Notes from the FDA e-cigarette workshop

by Carl V Phillips

I have several posts worth of material to cover on the themes presented here. I’ll see if I can get to them. In the meantime, some random thoughts about the third FDA Center for Tobacco Products workshop on e-cigarettes that took place on Monday and Tuesday of this week. As with the previous workshops, it was a mixed bag of good science from industry and a few others, sneaking in amidst the utter junk from the “public health” types. At this one, the mix was perhaps almost up to 50-50, which is a lot better than the previous ones. 

The agenda is here. I am not going to attempt to summarize the content or even systematically address the high points in the blog, but rather just highlight a few important points. You can read through my live blog at the CASAA members Facebook page if you want a summary of the whole thing (day 1, day 2). It should be readable; I tried to write the play-by-play bits so that they are readable as an extremely abbreviated summary for non-live readers, though I cannot say I am sure that was successful. The conversational among participants who were watching the presentation may or may not make sense, though I tried to go back and delete the comments that were wholly dependent on references to what had just been viewed for ease of future reading.

So finally, after CASAA submitted multiple applications for presentations at each of the workshops — for me and Igor Burstyn for both, and one other also — we finally managed to get a moment on the podium on behalf of consumers. They still refused to allow us to present our research, rejecting it in favor of the utter garbage that was presented, but at least I got to speak on the final panel of the session. You can view the panel I was in via this link (you have to register and that will give you access to the replay) starting at 2:14. I would not normally recommend people take the time to watch video, but if you like what I write I think you will like what I said. Also, those of you trying to watch it live missed half of it (the live feed of the meeting failed halfway through my panel, which several CASAA members attributed to them wanting to hide what I was saying, though incompetence is always a more likely explanation).  Being a panel it it includes others, of course,  and much of it was about the talks they gave in the session that came before, but it probably will mostly make sense if you just read the titles of their talks in the agenda.

If you do not watch it, you can at least read what I read for my mandatory conflict of interest statement. Never pass up a chance to use a conflict of interest statement to make a statement.

I am Carl V Phillips. My research has focused on tobacco harm reduction for 15 years, first as a professor and now with CASAA. I am here under the auspices of CASAA, which represents its 60,000 members and other consumers and would-be consumers of low-risk tobacco products; this is not a conflict of interest because consumers are the one group whose interest is to understand — without spin or hype — the real health effects of the products.

I should note that this marks the first time at any public meeting in the history of the Center for Tobacco Products that a representative of the primary stakeholder, the consumers, has been given a seat at the table. This appears to be a small step in the right direction, though since I am here in my role as scientific expert rather than consumer advocate, it is not clear whether this really should count.

In terms of my own funding outside of CASAA, at one time or another I have received research grants or consulting contracts from most every sector with a financial interest in this matter. This includes companies that sell e-cigarettes. It also includes those that benefit from sales of competing products: pharmaceuticals, smokeless tobacco, and cigarettes. In particular, I have received funding from those who profit the most from the sales of cigarettes — that, or course, being the governments of the United States and other jurisdictions — as well as those who manufacture those products.

Probably the most interesting thing that came out of the meeting was the various studies that showed that the “second-hand” exposure is even more trivial than we already knew. It appears that about 98% of nicotine is absorbed by the vaper (for normal vaping behavior — cloud chasing is a different story), and it does not much matter whether you hold the vapor in. It turns out that holding your breath for a few seconds matters if you want to avoid creating any visible exhalate, but really does not change the nicotine delivery. Indeed, even when a vaper allows some visible exhalate, most of the PG and glycerol, and presumably most of the trivial quantities of other chemicals, are also absorbed. This means that the bystander exposure is going to be many orders of magnitude less than the vaper’s exposure (which causes no known health effects). The quantities in the entire room someone is vaping in are almost two orders of magnitude less than what the vaper absorbs. Since someone else in that room is going to breathe only a tiny fraction of that air, actual exposure is orders of magnitude less than that. So rather than the three orders of magnitude less exposure than the vaper that Burstyn estimated, we should probably be thinking in terms of a worst case scenario of four orders (i.e., less than 1/10,000th the exposure).

To appreciate my joke from the panel discussion, if you choose to watch that, you need to know that the exception to those results was one complete wackadoodle presenter, a freelance environmental testing guy from San Francisco, who was presenting a bunch of nonsense conclusions about something he did (yes, “something” — he never explained his methodology) and claiming there was some dire risk to bystanders. He also practically filibustered the panel discussion from his session, even though it contained several real scientists with useful contributions to make, and yet he still never managed to explain what he was claiming. I assume FDA included him in order to make sure their pet “researchers” — the highly practiced liars — looked credible by comparison.

