FDA Chief may have just threatened vaping a 42-word tweet

As rumors of a possible FDA ban on flavored e-liquids spreads across the vaping industry, an eerie tweet from the agency’s Commissioner Scott Gottlieb is getting a great deal of attention.  Posted on February 17, Dr. Gottlieb seems to be issuing a warning to American vapers.  Stop underage vaping or face the consequences.

In just 43 short words, the vaping community gets an inside look into the mind of the FDA Chief regarding the possible future of vaping.  The tweet in question simply states the following.

“Adults can’t favor preserving properly regulated e-cigarettes as an alternative for smokers who quit combustible tobacco, and not at same time vigorously oppose child access to e-cigs. The industry isn’t sustainable if it leads to a whole generation of youth initiation on tobacco”

Vapers had high hopes when Trump tapped Gottlieb to run the U.S. Food and Drug Administration.  Gottlieb had been a previous major investor in the KURE e-cig company, and he was also said to be very close friends with pro-vaping Jim O’Neill of NJOY fame.

Related Article:  Scott Gottlieb: Trump’s FDA pick has strong ties to Big Pharma and GlaxoSmithKline

But his close ties to Big Pharma led some vapers to more cautious about the new commissioner right from the start.  Gottlieb has also been a paid consultant for GlaxoSmithKline, one of the world’s largest and most politically powerful pharmaceutical companies and a leading manufacturer of more conventional nicotine replacement therapies (NRTs) like the patch and nicotine gums.

The Gottlieb tweet may be significant

The vaping community is somewhat divided on the issue of teen vaping.  Some vapers have very strong feelings about retailers peddling e-liquids and vape mods to kids.  Others feel that the allegations surrounding teen vaping have been grossly exaggerated by anti-tobacco groups and mainstream media.

Meanwhile, the issue of “vaping as a gateway to teen smoking” also ruffles the feathers of many American vapers on both sides of the argument.    Study after study seemingly indicates that the reverse is true:  teens who experiment with vaping rarely evolve into long-term smokers. Even a recent CDC report seems to refute the gateway theory.

Related Article: Did the CDC just confirm that vaping is NOT a gateway to teen smoking?

So, when the FDA Commissioner starts talking about teen vaping in news conferences, in publicly issued press announcements, or on Twitter, it can be very easy for some vapers to turn a blind eye and assume that this is just more anti-vaping propaganda designed to placate the masses.  But are American vapers wrong?  Is the Gottlieb tweet a warning sign that things are about to get really and truly ugly, especially regarding a possible flavor ban?

As more and more cities like San Francisco and Berkeley, California, propose local legislation that prohibits the sales of flavored e-liquids, federal public health officials are also taking note, including FDA Chief Scott Gottlieb.  The public outcry against vaping seems to be escalating, and the vaping community should probably start fighting now to protect their rights to buy cotton candy and bubblegum flavored e-liquids before it’s too late.   

from VAPES – News https://www.vapes.com/blogs/news/fda-chief-may-have-just-threatened-vaping-a-42-word-tweet

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Did the American Cancer Society just endorse vaping?

The American Cancer Society has had a long and contentious relationship with the vaping industry.  When the U.S. Food and Drug Administration (FDA) first released its controversial deeming regulations in mid-2015, the ACS was fully supportive.  When the Cole-Bishop Amendment to redefine the FDA deeming regulations was attempting to make its way through the congressional approval process last year, the ACS refused to endorse it.  In fact, some representatives of local chapters publicly denounced the proposed amendment, calling it the “latest trick” to avoid federal oversight.

Related Article:  American Cancer Society Rep lies about Cole-Bishop Amendment to FDA e-cig regulations

But when the ACS released a new position statement on electronic cigarettes this month, the document appears to endorse vaping as a tobacco harm reduction tool at first glance.  Has the ACS finally come around to notion that vaping is significant healthier than smoking, a notion that is supported by reams of scientific evidence? 

“Based on currently available evidence, using current generation e-cigarettes is less harmful than smoking cigarettes, but the health effects of long-term use are not known.  The American Cancer Society (the ACS) recognizes our responsibility to closely monitor and synthesize scientific knowledge about the effects of all tobacco products, including e-cigarettes and any new products derived from tobacco.  As new evidence emerges, the ACS will promptly report these findings to policy makers, the public and clinicians.”

While the ACS seems to be publicly endorsing vaping for smokers trying to quit, the agency leaves open a loophole to change its mind in the future.  The ACS says it will “closely monitor” the e-cig industry and make new recommendations to public health officials and the general public as “new evidence emerges.”

American Cancer Society recommendations to physicians

Regarding the FDA deeming regulations, the ACS position statement also offers some insights.  While the deeming regulations are not specifically addressed in the document, a considerable amount of space is devoted to the ACS’ views on FDA oversight.

“The ACS encourages the FDA to regulate all tobacco products, including e-cigarettes, to the full extent of its authority, and to determine the absolute and relative harms of each product.  The FDA should assess whether e-cigarettes help to reduce tobacco-related morbidity and mortality, and the impact of marketing of e-cigarettes on consumer perceptions and behavior.  Any related regulatory regime should include post-marketing surveillance to monitor the long-term effects of these products and ensure the FDA’s actions have the intended health outcome of significantly reducing disease and death.  Furthermore, the FDA should use its authorities to reduce the toxicity, addictiveness and appeal of tobacco products currently on the market.”

The position statement also indicates a considerable level of ACS support for the implementation of public health policies and new sin taxes geared towards the prevention of initiating in tobacco use, especially among young people.  And while the document pushes the FDA towards conducting more studies on the long-term effects of vaping, it also pushes that age-old argument that e-cig use among teens is a gateway to future smoking addiction. 

“Furthermore, evidence indicates that young e-cigarette users are at increased risk for both starting to smoke and becoming long-term users of combustible tobacco products.”

The American Cancer Society appears to be somewhat softening its public stance on the tobacco harm reduction benefits of vaping, but the newly released position statement still does not represent vaping in the best light possible.  In once section, the ACS even “applauds the FDA” for its role in vaping research and regulations while also endorsing FDA Commissioner Scott Gottlieb’s latest proposal to introduce additional regulations that would limit the amount of nicotine in combustible tobacco products.

So far, the nicotine reduction proposal does not affect electronic cigarettes and e-liquids. Instead, the FDA seems to be showing signs of a possible ban on e-liquid flavors other than tobacco.   The ACS position statement does not address this issue specifically.  At least, not yet.

Related Article:   FDA Chief Scott Gottlieb issues new statement of vaping products

 

from VAPES – News https://www.vapes.com/blogs/news/did-the-american-cancer-society-just-endorse-vaping

Cancer death rates drop sharply as vaping soars in popularity, says new report

While cancer death rates have been on the decline for nearly thirty years, recently published statistics indicate a significant drop in the last five years coinciding with the rise in popularity of vaping.  According to data provided by the American Cancer Society (ACS), national cancer rates plummeted by 350,000 saved lives in 2014 alone.  Over the past three years, rates plummeted by 1.7 percent.  These figures are rather astonishing when compared to the 1991 data indicating that an estimated 26 percent of new cancer diagnoses would eventually turn fatal.

The findings published in the ACS report were compiled from information obtained by physicians and oncologists across the country.  The primary objective of the study is to understand more clearly which factors increase the risks of terminal cancer and, alternatively, which factors can limit the threats.

The report entitled Cancer Statistics 2017 does not specifically discuss vaping, but it does credit the massive movement to end smoking currently taking place in American.  The ASC estimated that over two million lives have been saved over the past twenty years simply because the general public has been made more aware of the dangers of smoking.

Research shows vaping is helping to reduce cancer death rates

The ACS has had a contentious relationship with vaping over the years.  The national organization tends to lump vaping into the same category as smoking, perhaps in an attempt to follow the lead of the FDA which classifies both as tobacco products per its deeming regulations of 2015.  The ACS is usually very careful not to endorse vaping, citing the need for more research before an official recommendation or denouncement can be released.  In some cases, local representatives have even issued anti-vaping statements to the press.

Related Article:  American Cancer Society Rep lies about Cole-Bishop Amendment to FDA e-cig regulations

But a recent vaping study conducted by the University of California (UC) supports the idea that vaping is an essential contributing factor to the decline in cancer death rates.  The UC vaping study entitled E-cigarette use and associated changes in population smoking cessation: evidence from US current population surveys published on the BMJ website states that the recent rise in popularity of vaping over the past five years and the coinciding declines in cancer-related deaths are not a mere coincidence. 

