiene, but she insists I will get cancer. I now find myself worrying sick every time I have a wrinkled gum, or cut from a chip....etc.

“Please give me advice.

“Should I be concerned and quit dipping and switch to a vape or gum??  It is about to drive my wife nuts, it seems I’m always looking at my mouth now, and the doctor has her convinced too that I’m at a 4 times more likely [to get mouth cancer] than a non dipper.  Your input to ease my mind please.  I do not have a laptop, but saw your book.  Can’t read it on the phone.  So thought I’d ask.  My grandfather, right here in Kentucky smoked Pall Mall nonfilter cigs for 65 years...he died from a bleeding stomach ulcer caused by aspirin... I NEED TRUTH AND PEACE OF MIND. So I don’t become ocd more than I am since she gave my wife all these statistics.  I’d rather hear the blunt truth.

“Should I be worried?

“I’m 41, dip a can in a day and half, have dipped for 17 years since I went in the Army. I have high BP...(according to them) 140/84..

“Appreciate it very much if you would kindly respond.”

I asked the writer to put me in contact with his physician, so that I could provide her with factual information and resources for the benefit of all her patients.

These stories are polar opposites, but equally poignant.  Doctors in 2005 successfully switched a patient with severe mental problems from cigarettes to smokeless tobacco, citing two of my studies (here and here) as the scientific basis for their humane and “life-changing” guidance.  In 2017, a misinformed physician tormented a disabled veteran about smokeless tobacco’s negligible mouth cancer risk (here).     

Too many doctors cause unnecessary suffering among tobacco users and their families.  Their actions are influenced by the misguided crusade against smokeless tobacco conducted by many government agencies and prohibitionist organizations.  This harmful disinformation effort must end.



Original author: Brad Rodu
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Penn Medicine Expert: Smoking May Be No More Hazardous than Vaping

An expert at Penn Medicine - the University of Pennsylvania's health care system - is telling the public that smoking cigarettes, like Marlboros, Camels, and Newports, may be no more hazardous to your health than vaping a tobacco-free e-liquid.

According to the expert: "We know that cigarettes are unsafe after 40 years of exposure. We don’t have 40 years of exposure to e-cigarettes to know what the danger is. We don’t know the safety profile, so we can’t say that e-cigarettes are safer than traditional cigarettes."

The Rest of the Story

Well, if we can't say that e-cigarettes are safer than traditional cigarettes, then what the expert is saying is that we can't say that smoking is any more hazardous than vaping.

This is an absurd statement, completely in conflict with scientific evidence, and not even the tobacco companies would make such a claim.

In fact, the tobacco companies could have a field day with this. If I were Altria, I would take out huge newspaper advertisements in all the leading papers stating: "Medical Expert Says that Smoking May Be No More Hazardous than Tobacco-Free Vaping."

In other words, the statement of this expert is essentially a huge advertisement for tobacco cigarettes, the most deadly consumer product on the market in terms of its toll on the lives and health of Americans.

The evidence that smoking is more hazardous than vaping is overwhelming. Asthmatic smokers who switch from smoking to vaping experience an immediate and dramatic improvement in their lung function, both measured subjectively in terms of respiratory symptoms and objectively in terms of spirometry testing. Hypertensive smokers who switch to vaping also experience a lowering of their blood pressure. A substantial decline in blood levels of many toxins and carcinogens has been documented in vapers compared to smokers.

In short, there just isn't any doubt that smoking is more hazardous than vaping. To suggest otherwise is not only incorrect, but it is damaging to the public's health.

Even the tobacco companies are not willing to lie to that extreme in order to promote cigarette smoking. While they easily could capitalize on statements like that of this Penn Medicine expert, they are refraining from doing so.

It's not clear to me why a medical professional would promote cigarette smoking in this way, but he has good company. A large number of medical and health organizations and agencies have made exactly the same claim.

The FDA and the CDC need to come out immediately with unequivocal statements that vaping is safer than smoking. Their failure to do so is a huge part of what is contributing to the deception of the public about the relative risks of vaping and smoking.
Original author: Michael Siegel
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LA Times editorial about dishonest public health (ok, not really)

by Carl V Phillips

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Vaping Opponents Have Lost Scientific Rigor; Now Concluding that E-Cigarettes Cause Heart Attacks Based on a Science Fair Project

Vaping opponents are using the results of a new "study" as evidence that vaping causes heart attacks.

Here is what my colleague Dr. Stan Glantz wrote about this "study":

"Every time I have posted a comment on a new study showing that e-cigarettes adversely affect blood vessels and blood in ways that increase risk of a heart attack, a friend and colleague who remains part of the (shrinking) collection of e-cigarette enthusiasts emails me and with he comment that, “if they are so bad where’s the evidence that e-cigarettes increase the risk of a heart attack?”  The first evidence just appeared. Using the National Health Interview Survey (NIHS), a large national survey done in the US, Nardos Temesgen and colleagues at George Washington University, found that the odds of a heart attack  increased by 42% among people who used e-cigarettes. This increase in risk was on top of the increases in risk due to any smoking that the e-cigarette users were doing. ... E-cigarette use increases the risk of a heart attack about as much as having diabetes. ... e-cigarettes represent an independent cause of heart attacks."

The Rest of the Story

Claiming that vaping causes heart attacks is a hugely important conclusion. And it is particularly important if vaping is as strong a risk factor for heart attacks as diabetes. If true, then the cardiovascular risks associated with vaping are not much lower than those associated with smoking, and the health benefits of switching from smoking to vaping are grossly overstated.

Before condemning electronic cigarettes, however, let's take a look at the rest of the story.

First, let's take a closer look at this "study." In what journal was it published?

It turns out, it was not published in any journal. It is not a peer-reviewed study.

In fact, it turns out that this study is merely an abstract that was presented by medical students at what is essentially a "science fair" project -- a "research day" in which medical students present posters summarizing their research. Now I'm not trying to demean medical student research, because that's how I started out myself, and two papers that I published as a medical student were actually quite interesting (one was the first to show that a dietary supplement - L-tryptophan - could cause pulmonary hypertension). However, these were peer-reviewed publications accepted by reputable medical journals. I wouldn't base a far-reaching conclusion on a medical school research day abstract.

Second, let's take a closer look at the study itself.

The study was merely a cross-sectional examination of the relationship between any history of a heart attack in the past and current e-cigarette use. The study did not follow people over time to see whether those using e-cigarettes were more likely to have a heart attack. Nor did it identify heart attack cases and retrospectively assess e-cigarette use. Instead, it was just a cursory, cross-sectional look at e-cigarette use prevalence among people with and without a lifetime history of a heart attack.

The study in no way proves that e-cigarettes cause heart attacks. It merely shows an association between ever having had a heart attack and currently using e-cigarettes, after controlling for smoking status. It is very possible (and quite likely) that many, if not most of the people with a history of myocardial infarction had experienced heart attacks years ago. And it is similarly likely that many of these heart attack victims had experienced the heart attack prior to starting to vape. In fact, it is likely that having a heart attack or a history of a heart attack was a stimulus that led the person to try vaping (because of the urgent need to quit smoking).

What the paper might actually be showing is simply that smokers who have experienced a heart attack are more motivated to try vaping to quit than smokers who have not had similar health problems. This makes complete sense and is certainly a plausible alternative explanation for the study findings.

Even the medical students who conducted the study do not conclude that vaping causes heart attacks. Appropriately, they merely conclude that they found a cross-sectional association and that further research is necessary before any conclusions can be drawn.

This is a great demonstration of what social scientists call "confirmation bias." When people have a pre-existing belief (i.e., vaping is terrible), they tend to interpret any scientific information in a way that reinforces their pre-existing beliefs (i.e., this study shows that vaping causes heart attacks). But science and scientific research is supposed to overcome this confirmation bias by establishing principles and procedures to promote objectivity.

Clearly, this is not happening with regards to the science of vaping. Now, vaping opponents have lost any semblance of scientific rigor and are willing to promote any research - even what essentially amounts to a science fair project - as supporting their pre-existing beliefs.
Original author: Michael Siegel
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My Response to Campaign for Tobacco-Free Kids' Article Published in The Hill

In a letter to the editor published in The Hill, I respond to an op-ed piece published a few days ago in The Hill by the Campaign for Tobacco-Free Kids. In that piece, the Campaign once again suggested that Big Tobacco is "peddl[ing] candy-flavored wares to kids." It also argues that the current FDA e-cigarette deeming regulations are the best way to: "ensure that smokers have access to products that will actually benefit their health."

In my letter, I take issue with the contention that the current FDA regulations are in any way helping to ensure that smokers have access to products that will benefit their health (namely, e-cigarettes) and that in fact, the regulations make it nearly impossible for e-cigarettes to enter or continue on the market. Instead, the regulations protect cigarette sales from competition by much safer tobacco-free vaping products.

The piece begins: "In his op-ed (“Congress, don’t help Big Tobacco peddle candy-flavored wares to kids,” March 26), Matthew Myers of the Campaign for Tobacco-Free Kids argues that the current FDA regulations regarding electronic cigarettes do not impede the ability of companies to put truly safer products on the market to compete with conventional tobacco cigarettes. But the opposite is true. By requiring every new product to submit burdensome and expensive applications, the regulations make it nearly impossible for companies to introduce new and safer vaping products into the market."

You can read the rest of the letter, entitled "Why is the FDA favoring real cigarettes over fake ones?" here


NOTE: The letter mistakenly refers to the legislation as HR 1156, but the current bill number is HR 1136.
Original author: Michael Siegel
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Problems Multiply for Proposed FDA Smokeless Tobacco Rule



The FDA on January 23 published a proposed smokeless tobacco (ST) regulation that would require a radical reduction in levels of N-nitrosonornicotine (NNN), a tobacco-specific nitrosamine.  I documented (here) that the rule is based on erroneous calculations of ST risks; others have since raised additional concerns.

Scott Ballin, Health Policy Advisor to the University of Virginia’s Morven Dialogues, observes that the FDA ignored its statutory requirement, when setting product standards, to “invite appropriate participation though joint conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, agricultural or consumer organizations who in the Secretary's judgment can make a significant contribution.”

Brian Fojtik, Senior Fellow at the Reason Foundation, notes (here) that the FDA invited participation from selected stakeholders: “Within hours of publication in the [Federal] Register, a comment was filed by a coalition of interest groups collaboratively (American Academy of Pediatrics, Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco Free Kids and Truth Initiative) . . . a reasonable person is left wondering how six large organizations could possibly have each reviewed a highly technical, 50-page rule, reached conclusions on the rule’s specific merits and crafted a collaborative response that all agreed to sign within hours of the rule’s publication in the Register.  Even in the most forgiving of lights, the appearance is unseemly and should necessitate the withdrawal of the proposed rule.”

Another major error in the FDA’s proposed rule-making process was identified by Altria in a March 3 comment submission.  The agency filed a regulatory impact analysis (here) for the rule, estimating that 30% of moist snuff products currently meet the 1 ppm dry-weight limit (Table 3, panel A).  However, FDA miscalculated the wet-weight to dry-weight conversion, invalidating the estimate. 

Moist snuff is about 50% water; when it is dried, the level of any agent in the remaining tobacco will double.  The FDA did the reverse, calculating that a product with 2 ppm NNN wet-weight would have 1 ppm dry weight.  The correct conversion is 0.5 ppm wet-weight to 1.0 ppm dry weight.  Almost no moist snuff products on the U.S. market are at 0.5 ppm wet weight.

Altria urged the FDA to withdraw the proposed rule because it “would fail to provide a scientifically valid formula for manufacturers to measure and maintain records of NNN levels on a dry weight basis in order to demonstrate compliance with the product standard.”



Original author: Brad Rodu
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IN MY VIEW: Campaign for Tobacco-Free Kids' Lying Has Got to Stop

In an action alert emailed today to its constituents, the Campaign for Tobacco-Free Kids insinuated that the tobacco companies are producing gummy worm electronic cigarettes. The title of the email is "Gummy worms," and the headline of the action alert states that "tobacco companies" are "luring kids with candy-flavored e-cigarettes and cigars."

As I've noted previously, this is simply not true. None of the tobacco companies is producing gummy worm-flavored electronic cigarettes.

While the Campaign for Tobacco-Free Kids has every right to fight for a ban on e-cigarette flavorings (a policy with which I vigorously disagree), it has no business lying to and deceiving its constituents in order to promote such a ban.

Telling the truth to its constituents would apparently not be glitzy enough for the Campaign. So instead, it has to lie by making the public think that Big Tobacco has sunk to the level of trying to get kids to use gummy worm-flavored nicotine products. This may be a catchy and eye-grabbing claim that succeeds in getting people riled up, opening up their pocket books, and eliciting donations, but it does so by misleading and deceiving them. That's fundamentally dishonest and unethical, and I don't believe a campaign like this has any place in public health.

Why is the truth not enough?

The Rest of the Story

Perhaps the reason that the truth is not enough is that the truth destroys the made-up story that the Campaign for Tobacco-Free Kids is trying to tell. Their story is that Big Tobacco is up to its old tricks, trying to seduce and addict kids to electronic cigarettes through outrageously blatant appeals to obvious youth-appealing flavors like gummy bear, gummy worm, and cotton candy. But unfortunately for the Campaign, that's not the truth. The truth is that the largest cigarette company in the United States - Altria - produces its MarkTen XL Bold e-cigarettes in only two flavors: tobacco and menthol. And their original MarkTen e-cigarettes come in only four flavors: tobacco, menthol, fusion, and winter mint.

If Altria were truly interested in getting kids addicted to e-cigarettes, I hardly think that it would restrict itself to tobacco, menthol, fusion, and winter mint, when there are thousands of sweet-tasting, candy, fruit, and dessert flavors available that they could be marketing.

The truth just destroys the Campaign's story. But apparently, the Campaign's motto is "never let the truth get in the way of a great story."

The real story is not a pretty one. The rest of the story is that the Campaign for Tobacco-Free Kids continues to incessantly deceive the public by falsely accusing tobacco companies of marketing gummy worm, gummy bear, and cotton candy electronic cigarettes to children.

Look - I have issued my fair share of accusations against the tobacco companies. I testified in about 10 cases against Big Tobacco, one of which resulted in a $145 billion verdict against the companies. But my testimony was always based on the facts. There were different ways to interpret those facts, but I would never lie or deceive the jury in order to try to make a point or embellish the case.

If we issue false accusations like this against the tobacco companies, then what reason is there for anyone to believe us when we complain about actions that they really have taken?

Perhaps this is why the actions of the Campaign for Tobacco-Free Kids are so disturbing to me. They tarnish the reputation of the entire tobacco control movement, including myself.
Original author: Michael Siegel
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Editors of Tobacco Control attack blogs: protecting science from cranks, or activism from science?

 

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