FDA Barred From Using Menthol Report

RICHMOND, Va. -- Three years after an advisory panel to the Food and Drug Administration (FDA) issued its report on menthol in cigarettes, a federal judge has barred the agency from using the report.

On July 21, U.S. District Court Judge Richard Leon in Washington, D.C., also ordered the FDA to reconstitute the tobacco panel.

The ruling affects the report by the FDA's Tobacco Product Scientific Advisory Committee (TPSAC), which issued its menthol findings in March 2011. TPSAC in its report recommended that removing menthol cigarettes from the market would benefit public health, as CSNews Online previously reported.

While the agency has since conducted an independent review on the public health impact of menthol cigarettes, Leon's ruling could hinder the FDA's ability to defend any future regulation of menthol cigarettes, according to The Associated Press.

Greensboro, N.C.-based Lorillard Inc. and Winston-Salem, N.C.-based Reynolds American Inc. sued the agency in 2011, alleging conflicts of interest and bias by several members of the panel tasked with advising the FDA on tobacco-related issues, the news agency reported.

Lorillard is the maker of Newport, a top-selling menthol cigarette brand in the United States.

The tobacco companies argued that TPSAC failed to meet the federal requirements that committee members should be fairly balanced and not inappropriately influenced by any special interest. The lawsuit specifically alleged that some committee members had conflicts of interest because they served as paid expert witnesses in anti-tobacco lawsuits and had financial ties to pharmaceutical companies that make smoking-cessation products.

However, the FDA argued that the panel met federal standards and that the cigarette makers' "alleged injuries are entirely speculative."

In his order released earlier this week, Leon said the FDA erred in determining that the members didn't have conflicts of interest and therefore, the agency's appointment of those members was "arbitrary and capricious," and tainted both the panel and its work, according to the AP report.

"Conflicts of interest -- whether actual or perceived -- undermine the public's confidence in the agency's decision-making process and render its final product suspect, at best," the judge wrote.

Jonathan Samet is the only remaining member of TPSAC challenged in the lawsuit. Samet, director of the University of Southern California's Institute for Global Health and former director of the Institute for Global Tobacco Control at Johns Hopkins University, serves as the panel's chair. He did not immediately respond to an AP request seeking comment.

Reynolds applauded the judge's ruling. "We are pleased with the result and the confirmation by the court that the rights and protections of the law afforded other companies apply to tobacco companies as well," said David Howard, a spokesman for R.J. Reynolds Tobacco Co.

Representatives with the FDA and Lorillard did not immediately provide comment to the AP following the ruling.