New Survey Shows Smoking Among Teens at Historic Lows And Dramatic Declines In Vaping

The National Youth Tobacco Survey results, released today by the Centers for Disease Control and Prevention (CDC), show that we are well on our way to finishing smoking for good. The dramatically low numbers of eight percent for past 30-day cigarette use by high school students, a decline of 1.3 percentage points from 2015 and a 4.7 percentage point decrease since 2013, are no accident and show the combined power of public-education campaigns targeted to youth, like truth® and the Food and Drug Administration’s (FDA) The Real Cost campaign as well as the CDC’s “Tips From Former Smokers.”

The data also show an incredible 4.7 percentage point decline in high school e-cigarette prevalence, now at 11.3 percent vs. 16 percent in 2015. While the number of high school students who use e-cigarettes is still too high, this rapid decline is a positive indicator that much youth e-cigarette use has been experimental and that the current offering of products may be less appealing to youth than feared. However, with rapid and continuous innovation in electronic nicotine products taking place, the results underscore the urgency for full implementation of FDA regulation of e-cigarettes to maintain this momentum in preventing all use of nicotine products by young people.

Despite this good news on a national basis, the total tobacco product use for high school students (20.2 percent) is still too high and the patterns of youth tobacco use across the U.S. remain very uneven. We must not forget there are many states in this country where the numbers tell a different story. Where you live, how much money and privilege you have makes a big difference in whether you smoke. The high school smoking rate in West Virginia is more than double the rate in California. LGBTQ young adults smoke at twice the rate of the average population, and individuals with mental illness account for 40 percent of cigarettes smoked in the U.S.

The data released today are another battle won for public health in the long effort to end the epidemic that still kills 540,000 people a year in our country. At the same time, it is no doubt an alarm for the tobacco industry who continue to spend $9.1 billion a year to market their deadly products and aggressively oppose federal, state and local efforts to curtail tobacco use. The industry now has added incentive to continue to adapt their products and tactics especially among their “best customers” in effort to find the more than 1,300 replacement smokers to fill the gap left by those who will die each day from tobacco-use. We have made significant progress in bringing both youth and adult smoking rates to historic lows. Now is the time to dedicate our efforts to making sure that no population or geography is left behind in our endeavor to claim what could be the most important public-health victory in modern times for our nation.

Air Sampling confirms secondhand vapor is harmless

Results obtained from an air sample of a small non-ventilated vape shop, clearly indicate that the amount of toxic substances present in the air where a lot of vaping is taking place, are of insignificant levels.

The California Department of Public Health has been carrying out air sampling in vape shops throughout the state, as part of its initiative to determine the health effects of second-hand vapor exposure.

Earlier today in his blog, Public Health Expert Dr. Michael Siegel pointed out that the results for this report were obtained from a relatively small and non-ventilated vape shop, where many of the employees and 13 customers were actively vaping while the sampling was taking place, hence what would be considered a situation presenting a high level of exposure to second-hand vapor. However, given all these unfavourable conditions, the results still reported no dangerous levels of exposure to any hazardous chemicals.

“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.”Dr. Michael Siegel 

The main results of the air sampling go as follows :

  • 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

Finally putting fears about formaldehyde to rest?

Dr. Siegel pointed out that the level of formaldehyde detected, is consistent with the levels normally found in indoor and outdoor air levels under baseline conditions.

Dr. Siegel pointed out that the level of formaldehyde detected, is consistent with the levels normally found in indoor and outdoor air levels under baseline conditions, adding that the only other chemicals detected were ethanol (alcohol) and isopropyl alcohol.

“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.” stated Siegel.

No justification for governments to ban vaping

“This study adds to the evidence that under real-life conditions, ‘secondhand vaping’ does not appear to pose any significant health risks.” concluded the public health expert. He added that whilst he himself has been behind many of the smoking bans that took place, based on this current evidence he fails to see a reason as to why governments should ban vaping in public spaces. “With regards to vaping, I just don’t see any reasonable evidence at this time that it poses any significant health hazard to bystanders.”

