Menthol Report: What to Expect
Tobacco Products Scientific Advisory Committee’s Report and Recommendations on the Impact of the Use of Menthol in Cigarettes on the Public Health
The Tobacco Products Scientific Advisory Committee (TPSAC) is currently developing a report and recommendations on the impact of the use of menthol in cigarettes on the public health. The report and recommendations are due to the Secretary of the U.S. Department of Health and Human Services (HHS) by March 23, 2011. As the due date draws near, the U.S. Food and Drug Administration (FDA) looks forward to receiving the report from the Committee. FDA also understands that members of the tobacco industry, members of public health and tobacco control organizations, as well as the general public are eager to see the report and may have questions about the actions FDA will take after receiving the report. Therefore, FDA has outlined what is to come over the next few months as the Committee finalizes the report.
Upcoming Meetings – There are currently two scheduled upcoming meetings of the full TPSAC (March 2, 2011, and March 17-18, 2011).
Report Content – The menthol report is expected to consist of eight chapters*
- Chapter 1: Introduction
- Chapter 2: Approach to Evidence Gathering and Review
- Chapter 3: Physiological Effects of Menthol
- Chapter 4: Patterns of Menthol Cigarette Smoking in the U.S.
- Chapter 5: Marketing, Initiation, Addiction, and Cessation
- Chapter 6: Effects of Menthol on Disease Risks of Smoking, Toxicology, Biomarkers, and Epidemiology
- Chapter 7: Public Health Impact of Menthol Cigarettes
- Chapter 8: Conclusions and Recommendation
In addition, FDA has asked industry representatives who serve on the Committee to develop an industry perspective document on the public health impact of menthol cigarettes that will accompany the report.
*Chapter titles have not been finalized.
Draft Chapters – The Committee intends to discuss draft report chapters at upcoming open public meetings of the TPSAC before they are finalized. Therefore, FDA will make draft copies of the chapters expected to be discussed at upcoming open public meetings of the TPSAC available to the public as part of the meeting background materials on the TPSAC Website at least two business days before scheduled meeting dates. Availability of draft chapters as background materials is contingent on the Committee’s progress. Thus, FDA cannot specify at which upcoming meetings draft chapters will be available as background materials. Draft chapters will be made publicly available at the location of the advisory committee meeting if the FDA is unable to post the background materials on its Web site prior to the meeting.
Final Report – The final report and recommendations will be submitted to the FDA from the Committee Chair on behalf of the TPSAC. The report is considered submitted to the Secretary of HHS once received by the FDA. The final report and recommendations will also be made available to the public at the FDA Center for Tobacco Products’ Website once it has been reviewed for redaction of all commercial confidential or trade secret information.
FDA Action – Once the report is received, the Secretary and FDA shall consider the report and recommendations of the Committee, as well as other scientific evidence concerning menthol cigarettes and make a determination about what action(s), if any, are warranted. There is no required deadline or timeline for the FDA to act on the recommendations provided by the Committee in the report. Any action(s) taken by the FDA that lead to sale/distribution restrictions or establishment of product standards requires rule making that includes public notice and comment. Therefore, receipt of the report and recommendations by the FDA will not have an immediate effect on the availability of menthol cigarettes.
Caryn Cohen, M.S.
Center for Tobacco Products
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
Jeffrey Ventura, M.S., M.S.
Office of Public Affairs
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993