by Michael Barbella
Despite concerns about potential health risks, e-cigarettes, first introduced in the U.S. in 2007, have become popular over the nearly two decades they have been on the market, especially among teens and young adults. Opponents of e-cigarettes point to non-traditional flavors like bubble gum, banana, chocolate, cheesecake, cotton candy, ice cream, donut, gummy bear, among others, that lure teens into vaping.
“E-cigarettes with fruit or candy flavoring tend to be appealing to young people and the vast majority of adolescents who use e-cigarettes use flavored products,” according to a January 2025 New England Journal of Medicine article.
Also known as electronic cigarettes or vapes, e-cigarettes are battery-powered devices that heat a liquid to create an aerosol (or vapor) that users breathe into their lungs. Though these aerosols are tobacco-free, most contain nicotine and other chemicals considered harmful to human health. Studies have shown e-cigarettes are less toxic “per puff” than regular cigarettes, but their long-term health effects remain unknown.
FDA regulates
A 2016 Surgeon General’s report estimated there were more than 7,700 unique e-liquid flavors on the market, many of them fruit, candy or dessert flavors. The National Youth Tobacco Survey released by the U.S. Food and Drug Administration (FDA) in 2016 revealed that 1.7 million high school students were vaping. That number jumped to 5 million in 2019 and included middle school students as well.
In 2016, the FDA began regulating e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009. To gain permission to sell their goods, tobacco manufacturers, and now e-cigarette manufacturers, must show the FDA that their product is “appropriate for the protection of public health.” The FDA bases its decision on several factors, including overall population health risks and benefits, whether tobacco users are likely to quit, and whether non-users might pick up the habit.
According to the FDA’s 2024 National Youth Tobacco Survey, there are 1.63 million middle and high school students in the U.S. currently using e-cigarettes. That number is down from 2023 when the agency estimated that 2.13 million students were vaping. The FDA says this is evidence that the agency’s regulations are working to prevent more e-cigarette use among teens. Despite the decrease, however, the FDA also revealed in its 2024 survey that 40% of the students that currently vape admit to doing so frequently, which the FDA maintains is an indication of addiction
The case
In 2019, the FDA issued guidelines outlining the terms for approving new tobacco products. Those original terms did not require the inclusion of long-term studies. The agency said manufacturers could submit observational studies, literature reviews, or evidence comparing their new e-cigarettes to “a studied tobacco product.”
Two years later, however, the FDA declared that tobacco marketing applications without scientific evidence would likely be denied approval. In August 2021, the FDA rejected approximately 1.2 million applications for flavored e-cigarette products.
Among the companies denied approval were Wages and White Lion Investments LLC, doing business as Triton Distribution and Vapetasia, LLC, which makes flavored e-liquids. The firm’s e-liquid flavor offerings include “Killer Kustard Blueberry,” “Rainbow Road,” “Iced Blackberry Lemonade,” “Pineapple Express,” “Suicide Bunny Mother’s Milk and Cookies,” and “Blueberry Parfait.”
Wages and White Lion Investments submitted non-product specific data with its application, including a comprehensive review of scientific literature. But the data fell short, according to the FDA, as it did not provide product-specific scientific proof it would protect public health. In its rejection to Wages and White Lion Investments, the FDA specifically cited the lack of evidence from a “randomized controlled trial, longitudinal cohort study, or another reliable and robust method” that its products had benefits over a similar tobacco-flavored item.
Wages and White Lion Investments sued the FDA, claiming the agency had previously said that product-specific and comparative scientific evidence was not necessary to gain approval. The U.S. Court of Appeals for the Fifth Circuit agreed and, in January 2024, it ruled that the FDA sent flavored e-cigarette manufacturers on a “wild goose chase.” The Fifth Circuit noted there was “ample language” in multiple documents, PowerPoint decks and public meetings to assure manufacturers that no specific studies were needed for approval.
“Part of the tobacco companies’ argument was that the FDA was being wildly inconsistent, sending them on a wild goose chase and doing a ‘surprise switcheroo’ on the evidence needed for authorization,” says Daniel G. Aaron, M.D., a law professor at the University of Utah’s S.J. Quinney’s College of Law, who previously served as Assistant Chief Council at the FDA. “That involved trying to ‘catch’ FDA on informal things it had said and paint FDA’s communications in a negative light.”
