Important Appeals Court Decision Means FDA Now Free To Use Scientific Committee Recommendations on Menthol: R.J. Reynolds V. FDA

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When the Family Smoking Prevention and Tobacco Control Act became law in 2009, giving the U.S. Food and Drug Administration the authority to regulate tobacco products, it created a group of scientists called the Tobacco Products Scientific Advisory Committee (TPSAC) to guide agency decision-making. The Act directed TPSAC to take up the issue of menthol tobacco products as its first order of business.

The FDA promptly populated the committee with a group of experts whose vast scientific research experience qualified them to evaluate data related to the impact of different tobacco products on public health. Following Congress’s directive, TPSAC began its work with an exhaustive review of the evidence related to menthol in tobacco products. In March 2011, the committee released its 252-page report, Menthol Cigarettes and Public Health: Review of the Scientific Evidence and Recommendations, concluding that “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.”

Unsurprisingly, given that nearly all of Lorillard’s revenue comes from menthol cigarettes, the company took the lead in suing the FDA in hopes of preventing action on menthol. In the lawsuit, Lorillard challenged the integrity of TPSAC, alleging that several experts the agency appointed to the committee were biased and therefore must be removed. In a startling display of the twisted logic Big Tobacco is famous for, Lorillard complained that three members of TPSAC were rendered unfit for the committee due to their extensive experience in the field of tobacco and cessation product science, and the health impact of both kinds of products. In other words, in Lorillard’s world, only scientists who had not worked in the field of tobacco control and cessation should be permitted to evaluate tobacco product science. Lorillard further argued that anything TPSAC produced while the allegedly biased members were participants could not be relied upon for action by the FDA.

The case was filed in federal court and was assigned to District Court Judge Richard Leon, a jurist with a reputation for siding with Big Tobacco. Sure enough, Judge Leon embraced Lorillard’s arguments that the experts on TPSAC were biased as a result of their relevant expertise, banishing the challenged members of TPSAC and ordering the FDA to disregard TPSAC reports and findings issued while those experts were part of the committee. The FDA appealed, and on January 15, 2016, the D.C. Circuit reversed Judge Leon’s decision, holding instead that the plaintiff (now R.J. Reynolds after it bought Lorillard) had not suffered any actual damages, as is required to bring this sort of claim.

Most importantly, after tobacco companies managed to use litigation to delay action for years, the appellate court’s ruling frees the FDA to rely on the TPSAC menthol report to take action to regulate menthol tobacco products. That report is only one part of the enormous evidence base supporting bold action to remove menthol tobacco products from the market. The FDA has the evidence and the authority to act now to protect public health, including the 19 million Americans who smoke menthol cigarettes or the 2.2 million kids who will start smoking this decade if those products remain on the market. There is no excuse for further delays.

February 15, 2016


Joelle Lester is a Staff Attorney at the Tobacco Control Legal Consortium at the Public Health Law Center at Mitchell Hamline School of Law.