Section 907 (e) of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) to submit a report and recommendation to the Secretary 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 – by March 23, 2011. The report has been received by the U.S. Food and Drug Administration (FDA), and is thus considered submitted to the Secretary of HHS.

 

In addition, FDA has received an industry perspective document on the public health impact of menthol cigarettes from industry representatives who serve on the TPSAC.

FDA Action – The report submitted by TPSAC will undergo a thorough review by experts within the FDA Center for Tobacco Products.  The FDA will consider the report and recommendations of the Committee, the industry perspective document, and continue to review all of the available science concerning menthol cigarettes.  The FDA will then make a determination about what future regulatory action(s), if any, are warranted. 

The Tobacco Control Act does not set a required deadline or timeline for the FDA to act on the recommendations provided by the Committee in the report. 

The Committee’s recommendation of “removal of menthol cigarettes from the marketplace would benefit public health in the United States” is simply that – a recommendation of the Committee based on their review of the current, prevailing science on the topic of menthol as an ingredient in cigarettes.  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.  Therefore, FDA’s receipt of the final report and recommendations does not have a direct and immediate effect on the availability of menthol products in the marketplace.

 

Expected Update – 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. FDA intends to provide its first progress report on the review of the science in approximately 90 calendar days from the TPSAC report due date.