Judge Calls FDA Report on Menthol Cigarettes “Tainted”

Ruling finds conflicts of interest in FDA menthol review board panel’s findings.

July 23, 2014

WASHINGTON – A federal judge has ruled in favor of two tobacco companies that challenged a 2011 U.S. Food and Drug Administration committee report on menthol cigarettes, finding that three of the panel's members had conflicts of interests.

U.S. District Court Judge Richard Leon ordered the FDA to assemble a new Tobacco Products Scientific Advisory Committee (TPSAC) and barred the agency from using the panel's findings, which said removing menthol cigarettes from the market would benefit public health, describing the report as “tainted.”

“NACS will continue to work with a newly constituted TPSAC to highlight the danger of increased black market activity should menthol cigarette availability be curtailed in any way,” said Lyle Beckwith, NACS senior vice president of government relations, upon learning of the ruling.

Lorillard Inc. and R.J. Reynolds Tobacco Company filed the lawsuit (Lorillard Inc et al v. United States Food And Drug Administration et al) in 2011, alleging that three of the 12 members of the advisory panel had conflicts of interest which biased them against the tobacco industry. In his ruling, Leon cited the doctors’ work as consultants to the pharmaceutical industry regarding tobacco cessation products and their roles as paid expert witnesses in litigation against tobacco product manufacturers.

“The presence of conflicted members on the committee irrevocably tainted its very composition and its work product,” the judge said in his decision. He added that the findings that menthol cigarettes harm public health are “at a minimum, suspect, and at worst, untrustworthy.”

According to news reports, FDA spokeswoman Stephanie Yao said the agency was reviewing the decision to determine how to proceed.

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