I. Executive Summary
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 withrestrictions on allowable doses and use. There are no product standards for menthol when used incigarettes.Approximately one-fourth of all cigarettes sold in the United States are menthol (Giovino, 2004).The vast majority (88%) of adult smokers in the United States start to smoke before age 18 (U.S.Department of Health and Human Services, 2012). Thus, youth and young adulthood appear to be a critical age-span for initiation of cigarette smoking, and research suggests that mentholcigarettes may have an impact on initiation rates that differ from nonmenthol cigarettes. Further,the impact of menthol cigarettes on dependence, cessation, and health risks has been the topic of scientific inquiry and intense debate.The Federal Food, Drug, and Cosmetic Act (FD&C Act) (Section 907 (e)) requires FDA’sTobacco Products Scientific Advisory Committee (TPSAC) to submit a report andrecommendation to the Secretary of Health and Human Services (HHS) on the impact of the useof menthol in cigarettes on public health – including use among children,
African Americans,Hispanics, and other racial or ethnic minorities – by March 23, 2011. In March 2010, TPSAC began its process of reviewing the available evidence as well as soliciting and receiving valuableinput from researchers, tobacco industry representatives, consultants to the tobacco industry,representatives of the public health sector, and others. On July 21, 2011, TPSAC voted on itsfinal report and recommendations on menthol, which concluded “removal of menthol cigarettesfrom the marketplace would benefit public health in the United States.” TPSAC noted that avariety of options were available for FDA to consider, and they made no specific suggestions for follow-up by FDA should the agency decide it should pursue this recommendation. In addition,the non-voting industry representatives of TPSAC submitted a separate document reflecting theindustry perspective. That document acknowledged the inherent risks of all tobacco products,including those that have menthol as a characterizing flavor, and raised the possibility of countervailing effects, including potential risks of contraband menthol products, should a ban beimposed.Independently, FDA has undertaken a thorough review of the available science concerningmenthol cigarettes. To accomplish this task, FDA weighed the collective body of evidence for theimpact of the use of menthol in cigarettes on public health. One of the first considerations inweighing the value of a particular study was the relevance of the information to the consumptionof menthol cigarettes in the United States. Findings that were replicated in different studies,especially different types of studies, were given greater weight. FDA also considered the
of information, the type of study, and the quality of study methods and data. In drawing conclusions,more consideration was given to peer-reviewed studies, studies in humans, and studies that wereappropriately powered and designed. In this process, FDA evaluated the peer- reviewedliterature, industry submissions and other materials provided to TPSAC, and performed or commissioned additional analyses in an attempt to fill in and inform some of the gaps in theliterature.