The federal agency released the independent review on Tuesday and is seeking input from the health community, the tobacco industry and others on possible restrictions on the mint-flavored cigarettes.
The FDA evaluation concluded that there is little evidence to suggest that menthol cigarettes are more or less toxic or contribute to more disease risk to smokers than regular cigarettes. However, there is adequate data to suggest that menthol use is likely associated with increased smoking initiation by younger people and that menthol smokers have a harder time quitting, the review said.
There's also evidence indicating that menthol's cooling properties can reduce the harshness of cigarette smoke and that menthol cigarettes are marketed as a smoother alternative, the review said.
"Menthol cigarettes raise critical public health questions," Mitch Zeller, director of the Center for Tobacco Products, said in a conference call with reporters.
Zeller said there's "no holdup" on the FDA proposing restrictions on menthol but that there are still "some important questions" that need to be answered. The agency is commissioning further research.
A 2011 FDA advisory panel report, which was mandated under the 2009 law giving the agency the authority to regulate tobacco, made many of the same findings, and said that removing menthol cigarettes from the market would benefit public health and highlighted greater use among minorities, teenagers and low-income people. Panels like the tobacco committee advise the FDA on scientific issues. The agency doesn't have to follow its recommendations, but often does.
Meanwhile, a tobacco industry report to the FDA acknowledged that all cigarettes are hazardous but said there's no scientific basis for regulating menthols differently. The industry also has raised concerns that restrictions on menthol would lead to a black market for the cigarettes.
Menthol cigarettes are one of the few growth areas in a shrinking cigarette market. The percentage of U.S. cigarette smokers using menthol brands grew from 33.9 percent in 2008 to 37.5 percent in 2011, according to a study by the federal Substance Abuse and Mental Health Services Administration, with more significant growth among younger smokers.
A menthol ban or other restriction on the flavored cigarettes would fall heavily on Greensboro, N.C.-based Lorillard Inc., whose Newport brand is the top-selling menthol cigarette in the U.S., with nearly 38 percent of the market. Lorillard, the country's third-largest tobacco company, did not immediately comment on the FDA's latest findings.
The move comes ahead of a Wednesday deadline for the U.S. to respond to the World Trade Organization's findings last year that the FDA's ban on manufacturing, importing, marketing and distributing candy-, fruit- and clove-flavored tobacco breaks trade rules because it exempts menthol cigarettes, most of which are made in the U.S.. The investigation was launched following a request from Indonesia, which claims more than 6 million of its people depend on the production of clove cigarettes -- a staple of the country's smoking culture.
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