Two of the nation's largest cigarette makers on Friday asked a federal court to stop the Food and Drug Administration from relying on recommendations made by an advisory panel on issues such as menthol cigarettes.
In the suit filed in U.S. District Court in Washington, Lorillard Inc. and R.J. Reynolds Tobacco Co. allege financial conflict of interest and bias by several members of the Tobacco Products Scientific Advisory Committee.
The panel, which is tasked with advising the agency on various tobacco-related issues, is set to release a report in March on the public health impact of menthol cigarettes, a key area for growth for tobacco companies in a shrinking cigarette market.
The FDA won the authority to regulate tobacco in June 2009. The law doesn't let the FDA ban nicotine or tobacco, just regulate what goes into tobacco products, require the ingredients be publicized and limit how tobacco is marketed, especially to young people. The agency's panels advise it on scientific issues. It doesn't have to follow their recommendations, but usually does.
According to the suit, on issues relating both to menthol in cigarettes and smokeless tobacco products, the panel fails to meet the federal requirements that committee members should be fairly balanced and not inappropriately influenced by any special interest.
The suit specifically alleges that three committee members have conflicts of interest because they were paid expert witnesses in anti-tobacco lawsuits and have financial ties to pharmaceutical companies that make smoking-cessation products.
"There will be no way for the defendants or the public to have confidence that the Committee's report and recommendations with respect to menthol are the product of an unbiased assessment of the relevant science, uninfluenced by special interests and by the prospect of financial gains," according to the suit.
FDA spokesman Jeff Ventura said the agency does not comment on pending litigation.
Several cigarette makers, including Altria Group Inc., parent company of Philip Morris USA, had previously asked the federal agency to remove members of the panel for conflicts of interest. Altria Group is not part of the suit filed Friday.
Lorillard, based in Greensboro, N.C., holds about 35 percent of the U.S menthol market with its top-selling Newport brand. R.J. Reynolds and its parent company, Reynolds American Inc., based in Winston-Salem, N.C., sell brands like Camel and Pall Mall.
Opponents say the minty flavor of menthol cigarettes can entice young people to start smoking and may make it harder to quit. They are also disproportionately smoked by African-American smokers.
U.S. cigarette makers have gone on the offensive amid the menthol review, saying scientific evidence does not show that menthol cigarettes create greater health risk than non-menthol cigarettes. Lorillard also has said it believes that a ban on menthol would lead to a black market for contraband smokes.