The war on e-cigs is now national

Hypocrisy has reached new heights, even by Washington’s standards. The same left-wing senators who support needle-exchange and methadone programs to reduce harm to drug addicts and demand condoms for high-schoolers are waging war against the most effective harm reducer of all — e-cigarettes.

Sens. Al Franken (D-Minn.), Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.) and other Democrats are demanding new FDA Commissioner Scott Gottlieb crack down on e-cigarettes without delay. Across the aisle, Sen. Ron Johnson (R-Wis.) is urging Gottlieb to examine the compelling evidence that vaping saves lives by helping smokers quit the deadly habit.  

Some 480,000 people in the United States die each year from smoking. But quitting is hard. E-cigarettes are far more effective than any patch, coach or gum at weaning addicts off their cancer sticks. And they’re diverting teens from even starting smoking.

But facts be damned. Senate Democrats are politicizing the issue, claiming that “special interests” lie behind the FDA’s decision to delay pending regulations drafted by the Obama administration.

The new regs, originally scheduled to go into effect by now, would compel all e-cigarette devices and flavors to be pre-approved by the FDA before being sold. The cost of pre-approval would crush all but the biggest producers. The Trump administration wisely put these rules on hold to look at the facts. Johnson wants the FDA to junk the regs altogether.

The FDA should be facilitating, not impeding, the use of e-cigarettes.

New research from the United Kingdom shows over half of UK e-cigarette users have quit smoking entirely. England’s most prestigious medical group, the Royal College of Physicians, endorses “large-scale substitution of e-cigarettes” for smoking. The country’s National Health Service urges patients who smoke to switch to vaping.

In Europe, 6 million ex-smokers report that e-cigarettes helped them quit, according to EU data, yielding impressive improvements in health. Smokers with hypertension who switch to vaping show significant decreases in systolic blood pressure after 12 months, better results than with medications. Asthmatics who switch from smoking to vaping gain better lung function and relief from coughing, reports Riccardo Polosa, director of the Institute of Internal Medicine and Clinical Immunology in Italy.

What about teens? Vaping isn’t a gateway to smoking in adults or teens, contrary to what the Democratic senators claim. But they prefer fearmongering to facts, accusing manufacturers of predatory marketing by luring adolescents with candy-like flavors.

In fact, vaping appears to be responsible for the dramatic drop in teen smoking since 2010, down more than 50 percent. Teens are vaping instead.  

Would it be better if they did neither? Yes, but human beings have been sticking things in their mouths since the beginning of time. Vaping is harm reduction.

That’s not the same as harmless. There may be traces of toxins, metals and carcinogens in vapor. But vaping is 95 percent less harmful than smoking cigarettes, researchers conclude.

The more smokers switch to vaping, the more lives will be saved.

As for secondhand smoke, it contains 60 carcinogens and is far more dangerous than the low levels of toxins in secondhand vapor.

New scientific evidence drawn from four countries — the United States, Canada, Australia and England — shows that the more restrictive a country’s vaping regulations, the less likely smokers are to put out their cigarettes and take up vaping. The FDA should heed this life-and-death information.

Both the European Union and the United Kingdom have set quality and safety standards for e-cigarettes without imposing a costly pre-approval regimen. The United States should do the same.

Millions of lives hinge on how the US regulates e-cigarettes. Sadly, the left is making it tougher for smokers and teens prone to smoking to choose the harm-reducing alternative.

Liberals have long mocked the “just say no” approach, but that’s what they’re telling smokers — that harm reduction is a good idea for heroin addicts but not cigarette addicts.

Landmark Vaping Study Finds E-Cigs ‘Substantially Improve’ Health

The Daily Caller | 5:36 PM 02/19/2017  

The push by U.S. regulators to crush the electronic cigarette industry may be slowing in the wake of a joint study with researchers from the United Kingdom revealing that switching to vaping considerably cuts health risks.

“You had researchers from both countries and the CDC involved in the planning and execution of the study for the first time,” Tony Abboud, executive director of the Vapor Technology Association, told The Daily Caller News Foundation. “One of the biggest findings of the study, was that if people switch from tobacco cigarettes to vaping products, their health is substantially improved than if they continued smoking.”

