Avail petitioned the 4th U.S. Circuit Court of Appeals to overrule the FDA’s marketing denial decision. Avail’s argument was made on the premise that the FDA did not specify that it needed long-term studies in its 2019 guidance issued to e-cigarette manufacturers. Avail was surprised by the FDA’s later request for this information and that the FDA also refused to take its provided sales plans into consideration when making its decision.
In a January 2022 interview with the Richmond Times-Dispatch, James Xu, Avail’s founder, revealed that he was shutting down his business due to the marketing denial order issued by the FDA. He had hoped to be able to restart the company at some point, though this recent court loss makes it unclear when or how that will happen.
To date, the FDA has denied more than 55,000 applications related to e-cigarette products. These marketing denial orders have been challenged but many of them have been upheld by different U.S. Circuit Courts.
