In a landmark decision, the U.S. Supreme Court unanimously upholds the Food and Drug Administration’s (FDA) authority to deny applications for flavored e-cigarette products, overturning a lower court ruling that had accused the agency of improperly altering its approval standards. The ruling, issued today, April 2, 2025, in Washington, D.C., solidifies the FDA’s power to regulate new tobacco products based on public health concerns, particularly the risks posed to youth by enticing flavors like peach and strawberry. However, the justices leave one key issue unresolved, remanding it to a lower court for further review: whether the FDA must consider e-cigarette companies’ marketing plans as part of the approval process. This decision marks a significant moment in the ongoing battle between federal regulators and the vaping industry, with implications for public health and the future of flavored nicotine products.
The case centers on the FDA’s rejection of applications from two e-cigarette companies, Triton Distribution and Vapetasia, which sought approval to market flavored e-liquids with names like “Jimmy The Juice Man Peachy Strawberry” and “Suicide Bunny Mother’s Milk and Cookies.” The FDA, tasked with overseeing tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act, denies these applications in 2021, citing insufficient evidence that the products’ benefits to adult smokers outweigh their appeal to minors. The agency’s stance reflects a broader crackdown on flavored vapes, which it links to a surge in youth nicotine use over the past decade. The Supreme Court’s ruling comes after the New Orleans-based 5th U.S. Circuit Court of Appeals reverses the FDA’s decision in January 2024, arguing that the agency engages in a “regulatory switcheroo” by shifting its evaluation criteria mid-process without fair notice to applicants.
Justice Samuel Alito, writing for the unanimous court, asserts that the FDA’s actions remain within the bounds of the Administrative Procedure Act, which governs federal agency conduct. He acknowledges that companies may have perceived the agency’s standards as less stringent than they prove to be, but he rejects the notion that the FDA unlawfully changes its position. “The denial orders were sufficiently consistent with its predecisional guidance,” Alito writes, emphasizing that the agency’s focus on scientific evidence and public health risks is clear throughout the process. However, the court stops short of fully endorsing the FDA’s approach, noting that the agency’s refusal to consider Triton and Vapetasia’s marketing plans—intended to limit youth access—requires further scrutiny. The case now returns to the 5th Circuit to determine whether this omission violates federal law.
The vaping industry, valued at billions of dollars, argues that flavored products serve as critical tools for adult smokers seeking to quit traditional cigarettes, which claim 480,000 lives annually in the U.S. due to cancer, lung disease, and heart disease. Triton and Vapetasia, along with their attorney Eric Heyer, contend that the FDA imposes unexpected requirements, such as randomized clinical trials, that render compliance nearly impossible. “Triton and Vapetasia continue to believe in the great harm-reduction potential of their products,” Heyer states after the ruling, expressing disappointment but vowing to press forward. Critics of the FDA, including some industry advocates, point to the agency’s approval of only 34 e-cigarette products—all tobacco or menthol-flavored—as evidence of an overly restrictive stance that stifles innovation and adult choice.
Public health advocates, however, hail the decision as a victory for America’s youth. The FDA reports that in 2024, 1.63 million middle and high school students use e-cigarettes, with 89% favoring flavored varieties. The Campaign for Tobacco-Free Kids, in a statement released today, calls the ruling “a major win for the health of our kids,” crediting the FDA’s restrictions with reducing youth vaping from a peak of 5 million in 2019 to its lowest level in a decade. The agency’s authority stems from a 2016 rule classifying e-cigarettes as tobacco products, requiring manufacturers to demonstrate that new products are “appropriate for the protection of the public health.” This standard weighs the potential benefits for adult smokers against the risks of attracting new, often underage, users—a balance the FDA says flavored vapes consistently fail to achieve.
The backstory of this dispute traces back to the early 2000s, when e-cigarettes first emerge in the U.S. market as a novel alternative to smoking. Initially unregulated, their popularity explodes after 2010, with flavored options like fruit, candy, and dessert varieties driving a youth vaping epidemic by the late 2010s. The FDA, slow to act at first, faces criticism for allowing the market to balloon before imposing oversight. In response, Congress passes the Tobacco Control Act in 2009, granting the agency broad powers to curb tobacco use among adolescents. By 2016, the FDA extends these powers to e-cigarettes, prompting a flood of applications—nearly 7 million by the 2020 deadline—from companies seeking to legitimize their products. The agency rejects over 1 million of these, including Triton and Vapetasia’s, sparking a wave of legal challenges across the country.
Unlike seven other federal appeals courts that uphold the FDA’s denials, the 5th Circuit’s 10-6 ruling in 2024 stands out for its sharp rebuke of the agency. Judge Andrew Oldham, a Trump appointee, accuses the FDA of misleading companies with vague guidance, only to deny applications based on unannounced standards. The Supreme Court’s decision today vacates that ruling, aligning it with the broader judicial consensus that the FDA’s actions are “reasonable and reasonably explained,” as U.S. Solicitor General Elizabeth Prelogar argues in court filings. Yet the remand on the marketing issue leaves room for the vaping industry to challenge the agency’s process further, potentially reshaping how future applications are evaluated.
Breaking news updates as of 11:47 AM PDT on April 2, 2025, indicate that the vaping industry is already mobilizing for the next phase of the fight. Sources suggest that Triton and Vapetasia plan to refile their applications, incorporating stronger marketing restrictions to address the court’s concerns. Meanwhile, the incoming Trump administration, set to take office in January 2025, adds a layer of uncertainty. President-elect Donald Trump, who promises to “save” vaping in a September 2024 social media post, may push for a more lenient regulatory approach, potentially reversing years of FDA policy. Public health groups express alarm at this prospect, warning that a rollback could undo progress in curbing youth nicotine addiction.
The ruling also arrives amid broader shifts at the FDA. The agency faces internal challenges, including mass layoffs at its Center for Tobacco Products, which oversees e-cigarette reviews. Critics argue that these cuts, reported in early 2025, hinder the FDA’s ability to process applications efficiently, fueling industry frustration. Historically, the agency’s tobacco regulation efforts have faced legal pushback—most recently in November 2024, when the Supreme Court declines to hear a challenge to graphic cigarette warning labels. Today’s decision, however, reinforces the FDA’s role as a gatekeeper, even as it navigates a complex landscape of science, policy, and politics.
As the case returns to the 5th Circuit, observers anticipate a contentious debate over the marketing question. Legal experts suggest that a ruling in favor of the companies could force the FDA to adopt a more holistic review process, potentially opening the door to some flavored products. For now, the Supreme Court’s decision stands as a partial victory for the FDA, affirming its core authority while leaving the vaping industry with a glimmer of hope. The outcome underscores the delicate balance between protecting public health and preserving adult access to alternatives—a tension that shows no signs of abating as the nation watches this saga unfold.
Sources:
- Video: https://youtu.be/QSTzlTUsaSk
- Reuters, “US Supreme Court largely backs FDA’s denial of flavored vape product applications,” April 2, 2025
