Just a week after the Food and Drug Administration (FDA) denied Bidi Vapor’s PMTA for Bidi Vapor’s “Classic” tobacco-flavored ENDS device, the company has announced that it will appeal the decision alongside Kaival Brands Innovations Group.
Kaival Brands holds the worldwide license to distribute products made by Bidi Vapor.
The decision by the FDA did not involve the the 10 PMTAs for Bidi Vapor’s non-tobacco flavored devices, which are still under the FDA’s scientific review, but rather only the company’s tobacco-flavored ENDS device. Those 10 products remain available for sale through Kaival Brands, subject to FDA’s enforcement discretion.
In response to the marketing denial order (MDO), on Friday, 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 “arbitrary and capricious, in violation of the Administrative Procedure Act,” the company noted in a press release.
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, 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 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 10 non-tobacco flavored products. That ruling put the 10 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 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.”