F.D.A. to Examine Menthol Cigarettes

For the cigarette industry, the menthol debate is about to flare up again.

The new federal advisory board for tobacco regulation plans to meet for the first time Tuesday in Washington. Topping the agenda is one of the most contentious, and racially charged, health issues that Congress deferred last year when it empowered the Food and Drug Administration to regulate tobacco for the first time.

The question: what to do about menthol flavorings in cigarettes, which account for almost a third of the nation’s $70 billion cigarette market?

Opponents of smoking, seven former secretaries of health and many members of Congress argued for an outright ban of menthol in the tobacco law last year. They said that the flavoring, which cools and masks the harsh taste of cigarettes, was used as a lure for young smokers while also being marketed to black smokers, who have the highest rates of smoking-related disease.

But when the issue threatened to split the bill’s coalition of backers — including the industry giant Altria, which owns Philip Morris — Congress passed the issue on to the F.D.A. and gave it a two-year deadline to propose new regulations.

So it is no coincidence that menthol will be the first matter taken up by the F.D.A.’s new Tobacco Products Scientific Advisory Committee when it begins a two-day meeting on Tuesday.

Nor was it surprising that the cigarette industry chose to fill its one, nonvoting seat on the committee with an executive from Lorillard Tobacco of Greensboro, N.C. That company’s Newport is the nation’s leading menthol brand, and mentholated accounted for 91.5 percent of Lorillard’s $5.2 billion in revenue last year.

Dr. Jonathan Samet, the chairman of the advisory panel and head of preventive medicine at the University of Southern California, declined to discuss the possibility of an outright ban on menthol.

The scientists’ job is first to review evidence before recommending what changes could be made to products, he said in an interview. Under the law, the F.D.A. is to issue a report on menthol next year and take action by 2012.

“We’ve spent a lot of time working on the dangers of smoking, but now we’re going to be taking a somewhat different approach,” said Dr. Samet. “We’ll be trying to understand what it is in the products that harm people and what changes can be made.”

Menthol brands are preferred by 75 percent of African-American smokers. And while studies indicate that blacks smoke fewer cigarettes a day than other categories of smokers, they have greater rates of lung cancer, heart disease and strokes. The Congressional Black Caucus, complaining of predatory marketing, was among the groups that had urged stronger action against menthol in the legislation.

Critics also say menthol levels have been manipulated to attract underage first-time smokers.

But the industry, which says menthol is just one of many flavor differences among legal products for adult consumers, denies it markets to young smokers. And it says there is no evidence that menthol causes more people to start smoking. Tobacco companies also say menthol does not pose any greater risk to public health than other types of cigarettes.

“Epidemiological studies suggest no effect of menthol on smoking-related diseases,” Brendan J. McCormick, a spokesman for Altria, said Monday.

The cigarette industry’s nonvoting representative on the panel is Dr. J. Daniel Heck, principal scientist at Lorillard. This year, Dr. Heck, who holds a doctorate in pharmacology and toxicology, published a review of menthol studies in the journal Food and Chemical Toxicology, saying menthol did not make cigarettes more toxic but that more study was needed on its effect on “complex human behaviors” of smoking initiation and addiction.

Half of long-term smokers eventually die of smoking-related causes, according to the World Health Organization. In passing the tobacco law last year, Congress told the F.D.A. to improve public health short of an outright prohibition on cigarettes.

Congress specifically banned some seldom-used flavorants like candy flavors, but left it up to the F.D.A. to resolve many far-more difficult issues, including so-called reduced harm products, alternatives to cigarettes — and menthol.

The advisory committee is expected to hold at least one more meeting on menthol, this summer. Later, the group is expected to consider dissolvable products like Camel Orbs, a tobacco and mint pellet now being test marketed by R. J. Reynolds, and nicotine levels in cigarettes, among other issues, an F.D.A. statement said.

Several leading public health experts were among the nine scientists the F.D.A. appointed to the committee, including Gregory N. Connolly, director of the Tobacco Control Research Program at the Harvard School of Public Health; Dr. Neal L. Benowitz, University of California, San Francisco, medical professor and nicotine expert; and Dr. Mark S. Clanton, chief medical officer of the American Cancer Society.

The panel includes “no extremists” against cigarettes and no one who has previously said menthol should be limited or banned, according to a recent investor note from David J. Adelman, industry analyst for Morgan Stanley.

Mr. Adelman said it was unlikely that the F.D.A. would ban menthol because of the lack of evidence it added harm to cigarettes and the prospect that a ban would set up a huge underground market. Mr. Adelman said the fact that millions of Americans smoke menthol cigarettes made it impractical to ban the additive.

“If it were 1 percent of the market, the implication to commerce and retail and consumers would be much more manageable,” he said in an interview.

Mr. Adelman says he expects the panel may eventually recommend added warnings on menthol products, perhaps saying they are no safer than regular cigarettes; additional marketing restrictions and possibly a reduction in menthol levels over time. A Credit Suisse report said the government could also set higher prices for menthol cigarettes.

March 29, 2010

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