On Tuesday, the Supreme Court declined to entertain arguments in a case challenging the Food and Drug Administration’s authority to reject approvals of flavored electronic cigarettes.
This case is one of several legal challenges against the FDA’s regulatory framework for the vaping industry, which has both ensnared a new generation in nicotine addiction and grown into an $8.2 billion market within a decade.
In December, the 4th Circuit U.S. Court of Appeals upheld the FDA’s authority to deny applications for flavored e-cigarette products, citing the agency’s responsibility to safeguard public health by discouraging youth smoking.
Avail Vapor, a vape retailer, had appealed the lower court’s decision, contending that the FDA had changed its application requirements without proper notice.
Avail’s attorney, Eric Heyer, expressed disappointment with the Supreme Court’s decision, stating, “We are disappointed that the Supreme Court declined to review the flawed process by which FDA issued its marketing denial orders to Avail without adequate prior notice.”
The FDA issues marketing denial orders to reject product applications. A spokesperson for the FDA did not immediately comment on the Supreme Court’s decision.
In 2016, the FDA classified e-cigarettes as regulated products akin to traditional tobacco items. E-cigarettes are handheld devices used to inhale a vapor containing nicotine, flavorings, and other chemicals.
The agency mandated that companies submit applications for approval of their vape products by September 2020, even those already on the market.
As of March, nearly seven million applications were submitted, but more than one million were rejected.
The legal dispute centers on the FDA’s 2021 decision to reject all of Avail Vapor’s applications for its fruit- and dessert-flavored e-cigarettes.
The FDA asserted that Avail had failed to present long-term studies proving its sweet-flavored vapes effectively helped adult smokers quit compared to tobacco-flavored e-cigarettes.
Avail’s applications included studies on the safety and usability of its products but lacked comparative efficacy studies against tobacco-flavored vapes. Avail argued that the FDA had not explicitly communicated the need for such studies beforehand.
However, 4th Circuit Judge J. Harvie Wilkinson maintained in December that Avail’s focus on procedural objections missed the FDA’s broader mandate to prevent nicotine addiction in future generations.
He clarified that the FDA rejected Avail’s applications due to insufficient evidence of product benefit, not solely due to procedural issues.
Following the FDA’s rejection of its applications, Avail exited the retail sector by selling all its brick-and-mortar stores in October 2021.
Avail is not alone in contesting FDA decisions. Last year, the FDA ordered Juul products off the market, citing inadequate evidence of public health safety.
Juul, which downsized its workforce significantly to avoid bankruptcy, criticized the FDA’s assessment as incorrect and incomplete.
The FDA is conducting a secondary review of Juul’s data, with current provisions allowing Juul’s products to remain on the market.
Despite efforts to restrict teen-favored e-cigarette flavors, sales of these products rose significantly between January 2020 and December 2022.
Many popular disposable e-cigarette brands currently on the market lack FDA approval and are illegal.
