Stay Granted By 11th Circuit in Challenge to Bidi Vapor’s Marketing Denial Order

On February 2, 2022, the 11th Circuit Court of Appeals granted Bidi Vapor LLC’s motion to stay its marketing denial order (MDO) issued by the Food and Drug Administration (FDA) for its non-tobacco flavored electronic nicotine delivery systems (ENDS). Bidi Vapor, represented by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury, petitioned the Court of Appeals to review FDA’s denial of the company’s Premarket Tobacco Product Applications (PMTA) for its BIDI® Stick ENDS, arguing that it was arbitrary and capricious under the Administrative Procedure Act (APA), as well as ultra vires, for FDA not to conduct any scientific review of the company’s comprehensive applications, as required by the Tobacco Control Act, to determine whether the BIDI® Sticks are “appropriate for the protection of the public health” (APPH). Bidi Vapor further argued that FDA violated due process and the APA by failing to provide fair notice of the Agency’s new requirement for ENDS companies to conduct long-term comparative smoking cessation studies for their flavored products. 

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