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Tobacco Products

A Brief Summary of FDA’s Preliminary Scientific Evaluation



Use of menthol cigarettes—and the possible impact on users beyond that of nonmenthol cigarettes—is an important and complex public health issue. As part of its mission to protect public health through a science-based regulatory approach, the FDA undertook an independent preliminary scientific evaluation on the possible public health effects of menthol cigarettes (as compared to nonmenthol cigarettes). In doing so, the FDA considered the collective body of evidence that exists on menthol cigarettes. The results are found in the “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes.”


Key Findings

The FDA’s preliminary scientific evaluation, as well as an update that includes scientific articles published since the preliminary evaluation was submitted for peer review, indicates that menthol cigarettes likely have a public health impact beyond that of nonmenthol cigarettes.

Specifically, the preliminary evaluation is organized into nine broad chapters that reflect nine outcomes. The outcome results fall into one of five categories—associated, likely associated, likely not associated, not associated, or insufficient evidence—as shown in the table below. For more specific findings related to each outcome, please see the report’s individual chapters. 

Table 1*: Association between menthol cigarettes and various outcomes that differ from those of nonmenthol cigarettes.  

OutcomeAssociatedLikely AssociatedLikely not AssociatedNot AssociatedInsufficient Evidence
Smoke Chemistry and Nonclinical Toxicology   Are not associated with increased or decreased smoke toxicity 
Physiology Are likely associated with altered physiological responses to tobacco smoke, such as a cooling effect   
Biomarkers  Are likely not associated with increased or decreased levels of biomarkers of exposure  
Patterns of UseAre associated with particular patterns of smoking, including among African Americans, young people, and women    
Marketing and Consumer Perception of RiskLike nonmenthol cigarettes, the marketing of menthol cigarettes is associated with brand preference   Given the limited data reviewed and mixed results reported, the weight of evidence is not sufficient to support a conclusion that consumer perceptions are associated with the use of menthol cigarettes
Initiation and Progression to  Regular Use Are likely associated with an increase in initiation of smoking   
Dependence Are likely associated with an increase in nicotine dependence   
Cessation Are likely associated with decreased success in quitting smoking   
Disease Risk   Are not associated with an increase in  disease risk to the user 




Consistent patterns have emerged as a result of FDA’s evaluation of the scientific evidence relevant to the impact of menthol cigarettes on public health. While the evidence shows no increased toxicity or disease risk from menthol cigarettes compared to nonmenthol cigarettes, the data suggest that menthol cigarette use is likely associated with increased smoking initiation by youth and young adults. Further, the data indicate that menthol in cigarettes is likely associated with greater addiction. Menthol smokers show greater signs of nicotine dependence and studies indicate the menthol smoking is likely associated with decreased success in quitting smoking. These findings, combined with the evidence indicating that menthol’s local numbing properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes.

*Note: the evaluation did not attempt to establish causality, meaning that it did not seek to assess whether use of menthol cigarettes caused specific health effects.  Rather, the evaluation assessed whether use of menthol cigarettes was associated with outcomes that were different from those associated with use of nonmenthol cigarettes. It also does not constitute a decision about possible regulatory actions FDA might take with respect to menthol in cigarettes.




Page Last Updated: 03/17/2015
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