Synopsis

“Like a smoker daily promising himself he will quit tomorrow, the FDA keeps assuring the public it will promulgate a final rule on menthol cigarettes at some later date,” reasoned the United States District Court for the District of Columbia in this case. The case casts a spotlight on a troubling pattern of inaction by the U.S. Food and Drug Administration when it comes to addressing the significant public health concerns around menthol cigarettes, but it also highlights what innovative litigation can do to combat this inaction.

Why It Matters for Public Health

Reeves v. 7-Eleven underscores the demand for accountability and swifter regulatory action in the face of the continued sale of menthol cigarettes. It serves as a potent reminder of the inefficiencies that the FDA’s prolonged administrative delays on the menthol rule can generate, impacting consumer rights and public health.

Background

In November of 2022, S.J. Reeves and H. O’Malley, two residents of Washington, D.C., launched a class action suit against 7-Eleven. The crux of their complaint lies in the sale of menthol cigarettes. They specifically allege violations of Washington, D.C.’s Consumer Protection Procedures Act, negligent misrepresentation, breach of the implied warranty of merchantability, and breach of the implied warranty of fitness for a particular purpose. The plaintiffs seek both damages and injunctive relief, which would require 7-Eleven to disclose the added dangers presented by menthol cigarettes (i.e., the particular health risks posed by cigarettes when menthol is added to them).

Proceedings

In February of 2023, the parties agreed to pause the proceedings and wait for the FDA to move forward with its proposed rule to ban menthol cigarettes. Initially, this stay seemed a prudent measure, given the expertise required to evaluate thoroughly the risks associated with menthol cigarettes. However, the FDA’s repeated delays muddied the waters and compelled the plaintiffs to seek a lifting of the stay.  As the court noted, the FDA’s anticipated release of the menthol rule by August of 2023 is now uncertain, with no clear timeline or end in sight. This prolonged delay  undermined the initial rationale for the stay, which led the court to reconsider its position. In evaluating the motion to lift the stay, the court considered:

1. The FDA’s extended delays: The repeated postponements by the FDA outweigh the initial advantages of the stay.
2. Judicial competence: Despite the FDA’s expertise in regulatory matters, courts are well-equipped to address issues of deceptive practices effectively.
3. Risk of inconsistent rulings: There is minimal risk of contradictory decisions between the court and the FDA, as questions about 7-Eleven’s disclosure responsibilities can be independently adjudicated.
4. Administrative disadvantage: Continued delays pose unnecessary disadvantages to plaintiffs seeking urgent relief and resolution.

Litigation Status (OPEN)

Determined to address the public health concerns of menthol cigarettes without further delay, the court vacated the stay on July 22, 2024, reinstating the case to an active docket.