The U.S. Supreme Court on June 20 ruled 7–2 that retailers wanting to sell a new tobacco product may seek judicial review when the Food and Drug Administration denies approval of the product.
The global vaping market was valued at $28 billion in 2023. Vaping advocates say the devices, which simulate cigarette smoking, assist smokers in quitting smoking cigarettes. Critics say the products, especially flavored varieties, run the risk of addicting young people to nicotine.
Justice Amy Coney Barrett wrote the majority opinion in FDA v. R.J. Reynolds Vapor Co.
The Jan. 21 oral argument focused on procedural issues rather than on whether the FDA was correct in its 2023 ruling denying approval of certain flavored vaping products from the company.
At the hearing, the justices seemed skeptical of federal government arguments for restrictions on where the electronic cigarette industry may sue.
The government argued that the manufacturer had been unfairly gaming the judicial system by engaging in forum shopping—a frowned-upon practice in legal circles—to obtain the most favorable result in court.
The respondent, the R.J. Reynolds Vapor Co., manufactures e-cigarette products marketed under the name Vuse. The company is incorporated and headquartered in North Carolina, which falls within the geographical boundaries of the U.S. Court of Appeals for the Fourth Circuit.
In 2016, the FDA introduced a rule to regulate electronic nicotine delivery systems—battery-powered devices that heat a liquid containing nicotine and transform it into an aerosol to be inhaled by the user.
Reynolds sought FDA approval for its products in three applications, which the FDA denied in 2023. The company appealed the denials of its applications to market its products to the U.S. Court of Appeals for the Fifth Circuit instead of the Fourth Circuit. The Fifth Circuit covers Texas, Louisiana, and Mississippi.
The Fifth Circuit issued an order allowing the products to continue to be marketed while the case was pending. That circuit court allows challenges to FDA product denials to be filed within it, even if the manufacturer isn’t headquartered within the geographical boundaries of the circuit.
Barrett wrote that the federal Family Smoking Prevention and Tobacco Control Act requires manufacturers to obtain approval from the FDA prior to marketing any “new tobacco product.” When the FDA denies an application, the statute allows “any person adversely affected” by the order of denial to petition for judicial review.
“We must decide whether retailers who would sell a new tobacco product if not for the FDA’s denial order have the right to seek judicial review. We hold that they do,” Barrett wrote.
Because a manufacturer and a trade association involved in the litigation maintain their principal place of business in Texas and Mississippi, the Fifth Circuit was correct in ruling that “at least one proper petitioner” had the right to be heard in that circuit, Barrett wrote.
Barrett’s opinion was joined by Justices Clarence Thomas, Samuel Alito, Elena Kagan, Neil Gorsuch, and Brett Kavanaugh, along with Chief Justice John Roberts.
The Supreme Court affirmed the ruling of the Fifth Circuit.
Justice Ketanji Brown Jackson wrote a dissenting opinion, which Justice Sonia Sotomayor joined.
“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,” Jackson wrote.
A cause of action is a set of facts that provides a legal basis for suing someone.
Because nothing in the statute suggests Congress intended to authorize retailers to challenge product denials or to file challenges in “a venue that is otherwise unavailable, I respectfully dissent,” Jackson added.
This article by Matthew Vadum appeared June 20, 2025, in The Epoch Times.