Stop demonising a potentially useful product for smokers

As Seen in The Pharmaceutical Journal|10 SEP 2014By Clive Bates

Compulsory regulation of electronic cigarettes could spoil a safe substitute for smoking.

Source: christophkadur / Shutterstock.com

Electronic cigarettes are becoming more popular but are not licensed as medicines

The market for electronic cigarettes is rapidly growing and no proof of serious health risks associated with their use has so far emerged. Much of the media coverage has focused on the risks and potential downsides of these products. We must take a step back from these unfounded fears and consider e-cigarettes in a different light.

E-cigarettes offer a powerful response to the grotesque burden of disease caused by smoking, something that should excite anyone interested in public health. They provide a satisfactory alternative to smoking because the user is still consuming nicotine, the active agent in tobacco. But when people inhale vapour from an e-cigarette, they are not breathing in the harmful products of combustion in cigarette smoke.

There are 10 million smokers in the UK (approximately 20% of adults) and around 1.3 billion worldwide — the current annual premature death toll attributed to smoking is 100,000 and six million, respectively. The World Health Organization (WHO) estimates one billion premature deaths from smoking in the 21st century on current trends.

The public health proposition is that e-cigarettes can substitute for cigarette use and provide a satisfactory alternative to smoking, with e-cigarette use expected to be at least 20 times safer than smoking tobacco cigarettes^[1].

A survey published by Action on Smoking and Health in July 2014^[2] showed that 2.1 million people in Great Britain are using e-cigarettes and around one third are now ex-smokers. To affect the immediate welfare and long-term health outlook of 700,000 people is an achievement, requiring no NHS resources or public spending. One Wall Street analyst, Bonnie Herzog of Wells Fargo Securities, projects that vaping will surpass smoking within a decade^[3]. Other analysts are less bullish, but many see great potential. If anything close to this scale of change does occur, it will be one of the most remarkable public health phenomena in history.

Risks and concerns

No one could claim that vaping is entirely benign but it does not need to be to make large inroads into the burden of smoking-related disease. Studies of liquids and vapour chemistry reveal traces of contaminants and thermal breakdown products that are potentially harmful, but at low levels unlikely to pose a material threat.

The most comprehensive review of e-cigarettes so far was conducted by Igor Burstyn of Drexel University, Philadelphia^[4].

“The current state of knowledge about chemistry of liquids and aerosols associated with electronic cigarettes indicates there is no evidence that vaping produces inhalable exposures to contaminants of the aerosol that would warrant health concerns by the standards that are used to ensure safety of workplaces,” he concluded. “Exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern.”

We cannot rule out unexpected effects in the future but, for now, we know enough from the basic chemistry involved, toxicology of liquids and vapours, trials of the products and surveys of users to be confident that e-cigarettes can have a positive impact on the health of those who switch from smoking.

Opponents of e-cigarettes now concentrate on ‘population’ arguments. This is the idea that, although vaping is considerably less hazardous than smoking, at population level it could be more dangerous because it changes the way people smoke. For example: e-cigarettes might serve as a ‘gateway’ to smoking for adolescents; they might dissuade people from quitting smoking; and they might ‘renormalise’ smoking in society.

In fact, none of these hypothetical effects have so far materialised. As expected, e-cigarettes are displacing smoking, as one of the UK’s foremost experts in smoking cessation, Robert West of University College London, points out.

“Evidence conflicts with the view that electronic cigarettes are undermining tobacco control or ‘renormalising’ smoking, and they may be contributing to a reduction in smoking prevalence through increased success at quitting smoking,” he says.

Scare stories

Anyone hoping to gain an insight into the safety of e-cigarettes by reading newspapers should tread carefully. There is something of a propaganda war raging and many spurious claims are published uncritically. For example, the fact that particle size of the e-cigarette vapour aerosol is similar to that of tobacco smoke led Metro to write an article on 30 July 2014 with the headline “E-cigarettes ‘may also cause lung cancer’”^[5]. Of course, the chemistry of tobacco smoke does the damage, and that is completely different to e-cigarette vapour.

Professionals looking for guidance on the evolving science should consult literature reviews in the formal academic press. The most recent and authoritative is by Peter Hajek and colleagues, published in the journalAddiction^[6]. The authors conclude: “Health professionals may consider advising smokers unable or unwilling to quit through other routes to switch to [electronic cigarettes] as a safer alternative to smoking and a possible pathway to complete cessation of nicotine use.”

