On Monday, the Supreme Court heard oral arguments in a pivotal case that examines the Food and Drug Administration's (FDA) authority to regulate flavored e-cigarettes. At the heart of the debate are the agency's denials of applications to market fruit-, candy- and dessert-flavored e-liquids, products criticized for their direct appeal to minors. The outcome could redefine the balance of regulatory authority, public health priorities and industry practices in the vaping sector.
Background on FDA Regulation of E-Cigarettes
Under the Family Smoking Prevention and Tobacco Control Act of 2009, any company seeking to market a new tobacco product must demonstrate that doing so would be "appropriate for the protection of the public health."[1] This involves weighing the potential for a product to help current smokers quit against the risk of encouraging new tobacco use, particularly among young people. Since the FDA assumed regulatory authority over e-cigarettes in 2016, the agency has rejected over 1 million applications for flavored products, citing strong evidence that flavors disproportionately attract minors. The FDA contends that flavors pose a "known and substantial risk" to public health by increasing the likelihood young people will use e-cigarette products and subsequently smoke cigarettes.
The Supreme Court Case: Regulatory 'Switcheroo'?
This case arose after two companies, Triton Distribution and Vapetasia, sought to market e-cigarette liquids with the names "Jimmy the Juice Man Peachy Strawberry," "Suicide Bunny Mother's Milk and Cookies," "Iced Pineapple Express" and "Killer Kustard Blueberry" in 2020. The FDA rejected the applications, citing a lack of sufficient evidence demonstrating the products' potential benefits (helping users quit smoking) outweighing the risks (attracting new nicotine users). The companies challenged the FDA's rejection of their applications in the Fifth U.S. Circuit Court of Appeals alleging the FDA shifted its approval standards midstream, making it impossible for their applications to succeed. The Fifth Circuit sided with the companies, calling the FDA's actions a "regulatory switcheroo,"[2] and remanded the case for further consideration. The FDA subsequently appealed to the Supreme Court.
During oral arguments, the justices examined whether the FDA had fairly communicated its standards. Representing the companies, attorney Eric Heyer argued that the FDA's change in evidentiary requirements for approval amounted to a "massive sea change."[3] He argued that the FDA demanded the companies provide longitudinal studies, contradicting earlier guidance that indicated such specific studies were not necessary for premarket tobacco applications. He claimed this violated procedural fairness under the Administrative Procedure Act and the Federal Food, Drug, and Cosmetic Act by ignoring the notice-and-comment process.
A Divided Bench
The justices offered a range of perspectives during the oral arguments, revealing differing priorities in assessing the FDA's actions and highlighting the complexity of balancing public health priorities with regulatory accountability.
The Court's more liberal justices supported the FDA's position, emphasizing that the risks posed to youth by flavored products were well documented and should have been clear to the applicants from the start. But some of the Court's conservative justices, including Justice Clarence Thomas, questioned whether the FDA had adequately communicated its standards or had shifted its requirements midstream, creating an unfair disadvantage to the companies.
Justice Brett Kavanaugh, in a surprising turn for the FDA, appeared to acknowledge the agency's reasoning, emphasizing that if the FDA determines the risks outweigh the benefits, that effectively concludes the statutory inquiry. At the same time, he sought clarity on whether the FDA had altered its evidentiary requirements during the application process, reflecting a balanced approach that recognized the agency's discretion while probing procedural fairness. Kavanaugh expressed skepticism about the practical impact of a ruling in the companies' favor, pointing out that they could reapply for authorization to sell the e-cigarette liquids. He questioned how reapplying would differ from what the companies were seeking through the current legal challenge.
Broader Implications: Public Health vs. Regulatory Overreach
This case has significant implications for public health and regulatory practice. Public health officials have lauded the FDA's stance on flavored e-cigarettes as a necessary step to curb youth nicotine addiction. Data shows a significant decline in youth vaping since its peak in 2019, though an estimated 1.6 million minors still use e-cigarettes – a statistic cited by anti-vaping advocates as evidence of the need for continued strict regulation.
On the other hand, the vaping industry and some experts argue that flavored products play a vital role in helping adult smokers transition away from combustible cigarettes. They contend that the FDA's denial of such products is based on incomplete or outdated data and that a more collaborative approach could balance youth protection with harm reduction for adults.
What's Next?
The Supreme Court's decision, expected by summer 2025, will not only determine the fate of Triton Distribution's and Vapetasia's products but could also set a precedent for how the FDA regulates emerging tobacco and nicotine products. If the Court upholds the Fifth Circuit's ruling, the FDA may face stricter scrutiny in its approval processes, potentially forcing the agency to revise its regulatory approach.
Of course, that's if the Court decides the case. With a new administration taking office on January 20, long before a decision might be issued, the FDA's view on the merits may change. If the agency's new leaders decide that reconsideration of the denials is warranted, that could spell the end of the current litigation, especially if the FDA and the companies at issue agree that the agency should have another bite at the apple.
For now, the vaping industry, public health advocates and federal regulators await a decision that could reshape the landscape of tobacco regulation and determine how far agencies can go in protecting public health without overstepping procedural boundaries.