Menthol is widely used in consumer and medicinal products and has long been used in cigarettes, often as a flavor-characterizing additive. In medical products, menthol is regulated as a drug with restrictions on allowable doses and use. There are no product standards for menthol when used in cigarettes. In this report, The FDA has undertaken a thorough review of the available science concerning menthol cigarettes. To accomplish this task, FDA weighed the collective body of evidence for the impact of the use of menthol in cigarettes on public health. In reviewing the science of menthol smoking, FDA divided the scientific evidence into the following broad categories: smoke chemistry and nonclinical toxicology; physiology; biomarkers; patterns of use; marketing and consumer perception of risk; initiation and progression to regular use; dependence; cessation; and disease risk.