The FDA has published their advance notice of proposed rulemaking (ANPRM) regarding regulating (i.e., banning) flavors in tobacco products. The primary purpose appears to be banning flavors in e-liquid, under the guise of “protecting children,” though the FDA is also revisiting banning menthol cigarettes, which they previously rejected. Other products could also be swept up in this prohibition effort. This move has long been anticipated and comes at a time when it is not actually the worst of this month’s FDA ANPRMs for vapers: The ANPRM for their pet project, removing the nicotine from cigarettes, includes dire threats to vaping including possibly banning refill e-liquid. Banning some or all of the flavors options for vapor products will inflict substantial harm on consumers, but the prohibition can and will be circumvented by experienced vapers.
In theory the ANPRM stage of regulation is supposed to be a time to gather information on the wisdom of a proposed policy, with the possibility of abandoning it if it is discovered to be a bad plan. But that would only be true if the FDA were acting as a legitimate regulator, working in the best interests of the public. A careful reader of the ANPRM will notice that the fix is in before even finishing the abstract:
…this ANPRM is seeking comments, data, research results, or other information about, among other things, how flavors attract youth to initiate tobacco product use and about whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products. (emphasis added)
The FDA is not asking whether there is any evidence that flavors — all of them, apparently — cause more “youth” to initiate tobacco product use. There is no such evidence, but since they are also not asking for comments on whether there is, it is apparently out-of-bounds to tell them that. Meanwhile, the FDA questions whether certain flavors (obviously referring to vapor products) help adults not smoke, even though there is overwhelming evidence that they do.
Anyone who follows FDA Commissioner Scott Gottlieb on Twitter, however, does not even need to be a careful reader to learn that the FDA is violating proper process and overreaching their legitimacy:
Today @US_FDA took a critical step in efforts to reduce tobacco use, especially among youth, by issuing an advance notice of proposed rulemaking to explore regulatory options to address the role of flavors ‒ including menthol ‒ in tobacco products: https://t.co/PdUZ5pDcYi
— Scott Gottlieb, M.D. (@SGottliebFDA) March 20, 2018
An ANPRM is only a “critical step” if it is merely a pro forma step before going ahead with a preordained plan. Gottlieb is making clear that the FDA has already decided upon their answer to the questions asked in the ANPRM and is moving toward acting. They will “address the role of flavors” with some “regulatory options.” Indeed, they have probably already decided which ones.
None of the evidence that is deployed to claim that particular flavors cause nonsmokers to try vaping does any such thing. We can collect evidence about what flavors someone likes best, but preference does not equal causation. Every individual is going to have a favorite (by definition), and there will be common themes. Listing what those are tells us nothing about their effects. If your favorite pizza place had never existed, would that have prevented you from ever eating pizza? Obviously not, but that is equivalent to the absurd assumption behind the flavor claims.
However, when the FDA looks at the evidence about whether flavors reduce adult smoking, you can be sure they are going to “rediscover” how to be skeptical of evidence. In particular they are going to demand proof that many vapers would not have quit smoking, or would have returned to smoking, were it not for flavor options. There actually is very compelling evidence, in the form of thousands of testimonials that say exactly that. This self-insight and self-reporting is the only conceivable source of such evidence, but we can expect it will be ignored based on that mantra of people who do not understand science, “those are just anecdotes.” By dismissing the only possible source of evidence, the FDA has predetermined the answer.
It is all reminiscent of the cliche about tinpot dictators who declare, “we believe in the rule of law and are not going to just shoot him; we will give him a fair trial, and after we find him guilty we will execute him.”
For the most part, banning flavors will be simply a nuisance to experienced vapers, unlike some other looming rules, because most will simply start flavoring their e-liquid themselves. Countless recipes and easy options for ordering flavoring ingredients will be available. As if to emphasize just how poorly the FDA understands vaping, the ANPRM asks “what evidence is there, if any, that consumers would start to flavor their own tobacco products?” Trying to ban flavor categories is akin to banning the use of particular spices in soup: you will no longer be able to order it in (most) restaurants, but you can always make it at home. Teenagers are also going to figure out do-it-yourself flavoring; they are natural hackers, after all, and they have the time to work on it.
The greater harm will be to those smokers who might have quit if they could have easily gotten the better flavor options. Of course, the experienced vapers who are encouraging them to switch (a common story) could always hook them up.
Some elements of the industry will be devastated. Minimally-flavored e-liquid, suitable for DIY flavoring, will be a commodity with very low margins. Closed systems, stuck with limited flavors, will become much less competitive. Some e-liquid manufacturers will make the transition to selling flavor concentrates, but they will find themselves competing with homebrew.
As previously reported, the ANPRM for low-nicotine cigarettes indicated an interest in banning products that could be used to add the nicotine back (which basically means e-liquid). By contrast, there is no suggestion of trying to ban the sale of flavoring agents in the new ANPRM. Indeed, as has been pointed out to the FDA from the time they first proposed the deeming regulation, they cannot stop this. Apparently they have realized they lack the jurisdiction to ban e-liquid flavoring concentrates, let alone recipe ingredients.
Presumably the FDA mostly sees this as groundwork for 2022 (the deadline to apply for “new product” approval for all vaping products) and an easy way to placate the extremists who are demanding some action. A flavor ban will make life easier for the FDA, limiting the 2022 applications to closed-systems with only the allowed flavors. Open system products never had any real chance of being approved. By damaging the industry, the flavor ban will dramatically reduce the energy available to push back against the resulting blanket ban.
But in some ways a flavor ban could be beneficial to vapers despite it being intended to hurt them. The infrastructure created to supply DIY flavoring agents and commodity flavorable e-liquid is exactly what will be needed to supply the black market should prohibition happen as scheduled.