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Tobacco companies file lawsuit against FDA advisory panel

By Carrie Schimizzi

[JURIST] Two tobacco companies filed a lawsuit [press release] in the US District Court for the District of Columbia [official website] on Friday against the Food and Drug Administration (FDA) [official website] in order to enjoin a recent opinion by the agency's advisory committee due to conflicts of interest. The suit, filed by Lorillard, Inc. and R.J. Reynolds Tobacco Company [corporate websites] seeks to prevent the FDA from relying on a forthcoming recommendation on the use of menthol in cigarettes [Reuters report]. The suit alleges that three members of the Tobacco Products Scientific Advisory Committee [official website], Doctors Neil Benowitz, Jack Henningfield and Jonathan Samet, have made thousands of dollars as expert witnesses in litigation against tobacco product manufacturers and have "continuing financial relationships" with pharmaceutical companies that make smoking-cessation products. The FDA is not required to comply with the advisory committee's recommendation, but the tobacco companies fear any ban on menthol cigarettes. The recommendation is expected to be released by March 23, 2011.

Just last year, the FDA announced [press release] a final rule [text] restricting tobacco sales and promotions [JURIST report] directed at youth. The Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents are a set of broad regulations "designed to significantly curb access to and the appeal of cigarettes and smokeless tobacco products to children and adolescents in the United States." In 2009, US President Barack Obama [official website] signed into law [JURIST report] the Family Smoking and Tobacco Prevention Act [HR 1256 text], which grants the FDA certain authority to regulate tobacco products. The legislation heightens warning-label requirements, prohibits marketing "light cigarettes" as a healthier alternative, and allows for the regulation of cigarette ingredients. Under the bill, the FDA has the authority to regulate tobacco products but does not permit the agency to regulate tobacco leaf that is not in the hands of tobacco product manufacturers or producers of tobacco leaf, including tobacco growers, tobacco warehouses, or tobacco grower cooperatives. The FDA first began to regulate the tobacco industry in 1996, but, in 2000 the US Supreme Court ruled in FDA v. Brown & Williamson Tobacco Corp. [opinion text] that Congress had not provided the FDA with the authority to regulate tobacco products.

Full post as published by JURIST - The Paper Chase on February 27, 2011 (boomark / email).