A further source of concern to critics is the role of the tobacco industry in the e-cigarette market. In practice, it is hard to see how this could be negative: the tobacco industry is threatened by e-cigarettes and has entered the market by buying firms to catch up. To survive, each company will need to produce high quality alternatives or risk losing market share to other tobacco companies or non-tobacco e-cigarette companies. Competition will force them to make better products and, as a result, they will become a driver of the wholesale switch from smoking to vaping.

The risk of regulation

The development most likely to put the e-cigarette market at risk is not the tobacco industry but excessive regulation. It might seem like a paradox, but at the heart of the regulatory challenge there is a ‘double negative’: being tough on e-cigarettes is being tough on the competitive alternative to cigarettes — and that may lead to more smoking and more ill-health than it prevents.

In a report on electronic nicotine delivery systems (ENDS) published in August 2014, the World Health Organization (WHO) called for tougher regulation on e-cigarettes. It issued a series of recommendations, including a ban on indoor use until there is evidence that exhaled vapour is not harmful, stopping sales to children and putting health warnings about nicotine on products. It also recommended that manufacturers, and others, should be prevented from describing the products as smoking cessation aids, until there is scientific proof of their effectiveness.

However, the science base behind the WHO report was strongly criticised within a week of publication by UK and European experts^[7] and the Department of Health was quick to reject WHO’s proposal for a legal ban on vaping in public places^[8]. Policy analysts warn that excessive tough regulation of e-cigarettes give cigarettes and smoking an easy ride and effectively protects cigarette sales and causes more disease and death. The battle over the right balance of regulation and commercial freedom is sure to rage on.

At the moment, e-cigarettes are regulated as general consumer products but since 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) has encouraged companies to submit medicine licence applications voluntarily for e-cigarettes to be approved as medicines.

The European Union has produced e-cigarette regulation in the revised Tobacco Products Directive that will come into effect from May 2016 for e-cigarettes containing up to 20mg/ml of nicotine. It includes a ban on advertising that will protect cigarettes from competition; limits on liquid container sizes; and bold warnings covering 30% of the pack. The measures were negotiated behind closed doors with no credible scientific or legal basis. E-cigarettes with stronger concentrations of nicotine, used by more dependent smokers, will require authorisation by MHRA as over-the-counter medicines in the UK.

The system of medicine regulation is not well suited to regulating recreational products because the products are not medicines, either in law or common sense. It applies heavy costs, burdens, restrictions and unnecessary technical demands that would limit the range of products and number of suppliers, while acting as a barrier to innovation. It is likely that only tobacco companies entering the business would be able to comply.

What should happen next?

The future plans for tougher regulation could damage the market for e-cigarettes. A rethink is needed — either through a policy change or the European Court of Justice. There is little wrong and much that is positive with the market as it functions today. It would benefit from some genuine light touch regulation that builds consumer confidence but the proposals in place could destroy perfectly good firms and greatly limit the diversity of products.

Some changes would be useful, such as purity and safety standards for liquids, some design constraints for vaping devices, tamper-proof liquid containers, proportionate health messages that encourage smokers to switch and restrictions on marketing similar to those in place for alcohol. Regulation in moderation could assist, but this is a market-based revolution that should be led by consumers, innovative producers and engaged retailers. If regulators intervene too strongly, they will end up doing far more harm than good.

Clive Bates worked with 53 specialists in nicotine science and public health to co-ordinate and deliver a letter to Dr Margaret Chan, the Director General of the World Health Organization, arguing against excessive regulation of e-cigarettes and urging caution in the handling of safer alternatives to smoking when WHO hosts the sixth conference of the parties to its Framework Convention on Tobacco Control, due to be held in Moscow on 13 October to 18 October 2014.

References: 

^[1]West R, Hajek P, Mcneill A, et al. Electronic cigarettes: what we know so far. A report to UK All Party Parliamentary Groups. Smoking in England, 2014.

^[2]Use of electronic cigarettes in Great Britain. Action on Smoking and Health. July 2014.

^[3]The Economist. Kodak moment. 28 September 2013.http://www.economist.com/news/business/21586867-regulators-wrestle-e-smokes-tobacco-industry-changing-fast-kodak-moment (accessed 10 September 2014)

^[4]Burstyn I. Peering through the mist: what does the chemistry of contaminants in electronic cigarettes tell us about health risks? Department of Environmental and Occupational Health School of Public Health, Drexel University, Philadelphia. Published July-August 2014.

