FDA CTP SAC - 2nd Meeting - July 15, 16, 2010 plus....

July 27, 2010 - U.S. Food & Drug Administration (FDA) commissioner Margaret Hamburg made headlines last week when she told an FDA tobacco products scientific advisory committee (TPSAC) panel to "follow the science wherever it leads and the rest will fall into place." With Hamburg's words on the screen beside him, a Lorillard Tobacco Co. scientist on Friday called upon the FDA's TPSAC to employ a "truly science-based, data-driven" process in its evaluation of menthol in cigarettes.

TPSAC held meetings on July 15 and July 16. It heard industry presentations on how menthol is used in cigarettes, health effects, marketing efforts and impacts on specific groups of people.

View the full meeting agenda..

NOTE: The original agenda had been changed. On July 15th the committee was suppose to hear and discuss a presentation on dissolvable tobacco products. (FDA CTP - July 15-16, 2010 - next meeting of scientific advisory committee..)

View the webcast for meetings on July 15th and July 15th..

View TPSAC materials, including a committee roster and statements submitted by Richmond, Va.-based Altria Client Services (Phillip Morris USA), Greensboro, N.C.-based Lorillard and Winston-Salem, N.C.-based R.J. Reynolds Tobacco Co.

FDA CTP Scientific Advisory Committee Meeting outcome - committee wants more industry data on menthol..

Lorillard representatives keep on stating that, "TPSAC should ground its principles and analysis in sound science...An objective analysis of the science surrounding menthol shows that menthol does not increase the health risks of cigarette smoking and that menthol cigarettes do not play a unique role in starting smoking, stopping smoking or in smoking dependence. The evidence is pretty strong that menthol cigarettes do play a role in starting smoking and trying to stop smoking. Menthols are now as high as 35 percent of cigarette sales in the U.S.A. and growing.

Following the FDA advisory meeting, Credit Suisse said last week that Lorillard is not as weak as it thought. "It appears that the FDA will create a report sub-committee to draft the final recommendation before a full committee vote on it but we do not know yet, if the draft will be developed publicly. Independent of the recommendation we still do not believe that the FDA would ultimately ban menthol," the brokerage said. The final menthol recommendation is expected in March 2011.

Legislation signed into law last year authorized the FDA to regulate cigarettes and other tobacco products. One provision of the law mandated the creation of TPSAC, which will submit a report and recommendation on the use of menthol in cigarettes to the FDA.

References: FDA Menthol Replay Watch the Tobacco Products Scientific Advisory Committee meeting, Convenience Store/Petroleum (CSP) Daily News, 7/20/2010; Lorillard To Report Q2 Results: Earnings Preview, RTT News, 7/26/2010.