The U.S. Supreme Court will hear arguments on Monday in a case challenging the Food and Drug Administration’s (FDA) decision to block two e-cigarette companies from selling flavored vape products. The FDA cited health risks to youths as the basis for its refusal, marking another high-stakes case involving the power of regulatory agencies.
The FDA is appealing a lower court’s decision that found the agency violated the Administrative Procedure Act by not following proper legal procedures when denying marketing applications from Triton Distribution and Vapetasia.
This case offers the Supreme Court an opportunity to further limit federal regulatory agencies, continuing a trend of rulings that restrict the authority of agencies responsible for interpreting laws, crafting regulations, and implementing executive action.
“This case places the Supreme Court in the role of overseeing the FDA’s scientific decisions,” said Daniel Aaron, a law professor at the University of Utah. “If the Court overrules the FDA, it could allow tens of thousands of potentially harmful e-cigarettes onto the market, while also reinforcing a pattern of judicial interference with agencies’ scientific expertise.”
A 2016 FDA rule classified e-cigarettes as tobacco products, making them subject to the Tobacco Control Act, a 2009 federal law. Under this law, manufacturers must obtain FDA authorization to sell nicotine vaping devices and e-liquids.
Triton and Vapetasia applied in 2020 for approval to market flavored e-liquids such as sour grape, pink lemonade, and crème brûlée. Critics argue these products, with names like “Jimmy The Juice Man Peachy Strawberry” and “Suicide Bunny Mother’s Milk and Cookies,” deliberately appeal to children.
The FDA has approved only 34 flavored e-cigarette products, all limited to tobacco or menthol flavors. Meanwhile, the agency has rejected more than one million applications for products featuring flavors like candy, fruit, and desserts.
Despite these restrictions, flavored e-cigarettes remain widely available, even though they are technically illegal. The FDA relies on the U.S. Justice Department for enforcement, but the department has often declined to crack down on unauthorized flavored vape products, despite FDA requests.
“These companies are flouting the law and using litigation to avoid FDA enforcement,” Aaron said.
To gain FDA approval, e-cigarette companies must demonstrate that their products are “appropriate for the protection of public health.” This requires showing that any potential benefits, such as helping cigarette smokers transition to vaping, outweigh the risks, particularly to minors.
The FDA argues that flavored e-cigarettes pose a “known and substantial risk” to youths, making approval particularly challenging. “The FDA has consistently rejected flavored vaping products because they fail to meet public health standards, given their documented potential to create new underage tobacco users,” said Mark Gottlieb, executive director of Northeastern University’s Public Health Advocacy Institute.
FDA studies reveal that nearly one in five high school students and almost one in 20 middle school students used e-cigarettes in 2020, with flavor cited as a primary reason for vaping. “The popularity of flavored e-cigarettes among youth raises serious concerns about fostering a new generation of nicotine-addicted adults,” Aaron added.
Triton and Vapetasia, however, argue that the FDA subjected them to shifting and unclear requirements, portraying the agency as overly aggressive. In 2021, they asked the 5th U.S. Circuit Court of Appeals to review the FDA’s decision. The 5th Circuit ruled in their favor in January 2023, finding the FDA’s actions “arbitrary and capricious.”
This ruling created a conflict with seven other federal appellate courts, which have sided with the FDA in similar cases, prompting the agency to seek Supreme Court review.
“The 5th Circuit strongly implied that the FDA reached the wrong conclusion when rejecting these applications,” said Micah Berman, a professor of law and health policy at Ohio State University. “It will be fascinating to see whether the Supreme Court justices second-guess the FDA’s weighing of evidence.”
The case underscores the broader tension between regulatory agencies’ scientific assessments and judicial oversight, with significant implications for public health and administrative law.
