Bidi Vapor Fights FDA's Marketing Denial of Tobacco-Flavored ENDS Device

The FDA issued the MDO following a review of Bidi Vapor's premarket tobacco product application (PMTA) for the device and determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Following the Jan. 22 decision, Kaival Brands Innovations Group Inc. said that Bidi Vapor, its licensor and commercial partner, will appeal the agency's denial. Kaival Brands holds the worldwide license to distribute products made by Bidi Vapor.

According to Kaival Brands, the FDA's decision did not involve the 10 PMTAs for Bidi Vapor's nontobacco flavored devices which are still under the FDA's scientific review. Those products remain available for sale through Kaival Brands, subject to the agency's enforcement discretion.

On Jan. 26, 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 and CEO of Bidi Vapor, who is also the chief science officer and 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 10 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 10 nontobacco flavored products. That ruling put those 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 10 nontobacco 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."

Based in Grant-Valkaria, Kaival Brands is focused on incubating and commercializing innovative products into mature and dominant brands, with a current focus on the distribution of ENDS for use by customers 21 years and older. Kaival Brands and Philip Morris Products S.A. (via sublicense from Kaival Brands) are the exclusive global distributors of all products manufactured by Bidi Vapor LLC.