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.]

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14 responses to “FDA Center for Tobacco Products (mostly) know exactly what they are doing.

  1. the industry needs to look at tomatoes for an unregulated source of nicotine – somewhat more expensive but I’m guessing that tomatoes will never be regulated as tobacco is. Let’s get together and get smart about this.

  2. “This week CTP tweeted that the deeming regulation now made selling all tobacco products to minors illegal.”

    CTP is wrong. As far as federal law is concerned, tobacco products can still be sold to minors if they don’t contain tobacco or nicotine (what a strange world where that sentence makes sense). Vaporizers, e-cigarettes, hookahs, zero nicotine e-liquid, etc, can still be sold to minors without violating federal law.

  3. “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.”

    This is the perhaps most insightful thing I’ve ever read about the workings of big government. The same thing can be said of most “comprehensive” programs. Yet they/we keep doing it, expecting different results.

  4. What you are really saying is that you don’t believe a bureaucracy can be that incompetent. You finish with a reductio ad absurdum argument (no-one is that stupid) bolstered by an argument from incentives (what they are doing works for them). Not a bad try.

    However, a couple of things work against this thesis.

    Actually, it would take quite a powerful conspiracy to do what they are doing knowingly, and a degree of professional discipline and enforcement that they show no sign of having. You accept this by recognising the multiple legal barn doors they have left to aim at, and you have also had a lot of experience of just how weird and deranged their comms are. I just don’t think they have the competence to do proper professionally evil things. You think more highly of their capabilities than I do – that’s generous on your part, but I don’t see much justification for it. Try spending some time in a really stupid bureaucracy (as I have) and you’ll see how the aggregation of many intelligent people can produce emergent stupidity without anyone involved realising that’s what’s happened or feeling even slightly responsible.

    As for the argument from incentives… I doubt that those involved have the insight and reflexivity to see what you see, which I acknowledge is a good objective account of their actual self-serving incentives. I would see it more like the way religious fundamentalists misperceive their real incentives – they think they will be blessed in a Rapture, but actually they are loser-fantasists pursuing unworldly escape to their own detriment. My guess is everyone in FDA and CTFK really does think they are saving kids, fighting rapacious capitalist drug dealers and using the power of the state to make everyone better off. It is to these collective cultural delusions and their many reinforcers that I would look first.

    Your theory gives them so much more credit than mine, which is why mine is more likely to be right.

    • Carl V Phillips

      Hmmm, I don’t think that last bit qualifies as a legit argument.

      Re conspiracy and true believers in the midst: I don’t see why any of this would take a big (and thus leaky) conspiracy. No more than a few people at the top openly discussing things in a tight group could pull all this stuff off. As you implicitly note, most of the useful idiots could be sold with the same rhetoric that sells those outside. But it would not even take that for most — perhaps all — of the observed outcomes: Approving SE applications for packaging changes in order to stake out unauthorized jurisdiction over them — literally only one person of rank would have to figure that out, and not even mention it, and then tell the staff to get it done because there is no harm there. Ban the new Stonewall flavors to sabotage harm reduction and set precedent for not worrying about big picture consequences — same.

      Approve non-menthol Newports — not a word would have to be said, since every major individual must have recognized it was necessary if they were to move forward on Menthol. (Now why they crashed and burned on moving forward with Menthol — that is more complicated.) Doing the deeming in a way that gives them some hope of being able to deal with it — kind of the same as that. Workaday people do not exactly need to be sat down for a meeting to be warned that if X is demanded of them, their jobs are going to get a whole lot tougher — that is a pretty natural instinct.

      Planning and tacit agreement like this takes place all the time without anyone ever quite saying it, with all the on-the-record talk being True Believer stuff. Anyone who does not catch on can be the target of a little one-on-one explaining, with no witnesses. One has to be awfully intent on burning down the house (which no one has seemed to be) to go public with undocumentable whistle-blowing about such things, on the off chance that anyone will even give you ink for it.

      Yes, groups do create stupidity beyond their members sometimes — the anti-wisdom of juries and all. That is something that can explain creating Rube Goldberg legislation that does not work and writing important documents that you or I could have done a better job of in a couple of weeks. But keep in mind that there is a hierarchy and those at the top are pretty clever individuals. It is unlikely they would miss the big easy points (so, ok, the Stonewall thing might have been random, but not the others). There is a big difference between being able to craft the perfect sneaky details and being able to just aim in the right direction.

