Vape On Trial – The Supreme Court Decision

The Fate of Flavor Hangs in the Balance

On Monday, the Supreme Court heard arguments regarding the FDA’s decision to deny applications for fruit- and dessert-flavored e-cigarette liquids, which the agency argues are particularly enticing to young people.

The justices considered an FDA appeal of a lower-court ruling that criticized the agency for allegedly changing its standards when reviewing applications from two vaping companies.

Over the years, the FDA has rejected more than 1 million applications for flavored e-cigarettes and related liquids, including products mimicking fruit, candy, and desserts. These actions have fueled a high-stakes legal battle between the FDA, tasked with regulating electronic nicotine products, and the multibillion-dollar vaping industry.

Vape in the Crosshairs of a Closely Watched Case

The case hinges on the 2009 Family Smoking Prevention and Tobacco Control Act, which mandates FDA approval for any tobacco product introduced after 2007. The two companies challenging the FDA assert their 2021 applications were improperly denied. The FDA contended that the companies failed to provide adequate evidence that their products’ benefits outweighed their risks. However, the companies argue the agency raised its evidentiary standards without warning, making approval unattainable.

The U.S. Court of Appeals for the 5th Circuit sided with the companies, overturning the FDA’s denial and sending the case back for further review. The FDA has since appealed the decision to the Supreme Court.

During oral arguments, some conservative justices seemed inclined toward the companies’ position. Justice Clarence Thomas questioned whether the FDA’s approach made the approval process a “moving target.”

This legal battle unfolds as federal data shows youth e-cigarette use has dropped nearly 70% since its peak in 2019, reaching its lowest level in a decade. Meanwhile, critics argue the FDA is slow to accept evidence that e-cigarettes are less harmful than traditional cigarettes and could aid in smoking cessation.

The Supreme Court is expected to issue a decision by summer, potentially reshaping the future of FDA regulation and the vaping industry.