Tag Archives: vapor chemistry

Attacking ecigs to encourage continued smoking: predatory lawsuit and goofy California law edition

by Carl V Phillips

I have finally realized that there is an answer to “what benefit results from FDA jurisdiction over tobacco products?” FDA regulation (and I use that term very loosely) has harmed consumers and commerce by gumming up free markets, damaged public health by interfering with THR, and threatens to do far more of each in the future, all for no apparent benefit. When asked to explain what they have accomplished, even FDA CTP or their umbrella agencies have no answer. They invariably lead with the banning of flavored cigarettes when trying to brag about their accomplishments, even though this happened basically on day one, was specifically mandated by Congress, and did not do anything other than deprive the few thousand adult smokers who actually used those products of a bit of life’s pleasure. I would have to call that self-damning with faint praise.

But there is an answer to the question: Without federal preemption, California would have a free hand to regulate these products.

I am obviously not saying this justifies the enormous social harm that has been and will be caused by FDA “regulation” of tobacco products. After all, most of us think of Californians much as we do Saudi Arabians or Australians — we might feel a bit sympathy about their welfare-reducing governments, but their lives are still better than most humans’, so it is hard to feel too bad. But still it is the answer to the “name even a single benefit” question.

California has a law known as Proposition 65 whose anti-science is just one step better than executing people for witchcraft. It requires that every building that the public is allowed in post a warning that there are chemicals present that are known to cause cancer and reproductive harm. Ok, strictly speaking it requires that only if those chemicals are present, but since they always are present everywhere, that is a distinction without a difference. This is not a warning about actual risk — an inconsequential quantity of one chemical that breaks the ridiculously low threshold requires the same warning as the air being thick with toxins — so this obviously serves no useful purpose. There is a similar requirement for many consumer products. Selfish lawyers can make a nice living shaking down businesses that violate the utterly useless provisions of Prop 65.

Ironically, cigarettes do not have to have the California warning about carcinogens or harm to fetuses, thanks to federal preemption. At the moment, though, e-cigarettes do not benefit (and, again, I refer to a single benefit, not overall net benefit) from that preemption. Thus, some lawyers — in this case operating under the guise of being a public interest charity — are using Prop 65 to shake down e-cigarette manufacturers. The group fancies itself “The nonprofit health watchdog Center for Environmental Health” (CEH), even though most of its income from the last year reported came from awards from lawsuits and “fees” (which I am guessing are shakedown payments, since it is not clear who they could be legitimately charging for their “services”) and it was described as the “most predatory litigant” in the Prop 65 space. They describe themselves thusly:

The Center for Environmental Health (CEH) is the leading national nonprofit committed to ending health threats from toxic chemicals in our air, water, food and in products we use every day. CEH protects children and families from harmful chemicals by working with communities, consumers, workers, and government to demand and support safer business practices. We also work with major industries and leaders in green business to promote healthier alternatives to toxic products and practices.

It would be funny if they were not so harmful. You would think that the “leading national nonprofit” would be a household name. Had you ever heard of them before this week? I didn’t think so. You probably have heard of the NRDC — there is a lot bad to say about them too, but at least when they use the word “leading” you do not giggle. I also like the “children and families” bit — if you are single, then you can just go suck benzene. But of course, the real problem is the claim that forcing business to put an utterly pointless “warning” everywhere — a statement which ACSH cleverly describes as “ignored by the populace, except for Prop. 65 lawyers” — does anything whatsoever to help anyone other than the lawyers.

It was CEH that attacked e-cigarette manufacturers over Prop 65 warnings earlier this year. At least that produced some humor. But their true harmful nature came out this week when they not only filed a notice that makes demands of and threatens legal action against numerous of e-cigarette companies which would provide no conceivable health benefits, but released a “report” (which is really a marketing-style brochure) that made junk science claims that would tend to scare smokers away from switching to e-cigarettes. In particular, their headline claim in their press release was “High Levels of Cancer-Causing Chemicals in the Majority of Nearly 100 E-cigarettes Tested”. How high? They offer absolutely no context for that word in the press release and nothing clear in the “report”.

We know that the real answer is “not high enough to worry about”. The two chemicals they are talking about are formaldehyde and acetaldehyde, which have been measured in pretty much every study of e-cigarette emissions and found not to be present at levels that pose a concern. The thing is, the Prop 65 exposure limits for these are such that everyone will exceed them. You exceed the formaldehyde threshold merely by breathing (and recall that dead people were not included in that list with children and families). So their vague reporting of how many multiples of these meaningless numbers they found are not informative about their results, and offers no support for their attempts to scare consumers.

