Supreme Court to Hear Arguments Over FDA’s Rejection of Flavored Vape Products

E-cigarettes are displayed at Gone With the Smoke Vapor Lounge in San Francisco on May 5, 2016. Justin Sullivan/Getty Images

The U.S. Supreme Court is expected to hear oral argument on Dec. 2 over the Food and Drug Administration’s (FDA) decision to reject two companies’ request for authorization to market various vape flavors.

FDA v. Wages and White Lion Investments is one of multiple cases related to e-cigarettes to make it to the Supreme Court this term and raises questions about the impact of products like flavored vaping liquid on public health, particularly for minors.

The court is also expected to hear a related case in January over the judicial circuits wherein vape companies can sue. At issue in the Dec. 2 case is whether the FDA violated the Administrative Procedure Act (APA), which governs how agencies develop and implement regulations.

U.S. Solicitor General Elizabeth Prelogar is asking the justices to reverse a decision in which the U.S. Court of Appeals for the Fifth Circuit said the FDA violated that law. Two companies—Vapetasia and White Lion Investments, which is doing business as Triton Distribution—told the Supreme Court it should uphold the Fifth Circuit’s decision.

The case could help determine how agencies regulate a growing market, which was valued at $28 billion in 2023. Proponents say the products help smokers transition away from the harmful effects of traditional cigarettes. Critics worry about minors using vaping products, which often contain nicotine.

Earlier this year, the U.S. Court of Appeals for the Fifth Circuit said that the agency had effectively banned flavored e-cigarette products. “As of today, FDA has not approved a single [application] for a single one of the more than 1 million flavored e-cigarette products submitted to the agency,” the court said in January.

An opinion from Judge Andrew Oldham, appointed by President-elect Donald Trump during his first term, said that the FDA had illegally switched its approach to evaluating whether e-cigarette products met public health standards and failed to inform the companies until after they submitted their applications.

“FDA argues that its years’ worth of regulatory guidance was not worth the paper it was printed on,” Oldham wrote. Oldham’s opinion was joined by nine other judges on the court while six dissented. He said the FDA’s decision to reject the companies’ product applications was “arbitrary” and “capricious,” or the sort that courts can overrule under the APA.

Prelogar defended the FDA by arguing that it hadn’t enacted a de facto ban on flavored e-cigarette products. Instead, she said, the agency’s actions were consistent in applying the Tobacco Control Act, which in 2016 the FDA said covered e-cigarettes.

The case has drawn input from businesses in the industry as well as health groups. An amicus brief from the Coalition of Manufacturers of Smoking Alternatives argued that products like e-cigarettes “provide a lower-risk alternative for millions of adult smokers seeking to transition and remain away from using combustible cigarettes.”

Major medical organizations, meanwhile, submitted an amicus brief arguing that youth usage of e-cigarettes was a “public health crisis” with potentially permanent effects given adolescents’ developing brains.

“As FDA has denied applications for marketing authorization of flavored e-cigarettes in recent years, youth e-cigarette use has declined, but remains unacceptably high today, with 2.1 million high school and middle school students currently using these products,” the brief from the American Medical Association, American Academy of Pediatrics, and others read.

The case has also raised questions about the court’s recent decisions in Loper Bright Enterprises v. Raimondo, which overruled the decades-old Chevron deference doctrine, and West Virginia v. Environmental Protection Agency, which utilized the Major Questions Doctrine.

In October, 13 members of Congress submitted an amicus brief that the FDA’s decisions represented the type of regulatory changes that the Supreme Court saw as problematic when overruling the Chevron doctrine. The doctrine, established in 1984 and overturned in June this year, required courts to defer to federal agencies’ interpretation of ambiguous laws, regardless of whether it aligned with judges’ interpretation.

They also joined industry stakeholders in arguing that the FDA’s decision to regulate e-cigarette and vaping products violated the Major Questions Doctrine, which generally requires some kind of congressional authorization before agencies can make determinations about issues of great economic or political importance.

The Supreme Court used the doctrine to strike down President Joe Biden’s sweeping student debt forgiveness plan in 2023. The members of Congress and industry stakeholders have argued that it should also apply to the way the FDA has regulated e-cigarette products.

In May, stakeholders suggested the Tobacco Control Act may be unconstitutional since it contains a provision that allows the federal government to deem certain “tobacco products” as subject to regulation.