^[5]Metro. E-cigarettes and vaping ‘may cause lung cancer like normal cigarettes’. 29 July 2014.http://metro.co.uk/2014/07/29/e-cigarettes-and-vaping-may-cause-lung-cancer-like-normal-cigarettes-4813648/ (accessed 10 September 2014)

^[6]Hajek P, Etter J, Benowitz N, et al. Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit. Addiction 2014. doi:10.1111/add.12659 (accessed 10 September 2014)

^[7]McNeill A, Etter J-F, Farsalinos K, et al. A critique of a WHO-commissioned report and associated article on electronic cigarettes. Addiction 2014. doi:10.1111/add.12730 (accessed 10 September 2014)

^[8]The Guardian. E-cigarettes: no indoor smoking ban planned in England despite WHO call. 26 August 2014. http://www.theguardian.com/society/2014/aug/26/e-cigarettes-no-indoor-smoking-ban-england (accessed 10 September 2014)

Citation: The Pharmaceutical Journal, September 2014, online | URI: 20066415

Breaking News: New study shows no risk from e-cigarette contaminants... by Carl V Phillips

[UPDATE  3: The published version of the paper, at BMC Public Health, is nowhere.]

[UPDATE:  Here is CASAA's press release about this.]
[UPDATE 2: Here is the post of the press release at CASAA's main blog (same content as above link, but with a link to here for discussion -- so a better choice if you want to share the press release).]

CASAA is delighted to announce that the first research study funded by the CASAA Research Fund (thanks to all of you who donated to that!) has been released.  The study, by Prof. Igor Burstyn, Drexel University School of Public Health, is available at the Drexel website, here (pdf).  Burstyn reviewed all of the available chemistry on e-cigarette vapor and liquid and found that the levels reported — even in those studies that were hyped as showing there is a danger — are well below the level that is of concern.

And that assessment applies to the vaper himself.  The exposure to bystanders is orders of magnitude less and of no concern at all.

The paper is technical, of course, but I believe it does a great job of communicating for readers at many levels.  It puts the results in very clear and useful terms — exactly what policy makers need for making decisions.

For the first time, we have a definitive study that can be used to respond to claims that contaminants in e-cigarettes are dangerous and that there is a hazard to bystanders that calls for usage restrictions.  Existing individual chemistry studies have been difficult for anyone other than an expert to understand (which is why we gave a grant to an expert to understand them!), and a naive interpretation of individual studies (just reading what the authors editorialized about their results) gave the impression of “dueling studies”, with some showing a problem and some not.  While many THR advocates made an effort to make sense of and use the existing literature, it was almost impossible to do so effectively.  Burstyn’s analysis solves that problem and shows there is no duel:  All of the studies, including the “bad” ones, show that there is no worry.

I cannot overstate it:  This is a game-changer for anyone trying to respond to misinformation about the hazards of e-cigarettes.  Before we had an apparently contradictory mess on this topic.  Now we have clarity.

I have to say that I am genuinely surprised that the results are quite so definitive, and I assume that will be true of anyone else of was seriously trying to assess the risks, rather than just cheerleading.  We were all confident that the risks were minimal, but we could not previously reach a (good news) conclusion as strong as the one in the paper.

The list of key conclusions in the paper:

• Even when compared to workplace standards for involuntary exposures, and using several conservative (erring on the side of caution) assumptions, the exposures from using e-cigarettes fall well below the threshold for concern for compounds with known toxicity. That is, even ignoring the benefits of e-cigarette use and the fact that the exposure is actively chosen, and even comparing to the levels that are considered unacceptable to people who are not benefiting from the exposure and do not want it, the exposures would not generate concern or call for remedial action.
• Expressed concerns about nicotine only apply to vapers who do not wish to consume it; a voluntary (indeed, intentional) exposure is very different from a contaminant.
• There is no serious concern about the contaminants such as volatile organic compounds (formaldehyde, acrolein, etc.) in the liquid or produced by heating.  While these contaminants are present, they have been detected at problematic levels only in a few studies that apparently were based on unrealistic levels of heating.
• The frequently stated concern about contamination of the liquid by a nontrivial quantity of ethylene glycol or diethylene glycol remains based on a single sample of an early technology product (and even this did not rise to the level of health concern) and has not been replicated.
• Tobacco-specific nitrosamines (TSNA) are present in trace quantities and pose no more (likely much less) threat to health than TSNAs from modern smokeless tobacco products, which cause no measurable risk for cancer.
• Contamination by metals is shown to be at similarly trivial levels that pose no health risk, and the alarmist claims about such contamination are based on unrealistic assumptions about the molecular form of these elements.
• The existing literature tends to overestimate the exposures and exaggerate their implications.  This is partially due to rhetoric, but also results from technical features.  The most important is confusion of the concentration in aerosol, which on its own tells us little about risk to heath, with the relevant and much smaller total exposure to compounds in the aerosol averaged across all air inhaled in the course of a day.  There is also clear bias in previous reports in favor of isolated instances of highest level of chemical detected across multiple studies, such that average exposure that can be calculated are higher than true value because they are “missing” all true zeros.
• Routine monitoring of liquid chemistry is easier and cheaper than assessment of aerosols.  Combined with an understanding of how the chemistry of the liquid affects the chemistry of the aerosol and insights into behavior of vapers, this can serve as a useful tool to ensure the safety of e-cigarettes.
• The only unintentional exposures (i.e., not the nicotine) that seem to rise to the level that they are worth further research are the carrier chemicals themselves, propylene glycol and glycerin.  This exposure is not known to cause health problems, but the magnitude of the exposure is novel and thus is at the levels for concern based on the lack of reassuring data.

