On July 21, 2014, Judge Richard Leon of the United States District Court for the District of Columbia ruled that the Food and Drug Administration (“FDA”) was barred from considering a 2011 report that recommended the removal of menthol cigarettes from the marketplace (the “Menthol Report”), because the advisory committee that prepared the report was tainted by conflicts of interest.
The lawsuit, which was filed by Lorillard and R.J. Reynolds, challenged the Menthol Report on the grounds that several members of the FDA’s Tobacco Products Scientific Advisory Committee (“TPSAC”), who had helped author the report, had conflicts of interest.
The challenged TPSAC members had served as expert witnesses for plaintiffs in lawsuits against tobacco companies and as consultants for manufacturers of products intended to help smokers quit smoking. This created both an actual financial conflict of interest for the TPSAC members and the appearance of a conflict of interest to the public.
Judge Leon’s strongly-worded opinion rebuffed the FDA’s contention that the challenged TPSAC members had no incentive to recommend banning or restricting menthol cigarettes. “Please!” the judge wrote, “This conclusion defies common sense.”
The court pointed out that a ban or restriction on menthol cigarettes would almost certainly lead some menthol cigarette smokers to attempt to quit, which would increase demand for smoking cessation products. Likewise, the court found that the challenged TPSAC members had an incentive not to make any recommendations in the Menthol Report that would harm their testimony in pending cases.
Apart from barring any use of the Menthol Report, the court also ordered the FDA to reconstitute TPSAC’s membership, so that it would comply with applicable conflict-of-interest laws.
For questions and/or comments, please contact Bryan Haynes, Troutman Sanders tobacco practice partner, at 804.697.1420 or by email.