The United States Supreme Court has permitted e-cigarette retailers to contest the Food and Drug Administration’s (FDA) rejection of an R.J. Reynolds Vapor product application by pursuing legal action in the U.S. Court of Appeals for the 5th Circuit, located in Louisiana. The decision was reached with a 7-2 majority, recognizing the right of retailers in Texas and Mississippi who market R.J. Reynolds Vapor’s e-cigarette products to judicially review the rejection.
This judicial move comes under the Family Smoking Prevention and Tobacco Control Act, which provides that anyone “adversely affected” by an FDA decision regarding new tobacco products can seek a judicial review either via the United States Court of Appeals for the District of Columbia or the circuit of their business location. Notably, the 5th Circuit is considered an appropriate venue for this judicial review, as entities like Avail Vapor, a Texas retailer, and a trade association in Mississippi are based within this jurisdiction and claim they would suffer significant financial harm from the denial.
The FDA had previously sought to have the case transferred to the D.C. Circuit, but the 5th Circuit declined, maintaining that both the trade association and Avail Vapor are indeed “adversely affected” and therefore justified in their legal pursuit.
The opinion delivered by Justice Amy Coney Barrett notes that plaintiffs can invoke a statute only if they are within the “zone of interests” that the statute aims to protect. The existing statute broadly interprets those “adversely affected”, welcoming anyone “arguably” within this domain to challenge decisions. Barrett emphasized that this includes retailers due to the potential loss of profit and legal repercussions if they independently sell the disputed tobacco products.
While the majority avoided resolving whether R.J. Reynolds Vapor itself must independently litigate in the 5th Circuit, arguing that this had not been deliberated at lower court levels, Justice Ketanji Brown Jackson, joined by Justice Sonia Sotomayor, dissented. Jackson’s opposition rests on the assertion that the ruling unduly dilutes the zone-of-interest test, allowing nearly any impacted party the right to sue.