FDA Issues Preliminary Report on Menthol in Cigarettes

Thomas A. Briant, NATO Executive Director

Earlier this week, the U.S. Food and Drug Administration (FDA) issued a press release announcing an “Advance Notice of Proposed Rulemaking” to seek additional information and comments from the public to make informed decisions about the use of menthol in cigarettes (a copy of the press release accompanies this bulletin). The press release states that the FDA is issuing the advance notice “to obtain additional information related to potential regulatory options it might consider, such as establishing tobacco product standards, among others.” 

This does not mean that the FDA has decided to issue proposed regulations about the use of menthol in cigarettes, but rather is an additional step the agency is taking to obtain public input on menthol before deciding whether or not to issue any proposed regulations on menthol cigarettes. 

In addition to the press release, the FDA issued a 153-page report titled “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Non-Menthol Cigarettes,” a copy of which accompanies this bulletin.  In this evaluation report, the FDA specifically states as follows:

“This document is a scientific assessment of public health issues related to the use of menthol in cigarettes.This document does not constitute a decision about what regulatory action, if any, FDA might take with respect to menthol in cigarettes.If FDA determines, after reviewing all of the available information from this assessment and the anticipated public comments, from the TPSAC report and associated public comments, and from the tobacco industry perspective document, that restrictions on the sale and/or distribution of menthol cigarettes or product standards should be established, the Agency would do so pursuant to rulemaking procedures that include public notice and an opportunity for public comment.There is no required deadline or timeline for FDA to make a determination about what regulatory action, if any, is appropriate.”

Preliminary Scientific Evaluation Report

The Family Smoking Prevention and Tobacco Control Act, the law that authorized the Food and Drug Administration to regulate tobacco products, required the establishment of a Tobacco Product Scientific Advisory Committee (TPSAC) to submit a report and recommendation to the FDA on the impact of the use of menthol in cigarettes on the public health. In July of 2011, the TPSAC submitted a report to the FDA that concluded, “removal of menthol cigarettes from the marketplace would benefit public health in the United States.” The TPSAC report did not make any specific recommendations for the FDA to take on menthol in cigarettes. Also, the three non-voting tobacco industry members of the TPSAC submitted a separate report reflecting the industry’s perspective and also noted the possibility of contraband and black market menthol cigarettes if the FDA were to enact a ban on menthol use in cigarettes.

In response, the FDA reviewed all of the information and data submitted to the TPSAC regarding menthol in cigarettes and then commissioned additional scientific review of the information to obtain as much knowledge as possible on menthol in cigarettes. This entire review process conducted by the FDA is now detailed in the agency’s 153-page preliminary report.

Summary Findings of Preliminary Evaluation of Menthol vs. Non-Menthol Cigarettes

The 153-page preliminary evaluation report issued by the FDA divided the scientific evidence into nine different broad categories. A summary of the evidence in each of the categories is as follows:

Smoke Chemistry and Non-Clinical Toxicology: Two main areas of interest involved the comparison of menthol to non-menthol cigarettes and whether menthol impacted the presence and levels of harmful or potentially harmful smoke constituents. The evidence showed that menthol in cigarettes does not increase or decrease smoke toxicity.

Physiology: The agency considered scientific information on menthol’s effect on cooling and desensitizing a smoker’s physiology. The evidence supports the conclusion that menthol in cigarettes is likely associated with altered physiological responses to tobacco smoke.

Biomarkers: The FDA analyzed studies measuring a smoker’s biomarkers (the level of smoke constituents in exhaled air, saliva, blood and urine). Based on the studies, the FDA concludes that menthol in cigarettes is likely not associated with an increase or decrease in biomarker levels.

Patterns of Use: The agency reviewed scientific literature on the general trends and patterns in smoking menthol cigarettes. The studies support the conclusion that a majority of African American smokers smoke menthol cigarettes, other minority groups are also more likely to smoke menthol cigarettes as compared to white smokers, younger smokers have the highest rate of smoking menthol cigarettes, and female smokers are more likely to smoke menthol cigarettes than male smokers.

Marketing and Consumer Perception of Risk: The FDA reviewed studies on brand preference, advertising, marketing and consumer perception of risk. The available data suggests that advertising is a strong driver of brand preference among some groups of menthol smokers and that just like non-menthol cigarettes, the marketing of menthol cigarettes is associated with brand preference. Also, the weight of evidence is not sufficient to support a conclusion that consumer perceptions are associated with the use of menthol cigarettes.

Initiation and Progression to Regular Use: The agency assessed data on the possible impact of menthol cigarettes on an individual’s initiation in smoking and their progression to the regular smoking of cigarettes. The studies support the conclusion that menthol in cigarettes is likely associated with an increase in smoking initiation and a progression to regular cigarette smoking.

Dependence: The FDA reviewed studies utilizing a variety of measures of nicotine dependence and/or craving (i.e., number of cigarettes per day, time upon waking to first cigarette, and craving). The study information supports the conclusion that menthol in cigarettes is likely associated with increased dependence.

Cessation: The agency analyzed studies that questioned whether menthol smokers were more likely to be successful at quitting smoking. While the various studies have different conclusions with some studies failing to find an association between menthol smoking and the ability to stop smoking, the FDA report states that the evidence supports the conclusion that menthol in cigarettes is likely associated with a reduced success rate in quitting smoking, especially among African American smokers.

Disease Risk: The FDA analyzed studies on the impact of disease risk based on smoking menthol or non-menthol cigarettes. The evidence supports the conclusion that menthol in cigarettes is not associated with an increase in disease risk versus a smoker of non-menthol cigarettes.