WASHINGTON -- Saying that "preliminary scientific evaluation indicates there is likely a public health impact of menthol in cigarettes" the U.S. Food & Drug Administration (FDA) stopped short of making a recommendation on whether to limit or ban the flavored cigarettes.
As reported in a Raymond James/CSP Daily News Flash, the federal agency issued an advance notice of proposed rulemaking (ANPRM) to obtain information related to the potential regulation of menthol in cigarettes. It is seeking comments, data, research or other information that may inform regulatory actions it might take with respect to menthol in cigarettes.
"Menthol cigarettes raise critical public health questions," said FDA Commissioner Margaret A. Hamburg, M.D. "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 FDA also made available from its Center for Tobacco Products (CTP) preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes. In fact, it found that "menthol cigarettes pose a public health risk above [emphasis added] that seen with nonmenthol cigarettes."
The report, entitled Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes, said, "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."
"We are pleased that progress is being made on menthol, particularly since the FDA has reiterated that menthol is one of its top three priorities; however, we expect it could still be a long time until some type of final resolution is ultimately reached," said Bonnie Herzog, managing director, beverage, tobacco and convenience store research for Wells Fargo Securities LLC, New York, said in a research note. "We believe it's unlikely that menthol will be banned, though we recognize that this issue may continue to be an overhang."
She added, "We believe the language in the FDA's report ... is somewhat softer than the menthol language from TPSAC's recommendation that "removal of menthol cigarettes from the marketplace would benefit public health in the United States'--suggesting that a ban is very unlikely."
The Family Smoking Prevention & Tobacco Control Act, enacted on June 22, 2009, provides the FDA with the authority to regulate tobacco products. It requires the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) to submit a report and recommendations to the Secretary of Health & Human Services on the impact of the use of menthol in cigarettes on the public health, including use among children, African Americans, Hispanics and other racial/ethnic minorities.
TPSAC has submitted the report to HHS.
In addition, the nonvoting industry representatives of TPSAC submitted a separate document reflecting the industry perspective.
Two cigarette manufacturers have challenged FDA's ability to rely on TPSAC's menthol report, and that case is currently pending (Lorillard Inc. v. FDA).
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.
"FDA'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," said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products.
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 subbrands. 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.
Anti-tobacco advocacy group Legacy said that "seeking additional information regarding the potential regulation of menthol in cigarettes is an unnecessary regulatory step, further delaying action that could save American lives."
David Dobbins, COO at Legacy, said, "The FDA does not need more information on this issue. It needs to remove menthols from the market."
Watch for more details on the menthol issue in today's issue of Tobacco E-News.