“The substantial increase in e-cigarette use among US adult smokers was associated with a statistically significant increase in the smoking cessation rate at the population level. These findings need to be weighed carefully in regulatory policy making regarding e-cigarettes and in planning tobacco control interventions.”

The UC study also indicates that an estimated 65 percent of smokers who transition to vaping, even if they happen to partake in dual use for a short period, are far more likely to quit smoking altogether compared to only 40 percent of smokers who try to quit through more traditional methods.

The ACS findings are also mirror those of a recent 2017 report on national smoking rates published by the U.S. Centers for Disease Control and Prevention (CDC).  The CDC study entitled Tobacco Use Among Middle and High School Students – United States, 2011-2016 shows that teen smoking rates in particular are at an all-time low, dropping to only 4.8 percent in 2016. While the official report does not specifically claim that teen vaping is not a gateway to smoking, the figures certainly seem to substantiate this idea.    

Related Article:  Did the CDC just confirm that vaping is not a gateway to teen smoking?

from VAPES – News https://www.vapes.com/blogs/news/cancer-death-rates-dropping-as-vaping-soars-in-popularity-says-new-report

Nicopure appeal over FDA deeming regs moves forward; opening briefs filed

The National Law Review is reporting that attorneys for Nicopure Labs and the Right to be Smoke-Free Coalition have filed opening briefs to appeal the July 2017 decision in their lawsuit over the FDA deeming regulations.  Last year, Judge Amy Berman Jackson of the Federal District Court in Washington D.C. the issued a 93-page decision in favor of the FDA.  The plaintiffs (appellants) disagree with Berman’s decision and filed an appeal based on two primary arguments.

Related Article:  Vaping takes a hit: Judge rules in favor of FDA in historic Nicopure lawsuit

Firstly, the Modified Risk Tobacco Product (MRTP) provision of the Tobacco Control Act (TPA) prohibits vape shop owners and employees from providing their customers information regarding the tobacco harm reduction benefits of vaping.  Retailers are also prohibited from offering free e-liquid samples.  Nicopure Labs and the Right to be Smoke-Free Coalition argue that the new restrictions violate the first amendment right of free speech.

Related Article:  Nicopure makes history; files first lawsuit over FDA e-cig regulations

Secondly, the appellants believe that the Pre-Market Tobacco Application (PMTA) process should not apply to vaping products.  Because the FDA deeming regulations now classify e-cigs as tobacco products, vape retailers are now forced to adhere to the same approval process as Big Tobacco, even though e-liquids are 100% tobacco-free.

Related Article:  Nicopure Labs v. FDA: Judge hears oral arguments in historic lawsuit over deeming regulations

The appellants are not opposed to an application and approval process, but they would like to see one that is specifically designed for the vaping industry.  They consider the current PMTA process to be far too complex, time-consuming, and expensive for the average vape shop owner.  Nicopure Labs and the Right to be Smoke-Free Coalition further argue that the FDA deeming regulations in their current state will essentially wipe out nearly 95 percent of the vaping industry as soon as they go into effect.  

(We will keep you updated as the appeal process continues forward.)

Related Article:  Federal judge consolidates historic lawsuits: Nicopure Labs vs. FDA e-cig regulations

from VAPES – News https://www.vapes.com/blogs/news/nicopure-appeal-over-fda-deeming-regs-moves-forward-opening-briefs-filed

Metallic toxicity of e-cig vapor similar to everyday air, says vaping study

Anti-vaping lobbyists often claim that the vapor from e-cigs vapor may be just as deadly as the second-hand smoke from combustible cigarettes.  Many have also tried to link vaping to allegedly causing popcorn lung while others have spread the false report that vaping propylene glycol is tantamount to vaping antifreeze.  Both accusations are proven to be totally false.   Now, a recent study conducted by scientists from two American universities debunks the myth that vaping is just as metallically toxic as conventional cigarettes. 

Led by Dr. Dominic Palazzolo of Tennessee’s Lincoln Memorial University (LMU) in accordance with researchers from LMU and William Carey University (WCU) of Missouri, the research team set out to measure the levels of multiple trace metals found in e-cig vapor while comparing them to those of combustible cigarette smoke.  After monitoring for an extensive list of metallic toxicities including arsenic, aluminum, cadmium, copper, iron, manganese, nickel, lead, and zinc, the scientists concluded that the amounts of trace metals found in e-cig vapor is no more than that of normal, everyday, ambient air in most cases.