Your first question about how they got their results might be what lab methodology did they use to produce those quantities? They do not say, other than saying it was done using smoking machines, which very likely resulted in the overheating that produces far more pyrolysis products than actual vaping does. They insist that they did not overheat the devices, but offer no substantive support for this dubious assertion. But those observations are not anywhere near the top of their failures to report their methods. That list starts with them not even reporting what quantity of consumption generates the supposed results. As far as we know, they estimated the total exposure that would result from taking every waking breath as a puff on an e-cigarette. The failures continue from there. Gregory Conley sought more information about their methodology, but reports that they refused to provide it. Not exactly surprising.

Of course, those problems are only failures if one models their behavior as attempting to help people or to do science, rather than to shake down manufacturers for a few million dollars, and perhaps get a piece of the tobacco control industry gravy train. Since most of their “report” has nothing to do with their actual Prop 65 complaint, but is just a simplistic shoveling of every anti-ecig myth and complaint that tobacco controllers recite, it seems like the latter is part of the goal.

I am not sure whether CEH ever did anything that actually improved anyone’s health. But if they did, any such benefit could easily be swamped by what they are doing now. If the public even notices this money-grab, and if they believe the claims (or others cause them to), it will probably cause a lot of would-be vapers to smoke instead.

Already a few ANTZ are gleefully reporting on this travesty as if it has information value about e-cigarettes causing harm. We can come back to that question I started with, “is there any benefit whatsoever?” In this case, there is information value: Anyone who touts this anti-scientific attack as if it were informative is making clear their utter scientific illiteracy and lack of ethics. Not just the tobacco control standard level of illiteracy, lack of ethics, and generally cluelessness, but something deeper still. They are repeating meaningless rhetoric that is based on completely unreviewed assertions whose actual meaning cannot even be determined because of missing information. This does not even rise to the level of being junk science — it is non-science, as should be obvious to anyone who reads even the press release.  Moreover, that claim comes from an organization with no scientific credibility, and for whom the term “conflict of interest” does not even apply because their only apparent interest is bolstering their legal claims.

So which particular bottom feeders sunk to this new depth? That would be the World Health Organization (FCTC), as well as a few of the worst pseudoscientists (GlantzChapman, Malone) and others among the least credible anti-THR activists (World Lung Foundation, Leno (this guy)). But most of the other usual suspects have been sensibly silent about this travesty, refusing to stoop to quite this level. We can thus now have a new measure — the CEH Test — for differentiating standard tobacco control levels of evil and/or stupidity from the worst of them. Let’s see if anyone else sinks below this line by citing the CEH claim.

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Post publication peer-review: Correction to Burstyn (2014) and related matters

by Carl V Phillips and Igor Burstyn

[Igor Burstyn is an Associate Professor at Drexel University School of Public Health and a member of the CASAA Board of Directors. His research that is described here was sponsored by CASAA.]

Burstyn (2014), “Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks”, BMC Public Health, is probably the most read scientific paper on e-cigarettes and among the most read in the history of tobacco harm reduction. It is often described as the most important paper on e-cigarettes, being the first to point out that there is ample existing evidence that the non-novel chemical exposures from vaping – which are used to concoct alarmist propaganda — are inconsequential. So imagine our surprise when, after well over 100,000 people had viewed the paper at the journal’s website and countless more via other means (the announcement of the publication of the working paper version remains the most read post on this blog), it went through journal peer-review, and each of us poured over many revisions, one astute reader caught a bright-line error in the results. It is recounted in the following text by IB: Continue reading

California ecig “regulation” hearing: a catalog of lies (part 1)

by Carl V Phillips

On April 8, the California Senate Health Committee held a hearing on an anti-ecig bill. This was an amazing job of cataloging the many anti-THR lies about e-cigarettes. The main immediate impact of the bill would be to ban vaping in all the private and public (mostly private) places where smoking is banned, but the preamble of the bill makes clear that the plans are much worse than that, including licensing and laying the groundwork for punitive taxes on vapers. (That would be to punish them for denying California the buck-and-a-half per pack (approximately) that they were paying the state when they smoked.) Continue reading

FDA thinks antifreeze is ok — for kids’ medicine (and other accidentally useful observations in the NYTimes)

by Carl V Phillips

The New York Times is a reliable mouthpiece for various powerful political factions but, frustratingly, is also a great source of information. As a result, we are forced to read it much the way that Soviet citizens learned to read Pravda — the information is there, but you have to learn how to read between the lines. A clever reader (h/t Gil Ross) spotted the NYT pointing out that FDA was blatantly hypocritical when they hyped the claim that “e-cigarettes contained antifreeze” during their attempt to ban them in 2009 (and — even worse — keep reporting that lie).

Background: In 2009, in an attempt to smear the e-cigarette companies that were suing them for illegally seizing products, FDA conducted studies of some of their liquids. They discovered a trivial contamination with diethylene glycol (DEG), in one unit, at a level that Burstyn has pointed out posed no concern. They tried to fool the public into believing this was a substantial hazard. Continue reading

Breaking News: New study shows no risk from e-cigarette contaminants

by Carl V Phillips

[UPDATE 4, 11 Jun 15: A correction to one of the results in the study has been posted to this blog by the author. As of yet, the journal has not posted the correction as requested.]

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

[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.]

Real public health research on e-cigarettes?

by Carl V Phillips

A funny thing appeared in the abstracts for the upcoming meeting of the Society for Research on Nicotine and Tobacco (SRNT).  Buried amidst the few dozen abstracts about e-cigarettes from the “public health” people is some actual public health research (i.e., research that could inform messages and regulation that would help people be healthier).

Most of the abstracts on e-cigarettes are just dumb make-work projects, presumably by people trying to justify their employment.  There are numerous surveys of attitudes, which mostly just reflect how the questions were asked and are changing by the month, and other variations on how to provide no useful information other than perhaps a historical record about the social dynamics of THR adoption (I will probably try to mine them for that).

Not surprisingly, many of the supposed social science projects violate the ethical norms of social science by using the concocted term “ENDS” rather than using the population’s preferred terminology for e-cigarettes.  This offers absolutely no scientific benefit (e.g., it does not more precisely define the behavior) and was clearly designed to be somewhat derogatory, but most of all it is designed to assert researcher primacy over a population’s own self-identity.  Some types of scientists can make up words when they are helpful, and political actors can have some fun with it when describing the powerful (e.g., “ANTZ”); people doing sociological research are ethically obliged to respect the populations they are studying.  Imagine researchers making up a patronizing name to refer to a self-identifying ethnic/cultural group; their writing would generate serious deserved backlash and be refused by any respectable journal or research organization.  This alone says a lot about these “researchers” and SRNT.

Most of the abstracts contain disinformation and, indeed, the one that I am highlighting has disinformation built into it (see below) despite its possible value.  It is by Alan L. Shihadeh and Thomas Eissenberg, who unlike their SRNT colleagues seem to be trying to do useful work and have some inkling of what useful science looks like.

(However, in spite of his increasingly valuable contributions, I believe the latter still owes the world an apology and/or retraction for his widely-cited publication that claimed that e-cigarettes do not deliver nicotine.  Politicians and activists make errors like that all the time and then pretend it never happened; scientists who make the mistake of epistemic immodesty need to rise to a higher ethical standard.  In science, the phrase “our one-off limited empirical study found something contrary to what all the previous evidence suggests” should always be followed by “so we probably did something wrong, so please ignore this result until we do additional research” rather than by “and therefore what everyone knew before was wrong” (or, better still, they should do the additional research to explain the discrepancy before publishing).  He does however get credit for trapping the ANTZ into starkly illustrating that science is just window-dressing to them and they do not really care what it shows:  When they were foolish enough to believe his claim, they condemned e-cigarettes as failures because they do not provide nicotine.  After it became clear that his claim was wrong, they condemned e-cigarettes because they effectively deliver evil evil nicotine.)

The abstract (or just skip down to my observations about it if you are in a hurry – there is really just one important point in it):

Background: “Electronic cigarettes” (ECIGs) heat a nicotine-containing solution to produce a vapor for inhalation. There is considerable variability in device characteristics and puff topography and each of these factors may be related to vapor toxicant content.

Method: We investigated the role of device voltage and puff duration on vapor toxicant content. We examined total particulate matter, nicotine, and volatile aldehyde emissions from 15 consecutive puffs of V4L™ ECIG cartridges (18 mg/ml nicotine) while varying device voltage (3.7 vs 5.2 volts) and machine-produced puff duration (1.8 vs 3.6 s). We used a puff velocity of 38.8 ml/s and 10 s interpuff interval (Goniewicz et al., 2012). In another study, we investigated a non-cartridge ECIG use method that involves dripping nicotine containing liquid directly onto a heating element and inhaling the resulting vapors. We measured aldehyde emissions from dripping 3 drops of e-liquid (16 microL, similar to the amount of e-liquid consumed in 15 e-cig puffs) onto a 300 C heater surface.

