In a long-awaited decision, an advisory panel to the U.S. Food and Drug Administration on Friday said that menthol cigarettes are harmful and their removal "from the marketplace would benefit public health in the United States."
The Tobacco Products Scientific Advisory Committee also said that menthols' minty flavor may make smoking more attractive, spurring youth and especially blacks (who tend to favor menthol cigarettes) to try the habit.
"Menthol cannot be considered merely a flavoring additive to tobacco. Its pharmacological actions reduce the harshness of smoke and the irritation from nicotine, and may increase the likelihood of nicotine addiction in adolescents and young adults who experiment with smoking," the panelists said in their report. "Furthermore, the distinct sensory characteristics of menthol may enhance the addictiveness of menthol cigarettes, which appears to be the case among youth."
In fact, the experts said that a close look at the data suggests that menthol cigarettes "contributes to nicotine dependence in at least the 30 percent of adult smokers" who use them.
The panel did say that menthol cigarettes pose no greater health risk to smokers than other cigarettes in terms of their odds for lung cancer and other respiratory illnesses.
Still, pulling menthols off the market could save many lives, the panel said. "Assuming the best estimates, by 2020 about 17,000 premature deaths will occur and about 2.3 million people will have started smoking, beyond what would have occurred absent availability of menthol cigarettes," they concluded.
While the FDA does not have to abide by the advice of its advisory panels, it typically does.
In a statement released Friday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said that, "although there is no required deadline or timeline for FDA to act on the issue of menthol in cigarettes, we recognize the strong interest in this issue among all stakeholders and will continue to communicate the steps the FDA is taking as it determines what future regulatory actions, if any, are warranted." The first "progress report" on any proposed regulations is due within 90 days, he added.
Many anti-smoking organizations have long hoped that the FDA will eventually bar menthols from the marketplace.
"Menthols should be banned, and such a decision would be, in the words of the statute, 'appropriate for the protection of the public health,'" said Ellen Vargyas, general counsel for the American Legacy Foundation, a Washington, D.C.-based advocacy organization that was founded in 1999 with funding from the landmark Master Settlement Agreement between the tobacco industry and state governments.
Friday's decision comes on the heels of a statement issued Thursday by the same panel that found that marketing messages for menthol cigarettes disproportionately target youths and blacks and are crafted to imply that menthols are safer than other cigarettes, although they are not.
"Analyses of tobacco industry internal documents and marketing messages the industry produced provide corroborating evidence of explicit and unwarranted claims that smoking menthol cigarettes would improve smokers' health," the draft report stated. "Over time, marketing messages increasingly relied on sensory descriptors and imagery to imply that menthol cigarettes are safer than non-menthol cigarettes."
The draft report also says that menthol marketing has targeted youth, women and blacks, and that "consistent with these targeted marketing efforts, menthol cigarettes are disproportionately smoked by African-American smokers."
According to a study cited in the FDA's draft report, nearly 81 percent of black middle schoolers who smoke and about 85 percent of black high school smokers regularly smoke menthol cigarettes. That is in contrast to about 43 percent of white middle school smokers and 37 percent of white high school smokers.
The panel was tasked with determining how menthol cigarettes should be regulated and whether the science justifies an outright ban.
"We think there are two key scientific underpinnings [to the argument for a ban]," said Vargyas, from the American Legacy Foundation. "One is the link between menthol smoking and youth initiation. The science shows the younger and the newer the smoker, the more likely they are to smoke menthols. The second very important reason is the science shows they make more quit attempts than non-menthol smokers, but they are less successful at quitting."
The efforts to more stringently regulate tobacco products come as a the result of the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in June 2009. The law gave the FDA broad new powers to regulate the sale, marketing and content of tobacco products and directed the FDA to establish an advisory committee to review the science and make recommendations.
The law banned fruit and candy-like flavorings from cigarettes, but exempted menthol, by far the most popular flavor. Menthol accounts for 27 percent of all cigarettes sold in the United States in 2009, according to the FDA's report.
Instead, menthol became the Tobacco Products Scientific Advisory Committee's (TPSAC) first order of business.
On Feb. 25, Lorillard Inc., the Greensboro, N.C-based maker of Newports, R.J. Reynolds Tobacco Co., based in Winston-Salem, N.C. and the makers of Camel and Winston, sued the FDA and asked the court to prevent the agency from considering recommendations from the advisory committee. The tobacco companies contend that several members of the committee have a conflict of interest.
And that's almost certainly not the last of the lawsuits from the tobacco companies, Vargyas noted.
The FDA will now begin to craft a proposed rule, experts say, and then the public and the tobacco industry will have time to weigh in with their opinions.