Following the passage of the Family Smoking Prevention and Tobacco Control Act, the United States Food and Drug Administration (FDA) banned cigarettes flavored with fruit or candy, but specifically excluded menthol from this ban. With the FDA recently extending its authority to electronic cigarettes (i.e., e-cigarettes), the ability to enact regulations regarding the availability of flavorants (including menthol) will extend to these products as well. As there is limited information currently available on how menthol flavoring in e-cigarettes affects overall tobacco use, there is little scientific basis available upon which to formulate regulations regarding menthol flavorant in non-cigarette forms of tobacco. The proposed study will obtain preliminary information regarding how a menthol ban that either exempts or includes e-cigarettes is likely to affect overall tobacco use. In this study, menthol cigarette smokers will over a 6 week period be assigned to one of three conditions: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes; 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes; and 3) a condition in which menthol is not banned for either product (i.e., the control condition). Participants will be able to use any products that are available in their randomization group and all participants will have medicinal nicotine available should they decide to quit tobacco products entirely. Over the six week period, tobacco product use, motivation to quit, number of quit attempts, and support for a menthol ban will be assessed. Data from this pilot study will be used to plan larger studies examining how menthol flavor in e-cigarettes affects tobacco product use patterns and toxicant exposure among smokers. This work is innovative as previous studies have not evaluated the impact of regulating menthol in cigarettes while exempting e-cigarettes. It is significant in that it begins to provide a scientific base for evaluating if menthol flavoring in e-cigarettes should be regulated differently than in cigarettes.
Currently, little information is available regarding how menthol flavorant affects smoker response to e- cigarettes despite the rapidly increasing use of these products. The proposed study will obtain preliminary information regarding how a menthol ban that either exempts or includes e-cigarettes is likely to affect overall tobacco use. As future regulation of menthol flavorant is considered, such data is needed in order to determine if any regulations concerning menthol should apply uniformly across tobacco products.
