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Government Weighs Action Against Menthol Cigarettes

Are menthol cigarettes more harmful than regular cigarettes? Does menthol's minty flavor make it easier to start smoking? Are they more addictive or harder to quit?

The U.S. Food and Drug Administration's new Tobacco Products Scientific Advisory Committee wants answers to those questions and more as it decides whether to recommend that the government increase regulation of popular menthol cigarettes.

The Family Smoking Prevention and Tobacco Control Act, enacted last year, gave the FDA broad new powers to regulate tobacco products. It also called for establishment of the advisory committee.

The committee has a year to submit a report to the secretary of Health and Human Services, after which the FDA will decide whether further regulatory action is warranted. The inquiry went public with two days of hearings in Washington, D.C., in late March.

The new law banned fruit and candy-like flavorings from cigarettes, but menthol was exempted for political reasons, said Mitch Zeller, who was director of the FDA's Office of Tobacco Programs during the Clinton Administration. He is now vice president for policy and strategic communications at Pinney Associates, pharmaceutical and healthcare consultants based in Bethesda, Md.

Instead, Zeller said, the legislation called on the advisory committee to take up the issue of menthol as its first order of business.

"I am reasonably confident answers to many of those questions lie in the filing cabinets of the tobacco companies, especially those related to marketing, consumer behavior and product dosing, such as: Why did they add menthol? Why did they add it at certain levels? And how do they add it in the manufacturing process?" Zeller said.

With a minty flavor that disguises the bitter taste of burning tobacco, menthol is a popular cigarette flavor. Sales of menthols account for an estimated one-fifth to one-third of the $70 billion U.S. cigarette market.

More than 80 percent of African American smokers favor menthols, according to the 2007 National Survey on Drug Use and Health, conducted by the Substance Abuse and Mental Health Services Administration.

The racial implications make the menthol issue even more complicated, Zeller said. Some want menthols banned because they contend that marketers have targeted one racial group with a deadly product, but another school of thought is that banning a product used so heavily by one racial group would be unfair.

Cheryl Healton, president and chief executive of the American Legacy Foundation, who testified at the hearing, said she thinks menthol should have been included in the ban along with other flavored cigarettes. Menthol is especially dangerous because the taste masks the harshness of cigarettes, making it easier to take up the habit, Healton said. Her foundation, an anti-smoking organization based in Washington, D.C., was founded in 1999 with funding from the landmark tobacco settlement between the industry and state governments.

The American College of Physicians is expected to take a stand on the issue soon. On April 20, the Board of Regents will decide whether to approve a policy urging the FDA to ban menthol as a flavoring in all tobacco products.

The smooth flavor of menthol cigarettes has also been blamed for luring kids into smoking. According to a report last year by the Centers for Disease Control and Prevention, Newport menthol cigarettes were second only to Marlboro as the cigarettes most middle school students said they smoked.

"It's clear the industry figured out they could attract more black smokers if they reduced the harshness of cigarettes by adding the mint flavor," Healton said. "My hope is that the FDA taking this up as one of the first issues is a signal they realize they can reduce youth smoking by the prohibition of menthol."

Lorillard Tobacco Co., the makers of Newport, issued a statement March 30, the first day of the committee hearings, that menthol cigarettes are no more dangerous than other cigarettes.

"Menthol, obviously, has been used for decades in food, drink, cosmetics and other products," it said. "And the science is clear and compelling that there is no differing health risk between menthol and non-menthol products. With respect to public health, using the best methods available to science, it is clear a menthol cigarette is just another cigarette and should be treated no differently."

Under the new law, tobacco companies are required to disclose comprehensive information about the contents and manufacturing process for tobacco products. It gives the FDA more power over the industry than it had before, but the agency cannot ban all cigarettes outright, nor can it force cigarette companies to reduce nicotine levels to zero.

Still, the fact that the FDA can now require tobacco companies to turn over internal studies and manufacturing information is a major step in the anti-smoking battle, Zeller said.

"Finally we are going to be getting answers to questions about safety and why the industry does what it does, with a science-based public health agency asking the questions as opposed to well-intended researchers going where they can to gets bits of information," Zeller said.

"For 50 years, the public health community and the government have been playing catch-up with the tobacco industry," he said. "This legislation is going to shorten the distance between what we know and what they know."

The FDA advisory committee has nine voting members -- mostly physicians, scientists and public health experts -- plus three non-voting members representing the tobacco industry.

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April 15, 2010
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