The Volokh Conspiracy
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Another Study on Flavored Vaping Products the FDA Can Ignore
Evidence continues to accumulate that non-tobacco-flavored vaping products can help reduce or discourage smoking.
The Food and Drug Administration has been particularly resistant to approving the sale of vaping products that are not flavored like cigarettes. The vast majority of the vaping products approved to date have been tobacco flavored. A small handful, approved more recently, have been menthol flavored. The thousands of marketing applications for products with other flavors have been denied. Thus, there are no FDA-permitted vaping products on the market that provide consumers with a flavor different from that provided by cigarettes.
There is a growing body of evidence that restrictions on non-tobacco-flavored vaping products can increase smoking rates, including among youth. There is also growing evidence that non-tobacco-flavored vaping products may help smokers cut back on cigarette consumption or quit. Yet the FDA has shown little interest in this research, maintaining what appears to be a de facto ban on alternative vaping flavors.
A new peer-reviewed study in Addictive Behaviors provides additional evidence of that the availability of alternative flavors can help smokers reduce or cease their cigarette consumption. In this study, smokers were given vaping products with a choice of flavors with the aim of identifying "the impact of e-cigarette flavoring choice on e-cigarette uptake and changes in cigarette smoking." And what did it find?
Compared to participants who exclusively received the tobacco flavor, participants who received any other flavor combination had greater e-cigarette uptake at the end of product provision (74 % vs. 55 %), were more likely to reduce cigarette smoking by at least 50 % at the end of product provision (34 % vs. 14 %) and at the final 6-month follow up (29 % vs. 5 %), and numerically, but not statistically, more likely to be abstinent from cigarettes at the end of product provision (11 % vs. 5 %) and the final 6-month follow-up (14 % vs. 5 %).
From the paper:
Although only a small percentage of participants exclusively selected tobacco flavored e-cigarettes, the convergence of findings across multiple outcomes in this study suggest that non-tobacco flavors may be more appealing than tobacco flavors, and may better promote uptake and reduce cigarette smoking among adults who smoke. The FDA is currently issuing PMTA [premarket tobacco product application] decisions for individual e-cigarette products, and thus far, these decisions have included many MDOs [marketing denial orders] for non-tobacco flavors based on a lack of evidence that these flavors provide a benefit to adult smokers above and beyond the benefit provided by tobacco flavors. The data presented in this secondary analysis suggest that non-tobacco flavors may indeed provide a benefit to adults beyond the benefit provided by tobacco flavors, insofar as non-tobacco flavors better promote switching away from combustible cigarettes.
While this study is limited, it provides yet more evidence that the FDA's myopic approach to vaping product flavors may be undermining efforts to further reduce smoking and its associated public health consequences. It is also further evidence that the FDA's current approach to evaluating vaping product applications, and requiring those seeking approval of non-tobacco-flavored products to demonstrate that such products provide added benefits to public health as compared to tobacco-flavored products, is quite arbitrary. (And that this approach has been adopted without any sort of notice-and-comment process in which the FDA would have to defend this policy choice is just icing on the cake.)
