Supreme Court declines to hear case challenging FDA authority to reject flavored e-cigarettes

The Supreme Court declined to hear arguments in a case challenging the Food and Drug Administration's authority to reject approvals of flavored electronic cigarettes.E-cigarettes have hooked a new generation on nicotine while ballooning into an $8.2 billion market.to deny applications for flavored e-cigarette products because of its mandate to protect public health by discouraging younger people from smoking.

The FDA said Avail did not present long-term studies demonstrating that its sweet-flavored vapes were more effective at helping adult smokers quit than tobacco-flavored e-cigarettes. Avail in its appeal to the 4th Circuit had argued that the FDA had not said it would need to see long-term studies comparing the company's fruit and dessert-flavored e-cigarettes with tobacco-flavored vapes.

Avail also argued that the FDA was obligated to consider the marketing plan included in its applications.But 4th Circuit Judge J. Harvie Wilkinson wrote in December that Avail "encourages us to neglect the forest for the trees" by focusing on procedural objections rather than the FDA's mandate Avail exited the retail business after selling all of its 100 brick-and-mortar stores in October 2021, a month after the FDA rejected its applications.Avail is not the only company to challenge application rejections from the FDA.

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