It is worth expanding on the observation about propylene glycol and glycerin a bit:  While there is no affirmative reason to believe that the level of exposure experienced by vapers is hazardous, we have never before had a situation where millions of people had such a high level of exposure.  Thus it is worth gathering data on what happens, just to make sure there is no small subtle effect.  This contrasts with the levels of the much-hyped contaminants, which pose no concern at all.  It is also important to remember that this refers to the vaper herself; there is no such caution for bystanders, who have far far lower levels of exposure.

This paper should immediately become a central point in all political advocacy to stop anti-e-cigarette regulations, as well as trying to encourage smokers to adopt THR.  The key talking point that should be used is this (my words, not Burstyn’s):

The only expert review of all of the studies found that there was no risk from the chemicals to vapers, let alone bystanders.  This took into consideration the studies that you are referring to [note: assuming this is being used as a rebuttal to some claim of chemical hazards].  Indeed, even the results of the studies that have been used to generate alarm represented levels of chemicals that were too low to be of concern.

For those of you who have any comments for the author, particularly peer review (or even non-peer review) comments for improving on the working paper before it is submitted to a journal[*], please use the comments section of this post.  The author has agreed to monitor one page (this one), but will probably not see it if you post a comment at another blog, on ECF, etc.

[*Footnote: To head off a concern I have heard a few times, no, there is not a problem with the author releasing a working paper before submitting to a journal.  A handful of medical and general-science journals -- those that are trying to sell copies as if they were a glossy magazine -- like to have "exclusives" of previously secret studies (which, by the way, is why they publish far more papers that are shown to be wrong than do more serious journals).  Serious science journals generally prefer that the paper is circulated and commented on before they are asked to deal with it.  Indeed, in several of the more serious sciences (public health will catch up in a few decades -- perhaps), working paper versions are considered the key source of scientific communication, and the eventual appearance in a journal is more of an afterthought and happens long after everyone has already read the paper.  Real peer review is what starts now (here) when every interested expert can read and comment, rather than at a journal where a couple of people with their limited knowledge are the only ones reviewing it.

[Of course, that knowledge does not help you if you are dealing with people who do not understand how science works and are not likely to listen long enough to learn.  There will be retorts of "that is not a peer-reviewed publication" (which is actually not true -- it was reviewed before the author released it).  Your best talking point in response to that is something like, "So are you saying that in a few months, when the paper appears in a journal, you will agree that it is all correct and change your position?"  If you are responding to someone who claims to be an expert, you can add "So, why don't you just review it like other expert readers have done, or are you admitting that you are not expert enough to do so?"

[UPDATE 3 vers.2: Later posts here that relate to this study can be found at this tag.]

by Carl V Phillips

As Seen on Anti-THR Lies

Know Your E-Cig Ingredients: Propylene Glycol

A common knock against e-cigarettes is that we don’t know the long-term health effects of consuming nicotine vapor.  The fact is that while it’s impossible to have complete knowledge about a novel form of tobacco use, scientists already know a great deal about propylene glycol (PG), a key ingredient of the vapor in e-cigarettes.

A comprehensive 2012 PG toxicology review, authored by members of the Cosmetics Ingredient Review (CIR) expert panel, appeared in the International Journal of Toxicology (available here). 