Overview of the vaping study on metallic toxicity

The Palazzolo study entitled Trace Metals Derived from Electronic Cigarette (ECIG) Generated Aerosol: Potential Problem of ECIG Devices That Contain Nickel is readily available via the Frontiers in Physiology website.  As a basis for comparison, the researchers measured the toxicity levels produced from an e-liquid with a nicotine concentration of 7ml vaped at normal temperatures that did not exceed 350 degrees Celsius.  The second-hand smoke was produced from a typical Marlboro cigarette purchased locally.

Related Article:   More benzene found in every day air than in e-cig vapor, says new PSU study

There were, however, slightly higher levels of nickel found in the e-cig vapor as compared to ambient air.  The co-authors of the study suggest but do not confirm that this extra nickel may be from the vaping coil of the device itself, but the increase levels do not pose a significant health threat.

“In general, the findings of this study suggest that the concentrations of most trace metals extracted from cigarette smoke exceed the concentrations of trace metals extracted from ECIG-generated aerosol. While confident of these findings, it must be emphasized that these results are specific to the single ECIG device/E-liquid combination used. Nevertheless, a possibility for significant trace metal inhalation exists depending on the brand of ECIG device used. The present study illustrates this point. Given that Ni in the E-liquid is nearly undetectable, the source of Ni in the aerosol must be the ECIG device. From this study, it is unlikely that the ECIG-generated aerosol contains enough of the other trace metals to induce significant pathology.”

As if anticipating backlash from the anti-vaping community, the co-authors also go into significant detail as to why their findings do not mirror those of previous research which suggests that vaping is more highly toxic.  They note that in previous studies, the researchers either intentionally or accidentally escalated the vaping temperatures to levels that would be uncomfortable or distasteful for the vaper. In doing so, they may have heated the coil of the vaping device too high, which likely resulted in the increased metallic toxicities measurements.   

Related Article:   Vaping study from California DOH debunks ‘popcorn lung’ myth

from VAPES – News https://www.vapes.com/blogs/news/metallic-toxicity-of-e-cig-vapor-is-similar-to-everyday-air-says-vaping-study

As Norway legalizes vaping, possible snus ban gains traction

Norway public health officials released a new report citing a dramatic decline in smoking rates in recent years, but snus use is apparently on a massive uptick.  Government officials in one of Trump’s favorite nations have been aggressively trying to wipe out smoking nationwide for years.  New statistics indicate that they may be winning the battle, but the war is not yet over. 

The good news is that smoking rates among young women ages 16 to 24 is almost nonexistent.  Only 1% of this demographic currently smoke, down from 30% in 2001.  Smoking rates among young men plummeted from 29% to only 3% respectively.

Related Article: Smoking rates plummet to 10-year low, thanks partly to vaping, says UK

The tradeoff is a significant rise in snus use. Even among young women, snus use has grown from 5% to 14%.  In nearby Sweden, approximately 20% of the population are daily snus users while then nation’s smoking rates have dropped to under 5% overall.

The snus issue is such a major concern among health officials that the European Court of Justice is entertaining arguments to ban snus products completely.  One court filing is being spearheaded by a consumer advocacy group named the New Nicotine Alliance.  A spokesperson for the organization issued the following statement

“Any reasonable person looking at the spectacular graph for smoking among young Norwegians will be struck by how the fall accelerated after snus became available in 2002. This is no fluke. The end of smoking is in sight in Norway and Sweden as people choose far safer snus instead. So reasonable people will ask why the UK government decided to urge the European Court of Justice to maintain the snus ban in the rest of the EU.”

Pro-vaping enthusiast Dr. Konstantinos Farsalinos from the Onassis Cardiac Surgery Centre in Athens, Greece also seems to be in support of a European snus ban.  In the same press release, Farsalinos issues the following comment.

“There is absolutely no doubt that access to snus in Sweden and Norway has played a crucial role in the rapid reduction of their smoking rates.”

Vaping in Norway

Norway has somewhat loosened its grip on anti-vaping regulations. In December of 2016, Norway’s Parliament passed the Tobacco Act which was primarily designed to comply with the Tobacco Products Directive (TPD) regulations of the European Union (EU).  Bent Høie, the country’s Minister of Health and Human Services, called the new legislation “an important milestone in the work for a tobacco-free generation”. The new laws take effect this spring. 