The study, published in the Annals of Internal Medicine, shows a large reduction in the levels of toxic chemicals and carcinogens linked to smoking-related illnesses in those who switched to vaping devices for at least six months. Researchers from University College London, Roswell Park Cancer Institute in New York and the Centers for Disease Control and Prevention (CDC) all participated in the landmark study, which refutes recent assertions from the surgeon general and CDC claiming vaping is harmful to health and a potential gateway to smoking addiction.

The U.K. actually promotes the sale of e-cigarettes as a health-conscious alternative to smoking, in stark contrast to U.S. policy.

“In the UK they’ve looked at all the science that exists and say vapor products are 95 percent safer than combustible cigarettes, and argue for that reason our government needs to be promoting them, not restricting them,” said Abboud. “That mindset, which is based upon science, is held across the board in England.”

The CDC released a report Dec. 8 condemning vaping as an unhealthy practice and warned vaping poses a significant risk to youth. Localities across the U.S. are implementing regulations treating vaping the same way as traditional cigarettes, with some measures slapping punitive the industry with taxes as high as 40 percent.

Despite the position of U.S. regulators, major health groups in England, like the Royal College of Physicians, agree that using e-cigarettes eliminates most of the harms attributed to smoking. They also recommend vaping to patients trying to quit traditional tobacco products. A study from Public Health England in 2016 found nearly all of the 2.6 million e-cigarette users in the U.K. are former or current smokers — many of whom are using the device to quit.

“Here in the U.S. we have a scientific community, or at least government agencies, that have pretended as if they don’t have enough information yet, despite one of the most esteemed medical bodies in the world, the Royal College of Physicians, coming to the conclusion they did,” Abboud told TheDCNF. “Those two things cannot be true.”

The vaping industry still faces an uphill battle against regulators, particularly from the Food and Drug Administration. The FDA passed a rule finalized in May forcing e-cigarette vendors to submit a pre-market tobacco application for each of their products. Under the FDA rule, vendors and manufactures will have until Aug. 8, 2018 to submit the applications for their products. Many are anticipating closure due to the application costs, which range from $100,000 to $400,000 dollars each.

Republican Rep. Tom Cole and Democratic Rep. Sanford Bishop introduced bipartisan legislation Thursday eliminating the onerous requirement from the FDA forcing manufacturers to submit products for approval that are already on the market. They argue this will help keep thousands of vendors and manufacturers in business.

Vaping Is Not a Gateway to Smoking, New Study Shows

Crack downs on vaping often use the idea of it being a gateway as justification.
Guy Bentley| January 9, 2017 

Reason.com

Vapers at the Virginia Commonwealth University were 3.4 times as likely to be smoking cigarettes a year later as young adults who were vape-free, according to the first-ever longitudinal study examining the progression of college students from vaping to smoking.

Researchers followed 3,757 freshmen for one year to discover if e-cigarette use at the baseline was associated with a progression from not smoking to trying a cigarette or currently using cigarettes at the follow-up.

The study, according to one the most die-hard e-cigarette opponents in the public health lobby today—Dr. Stanton Glantz—is yet another confirmation of the so-called 'gateway' effect of vaping. "The evidence just keeps piling up," proclaims Glantz.

The findings lead the study's authors to conclude that "limiting young adults' access to these products may be beneficial." In plain English, more age restrictions, vaping bans, and higher taxes are just the ticket.

But far from being the smoking gun finally proving e-cigarettes are a gateway to their tobacco-filled rivals, the study itself finds there is still absolutely no evidence of a gateway effect from vaping to regular cigarette use.

Dr. Michael Siegel, a professor in the department of Community Health Sciences, Boston University School of Public Health, points out the study's most relevant finding, totally ignored by Glantz:

"Current e-cigarette users at baseline were no more likely to progress to current smoking than young adults who were not using e-cigarettes."

So students who were vapers at the beginning were no more likely to become regular smokers than those who didn't use e-cigarettes at all.

"What this means is that all we know for sure about the young people who Dr. Glantz would have us believe have become smokers because of e-cigarettes is that they have at least once tried a cigarette, but that they have not smoked a cigarette in the past 30 days," writes Siegel. "So all these kids who Dr. Glantz would have us believe have been addicted to cancer sticks because of e-cigarettes are actually not current smokers."

