Appeals Panel Rules in Favor of Controversial FDA Menthol Report
WASHINGTON, D.C. — The Food and Drug Administration (FDA) has scored a legal victory over its 2011 menthol report.
According to The Associated Press, a federal appeals court ruled that tobacco companies had no basis to challenge the FDA report on menthol cigarettes, which the industry alleged was written by experts with conflicts of interest.
The decision by a three-judge panel overturns a lower court ruling that barred the FDA from using the report and ordered the agency to reform its committee of tobacco advisers.
The FDA's Tobacco Product Scientific Advisory Committee (TPSAC) 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.
Reynolds American Inc. (RAI) and Lorillard 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. At the time, Lorillard was the maker of Newport, a top-selling menthol cigarette brand in the United States. The cigarette manufacturer has since been acquired by RAI.
On July 21, 2014, U.S. District Court Judge Richard Leon in Washington, D.C., barred the agency from using the report and also ordered the FDA to reconstitute the tobacco panel.
In this latest ruling, however, Judge Stephen Williams, writing for the court, stated that the tobacco companies had no legal basis to challenge the makeup of the committee. Williams rejected the companies' arguments that they could be damaged by the apparent conflicts as "too remote and uncertain," the AP reported.
The opinion was issued Friday in the U.S. Court of Appeals for the Federal Circuit.
RAI declined to comment on pending litigation when reached Friday afternoon by CSNews Online.
Despite the victory for the federal government, the ruling may have limited impact on the FDA or its advisory panel. Last year, the FDA announced that four members of its tobacco products advisory panel had either resigned or were removed, following the previous court ruling against the agency.
In 2013, the FDA conducted its own review of menthol cigarettes, concluding they pose a greater public health risk than regular cigarettes. But it did not make a recommendation on whether to limit or ban them.