January 10-11, 2011: TPSAC Meeting Background Materials

DISCLAIMER: The information in these materials is not a formal dissemination of information by FDA and does not represent agency position or policy. The information is being provided to TPSAC to aid the committee in its evaluation of the issues and questions referred to the committee.

Summary of Briefing Package Contents:

1. UPDATED Table 1.1 - Table of Evidence for Peer-Reviewed Journals included in the FDA White Papers. Bibliography also included.

2. Articles included in the December 2010 supplement of ADDICTION

3. The secondary data analyses requested by the TPSAC at the March 2010 meeting

4. Submissions from Dr. Gregory Connolly
 

5. Benowitz N, Dains K, Dempsey D, Havel C, Wilson M, and Jacob,III P. Urine Menthol as a Biomarker of Mentholated Cigarette Smoking. Cancer Epidemiol Biomarkers Prev; 19(12) December 2010

6. Request for Correction, pursuant to the Information Quality Act and its Guidelines, of Information Being Disseminated by the Food and Drug Administration and its Center for Tobacco Products regarding Menthol Cigarettes and Public Health – Center for Regulatory Effectiveness
 

Briefing Package Contents:

• UPDATED Table 1.1 - Table of Evidence for Peer-Reviewed Journals included in the FDA White Papers. Bibliography also included.

• Articles included in the December 2010 supplement of ADDICTION

• The secondary data analyses requested by the TPSAC at the March, 2010 meeting

  - Index

  - “Menthol Cigarettes and Youth Smoking Uptake”

  - "Modifying Effect of Menthol on the Relationship between Time to First Cigarette after Waking and Nicotine Uptake, and Time of First Cigarette and Lung Cancer Risk.”

  - “Menthol Cigarettes, Saliva Cotinine, and Nicotine Dependence in Adolescents.”

  - “Analysis of Mentholated Cigarettes using the COMMIT Data.”

  - “A Longitudinal Study of the Association between Menthol Cigarettes and Indicators of Dependence:  Findings from the International Tobacco Control Project.”

  - “Tobacco Dependence, and Smoking Cessation.” (These projects address both dependence and cessation.)

      - Report on Project BREAK FREE

      - Report on Project CARE

      - Report on Project MOM

  - “Examining the Relationship between Menthol Smoking and Cessation using Data from the 2003 and 2006/7 Tobacco Use Supplement.”

  - “Nicotine Dependence and Intentions to Quit Among a Community Based Sample of African American Menthol and Non-Menthol Smokers in Los Angeles”.  (This study addresses both cessation and dependence.)

  - “The Influence of Menthol Use on Cessation Outcomes in a Smoking Cessation Treatment Program.”

  - “Tobacco-related Cancer Risks in Relation to Menthol Cigarettes:  A Case Control Study.”

  - “A Study of the Association Between Menthol Cigarette Smoking and Disease Risk.”

• Submissions from Dr. Gregory Connolly
  -Leffingwell - Cooler than Menthol

  -Leffingwell - Olfaction: A Review (1, 2, 3, 4, 5)

  -Documents from the Legacy database

  -Risks Associated with Smoking Cigarettes with Low Machine-Measured Yields of Tar and Nicotine. Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S. Department of
Health and Human Services, National Institutes of Health, National Cancer Institute, NIH Publication No. 02-5074, October 2001.

• Benowitz N, Dains K, Dempsey D, Havel C, Wilson M, and Jacob,III P. Urine Menthol as a Biomarker of Mentholated Cigarette Smoking. Cancer Epidemiol Biomarkers Prev; 19(12) December 2010

• Request for Correction, pursuant to the Information Quality Act and its Guidelines, of Information Being Disseminated by the Food and Drug Administration and its Center for Tobacco Products regarding Menthol Cigarettes and Public Health – Center for Regulatory Effectiveness