Richmond, Va.-based Philip Morris USA said:
"Philip Morris USA is reviewing the Tobacco Products Scientific Advisory Committee's (TPSAC) nonbinding draft report on menthol cigarettes and looks forward to constructively working with the FDA as it continues its evaluation of this issue.
"While [the] report contains conclusions and recommendations, the report states, 'TPSAC is not proposing specific policy actions that should be taken by FDA.' Moreover, the FDA reiterated...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."
PM USA's cigarette product portfolio is led by Marlboro. Its other cigarette brands include Parliament, Virginia Slims, Basic and L&M. PM USA also manufactures and markets Marlboro Snus, a spit-free, tobacco pouch product designed for adult smokers who are interested in smokeless tobacco alternatives to cigarettes. PM USA is a wholly-owned subsidiary of Altria Group Inc.
Winston-Salem, N.C.-based R.J. Reynolds Tobacco Co. said that "it looks forward to continuing to dialogue with the [FDA] as the agency begins its review of the use of menthol in cigarettes."
"The agency now has input from the [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. "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 said. "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.
An indirect subsidiary of Winston-Salem, N.C.-based Reynolds American Inc., R.J. Reynolds Tobacco's U.S. cigarette brands include Camel, Pall Mall, Winston, Kool, Doral and Salem.
And as reported yesterday in CSP Daily News, Greensboro, N.C.-based Lorillard Inc. said:
"While we fundamentally disagree, we are not surprised by what we believe is TPSAC's unsubstantiated conclusion relative to the impact of menthol cigarettes on public health," said Murray S. Kessler, chairman, president and CEO of Lorillard. "Most importantly, TPSAC's report is just the first step in what we believe will be a very long process that ultimately does not result in the removal of menthol cigarettes from the marketplace, especially when contraband and other unintended consequences are seriously considered."
(Click here for previous CSP Daily News coverage.)
"In [the] meeting, Dr. Lawrence Deyton, director of FDA's Center for Tobacco Products, stated that TPSAC's recommendation is simply advice and does not set FDA policy or action and that the FDA would conduct its own review. The advisory committee recommendation is not binding and the FDA is not obligated to take any regulatory action whatsoever.
"The company believes that as the FDA conducts their own assessment of menthol, they will follow a rigorous scientific evaluation that will come to the same conclusion as the Industry Report on Menthol. The Industry Report clearly demonstrates that a menthol cigarette is no more dangerous than a nonmenthol cigarette and should be regulated no differently and further, that the countervailing effects of any restriction in availability would overwhelm any potential public health benefit. The Industry Report will be formally submitted to the FDA by their deadline of March 23, 2011."
"The Industry Menthol Report" was submitted to the FDA at its request by the nonvoting tobacco industry representatives on TPSAC and other tobacco industry stakeholders. Industry scientists with many decades of knowledge and experience in research involving tobacco, cigarettes and menthol have prepared this report after reviewing the best available data on the use of menthol in cigarettes. These scientists include leaders in their fields, recognized worldwide as experts for their published research investigating menthol and other constituents, as well as smoking and health issues.
Its major conclusions: Smoking prevalence is declining overall, nonmenthol cigarettes are preferred by most smokers, and menthol cigarettes are preferred by some subgroups of smokers. Menthol does not change the inherent health risks of cigarette smoking. Menthol in cigarettes has no meaningful effect on smoking biomarkers. Evidence on menthol and smoking topography is mixed; evidence does not support a conclusion that menthol cigarettes are smoked more intensely. Menthol does not meaningfully alter the chemical composition of mainstream smoke. Evidence is inadequate to conclude that menthol influences smoking initiation. Menthol has no meaningful impact on smoking cessation. Menthol has no meaningful impact on nicotine dependence. Numerous hypotheses put forth by TPSAC are speculative and cannot serve as the basis for regulatory policy. A ban on menthol will result in significant countervailing effects [including a black market]. Click hereto read the draft executive summary of "The Industry Menthol Report."Newport, Lorillard's flagship menthol-flavored premium cigarette brand, is the top-selling menthol and second largest selling cigarette in the United States. In addition to Newport, the Lorillard product line has four additional brand families marketed under the Kent, True, Maverick and Old Gold brand names.
And click here to readTPSAC's report, "Menthol Cigarettes & Public Health: Review of the Scientific Evidence & Recommendations."
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