Where's FDA on Menthol?
A year after TPSAC, retail industry still waits for FDA's final word on menthol cigarettes
WASHINGTON -- A year has passed since a U.S. Food & Drug Administration (FDA) tobacco advisory committee issued a report on menthol cigarettes--and still no action from the final federal decision makers.
A March 18, 2011, report by the Tobacco Product Scientific Advisory Committee (TPSAC) recommended that "removal of menthol cigarettes from the marketplace would benefit public health in the United States."
At the time, Dr. Lawrence Deyton, director of FDA's Center for Tobacco Products (CTP), underscored that TPSAC's recommendation was just that, and that future action by the FDA concerning sale and distribution of menthol cigarettes would be determined based on multiple factors, including input from retail groups.
To the surprise of many, Deyton has yet to issue a decision. And according to some, the extensive delay has become the butt of jokes and doubts about the FDA's ability to truly oversee the complex tobacco industry.
This was the headline and subhead of Deutsche Bank's tobacco note from analyst Christina McGlone: "Tobacco: Where things stand on menthol …. Still waiting… Regulatory vacuum remains a sector overhang."
McGlone noted the steady flow of questions from investors concerning menthol and said, "FDA's pending and overdue science assessment remains [the] biggest potential source of near-term stock volatility."
Like other analysts, she cast doubt that the FDA will issue an outright ban of menthol smokes, pointing out, "While worst-case is move towards a ban, our best estimate remains a negatively worded report on underage, but delayed action in favor of further studies."
An FDA study released earlier this month is giving hope that a decision may be nearing on menthol and it will be one the retail and tobacco manufacturing industry can embrace.
An FDA scientist found a lower risk of dying from lung cancer among menthol smokers compared to nonmenthol smokers at age 50 and over, the Winston-Salem Journal reported last week. The scientist, Brian Rostron of the FDA's CTP, studied data of 6,074 smokers from 1987 to 2006, including 1,417 who smoked only menthol cigarettes.
The lower risk of dying from lung cancer was found in all age groups, in men and women, and with black smokers compared with white smokers.