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Kaival Brands Innovations Group Inc. (NASDAQ: KAVL) Win Judicial Stay of the FDA’s Marketing Denial Order

  • Kaival Brands is the exclusive global distributor of products manufactured by Bidi Vapor LLC
  • Bidi Vapor announced that it has been granted a judicial stay of the marketing denial order issued by the FCA in September 2021, which will permit the company to market all its products in the United States, pending the outcome of the lawsuit
  • Kaival Brands expect the decision to result in a significant rebound in BIDI(R) Stick sales, with the company’s distribution partners expected to reestablish previous sales volumes

Kaival Brands Innovations Group (NASDAQ: KAVL), the exclusive global distributor of products manufactured by Bidi Vapor LLC (“Bidi Vapor”), including the BIDI(R) Stick disposable electronic nicotine delivery system (“ENDS”), which is intended exclusively for adults 21 and over, announced, that the U.S. Court of Appeals for the Eleventh Circuit has granted a judicial stay of the marketing denial order (“MDO”) previously issued by the U.S. Food and Drug Administration (“FDA”) to Bidi Vapor in September 2021. The stay order, which was issued on February 1, 2022, allows Bidi Vapor and Kaival Brands to market and sell all of its BIDI(R) Stick ENDS, including its tobacco, menthol, and flavored products within the United States pending the outcome of the lawsuit; moreover, Bidi Vapor has also reiterated its intention to continue with its merits lawsuit which is set to compel the FDA to place Bidi Vapor’s Premarket Tobacco Product Application (‘PMTA’) for the favored ENDS back under scientific review. 

Bidi Vapor had previously submitted PMTAs for all 11 of their flavor varieties (9 flavored ENDS offerings in addition to Menthol and Tobacco) of its BIDI(R) Stick prior to the original September 9, 2020 PMTA deadline, with the detailed applications running to over 285,000 pages – including robust and reliable scientific data supporting that…

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