April 21, 2010

On March 30 and 31, the FDA Tobacco Products Scientific Advisory Committee (TPSAC) met for the first time.*  The committee’s first charge is to prepare a report and recommendation to the Secretary of Health and Human Services on the impact on public health of the use of menthol in cigarettes.  In particular, the committee must consider the effect of banning menthol in cigarettes on cigarette consumption, initiation, market for contraband, as well as the effect on children, African Americans, Hispanics, and other racial and ethnic minorities.

The Family Smoking Prevention and Tobacco Control Act banned the use of most flavorings in tobacco products, with the major exception of menthol.  Instead, the legislation called for the study by the TPSAC, to be followed by possible regulatory action by the Secretary. 

To provide background for their work, on the first day the committee heard presentations based on published studies covering the demographics of menthol cigarette users, menthol cigarettes and smoking initiation, marketing of menthol, effect on nicotine dependence, smoking cessation behavior, and health effects.  No clear picture emerged on the effect of menthol in cigarettes inducing people to smoke and making it harder for them to quit.

The committee heard that 19.2 million smokers use menthol cigarettes.  Almost half of adult menthol cigarette smokers come from minority groups, including 80% of African Americans smokers.  Adolescent smokers are more likely to smoke menthol than adults.  Almost half of adolescent cigarette smokers smoked menthol, compared to less than one third of adults. 

Menthol cigarettes are more widely used by beginner youth smokers than by established youth smokers.  The limited data do not show menthol associated with an earlier age of smoking initiation.  There is limited data on whether early use of menthol is associated with subsequent nicotine dependence.

Menthol smokers generally had their first cigarette of the day earlier than others. This is used as an indicator of nicotine dependence, with the shorter the time to the first cigarette upon waking, the more dependent the smoker is. Teen menthol smokers had 45% greater odds of scoring higher on nicotine dependence scale for adolescents.

Studies provided no clear answers on the association between adult menthol use and cessation, although the outcomes for successful quitting appear to be worse for adult Black and Hispanic menthol smokers and inconclusive for White smokers.

Marketing campaigns and consumer perception seemed to indicate a connection between menthol and healthier, less harsh products. 

After hearing from the public, including several tobacco industry speakers, much of the second day was spent on deciding what information to seek from the tobacco industry (from non-public sources).  Topics included menthol content by cigarette brand; qualitative description and industry understanding of the use of menthol; clinical effects of menthol; marketing data, including consumer perceptions of menthol’s effects and details on any marketing campaigns aimed at particular groups; biomarkers; and population effects.  Another question raised by members of the committee dealt with the international experience of menthol, where the ingredient may not be as widely used as in the U.S.  There was also some discussion about whether manufacturers should be asked to justify the use of menthol, just as drug manufacturers are asked to justify their ingredients.

The next committee meeting, likely in the summer, will be devoted to the industry response to these requests. 

* See March newsletter for list of committee members.