Supreme Court Declines to Hear Avail Vapor Case
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The U.S. Supreme Court declined on Oct. 10 to hear Avail Vapor’s objections to the Food and Drug Administration’s regulatory authorization process.
In 2021, the regulatory agency denied Avail Vapor’s request to approve fruit-flavored and dessert-flavored e-cigarettes. The company protested that the agency had made the application process intentionally difficult.
In a Supreme Court brief filed Aug. 3, Avail claimed the FDA failed to inform companies of a change in policy that would only allow for approval if the applications included data from studies conducted over time comparing the effectiveness of the multi-flavored products to that of tobacco-flavored products as an aid in adult smoking cessation.
Avail Vapor had asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the FDA to Avail products.
In its petition, Avail asked the Supreme Court to consider the lower court’s legal reasoning and decision.
Among other things, Avail argues that the FDA’s decision-making was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.