FDA seeks additional information to make informed decisions about menthol in cigarettes

Food and Drug AdministrationJul 24 2013

Today, the U.S. Food and Drug Administration issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes. Despite decades of work to reduce tobacco use in the United States, it continues to be the leading cause of preventable death and disease. In the United States, about 30 percent of all adult smokers and more than 40 percent of all youth smokers report smoking menthol cigarettes.  &quotMenthol cigarettes raise critical public health questions,&quot said FDA Commissioner Margaret A. Hamburg, M.D. &quotThe FDA is committed to a science-based approach that addresses the public health issues raised by menthol cigarettes, and public input will help us make more informed decisions about how best to tackle this important issue moving forward.&quot The agency is issuing the ANPRM to obtain additional information related to potential regulatory options it might consider, such as establishing tobacco product standards, among others. 

The ANPRM will be available for public comment for 60 days. 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. &quotFDA's actions today on menthol reflect our commitment to explore all potential options, including the establishment of product standards. In the meantime, we will conduct new research to further inform our decision making,&quot said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products. The agency is also making available for public comment relevant scientific information, including the FDA's independent Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes. The preliminary evaluation addresses the association between menthol cigarettes and various outcomes, including initiation, addiction, and cessation. In addition, the FDA plans to support new research on the differences between menthol and nonmenthol cigarettes as they relate to menthol's likely impact on smoking cessation and attempts to quit, as well as assessing the levels of menthol in cigarette brands and sub-brands. The FDA is funding three menthol-related studies; one to look at whether genetic differences in taste perceptions explain why certain racial and ethnic populations are more likely to use menthol cigarettes; the second to compare exposure to smoke-related toxins and carcinogens from menthol and nonmenthol cigarettes; and a third to examine the effects of menthol and nonmenthol compounds in various tobacco products on both tobacco addiction and toxicants of tobacco smoke. Finally, the FDA is developing a youth education campaign focused on preventing and reducing tobacco use, including menthol cigarettes.