Menthol is a flavor additive widely used in consumer and medicinal products; however, its use in tobacco products is not currently regulated. It has a minty taste and aroma, and may have cooling or painkilling properties – which can reduce the irritation and harshness of smoking when used in cigarettes.
Inviting Public Input on Menthol in Cigarettes
Menthol cigarettes raise critical public health questions. On July 23, 2013, the FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) to take public input on menthol in cigarettes. Specifically, the FDA is requested information to inform its thinking about potential regulatory options such as:
- tobacco product standards;
- sale and distribution restrictions; and
- other regulatory actions and considerations.
The FDA also conducted a preliminary independent scientific evaluation of existing data and research on menthol cigarettes. The Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes addresses the association between menthol cigarettes and various outcomes, including:
- addiction; and
The preliminary scientific evaluation, along with other relevant scientific information on the topic of menthol, was included for 122 days in the docket for the ANPRM to give all interested parties an opportunity to comment. The FDA will consider all comments, data, research, and other information submitted to the docket to determine what, if any, regulatory action with respect to menthol in cigarettes is appropriate. If the FDA decides to issue a rule, the first step in that process would be a Notice of Proposed Rulemaking, which would give the public an opportunity to weigh in on the specifics of the proposed rule.
Supporting New Research
The FDA is committed to a science-based approach that addresses the public health issues raised by menthol cigarettes. To further the FDA’s understanding of the likely public health impact of the use of menthol in cigarettes, the FDA plans to support new research on the differences between menthol and nonmenthol cigarettes, including:
- menthol’s likely impact on smoking cessation;
- menthol’s likely impact on attempts to quit; and
- the levels of menthol in cigarette brands and subbrands.
- a study to look at genetic differences in taste perceptions in tobacco use, which may further the understanding of why certain racial/ethnic populations are more likely to use menthol cigarettes [Genetic Factors in Taste Perception and Tobacco Usage];
- a study to examine the effects of menthol in cigarettes by assessing human exposure to smoke-related toxins and carcinogens by comparing cigarettes that are the same except for the levels of menthol in them [Real-Time Measurement and Uptake of Carcinogens by Menthol Cigarette Smokers]; and
- a study to examine the effects of menthol and nonmenthol compounds in various tobacco products on both tobacco addiction and toxicants of tobacco smoke [Counter-Irritation by Menthol: Molecular Targets and Role in Airway Disease].
Information received in response to the ANPRM, as well as new scientific research, will help the agency make the best decisions about possible regulatory actions.
Resources for You
- [11/22/13 CLOSED DOCKET]: Menthol in Cigarettes, Tobacco Products; Request for Comments (Advance Notice of Proposed Rulemaking)
- [9-10-13] Federal Register Notice: Menthol in Cigarettes, Tobacco Products; Request for Comments; Extension of Comment Period
- FDA’s Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes
- Reference Addendum: FDA’s Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes
- Tobacco Products Scientific Advisory Committee (TPSAC): Report and Recommendations on the Impact of the Use of Menthol in Cigarettes on the Public Health