Discussion:
Our findings demonstrate that WS-3, an odorless synthetic cooling agent, is added to several tested cool-/mint-flavored Zyn ONPs, and to Zyn-Chill, an ONP advertised as “Flavor-Ban Approved”. Extracts from the cool-/mint-flavored ONPs also contained menthol and robustly activated the cold/menthol receptor, TRPM8. Extract from Zyn-Chill, containing only WS-3, displayed higher efficacy for TRPM8 activation, exceeding the efficacy of a maximally activating menthol concentration. While extracts of cool-/mint-flavored ONPs strongly activated the sensory irritant receptor, TRPA1, Zyn-Chill extracts showed only weak efficacy and potency at TRPA1, suggesting reduced irritancy. Containing WS-3 exclusively, “Flavor-Ban Approved” Zyn-Chill likely provides a robust oral cooling sensation by strongly activating TRPM8, in combination with lower sensory irritation (i.e. weaker TRPA1 activation) than menthol would cause, thereby likely increasing the appeal of the product.
Rodent studies demonstrated that, similar to menthol, synthetic cooling agents have analgesic activity, suggesting that WS-3 may soothe the sensory irritation caused by nicotine in ONPs.10 Sensory cooling stimuli, either by cold water, a synthetic cooling agent or menthol, had strong reinforcing properties in intravenous nicotine self-administration studies in rats.11 These studies suggest that cooling sensations and analgesia induced by odorless synthetic cooling agents in ONPs (eg., Zyn-Chill) may improve the sensory experience of the user, thereby facilitating product use initiation and more frequent consumption under the guise of a “Flavor-Ban-Approved” product.
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The moniker “Flavor-Ban Approved” was likely introduced by Swedish Match to position these ONPs in markets where all flavored tobacco products have been banned, such as in the State of California.12 In regions without such bans, or bans that do not apply to ONPs, the products may appeal to consumers concerned about flavors associated with increased toxicity and addictiveness of tobacco products. In this case, “Flavor-Ban Approved” might represent misleading health messaging, as consumers might perceive these products as healthier. However, our present study demonstrates that these products are not free of additives modifying sensory product perception.
While the US Food and Drug Administration (FDA) has not announced any intent to regulate ONPs and their flavors, any such regulation will have to rely on the concept of “characterizing flavor” that is primarily based on odor perception, i.e., such as a minty, fruity, or sweet smell. Regulations in California and the other US states and municipalities banning certain flavored tobacco products also rely on this approach. The ambiguity of this approach may provide a loophole for the tobacco industry to add odorless sensory chemicals such as synthetic cooling agents that impart comparable or stronger physiological cooling and analgesic effects than menthol, and that at lower amounts per product unit. The manufacturer of Zyn products, Swedish Match / PMI, seems to be confident that synthetic cooling agents don’t fall under the category of “characterizing flavor” and are, therefore, “Flavor-Ban Approved.”3 FDA’s proposed product standard for menthol cigarettes that, if implemented, will lead to a ban of this product category, extends the definition of “characterizing flavor” by adding “multisensory experience”, including cooling sensations, as a factor to determine whether a tobacco products has a characterizing flavor.13 If approved as written, this extended definition will allow regulation of synthetic cooling agents in combustible cigarettes and, in the future, in all other tobacco products. Alternative approaches to regulate synthetic cooling agents include the use of positive lists of permitted tobacco additives in Canada and currently in preparation in the Netherlands,14,15 or Germany’s ban of chemical scaffolds present in menthol and in most synthetic cooling agents in combustible cigarettes.16
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