The report was an update of a 1994 assessment which concluded that PG was “safe for use in cosmetic products at concentrations up to 50.0%” – the cosmetic industry standard at the time.    By 2012, PG was used in 9,094 of 34,391 cosmetic and personal care formulations.  One of the most interesting passages in the 1994 document was a description of aerosolized PG in hair sprays:

“Propylene glycol is used in hair sprays, and its effects on the lungs that may be induced by aerosolized products containing this ingredient may be of concern.  The aerosol properties that determine deposition in the respiratory system are particle size and density.  The parameter most closely associated with deposition is the aerodynamic diameter, d_a, defined as the diameter of a sphere of unit density possessing the same terminal settling velocity as the particle in question.  In humans, particles with an aerodynamic diameter of < 10 um [micrometers] are respirable.  Particles with a d_a from 0.1 to 10 um settle in the upper respiratory tract and particles with a d_a < 0.1 um settle in the lower respiratory tract.  Particle diameters of 60 to 80 um and > 80 um have been reported for anhydrous hair sprays and pump hairsprays, respectively.  In practice, aerosols

should have at least 99% of their particle diameters in the 10 to 110 um range and the mean particle diameter in a typical aerosol spray has been reported as ~ 38 um.  Therefore, most

aerosol particles are deposited in the nasopharyngeal region and are not respirable.”

In contrast, PG aerosols generated by e-cigarettes appear to be smaller, in the range of 0.1 to 0.4 um, according to a study published last year (abstract here).  So, while it likely that most e-cigarette vapor is settling in the upper respiratory tract, some small aerosol particles are likely reaching deeper lung tissue. 

The 2012 CIR panel also commented about PG as a food additive: “According to the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the acceptable daily intake of PG is 25 milligrams per kilogram of body weight per day.  In Japan, the Ministry of Health, Labour, and Welfare (MHLW) specified that according to the food sanitation law, PG has no potential to cause harm to human health.”

The CIR panel also reviewed numerous animal studies regarding potential problems.  They concluded: “Both PG and PPGs [polypropylene glycols] were not considered to be acute or

chronic toxicants in oral or dermal studies, were not genotoxic or carcinogenic, and were not reproductive or developmental toxicants, supporting that their use in cosmetics would be safe

in regard to these end points.”   

The CIR was established in 1976 by an industry association with the support of the FDA and the Consumer Federation of America; it reviews and assesses the safety of ingredients used in cosmetics.  University faculty, industry representatives and the director of the Office of Cosmetics and Colors at the FDA participate in the reviews, which are conducted according to published procedures (here).  The CIR appears to be an excellent example of cooperation between federal regulators and the industry they regulate; it might serve as a template for cooperation among the FDA Center for Tobacco Products and tobacco manufacturers. 

The FDA has thus far taken an aggressively antagonistic approach in its regulatory procedures, some of which are dictated by the 2009 enabling legislation.  For example, the legislation prohibits members of the FDA Tobacco Product Scientific Advisory Committee (TPSAC) from having any relationship with the tobacco industry in the 18 months preceding their appointment (documented here).  This is in direct contrast to all other federal advisory committees (including expert CIR panels), in which an industry conflict of interest for a qualified candidate is reportable but not prohibited.

The CIR served the public interest in producing an informative PG safety review; it also serves as a role model for constructive government-industry interaction.

Posted by Brad Rodu

E-Cig Myth #1...

Myth #1: Electronic cigarettes are just like tobacco cigarettes

While the two look similar, their differences are tremendous. Aside from providing an alternative experience to smoking, electronic cigarettes are nothing like tobacco cigarettes.

Most significantly, electronic cigarettes do not produce smoke. In contrast, tobacco cigarettes produce smoke from burning tobacco, which contains over 5,000 chemicals, many known to cause cancer.

Public health experts all agree that tobacco cigarettes are deadly. Conversely, several well-respected public health experts are involved in the electronic cigarette industry. Among these is a former US Surgeon General, currently serving on a leading electronic cigarette company’s Board of Directors and the past president of the American Lung Association, who recently joined an electronic cigarette advocacy group. And prominent professors, such as Boston University’s Michael Siegel, advocate for electronic cigarettes as an alternative to tobacco cigarettes.

Aside from providing an alternative experience to smoking, electronic cigarettes are nothing like tobacco cigarettes.

http://www.vaportruth.com

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Seattle Hempfest 2013

Mission

Seattle Hempfest is founded in the belief that the public is better served when citizens and public officials work cooperatively in order to successfully accomplish common goals.

Objective and Purpose

To educate the public on the myriad of potential benefits offered by the Cannabis plant, including the medicinal, industrial, agricultural, economic, environmental, and other benefits and applications. In particular, Seattle Hempfest seeks to advance the cause of Cannabis policy reform through education, while advancing the public image of the Cannabis advocate or enthusiast through example.

Company Overview

Seattle Hempfest is the world’s largest event advocating cannabis law reform, in a unique “protestival” environment. This annual event is held every August in Myrtle Edwards Park on the Seattle waterfront.

Seattle Hempfest 2012 - Video produced by THCTV

We will be attending Seattle Hempfest 2013!!!

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