FDA Center for Tobacco Products (mostly) know exactly what they are doing.

by Carl V Phillips

Clive Bates recently posted about the e-cigarette deeming regulation which started to take effect this week. Most of the post is just the 10,000th thing you have seen, dating back to before the first draft of the regulation was released, about the unfortunate consequences[*]. But in the last line he says:

I’m prepared to believe they aren’t doing it deliberately, but I just have this feeling that the big players behind the FDA’s intervention, such as Mitch Zeller and Matt Myers, do not have the faintest idea what they are actually doing.

It is a reasonable starting assumption. Never assume malice when incompetence or laziness would produce the observed result. In the comments that followed, however, enough people asserted disagreement (albeit largely without analysis) that Bates tweeted in search of anyone who agreed with his assessment. I am afraid I am going to half-disagree also, or perhaps mostly disagree, though it takes some analysis to get there.

First, we need separate the crafting of the Tobacco Control Act, which created the Center for Tobacco Products, and the current behavior of CTP. The TCA accomplished what it was supposed to at the big-picture level, while being a “not the faintest idea”-level failure at the detail level. The big-picture goals of the TCA were:

1a. Do something to please the various anti-tobacco busybodies and federal legislators who were screaming “do something!” without doing anything that would evoke serious opposition from not-anti-tobacco legislators.

…which is roughly equivalent to…

1b. Inflict substantial harm on tobacco product users, along with modest hassles for the producers, while creating barriers to market entry so that the main organized interests in the space (the incumbent major tobacco companies) favored the law.

2. Create some modest restrictions and a create a base for further operations, as per the standard nanny state script: Impose any restriction on people’s choices that is politically possible at the moment, reasonably counting on it ratcheting, before moving on to the next restriction.

3. Impose various hidden taxes on consumers and capture the money as patronage payments for tobacco control supporters.

4. Counter efforts to promote harm reduction by effectively denying different tobacco products, with their different levels of risk should be treated differently, as well as by inflicting further caused-harm on consumers.

All of these were successful. However, at the detail level the TCA was an incompetent clusterfuck, and while that has worked out just fine for the tobacco controllers and does not interfere with the above list of primary goals, it does not appear that was by design. The law contains many details about completely failed processes, such as applications and approval systems (SE, MRTP, PMTA) and assessing and regulating the chemical composition of products. As I have recounted numerous times, the approval processes are utterly dysfunctional, and have simply been a series of arbitrary ad hoc decisions. The chemistry and other scientific goals have gone nowhere. The TCA did not facilitate the creation of the necessary infrastructure to do what it claimed it would do.

The CTP that was created cannot (and thus, of course, does not) function at all as a proper regulator. It reminds me of corrupt third-world frontier guards who are just levying fees, collecting bribes, and making self-interested decisions about whether to allow passage. This week CTP tweeted that the deeming regulation now made selling all tobacco products to minors illegal. I replied by congratulating them on doubling the number of real regulatory actions they had taken in their seven-year history. In reality I was being generous, since the new rule is basically redundant with state laws.

Of course this still fails to answer the incompetence-vs-design question.

My assessment is that all those detailed rules and processes would not have been written with the expectation that they would not function at all, and would merely serve as acts of market sabotage. Those goals could have been accomplished with far less detail. The details clearly feel like an attempt to create something, whatever the motives, rather than to create a morass. So here we have a case of pure incompetence: people designing systems that simply did not work. The key problem is that they violated one of the rules of making good public policy, incrementalism. They tried to design an untested system that was a huge departure from the status quo or anything that anyone had worked out before, rather than testing smaller steps or creating the foundation for an evolving system. Of course it failed. The fundamental incompetence was not being bad at designing systems, but not understanding that almost no one is good enough at designing systems to be able to pull that off.

That is the story of the creation of CTP. What about the current behavior of CTP?

There I would say they know exactly what they are doing at the level of impacts, though they are remarkably bad at the games they are playing at the detail level. The application and approval processes were designed badly. But CTP has taken advantage of that to hand-pick exactly the approvals that serve their goals (interfering with THR, mission creep, making sure future bans were politically palatable). On the other hand, they have been needlessly ham-handed about it (letting applications languish for years, offering really stupid rationalizations for decisions when it would not have been difficult to say something more defensible).

I would say the same about e-cigarette deeming. Yes, many of the details of the deeming regulation look like they were written by interns or out-of-touch activists rather than the savvy lawyers and career operatives that CTP has. These have opened all manner of possible legitimate legal challenges that need not have been left open (some — but not all — of which the current lawsuits take aim at). Their failure to secure their own gates against obvious legal challenges can only be seen as incompetence.

But as for the broad sweep of the deeming, those supposedly “unintended” consequences are exactly the sensible thing for CTP to be imposing. CTP has developed no capacity to actually regulate, nor any apparent capacity to develop capacity. They consist of a bunch of highly-paid people who have no particular responsibility. They show remarkably little knowledge about the simple products they were originally charged with regulating, and e-cigarettes would represent a more-than-doubling of how much they need to understand. Therefore, a regulation that bans all e-cigarettes other than a few fossilized closed systems is exactly the rational thing to do.

