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FDA Panel Says Menthol Cigarettes Harmful

MedpageToday

WASHINGTON -- Removing menthol from cigarettes would improve public health, according to a report from the FDA's Tobacco Products Scientific Advisory Committee (TPSAC).

The committee has been meeting for the past year to review medical literature, reports from FDA, tobacco company submissions, and public comments in order to determine the public health impact of adding menthol to cigarettes.

The panel released its recommendations on Friday, concluding that it is "biologically plausible" that adding menthol to cigarettes makes them more addictive and harder to quit and that companies that sell menthol cigarettes target minorities and kids with their advertising.

Although the report came down hard on the practice of adding menthol to cigarettes, it stopped short of recommending that the FDA order cigarette companies to stop selling menthol products.

The Family Smoking Prevention and Tobacco Control Act barred tobacco manufacturers from adding candy-like flavors to their products -- such as cloves and vanilla -- but the law left a determination on menthol to the FDA.

Menthol is an alcohol that stimulates cold receptors. Found naturally in peppermint and corn oil, it masks the harshness of cigarette smoke and provides a cooling effect.

But the panel said menthol is more than just a flavoring agent, because it has "drug‐like characteristics that modulate the effects of nicotine on the smoker." It provides a sensory stimulation referred to as the "throat grab" that could provide greater reinforcement of smoking behavior. When used in small doses, it reduces irritation caused by the nicotine in the cigarette smoke that could be appealing for novice smokers and makes it more likely they will become addicted, the panel members wrote in the report.

"The implications of these findings are that by reducing the harshness of tobacco smoke, menthol could facilitate initiation or early persistence of smoking by youth," the committee wrote in its report. "Also, by reducing the harshness of smoke, menthol could facilitate deeper and more prolonged inhalation of tobacco smoke, resulting in greater smoke intake per cigarette."

Studies on drug addiction have shown that sensory experiences can serve as stimuli that condition people to crave cigarettes once they've started smoking. For instance, once a person has started smoking menthol cigarettes, tasting menthol in toothpaste or food could trigger a craving, the report said.

In addition, the TPSAC report said some people are genetically more susceptible for becoming addicted to menthol cigarettes because of genetic differences in perceptions of taste.

About 19 million people in the U.S. smoke menthol cigarettes, which accounts for between 28% and 34% of all U.S. smokers. Overall, three in 10 adult smokers use menthol cigarettes.

Young Smokers Targeted

Adolescents 12 to 17 years smoke menthol cigarettes at a higher rate than any other age group, according to the TPSAC report. About half of middle school smokers and 45% of high school smokers said they usually smoke a menthol brand.

The panel said there is sufficient evidence to conclude that menthol cigarettes are marketed disproportionately to younger smokers by branding them as a more youthful product than nonmenthol cigarettes.

"The evidence shows based on concordant findings of the studies of internal tobacco industry documents, that tobacco companies were aware of the appeal of menthol cigarettes to younger, novice smokers because these cigarettes are easier to smoke," the report said.

Menthol Popular Among Minorities

Minority adolescents were more likely than white adolescents to smoke menthol cigarettes, the report found. Rates of menthol use were particularly high among black youths, ages 12 to 17.

More than 80% of adolescent African-American smokers use menthol cigarettes; more than half of adolescent Hispanic smokers and more than half of Asian-American middle school smokers use menthol cigarettes.

The issue of menthol in cigarettes is a racially charged one because tobacco companies have been accused of targeting African-Americans with their marketing. Three studies found that cigarette ads appearing in black-oriented publications such as Ebony were more likely to feature menthol cigarettes than ads in publications read mostly by whites, such as People. Also, one-third of all cigarette ads located in stores in predominantly black neighborhoods were for menthol products, compared with just 10% of cigarette ads in stores in predominately white areas.

The TPSAC confirmed that the prevalence of menthol cigarette smoking is highest among African Americans. While whites make up the numeric majority of menthol cigarette smokers, black smokers disproportionately favor the flavor: about 80% of black smokers choose menthol.

"All of the tobacco industry document reviews provide evidence that the tobacco industry developed specialized brands and tailored marketing strategies to promote menthol cigarettes to African Americans," the report said.

Menthol Makes It Easier to Get Hooked, Harder to Quit

Opponents of menthol in cigarettes have charged that the additive makes for a more appealing first-time cigarette experience than straight tobacco, making it more likely that a person who tried menthol cigarettes will continue to smoke.

There is only one unpublished analysis on whether menthol facilitates addiction in adolescents, but the panel said that study "strongly suggests" that it does (the same wasn't found for adult smokers).

In October, the panel heard from researchers who reviewed documents contained in the Legacy Tobacco Documents Library, a trove of more than 11 million individual documents obtained mostly through litigation and managed by the University of California San Francisco. Those documents included memo after memo indicating that cigarette makers believed that menthol cigarettes were more attractive to novice smokers -- in one case, calling them "good starter products."

There is evidence from national surveys that nonwhite smokers who smoke menthol cigarettes have more difficulty quitting than those who smoke nonmenthol cigarettes, the report said.

The report will now be reviewed by experts at the FDA Center for Tobacco Products. The FDA has no deadline by when it must act, but will provide a progress report on its review in 90 days, according to a statement from Lawrence Dayton, MD, director of the Center for Tobacco Products.

The FDA is not required to follow the advice of its advisory committees, but in the case of drugs and medical devices, it often does follow panel recommendations.