The conclusion of the study's abstract also leaves out the finding that current vapers were no more likely than non-vapers to start smoking. Yet the authors arrive at the view that limiting young adults' access to e-cigarettes may be beneficial, despite failing to produce any evidence of a net public health harm from young people vaping.

Out of a sample of 3,757 students just six transitioned from vaping to smoking. But before anti-e-cig enthusiasts jump on this statistically insignificant number, Siegel points out that another 20 students who had used cigarettes at the baseline stopped smoking and were exclusively using e-cigarettes at the follow-up. A further 45 students who were dual users at the beginning were only vaping by the end.

Despite the very best attempts of Glantz and Co to push the 'gateway' narrative, reality is just not playing ball.

"For nearly a decade, anti-harm-reduction activists have been claiming that e-cigarette use would inevitably lead young people to become smokers," says Gregory Conley, President of the American Vaping Association. "The data is proving them wrong. As this study shows, young e-cigarette users may experiment with smoking, but that does not mean that these users are actually becoming smokers."

FDA Violated Ethics Rules to Censor Dissenting Opinions about Its E-Cigarette Regulations

tobaccoanalysis.blogspot.com | Friday, September 23, 2016

According to a shocking exposé in the October 16th issue of Scientific American written by Charles Seife, the FDA censored dissenting opinions about its e-cigarette regulations by prohibiting journalists covering the release of these regulations from speaking with anyone who might oppose them.

Second, the FDA prohibited the reporters at the media briefing from talking to anyone else about the regulations prior to the embargo, meaning that in the articles coming out about the regulations at the expiration of the embargo, there was no possible way for reporters to provide quotes from individuals who might have dissenting opinions about the regulations. In other words, the FDA ensured that only its own position could be presented to the public.

The article explains that reporters at the briefing were told: "You will not be able to reach out to third parties for comment on this announcement."

In addition, reporters were sent an email stating that: "Third-party outreach of any kind was and is not permitted for this announcement. Everyone who participated agreed to this. ... We take this matter very seriously, and as a consequence any individuals who violated the embargo will be excluded from future embargoed briefings with the agency."

The FDA thought that its little scheme to prevent the public from reading dissenting opinions about the regulations had worked to perfection. It apparently did work to perfection in terms of the nature of the media coverage, which of course failed to present any dissenting opinions from experts. However, one courageous reporter exposed the fact that the FDA was censoring media coverage by not allowing reporters to seek comments from experts who might have dissenting opinions. Inher article, she noted that:

"FDA officials gave journalists an outline of the new rules on Wednesday but required that they not talk to industry or public health groups until after Thursday's formal release of the document."

According to Scientific AmericanNew York Times

The FDA then blasted Tavernise in an email to her, stating: "I have to say while I generally reserve my editorial comments, I was a little surprised by the tone of your article and the swipe you took at the embargo in the paper—when after combing through the coverage no one else felt the need to do so in quite that way."

The FDA was apparently not only prohibiting reporters from presenting an alternative perspective on its regulations but also prohibiting them from informing readers that they werenot allowed to seek out alternative opinions. So the FDA was engaging not only in censorship but in a cover-up of that censorship.

At the time, Eric Boehm of Watchdog.org wrote about the FDA's censorship: "Essentially, the Times agreed to feed the public information about new regulations, but without being able to talk to any of the people affected by the regulations. What did that leave them in terms of perspective? Only those who favored the new regulations, of course."

According to Seife, the FDA is violating its own ethics policy, established in 2011, which states that: "A journalist may share embargoed material provided by the FDA with nonjournalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third party to uphold the embargo."

In a revealing section of his article, Seife explains that:

"Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story. At the same time, the FDA cultivates a coterie of journalists whom it keeps in line with threats. And the agency has made it a practice to demand total control over whom reporters can and can't talk to until after the news has broken, deaf to protests by journalistic associations and media ethicists and in violation of its own written policies."

Seife concludes that: "By using close-hold embargoes and other methods, the FDA, like other sources of scientific information, are gaining control of journalists who are supposed to keep an eye on those institutions. The watchdogs are being turned into lapdogs."

