Update on FDA's Review of Science Related to Menthol
Thursday, January 26, 2012
Posted by: Natalia Gromov
Update on FDA's Review of the
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 TPSAC1 report and public
comments, and from the industry
perspective2 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.