Supreme Court Weighs Arguments on FDA’s Regulation of Flavored Vapes

The Supreme Court deliberated Monday on whether the Food and Drug Administration (FDA) acted unfairly in banning flavored e-cigarettes, a decision aimed at reducing youth addiction.

At the heart of the case is whether the FDA's actions in denying approval to two companies, Triton and Vapetasia LLC, were “arbitrary and capricious,” as the companies claim.

The FDA barred the marketing of flavors such as sour grape, pink lemonade, and crème brûlée, including products with names like "Jimmy The Juice Man Strawberry Astronaut" and "Suicide Bunny Bunny Season."

The agency cited insufficient evidence from the companies to prove their products offered enough benefit to adult smokers to outweigh the risk of addiction among young people.

Triton and Vapetasia sued, arguing that the FDA unfairly shifted its evaluation standards mid-process. The companies claimed flavored e-cigarettes help adults quit smoking, but they were unable to meet the FDA’s requirements, which they allege changed without warning.

Lower courts overwhelmingly sided with the FDA, but the conservative 5th U.S. Circuit Court of Appeals accused the agency of moving the goalposts.

The appeals court did not mandate approval of the products but ordered the FDA to reassess its review process.

The FDA appealed to the Supreme Court, arguing that allowing the lower court’s decision to stand would “seriously impair” efforts to protect young people from vaping’s harmful effects. The agency maintains that flavored e-cigarettes are a significant driver of youth addiction.

During Monday’s session, several justices questioned the claims of unfairness. Justice Clarence Thomas asked Justice Department attorney Curtis Gannon to address the accusation that the FDA’s criteria were inconsistent.

Gannon insisted that the agency’s guidance was clear, stating that companies were always aware their products would be judged on their appeal to young people and their potential public health risks.

Justice Brett Kavanaugh appeared to agree, suggesting that once the FDA reviews a product and denies approval, “it’s kind of the end of it, isn’t it?” Justice Elena Kagan also defended the agency’s transparency, telling the companies’ attorney, Eric Heyer, that “there’s not a lot of mystery” in the FDA’s process.

The case comes amid a decline in teen vaping rates, which federal officials attribute to stricter regulations. Despite this progress, the Centers for Disease Control and Prevention reports that over 1.6 million children still use e-cigarettes, with nearly 90% favoring illicit flavored brands.

Currently, the FDA has authorized only 27 e-cigarette products for sale, nearly all tobacco-flavored, while denying millions of applications.

Companies must demonstrate their products are “appropriate for the protection of public health,” a high legal bar given the “known and substantial risk to youth,” according to the FDA.

The future of vaping regulation looms over the case. President-elect Trump has pledged to “save vaping,” even though his administration attempted to restrict flavored e-cigarettes in 2020.

The Vapor Technology Association, representing industry stakeholders, stated the incoming administration could swiftly resolve litigation by implementing a new regulatory standard.

The Supreme Court’s decision could reshape how the FDA regulates flavored vaping products and set a precedent for balancing public health concerns with industry interests.