FDA Joins Orchestrated Attack On Juul. Or Did They Start It?
The concerted attack on Juul brand products just reached its predictable first-act climax, with the FDA joining the attack with announcements, press statements, and enforcement actions (further details were previously reported). FDA Commissioner Scott Gottlieb published a statement alleging that Juul Labs is marketing to minors after making similar public comments. This was accompanied by email announcements and a social media blitz. The New York Times and Washington Post published party-line articles about this within minutes of Gottlieb’s statements, making clear that their endorsement of the FDA’s message had been pre-arranged.
A previous analysis observed that the recent popular press and political attacks on Juul, which focused on the brand’s supposed popularity with teenagers, was clearly part of an orchestrated campaign. That analysis addressed the questions of why Juul and why now, and it examined possible explanations for why tobacco controllers would choose to give one company so much free publicity. The name recognition has undoubtedly given the brand a huge boost at the expense of its competitors, and it has also encouraged more teenagers to try it. A recent academic paper by tobacco controllers lamented the extent to which teenagers, in 2015, overestimated how many of their peers vape. That bias is undoubtedly greater today than it was a few months ago, before the campaign began.
Gottlieb’s statement led with a notice that, following an investigation, the FDA had issued citations to 40 retailers for selling Juuls (specifically) to minors. As one commentator noted, that is probably less than the number of shops in a small city selling Marlboros to kids every day. Indeed, the available data shows that more teenagers smoke than have even tried a Juul. It seems rather unlikely that any retailer restricts its underage sales violations to vapor products, let alone to Juul specifically (“no, I can’t sell you smokes or that Vuse — here, try this instead”), but the theme of the day’s hysteria is all about Juul.
As noted in the previous analysis, this is a sensible (and deplorable) strategy. By pumping up a company — one that is not experienced at dealing with such attacks — tobacco controllers can create a paper supervillain. This justifies their funding and whatever policies they prefer without actually strengthening the opposition.
But whose strategy was it?
The FDA’s action suggests it might have been theirs all along, or at least they were party to it. Gottlieb’s statements were born whole; they did not trickle out in a catch-up reaction to media and political pressure as has happened in the past. The investigation into retailers must have been launched before the recent media blitz. It is possible that FDA was goaded into this by the quango tobacco controllers who fed the stories to the press. In that scenario, the agency rushed to develop a complete policy statement, reinterpreted data from a retailer investigation that happened to be underway to focus on Juul, and happened to have an enforcement action ready to go out the door. But the pieces seem to fit a little too neatly.
Less noticed than the public announcements was FDA’s document request to Juul Labs demanding information about their marketing practices, product design and related topics that include (presumably nonexistent) company research on youth behavior and public health. The letter states:
FDA is requesting these documents based on growing concern about the popularity of JUUL products among youth.
What is the basis for this “growing concern”? The letter continues:
JUUL product use appears to be common in middle and high schools based on widespread media reporting describing a rapid growth of use among youth in general and on school property….
This statement cites twelve popular press stories that were part of the campaign attacking Juul. That is, someone orchestrated media reports that exaggerated the extent of Juul use by “youth” and its appeal to them. The FDA then used the mere existence of these stories — in the absence of any legitimate research — as evidence of a problem.
What is also interesting is that the FDA did not actually need to provide any evidence or excuse. They have the authority to demand the documents, and could have stopped with the first sentence, or not even that. Yet they continue for a long paragraph sketching their supposed case against Juul. Their remarks include, “reports of youth use of JUUL products are of great public health concern and no child or teenager should ever use any tobacco product,” “nicotine affects the developing brain,” and “may lead to cigarette smoking.”
This is a very strange document request. The FDA is not petitioning a judge for a subpoena, in which case they would need to make an argument. They already have what is effectively subpoena power. Normally prosecutors and investigators do not explain to their targets exactly what they hope to show using the requisitioned documents. The FDA used the document request as an excuse to embed innuendo and substantive testimony in a legal document that allows no opportunity for response to the claims. It is extremely unlikely that FDA will find anything in the documents, let alone be able to make it public, that supports the “marketing to children” claims. Certainly there will be no trove of secret behavioral science research. So the FDA is taking their shots preemptively, perhaps with the intention of coming back and saying “since these issues were oh so concerning, Juul’s failure to have done any research on X is the real problem.”
Why would the FDA do this (even if “this” merely succumbing to pressure rather than being behind the campaign)? Several explanations are obvious and easy, and thus probably accurate to some extent: Anti-tobacco extremists, who captured the FDA’s Center for Tobacco Products from the time of its creation, are more worried about vaping than they are about smoking. The FDA overcommitted by trying to ban vaping in 2009, got burned, and are still trying to save face and get revenge by pretending it is a serious public health concern. And the growth of vaping gives them an excuse to demand more funding despite the decline of smoking.
But there seems to be more to it. The second paragraph of Gottlieb’s attack on Juul is a non sequitur about his pet project, banning cigarettes unless the nicotine is removed. A few tobacco controllers have toyed with this proposal for years, but it was never embraced by the FDA before Gottlieb’s tenure. The main beneficiaries of that policy are black marketeers, those who wish to make smokers suffer, and 22nd Century Group, a company whose value depends on whether anyone will be forced to license their otherwise worthless denicotinized tobacco. But another possible winner is any company that, like Juul, sells an alternative product that would not be included in the prohibition, and also does not have a cigarette business that will mostly be lost to the black market. This is especially true if the cigarette prohibition results in a ban of refill e-liquid, as it seems it will, even apart from the scheduled 2022 doomsday for all open-system products.
Perhaps general anti-tobacco-industry sentiment means that the FDA does not want there to be any such winners. Thus they are trying to concentrate that potential winning in a single company, which they can then crush. Juul Labs will still need to submit their products for approval in 2022, and the current attacks build a case for the FDA denying the application. That is true even if Juul can manage to change gears from acting like a freewheeling tech company and develop the capacity to submit a pharmaceutical-style approval application backed by extensive scientific research. (Therein lies another possible reason for making sure there are no winners: Pharmaceutical companies, who have more influence over the FDA than tobacco controllers, stand to profit more from cigarette prohibition if there are no good vapor products.)
Some of the preceding observations are hypotheses that are consistent with the available data but depend on extrapolations to specifics that are beyond the range of data (i.e., what might glibly and unscientifically be called “conspiracy theory”). Thus it is important to not behave like a tobacco controller and pretend particular possibilities are robustly supported conclusions; they could easily be wrong. However the evidence about the FDA being party to the campaign of attacks on Juul, and thus perhaps having instigated it, is fairly compelling.
Following the FDA announcements, one industry insider contacted The Daily Vaper and described predictions in the previous coverage as prescient. But it was really just connecting the dots, trying to explain events that simply make no sense without an underlying story. The problem is that the mainstream press, which would normally have the resources to connect the dots, are serving as transcriptionists for the FDA and its allies. This is due to a combination of seeking clickbait, a near-total lack of expertise on the tobacco beat, and FDA arm-twisting. A first step toward finding answers is noticing that there are questions.