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GREENSBORO, N.C. -- Four weeks ahead of a non-binding recommendation on the use of menthol, Lorillard Inc. filed suit to stop the Food and Drug Administration from receiving or relying on recommendations it may receive from its scientific advisory committee.
Lorillard, the maker of popular menthol cigarette brand Newport, and R.J. Reynolds jointly filed the legal move in U.S. District Court for the District of Columbia on Friday, Feb. 25. The FDA's Tobacco Products Scientific Advisory Committee is expected to deliver is recommendation on the use of menthol -- which could include a possible ban -- on March 23.
In the complaint, Lorillard also asks the court to enjoin the FDA from making available to the advisory committee and trade secret or confidential commercial documents submitted by the company to the FDA until the advisory committee is lawfully constituted, according to a release by the locally headquartered Lorillard.
According to Lorillard, the suit alleges that the Tobacco Products Scientific Advisory Committee as currently constituted fails to meet requirements of the Federal Advisory Committee Act to be fairly balanced and not to be inappropriately influenced by any special interest. Instead, the suit alleges, conflicts of several members of the committee render the panel unable to deliver any report or recommendation to the FDA that is "free of the taint of conflicts of interest."
The suit specifically alleges that three members of the committee, Drs. Neil Benowitz, Jack E. Henningfield and Jonathan M. Samet are conflicted because they have made tens of thousands of dollars as paid expert witnesses in litigation against tobacco products manufacturers and due to their continuing financial relationships with pharmaceutical companies that make smoking-cessation products.
The release further states that both Lorillard and R.J. Reynolds, along with others, have urged the FDA to ensure that the members of the panel did not have any conflicts. "We are taking this action reluctantly after the FDA failed to constitute the committee in accordance with the law and failed to properly address legitimate concerns regarding fairness and impartially," said Ronald S. Milstein, senior vice president and general counsel of Lorillard.
The FDA has declined to comment on this suit. "As a matter of general policy, the FDA does not comment on possible, pending or ongoing litigation," said Kara Henschel with the FDA.