Lorillard and Reynolds Sue to Halt Regulation Based on Upcoming Report on Menthol Cigarettes

Unsurprisingly, Lorillard, Inc. and Reynolds American, Inc.'s R.J. Reynolds Tobacco Company unit filed suit against FDA regarding an upcoming advisory panel board that will likely recommend a ban on menthol cigarettes.  Lorillard's top seller is the Newport brand and Reynolds sells, among other things, several mentholated versions of its Camel brand cigarettes.  FDA, of course, gained the power to regulate the tobacco industry in 2009 with the passage of the Family Smoking Prevention and Control Act.  Shortly thereafter, on September 22, 2009, FDA banned flavored cigarettes, with a particular eye towards vanilla, chocolate and clove cigarettes.  The ban of the latter raised some interesting WTO issues, but more importantly for our purposes, set the stage for the current controversy.
Although few know exactly what the upcoming Tobacco Products Scientific Advisory Committee (TPSAC) report on menthol cigarettes contains, many expect that the committee will call for an outright ban.  The report is due to be released on March 23, 2011, and in advance of its release, TPSAC will meet twice more in early to mid-March.  Following the report's release, FDA will consider the report and take whatever action it deems appropriate.  With a ban both legally allowable and likely imminent, manufacturers of menthol cigarettes have no choice but to take action to protect their business interests.
In their Complaint, filed in the United States District Court for the District of Columbia, Lorillard and Reynolds have requested the Court to enter declaratory and injunctive relief requiring the defendants to bring TPSAC and the membership of the constituents subcommittee of TPSAC into compliance with the law and to prevent FDA from taking any action based on or influenced by or from making any use of any report provided by TPSAC or the constituents subcommittee as currently constituted.  Specifically, the plaintiffs allege that three of the eight voting members of TPSAC have financial and appearance conflicts of interest and biases that are incompatible with TPSAC's roles as an impartial advisor to FDA.  Substantively, the plaintiffs allege that those three members of TPSAC cannot act objectively because they have all either appeared as paid expert witnesses in litigation against tobacco-product manufacturers or are or have been employed by members of the pharmaceutical industry engaged in the production of nicotine replacement therapy or other smoking cessation products.
While it remains to be seen whether this suit has any merit, at the least, it's sure to impede any further regulation of flavored cigarettes by FDA.  We'll keep our eye on this and do our best to keep you up to date.


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