Appeals Court Reinstates FDA's Menthol Report

Disagrees with lower court that TPSAC members had conflicts of interest

menthol

WASHINGTON -- The U.S. Court of Appeals for the D.C. Circuit upheld the right of the U.S. Food & Drug Administration (FDA) to use a report written by an advisory committee that concluded menthol cigarettes pose a greater public health risk than non-menthol cigarettes, reported Reuters.

The court's ruling overturned an order by District Court Judge Richard Leon's that the report be barred from use.

In 2014, Leon had ruled in favor of the tobacco companies Reynolds American Inc. and Lorillard Inc. (the two companies have since merged) who had argued that three members of the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) had conflicts of interest because they had acted as expert witnesses in lawsuits against tobacco manufacturers or consulted for drug companies making smoking-cessation drugs.

The tobacco companies had argued that the FDA's appointment of those panel members increased the risk that the FDA would regulate menthol tobacco products in a way that would hurt their interests.

They also argued that the committee members would have access to confidential company information that they could use against them; and that they could shape the menthol report to generate more expert witness business.

Leon ordered the FDA to reconstitute the committee to exclude the allegedly conflicted members and barred the agency from using the report for regulatory purposes.

The report found that while menthol cigarettes, which account for about a quarter of all cigarettes sold in the United States, are no more or less toxic than regular cigarettes, menthol's cooling and anesthetic properties reduce the harshness of cigarette smoke, increasing their appeal to new smokers.

Judge Stephen Williams, writing on behalf of the U.S. Court of Appeals for the D.C. Circuit, said that the plaintiffs lack standing because they must show an injury that is "actual or imminent, not conjectural or hypothetical" and that all three of their cited injuries did not meet that test.

"We conclude that all three are too remote and uncertain, or, to put the same thing another way, insufficiently imminent," he wrote.

Winston-Salem, N.C.-based Reynolds American declined to comment on the ruling, citing pending litigation, Jacob McConnico, as spokesperson for R.J. Reynolds Tobacco Co., told CSP Daily News.

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