Kaival Brands partner Bidi Vapor to contest FDA denial of PMTA for ENDS

Kaival Brands Innovations Group announced that its licensor and commercial partner, Bidi Vapor, will appeal the U.S. Food and Drug Administration’s, FDA, decision to deny Bidi Vapor’s premarket tobacco product application, PMTA, for Bidi Vapor’s “Classic” tobacco-flavored BIDI Stick ENDS device. Kaival Brands holds the worldwide license to distribute products made by Bidi Vapor. On Monday, January 22, 2024, the FDA issued a marketing denial order, MDO, for Bidi Vapor’s “Classic” BIDI Stick PMTA. Importantly, this decision did not involve the ten PMTAs for Bidi Vapor’s non-tobacco flavored devices which are still under the FDA’s scientific review. Those ten products remain available for sale through Kaival Brands, subject to FDA’s enforcement discretion. In response to the MDO, on Friday, January 26, 2024, Bidi Vapor filed a petition requesting that the U.S. Court of Appeals for the Eleventh Circuit review the MDO, which Bidi Vapor believes was, among other things, arbitrary and capricious, in violation of the Administrative Procedure Act. Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation. “While we are disappointed with the FDA’s decision, we are in close contact with Bidi Vapor and laser focused on selling the Bidi Vapor products that we are permitted to,” said Barry Hopkins, Executive Chairman of Kaival Brands. “Like Bidi Vapor, we are fully committed to the legal and responsible use of our products. Moreover, we are committed to increasing Kaival Brands’ revenues by strengthening our existing business and also diversifying our product portfolio, as evidenced by the intellectual property we acquired in May 2023 from GoFire, Inc. We look forward to providing progress updates on our initiatives over the course of 2024.”