July 22, 2013

Stanton A. Glantz, PhD

FDA menthol report is out, restates scientific consensus that menthol promotes initiation and deters cessation

The FDA has finally released its long-awaited menthol report and invited public comment and submission of additional information during the next 60 days.
Based on a quick reading it seems to essentially be agreeing with TPSAC's conclusions over two years ago.  Based on these conclusions, if the FDA proceeds based on  the science and the standard in the law, they need to ban menthol and its analogs.

A consequence of the FDA's conclusion that menthol -- and not just menthol as a "characterizing flavor" -- encourages initiation and deters cessation is that every month of delay means thousands of new smokers and thousands few quitters.
 
Here are the key conclusions (with some nonsubstantive bureaucratic language deleted):
From a nonclinical toxicity standpoint, menthol in cigarettes is not associated with increased or decreased smoke toxicity.

Menthol in cigarettes is likely associated with altered physiological responses to tobacco smoke.

Menthol in cigarettes is likely not associated with increased or decreased levels of biomarkers of exposure [CO, COHb and TSNAs].

A majority of African American smokers smoke menthol cigarettes, but other minority groups are also more likely to smoke menthol cigarettes as compared to Whites.

Younger populations have the highest rate of smoking menthol cigarettes, and female smokers are more likely to smoke menthol cigarettes than male smokers.

The use of menthol cigarettes is associated with lower socioeconomic status (SES).

Menthol in cigarettes is associated with particular patterns of smoking.

Like nonmenthol cigarettes, the marketing of menthol cigarettes is associated with brand preference.

The marketing of menthol cigarettes is associated with menthol brand preference among adolescents and the African American community.

Given the limited data reviewed and mixed results reported, the weight of evidence is not sufficient to support a conclusion that consumer perceptions [of risk] are associated with the use of menthol cigarettes.

Menthol in cigarettes is likely associated with increased initiation and progression to regular of cigarette smoking.

Menthol in cigarettes is likely associated with increased dependence.

Menthol in cigarettes is likely associated with reduced success in smoking cessation, especially among African American menthol smokers.

Menthol in cigarettes is not associated with an increase in disease risk to the user compared to non-menthol cigarette smokers.

Summary of Evidence

The impact of cigarette smoking upon public health is indisputable. More than 400,000 deaths per year in the United States are caused by tobacco use. Consistent patterns have emerged as a result of FDA’s evaluation of the scientific evidence relevant to the impact of menthol tobacco products on public health. 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.  [emphasis added]

The full report is available here.

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