Related Article:  Clive Bates: TPD Article 20 is ‘defacto protection’ for Big Tobacco

At approximately the same time, Høie lifted the prior nationwide ban on electronic cigarettes.  In a public statement, he claims that vaping devices “have less damage potential than tobacco smoke.”  However, e-cigs will remain banned in places where smoking is prohibited.  Høie also falls short of endorsing vaping entirely, citing “a very limited knowledge” and scientific evidence on the health benefits of vaping.

This statement is considered somewhat odd in some European vaping circles, particularly since the UK’s Public Health England has publicly stated since 2015 that e-cigs are 95% less harmful than smoking.  But England is no longer a member of the EU, thanks to last year’s Brexit vote.  So perhaps this research carries less wait with political officials across the rest of Europe. 

Related Article:  UK blasts Surgeon General; Calls vaping ‘a great public health opportunity’

 

from VAPES – News https://www.vapes.com/blogs/news/as-norway-legalizes-vaping-possible-snus-ban-gains-traction

DNA damage from vaping is 96% less than smoking, says Big Tobacco study

A controversial study published last week by New York University researchers implies that vaping causes just as much DNA damage as smoking.  The scientists claim to have come to this conclusion by exposing mice to e-cig vapor.  They also claim that vaping caused a reduced production of XCP and OGG1/2 proteins which consistently repair lung tissue in the body.  Critics argue that the NYU scientists intentionally cranked up the vapor levels to abnormally high levels that no typical vaper would ever inhale. 

This is not the first time that the vaping industry has fallen victim to the spreading of bogus research.   The issue of vaping and DNA damage has been raised several times in the past.  In fact, a 2016 study led by Linsey Haswell of British American Tobacco (BAT) suggests that vaping causes as much as 96 percent less DNA damage compared to smoking.

British American Tobacco, by the way, is a manufacturer of such well-known combustible cigarette products as Lucky Strike, Pall Mall, and Dunhilll brands.  For Big Tobacco to publish an e-cig study that essentially paints their entire industry in a bad light is truly noteworthy.  Although, it should also be noted that the research was originally intended to promote their iQOS Heat-not-Burn technology. 

Overview of the Vaping & DNA study

The BAT study entitled Reduced biological effect of e-cigarette aerosol compared to cigarette smoke evaluated in vitrousing normalized nicotine dose and RNA-seq-based toxicogenomics is published on the Nature website.  Instead of using live animals for their experimentation, the Haswell team constructed a three-dimensional computerized model of the human respiratory system. 

The researchers then exposed the airway passages to both the second-hand smoke from combustible cigarettes and the second-hand vapor from electronic cigarettes.  But unlike the former study, both the smoke and the vapor had comparable levels of nicotine. 

Related Article:  New U.S. research: Smoking causes damage to DNA that can last 30 years

The scientists also measured the associated responsivity rates of nearly 1000 different genes.  They then monitored several biomarkers, including the following.

  • Apoptosis
  • Biosynthetic processes
  • Extracellular membrane pathways
  • FNA damage signaling
  • Genesest and GO functional annotations
  • Hypoxia
  • Metabolic/biosynthetic processes
  • Multiple genotoxins and non-genotoxins
  • Oxidative stress response rates
  • qPCR
  • RNA isolation
  • RNA-seq

What the BAT scientists determined is that smoking causes immediate and measurable DNA damage in some 876 genes within a 24-hour period after smoking.  Another 204 genes undergo some degree of genetic mutation within 48-hours.   Meanwhile, the e-cig vapor negatively impacted a total of only 4 genes during the same timeframe, for a 96.4 percent reduction in DNA damage compared to smoking.

“In vitro testing evidence, however, support the view that vaping causes less damage to cell systems when compared to smoking. Examples of robust in vitro assessment studies of novel nicotine delivery devices (heated tobacco products and e-cigarettes) have used a relevant cell model, a well-considered exposure strategy combined with holistic untargeted omics screens to comprehensively assess the biological perturbations.”

The researchers also attempted to identify which types of possible illnesses or disease might be caused from the associated genetic mutations and damage.  According to their findings, the DNA damage caused from smoking most closely resembles that which is associated with heart disease, lung cancer, fibrosis, and numerous respiratory disorders. 

Related Article:  New study shows vaping has no effect on ‘respiratory toxicity’ of the lungs

 

from VAPES – News https://www.vapes.com/blogs/news/dna-damage-from-vaping-is-96-less-than-smoking-says-big-tobacco-study