FDA: Menthol makes it harder to quit smoking

RICHMOND, Va. - Removing menthol cigarettes from the market would benefit public health because the minty flavoring has led to an increase in the number of smokers and makes it harder for people to quit, a Food and Drug Administration advisory panel said Friday.

The agency's Tobacco Products Scientific Advisory Committee stopped short of recommending an outright ban of menthol cigarettes. The FDA should consider other factors, the advisers said, including that a ban could increase counterfeit and smuggled cigarettes.

"The availability of menthol cigarettes has an adverse impact on public health by increasing the number of smokers with resulting premature death and avoidable mortalities," committee member Mark Clanton, chief medical officer at the American Cancer Society, said in his summary of the report.

Panels like the tobacco committee advise the FDA on scientific issues. The agency doesn't have to follow their recommendations but often does. Many analysts believe it won't ban menthol. About 19.2 million American smoke menthol cigarettes, according to a study cited in a draft of the panel's report.

But "these days ... the certainty (of the FDA following advisory committee's recommendations) has dropped from over 90 percent to about 70 percent," said Ira Loss, an analyst with Washington Analysis who has covered the agency for three decades.

Loss said his group believes a ban won't happen.

"We just think this is too much of a political hot potato," Loss said.

Lawrence Deyton, director of the FDA's Center for Tobacco Products, signaled a ban is not a sure thing. While there is no timeline for the agency to take action, the FDA intends to provide a progress report in about 90 days.

"I need to be very clear. ... The report does not set FDA policy, does not set FDA actions," Deyton said. "Receipt of the final report will not have direct, immediate effect on the availability of menthol products."

While the panel said menthol smokers are not likely to be at a higher risk of disease or exposed to a greater number of toxins, menthol cigarettes make it more likely for certain groups like youth and African Americans to experiment with smoking and make it harder for them to quit.

The panel said more research is needed and said the federal agency should develop a program to monitor the marketing of menthol cigarettes. It also suggested that should the FDA choose to recommend a ban or other restrictions, the agency should study the potential for contraband menthol cigarettes, a concern raised by the tobacco industry and other trade groups.

A menthol ban or other restrictions on the flavored cigarettes would fall heavily on Lorillard Inc., whose Newport brand is the top-selling menthol cigarette in the U.S., with roughly 35 percent of the market. Menthol cigarettes are one of the few growth areas in a shrinking cigarette market.

Lorillard, the country's third-largest tobacco company, is based in Greensboro, N.C. The company did not provide immediate comment.

Draft chapters of the FDA panel's report also say menthol cigarettes may not be more risky, but their use is highest among minorities, teenagers and low-income people.

There's evidence consumers perceive that menthol cigarettes offer some form of health protection or medicinal benefit that non-menthol cigarettes don't, according to the drafts. That report says menthols are disproportionately marketed to African Americans and younger smokers.

The report due to the FDA next Wednesday was mandated under the 2009 law giving the agency the authority to regulate tobacco. The FDA can't ban nicotine or tobacco, but it can limit what goes into tobacco products, require the ingredients be publicized and limit marketing, especially to young people.

Meanwhile, a tobacco industry report to the FDA acknowledges that "all cigarettes are hazardous to health" but says there's no scientific basis for regulating menthols differently.

Lorillard and Reynolds American Inc., which is based in Winston-Salem, N.C., and owns the nation's second-largest tobacco company, R.J. Reynolds Tobacco Co., maker of Camel and Pall Mall brand cigarettes, have asked a federal court to stop the FDA from relying on the advisory panel's recommendations. The tobacco companies claim members of the FDA panel have financial conflicts of interest and are biased.

Altria Group Inc., the owner of nation's biggest cigarette maker, Marlboro maker Philip Morris USA, plans to submit separate menthol findings and recommendations to the FDA. Altria, based in Richmond, Va., was the only major U.S. tobacco company to support FDA regulation.