Menthol: Update on FDA’s Review of the Science
Update on FDA’s Review of the Science
In an independent review, FDA evaluated all available science related to the impact of menthol in cigarettes on public health and drafted a report. FDA submitted its report to external scientists for peer review, and the agency is revising its report based on their feedback. The agency is preparing to make its final report available for public comment in the Federal Register. In addition, FDA will post the scientists’ feedback and the agency’s response to the feedback.
The public comments received in response to FDA’s final report may provide additional evidence or emerging data. The agency will consider these comments in addition to the information it already has from the agency’s report, from the TPSAC report and public comments, and from the industry perspective document. Based on the collective evidence, FDA will consider possible actions related to the public health impact of menthol in cigarettes.
The Family Smoking Prevention and Tobacco Control Act requires the FDA Tobacco Products
Scientific Advisory Committee (TPSAC) to submit a report and recommendation to the Secretary of the U.S. Department of Health and Human Services (HHS) on the impact of the use of menthol in cigarettes on the public health – including use among children, African Americans, Hispanics, and other racial/ethnic minorities.
At its meeting in March 2011, TPSAC deliberated on findings and recommendations on the public health impact of the use of menthol in cigarettes. In addition, industry representatives who serve on TPSAC provided an industry perspective document on the public health impact of the use of menthol in cigarettes to FDA.
In June 2011, FDA updated the public on the agency’s review of the available science. FDA announced that experts within the FDA Center for Tobacco Products (CTP) were conducting an independent review of the available science related to the impact of menthol in cigarettes on public health, including peer-reviewed literature, secondary data analyses, and independent CTP analyses of relevant large data sets. CTP’s extensive analysis and evaluation of the available science relating to public health impact of the use of menthol in cigarettes included a thorough review of scientific literature and data in the areas of chemistry, toxicology, and physiology; patterns of menthol smoking; biomarkers of exposure to toxic constituents; and initiation of cigarette smoking, dependence, and cessation.
FDA submitted its draft independent review of the science related to the impact of menthol in cigarettes on public health to an external peer review panel in July 2011.