I trust it is obvious that I mean their action is rational in terms of their own personal selfish interest (with the added bonus of pleasing the anti-tobacco busybodies). Obviously it is a terrible thing to do from the perspective of the people’s well-being, good government, public health, and so on. Our government’s agencies get a lot of criticism implying they are like the stereotypes of patronage backwaters and department of motor vehicles offices from c.1980. They get undeservedly accused of not trying to serve the public interest merely because they (inevitably) do so imperfectly or in a way that does not fit a critic’s personal political goals. But sometimes the stereotype fits.

The current rules are bad for harm reduction, but that is a feature for CTP, not a bug, because they are demonstrated opponents of harm reduction. The rules will replace a thriving legal market with a thriving black market. But that is exactly what CTP needs because they do not have to deal with the black market beyond sending out a few cease-and-desist letters when something becomes too glaring to ignore. They lack the capacity to regulate the legal market. They could not even process all the product registrations for all e-cigarette products, let alone do anything of substance. So their only (self-interestedly) rational choice is to pare the legal market down to a level they can handle. (Note that this does not imply they will handle what remains in an informed or public-interest manner, but at least they would have the capacity to create an illusion of doing so that will fool non-experts.)

None of that will come as news to anyone who has paid attention to what I have written on this topic for the last two and a half years. But because most of the stakeholders and pundits in this area do not pay much attention, they can be persuaded by CTP’s sort-of-pro harm reduction rhetoric, claims that the black market will be minor, and so on. At the very least, they can be persuaded that CTP really believes their own statements.

But I find it impossible to believe that CTP actually believe what they are saying. When looking at the statements, we are not talking about someone taking on a task and not being competent to pull it off. We are not talking about the musings of random Dunning-Kruger-ized “experts” who have spent a few tens of hours reading about the topic. We are talking about a simple matter of understanding, and about professionals whose full-time job is working on this. Assuming incompetence is a good default hypothesis, but the sheer enormity of the required incompetence in this case, along with the fact that the outcomes are in the actors’ selfish interest, argue strongly for “know exactly what they are doing”.

[UPDATE – an extended footnote that is a bit of a mini-post on a different topic: In response to Clive taking some offense at middle sentence of the first paragraph, I wanted to expand upon it. I am not sure whether this will eliminate the offense, but at least if offense remains, it will be based on what I really think, rather than an attempt to interpret those few words.

It is true that this was motivated by me not wanting to recommend reading the post. Please note that this contrasts with 90% of Clive’s posts which I strongly recommend. This includes the ones I take issue with — they are still worth reading. In this case, however, I was basically trying to placate my own not wanting to link to a post that I did not recommend. I felt like I had to say something, even if it was impenetrable.

Why did I feel that way? Part of it is my concern about the flood of generic “deeming [or whatever restriction on e-cigarettes] is bad because it encourages smoking” posts. Even when there is nothing wrong with the content, I feel like the churning of the generic message is contributing to a harmful echo chamber. Moreover, I think the hundreds of monologue posts written without reference to what has been previously figured out create further harm by under-informing readers about the knowledge base. There are way too many commentators (Clive not among them!) who try to write big-picture analyses when they would be much better off just posting “go read this which someone else has already written”, rather than badly reinventing the wheel as an act of self-indulgence, and thereby leaving their readers believing they have a better understanding than they do.

There is a tiny fraction of what is written in this arena that I would ever recommend reading. This probably consists of many works that I never actually recommend because I do not see them. That too is part of the problem: there is so much pabulum that important new insights get lost. Note that the preceding is generic observation; Clive is one of those who advances knowledge, presents new observations, and draws upon and references the knowledge base. So read his stuff if you don’t. Still, because of these concerns, my default reaction (to tie to a theme of the actual post here) is that such a post does little good and possible harm.

(Note that this refers to insider communications. If you want to write something for a newspaper, or slip it in as an off-topic post in your blog about dog training, thus reaching a new audience, by all means do it. But if the only people reading something are already well-read in the field, then more generic broadsides are not useful.)

So, taking this back to the particular post, what did it contain. The content was mainly quotes from the RCP report and a security saleswoman. The former quote was standard generic stuff, but it was anchored on an actively harmful misuse of the concepts of precaution and risk aversion. (This misuse suggests that restrictions on e-cigarettes have potential legitimate justifications that they really do not.) The latter author is has a rather, ahem, dubious record of making proclamations that are wrong and/or based on nothing.

But the real problem here is the tendency — common in public health as well as poor journalism — of suggesting that something is informative or persuasive just because it was written down. Clive is more of an expert on these matters than either the authors of the RCP report or the banker. He could make better and more authoritative statements on these exact points than those he quoted. Indeed, he has done so. Thus the presentation of them mainly serves as an endorsement of the toxic mentality of “I believe something; someone else wrote down a generic brief assertion of the same sentiment; therefore my own opinion is vindicated”. (For a good example of why this is so toxic, see Clive’s own next post.) It is especially toxic when it is done by someone whose analysis should be more trusted than those he is quoting.

Anyway, I was not sufficiently motivated by that to write this as so much as a comment on Clive’s post, let alone write a post about it. However, since this turned into a Twitter discussion/debate, here it all is.

End update.]