Panel urges F.D.A. to review menthol in cigarettes

Posted: 3/18/2011

From The New York Times:

A federal advisory panel on Friday said removing menthol cigarettes from the market would benefit public health in the United States but did not make any specific recommendation for action by the Food and Drug Administration.

The F.D.A will review the findings of its Tobacco Products Scientific Advisory Committee and perform its own research and policy study, Lawrence R. Deyton, director of the F.D.A. Center for Tobacco Products, said Friday after the advisory group wrapped up a year of study.

The advisory panel's chairman, Dr. Jonathan M. Samet, a professor of medicine at the University of Southern California, said the committee had found a scientific basis for the added harm caused by menthol in cigarettes, a decision that could provide a legal basis for the F.D.A. to try to limit, phase out or even ban menthol in cigarettes.

The F.D.A., given the authority to regulate the contents of cigarettes by a 2009 law, will make a progress report in about 90 days, Dr. Deyton said. "Now it's up to us to do our job," he said.

Industry analysts said they believed the F.D.A. might take a moderate final action.

Any action, however, would pose a host of extremely difficult social and political issues and face a protracted legal challenge by the tobacco industry, which said a ban would have no public health benefit and open up a criminal black market.

Menthol accounts for an estimated 27 percent of the $80 billion cigarette market in the United States and 19 million smokers -- a disproportionate number of whom are African-Americans, younger and lower income. Menthol is preferred by more than 80 percent of black smokers, about 22 percent of white smokers, and nearly half of 12- to 17-year-old smokers.

The panel, in recommendations made public on Friday morning, said evidence showed that menthol led to more youth smoking, made it easier to start smoking and harder to quit.

"Menthol cigarettes have an adverse impact on the public health in the United States," Dr. Mark Stuart Clanton, chief medical officer of the American Cancer Society, High Plains Division, in Austin, Tex., said in summarizing the scientific findings.

The public health finding is the strongest statement yet by any government group in the world involving menthol flavors.

Congress had banned candy, fruit and spice flavorants in tobacco but deferred the politically difficult issue of menthol to the F.D.A.

Under the law, the panel was required to consider the impact of menthol on public health and the likelihood it made it easier to start or harder to quit smoking.

Matthew L. Myers, president of the Campaign for Tobacco -Free Kids, said, "They've shown menthol increases youth usage significantly, which is a trigger for action."

Any government action would be preceded by a proposed rule and another round of public comments and no doubt, lawsuits. Two tobacco companies filed a lawsuit last month to try to block the advisory committee action or force the F.D.A. to disregard its advice, saying panel members were biased and had financial conflicts of interest from legal and consulting work against tobacco companies, a claim the F.D.A. denied. 

Lorillard Tobacco of Greensboro, N.C., which is more than 90 percent reliant on revenue from menthol products and makes the top brand, Newport, is leading the opposition to F.D.A. action and one of its scientists is a nonvoting member of the F.D.A. panel. Jonathan Daniel Heck, Lorillard's principal scientist, issued the industry view Thursday saying there was no evidence that menthol promoted youth smoking or made it harder to quit.

Menthol provides a cooling sensation that masks the harsh taste of tobacco. Menthol levels have been manipulated to be lower for starter products like Newport, according to findings of the panel based partly on industry documents. Industry research shows younger smokers prefer some but not too much menthol.

Dr. Dorothy K. Hatsukami, a panel member and professor from the Tobacco Use Research Center at the University of Minnesota, said scientific literatures showed smokers who started younger were more likely to have trouble quitting and to die from smoking. "This is the population that's particularly vulnerable to the effects of menthol cigarette smoking," Dr. Hatsukami said.

Menthol has also been advertised over the years for claimed health benefits and it has been heavily advertised in African-American communities and magazines. Dr. Melanie Wakefield, an advisory panel member and director of an Australian research center, said menthol cigarettes continued to be marketed with images including the color green that falsely suggested they were healthier.

But Lorillard said the smoking rate of African-American youth was half that of white youth. The company also says there was "no difference in quit-smoking rates between menthol and non-menthol smokers." Dr. Heck of Lorillard dismissed the false marketing claims as artifacts of decades past - although Dr. Wakefield said their effect persists.

More broadly, health groups say the menthol issue poses the first real test of the advisory committee and F.D.A. toughness against cigarettes. The recommendation may signal a willingness to crack down on nicotine, the addictive ingredient in tobacco products. Levels of nicotine, like menthol, have been manipulated by companies to fulfill marketing aims.

The law allows the F.D.A. to regulate tobacco product ingredients but not to ban cigarettes or nicotine entirely.

Original here.