18 responses to “Notes from the FDA e-cigarette workshop

  1. Chuck Palmer

    Glad to see that “studies” are making a distinction between “normal” vaping and extreme vaping (aka cloud-chasing). Now the question is, what is “normal” vaping and who is going to define it. I personally define “normal vaping” it as vaping under 20 watts and under 6 volts. However, I would agree with anyone who would want to define it at anything under 15 watts and under 5 volts.

    Something the medical community needs to look into, btw, is the link between vaping and seizures. Some people are claiming to have had seizures as a result of vaping, which is a big deal. As of this weekend, I may be one of them. No doctor is going to give it the time of day, but there is a chance that my seizure as well as those of other vapers may have been caused by either a large intake of nicotine, a sudden reduction in nicotine, or possible metal poisoning from tiny metallic particulates given off by the heated coils – kanthal, nichrome or other metals used to make the coils. I don’t build my own coils, I use tanks that require factory-made coil heads. I have no idea what metals are used to make these coils (I personally exclusively vape on the Aspire Nautilus Mini tanks). Time may tell, but my life is ruined now because of this.

    • Carl V Phillips

      Well, to clarify, the researchers were not quite so sophisticated as to be drilling down to vaping behavior. They just noted that for subjects who were blowing clouds, their efficiency was as low at 50% or so. Actually some of the (dumb, public health) presenters were laughing about their brilliant discovery that “competitive vaping” (I think that is what they called it) exists. As I have said before, these people act like Victorian era British “researchers” out among the wogs, who think they are so superior to the subjects of their study that they will make declarations about their behaviors without even bothering to ask them (fellow human beings) to explain their experiences.

      As for the seizures, obviously that is serious. It would be a mistake to assume that the cause was vaping. Coincidences happen. The nicotine delivery is less intense than that from smoking; nor are seizures that on the list of symptoms of nicotine withdrawal. Inhaling a few bits of metal from an ill-made device, while certainly not good for you, also seems a unlikely cause — that happens to people all of the time in many environments. Also, if this were remotely common (and by that I am talking a mere 1% of users), it would have been noticed. Of course these observations do not rule out a possible causal relationship, but they make it seem unlikely.

    • Loved your comment about your life being ruined,I thought it funny,but then others may think i’m weird!Like your choice of Nautilus Mini,I’ve been using this system for quite a while now,and I can’t find any to beat it in that class! I’ve often thought to myself,when I’ve heard of having a fit during vaping,if it’s actually caused by hyper-ventilation,eg: continuous deep draws for cloud chasing.Do you have any thoughts?

      • Chuck Palmer

        As for my life being ruined, I hardly find that funny. If you ever develop a seizure disorder, you will see what I mean. You are not allowed to drive or operate machinery. That pretty much limits a shtton of jobs, especially when you don’t live in a large metro area. Even if you find a job, you have to get there somehow and when you don’t live in a large metro area, driving to a job can mean 30 mins and 40 miles. Even if you are free of seizures after 6 months and you are cleared to drive, if the cause of seizures is never found (and it usually isn’t in late-onset cases where the tests all come back negative), then you will never feel comfortable driving ever again as you and your car become a time bomb. I am now looking into starting an online side business and looking for work-at-home jobs. I will never drive comfortably ever again once I am cleared to drive by the doctors and the state.

        As for hyper ventilation, I don’t know because I don’t do lung hits. I didn’t smoke that way so why would I vape that way?

        What do you mean by “having a fit”? Are you talking about seizures? Have you actually heard of people having seizures while vaping?

  2. Thanks for all of your hard work and for posting the link/part that many of us missed yesterday. Good lord, it must have been torturous for you to sit in that room. It was (borderline) torture for me to watch it. Thanks for representing all of us not so “little” people.

    • Carl V Phillips

      It is good to be part of something that matters. Those people doing their silly little perceptions and propaganda studies will never understand that.

  3. Glad to see that you are alienating PH from THR by being unnecessarily controversial.

    • Telling a PH crowd heresy about nicotine addiction will make them automatically want to oppose your other positions, ask any sociologist
      (like Chapman).

