FDA Previews War On Flavors

Carl V. Phillips | Contributor

Despite the four-year delay in its near-ban of vapor products, it has always been apparent that the U.S. FDA would continue to harass vapor product users and merchants. In particular it was clear that limiting flavor options would be part of their strategy. The Office of Information and Regulatory Affairs, the executive office that reviews proposed regulations, has posted an abstract of the FDA’s first move in this direction.

The FDA has submitted an “Advanced Notice of Proposed Rulemaking” about flavors to OIRA. Vapors may be unfamiliar with the ANPRM process, since the FDA has just skipped that step in their previous vapor product rules. Typically it consists of publishing a document that falls somewhere between a statement of policy aims and a rough draft of an actual regulation, often to seek comments. Normally the next step is to review the comments and consider the interests of the stakeholders in crafting the rule, or perhaps abandoning it. In the case of FDA tobacco policy, the next step is to ignore stakeholder comments, looking only at non-stakeholder comments that offer further rationalizations for the policy, before promulgating a final rule that best suits their political agenda.

The abstract speaks generically about “tobacco products” but it is clearly aimed at vapor products and smokeless tobacco (characterizing flavors other than menthol are already banned for cigarettes). The lead sentence telegraphs what the FDA plans to do and the rationalization they plan to offer: “Evidence shows that flavored tobacco products, especially those that are sweet or are described with terms attractive to kids, appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products.” The unqualified assertion there contrasts with the next sentence which concedes only that flavors “may play a role” in helping smokers quit.

In reality, we know that people of all ages like a variety of flavors in their food, drink and vapor products. There are inevitably some differences across different demographics, but nothing remotely as stark as implied in the abstract, that “[c]ertain flavors are generally recognized as appealing to youth….” This again contrasts with the vague statement that precedes it, about “taking into account the potential role that some flavors may play in helping some users transition away from combusted products.”

The abstract never actually states that adult preferences, or at least the preferences of would-be product switchers, will influence policy decision. (The full ANPRM might, but it seems quite likely it will not.) Moreover, the last sentence says that the FDA is requesting information only on “how best to regulate flavors in tobacco products to limit appeal to youth and prevent youth initiation and use of tobacco products,” not on the value of those flavors to adults. This is in keeping with the stated title of the ANPRM, which seems better suited to a parody than real government policy: “Kid-Appealing Flavors in Tobacco Products; Request for Informaiton [sic]”.

The FDA’s lack of interest in consumer preferences is unsurprising, given that their tobacco policies have literally never included efforts to benefit consumers. Unlike real regulation, these policies are merely creeping prohibition that is intended to inconvenience, impose costs upon, and otherwise harm both consumers and producers. Harming adults who choose to use tobacco products is not an unintended consequence of “protecting” youth, but a goal in itself. Even the spin designed to suggest otherwise comes across as halfhearted.

The delay in the near-ban of vapor products – pushing the requirement that all products get nearly impossible “new product” approvals from 2018 to 2022 – is widely seen as saving the future of vaping in the U.S. But it also can be seen as saving anti-vaping efforts. The tobacco control playbook has always consisted of pursuing incremental prohibition or punishment, and only after their propaganda has laid the groundwork that it is an obviously-reasonable and minor step. With this tactic, they move toward prohibition while avoiding concerted pushback and embarrassing setbacks that would demonstrate that their policies can be reversed.

Flavor restrictions are a perfect example of this. By contrast, the near-ban would have led to widespread protests and quite possibly a reversal. It still might in 2022, but that is much less likely if severe restrictions on vapor products are already in place. In that case, the handful of major-manufacturer products that secure approval may only be marginally lower in quality than the other still-legal products.

Clive Bates, who is among the longest-standing advocates of tobacco harm reduction, mused about the abstract that the FDA “fundamentally does not understand vaping.” Indeed, it will be interesting to watch for FDA statements that imply they think some flavors – those that try to imitate tobacco smoke – are somehow any less a crafted and created flavor. More subtly, it will be interesting to watch them trying to create legal categories of flavors, which are subjective perceptions. They were able to fairly cleanly ban characterizing flavors in cigarettes because there is such a thing as (basically) unflavored cigarettes – and this could work with smokeless tobacco also – but they seem to literally not understand that vapor products do not work that way.

We can also watch for absurd conflation of “someone likes a particular flavor best” with “he would not vape if that flavor did not exist.” Obviously these are not the same, but those who write about “kid-appealing flavors” seem to genuinely not understand that. Consider: for almost every vaper, there is some hypothetical flavor that he would like even better than his favorite among what exists, and yet he still vapes without it.

The abstract also suggests that the FDA is failing to recognize the difference between flavor descriptors (e.g., “cotton candy”) and actual flavors (e.g., chemicals that, regardless of words, cause someone to think “this tastes like cotton candy”). Even with flavor descriptors, the FDA faces a game of whack-a-mole, banning “cotton candy,” only to have to act again to ban “kotton kandy.” A vague general ban of “kid friendly” or even “sweet” flavor descriptors would probably not survive a legal challenge.

But flavors themselves are even more elusive. A manufacturer could sell the same flavor as their current “cotton candy” and just call it “pink.” After all, people still refers to the cigarettes in the gold box as “Marlboro Lights” despite the ban on the “lights” descriptor. Of course, the FDA might take advantage of their Kafkaesque regulatory approach and declare a name change to constitute a banned “new” product. In that case, they might be forced to defend the tenuous claim that a particular flavor profile – something that is basically impossible to legally define – is “kid friendly” regardless of its name.

However this plays out, it will be bad for vapors. That is the goal. Even if the FDA suffers some setbacks due to their lack of understanding – and it seems likely they will – the new rule will creep further toward prohibition and impose costs on producers that will ultimately be paid by consumers.

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Carl V. Phillips

Contributor

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