NDAQ:KAVL - Post Discussion
Post by
AveragePenny on Feb 04, 2022 1:02pm
Bidi Vapor Wins Judicial Stay of FDA's Marketing Denial
GRANT, Fla., Feb. 3, 2022 /PRNewswire/ -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company," or "we"), is the exclusive global distributor of products manufactured by Bidi Vapor LLC ("Bidi Vapor"), including the BIDI® Stick disposable electronic nicotine delivery system ("ENDS"), which is intended exclusively for adults 21 and over. The Company is pleased to announce 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 ruling, issued on February 1, 2022, allows Bidi Vapor and Kaival Brands to market and sell all of its BIDI® Stick ENDS, including its tobacco, menthol and flavored products, while Bidi Vapor continues with its merits lawsuit compelling the FDA to place Bidi Vapor's Premarket Tobacco Product Application ("PMTA") for the flavored ENDS back under scientific review.
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