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The U.S. Food and Drug Administration (FDA) has issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes, which are used by about 30% of all adult smokers and 40% of all youth smokers in the U.S.
The agency is issuing the ANPRM, which will be available for public comment for 60 days, to obtain additional information related to potential regulatory options it might consider, such as establishing tobacco product standards, among others. 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.
“Menthol cigarettes raise critical public health questions,” said Margaret A. Hamburg, FDA commissioner. “The 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.”
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 non-menthol 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.
Also, the FDA is developing a youth education campaign focused on preventing and reducing tobacco use, including menthol cigarettes.