FDA Updates Menthol Report Changes

CSP Daily News


As deadline approaches, FDA explains “proposed changes” to TPSAC report

By Linda Abu-Shalback Zid

ROCKVILLE, Md. — As the deadline approaches for the Food & Drug Administration (FDA) Center for Tobacco Products to provide a menthol review status, questions have arisen about “proposed changes” to the Tobacco Products Scientific Advisory Committee’s (TPSAC) menthol report.

According to a Federal Register notice, at an upcoming meeting on July 21, “The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee.”

The menthol report, issued in March, had concluded that the “removal of menthol cigarettes from the marketplace would benefit public health in the United States.”

Kara Henschel, spokesperson for the FDA, told CSP Daily News companion publication Tobacco E-News that the changes do not affect either the conclusion or the recommendation of the report.

“There were editorial changes proposed to the TPSAC Menthol Report submitted between the March 18, 2011, meeting and March 23, 2011. The conclusions have not changed,” she said.

As for what happens next, at the time of the report, Lawrence R. Deyton, director of the Center for Tobacco Products, said that the recommendation was “simply that–a committee recommendation based on its review of current, prevailing science on the topic of menthol as an ingredient in cigarettes.”

A Frequently Asked Questions document about the menthol report on the FDA’s website states that the FDA “recognizes the strong interest in this issue among all stakeholders and will continue to communicate the steps the FDA is taking as it determines what future regulatory actions, if any, are warranted.” (Click here to view the FAQ.)

Stating that the FDA will provide its first progress report 90 days from the report’s due date (placing the deadline at June 22), the document further states: “Any future action(s) taken by the FDA to regulate the sale or distribution of menthol cigarettes or establish a tobacco product standard for menthol cigarettes will require rule making that includes public notice and the opportunity for public comment.”

Leave a Reply

Please Answer: *