90 Day Update on FDA’s Review of All the Available Science.
The Family Smoking Prevention and Tobacco Control Act requires the U.S. Food and Drug Administration’s (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 regarding the public health impact of the use of menthol in cigarettes. In addition, FDA has received an industry perspective document on the public health impact of the use of menthol in cigarettes from industry representatives who serve on the TPSAC.
On March 18, FDA stated it would update the public on the agency’s review of all the available science in approximately 90 days.
Experts within the FDA Center for Tobacco Products (CTP) are 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 preliminary analysis and evaluation of the available science relating to public health impact of the use of menthol in cigarettes includes 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 will submit 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. After peer review, the agency will make the results of the peer review and the preliminary scientific assessment available for public comment in the Federal Register.