Evaluating the potential impact of a menthol ban in cigarettes and e-cigarettes among current menthol smokers

PROJECT SUMMARY/ABSTRACT
The US FDA has the authority to regulate the manufacture, marketing, and distribution of tobacco products.
Although the Tobacco Control Act banned the sale of cigarettes with characterizing flavors, menthol cigarettes
are currently exempt from this ban, and menthol cigarette use remains a serious public health problem. Use of
menthol cigarettes is associated with greater nicotine dependence and lower rates of quitting smoking, and rates
of menthol cigarette use are highest nationally among Black people, contributing to tobacco-related health
disparities. Evidence suggests that banning menthol flavor in cigarettes would benefit public health. However,
menthol flavor is also available in other tobacco products, such as e-cigarettes, which are the most commonly
used non-cigarette tobacco product among adults. When considering flavor restrictions on tobacco products to
protect public health, the FDA could decide to ban menthol in cigarettes, e-cigarettes, or both products. Research
is needed to understand how availability of menthol (vs. tobacco) flavored e-cigarettes would impact cigarette
use following a ban of menthol cigarettes. The current project will use an established paradigm to model the
impact of these menthol regulatory scenarios on real world smoking behavior. We will recruit 150 adults who
currently smoke menthol cigarettes and will randomize them to 1 of 3 conditions modeling different regulatory
scenarios. We will recruit equal numbers of participants who identify as Black vs. non-Black and will stratify
randomization by race. Participants will be provided with cigarette and e-cigarette products to use for 8 weeks
based on their assigned condition: 1) no menthol ban (menthol cigarette and menthol flavored e-cigarette), 2)
menthol ban in cigarettes only (non-menthol cigarette and menthol flavored e-cigarette), 3) menthol ban in both
cigarettes and e-cigarettes (non-menthol cigarette and tobacco flavored e-cigarette). A follow-up survey at week
12 will assess tobacco use outcomes once the study products are no longer provided. The study aims are to 1)
examine the impact of banning menthol flavor in cigarettes and e-cigarettes on smoking behavior and 2)
investigate whether outcomes differ by race to understand the impact of menthol ban policies on Black (vs. non-
Black) individuals given high rates of menthol cigarette use in this population. The primary outcome will evaluate
changes in the number of cigarettes smoked per day and will examine differences by regulatory scenario. We
will use mixed model analyses to evaluate changes in smoking behavior, regulatory scenario will be a between-
subject factor, and time will be a within-subject factor. Secondary outcomes will compare percent days smoke-
free, changes in nicotine dependence, and motivation, confidence, and intentions to quit smoking by the
regulatory scenarios. We will examine whether changes in the outcomes differ by Black vs. non-Black
participants to compare the magnitude of the effect of the various menthol ban scenarios by race. Results will
contribute critical information to inform regulatory policies regarding menthol in cigarettes and e-cigarettes in
order to maximally reduce the use of combustible cigarettes and promote health equity.

Grant Number: 5R01DA054993-04
NIH Institute/Center: NIH
Principal Investigator: Krysten Bold