Supreme Court Backs FDA’s Denials Of Flavored Vaping Products For Now

In a rare victory for regulatory oversight, the U.S. Supreme Court has upheld the Food and Drug Administration’s (FDA) decision to ban a range of flavored vaping products from the market. The ruling supports the FDA’s efforts to curb youth vaping, though the long-term outcome remains uncertain.

The decision also sends the matter back to the 5th U.S. Circuit Court of Appeals for further review, a move that could extend the legal battle. Despite this judicial backing, the vaping industry isn’t giving up, and a shift in future administration policies—especially given former President Donald Trump’s earlier promise to “save vaping”—could potentially reopen the door for these products.

Justice Samuel Alito authored the majority opinion, with the full court in agreement. The court found that the FDA had not violated any commitments when it denied marketing applications for flavored e-cigarettes, such as “Pink Lemonade,” “Rainbow Road,” and “Jimmy the Juice Man Peachy Strawberry.” These denials, issued early in President Biden’s term, stirred strong backlash from vaping companies.

Alito acknowledged the industry’s frustration, noting their claims of “lack of clear prior notice regarding the type of scientific evidence that was essential for approval.” However, he concluded, “we cannot agree with their argument that the FDA went back on any commitments made.”

Public health advocates applauded the decision. Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids, called the ruling “a major victory for the health of America’s kids,” affirming that the FDA’s rejections were both “legally and scientifically sound.” [source: @TobaccoFreeKids on X]

The vaping industry, however, argues that their products help adult smokers quit and that flavored options play a crucial role in that process. Representing the industry, attorney Eric Heyer said they were “obviously disappointed” but continue to “believe in the great harm reduction potential of their products.” He also confirmed plans to continue fighting in the 5th Circuit.

Vaping among youth has been a growing concern for public health experts. In 2020, FDA data showed that 19.6% of high schoolers and 4.7% of middle schoolers reported using e-cigarettes—figures significantly higher than traditional cigarette use.

In response to such trends, Congress passed a law in 2009 expanding the FDA’s authority to regulate tobacco. By 2016, the FDA had classified e-cigarettes as tobacco products and began reviewing applications for new vaping products.

The vaping companies claim the FDA changed its standards mid-review, suddenly requiring randomized controlled trials to prove that flavored e-cigarettes helped smokers quit more effectively than traditional ones. The 5th Circuit had sided with the industry earlier this year, accusing the FDA of a “regulatory switcheroo.” But seven other appellate courts have dismissed similar complaints.

Justice Sonia Sotomayor added a separate concurring opinion, stating that while the FDA hadn’t definitively settled on an evaluation method, applicants should have known that they needed “rigorous scientific evidence” to demonstrate that the “benefits of their products would outweigh” the “serious risks” to youth.

The case also involves a dispute over marketing plans. Originally, the FDA asked companies to submit strategies for preventing youth access. Later, the agency declined to evaluate those plans, arguing such campaigns had previously failed to be effective. This prompted a technical legal debate about whether the denials should have been sent back to the FDA for reconsideration.

Justice Alito noted that the appeals court may have interpreted previous Supreme Court decisions “too literally,” but also conceded that the FDA’s handling of the marketing plan issue was not entirely correct. As a result, the justices asked the lower court to “decide the question afresh,” leaving the door open for future Supreme Court involvement.

Still, the vaping companies have another option: reapplying for approval. During December arguments, Justice Brett Kavanaugh pointed out that “the companies can always reapply, correct?” to which Department of Justice attorney Curtis Gannon confirmed, “They can reapply without a fee.”

However, Heyer pushed back, saying that the FDA often takes years to process applications. “They can’t afford to wait that out,” he said. “This was their one shot.”