FDA Menthol Independent Review Continues

Center for Tobacco Products conducting "extensive preliminary analysis" before peer review

Linda Abu-Shalback Zid, Senior Editor

WASHINGTON -- The Food & Drug Administration (FDA) Center for Tobacco Products (CTP) has released its much-anticipated "Menthol Update"--although it provides little insight into CTP's current thinking about the fate of menthol.

In March, the Tobacco Products Scientific Advisory Committee (TPSAC) deliberated on findings and recommendations regarding the public health impact of the use of menthol in cigarettes. It concluded that the "removal of menthol cigarettes from the marketplace would benefit public health in the United States." The FDA also received an industry perspective [image-nocss] document at the time.
FDA said that it would update the public on the agency's review of all available science approximately 90 days from the due date of the report.

According to the menthol update document, experts within the 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."

It further said that the CTP's "extensive preliminary analysis and evaluation" 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."

Calling the update a "nonevent" in a report, Nik Modi and Benjamin Schmid of
New York City-based UBS Securities LLC wrote that they "continue to believe the FDA will not ban menthol."

Up next for the FDA is to submit its draft independent review to an external peer review panel in July.

According to a "Peer Review Plan" on the FDA website, the review would consist of four to 10 reviewers, with primary disciplines/types of expertise including "behavioral scientist, social scientist, epidemiologist and statistician." They will be selected by a designated outside organization, and the review will take three and a half months, starting in July.

"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," according to the document.