Kaival Brands Innovations Group Inc (KAVL)

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$KAVL Kaival Brands Partner Bidi Vapor to Contest FDA Denial of ‘Classic’ Tobacco-Flavored ENDS

https://www.globenewswire.com/news-release/2024/01/29/2818885/0/en/Kaival-Brands-Partner-Bidi-Vapor-to-Contest-FDA-Denial-of-Classic-Tobacco-Flavored-ENDS.html

MDO applies only to one Bidi device, ten other flavors still in PMTA process

Kaival Brands remains focused on driving revenue and platform diversification

GRANT-VALKARIA, Fla., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company" or "we,” “our” or similar terms), a company focused on incubating and commercializing innovative products into mature and dominant brands, with a current focus on the distribution of electronic nicotine delivery systems (ENDS), which are intended for adults 21 and over, today announced that its licensor and commercial partner, Bidi Vapor LLC (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.

“Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Niraj Patel, the Founder & Chief Executive Officer of Bidi Vapor, who is also the Chief Science Officer & Founder of Kaival Brands. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored BIDI® Stick. The remaining ten BIDI® Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”

Bidi Vapor has a history of successful outcomes when contesting adverse FDA decisions, having received a favorable Eleventh Circuit ruling in August 2022 that set aside the original MDOs received for its ten non-tobacco flavored products. That ruling put the ten PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products. During this evaluation period, the ten non-tobacco flavored products are still under FDA enforcement discretion.

“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 M. 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.”