However, Lawrence R. Deyton, director of the Center for Tobacco Products, has been adamantthat the recommendation "is simply that--a committee recommendation based on its review of current, prevailing science on the topic of menthol as an ingredient in cigarettes."[image-nocss]
He added in a statement this past week, "With a thorough review of the report and recommendations pending, it is important to note that FDA's receipt of the final report does not have a direct or immediate effect on the availability of menthol products in the marketplace."
In addition to TPSAC's overall recommendation, the report alsolooked at the potential of a menthol black market, as it pertains to public health. "TPSAC acknowledges that the potential for contraband menthol cigarettes exists, should FDA choose to implement a ban or take some other policy action that restricts availability of menthol cigarettes." The report recommended that the FDA consult with experts and carry out relevant analyses on that issue.
See a related story elsewhere in this issue of CSP Daily News for testimony on the menthol issue from AWMA president and CEO Scott Ramminger.
The FDA's review of menthol cigarettes and other tobacco products was initiated by the approval and signing of the Family Smoking Prevention and Tobacco Control Act.
The draft recommendation further states: "Consistent with the requirements of the act, TPSAC recommends that FDA consult with appropriate experts and carry out relevant analyses depending on the actions taken in response to this report from TPSAC."
There is no required deadline or timeline for FDA to act on the issue of menthol in cigarettes. However, Deyton said, "We recognize the strong interest in this issue among all stakeholders and will continue to communicate the steps the FDA is taking as it determines what future regulatory actions, if any, are warranted." He added that FDA intends to provide its first progress report on the review of the TPSAC recommendations in approximately 90 days.
The final report from TPSAC with recommendations on menthol is scheduled to be issued this Wednesday, March 23rd, 2011.
In a recent CSP Tobacco Cyberconference, Nik Modi, tobacco analyst, UBS Securities LLC, New York, said there is prededent for the FDA to decide against a panel recommendation, citing six examplesall of them related to drug approvals or reinstatements.
With the release of TPCAS's draft recommendation, the largest menthol-cigarette manufacturer in the country is keeping a close eye on the FDA's decision process. Menthol accounts for about 90% of Lorillard Inc.'s business. (Altria Group Inc. and Reynolds American Inc. also sell menthol cigarettes, but have a more diversified offering.)
Murray S. Kessler, CEO of Lorillard, said in a statement: "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.
"More 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 hereto read "Menthol Cigarettes and Public Health: Review of the Scientific Evidence and Recommendations."
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