Bidi Vapor and Kaival Appeal FDA Denial

The initial denial applies only to one Bidi device; ten other flavors still in PMTA process.

January 31, 2024

Bidi Vapor LLC and its partner Kaival Brands Innovations Group Inc. announced that the companies will appeal the FDA’s 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 January 22, the FDA issued a marketing denial order (MDO) to Bidi Vapor LLC for its classic tobacco-flavored Bidi Stick, NACS Daily reported.

This decision does not include the ten PMTAs for Bidi Vapor’s non-tobacco flavored devices that are still under the FDA’s scientific review. Those ten products remain available for sale through Kaival Brands, subject to FDA’s enforcement discretion, according to Kaival Brands.

On January 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.”

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 chief executive officer of Bidi Vapor. Patel is also the chief science officer and founder of Kaival Brands.

According to the press release, 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.

“Like Bidi Vapor, we are fully committed to the legal and responsible use of our products,” said Barry M. Hopkins, executive chairman of Kaival Brands. “We look forward to providing progress updates on our initiatives over the course of 2024.”