      • Carl V Phillips

        1. I think you are confusing sociology and psychology.
        2. If the purpose of giving a talk is to win over people who are paid to oppose your position or have some fanatical opposition to it, then you might as well not bother to show up.
        3. I just go where the science takes me. I am a marketer to some extent, true, but I am not a propagandist.
        4. In any case, I actually don’t think that particular position is going to alienate them and might actually provoke some thinking among the somewhat opposed (not the moronically opposed, of course). Pointing out the heresy that nicotine use will inevitably return to being normal might solidify opposition — though it also might provoke realism (but whichever it is, I follow the science). But pointing out, to people who never even think to question the blind unthinking recitation of the unscientific “addiction”, that there is not there there, and that even if you quasi-define addiction as “what smokers experience” it does not apply to vaping, could have some positive impacts on those who actually have a brain and are not paid to turn it off.
        5. When launching into that style of arguing/complaining, it is kind of lame to hide behind anonymity.

  4. 1. I did confuse the two.
    2. Even many who are not paid to oppose the THR position and have no fanatical opposition may view with anathema and/or misunderstand the position that nicotine is not addictive. Usually, only in-group minority views have a chance to get accepted by the majority. It is crucial not to be seen as outsiders by PH folks.
    3. Agreed, but what’s the goal?
    4. I do not think you were given enough time to cause rethinking of a deeply entrenched position on addiction (and because according to widespread usage many people are addicted to coffee you are likely to be misunderstood).
    5. True. I have my insecurities and It”s your right to reject such comments.

    • Carl V Phillips

      2. Someone who never hears anyone question the orthodoxy they blindly accept will never — unless they are a serious intellect — question it themselves. Hearing that someone disagree, then, can only move them in the right direction.
      3. No goal there other than seeking the truth. That was my point.
      4. I totally agree that there is a lot more to be said. But the spirit of 2, above, is that hearing something is better than hearing nothing.
      5. I will not reject comments for anonymity if they are substantive and on topic. I made my point.

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  6. Carl, I believe there is actually quite a reasonable chance that, in a normal commercial public situation such as a well-ventilated restaurant where (at most) 30% of a future adult public might commonly vape, and where most of the vaping would likely be done after the meal and over drinks, the EVE (Environmental Vape Exposure) would most certainly be down on the order of 1/10,000th of what the vaper is absorbing. From my own research on ETS in such situations, I would say there’s a reasonable chance it could even be significantly lower.

    Why do I say that? If you examine my modeling in Brains or TobakkoNacht where I examine the exudate into room air from smoking and its dilution into that air after taking into account the volume multiplier introduced by the air changes per hour. With vaping there are two changes that should be made to factors in those models that are relevant.

    (1) If the venue were smoke-banned, the ventilation/air-exchange rate would likely be drastically cut down from the smoking norm as an invisible cost-saver. It might be slightly increased upon the introduction of vaping, but, as the owners realized the visible vapors and any scents from vaping rapidly disappeared on their own, it would likely be reduced to about half or even a quarter of the normal smoking-allowed levels. This change would serve to increase exposure of nonvapers by a factor of two to four, so I think three would be a fair expectation.

    (2) On the flip side, and BY FAR more significant in the modeling, is that fact that in the smoking models, most of the environmental smoke contribution, at least two-thirds to three-quarters, is contributed by the “sidestream smoke” (SS as opposed to MainstreamS) from the “idling” cigarette between puffs. With vaping there simply is no “sidestream” vape.

    But, let’s go with your 1/10,000th figure for the moment. It’s important to remember that it’s 1/10,000th of what the VAPER is getting… not 1/10,000th of what a smoker is getting. Clearly there are all sorts of confusing side considerations comparing nicotine and PG and VG and CO and “the 103,172 chemicals in tobacco smoke” (or whatever number they’re spouting nowadays), but overall I’d guess that a fair estimate of the “threat” from “secondhand vaping would be on the order of at least another hundred times less when compared to the “threat” of direct smoking.

    This would lead us to a threat ratio of a full one million times (comparing secondhand vaping to actual smoking.) Since the Antis claim in their SAMMEC fantasies that there are 400,000 or so deaths per year in the US from firsthand smoking and 50,000 from secondary smoke exposure, then similar modeling would lead us to conclude there would be slightly less than one-half of a single death per year from secondhand vaping if everyone took up vaping instead of smoking. Compare that to 100ish deaths from lightning strikes and 7,000 deaths from aspirin poisonings.

    – MJM, who will refrain from citing the frightening statistics on deaths due to parakeet bites and maulings by fluffy kittens.

    • Carl V Phillips

      The room itself “breathes” in the order of 1/100, and for a small room and lousy venilation you could definitely imagine someone else in the room breathing a fully 1/100th of that effluent before it was gone. So 1/10,000 does not seem like an absurd worst case. I did note that was the worst case. I am sure that Burstyn or someone could improve upon my estimate.

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