Synopsis

Lorillard Inc. and R.J. Reynolds challenged the composition of the Tobacco Products Scientific Advisory Committee (TPSAC). The court determined that the challenge to TPSAC’s report on menthol was not ripe for judicial review.

Background

Section 917 of the Tobacco Control Act establishes the Tobacco Product Scientific Advisory Committee (TPSAC) and designates members from healthcare, the federal government, and the general public to hold voting seats. It gives tobacco product industry representatives non-voting seats. The Act also explicitly prohibits conflicts of interest among the voting members. The Act required TPSAC to issue a report on menthol, which was released in 2011. Shortly thereafter, the industry brought this challenge to the makeup of the TPSAC.

District Court Proceedings

On February 25, 2011, Lorillard Inc., Lorillard Tobacco Company and R.J. Reynolds filed suit in the U.S. District Court for the District of Columbia to challenge the composition of the FDA’s TPSAC and to enjoin the FDA from relying on that committee’s report on menthol in cigarettes.

The plaintiff tobacco companies claimed that three members of TPSAC, including the Chair, had conflicts of interest that would prevent them from providing impartial analyses and recommendations to the FDA regarding tobacco products. The tobacco companies alleged that the TPSAC members at issue had ongoing conflicts of interest and biases because they had previously made statements in support of tobacco control measures, they continued to serve as expert witnesses in litigation against tobacco manufacturers, and served as consultants for pharmaceutical companies that manufacture nicotine-replacement therapies and other smoking-cessation products. The companies alleged that these conflicts affected TPSAC’s consideration of issues relating to menthol in cigarettes and smokeless tobacco products. The plaintiff tobacco companies also alleged that the composition of TPSAC failed to meet the fair balance of viewpoints required by the Federal Advisory Committee Act (“FACA”). Specifically, the companies alleged that “of the eight [then] voting members of the Committee, three (including the Chair) constitute a clique who have the same or similar views….as to whether enough is currently known to conclude that smokeless tobacco products can play a beneficial role in reducing the harm from tobacco.” Lastly, the companies also alleged that TPSAC had violated FACA by conducting a “closed meeting” the day before TPSAC publicly discussed its menthol report and submitted it to FDA.

The companies claimed that the appointment of these TPSAC members harmed them by (1) posing an increased risk that FDA would regulate menthol tobacco products adversely to their interests; (2) allowing TPSAC members access to the plaintiffs’ confidential information; and (3) resulting in their shaping the menthol report to support the challenged TPSAC members’ consulting and expert witness businesses.

The FDA moved to dismiss the suit on several grounds, including that the companies did not have standing to bring a suit. In other words, the alleged harm the companies suffered as a result of TPSAC’s membership was not traceable to any action by FDA, nor would any alternative makeup of the committee result in a different outcome. Second, FDA also argued that it had adhered to the membership requirements outlined by the Tobacco Control Act, which specifies TPSAC’s composition, and that it had complied with the “fair balance” requirements of FACA. As to the conflict of interest claim, the FDA argued that the agency has discretion to enforce conflict of interest rules, so the issue was not reviewable by the court. Further, FDA argued that the allegation that the members of TPSAC had violated FACA by conducting a “closed” meeting also failed from a procedural standpoint because the argument was never raised before the agency–a necessary step before proceeding with a claim in court.

On July 21, 2014, The District Court found in favor of the plaintiff tobacco companies, stating that the FDA erred in concluding that the three challenged members of the TPSAC did not have financial and “appearance” conflicts of interest. Accordingly, The District Court held that “the appointment of those members [to the panel] was arbitrary and capricious, in violation of the [Administrative Procedure Act], and fatally tainted the composition of the TPSAC and its work product, including the Menthol Report.”

On September 18, 2014, FDA filed a notice of appeal to the D.C. Court of Appeals.

Proceedings in the U.S. Court of Appeals for the District of Columbia

On January 15, 2016, a three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit ruled unanimously that the tobacco industry plaintiffs did not have standing to challenge the makeup of TPSAC. In challenging a governmental action, a plaintiff must establish that he or she has suffered a harm or that harm is imminent. The court found that the plaintiff tobacco companies failed to meet this burden, holding that the alleged injuries were too remote and uncertain to support a claim against the FDA. The plaintiffs could point to no actual adverse decision by FDA, nor was the risk of any adverse decision probable or imminent. The court vacated the district court’s judgment and dissolved the injunction that had been issued against using the menthol report and ordering reconstitution of the TPSAC.

Litigation Status

The industry filed no further appeals, rendering the Court of Appeals’ decision final.