On March 18th, the FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) issued its final report and set of recommendations on the impact of the use of menthol in cigarettes on the public health.
Under the Family Smoking Prevention and Tobacco Control Act enacted into law which authorized the Food and Drug Administration to regulate cigarettes, RYO tobacco and smokeless tobacco, the TPSAC was required to address the risks and benefits of menthol cigarettes to smokers and non-smokers, the increased or decreased likelihood that existing users of tobacco products will stop using menthol cigarettes, and the increased or decreased likelihood that those who do not use tobacco products will start using such products.
The TPSAC final report and set of recommendations enumerated a number of findings and conclusions including the following:
(1) The evidence does not indicate increased disease risks in smokers of menthol cigarettes compared to non-menthol cigarettes.
(2) The availability of menthol cigarettes has led to an increase in the number of smokers and that this increase does have an adverse public health impact in the United States.
(3) The removal of menthol cigarettes from the marketplace would benefit the public health in the United States.
(4) A potential exists for contraband menthol cigarettes if the FDA chooses to implement a ban or take some other policy action that restricts the availability of menthol cigarettes and that the FDA would need to assess the potential for contraband menthol cigarettes if such action is contemplated.
Dr. Lawrence Deyton, the director of the FDA’s Center for Tobacco Products, issued a statement indicating that the TPSAC report will undergo a thorough review by experts within the FDA’s Center for Tobacco Products and that the issuance of the final report “does not have a direct or immediate effect on the availability of menthol products in the marketplace.”
Tobacco industry manufacturers and the three non-voting industry members of the FDA's Tobacco Product Scientific Advisory Committee have compiled an industry viewpoint report in response the TPSAC’s findings and recommendations on menthol cigarettes. The industry’s report was prepared by scientists with many decades of knowledge and experience in research involving tobacco, cigarettes and menthol.
The key highlights of the industry’s report includes the following conclusions:
1. The evidence is suggestive of no causal relationship between menthol cigarettes and any disproportionate impact on the public health as a whole or for any demographic group when compared to non-menthol cigarettes.
2. The scientific data demonstrates that there is no difference in disease, initiation, cessation or dependence between menthol and non-menthol cigarettes.
3. There is no scientific basis to support the regulation of menthol cigarettes any differently than non-menthol cigarettes.
4. The available scientific studies clearly demonstrate that smokers of menthol cigarettes are at no greater risk of developing chronic smoking-related diseases than are non-menthol smokers.
5. The vast majority of studies of exposure to cigarette smoke constituents and of potential harm have found no meaningful differences between menthol and non-menthol smokers.
6. The evidence is inadequate to conclude that menthol cigarettes influence higher or earlier smoking initiation by the general population or subgroups of the population.
7. The most relevant studies do not indicate that smokers of menthol cigarettes are less likely to quit that smokers of non-menthol cigarettes.
8. Menthol cigarette smokers are not any more dependent on tobacco nicotine than non-menthol smokers.
9. A ban on menthol cigarettes would result in a dramatically larger illegal cigarette market than currently exists which would lead to severe negative impacts on public health, including the exposure of smokers to more harmful contraband cigarettes, increased access of youth to cigarettes, increased criminal activity especially in urban communities, and reduced government revenue along with loss of industry jobs.
Even though the TPSAC has compiled its final set of recommendations and the industry has responded with its own report, there is no timetable or requirement that the FDA take any regulatory action on menthol in cigarettes. According to Dr. Deyton’s statement, the FDA will issue its first progress report on reviewing the TPSAC recommendations and the industry response by June 23, 2011.