      And, no, the bit about them not believing what they are saying (and I am talking about the top few people, the only ones who are allowed to speak officially) is not reductio ad absurdum. I am actually not even sure how that could apply to what I said. But in any case, it is not based on any kind of abstract inference or blanket faith in human intelligence, but having watched, listened to, and talked to the particular individuals in question. This is not the “look what this random idiot professor or medic said in the newspaper” stuff that populates much of the discourse. It is about particular individuals with actual authority that they take seriously. They are not stupid. They read (or get briefed on) a lot of stuff. Myers may well be so far up his own echo chamber that he doesn’t. But Zeller? Ashley? Backinger? No, I am pretty sure not. They know most of the problems CTP claims to be fixing do not exist in reality. They know there will be a black market. They understand that federal age restrictions that are redundant with state laws are not great accomplishments.

      • Think you don’t need much more than a ‘autonomous’ peer review structure one where the chair of the board remains the same person(or persons) for decades , combined with it being an area that is insulated from real world public failure ( i.e its not ‘aircraft design’) for the sort of things you are both describing to become all persuasive.

  5. Riiiiight.

    “Since taking office, President Obama has been committed to eliminating red tape and ensuring that when rules are issued to protect safety and health, they are sensitive to the economic situation and attuned to the importance of job creation and economic growth.”

    https://www.whitehouse.gov/blog/2012/08/07/smarter-approach-regulation

  6. If I got this right, Carl, (and perhaps I didn’t) you seem to be saying that they purposely winnowed the legal market down to something they believe they can control with full knowledge that the black market will thrive but can shrug and say innocently “it’s not our job. ”

    If so, I (most respectfully) disagree. I think all bureaucrats and legislators genuinely and egotistically believe that once they “lay down the law” that few will have the courage or the effrontery to flout it and 98% of everyone will comply by intimidation or force. Problem solved. (Just imagine Volstead’s surprise in the 20’s.)

    No, in their profound zealotry, I believe they’re going for The Final Solution To the Smoker Problem–killing not just smoking but anything that resembles it (nicotine or no) and anything related that might be seen by anyone as connected to pleasure.

    With that in (their) mind, they sincerely want to kill vaping by limiting the market to dated and less satisfying choices , and by criminalizing any other choices.

    • Carl V Phillips

      Yes, you basically captured what I meant. And you also pointed out a step that I did not mention in this particular exploration of motives: Intentionally lowering the quality of all tobacco products as part of a creeping prohibition. They indeed do that every chance they get. That is part of their core tactic of trying to ratchet away at people’s options.

      The ban of most products is then the next step after that in the story: They could theoretically do it the same way they do with other products, merely stopping consumer-friendly innovation. Except they can’t because they cannot handle a market that is the current size.

      I think a lot of the disconnect here is not recognizing that these are people who have been living the tasks they have to do (or fail to do) for years. They (or their immediate predecessors whose experience they are aware of) have experienced being overwhelmed by the first rounds of SE applications. They are confronted in their work with the black market in cigarettes and are as aware as anyone of the black market in banned drugs. They do not have to possess brilliant insightfulness (of the type that might be needed to design a working system from scratch) to figure out what is beyond their abilities. An outside observer, corporate manager, or new employee at a warehouse might not be able to note that two particular items cannot be easily carried at the same time, or that one of the shelves is badly positioned; but the average guy who works there a while will inevitably figure it out. So perhaps Sec DHHS might say “just do it this way” and be clueless about that not being possible, but not the people on the shop floor.

      I believe that the “they will just do what we say” delusion is similarly unlikely. They have already seen the black market in cigarettes. These are not clowns like Glantz or Chapman who have no responsibilities and don’t have to ever get anything right, so can wallow in their delusions. Distant ideologues can talk themselves into things like “they will greet us as liberators” in the abstract, to rationalize their real goals, but someone who has been on the ground a week will figure out it is not so (indeed, chances are he will err in the other direction, of thinking the situation is more intractable than it actually is because he is constantly confronted with the difficulties — but that error would further go in the direction I am arguing).

  7. Your post creates an interesting opportunity. There a rather longer response than a comment will allow: http://wp.me/p6ecKh-3P

  8. Pingback: Weaponized Kafkaism | Anti-THR Lies and related topics

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