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R.J. Reynolds v. United States Food and Drug Administration

Tobacco companies challenged the composition of the Tobacco Products Scientific Advisory Committee (TPSAC), which was established by the U.S. Food and Drug Administration (FDA) to advise the agency on scientific issues related to tobacco products, including the use of menthol in cigarettes. The tobacco companies alleged that three of the scientific members of the Committee had both an actual and a perceived conflict of interest because each consulted with companies that developed nicotine replacement therapies and testified as expert witnesses in lawsuits against tobacco manufacturers. The court ruled in favor of the tobacco companies, finding that the challenged committee members had both financial conflicts of interest and an appearance of conflicts of interest, which fatally tainted the composition of the Committee and its work product, including the 2011 Committee report on menthol in cigarettes. The court issued an order requiring the FDA to reconstitute the Committee’ membership to comply with ethics laws and barred the agency from using the Committee’s menthol report, which had recommended removing menthol cigarettes from the marketplace.  The FDA appealed, and a three-judge panel of the appeals court unanimously reversed the lower court ruling, finding that plaintiffs had not shown imminent injury from the appointment or the actions of challenged Committee members.