U.S. Supreme Court Declines to Hear Challenge to FDA's Authority to Reject Flavored Vapor Products

WASHINGTON, D.C. — The United States Supreme Court will not hear arguments in a case regarding the U.S. Food and Drug Administration's (FDA) authority to reject approvals of flavored e-cigarettes.

This leaves in place a ruling by the U.S. Court of Appeals for the Fourth Circuit that found the FDA has the power to deny applications for flavored e-cigarettes due to its mandate to protect public health by discouraging young people from smoking.

The Fourth Circuit's ruling denied an appeal by vape retailer Avail Vapor, which argued that the FDA unfairly denied its product applications based on requirements that it had changed without notifying companies.

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Eric Heyer, attorney for Avail Vapor, told CNBC that the company is "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 of the specific longitudinal comparative efficacy study requirements the agency ultimately imposed."

The case in question was prompted by the FDA's rejection of all Avail Vapor's applications for fruit- and dessert-flavored e-cigarettes in 2021. According to the agency, Avail did not present long-term studies demonstrating that these sweet-flavored c-cigarettes were more effective at helping adult smokers quit than tobacco-flavored e-cigarettes. The agency stated that such studies are necessary to demonstrate that the benefits of Avail's products to adults outweigh their risks to young people, who are attracted to sweet-flavored e-cigarettes.

Avail's applications included four studies that surveyed patients on the safety and usability of some of its products but did not make any comparisons to tobacco-flavored e-cigarettes. The applications did include Avail's marketing measures, including age verification for online sales.

In its appeal to the Fourth Circuit, Avail stated that the FDA had not informed the company that it would need to see long-term studies comparing its sweet-flavored e-cigarettes to tobacco-flavored e-cigarettes. It also argued that the FDA is obligated to consider the marketing plan included in its applications.

"The FDA says Avail and other retailers should have known what they were going to be looking for. Well, virtually nobody in the industry knew," Heyer said. "The lack of those comparative efficacy studies was one of the main reasons why the FDA denied these applications. The FDA had five years to communicate this to applicants and they never did."

However, Fourth Circuit Judge J. Harvie Wilkinson expressed that Avail "encourages us to neglect the forest for the trees," focusing on procedural objections instead of the FDA's mandate to "ensure that another generation of Americans does not become addicted to nicotine and tobacco products."

He wrote that the FDA did not reject Avail's application due to the lack of specific long-term studies, but instead followed its mandate by requiring strong, product-specific evidence to evaluate the benefit of new e-cigarette products to adults.

Avail exited the retail industry after selling its 100 brick-and-mortar stores in October 2021, one month after the FDA rejected its applications.