Bidi Vapor to appeal FDA’s sales denial order

Bidi, in collaboration with commercial partner Kaival Brands, challenged the FDA’s recent decision to deny the Premarket Tobacco Product Application (PMTA) for Bidi’s “Classic” Tobacco Flavor ENDS.

by Kevin McIntyre | January 29, 2024

Just one week after the Food and Drug Administration (FDA) denied Bidi Vapor’s PMTA for Bidi Vapor’s “Classic” tobacco-flavored ENDS device, the company, along with Kaival Brands Innovations Group, announced that it will appeal the decision.

Kaival Brands holds a license to sell Bidi Vapor products worldwide.

The FDA’s decision did not include Bidi Vapor’s 10 PMTAs of non-tobacco-flavored devices, which are still under FDA scientific review, but only the company’s tobacco-flavored ENDS device. These 10 products will continue to be available for sale through Kaival Brands, subject to FDA enforcement discretion.

In response to the Marketing Denial Order (MDO), on Friday, January 26, Bidi Vapor filed a petition with the U.S. Court of Appeals for the Eleventh Circuit asking for reconsideration of the MDO, which Bidi Vapor claims is “arbitrary, capricious and violating.” I think that’s what I’m doing. ” the company said in a press release.

Biddy Vapor also plans to call for a moratorium on the multinational force pending the outcome of the lawsuit.

“Bidi Vapor disagrees with the FDA’s decision and is taking immediate action in response,” said Bidi Vapor founder and CEO, chief scientific officer and founder of Kaival Brands. said one Niraj Patel. “It is important to note that until then, this decision only affects ‘classic’ or tobacco-flavored BIDI sticks. The remaining 10 of his BIDI stick flavors are still undergoing FDA scientific review and will continue to be distributed in the U.S. through Kaival Brands, subject to FDA enforcement discretion. ”

Bidi Vapor has a history of success when challenging adverse FDA decisions, reversing the original MDO it received for its 10 non-tobacco flavored products in August 2022 Following a favorable Eleventh Circuit ruling. The ruling returns 10 PMTAs to scientific review and allows these flavors to continue to be sold in accordance with the FDA’s Compliance Policy for Deemed Tobacco Products. During this evaluation period, 10 non-tobacco flavored products remain under FDA enforcement discretion.

“While we are disappointed by the FDA’s decision, we remain in close contact with Bidi Vapor and remain fully committed to marketing authorized Bidi Vapor products,” said Barry M. Hopkins, Executive Chairman of Kaival Brands. he said. “Like Bidi Vapor, we are committed to the legal and responsible use of our products. Additionally, we are committed to the legal and responsible use of our products, as evidenced by the intellectual property we acquired from GoFire, Inc. in May 2023. “We are committed to increasing Kaival Brands’ revenues by strengthening our existing businesses and diversifying our product portfolio as we move forward into the course of 2024.”