FDA announcement of threat to remove major e-cigarette brands from the market coincides with sharp rise in Big Tobacco share prices. pic.twitter.com/kjLxEuU4Qj — Christopher Russell (@NicotineSurveys) September 12, 2018

Gottlieb says that the vapor industry isn’t doing enough to stem the tide of youth vaping. He claims that preliminary, unpublished data suggest that teenage use of vapor products has exploded in the last year. The data, of course, are secret. You’ve got to trust the commissioner on this one. The culprit may be flavors, he thinks. The agency is already in the process of issuing rules on e-liquid flavors, but Gottlieb seems to indicate drastic action may be called for. A flavor ban isn’t unexpected. After all, the FDA already tried to ban flavors in 2016. But asking vapor companies to choose between voluntarily shutting down sales of their most popular products or facing an FDA ban is akin to offering the choice of suicide or murder. “One factor we’re closely evaluating is the availability of characterizing flavors,” he said in an official statement. “We know that the flavors play an important role in driving the youth appeal. And in view of the trends underway, we may take steps to curtail the marketing and selling of flavored products. We’re now actively evaluating how we’d implement such a policy.” Gottlieb explains that he postponed the final deadline for manufacturers to submit premarket tobacco applications (PMTA’s) for existing products from 2018 to 2022 in order to create workable standards for the industry to follow. “But in view of the accelerating use among youth,” he says in his official statement, “we’re actively considering whether we will enforce the premarket review provision earlier, when it is apparent that these products are now subject to widespread youth use.” “Thousands of small-business vape shops across America do not engage in irresponsible marketing practices and do not even sell the products being targeted by the FDA with threatening letters,” responded American Vaping Association president Gregory Conley. “Despite this, Commissioner Gottlieb is threatening to shut down all these businesses unless larger manufacturers unilaterally choose to change their marketing practices. It is absolutely absurd and a perversion of how regulatory agencies are supposed to approach their work.”

@FDATobacco has lost its mind and gone all in against vaping. Similar letters not issued about sale of cigarettes and youth smoking. https://t.co/E0PBCdN2fb — Clive Bates (@Clive_Bates) September 12, 2018

Of course, the FDA never intended to offer detailed guidance to manufacturers. If Gottlieb hadn’t shown up and extended the deadline, the vaping industry would already be as dead as a doornail. But now he’s feeling the pressure from tobacco control groups and the politicians they influence. So the PMTA extension and flavors are on the table — because we’re in the midst of an epidemic. The word “epidemic” is liberally strewn throughout both Gottlieb’s official statement and the FDA press release. “I use the word epidemic with great care,” says Gottlieb. “E-cigs have become an almost ubiquitous ‒ and dangerous ‒ trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable. I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.”

Youth use of e-cigarettes has declined in the last two years, corresponding with historic lows for tobacco product use. To suggest that there is an "epidemic" suggests that political hacks are running this operation, not professionals guided by evidence. — Paul Blair (@gopaulblair) September 12, 2018

That’s the most disturbing part of Gottlieb’s new war on vaping. The suggestion that attractive alternatives for smokers could be prohibited because there is no way to prevent adolescents from wanting to use them. And the idea that preventing youth from wanting to try adult products is even possible flies in the face of all human knowledge about the teenage brain. The entire period of adolescence is a rehearsal for adulthood: teens practice being adults by experimenting, trying adult things, and making adult decisions. Sure, parents try to guide and protect them, but you can’t bypass the period between childhood and adulthood. Gottlieb’s willingness to trade the lives of adult smokers for the illusion of teenage purity is simply delusional. Can you think of another adult product that is prohibited because it also appeals to adventurous teenagers? If you do, let the FDA know, so they can label it tobacco and ban it. Of course, there’s no threat to ban cigarettes. Cigarettes have never had to go through premarket review or prove to the FDA’s satisfaction that they protect the public health. “If underage consumption does not justify a ban on tobacco cigarettes (and I don’t think it does), it cannot possibly justify a ban on competing products that are much safer,” wrote Jacob Sullum today in Reason.

Follow the money. Cigarette company stocks gained over $20 billion in value today after the FDA's recent announcement that it is considering a much more aggressive approach to e-cigarettes: pic.twitter.com/YtSiNYuj4e — Charles A. Gardner, PhD (@ChaunceyGardner) September 12, 2018

Commissioner Gottlieb apparently thought that wholesale disruption of the cigarette market would happen neatly, with each smoker waiting in line to exchange their Marlboros for a drab, flavorless vape that teenagers would ignore, and then all the anti-tobacco activists that depend on cigarette sales would cheer him as he walked off into the sunset. But that’s not how disruption of a powerful market happens. And that’s not how teenagers behave. And that’s not what entrenched industries like tobacco control do when threatened with irrelevance. You might hope the world works that way, but it doesn’t. “We need a regulatory process that requires product applications to show that the marketing of the product is appropriate for the protection of the health of the overall population,” says the commissioner. “And we need a regulatory process that keeps these same electronic cigarette products out of the hands of youth.” Gottlieb thinks he can control market forces and steer human behavior in the direction he prefers. But that’s not how regulation works. Nothing is simple. The best he can expect now is that the unintended consequences of his new actions will be more acceptable to those he desperately wants to please than what he did before. He’s regulating based on hope. And hope isn’t much of a plan.