The U.S. Supreme Court will review a major dispute over the Food and Drug Administration’s (FDA) authority to deny approval of flavored e-cigarette products, marking a pivotal moment in the ongoing battle between public health concerns and regulatory oversight. On Monday, the Court will consider whether the FDA followed proper legal procedures in denying applications from Triton Distribution and Vapetasia to market their flavored nicotine products, which the agency argues pose significant risks to youth health.
The case follows the FDA’s appeal of a lower court ruling, which found that the agency had not adhered to the requirements of the Administrative Procedure Act (APA) when rejecting the companies’ applications. This legal challenge presents an opportunity for the Supreme Court to weigh in on the broader issue of federal agency power, especially following a series of recent decisions that have limited regulatory agencies’ authority to interpret and enforce laws.
“This case places the Supreme Court in the unique position of determining whether the FDA’s scientific findings about public health risks are subject to judicial override,” said Daniel Aaron, a law professor at the University of Utah. “If the Court sides with the plaintiffs, it could open the floodgates for tens of thousands of e-cigarette products that the FDA has determined to be harmful, while continuing a trend of judicial interference in agency decision-making.”
The FDA’s Stance on E-Cigarettes and Youth Health Risks
In 2016, the FDA issued a rule designating e-cigarettes as tobacco products, subject to regulation under the Tobacco Control Act of 2009. This law mandates that manufacturers must seek FDA approval to sell nicotine-containing devices and e-liquids. In 2020, Triton and Vapetasia submitted applications for e-cigarette products in flavors such as sour grape, pink lemonade, and crème brulee—flavors critics argue are specifically designed to appeal to minors.
The FDA has approved only 34 flavored e-cigarette varieties, all tobacco or menthol flavored, and rejected applications for over a million other products, citing concerns that such flavored products encourage youth vaping. Despite this, unauthorized flavored e-cigarettes remain widely available, as the FDA lacks the authority to enforce its regulations without the cooperation of the U.S. Justice Department, which has been hesitant to act.
“This litigation is a blatant attempt to circumvent the FDA’s authority, with companies flouting the law in hopes of a favorable ruling,” said Aaron.
Health Risks and Youth Usage
The FDA argues that flavored e-cigarettes pose a “known and substantial risk” to public health, particularly among minors. According to the agency, e-cigarettes have become the most widely used tobacco product among youth, with nearly one in five high school students and one in 20 middle school students using them. The FDA maintains that the widespread use of flavored e-cigarettes contributes to this alarming trend, as many youth cite flavoring as a key reason for their use.
“Flavored e-cigarettes have become a gateway to nicotine addiction for a new generation,” said Mark Gottlieb, executive director of Northeastern University’s Public Health Advocacy Institute. “By approving flavored products, the FDA would be facilitating the creation of lifelong nicotine users.”
Micah Berman, a law and health policy professor at Ohio State University, noted that the case highlights a stark divide in viewpoints. The FDA insists it is simply enforcing a law designed to protect minors, while e-cigarette manufacturers argue that the agency’s regulatory actions have been arbitrary and unclear.
The Legal Battle Continues
In 2021, Triton and Vapetasia challenged the FDA’s denial of their applications before the 5th U.S. Circuit Court of Appeals, which ruled in their favor in January 2023. The 5th Circuit found that the FDA had acted in an “arbitrary and capricious” manner, violating the APA, and ordered the agency to reconsider the companies’ applications.
This decision created a legal rift, as seven other federal appellate courts have sided with the FDA in similar cases. The ruling has prompted the agency to appeal to the U.S. Supreme Court, seeking to clarify whether the FDA’s decisions regarding public health and scientific findings can be subject to judicial review.
“The 5th Circuit’s ruling suggests that the FDA misinterpreted the law,” said Berman. “The Supreme Court will now have the opportunity to decide whether the FDA’s actions were justified or whether a broader reevaluation of how these products are regulated is necessary.”
The outcome of this case could have far-reaching implications not only for e-cigarette regulations but also for the broader authority of federal agencies to regulate products that may pose health risks to the public.
READ MORE: