Kaival Brands Innovations Group, Inc. announced that on October 22, 2021, FDA issued an administrative stay, pursuant to 21 C.F.R. ? 10.35, of its Marketing Denial Order for its non-tobacco flavored BIDI Sticks, pending the Agency's review of the Company's request that the MDO be rescinded based on product-specific scientific evidence in its Premarket Tobacco Product Applications . FDA confirmed that while it reviews Bidi Vapor's request, its flavored BIDI Sticks can remain on the market without the threat of enforcement. Prior to the court-ordered September 9, 2020, PMTA deadline and despite considerable business and logistical challenges due to the COVID-19 pandemic, Bidi Vapor submitted PMTAs for all 11 flavor varieties of its BIDI Stick, which is intended exclusively for adult cigarette smokers and tobacco users, 21 and over. The detailed applications ran over 285,000 pages and contained significant information supporting the products as appropriate for the protection of the public health . Despite submitting scientifically rigorous PMTAs and keeping FDA informed about its ongoing clinical and behavioral studies, Bidi Vapor received an MDO for its flavored BIDI Sticks, along with nearly all other manufacturers of flavored ENDS, in early September 2021. On September 29, 2021, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the Eleventh Circuit, seeking judicial review of the MDO under the Tobacco Control Act, the Administrative Procedure Act, as well as the U.S.Constitution. Accordingly, Bidi Vapor has requested the appellate court to vacate the MDO, and provide such additional relief as may be appropriate, including such relief as necessary to ensure that Bidi may continue to market the products subject to the MDO to its adult customers. Bidi Vapor remains committed to regulatory compliance and the premarket review process and is forging ahead with its planned studies to support its PMTAs. The Company's behavioral studies show that the majority of BIDI Stick consumers are older smokers who were either able to transition completing away from smoking or were able to significantly reduce the number of daily cigarettes smoked. This corresponds with the Bidi Vapor's completed clinical pharmacokinetic study, which will soon be published, which demonstrates that the BIDI Sticks deliver nicotine to adult consumers comparable to their usual cigarette brand and also elicited similar subjective effects. In short, the behavioral studies and PK study demonstrate that the BIDI Sticks may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking.