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Mountain Vapor Blog

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.

FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 2)

by Carl V Phillips

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FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 1)

by Carl V Phillips

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Time to stop measuring risk as “fraction of risk from smoking”?

by Carl V Phillips

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American Lung Association in Wisconsin is Lying About Health Effects of Smoking

It used to be that the tobacco industry lied to the public in order to downplay the severe health effects of cigarette smoking. Today, it is the Wisconsin branch of the American Lung Association (ALA) that is lying about the risks of smoking.According to the director of tobacco control and public policy for the ALA in Wisconsin: "there’s still a perception that e-cigarettes are less harmful than regular cigarettes and so for some kids who never would have tried smoking cigarettes they get the idea this might be a safer alternative."Clearly, the ALA is telling the public that kids are actually mistaken and that e-cigarettes are no less harmful than regular cigarettes. Of course, this also means that cigarettes are no more dangerous than e-cigarettes. The Rest of the StoryThe truth is that e-cigarettes are much safer than regular cigarettes. Dr. Stan Glantz - a highly respected, long-time scientist in the anti-tobacco movement - has stated unequivocally that e-cigarettes are safer than regular cigarettes and that if a smoker switches to e-cigarettes exclusively, they will experience an improvement in their health. Dr. Glantz may quibble with some of us who support harm reduction in terms of the exact magnitude of the risk differential, but there is no credible scientific doubt that vaping is safer than smoking.Even the cigarette companies are not lying to the public about this point. In fact, they readily admit that their cigarettes are much more dangerous than regular cigarettes and they are even making efforts to market e-cigarettes as a less hazardous alternative.So why is the American Lung Association picking up where the historical fraud and deception of the tobacco industry ended?Like the ALA, I do not want youth to be taking up vaping. However, unlike the ALA, I don't condone lying to our nation's youth in order to try to deter them from vaping. Especially since the ultimate effect of downplaying the health hazards of smoking is that it will produce less deterrence to youth smoking. If kids think that smoking is only as bad as inhaling cherry vapes and blowing a few vape rings, then their appreciation of the serious health hazards of smoking will be undermined, which of course will lead to more kids smoking.As Alan Selk said eloquently in his comment to the article in which the ALA was quoted:"Donna Wininsky's statement that there is still a perception that e-cigarettes are less harmful than regular statements is a pretty bizarre statement, considering that e-cigarettes are in fact significantly less harmful then regular cigarettes. All the real evidence points to that fact. It has also been shown that about 80% of kids who are using e-cigs are not using nicotine. They are simply playing with the vapor. A great majority of the youth who are using nicotine are using it as a substitute (and a much less harmful one) for smoking. ... ""As far as health goes there is only one number that matters, and that is how many people are inhaling smoke from cigarettes. Those numbers are at historic lows among youth and adults. There is good evidence that the reason for the drop is because people are switching to low risk alternatives. That is a very positive news. (in the UK, where e-cigs are endorsed by the health establishment as a viable harm reduction tool, and people are generally better informed as to the relative risk of smoking verses vaping, 50% of people who take up vaping end up completely quitting cigarettes).""I would like to know why, instead of encouraging people to switch to a far less harmful alternative to cigarettes, the American Lung Association of Wisconsin is misinforming the people of Wisconsin on the relative risk of vaping verses smoking. They are in fact killing people with there misinformation campaign." The ALA is not only wrong in its assessment of the relative health effects of vaping compared to smoking, but it is also wrong in suggesting that e-cigarette use among youth in Wisconsin is a problem because it leads to cigarette use. The evidence from Wisconsin suggests exactly the opposite. According to the state's Youth Tobacco Survey, while e-cigarette use among high school students in Wisconsin continued to increase substantially from 7.9% in 2014 to 13.3% in 2016, smoking prevalence declined by 24%, from 10.7% to 8.1%. These data are not consistent with the assertion that e-cigarettes are serving as a gateway to smoking among Wisconsin youth. In fact, they suggest the opposite. As Alan Selk correctly argues, e-cigarettes appear to be serving as a deterrent to smoking as a culture of vaping replaces, rather than reinforces, a culture of smoking.Original author: Michael Siegel
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New CDC Data Should Put to Rest the Contention that E-Cigarettes are a Gateway to Youth Smoking

New data released moments ago by the Centers for Disease Control and Prevention (CDC) should put to rest the contention that electronic cigarettes are a gateway to smoking among youth. These new data show that the prevalence of smoking among high school students was cut in half in just five years - from 2011 to 2016 - at the same time as the use of e-cigarettes among these very same students increased dramatically from 1.5% to a peak of 16.0% in 2015.There is more good news from the CDC. Not only has youth smoking declined at an unprecedented pace in the last five years, but for the first time, the prevalence of youth use of e-cigarettes has also declined, dropping from 16.0% in 2015 to 11.3% in 2016 (among high school students). Use of cigarettes among high school students continued to fall between 2015 and 2016, dropping from 9.3% to 8.0%.The Rest of the StoryThis is great news because it reveals that smoking is truly becoming unpopular among youth. The rate of decline in youth smoking is unprecedented. This despite the rapid rise in e-cigarette experimentation. These data are simply not consistent with the hypothesis that vaping is going to re-normalize smoking and that e-cigarettes are a gateway to youth smoking.The drop in e-cigarette use is also reassuring because it suggests that vaping is largely a social phenomenon that involves experimentation and that the addictive potential of these products is quite low. It also suggests that the popularity of youth vaping has peaked and that concerns about vaping taking over and leading to nicotine addiction among a huge proportion of youth are not warranted.If anything, the real concern at this point is whether the decline in e-cigarette use might actually slow the unprecedented declines we have seen in youth smoking.Original author: Michael Siegel
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CDC Bemoans the Fact that the Public Has an Accurate Understanding of Secondhand Vaping Risks

In an article published in the journal Preventing Chronic Disease, researchers from the Centers for Disease Control and Prevention (CDC) report the results of a national survey of U.S. adults to assess their opinion regarding the harmfulness of exposure to "secondhand" vaping (i.e., exposure to the air in a place where vaping is taking place).The results of the study were as follows: "Overall, 5.3% of adults responded that secondhand EVP exposure caused “no harm” to children, 39.9% responded “little harm” or “some harm,” 21.5% responded “a lot of harm,” and 33.3% responded “don’t know.”"The article concludes: "Current cigarette smokers and EVP users had greater odds of reporting that exposure to secondhand EVP aerosol causes “no harm” or “little harm” or “some harm” to children compared with never cigarette smokers and never EVP users. However, scientific evidence indicates that EVP aerosol exhaled into the air potentially exposes nonusers to aerosolized nicotine and other harmful and potentially harmful substances, including heavy metals, ultrafine particulates, and volatile organic compounds."It appears that CDC has concluded that the correct answer to the question is "a lot of harm" and that answers of "no harm," "little harm," or even "some harm" are incorrect. Therefore, more education is needed to inform the public of the "harms" (apparently, the substantial harms) of secondhand vaping. The basis of the CDC's contention that secondhand vaping is very harmful is that "this aerosol is not as safe as clean air" and that it "is not harmless and that it can contain harmful and potentially harmful chemicals, including nicotine." The Rest of the StoryApparently, the CDC has forgotten one of the major principles of environmental health, which is that the dose of exposure to a chemical is critical in assessing its health impact. Just because e-cigarette aerosol has been found to contain nicotine and some other chemicals does not mean that it is substantially harmful. What matters is the actual exposure, which is dependent upon the levels of these chemicals in ambient air under actual (real-life) conditions and the duration of exposure. To date, there is no evidence that there is any substantial exposure to harmful chemicals in real-life situations that most adults and children encounter. On the contrary, there is evidence that secondhand "vapor" dissipates rapidly and that exposure to nicotine and other chemicals is very low.While I agree that public education about the risks of vaping is needed, I believe that "public education" implies giving people the actual facts, not making things up or exaggerating harms that are not known to exist.Here, the CDC is clearly suggesting that we mislead the public by trying to convince them that secondhand vaping is a significant public health hazard when in fact the evidence suggests the opposite.The worst that the CDC can document about secondhand "EVP" is that it is "not as safe as clean air" and that it is "not harmless." That is hardly a ringing endorsement of EVP representing a substantial public health problem or of EVP being very harmful.Moreover, people who state that they "do not know" the hazards cannot be viewed as being ignorant, as the CDC would have us believe, because there is not a huge body of literature on this topic and the exact risks have not yet been quantified. But there is certainly no evidence at present that secondhand vaping is harmful. Therefore, we cannot say that people who believe that EVP is "not harmful" are wrong.Clearly, the CDC is not interested in the actual scientific facts. They are simply interested in scaring people about the harms of secondhand vapor - harms that have not been shown to exist. The CDC is engaging in an unwarranted scare campaign against e-cigarettes and apparently is trying to demonize these products because, for some reason, it doesn't like them.The unfortunate part of this is not merely that the CDC is violating principles of public health by deceiving the public and by making claims that are not substantiated by scientific evidence. The CDC's statements are also a tangible threat to the public's health. By deceiving people about the risks of e-cigarettes, CDC is actually undermining the public's appreciation of the hazards of smoking and the tremendous difference in risk between the use of combustible tobacco products and the use of tobacco-free, smoke-free, non-combusted products. This could lead to smokers deciding not to quit because there is no point to vaping if it is just as harmful as smoking. It could also lead to former smokers returning to smoking for the same reason.In this era of the government relying upon and disseminating "alternative facts," it is especially inappropriate for the CDC to be waging a campaign of deception about the health effects of vaping and secondhand vaping.Original author: Michael Siegel
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San Francisco, CA - Local Alert - Help us stop the flavor ban!

(Update - 05.20.17)

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Help us send letters to HHS Sec. Tom Price - #DelayFDA

Earlier in March, CASAA, AVA, SFATA, and VTA sent a joint letter to House leaders urging them to support HR 1136, which would modernize the 2007 predicate date for vapor products newly deemed to be tobacco by the FDA. In keeping with the spirit of cooperation, we are working together again to generate messages to HHS Secretary Tom Price with the engagement below. If you own or manage a vapor shop, please find a space to provide this opportunity to your customers.

The letter we are providing urges Secretary Price to delay implementation of the FDA deeming regulations. Without this delay, many in the vapor industry will begin closing down their operations. If action is not taken soon, consumers will be losing access to reliable, affordable, life-saving vapor products.

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Why is the Campaign for Tobacco-Free Kids Congratulating a Political Leader Accused of the Murder of Thousands of Innocent Civilians?

In a press release issued this past Tuesday, the Campaign for Tobacco-Free Kids congratulated Dr. Tedros Adhanom Ghebreyesus on his election as the new Director-General of the World Health Organization (WHO).Dr. Ghebreyesus' CV notes that he "facilitated critical health investments and reforms that helped expand health care access to tens of millions of Ethiopians," which sounds like a strong qualification for his election to this position as leader of WHO. However, the CV is only telling part of the story.The Rest of the StoryThe rest of the story is that Dr. Ghebreyesus, as one of the nine executive members of the politburo of the Tigray People’s Liberation Front (TPLF) - according to the Ethiopian Advocacy Network, has been accused of leading a campaign of repression and murder that some have even called a genocide.According to multiple sources, the TPLF has allegedly engaged in severe repression of civilian protests in Oromia and Amhara, including a military response in which more than 1,000 innocent civilians were killed, hundreds of thousands imprisoned, and millions displaced.The repression of dissent in Oromia is documented by a 2014 Amnesty International report, which confirms the TPLF's role in arbitrary arrest of civilians based purely on dissent or suspected dissent, the arrest of peaceful protestors and students, violations of free speech and assembly rights, violation of the right to education, and even "arbitrary detention," "enforced disappearance," "extra-judicial executions," and "torture," including rape, psychological torture, torture in and out of detention, and forced labor.A 2016 report at Genocide Watch outlines numerous human rights violations by the TPLF and concludes that TPLF orchestrated a "genocidal plan systematically designed by the TPLF regime using the unfair land use policy as a tool in Oromia and Southern Ethiopia to achieve the political goal of complete ownership of the land through silent eradication of the indigenous communities in the long-term. “Genocide Watch considers Ethiopia to have already reached Stage 7, genocidal massacres, against many of its peoples, including the Anuak, Ogadeni, Oromo, and Omo tribes.” The people of Oromia in particular, and all oppressed peoples of Ethiopia in general, are struggling to reverse this policy of systematic genocide waged on them by successive regimes of Ethiopia."While some of this alleged genocidal campaign occurred prior to Dr. Ghebreyesus' tenure, it has been estimated that "more than 1000 civilians have been killed by the regime in last 10 months (November 2015 to September 2016)."The Oramian Economist describes the TPLF's rule as a system of social and economic "apartheid."Dr. Ghebreyesus' campaign for the WHO directorship is widely characterized as a political campaign funded by the TPLF for political gain. His election was opposed by massive numbers of Ethiopians, apparently on the basis of his alleged "involvement in the killings hundreds of thousands of peaceful protestants. Last year alone, more than well over 1000 civilians were killed by the regime that Tedros Adhanom is fiercely and passionately supporting – the ethnic TPLF government."Under these circumstances, I find it shameful that the Campaign for Tobacco-Free Kids offered its congratulations to Dr. Ghebreyesus and is supporting his election to the Director-General position of the World Health Organization. It appears that Dr. Ghebreyesus is someone who should be investigated by the World Health Organization for public health atrocities, not someone who should be leading the organization.The Campaign for Tobacco-Free Kids' support for Dr. Ghebreyesus casts a dark cloud on the entire tobacco control movement.  I call on the Campaign for Tobacco-Free Kids to retract its statement and apologize for its support of a political leader who is accused of being involved in the murder of thousands, participation in human rights violations, and supporting a policy of systematic genocide.I expect an immediate response, given the grave nature of the alleged human rights violations.Original author: Michael Siegel
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Government Testing of Another Vape Shop Reveals No Cause for Concern about Secondhand Vaping

Government officials have now completed an investigation of a second vape shop, finding that levels of chemicals of concern are minimal in the ambient air of the vape shop, thus not posing any significant risk to customers.The evaluation was performed by the National Institute for Occupational Health and Safety (NIOSH). Breathing zone air samples were tested for formaldehyde, acetaldehyde, and three chemicaals associated with "popcorn lung."Results showed that all of these chemicals were well within the NIOSH recommended exposure levels. The formaldehyde and acetaldehyde concentrations were similar to those observed in typical U.S. homes. The "popcorn" lung associated-chemicals were not detected in most samples and detected only at very low levels in the remaining samples.The Rest of the StoryThis is now the second study conducted under the extreme conditions inside a vape shop, and like the first study, it finds that there is no evidence of significant exposure to hazardous chemicals among bystanders in this setting. 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. Formaldehyde and acetaldehyde exposure was no different than in many indoor and outdoor environments at baseline. Chemicals that have been associated with "popcorn lung" were either not detected or detected at very low concentrations.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. Based on the current scientific evidence, I fail to see the justification for banning vaping in most public places. 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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Smokeless Tobacco Company Admits that Its Products Cause Oral Cancer

In its defense of a lawsuit brought by the family of former San Diego Padres great Tony Gwynn who died of oral cancer in 2014, the U.S. Smokeless Tobacco Company has admitted that its products cause oral cancer and that the public was widely aware of it, to the extent that it was "obvious."As reported by USA Today: "The U.S. Smokeless Tobacco Company has filed a response to the family of deceased baseball legend Tony Gwynn, saying that Gwynn was warned about the alleged risks of using smokeless tobacco and that such risks are “commonly known” but Gwynn accepted them anyway. ... “Plaintiffs (the Gwynns) are barred from recovering any damages because the dangers claimed by Plaintiffs, if any, are and were open and obvious,” says the company’s response, filed by attorneys at the firm Shook, Hardy & Bacon."Furthermore, the company argued that: "Gwynn “had the means of knowing, by the exercise of ordinary intelligence, the truth of alleged statements concerning smokeless tobacco use and health.”" The company's primary defenses are two-fold:First, the company argues that the oral cancer risks of smokeless tobacco were widely known, to the point that they should have been obvious to everyone. Second, the company argues that Gwynn's oral cancer was not due to smokeless tobacco, but to some unspecified "pre-existing condition."The Rest of the StoryThis is about the weakest defense imaginable. On the one hand, the company argues that the link between smokeless tobacco use and oral cancer is so clear, so obvious, and so obviously true, that anyone with ordinary intelligence knows that smokeless tobacco causes oral cancer. On the other hand, the company is arguing that despite such an obvious link, Tony Gwynn's oral cancer -- which occurred in the exact spot where he used smokeless tobacco -- was not related to his smokeless tobacco use.This duo of conflicting arguments should not deceive any jury member with "ordinary intelligence."You can't have it both ways. You can't argue that the link between smokeless tobacco and oral cancer is so obvious that anyone should have known that if you put smokeless tobacco into one area in your oral cavity for years, you are likely to develop cancer in that area, but that for some reason, this individual who did exactly that and got cancer at that site got cancer for some other reason. That reasoning should fool exactly no one.I also agree with Northeastern Law School professor Richard Daynard's comment: "Tobacco companies "do what they can to blame the victim,” said Richard Daynard, a law professor at Northeastern University and tobacco industry critic who is not involved in the case. “Their basic defense is, `Only a very weak-willed person would use this product, and it’s his fault and not ours.’ My understanding is that ain’t going to work with Tony Gwynn, with what people know about him. It’s working less and less with people who are not celebrities.”"The company is also going to have a hard time convincing a jury that the link between smokeless tobacco and oral cancer was obvious to anyone with any intelligence, but that the company itself denied such a link, or downplayed and undermined it.Gwynn's death is widely recognized as having helped changed the culture in baseball regarding smokeless tobacco use and has led to an increasing number of bans on the use of smokeless tobacco during professional baseball games.Original author: Michael Siegel
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Op-Ed: Don't Let Alternative Facts Deter Congress from Fixing E-Cigarette Regulations

Here is a link to my op-ed, published today in the Washington Examiner, and entitled: "Don't Let Alternative Facts Deter Congress from Fixing E-Cigarette Regulations."OP-EDOriginal author: Michael Siegel
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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 detectedGlycidol: Not detectedFormaldehyde: 7.2 ppbDiacetyl: Not detected using standard method2,3-Pentanedione: Not detected using standard methodAcetyl butyryl: Not detected using standard methodAcetoin: Not detected using standard methodAcetone: Not detectedEthyl benzene: Not detectedm,p-Xylene: Not detectedo-Xylene: Not detectedToluene: Not detectedAcetaldehyde: Not detectedAcetonitrile: Not detectedalpha-pinene: Not detectedBenzene: Not detectedChloroform: Not detectedd-Limonene: Not detectedMethylene chloride: Not detectedMethyl methacrylate: Not detectedn-Hexane: Not detectedStyrene: Not detectedThe 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 StoryThis 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; andg.       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 StoryThis 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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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 StoryThere 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 StoryAfter 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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What is peer review really? (part 9 — it is really a crapshoot)

by Carl V Phillips

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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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