Tobacco Companies Pledge to Work With FDA on Menthol

Source from:  Tobacco Reporter 03/22/2011

R.J. Reynolds Tobacco Co said on Friday that it looked forward to continuing to talk with the Food and Drug Administration (FDA) as the agency began its review of the use of menthol in cigarettes. "The Agency now has input from the Tobacco Products Scientific Advisory Committee (TPSAC)*, tobacco manufacturers and industry representatives, and from the general public," said Jeffery S. Gentry, executive vice president of operations and chief scientific officer for R.J. Reynolds. [*The report is at http://tinyurl.com/5r4stye.] "As the director of the Center for Tobacco Products at FDA said in his remarks today, the TPSAC report does not set FDA policy and it does not set FDA actions. "It is information that the Agency will take into consideration in its analysis. "Several key issues, such as a potential increase in cigarette smuggling and contraband if menthol cigarettes were eliminated from the market, need additional study," Gentry added. "We continue to believe that any final decision by the agency should be based on sound science, and we look forward to continuing to provide information and our perspectives on this issue to the agency as it undertakes this process," he said. Meanwhile, Philip Morris USA said on Friday that it was reviewing the TPSAC's non-binding draft report on menthol cigarettes and looked forward to constructively working with the FDA as it continued its evaluation of this issue. "While today's [Friday's] report contains conclusions and recommendations, the report states, 'TPSAC is not proposing specific policy actions that should be taken by FDA'," PM USA said in a note placed on its website. "Moreover, the FDA reiterated this morning that the TPSAC report does not set FDA policy or FDA actions." "The FDA also emphasized that the Tobacco Control Act does not set a required deadline or timeline for the FDA to act on the recommendations in the report, and that receipt of the TPSAC report will not have a direct, immediate effect on the availability of menthol cigarettes." "In addition, the report recognized that the potential for contraband menthol cigarettes and other unintended consequences exists and recommends that the FDA consults with appropriate experts on this issue." "PM USA plans to submit its report to the FDA discussing the science-and evidence-based information concerning menthol cigarettes by March 23, 2011." Enditem