Will FDA Ban All Non-Tobacco Vapor Flavors?

Carl V. Phillips | Contributor

The FDA intends to soon launch its war on vapor product flavors. As recently reported, the FDA has filed a notice that makes clear their intention to limit flavor options. The previous article noted that the publicly available abstract and even the title are thick with anti-flavor rhetoric, referring to “Kid-Appealing Flavors.”

That abstract contrasts with parallel FDA filings about possible regulations of nicotine levels, e-cigarette batteries, manufacturing quality control and filing requirements, which are all matter-of-fact and professional in tone. The other filings seem to be genuinely seeking useful information, and they acknowledge that the details of any regulation and possible implementation are uncertain. The flavor filing seems to describe a fait accompli that is based on the most extreme “think of the children!” rhetoric.

As noted in the previous article, trying to regulate flavor descriptors – let alone flavors themselves – is a bit of a legal minefield. Patricia I. Kovacevic, one of the country’s most experienced tobacco industry attorneys and a leading expert on regulatory affairs, is the General Counsel and Chief Compliance Officer for Nicopure Labs, a leading US-based manufacturer and worldwide distributor of premium vaping products. She observes that the US is one of the few countries where government rules can, occasionally, be reversed through litigation. However, there are methods the FDA could use to successfully limit flavor options.

Because flavor perceptions are subjective, it is not possible to simply ban all e-liquid that tastes like cotton candy or bubblegum. But according to Kovacevic, the FDA could ban or cap levels of particular flavoring chemicals, regardless of how these flavors are described or the products are labeled (this is covered by FDA’s rulemaking authority under Section 907 of the Tobacco Control Act). Alternatively, she observes, FDA could choose to ban all flavors other than tobacco and menthol. FDA has obvious political cover for this since it parallels the established and little-resisted rules for cigarettes.

The latter option is far easier. The FDA lacks the scientific capacity, expertise and wisdom to determine the right maximum quantity to set for a chemical to best serve a particular goal. More precisely, they lack the ability to determine the right quantity to reach a goal of, say, making the product unappealing (by some measure) to 90 percent of minors. If, however, the goal is to just harm product users and producers – as is clearly the FDA’s goal in most of their tobacco “regulation” – then no such science is needed; they merely need to choose a number that is lower than what is commonly used. But assuming that is the goal (and given that they are not capable of pursuing any other goal, it is hard to imagine it is not), they might as well save themselves a lot of effort and jump straight to banning all but tobacco and menthol flavors.

Kovacevic believes that this would probably also be easier to defend against legal challenges. To defend a limit on the quantity of a chemical that imparts, say, grape-like flavor, the FDA would have to present specific evidence about that flavor. This would have to be repeated for every chemical. By contrast, for the blanket ban, “FDA would likely rely only on aggregate data of underage use and preference of ‘flavors’ in general and would not have to be too granular with respect to individual flavor preferences, for which it may not have enough data.”

Though the quality of the research on flavors in tobacco products ranges from highly questionable to obvious junk, it seems very unlikely that a court (let alone a legislature) would acquire enough scientific wisdom to dismiss it as they should. Thus the FDA might be reversed based on a lack of specific evidence (or “evidence”) about grape flavor, but it is not so likely they will be reversed based on the fact that none of the evidence about flavors genuinely shows what tobacco controllers claim.

The broad restriction would have a wide grey area around it. A “tobacco-flavored” e-liquid could probably get fairly grape-y before the FDA could justify banning it as not “really” being tobacco-flavored. But it would be very difficult to get away with a full-on grape flavor, even if it were called tobacco flavor.

Such flavor descriptors are also a possible target for an FDA ban (e.g., banning calling a flavor “cotton candy,” whatever the actual taste). The sketchy research that provides “evidence” about minors’ flavor preferences is actually mostly about flavor descriptors, rather than actual flavors. Kovacevic explains that the FDA could ban descriptors based on its regulatory authority over labeling, advertising and promotion (granted under Section 906 of the Tobacco Control Act). She notes this could be challenged on free-speech grounds as well as the procedural grounds that could be used to challenge a Section 907 ban. However, given the reasons to suspect the FDA’s goal is to ban most flavors, this seems unlikely to be where any major battles will be fought. If the FDA allows only two flavors, the flavor descriptor bans will happen en passant.

The FDA abstract pointedly asks for more information about how “to limit appeal to youth” but not about the role flavors play in making vapor products more appealing to legal consumers, including helping them to not smoke. But Kovacevic notes that any rule made under Section 907 of the TCA requires the FDA consider “information concerning the countervailing effects of the product standard” which would include impacts on the health of adult tobacco users and the creation of black markets.

It is those effects that make the predicted move by the FDA harmful not just for consumer welfare but also for (real) public health. Kovacevic offers a reminder that the variety of enjoyable vapor product flavors make it more attractive for adult smokers become or stay ex-smokers, and for some of them it is the difference between continuing to smoke or not. She adds that it is illegal to sell vaping products to minors.

Therefore, the whole premise of ensuring vaping products d0 not appeal to young people is a flawed one:

“The so-called balancing act – between ensuring that vaping products are not appealing to minors and enabling adult vapers to switch away from combustibles with flavor choices – is a false dilemma. There is no dilemma. If a product is illegal for a certain category of potential users, isn’t it more important and impactful to focus on enforcement against illegal sales to minors than to punish smokers who need all the help they can get to quit smoking, by taking away palatable choices of alternative products?”

FDA and others express great concern about minors using vapor products. If that is their concern, there are enforcement remedies that do not include trying to ruin the quality of the products (and thereby create a black market that might well increase minors’ access). If there were a magic alteration that made the products much less appealing to minors and only slightly less appealing to adults, that might be defensible. Calling a specific list of flavors “kid-friendly” is an attempt to claim there is such a magic formula. But even if that were valid, it seems likely that FDA will not bother to try to thread that needle, but will instead jump straight to making the products far less appealing to everyone.

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Carl V. Phillips



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