Results: The higher voltage tripled vapor nicotine content, and doubling puff duration doubled nicotine content. We also found that longer puffs resulted in greater cartridge temperatures, and that, for a given puff duration, higher puff velocities resulted in lower temperatures. Dripping liquid onto a heater surface produced more than 200 micrograms of formaldehyde, compared to 0.03 micrograms for 15 puffs of an ECIG cartridge (V4L™cartridge, topography of Goniewicz et al., 2012). We also measured 2-20 fold greater emissions of other aldehydes (9 species in total).

Conclusions: Overall, these results demonstrate that device characteristics (e.g., voltage), puff topography, and use behavior (i.e.,“dripping”) can influence vapor toxicant content. Indeed, these findings suggest that ECIG aficionados who take longer duration, slower puffs (Hua et al., 2011) are working to obtain higher nicotine doses and that those who drip liquid directlyon the heater (McQueen et al., 2011) risk significant exposure to formaldehyde that is a human carcinogen and is associated with COPD in conventional tobacco product users.

Most of the results fall into the “incredibly obvious” category:  Faster puffs result in lower temperatures (because more cool liquid moves across the atomizer, cooling it faster than it can heat).  Longer puffs extracted more nicotine, approximately proportional to the length of the puff (anyone surprised by that?).

It was interesting to see how much delivery (reported as nicotine quantities, but that is obviously just a measure of how much total liquid was aerosolized) increased with the increase in voltage.  This, of course, is not some universal finding for the ages, like something that might be discovered about the behavior of a molecule (though undoubtedly countless naive readers will interpret it as such).  Every result in this research depends heavily on the exact variables of the equipment and other methods they were using, and every device and every user is different.  But the authors get credit for actually varying a few of the variables a bit.  Reading most of the research on e-cigarettes would give the impression that there are no such variables, so actually the authors get a lot of credit for starting to correct that error.

The result that is potentially real health-affecting knowledge (unlike, as far as I can tell, every other bit of research on e-cigarettes in the SRNT abstracts) is the result of dripping e-cigarette liquid onto a heater at 300C.  This result is, unfortunately, also the germ of more disinformation because this is far hotter than what actually occurs (except, perhaps, with a seriously ill-advised novelty mod).  This presumably explains why the concentration of formaldehyde they found is enormously higher than that observed in analyses of real e-cigarette vapor.  Even if you preheat an atomizer to that temperature before dripping on it, it will rapidly cool toward an equilibrium temperature.  I am guessing that the “heater surface” they used was a piece of lab equipment that has a much larger mass than an atomizer filament, and thus maintained close to the original temperature rather than rapidly cooling when the first bit of liquid touched it.

We can safely assume that some people will spin this result as showing that e-cigarettes generate this quantity of formaldehyde, and thus the way the information was presented is a gift to the liars.  (Perhaps such an offering to the liars is the price of admission to SRNT.)  Still, this might offer a genuine contribution to health.  It does suggest that using very-high-temperature mods or a high preheating of the atomizer (by holding the switch on for too long before starting to draw) might increases vapors’ health risks.  Even if most of the liquid would not be heated to 300C, a bit of it might.  That is intuitive if you think about it:  higher peak temperature = more pyrolysis = more nasty chemicals.  But it is not clear there has been much thinking about it.

There should be more.  Good scientists who have more knowledge than I about the chemistry should really think this through — a little bit of theory and existing general knowledge would be worth for more than a series of one-off experiments on particular equipment.  If there is going to be any actual health-improving research about e-cigarettes, it obviously will not be the attempts to demonize them out of existence, but it also cannot be the attempts to claim everything about them is always just fine.  Real public health researchers do not behave like “public health” people who just look for an excuse to say “never do this, no matter how much you want to”; they figure out how to advise “if you are going to do this, you are better off doing it this way….”  This is, of course, the reasoning behind THR in the first place, and also describes what real health research about nicotine inhaler technologies should look like.  I suspect that most of this public health learning will have to wait until the tobacco companies report what they are doing, but it is good that at least one independent research team is headed in that direction.