FDA Tells Us What We Already Knew About Menthol: No New Implications for Policy

Yesterday, the FDA released a long-awaited report summarizing the scientific evidence regarding menthol cigarettes. The report follows a similar report on menthol from the Tobacco Products Scientific Advisory Committee. The FDA is now asking for comments on the report as well as any recommendations for potential regulation. It is possible, but not definite, that the FDA could respond after the comment period by proposing a regulation.

Here are the major conclusions of the report:

1. the weight of evidence supports the conclusion that, from a nonclinical toxicity standpoint, menthol in cigarettes is not associated with increased or decreased smoke toxicity;
2. the weight of evidence supports the conclusion that menthol in cigarettes is likely associated with altered physiological responses to tobacco smoke;
3. the weight of evidence supports the conclusion that menthol in cigarettes is likely not associated with increased or decreased levels of biomarkers of exposure;
4. the weight of evidence supports the conclusion that menthol in cigarettes is associated with particular patterns of smoking;
5. the weight of evidence is not sufficient to support a conclusion that consumer perceptions are associated with the use of menthol cigarettes;
6. the weight of evidence supports the conclusion that menthol in cigarettes is likely associated with increased initiation and progression to regular of cigarette smoking;
7. the weight of evidence supports the conclusion that menthol in cigarettes is likely associated with increased dependence; 
8. the weight of evidence supports the conclusion that menthol in cigarettes is likely associated with reduced success in smoking cessation, especially among African American menthol smokers; and
9. the weight of evidence supports the conclusion that menthol in cigarettes is not associated with an increase in disease risk to the user compared to non-menthol cigarette smokers.

The final conclusion of the report is as follows: "While there is little evidence to suggest that menthol cigarettes are more or less toxic or contribute to more disease risk to the user than nonmenthol cigarettes, adequate data suggest that menthol use is likely associated with increased smoking initiation by youth and young adults. Further, the data indicate that menthol in cigarettes is likely associated with greater addiction. Menthol smokers show greater signs of nicotine dependence and are less likely to successfully quit smoking. These findings, combined with the evidence indicating that menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes."

The Rest of the Story

The FDA's report adds very little beyond what we already knew and very little beyond what the Tobacco Products Scientific Advisory Committee (TPSAC) already concluded. In fact, you could summarize the findings of the FDA report as follows:

"FDA Concludes that Menthol Cigarettes are No More Hazardous, But That They Enhance Smoking Initiation By Masking Harshness of Tobacco."

Incidentally, the title of my March 2, 2011 post was:

"FDA Advisory Committee Concludes that Menthol Cigarettes are No More Hazardous, But That They Enhance Smoking Initiation By Masking Harshness of Tobacco."

So we are in no different a place scientifically as we were 17 months ago. The only thing that has happened is that the FDA has delayed any decision or action on menthol for 17 months. Although some might view this as a benefit to tobacco companies, I think they (Lorillard especially) would appreciate having some inclination of what FDA plans to do about menthol cigarettes. This would help immensely in planning purposes and potential preparation if there are going to be regulatory changes.

Readers should also recognize that this report has no new implications for policy and offers no hint as to what action the FDA might or might not take. All options, including doing nothing, are still on the table. The report doesn't provide any hints about what FDA might do because the decision is essentially a political and policy decision, not a scientific one.