Cigarette Makers Sue FDA Over Review

The suit alleges a financial conflict of interest and bias by several members of the Tobacco Products Scientific Advisory Committee.

March 01, 2011

WASHINGTON - Lorillard Inc. and R.J. Reynolds Tobacco Co. last week asked a federal court to stop the Food and Drug Administration (FDA) from relying on advisory panel recommendations on issues such as menthol cigarettes, the Associated Press reports.

Filed in the U.S. District Court in Washington, the suit alleges financial conflict of interest and bias by several members of the Tobacco Products Scientific Advisory Committee (TPSAC).

The TPSAC is responsible for advising the FDA on tobacco-related issues and is expected to release a report later this month on the health impact of menthol cigarettes, a key growth area for tobacco companies.

While the FDA assumed the authority to regulated tobacco in June 2009, the law doesn??t allow the agency to ban nicotine or tobacco, only to regulate what goes into the products as well as to regulate how they??re marketed. As such, it relies on advisory panels to address scientific issues. While the agency isn??t required to follow their recommendations, it usually does.

The lawsuit claims on issues regarding menthol in cigarettes and smokeless tobacco that the TPSAC fails to meet federal requirements that committee members be fairly balanced and not inappropriately influenced by special interests.

The suit 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 produce 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," the suit reads.

Several cigarette makers had previously asked the FDA to remove members of the panel for conflicts of interest.

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