In its decision, the Fifth Circuit said the agency did not give e-cigarette manufacturers fair notice of the rules, did not acknowledge or explain its change in position, and tried to “cover up” its mistakes. The Fifth Circuit also determined the FDA acted “arbitrarily and capriciously” (i.e., randomly, unreasonably) in denying flavored e-cigarette product approvals. The FDA appealed the decision to the U.S. Supreme Court.
U.S. Supreme Court decision
The U.S. Supreme Court disagreed with the Fifth Circuit and issued a unanimous decision in April 2025. The Court overruled the lower court’s ruling, finding that the FDA did not act arbitrarily or capriciously and rightfully denied approval to fruit-flavored e-cigarette products. Dr. Aaron notes that the Court didn’t buy the “switcheroo argument.”
“The Court ruled that the FDA had not changed its position and saw FDA’s stance as consistent,” Dr. Aaron says. “For example, FDA was clear that flavored e-cigarettes were risky for youth and manufacturers were on notice they should offer evidence to support the sale of flavored e-cigarettes.”
In the Court’s majority opinion, Justice Samuel Alito wrote, “One particular feature of e-cigarette products appears to drive this youth demand: the panoply of e-liquid flavors…The kaleidoscope of flavor options adds to the allure of e-cigarettes and has thus contributed to the booming demand for such products among young Americans.”
To determine whether FDA changed the rules—or as the Fifth Circuit said, sent e-cigarette manufacturers on a “wild goose chase”—the Court applied its “change-in-position” doctrine to Wages and White Lion Investments’ claims. The doctrine says agencies like the FDA can change existing policies if they provide a “reasoned explanation” for the change, display an awareness about the change, and consider serious “reliance interests.”
Justice Alito wrote, “Affected parties may have come away with the impression that the agency would apply a less demanding standard of proof than is evident in the denial orders the FDA ultimately issued, but in the end, we cannot say that the FDA improperly changed its position with respect to scientific evidence, comparative efficacy, or device type.”
Although the Court admitted the FDA was unable or unwilling to clearly specify the necessary requirements for tobacco product approvals, it also determined the law and guidance documents gave the agency broad discretion to decide the type of scientific evidence companies could submit. The Court also noted the FDA was careful to use words like “may,” “would,” and “likely” in its product approval explanations, which gave the agency more freedom in deciding companies’ marketing applications.
Eric N. Lindblom, a legal and policy analyst and senior scholar at the O’Neill Institute for National and Global Health Law at the Georgetown University Law Center, where he previously served as Director for Tobacco Control and Food & Drug Law, says the FDA was very careful with its wording.
“They never said it would be impossible to get marketing authorization without trials, they said it was likely you would not get one,” Lindblom says.
The Court sent the case back to the Fifth Circuit to decide the one question of whether the FDA made a harmless mistake when it dropped its earlier rule requiring manufacturers to submit marketing plans for their products.
“With respect to the FDA’s guidance on marketing plans, we clarify the appropriate legal standard governing claims of harmless error, and we remand to the Fifth Circuit to apply that standard in the first instance,” Justice Alito wrote.
Lindblom explains that the FDA said it was not going to look at companies’ marketing plans because in its view there wasn’t any way that the product was going to protect the public health.
“The companies said that’s wrong, the law says you have to look at it. And the FDA said you’re right, we blew it. That was an error, but a harmless error, because there’s no way the product would have become a product to protect public health,” Lindblom says. “The Court said you [FDA] did blow it, you have to look at the marketing plans. The Court is not sure it’s a harmless error, so it sent the case back to Fifth Circuit to decide.”
At press time, the Fifth Circuit has not issued a new ruling.
Discussion Questions
- Do you agree or disagree with the FDA’s decision to ban more than one million flavored e-cigarette products? Explain your answer.
- Why do you think fewer teens are vaping today, dropping from 2.13 million (2023) to 1.63 million (2024)?
- Do you think there is enough known about the long-term effects of vaping? Explain your answer.
Glossary Words
appealed—when a decision from a lower court is reviewed by a higher court.
majority opinion—a statement written by a judge or justice that reflects the opinion
overrule—in this case, to void a prior legal precedent.
panoply—an impressive collection of things.
remand—to send a case back to a lower court.
This article originally appeared in the winter 2026 issue of The Legal Eagle, NJSBF’s legal newspaper for kids.