The Supreme Court on Friday ruled that retailers can challenge denials of premarket tobacco product applications (PMTAs). R.J. Reynolds Vapor Co., and several convenience retailers, sued the FDA after it denied PMTAs for Reynolds' Vuse Alto, Vibe and Solo menthol vape products.
Under the Family Smoking Prevention and Tobacco Control Act, manufacturers need FDA approval before marketing any new tobacco products. North Carolina-based R.J. Reynolds Vapor Co. applied for permission to sell its Vuse e-cigarettes. But the FDA denied the application in October 2023, which meant retailers had to take the affected products off their shelves.
Several retailers and the Mississippi Petroleum Marketers and Convenience Stores Association, a trade association of gas stations and convenience stores, filed a petition for review in the U.S. Court of Appeals for the Fifth Circuit, stating that the FDA’s decision “adversely affected” them by costing them lost sales.
The FDA moved to dismiss their petition, arguing that the only person who could be “adversely affected” under the Family Smoking Prevention and Tobacco Control Act is the manufacturer who filed the denied application.
However, on Friday, the court ruled 7-2 in favor of the retailers, saying that tobacco product retailers affected by an FDA order can seek judicial review.
“In this decision, the Supreme Court recognized that federal agency action can have downstream effects that can be devastating for parties that are not the most direct target of the agency’s action,” Jones Day partner Ryan J. Watson, who argued the case for respondents, told CSP late Monday. “The Court’s decision ensures that the courthouse doors are not closed for those adversely affected parties.”
Supreme Court Justice Amy Coney Barrett wrote in the case on Friday that “if the FDA denies an application, the retailers, like the manufacturer, lose the opportunity to profit from the sale of the new tobacco product—or, if they sell the product anyway, risk imprisonment and other sanctions.”
In her dissent, Justice Ketanji Brown Jackson on Friday, said the statute does not allow retailers to sue. “And, here, all the usual tools of statutory interpretation point in the same direction: Congress established a detailed scheme for manufacturers to obtain authorization to market new tobacco products—a scheme within which retailers have no rights and play no role—and, in the context of that scheme, Congress provided a cause of action for the protection of the manufacturers’ statutorily created interests. Because nothing in this statute suggests that Congress meant to authorize retailers to sue to challenge the FDA’s denial of a manufacturer’s marketing application, much less bring that legal challenge in a venue that is otherwise unavailable, I respectfully dissent.”
Doug Kantor, general counsel of the National Association of Convenience Stores (NACS), sees this as a positive step for retailers, including convenience stores.
“There is no question that retailers have a direct interest in decisions on premarket approval applications,” said Kantor. “We are pleased that the court recognized retailers’ business needs.”
Daniel Kelly, senior litigation counsel, of the nonpartisan, nonprofit civil rights group New Civil Liberties Alliance (NCLA) said the “ruling is a welcome affirmation that administrative agencies may not creatively interpret statutory terms for the purpose of denying access to the courts by those who have been harmed by agency action.” The Supreme Court’s decision cited NCLA’s amicus brief that advocated this result, NCLA said in a statement.
In April, the Supreme Court ruled on another case regarding the PMTA process in the FDA v. Wages & White Lion Investments.
R.J. Reynolds Vapor Co. declined to comment for this story. The Mississippi Petroleum Marketers and Convenience Stores Association did not respond to CSP's request for comment.
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