The Rest of the Story

In my view, this is a clear violation of scientific ethics as well as the public health code of conduct. This is something you might expect out of the playbook of Big Tobacco or other corporations, not out of a federal agency charged with protecting the public's health. 

Study Reveals E-Cigarettes Caused One Of The Biggest Falls In Smoking Ever

The Daily Caller | 12:00 PM 06/27/2016  

E-cigarettes are the principle cause of one of the biggest drops in smoking ever recorded, according to a new survey.

The study, published in the journal Addiction, shows more than six million Europeans have quit smoking and nine million have cut back using e-cigarettes.

Scientists from Greece and France came to the conclusion using data from the 2014 Eurobarometer on smoking and the use of electronic cigarettes.

The study’s authors say the Eurobarometer survey is one of the “most detailed ever used in analyzing electronic cigarette use on a population level.” The Eurobarometer survey is conducted by the European Commission, assessing all 28 member states of the European Union.

The study says 48.5 million Europeans have tried an e-cigarette and 7.5 million are current users. Of those currently using e-cigarettes, 35.1 percent have quit smoking altogether and an additional 32.2 percent have cut down the amount they smoke.

“These are probably the highest rates of smoking cessation and reduction ever observed in such a large population study,” said the study’s lead author, Dr. Konstantinos Farsalinos.

“The European Union data show that the use of electronic cigarettes seems to have a positive impact on public health for two main reasons: 1. High smoking cessation and reduction rates are observed, and 2. Electronic cigarette use is largely confined to smokers (current and former), with minimal use by non-smokers.”

Confounding fears of some public health activists, there’s little evidence non-smokers are taking up vaping in any significant numbers.

“In non-smokers we observed some experimentation with electronic cigarettes, but regular use is minimal. Just 1.3 percent of non-smokers reported current use of nicotine-containing electronic cigarettes and 0.09 percent reported daily use,” said Jacques Le Houezec, a neuroscientist at the French National Research Institute for Health and Medical Research.

The study’s findings dispute the “gateway” theory, which claims rising e-cigarette use could prove a transition to regular tobacco smoking.

“Practically, there is no current or regular use of nicotine-containing electronic cigarettes by non-smokers, so the concern that electronic cigarettes can be a gateway to smoking is largely rejected by our findings,” said Le Houezec.

Pro-vaping groups were delighted by the study’s findings, and viewed it as a vindication of the case for e-cigarettes as harm reduction tools.

“For over seven years, tobacco control activists have loudly proclaimed that there is no evidence that vapor products help smokers quit,” said Gregory Conley, president of the American Vaping Association.

“As the evidence supporting the efficacy of vaping has piled up, these activists have continually doubled down on their denialist attitudes. In the process, the anti-harm-reduction camp has embraced worse and worse science to support their outdated views.

“Worldwide, vaping has undoubtedly helped over 10 million smokers quit.  In the same year, this study was conducted, a similar population-level survey was performed in the United States.  That 2014 study found that 2.4 million adults had quit smoking with vapor products. Here in 2016, that number has almost certainly risen past 3.5 or 4 million quitters in the U.S. alone.”

Conley urged tobacco control activists to heed the advice of bodies such as the Royal College of Physicians (RCP) and Public Health England, who have been vocal about the potential benefits of e-cigarettes as a method to help smokers quit.

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New Study on Asthma and Vaping: Long-term benefits

"Persisting long term benefits of smoking abstinence and reduction in asthmatic smokers who have switched to electronic cigarettes" - is the title of a study conducted by the research group led by Prof Riccardo Polosa at the University of Catania, and recently published in Discovery Medicine.

The asthmatic smoker represents a distinct disease phenotype, with increased susceptibility of exacerbations and poor asthma-specific health. Increased disease severity and marked impairment in asthma control is more frequently reported in people with asthma who have smoked more than . Most studies show an accelerated decline in lung function and increased airflow obstruction and even worse, asthma patients who smoke appear to have a reduced response to anti-asthma drugs, compared to asthmatics who do not smoke.

Although quitting smoking can reverse the negative impact of tobacco smoke on asthma symptoms and lung function, many smokers will keep smoking, because when given only the options of smoking or completely giving up nicotine, many will not give it up.

The group hypothesized that electronic cigarettes could not only assist asthmatic smokers to quit, but they could also contribute to harm reversal of subjective and objective asthma outcomes.

The research group investigated changes in the health status and respiratory function of 18 smokers with mild to moderate asthma who quit smoking by switching to daily electronic cigarette use. Baseline measurements were taken prior to switching and were compared with those obtained at 6, 12, and 24 months follow-up visits.

Long-term monitoring of respiratory symptoms, lung function, airway hyper-responsiveness, asthma control, asthma exacerbations and tobacco consumption in daily electronic cigarette users with asthma is of great importance to patients, consumers, manufacturers, health professionals and policy makers. “Significant improvements in respiratory symptoms and lung function have been consistent” - noted the lead author of the study, Prof Riccardo Polosa - with similar positive results being reported in dual users, that is, those who smoked and vaped simultaneously".

Polosa says that switching to daily use of electronic cigarettes may ameliorate clinical, functional and therapeutic outcomes for many asthma patients who smoke and that beneficial effects persist in the long-term. According to the researchers, the use of electronic cigarettes can even reverse the damage caused by tobacco smoke in asthma patients who smoke. Of note, deterioration in methacholine PC20, lung function, ACQ scores and exacerbation rates was noted in the two patients who relapsed to exclusive tobacco smoking.

Quitting smoking is an essential step for asthma patients, crucial for the effective treatment of their disease. However it is not always easy for them. In these cases, a less harmful alternative to tobacco smoking can be a valid option. This evidence-based notion that substitution of conventional cigarettes with electronic cigarettes is unlikely to raise significant respiratory concerns can improve counselling between physicians and their asthmatic patients, who are using or intend to use electronic cigarettes.

FDA’s deeming regulations: Public health in jeopardy

The FDA's finalized deeming regulations are not only deleterious for the vapor industry but also a tragedy for public health.

Jérôme Harlay
Vaping Post | 2016-05-06T12:09:12+00:00

Smoking kills a bit less than half a million Americans each year, equivalent to the total amount US GIs dead during WWII, a truth that cannot be ignored by the FDA.

But despite this established fact, FDA released its deeming regulations for a product that was endorsed by the British Royal College of Physicians as a harm reduction option. A non-official release that was termed in our lines a “low blow” for the US vapor industry but that in fact is a series of lousy tricks towards industry and public health.

One day after its release, experts looked into the 499-page document and started distilling their comments and analyses. The effective date of the regulations will be approximately August 10, 2016, since the official document is supposed to be published in the Federal Registry by May 10.

One of the most striking points of the document despite the bipartisan Cole & Bishop amendment that could have changed the deal, is the uphold of the predicate or grandfather date on February 15, 2007. Regarding this date, the FDA stated that it does not have authority to change it, and from this statement on, a deleterious cascade of outcomes.

A brief historic point

The e-cigarette business is a consumer driven market that was born in the early 2000s and has becomes one of the most popular, because e-cigarette is one of the most enjoyable alternate to combusted tobacco.

The idea came to a Chinese pharmacist who developped a device that supplies nicotine and provides comparable feelings than smoking without the tar, the huge carcinogenic load and the bad combustion gases. Vapor, that is what the e-cigarette produces. A vapor that is enriched with nicotine and flavored over a wide range of fragrances from tobacco to fruity cocktails.

A bright idea except the name that the product was given, in analogy to its carcinogenic sibling. Since then, the e-cigarette has been under fire. The term “personal vaporizer” that is also used for the device would have probably been more adapted.

The PMTA and FDA’s approval

One of the consequences of the uphold of the predicate date is that most (some people argue 99%, which is probably close to the truth) of the manufacturers will have to request a FDA’s agreement to continue their business. This agreement is requested in the form of a Pre-Market Tobacco Application (PMTA).

FDA’s approval of a PMTA is mandatory for each product, e-liquid of hardware. If a manufacturer declines its flavored e-liquid in three different nicotine strengths, it will be requested to file three PMTA, one for each strength. And the FDA will also have to process the applications in due time…

As described by Patricia Kovacevic in the webminar she held on FDA’s deeming regulations, the PMTA pathway is burdensome and costly. It applies to every device and product that a manufacturer marketed after February 15, 2007.

If a product and/or device can be shown to be “substantially equivalent” (SE) to a product that was distributed before February 15, 2007, a predicate, it can escape the most burdensome and costly pathway.

A benefit for public’s health

The “questions of public health” are central to the problem since manufacturers will have to demonstrate that the SE product is not only similar to its predicate but also raises no “questions of public health”. For products that, by design, has major public health implications, it fatally leads to the bureaucratic bottleneck of PMTA pathway.

The notion of “risks and benefits” will be taken into consideration by the FDA to evaluate the overall benefit for public’s health.

And this includes not only the benefit for smokers but also the risk for anyone exposed to what is produced by the device (directly or indirectly) or who may be handling the object. With the largely advertised debate on PG or flavorant toxicity, nicotine dangerousness upon contact or ingestion and the risk of deflagration, there is a lot of room for deeming an e-liquid or an e-cigarette not compliant with such a rule.

In summary, the manufacturer will have to adroitly balance the risks to non-vapers by the benefits to vapers in order to overcome this aspect of the procedure.

The regulations also provides that, except if the approval of a PMTA is obtained in between, no new vaping products or e-liquids will be allowed on the market from August 2016 on.

Michael Siegel, in his analysis, roughly estimates to $300,000 the cost for the manufacturer to file a single PTMA, a procedure that the FDA recognizes as a 1,500-hour labour. A back-of-the-envelop calculation gives a $20-million capital cost for a manufacturer aiming at authorizing 20 flavors in 3 nicotine strengths.

Based on these figures, a huge decrease in the variety of e-liquids is expected in stores, mainly favorizing the larges companies and sweeping out the smallest ones.

In a recent article, a market analysis revealed that the US market for e-liquids remains fragmented (532 brands of e-liquid) while the hardware market is much more consolidated (52 brands of tanks and atomisers, and 42 brands of mods), mid-2015. Averaged monthly store revenue approached $25,600 for an annual estimate per vape store location of $300,000.

Unconstitutional as it violates the free speech rights of vaping manufacturers

Michael Siegel considers unconstitutional the fact that manufacturers will not be allowed to make modified risk claims, in accordance with the deeming regulations and that companies cannot even describe their products as a “smoke-free” alternative to smoking.

He explains that it may force the manufacturers into a discourse that may discourage vapers from purchasing their products because manufacturers:

Listing Potentially Harmful Aerosol Constituents

In a close future (within 3 years of the effective date), a Listing of Potentially Harmful Aerosol Constituents will be requested by the FDA for each e-liquid. This is a request that imposes an analytical expertise of the aerosol produced by every single flavor or variation.

Michael Siegel judges this requirement superfluous because a manufacturer can’t submit a PMTA without providing this information anyway. Nevertheless, it is only the tip of the iceberg. From an analytical point of view, this requirement also implies that protocols for aerosol analysis are setup and approved by the FDA. Scientific literature shows that several laboratories are in the front line for such an analysis, and especially the Big Tobacco R&D departments.

To date, laboratories are using different analytical settings (GC, SESI, PTRMS…) to analyze e-cigarette vapor’s quality, none of them has established  robust protocol yet and limitations remain on:

  • smoking machine settings and performance to reproduce the vaping profiles of users ranging from neophyte to expert vaper,
  • detection levels depending on the type of analysis employed to determine the concentration of each molecule,
  • the reference unit to express the concentration…

There are many analytical constraints that remain to be clarified to obtain a consensus and it is hardly believable that such a challenge may be addressed rapidly in such a controversial context.

Is there a last resort?

“The FDA has done a huge favor for the continued strength of cigarette consumption in the United States.” -M. Siegel

Beyond the disaster for the vapor industry, the regulation is also a disaster for public health, according to Siegel’s words. For the expert, only Congress would be able to enact legislation that prevents the FDA from requiring PMTAs for vaping products and to force the FDA instead to develop actual safety standards for these products.

