FDA Evaluation Indicates Menthol Likely Impacts Public Health

SILVER SPRING, Md. -- More than two years since the Food and Drug Administration (FDA) began reviewing menthol, the agency is taking steps to settle the menthol debate.

A new preliminary independent evaluation released by the FDA, Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes, found that "the preliminary scientific evaluation indicates there is likely a public health impact [from] menthol in cigarettes." However, there may still be miles to travel on the road to any definitive stance on menthol cigarettes.

In a briefing this afternoon, Mitch Zeller, director of the FDA's Center for Tobacco Products, stressed that the agency is now in an "information-seeking mode" and not issuing a final ruling.

"We are pleased that progress is being made on menthol, particularly since the FDA has reiterated that menthol is one of its top priorities," said Bonnie Herzog, managing director of tobacco, beverage and consumer research at Wells Fargo Securities LLC. "However, we expect it could still be a long time until some type of final resolution is ultimately reached."

Herzog pointed out that the language in the FDA's latest report is "softer" than the language used by the Tobacco Product Scientific Advisory Committee (TPSAC) when it issued its menthol findings in March 2011. She said this suggests that "a ban is unlikely." TPSAC in its report recommended that removing menthol cigarettes from the market would benefit public health.

The FDA is now giving the public a chance to weigh in on this matter. It issued an Advanced Notice of Proposed Rulemaking, which opens a 60-day public comment period.

"[The] 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," Zeller said.

In addition, the agency 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 non-menthol cigarettes; and a third to examine the effects of menthol and non-menthol compounds in various tobacco products on both tobacco addiction and toxicants of tobacco smoke.

The FDA is also developing a youth education campaign focused on preventing and reducing tobacco use, including menthol cigarettes.

Click here to review the preliminary independent evaluation, Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes.