by Carl V Phillips
I think I have come up with a good description of the functioning of the FDA Center for Tobacco Products: Weaponized Kafkaism. The term is fairly self-explanatory, but to unpack it: Kafkaesque is, of course, refers to a system that brings to mind the situations faced by Franz Kafka’s characters, particularly including being trapped by a baffling and inscrutable system (particularly a government bureaucracy), where one is punished for doing something wrong as a result of having no idea what would satisfy the authorities, and as the rules begin to become apparent they are revealed to include self-contradictions, making it literally impossible to comply. (I converted the word to its seldom-used noun form.) Weaponization refers to taking something that in its “natural” state is harmful or potentially harmful, and then intentionally deploying it in order to do harm.
The description came to mind in light of the chatter that followed this New York Times article about lobbying efforts to soften the impact of FDA’s deeming regulation. (Note: Do not read the article unless you are already expert on the politics of the situation, and therefore read it for the purposes of observing how the NYT and the actors are spinning things. As is typical for mainstream media coverage of these issues, if you read it in an attempt to actually learn about what is happening, you will know less when you are done than when you started.) The emphasis in the article was on Altria’s leading role in the lobbying effort, which was dramatically overstated to create the narrative the NYT wanted, but still substantially true. This article resulted in cognitive whiplash for those who have believed that the deeming is a gift to “big tobacco” and other over-simplifications of the situation. What is Altria up to? Are they altruistically standing up for real public health despite their own financial interests? Or trying to put on a show of doing so for PR purposes? Is this all NYT politics and click-bait, and not actually real?
There is another compelling explanation: This is a rare opportunity to fight back against the Weaponized Kafkaism that is CTP. As I have recounted on this page many times, when it comes to the only thing they actually do (ruling on — usually rejecting — various applications), CTP is utterly arbitrary and Kafkaesque. There are no stated rules that companies can try to obey, and applications are often rejected based on failing to do something that had never before been identified as required. Large incumbents in (any) industry are adept at taking advantage of onerous regulations for competitive advantage. Even when the company might actually do better (and consumers probably do a lot better) without a regulation, the actual humans who comprise the company have a much easier life if they can just obey rules that disadvantage potential competitors rather than doing the hard work of competition and innovation. But that does not work so well for them when the system is Kafkaesque.
When the system is Kafkaesque, the legal talent and manufacturing precision that a big company can muster do not guarantee they can just obey the rules and thrive at the expense of potential competitors. The stress of competition is replaced by the stress of living the life of Josef K. The anti-“Big Tobacco” (or “Big Whatever”) nutcases, who favor anything they perceive to be anti-industry regulation no matter how harmful it is otherwise, almost always get played because they are so dim, ignorant, and faith-based compared to the informed and savvy actors in business. The latter almost always make the rules work out in their favor. But with Weaponized Kafkaism, the antis have stumbled upon something that actually creates headaches for the big incumbents instead of just gifting them protected market dominance and easy profits. That is the terrible beauty of Weaponized Kafkaism, throwing sand in the gears of free markets and innovation without providing as much comfort for the big companies as proper regulation. Note that this system still gifts big incumbents some protection and profits, but imperfectly and unreliably, and it imposes stress and uncertainty that they do not like.
Note also, as I recently explained, that the Tobacco Control Act does not appear to have been intentionally designed to be Kafkaesque (after all, Altria was the co-designer of the TCA and most incumbent companies saw it as a neutral-to-positive turn of events). The authors seemed to believe they were actually creating a regulatory system, not a random mess. But it immediately became apparent that the new CTP did not have the talent to create such a system. Soon after that it became apparent to the anti-industry people that this was just fine. A pity that CTP was doing nothing to actually improve public health (other than, perhaps, the effects of preventing improvements in the quality of cigarettes), but hey, they were creating a lot of stress for the industry. So instead of trying to get their act together and become a proper regulator, CTP leaned into it and weaponized the Kafkaism that was inherent in their startup chaos: they write “Guidance” documents that offer no useful guidance; they make arbitrary decisions; they say one thing and do another; they string along a list of potential actions they might or might not take; they produce “research” that is such a hash it could be used to rationalize anything; etc.
Or, perhaps, this outcome was secretly planned all along, and this was a rare case where it was the industry that got played.
So what can Altria accomplish via fighting the deeming regulation? If they can shine some light on the whole Kafkaesque process, there is a decent chance that it will not be allowed to continue as is. That could help their core businesses. It is difficult to get much traction — politically, and even in the courts — with “they will not even tell us the rules for how to get a better cigarette approved!”, or even “…a better smokeless tobacco product….” But for a variety of political reasons, e-cigarettes have become the darling of numerous “think tank” factions in Washington politics, and they can use that. If the rules that apply to all products are declared to be unacceptably Kafkaesque for the case of e-cigarettes, then that spills over to benefit their other products.
I realize this sounds a bit akin to the mad ravings of tobacco controllers, that everything about e-cigarettes is just a plot to encourage smoking. But unlike their demon-worshiper faith-based claims (as in, “advertisements for Blu are intended to sell more Marlboros, because the entire industry is just a unitary demon whose goal is to sell more Marlboros”), my assessment is based on understanding how the world actually works.
The attempts to change the grandfather (predicate) date for the newly deemed products, grandfathering in products that existed through 2016 rather than requiring all products to go through a de novo approval process, is a perfect example. As I have noted from the start, that amendment is a poison pill for e-cigarette deeming. Despite this being obvious (and having been explained for those who do not find it obvious), it is pretty clear that most of those who oppose the amendment, and almost all who support it, do not get it. But you can be sure that Altria and CTP understand it.
If tens of thousands of e-cigarette products are grandfathered and need to be “regulated”, rather than just banning the category back to a level that can be handled with Kafka-as-usual, the failure of the system across all products will be evident. CTP will face hundreds of lawsuits over approval decisions, brought by sympathy-generating small companies facing an existential threat. (Those companies could not afford to seriously attempt new products approval and so would just disappear without recourse under the current deeming plan, but could afford to litigate later FDA decisions that would put them out of business if they were not simply precluded from selling anything.) This is quite a bit different from “evil” big companies taking them on, especially when the system works just well enough that they would really prefer to grumble and just try to keep playing ball. Imagine the delight at Altria, getting all the benefits of litigation that forces CTP to fix themselves without having to deal with the cost, bad will, and innuendo.
As a bonus, this could put a reasonably robust e-cigarette market under an onerous but navigable regulatory regime that would benefit Altria and a few other big producers, for all the usual reasons stringent regulation does that. This contrasts with the realistic outcome from the deeming as currently written: black markets, legal markets for most non-nicotine open-system components (it seems likely the court challenges to FDA’s attempt to ban them will succeed even if no other challenges do), expensive new product approvals for a few mass-produced products with ossified tech, and so on. That is not so good for the major producers.
Most commentators on FDA in the e-cigarette context seem strangely unaware of how CTP functions and how much the legacy industry would like it to actually function as a regulator. The stakes for them, in de-Kafkaizing the weapons deployed against them should not be underestimated. I cannot say that I know what the Altria executives would do if they had some demon magic available that could eliminate e-cigarettes from the world; maybe they really would make the evil choice in that case. But given their realistic options, it is not difficult to work out that a highly-regulated but robust market that also helps sweep away some of the Weaponized Kafkaism throughout the sector would be a dream outcome.