UPDATE: Lorillard, RJ Reynolds Sue FDA Over Menthol Review Panel

Two major tobacco firms filed a lawsuit against the Food and Drug Administration Friday over the agency's review of menthol cigarettes, claiming some members of an FDA panel have conflicts of interest.

Specifically, Lorillard, Inc. (LO) and R.J. Reynolds, part of Reynolds American Inc. (RAI), have sued to stop the agency from receiving or relying on recommendations from its tobacco products advisory committee.

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. The suit alleges that several members of the panel have conflicts of interest.

FDA spokesman Jeffrey Ventura said the agency has a policy of not commenting on possible or ongoing litigation.

The Food and Drug Administration was given the authority to regulate tobacco products in 2009. As part of the tobacco law, all tobacco flavorings except for menthol were banned on concerns the flavors enticed children and adolescents to start smoking.

The FDA is currently considering what, if anything, to do about menthol and has charged its tobacco products scientific advisory committee with writing a report about the public health impact of menthol. The panel report is due March 23. It's not clear if the report will contain specific recommendations about whether menthol should be banned. Even if the report were to recommended a menthol ban or some other restriction the FDA would make a final decision. The agency has said there is no timeline.

Lorillard said it has pressed the FDA to ensure that members of the panel were free of conflicts but that the concerns have been ignored.

"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 impartiality," said Ronald S. Milstein, senior vice president and general counsel of Lorillard.

Menthol cigarettes account for about 30% of total cigarette sales in the U.S. The issue is of major importance to Lorillard, the maker of the leading menthol brand, Newport. The product accounts for roughly 90% of the company's sales

"Over the past eight months, R.J. Reynolds Tobacco Co. has sent the FDA seven letters raising concerns about conflicts of interest among several members of the Tobacco Products Scientific Advisory Committee," said Martin L. Holton III, the company's executive vice president and general counsel. "We believe the only way now to have our concerns taken seriously is through the courts."

Reynolds said the letters explain that three committee members have direct financial conflicts stemming from both their paid expert testimony in tobacco-products litigation and from their compensation from pharmaceutical companies that market nicotine-replacement and smoking-cessation products.

One question the FDA tobacco panel is weighing is whether menthol masks the harshness of tobacco and makes it easier to smoke cigarettes and harder to quit.

The tobacco industry has said there's no evidence that menthol cigarettes, compared with regular brands, make it more likely people will start smoking. Another question the panel is considering is whether there's an increased risk for disease among menthol smokers compared with those using regular-flavored cigarettes.

-By Jennifer Corbett Dooren, Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

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