The Smoke-Free Alternatives Trade Association (SFATA) issued a statement after the release of the Deeming Regulations to ask the Congress to take action so that vapor products remain on the market as highly effective replacement tools for smokers. Their position to change the predicate date is, in their word, “the only viable option”.

The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) recalls that FDA has placed the rule in the Federal Register “Public Inspection File” pending publication in the Federal Register, earliest on Tuesday, May 10. The association reassures its members that there is no emergency in acting but that it is “not the end of the process”. They request more time carefully analyze the document.

The Vapor Technology Association (VTA) calls the FDA’s final deeming rule on e-cig and vapor regulations a “one-size-fits-all approach” and condemns the FDA for its tardiness. The association considers that the FDA falls “behind the rest of the world for the development of product standards” and feels that their joint effort with the European Committee for Standardization (CEN) to establish product and business standards are not echoed by the Agency.

“Harm reduction advocates have long warned that FDA ‘regulation’ of vapor products would resemble prohibition far more than reasonable regulation. Today, these warnings became reality.  The FDA’s refusal to modernize the February 2007 predicate date will cause a modern day prohibition of products that are recognized worldwide as far less hazardous than cigarettes” declared Greg Conley, President of the American Vaping Association (AVA) who raises the question of a potential open door to a black market if the Congress or the courts do not counteract the present ruling.

A black market that may come from the prohibition era that has just been created and that has been naively tested by Clive Bates as amazingly demonstrated on his blog the day before the release.

Doctors Back Vaping In Battle With FDA

As mainstream support begins to grow for vaping, another group of doctors is calling for the FDA to acknowledge the benefits vaping has on smoking cessation.

Seven top international tobacco control experts have come together to release an article in the renown medical journal Addiction that outlines the advantages of vaping, with an aim at encouraging the regulators at the United States Food and Drug Administration to have an open mind when it comes to their proposed regulation of vape products. The group, led by David T. Levy, Ph.D. of Georgetown University, released the report earlier this week and has since been picked up by ScienceDaily and The San Diego Union-Tribune.

The group of tobacco experts found that through their data analysis, which covered the years since vaping was introduced to the public, found that vaping has drastically reduced the number of active smokers in the United States and worldwide. The findings, which were pooled together using various studies done since 2007, show that although smoking is still a significant problem, the introducing of vaping products has actually helped improved the numbers of smokers who quit smoking traditional cigarettes for good.

In an article posted on The Daily Caller, David Levy, who is a professor in the Oncology Department at the Georgetown Lombardi Comprehensive Cancer Center and lead expert on the study, released a statement that read in part, “We’re concerned the FDA, which has asserted its right to regulate e-cigarettes, will focus solely on the possibility that e-cigarettes and other vapor nicotine products might act as a gateway to cigarette use.”

The FDA has indeed taken control over the regulation of vaping products. However, earlier this month, the House Appropriations Committee, which has jurisdiction over the vaping industry matter, voted to amend the predicate date set for by the FDA to a more recent date, allowing vape companies and businesses to be grandfathered into the law that would see all new products to go through a pre-review process before hitting the marketplace.

This review process is expected to cost a million dollars for every new product, and with the former predicate date of February 15, 2007, would have rendered nearly every business on the market invalid, effectively shutting down the industry within the US.

However, as the House Appropriations Committee moves to have the amendment voted on the floor of both the House and the Senate, vaping advocates continue to push for the FDA and other public health agencies to discuss the positive effects vaping has had on the public, warning that by punishing the vape industry with strict regulations and high taxation is counter intuitive to the goal of eliminating smoking once and for all.

“Increasing e-cigarette prices by taxing them the same way as cigarettes will discourage youth VNP use, but also discourage use by smokers, especially those of lower socioeconomic status, who are trying to quit,” Levy said in the conclusion of the study.

Why is this study important? The study shows that a variety of international experts, including experts from Australia, Canada, and other countries, have come together to the same conclusion — that the vaping industry is in need of encouragement from medical organizations. Although much is still left to be learned about the effects of vaping, one thing is certain — dismissing it as a form of alternative treatment to smoking cessation is a dangerous tactic, and should be avoided at all costs.