WASHINGTON -- In a lawsuit filed jointly by Lorillard and R.J. Reynolds Tobacco Co. in the U.S. District Court for the District of Columbia on Friday, the tobacco companies allege conflicts of interest and bias among members of the U.S. Food & Drug Administration's Tobacco Products Scientific Advisory Committee (TPSAC). The suit seeks to stop the FDA from receiving or relying on recommendations from the committee, including recommendations regarding the use of menthol in cigarettes.
In the complaint, Lorillard also asks the court to enjoin the FDA from making available [image-nocss] to the advisory committee any trade secret or confidential commercial documents submitted by the company to FDA until the advisory committee is lawfully constituted.
The committee is expected to submit a nonbinding recommendation on the use of menthol in cigarettes to the FDA by March 23, 2011.
"As a matter of general policy, the FDA does not comment on possible, pending or ongoing litigation," Kara Henschel of the FDA Center for Tobacco Products, told CSP Daily News
The suit alleges that the TPSAC 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 acted 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. These companies stand to potentially benefit from future FDA actions based on advice and recommendations from the TPSAC, the companies said.
Beginning last year, the two companies and others urged the FDA to ensure that members of the panel were free of 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 impartiality," said Ronald S. Milstein, senior vice president and general counsel of Lorillard, in a statement.
"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, executive vice president and general counsel for Reynolds said in a statement. "The FDA has not provided a response to the specific arguments presented in our letters. We believe the only way now to have our concerns taken seriously is through the courts."
Additionally, the Federal Advisory Committee Act requires that the TPSAC be "fairly balanced in terms of the points of view represented." The Committee lacks fair balance on many topics, including a role for dissolvable and other smokeless tobacco products in tobacco harm reduction, said Reynolds. That issue divides the public-health and tobacco-control communities.
"Four of the eight members of the committee have publicly opposed a current role for smokeless products in tobacco harm reduction," Holton said. "No one on the committee represents the opposing view in the public health and tobacco-control communities. It's apparent that the committee is not fairly balanced."
Lorillard holds about 35% of the U.S menthol market with its Newport brand, said the Associated Press. 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, AP added, saying scientific evidence does not show that menthol cigarettes create greater health risk than nonmenthol cigarettes. Lorillard also has said it believes that a ban on menthol would lead to a black market for contraband smokes.
Winston-Salem, N.C.-based R.J. Reynolds is the second-largest U.S. tobacco company. The company's brands include five of the 10 best-selling U.S. cigarettes: Camel, Pall Mall, Winston, Doral and Kool. American Snuff (formerly Conwood Co.) is the nation's second-largest manufacturer of smokeless tobacco products. Its leading brands are Kodiak, Grizzly and Levi Garrett. Santa Fe manufactures Natural American Spirit cigarettes and other additive-free tobacco products, and manages and markets other super-premium brands. Niconovum markets nicotine replacement therapy products in Sweden and Denmark under the Zonnic brand name.
Lorillard is the third largest manufacturer of cigarettes in the United States. Newport, Lorillard's flagship menthol-flavored premium cigarette brand, is the top-selling menthol and second-largest-selling cigarette in the United States. In addition to Newport, the Lorillard product line has four additional brand families marketed under the Kent, True, Maverick and Old Gold brand names. These five brands include 43 different product offerings which vary in price, taste, flavor, length and packaging. Lorillard maintains its headquarters and manufactures all of its products in Greensboro, N.C.
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