FDA reveals its views on ecigs in new publication

by Carl V. Phillips

[Update: This post begins a series that continues with part 2 and part 3]

The new special issue of the “journal”, Tobacco Control, has already been cited as a comprehensive review of what is known about e-cigarettes.  It is very much not that.  A glance at the table of contents makes this clear (hint: if a collection does not include among its authors any of the leading experts, it probably is not a comprehensive review) and further reading confirms it.  What it is, however, is something far more useful than that, and far more troubling:  It is effectively a position statement by the U.S. FDA, the institutional author of all the papers, about how they feel about e-cigarettes.

(Note that the contents are genuinely published — open access — unlike the typical paywalled ANTZ articles.  Credit to the US government for requiring that for writings that we pay for.)

As I noted in my recent comments on one paper, sometimes a statement is not all that revealing about reality, but can serve as a study of the authors themselves.  Most of us figure out, by about age five, that just because someone wrote something down does not mean it is true.  By age twenty we also ought to be aware that this is no different if they happen to have written it down in an academic journal — especially (though certainly not exclusively) if that “journal” is really mostly a partisan house-organ.  But such writings always tells us something about the people who wrote them.  Most of the time we do not really care about the opinions of those people, so this is of little value.  But when they are the FDA Center for Tobacco Products, the people who are likely to soon be regulating e-cigarettes, it is quite interesting.

Tying together these themes, anyone who suggests this is a comprehensive review is telling us something about himself:  He does not know enough to know what a weak review this is and is apparently unaware of that “just because someone wrote something down…” principle.  Moreover, he does not seem to realize that when government officials publish something, it is always about their policy opinions and plans, not neutral information provision.

Of course, when the opinions are delivered in the form of what the authors believe are the facts (or, more precisely,  are officially declaring to be the facts — regardless of actual belief), it requires a bit of study.  A position paper from FDA would be more transparent, but they have carefully avoided providing that, so this is what we have.  The following is an assessment of what that content means.  Apologies for it being a bit scattershot and following their organization structure rather than something more systematic; trying to digest it all and address it more systematically would take far more time than I have at the moment.

The first observations are those I already made:  It appeared in Tobacco Control, a publication that cares little about real science and is of, by, and for prohibitionists.  Moreover, this review of the available evidence apparently relied entirely on whoever happened to be employed by FDA, making it clear that this process was not about seeking the truth, but rather creating the “truth”.

The introductory paper tries to establish the importance of the topic by referring to markets, media, “public health”, and regulators.  Notice who is missing?  Yes, that’s right:  the consumers, the people who government regulation is supposed to help.  This is not news, but it is telling.  Presumably this was completely unconscious.  The tobacco regulators simply do not believe the consumers matter.

The paper begins,

Electronic cigarettes (e-cigarettes), the most common type of electronic nicotine delivery system (ENDS)…

Credit to them for using the correct terminology in their article titles.  However, they prefer the unethical term “ENDS” in the body of the work.  Or perhaps no credit: they put the real term in the titles to attract readers, but use the unethical derogatory term preferentially in the text.

I have to say I am a bit curious about what other products make e-cigarettes “the most common type”, rather than the only type.  (Are they counting cigarette vending machines, as I suggested in the previous post?)  This first sentence in the collection does not inspire confidence about their understanding of the world.

The most important observation about the introductory paper is the emphasis on how e-cigarettes, and what is known about them, can be used to create better government controlled (my words) nicotine products.  That is, even the good news about low risk and high appeal is being interpreted in terms of how the free market can be shut down.

There is also a hint that FDA will push back when they discover that more people will choose use low-risk tobacco products than currently use cigarettes.  I say “when”, though they say “if”, because I have shown at length that this is inevitable.  I have pointed this out personally to FDA, but they seem to either not get it, or they are intentionally trying to set up this inevitability as an excuse for imposing restrictions.  I am afraid the latter is more likely.

There is not much more to say about the introductory paper.  It is a typical example of the term-paper level attempt to summarize this complicated topic with one-sentence versions of points that cannot be effectively examined in a page.  It is better than most of those term-paper summaries, but because it is a summary, it necessarily comes across as naive and not much can be read into the simplification.  That is not so, of course, for the papers that supposedly summarize areas of scientific knowledge.

The first of these is about “product characterisation and design considerations” (and, yes, there is something odd about the U.S. government choosing to publish in a journal that requires British spelling).  The methods give us our first statement about the intentional naivety used in this review process, which focuses only the words from the ivory tower and not the immensely greater quantity of popular knowledge.  They base their understanding entirely on a “total of 14 [academic journal] articles and documents and 16 patents”.  Summarizing based on such paltry information perhaps does not matter so much for this “what they are” paper compared to those that follow.  But given how obviously out-of-date journal articles are in the world of e-cigarette product development, it is the clearest illustration that they are choosing to rely on patently incomplete information.  Not good news.

Though this is ostensibly a review of product characteristics, the authors’ conclusions are all about the familiar inflammatory statements:

differences in nicotine delivery and potential product risks. e-cigarette aerosols may include harmful and potentially harmful constituents. Battery explosions and the risks of exposure to the e-liquid (especially for children) are also concerns.

Again, this collection needs to be read as informing us about the FDA, not the products.  This statement and others related to us tell us that their[*] major focus in studying product variety is looking for reasons to lament about product variability.

[*While the U.S. government really should not use British grammar, I am free to use it where I prefer it.]

Their main conclusion that is not scary innuendo is:

A standardised [sic] e-cigarette testing regime should be developed to allow product comparisons.

That, of course, would be useful — so long as it was realistic.  The industry really needs to do this before someone who is intent on producing misleading information does so.

Most of the body of the paper is a general overview of the products, which is presumably useful for some readers (though no more so than hundreds of other such overviews that already exist).  But the key content here is the palpable sense of frustration of the authors.  They seem to realize (not admitting it, of course) that to really understand the products it is necessary to first get generally up to speed, and then to spend many hours a week keeping up with the advances.  They complain that there is incomplete knowledge, which is obviously always literally true about everything, but reading between the lines what they are saying is “we are frustrated that a term-paper level review of the easy sources of information leaves us remarkably ignorant.”  They may or may not realize that others know a lot more about this than they do.

If they do realize this, they presumably realize that to acquire expert-level knowledge of e-cigarette products requires reading beyond the ivory tower literature which is at least a year behind the highly dynamic reality, and usually more than that.  But even as they communicate their frustration with the review not being easy, they also communicate frustration with the product variability that even their limited information demonstrates.

FDA, unlike some regulators, is not used to keeping up with highly dynamic realities.  They are also not willing to let the market move forward and then try to fix its demonstrated failures after they become apparent, as most regulators of commerce do.  Instead, their usual practice is to force reality to slow down to their pace.  This paper — with its demonstrated unwillingness of FDA officials to spend the time it takes to understand the products — hints strongly that they will try to slow the pace.  They want to do that not just because they think that would make the world better (though they might think that too), but because they personally do not want to do what it takes to deal with it.

There are eight more papers, so obviously I am not going to finish this today.  To be continued.