R.J. Reynolds Tobacco v. U.S. Food & Drug Administration

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810 F.3d 827 (D.C. Cir. 2016)

R.J. Reynold’s challenge to the composition of the Tobacco Products Scientific Advisory Committee and its report on menthol is not ripe for judicial review.

Background

On February 21, 2011, Lorillard 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 Tobacco Product Scientific Advisory Committee (TPSAC) 1  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 had conflicts of interest that would prevent them from providing impartial analyses and recommendations to the FDA regarding tobacco products.2  The TPSAC members at issue were allegedly conflicted because they previously made statements in support of tobacco control measures, served as expert witnesses in litigation against tobacco manufacturers, and served as consultants for pharmaceutical companies that manufacture smoking-cessation products.3  The plaintiff tobacco companies also alleged that the composition of TPSAC did not reflect a fair balance of viewpoints, as required by the Federal Advisory Committee Act, claiming that the committee was controlled by a clique of people with similar viewpoints on smokeless tobacco, menthol, and other major tobacco-related issues.4     

The FDA moved to dismiss the suit on several grounds, including that the tobacco companies did not have standing, or the ability to bring a suit, because the alleged harm stemming from TPSAC’s membership was only speculative. The FDA also argued that it had adhered to the membership requirements outlined by the Tobacco Control Act and that it was not the place of the court to arbitrarily substitute its judgment for the FDA’s and make subjective determinations as to which views on tobacco control merit representation. 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.

The District Court’s Decision

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.5 Accordingly, The District Court held that their appointment to the panel was arbitrary and capricious in violation of the Administrative Procedure Act and fatally tainted the composition of the board, including the menthol report.

The Court of Appeals' Decision

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 court did note that each of the industry’s alleged harms could be litigated in the future if that harm were to actually occur. However, because none of the injuries are imminent, the case is not ripe for judicial review.  

Litigation Status

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

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1 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, § 101, 123 Stat. 1776, 1824–25 (amending 21 U.S.C. §387(q) (2006)).       
2 Second Amended Complaint for Declaratory and Injunctive Relief  2, 129–40,  Lorillard, Inc. v. U.S. Food & Drug Admin.,  No. 11-440 (RJL), 2012 WL 3542228 (D.D.C. Aug. 1, 2012), 2011 WL 2790624.
3 Id.  2, 51-75, 109–11.
4 Id.  94-108.
5 Lorillard Inc. v. United States Food and Drug Admin., 56 F.Supp.3d 37 (D.D.C. 2014).