U.S. judge tosses FDA panel report on menthol cigarettes

NEW YORK, July 21 Mon Jul 21, 2014 8:11pm EDT

NEW YORK, July 21 (Reuters) - A federal judge ruled on Monday in favor of two tobacco companies that challenged a 2011 U.S. Food and Drug Administration committee report on menthol cigarettes, finding three of the panel's members had conflicts of interests.

U.S. District Court Judge Richard Leon ordered the FDA reconstitute the committee and barred the agency from using the panel's findings, which said removing menthol cigarettes from the market would benefit public health.

Lorillard Inc and Reynolds American Inc's R.J. Reynolds Tobacco Co unit filed the lawsuit in 2011 arguing the panel's members were biased against the industry. Three of the panel's expert doctors had worked for lawyers suing tobacco manufacturers, the opinion said. There were eight voting members serving on the committee at the time the lawsuit was filed, according to the original complaint.

"The presence of conflicted members on the Committee irrevocably tainted its very composition and its work product," Leon wrote in ruling filed at the U.S. District Court in Washington, D.C.

He called the panel's findings and recommendations "at a minimum suspect, and, at worst, untrustworthy."

Leon has sided with the tobacco companies in the past. In February 2012, he struck down the FDA's requirement that cigarette packaging carry large, graphic warnings about the dangers of smoking.

In March 2013 the FDA gave up trying to require such warnings, showing rotting teeth, diseased lungs and other images.

Reynolds American has proposed a $25 billion acquisition of smaller rival Lorillard Inc in a move that signals the industry is betting on the continued growth of menthol sales. Lorillard makes the Newport brand of mentholated cigarettes.

The companies were not immediately available to comment on the ruling. FDA spokeswoman Stephanie Yao said the agency did not yet have a comment.

The case is Lorillard Inc et al v. United States Food And Drug Administration et al, in the U.S. District Court District of Columbia, No. 1:11-cv-00440-RJL (Additional reporting by Jonathan Stempel; Editing by Mohammad Zargham)

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